,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32362175,"Personalized text message and checklist support for initiation of antihypertensive medication: the cluster randomized, controlled check and support trial.","Objective:  To assess whether the use of a checklist combined with text message support improves systolic blood pressure (SBP) control. Design and setting:  A cluster randomized controlled trial in Finnish primary care. Interventions:  Personalized text message support and a checklist for initiation of antihypertensive medication. Patients:  111 newly diagnosed hypertensive patients aged 30-75 years. Main outcome measures:  The proportion of patients achieving 1) the office SBP target <140 mmHg or 2) the home SBP target <135 mmHg at 12 months. Results:  28% ( n  = 16) and 31% ( n  = 17) of patients in the intervention and control groups met the office SBP target, respectively ( p  = 0.51). The corresponding proportions were 36% ( n  = 18) and 42% ( n  = 21) for the home SBP target ( p  = 0.21). Office SBP decreased 23 mmHg (95% CI: 29-17) in the intervention group and 21 mmHg (95% CI: 27-15) in the control group ( p  = 0.61). Medication changes, number of antihypertensives at 12 months and health care utilization were similar in both study groups. Patients considered checklist and text message support useful and important. Conclusion:  Only a small proportion of patients in the intervention and control groups reached their treatment target despite multiple health care contacts and medication changes. The study interventions did not improve SBP control. However, this study demonstrates new information about hypertension control, antihypertensive medication and health service utilization during the first treatment year.",2020,Office SBP decreased 23 mmHg (95% CI: 29-17) in the intervention group and 21 mmHg (95% CI: 27-15) in the control group ( p  = 0.61).,"['Patients:  111 newly diagnosed hypertensive patients aged 30-75\u2009years', 'Finnish primary care']","['checklist combined with text message support', 'antihypertensive medication']","['SBP control', 'proportion of patients achieving 1) the office SBP target <140\u2009mmHg or 2) the home SBP', 'systolic blood pressure (SBP) control', 'Medication changes, number of antihypertensives at 12\u2009months and health care utilization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}]",,0.059699,Office SBP decreased 23 mmHg (95% CI: 29-17) in the intervention group and 21 mmHg (95% CI: 27-15) in the control group ( p  = 0.61).,"[{'ForeName': 'Aapo', 'Initials': 'A', 'LastName': 'Tahkola', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Korhonen', 'Affiliation': 'University of Turku, Turku, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Medcare Oy, Espoo, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Niiranen', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Mäntyselkä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}]",Scandinavian journal of primary health care,['10.1080/02813432.2020.1753380']
1,32350762,Reduction in pain from corticosteroid injection for the treatment of trigger finger with subcutaneous single-injection digital block: a randomized controlled trial.,"PURPOSE


The pain from corticosteroid injections is not an insignificant issue for patients with trigger finger. The aim of this study was to evaluate the efficacy of subcutaneous single-injection digital block (SSIDB) for pain reduction during trigger finger corticosteroid injection.
METHODS


Ninety patients requiring corticosteroid injections for trigger finger were randomized to three groups: SSIDB with 2 ml of 1% lidocaine, SSIDB with 1 ml of 1% lidocaine and no digital block (control group). In SSIDB groups, the intrasynovial corticosteroid injections were performed after digital nerve block. In control group, ethyl chloride spray was applied prior to intrasynovial injection of the corticosteroid and 1% lidocaine mixture. The pain during lidocaine needle insertion, lidocaine infiltration, corticosteroid needle insertion and corticosteroid infiltration were determined with a visual analog scale (VAS).
RESULTS


The VAS pain scores for corticosteroid needle insertion in both SSIDB groups were significantly lower than the VAS pain scores in control group (p < 0.001). The VAS pain score during corticosteroid infiltration in 2 ml of 1% lidocaine group was significantly lower than 1 ml of 1% lidocaine group (p = 0.008), and in control group (p < 0.001). Pain during nerve block procedure in both SSIDB groups was significantly lower than the pain from corticosteroid injection in the control group (p < 0.05 and p < 0.05).
CONCLUSIONS


Subcutaneous single-injection digital block with 2 ml of 1% lidocaine was highly effective in reducing pain associated with injection of corticosteroid for trigger finger.",2021,"Pain during nerve block procedure in both SSIDB groups was significantly lower than the pain from corticosteroid injection in the control group (p < 0.05 and p < 0.05).
","['Ninety patients requiring corticosteroid injections for trigger finger', 'patients with trigger finger']","['subcutaneous single-injection digital block (SSIDB', 'lidocaine', 'ethyl chloride spray', 'corticosteroid injection', 'lidocaine mixture', 'subcutaneous single-injection digital block', 'SSIDB with 2\xa0ml of 1% lidocaine, SSIDB with 1\xa0ml of 1% lidocaine and no digital block (control group']","['VAS pain score', 'pain reduction', 'visual analog scale (VAS', 'Pain', 'pain', 'VAS pain scores']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0158328', 'cui_str': 'Trigger finger'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0860122', 'cui_str': 'Digital block'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0015058', 'cui_str': 'Ethyl Chloride'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",90.0,0.0528223,"Pain during nerve block procedure in both SSIDB groups was significantly lower than the pain from corticosteroid injection in the control group (p < 0.05 and p < 0.05).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kosiyatrakul', 'Affiliation': 'Department of Orthopaedics, Phramongkutklao Hospital and College of Medicine, 315 Ratchawithi Road, Bangkok, 10400, Thailand. arkaphat@yahoo.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Songchou', 'Affiliation': 'Department of Orthopaedics, Phramongkutklao Hospital and College of Medicine, 315 Ratchawithi Road, Bangkok, 10400, Thailand.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Luenam', 'Affiliation': 'Department of Orthopaedics, Phramongkutklao Hospital and College of Medicine, 315 Ratchawithi Road, Bangkok, 10400, Thailand.'}]",Musculoskeletal surgery,['10.1007/s12306-020-00661-z']
2,32354299,"Ultrasound-guided versus blind subacromial bursa corticosteroid injection for paraplegic spinal cord injury patients with rotator cuff tendinopathy: a randomized, single-blind clinical trial.","INTRODUCTION


Shoulder pain is one of the common musculoskeletal complaints of the patients with spinal cord injury. Corticosteroid injection to the subacromial bursa is one of the confirmed therapies which can be guided by anatomic landmarks or ultrasound. This study is aimed to compare these two methods to find the one with the highest therapeutic impact.
MATERIALS AND METHODS


In this study, 30 patients with paraplegic SCI suffering from shoulder pain were enrolled. They were divided into 2 groups based on 4-block randomization sampling. The first group received subacromial corticosteroid injection through anatomic landmarks; while in the second group, the injection was guided by ultrasound. VAS criterion was employed for investigation of pain severity; while the constant score was used to study the shoulder pain and function. BREF questionnaire was also applied to examine the quality of life.
FINDINGS


The mean scores of VAS and Constant in both groups showed a significant improvement two months after intervention when compared with their condition before the intervention. This improvement was significantly higher in the ultrasound group. The physical, physiological and environmental health scores of BREF questionnaire as well as their total score showed a significant improvement in both groups two months after intervention. But this improvement was not significantly different between the two groups in terms of any of the items.
DISCUSSION


Hence, although ultrasound-guided injection is more costly and requires higher skills in comparison with blind injection, it is significantly more effective in controlling the pain and improving the shoulder function.",2021,The mean scores of VAS and Constant in both groups showed a significant improvement two months after intervention when compared with their condition before the intervention.,"['30 patients with paraplegic SCI suffering from shoulder pain were enrolled', 'patients with spinal cord injury', 'Discussion ', 'paraplegic spinal cord injury patients with rotator cuff tendinopathy', 'Findings ']","['Ultrasound-guided versus blind subacromial bursa corticosteroid injection', 'subacromial corticosteroid injection', 'Corticosteroid injection']","['quality of life', 'physical, physiological and environmental health scores of BREF questionnaire', 'Shoulder pain', 'mean scores of VAS and Constant']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0857021', 'cui_str': 'Paraplegic'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0224792', 'cui_str': 'Structure of subacromial bursa'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0014413', 'cui_str': 'Health, Environmental'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",30.0,0.0287807,The mean scores of VAS and Constant in both groups showed a significant improvement two months after intervention when compared with their condition before the intervention.,"[{'ForeName': 'Mohaddeseh', 'Initials': 'M', 'LastName': 'Azadvari', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Imam Khomeini and Sina Hospitals, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyede Zahra', 'Initials': 'SZ', 'LastName': 'Emami-Razavi', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Torfi', 'Affiliation': 'Resident of General Surgery, Surgical Department, Taleghani Hospital, Shahid Beheshti University of Medical Sciences,Tehran, Iran.'}, {'ForeName': 'Najmeh Sadat Boland', 'Initials': 'NSB', 'LastName': 'Nazar', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Medical and Educational Center of Taleghani Hospital,Shahid Beheshti University of Medical Sciences,Tehran, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Malekirad', 'Affiliation': 'Department of Psychology, Payame Noor University, Tehran, Iran.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1748620']
3,32362238,"Two-year weight, risk and health factor outcomes of a weight-reduction intervention programme: Primary prevention for overweight in a multicentre primary healthcare setting.","Objective:  To study the long-term effects of weight reduction, quality of life and sense of coherence in a primary health care (PHC)-based programme with two different intensities. Design:  Prospective two-armed randomised intervention. Setting:  Three PHC centres in south west of Sweden. Subjects:  In total, 289 women and men aged 40-65 years with a BMI of 28-35 were recruited for a two-year weight-reduction programme. Participants were randomized to high-intensity or low-intensity groups. Blood samples, physical measurements and questionnaires were analysed. Participants received cookbooks and dietary lectures. The high-intensity group also received Motivational interviewing (MI), dietary advice on prescription (DAP- advice), a grocery store lecture, a website and weekly e-mails. Main outcome measures:  Weight, quality of life, risks and health factors. Results:  In total, 182 (64%) participants completed the 2-year follow-up. The total sample reduced their weight by 1 kg ( p  = 0.006). No significant differences regarding weight were found between the groups. Anxiety/depression decreased in EQ5-D ( p  = 0.021), EQ5-D VAS ( p  = 0.002) and SOC ( p  = 0.042). Between the groups, there were significant differences in EQ5-D usual activities ( p  = 0.004), anxiety/depression ( p  = 0.013), pain/discomfort  (p =  0.041), fruit and vegetables ( p  = 0.005), HLV anxiety ( p  = 0.005), and visits to nurses ( p  = 0.012). Conclusion:  The total population lost weight, and the high-intensity and low-intensity programmes did not result in significant differences in terms of weight. The high-intensity programme reported health benefits linked to lower levels of anxiety and depression, increased activity and intake of greens and reduced visits to physicians and nurses.Key pointsBoth groups had a consisting weight- reduction after two years.High intensity did not lead to a significant difference in weight reduction between the groups.The high-intensity group reported more health effects, such as better quality of life, reduced anxiety, and increased greenery intake. It is unknown how much support patients in a weight- reduction programme in PHC require to succeed with weight loss and a healthy lifestyle.",2020,"Between the groups, there were significant differences in EQ5-D usual activities ( p  = 0.004), anxiety/depression ( p  = 0.013), pain/discomfort  (p =  0.041), fruit and vegetables ( p  = 0.005), HLV anxiety ( p  = 0.005), and visits to nurses ( p  = 0.012).","['Subjects', '289 women and men aged 40-65\u2009years with a BMI of 28-35 were recruited for a two-year weight-reduction programme', 'Setting:  Three PHC centres in south west of Sweden']","['weight-reduction intervention programme', 'Motivational interviewing (MI), dietary advice on prescription (DAP- advice', 'cookbooks and dietary lectures']","['Weight, quality of life, risks and health factors', 'EQ5-D usual activities', 'weight', 'HLV anxiety', 'Anxiety/depression decreased in EQ5-D', 'health effects', 'quality of life, reduced anxiety, and increased greenery intake', 'weight reduction, quality of life and sense of coherence', 'pain/discomfort', 'fruit and vegetables', 'weight reduction', 'anxiety/depression', 'EQ5-D VAS', 'total population lost weight', 'Blood samples, physical measurements and questionnaires']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0376294', 'cui_str': 'Cookbooks'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",289.0,0.038323,"Between the groups, there were significant differences in EQ5-D usual activities ( p  = 0.004), anxiety/depression ( p  = 0.013), pain/discomfort  (p =  0.041), fruit and vegetables ( p  = 0.005), HLV anxiety ( p  = 0.005), and visits to nurses ( p  = 0.012).","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bräutigam-Ewe', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lydell', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Bergh', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Hildingh', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Baigi', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Månsson', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}]",Scandinavian journal of primary health care,['10.1080/02813432.2020.1753379']
4,32382137,Transcriptomic signatures of treatment response to the combination of escitalopram and memantine or placebo in late-life depression.,"Drugs that target glutamate neuronal transmission, such as memantine, offer a novel approach to the treatment of late-life depression, which is frequently comorbid with cognitive impairment. The results of our recently published double-blind, randomized, placebo-controlled trial of escitalopram or escitalopram/memantine in late-life depression with subjective memory complaints (NCT01902004) indicated no differences between treatments in depression remission, but additional benefits in cognition at 12-month follow-up with combination treatment. To identify pathways and biological functions uniquely induced by combination treatment that may explain cognitive improvements, we generated transcriptional profiles of remission compared with non-remission from whole blood samples. Remitters to escitalopram compared with escitalopram/memantine combination treatment display unique patterns of gene expression at baseline and 6 months after treatment initiation. Functional enrichment analysis demonstrates that escitalopram-based remission associates to functions related to cellular proliferation, apoptosis, and inflammatory response. Escitalopram/memantine-based remission, however, is characterized by processes related to cellular clearance, metabolism, and cytoskeletal dynamics. Both treatments modulate inflammatory responses, albeit via different effector pathways. Additional research is needed to understand the implications of these results in explaining the observed superior effects of combination treatment on cognition observed with prolonged treatment.",2021,Remitters to escitalopram compared with escitalopram/memantine combination treatment display unique patterns of gene expression at baseline and 6 months after treatment initiation.,['late-life depression'],"['escitalopram and memantine or placebo', 'placebo', 'escitalopram or escitalopram/memantine', 'escitalopram/memantine', 'Escitalopram/memantine']",['gene expression'],"[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}]",,0.354835,Remitters to escitalopram compared with escitalopram/memantine combination treatment display unique patterns of gene expression at baseline and 6 months after treatment initiation.,"[{'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Grzenda', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Pscyhiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Siddarth', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Pscyhiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Kelsey T', 'Initials': 'KT', 'LastName': 'Laird', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Pscyhiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Yeargin', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Pscyhiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lavretsky', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Pscyhiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, CA, USA. hlavretsky@mednet.ucla.edu.'}]",Molecular psychiatry,['10.1038/s41380-020-0752-2']
5,32375905,"Effect of the NMDA receptor partial agonist, d-cycloserine, on emotional processing and autobiographical memory.","BACKGROUND


Studies suggest that d-cycloserine (DCS) may have antidepressant potential through its interaction with the glycine site of the N-methyl-D-aspartate receptor; however, clinical evidence of DCS's efficacy as a treatment for depression is limited. Other evidence suggests that DCS affects emotional learning which may also be relevant for the treatment of depression and anxiety. The aim of the present investigation was to assess the effect of DCS on emotional processing in healthy volunteers and to further characterise its effects on emotional and autobiographical memory.
METHODS


Forty healthy volunteers were randomly allocated to a single dose of 250 mg DCS or placebo in a double-blind design. Three hours later, participants performed an Emotional Test Battery [including Facial Expression Recognition Task (FERT), Emotional Categorisation Task (ECAT), Emotional Recall Task (EREC), Facial Dot-Probe Task (FDOT) and Emotional Recognition Memory Task (EMEM)] and an Autobiographical Memory Test (AMT). Also, participants performed the FERT, EREC and AMT tasks again after 24 h in order to assess longer lasting effects of a single dose of DCS.
RESULTS


DCS did not significantly affect the FERT, EMEM and FDOT performance but significantly increased emotional memory and classification for positive words v. negative words. Also, DCS enhanced the retrieval of more specific autobiographical memories, and this effect persisted at 24 h.
CONCLUSIONS


These findings support the suggestion that low-dose DCS increases specific autobiographical memory retrieval and positive emotional memory. Such effects make it an intriguing agent for further investigation in clinical depression, which is characterised by decreased autobiographical memory specificity and increased negative bias in memory recall. It also underscores the potential role of DCS as an adjunct to cognitive behavioural therapy in depression.",2021,"RESULTS


DCS did not significantly affect the FERT, EMEM and FDOT performance but significantly increased emotional memory and classification for positive words v. negative words.","['Forty healthy volunteers', 'healthy volunteers']","['NMDA receptor partial agonist, d-cycloserine', 'd-cycloserine (DCS', 'DCS', 'DCS or placebo']","['specific autobiographical memory retrieval and positive emotional memory', 'emotional processing and autobiographical memory', 'retrieval of more specific autobiographical memories', 'FERT, EMEM and FDOT performance', 'Emotional Test Battery [including Facial Expression Recognition Task (FERT), Emotional Categorisation Task (ECAT), Emotional Recall Task (EREC), Facial Dot-Probe Task (FDOT) and Emotional Recognition Memory Task (EMEM)] and an Autobiographical Memory Test (AMT', 'emotional memory and classification for positive words v. negative words']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",40.0,0.412262,"RESULTS


DCS did not significantly affect the FERT, EMEM and FDOT performance but significantly increased emotional memory and classification for positive words v. negative words.","[{'ForeName': 'Runsen', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'University Department of Psychiatry, Warneford Hospital, University of Oxford, OX3 7JX, UK.'}, {'ForeName': 'Liliana P', 'Initials': 'LP', 'LastName': 'Capitão', 'Affiliation': 'University Department of Psychiatry, Warneford Hospital, University of Oxford, OX3 7JX, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': 'University Department of Psychiatry, Warneford Hospital, University of Oxford, OX3 7JX, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'University Department of Psychiatry, Warneford Hospital, University of Oxford, OX3 7JX, UK.'}]",Psychological medicine,['10.1017/S0033291720001221']
6,32369546,Empagliflozin for Patients With Presumed Resistant Hypertension: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial.,"BACKGROUND


Type 2 diabetes (T2D) and resistant hypertension often coexist, greatly increasing risk of target-organ damage and death. We explored the effects of empagliflozin in patients with and without presumed resistant hypertension (prHT) in a post hoc analysis of EMPA-REG OUTCOME (NCT01131676).
METHODS


Overall, 7,020 patients received empagliflozin 10, 25 mg, or placebo with median follow-up of 3.1 years. We defined baseline prHT as ≥3 classes of antihypertensive drugs including a diuretic and uncontrolled blood pressure (BP; systolic blood pressure (SBP) ≥140 and/or diastolic blood pressure ≥90 mm Hg) or ≥4 classes of antihypertensive, including a diuretic, and controlled BP. We explored the effect of empagliflozin on cardiovascular (CV) death, heart failure (HF) hospitalization, 3-point major adverse cardiac events, all-cause death, and incident/worsening nephropathy by Cox regression and BP over time by a mixed-repeated-measures-model analysis.
RESULTS


1,579 (22.5%) patients had prHT. The mean difference in change in SBP from baseline to week 12 vs. placebo was -4.5 (95% confidence interval, -5.9 to -3.1) mm Hg (P < 0.001) in prHT and -3.7 (-4.5, -2.9) mm Hg (P < 0.001) in patients without prHT. SBP was more frequently controlled (<130/80 mm Hg) with empagliflozin than with placebo. Patients with prHT had 1.5- to 2-fold greater risk of HF hospitalization, incident/worsening nephropathy, and CV death compared with those without prHT. Empagliflozin improved all outcomes in patients with and without prHT (interaction P > 0.1 for all outcomes).
CONCLUSIONS


Empagliflozin induced a clinically relevant reduction in SBP and consistently improved all outcomes regardless of prHT status. Due to these dual effects, empagliflozin should be considered for patients with hypertension and T2D.",2020,"Empagliflozin improved all outcomes in patients with and without prHT (interaction P>0.1 for all outcomes).
","['patients with and without presumed resistant hypertension (prHT', '1579 (22.5%) patients had prHT', 'patients with hypertension and T2D', '7020 patients received', 'Patients with Presumed Resistant Hypertension']","['Empagliflozin', 'prHT', 'empagliflozin', 'placebo']","['CV death, heart failure hospitalization (HHF), 3-point major adverse cardiac events (3P-MACE), all-cause death, and incident/worsening nephropathy by Cox regression and BP over time', 'risk of HHF, incident/worsening nephropathy and CV death', 'SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]",,0.156709,"Empagliflozin improved all outcomes in patients with and without prHT (interaction P>0.1 for all outcomes).
","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Bettina Johanna', 'Initials': 'BJ', 'LastName': 'Kraus', 'Affiliation': 'Comprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Lauer', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France.""}]",American journal of hypertension,['10.1093/ajh/hpaa073']
7,32378932,Understanding motives for and against hazardous drinking and change among returning veterans.,"The prevalence of hazardous drinking is elevated among returning veterans of Iraq and Afghanistan wars, particularly among returning veterans and those with co-occurring posttraumatic stress disorder (PTSD) symptoms. Understanding the reasons for drinking as well as motivations for change can tremendously improve intervention efforts. Unfortunately, little is currently known regarding the motivations that might facilitate or hinder change among returning veterans. In the current study, we examined returning veterans' reasons to change or not change drinking through analysis of responses to an open-ended decisional balance exercise. We included 366 returning veterans selected from a larger sample of returning veterans enrolled in a web-based randomized-controlled trial of an online intervention for alcohol use and PTSD. We used qualitative content analysis to systematically classify responses into categories through identification of common themes. Top reasons to change/reduce drinking included reducing negative physical effects, improve finances, and expected social/interpersonal benefits of reduction or abstaining. Top reasons to continue drinking/not change included facilitation of social interaction, promote sleep, and reduce tension. The current study adds to our phenomenological understanding of motivations for and against changing drinking among returning veterans. Whereas many motives were consistent with those of nonveteran samples, others appear to distinguish, and are uniquely salient among, returning veterans (e.g., to manage sleep and PTSD symptoms). These results provide insight into key assessment and intervention points regarding hazardous drinking among returning veterans. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"The prevalence of hazardous drinking is elevated among returning veterans of Iraq and Afghanistan wars, particularly among returning veterans and those with co-occurring posttraumatic stress disorder (PTSD) symptoms.","['returning veterans', '366 returning veterans selected from a larger sample of returning veterans enrolled in a web-based randomized-controlled trial of an']",['online intervention for alcohol use and PTSD'],"['negative physical effects, improve finances, and expected social/interpersonal benefits of reduction or abstaining']","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0121099,"The prevalence of hazardous drinking is elevated among returning veterans of Iraq and Afghanistan wars, particularly among returning veterans and those with co-occurring posttraumatic stress disorder (PTSD) symptoms.","[{'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Schreiner', 'Affiliation': 'VA Boston Healthcare System.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Livingston', 'Affiliation': 'National Center for PTSD.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Heilman', 'Affiliation': 'National Center for PTSD.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Lynch', 'Affiliation': 'Massachusetts General Hospital.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vittorio', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Brief', 'Affiliation': 'VA Boston Healthcare System.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Rubin', 'Affiliation': 'VA Boston Healthcare System.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Enggasser', 'Affiliation': 'VA Boston Healthcare System.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'VA Boston Healthcare System.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Solhan', 'Affiliation': 'VA Boston Healthcare System.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Helmuth', 'Affiliation': 'Education Development Center.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenbloom', 'Affiliation': 'Department of Health Policy and Management.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'National Center for PTSD.'}]",Psychological services,['10.1037/ser0000423']
8,28263370,Fixed-dose combination therapy for the prevention of atherosclerotic cardiovascular diseases.,"BACKGROUND


Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death and disability worldwide, yet ASCVD risk factor control and secondary prevention rates remain low. A fixed-dose combination of blood pressure- and cholesterol-lowering and antiplatelet treatments into a single pill, or polypill, has been proposed as one strategy to reduce the global burden of ASCVD.
OBJECTIVES


To determine the effect of fixed-dose combination therapy on all-cause mortality, fatal and non-fatal ASCVD events, and adverse events. We also sought to determine the effect of fixed-dose combination therapy on blood pressure, lipids, adherence, discontinuation rates, health-related quality of life, and costs.
SEARCH METHODS


We updated our previous searches in September 2016 of CENTRAL, MEDLINE, Embase, ISI Web of Science, and DARE, HTA, and HEED. We also searched two clinical trials registers in September 2016. We used no language restrictions.
SELECTION CRITERIA


We included randomised controlled trials of a fixed-dose combination therapy including at least one blood pressure-lowering and one lipid-lowering component versus usual care, placebo, or an active drug comparator for any treatment duration in adults 18 years old or older, with no restrictions on presence or absence of pre-existing ASCVD.
DATA COLLECTION AND ANALYSIS


Three review authors independently selected studies for inclusion and extracted the data for this update. We evaluated risk of bias using the Cochrane 'Risk of bias' assessment tool. We calculated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous data with 95% confidence intervals (CI) using fixed-effect models when heterogeneity was low (I 2  < 50%) and random-effects models when heterogeneity was high (I 2  ≥ 50%). We used the GRADE approach to evaluate the quality of evidence.
MAIN RESULTS


In the initial review, we identified nine randomised controlled trials with a total of 7047 participants and four additional trials (n = 2012 participants; mean age range 62 to 63 years; 30% to 37% women) were included in this update. Eight of the 13 trials evaluated the effects of fixed-dose combination (FDC) therapy in populations without prevalent ASCVD, and the median follow-up ranged from six weeks to 23 months. More recent trials were generally larger with longer follow-up and lower risk of bias. The main risk of bias was related to lack of blinding of participants and personnel, which was inherent to the intervention. Compared with the comparator groups (placebo, usual care, or active drug comparator), the effects of the fixed-dose combination treatment on mortality (FDC = 1.0% versus control = 1.0%, RR 1.10, 95% CI 0.64 to 1.89,  I 2  = 0%, 5 studies, N = 5300) and fatal and non-fatal ASCVD events (FDC = 4.7% versus control = 3.7%, RR 1.26, 95% CI 0.95 to 1.66, I 2  = 0%, 6 studies, N = 4517) were uncertain (low-quality evidence). The low event rates for these outcomes and indirectness of evidence for comparing fixed-dose combination to usual care versus individual drugs suggest that these results should be viewed with caution. Adverse events were common in both the intervention (32%) and comparator (27%) groups, with participants randomised to fixed-dose combination therapy being 16% (RR 1.16, 95% CI 1.09 to 1.25, 11 studies, 6906 participants, moderate-quality evidence) more likely to report an adverse event . The mean differences in systolic blood pressure between the intervention and control arms was -6.34 mmHg (95% CI -9.03 to -3.64, 13 trials, 7638 participants, moderate-quality evidence). The mean differences (95% CI) in total and LDL cholesterol between the intervention and control arms were -0.61 mmol/L (95% CI -0.88 to -0.35, 11 trials, 6565 participants, low-quality evidence) and -0.70 mmol/L (95% CI -0.98 to -0.41, 12 trials, 7153 participants, moderate-quality evidence), respectively. There was a high degree of statistical heterogeneity in comparisons of blood pressure and lipids (I 2  ≥ 80% for all) that could not be explained, so these results should be viewed with caution. Fixed-dose combination therapy improved adherence to a multidrug strategy by 44% (26% to 65%) compared with usual care (4 trials, 3835 participants, moderate-quality evidence).
AUTHORS' CONCLUSIONS


The effects of fixed-dose combination therapy on all-cause mortality or ASCVD events are uncertain. A limited number of trials reported these outcomes, and the included trials were primarily designed to observe changes in ASCVD risk factor levels rather than clinical events, which may partially explain the observed differences in risk factors that were not translated into differences in clinical outcomes among the included trials. Fixed-dose combination therapy is associated with modest increases in adverse events compared with placebo, active comparator, or usual care but may be associated with improved adherence to a multidrug regimen. Ongoing, longer-term trials of fixed-dose combination therapy will help demonstrate whether short-term changes in risk factors might be maintained and lead to expected differences in clinical events based on these changes.",2017,"Fixed-dose combination therapy is associated with modest increases in adverse events compared with placebo, active comparator, or usual care but may be associated with improved adherence to a multidrug regimen.","['adults 18 years old or older, with no restrictions on presence or absence of pre-existing ASCVD', '7047 participants and four additional trials (n = 2012 participants; mean age range 62 to 63 years; 30% to 37% women']","['Fixed-dose combination therapy', 'fixed-dose combination therapy including at least one blood pressure-lowering and one lipid-lowering component versus usual care, placebo, or an active drug comparator', 'fixed-dose combination (FDC) therapy']","['total and LDL cholesterol', 'blood pressure and lipids', 'Adverse events', 'adherence to a multidrug strategy', 'cause mortality, fatal and non-fatal ASCVD events, and adverse events', 'calculated risk ratios (RR', 'adverse events', 'fatal and non-fatal ASCVD events', 'systolic blood pressure', 'blood pressure, lipids, adherence, discontinuation rates, health-related quality of life, and costs', 'mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",4517.0,0.564458,"Fixed-dose combination therapy is associated with modest increases in adverse events compared with placebo, active comparator, or usual care but may be associated with improved adherence to a multidrug regimen.","[{'ForeName': 'Ehete', 'Initials': 'E', 'LastName': 'Bahiru', 'Affiliation': 'Internal Medicine; Division of Cardiology, Northwestern University, 201 E. Huron St. Galter 19-100, Chicago, Illinois, USA, 60611.'}, {'ForeName': 'Angharad N', 'Initials': 'AN', 'LastName': 'de Cates', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK, CV4 7AL.'}, {'ForeName': 'Matthew Rb', 'Initials': 'MR', 'LastName': 'Farr', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK, CV4 7AL.'}, {'ForeName': 'Morag C', 'Initials': 'MC', 'LastName': 'Jarvis', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK, CV4 7AL.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Palla', 'Affiliation': 'Department of Medicine, Wayne State University, 540 E Canfield St, Detroit, Michigan, USA, 48201.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rees', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK, CV4 7AL.'}, {'ForeName': 'Shah', 'Initials': 'S', 'LastName': 'Ebrahim', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, Keppel Street, London, UK, WC1E 7HT.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Huffman', 'Affiliation': 'Departments of Preventive Medicine and Medicine (Cardiology), Northwestern University Feinberg School of Medicine, 680 N. Lake Shore Drive, Suite 1400, Chicago, IL, USA, 60611.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009868.pub3']
9,32398500,The Effect of Rehospitalization and Emergency Department Visits on Subsequent Adherence to Weight Telemonitoring.,"BACKGROUND


Weight telemonitoring may be an effective way to improve patients' ability to manage heart failure and prevent unnecessary utilization of health services. However, the effectiveness of such interventions is dependent upon patient adherence.
OBJECTIVE


The purpose of this study was to determine how adherence to weight telemonitoring changes in response to 2 types of events: hospital readmissions and emergency department visits.
METHODS


The Better Effectiveness After Transition-Heart Failure trial examined the effectiveness of a remote telemonitoring intervention compared with usual care for patients discharged to home after hospitalization for decompensated heart failure. Participants were followed for 180 days and were instructed to transmit weight readings daily. We used Poisson regression to determine the within-person effects of events on subsequent adherence.
RESULTS


A total of 625 events took place during the study period. Most of these events were rehospitalizations (78.7%). After controlling for the number of previous events and discharge to a skilled nursing facility, the rate for adherence decreased by nearly 20% in the 2 weeks after a hospitalization compared with the 2 weeks before (adjusted rate ratio, 0.81; 95% confidence interval: 0.77-0.86; P < .001).
CONCLUSIONS


Experiencing a rehospitalization had the effect of diminishing adherence to daily weighing. Providers using telemonitoring to monitor decompensation and manage medications should take advantage of the potential ""teachable moment"" during hospitalization to reinforce the importance of adherence.",2021,The Better Effectiveness,['patients discharged to home after hospitalization for decompensated heart failure'],['remote telemonitoring intervention'],"['Better Effectiveness', 'rate for adherence']","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0488464,The Better Effectiveness,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Haynes', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Hoch', 'Affiliation': ''}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': ''}, {'ForeName': 'Theodore G', 'Initials': 'TG', 'LastName': 'Ganiats', 'Affiliation': ''}, {'ForeName': 'Lorraine S', 'Initials': 'LS', 'LastName': 'Evangelista', 'Affiliation': ''}, {'ForeName': 'Jeanne T', 'Initials': 'JT', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Auerbach', 'Affiliation': ''}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Romano', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000689']
10,32329986,Transcranial magnetic stimulation over the right temporoparietal junction influences the sense of agency in healthy humans.,"Background


The sense of agency is an important aspect of motor control. Impaired sense of agency has been linked to several medical conditions, including schizophrenia and functional neurological disorders. A complex brain network subserves the sense of agency, and the right temporoparietal junction is one of its main nodes. In this paper, we tested whether transcranial magnetic stimulation over the right temporoparietal junction elicited behavioural changes in the sense of agency.
Methods


In experiment 1, 15 healthy participants performed a behavioural task during functional MRI, with the goal of localizing the area relevant for the sense of agency in the right temporoparietal junction. In the task, the movement of a cursor (controlled by the participants) was artificially manipulated, and the sense of agency was either diminished (turbulence) or enhanced (magic). In experiment 2, we applied transcranial magnetic stimulation in 20 healthy participants in a sham-controlled, crossover trial with excitatory, inhibitory or sham (vertex) stimulation. We measured the summary agency score, an indicator of the sense of agency (lower values correspond to diminished sense of agency).
Results


Experiment 1 revealed a peak of activation during agency manipulation in the right temporoparietal junction (Montreal Neurological Institute coordinates x, y, z: 68, -26, 34). Experiment 2 showed that inhibition of the right temporoparietal junction significantly reduced the summary agency score in both turbulence (from -14.4 ± 11.4% to -22.5 ± 8.9%), and magic (from -0.7 ± 5.8% to -4.4 ± 4.4%).
Limitations


We found no excitatory effects, possibly because of a ceiling effect (because healthy participants have a normal sense of agency) or noneffectiveness of the excitatory protocol.
Conclusion


Our experiments showed that the network subserving the sense of agency was amenable to neuromodulation in healthy participants. This sets the ground for further research in patients with impaired sense of agency. Clinical trial identification: DRKS00012992 (German clinical trials registry).",2020,"We found no excitatory effects, possibly because of a ceiling effect (because healthy participants have a normal sense of agency) or noneffectiveness of the excitatory protocol.
","['15 healthy participants', 'patients with impaired sense of agency', '20 healthy participants', 'healthy participants', 'healthy humans']","['excitatory, inhibitory or sham (vertex) stimulation', 'Transcranial magnetic stimulation', 'transcranial magnetic stimulation']","['inhibition of the right temporoparietal junction', 'summary agency score']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0370275,"We found no excitatory effects, possibly because of a ceiling effect (because healthy participants have a normal sense of agency) or noneffectiveness of the excitatory protocol.
","[{'ForeName': 'Giuseppe A', 'Initials': 'GA', 'LastName': 'Zito', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Anderegg', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'Kallia', 'Initials': 'K', 'LastName': 'Apazoglou', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Müri', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wiest', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'Martin Grosse', 'Initials': 'MG', 'LastName': 'Holtforth', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Aybek', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.190099']
11,30973970,"Investigation of the absolute bioavailability and human mass balance of navoximod, a novel IDO1 inhibitor.","AIMS


Navoximod (GDC-0919, NLG-919) is a small molecule inhibitor of indoleamine-2,3-dioxygenase 1 (IDO1), developed to treat the acquired immune tolerance associated with cancer. The primary objectives of this study were to assess navoximod's absolute bioavailability (aBA), determine the mass balance and routes of elimination of [ 14  C]-navoximod, and characterize navoximod's metabolite profile.
METHODS


A phase 1, open-label, two-part study was conducted in healthy volunteers. In Part 1 (aBA), subjects (n = 16) were randomized to receive oral (200 mg tablet) or intravenous (5 mg solution) navoximod in a crossover design with a 5-day washout. In Part 2 (mass balance), subjects (n = 8) were administered [ 14  C]-navoximod (200 mg/600 μCi) as an oral solution.
RESULTS


The aBA of navoximod was estimated to be 55.5%, with a geometric mean (%CV) plasma clearance and volume of distribution of 62.0 L/h (21.0%) and 1120 L (28.4%), respectively. Mean recovery of total radioactivity was 87.8%, with 80.4% detected in urine and the remainder (7.4%) in faeces. Navoximod was extensively metabolized, with unchanged navoximod representing 5.45% of the dose recovered in the urine and faeces. Glucuronidation was identified as the primary route of metabolism, with the major glucuronide metabolite, M28, accounting for 57.5% of the total drug-derived exposure and 59.7% of the administered dose recovered in urine.
CONCLUSIONS


Navoximod was well tolerated, quickly absorbed and showed moderate bioavailability, with minimal recovery of the dose as unchanged parent in the urine and faeces. Metabolism was identified as the primary route of clearance and navoximod glucuronide (M28) was the most abundant metabolite in circulation with all other metabolites accounting for <10% of drug-related exposure.",2019,"Navoximod was extensively metabolized, with unchanged navoximod representing 5.45% of the dose recovered in the urine and faeces.","['In Part 1 (aBA), subjects (n\xa0=\xa016', 'healthy volunteers']","['oral (200\xa0mg tablet) or intravenous (5\xa0mg solution) navoximod', 'Navoximod (GDC-0919, NLG-919']","['aBA of navoximod', 'geometric mean (%CV) plasma clearance and volume of distribution', 'moderate bioavailability', ""navoximod's absolute bioavailability (aBA), determine the mass balance and routes of elimination of [ 14  C]-navoximod, and characterize navoximod's metabolite profile"", 'Mean recovery of total radioactivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0302945', 'cui_str': 'Carbon-14'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034553', 'cui_str': 'Radioactive Disintegration'}]",16.0,0.0384553,"Navoximod was extensively metabolized, with unchanged navoximod representing 5.45% of the dose recovered in the urine and faeces.","[{'ForeName': 'Shuguang', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Suchomel', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Yanez', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Yost', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Hoa', 'Initials': 'H', 'LastName': 'Le', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Siebers', 'Affiliation': 'Covance Clinical Research Unit, 3402 Kinsman Boulevard, Madison, WI, 53704, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Joas', 'Affiliation': 'Covance Clinical Research Unit, 3402 Kinsman Boulevard, Madison, WI, 53704, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Morley', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Royer-Joo', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pirzkall', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Salphati', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ware', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Kari M', 'Initials': 'KM', 'LastName': 'Morrissey', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.13961']
12,31957953,Early phase 2 trial of TAS-205 in patients with Duchenne muscular dystrophy.,"OBJECTIVE


Duchenne muscular dystrophy (DMD) is a progressive muscular disease characterized by chronic cycles of inflammatory and necrotic processes. Prostaglandin D 2  (PGD 2  ) is produced by hematopoietic PGD synthase (HPGDS), which is pathologically implicated in muscle necrosis. This randomized, double-blind, placebo-controlled early phase 2 study (NCT02752048) aimed to assess the efficacy and safety of the novel selective HPGDS inhibitor, TAS-205, with exploratory measures in male DMD patients aged ≥5 years.
METHODS


Patients were randomized 1:1:1 to receive low-dose TAS-205 (6.67-13.33 mg/kg/dose), high-dose TAS-205 (13.33-26.67 mg/kg/dose), or placebo. The primary endpoint was the change from baseline in a 6-minute walk distance (6MWD) at Week 24.
RESULTS


Thirty-six patients were enrolled, of whom 35 patients were analysed for safety. The mean (standard error) changes from baseline to Week 24 in 6MWD were -17.0 (17.6) m in the placebo group (n = 10), -3.5 (20.3) m in the TAS-205 low-dose group (n = 11), and -7.5 (11.2) m in the TAS-205 high-dose group (n = 11). The mean (95% confidence interval) difference from the placebo group was 13.5 (-43.3 to 70.2) m in the TAS-205 low-dose group and 9.5 (-33.3 to 52.4) m in the TAS-205 high-dose group. No obvious differences were observed in the incidences of adverse events between treatment groups. No adverse drug reactions specific to TAS-205 treatment were observed.
INTERPRETATION


The HPGDS inhibitor TAS-205 showed a favorable safety profile in DMD patients. Further research is required to examine the effectiveness of TAS-205 in a larger trial.",2020,No adverse drug reactions specific to,"['DMD patients', 'male DMD patients aged ≥5\xa0years', 'Patients', 'patients with Duchenne muscular dystrophy', 'Thirty-six patients were enrolled, of whom 35 patients were analysed for safety']","['placebo', 'novel selective HPGDS inhibitor, TAS-205', 'Duchenne muscular dystrophy (DMD', 'TAS-205', 'Prostaglandin D 2  (PGD 2  ', 'HPGDS inhibitor', 'high-dose TAS-205', 'low-dose TAS-205']","['efficacy and safety', 'change from baseline in a 6-minute walk distance (6MWD', 'adverse events']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013264', 'cui_str': 'Cardiomyopathy, Dilated, X-Linked'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013264', 'cui_str': 'Cardiomyopathy, Dilated, X-Linked'}, {'cui': 'C0033558', 'cui_str': 'PGD'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",36.0,0.414167,No adverse drug reactions specific to,"[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Komaki', 'Affiliation': 'Department of Child Neurology, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Maegaki', 'Affiliation': 'Division of Child Neurology, Department of Brain and Neurosciences, Faculty of Medicine, Tottori University, Tottori, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Matsumura', 'Affiliation': 'Department of Neurology, National Hospital Organization Osaka Toneyama Medical Center, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Awano', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Third Department of Medicine, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Niigata National Hospital, Niigata, Japan.'}, {'ForeName': 'Katsuhisa', 'Initials': 'K', 'LastName': 'Ogata', 'Affiliation': 'Department of Neurology, National Hospital Organization Higashisaitama National Hospital, Saitama, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ishigaki', 'Affiliation': ""Department of Pediatrics, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Saitoh', 'Affiliation': 'Department of Pediatrics and Neonatology, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.'}, {'ForeName': 'Michinori', 'Initials': 'M', 'LastName': 'Funato', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Nagara Medical Center, Gifu, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kuru', 'Affiliation': 'Department of Neurology, National Hospital Organization Suzuka National Hospital, Mie, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Department of Neurology, Division of Neuromuscular diseases, Yokohama Rosai Hospital, Kanagawa, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Iwata', 'Affiliation': 'Department of Rehabilitation, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yajima', 'Affiliation': 'Department of Rehabilitation, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': ""Shin'ichi"", 'Initials': 'S', 'LastName': 'Takeda', 'Affiliation': 'National Center of Neurology and Psychiatry, Tokyo, Japan.'}]",Annals of clinical and translational neurology,['10.1002/acn3.50978']
13,30768419,"Reducing Preschool Behavior Problems in an Urban Mental Health Clinic: A Pragmatic, Non-Inferiority Trial.","OBJECTIVE


This pragmatic, randomized, non-inferiority trial compared the effectiveness and cost of group-based parent management training with mastery-based individual coaching parent management training in a low-income, predominantly African American sample.
METHOD


Parents seeking treatment for their 2- to 5-year-old children's behavior problems in an urban fee-for-service child mental health clinic were randomized to the Chicago Parent Program (CPP; n = 81) or Parent-Child Interaction Therapy (PCIT; n = 80). Consent followed clinic intake and diagnostic assessment and parent management training was delivered by clinicians employed at the clinic. Primary outcome measures were externalizing child behavior problems, assessed at baseline and postintervention follow-up, using the Child Behavior Checklist (CBCL) and average per-participant treatment cost.
RESULTS


Data from 158 parents were analyzed. Most were mothers (75.9%), African American (70.3%), and economically disadvantaged (98.7% Medicaid insured). Of children, 58.2% were boys, and mean age was 3.6 years (SD 1.03). Based on CBCL scores, behavior problems improved in the 2 conditions (Cohen d = 0.57 for CPP and 0.50 for PCIT). CPP was not inferior to PCIT (90% CI -1.58 to 4.22) at follow-up, even after controlling for differences in treatment length (90% CI -1.63 to 4.87). Average per-participant treatment cost was higher for PCIT (mean $2,151) than for CPP (mean $1,413, 95% CI -1,304 to -170).
CONCLUSION


For parents of young children living in urban poverty, CPP is not inferior to PCIT for decreasing child behavior problems. CPP requires less time to complete and costs a third less than PCIT.
CLINICAL TRIAL REGISTRATION INFORMATION


Early Parenting Intervention Comparison (EPIC); https://clinicaltrials.gov/; NCT01517867.",2019,"CPP was not inferior to PCIT (90% CI -1.58 to 4.22) at follow-up, even after controlling for differences in treatment length (90% CI -1.63 to 4.87).","['Urban Mental Health Clinic', ""Parents seeking treatment for their 2- to 5-year-old children's behavior problems in an urban fee-for-service child mental health clinic"", 'Data from 158 parents were analyzed', 'a low-income, predominantly African American sample', 'Most were mothers (75.9%), African American (70.3%), and economically disadvantaged (98.7% Medicaid insured', 'Of children, 58.2% were boys, and mean age was 3.6 years (SD 1.03']","['CPP', 'group-based parent management training with mastery-based individual coaching parent management training', 'Chicago Parent Program (CPP; n\xa0= 81) or Parent-Child Interaction Therapy (PCIT', 'Early Parenting Intervention Comparison (EPIC']","['externalizing child behavior problems, assessed at baseline and postintervention follow-up, using the Child Behavior Checklist (CBCL) and average per-participant treatment cost', 'CBCL scores, behavior problems', 'Average per-participant treatment cost']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0242816', 'cui_str': 'Fees for Service'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",158.0,0.142358,"CPP was not inferior to PCIT (90% CI -1.58 to 4.22) at follow-up, even after controlling for differences in treatment length (90% CI -1.63 to 4.87).","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Gross', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD. Electronic address: debgross@jhu.edu.'}, {'ForeName': 'Harolyn M E', 'Initials': 'HME', 'LastName': 'Belcher', 'Affiliation': 'Kennedy-Krieger Institute, Baltimore.'}, {'ForeName': 'Chakra', 'Initials': 'C', 'LastName': 'Budhathoki', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD.'}, {'ForeName': 'Mirian E', 'Initials': 'ME', 'LastName': 'Ofonedu', 'Affiliation': 'Kennedy-Krieger Institute; Maryland Center for Developmental Disabilities, Windsor Mill.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Dutrow', 'Affiliation': 'Kennedy-Krieger Institute, Baltimore.'}, {'ForeName': 'Melissa Kurtz', 'Initials': 'MK', 'LastName': 'Uveges', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Slade', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD; University of Maryland School of Medicine, Baltimore; US Department of Veteran Affairs VISN5 MIRECC, Baltimore.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.08.013']
14,32040038,Bundling Rapid Human Immunodeficiency Virus and Hepatitis C Virus Testing to Increase Receipt of Test Results: A Randomized Trial.,"BACKGROUND


The overlapping human immunodeficiency virus (HIV) and hepatitis C virus (HCV) epidemics disproportionately affect people with substance use disorders. However, many people who use substances remain unaware of their infection(s).
OBJECTIVE


The objective of this study was to examine the efficacy of an on-site bundled rapid HIV and HCV testing strategy in increasing receipt of both HIV and HCV test results.
RESEARCH DESIGN


Two-armed randomized controlled trial in substance use disorder treatment programs (SUDTP) in New York City. Participants in the treatment arm were offered bundled rapid HIV and HCV tests with immediate results on-site. Participants in the control arm were offered the standard of care, that is, referrals to on-site or off-site laboratory-based HIV and HCV testing with delayed results.
PARTICIPANTS


A total of 162 clients with unknown or negative HIV and HCV status.
MEASURES


The primary outcome was the percentage of participants with self-reported receipt of HIV and HCV test results at 1-month postrandomization.
RESULTS


Over half of participants were Hispanic (51.2%), with 25.3% being non-Hispanic black and 17.9% non-Hispanic white. Two thirds were male, and 54.9% reported injection as method of drug use. One hundred thirty-four participants (82.7%) completed the 1-month assessment. Participants in the treatment arm were more likely to report having received both test results than those in the control arm (69% vs. 19%, P<0.001). Seven participants in the treatment arm received a preliminary new HCV diagnosis, versus 1 in the control arm (P=0.029).
CONCLUSION


Offering bundled rapid HIV and HCV testing with immediate results on-site in SUDTPs may increase awareness of HIV and HCV infection among people with substance use disorders.",2020,"Seven participants in the treatment arm received a preliminary new HCV diagnosis, versus 1 in the control arm (P=0.029).
","['people with substance use disorders', 'A total of 162 clients with unknown or negative HIV and HCV status', 'One hundred thirty-four participants (82.7%) completed the 1-month assessment']",[],"['HIV and HCV infection', 'percentage of participants with self-reported receipt of HIV and HCV test results']","[{'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",[],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",162.0,0.0980228,"Seven participants in the treatment arm received a preliminary new HCV diagnosis, versus 1 in the control arm (P=0.029).
","[{'ForeName': 'Jemima A', 'Initials': 'JA', 'LastName': 'Frimpong', 'Affiliation': 'The Johns Hopkins Carey Business School, Baltimore, MD.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Shiu-Yee', 'Affiliation': 'Columbia University Mailman School of Public Health.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tross', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies Division of Gender, Sexuality, and Health New York State Psychiatric Institute and Columbia University.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""D'Aunno"", 'Affiliation': 'NYU Wagner Graduate School of Public Service.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Perlman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Shiela M', 'Initials': 'SM', 'LastName': 'Strauss', 'Affiliation': 'NYU Rory Meyers College of Nursing.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Columbia University Mailman School of Public Health.'}]",Medical care,['10.1097/MLR.0000000000001311']
15,31630117,"Sustained discontinuation of infliximab with a raising-dose strategy after obtaining remission in patients with rheumatoid arthritis: the RRRR study, a randomised controlled trial.","OBJECTIVES


The aim of this study is to determine whether the 'programmed' infliximab (IFX) treatment strategy (for which the dose of IFX was adjusted based on the baseline serum tumour necrosis factor α (TNF-α)) is beneficial to induction of clinical remission after 54 weeks and sustained discontinuation of IFX for 1 year.
METHODS


In this multicentre randomised trial, patients with IFX-naïve rheumatoid arthritis with inadequate response to methotrexate were randomised to two groups; patients in programmed treatment group received 3 mg/kg IFX until week 6 and after 14 weeks the dose of IFX was adjusted based on the baseline levels of serum TNF-α until week 54; patients in the standard treatment group received 3 mg/kg of IFX. Patients who achieved a simplified disease activity index (SDAI) ≤3.3 at week 54 discontinued IFX. The primary endpoint was the proportion of patients who sustained discontinuation of IFX at week 106.
RESULTS


A total of 337 patients were randomised. At week 54, 39.4% (67/170) in the programmed group and 32.3% (54/167) in the standard group attained remission (SDAI ≤3.3). At week 106, the 1-year sustained discontinuation rate was not significantly different between two groups; the programmed group 23.5% (40/170) and the standard group 21.6% (36/167), respectively (2.2% difference, 95% CI -6.6% to 11.0%; p=0.631). Baseline SDAI <26.0 was a statistically significant predictor of the successfully sustained discontinuation of IFX at week 106.
CONCLUSION


Programmed treatment strategy did not statistically increase the sustained remission rate after 1 year discontinuation of IFX treatment.",2020,"At week 106, the 1-year sustained discontinuation rate was not significantly different between two groups; the programmed group 23.5% (40/170) and the standard group 21.6% (36/167), respectively (2.2% difference, 95% CI -6.6% to 11.0%; p=0.631).","['patients with IFX-naïve rheumatoid arthritis with inadequate response to', 'patients with rheumatoid arthritis', '337 patients were randomised', 'Patients who achieved a simplified disease activity index (SDAI) ≤3.3 at week 54 discontinued IFX']","['3\u2009mg/kg IFX', 'standard treatment group received 3\u2009mg/kg of IFX', 'methotrexate', 'infliximab', 'infliximab (IFX']","['proportion of patients who sustained discontinuation of IFX', 'sustained remission rate', 'Baseline SDAI', '1-year sustained discontinuation rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}]","[{'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",337.0,0.12991,"At week 106, the 1-year sustained discontinuation rate was not significantly different between two groups; the programmed group 23.5% (40/170) and the standard group 21.6% (36/167), respectively (2.2% difference, 95% CI -6.6% to 11.0%; p=0.631).","[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of the First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Oba', 'Affiliation': 'Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Koike', 'Affiliation': 'Department of Clinical Immunology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Miyasaka', 'Affiliation': 'Department of Rheumatology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Tsuneyo', 'Initials': 'T', 'LastName': 'Mimori', 'Affiliation': 'Department of Rheumatology, Ijinkai Takeda General Hospital, Kyoto, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Rheumatology, Keio University, School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Hirata', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Tanaka', 'Affiliation': ""Department of Rheumatology, School of Medicine, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hidekata', 'Initials': 'H', 'LastName': 'Yasuoka', 'Affiliation': 'Department of Rheumatology, Keio University, School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Department of Rheumatology, Keio University, School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kosaku', 'Initials': 'K', 'LastName': 'Murakami', 'Affiliation': 'Deapartment of Rheumatology and Clinical Immunology, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Koga', 'Affiliation': 'Department of Immunology and Rheumatology, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Nakano', 'Affiliation': 'Department of the First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Amano', 'Affiliation': 'Department of Rheumatology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Kazuyasu', 'Initials': 'K', 'LastName': 'Ushio', 'Affiliation': 'Ushio Clinic, Osaka, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Clinical Immunology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Inoo', 'Affiliation': 'Utazu Hama Clinic, Ayauta-gun, Kagawa, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Hatta', 'Affiliation': 'Department of General Medicine, Tenri Hospital, Tenri, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Mizuki', 'Affiliation': 'The Centre for Rheumatic Diseases, Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Shouhei', 'Initials': 'S', 'LastName': 'Nagaoka', 'Affiliation': 'Department of Rheumatology, Yokohama Minami Kyosai Hospital, Yokohama, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Tsunoda', 'Affiliation': 'Division of Rheumatology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Dobashi', 'Affiliation': 'Division of Hematology, Rheumatology and Respiratory Medicine, Faculty of Medicine, Kagawa University, Miki, Japan.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Horie', 'Affiliation': 'Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, Hokkaido, Japan.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216169']
16,32389349,Effects of a projector-based hybrid virtual reality on pain in young children with burn injuries during hydrotherapy sessions: A within-subject randomized crossover trial.,"AIM


The aim of this study was to examine the effect of a water-friendly Projector-Based Hybrid Virtual Reality (VR) dome environment combined with standard pharmacological treatment on pain in young children undergoing burn wound care in hydrotherapy.
METHODS


This study was a prospective, within-subject crossover trial of 38 children aged 6 months to 7 years old (mean age=1.8 years old). Each hydrotherapy procedure was divided into two equivalent wound care segments (No hybrid VR during one segment vs. Hybrid VR during the other segment, treatment order was randomized). Pain was measured using the 0-10 FLACC (Face, Legs, Activity, Cry Consolability scale) and the 0-10 NRS-obs (Numerical Rating Scale-obs).
RESULTS


Projector-Based Hybrid VR significantly reduced procedural pain levels measured by the FLACC (p=0.026) and significantly increased patients' comfort levels (p=0.002). Patients' pain levels rated by the nurses using the NRS-obs were non-significant between both groups (p=0.135). No side effects were reported.
CONCLUSION


Projector-Based Hybrid VR helped in reducing the pain related to hydrotherapy procedures in young children with burn wound injuries. This is the first study using virtual reality distraction with young children, and our findings are especially important because a large percentage of pediatric burn patients are very young. Additional research and development are recommended.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02986464, registered on June 12, 2016.",2020,"RESULTS


Projector-Based Hybrid VR significantly reduced procedural pain levels measured by the FLACC (p=0.026) and significantly increased patients' comfort levels (p=0.002).","['young children', 'young children undergoing burn wound care in hydrotherapy', 'young children with burn injuries during hydrotherapy sessions', 'young children with burn wound injuries', '38 children aged 6 months to 7 years old (mean age=1.8 years old']","['virtual reality distraction', 'projector-based hybrid virtual reality', 'water-friendly Projector-Based Hybrid Virtual Reality (VR) dome environment combined with standard pharmacological treatment', 'Projector-Based Hybrid VR']","[""patients' comfort levels"", 'Pain', 'procedural pain levels', 'pain']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C3856907', 'cui_str': 'Projector'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0444914', 'cui_str': 'Domed'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",38.0,0.0313682,"RESULTS


Projector-Based Hybrid VR significantly reduced procedural pain levels measured by the FLACC (p=0.026) and significantly increased patients' comfort levels (p=0.002).","[{'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Khadra', 'Affiliation': 'Faculty of Nursing, University of Montreal: 2375, Chemin de la Côte-Ste-Catherine, Montreal (Quebec) H3T 1A8, Canada; CHU Sainte-Justine Research Center: 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada. Electronic address: christelle.khadra@umontreal.ca.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Ballard', 'Affiliation': 'Faculty of Nursing, University of Montreal: 2375, Chemin de la Côte-Ste-Catherine, Montreal (Quebec) H3T 1A8, Canada; CHU Sainte-Justine Research Center: 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada. Electronic address: ariane.ballard@umontreal.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paquin', 'Affiliation': ""Department in Creation and New Media, Université du Québec en Abitibi-Témiscamingue, Campus Rouyn-Noranda: 445, boul. de l'Université, Rouyn-Noranda (Quebec) J9X 5E4, Canada. Electronic address: david.Paquin@uqat.ca.""}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Cotes-Turpin', 'Affiliation': ""Department in Creation and New Media, Université du Québec en Abitibi-Témiscamingue, Campus Rouyn-Noranda: 445, boul. de l'Université, Rouyn-Noranda (Quebec) J9X 5E4, Canada. Electronic address: casey.cotes-turpin@uqat.ca.""}, {'ForeName': 'Hunter G', 'Initials': 'HG', 'LastName': 'Hoffman', 'Affiliation': 'Department of Mechanical Engineering, University of Washington: 3900 E Stevens Way NE, Seattle WA 98195, USA. Electronic address: hunthoff9@gmail.com.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Perreault', 'Affiliation': 'Department of Surgery, CHU Sainte-Justine: 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada. Electronic address: isabelperreault2@gmail.com.'}, {'ForeName': 'Jean-Simon', 'Initials': 'JS', 'LastName': 'Fortin', 'Affiliation': 'Emergency Department, Hôpital de Granby: 205 Boulevard Leclerc O, Granby (Quebec) J2G 1T7, Canada. Electronic address: js.fo@icloud.com.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bouchard', 'Affiliation': 'Department of Psychoeducation and Psychology, Université du Québec en Outaouais, 283, boulevard Alexandre-Taché, Gatineau (Quebec) J9A 1L8, Canada. Electronic address: stephane.bouchard@uqo.ca.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Théroux', 'Affiliation': 'School of Health Professions, Murdoch University: 90 South Street, Murdoch Western Australia 6150, Australia. Electronic address: jean.Theroux@murdoch.edu.au.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Le May', 'Affiliation': 'Faculty of Nursing, University of Montreal: 2375, Chemin de la Côte-Ste-Catherine, Montreal (Quebec) H3T 1A8, Canada; CHU Sainte-Justine Research Center: 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada. Electronic address: sylvie.lemay@umontreal.ca.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.04.006']
17,32335860,Effect of Tongguan Capsules () on Restenosis after Coronary Stent Implantation: Study Protocol for A Randomized Controlled Trial.,"BACKGROUND


Although percutaneous coronary intervention (PCI) had become widely employed therapeutic procedure for coronary artery disease, stent restenosis limited the benefits of this revascularization and the question how to prevent such events remained unresolved. While numerous empirical observations suggested Tongguan Capsules (), a patented Chinese Medicine, could decrease frequency and duration of angina pectoris attacks, evidence supporting its efficacy on restenosis remained inadequate.
OBJECTIVE


This trial was designed to determine whether Tongguan Capsules would reduce restenosis rate in patients after successful stent implantation.
METHODS


Approximately 400 patients undergoing percutaneous coronary stent deployment were enrolled and randomized to control group or Tongguan Capsules (4.5 g/d) for 3 months. All patients received standard anti-platelet, anti-coagulation and lipid-decreasing treatments, concurrently. The primary clinical endpoint was the 12-month incidence of the major adverse cardiovascular events (defined as cardiac death, myocardial infarction, and recurrence of symptoms requiring additional revascularization). The angiographic end point was restenosis rate at 6 months.
CONCLUSION


This study would provide important evidence for the use of Tongguan Capsules in patients after stent implantation in combination with routine therapies, which may significantly reduce incidence of the restenosis so as to potentially improve the clinical outcomes. (registration number: ChiCTR-TRC- ChiCTR-IIR-17011407).",2021,"While numerous empirical observations suggested Tongguan Capsules (), a patented Chinese Medicine, could decrease frequency and duration of angina pectoris attacks, evidence supporting its efficacy on restenosis remained inadequate.
","['patients after successful stent implantation', 'after Coronary Stent Implantation', 'Approximately 400 patients undergoing percutaneous coronary stent deployment']","['control group or Tongguan Capsules', 'standard anti-platelet, anti-coagulation and lipid-decreasing treatments, concurrently', 'Tongguan Capsules ', 'percutaneous coronary intervention (PCI']","['restenosis rate', '12-month incidence of the major adverse cardiovascular events (defined as cardiac death, myocardial infarction, and recurrence of symptoms requiring additional revascularization', 'frequency and duration of angina pectoris attacks', 'Restenosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2605709', 'cui_str': 'tongguan'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0852983', 'cui_str': 'Decreased lipid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",400.0,0.208738,"While numerous empirical observations suggested Tongguan Capsules (), a patented Chinese Medicine, could decrease frequency and duration of angina pectoris attacks, evidence supporting its efficacy on restenosis remained inadequate.
","[{'ForeName': 'Yuan-Shen', 'Initials': 'YS', 'LastName': 'Zhou', 'Affiliation': 'Key Discipline of Integrated Traditional Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Key Discipline of Integrated Traditional Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.'}, {'ForeName': 'Li-Heng', 'Initials': 'LH', 'LastName': 'Guo', 'Affiliation': 'Key Discipline of Integrated Traditional Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.'}, {'ForeName': 'Xiong-Yi', 'Initials': 'XY', 'LastName': 'Gao', 'Affiliation': 'Key Discipline of Integrated Traditional Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Key Discipline of Integrated Traditional Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.'}, {'ForeName': 'Min-Zhou', 'Initials': 'MZ', 'LastName': 'Zhang', 'Affiliation': 'Key Discipline of Integrated Traditional Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. minzhouzhang@aliyun.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-2722-6']
18,32209449,"Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study.","BACKGROUND


Conventional imaging using CT and bone scan has insufficient sensitivity when staging men with high-risk localised prostate cancer. We aimed to investigate whether novel imaging using prostate-specific membrane antigen (PSMA) PET-CT might improve accuracy and affect management.
METHODS


In this multicentre, two-arm, randomised study, we recruited men with biopsy-proven prostate cancer and high-risk features at ten hospitals in Australia. Patients were randomly assigned to conventional imaging with CT and bone scanning or gallium-68 PSMA-11 PET-CT. First-line imaging was done within 21 days following randomisation. Patients crossed over unless three or more distant metastases were identified. The primary outcome was accuracy of first-line imaging for identifying either pelvic nodal or distant-metastatic disease defined by the receiver-operating curve using a predefined reference-standard including histopathology, imaging, and biochemistry at 6-month follow-up. This trial is registered with the Australian New Zealand Clinical Trials Registry, ANZCTR12617000005358.
FINDINGS


From March 22, 2017 to Nov 02, 2018, 339 men were assessed for eligibility and 302 men were randomly assigned. 152 (50%) men were randomly assigned to conventional imaging and 150 (50%) to PSMA PET-CT. Of 295 (98%) men with follow-up, 87 (30%) had pelvic nodal or distant metastatic disease. PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p<0·0001). We found a lower sensitivity (38% [24-52] vs 85% [74-96]) and specificity (91% [85-97] vs 98% [95-100]) for conventional imaging compared with PSMA PET-CT. Subgroup analyses also showed the superiority of PSMA PET-CT (area under the curve of the receiver operating characteristic curve 91% vs 59% [32% absolute difference; 28-35] for patients with pelvic nodal metastases, and 95% vs 74% [22% absolute difference; 18-26] for patients with distant metastases). First-line conventional imaging conferred management change less frequently (23 [15%] men [10-22] vs 41 [28%] men [21-36]; p=0·008) and had more equivocal findings (23% [17-31] vs 7% [4-13]) than PSMA PET-CT did. Radiation exposure was 10·9 mSv (95% CI 9·8-12·0) higher for conventional imaging than for PSMA PET-CT (19·2 mSv vs 8·4 mSv; p<0·001). We found high reporter agreement for PSMA PET-CT (κ=0·87 for nodal and κ=0·88 for distant metastases). In patients who underwent second-line image, management change occurred in seven (5%) of 136 patients following conventional imaging, and in 39 (27%) of 146 following PSMA PET-CT.
INTERPRETATION


PSMA PET-CT is a suitable replacement for conventional imaging, providing superior accuracy, to the combined findings of CT and bone scanning.
FUNDING


Movember and Prostate Cancer Foundation of Australia. VIDEO ABSTRACT.",2020,PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p<0·0001).,"['patients with high-risk prostate cancer before curative-intent surgery or', 'staging men with high-risk localised prostate cancer', 'Of 295 (98%) men with follow-up, 87 (30%) had pelvic nodal or distant metastatic disease', 'From March 22, 2017 to Nov 02, 2018, 339 men were assessed for eligibility and 302 men', 'recruited men with biopsy-proven prostate cancer and high-risk features at ten hospitals in Australia', '152 (50%) men']","['novel imaging using prostate-specific membrane antigen (PSMA', 'Prostate-specific membrane antigen PET-CT', 'PSMA PET-CT', 'radiotherapy (proPSMA', 'PET-CT', 'conventional imaging with CT and bone scanning or gallium-68 PSMA-11 PET-CT', 'CT and bone scan']","['accuracy of first-line imaging for identifying either pelvic nodal or distant-metastatic disease defined by the receiver-operating curve using a predefined reference-standard including histopathology, imaging, and biochemistry', 'superiority of PSMA PET-CT', 'lower sensitivity', 'specificity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1310550', 'cui_str': 'prostate-specific membrane antigen, human'}, {'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0303226', 'cui_str': 'Gallium-68'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0034925', 'cui_str': 'Reference Standards'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677043', 'cui_str': 'Histopathology (qualifier value)'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",339.0,0.223657,PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p<0·0001).,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Hofman', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. Electronic address: michael.hofman@petermac.org.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Lawrentschuk', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Department of Surgery, Austin Health, Melbourne, VIC, Australia; Urological Society of Australia and New Zealand, NSW, Australia.'}, {'ForeName': 'Roslyn J', 'Initials': 'RJ', 'LastName': 'Francis', 'Affiliation': 'Department of Nuclear Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia; University of Western Australia, Faculty of Health and Medical Sciences, Perth, WA, Australia; ARTnet, NSW, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Vela', 'Affiliation': 'Department of Urology, Princess Alexandra Hospital, Australian Prostate Cancer Research Centre-Queensland, Queensland University of Technology, Translational Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': ""Department of Nuclear Medicine, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia; Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rutherford', 'Affiliation': 'Department of Nuclear Medicine, Hunter New England Health, Newcastle, NSW, Australia.'}, {'ForeName': 'Jarad M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Frydenberg', 'Affiliation': 'Department of Surgery, Monash University and Cabrini Institute, Cabrini Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Ramdave', 'Initials': 'R', 'LastName': 'Shakher', 'Affiliation': 'Monash Health Imaging, Monash Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Lih-Ming', 'Initials': 'LM', 'LastName': 'Wong', 'Affiliation': ""Department of Urology and Surgery, St Vincent's Health Melbourne, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Taubman', 'Affiliation': ""Department of Medical Imaging, PET/CT and St Vincent's Private Radiology, St Vincent's Health, Melbourne, VIC, Australia.""}, {'ForeName': 'Sze', 'Initials': 'S', 'LastName': 'Ting Lee', 'Affiliation': 'Department of Molecular Imaging and Therapy, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Hsiao', 'Affiliation': 'University of Sydney, Department of Nuclear Medicine and PET, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Roach', 'Affiliation': 'University of Sydney, Department of Nuclear Medicine and PET, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Nottage', 'Affiliation': 'Clinical and Research Imaging Centre, South Australian Health and Medical Research Institute, Adelaide, SA, Australia; Dr Jones and Partners Medical Imaging, Adelaide, SA, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kirkwood', 'Affiliation': 'Department of Nuclear Medicine and PET, Royal Adelaide Hospital, Adelaide, SA, Australia; Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Dickon', 'Initials': 'D', 'LastName': 'Hayne', 'Affiliation': 'UWA Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Link', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Marusic', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Anetta', 'Initials': 'A', 'LastName': 'Matera', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Iravani', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Rodney J', 'Initials': 'RJ', 'LastName': 'Hicks', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Australian and New Zealand Urogenital and Prostate Cancer Trials Group, NSW, Australia.'}, {'ForeName': 'Declan G', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': 'Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30314-7']
19,29332989,Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial.,"This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans ( N  = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual art therapy. PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups. Art therapy in conjunction with CPT was found to improve trauma processing and veterans considered it to be an important part of their treatment as it provided healthy distancing, enhanced trauma recall, and increased access to emotions.",2016,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"['Veterans ( N  = 11', 'Combat-Related PTSD']","['Cognitive Processing Therapy (CPT', 'individual CPT, or individual CPT in conjunction with individual art therapy', 'Art Therapy and Cognitive Processing Therapy']",['PTSD Checklist-Military Version and Beck Depression Inventory-II scores'],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0003827', 'cui_str': 'Art Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4273555', 'cui_str': 'BDI-II (Beck Depression Inventory Second Edition) score'}]",11.0,0.0332411,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Art therapist at the University Neuro-psychiatric Institute, University of Utah, Salt Lake City.'}, {'ForeName': 'Kathleen P', 'Initials': 'KP', 'LastName': 'Decker', 'Affiliation': 'Staff psychiatrist at the Hampton VA Medical Center, Hampton, VA, and faculty member in the Department of Psychiatry at Eastern Virginia Medical School, Norfolk.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Kruk', 'Affiliation': 'Community faculty.'}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Deaver', 'Affiliation': 'Professor in the Graduate Art Therapy and Counseling Professions Program, Eastern Virginia Medical School.'}]",Art therapy : journal of the American Art Therapy Association,['10.1080/07421656.2016.1226643']
20,32309918,Novel cardiovascular biomarkers in patients with cardiovascular diseases undergoing intensive physical exercise.,"BACKGROUND


In this trial, we analyzed the plasma levels of novel biomarkers that reflect different pathophysiological pathways (sST2: mechanical strain, IGF-BP2: metabolic pathways, suPAR and GDF-15: inflammatory processes) in patients undergoing physical exercise to investigate the effects of training on their plasma concentrations.
METHODS


Plasma concentrations of novel biomarkers (sST2, IGF-BP2, suPAR and GDF-15) were analyzed by means of ELISA in patients with stable coronary artery disease (CAD) undergoing four weeks of high- and moderate-intensity training (EXCITE Trial) and in patients with one or more cardiovascular risk factors undergoing eight months of intensive physical exercise (IGF-BP2). Plasma levels of sST2 in patients undergoing eight months of intensive exercise have been published previously by our study group (1.13-fold change, P=0.045).
RESULTS


Four weeks of high-intensity exercise training resulted in a statistically significant change in the plasma level of sST2 (1.106-fold change, P=0.0054) and IGF-BP2 (1.24-fold-change, P=0.0165). Eight months of intensive exercise resulted in a significant increase of IGF-BP2 (median 61.2 ng/mL to 80.7 ng/mL, 1.319-fold change, P=0.006).
CONCLUSIONS


The significant increase of sST2 after four weeks might be a short-term effect due to the mechanical strain caused by the high-intensity training program, whereas the increase in IGF-BP2 after four weeks and eight months is likely a result of metabolic changes due to physical exercise.",2020,"Eight months of intensive exercise resulted in a significant increase of IGF- BP2 (median 61.2 ng/mL to 80.7 ng/mL, 1.319-fold change, p= 0.006).
","['patients undergoing', 'patients with cardiovascular diseases undergoing intensive physical exercise', 'patients undergoing eight months of', 'patients with stable coronary artery disease (CAD) undergoing four weeks of high- and moderate-intensity training (EXCITE trial) and in patients with one or more cardiovascular risk factors undergoing eight months of']","['intensive physical exercise (IGF-BP2', 'physical exercise', 'intensive exercise', 'high-intensity exercise training']","['Plasma levels of sST2', 'plasma level of sST2', 'novel biomarkers (sST2, IGF-BP2, suPAR and GDF-15', 'IGF-BP2', 'sST2', 'IGF- BP2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}]",,0.0334396,"Eight months of intensive exercise resulted in a significant increase of IGF- BP2 (median 61.2 ng/mL to 80.7 ng/mL, 1.319-fold change, p= 0.006).
","[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Mirna', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, Paracelsus Medical University of Salzburg, Salzburg, Austria - m.mirna@salk.at.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lichtenauer', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, Paracelsus Medical University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Wernly', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, Paracelsus Medical University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Paar', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, Paracelsus Medical University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': 'Division of Cardiology, Pulmonology, and Vascular Medicine, Faculty of Medicine, Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kretzschmar', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine I, Friedrich Schiller University, Jena, Germany.'}, {'ForeName': 'Madlen', 'Initials': 'M', 'LastName': 'Uhlemann', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Franz', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine I, Friedrich Schiller University, Jena, Germany.'}, {'ForeName': 'Uta C', 'Initials': 'UC', 'LastName': 'Hoppe', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, Paracelsus Medical University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'P Christian', 'Initials': 'PC', 'LastName': 'Schulze', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine I, Friedrich Schiller University, Jena, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hilberg', 'Affiliation': 'Faculty II/Sports Science, Sports Medicine, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Adams', 'Affiliation': 'Department of Internal Medicine and Cardiology, Heart Center Dresden, Technical University, Dresden, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sponder', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Möbius-Winkler', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine I, Friedrich Schiller University, Jena, Germany.'}]",Panminerva medica,['10.23736/S0031-0808.20.03838-0']
21,32303413,Differences and Effects of Metabolic Fate of Individual Amino Acid Loss in High-Efficiency Hemodialysis and Hemodiafiltration.,"OBJECTIVE


The objective of the study was to quantify the loss and arterial blood concentration of the three main classes of amino acids (AAs)-nonessential amino acids (NEAAs), essential amino acids (EAAs), and branched-chain amino acids-as resulting from high-efficiency hemodialysis (HED) and hemodiafiltration (HDF). We moreover aimed to identify the different fates and metabolic effects manifested in patients undergoing hemodialysis and the consequences on body composition and influence of nutritional decline into protein energy wasting.
DESIGN AND METHODS


Identical dialysis monitors, membranes, and dialysate/infusate were used to ensure consistency. Ten patients were recruited and randomized to receive treatment with on-line modern HED and HDF. Arterial plasma concentrations of individual AAs were compared in healthy volunteers and patients undergoing hemodialysis, and AA levels outflowing from the dialyzer were evaluated. Baseline AA plasma levels of patients undergoing hemodialysis were compared with findings obtained 1 year later.
RESULTS


A severe loss of AA with HED/HDF was confirmed: a marked loss of total AAs (5 g/session) was detected, corresponding to more than 65% of all AAs. With regard to individual AAs, glutamine displayed a consistent increase (+150%), whereas all other AAs decreased after 12 months of HD/HDF. Only a few AAs, such as proline, cysteine, and histidine maintained normal levels. The most severe metabolic consequences may result from losses of EAAs such as valine, leucine, and histidine and from NEAAs including proline, cysteine, and glutamic acid eliciting the onset of hypercatabolism threatening muscle mass loss.
CONCLUSION


Dialysis losses, together with the effect of chronic uremia, resulted in a reduction of fundamental EAAs and NEAAs, which progressively led our patients after 12 months to a deterioration of lean mass toward sarcopenia. Therefore, the reintroduction of a correctly balanced AA supplementation in patients undergoing HD to prevent or halt decline of hypercatabolism into cachexia is recommended.",2020,"With regard to individual AAs, glutamine displayed a consistent increase (+150%), whereas all other AAs decreased after 12 months of HD/HDF.","['healthy volunteers and patients undergoing hemodialysis, and AA levels outflowing from the dialyzer were evaluated', 'patients undergoing hemodialysis', 'patients undergoing HD', 'High-Efficiency Hemodialysis and Hemodiafiltration']",[],"['marked loss of total AAs', 'Baseline AA plasma levels', 'Arterial plasma concentrations of individual AAs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",10.0,0.0342849,"With regard to individual AAs, glutamine displayed a consistent increase (+150%), whereas all other AAs decreased after 12 months of HD/HDF.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Murtas', 'Affiliation': 'Territorial Department of Nephrology and Dialysis, ASSL Cagliari, Cagliari, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Aquilani', 'Affiliation': 'Department of Biology and Biotechnology, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Iadarola', 'Affiliation': 'Department of Biology and Biotechnology, University of Pavia, Pavia, Italy.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Deiana', 'Affiliation': 'Territorial Department of Nephrology and Dialysis, ASSL Cagliari, Cagliari, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Secci', 'Affiliation': 'Territorial Department of Nephrology and Dialysis, ASSL Cagliari, Cagliari, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cadeddu', 'Affiliation': 'Territorial Department of Nephrology and Dialysis, ASSL Cagliari, Cagliari, Italy.'}, {'ForeName': 'Piergiorgio', 'Initials': 'P', 'LastName': 'Bolasco', 'Affiliation': 'Treatment Study Group of Chronic Renal Disease of Italian Society of Nephrology, Cagliari, Italy. Electronic address: pg.bolasco@gmail.com.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2019.12.003']
22,32281466,A proof-of-concept study comparing tinnitus and neural connectivity changes following multisensory perceptual training with and without a low-dose of fluoxetine.,"Background.  This proof-of-concept study investigated a method of multisensory perceptual training for tinnitus, and whether a short, low-dose administration of fluoxetine enhanced training effects and changed neural connectivity. Methods.  A double-blind, randomized placebo controlled design with 20 participants (17 male, 3 female, mean age = 57.1 years) involved 30 min daily computer-based, multisensory training (matching visual, auditory and tactile stimuli to perception of tinnitus) for 20 days, and random allocation to take 20 mg fluoxetine or placebo daily. Behavioral measures of tinnitus and correlations between pairs of a priori regions of interest (ROIs), obtained using resting-state functional magnetic resonance imaging (rs-fMRI), were performed before and after the training. Results.  Significant changes in ratings of tinnitus loudness, annoyance, and problem were observed with training. No statistically significant changes in Tinnitus Functional Index, Tinnitus Handicap Inventory or Depression Anxiety Stress Scales were found with training. Fluoxetine did not alter any of the behavioural outcomes of training compared to placebo. Significant changes in connectivity between ROIs were identified with training; sensory and attention neural network ROI changes correlated with significant tinnitus rating changes. Rs-fMRI results suggested that the direction of functional connectivity changes between auditory and non-auditory networks, with training and fluoxetine, were opposite to the direction of those changes with multisensory training and placebo. Conclusions.  Improvements in tinnitus measures were correlated with changes in sensory and attention networks. The results provide preliminary evidence for changes in rs-fMRI accompanying a multisensory training method in persons with tinnitus.",2021,"No statistically significant changes in Tinnitus Functional Index, Tinnitus Handicap Inventory or Depression Anxiety Stress Scales were found with training.","['20 participants (17 male, 3 female, mean age = 57.1 years) involved', 'persons with tinnitus']","['multisensory perceptual training', 'fluoxetine', '30\u2009min daily computer-based, multisensory training (matching visual, auditory and tactile stimuli to perception of tinnitus', 'placebo', 'Fluoxetine', 'multisensory training and placebo', 'fluoxetine or placebo daily']","['ratings of tinnitus loudness, annoyance, and problem', 'behavioural outcomes', 'Tinnitus Functional Index, Tinnitus Handicap Inventory or Depression Anxiety Stress Scales', 'sensory and attention networks']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]","[{'cui': 'C0556503', 'cui_str': 'Perceptual training'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",,0.0962437,"No statistically significant changes in Tinnitus Functional Index, Tinnitus Handicap Inventory or Depression Anxiety Stress Scales were found with training.","[{'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Searchfield', 'Affiliation': 'Eisdell Moore Centre & Audiology Section, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Spiegel', 'Affiliation': 'Essilor Research and Development, Singapore, Singapore.'}, {'ForeName': 'T N E R', 'Initials': 'TNER', 'LastName': 'Poppe', 'Affiliation': 'Biomedical Engineering and Imaging Sciences, Kings College London, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Durai', 'Affiliation': 'Eisdell Moore Centre & Audiology Section, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jensen', 'Affiliation': 'Bay of Plenty and School of Pharmacy, Pharmacy, Whakatane Hospital, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Eisdell Moore Centre & Audiology Section, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Eisdell Moore Centre & Audiology Section, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Russell', 'Affiliation': 'School of Pharmacy, Otago University, Dunedin, New Zealand.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Shekhawat', 'Affiliation': 'The Ear Institute, University College, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sundram', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'B B', 'Initials': 'BB', 'LastName': 'Thompson', 'Affiliation': 'School of Optometry and Vision Science, University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Wise', 'Affiliation': 'Eisdell Moore Centre & Speech Science, The University of Auckland, Auckland, New Zealand.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1746310']
23,31332027,Circulating Gut Microbiota Metabolite Trimethylamine N-Oxide (TMAO) and Changes in Bone Density in Response to Weight Loss Diets: The POUNDS Lost Trial.,"OBJECTIVE


Type 2 diabetes is related to obesity and altered bone health, and both are affected by gut microbiota. We examined associations of weight loss diet-induced changes in a gut microbiota-related metabolite trimethylamine N-oxide (TMAO), and its precursors (choline and l-carnitine), with changes in bone mineral density (BMD) considering diabetes-related factors.
RESEARCH DESIGN AND METHODS


In the 2-year Preventing Overweight Using Novel Dietary Strategies trial (POUNDS Lost), 264 overweight and obese participants with measurement of BMD by DXA scan were included in the present analysis. The participants were randomly assigned to one of four diets varying in macronutrient intake. Association analysis was performed in pooled participants and different diet groups. Changes in blood levels of TMAO, choline, and l-carnitine from baseline to 6 months after the dietary intervention were calculated.
RESULTS


We found that a greater reduction in plasma levels of TMAO from baseline to 6 months was associated with a greater loss in whole-body BMD at 6 months and 2 years ( P  = 0.03 and  P  = 0.02). The greater reduction in TMAO was also associated with a greater loss in spine BMD ( P  = 0.005) at 2 years, independent of body weight changes. The associations were not modified by baseline diabetes status and glycemic levels. Changes in l-carnitine, a precursor of TMAO, showed interactions with dietary fat intake in regard to changes of spine BMD and hip BMD at 6 months (all  P  < 0.05). Participants with the smallest decrease in l-carnitine showed less bone loss in the low-fat diet group than the high-fat diet group ( P   spine  = 0.03 and  P   hip  = 0.02).
CONCLUSIONS


TMAO might protect against BMD reduction during weight loss, independent of diet interventions varying in macronutrient content and baseline diabetes risk factors. Dietary fat may modify the relation between change in plasma l-carnitine level and changes in BMD. Our findings highlight the importance of investigating the relation between TMAO and bone health in patients with diabetes.",2019,"The greater reduction in TMAO was also associated with a greater loss in spine BMD ( P  = 0.005) at 2 years, independent of body weight changes.","['264 overweight and obese participants with measurement of BMD by DXA scan', 'patients with diabetes']","['TMAO', 'four diets varying in macronutrient intake']","['spine BMD', 'Circulating Gut Microbiota Metabolite Trimethylamine N-Oxide (TMAO', 'TMAO', 'blood levels of TMAO, choline, and l-carnitine', 'plasma levels of TMAO', 'plasma l-carnitine level and changes in BMD', 'l-carnitine', 'bone loss', 'spine BMD and hip BMD']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1959592', 'cui_str': 'DEXA Scan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}]","[{'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]",264.0,0.0222115,"The greater reduction in TMAO was also associated with a greater loss in spine BMD ( P  = 0.005) at 2 years, independent of body weight changes.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Dianjianyi', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'DiDonato', 'Affiliation': 'Department of Cardiovascular & Metabolic Sciences, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Pei', 'Affiliation': 'Department of Public Health Laboratory Sciences, West China School of Public Health, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Meryl S', 'Initials': 'MS', 'LastName': 'LeBoff', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA lqi1@tulane.edu.'}]",Diabetes care,['10.2337/dc19-0134']
24,32216594,The effect of acidic beverage versus mineral water on the change in serum phenobarbital concentrations: a randomized clinical trial on children with seizure.,"OBJECTIVE


To assess the effect of an acidic beverage (Orange juice) on the change in serum Phenobarbital concentrations in children with seizure who take Phenobarbital as the main treatment.
METHODS


We did a parallel design and placebo controlled randomized clinical trial. Patients attending Heshmatiyeh Hospital (Iran) were recruited from October 2016 to December 2017. Forty patients randomly assigned to either experimental group or control group. Firstly, 5 mL blood sample was taken from both groups to measure serum Phenobarbital concentration before experiment. Then, one oral dose of Phenobarbital (2.5 mg/kg) with 100 mL of corporate Orange juice (pH = 3.5) (experiment group) or 100 mL of mineral water (neutral pH) (control group) was given to each group, respectively. After 2 h of administration, another blood sample was taken. The high-performance liquid chromatographic system was used for measurement of serum Phenobarbital concentration.
RESULTS


There was significant increase in serum Phenobarbital concentrations after taking Phenobarbital in experiment group in comparison to control group. Statistical analysis revealed a significant increase in change of serum Phenobarbital concentrations in experiment group versus control group.
CONCLUSION


The results of the current trial indicate that the level of serum Phenobarbital in the experiment group was higher than that of control group.",2021,Statistical analysis revealed a significant increase in change of serum Phenobarbital concentrations in experiment group versus control group.,"['children with seizure', 'children with seizure who take Phenobarbital as the main treatment', 'Patients attending Heshmatiyeh Hospital (Iran) were recruited from October 2016 to December 2017']","['acidic beverage versus mineral water', 'acidic beverage (Orange juice', 'placebo', 'Phenobarbital (2.5\u2009mg/kg) with 100\u2009ml of corporate Orange juice (pH =3.5) (experiment group) or 100\u2009ml of mineral water (neutral pH) (control group']","['change of serum Phenobarbital concentrations', 'serum Phenobarbital concentration', 'serum Phenobarbital concentrations', 'level of serum Phenobarbital']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0026157', 'cui_str': 'Mineral Waters'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",40.0,0.0353977,Statistical analysis revealed a significant increase in change of serum Phenobarbital concentrations in experiment group versus control group.,"[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Tavasolizadeh', 'Affiliation': 'Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Hasanpour', 'Affiliation': 'Department of Pediatrics, Heshmatiyeh Hospital, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Nazarzadeh', 'Affiliation': 'The George Institute for Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Mahdian', 'Affiliation': 'Cellular and Molecular Research Center, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Gholami', 'Affiliation': 'Cellular and Molecular Research Center, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1748619']
25,32293830,"Trauma, treatment and Tetris: video gaming increases hippocampal volume in male patients with combat-related posttraumatic stress disorder.","Background


Tetris has been proposed as a preventative intervention to reduce intrusive memories of a traumatic event. However, no neuroimaging study has assessed Tetris in patients with existing posttraumatic stress disorder (PTSD) or explored how playing Tetris may affect brain structure.
Methods


We recruited patients with combat-related PTSD before psychotherapy and randomly assigned them to an experimental Tetris and therapy group (n = 20) or to a therapy-only control group (n = 20). In the control group, participants completed therapy as usual: eye movement desensitization and reprocessing (EMDR) psychotherapy. In the Tetris group, in addition to EMDR, participants also played 60 minutes of Tetris every day from onset to completion of therapy, approximately 6 weeks later. Participants completed structural MRI and psychological questionnaires before and after therapy, and we collected psychological questionnaire data at follow-up, approximately 6 months later. We hypothesized that the Tetris group would show increases in hippocampal volume and reductions in symptoms, both directly after completion of therapy and at follow-up.
Results


Following therapy, hippocampal volume increased in the Tetris group, but not the control group. As well, hippocampal increases were correlated with reductions in symptoms of PTSD, depression and anxiety between completion of therapy and follow-up in the Tetris group, but not the control group.
Limitations


Playing Tetris may act as a cognitive interference task and as a brain-training intervention, but it was not possible to distinguish between these 2 potential mechanisms.
Conclusion


Tetris may be useful as an adjunct therapeutic intervention for PTSD. Tetris-related increases in hippocampal volume may ensure that therapeutic gains are maintained after completion of therapy.",2020,"As well, hippocampal increases were correlated with reductions in symptoms of PTSD, depression and anxiety between completion of therapy and follow-up in the Tetris group, but not the control group.
","['male patients with combat-related posttraumatic stress disorder', 'patients with combat-related PTSD before psychotherapy and randomly assigned them to an experimental Tetris and therapy group (n = 20) or to a therapy-only control group (n = 20', 'patients with existing posttraumatic stress disorder (PTSD']","['usual: eye movement desensitization and reprocessing (EMDR) psychotherapy', 'Tetris: video gaming']","['collected psychological questionnaire data', 'structural MRI and psychological questionnaires', 'hippocampal volume', 'symptoms of PTSD, depression and anxiety']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0274997,"As well, hippocampal increases were correlated with reductions in symptoms of PTSD, depression and anxiety between completion of therapy and follow-up in the Tetris group, but not the control group.
","[{'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Butler', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Herr', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Willmund', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gallinat', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zimmermann', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.190027']
26,32223344,"Mindfulness-based cognitive therapy reduces clinical symptoms, but do not change frontal alpha asymmetry in people with major depression disorder.","OBJECTIVES


Mindfulness-based cognitive therapy (MBCT) has demonstrated to be successful in the reduction of relapse rates in patients with recurrent major depressive disorder (MDD). Little is known if MBCT is effective for treating individuals with current MDD episode and about underlying psychophysiological mechanisms of symptoms reduction. The aim of the present study was to assess effects of MBCT on depressed individuals in terms of reduction of depressive and anxiety symptoms and to evaluate if this therapeutic improvement would be reflected on neurophysiological level by shift in frontal alpha asymmetry (FAA).
PARTICIPANTS


We studied 20 individuals with current MDD.
DESIGN


Participants were randomly assigned either to waiting list or 8-week MBCT. Before and after the treatment we have assessed depression, anxiety, and FAA in resting-state electroencephalogram (EEG) - an indicator of approach vs. withdrawal-related response dispositions and a vulnerability factor of MDD.
RESULTS


In line with previous findings, reduction of depressive and anxiety symptoms, but no change in mean values of FAA in MBCT group was found.
CONCLUSIONS


These results provide a support for the beneficial effects of MBCT in current MDD treatment, however, they do not support the hypothesis on alpha asymmetry change as a neural correlate of MDD improvement.",2021,Mindfulness-based cognitive therapy (MBCT) has demonstrated to be successful in the reduction of relapse rates in patients with recurrent major depressive disorder (MDD).,"['20 individuals with current MDD', 'people with major depression disorder', 'patients with recurrent major depressive disorder (MDD']","['Mindfulness-based cognitive therapy (MBCT', 'waiting list or 8-week MBCT', 'Mindfulness-based cognitive therapy', 'MBCT']","['mean values of FAA', 'depression, anxiety, and FAA in resting-state electroencephalogram (EEG', 'reduction of depressive and anxiety symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes (disorder)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",20.0,0.0432478,Mindfulness-based cognitive therapy (MBCT) has demonstrated to be successful in the reduction of relapse rates in patients with recurrent major depressive disorder (MDD).,"[{'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Szumska', 'Affiliation': 'Clinical Neuroscience Lab, Institute of Psychology, Polish Academy of Sciences, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Gola', 'Affiliation': 'Clinical Neuroscience Lab, Institute of Psychology, Polish Academy of Sciences, Poland.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Rusanowska', 'Affiliation': 'Clinical Neuroscience Lab, Institute of Psychology, Polish Academy of Sciences, Poland.'}, {'ForeName': 'Martyna', 'Initials': 'M', 'LastName': 'Krajewska', 'Affiliation': 'Faculty of Physics, University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Żygierewicz', 'Affiliation': 'Faculty of Physics, University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Krejtz', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Nezlek', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Holas', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Warsaw, Poland.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1748621']
27,31959386,A randomised double-blind dose-response study of weight-adjusted infusions of norepinephrine for preventing hypotension during combined spinal-epidural anaesthesia for Caesarean delivery.,"BACKGROUND


Norepinephrine infusion has been suggested as an effective method for preventing hypotension during spinal anaesthesia for Caesarean delivery. However, optimal dosing regimens for norepinephrine have not been well established. This study aimed to determine the dose-response characteristics of a weight-adjusted fixed-rate infusion of norepinephrine to prevent hypotension during neuraxial anaesthesia for Caesarean delivery.
METHODS


In a double-blind, randomised controlled trial, 80 parturients having elective Caesarean delivery received a prophylactic norepinephrine infusion at 0.025 μg kg -1  min -1  (Group N1), 0.05 μg kg -1  min -1  (Group N2), 0.075 μg kg -1  min -1  (Group N3), or 0.10 μg kg -1  min -1  (Group N4), starting immediately after induction of combined spinal-epidural anaesthesia. The primary outcome was non-occurrence of hypotension, defined as a decrease in systolic arterial pressure ≥20% below baseline value or to ≤90 mm Hg, before delivery. Values for 50% effective dose (ED 50 ) and ED 90  were calculated using probit regression.
RESULTS


The incidence of hypotension was 11/20 (55%), 6/20 (30%), 2/20 (10%), and 1/20 (5%) in Groups N1, N2, N3, and N4, respectively (P<0.0001). The ED 50  and ED 90  (95% confidence interval) of norepinephrine infusions for preventing hypotension were 0.029 (-0.002 to 0.043) and 0.080 (0.065-0.116) μg kg -1  min -1 , respectively. The incidence of reactive hypertension increased with increasing norepinephrine dose (P=0.002). Other adverse effects were similar among groups.
CONCLUSIONS


Under the conditions of this study, an infusion of norepinephrine 0.08 μg kg -1  min -1  was effective for preventing hypotension in 90% of patients. This information should provide a guide for initiating norepinephrine infusions.
CLINICAL TRIAL REGISTRATION


ChiCTR1900022322 at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/enindex.aspx).",2020,The ED 50  and ED 90  (95% confidence interval) of norepinephrine infusions for preventing hypotension were 0.029,"['80 parturients having elective Caesarean delivery received a', 'hypotension during combined spinal-epidural anaesthesia for Caesarean delivery']","['norepinephrine', 'Norepinephrine infusion', 'prophylactic norepinephrine infusion']","['adverse effects', 'systolic arterial pressure', 'non-occurrence of hypotension', 'hypotension', 'incidence of hypotension', 'reactive hypertension']","[{'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}]","[{'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.569245,The ED 50  and ED 90  (95% confidence interval) of norepinephrine infusions for preventing hypotension were 0.029,"[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Wending', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Warwick D', 'Initials': 'WD', 'LastName': 'Ngan Kee', 'Affiliation': 'Department of Anesthesiology, Sidra Medicine, Doha, Qatar.'}, {'ForeName': 'Xinzhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China. Electronic address: chenxinz@zju.edu.cn.""}]",British journal of anaesthesia,['10.1016/j.bja.2019.12.019']
28,32185847,Feasibility and reliability of continuously monitoring alcohol use among female adolescents and young adults.,"INTRODUCTION AND AIMS


Transdermal alcohol sensors allow objective, continuous monitoring and have potential to expand current research on adolescent and young adult alcohol use. The purpose of this manuscript is to evaluate the feasibility and reliability of transdermal alcohol sensor use among female adolescents as compared to female young adults.
DESIGN AND METHODS


This trial included 59 female adolescents and young adults aged 14-24 years who reported drinking during the previous month. All participants were asked to wear a Giner Wrist Transdermal Alcohol Sensor (WrisTAS)-7 over a 1 month prospective study. Participants came to the research lab weekly to complete a detailed self-report of behaviours, including day of drinking events, amounts and types of alcohol use and length of drinking events. Estimates of blood alcohol concentration (eBAC) were computed from self-report data using the Matthew and Miller, NHTSA and Zhang equations. Daily transdermal alcohol concentration (TAC) peaks and calculated eBAC peak data were analysed with paired-samples t-tests and repeated measures correlations for validity comparisons.
RESULTS


All participants (100%, n = 59) completed the trial, however, two participants were removed due to greater than 50% of missing transdermal alcohol sensor data. Of the 57 participants, the data included 1,722 days of continuous alcohol monitoring. Missing data was recorded more frequently among female adolescents at about (11.78%) as compared to female young adults (8.59%; χ 2   = -18.40, P < 0.001). Participant self-report of drinking occurred with greater frequency (374 events) than detected by the WrisTAS transdermal alcohol sensors (243 events). On days when self-report and sensor data indicated a drinking event, participants' eBAC was moderately correlated with TAC, after accounting for repeated measures.
DISCUSSION AND CONCLUSIONS


This study finds that transdermal alcohol sensors are moderately reliable when sensor data is paired with self-report. This objective data collection method may improve the ability to collect alcohol curves among adolescents.",2021,"Missing data was recorded more frequently among female adolescents at about (11.78%) as compared to female young adults (8.59%; χ 2  = -18.40, P < 0.001).","['57 participants, the data included 1,722\u2009days of continuous alcohol monitoring', '59 female adolescents and young adults aged 14-24 years who reported drinking during the previous month', 'female young adults', 'adolescents', 'All participants (100%, n = 59) completed the trial, however, two participants were removed due to greater than 50% of missing transdermal alcohol sensor data', 'female adolescents', 'female adolescents and young adults']","['transdermal alcohol sensor', 'Giner Wrist Transdermal Alcohol Sensor']","['Daily transdermal alcohol concentration (TAC) peaks and calculated eBAC peak data', 'blood alcohol concentration (eBAC']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}]",59.0,0.0177481,"Missing data was recorded more frequently among female adolescents at about (11.78%) as compared to female young adults (8.59%; χ 2  = -18.40, P < 0.001).","[{'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Croff', 'Affiliation': 'National Center for Wellness and Recovery, Oklahoma State University Center for Health Sciences, Tulsa, USA.'}, {'ForeName': 'Micah L', 'Initials': 'ML', 'LastName': 'Hartwell', 'Affiliation': 'School of Community Health Sciences, Counseling and Counseling Psychology, Oklahoma State University, Tulsa, USA.'}, {'ForeName': 'Ashleigh L', 'Initials': 'AL', 'LastName': 'Chiaf', 'Affiliation': 'Department of Rural Health, Oklahoma State University Center for Health Sciences, Stillwater, USA.'}, {'ForeName': 'Erica K', 'Initials': 'EK', 'LastName': 'Crockett', 'Affiliation': 'Department of Rural Health, Oklahoma State University Center for Health Sciences, Stillwater, USA.'}, {'ForeName': 'Isaac J', 'Initials': 'IJ', 'LastName': 'Washburn', 'Affiliation': 'Department of Human Development and Family Science, Oklahoma State University, Stillwater, USA.'}]",Drug and alcohol review,['10.1111/dar.13045']
29,32404226,"Efficacy of internet-delivered acceptance and commitment therapy for severe health anxiety: results from a randomized, controlled trial.","BACKGROUND


Health anxiety is common, disabling and costly due to patients' extensive use of health care services. Internet-delivered treatment may overcome barriers of accessibility to specialized treatment. We aimed to evaluate the efficacy of internet-delivered acceptance and commitment therapy (iACT).
METHODS


A randomized, controlled trial of iACT versus an internet-delivered discussion forum (iFORUM), performed in a Danish university hospital setting. Patients self-referred and underwent video-diagnostic assessment. Eligible patients (≥18 years) with health anxiety were randomized to 12 weeks of intervention. The randomization was blinded for the assessor. The primary outcome was between-group unadjusted mean differences in health anxiety symptoms measured by the Whiteley-7 Index (WI-7, range 0-100) from baseline to 6-month follow-up (6-MFU) using intention to treat and a linear mixed model. The study is registered at clinicaltrials.gov, number NCT02735434.
RESULTS


A total of 151 patients self-referred, and 101 patients were randomized to iACT (n = 53) or iFORUM (n = 48). A mean difference in change over time of 19.0 points [95% confidence interval (CI) 10.8-27.2, p < 0.001] was shown on the WI-7, and a large standardized effect size of d = 0.80 (95% CI 0.38-1.23) at 6-MFU. The number needed to treat was 2.8 (95% CI 1.8-6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00-4.70, p = 0.050). Adverse events were few and insignificant.
CONCLUSIONS


iACT for health anxiety led to sustained effects at 6-MFU. The study contributes to the development of easily accessible treatment options and deserves wider application.",2021,"The number needed to treat was 2.8 (95% CI 1.8-6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00-4.70, p = 0.050).","['severe health anxiety', '151 patients self-referred, and 101 patients', 'Danish university hospital setting', 'Eligible patients (≥18 years) with health anxiety']","['internet-delivered acceptance and commitment therapy (iACT', 'internet-delivered discussion forum (iFORUM', 'internet-delivered acceptance and commitment therapy', 'iACT']","['number needed to treat', 'Adverse events', 'health anxiety symptoms']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3266254', 'cui_str': 'Referred by self'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",151.0,0.303182,"The number needed to treat was 2.8 (95% CI 1.8-6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00-4.70, p = 0.050).","[{'ForeName': 'Ditte', 'Initials': 'D', 'LastName': 'Hoffmann', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Noerrebrogade 44, bldg. 2C, 1, 8000Aarhus C, Denmark.'}, {'ForeName': 'Charlotte Ulrikka', 'Initials': 'CU', 'LastName': 'Rask', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Palle Juul-Jensens Boulevard 175, ent. K, 8200Aarhus, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Tomtebodavägen 18A, 5, 171 77Stockholm, Sweden.'}, {'ForeName': 'Jens Søndergaard', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Noerrebrogade 44, bldg. 2C, 1, 8000Aarhus C, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Frostholm', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Noerrebrogade 44, bldg. 2C, 1, 8000Aarhus C, Denmark.'}]",Psychological medicine,['10.1017/S0033291720001312']
30,32401557,Parent-Child Agreement on Family Accommodation Differentially Predicts Outcomes of Child-Based and Parent-Based Child Anxiety Treatment.,"Objectives : Family accommodation is linked to poor treatment outcomes for childhood anxiety. Progress in research on the role of accommodation in treatment has been hindered by the relatively weak association between child and parent reports on accommodation. In this study, we suggest that parent-child agreement on family accommodation may provide a dependable estimation of this construct, and investigated whether the level of parent-child agreement on family accommodation predicts subsequent treatment outcome. We further examined whether the effect was greater in Supportive Parenting for Anxious Childhood Emotions (SPACE), which directly targets family accommodation, than in individual child-focused cognitive behavioral therapy (CBT). Methods : Participants were 104 children (aged 6-15) with anxiety disorders, and their mothers, randomized to SPACE or CBT. Accommodation was rated by mothers and children before treatment, halfway through treatment, and at treatment end, using respective versions of Family Accommodation Scale-Anxiety. To accurately estimate agreement, we conducted multilevel response surface analysis by polynomial regression, with agreement on accommodation at each time point predicting subsequent child anxiety severity, over the course of treatment. Results : Parent-child agreement and disagreement on accommodation were significant predictors of subsequent anxiety symptom severity. Different results were obtained for SPACE and CBT, suggesting potentially distinct underlying mechanisms. Conclusions : The findings suggest treatment-specific roles of accommodation in SPACE vs. CBT. Multiple-informant assessment of accommodation provides important information, which may have important implications for optimal treatment personalization.",2021,Parent-child agreement and disagreement on accommodation were significant predictors of subsequent anxiety symptom severity.,"['Participants were 104 children (aged 6-15) with anxiety disorders, and their mothers']",['SPACE or CBT'],['Family Accommodation'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",104.0,0.0155443,Parent-child agreement and disagreement on accommodation were significant predictors of subsequent anxiety symptom severity.,"[{'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Zilcha-Mano', 'Affiliation': 'Department of Psychology, University of Haifa.'}, {'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Shimshoni', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, Child Study Center, School of Medicine.'}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Silverman', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, Child Study Center, School of Medicine.'}, {'ForeName': 'Eli R', 'Initials': 'ER', 'LastName': 'Lebowitz', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, Child Study Center, School of Medicine.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1756300']
31,31927774,"Men's Sexual Health Questionnaire score changes vs spontaneous sexual adverse event reporting in men treated with dutasteride/tamsulosin combination therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: A post hoc analysis of a prospective, randomised, placebo-controlled study.","AIM


To assess the impact of baseline characteristics on Men's Sexual Health Questionnaire (MSHQ) total scores and to evaluate the clinical relevance of MSHQ changes and their association with spontaneously reported sexual adverse events (SexAEs) in patients with benign prostatic hyperplasia.
METHODS


This was a post hoc analysis of the Phase 4 FDC116115 study, in which patients aged ≥50 years were randomised 1:1 to receive a fixed-dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg (DUT-TAM FDC), or placebo. End-points included: change in MSHQ total scores by baseline characteristics and SexAEs; cumulative distribution function for change from baseline to month 12 in MSHQ total score and the ejaculation, erection, satisfaction and sexual desire (libido) domain scores; and relationship between changes in MSHQ scores and SexAEs.
RESULTS


The intent-to-treat population comprised 489 patients (DUT-TAM FDC, n = 243; placebo, n = 246). The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs. Most patients reporting any SexAE (86% DUT-TAM FDC, 67% placebo) had a worsening of the MSHQ total score at month 12 compared with baseline. Specifically, 90% (DUT-TAM FDC) and 75% (placebo) of patients reporting an ejaculation SexAE and 73% (DUT-TAM FDC) and 87% (placebo) of patients reporting an erection SexAE had a worsening of MSHQ ejaculation and erection domain scores, respectively, at month 12. A threshold effect for incident SexAE was observed; patients showing a decrease of approximately 6-10 points in the total MSHQ score were more likely to report SexAEs.
CONCLUSION


Findings support the clinical utility of the MSHQ tool in assessing the impact of DUT-TAM on sexual function by linking numerical changes in MSHQ scores to spontaneously reported SexAEs for the first time. The threshold effect for incidence of SexAEs warrants further investigation to determine its clinical relevance.",2020,"The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs.","['benign prostatic hyperplasia', 'patients with benign prostatic hyperplasia', '489 patients (DUT-TAM FDC, n=243; placebo, n=246', 'patients aged ≥50 years']","['placebo', 'dutasteride/tamsulosin combination therapy', 'dutasteride 0.5\xa0mg and tamsulosin 0.4 mg (DUT-TAM FDC), or placebo']","['worsening of MSHQ ejaculation and erection domain scores', 'total MSHQ score', 'change in MSHQ total scores by baseline characteristics and SexAEs; cumulative distribution function for change from baseline to Month 12 in MSHQ total score and the ejaculation, erection, satisfaction and sexual desire (libido) domain scores; and relationship between changes in MSHQ scores and SexAEs', 'MSHQ scores', ""Men's Sexual Health Questionnaire (MSHQ) total scores"", ""Men's Sexual Health Questionnaire score changes"", 'MSHQ total score']","[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2926870', 'cui_str': 'Dutasteride / tamsulosin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C1593561', 'cui_str': 'Dutasteride 0.5 MG [Avodart]'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424400', 'cui_str': 'Erotic interest (observable entity)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",489.0,0.311912,"The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs.","[{'ForeName': 'Claus G', 'Initials': 'CG', 'LastName': 'Roehrborn', 'Affiliation': 'Department of Urology, UT Southwestern Medical Centre, University of Texas, Dallas, TX, USA.'}, {'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Rosen', 'Affiliation': 'HealthCore/New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Manyak', 'Affiliation': 'GSK, Washington, DC, USA.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Palacios-Moreno', 'Affiliation': 'GSK, Madrid, Spain.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Wilson', 'Affiliation': 'PAREXEL International, Durham, NC, USA.'}, {'ForeName': 'Zrinka', 'Initials': 'Z', 'LastName': 'Lulic', 'Affiliation': 'GSK, Brentford, UK.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Giuliano', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France.'}]",International journal of clinical practice,['10.1111/ijcp.13480']
32,28597471,Gabapentin for chronic neuropathic pain in adults.,"BACKGROUND


Gabapentin is commonly used to treat neuropathic pain (pain due to nerve damage). This review updates a review published in 2014, and previous reviews published in 2011, 2005 and 2000.
OBJECTIVES


To assess the analgesic efficacy and adverse effects of gabapentin in chronic neuropathic pain in adults.
SEARCH METHODS


For this update we searched CENTRAL), MEDLINE, and Embase for randomised controlled trials from January 2014 to January 2017. We also searched the reference lists of retrieved studies and reviews, and online clinical trials registries.
SELECTION CRITERIA


We included randomised, double-blind trials of two weeks' duration or longer, comparing gabapentin (any route of administration) with placebo or another active treatment for neuropathic pain, with participant-reported pain assessment.
DATA COLLECTION AND ANALYSIS


Two review authors independently extracted data and assessed trial quality and potential bias. Primary outcomes were participants with substantial pain relief (at least 50% pain relief over baseline or very much improved on Patient Global Impression of Change scale (PGIC)), or moderate pain relief (at least 30% pain relief over baseline or much or very much improved on PGIC). We performed a pooled analysis for any substantial or moderate benefit. Where pooled analysis was possible, we used dichotomous data to calculate risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNT) or harmful outcome (NNH). We assessed the quality of the evidence using GRADE and created 'Summary of findings' tables.
MAIN RESULTS


We included four new studies (530 participants), and excluded three previously included studies (126 participants). In all, 37 studies provided information on 5914 participants. Most studies used oral gabapentin or gabapentin encarbil at doses of 1200 mg or more daily in different neuropathic pain conditions, predominantly postherpetic neuralgia and painful diabetic neuropathy. Study duration was typically four to 12 weeks. Not all studies reported important outcomes of interest. High risk of bias occurred mainly due to small size (especially in cross-over studies), and handling of data after study withdrawal.In postherpetic neuralgia, more participants (32%) had substantial benefit (at least 50% pain relief or PGIC very much improved) with gabapentin at 1200 mg daily or greater than with placebo (17%) (RR 1.8 (95% CI 1.5 to 2.1); NNT 6.7 (5.4 to 8.7); 8 studies, 2260 participants, moderate-quality evidence). More participants (46%) had moderate benefit (at least 30% pain relief or PGIC much or very much improved) with gabapentin at 1200 mg daily or greater than with placebo (25%) (RR 1.8 (95% CI 1.6 to 2.0); NNT 4.8 (4.1 to 6.0); 8 studies, 2260 participants, moderate-quality evidence).In painful diabetic neuropathy, more participants (38%) had substantial benefit (at least 50% pain relief or PGIC very much improved) with gabapentin at 1200 mg daily or greater than with placebo (21%) (RR 1.9 (95% CI 1.5 to 2.3); NNT 5.9 (4.6 to 8.3); 6 studies, 1277 participants, moderate-quality evidence). More participants (52%) had moderate benefit (at least 30% pain relief or PGIC much or very much improved) with gabapentin at 1200 mg daily or greater than with placebo (37%) (RR 1.4 (95% CI 1.3 to 1.6); NNT 6.6 (4.9 to 9.9); 7 studies, 1439 participants, moderate-quality evidence).For all conditions combined, adverse event withdrawals were more common with gabapentin (11%) than with placebo (8.2%) (RR 1.4 (95% CI 1.1 to 1.7); NNH 30 (20 to 65); 22 studies, 4346 participants, high-quality evidence). Serious adverse events were no more common with gabapentin (3.2%) than with placebo (2.8%) (RR 1.2 (95% CI 0.8 to 1.7); 19 studies, 3948 participants, moderate-quality evidence); there were eight deaths (very low-quality evidence). Participants experiencing at least one adverse event were more common with gabapentin (63%) than with placebo (49%) (RR 1.3 (95% CI 1.2 to 1.4); NNH 7.5 (6.1 to 9.6); 18 studies, 4279 participants, moderate-quality evidence). Individual adverse events occurred significantly more often with gabapentin. Participants taking gabapentin experienced dizziness (19%), somnolence (14%), peripheral oedema (7%), and gait disturbance (14%).
AUTHORS' CONCLUSIONS


Gabapentin at doses of 1800 mg to 3600 mg daily (1200 mg to 3600 mg gabapentin encarbil) can provide good levels of pain relief to some people with postherpetic neuralgia and peripheral diabetic neuropathy. Evidence for other types of neuropathic pain is very limited. The outcome of at least 50% pain intensity reduction is regarded as a useful outcome of treatment by patients, and the achievement of this degree of pain relief is associated with important beneficial effects on sleep interference, fatigue, and depression, as well as quality of life, function, and work. Around 3 or 4 out of 10 participants achieved this degree of pain relief with gabapentin, compared with 1 or 2 out of 10 for placebo. Over half of those treated with gabapentin will not have worthwhile pain relief but may experience adverse events. Conclusions have not changed since the previous update of this review.",2017,Participants experiencing at least one adverse event were more common with gabapentin (63%) than with placebo (49%) (RR 1.3 (95% CI 1.2 to 1.4);,"['January 2014 to January 2017', 'people with postherpetic neuralgia and peripheral diabetic neuropathy', 'chronic neuropathic pain in adults', '5914 participants', 'four new studies (530 participants), and excluded three previously included studies (126 participants']","['gabapentin or gabapentin encarbil', 'gabapentin encarbil', 'placebo', 'Gabapentin', 'gabapentin']","['Individual adverse events', 'dizziness', 'substantial pain relief', 'analgesic efficacy and adverse effects', 'moderate-quality evidence).In painful diabetic neuropathy', 'pain intensity reduction', 'sleep interference, fatigue, and depression, as well as quality of life, function, and work', 'worthwhile pain relief', 'substantial benefit', 'peripheral oedema', 'pain relief over baseline or much or very much improved on PGIC', 'moderate benefit', 'Patient Global Impression of Change scale (PGIC)), or moderate pain relief', 'pain relief', 'risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNT) or harmful outcome (NNH', 'Serious adverse events', 'somnolence', 'gait disturbance']","[{'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia (disorder)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0011882', 'cui_str': 'Diabetic Neuropathies'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0751074', 'cui_str': 'Diabetic Neuralgia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0575081', 'cui_str': 'Gait difficulty'}]",5914.0,0.703688,Participants experiencing at least one adverse event were more common with gabapentin (63%) than with placebo (49%) (RR 1.3 (95% CI 1.2 to 1.4);,"[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Wiffen', 'Affiliation': 'Pain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics), University of Oxford, Pain Research Unit, Churchill Hospital, Oxford, Oxfordshire, UK, OX3 7LE.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Derry', 'Affiliation': ''}, {'ForeName': 'Rae F', 'Initials': 'RF', 'LastName': 'Bell', 'Affiliation': ''}, {'ForeName': 'Andrew Sc', 'Initials': 'AS', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'Thomas Rudolf', 'Initials': 'TR', 'LastName': 'Tölle', 'Affiliation': ''}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'Moore', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007938.pub4']
33,32222960,Serratus Anterior Plane Block and Intercostal Nerve Block after Thoracoscopic Surgery.,"BACKGROUND


This study aimed to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block (Group S, SAPB) and intercostal nerve block (Group I, ICNB) after single port video-assisted thoracoscopic surgery (S-VATS) in primary spontaneous pneumothorax.
METHODS


In this prospective randomized controlled study, 54 patients were randomly assigned to two groups. Patients in Group S underwent the SAPB before the surgical drape by an anesthesiologist, and in Group I, ICNBs were performed just before the wound closure after S-VATS by an attending thoracic surgeon. The primary outcome was the numeric pain rating scale (NRS) score given by the patients for pain at the surgical incision site. NRS was assessed during resting and coughing statuses at 3, 6, and 12 hours postoperatively and at the time of the chest tube removal. The secondary outcomes included the number of nonsteroidal anti-inflammatory drugs (NSAIDs) and opioid administration until time to chest tube removal.
RESULTS


There were no statistical differences between the two groups regarding age, body mass index, duration of operation, duration of anesthesia, and average NRS scores for the assigned time periods. There was no statistical significance in the number of opioid injections; however, NSAIDs were administered 2.8 times per patient in Group I, and 1.9 times per patient in Group S ( p  = 0.038).
CONCLUSION


In the patients who underwent S-VATS with primary spontaneous pneumothorax, the SAPB provided similar postoperative pain relief with reducing the NSAIDs consumption compared with ICNB.",2021,"There were no statistical differences between the two groups regarding age, body mass index, duration of operation, duration of anesthesia, and average NRS scores for the assigned time periods.","['primary spontaneous pneumothorax', '54 patients']","['ultrasound-guided serratus anterior plane block (Group S, SAPB) and intercostal nerve block (Group I, ICNB', 'single port video-assisted thoracoscopic surgery (S-VATS']","['NRS', 'number of nonsteroidal anti-inflammatory drugs (NSAIDs) and opioid administration until time to chest tube removal', 'postoperative analgesic effect', 'body mass index, duration of operation, duration of anesthesia, and average NRS scores', 'numeric pain rating scale (NRS) score given by the patients for pain', 'postoperative pain relief']","[{'cui': 'C0149781', 'cui_str': 'Primary Spontaneous Pneumothorax'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block (procedure)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2224175', 'cui_str': 'Chest tube removal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",54.0,0.1037,"There were no statistical differences between the two groups regarding age, body mass index, duration of operation, duration of anesthesia, and average NRS scores for the assigned time periods.","[{'ForeName': 'Saeyoung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Chae-Min', 'Initials': 'CM', 'LastName': 'Bae', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Young Woo', 'Initials': 'YW', 'LastName': 'Do', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Suyoung', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Seung Ik', 'Initials': 'SI', 'LastName': 'Baek', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Deok Heon', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}]",The Thoracic and cardiovascular surgeon,['10.1055/s-0040-1705152']
34,31627089,Long-term effect of the perindopril/indapamide/amlodipine single-pill combination on left ventricular hypertrophy in outpatient hypertensive subjects.,"BACKGROUND


Most antihypertensive drugs used in monotherapy or in combination therapy reduce the left ventricular mass index (LVMI). However, little is known about the effects on LVMI of a triple fixed-dose combination (TFC) therapy, containing in a single pill an angiotensin-converting enzyme inhibitor (ACEI), a diuretic and a calcium channel blocker (CCB).
METHODS


In this prospective open-label study, 92 patients with essential hypertension were randomized to treatment with a TFC of perindopril/indapamide/amlodipine at different doses or a triple free combination therapy (FCT) including ACEI/diuretic/CCB. Office blood pressure (BP) measurement, 24 h-ambulatory BP monitoring and echocardiography were performed at baseline and during a 14-month follow-up. The BP variability (BPV) over 24 h was calculated as ± standard deviation of the daytime systolic BP. Differences between office and monitored BP and LVMI were evaluated by ANOVA for repeated measures.
RESULTS


A significant BP-lowering effect was observed for both treatments. At follow-up, BPV was reduced in both the treatment groups vs. the baseline (14.0±1.5 vs. 17.0±1.8 and 16.2±2.1 vs. 17.6±2.3, respectively), but it was lower in the TFC vs. the FCT group (14.0±1.5 vs. 16.1±2.2, P < 0.05). LVMI was lower in both the treatment groups, but the change was greater for TFC vs. FCT (-8.3±4.9% vs. -2.0 ±2.1%, P < 0.0001). Left ventricular hypertrophy (LVH) regression was greater in the TFC vs. the FCT group (43.5% vs. 30.4%, P < 0.05).
CONCLUSIONS


Independently of BP values achieved, the antihypertensive TFC therapy was more effective than FCT in LVMI reduction and LVH regression, possibly related to drugs' intrinsic properties and to BPV modulation.",2019,"Independently of BP values achieved, the antihypertensive TFC therapy was more effective than FCT in LVMI reduction and LVH regression, possibly related to drugs' intrinsic properties and to BPV modulation.","['92 patients with essential hypertension', 'outpatient hypertensive subjects']","['triple free combination therapy (FCT) including ACEI/diuretic/CCB', 'perindopril/indapamide/amlodipine single-pill combination', 'FCT', 'TFC of perindopril/indapamide/amlodipine']","['daytime systolic BP', 'BPV', 'BP and LVMI', 'left ventricular hypertrophy', 'Left ventricular hypertrophy (LVH) regression', 'BP variability (BPV', 'LVMI', 'left ventricular mass index (LVMI', 'Office blood pressure (BP) measurement, 24\u2009h-ambulatory BP monitoring and echocardiography', 'BP-lowering effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy (disorder)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",92.0,0.0227168,"Independently of BP values achieved, the antihypertensive TFC therapy was more effective than FCT in LVMI reduction and LVH regression, possibly related to drugs' intrinsic properties and to BPV modulation.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Mazza', 'Affiliation': 'ESH Excellence Hypertension Centre, Internal Medicine Unit, S. Maria della Misericordia General Hospital, AULSS 5 Polesana, Rovigo, Italy. Electronic address: alberto.mazza@aulss5.veneto.it.'}, {'ForeName': 'Danyelle M', 'Initials': 'DM', 'LastName': 'Townsend', 'Affiliation': 'Department of Drug Discovery and Biomedical Sciences, Medical University of South Carolina, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schiavon', 'Affiliation': 'Unit of Internal Medicine, S. Maria della Misericordia Hospital, AULSS 5 Polesana, Rovigo, Italy.'}, {'ForeName': 'Gioia', 'Initials': 'G', 'LastName': 'Torin', 'Affiliation': 'ESH Excellence Hypertension Centre, Internal Medicine Unit, S. Maria della Misericordia General Hospital, AULSS 5 Polesana, Rovigo, Italy; Unit of Internal Medicine C, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Lenti', 'Affiliation': 'Internal Medicine Unit, S. Donato General Hospital, Arezzo, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Rossetti', 'Affiliation': 'Unit of Internal Medicine, S. Maria della Misericordia Hospital, AULSS 5 Polesana, Rovigo, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Rigatelli', 'Affiliation': 'Interventional Cardiology Unit, Division of Cardiology, S. Maria della Misericordia Hospital, AULSS 5 Polesana, Rovigo, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Rubello', 'Affiliation': 'Department of Nuclear Medicine, Radiology, Neuroradiology, Medical Physics, Clinical Laboratory, Microbiology, Pathology, Trasfusional Medicine, Santa Maria della Misericordia Hospital, Rovigo, Italy.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2019.109539']
35,31896735,Comparing treatment effects of a convenient vibratory positional device to CPAP in positional OSA: a crossover randomised controlled trial.,"OBJECTIVES


Up to 77% of patients with obstructive sleep apnoea (OSA) have positional OSA (POSA) but traditional positional therapy (PT) methods have failed as they were poorly tolerated. New convenient vibratory PT devices have been invented but while recent studies suggest high treatment efficacy and adherence, there are no published data comparing these devices directly with continuous positive airway pressure (CPAP). Our objective is to evaluate if a convenient vibratory PT device is non-inferior to CPAP in POSA treatment.
METHODS


In this crossover randomised controlled trial, we enrolled patients with POSA with significant daytime sleepiness (Epworth Sleepiness Scale (ESS)≥10). POSA diagnosis was based on: (1) total Apnoea/Hypopnoea Index (AHI)>10/hour and non-supine AHI<10/hour (2) supine AHI≥2 × non-supine AHI. Patients used their initial allocated devices (PT or CPAP) for 8 weeks before crossing to the alternative intervention after a 1 week washout. The primary aim is to measure changes in ESS between the two treatments. Secondary outcomes include sleep study parameters and patient treatment preference (ClinicalTrials.gov: NCT03125512).
RESULTS


40 patients completed the trial between April 2017 and December 2018. Difference in ESS after 8 weeks of device use (PT minus CPAP) was 2.0 (95% CI 0.68 to 3.32), exceeding our predetermined non-inferiority margin of 1.5. AHI on CPAP was lower than with PT (4.0±3.2 vs 13.0±13.8 events/hour, respectively, p=0.001), although both were lower than at baseline. Time spent supine was significantly lower with PT than CPAP (p<0.001). 60% of patients preferred CPAP, 20% preferred PT, while 20% preferred neither device.
CONCLUSIONS


The non-inferiority ESS endpoint for PT compared with CPAP was not met and the results were inconclusive. Future trials with larger sample sizes or in less symptomatic patients are warranted to provide further insight into the role of these new vibratory PT devices.",2020,Time spent supine was significantly lower with PT than CPAP (p<0.001).,"['40 patients completed the trial between April 2017 and December 2018', 'patients with obstructive sleep apnoea (OSA) have positional OSA (POSA) but', 'positional OSA', 'enrolled patients with POSA with significant daytime sleepiness (Epworth Sleepiness Scale (ESS)≥10']","['initial allocated devices (PT or CPAP', 'convenient vibratory positional device to CPAP', 'traditional positional therapy (PT', 'CPAP']","['Time spent supine', 'AHI on CPAP', 'ESS', 'total Apnoea/Hypopnoea Index (AHI)>10/hour', 'sleep study parameters and patient treatment preference (ClinicalTrials.gov: NCT03125512']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C3831015', 'cui_str': 'Convenient (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",40.0,0.0527833,Time spent supine was significantly lower with PT than CPAP (p<0.001).,"[{'ForeName': 'Yingjuan', 'Initials': 'Y', 'LastName': 'Mok', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore mok.yingjuan@singhealth.com.sg.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Pon Poh', 'Initials': 'PP', 'LastName': 'Hsu', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Seow', 'Affiliation': 'Allied Health Division, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Yiong Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University Singapore, Singapore, Singapore.'}, {'ForeName': 'Hang Siang', 'Initials': 'HS', 'LastName': 'Wong', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Poh', 'Affiliation': 'Allied Health Division, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Keith K H', 'Initials': 'KKH', 'LastName': 'Wong', 'Affiliation': 'Department of Respiratory & Sleep Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}]",Thorax,['10.1136/thoraxjnl-2019-213547']
36,32180305,The gains of a 4-week cognitive training are not modulated by novelty.,"Cognitive training should not only improve performance of the trained task, but also untrained abilities. Exposure to novelty can improve subsequent memory performance, suggesting that novelty exposure might be a critical factor to promote the effects of cognitive training. Therefore, we combined a 4-week working memory training with novelty exposure. Neuropsychological tests and MRI data were acquired before and after training to analyze behavior and changes in gray matter volume, myelination, and iron levels. In total, 83 healthy older humans participated in one of three groups: Two groups completed a 4-week computerized cognitive training of a two-back working memory task, either in combination with novel or with familiarized nature movies. A third group did not receive any training. As expected, both training groups showed improvements in task specific working memory performance and reaction times. However, there were no transfer or novelty effects on fluid intelligence, verbal memory, digit-span, and executive functions. At the neural level, no significant micro- or macrostructural changes emerged in either group. Our findings suggest that working memory training in healthy older adults is associated with task-specific improvements, but these gains do not transfer to other cognitive domains, and it does not lead to structural brain changes.",2020,"However, there were no transfer or novelty effects on fluid intelligence, verbal memory, digit-span, and executive functions.","['83 healthy older humans participated in one of three groups: Two groups completed a', 'healthy older adults']","['Cognitive training', 'working memory training', '4-week computerized cognitive training of a two-back working memory task, either in combination with novel or with familiarized nature movies']","['subsequent memory performance', 'fluid intelligence, verbal memory, digit-span, and executive functions', 'task specific working memory performance and reaction times', 'gray matter volume, myelination, and iron levels', 'Neuropsychological tests and MRI data']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0681495', 'cui_str': 'Movies'}]","[{'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",83.0,0.0118094,"However, there were no transfer or novelty effects on fluid intelligence, verbal memory, digit-span, and executive functions.","[{'ForeName': 'Davina', 'Initials': 'D', 'LastName': 'Biel', 'Affiliation': 'Institute of Psychology I, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Tineke K', 'Initials': 'TK', 'LastName': 'Steiger', 'Affiliation': 'Institute of Psychology I, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Volkmann', 'Affiliation': 'Institute for Multimedia and Interactive Systems, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Jochems', 'Affiliation': 'Institute for Multimedia and Interactive Systems, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Bunzeck', 'Affiliation': 'Institute of Psychology I, University of Lübeck, Lübeck, Germany.'}]",Human brain mapping,['10.1002/hbm.24965']
37,31704518,Brain volumes as predictors of tDCS effects in primary progressive aphasia.,"The current study aims to determine the brain areas critical for response to anodal transcranial direct current stimulation (tDCS) in PPA. Anodal tDCS and sham were administered over the left inferior frontal gyrus (IFG), combined with written naming/spelling therapy. Thirty people with PPA were included in this study, and assessed immediately, 2 weeks, and 2 months post-therapy. We identified anatomical areas whose volumes significantly predicted the additional tDCS effects. For trained words, the volumes of the left Angular Gyrus and left Posterior Cingulate Cortex predicted the additional tDCS gain. For untrained words, the volumes of the left Middle Frontal Gyrus, left Supramarginal Gyrus, and right Posterior Cingulate Cortex predicted the additional tDCS gain. These findings show that areas involved in language, attention and working memory contribute to the maintenance and generalization of stimulation effects. The findings highlight that tDCS possibly affects areas anatomically or functionally connected to stimulation targets.",2020,"For untrained words, the volumes of the left Middle Frontal Gyrus, left Supramarginal Gyrus, and right Posterior Cingulate Cortex predicted the additional tDCS gain.","['primary progressive aphasia', 'Thirty people with PPA']","['Anodal tDCS and sham were administered over the left inferior frontal gyrus (IFG), combined with written naming/spelling therapy', 'anodal transcranial direct current stimulation (tDCS']",[],"[{'cui': 'C0282513', 'cui_str': 'Mesulam Syndrome'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0152298', 'cui_str': 'Gyrus Frontalis Inferior'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],30.0,0.0361193,"For untrained words, the volumes of the left Middle Frontal Gyrus, left Supramarginal Gyrus, and right Posterior Cingulate Cortex predicted the additional tDCS gain.","[{'ForeName': 'Vânia', 'Initials': 'V', 'LastName': 'de Aguiar', 'Affiliation': 'Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, United States; Center for Language and Cognition Groningen (CLCG), University of Groningen, Netherlands. Electronic address: vania.de.aguiar@rug.nl.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Faria', 'Affiliation': 'Department of Radiology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Bronte', 'Initials': 'B', 'LastName': 'Ficek', 'Affiliation': 'Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Kimberly T', 'Initials': 'KT', 'LastName': 'Webster', 'Affiliation': 'Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Wendt', 'Affiliation': 'Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Zeyi', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Argye E', 'Initials': 'AE', 'LastName': 'Hillis', 'Affiliation': 'Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, United States; Department of Cognitive Science, Johns Hopkins University, Baltimore, MD, United States; Department of Physical Medicine & Rehabilitation, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Chiadi U', 'Initials': 'CU', 'LastName': 'Onyike', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, MD, United States; Department of Radiology, Johns Hopkins School of Medicine, Baltimore, MD, United States; Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Caffo', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Kyrana', 'Initials': 'K', 'LastName': 'Tsapkini', 'Affiliation': 'Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, United States; Department of Cognitive Science, Johns Hopkins University, Baltimore, MD, United States.'}]",Brain and language,['10.1016/j.bandl.2019.104707']
38,30826585,Government of Malawi's unconditional cash transfer improves youth mental health.,"We explore the impacts of Malawi's national unconditional cash transfer program targeting ultra-poor households on youth mental health. Experimental findings show that the program significantly improved mental health outcomes. Among girls in particular, the program reduces indications of depression by about 15 percentage points. We investigate the contribution of different possible pathways to the overall program impact, including education, health, consumption, caregiver's stress levels and life satisfaction, perceived social support, and participation in hard and unpleasant work. The pathways explain from 46 to 65 percent of the program impact, advancing our understanding of how economic interventions can affect mental health of youth in resource-poor settings. The findings underline that unconditional cash grants, which are used on an increasingly large scale as part of national social protection systems in Sub-Saharan Africa, have the potential to improve youth mental wellbeing and thus may help break the vicious cycle of poverty and poor mental health.",2019,"Among girls in particular, the program reduces indications of depression by about 15 percentage points.",['ultra-poor households on youth mental health'],[],"[""education, health, consumption, caregiver's stress levels and life satisfaction, perceived social support, and participation in hard and unpleasant work"", 'mental health outcomes']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",[],"[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1998980', 'cui_str': 'Caregiver role strain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0180407,"Among girls in particular, the program reduces indications of depression by about 15 percentage points.","[{'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Angeles', 'Affiliation': 'Department of Maternal and Child Health, University of North Carolina at Chapel Hill and MEASURE Evaluation, USA.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'de Hoop', 'Affiliation': 'Social and Economic Policy Unit, UNICEF Office of Research-Innocenti, Italy. Electronic address: jdehoop@unicef.org.'}, {'ForeName': 'Sudhanshu', 'Initials': 'S', 'LastName': 'Handa', 'Affiliation': 'Department of Public Policy, University of North Carolina at Chapel Hill, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kilburn', 'Affiliation': 'Institute for Global Health and Infectious Diseases, University of North Carolina, USA.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Milazzo', 'Affiliation': 'Social and Economic Policy Unit, UNICEF Office of Research-Innocenti, Italy.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Peterman', 'Affiliation': 'Social and Economic Policy Unit, UNICEF Office of Research-Innocenti, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.01.037']
39,32403999,Crossover effects of ultrasound-guided percutaneous neuromodulation on contralateral hamstring flexibility.,"BACKGROUND


Crossover effects refer to the responses of a non-exercised contralateral limb. There is evidence of this effect, as it relates to muscle fatigue, strength, and stretch, but not as it relates to neuromodulation.
OBJECTIVES


To compare the crossover effects of percutaneous neuromodulation (PNM) on hip range of motion (ROM), observed in a straight leg raise (SLR) test, in asymptomatic participants with bilateral reduced hamstring flexibility, versus the neurodynamic sciatic sliding technique, hamstring stretching and mechanical stimulation of the sciatic nerve using a needle (without electrical stimulation). To evaluate the tensiomyographic changes between the two lower limbs after these interventions.
METHODS


80 participants with bilateral reduced hamstring flexibility were randomized into four groups: Stretching, Neurodynamic, PNM, and Needle groups. All interventions were performed on the right limb. Each participant's leg was subjected to SLR testing and tensiomyography before and after the interventions.
RESULTS


Each group improved their SLR values in the non-intervention limb compared to baseline values, but the PNM and Needle groups obtained higher values for the SLR test in the non-intervention limb compared with the Neurodynamic and Stretching groups. There were statistically significant differences for mean SLR measures between limbs pre- and post-intervention for all groups except the PNM group, suggesting crossover effects for PNM but not the other techniques studied. There were no differences in tensiomyographic assessments between groups or between sides, at baseline or upon completion of the study.
CONCLUSION


PNM produced benefits in the SLR test in the non-intervention limb and only 1.5 min was enough to obtain this effect. In addition, no technique interfered with muscle activation.",2021,"There were statistically significant differences for mean SLR measures between limbs pre- and post-intervention for all groups except the PNM group, suggesting crossover effects for PNM but not the other techniques studied.","['80 participants with bilateral reduced hamstring flexibility', 'asymptomatic participants with bilateral reduced hamstring flexibility']","['neurodynamic sciatic sliding technique, hamstring stretching and mechanical stimulation of the sciatic nerve using a needle (without electrical stimulation', 'percutaneous neuromodulation (PNM', 'Stretching, Neurodynamic, PNM, and Needle groups', 'ultrasound-guided percutaneous neuromodulation']","['SLR values', 'hip range of motion (ROM', 'tensiomyographic assessments', 'mean SLR measures', 'contralateral hamstring flexibility']","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C1285354', 'cui_str': 'Mechanical stimulation'}, {'cui': 'C0036394', 'cui_str': 'Structure of sciatic nerve'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",80.0,0.0319151,"There were statistically significant differences for mean SLR measures between limbs pre- and post-intervention for all groups except the PNM group, suggesting crossover effects for PNM but not the other techniques studied.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, Avicena street, 41009, Seville, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carrasco-Iglesias', 'Affiliation': 'Department of Physiotherapy, University of Seville, Avicena street, 41009, Seville, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Minaya-Muñoz', 'Affiliation': 'MVClinic Institute, Madrid, Spain; Department of Physiotherapy, CEU San Pablo University, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, 28670, Madrid, Spain.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420920283']
40,32170307,A randomized controlled trial of CBT-I and PAP for obstructive sleep apnea and comorbid insomnia: main outcomes from the MATRICS study.,"STUDY OBJECTIVES


To investigate treatment models using cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) for people with obstructive sleep apnea (OSA) and comorbid insomnia.
METHODS


121 adults with OSA and comorbid insomnia were randomized to receive CBT-I followed by PAP, CBT-I concurrent with PAP, or PAP only. PAP was delivered following standard clinical procedures for in-lab titration and home setup and CBT-I was delivered in four individual sessions. The primary outcome measure was PAP adherence across the first 90 days, with regular PAP use (≥4 h on ≥70% of nights during a 30-day period) serving as the clinical endpoint. The secondary outcome measures were the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with good sleeper (PSQI <5), remission (ISI <8), and response (ISI reduction from baseline >7) serving as the clinical endpoints.
RESULTS


No significant differences were found between the concomitant treatment arms and PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint. Compared to PAP alone, the concomitant treatment arms reported a significantly greater reduction from baseline on the ISI (p = .0009) and had a greater percentage of participants who were good sleepers (p = .044) and remitters (p = .008). No significant differences were found between the sequential and concurrent treatment models on any outcome measure.
CONCLUSIONS


The findings from this study indicate that combining CBT-I with PAP is superior to PAP alone on insomnia outcomes but does not significantly improve adherence to PAP.",2020,"No significant differences were found between the concomitant treatment arms versus PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint.","['people with obstructive sleep apnea (OSA) and comorbid insomnia', '121 adults with OSA and comorbid insomnia', 'Obstructive Sleep Apnea and Comorbid Insomnia']","['cognitive-behavior therapy for insomnia (CBT-I) and positive airway pressure (PAP', 'CBT-I followed by PAP, CBT-I concurrent with PAP, or PAP only', 'CBT-I and PAP']","['PAP adherence measures', 'PAP adherence across the first 90 days, with regular PAP use', 'adherence to PAP', 'Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with good sleeper (PSQI< 5), remission (ISI< 8), and response (ISI reduction from baseline > 7) serving as the clinical endpoints']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",121.0,0.0274862,"No significant differences were found between the concomitant treatment arms versus PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint.","[{'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Ong', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Crawford', 'Affiliation': 'School of Psychological Sciences and Health, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Spencer C', 'Initials': 'SC', 'LastName': 'Dawson', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Louis F', 'Initials': 'LF', 'LastName': 'Fogg', 'Affiliation': 'College of Nursing, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Arlener D', 'Initials': 'AD', 'LastName': 'Turner', 'Affiliation': 'Center for Sleep and Brain Health, Department of Psychiatry, New York University, New York, NY.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Wyatt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Crisostomo', 'Affiliation': 'Department of Medicine, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Bantu S', 'Initials': 'BS', 'LastName': 'Chhangani', 'Affiliation': 'Department of Medicine, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Clete A', 'Initials': 'CA', 'LastName': 'Kushida', 'Affiliation': 'Division of Sleep Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Edinger', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, National Jewish Health, Denver, CO.'}, {'ForeName': 'Sabra M', 'Initials': 'SM', 'LastName': 'Abbott', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Roneil G', 'Initials': 'RG', 'LastName': 'Malkani', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Hrayr P', 'Initials': 'HP', 'LastName': 'Attarian', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}]",Sleep,['10.1093/sleep/zsaa041']
41,32151464,Choice of access site and type of anticoagulant in acute coronary syndromes with advanced Killip class or out-of-hospital cardiac arrest.,"INTRODUCTION AND OBJECTIVES


Patients who are vulnerable to hemodynamic or electrical disorders (VP) are often excluded from clinical trials and data on the optimal access-site or antithrombotic treatment are limited. We assessed outcomes of transradial vs transfemoral access and bivalirudin vs unfractionated heparin (UFH) in VP with acute coronary syndrome undergoing invasive management.
METHODS


The MATRIX trial randomized 8404 patients to radial or femoral access and 7213 patients to bivalirudin or UFH. Among them, 934 (11.1%) were deemed VP due to advanced Killip class (n = 808), cardiac arrest (n = 168), or both (n = 42). The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACE: death, myocardial infarction, or stroke) and net adverse clinical events (NACE: MACE or major bleeding).
RESULTS


MACE and NACE were similarly reduced with radial vs femoral access in VP and non-VP. Transradial access was also associated with consistent relative benefits in all-cause and cardiovascular mortality or Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding with greater absolute benefits in VP. The effects of bivalirudin vs UFH on MACE and NACE were consistent in VP and non-VP. Bivalirudin was associated with lower all-cause and cardiovascular mortality in VP but not in non-VP, with borderline interaction testing. Bivalirudin reduced bleeding in both VP and non-VP with a larger absolute benefit in VP.
CONCLUSIONS


In acute coronary syndrome patients undergoing invasive management, the effects of randomized treatments were consistent in VP and non-VP, but absolute risk reduction with radial access and bivalirudin were greater in VP, with a 5- to 10-fold lower number needed to treat for benefits. Trial registry number: NCT01433627.",2020,"Bivalirudin was associated with lower all-cause and cardiovascular mortality in VP but not in non-VP, with borderline interaction testing.","['acute coronary syndrome patients undergoing invasive management', 'acute coronary syndromes with advanced Killip class or out-of-hospital cardiac arrest', 'VP with acute coronary syndrome undergoing invasive management', '8404 patients to radial or femoral access and 7213 patients to', 'Patients who are vulnerable to hemodynamic or electrical disorders (VP']","['transradial vs transfemoral access and bivalirudin vs unfractionated heparin (UFH', 'bivalirudin vs UFH', 'Bivalirudin', 'bivalirudin', 'bivalirudin or UFH']","['cardiac arrest', 'cardiovascular mortality', 'cardiovascular mortality or Bleeding Academic Research Consortium (BARC', 'bleeding', 'major adverse cardiovascular and cerebrovascular events (MACE: death, myocardial infarction, or stroke) and net adverse clinical events (NACE: MACE or major bleeding']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",8404.0,0.0582616,"Bivalirudin was associated with lower all-cause and cardiovascular mortality in VP but not in non-VP, with borderline interaction testing.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gargiulo', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Sunnåker', 'Affiliation': 'Clinical Trials Unit (CTU) Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium & Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Frigoli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': 'Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Gragnano', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland; Division of Cardiology, Department of Translational Medical Sciences, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Manavifar', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Galea', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Alberto R', 'Initials': 'AR', 'LastName': 'De Caterina', 'Affiliation': 'Ospedale del Cuore - Massa, Fondazione Toscana ""G. Monasterio"", Pisa, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Calabrò', 'Affiliation': 'Division of Cardiology, Department of Translational Medical Sciences, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hunziker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.01.005']
42,32159313,High-frequency versus theta burst transcranial magnetic stimulation for the treatment of poststroke cognitive impairment in humans,"Background


Because the reliability of repetitive transcranial magnetic stimulation (rTMS) in treating poststroke cognitive impairment has not been convincingly demonstrated, we systematically examined the effectiveness of this regimen with 2 protocols.
Methods


We randomly allocated 41 patients with poststroke cognitive impairment to receive 5 Hz rTMS (n = 11), intermittent theta burst stimulation (iTBS; n = 15) or sham stimulation (n = 15). Each group received 10 stimulation sessions over the left dorsolateral prefrontal cortex. We performed the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Beck Depression Inventory at baseline and after the intervention.
Results


The 5 Hz rTMS group showed significantly greater improvement than the sham group in RBANS total score (p = 0.006), attention (p = 0.001) and delayed memory (p < 0.001). The iTBS group showed significantly greater improvement than the sham group in RBANS total score (p = 0.005) and delayed memory (p = 0.007). The 5 Hz rTMS group exhibited a superior modulating effect in attention compared to the iTBS group (p = 0.016). Patients without comorbid hypertension (p = 0.008) were predisposed to favourable therapeutic outcomes.
Limitations


Although we included only patients with left hemispheric stroke, heterogeneity associated with cortical and subcortical implications existed. We did not investigate the remote effects of rTMS.
Conclusion


Our results demonstrated that both 5 Hz rTMS and iTBS were effective for poststroke cognitive impairment in terms of global cognition, attention and memory function; the domain of attention was susceptible to 5 Hz modulation. Treatment with 5 Hz rTMS may slow cognitive decline, representing both a pivotal process in poststroke cognitive impairment and an aspect of neuroplasticity that contributes to disease-modifying strategies.
Clinical trial registration


NCT02006615; clinicaltrials.gov/ct2/show/NCT02006615.",2020,The iTBS group showed significantly greater improvement than the sham group in RBANS total score (p = 0.005) and delayed memory (p = 0.007).,"['41 patients with poststroke cognitive impairment to', 'poststroke cognitive impairment in humans']","['10 stimulation sessions', 'receive 5 Hz rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'Hz rTMS and iTBS', 'intermittent theta burst stimulation (iTBS; n = 15) or sham stimulation', '5 Hz rTMS', 'High-frequency versus theta burst transcranial magnetic stimulation']","['RBANS total score', 'delayed memory', 'Neuropsychological Status (RBANS) and the Beck Depression Inventory', 'comorbid hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",41.0,0.0667168,The iTBS group showed significantly greater improvement than the sham group in RBANS total score (p = 0.005) and delayed memory (p = 0.007).,"[{'ForeName': 'Po-Yi', 'Initials': 'PY', 'LastName': 'Tsai', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan (Tsai, Tsai, Kuo); the National Yang-Ming University, School of Medicine, Taipei, Taiwan (Tsai, W. Lin); the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan Branch, Yilan, Taiwan (W. Lin, P. Lin).'}, {'ForeName': 'Wang-Sheng', 'Initials': 'WS', 'LastName': 'Lin', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan (Tsai, Tsai, Kuo); the National Yang-Ming University, School of Medicine, Taipei, Taiwan (Tsai, W. Lin); the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan Branch, Yilan, Taiwan (W. Lin, P. Lin).'}, {'ForeName': 'Kun-Ting', 'Initials': 'KT', 'LastName': 'Tsai', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan (Tsai, Tsai, Kuo); the National Yang-Ming University, School of Medicine, Taipei, Taiwan (Tsai, W. Lin); the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan Branch, Yilan, Taiwan (W. Lin, P. Lin).'}, {'ForeName': 'Chia-Yu', 'Initials': 'CY', 'LastName': 'Kuo', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan (Tsai, Tsai, Kuo); the National Yang-Ming University, School of Medicine, Taipei, Taiwan (Tsai, W. Lin); the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan Branch, Yilan, Taiwan (W. Lin, P. Lin).'}, {'ForeName': 'Pei-Hsin', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan (Tsai, Tsai, Kuo); the National Yang-Ming University, School of Medicine, Taipei, Taiwan (Tsai, W. Lin); the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan Branch, Yilan, Taiwan (W. Lin, P. Lin).'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.190060']
43,32152813,"Hidden blood loss in direct anterior total hip arthroplasty: a prospective, double blind, randomized controlled trial on topical versus intravenous tranexamic acid.","BACKGROUND


Despite a plethora of literature reporting on the use of tranexamic acid (TXA) in total hip arthroplasty (THA), little is available on its effect on post-operative hidden blood loss and even less on its use in the direct anterior approach (DAA), which is gaining popularity.
MATERIALS AND METHODS


This study was designed as a prospective, double blind, single centre, randomized controlled trial. Sixty patients were allocated to intravenous administration of 1.5 g of TXA just before wound closure while 60 patients were allocated to topical application of 3.0 g of TXA via a subfascial drain at the end of the procedure. Post-operative blood loss was (1) calculated via a well-established formula based on pre- and post-operative Hb levels, patients characteristics and intra-operative blood loss and (2) measured via the amount that collected in the subfascial drain over time.
RESULTS


No statistical significant difference in post-operative blood loss was found, neither when the formula was used (0.55 L [topical] vs 0.67 L [IV]; p = .140) nor when looking at the drain output (0.25 L [topical] vs 0.29 L [IV]; p = .108). No significant difference in secondary outcome measures, such as transfusion of units of packed red blood cells, length of hospital stay or the occurrence of venous thromboembolisms, could be found either.
CONCLUSIONS


This study provides detailed insights into the intra- and post-operative blood loss in DAA THA and shows that topical and IV TXA have similar effects on hidden blood loss. Clinical Trial Number: NCT01940692.
LEVEL OF EVIDENCE I


Level I-Randomized Controlled Trial.",2021,"No significant difference in secondary outcome measures, such as transfusion of units of packed red blood cells, length of hospital stay or the occurrence of venous thromboembolisms, could be found either.
","['direct anterior total hip arthroplasty', 'total hip arthroplasty (THA', 'Sixty patients']","['tranexamic acid (TXA', 'tranexamic acid', 'TXA']","['Hidden blood loss', 'transfusion of units of packed red blood cells, length of hospital stay or the occurrence of venous thromboembolisms', 'hidden blood loss', 'post-operative blood loss']","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C1719994', 'cui_str': 'Animal hide'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",60.0,0.435319,"No significant difference in secondary outcome measures, such as transfusion of units of packed red blood cells, length of hospital stay or the occurrence of venous thromboembolisms, could be found either.
","[{'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Vles', 'Affiliation': 'Department of Orthopaedic Surgery, University Hospitals Leuven - Gasthuisberg, Herestraat 49, 3000, Leuven, Belgium. gfvles@gmail.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Corten', 'Affiliation': 'Department of Orthopaedic Surgery, ZOL Genk, Genk, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Driesen', 'Affiliation': 'Department of Orthopaedic Surgery, ZOL Genk, Genk, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'van Elst', 'Affiliation': 'Department of Orthopaedic Surgery, AZ Nikolaas, Sint-Niklaas, Belgium.'}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Ghijselings', 'Affiliation': 'Department of Orthopaedic Surgery, University Hospitals Leuven - Gasthuisberg, Herestraat 49, 3000, Leuven, Belgium.'}]",Musculoskeletal surgery,['10.1007/s12306-020-00652-0']
44,31167050,Longer-Term Assessment of Azithromycin for Reducing Childhood Mortality in Africa.,"BACKGROUND


The MORDOR I trial (Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance) showed that in Niger, mass administration of azithromycin twice a year for 2 years resulted in 18% lower postneonatal childhood mortality than administration of placebo. Whether this benefit could increase with each administration or wane owing to antibiotic resistance was unknown.
METHODS


In the Niger component of the MORDOR I trial, we randomly assigned 594 communities to four twice-yearly distributions of either azithromycin or placebo to children 1 to 59 months of age. In MORDOR II, all these communities received two additional open-label azithromycin distributions. All-cause mortality was assessed twice yearly by census workers who were unaware of participants' original assignments.
RESULTS


In the MORDOR II trial, the mean (±SD) azithromycin coverage was 91.3±7.2% in the communities that received twice-yearly azithromycin for the first time (i.e., had received placebo for 2 years in MORDOR I) and 92.0±6.6% in communities that received azithromycin for the third year (i.e., had received azithromycin for 2 years in MORDOR I). In MORDOR II, mortality was 24.0 per 1000 person-years (95% confidence interval [CI], 22.1 to 26.3) in communities that had originally received placebo in the first year and 23.3 per 1000 person-years (95% CI, 21.4 to 25.5) in those that had originally received azithromycin in the first year, with no significant difference between groups (P = 0.55). In communities that had originally received placebo, mortality decreased by 13.3% (95% CI, 5.8 to 20.2) when the communities received azithromycin (P = 0.007). In communities that had originally received azithromycin and continued receiving it for an additional year, the difference in mortality between the third year and the first 2 years was not significant (-3.6%; 95% CI, -12.3 to 4.5; P = 0.50).
CONCLUSIONS


We found no evidence that the effect of mass administration of azithromycin on childhood mortality in Niger waned in the third year of treatment. Childhood mortality decreased when communities that had originally received placebo received azithromycin. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT02047981.).",2019,"In communities that had originally received placebo, mortality decreased by 13.3% (95% CI, 5.8 to 20.2) when the communities received azithromycin (P = 0.007).",['Africa'],"['Azithromycin', 'azithromycin or placebo', 'azithromycin', 'placebo']","['Childhood mortality', 'childhood mortality', 'postneonatal childhood mortality', 'mortality', 'Childhood Mortality', 'mean (±SD) azithromycin coverage']","[{'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",,0.337635,"In communities that had originally received placebo, mortality decreased by 13.3% (95% CI, 5.8 to 20.2) when the communities received azithromycin (P = 0.007).","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Nameywa', 'Initials': 'N', 'LastName': 'Boubacar', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Sanoussi', 'Initials': 'S', 'LastName': 'Elh Adamou', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Moussa Ali', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ray', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'E Kelly', 'Initials': 'EK', 'LastName': 'Callahan', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Emerson', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}]",The New England journal of medicine,['10.1056/NEJMoa1817213']
45,32146687,Barbed sutures reduce arthrotomy closure duration compared to interrupted conventional sutures for total knee arthroplasty: a randomized controlled trial.,"BACKGROUND


The broad aim of this study was to compare the safety and efficacy of using barbed sutures versus standard-of-care sutures for closure of arthrotomy during total knee arthroplasty. Specifically, we compared the duration of arthrotomy closure, the number of sutures utilized for arthrotomy closure, and 90-day outcomes, including wound-related readmission, reoperation, and complications.
MATERIALS AND METHODS


A total of 60 patients undergoing primary total knee arthroplasty were enrolled in a prospective, blinded trial and randomized to receive either running closure of the arthrotomy with barbed sutures (n = 30) or interrupted closure with standard-of-care sutures (n = 30).
RESULTS


Arthrotomy closure time was significantly shorter in the barbed suture group (3 min ± 2 min) versus the standard-of-care group (13 min ± 5 min, p < 0.001). The average suture utilization for arthrotomy closure was 1 suture (range 1-2) versus 3 sutures (range 2-4) in the standard-of-care group (p < 0.001). The overall number of wound-related complications in the barbed suture group was 3/30 (10%) versus 3/30 (10%) in the standard-of-care group (p = 1.00). There was one dehiscence 1/30 (3%) in the standard-of-care group versus zero in the barbed suture group (p = 1.00). The rate of superficial surgical site infection was 1/30 (3%) in barbed suture versus zero in the standard-of-care groups (p = 1.00).
CONCLUSION


These results suggest barbed suture utilization may be faster and more resource-efficient than the use of standard-of-care sutures for arthrotomy closure in primary total knee arthroplasty without increased complications. CLINICALTRIALS.
GOV IDENTIFIER


NCT03285529.",2021,"RESULTS


Arthrotomy closure time was significantly shorter in the barbed suture group (3 min ± 2 min) versus the standard-of-care group (13 min ± 5 min, p < 0.001).","['closure of arthrotomy during total knee arthroplasty', 'total knee arthroplasty', '60 patients undergoing primary\xa0total knee arthroplasty']","['Barbed sutures reduce arthrotomy closure duration compared to interrupted conventional sutures', 'running closure of the arthrotomy with barbed sutures (n\u2009=\u200930) or interrupted closure with standard-of-care sutures', 'barbed sutures versus standard-of-care sutures', 'barbed suture']","['Arthrotomy closure time', 'rate of superficial surgical site infection', 'average suture utilization for arthrotomy closure', 'overall number of wound-related complications', 'duration of arthrotomy closure, the\xa0number of sutures utilized for arthrotomy closure, and 90-day outcomes, including wound-related readmission, reoperation, and complications', 'safety and efficacy']","[{'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0185160', 'cui_str': 'Arthrotomy (procedure)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0185160', 'cui_str': 'Arthrotomy (procedure)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0185160', 'cui_str': 'Arthrotomy (procedure)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0457280', 'cui_str': 'Number of sutures (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.141177,"RESULTS


Arthrotomy closure time was significantly shorter in the barbed suture group (3 min ± 2 min) versus the standard-of-care group (13 min ± 5 min, p < 0.001).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sundaram', 'Affiliation': 'Department of Orthopedic Surgery, Cleveland Clinic, A41, 9500 Euclid Ave, Cleveland, OH, 44195, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Warren', 'Affiliation': 'Department of Orthopedic Surgery, Cleveland Clinic, A41, 9500 Euclid Ave, Cleveland, OH, 44195, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Klika', 'Affiliation': 'Department of Orthopedic Surgery, Cleveland Clinic, A41, 9500 Euclid Ave, Cleveland, OH, 44195, USA.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Piuzzi', 'Affiliation': 'Department of Orthopedic Surgery, Cleveland Clinic, A41, 9500 Euclid Ave, Cleveland, OH, 44195, USA. piuzzin@ccf.org.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Mont', 'Affiliation': 'Department of Orthopedic Surgery, Lenox Hill Hospital, New York, NY, 10075, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Krebs', 'Affiliation': 'Department of Orthopedic Surgery, Cleveland Clinic, A41, 9500 Euclid Ave, Cleveland, OH, 44195, USA.'}]",Musculoskeletal surgery,['10.1007/s12306-020-00654-y']
46,31910050,"A Population-Level, Randomized Effectiveness Trial of Recruitment Strategies for Parenting Programs in Elementary Schools.","Objective : A population-level, randomized controlled trial was conducted to test the effectiveness of a parent recruitment package for increasing initial engagement into a school-based parenting program and to identify strategies responsible for effects. Method : Participants were caregivers of kindergarten- to third-grade students ( N  = 1,276) attending one of five schools serving ethnically diverse families living in mostly low-income, urban conditions. First, families were randomly assigned to be recruited for research surveys or not, and then to a parenting program recruitment condition: 1) Engagement-as-usual (EAU) informational flyer; 2) EAU + testimonial booklet; 3) EAU + teacher endorsement; 4) EAU + recruitment call; or 5) all strategies (full package). Caregivers were offered a free parenting program at their child's school. Primary dependent variables were parenting program enrollment and attending at least one session (initiation). Exploratory analyses were conducted on program completion, attendance across sessions, homework completion, and in-session participation. Results : In the population-level sample, enrollment and initiation were higher for the full package compared to all other conditions except the recruitment call condition. Enrollment, initiation, and program completion were higher for the recruitment call and full package conditions compared to the EAU condition. In the subsample of initiators, parents in the full package condition attended fewer parenting sessions than in the EAU condition. Controlling for attendance across sessions, there were no condition effects on homework completion or in-session participation. Conclusions : The recruitment call can increase the public health impact of evidence-based parenting programs by improving enrollment, initiation, and program completion.",2021,"Enrollment, initiation, and program completion were higher for the recruitment call and full package conditions compared to the EAU condition.","['Participants were caregivers of kindergarten- to third-grade students ( N  =\xa01,276) attending one of five schools serving ethnically diverse families living in mostly low-income, urban conditions', 'Parenting Programs in Elementary Schools']","['parenting program recruitment condition: 1) Engagement-as-usual (EAU) informational flyer; 2) EAU + testimonial booklet; 3) EAU + teacher endorsement; 4) EAU + recruitment call; or 5) all strategies (full package', 'parent recruitment package']",['parenting program enrollment and attending at least one session (initiation'],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C1704710', 'cui_str': 'Package'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",1276.0,0.10721,"Enrollment, initiation, and program completion were higher for the recruitment call and full package conditions compared to the EAU condition.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Abraczinskas', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Winslow', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Oswalt', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Proulx', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Sharlene', 'Initials': 'S', 'LastName': 'Wolchik', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Sandler', 'Affiliation': 'Department of Psychology, Arizona State University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1703711']
47,31791663,Intravitreal Combined Aflibercept + Anti-Platelet-Derived Growth Factor Receptor β for Neovascular Age-Related Macular Degeneration: Results of the Phase 2 CAPELLA Trial.,"PURPOSE


To compare the efficacy and safety of intravitreal aflibercept + anti-platelet-derived growth factor receptor β (PDGFRβ) combination with intravitreal aflibercept injection (IAI) monotherapy in patients with treatment-naïve neovascular age-related macular degeneration (nAMD).
DESIGN


Phase 2, randomized, double-masked study.
PARTICIPANTS


A total of 505 patients (eyes) with nAMD.
METHODS


Patients were randomized 1:2:2 to low-dose combination intravitreal anti-PDGFRβ 1 mg and aflibercept 2 mg (LD combo), high-dose combination intravitreal anti-PDGFRβ 3 mg and aflibercept 2 mg (HD combo), or IAI alone every 4 weeks through week 12. At week 12, patients in the HD combo and IAI groups were re-randomized to continue as assigned or switch to HD combo → IAI or IAI → HD combo and dosed every 4 weeks through week 28. During weeks 28 to 52, patients received treatment as needed per prespecified criteria. This report presents efficacy through week 28 and safety through week 52.
MAIN OUTCOME MEASURES


Mean best-corrected visual acuity (BCVA) change from baseline at week 12 (primary end point).
RESULTS


At week 12, mean BCVA gains from baseline were 5.8, 5.8, and 7.5 letters with LD combo, HD combo, and IAI, respectively (P = 0.21 for LD combo and P = 0.10 for HD combo vs. IAI). The corresponding proportions of eyes that gained ≥15 letters were 12%, 19%, and 22%, respectively. Mean reductions in central retinal thickness from baseline were 126.1, 127.1, and 126.9 μm, respectively. Proportions of eyes with complete resolution of fluid from baseline were 35%, 24%, and 42%, respectively. Vision and anatomic outcomes at week 28 were consistent with the week 12 results. Through week 52, the incidence of intraocular inflammation was 1.0%, 7.5%, 2.1%, 2.1%, and 0%, respectively. The incidence of Anti-Platelet Trialists' Collaboration-defined arterial thromboembolic events was 1.9%, 0.9%, 1.1%, 2.1%, and 1.9%, respectively.
CONCLUSIONS


Intravitreal aflibercept + anti-PDGFRβ did not improve BCVA over IAI alone. Anatomic outcomes evaluating complete fluid resolution favored IAI. Adverse events were consistent with the reported IAI safety profile, except for a higher frequency of intraocular inflammation in the HD combo group.",2020,"CONCLUSIONS


Intravitreal aflibercept + anti-PDGFRβ did not improve BCVA over IAI alone.","['Patients', 'A total of 505 patients (eyes) with nAMD', 'Neovascular Age-Related Macular Degeneration', 'patients with treatment-naïve neovascular age-related macular degeneration (nAMD']","['Intravitreal Combined Aflibercept\xa0+ Anti-Platelet-Derived Growth Factor Receptor β', 'intravitreal aflibercept\xa0+ anti-platelet-derived growth factor receptor β (PDGFRβ) combination with intravitreal aflibercept injection (IAI) monotherapy', 'combination intravitreal anti-PDGFRβ 1 mg and aflibercept 2 mg (LD combo), high-dose combination intravitreal anti-PDGFRβ 3 mg and aflibercept 2 mg (HD combo), or IAI alone']","['Mean reductions in central retinal thickness', 'intraocular inflammation', 'Mean best-corrected visual acuity (BCVA) change', ""incidence of Anti-Platelet Trialists' Collaboration-defined arterial thromboembolic events"", 'efficacy and safety', 'Adverse events', 'mean BCVA gains', 'incidence of intraocular inflammation', 'BCVA', 'Vision and anatomic outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0071253', 'cui_str': 'Platelet-Derived Growth Factor Receptor'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}]",505.0,0.165178,"CONCLUSIONS


Intravitreal aflibercept + anti-PDGFRβ did not improve BCVA over IAI alone.","[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Nadia K', 'Initials': 'NK', 'LastName': 'Waheed', 'Affiliation': 'New England Eye Center, Boston, Massachusetts.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Kitchens', 'Affiliation': 'Retina Associates of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'Retina Research Institute of Texas, Abilene, Texas.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vitti', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Lorah', 'Initials': 'L', 'LastName': 'Perlee', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Chu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leal', 'Affiliation': 'Bayer Healthcare, Berlin, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Asmus', 'Affiliation': 'Bayer Healthcare, Berlin, Germany.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Son', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmelter', 'Affiliation': 'Bayer Healthcare, Berlin, Germany.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas. Electronic address: dmbmd@houstonretina.com.'}]",Ophthalmology,['10.1016/j.ophtha.2019.09.021']
48,31929401,Brief Report: Phase IIa Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Young Women.,"BACKGROUND


Young women aged 15-24 years are disproportionately affected by the HIV epidemic. Two phase III trials of a vaginal ring containing 25-mg dapivirine demonstrated HIV-1 risk reduction in adult women older than 21 years but not in those aged 18-21 years. Lack of protection was correlated with low adherence.
METHODS


In this phase-IIa, randomized, double-blind, placebo-controlled, US, multicenter trial of the dapivirine ring in sexually active females, aged 15-17 years, participants were randomized 3:1 to a dapivirine or placebo ring to be inserted monthly for 6 months (NCT02028338). Primary safety end points included grade 2 product related adverse events and any grade 3 and higher adverse events. Adherence to ring use was assessed by plasma dapivirine concentrations, residual levels in used rings, and self-report. A plasma dapivirine concentration of >95 pg/mL was used to define short-term adherence; a residual ring level of <23.5 mg was used to define long-term adherence. Acceptability was assessed through computer-assisted self-interviews.
RESULTS


Ninety-six participants were enrolled across 6 US sites. The median age was 16.0 years. There were no differences in safety outcomes between treatment arms. Adherence to the dapivirine ring was demonstrated by both plasma measurements (87%) and residual drug levels in rings (95%). Forty-two percent (95% confidence interval: 32 to 52) of participants reported that they never removed the ring. Participants noted no discomfort due to the ring at 87% of visits and ""liking"" the ring at 93% of visits.
CONCLUSION


The dapivirine vaginal ring, a promising topical microbicide, was well tolerated and acceptable in young US adolescents.",2020,"Participants noted no discomfort due to the ring at 87% of visits and ""liking"" the ring at 93% of visits.
","['adult women older than 21 years but not in those aged 18-21 years', 'sexually active females, aged 15-17 years', 'Ninety-six participants were enrolled across 6 US sites', 'Forty-two percent', 'Adolescent Young Women', 'young US adolescents', 'Young women aged 15-24 years']","['vaginal ring containing 25-mg dapivirine', 'placebo', 'dapivirine or placebo', 'Vaginal Ring Containing Dapivirine', 'dapivirine ring']","['HIV-1 risk reduction', 'safety outcomes', 'grade 2 product related adverse events and any grade 3 and higher adverse events', 'plasma dapivirine concentrations, residual levels in used rings, and self-report', 'residual drug levels', 'Acceptability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}]","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0428212', 'cui_str': 'Finding of drug level (finding)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",96.0,0.367086,"Participants noted no discomfort due to the ring at 87% of visits and ""liking"" the ring at 93% of visits.
","[{'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Bunge', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'FHI 360, Durham, NC.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Szydlo', 'Affiliation': 'Fred Hutchinson Cancer Research Center- Statistical Center for HIV/AIDS Research and Prevention, Seattle, WA.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Fred Hutchinson Cancer Research Center- Statistical Center for HIV/AIDS Research and Prevention, Seattle, WA.'}, {'ForeName': 'Aditya H', 'Initials': 'AH', 'LastName': 'Gaur', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reirden', 'Affiliation': 'Departments of Pediatrics and Internal Medicine, University of Colorado, Denver, CO.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'The Fenway Institute, Boston, MA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Futterman', 'Affiliation': ""Department of Pediatrics, Children's Hospital at Montefiore Medical Center, The Bronx, NY.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hoesley', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Pamina M', 'Initials': 'PM', 'LastName': 'Gorbach', 'Affiliation': 'Department of Epidemiology, University of California at Los Angeles Fielding School of Public Health, Los Angeles, CA.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Kapogiannis', 'Affiliation': 'Maternal and Pediatric Infectious Disease Branch, National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Annalene', 'Initials': 'A', 'LastName': 'Nel', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Squires', 'Affiliation': 'Merck Research Labs, Rahway, NJ; and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002244']
49,31888378,Laboratory Findings After Urinary Tract Infection and Antimicrobial Prophylaxis in Children With Vesicoureteral Reflux.,"It is a common practice to monitor blood tests in patients receiving long-term trimethoprim-sulfamethoxazole (TMP-SMZ) prophylaxis for recurrent urinary tract infections. This multicenter, randomized, placebo-controlled trial enrolled 607 children aged 2 to 71 months with vesicoureteral reflux diagnosed after symptomatic urinary tract infection. Study participants received TMP-SMZ (n = 302) or placebo (n = 305) and were followed for 2 years. Serum electrolytes (n ≥ 370), creatinine (n = 310), and complete blood counts (n ≥ 206) were measured at study entry and at the 24-month study conclusion. We found no significant electrolyte, renal, or hematologic abnormalities when comparing the treatment and placebo groups. We observed changes in several laboratory parameters in both treatment and placebo groups as would normally be expected with physiologic maturation. Changes were within the normal range for age. Long-term use of TMP-SMX had no treatment effect on complete blood count, serum electrolytes, or creatinine. Our findings do not support routine monitoring of these laboratory tests in children receiving long-term TMP-SMZ prophylaxis.",2020,"Long-term use of TMP-SMX had no treatment effect on complete blood count, serum electrolytes, or creatinine.","['patients receiving long-term', 'Children With Vesicoureteral Reflux', 'children receiving long-term TMP-SMZ prophylaxis', '607 children aged 2 to 71 months with vesicoureteral reflux diagnosed after symptomatic urinary tract infection']","['placebo', 'TMP-SMX', 'trimethoprim-sulfamethoxazole (TMP-SMZ) prophylaxis', 'TMP-SMZ']","['Serum electrolytes (n ≥ 370), creatinine (n = 310), and complete blood counts (n ≥ 206', 'complete blood count, serum electrolytes, or creatinine', 'significant electrolyte, renal, or hematologic abnormalities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteral Reflux'}, {'cui': 'C0625823', 'cui_str': 'TMPS'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0625823', 'cui_str': 'TMPS'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum (procedure)'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",607.0,0.253822,"Long-term use of TMP-SMX had no treatment effect on complete blood count, serum electrolytes, or creatinine.","[{'ForeName': 'Milan Dattaram', 'Initials': 'MD', 'LastName': 'Nadkarni', 'Affiliation': 'Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Tej K', 'Initials': 'TK', 'LastName': 'Mattoo', 'Affiliation': ""Children's Hospital of Michigan, Detroit, MI, USA.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gravens-Mueller', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Myra A', 'Initials': 'MA', 'LastName': 'Carpenter', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Marva', 'Initials': 'M', 'LastName': 'Moxey-Mims', 'Affiliation': ""Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Saul P', 'Initials': 'SP', 'LastName': 'Greenfield', 'Affiliation': 'State University of New York at Buffalo, NY, USA.'}, {'ForeName': 'Ranjiv', 'Initials': 'R', 'LastName': 'Mathews', 'Affiliation': 'Southern Illinois University, Springfield, IL, USA.'}]",Clinical pediatrics,['10.1177/0009922819898185']
50,31801739,Response to: 'Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care' by Parperis  et al .,,2021,,[],"['naproxen and low-dose colchicine', 'Naproxen or low-dose colchicine']",[],[],"[{'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}]",[],,0.0509328,,"[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Roddy', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, UK e.roddy@keele.ac.uk.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Mallen', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216671']
51,18620950,"Effect of intermittent preventive treatment of malaria on health and education in schoolchildren: a cluster-randomised, double-blind, placebo-controlled trial.","BACKGROUND


Malaria is a major cause of morbidity and mortality in early childhood, yet its consequences for health and education during the school-age years remain poorly understood. We examined the effect of intermittent preventive treatment (IPT) in reducing anaemia and improving classroom attention and educational achievement in semi-immune schoolchildren in an area of high perennial transmission.
METHODS


A stratified, cluster-randomised, double-blind, placebo-controlled trial of IPT was done in 30 primary schools in western Kenya. Schools were randomly assigned to treatment (sulfadoxine-pyrimethamine in combination with amodiaquine or dual placebo) by use of a computer-generated list. Children aged 5-18 years received three treatments at 4-month intervals (IPT n=3535, placebo n=3223). The primary endpoint was the prevalence of anaemia, defined as a haemoglobin concentration below 110 g/L. This outcome was assessed through cross-sectional surveys 12 months post-intervention. Analysis was by both intention to treat, excluding children with missing data, and per protocol. This study is registered with ClinicalTrials.gov, number NCT00142246.
FINDINGS


2604 children in the IPT group and 2302 in the placebo group were included in the intention-to-treat analysis of the primary outcome; the main reason for exclusion was loss to follow-up. Prevalence of anaemia at 12 months averaged 6.3% in the IPT group and 12.6% in the placebo group (adjusted risk ratio 0.52, 95% CI 0.29-0.93; p=0.028). Significant improvements were also seen in two of the class-based tests of sustained attention, with a mean increase in code transmission test score of 6.05 (95% CI 2.83-9.27; p=0.0007) and counting sounds test score of 1.80 (0.19-3.41; p=0.03), compared with controls. No effect was shown for inattentive or hyperactive-compulsive behaviours or on educational achievement. The per-protocol analysis yielded similar results. 23 serious adverse events were reported within 28 days of any treatment (19 in the IPT group and four in the placebo group); the main side-effects were problems of balance, dizziness, feeling faint, nausea, and/or vomiting shortly after treatment.
INTERPRETATION


IPT of malaria improves the health and cognitive ability of semi-immune schoolchildren. Effective malaria interventions could be a valuable addition to school health programmes.",2008,"Prevalence of anaemia at 12 months averaged 6.3% in the IPT group and 12.6% in the placebo group (adjusted risk ratio 0.52, 95% CI 0.29-0.93; p=0.028).","['malaria on health and education in schoolchildren', 'semi-immune schoolchildren in an area of high perennial transmission', 'semi-immune schoolchildren', 'Children aged 5-18 years', '2604 children in the IPT group and 2302 in the', '30 primary schools in western Kenya']","['sulfadoxine-pyrimethamine in combination with amodiaquine or dual placebo', 'IPT', 'intermittent preventive treatment (IPT', 'placebo']","['problems of balance, dizziness, feeling faint, nausea, and/or vomiting', 'prevalence of anaemia, defined as a haemoglobin concentration', 'inattentive or hyperactive-compulsive behaviours', 'code transmission test score', 'anaemia and improving classroom attention and educational achievement', 'Prevalence of anaemia', '23 serious adverse events']","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine / Sulfadoxine'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0581879', 'cui_str': 'Feeling faint (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C0600104', 'cui_str': 'Compulsive Behavior'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013658', 'cui_str': 'Educational Achievement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2604.0,0.757175,"Prevalence of anaemia at 12 months averaged 6.3% in the IPT group and 12.6% in the placebo group (adjusted risk ratio 0.52, 95% CI 0.29-0.93; p=0.028).","[{'ForeName': 'Siân E', 'Initials': 'SE', 'LastName': 'Clarke', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK. Electronic address: sian.clarke@lshtm.ac.uk.'}, {'ForeName': 'Matthew Ch', 'Initials': 'MC', 'LastName': 'Jukes', 'Affiliation': 'Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'J Kiambo', 'Initials': 'JK', 'LastName': 'Njagi', 'Affiliation': 'Division of Malaria Control, Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Lincoln', 'Initials': 'L', 'LastName': 'Khasakhala', 'Affiliation': 'African Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Cundill', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Otido', 'Affiliation': 'Institute of Tropical and Infectious Diseases, University of Nairobi, Kenya.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Crudder', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Benson Ba', 'Initials': 'BB', 'LastName': 'Estambale', 'Affiliation': 'Institute of Tropical and Infectious Diseases, University of Nairobi, Kenya.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Brooker', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK; Malaria Public Health and Epidemiology Group, Centre for Geographic Medicine Research-Coast, KEMRI-Wellcome Trust Collaborative Programme, Nairobi, Kenya.'}]","Lancet (London, England)",['10.1016/S0140-6736(08)61034-X']
52,30291997,Implementing community health worker-patient pairings at the time of hospital discharge: A randomized control trial.,"BACKGROUND


In 2011, there were approximately 3.3 million adult 30-day all-cause hospital readmissions in the US generating $41.3 billion in hospital costs. Community health worker (CHW) care delivery is one of very few interventions demonstrated to reduce health care utilization among populations with chronic disease. While there are a number of studies demonstrating improved disease-specific outcomes with CHW interventions, studies examining the effect of CHW care delivery on 30-day readmission rates are rare.
METHODS


This study is a randomized control trial designed to determine if linking hospitalized patients with chronic disease to community health workers (CHWs) can decrease 30-day readmissions. Participants were randomly assigned to receive the 30-day CHW intervention or usual care (no CHW). All study participants completed surveys at baseline and the end of the study 30 days post-discharge. The primary outcome was 30-day readmission and secondary outcomes included emergency department visits, missed appointments, and patient satisfaction.
RESULTS


We plan to enroll 1200 hospitalized patients during a 24-month intervals. As of December 2017, 350 patients have been consented and randomly assigned to either the intervention or control arm. A number of challenges have been encountered in implementing a CHW initiative at the time of hospital discharge.
CONCLUSION


This trial tests the effectiveness of CHW care delivery at the time of hospital discharge in reducing 30-day readmission rates and improving outcomes among patients with chronic disease. We describe and discuss challenges in launching this CHW intervention and strategies utilized to overcome these obstacles. Clinical Trials.gov registration submitted 3/14/2017: Protocol ID# 2017A050810 and Clinical Trials.gov ID# NCT03085264 Community Health Worker Care Transitions Study (C-CAT).",2018,Community health worker (CHW) care delivery is one of very few interventions demonstrated to reduce health care utilization among populations with chronic disease.,"['Implementing community health worker-patient pairings at the time of hospital discharge', 'patients with chronic disease', 'hospitalized patients with chronic disease to community health workers (CHWs', '350 patients', 'populations with chronic disease', '1200 hospitalized patients during a 24-month intervals']",['30-day CHW intervention or usual care (no CHW'],"['30-day readmission rates', '30-day readmission and secondary outcomes included emergency department visits, missed appointments, and patient satisfaction']","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",,0.157847,Community health worker (CHW) care delivery is one of very few interventions demonstrated to reduce health care utilization among populations with chronic disease.,"[{'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: jcarter0@partners.org.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Walton', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA. Electronic address: amwalton@partners.org.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Donelan', 'Affiliation': 'Mongan Institute for Health Policy Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: kdonelan@partners.org.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thorndike', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: athorndike@partners.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.09.013']
53,30465137,Control of metabolic predisposition to cardiovascular complications of chronic kidney disease by effervescent calcium magnesium citrate: a feasibility study.,"AIMS


Cardiovascular (CV) complications are common in chronic kidney disease (CKD). Numerous metabolic disturbances including hyperphosphatemia, high circulating calciprotein particles (CPP), hyperparathyroidism, metabolic acidosis, and magnesium deficiency are associated with, and likely pathogenic for CV complications in CKD. The goal of this feasibility study was to determine whether effervescent calcium magnesium citrate (EffCaMgCit) ameliorates the aforementioned pathogenic intermediates.
METHODS


Nine patients with Stage 3 and nine patients with Stage 5D CKD underwent a randomized crossover study, where they took EffCaMgCit three times daily for 7 days in one phase, and a conventional phosphorus binder calcium acetate (CaAc) three times daily for 7 days in the other phase. Two-hour postprandial blood samples were obtained on the day before and on the 7th day of treatment.
RESULTS


In Stage 5D CKD, EffCaMgCit significantly increased T50 (half time for conversion of primary to secondary CPP) from baseline by 63% (P = 0.013), coincident with statistically non-significant declines in serum phosphorus by 25% and in saturation of octacalcium phosphate by 35%; CaAc did not change T50. In Stage 3 CKD, neither EffCaMgCit nor CaAc altered T50. With EffCaMgCit, a significant increase in plasma citrate was accompanied by statistically non-significant increase in serum Mg and phosphate. CaAc was without effect in any of these parameters in Stage 3 CKD. In both Stages 3 and 5D, both drugs significantly reduced serum parathyroid hormone. Only EffCaMgCit significantly increased serum bicarbonate by 3 mM (P = 0.015) in Stage 5D.
CONCLUSIONS


In Stage 5D, EffCaMgCit inhibited formation of CPP, suppressed PTH, and conferred magnesium and alkali loads. These effects were unique, since they were not observed with CaAc. In Stage 3 CKD, neither of the regimens have any effect. These metabolic changes suggest that EffCaMgCit might be useful in protecting against cardiovascular complications of CKD by ameliorating pathobiologic intermediates.",2019,"Only EffCaMgCit significantly increased serum bicarbonate by 3 mM (P = 0.015) in Stage 5D.
CONCLUSIONS


","['Nine patients with Stage 3 and nine patients with Stage 5D CKD', 'chronic kidney disease (CKD']","['effervescent calcium magnesium citrate', 'conventional phosphorus binder calcium acetate (CaAc', 'effervescent calcium magnesium citrate (EffCaMgCit']","['serum parathyroid hormone', 'plasma citrate', 'serum Mg and phosphate', 'serum phosphorus', 'serum bicarbonate', 'EffCaMgCit nor CaAc altered T50']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0126774', 'cui_str': 'magnesium citrate'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0717537', 'cui_str': 'calcium acetate'}, {'cui': 'C0642815', 'cui_str': 'CAAC'}]","[{'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376259', 'cui_str': 'Citrate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0642815', 'cui_str': 'CAAC'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",9.0,0.040943,"Only EffCaMgCit significantly increased serum bicarbonate by 3 mM (P = 0.015) in Stage 5D.
CONCLUSIONS


","[{'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Quiñones', 'Affiliation': 'Divisions of Nephrology, University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. henry.quinones@utsouthwestern.edu.'}, {'ForeName': 'Tamim', 'Initials': 'T', 'LastName': 'Hamdi', 'Affiliation': 'Divisions of Nephrology, University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Sakhaee', 'Affiliation': 'Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pasch', 'Affiliation': 'Calciscon, Nidau-Biel, Switzerland.'}, {'ForeName': 'Orson W', 'Initials': 'OW', 'LastName': 'Moe', 'Affiliation': 'Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Charles Y C', 'Initials': 'CYC', 'LastName': 'Pak', 'Affiliation': 'Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Journal of nephrology,['10.1007/s40620-018-0559-2']
54,30708069,Do clowns attenuate pain and anxiety undergoing botulinum toxin injections in children?,"OBJECTIVE


Botulinum toxin injection (BTI) is the primary treatment for spasticity in children. Anxiety and pain are important concerns to address to attenuate the discomfort of BTI. The aim of this study was to compare the effectiveness of medical clowns and usual distractions, both added to nitrous oxide (N 2 O) and analgesic cream, on pain and anxiety during BTI sessions in children.
METHODS


The primary outcome was pain evaluated by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Secondary criteria were pain rated on a Visual Analog Scale (VAS) by the child and parent, anxiety rated on a VAS before and during BTIs by the child and parent(s), rating of the success of the sessions on a 4-point Likert scale by the physician and parent(s), and rating of the benefits of the distraction by the parent(s). Non-parametric tests were used for between-group comparisons.
RESULTS


Baseline group characteristics of the clown and control groups did not differ. During 88 BTI sessions (40 with clown distraction and 48 with control distraction) in 59 children (35 boys; 52 with cerebral palsy, 12 with moderate to severe cognitive disorders), median maximal FLACC score was 2.5 (interquartile range [IQR]: 1-4) in the clown group and 3 (IQR: 1-4.3) in the control group. VAS self-reported pain score was 2.5 (IQR: 0-5) and 3 (IQR: 1-6.3) in the clown and control groups (P=0.56), and VAS proxy-reported pain score was 2.5 (IQR: 0.3-3.4) and 3 (IQR: 1-4.5) (P=0.25). After BTI sessions, the 2 groups did not differ in VAS self- and proxy-reported anxiety (P=0.83 and P=0.81). Physician and parent ratings of the success of sessions were similar between the groups (P=0.89 and P=0.11). Parent ratings of the perceived benefits of distraction were higher in the clown than control group (P=0.004).
CONCLUSIONS


Although clown distraction was particularly appreciated by parents, it did not significantly reduce pain or anxiety in children as compared with usual distraction.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03149263.",2020,"Parent ratings of the perceived benefits of distraction were higher in the clown than control group (P=0.004).
","['children', '59 children (35 boys; 52 with cerebral palsy, 12 with moderate to severe cognitive disorders', 'spasticity in children']","['Botulinum toxin injection (BTI', 'botulinum toxin injections', 'medical clowns and usual distractions, both added to nitrous oxide (N 2 O) and analgesic cream']","['Anxiety and pain', 'pain evaluated by the Face, Legs, Activity, Cry, Consolability (FLACC) scale', 'pain or anxiety', 'pain rated on a Visual Analog Scale (VAS) by the child and parent, anxiety rated on a VAS before and during BTIs by the child and parent(s), rating of the success of the sessions on a 4-point Likert scale by the physician and parent(s), and rating of the benefits of the distraction by the parent(s). Non-parametric tests', 'VAS proxy-reported pain score', 'Parent ratings of the perceived benefits of distraction', 'median maximal FLACC score', 'VAS self-reported pain score', 'pain and anxiety', 'VAS self- and proxy-reported anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0009241', 'cui_str': 'Cognition Disorders'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}]","[{'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0335094', 'cui_str': 'Clown (occupation)'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",59.0,0.0642645,"Parent ratings of the perceived benefits of distraction were higher in the clown than control group (P=0.004).
","[{'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Houx', 'Affiliation': 'Department of physical and medical rehabilitation, CHRU MORVAN, 29602 Brest, Bretagne, France; Department of pediatric physical and medical rehabilitation, fondation ILDYS, 29200 Brest, Bretagne, France; Laboratory of medical information processing, Inserm U1101, 29200 Brest, Bretagne, France. Electronic address: laetitia.houx@chu-brest.fr.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Dubois', 'Affiliation': 'Department of psychology, university of occidental Brittany, 29200 Brest, Bretagne, France; LP3C, EA 1285, Rennes 2, 35000 Rennes, Bretagne, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Brochard', 'Affiliation': 'Department of physical and medical rehabilitation, CHRU MORVAN, 29602 Brest, Bretagne, France; Department of pediatric physical and medical rehabilitation, fondation ILDYS, 29200 Brest, Bretagne, France; Laboratory of medical information processing, Inserm U1101, 29200 Brest, Bretagne, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Pons', 'Affiliation': 'Department of pediatric physical and medical rehabilitation, fondation ILDYS, 29200 Brest, Bretagne, France; Laboratory of medical information processing, Inserm U1101, 29200 Brest, Bretagne, France.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2018.12.004']
55,29242108,"A multi-level intervention in worksites to increase fruit and vegetable access and intake: Rationale, design and methods of the 'Good to Go' cluster randomized trial.","BACKGROUND


Fruit and vegetable (F&V) consumption is an important contributor to chronic disease prevention. However, most Americans do not eat adequate amounts. The worksite is an advantageous setting to reach large, diverse segments of the population with interventions to increase F&V intake, but research gaps exist. No studies have evaluated the implementation of mobile F&V markets at worksites nor compared the effectiveness of such markets with or without nutrition education.
METHODS


This paper describes the protocol for Good to Go (GTG), a cluster randomized trial to evaluate F&V intake change in employees from worksites randomized into three experimental arms: discount, fresh F&V markets (Access Only arm); markets plus educational components including campaigns, cooking demonstrations, videos, newsletters, and a web site (Access Plus arm); and an attention placebo comparison intervention on physical activity and stress reduction (Comparison). Secondary aims include: 1) Process evaluation to determine costs, reach, fidelity, and dose as well as the relationship of these variables with changes in F&V intake; 2) Applying a mediating variable framework to examine relationships of psychosocial factors/determinants with changes in F&V consumption; and 3) Cost effectiveness analysis of the different intervention arms.
DISCUSSION


The GTG study will fill important research gaps in the field by implementing a rigorous cluster randomized trial to evaluate the efficacy of an innovative environmental intervention providing access and availability to F&V at the worksite and whether this access intervention is further enhanced by accompanying educational interventions. GTG will provide an important contribution to public health research and practice. Trial registration number NCT02729675, ClinicalTrials.gov.",2018,"The worksite is an advantageous setting to reach large, diverse segments of the population with interventions to increase F&V intake, but research gaps exist.",[],"['discount, fresh F&V markets (Access Only arm); markets plus educational components including campaigns, cooking demonstrations, videos, newsletters, and a web site (Access Plus arm); and an attention placebo comparison intervention', 'Fruit and vegetable']","['1) Process evaluation to determine costs, reach, fidelity, and dose as well as the relationship of these variables with changes in F&V intake; 2) Applying a mediating variable framework to examine relationships of psychosocial factors/determinants with changes in F&V consumption; and 3) Cost effectiveness analysis']",[],"[{'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]","[{'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}]",,0.0833753,"The worksite is an advantageous setting to reach large, diverse segments of the population with interventions to increase F&V intake, but research gaps exist.","[{'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Risica', 'Affiliation': 'Center for Health Equity Research, Brown School of Public Health, Providence, RI 02912, USA; Department of Behavioral and Social Sciences, Brown School of Public Health, Providence, RI 02912, USA; Department of Epidemiology, Brown School of Public Health, Providence, RI 02912, USA. Electronic address: patricia_risica@brown.edu.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Gorham', 'Affiliation': 'Center for Health Equity Research, Brown School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dionne', 'Affiliation': 'Center for Health Equity Research, Brown School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Nardi', 'Affiliation': 'Center for Health Equity Research, Brown School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Ng', 'Affiliation': 'Currently with Department of Surgery, Columbia University Medical Center, NY, New York 10032, USA.'}, {'ForeName': 'Reese', 'Initials': 'R', 'LastName': 'Middler', 'Affiliation': 'Center for Health Equity Research, Brown School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mello', 'Affiliation': 'Center for Health Equity Research, Brown School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'Rahmet', 'Initials': 'R', 'LastName': 'Akpolat', 'Affiliation': 'Department of Human Development and Family Studies, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Gettens', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Center for Health Equity Research, Brown School of Public Health, Providence, RI 02912, USA; Department of Behavioral and Social Sciences, Brown School of Public Health, Providence, RI 02912, USA; Department of Human Development and Family Studies, University of Connecticut, Storrs, CT 06269, USA; Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs, CT 06269, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2017.12.002']
56,29510223,"Using Facebook to address smoking and heavy drinking in young adults: Protocol for a randomized, controlled trial.","INTRODUCTION


Tobacco and alcohol often are used simultaneously by young adults, and their co-use is associated with greater health consequences than from single use. Social media platforms offer low cost and highly accessible channels to reach and engage young people in substance use interventions. The current trial seeks to compare the Facebook Tobacco Status Project (TSP) smoking cessation intervention to an intervention targeting both tobacco use and heavy episodic drinking (TSP + ALC) among young adults who use both substances.
METHODS


This randomized clinical trial will evaluate the feasibility and initial efficacy of TSP + ALC compared to TSP with 225 US young adult smokers reporting heavy drinking. Participants will be recruited online and randomized to one of two conditions (TSP or TSP + ALC), both with assignment to a Facebook group tailored to readiness to quit smoking. Groups will receive a 90-day intervention including daily Facebook postings and weekly live counseling sessions. The TSP + ALC group will include content related to alcohol use. All participants will be offered a 2-week introductory supply of nicotine patch. Participants will complete baseline, 3-, 6-, and 12-month online assessments of substance use and other health risk behaviors. The primary efficacy outcome is biochemically-verified 7-day point prevalence abstinence. Secondary outcomes include alcohol and tobacco use, combined use, and thoughts about each substance.
DISCUSSION


This trial examines an innovative and scalable approach to engaging young adults online in tobacco and alcohol use treatment. Study findings will inform digital health interventions and best practices for treating multiple substance use in young adults.",2018,"Participants will be recruited online and randomized to one of two conditions (TSP or TSP + ALC), both with assignment to a Facebook group tailored to readiness to quit smoking.","['young adults who use both substances', 'young adults', '225 US young adult smokers reporting heavy drinking']","['tobacco use and heavy episodic drinking (TSP\u202f+\u202fALC', 'Facebook group tailored to readiness to quit smoking', 'TSP\u202f+\u202fALC', 'nicotine patch', 'Facebook Tobacco Status Project (TSP) smoking cessation intervention', 'Facebook', 'conditions (TSP or TSP\u202f+\u202fALC', '90-day intervention including daily Facebook postings and weekly live counseling sessions', 'TSP']","['biochemically-verified 7-day point prevalence abstinence', 'alcohol and tobacco use, combined use, and thoughts about each substance']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]","[{'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}]",,0.0512471,"Participants will be recruited online and randomized to one of two conditions (TSP or TSP + ALC), both with assignment to a Facebook group tailored to readiness to quit smoking.","[{'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States. Electronic address: danielle.ramo@ucsf.edu.'}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Ella S', 'Initials': 'ES', 'LastName': 'Corpuz', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology and Psychiatry, University of California, San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.02.014']
57,31201082,"Re: Arinobu Fukunaga, Takahisa Kawaguchi, Satoshi Funada, et al. Sleep Disturbance Worsens Lower Urinary Tract Symptoms (LUTS): The Nagahama Study. J Urol. In press. https://doi.org/10.1097/JU.0000000000000212: Relationship between sleep disturbance and low urinary tract symptoms: ""Shallow Medicine"".",,2021,,['Sleep Disturbance Worsens Lower Urinary Tract Symptoms (LUTS'],[],[],"[{'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}]",[],[],,0.0154617,,"[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Misraï', 'Affiliation': 'Department of Urology, Clinique Pasteur, Toulouse, France. Electronic address: v.misrai@clinique-pasteur.com.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Charbonneau', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Department of Cardiology, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Louvrier', 'Affiliation': 'Department of Otorhinolaryngology, Clinique Ambroise Paré, Toulouse, France.'}, {'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': 'Maldent', 'Affiliation': 'Department of Otorhinolaryngology, Clinique Ambroise Paré, Toulouse, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Milioto', 'Affiliation': 'Department of Nephrology, Clinique Saint Exupéry, Toulouse, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Attias', 'Affiliation': 'Department of Pneumology, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Aranda', 'Affiliation': ""Department of Neurology and Sleep diseases, Clinique de l'Union, Toulouse, France.""}]",European urology focus,['10.1016/j.euf.2019.05.018']
58,25376639,Racial differences in abnormal ambulatory blood pressure monitoring measures: Results from the Coronary Artery Risk Development in Young Adults (CARDIA) study.,"BACKGROUND


Several ambulatory blood pressure monitoring (ABPM) measures have been associated with increased cardiovascular disease risk independent of clinic blood pressure (BP). African Americans have higher clinic BP compared with Whites but few data are available on racial differences in ABPM measures.
METHODS


We compared ABPM measures between African American (n = 178) and White (n = 103) participants at the Year 5 Coronary Artery Risk Development in Young Adults study visit. BP was measured during a study visit and the second and third measurements were averaged. ABPM was conducted over the following 24 hours.
RESULTS


Mean ± SD age of participants was 29.8 ± 3.8 years and 30.8 ± 3.5 years for African Americans and Whites, respectively. Mean daytime systolic BP (SBP) was 3.90 (SD 1.18) mm Hg higher among African Americans compared with Whites (P < 0.001) after age-gender adjustment and 1.71 (SD 1.03) mm Hg higher after multivariable adjustment including mean clinic SBP (P = 0.10). After multivariable adjustment including mean clinic SBP, nighttime SBP was 4.83 (SD 1.11) mm Hg higher among African Americans compared with Whites (P < 0.001). After multivariable adjustment, the African Americans were more likely than Whites to have nocturnal hypertension (prevalence ratio: 2.44, 95% CI: 0.99-6.05) and nondipping (prevalence ratio: 2.50, 95% CI: 1.39-4.48). The prevalence of masked hypertension among African Americans and Whites was 4.4% and 2.1%, respectively, (P = 0.49) and white coat hypertension was 3.3% and 3.9%, respectively (P = 0.99). Twenty-four hour BP variability on ABPM was higher among African Americans compared with Whites.
CONCLUSIONS


These data suggest racial differences in several ABPM measures exist.",2015,"After multivariable adjustment, the African Americans were more likely than Whites to have nocturnal hypertension (prevalence ratio: 2.44, 95% CI: 0.99-6.05) and nondipping (prevalence ratio: 2.50, 95% CI: 1.39-4.48).","['African Americans', 'Young Adults (CARDIA) study', 'Mean ± SD age of participants was 29.8 ± 3.8 years and 30.8 ± 3.5 years for African Americans and Whites, respectively', 'African American (n = 178) and White (n = 103) participants at the Year 5 Coronary Artery Risk Development in Young Adults study visit']",[],"['white coat hypertension', 'ABPM', 'Mean daytime systolic BP (SBP', 'mean clinic SBP, nighttime SBP', 'BP variability on ABPM', 'BP', 'clinic BP', 'nocturnal hypertension', 'clinic blood pressure (BP', 'mean clinic SBP']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243107', 'cui_str': 'development'}]",[],"[{'cui': 'C0262534', 'cui_str': 'White Coat Syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",103.0,0.0484473,"After multivariable adjustment, the African Americans were more likely than Whites to have nocturnal hypertension (prevalence ratio: 2.44, 95% CI: 0.99-6.05) and nondipping (prevalence ratio: 2.50, 95% CI: 1.39-4.48).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA; pmuntner@uab.edu.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA;'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Diaz', 'Affiliation': 'Department of Medicine, Columbia University, New York, New York, USA;'}, {'ForeName': 'April P', 'Initials': 'AP', 'LastName': 'Carson', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA;'}, {'ForeName': 'Yongin', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA;'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Calhoun', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA;'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yano', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, Illinois, USA;'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Viera', 'Affiliation': 'Department of Family Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Department of Medicine, Columbia University, New York, New York, USA;'}]",American journal of hypertension,['10.1093/ajh/hpu193']
59,31718393,Do Violence Acceptance and Bystander Actions Explain the Effects of Green Dot on Reducing Violence Perpetration in High Schools?,"This study extends prior analyses from a 5-year multisite cluster-randomized controlled trial to examine how the previously reported effects of the Green Dot bystander-based prevention program worked to reduce violence perpetration. Bystander-based interventions are hypothesized to prevent violence by reducing violence acceptance and increasing trained participants' willingness and ability to actively engage others in violence prevention using safe and effective bystander actions to diffuse or avoid potentially violent situations. We tested this hypothesis by examining whether Green Dot worked to reduce violence through two mediators measured over time: reducing violence acceptance and increasing bystander actions. When accounting for changes in these mediators over time, the effect of this intervention on violence perpetration was hypothesized to be attenuated or explained. At baseline (spring 2010) and annually (2011-2014), all students in recruited high schools (13 intervention, 13 control) completed an anonymous survey (response rate = 83.9%). Student responses were aggregated as school-level counts for the analysis. Path analyses estimated direct and indirect effects at specific points in the implementation of the intervention. Longitudinal models were used to determine if changes in violence acceptance and bystander actions could explain or attenuate the effect of the intervention. Time-framed path model analyses indicated that the intervention worked as expected to increase bystander behaviors and reduce violence acceptance; both potential mediators were significantly associated with sexual violence perpetration. In addition, after adjusting intent-to-treat models for the hypothesized mediators, the intervention was no longer associated with violence perpetration. In conclusion, these findings indicate that this bystander intervention worked as hypothesized to reduce sexual violence perpetration by creating theory-based changes in students' violence acceptance and bystander actions.",2021,Time-framed path model analyses indicated that the intervention worked as expected to increase bystander behaviors and reduce violence acceptance; both potential mediators were significantly associated with sexual violence perpetration.,"['At baseline (spring 2010) and annually (2011-2014), all students in recruited high schools (13 intervention, 13 control) completed an anonymous survey (response rate = 83.9']","['Green Dot bystander-based prevention program', 'Green Dot']","['sexual violence perpetration', 'bystander behaviors and reduce violence acceptance', 'violence acceptance and increasing bystander actions']","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",,0.0240952,Time-framed path model analyses indicated that the intervention worked as expected to increase bystander behaviors and reduce violence acceptance; both potential mediators were significantly associated with sexual violence perpetration.,"[{'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bush', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Coker', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'DeGue', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Clear', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Candace J', 'Initials': 'CJ', 'LastName': 'Brancato', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Bonnie S', 'Initials': 'BS', 'LastName': 'Fisher', 'Affiliation': 'University of Cincinnati, OH, USA.'}]",Journal of interpersonal violence,['10.1177/0886260519888206']
60,30958058,Effects of External Counterpulsation on Postexercise Recovery in Elite Rugby League Players.,"PURPOSE


External counterpulsation (ECP) has previously been used to treat cardiac patients via compression of the lower extremities during diastole to increase venous return and coronary perfusion. However, the effects of ECP on exercise performance and markers of recovery in elite athletes are largely unknown.
METHODS


On 2 separate occasions, 48 h apart, 7 elite National Rugby League players performed an identical 60-min field-based conditioning session followed by a 30-min period of either regular ECP treatment or placebo. Power measures during repeated cycle bouts and countermovement jump height and contraction time derivatives were measured at rest and 5 h postexercise. Saliva samples and venous blood samples were taken at rest, postexercise, and 5 h postexercise to assess stress, inflammation, and muscle damage.
RESULTS


After ECP treatment, cycling peak power output (P = .028; 11%) and accumulated peak power (P = .027; 14%) increased compared with the placebo condition. Postexercise plasma interleukin 1 receptor antagonist only increased after ECP (P = .024; 84%), and concentrations of plasma interleukin 1 receptor antagonist tended to be higher (P = .093; 76%) 5 h postexercise. Furthermore, testosterone-to-cortisol ratio was increased above baseline and placebo 5 h postexercise (P = .017-.029; 24-77%). The ratio of postexercise salivary α-amylase to immunoglobulin A decreased after treatment (P = .013; 50%) compared with the placebo control.
CONCLUSIONS


Exercise performance and hormonal indicators of stress were improved and inflammation markers were reduced following acute ECP.",2019,"Post-exercise salivary alpha amylase to Immunoglobulin A ratio decreased after treatment (p=0.013; 50%), compared with the placebo control.
","['Elite League Players', 'elite athletes']","['ECP treatment or placebo', 'External counterpulsation (ECP', 'external Counterpulsation', 'ECP']","['countermovement jump height and contraction time derivatives', 'stress, inflammation and muscle damage', 'exercise performance and markers of recovery', 'Post-exercise salivary alpha amylase to Immunoglobulin A ratio', 'Post-exercise plasma Interleukin 1 receptor (IL-1ra', 'Saliva samples and venous blood samples', 'accumulated peak power', 'Furthermore, testosterone to cortisol ratio', 'cycling peak power output', 'concentrations of IL-1ra']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010217', 'cui_str': 'Counterpulsation, External'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0063710', 'cui_str': 'Receptors, IL-1'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.412821,"Post-exercise salivary alpha amylase to Immunoglobulin A ratio decreased after treatment (p=0.013; 50%), compared with the placebo control.
","[{'ForeName': 'Llion A', 'Initials': 'LA', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'Johnpaul', 'Initials': 'J', 'LastName': 'Caia', 'Affiliation': ''}, {'ForeName': 'Lachlan P', 'Initials': 'LP', 'LastName': 'James', 'Affiliation': ''}, {'ForeName': 'Tannath J', 'Initials': 'TJ', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'Vincent G', 'Initials': 'VG', 'LastName': 'Kelly', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2018-0682']
61,30958062,"Acute Enhancement of Jump Performance, Muscle Strength, and Power in Resistance-Trained Men After Consumption of Caffeinated Chewing Gum.","PURPOSE


To explore the acute effects of caffeinated chewing gum on vertical-jump performance, isokinetic knee-extension/flexion strength and power, barbell velocity in resistance exercise, and whole-body power.
METHODS


Nineteen resistance-trained men consumed, in randomized counterbalanced order, either caffeinated chewing gum (300 mg of caffeine) or placebo and completed exercise testing that included squat jump; countermovement jump; isokinetic knee extension and knee flexion at angular velocities of 60 and 180°·s-1; bench-press exercise with loads corresponding to 50%, 75%, and 90% of 1-repetition maximum (1RM); and an ""all-out"" rowing-ergometer test.
RESULTS


Compared with placebo, caffeinated chewing gum enhanced (all Ps < .05) (1) vertical-jump height in the squat jump (effect size [ES] = 0.21; +3.7%) and countermovement jump (ES = 0.27; +4.6%); (2) knee-extension peak torque (ES = 0.21; +3.6%) and average power (ES = 0.25; +4.5%) at 60°·s-1 and knee-extension average power (ES = 0.30; +5.2%) at 180°·s-1, and knee-flexion peak torque at 60°·s-1 (ES = 0.22; +4.1%) and 180°·s-1 (ES = 0.31; +5.9%); (3) barbell velocity at 50% of 1RM (ES = 0.30; +3.2%), 75% of 1RM (ES = 0.44; +5.7%), and 90% of 1RM (ES = 0.43; +9.1%); and (4) whole-body peak power on the rowing-ergometer test (ES = 0.41; +5.0%). Average power of the knee flexors did not change at either angular velocity with caffeine consumption.
CONCLUSIONS


Caffeinated chewing gum with a dose of caffeine of 300 mg consumed 10 min preexercise may acutely enhance vertical-jump height, isokinetic strength and power of the lower-body musculature, barbell velocity in the bench-press exercise with moderate to high loads, and whole-body power.",2019,"Compared to placebo, caffeinated chewing gum enhanced (all P<0.05): (1) vertical jump height in the SJ (effect size [ES]=0.21; +3.7%) and CMJ (ES=0.27; +4.6%); (2) knee extension peak torque (ES=0.21; +3.6%) and average power (ES=0.25; +4.5%) at 60°·s -1  and knee extension average power (ES=0.30; +5.2%) at 180°·s -1 ; knee flexion peak torque at 60°·s -1  (ES=0.22; +4.1%) and 180°·s -1  (ES=0.31; +5.9%); (3) barbell velocity at 50% of 1RM (ES=0.30; +3.2%), 75% of 1RM (ES=0.44; +5.7%), and 90% of 1RM (ES=0.43; +9.1%); and (4) whole-body peak power on the rowing-ergometer test (ES=0.41; +5.0%).",['Nineteen resistance-trained men'],"['caffeinated chewing gum', 'placebo', 'caffeinated chewing gum (300 mg of caffeine) or placebo, and completed exercise testing that included squat jump (SJ), countermovement jump (CMJ), isokinetic knee extension and knee flexion at angular velocities of 60°·s -1  and 180°·s', 'Caffeinated Chewing Gum', 'all-out"" rowing-ergometer test']","['knee flexion peak torque', 'Acute Enhancement of Jump Performance, Muscle Strength, and Power in Resistance-Trained Men', ' (1) vertical jump performance; (2) isokinetic knee extension/flexion strength and power; (3) barbell velocity in resistance exercise', 'knee extension peak torque']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4321298', 'cui_str': 'Chewing gum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0518308,"Compared to placebo, caffeinated chewing gum enhanced (all P<0.05): (1) vertical jump height in the SJ (effect size [ES]=0.21; +3.7%) and CMJ (ES=0.27; +4.6%); (2) knee extension peak torque (ES=0.21; +3.6%) and average power (ES=0.25; +4.5%) at 60°·s -1  and knee extension average power (ES=0.30; +5.2%) at 180°·s -1 ; knee flexion peak torque at 60°·s -1  (ES=0.22; +4.1%) and 180°·s -1  (ES=0.31; +5.9%); (3) barbell velocity at 50% of 1RM (ES=0.30; +3.2%), 75% of 1RM (ES=0.44; +5.7%), and 90% of 1RM (ES=0.43; +9.1%); and (4) whole-body peak power on the rowing-ergometer test (ES=0.41; +5.0%).","[{'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Venier', 'Affiliation': ''}, {'ForeName': 'Jozo', 'Initials': 'J', 'LastName': 'Grgic', 'Affiliation': ''}, {'ForeName': 'Pavle', 'Initials': 'P', 'LastName': 'Mikulic', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0098']
62,30661507,The effect of a lifestyle intervention in obese pregnant women on gestational metabolic profiles: findings from the UK Pregnancies Better Eating and Activity Trial (UPBEAT) randomised controlled trial.,"BACKGROUND


Pregnancy is associated with widespread change in metabolism, which may be more marked in obese women. Whether lifestyle interventions in obese pregnant women improve pregnancy metabolic profiles remains unknown. Our objectives were to determine the magnitude of change in metabolic measures during obese pregnancy, to indirectly compare these to similar profiles in a general pregnant population, and to determine the impact of a lifestyle intervention on change in metabolic measures in obese pregnant women.
METHODS


Data from a randomised controlled trial of 1158 obese (BMI ≥ 30 kg/m 2 ) pregnant women recruited from six UK inner-city obstetric departments were used. Women were randomised to either the UPBEAT intervention, a tailored complex lifestyle intervention focused on improving diet and physical activity, or standard antenatal care (control group). UPBEAT has been shown to improve diet and physical activity during pregnancy and up to 6-months postnatally in obese women and to reduce offspring adiposity at 6-months; it did not affect risk of gestational diabetes (the primary outcome). Change in the concentrations of 158 metabolic measures (129 lipids, 9 glycerides and phospholipids, and 20 low-molecular weight metabolites), quantified three times during pregnancy, were compared using multilevel models. The role of chance was assessed with a false discovery rate of 5% adjusted p values.
RESULTS


All very low-density lipoprotein (VLDL) particles increased by 1.5-3 standard deviation units (SD) whereas intermediate density lipoprotein and specific (large, medium and small) LDL particles increased by 1-2 SD, between 16 and 36 weeks' gestation. Triglycerides increased by 2-3 SD, with more modest changes in other metabolites. Indirect comparisons suggest that the magnitudes of change across pregnancy in these obese women were 2- to 3-fold larger than in unselected women (n = 4260 in cross-sectional and 583 in longitudinal analyses) from an independent, previously published, study. The intervention reduced the rate of increase in extremely large, very large, large and medium VLDL particles, particularly those containing triglycerides.
CONCLUSION


There are marked changes in lipids and lipoproteins and more modest changes in other metabolites across pregnancy in obese women, with some evidence that this is more marked than in unselected pregnant women. The UPBEAT lifestyle intervention may contribute to a healthier metabolic profile in obese pregnant women, but our results require replication.
TRIAL REGISTRATION


UPBEAT was registered with Current Controlled Trials, ISRCTN89971375 , on July 23, 2008 (prior to recruitment).",2019,"The intervention reduced the rate of increase in extremely large, very large, large and medium VLDL particles, particularly those containing triglycerides.
","['obese women', 'obese pregnant women', '1158 obese (BMI ≥\u200930 kg/m 2 ) pregnant women recruited from six UK inner-city obstetric departments were used', 'obese pregnant women on gestational metabolic profiles', 'unselected pregnant women']","['lifestyle interventions', 'lifestyle intervention', 'UPBEAT intervention, a tailored complex lifestyle intervention focused on improving diet and physical activity, or standard antenatal care (control group']","['low-density lipoprotein (VLDL) particles', 'Triglycerides', 'pregnancy metabolic profiles', 'rate of increase in extremely large, very large, large and medium VLDL particles', 'lipids and lipoproteins', 'intermediate density lipoprotein and specific (large, medium and small) LDL particles', 'false discovery rate']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0028775', 'cui_str': 'Obstetrics Department'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0065063', 'cui_str': 'Lipoproteins, Intermediate Density'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}]",1158.0,0.211281,"The intervention reduced the rate of increase in extremely large, very large, large and medium VLDL particles, particularly those containing triglycerides.
","[{'ForeName': 'Harriet L', 'Initials': 'HL', 'LastName': 'Mills', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK.'}, {'ForeName': 'Nashita', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': ""Division of Women's Health, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'White', 'Affiliation': ""Division of Women's Health, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Dharmintra', 'Initials': 'D', 'LastName': 'Pasupathy', 'Affiliation': ""Division of Women's Health, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Briley', 'Affiliation': ""Division of Women's Health, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Santos Ferreira', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Division of Women's Health, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Nelson', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Tilling', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Division of Women's Health, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Lawlor', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK. d.a.lawlor@bristol.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC medicine,['10.1186/s12916-018-1248-7']
63,31313123,A simple risk score for prediction of sepsis associated-acute kidney injury in critically ill patients.,"BACKGROUND


Sepsis is common and frequently fatal condition in critically ill patients and is a major cause of acute kidney injury (AKI). In this retrospective study, we sought to develop a comprehensive risk score model of sepsis associated-AKI (SA-AKI).
METHODS


A total of 2617 patients were randomly assigned to a development (1554 patients) and a validation group (777 patients). The risk score model for SA-AKI was developed with multivariate regression analysis in development group and the model was further evaluated on validation group.
RESULTS


We identified 16 independent predictors of SA-AKI in development group (age ≥ 60 years, hypertension/coronary heart disease, diabetes, chronic kidney disease, heart failure, chronic obstructive pulmonary disease, acute severe pancreatitis, hypotension, hypoproteinemia, lactic acidosis, the length of stay in intensive care unit(ICU), 60 g/L<hemoglobin < 90 g/L, hemoglobin ≤ 60 g/L, and ≥ 2 failed organs. This model had excellent performance characteristics in validation cohort(c statistic 0.857, 95% CI 0.839-0.874).
CONCLUSION


The novel risk score model for SA-AKI in ICU can identify patients at high risk to develop AKI. Application of this model could help clinicians to stratify patients for primary prevention, surveillance and early therapeutic intervention to improve care and prognosis of sepsis patients in ICU.",2019,"This model had excellent performance characteristics in validation cohort(c statistic 0.857, 95% CI 0.839-0.874).
","['60\xa0years, hypertension/coronary heart disease, diabetes, chronic kidney disease, heart failure, chronic obstructive pulmonary disease, acute severe pancreatitis, hypotension, hypoproteinemia, lactic acidosis, the length of stay in intensive care unit(ICU), 60\xa0g/L<hemoglobin\u2009<\u200990\xa0g/L, hemoglobin', 'sepsis patients in ICU', '2617 patients were randomly assigned to a development (1554 patients) and a validation group (777 patients', 'critically ill patients']",[],[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0020639', 'cui_str': 'Hypoproteinemia'}, {'cui': 'C1869036', 'cui_str': 'Lactic acidosis (SMQ)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]",[],[],2617.0,0.0635966,"This model had excellent performance characteristics in validation cohort(c statistic 0.857, 95% CI 0.839-0.874).
","[{'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Division of Ultrasound, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Division of Nephrology, Nanchong Central Hospital, Nanchong, 637000, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Dingming', 'Initials': 'D', 'LastName': 'Cai', 'Affiliation': 'Division of Ultrasound, West China Hospital of Sichuan University, Chengdu, 610041, China. doccai@163.com.'}, {'ForeName': 'Lichuan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China. ylcgh@163.com.'}]",Journal of nephrology,['10.1007/s40620-019-00625-y']
64,31211782,Association of maternal circulating 25(OH)D and calcium with birth weight: A mendelian randomisation analysis.,"BACKGROUND


Systematic reviews of randomised controlled trials (RCTs) have suggested that maternal vitamin D (25[OH]D) and calcium supplementation increase birth weight. However, limitations of many trials were highlighted in the reviews. Our aim was to combine genetic and RCT data to estimate causal effects of these two maternal traits on offspring birth weight.
METHODS AND FINDINGS


We performed two-sample mendelian randomisation (MR) using genetic instrumental variables associated with 25(OH)D and calcium that had been identified in genome-wide association studies (GWAS; sample 1; N = 122,123 for 25[OH]D and N = 61,275 for calcium). Associations between these maternal genetic variants and offspring birth weight were calculated in the UK Biobank (UKB) (sample 2; N = 190,406). We used data on mother-child pairs from two United Kingdom birth cohorts (combined N = 5,223) in sensitivity analyses to check whether results were influenced by fetal genotype, which is correlated with the maternal genotype (r ≈ 0.5). Further sensitivity analyses to test the reliability of the results included MR-Egger, weighted-median estimator, 'leave-one-out', and multivariable MR analyses. We triangulated MR results with those from RCTs, in which we used randomisation to supplementation with vitamin D (24 RCTs, combined N = 5,276) and calcium (6 RCTs, combined N = 543) as an instrumental variable to determine the effects of 25(OH)D and calcium on birth weight. In the main MR analysis, there was no strong evidence of an effect of maternal 25(OH)D on birth weight (difference in mean birth weight -0.03 g [95% CI -2.48 to 2.42 g, p = 0.981] per 10% higher maternal 25[OH]D). The effect estimate was consistent across our MR sensitivity analyses. Instrumental variable analyses applied to RCTs suggested a weak positive causal effect (5.94 g [95% CI 2.15-9.73, p = 0.002] per 10% higher maternal 25[OH]D), but this result may be exaggerated because of risk of bias in the included RCTs. The main MR analysis for maternal calcium also suggested no strong evidence of an effect on birth weight (-20 g [95% CI -44 to 5 g, p = 0.116] per 1 SD higher maternal calcium level). Some sensitivity analyses suggested that the genetic instrument for calcium was associated with birth weight via exposures that are independent of calcium levels (horizontal pleiotropy). Application of instrumental variable analyses to RCTs suggested that calcium has a substantial effect on birth weight (178 g [95% CI 121-236 g, p = 1.43 × 10-9] per 1 SD higher maternal calcium level) that was not consistent with any of the MR results. However, the RCT instrumental variable estimate may have been exaggerated because of risk of bias in the included RCTs. Other study limitations include the low response rate of UK Biobank, which may bias MR estimates, and the lack of suitable data to test whether the effects of genetic instruments on maternal calcium levels during pregnancy were the same as those outside of pregnancy.
CONCLUSIONS


Our results suggest that maternal circulating 25(OH)D does not influence birth weight in otherwise healthy newborns. However, the effect of maternal circulating calcium on birth weight is unclear and requires further exploration with more research including RCT and/or MR analyses with more valid instruments.",2019,"In the main MR analysis, there was no strong evidence of an effect of maternal 25(OH)D on birth weight (difference in mean birth weight",['otherwise healthy newborns'],"['maternal vitamin D (25[OH]D) and calcium supplementation', 'vitamin D']","['mean birth weight', 'birth weight', 'maternal genetic variants and offspring birth weight', 'maternal calcium levels', 'maternal circulating 25(OH)D and calcium with birth weight']","[{'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth (finding)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement (procedure)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]",,0.195579,"In the main MR analysis, there was no strong evidence of an effect of maternal 25(OH)D on birth weight (difference in mean birth weight","[{'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Thompson', 'Affiliation': 'Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tyrrell', 'Affiliation': 'Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Maria-Carolina', 'Initials': 'MC', 'LastName': 'Borges', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Beaumont', 'Affiliation': 'Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Knight', 'Affiliation': 'Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Wood', 'Affiliation': 'Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Ring', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hattersley', 'Affiliation': 'Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Freathy', 'Affiliation': 'Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Debbie A', 'Initials': 'DA', 'LastName': 'Lawlor', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1002828']
65,30870252,"Patient-Centered Outcomes and Key Study Procedure Finalization in the Pilot Feasibility Gout Randomized Trial: Comparative Feasibility Study in GOUt, CHerry Extract Versus Diet Modification (Mini-GOUCH).","OBJECTIVE


The aim of this study was to report patient-centered outcomes and finalization of key study procedures from a 9-month pilot internet randomized controlled trial of cherry extract versus diet modification.
METHODS


We randomized 84 people with physician-confirmed gout in an internet study to cherry extract (n = 41) or dietitian-assisted diet modification for gout (n = 43). All study outcomes were collected via internet and phone calls. We finalized key study procedures. We assessed acceptability and feasibility of the intervention and satisfaction with study website.
RESULTS


Study participant satisfaction with the intervention was high. The intervention was perceived as easy, enjoyable, understandable, and helpful (scores 65-88 for all; higher = better). The amount of time spent for the study was acceptable. Participant satisfaction with website interaction and content was very high; 85% or more were moderately to extremely satisfied. Significantly lower total calories, total carbohydrate, and saturated fat intake were noted at 6 months in the diet modification versus cherry extract group; differences were insignificant at 9 months. Six of the 8 Health Assessment Questionnaire sections/domains improved significantly from baseline to 9 months in cherry extract versus 2 Health Assessment Questionnaire sections/domains in the diet modification group. Key study procedures were finalized for a future trial, including an internet diet assessment tool, gout flare assessment, provider confirmation of gout diagnosis, patient reporting of classification criteria, and centralized laboratory-assisted serum urate testing.
CONCLUSIONS


High patient acceptability and feasibility of study/intervention and finalization of key study procedures indicate that hypothesis-testing internet gout trials of cherry extract and/or diet modification can be conducted in the future.",2020,Six of the 8 Health Assessment Questionnaire sections/domains improved significantly from baseline to 9 months in cherry extract versus 2 Health Assessment Questionnaire sections/domains in the diet modification group.,['84 people with physician-confirmed gout in an internet study to cherry extract (n = 41) or dietitian-assisted diet modification for gout (n = 43'],"['cherry extract versus diet modification', 'GOUt, CHerry Extract Versus Diet Modification (Mini-GOUCH']","['total calories, total carbohydrate, and saturated fat intake']","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0330657', 'cui_str': 'Pie Cherry'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0086153', 'cui_str': 'Dietary Modification'}]","[{'cui': 'C0330657', 'cui_str': 'Pie Cherry'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0086153', 'cui_str': 'Dietary Modification'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0556120', 'cui_str': 'Saturated fat intake (observable entity)'}]",84.0,0.0403927,Six of the 8 Health Assessment Questionnaire sections/domains improved significantly from baseline to 9 months in cherry extract versus 2 Health Assessment Questionnaire sections/domains in the diet modification group.,"[{'ForeName': 'Jasvinder A', 'Initials': 'JA', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Willig', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine at School of Medicine.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Darnell', 'Affiliation': 'Departments of Nutrition, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Medicine at School of Medicine.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Morgan', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Medicine at School of Medicine.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Viocare, Princeton, NJ.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Medicine at School of Medicine.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Biostatistics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McGwin', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine at School of Medicine.'}]",Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases,['10.1097/RHU.0000000000001018']
66,30958066,"Effects of Caffeine on Exertion, Skill Performance, and Physicality in Ice Hockey.","PURPOSE


To determine the effects of low-dose caffeine supplementation (3 mg/kg body mass) consumed 1 h before the experiment on rating of perceived exertion (RPE), skills performance (SP), and physicality in male college ice hockey players.
METHODS


Using a double-blind, placebo-controlled, randomized crossover experimental design, 15 college ice hockey players participated in SP trials and 14 participated in scrimmage (SC) trials on a total of 4 d, with prescribed ice hockey tasks occurring after a 1-h high-intensity practice. In the SP trials, time to complete and error rate for each drill of the validated Western Hockey League Combines Testing Standard were recorded. Peak head accelerations, trunk contacts, and offensive performance were quantified during the SC trials using accelerometery and video analysis. RPE was assessed in both the SP and SC trials.
RESULTS


RPE was significantly greater in the caffeine (11.3 [2.0]) than placebo (9.9 [1.9]) condition postpractice (P = .002), with a trend toward greater RPE in caffeine (16.9 [1.8]) than placebo (15.7 [2.8]) post-SC (P = .05). There was a greater number of peak head accelerations in the caffeine (4.35 [0.24]) than placebo (4.14 [0.24]) condition (P = .028). Performance times, error rate, and RPE were not different between intervention conditions during the SP trials (P > .05).
CONCLUSIONS


A low dose of caffeine has limited impact on sport-specific skill performance and RPE but may enhance physicality during ice hockey SCs.",2019,"Performance times, error rate, and RPE were not different between intervention conditions during the skills performance trials (p>.050).
","['15 collegiate ice hockey players participated in skills performance trials and 14 participated in scrimmage trials on a total of four days, with prescribed ice hockey tasks occurring following a one-hour high-intensity practice', 'male collegiate ice hockey players']","['Caffeine', 'placebo', 'caffeine supplementation', 'caffeine']","['Exertion, Skill Performance and Physicality in Ice Hockey', 'time to complete and error rate', 'Performance times, error rate, and RPE', 'rating of perceived exertion (RPE), skills performance, and physicality', 'Peak head accelerations, trunk contacts and offensive performance', 'RPE', 'number of peak head accelerations']","[{'cui': 'C0020748', 'cui_str': 'Ice Hockey'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0020748', 'cui_str': 'Ice Hockey'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",15.0,0.330839,"Performance times, error rate, and RPE were not different between intervention conditions during the skills performance trials (p>.050).
","[{'ForeName': 'Robyn F', 'Initials': 'RF', 'LastName': 'Madden', 'Affiliation': ''}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Erdman', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Shearer', 'Affiliation': ''}, {'ForeName': 'Lawrence L', 'Initials': 'LL', 'LastName': 'Spriet', 'Affiliation': ''}, {'ForeName': 'Reed', 'Initials': 'R', 'LastName': 'Ferber', 'Affiliation': ''}, {'ForeName': 'Ash T', 'Initials': 'AT', 'LastName': 'Kolstad', 'Affiliation': ''}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Bigg', 'Affiliation': ''}, {'ForeName': 'Alexander S D', 'Initials': 'ASD', 'LastName': 'Gamble', 'Affiliation': ''}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Benson', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0130']
67,30958069,Improved Sprint Performance With Inhaled Long-Acting β2-Agonists Combined With Resistance Exercise.,"PURPOSE


To investigate the impact of twice-daily inhalation of 100 µg of salmeterol (SAL) or 12 µg of formoterol (FOR) in addition to a strength- and power-training program over a 5-wk period on a 30-m sprint, strength, power, mood, stress, and skinfold thickness.
METHODS


In a randomized, single-blind study, 23 male and 15 female nonasthmatic, recreationally active individuals were recruited (mean [SD] age 26.3 [5.4] y, weight 76.2 [11.5] kg, height 176.9 [8.5] cm). Participants completed 3 standardized whole-body strength- and power-training sessions per week for 5 wk during which they were assigned to an SAL, FOR, or placebo group. Participants used their inhaler twice per day as instructed and completed assessments of sprint, strength, and power at baseline and 1 wk after cessation of the training program. The assessments included a 30-m sprint, vertical jump, 1-repetition-maximum (1RM) bench press, 1RM leg press, peak torque flexion and extension, anthropometric evaluation, and Rest-Q questionnaires.
RESULTS


After 5 wk of strength and power training, 30-m sprint time reduced in the FOR (0.29 [0.11] s, P = .049) and SAL (0.35 [0.05] s, P = .040) groups compared with placebo (+0.01 [0.11] s). No significant change was found in other assessments of strength, mood, or skinfold thickness.
CONCLUSIONS


When strength and power training are combined with the inhalation of FOR or SAL over a 5-wk period, moderately trained individuals experience an improvement in 30-m sprint performance.",2019,"No significant change was found in other assessments of strength, mood, or skinfold thickness.
","['23 male and 15 female nonasthmatic, recreationally active individuals were recruited (mean ± SD age 26.3 ± 5.4 y, weight 76.2 ± 11.5 kg, height 176.9 ± 8.5 cm']","['salmeterol (SAL), formoterol (FOR), or placebo (PLA', 'salmeterol or 12 μg of formoterol', 'Agonists', 'Resistance Exercise']","['30-m sprint performance', 'strength, mood, or skinfold thickness', '30-m sprint, strength, power, mood, stress, and skinfold thickness', '30-m sprint, vertical jump, 1-repetition-maximum (1RM) bench press, 1RM leg press, peak torque flexion and extension, anthropometric evaluation, and Rest-Q questionnaires']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517668', 'cui_str': 'Twenty-six point three'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",23.0,0.130998,"No significant change was found in other assessments of strength, mood, or skinfold thickness.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Merlini', 'Affiliation': ''}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Whyte', 'Affiliation': ''}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Marcora', 'Affiliation': ''}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Loosemore', 'Affiliation': ''}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Chester', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dickinson', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2018-0921']
68,31709903,Post-Sexual Assault Mental Health: A Randomized Clinical Trial of a Video-Based Intervention.,"The current study assessed the efficacy of a brief video intervention (Prevention of Post-Rape Stress [PPRS]) delivered in the emergency department to recent sexual assault (SA) victims. PPRS was compared to treatment as usual (TAU) and an active control condition (Pleasant Imagery and Relaxation Instruction [PIRI]). Primary outcomes were posttraumatic stress disorder (PTSD) symptoms and perceived present control. Prior SA was examined as a moderator of treatment effects. Women ( n  = 233; aged 15 years and older; 59.70% identified as a racial or ethnic minority) who received a post-SA medical forensic exam participated in the study (NCT01430624). Participants were randomized to watch the PPRS video ( n  = 77), the PIRI video ( n  = 77), or receive TAU ( n  = 79). Participants completed measures of PTSD symptoms and perceived present control 1.5-, 3-, and 6-months post-SA. An interaction between condition and prior SA was found on PTSD symptom frequency and on perceived present control. Among women with a prior SA, women in the PPRS versus TAU condition reported less frequent PTSD symptoms 6-months post-SA. Those in the PPRS condition had lower perceived present control than those in the TAU condition among those with no prior SA 3-months post-SA. However, at 6-months post-SA, among women with a prior SA, women in the PPRS reported higher perceived present control than those in TAU. These findings partially replicate a prior study in which PPRS was found to be beneficial in mitigating the development of PTSD symptoms, but only for women with a prior SA.",2021,Those in the PPRS condition had lower perceived present control than those in the TAU condition among those with no prior SA 3-months post-SA.,"['emergency department to recent sexual assault (SA) victims', 'Women ( n  = 233; aged 15 years and older; 59.70% identified as a racial or ethnic minority) who received a post-SA medical forensic exam participated in the study (NCT01430624', 'Post-Sexual Assault Mental Health']","['TAU', 'Video-Based Intervention', 'PPRS video', 'PPRS', 'video intervention (Prevention of Post-Rape Stress [PPRS', 'PIRI video']","['posttraumatic stress disorder (PTSD) symptoms and perceived present control', 'PTSD symptom frequency', 'PTSD symptoms']","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0277730', 'cui_str': 'Victim of sexual aggression (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault (event)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency (observable entity)'}]",,0.018396,Those in the PPRS condition had lower perceived present control than those in the TAU condition among those with no prior SA 3-months post-SA.,"[{'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Gilmore', 'Affiliation': 'Georgia State University, Atlanta, GA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Walsh', 'Affiliation': 'Yeshiva University, New York, NY, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Frazier', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Meredith', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ledray', 'Affiliation': 'SANE-SART Resource Service, Minneapolis, MN, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'University of Tulsa, OK, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Ruggiero', 'Affiliation': 'Georgia State University, Atlanta, GA, USA.'}, {'ForeName': 'Dean G', 'Initials': 'DG', 'LastName': 'Kilpatrick', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Jaffe', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Resnick', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}]",Journal of interpersonal violence,['10.1177/0886260519884674']
69,20523820,Erratum: ERRATUM.,[This corrects the article on p. 217 in vol. 21.].,2009,[This corrects the article on p. 217 in vol. 21.].,[],[],[],[],[],[],,0.0149521,[This corrects the article on p. 217 in vol. 21.].,[],Annals of dermatology,['10.5021/ad.2009.21.3.335']
70,30588573,Effects of oral activated charcoal on hyperphosphatemia and vascular calcification in Chinese patients with stage 3-4 chronic kidney disease.,"BACKGROUND


The relationship between oral activated charcoal (OAC) and hyperphosphatemia and vascular calcification is not completely clear. We observed and recorded the effects of OAC on hyperphosphatemia and vascular calcification in stage 3-4 chronic kidney disease (CKD).
METHODS


In a randomized controlled study, we included 97 patients with stage 3-4 CKD. In the first phase of the experiment, the patients were randomly divided into the OAC group and placebo group. The endpoint of this phase was the development of hyperphosphatemia. The patients with hyperphosphatemia were selected into the second phase of the study. These patients underwent coronary artery multidetector computed tomography (MDCT) and were randomly divided into three groups: the OAC group, the calcium carbonate (CC) group and the lanthanum carbonate (LC) group.
RESULTS


The first and second phases of the experiment were followed for 12 months. In the first phase of the experiment, there was a statistically significant difference in the proportion of patients with hyperphosphatemia between the OAC and placebo groups (28.57% vs. 79.17%, X 2  = 24.958, P = 0.000). In the second phase, the differences in coronary calcification score (CACS) between the OAC group, the CC group and the LC group were statistically significant (525.5 ± 104.2 vs 688.1 ± 183.7 vs 431.4 ± 122.5, P < 0.01).
CONCLUSION


Oral activated charcoal effectively delays the onset of hyperphosphatemia in patients with chronic kidney disease. OAC appears to delay the development of vascular calcifications in stage 3-4 CKD patients.",2019,"In the first phase of the experiment, there was a statistically significant difference in the proportion of patients with hyperphosphatemia between the OAC and placebo groups (28.57% vs. 79.17%, X 2  = 24.958, P = 0.000).","['stage 3-4 chronic kidney disease (CKD', 'patients with chronic kidney disease', 'patients with hyperphosphatemia', 'Chinese patients with stage 3-4 chronic kidney disease', '97 patients with stage 3-4 CKD']","['coronary artery multidetector computed tomography (MDCT', 'oral activated charcoal (OAC', 'placebo', 'oral activated charcoal', 'calcium carbonate (CC) group and the lanthanum carbonate (LC) group', 'OAC']","['proportion of patients with hyperphosphatemia', 'hyperphosphatemia', 'coronary calcification score (CACS', 'hyperphosphatemia and vascular calcification']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemias'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C3179130', 'cui_str': 'Multislice Computed Tomography'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0001275', 'cui_str': 'medicinal charcoal'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemias'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0342649', 'cui_str': 'Vascular Calcinosis'}]",97.0,0.0162064,"In the first phase of the experiment, there was a statistically significant difference in the proportion of patients with hyperphosphatemia between the OAC and placebo groups (28.57% vs. 79.17%, X 2  = 24.958, P = 0.000).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Weifang Medical University, Weifang, People's Republic of China.""}, {'ForeName': 'Guiyun', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': ""Department of Nephrology, Chengxin Hospital of Yuncheng, Heze, 274700, Shandong, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Weifang Medical University, Weifang, People's Republic of China.""}, {'ForeName': 'Chenxiao', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': ""Weifang Medical University, Weifang, People's Republic of China.""}, {'ForeName': 'Zunsong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Nephrology, Qianfoshan Hospital, Shandong University, No. 16766 Jingshi Road, Jinan, 250014, Shandong, People's Republic of China. wzsong3@163.com.""}]",Journal of nephrology,['10.1007/s40620-018-00571-1']
71,30987814,Chlorhexidine for meatal cleaning in reducing catheter-associated urinary tract infections: a multicentre stepped-wedge randomised controlled trial.,"BACKGROUND


Evidence for the benefits of antiseptic meatal cleaning in reducing catheter-associated urinary tract infection (UTI) is inconclusive. We assessed the efficacy of 0·1% chlorhexidine solution compared with normal saline for meatal cleaning before urinary catheter insertion in reducing the incidence of catheter-associated asymptomatic bacteriuria and UTI.
METHODS


A cross-sectional, stepped-wedge, open-label, randomised controlled trial was undertaken in Australian hospitals. Eligible hospitals were Australian public and private hospitals, with an intensive care unit and more than 30 000 hospital admissions per year. Hospitals were randomly assigned to an intervention crossover date using a computer-generated randomisation system. Crossover dates occurred every 8 weeks; during the first 8 weeks of the study, no hospitals were exposed to the intervention (control phase), after which each hospital sequentially crossed over from the control to the intervention every 8 weeks. Patients requiring a urinary cathetwer were potentially eligible for inclusion in this hospital-wide study. Participants were excluded if they were younger than 2 years, had a medical reason preventing the use of the chlorhexidine, had the catheter inserted in theatre, did not have the catheter insertion date documented, required in-and-out or suprapubic catheterisation, had symptoms and signs suggestive of UTI at the time of catheter insertion, or were currently undergoing treatment for UTI. The intervention was the use of 0·1% chlorhexidine solution for meatal cleaning before urinary catheterisation with 0·9% normal saline used in the control phase. Masking of hospitals was not possible because it was not feasible to mask staff administering the intervention. The co-primary outcomes were the number of cases of catheter-associated asymptomatic bacteriuria and UTI per 100 catheter-days and were assessed within 7 days of catheter insertion in the intention-to-treat population. This trial is registered with Australian New Zealand Clinical Trials Registry, number ACTRN12617000373370.
FINDINGS


21 hospitals were assessed for eligibility between Jan 5, 2017, and May 1, 2017; of these, three were successfully enrolled and randomised to one of three intervention crossover dates. 1642 participants in these hospitals were included in the study between Aug 1, 2017, and March 12, 2018, 697 (42%) in the control phase and 945 (58%) in the intervention period. In the control period, 13 catheter-associated UTI and 29 catheter-associated asymptomatic bacteriuria events in 2889 catheter-days (0·45 catheter-associated UTI cases and 1·00 catheter-associated asymptomatic bacteriuria cases per 100 catheter-days) were recorded compared with four catheter-associated UTI and 16 catheter-associated asymptomatic bacteriuria events in 2338 catheter-days (0·17 catheter-associated UTI cases and 0·68 catheter-associated asymptomatic bacteriuria cases per 100 catheter-days) during the intervention period. The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080). There were no reported adverse events.
INTERPRETATION


The use of chlorhexidine solution for meatal cleaning before catheter insertion decreased the incidence of catheter-associated asymptomatic bacteriuria and UTI and has the potential to improve patient safety.
FUNDING


HCF Research Foundation.",2019,"The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080).","['Participants were excluded if they were younger than 2 years, had a medical reason preventing the use of the chlorhexidine, had the catheter inserted in theatre, did not have the catheter insertion date documented, required in-and-out or suprapubic catheterisation, had symptoms and signs suggestive of UTI at the time of catheter insertion, or were currently undergoing treatment for UTI', 'Australian hospitals', '1642 participants in these hospitals were included in the study between Aug 1, 2017, and March 12, 2018, 697 (42%) in the control phase and 945 (58%) in the intervention period', '21 hospitals were assessed for eligibility between Jan 5, 2017, and May 1, 2017; of these, three were successfully enrolled', 'Patients requiring a urinary cathetwer were potentially eligible for inclusion in this hospital-wide study', 'Eligible hospitals were Australian public and private hospitals, with an intensive care unit and more than 30\u2008000 hospital admissions per year']","['Chlorhexidine', 'normal saline', 'chlorhexidine solution', 'antiseptic meatal cleaning', 'chlorhexidine solution for meatal cleaning before urinary catheterisation with 0·9% normal saline']","['incidence of catheter-associated asymptomatic bacteriuria', 'adverse events', 'catheter-associated urinary tract infections', 'number of cases of catheter-associated asymptomatic bacteriuria and UTI per 100 catheter-days', 'incidence of catheter-associated UTI', 'asymptomatic bacteriuria events']","[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0439508', 'cui_str': 'per year'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0042019', 'cui_str': 'Urinary Catheterization'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",21.0,0.152964,"The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080).","[{'ForeName': 'Oyebola', 'Initials': 'O', 'LastName': 'Fasugba', 'Affiliation': ""Nursing Research Institute, Australian Catholic University & St Vincent's Health Australia, Sydney, NSW, Australia; Lifestyle Research Centre, Avondale College of Higher Education, Cooranbong, NSW, Australia.""}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Infectious Prevention and Healthcare Epidemiology Unit, Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gregory', 'Affiliation': 'Faculty of Arts, Nursing and Theology, Avondale College of Higher Education, Wahroonga, NSW, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Graves', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Koerner', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine Australian Catholic University, Watson, ACT, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Collignon', 'Affiliation': 'Australian Capital Territory Pathology, Canberra Hospital and Health Services, Yamba Drive, Garran, ACT, Australia; Medical School, Australian National University, Acton, ACT, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'School of Public Health and Social Work, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'Mitchell', 'Affiliation': 'Faculty of Arts, Nursing and Theology, Avondale College of Higher Education, Wahroonga, NSW, Australia; School of Nursing and Midwifery, University of Newcastle, Newcastle, NSW, Australia. Electronic address: brett.mitchell@avondale.edu.au.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30736-9']
72,29928755,Prophylactic abdominal drainage for pancreatic surgery.,"BACKGROUND


The use of surgical drains has been considered mandatory after pancreatic surgery. The role of prophylactic abdominal drainage to reduce postoperative complications after pancreatic surgery is controversial.
OBJECTIVES


To assess the benefits and harms of routine abdominal drainage after pancreatic surgery, compare the effects of different types of surgical drains, and evaluate the optimal time for drain removal.
SEARCH METHODS


For the last version of this review, we searched CENTRAL (2016, Issue 8), and MEDLINE, Embase, Science Citation Index Expanded, and Chinese Biomedical Literature Database (CBM) to 28 August 2016). For this updated review, we searched CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, and CBM from 2016 to 15 November 2017.
SELECTION CRITERIA


We included all randomized controlled trials that compared abdominal drainage versus no drainage in people undergoing pancreatic surgery. We also included randomized controlled studies that compared different types of drains and different schedules for drain removal in people undergoing pancreatic surgery.
DATA COLLECTION AND ANALYSIS


We identified six studies (1384 participants). Two review authors independently identified the studies for inclusion, collected the data, and assessed the risk of bias. We performed the meta-analyses using Review Manager 5. We calculated the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes with 95% confidence intervals (CI). For all analyses, we used the random-effects model.
MAIN RESULTS


Drain use versus no drain useWe included four studies with 1110 participants, who were randomized to the drainage group (N = 560) and the no drainage group (N = 550) after pancreatic surgery. There was little or no difference in mortality at 30 days between groups (1.5% with drains versus 2.3% with no drains; RR 0.78, 95% CI 0.31 to 1.99; four studies, 1055 participants; moderate-quality evidence). Drain use probably slightly reduced mortality at 90 days (0.8% versus 4.2%; RR 0.23, 95% CI 0.06 to 0.90; two studies, 478 participants; moderate-quality evidence). We were uncertain whether drain use reduced intra-abdominal infection (7.9% versus 8.2%; RR 0.97, 95% CI 0.52 to 1.80; four studies, 1055 participants; very low-quality evidence), or additional radiological interventions for postoperative complications (10.9% versus 12.1%; RR 0.87, 95% CI 0.79 to 2.23; three studies, 660 participants; very low-quality evidence). Drain use may lead to similar amount of wound infection (9.8% versus 9.9%; RR 0.98 , 95% CI 0.68 to 1.41; four studies, 1055 participants; low-quality evidence), and additional open procedures for postoperative complications (9.4% versus 7.1%; RR 1.33, 95% CI 0.79 to 2.23; four studies, 1055 participants; low-quality evidence) when compared with no drain use. There was little or no difference in morbidity (61.7% versus 59.7%; RR 1.03, 95% CI 0.94 to 1.13; four studies, 1055 participants; moderate-quality evidence), or length of hospital stay (MD -0.66 days, 95% CI -1.60 to 0.29; three studies, 711 participants; moderate-quality evidence) between groups. There was one drain-related complication in the drainage group (0.2%). Health-related quality of life was measured with the pancreas-specific quality-of-life questionnaire (FACT-PA; a scale of 0 to 144 with higher values indicating a better quality of life). Drain use may lead to similar quality of life scores, measured at 30 days after pancreatic surgery, when compared with no drain use (105 points versus 104 points; one study, 399 participants; low-quality evidence). Hospital costs and pain were not reported in any of the studies.Type of drainWe included one trial involving 160 participants, who were randomized to the active drain group (N = 82) and the passive drain group (N = 78) after pancreatic surgery. An active drain may lead to similar mortality at 30 days (1.2% with active drain versus 0% with passive drain; low-quality evidence), and morbidity (22.0% versus 32.1%; RR 0.68, 95% CI 0.41 to 1.15; low-quality evidence) when compared with a passive drain. We were uncertain whether an active drain decreased intra-abdominal infection (0% versus 2.6%; very low-quality evidence), wound infection (6.1% versus 9.0%; RR 0.68, 95% CI 0.23 to 2.05; very low-quality evidence), or the number of additional open procedures for postoperative complications (1.2% versus 7.7%; RR 0.16, 95% CI 0.02 to 1.29; very low-quality evidence). Active drain may reduce length of hospital stay slightly (MD -1.90 days, 95% CI -3.67 to -0.13; one study; low-quality evidence; 14.1% decrease of an 'average' length of hospital stay). Additional radiological interventions, pain, and quality of life were not reported in the study.Early versus late drain removalWe included one trial involving 114 participants with a low risk of postoperative pancreatic fistula, who were randomized to the early drain removal group (N = 57) and the late drain removal group (N = 57) after pancreatic surgery. There was no mortality in either group. Early drain removal may slightly reduce morbidity (38.6% with early drain removal versus 61.4% with late drain removal; RR 0.63, 95% CI 0.43 to 0.93; low-quality evidence), length of hospital stay (MD -2.10 days, 95% CI -4.17 to -0.03; low-quality evidence; 21.5% decrease of an 'average' length of hospital stay), and hospital costs (MD -EUR 2069.00, 95% CI -3872.26 to -265.74; low-quality evidence; 17.0% decrease of 'average' hospital costs). We were uncertain whether early drain removal reduced additional open procedures for postoperative complications (0% versus 1.8%; RR 0.33, 95% CI 0.01 to 8.01; one study; very low-quality evidence). Intra-abdominal infection, wound infection, additional radiological interventions, pain, and quality of life were not reported in the study.
AUTHORS' CONCLUSIONS


It was unclear whether routine abdominal drainage had any effect on the reduction of mortality at 30 days, or postoperative complications after pancreatic surgery. Moderate-quality evidence suggested that routine abdominal drainage probably slightly reduced mortality at 90 days. Low-quality evidence suggested that use of an active drain compared to the use of a passive drain may slightly reduce the length of hospital stay after pancreatic surgery, and early removal may be superior to late removal for people with low risk of postoperative pancreatic fistula.",2018,"There was little or no difference in morbidity (61.7% versus 59.7%; RR 1.03, 95% CI 0.94 to 1.13; four studies, 1055 participants; moderate-quality evidence), or length of hospital stay (MD -0.66 days, 95% CI -1.60 to 0.29; three studies, 711 participants; moderate-quality evidence) between groups.","['160 participants', '2016 to 15 November 2017', '114 participants with a low risk of postoperative pancreatic fistula, who were randomized to the early drain removal group (N = 57) and the late drain removal group (N = 57) after pancreatic surgery', 'pancreatic surgery', 'Drain use versus no drain useWe included four studies with 1110 participants', 'people undergoing pancreatic surgery']","['Prophylactic abdominal drainage', 'abdominal drainage versus no drainage', 'active drain', 'prophylactic abdominal drainage', 'passive drain group (N = 78) after pancreatic surgery']","['Intra-abdominal infection, wound infection, additional radiological interventions, pain, and quality of life', 'postoperative complications', 'pain, and quality of life', 'drain-related complication', 'length of hospital stay', 'intra-abdominal infection', ""average' length of hospital stay), and hospital costs"", 'moderate-quality evidence), or length of hospital stay', 'Health-related quality of life', 'quality of life', 'Hospital costs and pain', 'mortality', 'morbidity', 'wound infection', 'risk ratio (RR']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1112209', 'cui_str': 'Intra-Abdominal Infections'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",114.0,0.317971,"There was little or no difference in morbidity (61.7% versus 59.7%; RR 1.03, 95% CI 0.94 to 1.13; four studies, 1055 participants; moderate-quality evidence), or length of hospital stay (MD -0.66 days, 95% CI -1.60 to 0.29; three studies, 711 participants; moderate-quality evidence) between groups.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Hepatopancreatobiliary Surgery, The People's Hospital of Jianyang City, No. 180, Hospital Road, Jianyang, Sichuan, China, 641499.""}, {'ForeName': 'Sirong', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Lai', 'Affiliation': ''}, {'ForeName': 'Nansheng', 'Initials': 'N', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Zuojin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010583.pub4']
73,27885650,Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.,"BACKGROUND


Ustekinumab (CNTO 1275) and briakinumab (ABT-874) are monoclonal antibodies that target the standard p40 subunit of the cytokines interleukin-12 and interleukin-23 (IL-12/23p40), which are involved in the pathogenesis of Crohn's disease.
OBJECTIVES


The objectives of this review were to assess the efficacy and safety of anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.
SEARCH METHODS


We searched the following databases from inception to 12 September 2016: PubMed, MEDLINE, EMBASE, and the Cochrane Library (CENTRAL). References and conference abstracts were searched to identify additional studies.
SELECTION CRITERIA


Randomized controlled trials (RCTs) trials in which monoclonal antibodies against IL-12/23p40 were compared to placebo or another active comparator in patients with active Crohn's disease were included.  DATA COLLECTION AND ANALYSIS: Two authors independently screened  studies for inclusion and extracted data. Methodological quality was assessed using the Cochrane risk of bias tool. The primary outcome was failure to induce clinical remission, defined as a Crohn's disease activity index (CDAI) of < 150 points. Secondary outcomes included failure to induce clinical improvement, adverse events, serious adverse events, and withdrawals due to adverse events. Clinical improvement was defined as decreases of > 70 or > 100 points in the CDAI from baseline. We calculated the risk ratio (RR) and 95% confidence intervals (95% CI) for each outcome. Data were analyzed on an intention-to-treat basis. The overall quality of the evidence supporting the outcomes was evaluated using the GRADE criteria.
MAIN RESULTS


Six RCTs (n = 2324 patients) met the inclusion criteria. A low risk of bias was assigned to all studies. The two briakinumab trials were not pooled due to differences in doses and time points for analysis. In both studies there was no statistically significant difference in remission rates. One study (n = 79) compared doses of 1 mg/kg and 3 mg/kg to placebo. In the briakinumab group 70% (44/63) of patients failed to enter clinical remission at 6 or 9 weeks compared to 81% (13/16) of placebo patients (RR 0.86, 95% CI 0.65 to 1.14). Subgroup analysis revealed no significant differences by dose. The other briakinumab study (n = 230) compared intravenous doses of 200 mg, 400 mg and 700 mg with placebo. Eighty-four per cent (154/184) of briakinumab patients failed to enter clinical remission at six weeks compared to 91% (42/46) of placebo patients (RR 0.92, 95% CI 0.83 to 1.03). Subgroup analysis revealed no significant differences by dose. GRADE analyses of the briakinumab studies rated the overall quality of the evidence for the outcome clinical remission as low. Based on the results of these two studies the manufacturers of briakinumab stopped production of this medication. The ustekinumab studies were pooled despite differences in intravenous doses (i.e. 1mg/kg, 3 mg/kg, 4.5 mg/kg, and 6 mg/kg), however the subcutaneous dose group was not included in the analysis, as it was unclear if subcutaneous was equivalent to intravenous dosing. There was a statistically significant difference in remission rates. At week six, 84% (764/914) of ustekinumab patients failed to enter remission compared to 90% (367/406) of placebo patients (RR 0.92, 95% CI 0.88 to 0.96; 3 studies; high-quality evidence). Subgroup analysis showed a statistically significant difference for the 6.0 mg/kg dose group (moderate-quality evidence). There were statistically significant differences in clinical improvement between ustekinumab and placebo-treated patients. In the ustekinumab group, 55% (502/914) of patients failed to improve clinically (i.e. 70-point decline in CDAI score), compared to 71% (287/406) of placebo patients (RR 0.78, 95% CI 0.71 to 0.85; 3 studies). Subgroup analysis revealed significant differences compared to placebo for the 1 mg/kg, 4.5 mg/kg and 6 mg/kg dosage subgroups. Similarly for a 100-point decline in CDAI, 64% (588/914) of patients in the ustekinumab group failed to improve clinically compared to 78% (318/406) of placebo patients (RR 0.82, 95% CI 0.77 to 0.88; 3 studies; high-quality evidence). Subgroup analysis showed a significant difference compared to placebo for the 4.5 mg/kg and 6.0 mg/kg (high-quality evidence) dose groups. There were no statistically significant differences in the incidence of adverse events, serious adverse events or withdrawal due to adverse events. Sixty-two per cent (860/1386) of ustekinumab patients developed at least one adverse event compared to 64% (407/637) of placebo patients (RR 0.97, 95% CI 0.90 to 1.04; 4 studies; high-quality evidence). Five per cent (75/1386) of ustekinumab patients had a serious adverse event compared to 6% (41/637) of placebo patients (RR 0.83, 95% CI 0.58 to 1.20; 4 studies; moderate-quality evidence). The most common adverse events in briakinumab patients were injection site reactions and infections. Infections were the most common adverse event in ustekinumab patients. Worsening of Crohn's disease and serious infections were the most common serious adverse events.
AUTHORS' CONCLUSIONS


High quality evidence suggests that ustekinumab is effective for induction of clinical remission and clinical improvement in patients with moderate to severe Crohn's disease. Moderate to high quality evidence suggests that the optimal dosage of ustekinumab is 6 mg/kg. Briakinumab and ustekinumab appear to be safe. Moderate quality evidence suggests no increased risk of serious adverse events. Future studies are required to determine the long-term efficacy and safety of ustekinumab in patients with moderate to severe Crohn's disease.",2016,"There were no statistically significant differences in the incidence of adverse events, serious adverse events or withdrawal due to adverse events.","[""patients with active Crohn's disease were included"", ""Crohn's disease"", 'Six RCTs (n = 2324 patients) met the inclusion criteria', ""patients with moderate to severe Crohn's disease""]","['placebo', 'ustekinumab', 'Anti-IL-12/23p40 antibodies', 'anti-IL-12/23p40 antibodies', 'Briakinumab and ustekinumab']","[""Worsening of Crohn's disease and serious infections"", 'CDAI score', 'serious adverse event', 'clinical improvement', ""failure to induce clinical remission, defined as a Crohn's disease activity index (CDAI"", 'risk of serious adverse events', 'failure to induce clinical improvement, adverse events, serious adverse events, and withdrawals due to adverse events', 'clinical remission', 'Methodological quality', 'enter remission', 'efficacy and safety', 'adverse event', 'remission rates', 'incidence of adverse events, serious adverse events or withdrawal due to adverse events', 'risk ratio (RR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C2744325', 'cui_str': 'briakinumab'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index (assessment scale)""}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",2324.0,0.709342,"There were no statistically significant differences in the incidence of adverse events, serious adverse events or withdrawal due to adverse events.","[{'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': 'Cochrane IBD Group, Robarts Clinical Trials, 100 Dundas Street, Suite 200, London, ON, Canada, N6A 5B6.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': ''}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Timmer', 'Affiliation': ''}]",The Cochrane database of systematic reviews,[]
74,31668142,Inter and Intra Operator Reliability of Motor and Palpation Evaluation in Fascial Manipulation in individuals with coxarthrosis.,"OBJECTIVE


An inter and intra rater reliability (INTERR and INTRAR) study was designed.
METHODS


71 subjects, with primary hip coxarthrosis, were included and randomly divided in a study group (SG= 36) and a control group (CG= 35) to assess the efficacy of the Fascial Manipulation® (FM®) method. The primary objective was the assessment of INTERR and INTRAR about movement verification (MV) and palpation verification (PV) of FM® performed by two physiotherapists (PtA and PtB). The secondary objective was evaluate the efficacy of FM® through MV, PV and pain score. Pain was assessed using the Numeric Rating Scale (NRS). SG received three weekly sessions of FM® byPtA. PtB re-evaluated all the subjects at the end of the study.
RESULTS


Results of the INTERR analysis showed for SG: MV (ICC= 0.92, k= 72.7%); PV (ICC= 0.91, k= 75.7%). For CG : MV (ICC= 0.95, k= 84.2%); PV (ICC= 0.90, k= 75%). Results of the INTRAR analysis for SG reported: MV (ICC= 0.82, k= 74,8%); PV (ICC= 0.60, k= 46.8%); for CG: MV (ICC= 0.93, k= 78.7%); PV (ICC= 0.84, k= 53.3%). Statistical significance were reported in NRS (p = 0.001), MV (p = 0.0003) and PV (p < 0.0001) with better results for SG using ""Intention To Treat"" method.
DISCUSSION


This study demonstrates that FM® assessment procedures have a high reliability even if applied by practitioners with basic experience. Furthermore FM® treatment can improve pain and ROM in individuals with primary coxarthrosis.",2020,"Statistical significance were reported in NRS (p = 0.001), MV (p = 0.0003) and PV (p < 0.0001) with better results for SG using ""Intention To Treat"" method.","['Methods : 71 subjects, with primary hip coxarthrosis', 'individuals with coxarthrosis', 'Discussion ', 'individuals with primary coxarthrosis']","['Furthermore FM® treatment', 'Fascial Manipulation® (FM®) method']","['efficacy of FM® through MV, PV and pain score', 'pain and ROM', 'Numeric Rating Scale (NRS', 'Pain', 'INTERR and INTRAR about movement verification (MV) and palpation verification (PV) of FM® performed by two physiotherapists (PtA and PtB']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0029410', 'cui_str': 'Coxarthrosis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}]",71.0,0.0258008,"Statistical significance were reported in NRS (p = 0.001), MV (p = 0.0003) and PV (p < 0.0001) with better results for SG using ""Intention To Treat"" method.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cotti', 'Affiliation': 'Department of Rehabilitation, Rizzoli Orthopaedic Institute, Bologna, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Del Corso', 'Affiliation': 'Freelance, Bologna, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diana', 'Affiliation': 'Freelance, Bologna, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Cornale', 'Affiliation': 'Freelance, Bologna, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Sudanese', 'Affiliation': 'Orthopaedic-Trauma and Prosthetic Surgery, Hip Revisions, Knee Implants, Rizzoli Institute, Bologna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Stecco', 'Affiliation': 'School of Medicine, New York University, New York, NY, USA.'}, {'ForeName': 'Mirco', 'Initials': 'M', 'LastName': 'Branchini', 'Affiliation': 'Department of Hip and Knee Prosthesis Surgery Unit, Rizzoli Orthopaedic Institute, Bologna, Italy.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2019.1683675']
75,30243422,Re-engineering methadone-Cost-effectiveness analysis of a patient-centered approach to methadone treatment.,"Methadone maintenance treatment has proven effectiveness in the treatment of opioid use disorder, but significant barriers remain to treatment retention. In a randomized clinical trial, 300 newly-admitted methadone patients were randomly assigned to patient-centered methadone (PCM) v. treatment-as-usual (TAU). In PCM, participants were treated under revised program rules which permitted voluntary attendance at counseling and other changes focused on reducing involuntary discharge, and different staff roles which shifted disciplinary responsibility from the participant's counselor to the supervisor. The study found no significant differences in treatment retention, measures of opioid use, or other patient outcomes. This paper employs an activity-based costing approach to estimate the cost and cost-effectiveness of the two study conditions. We found that service use and costs were similar between PCM and TAU. Specifically, the average cost for PCM patients was $2396 compared to $2292 for standard methadone, while the average length of stay was 2 weeks longer for PCM patients. Incremental cost-effectiveness ratios (ICER) for self-reported heroin use, opioid positive urine screens, and meeting DSM-IV criteria for opioid dependence were mixed, with TAU achieving non-significantly better outcomes at lower treatment episode costs (i.e., economically dominating) for opioid positive urine screens. PCM patients reported slightly more days abstinent from heroin and fewer meet the opioid dependence criteria. While these differences are small and not statistically significant, we can still examine the cost-effectiveness implications. For days, abstinent from heroin, the ICER was $242 for one additional day of abstinence, however, there was notable uncertainty around this estimate. For opioid dependence criteria, the ICER was $1160 for a one-percentage point increase in the probability that a participant no longer met criteria for opioid dependence at follow-up. This economic study finds that patient choice concepts can be introduced into methadone treatment without significant impacts on costs or patient outcomes.",2018,This economic study finds that patient choice concepts can be introduced into methadone treatment without significant impacts on costs or patient outcomes.,['300 newly-admitted methadone patients'],"['Methadone maintenance', 'patient-centered methadone (PCM) v. treatment-as-usual (TAU', 'PCM']","['average length of stay', 'average cost', 'Incremental cost-effectiveness ratios (ICER']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",300.0,0.0240141,This economic study finds that patient choice concepts can be introduced into methadone treatment without significant impacts on costs or patient outcomes.,"[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Dunlap', 'Affiliation': 'RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27709, United States of America. Electronic address: ljd@rti.org.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27709, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Orme', 'Affiliation': 'RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27709, United States of America.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Meinhofer', 'Affiliation': 'RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27709, United States of America.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD 21201, United States of America.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'University of Maryland College Park, Department of Psychology, 4094 Campus Dr., College Park, MD 20742, United States of America.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD 21201, United States of America.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD 21201, United States of America.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD 21201, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.07.014']
76,31668888,"Panretinal Photocoagulation for Diabetic Retinopathy in the RIDE and RISE Trials: Not ""1 and Done"".","PURPOSE


To evaluate panretinal photocoagulation (PRP) treatment and re-treatment patterns in patients with diabetic retinopathy (DR) and diabetic macular edema (DME).
DESIGN


Post hoc analysis of the phase 3 RIDE (clinicaltrials.gov identifier, NCT00473382) and RISE (clinicaltrials.gov identifier, NCT00473330) clinical trials of ranibizumab for the treatment of DME.
PARTICIPANTS


Seven hundred fifty-nine patients were randomized for treatment.
METHODS


Panretinal photocoagulation treatment patterns and clinical experiences were assessed by baseline PRP treatment status.
MAIN OUTCOME MEASURES


Number and timing of on-study PRP treatment sessions undergone through month 24. Time to new proliferative event (composite end point) was also assessed.
RESULTS


At baseline, approximately 25% of patients in RIDE and RISE had undergone PRP treatment before enrollment (22.2%, 24.4%, and 25.4% of patients in the sham, ranibizumab 0.3 mg, and ranibizumab 0.5 mg arms, respectively). In patients without prior PRP at baseline (n = 577), 9.5% of sham-treated patients underwent 1 or more PRP treatments through month 24, compared with 1.1% and 1.6% of patients receiving ranibizumab 0.3 mg and ranibizumab 0.5 mg, respectively (P < 0.001 for both ranibizumab arms vs. sham). In patients with prior PRP at baseline (n = 182), 19.3% of sham-treated patients underwent 1 or more PRP treatments through month 24. No ranibizumab-treated patients with prior PRP at baseline required additional on-study PRP through month 24 (P < 0.001 for both ranibizumab arms vs. sham). Ranibizumab treatment also significantly reduced clinical DR progression among patients who underwent prior PRP. By month 24 in patients with prior PRP at baseline, the probability of experiencing a new proliferative event was 10.3% and 9.9% in patients receiving ranibizumab 0.3 mg and ranibizumab 0.5 mg treatment, respectively, compared with 39.4% in sham-treated patients (P < 0.0001). Overall, sham-treated patients, including those patients who were PRP naïve at baseline who went on to require PRP, experienced more clinical events than ranibizumab-treated patients.
CONCLUSIONS


In RIDE and RISE, PRP treatment was not a ""1 and done"" procedure, with on-study PRP re-treatment occurring in patients both with and without prior PRP treatment at baseline. Ranibizumab treatment reduced on-study PRP treatment and DR progression regardless of prior PRP treatment status at baseline.",2021,Ranibizumab treatment reduced on-study PRP treatment and DR progression regardless of prior PRP treatment status at baseline.,"['Diabetic Retinopathy in the RIDE and RISE Trials', 'patients who underwent prior PRP', 'patients with diabetic retinopathy (DR) and diabetic macular edema (DME', 'Seven hundred fifty-nine patients']","['ranibizumab', 'Panretinal Photocoagulation', 'Ranibizumab', 'ranibizumab 0.3 mg and ranibizumab', 'panretinal photocoagulation (PRP']","['clinical events', 'clinical DR progression', 'probability of experiencing a new proliferative event']","[{'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]",759.0,0.14355,Ranibizumab treatment reduced on-study PRP treatment and DR progression regardless of prior PRP treatment status at baseline.,"[{'ForeName': 'Victor H', 'Initials': 'VH', 'LastName': 'Gonzalez', 'Affiliation': 'Valley Retina Institute, McAllen, Texas. Electronic address: maculadoc@aol.com.'}, {'ForeName': 'Pin-Wen', 'Initials': 'PW', 'LastName': 'Wang', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Carlos Quezada', 'Initials': 'CQ', 'LastName': 'Ruiz', 'Affiliation': 'Genentech, Inc., South San Francisco, California; Clinica de Ojos Garza Viejo, San Pedro Garza Garcia, NL, Mexico.'}]",Ophthalmology,['10.1016/j.ophtha.2019.08.010']
77,32409241,[Impact of antiplatelet and anticoagulant treatments on bleeding complications in patients treated with HoLEP].,"INTRODUCTION


We aimed to assess the impact of antiplatelet and anticoagulation therapy for patients undergoing HoLEP.
METHODS


We performed a study during the learning curve on a consecutive series of patients who underwent HoLEP surgery from 2015 to 2018. The patients were divided into 3 groups: a control group, patients with antiplatelet therapy and patients with anticoagulation therapy.
RESULTS


A total of 223 patients underwent HoLEP surgery during this period: 124 in the control group, 63 in the antiplatelet group and 36 in the anticoagulant group. In the anticoagulant group, we observe significant differences with the control group for the catheterization time (2.05 days vs 5.17 days; P<0.001), the hospital length of stay (1.5 nights vs 4.49 nights; P<0.001) and complications (8.9% vs 58%; P<0.001). No difference between the control and antiplatelet groups in terms of catheterization time, hospital length of stay and complications (2.05 days vs 2.68 days; 1.5 nights vs 1.6 nights) but variation in terms of complications and bleeding complications (8.9% vs 21%; P<0,001; 8.1% vs 19%; P<0,001) CONCLUSION: Our study shows that HoLEP is therefore associated with a higher risk of bleeding for patients treated with anticoagulation therapy. Complications increase morbidity with longer catheterization time, hospitalization times and higher transfusion's rates, revision surgery and readmission.
LEVEL OF EVIDENCE


3.",2020,"No difference between the control and antiplatelet groups in terms of catheterization time, hospital length of stay and complications (2.05 days vs 2.68 days; 1.5 nights vs 1.6 nights) but variation in terms of complications and bleeding complications (8.9% vs 21%; P<0,001; 8.1% vs 19%; P<0,001) CONCLUSION:","['patients who underwent HoLEP surgery from 2015 to 2018', 'patients treated with HoLEP', '223 patients underwent HoLEP surgery during this period: 124 in the control group, 63 in the antiplatelet group and 36 in the anticoagulant group', 'patients undergoing HoLEP']","['antiplatelet and anticoagulation therapy', 'HoLEP', 'antiplatelet and anticoagulant treatments', 'anticoagulation therapy', 'antiplatelet therapy']","['hospital length of stay', 'catheterization time', 'complications and bleeding complications', 'bleeding complications', 'catheterization time, hospital length of stay and complications', ""Complications increase morbidity with longer catheterization time, hospitalization times and higher transfusion's rates, revision surgery and readmission"", 'risk of bleeding', 'complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",223.0,0.0434497,"No difference between the control and antiplatelet groups in terms of catheterization time, hospital length of stay and complications (2.05 days vs 2.68 days; 1.5 nights vs 1.6 nights) but variation in terms of complications and bleeding complications (8.9% vs 21%; P<0,001; 8.1% vs 19%; P<0,001) CONCLUSION:","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Branchu', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France. Electronic address: bbranchu@chu-reims.fr.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Léon', 'Affiliation': ""Service d'urologie, clinique Pasteur, 17200 Royan, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fournier', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lasserre', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tambwe', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hoquetis', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Joncour', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Larré', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}]",Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie,['10.1016/j.purol.2020.04.018']
78,27706121,Reaction to the sensory integration therapy in children with postural stability deficits.,"BACKGROUND


The goal was to examine the influence of sensory integration therapy (SIT) on one leg standing in children with deficits of the postural stability.
METHODS


28 children 4-6 year old that could not stand on one leg for more than 20 seconds were randomly divided into control ""C"" and experimental ""E"" groups. Group ""C"" participated in standard classes in the kindergarten. Group ""E"" participated in sensory integration therapy (SIT) for 2 weeks, 5 times a week (additionally to the standard classes).
RESULTS


Results of the experiment show that the skill of standing on one leg has significantly improved (P<0.01) in the group that underwent additional therapy. The change in time of standing on the right leg with eyes open in the E group was statistically and significantly higher than the changes observed in the same time in group C (F=22.5, P=0.001' η 2 =0.44). Similarly, significant changes in time of standing on the right leg with eyes closed were observed in group E. The foregoing changes were bigger in group E than in group C (F=16. 1, P=0.004, η 2 =0.36). The analysis post hoc revealed that while there were no significant differences between the two groups on the pretest (P>0.05), there were significant differences between groups in right leg standing test with eyes open or closed on posttest. (P<0.05). Similar results were observed during on the one, left leg standing. The time of one leg standing with both eyes open and closed improved more significantly in group E than in group C (F=20.4, P=0.001, η 2 =0.42 respectively for the test with eyes open and F=7.4, P=0.010, η 2 =0.21 for the test with eyes closed). The analysis post hoc revealed that while there were no significant differences between the two groups on the pretest (P>0.05), there were significant differences between groups in left leg standing test with eyes open or closed on posttest (P<0.05).
CONCLUSIONS


Research conducted show that there is a positive influence of SIT on children with low level of postural stability. Its significant improvement in children with low levels of postural stability is important not only for the current functioning of those children but for their future - by protecting them from falling down and from injuries.",2021,"RESULTS


Results of the experiment show that the skill of standing on one leg has significantly improved (p<0.01) in the group that underwent additional therapy.","['children with postural stability deficits', 'children with deficits of the postural stability', '28 children 4 - 6 year old that could not stand on one leg for more than 20 seconds']","['sensory integration therapy', 'sensory integration therapy (SIT', 'control ""C"" and experimental ""E"" groups']","['right leg standing test', 'change in time of standing on the right leg', 'time of one leg standing', 'postural stability', 'time of standing on the right leg', 'left leg standing test', 'skill of standing on one leg']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0560210', 'cui_str': 'Does stand on one leg (finding)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C4087168', 'cui_str': 'Sensory integration therapy'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0230442', 'cui_str': 'Structure of right lower leg'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0560210', 'cui_str': 'Does stand on one leg (finding)'}]",28.0,0.0172096,"RESULTS


Results of the experiment show that the skill of standing on one leg has significantly improved (p<0.01) in the group that underwent additional therapy.","[{'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Maciaszek', 'Affiliation': 'Eugeniusz Piasecki University School of Physical Education, Poznań, Poland - jmaciaszek@awf.poznan.pl.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Kilan', 'Affiliation': 'Harmony Child Development Center, Skórzewo, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Bronikowski', 'Affiliation': 'Eugeniusz Piasecki University School of Physical Education, Poznań, Poland.'}]",Minerva pediatrics,['10.23736/S2724-5276.16.04607-7']
79,29501740,"Workplace health and safety intervention for child care staff: Rationale, design, and baseline results from the CARE cluster randomized control trial.","BACKGROUND


Low-wage workers suffer disproportionately high rates of chronic disease and are important targets for workplace health and safety interventions. Child care centers offer an ideal opportunity to reach some of the lowest paid workers, but these settings have been ignored in workplace intervention studies.
METHODS


Caring and Reaching for Health (CARE) is a cluster-randomized controlled trial evaluating efficacy of a multi-level, workplace-based intervention set in child care centers that promotes physical activity and other health behaviors among staff. Centers are randomized (1:1) into the Healthy Lifestyles (intervention) or the Healthy Finances (attention control) program. Healthy Lifestyles is delivered over six months including a kick-off event and three 8-week health campaigns (magazines, goal setting, behavior monitoring, tailored feedback, prompts, center displays, director coaching). The primary outcome is minutes of moderate and vigorous physical activity (MVPA); secondary outcomes are health behaviors (diet, smoking, sleep, stress), physical assessments (body mass index (BMI), waist circumference, blood pressure, fitness), and workplace supports for health and safety.
RESULTS


In total, 56 centers and 553 participants have been recruited and randomized. Participants are predominately female (96.7%) and either Non-Hispanic African American (51.6%) or Non-Hispanic White (36.7%). Most participants (63.4%) are obese. They accumulate 17.4 (±14.2) minutes/day of MVPA and consume 1.3 (±1.4) and 1.3 (±0.8) servings/day of fruits and vegetables, respectively. Also, 14.2% are smokers; they report 6.4 (±1.4) hours/night of sleep; and 34.9% are high risk for depression.
CONCLUSIONS


Baseline data demonstrate several serious health risks, confirming the importance of workplace interventions in child care.",2018,"METHODS


Caring and Reaching for Health (CARE) is a cluster-randomized controlled trial evaluating efficacy of a multi-level, workplace-based intervention set in child care centers that promotes physical activity and other health behaviors among staff.","['Caring and Reaching for Health (CARE', 'child care centers', 'child care staff', 'In total, 56 centers and 553 participants have been recruited and randomized', 'Participants are predominately female (96.7%) and either Non-Hispanic African American (51.6%) or Non-Hispanic White (36.7']","['multi-level, workplace-based intervention set', 'Healthy Lifestyles (intervention) or the Healthy Finances (attention control) program']","['minutes of moderate and vigorous physical activity (MVPA); secondary outcomes are health behaviors (diet, smoking, sleep, stress), physical assessments (body mass index (BMI), waist circumference, blood pressure, fitness), and workplace supports for health and safety']","[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018687'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.078907,"METHODS


Caring and Reaching for Health (CARE) is a cluster-randomized controlled trial evaluating efficacy of a multi-level, workplace-based intervention set in child care centers that promotes physical activity and other health behaviors among staff.","[{'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 245 Rosenau Hall, CB 7461, Chapel Hill, NC 27599-7461, USA; Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., Chapel Hill, NC 27599-7426, USA. Electronic address: dsward@email.unc.edu.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., Chapel Hill, NC 27599-7426, USA. Electronic address: avaughn@email.unc.edu.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Hales', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 245 Rosenau Hall, CB 7461, Chapel Hill, NC 27599-7461, USA; Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., Chapel Hill, NC 27599-7426, USA. Electronic address: derekh@email.unc.edu.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Viera', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of North Carolina at Chapel Hill, 590 Manning Drive, Chapel Hill, NC 27599, USA. Electronic address: anthony.viera@duke.edu.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Gizlice', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., Chapel Hill, NC 27599-7426, USA. Electronic address: ziya_gizlice@unc.edu.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Bateman', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., Chapel Hill, NC 27599-7426, USA. Electronic address: lbateman@email.unc.edu.'}, {'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 302 Rosenau Hall, CB 7440, Chapel Hill, NC 27599-7440, USA. Electronic address: agrummon@live.unc.edu.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Arandia', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 302 Rosenau Hall, CB 7440, Chapel Hill, NC 27599-7440, USA. Electronic address: arandia@live.unc.edu.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Linnan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 302 Rosenau Hall, CB 7440, Chapel Hill, NC 27599-7440, USA. Electronic address: linnan@email.unc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.02.018']
80,28840194,Rectus Muscle Reapproximation at Cesarean Delivery and Postoperative Pain: A Randomized Controlled Trial.,"Objective   Rectus muscle reapproximation at cesarean delivery (CD) is performed frequently by some obstetricians; however, the effect on postoperative pain is unclear. To this end, we investigated whether rectus muscle reapproximation increases postoperative pain.  Materials and Methods   This is a prospective, double-blind, randomized controlled trial of women undergoing primary CD with singleton or twin pregnancy at >35 weeks' gestation. Women were randomized to rectus muscle reapproximation with three interrupted sutures or no reapproximation. Exclusion criteria were prior cesarean, prior laparotomy, vertical skin incision, active labor, chronic analgesia use, allergy to opioid or nonsteroidal anti-inflammatory drugs, and body mass index ≥ 40. Intra- and postoperative pain management was standardized within the study protocol. The primary outcome was a combined movement pain and opioid use score averaged over the 72-hour study period, called the Silverman integrated assessment. Movement pain scores were assessed at 24, 48, and 72 postoperative hours.  Results   In total, 63 women were randomized, of whom 35 underwent rectus muscle reapproximation and 28 did not. Demographic and obstetric variables were similar between groups. Silverman integrated assessment scores during the 72-hour postoperative period were higher in the rectus muscle reapproximation group (15 ± 100% vs. -31 ± 78% difference from the mean;  p   = 0.04). Operative times were similar between groups (63 ± 15 vs. 65 ± 15 minutes;  p   = 0.61), and there were no surgical complications in either group. Maternal satisfaction with analgesia at 72 hours was high in both groups (85% [73-90] rectus muscle reapproximation vs. 90% [75-100];  p   = 0.16).  Conclusion   Rectus muscle reapproximation increased immediate postoperative pain without differences in operative time, surgical complications, or maternal satisfaction. Benefits of rectus muscle reapproximation should be weighed against increased postoperative pain, and analgesia should be planned accordingly.",2017,"Operative times were similar between groups (63 ± 15 vs. 65 ± 15 minutes;  p   = 0.61), and there were no surgical complications in either group.","[""women undergoing primary CD with singleton or twin pregnancy at >35 weeks' gestation"", 'Exclusion criteria were prior cesarean, prior laparotomy, vertical skin incision, active labor, chronic analgesia use, allergy to opioid or nonsteroidal anti-inflammatory drugs, and body mass index\u2009≥', '63 women were randomized, of whom 35 underwent rectus muscle reapproximation and 28 did not']","['Objective  \u2003Rectus muscle reapproximation at cesarean delivery (CD', 'rectus muscle reapproximation with three interrupted sutures or no reapproximation', 'rectus muscle reapproximation']","['Movement pain scores', 'operative time, surgical complications, or maternal satisfaction', 'Demographic and obstetric variables', 'Maternal satisfaction with analgesia', 'combined movement pain and opioid use score averaged over the 72-hour study period, called the Silverman integrated assessment', 'Intra- and postoperative pain management', 'surgical complications', 'Operative times', 'Rectus Muscle Reapproximation at Cesarean Delivery and Postoperative Pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0152150', 'cui_str': 'Pregnancy, Twin'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0233081', 'cui_str': 'Normal labor (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0448311', 'cui_str': 'Rectus eye muscle structure (body structure)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0448311', 'cui_str': 'Rectus eye muscle structure (body structure)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0448311', 'cui_str': 'Rectus eye muscle structure (body structure)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}]",63.0,0.363564,"Operative times were similar between groups (63 ± 15 vs. 65 ± 15 minutes;  p   = 0.61), and there were no surgical complications in either group.","[{'ForeName': 'Deirdre J', 'Initials': 'DJ', 'LastName': 'Lyell', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Naqvi', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Urban', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Carvalho', 'Affiliation': 'Department of Anesthesia, Stanford University School of Medicine, Stanford, California.'}]","Surgery journal (New York, N.Y.)",['10.1055/s-0037-1604074']
81,31729280,"An Experimental Investigation of Victim Blaming in Sexual Assault: The Roles of Victim Sexual Orientation, Coercion Type, and Stereotypes About Bisexual Women.","Bisexual women are more likely to be sexually assaulted and to receive negative reactions to disclosures of sexual assault than heterosexual and lesbian women. However, few studies have examined the extent to which victim sexual orientation and related factors influence perceptions of sexual assault victims and perpetrators. To fill this gap, the current study used an experimental manipulation to examine the influence of victim sexual orientation and coercion type on perceptions of sexual assault victims and perpetrators. Participants ( N  = 826) were randomly assigned to read one of nine vignettes in which the sexual orientation of the female victim (bisexual, lesbian, heterosexual) and the type of coercion (verbal, physical, alcohol incapacitation) were varied. Then, participants were asked a series of questions about the victim and the perpetrator. Results indicated that bisexual and heterosexual female victims were both perceived as having wanted to have sex with the perpetrator more and as having ""led the perpetrator on"" more than lesbian victims. In contrast, victim sexual orientation was not associated with explicit ratings of victim or perpetrator responsibility or victim suffering. Bisexual female victims were also perceived as more promiscuous than both lesbian and heterosexual female victims. In turn, perceiving the victim as more promiscuous was associated with perceiving the victim as more responsible, having wanted to have sex with the perpetrator more, having ""led the perpetrator on"" more, and suffering less, and with perceiving the perpetrator as less responsible. In sum, our findings suggest that efforts to reduce sexual violence toward bisexual women should attend to negative attitudes toward bisexual women, especially the perception of bisexual women as promiscuous.",2021,Bisexual women are more likely to be sexually assaulted and to receive negative reactions to disclosures of sexual assault than heterosexual and lesbian women.,"['bisexual and heterosexual female victims', 'Sexual Assault', 'Bisexual women', 'Bisexual female victims', 'Participants ( N  = 826']","['nine vignettes in which the sexual orientation of the female victim (bisexual, lesbian, heterosexual) and the type of coercion (verbal, physical, alcohol incapacitation']",['sexual violence'],"[{'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault (event)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0205949', 'cui_str': 'Sexual Orientation'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C1533642', 'cui_str': 'Women Who Have Sex With Women'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0009236', 'cui_str': 'Coercion'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C3489576', 'cui_str': 'Sexual Violence'}]",826.0,0.0157665,Bisexual women are more likely to be sexually assaulted and to receive negative reactions to disclosures of sexual assault than heterosexual and lesbian women.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dyar', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Feinstein', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'RaeAnn E', 'Initials': 'RE', 'LastName': 'Anderson', 'Affiliation': 'University of North Dakota, Grand Forks, USA.'}]",Journal of interpersonal violence,['10.1177/0886260519888209']
82,31615775,"Effects of moderately increased testosterone concentration on physical performance in young women: a double blind, randomised, placebo controlled study.","OBJECTIVE


To investigate the effects of a moderate increase in serum testosterone on physical performance in young, physically active, healthy women.
METHODS


A double blind, randomised, placebo controlled trial was conducted between May 2017 and June 2018 (ClinicalTrials.gov ID: NCT03210558). 48 healthy, physically active women aged 18-35 years were randomised to 10 weeks of treatment with 10 mg of testosterone cream daily or placebo (1:1). All participants completed the study. The primary outcome measure was aerobic performance measured by running time to exhaustion (TTE). Secondary outcomes were anaerobic performance (Wingate test) and muscle strength (squat jump (SJ), counter movement jump (CMJ) and knee extension peak torque). Hormone levels were analysed and body composition assessed by dual energy X-ray absorptiometry.
RESULTS


Serum levels of testosterone increased from 0.9 (0.4) nmol/L to 4.3 (2.8) nmol/L in the testosterone supplemented group. TTE increased significantly by 21.17 s (8.5%) in the testosterone group compared with the placebo group (mean difference 15.5 s; P=0.045). Wingate average power, which increased by 15.2 W in the testosterone group compared with 3.2 W in the placebo group, was not significantly different between the groups (P=0.084). There were no significant changes in CMJ, SJ and knee extension. Mean change from baseline in total lean mass was 923 g for the testosterone group and 135 g for the placebo group (P=0.040). Mean change in lean mass in the lower limbs was 398 g and 91 g, respectively (P=0.041).
CONCLUSION


The study supports a causal effect of testosterone in the increase in aerobic running time as well as lean mass in young, physically active women.",2020,TTE increased significantly by 21.17 s (8.5%) in the testosterone group compared with the placebo group (mean difference 15.5 s; P=0.045).,"['48 healthy, physically active women aged 18-35 years', 'young, physically active, healthy women', 'young women', 'young, physically active women']","['placebo', 'testosterone concentration', 'testosterone cream daily or placebo', 'testosterone']","['anaerobic performance (Wingate test) and muscle strength (squat jump (SJ), counter movement jump (CMJ) and knee extension peak torque', 'aerobic performance measured by running time to exhaustion (TTE', 'total lean mass', 'aerobic running time', 'Hormone levels', 'physical performance', 'Serum levels of testosterone', 'TTE', 'CMJ, SJ and knee extension', 'Mean change in lean mass']","[{'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C2607857'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",48.0,0.787542,TTE increased significantly by 21.17 s (8.5%) in the testosterone group compared with the placebo group (mean difference 15.5 s; P=0.045).,"[{'ForeName': 'Angelica Lindén', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden angelica.linden-hirschberg@sll.se.""}, {'ForeName': 'Jona', 'Initials': 'J', 'LastName': 'Elings Knutsson', 'Affiliation': ""Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Helge', 'Affiliation': 'Swedish School of Sports and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Manne', 'Initials': 'M', 'LastName': 'Godhe', 'Affiliation': 'Swedish School of Sports and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ekblom', 'Affiliation': 'Swedish School of Sports and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Bermon', 'Affiliation': 'Monaco Institute of Sports Medicine, Monaco.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Ekblom', 'Affiliation': 'Astrand Laboratory of Work Physiology, The Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}]",British journal of sports medicine,['10.1136/bjsports-2018-100525']
83,31585944,"Penicillin V four times daily for five days versus three times daily for 10 days in patients with pharyngotonsillitis caused by group A streptococci: randomised controlled, open label, non-inferiority study.","OBJECTIVE


To determine whether total exposure to penicillin V can be reduced while maintaining adequate clinical efficacy when treating pharyngotonsillitis caused by group A streptococci.
DESIGN


Open label, randomised controlled non-inferiority study.
SETTING


17 primary healthcare centres in Sweden between September 2015 and February 2018.
PARTICIPANTS


Patients aged 6 years and over with pharyngotonsillitis caused by group A streptococci and three or four Centor criteria (fever ≥38.5°C, tender lymph nodes, coatings of the tonsils, and absence of cough).
INTERVENTIONS


Penicillin V 800 mg four times daily for five days (total 16 g) compared with the current recommended dose of 1000 mg three times daily for 10 days (total 30 g).
MAIN OUTCOME MEASURES


Primary outcome was clinical cure five to seven days after the end of antibiotic treatment. The non-inferiority margin was prespecified to 10 percentage points. Secondary outcomes were bacteriological eradication, time to relief of symptoms, frequency of relapses, complications and new tonsillitis, and patterns of adverse events.
RESULTS


Patients (n=433) were randomly allocated to the five day (n=215) or 10 day (n=218) regimen. Clinical cure in the per protocol population was 89.6% (n=181/202) in the five day group and 93.3% (n=182/195) in the 10 day group (95% confidence interval -9.7 to 2.2). Bacteriological eradication was 80.4% (n=156/194) in the five day group and 90.7% (n=165/182) in the 10 day group. Eight and seven patients had relapses, no patients and four patients had complications, and six and 13 patients had new tonsillitis in the five day and 10 day groups, respectively. Time to relief of symptoms was shorter in the five day group. Adverse events were mainly diarrhoea, nausea, and vulvovaginal disorders; the 10 day group had higher incidence and longer duration of adverse events.
CONCLUSIONS


Penicillin V four times daily for five days was non-inferior in clinical outcome to penicillin V three times daily for 10 days in patients with pharyngotonsillitis caused by group A streptococci. The number of relapses and complications did not differ between the two intervention groups. Five day treatment with penicillin V four times daily might be an alternative to the currently recommended 10 day regimen.
TRIAL REGISTRATION


EudraCT 2015-001752-30; ClinicalTrials.gov NCT02712307.",2019,"Adverse events were mainly diarrhoea, nausea, and vulvovaginal disorders; the 10 day group had higher incidence and longer duration of adverse events.
","['17 primary healthcare centres in Sweden between September 2015 and February 2018', 'Patients aged 6 years and over with pharyngotonsillitis caused by group A streptococci and three or four Centor criteria (fever ≥38.5°C, tender lymph nodes, coatings of the tonsils, and absence of cough', 'Patients (n=433']","['Penicillin V', 'penicillin V']","['Clinical cure', 'Time to relief of symptoms', 'new tonsillitis', 'Bacteriological eradication', 'duration of adverse events', 'bacteriological eradication, time to relief of symptoms, frequency of relapses, complications and new tonsillitis, and patterns of adverse events', 'clinical cure five to seven days', 'diarrhoea, nausea, and vulvovaginal disorders', 'number of relapses and complications']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0877148', 'cui_str': 'Pharyngotonsillitis'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4273906', 'cui_str': 'Centor criteria (assessment scale)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0240273', 'cui_str': 'Tender lymph node (finding)'}, {'cui': 'C0040421', 'cui_str': 'Tonsil'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}]","[{'cui': 'C0030840', 'cui_str': 'phenoxymethylpenicillin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0040425', 'cui_str': 'Tonsillitis'}, {'cui': 'C0205465', 'cui_str': 'Bacteriologic (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0152008', 'cui_str': 'Vulvovaginal disease (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",17.0,0.108415,"Adverse events were mainly diarrhoea, nausea, and vulvovaginal disorders; the 10 day group had higher incidence and longer duration of adverse events.
","[{'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Skoog Ståhlgren', 'Affiliation': 'Unit for Antibiotics and Infection Control, The Public Health Agency of Sweden, SE 171 82 Solna, Sweden gunilla.skoog.stahlgren@fohm.se.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Tyrstrup', 'Affiliation': 'Lundbergsgatan Primary Health Care Centre, Malmö, Sweden.'}, {'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Edlund', 'Affiliation': 'Unit for Antibiotics and Infection Control, The Public Health Agency of Sweden, SE 171 82 Solna, Sweden.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Giske', 'Affiliation': 'Division of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sigvard', 'Initials': 'S', 'LastName': 'Mölstad', 'Affiliation': 'Department of Clinical Sciences in Malmö, Family Medicine, Lund University, Malmö, Sweden.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Norman', 'Affiliation': 'Salem Primary Health Care Centre, Rönninge, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Rystedt', 'Affiliation': 'Närhälsan Södra Ryd Primary Health Care Center, Skövde, Sweden.'}, {'ForeName': 'Pär-Daniel', 'Initials': 'PD', 'LastName': 'Sundvall', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, Institute of Medicine, Sahlgrenska Academy at the University of Gothenburg, Göteborg, Sweden.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Hedin', 'Affiliation': 'Department of Clinical Sciences in Malmö, Family Medicine, Lund University, Malmö, Sweden.'}]",BMJ (Clinical research ed.),['10.1136/bmj.l5337']
84,28675814,"Gender, violence and resilience among Ugandan adolescents.","Resilience, commonly understood as the ability to maintain adaptive functioning in the face of adversity, has emerged as a salient entry point in the field of positive youth development. This study makes a unique contribution by exploring dimensions of resilience among adolescents in Uganda, examining associations between violence from different perpetrators and resilience, and testing whether sex moderates these relationships. Analyses are based on data from 3706 primary school students. Exploratory factor analysis (EFA) identified five factors underlying the construct of resilience: Emotional Support; Family Connectedness; School Connectedness; Social Assets; and Psychological Assets. We used regression analysis to investigate associations between these dependent variables, background characteristics, and experiences of violence (including exposure to intimate partner violence against female caregivers). Results reflect a complex relationship between violence and resilience, with patterns varying by perpetrator (e.g., teacher, peers, caregivers) and some evidence that the sex of the student moderates these dynamics. Overall, there is a consistently negative relationship between all violence measures and Psychological Assets. In addition, teacher violence is associated with lower resilience across factors and both caregiver violence and exposure to IPV are consistently associated with decreased Family Connectedness. These findings suggest that adolescents experiencing (and exposed to) violence from adults may be particularly vulnerable to internalizing and/or externalizing behaviors and withdrawal from the family. Findings point to preventing violence from teachers complemented with enhancing family relationships as promising avenues for resilience-strengthening interventions, and also emphasize the need to consider gendered strategies to ensure girls and boys benefit equally.",2017,Exploratory factor analysis (EFA) identified five factors underlying the construct of resilience: Emotional Support; Family Connectedness; School Connectedness; Social Assets; and Psychological Assets.,"['Ugandan adolescents', '3706 primary school students']",[],[],"[{'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]",[],[],3706.0,0.0245503,Exploratory factor analysis (EFA) identified five factors underlying the construct of resilience: Emotional Support; Family Connectedness; School Connectedness; Social Assets; and Psychological Assets.,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Namy', 'Affiliation': 'Raising Voices, Uganda. Electronic address: sophie@raisingvoices.org.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Carlson', 'Affiliation': 'University of Alabama, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Norcini Pala', 'Affiliation': 'Columbia University, USA.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Faris', 'Affiliation': 'Raising Voices, Uganda.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Knight', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Devries', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Naker', 'Affiliation': 'Raising Voices, Uganda.'}]",Child abuse & neglect,['10.1016/j.chiabu.2017.06.015']
85,28091362,Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults.,"BACKGROUND


Peanut allergy is common, life-threatening, and without therapeutic options. We evaluated peanut epicutaneous immunotherapy (EPIT) by using Viaskin Peanut for peanut allergy treatment.
OBJECTIVE


We sought to evaluate the clinical, safety, and immunologic effects of EPIT for the treatment of peanut allergy.
METHODS


In this multicenter, double-blind, randomized, placebo-controlled study, 74 participants with peanut allergy (ages 4-25 years) were treated with placebo (n = 25), Viaskin Peanut 100 μg (VP100; n = 24) or Viaskin Peanut 250 μg (VP250; n = 25; DBV Technologies, Montrouge, France). The primary outcome was treatment success after 52 weeks, which was defined as passing a 5044-mg protein oral food challenge or achieving a 10-fold or greater increase in successfully consumed dose from baseline to week 52. Adverse reactions and mechanistic changes were assessed.
RESULTS


At week 52, treatment success was achieved in 3 (12%) placebo-treated participants, 11 (46%) VP100 participants, and 12 (48%) VP250 participants (P = .005 and P = .003, respectively, compared with placebo; VP100 vs VP250, P = .48). Median change in successfully consumed doses were 0, 43, and 130 mg of protein in the placebo, VP100, and VP250 groups, respectively (placebo vs VP100, P = .014; placebo vs VP250, P = .003). Treatment success was higher among younger children (P = .03; age, 4-11 vs >11 years). Overall, 14.4% of placebo doses and 79.8% of VP100 and VP250 doses resulted in reactions, predominantly local patch-site and mild reactions (P = .003). Increases in peanut-specific IgG 4  levels and IgG 4 /IgE ratios were observed in peanut EPIT-treated participants, along with trends toward reduced basophil activation and peanut-specific T H 2 cytokines.
CONCLUSIONS


Peanut EPIT administration was safe and associated with a modest treatment response after 52 weeks, with the highest responses among younger children. This, when coupled with a high adherence and retention rate and significant changes in immune pathways, supports further investigation of this novel therapy.",2017,"Treatment success was higher among younger children (P = .03; age, 4-11 vs ","['peanut allergy in children and young adults', '74 participants with peanut allergy (ages 4-25\xa0years']","['placebo', 'EPIT', 'peanut epicutaneous immunotherapy (EPIT', 'Epicutaneous immunotherapy', 'Peanut EPIT', 'Viaskin Peanut 100\xa0μg (VP100; n\xa0=\xa024) or Viaskin Peanut 250\xa0μg (VP250; n\xa0=\xa025; DBV Technologies, Montrouge, France']","['reactions, predominantly local patch-site and mild reactions', 'peanut-specific IgG 4  levels and IgG 4 /IgE ratios', 'Treatment success', 'basophil activation and peanut-specific T H 2 cytokines', 'Median change', 'Adverse reactions and mechanistic changes']","[{'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",74.0,0.73914,"Treatment success was higher among younger children (P = .03; age, 4-11 vs ","[{'ForeName': 'Stacie M', 'Initials': 'SM', 'LastName': 'Jones', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark. Electronic address: JonesStacieM@uams.edu.""}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Sicherer', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'A Wesley', 'Initials': 'AW', 'LastName': 'Burks', 'Affiliation': 'Department of Pediatrics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Donald Y M', 'Initials': 'DY', 'LastName': 'Leung', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Lindblad', 'Affiliation': 'EMMES Corporation, Rockville, Md.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'EMMES Corporation, Rockville, Md.'}, {'ForeName': 'Alice K', 'Initials': 'AK', 'LastName': 'Henning', 'Affiliation': 'EMMES Corporation, Rockville, Md.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Berin', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chiang', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Vickery', 'Affiliation': 'Department of Pediatrics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Robbie D', 'Initials': 'RD', 'LastName': 'Pesek', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Cho', 'Affiliation': 'EMMES Corporation, Rockville, Md.'}, {'ForeName': 'Wendy F', 'Initials': 'WF', 'LastName': 'Davidson', 'Affiliation': 'National Institutes of Health (National Institutes of Allergy and Infectious Diseases), Bethesda, Md.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Plaut', 'Affiliation': 'National Institutes of Health (National Institutes of Allergy and Infectious Diseases), Bethesda, Md.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wood', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2016.08.017']
86,25462616,Experiences of stigma and discrimination of people with schizophrenia in India.,"Stigma contributes greatly to the burden of schizophrenia and is a major obstacle to recovery, yet, little is known about the subjective experiences of those directly affected in low and middle income countries. This paper aims to describe the experiences of stigma and discrimination of people living with schizophrenia (PLS) in three sites in India and to identify factors influencing negative discrimination. The study used mixed methods and was nested in a randomised controlled trial of community care for schizophrenia. Between November 2009 and October 2010, data on four aspects of stigma experienced by PLS and several clinical variables were collected from 282 PLS and 282 caregivers and analysed using multivariate regression. In addition, in-depth-interviews with PLS and caregivers (36 each) were carried out and analysed using thematic analysis. Quantitative findings indicate that experiences of negative discrimination were reported less commonly (42%) than more internalised forms of stigma experience such as a sense of alienation (79%) and significantly less often than in studies carried out elsewhere. Experiences of negative discrimination were independently predicted by higher levels of positive symptoms of schizophrenia, lower levels of negative symptoms of schizophrenia, higher caregiver knowledge about symptomatology, lower PLS age and not having a source of drinking water in the home. Qualitative findings illustrate the major impact of stigma on 'what matters most' in the lives of PLS and highlight three key domains influencing the themes of 'negative reactions' and 'negative views and feelings about the self', i.e., 'others finding out', 'behaviours and manifestations of the illness' and 'reduced ability to meet role expectations'. Findings have implications for conceptualising and measuring stigma and add to the rationale for enhancing psycho-social interventions to support those facing discrimination. Findings also highlight the importance of addressing public stigma and achieving higher level social and political structural change.",2014,Quantitative findings indicate that experiences of negative discrimination were reported less commonly (42%) than more internalised forms of stigma experience such as a sense of alienation (79%) and significantly less often than in studies carried out elsewhere.,"['people with schizophrenia in India', 'community care for schizophrenia', 'people living with schizophrenia (PLS']",[],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]",[],[],,0.0410023,Quantitative findings indicate that experiences of negative discrimination were reported less commonly (42%) than more internalised forms of stigma experience such as a sense of alienation (79%) and significantly less often than in studies carried out elsewhere.,"[{'ForeName': 'Mirja', 'Initials': 'M', 'LastName': 'Koschorke', 'Affiliation': ""Centre for Global Mental Health, Institute of Psychiatry, Psychology & Neuroscience, King's College, London, UK. Electronic address: mirja.koschorke@kcl.ac.uk.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Padmavati', 'Affiliation': 'Schizophrenia Research Foundation (SCARF), Chennai, India.'}, {'ForeName': 'Shuba', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Samarth, Chennai, India.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Centre for Global Mental Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sudipto', 'Initials': 'S', 'LastName': 'Chatterjee', 'Affiliation': 'Sangath, Goa, India.'}, {'ForeName': 'Jesina', 'Initials': 'J', 'LastName': 'Pereira', 'Affiliation': 'Sangath, Goa, India.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Naik', 'Affiliation': 'Sangath, Goa, India.'}, {'ForeName': 'Sujit', 'Initials': 'S', 'LastName': 'John', 'Affiliation': 'Schizophrenia Research Foundation (SCARF), Chennai, India.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Dabholkar', 'Affiliation': 'Parivartan, Satara, India.'}, {'ForeName': 'Madhumitha', 'Initials': 'M', 'LastName': 'Balaji', 'Affiliation': 'Sangath, Goa, India.'}, {'ForeName': 'Animish', 'Initials': 'A', 'LastName': 'Chavan', 'Affiliation': 'Nirmittee, Satara, India.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Varghese', 'Affiliation': 'NIMHANS, Bengaluru, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Thara', 'Affiliation': 'Schizophrenia Research Foundation (SCARF), Chennai, India.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""Centre for Global Mental Health, Institute of Psychiatry, Psychology & Neuroscience, King's College, London, UK.""}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Centre for Global Mental Health, London School of Hygiene and Tropical Medicine, London, UK; Sangath, Goa, India.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2014.10.035']
87,30958046,Effect of Environmental Temperature on High-Intensity Intervals in Well-Trained Cyclists.,"PURPOSE


To examine the effect of environmental temperature (TA) on performance and physiological responses (eg, body temperature, cardiopulmonary measures) during a high-intensity aerobic interval session. It was hypothesized that power output would be highest in the 13°C condition and lower in the 5°C, 22°C, and 35°C conditions.
METHODS


Eleven well-trained cyclists randomly completed 4 interval sessions at 5°C, 13°C, 22°C, and 35°C (55% [13%] relative humidity), each involving five 4-min intervals interspersed with 5 min of recovery. During the intervals, power output, core temperature (TC), skin temperature, VO2, and heart rate were recorded.
RESULTS


Mean session power output for 13°C (366 [32] W) was not higher than 5°C (363 [32] W; P = 1.00, effect size = 0.085), 22°C (364 [36] W; P = 1.00, effect size = 0.061), or 35°C (352 [31] W; P = .129, effect size = 0.441). The 5th interval of the 35°C condition had a lower power output compared with all other TA. TC was higher in 22°C compared with both 5°C and 13°C (P = .001). VO2 was not significantly different across TA (P = .187). Heart rate was higher in the 4th and 5th intervals of 35°C compared with 5°C and 13°C.
CONCLUSIONS


This study demonstrates that while mean power outputs for intervals are similar across TA, hot TA (≥35°C) reduces interval power output later in a training session. Well-trained cyclists performing maximal high-intensity aerobic intervals can achieve near-optimal power output over a broader range of TA than previous literature would indicate.",2019,T C  was higher in 22°C compared with both 5°C and 13°C (P= .001).,"['Eleven well-trained cyclists', 'Well-Trained Cyclists']",['environmental temperature (T A '],"['performance and physiological responses (e.g. body temperature and cardiopulmonary measures', 'HR', 'power output, core temperature (T C ), skin temperature, VO 2 , and heart rate (HR', 'T C']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0517519,T C  was higher in 22°C compared with both 5°C and 13°C (P= .001).,"[{'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Boynton', 'Affiliation': ''}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Danner', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Menaspà', 'Affiliation': ''}, {'ForeName': 'Jeremiah J', 'Initials': 'JJ', 'LastName': 'Peiffer', 'Affiliation': ''}, {'ForeName': 'Chris R', 'Initials': 'CR', 'LastName': 'Abbiss', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2018-0689']
88,29524454,"Phase 1 trial of vamorolone, a first-in-class steroid, shows improvements in side effects via biomarkers bridged to clinical outcomes.","BACKGROUND


Glucocorticoid drugs are highly effective anti-inflammatory agents, but chronic use is associated with extensive pharmacodynamic safety concerns that have a considerable negative impact on patient quality of life.
PURPOSE


Vamorolone (VBP15) is a first-in-class steroidal multi-functional drug that shows potent inhibition of pro-inflammatory NFkB pathways via high-affinity binding to the glucocorticoid receptor, high affinity antagonism for the mineralocorticoid receptor, and membrane stabilization properties. Pre-clinical data in multiple mouse models of inflammation showed retention of anti-inflammatory efficacy, but loss of most or all side effects.
EXPERIMENTAL APPROACH


We report first-in-human Phase 1 clinical trials (86 healthy adult males), with single ascending doses (0.1-20.0 mg/kg), and multiple ascending doses (1.0-20 mg/kg/day; 14 days treatment).
KEY RESULTS


Vamorolone was well-tolerated at all dose levels. Vamorolone showed pharmacokinetic and metabolism profiles similar to prednisone. Biomarker studies showed loss of side effects of traditional glucocorticoid drugs (bone fragility, metabolic disturbance, immune suppression). Suppression of the adrenal axis was 10-fold less than prednisone. The crystallographic structure of vamorolone was solved, and compared to prednisone and dexamethasone. There was overlap in structure, but differences in conformation at the C-ring where glucocorticoids interact with Asn564 of the glucocorticoid receptor. The predicted loss of Asn564 binding to vamorolone may underlie the loss of gene transcriptional activity.
CONCLUSIONS AND INTERPRETATIONS


Vamorolone is a dissociative steroid that retains high affinity binding and nuclear translocation of both glucocorticoid (agonist) and mineralocorticoid (antagonist) receptors, but does not show pharmacodynamic safety concerns of existing glucocorticoid drugs at up to 20 mg/kg/day.",2018,Suppression of the adrenal axis was 10-fold less than prednisone.,['86 healthy adult males'],"['prednisone and dexamethasone', 'prednisone', 'vamorolone']","['Suppression of the adrenal axis', 'pharmacokinetic and metabolism profiles', 'tolerated']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",86.0,0.0229825,Suppression of the adrenal axis was 10-fold less than prednisone.,"[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Hoffman', 'Affiliation': 'ReveraGen BioPharma, Rockville, MD, USA; Department of Pharmaceutical Sciences, School of Pharmacy, Binghamton University - SUNY, Binghamton, NY, USA. Electronic address: ericphoffman@gmail.com.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Riddle', 'Affiliation': 'BioPharmAdvisors LLC, USA.'}, {'ForeName': 'Maxime A', 'Initials': 'MA', 'LastName': 'Siegler', 'Affiliation': 'Department of Chemistry, Johns Hopkins University, 3400 N. Charles St., Baltimore, MD 21218 USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dickerson', 'Affiliation': 'PRA Health Sciences, Lenexa, KS, USA.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Backonja', 'Affiliation': 'PRA Health Sciences, Lenexa, KS, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Kramer', 'Affiliation': 'Kramer Consulting LLC, USA.'}, {'ForeName': 'Kanneboyina', 'Initials': 'K', 'LastName': 'Nagaraju', 'Affiliation': 'ReveraGen BioPharma, Rockville, MD, USA; Department of Pharmaceutical Sciences, School of Pharmacy, Binghamton University - SUNY, Binghamton, NY, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gordish-Dressman', 'Affiliation': ""Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Jesse M', 'Initials': 'JM', 'LastName': 'Damsker', 'Affiliation': 'ReveraGen BioPharma, Rockville, MD, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'McCall', 'Affiliation': 'ReveraGen BioPharma, Rockville, MD, USA.'}]",Steroids,['10.1016/j.steroids.2018.02.010']
89,29436624,Clinical verification of Lou type warfarin pharmacokinetic dosing algorithms equation.,"Warfarin is the most commonly used oral anti-coagulant in clinic practice. However, it is difficult to recommend the correct dosage due to its narrow therapeutic window. The aim of the present study was to verify the clinical value of the Lou type equation, using pharmacogenetics‑based warfarin dosing algorithms to appropriately predict the actual maintenance dose. A total of 87 Chinese Han patients who required treatment with warfarin were enrolled and randomly divided into the experimental and control groups. In the experimental group, the first 3 doses of warfarin were calculated according to the Lou type equation. While in the control group, these 3 treatments were performed following the doctors' recommendations. Then the dose of warfarin was gradually adjusted to the stable dose according to the changes in the international standardized ratio. At the end of the 50 day experimental period, there were a greater number of patients in the experimental group who exhibited a stable blood concentration of warfarin than those in the control group (83.35 and 64.4%, respectively). In addition, the mean and median times for patients to obtain a stable dose in the experimental group were significantly shorter than those in the control group (mean, 18.2±1.7 and 27.3±2.0 days; and median, 11.7±1.1 and 20.5±1.8 days, respectively). The adverse reaction rate of the experimental group (9.5%) was markedly lower than that of the control group (26.7%). The occurrence of adverse reactions in the experimental group was also significantly later when compared with the control group (43.9±1.6 and 38.6±1.5 days, respectively). Furthermore, there was no significant difference between the average predicted dose (3.4±1.1 mg/day) and the average actual dose (3.5±1.4 mg/day; P=0.313). In conclusion, using the Lou type warfarin pharmacokinetic dosing algorithm equation to administer warfarin markedly shortened the adjustment time of warfarin to reach a stable dose and reduced the adverse reactions rate, thus supporting clinical feasibility.",2018,The adverse reaction rate of the experimental group (9.5%) was markedly lower than that of the control group (26.7%).,['87\xa0Chinese Han patients who required treatment with'],"['Warfarin', 'warfarin']","['occurrence of adverse reactions', 'adverse reactions rate', 'mean and median times', 'stable blood concentration of warfarin', 'adverse reaction rate']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0641339', 'cui_str': 'HAN(II)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]",,0.020251,The adverse reaction rate of the experimental group (9.5%) was markedly lower than that of the control group (26.7%).,"[{'ForeName': 'Jiangang', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Jinhua Hospital of TCM Affiliated to Zhejiang University of Traditional Chinese Medicine, Jinhua, Zhejiang 321000, P.R. China.'}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'Ji', 'Affiliation': 'Department of Cardiology, Yiwu Central Hospital, Yiwu, Zhejiang 322000, P.R. China.'}, {'ForeName': 'Jingliang', 'Initials': 'J', 'LastName': 'Lan', 'Affiliation': 'Department of Cardiology, Jinhua Hospital of TCM Affiliated to Zhejiang University of Traditional Chinese Medicine, Jinhua, Zhejiang 321000, P.R. China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Ge', 'Affiliation': 'Department of Geriatrics, Zhejiang Jinhua Guangfu Hospital, Jinhua, Zhejiang 321000, P.R. China.'}, {'ForeName': 'Xiaoma', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, Jinhua Hospital of TCM Affiliated to Zhejiang University of Traditional Chinese Medicine, Jinhua, Zhejiang 321000, P.R. China.'}]",Molecular medicine reports,['10.3892/mmr.2018.8562']
90,29287665,Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy.,"BACKGROUND


Tobacco dependence remains the leading preventable cause of death in the developed world. Smokers are disproportionately from lower socioeconomic groups, and may use the hospital emergency department (ED) as an important source of care. A recent clinical trial demonstrated the efficacy of a multicomponent intervention to help smokers quit, but the independent contributions of those components is unknown.
METHODS


This is a full-factorial (16-arm) randomized trial in a busy hospital ED of 4 tobacco dependence interventions: brief motivational interviewing, nicotine replacement therapy, referral to a telephone quitline, and a texting program. The trial utilizes the Multiphase Optimization Strategy (MOST) and a novel mixed methods analytic design to assess clinical efficacy, cost effectiveness, and qualitative participant feedback. The primary endpoint is tobacco abstinence at 3months, verified by participants' exhaled carbon monoxide.
RESULTS


Study enrollment began in February 2017. As of April 2017, 52 of 1056 planned participants (4.9%) were enrolled. Telephone-based semi-structured participant interviews and in-person biochemical verification of smoking abstinence are completed at the 3-month follow-up. Efficacy and cost effectiveness analyses will be conducted after follow-up is completed.
DISCUSSION


The goal of this study is to identify a clinically efficacious, cost-effective intervention package for the initial treatment of tobacco dependence in ED patients. The efficacy of this combination can then be tested in a subsequent confirmatory trial. Our approach incorporates qualitative feedback from study participants in evaluating which intervention components will be tested in the future trial.
TRIAL REGISTRATION


Trial (NCT02896400) registered in ClinicalTrials.gov on September 6, 2016.",2018,"The goal of this study is to identify a clinically efficacious, cost-effective intervention package for the initial treatment of tobacco dependence in ED patients.","['Tobacco dependence treatment in the emergency department', 'As of April 2017, 52 of 1056 planned participants (4.9%) were enrolled', 'Study enrollment began in February 2017', 'tobacco dependence in ED patients']","['Telephone-based semi-structured participant interviews and in-person biochemical verification of smoking abstinence', 'motivational interviewing, nicotine replacement therapy, referral to a telephone quitline, and a texting program', 'multicomponent intervention', 'Multiphase Optimization Strategy (MOST']","['Efficacy and cost effectiveness', 'clinical efficacy, cost effectiveness, and qualitative participant feedback', ""tobacco abstinence at 3months, verified by participants' exhaled carbon monoxide""]","[{'cui': 'C0040332', 'cui_str': 'Tobacco Dependence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",,0.143716,"The goal of this study is to identify a clinically efficacious, cost-effective intervention package for the initial treatment of tobacco dependence in ED patients.","[{'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Bernstein', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, United States; Department of Health Policy, Yale School of Public Health, United States; Yale Cancer Center, New Haven, CT, United States. Electronic address: Steven.bernstein@yale.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, United States; Department of Health Policy, Yale School of Public Health, United States.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Weiss', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, United States.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': 'Pacific Institute of Research and Evaluation, Calverton, MD, United States.'}, {'ForeName': 'Katrina A', 'Initials': 'KA', 'LastName': 'Vickerman', 'Affiliation': 'Alere Wellbeing, Seattle, WA, United States.'}, {'ForeName': 'Lauretta E', 'Initials': 'LE', 'LastName': 'Grau', 'Affiliation': 'Department of Health Policy, Yale School of Public Health, United States.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, United States.'}, {'ForeName': 'Lorien', 'Initials': 'L', 'LastName': 'Abroms', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health at George Washington University, United States.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Collins', 'Affiliation': 'The Methodology Center and Department of Human Development and Family Studies, Pennsylvania State University, College Station, PA, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Toll', 'Affiliation': 'Yale Cancer Center, New Haven, CT, United States; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2017.12.016']
91,29109107,Web-based Social Media Intervention to Increase Vaccine Acceptance: A Randomized Controlled Trial.,"BACKGROUND


Interventions to address vaccine hesitancy and increase vaccine acceptance are needed. This study sought to determine if a Web-based, social media intervention increases early childhood immunization.
METHODS


A 3-arm, randomized controlled trial was conducted in Colorado from September 2013 to July 2016. Participants were pregnant women, randomly assigned (3:2:1) to a Web site with vaccine information and interactive social media components (VSM), a Web site with vaccine information (VI), or usual care (UC). Vaccination was assessed in infants of participants from birth to age 200 days. The primary outcome was days undervaccinated, measured as a continuous and dichotomous variable.
RESULTS


Infants of 888 participants were managed for 200 days. By using a nonparametric rank-based analysis, mean ranks for days undervaccinated were significantly lower in the VSM arm versus UC ( P  = .02) but not statistically different between the VI and UC ( P  = .08) or between VSM and VI arms ( P  = .63). The proportions of infants up-to-date at age 200 days were 92.5, 91.3, and 86.6 in the VSM, VI, and UC arms, respectively. Infants in the VSM arm were more likely to be up-to-date than infants in the UC arm (odds ratio [OR] = 1.92; 95% confidence interval [CI], 1.07-3.47). Up-to-date status was not statistically different between VI and UC arms (OR = 1.62; 95% CI, 0.87-3.00) or between the VSM and VI arms (OR = 1.19, 95% CI, 0.70-2.03).
CONCLUSIONS


Providing Web-based vaccine information with social media applications during pregnancy can positively influence parental vaccine behaviors.",2017,"Up-to-date status was not statistically different between VI and UC arms (OR = 1.62; 95% CI, 0.87-3.00) or between the VSM and VI arms (OR = 1.19, 95% CI, 0.70-2.03).
","['Participants were pregnant women', 'Infants of 888 participants were managed for 200 days', 'infants of participants from birth to age 200 days', 'Colorado from September 2013 to July 2016']","['Web-based Social Media Intervention', 'social media intervention', 'vaccine information and interactive social media components (VSM), a Web site with vaccine information (VI), or usual care (UC']","['Vaccination', 'Vaccine Acceptance']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]",888.0,0.309915,"Up-to-date status was not statistically different between VI and UC arms (OR = 1.62; 95% CI, 0.87-3.00) or between the VSM and VI arms (OR = 1.19, 95% CI, 0.70-2.03).
","[{'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Glanz', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado; jason.m.glanz@kp.org.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Komal J', 'Initials': 'KJ', 'LastName': 'Narwaney', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Kraus', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Jo Ann', 'Initials': 'JA', 'LastName': 'Shoup', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado; and.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Gleason', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Daley', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}]",Pediatrics,['10.1542/peds.2017-1117']
92,29802967,Engendering healthy masculinities to prevent sexual violence: Rationale for and design of the Manhood 2.0 trial.,"Violence against women and girls is an important global health concern. Numerous health organizations highlight engaging men and boys in preventing violence against women as a potentially impactful public health prevention strategy. Adapted from an international setting for use in the US, ""Manhood 2.0"" is a ""gender transformative"" program that involves challenging harmful gender and sexuality norms that foster violence against women while promoting bystander intervention (i.e., giving boys skills to interrupt abusive behaviors they witness among peers) to reduce the perpetration of sexual violence (SV) and adolescent relationship abuse (ARA). Manhood 2.0 is being rigorously evaluated in a community-based cluster-randomized trial in 21 lower resource Pittsburgh neighborhoods with 866 adolescent males ages 13-19. The comparison intervention is a job readiness training program which focuses on the skills needed to prepare youth for entering the workforce, including goal setting, accountability, resume building, and interview preparation. This study will provide urgently needed information about the effectiveness of a gender transformative program, which combines healthy sexuality education, gender norms change, and bystander skills to interrupt peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among adolescent males. In this manuscript, we outline the rationale for and evaluation design of Manhood 2.0. Clinical Trials #: NCT02427061.",2018,"The comparison intervention is a job readiness training program which focuses on the skills needed to prepare youth for entering the workforce, including goal setting, accountability, resume building, and interview preparation.","['adolescent males', 'Violence against women and girls', '21 lower resource Pittsburgh neighborhoods with 866 adolescent males ages 13-19']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],[],21.0,0.0320794,"The comparison intervention is a job readiness training program which focuses on the skills needed to prepare youth for entering the workforce, including goal setting, accountability, resume building, and interview preparation.","[{'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh School of Medicine, 200 Meyran Ave., Suite 300, Pittsburgh, PA 15213, USA. Electronic address: kza3@pitt.edu.'}, {'ForeName': 'Kelley A', 'Initials': 'KA', 'LastName': 'Jones', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Culyba', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Nayck B', 'Initials': 'NB', 'LastName': 'Feliz', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Anderson', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Torres', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Zelazny', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bamwine', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Adwoa', 'Initials': 'A', 'LastName': 'Boateng', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Cirba', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Detchon', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Devine', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Feinstein', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Macak', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Massof', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Miller-Walfish', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Sarah Elizabeth', 'Initials': 'SE', 'LastName': 'Morrow', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mulbah', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Zabi', 'Initials': 'Z', 'LastName': 'Mulwa', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Paglisotti', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ripper', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Ports', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway, Atlanta, GA 30341, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Matjasko', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway, Atlanta, GA 30341, USA.'}, {'ForeName': 'Aapta', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'Promundo-US, 1367 Connecticut Avenue, NW, Suite #310, Washington, DC 20036, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kato-Wallace', 'Affiliation': 'Promundo-US, 1367 Connecticut Avenue, NW, Suite #310, Washington, DC 20036, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Pulerwitz', 'Affiliation': 'Population Council, 4301 Connecticut Avenue, NW, Suite 280, Washington, DC 20008, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, Department of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Ave, Pittsburgh, PA 15213, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2018.05.017']
93,28216644,Infant adiposity following a randomised controlled trial of a behavioural intervention in obese pregnancy.,"OBJECTIVES


Randomised controlled trials are required to address causality in the reported associations between maternal influences and offspring adiposity. The aim of this study was to determine whether an antenatal lifestyle intervention, associated with improvements in maternal diet and reduced gestational weight gain (GWG) in obese pregnant women leads to a reduction in infant adiposity and sustained improvements in maternal lifestyle behaviours at 6 months postpartum.
SUBJECTS AND METHODS


We conducted a planned postnatal follow-up of a randomised controlled trial (UK Pregnancies Better Eating and Activity Trial (UPBEAT)) of a complex behavioural intervention targeting maternal diet (glycaemic load (GL) and saturated fat intake) and physical activity in 1555 obese pregnant women. The main outcome measure was infant adiposity, assessed by subscapular and triceps skinfold thicknesses. Maternal diet and physical activity, indices of the familial lifestyle environment, were assessed by questionnaire.
RESULTS


A total of 698 (45.9%) infants (342 intervention and 356 standard antenatal care) were followed up at a mean age of 5.92 months. There was no difference in triceps skinfold thickness z-scores between the intervention vs standard care arms (difference -0.14 s.d., 95% confidence interval -0.38 to 0.10, P=0.246), but subscapular skinfold thickness z-score was 0.26 s.d. (-0.49 to -0.02; P=0.03) lower in the intervention arm. Maternal dietary GL (-35.34; -48.0 to -22.67; P<0.001) and saturated fat intake (-1.93% energy; -2.64 to -1.22; P<0.001) were reduced in the intervention arm at 6 months postpartum. Causal mediation analysis suggested that lower infant subscapular skinfold thickness was partially mediated by changes in antenatal maternal diet and GWG rather than postnatal diet.
CONCLUSIONS


This study provides evidence from follow-up of a randomised controlled trial that a maternal behavioural intervention in obese pregnant women has the potential to reduce infant adiposity and to produce a sustained improvement in maternal diet at 6 months postpartum.",2017,Maternal dietary GL (-35.34; -48.0 to -22.67; P<0.001) and saturated fat intake (-1.93% energy; -2.64 to -1.22; P<0.001) were reduced in the intervention arm at 6 months postpartum.,"['A total of 698 (45.9%) infants (342 intervention and 356 standard antenatal care', '1555 obese pregnant women', 'obese pregnant women', 'obese pregnancy']","['behavioural intervention', 'antenatal lifestyle intervention', 'maternal behavioural intervention', 'complex behavioural intervention targeting maternal diet (glycaemic load (GL) and saturated fat intake']","['subscapular skinfold thickness z-score', 'maternal lifestyle behaviours', 'Maternal dietary GL', 'saturated fat intake', 'Maternal diet and physical activity, indices of the familial lifestyle environment', 'gestational weight gain (GWG', 'infant adiposity, assessed by subscapular and triceps skinfold thicknesses', 'triceps skinfold thickness z-scores']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0556120', 'cui_str': 'Saturated fat intake (observable entity)'}]","[{'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0556120', 'cui_str': 'Saturated fat intake (observable entity)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}]",1555.0,0.22254,Maternal dietary GL (-35.34; -48.0 to -22.67; P<0.001) and saturated fat intake (-1.93% energy; -2.64 to -1.22; P<0.001) were reduced in the intervention arm at 6 months postpartum.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': ""Division of Women's Health, Women's Health Academic Centre, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.""}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit and NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pasupathy', 'Affiliation': ""Division of Women's Health, Women's Health Academic Centre, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Flynn', 'Affiliation': ""Division of Women's Health, Women's Health Academic Centre, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Briley', 'Affiliation': ""Division of Women's Health, Women's Health Academic Centre, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bell', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Lawlor', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol and School of Social and Community Medicine, Bristol, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Oteng-Ntim', 'Affiliation': ""Department of Obstetrics and Gynaecology, Guys and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Nelson', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Robson', 'Affiliation': 'Institute of Cellular Medicine Uterine Cell Signalling Group Newcastle University, Newcastle, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Singh', 'Affiliation': ""Department of Obstetrics and Gynaecology, Guys and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wardle', 'Affiliation': 'Health Behaviour Research Centre, Institute of Epidemiology and Health, University College London, London, UK.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'White', 'Affiliation': ""Division of Women's Health, Women's Health Academic Centre, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.""}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Division of Women's Health, Women's Health Academic Centre, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Division of Women's Health, Women's Health Academic Centre, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.""}]",International journal of obesity (2005),['10.1038/ijo.2017.44']
94,19619331,Importin-13 genetic variation is associated with improved airway responsiveness in childhood asthma.,"BACKGROUND


Glucocorticoid function is dependent on efficient translocation of the glucocorticoid receptor (GR) from the cytoplasm to the nucleus of cells. Importin-13 (IPO13) is a nuclear transport receptor that mediates nuclear entry of GR. In airway epithelial cells, inhibition of IPO13 expression prevents nuclear entry of GR and abrogates anti-inflammatory effects of glucocorticoids. Impaired nuclear entry of GR has been documented in steroid-non-responsive asthmatics. We hypothesize that common IPO13 genetic variation influences the anti-inflammatory effects of inhaled corticosteroids for the treatment of asthma, as measured by change in methacholine airway hyperresponsiveness (AHR-PC20).
METHODS


10 polymorphisms were evaluated in 654 children with mild-to-moderate asthma participating in the Childhood Asthma Management Program (CAMP), a clinical trial of inhaled anti-inflammatory medications (budesonide and nedocromil). Population-based association tests with repeated measures of PC20 were performed using mixed models and confirmed using family-based tests of association.
RESULTS


Among participants randomized to placebo or nedocromil, IPO13 polymorphisms were associated with improved PC20 (i.e. less AHR), with subjects harboring minor alleles demonstrating an average 1.51-2.17 fold increase in mean PC20 at 8-months post-randomization that persisted over four years of observation (p = 0.01-0.005). This improvement was similar to that among children treated with long-term inhaled corticosteroids. There was no additional improvement in PC20 by IPO13 variants among children treated with inhaled corticosteroids.
CONCLUSION


IPO13 variation is associated with improved AHR in asthmatic children. The degree of this improvement is similar to that observed with long-term inhaled corticosteroid treatment, suggesting that IPO13 variation may improve nuclear bioavailability of endogenous glucocorticoids.",2009,"In airway epithelial cells, inhibition of IPO13 expression prevents nuclear entry of GR and abrogates anti-inflammatory effects of glucocorticoids.","['10 polymorphisms were evaluated in 654 children with mild-to-moderate asthma participating in the Childhood Asthma Management Program (CAMP), a clinical trial of inhaled anti-inflammatory medications ', 'asthmatic children', 'childhood asthma']","['placebo or nedocromil', 'budesonide and nedocromil']","['improved PC20', 'PC20', 'mean PC20']","[{'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma (disorder)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068483', 'cui_str': 'Nedocromil'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",654.0,0.0722291,"In airway epithelial cells, inhibition of IPO13 expression prevents nuclear entry of GR and abrogates anti-inflammatory effects of glucocorticoids.","[{'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Raby', 'Affiliation': ""Channing Laboratory, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA. rebar@channing.harvard.edu""}, {'ForeName': 'Kristel', 'Initials': 'K', 'LastName': 'Van Steen', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lasky-Su', 'Affiliation': ''}, {'ForeName': 'Kelan', 'Initials': 'K', 'LastName': 'Tantisira', 'Affiliation': ''}, {'ForeName': 'Feige', 'Initials': 'F', 'LastName': 'Kaplan', 'Affiliation': ''}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ''}]",Respiratory research,['10.1186/1465-9921-10-67']
95,21945107,Whole-pelvis or bladder-only chemoradiation for lymph node-negative invasive bladder cancer: single-institution experience.,"PURPOSE


Whole-pelvis (WP) concurrent chemoradiation (CCRT) is the standard bladder preserving option for patients with invasive bladder cancer. The standard practice is to treat elective pelvic lymph nodes, so our aim was to evaluate whether bladder-only (BO) CCRT leads to results similar to those obtained by standard WP-CCRT.
METHODS AND MATERIALS


Patient eligibility included histopathologically proven muscle-invasive bladder cancer, lymph nodes negative (T2-T4, N-) by radiology, and maximal transurethral resection of bladder tumor with normal hematologic, renal, and liver functions. Between March 2005 and May 2006, 230 patients were accrued. Patients were randomly assigned to WP-CCRT (120 patients) and BO-CCRT (110 patients). Data regarding the toxicity profile, compliance, initial complete response rates at 3 months, and occurrence of locoregional or distant failure were recorded.
RESULTS


With a median follow-up time of 5 years (range, 3-6), WP-CCRT was associated with a 5-year disease-free survival of 47.1% compared with 46.9% in patients treated with BO-CCRT (p = 0.5). The bladder preservation rates were 58.9% and 57.1% in WP-CCRT and BO-CCRT, respectively (p = 0.8), and the 5-year overall survival rates were 52.9% for WP-CCRT and 51% for BO-CCRT (p = 0.8).
CONCLUSION


BO-CCRT showed similar rates of bladder preservation, disease-free survival, and overall survival rates as those of WP-CCRT. Smaller field sizes including bladder with 2-cm margins can be used as bladder preservation protocol for patients with muscle-invasive lymph node-negative bladder cancer to minimize the side effects of CCRT.",2012,"The bladder preservation rates were 58.9% and 57.1% in WP-CCRT and BO-CCRT, respectively (p = 0.8), and the 5-year overall survival rates were 52.9% for WP-CCRT and 51% for BO-CCRT (p = 0.8).
","['Between March 2005 and May 2006, 230 patients were accrued', 'lymph node-negative invasive bladder cancer', 'Patient eligibility included histopathologically proven muscle-invasive bladder cancer, lymph nodes negative (T2-T4, N-) by radiology, and maximal transurethral resection of bladder tumor with normal hematologic, renal, and liver functions', 'patients with invasive bladder cancer', 'patients with muscle-invasive lymph node-negative bladder cancer']","['WP-CCRT', 'Whole-pelvis or bladder-only chemoradiation', 'Whole-pelvis (WP) concurrent chemoradiation (CCRT']","['bladder preservation rates', 'rates of bladder preservation, disease-free survival, and overall survival rates', '5-year overall survival rates', 'occurrence of locoregional or distant failure', 'toxicity profile, compliance, initial complete response rates', '5-year disease-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",230.0,0.0684967,"The bladder preservation rates were 58.9% and 57.1% in WP-CCRT and BO-CCRT, respectively (p = 0.8), and the 5-year overall survival rates were 52.9% for WP-CCRT and 51% for BO-CCRT (p = 0.8).
","[{'ForeName': 'Mutahir A', 'Initials': 'MA', 'LastName': 'Tunio', 'Affiliation': 'Department of Radiation Oncology, Sindh Institute of Urology & Transplantation, Karachi, Pakistan. drmutahirtonio@hotmail.com'}, {'ForeName': 'Altaf', 'Initials': 'A', 'LastName': 'Hashmi', 'Affiliation': ''}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Qayyum', 'Affiliation': ''}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Mohsin', 'Affiliation': ''}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zaeem', 'Affiliation': ''}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2011.05.051']
96,31560051,Effectiveness of Oral Vancomycin for Prevention of Healthcare Facility-Onset Clostridioides difficile Infection in Targeted Patients During Systemic Antibiotic Exposure.,"BACKGROUND


Limited retrospective data suggest prophylactic oral vancomycin may prevent Clostridioides difficile infection (CDI). We sought to evaluate the effectiveness of oral vancomycin for the prevention of healthcare facility-onset CDI (HCFO-CDI) in targeted patients.
METHODS


We conducted a randomized, prospective, open-label study at Novant Health Forsyth Medical Center in Winston-Salem, North Carolina, between October 2018 and April 2019. Included patients were randomized 1:1 to either oral vancomycin (dosed at 125 mg once daily while receiving systemic antibiotics and continued for 5 days postcompletion of systemic antibiotics [OVP]) or no prophylaxis. The primary endpoint was incidence of HCFO-CDI. Secondary endpoints included incidence of community-onset healthcare facility-associated CDI (CO-HCFA-CDI), incidence of vancomycin-resistant Enterococci (VRE) colonization after receiving OVP, adverse effects, and cost of OVP.
RESULTS


A total of 100 patients were evaluated, 50 patients in each arm. Baseline and hospitalization characteristics were similar, except antibiotic exposure. No events of HCFO-CDI were noted in the OVP group compared with 6 (12%) in the no-prophylaxis group (P = .03). CO-HCFA-CDI was identified in 2 patients who were previously diagnosed with HCFO-CDI. No patients developed new VRE colonization, with only 1 patient reporting mild gastrointestinal side effects to OVP. A total of 600 doses of OVP were given during the study, with each patient receiving an average of 12 doses. Total acquisition cost of OVP was $1302, $26.04 per patient.
CONCLUSION


OVP appears to protect against HCFO-CDI during in-patient stay in targeted patients during systemic antibiotic exposure. Further prospective investigation is warranted.",2020,No events of HCFO-CDI were noted in the OVP group compared to 6 (12%) in the no prophylaxis group (p = 0.03).,"['Novant Health Forsyth Medical Center in Winston-Salem, North Carolina between October 2018 and April 2019', 'targeted patients', 'A total of 100 patients were evaluated, 50 patients in each arm', '2 patients who were previously diagnosed with HCFO-CDI', 'Targeted Patients']","['OVP', 'vancomycin', 'Oral Vancomycin', 'oral vancomycin', 'systemic antibiotics [OVP]), or no prophylaxis']","['new VRE colonization', 'HCFO-CDI', 'Baseline and hospitalization characteristics', 'incidence of HCFO-CDI', 'Total acquisition cost of OVP', 'incidence of community-onset healthcare facility-associated CDI (CO-HCFA-CDI), incidence of vancomycin-resistant Enterococci (VRE) colonization after receiving OVP, adverse effects and cost of OVP', 'CO-HCFA-CDI']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0041718', 'cui_str': 'Health Care Financing Administration'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",100.0,0.103606,No events of HCFO-CDI were noted in the OVP group compared to 6 (12%) in the no prophylaxis group (p = 0.03).,"[{'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Johnson', 'Affiliation': 'Department of Pharmacy Practice, Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina, USA.'}, {'ForeName': 'Shannon V', 'Initials': 'SV', 'LastName': 'Brown', 'Affiliation': 'Department of Pharmacy Practice, Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Priest', 'Affiliation': 'Novant Health Institute for Safety and Quality, Winston-Salem, North Carolina, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz966']
97,26264737,"Using IT to improve access, communication, and asthma in African American and Hispanic/Latino Adults: Rationale, design, and methods of a randomized controlled trial.","Asthma morbidity is high among inner-city minority adults. Improving access to care and patient-provider communication are believed to be essential for improving outcomes. Access and communication in turn increasingly rely on information technology including features of the Electronic Health Record. Its patient portal offers web-based communication with providers and practices. How patients with limited resources and educational opportunities can benefit from this portal is unclear. In contrast, home visits by community health workers (CHWs) have improved access to care for asthmatic children and promoted caretaker-clinician communication. We describe the planning, design, and methodology of an ongoing randomized controlled trial for 300 adults, predominantly African American and Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods who are directed to the most convenient internet access and taught to use the portal, with and without home visits from a CHW. The study 1) compares the effects of the 1-year interventions on asthma outcomes (improved asthma control, quality of life; fewer ED visits and hospitalizations for asthma or any cause), 2) evaluates whether communication (portal use) and access (appointments made/kept) mediate the interventions' effects on asthma outcomes, and 3) investigates effect modification by literacy level, primary language, and convenience of internet access. In home visits, CHWs 1) train patients to competency in portal use, 2) enhance care coordination, 3) communicate the complex social circumstances of patients' lives to providers, and 4) compensate for differences in patients' health literacy skills. The practical challenges to design and implementation in the targeted population are presented.",2015,"The study 1) compares the effects of the 1-year interventions on asthma outcomes (improved asthma control, quality of life; fewer ED visits and hospitalizations for asthma or any cause), 2) evaluates whether communication (portal use) and access (appointments made/kept) mediate the interventions' effects on asthma outcomes, and 3) investigates effect modification by literacy level, primary language, and convenience of internet access.","['300 adults, predominantly African American and Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods who are directed to the most convenient internet access and taught to use the portal, with and without home visits from a CHW', 'African American and Hispanic/Latino Adults']",[],"[""asthma outcomes (improved asthma control, quality of life; fewer ED visits and hospitalizations for asthma or any cause), 2) evaluates whether communication (portal use) and access (appointments made/kept) mediate the interventions' effects on asthma outcomes, and 3) investigates effect modification by literacy level, primary language, and convenience of internet access"", 'Asthma morbidity']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3831015', 'cui_str': 'Convenient (qualifier value)'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}]",[],"[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",300.0,0.0489165,"The study 1) compares the effects of the 1-year interventions on asthma outcomes (improved asthma control, quality of life; fewer ED visits and hospitalizations for asthma or any cause), 2) evaluates whether communication (portal use) and access (appointments made/kept) mediate the interventions' effects on asthma outcomes, and 3) investigates effect modification by literacy level, primary language, and convenience of internet access.","[{'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Apter', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine; Department of Medicine, 3400 Spruce St, Philadelphia, PA 19104, United States; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States; University of Pennsylvania Health System, Philadelphia, Pennsylvania, United States. Electronic address: apter@mail.med.upenn.edu.'}, {'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Bryant-Stephens', 'Affiliation': ""Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States; Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Knashawn H', 'Initials': 'KH', 'LastName': 'Morales', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States; Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wan', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States; Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Sharmaine', 'Initials': 'S', 'LastName': 'Hardy', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Shakira', 'Initials': 'S', 'LastName': 'Reed-Wells', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dominguez', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Rodalyn', 'Initials': 'R', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine; Department of Medicine, 3400 Spruce St, Philadelphia, PA 19104, United States; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'NaDea', 'Initials': 'N', 'LastName': 'Mak', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Nardi', 'Affiliation': 'Temple Physicians, Inc., Temple University Health System, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Hami', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'School of Arts and Sciences, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Howell', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States; University of Pennsylvania Health System, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Localio', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States; Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2015.08.001']
98,32430334,Polygenic risk for skin autoimmunity impacts immune checkpoint blockade in bladder cancer.,"PD-1 and PD-L1 act to restrict T cell responses in cancer and contribute to self-tolerance. Consistent with this role, PD-1 checkpoint inhibitors have been associated with immune-related adverse events (irAEs), immune toxicities thought to be autoimmune in origin. Analyses of dermatological irAEs have identified an association with improved overall survival (OS) following anti-PD-(L)1 therapy, but the factors that contribute to this relationship are poorly understood. We collected germline whole-genome sequencing data from IMvigor211, a recent phase 3 randomized controlled trial comparing atezolizumab (anti-PD-L1) monotherapy to chemotherapy in bladder cancer. We found that high vitiligo, high psoriasis, and low atopic dermatitis polygenic risk scores (PRSs) were associated with longer OS under anti-PD-L1 monotherapy as compared to chemotherapy, reflecting the Th17 polarization of these diseases. PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures. Shared genetic factors impact risk for dermatological autoimmunity and anti-PD-L1 monotherapy in bladder cancer.",2020,"PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures.",['bladder cancer'],['atezolizumab (anti-PD-L1) monotherapy'],"['overall survival (OS', 'low atopic dermatitis polygenic risk scores (PRSs']","[{'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0526833,"PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures.","[{'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Di Nucci', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Kwan', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hammer', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mariathasan', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Rouilly', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Fontes', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Ley Acosta', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Guardino', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Haiyin', 'Initials': 'H', 'LastName': 'Chen-Harris', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Bhangale', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Mellman', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, EC1M 6BQ London, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hunkapiller', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'G Scott', 'Initials': 'GS', 'LastName': 'Chandler', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Albert', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1922867117']
99,31537473,"Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2-3 trial.","BACKGROUND


Late radiation cystitis is an adverse effect of cancer treatment with radiotherapy in the pelvic region. Symptoms of late radiation cystitis can be assessed with the Expanded Prostate Index Composite Score (EPIC). Previous reports indicate that hyperbaric oxygen therapy reduces symptoms from late radiation cystitis, but the evidence is predominantly based on non-randomised and retrospective studies. We aimed to assess whether hyperbaric oxygen therapy would mitigate symptoms of late radiation cystitis.
METHODS


We did a randomised, controlled, phase 2-3 trial (RICH-ART [Radiation Induced Cystitis treated with Hyperbaric oxygen-A Randomised controlled Trial]) at five Nordic university hospitals. All patients aged 18-80 years, with pelvic radiotherapy completed at least 6 months previously, a score of less than 80 in the urinary domain of the Expanded Prostate Index Composite Score (EPIC), and referred to participating hyperbaric clinics due to symptoms of late radiation cystitis, were eligible for inclusion. Exclusion criteria were ongoing bleeding requiring blood transfusion exceeding 500 mL in the past 4 weeks, permanent urinary catheter, bladder capacity less than 100 mL, fistula in the urinary bladder, previous treatment with hyperbaric oxygen therapy for late radiation injuries, and contraindications to hyperbaric oxygen therapy. After computer-generated 1:1 randomisation with block sizes of four for each stratification group (sex, time from radiotherapy to inclusion, and previous invasive surgery in the pelvic area), patients received hyperbaric oxygen therapy (30-40 sessions, 100% oxygen, breathed at a pressure of 240-250 kPa, for 80-90 min daily) or standard care with no restrictions for other medications or interventions. No masking was applied. The primary outcome was change in patient-perceived urinary symptoms assessed with EPIC from inclusion to follow-up at visit 4 (6-8 months later), measured as absolute change in EPIC urinary total score. RICH-ART closed enrolment on Dec 31, 2017; the last follow-up data will be compiled in 2023. RICH-ART is registered with ClinicalTrials.gov, number NCT01659723, and with the European Medicines Agency, number EudraCT 2012-001381-15.
FINDINGS


Of 223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients were enrolled and randomly assigned to either hyperbaric oxygen therapy (n=42) or standard care (n=45). After excluding eight patients who withdrew consent directly after randomisation (one in the hyperbaric oxygen therapy group and seven in the standard care group), 79 were included in the intention-to-treat analyses (n=41 in the hyperbaric oxygen therapy group, n=38 in the standard care group). Median time from randomisation to visit 4 was 234 days (IQR 210-262) in the hyperbaric oxygen therapy group and 217 days (195-237) in the standard care group. The difference between change in group mean of EPIC urinary total score at visit 4 was 10·1 points (95% CI 2·2-18·1; p=0·013; 17·8 points [SD 18·4] in the hyperbaric oxygen therapy group vs 7·7 points [15·5] in the standard care group). 17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy.
INTERPRETATION


Our results suggest that hyperbaric oxygen therapy relieves symptoms of late radiation cystitis. We conclude that hyperbaric oxygen therapy is a safe and well tolerated treatment.
FUNDING


The regional research fund of Region Västra Götaland, Sweden, the regional Health Technology Assessment Centre at Sahlgrenska University Hospital, Sweden, and Lions Cancer Research Fund of Western Sweden.",2019,"17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy.
","['n=42) or standard care (n=45', 'group and seven in the standard care group), 79 were included in the intention-to-treat analyses (n=41 in the hyperbaric oxygen therapy group, n=38 in the standard care group', 'All patients aged 18-80 years, with pelvic radiotherapy completed at least 6 months previously, a score of less than 80 in the urinary domain of the Expanded Prostate Index Composite Score (EPIC), and referred to participating hyperbaric clinics due to symptoms of late radiation cystitis, were eligible for inclusion', '223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients', 'five Nordic university hospitals']","['hyperbaric oxygen therapy', 'hyperbaric oxygen therapy (30-40 sessions, 100% oxygen, breathed at a pressure of 240-250 kPa, for 80-90 min daily) or standard care with no restrictions for other medications or interventions', 'Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART', 'RICH-ART [Radiation Induced Cystitis treated with Hyperbaric oxygen', 'radiotherapy']","['symptoms of late radiation cystitis', 'Symptoms of late radiation cystitis', 'Expanded Prostate Index Composite Score (EPIC', 'Median time', 'transient grade 1-2 adverse events, related to sight and hearing', 'change in patient-perceived urinary symptoms assessed with EPIC', 'EPIC urinary total score', 'absolute change in EPIC urinary total score']","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0436385', 'cui_str': 'Radiotherapy completed'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0156270', 'cui_str': 'Irradiation cystitis (disorder)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439474', 'cui_str': 'kPa'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0156270', 'cui_str': 'Irradiation cystitis (disorder)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",79.0,0.156227,"17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy.
","[{'ForeName': 'Nicklas', 'Initials': 'N', 'LastName': 'Oscarsson', 'Affiliation': 'Angereds Närsjukhus, Angered, Sweden; Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden. Electronic address: nicklas.oscarsson@vgregion.se.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Müller', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Occupational Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Rosén', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pär', 'Initials': 'P', 'LastName': 'Lodding', 'Affiliation': 'Department of Urology, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mölne', 'Affiliation': 'Department of Pathology and Genetics, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Giglio', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Hjelle', 'Affiliation': 'Department of Urology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Guro', 'Initials': 'G', 'LastName': 'Vaagbø', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Occupational Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hyldegaard', 'Affiliation': 'Department of Anaesthesia and Surgery, Hyperbaric Unit, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vangedal', 'Affiliation': 'Department of Urology, Herlev-Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Salling', 'Affiliation': 'Department of Urology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kjellberg', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Folke', 'Initials': 'F', 'LastName': 'Lind', 'Affiliation': 'Department of Physiology and Pharmacology, Section for Anaesthesiology and Intensive Care Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Ettala', 'Affiliation': 'Department of Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Arola', 'Affiliation': 'Department of Anaesthesiology and Intensive, University of Turku, Turku, Finland.'}, {'ForeName': 'Helén', 'Initials': 'H', 'LastName': 'Seeman-Lodding', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30494-2']
100,32431251,Can the PROPER intervention reduce psychotropic drug prescription in nursing home residents with dementia? Results of a cluster-randomized controlled trial.,"OBJECTIVES


To evaluate the effect of the PROPER intervention in nursing home residents with dementia on the prevalence of psychotropic drug use and neuropsychiatric symptoms.
DESIGN


A cluster-randomized controlled design with two parallel groups (intervention versus usual care) and assessments at 0, 6, 12, and 18 months.
SETTING


Thirty-one dementia special care units within 13 long-term care organizations in the Netherlands.
PARTICIPANTS


Three hundred eighty nursing home residents with dementia.
INTERVENTION


The PROPER intervention consisted of a structured and repeated multidisciplinary medication review, supported by education and continuous evaluation.
MEASUREMENTS


Prescriptions of antipsychotics, antidepressants, anxiolytics, and hypnotics, and occurrence of neuropsychiatric symptoms.
RESULTS


The prescription of any type of psychotropic drugs increased in the intervention group, and decreased in the control group, with an estimated difference of 3.9 percentage points per 6 months (p = 0.01). Effects for the individual drug groups were minor (differences of 1.6 percentage points and below per 6 months) and not statistically significant. The occurrence of neuropsychiatric symptoms remained stable in both the intervention and control groups during the follow-up of 18 months.
CONCLUSIONS


The PROPER intervention failed to demonstrate effectiveness in reducing the prevalence of psychotropic drugs. It may be interesting to enrich the intervention with components that address personal attitudes and communication between nursing home professionals, not only with respect to the prescription of psychotropic drugs, but also to neuropsychiatric symptoms.The study has been registered in The Netherlands Trial Register (NTR3569).",2021,"The occurrence of neuropsychiatric symptoms remained stable in both the intervention and control groups during the follow-up of 18 months.
","['Thirty-one dementia special care units within 13 long-term care organizations in the Netherlands', 'nursing home residents with dementia on the prevalence of psychotropic drug use and neuropsychiatric symptoms', 'nursing home residents with dementia', 'Three hundred eighty nursing home residents with dementia']",['PROPER intervention'],"['prescription of any type of psychotropic drugs', 'Prescriptions of antipsychotics, antidepressants, anxiolytics, and hypnotics, and occurrence of neuropsychiatric symptoms', 'occurrence of neuropsychiatric symptoms']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0558600', 'cui_str': 'Special care unit'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}]",,0.0487555,"The occurrence of neuropsychiatric symptoms remained stable in both the intervention and control groups during the follow-up of 18 months.
","[{'ForeName': 'C H W', 'Initials': 'CHW', 'LastName': 'Smeets', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud University Medical Center Alzheimer Center, Nijmegen, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Smalbrugge', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam UMC, location VUmc / Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'R T C M', 'Initials': 'RTCM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud University Medical Center Alzheimer Center, Nijmegen, the Netherlands.'}, {'ForeName': 'M H J M G', 'Initials': 'MHJMG', 'LastName': 'Nelissen-Vrancken', 'Affiliation': 'Dutch Institute for Rational Use of Medicine, Utrecht, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'van der Spek', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud University Medical Center Alzheimer Center, Nijmegen, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Teerenstra', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Health Evidence, section Biostatistics, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud University Medical Center Alzheimer Center, Nijmegen, the Netherlands.'}, {'ForeName': 'S U', 'Initials': 'SU', 'LastName': 'Zuidema', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]",International psychogeriatrics,['10.1017/S1041610220000629']
101,31744825,"Comment on 'Sustained discontinuation of infliximab with a raising-dose strategy after obtaining remission in patients with rheumatoid arthritis: the RRRR study, a randomised controlled trial' by Tanaka  et al .",,2021,,['patients with rheumatoid arthritis'],['infliximab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}]",[],,0.060845,,"[{'ForeName': 'Lea C', 'Initials': 'LC', 'LastName': 'Berkhout', 'Affiliation': 'Immunopathology, Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Merel J', 'Initials': 'MJ', 'LastName': ""l'Ami"", 'Affiliation': 'Reade, Amsterdam Rheumatology and immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerrit Jan', 'Initials': 'GJ', 'LastName': 'Wolbink', 'Affiliation': 'Immunopathology, Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Rispens', 'Affiliation': 'Immunopathology, Sanquin Research, Amsterdam, The Netherlands t.rispens@sanquin.nl.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216557']
102,31452471,Implementing a multidisciplinary psychotropic medication review among nursing home residents with dementia: a process evaluation.,"OBJECTIVES


Before drawing conclusions on the contribution of an effective intervention to daily practice and initiating dissemination, its quality and implementation in daily practice should be optimal. The aim of this process evaluation was to study these aspects alongside a randomized controlled trial investigating the effects of a multidisciplinary biannual medication review in long-term care organizations (NTR3569).
DESIGN


Process evaluation with multiple measurements.
SETTING


Thirteen units for people with dementia in six long-term care organizations in the Netherlands.
PARTICIPANTS


Physicians, pharmacists, and nursing staff of participating units.
INTERVENTION


The PROPER intervention is a structured and biannually repeated multidisciplinary medication review supported by organizational preparation and education, evaluation, and guidance.
MEASUREMENTS


Web-based questionnaires, interviews, attendance lists of education sessions, medication reviews and evaluation meetings, minutes, evaluation, and registration forms.
RESULTS


Participation rates in education sessions (95%), medication reviews (95%), and evaluation meetings (82%) were high. The intervention's relevance and feasibility and applied implementation strategies were highly rated. However, the education sessions and conversations during medication reviews were too pharmacologically oriented for several nursing staff members. Identified barriers to implementation were required time, investment, planning issues, and high staff turnover; facilitators were the positive attitude of professionals toward the intervention, the support of higher management, and the appointment of a local implementation coordinator.
CONCLUSION


Implementation was successful. The commitment of both higher management and professionals was an important factor. This may partly have been due to the subject being topical; Dutch long-term-care organizations are pressed to lower inappropriate psychotropic drug use.",2021,"RESULTS


Participation rates in education sessions (95%), medication reviews (95%), and evaluation meetings (82%) were high.","['Thirteen units for people with dementia in six long-term care organizations in the Netherlands', 'Physicians, pharmacists, and nursing staff of participating units', 'nursing home residents with dementia']",[],"['Web-based questionnaires, interviews, attendance lists of education sessions, medication reviews and evaluation meetings, minutes, evaluation, and registration forms']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0023977'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staff'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]",[],"[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",,0.0394132,"RESULTS


Participation rates in education sessions (95%), medication reviews (95%), and evaluation meetings (82%) were high.","[{'ForeName': 'Debby L', 'Initials': 'DL', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'de Vries', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Smalbrugge', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Claudia H W', 'Initials': 'CHW', 'LastName': 'Smeets', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Klaas', 'Initials': 'K', 'LastName': 'van der Spek', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Sytse U', 'Initials': 'SU', 'LastName': 'Zuidema', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Raymond T C M', 'Initials': 'RTCM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",International psychogeriatrics,['10.1017/S1041610219000577']
103,18538648,"Low-intensity pulsed ultrasound increases bone volume, osteoid thickness and mineral apposition rate in the area of fracture healing in patients with a delayed union of the osteotomized fibula.","INTRODUCTION


Low-intensity pulsed ultrasound (LIPUS) accelerates impaired fracture healing, but the exact mechanism is unknown. The aim of this study was to investigate how LIPUS affects bone healing at the tissue level in patients with a delayed union of the osteotomized fibula, by using histology and histomorphometric analysis to determine bone formation and bone resorption parameters.
MATERIALS AND METHODS


Biopsies were obtained from 13 patients (9 female, 4 male; age 42-63) with a delayed union of the osteotomized fibula after a high tibial osteotomy, treated for 2-4 months with or without LIPUS in a randomized prospective double-blind placebo-controlled trial. In the histological sections of the delayed union biopsies, 3 areas of interest were distinguished, i.e. 1) area of new bone formation at the fracture ends, 2) area of cancellous bone, and 3) area of cortical bone. Histomorphometrical analysis was performed to determine bone formation and bone resorption parameters (as well as angiogenesis).
RESULTS


In LIPUS-treated delayed unions, endosteal callus formation by direct bone formation without a cartilage intermediate as well as indirect bone formation was observed, while in untreated controls only indirect bone formation was observed. In the area of new bone formation, LIPUS significantly increased osteoid thickness by 47%, mineral apposition rate by 27%, and bone volume by 33%. No increase in the number of blood vessels was seen in the newly formed bony callus. In the area of cancellous bone, bone volume was significantly increased by 17% whereas no effect on osteoid thickness and mineral apposition rate was seen. LIPUS did not affect osteoid volume, osteoid maturation time, number of osteocytes, osteocyte lacunae, or osteoclast-like cells in any of the areas of interest.
CONCLUSIONS


Our results suggest that LIPUS accelerates clinical fracture healing of delayed unions of the fibula by increasing osteoid thickness, mineral apposition rate, and bone volume, indicating increased osteoblast activity, at the front of new bony callus formation. Improved stability and/or increased blood flow, but probably not increased angiogenesis, might explain the differences in ossification modes between LIPUS-treated delayed unions and untreated controls.",2008,"In the area of new bone formation, LIPUS significantly increased osteoid thickness by 47%, mineral apposition rate by 27%, and bone volume by 33%.","['patients with a delayed union of the osteotomized fibula', 'Biopsies were obtained from 13 patients (9 female, 4 male; age 42-63) with a delayed union of the osteotomized fibula after a high tibial osteotomy, treated for 2-4 months with or without', 'patients with a delayed union of the osteotomized fibula, by using histology and histomorphometric analysis to determine bone formation and bone resorption parameters']","['Low-intensity pulsed ultrasound (LIPUS', 'placebo', 'LIPUS']","['bone volume, osteoid thickness and mineral apposition rate', 'Improved stability and/or increased blood flow', 'mineral apposition rate', 'indirect bone formation', 'bone volume', 'osteoid thickness and mineral apposition rate', 'bone healing', 'osteoid thickness, mineral apposition rate, and bone volume', 'osteoid volume, osteoid maturation time, number of osteocytes, osteocyte lacunae, or osteoclast-like cells', 'osteoid thickness', 'number of blood vessels', 'bone formation and bone resorption parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016068', 'cui_str': 'Fibula'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia (procedure)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C4042796', 'cui_str': 'Low Intensity Pulsed Ultrasound'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0232341', 'cui_str': 'Increased vascular flow (finding)'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029432', 'cui_str': 'Osteocytes'}, {'cui': 'C0029431', 'cui_str': 'Osteoclasts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0005847', 'cui_str': 'Blood Vessel'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",63.0,0.0297836,"In the area of new bone formation, LIPUS significantly increased osteoid thickness by 47%, mineral apposition rate by 27%, and bone volume by 33%.","[{'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Rutten', 'Affiliation': 'Department of Oral Cell Biology, ACTA-Universiteit van Amsterdam and Vrije Universiteit, Research Institute MOVE, Amsterdam, The Netherlands; Department of Orthopaedic Surgery, Spaarne Hospital, Hoofddorp, The Netherlands.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Nolte', 'Affiliation': 'Department of Orthopaedic Surgery, Spaarne Hospital, Hoofddorp, The Netherlands.'}, {'ForeName': 'Clara M', 'Initials': 'CM', 'LastName': 'Korstjens', 'Affiliation': 'Department of Oral Cell Biology, ACTA-Universiteit van Amsterdam and Vrije Universiteit, Research Institute MOVE, Amsterdam, The Netherlands.'}, {'ForeName': 'Marion A', 'Initials': 'MA', 'LastName': 'van Duin', 'Affiliation': 'Department of Oral Cell Biology, ACTA-Universiteit van Amsterdam and Vrije Universiteit, Research Institute MOVE, Amsterdam, The Netherlands.'}, {'ForeName': 'Jenneke', 'Initials': 'J', 'LastName': 'Klein-Nulend', 'Affiliation': 'Department of Oral Cell Biology, ACTA-Universiteit van Amsterdam and Vrije Universiteit, Research Institute MOVE, Amsterdam, The Netherlands. Electronic address: j.kleinnulend@vumc.nl.'}]",Bone,['10.1016/j.bone.2008.04.010']
104,18519174,"Effect of risedronate on hip structural geometry: a 1-year, double-blind trial in chemotherapy-induced postmenopausal women.","INTRODUCTION


Chemotherapy-induced menopause is associated with bone loss. The effect on structural geometry is unknown. Our objective was to determine if oral bisphosphonate therapy could maintain or improve femoral geometry in breast cancer patients with chemotherapy-induced menopause.
METHODS


This preplanned 1 year interim, secondary analysis of the Risedronate's Effect on Bone loss in Breast CAncer Study (REBBeCA Study) examined hip structure analysis (HSA), i.e. changes in the bone cross-sectional area (bone CSA), section modulus (SM: measure of bending strength), cortical thickness (CT) and buckling ratio (BR: index of cortical bone stability), in a double-blind trial of 87 newly postmenopausal, nonmetastatic breast cancer patients, randomized to risedronate, 35 mg once weekly (RIS) versus placebo (PBO).
RESULTS


After 12 months, intertrochanteric parameters demonstrated percentage improvement (RIS vs. PBO) from baseline in bone CSA (mean+/-SD: 4.25+/-6.29 vs. 0.60+/-5.99%), SM (3.97+/-6.40 vs. 0.80+/-7.08%), and CT [5.20+/-6.98 vs. 1.13+/-6.87% (all p-values <0.05 except SM p=0,0643)]. Similar improvements were observed at the femoral shaft [bone CSA: 2.24+/-5.74 vs. -0.78+/-5.73%; SM: 1.62+/-6.23 vs. -1.39+/-7.06%; CT: 3.79+/-7.84 vs. -0.17+/-7.90% (all p-values <0.05, RIS vs. PBO, except SM p= p =0.0568)]. At both sites, the BR had significant decreases consistent with improved strength.
CONCLUSION


We conclude that RIS improves measures of hip structural geometry in women with breast cancer following chemotherapy.",2008,"Similar improvements were observed at the femoral shaft [bone CSA: 2.24+/-5.74 vs. -0.78+/-5.73%; SM: 1.62+/-6.23 vs. -1.39+/-7.06%; CT: 3.79+/-7.84 vs. -0.17+/-7.90% (all p-values <0.05, RIS vs. PBO, except SM p= p =0.0568)].","['87 newly postmenopausal, nonmetastatic breast cancer patients', 'breast cancer patients with chemotherapy-induced menopause', 'women with breast cancer following chemotherapy', 'chemotherapy-induced postmenopausal women']","['risedronate', 'CT', 'risedronate, 35 mg once weekly (RIS) versus placebo (PBO', 'RIS', 'bone CSA', 'bisphosphonate therapy']","['hip structural geometry', 'femoral geometry', 'femoral shaft [bone CSA', 'bone cross-sectional area (bone CSA), section modulus (SM: measure of bending strength), cortical thickness (CT) and buckling ratio (BR: index of cortical bone stability', 'Bone loss', 'strength']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C4510264', 'cui_str': 'Disphosphonate therapy'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0449829', 'cui_str': 'Geometry (attribute)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4704755', 'cui_str': 'Flexural Properties'}, {'cui': 'C0542562', 'cui_str': 'Buckle (physical object)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone (body structure)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",87.0,0.390017,"Similar improvements were observed at the femoral shaft [bone CSA: 2.24+/-5.74 vs. -0.78+/-5.73%; SM: 1.62+/-6.23 vs. -1.39+/-7.06%; CT: 3.79+/-7.84 vs. -0.17+/-7.90% (all p-values <0.05, RIS vs. PBO, except SM p= p =0.0568)].","[{'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'van Londen', 'Affiliation': 'Medicine, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: vanLondenJ@upmc.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Medicine and Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Vujevich', 'Affiliation': 'Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'Biostatistics, Health and Community Systems, and Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bhattacharya', 'Affiliation': 'Medicine, University of Kansas, Kansas City, KS, USA.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': 'Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Bone,['10.1016/j.bone.2008.03.027']
105,18468827,Targeting oxidative stress in surgery: effects of ageing and therapy.,"In the current era cardiac surgeons are being called upon to operate upon older, sicker patients. The effect is to augment oxidative stress and increase the rate of post-operative complications and ultimately mortality. We have developed antioxidant-based pre-treatment regimes initially based on coenzyme Q(10). A randomised trial of coenzyme Q(10) in elective cardiac surgery patients demonstrated augmented plasma and cardiac mitochondrial membrane coenzyme Q(10) content, improved mitochondrial respiration and increased myocardial tolerance of oxidative stress. The addition of omega-3 polyunsaturated fatty acids, alpha-lipoic acid, selenium and magnesium orotate in a second clinical trial, improved post-operative recovery with demonstrable reductions in myocardial damage, rate of atrial fibrillation and length of hospital stay. Finally we performed a pilot study of this combined metabolic therapy regimen to which we added preoperative physical exercise and mental stress reduction with indications of further improvements in post-operative recovery. We conclude that simultaneously targeting a number of key deficiencies with a metabolic formulation prior to surgery results in peri- and post-operative clinical and economic benefits.",2008,"A randomised trial of coenzyme Q(10) in elective cardiac surgery patients demonstrated augmented plasma and cardiac mitochondrial membrane coenzyme Q(10) content, improved mitochondrial respiration and increased myocardial tolerance of oxidative stress.",['elective cardiac surgery patients'],"['coenzyme Q(10', 'omega-3 polyunsaturated fatty acids, alpha-lipoic acid, selenium and magnesium orotate']","['myocardial damage, rate of atrial fibrillation and length of hospital stay', 'oxidative stress', 'plasma and cardiac mitochondrial membrane coenzyme Q(10) content, improved mitochondrial respiration and increased myocardial tolerance of oxidative stress', 'rate of post-operative complications and ultimately mortality']","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009235', 'cui_str': 'Cofactors, Enzyme'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0023791', 'cui_str': 'alpha-lipoic acid'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0536004', 'cui_str': 'magnesium orotate'}]","[{'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0596952', 'cui_str': 'Mitochondrial Membranes'}, {'cui': 'C2242675', 'cui_str': 'Coenzyme Q'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.17845,"A randomised trial of coenzyme Q(10) in elective cardiac surgery patients demonstrated augmented plasma and cardiac mitochondrial membrane coenzyme Q(10) content, improved mitochondrial respiration and increased myocardial tolerance of oxidative stress.","[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pepe', 'Affiliation': 'CJOB Department of Cardiothoracic Surgery, Alfred Hospital, PO Box 315 Prahran, Melbourne VIC 318, Australia; Department of Surgery, Monash University, Melbourne, Australia; Baker Heart Research Institute, Melbourne, Australia Melbourne, Australia.'}, {'ForeName': 'Jee-Yoong', 'Initials': 'JY', 'LastName': 'Leong', 'Affiliation': 'CJOB Department of Cardiothoracic Surgery, Alfred Hospital, PO Box 315 Prahran, Melbourne VIC 318, Australia; Department of Surgery, Monash University, Melbourne, Australia.'}, {'ForeName': 'Juliana Van der', 'Initials': 'JV', 'LastName': 'Merwe', 'Affiliation': 'CJOB Department of Cardiothoracic Surgery, Alfred Hospital, PO Box 315 Prahran, Melbourne VIC 318, Australia; Department of Surgery, Monash University, Melbourne, Australia.'}, {'ForeName': 'Silvana F', 'Initials': 'SF', 'LastName': 'Marasco', 'Affiliation': 'CJOB Department of Cardiothoracic Surgery, Alfred Hospital, PO Box 315 Prahran, Melbourne VIC 318, Australia; Department of Surgery, Monash University, Melbourne, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Hadj', 'Affiliation': 'CJOB Department of Cardiothoracic Surgery, Alfred Hospital, PO Box 315 Prahran, Melbourne VIC 318, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Lymbury', 'Affiliation': 'Griffith University, Qld., Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Perkins', 'Affiliation': 'Griffith University, Qld., Australia.'}, {'ForeName': 'Franklin L', 'Initials': 'FL', 'LastName': 'Rosenfeldt', 'Affiliation': 'CJOB Department of Cardiothoracic Surgery, Alfred Hospital, PO Box 315 Prahran, Melbourne VIC 318, Australia; Department of Surgery, Monash University, Melbourne, Australia; Baker Heart Research Institute, Melbourne, Australia Melbourne, Australia.'}]",Experimental gerontology,['10.1016/j.exger.2008.03.011']
106,18620949,"Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial.","BACKGROUND


Any benefit of adjuvant interferon alfa-2b for melanoma could depend on dose and duration of treatment. Our aim was to determine whether pegylated interferon alfa-2b can facilitate prolonged exposure while maintaining tolerability.
METHODS


1256 patients with resected stage III melanoma were randomly assigned to observation (n=629) or pegylated interferon alfa-2b (n=627) 6 mug/kg per week for 8 weeks (induction) then 3 mug/kg per week (maintenance) for an intended duration of 5 years. Randomisation was stratified for microscopic (N1) versus macroscopic (N2) nodal involvement, number of positive nodes, ulceration and tumour thickness, sex, and centre. Randomisation was done with a minimisation technique. The primary endpoint was recurrence-free survival. Analyses were done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00006249.
FINDINGS


All randomised patients were included in the primary efficacy analysis. 608 patients in the interferon group and 613 patients in the observation group were included in safety analyses. The median length of treatment with pegylated interferon alfa-2b was 12 (IQR 3.8-33.4) months. At 3.8 (3.2-4.2) years median follow-up, 328 recurrence events had occurred in the interferon group compared with 368 in the observation group (hazard ratio 0.82, 95% CI 0.71-0.96; p=0.01); the 4-year rate of recurrence-free survival was 45.6% (SE 2.2) in the interferon group and 38.9% (2.2) in the observation group. There was no difference in overall survival between the groups. Grade 3 adverse events occurred in 246 (40%) patients in the interferon group and 60 (10%) in the observation group; grade 4 adverse events occurred in 32 (5%) patients in the interferon group and 14 (2%) in the observation group. In the interferon group, the most common grade 3 or 4 adverse events were fatigue (97 patients, 16%), hepatotoxicity (66, 11%), and depression (39, 6%). Treatment with pegylated interferon alfa-2b was discontinued because of toxicity in 191 (31%) patients.
INTERPRETATION


Adjuvant pegylated interferon alfa-2b for stage III melanoma has a significant, sustained effect on recurrence-free survival.",2008,"In the interferon group, the most common grade 3 or 4 adverse events were fatigue (97 patients, 16%), hepatotoxicity (66, 11%), and depression (39, 6%).","['resected stage III melanoma', '608 patients in the interferon group and 613 patients in the observation group', '1256 patients with resected stage III melanoma']","['pegylated interferon alfa-2b', 'pegylated interferon alfa-2b versus observation alone']","['hepatotoxicity', 'toxicity', 'Grade 3 adverse events', 'overall survival', 'median length', 'recurrence-free survival', '4-year rate of recurrence-free survival', 'grade 4 adverse events']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1256.0,0.583901,"In the interferon group, the most common grade 3 or 4 adverse events were fatigue (97 patients, 16%), hepatotoxicity (66, 11%), and depression (39, 6%).","[{'ForeName': 'Alexander Mm', 'Initials': 'AM', 'LastName': 'Eggermont', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, Netherlands. Electronic address: a.m.m.eggermont@erasmusmc.nl.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Santinami', 'Affiliation': 'Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Testori', 'Affiliation': 'Istituto Europeo di Oncologia, Milan, Italy.'}, {'ForeName': 'Wim Hj', 'Initials': 'WH', 'LastName': 'Kruit', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'University Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Cornelis Ja', 'Initials': 'CJ', 'LastName': 'Punt', 'Affiliation': 'University Medical Center St Radboud, Nijmegen, Netherlands.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Salès', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gore', 'Affiliation': 'Royal Marsden Hospital NHS, London, UK.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'MacKie', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Zvonko', 'Initials': 'Z', 'LastName': 'Kusic', 'Affiliation': 'University Hospital Sestre Milosrdnice, Zagreb, Croatia.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University Clinic Zürich, Zürich, Switzerland.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'University Hospital Kiel, Kiel, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Musat', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Spatz', 'Affiliation': 'Institut Gustave-Roussy, Villejuif, France.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Charité, Benjamin Franklin Campus, Berlin, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(08)61033-8']
107,18602688,"An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial.","BACKGROUND


Treatment of localised renal cell carcinoma consists of partial or radical nephrectomy. A substantial proportion of patients are at risk for recurrence because no effective adjuvant therapy exists. We investigated the use of an autologous, tumour-derived heat-shock protein (glycoprotein 96)-peptide complex (HSPPC-96; vitespen) as adjuvant treatment in patients at high risk of recurrence after resection of locally advanced renal cell carcinoma.
METHODS


In this open-label trial, patients were randomly assigned to receive either vitespen (n=409) or observation alone (n=409) after nephrectomy. Randomisation was done in a one to one ratio by a computer-generated pseudo-random number generator, with a block size of four, and was stratified by performance score, lymph node status, and nuclear grade. Vitespen was given intradermally once a week for 4 weeks, then every 2 weeks until vaccine depletion. The primary endpoint was recurrence-free survival. The final analysis of recurrence-free survival was planned to take place after 214 or more events of disease recurrence or deaths before recurrence had occurred. Analysis was by intention to treat (ITT). This study is registered with ClinicalTrials.gov, number NCT00033904.
FINDINGS


48 patients in the vitespen group and 42 in the observation group were excluded from the ITT population because they did not meet post-surgery inclusion criteria; the ITT population thus consisted of 361 patients in the vitespen group and 367 in the observation group. Final analysis of recurrence-free survival was triggered in November, 2005. Re-review of all patients in the ITT population by the clinical events committee identified 149 actual recurrences (73 in the vitespen group and 76 in the observation group), nine deaths before recurrence (two in the vitespen group and seven in the observation group), and 124 patients with baseline metastatic or residual disease (61 in the vitespen group and 63 in the observation group). Thus, after a median follow-up of 1.9 years (IQR 0.9-2.5) in the ITT population, recurrence events were reported in 136 (37.7%) patients in the vitespen group and 146 (39.8%) in the observation group (hazard ratio 0.923, 95% CI 0.729-1.169; p=0.506). After continued follow-up until March, 2007, there had been 70 deaths in the vitespen group and 72 in the observation group (p=0.896); however, overall survival data were not mature, and patients continue to be followed up for survival. In predefined exploratory analyses by AJCC stage, recurrence events in patients with stage I or II disease were reported in 19 (15.2%) patients in the vitespen group and 31 (27.0%) in the observation group (hazard ratio 0.576, 95% CI 0.324-1.023; p=0.056). The most commonly reported adverse events in the vitespen group were injection-site erythema (n=158) and injection-site induration (n=153). One serious adverse event-autoimmune thyroiditis of grade 2 severity-was reported in the vitespen group; no treatment-related grade 3 or 4 adverse events were reported.
INTERPRETATION


No difference in recurrence-free survival was seen between patients given vitespen and those who received no treatment after nephrectomy for renal cell carcinoma. A possible improvement in recurrence-free survival in patients with early stage disease who received vitespen will require further validation.",2008,No difference in recurrence-free survival was seen between patients given vitespen and those who received no treatment after nephrectomy for renal cell carcinoma.,"['48 patients in the vitespen group and 42 in the observation group were excluded from the ITT population because they did not meet post-surgery inclusion criteria; the ITT population thus consisted of 361 patients in the vitespen group and 367 in the observation group', 'patients with early stage disease', 'patients at high risk of recurrence after nephrectomy for renal cell carcinoma', 'patients at high risk of recurrence after resection of locally advanced renal cell carcinoma', '124 patients with baseline metastatic or residual disease (61 in the vitespen group and 63 in the observation group']","['autologous, tumour-derived heat-shock protein (glycoprotein 96)-peptide complex (HSPPC-96; vitespen', 'vitespen (n=409) or observation alone (n=409) after nephrectomy', 'radical nephrectomy', 'adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen']","['nine deaths before recurrence', 'recurrence events', 'overall survival data', 'recurrence-free survival', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0018850', 'cui_str': 'Stress Proteins'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C0401181', 'cui_str': 'Radical nephrectomy (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.253031,No difference in recurrence-free survival was seen between patients given vitespen and those who received no treatment after nephrectomy for renal cell carcinoma.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wood', 'Affiliation': 'M D Anderson Cancer Center, Houston, TX, USA. Electronic address: cgwood@mdanderson.org.'}, {'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Srivastava', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Bukowski', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Lacombe', 'Affiliation': ""CHUQ-Hôtel-Dieu de Québec, Pavillon de Recherche de L'Hôpital I'Hôtel Dieu, Quebec City, Quebec, Canada.""}, {'ForeName': 'Andrei I', 'Initials': 'AI', 'LastName': 'Gorelov', 'Affiliation': 'St Petersburg State University, St Petersburg, Russia.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Gorelov', 'Affiliation': 'St Petersburg Hospital 122, St Petersburg, Russia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mulders', 'Affiliation': 'UMC St Radboud, Nijmegen, Netherlands.'}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Zielinski', 'Affiliation': 'Centralny Szpital Kliniczny WAM, Warsaw, Poland.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hoos', 'Affiliation': 'Bristol-Myers Squibb, New York, NY, USA.'}, {'ForeName': 'Florentina', 'Initials': 'F', 'LastName': 'Teofilovici', 'Affiliation': 'Antigenics, New York, NY, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Isakov', 'Affiliation': 'Antigenics, New York, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Flanigan', 'Affiliation': 'Loyola University Medical Center, Maywood, IL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Figlin', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Transave Inc, Monmouth, NJ, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(08)60697-2']
108,32204742,Treatment selection in borderline personality disorder between dialectical behavior therapy and psychodynamic psychiatric management.,"BACKGROUND


No evidence-based therapy for borderline personality disorder (BPD) exhibits a clear superiority. However, BPD is highly heterogeneous, and different patients may specifically benefit from the interventions of a particular treatment.
METHODS


From a randomized trial comparing a year of dialectical behavior therapy (DBT) to general psychiatric management (GPM) for BPD, long-term (2-year-post) outcome data and patient baseline variables (n = 156) were used to examine individual and combined patient-level moderators of differential treatment response. A two-step bootstrapped and partially cross-validated moderator identification process was employed for 20 baseline variables. For identified moderators, 10-fold bootstrapped cross-validated models estimated response to each therapy, and long-term outcomes were compared for patients randomized to their model-predicted optimal v. non-optimal treatment.
RESULTS


Significant moderators surviving the two-step process included psychiatric symptom severity, BPD impulsivity symptoms (both GPM > DBT), dependent personality traits, childhood emotional abuse, and social adjustment (all DBT > GPM). Patients randomized to their model-predicted optimal treatment had significantly better long-term outcomes (d = 0.36, p = 0.028), especially if the model had a relatively stronger (top 60%) prediction for that patient (d = 0.61, p = 0.004). Among patients with a stronger prediction, this advantage held even when applying a conservative statistical check (d = 0.46, p = 0.043).
CONCLUSIONS


Patient characteristics influence the degree to which they respond to two treatments for BPD. Combining information from multiple moderators may help inform providers and patients as to which treatment is the most likely to lead to long-term symptom relief. Further research on personalized medicine in BPD is needed.",2021,"Patients randomized to their model-predicted optimal treatment had significantly better long-term outcomes (d = 0.36, p = 0.028), especially if the model had a relatively stronger (top 60%) prediction for that patient (d = 0.61, p = 0.004).",['borderline personality disorder (BPD'],"['dialectical behavior therapy (DBT', 'dialectical behavior therapy and psychodynamic psychiatric management']","['psychiatric symptom severity, BPD impulsivity symptoms (both GPM > DBT), dependent personality traits, childhood emotional abuse, and social adjustment (all DBT > GPM', 'better long-term outcomes']","[{'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}]","[{'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233868', 'cui_str': 'Passive character (finding)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0730557', 'cui_str': 'Emotional abuse (event)'}, {'cui': 'C0037395', 'cui_str': 'Social Adjustment'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",156.0,0.0391429,"Patients randomized to their model-predicted optimal treatment had significantly better long-term outcomes (d = 0.36, p = 0.028), especially if the model had a relatively stronger (top 60%) prediction for that patient (d = 0.61, p = 0.004).","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry, Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Thomas T', 'Initials': 'TT', 'LastName': 'Kim', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'DeRubeis', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': 'Department of Psychiatry & Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Links', 'Affiliation': 'Department of Psychiatry & Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Shelley F', 'Initials': 'SF', 'LastName': 'McMain', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}]",Psychological medicine,['10.1017/S0033291720000550']
109,29522897,Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial.,"BACKGROUND


Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care.
METHODS/DESIGN


This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems.
DISCUSSION


This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592.",2018,Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning.,"['patients with chronic pain on long-term', 'primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an']","['interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT', 'opioid treatment in primary care (PPACT) - Protocol', 'interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services']","['pain-related disability, patient satisfaction, opioids dispensed and health care utilization', 'pain impact', 'pain impact (a composite of pain intensity and pain-related interference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.139124,Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning.,"[{'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'DeBar', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States. Electronic address: debar.l@ghc.org.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Benes', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States; University of Portland, School of Nursing, Portland, OR, United States.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Bonifay', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Deyo', 'Affiliation': 'Oregon Health and Science University, School of Medicine, Portland, OR, United States.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Elder', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Duke University, School of Medicine, Durham, NC, United States.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States.'}, {'ForeName': 'Carmit', 'Initials': 'C', 'LastName': 'McMullen', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Mayhew', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States.'}, {'ForeName': 'Ashli', 'Initials': 'A', 'LastName': 'Owen-Smith', 'Affiliation': 'Georgia State University, School of Public Health, Atlanta, GA, United States; Kaiser Permanente Center for Clinical and Outcomes Research, Atlanta, GA, United States.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Smith', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States.'}, {'ForeName': 'Connie M', 'Initials': 'CM', 'LastName': 'Trinacty', 'Affiliation': 'Kaiser Permanente Center for Health Research, Honolulu, HI, United States.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Vollmer', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.02.015']
110,18539106,"Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial.","INTRODUCTION


Denosumab is a fully human monoclonal antibody that inhibits receptor activator of nuclear factor-kappa B ligand (RANKL), an essential mediator of osteoclast formation, function, and survival that has been shown to decrease bone turnover and increase bone mineral density (BMD) in treated patients. We assessed the long-term efficacy and safety of denosumab, and the effects of discontinuing and restarting denosumab treatment in postmenopausal women with low bone mass.
METHODS


Postmenopausal women with a lumbar spine T-score of -1.8 to -4.0 or proximal femur T-score of -1.8 to -3.5 were randomized to denosumab every 3 months (Q3M; 6, 14, or 30 mg) or every 6 months (Q6M; 14, 60, 100, or 210 mg); placebo; or open-label oral alendronate weekly. After 24 months, patients receiving denosumab either continued treatment at 60 mg Q6M for an additional 24 months, discontinued therapy, or discontinued treatment for 12 months then re-initiated denosumab (60 mg Q6M) for 12 months. The placebo cohort was maintained. Alendronate-treated patients discontinued alendronate and were followed. Changes in BMD and bone turnover markers (BTM) as well as safety outcomes were evaluated.
RESULTS


Overall, 262/412 (64%) patients completed 48 months of study. Continuous, long-term denosumab treatment increased BMD at the lumbar spine (9.4% to 11.8%) and total hip (4.0% to 6.1%). BTM were consistently suppressed over 48 months. Discontinuation of denosumab was associated with a BMD decrease of 6.6% at the lumbar spine and 5.3% at the total hip within the first 12 months of treatment discontinuation. Retreatment with denosumab increased lumbar spine BMD by 9.0% from original baseline values. Levels of BTM increased upon discontinuation and decreased with retreatment. Adverse event rates were similar among treatment groups.
CONCLUSIONS


In postmenopausal women with low BMD, long-term denosumab treatment led to gains in BMD and reduction of BTM throughout the course of the study. The effects on bone turnover were fully reversible with discontinuation and restored with subsequent retreatment.",2008,"In postmenopausal women with low BMD, long-term denosumab treatment led to gains in BMD and reduction of BTM throughout the course of the study.","['postmenopausal women with low bone mass', 'postmenopausal women with low BMD', 'Postmenopausal women with a lumbar spine T-score of -1.8 to -4.0 or proximal femur T-score of -1.8 to -3.5 were randomized to', 'postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy']","['placebo', 'denosumab', 'discontinuing and restarting denosumab treatment', 'placebo; or open-label oral alendronate weekly', 'Alendronate-treated patients discontinued alendronate']","['total hip', 'BTM', 'lumbar spine BMD', 'bone turnover', 'BMD and bone turnover markers (BTM', 'BMD decrease', 'bone density and turnover', 'bone mineral density (BMD', 'BMD and reduction of BTM', 'Levels of BTM', 'BMD at the lumbar spine', 'Adverse event rates']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0706536,"In postmenopausal women with low BMD, long-term denosumab treatment led to gains in BMD and reduction of BTM throughout the course of the study.","[{'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Miller', 'Affiliation': 'Colorado Center for Bone Research, 3190 South Wadsworth Blvd, Ste 250, Lakewood, CO 80227, USA. Electronic address: millerccbr@aol.com.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bolognese', 'Affiliation': 'Bethesda Health Research Center, Bethesda, MD, USA.'}, {'ForeName': 'E Michael', 'Initials': 'EM', 'LastName': 'Lewiecki', 'Affiliation': 'New Mexico Clinical Research and Osteoporosis Center, Albuquerque, NM, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, Portland, OR, USA.'}, {'ForeName': 'Beiying', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Austin', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'San Martin', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Bone,['10.1016/j.bone.2008.04.007']
111,18325725,Phenotype and function of dendritic cells and T-lymphocyte polarization in the human colonic mucosa and adenocarcinoma.,"AIM


To evaluate the status of activation of the intestinal dendritic cells (DCs) and T lymphocytes (T cells) from surgical specimens of human colon and adenocarcinoma, and the potential effect of administration of interleukin 2 (IL-2).
METHODS


Patients undergoing colectomy for cancer were randomized to receive subcutaneous IL-2 (12million UI/day) (treated group; n=10) for 3days before operation or no treatment (control group, n=10). DCs and T cells were isolated and purified from the lamina propria (LP) of segments of normal colon and adenocarcinoma of both groups. Cell phenotype was determined by expression of membrane receptors. Interaction between DC and T cells was assesses by a mixed leukocyte reaction using naïve T cells co-cultured with DCs. CD4+ T-cell polarization was studied by intracellular staining with monoclonal antibodies for interleukin-4 and interferon-gamma.
RESULTS


CD4+ T cells were significantly less in tumour than in LP (p<0.05) in both treated and control groups. IL-2 did not modify the number of any of the T-cell subsets analysed. In contrast, T cells isolated from LP and neoplasm of treated patients produced more interferon-gamma and less interleukin-4 (p<0.05 vs. controls). IL-2 administration significantly increased (p<0.05) the number of mature, myeloid and plasmocytoid DCs compared to controls. Allogeneic naïve T cells were polarized toward a Th1 type of response which appeared to be mediated by IL-2 activated DCs.
CONCLUSIONS


systemic IL-2 treatment may have immunomodulatory properties on intestinal DC maturation and drive a Th1 mediated anti-neoplastic response.",2008,"administration significantly increased (p<0.05) the number of mature, myeloid and plasmocytoid DCs compared to controls.","['surgical specimens of human colon and adenocarcinoma', 'human colonic mucosa and adenocarcinoma', 'Patients undergoing colectomy for cancer']","['IL-2', 'subcutaneous IL-2 (12million UI/day) (treated group; n=10) for 3days before operation or no treatment (control']","['intestinal dendritic cells (DCs) and T lymphocytes (T cells', 'CD4+ T cells', 'DCs and T cells', 'Allogeneic naïve T cells', 'number of mature, myeloid and plasmocytoid DCs']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009274', 'cui_str': 'Large Bowel Resection'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0439677', 'cui_str': 'Myeloid (qualifier value)'}]",,0.079203,"administration significantly increased (p<0.05) the number of mature, myeloid and plasmocytoid DCs compared to controls.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gianotti', 'Affiliation': 'Department of Surgery, University of Milano-Bicocca, San Gerardo Hospital (5(o) piano A), Via Pergolesi 33, 20052 Monza, Italy. Electronic address: luca.gianotti@unimib.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sargenti', 'Affiliation': 'Department of Surgery, University of Milano-Bicocca, San Gerardo Hospital (5(o) piano A), Via Pergolesi 33, 20052 Monza, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Galbiati', 'Affiliation': 'Department of Surgery, University of Milano-Bicocca, San Gerardo Hospital (5(o) piano A), Via Pergolesi 33, 20052 Monza, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Nespoli', 'Affiliation': 'Department of Surgery, University of Milano-Bicocca, San Gerardo Hospital (5(o) piano A), Via Pergolesi 33, 20052 Monza, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Brivio', 'Affiliation': 'Department of Surgery, University of Milano-Bicocca, San Gerardo Hospital (5(o) piano A), Via Pergolesi 33, 20052 Monza, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rescigno', 'Affiliation': 'Department of Experimental Oncology, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nespoli', 'Affiliation': 'Department of Surgery, University of Milano-Bicocca, San Gerardo Hospital (5(o) piano A), Via Pergolesi 33, 20052 Monza, Italy.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2008.01.026']
112,18164104,Nursing students' learning of managing cross-infections--scenario-based simulation training versus study groups.,"Up to 33% of all health care-associated infections are preventable [Alexander, M., 2006. Nursing Practice. Hospital and Home. Elsevier, Churchill Livingstone]. Nurses must consider how they can address infection prevention, control and management within health care settings. An outbreak of any infectious disease can occasionally occur, even when protocols have been followed. A well-coordinated, multidiscipline response will minimize the impact of the outbreak by controlling and managing the impact and ongoing risks. In this study nursing students were challenged to manage cross-infections based on two hypothetical cases, MRSA and Norovirus. The purpose of the study was to determine the most efficient teaching strategies for managing cross-infections and determining the teachers' role by comparing three different teaching methods; scenario-based study groups with and without teacher and simulation training. A class of 141 2nd year nursing students participated as part of their learning programme on infection control. Out of these 21 students were randomly selected to take part in three focus groups assigned to evaluate the program. Overall, the findings indicated that scenario-based simulation training made the students more aware of how complex each scenario was. Events occurred that they had not expected, and this lead to a better recollection of details. By asking appropriate questions, giving feedback and hypothetical examples, the teacher's role was crucial in both teaching strategies.",2008,"Overall, the findings indicated that scenario-based simulation training made the students more aware of how complex each scenario was.","['21 students', 'A class of 141 2nd year nursing students participated as part of their learning programme on infection control']",[],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0085557', 'cui_str': 'Infection Control'}]",[],[],,0.0131482,"Overall, the findings indicated that scenario-based simulation training made the students more aware of how complex each scenario was.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Mikkelsen', 'Affiliation': 'Center for Shared Decision Making and Nursing Research, Rikshospitalet Medical Center, N-0027 Oslo, Norway.'}, {'ForeName': 'Marit Hegg', 'Initials': 'MH', 'LastName': 'Reime', 'Affiliation': 'Institute of Nursing, Bergen University College, Norway.'}, {'ForeName': 'Anette K', 'Initials': 'AK', 'LastName': 'Harris', 'Affiliation': 'Department of Health Education and Health Promotion, University of Bergen, Norway.'}]",Nurse education today,['10.1016/j.nedt.2007.11.003']
113,18544475,Clinical evaluation of medicinal products for acceleration of fracture healing in patients with osteoporosis.,"Pre-clinical studies indicate that pharmacologic agents can augment fracture union. If these pharmacologic approaches could be translated into clinical benefit and offered to patients with osteoporosis or patients with other risks for impaired fracture union (e.g. in subjects with large defects or open fractures with high complication rate), they could provide an important adjunct to the treatment of fractures. However, widely accepted guidelines are important to encourage the conduct of studies to evaluate bioactive substances, drugs, and new agents that may promote fracture union and subsequent return to normal function. A consensus process was initiated to provide recommendations for the clinical evaluation of potential therapies to augment fracture repair in patients with meta- and diaphyseal fractures. Based on the characteristics of fracture healing and fixation, the following study objectives of a clinical study may be appropriate: a) acceleration of fracture union, b) acceleration of return to normal function and c) reduction of fracture healing complications. The intended goal(s) should determine subsequent study methodology. While an acceleration of return to normal function or a reduction of fracture healing complications in and of themselves may be sufficient primary study endpoints for a phase 3 pivotal study, acceleration of fracture union alone is not. Radiographic evaluation may either occur at multiple time points during the healing process with the aim of measuring the time taken to reach a defined status (e.g. cortical bridging of three cortices or disappearance of fracture lines), or could be obtained at a single pre-determined timepoint, were patients are expected to reach a common clinical milestone (i.e. pain free full weight-bearing in weight-bearing fracture cases). Validated Patient Reported Outcomes (PRO's) measures will need to support the return to normal function co-primary endpoints. If reduction of complication rate (e.g. non-union) is the primary objective, the anticipated complications must be defined in the study protocol, along with their possible associations with the specified fracture type and fixation device. The study design should be randomized, parallel, double-blind, and placebo-controlled, and all fracture subjects should receive a standardized method of fracture fixation, defined as Standard of Care.",2008,"If reduction of complication rate (e.g. non-union) is the primary objective, the anticipated complications must be defined in the study protocol, along with their possible associations with the specified fracture type and fixation device.","['patients with meta- and diaphyseal fractures', 'patients with osteoporosis or patients with other risks for impaired fracture union (e.g. in subjects with large defects or open fractures with high complication rate', 'patients with osteoporosis']",['placebo'],"['fracture healing complications', 'complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0016662', 'cui_str': 'Fractures, Compound'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.0249113,"If reduction of complication rate (e.g. non-union) is the primary objective, the anticipated complications must be defined in the study protocol, along with their possible associations with the specified fracture type and fixation device.","[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Goldhahn', 'Affiliation': 'Schulthess Clinic Zurich and Clinical Priority Program ""Fracture Fixation in Osteoporotic, Bone"" of AO Foundation, Davos, Switzerland. Electronic address: joerg.goldhahn@kws.ch.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'Scheele', 'Affiliation': 'Wyeth Research, Cambridge, MA, USA.'}, {'ForeName': 'Bruce H', 'Initials': 'BH', 'LastName': 'Mitlak', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Abadie', 'Affiliation': ""Département de l'Enregistrement et des Etudes Cliniques, AFSSAPS, Saint Denis, France.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Aspenberg', 'Affiliation': 'Division of Orthopedics and Sports Medicine, Department of Neuroscience and Locomotion, Faculty of Health Sciences, Linköping University, Linkoping, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Augat', 'Affiliation': 'Biomechanics Laboratory Paracelsus Medical University, Salzburg, Austria; Biomechanics Laboratory Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Maria-Luisa', 'Initials': 'ML', 'LastName': 'Brandi', 'Affiliation': 'Metabolic Bone Unit, Laboratory of Molecular Genetics, Department of Internal Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Nansa', 'Initials': 'N', 'LastName': 'Burlet', 'Affiliation': 'International Osteoporosis Foundation, Nyon, Switzerland.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Wyeth Research, Cambridge, MA, USA.'}, {'ForeName': 'Pierre D', 'Initials': 'PD', 'LastName': 'Delmas', 'Affiliation': 'Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Dupin-Roger', 'Affiliation': 'IRIS-Servier, Paris, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Ethgen', 'Affiliation': 'Clinical Development, GSK, Philadelphia, PA, USA.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Hanson', 'Affiliation': 'AO Clinical Investigation and Documentation, Davos Platz, Davos, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Hartl', 'Affiliation': 'F. Hoffmann-La Roche AG, Basel, Switzerland.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kanis', 'Affiliation': 'Centre for Metabolic Bone Diseases (WHO Collaborating Centre), University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Kewalramani', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Laslop', 'Affiliation': 'AGES PharmMed, Vienna, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Marsh', 'Affiliation': ""Queen's University Belfast, Division of Surgery and Perioperative Care, Department of Orthopaedic Surgery, Musgrave Park Hospital, Stockman's Lane, Belfast, Ulster, UK.""}, {'ForeName': 'Sif', 'Initials': 'S', 'LastName': 'Ormarsdottir', 'Affiliation': 'Senior Expert, Icelandic Medicines Control Agency, Seltjarnarnes, Iceland.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Rizzoli', 'Affiliation': ""Centre Collaborateur de l'Oms pour la prevention de l'osteoporose, Geneva, Switzerland.""}, {'ForeName': 'Art', 'Initials': 'A', 'LastName': 'Santora', 'Affiliation': 'Merck & Co., Whitehouse Station, NJ, USA.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schmidmaier', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wagener', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'Department of Public Health Sciences, University of Liège, Liège, Belgium, Chairman GREES, President ESCEO.'}]",Bone,['10.1016/j.bone.2008.04.017']
114,18502162,Long-term follow-up of endurance and safety outcomes during enzyme replacement therapy for mucopolysaccharidosis VI: Final results of three clinical studies of recombinant human N-acetylgalactosamine 4-sulfatase.,"UNLABELLED


The objective of this study was to evaluate the long-term clinical benefits and safety of recombinant human arylsulfatase B (rhASB) treatment of mucopolysaccharidosis type VI (MPS VI: Maroteaux-Lamy syndrome), a lysosomal storage disease. Fifty-six patients derived from 3 clinical studies were followed in open-label extension studies for a total period of 97-260 Weeks. All patients received weekly infusions of rhASB at 1 mg/kg. Efficacy was evaluated by (1) distance walked in a 12-minute walk test (12MWT) or 6-minute walk test (6MWT), (2) stairs climbed in the 3-minute stair climb (3MSC), and (3) reduction in urinary glycosaminoglycans (GAG). Safety was evaluated by compliance, adverse event (AE) reporting and adherence to treatment.
RESULTS


A significant reduction in urinary GAG (71-79%) was sustained. For the 12MWT, subjects in Phase 2 showed improvement of 255+/-191 m (mean+/-SD) at Week 144; those in Phase 3 Extension demonstrated improvement from study baseline of 183+/-26 m (mean+/- SE) in the rhASB/rhASB group at Week 96 and from treatment baseline (Week 24) of 117+/-25 m in the placebo/rhASB group. The Phase 1/2 6MWT and the 3MSC from Phase 2 and 3 also showed sustained improvements through the final study measurements. Compliance was 98% overall. Only 560 of 4121 reported AEs (14%) were related to treatment with only 10 of 560 (2%) described as severe.
CONCLUSION


rhASB treatment up to 5 years results in sustained improvements in endurance and has an acceptable safety profile.",2008,The Phase 1/2 6MWT and the 3MSC from Phase 2 and 3 also showed sustained improvements through the final study measurements.,['mucopolysaccharidosis VI'],"['recombinant human arylsulfatase B (rhASB', 'recombinant human N-acetylgalactosamine 4-sulfatase', 'rhASB', 'enzyme replacement therapy', 'placebo/rhASB']","['distance walked in a 12-minute walk test (12MWT) or 6-minute walk test (6MWT), (2) stairs climbed in the 3-minute stair climb (3MSC), and (3) reduction in urinary glycosaminoglycans (GAG', 'Efficacy', 'severe', 'compliance, adverse event (AE) reporting and adherence to treatment', 'urinary GAG']","[{'cui': 'C0026709', 'cui_str': 'Maroteaux-Lamy Syndrome'}]","[{'cui': 'C3657208', 'cui_str': 'ARSB protein, human'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376159', 'cui_str': 'Arylsulfatase B'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0573708,The Phase 1/2 6MWT and the 3MSC from Phase 2 and 3 also showed sustained improvements through the final study measurements.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harmatz', 'Affiliation': ""Children's Hospital & Research Center Oakland, 747 52nd Street, Oakland, CA 94609, USA.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Giugliani', 'Affiliation': 'Serviço de Genética Médica/HCPA and Department of Genetics/UFRGS, Porto Alegre, Brazil.'}, {'ForeName': 'Ida Vanessa', 'Initials': 'IV', 'LastName': 'D Schwartz', 'Affiliation': 'Serviço de Genética Médica/HCPA and Department of Genetics/UFRGS, Porto Alegre, Brazil.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Guffon', 'Affiliation': 'Hôpital Edouard Herriot Pavillon S, Maladies Metaboliques, Lyon, France.'}, {'ForeName': 'Elisa Leão', 'Initials': 'EL', 'LastName': 'Teles', 'Affiliation': 'Unidade de Doenças Metabólicas, Departamento Pediatria, Hospital de Sao João, Porto, Portugal.'}, {'ForeName': 'M Clara Sá', 'Initials': 'MCS', 'LastName': 'Miranda', 'Affiliation': 'Unidade de Biologia do Lisossoma e Peroxisoma, Instituto de Biologia Molecular e Celular, Porto, Portugal.'}, {'ForeName': 'J Edmond', 'Initials': 'JE', 'LastName': 'Wraith', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beck', 'Affiliation': ""Children's Hospital, University of Mainz, Germany.""}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Arash', 'Affiliation': ""Children's Hospital, University of Mainz, Germany.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Scarpa', 'Affiliation': 'Department of Pediatrics, University of Padova, Padova, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ketteridge', 'Affiliation': ""Department of Genetic Medicine, Women's and Children's Hospital Adelaide, North Adelaide, Australia.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Hopwood', 'Affiliation': ""Department of Genetic Medicine, Women's and Children's Hospital Adelaide, North Adelaide, Australia.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Plecko', 'Affiliation': 'Univ. Klinik fur Kinder und Jugendheilkunde, Graz, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Steiner', 'Affiliation': 'Departments of Pediatrics and Molecular and Medical Genetics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Chester B', 'Initials': 'CB', 'LastName': 'Whitley', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Kaplan', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Zi-Fan', 'Initials': 'ZF', 'LastName': 'Yu', 'Affiliation': 'Statistics Collaborative, Inc., Washington, DC, USA.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Swiedler', 'Affiliation': 'BioMarin Pharmaceutical Inc, Novato, CA, USA.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Decker', 'Affiliation': 'BioMarin Pharmaceutical Inc, Novato, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2008.04.001']
115,31776116,Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care.,,2021,,['gout flares in primary care'],['naproxen and low-dose colchicine'],[],"[{'cui': 'C1619733', 'cui_str': 'Gout flare'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}]",[],,0.0775983,,"[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Parperis', 'Affiliation': 'Internal Medicine, Division of Rheumatology, University of Cyprus Medical School, Nicosia, Cyprus kparpe02@ucy.ac.cy.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216643']
116,18602687,Vitespen: a vaccine for renal cancer?,,2008,,[],[],[],[],[],[],,0.0211121,,"[{'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Surgery Branch, National Cancer Institute, Bethesda, MD 20892, USA. Electronic address: jamesyang@mail.nih.gov.'}]","Lancet (London, England)",['10.1016/S0140-6736(08)60698-4']
117,18395480,Efficacy and safety of individualized growth hormone treatment in adult Japanese patients with growth hormone deficiency.,"OBJECTIVE


The aim of the study was to evaluate the efficacy and safety of growth hormone (GH) treatment in Japanese adult patients with GH-deficiency. In the extension of the efficacy study, the effect of individualized-dosing (ID), based on insulin-like growth factor-I (IGF-I) levels, and fixed-dose (FD) GH regimens on body composition, were compared in Japanese GH-deficient adults.
DESIGN


Randomized, double-blind (DB), placebo-controlled, 24-week treatment period followed by 48-week, open-label study in 43 endocrinology clinics in Japan. Patients received DB treatment with GH (0.012 mg/kg/day; n=57) or placebo (n=60) followed by open-label GH in an ID (n=75) or FD (0.012 mg/kg/day; n=38) regimen.
SUBJECTS


Adult Japanese GH-deficient patients (peak GH<3 ng/mL).
MEASUREMENTS


Trunk and total body fat (BF), lean body mass (LBM), and adverse events were determined.
RESULTS


Percentage trunk fat was reduced significantly more in GH- than in placebo-treated patients at 24 weeks (-16.2 vs. 1.7%, p<0.0001). Open-label treatment with an ID or FD GH regimen provided similar reductions in percentage trunk fat (-8.12 vs. -9.35%), and total BF (-0.92 vs. -0.70 kg) and a comparable increase in LBM (1.032 vs. 0.97 kg). Mean+/-SD GH doses (mg/kg/day) at 48 weeks were significantly lower with the ID GH regimen (ID, 0.0082+/-0.0050; FD, 0.0095+/-0.0033; p<0.05). The safety profile was comparable between ID and FD groups.
CONCLUSIONS


Treatment with GH was associated with a significant reduction in trunk fat and improvement in serum lipid profile in Japanese adult GH-deficient patients. The improvement in body composition and tolerability were comparable between ID and FD GH regimens despite a significantly lower daily GH dose with the ID regimen.",2008,"RESULTS


Percentage trunk fat was reduced significantly more in GH- than in placebo-treated patients at 24 weeks (-16.2 vs. 1.7%, p<0.0001).","['Japanese GH-deficient adults', 'Japanese adult GH-deficient patients', 'Adult Japanese GH-deficient patients (peak GH<3 ng/mL', 'Japanese adult patients with GH-deficiency', 'adult Japanese patients with growth hormone deficiency', '43 endocrinology clinics in Japan']","['FD GH regimen', 'growth hormone (GH', 'placebo', 'individualized growth hormone treatment', 'open-label GH in an ID (n=75) or FD', 'individualized-dosing (ID), based on insulin-like growth factor-I (IGF-I) levels, and fixed-dose (FD) GH regimens', 'Mean+/-SD GH', 'GH']","['Efficacy and safety', 'efficacy and safety', 'serum lipid profile', 'safety profile', 'body composition and tolerability', 'total BF', 'LBM', 'percentage trunk fat', 'Trunk and total body fat (BF), lean body mass (LBM), and adverse events', 'Percentage trunk fat']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency (disorder)'}, {'cui': 'C3810855', 'cui_str': 'Endocrinology clinic'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0688372,"RESULTS


Percentage trunk fat was reduced significantly more in GH- than in placebo-treated patients at 24 weeks (-16.2 vs. 1.7%, p<0.0001).","[{'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Chihara', 'Affiliation': 'Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yuzuru', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Department of Medicine, Shimane University, Izumo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shimatsu', 'Affiliation': 'Clinical Research Center for Endocrine and Metabolic Disease, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Laboratory Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kohno', 'Affiliation': ""Department of Endocrinology and Metabolism, Fukuoka Children's Hospital, Fukuoka, Japan.""}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2008.02.002']
118,18299182,Prophylactic octreotide and delayed gastric emptying after pancreaticoduodenectomy: results of a prospective randomized double-blinded placebo-controlled trial.,"AIMS


To evaluate the impact of prophylactic octreotide on gastric emptying in patients undergoing pancreaticoduodenectomy. Postoperative pancreatic fistula (POPF) and delayed gastric emptying (DGE) are common complications after pancreaticoduodenectomy. Whereas several prospective randomized trials propose the prophylactic use of octreotide to prevent pancreatic fistula formation, somatostatin has, however, been associated with delayed gastric emptying after partial duodenopancreatectomy.
METHODS


In this prospective, randomized, double-blinded, placebo-controlled trial we analyzed the influence of prophylactic octreotide on delayed gastric empting after pancreaticoduodenectomy. Patients were randomized to the placebo group (n=32) and the octreotide group (n=35). Primary endpoint was the incidence of delayed gastric emptying, secondary endpoints included perioperative morbidity other than DGE. DGE was measured by clinical signs, gastric scintigraphy and the hydrogen breath test. Risk factors for DGE other than octreotide were analyzed by univariate and multivariate analyses.
RESULTS


DGE measured by clinical signs was similar between both groups studied ( approximately 20% of the patients). Gastric scintigraphy (T(1/2)) was 76.3+/-15.2 min in the octreotide group and 86.7+/-18.0 min in controls at day 7, respectively. The H(2) breath test was 65.0+/-6.5 min in octreotide treatment group and 67.0+/-5.7 min in controls at day 8. POPF grade C occurred in approximately 3% of the patients, although prophylactic treatment of octreotide did not reduce the incidence of POPF. Multivariate analysis showed that postoperative intraabdominal bleeding and infection were independent risk factors for DGE. Furthermore preoperative biliary stenting reduced postoperative DGE after partial duodenopancreatectomy.
CONCLUSION


Prophylactic octreotide has no influence on gastric emptying and does not decrease the incidence of postoperative pancreatic fistula after pancreaticoduodenectomy.",2008,"CONCLUSION


Prophylactic octreotide has no influence on gastric emptying and does not decrease the incidence of postoperative pancreatic fistula after pancreaticoduodenectomy.","['patients undergoing pancreaticoduodenectomy', 'delayed gastric empting after pancreaticoduodenectomy']","['prophylactic octreotide', 'placebo', 'Prophylactic octreotide', 'octreotide', 'pancreaticoduodenectomy']","['incidence of POPF', 'postoperative intraabdominal bleeding and infection', 'DGE', 'clinical signs, gastric scintigraphy and the hydrogen breath test', 'DGE measured by clinical signs', 'incidence of delayed gastric emptying', 'Gastric scintigraphy (T(1/2', 'H(2) breath test', 'Postoperative pancreatic fistula (POPF) and delayed gastric emptying (DGE', 'gastric emptying', 'POPF grade C', 'delayed gastric emptying', 'perioperative morbidity other than DGE', 'postoperative pancreatic fistula']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0344439', 'cui_str': 'Hydrogen breath test (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0006153', 'cui_str': 'Breath Tests'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0441807', 'cui_str': 'Grade C (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.458768,"CONCLUSION


Prophylactic octreotide has no influence on gastric emptying and does not decrease the incidence of postoperative pancreatic fistula after pancreaticoduodenectomy.","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Kollmar', 'Affiliation': 'Department of General, Visceral, Vascular and Pediatric Surgery, Kirrbergerstr, University of Saarland, D-66421 Homburg/Saar, Germany.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Moussavian', 'Affiliation': 'Department of General, Visceral, Vascular and Pediatric Surgery, Kirrbergerstr, University of Saarland, D-66421 Homburg/Saar, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Richter', 'Affiliation': 'Department of General, Visceral, Vascular and Pediatric Surgery, Kirrbergerstr, University of Saarland, D-66421 Homburg/Saar, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'de Roi', 'Affiliation': 'Department of General, Visceral, Vascular and Pediatric Surgery, Kirrbergerstr, University of Saarland, D-66421 Homburg/Saar, Germany.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Maurer', 'Affiliation': 'Department of Surgery, Hospital of Liestal, CH-4410 Liestal, Switzerland.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Schilling', 'Affiliation': 'Department of General, Visceral, Vascular and Pediatric Surgery, Kirrbergerstr, University of Saarland, D-66421 Homburg/Saar, Germany. Electronic address: martin.schilling@uniklinikum-saarland.de.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2008.01.014']
119,18194848,No association of the POLI Thr706Ala polymorphism with the risk of cervical carcinoma.,"OBJECTIVE


To investigate the association of repair gene POLI genetic polymorphisms with cervical carcinoma.
MATERIALS AND METHODS


Four hundred sixty one cervical carcinoma patients and 628 normal women were randomly selected for this study. Single nucleotide polymorphisms (SNPs) (POLI Thr706Ala) were genotyped, and the epidemiological risk factor was assessed.
RESULTS


Compared with the POLI Thr706Thr genotype, neither POLI Thr706Ala nor POLI Ala706Ala elevated or decreased the risk of cervical carcinoma or cervical squamous cell carcinoma [ORs and 95% CIs 1.25(0.97-1.61), 1.11(0.67-1.83), 1.22(0.94-1.58), 1.06(0.63-1.78), respectively]. When analyzing the risk of the POLI Thr706Ala variant genotype for cervical carcinoma in different histological types or HPV infection status, very similar risk factors were observed for the squamous cell carcinoma group or the HPV positive group to the overall carcinoma. Regardless of sexual or reproductive histories, patients with the POLI Thr706Ala or POLI Ala706Ala genotype showed a significantly increased risk of cervical carcinoma.
CONCLUSION


The POLI Thr706Ala genotype was not associated with cervical carcinoma in a Chinese population, but we cannot exclude the possibility that the POLI polymorphism might be associated with sexual and reproductive history.",2008,"Ala706Ala elevated or decreased the risk of cervical carcinoma or cervical squamous cell carcinoma [ORs and 95% CIs 1.25(0.97-1.61), 1.11(0.67-1.83)",['Four hundred sixty one cervical carcinoma patients and 628 normal women'],"['POLI', 'Thr706Ala or POLI']","['risk of cervical carcinoma or cervical squamous cell carcinoma', 'risk of cervical carcinoma', 'POLI Thr706Ala nor POLI']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix (disorder)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}]",461.0,0.0607048,"Ala706Ala elevated or decreased the risk of cervical carcinoma or cervical squamous cell carcinoma [ORs and 95% CIs 1.25(0.97-1.61), 1.11(0.67-1.83)","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Xueshi Road #2, Hangzhou, Zhejiang 310006, China. Electronic address: zhangjyy@hotmail.com.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': ""Women's Reproductive Health Laboratory of Zhejiang Province, Women's Hospital, School of Medicine, Zhejiang University, Xueshi Road #2, Hangzhou, Zhejiang 310006, China. Electronic address: yefyef@zju.edu.cn.""}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Cheng', 'Affiliation': ""Women's Reproductive Health Laboratory of Zhejiang Province, Women's Hospital, School of Medicine, Zhejiang University, Xueshi Road #2, Hangzhou, Zhejiang 310006, China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': ""Women's Reproductive Health Laboratory of Zhejiang Province, Women's Hospital, School of Medicine, Zhejiang University, Xueshi Road #2, Hangzhou, Zhejiang 310006, China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Women's Reproductive Health Laboratory of Zhejiang Province, Women's Hospital, School of Medicine, Zhejiang University, Xueshi Road #2, Hangzhou, Zhejiang 310006, China. Electronic address: chenhz@zju.edu.cn.""}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2007.11.008']
120,32504217,Cleansing efficacy of an auto-cleaning electronic toothbrushing device: a randomized-controlled crossover pilot study.,"OBJECTIVES


To compare the cleansing efficacy of a representative ""ten seconds"" auto-cleaning device with that of uninstructed manual toothbrushing in a pilot study.
MATERIALS AND METHODS


Twenty periodontally healthy probands refrained from oral hygiene for 3 days. Baseline full-mouth plaque scores (Rustogi Modified Navy Plaque Index, RMNPI) were assessed. After randomization, probands cleaned their teeth either with the auto-cleaning test device according to the manufacturer's protocol or with a manual toothbrush. Plaque reduction was assessed by two aligned blinded investigators. After a 2-week recovery, the clinical investigation was repeated in a crossover design. The brushing pattern of the auto-cleaning device was analyzed in probands' casts.
RESULTS


Full-mouth plaque reduction was 11.37 ± 3.70% for the auto-cleaning device and 31.39 ± 5.27% for manual toothbrushing (p < 0.0001). The investigation of the auto-cleaning device's brushing pattern in dental casts revealed a positive relationship of bristle rows in contact with tooth surfaces and the cleansing efficacy in the respective areas. A maximum of 2/4 bristle rows were in contact with the tooth surfaces; in some areas, the bristles had no contact to the teeth.
CONCLUSIONS


Uninstructed manual toothbrushing is superior to auto-cleaning. The alignment and density of the auto-cleaning device's bristle rows need to be improved, and assorted sizes would be necessary to cover different jaw shapes.
CLINICAL RELEVANCE


The auto-cleaning device has been developed to accommodate individuals with poor dexterity or compliance. To date, it is unable to provide sufficient plaque reduction due to an inappropriate bristle alignment and poor fit with diverse dental arches.",2021,"RESULTS


Full-mouth plaque reduction was 11.37 ± 3.70% for the auto-cleaning device and 31.39 ± 5.27% for manual toothbrushing (p < 0.0001).",['Twenty periodontally healthy probands refrained from oral hygiene for 3\xa0days'],"['representative ""ten seconds"" auto-cleaning device with that of uninstructed manual toothbrushing', 'auto-cleaning electronic toothbrushing device']","['Plaque reduction', 'Cleansing efficacy', 'Full-mouth plaque reduction', 'cleansing efficacy', 'Baseline full-mouth plaque scores (Rustogi Modified Navy Plaque Index, RMNPI']","[{'cui': 'C0702111', 'cui_str': 'Proband'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",20.0,0.0681159,"RESULTS


Full-mouth plaque reduction was 11.37 ± 3.70% for the auto-cleaning device and 31.39 ± 5.27% for manual toothbrushing (p < 0.0001).","[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Schnabl', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Wiesmüller', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Hönlinger', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wimmer', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Bruckmoser', 'Affiliation': 'Private Practice for Oral and Maxillofacial Surgery, 5020, Salzburg, Austria.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Kapferer-Seebacher', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria. Ines.Kapferer@i-med.ac.at.'}]",Clinical oral investigations,['10.1007/s00784-020-03359-5']
121,32441557,Lung function changes in patients with chronic obstructive pulmonary disease (COPD) and asthma exposed to secondhand smoke in outdoor areas.,"BACKGROUND


Further evidence is needed on the effects that short- and long-term exposure to secondhand smoke (SHS) have on the respiratory health of patients with lung disease. Within the TackSHS project we aimed to assess the acute respiratory effects in lung function that result from short-term SHS exposure among patients with asthma and chronic obstructive pulmonary disease (COPD).
METHODS


The study design was an intervention trial with measurements before/after exposure to SHS in legal outdoor smoking areas. We studied patients with asthma or COPD from Czechia, Ireland, and Spain. Forced spirometry, peak flow and carbon monoxide (CO) measurements were performed pre- and 24 h post- exposure.
RESULTS


Overall, 60 patients were studied, 30 with asthma, and 30 with COPD; 35 (58.3%) were female. There were no significant differences observed in exhaled CO between pre- and 24 h post-exposure neither in women ( p  = 0.210), nor in men ( p  = 0.169).A statistically significant decrease in forced vital capacity (FVC) was seen, overall, in asthma participants ( p  = 0.02) and in forced expiratory volume in the first second (FEV 1 ), ( p  = 0.02), FVC ( p  = 0.04) and peak expiratory flow rate (PEFR) ( p  = 0.04) in female asthmatic participants. The observed decreases in respiratory measurements in COPD were not significant. There were no reported increases in symptoms, respiratory medication, or use of health services 24 h after the exposure.
CONCLUSION


We conclude that acute, short-term SHS exposure had a statistically significant effect on spirometry in female asthma patients but did not significantly modify spirometric indices 24 h later in COPD patients.",2021,"There were no significant differences observed in exhaled CO between pre- and 24 h post-exposure neither in women ( p  = 0.210), nor in men ( p  = 0.169).A statistically significant decrease in forced vital capacity (FVC) was seen, overall, in asthma participants ( p  = 0.02) and in forced expiratory volume in the first second (FEV 1 ), ( p  = 0.02), FVC ( p  = 0.04) and peak expiratory flow rate (PEFR) ( p  = 0.04) in female asthmatic participants.","['patients with lung disease', 'patients with asthma or COPD from Czechia, Ireland, and Spain', 'patients with chronic obstructive pulmonary disease (COPD) and asthma exposed to secondhand smoke in outdoor areas', 'legal outdoor smoking areas', 'patients with asthma and chronic obstructive pulmonary disease (COPD', 'female asthmatic participants', '60 patients were studied, 30 with asthma, and 30 with COPD; 35 (58.3%) were female', 'female asthma patients']",[],"['exhaled CO', 'forced vital capacity (FVC', 'forced expiratory volume', 'respiratory measurements in COPD', 'Forced spirometry, peak flow and carbon monoxide (CO) measurements', 'peak expiratory flow rate (PEFR', 'symptoms, respiratory medication, or use of health services', 'FVC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0429673', 'cui_str': 'Respiratory measure'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0857465', 'cui_str': 'Peak flow'}, {'cui': 'C0201932', 'cui_str': 'Carboxyhemoglobin measurement'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0418986', 'cui_str': 'Respiratory medication'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",60.0,0.0434038,"There were no significant differences observed in exhaled CO between pre- and 24 h post-exposure neither in women ( p  = 0.210), nor in men ( p  = 0.169).A statistically significant decrease in forced vital capacity (FVC) was seen, overall, in asthma participants ( p  = 0.02) and in forced expiratory volume in the first second (FEV 1 ), ( p  = 0.02), FVC ( p  = 0.04) and peak expiratory flow rate (PEFR) ( p  = 0.04) in female asthmatic participants.","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Keogan', 'Affiliation': 'TobaccoFree Research Institute Ireland, Focas Research Institute, DIT, Dublin, Ireland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Alonso', 'Affiliation': 'Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Salome', 'Initials': 'S', 'LastName': 'Sunday', 'Affiliation': 'TobaccoFree Research Institute Ireland, Focas Research Institute, DIT, Dublin, Ireland.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Tigova', 'Affiliation': 'Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Esteve', 'Initials': 'E', 'LastName': 'Fernández', 'Affiliation': 'Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'López', 'Affiliation': 'Agència de Salut Pública de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Silvano', 'Initials': 'S', 'LastName': 'Gallus', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'Institute for Social Marketing, University of Stirling, Stirling, Scotland, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Tzortzi', 'Affiliation': 'Institute of Public Health of the American College of Greece, Athens, Greece.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Boffi', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gorini', 'Affiliation': 'Istituto per lo Studio, la Prevenzione e la Rete Oncologica, Florence, Italy.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'López-Nicolás', 'Affiliation': 'Universidad Politécnica de Cartagena, Cartagena, Spain.'}, {'ForeName': 'Cornel', 'Initials': 'C', 'LastName': 'Radu-Loghin', 'Affiliation': 'European Network for Smoking and Tobacco Prevention, Brussels, Belgium.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Soriano', 'Affiliation': 'Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Clancy', 'Affiliation': 'TobaccoFree Research Institute Ireland, Focas Research Institute, DIT, Dublin, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1766062']
122,32497783,Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART).,"BACKGROUND


There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM).
METHODS


In this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
RESULTS


At least 296 participants and approximately 75 peer supporters will be enrolled.
DISCUSSION


Despite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03689530.",2020,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","['296 adults with prediabetes', 'At least 296 participants and approximately 75 peer supporters will be enrolled']","['peer support arm or enhanced usual care', 'peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan']","['Changes in A1c, weight, waist circumference', 'health behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",296.0,0.0609549,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America. Electronic address: mheisler@umich.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kullgren', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America. Electronic address: jkullgre@med.umich.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: caroli@umich.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Stoll', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: scstoll@umich.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alvarado Nieves', 'Affiliation': 'University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology and Diabetes, United States of America. Electronic address: alvaradc@med.umich.edu.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: deanne.wiley@kp.org.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Sedgwick', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Tali.S.Sedgwick@kp.org.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Alyce.S.Adams@kp.org.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hedderson', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Monique.m.hedderson@kp.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: Eileen.Kim@kp.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: megan.rao@kp.org.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Julie.A.Schmittdiel@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106048']
123,31424302,"Effectiveness of using assistive technology for time orientation and memory, in older adults with or without dementia.","AIMS


The purposes of this study were to reveal the effectiveness of an electric calendar, showing the date and schedule automatically for older people, and to prove the characteristics of appropriate users.
MATERIAL AND METHODS


The participants were 27 older adults with or without dementia (9 men and 18 women, mean age: 81.5 ± 6.9 years, range: 72-94 years). The study design was a cross-over randomized controlled trial, with 15 participants (55.6%) allocated to the first group to use the electric calendar, and 12 participants (44.4%) to the second intervention group. The outcome measures are daily behaviors and cognitive function assessed by the Mini-Mental State Examination and Neurobehavioral Cognitive Status Examination.
RESULTS


Participants showed significant increase in total Mini-Mental State Examination score ( p  = 0.020, a paired  t -test) after intervention period, whereas there was no significant difference after no intervention. Daily activities related healthcare were improved. The participants with positive outcomes showed higher motivations, and around 18 points in Mini-Mental State Examination. Most healthy older adults mentioned that electric calendars were useful, but unnecessary.
CONCLUSION AND SIGNIFICANCE


Using the electric calendar was effective in improving global cognitive function and daily activities. The target users are older people, who (1) might have mild dementia, (2) have difficulties in daily activities, (3) can be supported by caregivers, and (4) have positive motivation to new technologies.IMPLICATIONS FOR REHABILITATIONAn electric calendar is effective on grovel cognitive function, and activities of daily living related to healthcare in older adults, as well as reality orientation therapy.The electric calendar can be useful for older people with mild dementia or mild cognitive impairment, having difficulties activities of daily living, supported by caregivers at regular intervals.",2021,"The electric calendar can be useful for older people with mild dementia or mild cognitive impairment, having difficulties activities of daily living, supported by caregivers at regular intervals.","['27 older adults with or without dementia (9 men and 18 women, mean age: 81.5\u2009±\u20096.9\u2009years, range: 72-94\u2009years', 'older adults with or without dementia', 'healthy older adults', 'older people with mild dementia or mild cognitive impairment', '15 participants (55.6%) allocated to the first group to use the electric calendar, and 12 participants (44.4%) to the second intervention group', 'older adults', 'older people']",['assistive technology'],"['daily behaviors and cognitive function assessed by the Mini-Mental State Examination and Neurobehavioral Cognitive Status Examination', 'Daily activities related healthcare', 'total Mini-Mental State Examination score', 'grovel cognitive function, and activities of daily living', 'global cognitive function and daily activities']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0036605', 'cui_str': 'Assistive Technology'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0475497', 'cui_str': 'Neurobehavioral Cognitive Status Examination'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",27.0,0.0753791,"The electric calendar can be useful for older people with mild dementia or mild cognitive impairment, having difficulties activities of daily living, supported by caregivers at regular intervals.","[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Nishiura', 'Affiliation': 'Department of Assistive Technology, National Rehabilitation Centre for Persons with Disabilities, Saitama, Japan.'}, {'ForeName': 'Misato', 'Initials': 'M', 'LastName': 'Nihei', 'Affiliation': 'Graduate School of Frontier Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Nakamura-Thomas', 'Affiliation': 'Department of Occupational Therapy, Saitama Prefectural University, Saitama, Japan.'}, {'ForeName': 'Takenobu', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Assistive Technology, National Rehabilitation Centre for Persons with Disabilities, Saitama, Japan.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2019.1650299']
124,32139353,Exercise and the Kynurenine pathway: Current state of knowledge and results from a randomized cross-over study comparing acute effects of endurance and resistance training.,"INTRODUCTION


The essential amino acid tryptophan (TRP) is primarily degraded through the kynurenine (KYN) pathway, which is dysregulated in several chronic diseases. KYN pathway metabolites have immune- and neuro-modulatory properties and are involved in th de novo synthesis of nicotinamide adenine dinucleotide (NAD+). Currently, little evidence exists demonstrating that physical exercise may influence this pathway. However, differences between acute and chronic stimuli as well as the influence of exercise modalities remain to be investigated. Here, we provide an overview of existing studies and present results of a randomized cross-over trial on acute effects of a single-bout of resistance and endurance exercise.
METHODS


24 healthy male adults conducted both an acute endurance exercise (EE) and resistance exercise (RE) session. Blood samples were collected before, immediately after and one hour after cessation of each exercise session. Outcomes comprised serum levels of TRP, KYN, kynurenic acid (KA), quinolinic acid (QA) and calculated ratios. Gene expression of the enzymes indoleamine 2,3 dioxygenase (IDO) 1 and kynurenine aminotransferase (KAT) 4 was measured in peripheral blood mononuclear cells (PBMCs). Moreover, serum concentrations of the potential KYN pathway mediators interleukin (IL)-6 and cortisol were determined. Finally, we investigated baseline correlations between immune cell subsets, potential mediators and initial KYN pathway activation outcomes.
RESULTS


The KYN/TRP ratio correlated positively with IL-6 and CD56bright NK-cells and negatively with CD56dim NKcells. Expression of IDO1 in PBMCs correlated positively with IL-6, regulatory T-cells and CD56bright NK-cells, whereas negative correlations to cytotoxic T-cells and CD56dim NKcells were revealed. A significant time effect on KYN/TRP ratio was detected for RE. Regarding KA and KA/KYN ratio, an increase after exercise followed by a decrease at the follow- up measurement was revealed in EE. KAT4 expression also increased after exercise in EE. Moreover, elevated QA levels were observed after the EE session.
CONCLUSIONS


In contrast to chronic exercise interventions, single-bouts of endurance exercise provoke acute alterations on KYN pathway outcomes in humans. Our results indicate that EE induces stronger alterations than RE. Enhanced conversion of KYN to both, KA and QA suggest a peripheral KYN clearance, thereby preventing pathological accumulation within the CNS. Future acute and chronic exercise studies are needed to examine the role of NAD+ synthesis starting with TRP and the interplay between KYN pathway activation and mid- to long-term immunological modulations.",2020,". Expression of IDO1 in PBMCs correlated positively with IL-6, regulatory T-cells and CD56bright NK-cells, whereas negative correlations to cytotoxic T-cells and CD56dim NKcells were revealed.","['humans', '24 healthy male adults']","['Kynurenine pathway', 'acute endurance exercise (EE) and resistance exercise (RE) session', 'acid tryptophan (TRP', 'endurance and resistance training']","['Gene expression of the enzymes indoleamine 2,3 dioxygenase (IDO', '1 and kynurenine aminotransferase (KAT', 'serum levels of TRP, KYN, kynurenic acid (KA), quinolinic acid (QA) and calculated ratios', 'elevated QA levels', 'KAT4 expression', 'peripheral blood mononuclear cells (PBMCs', 'IL-6, regulatory T-cells and CD56bright NK-cells', 'serum concentrations of the potential KYN pathway mediators interleukin (IL)-6 and cortisol', 'IL-6 and CD56bright NK-cells and negatively with CD56dim NKcells', 'KYN/TRP ratio', 'TRP ratio']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0686751', 'cui_str': 'Well male adult (finding)'}]","[{'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C1564138', 'cui_str': 'Indoleamine-Pyrrole 2,3,-Dioxygenase'}, {'cui': 'C0064450', 'cui_str': '3-hydroxykynurenine transaminase'}, {'cui': 'C0439245', 'cui_str': 'kat'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022816', 'cui_str': '2-Quinolinecarboxylic acid, 4-hydroxy-'}, {'cui': 'C0072879', 'cui_str': '2,3-Pyridinedicarboxylic acid'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",24.0,0.0461894,". Expression of IDO1 in PBMCs correlated positively with IL-6, regulatory T-cells and CD56bright NK-cells, whereas negative correlations to cytotoxic T-cells and CD56dim NKcells were revealed.","[{'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Joisten', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kummerhoff', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Koliamitra', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schenk', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walzik', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Hardt', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Knoop', 'Affiliation': 'Center for Preventive Doping Research/Institute of Biochemistry, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Thevis', 'Affiliation': 'Center for Preventive Doping Research/Institute of Biochemistry, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kiesl', 'Affiliation': 'University Clinic for Hematology and Internal Oncology, Kepler University Hospital, Johannes Kepler University, Linz, Austria.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Metcalfe', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}]",Exercise immunology review,[]
125,31381020,Association of High-Dose Vitamin D Supplementation During Pregnancy With the Risk of Enamel Defects in Offspring: A 6-Year Follow-up of a Randomized Clinical Trial.,"Importance


Enamel defects of developmental origin affect up to 38% of schoolchildren and is recognized as a global public health challenge. The impaired enamel formation results in pain owing to hypersensitivity, posteruptive breakdowns, rapid caries progression, and extractions in some cases. The etiology is unknown; therefore, prevention is currently not possible.
Objective


To assess the association of a high-dose vitamin D supplementation in pregnant women with enamel defects and caries in their offspring.
Design, Setting, and Participants


Post hoc analysis of a double-blind, single-center, randomized clinical trial, the Copenhagen Prospective Studies on Asthma in Childhood 2010 cohort (COPSAC2010). Enrollment began March 2009 and included 623 women recruited at 24 weeks of pregnancy and 588 of their children. A dental examination was completed at age 6 years in 496 of 588 children (84%). Data were analyzed in 2018.
Intervention


High-dose vitamin D3 (2400 IU/d; N = 315) or matching placebo tablets (N = 308) from pregnancy week 24 to 1 week post partum. In addition, all women received 400 IU/d of vitamin D3 as part of standard care.
Main Outcomes and Measures


Enamel defect was defined as having at least 1 molar affected by demarcated opacity, enamel breakdown, and/or atypical restoration. Caries was defined as decayed, missing, or filled surfaces in both the deciduous and permanent dentitions (World Health Organization standard).
Results


The risk of enamel defects in the permanent dentition was lower in the offspring of mothers who received high-dose vitamin D supplementation during pregnancy compared with standard dose (15.1% [n = 26 of 172] vs 27.5% [n = 44 of 160]; odds ratio, 0.47; 95% CI, 0.27-0.81). A similar association was observed for the deciduous dentition (8.6% [n = 21 of 244] vs 15.9% [n = 40 of 252]; odds ratio, 0.50; 95% CI, 0.28-0.87). There was no association between supplementation and caries.
Conclusions and Relevance


High-dose vitamin D supplementation during pregnancy was associated with approximately 50% reduced odds of enamel defects in the offspring. This suggests prenatal vitamin D supplementation as a preventive intervention for enamel defects, with a clinically important association with dental health.
Trial Registration


ClinicalTrials.gov identifier: NCT00856947.",2019,"The risk of enamel defects in the permanent dentition was lower in the offspring of mothers who received high-dose vitamin D supplementation during pregnancy compared with standard dose (15.1% [n = 26 of 172] vs 27.5% [n = 44 of 160]; odds ratio, 0.47; 95% CI, 0.27-0.81).","['Offspring', 'A dental examination was completed at age 6 years in 496 of 588 children (84', 'Enrollment began March 2009 and included 623 women recruited at 24 weeks of pregnancy and 588 of their children', 'pregnant women with enamel defects and caries in their offspring']","['vitamin D supplementation', 'vitamin D3', 'High-Dose Vitamin D Supplementation', 'Intervention\n\n\nHigh-dose vitamin D3', 'matching placebo tablets', 'prenatal vitamin D supplementation']","['risk of enamel defects', 'deciduous dentition', 'Measures\n\n\nEnamel defect was defined as having at least 1 molar affected by demarcated opacity, enamel breakdown, and/or atypical restoration']","[{'cui': 'C0750862', 'cui_str': 'Dental examination'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1265876', 'cui_str': 'Abnormally opaque structure (morphologic abnormality)'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]",623.0,0.505528,"The risk of enamel defects in the permanent dentition was lower in the offspring of mothers who received high-dose vitamin D supplementation during pregnancy compared with standard dose (15.1% [n = 26 of 172] vs 27.5% [n = 44 of 160]; odds ratio, 0.47; 95% CI, 0.27-0.81).","[{'ForeName': 'Pia Elisabeth', 'Initials': 'PE', 'LastName': 'Nørrisgaard', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Haubek', 'Affiliation': 'Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kühnisch', 'Affiliation': 'Department of Operative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-Universität München, München, Germany.'}, {'ForeName': 'Bo Lund', 'Initials': 'BL', 'LastName': 'Chawes', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Stokholm', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Bønnelykke', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Bisgaard', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.2545']
126,32496365,Hemodynamic and Hemostatic Response to Blood Flow Restriction Resistance Exercise in Coronary Artery Disease: A Pilot Randomized Controlled Trial.,"BACKGROUND


Blood flow-restricted resistance training (BFR-RT) has been proven to be safe and efficacious in healthy older adults, but not in cardiovascular disease.
OBJECTIVE


The aim of this study was to investigate the acute and training induced effects of BFR-RT on hemostatic and hemodynamic responses in patients with coronary artery disease (CAD).
METHODS


Stable patients with CAD were randomized to 8 weeks of BFR-RT (30%-40% 1-repetition maximum unilateral knee extension) combined with aerobic training or aerobic training alone (control group). At baseline and after 4 and 8 weeks, blood samples were taken before and after BFR exercise, whereas hemodynamic parameters were monitored throughout the exercise.
RESULTS


Twenty-four patients (12 per group; mean age, 60 ± 2 years; mostly male [75%]) completed the study. The BFR-RT significantly improved systolic blood pressure (-10 mm Hg; P = .020) and tended to lower diastolic blood pressure (-2 mm Hg; P = .066). In contrast, no posttraining alterations were observed in N-terminal prohormone B-type natriuretic hormone, fibrinogen, and D-dimer values. During BFR exercise, all hemodynamic variables significantly increased after the first and second set, whereas blood pressure immediately lowered after the cuff was released in the third set. Last, significant interaction was only observed for repetitions × intensity (P < .001; partial η2 = 0.908) of diastolic blood pressure at higher exercise intensity (40% 1-repetition maximum).
CONCLUSIONS


The BFR-RT was proven to be safe, with favorable hemodynamic and hemostatic responses in patients with CAD, and can be recommended as an additional exercise modality in cardiac rehabilitation.Trial Registration:ClinicalTrial.gov Identifier: NCT03087292.",2021,The BFR-RT significantly improved systolic blood pressure (-10 mm Hg; P = .020) and tended to lower diastolic blood pressure (-2 mm Hg; P = .066).,"['Coronary Artery Disease', 'Twenty-four patients (12 per group; mean age, 60 ± 2 years; mostly male [75%]) completed the study', 'patients with coronary artery disease (CAD', 'healthy older adults', 'Stable patients with CAD', 'patients with CAD']","['BFR-RT', 'Blood flow-restricted resistance training (BFR-RT', 'Blood Flow Restriction Resistance Exercise', 'BFR-RT (30%-40% 1-repetition maximum unilateral knee extension) combined with aerobic training or aerobic training alone (control group']","['blood pressure', 'hemostatic and hemodynamic responses', 'systolic blood pressure', 'diastolic blood pressure', 'hemodynamic variables', 'hemodynamic parameters']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0569271,The BFR-RT significantly improved systolic blood pressure (-10 mm Hg; P = .020) and tended to lower diastolic blood pressure (-2 mm Hg; P = .066).,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Kambič', 'Affiliation': ''}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Novaković', 'Affiliation': ''}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Tomažin', 'Affiliation': ''}, {'ForeName': 'Vojko', 'Initials': 'V', 'LastName': 'Strojnik', 'Affiliation': ''}, {'ForeName': 'Mojca', 'Initials': 'M', 'LastName': 'Božič-Mijovski', 'Affiliation': ''}, {'ForeName': 'Borut', 'Initials': 'B', 'LastName': 'Jug', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000699']
127,32519208,Assessment of Psychosocial Functioning in a Large Cohort of Patients with Schizophrenia.,"BACKGROUND


This study addresses the question of whether psychosocial functioning measured by the Personal and Social Performance (PSP) Scale is related to various psychopathological measures in a cohort of patients with schizophrenia.
METHODS


The 'Neuroleptic Strategy Study' (NeSSy) performed at 14 German hospitals between 2010 and 2013 compared two treatment strategies instead of individual drugs. Secondary end-points were the two PSP scales as well as measures of quality of life (SF-36) and the Positive and Negative Syndrome Scale (PANSS).
RESULTS


149 patients were randomised. There was no difference between the two treatment strategies (first-generation versus second-generation antipsychotics) with regard to the PSP. There were differences in doctors' assessments regarding psychosocial functioning compared with patients' own assessments. Furthermore, there were relationships between the PSP and quality of life, level of skills (ICF), and severity of disease (PANSS), level of sexual activities and poor well-being under antipsychotic medication but not with cognitive changes.
CONCLUSIONS


The findings on psychosocial functioning of patients with schizophrenia related to severity and skill level could be confirmed. Further findings were the correlation between psychosocial functioning and quality of life, well-being under treatment, and sexuality what emphasizes the substantial importance of a reduced psychosocial functioning.",2021,There was no difference between the two treatment strategies (first-generation versus second-generation antipsychotics) with regard to the PSP.,"['patients with schizophrenia', 'Patients with Schizophrenia', '14 German hospitals between 2010 and 2013 compared two treatment strategies instead of individual drugs', '149 patients were randomised']",[],"['PSP scales as well as measures of quality of life (SF-36) and the Positive and Negative Syndrome Scale (PANSS', ""doctors' assessments regarding psychosocial functioning"", 'Personal and Social Performance (PSP', 'psychosocial functioning and quality of life', 'PSP and quality of life, level of skills (ICF), and severity of disease (PANSS), level of sexual activities and poor well-being under antipsychotic medication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C5191071', 'cui_str': '149'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",149.0,0.0268036,There was no difference between the two treatment strategies (first-generation versus second-generation antipsychotics) with regard to the PSP.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kossmann', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Heller', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brüne', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'Competence Centre for Clinical Trials - Biometry, University of Bremen, Bremen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heinze', 'Affiliation': 'Brandenburg Medical School, University Clinic for Psychiatry and Psychotherapy, Immanuel Klinik Rüdersdorf, Rüdersdorf, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cordes', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mühlbauer', 'Affiliation': 'Department of Pharmacology, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rüther', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Timm', 'Affiliation': 'Competence Centre for Clinical Trials - Biometry, University of Bremen, Bremen, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gründer', 'Affiliation': 'Department of Molecular Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Juckel', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany. georg.juckel@rub.de.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09773-y']
128,32511152,Storytelling Through Music to Improve Well-being in Oncology Nurses: A Feasibility Study.,"BACKGROUND


Professional grief is one cause of psychosocial stress that, if not attended to, may contribute to burnout and compassion fatigue. Oncology nurses often avoid their emotions and learn to cope with professional grief in isolation. Interventions aimed at professional grief are limited.
OBJECTIVES


To determine the feasibility of implementing a multidimensional intervention, Storytelling Through Music, with oncology nurses.
INTERVENTION/METHODS


This was a 2-group, quasi-experimental design utilizing both qualitative and quantitative methods. The 6-week intervention combined storytelling, reflective writing, music, and psychoeducation. Descriptive statistics and conventional content analysis were used to analyze the feasibility data.
RESULTS


Most participants (n = 43) were female, white, working full-time in the outpatient oncology setting, with an average 8.5 years (range, 2-36 years) of oncology experience. Ninety-eight percent of the intervention was completed, and 98% of participants were retained. Analysis indicates that the intervention was acceptable, the participants learned they were not alone in their feelings, and they were supported by the group.
CONCLUSIONS


Results indicate that Storytelling Through Music is a feasible and acceptable intervention to address work-related emotions and psychosocial stress in this group of oncology nurses.
IMPLICATIONS FOR PRACTICE


In 2017, the National Academy of Medicine stated clinician well-being must be a priority. Participation in this study was independently sought out by the oncology nurses and completed during their personal time. A future policy recommendation is to make participation in wellness interventions part of the mandatory competency training required by accrediting bodies so that institutions ensure the well-being of clinicians as a priority.",2021,"CONCLUSIONS


Results indicate that Storytelling Through Music is a feasible and acceptable intervention to address work-related emotions and psychosocial stress in this group of oncology nurses.
","['Oncology Nurses', 'Most participants (n = 43) were female, white, working full-time in the outpatient oncology setting, with an average 8.5 years (range, 2-36 years) of oncology experience']","['intervention combined storytelling, reflective writing, music, and psychoeducation']",[],"[{'cui': 'C0557529', 'cui_str': 'Oncology nurse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]",[],43.0,0.021103,"CONCLUSIONS


Results indicate that Storytelling Through Music is a feasible and acceptable intervention to address work-related emotions and psychosocial stress in this group of oncology nurses.
","[{'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Phillips', 'Affiliation': 'Author Affiliations: The Phyllis F. Cantor Center for Research in Nursing and Patient Care, Dana-Farber Cancer Institute, Boston, Massachusetts (Dr Phillips); and Schools of Nursing (Drs Volker and Becker) and Law (Dr Davidson), The University of Texas at Austin.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Volker', 'Affiliation': ''}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Davidson', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000836']
129,32511154,Virtual Reality Intervention Targeting Pain and Anxiety Among Pediatric Cancer Patients Undergoing Peripheral Intravenous Cannulation: A Randomized Controlled Trial.,"BACKGROUND


Peripheral intravenous cannulation (PIC) is commonly performed in cancer treatment and causes pain and anxiety to children with cancer.
OBJECTIVE


The aim of this study was to determine whether virtual reality distraction intervention can alleviate pain and anxiety and reduce length of procedure among pediatric cancer patients undergoing PIC.
METHODS


One hundred eight pediatric cancer patients aged 6 to 17 years were recruited from a regional public hospital in Hong Kong to participate in this randomized controlled trial. The intervention group received virtual reality distraction intervention, and the control group received standard care. The primary outcome was child-reported pain. Secondary outcomes included child-reported anxiety, pulse rate, and length of procedure. Outcome measurements were conducted at 5 minutes before, during, and immediately after the procedure.
RESULTS


Pediatric cancer patients in the intervention group demonstrated a significantly greater reduction in pain (estimated mean difference = -1.69, P = .007) and anxiety levels (estimated mean difference = -3.50, P < .001) compared with the control group. The mean duration (in minutes) for the PIC procedure was significantly shorter among participants receiving virtual reality intervention compared with the control counterparts (estimated mean difference = -0.75, P = .017). However, no significant difference was observed in pulse rate during and after the procedure between groups.
CONCLUSIONS


Findings indicate that virtual reality is safe and effective to alleviate pain and anxiety among pediatric cancer patients undergoing PIC procedure.
IMPLICATIONS FOR PRACTICE


Virtual reality can be considered as an adjunctive treatment to manage pain and anxiety in pediatric cancer patients before and during PIC procedure.",2021,"The mean duration (in minutes) for the PIC procedure was significantly shorter among participants receiving virtual reality intervention compared with the control counterparts (estimated mean difference = -0.75, P = .017).","['pediatric cancer patients before and during PIC procedure', 'pediatric cancer patients undergoing PIC procedure', 'pediatric cancer patients undergoing PIC', 'One hundred eight pediatric cancer patients aged 6 to 17 years were recruited from a regional public hospital in Hong Kong to participate', 'children with cancer', 'Pediatric cancer patients', 'Pediatric Cancer Patients Undergoing Peripheral Intravenous Cannulation']","['virtual reality distraction intervention, and the control group received standard care', 'Virtual Reality Intervention', 'virtual reality distraction intervention', 'Peripheral intravenous cannulation (PIC', 'virtual reality intervention']","['mean duration', 'pain and anxiety and reduce length of procedure', 'pain and anxiety', 'Pain and Anxiety', 'pulse rate', 'child-reported pain', 'pain', 'anxiety levels', 'child-reported anxiety, pulse rate, and length of procedure']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1299418', 'cui_str': 'Length of procedure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",108.0,0.142381,"The mean duration (in minutes) for the PIC procedure was significantly shorter among participants receiving virtual reality intervention compared with the control counterparts (estimated mean difference = -0.75, P = .017).","[{'ForeName': 'Cho Lee', 'Initials': 'CL', 'LastName': 'Wong', 'Affiliation': 'Author Affiliations: The Nethersole School of Nursing (Dr Wong, Prof Chan, Drs Choi and Chen, and Miss Yeung and Chan) and Department of Paediatrics (Dr Li), Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chi Kong', 'Initials': 'CK', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Carmen W H', 'Initials': 'CWH', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Man Ting', 'Initials': 'MT', 'LastName': 'Yeung', 'Affiliation': ''}, {'ForeName': 'On Na', 'Initials': 'ON', 'LastName': 'Chan', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000844']
130,32548854,S100B and NSE in Cluster Headache - Evidence for Glial Cell Activation?,"OBJECTIVE


Neuronal-specific enolase (NSE) and protein S100B have gained considerable interest as the markers of CNS injury, glial cell activation, and/or blood-brain barrier (BBB) disruption. No studies have investigated NSE and S100B in cluster headache (CH), but these biomarkers could contribute to the understanding of CH.
METHODS


Patients with episodic CH in bout (eCHa), in remission (eCHr), and chronic CH (cCH) were included in this randomized, double-blind, placebo-controlled, 2-way cross-over provocation study carried out at the Danish Headache Center. The primary endpoints included (1) differences of NSE and S100B in between groups (eCHa, eCHr, and cCH) at baseline; (2) differences over time in plasma concentrations of NSE and S100B between patient developing an attack and those who did not; (3) differences in plasma concentrations over time of NSE and S100B between active day and placebo day. Baseline findings were compared to the historical data on migraine patients and healthy controls and presented with means ± SD.
RESULTS


Nine eCHa, 9 eCHr, and 13 cCH patients completed the study and blood samples from 11 CGRP-induced CH attacks were obtained. There were no differences in NSE levels between CH groups at baseline, but CH patients in active disease phase had higher levels compared with 32 migraine patients (9.1 ± 2.2 µg/L vs 6.0 ± 2.2 µg/L, P < .0001) and 6 healthy controls (9.1 ± 2.2 µg/L vs 7.3 ± 2.0 µg/L, P = .007). CGRP-infusion caused no NSE changes and, but a slight, non-significant, increase in NSE was seen in patients who reported a CGRP-induced CH attack (2.39 µg/L, 95% Cl [-0.26, 3.85], P = .061). At baseline S100B levels in eCHa patients were higher compared to cCH patients (0.06 ± 0.02 µg/L vs 0.04 ± 0.02 µg/L, P = .018). Infusion of CGRP and CGRP-induced attacks did not change S100B levels. Apart from induced CH-attacks no other adverse events were noted.
CONCLUSIONS


At baseline eCHa patients had higher S100B plasma levels than cCH patients and there was a slight, however not significant, NSE increase in response to CGRP-induced CH attack. Our findings suggest a possible role of an ictal activation of glial cells in CH pathophysiology, but further studies are warranted.",2020,"CGRP-infusion caused no NSE changes and, but a slight, non-significant, increase in NSE was seen in patients who reported a CGRP-induced CH attack (2.39 µg/L, 95% Cl","['Patients with episodic CH in bout (eCHa), in remission (eCHr), and chronic CH (cCH', 'Nine eCHa, 9 eCHr, and 13 cCH patients']","['CGRP and CGRP', 'CGRP-infusion', 'placebo']","['S100B plasma levels', 'NSE', 'CH attack', 'adverse events', 'NSE and S100B in between groups (eCHa, eCHr, and cCH) at baseline', 'NSE levels', 'plasma concentrations of NSE and S100B', 'plasma concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393739', 'cui_str': 'Episodic cluster headache'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031691', 'cui_str': 'Enolase'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.116189,"CGRP-infusion caused no NSE changes and, but a slight, non-significant, increase in NSE was seen in patients who reported a CGRP-induced CH attack (2.39 µg/L, 95% Cl","[{'ForeName': 'Agneta H', 'Initials': 'AH', 'LastName': 'Snoer', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Luise H', 'Initials': 'ALH', 'LastName': 'Vollesen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus Paulin', 'Initials': 'RP', 'LastName': 'Beske', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoffmann', 'Affiliation': ""Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Niklas R', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Martinussen', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rigmor H', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Headache,['10.1111/head.13864']
131,32530869,"The Effect of Foot Reflexology Applied Before Coronary Angiography and Percutaneous Transluminal Coronary Angioplasty on Anxiety, Stress, and Cortisol Levels of Individuals: A Randomized Controlled Trial.","BACKGROUND


Coronary angiography and percutaneous transluminal coronary angioplasty procedures cause anxiety and stress in individuals.
OBJECTIVE


The aim of this study was to determine the effect of foot reflexology applied before coronary angiography and percutaneous transluminal coronary angioplasty on the anxiety, stress, and cortisol levels of individuals.
METHODS


A simple randomized trial design was used. The patients who met the inclusion criteria were divided into 4 groups including experimental and control groups of coronary angiography patients (30 patients in each group) and percutaneous transluminal coronary angioplasty (26 patients in each group) by randomization method. Data were collected with the State-Trait Anxiety Inventory and Distress Thermometer 90 minutes before coronary angiography and percutaneous transluminal coronary angioplasty and the laboratory samples were taken. After these procedures, foot reflexology was applied to both feet of the patients in the experimental group for 30 minutes, and the control group received only standard care. The inventories were reapplied 30 minutes after the reflexology application and after coronary angiography and percutaneous transluminal coronary angioplasty.
RESULTS


Whereas there was no statistically significant difference (P > .05) between the coronary angiography and percutaneous transluminal coronary angioplasty experimental and control groups in Anxiety Inventory and stress median scores before reflexology, a significant difference was found (P < .001) 30 minutes after reflexology application and after coronary angiography and percutaneous transluminal coronary angioplasty. After the reflexology, anxiety and stress scores were significantly lower in the experimental group compared with the control group (P < .001). Whereas there was a significant difference (P < .001) in the within-group cortisol values of both reflexology groups, no significant difference was found in the control groups (P > .05).
CONCLUSIONS


The application of reflexology before coronary angiography and percutaneous transluminal coronary angioplasty reduces the levels of anxiety, stress, and cortisol without any side effects.",2021,"Whereas there was no statistically significant difference (P > .05) between the coronary angiography and percutaneous transluminal coronary angioplasty experimental and control groups in Anxiety Inventory and stress median scores before reflexology, a significant difference was found (P < .001)","['individuals', 'Individuals']","['Coronary angiography and percutaneous transluminal coronary angioplasty procedures', 'coronary angiography patients', 'control group received only standard care', 'percutaneous transluminal coronary angioplasty', 'Foot Reflexology Applied Before Coronary Angiography and Percutaneous Transluminal Coronary Angioplasty', 'foot reflexology applied before coronary angiography and percutaneous transluminal coronary angioplasty', 'coronary angiography and percutaneous transluminal coronary angioplasty']","['levels of anxiety, stress, and cortisol without any side effects', 'Anxiety Inventory and stress median scores', 'anxiety, stress, and cortisol levels', 'Anxiety, Stress, and Cortisol Levels', 'anxiety and stress scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C2936173', 'cui_str': 'Percutaneous transluminal coronary angioplasty'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",,0.017879,"Whereas there was no statistically significant difference (P > .05) between the coronary angiography and percutaneous transluminal coronary angioplasty experimental and control groups in Anxiety Inventory and stress median scores before reflexology, a significant difference was found (P < .001)","[{'ForeName': 'Birgül', 'Initials': 'B', 'LastName': 'Vural Doğru', 'Affiliation': ''}, {'ForeName': 'Fisun', 'Initials': 'F', 'LastName': 'ŞenuzunAykar', 'Affiliation': ''}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Yıldırım', 'Affiliation': ''}, {'ForeName': 'Oğuz', 'Initials': 'O', 'LastName': 'Yavuzgil', 'Affiliation': ''}, {'ForeName': 'Eser', 'Initials': 'E', 'LastName': 'Sözmen', 'Affiliation': ''}, {'ForeName': 'Hikmet', 'Initials': 'H', 'LastName': 'Memmedov', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000700']
132,32524360,Impact of a Preoperative Video-Based Educational Intervention on Postoperative Outcomes in Elective Major Abdominal Surgery: a Randomized Controlled Trial.,,2020,,['Elective Major Abdominal Surgery'],['Preoperative Video-Based Educational Intervention'],['Postoperative Outcomes'],"[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.142779,,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Campagna', 'Affiliation': 'Department of Public Health and Pediatrics, University of Torino, via Santena 5 bis, 10126, Torino, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Clari', 'Affiliation': 'Department of Public Health and Pediatrics, University of Torino, via Santena 5 bis, 10126, Torino, Italy. marco.clari@unito.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Delfino', 'Affiliation': 'Department of Public Health and Pediatrics, University of Torino, via Santena 5 bis, 10126, Torino, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Rolfo', 'Affiliation': 'Ordine Mauriziano Hospital, via Magellano 1, 10128, Torino, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Rizzo', 'Affiliation': 'Ordine Mauriziano Hospital, via Magellano 1, 10128, Torino, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Berchialla', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Torino, via Santena 5 bis, 10126, Torino, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Ferrero', 'Affiliation': 'Ordine Mauriziano Hospital, via Magellano 1, 10128, Torino, Italy.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-020-04667-7']
133,32521115,Randomised comparison of techniques for control of the dorsal venous complex during robot-assisted laparoscopic radical prostatectomy.,"OBJECTIVE


To prospectively compare the effects of endoscopic stapling, division and suture ligation, and suture ligation with suspension of the dorsal venous complex (DVC) on continence during robot-assisted laparoscopic radical prostatectomy (RARP).
PATIENTS AND METHODS


In all, 300 consecutive patients undergoing RARP by a single surgeon were randomised to three groups: endoscopic stapling, cut and suture ligation, and suture ligation with suspension. The only difference between the groups was the technique to control the DVC. Pad-free continence (PFC) and overall continence (0 pads/day with or without security pad) were assessed with patient reported pad usage records and validated questionnaires (Expanded Prostate Cancer Index) at 3, 12, and 15 months. Secondary endpoints were erectile function (EF) recovery (defined as erections sufficient for sexual activity) and the rate of apical surgical margins. Univariate and multivariate analyses were conducted to determine predictors for recovery of both urinary continence and EF.
RESULTS


The three groups were comparable in terms of age, body mass index, prostate size, American Urological Association symptom score, Sexual Health Inventory for Men, and clinical stage. There were no differences found in terms of operative times, estimated blood loss, pathological stage, and positive apical margin. There was no difference between the three groups with regard to overall continence or PFC at 3 months. However, overall continence at 15 months for ligation and suspension was 99% and was superior to stapler (88%) (P = 0.002) and cut and suture ligation (88%) (P = 0.002). Additionally, PFC at 15 months was superior for ligation and suspension (87%) as compared to stapler (73%) and cut and suture ligation (75%) (P = 0.045). The technique of DVC control did not impact EF. Men with nerve sparing had better continence compared to no nerve sparing at 3 months (62% vs 42%, P = 0.045), but not at 15 months. The median time to continence was 2 months for patients receiving nerve sparing compared to 4.5 months for non-nerve sparing (P = 0.02).
CONCLUSION


Suture suspension of the DVC during RARP contributes to higher overall continence rates compared to stapling and cut and suture. Nerve sparing contributes to earlier return of continence than non-nerve sparing.",2020,There was no difference between the three groups with regard to overall continence or pad-fee continence at 3 months.,[' 300 consecutive patients undergoing RARP by a single surgeon'],"['endoscopic stapling, division and suture ligation, and suture ligation with suspension of the dorsal venous complex (DVC', 'Robotic-assisted Laparoscopic Radical Prostatectomy', 'endoscopic stapling, cut and suture ligation, and suture ligation with suspension']","['overall continence or pad-fee continence', 'operative times, EBL, pathological stage, and positive apical margin', 'Median time to continence', 'age, BMI, prostate size, AUA symptom score, SHIM, and clinical stage', 'overall continence', 'overall continence rates', 'Pad-free continence (PFC) and overall continence', 'erectile function recovery (defined as erections sufficient for sexual activity) and the rate of apical surgical margins', 'pad-free continence']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0185012', 'cui_str': 'Closure by staple'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0185016', 'cui_str': 'Suture ligation'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0426731', 'cui_str': 'Prostate size'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0142223', 'cui_str': 'SHIMS'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0229985', 'cui_str': 'Surgical margins'}]",300.0,0.0246818,There was no difference between the three groups with regard to overall continence or pad-fee continence at 3 months.,"[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Department of Urology, Swedish Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Heulitt', 'Affiliation': 'Department of Urology, Swedish Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Janet J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Swedish Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liao', 'Affiliation': 'Department of Urology, Swedish Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Hsin-Fang', 'Initials': 'HF', 'LastName': 'Li', 'Affiliation': 'Medical Data Research Center (MDRC), Providence St. Vincent Medical Center, Portland, OR, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Porter', 'Affiliation': 'Department of Urology, Swedish Medical Center, Seattle, WA, USA.'}]",BJU international,['10.1111/bju.15133']
134,32546554,A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in high-grade uterine sarcoma after stabilization or response to doxorubicin ± ifosfamide following surgery or in metastatic first line treatment (EORTC62113).,"BACKGROUND


Uterine sarcomas are a group of rare tumors that include different subtypes. Patients with histopathological high-grade diseases are at high-risk of recurrence or progression, and have a poor prognosis. We aim to explore the most appropriate management in patients with uterine high-grade sarcomas.
PRIMARY OBJECTIVE


To assess the efficacy of maintenance treatment with cabozantinib in patients with high-grade uterine sarcomas who achieved clinical benefit after standard chemotherapy.
STUDY HYPOTHESIS


Maintenance treatment with cabozantinib after standard chemotherapy given as an adjuvant treatment after curative surgery, or in locally advanced or metastatic disease, increases progression-free survival compared with placebo TRIAL DESIGN: This is a randomized double blinded phase II trial.
MAJOR INCLUSION/EXCLUSION CRITERIA


The study is enrolling adult patients with high-grade undifferentiated uterine sarcomas, high-grade endometrial stromal sarcomas, high-grade leiomyosarcoma, and high-grade adenosarcoma, FIGO (Federation International gynecologue Obstétricien) stage II/III to IV in stable disease or who achieved complete or partial response with doxorubicin ± ifosfamide, who are assigned 1:1 to 60 mg daily cabozantinib (experimental arm) or placebo (control arm), as maintenance therapy. Exclusion criteria include low-grade sarcoma.
PRIMARY ENDPOINT


Progression-free survival at 4 months.
SAMPLE SIZE


The study plans to enroll 90 patients to allow the randomization of 54 patients to detect an improvement in 4-month progression-free survival from 50% to 80% with 15% significance level and 85% power. Estimated dates for accrual completion: recruitment for the trial started in February 2015, and has currently enrolled 83 patients, of whom 35 patients have been randomized. The end of recruitment is anticipated for December 2020.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov, number NCT01979393.",2020,"Patients with histopathological high-grade diseases are at high-risk of recurrence or progression, and have a poor prognosis.","['patients with uterine high-grade sarcomas', 'enrolling adult patients with high-grade undifferentiated uterine sarcomas, high-grade endometrial stromal sarcomas, high-grade leiomyosarcoma, and high-grade adenosarcoma, FIGO (Federation International gynecologue Obstétricien) stage II/III to IV in stable disease or who achieved complete or partial response with', '83 patients, of whom 35 patients have been randomized', 'Patients with histopathological high-grade diseases', 'patients with high-grade uterine sarcomas who achieved clinical benefit after standard chemotherapy']","['cabozantinib after standard chemotherapy', 'cabozantinib (experimental arm) or placebo', 'cabozantinib', 'doxorubicin ± ifosfamide']","['Progression-free survival at 4 months', '4-month progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2239246', 'cui_str': 'Endometrial stromal sarcoma, high grade'}, {'cui': 'C0023269', 'cui_str': 'Leiomyosarcoma'}, {'cui': 'C0001442', 'cui_str': 'Adenosarcoma'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0338113', 'cui_str': 'Sarcoma of uterus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",83.0,0.477096,"Patients with histopathological high-grade diseases are at high-risk of recurrence or progression, and have a poor prognosis.","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Centre Leon Berard, Lyon, Rhône-Alpes, France isabelle.ray-coquard@lyon.unicancer.fr.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hatcher', 'Affiliation': 'medical oncology, Cambridge University, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Bompas', 'Affiliation': 'Medical Oncology Department, ICO, Saint Herblain, Pays de la Loire, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Casado', 'Affiliation': 'Medical Oncology Department, Complutense University of Madrid, Madrid, Comunidad de Madrid, Spain.'}, {'ForeName': 'Annekke', 'Initials': 'A', 'LastName': 'Westermann', 'Affiliation': 'Medical Oncology Department, Academisch Medisch Centrum, Amsterdam, North Holland, The Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Isambert', 'Affiliation': 'Medical Oncology Department, Centre Georges-François Leclerc, Dijon, Bourgogne-Franche-Comté, France.'}, {'ForeName': 'Paolo Giovanni', 'Initials': 'PG', 'LastName': 'Casali', 'Affiliation': 'Medical Oncology Department, IRCCS, Milano, Lombardia, Italy.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pratap', 'Affiliation': 'Medical Oncology Department, Oxford University, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stark', 'Affiliation': 'Medical Oncology Department, Leeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Valverde', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron Hospital, Barcelona, Catalunya, Spain.""}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Medical Oncology Department, Nottingham Trent University, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Huizing', 'Affiliation': 'Medical Oncology Department, Universitair Ziekenhuis Antwerpen, Edegem, Antwerp, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Floquet', 'Affiliation': 'Medical Oncology Department, Institut Bergonié, Bordeaux, Aquitaine, France.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lindner', 'Affiliation': 'Medical Oncology Department, Ludwig-Maximilians-Universitat Munchen, Munchen, Bayern, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'Medical Oncology Department, Eberhard Karls Universitat Tubingen, Tubingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Seddon', 'Affiliation': 'Medical Oncology Department, University College London, London, London, UK.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': 'Statistics and Quality of Life, EORTC, Brussels, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Medical Oncology, Royal Marsden Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Reed', 'Affiliation': 'Medical Oncology, NHS Greater Glasgow and Clyde, Glasgow, Glasgow, UK.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001519']
135,32523035,Who's a good boy? Effects of dog and owner body weight on veterinarian perceptions and treatment recommendations.,"BACKGROUND


Weight bias against persons with obesity impairs health care delivery and utilization and contributes to poorer health outcomes. Despite rising rates of pet obesity (including among dogs), the potential for weight bias in veterinary settings has not been examined.
SUBJECTS/METHODS


In two online, 2 × 2 experimental studies, the effects of dog and owner body weight on perceptions and treatment recommendations were investigated in 205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2). In both studies, participants were randomly assigned to view one of four vignettes of a dog and owners with varying weight statuses (lean vs. obesity). Dependent measures included emotion/liking ratings toward the dog and owners; perceived causes of the dog's weight; and treatment recommendations and compliance expectations. Other clinical practices, such as terms to describe excess weight in dogs, were also assessed.
RESULTS


Veterinarians and students both reported feeling more blame, frustration, and disgust toward dogs with obesity and their owners than toward lean dogs and their owners (p values < 0.001). Interactions between dog and owner body weight emerged for perceived causes of obesity, such that owners with obesity were perceived as causing the dog with obesity's weight, while lean owners were perceived as causing the lean dog's weight. Participants were pessimistic about treatment compliance from owners of the dog with obesity, and weight loss treatment was recommended for the dog with obesity when presenting with a medical condition ambiguous in its relationship to weight. Veterinarians and students also reported use of stigmatizing terms to describe excess weight in dogs.
CONCLUSIONS


Findings from this investigation, with replication, have implications for training and practice guidelines in veterinary medicine.",2020,"In two online, 2 × 2 experimental studies, the effects of dog and owner body weight on perceptions and treatment recommendations were investigated in 205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2).",['205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2'],[],"[""emotion/liking ratings toward the dog and owners; perceived causes of the dog's weight; and treatment recommendations and compliance expectations""]","[{'cui': 'C0242856', 'cui_str': 'Veterinarian'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",205.0,0.0204946,"In two online, 2 × 2 experimental studies, the effects of dog and owner body weight on perceptions and treatment recommendations were investigated in 205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2).","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Pearl', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. rpearl@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bach', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Leonard', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Michel', 'Affiliation': 'Department of Clinical Sciences and Advanced Medicine, University of Pennsylvania School of Veterinary Medicine, Philadelphia, PA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-020-0622-7']
136,32469183,Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer.,"BACKGROUND


Injectable luteinizing hormone-releasing hormone agonists (e.g., leuprolide) are the standard agents for achieving androgen deprivation for prostate cancer despite the initial testosterone surge and delay in therapeutic effect. The efficacy and safety of relugolix, an oral gonadotropin-releasing hormone antagonist, as compared with those of leuprolide are not known.
METHODS


In this phase 3 trial, we randomly assigned patients with advanced prostate cancer, in a 2:1 ratio, to receive relugolix (120 mg orally once daily) or leuprolide (injections every 3 months) for 48 weeks. The primary end point was sustained testosterone suppression to castrate levels (<50 ng per deciliter) through 48 weeks. Secondary end points included noninferiority with respect to the primary end point, castrate levels of testosterone on day 4, and profound castrate levels (<20 ng per deciliter) on day 15. Testosterone recovery was evaluated in a subgroup of patients.
RESULTS


A total of 622 patients received relugolix and 308 received leuprolide. Of men who received relugolix, 96.7% (95% confidence interval [CI], 94.9 to 97.9) maintained castration through 48 weeks, as compared with 88.8% (95% CI, 84.6 to 91.8) of men receiving leuprolide. The difference of 7.9 percentage points (95% CI, 4.1 to 11.8) showed noninferiority and superiority of relugolix (P<0.001 for superiority). All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001). The percentage of patients with castrate levels of testosterone on day 4 was 56.0% with relugolix and 0% with leuprolide. In the subgroup of 184 patients followed for testosterone recovery, the mean testosterone levels 90 days after treatment discontinuation were 288.4 ng per deciliter in the relugolix group and 58.6 ng per deciliter in the leuprolide group. Among all the patients, the incidence of major adverse cardiovascular events was 2.9% in the relugolix group and 6.2% in the leuprolide group (hazard ratio, 0.46; 95% CI, 0.24 to 0.88).
CONCLUSIONS


In this trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that with leuprolide, with a 54% lower risk of major adverse cardiovascular events. (Funded by Myovant Sciences; HERO ClinicalTrials.gov number, NCT03085095.).",2020,All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001).,"['Advanced Prostate Cancer', 'men with advanced prostate cancer', '622 patients received relugolix and 308 received', 'patients with advanced prostate cancer']","['luteinizing hormone-releasing hormone agonists (e.g., leuprolide', 'Oral Relugolix', 'leuprolide', 'relugolix']","['castrate levels of testosterone on day 4, and profound castrate levels', 'Testosterone recovery', 'sustained testosterone suppression to castrate levels', 'mean testosterone levels', 'incidence of major adverse cardiovascular events', 'castrate levels of testosterone', 'superiority of relugolix over leuprolide', 'noninferiority and superiority of relugolix']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}]",622.0,0.384751,All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001).,"[{'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Cookson', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Saltzstein', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Tutrone', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Akaza', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bossi', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'van Veenhuyzen', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Selby', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Kang', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Walling', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004325']
137,32564141,Ultrastructural changes of smooth and rough titanium implant surfaces induced by metal and plastic periodontal probes.,"OBJECTIVES


To determine the ultrastructural changes of titanium surfaces of dental implants induced by the tip of periodontal probes.
MATERIALS AND METHODS


A total of 40 samples of smooth and rough surfaces of titanium implants were randomly assigned for the treatment with metal or plastic periodontal probes under application angles of 20° and 60°. Titanium surfaces have been evaluated with CLSM prior and following to experimental probing determining various standardized 2D and 3D roughness parameters.
RESULTS


The average profile and surface roughness (Ra and Sa) showed no significant difference between treated and untreated samples on smooth and rough surface areas irrespective of the probe material. On smooth surfaces several amplitude roughness parameters were increased with metal probes but reached significance only for Rp (p = 0.007). Rough surface parts showed a slight but not significant reduction of roughness following to the contact with metal probes. The surface roughness remained almost unchanged on smooth and rough implant surfaces using plastic probes. The surface roughness on implant surfaces was not dependent on the application angle irrespective of the probe material.
CONCLUSION


Probing of titanium implants with metal probes and even less with plastic probes causes only minor changes of the surface roughness. The clinical significance of these changes remains to be elucidated.
CLINICAL RELEVANCE


Using plastic probes for the clinical evaluation of the peri-implant sulcus might avoid ultrastructural changes to titanium implant surfaces.",2021,The average profile and surface roughness (Ra and Sa) showed no significant difference between treated and untreated samples on smooth and rough surface areas irrespective of the probe material.,['A total of 40 samples of smooth and rough surfaces of titanium implants'],[],"['ultrastructural changes of titanium surfaces', 'average profile and surface roughness (Ra and Sa', 'surface roughness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",,0.0235481,The average profile and surface roughness (Ra and Sa) showed no significant difference between treated and untreated samples on smooth and rough surface areas irrespective of the probe material.,"[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Folwaczny', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, D-80336, Munich, Germany. mfolwa@dent.med.uni-muenchen.de.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Rudolf', 'Affiliation': 'ZEISS Microscopy Customer Center Europe, Carl Zeiss Microscopy GmbH, Oberkochen, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Frasheri', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, D-80336, Munich, Germany.'}, {'ForeName': 'Madlena', 'Initials': 'M', 'LastName': 'Betthäuser', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, D-80336, Munich, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03341-1']
138,32444264,Effect of Pharmacologic Prophylaxis on Venous Thromboembolism After Radical Prostatectomy: The PREVENTER Randomized Clinical Trial.,"BACKGROUND


Direct high-quality evidence is lacking evaluating perioperative pharmacologic prophylaxis (PP) after radical prostatectomy (RP) to prevent venous thromboembolism (VTE) leading to significant practice variation.
OBJECTIVE


To study the impact of in-hospital PP on symptomatic VTE incidence and adverse events after RP at 30 d, with the secondary objective of evaluating overall VTE in a screening subcohort.
DESIGN, SETTING, AND PARTICIPANTS


A prospective, phase 4, single-center, randomized trial of men with prostate cancer undergoing open or robotic-assisted laparoscopic RP was conducted (July 2017-November 2018).
INTERVENTION


PP (subcutaneous heparin) plus routine care versus routine care alone. The screening subcohort was offered lower extremity duplex ultrasound at 30 d.
OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS


The primary efficacy outcome was symptomatic VTE incidence (pulmonary embolism [PE] or deep venous thrombosis [DVT]). Primary safety outcomes included the incidence of symptomatic lymphocele, hematoma, or bleeding after surgery. Secondary outcomes were overall VTE, estimated blood loss, total surgical drain output, complications, and surveillance imaging bias. Fisher's exact test and modified Poisson regression were performed.
RESULTS AND LIMITATIONS


A total of 501 patients (75% robotic) were randomized and >99% (500/501) completed follow-up. At second interim analysis (N = 445), the symptomatic VTE rate was 2.3% (four PE + DVT and one DVT) for routine care versus 0.9% (one PE + DVT and one DVT) for PP (relative risk 0.40 [95% confidence interval 0.08-2.03], p = 0.3) meeting a futility threshold for early stopping. In the screening subcohort, the overall VTE rate was 3.3% versus 2.4% (p = 0.7). Results were similar at the final analysis (symptomatic VTE: 2.0% vs 0.8%, p = 0.3; overall VTE: 2.9% vs 2.8%, p = 1). No differences were observed in safety or secondary outcomes. All VTE events (seven symptomatic and three asymptomatic) occurred in patients undergoing pelvic lymph node dissection.
CONCLUSIONS


This study was not able to demonstrate a statistically significant reduction in symptomatic VTE associated with PP. There was no increase in the development of symptomatic lymphoceles, bleeding, or other adverse events. Given that the event rate was lower than powered for, further research is needed among high-risk patients (Caprini score ≥8) or patients receiving pelvic lymph node dissection.
PATIENT SUMMARY


In this report, we randomized patients undergoing radical prostatectomy to perioperative pharmacologic prophylaxis or routine care alone. We found that pharmacologic prophylaxis did not reduce postoperative symptomatic venous thromboembolism significantly for men at routine risk. Importantly, pharmacologic prophylaxis did not increase adverse events, such as formation of lymphoceles or bleeding, and can safely be implemented when indicated for patients with risk factors undergoing radical prostatectomy.",2020,"Importantly, pharmacologic prophylaxis did not increase adverse events, such as formation of lymphoceles or bleeding, and can safely be implemented when indicated for patients with risk factors undergoing radical prostatectomy.","['men with prostate cancer undergoing open or', 'patients undergoing', 'patients with risk factors undergoing radical prostatectomy', '501 patients (75% robotic']","['Radical Prostatectomy', 'robotic-assisted laparoscopic RP', 'radical prostatectomy (RP', 'Pharmacologic Prophylaxis', 'radical prostatectomy to perioperative pharmacologic prophylaxis or routine care alone', 'PP (subcutaneous heparin) plus routine care versus routine care alone']","['overall VTE rate', 'symptomatic VTE rate', 'incidence of symptomatic lymphocele, hematoma, or bleeding after surgery', 'postoperative symptomatic venous thromboembolism', 'development of symptomatic lymphoceles, bleeding, or other adverse events', 'adverse events', 'symptomatic VTE incidence (pulmonary embolism [PE] or deep venous thrombosis [DVT', 'formation of lymphoceles or bleeding', 'Venous Thromboembolism', 'overall VTE, estimated blood loss, total surgical drain output, complications, and surveillance imaging bias']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2607832', 'cui_str': 'Surgical drain'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",501.0,0.14869,"Importantly, pharmacologic prophylaxis did not increase adverse events, such as formation of lymphoceles or bleeding, and can safely be implemented when indicated for patients with risk factors undergoing radical prostatectomy.","[{'ForeName': 'Hiten D', 'Initials': 'HD', 'LastName': 'Patel', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: hitenpatel@jhmi.edu.'}, {'ForeName': 'Farzana A', 'Initials': 'FA', 'LastName': 'Faisal', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Joice', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Zeyad R', 'Initials': 'ZR', 'LastName': 'Schwen', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phillip M', 'Initials': 'PM', 'LastName': 'Pierorazio', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Johnson', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Trinity J', 'Initials': 'TJ', 'LastName': 'Bivalacqua', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Misop', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gorin', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'H Ballentine', 'Initials': 'HB', 'LastName': 'Carter', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Partin', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Pavlovich', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mohamad E', 'Initials': 'ME', 'LastName': 'Allaf', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",European urology,['10.1016/j.eururo.2020.05.001']
139,32556113,"A Phase 3, Randomized, Open-label, Noninferiority Trial Evaluating Anti-Rabies Monoclonal Antibody Cocktail (TwinrabTM) Against Human Rabies Immunoglobulin (HRIG).","BACKGROUND


Limited supply, cost and potential for severe adverse effects observed with the blood derived rabies immunoglobulin products has led to search for alternative therapies. This issue has been addressed by developing an anti-rabies monoclonal antibody cocktail.
METHODS


This is a phase 3, randomized, open-label, noninferiority trial conducted in patients with World Health Organization (WHO) category III exposure with suspected rabid animal. Eligible patients were assigned to either the test arm, TwinrabTM (docaravimab and miromavimab) or the reference arm, human rabies immunoglobulin (HRIG; Imogam® Rabies-HT), in a ratio of 1:1. The primary endpoint was the comparison of responder rates between the 2 arms assessed as percentage of those with rabies virus neutralizing antibodies titers ≥0.5 IU/mL on day 14.
RESULTS


A total of 308 patients were equally randomized into the 2 arms. In the per-protocol (PP) population, there were 90.21% responders in the TwinrabTM arm and 94.37% in the HRIG arm. The geometric mean of rapid fluorescent foci inhibition test titers in the PP on day 14 were 4.38 and 4.85 IU/mL, for the TwinrabTM and HRIG arms, respectively. There were no deaths or serious adverse events reported.
CONCLUSIONS


This study confirmed that TwinrabTM is noninferior to HRIG in terms of providing an unbroken window of protection up to day 84. This trial in healthy adults with WHO category III exposure from suspected rabid animal also establishes the safety of TwinrabTM in patients with 1 WHO approved vaccine regimen (Essen).
CLINICAL TRIALS REGISTRATION


CTRI/2017/07/009038.",2021,"There were no deaths or serious adverse events reported.
","['patients with WHO category III exposure with suspected rabid animal', 'A total of 308 patients', 'patients with one WHO approved vaccine regimen (Essen', 'healthy adults with WHO category III exposure from suspected rabid animal']","['TwinrabTM', 'Anti-Rabies Monoclonal Antibody Cocktail (TwinrabTM', 'Against Human Rabies Immunoglobulin (HRIG', 'TwinrabTM (docaravimab and miromavimab) or the reference arm, Human rabies immunoglobulin (HRIG; Imogam® Rabies-HT']","['deaths or serious adverse events', 'Geometric Mean of RFFIT titres', 'comparison of responder rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C1321098', 'cui_str': 'Human rabies'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4026551', 'cui_str': 'Imogam'}, {'cui': 'C0034494', 'cui_str': 'Rabies'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",308.0,0.167448,"There were no deaths or serious adverse events reported.
","[{'ForeName': 'Kevinkumar', 'Initials': 'K', 'LastName': 'Kansagra', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Deven', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Zydus Discovery DMCC, Dubai, UAE.'}, {'ForeName': 'Sanjeev Kumar', 'Initials': 'SK', 'LastName': 'Mendiratta', 'Affiliation': 'Biologics R&D and Mfg, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Shuchi', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Parihar', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Bhoge', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Harilal', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Drug Metabolism and Pharmacokinetic, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kalita', 'Affiliation': 'Biotechnology, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Munshi', 'Affiliation': 'TN Medical College and BYL Nair Charitable Hospital, Mumbai, India.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Kurmi', 'Affiliation': 'Shivam Hospital, Ahmedabad, India.'}, {'ForeName': 'Ruchir', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Medistar Hospital, Himmatnagar, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Subharti Medical College, Meerut, India.'}, {'ForeName': 'HiraLal', 'Initials': 'H', 'LastName': 'Bhalla', 'Affiliation': 'Subharti Medical College, Meerut, India.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Bekkalele', 'Affiliation': 'Mandya Institute of Medical Science, Mandya.'}, {'ForeName': 'RajendraKumar', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': 'GSVM Medical College, Kanpur, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Agarwal', 'Affiliation': 'Marwari Hospital and Research Centre, Guwahati, India.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'SMS Medical College, Jaipur, India.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Gawande', 'Affiliation': 'Government Medical College, Nagpur, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Chhaya', 'Affiliation': 'Saviour Hospital, Ahmedabad, India.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa779']
140,32445004,Effect of Information-Motivation-Behavioral Model Based on Protection Motivation Theory on the Psychological Resilience and Quality of Life of Patients with Type 2 DM.,"Diabetes mellitus (DM) is one of the remarkable disease challenges in the twenty-first century and poses threat to patients' physical health. Given the difficulty of treatment and the high possibility of relapse, patients often have mental illness. A total of 117 patients with type 2 DM were randomly divided into two groups for a 2-month intervention. The intervention group underwent an Information-Motivation-Behavioral skills (IMB) intervention program based on protection motivation theory, and traditional intervention was applied to the control group. No significant difference is found between the intervention and control groups before the intervention (P > 0.05). However, after the intervention, the blood glucose level and depression score of the intervention group are lower than those of the control group (P < 0.05), and the psychological resilience and quality of life are significantly higher than those of the control group (P < 0.05). The blood glucose level and depression score of the intervention group decrease after the intervention (P < 0.05), and the psychological resilience and quality of life are significantly increase (P < 0.05). No significant difference is found in the blood glucose level, depression, psychological resilience, and quality of life of the control group before and after the intervention (P > 0.05). The combination of IMB intervention and protection motivation theory is important to improving the psychological resilience of patients with type 2 DM, raising their quality of life and reducing their blood glucose level.",2021,"No significant difference is found in the blood glucose level, depression, psychological resilience, and quality of life of the control group before and after the intervention (P > 0.05).","['117 patients with type 2 DM', 'Patients with Type 2 DM', 'Diabetes mellitus (DM']","['IMB intervention and protection motivation theory', 'Information-Motivation-Behavioral skills (IMB) intervention program based on protection motivation theory, and traditional intervention', 'Information-Motivation-Behavioral Model']","['psychological resilience and quality of life', 'Psychological Resilience and Quality of Life', 'blood glucose level and depression score', 'blood glucose level, depression, psychological resilience, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",117.0,0.0135115,"No significant difference is found in the blood glucose level, depression, psychological resilience, and quality of life of the control group before and after the intervention (P > 0.05).","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': ""Endoscopy Center, The Xiang'an Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, 361101, Fujian, China.""}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, The Xiang'an Hospital of Xiamen University, School of Medicine, Xiamen University, No. 2000, Xiang'an East Road, Xiang'an District, Xiamen, 361101, China. zhangll0592@163.com.""}, {'ForeName': 'Jiwei', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ""Nursing Department, The Xiang'an Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, 361101, Fujian, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopaedics, The 1st Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09783-w']
141,32564996,A heart failure themed escape room approach to enhance pharmacy student learning.,"INTRODUCTION


The purpose of this study was to design, pilot, and evaluate the efficacy of an educational escape room to enhance second professional year doctor of pharmacy students' knowledge of heart failure medicinal chemistry, pharmacology, and therapeutics in an integrated Modular Organ Systems Therapeutics (MOST) course and to assess students' perceptions of the game.
METHODS


Heart failure pharmacology, medicinal chemistry, and pharmacotherapeutics were taught in MOST prior to the escape room activity. Students were randomized into groups of approximately eight. At the completion of the activity, students were asked to fill out a perceptions survey. A follow up survey of their perceptions was again administered four weeks after the activity.
RESULTS


One-hundred-ninety-three students participated in the escape room activity. Overall, performance indicated that the escape room satisfactorily reinforced students' learning of the course material. Students expressed satisfaction toward the escape room activity on both surveys, with response rates of 92.22% and 56.99% for the initial and follow up surveys, respectively. Findings revealed no statistically significant differences between the first and the second group of responses, confirming that positive attitudes toward the activity did not alter over time. Students' satisfaction levels were inversely related to their grade point average (r = -0.20, p = 0.05).
CONCLUSIONS


Positive student perceptions reported immediately after the completion of the escape room activity and measured in the follow-up survey demonstrated that the escape room is a satisfying learning activity that can engage all students.",2020,"Students' satisfaction levels were inversely related to their grade point average (r = -0.20, p = 0.05).
","[""students' perceptions of the game"", 'One-hundred-ninety-three students participated in the escape room activity']",[],"[""Students' satisfaction levels""]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",193.0,0.0124084,"Students' satisfaction levels were inversely related to their grade point average (r = -0.20, p = 0.05).
","[{'ForeName': 'Roda', 'Initials': 'R', 'LastName': 'Plakogiannis', 'Affiliation': 'Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, 1 University Plaza, Brooklyn, NY 11201, United States. Electronic address: roda.plakogiannis@liu.edu.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Stefanidis', 'Affiliation': ""Department of Management, Peter J. Tobin College of Business, St. John's University, 101 Astor Place, New York, NY 10003, United States. Electronic address: stefania@stjohns.edu.""}, {'ForeName': 'Nubriel', 'Initials': 'N', 'LastName': 'Hernandez', 'Affiliation': 'State University of New York (SUNY) Downstate Medical Center, 450 Clarkson Ave., Brooklyn, NY 11203, United States. Electronic address: nubriel.hernandez@downstate.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nogid', 'Affiliation': 'Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, 1 University Plaza, Brooklyn, NY 11201, United States. Electronic address: anna.nogid@liu.edu.'}]",Currents in pharmacy teaching & learning,['10.1016/j.cptl.2020.04.014']
142,32452691,"Stepping Up, Stepping Out: A program description and preliminary findings.","Research on the effects of restricted housing on inmate well-being indicates mild to moderate psychological effects and barriers opportunities for treatment and positive growth. Yet, there are few interventions tailored both to the needs of this high-risk population and to the institutional constraints of their environment. Given the financial and safety burdens associated with housing someone in segregation compared to the general population, correctional psychology should focus on developing programs that work. Using a prepost design, this study presents findings from a pilot investigation (N = 39) on the effects of a new, largely self-directed program (Stepping Up, Stepping Out [SUSO]) for inmates with mental and behavioral health concerns who are placed in restrictive settings. Results suggest that SUSO is associated with meaningful reductions in overall emotional distress and criminal attitudes; however, improvements in more stable criminal thinking patterns (i.e., distorted cognitions that are used to justify and support antisocial behavior; see Walters, 2012) were not observed. Overall, posttreatment working alliance was rated favorably by program participants. Demographic and preintervention comparisons between program completers and dropouts are also reported. Though preliminary findings suggest SUSO is a promising intervention for alleviating distress and aspects of criminal risk for inmates placed in restricted housing, future research should assess fidelity and engagement leading to a randomized controlled trial to determine the effectiveness of this program. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Overall, posttreatment working alliance was rated favorably by program participants.",['inmates with mental and behavioral health concerns who are placed in restrictive settings'],"['SUSO', 'new, largely self-directed program (Stepping Up, Stepping Out [SUSO']",['overall emotional distress and criminal attitudes'],"[{'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0623546,"Overall, posttreatment working alliance was rated favorably by program participants.","[{'ForeName': 'Ashley B', 'Initials': 'AB', 'LastName': 'Batastini', 'Affiliation': 'School of Psychology, University of Southern Mississippi.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Lester', 'Affiliation': 'School of Psychology, University of Southern Mississippi.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychology, Texas Tech University.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Atterberry', 'Affiliation': 'Corizon Health, Inc.'}]",Psychological services,['10.1037/ser0000430']
143,32449896,Peritoneal Flap in Robot-Assisted Radical Prostatectomy.,"BACKGROUND


Lymphocele is the most common complication arising after pelvic lymph node dissection (PLND) in the setting of robot-assisted radical prostatectomy (RARP). The only data available until now on the utility of a peritoneal flap to prevent lymphocele were retrospectively acquired.
METHODS


A randomized, controlled, multi-center trial with blinded assessment of endpoints was carried out on 232 patients with prostate cancer who underwent RARP with PLND. The patients in the intervention group were given a peritoneal flap; in the control group, surgery was performed without this modification. The two joint primary endpoints were the rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2). The secondary endpoints were lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence. German Clinical Trials Register number: DRKS00011115.
RESULTS


The data were evaluated in an intention-to-treat analysis, which, in this trial, was identical to an as-treated analysis. 108 patients (46.6%) were allotted to the intervention group. There were no statistically significant intergroup differences with respect to any clinical or histopathological criteria. A median of 16 lymph nodes were removed (interquartile range, 11-21). A symptomatic lymphocele arose in 1.3% (iT1) and 9.1% (iT2) of the patients, without any statistically significant difference between the two trial groups (p = 0.599 and p = 0.820, respectively). Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2). 81.5% of all patients (n = 189) had no complications at all in the first three months after surgery. Nor were there any intergroup differences at 90 days with respect to the degree of stress urinary incontinence (p = 0.306) or complications (p = 0.486).
CONCLUSION


A peritoneal flap after RARP was not found to influence the rate of postoperative lymphocele, whether asymptomatic or requiring treatment.",2020,"Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2).","['232 patients with prostate cancer who underwent RARP with PLND', '108 patients (46.6']","['Peritoneal Flap in Robot-Assisted Radical Prostatectomy', 'peritoneal flap', 'robot-assisted radical prostatectomy (RARP']","['degree of stress urinary incontinence', 'rate of postoperative lymphocele', 'lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence', 'rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2', 'lymphocele volume', 'symptomatic lymphocele', 'no complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C1998084', 'cui_str': 'Lymphocele after surgical procedure'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",232.0,0.0672329,"Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2).","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bründl', 'Affiliation': 'Department of Urology, University of Regensburg, Caritas St. Josef Medical Center, Regensburg, Germany; Department of Urology and Andrology, Hospital of St. John of God (Krankenhaus der Barmherzigen Brüder Wien), Vienna, Austria; Department of Urology and Andrology, Paracelsus Medical University Salzburg, Salzburg, Austria; Department of Urology, St. Elisabeth Hospital Straubing, Straubing, Germany; Department of Urology, Vivantes Humboldt Hospital Berlin, Berlin Germany; These two authors are co-first authors.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lenart', 'Affiliation': ''}, {'ForeName': 'Gjoko', 'Initials': 'G', 'LastName': 'Stojanoski', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gilfrich', 'Affiliation': ''}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Rosenhammer', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stolzlechner', 'Affiliation': ''}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Ponholzer', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dreissig', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Weikert', 'Affiliation': ''}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Burger', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'May', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0243']
144,32444901,"A Randomized Controlled Trial of a Texting Intervention to Maintain Sexual Risk Reduction with Clients Among Female Sex Workers in Tijuana and Ciudad Juarez, Mexico.","Mobile phone technology may help sustain reductions in HIV/STI transmission risk behaviors among female sex workers (FSWs). We examined the efficacy of a text messaging intervention designed to maintain behavioral improvements in safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico. We hypothesized that FSWs who received brief risk reduction counseling and theory-based safer sex maintenance text messages over a 24-month period would have fewer incident HIV/STIs and report greater maintenance of safer sex practices compared to FSWs who received counseling and texts on maintaining general health. Theory-based texts did not change the odds of becoming infected with HIV/STIs in either study site. However, they did lead to significant, sustained protected sex in Tijuana. Theory-based text messaging interventions may help sustain reductions in sexual risk behavior among FSWs.Trial Registration Clinical Trials.gov. Identifier: NCT02447484.",2020,"We examined the efficacy of a text messaging intervention designed to maintain behavioral improvements in safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico.","['Clients Among Female Sex Workers in Tijuana and Ciudad Juarez, Mexico', 'female sex workers (FSWs', 'safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico']","['brief risk reduction counseling and theory-based safer sex maintenance text messages', 'Texting Intervention', 'text messaging intervention']",[],"[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]",[],,0.0894895,"We examined the efficacy of a text messaging intervention designed to maintain behavioral improvements in safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico.","[{'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Patterson', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA. tpatterson@ucsd.edu.'}, {'ForeName': 'Eileen V', 'Initials': 'EV', 'LastName': 'Pitpitan', 'Affiliation': 'School of Social Work, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Pines', 'Affiliation': 'Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Shirley J', 'Initials': 'SJ', 'LastName': 'Semple', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Harvey-Vera', 'Affiliation': 'Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Depp', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Moore', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Federación Méxicana de Asociaciones Privadas (FEMAP), Ciudad Juarez, Chihuahua, Mexico.'}, {'ForeName': 'M Gudelia', 'Initials': 'MG', 'LastName': 'Rangel', 'Affiliation': 'US-Mexico Border Health Commission, Tijuana, Baja California, Mexico.'}, {'ForeName': 'Steffanie A', 'Initials': 'SA', 'LastName': 'Strathdee', 'Affiliation': 'Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02930-1']
145,32453288,A Randomized Internet-Based Pilot Feasibility and Planning Study of Cherry Extract and Diet Modification in Gout.,"OBJECTIVE


The aim of this study was to conduct a 9-month pilot Internet randomized controlled trial (RCT) of cherry extract and diet modification in gout to assess the feasibility of an Internet study and obtain effect estimates.
METHODS


After providing online informed consent in response to Internet advertisements and social media or clinic flyers, 84 people with physician-confirmed gout were randomized to either cherry extract 3,600 mg/d (n = 41) or dietitian-assisted diet modification for gout (n = 43). All study outcomes were collected via Internet and phone calls. The primary objective was the feasibility of an Internet study, and secondary objectives were to obtain effect estimates for gout flares, functional ability assessed with the Health Assessment Questionnaire (HAQ), and adverse events (AEs) for future trials.
RESULTS


Of the 84 people randomized, overall completion rates were more than 80% for most study procedures up to 6 months and similar for the 2 active comparators. Improvements were seen in gout flares and HAQ scores in cherry extract and diet modification groups at 9 months compared with baseline: gout flares per month, 0.22 versus 0.36 (p = 0.049) and 0.28 versus 0.31 (p = 0.76); proportion with any gout flare, 56% versus 98% (p < 0.0001) and 65% versus 98% (p = 0.0002); and mean ± standard deviation HAQ score, 0.28 ± 0.54 versus 0.55 ± 0.68 (p = 0.001) and 0.23 ± 0.40 versus 0.48 ± 0.61 (p = 0.06), respectively. Any AEs and gastrointestinal symptoms/AEs at 9 months in cherry extract and diet modification groups were 3% versus 0% and 28% versus 27%, respectively.
CONCLUSIONS


An Internet gout RCT is feasible for nonpharmacological gout treatments. A hypothesis-testing, large Internet RCT of cherry extract versus placebo is needed.",2020,"Improvements were seen in gout flares and HAQ scores in cherry extract and diet modification groups at 9 months compared with baseline: gout flares per month, 0.22 versus 0.36 (p = 0.049) and 0.28 versus 0.31 (p = 0.76); proportion with any gout flare, 56% versus 98% (p < 0.0001) and 65% versus 98% (p = 0.0002); and mean ± standard deviation HAQ score, 0.28 ± 0.54 versus 0.55 ± 0.68 (p = 0.001) and 0.23 ± 0.40 versus 0.48 ± 0.61 (p = 0.06), respectively.","['Gout', '84 people randomized', '84 people with physician-confirmed gout']","['RCT', 'cherry extract 3,600 mg/d (n = 41) or dietitian-assisted diet modification', 'cherry extract and diet modification', 'Cherry Extract and Diet Modification', 'placebo']","['gout flares, functional ability assessed with the Health Assessment Questionnaire (HAQ), and adverse events (AEs', 'overall completion rates', 'gout flares and HAQ scores']","[{'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0330657', 'cui_str': 'Prunus cerasus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149896', 'cui_str': 'Primary gout'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2960025', 'cui_str': 'Health assessment questionnaire score'}]",84.0,0.143097,"Improvements were seen in gout flares and HAQ scores in cherry extract and diet modification groups at 9 months compared with baseline: gout flares per month, 0.22 versus 0.36 (p = 0.049) and 0.28 versus 0.31 (p = 0.76); proportion with any gout flare, 56% versus 98% (p < 0.0001) and 65% versus 98% (p = 0.0002); and mean ± standard deviation HAQ score, 0.28 ± 0.54 versus 0.55 ± 0.68 (p = 0.001) and 0.23 ± 0.40 versus 0.48 ± 0.61 (p = 0.06), respectively.","[{'ForeName': 'Jasvinder A', 'Initials': 'JA', 'LastName': 'Singh', 'Affiliation': 'From the Medicine Service, VA Medical Center, Birmingham, AL.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Division of Clinical Immunology and Rheumatology.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Morgan', 'Affiliation': 'Division of Clinical Immunology and Rheumatology.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Willig', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine at School of Medicine.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Darnell', 'Affiliation': 'Department of Nutrition.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'Division of Clinical Immunology and Rheumatology.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Viocare, Princeton, NJ.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McGwin', 'Affiliation': 'Department of Epidemiology, School of Public Health.'}]",Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases,['10.1097/RHU.0000000000001004']
146,32556157,Entecavir Plus Pegylated Interferon and Sequential Hepatitis B Virus Vaccination Increases Hepatitis B Surface Antigen Seroclearance: A Randomized Controlled Proof-of-Concept Study.,"BACKGROUND


Hepatitis B surface antigen (HBsAg) seroclearance is considered a functional cure for patients with chronic hepatitis B, but is rarely achievable with oral nucleos(t)ide analogues alone. We conducted a randomized controlled proof-of-concept trial to evaluate the impact of adding pegylated interferon (peg-IFN) alfa-2a plus sequential or concomitant hepatitis B virus (HBV) vaccination.
METHODS


A total of 111 patients who achieved serum HBV DNA <20 IU/mL and quantitative HBsAg <3000 IU/mL with entecavir were randomly assigned (1:1:1) to the E + sVIP group (entecavir + peg-IFN alfa-2a [180 µg every week over 48 weeks] plus sequential HBV vaccination [20 µg of HBsAg on weeks 52, 56, 60, and 76]), the E + cVIP group (entecavir + peg-IFN alfa-2a + concomitant HBV vaccination [weeks 4, 8, 12, and 28]), or the control group (entecavir only). The primary endpoint was HBsAg seroclearance at week 100, and secondary endpoints included safety.
RESULTS


No differences in baseline quantitative HBsAg were observed among the groups. The E + sVIP group in the intention-to-treat analysis showed a significantly higher chance of HBsAg seroclearance during week 100 than the control group (16.2% vs 0%; P = .025), but the E + cVIP group (5.4%) failed to reach a significant difference (P = .54). Adverse events were significantly more frequent in the E + sVIP (81.1%) and E + cVIP group (70.3%) than the control group (2.7%) (both P < .0001). However, the frequency of serious adverse events did not differ significantly among the 3 groups (2.7%, 5.4%, and 2.7%, respectively; P = 1.00).
CONCLUSIONS


Entecavir plus an additional peg-IFN alfa-2a treatment followed by sequential HBV vaccination under an intensified schedule significantly increases the chance of HBsAg seroclearance compared to entecavir alone.
CLINICAL TRIALS REGISTRATION


NCT02097004.",2021,Adverse events were significantly more frequent in the E+sVIP (81.1%) or E+cVIP group (70.3%) than the control group (2.7%) (both P<0.0001).,"['patients with chronic hepatitis B', 'A total of 111 patients who achieved serum HBV DNA <20 IU/mL and quantitated HBsAg (qHBsAg', 'HBsAg Seroclearance']","['E+cVIP group (entecavir + Peg-IFN alfa-2a + concomitant HBV vaccination', 'E+sVIP', 'control group (entecavir', 'pegylated interferon (Peg-IFN) alfa-2a plus sequential or concomitant hepatitis B virus (HBV) vaccination', 'Entecavir Plus Pegylated Interferon and Sequential HBV', 'E+sVIP group (entecavir + Peg-IFN alfa-2a [180 µg every week over 48 weeks] + sequential HBV vaccination', 'E+cVIP']","['HBsAg seroclearance', 'Adverse events', 'frequency of serious adverse events', 'safety', 'chance of HBsAg seroclearance', 'baseline qHBsAg']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0019378', 'cui_str': 'Cercopithecine herpesvirus 1'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0021734', 'cui_str': 'Interferon Alfa-2a'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",111.0,0.0779048,Adverse events were significantly more frequent in the E+sVIP (81.1%) or E+cVIP group (70.3%) than the control group (2.7%) (both P<0.0001).,"[{'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yun Bin', 'Initials': 'YB', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Su Jong', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa807']
147,32565102,"Sensory interventions on motor function, activities of daily living, and spasticity of the upper limb in people with stroke: A randomized clinical trial.","STUDY DESIGN


This is a single-blinded clinical trial study. Clinical Trial Number registry: IRCT201610223551N4.
INTRODUCTION


Stroke is the second cause of death around the world. Motor and sensory problems are common complications of the stroke. These defects in the upper limb cause reduced use of the affected limb and consequently a decrease in the quality of life.
PURPOSE OF THE STUDY


The purpose of this study was to examine the effect of exteroceptive and proprioceptive stimulations on motor function, spasticity of the upper limb, and activities of daily living in people who have had stroke.
METHODS


Sixty people with chronic stroke selected by convenience sampling. Before the intervention, Modified Ashworth Scale, Fugl-Meyer assessment of Motor Recovery after Stroke, and Barthel Index were measured and then the intervention phase was started. Exteroceptive and proprioceptive sensory stimulations were performed for 6 weeks. Independent t-test was used to compare groups.
RESULTS


The intervention group made improvement in motor function (P = .0001, Cohen's d = 2.14), activities of daily living of upper limb (P = .0001, Cohen's d = 1.32), and spasticity (P = .002, Cohen's d = -0.94).
DISCUSSION


Motor function and activities of daily living and spasticity of the upper limb can be improved through exteroceptive and proprioceptive stimulations. In this study, this type of intervention had the most impact on motor function compared with the rest.
CONCLUSION


Exteroceptive and proprioceptive stimulations in upper limb can be used in chronic phase of stroke. Improvement in motor function and activities of daily living and reducing spasticity are the results of these stimulations.",2021,"The intervention group made improvement in motor function (P = .0001, Cohen's d = 2.14), activities of daily living of upper limb (P = .0001, Cohen's d = 1.32), and spasticity (P = .002, Cohen's d = -0.94).
","['Sixty people with chronic stroke selected by convenience sampling', 'people with stroke', 'people who have had stroke']","['Exteroceptive and proprioceptive stimulations', 'Sensory interventions', 'exteroceptive and proprioceptive stimulations']","['quality of life', 'Exteroceptive and proprioceptive sensory stimulations', 'motor function and activities of daily living and reducing spasticity', 'motor function, spasticity of the upper limb, and activities of daily living', 'activities of daily living of upper limb', 'spasticity', 'motor function, activities of daily living, and spasticity of the upper limb', 'motor function', 'Modified Ashworth Scale, Fugl-Meyer assessment of Motor Recovery after Stroke, and Barthel Index']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",60.0,0.0669052,"The intervention group made improvement in motor function (P = .0001, Cohen's d = 2.14), activities of daily living of upper limb (P = .0001, Cohen's d = 1.32), and spasticity (P = .002, Cohen's d = -0.94).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Derakhshanfar', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Raji', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: praji@tums.ac.ir.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Bagheri', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Jalili', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Tarhsaz', 'Affiliation': 'School of Razi, Kermanshah, Iran.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.03.028']
148,32565105,Home exercise in the dart-throwing motion plane after distal radius fractures: A pilot randomized controlled trial.,"INTRODUCTION


During daily functions, our wrist moves through an oblique plane, named the dart-throwing motion (DTM) plane. This plane is considered a more stable plane because the proximal carpal row remains relatively immobile. However, rehabilitation programs that incorporate exercising in the DTM plane have yet to be explored.
PURPOSE OF THE STUDY


The purpose of this study was to evaluate the rehabilitation outcomes after treatment in the DTM plane compared with outcomes after treatment in the sagittal plane after distal radius fracture.
STUDY DESIGN


This is a pilot randomized controlled trial.
METHODS


Subjects after open reduction internal fixation were assigned into a research group (N = 12; ages 48.7 ± 7.3) and a control group (N = 12; ages 50.8 ± 15). The control group activated the wrist in the sagittal plane, whereas the research group activated the wrist in the DTM plane. Range of motion, pain levels, functional hand motor skills tests, and satisfaction from self-training exercise were measured before and after a 12-session intervention.
RESULTS


The outcome measures were similar between the treatment groups. The research group reported significantly higher satisfaction rates than the control group on topics such as general satisfaction (research group: 3.4 ± 0.7, control group: 2. 5 ± 1.2, P = .030), motivation to exert oneself (research group: 2.8 ± 1.0, control group: 2.3 ± 1.2, P = .009), progressed function (research group: 3.4 ± 0.7, control group: 2.4 ± 1.1, P = .012), and self-training contribution to the daily function (research group: 3.4 ± 0.7, control group: 2.5 ± 1.2, P = .030).
DISCUSSION AND CONCLUSION


Pilot results do not favor one treatment method over the other. However, exercising in the DTM plane may contribute to the satisfaction of the client and increase self-training motivation.",2021,The creation of automated software for the patient-specific adjustment of orthoses for 3D printing can be the missing link for integration of 3D printing in the clinics.,"['36 occupational therapy students (age 25.4±1.9 years', 'distal radius fractures']",['Home exercise'],"['preparation time and orthosis weight', 'weight of the 3D-printed orthosis']","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]",36.0,0.0227074,The creation of automated software for the patient-specific adjustment of orthoses for 3D printing can be the missing link for integration of 3D printing in the clinics.,"[{'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Kaufman-Cohen', 'Affiliation': 'Department of Occupational Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Yafi', 'Initials': 'Y', 'LastName': 'Levanon', 'Affiliation': 'Department of Occupational Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Occupational Therapy Department, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Friedman', 'Affiliation': 'Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Yona', 'Initials': 'Y', 'LastName': 'Yaniv', 'Affiliation': 'Orthopedic Department, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Portnoy', 'Affiliation': 'Department of Occupational Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: portnoys@tauex.tau.ac.il.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.03.027']
149,32683645,Biomarkers of platelet activation and cardiovascular risk in the DAPT trial.,"Prolonged use of dual antiplatelet therapy (DAPT) post-percutaneous coronary intervention (PCI) has been shown to reduce the risk of major adverse cardiovascular events (MACE), but with increased bleeding. It remains unknown whether biomarkers of platelet activation may be useful for identifying patients at increased risk of MACE. The DAPT study was a randomized trial of 12 versus 30 months of DAPT in patients who underwent PCI. Serum biomarkers [myeloid-related protein (MRP)-8/14, P-selectin, soluble CD-40 ligand (sCD40L)] were assessed in 1399 patients early post-PCI. On-treatment platelet reactivity index (PRI) using VASP phosphorylation was assessed in 443 patients randomized to continued DAPT at 1 year. MACE was defined as CV death, MI, or ischemic stroke. Multivariable models were adjusted for baseline characteristics, index event, and stent type. A stepwise increase in the risk of MACE was observed with increasing tertiles of both MRP-8/14 and P-selectin (p-trend = 0.04 for both). After multivariable adjustment, the adjusted HR (95% CI) for MACE in patients in the top tertile was 1.94 (1.14-3.30) for MRP-8/14 and 1.62 (0.99-2.64) for P-selectin. In contrast, baseline sCD40L was not associated with CV risk. Among patients randomized to continued DAPT, higher on-treatment platelet reactivity was not significantly associated with risk of MACE (p-trend = 0.32; adj-HR T3 vs. T1 1.54, 95% CI 0.20-12.18) or bleeding (P-trend = 0.17; adj-HR 0.25, 95% CI 0.05-1.21). MRP-8/14 and soluble P-selectin may be useful for identifying patients at increased risk of MACE after PCI. The utility of on-treatment platelet function testing requires further study.Clinical Trial Registration https://www.clinicaltrials.gov . Unique identifier NCT00977938.",2021,"Among patients randomized to continued DAPT, higher on-treatment platelet reactivity was not significantly associated with risk of MACE (p-trend = 0.32; adj-HR T3 vs. T1 1.54, 95% CI 0.20-12.18) or bleeding (P-trend = 0.17; adj-HR 0.25, 95% CI 0.05-1.21).","['443 patients randomized to continued DAPT at 1\xa0year', '1399 patients early post-PCI', 'patients who underwent PCI']","['dual antiplatelet therapy (DAPT) post-percutaneous coronary intervention (PCI', 'MACE', 'DAPT']","['Serum biomarkers [myeloid-related protein (MRP)-8/14, P-selectin, soluble CD-40 ligand (sCD40L', 'CV death, MI, or ischemic stroke', 'bleeding', 'risk of MACE', 'treatment platelet reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439677', 'cui_str': 'Myeloid'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",443.0,0.105176,"Among patients randomized to continued DAPT, higher on-treatment platelet reactivity was not significantly associated with risk of MACE (p-trend = 0.32; adj-HR T3 vs. T1 1.54, 95% CI 0.20-12.18) or bleeding (P-trend = 0.17; adj-HR 0.25, 95% CI 0.05-1.21).","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. dberg1@bwh.harvard.edu.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Yeh', 'Affiliation': 'Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mauri', 'Affiliation': 'Medtronic, Minneapolis, MN, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital Heart and Vascular Center, The Lindner Research Center, Cincinnati, OH, USA.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Cutlip', 'Affiliation': 'Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Baim Clinical Research Institute, Boston, MA, USA.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Michelson', 'Affiliation': ""Center for Platelet Research Studies, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Frelinger', 'Affiliation': ""Center for Platelet Research Studies, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Abby L', 'Initials': 'AL', 'LastName': 'Cange', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': ""O'Donoghue"", 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02221-5']
150,32586139,Patients with Obesity Have Better Long-Term Outcomes after Hospitalization for COPD Exacerbation.,"Obesity has been shown to have a paradoxical benefit in a number of conditions, but the long-term effects in obesity after chronic obstructive pulmonary disease (COPD) exacerbation is still unclear. In this study, the effects of obesity on short- and long-term outcomes after a COPD exacerbation were evaluated. This was a secondary analysis of the Rapid Empiric Treatment with Oseltamivir Study (RETOS): a prospective, randomized, unblinded clinical trial. Patients were included in the study if they were hospitalized for acute exacerbation of COPD. Obesity was noted as patients with BMI >30. Clinical outcomes of time to clinical stability, length of stay, and mortality were compared. A total of 301 patients were included in the study, 122 (41%) patients were obese. There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity. Mortality for patients with and without obesity was 3% and 3% at 30 days, 7% and 18% at six months, and 8% and 28% at one year, respectively. After adjusting with multivariable regression analysis, patients with obesity had a significant reduction in odds of dying at one year (adjusted odds ratio (aOR): 0.18; 95% CI: 0.06-0.58;  p  = .004) and at six months (aOR: 0.28; 95% CI: 0.09-0.89;  p  = .031). Our study showed that obesity was associated with reduced mortality at one year and six months after a COPD exacerbation. Although patients with obesity had higher rates of comorbidities, they had reduced mortality at one year after multivariable regression analysis.",2020,There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity.,"['Patients were included in the study if they were hospitalized for acute exacerbation of COPD', 'A total of 301 patients were included in the study, 122 (41%) patients were obese', 'Patients with Obesity']",[],"['reduced mortality', 'Obesity', 'Mortality', 'time to clinical stability, length of stay, and mortality', 'length of stay and time to clinical stability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",301.0,0.17615,There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity.,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'DeLapp', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Glick', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Furmanek', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Ramirez', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cavallazzi', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville School of Medicine, Louisville, KY, USA.'}]",COPD,['10.1080/15412555.2020.1781805']
151,32590001,"A Randomized Trial of Parenteral Nutrition Using a Mixed Lipid Emulsion Containing Fish Oil in Infants of Extremely Low Birth Weight: Neurodevelopmental Outcome at 12 and 24 Months Corrected Age, A Secondary Outcome Analysis.","OBJECTIVE


To examine whether parenteral nutrition using a mixed lipid emulsion containing fish oil improves the neurodevelopmental outcomes of extremely low birth weight infants.
STUDY DESIGN


The study is a secondary outcome analysis of a double-blind randomized trial of 230 extremely low birth weight infants performed at a single level IV neonatal care unit (Medical University Vienna; June 2012 to June 2015). Participants received either a mixed lipid emulsion composed of soybean oil, medium chain triglycerides, olive oil, and fish oil, or a soybean oil-based lipid emulsion for parenteral nutrition. Neurodevelopment of study participants was assessed at 12 and 24 months corrected age (August 2013 to October 2017) using the Bayley Scales of Infant-Toddler Development, third edition.
RESULTS


At discharge, 206 of the 230 study participants were eligible. At 12 and 24 months corrected age, 174 of 206 (85%) and 164 of 206 (80%) infants were evaluated. At 12 months, there was no significant difference in cognitive (mixed lipid: median, 95 [IQR, 85-101]; soybean oil: median, 95 [IQR, 85-100]; P = .71), language (mixed lipid: median, 86 [IQR, 77-94], soybean oil: median, 89 [IQR, 79-94]; P = .48), or motor scores (mixed lipid: median, 88 [IQR, 76-94], soybean oil: median, 88 [IQR, 79-94]; P = .69). At 24 months, there was again no significant difference in cognitive (mixed lipid: median, 95 [IQR, 80-105], soybean oil: median, 95 [IQR, 90-105]; P = .17), language (mixed lipid: median, 89 [IQR, 75-97], soybean oil 89 [IQR, 77-100]; P = .54), and motor scores (mixed lipid: median, 94 [IQR, 82-103], soybean oil: median, 94 [IQR, 85-103]; P = .53).
CONCLUSIONS


Parenteral nutrition using a mixed lipid emulsion containing fish oil did not improve neurodevelopment of extremely low birth weight infants at 12 and 24 months corrected age.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01585935.",2020,Parenteral nutrition using a mixed lipid emulsion containing fish oil did not improve neurodevelopment of ELBW infants at 12 and 24 months corrected age.,"['230 ELBW infants performed at a single level IV neonatal care unit (Medical University Vienna; 06/2012-06/2015', 'infants of extremely low birth weight', 'extremely low birth weight (ELBW) infants', 'Neurodevelopment of study participants was assessed at 12 and 24 months corrected age (08/2013-10/2017) using the Bayley Scales of Infant-Toddler Development, Third edition']","['mixed lipid emulsion composed of soybean oil, medium chain triglycerides, olive oil, and fish oil, or a soybean oil-based lipid emulsion', 'parenteral nutrition', 'mixed lipid emulsion containing fish oil']",[],"[{'cui': 'C0456065', 'cui_str': 'Extremely low birth weight infant'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]",[],230.0,0.224401,Parenteral nutrition using a mixed lipid emulsion containing fish oil did not improve neurodevelopment of ELBW infants at 12 and 24 months corrected age.,"[{'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Thanhaeuser', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Fuiko', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Oberleitner-Leeb', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Brandstaetter', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Binder', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Thajer', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Huber-Dangl', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Haiden', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Eleonore', 'Initials': 'E', 'LastName': 'Pablik', 'Affiliation': 'Section for Medical Statistics, CeMSIIS, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Repa', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria. Electronic address: andreas.repa@meduniwien.ac.at.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.056']
152,32601909,Impact of postoperative complications on survival outcomes in patients with gastric cancer: exploratory analysis of a randomized controlled JCOG1001 trial.,"BACKGROUND


Recent studies have found a negative impact of postoperative complications on long-term survival outcomes, but it has not been confirmed by data obtained from a prospective study with a large sample size. This study investigated the impact of postoperative complications on long-term survival outcomes, and considered the optimal definition of complication, using data from JCOG1001, which compared bursectomy and non-bursectomy for patients with cT3/4a locally advanced gastric cancer.
METHODS


This study included 1191 of 1204 patients enrolled in the JCOG1001 trial. Complications were graded by Clavien-Dindo (C-D) classification. Impact of the grade (≥ C-D grade II or ≥ grade III) or type (any or intra-abdominal infectious) of complication on survival outcome was evaluated by univariate and multivariable analyses using the Cox proportional hazard model.
RESULTS


The incidence of any ≥ C-D grade II and ≥ grade III complication was 23.0% and 9.7%, respectively, and that of ≥ grade II and ≥ grade III intra-abdominal infectious complication was 13.4% and 6.9%, respectively. Multivariable analysis showed all four definitions of complications were independent prognostic factors for overall survival. Conversely, only  any ≥ C-D grade III complication was found to be an independent prognostic factor for relapse-free survival (hazard ratio, 1.445; 95% confidence interval, 1.026-2.036; P = 0.035).
CONCLUSIONS


Postoperative complications adversely affect the long-term survival outcomes of patients with cT3/4a gastric cancer. Any ≥ C-D grade III complication seems to be the most suitable definition of complication for predicting negative long-term survival outcomes.",2021,Multivariable analysis showed all four definitions of complications were independent prognostic factors for overall survival.,"['patients with gastric cancer', 'patients with cT3/4a gastric cancer', 'patients with cT3/4a locally advanced gastric cancer', '1191 of 1204 patients enrolled in the JCOG1001 trial']",[],"['overall survival', 'grade III intra-abdominal infectious complication', 'relapse-free survival', 'incidence of any\u2009≥\u2009C-D grade II and\u2009≥\u2009grade III complication', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1204.0,0.195615,Multivariable analysis showed all four definitions of complications were independent prognostic factors for overall survival.,"[{'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Gastrointestinal Surgery, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan. tokunaga.srg1@tmd.ac.jp.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Machida', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yabusaki', 'Affiliation': 'Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Hato', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Mikihito', 'Initials': 'M', 'LastName': 'Nakamori', 'Affiliation': 'Second Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Nagaizumi, Japan.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01102-3']
153,32592516,A Randomized Sham-Controlled Cross-Over Study on the Short-Term Effect of Non-Invasive Cervical Vagus Nerve Stimulation on Spinal and Supraspinal Nociception in Healthy Subjects.,"OBJECTIVE


The aim of the present study was to test the effects of vagus nerve stimulation (VNS) on the descending pain inhibition, quantified by the nociceptive flexor (RIII) reflex and the conditioned pain modulation (CPM) paradigm, and on supraspinal nociceptive responses, assessed by pain intensity and unpleasantness ratings and late somatosensory evoked potentials (SEPs), in healthy subjects.
BACKGROUND


Non-invasive vagus nerve stimulation (nVNS) showed promising effects on headache and pain treatment. Underlying mechanisms are only incompletely understood but may include the activation of the descending pain inhibitory system and/or the modification of emotional responses to pain.
METHODS


Twenty-seven adult, healthy, and pain-free subjects participated in this double-blind cross-over study conducted at a university research center. They received 4 minutes of cervical nVNS or sham stimulation in randomized order. RIII reflexes, pain ratings, and SEPs were assessed before, during, and 5, 15, 30, and 60 minutes after nVNS/sham stimulation, followed by CPM testing. The primary outcome was the nVNS effect on the RIII reflex size. Three subjects were excluded after the preparatory session (before randomization), 1 subject was excluded after outlier analysis, leaving 23 for analysis.
RESULTS


RIII reflex areas were 917.1 ± 563.8 µV × ms (mean ± SD) before, 952.4 ± 467.4 µV × ms during and 929.2 ± 484.0 µV × ms immediately after nVNS and 858.4 ± 489.2 µV × ms before, 913.9 ± 539.7 µV × ms during and 862.4 ± 476.0 µV × ms after sham stimulation, revealing no differences between the immediate effects of nVNS and sham stimulation (F  [3,66]   = 0.67, P = .574). There also were no effects of nVNS over sham on RIII reflex areas up to 60 minutes after nVNS (F  [1.7,37.4]   = 1.29, P = .283). Similarly, there was no statistically significant effect of nVNS on pain intensity ratings and thresholds, RIII reflex thresholds, late SEP amplitudes, and the CPM effect, compared to sham. Pain unpleasantness ratings statistically significantly decreased from 4.4 ± 2.4 (NRS 0-10) to 4.1 ± 2.5 during nVNS compared to sham stimulation (F  [1,22]   = 8.74, P = .007), but there were no longer lasting effects (5-60 minutes after stimulation).
CONCLUSIONS


The present study does not support an acute effect of nVNS on descending pain inhibition, pain intensity perception or supraspinal nociception in healthy adults. However, there was a small effect on pain unpleasantness during nVNS, suggesting that nVNS may preferentially act on affective, not somatosensory pain components.",2020,"Pain unpleasantness ratings statistically significantly decreased from 4.4 ± 2.4 (NRS 0-10) to 4.1 ± 2.5 during nVNS compared to sham stimulation (F  [1,22]   = 8.74, P = .007), but there were no longer lasting effects (5-60 minutes after stimulation).
","['RIII reflex areas were 917.1\xa0±\xa0563.8', '476.0', 'healthy subjects', 'Twenty-seven adult, healthy, and pain-free subjects participated in this double-blind cross-over study conducted at a university research center', 'healthy adults', 'Healthy Subjects']","['Non-Invasive Cervical Vagus Nerve Stimulation', 'vagus nerve stimulation (VNS', 'nVNS', 'Non-invasive vagus nerve stimulation (nVNS', 'cervical nVNS or sham stimulation']","['nVNS effect on the RIII reflex size', 'headache and pain treatment', 'Spinal and Supraspinal Nociception', 'RIII reflexes, pain ratings, and SEPs', 'Pain unpleasantness ratings', 'pain intensity ratings and thresholds, RIII reflex thresholds, late SEP amplitudes, and the CPM effect', 'pain unpleasantness', 'pain intensity and unpleasantness ratings and late somatosensory evoked potentials (SEPs', 'RIII reflex areas', 'mean\xa0±\xa0SD', 'nociceptive flexor (RIII) reflex and the conditioned pain modulation (CPM']","[{'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0277847', 'cui_str': 'Flexion spinal defense reflex'}]",3.0,0.21542,"Pain unpleasantness ratings statistically significantly decreased from 4.4 ± 2.4 (NRS 0-10) to 4.1 ± 2.5 during nVNS compared to sham stimulation (F  [1,22]   = 8.74, P = .007), but there were no longer lasting effects (5-60 minutes after stimulation).
","[{'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Alt', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wach', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Liebler', 'Affiliation': 'electroCore, Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Straube', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ruscheweyh', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}]",Headache,['10.1111/head.13891']
154,32596783,Multicenter phase III trial of S-1 and cisplatin versus S-1 and oxaliplatin combination chemotherapy for first-line treatment of advanced gastric cancer (SOPP trial).,"BACKGROUND


In East Asia, S-1 plus cisplatin (SP) is one of the standard first-line chemotherapy regimens for metastatic or recurrent gastric cancer (MRGC). Oxaliplatin is generally less toxic and more convenient to administer than cisplatin.
PATIENTS AND METHODS


This was a multicenter, phase III study assessing whether S-1/oxaliplatin (SOX) was non-inferior/superior to SP in terms of progression-free survival (PFS). Patients with MRGC were randomized 1:1 to receive either SOX (S-1 80 mg/m 2 /day on days 1-14; oxaliplatin 130 mg/m 2  on day 1; every 3 weeks) or SP (S-1 80 mg/m 2 /day on days 1-14; cisplatin 60 mg/m 2  on day 1; every 3 weeks [SP3]).
RESULTS


Between October 2012 and October 2014, 338 patients were randomized. The median age was 56 years, and 51% of patients had measurable lesions. SOX was significantly non-inferior but not superior to SP3 in terms of PFS [median 5.6 versus 5.7 months; hazard ratio (HR) 0.85; 95% confidence interval (CI) 0.67-1.07]. In patients with measurable disease, objective response rates were similar between SOX and SP3 (58% versus 60%). Overall, the survival in both groups did not differ (median 12.9 versus 11.4 months; HR 0.86; 95% CI 0.66-1.11). Treatment was well tolerated in both arms. Anemia, leucopenia, neutropenia, febrile neutropenia, and oral mucositis were more common with SP3. In contrast, thrombocytopenia, nausea, vomiting, and peripheral neuropathy were more common with SOX.
CONCLUSIONS


SOX was non-inferior to SP3. The two regimens were well tolerated with different toxicity profiles. The SOX regimen can be recommended as a first-line treatment for MRGC.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01671449.",2021,"In patients with measurable disease, objective response rates were similar between SOX and SP3 (58% versus 60%).","['advanced gastric cancer (SOPP trial', 'Patients with MRGC', 'metastatic or recurrent gastric cancer (MRGC', 'Between October 2012 and October 2014, 338 patients were randomized']","['SOX (S-1 80\xa0mg/m 2 /day on days 1-14; oxaliplatin 130\xa0mg/m 2  on day 1; every 3\xa0weeks) or SP (S-1 80\xa0mg/m 2 /day on days 1-14; cisplatin 60\xa0mg/m 2  on day 1; every 3\xa0weeks [SP3', 'S-1/oxaliplatin (SOX', 'S-1 and cisplatin versus S-1 and oxaliplatin combination chemotherapy', 'Oxaliplatin', 'S-1 plus cisplatin (SP']","['tolerated', 'thrombocytopenia, nausea, vomiting, and peripheral neuropathy', 'survival', 'objective response rates', 'progression-free survival (PFS', 'tolerated with different toxicity profiles', 'Anemia, leucopenia, neutropenia, febrile neutropenia, and oral mucositis', 'SOX']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0278502', 'cui_str': 'Gastric cancer recurrent'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0348086', 'cui_str': 'SP3'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",338.0,0.168688,"In patients with measurable disease, objective response rates were similar between SOX and SP3 (58% versus 60%).","[{'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Ik-Joo', 'Initials': 'IJ', 'LastName': 'Chung', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Republic of Korea.'}, {'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. miniryu@amc.seoul.kr.'}, {'ForeName': 'Young Iee', 'Initials': 'YI', 'LastName': 'Park', 'Affiliation': 'Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea. youngiee@ncc.re.kr.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Ho-Suk', 'Initials': 'HS', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Kyung Hee', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Hye Sook', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Republic of Korea.'}, {'ForeName': 'Bong-Gun', 'Initials': 'BG', 'LastName': 'Seo', 'Affiliation': 'Department of Internal Medicine, Dongnam Institute of Radiological and Medical Sciences, Busan, Republic of Korea.'}, {'ForeName': 'Jae-Cheol', 'Initials': 'JC', 'LastName': 'Jo', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Hyo Rak', 'Initials': 'HR', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Korea Cancer Center Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Sook Ryun', 'Initials': 'SR', 'LastName': 'Park', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Hee', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Republic of Korea.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01101-4']
155,32649327,Cone-Beam CT Image Guidance With and Without Electromagnetic Navigation Bronchoscopy for Biopsy of Peripheral Pulmonary Lesions.,"BACKGROUND


Bronchoscopic diagnosis of small peripheral lung lesions suspected of lung cancer remains a challenge. A successful endobronchial diagnosis comprises navigation, confirmation, and tissue acquisition. In all steps, 3-dimensional information is essential. Cone-beam computed tomography (CBCT) imaging can provide computed tomography information and 3-dimensional augmented fluoroscopy imaging. We assessed whether CBCT imaging can improve navigation and diagnosis of peripheral lesions by 2 clinical workflows with a cross-over design: (1) a primary CBCT and radial endobronchial ultrasound mini probe imaging-based approach and (2) a primary electromagnetic navigation (EMN) and radial endobronchial ultrasound mini probe imaging-based approach.
METHODS


All patients with a peripheral lung lesion biopsy indication were eligible for study inclusion and randomly assigned to study arms. Commercially available equipment was used. The main study goals were to assess CBCT-confirmed navigation success and diagnostic accuracy. Surgery or unambiguous clinical follow-up served as the gold standard.
RESULTS


Eighty-seven patients with 107 lesions were included. Lesion mean longest axis size in the CBCT arm was 16.6 mm (n=47) and 14.2 mm in the EMN arm (n=40). The primary CBCT approach and primary EMN approach had 76.3% and 52.2% navigation success, respectively. Addition of EMN to the CBCT approach increased navigation success to 89.9%. Addition of CBCT imaging to the EMN approach significantly increased navigation success to 87.5% per lesion. The overall diagnostic accuracy per patient was significantly lower than the navigation success, being 72.4%.
CONCLUSION


CBCT imaging is a valuable addition to navigation bronchoscopy. Although overall navigation success was high, the diagnostic accuracy remains to be improved. Future research should focus on improving the tissue acquisition methodology.",2021,"The primary CBCT approach and primary EMN approach had 76.3% and 52.2% navigation success, respectively.","['All patients with a peripheral lung lesion biopsy indication', 'Eighty-seven patients with 107 lesions were included']","['Electromagnetic Navigation Bronchoscopy', 'EMN', 'CBCT imaging', 'Cone-Beam CT Image Guidance', 'Cone-beam computed tomography (CBCT) imaging', 'CBCT', 'radial endobronchial ultrasound mini probe imaging-based approach and (2) a primary electromagnetic navigation (EMN) and radial endobronchial ultrasound mini probe imaging-based approach']","['overall navigation success', 'overall diagnostic accuracy', 'navigation success', 'CBCT-confirmed navigation success and diagnostic accuracy', 'Lesion mean longest axis size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3899273', 'cui_str': 'Electromagnetic navigation bronchoscopy'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0442972', 'cui_str': 'Imaging guidance'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",87.0,0.0827166,"The primary CBCT approach and primary EMN approach had 76.3% and 52.2% navigation success, respectively.","[{'ForeName': 'Roel L J', 'Initials': 'RLJ', 'LastName': 'Verhoeven', 'Affiliation': 'Departments of Pulmonology.'}, {'ForeName': 'Jurgen J', 'Initials': 'JJ', 'LastName': 'Fütterer', 'Affiliation': 'Radiology and Nuclear Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Hoefsloot', 'Affiliation': 'Departments of Pulmonology.'}, {'ForeName': 'Erik H F M', 'Initials': 'EHFM', 'LastName': 'van der Heijden', 'Affiliation': 'Departments of Pulmonology.'}]",Journal of bronchology & interventional pulmonology,['10.1097/LBR.0000000000000697']
156,32610115,Suboptimal reliability of liver biopsy evaluation has implications for randomized clinical trials.,"BACKGROUND & AIMS


Liver biopsies are a critical component of pivotal studies in non-alcoholic steatohepatitis (NASH), constituting inclusion criteria, risk stratification factors and endpoints. We evaluated the reliability of NASH Clinical Research Network scoring of liver biopsies in a NASH clinical trial.
METHODS


Digitized slides of 678 biopsies from 339 patients with paired biopsies randomized into the EMMINENCE study - examining a novel insulin sensitizer (MSDC-0602K) in NASH - were read independently by 3 hepatopathologists blinded to treatment code and scored using the NASH CRN histological scoring system. Various endpoints were computed from these scores.
RESULTS


Inter-reader linearly weighted kappas were 0.609, 0.484, 0.328, and 0.517 for steatosis, fibrosis, lobular inflammation, and ballooning, respectively. Inter-reader unweighted kappas were 0.400 for the diagnosis of NASH, 0.396 for NASH resolution without worsening fibrosis, and 0.366 for fibrosis improvement without worsening NASH. In the current study, 46.3% of the patients included in the study based on 1 hepatopathologist's qualifying reading were deemed not to meet the study's histologic inclusion criteria by at least 1 of the 3 hepatopathologists. The MSDC-0602K treatment effect was lowest for those histologic features with lower inter-reader reliability. Simulations show that the lack of reliability of endpoints and inclusion criteria can drastically reduce study power - from >90% in a well-powered study to as low as 40%.
CONCLUSIONS


The reliability of hepatopathologists' liver biopsy evaluation using currently accepted criteria is suboptimal. This lack of reliability may affect NASH pivotal studies by introducing patients who do not meet NASH study entry criteria, misclassifying fibrosis subgroups, and attenuating apparent treatment effects.
LAY SUMMARY


Since liver biopsy analysis plays such an important role in clinical studies of non-alcoholic steatohepatitis, it is important to understand the reliability of hepato-pathologist readings. We examined both inter- and intra-reader variability in a large data set of paired liver biopsies from a clinical trial. We found very poor inter-reader and modest intra-reader variability. This result has important implications for entry criteria, fibrosis stratification, and the ability to measure a treatment effect in clinical trials.",2020,"RESULTS


Inter-reader linearly weighted kappas were 0.609, 0.484, 0.328, and 0.517 for steatosis, fibrosis, lobular inflammation, and ballooning, respectively.",['Digitized slides from 678 biopsies for 339 patients with paired biopsies'],['novel insulin sensitizer (MSDC-0602K'],[],"[{'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0644896', 'cui_str': '10-methyl spiro(4.5)dec-6-en-6-carboxylic acid'}]",[],678.0,0.0934253,"RESULTS


Inter-reader linearly weighted kappas were 0.609, 0.484, 0.328, and 0.517 for steatosis, fibrosis, lobular inflammation, and ballooning, respectively.","[{'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Davison', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA. Electronic address: bethdavison@momentum-research.com.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Hepatology, Radcliffe Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Texas Liver Institute, San Antonio, TX, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Edwards', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Jerry R', 'Initials': 'JR', 'LastName': 'Colca', 'Affiliation': 'Cirius Therapeutics, Inc., San Diego, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Iwashita', 'Affiliation': 'Cirius Therapeutics, Inc., San Diego, CA, USA.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Koch', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Dittrich', 'Affiliation': 'Cirius Therapeutics, Inc., San Diego, CA, USA.'}]",Journal of hepatology,['10.1016/j.jhep.2020.06.025']
157,32633650,Viewing nature scenes reduces the pain of social ostracism.,"In a series of four studies ( N s = 245, 135, 155, 222), we explored the effects of viewing nature scenes on promoting recovery from ostracism. We first manipulated experiences of ostracism, then randomly assigned participants to view photos of either nature, urban scenes, or neutral objects. Across all four studies, participants who viewed nature photos reported significantly lower levels of state social pain, along with significantly higher levels of affect balance and self-esteem. Moreover, when asked to look back and recall how they felt at the time of being ostracized, participants who viewed nature photos reported significantly higher levels of retrospective satisfaction of basic emotional needs than did participants in control conditions. An internal meta-analysis revealed an effect size of  d  = 0.58. These studies are the first, to our knowledge, to provide experimental evidence of how exposure to nature can alleviate the pain of social ostracism.",2021,"Across all four studies, participants who viewed nature photos reported significantly lower levels of state social pain, along with significantly higher levels of affect balance and self-esteem.",[],[],"['balance and self-esteem', 'pain of social ostracism', 'retrospective satisfaction of basic emotional needs', 'levels of state social pain']",[],[],"[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.0343304,"Across all four studies, participants who viewed nature photos reported significantly lower levels of state social pain, along with significantly higher levels of affect balance and self-esteem.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Lishen', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Education College, Shaoguan University, Shaoguan, China.'}, {'ForeName': 'Holli-Anne', 'Initials': 'HA', 'LastName': 'Passmore', 'Affiliation': 'Nature Connectedness Group, University of Derby, Derby, United Kingdom.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, University of British Columbia, British Columbia, Canada.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Mental Health Education & Counseling Centre, Zhejiang Ocean University, Zhoushan, China.'}, {'ForeName': 'Huajian', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology Chinese Academy of Sciences, Beijing, China.'}]",The Journal of social psychology,['10.1080/00224545.2020.1784826']
158,32634275,Evaluation of 2-Hour Post-Dose Efficacy of Lasmiditan for the Acute Treatment of Difficult-to-Treat Migraine Attacks.,"OBJECTIVE


To identify factors predicting response (2-hour headache pain freedom or most bothersome symptom freedom) to lasmiditan based on individual patient characteristics, migraine disease characteristics, and migraine attack characteristics. Further, efficacy specifically in difficult-to-treat patient/migraine disease characteristics or attack characteristics (ie, historically considered less responsive to certain acute therapies) subgroups was analyzed.
BACKGROUND


Knowledge of factors associated with a positive or negative response to acute treatment would be useful to practitioners prescribing acute treatments for migraine. Additionally, practitioners and patients would benefit from understanding the efficacy of lasmiditan specifically in subgroups of patients with migraine disease characteristics and migraine attack characteristics historically associated with decreased pain threshold, reduced efficacy of acute treatment, or increased burden of migraine.
METHODS


Pooled analyses were completed from 2 Phase 3 double-blind clinical trials, SPARTAN and SAMURAI. Data from baseline to 2 hours after taking lasmiditan (50, 100, or 200 mg) or placebo were analyzed to assess efficacy based on patient characteristics, migraine disease characteristics, and migraine attack characteristics. A total of 3981 patients comprising the intent-to-treat population were treated with placebo (N = 1130), lasmiditan 50 mg (N = 598), lasmiditan 100 mg (N = 1133), or lasmiditan 200 mg (N = 1120). Data were analyzed for the following efficacy measures at 2 hours: headache pain freedom and most bothersome symptom freedom.
RESULTS


None of the analyzed subgroups based on individual patient characteristics, migraine disease characteristics, or migraine attack characteristics predicted headache pain freedom or most bothersome symptom freedom response at 2 hours following lasmiditan treatment (interaction P ≥ .1). For the difficult-to-treat patient/migraine disease characteristics subgroups (defined as those with ≥24 headache days in the past 3 months, duration of migraine history ≥20 years, severe disability [Migraine Disability Assessment score ≥21], obesity [≥30 kg/m 2  ], and history of psychiatric disorder), single doses of lasmiditan (100 or 200 mg) were significantly more effective than placebo (P ≤ .002) in achieving both endpoints. Headache pain freedom response rates for higher doses of lasmiditan were numerically greater than for lower doses of lasmiditan. For the difficult-to-treat migraine attack subgroups, patients with severe headache, co-existent nausea at the time of treatment, or who delayed treatment for ≥2 hours from the time of headache onset, both endpoint response rates after lasmiditan 100 or 200 mg were significantly greater than after placebo. Among those who delayed treatment for ≥4 hours from the time of headache onset, headache pain freedom response rates for the 200 mg dose of lasmiditan met statistical significance vs placebo (32.4% vs 15.9%; odds ratio = 2.7 [1.17, 6.07]; P = .018). While the predictors of response interaction test showed similar efficacy of lasmiditan vs placebo across subgroups defined by baseline functional disability (mild, moderate, or needs complete bed rest) at the time of treatment, analyses of lasmiditan efficacy within the subgroup ""needs complete bed rest"" appeared to show less efficacy (eg, in the 200 mg vs placebo group, 25.9% vs 18.5%; odds ratio = 1.56 [0.96, 2.53]; P = .070).
CONCLUSIONS


Efficacy of lasmiditan 200 and 100 mg for headache pain freedom and most bothersome symptom freedom at 2 hours post-treatment was generally not influenced by the individual patient characteristics, migraine disease history, or migraine attack characteristics that were analyzed. In the analyses of difficult-to-treat subgroups, patients receiving lasmiditan achieved greater responses (2-hour headache pain freedom and most bothersome symptom freedom) vs placebo recipients.",2020,Headache pain freedom response rates for higher doses of lasmiditan were numerically greater than for lower doses of lasmiditan.,['3981 patients comprising the intent-to-treat population'],"['Lasmiditan', 'lasmiditan 50\xa0mg (N\xa0=\xa0598), lasmiditan 100\xa0mg (N\xa0=\xa01133), or lasmiditan 200\xa0mg', 'placebo']","['headache pain freedom or most bothersome symptom freedom response', 'time of headache onset, headache pain freedom response rates', 'Headache pain freedom response rates', 'headache pain freedom and most bothersome symptom freedom', 'headache pain freedom', 'duration of migraine history ≥20\xa0years, severe disability [Migraine Disability Assessment score ≥21], obesity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",3981.0,0.177233,Headache pain freedom response rates for higher doses of lasmiditan were numerically greater than for lower doses of lasmiditan.,"[{'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Vasudeva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Suchitrita S', 'Initials': 'SS', 'LastName': 'Rathmann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Bert B', 'Initials': 'BB', 'LastName': 'Vargas', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Magis', 'Affiliation': 'Department of Neurology and Headache and Pain Multimodal Management Clinic, CHR East Belgium Hospital, Verviers, Belgium.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Komori', 'Affiliation': 'Eli Lilly and Company, Kobe, Japan.'}]",Headache,['10.1111/head.13897']
159,32613525,Development and Initial Testing of an mHealth Transitions of Care Intervention for Adults with Schizophrenia-Spectrum Disorders Immediately Following a Psychiatric Hospitalization.,"An important period in the care of patients with schizophrenia-spectrum disorders is when they transition from inpatient to outpatient services and are at increased risk for relapse and rehospitalization. Thus, we developed and examined the initial feasibility, acceptability, and clinical effects of an mHealth transitions of care intervention (Mobile After-Care Support; MACS) in an open trial. Ten adults with schizophrenia-spectrum disorders were recruited during their index psychiatric hospitalization and enrolled prior to discharge. Measures of feasibility, acceptability, and MACS targets were administered at baseline and a 1-month follow-up. Drawing on skills from Cognitive Behavioral Therapy for Psychosis (CBTp), MACS delivered brief assessments of clinically relevant variables, followed by just-in-time interventions for patients starting immediately post-discharge. Individuals completed about one session per day on average as expected. Overall, measures of MACS usability and satisfaction were positive. T-test analyses showed that dysfunctional coping strategies significantly decreased from baseline to 1-month follow-up. Results also revealed statistically significant reductions in psychiatric symptoms over 1-month follow-up. This study demonstrates the feasibility and acceptability of MACS, a new app-based intervention targeting transitions of care for patients with psychosis. The field is turning to the use of mobile technology as a means of augmenting service delivery and providing real-time assessment and intervention for patients at risk. MACS is a promising adjunctive intervention that warrants further testing in a randomized controlled trial.",2021,"This study demonstrates the feasibility and acceptability of MACS, a new app-based intervention targeting transitions of care for patients with psychosis.","['patients with schizophrenia-spectrum disorders', 'Ten adults with schizophrenia-spectrum disorders were recruited during their index psychiatric hospitalization and enrolled prior to discharge', 'patients with psychosis', 'Adults with Schizophrenia-Spectrum Disorders']","['MACS', 'Care Intervention', 'care intervention (Mobile After-Care Support; MACS']","['dysfunctional coping strategies', 'psychiatric symptoms', 'feasibility, acceptability, and MACS targets', 'MACS usability and satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",10.0,0.0587841,"This study demonstrates the feasibility and acceptability of MACS, a new app-based intervention targeting transitions of care for patients with psychosis.","[{'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Moitra', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, 02912, USA. ethan_moitra@brown.edu.'}, {'ForeName': 'Hyun Seon', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, RI, 02906, USA.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Gaudiano', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, 02912, USA.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09792-9']
160,32612251,"Comparing the streamlined psychotherapy ""Engage"" with problem-solving therapy in late-life major depression. A randomized clinical trial.","Effective psychotherapies for late-life depression are underutilized, mainly because of their complexity. ""Engage"" is a novel, streamlined psychotherapy that relies on neurobiology to identify core behavioral pathology of late-life depression and targets it with simple interventions, co-designed with community therapists so that they can be delivered in community settings. Consecutively recruited adults (≥60 years) with major depression (n = 249) were randomly assigned to 9 weekly sessions of ""Engage"" or to the evidence-based Problem-Solving Therapy (PST) offered by 35 trained community social workers and assessed by blind raters. ""Engage"" therapists required an average of 30% less training time to achieve fidelity to treatment than PST therapists and had one-third of the PST therapists' skill drift. Both treatments led to reduction of HAM-D scores over 9 weeks. The mixed effects model-estimated HAM-D ratings were not significantly different between the two treatments at any assessment point of the trial. The one-sided 95% CI for treatment-end difference was (-∞, 0.07) HAM-D points, indicating a non-inferiority margin of 1.3 HAM-D points or greater; this margin is lower than the pre-determined 2.2-point margin. The two treatment arms had similar response (HR = 1.08, 95% CI (0.76, 1.52), p = 0.67) and remission rates (HR = 0.89, 95% CI (0.57, 1.39), p = 0.61). We conclude that ""Engage"" is non-inferior to PST. If disseminated, ""Engage"" will increase the number of therapists who can reliably treat late-life depression and make effective psychotherapy available to large numbers of depressed older adults.",2021,The mixed effects model-estimated HAM-D ratings were not significantly different between the two treatments at any assessment point of the trial.,['Consecutively recruited adults (≥60 years) with major depression (n\u2009=\u2009249'],"['streamlined psychotherapy ""Engage"" with problem-solving therapy', 'Engage"" or to the evidence-based Problem-Solving Therapy (PST']","['remission rates', 'HAM-D ratings', 'HAM-D scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",249.0,0.172505,The mixed effects model-estimated HAM-D ratings were not significantly different between the two treatments at any assessment point of the trial.,"[{'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA. gsalexop@med.cornell.edu.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marino', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Brenna N', 'Initials': 'BN', 'LastName': 'Renn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Adenike', 'Initials': 'A', 'LastName': 'Adeagbo', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Hull', 'Affiliation': 'Talkspace, New York, NY, USA.'}, {'ForeName': 'Dimitris N', 'Initials': 'DN', 'LastName': 'Kiosses', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mauer', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Areán', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}]",Molecular psychiatry,['10.1038/s41380-020-0832-3']
161,32636099,Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial).,"BACKGROUND


Urethral stricture affects 0.9% of men. Initial treatment is urethrotomy. Approximately, half of the strictures recur within 4 yr. Options for further treatment are repeat urethrotomy or open urethroplasty.
OBJECTIVE


To compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture.
DESIGN, SETTING, AND PARTICIPANTS


This was an open label, two-arm, patient-randomised controlled trial. UK National Health Service hospitals were recruited and 222 men were randomised to receive urethroplasty or urethrotomy.
INTERVENTION


Urethrotomy is a minimally invasive technique whereby the narrowed area is progressively widened by cutting the scar tissue with a steel blade mounted on a urethroscope. Urethroplasty is a more invasive surgery to reconstruct the narrowed area.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary outcome was the profile over 24 mo of a patient-reported outcome measure, the voiding symptom score. The main clinical outcome was time until reintervention.
RESULTS AND LIMITATIONS


The primary analysis included 69 (63%) and 90 (81%) of those allocated to urethroplasty and urethrotomy, respectively. The mean difference between the urethroplasty and urethrotomy groups was -0.36 (95% confidence interval [CI] -1.74 to 1.02). Fifteen men allocated to urethroplasty needed a reintervention compared with 29 allocated to urethrotomy (hazard ratio [95% CI] 0.52 [0.31-0.89]).
CONCLUSIONS


In men with recurrent bulbar urethral stricture, both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty.
PATIENT SUMMARY


There was uncertainty about the best treatment for men with recurrent bulbar urethral stricture. We randomised men to receive one of the following two treatment options: urethrotomy and urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer reinterventions.",2020,The mean difference between the urethroplasty and urethrotomy groups was -0.36,"['adult men with recurrent bulbar urethral stricture', 'UK National Health Service hospitals were recruited and 222 men', 'Recurrent Bulbar Urethral Stricture', 'men with recurrent bulbar urethral stricture']","['urethrotomy and urethroplasty', 'urethrotomy with open urethroplasty', 'Urethrotomy', 'urethroplasty or urethrotomy', 'Open Urethroplasty Versus Endoscopic Urethrotomy']","['voiding symptom score', 'reinterventions', 'time until reintervention', 'voiding symptoms', 'effectiveness and cost-effectiveness', 'symptom scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0194550', 'cui_str': 'Incision of urethra'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",222.0,0.165454,The mean difference between the urethroplasty and urethrotomy groups was -0.36,"[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Carnell', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Centre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Breckons', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. Electronic address: luke.vale@ncl.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Whybrow', 'Affiliation': 'Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Rapley', 'Affiliation': 'Social Work, Education and Community Wellbeing, University of Northumbria, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Forbes', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Currer', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forrest', 'Affiliation': 'Centre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilkinson', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Andrich', 'Affiliation': 'University College London Hospital, London, UK.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Barclay', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mundy', 'Affiliation': 'University College London Hospital, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""N'Dow"", 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Payne', 'Affiliation': 'Central Manchester Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Watkin', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pickard', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}]",European urology,['10.1016/j.eururo.2020.06.003']
162,32651477,Modifiable predictors of nonresponse to psychotherapies for late-life depression with executive dysfunction: a machine learning approach.,"The study aimed to: (1) Identify distinct trajectories of change in depressive symptoms by mid-treatment during psychotherapy for late-life depression with executive dysfunction; (2) examine if nonresponse by mid-treatment predicted poor response at treatment end; and (3) identify baseline characteristics predicting an early nonresponse trajectory by mid-treatment. A sample of 221 adults 60 years and older with major depression and executive dysfunction were randomized to 12 weeks of either problem-solving therapy or supportive therapy. We used Latent Growth Mixture Models (LGMM) to detect subgroups with distinct trajectories of change in depression by mid-treatment (6th week). We conducted regression analyses with LGMM subgroups as predictors of response at treatment end. We used random forest machine learning algorithms to identify baseline predictors of LGMM trajectories. We found that ~77.5% of participants had a declining trajectory of depression in weeks 0-6, while the remaining 22.5% had a persisting depression trajectory, with no treatment differences. The LGMM trajectories predicted remission and response at treatment end. A random forests model with high prediction accuracy (80%) showed that the strongest modifiable predictors of the persisting depression trajectory were low perceived social support, followed by high neuroticism, low treatment expectancy, and low perception of the therapist as accepting. Our results suggest that modifiable risk factors of early nonresponse to psychotherapy can be identified at the outset of treatment and addressed with targeted personalized interventions. Therapists may focus on increasing meaningful social interactions, addressing concerns related to treatment benefits, and creating a positive working relationship.",2021,A sample of 221 adults 60 years and older with major depression and executive dysfunction were randomized to 12 weeks of either problem-solving therapy or supportive therapy.,"['221 adults 60 years and older with major depression and executive dysfunction', 'late-life depression with executive dysfunction']","['problem-solving therapy or supportive therapy', 'Latent Growth Mixture Models (LGMM']","['persisting depression trajectory', 'depressive symptoms', 'trajectory of depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",221.0,0.0201383,A sample of 221 adults 60 years and older with major depression and executive dysfunction were randomized to 12 weeks of either problem-solving therapy or supportive therapy.,"[{'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Jihui', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Flückiger', 'Affiliation': 'Psychologisches Institut, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Kanellopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Faith M', 'Initials': 'FM', 'LastName': 'Gunning', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Liston', 'Affiliation': 'Feil Family Brain Mind Research Institute, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Hull', 'Affiliation': 'Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Areán', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA. gsalexop@med.cornell.edu.'}]",Molecular psychiatry,['10.1038/s41380-020-0836-z']
163,32657901,"Effects of a Roy's Adaptation Model-Guided Support Group Intervention on Sexual Adjustment, Body Image, and Perceived Social Support in Women With Breast Cancer.","BACKGROUND


The side effects of local and systemic treatments for breast cancer negatively impact the body image, sexual functioning, and social life of women on treatment for breast cancer. One of the ways to help these women adapt to their disease and cope with the effects of the disease and the side effects of its treatment is through support groups.
OBJECTIVE


The aim of this study was to investigate the effect of a support group intervention, guided by Roy's Adaptation Model, on sexual adaptation, body image, and perceived social support in women on treatment for cancer.
METHODS


The study had a quasi-experimental design with pretests and posttests and a control group. The sample included 79 women, 42 in the control group and 37 in the intervention group. Data were gathered with demographic and clinical forms, the Sexual Adjustment and Body Image Scale, and the Multidimensional Scale of Perceived Social Support. The intervention group received a support group intervention guided by Roy's Adaptation Model.
RESULTS


The intervention group had significantly higher scores for perceived social support, post body image, impact on sexual functioning, and friendly and significant others than the control group did.
CONCLUSION


The Roy's Adaptation Model-based support group intervention contributes positively to physiologic, self-concept, role-function, and interdependence modes by creating a positive effect on body image, improving sexual functions, and increasing social support for women on treatment for breast cancer.
IMPLICATIONS FOR PRACTICE


This support group intervention may enhance care outcomes in women on treatment for cancer and could thus be incorporated into standard care for this patient group.",2021,"The intervention group had significantly higher scores for perceived social support, post body image, impact on sexual functioning, and friendly and significant others than the control group did.
","['79 women, 42 in the control group and 37 in the intervention group', 'Women With Breast Cancer', 'women on treatment for breast cancer', 'women on treatment for cancer']","[""Roy's Adaptation Model-Guided Support Group Intervention"", ""support group intervention, guided by Roy's Adaptation Model, on sexual adaptation, body image, and perceived social support"", ""support group intervention guided by Roy's Adaptation Model""]","['higher scores for perceived social support, post body image, impact on sexual functioning', 'Sexual Adjustment, Body Image, and Perceived Social Support']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]",79.0,0.0220596,"The intervention group had significantly higher scores for perceived social support, post body image, impact on sexual functioning, and friendly and significant others than the control group did.
","[{'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Erol Ursavaş', 'Affiliation': 'Author Affiliations: Faculty of Health Science, Department of Nursing, Çankırı Karatekin University, Çankırı (Dr Erol Ursavaş); and Faculty of Health Science, Department of Nursing, Izmir University of Economics, İzmir, Turkey (Prof Dr Karayurt).'}, {'ForeName': 'Özgül', 'Initials': 'Ö', 'LastName': 'Karayurt', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000854']
164,32668834,Prevention of epidural catheter migration: a comparative evaluation of two tunneling techniques.,"BACKGROUND


Epidural analgesia failure episodes can be reduced by catheter fixation techniques with a lower incidence of catheter migration. In this clinical study, we compared the roles of two epidural catheter tunneling techniques for the prevention of epidural catheter migration.
METHODS


Patients undergoing major abdominal surgery were randomized into three groups of 50 patients each based on the method used to secure the epidural catheter. In the control group (CG), the epidural catheter was secured without tunneling. Tunneling groups 1 and 2 (TG1 and TG2) were defined as tunneling with and without a catheter loop, respectively. The primary outcome measure was the migration of the epidural catheter, while the secondary outcome measures were the adequacy of analgesia and signs of inflammation. All patients were followed up by the acute pain service team twice daily in the postoperative period until the epidural catheter was removed. The results were analyzed by the one-way analysis of variance (ANOVA), chi-square test, and Fisher's exact test. P values <0.050 were considered significant.
RESULTS


The three groups were similar with respect to patient characteristics. Catheter migration was significantly reduced in TG2 (two patients) compared to those in the other two groups, i.e., TG1 (eight patients) (P = 0.045) and CG (17 patients) (P = 0.001). No differences were found amongst the three groups in analgesia adequacy and catheter site inflammation (P > 0.050).
CONCLUSIONS


Catheter migration was significantly reduced by tunneling without a catheter loop in TG2 as compared to the other two groups. Therefore, we suggest routine use of tunneling without a catheter loop technique in anesthesia practice and look forward to future studies with larger sample sizes.",2021,The three groups were similar with respect to patient characteristics; Catheter migration was significantly reduced in the TG2 (3 patients) as compared to other 2 groups i.e. TG1 (8 patients) (P<0.05); and CG (16 patients) (P<0.05).,['Patients undergoing major abdominal surgery'],"['epidural catheter was secured without tunneling; Tunneling group 1 (TG1) where tunneling was done along with a catheter loop; Tunneling group 2 (TG2) where tunneling was done without a catheter loop', 'epidural catheter migration', 'catheter fixation technique']","['adequacy of analgesia and catheter site inflammation', 'Conclusions\n\n\nCatheter migration', 'migration of epidural catheter', 'adequacy of analgesia and signs of inflammation', 'patient characteristics; Catheter migration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0948817', 'cui_str': 'Catheter site inflammation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0479062,The three groups were similar with respect to patient characteristics; Catheter migration was significantly reduced in the TG2 (3 patients) as compared to other 2 groups i.e. TG1 (8 patients) (P<0.05); and CG (16 patients) (P<0.05).,"[{'ForeName': 'Sujeet', 'Initials': 'S', 'LastName': 'Gautam', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Uttar Pradesh, Lucknow, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Uttar Pradesh, Lucknow, India.'}, {'ForeName': 'Pravin Kumar', 'Initials': 'PK', 'LastName': 'Das', 'Affiliation': 'Department of Anesthesiology, Dr Ram Manohar Lohia Institute of Medical Sciences, Uttar Pradesh, Lucknow, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Khuba', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Uttar Pradesh, Lucknow, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Uttar Pradesh, Lucknow, India.'}]",Korean journal of anesthesiology,['10.4097/kja.20131']
165,32665218,"Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial.","OBJECTIVE


To determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair.
DESIGN


Pragmatic, blinded randomized controlled trial.
SETTING


Multidisciplinary hernia clinics in Houston, USA.
PARTICIPANTS


124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019.
INTERVENTIONS


Robotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59).
MAIN OUTCOME MEASURES


The primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat.
RESULTS


Patients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0  v  0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141  v  77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125)  v  $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair.
CONCLUSION


This study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03490266.",2020,"However, robotic repair had longer operative duration (141  v  77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125)  v  $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004).","['patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair', '124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019', 'Multidisciplinary hernia clinics in Houston, USA', 'n=59']","['laparoscopic ventral hernia repair', 'Robotic versus laparoscopic ventral hernia repair', 'robotic ventral hernia repair', 'Robotic ventral hernia repair', 'laparoscopic repair', 'robotic and laparoscopic ventral hernia repair']","['abdominal wall quality of life', 'healthcare costs', 'emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective', 'operative duration and healthcare costs', 'operative duration', 'number of days in hospital within 90 days after surgery', 'emergency department visits, wound complications, hernia recurrence, or reoperation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0192579', 'cui_str': 'Incision of intestine'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.631683,"However, robotic repair had longer operative duration (141  v  77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125)  v  $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004).","[{'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Olavarria', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA oscarolavarria@hotmail.com.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bernardi', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Shinil K', 'Initials': 'SK', 'LastName': 'Shah', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Wilson', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Shuyan', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX, USA.'}, {'ForeName': 'Elenir B', 'Initials': 'EB', 'LastName': 'Avritscher', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX, USA.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Loor', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Tien C', 'Initials': 'TC', 'LastName': 'Ko', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m2457']
166,32660329,Introducing a forced choice recognition trial to the Hopkins Verbal Learning Test - Revised.,"OBJECTIVE


This study was designed to replicate previous research on embedded validity indicators (EVIs) in the Hopkins Verbal Learning Test - Revised (HVLT-R) and introduce a new forced choice recognition trial (FCR).
METHOD


Undergraduate research volunteers were randomly assigned ( M Age  = 21.7;  M Education  = 14.5 years, 85% female) to either the control or experimental malingering condition, and were administered a brief battery of neuropsychological tests.
RESULTS


Recognition memory based EVIs (both existing and newly introduced) effectively discriminated credible and non-credible response sets. An FCR ≤11 produced .59 sensitivity and perfect specificity to invalid responding. A Recognition Discrimination (RD) score ≤8 also produced a good combination of sensitivity (.35) and specificity (.96). The FCR trial made unique contributions to performance validity assessment above and beyond previously published EVIs.
CONCLUSIONS


RD achieved ≥.90 specificity at higher cutoffs than previously reported. The newly introduced FCR trial has the potential to enhance the existing arsenal of EVIs within the HVLT-R. However, it must demonstrate its ability to differentiate genuine impairment from non-credible responding before it can be recommended for clinical use.",2021,"RESULTS


Recognition memory based EVIs (both existing and newly introduced) effectively discriminated credible and non-credible response sets.","['Undergraduate research volunteers were randomly assigned ( M   Age  = 21.7;  M   Education  = 14.5\u2009years, 85% female) to either the']","['control or experimental malingering condition', 'Hopkins Verbal Learning Test - Revised (HVLT-R']",['A Recognition Discrimination (RD) score'],"[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191366', 'cui_str': '21.7'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024630', 'cui_str': 'Malingering'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0297511,"RESULTS


Recognition memory based EVIs (both existing and newly introduced) effectively discriminated credible and non-credible response sets.","[{'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Abeare', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Hurtubise', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cutler', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sirianni', 'Affiliation': 'School of Social Work, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Maame', 'Initials': 'M', 'LastName': 'Brantuo', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Nadeen', 'Initials': 'N', 'LastName': 'Makhzoum', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Laszlo A', 'Initials': 'LA', 'LastName': 'Erdodi', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}]",The Clinical neuropsychologist,['10.1080/13854046.2020.1779348']
167,33083016,Gut microbiota patterns associated with somatostatin in patients undergoing pancreaticoduodenectomy: a prospective study.,"Postoperative pancreatic fistula (POPF) is a common and dreaded complication after pancreaticoduodenectomy (PD). The gut microbiota has been considered as an crucial mediator of postoperative complications, however, the precise roles of gut microbiota in POPF are unclear. A prospective study was developed to explore the effects of somatostatin on gut microbiota and we aim to identify the microbial alterations in the process of POPF. A total of 45 patients were randomly divided into PD group or additional somatostatin therapy group. The fecal sample of each patient was collected preoperatively and postoperatively and the gut microbiota was analyzed by 16S rRNA sequencing. Our study found that somatostatin therapy was independent risk factor for the occurrence of POPF, and it reduced the microbial diversity and richness in patients. At genus level, somatostatin therapy led to a decreased abundance in Bifidobacterium, Subdoligranulum and Dubosiella, whereas the abundance of Akkermansia, Enterococcus and Enterobacter were increased. The abundance levels of certain bacteria in the gut microbiota have significantly shifted in patients with POPF. The LEfSe analysis revealed that Ruminococcaceae could be used as microbial markers for distinguishing patients with high risk of POPF. Furthermore, Verrucomicrobia and Akkermansia could be used as preoperative biomarkers for identifying patients without POPF. Our prospective study highlights the specific communities related with somatostatin therapy and discovers POPF-associated microbial marker, which suggests that gut microbiota may become a diagnostic biomarker and potential therapeutic target for POPF.",2020,"At genus level, somatostatin therapy led to a decreased abundance in Bifidobacterium, Subdoligranulum and Dubosiella, whereas the abundance of Akkermansia, Enterococcus and Enterobacter were increased.","['patients undergoing pancreaticoduodenectomy', 'patients with POPF', '45 patients']","['PD group or additional somatostatin therapy group', 'somatostatin', 'somatostatin therapy']","['Postoperative pancreatic fistula (POPF', 'abundance in Bifidobacterium, Subdoligranulum and Dubosiella, whereas the abundance of Akkermansia, Enterococcus and Enterobacter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037659', 'cui_str': 'Somatostatin'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1503440', 'cui_str': 'Subdoligranulum'}, {'cui': 'C1490589', 'cui_str': 'Akkermansia'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}, {'cui': 'C0014344', 'cui_str': 'Enterobacter'}]",45.0,0.0160419,"At genus level, somatostatin therapy led to a decreased abundance in Bifidobacterium, Subdoligranulum and Dubosiella, whereas the abundance of Akkermansia, Enterococcus and Enterobacter were increased.","[{'ForeName': 'Guan-Qun', 'Initials': 'GQ', 'LastName': 'Li', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Wei-Guang', 'Initials': 'WG', 'LastName': 'Yang', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Hao-Liang', 'Initials': 'HL', 'LastName': 'Zhong', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xiao', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Li-Wei', 'Initials': 'LW', 'LastName': 'Liu', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Yong-Wei', 'Initials': 'YW', 'LastName': 'Wang', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Kong', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Hong-Tao', 'Initials': 'HT', 'LastName': 'Tan', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Xue-Wei', 'Initials': 'XW', 'LastName': 'Bai', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Li', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}]",Cell death discovery,['10.1038/s41420-020-00329-4']
168,32682793,New Ultrasonic Tip Decreases Uninstrumented Surface and Debris in Flattened Canals: A Micro-computed Tomographic Study.,"INTRODUCTION


The preparation of flattened root canals using reciprocating or rotary nickel-titanium instruments associated with the Flatsonic ultrasonic tip (Helse Ultrasonic, Santa Rosa de Viterbo, SP, Brazil) was evaluated by micro-computed tomographic imaging.
METHODS


Twenty-four flattened distal canals of mandibular molars with a buccolingual diameter 4 or more times larger than the mesiodistal diameter were selected. The root canals were randomly divided into 2 experimental groups for preparation: a Reciproc Blue (RB; VDW GmbH, Munich, Germany) 40/.06 file in reciprocating motion or ProDesign Logic (PDL; Easy Equipamentos Odontológicos, Belo Horizonte, MG, Brazil) 40/.01 and 40/.05 files in rotary motion (n = 12). A complementary preparation was performed with the Flatsonic ultrasonic tip for both preparations. Micro-computed tomographic scanning at a resolution of 8.74 μm was performed before and after preparation with the nickel-titanium instruments and after the use of the Flatsonic tip. The percentages of increase in volume, debris, and uninstrumented surface were analyzed. The data obtained were submitted to the paired and unpaired t test, analysis of variance, and the Tukey test (α = 5%).
RESULTS


The percentage increase in volume, debris, and uninstrumented surface was similar between RB and PDL in the entire root canal (P > .05). The PDL promoted a lower percentage of debris in the cervical third and a lower percentage of increase in volume in the apical third in comparison with RB (P < .05). The Flatsonic decreased debris and uninstrumented surface after PDL preparation in all thirds (P < .05). After preparation with RB, the Flatsonic decreases the debris in the cervical third and the uninstrumented surface in the cervical and middle thirds (P < .05).
CONCLUSIONS


The preparation of flattened root canals using RB or PDL produced a high percentage of debris and uninstrumented surface. The Flatsonic ultrasonic tip significantly improved the cleaning of flattened root canals.",2020,Flatsonic decreased debris and uninstrumented surface after PDL preparation in all thirds (P < .05).,['Twenty-four flattened distal canals of mandibular molars with a buccolingual diameter 4 or more times larger than the mesiodistal diameter were selected'],"['preparation: Reciproc Blue (RB', 'PDL', 'Micro-CT scanning', 'New ultrasonic tip', 'flattened root canals using reciprocating or rotary nickel-titanium (NiTi']","['Flatsonic decreased debris and uninstrumented surface', 'volume, debris and uninstrumented surface', 'Flatsonic ultrasonic tip']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0023963', 'cui_str': 'Logic'}, {'cui': 'C2350281', 'cui_str': 'MicroCT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]",24.0,0.014489,Flatsonic decreased debris and uninstrumented surface after PDL preparation in all thirds (P < .05).,"[{'ForeName': 'Airton Oliveira', 'Initials': 'AO', 'LastName': 'Santos-Junior', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Tanomaru-Filho', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil. Electronic address: tanomaru@uol.com.br.'}, {'ForeName': 'Jader Camilo', 'Initials': 'JC', 'LastName': 'Pinto', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Karina Ines Medina Carita', 'Initials': 'KIMC', 'LastName': 'Tavares', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Mariana Mena Barreto', 'Initials': 'MMB', 'LastName': 'Pivoto-João', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Juliane Maria', 'Initials': 'JM', 'LastName': 'Guerreiro-Tanomaru', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil.'}]",Journal of endodontics,['10.1016/j.joen.2020.07.012']
169,33079379,Thromboprophylaxis for patients with newly diagnosed vs. recurrent cancers: a post-hoc analysis of the avert trial.,"Venous thromboembolic disease (VTE) is a common complication among patients with cancer. Data reporting risk of VTE among patients receiving chemotherapy for recurrent cancer compared to those with newly diagnosed tumors is scarce. Furthermore, it is unclear if thromboprophylaxis is beneficial and safe in these specific patient populations. Post-hoc analysis of the AVERT trial which was a randomized, placebo-controlled, double-blind trial comparing apixaban therapy to placebo for VTE prophylaxis among cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy. The HRs for recurrent VTE and major bleeding episodes in patients with newly diagnosed and recurrent cancers were calculated using a Cox regression model controlling for age, gender, and center. Of the 563 included patients 469 and 93 patients had newly diagnosed and recurrent cancers, respectively. Patients with recurrent cancer have a higher risk of VTE (Hazard ratio (HR): 1.53 (95% CI 1.0 to 2.33; p = 0.047) and major bleeding episodes (HR 2.89 (95% CI 1.52 to 5.49; p = 0.001) compared to those with newly diagnosed cancer. In patients with newly diagnosed cancers, the use of apixaban was associated with a significantly lower risk of VTE (HR 0.45; 95% CI 0.27-0.76; p = 0.002) and a higher rate of major bleeding (HR 2.10; 95% CI 1.09-4.08; p = 0.028). In patients with recurrent cancer, apixaban was associated with a significant lower rate of VTE (HR 0.26; 95% CI 0.13-0.53; p < 0.001) without an associated significantly increased risk of major bleeding (HR 1.82; 95% CI 0.36-9.15; p = 0.466). Patients with recurrent cancer seem to be at higher risk of recurrent VTE and major bleeding complications compared to those with newly diagnosed tumors. Apixaban appears to be safe and effective in these patient populations.",2021,Patients with recurrent cancer have a higher risk of VTE (Hazard ratio (HR): 1.53 (95% CI 1.0 to 2.33; p = 0.047) and major bleeding episodes (HR 2.89 (95% CI 1.52 to 5.49; p = 0.001) compared to those with newly diagnosed cancer.,"['patients receiving', 'patients with newly diagnosed and recurrent cancers', 'Patients with recurrent cancer', 'patients with newly diagnosed vs. recurrent cancers', '563 included patients 469 and 93 patients had newly diagnosed and recurrent cancers, respectively', 'cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy', 'patients with cancer']","['Apixaban', 'Thromboprophylaxis', 'placebo', 'apixaban therapy to placebo', 'chemotherapy']","['HRs for recurrent VTE and major bleeding episodes', 'major bleeding episodes', 'rate of major bleeding', 'rate of VTE', 'risk of major bleeding', 'recurrent VTE and major bleeding complications', 'risk of VTE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0549379', 'cui_str': 'Recurrent cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",563.0,0.283821,Patients with recurrent cancer have a higher risk of VTE (Hazard ratio (HR): 1.53 (95% CI 1.0 to 2.33; p = 0.047) and major bleeding episodes (HR 2.89 (95% CI 1.52 to 5.49; p = 0.001) compared to those with newly diagnosed cancer.,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institut du Savoir Montfort, Montfort Hospital, Ottawa, Canada.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Atalla', 'Affiliation': 'Department of Medicine, University of Ottawa, the Ottawa Hospital Research Institute, 501 Smyth Road, Box 201 a, Ottawa, ON, K1H 8L6, Canada.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Ottawa, the Ottawa Hospital Research Institute, 501 Smyth Road, Box 201 a, Ottawa, ON, K1H 8L6, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine, University of Ottawa, the Ottawa Hospital Research Institute, 501 Smyth Road, Box 201 a, Ottawa, ON, K1H 8L6, Canada. mcarrier@toh.ca.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02317-y']
170,33069623,Longitudinal Evaluation of Perineogenital Pain and Postoperative Complications After One-stage Buccal Mucosal Graft Urethroplasty: A Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


Little is known about patient-reported intensity and quality of pain at the receiver site as well as postoperative complications following one-stage buccal mucosal graft urethroplasty (BMGU).
OBJECTIVE


To evaluate perineogenital pain intensity and quality as well as short-term complications after BMGU, and to describe the impact of pain and complications on stricture recurrence.
DESIGN, SETTING, AND PARTICIPANTS


A secondary analysis of a randomized controlled trial including 135 patients, who underwent BMGU from 2014 to 2015, was performed.
INTERVENTION


One-stage BMGU.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Patient-reported perineogenital pain was assessed by the Numeric Pain Rating Scale and the Short-form McGill Pain Questionnaire preoperatively and at 1, 5, and 21 d, and 3, 6, and 12 mo postoperatively. Complications were assessed by the Clavien-Dindo classification and the Comprehensive Complication Index. Pain and complications were compared according to stricture recurrence.
RESULTS AND LIMITATIONS


At a mean follow-up of 21±15 mo, 29 patients (21%) had stricture recurrence. Pain intensity as well as sensory and affective pain quality decreased over time, reaching a minimum at 6 mo. Postoperative complications at days 5 (95% of patients) and 21 (27% of patients) were predominantly ""minor"" (Clavien-Dindo classification grade≤IIIa). Neither patient-reported perineogenital pain nor cumulative morbidity burden was different between patients with and those without stricture recurrence (all p ≥ 0.05).
CONCLUSIONS


Perineogenital pain is frequent after BMGU, but pain intensity and quality decrease over time. The same holds true for postoperative complications, which are frequent but mostly present as minor events. Current findings allow for thorough preoperative patient counseling regarding the expected perineogenital pain intensity and quality over time as well as complications following BMGU.
PATIENT SUMMARY


In this study, we looked at pain intensity and pain quality as well as complications following buccal mucosal graft urethroplasty. We found that pain in the perineogenital region is frequent, but pain intensity and quality decrease over time. Similarly, postoperative complications are frequent, but mainly present as minor events.",2021,"Neither patient-reported perineogenital pain nor cumulative morbidity burden was different between patients with and those without stricture recurrence (all p ≥ 0.05).
","['135 patients, who underwent BMGU from 2014 to 2015, was performed', 'After One-stage Buccal Mucosal Graft Urethroplasty']",[],"['Pain intensity as well as sensory and affective pain quality', 'Clavien-Dindo classification and the Comprehensive Complication Index', 'Perineogenital Pain and Postoperative Complications', 'postoperative complications', 'Postoperative complications', 'Complications', 'Pain and complications', 'pain intensity and pain quality', 'perineogenital pain intensity and quality', 'perineogenital pain', 'stricture recurrence', 'perineogenital pain nor cumulative morbidity burden', 'pain intensity and quality decrease over time', 'Numeric Pain Rating Scale and the Short-form McGill Pain Questionnaire']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0450135', 'cui_str': 'Mucosal graft'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",[],"[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}]",135.0,0.180189,"Neither patient-reported perineogenital pain nor cumulative morbidity burden was different between patients with and those without stricture recurrence (all p ≥ 0.05).
","[{'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Fuehner', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Malte W', 'Initials': 'MW', 'LastName': 'Vetterlein', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Lesske', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rink', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Riechardt', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'König', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Gild', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans O', 'Initials': 'HO', 'LastName': 'Pinnschmidt', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Meyer', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ludwig', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Engel', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Fisch', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Dahlem', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Soave', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: a.soave@uke.de.'}]",European urology focus,['10.1016/j.euf.2020.09.018']
171,32673591,Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity.,"Time-restricted feeding (TRF) regimens have grown in popularity; however, very few studies have examined their weight-loss efficacy. We conducted the first human trial (Clinicaltrials.gov NCT03867773) to compare the effects of two popular forms of TRF (4 and 6 h) on body weight and cardiometabolic risk factors. Adults with obesity were randomized to 4-h TRF (eating only between 3 and 7 p.m.), 6-h TRF (eating only between 1 and 7 p.m.), or a control group (no meal timing restrictions). After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls. Energy intake was reduced by ∼550 kcal/day in both TRF groups, without calorie counting. These findings suggest that 4- and 6-h TRF induce mild reductions in body weight over 8 weeks and show promise as interventions for weight loss. These diets may also improve some aspects of cardiometabolic health.",2020,"After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls.","['Adults with Obesity', 'Adults with obesity']","['4-h TRF', 'TRF', '4- and 6-h Time-Restricted Feeding', 'control group (no meal timing restrictions']","['body weight (∼3%), insulin resistance, and oxidative stress', 'body weight', 'Energy intake', 'Weight and Cardiometabolic Health', 'body weight and cardiometabolic risk factors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",,0.0381324,"After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Cienfuegos', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Gabel', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Kalam', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ezpeleta', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wiseman', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Pavlou', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Shuhao', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Manoela Lima', 'Initials': 'ML', 'LastName': 'Oliveira', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Krista A', 'Initials': 'KA', 'LastName': 'Varady', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA. Electronic address: varady@uic.edu.'}]",Cell metabolism,['10.1016/j.cmet.2020.06.018']
172,33071178,Effect of surgical versus medical therapy on estimated cardiovascular event risk among adolescents with type 2 diabetes and severe obesity.,"BACKGROUND


Cardiovascular disease (CVD) remains the leading cause of mortality in type 2 diabetes (T2D). Better interventions are needed to mitigate the high lifetime risk for CVD in youth T2D.
OBJECTIVE


To compare 30-year risk for CVD events in 2 cohorts of adolescents with T2D and severe obesity undergoing medical or surgical treatment of T2D.
SETTING


Longitudinal multicenter studies at University hospitals.
METHODS


A secondary analysis of data collected from the participants with T2D enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS, n = 30) and participants of similar age and racial distribution from the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY, n = 63) studies was performed. Teen-LABS participants underwent metabolic bariatric surgery (MBS). TODAY participants were randomized to metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy given for glycemic progression. A 30-year CVD event score developed by the Framingham Heart Study was the primary outcome, assessed at baseline (preoperatively for Teen-LABS), 1 year, and 5 years of follow-up.
RESULTS


Participants with T2D from Teen-LABS (n = 30; mean ± SD age = 16.9 ± 1.3 yr; 70% female; 60% white; body mass index (BMI) = 54.4 ± 9.5 kg/m 2 ) and TODAY (n = 63; 15.3 ± 1.3 yr; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ) were compared. The likelihood of CVD events was higher in Teen-LABS versus TODAY at baseline (17.66 [1.59] versus 12.11 [.79]%, adjusted P = .002). One year after MBS, event risk was significantly lower in Teen-LABS versus TODAY (6.79 [1.33] versus 13.64 [0.96]%, adjusted P < .0001), and sustained at 5 years follow-up (adjusted P < .0001).
CONCLUSION


Despite higher pretreatment risk for CVD events, treatment with MBS resulted in a reduction in estimated CVD event risks, whereas medical therapy associated with an increase in risk among adolescents with T2D and severe obesity.",2021,"The likelihood of CVD events was higher in Teen-LABS versus TODAY at baseline (17.66 [1.59] versus 12.11 [.79]%, adjusted P = .002).","['adolescents with type 2 diabetes and severe obesity', 'participants with T2D enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS, n = 30) and participants of similar age and racial distribution from the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY, n = 63) studies was performed', 'adolescents with T2D and severe obesity', '2 cohorts of adolescents with T2D and severe obesity undergoing medical or surgical treatment of T2D.\nSETTING\n\n\nLongitudinal multicenter studies at University hospitals', 'Participants with T2D from Teen-LABS (n = 30; mean ± SD age = 16.9 ± 1.3 yr; 70% female; 60% white; body mass index (BMI) = 54.4 ± 9.5 kg/m 2 ) and TODAY (n = 63; 15.3 ± 1.3 yr; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ']","['metabolic bariatric surgery (MBS', 'surgical versus medical therapy', 'MBS', 'metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy']","['likelihood of CVD events', 'estimated CVD event risks', 'risk', 'event risk']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C4517578', 'cui_str': '15.3'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0954744,"The likelihood of CVD events was higher in Teen-LABS versus TODAY at baseline (17.66 [1.59] versus 12.11 [.79]%, adjusted P = .002).","[{'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ryder', 'Affiliation': 'University of Minnesota Medical School and Center for Pediatric Obesity Medicine, Minneapolis, Minnesota, United States.'}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, Ohio, United States.""}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, United States.""}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Kelsey', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, United States.""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, Ohio, United States.""}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, Ohio, United States.""}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Inge', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, United States.""}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, United States. Electronic address: petter.bjornstad@childrenscolorado.org.""}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.09.002']
173,33083852,Effect of Lactobacillus brevis CD2 containing lozenges and plaque pH and cariogenic bacteria in diabetic children: a randomised clinical trial.,"OBJECTIVE


The short-term effect (60 days) of Lactobacillus brevis CD2 lozenges vs placebo on variables related to caries and gingivitis in type 1 diabetic children was evaluated.
MATERIAL AND METHODS


Eight diabetics (4-14 years old) were assigned to two groups (n = 34 subjects each), probiotic lozenges and placebo. Stimulated saliva for microbiological analysis and plaque pH were assessed at baseline (t 0 ), 30 days (t 1 ), 60 days (t 2 ) and in the follow-up period (90 days from baseline, t 3 ). Gingival status was assessed at t 0 , t 2  and t 3 . Two-way ANOVA assessed differences between groups.
RESULTS


In the probiotic group, Streptococcus mutans bacterial density mean scores dropped from 3.11 ± 1.13 at baseline to 1.82 ± 0.72 (t 2 ) and to 2.06 ± 0.56 (t 3 ), while in the placebo group, the scores were 3.09 ± 0.8 (t 0 ), 2.82 ± 0.47 (t 2 ) and 3.11 ± 0.43 (t 3 ) (p < 0.01). Lowest and maximum pH fall increased in the probiotic group, from 5.37 ± 0.41 at baseline to 5.49 ± 0.24 at t 3  (p < 0.01) and from 1.20 ± 0.46 to 0.98 ± 0.29 (p = 0.02). Bleeding score decreased significantly in both groups, showing a statistically significant lower bleeding score at t 2  in the probiotic group (25.6%, 95% CI 21.5-32.7 vs 29.5%, 95% CI 25.2-34.9, p = 0.02).
CONCLUSIONS


Lactobacillus brevis CD2 has shown to improve caries-related risk factors and gingival health in diabetic children.
CLINICAL RELEVANCE


Lactobacillus brevis CD2 might contribute to improved oral health in type 1 diabetic children.",2021,"In the probiotic group, Streptococcus mutans bacterial density mean scores dropped from 3.11 ± 1.13 at baseline to 1.82 ± 0.72 (t 2 ) and to 2.06 ± 0.56 (t 3 ), while in the placebo group, the scores were 3.09 ± 0.8 (t 0 ), 2.82 ± 0.47 (t 2 ) and 3.11 ± 0.43 (t 3 ) (p < 0.01).","['type 1 diabetic children', 'Eight diabetics (4-14 years old', 'diabetic children']","['Lactobacillus brevis CD2 lozenges vs placebo', 'Lactobacillus brevis CD2 containing lozenges and plaque pH and cariogenic bacteria', 'Lactobacillus brevis CD2', 'probiotic lozenges and placebo', 'Lactobacillus']","['Bleeding score', 'Streptococcus mutans bacterial density mean scores', 'Gingival status', 'Stimulated saliva for microbiological analysis and plaque pH', 'maximum pH fall', 'bleeding score', 'oral health']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0425067', 'cui_str': 'Diabetic child'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0317604', 'cui_str': 'Lactobacillus brevis'}, {'cui': 'C0108773', 'cui_str': 'Lymphocyte antigen CD2'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.186119,"In the probiotic group, Streptococcus mutans bacterial density mean scores dropped from 3.11 ± 1.13 at baseline to 1.82 ± 0.72 (t 2 ) and to 2.06 ± 0.56 (t 3 ), while in the placebo group, the scores were 3.09 ± 0.8 (t 0 ), 2.82 ± 0.47 (t 2 ) and 3.11 ± 0.43 (t 3 ) (p < 0.01).","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Department of Biomedical Sciences-Medical School, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lingström', 'Affiliation': 'Department of Cariology, Institute of Odontology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Cagetti', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Cocco', 'Affiliation': 'Department of Surgery, Medical and Experimental Sciences, University of Sassari, Sassari, Italy. fcocco@uniss.it.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Meloni', 'Affiliation': 'Department of Surgery, Medical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Maria Antonietta', 'Initials': 'MA', 'LastName': 'Arrica', 'Affiliation': 'Department of Surgery, Medical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Guglielmo', 'Initials': 'G', 'LastName': 'Campus', 'Affiliation': 'Department of Surgery, Medical and Experimental Sciences, University of Sassari, Sassari, Italy.'}]",Clinical oral investigations,['10.1007/s00784-020-03342-0']
174,33070582,Endotracheal intubation in patients undergoing open abdominal surgery in the lateral position: a comparison between the intubating video stylet and fiberoptic intubating bronchoscopy.,"BACKGROUND


Some situations compel anesthetists to execute endotracheal intubation in the lateral position. We compared elective endotracheal intubation in the lateral decubitus position using the video stylet (VS) device with the fiberoptic (FO) bronchoscope device in patients undergoing abdominal surgery.
METHODS


Overall, 50 patients were enrolled in this prospective, randomized study. They were randomly classified into the VS intubation or FO intubating bronchoscope group. After anesthesia induction, patients were placed in the lateral decubitus position, and a single investigator well-versed with the use of the VS and FO bronchoscope performed the intubation. The primary outcome was the time taken for intubation. Secondary outcomes included the intubation success rate, hemodynamic response at specific time points and perioperative complications.
RESULTS


The average time taken for intubation was significantly lesser in the VS group than in the FO group, with values of 39.5 ± 10.0 and 75.6 ± 16.2 s, respectively (P < 0.001). Incidences of a successful first attempt of intubation in the VS and FO groups were 88% and 100%, respectively, showing no significant difference. There was a negligible difference in complications between the groups, except sore throat, which showed a higher incidence in the VS group than in the FO group (P = 0.002).
CONCLUSIONS


In laterally positioned patients, elective endotracheal intubation with VS provides less intubation time; however, its use is accompanied by a significant increase in the hemodynamic response after intubation and an increased incidence of sore throat.",2021,"There was a negligible difference in complications between the groups except sore throat, which showed a higher incidence in the VS group than that in the FO group (P = 0.013).
","['50 patients', 'patients undergoing open abdominal surgery in the lateral position', 'patients undergoing laparotomy abdominal surgery']","['intubating video stylet and fiberoptic intubating bronchoscopy', 'video stylet device with fiberoptic bronchoscope device', 'elective endotracheal intubation', 'Endotracheal intubation', 'video stylet (VS) intubation group or fiberoptic (FO) intubating bronchoscope group']","['intubation success rate, hemodynamic response at specific time points, overall user satisfaction and perioperative complications', 'time taken for intubation', 'intubation time and incidence of success rate', 'Incidence of successful first attempt intubation', 'average time taken for intubation', 'complications', 'hemodynamic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179432', 'cui_str': 'Bronchoscope'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.137646,"There was a negligible difference in complications between the groups except sore throat, which showed a higher incidence in the VS group than that in the FO group (P = 0.013).
","[{'ForeName': 'Amr Samir', 'Initials': 'AS', 'LastName': 'Wahdan', 'Affiliation': 'Department of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nesrine Abdel Rahman', 'Initials': 'NAR', 'LastName': 'El-Refai', 'Affiliation': 'Department of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sohaila Hussien', 'Initials': 'SH', 'LastName': 'Omar', 'Affiliation': 'Department of Anesthesia, Surgical ICU and Pain Management, Theodor Bilharz Research Institute, Cairo, Egypt.'}, {'ForeName': 'Shady Amr', 'Initials': 'SA', 'LastName': 'Abdel Moneem', 'Affiliation': 'Department of Anesthesia, Surgical ICU and Pain Management, Theodor Bilharz Research Institute, Cairo, Egypt.'}, {'ForeName': 'Mennatallah Magdi', 'Initials': 'MM', 'LastName': 'Mohamed', 'Affiliation': 'Department of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Mahmoud', 'Initials': 'MM', 'LastName': 'Hussien', 'Affiliation': 'Department of Anesthesia, Surgical ICU and Pain Management, Theodor Bilharz Research Institute, Cairo, Egypt.'}]",Korean journal of anesthesiology,['10.4097/kja.20384']
175,33092897,Effect of Wii-habilitation on spatiotemporal parameters and upper limb function post-burn in children.,"BACKGROUND


Limb burns can cause different functional disorders that greatly impact one's quality of life.
AIM


The purpose of the current study was to compare the effect of Nintendo Wii sports intervention, and traditional treatment methods on spatiotemporal parameters and upper limb function post-burn in children.
METHODS


Thirty children their age ranging from 7-12 years, with dominant side upper limb burn participated in the study.Vicon3-D motion analysis system and Jebsen hand function test were used to evaluate spatiotemporal parameters (movement duration, peak velocity, and time to peak velocity percentage in three functional tasks) and upper limb function respectively. The children were randomly divided into study and control groups. The study group was rehabilitated with Wii training in addition to traditional therapy, while the control group rehabilitated only with the traditional therapy program. For the study group, the games selected were Wii Bowling, Baseball, and Tennis. Both groups were trained for 60 min daily, three times/week for six weeks. The outcomes were measured pre and post the treatment period.
RESULTS


The whole-time duration and peak velocity improved significantly in the study group across the hand to head task (p = 0.001, p < 0.001, respectively), hand to mouth (p = 0.001), and hand to shoulder (p < 0.001, p = 0.0018, respectively) compared with the control group. The time to peak velocity percentage was enhanced significantly in the study group (p < 0.001) than the control group in all three-measured tasks. Moreover, the Jebsen hand function test improved significantly (p < 0.001) in the study group than in the control group.
CONCLUSION


Wii-habilitation could be advised as an effective tool in the rehabilitation program of children with post-burn injuries.",2021,"Moreover, the Jebsen hand function test improved significantly (p < 0.001) in the study group than in the control group.
","['children', 'children with post-burn injuries', 'Thirty children their age ranging from 7-12 years, with dominant side upper limb burn participated in the study']","['Nintendo Wii sports intervention', 'Wii training in addition to traditional therapy, while the control group rehabilitated only with the traditional therapy program', 'Wii-habilitation']","['spatiotemporal parameters (movement duration, peak velocity, and time to peak velocity percentage in three functional tasks) and upper limb function respectively', 'whole-time duration and peak velocity', 'Jebsen hand function test', 'time to peak velocity percentage']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445480', 'cui_str': 'Dominant side'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018459', 'cui_str': 'Habilitation'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451237', 'cui_str': 'Jebsen hand function test'}]",30.0,0.028214,"Moreover, the Jebsen hand function test improved significantly (p < 0.001) in the study group than in the control group.
","[{'ForeName': 'Nadia L', 'Initials': 'NL', 'LastName': 'Radwan', 'Affiliation': 'Department of Biomechanics, Faculty of Physical Therapy, Cairo University, Egypt; Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Kingdom of Saudi Arabia. Electronic address: nadiaradwan18@yahoo.com.'}, {'ForeName': 'Marwa M', 'Initials': 'MM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Egypt; Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Kingdom of Saudi Arabia.'}, {'ForeName': 'Waleed S', 'Initials': 'WS', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Kingdom of Saudi Arabia; Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.09.010']
176,33098278,Counselor Surveillance of Digital Self-Monitoring Data: A Pilot Randomized Controlled Trial.,"OBJECTIVE


This pilot study tested counselor access to participants' digital self-monitoring (SM) data as a means of improving long-term lifestyle modification (LM) outcomes.
METHODS


After 12 weeks of weight-loss treatment, participants (N = 77) were randomized to LM or LM+SHARE for weeks 13 to 52. All participants received monthly phone calls and weekly text messages from weeks 13 to 52 and were instructed to engage in daily digital SM of weight, eating, and exercise. In LM+SHARE, but not LM, counselors had access to SM device data. Assessments were conducted as weeks 0, 13, 26, and 52.
RESULTS


Retention, engagement, and treatment satisfaction were excellent. LM+SHARE participants, compared with LM, had more frequent SM of weight and eating. Weight loss continued at a similar rate in both conditions from weeks 13 to 26. From weeks 26 to 52, those in LM regained approximately 2 kg, whereas those in LM+SHARE maintained weight loss, a significant difference. Nonetheless, total weight loss did not significantly differ by condition. Engagement in dietary SM mediated the effect of condition on weight.
CONCLUSIONS


Counselor access to SM data is feasible and acceptable. Additional research is warranted to determine whether it can meaningfully improve outcomes.",2020,"Nonetheless, total weight loss did not significantly differ by condition.","['participants (N\u2009=\u200977', 'participants']","['Digital Self-Monitoring Data', 'monthly phone calls and weekly text messages from weeks 13 to 52 and were instructed to engage in daily digital SM of weight, eating, and exercise', 'digital self-monitoring (SM) data', 'LM or LM+SHARE']","['Retention, engagement, and treatment satisfaction', 'frequent SM of weight and eating', 'Weight loss', 'total weight loss']",[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",77.0,0.0682005,"Nonetheless, total weight loss did not significantly differ by condition.","[{'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Martinelli', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nicole T', 'Initials': 'NT', 'LastName': 'Crane', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Godfrey', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Savannah R', 'Initials': 'SR', 'LastName': 'Roberts', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Fengqing', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23015']
177,33129705,A Randomized Controlled Trial of Music for Pain Relief after Arthroplasty Surgery.,"PURPOSE


Effective pain management for patients undergoing orthopedic surgery, using pharmacological and nonpharmacological strategies, is essential. This pilot study evaluated music as an adjuvant therapy with prescribed analgesics to reduce acute pain and analgesic use among patients undergoing arthroplasty surgery.
DESIGN


Prospective randomized controlled trial of 50 participants scheduled for arthroplasty surgery at a large university-affiliated hospital.
METHODS


Participants were randomly assigned to treatment (music and analgesic medication; n = 25) or control (analgesic medication only; n = 25) groups. The intervention consisted of listening to self-selected music for 30 minutes, three times per day postoperatively in hospital and for 2 days postdischarge at home. Participants rated pain intensity and distress before and after music listening (treatment group) or meals (control group). Analgesic medication use was assessed via medical records in hospital and self-report logs postdischarge.
RESULTS


Forty-seven participants completed the study. Participants who listened to music after surgery reported significantly lower pain intensity and distress in hospital and postdischarge at home. There were no statistically significant differences in analgesic medication use after surgery between groups.
CONCLUSIONS


Study findings provide further evidence for the effectiveness of music listening, combined with analgesics, for reducing postsurgical pain, and extend the literature by examining music listening postdischarge. Music listening is an effective adjuvant pain management strategy. It is easy to administer, accessible, and affordable. Patient education is needed to encourage patients to continue to use music to reduce pain at home during the postoperative recovery period.",2021,Participants who listened to music after surgery reported significantly lower pain intensity and distress in hospital and postdischarge at home.,"['50 participants scheduled for arthroplasty surgery at a large university-affiliated hospital', 'patients undergoing orthopedic surgery', 'patients undergoing arthroplasty surgery', 'Participants', 'after Arthroplasty Surgery', 'Forty-seven participants completed the study']","['Music', 'Music listening', 'treatment (music and analgesic medication; n\xa0=\xa025) or control (analgesic medication only; n\xa0=\xa025) groups', 'music listening (treatment group) or meals (control group']","['pain intensity and distress', 'analgesic medication', 'Pain Relief', 'pain intensity and distress in hospital and postdischarge at home']","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",50.0,0.294345,Participants who listened to music after surgery reported significantly lower pain intensity and distress in hospital and postdischarge at home.,"[{'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Laframboise-Otto', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, Florida. Electronic address: lafrajm@ufl.edu.'}, {'ForeName': 'MaryBeth', 'Initials': 'M', 'LastName': 'Horodyski', 'Affiliation': 'Department of Orthopedics & Rehabilitation, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Hari K', 'Initials': 'HK', 'LastName': 'Parvataneni', 'Affiliation': 'Department of Orthopedics & Rehabilitation, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Horgas', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, Florida.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2020.09.003']
178,33105146,The Glycemic Effect of Liraglutide Evaluated by Continuous Glucose Monitoring in Persons with Type 2 Diabetes Receiving Dialysis.,"AIMS


The aim of this study was to evaluate the effect of liraglutide treatment on glucose variability and the risk of hypoglycemia by continuous glucose monitoring (CGM) in persons with type 2 diabetes (T2D) and dialysis-dependent end-stage renal disease (ESRD).
MATERIALS AND METHODS


We assessed CGM data from a previous trial where 24 persons with T2D and dialysis-dependent ESRD were allocated (1:1) to 12 weeks of double-blinded treatment with liraglutide (titrated to maximum tolerable dose up to 1.8 mg) or placebo as an add-on to preexisting antidiabetic treatment. CGM (Ipro2®; Medtronic) was performed for up to 7 days at baseline and at weeks 2, 6, and 10. A linear mixed model was used to compare the 2 study arms.
RESULTS


A CGM was worn at baseline by 12 persons in the liraglutide group and 10 in the placebo group (7 and 9 completed week 10, respectively). Glycated hemoglobin A1c (p = 0.81) and glucose variability was similar between the groups (standard deviation, p = 0.33; coefficient of variation, p = 0.16). Comparing baseline and week 10, the number of hypoglycemic events (glucose values between <3.9 and 3.0 mmol/L) increased in the liraglutide group compared with the placebo group (p = 0.02). The occurrence of hypoglycemic events below 3.0 mmol/L was similar between the groups (p = 0.36).
CONCLUSIONS


In the present cohort of persons with T2D and dialysis-dependent ESRD, liraglutide treatment increased the risk of hypoglycemic events as compared to placebo (no difference was found for hypoglycemic events below 3.0 mmol/L). The majority of participants were co-treated with insulin.",2021,"Glycated hemoglobin A1c (p = 0.81) and glucose variability was similar between the groups (standard deviation, p = 0.33; coefficient of variation, p = 0.16).","['persons with type 2 diabetes (T2D) and dialysis-dependent end-stage renal disease (ESRD', '24 persons with T2D and dialysis-dependent ESRD', 'Persons with Type 2 Diabetes Receiving Dialysis']","['continuous glucose monitoring (CGM', 'CGM (Ipro2®; Medtronic', 'insulin', 'Liraglutide Evaluated by Continuous Glucose Monitoring', 'liraglutide', 'placebo', 'liraglutide (titrated to maximum tolerable dose up to 1.8 mg) or placebo']","['Glycated hemoglobin A1c', 'glucose variability', 'risk of hypoglycemic events', 'occurrence of hypoglycemic events', 'number of hypoglycemic events (glucose values', 'glucose variability and the risk of hypoglycemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4068742', 'cui_str': '1.8'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",24.0,0.0738599,"Glycated hemoglobin A1c (p = 0.81) and glucose variability was similar between the groups (standard deviation, p = 0.33; coefficient of variation, p = 0.16).","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Bomholt', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, tobias.bomholt@regionh.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Morten B', 'Initials': 'MB', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ajenthen G', 'Initials': 'AG', 'LastName': 'Ranjan', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Marsela', 'Initials': 'M', 'LastName': 'Resuli', 'Affiliation': 'Department of Nephrology, Hillerød Hospital, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Pernille M', 'Initials': 'PM', 'LastName': 'Hansen', 'Affiliation': 'Department of Nephrology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Borg', 'Affiliation': 'Department of Nephrology, Roskilde Hospital, University of Copenhagen, Roskilde, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feldt-Rasmussen', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Hornum', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Nephron,['10.1159/000510613']
179,33121297,"Effect of polyphenol-rich extra-virgin olive oil on lipid profile and inflammatory biomarkers in patients undergoing coronary angiography: a randomised, controlled, clinical trial.","The present study was conducted to compare the effects of high polyphenol extra-virgin olive oil (EVOO) with low polyphenol refined olive oil (ROO) on some cardiovascular risk factors in patients undergoing coronary angiography. In a randomised, controlled, parallel-arm, clinical trial, 40 patients with at least one classic cardiovascular risk factor who referred to coronary angiography were randomly allocated to two groups and receied 25 mL EVOO or ROO daily for 6 weeks. Plasma LDL-cholesterol significantly reduced in EVOO group (-9.52 ± 20.44 vs 8.68 ± 18.77 mg/dL,  p  = .007 for EVOO and ROO respectively). EVOO resulted in a significant reduction in plasma CRP (-0.40 ± 0.52 vs 0.007 ± 0.42 mg/L,  p  = .01 for EVOO and ROO respectively) and increased ex-vivo whole blood LPS-stimulated IL-10 production (12.13 ± 33.64 vs -17.47 ± 49.04 pg/mL,  p  = .035 for EVOO and ROO respectively). Daily consumption of polyphenol-rich EVOO in subjects who have been under medical treatment with risk-reducing agents could additionally improve LDL-C and selected inflammatory markers.  Trial Registration Number:  NCT03796780.",2021,"EVOO resulted in a significant reduction in plasma CRP (-0.40 ± 0.52 vs 0.007 ± 0.42 mg/L,  p  = .01 for EVOO and ROO respectively) and increased ex-vivo whole blood LPS-stimulated IL-10 production (12.13 ± 33.64 vs -17.47 ± 49.04 pg/mL,  p  = .035 for EVOO and ROO respectively).","['patients undergoing coronary angiography', 'subjects who have been under medical treatment with risk-reducing agents could additionally improve LDL-C and selected inflammatory markers', '40 patients with at least one classic cardiovascular risk factor who referred to coronary angiography']","['high polyphenol extra-virgin olive oil (EVOO) with low polyphenol refined olive oil (ROO', 'polyphenol-rich extra-virgin olive oil', 'polyphenol-rich EVOO']","['cardiovascular risk factors', 'Plasma LDL-cholesterol', 'plasma CRP', 'lipid profile and inflammatory biomarkers', 'ex-vivo whole blood LPS-stimulated IL-10 production']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376446', 'cui_str': 'Reductants'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",40.0,0.252296,"EVOO resulted in a significant reduction in plasma CRP (-0.40 ± 0.52 vs 0.007 ± 0.42 mg/L,  p  = .01 for EVOO and ROO respectively) and increased ex-vivo whole blood LPS-stimulated IL-10 production (12.13 ± 33.64 vs -17.47 ± 49.04 pg/mL,  p  = .035 for EVOO and ROO respectively).","[{'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Khandouzi', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition, and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zahedmehr', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Nasrollahzadeh', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition, and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2020.1841123']
180,33105418,Assessment of High Flow Nasal Cannula Oxygenation in Endobronchial Ultrasound Bronchoscopy: A Randomized Controlled Trial.,"BACKGROUND


Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has been widely implemented in evaluating mediastinal disease. EBUS-TBNA is performed with low flow oxygen systems or general anesthesia. Little data exist on use of high flow nasal cannula (HFNC) in EBUS-TBNA.
METHODS


This was a single center parallel group randomized controlled trial comparing oxygenation through HFNC (Optiflow) against nasal prongs during EBUS. The primary end-point was the drop in oxygen saturations from procedure commencement, recorded by pulse oximetry, to the lowest level during EBUS-TBNA. Secondary end-points included changes in venous blood carbon dioxide, lowest oxygen saturation, changes in end-tidal CO2 during the procedure, intubation within 8 hours of the procedure and patient experience reported on a visual analog scale.
RESULTS


We randomized 20 patients to each study arm. The primary outcome of oxygen desaturation during the procedure was statistically significant with a difference of 7.7 percentage points (95% confidence interval, 4.91-10.49, P<0.001). The secondary outcome measure of lowest oxygen saturation was also statistically significant with a difference of -9.2 (95% confidence interval, -11.96 to -6.44, P<0.001). There was no difference in safety outcomes, visual analog scale score or in their willingness to return for repeat procedure.
CONCLUSION


This single institution study in a university, tertiary referral center confirms that EBUS-TBNA performed with HFNC is associated with a statistically significant lower drop in oxygen saturation. Additional studies are needed to assess if this translates into improved clinical outcomes postprocedure.",2021,"There was no difference in safety outcomes, visual analog scale score or in their willingness to return for repeat procedure.
",['Endobronchial Ultrasound Bronchoscopy'],"['oxygenation through HFNC (Optiflow', 'Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA', 'High Flow Nasal Cannula Oxygenation', 'high flow nasal cannula (HFNC']","['drop in oxygen saturations', 'oxygen saturation', 'safety outcomes, visual analog scale score', 'lowest oxygen saturation', 'oxygen desaturation', 'changes in venous blood carbon dioxide, lowest oxygen saturation, changes in end-tidal CO2 during the procedure, intubation within 8 hours of the procedure and patient experience reported on a visual analog scale']","[{'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}]","[{'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",20.0,0.486921,"There was no difference in safety outcomes, visual analog scale score or in their willingness to return for repeat procedure.
","[{'ForeName': 'Mujammil', 'Initials': 'M', 'LastName': 'Irfan', 'Affiliation': 'Interventional Respiratory Unit, Galway University Hospital, Newcastle Road, Galway, Ireland.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'The Chest Centre, Aintree University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Breen', 'Affiliation': 'Interventional Respiratory Unit, Galway University Hospital, Newcastle Road, Galway, Ireland.'}]",Journal of bronchology & interventional pulmonology,['10.1097/LBR.0000000000000719']
181,33119068,Efficacy and Safety of a 3-Antigen (Pre-S1/Pre-S2/S) Hepatitis B Vaccine: Results of a Phase 3 Randomized Clinical Trial in the Russian Federation.,"BACKGROUND


This study compares the immunogenicity and safety of a 3-antigen (S/pre-S1/pre-S2) hepatitis B (HepB) vaccine (3AV), to a single antigen vaccine (1AV) in adults to support the registration of 3AV in Russia.
METHODS


We conducted a randomized, double-blind, comparative study of 3-dose regimens of 3AV (10 μg) and 1AV (20 µg) in adults aged 18-45 years. We evaluated immunogenicity based on hepatitis B surface (HBs) antibody titers at days 1, 28, 90, 180, and 210, adverse and serious adverse events (SAEs) to study day 210. The primary outcome was based on the difference in rates of seroconversion at day 210 (lower bound 95% confidence interval [CI]: > - 4%). Secondary outcomes were seroprotection rates (SPR), defined as anti-HBs ≥10 mIU/mL and anti-HBs geometric mean concentration (GMC).
RESULTS


Rate of seroconversion in 3AV (100%) was noninferior to 1AV (97.9%) at study day 210 (difference: 2.1%, 95% CI: -2.0, 6.3%]) but significantly higher at study day 28. SPR at study day 210 was >97% in both arms. Anti-HBs titers were significantly higher at study days 90 (P = .001) and 180 (P = .0001) with 3AV. Sex, age, and body mass index (BMI) had no impact on anti-HBs titers. The rates of local reactions related to vaccination were similar between vaccine arms (3AV vs 1AV) after the first (30% vs 18.8%, P = .15), second (20.0% vs 14.6%, P = .33), and third vaccination (14.9% vs 23.4%, P = .22). No SAEs were reported.
CONCLUSIONS


3AV was noninferior to 1AV. 3AV induced high SPR, and there were no safety concerns. Clinical Trials Registration. NCT04209400.",2021,Anti-HBs titers were significantly higher at Study Days 90 (p = 0.001) and 180 (p = 0.0001) with 3AV.,"['adults aged 18-45 years', 'adults to support the registration of 3AV in Russia']","['3-Antigen (Pre-S1/Pre-S2/S) Hepatitis B Vaccine', '3-antigen (S/preS1/preS2) hepatitis B (HepB) vaccine (3AV', '3AV (10 μg) and 1AV']","['Anti-HBs titers', 'seroprotection rates (SPR), defined as anti-HBs >10 mIU/mL and anti-HBs geometric mean concentration (GMC', 'Efficacy and Safety', 'rates of seroconversion', 'hepatitis B surface (HBs) antibody titers', 'rates of local reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}]","[{'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}]",,0.377046,Anti-HBs titers were significantly higher at Study Days 90 (p = 0.001) and 180 (p = 0.0001) with 3AV.,"[{'ForeName': 'Elena V', 'Initials': 'EV', 'LastName': 'Esaulenko', 'Affiliation': 'Federal State Budgetary Educational Institution of Higher Education; Saint Petersburg State Paediatric Medical University of the Ministry of Health of the Russian Federation, Saint Petersburg, Russia.'}, {'ForeName': 'Aleksey A', 'Initials': 'AA', 'LastName': 'Yakovlev', 'Affiliation': 'St Petersburg State Budgetary Healthcare Institution; S.P. Botkin Clinical Infectious Diseases Hospital, Saint Petersburg, Russia.'}, {'ForeName': 'Genady A', 'Initials': 'GA', 'LastName': 'Volkov', 'Affiliation': 'Pharmsynthez PAO (Publichnoye Aktsionernoye Obshchestvo), Kuzmolovski, Russia.'}, {'ForeName': 'Anastasia A', 'Initials': 'AA', 'LastName': 'Sukhoruk', 'Affiliation': 'Federal State Budgetary Educational Institution of Higher Education; Saint Petersburg State Paediatric Medical University of the Ministry of Health of the Russian Federation, Saint Petersburg, Russia.'}, {'ForeName': 'Kirill G', 'Initials': 'KG', 'LastName': 'Surkov', 'Affiliation': 'Pharmsynthez PAO (Publichnoye Aktsionernoye Obshchestvo), Kuzmolovski, Russia.'}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Kruglyakov', 'Affiliation': 'Pharmsynthez PAO (Publichnoye Aktsionernoye Obshchestvo), Kuzmolovski, Russia.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Diaz-Mitoma', 'Affiliation': 'VBI Vaccines Inc, Cambridge, Massachusetts, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1649']
182,33118206,A brief positive psychological intervention prior to a potentially stressful task facilitates more challenge-like cardiovascular reactivity in high trait anxious individuals.,"When confronted with stress, anxious individuals tend to evaluate the demands of an upcoming encounter as higher than the available resources, thus, indicating threat evaluations. Conversely, evaluating available resources as higher than the demands signals challenge. Both types of evaluations have been related to specific cardiovascular response patterns with higher cardiac output relative to peripheral resistance indicating challenge and higher peripheral resistance relative to cardiac output signaling threat. The aim of this research was to evaluate whether a brief positive psychological exercise (best possible selves intervention) prior to a potentially stress-evoking task shifted the cardiovascular profile in trait anxious individuals from a threat to a challenge type. We randomly assigned 74 participants to either a best possible selves or a control exercise prior to performing a sing a song stress task and assessed their level of trait anxiety. Cardiac output (CO) and total peripheral resistance (TPR) were continuously recorded through baseline, preparation, stress task, and recovery, respectively, as well as self-reported affect. Trait anxiety was related to higher CO in the best possible selves group and lower CO in the control group. While high trait anxious individuals in the control group showed increasing TPR reactivity, they exhibited a nonsignificant change in the best possible selves group. Moreover, in the latter group a stress-related decrease in positive affect in high trait anxious participants was prevented. Findings suggest that concentrating on strengths and positive assets prior to a potentially stressful encounter could trigger a more adaptive coping in trait anxious individuals.",2021,Trait anxiety was related to higher CO in the best possible selves group and lower CO in the control group.,"['trait anxious individuals from a threat to a challenge type', 'high trait anxious individuals']","['positive psychological intervention', 'control exercise prior to performing a sing a song stress task', 'positive psychological exercise (best possible selves intervention']","['TPR reactivity', 'Cardiac output (CO) and total peripheral resistance (TPR', 'Trait anxiety']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0872005', 'cui_str': 'Songs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",74.0,0.0288945,Trait anxiety was related to higher CO in the best possible selves group and lower CO in the control group.,"[{'ForeName': 'Andreas R', 'Initials': 'AR', 'LastName': 'Schwerdtfeger', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rominger', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Aluani', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}]",Psychophysiology,['10.1111/psyp.13709']
183,33119908,The effects of health coaching on frequent attenders' adherence to health regimens and lifestyle factors: a quasi-experimental study.,"AIMS


The aim of this study was to evaluate the effects of nurse-led health coaching on adherence to health regimens and lifestyle factors among frequent attenders in primary health care.
METHODS


One hundred and ten patients were enrolled in the quasi-experimental study. The experimental group (n = 52) received nurse-led health coaching and the control group (n = 58) received conventional care at primary healthcare centres between 2015 and 2016. Data were collected before the intervention and 12 months afterwards using a questionnaire on adherence to health regimens and lifestyle factors. The intervention consisted of individual health coaching provided by a nurse, health-coaching sessions, and a written action plan.
RESULTS


Frequent attenders exhibited good adherence to health regimens. After the intervention, there were no significant differences in adherence to health regimens and/or lifestyle factors between the experimental and control groups. However, nurse-led health coaching improved adherence to health regimens and physical activity in the experimental group.
CONCLUSION


Nurse-led health coaching appears to promote participation and adherence to health regimens among frequent attenders at primary healthcare facilities. Before starting the health-coaching programme, it is recommended to carefully specify the content of health coaching and test the nurses' health-coaching competence.",2021,"After the intervention, there were no significant differences in adherence to health regimens and/or lifestyle factors between the experimental and control groups.","['One hundred and ten patients were enrolled in the quasi-experimental study', 'frequent attenders in primary health care']","['Nurse-led health coaching', 'health coaching', 'nurse-led health coaching and the control group (n\xa0=\xa058) received conventional care', 'nurse-led health coaching', 'individual health coaching provided by a nurse, health-coaching sessions, and a written action plan']",['adherence to health regimens and/or lifestyle factors'],"[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",110.0,0.0142087,"After the intervention, there were no significant differences in adherence to health regimens and/or lifestyle factors between the experimental and control groups.","[{'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Kivelä', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Elo', 'Affiliation': 'Lapland University of Applied Sciences, Kemi, Finland.'}, {'ForeName': 'Helvi', 'Initials': 'H', 'LastName': 'Kyngäs', 'Affiliation': 'Medical Research Center Oulu, University Hospital, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kääriäinen', 'Affiliation': 'Research Unit of Nursing Science and Health Management, Oulu University Hospital, University of Oulu, Oulu, Finland.'}]",Scandinavian journal of caring sciences,['10.1111/scs.12920']
184,33120862,"One-Year Effects of Omega-3 Treatment on Fatty Acids, Oxylipins, and Related Bioactive Lipids and Their Associations with Clinical Lipid and Inflammatory Biomarkers: Findings from a Substudy of the Vitamin D and Omega-3 Trial (VITAL).","Omega-3 (n-3) treatment may lower cardiovascular risk, yet its effects on the circulating lipidome and relation to cardiovascular risk biomarkers are unclear. We hypothesized that n-3 treatment is associated with favorable changes in downstream fatty acids (FAs), oxylipins, bioactive lipids, clinical lipid and inflammatory biomarkers. We examined these VITAL200, a nested substudy of 200 subjects balanced on demographics and treatment and randomly selected from the Vitamin D and Omega-3 Trial (VITAL). VITAL is a randomized double-blind trial of 840 mg/d eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) vs. placebo among 25,871 individuals. Small polar bioactive lipid features, oxylipins and FAs from plasma and red blood cells were measured using three independent assaying techniques at baseline and one year. The Women's Health Study (WHS) was used for replication with dietary n-3 intake. Randomized n-3 treatment led to changes in 143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR) < 0.05 in VITAL200, validated ( p -values < 0.05)) in WHS with increases in 95 including EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids. N-3 related changes in the bioactive lipidome were heterogeneously associated with changes in clinical lipid and inflammatory biomarkers. N-3 treatment significantly modulates the bioactive lipidome, which may contribute to its clinical benefits.",2020,"Randomized n-3 treatment led to changes in 143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR) < 0.05 in VITAL200, validated ( p -values < 0.05)) in WHS with increases in 95 including EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids.","['25,871 individuals', '200 subjects balanced on demographics and treatment and randomly selected from the Vitamin D and Omega-3 Trial (VITAL']","['n-3 treatment', 'Omega-3 Treatment', 'Omega-3 (n-3', 'N-3 treatment', 'eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) vs. placebo']","['downstream fatty acids (FAs), oxylipins, bioactive lipids, clinical lipid and inflammatory biomarkers', 'Fatty Acids, Oxylipins, and Related Bioactive Lipids', '143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR', 'EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids', 'Small polar bioactive lipid features, oxylipins and FAs from plasma and red blood cells']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]",,0.199205,"Randomized n-3 treatment led to changes in 143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR) < 0.05 in VITAL200, validated ( p -values < 0.05)) in WHS with increases in 95 including EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids.","[{'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Demler', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Luttmann-Gibson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Jeramie D', 'Initials': 'JD', 'LastName': 'Watrous', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Lagerborg', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Hesam', 'Initials': 'H', 'LastName': 'Dashti', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Giulianini', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Heath', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harris', 'Affiliation': 'OmegaQuant Analytics, Sioux Falls, SD 57106, USA.'}, {'ForeName': 'Jay G', 'Initials': 'JG', 'LastName': 'Wohlgemuth', 'Affiliation': 'Quest Diagnostics, San Juan Capistrano, CA 92673, USA.'}, {'ForeName': 'Allen M', 'Initials': 'AM', 'LastName': 'Andres', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Tivari', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Long', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Mahan', 'Initials': 'M', 'LastName': 'Najhawan', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Khoi', 'Initials': 'K', 'LastName': 'Dao', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Prentice', 'Affiliation': 'Quest Diagnostics, San Juan Capistrano, CA 92673, USA.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Larsen', 'Affiliation': 'Quest Diagnostics, San Juan Capistrano, CA 92673, USA.'}, {'ForeName': 'Olivia I', 'Initials': 'OI', 'LastName': 'Okereke', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Costenbader', 'Affiliation': ""Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Ctr, Los Angeles, CA 90048, USA.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}]",Metabolites,['10.3390/metabo10110431']
185,33129754,Peer Support Added to Diabetes Education Improves Metabolic Control and Quality of Life in Mayan Adults Living With Type 2 Diabetes: A Randomized Controlled Trial.,"BACKGROUND


Yucatán, located in the southern region of Mexico, is the state with the country's highest prevalence of uncontrolled diabetes. Because of its particular cultural and socioeconomic characteristics, the residents of Yucatán face unique health-care challenges. The objective of our study was to evaluate the effect of peer support added to a diabetes education program on glycemic control and diabetes-related quality of life when compared with a conventional diabetes education program in patients with type 2 diabetes in a Mayan community in Mexico.
METHODS


In March 2015, a total of 58 participants with a previous diagnosis of type 2 diabetes who were recruited from community health centres in Komchén were randomly assigned in equal numbers to 1 of 2 groups: 1) a peer support and diabetes self-management education group (PSEG) or 2) a conventional diabetes self-management education-only group. The primary outcomes of interest were glycated hemoglobin (A1C) values and diabetes-related quality of life. The majority of subjects were bilingual (Mayan and Spanish speakers), female and middle aged, and had a low level of formal education and high baseline A1C (mean, 8.7%).
RESULTS


Whereas both groups showed significant improvements from baseline to study end in absolute levels of A1C, the PSEG group had a more pronounced clinical improvement, but no statistical improvement, in A1C compared with the conventional diabetes self-management education-only group. PSEG participants exhibited statistically significant improvement in diabetes-related quality of life at 8 months.
CONCLUSIONS


Our study demonstrates the benefits of peer-support education above and beyond the impact of diabetes self-management education on diabetes-related quality of life in an underserved Mayan community in Mexico.",2021,"Whereas both groups showed significant improvements from baseline to study end in absolute levels of A1C, the PSEG group had a more pronounced clinical improvement, but no statistical improvement, in A1C compared with the conventional diabetes self-management education-only group.","['patients with type 2 diabetes in a Mayan community in Mexico', '2 Diabetes', 'underserved Mayan community in Mexico', 'subjects were bilingual (Mayan and Spanish speakers), female and middle aged, and had a low level of formal education and high baseline A1C (mean, 8.7', '58 participants with a previous diagnosis of type 2 diabetes who were recruited from community health centres in Komchén', 'Mayan Adults Living With Type']","['peer support added to a diabetes education program', 'conventional diabetes education program', 'peer support and diabetes self-management education group (PSEG) or 2) a conventional diabetes self-management education-only group', 'Peer Support Added to Diabetes Education']","['diabetes-related quality of life', 'glycated hemoglobin (A1C) values and diabetes-related quality of life', 'Metabolic Control and Quality of Life', 'glycemic control and diabetes-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",58.0,0.0458887,"Whereas both groups showed significant improvements from baseline to study end in absolute levels of A1C, the PSEG group had a more pronounced clinical improvement, but no statistical improvement, in A1C compared with the conventional diabetes self-management education-only group.","[{'ForeName': 'Karen G', 'Initials': 'KG', 'LastName': 'Castillo-Hernandez', 'Affiliation': 'Marist University of Mérida, Mérida, Mexico; Faculty of Medicine, Autonomous University of Yucatán, Mérida, Mexico.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Laviada-Molina', 'Affiliation': 'Marist University of Mérida, Mérida, Mexico. Electronic address: hlaviada@marista.edu.mx.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Hernandez-Escalante', 'Affiliation': 'Faculty of Medicine, Autonomous University of Yucatán, Mérida, Mexico.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Molina-Segui', 'Affiliation': 'Marist University of Mérida, Mérida, Mexico.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Mena-Macossay', 'Affiliation': 'Marist University of Mérida, Mérida, Mexico.'}, {'ForeName': 'Augusto E', 'Initials': 'AE', 'LastName': 'Caballero', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, United States.'}]",Canadian journal of diabetes,['10.1016/j.jcjd.2020.08.107']
186,33133658,A four month squatting-based pelvic exercise regime cures day/night enuresis and bowel dysfunction in children aged 7-11 years.,"Introduction


In 2004, Patricia Skilling developed a new squatting-based pelvic floor rehabilitation method based on strengthening the three reflex pelvic muscles and ligaments hypothesized to control the closure and micturition reflexes. We adapted these methods to test our hypothesis that day/night enuresis was due to the inability of these muscles/ligaments to control an inappropriately activated micturition reflex.
Material and methods


The trial commenced as a randomized control trial to be conducted over 4 months, but was converted to a prospective trial at 4 weeks by order of the Ethics Committee. A total of 48 children, 7.6 ±2.5 years, 34 females, 14 males, had strictly supervised exercises twice daily, 10 squats, 10 bridge, fitball exercises involving proprioception exercises with surface perineal electromyogram (EMG) once a week.Eligibility criteria were daytime urine leakage plus night-time bedwetting. Exclusion criterion was refusal to sign consent forms. Assessment was done by intention to treat. The criterion for cure was complete dryness.
Results


At 1 st  review (4 weeks) 12/24 in the treatment group reported total cure of wetting; 41/48 children (86%) were cured of both daytime/nighttime enuresis (p <0.001) at 4 months. There were no adverse events. Secondary outcomes were concomitant cure of constipation, fecal incontinence, urinary retention as predicted by the underlying integral theory of incontinence.
Conclusions


We believe our methods accelerated normal childhood strengthening of muscles/ligaments which control inappropriate activation of the micturition reflex which we hypothesize is the basis for daytime/nighttime enuresis. This is a simple treatment, needs diligent application and validation by others.",2020,There were no adverse events.,"['A total of 48 children, 7.6 ±2.5 years, 34 females, 14 males, had strictly supervised exercises twice daily, 10 squats, 10 bridge', 'children aged 7-11 years']",['fitball exercises involving proprioception exercises with surface perineal electromyogram (EMG'],"['concomitant cure of constipation, fecal incontinence, urinary retention as predicted by the underlying integral theory of incontinence', 'daytime urine leakage plus night-time bedwetting', 'total cure of wetting', 'cured of both daytime/nighttime enuresis']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0152245', 'cui_str': 'Extravasation of urine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0270327', 'cui_str': 'Nocturnal enuresis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162598', 'cui_str': 'Wetability'}, {'cui': 'C0014394', 'cui_str': 'Enuresis'}]",48.0,0.050999,There were no adverse events.,"[{'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Garcia-Fernandez', 'Affiliation': 'Universidad Nacional de Córdoba, Department of Pediatric Surgery, Córdoba, Argentina.'}, {'ForeName': 'Peter Emanuel', 'Initials': 'PE', 'LastName': 'Petros', 'Affiliation': ""University of NSW Professorial, Department of Surgery, St Vincent's Hospital, Sydney, Australia.""}]",Central European journal of urology,['10.5173/ceju.2020.0044']
187,33137174,Do Contact Precautions Reduce the Incidence of Intensive Care Unit-Acquired Pseudomonas aeruginosa Infections? The DPCPYO (Detection and Contact Precautions for Patients With P. aeruginosa) Cluster-Randomized Crossover Trial.,"BACKGROUND


The issue of contact precautions as contributory factors for reducing Pseudomonas aeruginosa (Pa) infections in intensive care units (ICUs) remains questioned. We evaluated the impact of the addition of contact precautions to standard precautions for Pa-positive patients on incidence of ICU-acquired Pa infections.
METHODS


In this multicenter, cluster-randomized crossover trial, 10 French ICUs were randomly assigned (1:1) to sequence 0-1 (6-month control period [CP]/3-month washout period/6-month intervention period [IP]) or sequence 1-0 (6-month IP/3-month washout period/6-month CP). A surveillance screening program for Pa was implemented. Competing-risks regression models were built with death and discharge without the occurrence of ICU-acquired Pa infection (the primary outcome) as competing events. Models were adjusted for within-ICU correlation and patient- and ICU-level covariates. The Simpson diversity index (SDI) and transmission index (TI) of Pa isolates were derived from pulsed-field gel electrophoresis typing.
RESULTS


Within recruited ICUs, the cumulative incidence and incidence rate of ICU-acquired Pa infections were 3.38% (55/1625) versus 3.44% (57/1658) and 3.31 versus 3.52 per 1000 patient-days at risk during the CP and IP, respectively. Multivariable models indicated that the intervention did not significantly change the cumulative incidence (subdistribution hazard ratio, .91; 95% confidence interval [CI], .49-1.67; P = .76) or rate (cause-specific hazard ratio, 1.36; 95% CI, .71-2.63; P = .36) of the primary outcome. SDI and TI did not significantly differ between CP and IP.
CONCLUSIONS


The addition of contact precautions to standard precautions for Pa-positive patients with a surveillance screening program does not significantly reduce ICU-acquired Pa infections in non-outbreak situations. Clinical Trials Registration. ISRCTN92710225.",2021,"Multivariable models indicated that the intervention did not significantly change the cumulative incidence (subdistribution hazard ratio 0.91, 95% confidence interval [CI] 0.49-1.67, p=0.76) and the rate (cause-specific hazard ratio 1.36, 95%CI 0.71-2.63, p=0.36) of the primary outcome.","['10 French ICUs', 'Pa-positive patients on the incidence of ICU-acquired Pa infections']",['sequence 0-1 (6-month control period [CP]/3-month washout period/6-month intervention period [IP]) or sequence 1-0 (6-month IP/3-month washout period/6-month CP'],"['SDI and TI', 'cumulative incidence', 'ICU-acquired Pa infections', 'Simpson diversity index (SDI) and the transmission index (TI) of Pa isolates', 'cumulative incidence and the incidence rate of ICU-acquired Pa infections']","[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}]",,0.112108,"Multivariable models indicated that the intervention did not significantly change the cumulative incidence (subdistribution hazard ratio 0.91, 95% confidence interval [CI] 0.49-1.67, p=0.76) and the rate (cause-specific hazard ratio 1.36, 95%CI 0.71-2.63, p=0.36) of the primary outcome.","[{'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Slekovec', 'Affiliation': 'Infection Control Department, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Robert', 'Affiliation': ""Centre d'Immunologie et des Maladies Infectieuses-Paris, Cimi-Paris, INSERM, Laboratoire de Bactériologie-Hygiène, AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière-Charles Foix, Sorbonne Université, Paris, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Berthelot', 'Affiliation': 'Hygiène Hospitalière et Maladies Infectieuses, Centre Hospitalier Universitaire, Saint-Etienne, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'van der Mee-Marquet', 'Affiliation': 'Service de Bactériologie, Virologie, et Hygiène, Centre Hospitalier Régional Universitaire, Tours, France.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Rogues', 'Affiliation': 'Hygiène Hospitalière, Centre Hospitalier Universitaire, INSERM U657, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Derouin', 'Affiliation': 'Bactériologie-Hygiène, AP-HP, Hôpitaux Universitaires Paris Sud-Clamart, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Cholley', 'Affiliation': 'Infection Control Department, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Bertrand', 'Affiliation': 'Infection Control Department, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Houssein', 'Initials': 'H', 'LastName': 'Gbaguidi-Haore', 'Affiliation': 'Infection Control Department, University Hospital of Besançon, Besançon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1663']
188,33131199,"Favorable effect of sodium-glucose cotransporter 2 inhibitor, dapagliflozin, on non-alcoholic fatty liver disease compared with pioglitazone.","AIMS/INTRODUCTION


Sodium-glucose cotransporter 2 inhibitors, as well as thiazolidines, suppress nonalcoholic fatty liver disease (NAFLD); however, few comparative studies have been reported. Dapagliflozin has shown non-inferiority compared with pioglitazone for glycemic control, and superiority regarding weight reduction in patients with type 2 diabetes. We carried out a secondary analysis for the favorable effects of sodium-glucose cotransporter inhibitors for NAFLD.
MATERIALS AND METHODS


In this multicenter, open-label, prospective, randomized, parallel-group comparison trial, patients taking pioglitazone for ≥12 weeks were randomly switched to dapagliflozin or continued pioglitazone for a further 24 weeks. The fatty liver index (FLI), consisting of body mass index, triglycerides, waist circumference and γ-glutamyl transpeptidase, was used for the evaluation of NAFLD.
RESULTS


A total of 53 participants with NAFLD (27 dapagliflozin; 26 pioglitazone) were included in this analysis. FLI decreased significantly in the dapagliflozin group (48.7 ± 23.4 to 42.1 ± 23.9) compared with the pioglitazone group (49.0 ± 26.1 to 51.1 ± 25.8; P < 0.01). Multiple linear regression analysis showed that the changes in FLI had a significantly positive correlation with changes in glycated hemoglobin (P = 0.03) and insulin level (P < 0.01) in the dapagliflozin group.
CONCLUSION


Dapagliflozin might be more beneficial than pioglitazone in patients with NAFLD. Improvements in FLI would be closely related to glycemic control.",2021,Dapagliflozin has demonstrated non-inferiority compared with pioglitazone for glycemic control and superiority regarding weight reduction in patients with type 2 diabetes.,"['patients with NAFLD', 'patients with type 2 diabetes', 'Fifty-three participants with NAFLD (27 dapagliflozin; 26']","['sodium-glucose co-transporter-2 inhibitor dapagliflozin', 'SGLT2 inhibitors', 'dapagliflozin or continued pioglitazone', 'pioglitazone', 'Dapagliflozin', 'Sodium-glucose co-transporter-2 (SGLT2) inhibitors', 'dapagliflozin']","['nonalcoholic fatty liver disease', 'Fatty liver index (FLI), consisting of body mass index, triglycerides, waist circumference, and γ-glutamyl transpeptidase', 'FLI', 'insulin level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",53.0,0.043359,Dapagliflozin has demonstrated non-inferiority compared with pioglitazone for glycemic control and superiority regarding weight reduction in patients with type 2 diabetes.,"[{'ForeName': 'Kyu Yong', 'Initials': 'KY', 'LastName': 'Cho', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kazuno', 'Initials': 'K', 'LastName': 'Omori', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Takase', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Aika', 'Initials': 'A', 'LastName': 'Miya', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nomoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hiraku', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Taneda', 'Affiliation': 'Diabetes Center, Manda Memorial Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Kurihara Clinic, Sapporo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Aoki Clinic, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13457']
189,33139686,Efficacy of an exercise program combined with lifestyle education in patients with knee osteoarthritis.,"Therapeutic exercise and lifestyle changes (LS) are usually recommended for the treatment of knee osteoarthritis (OA).
OBJECTIVES


to compare the impact of an exercise program vs. exercise program plus LS education in individuals with knee OA.
MATERIALS AND METHODS


Single-blind randomized clinical trial with individuals of both sexes with clinical and radiological diagnosis of knee OA. Participants received the treatment 2 times/week for 8 weeks. Therapeutic exercise involved warm-up, flexibility, muscle strengthening, balance and proprioception. The exercise plus lifestyle education group (ELG) also participated in 8 sessions of lectures and discussion on disease self-management and healthy LS. Participants were assessed for pain intensity (visual analog scale), lifestyle, symptoms and physical disability (WOMAC) and pressure pain tolerance threshold (PPT).
RESULTS


Sample consisted of 39 participants, divided into exercise group (EG, n=17) and ELG (n=22). Groups were homogeneous regarding regarding age, weight, height, initial pain perception (VAS) and gender predominance age and body mass index. After the interventions, reduction in pain perception and increase in PPT was observed in both groups. Despite the improvement in LS of both groups, only ELG exhibited a significant reduction in pain assessed by WOMAC. Therapeutic exercise programs may produce pain relief, but no improvements were observed in joint stiffness and funcionality.",2020,"Despite the improvement in LS of both groups, only ELG exhibited a significant reduction in pain assessed by WOMAC.","['individuals with knee OA', 'individuals of both sexes with clinical and radiological diagnosis of knee OA', 'patients with knee osteoarthritis']","['Therapeutic exercise and lifestyle changes (LS', 'ELG', 'exercise program vs. exercise program plus LS education', 'exercise program combined with lifestyle education', 'Therapeutic exercise programs', 'exercise plus lifestyle education group (ELG) also participated in 8 sessions of lectures and discussion on disease self-management and healthy LS']","['pain intensity (visual analog scale), lifestyle, symptoms and physical disability (WOMAC) and pressure pain tolerance threshold (PPT', 'pain perception and increase in PPT', 'pain assessed by WOMAC', 'pain relief', 'Therapeutic exercise involved warm-up, flexibility, muscle strengthening, balance and proprioception']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0677038', 'cui_str': 'Increase in pressure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",39.0,0.0237079,"Despite the improvement in LS of both groups, only ELG exhibited a significant reduction in pain assessed by WOMAC.","[{'ForeName': 'Fábio Marcon', 'Initials': 'FM', 'LastName': 'Alfieri', 'Affiliation': 'Adventist University of Sao Paulo e University of Sao Paulo.'}, {'ForeName': 'Alessandra Rodrigues Souto', 'Initials': 'ARS', 'LastName': 'Lima', 'Affiliation': 'Adventist University of Sao Paulo.'}, {'ForeName': 'Marcia Maria Hernandes de Abreu de Oliveira', 'Initials': 'MMHAO', 'LastName': 'Salgueiro', 'Affiliation': 'Adventist University of Sao Paulo.'}, {'ForeName': 'Elisabete Agrela de', 'Initials': 'EA', 'LastName': 'Andrade', 'Affiliation': 'Adventist University of Sao Paulo.'}, {'ForeName': 'Linamara Rizzo', 'Initials': 'LR', 'LastName': 'Battistella', 'Affiliation': 'University of Sao Paulo.'}, {'ForeName': 'Natália Cristina de Oliveira Vargas E', 'Initials': 'NCOVE', 'LastName': 'Silva', 'Affiliation': 'Adventist University of Sao Paulo.'}]",Acta reumatologica portuguesa,[]
190,33140994,Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder.,"OBJECTIVES


To evaluate the safety and efficacy of a digital therapeutic in treatment-seeking individuals with opioid use disorder (OUD) in an analysis of randomized clinical trial (RCT) data (ClinicalTrials.gov identifier: NCT00929253).
METHODS


Secondary analysis of an RCT including 170 adults meeting DSM-IV criteria for OUD. Participants were randomized to 12-weeks of treatment-as-usual (TAU) or TAU plus a digital therapeutic providing 67 digital, interactive educational modules based on the Community Reinforcement Approach. TAU consisted of buprenorphine maintenance therapy, 30 min biweekly clinician interaction, and abstinence-based contingency management. Primary endpoints were treatment retention and abstinence (negative urine drug screen) during weeks 9-12 of treatment. Safety was assessed by evaluating adverse events.
RESULTS


Participants randomized to TAU plus a digital therapeutic had significantly greater odds of opioid abstinence during weeks 9-12 compared to TAU: 77.3 versus 62.1%, respectively ( p =.02), OR 2.08, 95% CI 1.10-3.95. The risk of patients leaving treatment was significantly lower in the digital therapeutic group (HR 0.49, 95% CI 0.26-0.92). No significant difference was observed in the rate of adverse events between groups ( p= .42).
CONCLUSIONS


A prescription digital therapeutic (PDT) in combination with buprenorphine therapy improves clinically significant patient outcomes including abstinence from illicit opioids and retention in treatment compared with treatment as usual.",2021,"The risk of patients leaving treatment was significantly lower in the digital therapeutic group (HR 0.49, 95% CI 0.26-0.92).","['170 adults meeting DSM-IV criteria for OUD', 'treatment-seeking individuals with opioid use disorder (OUD']","['TAU plus a digital therapeutic', 'buprenorphine therapy', 'prescription digital therapeutic', 'buprenorphine', 'buprenorphine maintenance therapy', 'treatment-as-usual (TAU) or TAU plus a digital therapeutic providing 67 digital, interactive educational modules based on the Community Reinforcement Approach', 'digital therapeutic']","['Safety', 'Safety and efficacy', 'safety and efficacy', 'opioid abstinence', 'abstinence from illicit opioids and retention', 'treatment retention and abstinence (negative urine drug screen', 'risk of patients leaving treatment', 'rate of adverse events']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",170.0,0.183941,"The risk of patients leaving treatment was significantly lower in the digital therapeutic group (HR 0.49, 95% CI 0.26-0.92).","[{'ForeName': 'Yuri A', 'Initials': 'YA', 'LastName': 'Maricich', 'Affiliation': 'Pear Therapeutics, Inc., Boston, MA, USA.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Fralin Biomedical Research Institute at VTC, Roanoke, VA, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Marsch', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Gatchalian', 'Affiliation': 'Fralin Biomedical Research Institute at VTC, Roanoke, VA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Botbyl', 'Affiliation': 'Provonix, Sewell, NJ, USA.'}, {'ForeName': 'Hilary F', 'Initials': 'HF', 'LastName': 'Luderer', 'Affiliation': 'Pear Therapeutics, Inc., Boston, MA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1846022']
191,33140566,Sitagliptin for the prevention and treatment of perioperative hyperglycaemia in patients with type 2 diabetes undergoing cardiac surgery: A randomized controlled trial.,"AIM


To assess whether treatment with sitagliptin, starting before surgery and continued during the hospital stay, can prevent and reduce the severity of perioperative hyperglycaemia in patients with type 2 diabetes undergoing coronary artery bypass graft (CABG) surgery.
MATERIALS AND METHODS


We conducted a double-blinded, placebo-controlled trial in adults with type 2 diabetes randomly assigned to receive sitagliptin or matching placebo starting 1 day prior to surgery and continued during the hospital stay. The primary outcome was difference in the proportion of patients with postoperative hyperglycaemia (blood glucose [BG] > 10 mmol/L [>180 mg/dL]) in the intensive care unit (ICU). Secondary endpoints included differences in mean daily BG in the ICU and after transition to regular wards, hypoglycaemia, hospital complications, length of stay and need of insulin therapy.
RESULTS


We included 182 participants randomized to receive sitagliptin or placebo (91 per group, age 64 ± 9 years, HbA1c 7.6% ± 1.5% and diabetes duration 10 ± 9 years). There were no differences in the number of patients with postoperative BG greater than 10 mmol/L, mean daily BG in the ICU or after transition to regular wards, hypoglycaemia, hospital complications or length of stay. There were no differences in insulin requirements in the ICU; however, sitagliptin therapy was associated with lower mean daily insulin requirements (21.1 ± 18.4 vs. 32.5 ± 26.3 units, P = .007) after transition to a regular ward compared with placebo.
CONCLUSION


The administration of sitagliptin prior to surgery and during the hospital stay did not prevent perioperative hyperglycaemia or complications after CABG. Sitagliptin therapy was associated with lower mean daily insulin requirements after transition to regular wards.",2021,"There were no differences in number of patients with postoperative BG >10 mmol/L, mean daily BG in the ICU or after transition to regular floors, hypoglycaemia, hospital complications or length of stay.","['Undergoing Cardiac Surgery', 'Patients with Type 2 Diabetes', 'adults with type 2 diabetes randomly assigned to receive', '182 participants randomised to receive', 'patients with type 2 diabetes undergoing coronary artery bypass graft (CABG) surgery']","['Sitagliptin therapy', 'sitagliptin or matching placebo', '10mmol/L', 'Sitagliptin', 'sitagliptin or placebo', 'placebo']","['mean daily insulin requirements', 'insulin requirements', 'hypoglycaemia, hospital complications or length of stay', 'proportion of patients with postoperative hyperglycaemia (blood glucose [BG] ', 'Perioperative Hyperglycaemia', 'perioperative hyperglycaemia or complications', 'mean daily BG in the ICU and after transition to regular wards, hypoglycaemia, hospital complications, length of stay, and need of insulin therapy']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",182.0,0.356821,"There were no differences in number of patients with postoperative BG >10 mmol/L, mean daily BG in the ICU or after transition to regular floors, hypoglycaemia, hospital complications or length of stay.","[{'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Tsegka', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Sol', 'Initials': 'S', 'LastName': 'Jacobs', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Halkos', 'Affiliation': 'Joseph B. Whitehead Department of Surgery, Emory University, Atlanta, Georgia.'}, {'ForeName': 'W Brent', 'Initials': 'WB', 'LastName': 'Keeling', 'Affiliation': 'Joseph B. Whitehead Department of Surgery, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Albury', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Urrutia', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Rodolfo J', 'Initials': 'RJ', 'LastName': 'Galindo', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Migdal', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Macheers', 'Affiliation': 'Joseph B. Whitehead Department of Surgery, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Guyton', 'Affiliation': 'Joseph B. Whitehead Department of Surgery, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14241']
192,33179263,Treatment Outcomes in Patients Treated With Galcanezumab vs Placebo: Post Hoc Analyses From a Phase 3 Randomized Study in Patients With Episodic Cluster Headache.,"BACKGROUND


Cluster headache (CH) is a highly disabling primary headache disorder. To date, characterization of outcomes in the preventive treatment of episodic CH, including precise definitions of clinically meaningful attack frequency reduction and impact on acute treatment management, is lacking.
METHODS


This was a Phase 3, randomized, double-blind, placebo-controlled study in patients (men or women aged 18-65 years) diagnosed with episodic CH as defined by the International Classification of Headache Disorders-3 beta criteria. In this post hoc analysis, we evaluated the median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attack frequency, and impact on acute medication use. An anchor-based assessment of clinically relevant attack frequency reduction using the Patient Global Impression of Improvement (PGI-I) scores at Week 4 was also assessed.
RESULTS


The median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attacks was consistently shorter (9-10 days sooner) with galcanezumab vs placebo (median [95% confidence interval, 95% CI]: ≥50%, 5 days [4.0 to 7.0] vs 14 days [6.0 to 19.0]; ≥75%, 11 days [7.0 to 16.0] vs 21 days [13.0 to 26.0]; 100%, 22 days [16.0 to 37.0] vs 32 days [23.0 to 34.0]). Mean reduction from baseline in the overall frequency of weekly pooled acute medication use across Weeks 1-3 was significantly greater with galcanezumab vs placebo (11.0 vs 5.5; odds ratio, OR [95% CI]: 5.52 [1.02, 10.01]; P value = .017). Patients reporting ""much better"" on the PGI-I experienced a median weekly CH attack reduction of approximately 43% from baseline across Weeks 1-3. The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3]).
CONCLUSIONS


Faster median time-to-first occurrence of response rates, lower frequency of pooled acute medications use, and a greater proportion of patients achieving a response anchored by patient-reported improvement were observed for galcanezumab vs placebo.",2020,"The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3]).
","['Patients With Episodic Cluster Headache', 'patients (men or women aged 18-65\xa0years) diagnosed with episodic CH as defined by the International Classification of Headache Disorders-3 beta criteria']","['placebo', 'galcanezumab vs placebo', 'Galcanezumab vs Placebo']","['median time-to-first occurrence', 'CH attacks', 'overall odds of achieving an attack reduction', 'median weekly CH attack reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393739', 'cui_str': 'Episodic cluster headache'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0393735', 'cui_str': 'Headache disorder'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",,0.635537,"The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3]).
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kudrow', 'Affiliation': 'California Medical Clinic for Headache, Santa Monica, CA, USA.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Andrews', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mallikarjuna', 'Initials': 'M', 'LastName': 'Rettiganti', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Oakes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bardos', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Gaul', 'Affiliation': 'Migraine and Headache Clinic, Koenigstein, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riesenberg', 'Affiliation': 'Atlanta Center for Medical Research, Atlanta, GA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wenzel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Dulanji', 'Initials': 'D', 'LastName': 'Kuruppu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.14011']
193,33146345,Cannabidiol for the treatment of crack-cocaine craving: an exploratory double-blind study.,"OBJECTIVE


To assess the efficacy of cannabidiol (CBD) in the management of crack-cocaine craving and the treatment of frequent withdrawal symptoms.
METHODS


Thirty-one men with a diagnosis of crack-cocaine dependence were enrolled in a randomized, double-blind, placebo-controlled trial. We applied neuropsychological tests and assessed craving intensity, anxiety and depression symptoms, and substance use patterns at baseline and at the end of the trial. The participants were treated with CBD 300 mg/day or placebo for 10 days. During this period, we used a technique to induce craving and assessed the intensity of symptoms before and after the induction procedure.
RESULTS


Craving levels reduced significantly over the 10 days of the trial, although no differences were found between the CBD and placebo groups. Craving induction was successful in both groups, with no significant differences between them. Indicators of anxiety, depression, and sleep alterations before and after treatment also did not differ across groups.
CONCLUSION


Under the conditions of this trial, CBD was unable to interfere with symptoms of crack-cocaine withdrawal. Further studies with larger outpatient samples involving different doses and treatment periods would be desirable and timely to elucidate the potential of CBD to induce reductions in crack-cocaine self-administration.",2020,"RESULTS


Craving levels reduced significantly over the 10 days of the trial, although no differences were found between the CBD and placebo groups.","['Thirty-one men with a diagnosis of crack-cocaine dependence', 'crack-cocaine craving']","['CBD 300 mg/day or placebo', 'placebo', 'cannabidiol (CBD']","['Indicators of anxiety, depression, and sleep alterations', 'craving intensity, anxiety and depression symptoms, and substance use patterns', 'Craving induction', 'Craving levels']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085163', 'cui_str': 'Cocaine freebase'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",31.0,0.184789,"RESULTS


Craving levels reduced significantly over the 10 days of the trial, although no differences were found between the CBD and placebo groups.","[{'ForeName': 'Carolina de', 'Initials': 'C', 'LastName': 'Meneses-Gaya', 'Affiliation': 'Laboratório Interdisciplinar de Neurociências Clínicas (LiNC), Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Crippa', 'Affiliation': 'Divisão de Psiquiatria, Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (FMRP-USP), Ribeirão Preto, São Paulo, SP, Brazil.'}, {'ForeName': 'Jaime E', 'Initials': 'JE', 'LastName': 'Hallak', 'Affiliation': 'Divisão de Psiquiatria, Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (FMRP-USP), Ribeirão Preto, São Paulo, SP, Brazil.'}, {'ForeName': 'André Q', 'Initials': 'AQ', 'LastName': 'Miguel', 'Affiliation': 'Departamento de Psiquiatria, Instituto Nacional de Políticas Públicas do Álcool e Drogas (INPAD), UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Laranjeira', 'Affiliation': 'Departamento de Psiquiatria, Instituto Nacional de Políticas Públicas do Álcool e Drogas (INPAD), UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Rodrigo A', 'Initials': 'RA', 'LastName': 'Bressan', 'Affiliation': 'Laboratório Interdisciplinar de Neurociências Clínicas (LiNC), Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Antonio W', 'Initials': 'AW', 'LastName': 'Zuardi', 'Affiliation': 'Divisão de Psiquiatria, Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (FMRP-USP), Ribeirão Preto, São Paulo, SP, Brazil.'}, {'ForeName': 'Acioly L', 'Initials': 'AL', 'LastName': 'Lacerda', 'Affiliation': 'Laboratório Interdisciplinar de Neurociências Clínicas (LiNC), Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2020-1416']
194,33164941,Effects of Pridopidine on Functional Capacity in Early-Stage Participants from the PRIDE-HD Study.,"BACKGROUND


No pharmacological treatment has been demonstrated to provide a functional benefit for persons with Huntington's disease (HD). Pridopidine is a sigma-1-receptor agonist shown to have beneficial effects in preclinical models of HD.
OBJECTIVE


To further explore the effect of pridopidine on Total Functional Capacity (TFC) in the recent double-blind, placebo-controlled PRIDE-HD study.
METHODS


We performed post-hoc analyses to evaluate the effect of pridopidine on TFC at 26 and 52 weeks. Participants were stratified according to baseline TFC score and analyzed using repeated measures (MMRM) and multiple imputation assuming missing not-at-random (MNAR) and worst-case scenarios.
RESULTS


The pridopidine 45 mg bid dosage demonstrated a beneficial effect on TFC for the entire population at week 52 of 0.87 (nominal p = 0.0032). The effect was more pronounced for early HD participants (HD1/HD2, TFC = 7-13), with a change from placebo of 1.16 (nominal p = 0.0003). This effect remained nominally significant using multiple imputation with missing not at random assumption as a sensitivity analysis. Responder analyses showed pridopidine 45 mg bid reduced the probability of TFC decline in early HD patients at Week 52 (nominal p = 0.02).
CONCLUSION


Pridopidine 45 mg bid results in a nominally significant reduction in TFC decline at 52 weeks compared to placebo, particularly in patients with early-stage HD.",2020,"The effect was more pronounced for early HD participants (HD1/HD2, TFC = 7-13), with a change from placebo of 1.16 (nominal p = 0.0003).","[""persons with Huntington's disease (HD"", 'Early-Stage Participants from the PRIDE-HD Study']","['Pridopidine', 'pridopidine', 'placebo']","['Total Functional Capacity (TFC', 'probability of TFC decline', 'Functional Capacity', 'TFC decline']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1741584', 'cui_str': 'pridopidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.125887,"The effect was more pronounced for early HD participants (HD1/HD2, TFC = 7-13), with a change from placebo of 1.16 (nominal p = 0.0003).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McGarry', 'Affiliation': 'Cooper University Healthcare at Rowan University, Camden, NJ, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Clintrex Research Corporation, Sarasota, FL, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kieburtz', 'Affiliation': 'Clintrex Research Corporation, Sarasota, FL, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Geva', 'Affiliation': 'Prilenia Therapeutics, Herzliya, Israel.'}, {'ForeName': 'C Warren', 'Initials': 'CW', 'LastName': 'Olanow', 'Affiliation': 'Mount Sinai School of Medicine, New York City, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hayden', 'Affiliation': 'Prilenia Therapeutics, Herzliya, Israel.'}]",Journal of Huntington's disease,['10.3233/JHD-200440']
195,33164945,Continuous Subcutaneous Levodopa Delivery for Parkinson's Disease: A Randomized Study.,"BACKGROUND


ND0612 is a continuous, subcutaneous levodopa/carbidopa delivery system in development for patients with Parkinson's disease (PD) experiencing motor fluctuationsObjective:Evaluate the efficacy and safety of two ND0612 dosing regimens in patients with PD.
METHODS


This was a 28-day open-label study (NCT02577523) in PD patients with ≥2.5 hours/day of OFF time despite optimized treatment. Patients were randomized to treatment with either a 24-hour infusion (levodopa/carbidopa dose of 720/90 mg) or a 14-hour 'waking-day' infusion (levodopa/carbidopa dose of 538/68 mg plus a morning oral dose of 150/15 mg). Supplemental oral doses of levodopa were permitted for patients in both groups if required. In-clinic assessments of OFF time (primary endpoint) and ON time with or without dyskinesia were determined by a blinded rater over 8 hours (normalized to 16 hours).
RESULTS


A total of 38 patients were randomized and 33 (87%) completed the study. Compared to baseline, OFF time for the overall population was reduced by a least squares (LS) mean[95% CI] of 2.0[- 3.3, - 0.7] hours (p = 0.003). ON time with no/mild dyskinesia (no troublesome dyskinesia) was increased from baseline by a LS mean of 3.3[2.0, 4.6] hours (p < 0.0001), and ON time with moderate/severe dyskinesia was reduced by a LS mean of 1.2[- 1.8, - 0.5] hours (p≤0.001). Reduction in OFF time was larger in the 24-hour group (- 2.8[- 4.6, - 0.9] hours; p = 0.004) than in the 14-hour group (- 1.3[- 3.1, 0.5] hours; p = 0.16). Complete resolution of OFF time was observed in 42% (n = 8) of patients in the 24-hour group. Infusion site reactions were the most common adverse event.
CONCLUSION


This study demonstrates the feasibility and safety of continuous subcutaneous delivery of levodopa as a treatment for PD and provides preliminary evidence of efficacy.",2021,Complete resolution of OFF time was observed in 42% (n = 8) of patients in the 24-hour group.,"[""Parkinson's Disease"", 'patients with PD', 'PD patients with ≥2.5 hours/day of OFF time despite optimized treatment', ""patients with Parkinson's disease (PD) experiencing motor fluctuationsObjective"", '38 patients were randomized and 33 (87% ) completed the study']","['levodopa', 'levodopa/carbidopa delivery system', ""24-hour infusion (levodopa/carbidopa dose of 720/90\u200amg) or a 14-hour 'waking-day' infusion (levodopa/carbidopa""]","['Complete resolution of OFF time', 'OFF time (primary endpoint) and ON time with or without dyskinesia', 'ON time with no/mild dyskinesia', 'efficacy and safety', 'Reduction in OFF time', 'OFF time', 'ON time with moderate/severe dyskinesia']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",38.0,0.079001,Complete resolution of OFF time was observed in 42% (n = 8) of patients in the 24-hour group.,"[{'ForeName': 'C Warren', 'Initials': 'CW', 'LastName': 'Olanow', 'Affiliation': 'Clintrex Research Corp, Sarasota, FL, USA.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': ""James J and Joan A Gardner Center for Parkinson's disease and Movement Disorders, University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Stocchi', 'Affiliation': 'University and Institute for Research and Medical Care IRCCS San Raffaele, Roma, Italy.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Ellenbogen', 'Affiliation': 'Michigan Institute for Neurological Disorders, Farmington Hills, MI, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Clintrex Research Corp, Sarasota, FL, USA.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Adar', 'Affiliation': 'NeuroDerm Ltd., Rehovot, Israel.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Case', 'Affiliation': 'NeuroDerm Ltd., Rehovot, Israel.'}, {'ForeName': 'Shir Fuchs', 'Initials': 'SF', 'LastName': 'Orenbach', 'Affiliation': 'NeuroDerm Ltd., Rehovot, Israel.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Yardeni', 'Affiliation': 'NeuroDerm Ltd., Rehovot, Israel.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Oren', 'Affiliation': 'NeuroDerm Ltd., Rehovot, Israel.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Parkinson's disease,['10.3233/JPD-202285']
196,33175158,Dialectical Pain Management: Feasibility of a Hybrid Third-Wave Cognitive Behavioral Therapy Approach for Adults Receiving Opioids for Chronic Pain.,"OBJECTIVES


This study evaluated the feasibility, acceptability, and potential effectiveness of a hybrid skills-based group intervention, dialectical pain management (DPM), for adults with chronic pain who are receiving long-term opioid therapy. DPM adapts dialectical behavior therapy, a rigorous psychotherapeutic approach to emotion dysregulation, to treat disorders of physiological dysregulation.
METHODS


Individuals with chronic pain (N = 17) participated in one of two 8-week DPM intervention cohorts. At pre-test and post-test, participants completed quantitative self-report assessments measuring pain intensity and interference, depressive symptoms, pain acceptance, beliefs about pain medications, and global rating of change. Within 2 weeks after the intervention, participants completed qualitative interviews to assess participant satisfaction and obtain feedback about specific intervention components.
RESULTS


Of the 17 enrolled, 15 participants completed the group with 12 (70%) attending six or more sessions. Participants reported high satisfaction with the intervention. Preliminary findings suggested a significant increase in pain acceptance and a significant reduction in depressive symptoms. Participants also reported an improved relationship with their pain conditions and increased flexibility in responding to pain and applying coping skills. Several participants showed a reduction in opioid dosage over the course of the intervention.
DISCUSSION


Findings support that DPM is a feasible and well-received intervention for individuals with chronic pain. Additional research with a control group is needed to further determine the intervention's efficacy and impact.",2021,"This study evaluated the feasibility, acceptability, and potential effectiveness of a hybrid skills-based group intervention, dialectical pain management (DPM), for adults with chronic pain who are receiving long-term opioid therapy.","['individuals with chronic pain', 'Individuals with chronic pain (N\u2009=\u200917) participated in one of two 8-week DPM intervention cohorts', 'enrolled, 15 participants completed the group with 12 (70%) attending six or more sessions', 'Adults Receiving Opioids for Chronic Pain', 'adults with chronic pain who are receiving long-term opioid therapy']","['hybrid skills-based group intervention, dialectical pain management (DPM', 'DPM adapts dialectical behavior therapy', 'Hybrid Third-Wave Cognitive Behavioral Therapy Approach']","['flexibility in responding to pain and applying coping skills', 'depressive symptoms', 'pain acceptance', 'pain intensity and interference, depressive symptoms, pain acceptance, beliefs about pain medications, and global rating of change']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C4083063', 'cui_str': 'Responds to pain'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.10432,"This study evaluated the feasibility, acceptability, and potential effectiveness of a hybrid skills-based group intervention, dialectical pain management (DPM), for adults with chronic pain who are receiving long-term opioid therapy.","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Barrett', 'Affiliation': 'University of North Carolina School of Social Work, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Carrie E', 'Initials': 'CE', 'LastName': 'Brintz', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Zaski', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Edlund', 'Affiliation': 'RTI International, North Carolina, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa361']
197,33181558,Postoperative Neurocognitive Disorders After Closed-Loop Versus Manual Target Controlled-Infusion of Propofol and Remifentanil in Patients Undergoing Elective Major Noncardiac Surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial.,"BACKGROUND


The aim of the study was to investigate whether closed-loop compared to manual bispectral index (BIS)-guided target-controlled infusion of propofol and remifentanil could decrease the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery.
METHODS


Patients aged >50 admitted for elective major noncardiac surgery were included in a single-blind randomized (ratio 2:1) trial. The anesthetic protocol was allocated by randomization into either closed-loop or manual BIS-guided propofol and remifentanil titration. The BIS target range was 40-60. All patients had cognitive assessment the day before surgery and within 72 hours after surgery using a battery of neuropsychological tests. The primary outcome was the rate of postoperative neurocognitive disorders. Postoperative neurocognitive disorders were defined as a decrease >20% from baseline on at least 3 scores. Intergroup comparison of the primary outcome was performed using the χ2 test.
RESULTS


A total of 143 and 61 patients were included in the closed-loop and manual groups, respectively (age: 66 [8] vs 66 [9] years). The primary outcome was observed in 18 (13%) and 10 (16%) patients of the closed-loop and manual groups, respectively (relative risk [95% confidence interval {CI}], 0.77 [0.38-1.57], P = .47). Intraoperative propofol consumption was lower (4.7 [1.4] vs 5.7 [1.4] mg·kg-1·h-1, mean difference [MD] [95% CI], -0.73 [-0.98 to -0.48], P < .0001) and the proportion of time within the BIS target range higher (84 [77-89] vs 74 [54-81]%, MD [95% CI], 0.94 [0.67-1.21], P < .0001) in the closed-loop group.
CONCLUSIONS


Closed-loop compared to manual BIS-guided total intravenous anesthesia provided a significant reduction in episodes of an excessive depth of anesthesia while decreasing intraoperative propofol requirement but no evidence for a reduction of the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery was observed.",2021,"Intraoperative propofol consumption was lower (4.7 [1.4] vs 5.7 [1.4] mg·kg·h, mean difference [MD] [95% CI], -0.73 [-0.98 to -0.48], P < .0001) and the proportion of time within the BIS target range higher (84 [77-89] vs 74 [54-81]%, MD [95% CI], 0.94 [0.67-1.21], P < .0001) in the closed-loop group.
","['A total of 143 and 61 patients were included in the closed-loop and manual groups, respectively (age: 66 [8] vs 66 [9] years', 'Patients Undergoing Elective Major Noncardiac Surgery', 'Patients aged >50 admitted for elective major noncardiac surgery', 'postoperative neurocognitive disorders after elective major noncardiac surgery']","['closed-loop compared to manual bispectral index (BIS)-guided target-controlled infusion of propofol and remifentanil', 'Propofol and Remifentanil', 'closed-loop or manual BIS-guided propofol and remifentanil titration']","['rate of postoperative neurocognitive disorders', 'Postoperative Neurocognitive Disorders', 'proportion of time within the BIS target range higher', 'Intraoperative propofol consumption', 'Postoperative neurocognitive disorders']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.285158,"Intraoperative propofol consumption was lower (4.7 [1.4] vs 5.7 [1.4] mg·kg·h, mean difference [MD] [95% CI], -0.73 [-0.98 to -0.48], P < .0001) and the proportion of time within the BIS target range higher (84 [77-89] vs 74 [54-81]%, MD [95% CI], 0.94 [0.67-1.21], P < .0001) in the closed-loop group.
","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Mahr', 'Affiliation': 'From the Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Bouhake', 'Affiliation': 'From the Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Chopard', 'Affiliation': 'Department of Neurology, University Hospital of Besancon, and EA 481 Neuroscience, IFR 133, University of Bourgogne Franche-Comte, Besancon, France.'}, {'ForeName': 'Ngai', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Boichut', 'Affiliation': 'From the Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Chazot', 'Affiliation': 'Department of Anesthesiology, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Claveau', 'Affiliation': 'From the Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Vettoretti', 'Affiliation': 'From the Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Tio', 'Affiliation': 'Department of Clinical Psychiatry, and Clinical Investigation Center, INSERM CIT 808, University Hospital of Besancon, Besancon, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Pili-Floury', 'Affiliation': 'From the Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Samain', 'Affiliation': 'From the Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Besch', 'Affiliation': 'From the Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005278']
198,33185028,Brigatinib Dose Rationale in Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: Exposure-Response Analyses of Pivotal ALTA Study.,"Brigatinib is a kinase inhibitor indicated for patients with advanced anaplastic lymphoma kinase-positive non-small cell lung cancer who progressed on or are intolerant to crizotinib. Approval was based on results from a randomized, dose-ranging phase II study (ALK in Lung Cancer Trial of AP26113 (ALTA)). Despite an apparent dose-response relationship for efficacy in ALTA, an exposure-response relationship was not discernable using static models driven by time-averaged exposure. However, exposure-response modeling using daily time-varying area under the concentration curve as the predictor in time-to-event models predicted that increasing the dose of brigatinib (range, 30 mg once daily (q.d.) to 240 mg q.d.) would result in clinically meaningful improvements in progression-free survival (PFS), intracranial PFS, and overall survival. Grade ≥ 2 rash and amylase elevation were predicted to significantly increase with brigatinib exposure. These results provided support for a favorable benefit-risk profile with the approved dosing regimen (180 mg q.d. with 7-day lead-in at 90 mg) versus 90 mg q.d.",2020,Grade ≥2 rash and amylase elevation were predicted to significantly increase with brigatinib exposure.,['patients with advanced anaplastic lymphoma kinase-positive non-small cell lung cancer who progressed on or are intolerant to crizotinib'],[],"['progression-free survival (PFS), intracranial PFS, and overall survival', 'Grade ≥2 rash and amylase elevation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}]",[],"[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",,0.0261283,Grade ≥2 rash and amylase elevation were predicted to significantly increase with brigatinib exposure.,"[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Certara, Princeton, New Jersey, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Offman', 'Affiliation': 'Certara, Princeton, New Jersey, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rich', 'Affiliation': 'Certara, Princeton, New Jersey, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kerstein', 'Affiliation': 'Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hanley', 'Affiliation': 'Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Diderichsen', 'Affiliation': 'Certara, Princeton, New Jersey, USA.'}, {'ForeName': 'Pingkuan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.'}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12569']
199,33185650,Clinical Outcomes and Response to Vericiguat According to Index Heart Failure Event: Insights From the VICTORIA Trial.,"Importance


The period following heart failure hospitalization (HFH) is a vulnerable time with high rates of death or recurrent HFH.
Objective


To evaluate clinical characteristics, outcomes, and treatment response to vericiguat according to prespecified index event subgroups and time from index HFH in the Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) trial.
Design, Setting, and Participants


Analysis of an international, randomized, placebo-controlled trial. All VICTORIA patients had recent (<6 months) worsening HF (ejection fraction <45%). Index event subgroups were less than 3 months after HFH (n = 3378), 3 to 6 months after HFH (n = 871), and those requiring outpatient intravenous diuretic therapy only for worsening HF (without HFH) in the previous 3 months (n = 801). Data were analyzed between May 2, 2020, and May 9, 2020.
Intervention


Vericiguat titrated to 10 mg daily vs placebo.
Main Outcomes and Measures


The primary outcome was time to a composite of HFH or cardiovascular death; secondary outcomes were time to HFH, cardiovascular death, a composite of all-cause mortality or HFH, all-cause death, and total HFH.
Results


Among 5050 patients in the VICTORIA trial, mean age was 67 years, 24% were women, 64% were White, 22% were Asian, and 5% were Black. Baseline characteristics were balanced between treatment arms within each subgroup. Over a median follow-up of 10.8 months, the primary event rates were 40.9, 29.6, and 23.4 events per 100 patient-years in the HFH at less than 3 months, HFH 3 to 6 months, and outpatient worsening subgroups, respectively. Compared with the outpatient worsening subgroup, the multivariable-adjusted relative risk of the primary outcome was higher in HFH less than 3 months (adjusted hazard ratio, 1.48; 95% CI, 1.27-1.73), with a time-dependent gradient of risk demonstrating that patients closest to their index HFH had the highest risk. Vericiguat was associated with reduced risk of the primary outcome overall and in all subgroups, without evidence of treatment heterogeneity. Similar results were evident for all-cause death and HFH. Addtionally, a continuous association between time from HFH and vericiguat treatment showed a trend toward greater benefit with longer duration since HFH. Safety events (symptomatic hypotension and syncope) were infrequent in all subgroups, with no difference between treatment arms.
Conclusions and Relevance


Among patients with worsening chronic HF, those in closest proximity to their index HFH had the highest risk of cardiovascular death or HFH, irrespective of age or clinical risk factors. The benefit of vericiguat did not differ significantly across the spectrum of risk in worsening HF.
Trial Registration


ClinicalTrials.gov Identifier: NCT02861534.",2021,"Vericiguat was associated with reduced risk of the primary outcome overall and in all subgroups, without evidence of treatment heterogeneity.","['Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) trial', '5050 patients in the VICTORIA trial, mean age was 67 years, 24% were women, 64% were White, 22% were Asian, and 5% were Black', 'patients with worsening chronic HF']","['placebo', 'HFH']","['time to a composite of HFH or cardiovascular death; secondary outcomes were time to HFH, cardiovascular death, a composite of all-cause mortality or HFH, all-cause death, and total HFH', 'Safety events (symptomatic hypotension and syncope']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}]",5050.0,0.243489,"Vericiguat was associated with reduced risk of the primary outcome overall and in all subgroups, without evidence of treatment heterogeneity.","[{'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore and Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Giczewska', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sliwa', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Edelmann', 'Affiliation': 'Charité University Medicine, German Heart Center, Berlin, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Refsgaard', 'Affiliation': 'Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Edimar', 'Initials': 'E', 'LastName': 'Bocchi', 'Affiliation': 'Instituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Merck and Co Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Charité University Medicine, German Heart Center, Berlin, Germany.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2020.6455']
200,33185670,"Association of Baseline Low-Density Lipoprotein Cholesterol and Percentage Low-Density Lipoprotein Cholesterol Reduction With Statins, Ezetimibe, and PCSK9 Inhibition.","Importance


Low-density lipoprotein cholesterol (LDL-C) is an important modifiable risk factor for atherosclerotic cardiovascular disease. It is unclear whether the percentage LDL-C lowering with pharmacotherapies differs on the basis of baseline LDL-C levels.
Objective


To evaluate the association between baseline LDL-C levels and the percentage LDL-C reduction with a statin, ezetimibe, and a PCSK9 inhibitor.
Design, Setting, and Participants


This secondary exploratory study analyzed data from 3 randomized placebo-controlled clinical trials (Aggrastat to Zocor-Thrombolysis in Myocardial Infarction 21 [A to Z-TIMI 21], Improved Reduction of Outcomes: Vytorin Efficacy International Trial [IMPROVE-IT], and Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk [FOURIER]) of lipid-lowering therapies (statin, ezetimibe, and a PCSK9 inhibitor) and included participants with atherosclerotic cardiovascular disease. Analyses took place form April to October 2020.
Interventions


In A to Z-TIMI 21, 1:1 randomization to simvastatin, 40 mg, daily for 30 days followed by 80 mg daily thereafter vs placebo for 4 months followed by simvastatin, 20 mg, daily thereafter. In IMPROVE-IT, 1:1 randomization to ezetimibe, 10 mg, daily plus simvastatin, 40 mg, daily vs placebo plus simvastatin, 40 mg, daily. In FOURIER, 1:1 randomization to evolocumab, 140 mg, every 2 weeks or 420 mg monthly vs matching placebo.
Main Outcomes and Measures


The percentage LDL-C reduction at either 1 month (A to Z-TIMI 21, IMPROVE-IT) or 3 months (FOURIER) as a function of baseline LDL-C level. Data were modeled using a generalized linear regression model.
Results


A total of 3187 patients from A to Z-TIMI 21, 10 680 patients from IMPROVE-IT, and 25 847 patients from FOURIER were analyzed. There was a higher percentage reduction in LDL-C levels with evolocumab in patients with lower baseline LDL-C levels, ranging from 59.4% (95% CI, 59.1%-59.8%) in patients with a baseline LDL-C level of 130 mg/dL to 66.1% (95% CI, 65.6%-66.6%) in patients with a baseline LDL-C level of 70 mg/dL (P < .001). In contrast, across the same range of baseline LDL-C level, there was a more modest difference for simvastatin (44.6% [95% CI, 43.9%-45.2%] vs 47.8% [95% CI, 46.4%-49.2%]; P < .001) and minimal difference with ezetimibe (25.0% [95% CI, 23.3%-26.6%] vs 26.2% [95% CI, 24.2%-28.1%]; P = .007).
Conclusions and Relevance


The percentage LDL-C reduction with statins, ezetimibe, and PCSK9 inhibition is not attenuated in patients starting with lower baseline LDL-C levels and is 6.6% greater for PCSK9 inhibition. These data are encouraging for the use of intensive LDL-C-lowering therapy even for patients with lower LDL-C levels.",2020,"There was a higher percentage reduction in LDL-C levels with evolocumab in patients with lower baseline LDL-C levels, ranging from 59.4% (95% CI, 59.1%-59.8%) in patients with a baseline LDL-C level of 130 mg/dL to 66.1% (95% CI, 65.6%-66.6%) in patients with a baseline LDL-C level of 70 mg/dL (P < .001).","['participants with atherosclerotic cardiovascular disease', 'Subjects With Elevated Risk', 'in Myocardial Infarction 21', '3187 patients from A to Z-TIMI 21, 10\u202f680 patients from IMPROVE-IT, and 25\u202f847 patients from FOURIER were analyzed']","['lipid-lowering therapies (statin, ezetimibe, and a PCSK9 inhibitor', 'Importance\n\n\nLow-density lipoprotein cholesterol (LDL-C', 'statin, ezetimibe, and a PCSK9 inhibitor', 'ezetimibe', 'placebo', 'placebo-controlled clinical trials (Aggrastat to Zocor-Thrombolysis', 'simvastatin', 'placebo\u2009plus\u2009simvastatin']","['LDL-C levels', 'Baseline Low-Density Lipoprotein Cholesterol and Percentage Low-Density Lipoprotein Cholesterol Reduction With Statins, Ezetimibe, and PCSK9 Inhibition', 'percentage LDL-C reduction', 'percentage LDL-C reduction with statins, ezetimibe, and PCSK9 inhibition']","[{'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C4521460', 'cui_str': 'PCSK9 inhibitor'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0656369', 'cui_str': 'Aggrastat'}, {'cui': 'C0678181', 'cui_str': 'Zocor'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1426592', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 gene'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",3187.0,0.394483,"There was a higher percentage reduction in LDL-C levels with evolocumab in patients with lower baseline LDL-C levels, ranging from 59.4% (95% CI, 59.1%-59.8%) in patients with a baseline LDL-C level of 130 mg/dL to 66.1% (95% CI, 65.6%-66.6%) in patients with a baseline LDL-C level of 70 mg/dL (P < .001).","[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Marcusa', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jeong-Gun', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'de Lemos', 'Affiliation': 'Cardiology Division, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2020.6184']
201,33200551,Shooting shots: Estimating alcoholic drink sizes in real life using event-level reports and annotations of close-up pictures.,"INTRODUCTION AND AIMS


Drinks consumed in real life are diverse, in terms of beverage type, container size and alcohol by volume. To date, most ecological momentary assessment studies have assessed drinking amounts with 'standard' drinks, although their event-level design allows for more advanced assessment schemes. The purpose of this empirical study is to compare participants' estimates of alcoholic drink characteristics, assessed using drink-specific questions, with estimates generated by annotators based on pictures of the same drinks.
DESIGN AND METHODS


On weekend nights, 186 young adults took 1484 close-up pictures of their drinks using a custom-built smartphone application. Participants reported the beverage type, drink size and alcohol by volume. Annotators described the beverage type, container size and filling level. Correspondence between participants' and annotators' estimates was explored using descriptive statistics, difference tests and correlations.
RESULTS


Annotators were unable to precisely identify the beverage types in most pictures of liqueurs, spirits and mixed drinks. Participants' drink size estimates converged with annotators' estimates of the container size for beer (41 cl corresponding to 16 g of pure alcohol) and mixed drinks (28 cl/35 g), and of the content size for wine (10 cl/9 g). However, annotators estimated larger sizes for liqueur/fortified wine (12 cl/14 g vs. 7 cl/9 g) and spirits (8 cl/26 g vs. 4 cl/10 g) than participants.
DISCUSSION AND CONCLUSIONS


Annotations of pictures should be considered as a complement to participants' reports rather than a substitute. Except for wine, real-life drinks vary largely and often exceed 10 g 'standard' drinks.",2021,"Participants' drink size estimates converged with annotators' estimates of the container size for beer (41 cl corresponding to 16 g of pure alcohol) and mixed drinks (28 cl/35 g), and of the content size for wine (10 cl/9 g).",['186 young adults took 1484 close-up pictures of their drinks using a custom-built smartphone application'],[],"['beverage type, drink size and alcohol by volume']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],"[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",186.0,0.0568818,"Participants' drink size estimates converged with annotators' estimates of the container size for beer (41 cl corresponding to 16 g of pure alcohol) and mixed drinks (28 cl/35 g), and of the content size for wine (10 cl/9 g).","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Labhart', 'Affiliation': 'Idiap Research Institute, Social Computing Group, Martigny, Switzerland.'}, {'ForeName': 'Thanh-Trung', 'Initials': 'TT', 'LastName': 'Phan', 'Affiliation': 'Idiap Research Institute, Social Computing Group, Martigny, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gatica-Perez', 'Affiliation': 'Idiap Research Institute, Social Computing Group, Martigny, Switzerland.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kuntsche', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Melbourne, Australia.'}]",Drug and alcohol review,['10.1111/dar.13212']
202,33181081,"Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST): a multicentre, prospective, randomised, open-label, non-inferiority trial.","BACKGROUND


Febuxostat and allopurinol are urate-lowering therapies used to treat patients with gout. Following concerns about the cardiovascular safety of febuxostat, the European Medicines Agency recommended a post-licensing study assessing the cardiovascular safety of febuxostat compared with allopurinol.
METHODS


We did a prospective, randomised, open-label, blinded-endpoint, non-inferiority trial of febuxostat versus allopurinol in patients with gout in the UK, Denmark, and Sweden. Eligible patients were 60 years or older, already receiving allopurinol, and had at least one additional cardiovascular risk factor. Those who had myocardial infarction or stroke in the previous 6 months or who had severe congestive heart failure or severe renal impairment were excluded. After a lead-in phase in which allopurinol dose was optimised towards achieving a serum urate concentration of less than 0·357 mmol/L (<6 mg/dL), patients were randomly assigned (1:1, with stratification according to previous cardiovascular events) to continue allopurinol (at the optimised dose) or start febuxostat at 80 mg/day, increasing to 120 mg/day if necessary to achieve the target serum urate concentration. The primary outcome was a composite of hospitalisation for non-fatal myocardial infarction or biomarker-positive acute coronary syndrome; non-fatal stroke; or cardiovascular death. The hazard ratio (HR) for febuxostat versus allopurinol in a Cox proportional hazards model (adjusted for the stratification variable and country) was assessed for non-inferiority (HR limit 1·3) in an on-treatment analysis. This study is registered with the EU Clinical Trials Register (EudraCT 2011-001883-23) and ISRCTN (ISRCTN72443728) and is now closed.
FINDINGS


From Dec 20, 2011, to Jan 26, 2018, 6128 patients (mean age 71·0 years [SD 6·4], 5225 [85·3%] men, 903 [14·7%] women, 2046 [33·4%] with previous cardiovascular disease) were enrolled and randomly allocated to receive allopurinol (n=3065) or febuxostat (n=3063). By the study end date (Dec 31, 2019), 189 (6·2%) patients in the febuxostat group and 169 (5·5%) in the allopurinol group withdrew from all follow-up. Median follow-up time was 1467 days (IQR 1029-2052) and median on-treatment follow-up was 1324 days (IQR 870-1919). For incidence of the primary endpoint, on-treatment, febuxostat (172 patients [1·72 events per 100 patient-years]) was non-inferior to allopurinol (241 patients [2·05 events per 100 patient-years]; adjusted HR 0·85 [95% CI 0·70-1·03], p<0·0001). In the febuxostat group, 222 (7·2%) of 3063 patients died and 1720 (57·3%) of 3001 in the safety analysis set had at least one serious adverse event (with 23 events in 19 [0·6%] patients related to treatment). In the allopurinol group, 263 (8·6%) of 3065 patients died and 1812 (59·4%) of 3050 had one or more serious adverse events (with five events in five [0·2%] patients related to treatment). Randomised therapy was discontinued in 973 (32·4%) patients in the febuxostat group and 503 (16·5%) patients in the allopurinol group.
INTERPRETATION


Febuxostat is non-inferior to allopurinol therapy with respect to the primary cardiovascular endpoint, and its long-term use is not associated with an increased risk of death or serious adverse events compared with allopurinol.
FUNDING


Menarini, Ipsen, and Teijin Pharma Ltd.",2020,The primary outcome was a composite of hospitalisation for non-fatal myocardial infarction or biomarker-positive acute coronary syndrome; non-fatal stroke; or cardiovascular death.,"['973 (32·4%) patients in the febuxostat group and 503 (16·5%) patients in the allopurinol group', 'Eligible patients were 60 years or older, already receiving allopurinol, and had at least one additional cardiovascular risk factor', 'Those who had myocardial infarction or stroke in the previous 6 months or who had severe congestive heart failure or severe renal impairment were excluded', '241 patients [2·05 events per 100 patient-years]; adjusted HR 0·85', 'patients with gout', 'patients with gout (FAST', 'patients with gout in the UK, Denmark, and Sweden', 'From Dec 20, 2011, to Jan 26, 2018, 6128 patients (mean age 71·0 years [SD 6·4], 5225 [85·3%] men, 903 [14·7%] women, 2046 [33·4%] with previous cardiovascular disease']","['start febuxostat', 'allopurinol (n=3065) or febuxostat', 'febuxostat versus allopurinol', 'febuxostat', 'allopurinol', 'Febuxostat and allopurinol']","['cardiovascular safety', 'composite of hospitalisation for non-fatal myocardial infarction or biomarker-positive acute coronary syndrome; non-fatal stroke; or cardiovascular death', 'hazard ratio (HR', 'serious adverse event', 'serum urate concentration', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",6128.0,0.255384,The primary outcome was a composite of hospitalisation for non-fatal myocardial infarction or biomarker-positive acute coronary syndrome; non-fatal stroke; or cardiovascular death.,"[{'ForeName': 'Isla S', 'Initials': 'IS', 'LastName': 'Mackenzie', 'Affiliation': 'MEMO Research, Division of Molecular and Clinical Medicine, University of Dundee, Dundee, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'The Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Nuki', 'Affiliation': 'Centre for Genomic and Experimental Medicine, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Hallas', 'Affiliation': 'University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hawkey', 'Affiliation': 'Nottingham Digestive Diseases Centre, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Webster', 'Affiliation': 'Clinical Pharmacology Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Ralston', 'Affiliation': 'Molecular Medicine Centre, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Walters', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': 'The Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': ""University of Pisa, Pisa University Hospital, and Fondazione VillaSerena per la Ricerca, CittàSant'Angelo, Pescara, Italy.""}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Findlay', 'Affiliation': 'MEMO Research, Division of Molecular and Clinical Medicine, University of Dundee, Dundee, UK.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Perez-Ruiz', 'Affiliation': 'Osakidetza, OSI EE-Cruces, Cruces University Hospital-Rheumatology Division, Biskay, Spain.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'MacDonald', 'Affiliation': 'MEMO Research, Division of Molecular and Clinical Medicine, University of Dundee, Dundee, UK. Electronic address: t.m.macdonald@dundee.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32234-0']
203,33188417,Minor Changes in the Composition and Function of the Gut Microbiota During a 12-Week Whole Grain Wheat or Refined Wheat Intervention Correlate with Liver Fat in Overweight and Obese Adults.,"BACKGROUND


Whole grain wheat (WGW) products are advocated as a healthy choice when compared with refined wheat (RW). One proposed mechanism for these health benefits is via the microbiota, because WGW contains multiple fibers. WGW consumption has been proposed to ameliorate nonalcoholic fatty liver disease, in which microbiota might play a role.
OBJECTIVES


We investigated the effect of WGW compared with RW intervention on the fecal microbiota composition and functionality, and correlated intervention-induced changes in bacteria with changes in liver health parameters in adults with overweight or obesity.
METHODS


We used data of a 12-wk double-blind, randomized, controlled, parallel trial to examine the effects of a WGW (98 g/d) or RW (98 g/d) intervention on the secondary outcomes fecal microbiota composition, predicted microbiota functionality, and stool consistency in 37 women and men (aged 45-70 y, BMI 25-35 kg/m2). The changes in microbiota composition, measured using 16S ribosomal RNA gene sequencing, after a 12-wk intervention were analyzed with nonparametric tests, and correlated with changes in liver fat and circulating concentrations of liver enzymes including alanine transaminase, aspartate transaminase, γ-glutamyltransferase, and serum amyloid A.
RESULTS


The WGW intervention increased the mean (± SD) relative abundances of Ruminococcaceae_UCG-014 (baseline: 2.2 ± 4.6%, differential change over time (Δ) 0.51 ± 4.2%), Ruminiclostridium_9 (baseline: 0.065 ± 0.11%, Δ 0.054 ± 0.14%), and Ruminococcaceae_NK4A214_group (baseline: 0.37 ± 0.56%, Δ 0.17 ± 0.83%), and also the predicted pathway acetyl-CoA fermentation to butyrate II (baseline: 0.23 ± 0.062%, Δ 0.035 ± 0.059%), compared with the RW intervention (P values <0.05). A change in Ruminococcaceae_NK4A214_group was positively correlated with the change in liver fat, in both the WGW (ρ = 0.54; P = 0.026) and RW (ρ = 0.67; P = 0.024) groups.
CONCLUSIONS


In middle-aged overweight and obese adults, a 12-wk WGW intervention increased the relative abundance of a number of bacterial taxa from the family Ruminococcaceae and increased predicted fermentation pathways when compared with an RW intervention. Potential protective health effects of replacement of RW by WGW on metabolic organs, such as the liver, via modulation of the microbiota, deserve further investigation.This trial was registered at clinicaltrials.gov as NCT02385149.",2021,"The WGW intervention increased the mean (± SD) relative abundances of Ruminococcaceae_UCG-014 (baseline: 2.2 ± 4.6%, differential change over time (Δ) 0.51 ± 4.2%), Ruminiclostridium_9 (baseline: 0.065 ± 0.11%, Δ 0.054 ± 0.14%), and Ruminococcaceae_NK4A214_group (baseline: 0.37 ± 0.56%, Δ 0.17 ± 0.83%), and also the predicted pathway acetyl-CoA fermentation to butyrate II (baseline: 0.23 ± 0.062%, Δ 0.035 ± 0.059%), compared with the RW intervention (P values <0.05).","['adults with overweight or obesity', '37 women and men (aged 45-70 y, BMI 25-35 kg/m2', 'Overweight and Obese Adults', 'middle-aged overweight and obese adults']","['WGW (98\xa0g/d) or RW (98\xa0g/d) intervention', 'WGW', 'Grain Wheat or Refined Wheat Intervention', 'RW intervention']","['mean (± SD) relative abundances of Ruminococcaceae_UCG-014', 'Composition and Function of the Gut Microbiota', 'fecal microbiota composition and functionality', 'liver fat and circulating concentrations of liver enzymes including alanine transaminase, aspartate transaminase, γ-glutamyltransferase, and serum amyloid A', 'change in liver fat']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",37.0,0.125428,"The WGW intervention increased the mean (± SD) relative abundances of Ruminococcaceae_UCG-014 (baseline: 2.2 ± 4.6%, differential change over time (Δ) 0.51 ± 4.2%), Ruminiclostridium_9 (baseline: 0.065 ± 0.11%, Δ 0.054 ± 0.14%), and Ruminococcaceae_NK4A214_group (baseline: 0.37 ± 0.56%, Δ 0.17 ± 0.83%), and also the predicted pathway acetyl-CoA fermentation to butyrate II (baseline: 0.23 ± 0.062%, Δ 0.035 ± 0.059%), compared with the RW intervention (P values <0.05).","[{'ForeName': 'Mara P H', 'Initials': 'MPH', 'LastName': 'van Trijp', 'Affiliation': 'Nutrition, Metabolism & Genomics Group, Division of Human Nutrition and Health, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schutte', 'Affiliation': 'Nutrition, Metabolism & Genomics Group, Division of Human Nutrition and Health, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Esser', 'Affiliation': 'Nutrition, Metabolism & Genomics Group, Division of Human Nutrition and Health, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Wopereis', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, The Netherlands.'}, {'ForeName': 'Femke P M', 'Initials': 'FPM', 'LastName': 'Hoevenaars', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, The Netherlands.'}, {'ForeName': 'Guido J E J', 'Initials': 'GJEJ', 'LastName': 'Hooiveld', 'Affiliation': 'Nutrition, Metabolism & Genomics Group, Division of Human Nutrition and Health, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Lydia A', 'Initials': 'LA', 'LastName': 'Afman', 'Affiliation': 'Nutrition, Metabolism & Genomics Group, Division of Human Nutrition and Health, Wageningen University, Wageningen, The Netherlands.'}]",The Journal of nutrition,['10.1093/jn/nxaa312']
204,33200413,Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial.,"OBJECTIVE


Scalable, accessible forms of behavioral therapy for migraine prevention are needed. We assessed the feasibility and acceptability of progressive muscle relaxation (PMR) delivered by a smartphone application (app) in the Primary Care setting.
METHODS


This pilot study was a non-blinded, randomized, parallel-arm controlled trial of adults with migraine and 4+ headache days/month. Eligible participants spoke English and owned a smartphone. All participants were given the RELAXaHEAD app which includes an electronic headache diary. Participants were randomized to receive 1 of the 2 versions of the app-one with PMR and the other without PMR. The primary outcomes were measures of feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels). We conducted exploratory analyses to determine whether there was a change in Migraine Disability Assessment Scale (MIDAS) scores or a change in headache days.
RESULTS


Of 139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7 ± 12.8 years. Most patients 108/139 (78%) had moderate-severe disability. Using a 1-5 Likert scale, participants found the app easy to use (mean 4.2 ± 0.7) and stated that they would be happy to engage in the PMR intervention again (mean 4.3 ± 0.6). For the first 6 weeks, participants practiced PMR 2-4 days/week. Mean per session duration was 11.1 ± 8.3 minutes. Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38).
CONCLUSION


Smartphone-delivered PMR may be an acceptable, accessible form of therapy for migraine. Mean effects show a small-moderate mean effect size in disability scores.",2020,"Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38).
","['Eligible participants spoke English and owned a smartphone', 'adults with migraine and 4+ headache days/month', '139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7\xa0±\xa012.8 years', 'Migraine in Primary Care']","['RELAXaHEAD', 'Smartphone-Delivered Progressive Muscle Relaxation', 'PMR and the other without PMR', 'progressive muscle relaxation (PMR) delivered by a smartphone application (app']","['disability scores', 'moderate-severe disability', 'feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels', 'mean MIDAS scores', 'Migraine Disability Assessment Scale (MIDAS) scores']","[{'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}]",139.0,0.0933415,"Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38).
","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Samrachana', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Padikkala', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Sumaiya', 'Initials': 'S', 'LastName': 'Tasneem', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Bagheri', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine Faculty Group Practices, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Powers', 'Affiliation': ""Behavioral Medicine, Headache Medicine, Clinical Psychology, Cincinnati Children's Hospital, Cincinnati, OH, USA.""}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Montefiore Headache Center, Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA.'}]",Headache,['10.1111/head.14010']
205,33163109,Gaming Console Home-Based Exercise for Adults with Cystic Fibrosis: Study Protocol.,"Background


Despite evidence of exercise benefits to lung function, adherence to routine exercise in adults with cystic fibrosis (CF) is low. The incorporation of interactive virtual reality video exergame activities in home-based programs as an incentive may help improve motivation and adherence to exercise. This proposed study will attempt to improve the physical fitness and respiratory function of sedentary adults with CF by engaging them in a Nintendo Wii Fit Plus™ home-based exercise program.
Methods


A single group pretest-posttest design will be used to examine the immediate (12-weeks) and long-term effect (24-weeks) of a home-based exergame program on improving pulmonary-related function (physical fitness and respiratory function) in sedentary adults with CF. Participants will receive a one-time orientation to the Wii Fit Plus, and will be requested to use it to exercise according to the recommended guidelines 3 times a week for 30 min in the following 24 weeks. Monthly phone monitoring will be conducted during the first 12 weeks. Besides evaluating the efficacy of a home-based exergame program on improving aerobic capacity, physical activity, and respiratory-related symptoms, we will examine the impact of the exergame on airway ion transport as measured by nasal potential difference, which will be collected at baseline and at the end of 12-weeks only.
Discussion


This is the first study to evaluate the feasibility, acceptability and potential effectiveness of a low-cost exercise avenue (i.e., exergames) for adults with CF to improve their pulmonary-related function, which is important for CF disease management and prevention of complications. In addition, the proposed study will be the first to investigate the therapeutic efficacy of home-based exergames on airway ion transport among adults with CF. Through an increase in physical activity, it is expected that participants will improve their physical fitness and respiratory function at the end of the study.
Trial registration


ClinicalTrials.gov ID: NCT02277860.",2020,"Besides evaluating the efficacy of a home-based exergame program on improving aerobic capacity, physical activity, and respiratory-related symptoms, we will examine the impact of the exergame on airway ion transport as measured by nasal potential difference, which will be collected at baseline and at the end of 12-weeks only.
","['Adults with Cystic Fibrosis', 'adults with cystic fibrosis (CF', 'sedentary adults with CF by engaging them in a Nintendo Wii Fit Plus™ home-based exercise program', 'adults with CF', 'sedentary adults with CF']","['low-cost exercise', 'home-based exergame program', 'Gaming Console Home-Based Exercise']","['aerobic capacity, physical activity, and respiratory-related symptoms', 'pulmonary-related function (physical fitness and respiratory function', 'physical activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3873699', 'cui_str': 'Console'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",,0.0380311,"Besides evaluating the efficacy of a home-based exergame program on improving aerobic capacity, physical activity, and respiratory-related symptoms, we will examine the impact of the exergame on airway ion transport as measured by nasal potential difference, which will be collected at baseline and at the end of 12-weeks only.
","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Lowman', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, and the Gregory Fleming James Cystic Fibrosis Research Center, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Solomon', 'Affiliation': 'Department of Medicine and the Gregory Fleming James Cystic Fibrosis Research Center, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': 'Departments of Medicine, Pediatrics, and Cell Developmental and Integrative Biology; Gregory Fleming James Cystic Fibrosis Research Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Hon K', 'Initials': 'HK', 'LastName': 'Yuen', 'Affiliation': 'Department of Occupational Therapy, School of Health Professions, University of Alabama at Birmingham, 1720 2nd Ave S, Birmingham, AL, USA.'}]",International journal of caring sciences,[]
206,33188693,"Global Phase 3 programme of vadadustat for treatment of anaemia of chronic kidney disease: rationale, study design and baseline characteristics of dialysis-dependent patients in the INNO2VATE trials.","BACKGROUND


Erythropoiesis-stimulating agents (ESAs) are currently the mainstay of treatment for anaemia of chronic kidney disease (CKD). Vadadustat is an investigational oral hypoxia-inducible factor prolyl-hydroxylase inhibitor that stimulates endogenous erythropoietin formation. The INNO2VATE programme comprises two studies designed to evaluate the safety and efficacy of vadadustat versus the ESA darbepoetin alfa in ameliorating anaemia in patients with dialysis-dependent CKD (DD-CKD). Here we describe the trial design along with patient demographics and baseline characteristics.
METHODS


Two Phase 3, open-label, sponsor-blind, active-controlled trials enrolled adults with anaemia of CKD who recently initiated dialysis and had limited ESA exposure (incident DD-CKD trial) or were receiving maintenance dialysis with ESA treatment (prevalent DD-CKD trial). Study periods include correction/conversion (Weeks 0-23), maintenance (Weeks 24-52), long-term treatment (Weeks 53 to end of treatment) and safety follow-up. The primary safety endpoint is the time to the first major adverse cardiovascular event and the primary efficacy endpoint is the change in haemoglobin (baseline to Weeks 24-36).
RESULTS


A total of 369 and 3554 patients were randomized in the incident DD-CKD and prevalent DD-CKD trials, respectively. Demographics and baseline characteristics were similar among patients in both trials and comparable to those typically observed in DD-CKD.
CONCLUSIONS


The two INNO2VATE trials will provide important information on the safety and efficacy of a novel approach for anaemia management in a diverse DD-CKD population. Demographics and baseline characteristics of enrolled patients suggest that study results will be representative for a large proportion of the DD-CKD population.",2021,"A total of 369 and 3554 patients were randomized in the incident DD-CKD and prevalent DD-CKD trials, respectively.","['Two Phase 3, open-label, sponsor-blind, active-controlled trials enrolled adults with anaemia of CKD who recently initiated dialysis and had limited ESA exposure (incident DD-CKD trial) or were receiving maintenance dialysis with ESA treatment (prevalent DD-CKD trial', 'dialysis-dependent patients in the INNO2VATE trials', 'anaemia of chronic kidney disease', 'A total of 369 and 3554 patients', 'anaemia of chronic kidney disease (CKD', 'patients with dialysis-dependent CKD (DD-CKD']","['ESA darbepoetin alfa', 'Erythropoiesis-stimulating agents (ESAs']","['time to the first major adverse cardiovascular event and the primary efficacy endpoint is the change in haemoglobin', 'safety and efficacy']","[{'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3554.0,0.137447,"A total of 369 and 3554 patients were randomized in the incident DD-CKD and prevalent DD-CKD trials, respectively.","[{'ForeName': 'Kai-Uwe', 'Initials': 'KU', 'LastName': 'Eckardt', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medicine Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Youssef Mk', 'Initials': 'YM', 'LastName': 'Farag', 'Affiliation': 'Akebia Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Jardine', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Khawaja', 'Affiliation': 'Akebia Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Koury', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Akebia Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Matsushita', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'McCullough', 'Affiliation': 'Department of Internal Medicine, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Parfrey', 'Affiliation': ""Department of Medicine, Memorial University, St John's, Newfoundland, Canada.""}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Ross', 'Affiliation': 'Akebia Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology, Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Vargo', 'Affiliation': 'Akebia Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Wolfgang C', 'Initials': 'WC', 'LastName': 'Winkelmayer', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa204']
207,33196779,Early Treatment Improvements in Depression Are Associated With Overall Improvements in Fatigue Impact and Pain Interference in Adults With Multiple Sclerosis.,"BACKGROUND


Depression, fatigue, and pain commonly co-occur in multiple sclerosis (MS) and are positively associated with one another. However, it is unclear whether treatment-related improvement in one of these symptoms is associated with improvements in the other two symptoms.
PURPOSE


This study examined whether early improvements in depressive symptoms, fatigue impact, and pain interference during a multisymptom intervention in persons with MS were associated with overall improvements in the other two symptoms.
METHODS


Secondary analysis of a randomized controlled trial in which both treatments improved depressive symptoms, fatigue, and pain interference. Adults with MS experiencing chronic pain, chronic fatigue, and/or moderate depressive symptoms (N = 154, 86% women) participated in an 8-week, telephone-delivered intervention: self-management (n = 69) or education (n = 85); intervention groups were combined for the current study. Outcome measures were depressive symptoms (PHQ-9), fatigue impact (Modified Fatigue Impact Scale), and pain interference (Brief Pain Inventory). Path analysis examined associations between pre-to-mid intervention improvement in one symptom (i.e., depression, fatigue, pain interference) and pre-to-post (overall) improvement in the other two symptoms.
RESULTS


Early reduction in depressive symptoms was associated with an overall reduction in pain interference and fatigue impact (p's < .01). Early reduction in fatigue impact was associated with an overall reduction in depressive symptom severity (p = .04) but not pain interference. Early reduction in pain interference was not associated with reductions in fatigue impact or depressive symptoms.
CONCLUSIONS


These findings suggest the potential importance of reducing depressive symptoms to overall improvement in fatigue and pain interference in persons with MS.
CLINICAL TRIAL REGISTRATIONS


NCT00944190.",2021,Early reduction in depressive symptoms was associated with an overall reduction in pain interference and fatigue impact (p's < .01).,"['persons with MS', 'Adults with MS experiencing chronic pain, chronic fatigue, and/or moderate depressive symptoms (N = 154, 86% women) participated in an 8-week', 'Adults With Multiple Sclerosis']",['telephone-delivered intervention: self-management (n = 69) or education'],"['depressive symptom severity', 'depressive symptoms (PHQ-9), fatigue impact (Modified Fatigue Impact Scale), and pain interference (Brief Pain Inventory', 'fatigue impact or depressive symptoms', 'depressive symptoms, fatigue, and pain interference', 'Fatigue Impact and Pain Interference', 'fatigue impact', 'fatigue and pain interference', 'depressive symptoms, fatigue impact, and pain interference', 'pain interference and fatigue impact', 'depressive symptoms', 'pain interference', 'one symptom (i.e., depression, fatigue, pain interference) and pre-to-post (overall) improvement']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",154.0,0.0861724,Early reduction in depressive symptoms was associated with an overall reduction in pain interference and fatigue impact (p's < .01).,"[{'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Knowles', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Arewasikporn', 'Affiliation': 'Department of Epidemiology, University of Washington School of Public Health, Seattle, WA, USA.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Kratz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Aaron P', 'Initials': 'AP', 'LastName': 'Turner', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Alschuler', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa102']
208,33207259,"Risk of Inflammation, Retinal Vasculitis, and Retinal Occlusion-Related Events with Brolucizumab: Post Hoc Review of HAWK and HARRIER.","PURPOSE


An independent Safety Review Committee (SRC), supported by Novartis Pharma AG, analyzed investigator-reported cases of intraocular inflammation (IOI), endophthalmitis, and retinal arterial occlusion in the phase 3 HAWK and HARRIER trials of brolucizumab versus aflibercept in neovascular age-related macular degeneration (nAMD).
DESIGN


A post hoc analysis of a subset of data from two 2-year, double-masked, multicenter, active-controlled randomized phase 3 trials (NCT02307682, NCT02434328).
PARTICIPANTS


Patients (N = 1817) with untreated, active choroidal neovascularization due to age-related macular degeneration in the study eye were randomized and treated in HAWK/HARRIER. The SRC reviewed data from cases of investigator-reported IOI (60/1088 brolucizumab-treated eyes; 8/729 aflibercept-treated eyes).
METHODS


The SRC received details and images (color fundus photography, fluorescein angiography, and OCT) for all investigator-determined cases of IOI, retinal arterial occlusion, and endophthalmitis. Cases were reviewed in detail by ≥2 readers, then adjudicated by the SRC as a group.
MAIN OUTCOME MEASURES


Within this patient subset: incidence of IOI, signs and incidence of retinal vasculitis and/or retinal vascular occlusion, and visual acuity loss; time since first brolucizumab injection to IOI event onset; and frequency of visual acuity loss after brolucizumab injection by time of first IOI event onset.
RESULTS


Fifty brolucizumab-treated eyes were considered to have definite/probable drug-related events within the spectrum of IOI, retinal vasculitis, and/or vascular occlusion. On the basis of these cases, incidence of definite/probable IOI was 4.6% (IOI + vasculitis, 3.3%; IOI + vasculitis + occlusion, 2.1%). There were 8 cases (incidence 0.74%) of at least moderate visual acuity loss (≥15 ETDRS letters) in eyes with IOI (7 in eyes with IOI + vasculitis + occlusion). Of the 8 cases, 5 experienced their first IOI-related event within 3 months of the first brolucizumab injection (increasing to 7/8 within 6 months). Incidence of IOI in aflibercept-treated eyes was 1.1%, with at least moderate visual acuity loss in 0.14%.
CONCLUSIONS


This analysis of IOI cases after brolucizumab injection identified signs of retinal vasculitis with or without retinal vascular occlusion and an associated risk of visual acuity loss. The findings will help physicians to evaluate the risks and benefits of brolucizumab treatment for nAMD.",2021,"This analysis of IOI cases following brolucizumab injection identified signs of retinal vasculitis with or without retinal vascular occlusion, and an associated risk of visual acuity loss.","['Patients (N=1817) with untreated, active choroidal neovascularization due to AMD in the study eye', 'neovascular age-related macular degeneration (nAMD']","['brolucizumab', 'brolucizumab injection', 'brolucizumab versus aflibercept']","['Incidence of IOI', 'visual acuity loss', 'Risk of inflammation, retinal vasculitis and retinal occlusion', 'incidence of definite/probable IOI', 'IOI, signs and incidence of retinal vasculitis and/or retinal vascular occlusion, and visual acuity loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}]","[{'cui': 'C4550124', 'cui_str': 'brolucizumab'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0234632', 'cui_str': 'Reduced visual acuity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0152026', 'cui_str': 'Retinal vasculitis'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0035326', 'cui_str': 'Retinal vascular occlusion'}]",1817.0,0.203461,"This analysis of IOI cases following brolucizumab injection identified signs of retinal vasculitis with or without retinal vascular occlusion, and an associated risk of visual acuity loss.","[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Monés', 'Affiliation': 'Institut de la Màcula, Barcelona, Spain, Barcelona Macula Foundation, Barcelona, Spain.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Srivastava', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tadayoni', 'Affiliation': 'Departement Hospitalo-Universitaire Vision et Handicaps, Paris, France; Université de Paris, Ophthalmology Department, AP-HP, Hôpital Lariboisière, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Albini', 'Affiliation': 'Bascom Palmer Eye Institute, The University of Miami, Miami, Florida.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Kaiser', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Korobelnik', 'Affiliation': ""CHU Bordeaux, Service d'ophtalmologie, Bordeaux, France; University Bordeaux, INSERM, BPH, Bordeaux, France.""}, {'ForeName': 'Ivana K', 'Initials': 'IK', 'LastName': 'Kim', 'Affiliation': 'Dr. Kim participated in this study as a consultant to Novartis independent of her faculty appointment in the Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pruente', 'Affiliation': 'Department of Ophthalmology, University of Basel, Basel, Switzerland; Department of Ophthalmology, Kantonsspital Baselland, Liestal, Switzerland; Institute of Molecular and Clinical Ophthalmology Basel (IOB), Basel, Switzerland.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Murray', 'Affiliation': 'Murray Ocular Oncology and Retina, Miami, Florida.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts. Electronic address: jsheier@eyeboston.com.'}]",Ophthalmology,['10.1016/j.ophtha.2020.11.011']
209,33165938,Eptinezumab Demonstrated Efficacy in Sustained Prevention of Episodic and Chronic Migraine Beginning on Day 1 After Dosing.,"OBJECTIVE


To determine the onset of preventive efficacy with eptinezumab in patients with migraine.
BACKGROUND


Eptinezumab is a monoclonal antibody inhibiting calcitonin gene-related peptide approved as an intravenously administered treatment for the prevention of migraine.
METHODS


Patients who received eptinezumab 100 mg, eptinezumab 300 mg, or placebo in PROMISE7-1 (episodic migraine; 100 mg, n = 221; 300 mg, n = 222; placebo, n = 222) or PROMISE7-2 (chronic migraine; 100 mg, n = 356; 300 mg, n = 350; placebo, n = 366) were included. Testing of the percentage of patients with a migraine on day 1 after dosing was prespecified and alpha-controlled. In further exploration of this prespecified endpoint, a post hoc closed testing procedure, which controlled the false-positive (type 1) error rate, provided a statistically rigorous evaluation of migraine prevention onset. The procedure involved up to 84 tests of significance, all of which were performed in sequence until the first nonsignificant result.
RESULTS


For both studies, all tests for significance for eptinezumab 100 and 300 mg, from days 1-84 through day 1 alone, achieved nominal significance (P < .05), indicating that eptinezumab was fully effective beginning on day 1. Over each interval, the treatment effect was comparable to the effect over weeks 1-12. Mean changes from baseline in monthly migraine days for the primary endpoint period ranged from -3.9 to -4.9, -4.1 to -4.9, and -2.2 to -3.2 for eptinezumab 100, 300 mg, and placebo, respectively, in PROMISE7-1 and from -7.2 to -8.0, -7.9 to -8.2, and -4.3 to -5.6, respectively, in PROMISE7-2. The difference from placebo (95% confidence interval) in day 1 treatment effect was -2.2 (-4.1, -0.3) and -2.5 (-4.4, -0.6) days/month for eptinezumab 100 and 300 mg, respectively, in PROMISE7-1, and was -3.8 (-5.6, -2.0) and -4.0 (-5.8, -2.1) days/month for 100 and 300 mg, respectively, in PROMISE7-2.
CONCLUSIONS


The migraine preventive effect of eptinezumab is rapid and sustained in patients with episodic or chronic migraine, with onset of optimal preventive efficacy observed on the day following the initial dose.",2020,"The difference from placebo (95% confidence interval) in day 1 treatment effect was -2.2 (-4.1, -0.3) and -2.5 (-4.4, -0.6) days/month for eptinezumab 100 and 300 mg, respectively, in PROMISE-1, and was -3.8 (-5.6, -2.0) and -4.0 (-5.8, -2.1) days/month for 100 and 300 mg, respectively, in PROMISE-2.
","['Patients who received', 'patients with migraine', 'patients with episodic or chronic migraine']","['placebo', 'eptinezumab 100\xa0mg, eptinezumab 300\xa0mg, or placebo in PROMISE-1 (episodic migraine; 100\xa0mg, n\xa0=\xa0221; 300\xa0mg, n\xa0=\xa0222; placebo, n\xa0=\xa0222) or PROMISE-2 (chronic migraine; 100\xa0mg, n\xa0=\xa0356; 300\xa0mg, n\xa0=\xa0350; placebo', 'eptinezumab']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4694272', 'cui_str': 'eptinezumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4517735', 'cui_str': '350'}]",[],366.0,0.120811,"The difference from placebo (95% confidence interval) in day 1 treatment effect was -2.2 (-4.1, -0.3) and -2.5 (-4.4, -0.6) days/month for eptinezumab 100 and 300 mg, respectively, in PROMISE-1, and was -3.8 (-5.6, -2.0) and -4.0 (-5.8, -2.1) days/month for 100 and 300 mg, respectively, in PROMISE-2.
","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic Arizona, Mayo Clinic Arizona, Scottsdale, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gottschalk', 'Affiliation': 'Yale Neurology, New Haven, CT, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hirman', 'Affiliation': 'Pacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Snapinn', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}]",Headache,['10.1111/head.14007']
210,33174080,Benefit-Risk or Risk-Benefit Trade-Offs? Another Look at Attribute Ordering Effects in a Pilot Choice Experiment.,"BACKGROUND


Studies recommend randomising the order of attributes in discrete choice experiments (DCEs) to avoid bias; however, in a benefit-risk setting, this may increase the cognitive burden of respondents who compare the benefits and risks of treatments, or may affect their decision-making process. Based on these concerns, this paper explored attribute ordering effects in a benefit-risk DCE.
METHOD


Attribute ordering effects were explored in a large pilot DCE relating to the medical treatment of insomnia. Participants were randomised to one of three presentation orders: (1) benefits were presented before risks (BR); (2) risks were presented before benefits (RB); (3) all attributes were randomised (RN). For the RB and BR presentation orders, attributes were randomised within benefits and risks. Responses were assessed in three ways. First, variations in respondents' self-reported choice certainty were obtained. Second, variations in failure rates of stability and dominance tests were calculated. Third, a heteroscedastic error component model tested for differences in choice consistency across the three attribute orderings.
RESULTS


The final analysis included 156 respondents (RN: 54; BR: 49; RB: 53). No differences were found between the presentation orders with respect to stated choice certainty, or the proportion of respondents failing either the dominance or stability test. However, deterministic attribute grouping was associated with higher choice consistency.
CONCLUSION


To increase choice consistency, DCE attributes should be randomised within logical groups that may be further randomised to reduce the risk of ordering effects.",2021,"No differences were found between the presentation orders with respect to stated choice certainty, or the proportion of respondents failing either the dominance or stability test.",[],[],['failure rates of stability and dominance tests'],[],[],"[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",156.0,0.0632265,"No differences were found between the presentation orders with respect to stated choice certainty, or the proportion of respondents failing either the dominance or stability test.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Heidenreich', 'Affiliation': 'Evidera Inc., London, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Phillips-Beyer', 'Affiliation': 'Innovus Consulting, London, UK. innovusconsultingltd@gmail.com.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Flamion', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Ross', 'Affiliation': 'Evidera Inc., London, UK.'}, {'ForeName': 'Jaein', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Evidera Inc., London, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Marsh', 'Affiliation': 'Evidera Inc., London, UK.'}]",The patient,['10.1007/s40271-020-00475-y']
211,33179323,Reversion From Chronic Migraine to Episodic Migraine in Patients Treated With Fremanezumab: Post Hoc Analysis From HALO CM Study.,"BACKGROUND


Migraine preventive medications are used to reduce headache frequency, severity, and duration. In patients with chronic migraine (CM), reversion to episodic migraine (EM) is an important treatment goal.
OBJECTIVE


To evaluate the effect of fremanezumab on the rate of reversion from CM to EM.
METHODS


This phase 3, randomized, double-blind, placebo-controlled, parallel-group trial included a 28-day pretreatment period and a 3-month treatment period. Patients with CM received subcutaneous fremanezumab quarterly (675 mg at baseline) or monthly (675 mg at baseline; 225 mg at Weeks 4 and 8), or placebo. Post hoc analyses evaluated the proportion of patients who reverted from CM to EM, defined as either a reduction to an average of <15 headache days per month during the 3-month treatment period or a reduction to <15 headache days per month in all 3 months of the treatment period.
RESULTS


This analysis included data from 1088 CM patients (quarterly, n = 366; monthly, n = 365; placebo, n = 357). More fremanezumab-treated patients with CM reverted to EM using either the monthly average number of headache days criteria for reversion (quarterly: 50.5% [185/366], P = .108; monthly: 53.7% [196/365], P = .012; vs placebo: 44.5% [159/357]) or the monthly headache day count at Months 1, 2, and 3 criteria for reversion (quarterly: 31.2% [114/366], P = .008; monthly: 33.7% [123/365], P = .001; vs placebo: 22.4% [80/357]). Patients with CM who reported previous topiramate or onabotulinumtoxinA use, concomitant preventive medication use, or medication overuse were less likely to revert to EM.
CONCLUSIONS


Fremanezumab may offer the benefit of reversion from CM to EM, based on a reduction in the number of headache days over 3 months of treatment.",2020,"More fremanezumab-treated patients with CM reverted to EM using either the monthly average number of headache days criteria for reversion (quarterly: 50.5% [185/366], P = .108; monthly: 53.7% [196/365], P = .012; vs placebo: 44.5% [159/357]) or the monthly headache day count at Months 1, 2, and 3 criteria for reversion (quarterly: 31.2% [114/366], P = .008; monthly: 33.7% [123/365], P = .001; vs placebo: 22.4% [80/357]).","['patients with chronic migraine (CM), reversion to episodic migraine (EM', '1088 CM patients (quarterly, n\xa0=\xa0366; monthly, n\xa0=\xa0365; placebo, n\xa0=\xa0357', 'Patients with CM who reported previous topiramate or onabotulinumtoxinA use, concomitant preventive medication use, or medication overuse were less likely to revert to EM', 'Patients']","['Fremanezumab', 'placebo', 'fremanezumab', 'subcutaneous fremanezumab']",['monthly headache day count'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3266697', 'cui_str': 'Medication overuse'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.19887,"More fremanezumab-treated patients with CM reverted to EM using either the monthly average number of headache days criteria for reversion (quarterly: 50.5% [185/366], P = .108; monthly: 53.7% [196/365], P = .012; vs placebo: 44.5% [159/357]) or the monthly headache day count at Months 1, 2, and 3 criteria for reversion (quarterly: 31.2% [114/366], P = .008; monthly: 33.7% [123/365], P = .001; vs placebo: 22.4% [80/357]).","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Bibeau', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Galic', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Amsterdam, The Netherlands.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Seminerio', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Ramirez Campos', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Rashmi B', 'Initials': 'RB', 'LastName': 'Halker Singh', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'MedStar Georgetown University Hospital, Washington, DC, USA.'}]",Headache,['10.1111/head.13997']
212,33184667,Feasibility of using a peer coach to deliver a behavioral intervention for promoting postpartum weight loss in Black and Latina mothers.,"Peer coaching may provide a culturally relevant and potentially scalable approach for delivering postpartum obesity treatment. We aimed to evaluate the feasibility of peer coaching to promote postpartum weight loss among ethnic minority women with obesity. This pilot study was a prospective, parallel-arm, randomized controlled trial. Twenty-two obese, Black or Latina mothers ≤6 months postpartum were recruited from the Philadelphia Special Supplemental Nutrition Education Program for Women, Infants and Children (WIC) and randomly assigned to either: (a) a peer-led weight loss intervention (n = 11) or (b) usual WIC care (n = 11). The intervention provided skills training and problem solving via six calls and two in-person visits with a Black mother trained in behavioral weight control strategies. Text messaging and Facebook served as platforms for self-monitoring, additional content, and interpersonal support. Both arms completed baseline and 14 week follow-up assessments. All participants were retained in the trial. Intervention engagement was high; the majority (55%) responded to at least 50% of the self-monitoring text prompts, and an average of 3.4 peer calls and 1.7 visits were completed. Mean weight loss among intervention participants was -1.4 ± 4.2 kg compared to a mean weight gain of 3.5 ± 6.0 kg in usual WIC care. Most intervention participants strongly agreed that the skills they learned were extremely useful (90%) and that the coach calls were extremely helpful for weight control (80%). Results suggest the feasibility of incorporating peer coaching into a postpartum weight loss intervention for ethnic minority women with obesity. Future research should examine the sustained impact in a larger trial.",2021,"Intervention engagement was high; the majority (55%) responded to at least 50% of the self-monitoring text prompts, and an average of 3.4 peer calls and 1.7 visits were completed.","['Twenty-two obese, Black or Latina mothers', 'ethnic minority women with obesity', 'Black and Latina mothers', '≤6 months postpartum were recruited from the']","['skills training and problem solving via six calls and two in-person visits with a Black mother trained in behavioral weight control strategies', 'peer coaching into a postpartum weight loss intervention', 'peer-led weight loss intervention (n = 11) or (b) usual WIC care', 'peer coach to deliver a behavioral intervention', 'peer coaching', 'Peer coaching', 'Philadelphia Special Supplemental Nutrition Education Program']","['postpartum weight loss', 'Mean weight loss']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",22.0,0.0613401,"Intervention engagement was high; the majority (55%) responded to at least 50% of the self-monitoring text prompts, and an average of 3.4 peer calls and 1.7 visits were completed.","[{'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Center for Obesity Research and Education, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Veronica M', 'Initials': 'VM', 'LastName': 'Bersani', 'Affiliation': 'Center for Obesity Research and Education, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Santoro', 'Affiliation': 'Center for Obesity Research and Education, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Saleemah J', 'Initials': 'SJ', 'LastName': 'McNeil', 'Affiliation': 'Oshun Family Center, Philadelphia, PA, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Kilby', 'Affiliation': 'Special Supplemental Nutrition Education Program for Women, Infants and Children, Philadelphia, PA, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Bailer', 'Affiliation': 'Center for Obesity Research and Education, Temple University, Philadelphia, PA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa096']
213,33184717,"The effect of sonic activation of irrigant on postoperative pain after root canal treatment in primary molar teeth: a randomized, clinical study.","PURPOSE


Postoperative pain following root canal treatment is a concern for pediatric patients and pediatric dentists. The purpose of this study was to evaluate the effect of using sonic activation (SA) on postoperative pain levels after root canal therapy of primary molars.
METHODS


A total of 110 patients aged 5-9 years with symptomatic irreversible pulpitis involving primary molars were included in the study and were randomly divided into two groups according to agitation methods: SA and no sonic activation (NSA). Root canal treatments were completed, and the teeth were restored permanently. Postoperative pain levels were evaluated using the five-face scale at 8, 24, 48, and 72 h and 1 week after treatment. Pain levels and frequency of analgesic intake were recorded and analyzed.
RESULTS


Postoperative pain values were lower in the SA group than in the NSA group at 8, 24, and 48 h after treatment (p < 0.05). No significant difference was observed between the groups in terms of postoperative pain values at 72 h and 1 week after treatment (p > 0.05).
CONCLUSIONS


It was determined that the use of SA reduces postoperative pain level significantly after root canal treatment in primary molar teeth.
CLINICAL RELEVANCE


The use of SA can be recommended to clinicians since it is effective in the successful management of postoperative pain of root canal treatment in primary molar teeth.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT04197531.",2021,"No significant difference was observed between the groups in terms of postoperative pain values at 72 h and 1 week after treatment (p > 0.05).
","['after root canal therapy of primary molars', 'primary molar teeth', 'pediatric patients and pediatric dentists', '110 patients aged 5-9 years with symptomatic irreversible pulpitis involving primary molars']","['agitation methods: SA and no sonic activation (NSA', 'NSA', 'sonic activation (SA', 'SA', 'root canal treatment']","['Pain levels and frequency of analgesic intake', 'Postoperative pain values', 'Postoperative pain levels', 'postoperative pain level', 'postoperative pain values', 'postoperative pain', 'postoperative pain levels']","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0227108', 'cui_str': 'Structure of deciduous molar tooth'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0586985', 'cui_str': 'Pedodontist'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",110.0,0.0577139,"No significant difference was observed between the groups in terms of postoperative pain values at 72 h and 1 week after treatment (p > 0.05).
","[{'ForeName': 'Hüsniye', 'Initials': 'H', 'LastName': 'Gümüş', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Delikan', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Nuh Naci Yazgan University, Kayseri, Turkey. e.delikan@gmail.com.'}]",Clinical oral investigations,['10.1007/s00784-020-03687-6']
214,33206270,Efficacy of Pregabalin and Antioxidants Combination in Reducing Pain in Chronic Pancreatitis: A Double Blind Randomized Trial.,"BACKGROUND


In patients with chronic pancreatitis (CP), pain relief is a dilemma. Antioxidants with pregabalin therapy have been reported to be useful. Hence, this study was carried out to determine the efficacy of the combination of antioxidant and pregabalin therapy in reducing pain in patients with CP.
METHODS


This was a prospective, double blind, superiority, and randomized trial in patients with CP. The treatment group received pregabalin with antioxidants therapy for 8 weeks, and a similar placebo was administered to the controls. Primary outcome was to determine the change in maximum pain intensity assessed by visual analog scale (VAS) and Izbicki pain score. Secondary outcomes were the number of painful days, opioid and non-opioid requirements, improvement in quality of life, number of hospital admission, and overall patient satisfaction.
RESULTS


A total of 90 patients were randomized to 45 in each arm. Demographic profile and baseline pain score were comparable. Patients in treatment group when compared to placebo group had a significant reduction in pain intensity (VAS score 2 ± 0.8 vs. 1.3 ± 0.9; p = 0.007), non-opioid analgesic requirement in days (54.4±2.9 vs. 55.7±1.5; p = 0.014), and number of hospital admissions (0.2 ± 0.5 vs. 0.6 ± 0.7; p = 0.002), respectively. Significant proportion of patients was satisfied in the treatment group compared to placebo group (18% vs. 11%; p = 0.03).
CONCLUSION


The combination of pregabalin and antioxidant significantly reduces the pain, requirement of non-opioid analgesics, and the number of hospital admissions in patients with CP. It also significantly improves the overall patient satisfaction.
CLINICAL TRIALS REGISTER NUMBER


CTRI/2017/05/008492.",2021,"Patients in treatment group when compared to placebo group had a significant reduction in pain intensity (VAS score 2 ± 0.8 vs. 1.3 ± 0.9; p = 0.007), non-opioid analgesic requirement in days (54.4±2.9 vs. 55.7±1.5; p = 0.014), and number of hospital admissions (0.2 ± 0.5 vs. 0.6 ± 0.7; p = 0.002), respectively.","['Chronic Pancreatitis', 'patients with chronic pancreatitis (CP', 'A total of 90 patients', 'patients with CP']","['antioxidant and pregabalin therapy', 'Pregabalin and Antioxidants Combination', 'Antioxidants with pregabalin therapy', 'placebo', 'pregabalin with antioxidants therapy', 'pregabalin and antioxidant']","['non-opioid analgesic requirement', 'number of hospital admissions', 'pain intensity', 'overall patient satisfaction', 'pain, requirement of non-opioid analgesics', 'Demographic\xa0profile and baseline pain score', 'change in maximum pain intensity assessed by visual analog scale (VAS) and Izbicki pain score', 'number of painful days, opioid and non-opioid requirements, improvement in quality of life, number of hospital admission, and overall patient satisfaction']","[{'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1879713', 'cui_str': 'Antioxidant therapy'}]","[{'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",90.0,0.555588,"Patients in treatment group when compared to placebo group had a significant reduction in pain intensity (VAS score 2 ± 0.8 vs. 1.3 ± 0.9; p = 0.007), non-opioid analgesic requirement in days (54.4±2.9 vs. 55.7±1.5; p = 0.014), and number of hospital admissions (0.2 ± 0.5 vs. 0.6 ± 0.7; p = 0.002), respectively.","[{'ForeName': 'Sathasivam', 'Initials': 'S', 'LastName': 'Sureshkumar', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Agrawal', 'Initials': 'A', 'LastName': 'Omang', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Amaranathan', 'Initials': 'A', 'LastName': 'Anandhi', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Rajesh', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Abdulbasith', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Chellappa', 'Initials': 'C', 'LastName': 'Vijayakumar', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Chinnakali', 'Initials': 'C', 'LastName': 'Palanivel', 'Affiliation': 'Department of PSM, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Pazhanivel', 'Affiliation': 'Department of Medical Gastroenterology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India. drvikramkate@gmail.com.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06711-7']
215,33164085,"Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial.","OBJECTIVE


To evaluate the feasibility of recruitment, preliminary efficacy, and acceptability of auricular percutaneous electrical nerve field stimulation (PENFS) for the treatment of fibromyalgia in veterans, using neuroimaging as an outcome measure and a biomarker of treatment response.
DESIGN


Randomized, controlled, single-blind.
SETTING


Government hospital.
SUBJECTS


Twenty-one veterans with fibromyalgia were randomized to standard therapy (ST) control or ST with auricular PENFS treatment.
METHODS


Participants received weekly visits with a pain practitioner over 4 weeks. The PENFS group received reapplication of PENFS at each weekly visit. Resting-state functional connectivity magnetic resonance imaging (rs-fcMRI) data were collected within 2 weeks prior to initiating treatment and 2 weeks following the final treatment. Analysis of rs-fcMRI used a right posterior insula seed. Pain and function were assessed at baseline and at 2, 6, and 12 weeks post-treatment.
RESULTS


At 12 weeks post-treatment, there was a nonsignificant trend toward improved pain scores and significant improvements in pain interference with sleep among the PENFS treatment group as compared with the ST controls. Neuroimaging data displayed increased connectivity to areas of the cerebellum and executive control networks in the PENFS group as compared with the ST control group following treatment.
CONCLUSIONS


There was a trend toward improved pain and function among veterans with fibromyalgia in the ST + PENFS group as compared with the ST control group. Pain and functional outcomes correlated with altered rs-fcMRI network connectivity. Neuroimaging results differed between groups, suggesting an alternative underlying mechanism for PENFS analgesia.",2021,There was a trend toward improved pain and function among veterans with fibromyalgia in the ST + PENFS group as compared with the ST control group.,"['Fibromyalgia', 'fibromyalgia in veterans', 'Government hospital', 'Twenty-one veterans with fibromyalgia', 'Participants received weekly visits with a pain practitioner over 4\xa0weeks']","['standard therapy (ST) control or ST with auricular PENFS treatment', 'PENFS', 'ST + PENFS', 'Auricular Field Stimulation', 'auricular percutaneous electrical nerve field stimulation (PENFS', 'reapplication of PENFS']","['pain and function', 'Pain and function', 'pain interference with sleep', 'Pain and functional outcomes', 'pain scores']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",21.0,0.0870428,There was a trend toward improved pain and function among veterans with fibromyalgia in the ST + PENFS group as compared with the ST control group.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Woodbury', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Venkatagiri', 'Initials': 'V', 'LastName': 'Krishnamurthy', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Melat', 'Initials': 'M', 'LastName': 'Gebre', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': 'Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Bicknese', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Mofei', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Emory University Rollins School of Public Health, Atlanta, Georgia, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Lukemire', 'Affiliation': 'Emory University Rollins School of Public Health, Atlanta, Georgia, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Kalangara', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Xiangqin', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Atlanta Veterans Affairs Health Care System, Atlanta, Georgia, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Emory University Rollins School of Public Health, Atlanta, Georgia, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Sniecinski', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Crosson', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa317']
216,33165612,Effects of Reduced-Nicotine Cigarettes Across Regulatory Environments in the Experimental Tobacco Marketplace: A Randomized Trial.,"INTRODUCTION


Cigarette smoking remains the leading preventable cause of death in the United States. Recent efforts have explored the potential health and policy benefits of reducing nicotine, an addictive component, in combustible cigarettes. To date, an experimental, prospective analysis directly comparing the effects of varying regulatory environments on purchases of multiple products has yet to be conducted. The present study compared real purchasing of conventional cigarettes, reduced-nicotine cigarettes, and a variety of other nicotine and tobacco products across a range of regulatory environments.
METHODS


Participants were assigned to one of five groups, each associated with a different nicotine level (mg of nicotine to g of tobacco) in SPECTRUM investigational cigarettes (15.8, 5.2, 2.4, 1.3, and 0.4 mg/g). Across sessions, participants made real purchases for nicotine/tobacco products in an Experimental Tobacco Marketplace. Each session corresponded with a distinct regulatory environment wherein different nicotine/tobacco products were available for purchase.
RESULTS


Our results suggest that the primary drivers of cigarette and nicotine purchasing are regulatory environment and the presence/absence of alternative nicotine and tobacco products. Perhaps surprisingly, nicotine level does not appear to be such a driver of purchasing behavior under these experimental conditions. Investigational cigarette purchasing is lowest when other preferred combustible products are available and highest when investigational cigarettes are the only combustible product available for purchase.
CONCLUSIONS


If a reduced-nicotine policy is implemented, great care should be taken in determining and making available less-harmful nicotine/tobacco products as the availability of preferred combustible products may result in undesirable levels of purchasing.
IMPLICATIONS


This is the first experimental study investigating different potential regulatory effects related to a reduced-nicotine policy by examining purchasing across a range of nicotine/tobacco products. Our results suggest the presence of affordable, highly preferred combustible products is likely to maintain tobacco purchasing at undesirable levels. To promote switching to less-harmful products, affordable alternate nicotine and tobacco products should be readily available. Finally, our results suggest that the availability of noncigarette products, not cigarette nicotine level, will most likely affect purchasing of reduced-nicotine cigarettes.",2021,"Perhaps surprisingly, nicotine level does not appear to be such a driver of purchasing behavior under these experimental conditions.","['Participants', 'Experimental Tobacco Marketplace']","['nicotine level (mg of nicotine to g of tobacco', 'real purchasing of conventional cigarettes, reduced-nicotine cigarettes', 'Reduced-Nicotine Cigarettes']",[],"[{'cui': 'C0040329', 'cui_str': 'Tobacco'}]","[{'cui': 'C0202431', 'cui_str': 'Nicotine measurement'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",[],,0.027091,"Perhaps surprisingly, nicotine level does not appear to be such a driver of purchasing behavior under these experimental conditions.","[{'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Kaplan', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, KY.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Koffarnus', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, KY.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Franck', 'Affiliation': 'Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Addiction Recovery Research Center, Fralin Biomedical Research Institute at VTC, Roanoke, VA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa226']
217,33174614,Changes in Identification of Possible Pain Coping Strategies by People with Osteoarthritis who Complete Web-based Pain Coping Skills Training.,"BACKGROUND


We previously demonstrated that automated, Web-based pain coping skills training (PCST) can reduce osteoarthritis pain. The present secondary analyses examined whether this program also changed coping strategies participants identified for use in hypothetical pain-related situations.
METHOD


People with hip/knee osteoarthritis (n = 107) were randomized to Web-based PCST or standard care control. At baseline and post-intervention, they reported their pain severity and impairment, then completed a task in which they described how they would cope with pain in four hypothetical pain-related situations, also reporting their perceived risk for pain and self-efficacy for managing it. We coded the generated coping strategies into counts of adaptive behavioral, maladaptive behavioral, adaptive cognitive, and discrete adaptive coping strategies (coping repertoire).
RESULTS


Compared to the control arm, Web-based PCST decreased the number of maladaptive behavioral strategies generated (p = 0.002) while increasing the number of adaptive behavioral strategies generated (p = 0.006), likelihood of generating at least one adaptive cognitive strategy (p = 0.01), and the size of participants' coping repertoire (p = 0.009). Several of these changes were associated with changes in pain outcomes (ps = 0.01 to 0.65). Web-based PCST also reduced perceived risk for pain in the situations (p = 0.03) and increased self-efficacy for avoiding pain in similar situations (p < 0.001).
CONCLUSION


Salutary changes found in this study appear to reflect intervention-concordant learning.",2021,"Web-based PCST also reduced perceived risk for pain in the situations (p = 0.03) and increased self-efficacy for avoiding pain in similar situations (p < 0.001).
","['People with Osteoarthritis who Complete Web-based Pain Coping Skills Training', 'People with hip/knee osteoarthritis (n\xa0=\xa0107']","['PCST or standard care control', 'Web-based pain coping skills training (PCST']","['number of adaptive behavioral strategies', 'osteoarthritis pain', 'likelihood of generating at least one adaptive cognitive strategy', 'number of maladaptive behavioral strategies', 'self-efficacy for avoiding pain', 'risk for pain', ""size of participants' coping repertoire"", 'pain outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",107.0,0.0537673,"Web-based PCST also reduced perceived risk for pain in the situations (p = 0.03) and increased self-efficacy for avoiding pain in similar situations (p < 0.001).
","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rini', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA. christine.rini@northwestern.edu.'}, {'ForeName': 'Ariana W K', 'Initials': 'AWK', 'LastName': 'Katz', 'Affiliation': 'RTI International, Berkeley, CA, USA.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Nwadugbo', 'Affiliation': 'U.S. Government Accountability Office, Washington, DC, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09938-w']
218,33184629,"Vitamin E catabolism in women, as modulated by food and by fat, studied using 2 deuterium-labeled α-tocopherols in a 3-phase, nonrandomized crossover study.","BACKGROUND


Human vitamin E (α-tocopherol) catabolism is a mechanism for regulating whole-body α-tocopherol.
OBJECTIVES


To determine the roles of the intestine and liver on α-tocopherol catabolism as affected by fat or fasting, 2 deuterium-labeled (intravenous d6- and oral d3-) forms of α-tocopherol were used.
METHODS


Healthy women received intravenous d6-α-tocopherol and consumed d3-α-tocopherol with a 600-kcal defined liquid meal (DLM; 40% or 0% fat, n = 10) followed by controlled meals; or the 0% fat DLM (n = 7) followed by a 12-h fast (0% fat-fast), then controlled meals ≤72 h. The order of the 3-phase crossover design was not randomized and there was no blinding. Samples were analyzed by LC/MS to determine the α-tocopherol catabolites and α-carboxyethyl hydroxychromanol (α-CEHC) in urine, feces, and plasma that were catabolized from administered oral d3- and intravenous d6-α-tocopherols.
RESULTS


Urinary and plasma d3- and d6-α-CEHC concentrations varied differently with the interventions. Mean ± SEM cumulative urinary d6-α-CEHC derived from the intravenous dose excreted over 72 h during the 40% fat (2.50 ± 0.37 μmol/g creatinine) and 0% fat (2.37 ± 0.37 μmol/g creatinine) interventions were similar, but a ∼50% decrease was observed during the 0% fat-fast (1.05 ± 0.39 μmol/g creatinine) intervention (compared with 0% fat, P = 0.0005). Cumulative urinary d3-α-CEHC excretion was not significantly changed by any intervention. Total urinary and fecal excretion of catabolites accounted for <5% of each of the administered doses.
CONCLUSIONS


Differential catabolism of the intravenous d6-α-tocopherol and oral d3-α-tocopherol doses shows both liver and intestine have roles in α-tocopherol catabolism. During the 40% fat intervention, >90% of urinary d3-α-CEHC excretion was estimated to be liver-derived, whereas during fasting <50% was from the liver with the remainder from the intestine, suggesting that there was increased intestinal α-tocopherol catabolism while d3-α-tocopherol was retained in the intestine in the absence of adequate fat/food for α-tocopherol absorption.This trial was registered at clinicaltrials.gov as NCT00862433.",2020,Cumulative urinary d3-α-CEHC excretion was not significantly changed by any intervention.,['Healthy women received'],"['intravenous d6-α-tocopherol and consumed d3-α-tocopherol with a 600-kcal defined liquid meal (DLM; 40% or 0% fat, n\xa0=\xa010) followed by controlled meals; or the 0% fat DLM', 'Vitamin E catabolism', 'd6-α-tocopherol and oral d3-α-tocopherol']","['Total urinary and fecal excretion of catabolites', 'urinary d3-α-CEHC excretion', 'Mean\xa0±', 'SEM cumulative urinary d6-α-CEHC', 'intestinal α-tocopherol catabolism', 'Urinary and plasma d3- and d6-α-CEHC concentrations', 'Cumulative urinary d3-α-CEHC excretion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0543484', 'cui_str': 'catabolism'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0543484', 'cui_str': 'catabolism'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0328709,Cumulative urinary d3-α-CEHC excretion was not significantly changed by any intervention.,"[{'ForeName': 'Maret G', 'Initials': 'MG', 'LastName': 'Traber', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Leonard', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Ifechukwude', 'Initials': 'I', 'LastName': 'Ebenuwa', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Pierre-Christian', 'Initials': 'PC', 'LastName': 'Violet', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Niyyati', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Padayatty', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Bobe', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Levine', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa298']
219,33184632,The impact of diets rich in low-fat or full-fat dairy on glucose tolerance and its determinants: a randomized controlled trial.,"BACKGROUND


Dairy foods, particularly yogurt, and plasma biomarkers of dairy fat intake are consistently inversely associated with incident type 2 diabetes. Yet, few trials assessing the impact of dairy on glucose homeostasis include fermented or full-fat dairy foods.
OBJECTIVES


We aimed to compare the effects of diets rich in low-fat or full-fat milk, yogurt, and cheese on glucose tolerance and its determinants, with those of a limited dairy diet.
METHODS


In this parallel-design randomized controlled trial, 72 participants with metabolic syndrome completed a 4-wk wash-in period, limiting dairy intake to ≤3 servings/wk of nonfat milk. Participants were then randomly assigned to either continue the limited dairy diet, or switch to a diet containing 3.3 servings/d of either low-fat or full-fat dairy for 12 wk. Outcome measures included glucose tolerance (area under the curve glucose during an oral-glucose-tolerance test), insulin sensitivity, pancreatic β-cell function, systemic inflammation, liver-fat content, and body weight and composition.
RESULTS


In the per-protocol analysis (n = 67), we observed no intervention effect on glucose tolerance (P = 0.340). Both the low-fat and full-fat dairy diets decreased the Matsuda insulin sensitivity index (ISI) (means ± SDs -0.47 ± 1.07 and -0.25 ± 0.91, respectively) and as compared with the limited dairy group (0.00 ± 0.92) (P = 0.012 overall). Body weight also changed differentially (P = 0.006 overall), increasing on full-fat dairy (+1.0 kg; -0.2, 1.8 kg) compared with the limited dairy diet (-0.4 kg; -2.5, 0.7 kg), whereas the low-fat dairy diet (+0.3 kg; -1.1, 1.9 kg) was not significantly different from the other interventions. Intervention effects on the Matsuda ISI remained after adjusting for changes in adiposity. No intervention effects were detected for liver fat content or systemic inflammation. Findings in intent-to-treat analyses (n = 72) were consistent.
CONCLUSIONS


Contrary to our hypothesis, neither dairy diet improved glucose tolerance in individuals with metabolic syndrome. Both dairy diets decreased insulin sensitivity through mechanisms largely unrelated to changes in key determinants of insulin sensitivity.This trial was registered at clinicaltrials.gov as NCT02663544.",2021,"Body weight also changed differentially (P = 0.006 overall), increasing on full-fat dairy (+1.0 kg; -0.2, 1.8 kg) compared with the limited dairy diet (-0.4 kg; -2.5, 0.7 kg), whereas the low-fat dairy diet (+0.3 kg; -1.1, 1.9 kg) was not significantly different from the other interventions.","['72 participants with metabolic syndrome completed a 4-wk wash-in period, limiting dairy intake to ≤3 servings/wk of nonfat milk', 'individuals with metabolic syndrome']","['continue the limited dairy diet, or switch to a diet containing 3.3 servings/d of either low-fat or full-fat dairy for 12 wk', 'dairy diet']","['full-fat dairy', 'glucose tolerance (area under the curve glucose during an oral-glucose-tolerance test), insulin sensitivity, pancreatic β-cell function, systemic inflammation, liver-fat content, and body weight and composition', 'glucose tolerance', 'liver fat content or systemic inflammation', 'Matsuda ISI', 'Matsuda insulin sensitivity index (ISI', 'Body weight', 'insulin sensitivity']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1547959', 'cui_str': 'Wash'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",72.0,0.0863317,"Body weight also changed differentially (P = 0.006 overall), increasing on full-fat dairy (+1.0 kg; -0.2, 1.8 kg) compared with the limited dairy diet (-0.4 kg; -2.5, 0.7 kg), whereas the low-fat dairy diet (+0.3 kg; -1.1, 1.9 kg) was not significantly different from the other interventions.","[{'ForeName': 'Kelsey A', 'Initials': 'KA', 'LastName': 'Schmidt', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Cromer', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Maggie S', 'Initials': 'MS', 'LastName': 'Burhans', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jessica N', 'Initials': 'JN', 'LastName': 'Kuzma', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Derek K', 'Initials': 'DK', 'LastName': 'Hagman', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Imashi', 'Initials': 'I', 'LastName': 'Fernando', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Merideth', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'VA Puget Sound Health Care System, Seattle, WA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Holte', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kraft', 'Affiliation': 'The College of Agriculture and Life Sciences, The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Kratz', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa301']
220,33206192,Effect of Vitamin D3 Supplements on Development of Advanced Cancer: A Secondary Analysis of the VITAL Randomized Clinical Trial.,"Importance


Epidemiologic and trial data suggest that vitamin D supplementation may reduce metastatic cancer and cancer mortality, reflecting shared biological pathways.
Objective


To follow up on the possible reduction in cancer death in the Vitamin D and Omega-3 Trial (VITAL) with an evaluation of whether vitamin D reduces the incidence of advanced (metastatic or fatal) cancer and an examination possible effect modification by body mass index.
Design, Setting, and Participants


VITAL is a randomized, double-blind, placebo-controlled, 2 × 2 factorial clinical trial of vitamin D3 (cholecalciferol, 2000 IU/d) and marine omega-3 fatty acids (1 g/d). This multicenter clinical trial was conducted in the United States; participants included men aged 50 years or older and women aged 55 years or older who were free of cancer and cardiovascular disease at baseline. Randomization took place from November 2011 through March 2014, and study medication ended on December 31, 2017. Data for this secondary analysis were analyzed from November 1, 2011, to December 31, 2017.
Interventions


Vitamin D3 (cholecalciferol, 2000 IU/d) and marine omega-3 fatty acids (1 g/d) supplements.
Main Outcomes and Measures


For the present analysis, the primary outcome was a composite incidence of metastatic and fatal invasive total cancer, because the main VITAL study showed a possible reduction in fatal cancer with vitamin D supplementation and effect modification by body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) for total cancer incidence reduction for individuals with normal BMI, but not for individuals with overweight or obesity. Secondary analyses included examination of BMI (<25, 25 to < 30, and ≥30) as effect modifiers of the observed associations.
Results


Among 25 871 randomized VITAL participants (51% female; mean [SD] age, 67.1 [7.1] years), 1617 were diagnosed with invasive cancer over a median intervention period of 5.3 years (range, 3.8-6.1 years). As previously reported, no significant differences for cancer incidence by treatment arm were observed. However, a significant reduction in advanced cancers (metastatic or fatal) was found for those randomized to vitamin D compared with placebo (226 of 12 927 assigned to vitamin D [1.7%] and 274 of 12 944 assigned to placebo [2.1%]; HR, 0.83 [95% CI, 0.69-0.99]; P = .04). When stratified by BMI, there was a significant reduction for the vitamin D arm in incident metastatic or fatal cancer among those with normal BMI (BMI<25: HR, 0.62 [95% CI, 0.45-0.86]) but not among those with overweight or obesity (BMI 25-<30: HR, 0.89 [95% CI, 0.68-1.17]; BMI≥30: HR, 1.05 [95% CI, 0.74-1.49]) (P = .03 for interaction by BMI).
Conclusions and Relevance


In this randomized clinical trial, supplementation with vitamin D reduced the incidence of advanced (metastatic or fatal) cancer in the overall cohort, with the strongest risk reduction seen in individuals with normal weight.
Trial Registration


ClinicalTrials.gov Identifier: NCT01169259.",2020,"However, a significant reduction in advanced cancers (metastatic or fatal) was found for those randomized to vitamin D compared with placebo (226 of 12 927 assigned to vitamin D [1.7%] and 274 of 12 944 assigned to placebo [2.1%]; HR, 0.83","['Among 25\u202f871 randomized VITAL participants (51% female; mean [SD] age, 67.1 [7.1] years), 1617 were diagnosed with invasive cancer over a median intervention period of 5.3 years (range, 3.8-6.1 years', 'United States; participants included men aged 50 years or older and women aged 55 years or older who were free of cancer and cardiovascular disease at baseline', 'individuals with normal weight', 'Advanced Cancer']","['vitamin D supplementation', 'vitamin D', 'vitamin D3 (cholecalciferol, 2000 IU/d) and marine omega-3 fatty acids', 'placebo', 'Vitamin D3 Supplements', 'Vitamin D3 (cholecalciferol, 2000 IU/d) and marine omega-3 fatty acids']","['cancer incidence', 'fatal cancer with vitamin D supplementation and effect modification by body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) for total cancer incidence reduction', 'examination of BMI', 'advanced cancers (metastatic or fatal', 'metastatic cancer and cancer mortality', 'incidence of advanced (metastatic or fatal) cancer', 'composite incidence of metastatic and fatal invasive total cancer']","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]",25871.0,0.654187,"However, a significant reduction in advanced cancers (metastatic or fatal) was found for those randomized to vitamin D compared with placebo (226 of 12 927 assigned to vitamin D [1.7%] and 274 of 12 944 assigned to placebo [2.1%]; HR, 0.83","[{'ForeName': 'Paulette D', 'Initials': 'PD', 'LastName': 'Chandler', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Wendy Y', 'Initials': 'WY', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Oluremi N', 'Initials': 'ON', 'LastName': 'Ajala', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Hazra', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Willett', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.25850']
221,33212205,Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.,"RATIONALE & OBJECTIVE


Although maintaining high fluid intake is an effective low-risk intervention for the secondary prevention of urinary stone disease, many patients with stones do not increase their fluid intake.
STUDY DESIGN


We describe the rationale and design of the Prevention of Urinary Stones With Hydration (PUSH) Study, a randomized trial of a multicomponent behavioral intervention program to increase and maintain high fluid intake. Participants are randomly assigned (1:1 ratio) to the intervention or control arm. The target sample size is 1,642 participants.
SETTING & PARTICIPANTS


Adults and adolescents 12 years and older with a symptomatic stone history and low urine volume are eligible. Exclusion criteria include infectious or monogenic causes of urinary stone disease and comorbid conditions precluding increased fluid intake.
INTERVENTIONS


All participants receive usual care and a smart water bottle with smartphone application. Participants in the intervention arm receive a fluid intake prescription and an adaptive program of behavioral interventions, including financial incentives, structured problem solving, and other automated adherence interventions. Control arm participants receive guideline-based fluid instructions.
OUTCOMES


The primary end point is recurrence of a symptomatic stone during 24 months of follow-up. Secondary end points include changes in radiographic stone burden, 24-hour urine output, and urinary symptoms.
LIMITATIONS


Periodic 24-hour urine volumes may not fully reflect daily behavior.
CONCLUSIONS


With its highly novel features, the PUSH Study will address an important health care problem.
FUNDING


National Institute of Diabetes and Digestive and Kidney Diseases.
TRIAL REGISTRATION


Registered at ClinicalTrials.gov with study number NCT03244189.",2021,"Secondary endpoints include changes in radiographic stone burden, 24-hour urine output, and urinary symptoms.
","['Adults and adolescents ≥12 years of age with a symptomatic stone history and low urine volume are eligible', '1642 participants']","['usual care and a smart water bottle and smartphone application', 'multi-component behavioral intervention program', 'guideline-based fluid instructions', 'fluid intake prescription and an adaptive program of behavioral interventions, including financial incentives, structured problem solving, and other automated adherence interventions', 'Urinary Stones with Hydration (PUSH', 'Urinary Stones With Hydration (PUSH']","['recurrence of a symptomatic stone over 24-months of follow-up', 'changes in radiographic stone burden, 24-hour urine output, and urinary symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042018', 'cui_str': 'Urolith'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0429776', 'cui_str': '24 hour urine output'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}]",,0.147676,"Secondary endpoints include changes in radiographic stone burden, 24-hour urine output, and urinary symptoms.
","[{'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Scales', 'Affiliation': 'Urologic Surgery and Population Health Science, Duke Surgical Center for Outcomes Research, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address: chuck.scales@duke.edu.'}, {'ForeName': 'Alana C', 'Initials': 'AC', 'LastName': 'Desai', 'Affiliation': 'Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Harper', 'Affiliation': 'Department of Urology, University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'H Henry', 'Initials': 'HH', 'LastName': 'Lai', 'Affiliation': 'Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Naim M', 'Initials': 'NM', 'LastName': 'Maalouf', 'Affiliation': 'Department of Internal Medicine and Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Reese', 'Affiliation': 'Renal-Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Tasian', 'Affiliation': ""Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Division of Pediatric Urology, Department of Surgery, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Kirkali', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Wessells', 'Affiliation': 'Department of Urology, University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.09.016']
222,33163463,Randomized Control Trial of Postnatal rhIGF-1/rhIGFBP-3 Replacement in Preterm Infants:  Post-hoc  Analysis of Its Effect on Brain Injury.,"Background:  Postnatal insulin-like growth factor-1 (IGF-1) replacement with recombinant human (rh)IGF-1 and IGF binding protein-3 (rhIGF-1/rhIGFBP-3) is being studied as a potential treatment to reduce comorbidities of prematurity. We have recently reported on a phase II, multicenter, randomized, controlled trial comparing postnatal rhIGF-1/rhIGFBP-3 replacement with standard of care (SOC) in extremely preterm infants (NCT01096784). Maximum severity of retinopathy of prematurity was the primary endpoint of the trial and presence of GMH-IVH/PHI one of the pre-specified secondary endpoints. Infants therefore received serial cranial ultrasound scans (CUS) between birth and term age. In this  post-hoc  analysis we present a detailed analysis of the CUS data of this trial and evaluate the effect of postnatal rhIGF-1/rhIGFBP-3 replacement on the incidence of different kinds of brain injury in extremely preterm infants.  Methods:  This report is an exploratory  post-hoc  analysis of a phase II trial in which infants <28 weeks gestational age were randomly allocated to rhIGF-1/rhIGFBP-3 or SOC. Serial cranial ultrasounds were performed between birth and term-equivalent age. Presence of germinal matrix hemorrhage and intraventricular hemorrhage (GMH-IVH), periventricular hemorrhagic infarction (PHI), post-hemorrhagic ventricular dilatation, and white matter injury (WMI) were scored by two independent masked readers.  Results:  The analysis included 117 infants; 58 received rhIGF-1/rhIGFBP-3 and 59 received SOC. A trend toward less grade II-III GMH-IVH and PHI was observed in treated infants vs. SOC. A subanalysis of infants without evidence of GMH-IVH at study entry ( n  = 104) showed reduced progression to GMH-IVH in treated infants (25.0% [13/52] vs. 40.4% [21/52]; not significant). No effects of rhIGF-1/rhIGFBP-3 on WMI were observed.  Conclusion:  The potential protective effect of rhIGF-1/rhIGFBP-3 on the occurrence of GMH-IVH/PHI appeared most pronounced in infants with no evidence of GMH-IVH at treatment start.",2020,A trend toward less grade II-III GMH-IVH and PHI was observed in treated infants vs. SOC.,"['extremely preterm infants', 'infants with no evidence of GMH-IVH at treatment start', '117 infants; 58 received', 'infants <28 weeks gestational age', 'Preterm Infants']","['rhIGF-1/rhIGFBP-3 and 59 received SOC', 'serial cranial ultrasound scans (CUS', ':  Postnatal insulin-like growth factor-1 (IGF-1) replacement with recombinant human (rh)IGF-1 and IGF binding protein-3 (rhIGF-1/rhIGFBP-3', 'postnatal rhIGF-1/rhIGFBP-3 replacement with standard of care (SOC', 'rhIGF-1/rhIGFBP-3', 'Postnatal rhIGF-1/rhIGFBP-3 Replacement', 'rhIGF-1/rhIGFBP-3 or SOC', 'postnatal rhIGF-1/rhIGFBP-3 replacement']","['germinal matrix hemorrhage and intraventricular hemorrhage (GMH-IVH), periventricular hemorrhagic infarction (PHI), post-hemorrhagic ventricular dilatation, and white matter injury (WMI', 'progression to GMH-IVH', 'Maximum severity of retinopathy of prematurity', 'grade II-III GMH-IVH and PHI']","[{'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0013526', 'cui_str': 'Echoencephalography'}, {'cui': 'C0056599', 'cui_str': 'cupric sulfide'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0475737', 'cui_str': 'Perinatal subependymal hemorrhage'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0333549', 'cui_str': 'Hemorrhagic infarct'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0264733', 'cui_str': 'Cardiac ventricular dilatation'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1706536', 'cui_str': 'Phi'}]",117.0,0.226903,A trend toward less grade II-III GMH-IVH and PHI was observed in treated infants vs. SOC.,"[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Horsch', 'Affiliation': 'HELIOS Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Parodi', 'Affiliation': 'Neonatal Intensive Care Unit, Department Mother and Child, IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': 'Boubou', 'Initials': 'B', 'LastName': 'Hallberg', 'Affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mariya', 'Initials': 'M', 'LastName': 'Malova', 'Affiliation': 'Neonatal Intensive Care Unit, Department Mother and Child, IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': 'Isabella M', 'Initials': 'IM', 'LastName': 'Björkman-Burtscher', 'Affiliation': 'Department of Clinical Sciences Lund, Radiology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Hansen-Pupp', 'Affiliation': 'Department of Clinical Sciences Lund, Pediatrics, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Marlow', 'Affiliation': ""Department of Academic Neonatology, UCL Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, United Kingdom.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Beardsall', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'van Weissenbruch', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Vrije Universiteit University Medical Center, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Lois E H', 'Initials': 'LEH', 'LastName': 'Smith', 'Affiliation': ""Harvard Medical School, Boston Children's Hospital, Boston, MA, United States.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamdani', 'Affiliation': 'Global Clinical Development, Rare Metabolic Diseases, Shire, a Takeda Company, Lexington, MA, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Mangili', 'Affiliation': 'Global Clinical Development, Rare Metabolic Diseases, Shire, a Takeda Company, Zurich, Switzerland.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Barton', 'Affiliation': 'Global Clinical Development, Rare Metabolic Diseases, Shire, a Takeda Company, Lexington, MA, United States.'}, {'ForeName': 'Luca A', 'Initials': 'LA', 'LastName': 'Ramenghi', 'Affiliation': 'Neonatal Intensive Care Unit, Department Mother and Child, IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hellström', 'Affiliation': 'Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ley', 'Affiliation': 'Department of Clinical Sciences Lund, Pediatrics, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in pediatrics,['10.3389/fped.2020.517207']
223,33165539,Cannula With Long and Narrow Tubing vs Short Binasal Prongs for Noninvasive Ventilation in Preterm Infants: Noninferiority Randomized Clinical Trial.,"Importance


Use of cannulas with long and narrow tubing (CLNT) has gained increasing popularity for applying noninvasive respiratory support for newborn infants thanks to ease of use, perceived patient comfort, and reduced nasal trauma. However, there is concern that this interface delivers reduced and suboptimal support.
Objective


To determine whether CLNT is noninferior to short binasal prongs and masks (SPM) when providing nasal intermittent positive pressure ventilation (NIPPV) in preterm infants.
Design, Setting, and Participants


This randomized controlled, unblinded, prospective noninferiority trial was conducted between December 2017 and December 2019 at 2 tertiary neonatal intensive care units. Preterm infants born between 24 weeks' and 33 weeks and 6 days' gestation were eligible if presented with respiratory distress syndrome with the need for noninvasive ventilatory support either as initial treatment after birth or after first extubation. Analysis was performed by intention to treat.
Interventions


Randomization to NIPPV with either CLNT or SPM interface.
Main Outcomes and Measures


The primary outcome was the need for intubation within 72 hours after NIPPV treatment began. Noninferiority margin was defined as 15% or less absolute difference.
Results


Overall, 166 infants were included in this analysis, and infant characteristics and clinical condition (including fraction of inspired oxygen, Pco2, and pH level) were comparable at recruitment in the CLNT group (n = 83) and SPM group (n = 83). The mean (SD) gestational age was 29.3 (2.2) weeks vs 29.2 (2.5) weeks, and the mean (SD) birth weight was 1237 (414) g vs 1254 (448) g in the CLNT and SPM groups, respectively. Intubation within 72 hours occurred in 12 of 83 infants (14%) in the CLNT group and in 15 of 83 infants (18%) in the SPM group (risk difference, -3.6%; 95% CI, -14.8 to 7.6 [within the noninferiority margin], χ2 P = .53). Moderate to severe nasal trauma was significantly less common in the CLNT group compared with the SPM group (4 [5%] vs 14 [17%]; P = .01). There were no differences in other adverse events or in the course during hospitalization.
Conclusions and Relevance


In this study, CLNT was noninferior to SPM in providing NIPPV for preterm infants, while causing significantly less nasal trauma.
Trial Registration


ClinicalTrials.gov Identifier: NCT03081611.",2021,Moderate to severe nasal trauma was significantly less common in the CLNT group compared with the SPM group (4 [5%] vs 14 [17%];,"['preterm infants', 'newborn infants thanks', 'The mean (SD) gestational age was 29.3 (2.2) weeks vs 29.2 (2.5) weeks, and the mean (SD) birth weight was 1237 (414', ""Preterm infants born between 24 weeks' and 33 weeks and 6 days' gestation were eligible if presented with respiratory distress syndrome with the need for noninvasive ventilatory support either as initial treatment after birth or after first extubation"", 'December 2017 and December 2019 at 2 tertiary neonatal intensive care units', 'g vs 1254 (448', '166 infants', 'Preterm Infants']","['SPM', 'cannulas with long and narrow tubing (CLNT', 'nasal intermittent positive pressure ventilation (NIPPV', 'Cannula With Long and Narrow Tubing vs Short Binasal Prongs for Noninvasive Ventilation', 'CLNT']","['Moderate to severe nasal trauma', 'infant characteristics and clinical condition (including fraction of inspired oxygen, Pco2, and pH level', 'nasal trauma', 'adverse events', 'need for intubation', 'Intubation']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0201931', 'cui_str': 'Carbon dioxide measurement, partial pressure'}, {'cui': 'C1304686', 'cui_str': 'pH - finding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",166.0,0.345412,Moderate to severe nasal trauma was significantly less common in the CLNT group compared with the SPM group (4 [5%] vs 14 [17%];,"[{'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Hochwald', 'Affiliation': 'Rambam Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'Arieh', 'Initials': 'A', 'LastName': 'Riskin', 'Affiliation': 'Bnai Zion Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'Liron', 'Initials': 'L', 'LastName': 'Borenstein-Levin', 'Affiliation': 'Rambam Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Shoris', 'Affiliation': 'Bnai Zion Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'Gil P', 'Initials': 'GP', 'LastName': 'Dinur', 'Affiliation': 'Rambam Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Said', 'Affiliation': 'Bnai Zion Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'Huda', 'Initials': 'H', 'LastName': 'Jubran', 'Affiliation': 'Rambam Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Littner', 'Affiliation': 'Rambam Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Haddad', 'Affiliation': 'Rambam Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Mor', 'Affiliation': 'Rambam Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Timstut', 'Affiliation': 'Rambam Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bader', 'Affiliation': 'Bnai Zion Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Kugelman', 'Affiliation': 'Rambam Medical Center & Rapport Faculty of Medicine, Haifa, Israel.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.3579']
224,33165566,Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011.,"BACKGROUND


We report results of years 2 and 3 of consecutive cluster-randomized controlled trials of trivalent inactivated influenza vaccine (IIV3) in Senegal.
METHODS


We cluster-randomized (1:1) 20 villages to annual vaccination with IIV3 or inactivated poliovirus vaccine (IPV) of age-eligible residents (6 months-10 years). The primary outcome was total vaccine effectiveness against laboratory-confirmed influenza illness (LCI) among age-eligible children (modified intention-to-treat population [mITT]). Secondary outcomes were indirect (herd protection) and population (overall community) vaccine effectiveness.
RESULTS


We vaccinated 74% of 12 408 age-eligible children in year 2 (June 2010-April 11) and 74% of 11 988 age-eligible children in year 3 (April 2011-December 2011) with study vaccines. Annual cumulative incidence of LCI was 4.7 (year 2) and 4.2 (year 3) per 100 mITT child vaccinees of IPV villages. In year 2, IIV3 matched circulating influenza strains. The total effectiveness was 52.8% (95% confidence interval [CI], 32.3-67.0), and the population effectiveness was 36.0% (95% CI, 10.2-54.4) against LCI caused by any influenza strain. The indirect effectiveness against LCI by A/H3N2 was 56.4% (95% CI, 39.0-68.9). In year 3, 74% of influenza detections were vaccine-mismatched to circulating B/Yamagata and 24% were vaccine-matched to circulating A/H3N2. The year 3 total effectiveness against LCI was -14.5% (95% CI, -81.2-27.6). Vaccine effectiveness varied by type/subtype of influenza in both years.
CONCLUSIONS


IIV3 was variably effective against influenza illness in Senegalese children, with total and indirect vaccine effectiveness present during the year when all circulating strains matched the IIV3 formulation.
CLINICAL TRIALS REGISTRATION


NCT00893906.",2021,"IIV3 was variably effective against influenza illness in Senegalese children, with total and indirect vaccine effectiveness present during the year when all circulating strains matched the IIV3 formulation.","['12,408 age-eligible children in Year 2 (June 2010-April 11) and 74% of 11,988 age-eligible children in Year 3 (April 2011-December 2011) with study vaccines', 'of age-eligible residents (6 months - 10 years', 'children in Senegal']","['trivalent inactivated influenza vaccine (IIV3', 'annual vaccination with IIV3 or inactivated poliovirus vaccine (IPV']","['modified-intention-to-treat population [mITT', 'Annual cumulative incidence of LCI', 'indirect (herd protection) and population (overall community) vaccine effectiveness', 'total effectiveness', 'population effectiveness', 'total vaccine effectiveness against laboratory-confirmed influenza illness (LCI', 'Vaccine effectiveness']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",,0.255067,"IIV3 was variably effective against influenza illness in Senegalese children, with total and indirect vaccine effectiveness present during the year when all circulating strains matched the IIV3 formulation.","[{'ForeName': 'Mbayame Nd', 'Initials': 'MN', 'LastName': 'Niang', 'Affiliation': 'Institut Pasteur de Dakar, Dakar, Senegal.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Sugimoto', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Aldiouma', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Bou', 'Initials': 'B', 'LastName': 'Diarra', 'Affiliation': 'VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Kristen D C', 'Initials': 'KDC', 'LastName': 'Lewis', 'Affiliation': 'PATH, Seattle, Washington, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lafond', 'Affiliation': 'Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'M Elizabeth', 'Initials': 'ME', 'LastName': 'Halloran', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Marc-Alain', 'Initials': 'MA', 'LastName': 'Widdowson', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'PATH, Seattle, Washington, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1689']
225,33176960,Locking versus nonlocking superior plate fixations for displaced midshaft clavicle fractures: A prospective randomized trial comparing clinical and radiografic results.,"BACKGROUND


It is unknown whether locking or nonlocking superior plate fixation is better for managing displaced midshaft clavicle fractures. Therefore, we aimed to compare the clinical and radiographic outcomes of locking and nonlocking superior plate fixation of displaced midshaft clavicle fractures.
METHODS


A total of 102 consecutive patients with displaced midshaft clavicle fractures (2B1 and 2B2 in Robinson classification) participated in this randomized controlled trial; 12 patients were excluded. Surgeries were performed using a 3.5-mm Locking Compression Plate (LCP) between 2007 and 2015. Patients were treated either with a locking plate (group L, n = 45) or a nonlocking plate (group N, n = 45). In both groups, the plates were fixed to the proximal and distal clavicle with two and/or three screws, respectively. The main outcome measures were complication rates, time to bone union, and Constant score.
RESULTS


Forty-two patients in group L (mean age, 45.9 years) and 41 in group N (mean age, 43.6 years) were followed. The overall complication rates in groups L and N were 7.2% (three peri-implant fractures) and 7.3% (non-union, deformed plate, and peri-implant fracture), respectively (p = .98). The average time to union significantly differed between groups (L vs. N: 13.0 ± 4.1 vs. 17.5 ± 6.3 weeks; p < .01). However, the Constant score at the final follow-up was not significantly different between groups (L vs. N: 87.0 ± 12.3 vs. 89.8 ± 9.1).
CONCLUSIONS


Similar complication rates and clinical results were found for locking and nonlocking superior plate fixation for displaced midshaft clavicle fractures. However, the time to bone union was shorter with the locking plate. This study suggests that both plating systems are effective for treating displaced midshaft clavicle fractures.
LEVEL OF EVIDENCE


Therapeutic, level I.",2021,"CONCLUSIONS


Similar complication rates and clinical results were found for locking and nonlocking superior plate fixation for displaced midshaft clavicle fractures.","['Forty-two patients in group L (mean age, 45.9 years) and 41 in group N (mean age, 43.6 years', 'displaced midshaft clavicle fractures', '102 consecutive patients with displaced midshaft clavicle fractures (2B1 and 2B2 in Robinson classification']","['Locking versus nonlocking superior plate fixations', 'locking or nonlocking superior plate fixation', 'locking plate', 'locking and nonlocking superior plate fixation', '3.5-mm Locking Compression Plate (LCP', 'nonlocking plate']","['average time to union', 'overall complication rates', 'time to bone union', 'complication rates, time to bone union, and Constant score']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441846', 'cui_str': 'Group L'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0406737', 'cui_str': 'Robinson nail dystrophy-deafness syndrome'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",12.0,0.0388188,"CONCLUSIONS


Similar complication rates and clinical results were found for locking and nonlocking superior plate fixation for displaced midshaft clavicle fractures.","[{'ForeName': 'Yoshiyasu', 'Initials': 'Y', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan. Electronic address: y-uchi@is.icc.u-tokai.ac.jp.'}, {'ForeName': 'Akiyoshi', 'Initials': 'A', 'LastName': 'Handa', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Omi', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Shimpuku', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takatori', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.'}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2020.09.017']
226,33184642,Vitamin D in human serum and adipose tissue after supplementation.,"BACKGROUND


Serum 25-hydroxyvitamin D [25(OH)D] concentration is an indicator of vitamin D exposure, but it is also influenced by clinical characteristics that affect 25(OH)D production and clearance. Vitamin D is the precursor to 25(OH)D but is analytically challenging to measure in biological specimens.
OBJECTIVES


We aimed to develop and validate a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantification of vitamins D3 and D2 in serum and to explore the potential of circulating vitamin D as a biomarker of exposure in supplementation trials.
METHODS


The method was validated using guideline C62-A from the Clinical and Laboratory Standards Institute and was applied in 2 pilot clinical trials of oral vitamin D3 supplementation. Pilot study 1 included 22 adults randomly assigned to placebo or 2000 IU/d. Blood was collected at baseline, 1, 3, 6, and 12 mo. Pilot study 2 included 15 adults randomly assigned to 2000 or 4000 IU/d. Blood and subcutaneous (SUBQ) adipose tissue were collected at baseline and 3 mo.
RESULTS


In study 1, mean change (baseline to 3 mo) in serum vitamin D3 was -0.1 ng/mL in the placebo group and 6.8 ng/mL in the 2000 IU/d group (absolute difference: 6.9; 95% CI: 4.5, 9.3 ng/mL). In study 2, mean change (baseline to 3 mo) in serum vitamin D3 was 10.4 ng/mL in the 2000 IU/d group and 22.2 ng/mL in the 4000 IU/d group (fold difference: 2.15; 95% CI: 1.40, 3.37). Serum and adipose tissue vitamin D3 concentrations were correlated, and the dose-response of vitamin D3 in adipose mirrored that in serum.
CONCLUSIONS


We validated a sensitive, robust, and high-throughput LC-MS/MS method to quantify vitamins D3 and D2 in serum. Serum and SUBQ adipose tissue vitamin D3 concentrations increased proportionally to dose with 3 mo of daily supplementation.These trials were registered at clinicaltrials.gov as NCT00552409 (pilot study 1) and NCT01477034 (pilot study 2).",2020,"In study 1, mean change (baseline to 3 mo) in serum vitamin D3 was -0.1 ng/mL in the placebo group and 6.8 ng/mL in the 2000 IU/d group (absolute difference: 6.9; 95% CI: 4.5, 9.3 ng/mL).","['15 adults randomly assigned to 2000 or 4000 IU/d', '22 adults randomly assigned to']","['oral vitamin D3 supplementation', 'Vitamin D', 'placebo']","['Serum and SUBQ adipose tissue vitamin D3 concentrations', 'Serum and adipose tissue vitamin D3 concentrations', 'Blood and subcutaneous (SUBQ) adipose tissue', 'serum vitamin D3']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0428581', 'cui_str': 'Serum vitamin A measurement'}]",22.0,0.207433,"In study 1, mean change (baseline to 3 mo) in serum vitamin D3 was -0.1 ng/mL in the placebo group and 6.8 ng/mL in the 2000 IU/d group (absolute difference: 6.9; 95% CI: 4.5, 9.3 ng/mL).","[{'ForeName': 'Cora M', 'Initials': 'CM', 'LastName': 'Best', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Devon V', 'Initials': 'DV', 'LastName': 'Riley', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Laha', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Pflaum', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Leila R', 'Initials': 'LR', 'LastName': 'Zelnick', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hsu', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Thummel', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Foster-Schubert', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jessica N', 'Initials': 'JN', 'LastName': 'Kuzma', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Cromer', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Larson', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Derek K', 'Initials': 'DK', 'LastName': 'Hagman', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Heshelman', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Kratz', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Hoofnagle', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa295']
227,33184653,"Black American Maternal Prenatal Choline, Offspring Gestational Age at Birth, and Developmental Predisposition to Mental Illness.","Black Americans have increased risk for schizophrenia and other mental illnesses with prenatal origins. Prenatal choline promotes infant brain development and behavioral outcomes, but choline has not been specifically assessed in Black Americans. Pregnant women (N = 183, N = 25 Black Americans) enrolled in a study of prenatal stressors and interactions with prenatal choline. Black American women had lower 16-week gestation plasma choline than Whites. Lower choline was not related to obesity, income, or metabolic genotypes. Pregnant women in rural Uganda have higher choline levels than Black American women. Black Americans' lower choline was associated with higher hair cortisol, indicative of higher stress. Lower maternal choline was associated with offsprings' lower gestational age at birth and with decreased auditory P50 inhibition, a marker of inhibitory neuron development. Behavioral development was assessed on the Infant Behavior Questionnaire-R-SF (IBQ-R) at 3 months. Lower Black American maternal gestational choline was associated with lower infant IBQ-R Orienting/Regulation, indicating decreased attention and relation to caregivers. Additional evidence for developmental effects of choline in Black Americans comes from a randomized clinical trial of gestational phosphatidylcholine supplementation versus placebo that included 15 Black Americans. Phosphatidylcholine increased gestational age at birth and newborn P50 inhibition and decreased Social Withdrawn and Attention problems at 40 months of age in Black Americans' offspring compared to placebo. Inhibitory and behavioral deficits associated with lower prenatal choline in offspring of Black American women indicate potential developmental predispositions to later mental illnesses that might be ameliorated by prenatal choline or phosphatidylcholine supplementation.",2021,"Lower Black American maternal gestational choline was associated with lower infant IBQ-R Orienting/Regulation, indicating decreased attention and relation to caregivers.","['Black American Maternal Prenatal Choline, Offspring Gestational Age at Birth, and Developmental Predisposition to Mental Illness', 'Black American women had lower 16-week gestation plasma choline than Whites', 'Pregnant women (N = 183, N = 25 Black Americans) enrolled in a study of prenatal stressors and interactions with prenatal choline', 'Black Americans', 'Pregnant women in rural Uganda', 'Black American women', 'offspring of Black American women', '15 Black Americans']","['Prenatal choline', 'Phosphatidylcholine', 'placebo', 'gestational phosphatidylcholine supplementation']","['gestational age at birth and newborn P50 inhibition and decreased Social Withdrawn and Attention problems', 'choline levels', 'Infant Behavior Questionnaire-R-SF (IBQ-R', 'Behavioral development']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0219874', 'cui_str': 'p50(csk)'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242952', 'cui_str': 'Behavior, Infant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",15.0,0.0378231,"Lower Black American maternal gestational choline was associated with lower infant IBQ-R Orienting/Regulation, indicating decreased attention and relation to caregivers.","[{'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Hunter', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'M Camille', 'Initials': 'MC', 'LastName': 'Hoffman', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'McCarthy', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal and Fetal Medicine, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': ""D'Alessandro"", 'Affiliation': 'Department of Biochemistry and Molecular Genetics, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wyrwa', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Noonan', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Christians', 'Affiliation': 'Department of Anesthesiology, iC42 Clinical Research and Development, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Etheldreda', 'Initials': 'E', 'LastName': 'Nakimuli-Mpungu', 'Affiliation': 'Department of Psychiatry, School of Medicine, Makerere University College of Health Sciences. Kampala, Uganda.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Zeisel', 'Affiliation': 'Departments of Nutrition and Pediatrics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Law', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Freedman', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO.'}]",Schizophrenia bulletin,['10.1093/schbul/sbaa171']
228,33205343,Efficacy of platelet-rich plasma injections in patients with adhesive capsulitis of the shoulder.,"PURPOSE


The goal of this study is to investigate whether platelet-rich plasma (PRP) injections are effective in the management of adhesive capsulitis of the shoulder (AC). A triple-blind, randomized controlled trial was designed and conducted in a medical school hospital.
METHODS


32 adult patients with adhesive capsulitis (21 female, 11 male with a mean age of 57, ranging from 23 to 70) were included in this study. Patients had to have shoulder pain and restrictions in movements (at least 25% when compared to the other side, and at least in two directions) for three months minimum and nine months maximum. Patients were randomized to two groups, and one group took PRP injections for three times every two weeks, while the other group took saline injections in same frequency and volume. A standardized exercise program was also applied to all patients. Patients were evaluated with Shoulder Pain and Disability Index (SPADI), Visual Analogue Scales for pain and disability, ranges of movements, and use of analgesics in before, after, and third month after the initiation of the therapy.
RESULTS


Baseline comparisons between groups showed no differences. SPADI and ranges of motion in all directions showed significant improvements with therapy, and the group which took PRP injections showed better improvements when compared to the control group (p < 0.05). Visual Analogue Scale was found to be better for the PRP group after therapy and third month, and not for the control group (0.4 ± 1.06 and 0.17 ± 0.72 vs. 2.5 ± 2.6 and 2 ± 2.2, respectively, p < 0.05). Use of analgesics was not found to be significant for both groups (p > 0.05).
CONCLUSION


PRP injections were found to be effective in both pain and disability, and showed improvements in a restricted shoulder due to adhesive capsulitis. These findings might point out PRP as a therapeutic option in the management of adhesive capsulitis.",2021,"Visual Analogue Scale was found to be better for the PRP group after therapy and third month, and not for the control group (0.4 ± 1.06 and 0.17 ± 0.72 vs. 2.5 ± 2.6 and 2 ± 2.2, respectively, p < 0.05).","['patients with adhesive capsulitis of the shoulder', '32 adult patients with adhesive capsulitis (21 female, 11 male with a mean age of 57, ranging from 23 to 70', 'medical school hospital']","['PRP injections', 'standardized exercise program', 'platelet-rich plasma injections', 'platelet-rich plasma (PRP) injections']","['pain and disability', 'shoulder pain and restrictions in movements', 'Shoulder Pain and Disability Index (SPADI), Visual Analogue Scales for pain and disability, ranges of movements, and use of analgesics', 'Visual Analogue Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",32.0,0.0298473,"Visual Analogue Scale was found to be better for the PRP group after therapy and third month, and not for the control group (0.4 ± 1.06 and 0.17 ± 0.72 vs. 2.5 ± 2.6 and 2 ± 2.2, respectively, p < 0.05).","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Ünlü', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey. brc---koc@hotmail.com.'}, {'ForeName': 'Funda Atamaz', 'Initials': 'FA', 'LastName': 'Çalış', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey.'}, {'ForeName': 'Hale', 'Initials': 'H', 'LastName': 'Karapolat', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey.'}, {'ForeName': 'Asude', 'Initials': 'A', 'LastName': 'Üzdü', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey.'}, {'ForeName': 'Göksel', 'Initials': 'G', 'LastName': 'Tanıgör', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey. gtanigor@windowslive.com.'}, {'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Kirazlı', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04518-9']
229,32694482,Cryobiopsy With Radial UltraSound Guidance (CYRUS): A Pilot Randomized Controlled Study.,"BACKGROUND


Major airway bleeding is the most feared complication of transbronchial cryobiopsy (TBC). Radial endobronchial ultrasound (REBUS) has been used to assess the peripheral lung, primarily to identify pulmonary nodules, and also peripheral blood vessels. Using REBUS-guided TBC to avoid peripheral vasculature might reduce bleeding risk. This prospective randomized double-blind pilot trial was designed to investigate the feasibility of study procedures and inform the power calculation and clinical significance of a future large randomized trial.
METHODS


Consecutive TBCs were randomized to be performed with or without REBUS guidance in the same patient. A nonblinded operator obtained each biopsy while a blinded second operator managed the bleeding after each biopsy and determined when hemostasis had been obtained. Feasibility of study procedures and the ability to recruit patients were of primary interest. Time to hemostasis after each biopsy was also examined.
RESULTS


Forty TBCs were performed in 10 patients (4 biopsies per patient) over an enrollment period of 6 months. The time to control bleeding between biopsies was not statistically different between intervention and control arms [-14.3 (-120.1 to 92.0) s, P=0.7878]. Mean bleeding time was 139.4±59.895 seconds (REBUS 132.25± 89.305 s, non-REBUS 146.55±82.043 s). A trend towards the decreased grade of bleeding and less need for additional interventions was observed with REBUS use, but this difference did not reach statistical significance in this pilot investigation.
CONCLUSION


Our findings suggest that REBUS-guided TBC is feasible. We did not observe any statistically significant difference in time to hemostasis or bleeding grade in this pilot study.",2021,"Mean bleeding time was 139.4±59.895 seconds (REBUS 132.25± 89.305 s, non-REBUS 146.55±82.043 s).",['Consecutive TBCs'],"['Radial endobronchial ultrasound (REBUS', 'Cryobiopsy With Radial UltraSound Guidance (CYRUS']","['bleeding risk', 'Mean bleeding time', 'time to hemostasis or bleeding grade', 'time to control bleeding between biopsies', 'grade of bleeding']",[],"[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",40.0,0.0809112,"Mean bleeding time was 139.4±59.895 seconds (REBUS 132.25± 89.305 s, non-REBUS 146.55±82.043 s).","[{'ForeName': 'Jasleen K', 'Initials': 'JK', 'LastName': 'Pannu', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine.'}, {'ForeName': 'Lance J', 'Initials': 'LJ', 'LastName': 'Roller', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Lentz', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine.'}, {'ForeName': 'Otis B', 'Initials': 'OB', 'LastName': 'Rickman', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Aboudara', 'Affiliation': ""Department of Pulmonary Critical Care Medicine, St. Luke's Health System, University of Missouri at Kansas City, Kansas City, MO.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Maldonado', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine.'}]",Journal of bronchology & interventional pulmonology,['10.1097/LBR.0000000000000699']
230,33211508,Building empathy through motivation-based interventions.,"Empathy is associated with adaptive social and emotional outcomes; as such, a crucial outstanding question is whether it can be bolstered in ways that make practical differences in people's lives. Most empathy-building efforts address one's ability to empathize, increasing empathy by training skills like perspective taking. However, empathy is more than the ability to share and understand others' feelings; it also reflects underlying motives that drive people to experience or avoid it. As such, another strategy for increasing empathy could focus on shifting relevant motives. Here we explored this idea, leveraging two intervention techniques (mindsets and social norms) to increase motivation to empathize. Two hundred ninety-two first-year college students were randomly assigned to one of three intervention conditions-malleable mindset, social norms, or a combination of the two-or a control condition. Eight weeks later, participants in the intervention conditions endorsed stronger beliefs about empathy's malleability and exhibited greater empathic accuracy when rating others' positive emotions as compared to the control condition. They also reported having made a greater number of friends since starting college. The interventions did not affect outcomes related to intergroup processes or empathic accuracy when rating others' negative emotions, indicating a boundary condition for these interventions. This experiment underscores the potential of motivation-based empathy interventions to generate positive, real-world impact. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"The interventions did not affect outcomes related to intergroup processes or empathic accuracy when rating others' negative emotions, indicating a boundary condition for these interventions.",['Two hundred ninety-two first-year college students'],"['intervention conditions-malleable mindset, social norms, or a combination of the two-or a control condition']",['empathic accuracy'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0342782,"The interventions did not affect outcomes related to intergroup processes or empathic accuracy when rating others' negative emotions, indicating a boundary condition for these interventions.","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Weisz', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Desmond C', 'Initials': 'DC', 'LastName': 'Ong', 'Affiliation': 'Department of Information Systems and Analytics, National University of Singapore.'}, {'ForeName': 'Ryan W', 'Initials': 'RW', 'LastName': 'Carlson', 'Affiliation': 'Department of Psychology, Yale University.'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Zaki', 'Affiliation': 'Department of Psychology, Stanford University.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000929']
231,33215669,Gait Retraining Improves Running Impact Loading and Function in Previously Injured U.S. Military Cadets: A Pilot Study.,"INTRODUCTION


Running-related musculoskeletal injury (RRI) among U.S. military service members continues to negatively impact force readiness. There is a paucity of evidence supporting the use of RRI interventions, such as gait retraining, in military populations. Gait retraining has demonstrated effectiveness in altering running biomechanics and reducing running load. The purpose of this pilot study was to investigate the clinical effect of a gait retraining intervention on a military cadet population recovering from a lower-extremity RRI.
MATERIALS AND METHODS


The study design is a pilot study. Before study initiation, institutional approval was granted by the Keller Army Community Hospital Office of Human Research Protections. Nine rearfoot strike (RFS) runners recovering from a lower-extremity RRI at the U.S. Military Academy were prospectively enrolled and completed a gait retraining intervention. Participants followed-up with their assigned medical provider 6 times over 10 weeks for a clinical evaluation and running gait retraining. Gait retraining was provided utilizing verbal, visual, and audio feedback to facilitate a change in running foot strike pattern from RFS to non-rearfoot strike (NRFS) and increase preferred running step rate. At pre-intervention and post-intervention running ground reaction forces (GRF) [average vertical loading rate (AVLR), peak vertical GRF], kinematic (foot strike pattern) and temporospatial (step rate, contact time) data were collected. Participants self-reported their level of function via the Single Assessment Numeric Evaluation, Patient-Specific Functional Scale, and total weekly running minutes. Paired samples t-tests and Wilcoxon signed rank tests were used to compare pre- and post-intervention measures of interest. Values of P < .05 were considered statistically significant.
RESULTS


Nine patients completed the 10-week intervention (age, 20.3 ± 2.2 years; height, 170.7 ± 13.8 cm; mass, 71.7 ± 14.9 kg; duration of injury symptoms, 192.4 ± 345.5 days; running speed, 2.8 ± 0.38 m/s). All nine runners (100%) transitioned from RFS to NRFS. Left AVLR significantly decreased from 60.3 ± 17.0 bodyweight per second (BW/s) before intervention to 25.9 ± 9.1 BW/s after intervention (P = 0.008; effect size (d) = 2.5). Right AVLR significantly decreased from 60.5 ± 15.7 BW/s to 32.3 ± 12.5 BW/s (P < .001; d = 2.0). Similarly, step rate increased from 169.9 ± 10.0 steps per minute (steps/min) before intervention to 180.5 ± 6.5 steps/min following intervention (P = .005; d = 1.3). Single Assessment Numeric Evaluation scores improved significantly from 75 ± 23 to 100 ± 8 (P = .008; d = 1.5) and Patient-Specific Functional Scale values significantly improved from 6 ± 2.3 to 9.5 ± 1.6 (P = .007; d = 1.8) after intervention. Peak vertical GRF (left, P = .127, d = 0.42; right, P = .052, d = 0.53), contact time (left, P = 0.127, d = 0.42; right, P = 0.052, d = 0.53), and total weekly continuous running minutes (P = 0.095, d = 0.80) remained unchanged at post-intervention. All 9 patients remained injury free upon a 6-month medical record review.
CONCLUSIONS


In 9 military service members with a RRI, a 10-week NRFS gait retraining intervention was effective in improving running mechanics and measures of function. Patients remained injury-free 6 months following enrollment. The outcomes of this pilot study suggest that individuals recovering from certain lower-extremity RRIs may benefit from transitioning to an NRFS running pattern.",2021,Single Assessment Numeric Evaluation scores improved significantly from 75 ± 23 to 100 ± 8 (P = .008; d = 1.5) and Patient-Specific Functional Scale values significantly improved from 6 ± 2.3 to 9.5 ± 1.6 (P = .007; d = 1.8) after intervention.,"['All 9 patients remained injury free upon a 6-month medical record review', 'Nine patients completed the 10-week intervention (age, 20.3\u2009±\u20092.2 years; height, 170.7\u2009±\u200913.8 cm; mass, 71.7\u2009± 14.9 kg; duration of injury symptoms, 192.4\u2009±\u2009345.5 days; running speed, 2.8\u2009±\u20090.38 m/s', 'Nine rearfoot strike (RFS) runners recovering from a lower-extremity RRI at the U.S. Military Academy', 'military cadet population recovering from a lower-extremity RRI', '9 military service members with a RRI']","['NRFS gait retraining intervention', 'clinical evaluation and running gait retraining', 'gait retraining intervention', 'Gait retraining was provided utilizing verbal, visual, and audio feedback to facilitate a change in running foot strike pattern from RFS to non-rearfoot strike (NRFS', 'Gait retraining', 'Gait Retraining']","['level of function via the Single Assessment Numeric Evaluation, Patient-Specific Functional Scale, and total weekly running minutes', 'Right AVLR', 'step rate', 'contact time', 'Patient-Specific Functional Scale values', 'Peak vertical GRF', 'vertical loading rate (AVLR), peak vertical GRF], kinematic (foot strike pattern) and temporospatial (step rate, contact time) data', 'Left AVLR', 'Single Assessment Numeric Evaluation scores', 'running mechanics and measures of function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0730229', 'cui_str': 'Medical records review'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C4517456', 'cui_str': '0.38'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}]","[{'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C2936182', 'cui_str': 'Audio Feedback'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",9.0,0.0503972,Single Assessment Numeric Evaluation scores improved significantly from 75 ± 23 to 100 ± 8 (P = .008; d = 1.5) and Patient-Specific Functional Scale values significantly improved from 6 ± 2.3 to 9.5 ± 1.6 (P = .007; d = 1.8) after intervention.,"[{'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Miller', 'Affiliation': 'Keller Army Community Hospital Division I Sports Physical Therapy Fellowship, Keller Army Community Hospital, West Point, NY 10996, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Crowell', 'Affiliation': 'Keller Army Community Hospital Division I Sports Physical Therapy Fellowship, Keller Army Community Hospital, West Point, NY 10996, USA.'}, {'ForeName': 'Jamie B', 'Initials': 'JB', 'LastName': 'Morris', 'Affiliation': 'Army-Baylor Doctorate of Physical Therapy Program, United States Army Medical Center of Excellence,Fort Sam Houston, TX 78234, USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Mason', 'Affiliation': 'Keller Army Community Hospital Division I Sports Physical Therapy Fellowship, Keller Army Community Hospital, West Point, NY 10996, USA.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Zifchock', 'Affiliation': 'Department of Civil and Mechanical Engineering, United States Military Academy, West Point, NY 10996, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Goss', 'Affiliation': 'Department of Physical Therapy, One University Parkway, High Point University, High Point, NC 27268, USA.'}]",Military medicine,['10.1093/milmed/usaa383']
232,32689839,Inspiratory Muscle Training Potentiates the Beneficial Effects of Proportional Assisted Ventilation on Exertional Dyspnea and Exercise Tolerance in COPD: A Proof-of-Concept Randomized and Controlled Trial.,"During pulmonary rehabilitation, a subset of subjects with COPD requires adjunct therapy to achieve high-intensity training. Both noninvasive ventilation (NIV) and inspiratory muscle training (IMT) are available to assist these subjects. We aimed to prime the respiratory muscles before NIV with IMT, anticipating additive effects for maximal exercise tolerance ( T   lim ) and dyspnea/leg fatigue relief throughout the exercise as primary outcomes. Changes in the respiratory pattern were secondary outcomes. COPD subjects performed a total of four identical constant work rate tests on a cycle ergometer at 75% of maximum work rate, under control ventilation (SHAM, 4 cm H 2 O) or proportional assisted ventilation (PAV, individually adjusted), before and after 10 sessions of high-intensity IMT (three times/week) during 30 days. Two-way RM ANOVA with appropriate corrections were performed. Final analysis in nine subjects showed improved  T   lim  (Δ = 111 s) and lower minute-ventilation (Δ = 4 L . min -1 ) at exhaustion, when comparing the IMT effects within the PAV modality ( p =  0.001 and  p =  0.036, respectively) and improved  T   lim  for PAV  vs.  SHAM (PAV main-effect,  p  = 0.001; IMT main-effect,  p  = 0.006; PAV  vs.  IMT interaction,  p  = 0.034). In addition, IMT + PAV association, compared to PAV alone, resulted in lower respiratory frequency (IMT main-effect,  p  = 0.009; time main-effect,  p  < 0.0001; IMT  vs.  time interaction,  p  = 0.242) and lower inspiratory time related to duty cycle (IMT main-effect,  p  = 0.018; time main-effect,  p  = 0.0001; IMT  vs.  time interaction,  p  = 0.004) throughout exercise. The addition of IMT prior to a PAV-supported aerobic bout potentiates exercise tolerance and dyspnea relief and induces favourable changes in ventilatory pattern in severe COPD during high-intensity training ( Brazilian Registry of Clinical Trials ,  number  RBR-6n3dzz).",2020,"min -1 ) at exhaustion, when comparing the IMT effects within the PAV modality ( p =  0.001 and  p =  0.036, respectively) and improved  T   lim  for PAV  vs.  SHAM","['COPD subjects', 'COPD']","['control ventilation (SHAM, 4\u2009cm H 2 O) or proportional assisted ventilation', 'SHAM', 'noninvasive ventilation (NIV) and inspiratory muscle training (IMT', 'Proportional Assisted Ventilation', 'Inspiratory Muscle Training', 'IMT']","['lower minute-ventilation', 'Exertional Dyspnea and Exercise Tolerance', 'maximal exercise tolerance ( T   lim ) and dyspnea/leg fatigue relief', 'lower inspiratory time related to duty cycle (IMT main-effect']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0419011', 'cui_str': 'Controlled ventilation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C3178855', 'cui_str': 'Proportional Assist Ventilation'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0449205', 'cui_str': 'LIM'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0428686', 'cui_str': 'Inspiratory time'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0682771,"min -1 ) at exhaustion, when comparing the IMT effects within the PAV modality ( p =  0.001 and  p =  0.036, respectively) and improved  T   lim  for PAV  vs.  SHAM","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Koch', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Tiago Rodrigues de Lemos', 'Initials': 'TRL', 'LastName': 'Augusto', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Alessandro Gomes', 'Initials': 'AG', 'LastName': 'Ramos', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Paulo de Tarso', 'Initials': 'PT', 'LastName': 'Müller', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}]",COPD,['10.1080/15412555.2020.1789085']
233,32693660,Efficacy of a 3-year course of sublingual immunotherapy for mite-induced allergic rhinitis with a 3-year follow-up.,"Aim:  To evaluate the long-term efficacy of sublingual immunotherapy (SLIT) in treating mite-sensitized allergic rhinitis (AR).  Materials & methods:  150 AR children were randomly divided into SLIT and pharmacotherapy (PT) groups, receiving a 3-year course of SLIT along with PT or PT only.  Results:  The symptom and medication scores at the 3- and 6-year follow-up were significantly lower compared with the baseline levels in both groups, while the values were significantly lower in SLIT group than in PT group. No significant differences were observed between 3- and 6-year follow-up in SLIT group.  Conclusion:  3-year SLIT along with PT appeared more effective compared with PT only for mite-induced AR in children, and the treatment was effective for at least 3 consecutive years even after SLIT ceased.",2020,"The symptom and medication scores at the 3- and 6-year follow-up were significantly lower compared with the baseline levels in both groups, while the values were significantly lower in SLIT group than in PT group.","['150\xa0AR children', 'treating mite-sensitized allergic rhinitis (AR', 'mite-induced allergic rhinitis with a 3-year follow-up']","['sublingual immunotherapy', 'sublingual immunotherapy (SLIT', 'SLIT', 'SLIT and pharmacotherapy (PT)\xa0groups, receiving a 3-year course of SLIT along with PT or PT only']",['symptom and medication scores'],"[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0026231', 'cui_str': 'Mite'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0113851,"The symptom and medication scores at the 3- and 6-year follow-up were significantly lower compared with the baseline levels in both groups, while the values were significantly lower in SLIT group than in PT group.","[{'ForeName': 'Wen-Bo', 'Initials': 'WB', 'LastName': 'Chen', 'Affiliation': ""Department of Otorhinolaryngology, Children's Hospital of Nanjing Medical University, 72 Guangzhou Road, Nanjing 210008, China.""}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Shen', 'Affiliation': ""Department of Otorhinolaryngology, Children's Hospital of Nanjing Medical University, 72 Guangzhou Road, Nanjing 210008, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Otorhinolaryngology, Children's Hospital of Nanjing Medical University, 72 Guangzhou Road, Nanjing 210008, China.""}, {'ForeName': 'Wen-Cheng', 'Initials': 'WC', 'LastName': 'Zhou', 'Affiliation': 'Department of Otorhinolaryngology, The First Affiliated Hospital, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Otorhinolaryngology, The First Affiliated Hospital, Nanjing Medical University, Nanjing 210029, China.'}]",Immunotherapy,['10.2217/imt-2020-0006']
234,32691298,Effect of drain application on postoperative complaints after surgical removal of impacted wisdom teeth-a randomized observer-blinded split-mouth clinical trial.,"OBJECTIVES


The aim of this randomized observer-blinded split-mouth-study is to objectively assess the influence of a rubber drain on postoperative swelling using 3D face scans as measurement method and additionally evaluate pain, trismus and complications after the osteotomy of lower third molars.
MATERIAL AND METHODS


Seventy-two patients with symmetrically impacted lower wisdom teeth were recruited. Before the operation, patients rated pain using the visual analogue scale, the interincisal distance was measured, and 3D face scans were taken with an optical scanner. Each patient underwent two procedures which were at least 30 days apart. On one side, a rubber drain was inserted randomly before closure, the contralateral control side was closed without drainage. On the third and tenth postoperative day, face scans to quantify the swelling, pain evaluation and trismus measurements were performed. Due to loss of follow-up, 32 patients were excluded which resulted in 40 out of 72 patients remaining in the study.
RESULTS


There was no statistical difference in using a drain on swelling and trismus on the third and tenth day (p > 0.05). Pain was slightly worse on the third day on the treatment side, but the difference was not significant (p > 0.05). We observed no differences in the number of wound infections.
CONCLUSIONS


The insertion of a rubber drain does not have any influence on swelling, pain or trismus and has no impact on the number of wound infections.
CLINICAL RELEVANCE


The use of a rubber drain cannot be recommended as no reduction of postoperative discomfort was detected.",2021,"The insertion of a rubber drain does not have any influence on swelling, pain or trismus and has no impact on the number of wound infections.
","['postoperative complaints after surgical removal of impacted wisdom teeth', 'Seventy-two patients with symmetrically impacted lower wisdom teeth were recruited', '32 patients were excluded which resulted in 40 out of 72 patients remaining in the study']","['drain application', 'rubber drain']","['rated pain using the visual analogue scale, the interincisal distance', 'Pain', 'swelling, pain or trismus', 'number of wound infections', 'swelling, pain evaluation and trismus measurements', 'pain, trismus and complications', 'swelling and trismus', 'postoperative discomfort']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0398942', 'cui_str': 'Surgical removal of impacted third molar tooth'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",72.0,0.113895,"The insertion of a rubber drain does not have any influence on swelling, pain or trismus and has no impact on the number of wound infections.
","[{'ForeName': 'Marie Sophie', 'Initials': 'MS', 'LastName': 'Katz', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelstraße 30, 52074, Aachen, Germany. mkatz@ukaachen.de.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Peters', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Elvers', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Winterhalder', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kniha', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Stephan Christian', 'Initials': 'SC', 'LastName': 'Möhlhenrich', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hölzle', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Modabber', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelstraße 30, 52074, Aachen, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03464-5']
235,32712663,Cost-effectiveness of Preemptive Therapy Versus Prophylaxis in a Randomized Clinical Trial for the Prevention of Cytomegalovirus Disease in Seronegative Liver Transplant Recipients With Seropositive Donors.,"BACKGROUND


The relative costs of preemptive therapy (PET) or prophylaxis for the prevention of cytomegalovirus (CMV) disease in high-risk donor CMV-seropositive/recipient-seronegative (D+/R-) liver transplant recipients have not been assessed in the context of a randomized trial.
METHODS


A decision tree model was constructed based on the probability of outcomes in a randomized controlled trial that compared valganciclovir as PET or prophylaxis for 100 days in 205 D+/R- liver transplant recipients. Itemized costs for each site were obtained from a federal cost transparency database. Total costs included costs of implementation of the strategy and CMV disease treatment-related costs. Net cost per patient was estimated from the decision tree for each strategy.
RESULTS


PET was associated with a 10% lower absolute rate of CMV disease (9% vs 19%). The cost of treating a case of CMV disease in our patients was $88 190. Considering cost of implementation of strategy and treatment-related cost for CMV disease, the net cost-savings per patient associated with PET was $8707 compared to prophylaxis. PET remained cost-effective across a range of assumptions (varying costs of monitoring and treatment, and rates of disease).
CONCLUSIONS


PET is the dominant CMV prevention strategy in that it was associated with lower rates of CMV disease and lower overall costs compared to prophylaxis in D+/R- liver transplant recipients. Costs were driven primarily by more hospitalizations and higher CMV disease-associated costs due to delayed onset postprophylaxis disease in the prophylaxis group.",2021,Costs were driven primarily by more hospitalizations and higher CMV disease-associated costs due to delayed onset post-prophylaxis disease in the prophylaxis group.,"['D+R- liver transplant recipients', '205 D+R- liver transplant recipients', 'seronegative liver transplant recipients with seropositive donors']","['preemptive therapy (PET', 'valganciclovir', 'preemptive therapy versus prophylaxis']","['absolute rate of CMV disease', 'Cost effectiveness', 'Total costs included costs of implementation of the strategy and CMV disease treatment-related costs']","[{'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0318992,Costs were driven primarily by more hospitalizations and higher CMV disease-associated costs due to delayed onset post-prophylaxis disease in the prophylaxis group.,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'University of Pittsburgh and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Drew J', 'Initials': 'DJ', 'LastName': 'Winston', 'Affiliation': 'University of California, Los Angeles Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Raymund R', 'Initials': 'RR', 'LastName': 'Razonable', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'G Marshall', 'Initials': 'GM', 'LastName': 'Lyon', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Fernanda P', 'Initials': 'FP', 'LastName': 'Silveira', 'Affiliation': 'University of Pittsburgh and University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Marilyn M', 'Initials': 'MM', 'LastName': 'Wagener', 'Affiliation': 'University of Pittsburgh and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ajit P', 'Initials': 'AP', 'LastName': 'Limaye', 'Affiliation': 'University of Washington, Seattle, Washington, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1051']
236,32709586,Zataria multiflora induced bronchodilatoion comparable to theophylline syrup in asthmatic patients.,"OBJECTIVE


The bronchodilatory effect of hydro-ethanolic extract of Z. multiflora was examined in asthmatic patients.
DESIGN


Pulmonary function tests (PFTs) were measured before and 15, 30, 60, 90, 120, 150, and 180 min after administration of the extract (20 mg/kg) in 18 asthmatics and after theophylline syrup (6 mg/kg) in 12 patients.
MAIN OUTCOME MEASURES


The extract of Z. multiflora significantly increased all PFT values, 30 to 180 min post-administration similar to the effect of theophylline (all, p<0.001). Increased PFT values due to the extract were significantly declined 180 min but the effects of theophylline were declined 150 min after administration (p<0.05 to p<0.001). Values of PFTs at baseline, 30 and 180 min after drugs administration were not singnificantly different between the extract and theophylline.
CONCLUSIONS


Z. multiflora showed a bronchodilatory effect in asthmatic patients comparable to theophylline effect but with a longer duration of action.",2021,"The extract of Z. multiflora significantly increased all PFT values, 30 to 180 min post-administration similar to the effect of theophylline (all, p<0.001).",['asthmatic patients'],"['theophylline', 'hydro-ethanolic extract', 'theophylline syrup']","['PFT values', 'Values of PFTs']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039771', 'cui_str': 'Theophylline'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1248150', 'cui_str': 'Theophylline Oral Solution'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0439761,"The extract of Z. multiflora significantly increased all PFT values, 30 to 180 min post-administration similar to the effect of theophylline (all, p<0.001).","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Boskabady', 'Affiliation': 'Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Alavinezhad', 'Affiliation': 'Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Boskabady', 'Affiliation': 'Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran; Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: boskabadymh@mums.ac.ir.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.07.002']
237,32744473,The transformative effects of a participatory social empowerment intervention in the MAISHA intimate partner violence trial in Tanzania.,"Intimate partner violence is an important public health problem, with far-reaching consequences for women's physical and emotional health and social well-being. There is evidence that intimate partner violence is preventable. The MAISHA study, a randomised controlled trial of the impact of a gender training intervention on intimate partner violence for women in Tanzania, found that those who participated in gender training were less likely to report past-year physical violence. As part of the study, a sample of women participated in longitudinal qualitative enquiry. To better understand the processes of change associated with intimate partner violence prevention, we explored narratives from in-depth interviews and focus group discussions with women who had participated in the training. The study drew on feminist political theory on agency and change, which we sought to understand in a setting with high rates of intimate partner violence that a standalone intervention was unlikely to change. The study found that gender training, which seeks to develop political consciousness and transformation, can promote a sense of efficacy amongst participants who feel validated through the collective learning process. Important yet under examined cognitive elements of change processes deserve more attention in the design, delivery and evaluation of violence prevention gender training.",2021,"The MAISHA study, a randomised controlled trial of the impact of a gender training intervention on intimate partner violence for women in Tanzania, found that those who participated in gender training were less likely to report past-year physical violence.","['intimate partner violence for women in Tanzania, found that those who participated in gender training were less likely to report past-year physical violence', 'women participated in longitudinal qualitative enquiry', 'MAISHA intimate partner violence trial in Tanzania', 'participants who feel validated through the collective learning process', 'women who had participated in the training']","['participatory social empowerment intervention', 'standalone intervention', 'gender training intervention']",[],"[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0255634,"The MAISHA study, a randomised controlled trial of the impact of a gender training intervention on intimate partner violence for women in Tanzania, found that those who participated in gender training were less likely to report past-year physical violence.","[{'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Lees', 'Affiliation': 'Department of Global and Health Development, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Marchant', 'Affiliation': 'Department of Global and Health Development, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Selestine', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Mshana', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania.'}, {'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Harvey', 'Affiliation': 'Department of Global and Health Development, London School of Hygiene and Tropical Medicine, London, UK.'}]","Culture, health & sexuality",['10.1080/13691058.2020.1779347']
238,32719050,Online supplementation for teaching evidence-based medicine: feasibility of a randomised-controlled trial.,"BACKGROUND AND OBJECTIVES


As teaching technology advances, medical education is increasingly using digital mediums and exploring instructional models such as the flipped classroom and blended learning courses, where the in-class taught sessions are more groups on content delivered before class. Early evidence suggests lectures and foundational material can be equally provided online, but we have low-quality research to be convinced. We aim to test and develop an online evidence-based teaching resource that seeks to improve the availability and scalability of evidence-based medicine (EBM) learning tools. We evaluate the feasibility of a study design that could test for changes in academic performance in EBM skills using an online supplement.
METHODS


Mixed-methods feasibility study of a randomised controlled trial (RCT) in an undergraduate medical student cohort.
RESULTS


Of a small cohort (n=34), eight participants agreed to randomisation and completed the study. No study participant completed the EBM supplementary course in full. Students report time-management as a significant barrier in participation, and all aspects of the study and communications should be delivered with efficiency a key consideration.
CONCLUSION


Randomising students to an online EBM supplement within a medical school programme presents challenges of recruitment and student motivation, but the study design is potentially feasible.",2021,We aim to test anddevelop an online evidence-based teaching resource that seeks to improve theavailability and scalability of evidence-based medicine (EBM) learning tools.,"['undergraduate medical student cohort', 'Of a small cohort (n=34']",['Online supplementation'],[],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",[],,0.153404,We aim to test anddevelop an online evidence-based teaching resource that seeks to improve theavailability and scalability of evidence-based medicine (EBM) learning tools.,"[{'ForeName': 'Marcy C', 'Initials': 'MC', 'LastName': 'McCall', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK marcy.mccall@phc.ox.ac.uk.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Fanshawe', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCartney', 'Affiliation': 'Medical Sciences Division, Oxford University, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Damion', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'Medical Sciences Division, Oxford University, Oxford, Oxfordshire, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nunan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Heneghan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2020-111372']
239,32734564,Intermittent pneumatic compression combined with rehabilitation training improves motor function deficits in patients with acute cerebral infarction.,"To investigate the effect of intermittent pneumatic compression (IPC) combined with rehabilitation training on patients with acute cerebral infarction and motor impairment, seventy-four patients with acute cerebral infarction and hemiplegia were randomly and equally divided into two groups, the control group and the IPC treatment group. The patients in the control group received conventional drug therapy and rehabilitation training, and the patients in the treatment group received the IPC treatment in addition to the treatment given in the control group. Motor function, the primary outcome, of the two groups was evaluated by Fugl-Meyer motor function scores. The Barthel index assessment scale was used to evaluate the ability to perform activities of daily living of the two groups, as a secondary outcome. All these indicators were collected and compared before treatment and at 7 days, 14 days, and 30 days after treatment. The incidence of adverse reactions associated with treatment was also recorded. At 7, 14, and 30 days after treatment, the Fugl-Meyer scores (27.16 ± 7.37, 33.41 ± 7.16 and 38.72 ± 7.65) and Barthel scores (47.16 ± 7.37, 52.41 ± 7.16, and 56.09 ± 8.32) of the treatment group were also significantly higher than those (23.65 ± 3.11, 26.13 ± 3.25, and 28.75 ± 5.92; 44.15 ± 3.11, 46.63 ± 3.25 and 47.75 ± 4.22) of the control group (all P < 0.05). With the extension of follow-up time, both scores were higher. There were no treatment-related adverse events in either of the two groups of patients during or after treatment. In conclusion, the IPC combined with rehabilitation training can effectively improve motor function deficits, the ability to perform activities of daily living, and quality of life for patients.",2021,There were no treatment-related adverse events in either of the two groups of patients during or after treatment.,"['patients with acute cerebral infarction', 'patients with acute cerebral infarction and motor impairment,\xa0seventy-four patients with acute cerebral infarction and hemiplegia']","['Intermittent pneumatic compression combined with rehabilitation training', 'intermittent pneumatic compression (IPC) combined with rehabilitation training', 'IPC treatment', 'conventional drug therapy and rehabilitation training', 'IPC combined with rehabilitation training']","['Barthel scores', 'Fugl-Meyer scores', 'adverse reactions', 'adverse events', 'motor function deficits', 'Fugl-Meyer motor function scores', 'activities of daily living, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",74.0,0.020727,There were no treatment-related adverse events in either of the two groups of patients during or after treatment.,"[{'ForeName': 'Jiangshan', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Department of Neurology, Hongze Huai'an District People's Hospital, No.1 Huanghe West Road, Huai'an, 223300, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""ICU, The Second People's Hospital of Huai'an, The Affiliated Huai'an Hospital of Xuzhou Medical University, No.62 Huaihai South Road, Huai'an, 223002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': ""Department of Neurology, Huai'an First People's Hospital, the Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University, Huai'an, 223300, Jiangsu, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Huai'an, The Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an, 223002, Jiangsu, China.""}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Huai'an, The Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an, 223002, Jiangsu, China.""}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Han', 'Affiliation': ""Department of Neurology, Huai'an First People's Hospital, the Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University, Huai'an, 223300, Jiangsu, China. dahuihui19830809@163.com.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Huai'an, The Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an, 223002, Jiangsu, China. dr_shenjun79@126.com.""}]",Acta neurologica Belgica,['10.1007/s13760-020-01414-2']
240,32735653,Efficacy of Bezlotoxumab in Trial Participants Infected With Clostridioides difficile Strain BI Associated With Poor Outcomes.,"BACKGROUND


Bezlotoxumab reduced rates of recurrent Clostridioides difficile infection (rCDI) vs placebo in Monoclonal Antibodies for C. difficile Therapy (MODIFY) I/II trial participants receiving antibacterial drug treatment for CDI. A secondary objective of MODIFY I/II was to assess bezlotoxumab's efficacy against C. difficile strains associated with increased rates of morbidity and mortality.
METHODS


In this post-hoc analysis of pooled MODIFY I/II data, efficacy endpoints were assessed in participants infected with restriction endonuclease analysis BI and non-BI strains of C. difficile at study entry. Treatment outcomes were compared between participants receiving bezlotoxumab (alone or with actoxumab [B, B+A]) and those receiving no bezlotoxumab (placebo or actoxumab [P, A]).
RESULTS


From 2559 randomized participants, C. difficile was isolated from 1588 (67.2%) baseline stool samples. Participants with BI strains (n = 328) were older and had more risk factors for rCDI than non-BI strain participants (n = 1260). There were no differences in initial clinical cure rate between BI and non-BI strains in either group. The rCDI rate for BI strains treated with bezlotoxumab was lower than for the no bezlotoxumab group (B, B+A vs P, A: 23.6% vs 43.9%) and was also lower for the non-BI strains (B, B+A vs P, A: 21.4% vs 36.1%). Rates of 30-day CDI-associated rehospitalization were greater with BI vs non-BI strains in both groups.
CONCLUSIONS


Infection with BI strains of C. difficile predicted poor outcomes in the MODIFY I/II trials. Bezlotoxumab (alone or with actoxumab) treatment was effective both in BI and non-BI subpopulations.",2021,"From 2559 randomized participants, C. difficile was isolated from 1588 (67.2%) baseline stool samples.","['trial participants infected with Clostridioides difficile strain BI associated with poor outcomes', 'From 2559 randomized participants, C. difficile was isolated from 1588 (67.2%) baseline stool samples', 'Participants with BI strains (n=328) were older and had more risk factors for rCDI than non-BI strain participants (n=1260', 'participants receiving antibacterial drug treatment for CDI']","['MODIFY', 'bezlotoxumab (placebo or actoxumab', 'Bezlotoxumab (B, B+A', 'bezlotoxumab', 'bezlotoxumab (alone or with actoxumab: B, B+A', 'placebo']","['rates of morbidity and mortality', 'rCDI rates', 'Rates of 30-day CDI-associated re-hospitalization', 'initial clinical cure rate']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282601', 'cui_str': 'Compact Disk Interactive'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4291320', 'cui_str': 'bezlotoxumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4308583', 'cui_str': 'actoxumab'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282601', 'cui_str': 'Compact Disk Interactive'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",2559.0,0.136694,"From 2559 randomized participants, C. difficile was isolated from 1588 (67.2%) baseline stool samples.","[{'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Edward Hines, Jr. VA Hospital, Hines, Illinois, USA.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Citron', 'Affiliation': 'R. M. Alden Research Laboratory, Culver City, California, USA.'}, {'ForeName': 'Dale N', 'Initials': 'DN', 'LastName': 'Gerding', 'Affiliation': 'Edward Hines, Jr. VA Hospital, Hines, Illinois, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Leeds Teaching Hospital, Leeds, United Kingdom.'}, {'ForeName': 'Ellie J C', 'Initials': 'EJC', 'LastName': 'Goldstein', 'Affiliation': 'R. M. Alden Research Laboratory, Culver City, California, USA.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Sambol', 'Affiliation': 'Edward Hines, Jr. VA Hospital, Hines, Illinois, USA.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Best', 'Affiliation': 'Leeds Teaching Hospital, Leeds, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Eves', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Jensen', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1035']
241,32709430,"Yoga in Burn: Role of pranayama breathing exercise on pulmonary function, respiratory muscle activity and exercise tolerance in full-thickness circumferential burns of the chest.","BACKGROUND


Circumferential burn of chest (CBC) is a significant type of burn and considers as a major cause of restrictive lung disease (RLD). Patient who has CBC with RLD leads to respiratory symptoms such as breathing difficulty, airway obstruction, reduced exercise capacity and altered pulmonary functions. However, studies examining the role of pranayama breathing exercise on pulmonary function, respiratory muscle activity and exercise tolerance in full thickness circumferential burn of chest are lacking.
OBJECTIVE


To find the short term effects of pranayama breathing exercise on pulmonary function, respiratory muscle activity and exercise tolerance in full thickness circumferential burns of chest.
METHODS


Through simple random sampling method thirty subjects (N = 30) with RLD following CBC were allocated to pranayama breathing exercise group (PBE-G; n = 15) and conventional breathing exercise group (CBE-G; n = 15). They received pranayama breathing exercise and conventional breathing exercise for 4 weeks respectively. All the subjects received chest mobility exercise as common treatment. Primary (Numeric Pain Rating Scale - NPRS, forced expiratory volume (FEV1), forced vital capacity (FVC) and maximum voluntary ventilation (MVV) and secondary (Electromyogram of sternocleidomastoid, scalene, external intercostal and diaphragm muscle, 6 min walk test & Global Rating of Change - GRC) outcome measures were measured at baseline, after four weeks and after three months follow up.
RESULTS


Baseline demographic and clinical variables show homogenous distribution between the groups (p > 0.05). Four weeks following different breathing exercises, PBE-G group shows more significant changes in pain intensity, pulmonary function, respiratory muscle activity, exercise tolerance and global rating of change than CBE-G group (p ≤ 0.05) at four weeks and three months follow up.
CONCLUSION


Both groups showed improvement over time. However, differences between the groups were noticed small. Still physiotherapy management, which included pranayama breathing exercises with chest mobilization program, had an effective strategy in the treatment of restrictive lung disease following circumferential burn of chest.",2021,"Four weeks following different breathing exercises, PBE-G group shows more significant changes in pain intensity, pulmonary function, respiratory muscle activity, exercise tolerance and global rating of change than CBE-G group (p ≤ 0.05) at four weeks and three months follow up.
","['full-thickness circumferential burns of the chest', 'thirty subjects (N = 30) with RLD following CBC', 'Yoga in Burn', 'full thickness circumferential burns of chest']","['pranayama breathing exercise and conventional breathing exercise', 'conventional breathing exercise', 'pranayama breathing exercises with chest mobilization program', 'pranayama breathing exercise', 'chest mobility exercise']","['Primary (Numeric Pain Rating Scale - NPRS, forced expiratory volume (FEV1), forced vital capacity (FVC) and maximum voluntary ventilation (MVV) and secondary (Electromyogram of sternocleidomastoid, scalene, external intercostal and diaphragm muscle, 6 min walk test & Global Rating of Change - GRC) outcome measures', 'pulmonary function, respiratory muscle activity and exercise tolerance', 'pain intensity, pulmonary function, respiratory muscle activity, exercise tolerance and global rating of change']","[{'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0085581', 'cui_str': 'Restrictive lung disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0740396', 'cui_str': 'Chest burning'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0024967', 'cui_str': 'Maximum voluntary ventilation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",30.0,0.0228202,"Four weeks following different breathing exercises, PBE-G group shows more significant changes in pain intensity, pulmonary function, respiratory muscle activity, exercise tolerance and global rating of change than CBE-G group (p ≤ 0.05) at four weeks and three months follow up.
","[{'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia. Electronic address: physio_gopal@rediffmail.com.'}, {'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia; Department of Physical Therapy, Kasr Al-Aini Hospital, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Elshehawy', 'Affiliation': 'Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt; Department of Physical Therapy, Faculty of Applied Medical Sciences, Tabuk University, Tabuk, Saudi Arabia.'}, {'ForeName': 'Heba H', 'Initials': 'HH', 'LastName': 'Eltrawy', 'Affiliation': 'Department of Chest Diseases, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abodonya', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Al-Azhar University, Cairo, Egypt; Department of Surgery, College of Medicine, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Ayman K', 'Initials': 'AK', 'LastName': 'Saleh', 'Affiliation': 'Department of Surgery, College of Medicine, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia; Department of Orthopedic, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ramadan S', 'Initials': 'RS', 'LastName': 'Hussein', 'Affiliation': 'Department of Surgery, College of Medicine, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.06.033']
242,32719355,Preferential inhibition of adaptive immune system dynamics by glucocorticoids in patients after acute surgical trauma.,"Glucocorticoids (GC) are a controversial yet commonly used intervention in the clinical management of acute inflammatory conditions, including sepsis or traumatic injury. In the context of major trauma such as surgery, concerns have been raised regarding adverse effects from GC, thereby necessitating a better understanding of how GCs modulate the immune response. Here we report the results of a randomized controlled trial (NCT02542592) in which we employ a high-dimensional mass cytometry approach to characterize innate and adaptive cell signaling dynamics after a major surgery (primary outcome) in patients treated with placebo or methylprednisolone (MP). A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments. By contrast, key innate signaling responses previously associated with pain and functional recovery after surgery, including STAT3 and CREB phosphorylation, are not affected by MP. These results imply cell-specific and pathway-specific effects of GCs, and also prompt future studies to examine GCs' effects on clinical outcomes likely dependent on functional adaptive immune responses.",2020,"A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments.","['patients treated with', 'patients after acute surgical trauma']","['Glucocorticoids (GC', 'placebo or methylprednisolone (MP', 'glucocorticoids']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]",[],,0.170748,"A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments.","[{'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Ganio', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Stanley', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Lindberg-Larsen', 'Affiliation': 'The Lundbeck Foundation Center for Fast-track Hip and Knee replacement, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Einhaus', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Tsai', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Verdonk', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Culos', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Ghaemi', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Rumer', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ina A', 'Initials': 'IA', 'LastName': 'Stelzer', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Dyani', 'Initials': 'D', 'LastName': 'Gaudilliere', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Tsai', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Fallahzadeh', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Choisy', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Section of Surgical Pathophysiology 7621, Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Aghaeepour', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Angst', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Gaudilliere', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA. gbrice@stanford.edu.'}]",Nature communications,['10.1038/s41467-020-17565-y']
243,32721482,Resin Composite Core and Fiber Post Improved the Fracture Parameters of Endodontically Treated Maxillary Premolars with Wedge-shaped Cervical Lesions.,"INTRODUCTION


The aim of this study was to evaluate the fracture resistance and fracture patterns of endodontically treated maxillary premolars with wedge-shaped cervical lesions restored with a resin composite core with or without a fiber post under nonaxial loading.
METHODS


Sixty extracted human maxillary premolars with 2 root canals were randomly allocated into 4 groups (n = 15). Forty-five teeth were prepared with a wedge-shaped lesion at the buccal cervical area and root canal treatment. There were 3 restoration groups: no restoration, restoration with a resin composite core, and restoration with a resin composite core and a fiber post. Intact teeth served as the control group. All teeth were subjected to thermocycling and cyclic loading. A 45° compressive load was applied to the palatal plane of the buccal cusp until tooth fracture. The fracture resistance and facture patterns were analyzed using 1-way analysis of variance and the chi-square test (α = 0.05), respectively.
RESULTS


The no restoration group demonstrated the lowest fracture resistance and was significantly different from the other groups (P < .001). The intact teeth presented the highest fracture resistance, which was not significantly different from the restoration with a resin composite core and a fiber post group (P > .05). The failure patterns were significantly different between groups (P < .001). Most intact teeth fractured coronally to the cementoenamel junction level, whereas most teeth in the other groups fractured at the gingival margin of the cervical lesion.
CONCLUSIONS


Endodontically treated maxillary premolars with wedge-shaped cervical lesions restored with fiber posts and a resin composite cores had a fracture resistance equivalent to intact teeth. However, their fracture patterns were not improved by the fiber post and a resin composite core.",2020,The EB group demonstrated the lowest fracture resistance and was significantly different from other groups (P<0.001).,"['Endodontically-treated Maxillary Premolars with Wedge-shaped Cervical lesions', 'Sixty extracted human maxillary premolars with two root canals', 'Forty five teeth were prepared a wedge-shaped lesion at the buccal cervical area and root canal treatment', 'endodontically-treated maxillary premolars with wedge-shaped cervical lesions restored with resin composite core with/without a fiber post under non-axial loading']",[],"['lowest fracture resistance', 'no restoration (EB), restoration with resin composite core (EBC), and restoration with resin composite core and a fiber post (EBP', 'highest fracture resistance', 'fracture resistance and fracture patterns', 'fracture resistance and facture patterns', 'Fracture parameters', 'failure patterns']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0332503', 'cui_str': 'Wedge shape'}, {'cui': 'C0235656', 'cui_str': 'Lesion of cervix'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0000696', 'cui_str': 'A Fibers'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4279935', 'cui_str': 'Axial Loading'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0000696', 'cui_str': 'A Fibers'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",60.0,0.0211447,The EB group demonstrated the lowest fracture resistance and was significantly different from other groups (P<0.001).,"[{'ForeName': 'Pavita', 'Initials': 'P', 'LastName': 'Tangsripongkul', 'Affiliation': 'Department of Operative Dentistry, Faculty of Dentistry, Chulalongkorn University, Pathumwan, Bangkok, Thailand.'}, {'ForeName': 'Thanomsuk', 'Initials': 'T', 'LastName': 'Jearanaiphaisarn', 'Affiliation': 'Department of Operative Dentistry, Faculty of Dentistry, Chulalongkorn University, Pathumwan, Bangkok, Thailand. Electronic address: thanomsuk@hotmail.com.'}]",Journal of endodontics,['10.1016/j.joen.2020.07.018']
244,32737637,Open versus minimally invasive total gastrectomy after neoadjuvant chemotherapy: results of a European randomized trial.,"BACKGROUND


Surgical resection with adequate lymphadenectomy is regarded the only curative option for gastric cancer. Regarding minimally invasive techniques, mainly Asian studies showed comparable oncological and short-term postoperative outcomes. The incidence of gastric cancer is lower in the Western population and patients often present with more advanced stages of disease. Therefore, the reproducibility of these Asian results in the Western population remains to be investigated.
METHODS


A randomized trial was performed in thirteen hospitals in Europe. Patients with an indication for total gastrectomy who received neoadjuvant chemotherapy were eligible for inclusion and randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG). Primary outcome was oncological safety, measured as the number of resected lymph nodes and radicality. Secondary outcomes were postoperative complications, recovery and 1-year survival.
RESULTS


Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. The mean number of resected lymph nodes was 43.4 ± 17.3 in OTG and 41.7 ± 16.1 in MITG (p = 0.612). Forty-eight patients in the OTG group had a R0 resection and 44 patients in the MITG group (p = 0.617). One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701). No significant differences were found regarding postoperative complications and recovery.
CONCLUSION


These findings provide evidence that MITG after neoadjuvant therapy is not inferior regarding oncological quality of resection in comparison to OTG in Western patients with resectable gastric cancer. In addition, no differences in postoperative complications and recovery were seen.",2021,One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701).,"['Between January 2015 and June 2018, 96 patients were included in this trial', 'thirteen hospitals in Europe', 'Patients with an indication for total gastrectomy who received', 'Western patients with resectable gastric cancer', 'Forty-nine patients']","['open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG', 'OTG', 'Open versus minimally invasive total gastrectomy after neoadjuvant chemotherapy', 'neoadjuvant chemotherapy']","['oncological safety, measured as the number of resected lymph nodes and radicality', 'mean number of resected lymph nodes', 'One-year survival', 'gastric cancer', 'postoperative complications, recovery and 1-year survival', 'postoperative complications and recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439234', 'cui_str': 'year'}]",49.0,0.107117,One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701).,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'van der Wielen', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands. ni.vanderwielen@amsterdamumc.nl.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Straatman', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Daams', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Rosati', 'Affiliation': 'Department of Surgery, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Parise', 'Affiliation': 'Department of Surgery, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'Department of Visceral-, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Reissfelder', 'Affiliation': 'Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Ismael', 'Initials': 'I', 'LastName': 'Diez Del Val', 'Affiliation': 'Department of Surgery, Hospital Universitario de Basurto, Bilbao, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Loureiro', 'Affiliation': 'Department of Surgery, Hospital Universitario de Basurto, Bilbao, Spain.'}, {'ForeName': 'Purificación', 'Initials': 'P', 'LastName': 'Parada-González', 'Affiliation': 'Department of Surgery, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pintos-Martínez', 'Affiliation': 'Department of Surgery, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Mateo Vallejo', 'Affiliation': 'Department of Surgery, Hospital de Jerez, Jerez de la Frontera, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Medina Achirica', 'Affiliation': 'Department of Surgery, Hospital de Jerez, Jerez de la Frontera, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Sánchez-Pernaute', 'Affiliation': 'Department of Surgery, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Ruano Campos', 'Affiliation': 'Department of Surgery, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bonavina', 'Affiliation': 'Department of Surgery, IRCCS Policlinico San Donato, Milan, Italy.'}, {'ForeName': 'Emanuele L G', 'Initials': 'ELG', 'LastName': 'Asti', 'Affiliation': 'Department of Surgery, IRCCS Policlinico San Donato, Milan, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Alonso Poza', 'Affiliation': 'Department of Surgery, Hospital del Sureste, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gilsanz', 'Affiliation': 'Department of Surgery, Hospital del Sureste, Madrid, Spain.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Surgery, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lindblad', 'Affiliation': 'Department of Surgery, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Gisbertz', 'Affiliation': 'Department of Gastro-intestinal Surgery, Amsterdam University Medical Center Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Gastro-intestinal Surgery, Amsterdam University Medical Center Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Uberto', 'Initials': 'U', 'LastName': 'Fumagalli Romario', 'Affiliation': 'Department of Surgery, ASST Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'De Pascale', 'Affiliation': 'Department of Surgery, ASST Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Khurshid', 'Initials': 'K', 'LastName': 'Akhtar', 'Affiliation': 'Department of Surgery, Salford Royal NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jaap Bonjer', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Cuesta', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'van der Peet', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01109-w']
245,32739569,Randomized Controlled Trial of Advance Notification Phone Calls vs Text Messages Prior to Mailed Fecal Test Outreach.,"BACKGROUND & AIMS


Mailing fecal immunochemical test (FITs) to individuals who are due for screening (mailed FIT outreach) increases colorectal cancer (CRC) screening. Little is known about how phone-based advance notifications (primers) affect the effectiveness of mailed FIT outreach programs.
METHODS


We performed a prospective study of patients at a large urban health center, 50-75 years old and due for screening, with no record of a prior FIT. Participants were randomly assigned to groups that received a live phone call primer (n = 1203) or a text message primer (n = 1622), from June through December 2018. The participants were then mailed a FIT kit, followed by 2 automated calls, and live reminder calls delivered by the care team. The main outcome was completion of FIT within 3 months of assignment to the live phone call or text message group.
RESULTS


Participants had a FIT completion rate of 16.8%, a mean age of 58 years, and 80% were Latino. In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%). Between-group differences increased to 7.3% points (95% CI, 3.6%-11.0%) in the per-protocol analysis of 2144 participants reached by the text message (1320/1622, 81%), live call (438/1203, 36%), or voice message (386/1203, 32%). This rate increased to 14.9% points (95% CI; 9.6%-20.1%) in the per-protocol analysis of 1758 participants reached by the text message or reached by the live call.
CONCLUSIONS


In a randomized trial, advance notification live phone calls outperformed text messages in prompting health center patients who had not previously completed a FIT to complete a mailed FIT. Clinicaltrials.gov no: NCT03167125.",2021,"In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%).","['individuals who are due for screening (mailed FIT outreach) increases colorectal cancer (CRC) screening', 'patients at a large urban health center, 50-75 years old and due for screening, with no record of a prior FIT', 'reminding health center patients who had not previously completed a FIT to complete a mailed FIT']",['live phone call primer (n = 1203) or a text message primer'],"['FIT completion rate', 'FIT completion rates', 'voice message']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041933', 'cui_str': 'Urban Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332127', 'cui_str': 'No record of'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0557033', 'cui_str': 'Reminding'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0206415', 'cui_str': 'Oligonucleotide Primers'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]",2825.0,0.236928,"In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%).","[{'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon. Electronic address: gloria.d.coronado@kpchr.org.'}, {'ForeName': 'Denis B', 'Initials': 'DB', 'LastName': 'Nyongesa', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Petrik', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Jamie H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Escaron', 'Affiliation': 'AltaMed Health Services, Los Angeles, California.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Younger', 'Affiliation': 'AltaMed Health Services, Los Angeles, California.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Harbison', 'Affiliation': 'AltaMed Health Services, Los Angeles, California.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.07.053']
246,32720695,Effects of Pregnancy and Isoniazid Preventive Therapy on Mycobacterium tuberculosis Interferon Gamma Response Assays in Women With HIV.,"BACKGROUND


Pregnancy is accompanied by immune suppression. We hypothesized that Mycobacterium tuberculosis-specific inflammatory responses used to identify latent tuberculosis infection (LTBI) lose positivity during pregnancy. We also hypothesized that isoniazid preventive therapy (IPT) may revert LTBI diagnoses because of its sterilizing activity.
METHODS


944 women with human immunodeficiency virus infection (HIV) participating in a randomized, double-blind, placebo-controlled study comparing 28 weeks of IPT antepartum versus postpartum, were tested by QuantiFERON-gold-in-tube (QGIT) antepartum and by QGIT and tuberculin skin test (TST) at delivery and postpartum. Serial QGIT positivity was assessed by logistic regression using generalized estimating equations.
RESULTS


From entry to delivery, 68 (24%) of 284 QGIT-positive women reverted to QGIT-negative or indeterminate. Of these, 42 (62%) recovered QGIT positivity postpartum. The loss of QGIT positivity during pregnancy was explained by decreased interferon gamma (IFNγ) production in response to TB antigen and/or mitogen. At delivery, LTBI was identified by QGIT in 205 women and by TST in 113 women. Corresponding numbers postpartum were 229 and 122 women. QGIT and TST kappa agreement coefficients were 0.4 and 0.5, respectively. Among QGIT-positive women antepartum or at delivery, 34 (12%) reverted to QGIT-negative after IPT. There were no differences between women who initiated IPT antepartum or postpartum.
CONCLUSIONS


Decreased IFNγ responses in pregnancy reduced QGIT positivity, suggesting that this test cannot reliably rule out LTBI during pregnancy. TST was less affected by pregnancy, but had lower positivity compared to QGIT at all time points. IPT was associated with loss of QGIT positivity, the potential clinical consequences of which need to be investigated.",2021,"TST was less affected by pregnancy, but had lower positivity compared to QGIT at all time points.","['Women with HIV', 'Corresponding numbers postpartum were 229 and 122 women', '944 women with HIV participating']","['IPT', 'Pregnancy and Isoniazid Preventive Therapy', 'IPT antepartum versus postpartum, were tested by QuantiFERON-gold-in-tube (QGIT) antepartum and by QGIT and tuberculin skin test (TST', 'isoniazid preventive therapy (IPT', 'placebo']","['Serial QGIT positivity', 'QGIT and TST kappa agreement coefficients', 'IPT antepartum or postpartum', 'QGIT positivity postpartum', 'TST', 'loss of QGIT positivity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0456336', 'cui_str': 'Antepartum'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0456336', 'cui_str': 'Antepartum'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",944.0,0.21607,"TST was less affected by pregnancy, but had lower positivity compared to QGIT at all time points.","[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weinberg', 'Affiliation': 'Department of Pediatrics, Medicine and Pathology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Aaron', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Montepiedra', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Sterling', 'Affiliation': 'Vanderbilt Tuberculosis Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Browning', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Blandina', 'Initials': 'B', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical Centre (KCMC) Moshi, Tanzania.'}, {'ForeName': 'Tichaona', 'Initials': 'T', 'LastName': 'Vhembo', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre (UZCHS-CTRC), Harare, Zimbabwe.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Naik', 'Affiliation': 'Department of Obstetrics and Gynaecology, BJGMC, Pune, India.'}, {'ForeName': 'Enid', 'Initials': 'E', 'LastName': 'Kabugho', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Gaerolwe', 'Initials': 'G', 'LastName': 'Masheto', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana, and Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Pahwa', 'Affiliation': 'Department of Microbiology and Immunology, University of Miami School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Jyoti S', 'Initials': 'JS', 'LastName': 'Mathad', 'Affiliation': 'Department of Medicine, Center for Global Health, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Sylvia M', 'Initials': 'SM', 'LastName': 'LaCourse', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'McCarthy', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bradford', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'FAM-CRU CRS, Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Costello', 'Affiliation': 'University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Zimmer', 'Affiliation': 'Frontier Science Foundation, Amherst, New York, USA.'}, {'ForeName': 'Marie F', 'Initials': 'MF', 'LastName': 'Pierre', 'Affiliation': 'Les Centres GHESKIO, Port-au-Prince, Haïti.'}, {'ForeName': 'Kamunkhwala', 'Initials': 'K', 'LastName': 'Gausi', 'Affiliation': 'Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Denti', 'Affiliation': 'Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Haas', 'Affiliation': 'Vanderbilt Tuberculosis Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Departments of Medicine and International Health, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1083']
247,32739224,Randomized controlled trial of the foot reflexology on pain and anxiety severity during dressing change in burn patients.,"BACKGROUND


One of the most important problems in burn patients was pain, especially in dressing changes. This pain can lead to anxiety in the patient. The aim of this study was to determine the effect of foot reflexology on pain and anxiety severity in burn patients.
METHODS


This study was a randomized controlled trial, in which 66 patients with burn injuries referred to Vali-e-asr Hospital, Arak, Iran participated. After obtaining written consent, patients were enrolled to study according to inclusion criteria and then, divided into intervention (n = 33) and control (n = 33) groups using simple random allocation. In the intervention group, in addition to standard care, reflexology was performed for one week on Saturday, Monday and Wednesday (three times in a week). The intervention was done one hour before dressing change in a separate room for 30 min. The control group received only standard care during this time (both intervention and control groups were the same in the type of treatment, and reflexology was considered as an extra care in the intervention group). Severity of pain and anxiety in both groups was measured using visual analog scale twice a day (5-10 min before dressing change and 5-10 min after dressing change) for six days. SPSS software ver. 15 was used for statistical analysis. Mean and standard deviation were used for quantitative variables and qualitative variables were reported as frequency and percentage. Data were analyzed using Chi‑square, Mann-Whitney, Fisher's exact tests, and paired t-test. The Kolmogorov-Smirnov test was used to check the normality of data.
RESULTS


The results showed no significant difference in severity of pain (p = 0.25) and anxiety (p = 0.37) between the two groups on the first day, before the intervention. In the following days, the results showed no significant difference between the two groups in the second and third treatments after intervention . However, the mean pain scores showed a significant difference between the two groups in the forth (p = 0.005), fifth (p = 0.001), and sixth (p = 0.001) days after intervention. Anxiety scores also showed a significant difference between the two groups on the fourth (p = 0.01), fifth (p = 0.001), and sixth (p = 0.001) days.
CONCLUSIONS


Our results showed foot reflexology is an appropriate and safe intervention for management of pain and anxiety of burn patients. Therefore, it can be used as a complementary method alongside other methods.",2021,"In the following days, the results showed no significant difference between the two groups in the second and third treatments after intervention .","['66 patients with burn injuries referred to Vali-e-asr Hospital, Arak, Iran participated', 'burn patients']",['foot reflexology'],"['anxiety', 'severity of pain', 'Anxiety scores', 'mean pain scores', 'Severity of pain and anxiety', 'Mean and standard deviation', 'pain and anxiety severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",66.0,0.044738,"In the following days, the results showed no significant difference between the two groups in the second and third treatments after intervention .","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabady', 'Affiliation': 'Clinical Research Development Center of Amiralmomenin Hospital, Arak University of Medical Sciences, Arak, Iran. Electronic address: davodabadi.f@arakmu.ac.ir.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Naseri-Salahshour', 'Affiliation': 'School of Nursing and Midwifery, Saveh University of Medical Sciences, Saveh, Iran. Electronic address: vahidnaseri1994@yahoo.com.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Sajadi', 'Affiliation': 'Clinical Research Development Center of Amiralmomenin Hospital, Arak University of Medical Sciences, Arak, Iran. Electronic address: m.sajadi@arakmu.ac.ir.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Mohtarami', 'Affiliation': 'School of Medicine, Arak University of Medical Sciences, Arak, Iran. Electronic address: doctor_a_mohtarami@yahoo.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rafiei', 'Affiliation': 'School of Health, Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: f.rafiei87@yahoo.com.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.06.035']
248,32761174,"Effects of a Water, Sanitation, and Hygiene Mobile Health Program on Diarrhea and Child Growth in Bangladesh: A Cluster-randomized Controlled Trial of the Cholera Hospital-based Intervention for 7 Days (CHoBI7) Mobile Health Program.","BACKGROUND


The Cholera Hospital-Based Intervention for 7 Days (CHoBI7) mobile health (mHealth) program was a cluster-randomized controlled trial of diarrhea patient households conducted in Dhaka, Bangladesh.
METHODS


Patients were block-randomized to 3 arms: standard message on oral rehydration solution use; health facility delivery of CHoBI7 plus mHealth (no home visits); and health facility delivery of CHoBI7 plus 2 home visits and mHealth. The primary outcome was reported diarrhea in the past 2 weeks collected monthly for 12 months. The secondary outcomes were stunting, underweight, and wasting at a 12-month follow-up. Analysis was intention-to-treat.
RESULTS


Between 4 December 2016 and 26 April 2018, 2626 participants in 769 households were randomly allocated to 3 arms: 849 participants to the standard message arm, 886 to mHealth with no home visits arm, and 891 to the mHealth with 2 home visits. Children <5 years had significantly lower 12-month diarrhea prevalence in both the mHealth with 2 home visits arm (prevalence ratio [PR]: 0.73 [95% confidence interval {CI}, .61-.87]) and the mHealth with no home visits arm (PR: 0.82 [95% CI, .69-.97]). Children <2 years were significantly less likely to be stunted in both the mHealth with 2 home visits arm (33% vs 45%; odds ratio [OR]: 0.55 [95% CI, .31-.97]) and the mHealth with no home visits arm (32% vs 45%; OR: 0.54 [95% CI, .31-.96]) compared with children in the standard message arm.
CONCLUSIONS


The CHoBI7 mHealth program lowered pediatric diarrhea and stunting among diarrhea patient households.
CLINICAL TRIALS REGISTRATION


NCT04008134.",2021,"Children under five years had significantly lower 12-month diarrhea prevalence in both the mHealth with two home visits arm (Prevalence Ratio(PR): 0.73 (95% Confidence Interval(CI): 0.61, 0.87)) and the mHealth with no home visits arm (PR: 0.82 (95% CI: 0.69, 0.97)).","['Patients were block-randomized to three arms', 'Between December 4, 2016 and April 26, 2018', 'Diarrhea and Child Growth in Bangladesh', 'diarrhea patient households conducted in Dhaka, Bangladesh', '2626 participants in 769 households were randomly allocated to three arms: 849 participants to standard message, 886 to mHealth with no home visits, and 891 to mHealth with two home visits']","['Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) mobile health (mHealth) program', 'Water, Sanitation and Hygiene Mobile Health Program', 'standard recommendation on oral rehydration solution use; health facility delivery of CHoBI7 plus mHealth (no home visits); and health facility delivery of CHoBI7 plus two home visits and mHealth']","['pediatric diarrhea and stunting', 'diarrhea', '12-month diarrhea prevalence', 'stunting, underweight, and wasting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0078516', 'cui_str': 'World Health Organization oral rehydration solution'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}]",769.0,0.179197,"Children under five years had significantly lower 12-month diarrhea prevalence in both the mHealth with two home visits arm (Prevalence Ratio(PR): 0.73 (95% Confidence Interval(CI): 0.61, 0.87)) and the mHealth with no home visits arm (PR: 0.82 (95% CI: 0.69, 0.97)).","[{'ForeName': 'Christine Marie', 'Initials': 'CM', 'LastName': 'George', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'M Tasdik', 'Initials': 'MT', 'LastName': 'Hasan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Hasan', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Mahamud-Ur', 'Initials': 'MU', 'LastName': 'Rashid', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Aminul', 'Initials': 'A', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Zillur', 'Initials': 'Z', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Raisa', 'Initials': 'R', 'LastName': 'Rafique', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Md Sazzadul', 'Initials': 'MS', 'LastName': 'Islam Bhuyian', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Saxton', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Labrique', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Alland', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Indrajeet', 'Initials': 'I', 'LastName': 'Barman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Fatema Tuz', 'Initials': 'FT', 'LastName': 'Jubyda', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Afroze', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Marzia', 'Initials': 'M', 'LastName': 'Sultana', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Fatema-Tuz', 'Initials': 'FT', 'LastName': 'Johura', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Md Abul Hasem', 'Initials': 'MAH', 'LastName': 'Khan', 'Affiliation': 'Bangladesh Ministry of Health and Family Welfare, Dhaka, Bangladesh.'}, {'ForeName': 'Sanya', 'Initials': 'S', 'LastName': 'Tahmina', 'Affiliation': 'Bangladesh Ministry of Health and Family Welfare, Dhaka, Bangladesh.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Munmun', 'Affiliation': 'Bangladesh Ministry of Health and Family Welfare, Dhaka, Bangladesh.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa754']
249,32746774,"Effects of Two Weekly Servings of Cod for 16 Weeks in Pregnancy on Maternal Iodine Status and Infant Neurodevelopment: Mommy's Food, a Randomized-Controlled Trial.","Background:  Mild-to-moderate iodine deficiency is still present in many countries, particularly in pregnant women. Observational studies suggest that mild-to-moderate iodine deficiency during pregnancy may be associated with impaired thyroid function and child neurodevelopment. Randomized-controlled food trials to increase iodine status are scarce. We assessed the impact of an increased intake of cod during pregnancy on maternal iodine status and infant neurodevelopment.  Methods:  In this randomized-controlled trial, pregnant women in Bergen, Norway, recruited through Haukeland University Hospital, were randomly assigned (1:1) to an intervention of 200 g of cod twice a week for 16 weeks (gestational week 20-36) or to continue with their standard diet (control group). Randomization was done by lottery. Primary outcome was urinary iodine concentration (UIC) (spot samples from six consecutive days) measured postintervention. Secondary outcome was infant neurodevelopment assessed by the cognitive, language, and motor scales of the  Bayley Scales of Infant and Toddler Developmental  third edition (Bayley-III) at 11 months of age. In addition, maternal thyroid function was measured (thyrotropin [TSH], free triiodothyronine [fT3], free thyroxine [fT4]) at baseline and postintervention.  Results:  Between January 2016 until February 2017, 137 women were recruited. Postintervention UIC was higher in the intervention group ( n  = 61) [median (interquartile range, IQR) 98 (64-145) μg/L], compared with control ( n  = 61) [median (IQR) 73 (52-120) μg/L] ( p  = 0.028), also after adjusting for baseline UIC ( p  = 0.048). Infants of mothers in the intervention group had a lower cognitive composite score on the Bayley-III compared with the control group ( p  = 0.045). There were no group differences in the Bayley III language- or motor composite scores. Maternal thyroid hormones (TSH, fT3, fT4) did not differ between the groups postintervention.  Conclusions:  Increased cod intake during pregnancy improved the iodine status in women with mild-to-moderate iodine deficiency, however, did not affect thyroid function. The negative effect on cognition should be followed up to assess whether this is a stable effect over time. More studies are warranted to enable good health advice on iodine nutrition in pregnancy. ClinicalTrials.gov NCT02610959. Registered November 20, 2015.",2021,"Infants of mothers in the intervention group had a lower cognitive composite score on the Bayley-III compared to the control group, (p= 0.045).","['Results Between Jan 2016 until Feb 2017', 'pregnant women in Bergen, Norway, recruited through Haukeland University Hospital', '137 women were recruited', 'pregnant women']",[],"['lower cognitive composite score', 'urinary iodine concentration (UIC) (spot samples', 'Maternal thyroid hormones (TSH, fT3, fT4', 'infant neurodevelopment assessed by the cognitive, language and motor scales of the Bayley Scales of Infant and Toddler Developmental 3rd edition (Bayley-III', 'Bayley III language- or motor composite scores', 'maternal iodine status and infant neurodevelopment', 'maternal thyroid function', 'maternal iodine status, and infant neurodevelopment']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",137.0,0.201058,"Infants of mothers in the intervention group had a lower cognitive composite score on the Bayley-III compared to the control group, (p= 0.045).","[{'ForeName': 'Maria Wik', 'Initials': 'MW', 'LastName': 'Markhus', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hysing', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Lisa Kolden', 'Initials': 'LK', 'LastName': 'Midtbø', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Ive', 'Initials': 'I', 'LastName': 'Nerhus', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Synnøve', 'Initials': 'S', 'LastName': 'Næss', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Aakre', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Dahl', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Kjellevold', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2020.0115']
250,32763435,Maxillary Lateral Incisor Injection Pain Using the Dentapen Electronic Syringe.,"INTRODUCTION


When patients express fear and anxiety about dentistry, 1 main source involves the administration of local anesthetic. The Dentapen (Septodont, Lancaster, PA) is a computer-controlled local anesthetic device that regulates the rate of anesthetic deposition to reduce pain associated with dental injections. The purpose of this study was to evaluate differences in perceived pain during the administration of local anesthesia of the maxillary lateral incisors using the ramp-up and continuous injection modes of the Dentapen.
METHODS


This study used a randomized, controlled, double-blind, crossover, experimental design. The investigators randomly assigned the order of the teeth (#7 or #10) and the 2 delivery modes (continuous or ramp-up). Participants completed a Corah dental anxiety scale at each visit and were injected on 2 separate visits at least 2 weeks apart. After each injection, participants rated their perceived pain using a Heft-Parker visual analog scale at needle insertion, needle placement, and solution deposition. Repeated measures analysis of variance was used to determine differences in perceived pain between the 2 modes.
RESULTS


The data from 116 participants were analyzed. The perceived pain at deposition with the ramp-up mode (mean = 51.98, standard deviation = 30.04) was less than the continuous mode (mean = 59.98, standard deviation = 36.28) although not statistically significant (F 1230  = 2.569, P > .05). Clinically, the perceived pain with the ramp-up mode was in the mild range (<54 mm), whereas the mean perceived pain with the continuous mode was in the moderate/severe range (>54 mm).
CONCLUSIONS


Further research should evaluate whether the ramp-up mode could be used to reduce the pain perceived with other dental injections.",2020,"The perceived pain at deposition with the ramp-up mode (M=51.98, sd=30.04) was less than the continuous mode (M=59.98, sd=36.28), although not statistically significant (F(1,230)=2.569, p>.05).",['116 participants were analyzed'],['Dentapen electronic syringe'],"[""Corah's dental anxiety scale"", 'perceived pain at deposition', 'Maxillary lateral incisor injection pain']","[{'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}]","[{'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}]",116.0,0.101603,"The perceived pain at deposition with the ramp-up mode (M=51.98, sd=30.04) was less than the continuous mode (M=59.98, sd=36.28), although not statistically significant (F(1,230)=2.569, p>.05).","[{'ForeName': 'Brian B', 'Initials': 'BB', 'LastName': 'Partido', 'Affiliation': 'Division of Dental Hygiene, The Ohio State University College of Dentistry, Columbus, Ohio. Electronic address: brian.partido@seattlecolleges.edu.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Nusstein', 'Affiliation': 'Division of Endodontics, The Ohio State University College of Dentistry, Columbus, Ohio.'}, {'ForeName': 'Kyerston', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Division of Dental Hygiene, The Ohio State University College of Dentistry, Columbus, Ohio.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Lally', 'Affiliation': 'Division of Dental Hygiene, The Ohio State University College of Dentistry, Columbus, Ohio.'}]",Journal of endodontics,['10.1016/j.joen.2020.07.029']
251,32767766,An Open-Label Study Evaluating the Pharmacokinetics and Safety of Diclofenac Potassium for Oral Solution for the Acute Treatment of MWA or MWoA in Pediatric Participants.,"OBJECTIVE


To evaluate the pharmacokinetics, safety, and tolerability of a single 50-mg oral dose of diclofenac potassium for oral solution (OS) in a pediatric cohort with a diagnosis of episodic migraine; the 3-month safety trial following an outpatient dosing period was also evaluated.
BACKGROUND


Children and adolescents often experience migraine pain that is poorly controlled, which may affect their emotional and psychological well-being. Diclofenac potassium for OS is approved for the treatment of migraine with aura (MWA) or migraine without aura (MWoA) in adults 18 years of age or older. It is formulated in a soluble buffered powder that provides more rapid absorption than the tablet formulations of diclofenac potassium. In a randomized, double-blind, crossover trial, more adult patients were pain-free at 2 hours post-dose following treatment with diclofenac potassium for OS than those who received the diclofenac tablet formulation or placebo.
METHODS


This was a Phase 4 open-label study that took place at 2 US sites. Participants 12-17 years of age with a diagnosis of episodic MWA or MWoA for ≥3 months and ≤14 headaches per month were enrolled in the study. Participants received one 50-mg dose of diclofenac potassium for OS under fasted conditions on day 1. Blood samples were collected for PK analysis within 15 minutes pre-dose and at 5, 10, 15, 20, 30, 40, and 60 minutes post-dose, and at 2, 4, and 6 hours post-dose. Safety evaluations were performed after the initial dose and at the end of study on day 90; adverse events were monitored throughout the study. After completing the PK assessments, participants were given a 3-month supply (27 packets) of diclofenac potassium for OS (50-mg doses) for their migraine attacks. Participants were advised to take diclofenac potassium for OS at the onset of a migraine. They were told to take no more than 2 doses daily and not to use it more than 3 days/week.
RESULTS


Twenty-five participants completed the study; 84% were females and 96% were white or Caucasian, with a mean age of 15.5 years and a mean weight of 63.1 kg. Diclofenac was rapidly absorbed with a median time to maximum concentration of 15 minutes and a mean peak plasma concentration of 1412 (±846.2) ng/mL. Diclofenac had a half-life of 66.8 (±9.2) minutes. The mean area under the concentration-time curve from zero to the last measurable time point was 82,920.0 (±25,327.6) minutes × ng/mL, and the mean area under the concentration-time curve from time zero to infinity was 84,388.8 (±25,993.6) minutes × ng/mL. Participants took the study drug an average of 10 times over 79 days, with an overall total drug exposure of 506 mg. No deaths or discontinuations due to an AE were reported during the study. The most frequently reported treatment emergent adverse events were arthralgia and motion sickness, each of which occurred in 2 (8%) of the participants.
CONCLUSIONS


Diclofenac potassium for OS exhibited a favorable pharmacokinetic and safety profile in 12- to 17-year-old patients with a diagnosis of episodic MWA or MWoA.",2020,Diclofenac was rapidly absorbed with a median time to maximum concentration of 15 minutes and a mean peak plasma concentration of 1412 (±846.2),"['Twenty-five participants completed the study; 84% were females and 96% were white or Caucasian, with a mean age of 15.5\xa0years and a mean weight of 63.1\xa0kg', '12- to 17-year-old patients with a diagnosis of episodic MWA or MWoA', 'Pediatric Participants', 'migraine with aura (MWA) or migraine without aura (MWoA) in adults 18\xa0years of age or older', 'pediatric cohort with a diagnosis of episodic migraine', 'Participants 12-17\xa0years of age with a diagnosis of episodic MWA or MWoA for ≥3\xa0months and ≤14 headaches per month were enrolled in the study']","['diclofenac potassium', 'Diclofenac Potassium', 'diclofenac potassium for oral solution (OS', 'diclofenac potassium for OS', 'Diclofenac', 'diclofenac tablet formulation or placebo', 'Diclofenac potassium']","['pain-free', 'pharmacokinetic and safety profile', 'mean area under the concentration-time curve', 'adverse events', 'pharmacokinetics, safety, and tolerability']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0154723', 'cui_str': 'Migraine with aura'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]","[{'cui': 'C0282131', 'cui_str': 'Diclofenac potassium'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",84.0,0.0704587,Diclofenac was rapidly absorbed with a median time to maximum concentration of 15 minutes and a mean peak plasma concentration of 1412 (±846.2),"[{'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'McVige', 'Affiliation': 'Headache Clinic, Dent Neurologic Institute, Amherst, NY, USA.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Hogan', 'Affiliation': 'Headache Clinic, Dent Neurologic Institute, Amherst, NY, USA.'}, {'ForeName': 'Clayton M', 'Initials': 'CM', 'LastName': 'Shanahan', 'Affiliation': 'Headache Clinic, Dent Neurologic Institute, Amherst, NY, USA.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Amend', 'Affiliation': 'gRED Clinical Operations, Depomed, Inc, Newark, CA, USA.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'Ferger', 'Affiliation': 'Department of Administration, Dent Neurologic Institute, Amherst, NY, USA.'}]",Headache,['10.1111/head.13922']
252,32785709,Safety and Efficacy of Rifampin or Isoniazid Among People With Mycobacterium tuberculosis Infection and Living With Human Immunodeficiency Virus or Other Health Conditions: Post Hoc Analysis of 2 Randomized Trials.,"BACKGROUND


The safety and efficacy of rifampin among people living with human immunodeficiency virus (PLHIV) or other health conditions is uncertain. We assessed completion, safety, and efficacy of 4 months of rifampin vs 9 months of isoniazid among PLHIV or other health conditions.
METHODS


We conducted post hoc analysis of 2 randomized trials that included 6859 adult participants with Mycobacterium tuberculosis infection. Participants were randomized 1:1 to 10 mg/kg/d rifampin or 5 mg/kg/d isoniazid. We report completion, drug-related adverse events (AE), and active tuberculosis incidence among people living with HIV; with renal failure or receiving immunosuppressants; using drugs or with hepatitis; with diabetes mellitus; consuming >1 alcoholic drink per week or current/former smokers; and with no health condition.
RESULTS


Overall, 270 (3.9%) people were living with HIV (135 receiving antiretroviral therapy), 2012 (29.3%) had another health condition, and 4577 (66.8%) had no condition. Rifampin was more often or similarly completed to isoniazid in all populations. AEs were less common with rifampin than isoniazid among PLHIV (risk difference, -2.1%; 95% confidence interval [CI], -5.9 to 1.6). This was consistent for others except people with renal failure or on immunosuppressants (2.1%; 95% CI, -7.2 to 11.3). Tuberculosis incidence was similar among people receiving rifampin or isoniazid. Among participants receiving rifampin living with HIV, incidence was comparable to those with no health condition (rate difference, 4.1 per 1000 person-years; 95% CI, -6.4 to 14.7).
CONCLUSIONS


Rifampin appears to be safe and as effective as isoniazid across many populations with health conditions, including HIV.
CLINICAL TRIALS REGISTRATION


NCT00170209; NCT00931736.",2021,"Drug-related adverse events were less common with rifampin than isoniazid among people living with HIV (risk difference: -2.1%, 95%CI -5.9 to 1.6).","['people 1) living with HIV; 2) with renal failure or receiving immunosuppressants; 3) using drugs or with hepatitis; 4) with diabetes mellitus', '6859 adult participants with Mycobacterium tuberculosis infection', 'People with Mycobacterium tuberculosis Infection and Living with HIV or Other Health Conditions', 'people living with HIV or other health conditions']","['Rifampin', 'rifampin or isoniazid', 'alcoholic drink per week or current/former smokers; 6) with no health condition', 'isoniazid', 'Rifampin or Isoniazid', 'rifampin or 5 mg/kg/d isoniazid', 'rifampin']","['Tuberculosis incidence', 'Safety and Efficacy', 'completion, safety, and efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0019158', 'cui_str': 'Inflammatory disease of liver'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",6859.0,0.484171,"Drug-related adverse events were less common with rifampin than isoniazid among people living with HIV (risk difference: -2.1%, 95%CI -5.9 to 1.6).","[{'ForeName': 'Jonathon R', 'Initials': 'JR', 'LastName': 'Campbell', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Hamdan', 'Initials': 'H', 'LastName': 'Al-Jahdali', 'Affiliation': 'Department of Medicine, King Saud University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Bah', 'Affiliation': 'Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Belo', 'Affiliation': 'Department of Medicine, Fundação Técnico Educacional Souza Marques, Rio de Janeiro, Brazil.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Cook', 'Affiliation': 'Provincial Tuberculosis Services, British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Long', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Schwartzman', 'Affiliation': 'McGill International TB Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Anete', 'Initials': 'A', 'LastName': 'Trajman', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1169']
253,32777142,l-carnitine supplementation vs cycle ergometer exercise for physical activity and muscle status in hemodialysis patients: A randomized clinical trial.,"Serum carnitine is decreased in hemodialysis patients, which induces muscle atrophy. Thus, we examined the different effects of l-carnitine and exercise on exercise activity and muscle status in hemodialysis patients. Twenty patients were divided into l-carnitine and cycle ergometer groups and were followed for 3 months. Muscle and fat mass, physical activities, and muscle status were evaluated by an impedance, physical function test, and magnetic resonance imaging, respectively. The l-carnitine significantly increased muscle mass (P = .023) and thigh circumference (P = .027), decreased fat mass (P = .007), and shortened chair stand-up time (P = .002) and 10-m walk test (P = .037). The fat fraction was improved by the l-carnitine (P = .047). Compared with the exercise group, l-carnitine improved the changes in 10-m walk test (P = .026), chair stand-up time (P = .014), and thigh circumference (P = .022). Baseline fibroblast growth factor-21 and myostatin levels predicted the l-carnitine-associated changes in exercise activities. l-carnitine, rather than exercise, improved physical activity and muscle status in hemodialysis patients.",2021,"The L-carnitine significantly increased muscle mass (p = .023) and thigh circumference (p = .027), decreased fat mass (p = .007), and shortened chair stand-up time (p = .002) and 10-meter walking time (p = .037).","['hemodialysis patients', 'Twenty patients were divided into']","['L-carnitine and cycle ergometer', 'L-carnitine supplementation versus cycle ergometer exercise', 'L-carnitine and exercise']","['physical activity and muscle status', 'thigh circumference', 'chair stand-up time', 'exercise activity and muscle status', 'muscle mass', 'fat fraction', '10-meter walk test', 'Muscle and fat mass, physical activities, and muscle status', 'fat mass', 'Serum carnitine', 'Baseline fibroblast growth factor-21 and myostatin levels', '10-meter walking time', 'shortened chair stand-up time']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0444796', 'cui_str': 'Standing up'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0201937', 'cui_str': 'Carnitine measurement, serum'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}]",20.0,0.0132059,"The L-carnitine significantly increased muscle mass (p = .023) and thigh circumference (p = .027), decreased fat mass (p = .007), and shortened chair stand-up time (p = .002) and 10-meter walking time (p = .037).","[{'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Yano', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kaida', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Ryuki', 'Initials': 'R', 'LastName': 'Hashida', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Tatsuyuki', 'Initials': 'T', 'LastName': 'Tonan', 'Affiliation': 'Department of Radiology, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Nagata', 'Affiliation': 'Department of Radiology, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Hazama', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Nakayama', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Sakuya', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Otome', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Shibata', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Tashiro', 'Affiliation': 'Research Institute of Medical Mass Spectrometry, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Tatsuyuki', 'Initials': 'T', 'LastName': 'Kakuma', 'Affiliation': 'Biostatistics Center, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Hiroo', 'Initials': 'H', 'LastName': 'Matsuse', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Fukami', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13576']
254,32773581,"The effect of aspirin on preeclampsia, intrauterine growth restriction and preterm delivery among healthy pregnancies with a history of preeclampsia.","BACKGROUND


Due to the significance of preeclampsia (PE) and its adverse outcomes in the health of both mother and newborn, the present study was carried out to investigate the effect of aspirin on preventing the occurrence of PE, intrauterine growth restriction (IUGR), and preterm delivery in women with a previous history of PE.
METHODS


The present clinical trial was conducted on 90 pregnant women with a previous history of PE referred to the Khalij Fars Hospital in Bandar Abbas, Hormozgan Province Iran from April 2017 to August 2018. The subjects of the study were randomly assigned into two groups of intervention and control to receive either 80 mg of aspirin or placebo daily during the pregnancy. Patients' information was obtained and recorded upon entering the study, follow-up visits, and childbirth.
RESULTS


Among participants who entered the clinical trial, 86 patients (95.6%) completed the study. During the pregnancy, systolic blood pressure increased by 8.25 ± 14.83 and 19.06 ± 18.33 mmHg in aspirin and placebo groups, respectively (p = 0.001). Also, the same happened with diastolic blood pressure (6.12 ± 11.46 vs 13.48 ± 13.95 mmHg, p = 0.010). The rate of PE was equal to 27 (62.8%) and 38 (88.4%) in the aspirin and placebo groups, respectively (aOR = 0.23, p = 0.013). In the aspirin group, the rate of IUGR was equal to 27.9% compared with 25.6% of newborns in the control group (aOR = 1.18, p = 0.750). Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p = 0.061).
CONCLUSION


The findings of the present study conducted exclusively on women with previous documented PE revealed that taking aspirin may have a preventive effect on PE in the current pregnancy.",2020,"Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p=0.061).
","['participants who entered the clinical trial, 86 patients (95.6%) completed the study', '90 pregnant women with a previous history of PE referred to the Khalij Fars Hospital in Bandar Abbas, Hormozgan Province Iran from April 2017 to August 2018', 'healthy pregnancies with a history of preeclampsia']","['intervention and control to receive either 80 mg of aspirin or placebo', 'aspirin', 'placebo']","['rate of IUGR', 'preeclampsia, intrauterine growth restriction and preterm delivery', 'rate of PE', 'systolic blood pressure', 'diastolic blood pressure', 'occurrence of PE, Intrauterine Growth Restriction (IUGR), and preterm delivery', 'rate of preterm delivery']","[{'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4076023', 'cui_str': 'History of pre-eclampsia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",90.0,0.0760191,"Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p=0.061).
","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Abdi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Afsane', 'Initials': 'A', 'LastName': 'Rozrokh', 'Affiliation': 'Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Zare', 'Affiliation': 'Epidemiology Department, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000400']
255,32794087,Peer and Non-Peer Co-Facilitation of a Health and Wellness Intervention for Adults with Serious Mental Illness.,"Peer specialists, or individuals with lived experience of mental health conditions who support the mental health recovery of others, often work side-by-side with traditional providers (non-peers) in the delivery of treatment groups. The present study aimed to examine group participant and peer provider experiences with peer and non-peer group co-facilitation. Data from a randomized controlled trial of Living Well, a peer and non-peer co-facilitated intervention for medical illness management for adults with serious mental illness, were utilized. A subset of Living Well participants (n = 16) and all peer facilitators (n = 3) completed qualitative interviews. Transcripts were coded and analyzed using a general inductive approach and thematic analysis. The complementary perspectives of the facilitators, teamwork between them, skillful group pacing, and peer facilitator self-disclosure contributed to a warm, respectful, and interactive group atmosphere, which created an environment conducive to social learning. Guidelines for successful co-facilitation emerging from this work are described.",2021,"Data from a randomized controlled trial of Living Well, a peer and non-peer co-facilitated intervention for medical illness management for adults with serious mental illness, were utilized.","['Adults with Serious Mental Illness', 'A subset of Living Well participants (n\u2009=\u200916) and all peer facilitators (n\u2009=\u20093) completed qualitative interviews', 'adults with serious mental illness', 'Peer specialists, or individuals with lived experience of mental health conditions who support the mental health recovery of others, often work side-by-side with traditional providers (non-peers']","['peer and non-peer co-facilitated intervention', 'examine group participant and peer provider experiences with peer and non-peer group co-facilitation', 'Peer and Non-Peer Co-Facilitation of a Health and Wellness Intervention']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C4505046', 'cui_str': 'Mental Health Recovery'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],,0.0301761,"Data from a randomized controlled trial of Living Well, a peer and non-peer co-facilitated intervention for medical illness management for adults with serious mental illness, were utilized.","[{'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Muralidharan', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA. anjana.muralidharan2@va.gov.'}, {'ForeName': 'Amanda D', 'Initials': 'AD', 'LastName': 'Peeples', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Hack', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Fortuna', 'Affiliation': 'Geisel School of Medicine, Department of Psychiatry, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Klingaman', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Naomi F', 'Initials': 'NF', 'LastName': 'Stahl', 'Affiliation': 'Department of Psychology, American University, Washington, DC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phalen', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Lucksted', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Goldberg', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09818-2']
256,32785710,"Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomized, Double-blind, Phase IIb, Placebo-controlled Trial.","BACKGROUND


Steroid use for coronavirus disease 2019 (COVID-19) is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to evaluate the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19.
METHODS


A parallel, double-blind, placebo-controlled, randomized, Phase IIb clinical trial was performed with hospitalized patients aged ≥18 years with clinical, epidemiological, and/or radiological suspected COVID-19 at a tertiary care facility in Manaus, Brazil. Patients were randomly allocated (1:1 ratio) to receive either intravenous MP (0.5 mg/kg) or placebo (saline solution) twice daily for 5 days. A modified intention-to-treat (mITT) analysis was conducted. The primary outcome was 28-day mortality.
RESULTS


From 18 April to 16 June 2020, 647 patients were screened, 416 were randomized, and 393 were analyzed as mITT, with 194 individuals assigned to MP and 199 to placebo. SARS-CoV-2 infection was confirmed by reverse transcriptase polymerase chain reaction in 81.3%. The mortality rates at Day 28 were not different between groups. A subgroup analysis showed that patients over 60 years old in the MP group had a lower mortality rate at Day 28. Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until Day 7.
CONCLUSIONS


The findings of this study suggest that a short course of MP in hospitalized patients with COVID-19 did not reduce mortality in the overall population.
CLINICAL TRIALS REGISTRATION


NCT04343729.",2021,"Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until day 7.
","['Patients Hospitalized With COVID-19 (Metcovid', 'hospitalized patients with suspected COVID-19', 'From April 18 to June 16, 2020, 647 patients were screened, 416 randomized, and 393 analyzed as mITT, MP in 194 and placebo in 199 individuals', 'hospitalized patients aged ≥ 18 years with clinical, epidemiological and/or radiological suspected COVID-19, at a tertiary care facility in Manaus, Brazil']","['Placebo', 'intravenous MP', 'methylprednisolone (MP', 'placebo (saline solution', 'Methylprednisolone', 'placebo']","['28-day mortality', 'mortality rate', 'virus clearance in respiratory secretion', 'mortality', 'Mortality', 'SARS-CoV-2 infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C1532372', 'cui_str': 'Respiratory secretion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",647.0,0.771386,"Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until day 7.
","[{'ForeName': 'Christiane Maria Prado', 'Initials': 'CMP', 'LastName': 'Jeronimo', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Maria Eduarda Leão', 'Initials': 'MEL', 'LastName': 'Farias', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Fernando Fonseca Almeida', 'Initials': 'FFA', 'LastName': 'Val', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Vanderson Souza', 'Initials': 'VS', 'LastName': 'Sampaio', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcia Almeida Araújo', 'Initials': 'MAA', 'LastName': 'Alexandre', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Gisely Cardoso', 'Initials': 'GC', 'LastName': 'Melo', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Izabella Picinin', 'Initials': 'IP', 'LastName': 'Safe', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Mayla Gabriela Silva', 'Initials': 'MGS', 'LastName': 'Borba', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Rebeca Linhares Abreu', 'Initials': 'RLA', 'LastName': 'Netto', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Alex Bezerra Silva', 'Initials': 'ABS', 'LastName': 'Maciel', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'João Ricardo Silva', 'Initials': 'JRS', 'LastName': 'Neto', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Lucas Barbosa', 'Initials': 'LB', 'LastName': 'Oliveira', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Erick Frota Gomes', 'Initials': 'EFG', 'LastName': 'Figueiredo', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Kelry Mazurega', 'Initials': 'KM', 'LastName': 'Oliveira Dinelly', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Maria Gabriela', 'Initials': 'MG', 'LastName': 'de Almeida Rodrigues', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Brito', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Maria Paula Gomes', 'Initials': 'MPG', 'LastName': 'Mourão', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Guilherme Augusto', 'Initials': 'GA', 'LastName': 'Pivoto João', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Ludhmila Abrahão', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Quique', 'Initials': 'Q', 'LastName': 'Bassat', 'Affiliation': 'Instituto de Salud Global de Barcelona (ISGlobal), Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gustavo Adolfo Sierra', 'Initials': 'GAS', 'LastName': 'Romero', 'Affiliation': 'Núcleo de Medicina Tropical, Universidade de Brasília, Brasília, Brazil.'}, {'ForeName': 'Felipe Gomes', 'Initials': 'FG', 'LastName': 'Naveca', 'Affiliation': 'Instituto Leônidas and Maria Deane, Fiocruz Amazonas, Manaus, Brazil.'}, {'ForeName': 'Heline Lira', 'Initials': 'HL', 'LastName': 'Vasconcelos', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'de Araújo Tavares', 'Affiliation': 'Universidade Federal do Amazonas, Manaus, Brazil.'}, {'ForeName': 'José Diego', 'Initials': 'JD', 'LastName': 'Brito-Sousa', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Fabio Trindade Maranhão', 'Initials': 'FTM', 'LastName': 'Costa', 'Affiliation': 'Universidade Estadual de Campinas, Campinas, Brazil.'}, {'ForeName': 'Maurício Lacerda', 'Initials': 'ML', 'LastName': 'Nogueira', 'Affiliation': 'Faculdade de Medicina de São José do Rio Preto, São José do Rio Preto, Brazil.'}, {'ForeName': 'Djane Clarys', 'Initials': 'DC', 'LastName': 'Baía-da-Silva', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Mariana Simão', 'Initials': 'MS', 'LastName': 'Xavier', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Wuelton Marcelo', 'Initials': 'WM', 'LastName': 'Monteiro', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcus Vinícius Guimarães', 'Initials': 'MVG', 'LastName': 'Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1177']
257,32830463,Kinetic-Pharmacodynamic Model of Platelet Time Course in Patients With Moderate-to-Severe Atopic Dermatitis Treated With Oral Janus Kinase 1 Inhibitor Abrocitinib.,"The oral Janus kinase 1 (JAK1) inhibitor abrocitinib reduced signs and symptoms of atopic dermatitis (AD) in a placebo-controlled, randomized, double-blind, phase IIb trial (dose range 10-200 mg). A kinetic-pharmacodynamic (K-PD) model consisting of proliferation, maturation, and blood circulation compartments was developed to characterize platelet count changes during the study. The K-PD model consisted of a drug elimination constant, four system parameters describing platelet dynamics, variance terms, correlation, and residual errors. Overall, these patients exhibited mean transit time from progenitor cells to platelets of 8.2 days (longer than the reported megakaryocyte life span), likely arising from JAK1-induced perturbations of platelet progenitor homeostasis. The final model described dose-related platelet count declines until nadir at treatment week 4 and return to baseline levels thereafter. The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.",2020,The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.,['Patients With Moderate-to-Severe Atopic Dermatitis'],[],['mean transit time'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.114435,The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Soto', 'Affiliation': 'Pfizer UK Limited, Sandwich, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Peterson', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12548']
258,32806876,Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis.,"BACKGROUND/AIMS


A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation.
METHODS


Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52.
RESULTS


Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, -27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo.
CONCLUSIONS


Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14).",2021,The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV.,"['Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase', '49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6', 'Japanese patients with moderately to severely active ulcerative colitis', 'Japanese patients with moderate to severe ulcerative colitis (UC', 'Japanese patients with UC']","['vedolizumab SC', 'vedolizumab', 'vedolizumab 108 mg SC', 'open-label infusions of vedolizumab', 'vedolizumab subcutaneous (SC) formulation', 'vedolizumab subcutaneous formulation', 'placebo, or vedolizumab', 'placebo']","['clinical remission (complete Mayo score', 'clinical remission', 'Efficacy and safety', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C2742797', 'cui_str': 'vedolizumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",49.0,0.341281,The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV.,"[{'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Infusion clinic, Osaka, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Ashida', 'Affiliation': 'Inflammatory Bowel Disease Center, Sapporo Tokushukai Hospital, Sapporo, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'Yokoyama IBD Clinic, Nagoya, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Nagahori', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Inaba', 'Affiliation': 'Department of Gastroenterology, Kagawa Prefectural Central Hospital, Kagawa, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Shikamura', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Tetsuharu', 'Initials': 'T', 'LastName': 'Hori', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pinton', 'Affiliation': 'Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.'}]",Intestinal research,['10.5217/ir.2020.00026']
259,32826717,"Intervention and Mechanisms of Alanyl-glutamine for Inflammation, Nutrition, and Enteropathy: A Randomized Controlled Trial.","OBJECTIVE


Determine the minimum dosage of alanyl-glutamine (Ala-Gln) required to improve gut integrity and growth in children at risk of environmental enteropathy (EE).
METHODS


This was a double-blinded randomized placebo-controlled dose-response trial. We enrolled 140 children residing in a low-income community in Fortaleza, Brazil. Participants were 2 to 60 months old and had weight-for-age (WAZ), height-for-age (HAZ), or weight-for-height (WHZ) z-scores less than -1. We randomized children to 10 days of nutritional supplementation: Ala-Gln at 3 g/day, Ala-Gln at 6 g/day, Ala-Gln at 12 g/day, or an isonitrogenous dose of glycine (Gly) placebo at 12.5 g/day. Our primary outcome was urinary lactulose-mannitol excretion testing. Secondary outcomes were anthropometry, fecal markers of inflammation, urine metabolic profiles, and malabsorption (spot fecal energy).
RESULTS


Of 140 children, 103 completed 120 days of follow-up (24% dropout). In the group receiving the highest dose of Ala-Gln, we detected a modest improvement in urinary lactulose excretion from 0.19% on day 1 to 0.17% on day 10 (P = 0.05). We observed significant but transient improvements in WHZ at day 10 in 2 Ala-Gln groups, and in WHZ and WAZ in all Ala-Gln groups at day 30. We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose Ala-Gln promotes short-term improvement in gut integrity and ponderal growth in children at risk of EE. Lower doses produced improvements in ponderal growth in the absence of enhanced gut integrity.",2020,"We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose","['140 children residing in a low-income community in Fortaleza, Brazil', 'children at risk of EE', 'Of 140 children, 103 completed 120 days of follow-up (24% dropout', 'children at risk of environmental enteropathy (EE', 'Participants were 2 to 60 months old and had weight-for-age (WAZ), height-for-age (HAZ), or weight-for-height (WHZ) z-scores less than -1', 'participants receiving Ala-Gln.\nCONCLUSIONS\n\n\nIntermediate dose']","['glycine (Gly) placebo', 'nutritional supplementation: Ala-Gln at 3\u200ag/day, Ala-Gln at 6\u200ag/day, Ala-Gln', 'alanyl-glutamine (Ala-Gln', 'placebo']","['anthropometry, fecal markers of inflammation, urine metabolic profiles, and malabsorption (spot fecal energy', 'gut integrity and ponderal growth', 'fecal energy and fecal lactoferrin', 'Inflammation, Nutrition, and Enteropathy', 'urinary lactulose-mannitol excretion testing', 'urinary lactulose excretion', 'fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0051080', 'cui_str': 'alanylglutamine'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0051080', 'cui_str': 'alanylglutamine'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0024523', 'cui_str': 'Malabsorption syndrome'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",140.0,0.33091,"We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose","[{'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Moore', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Quinn', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Maier', 'Affiliation': ""Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Marjorie M', 'Initials': 'MM', 'LastName': 'Guedes', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Josiane S', 'Initials': 'JS', 'LastName': 'Quetz', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Perry', 'Affiliation': ""Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Chethan', 'Initials': 'C', 'LastName': 'Ramprasad', 'Affiliation': 'Department of Internal Medicine, NYU School of Medicine/NYU Langone Medical Center, New York, NY.'}, {'ForeName': 'Gabriela M L', 'Initials': 'GML', 'LastName': 'Lanzarini Lopes', 'Affiliation': 'Department of Emergency Medicine, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Mayneris-Perxachs', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Dr. Josep Trueta University Hospital, and Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Swann', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College, London.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Soares', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'José Q', 'Initials': 'JQ', 'LastName': 'Filho', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Francisco S', 'Initials': 'FS', 'LastName': 'Junior', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Havt', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Noelia L', 'Initials': 'NL', 'LastName': 'Lima', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Guerrant', 'Affiliation': 'Division of Infectious Disease and International Health, Department of Medicine, Center for Global Health, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Aldo A M', 'Initials': 'AAM', 'LastName': 'Lima', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002834']
260,32829526,"Intradialytic isometric handgrip exercise does not cause hemodynamic instability: A randomized, cross-over, pilot study.","Hemodialysis (HD) patients experience hemodynamic instability and intradialytic exercise seems to attenuate it. This study aimed to verify the acute hemodynamic response to different intradialytic handgrip exercise intensities in HD patients. In a randomized, cross-over, experimental pilot study, eight patients completed two experimental sessions and one control in random order: (a) regular HD; (b) low-intensity isometric handgrip exercise; and (c) moderate-intensity isometric handgrip exercise. BP and heart rate variability were recorded immediately before and every 15 minutes. Isometric handgrip exercise protocols, regardless of the intensity, did not lead to significant changes in hemodynamic stability, nor when compared to the control condition (P > .05). The systolic BP and double product significantly increased immediately after the moderate-intensity protocol (122.0 ± 15.9 vs 131.3 ± 19.8, P < .05; 9094.7 ± 1705.7 vs 9783.0 ± 1947.9, P < .05, respectively) but returned to the pre-exercise values 10 minutes later. We conclude that intradialytic isometric handgrip exercise does not induce hemodynamic instability at low and moderate intensities.",2021,"Isometric handgrip exercise protocols, regardless of the intensity, did not lead to significant changes in hemodynamic stability, nor when compared to the control condition (p>0.05).","['Hemodialysis patients experience hemodynamic instability', 'hemodialysis patients']","['Isometric handgrip exercise protocols', 'Intradialytic Isometric Handgrip Exercise', 'intradialytic handgrip exercise intensities', 'intradialytic isometric handgrip exercise', 'regular hemodialysis, ii) low-intensity isometric handgrip exercise, and ii) moderate-intensity isometric handgrip exercise', 'Intradialytic exercise']","['hemodynamic instability', 'hemodynamic stability', 'systolic blood pressure', 'Cause Hemodynamic Instability', 'Blood pressure and heart rate variability']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",8.0,0.0224199,"Isometric handgrip exercise protocols, regardless of the intensity, did not lead to significant changes in hemodynamic stability, nor when compared to the control condition (p>0.05).","[{'ForeName': 'Heitor S', 'Initials': 'HS', 'LastName': 'Ribeiro', 'Affiliation': 'Faculty of Physical Education, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Vinícius A', 'Initials': 'VA', 'LastName': 'Cunha', 'Affiliation': 'Faculty of Health Science, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Baiao', 'Affiliation': 'Interdisciplinary Research Department, University Center ICESP, Brasília, Brazil.'}, {'ForeName': 'Lucas S', 'Initials': 'LS', 'LastName': 'Almeida', 'Affiliation': 'Faculty of Physical Education, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Gustavo Í', 'Initials': 'GÍ', 'LastName': 'Dourado', 'Affiliation': 'Faculty of Health Science, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Helton L', 'Initials': 'HL', 'LastName': 'Carvalho', 'Affiliation': 'Interdisciplinary Research Department, University Center ICESP, Brasília, Brazil.'}, {'ForeName': 'Marvery P', 'Initials': 'MP', 'LastName': 'Duarte', 'Affiliation': 'Faculty of Physical Education, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Antônio', 'Initials': 'A', 'LastName': 'Inda-Filho', 'Affiliation': 'Interdisciplinary Research Department, University Center ICESP, Brasília, Brazil.'}, {'ForeName': 'João L', 'Initials': 'JL', 'LastName': 'Viana', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University Institute of Maia (ISMAI), Porto, Portugal.'}, {'ForeName': 'Otávio T', 'Initials': 'OT', 'LastName': 'Nóbrega', 'Affiliation': 'Faculty of Health Science, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Aparecido P', 'Initials': 'AP', 'LastName': 'Ferreira', 'Affiliation': 'Interdisciplinary Research Department, University Center ICESP, Brasília, Brazil.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13581']
261,32831169,A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini.,"Background


Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy’s impact on the economic aspects of patients' lives remains unknown.
Methods


We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients’ individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of <350 cells/mm3 until September 2016 and <500 cells/mm3 thereafter) to the ‘Early Initiation of ART for All’ (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data were collected via standardised paper-based surveys with HIV-positive adults who were neither pregnant nor breastfeeding. Outcomes were patients’ time use, employment status, household expenditures, and household living standards.
Results


A total sample of 3019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility per time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering at the level of the healthcare facility, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR = 1.00 [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR = 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households’ asset ownership and living standards (RR = 0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients’ sex, age, education, timing of HIV diagnosis and ART initiation.
Conclusions


Our findings do not provide evidence that should discourage further investments into scaling up immediate ART for all HIV patients.
Funding


Funded by the Dutch Postcode Lottery in the Netherlands, Alexander von Humboldt-Stiftung (Humboldt-Stiftung), the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique, British Columbia Centre of Excellence in Canada, Doctors Without Borders (MSF USA), National Center for Advancing Translational Sciences of the National Institutes of Health and Joachim Herz Foundation.
Clinical trial number


NCT02909218 and NCT03789448.",2020,"Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93","['Fourteen healthcare facilities', ""HIV patients' economic welfare in Eswatini"", ""patients' economic welfare"", 'A total sample of 3,019 participants were interviewed over the duration of the study']","['immediate ART initiation', 'antiretroviral therapy (ART']","['Employment and household expenditures', 'time use, employment status, household expenditures and household wealth', 'non-resting time use']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",3019.0,0.412335,"Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93","[{'ForeName': 'Janina Isabel', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Shaukat', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Khudzie', 'Initials': 'K', 'LastName': 'Mlambo', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Walsh', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mafara', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lejeune', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Cebele', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Osondu', 'Initials': 'O', 'LastName': 'Ogbuoji', 'Affiliation': 'Center for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, United States.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Vollmer', 'Affiliation': 'University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Jan-Walter', 'Initials': 'JW', 'LastName': 'De Neve', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Sikhathele', 'Initials': 'S', 'LastName': 'Mazibuko', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Velephi', 'Initials': 'V', 'LastName': 'Okello', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Geldsetzer', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}]",eLife,['10.7554/eLife.58487']
262,32800815,Randomized Controlled Early versus Late Ventricular Intervention Study in Posthemorrhagic Ventricular Dilatation: Outcome at 2 Years.,"OBJECTIVE


To compare the effect of intervention at low vs high threshold of ventriculomegaly in preterm infants with posthemorrhagic ventricular dilatation on death or severe neurodevelopmental disability.
STUDY DESIGN


This multicenter randomized controlled trial reviewed lumbar punctures initiated after either a low threshold (ventricular index of >p97 and anterior horn width of >6 mm) or high threshold (ventricular index of >p97 + 4 mm and anterior horn width of >10 mm). The composite adverse outcome was defined as death or cerebral palsy or Bayley composite cognitive/motor scores <-2 SDs at 24 months corrected age.
RESULTS


Outcomes were assessed in 113 of 126 infants. The composite adverse outcome was seen in 20 of 58 infants (35%) in the low threshold group and 28 of 55 (51%) in the high threshold (P = .07). The low threshold intervention was associated with a decreased risk of an adverse outcome after correcting for gestational age, severity of intraventricular hemorrhage, and cerebellar hemorrhage (aOR, 0.24; 95% CI, 0.07-0.87; P = .03). Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference, -0.06; 95% CI, -0.09 to -0.03; P < .001) at term-equivalent age. Infants in the low threshold group with a ventriculoperitoneal shunt, had cognitive and motor scores similar to those without (P = .3 for both), whereas in the high threshold group those with a ventriculoperitoneal shunt had significantly lower scores than those without a ventriculoperitoneal shunt (P = .01 and P = .004, respectively).
CONCLUSIONS


In a post hoc analysis, earlier intervention was associated with a lower odds of death or severe neurodevelopmental disability in preterm infants with progressive posthemorrhagic ventricular dilatation.
TRIAL REGISTRATION


ISRCTN43171322.",2020,"Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference: -0.06, 95% CI","['preterm infants with posthemorrhagic ventricular dilatation on death or severe neurodevelopmental disability', 'Posthemorrhagic Ventricular Dilatation', 'preterm infants with progressive posthemorrhagic ventricular dilatation']","['LT intervention', 'Late Ventricular Intervention Study (ELVIS']","['death or severe neurodevelopmental disability', 'intraventricular hemorrhage and cerebellar hemorrhage', 'cognitive and motor scores', 'risk of an adverse outcome', 'composite adverse outcome', 'death or cerebral palsy or Bayley composite cognitive/motor scores <-2 standard deviations', 'smaller fronto-occipital horn ratio']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4552505', 'cui_str': 'PHVD'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0648185', 'cui_str': 'glutamyl-leucyl-valyl-isoleucyl-serine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0149854', 'cui_str': 'Cerebellar hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0152282', 'cui_str': 'Structure of posterior horn of lateral ventricle'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.200645,"Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference: -0.06, 95% CI","[{'ForeName': 'Mehmet N', 'Initials': 'MN', 'LastName': 'Cizmeci', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands; Division of Neonatology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Floris', 'Initials': 'F', 'LastName': 'Groenendaal', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands.""}, {'ForeName': 'Kian D', 'Initials': 'KD', 'LastName': 'Liem', 'Affiliation': ""Department of Neonatology, Amalia Children's Hospital, Radboud University Medical Center, Nijmegen, the Netherlands.""}, {'ForeName': 'Ingrid C', 'Initials': 'IC', 'LastName': 'van Haastert', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Benavente-Fernández', 'Affiliation': ""Department of Neonatology, 'Puerta del Mar' University Hospital, Cadiz, Spain.""}, {'ForeName': 'Henrica L M', 'Initials': 'HLM', 'LastName': 'van Straaten', 'Affiliation': ""Department of Neonatology, Isala Women and Children's Hospital, Zwolle, the Netherlands.""}, {'ForeName': 'Sylke', 'Initials': 'S', 'LastName': 'Steggerda', 'Affiliation': 'Department of Neonatology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Bert J', 'Initials': 'BJ', 'LastName': 'Smit', 'Affiliation': 'Directorate Quality & Patient Care, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Whitelaw', 'Affiliation': 'Neonatal Intensive Care Unit, Southmead Hospital and Neonatal Neuroscience, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Woerdeman', 'Affiliation': 'Division of Neuroscience, Department of Neurosurgery, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Heep', 'Affiliation': 'Neonatal Intensive Care Unit, Southmead Hospital and Neonatal Neuroscience, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'de Vries', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands. Electronic address: l.s.devries@umcutrecht.nl.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.014']
263,32805434,Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial.,"INTRODUCTION


Although as many as 75% of the >2 million annual intensive care unit (ICU) survivors experience symptoms of psychological distress that persist for months to years, few therapies exist that target their symptoms and accommodate their unique needs. In response, we developed LIFT, a mobile app-based mindfulness intervention. LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
OBJECTIVE


To describe the methods of a factorial experimental clinical trial (LIFT2) being conducted to aid in the development and implementation of the version of the LIFT intervention that is optimized across domains of effect, feasibility, scalability, and costs.
METHODS AND ANALYSIS


The LIFT2 study is an optimization trial conceptualized as a component of a larger multiphase optimization strategy (MOST) project. The goal of LIFT2 is to use a 2 × 2 × 2 factorial experimental trial involving 152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose. The primary trial outcome is change in depression symptoms 1 month from randomization measured by the PHQ-9 instrument. Secondary outcomes include anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability; as well as themes assessed through qualitative analysis of semi-structured interviews with study participants conducted after follow up completion. We will use general linear models to compare outcomes across the main effects and interactions of the factors.",2020,"LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
","['152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose', ""cardiorespiratory failure survivors' psychological distress (LIFT2""]","['self-directed mobile mindfulness intervention', 'LIFT intervention', 'telephone-based mindfulness program or education control']","['change in depression symptoms 1\u202fmonth from randomization measured by the PHQ-9 instrument', 'LIFT reduced distress symptoms', 'anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1444565', 'cui_str': 'Cardiorespiratory failure'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",152.0,0.143957,"LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: christopher.cox@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Medical Center, Durham, NC, United States of America. Electronic address: maren.olsen@duke.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gallis', 'Affiliation': 'Department of Biostatistics & Bioinformatics, Duke Global Health Institute, Duke University, Durham, NC, United States of America. Electronic address: john.gallis@duke.edu.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: laura.porter@duke.edu.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Greeson', 'Affiliation': 'Department of Psychology, College of Science and Mathematics, Rowan University, Glassboro, NJ, United States of America. Electronic address: greeson@rowan.edu.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Gremore', 'Affiliation': 'Department of Psychology, College of Science and Mathematics, Rowan University, Glassboro, NJ, United States of America. Electronic address: tina.gremore@duke.edu.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Frear', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: allie.frear@duke.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ungar', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: amu@uw.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'McKeehan', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: jeffrey.mckeehan@cuanschutz.edu.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'McDowell', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: brittany.mcdowell@duke.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McDaniel', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: hannah.mcdaniel@cuanschutz.edu.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: marc.moss@cuanschutz.edu.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: houghc@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106119']
264,32814658,"The low power effect on holmium laser enucleation of prostate (HoLEP); A comparison between 20W and 37,5W energy regarding apical enucleation efficacy and patient safety.","INTRODUCTION


The Holmium laser has proven to be an invaluable tool for endoscopic prostate enucleation. The proper energy selection, during the different steps of the procedure, has always been a matter of debate. In this work we compare the effectiveness of the Holmium laser, using two different low-power energy settings, during enucleation and hemostasis (20W and 37.5W).
METHODS


One hundred and sixty patients underwent a HoLEP procedure with a 50Hz and 2J (100W) setting. During enuleation and hemostasis, two different low-power settings were applied (20W vs. 37.5W). In both groups, only the prostatic tissue in the bladder neck and enucleated tissue far away from the apex, were cut with a setting of 50Hz and 2J (100W).
RESULTS


The mean enucleation efficiency (0.78 vs. 1.2g/min-p:001) was significantly higher by utilizing 37.5W energy (group 2). Additionally, the mean enucleation rate (0.64 vs. 0.88%-P:0.001) and laser efficiency (2.07 vs. 2.12 joule/g-P:0.003) were significantly higher in group 2. The enucleation time was significantly shorter (54 vs. 75.5 mins-P:0.002), while the mean catheter removal time (27 vs. 42 hrs-P:0.008) and Hb decrease (0.5 vs. 0.6g/dl--P:0.019) were significantly lower in group 2.
CONCLUSIONS


HoLEP can be performed efficiently with 100 W-37.5W settings. Enucleation and hemostasis can be performed successfully with 37.5W, while the use of 100W during bladder neck dissection shortens the duration of the procedure.
LEVEL OF EVIDENCE


3.",2020,"The enucleation time was significantly shorter (54 vs. 75.5 mins-P:0.002), while the mean catheter removal time (27 vs. 42 hrs-P:0.008) and Hb decrease (0.5 vs. 0.6g/dl--P:0.019) were significantly lower in group 2.
",['One hundred and sixty patients underwent a HoLEP procedure with a 50Hz and 2J (100W) setting'],"['holmium laser enucleation of prostate (HoLEP', 'Holmium laser']","['laser efficiency', 'mean enucleation rate', 'mean enucleation efficiency', 'mean catheter removal time', 'enucleation time']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C3698057', 'cui_str': 'Holmium laser enucleation of prostate'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",160.0,0.0354903,"The enucleation time was significantly shorter (54 vs. 75.5 mins-P:0.002), while the mean catheter removal time (27 vs. 42 hrs-P:0.008) and Hb decrease (0.5 vs. 0.6g/dl--P:0.019) were significantly lower in group 2.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gazel', 'Affiliation': 'Acibadem University Ankara Hospital, Department of Urology, Ankara, Turkey. Electronic address: eymen_gazel@yahoo.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kaya', 'Affiliation': 'Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yalcın', 'Affiliation': 'Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tokas', 'Affiliation': 'General Hospital Hall i.T., Hall in Tirol, Department of Urology and Andrology, Austria.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Aybal', 'Affiliation': 'Ankara Oncology Training and Research Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yılmaz', 'Affiliation': 'Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Aydogan', 'Affiliation': 'Goksun State Hospital, Department of Urology, Kahramanmaras, Turkey.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tunc', 'Affiliation': 'Gazi University School of Medicine, Department of Urology, Ankara, Turkey.'}]",Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie,['10.1016/j.purol.2020.05.009']
265,32828993,Comparison of different surgical procedures on the stability of dental implants in posterior maxilla: A randomized clinical study.,"BACKGROUND


Stability of a dental implant is very important when planning immediate loading and design of a final restoration. The aim of this study was to compare the primary and the secondary stability of dental implants inserted by three different surgical techniques: conventional (standard) technique using a sequence of drills for implant bed preparation, osteotome technique using tapered hand instruments for creating implant sites by condensing the bone and guided flapless implant surgery with surgical templates.
MATERIAL AND METHODS


The study included 150 patients (80 males and 70 females), 46-71 years old, who required implant supported fixed partial dentures in the posterior maxilla of D3 or D4 bone density. Patients were randomly assigned into one of the three surgical insertion technique groups. All patients received tapered implants of the same manufacturer of the same length and two different widths (3.3 × 11.5 mm or 4.2 × 11.5 mm). Primary and secondary implant stability were measured by means of resonance frequency analysis (RFA) at the time of implant placement and 5 months after surgery using the Ostell ISQ device (Osstell AB, Sampgatan, Goteborg, Sweden). Statistical analysis included one-sample Kolmogorov Smirnov test, descriptive statistics, multivariate analysis (Bonferoni post-hoc tests) and paired t-tests.
RESULTS


Patients in the osteotome group exhibited higher primary stability (P < 0.01) than in the conventional and surgically guided flapless groups. There were no significant differences in the secondary stability (p >  0.05). Wider implants presented higher ISQ values (P<0.01).
CONCLUSION


The osteotome technique led to the highest implant primary stability, therefore it can be recommended when immediate loading is planned or for one-piece implant insertion.",2021,"RESULTS


Patients in the osteotome group exhibited higher primary stability (P < 0.01) than in the conventional and surgically guided flapless groups.","['Posterior Maxilla', '150 patients (80 males and 70 females), 46-71 years old, who required implant supported fixed partial dentures in the posterior maxilla of D3 or D4 bone density']",['surgical techniques: conventional (standard) technique'],"['ISQ values', 'Ostell ISQ device (Osstell AB, Sampgatan, Goteborg, Sweden', 'stability of Dental Implants', 'secondary stability', 'primary stability']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",150.0,0.114953,"RESULTS


Patients in the osteotome group exhibited higher primary stability (P < 0.01) than in the conventional and surgically guided flapless groups.","[{'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Planinić', 'Affiliation': 'Private Dental Office, Medjugorje, Bosnia and Hercegovina.'}, {'ForeName': 'Ivica', 'Initials': 'I', 'LastName': 'Dubravica', 'Affiliation': 'Private Dental Office, Vodice, Croatia.'}, {'ForeName': 'Zdenko', 'Initials': 'Z', 'LastName': 'Šarac', 'Affiliation': 'Department of Head and Neck Diseases, School of Medicine, University of Mostar, Mostar, Bosnia and Hercegovina.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Poljak-Guberina', 'Affiliation': 'Department of Dental Prosthetics, School of Medicine, University of Split, Split, Croatia. Electronic address: poljak@sfzg.hr.'}, {'ForeName': 'Asja', 'Initials': 'A', 'LastName': 'Celebic', 'Affiliation': 'Department of Removable Prosthodontics, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Bago', 'Affiliation': 'Department of Endodontics and Restorative Dentistry, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Cabov', 'Affiliation': 'Department of Oral Surgery, School of Dental Medicine, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Berislav', 'Initials': 'B', 'LastName': 'Peric', 'Affiliation': 'Department of Oral Surgery, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2020.08.004']
266,32803473,"Reliability, Validity and Responsiveness of the EQ-5D-5L in Assessing and Valuing Health Status in Adolescents and Young Adults with Posttraumatic Stress Disorder: a Randomized Controlled Trail.","To validate the EQ-5D-5L health-related quality of life (HrQoL) questionnaire in adolescents and young adults with posttraumatic stress disorder (PTSD) after sexual and/or physical abuse. We used data from a randomized controlled trial of 87 participants with PTSD aged 14-21 years. The discriminative ability was evaluated by comparing participants scores on the descriptive system of the EQ-5D-5L with general population scores. Furthermore, the discriminative ability between subgroups of participants with different disease severity levels was estimated. Correlations between the EQ-5D index and clinical parameters were used to measure construct validity. Test-retest reliability was measured by intraclass correlation coefficients (ICC) between baseline, posttreatment and 3-month follow-up scores of participants with stable symptoms. Finally, the responsiveness of the EQ-5D was calculated by mean differences, effect sizes and receiver operating characteristic (ROC) analyses for participants with improved symptoms. Participants reported significantly more problems on the dimensions ""mobility"", ""usual activities"", ""pain/discomfort"" and ""anxiety/depression"" than the general population. The EQ-5D-5L was able to discriminate between different disease severity levels. The EQ-5D index and clinical scales were significantly correlated with absolute values of correlation coefficients varying between 0.21 and 0.59. Furthermore, ICCs between 0.65 and 0.91 indicated good test-retest reliability for the EQ-5D index. The ICCs for the EQ-VAS between baseline and 3-month follow-up, and posttreatment and 3-month follow-up were statistically significant with 0.71 and 0.87, respectively, whereas the ICC between baseline and posttreatment was 0.08 and not statistically significant. Effect sizes to measure the responsiveness ranged between -0.008 and 0.40 for the EQ-5D index and - 0.32 and 0.40 for the EQ-VAS. Furthermore, the area under the curve in ROC analyses was between 0.40 and 0.64 for the EQ-5D index and 0.60 and 0.70 for the EQ-VAS. Discriminative ability, test-retest reliability and construct validity of the EQ-5D-5L were good, whereas the responsiveness was rather weak. Nevertheless, the EQ-5D-5L can be used to measure HrQoL in adolescents and young adults with PTSD. German Clinical Trials Register identifier: DRKS00004787; date of registration: 18th March 2013; https://www.drks.de.",2021,Effect sizes to measure the responsiveness ranged between -0.008 and 0.40 for the EQ-5D index and - 0.32 and 0.40 for the EQ-VAS.,"['adolescents and young adults with PTSD', 'adolescents and young adults with posttraumatic stress disorder (PTSD) after sexual and/or physical abuse', '87 participants with PTSD aged 14-21\xa0years', 'Adolescents and Young Adults with Posttraumatic Stress Disorder']",['EQ-5D-5L'],"['effect sizes and receiver operating characteristic (ROC) analyses', 'Test-retest reliability', 'EQ-5D index and clinical scales', 'EQ-5D-5L health-related quality of life (HrQoL) questionnaire', 'Reliability, Validity and Responsiveness of the EQ-5D-5L in Assessing and Valuing Health Status', 'dimensions ""mobility"", ""usual activities"", ""pain/discomfort"" and ""anxiety/depression', 'Discriminative ability, test-retest reliability and construct validity', 'discriminative ability']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1621955', 'cui_str': 'Physical abuse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]",87.0,0.0473357,Effect sizes to measure the responsiveness ranged between -0.008 and 0.40 for the EQ-5D index and - 0.32 and 0.40 for the EQ-VAS.,"[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Dams', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics (HCHE), University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. j.dams@uke.de.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Rimane', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Steil', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Babette', 'Initials': 'B', 'LastName': 'Renneberg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Freie Universitaet Berlin, Berlin, Germany.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Rosner', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics (HCHE), University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09814-6']
267,32811625,Temporal dynamics of the relationship between change in depressive symptoms and cannabis use in adolescents receiving psychosocial treatment for cannabis use disorder.,"AIMS


Cannabis use disorder (CUD) and depression frequently co-occur in youth. How depressive symptoms change over the course of CUD treatment and how they impact substance use treatment outcomes is unknown. In the current study, we examine the temporal relationships between cannabis use and depression in adolescents receiving evidence-based treatments for CUD as part of a multisite clinical trial.
DESIGN


Six hundred adolescents (age 12-18) with a CUD were randomly assigned to substance use treatment from one of five evidence-based psychosocial interventions. We assessed self-reported cannabis use frequency and depressive symptoms at baseline (BL) and again at 3-, 6-, 9, and 12-months. A bivariate latent change model assessed bidirectional effects of baseline levels and time-lagged changes in depressive symptoms and cannabis use on depression and cannabis use outcomes.
FINDINGS


Depressive symptoms (72%) and major depressive disorder (MDD) (18%) were common at BL. Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003). Time-lag analyses showed that within-subject change in depression (from one time point to the next) was predicted by previous depression (b = -0.71, p < .001) but not cannabis use (p = .068), and change (decrease) in cannabis use was predicted by previous (greater) depressive symptoms (b = -1.47, p < .001) but not cannabis use (p = .158), respectively.
CONCLUSION


These findings indicate an enduring relationship between decreasing cannabis use and decreasing depression among adolescents lasting for 9-months after receiving psychosocial interventions for CUD. The presence of depressive symptoms did not appear to interfere with substance use treatment or attenuate improvements in cannabis use frequency. A decrease in cannabis use was not contingent upon a reduction in depressive symptoms. These findings are limited by the possibility of regression to the mean for both cannabis use and depressive symptoms, and the lack of a nonintervention control group.",2020,"Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003).","['adolescents receiving psychosocial treatment for cannabis use disorder', 'adolescents receiving evidence-based treatments for CUD as part of a multisite clinical trial', 'Six hundred adolescents (age 12-18) with a CUD']",[],"['major depressive disorder (MDD', 'depression', 'depressive symptoms', 'Depressive symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",600.0,0.127233,"Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003).","[{'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Arias', 'Affiliation': 'Virginia Commonwealth University, United States of America. Electronic address: albert.arias@vcuhealth.edu.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hammond', 'Affiliation': 'Johns Hopkins University School of Medicine, United States of America. Electronic address: chammo20@jhmi.edu.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Burleson', 'Affiliation': 'University of Connecticut School of Medicine, United States of America. Electronic address: burleson@uchc.edu.'}, {'ForeName': 'Yifrah', 'Initials': 'Y', 'LastName': 'Kaminer', 'Affiliation': 'University of Connecticut School of Medicine, United States of America. Electronic address: kaminer@uchc.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Feinn', 'Affiliation': 'Quinnipiac University School of Medicine, United States of America. Electronic address: richard.feinn@quinnipiac.edu.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Curry', 'Affiliation': 'Duke University School of Medicine, United States of America. Electronic address: john.curry@duke.edu.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Dennis', 'Affiliation': 'Chestnut Health Systems, United States of America. Electronic address: mdennis@chestnut.org.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108087']
268,32828873,Randomized Controlled Trial of Over-the-Scope Clip as Initial Treatment of Severe Nonvariceal Upper Gastrointestinal Bleeding.,"BACKGROUND AND AIMS


No prior randomized controlled trial (RCT) has reported patient outcomes of large over-the-scope clip (OTSC) compared to standard hemostasis as initial endoscopic treatment of severe NVUGIB. This was our study aim.
METHODS


Patients with bleeding ulcers or Dieulafoy's lesions and major stigmata of hemorrhage - SRH (active spurting bleeding, visible vessel, or clot) - or lesser SRH (oozing bleeding or flat spots - with arterial blood flow by Doppler probe) were randomized to OTSC or standard endoscopic hemostasis (with hemoclips or multipolar electrocoagulation - MPEC). Patients and their healthcare providers were blinded to treatments and made all post-randomization management decisions. Ulcer patients received high dose intravenous infusions of proton pump inhibitors (PPI) for 3 days, then 27 days of oral PPI. 30 day outcomes were prospectively recorded; data management was with SAS; and data analysis was by a statistician.
RESULTS


53 patients (25 OTSC, 28 Standard) were randomized, with similar baseline risk factors. However, there were significant differences in OTSC vs. Standard groups in rates of rebleeding (4% vs. 28.6%; p = .017; relative risk 0.10, 95% confidence intervals 0.01, 0.91; number needed to treat 4); severe complications (0 % vs. 14.3%); and post-randomization units of red cell transfusions (0.04 vs. 0.68). All rebleeds occurred in patients with major SRH and none with lesser SRH.
CONCLUSION


1. OTSC significantly reduced rates of rebleeding, severe complications, and post-randomization red cell transfusions. 2. Patients with major stigmata benefited significantly from hemostasis with OTSC, but those with lesser stigmata did not. (ClinicalTrials.gov, Number: NCT03065465).",2021,"OTSC significantly reduced rates of rebleeding, severe complications, and post-randomization red cell transfusions.","['53 patients (25 OTSC, 28 Standard', ""Patients with bleeding ulcers or Dieulafoy's lesions and major stigmata of hemorrhage - SRH (active spurting bleeding, visible vessel, or clot) - or lesser SRH (oozing bleeding or flat spots - with arterial blood flow by Doppler probe"", 'Severe Non-Variceal Upper Gastrointestinal Bleeding', 'Ulcer patients']","['OTSC or standard endoscopic hemostasis (with hemoclips or multipolar electrocoagulation - MPEC', 'Scope Clip', 'OTSC', 'proton pump inhibitors (PPI']","['number needed to treat 4); severe complications', 'rates of rebleeding', 'rates of rebleeding, severe complications, and post-randomization red cell transfusions', 'hemostasis with OTSC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0333291', 'cui_str': 'Bleeding ulcer'}, {'cui': 'C0341217', 'cui_str': ""Dieulafoy's vascular malformation""}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0441086', 'cui_str': 'Doppler probe'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]","[{'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085148', 'cui_str': 'Endoscopic Hemostasis'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]",2.0,0.223487,"OTSC significantly reduced rates of rebleeding, severe complications, and post-randomization red cell transfusions.","[{'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Jensen', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California; West Los Angeles Veterans Administration Medical Center, Los Angeles, California. Electronic address: djensen@mednet.ucla.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kovacs', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Ghassemi', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kaneshiro', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gornbein', 'Affiliation': 'Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California; Department of Medical Statistics Core, Division of General Internal Medicine, Department of Medicine, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.08.046']
269,32801008,Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis.,"BACKGROUND & AIMS


Histologic features of inflammation (histologic inflammation) are associated with clinical relapse in patients with ulcerative colitis (UC). Concentration of fecal calprotectin (FC) can be used to identify patients with mucosal inflammation. We aimed to assess the accuracy of FC measurements in identifying patients with histologic inflammation and to develop a model to predict outcomes of therapy.
METHODS


We performed a post hoc analysis of data from a phase 4 trial of the efficacy of multimatrix mesalamine in patients with mild to moderate UC (the MOMENTUM trial). We obtained clinical, endoscopic, and histologic data from week 8 (n = 639) and week 52 (n = 373) of the trial. We used area under the receiver operating characteristic curves to determine the accuracy and optimal cut-off values of FC in identifying patients with different therapeutic outcomes (clinical remission, endoscopic healing, deep remission, or histologic remission) at week 8 and week 52. We performed multivariable logistic regression analyses to identify factors associated with these outcomes.
RESULTS


Median FC concentrations were lower in patients who achieved outcomes of clinical remission, endoscopic healing, deep remission, or histologic remission vs patients who did not. FC concentrations identified patients with endoscopic healing and histologic remission with area under the receiver operating characteristic curve values of 0.77 and 0.76 at week 8, and 0.79 and 0.80 at week 52, respectively. The optimal FC cut-off concentrations for identification of patients with histologic remission were 75 μg/g at week 8 and 99 μg/g at week 52. In the subpopulation with an endoscopy score of 0, median FC concentrations were lower in patients with histologic remission than in patients with microscopic inflammation at week 8 (30 vs 140 μg/g; area under the receiver operating characteristic, 0.72) and week 52 (21.5 vs 134.5 μg/g; area under the receiver operating characteristic, 0.71). At both time points, the optimal FC cut-off concentration was approximately 75 μg/g. Our final prediction model for week 52 histologic remission comprised endoscopic score at week 8, FC concentration at week 8, and histologic activity at baseline and week 8.
CONCLUSIONS


A post hoc analysis of data from a phase 4 trial found that, even in patients with complete endoscopic healing of UC, FC concentration can be used to discriminate patients with ongoing microscopic inflammation from patients with histologic remission. The optimal cut-off concentration of FC is between 75 and 100 μg/g. ClinicalTrials.gov no: NCT01124149.",2021,"RESULTS


Median FC concentrations were lower in patients who achieved outcomes of clinical remission, endoscopic healing, deep remission, or histologic remission vs patients who did not.","['patients with mucosal inflammation', 'patients with mild to moderate UC', 'Patients With Ulcerative Colitis', 'patients with histologic inflammation', 'patients with ulcerative colitis (UC']",['multi-matrix mesalamine'],"['median FC concentrations', 'histologic activity', 'FC concentration', 'therapeutic outcomes (clinical remission, endoscopic healing, deep remission, or histologic remission', 'clinical remission, endoscopic healing, deep remission, or histologic remission', 'Median FC concentrations', 'Concentration of fecal calprotectin (FC', 'optimal FC cutoff concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",,0.0659612,"RESULTS


Median FC concentrations were lower in patients who achieved outcomes of clinical remission, endoscopic healing, deep remission, or histologic remission vs patients who did not.","[{'ForeName': 'Toer W', 'Initials': 'TW', 'LastName': 'Stevens', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Gecse', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jerrold R', 'Initials': 'JR', 'LastName': 'Turner', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'de Hertogh', 'Affiliation': 'Department of Pathology, Catholic University Leuven, Leuven, Belgium.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Rubin', 'Affiliation': 'Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: g.dhaens@amc.uva.nl.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.08.019']
270,32847643,Feasibility and acceptability evaluation of the Promoting Independence in Dementia (PRIDE) intervention for living well with dementia.,"OBJECTIVES


Post-diagnostic psychosocial interventions could play an important role in supporting people with mild dementia remain independent. The Promoting Independence in Dementia (PRIDE) intervention was developed to address this.
METHOD


The mixed methods non-randomized, pre-post feasibility study occurred across England. Facilitators were recruited from the voluntary sector and memory services. Participants and their supporters took part in the three-session intervention. Outcome measures were collected at baseline and follow-up. To evaluate acceptability, focus groups and interviews were conducted with a subsample of participants and facilitators.
RESULTS


Contextual challenges to delivery including national research governance changes, affected recruitment of study sites. Thirty-four dyads consented, with 14 facilitators providing the intervention. Dyads took part in at least two sessions (79%), and 73% in all three. Outcome measures were completed by 79% without difficulty, with minimal missing data. No significant changes were found on pre and post assessments. Post hoc analysis found moderate effect size improvements for self-management (SMAS instrument) in people with dementia (d = 0.41) and quality of life (EQ5D measure) in carers (d = 0.40). Qualitative data indicated that dyads found PRIDE acceptable, as did intervention facilitators.
CONCLUSIONS


The three-session intervention was well accepted by participant-dyads and intervention facilitators. A randomized controlled trial of PRIDE would need to carefully consider recruitment potential across geographically varied settings and site stratification according to knowledge of contextual factors, such as the diversity of post-diagnostic services across the country. Letting sites themselves be responsible for identifying suitable intervention facilitators was successful. The self-report measures showed potential to be included in the main trial.",2021,Post hoc analysis found moderate effect size improvements for self-management (SMAS instrument) in people with dementia (d = 0.41) and quality of life (EQ5D measure) in carers (d = 0.40).,"['Dementia (PRIDE) intervention for living well with dementia', 'Thirty-four dyads consented, with 14 facilitators providing the intervention']",[],['quality of life (EQ5D measure'],"[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",34.0,0.067419,Post hoc analysis found moderate effect size improvements for self-management (SMAS instrument) in people with dementia (d = 0.41) and quality of life (EQ5D measure) in carers (d = 0.40).,"[{'ForeName': 'Emese', 'Initials': 'E', 'LastName': 'Csipke', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Esme', 'Initials': 'E', 'LastName': 'Moniz-Cook', 'Affiliation': 'Faculty of Health Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'Phuong', 'Initials': 'P', 'LastName': 'Leung', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Yates', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Birt', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Walton', 'Affiliation': 'Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Eef', 'Initials': 'E', 'LastName': 'Hogervorst', 'Affiliation': 'National Centre for Sports and Exercise Medicine, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mountain', 'Affiliation': 'Centre for Applied Dementia Studies, University of Bradford, Bradford, UK.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Charlesworth', 'Affiliation': 'Clinical Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orrell', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, UK.'}]",International psychogeriatrics,['10.1017/S1041610220001386']
271,32806958,"Disgusting Face, Disease-Ridden Place?: Emoji Influence on the Interpretation of Restaurant Inspection Reports.","Every year, millions of Americans get sick from foodborne illness and it is estimated half of all reported instances occur at restaurants. To protect the public, regulators are encouraged to conduct restaurant inspections and disclose reports to consumers. However, inspection reporting format is inconsistent and typically contains information unclear to most consumers who often misinterpret the inspection results. Additionally, consumers are increasingly searching for this information in a digital context. Limited research explores inspection reports as communication tools. Using affect-as-information and ELM as theoretical frameworks, this experiment investigated how discrete emotions (e.g., disgust) conveyed through pictorial cues (i.e., emojis) influenced consumers' processing of inspection reports. Participants, recruited from Amazon's MTurk, were randomly assigned to one of six experimental conditions in a 3 (emoji: smiling vs. disgusted vs. none) x 2 (violation level: low vs. high) between-subjects design. Then, participants completed a questionnaire regarding perceptions and cognitive processing of the message. Results revealed that, compared to text, disgusted face emoji increased risk perceptions and avoidance behavior. In terms of emotion, smiling face emoji motivated participants to feel more emotions related to sanitation. In turn, positive feelings decreased elaboration likelihood. As predicted by ELM, involvement also predicted elaboration, such that participants who were highly involved with inspection reports elaborated more than those less involved. Involvement also moderated the relationship between emoji presented and elaboration. Practical implications are also discussed.",2021,"As predicted by ELM, involvement also predicted elaboration, such that participants who were highly involved with inspection reports elaborated more than those less involved.","[""Participants, recruited from Amazon's MTurk""]",[],['risk perceptions and avoidance behavior'],"[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}]",,0.0216902,"As predicted by ELM, involvement also predicted elaboration, such that participants who were highly involved with inspection reports elaborated more than those less involved.","[{'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Ray', 'Affiliation': 'School of Communication, Florida State University.'}, {'ForeName': 'Patrick F', 'Initials': 'PF', 'LastName': 'Merle', 'Affiliation': 'School of Communication, Florida State University.'}]",Health communication,['10.1080/10410236.2020.1802867']
272,32819048,Comparison between two different concentrations of a fixed dose of ropivacaine in interscalene brachial plexus block for pain management after arthroscopic shoulder surgery: a randomized clinical trial.,"BACKGROUND


Only a few studies have evaluated the differences between varying concentrations of a fixed dose of local anesthetics. This study was conducted to compare the effects of two different concentrations of a fixed dose of ropivacaine used in ultrasound-guided interscalene brachial plexus block.
METHODS


This prospective, randomized, double-blind study included 62 patients who underwent arthroscopic surgery under general anesthesia. The patients were randomly assigned to receive ultrasound-guided interscalene block with 75 mg of ropivacaine at one of two concentrations: 0.75% (10 ml; group C) or 0.375% (20 ml; group V). Time to onset of sensory blockade, degree of blockade, pulmonary function changes, analgesic duration of the interscalene block, postoperative opioid requirement within 24 h, postoperative pain scores, satisfaction, and incidence of complications were recorded.
RESULTS


Although the time to onset of sensory blockade was shorter for group C (P = 0.015), successful blockade was achieved at 30 min after the interscalene block in both groups. The analgesic duration of the interscalene block was not significantly different between the groups. The amount of opioid used within 24 h after surgery was significantly reduced for group V compared with group C (P = 0.016). The rest of the parameters did not show any significant differences between the two groups.
CONCLUSION


Compared with 10 ml of 0.75% ropivacaine, interscalene block with 20 ml of 0.375% ropivacaine could be effective for the reduction of postoperative opioid requirement within 24 h after surgery despite it might not prolong the analgesic duration.",2021,"Although the time to onset of sensory blockade was shorter for group C (P = 0.015), successful blockade was achieved at 30 min after the interscalene block in both groups.","['pain management after arthroscopic shoulder surgery', '62 patients who underwent arthroscopic surgery under general anesthesia']","['ultrasound-guided interscalene block with 75 mg of ropivacaine', 'ropivacaine', 'interscalene brachial plexus block', 'ultrasound-guided interscalene brachial plexus block']","['successful blockade', 'Time to onset of sensory and motor blockade, degree of motor and sensory blockade, pulmonary function changes, analgesic duration of the interscalene block, postoperative opioid requirement within 24 hours, postoperative pain scores, satisfaction score related to pain control, and incidence of complications', 'postoperative opioid requirement', 'analgesic duration of interscalene block', 'analgesic duration of the interscalene block', 'time to onset of sensory blockade']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",62.0,0.190894,"Although the time to onset of sensory blockade was shorter for group C (P = 0.015), successful blockade was achieved at 30 min after the interscalene block in both groups.","[{'ForeName': 'Seung Cheol', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Joon Ho', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Seong Yeop', 'Initials': 'SY', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sung Wan', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Chan Jong', 'Initials': 'CJ', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'So Ron', 'Initials': 'SR', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jeong Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sang Yoong', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}]",Korean journal of anesthesiology,['10.4097/kja.20353']
273,32822887,"Efficacy and Safety of Low-Molecular-Weight Heparin on Prevention of Venous Thromboembolism after Laparoscopic Operation for Gastrointestinal Malignancy in Japanese Patients: A Multicenter, Open-Label, Prospective, Randomized Controlled Trial.","BACKGROUND


The risk of venous thromboembolism (VTE) after surgery for malignancy in Japanese patients is unclear; therefore, standard prevention protocols have not been established, especially for minimally invasive procedures. We aimed to investigate the additional effect of low molecular weight heparin (LMWH) on prevention of VTE after laparoscopic surgery for gastrointestinal malignancy.
STUDY DESIGN


From February 2013 to January 2017, 400 patients scheduled for laparoscopic surgery were included. Cases were randomly allocated to the physical therapy group (Control group; 201 patients) or to the combination-therapy group (LMWH group; 199 patients), in which enoxaparin sodium (20 mg [= 2000 IU] twice a day) was administered for 1 week postoperatively in addition to the physical therapy. A diagnosis of VTE was made by contrast-enhanced CT or ultrasonography when symptomatic or D-dimer was ≥10 μg/mL.
RESULTS


VTE was observed in 1.2% and 4.0% of patients in the LMWH and Control groups, respectively (odds ratio [OR] 0.3, 95% confidence interval [CI] 0.03-1.53). Pulmonary embolism was confirmed only in the Control group (1.7%). No major bleeding occurred in either group. Logistic multiple regression analysis revealed that surgical time extension (OR 1.02, 95% CI 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR 0.21, 95% CI 0.03-0.99), male sex (OR 0.12, 95% CI 0.01-0.60), and early cancer (OR 0.17, 95% CI 0.02-0.82) reduced the risk of VTE.
CONCLUSIONS


Postoperative LMWH administration is safe. The additional effect of LMWH administration on the physical therapy was not statistically proven in this study. However, it could be useful for the patients with risk factors such as female sex, long operation time, and higher cancer stage.",2020,"Logistic multiple regression analysis revealed that surgical time extension (OR=1.02, 95%CI: 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR=0.21, 95%CI: 0.03-0.99), male sex (OR=0.12, 95%CI: 0.01-0.60), and early cancer (OR=0.17, 95%CI: 0.02-0.82) reduced the risk of VTE.
","['Japanese Patients', 'From February 2013 to January 2017, Four hundred patients scheduled for laparoscopic surgery were included', 'Japanese patients']","['LMWH', 'Low-Molecular-Weight Heparin', 'low-molecular-weight heparin (LMWH', 'physical therapy group (Control group; 201 patients) or to the combination-therapy group (LMWH group; 199 patients) in which enoxaparin sodium', 'Laparoscopic Operation']","['Pulmonary embolism', 'VTE', 'surgical time extension', 'major bleeding', 'risk of VTE', 'Venous Thromboembolism']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0724579', 'cui_str': 'Enoxaparin sodium'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",400.0,0.0725743,"Logistic multiple regression analysis revealed that surgical time extension (OR=1.02, 95%CI: 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR=0.21, 95%CI: 0.03-0.99), male sex (OR=0.12, 95%CI: 0.01-0.60), and early cancer (OR=0.17, 95%CI: 0.02-0.82) reduced the risk of VTE.
","[{'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Obitsu', 'Affiliation': 'Departments of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Oyama', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, Sendai, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Department of Surgery, South Miyagi Medical Center, Shibata-gun, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Departments of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics Tohoku University Graduate School of Medicine, Sendai, Japan; Clinical Research Data Center, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Airi', 'Initials': 'A', 'LastName': 'Takagi', 'Affiliation': 'Clinical Research Data Center, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Rikiyama', 'Affiliation': 'Departments of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Unno', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Naitoh', 'Affiliation': 'Department of Lower Gastrointestinal Surgery, Kitasato University School of Medicine, Sagamihara, Japan. Electronic address: naitot@med.kitasato-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.08.734']
274,32829027,"Suprachoroidal CLS-TA plus Intravitreal Aflibercept for Diabetic Macular Edema: A Randomized, Double-Masked, Parallel-Design, Controlled Study.","PURPOSE


This study evaluated the potential safety, efficacy, and durability advantages of investigational triamcinolone acetonide suspension (CLS-TA; Clearside Biomedical, Alpharetta, GA) administered suprachoroidally in conjunction with intravitreal aflibercept compared with aflibercept monotherapy for treatment of diabetic macular edema (DME).
DESIGN


TYBEE was a prospective, controlled, double-masked study. Patients were randomized 1:1 to CLS-TA and aflibercept (active) or aflibercept monotherapy (control), and assessed over 24 weeks.
PARTICIPANTS


Treatment-naive DME patients with best-corrected visual acuity (BCVA) of 20 to 70 letters and central subfield retinal thickness (CST) of more than 300 μm.
METHODS


Patients in the active group (n = 36) received CLS-TA and aflibercept at baseline and week 12. Patients in the control group (n = 35) received aflibercept at baseline, week 4, week 8, and week 12. To mask both groups, sham suprachoroidal and intravitreal injections were utilized. All patients were eligible to receive aflibercept as needed at weeks 4, 8, 16, and 20 per prespecified criteria.
MAIN OUTCOME MEASURE


Mean change in BCVA from baseline. Treatment differences were assessed with a 2-sided significance level of 0.10.
RESULTS


Mean BCVA changes from baseline to week 24 were not statistically different in the active and control groups (intention-to-treat [ITT] population: +11.4 letters and +13.8 letters [P = 0.288]; per protocol [PP] population: +12.3 letters and +13.5 letters [P = 0.664]; respectively). Greater improvement in CST was seen in the active versus control group (ITT population: -212.1 μm and -178.6 μm [P = 0.089]; PP population: -226.5 μm and -176.1 μm [P = 0.035]; respectively). Compared with the control group, eyes in the active group received fewer treatments (scheduled plus as-needed treatments averaging 4.6 versus 2.6, respectively). No treatment-related serious adverse events were observed. Ocular adverse events were low for both arms. Cataract events, all assessed as unrelated to treatment, and events of elevated intraocular pressure trended higher in the active group.
CONCLUSIONS


CLS-TA administered suprachoroidally in conjunction with intravitreal aflibercept for treatment of DME provides simliar visual benefit at 24 weeks' follow-up compared with aflibercept monotherapy, is well tolerated and shows modest anatomic benefit with potential to reduce treatment burden.",2021,"Mean changes from baseline in BCVA at week 24 were not statistically different in the Active and Control groups (+11.4 and +13.8 letters, p=0.288, intention to treat (ITT); +12.3 and +13.5 letters, p=0.664, per protocol (PP) populations, respectively).","['Diabetic Macular Edema', 'Treatment-naïve DME subjects with Best Corrected Visual Acuity (BCVA) 20-70 letters and central subfield retinal thickness (CST) > 300 μm', 'Subjects in the Active group (n=36) received', 'Diabetic Macular Edema (DME']","['Aflibercept With or Without Suprachoroidal CLS-TA', ""CLS-TA in conjunction with aflibercept ('Active') or aflibercept monotherapy ('Control"", 'aflibercept', 'aflibercept monotherapy', 'CLS-TA in conjunction with aflibercept', 'intravitreal aflibercept', 'CLS-TA']","['BCVA', 'Ocular adverse events', 'CST', 'Elevated IOP and cataract events', 'Mean change in BCVA']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0006790', 'cui_str': 'Calusterone'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.115216,"Mean changes from baseline in BCVA at week 24 were not statistically different in the Active and Control groups (+11.4 and +13.8 letters, p=0.288, intention to treat (ITT); +12.3 and +13.5 letters, p=0.664, per protocol (PP) populations, respectively).","[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Barakat', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona. Electronic address: mark.barakat@gmail.com.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas; Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Gonzalez', 'Affiliation': 'Valley Retina Institute, McAllen, Texas.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'Cumberland Valley Retina Consultants, Hagerstown, Maryland.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Marcus', 'Affiliation': 'Southeast Retina Center, PC, Augusta, Georgia.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zavaleta', 'Affiliation': 'West Texas Retina Consultants, LLC, Abilene, Texas; Retina Research Institute of Texas, Abilene, Texas.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Ciulla', 'Affiliation': 'Clearside Biomedical, Inc., Alpharetta, Georgia.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.08.007']
275,32851644,"The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving ≥50%, ≥75%, and 100% Response.","OBJECTIVE


To assess the efficacy of erenumab at the ≥50%, ≥75%, and 100% reduction in monthly migraine days (MMD) response thresholds, using data from the 6-month double-blind treatment phase (DBTP) of the Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention (STRIVE) pivotal clinical trial.
METHODS


Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days) were randomized (1:1:1) to erenumab 70 mg (n = 312), erenumab 140 mg (n = 318), or placebo (n = 316) once monthly. We determined the proportions of patients with ≥50%, ≥75% and 100% reduction in MMD over the last 3 months of the STRIVE DBTP (months 4 through 6) and conducted post hoc analyses to contextualize the treatment benefit in patient subgroups achieving, and not achieving, these response thresholds. Outcome measures included changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes.
RESULTS


The proportions of patients with a reduction in MMD from baseline were greater for erenumab than for placebo at all response thresholds. As previously reported for the ≥50% response threshold, 135/312 (43.3%) of patients on erenumab 70 mg and 159/318 (50.0%) on erenumab 140 mg responded, vs 84/316 (26.6%) for placebo. At months 4 through 6, 65/312 (20.8%) and 70/318 (22.0%) of those on erenumab 70 mg and erenumab 140 mg, respectively, achieved ≥75% reductions vs 25/316 (7.9%) on placebo. A reduction of 100% response, which required no migraine days over 3 consecutive months based on observed data, was achieved by 10/312 (3.2%) of patients treated with erenumab 70 mg and 16/318 (5.0%) for erenumab 140 mg, vs 9/316 (2.8%) for placebo. At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early. Meanwhile, 60/312 (19.2%) and 53/318 (16.7%) patients on erenumab 70 and 140 mg, respectively, had no reduction in MMD from baseline in months 4 through 6, compared with 104/316 (32.9%) patients on placebo.
CONCLUSIONS


The responses at the ≥50%, ≥75%, and 100% thresholds provide context for establishing realistic patient and physician expectations regarding the magnitude of treatment benefit that may be achieved by patients with EM responding to erenumab (STRIVE, NCT02456740).",2020,"At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early.","['Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days', 'Patients']","['placebo', 'Migraine Prevention', 'erenumab 70\xa0mg (n\xa0=\xa0312), erenumab 140\xa0mg (n\xa0=\xa0318), or placebo']","['mean MMD and MSMD', 'disability', 'changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes', 'MMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.137358,"At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early.","[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Broessner', 'Affiliation': 'Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jo H', 'Initials': 'JH', 'LastName': 'Bonner', 'Affiliation': 'Mercy Clinic Neurology and Headache Centre, Saint Louis, MO, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Hallström', 'Affiliation': 'Neuro Center, St Görans Hospital, Stockholm, Sweden.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Lenz', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Headache,['10.1111/head.13929']
276,32852294,"Comparison of Chloroprocaine Versus Lidocaine With Epinephrine, Sodium Bicarbonate, and Fentanyl for Epidural Extension Anesthesia in Elective Cesarean Delivery: A Randomized, Triple-Blind, Noninferiority Study.","BACKGROUND


For emergent intrapartum cesarean delivery (CD), the literature does not support the use of any particular local anesthetic solution to extend epidural analgesia to cesarean anesthesia. We hypothesized that 3% chloroprocaine (CP) would be noninferior to a mixture of 2% lidocaine, 150 µg of epinephrine, 2 mL of 8.4% bicarbonate, and 100 µg of fentanyl (LEBF) in terms of onset time to surgical anesthesia.
METHODS


In this single-center randomized noninferiority trial, adult healthy women undergoing CD were randomly assigned to epidural anesthesia with either CP or LEBF. Sensory blockade (pinprick) to T10 was established before operating room (OR) entry for elective CD. On arrival to the OR, participants received the epidural study medications in a standardized manner to simulate the conversion of ""epidural labor analgesia to surgical anesthesia."" The primary outcome was the time to loss of touch sensation at the T7 level. A noninferiority margin was set at 3 minutes. The secondary outcome was the need for intraoperative analgesia supplementation.
RESULTS


In total, 70 women were enrolled in the study. The mean onset time to achieve a bilateral sensory block to touch at the T7 dermatome level was 655 (standard deviation [SD] = 258) seconds for group CP and 558 (269) seconds for group LEBF, a difference in means of 97 seconds (90% confidence interval [CI], SD = -10.6 to 204; P = .10 for noninferiority). The upper limit of the 90% CI for the mean difference exceeded the prespecified 3-minute noninferiority margin. There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
CONCLUSION


Both anesthetic solutions have a rapid onset of anesthesia when used to extend low-dose epidural sensory block to surgical anesthesia. Data from the current study provide insufficient evidence to confirm that CP is noninferior to LEBF for rapid epidural extension anesthesia for CD, and further research is required to determine noninferiority.",2021,"There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
","['70 women were enrolled in the study', 'adult healthy women undergoing CD', 'Epidural Extension Anesthesia in Elective Cesarean Delivery']","['epinephrine, 2 mL of 8.4% bicarbonate, and 100 µg of fentanyl (LEBF', 'epidural anesthesia with either CP or LEBF', 'LEBF', 'Epinephrine, Sodium Bicarbonate, and Fentanyl', 'Chloroprocaine', 'chloroprocaine (CP', 'Lidocaine', 'lidocaine']","['mean onset time to achieve a bilateral sensory block to touch at the T7 dermatome level', 'time to loss of touch sensation at the T7 level', 'intraoperative analgesia', 'need for intraoperative analgesia supplementation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0055443', 'cui_str': 'chloroprocaine'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0448760', 'cui_str': 'Dermatome of seventh thoracic nerve'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0702221', 'cui_str': 'Touch sensation, function'}, {'cui': 'C0446425', 'cui_str': 'Level of the seventh thoracic vertebra'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",70.0,0.19062,"There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
","[{'ForeName': 'Nadir', 'Initials': 'N', 'LastName': 'Sharawi', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Prannal', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Horace', 'Initials': 'H', 'LastName': 'Spencer', 'Affiliation': 'Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Mhyre', 'Affiliation': 'From the Departments of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005141']
277,32853634,Relationship Between Combined Histologic and Endoscopic Endpoints and Efficacy of Ustekinumab Treatment in Patients With Ulcerative Colitis.,"BACKGROUND & AIMS


Ustekinumab induces and maintains histologic improvement in patients with ulcerative colitis (UC). The clinical relevance of this endpoint alone, and in combination with endoscopic improvement, is unknown.
METHODS


Histologic disease activity was evaluated in 2630 colonic biopsy samples from patients with UC treated in the UNIFI phase 3 UC clinical studies of ustekinumab. We evaluated associations between histologic improvement (defined as the composite of neutrophil infiltration in less than 5% of crypts and no crypt destruction, erosions, ulcerations, or granulation tissue) and clinical endpoints at the end of induction (week 8 and 16) and maintenance (week 44) periods. We assessed the validity of a combined histologic and endoscopic (Mayo endoscopy subscore, 0 or 1) improvement endpoint, which we called histo-endoscopic mucosal healing (or histo-endoscopic mucosal improvement).
RESULTS


Histologic improvement was significantly (P < .0001) associated with clinical remission, lower mean disease activity scores, and greater improvement in disease activity at the end of induction and maintenance studies. Ustekinumab induced and maintained significantly higher rates of histologic improvement at induction week 8 and maintenance week 44 than placebo when more stringent definitions of histologic improvement were used. Histologic improvement and endoscopic improvement following induction were associated with 10% to 20% higher rates of histo-endoscopic mucosal healing, clinical remission, and corticosteroid-free remission at week 44 (all P < .05) in patients who received ustekinumab maintenance therapy. At week 44, 61% of patients (56/92) with histo-endoscopic mucosal healing after induction therapy achieved clinical remission, versus 39% of patients (9/23, P = .0983) and 34% of patients (24/71, P = .0009) with endoscopic or histologic improvement alone after induction, respectively.
CONCLUSION


Data from the UNIFI program of ustekinumab in patients with UC treated with ustekinumab indicated the achievement of histo-endoscopic mucosal healing after induction therapy is associated with lower disease activity at the end of maintenance therapy than either histologic or endoscopic improvement alone. ClinicalTrials.gov number: NCT02407236.",2020,Ustekinumab induced and maintained significantly higher rates of histologic improvement at induction week 8 and maintenance week 44 than placebo when more stringent definitions of histologic improvement were used.,"['Patients With Ulcerative Colitis', 'patients with ulcerative colitis (UC', '2630 colonic biopsy samples from patients with UC treated in the UNIFI phase 3 UC clinical studies of ustekinumab']","['Ustekinumab Treatment', 'ustekinumab maintenance therapy', 'placebo']","['disease activity', 'rates of histologic improvement', 'achievement of histo-endoscopic mucosal healing', 'clinical remission', 'clinical remission, lower mean disease activity scores', 'validity of a combined histologic and endoscopic (Mayo endoscopy subscore, 0 or 1) improvement endpoint which we called histo-endoscopic mucosal healing (or histo-endoscopic mucosal improvement', 'crypt destruction, erosions, ulcerations, or granulation tissue) and clinical endpoints', 'histo-endoscopic mucosal healing, clinical remission, and corticosteroid-free remission', 'Histologic improvement', 'Histologic improvement and endoscopic improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0586716', 'cui_str': 'Colonic biopsy sample'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",2630.0,0.0468271,Ustekinumab induced and maintained significantly higher rates of histologic improvement at induction week 8 and maintenance week 44 than placebo when more stringent definitions of histologic improvement were used.,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Immunology Translational Science, Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Immunology Translational Science, Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Rubin', 'Affiliation': 'Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Gastroenterology Department and Inserm U1256 Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Friedman', 'Affiliation': 'Immunology Translational Science, Janssen Research & Development, LLC, Spring House, Pennsylvania. Electronic address: joshfriedman@me.com.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'De Hertogh', 'Affiliation': 'Deparment of Pathology, University Hospitals KU Leuven, Belgium. Electronic address: gert.dehertogh@uzleuven.be.'}]",Gastroenterology,['10.1053/j.gastro.2020.08.037']
278,32853647,Effect of long-term testosterone therapy on molecular regulators of skeletal muscle mass and fibre-type distribution in aging men with subnormal testosterone.,"BACKGROUND


Long-term testosterone replacement therapy (TRT) increases muscle mass in elderly men with subnormal testosterone levels. However, the molecular mechanisms underlying this effect of TRT on protein balance in human skeletal muscle in vivo remain to be established.
METHODS


Here, we examined skeletal muscle biopsies obtained before and 24-h after the last dose of treatment with either testosterone gel (n = 12) or placebo (n = 13) for 6 months in aging men with subnormal bioavailable testosterone levels. The placebo-controlled, testosterone-induced changes (β-coefficients) in mRNA levels, protein expression and phosphorylation were examined by quantitative real-time PCR and western blotting.
RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors. However, TRT caused a sustained decrease in protein expression of SMAD2 (β = -36%, p = 0.004) and SMAD3 (β = -32%, p = 0.001), which was accompanied by reduced protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1 (β = -26%, p = 0.004) and Atrogin-1/MAFbx (β = -20%, p = 0.04), but with no changes in FOXO3 signalling. Importantly, TRT did not affect muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres.
CONCLUSIONS


Our results indicate that long-term TRT of elderly men with subnormal testosterone levels increases muscle mass, at least in part, by decreasing protein breakdown through the ubiquitin proteasome pathway mediated by a sustained suppression of SMAD-signalling and muscle-specific E3-ubiquitin ligases.",2020,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","['aging men with subnormal testosterone', 'elderly men with subnormal testosterone levels']","['testosterone replacement therapy (TRT', 'long-term testosterone therapy', 'placebo', 'testosterone gel', 'TRT']","['muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres', 'protein expression of SMAD2', 'Atrogin-1/MAFbx', 'muscle mass', 'skeletal muscle mass and fibre-type distribution', 'protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1', 'mRNA levels, protein expression and phosphorylation', 'mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1566790', 'cui_str': 'SMAD2 protein, human'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0041538', 'cui_str': 'Ubiquitin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0050668', 'cui_str': 'Activin hormone'}, {'cui': 'C0076925', 'cui_str': 'USF Transcription Factors'}]",,0.0809258,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","[{'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Kruse', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Stine J', 'Initials': 'SJ', 'LastName': 'Petersson', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Louise L', 'Initials': 'LL', 'LastName': 'Christensen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Kristensen', 'Affiliation': 'Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark; Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-2100 Copenhagen, Denmark.'}, {'ForeName': 'Rugivan', 'Initials': 'R', 'LastName': 'Sabaratnam', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Ørtenblad', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, DK-5230 Odense, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Højlund', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark. Electronic address: kurt.hoejlund@rsyd.dk.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154347']
279,32845997,A Randomized Controlled Trial of Intravenous N-Acetylcysteine in the Management of Anti-tuberculosis Drug-Induced Liver Injury.,"BACKGROUND


Liver injury is a common complication of anti-tuberculosis therapy. N-acetylcysteine (NAC) used in patients with paracetamol toxicity with limited evidence of benefit in liver injury due to other causes.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial to assess the efficacy of intravenous NAC in hospitalized adult patients with anti-tuberculosis drug-induced liver injury (AT-DILI). The primary endpoint was time for serum alanine aminotransferase (ALT) to fall below 100 U/L. Secondary endpoints included length of hospital stay, in-hospital mortality, and adverse events.
RESULTS


Fifty-three participants were randomized to NAC and 49 to placebo. Mean age was 38 (SD±10) years, 58 (57%) were female, 89 (87%) were HIV positive. Median (IQR) serum ALT and bilirubin at presentation were 462 (266-790) U/L and 56 (25-100) μmol/L, respectively. Median time to ALT <100 U/L was 7.5 (6-11) days in the NAC arm and 8 (5-13) days in the placebo arm. Median time to hospital discharge was shorter in the NAC arm (9 [6-15] days) than in the placebo arm (18 [10-25] days) (HR, 1.73; 95% CI, 1.13-2.65). Mortality was 14% overall and did not differ by study arm. The study infusion was stopped early due to an adverse reaction in 5 participants receiving NAC (nausea and vomiting [3], anaphylaxis [1], pain at drip site [1]).
CONCLUSIONS


NAC did not shorten time to ALT <100 U/L in participants with AT-DILI, but significantly reduced length of hospital stay. NAC should be considered in management of AT-DILI.
CLINICAL TRIALS REGISTRATION


South African National Clinical Trials Registry (SANCTR: DOH-27-0414-4719).",2021,NAC did not shorten time to ALT&100,"['5 participants receiving NAC [nausea and vomiting (3), anaphylaxis (1), pain at drip site (1', 'Fifty-three participants', 'hospitalized adult patients with anti-tuberculosis drug induced liver injury (AT-DILI', 'Mean age was 38 (SD±10) years, 58 (57%) were female and 89 (87%) were HIV-positive', 'Anti-tuberculosis Drug-Induced Liver Injury']","['intravenous NAC', 'ALT&100', 'placebo', 'NAC', 'Intravenous N-acetylcysteine', 'N-acetylcysteine (NAC']","['Mortality', 'length of hospital stay, in-hospital mortality and adverse events', 'Median serum ALT and total bilirubin', 'time for serum alanine aminotransferase (ALT', 'Median time to hospital discharge', 'length of hospital stay', 'Median time to ALT&100']","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0452837', 'cui_str': 'Dripping'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0860207', 'cui_str': 'Drug-induced disorder of liver'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",53.0,0.726472,NAC did not shorten time to ALT&100,"[{'ForeName': 'Muhammed Shiraz', 'Initials': 'MS', 'LastName': 'Moosa', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Gunter', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Shaazia', 'Initials': 'S', 'LastName': 'Allie', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Chughlay', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mashiko', 'Initials': 'M', 'LastName': 'Setshedi', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Wasserman', 'Affiliation': 'Division of Infectious Diseases and HIV Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Stead', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hickman', 'Affiliation': 'Clinical Research Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Annemie', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Clinical Research Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sonderup', 'Affiliation': 'Division of Hepatology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Catherine Wendy', 'Initials': 'CW', 'LastName': 'Spearman', 'Affiliation': 'Division of Hepatology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cohen', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1255']
280,32856272,Single versus dual blockade of the renin-angiotensin system in patients with IgA nephropathy.,"BACKGROUND


Inhibitors of the renin-angiotensin system (RAS) are cornerstones of supportive therapy in patients with IgA nephropathy (IgAN). We analyzed the effects of single versus dual RAS blockaQueryde during our randomized STOP-IgAN trial.
METHODS


STOP-IgAN participants with available successive information on their RAS treatment regimen and renal outcomes during the randomized 3-year trial phase were stratified post hoc into two groups, i.e. patients under continuous single or dual RAS blocker therapy over the entire 3 years of the trial phase. Primary and secondary STOP-IgAN trial endpoints, i.e. frequencies of full clinical remission, eGFR-loss ≥ 15 and ≥ 30 ml/min/1.73 m 2  and ESRD onset, were analyzed by logistic regression and linear mixed effects models.
RESULTS


Among the 112 patients included in the present analysis, 82 (73%) were maintained on single and 30 (27%) on dual RAS inhibitor therapy throughout the trial. Neither RAS blocker strategy significantly affected full clinical remission, eGFR-loss rates, onset of ESRD. Proteinuria moderately increased in patients under dual RAS blockade by 0.1 g/g creatinine during the 3-year trial phase. This was particularly evident in patients without additional immunosuppression during the randomized trial phase, where proteinuria increased by 0.2 g/g creatinine in the dual RAS blockade group. In contrast, proteinuria decreased in patients under single RAS blocker therapy by 0.3 g/g creatinine. The course of eGFR remained stable and did not differ between the RAS treatment strategies.
CONCLUSION


In the STOP-IgAN cohort, neither RAS blocker regimen altered renal outcomes. Patients on dual RAS blockade even exhibited higher proteinuria over the 3-year trial phase.",2020,Proteinuria moderately increased in patients under dual RAS blockade by 0.1 g/g creatinine during the 3-year trial phase.,"['patients with IgA nephropathy (IgAN', 'STOP-IgAN participants with available successive information on their RAS treatment regimen and renal outcomes during the randomized 3-year trial phase were stratified post hoc into two groups, i.e. patients under', '112 patients included in the present analysis, 82 (73%) were maintained on single and 30 (27%) on dual RAS inhibitor therapy throughout the trial', 'patients with IgA nephropathy']","['renin-angiotensin system', 'renin-angiotensin system (RAS', 'dual RAS blockade', 'continuous single or dual RAS blocker therapy', 'RAS blocker']","['frequencies of full clinical remission, eGFR-loss\u2009≥\u200915 and\u2009≥', 'renal outcomes', 'full clinical remission, eGFR-loss rates, onset of ESRD', 'Proteinuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",112.0,0.114681,Proteinuria moderately increased in patients under dual RAS blockade by 0.1 g/g creatinine during the 3-year trial phase.,"[{'ForeName': 'David Paul', 'Initials': 'DP', 'LastName': 'Lennartz', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Seikrit', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wied', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fitzner', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Eitner', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hilgers', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rauen', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Floege', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany. jfloege@ukaachen.de.'}]",Journal of nephrology,['10.1007/s40620-020-00836-8']
281,32877521,Swab-yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 1. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Clinician-taken vs Self-taken Rectal and Pharyngeal Samples for the Diagnosis of Gonorrhea and Chlamydia.,"BACKGROUND


Urogenital testing misses extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). Extragenital self-sampling is frequently undertaken despite no robust randomized, controlled trial evidence of efficacy. We compared clinician-taken rectal and pharyngeal samples with self-taken samples for diagnostic accuracy and cost in men who have sex with men (MSM) and in females.
METHODS


This was a prospective convenience sample from a UK sexual health clinic. We randomized the order of clinician- and self-taken samples from the pharynx and rectum, plus first catch urine (MSM) and vulvovaginal swabs (females), for NG/CT detection.
RESULTS


Of 1793 participants (1284 females, 509 MSM), 116 had NG detected (75 urogenital, 83 rectum, 72 pharynx); 9.4% infected females and 67.3% MSM were urogenital-negative. A total of 276 had CT detected (217 urogenital, 249 rectum, 63 pharynx); 13.1% infected females and 71.8% MSM were urogenital-negative. Sexual history did not identify those with rectal infections. There was no difference in diagnostic accuracy between clinician- and self-taken samples from the rectum or pharynx. Clinicians took swabs more quickly than participants, so costs were lower. However, in asymptomatic people, nonqualified clinicians would oversee self-swabbing making these costs lower.
CONCLUSIONS


There was no difference in the diagnostic accuracy of clinician-taken compared with self-taken extragenital samples. Sexual history did not identify those with rectal infections, so individuals should have extragenital clinician- or self-taken samples. Clinician-taken swabs cost less than self-taken swabs; however, in asymptomatic people or those who perform home testing, the costs would be lower than for clinician-taken swabs.
CLINICAL TRIALS REGISTRATION


NCT02371109.",2021,"Clinician-rectal and self-rectal positive percent agreements (PPA) for NG detection were 92.8% and 97.6%; clinician-rectal, and self-rectal PPA for CT detection were 95.6% and 97.2%.","['Prospective, convenience, sample in UK sexual health clinic', '276 had CT detected (217 urogenital site, 249 rectum, 63 pharynx); 13.1% infected females and 71.8% MSM were urogenital negative', '1793 participants (1284 females, 509 MSM']",['clinician-taken versus self-taken rectal and pharyngeal samples'],"['diagnostic accuracy', 'diagnostic accuracy of clinician', 'Clinician-rectal and self-rectal positive percent agreements (PPA) for NG detection']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0027573', 'cui_str': 'Neisseria gonorrhoeae'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",1793.0,0.0340571,"Clinician-rectal and self-rectal positive percent agreements (PPA) for NG detection were 92.8% and 97.6%; clinician-rectal, and self-rectal PPA for CT detection were 95.6% and 97.2%.","[{'ForeName': 'Janet D', 'Initials': 'JD', 'LastName': 'Wilson', 'Affiliation': 'Leeds Sexual Health, Leeds Teaching Hospitals National Health Service Trust, Leeds, United Kingdom.'}, {'ForeName': 'Harriet E', 'Initials': 'HE', 'LastName': 'Wallace', 'Affiliation': 'Leeds Sexual Health, Leeds Teaching Hospitals National Health Service Trust, Leeds, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Loftus-Keeling', 'Affiliation': 'Leeds Sexual Health, Leeds Teaching Hospitals National Health Service Trust, Leeds, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ward', 'Affiliation': 'Department of Infectious Disease Epidemiology, Imperial College, London, United Kingdom.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Davies', 'Affiliation': 'Department of Epidemiology and Biostatistics, Imperial College, London, United Kingdom.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Vargas-Palacios', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Department of Clinical Microbiology, Leeds Teaching Hospitals National Health Service Trust, Leeds, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1266']
282,32873572,Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma.,"PURPOSE


Patients with advanced renal cell carcinoma with sarcomatoid features (sRCC) have poor prognoses and suboptimal outcomes with targeted therapy. This  post hoc  analysis of the phase III CheckMate 214 trial analyzed the efficacy of nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib in patients with sRCC.
PATIENTS AND METHODS


Patients with sRCC were identified via independent central pathology review of archival tumor tissue or histologic classification per local pathology report. Patients were randomized 1:1 to receive nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks (four doses) then nivolumab 3 mg/kg every 2 weeks, or sunitinib 50 mg orally every day (4 weeks; 6-week cycles). Outcomes in patients with sRCC were not prespecified. Endpoints in patients with sRCC and International Metastatic Renal Cell Carcinoma Database Consortium intermediate/poor-risk disease included overall survival (OS), progression-free survival (PFS) per independent radiology review, and objective response rate (ORR) per RECIST v1.1. Safety outcomes used descriptive statistics.
RESULTS


Of 1,096 randomized patients in CheckMate 214, 139 patients with sRCC and intermediate/poor-risk disease and six with favorable-risk disease were identified. With 42 months' minimum follow-up in patients with sRCC and intermediate/poor-risk disease, median OS [95% confidence interval (CI)] favored NIVO+IPI [not reached (NR) (25.2-not estimable [NE]);  n  = 74] versus sunitinib [14.2 months (9.3-22.9);  n  = 65; HR, 0.45 (95% CI, 0.3-0.7;  P  = 0.0004)]; PFS benefits with NIVO+IPI were similarly observed [median 26.5 vs. 5.1 months; HR, 0.54 (95% CI, 0.33-0.86;  P  = 0.0093)]. Confirmed ORR was 60.8% with NIVO+IPI versus 23.1% with sunitinib, with complete response rates of 18.9% versus 3.1%, respectively. No new safety signals emerged.
CONCLUSIONS


NIVO+IPI showed unprecedented long-term survival, response, and complete response benefits versus sunitinib in previously untreated patients with sRCC and intermediate/poor-risk disease, supporting the use of first-line NIVO+IPI for this population. See related commentary by Hwang et al., p. 5 .",2021,"CONCLUSIONS


NIVO+IPI showed unprecedented long-term survival, response and complete response benefits versus SUN in previously untreated patients with sRCC and intermediate/poor-risk disease, supporting the use of first-line NIVO+IPI for this population.","['patients with sRCC', 'Patients with Advanced Sarcomatoid Renal Cell Carcinoma', 'patients with sRCC and IMDC intermediate/poor-risk disease included', '139 patients with sRCC and intermediate/poor-risk disease and six with favorable-risk disease', 'Patients with advanced renal cell carcinoma with sarcomatoid features (sRCC', '1096 randomized patients in CheckMate 214', 'Patients with sRCC were identified via independent central pathology review of archival tumor tissue or histological classification per local pathology report']","['Nivolumab Plus Ipilimumab', 'NIVO 3 mg/kg Q2W, or SUN 50 mg orally QD', 'nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib (SUN', 'NIVO (3 mg/kg) plus IPI']","['overall survival (OS), progression-free survival (PFS) per independent radiology review, and objective response rate (ORR', 'complete response rates', 'ORR', 'intermediate/poor-risk disease, median OS', 'Efficacy and Safety', 'long-term survival, response and complete response benefits versus SUN', 'PFS benefits with NIVO+IPI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1266043', 'cui_str': 'Renal cell carcinoma, sarcomatoid'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0807321', 'cui_str': 'Pathology report'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1696717', 'cui_str': 'sunitinib 50 MG [Sutent]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0668760', 'cui_str': 'diinosine pentaphosphate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]",1096.0,0.0627441,"CONCLUSIONS


NIVO+IPI showed unprecedented long-term survival, response and complete response benefits versus SUN in previously untreated patients with sRCC and intermediate/poor-risk disease, supporting the use of first-line NIVO+IPI for this population.","[{'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas. ntannir@mdanderson.org.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Signoretti', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Division of Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Abdallah', 'Initials': 'A', 'LastName': 'Flaifel', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Pignon', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ficial', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Osvaldo Arén', 'Initials': 'OA', 'LastName': 'Frontera', 'Affiliation': 'Centro de Investigación Clínica Bradford Hill, Recoleta, Chile.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Urology, Barts Cancer Institute, Queen Mary University of London, Royal Free NHS Trust, London, United Kingdom.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Harrison', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthélémy', 'Affiliation': 'Medical Oncology Unit, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Tykodi', 'Affiliation': 'Department of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Kocsis', 'Affiliation': 'Oncology Department, Debrecen University Clinical Center, Debrecen, Hungary.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Department of Medical Oncology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Jeronimo R', 'Initials': 'JR', 'LastName': 'Rodriguez-Cid', 'Affiliation': 'Centro Oncológico, Hospital Médica Sur, Mexico City, Mexico.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, California.'}, {'ForeName': 'Andre M', 'Initials': 'AM', 'LastName': 'Murad', 'Affiliation': 'CENANTRON-PERSONAL-Precision Oncology, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Ishii', 'Affiliation': 'Department of Clinical Trials, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Shruti Shally', 'Initials': 'SS', 'LastName': 'Saggi', 'Affiliation': 'Department of Clinical Trials, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Department of Biostatistics, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Division of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2063']
283,32867541,The Impact of Educative News Articles about Suicide Prevention: A Randomized Controlled Trial.,"Media stories featuring stories of personal experiences of coping with suicidal ideation have been shown to decrease suicide risk, but it is unclear whether more impersonal awareness materials have similar effects. This study aimed to test the impact of impersonal educative news articles featuring interviews with suicide prevention experts. Because the impact of news articles may be determined by the articles' pull quotes and headlines, we also aimed to compare the impact of two versions of the same suicide prevention news article. One version featured headlines and pull quotes highlighting the message that suicide is preventable, whereas the other version focused on the message that suicide is prevalent. In a web-based randomized controlled trial,  n  = 425 participants either read a news article featuring a prevention expert with one of the above versions of the same text or an article unrelated to suicide. Data on suicidal ideation, stigmatizing attitudes toward suicidal individuals, policy attitudes toward suicide prevention, help-seeking intentions, and assumptions on the prevalence of suicide-related behavior were measured with questionnaires. The assumed prevalence of suicide in the population was greater in both intervention groups than in the control group, but the articles did not have an impact on other outcomes, and there were no differences for variations in headlines and pull quotes. Impersonal suicide prevention articles appear safe to use and do not have an impact on suicide risk factors in general population samples.",2021,Impersonal suicide prevention articles appear safe to use and do not have an impact on suicide risk factors in general population samples.,['n  =\xa0425 participants either read a news article featuring a prevention expert with one of the above versions of the same text or an article unrelated to suicide'],[],['prevalence of suicide'],"[{'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]",[],"[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]",425.0,0.0684609,Impersonal suicide prevention articles appear safe to use and do not have an impact on suicide risk factors in general population samples.,"[{'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Till', 'Affiliation': 'Unit Suicide Research and Mental Health Promotion, Department of Social and Preventive Medicine, Center for Public Health, Medical University of Vienna.'}, {'ForeName': 'Ulrich S', 'Initials': 'US', 'LastName': 'Tran', 'Affiliation': 'Wiener Werkstaette for Suicide Research.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Niederkrotenthaler', 'Affiliation': 'Unit Suicide Research and Mental Health Promotion, Department of Social and Preventive Medicine, Center for Public Health, Medical University of Vienna.'}]",Health communication,['10.1080/10410236.2020.1813953']
284,32863275,Cost-effectiveness of robotic hysterectomy versus abdominal hysterectomy in early endometrial cancer.,"OBJECTIVES


To compare total costs for hospital stay and post-operative recovery between robotic and abdominal hysterectomy in the treatment of early-stage endometrial cancer provided in an enhanced recovery after surgery (ERAS) setting. Costs were evaluated in relation to health impact, taking a societal perspective.
METHODS


Cost analysis was based on data from an open randomized controlled trial in an ERAS setting at a Swedish tertiary referral university hospital: 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included; 25 women were allocated to robotic and 25 to abdominal hysterectomy. We compared the total time in the operating theater, procedure costs, post-operative care, length of hospital stay, readmissions, informal care, and sick leave as well as the health-related quality of life until 6 weeks after surgery. The comparison was made by using the EuroQoL group form with five dimensions and three levels (EQ-5D). The primary outcome measure was total cost; secondary outcomes were quality-adjusted life-years (QALYs) and cost per QALY. The costs were calculated in Swedish Krona (SEK).
RESULTS


Age (median (IQR) 68 (63-72) vs 67 (59-75) years), duration of hospital stay (ie, time to discharge criteria were met) (median (IQR) 36 (36-36) vs 36 (36-54) hours), and sick leave (median (IQR) 25 (17-30) vs 31 (36-54) days) did not differ between the robotic and abdominal group. Time of surgery was significantly longer in the robotic group than in the abdominal group (median (IQR) 70 (60-90) vs 56 (49-84) min; p<0.05). The robotic group recovered significantly faster as measured by the EQ-5D health index and gained 0.018 QALYs until 6 weeks after surgery. Total costs were 20% higher for the robotic procedure (SEK71 634 vs SEK59 319). The total cost per QALY gained for women in the robotic group was slightly under SEK700 000.
CONCLUSIONS


Robotic hysterectomy used in an ERAS setting in the treatment of early endometrial cancer improved health within 6 weeks after the operation at a high cost for the health gained compared with abdominal hysterectomy. The productivity loss and informal care were lower for robotic hysterectomy, while healthcare had a higher procedure cost that could not be offset by the higher cost due to complications in the abdominal group.",2020,The robotic group recovered significantly faster as measured by the EQ-5D health index and gained 0.018 QALYs until 6 weeks after surgery.,"['ERAS setting at a Swedish tertiary referral university hospital: 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included; 25 women', 'early-stage endometrial cancer', 'early endometrial cancer']","['Robotic hysterectomy', 'robotic and 25 to abdominal hysterectomy', 'robotic hysterectomy versus abdominal hysterectomy', 'robotic and abdominal hysterectomy']","['Time of surgery', 'productivity loss and informal care', 'Total costs', 'EQ-5D health index', 'sick leave', 'duration of hospital stay ', 'total cost; secondary outcomes were quality-adjusted life-years (QALYs) and cost per QALY', 'total cost per QALY gained', 'total time in the operating theater, procedure costs, post-operative care, length of hospital stay, readmissions, informal care, and sick leave as well as the health-related quality of life']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C3494177', 'cui_str': 'Informal care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",25.0,0.184568,The robotic group recovered significantly faster as measured by the EQ-5D health index and gained 0.018 QALYs until 6 weeks after surgery.,"[{'ForeName': 'Evelyn Serreyn', 'Initials': 'ES', 'LastName': 'Lundin', 'Affiliation': 'Department of Obstetrics and Gynecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden evelyn.lundin@regionostergotland.se.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlsson', 'Affiliation': 'Division of Society and Health, Department of Health, Medicine and Caring Sciences, Linköpings Universitet, Linköping, Sweden.'}, {'ForeName': 'Ninnie Borendal', 'Initials': 'NB', 'LastName': 'Wodlin', 'Affiliation': 'Department of Obstetrics and Gynecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Nilsson', 'Affiliation': 'Department of Anesthesiology and Intensive Care in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden.'}, {'ForeName': 'Preben', 'Initials': 'P', 'LastName': 'Kjölhede', 'Affiliation': 'Department of Obstetrics and Gynecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001611']
285,32867560,Provider-adolescent discussion and provider education about asthma triggers during pediatric visits: results of a randomized trial.,"OBJECTIVE


We examined how an asthma question prompt list with video intervention influenced discussion of and provider education about asthma triggers.
METHODS


English or Spanish-speaking adolescents ages 11-17 with persistent asthma and their caregivers were enrolled from four pediatric clinics. Adolescents were randomized to the intervention or usual care groups. Adolescents in the intervention group watched the video on an iPad and then completed a one-page asthma question prompt list before their visits. All visits were audio-recorded. Generalized Estimating Equations were used to predict the number of trigger areas discussed and the number of areas providers educated adolescents about during visits.
RESULTS


Forty providers and 359 patients participated. Triggers were discussed during 89% of intervention group visits and 81% of usual care visits; providers educated adolescents about triggers during 59% of intervention group visits and 46% of usual care visits. More triggers were significantly more likely to be discussed and providers educated about more trigger areas during visits of adolescents in the intervention group and when adolescents asked one or more questions during visits. More trigger areas were significantly more likely to be discussed if the adolescent was White and male. Providers were significantly more likely to educate adolescents whose family spoke Spanish at home about more trigger areas than adolescents who spoke English at home.
CONCLUSIONS


More trigger areas were significantly more likely to be discussed and providers educated about more trigger areas during visits of adolescents who received the intervention and when adolescents asked one or more questions.",2021,Triggers were discussed during 89% of intervention group visits and 81% of usual care visits; providers educated adolescents about triggers during 59% of intervention group visits and 46% of usual care visits.,"['Pediatric Visits', 'Adolescents', 'Results:  Forty providers and 359 patients participated', 'English or Spanish-speaking adolescents ages 11-17 with persistent asthma and their caregivers were enrolled from four pediatric clinics']",['video intervention'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0288804,Triggers were discussed during 89% of intervention group visits and 81% of usual care visits; providers educated adolescents about triggers during 59% of intervention group visits and 46% of usual care visits.,"[{'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Sleath', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Delesha M', 'Initials': 'DM', 'LastName': 'Carpenter', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Davis', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Sayner', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Alexor LLC, Morrisville, NC, USA.'}, {'ForeName': 'Ceila E', 'Initials': 'CE', 'LastName': 'Loughlin', 'Affiliation': 'Department of Pediatric Pulmonology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Nacire', 'Initials': 'N', 'LastName': 'Garcia', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Reuland', 'Affiliation': 'Division of General Internal Medicine and Clinical Epidemiology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Tudor', 'Affiliation': 'Health Professions at Southern, New Hampshire University, Manchester, NH, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1817936']
286,32869419,Improved rates of treatment success following alcohol and other drug treatment among clients who quit or reduce their tobacco smoking.,"INTRODUCTION AND AIMS


Alcohol and other drug (AOD) treatment seekers who smoke tobacco are more likely to die of tobacco-related causes than those attributable to their primary drug of concern (PDOC), yet smoking cessation is frequently overlooked in the context of AOD treatment settings. We explored rates of AOD treatment success among participants who quit or continued smoking 12 months after initiating AOD treatment.
DESIGN AND METHODS


Secondary analysis of data from a prospective multisite naturalistic outcome study of 559 smokers recruited from 21 publicly funded specialist AOD services as part of the Patient Pathways National Project.
RESULTS


Only 7.1% of participants successfully quit smoking at 12-month follow-up; however, doing so was associated with a 30% increase in treatment success (i.e. reliable reductions in use of their PDOC) (χ 2  = 8.74, P = 0.003) and a 21% reduction in the severity of PDOC dependence (χ 2  = 4.559, P = 0.033). Furthermore, those who did not nominate tobacco as a drug of concern reported demographic characteristics indicative of greater social disadvantage.
DISCUSSION AND CONCLUSIONS


Despite low overall rates of smoking cessation, our findings suggest clients who do successfully quit have a greater likelihood of achieving reductions in PDOC use and dependence severity. These results reinforce efforts to promote more comprehensive, routine provision of smoking cessation care (i.e. counselling and nicotine replacement therapy). AOD treatment presents a crucial opportunity to deliver smoking cessation care to all clients who smoke, particularly those who are unconcerned about their use, as this group may stand to benefit most.",2021,"Despite low overall rates of smoking cessation, our findings suggest clients who do successfully quit have a greater likelihood of achieving reductions in PDOC use and dependence severity.","['559 smokers recruited from 21 publicly funded specialist AOD services as part of the Patient Pathways National Project', 'clients who quit or reduce their tobacco smoking', 'participants who quit or continued smoking 12\u2009months after initiating AOD treatment']",[],"['rates of AOD treatment success', 'severity of PDOC dependence', 'treatment success', 'quit smoking']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",559.0,0.0208004,"Despite low overall rates of smoking cessation, our findings suggest clients who do successfully quit have a greater likelihood of achieving reductions in PDOC use and dependence severity.","[{'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Piercy', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Joshua B B', 'Initials': 'JBB', 'LastName': 'Garfield', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Dan I', 'Initials': 'DI', 'LastName': 'Lubman', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Lam', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Manning', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}]",Drug and alcohol review,['10.1111/dar.13150']
287,32877244,Prospective Evaluation of PI-RADS Version 2.1 for Prostate Cancer Detection.,"OBJECTIVE.  The purpose of this study was to prospectively evaluate Prostate Imaging Reporting and Data and System version 2.1 (PI-RADSv2.1), which was released in March 2019 to update version 2.0, for prostate cancer detection with transrectal ultrasound-MRI fusion biopsy and 12-core systematic biopsy.  SUBJECTS AND METHODS.  This prospective study included 110 consecutively registered patients who underwent multiparametric MRI evaluated with PI-RADSv2.1 criteria followed by fusion biopsy and systematic biopsy between April and September 2019. Lesion-based cancer detection rates (CDRs) were calculated for prostate cancer (Gleason grade group, > 0) and clinically significant prostate cancer (Gleason grade group, > 1).  RESULTS.  A total of 171 lesions (median size, 1.1 cm) in 110 patients were detected and evaluated with PI-RADSv2.1. In 16 patients no lesion was detected, and only systematic biopsy was performed. Lesions were categorized as follows: PI-RADS category 1, 1 lesion; PI-RADS category 2, 34 lesions; PI-RADS category 3, 54 lesions; PI-RADS category 4, 52 lesions; and PI-RADS category 5, 30 lesions. Histopathologic analysis revealed prostate cancer in 74 of 171 (43.3%) lesions and clinically significant prostate cancer in 57 of 171 (33.3%) lesions. The CDRs of prostate cancer for PI-RADS 2, 3, 4, and 5 lesions were 20.0%, 24.1%, 51.9%, and 90.0%. The CDRs of clinically significant prostate cancer for PI-RADS 1, 2, 3, 4, and 5 lesions were 0%, 5.7%, 14.8%, 44.2%, and 80.0%. In 16 patients with normal multiparametric MRI findings (PI-RADS 1), the CDRs were 50.0% for PCa and 18.8% for clinically significant prostate cancer.  CONCLUSION.  This investigation yielded CDRs assessed with prospectively assigned PI-RADSv2.1 scores. CDRs increased with higher PI-RADSv2.1 scores. These results can be compared with previously published outcomes derived with PI-RADS version 2.0.",2020,Histopathologic analysis revealed prostate cancer in 74 of 171 (43.3%) lesions and clinically significant prostate cancer in 57 of 171 (33.3%) lesions.,"['Prostate Cancer Detection', '110 consecutively registered patients who underwent multiparametric MRI evaluated with PI-RADSv2.1 criteria followed by fusion biopsy and systematic biopsy between April and September 2019']","['PI-RADS', 'transrectal ultrasound-MRI fusion biopsy and 12-core systematic biopsy']","['prostate cancer', 'Lesion-based cancer detection rates (CDRs', 'CDRs']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0406775', 'cui_str': 'Symmetrical dyschromatosis of extremities'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",110.0,0.020686,Histopathologic analysis revealed prostate cancer in 74 of 171 (43.3%) lesions and clinically significant prostate cancer in 57 of 171 (33.3%) lesions.,"[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Walker', 'Affiliation': 'Molecular Imaging Program, National Cancer Institute, National Institutes of Health, 10 Center Dr, Rm B3B85, Bethesda, MD 20892.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Mehralivand', 'Affiliation': 'Molecular Imaging Program, National Cancer Institute, National Institutes of Health, 10 Center Dr, Rm B3B85, Bethesda, MD 20892.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Harmon', 'Affiliation': 'Molecular Imaging Program, National Cancer Institute, National Institutes of Health, 10 Center Dr, Rm B3B85, Bethesda, MD 20892.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sanford', 'Affiliation': 'Molecular Imaging Program, National Cancer Institute, National Institutes of Health, 10 Center Dr, Rm B3B85, Bethesda, MD 20892.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Merino', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Bradford J', 'Initials': 'BJ', 'LastName': 'Wood', 'Affiliation': 'Center for Interventional Oncology, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Joanna H', 'Initials': 'JH', 'LastName': 'Shih', 'Affiliation': 'Biometric Research Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Pinto', 'Affiliation': 'Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Choyke', 'Affiliation': 'Molecular Imaging Program, National Cancer Institute, National Institutes of Health, 10 Center Dr, Rm B3B85, Bethesda, MD 20892.'}, {'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Turkbey', 'Affiliation': 'Molecular Imaging Program, National Cancer Institute, National Institutes of Health, 10 Center Dr, Rm B3B85, Bethesda, MD 20892.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22679']
288,32862469,Determining Thresholds for Meaningful Change for the Headache Impact Test (HIT-6) Total and Item-Specific Scores in Chronic Migraine.,"OBJECTIVE


The objective of the analyses described here was to develop thresholds defining clinically meaningful response on the total and item scores of the 6-item short-form Headache Impact Test (HIT-6) in a population of patients with chronic migraine (CM).
BACKGROUND


The HIT-6 is a short, easily understood, and useful measure of the impact of headache on daily life. Though widely used, limited literature supports a threshold value for clinically meaningful response within individuals over time for the HIT-6 total score and for the item scores, especially in the CM population.
METHODS


PROMISE-2 is a randomized, double-blind, multicenter study comparing intravenous eptinezumab 100 and 300 mg with placebo for the preventive treatment of CM. Responder definitions for HIT-6 total and items scores using data from PROMISE-2 study were calculated via distribution-based and anchor-based methods. Distribution-based methods included half of the baseline standard deviation and baseline standard error of measurement. The change from baseline to week 12 in HIT-6 scores was assessed using the following anchors: patient global impression of change, reduction in migraine frequency, and change in EuroQol 5 dimensions 5 levels visual analog scale. Values from the literature and PROMISE-2 analyses were plotted against the cumulative distribution function of change values (baseline to week 12) and used to triangulate to empirically support clinically meaningful change definitions for the HIT-6 total and item scores in patients with CM.
RESULTS


From the literature, 5 articles provided 7 candidate values for a responder threshold for the HIT-6 total score. From distribution- and anchor-based methods, 5 candidate values were derived from PROMISE-2 data. Using the median of all candidate values, a HIT-6 total score responder definition estimate of -6 (ie, ≥6-point improvement in the total score) appears most appropriate for discriminating between individuals with CM who have experienced meaningful change over time and those who have not. For item-level analyses using anchor-based methods, the responder definition for items 1-3 (""severe pain,"" ""limits daily activities,"" and ""lie down"") was a 1-category improvement in response (eg, from Sometimes to Rarely); for items 4-6 (""too tired,"" ""felt fed up or irritated,"" and ""limits concentration""), a 2-category improvement in response (eg, from Always to Sometimes) was clinically meaningful.
CONCLUSIONS


Using a multifaceted, statistically-based approach, the recommended responder definition for the HIT-6 total score in the CM population is a ≥6-point decrease, consistent with previous literature. Anchor-based item-level responder thresholds were defined as a decrease of 1 or 2 categories, depending on the item. These CM-specific values will provide researchers and clinicians a means to interpret clinically meaningful change in the HIT-6 total and item scores and may facilitate the measurement of treatment benefits in specific functional domains of the HIT-6.",2020,The change from baseline to week 12 in HIT-6,['patients with chronic migraine (CM'],['intravenous eptinezumab 100 and 300 mg with placebo'],"['Headache Impact Test (HIT-6) Total and Item-Specific Scores', 'migraine frequency, and change in EuroQol 5 dimensions 5 levels visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4694272', 'cui_str': 'eptinezumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0898891,The change from baseline to week 12 in HIT-6,"[{'ForeName': 'Carrie R', 'Initials': 'CR', 'LastName': 'Houts', 'Affiliation': 'Vector Psychometric Group, LLC, Chapel Hill, NC, USA.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Wirth', 'Affiliation': 'Vector Psychometric Group, LLC, Chapel Hill, NC, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'McGinley', 'Affiliation': 'Vector Psychometric Group, LLC, Chapel Hill, NC, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': 'Neurology, Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Neurology, Epidemiology and Population Health, Psychiatry and Behavioral Sciences, Division of Cognitive Aging and Dementia, Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Headache,['10.1111/head.13946']
289,32878963,"DUETTE: a phase II randomized, multicenter study to investigate the efficacy and tolerability of a second maintenance treatment in patients with platinum-sensitive relapsed epithelial ovarian cancer, who have previously received poly(ADP-ribose) polymerase (PARP) inhibitor maintenance treatment.","BACKGROUND


With the success of poly(ADP-ribose) polymerase (PARP) inhibitor therapy in the first-line and second-line treatment settings, a new patient population is emerging with platinum-sensitive relapsed ovarian cancer, who have previously received a PARP inhibitor in the maintenance setting and for whom no second maintenance standard of care exists. DUETTE (NCT04239014) will evaluate the combination of ceralasertib (a potent, selective inhibitor of the serine/threonine kinase ataxia telangiectasia and Rad3-related protein (ATR) + olaparib, or olaparib monotherapy, compared with placebo, in this patient population of unmet need.
PRIMARY OBJECTIVE


The primary objective is to assess the efficacy of ceralasertib + olaparib combination, and olaparib monotherapy, compared with placebo, as second maintenance therapy in platinum-sensitive relapsed ovarian cancer.
STUDY HYPOTHESIS


This study will test the hypothesis that ceralasertib + olaparib, or olaparib monotherapy, is tolerable, and effective at prolonging progression-free survival compared with placebo.
TRIAL DESIGN


This is a phase II, multicenter study where patients will be randomized in a 1:1:1 ratio to receive either (Arm 1) ceralasertib + olaparib, (Arm 2) olaparib monotherapy, or (Arm 3) placebo. The olaparib and placebo arms will be double-blinded, whereas the ceralasertib + olaparib arm will be open label. Patients will be stratified according to  BRCA  status, and response to platinum-based chemotherapy.
MAJOR INCLUSION/EXCLUSION CRITERIA


Eligible patients will have histologically diagnosed high-grade epithelial ovarian cancer, with platinum-sensitive relapse on, or after, completion of at least 6 months of any prior PARP inhibitor maintenance therapy (a minimum of 12 months is required if the patient received PARP inhibitor maintenance following first-line chemotherapy). If the prior PARP inhibitor used was olaparib then patients must have received treatment without significant toxicity or the need for a permanent dose reduction. Disease relapse in the second-line or third-line setting is allowed. Patients who have received secondary debulking surgery are potentially eligible if they meet all other inclusion criteria.
PRIMARY ENDPOINTS


The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1.
SAMPLE SIZE


192 patients.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


December 2022.
TRIAL REGISTRATION


NCT04239014.",2020,"The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1.
","['platinum-sensitive relapsed ovarian cancer', '192 patients', 'Eligible patients will have histologically diagnosed high-grade epithelial ovarian cancer, with platinum-sensitive relapse on, or after, completion of at least 6 months of any prior', 'Patients who have received secondary debulking surgery are potentially eligible if they meet all other inclusion criteria', 'patients with platinum-sensitive relapsed epithelial ovarian cancer, who have previously received poly(ADP-ribose) polymerase (PARP) inhibitor maintenance treatment', 'December 2022']","['olaparib and placebo', 'PARP inhibitor', 'Rad3-related protein (ATR) + olaparib, or olaparib monotherapy', 'poly(ADP-ribose) polymerase (PARP) inhibitor therapy', 'placebo', 'ceralasertib + olaparib, (Arm 2) olaparib monotherapy, or (Arm 3) placebo', 'PARP inhibitor maintenance therapy', 'ceralasertib + olaparib, or olaparib monotherapy', 'ceralasertib + olaparib combination, and olaparib monotherapy']","['progression-free survival', 'Disease relapse', 'efficacy and tolerability']","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C3711837', 'cui_str': 'ATR protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.260806,"The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McMullen', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Karakasis', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Bienvenu', 'Initials': 'B', 'LastName': 'Loembe', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dean', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Graem', 'Initials': 'G', 'LastName': 'Parr', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada amit.oza@uhn.ca.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001694']
290,32893098,The long-term effect of neurodynamics vs exercise therapy on pain and function in people with carpal tunnel syndrome: A randomized parallel-group clinical trial.,"INTRODUCTION


Carpal tunnel syndrome (CTS) is a common disorder that limits function and quality of life. Little evidence is available on the long-term effect of neurodynamics and exercise therapy.
PURPOSE OF THE STUDY


This study aimed to examine the long-term effect of neurodynamic techniques vs exercise therapy in managing patients with CTS.
STUDY DESIGN


Parallel group randomized clinical trial.
METHODS


Of 57 patients screened, 51 were randomly assigned to either receiving four sessions of neurodynamics and exercise or home exercise therapy alone as a control. Blinded assessment was performed before treatment allocation, at treatment completion, and 6 months posttreatment. Outcome measures included Symptom Severity Scale (SSS), Functional Status Scale (FSS), Shortened version of the Disabilities of the Arm, Shoulder, and Hand (DASH), Numerical Pain Rating Scale, grip strength and range of motion.
RESULTS


Data from 41 individuals (52 hands) were analyzed. The neurodynamics group demonstrated significant improvement in all outcome measures at 1 and 6 months (P < .05). Mean difference in SSS was 1.4 (95% CI= 0.9-1.4) at 1 month and 1.6 (95% CI = 0.9-2.2) at 6 months. Mean difference in FSS was 0.9 (95% CI = 0.4-1.4) at 1 month and 1.4 (95% CI = 0.7-2.0) at 6 months. Significant between-group differences were found in pain score at 1 month (-1.93) and in FSS (-0.5) and Shortened version of DASH (-12.6) at 6 months (P < .05). No patient needed surgery 1 year after treatment.
CONCLUSIONS


Although both treatments led to positive outcomes, neurodynamics therapy was superior in improving function and strength and in decreasing pain.",2021,Significant between-group differences were found in pain score at 1 month (-1.93) and in FSS (-0.5) and Shortened version of DASH (-12.6) at 6 months (P < .05).,"['managing patients with CTS', 'Of 57 patients screened, 51', 'people with carpal tunnel syndrome', '41 individuals (52 hands']","['neurodynamic techniques vs exercise therapy', 'neurodynamics vs exercise therapy', 'neurodynamics and exercise or home exercise therapy alone']","['Mean difference in SSS', 'Mean difference in FSS', 'Symptom Severity Scale (SSS), Functional Status Scale (FSS), Shortened version of the Disabilities of the Arm, Shoulder, and Hand (DASH), Numerical Pain Rating Scale, grip strength and range of motion', 'pain and function', 'function and strength and in decreasing pain', 'pain score', 'FSS (-0.5) and Shortened version of DASH']","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444500', 'cui_str': '0.5'}]",51.0,0.196144,Significant between-group differences were found in pain score at 1 month (-1.93) and in FSS (-0.5) and Shortened version of DASH (-12.6) at 6 months (P < .05).,"[{'ForeName': 'Hayat', 'Initials': 'H', 'LastName': 'Hamzeh', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, The University of Jordan, Amman, Jordan. Electronic address: h.hamzeh@ju.edu.jo.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Madi', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, The Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Alia A', 'Initials': 'AA', 'LastName': 'Alghwiri', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Hawamdeh', 'Affiliation': 'Department of Special Surgery, Orthopaedic and Rehabilitation Medicine Section, School of Medicine, The University of Jordan, Amman, Jordan.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.07.005']
291,32888746,"Potential efficacy of sensorimotor exercise program on pain, proprioception, mobility, and quality of life in diabetic patients with foot burns: A 12-week randomized control study.","BACKGROUND


Both diabetes mellitus (DM) and burn injuries lead to physical and psychological impairments. Foot burns are still a challenging health condition because of its important sensory role. No previous studies have assessed the physical therapy intervention on diabetic patients with foot burns. Therefore, this study aimed to assess the potential efficacy of sensorimotor exercise on pain, proprioception, mobility, balance, and quality of life in diabetic patients with foot burns.
METHODS


Between July 2019 and February 2020, thirty-three diabetic patients with foot burns, aged 32 to 46yrs, were enrolled in this randomized control study, and randomized consecutively into two groups, study group (n=16) and control group (n=17). The study group underwent a sensorimotor exercise program thrice a week for 12 consecutive weeks, however the control group did not undergo the exercise intervention. Both groups were instructed to conduct home exercises. Visual analogue scale (VAS), proprioceptive responses, time-up and go (TUG) values, and short form-36 (SF-36) have been assessed prior and subsequent to the study intervention.
RESULTS


No significant differences were observed between groups regarding baseline data (p˃0.05). Subsequent to 12wk intervention, the study group showed significant improvements in outcome measures (proprioceptive responses, p˂0.05, VAS, p˂0.001, TUG, p=0.003, and SF-36, p˂0.001) and the control group exhibited significant changes in VAS and SF-36 (p=0.004, p=0.043 respectively) however, no significant changes were found in proprioceptive responses and TUG values (p˃0.05). Between groups, the post-intervention comparison demonstrated statistical differences with tending toward the study group (proprioceptive responses, p˂0.05, VAS, p˂0.001, TUG, p=0.013, and SF-36, p=0.046).
CONCLUSIONS


Sensorimotor exercise training may improve, pain, proprioceptive responses, mobility, balance, and quality of life in diabetic patients with foot burns. Physiotherapists and rehabilitation providers should include the sensorimotor exercise in their protocols in the treatment of diabetic patients with foot burns.",2021,"Subsequent to 12wk intervention, the study group showed significant improvements in outcome measures (proprioceptive responses, p˂0.05, VAS, p˂0.001, TUG, p=0.003, and SF-36, p˂0.001) and the control group exhibited significant changes in VAS and SF-36 (p=0.004, p=0.043 respectively) however, no significant changes were found in proprioceptive responses and TUG values (p˃0.05).","['Between July 2019 and February 2020, thirty-three diabetic patients with foot burns, aged 32 to 46yrs', 'diabetic patients with foot burns']","['physical therapy intervention', 'Sensorimotor exercise training', 'sensorimotor exercise program', 'control group did not undergo the exercise intervention', 'sensorimotor exercise']","['proprioceptive responses and TUG values', 'pain, proprioception, mobility, and quality of life', 'Visual analogue scale (VAS), proprioceptive responses, time-up and go (TUG) values, and short form-36 (SF-36', 'pain, proprioception, mobility, balance, and quality of life', 'pain, proprioceptive responses, mobility, balance, and quality of life', 'VAS and SF-36', 'outcome measures (proprioceptive responses, p˂0.05, VAS']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231772', 'cui_str': 'Burning feet'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",33.0,0.0148595,"Subsequent to 12wk intervention, the study group showed significant improvements in outcome measures (proprioceptive responses, p˂0.05, VAS, p˂0.001, TUG, p=0.003, and SF-36, p˂0.001) and the control group exhibited significant changes in VAS and SF-36 (p=0.004, p=0.043 respectively) however, no significant changes were found in proprioceptive responses and TUG values (p˃0.05).","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia; Department of Physical Therapy, Kasr Al-Aini Hospital, Cairo University, Giza, Egypt. Electronic address: walidkamal.wr@gmail.com.'}, {'ForeName': 'Shereen H', 'Initials': 'SH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health and Rehabilitation Sciences, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia; Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Sayed A', 'Initials': 'SA', 'LastName': 'Tantawy', 'Affiliation': 'Department of Physiotherapy, Center of Radiation Oncology & Nuclear Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Dalia M', 'Initials': 'DM', 'LastName': 'Kamel', 'Affiliation': ""Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University, Giza, Egypt.""}, {'ForeName': 'Marwa M', 'Initials': 'MM', 'LastName': 'Eid', 'Affiliation': 'Department of Physical Therapy, College of Applied Medical Sciences, Taif University, Taif, Saudi Arabia; Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia; Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Saud F', 'Initials': 'SF', 'LastName': 'Alsubaie', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.08.002']
292,32886102,Effect of Multilevel Upper Airway Surgery vs Medical Management on the Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness Among Patients With Moderate or Severe Obstructive Sleep Apnea: The SAMS Randomized Clinical Trial.,"Importance


Many adults with obstructive sleep apnea (OSA) use device treatments inadequately and remain untreated.
Objective


To determine whether combined palatal and tongue surgery to enlarge or stabilize the upper airway is an effective treatment for patients with OSA when conventional device treatment failed.
Design, Setting, and Participants


Multicenter, parallel-group, open-label randomized clinical trial of upper airway surgery vs ongoing medical management. Adults with symptomatic moderate or severe OSA in whom conventional treatments had failed were enrolled between November 2014 and October 2017, with follow-up until August 2018.
Interventions


Multilevel surgery (modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction; n = 51) or ongoing medical management (eg, advice on sleep positioning, weight loss; n = 51).
Main Outcomes and Measures


Primary outcome measures were the apnea-hypopnea index (AHI; ie, the number of apnea and hypopnea events/h; 15-30 indicates moderate and >30 indicates severe OSA) and the Epworth Sleepiness Scale (ESS; range, 0-24; >10 indicates pathological sleepiness). Baseline-adjusted differences between groups at 6 months were assessed. Minimal clinically important differences are 15 events per hour for AHI and 2 units for ESS.
Results


Among 102 participants who were randomized (mean [SD] age, 44.6 [12.8] years; 18 [18%] women), 91 (89%) completed the trial. The mean AHI was 47.9 at baseline and 20.8 at 6 months for the surgery group and 45.3 at baseline and 34.5 at 6 months for the medical management group (mean baseline-adjusted between-group difference at 6 mo, -17.6 events/h [95% CI, -26.8 to -8.4]; P < .001). The mean ESS was 12.4 at baseline and 5.3 at 6 months in the surgery group and 11.1 at baseline and 10.5 at 6 months in the medical management group (mean baseline-adjusted between-group difference at 6 mo, -6.7 [95% CI, -8.2 to -5.2]; P < .001). Two participants (4%) in the surgery group had serious adverse events (1 had a myocardial infarction on postoperative day 5 and 1 was hospitalized for observation following hematemesis of old blood).
Conclusions and Relevance


In this preliminary study of adults with moderate or severe OSA in whom conventional therapy had failed, combined palatal and tongue surgery, compared with medical management, reduced the number of apnea and hypopnea events and patient-reported sleepiness at 6 months. Further research is needed to confirm these findings in additional populations and to understand clinical utility, long-term efficacy, and safety of multilevel upper airway surgery for treatment of patients with OSA.
Trial Registration


Australian New Zealand Clinical Trials Registry: ACTRN12614000338662.",2020,"events/h [95% CI, -26.8 to -8.4]; P < .001).","['102 participants who were randomized (mean [SD] age, 44.6 [12.8] years; 18 [18%] women), 91 (89%) completed the trial', 'Adults with symptomatic moderate or severe OSA in whom conventional treatments had failed were enrolled from August 2014 to November 2017, with follow-up until August 2018', 'Patients With Moderate or Severe Obstructive Sleep Apnea', 'adults with moderate or severe OSA in whom conventional therapy had failed, combined palatal and tongue surgery', 'adults with obstructive sleep apnea (OSA', 'patients with OSA']","['upper airway surgery vs ongoing medical management', 'Multilevel Upper Airway Surgery vs Medical Management', 'combined palatal and tongue surgery', 'Interventions\n\n\nMultilevel surgery (modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction; n\u2009=\u200951) or ongoing medical management (eg, advice on sleep positioning, weight loss; n\u2009=\u200951']","['mean AHI', 'mean ESS', 'Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness', 'apnea-hypopnea index (AHI; ie, the number of apnea and hypopnea events/h; 15-30 indicates moderate and >30 indicates severe OSA) and the Epworth Sleepiness Scale (ESS; range, 0-24; >10 indicates pathological sleepiness', 'number of apnea and hypopnea events and patient-reported sleepiness', 'serious adverse events']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1535578', 'cui_str': 'Palatopharyngoplasty'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0776524,"events/h [95% CI, -26.8 to -8.4]; P < .001).","[{'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'MacKay', 'Affiliation': 'Illawarra Shoalhaven Local Health District, Wollongong, NSW, Australia.'}, {'ForeName': 'A Simon', 'Initials': 'AS', 'LastName': 'Carney', 'Affiliation': 'Southern ENT & Adelaide Sinus Centre, Flinders Private Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Catcheside', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Ching Li', 'Initials': 'CL', 'LastName': 'Chai-Coetzer', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chia', 'Affiliation': 'Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Cistulli', 'Affiliation': 'Charles Perkins Centre, Faculty for Medicine and Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'John-Charles', 'Initials': 'JC', 'LastName': 'Hodge', 'Affiliation': 'Ear Nose and Throat Department, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Illawarra Shoalhaven Local Health District, Wollongong, NSW, Australia.'}, {'ForeName': 'Billingsley', 'Initials': 'B', 'LastName': 'Kaambwa', 'Affiliation': 'Health Economics Unit, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Hollywood Medical Centre, Perth, WA, Australia.'}, {'ForeName': 'Eng H', 'Initials': 'EH', 'LastName': 'Ooi', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Pinczel', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'McArdle', 'Affiliation': 'West Australian Sleep Disorders Research Institute, Queen Elizabeth II Medical Centre, Perth, WA, Australia.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Rees', 'Affiliation': 'The Memorial Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Bhajan', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'West Australian Sleep Disorders Research Institute, Queen Elizabeth II Medical Centre, Perth, WA, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Stow', 'Affiliation': 'The Woolcock Clinic, University of Sydney, NSW, Australia.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Weaver', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, University of Washington, Seattle.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Charmaine M', 'Initials': 'CM', 'LastName': 'Woods', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Aeneas', 'Initials': 'A', 'LastName': 'Yeo', 'Affiliation': 'Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}]",JAMA,['10.1001/jama.2020.14265']
293,32892250,Effect of ketogenic diet versus regular diet on voice quality of patients with Parkinson's disease.,Diets that have effects on health problems can vary in their composition. Whilst following a regular diet (RD) a person typically consumes about 30% of calories from fat. Ketogenic diet (KD) is a form of diet whereby a person consumes as much as 90% of calories from fat. KD has been trialed as a treatment for neurological diseases and obesity. Parkinson's disease (PD) is a neurologic disease that impacts the quality of voice. Voice Handicap Index (VHI) is a test that gives information to clinical and physiological assessment about voice. We assessed the impact of KD and RD on voice quality (VQ). Seventy-four patients with PD who reported a voice disorder related to their disease were randomly assigned to the KD or RD groups. We investigated the VHI change of subjects before and 3 months after diet. Sixty-eight PD patients completed the study. Baseline VHI values did not differ significantly between groups. All mean VHI parameters improved in KD group (p˂ 0.001). Currently there are different therapies that address speech and voice disorders in patients with PD. As such KD may be an alternative therapy to improve VQ of patients with PD. A larger sample size is necessary to determine the role and pathophysiology of KD on VQ of PD patients.,2021,All mean VHI parameters improved in KD group (p˂ 0.001).,"[""Parkinson's disease (PD"", 'patients with PD', 'Sixty-eight PD patients completed the study', ""patients with Parkinson's disease"", 'Seventy-four patients with PD who reported a voice disorder related to their disease']","['ketogenic diet versus regular diet', 'Ketogenic diet (KD', 'KD']","['mean VHI parameters', 'voice quality (VQ', 'voice quality', 'Voice Handicap Index (VHI', 'Baseline VHI values']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",74.0,0.0166714,All mean VHI parameters improved in KD group (p˂ 0.001).,"[{'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Koyuncu', 'Affiliation': 'Department of Otorhinolaryngology, Eskisehir Gov Hosp, Cavdarlar Street, Eskisehir, 26080, Turkey.'}, {'ForeName': 'Vural', 'Initials': 'V', 'LastName': 'Fidan', 'Affiliation': 'Department of Otorhinolaryngology, Eskisehir Gov Hosp, Cavdarlar Street, Eskisehir, 26080, Turkey. vuralf@mynet.com.'}, {'ForeName': 'Hayal', 'Initials': 'H', 'LastName': 'Toktas', 'Affiliation': 'Department of Neurology, Atasehir Memorial Hospital, Istanbul, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Binay', 'Affiliation': 'Department of Otorhinolaryngology, Corlu State Hospital, Tekirdag, Turkey.'}, {'ForeName': 'Hamit', 'Initials': 'H', 'LastName': 'Celik', 'Affiliation': 'Department of Neurology, Buhara Hospital, Erzurum, Turkey.'}]",Acta neurologica Belgica,['10.1007/s13760-020-01486-0']
294,32885676,Information Seeking Behaviors and Intentions in Response to Environmental Health Risk Messages: A Test of A Reduced Risk Information Seeking Model.,"This study tests the effects of environmental health risk messages on perceived risk, information needs and decisions to seek information, testing a reduced risk information seeking and processing model (R-RISP). Participants ( N  = 1,823) were randomized to one of three risk conditions (arsenic, bisphenol A [BPA] or volatile organic compounds [VOCs]) and one of the three message conditions (high threat, low threat or no message); participants in the high and low threat message conditions were also randomly assigned to a seeking cue to action condition (with or without seeking cue). Overall, the results support the R-RISP model, demonstrating the importance of current knowledge perceptions and informational subjective norms in information acquisition decisions. In addition, the results also provide initial evidence that environmental health risk messages can prompt information seeking and increase intentions to seek information in the future. Avenues for future research are discussed.",2021,"Overall, the results support the R-RISP model, demonstrating the importance of current knowledge perceptions and informational subjective norms in information acquisition decisions.","['Participants ( N  =\xa01,823']","['environmental health risk messages', 'risk conditions (arsenic, bisphenol A [BPA] or volatile organic compounds [VOCs]) and one of the three message conditions (high threat, low threat or no message); participants in the high and low threat message conditions', 'seeking cue to action condition (with or without seeking cue']",['Risk Messages'],[],"[{'cui': 'C0014413', 'cui_str': 'Health, Environmental'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0003818', 'cui_str': 'Arsenic'}, {'cui': 'C0053800', 'cui_str': 'bisphenol A'}, {'cui': 'C2350439', 'cui_str': 'Volatile Organic Compounds'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}]",1823.0,0.0191621,"Overall, the results support the R-RISP model, demonstrating the importance of current knowledge perceptions and informational subjective norms in information acquisition decisions.","[{'ForeName': 'Shelly R', 'Initials': 'SR', 'LastName': 'Hovick', 'Affiliation': 'School of Communication, The Ohio State University.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bigsby', 'Affiliation': 'Department of Communication, University of Illinois at Urbana-Champaign.'}, {'ForeName': 'Sam R', 'Initials': 'SR', 'LastName': 'Wilson', 'Affiliation': 'Department of Communication, University of Illinois at Urbana-Champaign.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'School of Communication, The Ohio State University.'}]",Health communication,['10.1080/10410236.2020.1804139']
295,32914569,"Adiposity and cardiovascular outcomes in three-year-old children of participants in UPBEAT, an RCT of a complex intervention in pregnant women with obesity.","BACKGROUND


Maternal obesity is associated with offspring cardiometabolic risk. UPBEAT was a randomised controlled trial of an antenatal diet and physical activity intervention in 1555 women with obesity. The intervention was associated with lower gestational weight gain, healthier diet and metabolic profile in pregnancy, and reduced infant adiposity at six months.
OBJECTIVE


We have investigated whether the UPBEAT intervention influenced childhood cardiometabolic outcomes or was associated with sustained improvements in maternal lifestyle 3-years after delivery.
METHODS


In UPBEAT mother-child dyads at the 3-year follow-up, we assessed childhood blood pressure, resting pulse rate, and adiposity (body mass index, skinfold thicknesses, body fat, waist and arm circumferences) and maternal diet, physical activity, and anthropometry.
RESULTS


514 three-year-old children attended the appointment (49% intervention, 51% standard care). There was no difference in the main outcome of interest, subscapular skinfold thickness, between the trial arms (-0.30 mm, 95% confidence interval: -0.92, 0.31). However, the intervention was associated with a lower resting pulse rate (-5 bpm [-8.41, -1.07]). There was also a non-significant lower odds of overweight/obesity (OR 0.73; 0.50, 1.08). Maternal dietary improvements observed in the UPBEAT trial, including glycaemic load and saturated fat were maintained 3-years postpartum.
CONCLUSION


This study has demonstrated that an antenatal dietary and physical activity intervention in women with obesity is associated with lower offspring pulse rate and sustained improvement in maternal diet. Whilst larger than previous cohorts, there remains potential for bias from attrition and these findings require validation in future cohorts.",2021,"The intervention was associated with lower gestational weight gain, healthier diet and metabolic profile in pregnancy, and reduced infant adiposity at six months.
","['three-year-old children of participants in', 'women with obesity', 'pregnant women with obesity', '514 three-year-old children attended the appointment (49% intervention, 51% standard care', '1555 women with obesity']","['UPBEAT intervention', 'antenatal dietary and physical activity intervention', 'antenatal diet and physical activity intervention', 'UPBEAT']","['glycaemic load and saturated fat', 'childhood blood pressure, resting pulse rate, and adiposity (body mass index, skinfold thicknesses, body fat, waist and arm circumferences) and maternal diet, physical activity, and anthropometry', 'overweight/obesity', 'lower gestational weight gain, healthier diet and metabolic profile in pregnancy, and reduced infant adiposity', 'childhood cardiometabolic outcomes', 'Adiposity and cardiovascular outcomes', 'interest, subscapular skinfold thickness', 'resting pulse rate']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",1555.0,0.0905984,"The intervention was associated with lower gestational weight gain, healthier diet and metabolic profile in pregnancy, and reduced infant adiposity at six months.
","[{'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Dalrymple', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Florence A S', 'Initials': 'FAS', 'LastName': 'Tydeman', 'Affiliation': 'Department of Mathematics and Statistics, Faculty of Science, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Taylor', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Flynn', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Majella', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Briley', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Paramala', 'Initials': 'P', 'LastName': 'Santosh', 'Affiliation': ""Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Robson', 'Affiliation': 'Institute of Cellular Medicine, Uterine Cell Signalling Group, The Medical School, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Nelson', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, British Heart Foundation, Glasgow, Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Whitworth', 'Affiliation': ""Maternity Services, Central Manchester University Hospitals NHS Foundation Trust, St Mary's Hospital, Manchester, UK.""}, {'ForeName': 'Harriet L', 'Initials': 'HL', 'LastName': 'Mills', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Oakfield House, Bristol, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Singh', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed CStat', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'White', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Lawlor', 'Affiliation': 'NIHR Bristol Biomedical Research Centre, Bristol, UK.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit and NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric obesity,['10.1111/ijpo.12725']
296,32914838,Evaluation of a Text Messaging-Based Human Papillomavirus Vaccination Intervention for Young Sexual Minority Men: Results from a Pilot Randomized Controlled Trial.,"BACKGROUND


Men who have sex with men (MSM) are at high risk for human papillomavirus (HPV) infection and HPV-related anal cancer. Although a safe and effective vaccine is available to prevent HPV infection, HPV vaccine uptake among young MSM remains low.
PURPOSE


This pilot randomized controlled trial tested the acceptability, feasibility, and preliminary efficacy of a text messaging-based HPV vaccination intervention for young sexual minority men.
METHODS


In 2018, unvaccinated sexual minority men aged 18-25 years were recruited from Chicago to participate in a 9 month sexual health program called txt2protect. Participants (N = 150) were randomized to the intervention or control condition. Intervention condition messages focused primarily on HPV vaccination, with only a brief mention of other sexual health practices (e.g., condom use and HIV testing), while control condition messages focused on a variety of sexual health practices with only a brief mention of HPV vaccination. Participants received daily text messages for the first 3 weeks and monthly text messages for the remaining ~8 months of the trial. Participants completed surveys at baseline and 3 week and 9 month follow-ups.
RESULTS


Participants reported high satisfaction with the intervention. Although trial retention was high (with over 88% completing the 9 month survey), the study fell short of meeting its recruitment goal. HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%), odds ratio = 3.43, 95% confidence interval: 1.17, 10.08.
CONCLUSIONS


Findings suggest that txt2protect is an acceptable and potentially promising intervention for increasing HPV vaccine initiation among young sexual minority men.
CLINICAL TRIAL REGISTRATION


NCT02994108.",2021,HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%),"['young sexual minority men', 'Participants (N = 150', 'Young Sexual Minority Men', '2018, unvaccinated sexual minority men aged 18-25 years were recruited from Chicago to participate in a 9 month sexual health program called txt2protect', 'Men who have sex with men (MSM']","['Intervention condition messages focused primarily on HPV vaccination, with only a brief mention of other sexual health practices (e.g., condom use and HIV testing), while control condition messages focused on a variety of sexual health practices with only a brief mention of HPV vaccination', 'Text Messaging-Based Human Papillomavirus Vaccination Intervention', 'text messaging-based HPV vaccination intervention']",['HPV vaccine series initiation'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",150.0,0.217267,HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%),"[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Gerend', 'Affiliation': 'Department of Behavioral Sciences and Social Medicine, College of Medicine, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Madkins', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Shariell', 'Initials': 'S', 'LastName': 'Crosby', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Korpak', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Phillips', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bass', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Houlberg', 'Affiliation': 'Howard Brown Health, Chicago, IL, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa056']
297,32900246,A randomized placebo-controlled study investigating the efficacy of inspiratory muscle training in the treatment of children with bronchial asthma.,"OBJECTIVE


To investigate the efficacy of inspiratory muscle training (IMT) on respiratory functions, respiratory muscle strength, and asthma symptoms in asthmatic children.
METHODS


In a randomized placebo-controlled assessor-blinded study, 34 children with asthma were randomized to receive either the IMT at 40% of the maximal inspiratory pressure (IP max ) for 20 min/session, thrice/week, over 12 consecutive weeks (IMT group;  n  = 17) or placebo IMT at 5% of IP max  (placebo group;  n  = 17). Additionally, both groups received the conventional respiratory rehabilitation (CRR) program. Outcome measurements performed pre- and post-treatment, included respiratory functions [forced expiratory volume at the first second (FEV 1 ), forced vital capacity (FEV), and FEV 1 /FVC], respiratory muscle strength [represented by IP max  and maximal expiratory pressure (EP max ), and asthma control test (ACT).
RESULTS


At a significance level adjusted to  P <.008, there were significant post-treatment differences between the IMT and placebo groups in FEV 1  ( P =.003), FVC ( P =.001), FEV 1 /FVC ( P =.004), IP max  ( P =.002), EP max  ( P =.004), and ACT ( P =.001) adjusted to the pretreatment values, in favor of the IMT group.
CONCLUSION


Incorporation of IMT in the CRR program for children with asthma can improve respiratory function, enhance respiratory muscle strength, and improve children's perception of asthma symptoms.",2021,"At a significance level adjusted to  P <.008, there were significant post-treatment differences between the IMT and placebo groups in FEV 1  ( P =.003), FVC ( P =.001), FEV 1 /FVC","['34 children with asthma', 'children with asthma', 'children with bronchial asthma', 'asthmatic children']","['IMT', 'inspiratory muscle training (IMT', 'conventional respiratory rehabilitation (CRR) program', 'placebo', 'inspiratory muscle training', 'maximal inspiratory pressure (IP max ', 'placebo IMT at 5% of IP max  (placebo']","['FEV 1 /FVC', 'EP max', ""children's perception of asthma symptoms"", 'pre- and post-treatment, included respiratory functions [forced expiratory volume at the first second (FEV 1 ), forced vital capacity (FEV), and FEV 1 /FVC], respiratory muscle strength [represented by IP max  and maximal expiratory pressure (EP max ), and asthma control test (ACT', 'respiratory functions, respiratory muscle strength, and asthma symptoms', 'FVC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",34.0,0.139749,"At a significance level adjusted to  P <.008, there were significant post-treatment differences between the IMT and placebo groups in FEV 1  ( P =.003), FVC ( P =.001), FEV 1 /FVC","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, Collage of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1821058']
298,32905676,"Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide.","BACKGROUND


Darolutamide is a structurally distinct androgen-receptor inhibitor that is approved for the treatment of nonmetastatic, castration-resistant prostate cancer. In the planned primary analysis of a phase 3 trial, the median metastasis-free survival was significantly longer with darolutamide (40.4 months) than with placebo (18.4 months). The data for the analysis of overall survival were immature at the time of the primary analysis.
METHODS


In this double-blind, placebo-controlled trial, we randomly assigned 1509 men, in a 2:1 ratio, to receive darolutamide (955 patients) or placebo (554 patients) while they continued to receive androgen-deprivation therapy. After the results of the primary end-point analysis were found to be positive, unblinding of the treatment assignments occurred, and patients in the placebo group were permitted to cross over to receive open-label darolutamide treatment. At the time of this prespecified final analysis, which had been planned to be performed after approximately 240 deaths had occurred, overall survival and all other secondary end points were evaluated.
RESULTS


The median follow-up time was 29.0 months. At the time of unblinding of the data, all 170 patients who were still receiving placebo crossed over to receive darolutamide; 137 patients who had discontinued placebo before unblinding had occurred received at least one other life-prolonging therapy. Overall survival at 3 years was 83% (95% confidence interval [CI], 80 to 86) in the darolutamide group and 77% (95% CI, 72 to 81) in the placebo group. The risk of death was significantly lower, by 31%, in the darolutamide group than in the placebo group (hazard ratio for death, 0.69; 95% CI, 0.53 to 0.88; P = 0.003). Darolutamide was also associated with a significant benefit with respect to all other secondary end points, including the time to first symptomatic skeletal event and the time to first use of cytotoxic chemotherapy. The incidence of adverse events after the start of treatment was similar in the two groups; no new safety signals were observed.
CONCLUSIONS


Among men with nonmetastatic, castration-resistant prostate cancer, the percentage of patients who were alive at 3 years was significantly higher among those who received darolutamide than among those who received placebo. The incidence of adverse events was similar in the two groups. (Funded by Bayer HealthCare and Orion Pharma; ARAMIS ClinicalTrials.gov number, NCT02200614.).",2020,"The incidence of adverse events after the start of treatment was similar in the two groups; no new safety signals were observed.
","['1509 men, in a 2:1 ratio, to receive darolutamide (955 patients) or', 'men with nonmetastatic, castration-resistant prostate cancer', '170 patients who were still receiving']","['androgen-deprivation therapy', 'placebo']","['Overall survival', 'risk of death', 'adverse events', 'median metastasis-free survival', 'time to first symptomatic skeletal event and the time to first use of cytotoxic chemotherapy', 'incidence of adverse events', 'overall survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",1509.0,0.695659,"The incidence of adverse events after the start of treatment was similar in the two groups; no new safety signals were observed.
","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Teuvo L', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Ulys', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Egils', 'Initials': 'E', 'LastName': 'Vjaters', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Polyakov', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Mindaugas', 'Initials': 'M', 'LastName': 'Jievaltas', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Luz', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kuss', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Le Berre', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Petrenciuc', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Snapir', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Sarapohja', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2001342']
299,32908007,Therapeutic responses to  Roseomonas mucosa  in atopic dermatitis may involve lipid-mediated TNF-related epithelial repair.,"Dysbiosis of the skin microbiota is increasingly implicated as a contributor to the pathogenesis of atopic dermatitis (AD). We previously reported first-in-human safety and clinical activity results from topical application of the commensal skin bacterium  Roseomonas mucosa  for the treatment of AD in 10 adults and 5 children older than 9 years of age. Here, we examined the potential mechanism of action of  R. mucosa  treatment and its impact on children with AD less than 7 years of age, the most common age group for children with AD. In 15 children with AD,  R. mucosa  treatment was associated with amelioration of disease severity, improvement in epithelial barrier function, reduced  Staphylococcus aureus  burden on the skin, and a reduction in topical steroid requirements without severe adverse events. Our observed response rates to  R. mucosa  treatment were greater than those seen in historical placebo control groups in prior AD studies. Skin improvements and colonization by  R. mucosa  persisted for up to 8 months after cessation of treatment. Analyses of cellular scratch assays and the MC903 mouse model of AD suggested that production of sphingolipids by  R. mucosa , cholinergic signaling, and flagellin expression may have contributed to therapeutic impact through induction of a TNFR2-mediated epithelial-to-mesenchymal transition. These results suggest that a randomized, placebo-controlled trial of  R. mucosa  treatment in individuals with AD is warranted and implicate commensals in the maintenance of the skin epithelial barrier.",2020,"In 15 children with AD,  R. mucosa  treatment was associated with amelioration of disease severity, improvement in epithelial barrier function, reduced  Staphylococcus aureus  burden on the skin, and a reduction in topical steroid requirements without severe adverse events.","['children with AD less than 7 years of age, the most common age group for children with AD', 'individuals with AD', '10 adults and 5 children older than 9 years of age']",['placebo'],['epithelial barrier function'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",15.0,0.0436594,"In 15 children with AD,  R. mucosa  treatment was associated with amelioration of disease severity, improvement in epithelial barrier function, reduced  Staphylococcus aureus  burden on the skin, and a reduction in topical steroid requirements without severe adverse events.","[{'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Myles', 'Affiliation': 'Epithelial Therapeutics Unit, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA. mylesi@niaid.nih.gov.'}, {'ForeName': 'Carlo R', 'Initials': 'CR', 'LastName': 'Castillo', 'Affiliation': 'Epithelial Therapeutics Unit, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kent D', 'Initials': 'KD', 'LastName': 'Barbian', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Kishore', 'Initials': 'K', 'LastName': 'Kanakabandi', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Virtaneva', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fitzmeyer', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Paneru', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Otaizo-Carrasquero', 'Affiliation': 'Genomic Technologies Section, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Myers', 'Affiliation': 'Genomic Technologies Section, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Tovah E', 'Initials': 'TE', 'LastName': 'Markowitz', 'Affiliation': 'NIAID Collaborative Bioinformatics Resource (NCBR), NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Ian N', 'Initials': 'IN', 'LastName': 'Moore', 'Affiliation': 'Infectious Disease Pathogenesis Section, Comparative Medicine Branch, NIAID, NIH, Rockville, MD, USA.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Pre-clinical Innovation, National Center for Advancing Translational Sciences, NIH, Rockville, MD, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ferrer', 'Affiliation': 'Department of Pre-clinical Innovation, National Center for Advancing Translational Sciences, NIH, Rockville, MD, USA.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Sakamachi', 'Affiliation': 'National Institute of Environmental Health Sciences, Research Triangle, NC, USA.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Garantziotis', 'Affiliation': 'National Institute of Environmental Health Sciences, Research Triangle, NC, USA.'}, {'ForeName': 'Muthulekha', 'Initials': 'M', 'LastName': 'Swamydas', 'Affiliation': 'Fungal Pathogenesis Section, LCIM, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Michail S', 'Initials': 'MS', 'LastName': 'Lionakis', 'Affiliation': 'Fungal Pathogenesis Section, LCIM, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Anderson', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Noah J', 'Initials': 'NJ', 'LastName': 'Earland', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Sundar', 'Initials': 'S', 'LastName': 'Ganesan', 'Affiliation': 'Biological Imaging Section, Research Technology Branch, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Ashleigh A', 'Initials': 'AA', 'LastName': 'Sun', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Jenna R E', 'Initials': 'JRE', 'LastName': 'Bergerson', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Silverman', 'Affiliation': 'Department of Pediatrics, Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Petersen', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Martens', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Sandip K', 'Initials': 'SK', 'LastName': 'Datta', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, NIAID, NIH, Bethesda, MD, USA.'}]",Science translational medicine,['10.1126/scitranslmed.aaz8631']
300,32913021,Effect of escitalopram dose and treatment duration on CSF Aβ levels in healthy older adults: A controlled clinical trial.,"OBJECTIVE


To determine whether treatment with escitalopram compared with placebo would lower CSF β-amyloid 42 (Aβ 42 ) levels.
RATIONALE


Serotonin signaling suppresses Aβ 42  in animal models of Alzheimer disease (AD) and young healthy humans. In a prospective study in older adults, we examined dose and treatment duration effects of escitalopram.
METHODS


Using lumbar punctures to sample CSF levels before and after a course of escitalopram treatment, cognitively normal older adults (n = 114) were assigned to placebo, 20 mg escitalopram × 2 weeks, 20 mg escitalopram × 8 weeks, or 30 mg escitalopram × 8 weeks; CSF sampled pretreatment and posttreatment and within-subject percent change in Aβ 42  was used as the primary outcome in subsequent analyses.
RESULTS


An overall 9.4% greater reduction in CSF Aβ 42  was found in escitalopram-treated compared with placebo-treated groups ( p  < 0.001, 95% confidence interval [CI] 4.9%-14.2%,  d  = 0.81). Positive baseline Aβ status (CSF Aβ 42  levels <250 pg/mL) was associated with smaller Aβ 42  reduction ( p  = 0.006, 95% CI -16.7% to 0.5%,  d  = -0.52) compared with negative baseline amyloid status (CSF Aβ 42  levels >250 pg/mL).
CONCLUSIONS


Short-term longitudinal doses of escitalopram decreased CSF Aβ 42  in cognitively normal older adults, the target group for AD prevention.
CLINICALTRIALSGOV IDENTIFIER


NCT02161458.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for cognitively normal older adults, escitalopram decreases CSF Aβ 42 .",2020,An overall 9.4% percentage point greater reduction in CSF Aβ 42  was found in ESC treated compared with placebo treated groups ( p  < 0.001; 95% CI [4.9%-14.2%];  d  = 0.81).,"['older adults', 'healthy older adults', 'cognitively normal older adults (n = 114', ""42  in animal models of Alzheimer's disease (AD) and young healthy humans"", 'cognitively normal older adults, ESC decreases CSF Aβ 42 ', 'cognitively normal older adults']","['ESC treatment', 'ESC', 'placebo, treatment with escitalopram (ESC', 'placebo; 20 mg ESC', 'escitalopram', 'placebo']","['Positive baseline amyloid-beta status ', 'CSF (CSF) amyloid beta 42 (Aβ 42 ) levels', 'CSF Aβ levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0012644', 'cui_str': 'Animal Disease Models'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",114.0,0.0976057,An overall 9.4% percentage point greater reduction in CSF Aβ 42  was found in ESC treated compared with placebo treated groups ( p  < 0.001; 95% CI [4.9%-14.2%];  d  = 0.81).,"[{'ForeName': 'Yvette I', 'Initials': 'YI', 'LastName': 'Sheline', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York. sheline@pennmedicine.upenn.edu.'}, {'ForeName': 'B Joy', 'Initials': 'BJ', 'LastName': 'Snider', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Joanne C', 'Initials': 'JC', 'LastName': 'Beer', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Darsol', 'Initials': 'D', 'LastName': 'Seok', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fagan', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Suckow', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Jin-Moo', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Waligorska', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Korecka', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Irem', 'Initials': 'I', 'LastName': 'Aselcioglu', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Morris', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Shaw', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Cirrito', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}]",Neurology,['10.1212/WNL.0000000000010725']
301,32924685,Does central sensitization affect hyperalgesia after staged bilateral total knee arthroplasty? A randomized controlled trial.,"OBJECTIVE


Osteoarthritis (OA) patients who undergo staged bilateral total knee arthroplasty (TKA) feel postoperative hyperalgesia in the second operated knee compared with the first knee. Ketamine is an important drug for central temporal summation and inhibition of secondary mechanical hyperalgesia. This study investigated whether central sensitization has a significant effect on hyperalgesia after consecutive operations.
METHODS


Seventy-one of 80 OA patients were randomly allocated to the ketamine or saline group. A bolus of ketamine (group K) or saline (group C) (0.5 mg/kg) was injected before induction and at an infusion rate of 3 µg/kg/minute during surgery. A visual analog scale (VAS) was used to assess resting and moving pain and opioid consumption on postoperative days 1, 2, and 3.
RESULTS


The difference in the VAS score between stages 1 and 2 (D V2-V1 ) was higher in the ketamine compared with the saline group. D V2-V1  for movement between the two groups was not inferior for all periods. Ketamine did not show a large analgesic effect on second-operated knee hyperalgesia in staged bilateral TKAs.
CONCLUSIONS


We could not confirm that hyperalgesia was only related to central sensitization with low-dose ketamine. Other factors might be also associated with the hyperexcitability of nociceptive stimuli.Clinical Research Information Service (CRIS) trial registry no: KCT0001481.",2020,"Ketamine did not show a large analgesic effect on second-operated knee hyperalgesia in staged bilateral TKAs.
","['Seventy-one of 80 OA patients', 'Osteoarthritis (OA) patients who undergo']","['ketamine or saline', 'staged bilateral total knee arthroplasty (TKA', 'Ketamine', 'ketamine', 'saline']","['visual analog scale (VAS', 'hyperalgesia', 'VAS score']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.212176,"Ketamine did not show a large analgesic effect on second-operated knee hyperalgesia in staged bilateral TKAs.
","[{'ForeName': 'Hyun Jung', 'Initials': 'HJ', 'LastName': 'Koh', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'In', 'Affiliation': ""Department of Orthopedics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Eun Sung', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Hwang', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Soo Jin', 'Initials': 'SJ', 'LastName': 'Lim', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hue Jung', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",The Journal of international medical research,['10.1177/0300060520938934']
302,32917627,Effects of the re-esterified triglyceride (rTG) form of omega-3 supplements on dry eye following cataract surgery.,"BACKGROUND/AIMS


To evaluate the clinical outcomes of the systemic re-esterified triglyceride (rTG) form of omega-3 fatty acids in patients with dry eye symptoms after cataract surgery.
METHODS


This prospective comparative cohort study comprised 66 patients complaining of new-onset non-specific typical dry eye 1 month after uncomplicated cataract surgery. Subjects were randomly allocated into control and omega-3 groups based on administration of the systemic rTG form of omega-3 fatty acids for 2 months, in addition to use of artificial teardrop. Ocular surface parameters (Schirmer's test, tear break-up time, corneal staining score and matrix metalloproteinase-9 (MMP-9)) and subjective questionnaire results (Ocular Surface Disease Index (OSDI)) and Dry Eye Questionnaire [DEQ]) for dry eye were evaluated before and after omega-3 supplementation.
RESULTS


Two months after omega-3 supplementation, the Oxford score was lower in the omega-3 group than in the control group. There was an improvement of subjective symptom scores of OSDI and DEQ in the omega-3 group (both p<0.05). The ratio of increasing MMP-9 level in the omega-3 group was lower than that in the control group (p=0.027).
CONCLUSION


The rTG form of omega-3 supplementation might be related to reduction of ocular surface inflammation rather than secretion of tears, and it might be effective for non-specific typical dry eye after uncomplicated cataract surgery.
TRIAL REGISTRATION NUMBER


NCT04411615.",2021,"Two months after omega-3 supplementation, the Oxford score was lower in the omega-3 group than in the control group.","['66 patients complaining of new-onset non-specific typical dry eye 1 month after uncomplicated cataract surgery', 'patients with dry eye symptoms after cataract surgery', 'dry eye following cataract surgery']","['systemic re-esterified triglyceride (rTG', 'omega-3 supplements', 'control and omega-3 groups based on administration of the systemic rTG form of omega-3 fatty acids', 'omega-3 fatty acids', 're-esterified triglyceride (rTG']","[""Ocular surface parameters (Schirmer's test, tear break-up time, corneal staining score and matrix metalloproteinase-9 (MMP-9)) and subjective questionnaire results (Ocular Surface Disease Index (OSDI)) and Dry Eye Questionnaire [DEQ"", 'subjective symptom scores of OSDI and DEQ', 'ratio of increasing MMP-9 level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",66.0,0.0130776,"Two months after omega-3 supplementation, the Oxford score was lower in the omega-3 group than in the control group.","[{'ForeName': 'Jongyeop', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Young-Sik', 'Initials': 'YS', 'LastName': 'Yoo', 'Affiliation': ""Ophthalmology, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, Uijeongbu-si, Gyeonggi-do, Korea (the Republic of).""}, {'ForeName': 'Eunhae', 'Initials': 'E', 'LastName': 'Shin', 'Affiliation': 'Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Gyule', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': 'Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Kyungyoon', 'Initials': 'K', 'LastName': 'Shin', 'Affiliation': 'Ophthalmology, Seongnam citizens medical center, Seongnam-si, Gyeonggi-do, Korea (the Republic of).'}, {'ForeName': 'Dong Hui', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of) donghui.lim@samsung.com tychung@skku.edu.'}, {'ForeName': 'Tae-Young', 'Initials': 'TY', 'LastName': 'Chung', 'Affiliation': 'Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-317164']
303,32917473,"Effect of extracorporeal shock wave therapy for burn scar regeneration: A prospective, randomized, double-blinded study.","PURPOSE


This study aimed to investigate the regeneration effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar regeneration using objective measurements.
METHODS


This was a double-blinded, randomized, controlled trial of 48 participants who had undergone autologous split-thickness skin grafting (STSG) with same artificial dermis. The ESWT group (n=25) received shock waves with low-energy flux density (0.05-0.30mJ/mm 2 ). The interval between treatments is a 1-week. The ESWT group also received recommended treatment. The control group (n=23) only received standard treatment. We measured skin characteristics before treatment and after 6 weeks for both groups.
RESULTS


No significant intergroup difference was noted at the initial evaluations (p>0.05). The pre- to post-treatment change in the scar thickness (p=0.03) and erythema (p=0.03), greater reduction was found in the ESWT group than control group. The pre- to post-treatment change in the sebum level (p=0.02), more increase was found in the ESWT group. We found no significant differences in the change measurements between the two groups for melanin levels (p=0.62) and transepidermal water loss (TEWL) (p=0.94). The changes (skin distensibility, biological skin elasticity, gross skin elasticity, and skin viscoelasticity) measured with the Cutometer showed no significant differences between the two groups (p=0.87, p=0.32, p=0.37, and p=0.29, respectively).
CONCLUSION


This is the first report of ESWT on hypertrophic scar after burn using objective tools (melanin, erythema, sebum, TEWL, elasticity and thickness). ESWT has objective beneficial effects on burn-associated scar characteristics.",2021,We found no significant differences in the change measurements between the two groups for melanin levels (p=0.62) and transepidermal water loss (TEWL) (p=0.94).,"['burn scar regeneration', '48 participants who had undergone autologous split-thickness skin grafting (STSG) with same artificial dermis']","['extracorporeal shock wave therapy (ESWT', 'standard treatment', 'extracorporeal shock wave therapy', 'ESWT']","['sebum level', 'transepidermal water loss (TEWL', 'changes (skin distensibility, biological skin elasticity, gross skin elasticity, and skin viscoelasticity', 'scar thickness', 'melanin levels', 'hypertrophic scar', 'hypertrophic scar regeneration', 'skin characteristics']","[{'cui': 'C0036280', 'cui_str': 'Burn scar'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}]",48.0,0.0744747,We found no significant differences in the change measurements between the two groups for melanin levels (p=0.62) and transepidermal water loss (TEWL) (p=0.94).,"[{'ForeName': 'Seung Yeol', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Joo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea.'}, {'ForeName': 'Gi Yeun', 'Initials': 'GY', 'LastName': 'Hur', 'Affiliation': 'Department of plastic and Reconstructive Surgery, Hangang Sacred Heart Hospital, Hallym University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Cheong Hoon', 'Initials': 'CH', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea. Electronic address: pmrseo@hallym.ac.kr.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.08.009']
304,32916151,Synergistic effects of fructose and glucose on lipoprotein risk factors for cardiovascular disease in young adults.,"BACKGROUND


Fructose consumption increases risk factors for cardiometabolic disease. It is assumed that the effects of free sugars on risk factors are less potent because they contain less fructose. We compared the effects of consuming fructose, glucose or their combination, high fructose corn syrup (HFCS), on cardiometabolic risk factors.
METHODS


Adults (18-40 years; BMI 18-35 kg/m 2 ) participated in a parallel, double-blinded dietary intervention during which beverages sweetened with aspartame, glucose (25% of energy requirements (ereq)), fructose or HFCS (25% and 17.5% ereq) were consumed for two weeks. Groups were matched for sex, baseline BMI and plasma lipid/lipoprotein concentrations. 24-h serial blood samples were collected at baseline and at the end of intervention. Primary outcomes were 24-h triglyceride AUC, LDL-cholesterol (C), and apolipoprotein (apo)B. Interactions between fructose and glucose were assessed post hoc.
FINDINGS


145 subjects (26.0 ± 5.8 years; body mass index 25.0 ± 3.7 kg/m 2 ) completed the study. As expected, the increase of 24-h triglycerides compared with aspartame was highest during fructose consumption (25%: 6.66 mmol/Lx24h 95% CI [1.90 to 11.63], P = 0.0013 versus aspartame), intermediate during HFCS consumption (25%: 4.68 mmol/Lx24h 95% CI [-0.18 to 9.55], P = 0.066 versus aspartame) and lowest during glucose consumption. In contrast, the increase of LDL-C was highest during HFCS consumption (25%: 0.46 mmol/L 95% CI [0.16 to 0.77], P = 0.0002 versus aspartame) and intermediate during fructose consumption (25%: 0.33 mmol/L 95% CI [0.03 to 0.63], P = 0.023 versus aspartame), as was the increase of apoB (HFCS-25%: 0.108 g/L 95%CI [0.032 to 0.184], P = 0.001; fructose 25%: 0.072 g/L 95%CI [-0.004 to 0.148], P = 0.074 versus aspartame). The post hoc analyses showed significant interactive effects of fructose*glucose on LDL-C and apoB (both P < 0.01), but not on 24-h triglyceride (P = 0.340).
CONCLUSION


A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS. Thus, the effects of HFCS on lipoprotein risks factors are not solely mediated by the fructose content and it cannot be assumed that glucose is a benign component of HFCS. Our findings suggest that HFCS may be as harmful as isocaloric amounts of pure fructose and provide further support for the urgency to implement strategies to limit free sugar consumption.",2020,A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS.,"['young adults', 'Adults (18-40\u202fyears; BMI 18-35\u202fkg/m 2 ) participated in a']","['consuming fructose, glucose or their combination, high fructose corn syrup (HFCS', 'fructose and glucose', 'Fructose consumption', 'parallel, double-blinded dietary intervention during which beverages sweetened with aspartame, glucose (25% of energy requirements (ereq)), fructose or HFCS', 'HFCS']","['lipoprotein risk factors', '24-h triglycerides', 'LDL-C and apoB', '24-h triglyceride', '24-h serial blood samples', 'LDL-C', '24-h triglyceride AUC, LDL-cholesterol (C), and apolipoprotein (apo)B. Interactions between fructose and glucose']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C2981326', 'cui_str': 'High Fructose Corn Syrup'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement'}]","[{'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",145.0,0.0811716,A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS.,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hieronimus', 'Affiliation': 'Max Rubner-Institut, Institute of Child Nutrition, Karlsruhe, Germany; Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America. Electronic address: bettina.hieronimus@mri.bund.de.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Medici', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Bremer', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of California, Davis, CA, United States of America; Pediatric Growth and Nutrition Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States of America.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Lee', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Marinelle V', 'Initials': 'MV', 'LastName': 'Nunez', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Desiree M', 'Initials': 'DM', 'LastName': 'Sigala', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America; Department of Nutrition, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Keim', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, United States of America; United States Department of Agriculture, Western Human Nutrition Research Center, Davis, CA, United States of America.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Havel', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America; Department of Nutrition, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Kimber L', 'Initials': 'KL', 'LastName': 'Stanhope', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154356']
305,32919893,A 3-Day residential yoga-based program improves education professionals' psychological and occupational health in a single arm trial.,"OBJECTIVE


This study examined changes in psychological and occupational health in urban education professionals after attending a brief yoga-based program.
METHODS


Education professionals from the New York City Department of Education (NYC DOE) who were attending a residential 3-day yoga-based program at Kripalu Center for Yoga & Health were recruited to participate in the study. Measures of psychological and occupational health and health-related behaviors were completed before (baseline), after (post), and two months after the program (follow-up). Paired samples t-tests were used to compare scores between time points.
RESULTS


At post, participants (N = 74) showed improvements in stress, resilience, affect, mindfulness, empowerment, self-compassion, satisfaction with life, work engagement, burnout, exercise, and vegetable intake (all p values < 0.05) compared to baseline. At the follow-up (N = 33), showed improvements in resilience, affect, mindfulness, empowerment, self-compassion, work engagement, and burnout (all p values < 0.05) compared to baseline. There were significant correlations between the degree of home practice of the skills and techniques learned in the program and improvements in multiple measures of psychological and occupational health at follow-up (all p values < 0.05).
CONCLUSIONS


These findings suggest that the yoga-based program improves psychological and occupational health and healthy behaviors in education professionals immediately following the program and up to two-months following the program, however, more data with larger sample sizes are needed to confirm sustained benefits over the longer term.",2021,"At the follow-up (N = 33), showed improvements in resilience, affect, mindfulness, empowerment, self-compassion, work engagement, and burnout (all p values < 0.05) compared to baseline.","['urban education professionals after attending a brief yoga-based program', 'Education professionals from the New York City Department of Education (NYC DOE) who were attending a residential 3-day yoga-based program at Kripalu Center for Yoga & Health were recruited to participate in the study']",['3-Day residential yoga-based program'],"['psychological and occupational health and healthy behaviors', 'psychological and occupational health and health-related behaviors', 'multiple measures of psychological and occupational health', 'resilience, affect, mindfulness, empowerment, self-compassion, work engagement, and burnout', 'stress, resilience, affect, mindfulness, empowerment, self-compassion, satisfaction with life, work engagement, burnout, exercise, and vegetable intake', ""education professionals' psychological and occupational health""]","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237121', 'cui_str': 'Health-related behavior'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C4505268', 'cui_str': 'Employee Engagement'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}]",,0.0171417,"At the follow-up (N = 33), showed improvements in resilience, affect, mindfulness, empowerment, self-compassion, work engagement, and burnout (all p values < 0.05) compared to baseline.","[{'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Dyer', 'Affiliation': 'Kripalu Center for Yoga & Health, Stockbridge MA, USA. Electronic address: natalieleighdyer@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Borden', 'Affiliation': 'Kripalu Center for Yoga & Health, Stockbridge MA, USA.'}, {'ForeName': 'Jeffery A', 'Initials': 'JA', 'LastName': 'Dusek', 'Affiliation': 'Kripalu Center for Yoga & Health, Stockbridge MA, USA.'}, {'ForeName': 'Sat Bir S', 'Initials': 'SBS', 'LastName': 'Khalsa', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston MA, USA.""}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.08.018']
306,32938723,LION-PAW (lymphadenectomy in ovarian neoplasm) sexual function assessment: a prospective sub-study of the LION trial.,"BACKGROUND


There is limited information about the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer.
OBJECTIVE


To evaluate the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer as a sub-protocol of the prospectively randomized LION trial.
METHODS


The Sexual Activity Questionnaire was applied to assess sexual function according to its sub-scales activity, pleasure, and discomfort. The 'orgasm' sub-scale from the Female Sexual Function Index was also added. The questionnaire was administered in combination with the EORTC QLQ-C30 questionnaire at baseline prior surgery, after 6, 12, and 24 months. The primary endpoint was changes in sexual function.
RESULTS


Overall, 495 patients received the questionnaires. 254 (51%) responded at baseline. Of these, 55 (22%) patients were sexually active, 182 (72%) were sexually inactive, and for 17 (7%) patients' data were not available. There was a total of 55/495 (11%) patients at 6 months, 139 (28%) patients at 12 months, and 81 (16%) patients at 24 months. Median age was 60.5 years (range 21.4-75.8). At baseline, sexually active responders were significantly younger (median age 51.5 years,) than sexually inactive responders (median age 61.8 years) and tended to have a better performance status. Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (p<0.001); however, the surgical variable, lymphadenectomy, did not have any impact on this. The orgasm sub-scale showed diverging results with a deterioration from baseline to 12 months in the lymphadenectomy group compared with the no-lymphadenectomy group (p=0.02).
CONCLUSION


The majority of patients were sexually inactive; however, in those who were sexually active, pain during intercourse was worse at 12 months. In addition, the orgasm sub-scale demonstrated worse results in patients who underwent complete lymphadenectomy. The study suggests that surgery in the retroperitoneal space may influence sexual function.",2020,"Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (p<0.001); however, the surgical variable, lymphadenectomy, did not have any impact on this.","['patients with advanced ovarian cancer', ""55 (22%) patients were sexually active, 182 (72%) were sexually inactive, and for 17 (7%) patients' data were not available"", 'Median age was 60.5 years (range 21.4-75.8', '495 patients received the questionnaires', 'sexually active responders were significantly younger (median age 51.5 years,) than sexually inactive responders (median age 61.8 years']","['radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy', 'LION-PAW (lymphadenectomy']","['sexual function', 'sexual function according to its sub-scales activity, pleasure, and discomfort', 'Discomfort evaluated as dryness of the vagina and pain during sexual intercourse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0023756', 'cui_str': 'Panthera leo'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",,0.0418331,"Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (p<0.001); however, the surgical variable, lymphadenectomy, did not have any impact on this.","[{'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hasenburg', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Center, Mainz, Germany Annette.Hasenburg@unimedizin-mainz.de.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynecology with Center for Oncological Surgery, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, New Hampshire, USA.'}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Lampe', 'Affiliation': 'Department of Gynecology and Obstetrics, Kaiserswerther Diakonie, Duesseldorf, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reuss', 'Affiliation': 'Coordinating Centre for Clinical Trials, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schmalfeld', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ludwig-Maximilians-University Munich, München, Bayern, Germany.'}, {'ForeName': 'Antje Kristina', 'Initials': 'AK', 'LastName': 'Belau', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Bossart', 'Affiliation': 'Department of Gynecology and Obstetrics, University Medical Center Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillemanns', 'Affiliation': 'Department of Gynecology and Obstetrics, Medizinische Hochschule, Hannover, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Petry', 'Affiliation': 'Department of Gynecology and Obstetrics, Klinikum Wolfsburg, Wolfsburg, Niedersachsen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, KEM, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Herwig', 'Affiliation': 'Department of Gynecology and Obstetrics, Albertinen-Hospital Hamburg, Hamburg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': 'Department of Gynecology and Obstetrics, Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gropp-Meier', 'Affiliation': 'Department of Gynecology and Obstetrics, St. Elisabethenhospital, Ravensburg, Baden-Württemberg, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Hanf', 'Affiliation': 'Department of Gynecology and Obstetrics, Klinikum Fürth, Fürth, Bayern, Germany.'}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Greimel', 'Affiliation': 'Clinical Psychology Unit, Medical University Graz, Graz, Steiermark, Austria.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Wagner', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Gießen and Marburg GmbH Site Marburg, Marburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, KEM, Kliniken Essen Mitte, Essen, Germany.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001551']
307,32927285,"Open-label titration of apomorphine sublingual film in patients with Parkinson's disease and ""OFF"" episodes.","INTRODUCTION


The efficacy and safety of apomorphine sublingual film (APL-130277; APL) for the on-demand treatment of ""OFF"" episodes associated with Parkinson's disease (PD) was demonstrated in a double-blind trial. Herein we describe the ability of patients to receive effective and tolerable APL dose titration during the open-label titration phase.
METHODS


Adult patients with levodopa-responsive PD and ""OFF"" episodes were enrolled. In practically defined ""OFF,"" patients were observed for a FULL ""ON"" after their usual morning carbidopa/levodopa (CD/LD) dose and then after titration with APL following each increasing dose (10-35 mg). Antiemetic medication was administered for 3 days before initiation of titration and was continued throughout titration. Motor responses were evaluated predose and postdose using Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. Safety outcomes were evaluated.
RESULTS


Among 141 patients who enrolled in the study and received APL during open-label titration, 109 (77.3%) achieved a FULL ""ON"" (66.1% at 10-20 mg) and 10 did not. Patients who successfully completed APL dose titration tended to be younger, had a longer mean time since PD diagnosis, and had lower levodopa requirements than those who discontinued during titration for any reason. Change in MDS-UPDRS Part III scores from predose to 30 min postdose after titration with the effective dose of APL (n = 109) was similar across all dose groups. In a post hoc analysis, the magnitude of motor response with APL was ~2-fold higher than with CD/LD 15 min postdose, and the observed peak response occurred earlier with APL than with the trend seen for CD/LD (45 vs 90 min, respectively). Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%). Twelve patients discontinued due to TEAEs during APL dose titration, most commonly (≥2%) because of dizziness (2.8%), nausea (2.1%), and somnolence (2.1%).
CONCLUSION


Among eligible patients with PD and ""OFF"" episodes who had their APL dose successfully titrated to an effective and tolerable level, most were able to do so within the first 3 titrated doses but some required further dose escalations. The use of APL can provide benefit for the treatment of ""OFF"" episodes.",2020,"Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%).","['patients with Parkinson\'s disease and ""OFF"" episodes', '141 patients who enrolled in the study and received', 'OFF"" episodes associated with Parkinson\'s disease (PD', 'eligible patients with PD and ""OFF"" episodes who had their', 'Adult patients with levodopa-responsive PD and ""OFF"" episodes were enrolled']","['apomorphine sublingual film', 'APL', 'apomorphine sublingual film (APL-130277; APL', 'FULL ""ON']","['peak response', ""predose and postdose using Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'Change in MDS-UPDRS Part III scores', 'nausea', 'magnitude of motor response with APL', 'longer mean time since PD diagnosis', 'somnolence', 'dizziness', 'levodopa requirements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}]","[{'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}]",141.0,0.03312,"Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%).","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Hui', 'Affiliation': 'Keck School of Medicine of USC, University of Southern California, Los Angeles, CA, United States. Electronic address: Jennifer.hui@med.usc.edu.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Fox', 'Affiliation': 'University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada; Division of Neurology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Neeson', 'Affiliation': 'Sunovion Pharmaceuticals Canada Inc., Mississauga, Ontario, Canada.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Bhargava', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pappert', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Navia', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.08.028']
308,32927371,Neural affective mechanisms associated with treatment responsiveness in veterans with PTSD and comorbid alcohol use disorder.,"Post-traumatic stress disorder (PTSD) is associated with neuro-physiological abnormalities reflecting increased anticipatory anxiety and reactivity to traumatic cues. It remains unclear whether neural mechanisms associated with PTSD treatment responsiveness, i.e. hyperactivation of the affective salience network in the brain, extend to a comorbid PTSD and substance use disorder population. Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD) were randomly assigned to either prolonged exposure or a non-exposure based treatment. They completed an affective anticipation task while undergoing fMRI, immediately prior and after completing treatment. After controlling for type and length of treatment, larger reduction of PTSD symptoms was associated with decreased anticipatory activation to negative trauma-related cues in the right pre-Supplementary Motor Area (pre-SMA), a region associated with emotion regulation. Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region. Our findings suggest that post-treatment reductions in anticipatory reactivity to trauma-related cues in the pre-SMA and para-hippocampal area are associated with larger PTSD symptom reduction in individuals with co-occurring PTSD and AUD. These results may offer neurofeedback training targets as an alternative to or enhancement of other PTSD treatment modalities in this population.",2020,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","['veterans with PTSD and comorbid alcohol use disorder', 'Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD', 'Post-traumatic stress disorder (PTSD']",['prolonged exposure or a non-exposure based treatment'],"['PTSD symptoms', 'PTSD severity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",31.0,0.00943451,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","[{'ForeName': 'Katia M', 'Initials': 'KM', 'LastName': 'Harlé', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States. Electronic address: kharle@ucsd.edu.'}, {'ForeName': 'Alan N', 'Initials': 'AN', 'LastName': 'Simmons', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Andrea D', 'Initials': 'AD', 'LastName': 'Spadoni', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111172']
309,32946039,Wake-Promoting Effect of Bloodletting Puncture at Hand Twelve Jing-Well Points in Acute Stroke Patients: A Multi-center Randomized Controlled Trial.,"OBJECTIVE


To assess the effect and safety of bloodletting puncture at hand twelve Jing-Well points (HTWPs) in acute stroke patients with conscious disturbance.
METHODS


In this multi-center and randomized controlled trial, 360 patients suffered from ischemic or hemorrhagic stroke with conscious disturbance within 48 h from the onset of symptom were divided into bloodletting (180 cases) and control (180 cases) groups using a block randomization. Patients in both groups received routine Western medicine, and patients in the bloodletting group received additional bloodletting puncture at HTWPs on admission immediately before conventional treatment. The primary outcome measure was Glasgow Coma Scale (GCS) score and the secondary outcomes included blood pressure, respiratory rate and pulse rate. All variables were evaluated at baseline (before bloodletting), 0 (after bloodletting immediately), 15, 30, 50 and 80 min post bloodletting.
RESULTS


At 80 min post bloodletting, the proportion of patients with improved consciousness in the bloodletting group was greater than the control group (P<0.05). In the separate analysis of moderate consciousness disturbance subgroup, bloodletting therapy benefited ischemic patients, and improved the eye and language response of GCS score at 15, 30, 50, 80 min post bloodletting (P<0.05 or P<0.01). No significant differences were observed regarding the secondary outcomes between two groups (P>0.05).
CONCLUSION


The bloodletting puncture at HTWPs was safe and could improve conscious levels of ischemic stroke patients, highlighting a first-aid intervention for acute stroke. (Registration No. ChiCTR-INR-16009530).",2021,"At 80 min post bloodletting, the proportion of patients with improved consciousness in the bloodletting group was greater than the control group (P<0.05).","['acute stroke patients with conscious disturbance', 'Acute Stroke Patients', '360 patients suffered from ischemic or hemorrhagic stroke with conscious disturbance within 48 h from the onset of symptom were divided into bloodletting (180 cases) and control (180 cases) groups using a block randomization']","['bloodletting puncture at hand twelve Jing-Well points (HTWPs', 'routine Western medicine', 'Bloodletting Puncture at Hand', 'bloodletting group received additional bloodletting puncture at HTWPs']","['eye and language response of GCS score', 'proportion of patients with improved consciousness', 'Glasgow Coma Scale (GCS) score', 'blood pressure, respiratory rate and pulse rate']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}]",360.0,0.159877,"At 80 min post bloodletting, the proportion of patients with improved consciousness in the bloodletting group was greater than the control group (P<0.05).","[{'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Yu', 'Affiliation': ""Department of Traditional Chinese Medicine, Xijing Hospital, the Air Force Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Zhi-Fang', 'Initials': 'ZF', 'LastName': 'Xu', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Acupuncture and Moxibustion, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Zhi-Liang', 'Initials': 'ZL', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture and Moxibustion, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300150, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China.'}, {'ForeName': 'Zhen-Guo', 'Initials': 'ZG', 'LastName': 'Wang', 'Affiliation': ""The Third Department of Encephalopathy, Xi'an Encephalopathy Hospital of Traditional Chinese Medicine, Xi'an, 710032, China.""}, {'ForeName': 'Ze-Lin', 'Initials': 'ZL', 'LastName': 'Chen', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China.'}, {'ForeName': 'Xing-Fang', 'Initials': 'XF', 'LastName': 'Pan', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China. panxingfang@163.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China. guoyi_2016@126.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3093-8']
310,32953229,Long-Term Efficacy of Subcutaneous C1 Inhibitor in Pediatric Patients with Hereditary Angioedema.,"Background:  Hereditary angioedema (HAE) due to C1 inhibitor (C1INH) deficiency is characterized by recurrent attacks of edema of the skin and mucosal tissues. Symptoms usually present during childhood (mean age at first attack, 10 years). Earlier symptom onset may predict a more severe disease course. Subcutaneous (SC) C1INH is indicated for routine prophylaxis to prevent HAE attacks in adolescents and adults. We analyzed the long-term efficacy of C1INH (SC) in subjects ≤17 years old treated in an open-label extension (OLE) of the pivotal phase III Clinical Study for Optimal Management of Preventing Angioedema with Low-Volume Subcutaneous C1 Inhibitor Replacement Therapy (COMPACT) trial.  Methods:  Eligible subjects (age ≥6 years, with ≥4 attacks over 2 consecutive months before entry into the OLE or placebo-controlled COMPACT trial) were treated with C1INH (SC) 40 or 60 IU/kg twice weekly for 52-140 weeks. Subgroup analyses by age (≤17 vs. >17 years) were performed for key efficacy endpoints.  Results:  Ten subjects were ≤17 years old [mean (range) age, 13.3 (8-16) years, 3 subjects <12 years old; exposure range, 51-133 weeks]. All 10 pediatric subjects experienced ≥50% reduction (mean, 93%) in number of attacks versus the prestudy period, with a 97% reduction in the median number of attacks/month (0.11). All subjects had <1 attack/4-week period and 4 had <1 attack/year (1 subject was attack free). No subject discontinued treatment due to a treatment-related adverse event.  Conclusions:  Data from pediatric subjects treated with C1INH (SC) for up to 2.55 years and adult subjects revealed similar efficacy. C1INH (SC) is effective and well tolerated as long-term prophylaxis in children, adolescents, and adults with HAE.",2020,"All 10 pediatric subjects experienced ≥50% reduction (mean, 93%) in number of attacks versus the prestudy period, with a 97% reduction in the median number of attacks/month (0.11).","['Pediatric Patients with Hereditary Angioedema', 'Results:  Ten subjects were ≤17 years old [mean (range) age, 13.3 (8-16) years, 3 subjects <12 years old; exposure range, 51-133 weeks', 'adolescents and adults', 'Subgroup analyses by age (≤17 vs. >17 years', 'Eligible subjects (age ≥6 years, with ≥4 attacks over 2 consecutive months before entry into the OLE or placebo-controlled COMPACT trial', 'subjects ≤17 years old treated in an open-label extension (OLE) of the pivotal phase III Clinical Study for Optimal Management of Preventing Angioedema with Low-Volume Subcutaneous C1 Inhibitor Replacement Therapy (COMPACT) trial', 'All subjects had <1 attack/4-week period and 4 had <1 attack/year (1 subject was attack free', 'children, adolescents, and adults with HAE']","['C1INH (SC', 'Subcutaneous C1 Inhibitor', 'Subcutaneous (SC) C1INH']",['number of attacks'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0002994', 'cui_str': 'Angioedema'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",10.0,0.0237439,"All 10 pediatric subjects experienced ≥50% reduction (mean, 93%) in number of attacks versus the prestudy period, with a 97% reduction in the median number of attacks/month (0.11).","[{'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': 'University of California at Irvine, Irvine, California, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Caballero', 'Affiliation': 'Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Iftikhar', 'Initials': 'I', 'LastName': 'Hussain', 'Affiliation': 'Vital Prospects Clinical Research Institute, Tulsa, Oklahoma, USA.'}, {'ForeName': 'Avner', 'Initials': 'A', 'LastName': 'Reshef', 'Affiliation': 'Barzilai Medical Centre, Ashkelon, Israel.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Birmingham, Alabama, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Baker Allergy, Asthma and Dermatology Research Center, Portland, Oregon, USA.'}, {'ForeName': 'Lawrence B', 'Initials': 'LB', 'LastName': 'Schwartz', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cicardi', 'Affiliation': 'University of Milan, Milan, Italy.'}, {'ForeName': 'Subhransu', 'Initials': 'S', 'LastName': 'Prusty', 'Affiliation': 'CSL Behring GmbH Standort Behringwerke Marburg, Marburg, Germany.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Feuersenger', 'Affiliation': 'CSL Behring GmbH Standort Behringwerke Marburg, Marburg, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Pragst', 'Affiliation': 'CSL Behring GmbH Standort Behringwerke Marburg, Marburg, Germany.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Manning', 'Affiliation': 'Medical Research of Arizona, Scottadale, Arizona, USA.'}]","Pediatric allergy, immunology, and pulmonology",['10.1089/ped.2020.1143']
311,32926502,The Mediterranean diet increases glucagon-like peptide 1 and oxyntomodulin compared with a vegetarian diet in patients with type 2 diabetes: A randomized controlled cross-over trial.,"AIM


To compare a Mediterranean diet (MED) with a high-fibre vegetarian diet (HFV) in terms of hunger-satiety perception through post-prandial assessment of appetite-related hormones glucagon-like peptide 1 (GLP-1) and oxyntomodulin, as well as self-rated visual analogue scale (VAS) quantification, in overweight/obese subjects with type 2 diabetes (T2D).
MATERIALS AND METHODS


Twelve T2D subjects (Male to female ratio = 7:5), mean age 63 ± 8.5 years, were enrolled in a randomized, controlled, crossover study. Participants consumed an MED meal as well as an isocaloric meal rich in complex carbohydrate as well as an isocaloric MED meal in two different visits with a 1-week washout period between the two visits. Appetite ratings, glucose/insulin, and gastrointestinal hormone concentrations were measured at fasting and every 30' until 210' following meal consumption.
RESULTS


GLP-1 and oxyntomodulin levels were significantly higher following MED meal compared with HFV meals (210' area under the curve, p < 0.022 and p < 0.023, respectively). Both MED and HFV meal resulted in a biphasic pattern of GLP-1 and oxyntomodulin, although MED meal was related to a delayed, significantly higher second GLP-1 peak at 150' compared with that of HFV meal (p < 0.05). MED meal was related to lower glucose profile compared with HFV meal (p < 0.039), whereas we did not observe significant changes in terms of self-reported VAS scores and insulin trend.
CONCLUSIONS


In T2D overweight/obese subjects, an MED meal is more effective than a HFV meal in terms of post-prandial plasma glucose homoeostasis and GLP-1 and oxyntomodulin release. These changes were not confirmed by VAS appetite self-assessment over a 210' period.",2021,"MED meal was related to lower glucose profile compared with HFV meal (P <0.039), whereas we did not observe significant changes in terms of self-reported VAS scores and insulin trend.
","['T2D overweight/obese subjects', 'Twelve T2D subjects (Male to female ratio = 7:5), mean age 63 ± 8.5 years', 'Patients with Type 2 Diabetes', 'overweight/obese subjects with type-2 diabetes (T2D']","['high fiber vegetarian (HFV) meal rich in complex carbohydrate', 'Mediterranean Diet', 'Mediterranean dietetic pattern with a vegetarian pattern']","['second GLP-1 peak', 'GLP-1 and Oxyntomodulin levels', 'biphasic pattern of GLP-1 and Oxyntomodulin, although MED meal', 'Appetite ratings, glucose/insulin and gastrointestinal hormone concentrations', 'self-reported VAS scores and insulin trend']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0042441', 'cui_str': 'Vegetarian'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0556154', 'cui_str': 'Complex carbohydrate'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0086379', 'cui_str': 'Glicentin (33-69)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0040833', 'cui_str': 'trends'}]",12.0,0.0209876,"MED meal was related to lower glucose profile compared with HFV meal (P <0.039), whereas we did not observe significant changes in terms of self-reported VAS scores and insulin trend.
","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Mauro', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Tuccinardi', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Mikiko', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Experimental Medicine, Section of Medical Pathophysiology, Food Science and Endocrinology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Del Toro', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Lavinia', 'Initials': 'L', 'LastName': 'Monte', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Giorgino', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Rampa', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Rossini', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Kyanvash', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Soare', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Rosati', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Piccoli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Nicoli', 'Initials': 'N', 'LastName': 'Napoli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Fioriti', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pozzilli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Yeganeh M', 'Initials': 'YM', 'LastName': 'Khazrai', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Manfrini', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3406']
312,32935565,Assessment of the Contrast-Enhanced Ultrasound in Percutaneous Nephrolithotomy for the Treatment of Patients with Nondilated Collecting System.,"Purpose:  To investigate the clinical value of contrast-enhanced ultrasound (CEUS) in percutaneous nephrolithotomy (PCNL) for kidney stone patients without hydronephrosis.  Methods:  Patients with nondilated collecting system kidney stones who underwent PCNL between October 2018 and December 2019 at our hospital were enrolled in this study. Patients who met the inclusion criteria were randomized into two groups: a CEUS-guided PCNL group and a conventional ultrasound (US)-guided PCNL group. The operation results of the two groups were compared, including the number of attempts for effective puncture, duration to effective puncture, stone clearance rate, blood loss, postoperative complications, and hospital stay.  Results:  Fifty-six patients with a nondilated collecting system who underwent PCNL for 60 kidneys were included in this study, including 4 patients who underwent bilateral PCNL due to bilateral renal stones. There were 30 kidneys in each group. All patients successfully underwent PCNL. The CEUS-guided PCNL group had more accurate punctures, with a higher effective rate of one puncture and shorter puncture time. There was no statistically significant difference in stone clearance rate between the two groups. Four cases of double channels were established in the conventional US-guided PCNL group, while there was only one case in the CEUS-guided PCNL group. In the CEUS-guided PCNL group, most cases (96.7%, 29/30) had no or only mild complications, which were significantly better than the conventional US-guided PCNL group (76.7%, 23/30). The mean postoperative hemoglobin loss in the CEUS-guided PCNL group was 9.5 (range 1-25) g/L, which was significantly lower than 15.5 (range 5-52) g/L in the conventional US-guided PCNL group.  Conclusion:  The CEUS technique can improve visibility of the nondilated renal collecting system, facilitate selection of suitable calix, and identify renal calix fornix. It also benefits needle placement in patients with a nondilated collecting system.",2021,"The CEUS-guided PCNL group had more accurate punctures, with a higher successful rate of one puncture and shorter puncture time.","['Fifty-six patients with a nondilated collecting system who underwent PCNL for sixty kidneys', 'Patients with nondilated collecting system kidney stones who underwent PCNL between October 2018 and December 2019 at our hospital were enrolled in this study', 'kidney stone patients without hydronephrosis', 'Patients who met the inclusion criteria', 'patients with a nondilated collecting system', 'Patients with Nondilated Collecting System']","['CEUS-guided PCNL group and a conventional ultrasound (US)-guided PCNL group', 'contrast-enhanced ultrasound (CEUS', 'Contrast-Enhanced Ultrasound in Percutaneous Nephrolithotomy', 'PCNL', 'percutaneous nephrolithotomy (PCNL', 'bilateral PCNL']","['mild complications', 'number of attempts for successful puncture, duration to successful puncture, stone clearance rate, blood loss, postoperative complications and hospital stay', 'successful rate of one puncture and shorter puncture time', 'mean postoperative hemoglobin loss', 'bilateral renal stones', 'stone clearance rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]",56.0,0.0184341,"The CEUS-guided PCNL group had more accurate punctures, with a higher successful rate of one puncture and shorter puncture time.","[{'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Zonglai', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Xiaozhan', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Ultrasound, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ai', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Ziqiu', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Du', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}]",Journal of endourology,['10.1089/end.2020.0564']
313,32937192,"Oxytocin effects on the cognition of women with postpartum depression: A randomized, placebo-controlled clinical trial.","BACKGROUND


One of the most common mental disorders in the perinatal period is postpartum depression (PPD), which is associated with impaired emotional functioning due to alterations in different cognitive aspects including thought and facial emotion recognition (FER). Emotional impairments may affect the interaction and care offered to infants and their later development and therefore interventions with potential to minimize impairments associated with PPD are opportune. Oxytocin (OXT) was shown to have therapeutic properties associated with the promotion of affiliative and pro-social behaviors in different mental disorders. Few studies have assessed its therapeutic potential in PPD.
OBJECTIVES


To assess the effects of the acute administration of intranasal OXT (24 IU) on FER of baby faces and negative thoughts after delivery in mothers with and without PPD.
METHODS


We conducted a randomized double-blind, placebo-controlled trial with a crossover design involving mothers with PPD (N = 20) and without PPD (N = 35) in the puerperium. Participants completed a static task of FER of baby faces and a questionnaire of post-natal negative thoughts.
RESULTS


Mothers with PPD had increased scores of negative thoughts about motherhood/infants, but no impairments in FER, when compared to healthy mothers. OXT had no effects on the rates of correct judgments or response times in the FER task, but was associated with response biases to facial happiness and the reduction of negative thoughts in mothers with PPD.
DISCUSSION/CONCLUSION


OXT may have positive effects on maternal affiliative behavior, maternal care, and mother-infant interactions as suggested by changes found in different cognitive aspects, thus minimizing the deleterious effects of PPD on child development.",2021,"RESULTS


Mothers with PPD had increased scores of negative thoughts about motherhood/infants, but no impairments in FER, when compared to healthy mothers.","['women with postpartum depression', 'mothers with and without PPD', 'mothers with PPD', 'mothers with PPD (N\u202f=\u202f20) and without PPD (N\u202f=\u202f35) in the puerperium']","['intranasal OXT', 'OXT', 'placebo', 'Oxytocin', 'Oxytocin (OXT']","['rates of correct judgments or response times', 'FER of baby faces and negative thoughts', 'scores of negative thoughts', 'static task of FER of baby faces and a questionnaire of post-natal negative thoughts']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0034042', 'cui_str': 'Puerperium'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1142075', 'cui_str': 'Negative thoughts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0454729', 'cui_str': 'Natal'}]",,0.382587,"RESULTS


Mothers with PPD had increased scores of negative thoughts about motherhood/infants, but no impairments in FER, when compared to healthy mothers.","[{'ForeName': 'Mariana Fortunata', 'Initials': 'MF', 'LastName': 'Donadon', 'Affiliation': 'Medical School of Ribeirão Preto, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Martin-Santos', 'Affiliation': 'Servicio de Psiquiatria y Psicología, Hospital Clinic, Universidad de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'L Osório', 'Affiliation': 'Medical School of Ribeirão Preto, São Paulo University, Ribeirão Preto, SP, Brazil; National Institute for Science and Technology (INCT-TM, CNPq), Brasília, Brazil. Electronic address: flaliosorio@gmail.com.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110098']
314,32941462,Provider anticipation and experience of patient reaction when deprescribing guideline discordant inhaled corticosteroids.,"INTRODUCTION


Despite evidence of possible patient harm and substantial costs, medication overuse is persistent. Patient reaction is one potential barrier to deprescribing, but little research has assessed this in specific instances of medication discontinuation. We sought to understand Veteran and provider experience when de-implementing guideline-discordant use of inhaled corticosteroids (ICS) in those with mild-to-moderate chronic obstructive pulmonary disease (COPD).
METHODS


We conducted a mixed-methods analysis in a provider-randomized quality improvement project testing a proactive electronic-consultation from pulmonologists recommending ICS discontinuation when appropriate. PCPs at two Veterans Health Administration healthcare systems were included. We completed interviews with 16 unexposed providers and 6 intervention-exposed providers. We interviewed 9 patients within 3 months after their PCP proposed ICS discontinuation. We conducted inductive and deductive content analysis of qualitative data to explore an emergent theme of patient reaction. Forty-eight PCPs returned surveys (24 exposed and 24 unexposed, response rate: 35%).
RESULTS


The unexposed providers anticipated their patients might resist ICS discontinuation because it seems counterintuitive to stop something that is working, patient's fear of worsening symptoms, or if the prescription was initiated by another provider. Intervention-exposed providers reported similar experiences in post-intervention interviews. Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies. This was echoed by intervention-exposed providers who had successfully discontinued an ICS. Veterans reported acceding to their providers out of trust or deference to their advanced training, even after describing an ICS as a 'security blanket'. Our survey findings supported the subthemes from our interviews. Among providers who proposed discontinuation of an ICS, 76% reported that they were able to discontinue it or switch to another more appropriate medication.
CONCLUSIONS


While PCPs anticipated that patients would resist discontinuing an ICS, interviews with patient and intervention-exposed PCPs along with surveys suggest that patients were receptive to this change.",2020,"Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies.","['16 unexposed providers and 6 intervention-exposed providers', 'those with mild-to-moderate chronic obstructive pulmonary disease (COPD']",['inhaled corticosteroids (ICS'],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],9.0,0.0455836,"Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies.","[{'ForeName': 'Toral J', 'Initials': 'TJ', 'LastName': 'Parikh', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Krysttel C', 'Initials': 'KC', 'LastName': 'Stryczek', 'Affiliation': 'VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gillespie', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'George G', 'Initials': 'GG', 'LastName': 'Sayre', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Feemster', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Edmunds', 'Initials': 'E', 'LastName': 'Udris', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Majerczyk', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Seppo T', 'Initials': 'ST', 'LastName': 'Rinne', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'Renda Soylemez', 'Initials': 'RS', 'LastName': 'Wiener', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Helfrich', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}]",PloS one,['10.1371/journal.pone.0238511']
315,32946618,"Expression of HGF, pMet, and pAkt is related to benefit of radiotherapy after breast-conserving surgery: a long-term follow-up of the SweBCG91-RT randomised trial.","Experimental studies suggest that hepatocyte growth factor (HGF) and its transmembrane tyrosine kinase receptor, Met, in part also relying on Akt kinase activity, mediate radioresistance. We investigated the importance of these biomarkers for the risk of ipsilateral breast tumour recurrence (IBTR) after adjuvant radiotherapy (RT) in primary breast cancer. HGF, phosphorylated Met (pMet) and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT. HGF was evaluated in the stroma (HGF str  ); pMet in the membrane (pMet mem  ); HGF, pMet and pAkt in the cytoplasm (HGF cyt  , pMet cyt  , pAkt cyt  ); and pAkt in the nucleus (pAkt nuc  ). The prognostic and treatment predictive effects were evaluated to primary endpoint IBTR as first event during the first 5 years. Patients with tumours expressing low levels of HGF cyt  and pMet cyt  and high levels of pAkt nuc  derived a larger benefit from RT [hazard ratio (HR): 0.11 (0.037-0.30), 0.066 (0.016-0.28) and 0.094 (0.028-0.31), respectively] compared to patients with high expression of HGF cyt  and pMet cyt  , and low pAkt nuc  [HR: 0.36 (0.19-0.67), 0.35 (0.20-0.64) and 0.47 (0.32-0.71), respectively; interaction analyses: P = 0.052, 0.035 and 0.013, respectively]. These differences remained in multivariable analysis when adjusting for patient age, tumour size, histological grade, St Gallen subtype and systemic treatment (interaction analysis, P-values: 0.085, 0.027, and 0.023, respectively). This study suggests that patients with immunohistochemically low HGF cyt  , low pMet cyt  and high pAkt nuc  may derive an increased benefit from RT after breast-conserving surgery concerning the risk of developing IBTR.",2020,"HGF, phosphorylated Met (pMet), and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1,004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT.","['primary breast cancer', 'patients with immunohistochemically low HGF cyt  , low pMet cyt  , and high pAkt nuc']","['breast-conserving therapy, with or without adjuvant RT', 'radiotherapy', 'adjuvant radiotherapy (RT', 'hepatocyte growth factor (HGF']",['HGF'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}]","[{'cui': 'C0062534', 'cui_str': 'Scatter Factor'}]",,0.0359245,"HGF, phosphorylated Met (pMet), and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1,004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Veenstra', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Fredrika', 'Initials': 'F', 'LastName': 'Killander', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Niméus', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Stål', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}]",Molecular oncology,['10.1002/1878-0261.12803']
316,32977220,Phase I/II trial of sequential treatment of nab-paclitaxel in combination with gemcitabine followed by modified FOLFOX chemotherapy in patients with untreated metastatic exocrine pancreatic cancer: Phase I results.,"BACKGROUND


Although occasioned through different mechanisms, the potential neurotoxicity and also haematological toxicity of nab-paclitaxel and oxaliplatin-based chemotherapy regimen were studied in this trial, which aimed to determine the maximum-tolerated dose (MTD) and to evaluate safety and efficacy of the combination in a sequential regimen of nab-paclitaxel, gemcitabine (GEM) and modified FOLFOX (mFOLFOX) in untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
MATERIALS AND METHODS


Treatment consisted of nab-paclitaxel (125/100 mg/m 2 ) plus GEM (1000/800 mg/m 2 ) on days 1, 8 and 15, followed by mFOLFOX (oxaliplatin [85/75/65 mg/m 2 ], 5-FU bolus [400/300/200 mg/m 2 ], 5-FU infusion [2400/2000/1600 mg/m 2 ]) on day 28, of a 42-day cycle. Patients were enrolled at the highest dose level with a subsequent 3 + 3 dose de-escalation plan.
RESULTS


Eleven patients (median age = 61, 64% with performance status [PS] = 1) were eligible. All patients received the highest dose level. No de-escalation was needed. A dose-limiting toxicity was reported, an upper gastrointestinal haemorrhage. The MTD was nab-paclitaxel 125 mg/m 2 , GEM 1000 mg/m 2 , oxaliplatin 85 mg/m 2 , 5-FU bolus 400 mg/m 2  and 5-FU infusion 2400 mg/m 2 . Common all-grade toxicities were neutropenia (73%), anaemia (55%), thrombocytopenia (55%) and asthenia (55%). Other relevant toxicities were paraesthesia (46%), nausea (36%), dysesthesia (27%) and pyrexia (27%). Objective response rate was 50% and disease control rate was 80%.
CONCLUSIONS


The regimen of nab-paclitaxel plus GEM followed by mFOLFOX showed favourable safety and tolerability profiles with significant anti-tumor activity. More data are being achieved in a randomised phase II trial, to confirm efficacy rates and dismiss long-term neurotoxicity concerns regarding the sequencing of nab-paclitaxel and oxaliplatin.",2020,No de-escalation was needed.,"['untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC', 'patients with untreated metastatic exocrine pancreatic cancer', 'Eleven patients (median age\xa0=\xa061, 64% with performance status [PS]\xa0=\xa01) were eligible']","['gemcitabine followed by modified FOLFOX chemotherapy', '5-FU infusion 2400', 'nab-paclitaxel', 'paclitaxel', 'paclitaxel and oxaliplatin-based chemotherapy', 'oxaliplatin', 'oxaliplatin 85\xa0mg/m 2 , 5-FU bolus 400', 'nab-paclitaxel plus GEM', 'mFOLFOX (oxaliplatin [85/75/65\xa0mg/m 2 ], 5-FU bolus [400/300/200\xa0mg/m 2 ], 5-FU infusion', 'nab-paclitaxel, gemcitabine (GEM) and modified FOLFOX (mFOLFOX', 'nab-paclitaxel (125/100\xa0mg/m 2 ) plus GEM']","['disease control rate', 'favourable safety and tolerability profiles', 'thrombocytopenia', 'asthenia', 'nausea', 'Objective response rate', 'neutropenia', 'anaemia', 'pyrexia']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0346648', 'cui_str': 'Malignant tumor of exocrine pancreas'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",1.0,0.0271254,No de-escalation was needed.,"[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Carrato', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; University of Alcalá. Alcalá de Henares, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain; CIBERONC, Madrid. Spain. Electronic address: acarrato@telefonica.net.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Vieitez', 'Affiliation': 'University Central Hospital of Asturias, Oviedo. Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Benavides', 'Affiliation': 'University Regional Hospital and Virgen de la Victoria, Málaga. Spain; IBIMA, Málaga. Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Rodriguez-Garrote', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain; CIBERONC, Madrid. Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Castillo', 'Affiliation': 'University Central Hospital of Asturias, Oviedo. Spain.'}, {'ForeName': 'Gema Durán', 'Initials': 'GD', 'LastName': 'Ogalla', 'Affiliation': 'University Regional Hospital and Virgen de la Victoria, Málaga. Spain; IBIMA, Málaga. Spain.'}, {'ForeName': 'Laura García', 'Initials': 'LG', 'LastName': 'Bermejo', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; University of Alcalá. Alcalá de Henares, Madrid. Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Ruiz de Mena', 'Affiliation': 'Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD).'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Guillén-Ponce', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Aranda', 'Affiliation': 'CIBERONC, Madrid. Spain; IMIBIC, Córdoba. Spain; Reina Sofia University Hospital, Córdoba. Spain; University of Córdoba, Córdoba. Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.07.035']
317,32974894,Transient stent placement versus tubeless procedure after ureteroscopy retrograde surgery stone extraction (Fast Track Stent study 2): A randomized prospective evaluation.,"OBJECTIVES


To determine whether in pre-stented patients undergoing ureteroscopic stone removal (ureteroscopy retrograde surgery) a tubeless procedure provides a better outcome compared with short-term (6 h) ureteral stenting using an external ureteral catheter.
METHODS


In this single academic center study (Fast Track Stent study 2), carried out between May 2016 and April 2018, 121 patients with renal or ureteral calculi were initially treated with double-J insertion. Before secondary ureteroscopy retrograde surgery, patients were prospectively randomized into two groups: tubeless versus ureteral catheter insertion for 6 h after ureteroscopy retrograde surgery. Exclusion criteria were acute urinary tract infection, solitary kidney or stone diameter >25 mm. Study end-points were stent-related symptoms assessed by a validated questionnaire (ureteral stent symptom questionnaire), administered both before and 4 weeks after surgery. Numerical ureteral stent symptom questionnaire scores were compared using the Mann-Whitney-U-test. The level of significance was defined as P < 0.05.
RESULTS


Ureteroscopy retrograde surgery procedures carried out by 13 surgeons resulted in >90% stone removal in all patients (n = 121), with a mean operation time of 19.9 versus 18.0 min for ureteral catheter versus tubeless, respectively (P = 0.37). Patient groups did not differ significantly in their ureteral stent symptom questionnaire scores (urinary index P = 0.24; pain index P = 0.35). Patients showed a significant preference for tubeless procedure over ureteral catheter reinsertion (Question GQ P < 0.0001). The reintervention rate was 13.3% for the tubeless procedure (n = 8) and 1.6% for the ureteral catheter group (n = 1), respectively (P = 0.034).
CONCLUSIONS


Short-term ureteral catheter and no stent insertion after ureteroscopy retrograde surgery stone extraction in pre-stented patients result in comparable quality of life. However, the reintervention rate is higher for tubeless procedures.",2020,"RESULTS


Ureteroscopy retrograde surgery procedures carried out by 13 surgeons resulted in >90% stone removal in all patients (n = 121), with a mean operation time of 19.9 versus 18.0 min for ureteral catheter versus tubeless, respectively (P = 0.37).","['121 patients with renal or ureteral calculi were initially treated with double-J insertion', 'Exclusion criteria were acute urinary tract infection, solitary kidney or stone diameter >25\xa0mm']","['Transient stent placement versus tubeless procedure after ureteroscopy retrograde surgery stone extraction', 'tubeless versus ureteral catheter insertion for 6\xa0h after ureteroscopy retrograde surgery', 'ureteroscopy retrograde surgery', 'short-term (6\xa0h) ureteral stenting using an external ureteral catheter', 'ureteroscopic stone removal (ureteroscopy retrograde surgery', 'Short-term ureteral catheter and no stent insertion after ureteroscopy retrograde surgery stone extraction']","['mean operation time', 'Numerical ureteral stent symptom questionnaire scores', 'reintervention rate', 'stone removal', 'quality of life', 'tubeless procedure over ureteral catheter reinsertion', 'ureteral stent symptom questionnaire scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0242147', 'cui_str': 'Acute urinary tract infection'}, {'cui': 'C0266294', 'cui_str': 'Renal agenesis, unilateral'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]",121.0,0.0665746,"RESULTS


Ureteroscopy retrograde surgery procedures carried out by 13 surgeons resulted in >90% stone removal in all patients (n = 121), with a mean operation time of 19.9 versus 18.0 min for ureteral catheter versus tubeless, respectively (P = 0.37).","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Reicherz', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Maas', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Wenzel', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dahlkamp', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Jüri', 'Initials': 'J', 'LastName': 'Palisaar', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Bodman', 'Affiliation': 'Uroviva Klinik AG, Bülach, Switzerland.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Noldus', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bach', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14291']
318,32963103,Neural effects of oxytocin and mimicry in frontotemporal dementia: A randomized crossover study.,"OBJECTIVE


To determine whether intranasal oxytocin, alone or in combination with instructed mimicry of facial expressions, would augment neural activity in patients with frontotemporal dementia (FTD) in brain regions associated with empathy, emotion processing, and the simulation network, as indexed by blood oxygen-level dependent (BOLD) signal during fMRI.
METHODS


In a placebo-controlled, randomized crossover design, 28 patients with FTD received 72 IU intranasal oxytocin or placebo and then completed an fMRI facial expression mimicry task.
RESULTS


Oxytocin alone and in combination with instructed mimicry increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
CONCLUSIONS


The findings demonstrate latent capacity to augment neural activity in affected limbic and other frontal and temporal regions during social cognition in patients with FTD, and support the promise and need for further investigation of these interventions as therapeutics in FTD.
CLINICALTRIALSGOV IDENTIFIER


NCT01937013.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that a single dose of 72 IU intranasal oxytocin augments BOLD signal in patients with FTD during viewing of emotional facial expressions.",2020,"RESULTS


Oxytocin alone, and in combination with instructed mimicry, increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
","['patients with FTD', 'frontotemporal dementia', 'patients with FTD in brain regions associated with empathy, emotion processing and the simulation network, as indexed by blood-oxygen-level dependent (BOLD) signal during functional magnetic resonance imaging (fMRI', 'patients with FTD during viewing of emotional facial expressions', '28 patients with FTD received 72 IU of']","['intranasal oxytocin, alone or in combination with instructed mimicry of facial expressions', 'oxytocin', 'placebo', 'Oxytocin', 'intranasal oxytocin or placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal dementia'}, {'cui': 'C0236642', 'cui_str': ""Pick's disease""}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0233577', 'cui_str': 'Mimicry'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],28.0,0.3629,"RESULTS


Oxytocin alone, and in combination with instructed mimicry, increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
","[{'ForeName': 'Lindsay D', 'Initials': 'LD', 'LastName': 'Oliver', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Coleman', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kryklywy', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bartha', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Derek G V', 'Initials': 'DGV', 'LastName': 'Mitchell', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Finger', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada. Elizabeth.Finger@lhsc.on.ca.'}]",Neurology,['10.1212/WNL.0000000000010933']
319,32966603,Video-Enhanced Care Management for Medically Complex Older Adults with Cognitive Impairment.,"OBJECTIVE


This pilot study assessed feasibility of video-enhanced care management for complex older veterans with suspected mild cognitive impairment (CI) and their care partners, compared with telephone delivery.
DESIGN


Pilot randomized controlled trial.
SETTING


Durham Veterans Affairs Health Care System.
PARTICIPANTS


Participants were enrolled as dyads, consisting of veterans aged 65 years or older with complex medical conditions (Care Assessment Need score ≥90) and suspected mild CI (education-adjusted Modified Telephone Interview for Cognitive Status score 20-31) and their care partners.
INTERVENTION


The 12-week care management intervention consisted of monthly calls from a study nurse covering medication management, cardiovascular disease risk reduction, physical activity, and sleep behaviors, delivered via video compared with telephone.
MEASUREMENTS


Dyads completed baseline and follow-up assessments to assess feasibility, acceptability, and usability.
RESULTS


Forty veterans (mean (standard deviation (SD)) age = 72.4 (6.1) years; 100% male; 37.5% Black) and their care partners (mean (SD) age = 64.7 (10.8) years) were enrolled and randomized to telephone or video-enhanced care management. About a third of veteran participants indicated familiarity with relevant technology (regular tablet use and/or experience with videoconferencing); 53.6% of internet users were comfortable or very comfortable using the internet. Overall, 43 (71.7%) care management calls were completed in the video arm and 52 (86.7%) were completed in the telephone arm. Usability of the video telehealth platform was rated higher for participants already familiar with technology used to deliver the intervention (mean (SD) System Usability Scale scores: 65.0 (17.0) vs 55.6 (19.6)). Veterans, care partners, and study nurses reported greater engagement, communication, and interaction in the video arm.
CONCLUSION


Video-delivered care management calls were feasible and preferred over telephone for some complex older adults with mild CI and their care partners. Future research should focus on understanding how to assess and incorporate patient and family preferences related to uptake and maintenance of video telehealth interventions.",2021,Usability of the video telehealth platform was rated higher for participants already familiar with technology used to deliver the intervention (mean (SD) System Usability Scale scores: 65.0 (17.0) vs 55.6 (19.6)).,"['Forty veterans (mean (standard deviation (SD)) age = 72.4 (6.1) years; 100% male; 37.5% Black) and their care partners (mean (SD) age = 64.7 (10.8) years', 'Medically Complex Older Adults with Cognitive Impairment', 'Participants were enrolled as dyads, consisting of veterans aged 65\u2009years or older with complex medical conditions (Care Assessment Need score ≥90) and suspected mild CI (education-adjusted Modified Telephone Interview for Cognitive Status score 20-31) and their care partners', 'complex older adults with mild CI and their care partners', 'complex older veterans with suspected mild cognitive impairment (CI) and their care partners', 'Durham Veterans Affairs Health Care System']","['care management intervention consisted of monthly calls from a study nurse covering medication management, cardiovascular disease risk reduction, physical activity, and sleep behaviors, delivered via video compared with telephone', 'Video-Enhanced Care Management', 'video-enhanced care management', 'telephone or video-enhanced care management', 'Video-delivered care management calls were feasible and preferred over telephone']","['feasibility, acceptability, and usability']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0454851', 'cui_str': 'Durham'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0735304,Usability of the video telehealth platform was rated higher for participants already familiar with technology used to deliver the intervention (mean (SD) System Usability Scale scores: 65.0 (17.0) vs 55.6 (19.6)).,"[{'ForeName': 'Susan N', 'Initials': 'SN', 'LastName': 'Hastings', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Mahanna', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Theodore S Z', 'Initials': 'TSZ', 'LastName': 'Berkowitz', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Smith', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Choate', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Jaime M', 'Initials': 'JM', 'LastName': 'Hughes', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Juliessa', 'Initials': 'J', 'LastName': 'Pavon', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Katina', 'Initials': 'K', 'LastName': 'Robinson', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hendrix', 'Affiliation': 'Center for the Study of Human Aging and Development, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Van Houtven', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Gentry', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Rose', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Plassman', 'Affiliation': 'Center for the Study of Human Aging and Development, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Potter', 'Affiliation': 'Department of Psychiatry, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Oddone', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16819']
320,32967805,Effects of home-based inspiratory muscle training on sickle cell disease (SCD) patients.,"INTRODUCTION


Inspiratory muscle training (IMT) has been shown to be an efficient method of improving exercise tolerance and inspiratory and expiratory muscle strength in several diseases. The effects of IMT on patients with sickle cell anemia (SCD) are relatively unknown. Our study aimed to evaluate the effects of IMT on adult SCD patients, regarding respiratory muscle strength (RMS) variables, lung function, exercise tolerance, blood lactation concentration, limitation imposed by dyspnea during daily activities and impact of fatigue on the quality of life.
METHODS


This was a randomized single-blind study, with an IMT design comprising true load (TG) and sham load (SG) groups. Initial assessment included spirometry, volumetric capnography (VCap) and measurement of RMS by maximal inspiratory and expiratory pressure (PImax and PEmax). The Medical Research Council dyspnea scale and modified fatigue impact scale were also applied and blood lactate concentration was measured before and after the 6-minute walk test. After this initial assessment, the patient used the IMT device at home daily, returning every 6 weeks for RMS reassessment. Both groups used the same device and were unaware of which group they were in. After a period totaling 18 weeks, patients underwent the final evaluation, as initially performed.
RESULTS


Twenty-five patients in total participated until the end of the study (median age 42 years). There were no significant differences between TG and SG based on age, sex, body mass index or severity of genotype. At the end of the training, both groups showed a significant increase in PEmax and PImax, improvement in Vcap and in exercise tolerance and dyspnea reduction while performing daily life activities. The same was observed in patients grouped according to disease severity (HbSS and HbSβ 0 vs HbSC and HbSβ + ), without differences between groups.
CONCLUSION


Home-based inspiratory muscle training benefits outpatients with SCD, including the sham load group.
TRIAL REGISTRATION


http://www.ensaiosclinicos.gov.br; registration number: RBR-6g8n92.",2021,"At the end of the training, both groups showed a significant increase in PEmax and PImax, improvement in Vcap and in exercise tolerance and dyspnea reduction while performing daily life activities.","['Twenty-five patients in total participated until the end of the study (median age 42 years', 'sickle cell disease (SCD) patients', 'patients with sickle cell anemia (SCD', 'adult SCD patients']","['IMT design comprising true load (TG) and sham load (SG', 'IMT', 'home-based inspiratory muscle training', 'Inspiratory muscle training (IMT', 'Home-based inspiratory muscle training']","['respiratory muscle strength (RMS) variables, lung function, exercise tolerance, blood lactation concentration, limitation imposed by dyspnea during daily activities and impact of fatigue on the quality of life', 'Medical Research Council dyspnea scale and modified fatigue impact scale', 'Initial assessment included spirometry, volumetric capnography (VCap) and measurement of RMS by maximal inspiratory and expiratory pressure (PImax and PEmax', 'PEmax and PImax, improvement in Vcap and in exercise tolerance and dyspnea reduction', 'blood lactate concentration']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0376529', 'cui_str': 'Capnography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",,0.0308916,"At the end of the training, both groups showed a significant increase in PEmax and PImax, improvement in Vcap and in exercise tolerance and dyspnea reduction while performing daily life activities.","[{'ForeName': 'Fábio', 'Initials': 'F', 'LastName': 'Galvão', 'Affiliation': 'Universidade Estadual Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Camila Tatiana', 'Initials': 'CT', 'LastName': 'Zanoni', 'Affiliation': 'Universidade Estadual Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Marcos Mello', 'Initials': 'MM', 'LastName': 'Moreira', 'Affiliation': 'Universidade Estadual Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Ilma Aparecida', 'Initials': 'IA', 'LastName': 'Paschoal', 'Affiliation': 'Universidade Estadual Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Sara Teresinha Olalla', 'Initials': 'STO', 'LastName': 'Saad', 'Affiliation': 'Universidade Estadual Campinas (UNICAMP), Campinas, SP, Brazil. Electronic address: sara@unicamp.br.'}]","Hematology, transfusion and cell therapy",['10.1016/j.htct.2020.08.005']
321,32985396,Effects on sleep from group activity with a robotic seal for nursing home residents with dementia: a cluster randomized controlled trial.,"OBJECTIVES


Sleep disturbances are common in people with dementia and increase with the severity of the disease. Sleep disturbances are complex and caused by several factors and are difficult to treat. There is a need for more robust and systematic studies dealing with sleep disturbances in older people with dementia. The aim of this study was to investigate effects from robot-assisted (Paro) group activity on sleep patterns in nursing home (NH) residents with dementia.
DESIGN


A cluster randomized controlled trial.
SETTING


Special care units in 10 NH in Norway.
PARTICIPANTS


A total of 60 participants over 65 years with dementia were recruited. Thirty participants were recruited to the intervention group and 30 participants to the control group.
INTERVENTION


Participants participated in group activity with Paro for 30 minutes twice a week over 12 weeks or in control group (treatment as usual).
MEASUREMENTS


Sleep-wake patterns were assessed objectively by 7 days of wrist actigraphy before and after the intervention. Data were collected between March 2013 and September 2014. Data were analyzed using mixed models.
RESULTS


Positive effects on change in sleep were found in the intervention group as compared with the control group. The intervention group increased percentage of sleep efficiency, increased the amount of total sleep time and reduced number of nocturnal awakenings. In addition, a significant effect was found in reduced awakenings after sleep onset.
CONCLUSIONS


Social stimulation through engaging group activity could contribute to improved sleep in people with dementia in NH. Increased sleep efficiency and total sleep time, in addition to fewer night awakenings, affect central indicators of good sleep quality across the life span. Improved sleep quality will also affect quality of life and comorbidities in vulnerable groups. We believe group activity with Paro to be an accessible and feasible non-pharmacological treatment for those who enjoy Paro.",2021,"The intervention group increased percentage of sleep efficiency, increased the amount of total sleep time and reduced number of nocturnal awakenings.","['Special care units in 10 NH in Norway', 'Thirty participants were recruited to the intervention group and 30 participants to the control group', 'people with dementia in NH', '60 participants over 65 years with dementia were recruited', 'nursing home (NH) residents with dementia', 'nursing home residents with dementia', 'older people with dementia']","['robot-assisted (Paro) group activity', 'robotic seal']","['reduced awakenings after sleep onset', 'change in sleep', 'Sleep-wake patterns', 'amount of total sleep time and reduced number of nocturnal awakenings', 'quality of life and comorbidities', 'sleep efficiency and total sleep time', 'night awakenings, affect central indicators of good sleep quality', 'sleep quality', 'percentage of sleep efficiency', 'sleep patterns']","[{'cui': 'C0558600', 'cui_str': 'Special care unit'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0036492', 'cui_str': 'Seal'}]","[{'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0860510', 'cui_str': 'Nocturnal awakening'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}]",30.0,0.0624316,"The intervention group increased percentage of sleep efficiency, increased the amount of total sleep time and reduced number of nocturnal awakenings.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Jøranson', 'Affiliation': 'VID Specialized University, Faculty of Health Studies, Campus Diakonhjemmet, P.O. Box 184 Vinderen, N-0319Oslo, Norway.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Olsen', 'Affiliation': 'Norwegian Center of Anthrozoology, Ås, Norway.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Calogiuri', 'Affiliation': 'Inland Norway University of Applied Sciences, Faculty of Social and Health Sciences, Department of Public Health and Sport Sciences, Elverum, Norway.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Ihlebæk', 'Affiliation': 'Norwegian University of Life Sciences, LANDSAM, Department of Public Health Science, Ås, Norway.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Pedersen', 'Affiliation': 'Norwegian University of Life Sciences, LANDSAM, Department of Public Health Science, Ås, Norway.'}]",International psychogeriatrics,['10.1017/S1041610220001787']
322,32964140,A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial.,"Digital health applications (apps) have the potential to improve health behaviors and outcomes. We aimed to examine the effectiveness of a consumer web-based app linked to primary care electronic health records (EHRs). CONNECT was a multicenter randomized controlled trial involving patients with or at risk of cardiovascular disease (CVD) recruited from primary care (Clinical Trial registration ACTRN12613000715774). Intervention participants received an interactive app which was pre-populated and refreshed with EHR risk factor data, diagnoses and, medications. Interactive risk calculators, motivational messages and lifestyle goal tracking were also included. Control group received usual health care. Primary outcome was adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications). Secondary outcomes included attainment of risk factor targets and eHealth literacy. In total, 934 patients were recruited; mean age 67.6 (±8.1) years. At 12 months, the proportion with >80% days covered with recommended medicines was low overall and there was no difference between the groups (32.8% vs. 29.9%; relative risk [RR] 1.07 [95% CI, 0.88-1.20]  p  = 0.49). There was borderline improvement in the proportion meeting BP and LDL targets in intervention vs. control (17.1% vs. 12.1% RR 1.40 [95% CI, 0.97-2.03]  p  = 0.07). The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control,  p  = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control,  p  = 0.02). In conclusion, a consumer app integrated with primary health care EHRs was not effective in increasing medication adherence. Borderline improvements in risk factors and modest behavior changes were observed.",2020,"The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control,  p  = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control,  p  = 0.02).","['934 patients were recruited; mean age 67.6 (±8.1) years', 'patients with or at risk of cardiovascular disease (CVD) recruited from primary care (Clinical Trial registration ACTRN12613000715774']","['interactive app which was pre-populated and refreshed with EHR risk factor data, diagnoses and, medications', 'consumer web-based app linked to primary care electronic health records (EHRs', 'usual health care', 'digital health intervention']","['risk factors and modest behavior changes', 'proportion meeting BP and LDL targets', 'attainment of risk factor targets and eHealth literacy', 'e-health literacy scores', 'adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications', 'attainment of physical activity targets', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",934.0,0.128827,"The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control,  p  = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control,  p  = 0.02).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Westmead Applied Research Centre, Sydney, NSW Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Coorey', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mulley', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Scaria', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Neubeck', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, Scotland.'}, {'ForeName': 'Nashid', 'Initials': 'N', 'LastName': 'Hafiz', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Westmead Applied Research Centre, Sydney, NSW Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Pitt', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Weir', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Forbes', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, Scotland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Bampi', 'Affiliation': 'Fiona Bampi - Cancer Australia, Australian Government, Sydney, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Coenen', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Enright', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Westmead Applied Research Centre, Sydney, NSW Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Centre for Transplant and Renal Research, Westmead Institute for Medical Research, The University of Sydney, Westmead, NSW Australia.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': 'Centre for Primary Health Care and Equity, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Zwar', 'Affiliation': 'Faculty of Health Sciences & Medicine, Bond University, Gold Coast, QLD Australia.'}, {'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Westmead Applied Research Centre, Sydney, NSW Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Heeley', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Panaretto', 'Affiliation': 'Centre for Chronic Disease, The University of Queensland, Brisbane, QLD Australia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lau', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, Sydney, NSW Australia.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Hayman', 'Affiliation': 'Queensland Health, Brisbane, QLD Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Usherwood', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Westmead Applied Research Centre, Sydney, NSW Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peiris', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}]",NPJ digital medicine,['10.1038/s41746-020-00325-z']
323,32974974,The impact of occlusive vs non-occlusive application of 5-aminolevulinic acid (BF-200 ALA) on the efficacy and tolerability of photodynamic therapy for actinic keratosis on the scalp and face: A prospective within-patient comparison trial.,"BACKGROUND


Photodynamic therapy (PDT) is an effective treatment for actinic keratoses (AK). PDT is usually performed with occlusion of the photosensitizer prior to subsequent illumination.
OBJECTIVES


This study aimed to compare the efficacy and tolerability of occlusive versus non-occlusive application of a 5-aminolevulinic gel (BT-200 ALA) for PDT of multiple AK on the scalp or face.
METHODS


Prospective, investigator-blinded, within-patient comparison study on 45 patients. PDT with occlusion of ALA was performed in a target area on one randomized side of the scalp or face. One week later a contralateral target area received the same treatment except that no occlusion of the ALA gel was performed. 3 and 6 months after PDT, the clearance rate of a predetermined target lesion and the total clearance rate of all AK within the treated areas were determined. PDT-induced pain and skin phototoxicity and cosmetic outcome were also recorded.
RESULTS


Clearance rate of the target AK and total AK clearance rate at 3 months after PDT was 88.4% and 90.6% for occlusive PDT and 58.1% (P = .001) and 70.4% (P = .04) for non-occlusive PDT. The corresponding values at 6 months after PDT were 69.7% and 72.1% for occlusive PDT and 30.2% (P < .001) and 35.6% (P = .001) for non-occlusive PDT. Pain score and skin phototoxicity were significantly higher after occlusive ALA application. No difference was observed with respect to cosmetic outcome.
CONCLUSIONS


Occlusive application of ALA significantly improves the efficacy of PDT but is associated with more pain and increased phototoxicity.",2021,"No difference was observed with respect to cosmetic outcome.
","['actinic keratoses (AK', 'actinic keratosis on the scalp and face', '45 patients']","['PDT with occlusion of ALA', 'Photodynamic therapy (PDT', '5-aminolaevulinic gel (BT-200 ALA', 'photodynamic therapy', '5-aminolaevulinic acid (BF-200 ALA']","['pain and increased phototoxicity', 'clearance rate of a predetermined target lesion and the total clearance rate', 'Pain score and skin phototoxicity', 'PDT-induced pain and skin phototoxicity and cosmetic outcome', 'efficacy and tolerability', 'cosmetic outcome', 'Clearance rate of the target AK and total AK clearance rate']","[{'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C3490787', 'cui_str': 'BF-200 ALA'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162830', 'cui_str': 'Phototoxic dermatitis'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}]",45.0,0.0397044,"No difference was observed with respect to cosmetic outcome.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Meierhofer', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Silic', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Urban', 'Affiliation': 'Trauma Hospital Klagenfurt, Klagenfurt am Wörthersee, Austria.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Tanew', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Radakovic', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12613']
324,32989636,Cognitive Behavioral Therapy-Based Short-Term Abstinence Intervention for Problematic Social Media Use: Improved Well-Being and Underlying Mechanisms.,"Problematic social media use is detrimental to users' subjective well-being. Based on cognitive behavioral therapy (CBT), we proposed a short-term abstinence intervention to treat this problem. A mixed method study with 65 participants was conducted to examine the effectiveness of this intervention and to reveal the underlying mechanisms of how the intervention influences participants. While the experimental group (N = 33) took eight 2.5-h breaks from social media over two weeks and had daily dairies, the control group (N = 32) used social media as usual and had daily diaries. The results demonstrated that the intervention has a positive effect on life satisfaction. The effect varied with the time users conducted abstinence (work hours vs. off hours) and the level of social media addiction (heavy users vs. normal users). Qualitative findings from dairies and interviews unveiled associations among users' behaviors, feelings, and cognitions during and after abstinence. These results extend the understanding of the CBT-based short-term abstinence intervention and suggest opportunities to alleviate problematic social media use.",2021,These results extend the understanding of the CBT-based short-term abstinence intervention and suggest opportunities to alleviate problematic social media use.,"['Problematic Social Media Use', '65 participants']","['cognitive behavioral therapy (CBT', 'Cognitive Behavioral Therapy-Based Short-Term Abstinence Intervention']","['level of social media addiction', 'life satisfaction']","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",65.0,0.0206778,These results extend the understanding of the CBT-based short-term abstinence intervention and suggest opportunities to alleviate problematic social media use.,"[{'ForeName': 'Xingchen', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Industrial Engineering, Tsinghua University, Beijing, China.'}, {'ForeName': 'Pei-Luen Patrick', 'Initials': 'PP', 'LastName': 'Rau', 'Affiliation': 'Department of Industrial Engineering, Tsinghua University, Beijing, China. rpl@tsinghua.edu.cn.'}, {'ForeName': 'Chi-Lan', 'Initials': 'CL', 'LastName': 'Yang', 'Affiliation': 'Cyber Interface Lab, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Industrial Engineering, Tsinghua University, Beijing, China.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09852-0']
325,32965037,Melatonin for Acute Treatment of Migraine in Children and Adolescents: A Pilot Randomized Trial.,"OBJECTIVE


To determine what dose of melatonin is most effective for treating migraine acutely in children and adolescents.
BACKGROUND


Acute migraine medications may not work for all patients and may cause side effects. Melatonin is effective for migraine prevention in adults and has been used acutely for procedural pain in children. Our goal was to determine whether a ""high"" or ""low"" dose of melatonin is more effective for treating migraine acutely in youth.
METHODS


In this pilot, randomized, open-label, single-center, dose-finding trial, children and adolescents aged 4-17 years with episodic migraine were randomized to ""high-dose"" or ""low-dose"" dose melatonin (<40 kg: 4 mg vs. 1 mg; ≥40 kg: 8 mg vs. 2 mg). The primary outcome measure was change in mean pain score between time 0 and 2 hours. Secondary outcomes included 2-hour pain-relief and pain-freedom rates.
RESULTS


Eighty-four participants (n = 42 per group) were enrolled in this study. Mean (SD) participant age was 11.8 (3.5) years and 55% (46/84) were female. Mean (SD) headache days/month was 5.6 (3.8). Sixty-six (79%) participants provided outcome data and were included in the analyses, n = 24 in the high-dose group and n = 22 in the low-dose group. The drop-out rate was 43% (18/42) in the high-dose group vs. 48% (20/42) in the low-dose group. Mean (SD) change in pain intensity at 2 hours was -2.7 (2.1) cm in the high-dose group vs. -2.3 (2.1) cm in the low-dose group (p = .581), a difference of 0.4 cm (95% CI: -1.17 to 1.92). Two-hour pain-freedom rate was 41% (7/17) vs. 27% (4/15) in the high-dose vs. low-dose groups (p = .415), and 2-hour pain-relief rate was 94% (16/17) vs. 80% (12/15), (p = .482). There were no serious adverse events. Napping occurred in the majority (67% (14/21) high dose vs. 47% (9/19) low dose). Higher mg/kg dose of melatonin and napping were each independently associated with greater headache benefit.
CONCLUSIONS


As an acute treatment for pediatric migraine, both low and high doses of melatonin were associated with pain reduction; however, study drop-out was high. Higher dose and napping after treatment predicted greater benefit.",2020,The drop-out rate was 43% (18/42) in the high-dose group vs. 48% (20/42) in the low-dose group.,"['n\xa0=\xa042 per group) were enrolled in this study', 'Eighty-four participants ', 'children and adolescents', 'Sixty-six (79%) participants provided outcome data and were included in the analyses, n\xa0', 'Children and Adolescents', 'children and adolescents aged 4-17\xa0years with episodic migraine', 'Mean (SD) participant age was 11.8 (3.5) years and 55% (46/84) were female']","['melatonin', 'high-dose"" or ""low-dose"" dose melatonin', 'Melatonin']","['mean pain score', 'Mean (SD) change in pain intensity', 'headache benefit', 'Mean (SD) headache days/month', '2-hour pain-relief and pain-freedom rates', '2-hour pain-relief rate', 'pain-freedom rate', 'serious adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.322068,The drop-out rate was 43% (18/42) in the high-dose group vs. 48% (20/42) in the low-dose group.,"[{'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gelfand', 'Affiliation': 'Department of Neurology, UCSF Child & Adolescent Headache Program, San Francisco, CA, USA.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Ross', 'Affiliation': 'Department of Pediatrics, UCSF Child & Adolescent Headache Program, San Francisco, CA, USA.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Irwin', 'Affiliation': 'Department of Neurology, UCSF Child & Adolescent Headache Program, San Francisco, CA, USA.'}, {'ForeName': 'Kaitlin A', 'Initials': 'KA', 'LastName': 'Greene', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Qubty', 'Affiliation': 'Pediatric Headache Program, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'I Elaine', 'Initials': 'IE', 'LastName': 'Allen', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, CA, USA.'}]",Headache,['10.1111/head.13934']
326,32981043,"A Randomized, Double-Dummy, Emergency Department-Based Study of Greater Occipital Nerve Block With Bupivacaine vs Intravenous Metoclopramide for Treatment of Migraine.","BACKGROUND


Greater occipital nerve blocks (GONB) are used increasingly to treat acute migraine.
OBJECTIVE


We conducted a randomized controlled trial to determine whether GONB was as effective as intravenous metoclopramide for migraine.
METHODS


This was a double-dummy, double-blind, parallel-arm, non-inferiority study conducted in 2 emergency departments (EDs). Patients with migraine of moderate or severe intensity were randomized to receive bilateral GONB with each side administered 3 mL of bupivacaine 0.5% or metoclopramide 10 mg IV, the putative standard of care. The primary outcome was improvement in pain on a 0-10 scale between time 0 and 1 hour later. To reject the null hypothesis that metoclopramide would be more efficacious in relieving pain, we required that the lower limit of the 95% CI for the difference in pain improvement between those randomized to GONB vs those randomized to metoclopramide be >-1.3, a validated minimum clinically important difference. Secondary outcomes included sustained headache relief, defined as achieving and maintaining for 48 hours a headache level of mild or none without the use of additional analgesic medication, and the use of rescue medication in the ED.
RESULTS


Over a 2.5-year study period, 1358 patients were screened for participation and 99 were randomized, 51 to GONB and 48 to metoclopramide. All of these patients were included in the primary analysis. Patients who received the GONB reported mean improvement of 5.0 (95% CI: 4.1, 5.8) while those who received metoclopramide reported a larger mean improvement of 6.1 (95% CI: 5.2, 6.9). The 95% CI for the between group difference of -1.1 was -2.3, 0.1. Sustained headache relief was reported by 11/51 (22%) GONB and 18/47 (38%) metoclopramide patients (95% CI for rounded difference of 17%: -1, 35%). Of the 51 GONB patients, 17 (33%) required rescue medication in the ED vs 8/48 (17%) metoclopramide patients (95% CI for rounded difference of 17%: 0, 33%). An adverse event was reported by 16/51 (31%) GONB patients and 18/48 (38%) metoclopramide patients (95% CI for (rounded) difference of 6%: -13, 25%).
CONCLUSION


GONB with bupivacaine was not as efficacious as IV metoclopramide for the first-line treatment of migraine in the ED.",2020,"The 95% CI for the between group difference of -1.1 was -2.3, 0.1.","['Patients with migraine of moderate or severe intensity', '1358 patients were screened for participation and 99 were randomized, 51 to GONB and 48 to', '2 emergency departments (EDs']","['bupivacaine', 'GONB', 'Bupivacaine vs Intravenous Metoclopramide', 'metoclopramide', 'bilateral GONB with each side administered 3\xa0mL of bupivacaine 0.5% or metoclopramide']","['rescue medication', 'pain on a 0-10 scale between time 0 and 1\xa0hour later', 'sustained headache relief, defined as achieving and maintaining for 48\xa0hours a headache level of mild or none without the use of additional analgesic medication, and the use of rescue medication in the ED', 'adverse event', 'relieving pain', 'Sustained headache relief', 'pain improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0394692', 'cui_str': 'Injection of anesthetic agent into greater occipital nerve'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0394692', 'cui_str': 'Injection of anesthetic agent into greater occipital nerve'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",1358.0,0.637252,"The 95% CI for the between group difference of -1.1 was -2.3, 0.1.","[{'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Friedman', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Irizarry', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Clemencia', 'Initials': 'C', 'LastName': 'Solorzano', 'Affiliation': 'Pharmacy Department, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Zias', 'Affiliation': 'Pharmacy Department, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Robbins', 'Affiliation': 'Department of Neurology, Weill Cornell Medicine, New York-Presbyterian, New York, NY, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Harrilal', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Del Valle', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Polly E', 'Initials': 'PE', 'LastName': 'Bijur', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Gallagher', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}]",Headache,['10.1111/head.13961']
327,32973117,Sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer: a multi-center randomized trial (PHENIX/CSEM 010).,"BACKGROUND


There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer. It is unclear whether and when pelvic lymphadenectomy can be safely replaced by SLN biopsy alone.
PRIMARY OBJECTIVE


To comprehensively compare the oncological outcomes of SLN biopsy with pelvic lymphadenectomy in patients with and without SLN metastasis.
STUDY HYPOTHESIS


It is hypothesized that the oncological outcomes provided by SLN biopsy are non-inferior to those of pelvic lymphadenectomy in patients with clinically early-stage cervical cancer if risk-adapted adjuvant treatments are given.
TRIAL DESIGN


All eligible patients will undergo SLN biopsy at the start of surgery. The resected SLNs will be submitted for frozen section examination. and patients will be triaged into the PHENIX-I (SLN-negative) or PHENIX-II (SLN-positive) cohort. In each cohort of this trial, patients will be randomized in a 1:1 ratio into the experimental (SLN biopsy alone) or reference (pelvic lymphadenectomy) arm. Radical hysterectomy will be performed for all patients, and adjuvant treatments will be planned according to post-operative pathological factors.
MAJOR INCLUSION/EXCLUSION CRITERIA


Patients aged between 18 and 65 years with histologically confirmed, untreated stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma.
PRIMARY ENDPOINT


The primary endpoint is disease-free survival.
SAMPLE SIZE


Estimated sample sizes of 830 and 250 are required to fulfill the study objectives of PHENIX-I and II, respectively.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


As of May 2020, more than 600 eligible patients have been enrolled. Enrollment is expected to be completed by December 2022, and presentation of results is expected in 2026.
TRIAL REGISTRATION


NCT02642471.",2020,"BACKGROUND


There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer.","['early-stage cervical cancer', 'patients with clinically early-stage cervical cancer', 'All eligible patients will undergo SLN biopsy at the start of surgery', '600 eligible patients have been enrolled', 'patients with and without SLN metastasis', 'Patients aged between 18 and 65 years with histologically confirmed, untreated stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma']","['pelvic lymphadenectomy', 'Radical hysterectomy', 'Sentinel lymph node biopsy versus pelvic lymphadenectomy', 'experimental (SLN biopsy alone) or reference (pelvic lymphadenectomy', 'SLN biopsy with pelvic lymphadenectomy']",['disease-free survival'],"[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous carcinoma'}]","[{'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.17339,"BACKGROUND


There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Tu', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Bingna', 'Initials': 'B', 'LastName': 'Xian', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Clinical Trial Center, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Gynecologic Oncology, Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""Department of Gynecologic Oncology, Women's Hospital of Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecologic Oncology, Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Beihua', 'Initials': 'B', 'LastName': 'Kong', 'Affiliation': 'Department of Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Gynecology, Guangdong Province Traditional Chinese Medical Hospital, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China liujih@mail.sysu.edu.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001857']
328,32964915,Care Starts at Home: Emotional State and Appeals to Altruism may Reduce Demand for Overused Health Services in the UK.,"BACKGROUND


Overuse of unnecessary services, screening tests, and treatments is an ongoing problem for national health care systems. Overuse is at least partly driven by patient demand.
PURPOSE


This study examined whether altering patients' emotional state and appealing to patient altruism would reduce demand for three commonly overused UK health services.
METHODS


In an online experiment, 1,267 UK volunteers were randomized to anxiety, compassion, or neutral conditions before viewing three overuse vignettes. In each vignette, use of the health service was recommended against by the doctor and participants were further randomized to one of three altruism frames, emphasizing the impact of overuse on the self, the self and others locally, or the self and others nationally. Participants rated the likelihood that they would pursue the health service and, assuming that they did not, how long they would be willing-to-wait for it.
RESULTS


Altruism frame had a small effect on intentions to use the health service. Those in the local or national (vs. self) frame were 4.7 and 6.1 percentage points, respectively, less likely to ask for the service. Emotion induction had no direct effect on outcomes. However, self-reporting higher levels of anxiety or compassion post-induction was associated with a small, greater likelihood in intentions to ask for the health service or willingness-to-wait, respectively. No interactions between frame and emotion were observed.
CONCLUSIONS


As a low-cost initiative, emphasizing the benefits to the self and local or national communities could be embedded in appeals designed to appropriately reduce health care overuse in the UK.",2021,Emotion induction had no direct effect on outcomes.,"['1,267 UK volunteers were randomized to anxiety, compassion, or neutral conditions before viewing three overuse vignettes']",[],['small effect on intentions to use the health service'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0449911', 'cui_str': 'View'}]",[],"[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",1267.0,0.0479352,Emotion induction had no direct effect on outcomes.,"[{'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Powell', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Economics, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gabbay', 'Affiliation': 'Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Nathan S', 'Initials': 'NS', 'LastName': 'Consedine', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa058']
329,33236687,"Intracranial aneurysms managed by parent artery reconstruction using Tubridge: Study protocol for a prospective, multicenter, post-market clinical trial.","BACKGROUND


As a new endovascular reconstruction technique, flow diverter (FD) shows excellent efficacy and safety for treatment of intracranial aneurysms. In a previous multicenter, randomized, controlled, pre-market study, Tubridge FD showed remarkably higher complete occlusion rate compared with traditional stent-assisted coiling. However, a nonsignificant higher complication rate in the Tubridge group was noted. Considering the learning curve, the safety, and long-term outcomes of Tubridge FD should be verified in new prospective, real world, multicenter, post-market trials.
METHODS


This study is a prospective, multicenter, single-arm, post-market clinical trial that evaluates the safety and efficacy of Tubridge in the treatment of patients with intracranial aneurysms by reconstructing parent artery. We expect 200 participants who meet the inclusion and exclusion criteria to be included. Clinical information and angiographic results (Raymond-Roy grading scale, RRGS) will be recorded objectively. The primary endpoint will be the complete occlusion rate of the target aneurysm (RRGS 1) at 12-month follow-up. Secondary endpoints will include the adequate occlusion rate (RRGS 1 & 2) and the rate of major in-stent stenosis (>50%) at 12-month follow-up, technique success rate, changes of modified Rankin Scale before and after the procedure, the rate of aneurysm related disability, neurological mortality, and all-cause mortality within follow-up period.
DISCUSSION


This post-market, prospective trial may offer more information on the safety and long-term outcomes of Tubridge FD. When the study is complete, the results may provide us a new strategy for the treatment of intracranial aneurysms. Trial registration:  WHO-Chinese Clinical Trial Registry: ChiCTR2000032282.",2021,The primary endpoint will be the complete occlusion rate of the target aneurysm (RRGS 1) at 12-month follow-up.,"['200 participants who meet the inclusion and exclusion criteria to be included', 'patients with intracranial aneurysms by reconstructing parent artery']","['Tubridge', 'endovascular reconstruction technique, flow diverter (FD', 'traditional stent-assisted coiling']","['complete occlusion rate', 'complication rate', 'complete occlusion rate of the target aneurysm (RRGS 1', 'adequate occlusion rate (RRGS 1 & 2) and the rate of major in-stent stenosis', 'technique success rate, changes of modified Rankin Scale', 'rate of aneurysm related disability, neurological mortality, and all-cause mortality']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]","[{'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4049553', 'cui_str': 'Stent stenosis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",200.0,0.0971115,The primary endpoint will be the complete occlusion rate of the target aneurysm (RRGS 1) at 12-month follow-up.,"[{'ForeName': 'Qiaowei', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Department of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, China.""}, {'ForeName': 'Qiuji', 'Initials': 'Q', 'LastName': 'Shao', 'Affiliation': ""Department of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, China.""}, {'ForeName': 'Tianming', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': ""Department of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, China.""}, {'ForeName': 'Kaitao', 'Initials': 'K', 'LastName': 'Chang', 'Affiliation': ""Department of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, China.""}, {'ForeName': 'Tianxiao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Department of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, China.""}, {'ForeName': 'Yingkun', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, China.""}]","Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences",['10.1177/1591019920976233']
330,33002437,"Adjuvant radiotherapy versus early salvage radiotherapy following radical prostatectomy (TROG 08.03/ANZUP RAVES): a randomised, controlled, phase 3, non-inferiority trial.","BACKGROUND


Adjuvant radiotherapy has been shown to halve the risk of biochemical progression for patients with high-risk disease after radical prostatectomy. Early salvage radiotherapy could result in similar biochemical control with lower treatment toxicity. We aimed to compare biochemical progression between patients given adjuvant radiotherapy and those given salvage radiotherapy.
METHODS


We did a phase 3, randomised, controlled, non-inferiority trial across 32 oncology centres in Australia and New Zealand. Eligible patients were aged at least 18 years and had undergone a radical prostatectomy for adenocarcinoma of the prostate with pathological staging showing high-risk features defined as positive surgical margins, extraprostatic extension, or seminal vesicle invasion; had an Eastern Cooperative Oncology Group performance status of 0-1, and had a postoperative prostate-specific antigen (PSA) concentration of 0·10 ng/mL or less. Patients were randomly assigned (1:1) using a minimisation technique via an internet-based, independently generated allocation to either adjuvant radiotherapy within 6 months of radical prostatectomy or early salvage radiotherapy triggered by a PSA of 0·20 ng/mL or more. Allocation sequence was concealed from investigators and patients, but treatment assignment for individual randomisations was not masked. Patients were stratified by radiotherapy centre, preoperative PSA, Gleason score, surgical margin status, and seminal vesicle invasion status. Radiotherapy in both groups was 64 Gy in 32 fractions to the prostate bed without androgen deprivation therapy with real-time review of plan quality on all cases before treatment. The primary endpoint was freedom from biochemical progression. Salvage radiotherapy would be deemed non-inferior to adjuvant radiotherapy if freedom from biochemical progression at 5 years was within 10% of that for adjuvant radiotherapy with a hazard ratio (HR) for salvage radiotherapy versus adjuvant radiotherapy of 1·48. The primary analysis was done on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, NCT00860652.
FINDINGS


Between March 27, 2009, and Dec 31, 2015, 333 patients were randomly assigned (166 to adjuvant radiotherapy; 167 to salvage radiotherapy). Median follow-up was 6·1 years (IQR 4·3-7·5). An independent data monitoring committee recommended premature closure of enrolment because of unexpectedly low event rates. 84 (50%) patients in the salvage radiotherapy group had radiotherapy triggered by a PSA of 0·20 ng/mL or more. 5-year freedom from biochemical progression was 86% (95% CI 81-92) in the adjuvant radiotherapy group versus 87% (82-93) in the salvage radiotherapy group (stratified HR 1·12, 95% CI 0·65-1·90; p non-inferiority =0·15). The grade 2 or worse genitourinary toxicity rate was lower in the salvage radiotherapy group (90 [54%] of 167) than in the adjuvant radiotherapy group (116 [70%] of 166). The grade 2 or worse gastrointestinal toxicity rate was similar between the salvage radiotherapy group (16 [10%]) and the adjuvant radiotherapy group (24 [14%]).
INTERPRETATION


Salvage radiotherapy did not meet trial specified criteria for non-inferiority. However, these data support the use of salvage radiotherapy as it results in similar biochemical control to adjuvant radiotherapy, spares around half of men from pelvic radiation, and is associated with significantly lower genitourinary toxicity.
FUNDING


New Zealand Health Research Council, Australian National Health Medical Research Council, Cancer Council Victoria, Cancer Council NSW, Auckland Hospital Charitable Trust, Trans-Tasman Radiation Oncology Group Seed Funding, Cancer Research Trust New Zealand, Royal Australian and New Zealand College of Radiologists, Cancer Institute NSW, Prostate Cancer Foundation Australia, and Cancer Australia.",2020,Salvage radiotherapy would be deemed non-inferior to adjuvant radiotherapy if freedom from biochemical progression at 5 years was within 10% of that for adjuvant radiotherapy with a hazard ratio (HR) for salvage radiotherapy versus adjuvant radiotherapy of 1·48.,"['32 oncology centres in Australia and New Zealand', 'patients with high-risk disease after radical prostatectomy', 'patients given', 'Between March 27, 2009, and Dec 31, 2015, 333 patients were randomly assigned (166 to', 'Eligible patients were aged at least 18 years and had undergone a radical prostatectomy for adenocarcinoma of the prostate with pathological staging showing high-risk features defined as positive surgical margins, extraprostatic extension, or seminal vesicle invasion; had an Eastern Cooperative Oncology Group performance status of 0-1, and had a postoperative prostate-specific antigen (PSA) concentration of 0·10 ng/mL or less']","['Adjuvant radiotherapy versus early salvage radiotherapy', 'Salvage radiotherapy', 'adjuvant radiotherapy', 'minimisation technique via an internet-based, independently generated allocation to either adjuvant radiotherapy within 6 months of radical prostatectomy or early salvage radiotherapy triggered by a PSA of 0·20 ng/mL or more', 'adjuvant radiotherapy; 167 to salvage radiotherapy', 'adjuvant radiotherapy and those given salvage radiotherapy', 'Radiotherapy', 'radical prostatectomy (TROG 08.03/ANZUP RAVES', 'salvage radiotherapy', 'radiotherapy']","['grade 2 or worse gastrointestinal toxicity rate', 'freedom from biochemical progression', 'grade 2 or worse genitourinary toxicity rate']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0443276', 'cui_str': 'Pathological staging'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0036628', 'cui_str': 'Seminal vesicle structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",333.0,0.349874,Salvage radiotherapy would be deemed non-inferior to adjuvant radiotherapy if freedom from biochemical progression at 5 years was within 10% of that for adjuvant radiotherapy with a hazard ratio (HR) for salvage radiotherapy versus adjuvant radiotherapy of 1·48.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kneebone', 'Affiliation': 'Department of Radiation Oncology, Royal North Shore Hospital, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia. Electronic address: andrew.kneebone@health.nsw.gov.au.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Fraser-Browne', 'Affiliation': 'Auckland Hospital, Auckland, New Zealand.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Duchesne', 'Affiliation': 'University of Melbourne, Melbourne, VIC, Australia; Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fisher', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Frydenberg', 'Affiliation': 'Monash University, Melbourne, VIC, Australia; Cabrini Medical Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Williams', 'Affiliation': 'University of Melbourne, Melbourne, VIC, Australia; Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Warick', 'Initials': 'W', 'LastName': 'Delprado', 'Affiliation': 'Douglass Hanly Moir Pathology, Sydney, NSW, Australia; University of Notre Dame Australia, Sydney, NSW, Australia; Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'University of Western Australia, Perth, WA, Australia; Edith Cowan University, Perth, WA, Australia; Genesis Cancer Care, Perth, WA, Australia; 5D Clinics, Perth, WA, Australia.'}, {'ForeName': 'Jarad M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'Calvary Mater Newcastle Hospital, Newcastle, NSW, Australia; School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'John H L', 'Initials': 'JHL', 'LastName': 'Matthews', 'Affiliation': 'Auckland Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Millar', 'Affiliation': 'Monash University, Melbourne, VIC, Australia; Alfred Health Radiation Oncology, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sidhom', 'Affiliation': 'Cancer Therapy Centre, Liverpool Hospital, Sydney, NSW, Australia; University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Spry', 'Affiliation': 'Edith Cowan University, Perth, WA, Australia; Sir Charles Gairdner Hospital, Perth, WA, Australia; Genesis Cancer Care, Perth, WA, Australia.'}, {'ForeName': 'Colin I', 'Initials': 'CI', 'LastName': 'Tang', 'Affiliation': 'Edith Cowan University, Perth, WA, Australia; Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Crown Princess Mary Cancer Centre, Westmead, NSW, Australia.'}, {'ForeName': 'Kirsty L', 'Initials': 'KL', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Henry H', 'Initials': 'HH', 'LastName': 'Woo', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Urology, Sydney Adventist Hospital, Wahroonga, NSW Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Monash University, Melbourne, VIC, Australia; ANZUP Cancer Trials Group, Sydney, NSW, Australia; Eastern Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Tee S', 'Initials': 'TS', 'LastName': 'Lim', 'Affiliation': 'Genesis Cancer Care, Perth, WA, Australia; Curtin Medical School, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pearse', 'Affiliation': 'Auckland Hospital, Auckland, New Zealand.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30456-3']
331,33002888,Can a Lifestyle Genomics Intervention Motivate Patients to Engage in Greater Physical Activity than a Population-Based Intervention? Results from the NOW Randomized Controlled Trial.,"BACKGROUND


Lifestyle genomics (LGx) is a science that explores interactions between genetic variation, lifestyle components such as physical activity (PA), and subsequent health- and performance-related outcomes. The objective of this study was to determine whether an LGx intervention could motivate enhanced engagement in PA to a greater extent than a population-based intervention.
METHODS


In this pragmatic randomized controlled trial, participants received either the standard, population-based Group Lifestyle BalanceTM (GLB) program intervention or the GLB program in addition to the provision of LGx information and advice (GLB + LGx). Participants (n = 140) completed a 7-day PA recall at baseline, 3, 6, and 12 months. Data from the PA recalls were used to calculate metabolic equivalents (METs), a measure of energy expenditure. Statistical analyses included split plot analyses of covariance and binary logistic regression (generalized linear models). Differences in leisure time PA weekly METs, weekly minutes of moderate + high-intensity PA, and adherence to PA guidelines were compared between groups (GLB and GLB + LGx) across the 4 time points.
RESULTS


Weekly METs were significantly higher in the GLB + LGx group (1,114.7 ± 141.9; 95% CI 831.5-1,397.8) compared to the standard GLB group (621.6 ± 141.9 MET/week; 95% CI 338.4-904.8) at the 6-month follow-up (p = 0.01). All other results were non-significant.
CONCLUSIONS


The provision of an LGx intervention resulted in a greater weekly leisure time PA energy expenditure after the 6-month follow-up. Future research should determine how this could be sustained over the long-term.
CLINICAL TRIAL REGISTRATION


NCT03015012.",2020,The provision of an LGx intervention resulted in a greater weekly leisure time PA energy expenditure after the 6-month follow-up.,[],"['GLB + LGx', 'standard, population-based Group Lifestyle BalanceTM (GLB) program intervention or the GLB program in addition to the provision of LGx information and advice (GLB + LGx', 'LGx intervention']","['leisure time PA weekly METs, weekly minutes of moderate + high-intensity PA, and adherence to PA guidelines', 'weekly leisure time PA energy expenditure', '7-day PA recall']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",140.0,0.105505,The provision of an LGx intervention resulted in a greater weekly leisure time PA energy expenditure after the 6-month follow-up.,"[{'ForeName': 'Justine R', 'Initials': 'JR', 'LastName': 'Horne', 'Affiliation': 'Health and Rehabilitation Sciences, The University of Western Ontario, London, Ontario, Canada, jhorne5@uwo.ca.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gilliland', 'Affiliation': 'Human Environments Analysis Laboratory, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Leckie', 'Affiliation': 'School of Food and Nutritional Sciences, Brescia University College at The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Human Environments Analysis Laboratory, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Jamie A', 'Initials': 'JA', 'LastName': 'Seabrook', 'Affiliation': 'Human Environments Analysis Laboratory, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Madill', 'Affiliation': 'Human Environments Analysis Laboratory, The University of Western Ontario, London, Ontario, Canada.'}]",Lifestyle genomics,['10.1159/000510216']
332,33004464,The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial.,"OBJECTIVE


To explore the effects of empagliflozin on the incidence of obstructive sleep apnea (OSA) and its effects on metabolic, cardiovascular (CV), and renal outcomes among participants with or without OSA in the EMPA-REG OUTCOME trial.
RESEARCH DESIGN AND METHODS


Participants with diabetes and CV disease were randomized to empagliflozin (10 and 25 mg) or placebo daily in addition to standard of care. OSA was assessed by investigator report using Medical Dictionary for Regulatory Activities version 18.0, and CV outcomes were independently adjudicated. Analyses were performed using multivariable-adjusted Cox regression models.
RESULTS


OSA was reported in 391 of 7,020 (5.6%) participants at baseline. Those with OSA were more likely to be male (83% vs. 71%) and to have moderate to severe obesity (BMI ≥35 kg/m 2 ; 55% vs. 18%). Over a median of 3.1 years, empagliflozin had similar placebo-adjusted reductions in HbA 1c , waist circumference, and systolic blood pressure, regardless of OSA status, but a larger effect on weight (adjusted mean ± SE difference at week 52: OSA vs. no OSA -2.9 ± 0.5 vs. -1.9 ± 0.1 kg). Incidence of 3-point major adverse CV events, CV death, heart failure hospitalization, and incident or worsening nephropathy in the placebo group was 1.2- to 2.0-fold higher for those with baseline OSA compared with those without. Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all >0.05). Fifty patients reported a new diagnosis of OSA through 7 days after medication discontinuation, and this occurred less often with empagliflozin treatment (hazard ratio 0.48 [95% CI 0.27, 0.83]).
CONCLUSIONS


In EMPA-REG OUTCOME, participants with OSA had greater comorbidity and higher frequency of CV and renal events. Empagliflozin had favorable effects on risk factors and CV and renal outcomes regardless of preexisting OSA and may also reduce the risk for new-onset OSA.",2020,Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all > 0.05).,"['participants with or without OSA in the EMPA-REG OUTCOME trial', 'Participants with diabetes and CV disease']","['placebo', 'Empagliflozin', 'empagliflozin']","['new diagnosis of OSA', 'OSA status', 'comorbidity and higher frequency of CV and renal events', 'HbA 1c , waist circumference, and systolic blood pressure, regardless of OSA status', 'moderate-severe obesity', 'Incidence of 3-point major adverse CV events, CV death, heart failure hospitalization, and incident or worsening nephropathy', 'metabolic, cardiovascular (CV), and renal outcomes', 'OSA', 'Obstructive Sleep Apnea, Cardiovascular, and Renal Outcomes', 'obstructive sleep apnea (OSA']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.196974,Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all > 0.05).,"[{'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Neeland', 'Affiliation': 'University Hospitals Harrington Heart and Vascular Institute and Case Western Reserve University School of Medicine, Cleveland, OH ian.neeland@uhhospitals.org.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Eliasson', 'Affiliation': 'Department of Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine I (Cardiology), RWTH University Hospital, Aachen, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Wuerzburg University Clinic, Wuerzburg, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Wojeck', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Henry K', 'Initials': 'HK', 'LastName': 'Yaggi', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-1096']
333,32996096,"Repository Corticotropin Injection for Persistently Active Systemic Lupus Erythematosus: Results from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.","INTRODUCTION


We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar ®  Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids.
METHODS


This multicenter, double-blind, randomized, placebo-controlled study enrolled patients ≥ 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5-30 mg/day prednisone equivalent) and antimalarials for ≥ 4 weeks and/or immunosuppressants for ≥ 8 weeks before screening. Stable glucocorticoid doses were required through week 16 with optional taper from weeks 16 to 24. Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24. Endpoints included the proportion of SLE Responder Index (SRI)-4 responders at week 16; changes from baseline to week 16 in 28 Swollen Joint Count/Tender Joint Count (28 SJC/TJC) and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-Activity score; and changes from baseline to week 24 in inflammatory cytokines. Safety was assessed by adverse events.
RESULTS


In the modified intention-to-treat population (RCI, n = 84; placebo, n = 85), the proportion of SRI-4 responders at week 16 was not significantly different between groups (RCI, 47.6%; placebo, 43.5%; OR [95% CI] 1.2 [0.6 to 2.2]; p = 0.5762). RCI treatment resulted in a reduction from baseline to week 16 in 28 SJC/TJC and CLASI-Activity score and from baseline to week 8 in a proliferation-inducing ligand cytokine. Post hoc analyses demonstrated a greater proportion of BILAG-based Combined Lupus Assessment responders for RCI than placebo at weeks 4, 12, and 20 and greater SRI-4 response in RCI-treated patients with baseline SLE Disease Activity Index-2000 ≥ 10 and CLASI-Activity ≥ 11. No new safety signals were identified.
CONCLUSIONS


Despite failure to achieve the primary endpoint, these results support the utility of RCI for treating persistently active SLE.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT02953821.",2020,RCI treatment resulted in a reduction from baseline to week 16 in 28 SJC/TJC and CLASI-Activity score and from baseline to week 8 in a proliferation-inducing ligand cytokine.,"['Active Systemic Lupus Erythematosus', 'persistently active systemic lupus erythematosus (SLE', 'enrolled patients\u2009≥', '18\xa0years with active SLE and moderate\xa0to\xa0severe rash and/or arthritis despite stable']","['RCI subcutaneously or placebo', 'Repository Corticotropin Injection', 'repository corticotropin injection (RCI; Acthar ®  Gel', 'placebo', 'glucocorticoid', 'Placebo']","['Safety', 'proportion of SLE Responder Index (SRI)-4 responders', 'Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-Activity score', 'TJC and CLASI-Activity score', 'efficacy and safety', 'proportion of SRI-4 responders', 'SRI-4 response']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0718234', 'cui_str': 'Acthar'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024137', 'cui_str': 'Cutaneous lupus erythematosus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.499077,RCI treatment resulted in a reduction from baseline to week 16 in 28 SJC/TJC and CLASI-Activity score and from baseline to week 8 in a proliferation-inducing ligand cytokine.,"[{'ForeName': 'Anca D', 'Initials': 'AD', 'LastName': 'Askanase', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA. ada20@cumc.columbia.edu.'}, {'ForeName': 'Enxu', 'Initials': 'E', 'LastName': 'Zhao', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Bilyk', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Furie', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}]",Rheumatology and therapy,['10.1007/s40744-020-00236-1']
334,33000415,Effect and Safety of Tongyan Spray () on Hyoid Motion in Patients with Dysphagia after Ischemic Stroke.,"OBJECTIVE


To observe the effects and safety of Tongyan Spray () on the range and time of hyoid motion in patients with ischemic post-stroke dysphagia.
METHODS


Seventy-two patients with ischemic post-stroke dysphagia were selected and randomly assigned to a treatment group (36 cases) and a control group (36 cases) by a random number table from January 2013 to October 2014. All patients swallowed 4 kinds of barium meals with different traits respectively, and each patient underwent video fluoroscopy (VF) examination twice. In the treatment group, Tongyan Spray was sprayed to the pharynx on both sides and the middle part once respectively. The spray was applied 30 min before the second examination. Purified water at room temperature was used as placebo in the control group. The changes in the range and time of hyoid motion in both groups were observed before and after treatment.
RESULTS


Six patients dropped out in each group, and 60 patients completed the study and were included in the final analysis. Significant improvement was observed in the range of superior hyoid excursion distance and the time of hyoid motion in the treatment group compared with the control group (P<0.05). There were no obvious adverse reactions observed in oral mucosa in both groups during the whole study.
CONCLUSION


Tongyan Spray was an effective and safe medicine for improving swallowing function in patients with ischemic post-stroke dysphagia.",2021,Significant improvement was observed in the range of superior hyoid excursion distance and the time of hyoid motion in the treatment group compared with the control group (P<0.05).,"['Six patients dropped out in each group, and 60 patients completed the study and were included in the final analysis', 'patients with ischemic post-stroke dysphagia', 'Patients with Dysphagia after Ischemic Stroke', 'Seventy-two patients with ischemic post-stroke dysphagia']","['video fluoroscopy (VF) examination twice', 'placebo', 'Tongyan Spray ']","['adverse reactions', 'range and time of hyoid motion', 'swallowing function', 'range of superior hyoid excursion distance and the time of hyoid motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C4319632', 'cui_str': '72'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020417', 'cui_str': 'Hyoid bone structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",72.0,0.0243368,Significant improvement was observed in the range of superior hyoid excursion distance and the time of hyoid motion in the treatment group compared with the control group (P<0.05).,"[{'ForeName': 'Wen-Jie', 'Initials': 'WJ', 'LastName': 'Hao', 'Affiliation': 'Department of Encephalopathy, Beijing Hospital of Integrated Traditional Chinese and Western Medicine, Beijing, 100039, China.'}, {'ForeName': 'Bing-Jie', 'Initials': 'BJ', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, China Rehabilitation Research Center, Beijing, 100068, China.'}, {'ForeName': 'Xiao-Lei', 'Initials': 'XL', 'LastName': 'Wu', 'Affiliation': 'Department of Encephalopathy, Beijing Hospital of Integrated Traditional Chinese and Western Medicine, Beijing, 100039, China.'}, {'ForeName': 'Zhen-Bo', 'Initials': 'ZB', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, China Rehabilitation Research Center, Beijing, 100068, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The 3rd Department of Neurorehabilitation, China Rehabilitation Research Center, Beijing, 100068, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Department of Radiology, China Rehabilitation Research Center, Beijing, 100068, China.'}, {'ForeName': 'Wen-Yan', 'Initials': 'WY', 'LastName': 'Zhang', 'Affiliation': 'Department of Encephalopathy, Beijing Hospital of Integrated Traditional Chinese and Western Medicine, Beijing, 100039, China.'}, {'ForeName': 'Xue-Gong', 'Initials': 'XG', 'LastName': 'Feng', 'Affiliation': 'Department of Encephalopathy, Beijing Hospital of Integrated Traditional Chinese and Western Medicine, Beijing, 100039, China. bjcwhfxg@sina.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3325-y']
335,33010116,Ingestion of an exogenous ketone monoester improves the glycemic response during oral glucose tolerance test in individuals with impaired glucose tolerance: A cross-over randomized trial.,"AIMS/INTRODUCTION


As a low-carbohydrate diet and the use of sodium-glucose transporter-2 inhibitors are both known to increase D-beta-hydroxybutyrate levels, the effect of these levels on glucose metabolism has attracted attention. We investigated the acute effects of ketone monoester (KM) ingestion on blood glucose levels during the 75-g oral glucose tolerance test (OGTT) in participants with impaired glucose tolerance.
MATERIALS AND METHODS


Nine Japanese adults aged 48-62 years (4 men, 5 women) with impaired glucose tolerance participated in this study. After participants fasted overnight, we carried out OGTT for 180 min with and without KM ingestion on two separate days in a randomized cross-over design. We compared the area under the curve (AUC) of D-beta-hydroxybutyrate, glucose, insulin, C-peptide, glucagon and free fatty acids during OGTT.
RESULTS


The AUC of D-beta-hydroxybutyrate during OGTT was significantly higher with KM than without KM (KM 5995.3 ± 1257.1 mmol/L·h; without KM 116.1 ± 33.9 mmol/L·h, P < 0.0001), and the AUC of glucose with KM was significantly lower than that without KM (KM 406.6 ± 70.6 mg/dL·h; without KM 483.2 ± 74.3 mg/dL·h, P < 0.0001). This improved glucose excursion was associated with enhanced AUC of insulin during the first half (0-90 min) of OGTT, even though the AUC of C-peptide during this period was unchanged. In contrast, the AUC of insulin, C-peptide, glucagon and free fatty acids during 180 min of OGTT were similar in both conditions.
CONCLUSION


The ingestion of KM decreased the AUC of glucose during 75-g OGTT in Japanese individuals with impaired glucose tolerance, and the mechanism might involve elevated levels of circulating early phase insulin.",2021,"The AUC-βHB during OGTT was significantly higher with KM than without KM (KM, 5995.3 ± 1257.1 mmo/L h; without KM, 116.1 ± 33.9 mmo/L·h , P<0.0001), and the AUC-glucose with KM was significantly lower than that without KM (KM, 406.6 ± 70.6 mg/dL h; without KM, 483.2 ± 74.3 mg/dL·h, P<0.0001).","['Subjects with Impaired Glucose Tolerance', 'Nine Japanese adults aged 48-62 years (4 male, 5 female) with IGT participated in this study', 'participants with impaired glucose tolerance (IGT']","['75-g oral glucose tolerance testing (OGTT', 'ketone monoester (KM) ingestion', 'Exogenous Ketone Monoester']","['ingestion of KM decreased AUC-glucose', 'glucose excursion', 'blood glucose levels', 'AUC-glucose with KM', 'enhanced AUC-insulin', 'Glycemic Response', 'AUC-insulin, C-peptide, glucagon, and FFA', 'area under the curve (AUC) of βHB, glucose, insulin, C-peptide, glucagon, and free fatty acids (FFA']","[{'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}]",9.0,0.0503961,"The AUC-βHB during OGTT was significantly higher with KM than without KM (KM, 5995.3 ± 1257.1 mmo/L h; without KM, 116.1 ± 33.9 mmo/L·h , P<0.0001), and the AUC-glucose with KM was significantly lower than that without KM (KM, 406.6 ± 70.6 mg/dL h; without KM, 483.2 ± 74.3 mg/dL·h, P<0.0001).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakagata', 'Affiliation': 'Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Tamura', 'Affiliation': 'Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideyoshi', 'Initials': 'H', 'LastName': 'Kaga', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Motonori', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Someya', 'Affiliation': 'Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Satoh', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ryuzo', 'Initials': 'R', 'LastName': 'Kawamori', 'Affiliation': 'Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13423']
336,33007492,Sinus augmentation - autograft vs. fresh frozen allograft: Bone density dynamics and implant stability.,"OBJECTIVES


Compare bone density changes and initial implant stability following sinus augmentation with autogenous bone (AB) vs. fresh frozen bone (FFB).
MATERIALS AND METHODS


Randomized, prospective, split mouth study. Sinus augmentation executed using either AB or FFB. Dental implants were inserted after 6 months of healing. Implant dimensions and insertion torques were recorded. Prostheses were delivered 6 months thereafter. All patients had computerized tomography (CT) scans 1 week (T1) and 6 months (T2) after initial bone grafting. Third CT (T3) was taken 12 months after prosthesis delivery. Data from CT scans was used to analyze bone density at each period.
RESULTS


A total of 15 patients (8 males, 7 females) following bilateral sinus augmentation procedures, were included. Mean age was 54 ± 5 years (range 48-60 years). All patients had 3 CT examinations. The initial augmented AB density was higher than the initial FFB density. Nevertheless, density differences between the two groups were not statistically significant at any time frame. At T2 density of both grafts showed a statistically significant increase. A significant increase from T2 to T3 was noted only for the FFB group. Implant insertion torque was significantly higher in the FFB group. Insertion torque ≥32 N/cm was achieved in significantly more patients in the FFB group.
CONCLUSION


The use of FFB for sinus augmentation is a reliable option of graft material. The newly formed bone quality performance, evaluated by CBCT density, is as good as AB, allowing predictable initial implant stability and osseointegration. Unnecessary morbidity associated with AB harvesting is thus avoided.",2021,Implant insertion torque was significantly higher in the FFB group.,"['Mean age was 54\u2009±\u20095 years (range 48-60 years', 'All patients had 3 CT examinations', '15 patients (8 males, 7 females) following bilateral sinus augmentation procedures, were included']","['Sinus augmentation - autograft vs. fresh frozen allograft', 'sinus augmentation with autogenous bone (AB) vs. fresh frozen bone (FFB', 'FFB', 'AB or FFB']","['AB density', 'Implant insertion torque', 'Implant dimensions and insertion torques']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C2236586', 'cui_str': 'Sinus augmentation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2236586', 'cui_str': 'Sinus augmentation'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",15.0,0.0277306,Implant insertion torque was significantly higher in the FFB group.,"[{'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Chaushu', 'Affiliation': 'Attending, Department of Periodontology and Implant Dentistry, School of Dentistry, Tel Aviv University, Israel. Electronic address: liat.natanel@gmail.com.'}, {'ForeName': 'Erick Ricardo', 'Initials': 'ER', 'LastName': 'Silva', 'Affiliation': 'Attending, Department of Oral and Maxillofacial Surgery and Periodontology School of Dentistry of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: erickricardo.rp@gmail.com.'}, {'ForeName': 'Vitor Ferreira', 'Initials': 'VF', 'LastName': 'Balan', 'Affiliation': 'MSc Student in Oral and Maxillofacial Surgery - Dental School of University of Sao Paulo - Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: vitor.balan@usp.br.'}, {'ForeName': 'Gavriel', 'Initials': 'G', 'LastName': 'Chaushu', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, School of Dental Medicine, Tel Aviv University, Tel-Aviv, Department of Oral & Maxillofacial Surgery, Rabin Medical Center, Campus Beilinson, Petah Tiqwa, Israel. Electronic address: gabi.chaushu@gmail.com.'}, {'ForeName': 'Samuel Porfirio', 'Initials': 'SP', 'LastName': 'Xavier', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology. School of Dentistry of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: samuelpxavier@yahoo.com.br.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2020.08.012']
337,33009665,"No ""Wearing-Off Effect"" Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long-Term Study.","OBJECTIVE


To evaluate whether quarterly or monthly administration of fremanezumab for migraine prevention exhibits a pattern of decreased efficacy toward the end of the dosing interval (wearing-off effect).
BACKGROUND


The main goals of migraine preventive treatment are to reduce the frequency, severity, and duration of migraine attacks, and migraine-associated disability. Wearing-off refers to the phenomenon whereby clinical symptoms return or worsen before the next dose of a drug is due and has been reported previously with migraine preventive medications.
DESIGN AND METHODS


This was a long-term, 12-month, multicenter, randomized, double-blind, parallel-group phase 3 study (NCT02638103) that included chronic (CM) and episodic migraine (EM) patients who rolled over from the 12-week phase 3 HALO CM (NCT02621931) and EM trials (NCT02629861), as well as an additional subset of 312 new patients. Patients with CM or EM received fremanezumab either monthly or quarterly. In this post hoc analysis, for selected months, the difference in the average number of migraine days between weeks 1-2 and weeks 3-4, between weeks 1-3 and week 4, and between weeks 1-2 and weeks 11-12 were calculated.
RESULTS


A total of 1890 patients (CM, 1110; EM, 780) were enrolled. At months 3, 6, 9, and 15, there were no substantial differences in mean weekly migraine days between weeks 1-2 and weeks 3-4 or between weeks 1-3 and week 4 with quarterly or monthly fremanezumab in the CM or EM subgroups. There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups. Across both dosing subgroups in CM and EM patients, the mean weekly number of migraine days decreased substantially (30%-42%) during the first 2 weeks; decreases in weekly migraine days remained steady during the last 2 weeks of the first quarter, with a similar maintenance of response during the second quarter.
CONCLUSIONS


This analysis of data from a long-term, phase 3 study showed that patients receiving quarterly fremanezumab or monthly fremanezumab did not experience a wearing-off effect toward the end of the dosing interval.",2020,There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups.,"['1890 patients (CM, 1110; EM, 780 ) were enrolled', 'included chronic (CM) and episodic migraine (EM) patients who rolled over from the 12-week Phase 3 HALO CM (NCT02621931) and EM trials (NCT02629861), as well as an additional subset of 312 new patients']","['Fremanezumab', 'fremanezumab']","['mean weekly number of migraine days', 'average number of migraine days', 'mean weekly migraine days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0543436', 'cui_str': 'Does roll over'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",1890.0,0.0446177,There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups.,"[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Blumenfeld', 'Affiliation': 'The Headache Center of Southern California, The Neurology Center, Carlsbad, CA, USA.'}, {'ForeName': 'Darko M', 'Initials': 'DM', 'LastName': 'Stevanovic', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ortega', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Seminerio', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}]",Headache,['10.1111/head.13994']
338,33002438,"Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial.","BACKGROUND


Adjuvant radiotherapy reduces the risk of biochemical progression in prostate cancer patients after radical prostatectomy. We aimed to compare adjuvant versus early salvage radiotherapy after radical prostatectomy, combined with short-term hormonal therapy, in terms of oncological outcomes and tolerance.
METHODS


GETUG-AFU 17 was a randomised, open-label, multicentre, phase 3 trial done at 46 French hospitals. Men aged at least 18 years who had an Eastern Cooperative Oncology Group performance status of 1 or less, localised adenocarcinoma of the prostate treated with radical prostatectomy, who had pathologically-staged pT3a, pT3b, or pT4a (with bladder neck invasion), pNx (without pelvic lymph nodes dissection), or pN0 (with negative lymph nodes dissection) disease, and who had positive surgical margins were eligible for inclusion in the study. Eligible patients were randomly assigned (1:1) to either immediate adjuvant radiotherapy or delayed salvage radiotherapy at the time of biochemical relapse. Random assignment, by minimisation, was done using web-based software and stratified by Gleason score, pT stage, and centre. All patients received 6 months of triptorelin (intramuscular injection every 3 months). The primary endpoint was event-free survival. Efficacy and safety analyses were done on the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT00667069.
FINDINGS


Between March 7, 2008, and June 23, 2016, 424 patients were enrolled. We planned to enrol 718 patients, with 359 in each study group. However, on May 20, 2016, the independent data monitoring committee recommended early termination of enrolment because of unexpectedly low event rates. At database lock on Dec 19, 2019, the overall median follow-up time from random assignment was 75 months (IQR 50-100), 74 months (47-100) in the adjuvant radiotherapy group and 78 months (52-101) in the salvage radiotherapy group. In the salvage radiotherapy group, 115 (54%) of 212 patients initiated study treatment after biochemical relapse. 205 (97%) of 212 patients started treatment in the adjuvant group. 5-year event-free survival was 92% (95% CI 86-95) in the adjuvant radiotherapy group and 90% (85-94) in the salvage radiotherapy group (HR 0·81, 95% CI 0·48-1·36; log-rank p=0·42). Acute grade 3 or worse toxic effects occurred in six (3%) of 212 patients in the adjuvant radiotherapy group and in four (2%) of 212 patients in the salvage radiotherapy group. Late grade 2 or worse genitourinary toxicities were reported in 125 (59%) of 212 patients in the adjuvant radiotherapy group and 46 (22%) of 212 patients in the salvage radiotherapy group. Late genitourinary adverse events of grade 2 or worse were reported in 58 (27%) of 212 patients in the adjuvant radiotherapy group versus 14 (7%) of 212 patients in the salvage radiotherapy group (p<0·0001). Late erectile dysfunction was grade 2 or worse in 60 (28%) of 212 in the adjuvant radiotherapy group and 17 (8%) of 212 in the salvage radiotherapy group (p<0·0001).
INTERPRETATION


Although our analysis lacked statistical power, we found no benefit for event-free survival in patients assigned to adjuvant radiotherapy compared with patients assigned to salvage radiotherapy. Adjuvant radiotherapy increased the risk of genitourinary toxicity and erectile dysfunction. A policy of early salvage radiotherapy could spare men from overtreatment with radiotherapy and the associated adverse events.
FUNDING


French Health Ministry and Ipsen.",2020,"5-year event-free survival was 92% (95% CI 86-95) in the adjuvant radiotherapy group and 90% (85-94) in the salvage radiotherapy group (HR 0·81, 95% CI 0·48-1·36; log-rank p=0·42).","['Eligible patients', 'prostate cancer patients after radical prostatectomy', 'men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17', 'Men aged at least 18 years who had an Eastern Cooperative Oncology Group performance status of 1 or less, localised adenocarcinoma of the prostate treated with radical prostatectomy, who had pathologically-staged pT3a, pT3b, or pT4a (with bladder neck invasion), pNx (without pelvic lymph nodes dissection), or pN0 (with negative lymph nodes dissection) disease, and who had positive surgical margins were eligible for inclusion in the study', 'GETUG-AFU 17 was a randomised, open-label, multicentre, phase 3 trial done at 46 French hospitals', '718 patients, with 359 in each study group', 'Between March 7, 2008, and June 23, 2016, 424 patients were enrolled']","['salvage radiotherapy plus short-term androgen deprivation therapy', 'adjuvant versus early salvage radiotherapy after radical prostatectomy, combined with short-term hormonal therapy', 'adjuvant radiotherapy', 'Adjuvant radiotherapy', 'triptorelin', 'salvage radiotherapy', 'radiotherapy', 'immediate adjuvant radiotherapy or delayed salvage radiotherapy']","['5-year event-free survival', 'Late erectile dysfunction', 'risk of genitourinary toxicity and erectile dysfunction', 'Late grade 2 or worse genitourinary toxicities', 'Acute grade 3 or worse toxic effects', 'Late genitourinary adverse events', 'event-free survival', 'Efficacy and safety analyses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0227716', 'cui_str': 'Structure of neck of urinary bladder'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",424.0,0.16146,"5-year event-free survival was 92% (95% CI 86-95) in the adjuvant radiotherapy group and 90% (85-94) in the salvage radiotherapy group (HR 0·81, 95% CI 0·48-1·36; log-rank p=0·42).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sargos', 'Affiliation': 'Institut Bergonié, Bordeaux, France. Electronic address: p.sargos@bordeaux.unicancer.fr.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chabaud', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Latorzeff', 'Affiliation': 'Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Magné', 'Affiliation': 'Institut de Cancérologie de la Loire, Saint-Priest-en-Jarèz, France.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Benyoucef', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Supiot', 'Affiliation': ""Institut de Cancérologie de l'Ouest, Site René Gauducheau, Saint-Herblain, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pasquier', 'Affiliation': 'Centre Oscar Lambret and Lille University, Lille, France.'}, {'ForeName': 'Menouar Samir', 'Initials': 'MS', 'LastName': 'Abdiche', 'Affiliation': 'Centre Hospitalier Robert Boulin, Libourne, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Gilliot', 'Affiliation': 'Clinique Marzet, Pau, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff-Cailleaud', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Centre François Baclesse, Caen, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bergerot', 'Affiliation': ""Clinique Mutualiste de l'Estuaire, Cité Sanitaire, Saint-Nazaire, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Baumann', 'Affiliation': ""Centre d'Oncologie de Gentilly, Nancy, France.""}, {'ForeName': 'Yazid', 'Initials': 'Y', 'LastName': 'Belkacemi', 'Affiliation': 'Hôpitaux Universitaires Henri Mondor, Université Paris Est Créteil, Creteil, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Azria', 'Affiliation': ""Institut Régional du Cancer de Montpellier Val d'Aurelle, Montpellier, France.""}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Brihoum', 'Affiliation': 'Unicancer, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Soulié', 'Affiliation': 'CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Richaud', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30454-X']
339,33012658,How long does the fertility-enhancing effect of hysterosalpingography with oil-based contrast last?,"RESEARCH QUESTION


Does the fertility-enhancing effect of tubal flushing during hysterosalpingography (HSG) with oil-based contrast change over time?
DESIGN


This was a secondary analysis of the H2Oil (long-term follow-up) study, a multicentre randomized controlled trial evaluating the effectiveness of oil-based and water-based contrast during HSG. The main outcome was ongoing pregnancy. Cox proportional hazards models for time to ongoing pregnancy were fitted over 3 years of follow-up.
RESULTS


Data on 1107 couples were available; 550 couples had oil-based contrast and 557 water-based contrast at HSG. Ongoing pregnancy rates after 3 years were 77% and 71%, respectively. Median follow-up was 9-10 months (5th-95th percentile: <1 to 36). The hazard ratio for ongoing pregnancy for oil versus water over 3 years of follow-up was 1.26 (95% confidence interval [CI] 1.10-1.45). The scaled Schoenfeld residual plots showed a decrease in hazard ratio that was linear with log-transformed time. After including an interaction with log-transformed time, the hazard ratio immediately after HSG was 1.71 (95% CI 1.27-2.31) and reduced to no effect (hazard ratio of 1) at approximately 2 years. There was no evidence for a change in hazard ratio over time in a subgroup of women who experienced pain during HSG.
CONCLUSIONS


The hazard ratio for ongoing pregnancy of oil-based versus water-based contrast was 1.71 immediately after HSG, gradually decreasing and plateauing towards a hazard ratio of 1 (indicating no effect) after approximately 2 years. This supports the hypothesis that oil-based contrast might dislodge debris or mucus plugs from the Fallopian tubes, but this has yet to be definitively proved.",2020,"There was no evidence for a change in hazard ratio over time in a subgroup of women who experienced pain during HSG.
",['1107 couples were available; 550 couples had oil-based contrast and 557 water-based contrast at HSG'],['oil-based and water-based contrast during HSG'],"['hazard ratio for ongoing pregnancy', 'Ongoing pregnancy rates', 'hazard ratio']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",1107.0,0.148688,"There was no evidence for a change in hazard ratio over time in a subgroup of women who experienced pain during HSG.
","[{'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands. Electronic address: n.vanwelie@amsterdamumc.nl.'}, {'ForeName': 'Kimmy', 'Initials': 'K', 'LastName': 'Rosielle', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joukje', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelis B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'van Geloven', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Velja', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'van Eekelen', 'Affiliation': 'Centre for Reproductive Medicine, Amsterdam UMC, University of Amsterdam Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.08.038']
340,33022140,Clinical and demographic characteristics of people who smoke versus inject crystalline methamphetamine in Australia: Findings from a pharmacotherapy trial.,"INTRODUCTION AND AIMS


There has been a rapid increase in smoking crystalline methamphetamine in Australia. We compare the clinical and demographic characteristics of those who smoke versus inject the drug in a cohort of people who use methamphetamine.
DESIGN AND METHODS


Participants (N = 151) were dependent on methamphetamine, aged 18-60 years, enrolled in a pharmacotherapy trial for methamphetamine dependence, and reported either injecting (n = 54) or smoking (n = 97) methamphetamine. Measures included the Timeline Followback, Severity of Dependence Scale, Amphetamine Withdrawal Questionnaire, Craving Experience Questionnaire and the Brief Psychiatric Rating Scale (symptoms of depression, hostility, psychosis and suicidality). Simultaneous regression was used to identify independent demographic correlates of smoking methamphetamine and to compare the clinical characteristics of participants who smoked versus injected.
RESULTS


Compared to participants who injected methamphetamine, those who smoked methamphetamine were younger and less likely to be unemployed, have a prison history or live alone. Participants who smoked methamphetamine used methamphetamine on more days in the past 4 weeks than participants who injected methamphetamine (26 vs. 19 days, P = 0.001); they did not differ significantly in their severity of methamphetamine dependence, withdrawal, craving or psychiatric symptoms (P > 0.05). After adjustment for demographic differences, participants who smoked had lower craving [b (SE) = -1.1 (0.5), P = 0.021] and were less likely to report psychotic symptoms [b (SE) = -1.8 (0.7), P = 0.013] or antidepressant use [b (SE) = -1.1 (0.5), P = 0.022].
DISCUSSION AND CONCLUSIONS


Smoking crystalline methamphetamine is associated with a younger less marginalised demographic profile than injecting methamphetamine, but a similarly severe clinical profile.",2021,"DISCUSSION AND CONCLUSIONS


Smoking crystalline methamphetamine is associated with a younger less marginalised demographic profile than injecting methamphetamine, but a similarly severe clinical profile.","['people who smoke versus inject crystalline methamphetamine in Australia', 'participants who smoked versus injected', 'Participants (N = 151) were dependent on methamphetamine, aged 18-60\u2009years, enrolled in a pharmacotherapy trial for methamphetamine dependence, and reported either injecting (n = 54) or smoking (n = 97']","['antidepressant use [b (SE) ', 'methamphetamine']","['severity of methamphetamine dependence, withdrawal, craving or psychiatric symptoms', 'Timeline Followback, Severity of Dependence Scale, Amphetamine Withdrawal Questionnaire, Craving Experience Questionnaire and the Brief Psychiatric Rating Scale (symptoms of depression, hostility, psychosis and suicidality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0236665', 'cui_str': 'Amphetamine withdrawal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",151.0,0.0762108,"DISCUSSION AND CONCLUSIONS


Smoking crystalline methamphetamine is associated with a younger less marginalised demographic profile than injecting methamphetamine, but a similarly severe clinical profile.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McKETIN', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Quinn', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Higgs', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Alyna', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Dan I', 'Initials': 'DI', 'LastName': 'Lubman', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Carter', 'Affiliation': 'Centre for Brain and Mental Health Priority Research Centre, School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'Centre for Brain and Mental Health Priority Research Centre, School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Manning', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Ramez', 'Initials': 'R', 'LastName': 'Bathish', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Dayle', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Saunders', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wrobel', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Alcyone', 'Initials': 'A', 'LastName': 'Meehan', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Sinclair', 'Affiliation': 'Drug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reid', 'Affiliation': 'Drug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Arunogiri', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'Mental Health and Drug and Alcohol Services, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cordaro', 'Affiliation': 'Drug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Dietze', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Australia.'}]",Drug and alcohol review,['10.1111/dar.13183']
341,33011964,Long-Term Treatment with Apixaban in Patients with Atrial Fibrillation: Outcomes during the Open-Label Extension following AVERROES.,"BACKGROUND


AVERROES, a randomized controlled trial in high-risk patients with atrial fibrillation, unsuitable for vitamin K antagonist therapy, demonstrated efficacy and safety of apixaban compared with aspirin. At the conclusion of the double-blind phase, an open-label extension was initiated to allow study participants to receive apixaban until it became locally available. This study reports outcomes of patients on apixaban during the open-label extension.
METHODS


Rates of stroke or systemic embolism, hemorrhagic stroke, major bleeding, and other outcomes during the open-label extension are reported.
RESULTS


Of the 5,599 participants enrolled in AVERROES, 3,275 (58.5%) received apixaban during the open-label extension. Median (interquartile range) follow-up in the open-label extension was 3.0 (2.5-3.5) years. The rate of stroke or systemic embolism during the open-label extension was 1.0% per year, and the annual rates of hemorrhagic stroke and major bleeding were 0.3 and 1.2%, respectively. After adjustment for imbalances in patient variables, event rates in patients on apixaban during the open-label extension were similar to those of patients receiving apixaban during AVERROES. Additional analyses in all patients who received apixaban, at any time from the start of AVERROES to the end of the open-label extension, were performed. This cohort ( n  = 4,414) showed annual event rates of 1.1% for stroke or systemic embolism, 0.3% for hemorrhagic stroke, and 1.2% for major bleeding.
CONCLUSION


During the open-label extension, annual rates of stroke or systemic embolism, hemorrhagic stroke, and major bleeding remained as low as those observed during apixaban treatment in AVERROES. These data support the long-term efficacy and safety of apixaban in patients with atrial fibrillation.",2021,"This cohort ( n  = 4,414) showed annual event rates of 1.1% for stroke or systemic embolism, 0.3% for hemorrhagic stroke, and 1.2% for major bleeding.
","['high-risk patients with atrial fibrillation', '5,599 participants enrolled in AVERROES, 3,275 (58.5%) received', 'patients on apixaban during the open-label extension', 'Patients with Atrial Fibrillation', 'patients with atrial fibrillation']","['apixaban', 'vitamin K antagonist therapy', 'Apixaban', 'aspirin']","['stroke or systemic embolism, hemorrhagic stroke, major bleeding', 'hemorrhagic stroke', 'annual rates of stroke or systemic embolism, hemorrhagic stroke, and major bleeding', 'rate of stroke or systemic embolism', 'hemorrhagic stroke and major bleeding']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",5599.0,0.0769026,"This cohort ( n  = 4,414) showed annual event rates of 1.1% for stroke or systemic embolism, 0.3% for hemorrhagic stroke, and 1.2% for major bleeding.
","[{'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Benz', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Division Clinical Electrophysiology, Department of Cardiology, Johann Wolfgang Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Kahl', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, New Jersey, Unites States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Beresh', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Balasubramanian', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}]",Thrombosis and haemostasis,['10.1055/s-0040-1717115']
342,33279544,Vicryl Mesh Coverage Reduced Recurrence After Bullectomy for Primary Spontaneous Pneumothorax.,"BACKGROUND


Although thoracoscopic stapled bullectomy is a standard procedure for primary spontaneous pneumothorax (PSP), the postoperative recurrence rate is high. We investigated whether using a Vicryl (Ethicon, Somerville, NJ) mesh to cover the staple line after bullectomy reduces the postoperative recurrence rate.
METHODS


Our single-blind, parallel-group, prospective, randomized controlled trial at 2 medical centers in Taiwan studied patients with PSP who were aged 15 to 50 years and required thoracoscopic bullectomy. On the day of operation, patients were randomly assigned (1:1) to receive Vicryl mesh (mesh group) or not (control group) after thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion. Randomization was achieved using computer-generated random numbers in sealed envelopes. Our primary end point was the pneumothorax recurrence rate within 1 year after the operation (clinicaltrials.gov number, NCT01848860.) RESULTS: Between June 2013 and March 2016, 102 patients were assigned to the mesh group and 102 to the control group. Within 1 year after operation, recurrent pneumothorax was diagnosed in 3 patients (2.9%) in the mesh group compared with 16 (15.7%) in the control group (P = .005). The short-term postoperative results and hospitalization duration were comparable between the groups.
CONCLUSIONS


For thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion, the use of a Vicryl mesh to cover the staple line is effective for reducing the postoperative recurrence of pneumothorax. Vicryl mesh coverage can be considered an optimal adjunct to the standard surgical procedure for PSP.",2021,"The short-term postoperative results and hospitalization duration were comparable between the groups.
","['two medical centers in Taiwan, patients with PSP who were aged 15-50 years and required thoracoscopic bullectomy were studied', 'primary spontaneous pneumothorax', 'primary spontaneous pneumothorax (PSP', 'Between June 2013 and March 2016, 102 patients were assigned to the mesh group and 102 to the control group']","['vicryl mesh (mesh group) or not (control group) after thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion', 'bullectomy', 'thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion', 'thoracoscopic stapled bullectomy']","['recurrent pneumothorax', 'pneumothorax-recurrence rate', 'postoperative recurrence of pneumothorax', 'postoperative-recurrence rate', 'hospitalization duration']","[{'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868193', 'cui_str': 'Primary spontaneous pneumothorax'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0947694', 'cui_str': 'Vicryl'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0189563', 'cui_str': 'Pleural abrasion'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",102.0,0.11403,"The short-term postoperative results and hospitalization duration were comparable between the groups.
","[{'ForeName': 'Hsao-Hsun', 'Initials': 'HH', 'LastName': 'Hsu', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Yun-Hen', 'Initials': 'YH', 'LastName': 'Liu', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Hsuan-Yu', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Institute of Statistical Science, Academia Sinica, Taipei, Taiwan.'}, {'ForeName': 'Pei-Hsing', 'Initials': 'PH', 'LastName': 'Chen', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, National Taiwan University Hospital Yun-Lin Branch, Yun-Lin, Taiwan.'}, {'ForeName': 'Ke-Cheng', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Ming-Ju', 'Initials': 'MJ', 'LastName': 'Hsieh', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Mong-Wei', 'Initials': 'MW', 'LastName': 'Lin', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Shuenn-Wen', 'Initials': 'SW', 'LastName': 'Kuo', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Pei-Ming', 'Initials': 'PM', 'LastName': 'Huang', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Yin-Kai', 'Initials': 'YK', 'LastName': 'Chao', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Ching-Feng', 'Initials': 'CF', 'LastName': 'Wu', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Ching-Yang', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Wei-Hsun', 'Initials': 'WH', 'LastName': 'Chen', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chih-Tsung', 'Initials': 'CT', 'LastName': 'Wen', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chao-Yu', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Far-Eastern Memorial Hospital, New Taipei City, and Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yi-Cheng', 'Initials': 'YC', 'LastName': 'Wu', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan. Electronic address: expert96@cgmh.org.tw.'}, {'ForeName': 'Jin-Shing', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgical Oncology, National Taiwan University Cancer Center and National Taiwan University College of Medicine, Taipei, Taiwan.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.11.012']
343,33043148,Long-term outcomes of therapist-guided Internet-delivered cognitive behavior therapy for pediatric obsessive-compulsive disorder.,"Cognitive behavior therapy (CBT) is the recommended first-line intervention for children and adolescents with obsessive-compulsive disorder (OCD), but is not broadly accessible. Internet-delivered CBT (ICBT) with minimal therapist support is efficacious and cost-effective, at least in the short term. Whether the therapeutic gains of ICBT for OCD are sustained in the long run is unknown. In this study, 61 adolescents with OCD who participated in a randomized trial of ICBT were followed-up 3 and 12 months after treatment. The proportion of treatment responders and remitters remained stable from post-treatment to 3-month follow-up and increased significantly from 3-month to 12-month follow-up. This study suggests that the gains of ICBT for youth with OCD are not only maintained long-term, but that further improvements continue to occur during follow-up.",2020,The proportion of treatment responders and remitters remained stable from post-treatment to 3-month follow-up and increased significantly from 3-month to 12-month follow-up.,"['pediatric obsessive-compulsive disorder', 'children and adolescents with obsessive-compulsive disorder (OCD', '61 adolescents with OCD who participated in a randomized trial of']","['therapist-guided Internet-delivered cognitive behavior therapy', 'Internet-delivered CBT (ICBT', 'Cognitive behavior therapy (CBT', 'ICBT']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],61.0,0.0301225,The proportion of treatment responders and remitters remained stable from post-treatment to 3-month follow-up and increased significantly from 3-month to 12-month follow-up.,"[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Lenhard', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, 171 77 Region Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mataix-Cols', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, 171 77 Region Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rück', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, 171 77 Region Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Aspvall', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, 171 77 Region Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Serlachius', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, 171 77 Region Stockholm, Sweden.'}]",NPJ digital medicine,['10.1038/s41746-020-00327-x']
344,33039185,Impact of adding palatal rugae to complete dentures on patient satisfaction and oral health-related quality of life: A randomized crossover clinical trial.,"STATEMENT OF PROBLEM


The addition of palatal rugae to complete dentures has been suggested to improve the satisfaction of patients with different oral functions. However, clinical studies to support these claims are lacking.
PURPOSE


The purpose of this randomized, single-blind, 2-period crossover trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with complete dentures with palatal rugae compared with a polished palate.
MATERIAL AND METHODS


Edentulous patients aged 45 to 80 years, with no relevant medical conditions, seeking complete dentures at a university hospital between May and July 2019 were recruited. Each participant received new complete dentures. After a 1-week adaptation period, the participants were randomly allocated to 2 sequences through a computer-generated sequence. In the first sequence, palatal rugae were added to the complete dentures, and after 2 months, the palatal rugae were removed and the dentures used for another 2 months. In the second sequence, the opposite sequence was followed: polished palate first and palatal rugae second. After each period, a blinded dentist asked participants to rate their general satisfaction on a 100-mm visual analog scale (primary outcome) and to rate their satisfaction regarding eating, taste perception, speaking, phonetics, and ease of cleaning. Participants were also asked to fill the 20-item oral health impact profile for edentulous patients (OHIP-EDENT). The paired sample t test and the Wilcoxon test were used (α=.05).
RESULTS


Fifty participants were randomized, of whom 6 dropped out. No significant differences were found between ratings for the 2 palatal contours in terms of general satisfaction 2.32 (95% confidence interval: -3.65 to 8.29, P=.438), eating 1.70 (95% confidence interval: -4.05 to 7.46, P=.554), taste perception 0.57 (95% confidence interval -5.04 to 6.17, P=.839), phonetics 1.48 (95% confidence interval -4.46 to 7.41, P=.618), or speaking 3.68 (95% confidence interval: -1.92 to 9.28, P=.192). However, satisfaction with ease of cleaning dentures with palatal rugae was significantly less 12.16 (95% confidence interval: 6.81 to 17.50, P<.001). The differences in the OHIP-EDENT total scores were not significantly different -1.75 (95% confidence interval: -3.7 to 0.23, P=.082). Differences in each item ratings were also found to be not significantly different (P>.05), except for the frequency of mealtime interruption (P=.041), which was reported to increase when rugae had been provided.
CONCLUSIONS


Complete dentures with palatal rugae were not perceived to improve patient satisfaction or oral health-related quality of life. However, they were perceived to be more difficult to clean and to increase frequency of interruptions during eating.",2021,No significant differences were found between ratings for the 2 palatal contours in terms of general satisfaction 2.32,"['Fifty participants', 'Edentulous patients aged 45 to 80 years, with no relevant medical conditions, seeking complete dentures at a university hospital between May and July 2019 were recruited', 'edentulous patients and their oral health impact profile when provided with complete dentures with palatal rugae compared with a polished palate']",['palatal rugae to complete dentures'],"['patient satisfaction or oral health-related quality of life', 'satisfaction with ease of cleaning dentures with palatal rugae', 'patient satisfaction and oral health-related quality of life', '100-mm visual analog scale (primary outcome) and to rate their satisfaction regarding eating, taste perception, speaking, phonetics, and ease of cleaning', 'taste perception 0.57', 'OHIP-EDENT total scores']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}]","[{'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600133', 'cui_str': 'Does clean own dentures'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0031579', 'cui_str': 'Phonetics'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.212375,No significant differences were found between ratings for the 2 palatal contours in terms of general satisfaction 2.32,"[{'ForeName': 'Motasum', 'Initials': 'M', 'LastName': 'Abu-Awwad', 'Affiliation': 'Assistant Professor, Prosthodontic Department, University of Jordan School of Dentistry, Amman, Jordan. Electronic address: motasum@gmail.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Ereifej', 'Affiliation': 'Associate Professor, Prosthodontic Department, University of Jordan School of Dentistry, Amman, Jordan.'}, {'ForeName': 'Mais', 'Initials': 'M', 'LastName': 'Al-Hattab', 'Affiliation': 'General Dental Practitioner and Private practice, Amman, Jordan.'}, {'ForeName': 'Dima Abu', 'Initials': 'DA', 'LastName': 'Baker', 'Affiliation': 'Research Assistant, Prosthodontic Department, University of Jordan School of Dentistry, Amman, Jordan.'}, {'ForeName': 'Haralampos', 'Initials': 'H', 'LastName': 'Petridis', 'Affiliation': 'Professor and Chair, Prosthodontics Unit, University College London Eastman Dental Institute, London, United Kingdom.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.09.002']
345,33063570,Implementing a Novel Workplace Smoking Cessation Intervention Targeting Hispanic/Latino Construction Workers: A Pilot Cluster Randomized Trial.,"BACKGROUND


U.S. Hispanic/Latino construction workers constitute a large and historically underserved group in terms of smoking cessation services. Using formative research, we developed a worksite smoking cessation intervention tailored to the life/work circumstances of these workers.
AIMS


This study aims to examine the feasibility, acceptability, and potential efficacy of the developed intervention ""Enhanced Care"" (EC; one group behavioral counseling session provided around the food truck + fax referral to tobacco quitline [QL] + 8-week nicotine replacement treatment [NRT]) compared with ""Standard Care"" (SC; fax referral to tobacco QL + 8-week NRT) in a pilot, two-arm, cluster randomized controlled trial.
METHOD


In collaboration with construction site safety managers, a sample of 17 construction sites (EC: nine sites/65 smokers; SC: eight sites/69 smokers) was enrolled. Participants received two follow-ups at 3 and 6 months after enrollment. Feasibility outcomes were enrollment rate, adherence to treatment, and 6-month retention rates. The primary efficacy outcome was 6 months prolonged abstinence verified by expired carbon monoxide <10 ppm.
RESULTS


Enrollment rate was high (85.9%). Six-month follow-up rates were acceptable (EC = 76.9%, SC = 66.6%). Adherence to treatment was better in the EC group (received worksite intervention: EC = 93.8%, SC = 88.4%; contacted by QL: EC = 49.2%, SC = 40.6%). Abstinence rates were 27.7% for the EC and 20.3% for the SC ( p  = .315).
DISCUSSION


The developed intervention was feasible and acceptable, and it substantially improved abstinence among Hispanic/Latino workers. The involvement of safety managers was essential to the implementation of the intervention. Training safety managers to deliver the intervention has great potential to implement a sustainable smoking cessation service in the construction sector.",2021,"Abstinence rates were 27.7% for the EC and 20.3% for the SC ( p  = .315).
","['Targeting Hispanic/Latino Construction Workers', '17 construction sites (EC: nine sites/65 smokers; SC: eight sites/69 smokers) was enrolled']","['Standard Care"" (SC; fax referral to tobacco QL + 8-week NRT', 'worksite intervention: EC', 'intervention ""Enhanced Care"" (EC', 'tobacco quitline [QL] + 8-week nicotine replacement treatment [NRT', 'worksite smoking cessation intervention', 'Novel Workplace Smoking Cessation Intervention']","['enrollment rate, adherence to treatment, and 6-month retention rates', 'prolonged abstinence verified by expired carbon monoxide <10 ppm', 'Abstinence rates']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}, {'cui': 'C0337062', 'cui_str': 'Construction site'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085205', 'cui_str': 'Fax'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439187', 'cui_str': 'ppm'}]",,0.057977,"Abstinence rates were 27.7% for the EC and 20.3% for the SC ( p  = .315).
","[{'ForeName': 'Taghrid', 'Initials': 'T', 'LastName': 'Asfar', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Kristopher L', 'Initials': 'KL', 'LastName': 'Arheart', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'McClure', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Estefania C', 'Initials': 'EC', 'LastName': 'Ruano-Herreria', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Noella A', 'Initials': 'NA', 'LastName': 'Dietz', 'Affiliation': 'Broward Health Systems, Fort Lauderdale, FL, USA.'}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Ward', 'Affiliation': 'School of Public Health, The University of Memphis, Memphis, TN, USA.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Caban-Martinez', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Samano Martin Del Campo', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198120960395']
346,33278743,Using Artificial Intelligence to Predict Change in Depression and Anxiety Symptoms in a Digital Intervention: Evidence from a Transdiagnostic Randomized Controlled Trial.,"While digital psychiatric interventions reduce treatment barriers, not all persons benefit from this type of treatment. Research is needed to preemptively identify who is likely to benefit from these digital treatments in order to redirect those people to a higher level of care. The current manuscript used an ensemble of machine learning methods to predict changes in major depressive and generalized anxiety disorder symptoms from pre to 9-month follow-up in a randomized controlled trial of a transdiagnostic digital intervention based on participants' (N=632) pre-treatment data. The results suggested that baseline characteristics could accurately predict changes in depressive symptoms in both treatment groups (r=0.482, 95% CI[0.394, 0.561]; r=0.477, 95% CI[0.385, 0.560]) and anxiety symptoms in both treatment groups (r=0.569, 95% CI[0.491, 0.638]; r=0.548, 95% CI[0.464, 0.622]). These results suggest that machine learning models are capable of preemptively predicting a person's responsiveness to digital treatments, which would enable personalized decision-making about which persons should be directed towards standalone digital interventions or towards blended stepped-care.",2021,"The results suggested that baseline characteristics could accurately predict changes in depressive symptoms in both treatment groups (r=0.482, 95% CI[0.394, 0.561]; r=0.477, 95% CI[0.385, 0.560]) and anxiety symptoms in both treatment groups (r=0.569, 95% CI[0.491, 0.638]; r=0.548, 95% CI[0.464, 0.622]).",[],"['machine learning methods', 'transdiagnostic digital intervention']","['major depressive and generalized anxiety disorder symptoms', 'depressive symptoms', 'Depression and Anxiety Symptoms', 'anxiety symptoms']",[],"[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0851406', 'cui_str': 'Anxiety disorders and symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.203508,"The results suggested that baseline characteristics could accurately predict changes in depressive symptoms in both treatment groups (r=0.482, 95% CI[0.394, 0.561]; r=0.477, 95% CI[0.385, 0.560]) and anxiety symptoms in both treatment groups (r=0.569, 95% CI[0.491, 0.638]; r=0.548, 95% CI[0.464, 0.622]).","[{'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Jacobson', 'Affiliation': 'Dartmouth College. Electronic address: Nicholas.C.Jacobson@dartmouth.edu.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Nemesure', 'Affiliation': 'Dartmouth College.'}]",Psychiatry research,['10.1016/j.psychres.2020.113618']
347,33284144,Feasibility of an Intervention Study to Support Families When Their Loved One Has Life-sustaining Therapy Withdrawn.,"This investigation addressed family member perceptions of preparation for withdrawal of life-sustaining treatment in the intensive care unit. These families are at a high risk for psychosocial and physical sequelae. The quantitative results of this mixed methods study are reported. A control group received usual care and an educational booklet component of the intervention. The experimental group received the above plus exposure to comfort cart items and additional psychological support. Twenty-eight family members enrolled over a 13-month period. Sixty-one percent (10 intervention, 7 control) completed the follow-up. Fourteen family members (82%) recalled the booklet. Some family members reported moderate to severe depression (12.5%), anxiety (12.5%), and stress (12.6%). Satisfaction with care (83.7%-85.2%) and family member well-being (44.1) were within the norm. Short Form-36 physical component score was higher than the norm, and the mental component score was lower than the norm. This study demonstrated feasibility and acceptability of the interventions and follow-up questionnaires when families make the difficult decision to withdraw treatment. Strategies are suggested to strengthen statistical power.",2021,This study demonstrated feasibility and acceptability of the interventions and follow-up questionnaires when families make the difficult decision to withdraw treatment.,"['Twenty-eight family members enrolled over a 13-month period', 'Support Families']","['usual care and an educational booklet component of the intervention', 'above plus exposure to comfort cart items and additional psychological support']","['severe depression', 'Short Form-36 physical component score', 'anxiety', 'mental component score']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150232', 'cui_str': 'Family support'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0179636', 'cui_str': 'Cart'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}]","[{'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0174313,This study demonstrated feasibility and acceptability of the interventions and follow-up questionnaires when families make the difficult decision to withdraw treatment.,"[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Scharf', 'Affiliation': ''}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tomlin', 'Affiliation': ''}, {'ForeName': 'Jooyoung', 'Initials': 'J', 'LastName': 'Cheon', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mooney-Doyle', 'Affiliation': ''}, {'ForeName': 'Judith Gedney', 'Initials': 'JG', 'LastName': 'Baggs', 'Affiliation': ''}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Weigand', 'Affiliation': ''}]",Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association,['10.1097/NJH.0000000000000717']
348,33027722,Hysteroscopic versus cervical injection for sentinel node detection in endometrial cancer: A multicenter prospective randomised controlled trial from the Multicenter Italian Trials in Ovarian cancer (MITO) study group.,"AIM


During the last years, the role of sentinel lymph node mapping (SLNM) for endometrial cancer (EC) surgical treatment has increased in popularity. However, several controversies remain about different technical steps of SLNM. Thus, a randomised control trial was designed to compare cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection for SLNM of newly diagnosed EC undergoing surgical staging. The primary end-point of the study was to compare these two techniques in terms of para-aortic detection rate.
METHODS


Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study. This randomised trial distinguished patients in two study groups according to two different techniques of ICG SLNM: CI versus HI injection. Patients who met the inclusion criteria were randomly assigned to CI or HI injection in a 1:1 ratio. The central randomisation system allocated patient randomisation numbers sequentially in the order in which the patients were enrolled. This randomised trial was not blinded for either patients or the surgeons.
RESULTS


From March 2017 until April 2019, a total of 165 patients were randomised in this study: 85 (51.5%) in the CI group and 80 (48.5%) in the HI group. After randomisation, 14 (8.5%) patients were excluded from the study. Finally, 151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group. Hysteroscopy injection shows an ability to detect Sentinel nodes (SNLs) in the para-aortic area of about 10% greater compared with CI injection, although this difference did not reach statistical significance. The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%). The CI injection was correlated with higher SLN detection rates at the pelvic level compared with HI injection. Pelvic and overall detection was higher in the CI group.
CONCLUSIONS


The present study supports the adoption of CI instead of HI injection because the former allows better identification of sentinel nodes (especially in the pelvic area). Detection of SLN in the para-aortic area was slightly higher in patients receiving a HI injection, but the difference with the CI route was not statistically significant.",2020,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"['151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group', '165 patients', 'Patients who met the inclusion criteria', 'patients or the surgeons', 'From March 2017 until April 2019', 'Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study', 'endometrial cancer', 'newly diagnosed EC undergoing surgical staging']","['cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection', 'sentinel lymph node mapping (SLNM', 'Hysteroscopic versus cervical injection', 'ICG\xa0SLNM: CI versus HI injection', 'CI or HI injection', 'Hysteroscopy injection']","['para-aortic detection rate', 'SLN detection rates', 'Pelvic and overall detection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443276', 'cui_str': 'Pathological staging'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1519247', 'cui_str': 'Sentinel lymph node mapping'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",165.0,0.181524,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Ditto', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy. Electronic address: antonino.ditto@istitutotumori.mi.it.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Casarin', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Pinelli', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Perrone', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Scollo', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Martinelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Bogani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Leone Roberti Maggiore', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Signorelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiappa', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giorda', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS CRO Oncologic Institute of Aviano, Aviano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Scibilia', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Pierandrea', 'Initials': 'P', 'LastName': 'De Iaco', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Mariateresa', 'Initials': 'M', 'LastName': 'Evangelista', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ghezzi', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Paolini', 'Affiliation': 'Department of Pathology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Lo Vullo', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Montone', 'Affiliation': 'Clinical Study Coordinator, Ufficio Operativo per la Ricerca Clinica - Clinical Trial Center Fondazione IRCCS Istituto Nazionale dei Tumori, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.030']
349,33032908,Alpha-lipoic acid improves sperm motility in infertile men after varicocelectomy: a triple-blind randomized controlled trial.,"RESEARCH QUESTION


Does supplementation with alpha-lipoic acid (ALA) enhance sperm parameters and/or the status of sperm lipid peroxidation and DNA fragmentation in men who have undergone microsurgical repair of a varicocele?
DESIGN


Individuals with a varicocele who had undergone varicocelectomy were divided into two groups receiving either 600 mg of ALA or an identical placebo for 80 days. Semen samples obtained from the participants before surgery and after completion of the course of medication were analysed and compared. Participants, clinicians and data analysts were blinded to the randomization sequence.
RESULTS


In the ALA group, total motility (P = 0.01) and progressive motility (P = 0.002) of the spermatozoa were significantly higher compared with the placebo group after surgery. Sperm lipid peroxidation and DNA damage (assessed by sperm chromatin structure assay) showed significant decreases in both the ALA and placebo groups (P ≤ 0.02) after treatment.
CONCLUSIONS


An 80-day course of ALA medication after surgical repair improves total motility and progressive motility of the spermatozoa in individuals with a varicocele.",2020,"Sperm lipid peroxidation and DNA damage (assessed by sperm chromatin structure assay) showed significant decreases in both the ALA and placebo groups (P ≤ 0.02) after treatment.
","['individuals with a varicocele', 'Individuals with a varicocele who had undergone varicocelectomy', 'men who have undergone microsurgical repair of a varicocele', 'infertile men after varicocelectomy']","['placebo', 'alpha-lipoic acid (ALA', '600\xa0mg of ALA or an identical placebo', 'Alpha-lipoic acid']","['total motility and progressive motility', 'progressive motility', 'Sperm lipid peroxidation and DNA damage', 'sperm motility', 'total motility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0194985', 'cui_str': 'Excision of varicocele'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0567345', 'cui_str': 'Microsurgical repair'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}]",,0.50103,"Sperm lipid peroxidation and DNA damage (assessed by sperm chromatin structure assay) showed significant decreases in both the ALA and placebo groups (P ≤ 0.02) after treatment.
","[{'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Abbasi', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran; Isfahan Fertility and Infertility Center, Isfahan, Iran.'}, {'ForeName': 'Newsha', 'Initials': 'N', 'LastName': 'Molavi', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran.'}, {'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Tavalaee', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran.'}, {'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Abbasi', 'Affiliation': 'Isfahan Fertility and Infertility Center, Isfahan, Iran.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Nasr-Esfahani', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran; Isfahan Fertility and Infertility Center, Isfahan, Iran. Electronic address: mh.nasr-esfahani@royaninstitute.org.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.08.013']
350,33044490,"Swab-Yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 2. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Rectal, Pharyngeal, and Urogenital Samples Analyzed Individually, Versus as a Pooled Specimen, for the Diagnosis of Gonorrhea and Chlamydia.","BACKGROUND


Sexual history does not accurately identify those with extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), so universal extragenital sampling is recommended. Nucleic acid amplification tests (NAATs) are expensive. If urogenital, plus rectal and pharyngeal, samples are analyzed, the diagnostic cost is trebled. Pooling samples into 1 NAAT container would cost the same as urogenital samples alone. We compared clinician triple samples analyzed individually with self-taken pooled samples for diagnostic accuracy, and cost, in men who have sex with men (MSM) and females.
METHODS


This was a prospective, convenience sample in United Kingdom sexual health clinic. Randomized order of clinician and self-samples from pharynx, rectum, plus first-catch urine (FCU) in MSM and vulvovaginal swabs (VVS) in females, for NG and CT detection.
RESULTS


Of 1793 participants (1284 females, 509 MSM), 116 had NG detected (75 urogenital, 83 rectum, 72 pharynx); 276 had CT detected (217 urogenital, 249 rectum, 63 pharynx). There was no difference in sensitivities between clinician triple samples and self-pooled specimens for NG (99.1% and 98.3%), but clinician samples analyzed individually identified 3% more chlamydia infections than pooled (99.3% and 96.0%; P = .027). However, pooled specimens identified more infections than VVS/FCU alone. Pooled specimens missed 2 NG and 11 CT infections, whereas VVS/FCU missed 41 NG and 58 CT infections. Self-taken pooled specimens were the most cost-effective.
CONCLUSIONS


FCU/VVS testing alone missed many infections. Self-taken pooled samples were as sensitive as clinician triple samples for identifying NG, but clinician samples analyzed individually identified 3% more CT infections than pooled. The extragenital sampling was achievable at no additional diagnostic cost to the FCU/VVS.
CLINICAL TRIALS REGISTRATION


NCT02371109.",2021,"276 had CT detected (217 urogenital, 249 rectum, 63 pharynx).There was no difference in sensitivities between clinician triple samples and self-pooled specimens for NG (99.1%, 98.3%) but clinician samples analysed individually identified 3% more chlamydia infections than pooled (99.3%, 96.0%; p=0.027).","['Prospective, convenience, sample in UK sexual health clinic', '1793 participants (1284 females, 509 MSM']",[],['chlamydia infections'],"[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}]",[],"[{'cui': 'C0008149', 'cui_str': 'Chlamydial infection'}]",1793.0,0.0231615,"276 had CT detected (217 urogenital, 249 rectum, 63 pharynx).There was no difference in sensitivities between clinician triple samples and self-pooled specimens for NG (99.1%, 98.3%) but clinician samples analysed individually identified 3% more chlamydia infections than pooled (99.3%, 96.0%; p=0.027).","[{'ForeName': 'Janet D', 'Initials': 'JD', 'LastName': 'Wilson', 'Affiliation': 'Leeds Sexual Health, Leeds Teaching Hospitals National Health Services Trust, Leeds, United Kingdom.'}, {'ForeName': 'Harriet E', 'Initials': 'HE', 'LastName': 'Wallace', 'Affiliation': 'Leeds Sexual Health, Leeds Teaching Hospitals National Health Services Trust, Leeds, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Loftus-Keeling', 'Affiliation': 'Leeds Sexual Health, Leeds Teaching Hospitals National Health Services Trust, Leeds, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ward', 'Affiliation': 'Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Davies', 'Affiliation': 'Department of Epidemiology and Biostatistics, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Vargas-Palacios', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Department of Clinical Microbiology, Leeds Teaching Hospitals National Health Services Trust, Leeds, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1546']
351,33054556,Augmenting Frontal Dopamine Tone Enhances Maintenance over Gating Processes in Working Memory.,"The contents of working memory must be maintained in the face of distraction, but updated when appropriate. To manage these competing demands of stability and flexibility, maintained representations in working memory are complemented by distinct gating mechanisms that selectively transmit information into and out of memory stores. The operations of such dopamine-dependent gating systems in the midbrain and striatum and their complementary dopamine-dependent memory maintenance operations in the cortex may therefore be dissociable. If true, selective increases in cortical dopamine tone should preferentially enhance maintenance over gating mechanisms. To test this hypothesis, tolcapone, a catechol-O-methyltransferase inhibitor that preferentially increases cortical dopamine tone, was administered in a randomized, double-blind, placebo-controlled, within-subject fashion to 49 participants who completed a hierarchical working memory task that varied maintenance and gating demands. Tolcapone improved performance in a condition with higher maintenance requirements and reduced gating demands, reflected in a reduction in the slope of RTs across the distribution. Resting-state fMRI data demonstrated that the degree to which tolcapone improved performance in individual participants correlated with increased connectivity between a region important for stimulus response mappings (left dorsal premotor cortex) and cortical areas implicated in visual working memory, including the intraparietal sulcus and fusiform gyrus. Together, these results provide evidence that augmenting cortical dopamine tone preferentially improves working memory maintenance.",2021,"Tolcapone improved performance in a condition with higher maintenance requirements and reduced gating demands, reflected in a reduction in the slope of RTs across the distribution.",['49 participants who completed a hierarchical working memory task that varied maintenance and gating demands'],"['placebo', 'Tolcapone']",['working memory maintenance'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",49.0,0.073384,"Tolcapone improved performance in a condition with higher maintenance requirements and reduced gating demands, reflected in a reduction in the slope of RTs across the distribution.","[{'ForeName': 'Daniella J', 'Initials': 'DJ', 'LastName': 'Furman', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Chatham', 'Affiliation': 'F. Hoffman-La Roche AG, Basel Switzerland.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Good', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Badre', 'Affiliation': 'Brown University.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hsu', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Kayser', 'Affiliation': 'University of California, San Francisco.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01641']
352,33293204,The Effect of Glycemic Control on Renal Triglyceride Content Assessed by Proton Spectroscopy in Patients With Type 2 Diabetes Mellitus: A Single-Center Parallel-Group Trial.,"OBJECTIVE


Ectopic lipid accumulation in the kidney (fatty kidney) is a potential driver of diabetic kidney disease, and tight glycemic control can reduce risk of diabetic nephropathy. We assessed whether glycemic control influences renal triglyceride content (RTGC). Furthermore, we compared glucagon-like peptide-1 receptor agonist liraglutide versus standard glucose-lowering therapy.
DESIGN AND METHODS


In this single-center parallel-group trial, patients with type 2 diabetes mellitus were randomized to liraglutide or placebo added to standard care (metformin/sulfonylurea derivative/insulin). Changes in RTGC after 26 weeks of glycemic control measured by proton spectroscopy and difference in RTGC between treatment groups were analyzed.
RESULTS


Fifty patients with type 2 diabetes mellitus were included in the baseline analysis (mean age, 56.5 ± 9.1 years; range, 33-73 years; 46% males). Seventeen patients had baseline and follow-up measurements. Mean glycated hemoglobin was 7.8 ± 0.8%, which changed to 7.3 ± 0.9% after 26 weeks of glycemic control irrespective of treatment group (P = .046). Log-transformed RTGC was -0.68 ± 0.30% and changed to -0.83 ± 0.32% after 26 weeks of glycemic control irrespective of treatment group (P = .049). A 26-week-to-̶baseline RTGC ratio (95% confidence interval) was significantly different between liraglutide (-0.30 [-0.50, -0.09]) and placebo added to standard care (-0.003 [-0.34, 0.34]) (P = .04).
CONCLUSION


In this exploratory study, we found that 26 weeks of glycemic control resulted in lower RTGC, in particular for liraglutide; however, larger clinical studies are needed to assess whether these changes reflect a true effect of glycemic control on fatty kidney.",2021,"A 26-week-to-̶baseline RTGC ratio (95% confidence interval) was significantly different between liraglutide (-0.30 [-0.50, -0.09]) and placebo added to standard care (-0.003 [-0.34, 0.34])","['Fifty patients with type 2 diabetes mellitus', '9.1\xa0years; range, 33-73\xa0years; 46% males', 'Patients', 'Seventeen patients had baseline and follow-up measurements', 'patients with type 2 diabetes mellitus', 'With Type 2 Diabetes Mellitus']","['liraglutide or placebo added to standard care (metformin/sulfonylurea derivative/insulin', 'liraglutide', 'placebo', 'glucagon-like peptide-1 receptor agonist liraglutide', 'Glycemic Control']","['Mean glycated hemoglobin', 'glycemic control influences renal triglyceride content (RTGC', 'Renal Triglyceride Content']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",50.0,0.100143,"A 26-week-to-̶baseline RTGC ratio (95% confidence interval) was significantly different between liraglutide (-0.30 [-0.50, -0.09]) and placebo added to standard care (-0.003 [-0.34, 0.34])","[{'ForeName': 'Ilona A', 'Initials': 'IA', 'LastName': 'Dekkers', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: i.a.dekkers@lumc.nl.'}, {'ForeName': 'Maurice B', 'Initials': 'MB', 'LastName': 'Bizino', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands; Division of Endocrinology, Department of Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Elisabeth H M', 'Initials': 'EHM', 'LastName': 'Paiman', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Johannes W', 'Initials': 'JW', 'LastName': 'Smit', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Jazet', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Aiko P J', 'Initials': 'APJ', 'LastName': 'de Vries', 'Affiliation': 'Division of Nephrology and Transplant Medicine, Department of Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hildo J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2020.09.006']
353,33028623,Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850).,"OBJECTIVE


To investigate whether neoadjuvant chemotherapy followed by interval debulking surgery is superior to primary debulking surgery in terms of perioperative complications and progression-free survival, in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load.
METHODS


Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy. Patients with high tumor load assessed by a standardized laparoscopic predictive index were randomly assigned (1:1 ratio) to undergo either primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B). Co-primary outcome measures were progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life. Survival analyses were performed on an intention-to-treat population.
RESULTS


171 patients were randomly assigned to primary debulking surgery (n=84) versus neoadjuvant chemotherapy (n=87). Rates of complete resection (R0) were different between the arms (47.6% in arm A vs 77.0% in arm B; p=0.001). 53 major postoperative complications were registered, mainly distributed in arm A compared with arm B (25.9% vs 7.6%; p=0.0001). All patients were included in the intent-to-treat analysis. With an overall median follow-up of 59 months (95% CI 53 to 64), 142 (83.0%) disease progressions/recurrences and 103 deaths (60.2%) occurred. Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
CONCLUSIONS


Neoadjuvant chemotherapy and primary debulking surgery have the same efficacy when used at their maximal possibilities, but the toxicity profile is different.",2020,"Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
","['Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy', '171 patients', 'advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load', 'Patients with high tumor load assessed by a standardized laparoscopic predictive index']","['primary debulking surgery', 'primary debulking surgery versus neoadjuvant chemotherapy', 'primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B', 'neoadjuvant chemotherapy followed by interval debulking surgery', 'neoadjuvant chemotherapy']","['progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life', 'Median progression-free and overall survival', 'disease progressions/recurrences and 103 deaths', 'toxicity profile', 'advanced epithelial ovarian cancer', '53 major postoperative complications', 'Rates of complete resection (R0']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}]",171.0,0.400373,"Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fagotti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy annafagotti70@gmail.com.'}, {'ForeName': 'Maria Gabriella', 'Initials': 'MG', 'LastName': 'Ferrandina', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Vizzielli', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Pasciuto', 'Affiliation': 'Statistics Technology Archiving Research (STAR) Center, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fanfani', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Gallotta', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Pasquale Alessandro', 'Initials': 'PA', 'LastName': 'Margariti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Chiantera', 'Affiliation': 'Department of Gynecologic Oncology, ARNAS Civico Di Cristina Benfratelli, Palermo, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Costantini', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Gueli Alletti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': 'Gynecologic Oncology, Gemelli Molise spa, Università Cattolica del Sacro Cuore, Campobasso, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001640']
354,33039321,Promoting fertility awareness and preconception health using a chatbot: a randomized controlled trial.,"RESEARCH QUESTION


What are the effects of using a fertility education chatbot, i.e. automatic conversation programme, on knowledge, intentions to improve preconception behaviour and anxiety?
DESIGN


A three-armed, randomized controlled trial was conducted using an online social research panel. Participants included 927 women aged 20-34 years who were randomly allocated to one of three groups: a fertility education chatbot (intervention group), a document about fertility and preconception health (control group 1) or a document about an irrelevant topic (control group 2). Participants' scores on the Cardiff Fertility Knowledge Scale and the State-Trait Anxiety Inventory, their intentions to optimize preconception behaviours, e.g. taking folic acid, and the free-text feedback provided by chatbot users were assessed.
RESULTS


A repeated-measures analysis of variance showed significant fertility knowledge gains after the intervention in the intervention group (+9.1 points) and control group 1 (+14.9 points) but no significant change in control group 2 (+1.1 points). Post-test increases in the intentions to optimize behaviours were significantly higher in the intervention group than in control group 2, and were similar to those in control group 1. Post-test state anxiety scores were significantly lower in the intervention group than in control group 1 and control group 2. User feedbacks about the chatbot suggested technical limitations, e.g. low comprehension of users' words, and pros and cons of using the chatbot, e.g. convenient versus coldness.
CONCLUSIONS


Providing fertility education using a chatbot improved fertility knowledge and intentions to optimize preconception behaviour without increasing anxiety, but the improvement in knowledge was small. Further technical development and exploration of personal affinity for technology is required.",2020,"CONCLUSIONS


Providing fertility education using a chatbot improved fertility knowledge and intentions to optimize preconception behaviour without increasing anxiety, but the improvement in knowledge was small.",['Participants included 927 women aged 20-34 years'],"['fertility education chatbot (intervention group), a document about fertility and preconception health (control group 1) or a document about an irrelevant topic (control group 2']","['intentions to optimize behaviours', 'Cardiff Fertility Knowledge Scale and the State-Trait Anxiety Inventory, their intentions to optimize preconception behaviours, e.g. taking folic acid, and the free-text feedback provided by chatbot users', 'fertility knowledge gains', 'Post-test state anxiety scores']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1689849', 'cui_str': 'Fertility education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",927.0,0.0421775,"CONCLUSIONS


Providing fertility education using a chatbot improved fertility knowledge and intentions to optimize preconception behaviour without increasing anxiety, but the improvement in knowledge was small.","[{'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Maeda', 'Affiliation': 'Department of Environmental Health Science and Public Health, Akita University Graduate School of Medicine, Akita 010-8543, Japan. Electronic address: erimaeda@med.akita-u.ac.jp.'}, {'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Miyata', 'Affiliation': 'Reproduction Center, Dokkyo Medical University, Saitama 343-8555, Japan.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Boivin', 'Affiliation': 'Cardiff Fertility Studies Research Group, School of Psychology, Cardiff University, Cardiff CF10 3AT, UK.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Environmental Health Science and Public Health, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}, {'ForeName': 'Yukiyo', 'Initials': 'Y', 'LastName': 'Kumazawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Shirasawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': ""Umegaoka Women's Clinic, Tokyo 154-0022, Japan.""}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Terada', 'Affiliation': 'Department of Obstetrics and Gynecology, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.09.006']
355,33287685,Effects of brief acceptance and commitment therapy (ACT) on subjective cognitive impairment in breast cancer patients undergoing chemotherapy.,"PURPOSE


This study examined the efficacy of a brief acceptance and commitment therapy (ACT) on subjective cognitive impairment in breast cancer patients undergoing chemotherapy.
METHODS


Data collection was carried out in 3-time points: baseline (T1), screening (T2), and post-treatment (T3). Respondents who had significant subjective cognitive impairment were randomly divided into two groups: intervention (n = 30) and waitlist (n = 30). Respondents in the intervention group received 4 sessions of 1 hour of ACT therapy.
FINDINGS


Respondents in the intervention group showed significant improvement in subjective cognitive impairment, depression, anxiety, and psychological inflexibility after the ACT intervention ( p  < 0.05). After controlling the covariates, group differences in all variables were significant except for fatigue and psychological inflexibility has the highest effect size ( d  = 4.69).
CONCLUSION


ACT could be considered as an effective intervention to ameliorate subjective cognitive impairment, anxiety, depression, and psychological inflexibility in breast cancer patients undergoing chemotherapy.
IMPLICATIONS FOR PSYCHOSOCIAL PROVIDERS


This study highlights the importance of screening for subjective cognitive impairment in breast cancer patients undergoing chemotherapy and heightens their opportunity to receive proper management as earlier as possible.",2021,"FINDINGS


Respondents in the intervention group showed significant improvement in subjective cognitive impairment, depression, anxiety, and psychological inflexibility after the ACT intervention ( p  < 0.05).","['breast cancer patients undergoing chemotherapy', 'breast cancer patients undergoing', 'Respondents who had significant subjective cognitive impairment']","['ACT therapy', 'chemotherapy', 'brief acceptance and commitment therapy (ACT']","['subjective cognitive impairment, depression, anxiety, and psychological inflexibility', 'fatigue and psychological inflexibility', 'subjective cognitive impairment', 'subjective cognitive impairment, anxiety, depression, and psychological inflexibility']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0205073,"FINDINGS


Respondents in the intervention group showed significant improvement in subjective cognitive impairment, depression, anxiety, and psychological inflexibility after the ACT intervention ( p  < 0.05).","[{'ForeName': 'Nurul Izzah', 'Initials': 'NI', 'LastName': 'Shari', 'Affiliation': 'Faculty of Medicine, Department of Psychological Medicine, University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nor Zuraida', 'Initials': 'NZ', 'LastName': 'Zainal', 'Affiliation': 'Faculty of Medicine, Department of Psychological Medicine, University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chong Guan', 'Initials': 'CG', 'LastName': 'Ng', 'Affiliation': 'Faculty of Medicine, Department of Psychological Medicine, University Malaya, Kuala Lumpur, Malaysia.'}]",Journal of psychosocial oncology,['10.1080/07347332.2020.1856283']
356,33293157,Analgesic efficacy of sufentanil in dressings after surgical treatment of burn wounds.,"BACKGROUND


The aim of this study was to assess the analgesic efficacy of sufentanil in dressings after surgical treatment of burn wounds.
PATIENTS AND METHODS


Twenty adult patients, who underwent surgical treatment of third-degree burn wounds under general anesthesia, were included. Two of the patients underwent surgery twice. During surgery, patients received 50-100 μg fentanyl every 20-30 min and, after surgery, patients received 100 mg ketoprofen twice daily. Additionally, ten patients (group 1) received 50 μg sufentanil added to the burn wound dressings soaked in octenidine and phenoxyethanol while 10 patients (group 2) received 25 μg sufentanil added to the same dressings. The rescue analgesic, which was administered when pain intensified, was 5 mg subcutaneous morphine. Plasma sufentanil concentrations were assayed at 1, 2, 3, and 6 h after surgery completion and when pain was reported, along with pain intensity evaluation.
RESULTS


Sufentanil was not detected in the serum of any patients. Rescue morphine was given during the postoperative period (24 h) in one patient in group 1 (who underwent surgery twice) and three patients in group 2. The mean sufentanil concentration in dressings was higher in group 1 (0.13 ± 0.03) than group 2 (0.06 ± 0.03 μg/mL; p < 0.001). The group 1 patient who received rescue morphine had a sufentanil concentration of 0.10 μg/mL, which was the lowest concentration in group 1. Group 2 patients who received rescue morphine had sufentanil concentrations of at least two-fold lower (0.03-0.05 μg/mL). No adverse effects were observed.
CONCLUSIONS


Sufentanil in dressings after burn wound surgery provides effective and safe analgesia and the sufentanil concentration in dressings should be ≥0.10 μg/mL in a solution of octenidine and phenoxyethanol.",2021,The mean sufentanil concentration in dressings was higher in group 1 (0.13 ± 0.03) than group 2 (0.06 ± 0.03 μg/mL; p < 0.001).,"['Twenty adult patients, who underwent surgical treatment of third-degree burn wounds under general anesthesia, were included', 'burn wounds']","['morphine', 'ketoprofen', 'Sufentanil', 'sufentanil', 'Rescue morphine', '25 μg sufentanil', '50 μg sufentanil added to the burn wound dressings soaked in octenidine and phenoxyethanol']","['sufentanil concentrations', 'analgesic efficacy', 'Plasma sufentanil concentrations', 'Analgesic efficacy', 'mean sufentanil concentration in dressings', 'adverse effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0433445', 'cui_str': 'Third degree burn injury'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0069351', 'cui_str': 'octenidine'}, {'cui': 'C0301042', 'cui_str': 'Phenoxyethanol'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",20.0,0.184272,The mean sufentanil concentration in dressings was higher in group 1 (0.13 ± 0.03) than group 2 (0.06 ± 0.03 μg/mL; p < 0.001).,"[{'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Kowalski', 'Affiliation': 'Department of Palliative Medicine, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Zawadzki', 'Affiliation': 'Department of Forensic Medicine, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Leppert', 'Affiliation': 'Laboratory of Quality of Life Research, Poznan University of Medical Sciences, Poznan, Poland. Electronic address: wojciechleppert@wp.pl.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Szpot', 'Affiliation': 'Department of Forensic Medicine, Wroclaw Medical University, Wroclaw, Poland; Institute of Forensic Toxicology, Borowa, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Siczek', 'Affiliation': 'Department of Forensic Medicine, Wroclaw Medical University, Wroclaw, Poland; Institute of Forensic Toxicology, Borowa, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Słowiński', 'Affiliation': 'Department of Trauma, Burns and Plastic Surgery, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Sobieszczańska', 'Affiliation': 'Department and Clinic of Geriatrics, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Gawłowska', 'Affiliation': 'Department of Anesthesiology, Jozef Strus Multiprofile Municipal Hospital, Poznan, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wieczorowska-Tobis', 'Affiliation': 'Department of Palliative Medicine, Poznan University of Medical Sciences, Poznan, Poland.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.10.006']
357,33301040,An Examination of Chronic Pain Indices and the Updated Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental-Disorders-Fifth Edition.,"INTRODUCTION


Chronic pain and post-traumatic stress disorder (PTSD) comorbidity is prevalent among veterans and is associated with increased levels of pain severity and pain-related disability. An improved understanding of the relationship between these co-occurring disorders, in addition to effective integrated treatments, will develop by considering the changes to the PTSD diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The current study examined the relationship between the revised PTSD Checklist for DSM-5 (PCL-5) symptom clusters (i.e., intrusion, avoidance, negative alterations in cognition and mood [NACM], and arousal) and chronic pain measurements (i.e., pain severity, interference, and disability).
MATERIALS AND METHODS


Participants included 103 veterans (ages 26-70, mean = 45.33) participating in a randomized clinical trial examining the efficacy of an interdisciplinary pain management program for chronic musculoskeletal pain. The study was approved by a university system Institutional Review Board and affiliated healthcare system.
RESULTS


The participants with a provisional PTSD diagnosis based on PCL-5 responses (N = 76) had significantly greater pain severity, interference, and disability than the participants without a provisional diagnosis (N = 23). Correlations between symptom clusters and pain measurements were mostly significant and positive with varying strengths. The avoidance symptom cluster, however, had relatively weaker correlations with pain measurements and was not significantly associated with the numeric rating scale of pain severity. Path analyses revealed that, after controlling for avoidance symptoms, significant associations remained between NACM and all the pain measurements. After controlling for NACM symptoms, however, there were no significant associations between avoidance symptoms and pain measurements.
CONCLUSION


The current study highlights a need to re-examine the leading theories about the mutual maintenance of these disorders in order to develop effective integrative treatment approaches. PTSD-related avoidance may have a relatively weaker role in co-occurring chronic pain than the other symptom clusters and may have a qualitatively different role than chronic pain-related avoidance. Future research should explore the relationship between the avoidance in PTSD and the avoidance in chronic pain as well as identify which chronic pain measurements are the most useful when examining the relationship between PTSD and chronic pain. The potential impact of trauma-related cognition and mood on chronic pain indicates that this is an important area for intervention and should be considered in the development of integrated treatments for chronic pain and PTSD among veterans.",2021,"The avoidance symptom cluster, however, had relatively weaker correlations with pain measurements and was not significantly associated with the numeric rating scale of pain severity.","['participants with a provisional PTSD diagnosis based on PCL-5 responses (N\u2009=\u200976', 'Participants included 103 veterans (ages 26-70, mean\u2009=\u200945.33) participating', 'chronic musculoskeletal pain']",['interdisciplinary pain management program'],"['NACM], and arousal) and chronic pain measurements (i.e., pain severity, interference, and disability', 'avoidance symptoms and pain measurements', 'revised PTSD Checklist for DSM-5 (PCL-5) symptom clusters (i.e., intrusion, avoidance, negative alterations in cognition and mood', 'pain severity, interference, and disability', 'pain measurements', 'numeric rating scale of pain severity']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0349812,"The avoidance symptom cluster, however, had relatively weaker correlations with pain measurements and was not significantly associated with the numeric rating scale of pain severity.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lehinger', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Reed', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nabity', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Brackins', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Villarreal', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'McGeary', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Tabatha', 'Initials': 'T', 'LastName': 'Blount', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Cobos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Jaramillo', 'Affiliation': 'Department of Veterans Affairs, South Texas Veterans Health Care System, San Antonio, TX 78229, USA.'}, {'ForeName': 'Blessen C', 'Initials': 'BC', 'LastName': 'Eapen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, VA Greater Los Angeles Health Care System, Los Angeles, CA 90073, USA.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Pugh', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Potter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Houle', 'Affiliation': 'Department of Anesthesia, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'McGeary', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}]",Military medicine,['10.1093/milmed/usaa529']
358,33054113,Intravenous iron preparations transiently generate non-transferrin-bound iron from two proposed pathways.,"Intravenous iron-carbohydrate complex preparations (IVIPs) are non-interchangeable pro-drugs: their pharmacokinetics (PK) varies determined by semi-crystalline iron core and carbohydrate shell structures, influences pharmacodynamics (PD) and thus efficacy and safety. Examining PK/PD relationships of 3 IVIPs we identify a two-pathway model of transient NTBI generation following single dose administration. 28 hypoferremic non-anemic patients randomized to 200mg iron as ferric carboxymaltose (Fe-carboxymaltose), iron sucrose (Fe-sucrose), iron isomaltoside 1000 (Fe-isomaltoside-1000), n=8/arm, or placebo, n=4, on a 2-week PK/PD study, had samples analysed for total serum iron, IVIP-iron, transferrin-bound iron (TBI) by HPLC-ICP-MS, transferrin saturation (TSAT), serum ferritin (s-Ferritin) by standard methods, non-TBI (NTBI) and hepcidin as published before. IVIP-dependent increases in these parameters returned to baseline in 48-150h, except for s-Ferritin and TSAT. NTBI was low with Fe-isomaltoside-1000 (0.13µM at 8h), rapidly increased with Fe-sucrose (0.8µM at 2h, 1.25µM at 4h), and delayed for Fe-carboxymaltose (0.57µM at 24h). NTBI AUCs were 7-fold greater for Fe-carboxymaltose and Fe-sucrose than for Fe-isomaltoside-1000. Hepcidin peak time varied, but not AUC or mean levels. s-Ferritin levels and AUC were highest for Fe-carboxymaltose and greater than placebo for all IVIPs. We propose 2 mechanisms for the observed NTBI kinetics: rapid and delayed NTBI appearance consistent with direct (circulating IVIP-to-plasma) and indirect (IVIP-to-macrophage-to-plasma) iron release based on IVIP plasma half-life and s-Ferritin dynamics. IVIPs generate different, broadly stability- and PK-dependent, NTBI and s-Ferritin signatures, which may influence iron bioavailability, efficacy and safety. Longer-term studies should link NTBI exposure to subsequent safety and efficacy parameters and potential clinical consequences.",2021,s-Ferritin levels and AUC were highest for Fe-carboxymaltose and greater than placebo for all IVIPs.,['28 hypoferremic non-anemic patients'],"['placebo', '200mg iron as ferric carboxymaltose (Fe-carboxymaltose), iron sucrose (Fe-sucrose), iron isomaltoside 1000 (Fe-isomaltoside-1000), n=8/arm, or placebo', 'Intravenous iron-carbohydrate complex preparations (IVIPs']","['NTBI AUCs', 'Hepcidin peak time', 'iron bioavailability, efficacy and safety', 'total serum iron, IVIP-iron, transferrin-bound iron (TBI) by HPLC-ICP-MS, transferrin saturation (TSAT), serum ferritin (s-Ferritin) by standard methods, non-TBI (NTBI) and hepcidin', 's-Ferritin levels and AUC', 'NTBI']","[{'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0060241', 'cui_str': 'iron sucrose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C2947549', 'cui_str': 'iron isomaltoside 1000'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0301498', 'cui_str': 'Iron carbohydrate complex'}]","[{'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0008562', 'cui_str': 'High pressure liquid chromatography'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",28.0,0.05506,s-Ferritin levels and AUC were highest for Fe-carboxymaltose and greater than placebo for all IVIPs.,"[{'ForeName': 'Maciej W', 'Initials': 'MW', 'LastName': 'Garbowski', 'Affiliation': ""University College London (UCL) Cancer Institute Haematology Department; King's College London (KCL) Institute of Pharmaceutical Science; London Metallomics Consortium. maciej.garbowski@ucl.ac.uk.""}, {'ForeName': 'Sukhvinder', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': ""King's College London (KCL) Institute of Pharmaceutical Science.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Porter', 'Affiliation': 'University College London (UCL) Cancer Institute Haematology Department.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Mori', 'Affiliation': 'Vifor Pharma Group, Glattbrugg.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Burckhardt', 'Affiliation': 'Vifor Pharma Group, Glattbrugg.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Hider', 'Affiliation': ""King's College London (KCL) Institute of Pharmaceutical Science; London Metallomics Consortium.""}]",Haematologica,['10.3324/haematol.2020.250803']
359,33280397,Effectiveness of self-applied acupressure for cervical pain of benign origin (EDIDO-CUH): a randomized controlled clinical trial.,"BACKGROUND


Cervical pain is a problem with a high prevalence of ~13% of the population, and is more common in women (16.5%). The most affected age group is 65-74 years. Our aim was to assess the effectiveness of self-applied acupressure for decreasing benign-origin cervical pain, under the supervision of a health professional and in combination with usual treatment, as well as to examine its impact on the patient's self-perceived health condition and their opinion of the technique.
METHODS


Pragmatic, multicenter, controlled clinical trial randomized by healthcare center. A total of 160 patients with benign-origin cervical pain between 18 and 65 years of age who attended primary care were included from 12 healthcare centers in the autonomous community of Madrid by consecutive sampling, and randomly assigned to a control or intervention group. The main outcome variable was pain intensity measured on a visual analogue scale (VAS) and secondary variables were self-perceived quality of life (EuroQol-5D utility index) and functional ability (neck disability index). An explanative model of generalized estimating equations was built taking into account the lack of independence among observations. The analysis was performed over 6 months.
RESULTS


In total, 150 patients completed the study. Mean age was 45 years (SD: 10.7), 86.7% were women, 86.2% were currently employed, and 57.9% did not perform any physical exercise. Average days experiencing pain was 32.9 (SD: 2.8) and 80% were undergoing previous pharmacological treatment. The quality of life utility index after 3 months was 1.6 points (95% CI: 0.54-2.71) higher in the intervention group. The pain score on the VAS was 0.16 points (95% CI: 0.80-0.48) lower in the intervention group. The health professional explained 10.4% of the reduction in pain observed on the VAS throughout the medical visits.
CONCLUSION


Acupressure applied in addition to usual practice appeared to improve cervical pain in the long term. The effectiveness of this technique was partially explained by the health professional that trained the participants on technique application.
TRIAL REGISTRATION NUMBER:


NCT01855893.",2021,The pain score on the VAS was 0.16 points (95% CI: 0.80-0.48) lower in the intervention group.,"['150 patients completed the study', 'cervical pain of benign origin (EDIDO-CUH', 'Mean age was 45\u2009years (SD: 10.7), 86.7% were women, 86.2% were currently employed, and 57.9% did not perform any physical exercise', '160 patients with benign-origin cervical pain between 18 and 65\u2009years of age who attended primary care were included from 12 healthcare centers in the autonomous community of Madrid by consecutive sampling']","['Acupressure', 'self-applied acupressure', 'control or intervention group']","['pain score', 'pain intensity measured on a visual analogue scale (VAS) and secondary variables were self-perceived quality of life (EuroQol-5D utility index) and functional ability (neck disability index', 'quality of life utility index', 'cervical pain', 'pain', 'Average days experiencing pain']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",160.0,0.153213,The pain score on the VAS was 0.16 points (95% CI: 0.80-0.48) lower in the intervention group.,"[{'ForeName': 'Calvo Trujillo', 'Initials': 'CT', 'LastName': 'Susana', 'Affiliation': 'Primary Care Carabanchel Alto, Gerencia Asistencial de Atención Primaria), SERMAS, Madrid, Spain.'}, {'ForeName': 'Toribio Martín Luisa', 'Initials': 'TML', 'LastName': 'Maria', 'Affiliation': 'Primary Care Becerril de la Sierra, Gerencia Asistencial de Atención Primaria, SERMAS, Madrid, Spain.'}, {'ForeName': 'Domenech Senra', 'Initials': 'DS', 'LastName': 'Pilar', 'Affiliation': 'Primary Care Santa Mónica, Gerencia Asistencial de Atención Primaria, SERMAS, Madrid, Spain.'}, {'ForeName': 'Mingo Moreno Teresa', 'Initials': 'MMT', 'LastName': 'María', 'Affiliation': 'Primary Care Maqueda. Gerencia Asistencial de Atención Primaria, SERMAS, Madrid, Spain.'}, {'ForeName': 'Marín Solano', 'Initials': 'MS', 'LastName': 'Pilar', 'Affiliation': 'Primary Care Martinez de la Riva, Gerencia Asistencial de Atención Primaria, SERMAS, Madrid, Spain.'}, {'ForeName': 'Martín González', 'Initials': 'MG', 'LastName': 'Valentín', 'Affiliation': '6San José Hospital, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420961398']
360,33297893,The multiarm optimization of stroke thrombolysis phase 3 acute stroke randomized clinical trial: Rationale and methods.,"BACKGROUND


Intravenous recombinant tissue plasminogen activator is the only proven effective medication for the treatment of acute ischemic stroke. Two approaches that may augment recombinant tissue plasminogen activator thrombolysis and prevent arterial reocclusion are direct thrombin inhibition with argatroban and inhibition of the glycoprotein 2b/3a receptor with eptifibatide.
AIM


The multi-arm optimization of stroke thrombolysis trial aims to determine the safety and efficacy of intravenous therapy with argatroban or eptifibatide as compared with placebo in acute ischemic stroke patients treated with intravenous recombinant tissue plasminogen activator within 3 h of symptom onset.
SAMPLE SIZE ESTIMATE


A maximum of 1200 randomized subjects to test the superiority of argatroban or eptifibatide to placebo in improving 90-day modified Rankin scores.
METHODS AND DESIGN


Multiarm optimization of stroke thrombolysis is a multicenter, multiarm, adaptive, single blind, randomized controlled phase 3 clinical trial conducted within the National Institutes of Health StrokeNet clinical trial network. Patients treated with 0.9 mg/kg intravenous recombinant tissue plasminogen activator within 3 h of stroke symptom onset are randomized to receive intravenous argatroban (100 µg/kg bolus followed by 3 µg/kg/min for 12 h), intravenous eptifibatide (135 µg/kg bolus followed by 0.75 µg/kg/min infusion for 2 h) or IV placebo. Patients may receive endovascular thrombectomy per usual care.
STUDY OUTCOMES


The primary efficacy outcome is improved modified Rankin score assessed at 90 days post-randomization.
DISCUSSION


Multiarm optimization of stroke thrombolysis is an innovative and collaborative project that is the culmination of many years of dedicated efforts to improve outcomes for stroke patients.",2021,"A maximum of 1200 randomized subjects to test the superiority of argatroban or eptifibatide to placebo in improving 90-day modified Rankin scores.
","['acute ischemic stroke patients treated with', 'stroke patients']","['glycoprotein', 'recombinant tissue plasminogen activator', 'endovascular thrombectomy per usual care', 'placebo', 'intravenous eptifibatide', 'intravenous argatroban', 'eptifibatide', 'intravenous recombinant tissue plasminogen activator', 'argatroban or eptifibatide to placebo', 'argatroban or eptifibatide']","['modified Rankin score assessed at 90 days post-randomization', 'safety and efficacy', '90-day modified Rankin scores']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0253563', 'cui_str': 'eptifibatide'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}]","[{'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1200.0,0.380895,"A maximum of 1200 randomized subjects to test the superiority of argatroban or eptifibatide to placebo in improving 90-day modified Rankin scores.
","[{'ForeName': 'S Iris', 'Initials': 'SI', 'LastName': 'Deeds', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Barreto', 'Affiliation': 'Department of Neurology, University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Elm', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'Derdeyn', 'Affiliation': 'Department of Radiology, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC., Austin, TX, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Khatri', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Moy', 'Affiliation': '35046National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Janis', 'Affiliation': '35046National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Grotta', 'Affiliation': 'Memorial Hermann Hospital - Texas Medical Center, Houston, TX, USA.'}, {'ForeName': 'Opeolu', 'Initials': 'O', 'LastName': 'Adeoye', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020978345']
361,33301667,Incongruent Expression of Brain-Derived Neurotrophic Factor and Cortisol in Schizophrenia: Results from a Randomized Controlled Trial of Laughter Intervention.,"OBJECTIVE


Schizophrenia has been associated with dysfunction of the hypothalamic-pituitary-adrenal axis. Furthermore, alterations in neurotrophic factors might contribute to the pathogenesis of schizophrenia. We aimed to evaluate the effects of a simulated laughter intervention on the levels of cortisol and BDNF and to determine whether the effects associated with simulated laughter could be sustained after discontinuation of the intervention.
METHODS


In this randomized controlled study, patients with schizophrenia according to DSM-IV clinical criteria were randomly assigned to receive either 8-week-long simulated laughter intervention (n=32) or treatment-as-usual group (control group, n=27). The serum levels of BDNF and cortisol were measured at baseline, week 8, and four weeks after discontinuation (week 12) of the intervention program.
RESULTS


After an 8-week simulated laughter intervention, the laughter group had significantly higher levels of BDNF; however, four weeks after discontinuation of the intervention, the levels of BDNF significantly dropped. Interestingly, the levels of cortisol did not change significantly at week 8, but they were significantly elevated at week 12. The levels of BDNF and cortisol in the control group did not change significantly between week 0 and week 8.
CONCLUSION


These findings suggest that the simulated laughter intervention has an early effect on neurogenesis with a significant delayed effect on stress regulation in subjects with schizophrenia.",2020,"After an 8-week simulated laughter intervention, the laughter group had significantly higher levels of BDNF; however, four weeks after discontinuation of the intervention, the levels of BDNF significantly dropped.","['subjects with schizophrenia', 'patients with schizophrenia according to DSM-IV clinical criteria', 'Schizophrenia']","['8-week-long simulated laughter intervention (n=32) or treatment-as-usual group (control group', 'simulated laughter intervention']","['stress regulation', 'levels of BDNF and cortisol', 'levels of BDNF', 'levels of cortisol', 'levels of cortisol and BDNF', 'serum levels of BDNF and cortisol']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0023133', 'cui_str': 'Laughing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0191818,"After an 8-week simulated laughter intervention, the laughter group had significantly higher levels of BDNF; however, four weeks after discontinuation of the intervention, the levels of BDNF significantly dropped.","[{'ForeName': 'Shu-Li', 'Initials': 'SL', 'LastName': 'Cheng', 'Affiliation': 'Department of Nursing, Mackay Medical College, Taipei, Taiwan, ROC.'}, {'ForeName': 'Fu-Chi', 'Initials': 'FC', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC.'}, {'ForeName': 'Hsuan-Te', 'Initials': 'HT', 'LastName': 'Chu', 'Affiliation': 'Department of Psychiatry, Beitou Branch, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chia-Kuang', 'Initials': 'CK', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shih-Chieh', 'Initials': 'SC', 'LastName': 'Ku', 'Affiliation': 'Department of Psychiatry, Beitou Branch, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC.'}, {'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Tseng', 'Affiliation': 'Department of Psychiatry, Beitou Branch, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ta-Chuan', 'Initials': 'TC', 'LastName': 'Yeh', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chih-Sung', 'Initials': 'CS', 'LastName': 'Liang', 'Affiliation': 'Department of Psychiatry, Beitou Branch, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC.'}]",Psychiatry investigation,['10.30773/pi.2020.0269']
362,33307814,Moderating Effects of Gender Among Collegiate Student-Athletes Receiving a Novel Peer Concussion Education Program.,"BACKGROUND


More than 460,000 female and male student-athletes compete in college sports each year, with 5.5 concussions reported per 1,000 athlete exposures. The majority of these concussions occurred during competition and are somewhat more likely to be reported by female athletes.
AIMS


To evaluate moderating effects of gender differences in response to a Peer Concussion Education Program (PCEP).
METHOD


A total of 1,100 male and 511 female student-athletes from 60 teams (30 experimental, 30 control) representing all National Collegiate Athletic Association divisions from high-concussive sports participated before, postintervention, and 1-month following the intervention. Participants completed assessments of symptom and return-to-play knowledge, reporting behavior, and reporting attitudes.
RESULTS


The PCEP was more effective than control on all measures, females in the PCEP showed significantly greater changes than males in return to play knowledge, intention to report self and teammate, and indirect attitudes for self and teammate. PCEP females were more likely to discuss concussions with athletic trainers, peers, and teammates. In addition, females had a higher likelihood of reporting their own suspected concussion.
DISCUSSION


Females had greater rates of change in understanding of some key components of the PCEP.
CONCLUSION


These findings suggest that females may learn differently in a peer environment and have different attitudes toward reporting and safety when consideration is given to the well-being of others.",2021,"The PCEP was more effective than control on all measures, females in the PCEP showed significantly greater changes than males in return to play knowledge, intention to report self and teammate, and indirect attitudes for self and teammate.","['Collegiate Student-Athletes', '460,000 female and male student-athletes compete in college sports each year, with 5.5 concussions reported per 1,000 athlete exposures', '1,100 male and 511 female student-athletes from 60 teams (30 experimental, 30 control) representing all National Collegiate Athletic Association divisions from high-concussive sports participated before, postintervention, and 1-month following the intervention']",['Peer Concussion Education Program (PCEP'],"['symptom and return-to-play knowledge, reporting behavior, and reporting attitudes']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",1100.0,0.0270662,"The PCEP was more effective than control on all measures, females in the PCEP showed significantly greater changes than males in return to play knowledge, intention to report self and teammate, and indirect attitudes for self and teammate.","[{'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Kneavel', 'Affiliation': 'La Salle University, Philadelphia, PA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ernst', 'Affiliation': 'Chestnut Hill College, Philadelphia, PA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McCarthy', 'Affiliation': 'Chestnut Hill College, Philadelphia, PA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198120977128']
363,33262435,Consistency of hemodynamic and autonomic mechanisms underlying post-exercise hypotension.,"Post-exercise hypotension (PEH) is a clinically relevant phenomenon, but its mechanisms vary between different studies and between the participants within each study. Additionally, it is possible that PEH mechanisms are not consistent in each individual (i.e. within-individual variation), which has not been investigated yet. Thus, the aim of the current study was to assess the within-individual consistency of PEH hemodynamic and autonomic mechanisms. For that, 30 subjects performed 4 sessions divided in 2 blocks (test and retest). In each block, an exercise (cycling, 45 min, 50%VO 2 peak) and a control (seated rest, 45 min) session was randomly conducted. Blood pressure (BP) and its mechanisms were evaluated pre- and post-interventions. In each block, individual responses were calculated as post-exercise minus post-control, and a response was considered present when its magnitude reached the typical error of the measurement. Consistencies were evaluated by comparing test and retest responses through kappa coefficient (k). PEH consistency was calculated using role sample, while mechanisms consistency was evaluated in those with consistent PEH. Twenty-one (70%) participants showed consistent PEH, 5 (17%) presented PEH in only test or retest and 4 (13%) had absent PEH response, characterising a good consistency (k = 0.510). Regarding mechanisms' responses, good consistency was found for heart rate (k = 0.456), sympathovagal balance (k = 0.438), and baroreflex sensitivity (k = 0.458); while systemic vascular resistance (k = 0.152), cardiac output (k = -0.400), stroke volume (k = -0.055), and sympathetic vasomotor modulation (k = -0.096) presented marginal consistencies. Thus, PEH is a highly consistent physiological phenomenon, although its mechanisms present variable consistencies.",2021,"Regarding mechanisms' responses, good consistency was found for heart rate (k = 0.456), sympathovagal balance (k = 0.438), and baroreflex sensitivity (k = 0.458); while systemic vascular resistance (k = 0.152), cardiac output (k = -0.400), stroke volume (k = -0.055), and sympathetic vasomotor modulation (k = -0.096) presented marginal consistencies.",[],['Post-exercise hypotension (PEH'],"['cardiac output', 'stroke volume', 'heart rate', 'absent PEH response', 'Blood pressure (BP', 'systemic vascular resistance', 'sympathetic vasomotor modulation', 'baroreflex sensitivity', 'sympathovagal balance', 'PEH consistency']",[],"[{'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]",,0.049415,"Regarding mechanisms' responses, good consistency was found for heart rate (k = 0.456), sympathovagal balance (k = 0.438), and baroreflex sensitivity (k = 0.458); while systemic vascular resistance (k = 0.152), cardiac output (k = -0.400), stroke volume (k = -0.055), and sympathetic vasomotor modulation (k = -0.096) presented marginal consistencies.","[{'ForeName': 'Rafael Yokoyama', 'Initials': 'RY', 'LastName': 'Fecchio', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Leandro C', 'Initials': 'LC', 'LastName': 'Brito', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Peçanha', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cláudia Lúcia de Moraes', 'Initials': 'CLM', 'LastName': 'Forjaz', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil. cforjaz@usp.br.'}]",Journal of human hypertension,['10.1038/s41371-020-00452-w']
364,33260274,A pilot trial of moderated online social therapy for family and friends of young people with borderline personality disorder features.,"AIM


We evaluated the acceptability, usability and safety of Kindred, a novel online intervention for carers of young people with borderline personality disorder (BPD) using a pre-post pilot trial design. The secondary aim explored whether Kindred use was associated with clinical improvements for caregivers on measures of burden of caregiving, stress, expressed emotion, family communication, disability, coping and knowledge of BPD and for patients on measures of severity of BPD symptoms and level of functional impairment.
METHODS


The trial site was the Helping Young People Early program for young people with BPD at Orygen in Melbourne, Australia. Informed consent was obtained from 20 adult carers (i.e., relatives or friends) and 10 young people aged 15-25 with BPD. Kindred, which was available for 3 months, incorporated online psychoeducation, carer-to-carer social networking and guidance from expert and peer moderators. Assessments were completed at baseline and 3 months follow-up. Multiple indicators of acceptability, usability and safety were utilized.
RESULTS


Seventeen carers were enrolled in Kindred and eight young people completed baseline measures. A priori acceptability, usability and safety criteria were met. Carer burden, stress, expressed emotion, family communication, quality of life, functioning, coping and perceived knowledge of BPD improved at follow-up. Sixty-six percent of the young people (4/6) reported that they believed Kindred had improved their carers' understanding of BPD.
CONCLUSION


Kindred was shown to be acceptable, usable and safe, with encouraging improvements in both carer and young person outcomes. Kindred warrants evaluation of its efficacy via an randomized controlled trial.",2021,"AIM


We evaluated the acceptability, usability and safety of Kindred, a novel online intervention for carers of young people with borderline personality disorder (BPD) using a pre-post pilot trial design.","['20 adult carers (i.e., relatives or friends) and 10 young people aged 15-25 with BPD', 'carers of young people with borderline personality disorder (BPD', 'Seventeen carers', 'young people with BPD at Orygen in Melbourne, Australia', 'family and friends of young people with borderline personality disorder features']","['novel online intervention', 'moderated online social therapy']","['Carer burden, stress, expressed emotion, family communication, quality of life, functioning, coping and perceived knowledge of BPD', 'acceptability, usability and safety', 'burden of caregiving, stress, expressed emotion, family communication, disability, coping and knowledge of BPD', 'BPD symptoms and level of functional impairment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0740117', 'cui_str': 'Social therapy'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",17.0,0.0815951,"AIM


We evaluated the acceptability, usability and safety of Kindred, a novel online intervention for carers of young people with borderline personality disorder (BPD) using a pre-post pilot trial design.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gleeson', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Betts', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McCutcheon', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Jovev', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Reeva', 'Initials': 'R', 'LastName': 'Lederman', 'Affiliation': 'School of Computing and Information Systems, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Herrman', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bendall', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'McKechnie', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Burke', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Koval', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': ""D'Alfonso"", 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Sumudu', 'Initials': 'S', 'LastName': 'Mallawaarachchi', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Chanen', 'Affiliation': 'Orygen, Melbourne, Australia.'}]",Early intervention in psychiatry,['10.1111/eip.13094']
365,33274389,"Residual, differential neurobehavioral deficits linger after multiple recovery nights following chronic sleep restriction or acute total sleep deprivation.","STUDY OBJECTIVES


The amount of recovery sleep needed to fully restore well-established neurobehavioral deficits from sleep loss remains unknown, as does whether the recovery pattern differs across measures after total sleep deprivation (TSD) and chronic sleep restriction (SR).
METHODS


In total, 83 adults received two baseline nights (10-12-hour time in bed [TIB]) followed by five 4-hour TIB SR nights or 36-hour TSD and four recovery nights (R1-R4; 12-hour TIB). Neurobehavioral tests were completed every 2 hours during wakefulness and a Maintenance of Wakefulness Test measured physiological sleepiness. Polysomnography was collected on B2, R1, and R4 nights.
RESULTS


TSD and SR produced significant deficits in cognitive performance, increases in self-reported sleepiness and fatigue, decreases in vigor, and increases in physiological sleepiness. Neurobehavioral recovery from SR occurred after R1 and was maintained for all measures except Psychomotor Vigilance Test (PVT) lapses and response speed, which failed to completely recover. Neurobehavioral recovery from TSD occurred after R1 and was maintained for all cognitive and self-reported measures, except for vigor. After TSD and SR, R1 recovery sleep was longer and of higher efficiency and better quality than R4 recovery sleep.
CONCLUSIONS


PVT impairments from SR failed to reverse completely; by contrast, vigor did not recover after TSD; all other deficits were reversed after sleep loss. These results suggest that TSD and SR induce sustained, differential biological, physiological, and/or neural changes, which remarkably are not reversed with chronic, long-duration recovery sleep. Our findings have critical implications for the population at large and for military and health professionals.",2021,"Neurobehavioral recovery from TSD occurred after R1 and was maintained for all cognitive and self-reported measures, except for vigor.",['chronic sleep restriction or acute total sleep deprivation'],[],"['self-reported sleepiness and fatigue', 'Psychomotor Vigilance Test (PVT) lapses and response speed', 'Neurobehavioral recovery from TSD', 'Neurobehavioral tests', 'cognitive performance', 'Neurobehavioral recovery from SR', 'physiological sleepiness', 'total sleep deprivation (TSD) and chronic sleep restriction (SR', 'SR, R1 recovery sleep']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]",83.0,0.0223471,"Neurobehavioral recovery from TSD occurred after R1 and was maintained for all cognitive and self-reported measures, except for vigor.","[{'ForeName': 'Erika M', 'Initials': 'EM', 'LastName': 'Yamazaki', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Antler', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Charlotte R', 'Initials': 'CR', 'LastName': 'Lasek', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}]",Sleep,['10.1093/sleep/zsaa224']
366,33289308,Forty-eight weeks of statin therapy for type 2 diabetes mellitus patients with lower extremity atherosclerotic disease: Comparison of the effects of pitavastatin and atorvastatin on lower femoral total plaque areas.,"AIMS/INTRODUCTION


Type 2 diabetes mellitus is correlated with systemic atherosclerosis. Statin therapies have been proved to reduce low-density lipoprotein cholesterol (LDL-C) level, protecting type 2 diabetes mellitus patients from cardiovascular events. Recently, more interest has been focused on the regression of lower extremity atherosclerotic disease (LEAD) for the potential prevention of amputation. However, the effects of pitavastatin and atorvastatin on LEAD in type 2 diabetes mellitus patients have not been directly compared.
MATERIALS AND METHODS


This study compared the effects of pitavastatin and atorvastatin on femoral total plaque areas (FTPA), and lipids and glucose metabolism in type 2 diabetes mellitus patients with elevated LDL-C level and LEAD. Type 2 diabetes mellitus patients with LDL-C level >2.6 mmol/L and LEAD were randomly assigned to receive either pitavastatin 2 mg/day or atorvastatin 10 mg/day for 48 weeks. FTPA were measured at baseline and the end of the study. Levels of glucose and lipids profile were measured periodically. The efficacy was evaluated in 63 patients.
RESULTS


The percentage change in FTPA measurements was similar between the pitavastatin group and atorvastatin group (-17.79 ± 21.27% vs -14.34 ± 16.33%), as were the changes in LDL-C (-44.0 ± 18.0% vs -40.3 ± 18.2%) and triglyceride (17.6 ± 20.0% vs 16.2 ± 17.0%). However, the level of high-density lipoprotein cholesterol was significantly higher in the pitavastatin group compared with the atorvastatin group after 48 weeks of treatment (12.9 ± 10.3% vs 7.2 ± 11.7%, P < 0.05). There were no significant differences between groups for the measurements of glucose metabolism.
CONCLUSION


In type 2 diabetes mellitus patients with elevated LDL-C level and LEAD, 48 weeks of treatment with either pitavastatin or atorvastatin was associated with significant regression of FTPA. Pitavastatin treatment resulted in a significantly higher high-density lipoprotein cholesterol level compared with atorvastatin treatment.",2021,"But the level of high-density lipoprotein cholesterol (HDL-C) was significantly higher in the pitavastatin group compared with the atorvastatin group after 48 weeks of treatment (12.9±10.3% vs 7.2±11.7%, P<0.05).","['T2DM patients with LEAD', '63 patients', 'T2DM patients with LDL-C level > 2.6mmol/L and LEAD', 'T2DM patients with elevated LDL-C level and LEAD']","['pitavastatin and atorvastatin', 'pitavastatin or atorvastatin', 'pitavastatin', 'statin therapy', 'Pitavastatin', 'pitavastatin 2mg/d or atorvastatin', 'atorvastatin']","['femoral total plaque areas (FTPA), and lipids and glucose metabolism', 'LDL-C', 'FTPA', 'triglyceride', 'FTPA measurements', 'Levels of glucose and lipids profile', 'level of high-density lipoprotein cholesterol (HDL-C', 'HDL-C level', 'low-density lipoprotein cholesterol (LDL-C) level', 'glucose metabolism']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",63.0,0.0400973,"But the level of high-density lipoprotein cholesterol (HDL-C) was significantly higher in the pitavastatin group compared with the atorvastatin group after 48 weeks of treatment (12.9±10.3% vs 7.2±11.7%, P<0.05).","[{'ForeName': 'Xieda', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Huangmeng', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yanbing', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiaopei', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}]",Journal of diabetes investigation,['10.1111/jdi.13472']
367,33292873,Adjunctive yoga training for persons with schizophrenia: who benefits?,"OBJECTIVE


The aim of this study was to identify factors associated with acceptability and efficacy of yoga training (YT) for improving cognitive dysfunction in individuals with schizophrenia (SZ).
METHODS


We analysed data from two published clinical trials of YT for cognitive dysfunction among Indians with SZ: (1) a 21-day randomised controlled trial (RCT, N = 286), 3 and 6 months follow-up and (2) a 21-day open trial (n = 62). Multivariate analyses were conducted to examine the association of baseline characteristics (age, sex, socio-economic status, educational status, duration, and severity of illness) with improvement in cognition (i.e. attention and face memory) following YT. Factors associated with acceptability were identified by comparing baseline demographic variables between screened and enrolled participants as well as completers versus non-completers.
RESULTS


Enrolled participants were younger than screened persons who declined participation (t = 2.952, p = 0.003). No other characteristics were associated with study enrollment or completion. Regarding efficacy, schooling duration was nominally associated with greater and sustained cognitive improvement on a measure of facial memory. No other baseline characteristics were associated with efficacy of YT in the open trial, the RCT, or the combined samples (n = 148).
CONCLUSIONS


YT is acceptable even among younger individuals with SZ. It also enhances specific cognitive functions, regardless of individual differences in selected psychosocial characteristics. Thus, yoga could be incorporated as adjunctive therapy for patients with SZ. Importantly, our results suggest cognitive dysfunction is remediable in persons with SZ across the age spectrum.",2021,"Enrolled participants were younger than screened persons who declined participation (t=2.952, p=0.003).","['persons with schizophrenia', 'persons with SZ across the age spectrum', 'younger individuals with SZ', 'patients with SZ', 'individuals with schizophrenia (SZ', 'Enrolled participants were younger than screened persons who declined participation (t=2.952, p=0.003']","['Adjunctive Yoga training', 'yoga training (YT']","['cognitive dysfunction', 'facial memory', 'baseline characteristics (age, sex, socio-economic status, educational status, duration and severity of illness) with improvement in cognition (i.e., attention and face memory', 'specific cognitive functions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0636522,"Enrolled participants were younger than screened persons who declined participation (t=2.952, p=0.003).","[{'ForeName': 'Triptish', 'Initials': 'T', 'LastName': 'Bhatia', 'Affiliation': 'Indo-USA Projects and NCU-ICMR, Department of Psychiatry and De-addiction, Centre of Excellence in Mental Health, ABVIMS. -Dr. R.M.L. Hospital, New Delhi, India.'}, {'ForeName': 'Swathi', 'Initials': 'S', 'LastName': 'Gujral', 'Affiliation': 'VA VISN 4 Mental Illness Research, Education, and Clinical Center of Excellence (MIRECC), VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'NCU-ICMR, Department of Psychiatry and De-addiction, Centre of Excellence in Mental Health, ABVIMS. -Dr.R.M.L. Hospital, New Delhi, India.'}, {'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Kumari', 'Affiliation': 'SATYAM-DST Project, Department of Psychiatry and De-addiction, Centre of Excellence in Mental Health, ABVIMS. -Dr.R.M.L. Hospital, New Delhi, India.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Western Psychiatric Hospital, Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Maribeth A', 'Initials': 'MA', 'LastName': 'Wesesky', 'Affiliation': 'Western Psychiatric Hospital, Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jacquelynn', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Western Psychiatric Hospital, Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Louanne W', 'Initials': 'LW', 'LastName': 'Davis', 'Affiliation': 'Department of Research, Roudebush VA Medical Center, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Iyenger', 'Affiliation': 'Department of Statistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Gretchen L', 'Initials': 'GL', 'LastName': 'Haas', 'Affiliation': 'VA VISN 4 Mental Illness Research, Education, and Clinical Center of Excellence (MIRECC), VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}, {'ForeName': 'Vishwajit L', 'Initials': 'VL', 'LastName': 'Nimgaonkar', 'Affiliation': 'Western Psychiatric Hospital, Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Smita N', 'Initials': 'SN', 'LastName': 'Deshpande', 'Affiliation': 'Department of Psychiatry and De-addiction, Centre of Excellence in Mental Health, ABVIMS. -Dr.R.M.L. Hospital, New Delhi, India.'}]",Acta neuropsychiatrica,['10.1017/neu.2020.44']
368,33303397,"Along or across the visual axis: a comparison of two ultrasound screen, needle and transducer orientation techniques.","OBJECTIVE


To evaluate two transducer and needle handling methods, along the visual axis (AL) and across the visual axis (AC), in non-skilled and skilled clinicians.
STUDY DESIGN


Prospective randomized crossover study.
METHOD


A total of 26 students with no ultrasound locoregional anaesthesia experience (non-skilled group) and six clinicians experienced and familiar with ultrasound locoregional anaesthesia (skilled group) were enrolled. The non-skilled group was asked to perform two tasks: the first on a phantom and the second on canine cadavers, whilst the skilled group performed only the second task. The tasks consisted of guiding the tip of the needle to a target point (simulated nerve on the jelly phantom and sciatic nerve on the cadavers) using two different methods of needle handling-AL or AC. All operators performed each task three times for each method. The time to drive the needle to the target for the two methods was analysed with a paired Student t test, and the number of times the needle was not visualized on the screen between the groups was compared using an unpaired Student t test. Data are presented as mean ± standard deviation. Value of p < 0.05 was considered significant.
RESULTS


The AL method, compared with the AC method, resulted in shorter performance time in both skilled (9 ± 5 versus 20 ± 8 seconds for the second task) and non-skilled groups (9 ± 8 versus 17 ± 15 seconds for the first task and 18 ± 11 versus 32 ± 26 seconds for the second task).
CONCLUSION AND CLINICAL RELEVANCE


In both groups, the AL method significantly reduced the time to complete the task. Results from this study indicate that the AL method should be the preferred method for learning/teaching ultrasound-guided regional anaesthesia.",2021,"The AL method, compared with the AC method, resulted in shorter performance time in both skilled (9 ± 5 versus 20 ± 8 seconds for the second task) and non-skilled groups (9 ± 8 versus 17 ± 15 seconds for the first task and 18 ± 11 versus 32 ± 26 seconds for the second task).
",['26 students with no ultrasound locoregional anaesthesia experience (non-skilled group) and six clinicians experienced and familiar with ultrasound locoregional anaesthesia (skilled group) were enrolled'],['guiding the tip of the needle to a target point (simulated nerve on the jelly phantom and sciatic nerve on the cadavers) using two different methods of needle handling-AL or AC'],['shorter performance time'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0036394', 'cui_str': 'Structure of sciatic nerve'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",26.0,0.0129022,"The AL method, compared with the AC method, resulted in shorter performance time in both skilled (9 ± 5 versus 20 ± 8 seconds for the second task) and non-skilled groups (9 ± 8 versus 17 ± 15 seconds for the first task and 18 ± 11 versus 32 ± 26 seconds for the second task).
","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Di Franco', 'Affiliation': 'Department of Veterinary Sciences, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Hamaseh', 'Initials': 'H', 'LastName': 'Tayari', 'Affiliation': 'School of Veterinary Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Samanta', 'Initials': 'S', 'LastName': 'Nardi', 'Affiliation': 'Department of Veterinary Sciences, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Briganti', 'Affiliation': 'Department of Veterinary Sciences, University of Pisa, Pisa, Italy. Electronic address: angela.briganti@unipi.it.'}]",Veterinary anaesthesia and analgesia,['10.1016/j.vaa.2020.08.009']
369,33031764,"Lopinavir-ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.","BACKGROUND


Lopinavir-ritonavir has been proposed as a treatment for COVID-19 on the basis of in vitro activity, preclinical studies, and observational studies. Here, we report the results of a randomised trial to assess whether lopinavir-ritonavir improves outcomes in patients admitted to hospital with COVID-19.
METHODS


In this randomised, controlled, open-label, platform trial, a range of possible treatments was compared with usual care in patients admitted to hospital with COVID-19. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus lopinavir-ritonavir (400 mg and 100 mg, respectively) by mouth for 10 days or until discharge (or one of the other RECOVERY treatment groups: hydroxychloroquine, dexamethasone, or azithromycin) using web-based simple (unstratified) randomisation with allocation concealment. Randomisation to usual care was twice that of any of the active treatment groups (eg, 2:1 in favour of usual care if the patient was eligible for only one active group, 2:1:1 if the patient was eligible for two active groups). The primary outcome was 28-day all-cause mortality. Analyses were done on an intention-to-treat basis in all randomly assigned participants. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.
FINDINGS


Between March 19, 2020, and June 29, 2020, 1616 patients were randomly allocated to receive lopinavir-ritonavir and 3424 patients to receive usual care. Overall, 374 (23%) patients allocated to lopinavir-ritonavir and 767 (22%) patients allocated to usual care died within 28 days (rate ratio 1·03, 95% CI 0·91-1·17; p=0·60). Results were consistent across all prespecified subgroups of patients. We observed no significant difference in time until discharge alive from hospital (median 11 days [IQR 5 to >28] in both groups) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 0·98, 95% CI 0·91-1·05; p=0·53). Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who met the composite endpoint of invasive mechanical ventilation or death (risk ratio 1·09, 95% CI 0·99-1·20; p=0·092).
INTERPRETATION


In patients admitted to hospital with COVID-19, lopinavir-ritonavir was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death. These findings do not support the use of lopinavir-ritonavir for treatment of patients admitted to hospital with COVID-19.
FUNDING


Medical Research Council and National Institute for Health Research.",2020,"Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who met the composite endpoint of invasive mechanical ventilation or death (risk ratio 1·09, 95% CI 0·99-1·20; p=0·092).
","['and 3424 patients to receive', 'Between March 19, 2020, and June 29, 2020, 1616 patients', 'patients admitted to hospital with COVID-19 (RECOVERY', '176 hospitals in the UK', 'Eligible and consenting patients', 'patients admitted to hospital with COVID-19']","['Lopinavir-ritonavir', 'usual standard of care alone or usual standard of care plus lopinavir-ritonavir', 'lopinavir-ritonavir', 'usual care', 'hydroxychloroquine, dexamethasone, or azithromycin']","['time until discharge alive from hospital', '28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death', '28-day all-cause mortality', 'composite endpoint of invasive mechanical ventilation or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",1616.0,0.208399,"Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who met the composite endpoint of invasive mechanical ventilation or death (risk ratio 1·09, 95% CI 0·99-1·20; p=0·092).
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32013-4']
370,33063862,"Efficacy of Galcanezumab for Migraine Prevention in Patients With a Medical History of Anxiety and/or Depression: A Post Hoc Analysis of the Phase 3, Randomized, Double-Blind, Placebo-Controlled REGAIN, and Pooled EVOLVE-1 and EVOLVE-2 Studies.","OBJECTIVE


This post hoc analysis evaluated the efficacy of galcanezumab for the prevention of migraine in patients with and without comorbid anxiety and/or depression.
BACKGROUND


Patients with migraine have a higher risk of anxiety and/or depression. Given the high prevalence of psychiatric symptoms and their potential negative prognostic impact, determining the efficacy of migraine treatments in patients with these comorbidities is important.
METHODS


The results of 2 phase 3 episodic migraine studies of patients with 4-14 migraine headache days (MHD) per month were pooled. A third chronic migraine study, which was evaluated separately, enrolled patients with ≥15 headache days per month, of which ≥8 had migraine-like features. Patients in all 3 studies were randomized 2:1:1 to placebo, galcanezumab 120 mg, or galcanezumab 240 mg. The efficacy of galcanezumab on migraine was measured in subgroups of patients with anxiety and/or depression (current or past) and patients without. A repeated measures model was used to compare treatment groups within each subgroup and to test for consistency of treatment effect across the anxiety/depression subgroups (subgroup-by-treatment interaction) during the double-blind treatment phases.
RESULTS


Among 1773 intent-to-treat patients with episodic migraine, both doses of galcanezumab demonstrated statistically significant improvements relative to placebo in overall number of MHD for the subgroups of patients with anxiety and/or depression (mean change difference from placebo [95% CI]: -2.07 [-2.81, -1.33] for galcanezumab 120 mg [P < .001], -1.91 [-2.78, -1.04] for 240 mg [P < .001]) and without anxiety and/or depression (mean change difference from placebo [95% CI]: -1.92 [-2.36, -1.47] for 120 mg [P < .001], -1.77 [-2.20, -1.33] for 240 mg [P < .001]), as was observed for the secondary outcomes of MHD with acute medication use and functional impairment. Among 1113 intent-to-treat patients with chronic migraine, those with anxiety and/or depression had significant reductions in overall MHD frequency with the 240-mg dose (mean change difference from placebo [95% CI]: -1.92 [-3.52, -0.33]; P = .018), whereas significant reductions were observed at both the 120-mg (mean change difference from placebo [95% CI]: -2.29 [-3.26, -1.31]; P < .001) and 240-mg (-1.85 [-2.83, -0.87]; P < .001) doses in patients without anxiety and/or depressions. Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression. In the episodic and chronic migraine studies, the subgroup-by-treatment interaction was not statistically significant for MHD, MHD with acute medication use, or functional impairment (chronic study only), suggesting a lack of evidence of differential effect between subgroups. Furthermore, differences between subgroups in the mean change differences from placebo, as well as overlapping 95% confidence intervals for the subgroups, indicated lack of a clinical or statistical difference between subgroups for these outcome variables. There was a significantly higher percentage of patients with episodic migraine attaining ≥50%, ≥75%, and 100% reductions, and a higher percentage of patients with chronic migraine attaining ≥50% and ≥75% reductions from baseline with galcanezumab compared with placebo, regardless of medical history of anxiety and/or depression.
CONCLUSIONS


A medical history of anxiety and/or depression does not seem to interfere with response to galcanezumab among patients with episodic migraine, and both doses of galcanezumab appear efficacious for these individuals regardless of this psychiatric history. Among patients with chronic migraine and comorbid anxiety and/or depression, the 240-mg dose, but not the 120-mg dose, significantly decreased overall MHD, but neither dose resulted in significantly greater functional improvement. Patients with migraine and comorbid anxiety and/or depression often require additional interventions, and this may be more important in chronic migraine.",2020,"Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression.","['enrolled patients with ≥15 headache days per month, of which ≥8 had migraine-like features', 'Patients With a Medical History of Anxiety', 'subgroups of patients with anxiety and/or depression (current or past) and patients without', 'patients with these comorbidities is important', 'Patients with migraine and comorbid anxiety and/or depression often require additional interventions', 'and/or Depression', 'patients with episodic migraine', 'patients with 4-14 migraine headache days (MHD) per month were pooled', 'patients with and without comorbid anxiety and/or depression']","['Galcanezumab', 'galcanezumab', 'placebo', 'placebo, galcanezumab 120\xa0mg, or galcanezumab 240\xa0mg', 'Placebo']","['chronic migraine', 'MHD with acute medication use and functional impairment', 'comorbid anxiety and/or depression', 'migraine', 'anxiety and/or depression', 'overall MHD', 'overall functional impairment', 'functional improvement', 'overall number of MHD', 'episodic migraine', 'overall MHD frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1444635', 'cui_str': 'Current or past'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.162567,"Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression.","[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Smitherman', 'Affiliation': 'Department of Psychology, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Gretchen E', 'Initials': 'GE', 'LastName': 'Tietjen', 'Affiliation': 'Department of Neurology, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Schuh', 'Affiliation': 'Medical Affairs, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Skljarevski', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lipsius', 'Affiliation': 'Department of Statistics, Syneos Health, Raleigh, NC, USA.'}, {'ForeName': 'Deborah N', 'Initials': 'DN', 'LastName': ""D'Souza"", 'Affiliation': 'Clinical Solutions, Syneos Health, Raleigh, NC, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Medical Affairs, Eli Lilly and Company, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.13970']
371,33277091,A study comparing the effect of premedication with intravenous midazolam or dexmedetomidine on ketamine-fentanyl sedoanalgesia in burn patients: A randomized clinical trial.,"INTRODUCTION


Dressing changes and wound care-debridement procedures often cause fear and anxiety in burn patients, as these processes are quite painful. In order to determine the best method for alleviating pain during these procedures, the current study compared the efficacy and safety of intravenous dexmedetomidine and midazolam for premedication prior to these painful burn care procedures.
METHODS


This comparative and randomized study included patients who had a burn size of 1563%, were aged 1870 years, were diagnosed with the American Society of Anesthesiologists physical status (ASA I-II), and who underwent painful burn care procedures. Patients were intravenously administered either 1 mcg/kg dexmedetomidine (Group 1) or 0.03 mg/kg midazolam (Group 2) prior to the burn care procedure. Recorded at predetermined time points for each patient were heart rhythm (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO 2) , standard bispectral index (BIS), and Ramsay Sedation Scale (RSS).
RESULTS


In the dexmedetomidine group, HR and MAP measurements of patients ​​at the 3rd, 5th, and 10th mins during sedation were significantly lower than the baseline values (p < 0.05). A significant decrease in SpO2 was observed in both groups at the 10th min during sedation, but the decline was higher in the midazolam group (p < 0.05). BIS measurements of the patients in both groups were significantly lower at 10 min. during sedation and at 15th and 60th mins during the procedure (p < 0.05). However, there was no significant difference between the group (p > 0.05). The RSS scales of both groups in during the sedation were higher in the 3rd, 5th and 10th mins than the baseline values (p < 0.05), but there was no significant difference between the groups (p > 0.05). The RSS scales of groups in during the burn procedure were significantly higher at 15 th min than the 0 th values, while the RSS scales of both groups were significantly lower in the 45th and 60th mins (p < 0.05).
CONCLUSION


Results of this study indicate that dexmedetomidine causes hemodynamic alterations while midazolam causes respiratory depression. However, these effects are not severe, and we conclude that both agents are safe and effective to ensure sedation prior to painful burn-care procedures.",2021,"The RSS scales of both groups in during the sedation were higher in the 3rd, 5th and 10th mins than the baseline values (p < 0.05), but there was no significant difference between the groups (p > 0.05).","['burn patients', 'patients who had a burn size of 1563%, were aged 1870 years, were diagnosed with the American Society of Anesthesiologists physical status (ASA I-II), and who underwent painful burn care procedures']","['ketamine-fentanyl sedoanalgesia', 'dexmedetomidine', 'midazolam', 'dexmedetomidine and midazolam']","['RSS scales', 'BIS measurements', 'HR and MAP measurements', 'efficacy and safety', 'heart rhythm (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO 2) , standard bispectral index (BIS), and Ramsay Sedation Scale (RSS', 'SpO2']","[{'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1276417', 'cui_str': 'Burn care'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",,0.0251211,"The RSS scales of both groups in during the sedation were higher in the 3rd, 5th and 10th mins than the baseline values (p < 0.05), but there was no significant difference between the groups (p > 0.05).","[{'ForeName': 'Muzaffer', 'Initials': 'M', 'LastName': 'Gencer', 'Affiliation': 'Department of Anesthesia, Istinye University Medical Faculty, Istanbul, Turkey. Electronic address: muzaffer.gencer@isu.edu.tr.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Sezen', 'Affiliation': 'Department of Anesthesia, Dr. Lutfi Kirdar Research and Education Hospital, Istanbul, Turkey. Electronic address: drozlemsezen@hotmail.com.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.05.027']
372,33280953,The efficacy of resistance training in addition to usual care for adults with acute burn injury: A randomised controlled trial.,"Resistance training immediately after a burn injury has not been investigated previously. This randomised, controlled trial assessed the impact of resistance training on quality of life plus a number of physical, functional and safety outcomes in adults with a burn injury. Patients were randomly assigned to receive, in addition to standard physiotherapy, four weeks of high intensity resistance training (RTG) or sham resistance training (CG) three days per week, commenced within 72h of the burn injury. Outcome data was collected at six weeks, three and six months after burn injury. Quality of life at 6 months was the primary endpoint. Data analysis was an available cases analysis with no data imputed. Regression analyses were used for all longitudinal outcome data and between-group comparisons were used for descriptive analyses. Forty-eight patients were randomised resistance training (RTG) (n=23) or control group (CG) (n=25). The RTG demonstrated improved outcomes for the functional domain of the Burn Specific Health Scale-Brief (p=0.017) and the Quick Disability of Arm Shoulder and Hand (p<0.001). Between group differences were seen for C-reactive protein and retinol binding protein (p=0.001). Total quality of life scores, lower limb disability, muscle strength and volume were not seen to be different between groups (p>0.05). Resistance training in addition to usual rehabilitation therapy showed evidence of improving functional outcomes, particularly in upper limb burn injuries. Additionally, resistance training commenced acutely after a burn injury was not seen to be harmful to patients.",2021,Between group differences were seen for C-reactive protein and retinol binding protein (p=0.001).,"['upper limb burn injuries', 'adults with a burn injury', 'Forty-eight patients were randomised', 'adults with acute burn injury']","['resistance training (RTG', 'Resistance training', 'standard physiotherapy, four weeks of high intensity resistance training (RTG) or sham resistance training (CG', 'control group (CG) ', 'resistance training']","['Total quality of life scores, lower limb disability, muscle strength and volume', 'quality of life plus a number of physical, functional and safety outcomes', 'functional outcomes', 'Quality of life', 'C-reactive protein and retinol binding protein', 'Quick Disability of Arm Shoulder and Hand', 'functional domain of the Burn Specific Health Scale-Brief']","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0035342', 'cui_str': 'Retinol binding protein'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]",48.0,0.124138,Between group differences were seen for C-reactive protein and retinol binding protein (p=0.001).,"[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Gittings', 'Affiliation': 'State Adult Burns Service, South Metropolitan Area Health Service, Fiona Stanley Hospital, Murdoch, Western Australia, Australia; School of Physiotherapy, University of Notre Dame Australia, Fremantle, Western Australia, Australia; Fiona Wood Foundation, Murdoch, Western Australia, Australia. Electronic address: paul.gittings@health.wa.gov.au.'}, {'ForeName': 'Benedict M', 'Initials': 'BM', 'LastName': 'Wand', 'Affiliation': 'School of Physiotherapy, University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Hince', 'Affiliation': 'Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Grisbrook', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Wood', 'Affiliation': 'State Adult Burns Service, South Metropolitan Area Health Service, Fiona Stanley Hospital, Murdoch, Western Australia, Australia; Fiona Wood Foundation, Murdoch, Western Australia, Australia; Burn Injury Research Unit, School of Medicine and Pharmacology, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Edgar', 'Affiliation': 'State Adult Burns Service, South Metropolitan Area Health Service, Fiona Stanley Hospital, Murdoch, Western Australia, Australia; Fiona Wood Foundation, Murdoch, Western Australia, Australia; Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia; Burn Injury Research Unit, School of Medicine and Pharmacology, University of Western Australia, Crawley, Western Australia, Australia; Burn Injury Research Node, Institute of Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.03.015']
373,33305542,"Efficacy and safety of guanfacine extended-release in Japanese adults with attention-deficit/hyperactivity disorder: Exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study.","AIM


Previously, we reported on the efficacy and safety of guanfacine extended-release (GXR) in Japanese adults with attention-deficit/hyperactivity disorder (ADHD) from a phase 3, double-blind, placebo-controlled, randomized trial. In this exploratory post hoc analysis, we assessed the efficacy and/or safety of GXR in the following subgroups: ADHD-combined (ADHD-C) and ADHD-predominantly inattentive (ADHD-I) subtypes, age (≥31, <31 years), sex (male, female), and body weight (≥50, <50 kg).
METHODS


The primary efficacy endpoint was change from baseline in the Japanese version of the investigator-rated ADHD-Rating Scale-IV (ADHD-RS-IV) with adult prompts (total scores) at week 10.
RESULTS


The efficacy analysis population included 200 patients (GXR, 100; placebo, 100). ADHD-RS-IV total score effect sizes (GXR vs placebo) were similar across all subgroups (total population: 0.52, ADHD-C: 0.51, ADHD-I: 0.52, ≥31 years: 0.61, <31 years: 0.47, male: 0.50, female: 0.57). There were no major differences in the incidence/types of treatment-emergent adverse events (TEAEs) across the subgroups. The incidence of significant TEAEs (34.3%, 10.6%) and TEAEs leading to discontinuation (34.3%, 12.1%) were approximately three times higher in females than males, respectively. The incidence of TEAEs in patients weighing <50 kg and ≥50 kg was 100% and 73.6% during dose optimization and 40% and 24.4% during the maintenance period, respectively.
CONCLUSION


Findings from this post hoc analysis in adults with ADHD support the efficacy and safety of GXR regardless of ADHD subtype, age, or sex and suggest that careful monitoring for TEAEs and GXR dose optimization is considered for all patients, as needed.",2021,There were no major differences in the incidence/types of treatment-emergent adverse events (TEAEs) across the subgroups.,"['Japanese adults with attention-deficit/hyperactivity disorder (ADHD', 'adults with ADHD', 'Japanese adults with attention-deficit/hyperactivity disorder', 'subgroups: ADHD-combined (ADHD-C) and ADHD-predominantly inattentive (ADHD-I) subtypes, age (≥31, <31\xa0years), sex (male, female), and body weight (≥50, <50\xa0kg', '200 patients (GXR, 100; placebo, 100', '0.52, ≥31\xa0years: 0.61, <31\xa0years: 0.47, male: 0.50, female: 0.57']","['placebo', 'guanfacine extended-release (GXR', 'GXR vs placebo', 'guanfacine']","['incidence/types of treatment-emergent adverse events (TEAEs', 'ADHD-RS-IV total score effect sizes', 'incidence of TEAEs', 'efficacy and/or safety of GXR', 'Efficacy and safety', 'efficacy and safety', 'Japanese version of the investigator-rated ADHD-Rating Scale-IV (ADHD-RS-IV) with adult prompts (total scores']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",200.0,0.478096,There were no major differences in the incidence/types of treatment-emergent adverse events (TEAEs) across the subgroups.,"[{'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Naya', 'Affiliation': 'Medical Affairs Department, Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Sakai', 'Affiliation': 'Medical Affairs Department, Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Okutsu', 'Affiliation': 'Clinical Research Department, Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kiguchi', 'Affiliation': 'Data Science Office, Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Fujiwara', 'Affiliation': 'Data Science Office, Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Toshinaga', 'Initials': 'T', 'LastName': 'Tsuji', 'Affiliation': 'Medical Affairs Department, Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Iwanami', 'Affiliation': 'Department of Psychiatry, Showa University, School of Medicine, Tokyo, Japan.'}]",Neuropsychopharmacology reports,['10.1002/npr2.12152']
374,33307218,"Geographic Atrophy Growth Is Strongly Related to Lesion Perimeter: Unifying Effects of Lesion Area, Number, and Circularity on Growth.","PURPOSE


To investigate the underlying reason for the previously observed impact of baseline lesion size, number, and circularity on geographic atrophy (GA) growth rate.
DESIGN


Retrospective analysis of a multicenter, prospective, randomized controlled trial.
PARTICIPANTS


Age-Related Eye Disease Study participants with GA secondary to nonexudative age-related macular degeneration.
METHODS


We manually delineated atrophic lesions on color fundus photographs of 318 eyes with GA followed up over at least 2 visits (mean follow-up duration, 5.1 ± 3.0 years). We calculated GA area growth rate for each eye based on the first and last visit. GA perimeter-adjusted growth rate was defined as the ratio between GA area growth rate and mean GA perimeter between the first and last visit for each eye.
MAIN OUTCOME MEASURES


GA area growth rate, growth rate of the square root of GA area, and GA perimeter-adjusted growth rate.
RESULTS


GA area growth rate was correlated strongly with mean GA perimeter (r 2  = 0.66). GA area growth rate was associated with baseline GA area (r 2  = 0.39; P < 0.001), lesion number (r 2  = 0.10; P < 0.001), and circularity index (r 2  = 0.28; P < 0.001). The use of the square root of GA area reduced the influence of baseline GA area (but not lesion number or circularity) on GA growth rate. In comparison, GA perimeter-adjusted growth rate (0.098 ± 0.062 mm/year) was not correlated with baseline GA area (r 2  = 0.005; P = 0.20), lesion number (r 2  = 0.00009; P = 0.86), or circularity index (r 2  = 0.007; P = 0.14). GA perimeter-adjusted growth rate was 50.0% higher in eyes whose fellow eyes showed GA at any visit (0.102 ± 0.062 mm/year) than in eyes whose fellow eyes never demonstrated GA during follow-up (0.068 ± 0.049 mm/year).
CONCLUSIONS


The growth rate of GA area is associated strongly with lesion perimeter. This relationship explains the previously observed influences of baseline GA size, lesion number, and circularity on GA growth rate. GA perimeter-adjusted growth rate is uncorrelated with the 3 morphologic factors and may serve as a surrogate outcome measure to monitor GA progression in future studies.",2021,"GA area growth rate was associated with baseline GA area (r 2  = 0.39, P < 0.001), lesion number (r 2  = 0.10, P < 0.001), and circularity index (r 2  = 0.28, P < 0.001).",['Age-Related Eye Disease Study (AREDS) participants with GA secondary to nonexudative age-related macular degeneration'],[],"['mean GA perimeter', 'baseline GA size, lesion number, and circularity on GA growth rate', 'lesion number', 'GA perimeter-adjusted growth rate', 'Lesion Area, Number, and Circularity on Growth', 'growth rate of GA area', 'GA growth rate', 'geographic atrophy (GA) growth rate', 'GA area growth rate, growth rate of square root of GA area, and GA perimeter-adjusted growth rate', 'GA area growth rate', 'circularity index']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0271083', 'cui_str': 'Nonexudative age-related macular degeneration'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449791', 'cui_str': 'Number of lesions'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",318.0,0.0672707,"GA area growth rate was associated with baseline GA area (r 2  = 0.39, P < 0.001), lesion number (r 2  = 0.10, P < 0.001), and circularity index (r 2  = 0.28, P < 0.001).","[{'ForeName': 'Liangbo L', 'Initials': 'LL', 'LastName': 'Shen', 'Affiliation': 'Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Molecular Biophysics and Biochemistry, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Aneesha', 'Initials': 'A', 'LastName': 'Ahluwalia', 'Affiliation': 'Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Young', 'Affiliation': 'Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Lucian V', 'Initials': 'LV', 'LastName': 'Del Priore', 'Affiliation': 'Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, Connecticut. Electronic address: lucian.delpriore@yale.edu.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.12.002']
375,33309410,Spot Urine Samples to Estimate Na and K Intake in Patients With Chronic Kidney Disease and Healthy Adults: A Secondary Analysis From a Controlled Feeding Study.,"OBJECTIVE


The objective of this study was to assess the agreement between estimated 24-hour urinary sodium excretion (e24hUNa) and estimated 24-hour urinary potassium excretion (e24hUK), calculated from a spot urine sample using several available equations and actual sodium and potassium intake from a controlled diet in both healthy participants and those with chronic kidney disease (CKD).
DESIGN AND METHODS


This study is a secondary analysis of a controlled feeding study in CKD patients matched to healthy controls. Participants (n = 16) consumed the controlled diet, which provided ∼2400 mg Na/day and ∼3000 mg K/day, for 8 days. On days 7 and 8, participants consumed all meals and collected all urine in an inpatient research setting, and they were discharged on day 9. The day 7 morning spot urine sample was used to calculate e24hUNa and e24hUK, which was compared with known sodium and potassium intake, respectively.
RESULTS


Average e24hUNa from the INTERSALT and Tanaka-Na equations were higher than actual sodium intake by 373 mg and 559 mg, respectively, though the differences were not significant. e24hUNa from the Nerbass-SALTED equation in CKD participants was significantly higher than actual sodium intake by ∼2000 mg (P < .001), though e24hUNa from the Nerbass-RRID equation was not different from intake. e24hUK from the Tanaka-K equation was significantly lower than actual potassium intake (P < .001). For both e24hUNa and e24hUK for all participants, agreement with actual intake was poor, and e24hUNa and e24hUK were not correlated with actual sodium or potassium intake, respectively.
CONCLUSION


e24hUNa and e24hUK are poor indicators of true sodium and potassium intake, respectively, in both healthy and CKD participants. Findings should be confirmed in larger sample sizes with varying levels of dietary sodium and potassium.",2021,e24hUK from the Tanaka-K equation was significantly lower than actual potassium intake (P < .001).,"['Patients With Chronic Kidney Disease and Healthy Adults', 'healthy participants and those with chronic kidney disease (CKD', 'CKD patients matched to healthy controls']","['controlled diet, which provided ∼2400\xa0mg']",['24-hour urinary sodium excretion (e24hUNa) and estimated 24-hour urinary potassium excretion (e24hUK'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]",,0.0330423,e24hUK from the Tanaka-K equation was significantly lower than actual potassium intake (P < .001).,"[{'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Lobene', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN; Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: alobene@udel.edu.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Stremke', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN; Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'McCabe', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Moe', 'Affiliation': 'Department of Medicine/Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ranjani N', 'Initials': 'RN', 'LastName': 'Moorthi', 'Affiliation': 'Department of Medicine/Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hill Gallant', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN; Department of Food Science and Nutrition, University of Minnesota, Minneapolis, MN.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2020.09.007']
376,33319347,Immersive virtual reality and antigravity treadmill training for gait rehabilitation in Parkinson's disease: a pilot and feasibility study.,"INTRODUCTION


Treadmill training is considered an effective intervention to improve gait ability in patients with Parkinson's disease (PD). In parallel, virtual reality shows promising intervention with several applications in the inpatient medical setting.
AIM


To evaluate the feasibility and preliminary efficacy of mechanical gait assistance combined with immersive virtual reality in patients with PD.
PATIENTS AND METHODS


This pilot and feasibility study followed a pre-post study design. The intervention consisted of 12 sessions of 30 minutes, distributed regularly over four consecutive weeks. Participants walked on a treadmill with a body-weight support system set at approximately 20% of body weight and equipped with a virtual reality helmet controlled by a two-handed joystick. Feasibility and intervention outcomes were collected at baseline and after four weeks of intervention.
RESULTS


Twelve participants of 60 patients were finally enrolled. Nine of them (75%) completed the treatment intervention with an adherence rate of 97%. Two participants left the study, one of them due to sickness associated with virtual reality and another because of a lack of motivation. There were significant differences associated with small-medium effect sizes when comparing the pre and post values for walk distance, walk speed, balance, and quality of life.
CONCLUSIONS


The present study provided preliminary evidence supporting the feasibility of the combination of antigravity treadmill and immersive virtual reality system for the rehabilitation of patients with PD.",2020,"There were significant differences associated with small-medium effect sizes when comparing the pre and post values for walk distance, walk speed, balance, and quality of life.
","[""Parkinson's disease"", 'patients with PD', ""patients with Parkinson's disease (PD"", 'Twelve participants of 60 patients were finally enrolled']","['treadmill with a body-weight support system set at approximately 20% of body weight and equipped with a virtual reality helmet controlled by a two-handed joystick', 'Immersive virtual reality and antigravity treadmill training', 'Treadmill training', 'antigravity treadmill and immersive virtual reality system', 'mechanical gait assistance combined with immersive virtual reality']","['adherence rate', 'gait ability', 'walk distance, walk speed, balance, and quality of life', 'small-medium effect sizes']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0748877', 'cui_str': 'Social Support System'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",60.0,0.0488001,"There were significant differences associated with small-medium effect sizes when comparing the pre and post values for walk distance, walk speed, balance, and quality of life.
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Brandín-De la Cruz', 'Affiliation': 'Universidad de San Jorge, Villanueva de Gállego, España.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Secorro', 'Affiliation': 'Universidad de San Jorge, Villanueva de Gállego, España.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Calvo', 'Affiliation': 'Universidad de San Jorge, Villanueva de Gállego, España.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Benyoucef', 'Affiliation': 'SPACEMEDEX, Valbonne Sophia-Antipolis, Francia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'Universidad de Zaragoza, 50013 Zaragoza, España.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bellosta-López', 'Affiliation': 'Universidad de San Jorge, Villanueva de Gállego, España.'}]",Revista de neurologia,['10.33588/rn.7112.2020352']
377,33308122,Clinical Study of Qingpeng Ointment Treating Shoulder-hand Syndrome After Cerebral Hemorrhage During the Rehabilitation Period.,"BACKGROUND


Shoulder-hand syndrome (SHS) refers to a syndrome causing sudden edema, shoulder pain and limited hand function. Qingpeng ointment, a kind of Tibetan medicine, can reduce swelling, relieve pain, tonify stagnation and clear the meridians, which is consistent with the pathological mechanism of SHS after stroke. Therefore, if clinical trials can be used to explore the effectiveness of Qingpeng ointment for the treatment of poststroke SHS and promote its application in clinical medicine, it may prove the specific significance for the treatment of poststroke SHS poststroke SHS.
OBJECTIVE


The aim of the study was to investigate the clinical efficacy and safety of Qingpeng ointment in the treatment of poststroke SHS and to provide an objective basis for a better therapeutic treatment for poststroke SHS.
METHODS


A prospective, randomized, controlled study was conducted. This study recruited 120 patients with poststroke SHS who met the inclusion criteria. They were randomized into the treatment group and the control group, with 60 patients allocated to each group. The treatment group received routine medical treatment and rehabilitative care after using the Qingpeng ointment, while the patients in the control group received only routine treatment without the ointment. All patients received clinical assessment with the Visual Analogue Scale (VAS), measurement of the range of motion (ROM) of the upper-limb joints, the Fugl-Meyer Assessment of Upper Extremity (FMA-U) and the Modified Barthel Index Score (MBI) before and after the whole treatment.
RESULTS


After 4 weeks of treatment, the VAS scores of both the groups decreased significantly (P ＜0.05), and the difference between the two groups was statistically significant (P < 0.05). No statistical significance was observed for the difference between the treatment group and control group in terms of the FMA-U and MBI scores and the forward bend, backward, outstretch, external rotation and pronation angles after treatment. The increases in the values of VAS, FMA-M and MBI in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). The increases in the values of the forward bend, outreach and external rotation angles in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05).
CONCLUSION


The treatment group showed better results than the control group in terms of the relief of pain symptoms, the improvement of motor function and the improvement of the activities of daily living for patients with shoulder-hand syndrome after cerebral hemorrhage. Qingpeng ointment was found to be effective and safe for treating poststroke SHS.",2021,"The treatment group showed better results than the control group in terms of the relief of pain symptoms, the improvement of motor function and the improvement of the activities of daily living for patients with shoulder-hand syndrome after cerebral hemorrhage.","['120 patients with poststroke SHS who met the inclusion criteria', 'Shoulder-Hand Syndrome']","['Qingpeng ointment', 'control group received only routine treatment without the ointment', 'routine medical treatment and rehabilitative care after using the Qingpeng ointment']","['values of the forward bend, outreach and external rotation angles', 'values of VAS, FMA-M and MBI', 'motor function', 'FMA-U and MBI scores and the forward bend, backward, outstretch, external rotation and pronation angles', 'clinical efficacy and safety', 'VAS scores', 'relief of pain symptoms', 'activities of daily living', 'Visual Analogue Scale (VAS), measurement of the range of motion (ROM) of the upper-limb joints, the Fugl-Meyer Assessment of Upper Extremity (FMA-U) and the Modified Barthel Index Score (MBI']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034931', 'cui_str': 'Complex regional pain syndrome type I'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1562117', 'cui_str': 'Forward bending'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0033421', 'cui_str': 'Pronation'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",120.0,0.022253,"The treatment group showed better results than the control group in terms of the relief of pain symptoms, the improvement of motor function and the improvement of the activities of daily living for patients with shoulder-hand syndrome after cerebral hemorrhage.","[{'ForeName': 'Ruihuan', 'Initials': 'R', 'LastName': 'Pan', 'Affiliation': 'Department of Rehabilitation, The 2nd affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Ling', 'Affiliation': 'Department of Rehabilitation, The 2nd affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Haodong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'The Second Institute of Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'The Second Institute of Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Lechang', 'Initials': 'L', 'LastName': 'Zhan', 'Affiliation': 'Department of Rehabilitation, The 2nd affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'The Second Institute of Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation, The 2nd affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Combinatorial chemistry & high throughput screening,['10.2174/1386207323666201211093227']
378,33316435,A randomized trial of aerobic exercise in chronic kidney disease: Evidence for blunted cardiopulmonary adaptations.,"BACKGROUND


Patients with chronic kidney disease have reduced cardiorespiratory fitness levels that contribute to mortality.
OBJECTIVES


The purpose of this study was to investigate the effects of aerobic exercise on cardiopulmonary function in patients with chronic kidney disease.
METHODS


A total of 36 patients (mean [SD] estimated glomerular filtration rate 44 [12] ml/min/1.73m 2 ) were randomly allocated to an exercise training or a control arm over 12 weeks. The exercise training group performed aerobic exercise for 45min 3 times/week at 65% to 80% heart rate reserve. The control group received routine care. Outcome measures were assessed at baseline and 12 weeks. Cardiopulmonary exercise testing was performed on a cycle ergometer with workload increased by 15W/min. A battery of physical function tests were administered. Habitual physical activity levels were recorded via accelerometry. Data are mean [SD].
RESULTS


Exercise training improved VO 2peak  as compared with the control group (exercise: 17.89 [4.18] vs 19.98 [5.49]; control: 18.29 [6.49] vs 17.36 [5.99] ml/kg/min; P<0.01). Relative O 2  pulse improved following exercise, suggestive of improved left ventricular function (exercise: 0.12 [0.02] vs 0.14 [0.04]; control: 0.14 [0.05] vs 0.14 [0.04] ml/beat/kg; P=0.03). Ventilation perfusion mismatching (V E /VCO2) remained evident after exercise (exercise: 32 [5] vs 33 [5]; control: 32 [7] vs 34 [5] AU; P=0.1). Exercise did not affect the ventilatory cost of oxygen uptake (V E /VO 2 ; exercise: 40 [7] vs 42 [8]; control: 3 [7] vs 41 [8] AU; P=0.5) and had no effect on autonomic function assessed by maximal and recovery heart rates. We found no changes in physical function or habitual physical activity levels.
CONCLUSIONS


Cardiopulmonary adaptations appeared to be attenuated in patients with chronic kidney disease and were not fully restored to levels observed in healthy individuals. Improvements in exercise capacity did not confer benefits to physical function. Interventions coupled with exercise may be required to enhance adaptations in chronic kidney disease. Performed according to CONSORT guidelines; ClinicalTrials.gov: NCT02050035.",2021,"RESULTS


Exercise training improved VO2peak as compared with the control group (exercise: 17.89 [4.18] vs 19.98 [5.49]; control: 18.29 [6.49] vs 17.36 [5.99] ml/kg/min; p<0.01).","['patients with chronic kidney disease', 'chronic kidney disease', 'Patients with chronic kidney disease', '36 patients (mean [SD] estimated glomerular filtration rate 44 [12] ml/min/1.73m2']","['exercise training group performed aerobic exercise', 'routine care', 'exercise training', 'aerobic exercise', 'Exercise training']","['physical function or habitual physical activity levels', 'Relative O2 pulse improved following exercise, suggestive of improved left ventricular function', 'cardiopulmonary function', 'Habitual physical activity levels', 'autonomic function assessed by maximal and recovery heart rates', 'Ventilation perfusion mismatching (VE/VCO2', 'ventilatory cost of oxygen uptake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",36.0,0.0380349,"RESULTS


Exercise training improved VO2peak as compared with the control group (exercise: 17.89 [4.18] vs 19.98 [5.49]; control: 18.29 [6.49] vs 17.36 [5.99] ml/kg/min; p<0.01).","[{'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Kirkman', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, 201Q Health Sciences Complex, 540 S. College Ave, Newark, DE, 19716, USA; Department of Kinesiology and Health Sciences, Virginia Commonwealth University, Richmond, VA, USA. Electronic address: dlkirkman@vcu.edu.'}, {'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Ramick', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, 201Q Health Sciences Complex, 540 S. College Ave, Newark, DE, 19716, USA; Department of Kinesiology, West Chester University, West Chester, PA, USA. Electronic address: mramick@wcupa.edu.'}, {'ForeName': 'Bryce J', 'Initials': 'BJ', 'LastName': 'Muth', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, 201Q Health Sciences Complex, 540 S. College Ave, Newark, DE, 19716, USA; School of Health Sciences, Stockton University, Galloway, NJ, USA. Electronic address: bryce.muth@stockton.edu.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Stock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, 201Q Health Sciences Complex, 540 S. College Ave, Newark, DE, 19716, USA. Electronic address: jmstock@udel.edu.'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Pennsylvania, PA, USA. Electronic address: townsend@upenn.edu.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, 201Q Health Sciences Complex, 540 S. College Ave, Newark, DE, 19716, USA. Electronic address: dge@udel.edu.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.101469']
379,33321089,Multimodal Prehabilitation for Lung Cancer Surgery: A Randomized Controlled Trial.,"BACKGROUND


The study was conducted to determine whether a multimodal prehabilitation program enhances postoperative functional recovery compared with multimodal rehabilitation.
METHODS


Patients scheduled for non-small cell lung cancer resection were randomized to 2 groups receiving home-based moderate-intensity exercise, nutritional counseling with whey protein supplementation, and anxiety-reducing strategies for 4 weeks before the operation (PREHAB, n = 52) or 8 weeks after (REHAB, n = 43). Functional capacity (FC) was measured by the 6-minute walk test (6MWT) at baseline, immediately before the operation, and 4 and 8 weeks after operation. All patients were treated according to enhanced recovery pathway guidelines.
RESULTS


There was no difference in FC at any point during the perioperative period between the 2 multimodal programs. By 8 weeks after operation, both groups returned to baseline FC, and a similar proportion of patients (>75%) in both groups had recovered to their baseline.
CONCLUSIONS


In patients undergoing surgical resection for lung cancer within the context of an enhanced recovery pathway, multimodal prehabilitation initiated 4 weeks before operation is as effective in recovering FC as multimodal rehabilitation.",2021,There was no difference in FC at any time point during the perioperative period between the two multimodal programs.,"['Patients scheduled for non-small cell lung cancer resection', 'patients undergoing surgical resection for lung cancer', 'Lung Cancer Surgery']","['home-based moderate intensity exercise, nutritional counseling with whey protein supplementation and anxiety reducing strategies']","['Functional capacity (FC', 'FC']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",,0.0697775,There was no difference in FC at any time point during the perioperative period between the two multimodal programs.,"[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Ferreira', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, Quebec, Canada; Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Enrico Maria', 'Initials': 'EM', 'LastName': 'Minnella', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Rashami', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Gamsa', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Ferri', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mulder', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sirois', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Spicer', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: franco.carli@mcgill.ca.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.11.022']
380,33331495,Acceptance and commitment therapy-based behavioral intervention for insomnia: a pilot randomized controlled trial.,"OBJECTIVE


To evaluate a protocol for acceptance and commitment therapy-based behavioral intervention for insomnia (ACT-BBI-I) in adults compared to cognitive behavioral therapy for insomnia (CBT-I).
METHODS


Forty-five adults with chronic insomnia were randomized to ACT-BBI-I or CBT-I. Both interventions were performed in six weekly group sessions. The common treatment elements in both protocols included stimulus control and sleep restriction. CBT-I is focused on the cognitive restructuring of maladaptive beliefs about sleep and the daytime effects of insomnia. ACT-BBI-I focuses on therapeutic processes of acceptance, availability, values, defusion, and commitment. The results were evaluated through the following instruments: a sleep diary, the Insomnia Severity Index, the Epworth Sleepiness Scale, the Hospital Anxiety and Depression Scale, the Acceptance and Action Questionnaire-II, and the Dysfunctional Beliefs and Attitudes about Sleep scale.
RESULTS


Both interventions had a significant positive impact on sleep patterns, insomnia, anxiety, beliefs about sleep, and psychological flexibility. All improvement was maintained at the 6-month follow-up.
CONCLUSION


The results suggest that integrating principles of ACT with behavioral techniques may be useful for treating insomnia. Further research should identify whether the principles of ACT result in added effectiveness compared to behavioral components alone.
CLINICAL TRIAL REGISTRATION


RBR-7nc5wq.",2020,"The results were evaluated through the following instruments: a sleep diary, the Insomnia Severity Index, the Epworth Sleepiness Scale, the Hospital Anxiety and Depression Scale, the Acceptance and Action Questionnaire-II, and the Dysfunctional Beliefs and Attitudes about Sleep scale.
","['Forty-five adults with chronic insomnia', 'insomnia']","['commitment therapy-based behavioral intervention', 'cognitive behavioral therapy', 'Acceptance and commitment therapy-based behavioral intervention', 'ACT-BBI-I or CBT-I']","['sleep diary, the Insomnia Severity Index, the Epworth Sleepiness Scale, the Hospital Anxiety and Depression Scale, the Acceptance and Action Questionnaire-II, and the Dysfunctional Beliefs and Attitudes about Sleep scale', 'stimulus control and sleep restriction', 'sleep patterns, insomnia, anxiety, beliefs about sleep, and psychological flexibility', 'acceptance, availability, values, defusion, and commitment', 'ACT-BBI']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0871436', 'cui_str': 'Stimulus control'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]",45.0,0.0607636,"The results were evaluated through the following instruments: a sleep diary, the Insomnia Severity Index, the Epworth Sleepiness Scale, the Hospital Anxiety and Depression Scale, the Acceptance and Action Questionnaire-II, and the Dysfunctional Beliefs and Attitudes about Sleep scale.
","[{'ForeName': 'Renatha', 'Initials': 'R', 'LastName': 'El Rafihi-Ferreira', 'Affiliation': 'Ambulatório de Sono, Instituto de Psiquiatria, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'École de Psychologie, Université Laval, Sainte-Foy, Québec, Canada.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Toscanini', 'Affiliation': 'Ambulatório de Sono, Instituto de Psiquiatria, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lotufo Neto', 'Affiliation': 'Instituto de Psiquiatria, Hospital das Clínicas, Faculdade de Medicina, USP, São Paulo, SP, Brazil.'}, {'ForeName': 'Israel S', 'Initials': 'IS', 'LastName': 'Brasil', 'Affiliation': 'Ambulatório de Sono, Instituto de Psiquiatria, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'João G', 'Initials': 'JG', 'LastName': 'Gallinaro', 'Affiliation': 'Ambulatório de Sono, Instituto de Psiquiatria, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Daniel Suzuki', 'Initials': 'DS', 'LastName': 'Borges', 'Affiliation': 'Ambulatório de Sono, Instituto de Psiquiatria, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Silvia G', 'Initials': 'SG', 'LastName': 'Conway', 'Affiliation': 'Ambulatório de Sono, Instituto de Psiquiatria, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Hasan', 'Affiliation': 'Ambulatório de Sono, Instituto de Psiquiatria, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2020-0947']
381,33323326,Effects of Intensive Individualized Nutrition Counseling on Nutritional Status and Kidney Function in Patients With Stage 3 and 4 Chronic Kidney Disease.,"OBJECTIVE


Although dietary modification is a critical component of chronic kidney disease (CKD) management, compliance with dietary recommendations is often suboptimal. This prospective intervention study was conducted to evaluate the effects and adherence of intensive, individualized nutrition counseling in CKD patients from a single nation Asian ethnic group.
METHODS


Patients with Stages 3 and 4 CKD were recruited from a tertiary hospital outpatient clinic in Korea. The intensive group received 3 monthly sessions of individualized intensive nutrition counseling. The control group received a one-time group program. The intensive group was compared with the control group at 3 months.
RESULTS


A total of 59 patients were enrolled, and 42 (71.2%) completed the study (23/32 of the intensive group; 19/27 of the control group). The mean age of the patients was 64.7 ± 12.5 years, and 81% were male. The most common nutritional diagnosis was an excessive intake of sodium (Na, 97.6%), followed by potassium (K, 78.6%), protein (52.4%), and phosphorus (P, 31.0%). After 3 months of nutrition counseling, K and P intakes decreased significantly in both the intensive group (K, 2,760.9 ± 677.4 vs. 1,500.7 ± 398.5 mg/d, P < .001; P, 1,010.5 ± 247.4 vs. 631.3 ± 178.1 mg/d, P < .001) and the control group (K, 2,090.8 ± 765.3 vs. 1,703.9 ± 490.0 mg/d, P = .036; P, 807.2 ± 163.8 vs. 679.1 ± 175.9 mg/d, P = .044). Meanwhile, protein (68.3 ± 21.8 vs. 45.4 ± 10.1 g/d, P = .001), Na (4,009.8 ± 1,418.2 vs. 2,224.6 ± 759.8 mg/d, P < .001), and energy intakes (1,857.1 ± 411.5 vs. 1,273.7 ± 231.5 kcal, P < .001) decreased in the intensive group, but were comparable in the control group. Notably, BMI decreased (BMI, 25.4 ± 2.5 vs. 24.9 ± 2.9 kg/m2, P = .014) while eGFR (43.1 ± 11.8 vs. 48.9 ± 13.7 mL/min/1.73m2, P = .002) improved significantly in the intensive group only.
CONCLUSION


Intensive individualized nutrition counseling results in better adherence to dietary recommendations and improvement in kidney function in CKD patients.",2021,"Notably, BMI decreased (BMI, 25.4 ± 2.5 vs. 24.9 ± 2.9 kg/m2, P = .014) while eGFR (43.1 ± 11.8 vs. 48.9 ± 13.7 mL/min/1.73m2, P = .002) improved significantly in the intensive group only.
","['CKD patients from a single nation Asian ethnic group', 'A total of 59 patients were enrolled, and 42 (71.2%) completed the study (23/32 of the intensive group; 19/27 of the control group', 'Patients with Stages 3 and 4 CKD were recruited from a tertiary hospital outpatient clinic in Korea', 'The mean age of the patients was 64.7 ± 12.5 years, and 81% were male', 'CKD patients', 'Patients With Stage 3 and 4 Chronic Kidney Disease']","['individualized intensive nutrition counseling', 'intensive, individualized nutrition counseling', 'Intensive Individualized Nutrition Counseling']","['K and P intakes', 'BMI', 'energy intakes', 'Nutritional Status and Kidney Function', 'kidney function']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1282531', 'cui_str': 'Asian - ethnic group'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",59.0,0.0230609,"Notably, BMI decreased (BMI, 25.4 ± 2.5 vs. 24.9 ± 2.9 kg/m2, P = .014) while eGFR (43.1 ± 11.8 vs. 48.9 ± 13.7 mL/min/1.73m2, P = .002) improved significantly in the intensive group only.
","[{'ForeName': 'Hosun', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Nutrition Care, Severance Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Hyun Ha', 'Initials': 'HH', 'LastName': 'Park', 'Affiliation': 'Department of Nutrition Care, Severance Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'In-Young', 'Initials': 'IY', 'LastName': 'Jo', 'Affiliation': 'Department of Nutrition Care, Severance Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Jong Hyun', 'Initials': 'JH', 'LastName': 'Jhee', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Institute of Kidney Disease Research, Yonsei University, Seoul, Korea; Division of Nephrology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung Tak', 'Initials': 'JT', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Institute of Kidney Disease Research, Yonsei University, Seoul, Korea. Electronic address: JTPARK@yuhs.ac.'}, {'ForeName': 'Song Mi', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Nutrition Care, Severance Hospital, Yonsei University Health System, Seoul, Korea. Electronic address: nutrpine@yuhs.ac.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2020.10.001']
382,33371995,Patient Satisfaction of Propofol Versus Midazolam and Fentanyl Sedation During Colonoscopy in Inflammatory Bowel Disease.,"BACKGROUND & AIMS


Colonoscopy is essential for optimal management of inflammatory bowel disease. However, many patients opt out due to unpleasantness related to this procedure. We investigated if Nurse Administered Propofol Sedation (NAPS) would improve patient satisfaction and attitude towards future colonoscopies.
METHODS


Randomized clinical trial of deep sedation with NAPS (n = 63) versus moderate midazolam and fentanyl sedation (n = 67). To assess the primary end point of patient satisfaction at discharge, we developed a Satisfaction Questionnaire comprising 13 items each rated by a 5-point Likert scale and with higher scores reflecting more positive outcomes (13-65 points).
RESULTS


Fifty-six patients (43%) with ulcerative colitis, 48 (37%) with Crohn's disease, and 26 (20%) with high suspicion of inflammatory bowel disease were included. Most (88%) had previously had a colonoscopy and pre-procedure expectations were similar between groups. Patients receiving deep sedation had significantly higher satisfaction score (mean 60.1, SD 3.4) than those receiving moderate sedation (51.2, 8.4; P < .001). This was driven especially by less pain, more amnesia, sedation more to their liking, and better experience with the current than previous sedations. Importantly, these patients significantly more often preferred the same sedation for a future colonoscopy and were also inclined to accept more frequent colonoscopies. Assistance from another colonoscopist and disruption of the procedure due to pain occurred significantly more frequent in the moderate sedation group. There were no safety signals associated with NAPS.
CONCLUSIONS


Patients with inflammatory bowel disease favor deep propofol sedation over moderate midazolam and fentanyl sedation. Availability of NAPS may facilitate patient adherence to endoscopy-based monitoring programs. Clinicaltrials.gov NCT01934088.",2020,Assistance from another colonoscopist and disruption of the procedure due to pain occurred significantly more frequent in the moderate sedation group.,"['Patients with IBD favor deep propofol sedation over moderate midazolam and fentanyl sedation', 'n=67', ""Fifty-six patients (43%) with ulcerative colitis, 48 (37%) with Crohn's disease, and 26 (20%) with high suspicion of IBD were included""]","['deep sedation with NAPS', 'midazolam and fentanyl sedation', 'Propofol Versus Midazolam and Fentanyl Sedation', 'NAPS', 'Propofol Sedation (NAPS']","['satisfaction score', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0745336,Assistance from another colonoscopist and disruption of the procedure due to pain occurred significantly more frequent in the moderate sedation group.,"[{'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Steenholdt', 'Affiliation': 'Department of Gastroenterology, Herlev-Gentofte University Hospital, Herlev, Denmark. Electronic address: steenholdt@dadlnet.dk.'}, {'ForeName': 'Jeppe T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Gastroenterology, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Brynskov', 'Affiliation': 'Department of Gastroenterology, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Ann Merete', 'Initials': 'AM', 'LastName': 'Møller', 'Affiliation': 'Department of Anaesthesiology, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Anne Christine', 'Initials': 'AC', 'LastName': 'Limschou', 'Affiliation': 'Department of Gastroenterology, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Konge', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation, University of Copenhagen and the Capital Region of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vilmann', 'Affiliation': 'Department of Gastroenterology, Herlev-Gentofte University Hospital, Herlev, Denmark.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.10.037']
383,33368969,"Endoxifen: A new, protein kinase C inhibitor to treat acute and mixed mania associated with bipolar I disorder.","OBJECTIVES


Endoxifen is a protein kinase C inhibitor. The objective of the present phase III study was to demonstrate the safety and efficacy of endoxifen in treating bipolar I disorder (BPD I) patients.
METHODS


A multicenter, double-blind, active-controlled study was conducted using a daily dose of 8 mg endoxifen compared to 1000 mg divalproex, the current standard treatment, in patients with BPD I acute manic episodes with/without mixed features. The primary endpoint of our study was the mean change in total Young Mania Rating Scale (YMRS) score at day 21.
RESULTS


Endoxifen (n = 116) significantly (p < 0.0001) reduced total YMRS score (from 33.1 to 17.8. A significant (p < 0.001) improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) score was observed for endoxifen (4.8 to 2.5). Early time to remission of the disease was observed with endoxifen compared to divalproex. None of the patients required rescue medication and there was no drug-associated withdrawals. Changes in Clinical Global Impressions-Bipolar Disorder and Clinical Global Impression-Severity of Illness scores showed that treatment with endoxifen was well-tolerated.
CONCLUSIONS


Endoxifen at a low daily dose of 8 mg was as efficacious and safe in patients with BPD I acute manic episodes with/without mixed features.",2021,"RESULTS


Endoxifen (n=116) significantly (P < 0.0001) reduced total YMRS score (from 33.1 to 17.8.","['bipolar I disorder (BPD I) patients', 'patients with BPD']","['divalproex', 'Endoxifen', 'Protein Kinase C inhibitor', 'endoxifen']","['safety and efficacy', 'Clinical Global Impressions-Bipolar Disorder and Clinical Global Impression-Severity of Illness scores', 'total Young Mania Rating Scale (YMRS) score', 'Montgomery-Åsberg Depression Rating Scale (MADRS) score', 'total YMRS score']","[{'cui': 'C0853193', 'cui_str': 'Bipolar I disorder'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0048311', 'cui_str': '4-hydroxy-N-desmethyltamoxifen'}, {'cui': 'C0033634', 'cui_str': 'Protein kinase C'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",,0.0654107,"RESULTS


Endoxifen (n=116) significantly (P < 0.0001) reduced total YMRS score (from 33.1 to 17.8.","[{'ForeName': 'Ateeq', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'Jina Pharmaceuticals Inc, Libertyville, IL, USA.'}, {'ForeName': 'Saifuddin', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Jina Pharmaceuticals Inc, Libertyville, IL, USA.'}, {'ForeName': 'Mujtaba Ali', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Intas Pharmaceuticals Ltd, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Chaturvedi', 'Affiliation': 'Intas Pharmaceuticals Ltd, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Piyush', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Intas Pharmaceuticals Ltd, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Lambda Therapeutic Research Ltd, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Bakul Chandrakant', 'Initials': 'BC', 'LastName': 'Buch', 'Affiliation': 'Shri Hatkesh Healthcare Foundation, Junagadh, Gujarat, India.'}, {'ForeName': 'Rajendra Someshwar', 'Initials': 'RS', 'LastName': 'Anand', 'Affiliation': 'Kanoria Hospital and Research Centre, Gandhinagar, Gujarat, India.'}, {'ForeName': 'Timirkumar Chandrakant', 'Initials': 'TC', 'LastName': 'Shah', 'Affiliation': 'Divyam Hospital, Surat, Gujarat, India.'}, {'ForeName': 'Vaishal Nareshchandra', 'Initials': 'VN', 'LastName': 'Vora', 'Affiliation': 'Ratandeep Multispecialty Hospital, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Vikhram', 'Initials': 'V', 'LastName': 'Ramasubramanian', 'Affiliation': 'Ahana Hospitals, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Satyanarayana', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'JSS Medical College Hospital, Mysore, Karnataka, India.'}, {'ForeName': 'Narendra', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Mysore Medical College and Research Institute, K.R. Hospital, Mysore, Karnataka, India.'}, {'ForeName': 'B S V', 'Initials': 'BSV', 'LastName': 'Prasad', 'Affiliation': 'Sujata Birla Hospital and Medical Research Center, Nasik, Maharashtra, India.'}, {'ForeName': 'Ramanathan', 'Initials': 'R', 'LastName': 'Sathianathan', 'Affiliation': 'Sri Ramachandra Medical College and Research Institute, Chennai Tamil Nadu, India.'}, {'ForeName': 'Kamal Kumar', 'Initials': 'KK', 'LastName': 'Verma', 'Affiliation': 'S.P. Medical College and A.G. Hospitals, Bikaner, Rajasthan, India.'}, {'ForeName': 'Venu Gopal', 'Initials': 'VG', 'LastName': 'Jhanwar', 'Affiliation': 'Deva Institute of Healthcare and Research, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Nand', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Gujarat Medical Education & Research Society Medical College, Gotri, Vadodara, India.'}, {'ForeName': 'Pronob Kumar', 'Initials': 'PK', 'LastName': 'Dalal', 'Affiliation': ""King George's Medical University, G.M. Associated Hospitals, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Brahmdeep', 'Initials': 'B', 'LastName': 'Sindhu', 'Affiliation': 'Civil Hospital, Gurugram, Haryana, India.'}, {'ForeName': 'Payel', 'Initials': 'P', 'LastName': 'Talukdar', 'Affiliation': 'Nil Ratan Sircar Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Jina Pharmaceuticals Inc, Libertyville, IL, USA.'}]",Bipolar disorders,['10.1111/bdi.13041']
384,33318891,An online randomized trial of healthy default beverages and unhealthy beverage restrictions on children's menus.,"Several U.S. jurisdictions have adopted policies requiring healthy beverage defaults on children's menus, but it is unknown whether such policies or restrictions leads to fewer calories ordered. We recruited 479 caregivers of children for an online choice experiment and instructed participants to order dinner for their youngest child (2-6 years) from two restaurant menus. Participants were randomly assigned to one type of menu: 1) standard beverages on children's menus ( Control ; n = 155); 2) healthy beverages on children's menus (water, milk, or 100% juice), with unhealthy beverages available as substitutions ( Default ; n = 162); or 3) healthy beverages on children's menus, with no unhealthy beverage substitutions ( Restriction ; n = 162). We used linear regression with bootstrapping to examine differences between conditions in calories ordered from beverages. Secondary outcomes included percent of participants ordering unhealthy beverages (full-calorie soda, diet soda, and/or sugar-sweetened fruit drinks) and calories from unhealthy beverages. Calories ordered from beverages did not differ across conditions at Chili's [ Default : 97.6 (SD = 69.8); p = 0.82;  Restriction : 102.7 (SD = 71.5); p = 0.99;  Control : 99.4 (SD = 72.7)] or McDonald's [ Default : 90.2 (SD = 89.1); p = 0.55;  Restriction : 89.0 (SD = 81.0); p = 0.94;  Control : 96.5 (SD = 95.2)]. There were no differences in the percent of orders or calories ordered from unhealthy beverages. Though  Restriction  participants ordered fewer calories from full-calorie soda [(3.0 (SD = 21.6)] relative to  Control  participants [13.4 (SD = 52.1); p = 0.04)] at Chili's, we observed no such difference between  Default  and  Control  participants, or across McDonald's conditions. Overall, there was no effect of healthy default beverages or restrictions in reducing total calories ordered from unhealthy beverages for children in our experiment.",2020,"Overall, there was no effect of healthy default beverages or restrictions in reducing total calories ordered from unhealthy beverages for children in our experiment.","[""children's menus"", '479 caregivers of children for an online choice experiment and instructed participants to order dinner for their youngest child (2-6\xa0years) from two restaurant menus']","[""standard beverages on children's menus ( Control ; n\xa0=\xa0155); 2) healthy beverages on children's menus (water, milk, or 100% juice), with unhealthy beverages available as substitutions ( Default ; n\xa0=\xa0162); or 3) healthy beverages on children's menus, with no unhealthy beverage substitutions"", 'healthy default beverages and unhealthy beverage restrictions']","['total calories', 'calories from full-calorie soda', 'percent of participants ordering unhealthy beverages (full-calorie soda, diet soda, and/or sugar-sweetened fruit drinks) and calories from unhealthy beverages']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0683086', 'cui_str': 'Caffeinated soft drinks'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",479.0,0.0818071,"Overall, there was no effect of healthy default beverages or restrictions in reducing total calories ordered from unhealthy beverages for children in our experiment.","[{'ForeName': 'Pasquale E', 'Initials': 'PE', 'LastName': 'Rummo', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, United States.'}, {'ForeName': 'Alyssa J', 'Initials': 'AJ', 'LastName': 'Moran', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Aviva A', 'Initials': 'AA', 'LastName': 'Musicus', 'Affiliation': 'Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, United States.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Roberto', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bragg', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, United States.'}]",Preventive medicine reports,['10.1016/j.pmedr.2020.101279']
385,33370142,Gratitude reduces consumption of depleting resources.,"Sustaining finite public resources presents a dilemma between acting in self-interest for present benefit versus working toward long-term collective gain. Given gratitude's links to prosociality and self-control, the present studies investigated whether gratitude would promote sustainable resource extraction under conditions of rapidly depleting resources. In Study 1 (N = 155), participants were randomly assigned to experience an emotional state (gratitude or neutral) prior to playing a resource dilemma game in which the common pool was manipulated to indicate either a sustained or depleting resource status. Neutral participants increased their point taking when the pool was depleting compared with when it was sustained; however, this pattern was not observed for grateful participants. Study 2 (N = 224) replicated these findings while also showing the effect of gratitude to be distinct from happiness. These findings show that gratitude, as opposed to a general positive emotional state, buffers against overtaking in resource dilemmas and suggests that this emotion may be useful in promoting sustainable behavior. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"These findings show that gratitude, as opposed to a general positive emotional state, buffers against overtaking in resource dilemmas and suggests that this emotion may be useful in promoting sustainable behavior.",[],['emotional state (gratitude or neutral) prior to playing a resource dilemma game'],[],[],"[{'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",[],,0.0528222,"These findings show that gratitude, as opposed to a general positive emotional state, buffers against overtaking in resource dilemmas and suggests that this emotion may be useful in promoting sustainable behavior.","[{'ForeName': 'Shanyu', 'Initials': 'S', 'LastName': 'Kates', 'Affiliation': 'Department of Psychology, Northeastern University.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'DeSteno', 'Affiliation': 'Department of Psychology, Northeastern University.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000936']
386,33337797,Rapid Sequence Induction With a Standard Intubation Dose of Rocuronium After Magnesium Pretreatment Compared With Succinylcholine: A Randomized Clinical Trial.,"BACKGROUND


Succinylcholine remains the muscle relaxant of choice for rapid sequence induction (RSI) but has many adverse effects. High-dose rocuronium bromide may be an alternative to succinylcholine for RSI but recovery times are nearly doubled compared with a standard intubating dose of rocuronium. Magnesium sulfate significantly shortens the onset time of a standard intubating dose of rocuronium. We set out to investigate whether intravenous (IV) pretreatment with MgSO4 followed by a standard intubating dose of rocuronium achieved superior intubation conditions compared with succinylcholine.
METHODS


Adults were randomized to receive a 15-minute IV infusion of MgSO4 (60 mg·kg-1) immediately before RSI with propofol 2 mg·kg-1, sufentanil 0.2 μg·kg-1 and rocuronium 0.6 mg·kg-1, or a matching 15-minute IV infusion of saline immediately before an identical RSI, but with succinylcholine 1 mg·kg-1. Primary end point was the rate of excellent intubating conditions 60 seconds after administration of the neuromuscular blocking agent and compared between groups using multivariable log-binomial regression model. Secondary end points were blood pressure and heart rate before induction, before and after intubation, and adverse events up to 24 hours postoperatively.
RESULTS


Among 280 randomized patients, intubating conditions could be analyzed in 259 (133 MgSO4-rocuronium and 126 saline-succinylcholine). The rate of excellent intubating conditions was 46% with MgSO4-rocuronium and 45% with saline-succinylcholine. The analysis adjusted for gender and center showed no superiority of MgSO4-rocuronium compared with saline-succinylcholine (relative risk [RR] 1.06, 95% confidence interval [CI], 0.81-1.39, P = .659). The rate of excellent intubating conditions was higher in women (54% [70 of 130]) compared with men (37% [48 of 129]; adjusted RR 1.42, 95% CI, 1.07-1.91, P = .017). No significant difference between groups was observed for systolic and diastolic blood pressures. Mean heart rate was significantly higher in the MgSO4-rocuronium group. The percentage of patients with at least 1 adverse event was lower with MgSO4-rocuronium (11%) compared with saline-succinylcholine (28%) (RR 0.38, 95% CI, 0.22-0.66, P < .001). With saline-succinylcholine, adverse events consisted mainly of postoperative muscle pain (n = 26 [19%]) and signs of histamine release (n = 13 [9%]). With MgSO4-rocuronium, few patients had pain on injection, nausea and vomiting, or skin rash during the MgSO4-infusion (n = 5 [4%]).
CONCLUSIONS


IV pretreatment with MgSO4 followed by a standard intubating dose of rocuronium did not provide superior intubation conditions to succinylcholine but had fewer adverse effects.",2020,"The percentage of patients with at least 1 adverse event was lower with MgSO4-rocuronium (11%) compared with saline-succinylcholine (28%) (RR 0.38, 95% CI, 0.22-0.66, P < .001).","['280 randomized patients, intubating conditions could be analyzed in 259 (133', 'Adults']","['rocuronium', 'Magnesium sulfate', 'succinylcholine 1 mg·kg-1', 'Magnesium', 'propofol 2 mg·kg-1, sufentanil 0.2 μg·kg-1 and rocuronium 0.6 mg·kg-1, or a matching 15-minute IV infusion of saline', 'saline-succinylcholine', 'rocuronium bromide', 'MgSO4-rocuronium and 126 saline-succinylcholine', 'intravenous (IV) pretreatment with MgSO4', 'Succinylcholine', 'succinylcholine', 'MgSO4', 'Rocuronium']","['signs of histamine release', 'pain on injection, nausea and vomiting, or skin rash', 'Mean heart rate', 'systolic and diastolic blood pressures', 'blood pressure and heart rate before induction, before and after intubation, and adverse events', 'rate of excellent intubating conditions', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0038627', 'cui_str': 'Succinylcholine'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0069632', 'cui_str': 'rocuronium bromide'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0019595', 'cui_str': 'Histamine Liberation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",280.0,0.819938,"The percentage of patients with at least 1 adverse event was lower with MgSO4-rocuronium (11%) compared with saline-succinylcholine (28%) (RR 0.38, 95% CI, 0.22-0.66, P < .001).","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Czarnetzki', 'Affiliation': 'From the Division of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Albrecht', 'Affiliation': 'Department of Anesthesiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Masouyé', 'Affiliation': 'From the Division of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Baeriswyl', 'Affiliation': 'Department of Anesthesiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Poncet', 'Affiliation': 'Clinical Research Centre & Division of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva & Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Robin', 'Affiliation': 'From the Division of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kern', 'Affiliation': 'Department of Anesthesiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Tramèr', 'Affiliation': 'From the Division of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005324']
387,33343761,Feasibility of a Smartphone App with Mindfulness Training for Adolescent Smoking Cessation: Craving to Quit (C2Q)-Teen.,"Objectives


The use of mobile technology for smoking cessation holds promise for adolescents, who do not typically access traditional treatments, but most are not grounded in theory or mechanism. Operant conditioning theory suggests an addictive smoking loop is formed between nicotine use and affective states, leading to habitual cue-induced craving and automatic behavior; mindfulness training may bring automated smoking behavior into awareness, so smokers may work mindfully with cravings. Mindfulness training delivered via smartphone technology therefore has potential to help adolescent smokers break this addictive loop and quit smoking. This pair-matched cluster-randomized controlled school-based pilot study evaluated program feasibility and preliminary smoking outcomes in relation to intervention engagement.
Methods


Six high schools were pair matched and randomly assigned to one of three interventions: (1) mindfulness training delivered via mobile smoking cessation application (Craving to Quit, C2Q), (2) NCI's QuitSTART smoking cessation application (NCI), and (3) written cessation materials (Materials). Adolescents (n = 146) smoking 5 or more cigarettes per day were recruited. Interventions were implemented over four weeks and study assessments were collected at baseline and 3- and 6- month follow-up, including self-reported 7-day point prevalence abstinence, program usage, smoking-related measures, and psychosocial factors.
Results


Overall cotinine-validated abstinence at 6 months was 15.8% and was similar between conditions. Odds of abstinence increased with each quartile increase in app/materials use with no significant differences between conditions (OR=1.60 (C2Q), 1.66 (Materials), and 2.69 (NCI)). Of participants still smoking at 6 months, for each quartile increase in engagement the number of cigarettes smoked in the previous 7 days showed a significantly greater decline in the C2Q condition (-5.71) compared to the Materials (-0.95) and NCI (+7.73) condition (p=0.02 for differences between conditions).
Conclusions


Cotinine-validated abstinence was similar between intervention conditions and tended to increase with greater engagement in each condition. Greater C2Q app engagement among continuing smokers was associated with a significantly greater decline in number of cigarettes smoked compared to the other conditions. The Craving to Quit (C2Q) mobile smoking cessation application with mindfulness training was feasible to use and has promise in assisting adolescents to quit or decrease cigarette smoking.
Clinical Trial Registration


Developing a Smartphone App with Mindfulness Training for Teen Smoking Cessation: ClinicalTrials.gov Identifier: NCT02218281.",2020,"Odds of abstinence increased with each quartile increase in app/materials use with no significant differences between conditions (OR=1.60 (C2Q), 1.66 (Materials), and 2.69 (NCI)).","['Adolescent Smoking Cessation', 'Teen Smoking Cessation', 'Adolescents (n = 146) smoking 5 or more cigarettes per day were recruited']","['Smartphone App with Mindfulness Training', 'mobile technology for smoking cessation', ""mindfulness training delivered via mobile smoking cessation application (Craving to Quit, C2Q), (2) NCI's QuitSTART smoking cessation application (NCI), and (3) written cessation materials (Materials"", 'mindfulness training', 'Mindfulness training delivered via smartphone technology']","['Overall cotinine-validated abstinence', 'Odds of abstinence', 'number of cigarettes smoked', 'C2Q condition']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",146.0,0.0153051,"Odds of abstinence increased with each quartile increase in app/materials use with no significant differences between conditions (OR=1.60 (C2Q), 1.66 (Materials), and 2.69 (NCI)).","[{'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Pbert', 'Affiliation': 'Division of Preventive and Behavioral Medicine, 368 Plantation Street, University of Massachusetts Medical School, Worcester, MA USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Druker', 'Affiliation': 'Division of Preventive and Behavioral Medicine, 368 Plantation Street, University of Massachusetts Medical School, Worcester, MA USA.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': 'Graduate School of Nursing, 55 Lake Avenue North, University of Massachusetts Medical School, Worcester, MA USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Frisard', 'Affiliation': 'Division of Preventive and Behavioral Medicine, 368 Plantation Street, University of Massachusetts Medical School, Worcester, MA USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Division of Pediatric Pulmonology, University of Massachusetts Medical School, Worcester, MA USA.'}, {'ForeName': 'Stavroula K', 'Initials': 'SK', 'LastName': 'Osganian', 'Affiliation': ""Division of General Pediatrics, Department of Medicine, Children's Hospital, Boston Children's Hospital, 300 Longwood Ave, Boston, MA USA.""}, {'ForeName': 'Judson', 'Initials': 'J', 'LastName': 'Brewer', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health, RI USA.'}]",Mindfulness,['10.1007/s12671-019-01273-w']
388,33359556,Descemet Endothelial Thickness Comparison Trial: Two-Year Results from a Randomized Trial Comparing Ultrathin Descemet Stripping Automated Endothelial Keratoplasty with Descemet Membrane Endothelial Keratoplasty.,,2021,,[],['Ultrathin Descemet Stripping Automated Endothelial Keratoplasty'],[],[],"[{'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}]",[],,0.0433905,,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rose-Nussbaumer', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Byers Eye Institute, Stanford University, Palo Alto, California.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Zijun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jameson', 'Initials': 'J', 'LastName': 'Clover', 'Affiliation': 'Lions VisionGift, Portland, Oregon.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'McLeod', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Departmet of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Departmet of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Dresner', 'Affiliation': 'Cornea Image Analysis Reading Center, University Hospitals Eye Institute and Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': 'Benetz', 'Affiliation': 'Cornea Image Analysis Reading Center, University Hospitals Eye Institute and Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Lass', 'Affiliation': 'Cornea Image Analysis Reading Center, University Hospitals Eye Institute and Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Winston D', 'Initials': 'WD', 'LastName': 'Chamberlain', 'Affiliation': 'Casey Eye Institute, Oregon Health & Science University, Portland, Oregon. Electronic address: chamberw@ohsu.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2020.12.021']
389,33373715,Spectral Domain OCT Predictors of Visual Acuity in the Study of COmparative Treatments for REtinal Vein Occlusion 2: SCORE 2 Report 15.,"PURPOSE


To evaluate the association between baseline demographic and spectral domain OCT (SD-OCT) features with visual acuity (VA) in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) over 2 years.
DESIGN


Post hoc analysis of prospective clinical trial data.
PARTICIPANTS


A total of 362 SCORE2 participants with macular edema secondary to central retinal (CRVO) or hemiretinal vein occlusion (HRVO).
METHODS


Spectral domain OCT volume scans were assessed at the SCORE2 reading center at baseline, month 01 (M01), month 06 (M06), month 12 (M12), and month 24 (M24) for central subfield thickness (CST), subretinal fluid, intraretinal fluid, vitreoretinal interface abnormalities, disorganization of retinal inner layers (DRIL), and ellipsoid zone (EZ) within the central subfield (CSF).
MAIN OUTCOME MEASURES


Visual acuity at M06, M12, and M24.
RESULTS


Mean baseline age was 68.9 years. Mean VA at M01 was 63.2 letters, and CST was 299.7 μm. At M01, subretinal fluid was seen in 28.5% intraretinal fluid in 67.2%, DRIL was seen in 73.8%, mostly within the CSF, and the EZ was absent in 9.8 and patchy in 31.7%. In multivariate analysis including all M01 demographics and SD-OCT parameters and their association with VA at M06, M12, and M24, VA at M01 remained significant across all time points up to M24 (P < 0.001).
CONCLUSIONS


In this 2-year follow-up of eyes that were treated with both per protocol and off protocol for RVO, VA at M01 was an important predictor of long-term vision and change in vision. Establishing predictors of visual recovery helps identify causes for poor responders to treatment in patients with RVO.",2021,"At M01, subretinal fluid was seen in 28.5% intraretinal fluid in 67.2%, DRIL was seen in 73.8%, mostly within CSF and EZ was absent in 9.8 and patchy in 31.7%.","['patients with RVO', 'REtinal Vein Occlusion 2 (SCORE2) over 2 years', '362 SCORE2 participants with macular edema secondary to central retinal (CRVO) or hemi-retinal vein occlusion (HRVO']",[],"['central subfield thickness (CST), subretinal fluid, intraretinal fluid, vitreoretinal interface abnormalities, disorganization of retinal inner layers (DRIL), and ellipsoid zone (EZ) within the central subfield (CSF', 'DRIL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035328', 'cui_str': 'Retinal vein occlusion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}]",[],"[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}]",362.0,0.19349,"At M01, subretinal fluid was seen in 28.5% intraretinal fluid in 67.2%, DRIL was seen in 73.8%, mostly within CSF and EZ was absent in 9.8 and patchy in 31.7%.","[{'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Etheridge', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Blodi', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Oden', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Veldhuisen', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland.'}, {'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ip', 'Affiliation': 'Doheny Eye Institute, University of California Los Angeles Stein Eye Institute, Los Angeles, California.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Mititelu', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Amitha', 'Initials': 'A', 'LastName': 'Domalpally', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. Electronic address: domalpally@wisc.edu.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.12.016']
390,33332582,The efficacy and mechanisms of a guided self-help intervention based on mindfulness in patients with breast cancer: A randomized controlled trial.,"BACKGROUND


Mindfulness-based interventions (MBIs) can alleviate psychological distress in patients with cancer. However, face-to-face MBIs may be inconvenient for patients. Therefore, guided self-help interventions may be more accessible. The authors investigated the effects of a guided self-help MBI for depression, anxiety, and sleep disorder symptoms in patients with breast cancer and explored the potential underlying mechanisms.
METHODS


One hundred forty-four postoperative patients with breast cancer were randomly assigned to an intervention group (6-week guided self-help MBI; n = 72) or a wait-list control group (routine treatment; n = 72). Self-reported depression, anxiety, sleep disorder symptoms, and rumination and worry as potential mediators were assessed at baseline and postintervention. Outcomes were then assessed at 1-month and 3-month follow-up. The intervention's effects over time and the potential mediating effect were analyzed using generalized estimating equations. The trial was registered at the Chinese Clinical Registry (ChiCTR-IOR-16008073).
RESULTS


Significant improvements in depression and sleep disorder symptoms occurred in the intervention group compared with wait-list controls, and the improvements were maintained at 1-month and 3-month follow-up. Changes in rumination and worry mediated the intervention's effects on changes in depression and sleep disorder symptoms.
CONCLUSIONS


A guided self-help MBI reduced depressive and sleep disorder symptoms by mitigating rumination and worry in patients with breast cancer. These findings support benefits of this accessible psychological intervention in oncology and provide insight into possible mechanisms of action. The current research contributes to discovering effective and widely accessible means for people with physical health conditions and may remove barriers that otherwise would have precluded participation in face-to-face psychological interventions.",2021,"RESULTS


Significant improvements in depression and sleep disorder symptoms occurred in the intervention group compared with wait-list controls, and the improvements were maintained at 1-month and 3-month follow-up.","['patients with cancer', 'people with physical health conditions', 'patients with breast cancer', 'One hundred forty-four postoperative patients with breast cancer']","['intervention group (6-week guided self-help MBI; n = 72) or a wait-list control', 'guided self-help intervention', 'Mindfulness-based interventions (MBIs', 'guided self-help MBI']","['depression and sleep disorder symptoms', 'depressive and sleep disorder symptoms', 'Self-reported depression, anxiety, sleep disorder symptoms, and rumination and worry as potential mediators', 'depression, anxiety, and sleep disorder symptoms', 'psychological distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",144.0,0.0412409,"RESULTS


Significant improvements in depression and sleep disorder symptoms occurred in the intervention group compared with wait-list controls, and the improvements were maintained at 1-month and 3-month follow-up.","[{'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Shao', 'Affiliation': 'Center for Health Management and Policy, School of Public Health, National Health Commission Key Laboratory of Health Economics and Policy, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Naixue', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'School of Nursing, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Jiwei', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'School of Nursing, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Center for Health Management and Policy, School of Public Health, National Health Commission Key Laboratory of Health Economics and Policy, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Fenglin', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'School of Nursing, Cheeloo College of Medicine, Shandong University, Jinan, China.'}]",Cancer,['10.1002/cncr.33381']
391,33359303,Association between Baseline Cortisol Serum Concentrations and the Effect of Prophylactic Hydrocortisone in Extremely Preterm Infants.,"OBJECTIVE


To define nomograms of serum cortisol values before 24 hours of postnatal life for extremely preterm infants and determine whether baseline cortisol values affect the benefit/risk ratio of prophylactic hydrocortisone to improve survival without bronchopulmonary dysplasia (BPD).
STUDY DESIGN


We performed a predefined secondary analysis of the multicenter randomized controlled PREMILOC trial that included inborn infants delivered before 28 weeks of gestation. Nomograms of baseline serum cortisol values measured in 325 enrolled patients were determined for male and female neonates and correlated to perinatal events. BPD-free survival and severe adverse events were analyzed in placebo and hydrocortisone groups according to the cortisol z score in multivariate logistic regression models.
RESULTS


Increased cortisol levels measured before 24 hours following birth were associated with a significantly higher chance of BPD-free survival only in placebo-treated infants (aOR [95% CI] 1.57 [1.08-2.27], P = .02) based on sex-specific nomograms for baseline cortisol levels. The cortisol z score for infants treated with prophylactic hydrocortisone predicted a risk of high-grade intraventricular hemorrhage (aOR [95% CI] 1.82 [1.06-3.15], P = .03) and spontaneous intestinal perforation (aOR [95% CI] 4.81 [1.34-17.22], P = .02).
CONCLUSIONS


We found no predictive value of baseline cortisol levels for BPD-free survival in infants born extremely preterm treated with hydrocortisone. However, high cortisol levels early after birth were associated with a greater risk of severe intraventricular hemorrhage and spontaneous intestinal perforation in infants treated with hydrocortisone and, therefore, a lower benefit/risk ratio for the treatment.
TRIAL REGISTRATION


EudraCT 2007-002041-20, ClinicalTrial.gov: NCT00623740.",2021,"RESULTS


Increased cortisol levels measured before 24 hours following birth were associated with a significantly higher chance of BPD-free survival only in placebo-treated infants (aOR [95%CI]: 1.57 1.08 - 2.27], p = 0.02) based on sex-specific nomograms for baseline cortisol levels.","['Extremely Preterm Infants', '325 enrolled patients were determined for male and female neonates and correlated to perinatal events', 'extremely preterm infants', 'included inborn infants delivered before 28 weeks of gestation']","['prophylactic hydrocortisone', 'Prophylactic Hydrocortisone']","['BPD-free survival and severe adverse events', 'survival without bronchopulmonary dysplasia (BPD', 'severe intraventricular hemorrhage and spontaneous intestinal perforation', 'BPD-free survival', 'risk of high-grade intraventricular hemorrhage', 'baseline serum cortisol values', 'cortisol z-score', 'serum cortisol values', 'cortisol levels', 'spontaneous intestinal perforation']","[{'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]","[{'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0021845', 'cui_str': 'Perforation of intestine'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",325.0,0.515047,"RESULTS


Increased cortisol levels measured before 24 hours following birth were associated with a significantly higher chance of BPD-free survival only in placebo-treated infants (aOR [95%CI]: 1.57 1.08 - 2.27], p = 0.02) based on sex-specific nomograms for baseline cortisol levels.","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Renolleau', 'Affiliation': 'Neonatal Intensive Care Unit, Assistance Publique-Hôpitaux de Paris, CHU Robert Debré, University Paris Diderot, Sorbone Paris Cité, Paris, France.'}, {'ForeName': 'Artemis', 'Initials': 'A', 'LastName': 'Toumazi', 'Affiliation': 'Unit of Clinical Epidemiology, Assistance Publique-Hôpitaux de Paris, CHU Robert Debré, University Paris Diderot, Sorbonne Paris-Cité, Inserm U1123 and CIC-EC 1426, Paris, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Bourmaud', 'Affiliation': 'Unit of Clinical Epidemiology, Assistance Publique-Hôpitaux de Paris, CHU Robert Debré, University Paris Diderot, Sorbonne Paris-Cité, Inserm U1123 and CIC-EC 1426, Paris, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Benoist', 'Affiliation': 'Department of Biochemistry and Hormonology, Assistance Publique-Hôpitaux de Paris, CHU Robert Debré, University Paris Diderot, Sorbone Paris Cité, Paris, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Chevenne', 'Affiliation': 'Department of Biochemistry and Hormonology, Assistance Publique-Hôpitaux de Paris, CHU Robert Debré, University Paris Diderot, Sorbone Paris Cité, Paris, France.'}, {'ForeName': 'Damir', 'Initials': 'D', 'LastName': 'Mohamed', 'Affiliation': 'Unit of Clinical Epidemiology, Assistance Publique-Hôpitaux de Paris, CHU Robert Debré, University Paris Diderot, Sorbonne Paris-Cité, Inserm U1123 and CIC-EC 1426, Paris, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Alberti', 'Affiliation': 'Unit of Clinical Epidemiology, Assistance Publique-Hôpitaux de Paris, CHU Robert Debré, University Paris Diderot, Sorbonne Paris-Cité, Inserm U1123 and CIC-EC 1426, Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Biran', 'Affiliation': 'Neonatal Intensive Care Unit, Assistance Publique-Hôpitaux de Paris, CHU Robert Debré, University Paris Diderot, Sorbone Paris Cité, Paris, France; Inserm U1141, University Paris Diderot, Sorbone Paris Cité, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Baud', 'Affiliation': ""Inserm U1141, University Paris Diderot, Sorbone Paris Cité, Paris, France; Division of Neonatology and Pediatric Intensive Care, Children's University Hospital of Geneva and University of Geneva, Geneva, Switzerland. Electronic address: olivier.baud@hcuge.ch.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.12.057']
392,33382448,Effect of sodium bicarbonate supplementation on the renin-angiotensin system in patients with chronic kidney disease and acidosis: a randomized clinical trial.,"BACKGROUND


Acidosis-induced kidney injury is mediated by the intrarenal renin-angiotensin system, for which urinary renin is a potential marker. Therefore, we hypothesized that sodium bicarbonate supplementation reduces urinary renin excretion in patients with chronic kidney disease (CKD) and metabolic acidosis.
METHODS


Patients with CKD stage G4 and plasma bicarbonate 15-24 mmol/l were randomized to receive sodium bicarbonate (3 × 1000 mg/day, ~ 0.5 mEq/kg), sodium chloride (2 × 1,00 mg/day), or no treatment for 4 weeks (n = 15/arm). The effects on urinary renin excretion (primary outcome), other plasma and urine parameters of the renin-angiotensin system, endothelin-1, and proteinuria were analyzed.
RESULTS


Forty-five patients were included (62 ± 15 years, eGFR 21 ± 5 ml/min/1.73m 2 , plasma bicarbonate 21.7 ± 3.3 mmol/l). Sodium bicarbonate supplementation increased plasma bicarbonate (20.8 to 23.8 mmol/l) and reduced urinary ammonium excretion (15 to 8 mmol/day, both P < 0.05). Furthermore, a trend towards lower plasma aldosterone (291 to 204 ng/L, P = 0.07) and potassium (5.1 to 4.8 mmol/l, P = 0.06) was observed in patients receiving sodium bicarbonate. Sodium bicarbonate did not significantly change the urinary excretion of renin, angiotensinogen, aldosterone, endothelin-1, albumin, or α1-microglobulin. Sodium chloride supplementation reduced plasma renin (166 to 122 ng/L), and increased the urinary excretions of angiotensinogen, albumin, and α1-microglobulin (all P < 0.05).
CONCLUSIONS


Despite correction of acidosis and reduction in urinary ammonium excretion, sodium bicarbonate supplementation did not improve urinary markers of the renin-angiotensin system, endothelin-1, or proteinuria. Possible explanations include bicarbonate dose, short treatment time, or the inability of urinary renin to reflect intrarenal renin-angiotensin system activity.",2021,"Sodium bicarbonate did not significantly change the urinary excretion of renin, angiotensinogen, aldosterone, endothelin-1, albumin, or α1-microglobulin.","['Forty-five patients were included (62\u2009±\u200915\xa0years, eGFR 21\u2009±\u20095\xa0ml/min/1.73m 2 , plasma bicarbonate 21.7\u2009±\u20093.3\xa0mmol/l', 'patients with chronic kidney disease and acidosis', 'Patients with CKD stage G4 and plasma bicarbonate 15-24\xa0mmol', 'patients with chronic kidney disease (CKD) and metabolic acidosis']","['sodium chloride', 'sodium bicarbonate supplementation', 'Sodium chloride supplementation', 'Sodium bicarbonate supplementation', 'Sodium bicarbonate', 'sodium bicarbonate']","['urinary excretions of angiotensinogen, albumin, and α1-microglobulin', 'renin-angiotensin system', 'urinary renin excretion', 'urinary ammonium excretion', 'urinary excretion of renin, angiotensinogen, aldosterone, endothelin-1, albumin, or α1-microglobulin', 'plasma renin', 'plasma bicarbonate', 'potassium', 'urinary markers of the renin-angiotensin system, endothelin-1, or proteinuria', 'urinary renin excretion (primary outcome), other plasma and urine parameters of the renin-angiotensin system, endothelin-1, and proteinuria', 'plasma aldosterone']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0858075', 'cui_str': 'Plasma bicarbonate'}, {'cui': 'C5191366', 'cui_str': '21.7'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}]","[{'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0003017', 'cui_str': 'Angiotensinogen'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0858075', 'cui_str': 'Plasma bicarbonate'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}]",45.0,0.0260805,"Sodium bicarbonate did not significantly change the urinary excretion of renin, angiotensinogen, aldosterone, endothelin-1, albumin, or α1-microglobulin.","[{'ForeName': 'Dominique M', 'Initials': 'DM', 'LastName': 'Bovée', 'Affiliation': 'Divisions of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Room Ns403, PO Box 2040, 3000, CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Lodi C W', 'Initials': 'LCW', 'LastName': 'Roksnoer', 'Affiliation': 'Vascular Medicine and Pharmacology, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'van Kooten', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Joris I', 'Initials': 'JI', 'LastName': 'Rotmans', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Section of Nephrology, Department of Internal Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'de Borst', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zietse', 'Affiliation': 'Divisions of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Room Ns403, PO Box 2040, 3000, CA, Rotterdam, The Netherlands.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Vascular Medicine and Pharmacology, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Divisions of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Room Ns403, PO Box 2040, 3000, CA, Rotterdam, The Netherlands. e.j.hoorn@erasmusmc.nl.'}]",Journal of nephrology,['10.1007/s40620-020-00944-5']
393,33332191,Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study.,"PURPOSE


High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance  Bacillus Calmette-Guerin  (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible.
MATERIALS AND METHODS


We conducted a two-arm, prospective multicenter randomized study to determine the feasibility in  Bacillus Calmette-Guerin -naive patients. Participants had new high-risk HRNMIBC suitable for both treatments. Random assignment was stratified by age, sex, center, stage, presence of carcinoma in situ, and prior low-risk bladder cancer. Qualitative work investigated how to maintain equipoise. The primary outcome was the number of patients screened, eligible, recruited, and randomly assigned.
RESULTS


We screened 407 patients, approached 185, and obtained consent from 51 (27.6%) patients. Of these, one did not proceed and therefore 50 were randomly assigned (1:1). In the mBCG arm, 23/25 (92.0%) patients received mBCG, four had nonmuscle invasive bladder cancer (NMIBC) after induction, three had NMIBC at 4 months, and four received RC. At closure, two patients had metastatic BC. In the RC arm, 20 (80.0%) participants received cystectomy, including five (25.0%) with no tumor, 13 (65.0%) with HRNMIBC, and two (10.0%) with muscle invasion in their specimen. At follow-up, all patients in the RC arm were free of disease. Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC). The quality of life (QOL) of both arms was broadly similar at 12 months.
CONCLUSION


A randomized controlled trial comparing mBCG and RC will be challenging to recruit into. Around 10% of patients with high-risk HRNMIBC have a lethal disease and may be better treated by primary radical treatment. Conversely, many are suitable for bladder preservation and may maintain their prediagnosis QOL.",2021,Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC).,"['Bacillus Calmette-Guerin -naive patients', 'High-Risk High-Grade Nonmuscle Invasive Bladder Cancer', '407 patients, approached 185, and obtained consent from 51 (27.6%) patients']","['Radical Cystectomy Against Intravesical BCG', 'intravesical maintenance  Bacillus Calmette-Guerin  (mBCG) and radical cystectomy (RC', 'mBCG']","['metastatic BC', 'Adverse events', 'quality of life (QOL', 'nonmuscle invasive bladder cancer (NMIBC']","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C1532670', 'cui_str': 'Obtaining consent'}]","[{'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C1289970', 'cui_str': 'Intravesical BCG'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}]","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]",407.0,0.200624,Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC).,"[{'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gordon', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Collinson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Poad', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Twiddy', 'Affiliation': 'Institute of Clinical and Applied Health Research, University of Hull, Hull, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Freeman Hospital, Newcastle, United Kingdom.'}, {'ForeName': 'Sunjay', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Chahal', 'Affiliation': 'Bradford Teaching Hospitals NHS Foundation Trust, Bradford, United Kingdom.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Simms', 'Affiliation': 'Hull and East Yorkshire NHS Trust, Hull, United Kingdom.'}, {'ForeName': 'Mohantha', 'Initials': 'M', 'LastName': 'Dooldeniya', 'Affiliation': 'Mid Yorkshire Hospitals NHS Trust, Wakefield, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bell', 'Affiliation': 'Churchill Hospital, Oxford University Hospitals NHS Trust, Oxford, United Kingdom.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Koenig', 'Affiliation': 'Airedale NHS Foundation Trust, Keighley, United Kingdom.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Conroy', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Goodwin', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Aidan P', 'Initials': 'AP', 'LastName': 'Noon', 'Affiliation': 'Department of Urology, Royal Hallamshire Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Croft', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01665']
394,33350619,Effect of Different Positions During Surgical Preparation With Combined Spinal-Epidural Anesthesia for Elective Cesarean Delivery: A Randomized Controlled Trial.,"BACKGROUND


The intraoperative 15° left-tilt position during cesarean delivery has more recently been questioned regarding its effect on fetal acid-base balance and is a frequent source of complaints by surgeons. We hypothesized that a 30° left-tilt position during surgical preparation could improve the acid-base balance of the fetus compared with the 15° left-tilt or supine position during surgical preparation.
METHODS


Women undergoing elective cesarean delivery under combined spinal epidural anesthesia were randomized to a supine position, 15° left-lateral tilt position or 30° left-lateral tilt position; the position was changed to supine before the incision. Anesthetic management was standardized and included fluid loading with 10 mL/kg of normal saline followed by colloid loading. Hypotension (systolic blood pressure [SBP] reduction >20% baseline value or SBP <90 mm Hg) was treated with boluses of phenylephrine or ephedrine according to maternal heart rate. The primary outcome was umbilical arterial blood pH and the secondary outcomes included maternal SBP within 15 minutes after induction of anesthesia, the amount of vasoactive drug administered before end of the surgery, and the incidence of hypotension during cesarean delivery.
RESULTS


Seventy-five patients were included. After testing by analysis of variance, there was no significant difference in the umbilical arterial pH among the 3 groups (supine group: 7.31 ± 0.03 vs 15° group: 7.30 ± 0.04 vs 30° group: 7.31 ± 0.02, P = .28). The 30° group required significantly less phenylephrine (P = .007) and ephedrine (P = .005) before the end of surgery than the supine group; however, the only benefit observed in the 15° group was that the mean SBP at 3 minutes after spinal injection was significantly improved compared with the supine group.
CONCLUSIONS


Compared with the supine position, the 30° left-tilt position during surgical preparation did not significantly improve the fetal acid-base status, but it significantly reduced the use of phenylephrine and ephedrine and reduced the incidence of hypotension; however, these benefits were not observed in the 15° left-tilt group.",2021,"The 30° group required significantly less phenylephrine (P = .007) and ephedrine (P = .005) before the end of surgery than the supine group; however, the only benefit observed in the 15° group was that the mean SBP at 3 minutes after spinal injection was significantly improved compared with the supine group.
","['Seventy-five patients were included', 'Women undergoing elective cesarean delivery under combined spinal epidural anesthesia', 'Elective Cesarean Delivery']","['phenylephrine and ephedrine', 'Anesthetic management was standardized and included fluid loading with 10 mL/kg of normal saline followed by colloid loading', 'Different Positions During Surgical Preparation With Combined Spinal-Epidural Anesthesia', 'phenylephrine', 'SBP', 'ephedrine', 'phenylephrine or ephedrine', 'supine position, 15° left-lateral tilt position or 30° left-lateral tilt position; the position was changed to supine before the incision']","['incidence of hypotension', 'mean SBP', 'fetal acid-base status', 'umbilical arterial pH', 'umbilical arterial blood pH', 'Hypotension (systolic blood pressure [SBP', 'maternal SBP within 15 minutes after induction of anesthesia, the amount of vasoactive drug administered before end of the surgery, and the incidence of hypotension during cesarean delivery']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0033061', 'cui_str': 'Preoperative care'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C1532124', 'cui_str': 'Left lateral tilt'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",75.0,0.124144,"The 30° group required significantly less phenylephrine (P = .007) and ephedrine (P = .005) before the end of surgery than the supine group; however, the only benefit observed in the 15° group was that the mean SBP at 3 minutes after spinal injection was significantly improved compared with the supine group.
","[{'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'From the Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Shiya', 'Initials': 'S', 'LastName': 'Zou', 'Affiliation': 'From the Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'From the Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'From the Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'From the Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital.""}, {'ForeName': 'Xiuxiu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'From the Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Zeshu', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'From the Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'From the Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Hanbing', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'From the Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Dunyi', 'Initials': 'D', 'LastName': 'Qi', 'Affiliation': 'From the Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005320']
395,33358235,Impact of bone mineral density in reducing fracture risk in patients receiving alendronate plus alfacalcidol therapy.,"BACKGROUD


Changes in bone mineral density (BMD) are a potential surrogate marker for fracture endpoints in clinical trials. However little is known whether the increase in BMD in response to combination treatment with alendronate plus alfacalcidol is associated with fracture risk reduction. We aimed to evaluate the impact of BMD on fracture risk in osteoporosis patients, using the data from the randomized clinical trial comparing alendronate plus alfacalcidol with alendronate alone.
METHODS


We selected 412 patients with two or more prevalent vertebral fractures and who had BMD measurements at baseline and after 6, 12, and/or 24 months out of 2022 patients from the database of the Japanese Osteoporosis Intervention Trial. Patients in this subset who received combination treatment with alendronate plus alfacalcidol had shown a lower risk of fracture than patients treated with alendronate alone. We used Poisson regression model analysis to calculate the proportion of treatment effect (PTE) that was attributable to BMD increases in patients receiving combination treatment.
RESULTS


The highest PTE attributable to changes in BMD was 1.2% in patients with a BMD increase of 3% or more in the lumbar spine. For BMD measurements of the radius, the highest PTE was 2.8% with a BMD increase of 0% or more. For BMD measurements of the metacarpal bone, the highest PTE was 1.2% with a BMD increase of 3% or more. In patients with a BMD greater than or equal to 70% of the young adult mean in the lumbar spine, the PTE attributable to BMD was 0.2%. In patients with a BMD greater than or equal to 70% of the young adult mean in the radius, the PTE attributable to BMD was 0.3%.
CONCLUSIONS


The additional effects of alfacalcidol in reducing fracture risk do not likely result from increased BMD; other mechanisms remain a possibility.",2021,"For BMD measurements of the radius, the highest PTE was 2.8% with a BMD increase of 0% or more.","['patients receiving alendronate plus alfacalcidol therapy', 'patients receiving combination treatment', '412 patients with two or more prevalent vertebral fractures and who had BMD measurements at baseline and after 6, 12, and/or 24 months out of 2022 patients from the database of the Japanese Osteoporosis Intervention Trial', 'osteoporosis patients']","['alendronate plus alfacalcidol', 'alendronate', 'BMD', 'alendronate plus alfacalcidol with alendronate alone', 'alfacalcidol']","['fracture risk', 'risk of fracture', 'BMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0044410', 'cui_str': 'Alfacalcidol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0044410', 'cui_str': 'Alfacalcidol'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",2022.0,0.0525506,"For BMD measurements of the radius, the highest PTE was 2.8% with a BMD increase of 0% or more.","[{'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Itoi', 'Affiliation': 'Department of Orthopaedic Surgery, Tohoku University School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Division, Clinical Research Support Center, Tokyo University Hospital, Tokyo, Japan. Electronic address: yuemura@hosp.ncgm.go.jp.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ohta', 'Affiliation': 'Clinical Medical Center, International University of Health and Welfare, Tokyo, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Japan Osteoporosis Foundation, Tokyo, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Orimo', 'Affiliation': 'Japan Osteoporosis Foundation, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Department of Internal Medicine, Research Institute and Practice for Involutional Diseases, Nagano, Japan.'}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2020.10.017']
396,33387000,Dual Tasking Influences Cough Reflex Outcomes in Adults with Parkinson's Disease: A Controlled Study.,"Coughing is an essential airway protective reflex. In healthy young adults, cough somatosensation changes when attention is divided (dual tasking). Whether the same is true in populations at risk of aspiration remains unknown. We present findings from a controlled study testing the effects of divided attention (via a dual-task paradigm) on measures of reflex cough in Parkinson's disease. Volunteers with Parkinson's disease (n = 14, age = 43-79 years) and 14 age-matched controls underwent five blocks of capsaicin-induced cough challenges. Within each block, capsaicin ranging from 0 to 200 μM was presented in a randomized order. Two blocks consisted of cough testing only (single task), and two blocks consisted of cough testing with simultaneous tone counting (dual task). Finally, participants completed a suppressed cough task. Measures of cough motor response, self-reported urge to cough, cough frequency, and cough airflow were collected. Historical data from healthy young adults was included for comparison. Between-group analyses revealed no differences between single- and dual-cough-task responses. However, post hoc analysis revealed a significant relationship between dual-task errors and cough frequency that was strongest in people with Parkinson's disease [p = 0.004, r 2  = 0.52]. Specifically, greater errors were associated with fewer reflexive coughs. Unlike healthy participants, participants with Parkinson's disease did not change the number of coughs between the single-, dual-, and suppressed-task conditions [p > 0.05]. When distracted, people with Parkinson's disease may prioritize coughing differently than healthy controls. Abnormal cortical resource allocation may be a mechanism involved in aspiration in this population.",2021,"Unlike healthy participants, participants with Parkinson's disease did not change the number of coughs between the single-, dual-, and suppressed-task conditions [p > 0.05].","['healthy young adults', ""Adults with Parkinson's Disease"", ""Parkinson's disease"", ""Volunteers with Parkinson's disease (n\u2009=\u200914, age\u2009=\u200943-79\xa0years) and 14 age-matched controls underwent five blocks of""]","['capsaicin-induced cough challenges', 'Dual Tasking', 'divided attention (via a dual-task paradigm', 'cough testing only (single task), and two blocks consisted of cough testing with simultaneous tone counting (dual task', 'capsaicin']","['suppressed cough task', 'cough motor response, self-reported urge to cough, cough frequency, and cough airflow', 'single- and dual-cough-task responses', 'dual-task errors and cough frequency', 'reflex cough']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0589101', 'cui_str': 'Divided attention'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0232051', 'cui_str': 'Cough reflex'}]",,0.0295246,"Unlike healthy participants, participants with Parkinson's disease did not change the number of coughs between the single-, dual-, and suppressed-task conditions [p > 0.05].","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Perry', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Teachers College, Columbia University, New York, NY, USA. sarah.perry@canterbury.ac.nz.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Troche', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Teachers College, Columbia University, New York, NY, USA.'}]",Dysphagia,['10.1007/s00455-020-10223-x']
397,33386289,Holmium Laser En-bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle-invasive Bladder Cancer: A Randomized Clinical Trial.,"BACKGROUND


En-bloc resection of bladder tumors achieves complete tumor removal, improves the quality of resection, decreases perioperative complication, and potentially improves recurrence rates.
OBJECTIVE


To assess the efficacy and safety of holmium laser en-bloc resection (HolERBT) versus conventional transurethral resection of bladder tumor (cTURBT).
DESIGN, SETTING, AND PARTICIPANTS


Between September 2015 and September 2018, 100 patients with non-muscle-invasive bladder cancer were randomly allocated to cTURBT or HolERBT.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was detection of residual tumor in reTURBT specimens at 4 wk after the primary resection. Operative parameters, specimen quality, perioperative complications, and recurrence-free survival (RFS) were compared. Independent sample t tests, χ 2  tests, and Kaplan-Meier curves were used, as appropriate.
RESULTS AND LIMITATIONS


The patient and tumor baseline characteristics were comparable between the groups. Residual tumors were detected in 7% and 27.7% of cases after HolERBT and cTURBT, respectively (p=0.01). Detrusor muscle was sampled in 98% of HolERBT and 62% of cTURBT cases (p<0.001). Lamina propria invasion substaging was feasible in only 68.2% of HolERBT and 18.4% of cTURBT cases (p<0.001). Following HolERBT, catheterization time (p<0.001) and hospital stay (p=0.001) were shorter when compared to cTURBT. Immediate postoperative instillation of chemotherapy in indicated cases was feasible for 100% of the HolERBT group and 91.5% of the cTURBT group (p=0.04). After follow-up of 20 ± 9.9 mo (13-36), RFS was 31.76 mo (95% confidence interval [CI] 28.67-34.86) in the HolERBT group and 28.25 mo (95% CI 24.87-31.64) in the cTURBT group (hazard ratio 0.43, 95% CI 0.17-1.1; p=0.07). However, this study was not powered to detect a difference in RFS.
CONCLUSIONS


Compared to cTURBT, HolERBT is a safer procedure for bladder tumor resection. It fulfills the oncological criteria of optimized resection with less residual tumor and better specimen quality.
PATIENT SUMMARY


En-bloc resection of bladder cancer tumors using a holmium laser is safer than the conventional technique. It has the advantages of less residual tumor and better specimen quality, with a similar tumor recurrence rate. This study is registered at ClinicalTrials.gov as NCT02555163.",2021,"Following HolERBT, catheterization time (p<0.001) and hospital stay (p=0.001) were shorter when compared to cTURBT.","['Between September 2015 and September 2018, 100 patients with non-muscle-invasive bladder cancer', 'Non-muscle-invasive Bladder Cancer']","['cTURBT, HolERBT', 'Holmium Laser En-bloc Resection Versus Conventional Transurethral Resection', 'holmium laser en-bloc resection (HolERBT', 'chemotherapy', 'conventional transurethral resection', 'holmium laser']","['Residual tumors', 'Detrusor muscle', 'efficacy and safety', 'RFS', 'catheterization time (p<0.001) and hospital stay', 'detection of residual tumor in reTURBT specimens', 'Operative parameters, specimen quality, perioperative complications, and recurrence-free survival (RFS']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",100.0,0.109153,"Following HolERBT, catheterization time (p<0.001) and hospital stay (p=0.001) were shorter when compared to cTURBT.","[{'ForeName': 'Abdelwahab', 'Initials': 'A', 'LastName': 'Hashem', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Mosbah', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Nasr A', 'Initials': 'NA', 'LastName': 'El-Tabey', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Laymon', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'El-Houssieny', 'Initials': 'EH', 'LastName': 'Ibrahiem', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed Abd', 'Initials': 'MA', 'LastName': 'Elhamid', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Elshal', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt. Electronic address: elshalam@hotmail.com.'}]",European urology focus,['10.1016/j.euf.2020.12.003']
398,33386201,"Effect of Pilates mat exercise and home exercise programs on pain, functional level, and core muscle thickness in women with chronic low back pain.","BACKGROUND


To investigate the effects of Pilates exercise in patients with chronic non-specific low back pain (CNLBP) by training core stabilization muscles in aspects such as: pain, functional level, depression, quality of life, and muscle thickness measured by Ultrasound Imaging (UI) and to compare it with home based exercise.
METHODS


A prospective, randomized-single blinded study included 60 female patients with CNLBP. Patients were randomized into Pilates (group 1) or home exercise group (group 2) three times/week for eight weeks. The evaluations were made at the beginning and end of the treatment. Outcome parameters were VAS, Oswestry Disability Index, Qubec Disability Scale, Short Form-36, Beck Depression Questionnaire, sit and reach, Modified Schöber and sit up tests. Multifidus and abdominal muscle thickness were measured by UI.
RESULTS


Significant improvement has been observed in all parameters in both groups. It was found that Group 1 was more effective in terms of all parameters (p < 0.05).
CONCLUSIONS


Both Pilates and home exercises are effective in treating patients with chronic low back pain. UI can be useful for evaluating the core muscle thickness progression of chronic low back pain patients who are undergoing exercise therapy.",2021,"Outcome parameters were VAS, Oswestry Disability Index, Qubec Disability Scale, Short Form-36, Beck Depression Questionnaire, sit and reach, Modified Schöber and sit up tests.","['chronic low back pain patients who are undergoing exercise therapy', 'patients with chronic low back pain', 'patients with chronic non-specific low back pain (CNLBP', 'women with chronic low back pain', '60 female patients with CNLBP']","['Pilates exercise', 'home exercise group', 'Pilates and home exercises', 'Pilates mat exercise and home exercise programs']","['Multifidus and abdominal muscle thickness', 'pain, functional level, and core muscle thickness', 'VAS, Oswestry Disability Index, Qubec Disability Scale, Short Form-36, Beck Depression Questionnaire, sit and reach, Modified Schöber and sit up tests']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}, {'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",60.0,0.0324896,"Outcome parameters were VAS, Oswestry Disability Index, Qubec Disability Scale, Short Form-36, Beck Depression Questionnaire, sit and reach, Modified Schöber and sit up tests.","[{'ForeName': 'Sevilay', 'Initials': 'S', 'LastName': 'Batıbay', 'Affiliation': 'Faculty of Medicine, Department of Physical Therapy and Rehabilitation, Division of Rheumatology, Gazi University, Ankara, Turkey. Electronic address: sevilaycucen@windowslive.com.'}, {'ForeName': 'Duygu Geler', 'Initials': 'DG', 'LastName': 'Külcü', 'Affiliation': 'Haydarpaşa Numune Education and Research Hospital, Department of Physical Medicine and Rehabilitation, Istanbul, Turkey.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Kaleoğlu', 'Affiliation': 'Haydarpaşa Numune Education and Research Hospital, Department of Physical Medicine and Rehabilitation, Istanbul, Turkey.'}, {'ForeName': 'Nilgün', 'Initials': 'N', 'LastName': 'Mesci', 'Affiliation': 'Haydarpaşa Numune Education and Research Hospital, Department of Physical Medicine and Rehabilitation, Istanbul, Turkey.'}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2020.10.026']
399,33393104,The effect of foot care protocol applied to older people on foot health problems and foot care behaviours: a randomised controlled trial in a nursing home.,"OBJECTIVES


This study aimed to develop a protective and improving protocol for foot health of the older people and to assess the effect of this protocol on foot problems, foot care knowledge levels and foot care behavior.
METHODS


This randomized controlled trial that was conducted in a nursing home in Turkey. The research was completed with 57 older people (28 intervention group, 29 control group) over the age of 60 living in a nursing home who met the eligibility criteria. Data were collected using the Older Person Identification Form, Foot Examination Form, Foot Care Knowledge Level Form, and Foot Care Behavior Scale at baseline and 6 months later. When assessing the study data; Descriptive statistics, Student t-test, Mann Whitney U test, Wilcoxon signed ranks test, chi-square test, continuity (Yates) correction, Fisher exact chi-square test, McNemar test and GEE were used.
RESULTS


At the end of the research, there were statistically significant improvements in problems related to dermatology (appearance, hygiene, and moisture); problems related to circulation (temperature); problems related to sensory issues (feeling and pain); problems related to footwear; and problems related to self-care between the intervention and control groups. Also, there were statistically significant improvements in problems related to dermatology (appearance and hygiene); problems related to circulation (temperature, color, and edema); and problems related to sensory issues (feeling and pain) for the posttest compared to the pretest in the intervention group (p < 0.05). In terms of foot care knowledge level and foot care behavior scale mean scores, statistically significant differences were found between the groups and for the intervention group pretest and posttest mean scores.
CONCLUSION


The foot care protocol applied to older people was identified to reduce foot problems by a significant level, and increase mean points for knowledge levels about foot care and the foot care behavior scale.",2021,"In terms of foot care knowledge level and foot care behavior scale mean scores, statistically significant differences were found between the groups and for the intervention group pretest and posttest mean scores.
","['57 older people (28 intervention group, 29 control group) over the age of 60 living in a nursing home who met the eligibility criteria', 'older people on foot health problems and foot care behaviours', 'nursing home in Turkey']",[],"['Older Person Identification Form, Foot Examination Form, Foot Care Knowledge Level Form, and Foot Care Behavior Scale', 'Mann Whitney U test, Wilcoxon signed ranks test, chi-square test, continuity (Yates) correction, Fisher exact chi-square test, McNemar test and GEE', 'problems related to dermatology (appearance and hygiene); problems related to circulation (temperature, color, and edema); and problems related to sensory issues (feeling and pain', 'problems related to dermatology (appearance, hygiene, and moisture']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0267642', 'cui_str': 'Celiac infantilism'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0304028,"In terms of foot care knowledge level and foot care behavior scale mean scores, statistically significant differences were found between the groups and for the intervention group pretest and posttest mean scores.
","[{'ForeName': 'Aslıhan', 'Initials': 'A', 'LastName': 'Çatıker', 'Affiliation': 'Department of Nursing, Ordu University Faculty of Health Sciences, Ordu, Turkey.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Zincir', 'Affiliation': 'Faculty of Health Sciences, Department of Nursing, Public Health Nursing Department, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Emine Ümit', 'Initials': 'EÜ', 'LastName': 'Seviğ', 'Affiliation': 'Faculty of Nursing, Public Health Nursing Department, Near East University, Nicosia/TRNC, Cyprus.'}]",Scandinavian journal of caring sciences,['10.1111/scs.12949']
400,33392969,The Cost-Effectiveness of Adapting and Implementing a Brief Intervention to Target Frequent Alcohol Use Among Persons with HIV in Vietnam.,"Brief interventions to reduce frequent alcohol use among persons with HIV (PWH) are evidence-based, but resource-constrained settings must contend with competition for health resources. We evaluated the cost-effectiveness of two intervention arms compared to the standard of care (SOC) in a three-arm randomized control trial targeting frequent alcohol use in PWH through increasing the percent days abstinent from alcohol and viral suppression. We estimated incremental cost per quality-adjusted life year (QALY) gained from a modified societal perspective and a 1-year time horizon using a Markov model of health outcomes. The two-session brief intervention (BI), relative to the six-session combined intervention (CoI), was more effective and less costly; the estimated incremental cost-effectiveness of the BI relative to the SOC, was $525 per QALY gained. The BI may be cost-effective for the HIV treatment setting; the health utility gained from viral suppression requires further exploration.",2021,The BI may be cost-effective for the HIV treatment setting; the health utility gained from viral suppression requires further exploration.,"['Persons with HIV in Vietnam', 'persons with HIV (PWH']",['standard of care (SOC'],"['Cost-Effectiveness', 'cost-effectiveness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.014776,The BI may be cost-effective for the HIV treatment setting; the health utility gained from viral suppression requires further exploration.,"[{'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Blackburn', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA. nblackbu@live.unc.edu.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA.'}, {'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Bui', 'Affiliation': 'University of North Carolina Project Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hutton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Radhika P', 'Initials': 'RP', 'LastName': 'Tampi', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA.'}, {'ForeName': 'Tran Viet', 'Initials': 'TV', 'LastName': 'Ha', 'Affiliation': 'University of North Carolina Project Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Golden', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Golin', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Gottfredson', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03139-y']
401,33402248,Waterpipe Warning Placement and Risk Perceptions: An Eye Tracking Study.,"Objectives:  The purpose of this study was to select a health warning message location on a waterpipe (WP) that both attracted visual attention and conveyed the risks associated with WP smoking.  Methods:  During June through November 2019, we conducted a within-subjects randomized experiment (N = 74) using eye tracking equipment to examine visual attention to 3 placements of a health warning on the WP (stem, water bowl, hose). We asked young adult ever WP users 3 questions about WP harm perceptions. We used generalized linear mixed models to examine the amount of fixation time spent on the placement locations; we used repeated measures ANOVA to model changes in harm perceptions.  Results:  There were statistically significant differences across all 3 placement locations; regardless of place, all HWLs attracted a comparable amount of visual attention. Absolute WP harm perceptions significantly increased following the experiment and remained significantly higher at the one-week follow-up, compared to baseline.  Conclusions:  Warnings on WPs attracted visual attention and increased harm perceptions, and those harm perceptions remained high one week after the experiment. Findings indicate the value of including a warning on the WP device, and underscore the necessity and effectiveness of those health warnings to combat WP harm misperceptions.",2021,"Absolute WP harm perceptions significantly increased following the experiment and remained significantly higher at the one-week follow-up, compared to baseline.  ",['young adult ever WP users 3 questions about WP harm perceptions'],"['eye tracking equipment to examine visual attention to 3 placements of a health warning on the WP (stem, water bowl, hose']","['Absolute WP harm perceptions', 'visual attention']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0336949', 'cui_str': 'Bowling'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}]",,0.0200233,"Absolute WP harm perceptions significantly increased following the experiment and remained significantly higher at the one-week follow-up, compared to baseline.  ","[{'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Klein', 'Affiliation': 'Elizabeth G. Klein, Associate Professor, The Ohio State University College of Public Health, Columbus, OH, United States;, Email: klein.232@osu.edu.'}, {'ForeName': 'Mahmood A', 'Initials': 'MA', 'LastName': 'Alalwan', 'Affiliation': 'Mahmood A. Alalwan, Student Research Assistant, The Ohio State University College of Public Health, Columbus, OH, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Pennell', 'Affiliation': 'Michael L. Pennell, Associate Professor, The Ohio State University College of Public Health, Columbus, OH, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Angeles', 'Affiliation': 'David Angeles, Graduate Research Assistant, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Marielle C', 'Initials': 'MC', 'LastName': 'Brinkman', 'Affiliation': 'Marielle C. Brinkman, Senior Research Scientist, The Ohio State University College of Public Health, Columbus, OH, United States.'}, {'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Keller-Hamilton', 'Affiliation': 'Brittney Keller-Hamilton, Research Scientist, The Ohio State University Comprehensive Cancer Center, Columbus, OH, United States.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Roberts', 'Affiliation': 'Megan E. Roberts, Assistant Professor, The Ohio State University College of Public Health, Columbus, OH, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nini', 'Affiliation': 'Paul Nini, Professor, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Ferketich', 'Affiliation': 'Amy K. Ferketich, United States, Professor, The Ohio State University College of Public Health, Columbus, OH, United States.'}]",American journal of health behavior,['10.5993/AJHB.45.1.15']
402,33395173,Effect of Scenario-Based Simulation Training on the Obstetrics and Gynecology Nursing Clinical Practicum.,"BACKGROUND


Simulation practices in obstetrics and gynecology (OB-GYN) nursing are used in education, practice, assessment, and the investigation of interventional and behavioral skills related to both routine and emergency conditions.
PURPOSE


This study was conducted in an OB-GYN nursing course to determine the effect of simulation practices on clinical practice satisfaction, clinical stress, and self-confidence in nursing students.
METHODS


A cluster randomized controlled experimental trial was conducted on 122 students (experimental group, n = 58; control group, n = 64). After theoretical training, all of the students applied six scenarios in the OB-GYN nursing simulation laboratory. The students in the experimental group began clinical practice after simulation training, whereas their peers in the control group began clinical practice without prior simulation training. Data in this study were collected using a personal information form, the Pagana Clinical Stress Questionnaire, a self-confidence scale, and a satisfaction subscale from the Clinical Learning Environment Scale on, respectively, the first day and final day of clinical practice.
RESULTS


At the end of the clinical practice, average clinical stress in the control group was higher than that in the experimental group (p = .001). No intergroup difference was found in self-confidence levels (p > .05). For the control group, at posttest, the average satisfaction with the clinical learning environment was higher (p = .046) and the average satisfaction with the clinical learning environment was lower (p = .05). In contrast, no mean pretest-posttest differences were found in clinical stress and self-confidence levels in the experimental group (p > .05). In the control group, no mean pretest-posttest difference was found for the clinical learning environment (p > .05), whereas mean clinical stress (p < .001) and self-confidence (p = .012) levels were higher at posttest (p < .05).
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


The findings of this study indicate that simulation training interventions reduce clinical satisfaction and stress in students but do not influence self-confidence. Nursing educators may provide scenario-based simulation training to students taking OB-GYN courses to enhance their preparedness for clinical practice.",2021,"In the control group, no mean pretest-posttest difference was found for the clinical learning environment (p > .05), whereas mean clinical stress (p < .001) and self-confidence (p = .012) levels were higher at posttest (p < .05).
","['nursing students', '122 students (experimental group, n = 58; control group, n = 64']","['simulation training interventions', 'Scenario-Based Simulation Training']","['clinical learning environment', 'self-confidence', 'clinical practice satisfaction, clinical stress, and self-confidence', 'average clinical stress', 'self-confidence levels', 'clinical stress and self-confidence levels', 'mean clinical stress', 'average satisfaction with the clinical learning environment']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",122.0,0.020703,"In the control group, no mean pretest-posttest difference was found for the clinical learning environment (p > .05), whereas mean clinical stress (p < .001) and self-confidence (p = .012) levels were higher at posttest (p < .05).
","[{'ForeName': 'Ayten', 'Initials': 'A', 'LastName': 'Şentürk Erenel', 'Affiliation': 'PhD, Professor, Faculty of Health Sciences, Nursing Department, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Şengül', 'Initials': 'Ş', 'LastName': 'Yaman Sözbir', 'Affiliation': 'PhD, Associate Professor, Faculty of Health Sciences, Nursing Department, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Mehtap', 'Initials': 'M', 'LastName': 'Uzun Aksoy', 'Affiliation': 'PhD, RN, Lecturer, Faculty of Health Sciences, Nursing Department, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Arslan Gürcüoğlu', 'Affiliation': 'PhD, RN, Research Assistant, Faculty of Health Sciences, Nursing Department, Çankırı Karatekin University, Çankırı, Turkey.'}, {'ForeName': 'Sıdıka', 'Initials': 'S', 'LastName': 'Pelit Aksu', 'Affiliation': 'MSN, RN, Research Assistant, Faculty of Health Sciences, Nursing Department, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Ünal Toprak', 'Affiliation': 'PhD, RN, Assistant Professor, Faculty of Health Sciences, Nursing Department, Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Uçakci Asalioğlu', 'Affiliation': 'MSN, RN, Research Assistant, Faculty of Health Sciences, Nursing Department, Gazi University, Ankara, Turkey.'}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000417']
403,33398922,Cognitive behavioural social skills training: Methods of a randomized controlled trial for youth at risk of psychosis.,"AIM


Poor functioning has become a hallmark of many youth at clinical high-risk (CHR) of psychosis. Even for those who do not make the transition to psychosis remain troubled by functional deficits and a decline in functioning increases the odds of transitioning to psychosis. There are very few treatment studies that have attempted to improve social and role functioning. The aim of this paper is to describe the methods of a treatment study to address social and role functioning in CHR.
METHODS


This was a randomized controlled trial of cognitive-behavioural social skills training (CBSST) versus a supportive therapy. CBSST combines elements of cognitive behaviour therapy (CBT) and social skills training (SST), two evidence-based treatments for schizophrenia. By adding CBT to SST to target functioning outcomes, SST can be used to train new social skills, and thoughts that interfere with skilled performance in the real world can be addressed using CBT. We developed an adapted version of CBSST, more appropriate for the age range and illness severity of typical CHR individuals, to attempt to show improvements in social and role functioning for these young people.
RESULTS


Two hundred and three participants were recruited for this study. Results include initial baseline data.
CONCLUSION


This article describes the baseline methodology of a CHR youth who have difficulties in social and/or role functioning. It is one of the first clinical trials to address this significant problem.",2021,"We developed an adapted version of CBSST, more appropriate for the age range and illness severity of typical CHR individuals, to attempt to show improvements in social and role functioning for these young people.
","['youth at risk of psychosis', 'Two hundred and three participants were recruited for this study', 'CHR youth who have difficulties in social and/or role functioning']","['cognitive behaviour therapy (CBT) and social skills training (SST', 'Cognitive behavioural social skills training', 'cognitive-behavioural social skills training (CBSST']",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0035820', 'cui_str': 'Role'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0150777', 'cui_str': 'Social skills training'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]",[],203.0,0.070471,"We developed an adapted version of CBSST, more appropriate for the age range and illness severity of typical CHR individuals, to attempt to show improvements in social and role functioning for these young people.
","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Addington', 'Affiliation': 'Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Santesteban-Echarri', 'Affiliation': 'Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kali', 'Initials': 'K', 'LastName': 'Brummitt', 'Affiliation': 'Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Braun', 'Affiliation': 'Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kristin S', 'Initials': 'KS', 'LastName': 'Cadenhead', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, California, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Cornblatt', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Long Island, New York, USA.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Holden', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, California, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Granholm', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, California, USA.'}]",Early intervention in psychiatry,['10.1111/eip.13102']
404,33423141,Testing the sleep hygiene recommendation against nighttime exercise.,"PURPOSE


Experts have recommended exercise for improved sleep, but often with the caveat that one should avoid nighttime exercise. The aim of this study was to challenge this recommendation in a sample who might be most prone to sleep impairment after nighttime exercise. The secondary aims were to assess whether or not post-treatment sleep was correlated with anxiolytic effects or downregulation of body temperature.
METHODS


Twelve sedentary adults with insomnia completed two treatments (separated by 2-5 days) in counterbalanced order: (1) 30 min of moderate treadmill exercise (60-70% maximum heart rate) + 15 min of moderate resistance exercise and (2) a control treatment (reading). Each treatment was completed 2 h before bedtime and followed by a 10-min shower, a light snack, 8 h of polysomnographic recording, and a sleep questionnaire. State anxiety was assessed before and 30 min after each treatment and 10 min before bedtime. Body temperature was assessed from pre-exercise to wake time.
RESULTS


No significant treatment differences in sleep were found, and Hedges g paired comparisons indicated small effect sizes; however, two participants had severely disturbed objective sleep following exercise. Significant correlations were found between change in state anxiety from pre-exercise to bedtime and TST (r = 0.69, p = 0.03). Stage 1 (r = 0.67, p = 0.03), WASO (r = 0.69, p = 0.03), and sleep efficiency (r = 0.66, p = 0.02). No significant correlations were found of sleep with temperature decline.
CONCLUSIONS


Profound sleep disturbance after exercise in some participants, and no marked sleep improvement in the others, provides some support for caution regarding late-night exercise for sedentary individuals with insomnia.",2021,"No significant treatment differences in sleep were found, and Hedges g paired comparisons indicated small effect sizes; however, two participants had severely disturbed objective sleep following exercise.","['sedentary individuals with insomnia', 'Twelve sedentary adults with insomnia completed two treatments (separated by 2-5 days) in counterbalanced order: (1) 30 min of']",['moderate treadmill exercise (60-70% maximum heart rate) + 15 min of moderate resistance exercise and (2) a control treatment (reading'],"['Body temperature', 'sleep', 'state anxiety', 'severely disturbed objective sleep', 'anxiolytic effects or downregulation of body temperature', 'State anxiety', 'sleep efficiency', 'sleep with temperature decline', 'WASO']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",12.0,0.0628544,"No significant treatment differences in sleep were found, and Hedges g paired comparisons indicated small effect sizes; however, two participants had severely disturbed objective sleep following exercise.","[{'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'Youngstedt', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, USA. Shawn.youngstedt@asu.edu.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Ito', 'Affiliation': 'Institute of Neuropsychiatry, Tokyo, Japan.'}, {'ForeName': 'Giselle Soares', 'Initials': 'GS', 'LastName': 'Passos', 'Affiliation': 'Universidade Federal de Jataí, Jataí, GO, Brazil.'}, {'ForeName': 'Marcos Gonçalves', 'Initials': 'MG', 'LastName': 'Santana', 'Affiliation': 'Universidade Federal de Jataí, Jataí, GO, Brazil.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Youngstedt', 'Affiliation': 'Red Mountain High School, Mesa, AZ, USA.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02284-x']
405,33481251,Acute hyperglycaemia enhances both vascular endothelial function and cardiac and skeletal muscle microvascular function in healthy humans.,"KEY POINTS


Multiple clinical studies report that acute hyperglycaemia (induced by mixed meal or oral glucose) decreases arterial vascular function in healthy humans. Feeding, however, impacts autonomic output, blood pressure, and insulin and incretin secretion, which may themselves alter vascular function. No prior studies have examined the effect of acute hyperglycaemia on both macro- and microvascular function while controlling plasma insulin concentrations. Macrovascular and microvascular functional responses to euglycaemia and hyperglycaemia were compared. Octreotide was infused throughout both protocols to prevent endogenous insulin release. Acute hyperglycaemia (induced by intravenous glucose) enhanced brachial artery flow-mediated dilatation, increased skeletal muscle microvascular blood volume and flow, and expanded cardiac muscle microvascular blood volume. Compared to other published findings, the results suggest that vascular responses to acute hyperglycaemia differ based on the study population (i.e. normal weight vs. overweight/obese) and/or glucose delivery method (i.e. intravenous vs. oral glucose).
ABSTRACT


High glucose concentrations acutely provoke endothelial cell oxidative stress and are suggested to trigger diabetes-related macro- and microvascular injury in humans. Multiple clinical studies report that acute hyperglycaemia (induced by mixed meal or oral glucose) decreases arterial vascular function in healthy humans. Feeding, however, impacts autonomic output, blood pressure, and insulin and incretin secretion, which may each independently alter vascular function and obscure the effect of acute hyperglycaemia per se. Surprisingly, no studies have examined the acute effects of intravenous glucose-induced hyperglycaemia on both macro- and microvascular function while controlling plasma insulin concentrations. In this randomized study of healthy young adults, we compared macrovascular (i.e. brachial artery flow-mediated dilatation, carotid-femoral pulse wave velocity and post-ischaemic brachial artery flow velocity) and microvascular (heart and skeletal muscle perfusion by contrast-enhanced ultrasound) functional responses to euglycaemia and hyperglycaemia. Octreotide was infused throughout both protocols to prevent endogenous insulin release. Acute intravenous glucose-induced hyperglycaemia enhanced brachial artery flow-mediated dilatation (P = 0.004), increased skeletal muscle microvascular blood volume and flow (P = 0.001), and expanded cardiac muscle microvascular blood volume (P = 0.014). No measure of vascular function changed during octreotide-maintained euglycaemia. Our findings suggest that unlike meal-provoked acute hyperglycaemia, 4 h of intravenous glucose-induced hyperglycaemia enhances brachial artery flow-mediated dilatation, provokes cardiac and skeletal muscle microvascular function, and does not impair aortic stiffness. Previous findings of acute large artery vascular dysfunction during oral glucose or mixed meal ingestion may be due to differences in study populations and meal-induced humoral or neural factors beyond hyperglycaemia per se. (ClinicalTrials.gov number NCT03520569.).",2021,"Acute intravenous glucose-induced hyperglycemia enhanced brachial artery flow-mediated dilation (p = 0.004), increased skeletal muscle microvascular blood volume and flow (p = 0.001), and expanded cardiac muscle microvascular blood volume (p = 0.014).","['healthy young adults', 'healthy humans']","['Octreotide', 'mixed meal or oral glucose', 'octreotide-maintained euglycemia']","['expanded cardiac muscle microvascular blood volume', 'brachial artery flow-mediated dilation, increased skeletal muscle microvascular blood volume and flow, and expanded cardiac muscle microvascular blood volume', 'skeletal muscle microvascular blood volume and flow', 'vascular function', 'Acute hyperglycemia', 'hyperglycemia enhanced brachial artery flow-mediated dilation', 'arterial vascular function', 'macrovascular and microvascular functional responses', 'macrovascular (i.e., brachial artery flow-mediated dilation, carotid-femoral pulse wave velocity, and post-ischemic brachial artery flow velocity) and microvascular (heart and skeletal muscle perfusion', 'autonomic output, blood pressure, and insulin and incretin secretion']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0342301', 'cui_str': 'Acute hyperglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",,0.055063,"Acute intravenous glucose-induced hyperglycemia enhanced brachial artery flow-mediated dilation (p = 0.004), increased skeletal muscle microvascular blood volume and flow (p = 0.001), and expanded cardiac muscle microvascular blood volume (p = 0.014).","[{'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Horton', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Jahn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Hartline', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Aylor', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Patrie', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Barrett', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA, USA.'}]",The Journal of physiology,['10.1113/JP281286']
406,33422558,"Age Effect on Treatment Responses to 0.05%, 0.025%, and 0.01% Atropine: Low-Concentration Atropine for Myopia Progression Study.","PURPOSE


To investigate the effect of age at treatment and other factors on treatment response to atropine in the Low-Concentration Atropine for Myopia Progression (LAMP) Study.
DESIGN


Secondary analysis from a randomized trial.
PARTICIPANTS


Three hundred fifty children aged 4 to 12 years who originally were assigned to receive 0.05%, 0.025%, or 0.01% atropine or placebo once daily, and who completed 2 years of the LAMP Study, were included. In the second year, the placebo group was switched to the 0.05% atropine group.
METHODS


Potential predictive factors for change in spherical equivalent (SE) and axial length (AL) over 2 years were evaluated by generalized estimating equations in each treatment group. Evaluated factors included age at treatment, gender, baseline refraction, parental myopia, time outdoors, diopter hours of near work, and treatment compliance. Estimated mean values and 95% confidence intervals (CIs) of change in SE and AL over 2 years also were generated.
MAIN OUTCOME MEASURES


Factors associated with SE change and AL change over 2 years were the primary outcome measures. Associated factors during the first year were secondary outcome measures.
RESULTS


In 0.05%, 0.025%, and 0.01% atropine groups, younger age was the only factor associated with SE progression (coefficient of 0.14, 0.15, and 0.20, respectively) and AL elongation (coefficient of -0.10, -0.11, and -0.12, respectively) over 2 years; the younger the age, the poorer the response. At each year of age from 4 to 12 years across the treatment groups, higher-concentration atropine showed a better treatment response, following a concentration-dependent effect (P trend  <0.05 for each age group). In addition, the mean SE progression in 6-year-old children receiving 0.05% atropine (-0.90 diopter [D]; 95% CI, -0.99 to -0.82) was similar to that of 8-year-old children receiving 0.025% atropine (-0.89 D; 95% CI, -0.94 to -0.83) and 10-year-old children receiving 0.01% atropine (-0.92 D; 95% CI, -0.99 to -0.85). All concentrations were well tolerated in all age groups.
CONCLUSIONS


Younger age is associated with poor treatment response to low-concentration atropine at 0.05%, 0.025%, and 0.01%. Among concentrations studied, younger children required the highest 0.05% concentration to achieve similar reduction in myopic progression as older children receiving lower concentrations.",2021,"All concentrations were well tolerated at all age groups.
","['once daily in both eyes who completed 2 years of the LAMP study were included in this study', '350 children, aged 4 to 12 years, randomization stratified by age and gender, originally assigned to receive 0.05%, 0.025%, 0.01']","['placebo', 'atropine, or placebo', 'atropine (-0.89D, 95%CI', 'atropine', 'atropine: Low-concentration Atropine']","['SE progression', 'spherical equivalent (SE) and axial length (AL', 'myopic progression', 'mean SE progression']","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C4517400', 'cui_str': '0.025'}, {'cui': 'C4517393', 'cui_str': '0.01'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",350.0,0.238738,"All concentrations were well tolerated at all age groups.
","[{'ForeName': 'Fen Fen', 'Initials': 'FF', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yuzhou', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Benjamin Hon Kei', 'Initials': 'BHK', 'LastName': 'Yip', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong.'}, {'ForeName': 'Shu Min', 'Initials': 'SM', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Ka Wai', 'Initials': 'KW', 'LastName': 'Kam', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Alvin L', 'Initials': 'AL', 'LastName': 'Young', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Li Jia', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Clement C', 'Initials': 'CC', 'LastName': 'Tham', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong SAR, China; Hong Kong Eye Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Chi Pui', 'Initials': 'CP', 'LastName': 'Pang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Hong Kong Eye Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Yam', 'Affiliation': ""Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong SAR, China; Hong Kong Eye Hospital, Hong Kong SAR, China; Department of Ophthalmology, Hong Kong Children's Hospital, Hong Kong SAR, China. Electronic address: yamcheuksing@cuhk.edu.hk.""}]",Ophthalmology,['10.1016/j.ophtha.2020.12.036']
407,33417506,Phase III Randomized Controlled Trial of eRAPID: eHealth Intervention During Chemotherapy.,"PURPOSE


Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online eHealth system for patients to self-report symptoms during cancer treatment. It provides automated severity-dependent patient advice guiding self-management or medical contact and displays the reports in electronic patient records. This trial evaluated the impact of eRAPID on symptom control, healthcare use, patient self-efficacy, and quality of life (QOL) in a patient population treated predominantly with curative intent.
METHODS


Patients with colorectal, breast, or gynecological cancers commencing chemotherapy were randomly assigned to usual care (UC) or the addition of eRAPID (weekly online symptom reporting for 18 weeks). Primary outcome was symptom control (Functional Assessment of Cancer Therapy-General, Physical Well-Being subscale [FACT-PWB]) assessed at 6, 12, and 18 weeks. Secondary outcomes were processes of care (admissions or chemotherapy delivery), patient self-efficacy, and global quality of life (Functional Assessment of Cancer Therapy-General, EQ5D-VAS, and EORTC QLQ-C30 summary score). Multivariable mixed-effects repeated-measures models were used for analyses. Trial registration: ISRCTN88520246.
RESULTS


Participants were 508 consenting patients (73.6% of 690 eligible) and 55 health professionals. eRAPID compared to UC showed improved physical well-being at 6 ( P  = .028) and 12 ( P  = .039) weeks and no difference at 18 weeks (primary end point) ( P  = .69). Fewer eRAPID patients (47%) had clinically meaningful physical well-being deterioration than UC (56%) at 12 weeks. Subgroup analysis found benefit in the nonmetastatic group at 6 weeks ( P  = .0426), but not in metastatic disease. There were no differences for admissions or chemotherapy delivery. At 18 weeks, patients using eRAPID reported better self-efficacy ( P  = .007) and better health on EQ5D-VAS ( P  = .009). Average patient compliance with weekly symptom reporting was 64.7%. Patient adherence was associated with clinician's data use and improved FACT-PWB at 12 weeks.
CONCLUSION


Real-time monitoring with electronic patient-reported outcomes improved physical well-being (6 and 12 weeks) and self-efficacy (18 weeks) in a patient population predominantly treated with curative intent, without increasing hospital workload.",2021,"At 18 weeks, patients using eRAPID reported better self-efficacy ( P  = .007) and better health on EQ5D-VAS ( P  = .009).","['Participants were 508 consenting patients (73.6% of 690 eligible) and 55 health professionals', 'patient population treated predominantly with curative intent', 'Electronic patient self-Reporting of Adverse-events', 'Patients with colorectal, breast, or gynecological cancers commencing chemotherapy']","['eRAPID: eHealth Intervention During Chemotherapy', 'usual care (UC) or the addition of eRAPID']","['symptom control (Functional Assessment of Cancer Therapy-General, Physical Well-Being subscale [FACT-PWB', 'health on EQ5D-VAS', 'self-efficacy', 'Average patient compliance with weekly symptom reporting', 'processes of care (admissions or chemotherapy delivery), patient self-efficacy, and global quality of life (Functional Assessment of Cancer Therapy-General, EQ5D-VAS, and EORTC QLQ-C30 summary score', 'symptom control, healthcare use, patient self-efficacy, and quality of life (QOL']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",508.0,0.112281,"At 18 weeks, patients using eRAPID reported better self-efficacy ( P  = .007) and better health on EQ5D-VAS ( P  = .009).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Absolom', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Warrington', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Hudson', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hewison', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Morris', 'Affiliation': 'Patient Representative, Independent Cancer Patients Voices, Brighton, United Kingdom.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Holch', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Carter', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gibson', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Holmes', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Clayton', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Rogers', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'McParland', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conner', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Glidewell', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Woroncow', 'Affiliation': ""Patient Representative, Research Advisory Group to Patient-Centred Outcomes Research at Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Dawkins', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dickinson', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Velikova', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02015']
408,33491052,Comparison of Lateral Perturbation-Induced Step Training and Hip Muscle Strengthening Exercise on Balance and Falls in Community-Dwelling Older Adults: A Blinded Randomized Controlled Trial.,"BACKGROUND


This factorial, assessor-blinded, randomized, and controlled study compared the effects of perturbation-induced step training (lateral waist-pulls), hip muscle strengthening, and their combination, on balance performance, muscle strength, and prospective falls among older adults.
METHODS


Community-dwelling older adults were randomized to 4 training groups. Induced step training (IST, n = 25) involved 43 progressive perturbations. Hip abduction strengthening (HST, n = 25) utilized progressive resistance exercises. Combined training (CMB, n = 25) included IST and HST, and the control performed seated flexibility/relaxation exercises (SFR, n = 27). The training involved 36 sessions for a period of 12 weeks. The primary outcomes were the number of recovery steps and first step length, and maximum hip abduction torque. Fall frequency during 12 months after training was determined.
RESULTS


Overall, the number of recovery steps was reduced by 31% and depended upon the first step type. IST and CMB increased the rate of more stable single lateral steps pre- and post-training than HST and SFR who used more multiple crossover and sequential steps. The improved rate of lateral steps for CMB exceeded the control (CMB/SFR rate ratio 2.68). First step length was unchanged, and HST alone increased hip torque by 25%. Relative to SFR, the fall rate ratios (falls/person/year) [95% confidence interval] were CMB 0.26 [0.07-0.90], IST 0.44 [0.18-1.08], and HST 0.30 (0.10-0.91).
CONCLUSIONS


Balance performance through stepping was best improved by combining perturbation and strength training and not strengthening alone. The interventions reduced future falls by 56%-74% over the control. Lateral balance perturbation training may enhance traditional programs for fall prevention.",2021,IST and CMB increased the rate of more stable single lateral steps pre-post training than HST and SFR who used more multiple crossover and sequential steps.,"['older adults', 'Community Dwelling Older Adults', 'community-dwelling older adults']","['Hip abduction strengthening (HST, n=25) utilized progressive resistance exercises', 'perturbation-induced step training (lateral waist-pulls), hip muscle strengthening, and their combination', 'Lateral Perturbation-Induced Step Training and Hip Muscle Strengthening Exercise', 'HST', 'Lateral balance perturbation training', 'Combined training (CMB, n=25) included IST and HST, and the control performed seated flexibility/relaxation exercises']","['number of recovery steps and first step length, and maximum hip abduction torque', 'fall rate ratios (falls/person/year', 'IST and CMB', 'Balance and Falls', 'hip torque', 'Fall frequency', 'rate of lateral steps for CMB', 'number of recovery steps']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C1451207', 'cui_str': 'FGF4 protein, human'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0203993', 'cui_str': 'Relaxation exercise'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]",,0.0495698,IST and CMB increased the rate of more stable single lateral steps pre-post training than HST and SFR who used more multiple crossover and sequential steps.,"[{'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Rogers', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Maryland School of Medicine, Baltimore, US.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Creath', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Maryland School of Medicine, Baltimore, US.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Gray', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Maryland School of Medicine, Baltimore, US.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Abarro', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Maryland School of Medicine, Baltimore, US.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'McCombe Waller', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Maryland School of Medicine, Baltimore, US.'}, {'ForeName': 'Brock A', 'Initials': 'BA', 'LastName': 'Beamer', 'Affiliation': 'Division of Gerontology and Geriatric Medicine, University of Maryland School of Medicine, Baltimore, US.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'Division of Gerontology and Geriatric Medicine, University of Maryland School of Medicine, Baltimore, US.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab017']
409,33436401,"OGTT Glucose Response Curves, Insulin Sensitivity, and β-Cell Function in RISE: Comparison Between Youth and Adults at Randomization and in Response to Interventions to Preserve β-Cell Function.","OBJECTIVE


We examined the glucose response curves (biphasic [BPh], monophasic [MPh], incessant increase [IIn]) during an oral glucose tolerance test (OGTT) and their relationship to insulin sensitivity (IS) and β-cell function (βCF) in youth versus adults with impaired glucose tolerance or recently diagnosed type 2 diabetes.RESEARCH DESIGN AND METHODSThis was both a cross-sectional and a longitudinal evaluation of participants in the RISE study randomized to metformin alone for 12 months or glargine for 3 months followed by metformin for 9 months. At baseline/randomization, OGTTs (85 youth, 353 adults) were categorized as BPh, MPh, or IIn. The relationship of the glucose response curves to hyperglycemic clamp-measured IS and βCF at baseline and the change in glucose response curves 12 months after randomization were assessed.RESULTSAt randomization, the prevalence of the BPh curve was significantly higher in youth than adults (18.8% vs. 8.2%), with no differences in MPh or IIn. IS did not differ across glucose response curves in youth or adults. However, irrespective of curve type, youth had lower IS than adults ( P  < 0.05). βCF was lowest in IIn versus MPh and BPh in youth and adults ( P  < 0.05), yet compared with adults, youth had higher βCF in BPh and MPh ( P  < 0.005) but not IIn. At month 12, the change in glucose response curves did not differ between youth and adults, and there was no treatment effect.CONCLUSIONSDespite a twofold higher prevalence of the more favorable BPh curve in youth at randomization, RISE interventions did not result in beneficial changes in glucose response curves in youth compared with adults. Moreover, the typical β-cell hypersecretion in youth was not present in the IIn curve, emphasizing the severity of β-cell dysfunction in youth with this least favorable glucose response curve.",2021,"βCF was lowest in IIn versus MPh and BPh in youth and adults ( P  < 0.05), yet compared with adults, youth had higher βCF in BPh and MPh ( P  < 0.005) but not IIn.",['youth versus adults with impaired glucose tolerance or recently diagnosed type 2 diabetes'],"['metformin', 'glargine']","['OGTT Glucose Response Curves, Insulin Sensitivity, and β-Cell Function', 'glucose response curves', 'glucose response curves (biphasic [BPh], monophasic [MPh], incessant increase [IIn]) during an oral glucose tolerance test (OGTT) and their relationship to insulin sensitivity (IS) and β-cell function (βCF', 'βCF', 'prevalence of the BPh curve']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0205186', 'cui_str': 'Monophasic'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]",353.0,0.0309929,"βCF was lowest in IIn versus MPh and BPh in youth and adults ( P  < 0.05), yet compared with adults, youth had higher βCF in BPh and MPh ( P  < 0.005) but not IIn.","[{'ForeName': 'Silva A', 'Initials': 'SA', 'LastName': 'Arslanian', 'Affiliation': ""University of Pittsburgh, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'George Washington University Biostatistics Center (RISE Coordinating Center), Rockville, MD rise@bsc.gwu.edu.'}, {'ForeName': 'Joon Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Exercise Science, Syracuse University, Syracuse, NY.'}, {'ForeName': 'Ashley H', 'Initials': 'AH', 'LastName': 'Tjaden', 'Affiliation': 'George Washington University Biostatistics Center (RISE Coordinating Center), Rockville, MD.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barengolts', 'Affiliation': 'Jesse Brown VA Medical Center, Chicago, IL.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Denver, CO.""}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'VA Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-2134']
410,33410612,Effect of Permissive Mild Hypercapnia on Cerebral Vasoreactivity in Infants: A Randomized Controlled Crossover Trial.,"BACKGROUND


Mechanical ventilation interferes with cerebral perfusion via changes in intrathoracic pressure and/or as a consequence of alterations in CO2. Cerebral vascular vasoreactivity is dependent on CO2, and hypocapnia can potentially lead to vasoconstriction and subsequent decrease in cerebral blood flow. Thus, we aimed at characterizing whether protective ventilation with mild permissive hypercapnia improves cerebral perfusion in infants.
METHODS


Following ethical approval and parental consent, 19 infants were included in this crossover study and randomly assigned to 2 groups for which the initial ventilation parameters were set to achieve an end-tidal carbon dioxide (Etco2) of 6.5 kPa (group H: mild hypercapnia, n = 8) or 5.5 kPa (group N: normocapnia, n = 11). The threshold was then reversed before going back to the initial set value of normo- or hypercapnia. At each step, hemodynamic, respiratory, and near-infrared spectroscopy (NIRS)-derived parameters, including tissue oxygenation index (TOI) and tissue hemoglobin index (THI), concentration of deoxygenated hemoglobin (HHb) and oxygenated hemoglobin (O2Hb), were collected. Concomitantly, sevoflurane maintenance concentration, ventilatory (driving pressure) and hemodynamic parameters, as mean arterial pressure (MAP), were recorded.
RESULTS


Targeting an Etco2 of 5.5 kPa resulted in significantly higher mean driving pressure than an Etco2 of 6.5 kPa (P < .01) with no difference between the groups in end-tidal sevoflurane, MAP, and heart rate. A large scatter was observed in NIRS-derived parameters, with no evidence for difference in Etco2 changes between or within groups. A mild decrease with time was observed in THI and MAP in infants randomly assigned to group N (P < .036 and P < .017, respectively). When pooling all groups together, a significant correlation was found between the changes in MAP and TOI (r = 0.481, P < .001).
CONCLUSIONS


Allowing permissive mild hypercapnia during mechanical ventilation of infants led to lower driving pressure and comparable hemodynamic, respiratory, and cerebral oxygenation parameters than during normocapnia. Whereas a large scatter in NIRS-derived parameters was observed at all levels of Etco2, the correlation between TOI and MAP suggests that arterial pressure is an important component of cerebral oxygenation at mild hypercapnia.",2021,"A mild decrease with time was observed in THI and MAP in infants randomly assigned to group N (P < .036 and P < .017, respectively).","['Infants', '19 infants', 'infants']","['Mechanical ventilation', 'protective ventilation with mild permissive hypercapnia', 'tidal carbon dioxide (Etco2) of 6.5 kPa (group H: mild hypercapnia, n = 8) or 5.5 kPa', 'Permissive Mild Hypercapnia']","['Cerebral vascular vasoreactivity', 'heart rate', 'THI and MAP', 'hemodynamic, respiratory, and near-infrared spectroscopy (NIRS)-derived parameters, including tissue oxygenation index (TOI) and tissue hemoglobin index (THI), concentration of deoxygenated hemoglobin (HHb) and oxygenated hemoglobin (O2Hb', 'MAP and TOI', 'cerebral perfusion', 'Cerebral Vasoreactivity', 'mean driving pressure', 'cerebral blood flow', 'driving pressure and comparable hemodynamic, respiratory, and cerebral oxygenation parameters', 'sevoflurane maintenance concentration, ventilatory (driving pressure) and hemodynamic parameters, as mean arterial pressure (MAP']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0441842', 'cui_str': 'Group H'}, {'cui': 'C3844008', 'cui_str': '5.5'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0272238', 'cui_str': 'Transient hypogammaglobulinemia of infancy'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",19.0,0.140873,"A mild decrease with time was observed in THI and MAP in infants randomly assigned to group N (P < .036 and P < .017, respectively).","[{'ForeName': 'Leonore', 'Initials': 'L', 'LastName': 'Schopfer', 'Affiliation': 'From the Pediatric Anesthesia Unit, Department of Anesthesiology, Pharmacology, Intensive Care and Emergency Medicine, University Hospitals of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Habre', 'Affiliation': 'From the Pediatric Anesthesia Unit, Department of Anesthesiology, Pharmacology, Intensive Care and Emergency Medicine, University Hospitals of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Pichon', 'Affiliation': 'From the Pediatric Anesthesia Unit, Department of Anesthesiology, Pharmacology, Intensive Care and Emergency Medicine, University Hospitals of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Gergely H', 'Initials': 'GH', 'LastName': 'Fodor', 'Affiliation': 'Unit for Anesthesiological Investigations, Department of Acute Medicine, University of Geneva, Geneva, Switzerland.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005325']
411,33410611,Comparative Effect of Propofol and Volatile Anesthetics on Postoperative Pulmonary Complications After Lung Resection Surgery: A Randomized Clinical Trial.,"BACKGROUND


The effect of general anesthetics (propofol and volatile anesthetics) on pulmonary outcome after lung resection surgery with one-lung ventilation (OLV) is yet undetermined. We evaluated the effect of intravenous anesthesia (propofol) and volatile anesthesia (sevoflurane or desflurane) regimens on postoperative pulmonary complications (PPCs) in patients undergoing lung resection surgery.
METHODS


This prospective, randomized controlled trial enrolled 555 adult patients scheduled for lung resection surgery with OLV. Participants were randomized to 1 of 3 general anesthetic regimens (propofol, sevoflurane, or desflurane). Standard anesthesia and ventilation protocols were followed in all groups. The primary outcome was a composite of PPCs in the first 7 postoperative days. Secondary outcomes included the severity of PPCs and major postoperative complications classification. Intergroup difference in the primary outcome was assessed for significance using the Pearson χ2 test.
RESULTS


Of 837 patients who were assessed for eligibility, 555 were randomized and 545 were analyzed. One hundred and seventy-nine patients were assigned to the propofol group, 182 in the sevoflurane group, and 184 in the desflurane group. The incidence of PPCs did not differ between the combined volatile anesthetics (sevoflurane and desflurane) group and the propofol group (21.9% vs 24.0%; odds ratio, 0.89; 95% confidence interval, 0.58-1.35; P = .570). The PPCs grade and Clavien-Dindo scores did not differ significantly across groups.
CONCLUSIONS


In patients undergoing lung resection surgery with OLV, general anesthesia with volatile anesthetics (sevoflurane or desflurane) did not reduce PPCs compared with propofol. No difference in secondary outcomes was observed.",2021,"The incidence of PPCs did not differ between the combined volatile anesthetics (sevoflurane and desflurane) group and the propofol group (21.9% vs 24.0%; odds ratio, 0.89; 95% confidence interval, 0.58-1.35; P = .570).","['patients undergoing lung resection surgery with OLV, general anesthesia with', 'patients undergoing lung resection surgery', 'pulmonary outcome after lung resection surgery with one-lung ventilation (OLV', '555 adult patients scheduled for lung resection surgery with OLV', 'One hundred and seventy-nine patients', '837 patients who were assessed for eligibility, 555 were randomized and 545 were analyzed', 'After Lung Resection Surgery']","['volatile anesthetics (sevoflurane and desflurane', 'desflurane', 'general anesthetics (propofol and volatile anesthetics', 'intravenous anesthesia (propofol) and volatile anesthesia (sevoflurane or desflurane', 'propofol', 'sevoflurane', 'volatile anesthetics (sevoflurane or desflurane', 'Propofol and Volatile Anesthetics', 'anesthetic regimens (propofol, sevoflurane, or desflurane']","['severity of PPCs and major postoperative complications classification', 'PPCs grade and Clavien-Dindo scores', 'postoperative pulmonary complications (PPCs', 'composite of PPCs in the first 7 postoperative days', 'Postoperative Pulmonary Complications', 'incidence of PPCs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4517810', 'cui_str': '555'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517809', 'cui_str': '545'}]","[{'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",555.0,0.112269,"The incidence of PPCs did not differ between the combined volatile anesthetics (sevoflurane and desflurane) group and the propofol group (21.9% vs 24.0%; odds ratio, 0.89; 95% confidence interval, 0.58-1.35; P = .570).","[{'ForeName': 'Xue-Fei', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'From the Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, China.'}, {'ForeName': 'Jian-Rong', 'Initials': 'JR', 'LastName': 'Hu', 'Affiliation': 'Anesthesia Operating Center, West China Hospital, Sichuan University/West China School of Nursing, Chengdu, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'From the Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'From the Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, China.'}, {'ForeName': 'Meng-Qiu', 'Initials': 'MQ', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'From the Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, China.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005334']
412,33410564,Covered self-expandable metal stents versus plastic stents for preoperative biliary drainage in patient receiving neo-adjuvant chemotherapy for borderline resectable pancreatic cancer: Prospective randomized study.,"OBJECTIVES


This single-center comparative randomized superiority study compared biliary stenting using fully covered self-expandable metal stents (FCSEMS) and biliary stenting using plastic stents (PS) in preoperative biliary drainage of patients with borderline resectable pancreatic cancer (BRPC) who are planned to undergo a single regimen of neo-adjuvant chemotherapy (NAC).
METHODS


Twenty-two patients with BRPC who required preoperative biliary drainage before NAC (Gemcitabine plus Nab-paclitaxel) were randomly assigned 1:1 to the FCSEMS or PS group. The primary endpoint was the rate of stent dysfunction until surgery or tumor progression. Secondary endpoints were stent patency, number of re-interventions, adverse events of endoscopic retrograde biliary drainage (EBD), operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs.
RESULTS


Eleven patients in each of the groups reached the primary endpoint. The FCSEMS group showed a significantly lower rate of stent dysfunction (18.2% vs. 72.8%, P = 0.015), longer stent patency (P = 0.02), and lower number of re-interventions for stent dysfunction (0.27 ± 0.65 vs. 1.27 ± 1.1, P = 0.001) than the PS group. The adverse events of EBD, operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs did not significantly differ between the two groups.
CONCLUSIONS


In patients with BRPC for preoperative biliary drainage, stent dysfunction occurred less frequently with FCSEMSs than with PSs. In addition, FCSEMS and PS provided similar preoperative management of BRPC in terms of the safety of surgery and medical costs. (UMIN ID000030473).",2021,"The FCSEMS group showed a significantly lower rate of stent dysfunction (18.2% vs. 72.8%, P = 0.015), longer stent patency (P = 0.02), and lower number of re-interventions for stent dysfunction (0.27 ± 0.65 vs. 1.27 ± 1.1, P = 0.001) than the PS group.","['patients with borderline resectable pancreatic cancer (BRPC', 'Twenty-two patients with BRPC who required preoperative biliary drainage before', 'patient receiving neo-adjuvant chemotherapy for borderline resectable pancreatic cancer']","['FCSEMS', 'NAC (Gemcitabine plus Nab-paclitaxel', 'neo-adjuvant chemotherapy (NAC', 'FCSEMS or PS', 'biliary stenting using fully covered self-expandable metal stents (FCSEMS) and biliary stenting using plastic stents (PS', 'Covered self-expandable metal stents versus plastic stents']","['longer stent patency', 'rate of stent dysfunction until surgery or tumor progression', 'rate of stent dysfunction', 'adverse events of EBD, operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs', 'preoperative biliary drainage, stent dysfunction', 'stent patency, number of re-interventions, adverse events of endoscopic retrograde biliary drainage (EBD), operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854778', 'cui_str': 'Pancreatic carcinoma resectable'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metallic Stent'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}, {'cui': 'C0183512', 'cui_str': 'Biliary stent'}]","[{'cui': 'C0449591', 'cui_str': 'Stent patency'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",22.0,0.0908098,"The FCSEMS group showed a significantly lower rate of stent dysfunction (18.2% vs. 72.8%, P = 0.015), longer stent patency (P = 0.02), and lower number of re-interventions for stent dysfunction (0.27 ± 0.65 vs. 1.27 ± 1.1, P = 0.001) than the PS group.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Itonaga', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Ashida', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Yasunobu', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Hatamaru', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kawaji', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Emori', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kitahata', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Miyazawa', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Seiko', 'Initials': 'S', 'LastName': 'Hirono', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Okada', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kawai', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University Hospital, Wakayama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaue', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kitano', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.13926']
413,33482007,Implicit and Explicit Motor Learning Interventions Have Similar Effects on Walking Speed in People After Stroke: A Randomized Controlled Trial.,"OBJECTIVE


Clinicians may use implicit or explicit motor learning approaches to facilitate motor learning of patients with stroke. Implicit motor learning approaches have shown promising results in healthy populations. The purpose of this study was to assess whether an implicit motor learning walking intervention is more effective compared with an explicit motor learning walking intervention delivered at home regarding walking speed in people after stroke in the chronic phase of recovery.
METHODS


This randomized, controlled, single-blind trial was conducted in the home environment. The 79 participants, who were in the chronic phase after stroke (age = 66.4 [SD = 11.0] years; time poststroke = 70.1 [SD = 64.3] months; walking speed = 0.7 [SD = 0.3] m/s; Berg Balance Scale score = 44.5 [SD = 9.5]), were randomly assigned to an implicit (n = 38) or explicit (n = 41) group. Analogy learning was used as the implicit motor learning walking intervention, whereas the explicit motor learning walking intervention consisted of detailed verbal instructions. Both groups received 9 training sessions (30 minutes each), for a period of 3 weeks, targeted at improving quality of walking. The primary outcome was walking speed measured by the 10-Meter Walk Test at a comfortable walking pace. Outcomes were assessed at baseline, immediately after intervention, and 1 month postintervention.
RESULTS


No statistically or clinically relevant differences between groups were obtained postintervention (between-group difference was estimated at 0.02 m/s [95% CI = -0.04 to 0.08] and at follow-up (between-group difference estimated at -0.02 m/s [95% CI = -0.09 to 0.05]).
CONCLUSION


Implicit motor learning was not superior to explicit motor learning to improve walking speed in people after stroke in the chronic phase of recovery.
IMPACT


To our knowledge, this is the first study to examine the effects of implicit compared with explicit motor learning on a functional task in people after stroke. Results indicate that physical therapists can use (tailored) implicit and explicit motor learning strategies to improve walking speed in people after stroke who are in the chronic phase of recovery.",2021,"CONCLUSIONS


Implicit motor learning was not superior to explicit motor learning to improve walking speed in people after stroke in the chronic phase of recovery.
","['healthy populations', '79 participants, who were in the chronic phase after stroke (age\xa0=\xa066.4', 'patients with stroke', 'People', 'people after stroke']","['implicit motor learning walking intervention', 'explicit motor learning walking intervention', 'explicit motor learning', 'explicit motor learning walking intervention consisted of detailed verbal instructions', 'Implicit motor learning approaches', 'Implicit and Explicit Motor Learning Interventions']","['walking speed', 'walking speed measured by the 10-Meter Walk Test at a comfortable walking pace', 'Walking Speed']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]",,0.141739,"CONCLUSIONS


Implicit motor learning was not superior to explicit motor learning to improve walking speed in people after stroke in the chronic phase of recovery.
","[{'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Jie', 'Affiliation': 'Research Centre for Nutrition, Lifestyle and Exercise, Zuyd University of Applied Sciences, Heerlen, Netherlands.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Kleynen', 'Affiliation': 'Research Centre for Nutrition, Lifestyle and Exercise, Zuyd University of Applied Sciences, Heerlen, Netherlands.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Meijer', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Beurskens', 'Affiliation': 'Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Susy', 'Initials': 'S', 'LastName': 'Braun', 'Affiliation': 'Research Centre for Nutrition, Lifestyle and Exercise, Zuyd University of Applied Sciences, Heerlen, Netherlands.'}]",Physical therapy,['10.1093/ptj/pzab017']
414,33427754,The Effect of a Continuous Milk Warming System on Weight Gain in Very Low Birth-Weight Infants: A Randomized Controlled Trial.,"BACKGROUND


Few studies support the practice of warming human milk before feeding. No studies have compared the method of warming milk and its effect on growth, particularly in preterm infants.
PURPOSE


To evaluate growth in preterm infants receiving continuously warmed human milk as compared with infants receiving human milk warmed in a hot water bath before feeding.
METHODS


Forty-four infants less than 32 weeks' gestation admitted to a regional referral level IV neonatal intensive care unit in south central United States were randomly assigned to either the experimental group (continuous warming: n = 22) or the control group (hot water bath: n =22) for 10 days. All infants were on full human milk feedings (120-130 kcal/kg/d) as part of a standardized feeding protocol. Tolerance and weight gain over the 10-day period were used to evaluate the effectiveness of continuous milk warming.
RESULTS


There was a significant difference in weight gain for infants receiving continuously warmed milk compared with infants receiving standard warmed milk (203.73 ± 70.71 vs 271.95 ± 67.40, P = .002).
IMPLICATIONS FOR PRACTICE


The use of continuous milk warming improves weight gain in very low birth-weight infants.",2021,"There was a significant difference in weight gain for infants receiving continuously warmed milk compared with infants receiving standard warmed milk (203.73 ± 70.71 vs 271.95 ± 67.40, P = .002).
","['preterm infants', ""Forty-four infants less than 32 weeks' gestation admitted to a regional referral level IV neonatal intensive care unit in south central United States"", 'Very Low Birth-Weight Infants', 'preterm infants receiving continuously warmed human milk as compared with infants receiving human milk warmed in a hot water bath before feeding', 'very low birth-weight infants']","['continuous milk warming', 'Continuous Milk Warming System']","['weight gain', 'Tolerance and weight gain', 'Weight Gain']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0337023', 'cui_str': 'Hot water'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",,0.087684,"There was a significant difference in weight gain for infants receiving continuously warmed milk compared with infants receiving standard warmed milk (203.73 ± 70.71 vs 271.95 ± 67.40, P = .002).
","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Bedwell', 'Affiliation': ""Neonatal Services, The Children's Hospital, Oklahoma City, Oklahoma (Dr Bedwell and Ms Buster); and Perinatal-Neonatal Services, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma (Dr Sekar).""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Buster', 'Affiliation': ''}, {'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': ''}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000818']
415,33417105,Associations of Father and Adult Male Presence with First Pregnancy and HIV Infection: Longitudinal Evidence from Adolescent Girls and Young Women in Rural South Africa (HPTN  068).,"This study, a secondary analysis of the HPTN 068 randomized control trial, aimed to quantify the association of father and male presence with HIV incidence and first pregnancy among 2533 school-going adolescent girls and young women (AGYW) in rural South Africa participating in the trial between March 2011 and April 2017. Participants' ages ranged from 13-20 years at study enrollment and 17-25 at the post-intervention visit. HIV and pregnancy incidence rates were calculated for each level of the exposure variables using Poisson regression, adjusted for age using restricted quadratic spline variables, and, in the case of pregnancy, also adjusted for whether the household received a social grant. Our study found that AGYW whose fathers were deceased and adult males were absent from the household were most at risk for incidence of first pregnancy and HIV (pregnancy: aIRR = 1.30, Wald 95% CI 1.05, 1.61, Wald chi-square p = 0.016; HIV: aIRR = 1.27, Wald 95% CI 0.84, 1.91, Wald chi-square p = 0.263) as compared to AGYW whose biological fathers resided with them. For AGYW whose fathers were deceased, having other adult males present as household members seemed to attenuate the incidence (pregnancy: aIRR = 0.92, Wald 95% CI 0.74, 1.15, Wald chi-square p = 0.462; HIV: aIRR = 0.90, Wald 95% CI 0.58, 1.39, Wald chi-square p = 0.623) such that it was similar, and therefore not statistically significantly different, to AGYW whose fathers were present in the household.",2021,"HIV: aIRR = 1.27, Wald 95% CI 0.84, 1.91, Wald chi-square p = 0.263) as compared to AGYW whose biological fathers resided with them.","['fathers were deceased and adult males', 'father and male presence with HIV incidence and first pregnancy among 2533 school-going adolescent girls and young women (AGYW) in rural South Africa participating in the trial between March 2011 and April 2017', 'Adolescent Girls and Young Women in Rural South Africa (HPTN \xa0068', ""Participants' ages ranged from 13-20\xa0years at study enrollment and 17-25 at the post-intervention visit""]",[],['HIV and pregnancy incidence rates'],"[{'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0860096', 'cui_str': 'Primigravida'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0663049,"HIV: aIRR = 1.27, Wald 95% CI 0.84, 1.91, Wald chi-square p = 0.263) as compared to AGYW whose biological fathers resided with them.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Albert', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7435, USA. Lisamariealbert@gmail.com.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7435, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pence', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7435, USA.'}, {'ForeName': 'Ilene S', 'Initials': 'IS', 'LastName': 'Speizer', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hillis', 'Affiliation': 'National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kahn', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Unit, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Gómez-Olivé', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Unit, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Wagner', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Unit, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Twine', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Unit, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7435, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03147-y']
416,33484221,A psychosocial intervention for individuals with advanced chronic kidney disease: A feasibility randomized controlled trial.,"AIM


The current study evaluated the feasibility and preliminary efficacy of a psychosocial intervention, the Kidney Optimal Health Program, in reducing symptoms of depression and anxiety in individuals with advanced chronic kidney disease.
METHODS


Patients with stage 4 or 5 chronic kidney disease were randomized to either a nine-session psychosocial intervention programme or usual care. Feasibility was assessed through recruitment and retention rates and programme acceptability. Participants completed assessments of depression, anxiety and psychosocial health at baseline and at 3-, 6- and 12-month follow-up. A repeated-measures analysis of variance was used to compare groups on outcomes over time.
RESULTS


One hundred and twenty-eight patients were screened for eligibility; 84 consented to participant and were randomized to receive the intervention (N = 42) or usual care (N = 42). 27 (32.1%) participants withdrew prior to baseline assessment. Of those who completed the baseline assessment (N = 57), trial retention was high (75.4% at 3-month, 80.7% at 6-month and 70.2% at 12-month follow-up). Participants reported high levels of programme acceptability. The patients who completed the intervention (N = 17) demonstrated significantly decreased depression at 12-month follow-up compared to the usual care group (N = 13).
CONCLUSION


The results support the feasibility of the Kidney Optimal Health Program intervention in recruitment, retention and programme acceptability with an improved screening protocol. Preliminary support is provided for improvement in depressive symptoms in patients with advanced chronic kidney disease. Further investigation through a fully powered randomized controlled trial is warranted.",2021,"The patients who completed the intervention (N=17) demonstrated significantly decreased depression at 12-month follow-up compared to the usual care group (N=13).
","['Patients with stage 4 or 5 chronic kidney disease', '128 patients were screened for eligibility; 84 consented to participant', 'individuals with advanced chronic kidney disease', 'patients with advanced chronic kidney disease']","['nine-session psychosocial intervention program or usual care', 'usual care', 'psychosocial intervention, the Kidney Optimal Health Program', 'psychosocial intervention']","['high levels of program acceptability', 'retention and program acceptability', 'depression, anxiety and psychosocial health', 'trial retention', 'depressive symptoms', 'recruitment and retention rates and program acceptability', 'depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]",128.0,0.07546,"The patients who completed the intervention (N=17) demonstrated significantly decreased depression at 12-month follow-up compared to the usual care group (N=13).
","[{'ForeName': 'Zoe M', 'Initials': 'ZM', 'LastName': 'Jenkins', 'Affiliation': ""Mental Health Service, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Tan', 'Affiliation': ""Mental Health Service, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Emmet', 'Initials': 'E', 'LastName': ""O'Flaherty"", 'Affiliation': ""Department of Nephrology, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Knowles', 'Affiliation': ""Mental Health Service, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thompson', 'Affiliation': 'Department of Psychiatry, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Chantal F', 'Initials': 'CF', 'LastName': 'Ski', 'Affiliation': 'Department of Psychiatry, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Rossell', 'Affiliation': ""Mental Health Service, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Carolee', 'Initials': 'C', 'LastName': 'Coco', 'Affiliation': ""Mental Health Service, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Francesco L', 'Initials': 'FL', 'LastName': 'Ierino', 'Affiliation': ""Department of Nephrology, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Hilton', 'Initials': 'H', 'LastName': 'Gock', 'Affiliation': ""Department of Nephrology, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Castle', 'Affiliation': ""Mental Health Service, St. Vincent's Hospital, Melbourne, Australia.""}]","Nephrology (Carlton, Vic.)",['10.1111/nep.13850']
417,33426938,Clinical outcome of cardiac resynchronization therapy in patients randomized to an active fixation bipolar left ventricular lead  versus  a passive quadripolar lead.,"Objectives:  To compare the clinical outcome of cardiac resynchronization therapy (CRT) in patients receiving a bipolar left ventricular (LV) lead with a side helix for active fixation to the outcome in patients receiving a quadripolar passive fixation LV lead. Design:  Sixty-two patients (mean age 72 ± 11 years) were blindly and randomly assigned to the active fixation bipolar lead group ( n  = 31) or to the quadripolar lead group ( n = 31). The LV leads were targeted to the basal LV segment in a vein concordant to the LV segment with the latest mechanical contraction chosen on the basis of preoperative radial strain (RS) echocardiography. Results:  At the 6-month follow-up (FU), the reduction in LV end-systolic volume and LV reverse remodelling responder rate, defined as LV end-systolic volume reduction >15%, was 77% in the active fixation group and 83% in the quadripolar group, which was not significantly different. At the 12-month FU, the LV ejection fraction (LVEF) did not differ between the groups. There were no significant differences between the two groups in changes in New York Heart Association (NYHA) functional class or Minnesota Living with Heart Failure Questionnaire score. The occurrence of phrenic nerve stimulation (PNS) was 19% in the active fixation group versus 10% in the quadripolar group ( p =.30), and all cases were resolved by reprogramming the device. All patients were alive at the 12-month FU. There was no device infection. Conclusions:  There were no significant differences between the active fixation group of patients and the quadripolar group of patients concerning improvement in echocardiographic parameters or clinical symptoms.ClinicalTrials.gov number, NCT04632472.",2021,There were no significant differences between the active fixation group of patients and the quadripolar group of patients concerning improvement in echocardiographic parameters or clinical symptoms.,"['patients receiving a bipolar left ventricular (LV) lead with a side helix for active fixation to the outcome in patients receiving a quadripolar passive fixation LV lead', 'Sixty-two patients (mean age 72\u2009±', '11\xa0years']","['active fixation bipolar left ventricular lead  versus  a passive quadripolar lead', 'active fixation bipolar lead group ( n \u2009=\u200931) or to the quadripolar lead group', 'cardiac resynchronization therapy (CRT', 'cardiac resynchronization therapy']","['LV ejection fraction (LVEF', 'New York Heart Association (NYHA) functional class or Minnesota Living with Heart Failure Questionnaire score', 'echocardiographic parameters or clinical symptoms', 'reduction in LV end-systolic volume and LV reverse remodelling responder rate, defined as LV end-systolic volume reduction', 'occurrence of phrenic nerve stimulation (PNS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018882', 'cui_str': 'Helix'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}]","[{'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0206417', 'cui_str': 'Peripheral nervous system structure'}]",,0.0401245,There were no significant differences between the active fixation group of patients and the quadripolar group of patients concerning improvement in echocardiographic parameters or clinical symptoms.,"[{'ForeName': 'Havard', 'Initials': 'H', 'LastName': 'Keilegavlen', 'Affiliation': 'Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schuster', 'Affiliation': 'Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hovstad', 'Affiliation': 'Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Faerestrand', 'Affiliation': 'Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.'}]",Scandinavian cardiovascular journal : SCJ,['10.1080/14017431.2020.1869299']
418,33432670,Neural changes in youth at high risk for bipolar disorder undergoing family-focused therapy or psychoeducation.,"BACKGROUND


Patients with mood disorders may benefit from psychosocial interventions through changes in brain networks underlying emotion processing. In this study, we used functional magnetic resonance imaging (fMRI) to investigate treatment-related changes in emotion processing networks in youth at familial high risk for bipolar disorder (BD).
METHODS


Youth, ages 9-17, were randomly assigned to family-focused therapy for high-risk youth (FFT-HR) or an active comparison treatment, Enhanced Care (EC). Before and after these 4-month treatments, participants underwent fMRI while viewing happy, fearful, and calm facial expressions. Twenty youth in FFT-HR and 20 in EC were included in analyses of pre- to post-treatment changes in activation across the whole brain. Significant clusters were assessed for correlation with mood symptom improvement.
RESULTS


In the dorsolateral prefrontal cortex (DLPFC), activation increased from pre- to post-treatment in the FFT-HR group and decreased in the EC group. Insula activation decreased in the FFT-HR group and did not change in the EC group. Across both treatments, decreasing activation in the hippocampus and amygdala was correlated with pre- to post-treatment improvement in hypomania, while increasing activation in the DLPFC was correlated with pre- to post-treatment improvement in depression.
DISCUSSION


Psychosocial treatment addresses abnormalities in emotion regulation networks in youth at high risk for BD. Increased prefrontal cortex activation suggests enhanced emotion regulation from pre- to post-treatment with FFT-HR. Improvements in family interactions may facilitate the development of prefrontal resources that provide protection against future mood episodes.",2021,"In the dorsolateral prefrontal cortex (DLPFC), activation increased from pre- to post-treatment in the FFT-HR group and decreased in the EC group.","['youth at high risk for BD', 'Twenty youth in FFT-HR and 20 in EC', 'Youth, ages 9-17', 'youth at familial high risk for bipolar disorder (BD', 'Patients with mood disorders']","['functional magnetic resonance imaging (fMRI', 'family-focused therapy for high-risk youth (FFT-HR) or an active comparison treatment, Enhanced Care (EC']","['emotion regulation', 'Insula activation', 'dorsolateral prefrontal cortex (DLPFC), activation', 'mood symptom improvement']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0374845,"In the dorsolateral prefrontal cortex (DLPFC), activation increased from pre- to post-treatment in the FFT-HR group and decreased in the EC group.","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Garrett', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private practice, Palo Alto, CA, USA.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Casey C', 'Initials': 'CC', 'LastName': 'Armstrong', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles School of Medicine, Los Angeles, CA, USA.'}]",Bipolar disorders,['10.1111/bdi.13045']
419,33433847,Effect of Danhong Injection () on Improving Coronary Microcirculation Injury after Percutaneous Coronary Intervention.,"OBJECTIVE


To explore the effectiveness of Danhong Injection () on improving microcirculatory injury after percutaneous coronary intervention (PCI) in patients with coronary heart disease (CHD).
METHODS


A randomized controlled trial was conducted and 90 patients were enrolled. A random sequence was generated using statistical analysis software. Patients with microcirculatory injuries after PCI were randomly divided into 3 groups for treatment (30 subjects in each group): Danhong Injection group: after PCI, Danghong Injections were given with intravenous administration with 40 mL twice a day for a week; statins intensive group: after PCI, atorvastatin calcium tablets were given oral medication with 80 mg once, and then atorvastatin 40 mg daily for 1 week; the control group: after PCI, atorvastatin calcium tablets were given oral medication with 10-20 mg daily for 1 week. The index of microcirculation resistance (IMR) was used to assess microcirculatory injury during PCI. The IMR of the target vessel was reexamined after 1 week of drug treatment.
RESULTS


After one week's drug treatment, IMR was significantly decreased in both statins intensive group and Danhong Injection group compared with the control group (P<0.01), but no difference was found between statins intensive group and Danhong injection group (14.03 ± 2.54 vs. 16.03 ± 5.72 U, P=0.080).
CONCLUSIONS


The efficacy of Danhong Injection is non-inferior to statin. Early use of Danhong Injection after PCI can effectively improve coronary microcirculation injury after PCI.",2021,"After one week's drug treatment, IMR was significantly decreased in both statins intensive group and Danhong Injection group compared with the control group (P<0.01), but no difference was found between statins intensive group and Danhong injection group (14.03 ± 2.54 vs. 16.03 ± 5.72 U, P=0.080).
","['Patients with microcirculatory injuries after PCI', 'patients with coronary heart disease (CHD', 'Coronary Microcirculation Injury after Percutaneous Coronary Intervention', '90 patients were enrolled']","['PCI, atorvastatin calcium tablets', 'percutaneous coronary intervention (PCI', 'Danhong Injection after PCI', 'Danhong Injection', 'Danhong Injection ', 'atorvastatin 40 mg daily for 1 week', 'PCI, Danghong Injections']","['IMR', 'coronary microcirculation injury', 'index of microcirculation resistance (IMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0286650', 'cui_str': 'Atorvastatin calcium'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C2715773', 'cui_str': 'danhong'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",90.0,0.0439942,"After one week's drug treatment, IMR was significantly decreased in both statins intensive group and Danhong Injection group compared with the control group (P<0.01), but no difference was found between statins intensive group and Danhong injection group (14.03 ± 2.54 vs. 16.03 ± 5.72 U, P=0.080).
","[{'ForeName': 'Qing-Rong', 'Initials': 'QR', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Fuwai Hospital of Chinese Academy of Medical Sciences, Beijing, 100037, China.'}, {'ForeName': 'Hong-Xu', 'Initials': 'HX', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Wen-Long', 'Initials': 'WL', 'LastName': 'Xing', 'Affiliation': 'Department of Cardiology, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Hong-Liang', 'Initials': 'HL', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Fuwai Hospital of Chinese Academy of Medical Sciences, Beijing, 100037, China.'}, {'ForeName': 'Hai-Tong', 'Initials': 'HT', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Fuwai Hospital of Chinese Academy of Medical Sciences, Beijing, 100037, China.'}, {'ForeName': 'Guang-Yuan', 'Initials': 'GY', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology, Fuwai Hospital of Chinese Academy of Medical Sciences, Beijing, 100037, China.'}, {'ForeName': 'Yong-Jian', 'Initials': 'YJ', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Fuwai Hospital of Chinese Academy of Medical Sciences, Beijing, 100037, China. yongjianwu_nccd@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-2853-4']
420,33435877,"Feasibility and acceptability of a technology-based, rural weight management intervention in older adults with obesity.","BACKGROUND


Older adults with obesity residing in rural areas have reduced access to weight management programs. We determined the feasibility, acceptability and preliminary outcomes of an integrated technology-based health promotion intervention in rural-living, older adults using remote monitoring and synchronous video-based technology.
METHODS


A 6-month, non-randomized, non-blinded, single-arm study was conducted from October 2018 to May 2020 at a community-based aging center of adults aged ≥65 years with a body mass index (BMI) ≥30 kg/m 2 . Weekly dietitian visits focusing on behavior therapy and caloric restriction and twice-weekly physical therapist-led group strength, flexibility and balance training classes were delivered using video-conferencing to participants in their homes. Participants used a Fitbit Alta HR for remote monitoring with data feedback provided by the interventionists. An aerobic activity prescription was provided and monitored.
RESULTS


Mean age was 72.9±3.9 years (82% female). Baseline anthropometric measures of weight, BMI, and waist circumference were 97.8±16.3 kg, 36.5±5.2 kg/m 2 , and 115.5±13.0 cm, respectively. A total of 142 participants were screened (n=27 ineligible), and 53 consented. There were nine dropouts (17%). Overall satisfaction with the trial (4.7+ 0.6, scale: 1 (low) to 5 (high)) and with Fitbit (4.2+ 0.9) were high. Fitbit was worn an average of 81.7±19.3% of intervention days. In completers, mean weight loss was 4.6±3.5 kg or 4.7±3.5% (p< 0.001). Physical function measures of 30-s sit-to-stand repetitions increased from 13.5±5.7 to 16.7±5.9 (p< 0.001), 6-min walk improved by 42.0±77.3 m (p=0.005) but no differences were observed in gait speed or grip strength. Subjective measures of late-life function improved (3.4±4.7 points, p< 0.001).
CONCLUSIONS


A technology-based obesity intervention is feasible and acceptable to older adults with obesity and may lead to weight loss and improved physical function.
CLINICAL TRIAL REGISTRATION


Registered on Clinicaltrials.gov # NCT03104205 . Registered on April 7, 2017. First participant enrolled on October 1st, 2018.",2021,"Subjective measures of late-life function improved (3.4±4.7 points, p< 0.001).
","['Mean age was 72.9±3.9\u2009years (82% female', 'Older adults with obesity residing in rural areas', 'rural-living, older adults using', '142 participants were screened (n=27 ineligible), and 53 consented', 'older adults with obesity', 'A 6-month, non-randomized, non-blinded, single-arm study was conducted from October 2018 to May 2020 at a community-based aging center of adults aged ≥65\u2009years with a body mass index (BMI) ≥30\u2009kg/m 2 ']","['technology-based, rural weight management intervention', 'technology-based obesity intervention', 'remote monitoring and synchronous video-based technology', 'integrated technology-based health promotion intervention', 'Weekly dietitian visits focusing on behavior therapy and caloric restriction and twice-weekly physical therapist-led group strength, flexibility and balance training classes were delivered using video-conferencing to participants in their homes']","['mean weight loss', 'Feasibility and acceptability', 'Physical function measures of 30-s sit-to-stand repetitions', 'Baseline anthropometric measures of weight, BMI, and waist circumference', '6-min walk', 'Subjective measures of late-life function', 'Overall satisfaction', 'gait speed or grip strength']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}]",142.0,0.0630395,"Subjective measures of late-life function improved (3.4±4.7 points, p< 0.001).
","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Batsis', 'Affiliation': 'Division of Geriatric Medicine, School of Medicine, and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 5017 Old Clinic Building, Chapel Hill, NC, 27599, USA. john.batsis@gmail.com.'}, {'ForeName': 'Curtis L', 'Initials': 'CL', 'LastName': 'Petersen', 'Affiliation': 'Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Mayo Clinic Rochester, Department of Psychiatry and Psychology, and Division of Endocrinology, Rochester, MN, USA.'}, {'ForeName': 'Summer B', 'Initials': 'SB', 'LastName': 'Cook', 'Affiliation': 'University of New Hampshire, Durham, NH, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kotz', 'Affiliation': 'Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Tyler L', 'Initials': 'TL', 'LastName': 'Gooding', 'Affiliation': 'Dartmouth-Hitchcock, Geisel School of Medicine, and The Dartmouth Institute for Health Policy, Hanover, NH, USA.'}, {'ForeName': 'Meredith N', 'Initials': 'MN', 'LastName': 'Roderka', 'Affiliation': 'Dartmouth-Hitchcock, Geisel School of Medicine, and The Dartmouth Institute for Health Policy, Hanover, NH, USA.'}, {'ForeName': 'Rima I', 'Initials': 'RI', 'LastName': 'Al-Nimr', 'Affiliation': 'Dartmouth-Hitchcock, Geisel School of Medicine, and The Dartmouth Institute for Health Policy, Hanover, NH, USA.'}, {'ForeName': 'Dawna', 'Initials': 'D', 'LastName': 'Pidgeon', 'Affiliation': 'Dartmouth-Hitchcock, Geisel School of Medicine, and The Dartmouth Institute for Health Policy, Hanover, NH, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Haedrich', 'Affiliation': 'Dartmouth-Hitchcock, Geisel School of Medicine, and The Dartmouth Institute for Health Policy, Hanover, NH, USA.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Wright', 'Affiliation': 'Dartmouth-Hitchcock, Geisel School of Medicine, and The Dartmouth Institute for Health Policy, Hanover, NH, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Aquila', 'Affiliation': 'Dartmouth-Hitchcock, Geisel School of Medicine, and The Dartmouth Institute for Health Policy, Hanover, NH, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Mackenzie', 'Affiliation': 'Dartmouth College, Hanover, NH, USA.'}]",BMC geriatrics,['10.1186/s12877-020-01978-x']
421,33435760,Adopting an alternative structure for clinical trials in immunotherapy.,"Background:  This evaluation emphasizes the main points of the original article 'Position paper: new insights into the immunobiology and dynamics of tumor-host interactions require adaptations of clinical studies' by Sprenger et al. and provides further justification for the use of an alternative approach in the design of human clinical trials for new investigational drugs in the field of immuno-oncology. Objective:  Standard trial design utilizing the double blind placebo trial approach, while effective for drugs that directly treat tumors, is too costly, slow, and not effective for drugs and protocols that depend on activation of the immune system for killing of tumors. Methods/results:  This paper has proposed through the use of detailed diagnostic profiling, small groups of patients with similar tumor microenvironment characteristics be grouped to determine the clinical benefit of immunological combinations that enter clinical trials. In addition, mega data from larger trials in which patients are subcategorized as above can provide the necessary data as a substitute for current double blind placebo trials which do not take into account the immune status of the host and tumor. Conclusion:  There needs to be evolution of the clinical trial landscape so that it matches the exponential growth of the field of immunotherapy.",2021,This evaluation emphasizes the main points of the original article 'Position paper: new insights into the immunobiology and dynamics of tumor-host interactions require adaptations of clinical studies' by Sprenger et al. and provides further justification for the use of an alternative approach in the design of human clinical trials for new investigational drugs in the field of immuno-oncology.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.399534,This evaluation emphasizes the main points of the original article 'Position paper: new insights into the immunobiology and dynamics of tumor-host interactions require adaptations of clinical studies' by Sprenger et al. and provides further justification for the use of an alternative approach in the design of human clinical trials for new investigational drugs in the field of immuno-oncology.,"[{'ForeName': 'Evanthia T', 'Initials': 'ET', 'LastName': 'Roussos Torres', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Epstein', 'Affiliation': 'Department of Pathology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]",Expert review of anticancer therapy,['10.1080/14737140.2021.1875822']
422,33438238,Effects of biological determinist and interactionist causal explanations on undergraduate students' stigma of children with attention deficits hyperactivity disorders: An experimental investigation.,"This experimental study examined the effects of biological explanations on individuals' stigma against children with ADHD. We randomly assigned 174 undergraduate students to read one of the three fictitious articles: the first article focused on the determining role of biology in affecting children's ADHD symptoms (biological determinist), the second article highlighted the interplay between biological and environmental factors (interactionist), and the third article was unrelated to ADHD (control). Analyses of variance showed that participants who read the biological determinist message, relative to the control group, were (a) less likely to blame the children for their problems, but (b) more likely to endorse fixed beliefs about the nature of ADHD (entity beliefs). Thus, the overall direct effect of biological determinist message on desire for social distance was not significant. By contrast, participants who read the interactionist message showed (a) less blame attribution and (b) lower levels of entity beliefs, which contributed to less desire for social distance. These findings suggest that (a) presenting biological information regarding ADHD in a deterministic way may not be an effective way to reduce stigma, whereas (b) providing an interactionist account of ADHD may undermine the potential negative effect of an exclusively biological explanation.",2021,"Analyses of variance showed that participants who read the biological determinist message, relative to the control group, were (a) less likely to blame the children for their problems, but (b) more likely to endorse fixed beliefs about the nature of ADHD (entity beliefs).","[""undergraduate students' stigma of children with attention deficits hyperactivity disorders"", ""individuals' stigma against children with ADHD"", '174 undergraduate students to read one of the three fictitious articles']",['biological determinist and interactionist causal explanations'],['blame attribution and (b) lower levels of entity beliefs'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",174.0,0.017369,"Analyses of variance showed that participants who read the biological determinist message, relative to the control group, were (a) less likely to blame the children for their problems, but (b) more likely to endorse fixed beliefs about the nature of ADHD (entity beliefs).","[{'ForeName': 'Boby Ho-Hong', 'Initials': 'BH', 'LastName': 'Ching', 'Affiliation': 'Faculty of Education, University of Macau, Taipa, Macau.'}, {'ForeName': 'Terrence Cheok In', 'Initials': 'TCI', 'LastName': 'Ma', 'Affiliation': 'Faculty of Education, University of Macau, Taipa, Macau.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12738']
423,33450164,"A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease.","Purpose:  To determine whether reproxalap, a novel reactive aldehyde species (RASP) inhibitor, is safe and effective for the treatment of the signs and symptoms of dry eye disease (DED).  Methods:  In a randomized double-masked parallel-group Phase 2a trial of 3 topical ocular reproxalap formulations (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid ophthalmic solution), 51 patients with DED were randomly assigned 1:1:1 at a single US site. Eyes were treated bilaterally 4 times daily for 28 days, and standard DED signs and symptoms were assessed at baseline and after 7 and 28 days of dosing. Tear RASP levels were assessed at baseline and at day 28.  Results:  The effect of treatment on DED signs and symptoms was similar across the treatment arms, and pooled data from the 28-day treatment period demonstrated significant improvement from baseline in Symptom Assessment in Dry Eye Disease score ( P  = 0.003), Ocular Discomfort Scale score ( P  < 0.0001), Ocular Discomfort Score and 4-Symptom Questionnaire overall score ( P  = 0.0004), Schirmer's test ( P  = 0.008), tear osmolarity ( P  = 0.003), and lissamine green total staining score ( P  = 0.002). Improvements in DED symptoms were evident within 1 week of therapy, and effect sizes generally approached or exceeded 0.5. No significant changes in safety measures were observed.  Conclusion:  The results suggest that the novel RASP inhibitor reproxalap has the potential to mitigate the signs and symptoms of DED, and may represent a new, rapidly and broadly active treatment approach for DED (NCT03162783).",2021,No significant changes in safety measures were observed.  ,['51 patients with DED'],"['Topical Ocular Reproxalap', 'reproxalap', 'topical ocular reproxalap formulations (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid ophthalmic solution']","['Ocular Discomfort Score and 4-Symptom Questionnaire overall score', 'DED symptoms', 'tear osmolarity', 'safety measures', 'Ocular Discomfort Scale score', 'lissamine green total staining score', 'Tear RASP levels', 'DED signs and symptoms', 'Symptom Assessment in Dry Eye Disease score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]","[{'cui': 'C0948595', 'cui_str': 'Ocular discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0995147', 'cui_str': 'Rasp'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]",51.0,0.353959,No significant changes in safety measures were observed.  ,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Aldeyra Therapeutics, Lexington, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sheppard', 'Affiliation': 'Virginia Eye Consultants, Norfolk, Virginia, USA.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Brady', 'Affiliation': 'Aldeyra Therapeutics, Lexington, Massachusetts, USA.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2020.0087']
424,33411115,Renal prognoses by different target hemoglobin levels achieved by epoetin beta pegol dosing to chronic kidney disease patients with hyporesponsive anemia to erythropoiesis-stimulating agent: a multicenter open-label randomized controlled study.,"BACKGROUND


There is no evidence regarding appropriate target hemoglobin levels in chronic kidney disease (CKD) patients with an erythropoiesis-stimulating agent (ESA)-hyporesponsiveness. Therefore, we conducted a randomized controlled study in non-dialysis dependent CKD (NDD-CKD) patients with ESA-hyporesponsiveness, comparing results of intensive versus conservative treatment to maintain hemoglobin levels.
METHODS


This was a multicenter, open-label, randomized, parallel-group study conducted at 89 institutions. Among NDD-CKD patients, those with ESA-hyporesponsive renal anemia were randomly assigned to an intensive treatment group, to which epoetin beta pegol was administered with target hemoglobin level of 11 g/dL or higher, or conservative treatment group, in which the hemoglobin levels at enrollment (within ± 1 g/dL) were maintained. The primary endpoint was the time to the first kidney composite event defined as (1) transition to renal replacement therapy (dialysis or renal transplantation); (2) reduction of estimated glomerular filtration rate (eGFR) to less than 6.0 mL/min/1.73 m 2 ; or (3) reduction of eGFR by 30% or more. Secondary endpoints were kidney function (change rate in eGFR), cardiovascular (CV) events, and safety.
RESULTS


Between August 2012 and December 2015, 385 patients were registered, and 362 patients who met the eligibility criteria were enrolled. There was no significant difference in kidney survival or in CV events between the two groups. However, the incidences of the 3 types of kidney composite events tended to differ.
CONCLUSIONS


In NDD-CKD patients with ESA-hyporesponsive renal anemia, the aggressive administration of ESA did not clearly extend kidney survival or result in a significant difference in the incidence of CV events.",2021,There was no significant difference in kidney survival or in CV events between the two groups.,"['89 institutions', '362 patients who met the eligibility criteria were enrolled', 'Between August 2012 and December 2015, 385 patients were registered, and', 'non-dialysis dependent CKD (NDD-CKD) patients with ESA-hyporesponsiveness', 'NDD-CKD patients, those with ESA-hyporesponsive renal anemia', 'chronic kidney disease (CKD) patients with an erythropoiesis-stimulating agent (ESA)-hyporesponsiveness']","['ESA', 'epoetin beta pegol was administered with target hemoglobin level of 11\xa0g/dL or higher, or conservative treatment', 'erythropoiesis-stimulating agent', 'epoetin beta pegol']","['kidney survival', 'kidney function (change rate in eGFR), cardiovascular (CV) events, and safety', 'eGFR', 'incidence of CV events', 'kidney survival or in CV events', 'time to the first kidney composite event defined as (1) transition to renal replacement therapy (dialysis or renal transplantation); (2) reduction of estimated glomerular filtration rate (eGFR', 'kidney composite events']","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1142276', 'cui_str': 'Renal anemia'}]","[{'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1328071', 'cui_str': 'Methoxy polyethylene glycol-epoetin beta'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",385.0,0.0272579,There was no significant difference in kidney survival or in CV events between the two groups.,"[{'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Tsuruya', 'Affiliation': 'Department of Nephrology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan. tsuruya@naramed-u.ac.jp.'}, {'ForeName': 'Terumasa', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Kidney Disease and Hypertension, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hase', 'Affiliation': 'Aoba Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Nishi', 'Affiliation': 'Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Yamagata', 'Affiliation': 'Division of Clinical Medicine, Department of Nephrology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': 'Division of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Nephrology and Laboratory Medicine, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hirakata', 'Affiliation': 'Fukuoka Renal Clinic, Fukuoka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical and experimental nephrology,['10.1007/s10157-020-02005-4']
425,33427129,The use of biofeedback intervention in the improvement of depression levels: a randomised trial.,"OBJECTIVE


To evaluate the use of biofeedback intervention in the levels of depression. The main hypothesis tested if the use of biofeedback improves depression levels compared to the control group.
METHODS


A randomised clinical trial. The final sample was composed of 36 participants (18 in the experimental group, receiving 6 training, once a week, with biofeedback; and 18 in the control group, who received conventional treatment in the service).Outcome measures were assessed in two stages: pre-test and post-test. The research used the following instruments: demographic survey data, Mini International Neuropsychiatric Interview 5.0.0 and Beck Depression Inventory (BDI). The factors and variables were presented in terms of descriptive and inferential statistics. Fisher's exact test (p < 0.05) was used to verify the existence of an association between the counting variables. The multinomial logistic regression model was adopted, and the Logit link function was used, as the software RStudio version 3.6.2.
RESULTS


The factors that remained in the final model were group, sex, partner, atypical antidepressant, benzodiazepines, mood stabiliser, antiepileptic and antihistamine, according to the levels of depression based on the BDI. The group that did not receive biofeedback intervention had 16 times more chances of increasing the depression levels compared to participants in the experimental group.
CONCLUSION


The use of biofeedback reduces depression, thus, representing a complementary alternative for the treatment of moderate and severe depression, and dysthymia.",2021,"The group that did not receive Biofeedback intervention had 16 times more chances of increasing the depression levels compared to participants in the experimental group.
",[],"['biofeedback intervention', 'Biofeedback intervention']","['depression levels', 'chances of increasing the depression levels']",[],"[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",36.0,0.0328683,"The group that did not receive Biofeedback intervention had 16 times more chances of increasing the depression levels compared to participants in the experimental group.
","[{'ForeName': 'Willams Henrique da Costa', 'Initials': 'WHDC', 'LastName': 'Maynart', 'Affiliation': 'School of Nursing. Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Maria Cicera Dos Santos de', 'Initials': 'MCDS', 'LastName': 'Albuquerque', 'Affiliation': 'School of Nursing. Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Regina Célia Sales', 'Initials': 'RCS', 'LastName': 'Santos', 'Affiliation': 'School of Nursing. Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Patrícia de Albuquerque', 'Initials': 'PA', 'LastName': 'Sarmento', 'Affiliation': 'School of Nursing. Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Jadelson Júnior da', 'Initials': 'JJD', 'LastName': 'Silva', 'Affiliation': 'School of Nursing. Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Christine de Sousa Gomes', 'Initials': 'CSG', 'LastName': 'Costa', 'Affiliation': 'School of Nursing. Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Jessica Diodino da Silva', 'Initials': 'JDDS', 'LastName': 'Santos', 'Affiliation': 'School of Nursing. Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Crislane de Oliveira', 'Initials': 'CO', 'LastName': 'Pontes', 'Affiliation': 'School of Nursing. Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Marcela Cristina Dos Santos', 'Initials': 'MCDS', 'LastName': 'Barros', 'Affiliation': 'School of Nursing. Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Flaviane Maria Pereira', 'Initials': 'FMP', 'LastName': 'Belo', 'Affiliation': 'School of Nursing. Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Christefany Régia Braz', 'Initials': 'CRB', 'LastName': 'Costa', 'Affiliation': 'Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Cyro Rego', 'Initials': 'CR', 'LastName': 'Cabral Júnior', 'Affiliation': 'School of Nutrition. Federal University of Alagoas, Maceió, Alagoas, Brazil.'}]",Acta neuropsychiatrica,['10.1017/neu.2020.46']
426,33431052,High-dose saccharin supplementation does not induce gut microbiota changes or glucose intolerance in healthy humans and mice.,"BACKGROUND


Non-caloric artificial sweeteners (NCAS) are widely used as a substitute for dietary sugars to control body weight or glycemia. Paradoxically, some interventional studies in humans and rodents have shown unfavorable changes in glucose homeostasis in response to NCAS consumption. The causative mechanisms are largely unknown, but adverse changes in gut microbiota have been proposed to mediate these effects. These findings have raised concerns about NCAS safety and called into question their broad use, but further physiological and dietary considerations must be first addressed before these results are generalized. We also reasoned that, since NCAS are bona fide ligands for sweet taste receptors (STRs) expressed in the intestine, some metabolic effects associated with NCAS use could be attributed to a common mechanism involving the host.
RESULTS


We conducted a double-blind, placebo-controlled, parallel arm study exploring the effects of pure saccharin compound on gut microbiota and glucose tolerance in healthy men and women. Participants were randomized to placebo, saccharin, lactisole (STR inhibitor), or saccharin with lactisole administered in capsules twice daily to achieve the maximum acceptable daily intake for 2 weeks. In parallel, we performed a 10-week study administering pure saccharin at a high dose in the drinking water of chow-fed mice with genetic ablation of STRs (T1R2-KO) and wild-type (WT) littermate controls. In humans and mice, none of the interventions affected glucose or hormonal responses to an oral glucose tolerance test (OGTT) or glucose absorption in mice. Similarly, pure saccharin supplementation did not alter microbial diversity or composition at any taxonomic level in humans and mice alike. No treatment effects were also noted in readouts of microbial activity such as fecal metabolites or short-chain fatty acids (SCFA). However, compared to WT, T1R2-KO mice were protected from age-dependent increases in fecal SCFA and the development of glucose intolerance.
CONCLUSIONS


Short-term saccharin consumption at maximum acceptable levels is not sufficient to alter gut microbiota or induce glucose intolerance in apparently healthy humans and mice.
TRIAL REGISTRATION


Trial registration number NCT03032640 , registered on January 26, 2017. Video abstract.",2021,"Similarly, pure saccharin supplementation did not alter microbial diversity or composition at any taxonomic level in humans and mice alike.","['healthy humans and mice', 'registered on January 26, 2017', 'apparently healthy humans and mice', 'healthy men and women']","['placebo, saccharin, lactisole (STR inhibitor), or saccharin with lactisole', 'placebo', 'genetic ablation of STRs (T1R2-KO) and wild-type (WT) littermate controls', 'saccharin supplementation', 'pure saccharin supplementation', 'pure saccharin compound', 'Non-caloric artificial sweeteners (NCAS', 'pure saccharin']","['gut microbiota changes or glucose intolerance', 'readouts of microbial activity such as fecal metabolites or short-chain fatty acids (SCFA', 'gut microbiota and glucose tolerance', 'fecal SCFA and the development of glucose intolerance', 'microbial diversity or composition at any taxonomic level', 'glucose or hormonal responses to an oral glucose tolerance test (OGTT) or glucose absorption']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036023', 'cui_str': 'Saccharin'}, {'cui': 'C1564960', 'cui_str': 'lactisole'}, {'cui': 'C1519302', 'cui_str': 'Short Tandem Repeats'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0003920', 'cui_str': 'Artificial sweetener'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",,0.0706765,"Similarly, pure saccharin supplementation did not alter microbial diversity or composition at any taxonomic level in humans and mice alike.","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Serrano', 'Affiliation': 'Department of Biological Chemistry & Pharmacology, College of Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Kathleen R', 'Initials': 'KR', 'LastName': 'Smith', 'Affiliation': 'Department of Biological Chemistry & Pharmacology, College of Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Audra L', 'Initials': 'AL', 'LastName': 'Crouch', 'Affiliation': 'Department of Microbiology, College of Arts & Sciences, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Sanford Burnham Prebys Medical Discovery Institute, La Jolla, CA, USA.'}, {'ForeName': 'Fanchao', 'Initials': 'F', 'LastName': 'Yi', 'Affiliation': 'Translational Research Institute for Metabolism and Diabetes, Advent-Health, Orlando, FL, USA.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Vargova', 'Affiliation': 'Translational Research Institute for Metabolism and Diabetes, Advent-Health, Orlando, FL, USA.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'LaMoia', 'Affiliation': 'Department of Biological Chemistry & Pharmacology, College of Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Lydia M', 'Initials': 'LM', 'LastName': 'Dupont', 'Affiliation': 'Department of Biological Chemistry & Pharmacology, College of Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Vanida', 'Initials': 'V', 'LastName': 'Serna', 'Affiliation': 'Department of Biological Chemistry & Pharmacology, College of Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Fenfen', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'Department of Food Science and Technology, College of Food, Agricultural & Environmental Sciences, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Laisa', 'Initials': 'L', 'LastName': 'Gomes-Dias', 'Affiliation': 'Department of Horticulture and Crop Science, College of Food, Agricultural & Environmental Sciences, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Blakeslee', 'Affiliation': 'Department of Horticulture and Crop Science, College of Food, Agricultural & Environmental Sciences, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Hatzakis', 'Affiliation': 'Department of Food Science and Technology, College of Food, Agricultural & Environmental Sciences, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Peterson', 'Affiliation': 'Sanford Burnham Prebys Medical Discovery Institute, La Jolla, CA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Department of Microbiology, College of Arts & Sciences, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'Translational Research Institute for Metabolism and Diabetes, Advent-Health, Orlando, FL, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Kyriazis', 'Affiliation': 'Department of Biological Chemistry & Pharmacology, College of Medicine, The Ohio State University, Columbus, OH, USA. Georgios.Kyriazis@osumc.edu.'}]",Microbiome,['10.1186/s40168-020-00976-w']
427,33446083,Tenecteplase in wake-up ischemic stroke trial: Protocol for a randomized-controlled trial.,"BACKGROUND


Patients with wake-up ischemic stroke who have evidence of salvageable tissue on advanced imaging can benefit from intravenous thrombolysis. It is not known whether patients who do not fulfil such imaging criteria might benefit from treatment, but studies indicate that treatment based on non-contrast CT criteria may be safe. Tenecteplase has shown promising results in patients with acute ischemic stroke. The aim of the Tenecteplase in Wake-up Ischemic Stroke Trial (TWIST) is to compare the effect of thrombolytic treatment with tenecteplase and standard care versus standard care alone in patients with wake-up ischemic stroke selected by non-contrast CT.
METHODS/DESIGN


TWIST is an international, investigator-initiated, multi-centre, prospective, randomized-controlled, open-label, blinded end-point trial of tenecteplase ( n  = 300) versus standard care ( n  = 300) in patients who wake up with an acute ischemic stroke and can be treated within 4.5 h upon awakening. Seventy-seven centres in 10 countries (Denmark, Estonia, Finland, Latvia, Lithuania, New Zealand, Norway, Sweden, Switzerland, and the United Kingdom) participate. The primary outcome is the modified Rankin Scale on the ordinal scale (0-6) at three months.
DISCUSSION


TWIST aims to determine the effect and safety of thrombolytic treatment with tenecteplase in patients with wake-up ischemic stroke selected by non-contrast CT.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03181360. EudraCT Number 2014-000096-80.",2021,"BACKGROUND


Patients with wake-up ischemic stroke who have evidence of salvageable tissue on advanced imaging can benefit from intravenous thrombolysis.","['Patients with wake-up ischemic stroke', 'Seventy-seven centres in 10 countries (Denmark, Estonia, Finland, Latvia, Lithuania, New Zealand, Norway, Sweden, Switzerland, and the United Kingdom) participate', ' n \u2009=\u2009300) in patients who wake up with an acute ischemic stroke and can be treated within 4.5\u2009h upon awakening', 'patients with wake-up ischemic stroke selected by non-contrast CT', 'patients with acute ischemic stroke']","['thrombolytic treatment with tenecteplase and standard care versus standard care alone', 'tenecteplase ( n \u2009=\u2009300) versus standard care', 'EudraCT']",['modified Rankin Scale on the ordinal scale'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0014908', 'cui_str': 'Estonia'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0023879', 'cui_str': 'Lithuania'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0016018', 'cui_str': 'Thrombolytic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.159412,"BACKGROUND


Patients with wake-up ischemic stroke who have evidence of salvageable tissue on advanced imaging can benefit from intravenous thrombolysis.","[{'ForeName': 'Melinda B', 'Initials': 'MB', 'LastName': 'Roaldsen', 'Affiliation': 'Department of Neurology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Haakon', 'Initials': 'H', 'LastName': 'Lindekleiv', 'Affiliation': 'Quality and Development Centre, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Agnethe', 'Initials': 'A', 'LastName': 'Eltoft', 'Affiliation': 'Department of Neurology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mirza', 'Initials': 'M', 'LastName': 'Jusufovic', 'Affiliation': 'Department of Neurology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mary-Helen', 'Initials': 'MH', 'LastName': 'Søyland', 'Affiliation': 'Department of Neurology, Hospital of Southern Norway, Kristiansand, Norway.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Petersson', 'Affiliation': 'Department of Neurology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Indredavik', 'Affiliation': 'Department of Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Arnstein', 'Initials': 'A', 'LastName': 'Tveiten', 'Affiliation': 'Department of Neurology, Hospital of Southern Norway, Kristiansand, Norway.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Putaala', 'Affiliation': 'Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Department of Neurology, Bispebjerg Hospital and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Kõrv', 'Affiliation': 'Department of Neurology and Neurosurgery, University of Tartu and Tartu University Hospital, Tartu, Estonia.'}, {'ForeName': 'Dalius', 'Initials': 'D', 'LastName': 'Jatužis', 'Affiliation': 'Department of Neurology and Neurosurgery, Center for Neurology, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Stefan T', 'Initials': 'ST', 'LastName': 'Engelter', 'Affiliation': 'Department of Neurology, University Hospital of Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Gian', 'Initials': 'G', 'LastName': 'Marco De Marchis', 'Affiliation': 'Department of Neurology, University Hospital of Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wilsgaard', 'Affiliation': 'Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Werring', 'Affiliation': 'Stroke Research Centre, UCL Queen Square Institute of Neurology, London, UK.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Ellisiv B', 'Initials': 'EB', 'LastName': 'Mathiesen', 'Affiliation': 'Department of Neurology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Berge', 'Affiliation': 'Department of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, Norway.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020984073']
428,33420602,Efficacy of Valerian Extract on Sleep Quality after Coronary Artery bypass Graft Surgery: A Triple-Blind Randomized Controlled Trial.,"OBJECTIVE


To assess the effect of valerian root extract on the sleep quality of patients after coronary artery bypass graft (CABG) surgery.
METHODS


The patients who participated in this triple-blind clinical trial were selected by permuted block randomization. The participants were assigned to the valerian (n=36) and placebo (n=36) groups. The valerian group received 530 mg of valerian capsules for 30 nights after CABG surgery, and the placebo group received 530 mg of the placebo capsules containing wheat flour. The Pittsburgh Sleep Quality Index (PSQI), the prothrombin time (PT) and partial thromboplastin time (PTT) were assessed on four occasions, including the baseline, the 3rd, 14th and 30th days following intervention.
RESULTS


The odds ratio of worsened sleep quality significantly varied over time (the interaction of time and group) in the valerian group compared to the placebo group in various dimensions including total sleep quality (P=0.001), sleep latency (P<0.01), sleep duration (P=0.020), sleep efficiency (P=0.001) and daytime dysfunction (P=0.025). No significant difference was observed in the alterations of the odds ratio of PT in the two groups over time. (P=0.371).
CONCLUSION


The consumption of oral valerian root extract over 30 nights could significantly improve the patients' sleep quality safely after CABG surgery.",2021,No significant difference was observed in the alterations of the odds ratio of PT in the two groups over time.,"['after Coronary Artery bypass Graft Surgery', 'patients after coronary artery bypass graft (CABG) surgery']","['placebo capsules containing wheat flour', 'placebo', 'Valerian Extract', 'valerian root extract', 'valerian capsules']","['sleep quality', 'daytime dysfunction', 'alterations of the odds ratio of PT', 'sleep efficiency', 'odds ratio of worsened sleep quality', 'total sleep quality', 'Pittsburgh Sleep Quality Index (PSQI), the prothrombin time (PT) and partial thromboplastin time (PTT', ""patients' sleep quality safely"", 'sleep latency (P<0.01), sleep duration', 'Sleep Quality']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour'}, {'cui': 'C0795674', 'cui_str': 'valerian root extract'}, {'cui': 'C0042281', 'cui_str': 'Valeriana'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}]",,0.204862,No significant difference was observed in the alterations of the odds ratio of PT in the two groups over time.,"[{'ForeName': 'Halimeh Khaton', 'Initials': 'HK', 'LastName': 'Zare Elmi', 'Affiliation': 'Student Research Committee, Lorestan University of Medical Sciences, Khorramabad, 6814993165, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Gholami', 'Affiliation': 'School of Nursing and Midwifery, Lorestan University of Medical Sciences, Khorramabad, 6814993165, Iran. mohammad13565@yahoo.com.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Saki', 'Affiliation': 'Social Determinants of Health Research Center, Lorestan University of Medical Sciences, Khorramabad, 6814993165, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Ebrahimzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health and Nutrition, Lorestan University of Medical Sciences, Khorramabad, 6814993165, Iran.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-2727-1']
429,33428439,The Effect of Flat Flexible Versus Stable Supportive Shoes on Knee Osteoarthritis Symptoms : A Randomized Trial.,"BACKGROUND


Experts recommend that persons with knee osteoarthritis wear stable supportive shoes; however, evidence suggests that flat flexible shoes may be more beneficial.
OBJECTIVE


To compare flat flexible with stable supportive shoes for knee osteoarthritis symptoms.
DESIGN


Participant- and assessor-blinded randomized trial. (Prospectively registered with the Australian New Zealand Clinical Trials Registry [ACTRN12617001098325]).
SETTING


Community.
PARTICIPANTS


164 patients with moderate to severe symptomatic radiographic medial knee osteoarthritis.
INTERVENTION


Flat flexible ( n  = 82) or stable supportive shoes ( n  = 82), worn for at least 6 hours a day for 6 months.
MEASUREMENTS


Primary outcomes were changes in walking pain (measured by an 11-point numerical rating scale) and physical function (as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale of 0 to 68 points) at 6 months. Secondary outcomes included additional pain and function measures, physical activity, and quality of life. Other measures included adverse events.
RESULTS


Of 164 participants recruited, 161 (98%) completed 6-month primary outcomes. No evidence was found that flat flexible shoes were superior to stable supportive shoes in primary outcomes. Evidence did show a between-group difference in change in pain favoring stable supportive shoes (mean difference, 1.1 units [95% CI, 0.5 to 1.8 units];  P  = 0.001) but not function (mean difference, 2.3 units [CI, -0.9 to 5.5 units];  P  = 0.167). Improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes (mean difference, -5.3 units [CI, -10.0 to -0.5 units] and 0.7 units [CI, 0.0 to 1.4 units], respectively). Flat flexible shoes were not superior to stable supportive shoes for any secondary outcome. Fewer participants reported adverse events with stable supportive shoes ( n  = 12 [15%]) compared with flat flexible shoes ( n  = 26 [32%]) (risk difference, -0.17 [CI, -0.30 to -0.05]).
LIMITATION


No ""usual shoes"" control group and a select patient subgroup, which may limit generalizability.
CONCLUSION


Flat flexible shoes were not superior to stable supportive shoes. Contrary to our hypothesis, stable supportive shoes improved knee pain on walking more than flat flexible shoes.
PRIMARY FUNDING SOURCE


National Health and Medical Research Council.",2021,"Improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes (mean difference, -5.3 units [CI, -10.0 to -0.5 units] and 0.7 units [CI, 0.0 to 1.4 units], respectively).","['Of 164 participants recruited, 161 (98%) completed 6-month primary outcomes', 'Community', 'persons with knee osteoarthritis wear stable supportive shoes', '164 patients with moderate to severe symptomatic radiographic medial knee osteoarthritis']","['Flat flexible ( n \u2009= 82) or stable supportive shoes', 'Flat Flexible Versus Stable Supportive Shoes', 'flat flexible with stable supportive shoes']","['change in pain favoring stable supportive shoes', 'knee-related quality of life and ipsilateral hip pain', 'adverse events', 'Knee Osteoarthritis Symptoms ', 'changes in walking pain (measured by an 11-point numerical rating scale) and physical function (as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale', 'knee pain', 'additional pain and function measures, physical activity, and quality of life']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205098', 'cui_str': 'Medial'}]","[{'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",164.0,0.183294,"Improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes (mean difference, -5.3 units [CI, -10.0 to -0.5 units] and 0.7 units [CI, 0.0 to 1.4 units], respectively).","[{'ForeName': 'Kade L', 'Initials': 'KL', 'LastName': 'Paterson', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia (K.L.P., K.L.B., P.K.C., B.R.M., T.V.W., R.S.H.).'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia (K.L.P., K.L.B., P.K.C., B.R.M., T.V.W., R.S.H.).'}, {'ForeName': 'Penny K', 'Initials': 'PK', 'LastName': 'Campbell', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia (K.L.P., K.L.B., P.K.C., B.R.M., T.V.W., R.S.H.).'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Metcalf', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia (K.L.P., K.L.B., P.K.C., B.R.M., T.V.W., R.S.H.).'}, {'ForeName': 'Tim V', 'Initials': 'TV', 'LastName': 'Wrigley', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia (K.L.P., K.L.B., P.K.C., B.R.M., T.V.W., R.S.H.).'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia (J.K.).'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia (K.L.P., K.L.B., P.K.C., B.R.M., T.V.W., R.S.H.).'}]",Annals of internal medicine,['10.7326/M20-6321']
430,33443117,The STARS Phase 2 Study: A Randomized Controlled Trial of Gaboxadol in Angelman Syndrome.,"OBJECTIVE


To evaluate safety and tolerability and exploratory efficacy end points for gaboxadol (OV101) compared with placebo in individuals with Angelman syndrome (AS).
METHODS


Gaboxadol is a highly selective orthosteric agonist that activates δ-subunit-containing extrasynaptic γ-aminobutyric acid type A (GABA A ) receptors. In a multicenter, double-blind, placebo-controlled, parallel-group trial, adolescent and adult individuals with a molecular diagnosis of AS were randomized (1:1:1) to 1 of 3 dosing regimens for a duration of 12 weeks: placebo morning dose and gaboxadol 15 mg evening dose (qd), gaboxadol 10 mg morning dose and 15 mg evening dose (bid), or placebo morning and evening dose. Safety and tolerability were monitored throughout the study. Prespecified exploratory efficacy end points included adapted Clinical Global Impression-Severity and Clinical Global Impression-Improvement (CGI-I) scales, which documented the clinical severity at baseline and change after treatment, respectively.
RESULTS


Eighty-eight individuals were randomized. Of 87 individuals (aged 13-45 years) who received at least 1 dose of study drug, 78 (90%) completed the study. Most adverse events (AEs) were mild to moderate, and no life-threatening AEs were reported. Efficacy of gaboxadol, as measured by CGI-I improvement in an exploratory analysis, was observed in gaboxadol qd vs placebo ( p  = 0.0006).
CONCLUSION


After 12 weeks of treatment, gaboxadol was found to be generally well-tolerated with a favorable safety profile. The efficacy as measured by the AS-adapted CGI-I scale warrants further studies.
CLINICALTRIALSGOV IDENTIFIER


NCT02996305.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that, for individuals with AS, gaboxadol is generally safe and well-tolerated.",2021,"Efficacy of gaboxadol, as measured by CGI-I improvement in an exploratory analysis, was observed in gaboxadol qd vs placebo ( p  = 0.0006).
","['Eighty-eight individuals', 'Angelman Syndrome', 'adolescent and adult individuals with a molecular diagnosis of AS', '87 individuals (aged 13-45 years) who received at least 1 dose of study drug, 78 (90%) completed the study', 'individuals with Angelman syndrome (AS']","['gaboxadol', 'placebo', 'gaboxadol qd vs placebo', 'placebo morning dose and gaboxadol 15 mg evening dose (qd); gaboxadol 10 mg morning dose and 15 mg evening dose (bid); or placebo', 'Gaboxadol', 'gaboxadol (OV101']","['safety and tolerability and exploratory efficacy endpoints', 'Safety and tolerability', 'Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI']","[{'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0162635', 'cui_str': 'Angelman syndrome'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0047845', 'cui_str': 'gaboxadol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0587117', 'cui_str': 'Evening'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",88.0,0.392542,"Efficacy of gaboxadol, as measured by CGI-I improvement in an exploratory analysis, was observed in gaboxadol qd vs placebo ( p  = 0.0006).
","[{'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Bird', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Ochoa-Lubinoff', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Wen-Hann', 'Initials': 'WH', 'LastName': 'Tan', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Gali', 'Initials': 'G', 'LastName': 'Heimer', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Raun D', 'Initials': 'RD', 'LastName': 'Melmed', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Rakhit', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Visootsak', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'During', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Holcroft', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Rebecca D', 'Initials': 'RD', 'LastName': 'Burdine', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston. alexander.kolevzon@mssm.edu.""}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Thibert', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}]",Neurology,['10.1212/WNL.0000000000011409']
431,33822372,The intention was good: How promoting strategy use does not improve multimedia learning for secondary students.,"BACKGROUND


It is well established that successful learning with multimedia is challenging, especially for younger learners.
AIMS


It was investigated whether students would profit from instructional support regarding the use of multimedia learning strategies.
SAMPLE


Participants were high school students in 8 th  , 9 th  , and 10 th  grade (N = 168).
METHODS


Participants were assigned to a no-support control group or one of four experimental groups. In the experimental groups, students received either only a multimedia strategy training before learning (training group) or the training was enriched by prompts (prompts before or during learning) or if-then plans (implementation intentions). In the training, multimedia learning strategies were introduced (e.g., linking information from text and picture). The prompts and implementation intentions were aimed at enhancing the application of the multimedia strategies conveyed through the training. Students learned about the process of mitosis by studying multimedia instructions and were tested regarding the acquired knowledge. It was expected that solely training students to use adequate multimedia learning strategies would not promote learning compared with the control group, rather, that additional support like prompts or implementation intentions would be necessary to enhance learning.
RESULTS


Although in the experimental groups, multimedia learning strategies were used more frequently especially in the beginning of the instructional unit, there were no effects on learning outcome.
CONCLUSIONS


Promoting multimedia strategy use did not improve learning. The quality of the different instructional support measures and their suitability for the target groups are discussed as possible explanations for these findings.",2021,"It was expected that solely training students to use adequate multimedia learning strategies would not promote learning compared with the control group, rather, that additional support like prompts or implementation intentions would be necessary to enhance learning.
","['Participants', 'Participants were high school students in 8 th  , 9 th  , and 10 th  grade (N\xa0=\xa0168']",['multimedia strategy training before learning (training group) or the training was enriched by prompts (prompts before or during learning) or if-then plans (implementation intentions'],['learning'],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0589105', 'cui_str': 'Strategy training'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.0162953,"It was expected that solely training students to use adequate multimedia learning strategies would not promote learning compared with the control group, rather, that additional support like prompts or implementation intentions would be necessary to enhance learning.
","[{'ForeName': 'Emely', 'Initials': 'E', 'LastName': 'Hoch', 'Affiliation': 'Leibniz-Institut für Wissensmedien, Tübingen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Scheiter', 'Affiliation': 'Leibniz-Institut für Wissensmedien, Tübingen, Germany.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Stalbovs', 'Affiliation': 'Leibniz-Institut für Wissensmedien, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gerjets', 'Affiliation': 'Leibniz-Institut für Wissensmedien, Tübingen, Germany.'}]",The British journal of educational psychology,['10.1111/bjep.12417']
432,33469187,Continuous chest compressions with asynchronous ventilations increase carotid blood flow in the perinatal asphyxiated lamb model.,"BACKGROUND


The neonatal resuscitation program (NRP) recommends interrupted chest compressions (CCs) with ventilation in the severely bradycardic neonate. The conventional 3:1 compression-to-ventilation (C:V) resuscitation provides 90 CCs/min, significantly lower than the intrinsic newborn heart rate (120-160 beats/min). Continuous CC with asynchronous ventilation (CCCaV) may improve the success of return of spontaneous circulation (ROSC).
METHODS


Twenty-two near-term fetal lambs were randomized to interrupted 3:1 C:V (90 CCs + 30 breaths/min) or CCCaV (120 CCs + 30 breaths/min). Asphyxiation was induced by cord occlusion. After 5 min of asystole, resuscitation began following NRP guidelines. The first dose of epinephrine was given at 6 min. Invasive arterial blood pressure and left carotid blood flow were continuously measured. Serial arterial blood gases were collected.
RESULTS


Baseline characteristics between groups were similar. Rate of and time to ROSC was similar between groups. CCCaV was associated with a higher PaO 2  (partial oxygen tension) (22 ± 5.3 vs. 15 ± 3.5 mmHg, p < 0.01), greater left carotid blood flow (7.5 ± 3.1 vs. 4.3 ± 2.6 mL/kg/min, p < 0.01) and oxygen delivery (0.40 ± 0.15 vs. 0.13 ± 0.07 mL O 2 /kg/min, p < 0.01) compared to 3:1 C:V.
CONCLUSIONS


In a perinatal asphyxiated cardiac arrest lamb model, CCCaV showed greater carotid blood flow and cerebral oxygen delivery compared to 3:1 C:V resuscitation.
IMPACT


In a perinatal asphyxiated cardiac arrest lamb model, CCCaV improved carotid blood flow and oxygen delivery to the brain compared to the conventional 3:1 C:V resuscitation. Pre-clinical studies assessing neurodevelopmental outcomes and tissue injury comparing continuous uninterrupted chest compressions to the current recommended 3:1 C:V during newborn resuscitation are warranted prior to clinical trials.",2021,"CCCaV was associated with a higher PaO 2  (partial oxygen tension) (22 ± 5.3 vs. 15 ± 3.5 mmHg, p < 0.01), greater left carotid blood flow (7.5 ± 3.1 vs. 4.3 ± 2.6 mL/kg/min, p < 0.01) and oxygen delivery (0.40 ± 0.15 vs. 0.13 ± 0.07 mL O 2 /kg/min, p < 0.01) compared to 3:1 C:V.
CONCLUSIONS


",['Twenty-two near-term fetal lambs'],"['conventional 3:1 compression-to-ventilation (C:V) resuscitation', 'CCCaV', 'epinephrine', 'Continuous CC with asynchronous ventilation (CCCaV', 'neonatal resuscitation program (NRP) recommends interrupted chest compressions (CCs) with ventilation', 'continuous uninterrupted chest compressions']","['Invasive arterial blood pressure and left carotid blood flow', 'greater left carotid blood flow', 'Rate of and time to ROSC', 'carotid blood flow', 'oxygen delivery', 'carotid blood flow and oxygen delivery', 'success of return of spontaneous circulation (ROSC', 'carotid blood flow and cerebral oxygen delivery', 'Serial arterial blood gases']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0406810', 'cui_str': 'Carney complex'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}]",,0.0224906,"CCCaV was associated with a higher PaO 2  (partial oxygen tension) (22 ± 5.3 vs. 15 ± 3.5 mmHg, p < 0.01), greater left carotid blood flow (7.5 ± 3.1 vs. 4.3 ± 2.6 mL/kg/min, p < 0.01) and oxygen delivery (0.40 ± 0.15 vs. 0.13 ± 0.07 mL O 2 /kg/min, p < 0.01) compared to 3:1 C:V.
CONCLUSIONS


","[{'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Vali', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, CA, USA. pvali@ucdavis.edu.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lesneski', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Hardie', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Alhassen', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Houssam', 'Initials': 'H', 'LastName': 'Joudi', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Sankaran', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, CA, USA.'}]",Pediatric research,['10.1038/s41390-020-01306-4']
433,33478620,Comparing rubbing and scrubbing surgical hand antisepsis with propan-1-ol 60% in accordance with European regulation UNE-EN 12791:2016+A1:2018.,"A crossover trial was conducted to compare hand rub and hand scrub-brush methods for reducing bacterial loads when using propan-1-ol-60% according to European regulations. Both methods significantly reduced the bacterial load immediately after antisepsis, but only the hand rub method achieved significant bacterial load reduction 3 hours after the procedure.",2021,"Both methods significantly reduced the bacterial load immediately after antisepsis, but only the hand rub method achieved significant bacterial load reduction 3 hours after the procedure.",[],['hand rub and hand scrub-brush methods'],['bacterial loads'],[],"[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C2936404', 'cui_str': 'Bacterial Load'}]",,0.0214978,"Both methods significantly reduced the bacterial load immediately after antisepsis, but only the hand rub method achieved significant bacterial load reduction 3 hours after the procedure.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Martin-Villa', 'Affiliation': 'Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Becerro-de-Bengoa-Vallejo', 'Affiliation': 'Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Alou', 'Affiliation': 'Área de Microbiología, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'González', 'Affiliation': 'Área de Microbiología, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Losa-Iglesias', 'Affiliation': 'Facultad de Ciencias de la Salud, Universidad Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'Gómez-Lus', 'Affiliation': 'Área de Microbiología, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sevillano', 'Affiliation': 'Área de Microbiología, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.'}]",Infection control and hospital epidemiology,['10.1017/ice.2020.1388']
434,33496439,A Comparison Between the Effect of Combined Chain Exercises Plus Kinesio Taping With Combined Chain Exercises Alone in Knee Osteoarthritis: A Randomized Clinical Trial.,"OBJECTIVE


This study aimed to examine the effect of Kinesio taping as an adjunct to combined chain exercises compared with combined chain exercises alone in the management of individuals with knee osteoarthritis.
METHODS


A total of 60 (27 male, 33 female) individuals (age range = 50-71 yrs and mean age = 54.26 ± 8.83 yrs) diagnosed as having mild to moderate knee osteoarthritis (based on the Kellgren and Lawrence grade I-III classification) were randomly allocated into two groups with 30 participants each in the Kinesio taping + combined chain exercises and combined chain exercises groups. Participants in the Kinesio taping + combined chain exercises group received Kinesio taping plus combined chain exercises and those in the combined chain exercises group received only combined chain exercises. Each participant was assessed for pain, range of motion, functional mobility, and quality of life at baseline and after 8 wks of intervention. A mixed-design multivariate analysis of variance was used to analyze the treatment effect.
RESULTS


No significant differences were observed in the baseline characteristics of participants in both groups. The result indicated that there was a significant time effect for all outcomes, with a significant interaction between time and intervention (P < 0.001). The Bonferroni post hoc analyses of time and intervention effects indicated that the Kinesio taping + combined chain exercises group improved significantly better than the combined chain exercises group in all outcomes, pain (mean = 2.01 [0.64] vs. 3.94 [1.12], F[df] = 5.466[1,58], P = 0.011), flexion range of motion (mean = 121.15 [2.07] vs. 104.28 [3.24], F[df] = 26.722[1,58], P < 0.001), functional mobility (mean = 19.47 [1.95] vs. 31.01 [2.39], F[df] = 29.436[1,58], P < 0.001), and quality of life (mean = 68.76 [3.19] vs. 45.62 [2.87], F[df] = 71.984[1,58], P < 0.001), after 8 wks of intervention.
CONCLUSIONS


The findings of this study concluded that Kinesio taping + combined chain exercises and combined chain exercises were both effective but Kinesio taping plus combined chain exercises was more effective in the management of individuals with knee osteoarthritis.
TRIAL REGISTRATION


Pan African Clinical Trial Registry: PACTR201810603949411.",2021,No significant differences were observed in the baseline characteristics of participants in both groups.,"['A total of 60 (27 males; 33 females) individuals (age range of 50-71 years and mean age of 54.26±8.83) diagnosed as having mild to moderate knee OA (based on the Kellgren and Lawrence grade', 'individuals with knee osteoarthritis (OA', 'Knee Osteoarthritis']","['KT plus CCEs', 'Combined Chain Exercises plus Kinesio Taping With Combined Chain Exercises', 'CCEs', 'Kinesio taping (KT', 'KT+CCEs and CCEs', 'Kinesio taping plus combined chain exercises and those in the CCEs group received only combined chain exercises', 'CCEs alone', 'combined chain exercises (CCEs', 'KT+CCEs']","['pain, range of motion, functional mobility, and quality of life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0500123,No significant differences were observed in the baseline characteristics of participants in both groups.,"[{'ForeName': 'Musa Sani', 'Initials': 'MS', 'LastName': 'Danazumi', 'Affiliation': 'From the Department of Physiotherapy, Federal Medical Centre, Nguru, Yobe State, Nigeria (MSD); Department of Physiotherapy, College of Health Sciences, Faculty of Allied Health Sciences, Bayero University, Kano, Nigeria (MSD, SUI, BB, BK); Medical Rehabilitation Therapists Board (Reg.), North-West Zonal Office, Kano, Nigeria (AMY); Department of Physiotherapy, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa (AMY); and School of Nursing and Midwifery, Edith Cowan University, Joondalup, Western Australia, Australia (GD).'}, {'ForeName': 'Shehu Usman', 'Initials': 'SU', 'LastName': 'Ibrahim', 'Affiliation': ''}, {'ForeName': 'Abdulsalam Mohammed', 'Initials': 'AM', 'LastName': 'Yakasai', 'Affiliation': ''}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Dermody', 'Affiliation': ''}, {'ForeName': 'Bashir', 'Initials': 'B', 'LastName': 'Bello', 'Affiliation': ''}, {'ForeName': 'Bashir', 'Initials': 'B', 'LastName': 'Kaka', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001705']
435,33426790,The youth online training and employment system: Study protocol for a randomized controlled trial of an online vocational intervention for young people with mental ill health.,"AIM


People diagnosed with mental disorders experience higher rates of unemployment than those without. Career adaptability, defined as the ability to respond flexibly and make informed career decisions in work and throughout career transitions, is becoming increasingly important as the nature of work changes rapidly. Early vocational intervention may ameliorate poor education and employment outcomes experienced by young people with mental ill-health and promote transferable skills and adaptability. Online-based career support allows for ongoing access throughout different career stages. The current study combines mental health-informed digital career and peer motivation, to create a Youth Online Training and Employment System (YOTES) that supports young people with mental ill-health obtain and remain in education or employment.
METHODS


This study is an unblinded randomized controlled trial for young people with mental ill-health, aged 16-25, who are seeking vocational support. Participants will be randomized to receive either YOTES, a moderated, online intervention with vocational, social, and peer motivation, or a control intervention, the headspace Digital Work and Study Service. Both groups will have access to in-person career support if seeking employment. The primary outcome will be career adaptability compared between the YOTES and control groups at 6-months post baseline. Secondary outcomes include number of hours worked in the past 7 days, hope, career confidence, psychological distress and health economic outcomes at 6- and 12-months post baseline.
CONCLUSION


Results will demonstrate whether an online career intervention moderated by career practitioners with peer motivation can result in improved career adaptability in young people with mental ill-health.",2021,Early vocational intervention may ameliorate poor education and employment outcomes experienced by young people with mental ill-health and promote transferable skills and adaptability.,"['young people with mental ill-health', 'young people with mental ill-health and promote transferable skills and adaptability', 'young people with mental ill-health, aged 16-25, who are seeking vocational support', 'young people with mental ill health', 'young people with mental ill-health obtain and remain in education or employment', 'People diagnosed with mental disorders']","['Online-based career support', 'online vocational intervention', 'YOTES, a moderated, online intervention with vocational, social, and peer motivation, or a control intervention, the headspace Digital Work and Study Service', 'mental health-informed digital career and peer motivation, to create a Youth Online Training and Employment System (YOTES', 'Early vocational intervention']","['number of hours worked in the past 7\u2009days, hope, career confidence, psychological distress and health economic outcomes', 'career adaptability']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.135835,Early vocational intervention may ameliorate poor education and employment outcomes experienced by young people with mental ill-health and promote transferable skills and adaptability.,"[{'ForeName': 'Magenta B', 'Initials': 'MB', 'LastName': 'Simmons', 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Nicholas', 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Chinnery', 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}, {'ForeName': 'Shaunagh', 'Initials': 'S', 'LastName': ""O'Sullivan"", 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': ""D'Alfonso"", 'Affiliation': 'School of Computing and Information Systems, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bendall', 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cagliarini', 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hamilton', 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gleeson', 'Affiliation': 'Healthy Brain and Mind Research Centre and School of Behavioural and Health Sciences, Australian Catholic University, Victoria, Australia.'}, {'ForeName': 'Eóin', 'Initials': 'E', 'LastName': 'Killackey', 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}]",Early intervention in psychiatry,['10.1111/eip.13100']
436,33470633,Carbon Monoxide Diffusing Capacity Predicts Cardiac Readmission in Patients Undergoing Left Ventricular Assist Device Implantation in Japan.,"Carbon monoxide diffusion capacity (DLCO) is impaired in heart failure patients; however, its clinical impact has not been well investigated in the left ventricular assist device (LVAD) population. We explored the predictive value of preoperative DLCO in the survival and cardiac readmission rates after LVAD implantation. Seventy-six patients who received continuous-flow LVAD as bridge-to-transplant therapy from November 2007 to September 2018 and underwent pulmonary function test before LVAD implantation were included. The primary study endpoints were death and readmission for heart failure or arrhythmia (cardiac readmission). Patients were stratified into two groups according to the percent of predicted DLCO (%DLCO). Pulmonary vascular resistance (PVR) was equivocal between the groups preoperatively, whereas the low DLCO group (%DLCO < 80%) showed significantly high PVR postoperatively. The mortality rate was not different between the groups. The 2 year cardiac readmission rate was 33.5% in the low DLCO group and 8.7% in the high DLCO group (%DLCO ≥ 80%) (P = 0.028). The %DLCO was associated with cardiac readmission in univariate and multivariate analyses (hazard ratio: 4.32; 95% CI: 1.50-15.9; P = 0.005). Low %DLCO was associated with high PVR postoperatively and was a risk factor for cardiac readmission after LVAD implantation.",2021,Low %DLCO was associated with high PVR postoperatively and was a risk factor for cardiac readmission after LVAD implantation.,"['Patients Undergoing Left Ventricular Assist Device Implantation in Japan', 'Seventy-six patients who received continuous-flow LVAD as bridge-to-transplant therapy from November 2007 to September 2018 and underwent pulmonary function test before LVAD implantation were included', 'heart failure patients']","['LVAD implantation', 'Carbon monoxide diffusion capacity (DLCO', 'Carbon Monoxide Diffusing Capacity']","['Pulmonary vascular resistance (PVR', 'mortality rate', 'death and readmission for heart failure or arrhythmia (cardiac readmission', 'survival and cardiac readmission rates', 'cardiac readmission rate', 'cardiac readmission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0199525', 'cui_str': 'Carbon monoxide diffusing capacity measurement'}]","[{'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",76.0,0.0221881,Low %DLCO was associated with high PVR postoperatively and was a risk factor for cardiac readmission after LVAD implantation.,"[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Tsuji', 'Affiliation': 'From the Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Amiya', 'Affiliation': 'From the Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Chie', 'Initials': 'C', 'LastName': 'Bujo', 'Affiliation': 'From the Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Hara', 'Affiliation': 'From the Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Saito', 'Affiliation': 'From the Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Minatsuki', 'Affiliation': 'From the Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hisataka', 'Initials': 'H', 'LastName': 'Maki', 'Affiliation': 'From the Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Ishida', 'Affiliation': 'From the Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Hosoya', 'Affiliation': 'From the Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Hatano', 'Affiliation': 'From the Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Imai', 'Affiliation': 'Department of Organ Transplantation, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Nemoto', 'Affiliation': 'Department of Organ Transplantation, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yukie', 'Initials': 'Y', 'LastName': 'Kagami', 'Affiliation': 'Department of Organ Transplantation, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Miyoko', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Department of Organ Transplantation, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Mitsutoshi', 'Initials': 'M', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Shimada', 'Affiliation': 'Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Komuro', 'Affiliation': 'From the Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",ASAIO journal (American Society for Artificial Internal Organs : 1992),['10.1097/MAT.0000000000001363']
437,33495919,Nafamostat Mesylate is Not Effective in Preventing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.,"BACKGROUND


Endoscopic retrograde cholangiopancreatography (ERCP) is associated with complications such as post-ERCP pancreatitis (PEP). Protease inhibitors, including nafamostat mesylate (NM), have been evaluated for prophylaxis against PEP.
AIM


We describe the first multicenter randomized controlled trial assessing the prophylactic efficacy of NM against PEP.
METHODS


In this multicenter prospective study, we aimed to enroll 800 patients aged ≥ 20 years with a planned ERCP between December 2012 and March 2019. The primary outcome was the incidence and severity of PEP in patients who did not receive NM (non-NM) versus those who did (NM; 20 mg). Secondary outcomes included the incidence of PEP by NM initiation (pre- and post-ERCP), risk factors for PEP, and NM-related adverse events.
RESULTS


Only 441 of the planned 800 patients were enrolled (non-NM: n = 149; NM: n = 292 [pre-ERCP NM: n = 144; post-ERCP NM: n = 148]). Patient characteristics were balanced at baseline with no significant differences between groups. PEP occurred in 40/441 (9%) patients (non-NM: n = 15 [10%]; NM: n = 25 [9%]), including 17 (12%) and eight (8%) in the pre-ERCP and post-ERCP NM groups, respectively. In the NM group, the incidence of PEP was lower in the low-risk group than in the high-risk group. Pancreatic injection and double-guidewire technique were independent risk factors for PEP. NM-related adverse events of hyperkalemia occurred in two (0.7%) patients.
CONCLUSIONS


We found no evidence for the prophylactic effect of NM against PEP, regardless of the timing of administration; however, further studies are needed.",2021,"In the NM group, the incidence of PEP was lower in the low-risk group than in the high-risk group.","['800 patients aged ≥', '20\xa0years with a planned ERCP between December 2012 and March 2019', 'Only 441 of the planned 800 patients were enrolled (non-NM: n\u2009=\u2009149; NM: n\u2009=\u2009292 [pre-ERCP NM: n\u2009=\u2009144; post-ERCP NM: n\u2009=\u2009148']","['NM against PEP', 'Protease inhibitors, including nafamostat mesylate (NM', 'Endoscopic retrograde cholangiopancreatography (ERCP', 'Nafamostat Mesylate', 'Pancreatic injection and double-guidewire technique']","['incidence of PEP', 'NM-related adverse events of hyperkalemia', 'incidence of PEP by NM initiation (pre- and post-ERCP), risk factors for PEP, and NM-related adverse events', 'PEP', 'incidence and severity of PEP']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0207682', 'cui_str': 'nafamostat mesilate'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0207682', 'cui_str': 'nafamostat mesilate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0207682', 'cui_str': 'nafamostat mesilate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",800.0,0.0754555,"In the NM group, the incidence of PEP was lower in the low-risk group than in the high-risk group.","[{'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Okuwaki', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan. kokuwaki@kitasato-u.ac.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Imaizumi', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Kida', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Iwai', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Rikiya', 'Initials': 'R', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Masutani', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Tadehara', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Adachi', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kurosu', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Tamaki', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}, {'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Gastroenterology, Hiratsuka Kyosai Hospital, 9-11 Oiwake, Hiratsuka, Kanagawa, 254-8502, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ohno', 'Affiliation': 'Department of Gastroenterology, Isehara Kyodo Hospital, 345 Tanaka, Isehara, Kanagawa, 259-1187, Japan.'}, {'ForeName': 'Wasaburo', 'Initials': 'W', 'LastName': 'Koizumi', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06782-6']
438,33450365,Efficacy of lumbar immobilisation by rigid brace for chronic low back pain with Modic 1 changes (DICO): Protocol for a randomised study.,,2021,,['chronic low back pain with Modic 1 changes (DICO'],['lumbar immobilisation by rigid brace'],[],"[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0006086', 'cui_str': 'Brace'}]",[],,0.0673396,,"[{'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'Bonnin', 'Affiliation': 'Service de médecine physique et de réadaptation, CHU Clermont-Ferrand, Université Clermont Auvergne, INRAE, UNH, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lanhers', 'Affiliation': 'Centre de médecine physique et de réadaptation Notre Dame, 63400 Chamalières, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Coste', 'Affiliation': 'Service de médecine physique et de réadaptation, CHU Clermont-Ferrand, Université Clermont Auvergne, INRAE, UNH, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': 'Service de médecine physique et de réadaptation, CHU Clermont-Ferrand, Université Clermont Auvergne, INRAE, UNH, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Boutevilain', 'Affiliation': 'Service de médecine physique et de réadaptation, centre médicochirurgical des Massues, 69000 Lyon, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Schmitt', 'Affiliation': ""Service de médecine physique et de réadaptation, hôpital d'Instruction des Armées Desgenettes, 69000 Lyon, France.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Calmels', 'Affiliation': 'Service de médecine physique et de réadaptation, CHU Saint-Étienne, université Jean-Monnet, 42000 Saint-Étienne, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Lhoste', 'Affiliation': 'Service de radiologie, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': ""Direction de la recherche clinique et de l'innovation, unité de biostatistiques CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coudeyre', 'Affiliation': 'Service de médecine physique et de réadaptation, CHU Clermont-Ferrand, Université Clermont Auvergne, INRAE, UNH, 63000 Clermont-Ferrand, France. Electronic address: ecoudeyre@chu-clermontferrand.fr.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2021.101489']
439,33460312,The neural differences of arithmetic verification performance depend on math skill: Evidence from event-related potential.,"AIM


Math skill is a basic need for an individual, as a career prospect. However, little is known about early brain processes of arithmetic between individuals with different math skill. Therefore, we questioned the modulation of the amplitude of an early negative component by math skill level in an arithmetic verification paradigm using event-related potential (ERP).
METHODS


Thirty-six right-handed participants were assigned in two groups of high- and low-performing students. Their electroencephalogram was recorded while they completed an arithmetic verification task. Simple arithmetic operands were made by random digits from 1 to 9. Addition and subtraction operations were equally used in correct and incorrect responses. The accuracy scores, reaction times, and peak amplitude of the negativity in 200-400 ms time window were analyzed.
RESULTS


The high-performing group showed significantly higher response speeds, and they were more accurate than the low-performing group. The group × region interaction effect was significant. The high-performing group showed a significantly greater negativity, particularly in parietal region, while the low-performing group showed a significantly deeper negativity in frontal and prefrontal region. In the low-performing group, there were significant peak amplitude differences between the anterior and posterior areas. However, such differences were not detected in the high-performing group.
CONCLUSION


Students with different mathematical performance showed distinct patterns in early processing of arithmetic verification, as reflected by differences in negativity at 200-400 ms at anterior and posterior. This suggests that ERPs could be used to differentiate math mastery at neural level which is beneficial in educational and clinical contexts.",2021,"The high-performing group showed a significantly greater negativity, particularly in parietal region, while the low-performing group showed a significantly deeper negativity in frontal and prefrontal region.",['Thirty-six right-handed participants'],[],"['accuracy scores, reaction times, and peak amplitude of the negativity', 'negativity in frontal and prefrontal region']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}]",[],"[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",,0.0346758,"The high-performing group showed a significantly greater negativity, particularly in parietal region, while the low-performing group showed a significantly deeper negativity in frontal and prefrontal region.","[{'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Taghizadeh', 'Affiliation': 'Division Cognitive Neuroscience, Faculty of Education and Psychology, University of Tabriz, Tabriz, Iran.'}, {'ForeName': 'Touraj', 'Initials': 'T', 'LastName': 'Hashemi', 'Affiliation': 'Department of Psychology, Faculty of Education and Psychology, University of Tabriz, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jahan', 'Affiliation': 'Brain and Cognition Lab, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Nazari', 'Affiliation': 'Division Cognitive Neuroscience, Faculty of Education and Psychology, University of Tabriz, Tabriz, Iran.'}]",Neuropsychopharmacology reports,['10.1002/npr2.12158']
440,33458928,Pharmacological Therapy Determines the Gut Microbiota Modulation by a Pomegranate Extract Nutraceutical in Metabolic Syndrome: A Randomized Clinical Trial.,"SCOPE


Poly-pharmacological therapy shapes the gut microbiota (GM) in metabolic syndrome (MetS) patients. The effects of polyphenols in poly-medicated MetS patients are unknown.
METHODS AND RESULTS


A randomized, placebo-controlled, double-blinded, and crossover trial in poly-medicated MetS patients (n=50) explored whether the effects of a pomegranate extract nutraceutical (PE, 320 mg phenolics/day for 1 month) are affected by the drug therapy. Considering the lipid-lowering (LL-), anti-hypertensive (HP-) and(or) anti-diabetic (AD-) treatments: GM (16S rRNA sequencing), short-chain fatty acids, 40 inflammatory-metabolic and endotoxemia-related biomarkers, associations between biomarkers and GM with 53 cardiometabolic dysfunctions-related single-nucleotide polymorphisms (SNPs), and urolithin metabotypes (UMs) influence are evaluated. Representative SNPs-GM associations after PE include Lactococcus and ClostridiumXIVa with rs5443-GNB3 (G-protein-β-polypeptide-3) and ClostridiumXIVa with rs7903146-TCF7L2 (transcription-factor-7-like-2) and rs1137101-LEPR (leptin-receptor). PE decreases sICAM-1 in LL-patients and the lipopolysaccharide-binding protein in all the patients. PE does not affect the other patients' markers as a group or stratifying by UMs. After PE, Lactococcus increases in AD-, LL-, and HP-patients, Bifidobacterium increases in LL- and AD-, while Clostridium XIVa decreases in non-LL- and non-HP-patients.
CONCLUSION


The prebiotic effect of PE depends on the medication, mainly on HP-treatments. Targeting GM can complement MetS therapy, but the patients' drug therapy should be considered individually.",2021,"After PE, Lactococcus increased in AD-, LL- and HP-patients, Bifidobacterium increased in LL- and AD-, while Clostridium XIVa decreased in non-LL- and non-HP-patients.
","['poly-medicated MetS patients (n = 50', 'metabolic syndrome (MetS) patients', 'Metabolic Syndrome', 'poly-medicated MetS patients']","['lipid-lowering (LL-), anti-hypertensive (HP-) and(or) anti-diabetic (AD-) treatments: GM (16S rRNA sequencing), short-chain fatty acids', 'pomegranate extract nutraceutical (PE', 'polyphenol-rich sources', 'placebo']","['AD-, LL- and HP-patients, Bifidobacterium increased in LL- and AD-, while Clostridium XIVa', 'PE decreased sICAM-1']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C1961993', 'cui_str': 'Pomegranate Extract'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0638377,"After PE, Lactococcus increased in AD-, LL- and HP-patients, Bifidobacterium increased in LL- and AD-, while Clostridium XIVa decreased in non-LL- and non-HP-patients.
","[{'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Cortés-Martín', 'Affiliation': 'Laboratory of Food & Health, Research Group on Quality, Safety and Bioactivity of Plant Foods, CEBAS-CSIC, Campus de Espinardo, Murcia, 30100, Spain.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Iglesias-Aguirre', 'Affiliation': 'Laboratory of Food & Health, Research Group on Quality, Safety and Bioactivity of Plant Foods, CEBAS-CSIC, Campus de Espinardo, Murcia, 30100, Spain.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Meoro', 'Affiliation': 'Service of Endocrinology, Reina Sofía University Hospital, Avda. Intendente Jorge Palacios s/n, Murcia, 30003, Spain.'}, {'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'Selma', 'Affiliation': 'Laboratory of Food & Health, Research Group on Quality, Safety and Bioactivity of Plant Foods, CEBAS-CSIC, Campus de Espinardo, Murcia, 30100, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Espín', 'Affiliation': 'Laboratory of Food & Health, Research Group on Quality, Safety and Bioactivity of Plant Foods, CEBAS-CSIC, Campus de Espinardo, Murcia, 30100, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.202001048']
441,33461965,Effect of green-Mediterranean diet on intrahepatic fat: the DIRECT PLUS randomised controlled trial.,"OBJECTIVE


To examine the effectiveness of green-Mediterranean (MED) diet, further restricted in red/processed meat, and enriched with green plants and polyphenols on non-alcoholic fatty liver disease (NAFLD), reflected by intrahepatic fat (IHF) loss.
DESIGN


For the DIRECT-PLUS 18-month randomized clinical trial, we assigned 294 participants with abdominal obesity/dyslipidaemia into healthy dietary guidelines (HDG), MED and green-MED weight-loss diet groups, all accompanied by physical activity. Both isocaloric MED groups consumed 28 g/day walnuts (+440 mg/day polyphenols provided). The green-MED group further consumed green tea (3-4 cups/day) and Mankai (a  Wolffia globosa  aquatic plant strain; 100 g/day frozen cubes) green shake (+1240 mg/day total polyphenols provided). IHF% 18-month changes were quantified continuously by proton magnetic resonance spectroscopy (MRS).
RESULTS


Participants (age=51 years; 88% men; body mass index=31.3 kg/m 2 ; median IHF%=6.6%; mean=10.2%; 62% with NAFLD) had 89.8% 18-month retention-rate, and 78% had eligible follow-up MRS. Overall, NAFLD prevalence declined to: 54.8% (HDG), 47.9% (MED) and 31.5% (green-MED), p=0.012 between groups. Despite similar moderate weight-loss in both MED groups, green-MED group achieved almost double IHF% loss (-38.9% proportionally), as compared with MED (-19.6% proportionally; p=0.035 weight loss adjusted) and HDG (-12.2% proportionally; p<0.001). After 18 months, both MED groups had significantly higher total plasma polyphenol levels versus HDG, with higher detection of  Naringenin  and 2-5-dihydroxybenzoic-acid in green-MED. Greater IHF% loss was independently associated with increased Mankai and walnuts intake, decreased red/processed meat consumption, improved serum folate and adipokines/lipids biomarkers, changes in microbiome composition (beta-diversity) and specific bacteria (p<0.05 for all).
CONCLUSION


The new suggested strategy of green-Mediterranean diet, amplified with green plant-based proteins/polyphenols as Mankai, green tea, and walnuts, and restricted in red/processed meat can double IHF loss than other healthy nutritional strategies and reduce NAFLD in half.
TRIAL REGISTRATION NUMBER


NCT03020186.",2021,"Overall, NAFLD prevalence declined to: 54.8% (HDG), 47.9% (MED) and 31.5% (green-MED), p=0.012 between groups.","['294 participants with abdominal obesity/dyslipidaemia into healthy dietary guidelines (HDG), MED and green-MED weight-loss diet groups, all accompanied by physical activity']","['isocaloric MED', 'green-Mediterranean diet', 'green-Mediterranean (MED) diet, further restricted in red/processed meat, and enriched with green plants and polyphenols', 'green-Mediterranean diet, amplified with green plant-based proteins/polyphenols as Mankai, green tea, and walnuts, and restricted in red/processed meat']","['Greater IHF% loss', 'moderate weight-loss', 'Mankai and walnuts intake, decreased red/processed meat consumption, improved serum folate and adipokines/lipids biomarkers, changes in microbiome composition (beta-diversity) and specific bacteria', 'total plasma polyphenol levels', 'NAFLD prevalence', 'double IHF% loss']","[{'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0452956', 'cui_str': 'Processed meat'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0330971', 'cui_str': 'Juglans'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0330971', 'cui_str': 'Juglans'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0452956', 'cui_str': 'Processed meat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",294.0,0.0539888,"Overall, NAFLD prevalence declined to: 54.8% (HDG), 47.9% (MED) and 31.5% (green-MED), p=0.012 between groups.","[{'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Yaskolka Meir', 'Affiliation': 'Department of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Rinott', 'Affiliation': 'Department of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Department of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Department of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Department of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Rosen', 'Affiliation': 'Division of Diagnostic and Interventional Imaging, Soroka University Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Shelef', 'Affiliation': 'Division of Diagnostic and Interventional Imaging, Soroka University Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Youngster', 'Affiliation': ""Pediatric Division and Center for Microbiome Research, Shamir Medical Center, Be'er Ya'akov, Israel.""}, {'ForeName': 'Aryeh', 'Initials': 'A', 'LastName': 'Shalev', 'Affiliation': 'Division of Cardiology, Soroka Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Blüher', 'Affiliation': 'Medical Department III - Endocrinology, Nephrology, Rheumatology, Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Ceglarek', 'Affiliation': 'Institute for Laboratory Medicine, Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stumvoll', 'Affiliation': 'Medical Department III - Endocrinology, Nephrology, Rheumatology, Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Tuohy', 'Affiliation': ""Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, San Michelle All'Adige, Italy.""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Diotallevi', 'Affiliation': ""Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, San Michelle All'Adige, Italy.""}, {'ForeName': 'Urska', 'Initials': 'U', 'LastName': 'Vrhovsek', 'Affiliation': 'Faculty of Science and Technology, Free University of Bozen-Bolzano, Bolzano, Italy.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Meir', 'Initials': 'M', 'LastName': 'Stampfer', 'Affiliation': 'Department of Nutrition, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Department of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel irish@bgu.ac.il.'}]",Gut,['10.1136/gutjnl-2020-323106']
442,33822385,Pharmacokinetics of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia.,"Hypophosphatasia is a rare metabolic disease resulting from variant(s) in the gene-encoding tissue-nonspecific isozyme of alkaline phosphatase. In this 13-week, phase 2a, multicenter, randomized, open-label, dose-response study (ClinicalTrials.gov: NCT02797821), the pharmacokinetics of asfotase alfa, an enzyme replacement therapy approved for the treatment of hypophosphatasia, was assessed in adult patients with pediatric-onset hypophosphatasia. In total, 27 adults were randomly assigned 1:1:1 to a single subcutaneous dose of asfotase alfa (0.5, 2.0, or 3.0 mg/kg) during week 1. From week 3 to week 9, patients received 0.5, 2.0, or 3.0 mg/kg subcutaneously 3 times per week (equivalent to 1.5, 6.0, or 9.0 mg/kg/wk, respectively). Noncompartmental analysis revealed exposure (maximum concentration in the dosing interval and area under the concentration-time curve from time 0 to infinity) to asfotase alfa increased between single- and multiple-dose administration and with increasing doses; however, extensive interindividual variability was observed in the concentration-time profiles within each dose cohort. Median terminal elimination half-life was ≈5 days following multiple-dose administration, with steady state achieved by approximately day 29. Dose-normalized exposure data indicated that asfotase alfa activity was approximately dose-proportional within the studied dose range. Additionally, dose-normalized exposure was comparable across body mass index categories of <25, ≥25 to <30, and ≥30 kg/m 2  , indicating that asfotase alfa dosing bioavailability was consistent in these patients, including those who were obese. These data, together with previously published pharmacodynamic results in this study population, support the use of asfotase alfa at the recommended dose of 6 mg/kg/wk in adults with pediatric-onset hypophosphatasia.",2021,Dose-normalized exposure data indicated that asfotase alfa activity was approximately dose-proportional within the studied dose range.,"['adult patients with pediatric-onset hypophosphatasia', 'adults with pediatric-onset hypophosphatasia', 'Adult Patients With Pediatric-Onset Hypophosphatasia', '27 adults']","['single subcutaneous dose of asfotase alfa', 'Asfotase Alfa']","['extensive interindividual variability', 'Median terminal elimination half-life', 'asfotase alfa dosing bioavailability', 'asfotase alfa activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020630', 'cui_str': 'Hypophosphatasia'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",27.0,0.116244,Dose-normalized exposure data indicated that asfotase alfa activity was approximately dose-proportional within the studied dose range.,"[{'ForeName': 'Wei-Jian', 'Initials': 'WJ', 'LastName': 'Pan', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Rajendra', 'Initials': 'R', 'LastName': 'Pradhan', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Pelto', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Seefried', 'Affiliation': 'Orthopedic Department, University of Würzburg, Würzburg, Bavaria, Germany.'}]",Journal of clinical pharmacology,['10.1002/jcph.1870']
443,33471240,Preservation of kidney function irrelevant of total kidney volume growth rate with tolvaptan treatment in patients with autosomal dominant polycystic kidney disease.,"BACKGROUND


Tolvaptan slowed the rates of total kidney volume (TKV) growth and renal function decline over a 3-year period in patients with autosomal dominant polycystic kidney disease (ADPKD) enrolled in the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) 3:4 trial (NCT00428948). In this post hoc analysis of Japanese patients from TEMPO 3:4, we evaluated whether the effects of tolvaptan on TKV and on renal function are interrelated.
METHODS


One hundred and forty-seven Japanese patients from TEMPO 3:4 were included in this analysis (placebo, n = 55; tolvaptan, n = 92). Tolvaptan-treated patients were stratified into the responder group (n = 37), defined as tolvaptan-treated patients with a net decrease in TKV from baseline to year 3, and the non-responder group (n = 55), defined as tolvaptan-treated patients with a net increase in TKV.
RESULTS


Mean changes during follow-up in the placebo, responder, and non-responder groups were 16.99%, - 8.33%, and 13.95%, respectively, for TKV and - 12.61, - 8.47, and - 8.58 mL/min/1.73 m 2 , respectively, for estimated glomerular filtration rate (eGFR). Compared with the placebo group, eGFR decline was significantly slowed in both the responder and non-responder groups (P < 0.05).
CONCLUSION


Tolvaptan was effective in slowing eGFR decline, regardless of TKV response, over 3 years in patients with ADPKD in Japan. Treatment with tolvaptan may have beneficial effects on slowing of renal function decline even in patients who have not experienced a reduction in the rate of TKV growth by treatment with tolvaptan.",2021,"Mean changes during follow-up in the placebo, responder, and non-responder groups were 16.99%, - 8.33%, and 13.95%, respectively, for TKV and - 12.61, - 8.47, and - 8.58 ","['Japanese patients', 'One hundred and forty-seven Japanese patients from TEMPO 3:4 were included in this analysis (placebo, n\u2009=\u200955; tolvaptan, n\u2009=\u200992', 'patients with autosomal dominant polycystic kidney disease (ADPKD', 'patients with ADPKD in Japan', 'patients with autosomal dominant polycystic kidney disease']","['placebo', 'tolvaptan', 'Tolvaptan', 'tolvaptan-treated patients with a net increase in TKV', 'tolvaptan treatment']","['glomerular filtration rate (eGFR', 'slowing eGFR decline, regardless of TKV response', 'Mean changes', 'eGFR decline', 'total kidney volume (TKV) growth and renal function decline']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",147.0,0.0331217,"Mean changes during follow-up in the placebo, responder, and non-responder groups were 16.99%, - 8.33%, and 13.95%, respectively, for TKV and - 12.61, - 8.47, and - 8.58 ","[{'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Horie', 'Affiliation': 'Department of Urology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan. shorie@juntendo.ac.jp.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Muto', 'Affiliation': 'Department of Urology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Haruna', 'Initials': 'H', 'LastName': 'Kawano', 'Affiliation': 'Department of Urology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Okada', 'Affiliation': 'Department of Clinical Development, Otsuka Pharmaceutical Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Shibasaki', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nakajima', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Ibuki', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.'}]",Clinical and experimental nephrology,['10.1007/s10157-020-02009-0']
444,33452758,"Maternal physical, socioeconomic, and demographic characteristics and childbirth complications in rural lowland Nepal: Applying an evolutionary framework to understand the role of phenotypic plasticity.","OBJECTIVES


Evolutionary perspectives on human childbirth have primarily focused on characteristics of our species in general, rather than variability within and between contemporary populations. We use an evolutionary framework to explore how physical and demographic characteristics of mothers shape the risks of childbirth complications in rural lowland Nepal, where childbearing typically commences in adolescence and chronic undernutrition is widespread, though maternal overweight is increasing in association with nutrition transition.
METHODS


We conducted secondary analyses of data from a cluster-randomized trial. Women aged 14-35 years were categorized by age, number of previous pregnancies, height, body mass index (BMI), husband's education, and household wealth. Multivariable logistic regression models tested whether these characteristics independently predicted risks of episiotomy and cesarean section (CS, n = 14 261), and obstructed labor (OL, n = 5185).
RESULTS


Risks were greatest among first-time adolescent mothers, though associations with age varied by outcome. Independent of age and parity, short stature and high BMI increased risks of CS and OL, whereas associations were weaker for episiotomy. Male offspring had increased risk of CS and OL but not episiotomy. Wealth was not associated with OL, but lower wealth and lower husband's education were associated with lower likelihood of episiotomy and CS.
CONCLUSIONS


At the individual level, the risk childbirth complications is shaped by trade-offs between fertility, growth, and survival. Some biological markers of disadvantage (early childbearing, short stature) increased the risk, whereas low socio-economic status was associated with lower risk, indicating reduced access to relevant facilities. Independent of these associations, maternal age showed complex effects.",2021,"Wealth was not associated with OL, but lower wealth and lower husband's education were associated with lower likelihood of episiotomy and CS.
","[""Women aged 14-35\u2009years were categorized by age, number of previous pregnancies, height, body mass index (BMI), husband's education, and household wealth"", 'rural lowland Nepal']",[],"['Maternal physical, socioeconomic, and demographic characteristics and childbirth complications', 'risk of CS and OL', 'risk childbirth complications']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0422807', 'cui_str': 'Number of previous pregnancies'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242664', 'cui_str': 'Husband'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",,0.0437803,"Wealth was not associated with OL, but lower wealth and lower husband's education were associated with lower likelihood of episiotomy and CS.
","[{'ForeName': 'Jonathan C K', 'Initials': 'JCK', 'LastName': 'Wells', 'Affiliation': 'Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Akanksha A', 'Initials': 'AA', 'LastName': 'Marphatia', 'Affiliation': 'Department of Geography, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cortina-Borja', 'Affiliation': 'Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Dharma S', 'Initials': 'DS', 'LastName': 'Manandhar', 'Affiliation': 'Mother and Infant Research Activities, Kathmandu, Nepal.'}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Reid', 'Affiliation': 'Department of Geography, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Saville', 'Affiliation': 'UCL Institute for Global Health, London, UK.'}]",American journal of human biology : the official journal of the Human Biology Council,['10.1002/ajhb.23566']
445,33475138,Islet Function and Insulin Sensitivity in Latent Autoimmune Diabetes in Adults Taking Sitagliptin: A Randomized Trial.,"CONTEXT


The long-term effects of dipeptidyl peptidase-4 inhibitors on β-cell function and insulin sensitivity in latent autoimmune diabetes in adults (LADA) are unclear.
OBJECTIVE


To investigate the effects of sitagliptin on β-cell function and insulin sensitivity in LADA patients receiving insulin.
DESIGN AND SETTING


A randomized controlled trial at the Second Xiangya Hospital.
METHODS


Fifty-one patients with LADA were randomized to sitagliptin + insulin (SITA) group or insulin alone (CONT) group for 24 months.
MAIN OUTCOME MEASURES


Fasting C-peptide (FCP), 2-hour postprandial C-peptide (2hCP) during mixed-meal tolerance test, △CP (2hCP - FCP), and updated homeostatic model assessment of β-cell function (HOMA2-B) were determined every 6 months. In 12 subjects, hyperglycemic clamp and hyperinsulinemic euglycemic clamp (HEC) tests were further conducted at 12-month intervals.
RESULTS


During the 24-month follow-up, there were no significant changes in β-cell function in the SITA group, whereas the levels of 2hCP and △CP in the CONT group were reduced at 24 months. Meanwhile, the changes in HOMA2-B from baseline were larger in the SITA group than in the CONT group. At 24 months, first-phase insulin secretion was improved in the SITA group by hyperglycemia clamp, which was higher than in the CONT group (P < .001), while glucose metabolized (M), insulin sensitivity index, and M over logarithmical insulin ratio in HEC were increased in the SITA group (all P < .01 vs baseline), which were higher than in the CONT group.
CONCLUSION


Compared with insulin intervention alone, sitagliptin plus insulin treatment appeared to maintain β-cell function and improve insulin sensitivity in LADA to some extent.",2021,"During the 24-month follow-up, there were no significant changes in β-cell function in SITA group, whereas the levels of 2hCP and △CP in CONT group were reduced at 24 months.","['latent autoimmune diabetes in adults taking sitagliptin', 'Fifty-one patients with LADA', 'latent autoimmune diabetes in adults (LADA', 'LADA patients receiving insulin']","['sitagliptin', 'dipeptidyl peptidase-4 inhibitors', 'insulin intervention alone, sitagliptin plus insulin treatment', 'sitagliptin + insulin group (SITA group) or insulin alone group (CONT group) for 24 months']","['insulin sensitivity', 'insulin secretion', 'glucose metabolized(M), insulin sensitivity index and M over logarithmical insulin ratio in HEC', 'Fasting C-peptide (FCP), 2-hour postprandial C-peptide (2hCP) during mixed-meal tolerance test, △CP (2hCP - FCP) and updated homeostatic model assessment of β-cell function', 'β-cell function and insulin sensitivity', 'hyperglycemic clamp and hyperinsulinemic euglycemic clamp (HEC) tests', 'β-cell function', 'Islet function and insulin sensitivity']","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0443146', 'cui_str': 'Autoimmune reaction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",51.0,0.0277654,"During the 24-month follow-up, there were no significant changes in β-cell function in SITA group, whereas the levels of 2hCP and △CP in CONT group were reduced at 24 months.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Huiying', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xinyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yunjuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lingjiao', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Gan', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiangbing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Endocrinology, Metabolism and Nutrition, Rutgers University-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab026']
446,33476415,"Efficacy and safety of oral sulfate solution for bowel preparation in Japanese patients undergoing colonoscopy: Noninferiority-based, randomized, controlled study.","OBJECTIVES


To compare the efficacy and safety of oral sulfate solution administered using the same-day dose and the split-dose regimens with those of polyethylene glycol plus ascorbate solution, used for bowel preparation in Japanese patients undergoing colonoscopy.
METHODS


This multicenter (n = 13), randomized, active-controlled, colonoscopist- and image evaluator-blinded, noninferiority study with parallel-group comparison recruited 632 patients from December 2018 to June 2019. Of these, 602 patients were divided into the oral sulfate solution same-day dose group (n = 200); oral sulfate solution split-dose group (n = 202); and polyethylene glycol plus ascorbate same-day dose group (n = 200). Differences in the efficacy rates between the polyethylene glycol plus ascorbate group and each oral sulfate solution group were calculated using the asymptotic method. The safety of the oral sulfate solution was evaluated, based on the occurrence of adverse events and reactions.
RESULTS


Both oral sulfate solution protocols were confirmed as noninferior to the polyethylene glycol plus ascorbate protocol for bowel-cleansing. The occurrence of adverse reactions was significantly lower in the oral sulfate solution same-day dose group than in the polyethylene glycol plus ascorbate group (P = 0.010). The occurrence of adverse reactions was not significantly different between the oral sulfate solution split-dose and the polyethylene glycol plus ascorbate group.
CONCLUSIONS


Oral sulfate solution is not only safe and efficacious but also not inferior to polyethylene glycol plus ascorbate solution (active control). It could be used for bowel preparation in Japanese patients scheduled for colonoscopy (Clinical trial registration number: NCT03794310).",2021,The occurrence of adverse reactions was significantly lower in the oral sulfate solution same-day dose group than in the polyethylene glycol plus ascorbate group (P=0.010).,"['632 patients from December 2018 to June 2019', 'Japanese patients scheduled for colonoscopy', 'Japanese patients undergoing colonoscopy', '602 patients']","['oral sulfate solution', 'polyethylene glycol plus ascorbate solution', 'oral sulfate solution split-dose group (n=202); and polyethylene glycol plus ascorbate same-day dose group', 'polyethylene glycol plus ascorbate']","['efficacy and safety', 'Efficacy and safety', 'occurrence of adverse reactions', 'efficacy rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",,0.100286,The occurrence of adverse reactions was significantly lower in the oral sulfate solution same-day dose group than in the polyethylene glycol plus ascorbate group (P=0.010).,"[{'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Oka', 'Affiliation': 'Department of, Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Tamai', 'Affiliation': 'Department of, Endoscopy, The, Tokyo, Japan.'}, {'ForeName': 'Toyoki', 'Initials': 'T', 'LastName': 'Kudo', 'Affiliation': 'Digestive Disease Center, Showa University Northern Yokohama Hospital, Kanagawa, Japan.'}, {'ForeName': 'Nobutoshi', 'Initials': 'N', 'LastName': 'Kuniyoshi', 'Affiliation': 'Department of Internal Medicine, Kuniyoshi Hospital, Kochi, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Shirakura', 'Affiliation': 'Coloproctology Center Matsushima Hospital, Kanagawa, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Omae', 'Affiliation': 'Department of Gastroenterology, Kawasaki Saiwai Hospital, Kanagawa, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Hamahata', 'Affiliation': 'Department of Coloproctology, Tsujinaka Hospital Kashiwanoha, Chiba, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Arai', 'Affiliation': 'Gastroenterology Division, Tokatsu-Tsujinaka Hospital, Chiba, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of, Endoscopy, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Noriya', 'Initials': 'N', 'LastName': 'Uedo', 'Affiliation': 'Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Shimizu', 'Affiliation': 'Departments of Gastroenterology and Hepatology, Osaka General Hospital of West Japan Railway Company, Osaka, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Fukuzawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Uraoka', 'Affiliation': 'Department of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, Japan.'}, {'ForeName': 'Shiori', 'Initials': 'S', 'LastName': 'Ichinose', 'Affiliation': 'Nihon Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Tajiri', 'Affiliation': 'Department of, Innovative Interventional Endoscopy Research, The Jikei University School of Medicine, Tokyo, Japan.'}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.13930']
447,33507809,Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002).,"PURPOSE


Reducing radiation treatment dose could improve the quality of life (QOL) of patients with good-risk human papillomavirus-associated oropharyngeal squamous cell carcinoma (OPSCC). Whether reduced-dose radiation produces disease control and QOL equivalent to standard chemoradiation is not proven.
PATIENTS AND METHODS


In this randomized, phase II trial, patients with p16-positive, T1-T2 N1-N2b M0, or T3 N0-N2b M0 OPSCC (7th edition staging) with ≤ 10 pack-years of smoking received 60 Gy of intensity-modulated radiation therapy (IMRT) over 6 weeks with concurrent weekly cisplatin (C) or 60 Gy IMRT over 5 weeks. To be considered for a phase III study, an arm had to achieve a 2-year progression-free survival (PFS) rate superior to a historical control rate of 85% and a 1-year mean composite score ≥ 60 on the MD Anderson Dysphagia Inventory (MDADI).
RESULTS


Three hundred six patients were randomly assigned and eligible. Two-year PFS for IMRT + C was 90.5% rejecting the null hypothesis of 2-year PFS ≤ 85% ( P  = .04). For IMRT, 2-year PFS was 87.6% ( P  = .23). One-year MDADI mean scores were 85.30 and 81.76 for IMRT + C and IMRT, respectively. Two-year overall survival rates were 96.7% for IMRT + C and 97.3% for IMRT. Acute adverse events (AEs) were defined as those occurring within 180 days from the end of treatment. There were more grade 3-4 acute AEs for IMRT + C (79.6%  v  52.4%;  P  < .001). Rates of grade 3-4 late AEs were 21.3% and 18.1% ( P  = .56).
CONCLUSION


The IMRT + C arm met both prespecified end points justifying advancement to a phase III study. Higher rates of grade ≥ 3 acute AEs were reported in the IMRT + C arm.",2021,"One-year MDADI mean scores were 85.30 and 81.76 for IMRT + C and IMRT, respectively.","['HPV-Associated Oropharyngeal Carcinoma', 'Three hundred six patients were randomly assigned and eligible', 'patients with good-risk human papillomavirus-associated oropharyngeal squamous cell carcinoma (OPSCC', 'patients with p16-positive, T1-T2 N1-N2b M0, or T3 N0-N2b M0 OPSCC (7th edition staging) with ≤ 10 pack-years of smoking received']",['60 Gy of intensity-modulated radiation therapy (IMRT) over 6 weeks with concurrent weekly cisplatin (C) or 60 Gy IMRT'],"['2-year progression-free survival (PFS) rate superior', 'IMRT, 2-year PFS', 'Rates of grade 3-4 late AEs', 'Acute adverse events (AEs', 'quality of life (QOL', 'overall survival rates']","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2349952', 'cui_str': 'Oropharyngeal cancer'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0445080', 'cui_str': 'Node stage N2b'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",306.0,0.216976,"One-year MDADI mean scores were 85.30 and 81.76 for IMRT + C and IMRT, respectively.","[{'ForeName': 'Sue S', 'Initials': 'SS', 'LastName': 'Yom', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Torres-Saavedra', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Jimmy J', 'Initials': 'JJ', 'LastName': 'Caudell', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Waldron', 'Affiliation': 'University Health Network-Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Gillison', 'Affiliation': 'M D Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Xia', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Minh T', 'Initials': 'MT', 'LastName': 'Truong', 'Affiliation': 'Boston Medical Center, Boston, MA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kong', 'Affiliation': 'Stanford Cancer Institute Palo Alto, Stanford, CA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jordan', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Rathan M', 'Initials': 'RM', 'LastName': 'Subramaniam', 'Affiliation': 'Otago Medical School, Dunedin, New Zealand.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'University Hospitals Cleveland, Cleveland, OH.'}, {'ForeName': 'Christine H', 'Initials': 'CH', 'LastName': 'Chung', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Geiger', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Chan', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': ""O'Sullivan"", 'Affiliation': 'University Health Network-Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Dukagjin M', 'Initials': 'DM', 'LastName': 'Blakaj', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Loren K', 'Initials': 'LK', 'LastName': 'Mell', 'Affiliation': 'UC San Diego Moores Cancer Center, La Jolla, CA.'}, {'ForeName': 'Wade L', 'Initials': 'WL', 'LastName': 'Thorstad', 'Affiliation': 'Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Christopher U', 'Initials': 'CU', 'LastName': 'Jones', 'Affiliation': 'Sutter Cancer Research Consortium, Sacramento, CA.'}, {'ForeName': 'Robyn N', 'Initials': 'RN', 'LastName': 'Banerjee', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, AB, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lominska', 'Affiliation': 'University of Kansas Cancer Center, Kansas City, KS.'}, {'ForeName': 'Quynh-Thu', 'Initials': 'QT', 'LastName': 'Le', 'Affiliation': 'Stanford University, Stanford, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.03128']
448,33514787,Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial.,"The aim of this trial was to determine whether a toothpaste with microcrystalline hydroxyapatite is not inferior to a fluoride toothpaste in prevention of caries in children. This double-blinded randomized control trial compared two toothpastes regarding the occurrence of caries lesions using International Caries Detection and Assessment System (ICDAS) ≥ code 1 on the primary dentition within 336 days. The test group used a fluoride-free hydroxyapatite toothpaste three times daily while control group used a toothpaste with fluoride. 207 children were included in the intention-to-treat analysis; 177 of them finished the study per protocol. An increase in caries ICDAS ≥ code 1 per tooth was observed in 72.7% of the hydroxyapatite-group (n = 88), compared with 74.2% of the fluoride-group (n = 89). The exact one-sided upper 95% confidence limit for the difference in proportion of participants with ICDAS increase ≥ 1 (-1.4%) was 9.8%, which is below the non-inferiority margin of 20% demonstrating non-inferiority of hydroxyapatite compared to the fluoride control toothpaste. This RCT showed for the first time, that in children, the impact of the daily use of a toothpaste with microcrystalline hydroxyapatite on enamel caries progression in the primary dentition is not inferior to a fluoride control toothpaste (Clinical Trials NCT03553966).",2021,"An increase in caries ICDAS ≥ code 1 per tooth was observed in 72.7% of the hydroxyapatite-group (n = 88), compared with 74.2% of the fluoride-group (n = 89).","['207 children were included in the intention-to-treat analysis; 177 of them finished the study per protocol', 'primary dentition within 336\xa0days', 'caries in children']","['toothpaste with microcrystalline hydroxyapatite', 'fluoride-free hydroxyapatite toothpaste three times daily while control group used a toothpaste with fluoride', 'hydroxyapatite', 'fluoride toothpaste']","['occurrence of early childhood caries', 'caries ICDAS\u2009≥\u2009code 1 per tooth', 'enamel caries progression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",207.0,0.347342,"An increase in caries ICDAS ≥ code 1 per tooth was observed in 72.7% of the hydroxyapatite-group (n = 88), compared with 74.2% of the fluoride-group (n = 89).","[{'ForeName': 'Elzbieta', 'Initials': 'E', 'LastName': 'Paszynska', 'Affiliation': 'Department of Integrated Dentistry, Poznan University of Medical Sciences, Poznan, Poland. paszynska@ump.edu.pl.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Pawinska', 'Affiliation': 'Department of Integrated Dentistry, Medical University of Bialystok, Białystok, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gawriolek', 'Affiliation': 'Department of Integrated Dentistry, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Kaminska', 'Affiliation': 'Department of Integrated Dentistry, Medical University of Bialystok, Białystok, Poland.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Otulakowska-Skrzynska', 'Affiliation': 'Department of Integrated Dentistry, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Grazyna', 'Initials': 'G', 'LastName': 'Marczuk-Kolada', 'Affiliation': 'Department of Pedodontics, Medical University of Bialystok, Białystok, Poland.'}, {'ForeName': 'Szymon', 'Initials': 'S', 'LastName': 'Rzatowski', 'Affiliation': 'Department of Integrated Dentistry, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Sokolowska', 'Affiliation': 'Department of Pedodontics, Medical University of Bialystok, Białystok, Poland.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Olszewska', 'Affiliation': 'Department of Facial Malformation, Pediatric Dentistry Clinic, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schlagenhauf', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Theodor W', 'Initials': 'TW', 'LastName': 'May', 'Affiliation': 'Society for Biometrics and Psychometrics, Bielefeld, Germany.'}, {'ForeName': 'Bennett T', 'Initials': 'BT', 'LastName': 'Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Elzbieta', 'Initials': 'E', 'LastName': 'Luczaj-Cepowicz', 'Affiliation': 'Department of Pedodontics, Medical University of Bialystok, Białystok, Poland.'}]",Scientific reports,['10.1038/s41598-021-81112-y']
449,33520849,Evaluation of the effectiveness of Persian diabetes self-management education in older adults with type 2 diabetes at a diabetes outpatient clinic in Tehran: a pilot randomized control trial.,"Purpose


The effectiveness of diabetes self-management interventions has been more generally demonstrated in adults, but there is little evidence of diabetes self-management specific to older adults situated in Iran. The purpose of this study was to evaluate the effectiveness of Persian Diabetes Self-Management Education on self-efficacy, quality of life, self-care activity, depression and loneliness in older adults with type 2 diabetes.
Methods


In pilot randomized controlled trial, a total of 34 participants ≥60 years with type 2 diabetes were randomly assigned into intervention ( n  = 17) and control (n = 17) group in an outpatient diabetes clinic in Tehran. To assess the primary outcome of participant experiences, the Diabetes Management Self-efficacy Scale (DMSES) was the method of measurement. The Diabetes Quality of Life-Basic Clinical Inventory (DQoL-BCI), Patient Health Questionnaire-9 (PHQ-9), Diabetes Self-Management Education Scale (DSMES), and adult Social-Emotional Loneliness Scale Short form (SELSA-S) were used as secondary outcomes. Participants' evaluations were completed at baseline, while measurements were conducted two and four weeks after allocation, using repeated measurements of Univariate and multivariate ANOVA (adjusted for baseline values) to analyze the data.
Results


In the multivariate model, there was a significant difference between the control and intervention groups regarding reported quality of life ( p  = 0.04) and the medical-domain's reported self-efficacy ( p  = 0.02). However, there were no significant differences in the reported self-management, depression, loneliness, as well as the other domain of self-efficacy; as compared between the two groups before and after intervention.
Conclusion


The study depicts a promising impact on older adults, imparted by the pertinent program. The finding showed PDSME has a positive effect on quality of life and medical control domain of self-efficacy. This pilot study showed that the program is feasible and duly beneficial if delivered to older adults. This pilot proves appealing to begin further testing within a larger sample population.",2020,"However, there were no significant differences in the reported self-management, depression, loneliness, as well as the other domain of self-efficacy; as compared between the two groups before and after intervention.
","['34 participants ≥60\xa0years with type 2 diabetes', 'older adults with type 2 diabetes', 'older adults', 'older adults with type 2 diabetes at a diabetes outpatient clinic in Tehran']","['control (n\u2009=\u200917) group in an outpatient diabetes clinic in Tehran', 'Persian Diabetes Self-Management Education', 'Persian diabetes self-management education', 'diabetes self-management interventions']","['Diabetes Quality of Life-Basic Clinical Inventory (DQoL-BCI), Patient Health Questionnaire-9 (PHQ-9), Diabetes Self-Management Education Scale (DSMES), and adult Social-Emotional Loneliness Scale Short form (SELSA-S', 'self-efficacy, quality of life, self-care activity, depression and loneliness', 'reported self-management, depression, loneliness, as well as the other domain of self-efficacy', 'Diabetes Management Self-efficacy Scale (DMSES', 'quality of life and medical control domain of self-efficacy', 'quality of life', 'self-efficacy']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0012384', 'cui_str': 'Succimer'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",34.0,0.0438925,"However, there were no significant differences in the reported self-management, depression, loneliness, as well as the other domain of self-efficacy; as compared between the two groups before and after intervention.
","[{'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Saghaee', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Ghahari', 'Affiliation': ""School of Rehabilitation Therapy 31 George Street, Queen's University Kingston, Kingston, Ontario Canada.""}, {'ForeName': 'Ensieh', 'Initials': 'E', 'LastName': 'Nasli-Esfahani', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Sharifi', 'Affiliation': 'Elderly Health Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Alizadeh-Khoei', 'Affiliation': 'Gerontology &Geriatric department, Medical school, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Rezaee', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00684-0']
450,33497252,Prostate-Only Versus Whole-Pelvic Radiation Therapy in High-Risk and Very High-Risk Prostate Cancer (POP-RT): Outcomes From Phase III Randomized Controlled Trial.,"PURPOSE


We report the clinical outcomes of a randomized trial comparing prophylactic whole-pelvic nodal radiotherapy to prostate-only radiotherapy (PORT) in high-risk prostate cancer.
METHODS


This phase III, single center, randomized controlled trial enrolled eligible patients undergoing radical radiotherapy for node-negative prostate adenocarcinoma, with estimated nodal risk ≥ 20%. Randomization was 1:1 to PORT (68 Gy/25# to prostate) or whole-pelvic radiotherapy (WPRT, 68 Gy/25# to prostate, 50 Gy/25# to pelvic nodes, including common iliac) using computerized stratified block randomization, stratified by Gleason score, type of androgen deprivation, prostate-specific antigen at diagnosis, and prior transurethral resection of the prostate. All patients received image-guided, intensity-modulated radiotherapy and minimum 2 years of androgen deprivation therapy. The primary end point was 5-year biochemical failure-free survival (BFFS), and secondary end points were disease-free survival (DFS) and overall survival (OS).
RESULTS


From November 2011 to August 2017, a total of 224 patients were randomly assigned (PORT = 114, WPRT = 110). At a median follow-up of 68 months, 36 biochemical failures (PORT = 25, WPRT = 7) and 24 deaths (PORT = 13, WPRT = 11) were recorded. Five-year BFFS was 95.0% (95% CI, 88.4 to 97.9) with WPRT versus 81.2% (95% CI, 71.6 to 87.8) with PORT, with an unadjusted hazard ratio (HR) of 0.23 (95% CI, 0.10 to 0.52;  P  < .0001). WPRT also showed higher 5-year DFS (89.5%  v  77.2%; HR, 0.40; 95% CI, 0.22 to 0.73;  P  = .002), but 5-year OS did not appear to differ (92.5%  v  90.8%; HR, 0.92; 95% CI, 0.41 to 2.05;  P  = .83). Distant metastasis-free survival was also higher with WPRT (95.9%  v  89.2%; HR, 0.35; 95% CI, 0.15 to 0.82;  P  = .01). Benefit in BFFS and DFS was maintained across prognostic subgroups.
CONCLUSION


Prophylactic pelvic irradiation for high-risk, locally advanced prostate cancer improved BFFS and DFS as compared with PORT, but OS did not appear to differ.",2021,"CONCLUSION


Prophylactic pelvic irradiation for high-risk, locally advanced prostate cancer improved BFFS and DFS as compared with PORT, but OS did not appear to differ.","['From November 2011 to August 2017, a total of 224 patients were randomly assigned (PORT = 114, WPRT = 110', 'for node-negative prostate adenocarcinoma, with estimated nodal risk ≥ 20', 'High-Risk and Very High-Risk Prostate Cancer (POP-RT', 'high-risk prostate cancer']","['radical radiotherapy', 'Prostate-Only Versus Whole-Pelvic Radiation Therapy', 'whole-pelvic radiotherapy (WPRT', 'Prophylactic pelvic irradiation', 'WPRT', 'image-guided, intensity-modulated radiotherapy and minimum 2 years of androgen deprivation therapy', 'prophylactic whole-pelvic nodal radiotherapy to prostate-only radiotherapy (PORT']","['Distant metastasis-free survival', '5-year DFS', '5-year biochemical failure-free survival (BFFS), and secondary end points were disease-free survival (DFS) and overall survival (OS', '5-year OS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",224.0,0.264868,"CONCLUSION


Prophylactic pelvic irradiation for high-risk, locally advanced prostate cancer improved BFFS and DFS as compared with PORT, but OS did not appear to differ.","[{'ForeName': 'Vedang', 'Initials': 'V', 'LastName': 'Murthy', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Priyamvada', 'Initials': 'P', 'LastName': 'Maitre', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Sadhana', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Clinical Research Secretariat, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Gitanjali', 'Initials': 'G', 'LastName': 'Panigrahi', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Krishnatry', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Bakshi', 'Affiliation': 'Department of Surgery, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Prakash', 'Affiliation': 'Department of Surgery, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Mahendra', 'Initials': 'M', 'LastName': 'Pal', 'Affiliation': 'Department of Surgery, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Menon', 'Affiliation': 'Department of Pathology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Phurailatpam', 'Affiliation': 'Department of Medical Physics, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Smruti', 'Initials': 'S', 'LastName': 'Mokal', 'Affiliation': 'Clinical Research Secretariat, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Chaurasiya', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Popat', 'Affiliation': 'Department of Radiodiagnosis, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Sable', 'Affiliation': 'Department of Radiodiagnosis, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Archi', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Rangarajan', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Mahantshetty', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.03282']
451,33504953,Effects of aspirin on the long-term management of depression in older people: a double-blind randomised placebo-controlled trial.,"Late-life depression is common and often inadequately managed using existing therapies. Depression is also associated with increased markers of inflammation, suggesting a potential role for anti-inflammatory agents. ASPREE-D is a sub-study of ASPREE, a large multi-centre, population-based, double-blind, placebo-controlled trial of aspirin vs placebo in older Australian and American adults (median follow-up: 4.7 years) of whom 1879 were depressed at baseline. Participants were given 100 mg daily dose of aspirin or placebo. Depressive symptoms were assessed annually using the validated, self-rated short version of the Center for Epidemiological Studies Depression scale. There was a significant increase in depressive scores (0.6; 95% CI 0.2 to 0.9; χ 2  (1) = 10.37; p = 0.001) and a decreased score in the mental health component of a quality of life scale (-0.7; 95% CI -1.4 to -0.1; χ 2  (1) = 4.74; p = 0.029) in the aspirin group compared to the placebo group. These effects were greater in the first year of follow-up and persisted throughout the study, albeit with small to very small effect sizes. This study failed to demonstrate any benefit of aspirin in the long-term course of depression in this community-dwelling sample of older adults over a 5-year period, and identified an adverse effect of aspirin in the course of depression in those with pre-existing depressive symptoms.",2021,There was a significant increase in depressive scores (0.6; 95% CI 0.2 to 0.9; χ 2  (1) = 10.37; p = 0.001) and a decreased score in the mental health component of a quality of life scale (-0.7; 95% CI -1.4 to -0.1; χ 2  (1) = 4.74; p = 0.029) in the aspirin group compared to the placebo group.,"['older Australian and American adults (median follow-up: 4.7 years) of whom 1879 were depressed at baseline', 'older people']","['aspirin', 'aspirin vs placebo', 'aspirin or placebo', 'placebo']","['depressive scores', 'Depressive symptoms', 'mental health component of a quality of life scale']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",1879.0,0.601358,There was a significant increase in depressive scores (0.6; 95% CI 0.2 to 0.9; χ 2  (1) = 10.37; p = 0.001) and a decreased score in the mental health component of a quality of life scale (-0.7; 95% CI -1.4 to -0.1; χ 2  (1) = 4.74; p = 0.029) in the aspirin group compared to the placebo group.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': ""Deakin University, IMPACT - the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, 75 Pigdon's Road, Waurn Ponds, Geelong, VIC, 3216, Australia. mikebe@barwonhealth.org.au.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Agustini', 'Affiliation': ""Deakin University, IMPACT - the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, 75 Pigdon's Road, Waurn Ponds, Geelong, VIC, 3216, Australia.""}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, 7000, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Department of Family Medicine and the Rush Alzheimer's Disease Center, Rush University Medical Center, 600 South Paulina, Suite 1022, Chicago, IL, 60612, USA.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Sharyn M', 'Initials': 'SM', 'LastName': 'Fitzgerald', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': ""Deakin University, IMPACT - the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, 75 Pigdon's Road, Waurn Ponds, Geelong, VIC, 3216, Australia.""}, {'ForeName': 'Seetal', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': ""Deakin University, IMPACT - the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, 75 Pigdon's Road, Waurn Ponds, Geelong, VIC, 3216, Australia.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes & Clinical Research, Hennepin County Medical Center, Minneapolis, MN, 55404, USA.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stocks', 'Affiliation': 'Discipline of General Practice, Adelaide Medical School, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash University Department of Psychiatry, The Epworth Clinic, Camberwell, VIC, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mazza', 'Affiliation': ""Deakin University, IMPACT - the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, 75 Pigdon's Road, Waurn Ponds, Geelong, VIC, 3216, Australia.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}]",Molecular psychiatry,['10.1038/s41380-021-01020-5']
452,33527576,"Antiperistaltic effect and safety of l-menthol oral solution on gastric mucosa for upper gastrointestinal endoscopy in Chinese patients: Phase III, multicenter, randomized, double-blind, placebo-controlled study.","OBJECTIVE


The topical antispasmodic agent l-menthol is commonly used for gastric peristalsis suppression during diagnostic upper gastrointestinal (GI) endoscopy. We evaluated the efficacy and safety of a single dose l-menthol solution in suppressing gastric peristalsis during upper GI endoscopy in Chinese patients.
METHODS


In this phase III, multicenter, randomized, double-blind, placebo-controlled study (ClinicalTrials.gov: NCT03263910), 220 patients scheduled to undergo upper GI endoscopy at five Chinese referral centers received a single dose of either 160 mg of l-menthol (n = 109) or placebo (n = 111). Both treatments were sprayed endoscopically on the gastric mucosa. An independent committee evaluated the degree of gastric peristalsis (peristaltic score: grade 1-5).
RESULTS


At baseline, the proportion of patients with grade 1 peristalsis (no peristalsis) did not differ between the groups. The proportion of patients with grade 1 peristalsis post-treatment was significantly higher in the l-menthol group (40.37%, 44/109) versus the placebo group (16.22%, 18/111; P < 0.001); the difference between the groups was 24.15% (95% confidence interval: 12.67%-35.63%; P < 0.001). In the l-menthol group, 61.47% of patients had grade 1 peristalsis after endoscopy versus 24.55% in the placebo group (P < 0.001). The ease of intragastric examination correlated significantly with the grade of peristalsis. The incidence of adverse events was comparable between the groups (P = 0.340).
CONCLUSIONS


During upper GI endoscopy, a single dose of l-menthol solution (160 mg) sprayed on the gastric mucosa significantly attenuated gastric peristalsis versus placebo, thereby improving the visual stability without any safety concerns.",2021,"The proportion of patients with grade 1 peristalsis post-treatment was significantly higher in the L-menthol group (40.37%, 44/109) versus the placebo group (16.22%, 18/111; P<0.001); the difference between the groups was 24.15% (95% confidence interval: 12.67%-35.63%; P<0.001).","['Chinese patients', '220 patients scheduled to undergo upper GI endoscopy at five Chinese referral centers', 'Chinese Patients']","['L-menthol solution', 'L-menthol', 'placebo', 'L-menthol Oral Solution', 'Placebo']","['proportion of patients with grade 1 peristalsis post-treatment', 'efficacy and safety', 'incidence of adverse events', 'visual stability']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0771655', 'cui_str': 'LEVOMENTHOL'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031133', 'cui_str': 'Peristalsis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",220.0,0.49273,"The proportion of patients with grade 1 peristalsis post-treatment was significantly higher in the L-menthol group (40.37%, 44/109) versus the placebo group (16.22%, 18/111; P<0.001); the difference between the groups was 24.15% (95% confidence interval: 12.67%-35.63%; P<0.001).","[{'ForeName': 'Fandong', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fachao', 'Initials': 'F', 'LastName': 'Zhi', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhaoshen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital Affiliated to the Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhanxiong', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': 'Department of Gastroenterology, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Shuixiang', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Gastroenterology, The First Affiliated Hospital of Xi'an Jiaotong University, Xian, China.""}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yingxuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Xiangbin', 'Initials': 'X', 'LastName': 'Xing', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Department of Medical Statistics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yongdong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shutian', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.13941']
453,33495294,The Effect of Exenatide Once Weekly on Carotid Atherosclerosis in Individuals With Type 2 Diabetes: An 18-Month Randomized Placebo-Controlled Study.,"OBJECTIVE


Glucagon-like peptide 1 receptor agonists (GLP-1RAs) improved multiple proatherogenic risk factors and reduced cardiovascular events in recent clinical trials, suggesting that they may slow progression of atherosclerosis. We tested whether exenatide once weekly reduces carotid plaque progression in individuals with type 2 diabetes.
RESEARCH DESIGN AND METHODS


In a double-blind, pragmatic trial, 163 participants were randomized (2:1) to exenatide ( n  = 109) or placebo ( n  = 54). Changes in carotid plaque volume and composition were measured at 9 and 18 months by multicontrast 3 Tesla MRI. Fasting and post-high-fat meal plasma glucose and lipids, and endothelial function responses, were measured at 3, 9, and 18 months.
RESULTS


Exenatide reduced hemoglobin A 1c  (HbA 1c ) (estimated difference vs. placebo 0.55%,  P  = 0.0007) and fasting and postmeal plasma glucose (19 mg/dL,  P  = 0.0002, and 25 mg/dL,  P  < 0.0001, respectively). Mean (SD) change in plaque volume in the exenatide group (0.3% [2%]) was not different from that in the placebo group (-2.2% [8%]) ( P  = 0.4). The change in plaque volume in the exenatide group was associated with changes in HbA 1c  ( r  = 0.38,  P  = 0.0004), body weight, and overall plasma glucose ( r  = 0.29,  P  = 0.007 both). There were no differences in changes in plaque composition, body weight, blood pressure, fasting and postmeal plasma triglycerides, and endothelial function between the groups.
CONCLUSIONS


Exenatide once weekly for up to 18 months improved fasting and postprandial glycemic control but did not modify change in carotid plaque volume or composition. This study raises the possibility that short-term antiatherosclerotic effects may not play a central role in the cardiovascular benefits of GLP-1RAs.",2021,"There were no differences in changes in plaque composition, body weight, blood pressure, fasting and postmeal plasma triglycerides, and endothelial function between the groups.
","['163 participants', 'Individuals With Type 2 Diabetes', 'individuals with type 2 diabetes']","['placebo', 'exenatide', 'Placebo', 'Glucagon-like peptide 1 receptor agonists (GLP-1RAs', 'Exenatide']","['plaque composition, body weight, blood pressure, fasting and postmeal plasma triglycerides, and endothelial function', 'body weight, and overall plasma glucose', 'fasting and postprandial glycemic control', 'hemoglobin', 'Mean (SD) change in plaque volume', 'Fasting and post-high-fat meal plasma glucose and lipids, and endothelial function responses', 'carotid plaque volume or composition', 'carotid plaque progression', 'fasting and postmeal plasma glucose', 'plaque volume', 'Carotid Atherosclerosis', 'carotid plaque volume and composition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}]",163.0,0.296023,"There were no differences in changes in plaque composition, body weight, blood pressure, fasting and postmeal plasma triglycerides, and endothelial function between the groups.
","[{'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Koska', 'Affiliation': 'Phoenix Veterans Affairs Health Care System, Phoenix, AZ juraj.koska@va.gov.'}, {'ForeName': 'Raymond Q', 'Initials': 'RQ', 'LastName': 'Migrino', 'Affiliation': 'Phoenix Veterans Affairs Health Care System, Phoenix, AZ.'}, {'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Chan', 'Affiliation': 'Phoenix Veterans Affairs Health Care System, Phoenix, AZ.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Cooper-Cox', 'Affiliation': 'Phoenix Veterans Affairs Health Care System, Phoenix, AZ.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Reaven', 'Affiliation': 'Phoenix Veterans Affairs Health Care System, Phoenix, AZ.'}]",Diabetes care,['10.2337/dc20-2014']
454,33501854,The Effects of Computerized Versus Collaborative Professional Development on Teachers' and Students' Performance Related to the Concept Anchoring Routine.,"Two studies investigated the effects of a live, collaborative Professional Development (PD) program versus individualized PD with a multimedia software program. For both studies, teachers were randomly assigned to either a Virtual Workshop (VW) group that used the software program or to an Actual Workshop (AW) group that participated in a face-to-face workshop that included collaborative activities. The same teaching routine, the Concept Anchoring Routine, was taught to the teachers in both studies. In Study 1, teachers' scores on a knowledge test about the routine and written plans for using the routine significantly improved from pretest to posttest in both groups. The groups' posttest scores were not significantly different. Similarly, in Study 2, both groups' posttest scores with regard to their knowledge of the routine, their written plans for use of the routine, and their implementation of the routine in their classes were significantly higher than their baseline scores. There were no differences between the teacher groups after training. The posttest knowledge scores of the whole groups of students being taught by both groups of teachers were also significantly higher than their pretest scores. Similar significant results were achieved by the students with LD. Moreover, the whole groups of students of VW teachers earned significantly higher posttest scores than the whole groups of students of AW teachers. Both teacher groups were satisfied with the training they received and with the routine. The students of both groups were satisfied with the way their teachers used the routine to help them learn.",2021,"In Study 1, teachers' scores on a knowledge test about the routine and written plans for using the routine significantly improved from pretest to posttest in both groups.",[],"['Virtual Workshop (VW) group that used the software program or to an Actual Workshop (AW) group that participated in a face-to-face workshop that included collaborative activities', 'live, collaborative Professional Development (PD) program versus individualized PD with a multimedia software program', 'Computerized Versus Collaborative Professional Development']",['posttest knowledge scores'],[],"[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0103921,"In Study 1, teachers' scores on a knowledge test about the routine and written plans for using the routine significantly improved from pretest to posttest in both groups.","[{'ForeName': 'Jean B', 'Initials': 'JB', 'LastName': 'Schumaker', 'Affiliation': 'Edge Enterprises, Inc., Lawrence, KS, USA.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Walsh', 'Affiliation': 'Autism, Behavior, and Psychology Services, Shawnee, KS, USA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Fisher', 'Affiliation': 'Grand Valley State University, Grand Rapids, MI, USA.'}, {'ForeName': 'Patricia Sampson', 'Initials': 'PS', 'LastName': 'Graner', 'Affiliation': 'KU Center for Research on Learning, Lawrence, KS, USA.'}]",Journal of learning disabilities,['10.1177/0022219420988001']
455,33508496,Mathematical Characterization of Changes in Fear During Exposure Therapy.,"BACKGROUND


During exposure therapy, patients report increases in fear that generally decrease within and across exposure sessions. Our main aim was to characterize these changes in fear ratings mathematically; a secondary aim was to test whether the resulting model would help to predict treatment outcome.
METHODS


We applied tools of computational psychiatry to a previously published dataset in which 30 women with spider phobia were randomly assigned to virtual-reality exposures in a single context or in multiple contexts (n = 15 each). Patients provided fear ratings every minute during exposures. We characterized fear decrease within exposures and return of fear between exposures using a set of mathematical models; we selected the best model using Bayesian techniques. In the multiple-contexts group, we tested the predictions of the best model in a separate, test exposure, and we investigated the ability of model parameters to predict treatment outcome.
RESULTS


The best model characterized fear decrease within exposures in both groups as an exponential decay with constant decay rate across exposures. The best model for each group had only two parameters but captured with remarkable accuracy the patterns of fear change, both at the group level and for individual subjects. The best model also made remarkably accurate predictions for the test exposure. One of the model's parameters helped predict treatment outcome.
CONCLUSIONS


Individual patterns of fear change during exposure therapy can be characterized mathematically. This mathematical characterization helps predict treatment outcome.",2021,"The best model for each group had only two parameters but captured with remarkable accuracy the patterns of fear change, both at the group level and for individual subjects.",['30 women with spider phobia'],['virtual-reality exposures in a single context or in multiple contexts'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",[],30.0,0.0187306,"The best model for each group had only two parameters but captured with remarkable accuracy the patterns of fear change, both at the group level and for individual subjects.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Portêlo', 'Affiliation': 'Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Shiban', 'Affiliation': 'Department of Psychology (Clinical Psychology and Psychotherapy Research), PFH Private University of Applied Sciences, Göttingen, Germany.'}, {'ForeName': 'Tiago V', 'Initials': 'TV', 'LastName': 'Maia', 'Affiliation': 'Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal. Electronic address: tiago.v.maia@gmail.com.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2021.01.005']
456,33523688,Social sampling: Children track social choices to reason about status hierarchies.,"We tested whether preschool-aged children (N = 280) track an agents' choices of individuals from novel social groups (i.e., social choices) to infer an agent's social preferences and the social status of the groups. Across experiments, children saw a box containing 2 groups (red and blue toy cats). In Experiment 1, children were randomly assigned to Social Selection in which items were described as ""friends,"" or to Object Selection in which items were described as ""toys."" Within each selection type, the agent selected 5 items from either a numerically common group (82% of box; selections appearing random) or a numerically rare group (18% of box; selections violating random sampling). After watching these selections, children were asked who the agent would play with among 3 individuals: 1 from the selected group, 1 from the unselected group, or 1 from a novel group. Only participants who viewed Social Selection of a numerically rare group predicted that the agent would select an individual from that group in the future. These participants also said an individual from the selected group was the ""leader."" Subsequent experiments further probed the Social Selection findings. Children's reasoning depended on the agent actively selecting the friends (Experiment 2), and children thought a member of the rare selected group was the leader, but not the ""helper"" (Experiment 3). These results illustrate that children track an agent's positive social choices to reason about that agent's social preferences and to infer the status (likelihood of being a leader) of novel social groups. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Children's reasoning depended on the agent actively selecting the friends (Experiment 2), and children thought a member of the rare selected group was the leader, but not the ""helper"" (Experiment 3).","[""preschool-aged children (N = 280) track an agents' choices of individuals from novel social groups (i.e., social choices) to infer an agent's social preferences and the social status of the groups""]","['friends,"" or to Object Selection in which items were described as ""toys', 'Social sampling']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0687744', 'cui_str': 'Social group'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0699806', 'cui_str': 'Social status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]",[],,0.0112442,"Children's reasoning depended on the agent actively selecting the friends (Experiment 2), and children thought a member of the rare selected group was the leader, but not the ""helper"" (Experiment 3).","[{'ForeName': 'Isobel A', 'Initials': 'IA', 'LastName': 'Heck', 'Affiliation': 'Department of Psychology, University of Chicago.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Kushnir', 'Affiliation': 'Department of Human Development, Cornell University.'}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Kinzler', 'Affiliation': 'Department of Psychology, University of Chicago.'}]",Journal of experimental psychology. General,['10.1037/xge0001008']
457,33538643,Does a Previsit Phone Call from the Surgeon Reduce Decision Conflict?,"Background:  There is some evidence that previsit strategies can make in-person visits more productive and efficient. We compared between people who received a phone call before a musculoskeletal specialty visit and people who did not with respect to several factors: (1) decision conflict (difficulty deciding between two or more options), (2) perceived clinician empathy after an in-person visit, and (3) arrival for the scheduled in-person appointment. We also recorded the specialist's opinion that the phone call alone could adequately replace an in-person visit while maintaining quality, safety, and effectiveness.  Materials and Methods:  In this prospective randomized-controlled trial, 122 patients were enrolled and randomized to receive a previsit phone call by an orthopedic surgeon before a scheduled visit or not. After the in-person visit, patients completed a (1) demographic questionnaire including age, gender, race/ethnicity, marital status, level of education, work status, and comorbidities; (2) Decision Conflict Scale; and (3) Jefferson Scale of Patient Perceptions of Physician Empathy.  Results:  No significant difference was found between the two groups in decision conflict, perceived empathy, or not attending the scheduled visit. Of the 55 successful phone calls, the surgeon felt that 50 (91%) had the potential to safely and effectively replace an in-person visit.  Conclusion : Although a previsit phone call did not reduce decision conflict or improve the patient experience as measured after one visit, there may be merit in studying an increased number of touch points, particularly with some subsets of illness featuring substantial stress or misconceptions. The identified potential for the application and transfer of specialty expertise through telephone alone also merits additional study.",2021,"No significant difference was found between the two groups in decision conflict, perceived empathy, or not attending the scheduled visit.",['122 patients'],"['phone call before a musculoskeletal specialty visit and people who did not with respect to several factors: (1) decision conflict (difficulty deciding between two or more options), (2) perceived clinician empathy after an in-person visit, and (3) arrival for the scheduled in-person appointment', 'previsit phone call by an orthopedic surgeon before a scheduled visit or not']","['decision conflict, perceived empathy, or not attending the scheduled visit', 'potential to safely and effectively replace an in-person visit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}]","[{'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0559294', 'cui_str': 'Did not attend'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",122.0,0.0796562,"No significant difference was found between the two groups in decision conflict, perceived empathy, or not attending the scheduled visit.","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Versluijs', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School-The University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Brown', 'Affiliation': 'Center for Health Communication, Dell Medical School-The University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ring', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School-The University of Texas at Austin, Austin, Texas, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0475']
458,33502265,Reducing Barriers to Behavioral Treatments for Insomnia: A Qualitative Examination of Veterans' Perspectives of BBTI.,"Objective:  Although behavioral treatments are recommended for treating insomnia disorder, these treatments are not the most commonly provided treatments due to numerous barriers (e.g., treatment length, time limitations). Brief Behavioral Treatment for Insomnia (BBTI) was developed, in part, to help overcome these barriers. The purpose of the current study was to qualitatively examine the treatment experiences of veterans with insomnia disorder participating in BBTI. Methods:  All veterans (n=46) who were randomized to receive BBTI as part of a randomized clinical trial participated in 10-20 minute semi-structured interviews one week after completing treatment. Rapid analysis procedures were used for qualitative analysis. Results:  Thirteen qualitative themes were identified: BBTI provided veterans with the skills they believed they needed to continue improving independently post-treatment; beginning BBTI with in-person sessions was valued; phone sessions helped participation; veterans did not perceive that they could cover the same content during phone and in-person sessionsl; materials could be more portable; BBTI created accountability; BBTI required discipline and willingness; BBTI facilitated buy-in; BBTI was aligned with military culture; loved ones could provide important support; BBTI could be improved with more personalization; BBTI challenged expectations of mental health; and BBTI improved awareness of health behaviors beyond sleep. Conclusions:  BBTI was successful in overcoming barriers to behavioral insomnia treatment and interviews identified critical treatment aspects that should be maintained to preserve acceptability (e.g., in-person session first). Areas in which BBTI did not fully meet the needs of veterans and targets for improvement (e.g., ameliorating understanding and expectations of phone sessions) were also identified.",2021,Thirteen qualitative themes were identified: BBTI provided veterans with the skills they believed they needed to continue improving independently post-treatment; beginning BBTI with in-person sessions was valued; phone sessions helped participation; veterans did not perceive that they could cover the same content during phone and in-person sessionsl; materials could be more portable; BBTI created accountability; BBTI required discipline and willingness; BBTI facilitated buy-in; BBTI was aligned with military culture; loved ones could provide important support; BBTI could be improved with more personalization; BBTI challenged expectations of mental health; and BBTI improved awareness of health behaviors beyond sleep.  ,"['Insomnia (BBTI', 'veterans with insomnia disorder participating in BBTI', 'Methods:  All veterans (n=46) who were randomized to receive']",['BBTI'],['awareness of health behaviors beyond sleep'],"[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],"[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0259124,Thirteen qualitative themes were identified: BBTI provided veterans with the skills they believed they needed to continue improving independently post-treatment; beginning BBTI with in-person sessions was valued; phone sessions helped participation; veterans did not perceive that they could cover the same content during phone and in-person sessionsl; materials could be more portable; BBTI created accountability; BBTI required discipline and willingness; BBTI facilitated buy-in; BBTI was aligned with military culture; loved ones could provide important support; BBTI could be improved with more personalization; BBTI challenged expectations of mental health; and BBTI improved awareness of health behaviors beyond sleep.  ,"[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Holder', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, Mental Health, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Kanady', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, Mental Health, San Francisco, CA, USA.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Straus', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, Mental Health, San Francisco, CA, USA.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Khan', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, Mental Health, San Francisco, CA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Purcell', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, Mental Health, San Francisco, CA, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Huggins', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, Mental Health, San Francisco, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gloria', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, Mental Health, San Francisco, CA, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, Mental Health, San Francisco, CA, USA.'}, {'ForeName': 'Callan', 'Initials': 'C', 'LastName': 'Lujan', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, Mental Health, San Francisco, CA, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Maguen', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, Mental Health, San Francisco, CA, USA.'}]",Behavioral sleep medicine,['10.1080/15402002.2021.1878173']
459,33499754,Short Communication: Higher Tenofovir Concentrations in Hair Are Associated with Decreases in Viral Load and Not Self-Reported Adherence in HIV-Infected Adolescents with Second-Line Virological Treatment Failure.,"Objective methods of measuring antiretroviral adherence are limited. We assessed the relationship between tenofovir disoproxil fumarate (TDF) hair concentrations, self-reported adherence, and virological outcomes in HIV-infected adolescents in Harare, Zimbabwe. HIV-infected adolescents on atazanavir/ritonavir-based second-line treatment for >6 months with viral load (VL) ≥1,000 copies/mL were randomized to either modified directly administered antiretroviral therapy (mDAART) or standard of care. Hair and VL samples were collected at baseline and after 90 days. Treatment outcome was defined as TDF concentrations in hair. Virological suppression was defined as VL <1,000 copies/mL. Thirty-four adolescents had TDF concentrations measured at baseline and follow-up. Mean (median); range age was 16 (16); 13-18 years and 53% were females. Nineteen (56%) were randomized to mDAART. Mean (SD); range TDF concentrations were 0.03 (0.04); 0-0.17 ng/mg hair and 0.06 (0.06); 0-0.3 ng/mg hair at baseline and follow-up, respectively. Higher TDF concentrations were associated with decreased VL [regression coefficient (RC) 0.8; 95% confidence interval (CI) 0.7-1.0;  p  = .008] and mDAART (RC 0.5; 95% CI 0.3-1.0;  p  = .04), but were not associated with self-reported adherence and virological suppression (VL <1,000 copies/mL). Higher TDF hair concentrations were observed with virological decrease and an adherence intervention. Hair antiretroviral concentrations could be useful in triggering adherence interventions among adolescents with second-line virological failure.",2021,"Higher TDF concentrations were associated with decreased VL (RC 0.8; 95% CI 0.7-1.0; p=0.008) and mDAART (RC 0.5; 95% CI 0.3-1.0; p=0.04), but were not associated with self-reported adherence and virological suppression (VL <1 000 copies/ml).
","['13-18 years and 53% were females', 'Mean(median); range age was 16(16', 'for >6 months with viral load (VL) ≥1 000 copies/ml', 'adolescents with second-line virological failure', 'HIV-infected adolescents on', 'HIV-infected adolescents in Harare, Zimbabwe']","['tenofovir disoproxil fumarate (TDF', 'atazanavir/ritonavir-based second-line treatment', 'modified directly administered antiretroviral therapy (mDAART) or standard-of-care']","['adherence and virological suppression', 'Hair and VL samples', 'TDF concentrations', 'Higher TDF concentrations', 'TDF concentrations in hair', 'viral load and not self-reported adherence', 'Virological suppression', 'Higher TDF hair concentrations', 'Mean(SD); range TDF concentrations']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",,0.226458,"Higher TDF concentrations were associated with decreased VL (RC 0.8; 95% CI 0.7-1.0; p=0.008) and mDAART (RC 0.5; 95% CI 0.3-1.0; p=0.04), but were not associated with self-reported adherence and virological suppression (VL <1 000 copies/ml).
","[{'ForeName': 'Tariro', 'Initials': 'T', 'LastName': 'Chawana', 'Affiliation': 'Department of Clinical Pharmacology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Nhachi', 'Affiliation': 'Department of Clinical Pharmacology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Kusum', 'Initials': 'K', 'LastName': 'Nathoo', 'Affiliation': 'Department of Paediatrics, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ngara', 'Affiliation': 'Department of Community Medicine, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Okochi', 'Affiliation': 'Department of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Louie', 'Affiliation': 'Department of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kuncze', 'Affiliation': 'Department of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Katzenstein', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Stanford University, Stanford, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Metcalfe', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Department of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, University of California San Francisco, San Francisco, California, USA.'}]",AIDS research and human retroviruses,['10.1089/AID.2020.0258']
460,33504589,Assessment of automated clinical trial recruitment and enrolment using patient-facing technology.,"OBJECTIVE


Interactive patient care systems (IPCS) at the bedside are becoming increasingly common, but evidence is limited as to their potential for innovative clinical trial implementation. The objective of this study was to test the hypothesis that the IPCS could feasibly be used to automate recruitment and enrolment for a clinical trial.
METHODS


In medical-surgical units, we used the IPCS to randomise, recruit and consent eligible subjects. For participants not interacting with IPCS study materials within 48 hours, study staff-initiated recruitment in-person. Eligible study population included all caregivers and any patients >6 years old admitted to medical-surgical units and oncology units September 2015 to January 2016.
OUTCOMES


randomisation assessed using between-group comparisons of patient characteristics; recruitment success assessed by rates of consent; paperless implementation using successful acquisition of electronic signature and email address. We used χ 2  analysis to assess success of randomisation and recruitment.
RESULTS


Randomisation was successful (n=1012 randomised, p>0.05 for all between-group comparisons). For the subset of eligible, randomised patients who were recruited, IPCS-only recruitment (consented: 2.4% of n=213) was less successful than in-person recruitment (61.4% of n=87 eligible recruited, p<0.001). For those consenting (n=61), 96.7% provided an electronic signature and 68.9% provided email addresses.
CONCLUSIONS


Our results suggest that as a tool at the bedside, the IPCS offers key efficiencies for study implementation, including randomisation and collecting e-consent and contact information, but does not offer recruitment efficiencies. Further research could assess the value that interactive technologies bring to recruitment when paired with in-person efforts, potentially focusing on more intensive user-interface testing for recruitment materials.
TRIAL REGISTRATION NUMBER


NCT02491190.",2021,"RESULTS


Randomisation was successful (n=1012 randomised, p>0.05 for all between-group comparisons).","['For participants not interacting with IPCS study materials within 48 hours, study staff-initiated recruitment in-person', 'patients who were recruited, IPCS-only recruitment (consented: 2.4% of n=213) was less successful than in-person recruitment (61.4% of n=87 eligible recruited, p<0.001', 'Eligible study population included all caregivers and any patients >6 years old admitted to medical-surgical units and oncology units September 2015 to January 2016']",[],['patient characteristics; recruitment success assessed by rates of consent; paperless implementation using successful acquisition of electronic signature and email address'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}]",87.0,0.365537,"RESULTS


Randomisation was successful (n=1012 randomised, p>0.05 for all between-group comparisons).","[{'ForeName': 'Naomi S', 'Initials': 'NS', 'LastName': 'Bardach', 'Affiliation': 'Pediatrics, University of California San Francisco, San Francisco, California, USA naomi.bardach@ucsf.edu.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Lam', 'Affiliation': 'School of Medicine, Mayo Clinic School of Medicine, Rochester, Minnesota, USA.'}, {'ForeName': 'Carolyn B', 'Initials': 'CB', 'LastName': 'Jasik', 'Affiliation': 'Research Unit, Omada Health, San Francisco, California, USA.'}]",BMJ health & care informatics,['10.1136/bmjhci-2019-100076']
461,33513313,"Pembrolizumab Plus Ipilimumab or Placebo for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study.","PURPOSE


Pembrolizumab monotherapy is standard first-line therapy for metastatic non-small-cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1) tumor proportion score (TPS) ≥ 50% without actionable driver mutations. It is not known whether adding ipilimumab to pembrolizumab improves efficacy over pembrolizumab alone in this population.
METHODS


In the randomized, double-blind, phase III KEYNOTE-598 trial (ClinicalTrials.gov identifier: NCT03302234), eligible patients with previously untreated metastatic NSCLC with PD-L1 TPS ≥ 50% and no sensitizing  EGFR  or  ALK  aberrations were randomly allocated 1:1 to ipilimumab 1 mg/kg or placebo every 6 weeks for up to 18 doses; all participants received pembrolizumab 200 mg every 3 weeks for up to 35 doses. Primary end points were overall survival and progression-free survival.
RESULTS


Of the 568 participants, 284 were randomly allocated to each group. Median overall survival was 21.4 months for pembrolizumab-ipilimumab versus 21.9 months for pembrolizumab-placebo (hazard ratio, 1.08; 95% CI, 0.85 to 1.37;  P  = .74). Median progression-free survival was 8.2 months for pembrolizumab-ipilimumab versus 8.4 months for pembrolizumab-placebo (hazard ratio, 1.06; 95% CI, 0.86 to 1.30;  P  = .72). Grade 3-5 adverse events occurred in 62.4% of pembrolizumab-ipilimumab recipients versus 50.2% of pembrolizumab-placebo recipients and led to death in 13.1% versus 7.5%. The external data and safety monitoring committee recommended that the study be stopped for futility and that participants discontinue ipilimumab and placebo.
CONCLUSION


Adding ipilimumab to pembrolizumab does not improve efficacy and is associated with greater toxicity than pembrolizumab monotherapy as first-line treatment for metastatic NSCLC with PD-L1 TPS ≥ 50% and no targetable  EGFR  or  ALK  aberrations. These data do not support use of pembrolizumab-ipilimumab in place of pembrolizumab monotherapy in this population.",2021,"Median progression-free survival was 8.2 months for pembrolizumab-ipilimumab versus 8.4 months for pembrolizumab-placebo (hazard ratio, 1.06; 95% CI, 0.86 to 1.30;  P  = .72).","['Metastatic Non-Small-Cell Lung Cancer', '568 participants', 'eligible patients with previously untreated metastatic NSCLC with PD-L1 TPS ≥ 50% and no sensitizing  EGFR  or  ALK  aberrations']","['pembrolizumab-ipilimumab', 'Pembrolizumab monotherapy', 'pembrolizumab', 'pembrolizumab-placebo', 'Pembrolizumab Plus Ipilimumab or Placebo', 'ipilimumab 1 mg/kg or placebo']","['toxicity', 'overall survival and progression-free survival', 'Median overall survival', 'death', 'Grade 3-5 adverse events', 'Median progression-free survival']","[{'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",568.0,0.733619,"Median progression-free survival was 8.2 months for pembrolizumab-ipilimumab versus 8.4 months for pembrolizumab-placebo (hazard ratio, 1.06; 95% CI, 0.86 to 1.30;  P  = .72).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boyer', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Mehmet A N', 'Initials': 'MAN', 'LastName': 'Şendur', 'Affiliation': 'Ankara Yıldırım Beyazıt University, Faculty of Medicine and Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodríguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dae Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Çiçin', 'Affiliation': 'Trakya University, Erdine, Turkey.'}, {'ForeName': 'Perran Fulden', 'Initials': 'PF', 'LastName': 'Yumuk', 'Affiliation': 'Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Orlandi', 'Affiliation': 'Orlandi-Oncología, Providencia, Chile.'}, {'ForeName': 'Ticiana A', 'Initials': 'TA', 'LastName': 'Leal', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, WI.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Hospital of Le Mans, Le Mans, France.'}, {'ForeName': 'Nopadol', 'Initials': 'N', 'LastName': 'Soparattanapaisarn', 'Affiliation': 'Mahidol University, Sriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Langleben', 'Affiliation': ""St Mary's Hospital - ODIM, McGill University Department of Oncology, Montreal, QC, Canada.""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Califano', 'Affiliation': 'The Christie NHS Foundation Trust, and Division of Cancer Sciences, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Medgyasszay', 'Affiliation': 'Veszprém Megyei Tüdőgyógyintézet Farkasgyepű, Farkasgyepű, Hungary.'}, {'ForeName': 'Te-Chun', 'Initials': 'TC', 'LastName': 'Hsia', 'Affiliation': 'China Medical University and China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Otterson', 'Affiliation': 'The Ohio State University-James Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Samkari', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.03579']
462,33821928,Minimal-Contact Versus Standard Cognitive Behavioral Therapy for Irritable Bowel Syndrome: Cost-Effectiveness Results of a Multisite Trial.,"BACKGROUND


Irritable bowel syndrome (IBS) is a common, often disabling gastrointestinal (GI) disorder for which there is no satisfactory medical treatment but is responsive to cognitive behavior therapy (CBT).
PURPOSE


To evaluate the costs and cost-effectiveness of a minimal contact version of CBT (MC-CBT) condition for N = 145 for IBS relative to a standard, clinic-based CBT (S-CBT; N = 146) and a nonspecific comparator emphasizing education/support (EDU; N = 145).
METHOD


We estimated the per-patient cost of each treatment condition using an activity-based costing approach that allowed us to identify and estimate costs for specific components of each intervention as well as the overall total costs. Using simple means analysis and multiple regression models, we estimated the incremental effectiveness of MC-CBT relative to S-CBT and EDU. We then evaluated the cost-effectiveness of MC-CBT relative to these alternatives for selected outcomes at immediate posttreatment and 6 months posttreatment, using both an intent-to-treatment and per-protocol methodology. Key outcomes included scores on the Clinical Global Impressions-Improvement Scale and the percentage of patients who positively responded to treatment.
RESULTS


The average per-patient cost of delivering MC-CBT was $348, which was significantly less than the cost of S-CBT ($644) and EDU ($457) (p < .01). Furthermore, MC-CBT produced better average patient outcomes at immediate and 6 months posttreatment relative to S-CBT and EDU (p < .01). The current findings indicated that MC-CBT is a cost-effective option relative to S-CBT and EDU.
CONCLUSION


As predicted, MC-CBT was delivered at a lower cost per patient than S-CBT and performed better over time on the primary outcome of global IBS symptom improvement.",2021,"Furthermore, MC-CBT produced better average patient outcomes at immediate and 6 months posttreatment relative to S-CBT and EDU (p < .01).","['N = 145 for IBS relative to a standard, clinic-based CBT (S-CBT; N = 146) and a nonspecific comparator emphasizing education/support (EDU; N = 145']","['MC-CBT', 'Minimal-Contact Versus Standard Cognitive Behavioral Therapy', 'minimal contact version of CBT (MC-CBT']","['scores on the Clinical Global Impressions-Improvement Scale and the percentage of patients who positively responded to treatment', 'average per-patient cost of delivering MC-CBT', 'costs and cost-effectiveness', 'global IBS symptom improvement']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",145.0,0.0376175,"Furthermore, MC-CBT produced better average patient outcomes at immediate and 6 months posttreatment relative to S-CBT and EDU (p < .01).","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Dunlap', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jaccard', 'Affiliation': 'Silver School of Social Work, New York University, 1 Washington Square North New York, New York, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Lackner', 'Affiliation': 'Division of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, SUNY, ECMC, Buffalo, NY, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa119']
463,33533735,Crossover patterns under meiotic chromosome program.,"Repairing DNA double-strand breaks (DSBs) with homologous chromosomes as templates is the hallmark of meiosis. The critical outcome of meiotic homologous recombination is crossovers, which ensure faithful chromosome segregation and promote genetic diversity of progenies. Crossover patterns are tightly controlled and exhibit three characteristics: obligatory crossover, crossover interference, and crossover homeostasis. Aberrant crossover patterns are the leading cause of infertility, miscarriage, and congenital disease. Crossover recombination occurs in the context of meiotic chromosomes, and it is tightly integrated with and regulated by meiotic chromosome structure both locally and globally. Meiotic chromosomes are organized in a loop-axis architecture. Diverse evidence shows that chromosome axis length determines crossover frequency. Interestingly, short chromosomes show different crossover patterns compared to long chromosomes. A high frequency of human embryos are aneuploid, primarily derived from female meiosis errors. Dramatically increased aneuploidy in older women is the well-known ""maternal age effect."" However, a high frequency of aneuploidy also occurs in young women, derived from crossover maturation inefficiency in human females. In addition, frequency of human aneuploidy also shows other age-dependent alterations. Here, current advances in the understanding of these issues are reviewed, regulation of crossover patterns by meiotic chromosomes are discussed, and issues that remain to be investigated are suggested.",2021,"The critical outcome of meiotic homologous recombination is crossovers, which ensure faithful chromosome segregation and promote genetic diversity of progenies.","['young women', 'older women']",['Repairing DNA double-strand breaks (DSBs'],"['aneuploidy', 'frequency of human aneuploidy']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1511667', 'cui_str': 'Double-Strand DNA Breaks'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0301647', 'cui_str': 'Strand breaks'}]","[{'cui': 'C0002938', 'cui_str': 'Aneuploidy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]",,0.025457,"The critical outcome of meiotic homologous recombination is crossovers, which ensure faithful chromosome segregation and promote genetic diversity of progenies.","[{'ForeName': 'Shunxin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Shang', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Yanlei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Binyuan', 'Initials': 'B', 'LastName': 'Zhai', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Liangran', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.'}]",Asian journal of andrology,['10.4103/aja.aja_86_20']
464,33514270,Does rTMS Targeting Contralesional S1 Enhance Upper Limb Somatosensory Function in Chronic Stroke? A Proof-of-Principle Study.,"BACKGROUND


Somatosensory deficits are prevalent after stroke, but effective interventions are limited. Brain stimulation of the contralesional primary somatosensory cortex (S1) is a promising adjunct to peripherally administered rehabilitation therapies.
OBJECTIVE


To assess short-term effects of repetitive transcranial magnetic stimulation (rTMS) targeting contralesional (S1) of the upper extremity.
METHODS


Using a single-session randomized crossover design, stroke survivors with upper extremity somatosensory loss participated in 3 rTMS treatments targeting contralesional S1: Sham, 5 Hz, and 1 Hz. rTMS was delivered concurrently with peripheral of sensory electrical stimulation and vibration of the affected hand. Outcomes included 2-point discrimination (2PD), proprioception, vibration perception threshold, monofilament threshold (size), and somatosensory evoked potential (SEP). Measures were collected before, immediately after treatment, and 1 hour after treatment. Mixed models were fit to analyze the effects of the 3 interventions.
RESULTS


Subjects were 59.8 ± 8.1 years old and 45 ± 39 months poststroke. There was improvement in 2PD after 5-Hz rTMS for the stroke-affected ( F (2, 76.163) = 3.5,  P  = .035) and unaffected arm ( F (2, 192.786) = 10.6,  P  < .0001). Peak-to-peak SEP amplitudes were greater after 5-Hz rTMS for N33-P45 ( F (2, 133.027) = 3.518,  P  = .032) and N45-P60 ( F (2, 67.353) = 3.212,  P  = .047). Latencies shortened after 5-Hz rTMS for N20 ( F (2, 69.64) = 3.37,  P  = .04), N60 ( F (2, 47.343) = 4.375,  P  = .018), and P100 ( F (2, 37.608) = 3.537,  P  = .039) peaks. There were no differences between changes immediately after the intervention and an hour later.
CONCLUSIONS


Short-term application of facilitatory high-frequency rTMS (5Hz) to contralesional S1 combined with peripheral somatosensory stimulation may promote somatosensory function. This intervention may serve as a useful adjunct in somatosensory rehabilitation after stroke.",2021,Peak-to-peak SEP amplitudes were greater after 5-Hz rTMS for N33-P45,"['Subjects were 59.8 ± 8.1 years old and 45 ± 39 months poststroke', 'stroke survivors with upper extremity somatosensory loss participated in 3']","['rTMS treatments targeting contralesional S1: Sham, 5 Hz, and 1 Hz', '5-Hz rTMS', 'contralesional primary somatosensory cortex (S1', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '5-Hz rTMS for N33-P45']","['Peak-to-peak SEP amplitudes', '2PD', '2-point discrimination (2PD), proprioception, vibration perception threshold, monofilament threshold (size), and somatosensory evoked potential (SEP']","[{'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3496281', 'cui_str': 'Primary Somatic Sensory Area'}, {'cui': 'C1334860', 'cui_str': 'N33 protein, human'}, {'cui': 'C0381943', 'cui_str': 'Skp2 Protein'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C0429277', 'cui_str': 'Two point static discrimination response'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.057305,Peak-to-peak SEP amplitudes were greater after 5-Hz rTMS for N33-P45,"[{'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Pundik', 'Affiliation': 'Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Skelly', 'Affiliation': 'Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McCabe', 'Affiliation': 'Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Akbari', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Tatsuoka', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Ela B', 'Initials': 'EB', 'LastName': 'Plow', 'Affiliation': 'Lerner College of Medicine, Cleveland Clinic, Cleveland, OH, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968321989338']
465,33523106,Effect of Enteral Lipid Supplement on Severe Retinopathy of Prematurity: A Randomized Clinical Trial.,"Importance


Lack of arachidonic acid (AA) and docosahexaenoic acid (DHA) after extremely preterm birth may contribute to preterm morbidity, including retinopathy of prematurity (ROP).
Objective


To determine whether enteral supplementation with fatty acids from birth to 40 weeks' postmenstrual age reduces ROP in extremely preterm infants.
Design, Setting, and Participants


The Mega Donna Mega trial, a randomized clinical trial, was a multicenter study performed at 3 university hospitals in Sweden from December 15, 2016, to December 15, 2019. The screening pediatric ophthalmologists were masked to patient groupings. A total of 209 infants born at less than 28 weeks' gestation were tested for eligibility, and 206 infants were included. Efficacy analyses were performed on as-randomized groups on the intention-to-treat population and on the per-protocol population using as-treated groups. Statistical analyses were performed from February to April 2020.
Interventions


Infants received either supplementation with an enteral oil providing AA (100 mg/kg/d) and DHA (50 mg/kg/d) (AA:DHA group) or no supplementation within 3 days after birth until 40 weeks' postmenstrual age.
Main Outcomes and Measures


The primary outcome was severe ROP (stage 3 and/or type 1). The secondary outcomes were AA and DHA serum levels and rates of other complications of preterm birth.
Results


A total of 101 infants (58 boys [57.4%]; mean [SD] gestational age, 25.5 [1.5] weeks) were included in the AA:DHA group, and 105 infants (59 boys [56.2%]; mean [SD] gestational age, 25.5 [1.4] weeks) were included in the control group. Treatment with AA and DHA reduced severe ROP compared with the standard of care (16 of 101 [15.8%] in the AA:DHA group vs 35 of 105 [33.3%] in the control group; adjusted relative risk, 0.50 [95% CI, 0.28-0.91]; P = .02). The AA:DHA group had significantly higher fractions of AA and DHA in serum phospholipids compared with controls (overall mean difference in AA:DHA group, 0.82 mol% [95% CI, 0.46-1.18 mol%]; P < .001; overall mean difference in control group, 0.13 mol% [95% CI, 0.01-0.24 mol%]; P = .03). There were no significant differences between the AA:DHA group and the control group in the rates of bronchopulmonary dysplasia (48 of 101 [47.5%] vs 48 of 105 [45.7%]) and of any grade of intraventricular hemorrhage (43 of 101 [42.6%] vs 42 of 105 [40.0%]). In the AA:DHA group and control group, respectively, sepsis occurred in 42 of 101 infants (41.6%) and 53 of 105 infants (50.5%), serious adverse events occurred in 26 of 101 infants (25.7%) and 26 of 105 infants (24.8%), and 16 of 101 infants (15.8%) and 13 of 106 infants (12.3%) died.
Conclusions and Relevance


This study found that, compared with standard of care, enteral AA:DHA supplementation lowered the risk of severe ROP by 50% and showed overall higher serum levels of both AA and DHA. Enteral lipid supplementation with AA:DHA is a novel preventive strategy to decrease severe ROP in extremely preterm infants.
Trial Registration


ClinicalTrials.gov Identifier: NCT03201588.",2021,There were no significant differences between the AA:DHA group and the control group in the rates of bronchopulmonary dysplasia (48 of 101 [47.5%] vs 48 of 105 [45.7%]) and of any grade of intraventricular hemorrhage (43 of 101 [42.6%] vs 42 of 105 [40.0%]).,"[""209 infants born at less than 27 weeks' gestation were tested for eligibility, and 206 infants were included"", 'Severe Retinopathy of Prematurity', 'A total of 101 infants (58 boys [57.4%]; mean [SD] gestational age, 25.5 [1.5] weeks) were included in the AA:DHA group, and 105 infants (59 boys [56.2%]; mean [SD] gestational age, 25.5 [1.4] weeks) were included in the control group', 'multicenter study performed at 3 university hospitals in Sweden from December 15, 2016, to December 15, 2019', 'extremely preterm infants']","['DHA', 'no supplementation', 'arachidonic acid (AA) and docosahexaenoic acid (DHA', 'supplementation with an enteral oil providing AA', 'Enteral lipid supplementation with AA', 'enteral supplementation with fatty acids', 'Enteral Lipid Supplement']","['intraventricular hemorrhage', 'sepsis', 'serious adverse events', 'AA and DHA serum levels and rates of other complications of preterm birth', 'rates of bronchopulmonary dysplasia', 'severe ROP', 'fractions of AA and DHA in serum phospholipids', 'risk of severe ROP']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",209.0,0.569541,There were no significant differences between the AA:DHA group and the control group in the rates of bronchopulmonary dysplasia (48 of 101 [47.5%] vs 48 of 105 [45.7%]) and of any grade of intraventricular hemorrhage (43 of 101 [42.6%] vs 42 of 105 [40.0%]).,"[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hellström', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anders K', 'Initials': 'AK', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Wackernagel', 'Affiliation': ""Department of Neonatology, Karolinska University Hospital and Institute, Astrid Lindgrens Children's Hospital, Stockholm, Sweden.""}, {'ForeName': 'Aldina', 'Initials': 'A', 'LastName': 'Pivodic', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Vanpee', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet and Karolinska Univeristy Hospital, Stockholm, Sweden.""}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Sjöbom', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Gunnel', 'Initials': 'G', 'LastName': 'Hellgren', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Boubou', 'Initials': 'B', 'LastName': 'Hallberg', 'Affiliation': 'Department of Pediatrics, Institution of Clinical Science Intervention and Technology (CLINTEC), Karolinska Institutet and Department of Neonatology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Domellöf', 'Affiliation': 'Institute of Cinical Science, Department of Pediatrics, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Klevebro', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hellström', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, Department of Pediatrics, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anna-My', 'Initials': 'AM', 'LastName': 'Lund', 'Affiliation': ""Region Västra Götaland, Department of Neonatology, The Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.""}, {'ForeName': 'Chatarina', 'Initials': 'C', 'LastName': 'Löfqvist', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Elfvin', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, Department of Pediatrics, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Sävman', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, Department of Pediatrics, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Hansen-Pupp', 'Affiliation': 'Department of Pediatrics, Institute of Clinical Sciences Lund, Lund University and Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Hård', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lois E H', 'Initials': 'LEH', 'LastName': 'Smith', 'Affiliation': ""Department of Ophthalmology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ley', 'Affiliation': 'Department of Pediatrics, Institute of Clinical Sciences Lund, Lund University and Skane University Hospital, Lund, Sweden.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.5653']
466,33528113,Pharmacokinetics and Safety of Dapoxetine Hydrochloride in Healthy Chinese Men: Impact of Dose and High-Fat Meal.,"Dapoxetine is the first oral medication specifically developed for the on-demand treatment of premature ejaculation. The pharmacokinetics and safety of 30 mg (n = 40) and 60 mg (n = 38) dapoxetine in healthy Chinese under fasted and fed states were assessed in 2 studies. Both studies are random, single-center, 2-period, open-label, 2-way crossover designs. Plasma concentration of dapoxetine was determined by high-performance liquid chromatography-tandem mass spectrometry, and the pharmacokinetic parameters were calculated using noncompartmental analysis. Dapoxetine was quickly absorbed and reached maximum concentration 1 to 3 hours after oral administration. Elimination was biphasic, and the plasma concentration decreased to 3% to 7% of maximum concentration by 24 hours while half-life was 15 to 18 hours. Meantime, high-fat meals slightly increased its exposure. Both doses of dapoxetine were well tolerated. The adverse events in the high-dose group under fasted and fed states were 37.9% and 19.0%, respectively.",2021,The pharmacokinetics and safety of 30 mg (n = 40) and 60 mg (n = 38) dapoxetine in healthy Chinese under fasted and fed states were assessed in 2 studies.,"['healthy Chinese under fasted and fed states were assessed in 2 studies', 'Healthy Chinese Men']","['Dapoxetine Hydrochloride', 'dapoxetine', 'Dapoxetine']","['tolerated', 'plasma concentration', 'Plasma concentration of dapoxetine', 'adverse events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0970823', 'cui_str': 'Dapoxetine hydrochloride'}, {'cui': 'C0215087', 'cui_str': 'dapoxetine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0215087', 'cui_str': 'dapoxetine'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0334575,The pharmacokinetics and safety of 30 mg (n = 40) and 60 mg (n = 38) dapoxetine in healthy Chinese under fasted and fed states were assessed in 2 studies.,"[{'ForeName': 'Jingyan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'School of Pharmacy Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'School of Pharmacy Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Keyu', 'Initials': 'K', 'LastName': 'Yan', 'Affiliation': 'School of Pharmacy Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Gehang', 'Initials': 'G', 'LastName': 'Ju', 'Affiliation': 'School of Pharmacy Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': 'School of Pharmacy Lanzhou University, Lanzhou, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.919']
467,33538091,Modification of the effects of intensive systolic blood pressure control on kidney outcomes by baseline body mass index.,"AIM


Obesity and intensive systolic blood pressure (SBP) control are independently associated with greater risk of acute kidney injury (AKI) and incident chronic kidney disease (CKD). We examined whether baseline body mass index (BMI) modifies the effects of intensive SBP lowering on AKI or incident CKD.
METHODS


The systolic blood pressure intervention trial (SPRINT) randomized 9361 participants with high blood pressure to an SBP target of either <120 mm Hg or < 140 mm Hg. In a secondary analysis of 9210 SPRINT participants with a baseline BMI of ≥18.5 and < 50 kg/m 2  , we examined the interactions of baseline BMI and SPRINT SBP intervention on subsequent AKI and incident CKD.
RESULTS


Each 5 kg/m 2  increase in baseline BMI was associated with higher risk of AKI (hazard ratio [HR] 1.12, 95% confidence interval [CI] 1.01 to 1.25) and incident CKD (HR 1.17, 95% CI 1.01 to 1.32). Intensive SBP control increased the risk of AKI (HR 1.68, 95% CI 1.22-2.11) and incident CKD (HR 3.49, 95% CI 2.47-4.94). The increased risk of AKI with intensive SBP control was consistent across the baseline BMI spectrum (linear interaction p = 0.55); however, the risk of incident CKD with SPRINT intervention increased with higher BMI (linear interaction p = 0.043).
CONCLUSION


The increased risk of adverse kidney events seen with intensive SBP control in the SPRINT persisted across the baseline BMI spectrum. A higher baseline BMI was associated with an augmented risk of incident CKD with intensive SBP control.",2021,"Intensive SBP control increased the risk of AKI (HR 1.68, 95% CI 1.22 to 2.11) and incident CKD (HR 3.49, 95% CI 2.47 to 4.94).","['9361 participants with high blood pressure to a SBP target of either <\u2009120\u2009mm Hg or <\u2009140\u2009mm Hg', '9210 SPRINT participants with a baseline BMI of ≥18.5 and <\u200950 Kg/m 2']","['SPRINT SBP intervention', 'intensive systolic blood pressure (SBP) control', 'Intensive Systolic Blood Pressure Control']","['incident CKD', 'risk of AKI (hazard ratio [HR', 'baseline BMI', 'risk of AKI', 'risk of AKI with intensive SBP control']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",9361.0,0.0708047,"Intensive SBP control increased the risk of AKI (HR 1.68, 95% CI 1.22 to 2.11) and incident CKD (HR 3.49, 95% CI 2.47 to 4.94).","[{'ForeName': 'Adhish', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Boucher', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Faris', 'Initials': 'F', 'LastName': 'Ahmed', 'Affiliation': 'Division of Nephrology, University of Alabama, Birmingham, Alabama, USA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}]","Nephrology (Carlton, Vic.)",['10.1111/nep.13857']
468,33535224,Cortisol and Cortisone in Early Childhood in Very-Low-Birthweight Infants and Term-Born Infants.,"INTRODUCTION


Besides programming of the hypothalamic-pituitary-adrenal (HPA) axis, changes in the activity of 11β-hydroxysteroid dehydrogenase type 2 (11β-HSD2) could contribute to the later metabolic and cardiovascular consequences of preterm birth.
OBJECTIVE


We compared serum cortisol, cortisone, and cortisol/cortisone ratio in early childhood in very-low-birthweight (VLBW) infants and term appropriate for gestational age (AGA) born infants.
METHODS


We included 41 VLBW infants, participating in the randomized controlled Neonatal Insulin Replacement Therapy in Europe trial, and 64 term AGA-born infants. Cortisol and cortisone were measured in blood samples taken at 6 months and 2 years corrected age (VLBW children) and at 3 months and 1 and 2 years (term children). At 2 years of (corrected) age (HDL) cholesterol, triglycerides, glucose, and insulin were also measured.
RESULTS


During the first 2 years of life, cortisol/cortisone ratio is higher in VLBW children compared to term children. In the total group of children, cortisol/cortisone ratio is positively related to triglycerides at 2 years of (corrected) age. In VLBW children, over the first 2 years of life both cortisol and cortisone are higher in the early-insulin group compared to the standard care group.
CONCLUSIONS


In VLBW infants, lower 11β-HSD2 activity probably contributes to the long-term metabolic and cardiovascular risks. In VLBW infants, early insulin treatment could affect programming of the HPA axis, resulting in higher cortisol and cortisone levels during early childhood.",2020,"During the first 2 years of life, cortisol/cortisone ratio is higher in VLBW children compared to term children.","['Early Childhood in Very-Low-Birthweight Infants and Term-Born Infants', 'early childhood in very-low-birthweight (VLBW) infants and term appropriate for gestational age (AGA) born infants', '41 VLBW infants, participating in the randomized controlled Neonatal Insulin Replacement Therapy in Europe trial, and 64 term AGA-born infants']","['serum cortisol, cortisone, and cortisol/cortisone ratio', 'Cortisol and Cortisone']","['life, cortisol/cortisone ratio', '11β-HSD2 activity', 'Cortisol and cortisone', 'corrected) age (HDL) cholesterol, triglycerides, glucose, and insulin', 'higher cortisol and cortisone levels', 'cortisol/cortisone ratio']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0541847', 'cui_str': 'Cortisol increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",41.0,0.024566,"During the first 2 years of life, cortisol/cortisone ratio is higher in VLBW children compared to term children.","[{'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'de Jong', 'Affiliation': 'Department of Pediatrics, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Cranendonk', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.""}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Mirjam M', 'Initials': 'MM', 'LastName': 'van Weissenbruch', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands, m.vanweissenbruch@amsterdamumc.nl.""}]",Hormone research in paediatrics,['10.1159/000512784']
469,33545170,Atropine for the Treatment of Childhood Myopia in India: Multicentric Randomized Trial.,,2021,"This multicentric, double-blinded, placebo-controlled randomized clinical trial reports 1-year-data proving efficacy of 0.01% atropine drops in reducing myopia progression (spherical equivalent) in Indian children having mild to moderate myopia without any significant effect on axial length elongation.","['childhood myopia in India', 'Indian children having mild to moderate myopia']","['Atropine', 'atropine', 'placebo']","['axial length elongation', 'myopia progression (spherical equivalent']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",,0.730372,"This multicentric, double-blinded, placebo-controlled randomized clinical trial reports 1-year-data proving efficacy of 0.01% atropine drops in reducing myopia progression (spherical equivalent) in Indian children having mild to moderate myopia without any significant effect on axial length elongation.","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Saxena', 'Affiliation': 'Pediatric Ophthalmology and Strabismus Services, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi, India. Electronic address: rohitsaxena80@yahoo.com.'}, {'ForeName': 'Rebika', 'Initials': 'R', 'LastName': 'Dhiman', 'Affiliation': 'Pediatric Ophthalmology and Strabismus Services, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi, India.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Pediatric Ophthalmology and Strabismus Services, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi, India.'}, {'ForeName': 'Pawan', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Pediatric Ophthalmology and Strabismus Services, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Matalia', 'Affiliation': 'Department of Pediatric Ophthalmology, Strabismus and Neuro-ophthalmology, Narayana Nethralaya, Bangalore, India.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Roy', 'Affiliation': 'Pediatric Ophthalmology and Medical Retina, Centre for Vision and Eye Surgery, OMR, Chennai, India.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Swaminathan', 'Affiliation': 'Department of Pediatric Ophthalmology, Medical Research Foundation, Sankara Nethralaya, Chennai, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Phuljhele', 'Affiliation': 'Pediatric Ophthalmology and Strabismus Services, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Velpandian', 'Affiliation': 'Department of Pharmacology, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Pediatric Ophthalmology and Strabismus Services, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi, India.'}]",Ophthalmology,['10.1016/j.ophtha.2021.01.026']
470,33531563,Randomized controlled trial comparing the effectiveness of mass and spaced learning in microsurgical procedures using computer aided assessment.,"Spaced-learning refers to teaching spread over time, compared to mass-learning where the same duration of teaching is completed in one session. Our hypothesis is that spaced-learning is better than mass-learning in retaining microsurgical suturing skills. Medical students were randomized into mass-learning (single 8-h session) and spaced-learning (2-h weekly sessions over 4 weeks) groups. They were taught to place 9 sutures in a 4 mm-wide elastic strip. The primary outcome was precision of suture placement during a test conducted 1 month after completion of sessions. Secondary outcomes were time taken, cumulative performance, and participant satisfaction. 42 students (24 in the mass-learning group; 18 in spaced-learning group) participated. 3 students in the spaced-learning group were later excluded as they did not complete all sessions. Both groups had comparable baseline suturing skills but at 1 month after completion of teaching, the total score for suture placement were higher in spaced-learning group (27.63 vs 31.60,p = 0.04). There was no statistical difference for duration and satisfaction in either group. Both groups showed an improvement in technical performance over the sessions, but this did not differ between both groups. Microsurgical courses are often conducted in mass-learning format so spaced learning offers an alternative that enhances retention of complex surgical skills.",2021,"Both groups had comparable baseline suturing skills but at 1 month after completion of teaching, the total score for suture placement were higher in spaced-learning group (27.63 vs 31.60,p = 0.04).","['42 students (24 in the mass-learning group; 18 in spaced-learning group) participated', 'Medical students']",['mass and spaced learning'],"['technical performance', 'total score for suture placement', 'duration and satisfaction', 'time taken, cumulative performance, and participant satisfaction', 'baseline suturing skills', 'precision of suture placement']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",42.0,0.0523513,"Both groups had comparable baseline suturing skills but at 1 month after completion of teaching, the total score for suture placement were higher in spaced-learning group (27.63 vs 31.60,p = 0.04).","[{'ForeName': 'Wendy Z W', 'Initials': 'WZW', 'LastName': 'Teo', 'Affiliation': 'Department of Hand and Reconstructive Microsurgery, National University Health System, 1E Kent Ridge Rd, Singapore, 119228, Singapore. wendy_zw_teo@nuhs.edu.sg.'}, {'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Department of Hand and Reconstructive Microsurgery, National University Health System, 1E Kent Ridge Rd, Singapore, 119228, Singapore.'}, {'ForeName': 'Siti Khadijah Bte Mohd', 'Initials': 'SKBM', 'LastName': 'Yusoff', 'Affiliation': 'Department of Hand and Reconstructive Microsurgery, National University Health System, 1E Kent Ridge Rd, Singapore, 119228, Singapore.'}, {'ForeName': 'Soumen', 'Initials': 'S', 'LastName': 'Das De', 'Affiliation': 'Department of Hand and Reconstructive Microsurgery, National University Health System, 1E Kent Ridge Rd, Singapore, 119228, Singapore.'}, {'ForeName': 'Alphonsus K S', 'Initials': 'AKS', 'LastName': 'Chong', 'Affiliation': 'Department of Hand and Reconstructive Microsurgery, National University Health System, 1E Kent Ridge Rd, Singapore, 119228, Singapore.'}]",Scientific reports,['10.1038/s41598-021-82419-6']
471,33538248,Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease in the COMPASS Trial.,"BACKGROUND


Direct oral anticoagulants are administered in fixed doses irrespective of body weight, but guidelines recommend against their use in patients with extremes of body weight.
OBJECTIVES


This study determined the effects of dual-pathway inhibition antithrombotic regimen (rivaroxaban 2.5 mg twice daily plus aspirin 100 mg/day) compared with aspirin Halone across a range of patient body mass indexes (BMIs) and body weights.
METHODS


This was a secondary analysis of the COMPASS (Cardiovascular OutcoMes for People using Anticoagulation StrategieS) trial, which included patients with chronic coronary artery disease or peripheral artery disease. Efficacy and safety outcomes were studied in relation to BMI: (normal 18.5 ≤BMI <25 kg/m 2 , overweight 25 ≤BMI <30 kg/m 2 , obese ≥30 kg/m 2 ) and body weight (≤70 kg, 70 < weight ≤90 kg, and >90 kg; as well as ≤120 kg vs. >120 kg).
RESULTS


Among 27,395 randomized patients, 6,459 (24%) had normal BMI, 12,047 (44%) were overweight, and 8,701 (32%) were obese. The combination of rivaroxaban and aspirin compared with aspirin produced a consistent reduction in the primary outcome of cardiovascular death, stroke, or myocardial infarction, irrespective of BMI or body weight. For 18.5 ≤BMI <25 kg/m 2 : 3.5% vs. 5.0%; hazard ratio (HR): 0.73 (95% credible interval [CrI]: 0.58 to 0.90); 25 ≤ BMI <30 kg/m 2 : 4.3% vs. 5.1%; HR: 0.80 (95% CrI: 0.66 to 0.96); BMI ≥30 kg/m 2 : 4.2% vs. 6.1%; HR: 0.71 (95% CrI: 0.57 to 0.86). For body weight ≤70 kg: 4.1% vs. 5.3%; HR: 0.75 (95% CrI: 0.62 to 0.91); 70 < weight ≤90 kg: 4.1% vs. 5.3%; HR: 0.76 (95% CrI: 0.65 to 0.89); >90 kg: 4.2% vs. 5.7%; HR: 0.74 (95% CrI: 0.61 to 0.90). Effects on bleeding, mortality, and net clinical benefit were consistent irrespective of BMI or bodyweight.
CONCLUSIONS


The effects of dual-pathway antithrombotic therapy are consistent irrespective of BMI or body weight, suggesting no need for dose adjustments in the ranges of weights and BMI of patients enrolled in the COMPASS trial. Further studies need to address this problem in relation to greater extremes of body weight. (Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease [COMPASS]; NCT01776424).",2021,"The combination of rivaroxaban and aspirin compared with aspirin produced a consistent reduction in the primary outcome of cardiovascular death, stroke, or myocardial infarction, irrespective of BMI or body weight.","['For body weight\xa0≤70\xa0kg', '27,395 randomized patients, 6,459 (24%) had normal BMI, 12,047 (44%) were overweight, and 8,701 (32%) were obese', 'patients with extremes of body weight', 'patients with chronic coronary artery disease or peripheral artery disease', 'Obese and Overweight Patients With Vascular Disease in the COMPASS Trial']","['rivaroxaban and aspirin', 'aspirin Halone', 'dual-pathway antithrombotic therapy', 'dual-pathway inhibition antithrombotic regimen (rivaroxaban 2.5\xa0mg twice daily plus aspirin', 'Rivaroxaban', 'aspirin', 'Rivaroxaban Plus Aspirin']","['bleeding, mortality, and net clinical benefit', 'body weight', 'Efficacy and safety outcomes', 'cardiovascular death, stroke, or myocardial infarction, irrespective of BMI or body weight']","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4731644', 'cui_str': 'rivaroxaban 2.5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",27395.0,0.116239,"The combination of rivaroxaban and aspirin compared with aspirin produced a consistent reduction in the primary outcome of cardiovascular death, stroke, or myocardial infarction, irrespective of BMI or body weight.","[{'ForeName': 'Tomasz J', 'Initials': 'TJ', 'LastName': 'Guzik', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Research, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom; Department of Internal and Agricultural Medicine, Jagiellonian University, Collegium Medicum, Krakow, Poland. Electronic address: tomasz.guzik@glasgow.ac.uk.'}, {'ForeName': 'Chinthanie', 'Initials': 'C', 'LastName': 'Ramasundarahettige', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Masira Research Institute, Universidad de Santander (UDES), Bucaramanga, Colombia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Clinical Development, Group Head Thrombosis, Bayer U.S. LLC, Research & Development, Pharmaceuticals, Thrombosis & Hematology Therapeutic Area, Whippany, New Jersey, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muehlhofer', 'Affiliation': 'Bayer AG, Research & Development, Pharmaceuticals, Therapeutic Area Thrombosis & Vascular Medicine, Wuppertal, Germany.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.11.061']
472,33527137,The Effect of Metformin vs Placebo on Sex Hormones in Canadian Cancer Trials Group MA.32.,"BACKGROUND


Metformin has been associated with lower breast cancer (BC) risk and improved outcomes in observational studies. Multiple biologic mechanisms have been proposed, including a recent report of altered sex hormones. We evaluated the effect of metformin on sex hormones in MA.32, a phase III trial of nondiabetic BC subjects who were randomly assigned to metformin or placebo.
METHODS


We studied the subgroup of postmenopausal hormone receptor-negative BC subjects not receiving endocrine treatment who provided fasting blood at baseline and at 6 months after being randomly assigned. Sex hormone-binding globulin, bioavailable testosterone, and estradiol levels were assayed using electrochemiluminescence immunoassay. Change from baseline to 6 months between study arms was compared using Wilcoxon sum rank tests and regression models.
RESULTS


312 women were eligible (141 metformin vs 171 placebo); the majority of subjects in each arm had T1/2, N0, HER2-negative BC and had received (neo)adjuvant chemotherapy. Mean age was 58.1 (SD=6.9) vs 57.5 (SD=7.9) years, mean body mass index (BMI) was 27.3 (SD=5.5) vs 28.9 (SD=6.4) kg/m2 for metformin vs placebo, respectively. Median estradiol decreased between baseline and 6 months on metformin vs placebo (-5.7 vs 0 pmol/L; P < .001) in univariable analysis and after controlling for baseline BMI and BMI change (P < .001). There was no change in sex hormone-binding globulin or bioavailable testosterone.
CONCLUSION


Metformin lowered estradiol levels, independent of BMI. This observation suggests a new metformin effect that has potential relevance to estrogen sensitive cancers.",2021,"There was no change in sex hormone-binding globulin or bioavailable testosterone.
","['312 women were eligible (141 metformin vs 171 placebo); the majority of subjects in each arm had T1/2, N0, HER2-negative BC and had received (neo)adjuvant chemotherapy', 'subgroup of postmenopausal hormone receptor-negative BC subjects not receiving endocrine treatment who provided fasting blood at baseline and at 6\u2009months after being randomly assigned', 'Mean age was 58.1 (SD=6.9) vs 57.5 (SD=7.9)\u2009years, mean body mass index ', 'sex hormones in MA.32, a phase III trial of nondiabetic BC subjects']","['placebo', 'metformin or placebo', 'Metformin', 'metformin', 'Metformin vs Placebo', 'metformin vs placebo']","['Median estradiol', 'baseline BMI and BMI change', 'BMI', 'sex hormone-binding globulin or bioavailable testosterone', 'estradiol levels', 'Sex hormone-binding globulin, bioavailable testosterone, and estradiol levels']","[{'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0370051', 'cui_str': 'Bioavailable testosterone'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}]",312.0,0.304199,"There was no change in sex hormone-binding globulin or bioavailable testosterone.
","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Pimentel', 'Affiliation': 'Vall d`Hebron Institute of Oncology (VHIO), Barcelona, Spain.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University-Cancer Research Institute, Kingston, ON, Canada.""}, {'ForeName': 'Ana Elisa', 'Initials': 'AE', 'LastName': 'Lohmann', 'Affiliation': 'University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Ennis', 'Affiliation': 'Applied Statistician, Markham, ON, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ligibel', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Shepherd', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University-Cancer Research\u2002Institute, Kingston, ON, Canada.""}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Herbert Irving Cancer Center, Columbia University, New York, NY, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Whelan', 'Affiliation': 'Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Vuk', 'Initials': 'V', 'LastName': 'Stambolic', 'Affiliation': 'University Health Network, Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University, Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hobday', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lemieux', 'Affiliation': 'CHA-Hopital Du St-Sacrement, Hopital Enfant Jesus Site, Quebec City, Canada.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'BCCA-Vancouver Cancer Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rea', 'Affiliation': 'Institute of Cancer Research, Clinical Trials and Statistics Unit, Sutton, UK.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': 'IBCSG Coordinating Centre, Bern, Switzerland.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ellard', 'Affiliation': 'BCCA-Cancer Centre for the Southern Interior, Kelowna, BC, Canada.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston, ON, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bedard', 'Affiliation': 'University Health Network, Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Pitre', 'Affiliation': 'Health Sciences North, Sudbury, ON, Canada.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Vandenberg', 'Affiliation': 'London Regional Cancer Program, London, ON, Canada.'}, {'ForeName': 'Ryan J O', 'Initials': 'RJO', 'LastName': 'Dowling', 'Affiliation': 'University Health Network, Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Parulekar', 'Affiliation': ""Canadian Cancer Trials Group\u2002, Queen's University-Cancer Research\u2002 Institute, Kingston, ON, Canada.""}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Goodwin', 'Affiliation': 'Lunenfeld Tanenbaum Research Institute at Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa082']
473,33559851,"Citrate high volume on-line hemodiafiltration modulates serum Interleukin-6 and Klotho levels: the multicenter randomized controlled study ""Hephaestus"".","BACKGROUND


Studies addressing the anti-inflammatory properties of citrate dialysate enrolled patients in both hemodialysis (HD) and hemodiafiltration (HDF), the latter not adjusted for adequate convective exchange. This is a potential source of confounding in that HDF itself has anti-inflammatory effects regardless of the buffer, and optimal clinical outcomes are related to the amount of convection.
METHODS


To distinguish the merits of the buffer from those of convection, we performed a 6-month, prospective, randomized, crossover AB-BA study. Comparisons were made during the 3-month study period of on-line HDF with standard dialysate containing three mmol of acetic acid (OL-HDFst) and the 3-month of OL-HDF with dialysate containing one mmol of citric acid (OL-HDFcit). Primary outcome measure of the study was interleukin-6 (IL-6). Klotho, high sensitivity C-reactive protein (hsCRP), fetuin and routine biochemical parameters were also analyzed.
RESULTS


We analyzed 47 patients (mean age 64 years, range 27-84 years) enrolled in 10 participating Nephrology Units. Convective volumes were around 25 L/session with 90 percent of sessions > 20 L and ß2-microglobulin reduction rate 76% in both HDFs. Baseline median IL-6 values in OL-HDFst were 5.6 pg/ml (25:75 interquartile range IQR 2.9:10.6) and in OL-HDFcit 6.6 pg/ml (IQR 3.4:11.4 pg/ml). The difference was not statistically significant (p 0.88). IL-6 values were lower during OL-HDFcit than during OL-HDFst, both when analyzed as the median difference of overall IL-6 values (p 0.02) and as the median of pairwise differences between the baseline and the 3-month time points (p 0.03). The overall hsCRP values too, were lower during OL-HDFcit than during OL-HDFst (p 0.01). Klotho levels showed a time effect (p 0.02) and the increase was significant only during OL-HDFcit (p 0.01).
CONCLUSIONS


Citrate buffer modulated IL-6, hsCRP and Klotho levels during high volume OL-HDF. These results are not attributable to differences in the dialysis technology that was applied and may suggest a potential biological effect of citrate on CKD-associated inflammatory state. ClinicalTrials.gov identifier NCT02863016.",2021,IL-6,"['dialysis patients with low grade inflammation', 'enrolled patients in both hemodialysis (HD) and hemodiafiltration (HDF', '47 patients (mean age 64\xa0years, range 27-84\xa0years) enrolled in 10 participating Nephrology Units']","['standard dialysate containing three mmol of acetic acid (OL-HDFst', 'IL-6', 'OL-HDF with dialysate containing one mmol of citric acid (OL-HDFcit', 'citrate dialysate']","['overall hsCRP values', 'IL-6, hsCRP and Klotho levels', 'interleukin-6 (IL-6', 'Baseline median IL-6 values in OL-HDFst', 'Klotho, high sensitivity C-reactive protein (hsCRP), fetuin and routine biochemical parameters', 'Convective volumes', 'overall IL-6 values']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0508655,IL-6,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pizzarelli', 'Affiliation': ""Nephrology and Dialysis Unit, SM Annunziata Hospital, ASL Toscana Centro, via dell'Antella, 50012, Firenze, Italy. fpizzarelli@yahoo.com.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Cantaluppi', 'Affiliation': 'Nephrology and Kidney Transplantation Unit, Department of Translational Medicine, University of Piemonte Orientale (UPO), Novara, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Panichi', 'Affiliation': 'Nephrology and Dialysis Unit, Versilia Hospital, ASL Nord-Ovest, Lido Di Camaiore, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Toccafondi', 'Affiliation': ""Nephrology and Dialysis Unit, SM Annunziata Hospital, ASL Toscana Centro, via dell'Antella, 50012, Firenze, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Ferro', 'Affiliation': ""Nephrology and Dialysis Unit, SM Annunziata Hospital, ASL Toscana Centro, via dell'Antella, 50012, Firenze, Italy.""}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Farruggio', 'Affiliation': 'Nephrology and Kidney Transplantation Unit, Department of Translational Medicine, University of Piemonte Orientale (UPO), Novara, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Grossini', 'Affiliation': 'Lab Physiology, Department Translational Medicine, University of Piemonte Orientale (UPO), Novara, Italy.'}, {'ForeName': 'Pietro Claudio', 'Initials': 'PC', 'LastName': 'Dattolo', 'Affiliation': ""Nephrology and Dialysis Unit, SM Annunziata Hospital, ASL Toscana Centro, via dell'Antella, 50012, Firenze, Italy.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Miniello', 'Affiliation': 'Nephrology and Dialysis Unit, ASL Toscana Centro, Pistoia, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Migliori', 'Affiliation': 'Nephrology and Dialysis Unit, Versilia Hospital, ASL Nord-Ovest, Lido Di Camaiore, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Grimaldi', 'Affiliation': 'Nephrology and Dialysis Unit, NSGD Hospital, ASL Toscana Centro, Firenze, Italy.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Casani', 'Affiliation': 'Nephrology and Dialysis Unit, ASL Nord-Ovest, Massa Carrara, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Borzumati', 'Affiliation': 'Nephrology and Dialysis Unit, ASL VCO, Verbania, Verbano Cusio Ossola, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cusinato', 'Affiliation': 'Nephrology and Dialysis Unit, Borgomanero Hospital, ASL NO Novara, Borgomanero, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Capitanini', 'Affiliation': 'Nephrology and Dialysis Unit, ASL Toscana Centro, Pistoia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Quercia', 'Affiliation': 'Nephrology and Dialysis Unit, ASL Biella, Biella, Italy.'}, {'ForeName': 'Oliviero', 'Initials': 'O', 'LastName': 'Filiberti', 'Affiliation': 'Nephrology and Dialysis Unit, ASL Vercelli, Vercelli, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Dani', 'Affiliation': 'Nephrology and Dialysis Unit, ASL Toscana Centro, Empoli, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of nephrology,['10.1007/s40620-020-00943-6']
474,33564986,Greater Pain Severity Is Associated with Worse Outcomes in Patients with Heart Failure.,"We examined the relationship between pain severity and outcomes in patients with heart failure with reduced ejection fraction (HFrEF) in the HF-ACTION randomized controlled trial. Trends of health-related quality of life (HRQoL) measures grouped by patients' self-reported baseline bodily pain severity were compared using correlation tests, and the association between pain severity and clinical outcomes (including a primary composite endpoint of all-cause mortality and all-cause hospitalization) was assessed using multivariable adjusted analyses. Of the 2310 patients, 22.9% reported no pain, 45.8% very mild/mild, 24.9% moderate, and 6.4% severe/very severe. Greater pain severity was associated with worse HRQoL measures (EuroQoL-5D-3L and Kansas City Cardiomyopathy Questionnaire; both p < 0.0001). Compared to those reporting no pain, patients reporting severe/very severe pain had greater risk for the primary endpoint (adjusted hazard ratio 1.42, 95% confidence interval 1.11-1.83, p = 0.01). In patients with HFrEF, greater pain severity was associated with worse HRQoL and clinical outcomes. Trial Registration: NCT00047437.",2021,Greater pain severity was associated with worse HRQoL measures (EuroQoL-5D-3L and Kansas City Cardiomyopathy Questionnaire; both p < 0.0001).,"['Patients with Heart Failure', 'patients with heart failure with reduced ejection fraction (HFrEF) in the HF']",[],"['baseline bodily pain severity', 'pain severity', 'health-related quality of life (HRQoL) measures', 'Greater pain severity', 'HRQoL measures (EuroQoL-5D-3L and Kansas City Cardiomyopathy Questionnaire', 'pain severity and clinical outcomes', 'Greater Pain Severity', 'no pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0234225', 'cui_str': 'No pain'}]",2310.0,0.198306,Greater pain severity was associated with worse HRQoL measures (EuroQoL-5D-3L and Kansas City Cardiomyopathy Questionnaire; both p < 0.0001).,"[{'ForeName': 'Kent Y', 'Initials': 'KY', 'LastName': 'Feng', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University, 1070 Arastradero Rd, Suite 100, Palo Alto, CA, 94304, USA. kentfeng@stanford.edu.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Clare', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Alhanti', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Department of Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Department of Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}]",Journal of cardiovascular translational research,['10.1007/s12265-021-10104-0']
475,33542265,Repetitive visual cortex transcranial random noise stimulation in adults with amblyopia.,"We tested the hypothesis that five daily sessions of visual cortex transcranial random noise stimulation would improve contrast sensitivity, crowded and uncrowded visual acuity in adults with amblyopia. Nineteen adults with amblyopia (44.2 ± 14.9 years, 10 female) were randomly allocated to active or sham tRNS of the visual cortex (active, n = 9; sham, n = 10). Sixteen participants completed the study (n = 8 per group). tRNS was delivered for 25 min across five consecutive days. Monocular contrast sensitivity, uncrowded and crowded visual acuity were measured before, during, 5 min and 30 min post stimulation on each day. Active tRNS significantly improved contrast sensitivity and uncrowded visual acuity for both amblyopic and fellow eyes whereas sham stimulation had no effect. An analysis of the day by day effects revealed large within session improvements on day 1 for the active group that waned across subsequent days. No long-lasting (multi-day) improvements were observed for contrast sensitivity, however a long-lasting improvement in amblyopic eye uncrowded visual acuity was observed for the active group. This improvement remained at 28 day follow up. However, between-group differences in baseline uncrowded visual acuity complicate the interpretation of this effect. No effect of tRNS was observed for amblyopic eye crowded visual acuity. In agreement with previous non-invasive brain stimulation studies using different techniques, tRNS induced short-term contrast sensitivity improvements in adult amblyopic eyes, however, repeated sessions of tRNS did not lead to enhanced or long-lasting effects for the majority of outcome measures.",2021,Active tRNS significantly improved contrast sensitivity and uncrowded visual acuity for both amblyopic and fellow eyes whereas sham stimulation had no effect.,"['adult amblyopic eyes', '14.9\xa0years, 10 female', 'Nineteen adults with amblyopia (44.2\u2009±', 'adults with amblyopia', 'Sixteen participants completed the study (n\u2009=\u20098 per group']","['visual cortex transcranial random noise stimulation', 'Repetitive visual cortex transcranial random noise stimulation', 'active or sham tRNS of the visual cortex (active, n\u2009=\u20099; sham, n\u2009=\u200910', 'tRNS']","['Monocular contrast sensitivity, uncrowded and crowded visual acuity', 'amblyopic eye crowded visual acuity', 'contrast sensitivity, crowded and uncrowded visual acuity', 'contrast sensitivity and uncrowded visual acuity', 'amblyopic eye uncrowded visual acuity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0010383', 'cui_str': 'Crowding'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]",19.0,0.50467,Active tRNS significantly improved contrast sensitivity and uncrowded visual acuity for both amblyopic and fellow eyes whereas sham stimulation had no effect.,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Donkor', 'Affiliation': 'Department of Optometry and Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, ON, N0B 2T0, Canada.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Silva', 'Affiliation': 'Department of Optometry and Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, ON, N0B 2T0, Canada.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Teske', 'Affiliation': 'Department of Optometry and Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, ON, N0B 2T0, Canada.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Wallis-Duffy', 'Affiliation': 'Department of Optometry and Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, ON, N0B 2T0, Canada.'}, {'ForeName': 'Aaron P', 'Initials': 'AP', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'Department of Optometry and Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, ON, N0B 2T0, Canada. ben.thompson@uwaterloo.ca.'}]",Scientific reports,['10.1038/s41598-020-80843-8']
476,33544937,Assessing school-based intervention strategies to foster the prevention of choking injuries in children: The results of the CHOP (CHOking Prevention) trial.,"There are few public health programs aimed at reducing choking injuries, even though choking is one of the leading causes of death among unintentional injuries in young children. We present the results from the CHOP (CHOking Prevention) project community intervention trial, which aimed to compare three different school-based intervention strategies for food choking prevention. The trial enrolled 41 educational facilities, which were randomized to one of three different intervention strategies to inform about prevention of food choking, or to serve as the control group. In strategy A, education was delivered directly to families, whereas in strategy B, education was delivered first to teachers and by them to families, and in strategy C, education was delivered only to healthcare coordinators in each school and by them to teachers and families. All educational interventions were delivered in the schools by experts and certified trainers. The participants were asked about sociodemographic information and completed questionnaires (pre-, post- and follow-up of intervention). Information from the postintervention and follow-up questionnaires was synthesized into four indicators to evaluate the effectiveness of each intervention strategy. Of the 1,426 participants, 298 were involved in strategy A, 474 in strategy B, 491 in strategy C and 163 in the control group. At postintervention, the scores of the indicators in each strategy significantly outperformed those of the control group, with adjusted p < 0.05. At follow-up, the distribution of the indicator scores of each strategy was found to be not significantly different compared to those of the control group (p > 0.05). The results of this study suggest that a sustainable school-based public health intervention mediated by teachers is effective as direct training for families in improving knowledge about food choking injury prevention. Nevertheless, further improvements could be made to increase long-term information retention.",2021,"At postintervention, the scores of the indicators in each strategy significantly outperformed those of the control group, with adjusted p < 0.05.","['children', '41 educational facilities', '1,426 participants, 298 were involved in strategy A, 474 in strategy B, 491 in strategy C and 163 in the control group', 'young children']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]",[],[],41.0,0.0230945,"At postintervention, the scores of the indicators in each strategy significantly outperformed those of the control group, with adjusted p < 0.05.","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Lorenzoni', 'Affiliation': 'Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Lanera', 'Affiliation': 'Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Danila', 'Initials': 'D', 'LastName': 'Azzolina', 'Affiliation': 'Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Solidea', 'Initials': 'S', 'LastName': 'Baldas', 'Affiliation': 'Prochild Onlus, Trieste, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Messi', 'Affiliation': 'Department of Pediatrics, Burlo Garofolo, Trieste, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Gregori', 'Affiliation': 'Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}]",Health & social care in the community,['10.1111/hsc.13298']
477,33547330,The variant T allele of PvuII in ESR1 gene is a prognostic marker in early breast cancer survival.,"The PvuII (rs2234693) Single Nucleotide Polymorphism (SNP) in the gene coding for the estrogen receptor-1 (ESR1), has been found associated with outcome in tamoxifen treated patients with early hormone-receptor positive breast cancer. However, it remains unclear whether this SNP is a predictive marker for tamoxifen efficacy or a prognostic marker for breast cancer outcome. The aim of this study was to examine the prognostic potential of this SNP in postmenopausal early breast cancer patients treated with adjuvant exemestane. Dutch postmenopausal patients randomised to 5 years of adjuvant exemestane of whom tissue was available (N = 807) were selected from the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial database. The SNP rs2234693 in the ESR1 gene was genotyped on DNA from formalin-fixed paraffin embedded (FFPE) tumor tissue using Taqman assays and related to the primary endpoint disease-free survival (DFS) and secondary endpoint overall survival (OS). Survival analyses were performed using Cox regression analysis. In total 805 patients were included in the analyses (median follow up of 5.22 years) and genotypes were obtained in 97% of the samples. The variant T allele of PvuII in ESR1 (rs2234693) was associated with a better DFS (hazard ratio (HR) 0.689, 95% confidence interval (CI) 0.480-0.989, P = 0.044) in univariate analysis only, and a better OS in both univariate (HR 0.616, 95%, CI 0.411-0.923, P = 0.019) and multivariate analyses (HR 0.571, 95% CI 0.380-0.856, P = 0.007), consistent with a prognostic rather than a predictive drug response effect. Variation of PvuII in the ESR1 gene is related to OS in postmenopausal, early HR + breast cancer patients treated with exemestane in the TEAM study. Variation in the ESR1 gene may therefore be a prognostic marker of early breast cancer survival, and warrants further research.",2021,"(rs2234693) was associated with a better DFS (hazard ratio (HR) 0.689, 95% confidence interval (CI) 0.480-0.989, P = 0.044) in univariate analysis only, and a better OS in both univariate (HR 0.616, 95%, CI 0.411-0.923, P = 0.019) and multivariate analyses (HR 0.571, 95% CI 0.380-0.856, P = 0.007), consistent with a prognostic rather than a predictive drug response effect.","['postmenopausal early breast cancer patients treated with', 'postmenopausal, early HR\u2009+\u2009breast cancer patients treated with', 'Dutch postmenopausal patients randomised to 5\xa0years of adjuvant exemestane of whom tissue was available (N\u2009=\u2009807) were selected from the', 'treated patients with early hormone-receptor positive breast cancer', 'In total 805 patients']","['adjuvant exemestane', 'ESR1', 'exemestane', 'Tamoxifen Exemestane', 'tamoxifen']",[],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C1121711', 'cui_str': 'Estrogen Receptor 1'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]",[],805.0,0.0987744,"(rs2234693) was associated with a better DFS (hazard ratio (HR) 0.689, 95% confidence interval (CI) 0.480-0.989, P = 0.044) in univariate analysis only, and a better OS in both univariate (HR 0.616, 95%, CI 0.411-0.923, P = 0.019) and multivariate analyses (HR 0.571, 95% CI 0.380-0.856, P = 0.007), consistent with a prognostic rather than a predictive drug response effect.","[{'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Houtsma', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, Leiden, 2300 RC, The Netherlands.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, Leiden, 2300 RC, The Netherlands. s.de_groot2@lumc.nl.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Baak-Pablo', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Elma Meershoek-Klein', 'Initials': 'EM', 'LastName': 'Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Seynaeve', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Böhringer', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, Leiden, 2300 RC, The Netherlands.'}, {'ForeName': 'Henk -Jan', 'Initials': 'H-', 'LastName': 'Guchelaar', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, Leiden, 2300 RC, The Netherlands.'}]",Scientific reports,['10.1038/s41598-021-82002-z']
478,33555430,Modified intestinal isolation bag as promising tool in promoting bowel resumption after ovarian cancer cytoreductive surgery: a randomized clinical trial.,"PURPOSE


Postoperative ileus (POI) impairs patient recovery, prolonging hospital stay after major surgery in ovarian cancer (OvCa) patients. Thus, intraoperative bowel isolation is expected to reduce manipulation-related impairment. The aim of this study was to investigate the impact of intraoperative intestinal isolation bag on POI in OvCa patients submitted to primary surgery.
METHODS


A randomized trial including patients managed with or without isolation bag during OvCa primary surgery was conducted. Patients were selected by consecutive randomization. Primary endpoints were the time between surgery and resumption of bowel motility (as passage of first/continued flatus), assessing of postoperative nausea or vomiting and return to regular diet. Secondary endpoint was the impact of intestinal isolation bag on length of hospitalization in the two groups.
RESULTS


Ninety-two patients respecting inclusion criteria were eligible to be enrolled in the study (48 patients as Group 1 and 44 patients as Group 2). Thirty-eight (79.2%) patients, in which intraoperative isolation bag was used, experienced first/continued flatus within 3 days from surgery and they were susceptible to be discharged within 5 days, compared, respectively, to 34.3% of Group 2 (n = 15). Advantages were more evident in patients whose surgery took over 220 min (OR 0.02, CI 95% 0.001-0.57; p < 0.001) despite the type of surgical effort made.
CONCLUSION


Despite the small sample size, our study showed that the use of intestinal isolation bag can reduce incidence of POI and length of stay in OvCa patients submitted to primary cytoreductive surgery.",2021,"Advantages were more evident in patients whose surgery took over 220 min (OR 0.02, CI 95% 0.001-0.57; p < 0.001) despite the type of surgical effort made.
","['ovarian cancer (OvCa) patients', 'OvCa patients submitted to primary surgery', 'OvCa patients submitted to primary cytoreductive surgery', 'Ninety-two patients respecting inclusion criteria were eligible to be enrolled in the study (48 patients as Group 1 and 44 patients as Group 2', 'patients managed with or without isolation bag during OvCa primary surgery was conducted', 'ovarian cancer cytoreductive surgery']","['intraoperative intestinal isolation bag on POI', 'Modified intestinal isolation bag']","['time between surgery and resumption of bowel motility (as passage of first/continued flatus), assessing of postoperative nausea or vomiting and return to regular diet', 'incidence of POI and length of stay', 'hospital stay', 'impact of intestinal isolation bag on length of hospitalization']","[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0934088,"Advantages were more evident in patients whose surgery took over 220 min (OR 0.02, CI 95% 0.001-0.57; p < 0.001) despite the type of surgical effort made.
","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Perutelli', 'Affiliation': 'Second Division of Obstetrics and Gynecology, Department of Experimental and Clinical Medicine, Santa Chiara University Hospital, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Ferrandina', 'Affiliation': 'Department of Health of Woman and Child, Gynecologic Oncology Unit, Catholic University of Sacred Heart, Rome, Italy.'}, {'ForeName': 'Lavinia', 'Initials': 'L', 'LastName': 'Domenici', 'Affiliation': 'Second Division of Obstetrics and Gynecology, Department of Experimental and Clinical Medicine, Santa Chiara University Hospital, University of Pisa, Pisa, Italy. lavinia.domenici@uniroma1.it.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Cubeddu', 'Affiliation': 'Second Division of Obstetrics and Gynecology, Department of Experimental and Clinical Medicine, Santa Chiara University Hospital, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Garibaldi', 'Affiliation': 'Second Division of Obstetrics and Gynecology, Department of Experimental and Clinical Medicine, Santa Chiara University Hospital, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Aretini', 'Affiliation': 'Pisa Science Foundation, Pisa, Italy.'}, {'ForeName': 'Chiara Maria', 'Initials': 'CM', 'LastName': 'Mazzanti', 'Affiliation': 'Pisa Science Foundation, Pisa, Italy.'}, {'ForeName': 'Maria Giovanna', 'Initials': 'MG', 'LastName': 'Salerno', 'Affiliation': 'Second Division of Obstetrics and Gynecology, Department of Experimental and Clinical Medicine, Santa Chiara University Hospital, University of Pisa, Pisa, Italy.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-021-05981-4']
479,33548860,"Nanoparticle albumin-bound paclitaxel with cetuximab and carboplatin as first-line therapy for recurrent or metastatic head and neck cancer: A single-arm, multicenter, phase 2 trial.","OBJECTIVES


Macropinocytosis promotes internalization of albumin into cells to serve as a nutrient supply and is constitutively driven by signaling pathways frequently hyperactivated in head and neck squamous-cell carcinoma (HNSCC). In this way, drugs bound to albumin may selectively target HNSCC. nab-paclitaxel is a nanoparticle albumin-bound formulation of paclitaxel that improves drug delivery into tumor compared to paclitaxel. The primary aim of this single-arm, multicenter, phase 2 trial was to determine if nab-paclitaxel, cetuximab, and carboplatin (CACTUX regimen) would result in longer progression-free survival (PFS) than the historical regimen (EXTREME: 5-fluorouracil, cetuximab, and a platinum).
MATERIALS AND METHODS


Patients with untreated recurrent or metastatic HNSCC received six, three-week cycles of nab-paclitaxel, cetuximab, and carboplatin, followed by maintenance nab-paclitaxel and cetuximab until progression. We hypothesized the median PFS with CACTUX would be 35% longer than with EXTREME (corresponding to 7.6 vs 5.6 months; power 0.80, α = 0.05, one-sided test, n = 70). Secondary outcomes included objective response rate (ORR) and overall survival (OS).
RESULTS


Seventy-four patients enrolled into the trial; seventy were evaluable. The median PFS was 6.1 months (95% CI, 4.1-7.4). The ORR was 60%. Median follow-up was 18 months (IQR: 4.7-23). The median OS was 17.8 months (95% CI, 8.5-21.7) for all patients, and 19.8 months (95% CI, 10.9-22.0) for human papillomavirus (HPV)-related oropharynx SCC and 14.0 months (95% CI, 4.6-23.3) for HPV-unrelated HNSCC.
CONCLUSION


Among patients with recurrent or metastatic HNSCC, CACTUX did not result in a longer PFS than historical EXTREME. However, CACTUX did result in a more favorable ORR and OS.",2021,"The median OS was 17.8 months (95% CI, 8.5-21.7) for all patients, and 19.8 months (95% CI, 10.9-22.0) for human papillomavirus (HPV)-related oropharynx SCC and 14.0 months (95% CI, 4.6-23.3) for HPV-unrelated HNSCC.
","['patients with recurrent or metastatic HNSCC', 'Seventy-four patients enrolled into the trial; seventy were evaluable', 'recurrent or metastatic head and neck cancer', 'head and neck squamous-cell carcinoma (HNSCC', 'Patients with untreated recurrent or metastatic HNSCC received six, three-week cycles of']","['CACTUX', 'nab-paclitaxel', 'Nanoparticle albumin-bound paclitaxel with cetuximab and carboplatin', 'nab-paclitaxel, cetuximab, and carboplatin, followed by maintenance nab-paclitaxel and cetuximab until progression', '5-fluorouracil, cetuximab, and a platinum', 'nab-paclitaxel, cetuximab, and carboplatin (CACTUX regimen']","['longer progression-free survival (PFS', 'median PFS with CACTUX', 'ORR', 'median PFS', 'objective response rate (ORR) and overall survival (OS', 'median OS', 'favorable ORR and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0744620', 'cui_str': 'Squamous cell carcinoma of head and neck metastatic'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0744619', 'cui_str': 'Head and neck cancer metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",74.0,0.086168,"The median OS was 17.8 months (95% CI, 8.5-21.7) for all patients, and 19.8 months (95% CI, 10.9-22.0) for human papillomavirus (HPV)-related oropharynx SCC and 14.0 months (95% CI, 4.6-23.3) for HPV-unrelated HNSCC.
","[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Adkins', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States. Electronic address: dadkins@wustl.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ley', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Atiq', 'Affiliation': 'Winthrop P. Rockefeller Cancer Institute, University of Arkansas Medical System, Little Rock, AR, United States.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Powell', 'Affiliation': 'Sanford Cancer Center, Sanford Health, Sioux Falls, SD, United States.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Spanos', 'Affiliation': 'Sanford Cancer Center, Sanford Health, Sioux Falls, SD, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gitau', 'Affiliation': 'Sanford Cancer Center, Sanford Health, Fargo, ND, United States.'}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Rigden', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Palka', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Biostatistics Shared Resource, Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oppelt', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105173']
480,33542383,Dual n-back working memory training evinces superior transfer effects compared to the method of loci.,"Working memory (WM) training is a prevalent intervention for multiple cognitive deficits, however, the transfer effects to other cognitive tasks from gains in WM induced by different training techniques still remains controversial. Therefore, the current study recruited three groups of young adults to investigate the memory training transference, with N-back group (NBG) (n = 50) training on dual n-back task, Memory Palace group (MPG) (n = 50) on method of loci, and a blank control group (BCG) (n = 48) receiving no training. Our results showed that both training groups separately improved WM capacity on respective trained task. For untrained tasks, both training groups enhanced performance on digit-span task, while on change detection task, significant improvement was only observed in NBG. In conclusion, while both techniques can be used as effective training methods to improve WM, the dual n-back task training method, perhaps has a more prominent transfer effect than that of method of loci.",2021,"For untrained tasks, both training groups enhanced performance on digit-span task, while on change detection task, significant improvement was only observed in NBG.",[],"['memory training transference, with N-back group (NBG) (n\u2009=\u200950) training on dual n-back task, Memory Palace group (MPG) (n\u2009=\u200950) on method of loci, and a blank control group (BCG) (n\u2009=\u200948) receiving no training', 'Working memory (WM) training']","['WM capacity', 'NBG', 'digit-span task']",[],"[{'cui': 'C0729377', 'cui_str': 'Memory skills training'}, {'cui': 'C0040678', 'cui_str': 'Transference'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}]",,0.0120333,"For untrained tasks, both training groups enhanced performance on digit-span task, while on change detection task, significant improvement was only observed in NBG.","[{'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Key Laboratory for NeuroInformation of Ministry of Education, High-Field Magnetic Resonance Brain Imaging Key Laboratory of Sichuan Province, Center for Psychiatry and Psychology, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, 610054, China.'}, {'ForeName': 'Qiuzhu', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory for NeuroInformation of Ministry of Education, High-Field Magnetic Resonance Brain Imaging Key Laboratory of Sichuan Province, Center for Psychiatry and Psychology, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, 610054, China.'}, {'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Qiao', 'Affiliation': 'Key Laboratory for NeuroInformation of Ministry of Education, High-Field Magnetic Resonance Brain Imaging Key Laboratory of Sichuan Province, Center for Psychiatry and Psychology, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, 610054, China.'}, {'ForeName': 'Donggang', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Key Laboratory for NeuroInformation of Ministry of Education, High-Field Magnetic Resonance Brain Imaging Key Laboratory of Sichuan Province, Center for Psychiatry and Psychology, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, 610054, China.'}, {'ForeName': 'Ronald K', 'Initials': 'RK', 'LastName': 'Ngetich', 'Affiliation': 'Key Laboratory for NeuroInformation of Ministry of Education, High-Field Magnetic Resonance Brain Imaging Key Laboratory of Sichuan Province, Center for Psychiatry and Psychology, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, 610054, China.'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory for NeuroInformation of Ministry of Education, High-Field Magnetic Resonance Brain Imaging Key Laboratory of Sichuan Province, Center for Psychiatry and Psychology, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, 610054, China.'}, {'ForeName': 'Zhenlan', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Key Laboratory for NeuroInformation of Ministry of Education, High-Field Magnetic Resonance Brain Imaging Key Laboratory of Sichuan Province, Center for Psychiatry and Psychology, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, 610054, China. jinzl@uestc.edu.cn.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Key Laboratory for NeuroInformation of Ministry of Education, High-Field Magnetic Resonance Brain Imaging Key Laboratory of Sichuan Province, Center for Psychiatry and Psychology, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, 610054, China. liling@uestc.edu.cn.'}]",Scientific reports,['10.1038/s41598-021-82663-w']
481,33560659,The Effect of Low-Dose Intraoperative Ketamine on Closed-Loop-Controlled General Anesthesia: A Randomized Controlled Equivalence Trial.,"BACKGROUND


Closed-loop control of propofol-remifentanil anesthesia using the processed electroencephalography depth-of-hypnosis index provided by the NeuroSENSE monitor (WAVCNS) has been previously described. The purpose of this placebo-controlled study was to evaluate the performance (percentage time within ±10 units of the setpoint during the maintenance of anesthesia) of a closed-loop propofol-remifentanil controller during induction and maintenance of anesthesia in the presence of a low dose of ketamine.
METHODS


Following ethical approval and informed consent, American Society of Anesthesiologist (ASA) physical status I-II patients aged 19-54 years, scheduled for elective orthopedic surgery requiring general anesthesia for >60 minutes duration, were enrolled in a double-blind randomized, placebo-controlled, 2-group equivalence trial. Immediately before induction of anesthesia, participants in the ketamine group received a 0.25 mg·kg-1 bolus of intravenous ketamine over 60 seconds followed by a continuous 5 µg·kg-1·min-1 infusion for up to 45 minutes. Participants in the control group received an equivalent volume of normal saline. After the initial study drug bolus, closed-loop induction of anesthesia was initiated; propofol and remifentanil remained under closed-loop control until the anesthetic was tapered and turned off at the anesthesiologist's discretion. An equivalence range of ±8.99% was assumed for comparing controller performance.
RESULTS


Sixty patients participated: 41 males, 54 ASA physical status I, with a median (interquartile range [IQR]) age of 29 [23, 38] years and weight of 82 [71, 93] kg. Complete data were available from 29 cases in the ketamine group and 27 in the control group. Percentage time within ±10 units of the WAVCNS setpoint was median [IQR] 86.6% [79.7, 90.2] in the ketamine group and 86.4% [76.5, 89.8] in the control group (median difference, 1.0%; 95% confidence interval [CI] -3.6 to 5.0). Mean propofol dose during maintenance of anesthesia for the ketamine group was higher than for the control group (median difference, 24.9 µg·kg-1·min-1; 95% CI, 6.5-43.1; P = .005).
CONCLUSIONS


Because the 95% CI of the difference in controller performance lies entirely within the a priori equivalence range, we infer that this analgesic dose of ketamine did not alter controller performance. Further study is required to confirm the finding that mean propofol dosing was higher in the ketamine group, and to investigate the implication that this dose of ketamine may have affected the WAVCNS.",2021,"Mean propofol dose during maintenance of anesthesia for the ketamine group was higher than for the control group (median difference, 24.9 µg·kg-1·min-1; 95% CI, 6.5-43.1; P = .005).
","['Sixty patients participated: 41 males, 54 ASA physical status', 'Following ethical approval and informed consent, American Society of Anesthesiologist (ASA) physical status I-II patients aged 19-54 years, scheduled for elective orthopedic surgery requiring general anesthesia for >60 minutes duration', 'Closed-Loop-Controlled General Anesthesia', '29 [23, 38] years and weight of 82 [71, 93] kg']","['Low-Dose Intraoperative Ketamine', 'ketamine', 'propofol and remifentanil', 'placebo', 'closed-loop propofol-remifentanil controller', 'propofol-remifentanil anesthesia', 'equivalent volume of normal saline']",['controller performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]",[],54.0,0.426593,"Mean propofol dose during maintenance of anesthesia for the ketamine group was higher than for the control group (median difference, 24.9 µg·kg-1·min-1; 95% CI, 6.5-43.1; P = .005).
","[{'ForeName': 'Gabby', 'Initials': 'G', 'LastName': 'Napoleone', 'Affiliation': 'From the Departments of Anesthesiology, Pharmacology and Therapeutics.'}, {'ForeName': 'Klaske', 'Initials': 'K', 'LastName': 'van Heusden', 'Affiliation': 'Electrical and Computer Engineering, University of British Columbia (UBC), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cooke', 'Affiliation': 'From the Departments of Anesthesiology, Pharmacology and Therapeutics.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'West', 'Affiliation': 'From the Departments of Anesthesiology, Pharmacology and Therapeutics.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Görges', 'Affiliation': 'From the Departments of Anesthesiology, Pharmacology and Therapeutics.'}, {'ForeName': 'Guy A', 'Initials': 'GA', 'LastName': 'Dumont', 'Affiliation': 'Electrical and Computer Engineering, University of British Columbia (UBC), Vancouver, British Columbia, Canada.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'Ansermino', 'Affiliation': 'From the Departments of Anesthesiology, Pharmacology and Therapeutics.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Merchant', 'Affiliation': 'From the Departments of Anesthesiology, Pharmacology and Therapeutics.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005372']
482,33542275,Probiotics as a treatment for prenatal maternal anxiety and depression: a double-blind randomized pilot trial.,"Probiotic use may be an efficacious treatment option to effectively manage symptoms of prenatal maternal anxiety and depression. Our primary aim was to test feasibility and acceptability for a probiotic randomized controlled trial (RCT) in pregnant women with pre-existing symptoms. This double-blind pilot RCT included 40 pregnant women with low-risk pregnancies and elevated depressive symptoms and/or anxiety. Once daily, participants orally consumed a probiotic (Ecologic Barrier) or a placebo, from 26 to 30 weeks gestation until delivery. A priori key progression criteria for primary outcomes were determined to decide whether or not a full RCT was feasible and acceptable. Secondary outcomes included depressive symptoms, anxiety, stress, and maternal bonding to offspring. In 19 months, 1573 women were screened; following screening, 155 women (10%) were invited for participation, of whom 135 (87%) received study information, and 40 women (30%) were included. Four out of six a priori determined criteria for success on feasibility and acceptability were met. After 8 weeks of intervention, there was no significant difference between the probiotic and placebo groups for secondary outcomes. The pilot trial was feasible and acceptable, but hampered by recruitment method and study design. Secondary endpoints did not reveal differences between the groups for improving maternal mood.",2021,Secondary endpoints did not reveal differences between the groups for improving maternal mood.,"['prenatal maternal anxiety and depression', 'In 19\xa0months, 1573 women were screened; following screening, 155 women (10%) were invited for participation, of whom 135 (87%) received study information, and 40 women (30%) were included', 'pregnant women with pre-existing symptoms', '40 pregnant women with low-risk pregnancies and elevated depressive symptoms and/or anxiety']","['Probiotics', 'probiotic (Ecologic Barrier) or a placebo', 'placebo']","['feasibility and acceptability', 'maternal mood', 'depressive symptoms, anxiety, stress, and maternal bonding to offspring']","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0404841', 'cui_str': 'Low risk pregnancy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",1573.0,0.692567,Secondary endpoints did not reveal differences between the groups for improving maternal mood.,"[{'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Browne', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Kapittelweg 29, 6525 EN, Nijmegen, The Netherlands. Pamela.Browne@radboudumc.nl.'}, {'ForeName': 'Antoinette C', 'Initials': 'AC', 'LastName': 'Bolte', 'Affiliation': 'Department of Obstetrics and Gynecology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Isolde', 'Initials': 'I', 'LastName': 'Besseling-van der Vaart', 'Affiliation': 'Winclove Probiotics BV, Amsterdam, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Claassen', 'Affiliation': 'Faculty of Earth and Life Sciences, Athena Institute, VU University, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'de Weerth', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Kapittelweg 29, 6525 EN, Nijmegen, The Netherlands. Carolina.deWeerth@radboudumc.nl.'}]",Scientific reports,['10.1038/s41598-021-81204-9']
483,33559816,The Effect of Solution-Oriented Counseling on Coping Strategies in Mental Health Issues in Women with Gestational Diabetes.,"This study aimed to investigate the effectiveness of solution-oriented intervention in patients with gestational diabetes, stress and anxiety on using coping strategies. This study was a randomized clinical trial with a control group. The population consisted of 56 diabetic women under treatment with insulin, who obtained higher score in one of the psychological disorders using DASS-21 (Depression, anxiety, stress scale). The participants were randomly assigned in two interventional (n = 28) and control (n = 28) groups after signing the written informed consent forms. The solution-oriented interventional program was conducted in six 60-min sessions for 6 weeks. Immediately after the final session and 6-8 weeks after the first session of the intervention, both groups completed coping inventory for stressful situations. The analytical statistic of t-test, chi-square, and variance analysis with repeated measurements using SPSS were used to analyze the data. solution-oriented counseling increased the problem-solving coping strategy in the intervention group (P = 0.001); the scores obtained by the subjects in the interventional group after adjusting the score before the intervention increased 2.68 units immediately after the intervention, which was not statistically significant (p-value = 0.44). However, it increased 11.5 scores six weeks after the intervention, which was statistically significant (P = 0.00). But, emotional and avoidance coping strategies were not significantly different between the two groups. This technique can be easily trained to all clients, and since it is focused on finding various solutions for psychological problems by clients, it can be used to reduce stress and anxiety in other chronic diseases as well.IRCT code: The code of this clinical trial study is IRCT20200202046339N1.",2021,"solution-oriented counseling increased the problem-solving coping strategy in the intervention group (P = 0.001); the scores obtained by the subjects in the interventional group after adjusting the score before the intervention increased 2.68 units immediately after the intervention, which was not statistically significant (p-value = 0.44).","['Women with Gestational Diabetes', '56 diabetic women under treatment with insulin, who obtained higher score in one of the psychological disorders using DASS-21 (Depression, anxiety, stress scale', 'patients with gestational diabetes, stress and anxiety on using coping strategies']","['Solution-Oriented Counseling', 'solution-oriented intervention', 'IRCT code']","['problem-solving coping strategy', 'emotional and avoidance coping strategies']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009219', 'cui_str': 'Coding'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",56.0,0.0445292,"solution-oriented counseling increased the problem-solving coping strategy in the intervention group (P = 0.001); the scores obtained by the subjects in the interventional group after adjusting the score before the intervention increased 2.68 units immediately after the intervention, which was not statistically significant (p-value = 0.44).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rafie', 'Affiliation': 'School of Medicine, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Katayon', 'Initials': 'K', 'LastName': 'Vakilian', 'Affiliation': 'Department of Midwifery, School of Medicine, Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Basij Square, Sardasht Region, Peyambare-Azam Bliding, Arak, Iran. dr.kvakilian@arakmu.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zamanian', 'Affiliation': 'Department of Epidemiology, School of Health, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Eghbali', 'Affiliation': 'Clinical Psychology, Semnan Azad University, Semnan, Iran.'}]",Administration and policy in mental health,['10.1007/s10488-021-01111-z']
484,33559686,Guided vs. non-guided insertion of Ambu AuraGain™ in edentulous patients.,"BACKGROUND


Supraglottic airway devices perform more poorly and have lower oropharyngeal leak pressure in edentulous patients than in patients with teeth. The Ambu Aura Gain is a newer second generation supraglottic airway device.
OBJECTIVE


This randomized clinical trial assessed the oropharyngeal leak pressure in edentulous patients using the Ambu Aura Gain with a gastric tube for insertion guidance and without insertion guidance.
MATERIAL AND METHODS


Patients with ASA (American Society of Anesthesiology) physical status I-III were recruited. Primary outcome was oropharyngeal leak pressure after insertion. Secondary outcome parameters were oropharyngeal leak pressure 15 min and 30 min after insertion, insertion time, insertion attempts and glottis view through flexible fiberscope.
RESULTS


In this study 72 patients aged between 51 and 90 years (mean 73 years) were randomly allocated to the ""with guidance"" (n = 36) or the ""without guidance"" group (n = 36). Mean (SD) oropharyngeal leak pressure in ""with guidance"" and ""without guidance"" group was 24 cm H 2 O and 24 cm H 2 O (ns), respectively. A difference was found in mean insertion time with guidance versus without guidance group 52 s (45 s) vs. 26 s (15 s) (p < 0.001). No difference was found in any of the other secondary outcome parameters.
CONCLUSION


A guided insertion technique does not improve oropharyngeal leak pressure of the Ambu AuraGain™ in edentulous patients. As the only difference is an increase in insertion time this technique is of no benefit for this population.",2021,A difference was found in mean insertion time with guidance versus without guidance group 52 ,"['edentulous patients than in patients with teeth', 'edentulous patients', 'Patients with ASA (American Society of Anesthesiology) physical status I-III were recruited', 'edentulous patients using the Ambu Aura Gain with a\xa0gastric tube for insertion guidance and without insertion guidance', '72\xa0patients aged between\xa051 and\xa090 years (mean\xa073 years']","['Guided vs. non-guided insertion of Ambu AuraGain', 'without guidance"" group', 'with guidance']","['oropharyngeal leak pressure\xa015\u202fmin and 30\u202fmin after insertion, insertion time, insertion attempts and glottis view through flexible fiberscope', 'Mean (SD) oropharyngeal leak pressure', 'mean insertion time', 'oropharyngeal leak pressure']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.133591,A difference was found in mean insertion time with guidance versus without guidance group 52 ,"[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Gasteiger', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Medical University Innsbruck, Anichstraße\xa035, A-6020, Innsbruck, Austria.'}, {'ForeName': 'Helmuth', 'Initials': 'H', 'LastName': 'Tauber', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Medical University Innsbruck, Anichstraße\xa035, A-6020, Innsbruck, Austria. Helmuth.tauber@tirol-kliniken.at.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Velik-Salchner', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Medical University Innsbruck, Anichstraße\xa035, A-6020, Innsbruck, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Thoma', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Medical University Innsbruck, Anichstraße\xa035, A-6020, Innsbruck, Austria.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Fantin', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Medical University Innsbruck, Anichstraße\xa035, A-6020, Innsbruck, Austria.'}, {'ForeName': 'Vitaliy', 'Initials': 'V', 'LastName': 'Pustilnik', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Medical University Innsbruck, Anichstraße\xa035, A-6020, Innsbruck, Austria.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Neururer', 'Affiliation': 'Department of Medical Statistics, Informatics and Health Economics, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Keller', 'Affiliation': 'Department of Anaesthesiology, Schulthess Klinik, Schulthess, Switzerland.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Moser', 'Affiliation': 'Department of Anaesthesiology, Spital Limmattal, Zurich, Switzerland.'}]",Der Anaesthesist,['10.1007/s00101-021-00914-x']
485,33555974,Effectiveness of Pulmonary Surfactant in the Treatment of Corneal Edema.,"Purpose:  To compare the effectiveness of topical surfactant and 3% sodium chloride (NaCl) in the treatment of corneal edema occurring after cataract surgery.  Methods:  Ninety eyes of 90 patients with no corneal disease who underwent cataract surgery were included in the study. Thirty eyes without corneal edema comprised group 1. Patients with corneal edema were divided into two groups: those treated with 3% NaCl (group 2, 30 eyes) and those treated with surfactant drop (group 3, 30 eyes).  Results:  The mean age was 70.8 ± 6.6 years, with no significant age difference between the groups. Preoperatively, there was no significant difference in mean central corneal thickness (CCT) or mean endothelial cell count (ECC) among the groups ( P  = 0.999). On postoperative day 1, CCT was significantly lower in group 1 ( P  < 0.001) but did not differ between groups 2 and 3 ( P  = 0.999). There was no significant difference between groups in terms of ECC ( P  > 0.05). At postoperative day 7 and 14, CCT differed significantly between groups 1 and 2 ( P  < 0.001) and between groups 2 and 3 ( P  = 0.001), with no significant difference between groups 1 and 3 ( P  = 0.474). ECC was significantly higher in group 1 ( P  < 0.05), whereas there was no significant difference between groups 2 and 3 ( P  > 0.05).  Conclusion:  Topical pulmonary surfactant may be a more effective treatment option than 3% hypertonic NaCl for the treatment of corneal edema that develops after cataract surgery.",2021,"At postoperative day 7 and 14, CCT differed significantly between groups 1 and 2 ( P  < 0.001) and between groups 2 and 3 ( P  = 0.001), with no significant difference between groups 1 and 3 ( P  = 0.474).","['Corneal Edema', 'Ninety eyes of 90 patients with no corneal disease who underwent cataract surgery were included in the study', 'Patients with corneal edema', 'Thirty eyes without corneal edema comprised group 1', 'corneal edema occurring after cataract surgery']","['topical surfactant and 3% sodium chloride (NaCl', 'NaCl', 'Topical pulmonary surfactant', 'Pulmonary Surfactant', 'surfactant drop', 'hypertonic NaCl']","['mean central corneal thickness (CCT) or mean endothelial cell count (ECC', 'ECC']","[{'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010034', 'cui_str': 'Disorder of cornea'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}]",90.0,0.0161678,"At postoperative day 7 and 14, CCT differed significantly between groups 1 and 2 ( P  < 0.001) and between groups 2 and 3 ( P  = 0.001), with no significant difference between groups 1 and 3 ( P  = 0.474).","[{'ForeName': 'Tuncay', 'Initials': 'T', 'LastName': 'Artuç', 'Affiliation': 'Nusaybin Public Hospital, Eye Clinic, Mardin, Turkey.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Batur', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Erbil', 'Initials': 'E', 'LastName': 'Seven', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Serek', 'Initials': 'S', 'LastName': 'Tekin', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Muhammet Derda', 'Initials': 'MD', 'LastName': 'Özer', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2020.0121']
486,33563040,Quality-adjusted survival in patients with metastatic colorectal cancer treated with fruquintinib in the FRESCO trial.,"Aim:  To assess whether the survival benefit of fruquintinib is quality-adjusted.  Materials & methods:  Data of 416 metastatic colorectal cancer patients from the Phase III FRESCO trial were used. The Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) analysis assessed the quality-adjusted survival benefit of fruquintinib versus placebo, accounting for freedom from symptomatic disease and from severe side effects of treatment.  Results:  Fruquintinib significantly improved patients' Q-TWiST (difference: 2.23 [1.41, 3.04] months) versus placebo. The Q-TWiST gain was 28.3% in the base case and ranged from 16.7 to 39.9% in the threshold analysis, favoring fruquintinib. The Q-TWiST benefit was observed in fruquintinib-treated patients regardless of prior targeted therapy.  Conclusion:  Fruquintinib provides a clinically meaningful quality-adjusted survival benefit versus placebo as a third-line treatment for metastatic colorectal cancer patients.",2021,"significantly improved patients' Q-TWiST (difference: 2.23 [1.41, 3.04] months) versus placebo.","['416 metastatic colorectal cancer\xa0patients from the Phase III FRESCO trial were used', 'patients with metastatic colorectal cancer treated with fruquintinib in FRESCO trial', 'metastatic colorectal cancer patients']",['placebo'],"['Q-TWiST gain', 'Q-TWiST benefit', 'quality-adjusted survival benefit', 'Quality-adjusted survival', 'Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040480', 'cui_str': 'Torsion'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",416.0,0.343916,"significantly improved patients' Q-TWiST (difference: 2.23 [1.41, 3.04] months) versus placebo.","[{'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Department of Medical Oncology, Cancer Center of Jinling Hospital, Nanjing, 210029, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Tongji University East Hospital, Department of Medical Oncology, Shanghai, 200120, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Harbin Medical University Cancer Hospital, Department of Medical Oncology, Harbin, 120081, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Oncology, The Sixth Hospital Affiliated to Sun Yat-Sen University, Guangzhou, 510655, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Nantong Tumor Hospital, Department of medical oncology, Nantong, 226361, China.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Sun Yat-Sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Zhejiang Cancer Hospital, Department of Medical Oncology, Hangzhou, 310022, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Second Hospital of Anhui Medical University, Department of Medical Oncology, Hefei, 230601, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital, Department of Medical Oncology, Hangzhou, 310020, China.'}, {'ForeName': 'Weijian', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai Medical College, Department of Medical Oncology, Shanghai, 200032, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Jiangsu Provincial Hospital, Department of Medical Oncology, Nanjing, 210029, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': '307th Hospital of Chinese PLA-The Affiliated Hospital of Military Medical Sciences, Department of Medical Oncology, Beijing, 100071, China.'}, {'ForeName': 'Cike', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Eli Lilly & Company China Affiliate, Lilly China Drug Development & Medical Affairs Center, Shanghai, 200041, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Eli Lilly & Company China Affiliate, Lilly China Drug Development & Medical Affairs Center, Shanghai, 200041, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Eli Lilly & Company China Affiliate, Lilly China Drug Development & Medical Affairs Center, Shanghai, 200041, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly & Company China Affiliate, Lilly China Drug Development & Medical Affairs Center, Shanghai, 200041, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, 201203, China.'}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, 201203, China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, 201203, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis & Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100048, China.'}]","Future oncology (London, England)",['10.2217/fon-2020-1215']
487,33570248,Achieving optimal adherence to medical therapy by telehealth: Findings from the ORBITA medication adherence sub-study.,"INTRODUCTION


The ORBITA trial of percutaneous coronary intervention (PCI) versus a placebo procedure for patients with stable angina was conducted across six sites in the United Kingdom via home monitoring and telephone consultations. Patients underwent detailed assessment of medication adherence which allowed us to measure the efficacy of the implementation of the optimization protocol and interpretation of the main trial endpoints.
METHODS


Prescribing data were collected throughout the trial. Self-reported adherence was assessed, and urine samples collected at pre-randomization and at follow-up for direct assessment of adherence using high-performance liquid chromatography with tandem mass spectrometry (HPLC MS/MS).
RESULTS


Self-reported adherence was >96% for all drugs in both treatment groups at both stages. The percentage of samples in which drug was detected at pre-randomization and at follow-up in the PCI versus placebo groups respectively was: clopidogrel, 96% versus 90% and 98% versus 94%; atorvastatin, 95% versus 92% and 92% versus 91%; perindopril, 95% versus 97% and 85% versus 100%; bisoprolol, 98% versus 99% and 96% versus 97%; amlodipine, 99% versus 99% and 94% versus 96%; nicorandil, 98% versus 96% and 94% versus 92%; ivabradine, 100% versus 100% and 100% versus 100%; and ranolazine, 100% versus 100% and 100% versus 100%.
CONCLUSIONS


Adherence levels were high throughout the study when quantified by self-reporting methods and similarly high proportions of drug were detected by urinary assay. The results indicate successful implementation of the optimization protocol delivered by telephone, an approach that could serve as a model for treatment of chronic conditions, particularly as consultations are increasingly conducted online.",2021,Self-reported adherence was >96% for all drugs in both treatment groups at both stages.,['patients with stable angina was conducted across six sites in the United Kingdom via home monitoring and telephone consultations'],"['ranolazine', 'placebo', 'percutaneous coronary intervention (PCI', 'perindopril', 'placebo procedure', 'amlodipine', 'nicorandil', 'atorvastatin']",['Self-reported adherence'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}]","[{'cui': 'C0073633', 'cui_str': 'ranolazine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0320677,Self-reported adherence was >96% for all drugs in both treatment groups at both stages.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Al-Lamee', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Foley', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Hakim M', 'Initials': 'HM', 'LastName': 'Dehbi', 'Affiliation': 'Comprehensive Clinical Trials Unit at UCL, University College London, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thom', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Darrel P', 'Initials': 'DP', 'LastName': 'Francis', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Department of Chemical Pathology and Metabolic Diseases, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Chemical Pathology and Metabolic Diseases, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pharmacology research & perspectives,['10.1002/prp2.710']
488,33531522,Effects of very low volume high intensity versus moderate intensity interval training in obese metabolic syndrome patients: a randomized controlled study.,"Physical activity is a cornerstone in the treatment of obesity and metabolic syndrome (MetS). Given the leading physical activity barrier of time commitment and safety concerns about vigorous exercise in high-risk groups, this study aimed to investigate the effects of two extremely time-efficient training protocols (< 30 min time effort per week), either performed as high- (HIIT) or moderate-intensity interval training (MIIT) over 12 weeks, in obese MetS patients. In total, 117 patients (49.8 ± 13.6 years, BMI: 38.2 ± 6.2 kg/m 2 ) were randomized to HIIT (n = 40), MIIT (n = 37) or an inactive control group (n = 40). All groups received nutritional counseling to support weight loss. Maximal oxygen uptake (VO 2max ), MetS severity (MetS z-score), body composition and quality of life (QoL) were assessed pre-and post-intervention. All groups significantly reduced body weight (~ 3%) but only the exercise groups improved VO 2max , MetS z-score and QoL. VO 2max  (HIIT: + 3.1 mL/kg/min, p < 0.001; MIIT: + 1.2 mL/kg/min, p < 0.05) and MetS z-score (HIIT: - 1.8 units, p < 0.001; MIIT: - 1.2 units, p < 0.01) improved in an exercise intensity-dependent manner. In conclusion, extremely low-volume interval training, even when done at moderate intensity, is sufficiently effective to improve cardiometabolic health in obese MetS patients. These findings underpin the crucial role of exercise in the treatment of obesity and MetS.",2021,"All groups significantly reduced body weight (~ 3%) but only the exercise groups improved VO 2max , MetS z-score and QoL. VO 2max  (HIIT: + 3.1 mL/kg/min, p < 0.001; MIIT: + 1.2 mL/kg/min, p < 0.05) and MetS z-score (HIIT: - 1.8 units, p < 0.001; MIIT: - 1.2 units, p < 0.01) improved in an exercise intensity-dependent manner.","['obese metabolic syndrome patients', 'obese MetS patients', '117 patients (49.8\u2009±\u200913.6\xa0years, BMI: 38.2\u2009±\u20096.2\xa0kg/m 2 ']","['nutritional counseling to support weight loss', 'inactive control group', 'interval training (MIIT', 'very low volume high intensity versus moderate intensity interval training']","['cardiometabolic health', 'MetS z-score', 'body weight', 'VO 2max , MetS z-score and QoL. VO 2max', 'Maximal oxygen uptake (VO 2max ), MetS severity (MetS z-score), body composition and quality of life (QoL']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517820', 'cui_str': '6.2'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",117.0,0.0340021,"All groups significantly reduced body weight (~ 3%) but only the exercise groups improved VO 2max , MetS z-score and QoL. VO 2max  (HIIT: + 3.1 mL/kg/min, p < 0.001; MIIT: + 1.2 mL/kg/min, p < 0.05) and MetS z-score (HIIT: - 1.8 units, p < 0.001; MIIT: - 1.2 units, p < 0.01) improved in an exercise intensity-dependent manner.","[{'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Reljic', 'Affiliation': 'Hector-Center for Nutrition, Exercise and Sports, Department of Medicine 1, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg, Ulmenweg 18, 91054, Erlangen, Germany. dejan.reljic@uk-erlangen.de.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Frenk', 'Affiliation': 'Hector-Center for Nutrition, Exercise and Sports, Department of Medicine 1, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Herrmann', 'Affiliation': 'Hector-Center for Nutrition, Exercise and Sports, Department of Medicine 1, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Neurath', 'Affiliation': 'Department of Medicine 1, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Yurdagül', 'Initials': 'Y', 'LastName': 'Zopf', 'Affiliation': 'Hector-Center for Nutrition, Exercise and Sports, Department of Medicine 1, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg, Ulmenweg 18, 91054, Erlangen, Germany.'}]",Scientific reports,['10.1038/s41598-021-82372-4']
489,33560705,Effect of a Breathing Exercise on Respiratory Function and 6-Minute Walking Distance in Patients Under Hemodialysis: A Randomized Controlled Trial.,"BACKGROUND


Pulmonary disorders and poor functional capacity are common complications in patients under hemodialysis. Although breathing exercise is frequently prescribed to improve respiratory function, its efficacy in this patient community is not well established.
PURPOSE


Our study was designed to determine the effectiveness of a breathing exercise on respiratory function and 6-minute walk (6MW) distance in patients under hemodialysis.
METHODS


A randomized controlled trial approach was used. The sample consisted of 52 patients under hemodialysis from a university teaching hospital in Iran. The experimental group (n = 26) received the breathing exercise program and was encouraged to perform incentive spirometry for 2 months. The control group (n = 26) received only routine hospital care. The respiratory function test and 6MW test were performed at baseline and at 2 months after the intervention (posttest).
RESULTS


The two groups were homogeneous in terms of respiratory function parameters, 6MW distance, and demographic characteristics at baseline. Forced expiratory volume in 1 second and forced vital capacity were significantly better in the experimental group compared with the control group at 2 months after intervention. No significant difference was found in 6MW distance between the groups at the 2-month posttest.
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


The 2-month breathing exercise effectively improved pulmonary function parameters (forced vital capacity, forced expiratory volume in 1 second) in patients under hemodialysis but did not affect 6MW distance. Hemodialysis nurses should strengthen their clinical health education and apply breathing exercise programs to reduce the pulmonary complications experienced by patients under hemodialysis.",2021,"The 2-month breathing exercise effectively improved pulmonary function parameters (forced vital capacity, forced expiratory volume in 1 second) in patients under hemodialysis but did not affect 6MW distance.","['patients under hemodialysis', 'Patients Under Hemodialysis', '52 patients under hemodialysis from a university teaching hospital in Iran']","['routine hospital care', 'breathing exercise', 'Breathing Exercise', 'breathing exercise program and was encouraged to perform incentive spirometry for 2 months']","['pulmonary function parameters (forced vital capacity, forced expiratory volume in 1 second', 'respiratory function parameters, 6MW distance, and demographic characteristics', 'Forced expiratory volume in 1 second and forced vital capacity', '6MW distance', 'Respiratory Function and 6-Minute Walking Distance', 'respiratory function test and 6MW test', 'respiratory function and 6-minute walk (6MW) distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",52.0,0.0465135,"The 2-month breathing exercise effectively improved pulmonary function parameters (forced vital capacity, forced expiratory volume in 1 second) in patients under hemodialysis but did not affect 6MW distance.","[{'ForeName': 'Tajmohammad', 'Initials': 'T', 'LastName': 'Arazi', 'Affiliation': 'MSN, Nursing Educator, Department of Nursing and Operating Room, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Aliasgharpour', 'Affiliation': 'MSN, Nursing Educator, Faculty of Nursing and Midwifery, Department of Medical Surgical Nursing, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Mohammadi', 'Affiliation': 'PhD, Assistant Professor, Department of Nursing, Nursing Care Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Nooredin', 'Initials': 'N', 'LastName': 'Mohammadi', 'Affiliation': 'PhD, Associate Professor, Department of Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anoushirvan', 'Initials': 'A', 'LastName': 'Kazemnejad', 'Affiliation': 'PhD, Professor, Department of Biostatistics, School of Medicine, Tarbiat Modares University, Tehran, Iran.'}]",The journal of nursing research : JNR,['10.1097/JNR.0000000000000423']
490,33570656,WeChat-assisted dietary and exercise intervention for prevention of gestational diabetes mellitus in overweight/obese pregnant women: a two-arm randomized clinical trial.,"PURPOSE


This study aimed to examine the influence of a WeChat-based dietary and exercise intervention on gestational diabetes mellitus (GDM) prevention in overweight/obese pregnant women in Beijing.
METHODS


Overweight/obese pregnant women were recruited in the early stages of pregnancy. After screening by include and exclude standards, eligible women were randomly divided into two groups, intervention and control groups. The control group received a general advice session about pregnancy nutrition and weight management. The intervention group received three face-to-face sessions about personalized dietary and exercise intervention, with the help of WeChat as a monitoring tool to promote treatment plan adherence. At 24-28 weeks of pregnancy, GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria. Gestational weight gain (GWG), maternal and neonatal outcomes were also collected.
RESULTS


This study analyzed 215 participants. At the mid-trimester, 42 (37.8%) women in the control group were diagnosed with GDM (n = 111) versus 25 (24.5%) in the intervention group (n = 104; p < 0.05). The intervention group gained 11.2 ± 4.9 kg during the whole gestation period, with 4.9 ± 3.1 kg-weight increment in the first 25 weeks of pregnancy, versus 13.4 ± 5.0 kg and 6.9 ± 3.2 kg in the first 25 weeks in the control group (between groups: p < 0.001/p = 0.002). Incidence of macrosomia was not significantly lower in the intervention group than in the control group (8/7.9% vs 11/9.9%) (p > 0.05). No significant difference was found in the rate of natural labor and occurrence of perinatal complications (e.g., preterm birth, gestational hypertension, and preeclampsia) between the groups (p > 0.05).
CONCLUSIONS


The WeChat-assisted dietary and exercise intervention was effective in reducing the occurrence of GDM and excessive weight gain in overweight/obese pregnant women. Disseminating knowledge of pregnancy and childbirth through social media platforms like WeChat could be an important part of antenatal care.",2021,The WeChat-assisted dietary and exercise intervention was effective in reducing the occurrence of GDM and excessive weight gain in overweight/obese pregnant women.,"['overweight/obese pregnant women', '215 participants', 'gestational diabetes mellitus (GDM) prevention in overweight/obese pregnant women in Beijing', 'Overweight/obese pregnant women were recruited in the early stages of pregnancy', 'gestational diabetes mellitus in overweight/obese pregnant women']","['general advice session about pregnancy nutrition and weight management', 'WeChat-assisted dietary and exercise intervention', 'three face-to-face sessions about personalized dietary and exercise intervention', 'WeChat-based dietary and exercise intervention']","['Gestational weight gain (GWG', 'occurrence of GDM and excessive weight gain', 'maternal and neonatal outcomes', 'rate of natural labor and occurrence of perinatal complications (e.g., preterm birth, gestational hypertension, and preeclampsia', 'Incidence of macrosomia']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C1281996', 'cui_str': 'Early stage of pregnancy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0598901', 'cui_str': 'Prenatal Nutritional Physiological Phenomenon'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0000765', 'cui_str': 'Excessive weight gain'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}]",215.0,0.0531934,The WeChat-assisted dietary and exercise intervention was effective in reducing the occurrence of GDM and excessive weight gain in overweight/obese pregnant women.,"[{'ForeName': 'Bingjie', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Department of Clinical Nutrition, Beijing Friendship Hospital, Capital Medical University, Beijing, 10050, China.'}, {'ForeName': 'Baohua', 'Initials': 'B', 'LastName': 'Gou', 'Affiliation': ""Department of Gynecology and Obstetrics, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 10050, People's Republic of China.""}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Guan', 'Affiliation': ""Department of Gynecology and Obstetrics, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 10050, People's Republic of China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Nutrition, Beijing Friendship Hospital, Capital Medical University, Beijing, 10050, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Clinical Nutrition, Beijing Friendship Hospital, Capital Medical University, Beijing, 10050, China.'}, {'ForeName': 'Zhongxin', 'Initials': 'Z', 'LastName': 'Hong', 'Affiliation': 'Department of Clinical Nutrition, Beijing Friendship Hospital, Capital Medical University, Beijing, 10050, China. hongzhongxin@vip.sina.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-021-05984-1']
491,33222689,Do nuclear magnetic resonance (NMR)-based metabolomics improve the prediction of pregnancy-related disorders? Findings from a UK birth cohort with independent validation.,"BACKGROUND


Prediction of pregnancy-related disorders is usually done based on established and easily measured risk factors. Recent advances in metabolomics may provide earlier and more accurate prediction of women at risk of pregnancy-related disorders.
METHODS


We used data collected from women in the Born in Bradford (BiB; n = 8212) and UK Pregnancies Better Eating and Activity Trial (UPBEAT; n = 859) studies to create and validate prediction models for pregnancy-related disorders. These were gestational diabetes mellitus (GDM), hypertensive disorders of pregnancy (HDP), small for gestational age (SGA), large for gestational age (LGA) and preterm birth (PTB). We used ten-fold cross-validation and penalised regression to create prediction models. We compared the predictive performance of (1) risk factors (maternal age, pregnancy smoking, body mass index (BMI), ethnicity and parity) to (2) nuclear magnetic resonance-derived metabolites (N = 156 quantified metabolites, collected at 24-28 weeks gestation) and (3) combined risk factors and metabolites. The multi-ethnic BiB cohort was used for training and testing the models, with independent validation conducted in UPBEAT, a multi-ethnic study of obese pregnant women.
RESULTS


Maternal age, pregnancy smoking, BMI, ethnicity and parity were retained in the combined risk factor and metabolite models for all outcomes apart from PTB, which did not include maternal age. In addition, 147, 33, 96, 51 and 14 of the 156 metabolite traits were retained in the combined risk factor and metabolite model for GDM, HDP, SGA, LGA and PTB, respectively. These include cholesterol and triglycerides in very low-density lipoproteins (VLDL) in the models predicting GDM, HDP, SGA and LGA, and monounsaturated fatty acids (MUFA), ratios of MUFA to omega 3 fatty acids and total fatty acids, and a ratio of apolipoprotein B to apolipoprotein A-1 (APOA:APOB1) were retained predictors for GDM and LGA. In BiB, discrimination for GDM, HDP, LGA and SGA was improved in the combined risk factors and metabolites models. Risk factor area under the curve (AUC 95% confidence interval (CI)): GDM (0.69 (0.64, 0.73)), HDP (0.74 (0.70, 0.78)) and LGA (0.71 (0.66, 0.75)), and SGA (0.59 (0.56, 0.63)). Combined risk factor and metabolite models AUC 95% (CI): GDM (0.78 (0.74, 0.81)), HDP (0.76 (0.73, 0.79)) and LGA (0.75 (0.70, 0.79)), and SGA (0.66 (0.63, 0.70)). For GDM, HDP and LGA, but not SGA, calibration was good for a combined risk factor and metabolite model. Prediction of PTB was poor for all models. Independent validation in UPBEAT at 24-28 weeks and 15-18 weeks gestation confirmed similar patterns of results, but AUCs were attenuated.
CONCLUSIONS


Our results suggest a combined risk factor and metabolite model improves prediction of GDM, HDP and LGA, and SGA, when compared to risk factors alone. They also highlight the difficulty of predicting PTB, with all models performing poorly.",2020,"For GDM, HDP and LGA, but not SGA, calibration was good for a combined risk factor and metabolite model.","['obese pregnant women', 'women in the Born in Bradford (BiB; n\u2009=\u20098212) and UK Pregnancies Better Eating and Activity Trial (UPBEAT; n\u2009=\u2009859) studies to create and validate prediction models for pregnancy-related disorders', 'These were gestational diabetes mellitus (GDM), hypertensive disorders of pregnancy (HDP), small for gestational age (SGA), large for gestational age (LGA) and preterm birth (PTB']","['nuclear magnetic resonance (NMR)-based metabolomics', 'apolipoprotein A-1 (APOA:APOB1', 'Combined risk factor and metabolite models']","['HDP', 'BiB, discrimination for GDM, HDP, LGA and SGA', 'predictive performance of (1) risk factors (maternal age, pregnancy smoking, body mass index (BMI), ethnicity and parity', 'LGA', 'prediction of GDM, HDP and LGA, and SGA', 'cholesterol and triglycerides', 'GDM']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0003592', 'cui_str': 'Apolipoprotein A'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.0394184,"For GDM, HDP and LGA, but not SGA, calibration was good for a combined risk factor and metabolite model.","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'McBride', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK. nancy.mcbride@bristol.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yousefi', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'White', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Farrar', 'Affiliation': 'Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'NIHR Bristol Biomedical Research Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Nelson', 'Affiliation': 'NIHR Bristol Biomedical Research Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Mason', 'Affiliation': 'Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Suderman', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Relton', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Lawlor', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}]",BMC medicine,['10.1186/s12916-020-01819-z']
492,33574495,Second generation laryngeal mask airway during laparoscopic living liver donor hepatectomy: a randomized controlled trial.,"The second-generation laryngeal mask airway (LMA) provides a higher sealing pressure than classical LMA and can insert the gastric drainage tube. We investigated the difference in respiratory variables according to the use of second-generation LMA and endotracheal tube (ETT) in laparoscopic living liver donor hepatectomy (LLDH). In this single-blind randomized controlled trial, intraoperative arterial carbon dioxide partial pressure at 2 h after the airway devices insertion (P a CO 2_ 2h) was compared as a primary outcome. Participants were randomly assigned to the following groups: Group LMA (n = 45, used Protector LMA), or Group ETT (n = 43, used cuffed ETT). Intraoperative hemodynamic and respiratory variables including mean blood pressure (MBP), heart rate (HR), and peak inspiratory pressure (PIP) were compared. Postoperative sore throat, hoarseness, postoperative nausea and vomiting (PONV), and pulmonary aspiration were recorded. The P a CO 2_ 2h were equally effective between two groups (mean difference: 0.99 mmHg, P = 0.003; 90% confidence limits: - 0.22, 2.19). The intraoperative change in MBP, HR, and PIP were differed over time between two groups (P < 0.001, P = 0.015, and P = 0.039, respectively). There were no differences of the incidence of postoperative complications at 24 h following LLDH (sore throat and hoarseness: P > 0.99, PONV: P > 0.99, and P = 0.65, respectively). No case showed pulmonary aspiration in both groups. Compared with endotracheal tube, second-generation LMA is equally efficient during LLDH. The second-generation LMA can be considered as the effective airway devices for securing airway in patients undergoing prolonged laparoscopic surgery. Trial Registration This study was registered at the Clinical Trial Registry of Korea ( https://cris.nih.go.kr . CRiS No. KCT0003711).",2021,"There were no differences of the incidence of postoperative complications at 24 h following LLDH (sore throat and hoarseness: P > 0.99, PONV: P > 0.99, and P = 0.65, respectively).","['patients undergoing prolonged laparoscopic surgery', 'laparoscopic living liver donor hepatectomy (LLDH']","['endotracheal tube, second-generation LMA', 'intraoperative arterial carbon dioxide partial pressure', 'second-generation LMA and endotracheal tube (ETT', 'Group LMA (n\u2009=\u200945, used Protector LMA), or Group ETT (n\u2009=\u200943, used cuffed ETT', 'Second generation laryngeal mask airway during laparoscopic living liver donor hepatectomy', 'second-generation laryngeal mask airway (LMA']","['incidence of postoperative complications', 'mean blood pressure (MBP), heart rate (HR), and peak inspiratory pressure (PIP', 'pulmonary aspiration', 'intraoperative change in MBP, HR, and PIP', 'Postoperative sore throat, hoarseness, postoperative nausea and vomiting (PONV), and pulmonary aspiration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0391839', 'cui_str': 'PCO2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0700198', 'cui_str': 'Pulmonary aspiration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",,0.179125,"There were no differences of the incidence of postoperative complications at 24 h following LLDH (sore throat and hoarseness: P > 0.99, PONV: P > 0.99, and P = 0.65, respectively).","[{'ForeName': 'Doyeon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Sukhee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, International St. Mary's Hospital, Catholic Kwandong University School of Medicine, Incheon, Republic of Korea.""}, {'ForeName': 'Jong Man', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Gyu Seong', 'Initials': 'GS', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Gaab Soo', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea. gskim@skku.edu.'}]",Scientific reports,['10.1038/s41598-021-83173-5']
493,33574421,"Impact of synbiotics on gut microbiota during early life: a randomized, double-blind study.","Human milk is considered the optimal nutrition for infants and found to contain significant numbers of viable bacteria. The aim of the study was to assess the effects of a specific synbiotic combination at doses closer to the bacterial cells present in human milk, on intestinal bifidobacteria proportions (relative abundance), reduction of potential pathogens and gut physiological conditions. A clinical study was conducted in 290 healthy infants aged from 6 to 19 weeks. Infants received either a control infant formula or one of the two investigational infant formulas (control formula with 0.8 g/100 ml scGOS/lcFOS and Bifidobacterium breve M-16V at either 1 × 10 4  cfu/ml or 1 × 10 6  cfu/ml). Exclusively breastfed infants were included as a reference. Analyses were performed on intention-to-treat groups and all-subjects-treated groups. After 6 weeks of intervention, the synbiotics at two different doses significantly increased the bifidobacteria proportions in healthy infants. The synbiotic supplementation also decreased the prevalence (infants with detectable levels) and the abundance of C. difficile. Closer to the levels in the breastfed reference group, fecal pH was significantly lower while L-lactate concentrations and acetate proportions were significantly higher in the synbiotic groups. All formulas were well tolerated and all groups showed a comparable safety profile based on the number and severity of adverse events and growth. In healthy infants, supplementation of infant-type bifidobacterial strain B. breve M-16V, at a dose close to bacterial numbers found in human milk, with scGOS/lcFOS (9:1) created a gut environment closer to the breastfed reference group. This specific synbiotic mixture may also support gut microbiota resilience during early life.Clinical Trial Registration This clinical study named Color Synbiotics Study, was registered in ClinicalTrials.gov on 18 March 2013. Registration number is NCT01813175. https://clinicaltrials.gov/ct2/show/NCT01813175 .",2021,"Closer to the levels in the breastfed reference group, fecal pH was significantly lower while L-lactate concentrations and acetate proportions were significantly higher in the synbiotic groups.","['gut microbiota during early life', 'healthy infants', '290 healthy infants aged from 6 to 19\xa0weeks']","['control infant formula or one of the two investigational infant formulas (control formula with 0.8\xa0g/100\xa0ml scGOS/lcFOS and Bifidobacterium breve M-16V', 'specific synbiotic combination', 'synbiotic supplementation']","['L-lactate concentrations and acetate proportions', 'number and severity of adverse events and growth', 'bifidobacteria proportions', 'abundance of C. difficile', 'fecal pH']","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1881354', 'cui_str': 'L-lactate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0474572', 'cui_str': 'Measurement of feces pH'}]",290.0,0.0803154,"Closer to the levels in the breastfed reference group, fecal pH was significantly lower while L-lactate concentrations and acetate proportions were significantly higher in the synbiotic groups.","[{'ForeName': 'Nopaorn', 'Initials': 'N', 'LastName': 'Phavichitr', 'Affiliation': 'Department of Paediatrics, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Shugui', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Danone Nutricia Research, Singapore, Singapore.'}, {'ForeName': 'Sirinuch', 'Initials': 'S', 'LastName': 'Chomto', 'Affiliation': 'Nutritional Unit, Department of Pediatrics, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ruangvith', 'Initials': 'R', 'LastName': 'Tantibhaedhyangkul', 'Affiliation': 'Department of Paediatrics, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Kakourou', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands.'}, {'ForeName': 'Sukkrawan', 'Initials': 'S', 'LastName': 'Intarakhao', 'Affiliation': 'Department of Pediatrics, Thammasat Hospital, Faculty of Medicine, Thammasat University, Bangkok, Thailand.'}, {'ForeName': 'Sungkom', 'Initials': 'S', 'LastName': 'Jongpiputvanich', 'Affiliation': 'Department of Pediatrics, Thammasat Hospital, Faculty of Medicine, Thammasat University, Bangkok, Thailand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Guus', 'Initials': 'G', 'LastName': 'Roeselers', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands. guus.roeselers@danone.com.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Knol', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands.'}]",Scientific reports,['10.1038/s41598-021-83009-2']
494,33564017,Effect of tamoxifen with or without gonadotropin-releasing hormone analog on DXA values in women with breast cancer.,"The purpose of this study was to compare the changes in DXA values including trabecular bone score (TBS) and bone mineral density (BMD) of lumbar spine (LS) and femur according to the hormone therapies including tamoxifen (TMXF) treatment with or without gonadotropin releasing hormone analog (GnRH analog) in women with breast cancer. We enrolled 119 women with breast cancer who had undergone breast-conserving surgery or mastectomy followed by TMXF treatment for postmenopausal women (TMXF group, n = 63, 52.9%) or by combination therapy of TMXF combined with GnRH analog for premenopausal women (TMXF + GnRH group, n = 56, 47.1%) from December 2013 to December 2017. The median follow-up period was 13 months (interquartile range [IQR], 12.0-14.75) for TMXF group and 13.5 months (IQR, 12.00-16.00) for TMXF + GnRH group, respectively. Patients did not receive bone-modifying therapy. The baseline dual-energy X-ray absorptiometry (DXA) scan before breast cancer surgery and follow-up DXA during hormone therapy. Comparing the first and follow-up DXA results, BMD in LS were significantly decreased in both TMXF (P < 0.001, mean difference: - 0.06) and TMXF + GnRH (P < 0.001, mean difference: - 0.09) groups. BMD values of femoral neck (P = 0.0011, mean difference: - 0.01) and total femur (P < 0.001, mean difference: - 0.03) was significantly changed between the baseline and follow-up DXA in TMXF + RnRH group. In the TMX group, a significant changed occurred in the BMD in total femur (P < 0.001, mean difference: - 0.030) but not the BMD of femoral neck (P = 0.095, mean difference: - 0.007). Regarding TBS, no significant change was found in the TMXF (P = 0.574, mean difference: - 0.004) group, whereas there was a significant decrease in TBS in the TMXF + GnRH (P < 0.001, mean difference: - 0.02) group during follow-up. TBS is more sensitive in reflecting the bone microarchitecture changes by TMXF or GnRH agonist in breast cancer patients than BMD. This finding demonstrates that TBS can be a useful parameter to detect bone microarchitectural changes in clinical applications.",2021,"In the TMX group, a significant changed occurred in the BMD in total femur (P < 0.001, mean difference: - 0.030) but not the BMD of femoral neck (P = 0.095, mean difference: - 0.007).","['119 women with breast cancer who had undergone breast-conserving surgery or mastectomy followed by TMXF treatment for postmenopausal women (TMXF group, n\u2009=\u200963, 52.9%) or by combination therapy of TMXF combined with GnRH analog for premenopausal women (TMXF\u2009+\u2009GnRH group, n\u2009=\u200956, 47.1%) from December 2013 to December 2017', 'breast cancer patients than BMD', 'women with breast cancer']","['TBS', 'tamoxifen with or without gonadotropin-releasing hormone analog', 'TMX', 'TMXF', 'tamoxifen (TMXF) treatment with or without gonadotropin releasing hormone analog (GnRH analog']","['DXA values', 'total femur', 'BMD values of femoral neck', 'TMXF', 'TBS', 'BMD of femoral neck', 'BMD in LS', 'trabecular bone score (TBS) and bone mineral density (BMD) of lumbar spine (LS', 'BMD in total femur']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",119.0,0.0326028,"In the TMX group, a significant changed occurred in the BMD in total femur (P < 0.001, mean difference: - 0.030) but not the BMD of femoral neck (P = 0.095, mean difference: - 0.007).","[{'ForeName': 'Eun Heui', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Yun Kyung', 'Initials': 'YK', 'LastName': 'Jeon', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Kyoungjune', 'Initials': 'K', 'LastName': 'Pak', 'Affiliation': 'Department of Nuclear Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Taewoo', 'Initials': 'T', 'LastName': 'Kang', 'Affiliation': 'Busan Cancer Center (Breast Cancer Clinic) and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Kyung-Eun', 'Initials': 'KE', 'LastName': 'Kim', 'Affiliation': 'Busan Cancer Center (Breast Cancer Clinic) and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Seong-Jang', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine and Research Institute for Convergence of Biomedical Science and Technology, Yangsan Pusan National University Hospital, Yangsan, Republic of Korea.'}, {'ForeName': 'In-Joo', 'Initials': 'IJ', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Keunyoung', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea. nmpnuh@gmail.com.'}]",Scientific reports,['10.1038/s41598-021-82824-x']
495,33565359,Urodynamics in patients with multiple sclerosis: is it necessary? A randomized-controlled trial.,"BACKGROUND


The need for complete urodynamic evaluation in Multiple Sclerosis (MS) patients with Lower Urinary Tract Symptoms (LUTS) is not fully established in the literature. The objective was to evaluate the effect of urodynamics in MS patients with LUTS on treatment outcomes.
METHODS


MS patients with LUTS were recruited. On their first visit, urinary symptoms, symptom bother and urologic quality-of-life were evaluated using standardized questionnaires. On their second visit, patients were randomized into two groups: Group A underwent uroflowmetry, and Group B underwent a urodynamic study. Patients received treatment based on the whole evaluation and then were evaluated at 1, 3 and 6 months.
RESULTS


Fifty MS patients with LUTS were randomized to 25 patients in each group. All scores decreased significantly after 6 months of treatment in both groups ( p  < 0.05). However, no differences were found between the two groups at baseline and at 1, 3 and 6 months of treatment ( p  > 0.05) concerning treatment outcomes.
CONCLUSION


A detailed clinical and non-invasive evaluation of MS patients with LUTS seems to be sufficient for prescribing an effective treatment. A urodynamic study does not influence the response to the prescribed treatment in terms of LUTS severity, bother or urologic quality-of-life.",2021,All scores decreased significantly after 6 months of treatment in both groups ( p  < 0.05).,"['MS patients with LUTS were recruited', 'MS patients with', 'Fifty MS patients with LUTS', 'patients with multiple sclerosis', 'Multiple Sclerosis (MS) patients with Lower Urinary Tract Symptoms (LUTS']",['LUTS'],"['LUTS severity, bother or urologic quality-of-life', 'urinary symptoms, symptom bother and urologic quality-of-life']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",50.0,0.0323888,All scores decreased significantly after 6 months of treatment in both groups ( p  < 0.05).,"[{'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'El Helou', 'Affiliation': 'Department of Urology, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Sarkis', 'Affiliation': 'Department of Urology, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Mjaess', 'Affiliation': 'Faculty of Medicine, Saint, Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Jad', 'Initials': 'J', 'LastName': 'Zalaket', 'Affiliation': 'Faculty of Medicine, Saint, Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mouawad', 'Affiliation': 'Faculty of Medicine, Saint, Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Sayegh', 'Affiliation': 'Faculty of Medicine, Saint, Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Souad', 'Initials': 'S', 'LastName': 'Ghattas', 'Affiliation': 'Faculty of Medicine, Saint, Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Azar', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'El Helou', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Halim', 'Initials': 'H', 'LastName': 'Abboud', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Salam', 'Initials': 'S', 'LastName': 'Koussa', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Nemr', 'Affiliation': 'Department of Urology, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon.'}]",Scandinavian journal of urology,['10.1080/21681805.2021.1879930']
496,33565308,Steroid resistant focal segmental glomerulosclerosis: effect of arterial hyalinosis on outcome: single center study.,"Background.  Few data with adequate evidence exists as regards the effect of Cyclosporine (CsA) and mycophenolate mofetil (MMF) on pathological prognostic parameters in patients with steroid resistant focal segmental glomerulosclerosis (FSGS). The purpose of the present study is to compare the effect of cyclosporin and mycophenolate mofetil in addition to steroids on functional and histopathologic renal parameters in patients with steroid resistant FSGS one year after treatment. Material and methods.  Thirty-seven adults with primary FSGS patients resistant to steroid therapy consecutively randomized to treatment with either MMF or cyclosporine. Low dose prednisolone added to both groups. Glomerular filtration rate (GFR) and blood pressure (BP) were determined at all examinations and a second renal biopsy was taken 12 months after treatment with either of cyclosporin and mycophenolate mofetil. Results.  GFR significantly increased in MMF group p < 0.01 after 6 months and unchanged after 12 months. On the other hand, GFR significantly decrease in CsA group p < 0.001 after 6 months and reduced more after 12 months p < 0.001 compared to base line levels. There was a significant difference of GFR between the 2 groups at 6 months p < 0.001. The extent of proteinuria decreased significantly in CsA group after 12 months p < 0.001. The extent of arteriolar hyalinosis increased significantly in CsA group (0.78 to 1.81 score, p < 0.001) but was unchanged in MMF group (0.93 to 0.96 score), whereas interstitial fibrosis increased to same level in both groups (grade 3). Conclusion.  Conversion to MMF in those patients may be superior to CsA as regards GFR after 12 months after treatment in spite of the presence of greater level of protein excretion. The increased arteriolar hyalinosis during CsA treatment most likely results in higher BP compared to MMF treatment in patients with FSGS resistant to steroids.",2021,"The extent of arteriolar hyalinosis increased significantly in CsA group (0.78 to 1.81 score, p <0.001) but was unchanged in MMF group (0.93 to 0.96 score), whereas interstitial fibrosis increased to same level in both groups (grade 3).","['patients with steroid resistant FSGS one year after treatment', 'Material and methods : Thirty-seven adults with primary FSGS patients resistant to steroid therapy consecutively randomized to treatment with either', 'Outcome', 'patients with steroid resistant focal segmental glomerulosclerosis (FSGS']","['cyclosporin and mycophenolate mofetil', 'MMF or cyclosporine', 'MMF', 'prednisolone', 'Cyclosporine (CsA) and mycophenolate mofetil (MMF']","['arteriolar hyalinosis', 'GFR', 'functional and histopathologic renal parameters', 'Glomerular filtration rate (GFR) and blood pressure (BP', 'interstitial fibrosis', 'extent of proteinuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0017668', 'cui_str': 'Focal glomerular sclerosis'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0442833', 'cui_str': 'Arteriolar hyalinosis'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0677043', 'cui_str': 'Histopathology'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3887486', 'cui_str': 'Interstitial fibrosis'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",37.0,0.0393779,"The extent of arteriolar hyalinosis increased significantly in CsA group (0.78 to 1.81 score, p <0.001) but was unchanged in MMF group (0.93 to 0.96 score), whereas interstitial fibrosis increased to same level in both groups (grade 3).","[{'ForeName': 'Amin R', 'Initials': 'AR', 'LastName': 'Soliman', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Maamoun', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Haytham', 'Initials': 'H', 'LastName': 'Soliman', 'Affiliation': 'House officer, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Rabab Mahmoud', 'Initials': 'RM', 'LastName': 'Ahmed', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Romanian journal of internal medicine = Revue roumaine de medecine interne,['10.2478/rjim-2020-0045']
497,33565303,Effects of an actual insulin injection demonstration on insulin acceptance among patients with T2DM: a pragmatic randomized controlled trial.,"Introduction.  Insulin injection refusal is a challenge when initiating insulin therapy. This study aimed to investigate the effects of an actual insulin injection demonstration on insulin acceptance in patients with type 2 diabetes mellitus (T2DM). Methods.  A pragmatic randomised controlled trial (RCT) was conducted. The participants were patients with T2DM aged 18-65 years old. The control group (CG) received an educational programme regarding T2DM. The intervention group (IG) received the educational programme and actual insulin injection demonstration (a physician-led sample insulin injection using an insulin pen). The main outcome was immediate insulin acceptance. Insulin adherence, glycated haemoglobin (HbA1c), and adverse effects of insulin were evaluated at three months after the intervention. Results.  Forty-nine participants with T2DM were allocated to the IG (n = 24) and the CG (n = 25). The immediate insulin acceptance was significantly higher in the IG (79.17%, n = 19) than the CG (24.00%, n = 6; p < 0.05; RR 3.30, 95% CI 1.59 to 6.82). At the three-month follow-up, the insulin adherence was significantly different between the two groups (IG: 75.00%, n = 18 vs CG: 20.00%, n = 5; p < 0.05; RR 3.75, 95% CI 1.66 to 8.49). Adverse effects of insulin, HbA1c levels, and changes in HbA1c levels between the IG and CG were not different. Conclusion.  The physician-led actual insulin injection demonstration is effective for increasing insulin acceptance among participants with T2DM.",2021,"The immediate insulin acceptance was significantly higher in the IG (79.17%, n=19) than the CG (24.00%, n=6; p---lt---0.05; RR 3.30, 95%CI 1.59 to 6.82).","['patients with T2DM', 'Forty-nine participants with T2DM', 'participants with T2DM', 'participants were patients with T2DM aged 18-65 years old', 'patients with type 2 diabetes mellitus (T2DM']","['educational programme and actual insulin injection demonstration (a physician-led sample insulin injection using an insulin pen', 'actual insulin injection demonstration', 'CG', 'educational programme regarding T2DM']","['Adverse effects of insulin, HbA1c levels, and changes in HbA1c levels', 'insulin adherence', 'Insulin adherence, glycated haemoglobin (HbA1c), and adverse effects of insulin', 'insulin acceptance', 'immediate insulin acceptance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0413591', 'cui_str': 'Insulin adverse reaction'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",49.0,0.159974,"The immediate insulin acceptance was significantly higher in the IG (79.17%, n=19) than the CG (24.00%, n=6; p---lt---0.05; RR 3.30, 95%CI 1.59 to 6.82).","[{'ForeName': 'Atthayaporn', 'Initials': 'A', 'LastName': 'Choomai', 'Affiliation': 'Thasala Hospital, Thasala, Nakhon Si Thammarat, Thailand.'}, {'ForeName': 'Apichai', 'Initials': 'A', 'LastName': 'Wattanapisit', 'Affiliation': 'School of Medicine, Walailak University, Thasala, Nakhon Si Thammarat, Thailand.'}, {'ForeName': 'Orathai', 'Initials': 'O', 'LastName': 'Tiangtam', 'Affiliation': 'Thasala Hospital, Thasala, Nakhon Si Thammarat, Thailand.'}]",Romanian journal of internal medicine = Revue roumaine de medecine interne,['10.2478/rjim-2020-0040']
498,33580174,Effectiveness of e-Health cardiac rehabilitation program on quality of life associated with symptoms of anxiety and depression in moderate-risk patients.,"Exploring new models of medical care requires evaluating the impact of new care strategies not only on physiological parameters but also on the quality of life of the patient. On the other hand the presence of anxiety together with depression requires further consideration when planning appropriate management strategies. The aim of this study was to examine the effectiveness of a home-based cardiac rehabilitation program incorporating an e-Health technology on health-related quality of life associated with symptoms of anxiety and depression in moderate-risk patients. A multicenter, randomized controlled clinical trial was designed to compare a traditional hospital based cardiac rehabilitation program (n = 38, 35 male) with a mixed home surveillance program where patients exercised at home with a remote electrocardiographic monitoring device (n = 33, 31 male). The Short Form-36 (SF-36) Health Survey and the Goldberg questionnaire were used to evaluate quality of life and the presence of symptoms of anxiety and depression respectively. The results of this study show that the type of cardiac rehabilitation program did not influence the improvement in quality of life (p = 0.854), but the presence of symptoms of anxiety and depression did (p = 0.001). Although both programs achieved a decrease in anxiety and depression symptoms and improved functional capacity (p ≤ 0.001), a significant interaction effect was found between the group with or without anxiety and depression symptoms and the type of program in the bodily pain dimension (p = 0.021). Trial registration: Retrospectively registered NCT02796404 (10/06/2016) in clinialtrials.gov.",2021,"Although both programs achieved a decrease in anxiety and depression symptoms and improved functional capacity (p ≤ 0.001), a significant interaction effect was found between the group with or without anxiety and depression symptoms and the type of program in the bodily pain dimension (p = 0.021).","['n\u2009=\u200933, 31 male', 'moderate-risk patients', 'n\u2009=\u200938, 35 male) with a']","['e-Health cardiac rehabilitation program', 'mixed home surveillance program where patients exercised at home with a remote electrocardiographic monitoring device', 'home-based cardiac rehabilitation program', 'traditional hospital based cardiac rehabilitation program']","['bodily pain dimension', 'quality of life and the presence of symptoms of anxiety and depression respectively', 'presence of symptoms of anxiety and depression', 'quality of life', 'anxiety and depression symptoms and improved functional capacity', 'quality of life associated with symptoms of anxiety and depression']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1444530', 'cui_str': 'Housing surveillance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0180580', 'cui_str': 'Electrocardiographic monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",,0.0318719,"Although both programs achieved a decrease in anxiety and depression symptoms and improved functional capacity (p ≤ 0.001), a significant interaction effect was found between the group with or without anxiety and depression symptoms and the type of program in the bodily pain dimension (p = 0.021).","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Bravo-Escobar', 'Affiliation': 'Cardiac Rehabilitation Unit, Virgen de La Victoria University Hospital of Malaga, Campus de Teatinos s/n, 29010, Malaga, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'González-Represas', 'Affiliation': 'Department of Functional Biology and Health Sciences, Physical Therapy Faculty, University of Vigo, Campus A Xunqueira s/n, 36005, Pontevedra, Spain. alicia@uvigo.es.'}, {'ForeName': 'Adela María', 'Initials': 'AM', 'LastName': 'Gómez-González', 'Affiliation': 'Cardiac Rehabilitation Unit, Virgen de La Victoria University Hospital of Malaga, Campus de Teatinos s/n, 29010, Malaga, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Heredia-Torres', 'Affiliation': 'Cardiac Rehabilitation Unit, Reina Sofía University Hospital of Córdoba, Avda. Menéndez Pidal, s/n, 14004, Córdoba, Spain.'}]",Scientific reports,['10.1038/s41598-021-83231-y']
499,33580103,"Multiple micronutrient supplementation improves micronutrient status in primary school children in Hai Phong City, Vietnam: a randomised controlled trial.","We aimed to determine the efficacy of multiple micronutrient supplementation on the biomarkers of iron, zinc, and vitamin A status across anthropometric status categories in Vietnamese school children. In this 22-week randomised controlled trial, 347 undernourished, normal weight, or overweight/obese children aged 6-9 years were allocated to receive every school day a multiple micronutrient supplement (10 mg iron, 10 mg zinc, 400 µg vitamin A) or a placebo. Haematological indices; circulating ferritin, zinc, and retinol (corrected for inflammation); and C-reactive protein were measured at baseline and 22 weeks. At week 22, linear mixed models showed that mean corpuscular volume increased by 0.3 fL, serum ferritin by 9.1 µg/L, plasma zinc by 0.9 µmol/L, and plasma retinol by 15%, and the prevalence of zinc deficiency decreased by 17.3% points in the intervention group compared to placebo. No intervention effects were found for other haematological indices, or the prevalence of anaemia. Multiple micronutrient supplementation for 22 weeks improved the biomarkers of zinc and vitamin A status and some biomarkers of iron status, and reduced the prevalence of zinc deficiency in Vietnamese school children.Trial registration: This trial was registered on 06/09/2016 at www.anzctr.org.au as ACTRN12616001245482.",2021,"Multiple micronutrient supplementation for 22 weeks improved the biomarkers of zinc and vitamin A status and some biomarkers of iron status, and reduced the prevalence of zinc deficiency in Vietnamese school children.","['347 undernourished, normal weight, or overweight/obese children aged 6-9\xa0years', 'Vietnamese school children', 'primary school children in Hai Phong City, Vietnam']","['placebo', 'multiple micronutrient supplement (10\xa0mg iron, 10\xa0mg zinc, 400\xa0µg vitamin A) or a placebo', 'Multiple micronutrient supplementation', 'multiple micronutrient supplementation']","['prevalence of zinc deficiency', 'biomarkers of zinc and vitamin A status and some biomarkers of iron status', 'micronutrient status', 'plasma zinc', 'biomarkers of iron, zinc, and vitamin A status across anthropometric status categories', 'plasma retinol', 'prevalence of anaemia', 'mean corpuscular volume', 'Haematological indices; circulating ferritin, zinc, and retinol (corrected for inflammation); and C-reactive protein', 'serum ferritin']","[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0205721', 'cui_str': 'Nosocomial infection'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0524587', 'cui_str': 'Mean cell volume - finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}]",347.0,0.354741,"Multiple micronutrient supplementation for 22 weeks improved the biomarkers of zinc and vitamin A status and some biomarkers of iron status, and reduced the prevalence of zinc deficiency in Vietnamese school children.","[{'ForeName': 'Ngan T D', 'Initials': 'NTD', 'LastName': 'Hoang', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Orellana', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, Australia.'}, {'ForeName': 'Rosalind S', 'Initials': 'RS', 'LastName': 'Gibson', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tuyen D', 'Initials': 'TD', 'LastName': 'Le', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Worsley', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Faculty of Health, Deakin University, Geelong, Australia.'}, {'ForeName': 'Nghien T T', 'Initials': 'NTT', 'LastName': 'Hoang', 'Affiliation': 'Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Ewa A', 'Initials': 'EA', 'LastName': 'Szymlek-Gay', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia. ewa.szymlekgay@deakin.edu.au.'}]",Scientific reports,['10.1038/s41598-021-83129-9']
500,33566703,Evaluation of a new cemented highly cross-linked all-polyethylene cup: a prospective and randomised study assessing wear and fixation characteristics using radiostereometric analysis.,"BACKGROUND AND PURPOSE


The aim of this prospective, randomised and controlled study was to evaluate the wear and fixation properties of a new cemented highly cross-linked all-polyethylene (HXLPE) cup in comparison with a conventional cemented ultra-high molecular weight polyethylene (ConvPE) cup using radiostereometric analysis (RSA).
PATIENTS AND METHODS


A total of 58 patients (58 hips) with primary osteoarthritis (OA) were enrolled in a randomised controlled trial to receive either a ConvPE cup (control) or HXLPE cup (intervention) with identical geometry. The subjects were randomised in a 1:1 ratio. The primary endpoint was proximal wear measured as femoral head penetration into the cup, secondary outcomes were 3D-wear and annual proximal wear from 1 to 5 years. Cup fixation was measured as movement of the cup in relation to the acetabular bone with proximal migration being the primary outcome measure, 3D-migration and change in inclination as secondary outcomes. The patients were followed for 5 years with RSA performed postoperatively, at 3, 12, 24, and 60 months.
RESULTS


The HXLPE displayed a lower median proximal femoral head penetration compared to ConvPE, with a median difference at 2 years of -0.07 mm (95% CI, -0.10 to -0.04 mm), and -0.19 mm (95% CI, -0.27 to -0.15 mm) at 5 years. Annual proximal wear between 1 and 5 years was 0.03 mm/year for HXLPE and 0.06 mm/year for ConvPE (mean difference 0.05 mm, [95% CI, 0.03-0.07 mm]). Proximal migration, 3D migration and change in inclination was numerically slightly higher for HXLPE, albeit not statistically significant.
CONCLUSIONS


Compared to ConvPE, the HXLPE cup displayed significantly lower polyethylene wear. Cup migration was not statistically significant different.
CLINICALTRIALS.GOV IDENTIFIER


NCT04322799.",2021,"Proximal migration, 3D migration and change in inclination was numerically slightly higher for HXLPE, albeit not statistically significant.
",['58 patients (58 hips) with primary osteoarthritis (OA'],"['HXLPE', 'new cemented highly cross-linked all-polyethylene cup', 'ConvPE', 'ConvPE cup (control) or HXLPE cup (intervention) with identical geometry', 'new cemented highly cross-linked all-polyethylene (HXLPE) cup', 'conventional cemented ultra-high molecular weight polyethylene (ConvPE) cup using radiostereometric analysis (RSA']","['Cup fixation', 'proximal wear measured as femoral head penetration into the cup, secondary outcomes were 3D-wear and annual proximal wear from 1 to 5\u2009years', 'Proximal migration, 3D migration and change in inclination', 'median proximal femoral head penetration', 'Cup migration', 'wear and fixation properties', 'Annual proximal wear']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0673477', 'cui_str': 'ultra-high molecular weight polyethylene'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}]","[{'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",58.0,0.228112,"Proximal migration, 3D migration and change in inclination was numerically slightly higher for HXLPE, albeit not statistically significant.
","[{'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Otten', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Orthopaedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wästerlund', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Orthopaedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lindbjörn', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Orthopaedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Mertens', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Orthopaedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mukka', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Orthopaedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sead', 'Initials': 'S', 'LastName': 'Crnalic', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Orthopaedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Kjell G', 'Initials': 'KG', 'LastName': 'Nilsson', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Orthopaedics, Umeå University, Umeå, Sweden.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700021989991']
501,33591621,Liraglutide hospital discharge trial: A randomized controlled trial comparing the safety and efficacy of liraglutide versus insulin glargine for the management of patients with type 2 diabetes after hospital discharge.,"AIM


To compare a glucagon-like peptide-1 receptor agonist with basal insulin at hospital discharge in patients with uncontrolled type 2 diabetes in a randomized clinical trial.
METHODS


A total of 273 patients with glycated haemoglobin (HbA1c) 7%-10% (53-86 mol/mol) were randomized to liraglutide (n = 136) or insulin glargine (n = 137) at hospital discharge. The primary endpoint was difference in HbA1c at 12 and 26 weeks. Secondary endpoints included hypoglycaemia, changes in body weight, and achievement of HbA1c <7% (53 mmol/mol) without hypoglycaemia or weight gain.
RESULTS


The between-group difference in HbA1c at 12 weeks and 26 weeks was -0.28% (95% CI -0.64, 0.09), and at 26 weeks it was -0.55%, (95% CI -1.01, -0.09) in favour of liraglutide. Liraglutide treatment resulted in a lower frequency of hypoglycaemia <3.9 mmol/L (13% vs 23%; P = 0.04), but there was no difference in the rate of clinically significant hypoglycaemia <3.0 mmol/L. Compared to insulin glargine, liraglutide treatment was associated with greater weight loss at 26 weeks (-4.7 ± 7.7 kg vs -0.6 ± 11.5 kg; P < 0.001), and the proportion of patients with HbA1c <7% (53 mmol/mol) without hypoglycaemia was 48% versus 33% (P = 0.05) at 12 weeks and 45% versus 33% (P = 0.14) at 26 weeks in liraglutide versus insulin glargine. The proportion of patients with HbA1c <7% (53 mmol/mol) without hypoglycaemia and no weight gain was higher with liraglutide at 12 (41% vs 24%, P = 0.005) and 26 weeks (39% vs 22%; P = 0.014). The incidence of gastrointestinal adverse events was higher with liraglutide than with insulin glargine (P < 0.001).
CONCLUSION


Compared to insulin glargine, treatment with liraglutide at hospital discharge resulted in better glycaemic control and greater weight loss, but increased gastrointestinal adverse events.",2021,"The incidence of gastrointestinal adverse events was higher with liraglutide than with glargine (p < 0.001).
","['273 patients with HbA1c 7-10', 'Patients with Type 2 Diabetes After Hospital Discharge', 'patients with uncontrolled type 2 diabetes']","['glargine', 'liraglutide', 'liraglutide vs glargine insulin', 'glargine, liraglutide', 'Liraglutide', 'Liraglutide versus Glargine Insulin', 'GLP-1 receptor analog with basal insulin', 'insulin glargine']","['hypoglycaemia and no weight gain', 'weight loss', 'hypoglycaemia, changes in body weight, and achievement of HbA1c <7% without hypoglycaemia or weight gain', 'incidence of gastrointestinal adverse events', 'gastrointestinal adverse events', 'rate of clinically significant hypoglycaemia', 'frequency of hypoglycaemia', 'hypoglycaemia', 'glycaemic control and greater weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",273.0,0.179486,"The incidence of gastrointestinal adverse events was higher with liraglutide than with glargine (p < 0.001).
","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Urrutia', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Karla W Z', 'Initials': 'KWZ', 'LastName': 'Coronado', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Albury', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Mireya C', 'Initials': 'MC', 'LastName': 'Perez-Guzman', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Rodolfo J', 'Initials': 'RJ', 'LastName': 'Galindo', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Chaudhuri', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Iacobellis', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Palacios', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Javier M', 'Initials': 'JM', 'LastName': 'Farias', 'Affiliation': 'Division of Endocrinology Sanatorio Guemes, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gomez', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Anzola', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Migdal', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Deartment of Biostatistics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14347']
502,33589705,Associations of early pregnancy BMI with adverse pregnancy outcomes and infant neurocognitive development.,"The prevalence of overweight and obesity amongst reproductive women has been increasing worldwide. Our aim was to compare pregnancy outcomes and infant neurocognitive development by different BMI classifications and investigate whether early pregnancy BMI was associated with risks of adverse outcomes in a Southwest Chinese population. We analysed data from 1273 women enrolled in the Complex Lipids in Mothers and Babies (CLIMB) randomized controlled trial in Chongqing, China. Maternal BMI was classified as underweight, normal weight and overweight/obese according to the Chinese, WHO Asian, and WHO European standards. For the adverse pregnancy outcomes, after adjustment for potential confounders, an underweight BMI was associated with increased risk of small for gestational age (SGA) babies, and an overweight/obese BMI was associated with increased risk of maternal gestational diabetes mellitus (GDM), caesarean section (C-section), macrosomia and large for gestational age (LGA) babies. For infant neurocognitive development, 1017 mothers and their children participated; no significant differences were seen in the Mental Development Index (MDI) or the Psychomotor Development Index (PDI) between the three BMI groups. Our findings demonstrate that abnormal early pregnancy BMI were associated with increased risks of adverse pregnancy outcomes in Chinese women, while early pregnancy BMI had no significant influence on the infant neurocognitive development at 12 months of age.",2021,"For infant neurocognitive development, 1017 mothers and their children participated; no significant differences were seen in the Mental Development Index (MDI) or the Psychomotor Development Index (PDI) between the three BMI groups.","['1273 women enrolled in the Complex Lipids in Mothers and Babies (CLIMB) randomized controlled trial in Chongqing, China', 'a Southwest Chinese population', 'Chinese women']",[],"['infant neurocognitive development', 'Maternal BMI', 'risks of adverse pregnancy outcomes', 'risk of small for gestational age (SGA) babies', 'risk of maternal gestational diabetes mellitus (GDM), caesarean section (C-section), macrosomia and large for gestational age (LGA) babies', 'Mental Development Index (MDI) or the Psychomotor Development Index (PDI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392358', 'cui_str': 'Psychomotor development'}]",1273.0,0.0379047,"For infant neurocognitive development, 1017 mothers and their children participated; no significant differences were seen in the Mental Development Index (MDI) or the Psychomotor Development Index (PDI) between the three BMI groups.","[{'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Chen', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Institute of Life Sciences, Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Yin-Yin', 'Initials': 'YY', 'LastName': 'Xia', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Chongqing, 400016, China. 100118@cqmu.edu.cn.'}, {'ForeName': 'Ting-Li', 'Initials': 'TL', 'LastName': 'Han', 'Affiliation': 'Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Xu-Yang', 'Initials': 'XY', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'He', 'Affiliation': 'Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Institute of Life Sciences, Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'Institute of Life Sciences, Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Hong-Bo', 'Initials': 'HB', 'LastName': 'Qi', 'Affiliation': 'Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Benjamin B', 'Initials': 'BB', 'LastName': 'Albert', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Colombo', 'Affiliation': 'Department of Psychology and Schiefelbusch Institute for Life Span Studies, University of Kansas, Lawrence, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Baker', 'Affiliation': 'College of Life Sciences, University of Leicester, Leicester, UK.'}]",Scientific reports,['10.1038/s41598-021-83430-7']
503,33590342,Recreational beach tennis reduces 24-h blood pressure in adults with hypertension: a randomized crossover trial.,"PURPOSE


To evaluate the effect of a beach tennis session on 24-h ambulatory blood pressure in adults with hypertension.
METHODS


In this randomized crossover trial, 24 participants (12 men and 12 women) randomly performed two experimental sessions: a beach tennis session and a non-exercise control session. The beach tennis session started with a standardized 5-min warm-up consisting of basic techniques, followed by three 12-min beach tennis matches with 2-min intervals between them. Heart rate was continuously recorded and rating of perceived exertion was assessed in the middle and at the end of each set during the beach tennis session. Enjoyment was also assessed after the beach tennis session. The control session was performed in seated rest. Both experimental sessions lasted 45 min. Ambulatory blood pressure was measured continuously for 24 h after sessions.
RESULTS


Systolic blood pressure (24-h: 6 mmHg, P = 0.008; daytime: 6 mmHg, P = 0.031; nighttime: 6 mmHg, P = 0.042) and diastolic blood pressure (24-h: 3 mmHg, P = 0.021; daytime: 3 mmHg, P = 0.036; nighttime: 4 mmHg, P = 0.076) decreased after beach tennis when compared with control. The participants presented a reserve heart rate of 59-68%, and a rating of perceived exertion score of 3.4-4.7 using Borg's CR10 Scale. The enjoyment scores after beach tennis session were higher than 90%.
CONCLUSION


A single session of recreational beach tennis reduces 24-h ambulatory blood pressure in adults with hypertension. Additionally, the participants can achieve a high physiological stress but perceive less effort during the practice.
TRIAL REGISTRATION


Date: April 10, 2019; identifier number NCT03909308 (Clinicaltrials.gov).",2021,A single session of recreational beach tennis reduces 24-h ambulatory blood pressure in adults with hypertension.,"['adults with hypertension', '24 participants (12 men and 12 women']","['Recreational beach tennis', 'beach tennis session', 'beach tennis session and a non-exercise control session', 'recreational beach tennis']","['diastolic blood pressure (24-h', '24-h blood pressure', 'daytime', 'Ambulatory blood pressure', 'Systolic blood pressure (24-h', 'enjoyment scores', '24-h ambulatory blood pressure', 'reserve heart rate', 'Heart rate', 'Enjoyment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0331781', 'cui_str': 'Beach'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",24.0,0.0343098,A single session of recreational beach tennis reduces 24-h ambulatory blood pressure in adults with hypertension.,"[{'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Carpes', 'Affiliation': 'Graduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Jacobsen', 'Affiliation': 'Sports and Exercise Training Study Group, Hospital de Clínicas de Porto Alegre, Rua Ramiro Barcelos 2350, Porto Alegre, RS, 90035-903, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Domingues', 'Affiliation': 'Graduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Nathalia', 'Initials': 'N', 'LastName': 'Jung', 'Affiliation': 'Sports and Exercise Training Study Group, Hospital de Clínicas de Porto Alegre, Rua Ramiro Barcelos 2350, Porto Alegre, RS, 90035-903, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ferrari', 'Affiliation': 'Graduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. rod.ferrari84@gmail.com.'}]",European journal of applied physiology,['10.1007/s00421-021-04617-4']
504,33580663,"Negative Attitudes, Self-efficacy, and Relapse Management Mediate Long-Term Adherence to Exercise in Patients With Heart Failure.","BACKGROUND


Exercise is safe and provides considerable benefits for patients with heart failure (HF) including improved function, quality of life, and symptoms. However, patients with HF have difficulty initiating and adhering to an exercise regimen. To improve adherence, our team developed Heart Failure Exercise and Resistance Training (HEART) Camp, a multicomponent, theory-driven intervention that was efficacious in a randomized controlled trial of long-term adherence to exercise in patients with HF. Identifying active components of efficacious interventions is a priority.
PURPOSE


The purpose of this study is to use mediation analysis to determine which interventional components accounted for long-term adherence to exercise in patients with HF.
METHODS


This study included 204 patients with HF enrolled in a randomized controlled trial. Instruments measuring interventional components were completed at baseline, 6, 12, and 18 months. Hierarchical linear models generated slope estimates to be used as predictors in logistic regression models. Significant variables were tested for indirect effects using path analyses with 1,000 bootstrapped estimates.
RESULTS


Significant mediation effects were observed for the interventional components of negative attitudes (β NA = 0.368, s.e. = 0.062, p < .001), self-efficacy (β SE = 0.190, s.e. = 0.047, p < .001), and relapse management (β RM = 0.243, s.e. = 0.076, p = .001).
CONCLUSIONS


These findings highlight improving attitudes, self-efficacy, and managing relapse as key interventional components to improve long-term adherence to exercise in patients with HF. Future interventions targeting adherence to exercise in patients with HF and other chronic illnesses should consider the incorporation of these active components.",2021,"(HEART) Camp, a multicomponent, theory-driven intervention that was efficacious in a randomized controlled trial of long-term adherence to exercise in patients with HF.","['204 patients with HF enrolled in a randomized controlled trial', 'patients with HF and other chronic illnesses', 'Patients With Heart Failure', 'patients with HF', 'patients with heart failure (HF']",['Heart Failure Exercise and Resistance Training'],"['interventional components of negative attitudes', 'self-efficacy', 'relapse management', 'Negative Attitudes, Self-efficacy, and Relapse Management Mediate Long-Term Adherence to Exercise']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1262620', 'cui_str': 'Negative attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",204.0,0.0330396,"(HEART) Camp, a multicomponent, theory-driven intervention that was efficacious in a randomized controlled trial of long-term adherence to exercise in patients with HF.","[{'ForeName': 'Windy W', 'Initials': 'WW', 'LastName': 'Alonso', 'Affiliation': 'University of Nebraska Medical Center, College of Nursing, Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kupzyk', 'Affiliation': 'University of Nebraska Medical Center, College of Nursing, Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Norman', 'Affiliation': 'University of Nebraska Medical Center, College of Allied Health, Omaha, NE.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Bills', 'Affiliation': 'University of Nebraska Medical Center, College of Allied Health, Omaha, NE.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Bosak', 'Affiliation': 'University of Kansas Medical Center, School of Nursing, Kansas City, KS.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Dunn', 'Affiliation': 'Department of Biobehavioral Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Pallav', 'Initials': 'P', 'LastName': 'Deka', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI.'}, {'ForeName': 'Bunny', 'Initials': 'B', 'LastName': 'Pozehl', 'Affiliation': 'University of Nebraska Medical Center, College of Nursing, Nebraska Medical Center, Omaha, NE.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab002']
505,33580651,The Impact of a Randomized Controlled Trial of a Lifestyle Intervention on Sleep Among Latina Postpartum Women.,"BACKGROUND


Poor sleep is associated with adverse outcomes among postpartum women. Exercise may improve sleep, but this has not been well examined in the postpartum period.
PURPOSE


To examine the impact of a culturally modified, individually tailored lifestyle intervention on sleep outcomes among postpartum Latina women.
METHODS


Estudio PARTO was a randomized controlled trial aimed at reducing Type 2 diabetes among Latina women with abnormal glucose tolerance in pregnancy. Participants were randomized to a lifestyle (i.e., diet and exercise; n = 70) or a health and wellness control intervention (n = 78) in late pregnancy (baseline). The Pittsburgh Sleep Quality Index (PSQI) was used to measure sleep quality (PSQI score), onset latency (minutes per night), duration (hours per night), efficiency (percentage of the time in bed asleep), and daytime dysfunction at baseline, 6 weeks, 6 months, and 12 months postpartum.
RESULTS


Mean PSQI score (6.56 ± 3.87), sleep duration (6.84 ± 1.75 hr/night), and sleep efficiency (79.70% ± 18.10%) did not differ between the arms at baseline. Mixed-effects models indicated a greater decrease of 1.29 in PSQI score (i.e., improved sleep quality) in the lifestyle versus health and wellness arm (95% confidence interval [CI] = -2.50 to -0.08, p = .04) over follow-up. There was the suggestion of a smaller decrease in sleep duration (mean = 0.48 hr/night, 95% CI = -0.10 to 1.06, p = .10) in the lifestyle versus health and wellness arm. There were no statistically significant differences in other sleep outcomes between arms.
CONCLUSIONS


Findings suggest that lifestyle interventions improve sleep quality but not sleep duration, sleep onset latency, sleep efficiency, or daytime dysfunction in postpartum Latina women and, therefore, may hold promise for improving subsequent mental and physical health in this population.
CLINICAL TRIALS REGISTRATION


NCT01679210.",2021,"hr/night, 95% CI = -0.10 to 1.06, p = .10) in the lifestyle versus health and wellness arm.","['Latina women with abnormal glucose tolerance in pregnancy', 'postpartum Latina women', 'Latina Postpartum Women', 'postpartum women']","['lifestyle interventions', 'health and wellness control intervention', 'culturally modified, individually tailored lifestyle intervention', 'Lifestyle Intervention']","['Pittsburgh Sleep Quality Index (PSQI', 'sleep duration', 'PSQI score', 'sleep quality', 'sleep duration, sleep onset latency, sleep efficiency, or daytime dysfunction', 'sleep outcomes', 'sleep efficiency', 'Mean PSQI score', 'sleep quality (PSQI score), onset latency (minutes per night), duration (hours per night), efficiency (percentage of the time in bed asleep), and daytime dysfunction']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0342307', 'cui_str': 'Impaired glucose tolerance in pregnancy'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}]",,0.110675,"hr/night, 95% CI = -0.10 to 1.06, p = .10) in the lifestyle versus health and wellness arm.","[{'ForeName': 'Marquis', 'Initials': 'M', 'LastName': 'Hawkins', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Pekow', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Milagros C', 'Initials': 'MC', 'LastName': 'Rosal', 'Affiliation': 'Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Tucker', 'Affiliation': 'Department of Biomedical and Nutritional Sciences, University of Massachusetts Lowell, Lowell, MA, USA.'}, {'ForeName': 'Rebecca M C', 'Initials': 'RMC', 'LastName': 'Spencer', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chasan-Taber', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Massachusetts, Amherst, MA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa118']
506,33582295,Harnessing mobile technology to reduce mental health disorders in college populations: A randomized controlled trial study protocol.,"About a third of college students struggle with anxiety, depression, or an eating disorder, and only 20-40% of college students with mental disorders receive treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for a new approach to detect mental health problems and engage college students in services. We have developed a transdiagnostic, low-cost mobile mental health targeted prevention and intervention platform that uses population-level screening to engage college students in tailored services that address common mental health problems. We will test the impact of this mobile mental health platform for service delivery in a large-scale trial across 20+ colleges. Students who screen positive or at high-risk for clinical anxiety, depression, or an eating disorder and who are not currently engaged in mental health services (N = 7884) will be randomly assigned to: 1) intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center). We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases, disorder-specific symptoms, and improved quality of life and functioning. We will also test mediators, predictors, and moderators of improved mental health outcomes, as well as stakeholder-relevant outcomes, including cost-effectiveness and academic performance. This population-level approach to service engagement has the potential to improve mental health outcomes for the millions of students enrolled in U.S. colleges and universities.",2021,"We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases and disorder-specific symptoms, and improved quality of life and functioning.","['college students struggle with anxiety, depression, or an eating disorder, and only 20-40% of college students with mental disorders receive treatment', 'students enrolled in U.S. colleges and universities', 'Students who screen positive or at high-risk for clinical anxiety, depression, or an eating disorder and who are not currently engaged in mental health services (N\u202f=\u202f7884', 'college populations']","['Harnessing mobile technology', 'intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center']","['cost-effectiveness and academic performance', 'mental health disorders']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",7884.0,0.257177,"We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases and disorder-specific symptoms, and improved quality of life and functioning.","[{'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Fitzsimmons-Craft', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: fitzsimmonse@wustl.edu.'}, {'ForeName': 'C Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA. Electronic address: btaylor@stanford.edu.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, Penn State University, University Park, PA, USA. Electronic address: mgn1@psu.edu.'}, {'ForeName': 'Nur Hani', 'Initials': 'NH', 'LastName': 'Zainal', 'Affiliation': 'Department of Psychology, Penn State University, University Park, PA, USA. Electronic address: nvz5057@psu.edu.'}, {'ForeName': 'Elsa E', 'Initials': 'EE', 'LastName': 'Rojas-Ashe', 'Affiliation': 'Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA. Electronic address: erojas@paloaltou.edu.'}, {'ForeName': 'Sarah Ketchen', 'Initials': 'SK', 'LastName': 'Lipson', 'Affiliation': 'Department of Health Law Policy and Management, Boston University School of Public Health, Boston, MA, USA. Electronic address: sklipson@bu.edu.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Firebaugh', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: mcallewaert@wustl.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ceglarek', 'Affiliation': 'Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, USA. Electronic address: peterceg@umich.edu.'}, {'ForeName': 'Naira', 'Initials': 'N', 'LastName': 'Topooco', 'Affiliation': 'Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA; Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden. Electronic address: naira.topooco@liu.se.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Jacobson', 'Affiliation': 'Departments of Biomedical Data Science and Psychiatry, Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Hanover, NH, USA. Electronic address: Nicholas.C.Jacobson@dartmouth.edu.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA. Electronic address: andrea.graham@northwestern.edu.'}, {'ForeName': 'Hyungjin Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA. Electronic address: myrakim@umich.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eisenberg', 'Affiliation': 'Department of Health Policy and Management, Fielding School of Public Health, University of California at Los Angeles, Los Angeles, CA, USA. Electronic address: daniel.eisenberg@ucla.edu.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: wilfleyd@wustl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106320']
507,33589674,Insights into the role of diet and dietary flavanols in cognitive aging: results of a randomized controlled trial.,"With the world's population aging, age-related memory decline is an impending cognitive epidemic. Assessing the impact of diet on cognitive aging, we conducted a controlled, randomized, parallel-arm dietary intervention with 211 healthy adults (50-75 years) investigating effects of either a placebo or 260, 510 and 770 mg/day of cocoa flavanols for 12-weeks followed by 8-weeks washout. The primary outcome was a newly-developed object-recognition task localized to the hippocampus' dentate gyrus. Secondary outcomes included a hippocampal-dependent list-learning task and a prefrontal cortex-dependent list-sorting task. The alternative Healthy Eating Index and a biomarker of flavanol intake (gVLM) were measured. In an MRI substudy, hippocampal cerebral blood volume was mapped. Object-recognition and list-sorting performance did not correlate with baseline diet quality and did not improve after flavanol intake. However, the hippocampal-dependent list-learning performance was directly associated with baseline diet quality and improved after flavanol intake, particularly in participants in the bottom tertile of baseline diet quality. In the imaging substudy, a region-of-interest analysis was negative but a voxel-based-analysis suggested that dietary flavanols target the dentate gyrus. While replication is needed, these findings suggest that diet in general, and dietary flavanols in particular, may be associated with memory function of the aging hippocampus and normal cognitive decline.",2021,Object-recognition and list-sorting performance did not correlate with baseline diet quality and did not improve after flavanol intake.,"['211 healthy adults (50-75\xa0years', 'cognitive aging']","['diet and dietary flavanols', 'placebo', 'cocoa flavanols']","['hippocampal-dependent list-learning task and a prefrontal cortex-dependent list-sorting task', 'Object-recognition and list-sorting performance', 'alternative Healthy Eating Index and a biomarker of flavanol intake (gVLM', 'hippocampal cerebral blood volume', ""newly-developed object-recognition task localized to the hippocampus' dentate gyrus""]","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4042952', 'cui_str': 'Cognitive Aging'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4277714', 'cui_str': 'Cerebral Blood Volume'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0152314', 'cui_str': 'Structure of dentate gyrus'}]",211.0,0.12004,Object-recognition and list-sorting performance did not correlate with baseline diet quality and did not improve after flavanol intake.,"[{'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Sloan', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry, Columbia University Irving Medical Center, 622 West 168th St., New York, NY, 10032, USA. rps7@cumc.columbia.edu.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wall', 'Affiliation': 'New York State Psychiatric Institute, 1050 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Lok-Kin', 'Initials': 'LK', 'LastName': 'Yeung', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, 622 West 168th St., New York, NY, 10032, USA.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'New York State Psychiatric Institute, 1050 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Xinyang', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, 622 West 168th St., New York, NY, 10032, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Provenzano', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, 622 West 168th St., New York, NY, 10032, USA.'}, {'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Schroeter', 'Affiliation': 'Mars Inc., 6885 Elm St, McLean, VA, 22101, USA.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Lauriola', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry, Columbia University Irving Medical Center, 622 West 168th St., New York, NY, 10032, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Brickman', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, 622 West 168th St., New York, NY, 10032, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Small', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, 622 West 168th St., New York, NY, 10032, USA. sas68@cumc.columbia.edu.'}]",Scientific reports,['10.1038/s41598-021-83370-2']
508,33589667,Effects of exercise on cervical muscle strength and cross-sectional area in patients with thoracic hyperkyphosis and chronic cervical pain.,"There is a lack of studies comparing the effects of different exercise types in patients with thoracic hyperkyphosis. Twenty-four subjects were divided into three groups: corrective exercise, resistance exercise, and physical therapy. The groups performed their respective interventions, two times per week for three months. Clinical outcomes, including the value of Cobb's angle, cervical muscle strength and endurance, and the cross-sectional area of the cervical deep muscles were measured pre- and post-intervention. There was a significant difference in the changes in the thoracic Cobb's angle between the groups (P < 0.001). The corrective exercise group revealed a significantly superior increase in muscle strength and endurance between pre- and post-intervention (P < 0.012). There was a significant difference in the cross-sectional area of the cervical deep muscles included longus capitis and multifidus between the groups (P < 0.036 and 0.007, respectively). The corrective exercise group showed the most significant increase in cross-sectional area between pre- and post-intervention (P < 0.012). A corrective exercise program is a more effective intervention than traditional resistance exercise and physical therapy for improving the thoracic Cobb's angle, cervical muscle strength and endurance, and the cross-sectional area of the deep muscles in patients with thoracic hyperkyphosis.Trial registration: KCT0005292.",2021,The corrective exercise group revealed a significantly superior increase in muscle strength and endurance between pre- and post-intervention (P < 0.012).,"['patients with thoracic hyperkyphosis and chronic cervical pain', 'patients with thoracic hyperkyphosis', 'Twenty-four subjects']","['corrective exercise, resistance exercise, and physical therapy', 'corrective exercise program', 'traditional resistance exercise and physical therapy', 'exercise']","['muscle strength and endurance', 'cross-sectional area of the cervical deep muscles included longus capitis and multifidus', 'cervical muscle strength', 'cross-sectional area', ""thoracic Cobb's angle"", ""value of Cobb's angle, cervical muscle strength and endurance, and the cross-sectional area of the cervical deep muscles""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0224107', 'cui_str': 'Structure of longus capitis muscle'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",24.0,0.022271,The corrective exercise group revealed a significantly superior increase in muscle strength and endurance between pre- and post-intervention (P < 0.012).,"[{'ForeName': 'Hyunghun', 'Initials': 'H', 'LastName': 'Moon', 'Affiliation': 'Department of Sports Medicine, Cha University, 120, Haeryong-ro, Pocheon-si, Gyeonggi-do, 11160, Republic of Korea.'}, {'ForeName': 'Sung-Ki', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Sports Medicine, Cha University, 120, Haeryong-ro, Pocheon-si, Gyeonggi-do, 11160, Republic of Korea. sklee@cha.ac.kr.'}, {'ForeName': 'Won-Moon', 'Initials': 'WM', 'LastName': 'Kim', 'Affiliation': 'Department of Sports Science, Dongguk University, 123, Dongdae-ro, Gyeongju-si, Gyeongsangbuk-do, Republic of Korea.'}, {'ForeName': 'Yong-Gon', 'Initials': 'YG', 'LastName': 'Seo', 'Affiliation': 'Division of Sports Medicine, Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 135-710, Republic of Korea. yongon79@naver.com.'}]",Scientific reports,['10.1038/s41598-021-83344-4']
509,33597580,"Caffeine may disrupt the impact of real-time drowsiness on cognitive performance: a double-blind, placebo-controlled small-sample study.","Caffeine is widely used to promote alertness and cognitive performance under challenging conditions, such as sleep loss. Non-digestive modes of delivery typically reduce variability of its effect. In a placebo-controlled, 50-h total sleep deprivation (TSD) protocol we administered four 200 mg doses of caffeine-infused chewing-gum during night-time circadian trough and monitored participants' drowsiness during task performance with infra-red oculography. In addition to the expected reduction of sleepiness, caffeine was found to disrupt its degrading impact on performance errors in tasks ranging from standard cognitive tests to simulated driving. Real-time drowsiness data showed that caffeine produced only a modest reduction in sleepiness (compared to our placebo group) but substantial performance gains in vigilance and procedural decisions, that were largely independent of the actual alertness dynamics achieved. The magnitude of this disrupting effect was greater for more complex cognitive tasks.",2021,"In addition to the expected reduction of sleepiness, caffeine was found to disrupt its degrading impact on performance errors in tasks ranging from standard cognitive tests to simulated driving.",[],"['caffeine', ""caffeine-infused chewing-gum during night-time circadian trough and monitored participants' drowsiness during task performance with infra-red oculography"", 'Caffeine', 'placebo']","['complex cognitive tasks', 'sleepiness']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",,0.0719103,"In addition to the expected reduction of sleepiness, caffeine was found to disrupt its degrading impact on performance errors in tasks ranging from standard cognitive tests to simulated driving.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Aidman', 'Affiliation': 'Defence Science and Technology Group, Edinburgh, 5111, Australia. eugene.aidman@dst.defence.gov.au.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balin', 'Affiliation': 'Defence Science and Technology Group, Edinburgh, 5111, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'Defence Science and Technology Group, Edinburgh, 5111, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jackson', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, Australia.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Paech', 'Affiliation': 'Behaviour-Brain-Body Research Group, Justice and Society, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pajcin', 'Affiliation': 'Clinical and Health Sciences, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Yates', 'Affiliation': 'Behaviour-Brain-Body Research Group, Justice and Society, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mitchelson', 'Affiliation': 'Defence Science and Technology Group, Edinburgh, 5111, Australia.'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Kamimori', 'Affiliation': 'Behavioral Biology Branch, Center for Military Psychiatry and Neuroscience Research, Walter Reed Army Institute of Research, Silver Spring, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fidock', 'Affiliation': 'Defence Science and Technology Group, Edinburgh, 5111, Australia.'}, {'ForeName': 'C Della', 'Initials': 'CD', 'LastName': 'Vedova', 'Affiliation': 'Clinical and Health Sciences, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Banks', 'Affiliation': 'Behaviour-Brain-Body Research Group, Justice and Society, University of South Australia, Adelaide, Australia.'}]",Scientific reports,['10.1038/s41598-021-83504-6']
510,33597586,Platelet-rich plasma (PRP) in osteoarthritis (OA) knee: Correct dose critical for long term clinical efficacy.,"Despite encouraging results reported with regards to Platelet-rich plasma (PRP) application in osteoarthritis (OA) knee, still critical issues like conclusive structural evidence of its efficacy, standard dose and good manual method of preparation to obtain high yield remains unanswered. Present study is an attempt to optimise the dose and concentration of therapeutic PRP and its correlation with structural, physiologic efficacy with a new manual method of PRP preparation. A total of one hundred and fifty patients were randomized to receive either PRP (10 billion platelets) or hyaluronic acid (HA; 4 ml; 75 patients in each group) and followed up till 1 year. An addition of filtration step with 1 µm filter in manual PRP processing improved platelet recovery upto 90%. Significant improvements in WOMAC (51.94 ± 7.35 vs. 57.33 ± 8.92; P < 0.001), IKDC scores (62.8 ± 6.24 vs 52.7 ± 6.39; P < 0.001), 6-min pain free walking distance (+ 120 vs. + 4; P < 0.001) persisted in PRP compared to HA group at 1 year. Significant decline IL-6 and TNF-α levels observed in PRP group (P < 0.05) compared to HA at 1 month. Study demonstrated that an absolute count of 10 billion platelets is crucial in a PRP formulation to have long sustained chondroprotective effect upto one year in moderate knee OA.",2021,Significant decline IL-6 and TNF-α levels observed in PRP group (P < 0.05) compared to HA at 1 month.,"['osteoarthritis (OA) knee', 'A total of one hundred and fifty patients']",['PRP (10 billion platelets) or hyaluronic acid (HA'],"['Platelet-rich plasma (PRP', 'PRP', '6-min pain free walking distance', 'Significant decline IL-6 and TNF-α levels', 'WOMAC', 'IKDC scores']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",150.0,0.0196164,Significant decline IL-6 and TNF-α levels observed in PRP group (P < 0.05) compared to HA at 1 month.,"[{'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Bansal', 'Affiliation': 'Mother Cell Spinal Injury and Stem Cell Research, Anupam Hospital, Rudrapur, Uttarakhand, India. hbansal@drhbf.org.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Leon', 'Affiliation': 'PMR Advance Health Institute Mayaguez, Puerto Rico, USA.'}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Pont', 'Affiliation': 'Pheonix Helse, Lillesand, Norway.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wilson', 'Affiliation': 'Pheonix Helse, Lillesand, Norway.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Mother Cell Spinal Injury and Stem Cell Research, Anupam Hospital, Rudrapur, Uttarakhand, India.'}, {'ForeName': 'Diwaker', 'Initials': 'D', 'LastName': 'Agarwal', 'Affiliation': 'Mercy Medical Centre, Roseburg, OR, USA.'}, {'ForeName': 'Iustin', 'Initials': 'I', 'LastName': 'Preoteasa', 'Affiliation': 'Alpha Medica Stem Clinic, Voineşti, Romania.'}]",Scientific reports,['10.1038/s41598-021-83025-2']
511,33603000,Plasma lipocalin-2/NGAL is stable over 12 weeks and is not modulated by exercise or dieting.,"Amongst other immune cells, neutrophils play a key role in systemic inflammation leading to cardiovascular disease and can release inflammatory factors, including lipocalin-2 (LCN2). LCN2 drives cardiac hypertrophy and plays a role in maladaptive remodelling of the heart and has been associated with renal injury. While lifestyle factors such as diet and exercise are known to attenuate low-grade inflammation, their ability to modulate plasma LCN2 levels is unknown. Forty-eight endurance athletes and 52 controls (18-55 years) underwent measurement for various cardiovascular health indicators, along with plasma LCN2 concentration. No significant difference in LCN2 concentration was seen between the two groups. LCN2 was a very weak predictor or absent from models describing blood pressures or predicting athlete status. In another cohort, 57 non-diabetic overweight or obese men and post-menopausal women who fulfilled Adult Treatment Panel III metabolic syndrome criteria were randomly allocated into either a control, modified Dietary Approaches to Stop Hypertension (DASH) diet, or DASH and exercise group. Pre- and post-intervention demographic, cardiovascular health indicators, and plasma LCN2 expression were measured in each individual. While BMI fell in intervention groups, LCN2 levels remained unchanged within and between all groups, as illustrated by strong correlations between LCN2 concentrations pre- and 12 weeks post-intervention (r = 0.743, P < 0.0001). This suggests that circulating LCN2 expression are stable over a period of at least 12 weeks and is not modifiable by diet and exercise.",2021,No significant difference in LCN2 concentration was seen between the two groups.,"['57 non-diabetic overweight or obese men and post-menopausal women who fulfilled Adult Treatment Panel III metabolic syndrome criteria', 'Forty-eight endurance athletes and 52 controls (18-55\xa0years']","['control, modified Dietary Approaches to Stop Hypertension (DASH) diet, or DASH and exercise group', 'LCN2']","['LCN2 concentration', 'LCN2 levels', 'Pre- and post-intervention demographic, cardiovascular health indicators, and plasma LCN2 expression']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}]","[{'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",57.0,0.0179885,No significant difference in LCN2 concentration was seen between the two groups.,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Nakai', 'Affiliation': 'Hypertension Research Laboratory, School of Biological Sciences, Faculty of Science, Monash University, 25 Rainforest Walk, Melbourne, Clayton, VIC, 3800, Australia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Denham', 'Affiliation': 'Discipline of Exercise and Sports Science, School of Health and Biomedical Sciences, RMIT University, Melbourne, VIC, 3083, Australia.'}, {'ForeName': 'Priscilla R', 'Initials': 'PR', 'LastName': 'Prestes', 'Affiliation': 'Faculty of Science and Technology, Federation University Australia, Mount Helen, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Eikelis', 'Affiliation': 'Iverson Health Innovation Research Institute and Faculty of Health, Arts and Design, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Lambert', 'Affiliation': 'Iverson Health Innovation Research Institute and Faculty of Health, Arts and Design, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Nora E', 'Initials': 'NE', 'LastName': 'Straznicky', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Markus P', 'Initials': 'MP', 'LastName': 'Schlaich', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Murray D', 'Initials': 'MD', 'LastName': 'Esler', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Brendan J', 'Initials': 'BJ', 'LastName': ""O'Brien"", 'Affiliation': 'Faculty of Science and Technology, Federation University Australia, Mount Helen, Australia.'}, {'ForeName': 'Fadi J', 'Initials': 'FJ', 'LastName': 'Charchar', 'Affiliation': 'Faculty of Science and Technology, Federation University Australia, Mount Helen, Australia.'}, {'ForeName': 'Gavin W', 'Initials': 'GW', 'LastName': 'Lambert', 'Affiliation': 'Iverson Health Innovation Research Institute and Faculty of Health, Arts and Design, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Francine Z', 'Initials': 'FZ', 'LastName': 'Marques', 'Affiliation': 'Hypertension Research Laboratory, School of Biological Sciences, Faculty of Science, Monash University, 25 Rainforest Walk, Melbourne, Clayton, VIC, 3800, Australia. Francine.marques@monash.edu.'}]",Scientific reports,['10.1038/s41598-021-83472-x']
512,33602996,Composite cardiovascular risk and BMI affected comparative profiles of BIAsp 30 + metformin vs BIAsp 30 monotherapy: a MERIT post-hoc analysis.,"We assessed whether comparative efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) plus metformin versus BIAsp 30 monotherapy differed for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with oral antidiabetic drugs with different cardiovascular risk scores and different body mass indexes (BMI) by performing a post hoc analysis of the randomized controlled MERIT study. In the MERIT study, eligible patients were randomized 1:1 to receive BIAsp 30 plus metformin or BIAsp 30 for 16 weeks. Patients in the 2 treatment groups were classified into ""low"" and ""high"" risk subgroups based on their GloboRisk scores and into ""BMI ≤ 26 kg/m 2 ""and ""BMI > 26 kg/m 2 "" subgroups. Primary efficacy endpoint was between-treatments comparison of HbA1c changes from baseline for these 2 sets of subgroups. Between-treatments comparisons of secondary efficacy and safety endpoints were also performed. We found that BIAsp 30 plus metformin led to significantly higher percentage of high-risk patients achieving HbA1c target < 7% than BIAsp 30 monotherapy, with an overall comparable safety profile for high-risk patients. Meanwhile, for patients with BMI ≤ 26 kg/m 2 , compared with BIAsp 30 monotherapy, BIAsp 30 plus metformin led to significantly higher percentages of patients achieving HbA1c target (47.83% vs 28.17%, P = 0.0165) and composite target of HbA1c < 7% without hypoglycemia or weight gain (20.29% vs 6.85%, P = 0.0187) and have a slightly better safety profile. In conclusion, for T2DM patients at high CV risk or with BMI ≤ 26 kg/m 2 , BIAsp 30 plus metformin was preferable to BIAsp 30 monotherapy.",2021,"We found that BIAsp 30 plus metformin led to significantly higher percentage of high-risk patients achieving HbA1c target < 7% than BIAsp 30 monotherapy, with an overall comparable safety profile for high-risk patients.","['patients with type 2 diabetes mellitus (T2DM) inadequately controlled with oral antidiabetic drugs with different cardiovascular risk scores and different body mass indexes (BMI', 'Patients in the 2 treatment groups were classified into ""low"" and ""high"" risk subgroups based on their GloboRisk scores and into ""BMI\u2009≤\u200926\xa0kg/m 2 ""and ""BMI\u2009>\u200926\xa0kg/m 2 "" subgroups']","['BIAsp 30\u2009+\u2009metformin vs BIAsp', 'BIAsp 30 plus metformin', 'biphasic insulin aspart 30 (BIAsp 30) plus metformin', 'metformin']","['HbA1c changes', 'patients achieving HbA1c target', 'hypoglycemia or weight gain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C2003521', 'cui_str': 'insulin aspart, insulin aspart protamine drug combination 30:70'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1318607', 'cui_str': 'HBA1c target'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",,0.0492131,"We found that BIAsp 30 plus metformin led to significantly higher percentage of high-risk patients achieving HbA1c target < 7% than BIAsp 30 monotherapy, with an overall comparable safety profile for high-risk patients.","[{'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Endocrinology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1, Dahua Road, Dongcheng District, Beijing, 100730, China. glx1218@163.com.'}, {'ForeName': 'Baocheng', 'Initials': 'B', 'LastName': 'Chang', 'Affiliation': 'Tianjin Medical University Metabolic Diseases Hospital, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Liyong', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Sir Run Run Shaw Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Shanghai East Hospital Affiliated To Tongji University, Shanghai, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Department of Endocrinology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1, Dahua Road, Dongcheng District, Beijing, 100730, China.'}]",Scientific reports,['10.1038/s41598-021-83410-x']
513,33596659,[Impact on the risk of malnutrition and depression of a clinical trial with nutritional educational intervention in non-institutionalized elderly subjects receiving a telecare service in Terrassa (Spain)].,"Introduction


Introduction: the elderly are a growing and vulnerable population. Depression and malnutrition are frequent, and there seems to be associated. Objectives: to assess the impact of a nutritional educational intervention on the risk of malnutrition and depression in elderly subjects. Methods: Analytical, experimental, randomized longitudinal study in 38 autonomous, non-institutionalized elderly subjects. Nutritional and depression risk were measured using the Mini Nutritional Assessment (MNA) and the Yesavage Geriatric Depression Scale (GDS-SF), respectively. The impact of the intervention was measured with nutrition and food security questionnaires. Statistics were performed with Spearman's correlation coefficient, and comparisons between means with the Student's t-test. A p-value  0.05 was considered significant. Results: 63.2 % of the sample had a good nutritional status, 28,9 % were at risk of malnutrition, and 7.9 % had malnutrition. Of the total of participants, 28.9 % had depression. A statistically significant, moderate and negative linear relationship was found between depression and nutritional risk (rho = -0.489; p  0.01). The nutritional educational intervention produced a significant increase in knowledge of food security (2.95 ± 2.53 compared to 0.37 ± 1.46; p  0.0005). Conclusions: the risks of malnutrition and depression are significantly associated in older adults. Furthermore, the nutritional educational intervention improved knowledge of food safety, but did not improve nutritional status or in the degree of depression.",2021,"The nutritional educational intervention produced a significant increase in knowledge of food security (2.95 ± 2.53 compared to 0.37 ± 1.46; p  0.0005).
","['older adults', 'non-institutionalized elderly subjects receiving a telecare service in Terrassa (Spain', 'elderly subjects', '38 autonomous, non-institutionalized elderly subjects']",['nutritional educational intervention'],"['malnutrition', 'knowledge of food security', 'Nutritional and depression risk', 'Mini Nutritional Assessment (MNA) and the Yesavage Geriatric Depression Scale (GDS-SF', 'knowledge of food safety', 'depression and nutritional risk']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}]",38.0,0.0143792,"The nutritional educational intervention produced a significant increase in knowledge of food security (2.95 ± 2.53 compared to 0.37 ± 1.46; p  0.0005).
","[{'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Arauco Lozada', 'Affiliation': 'Departamento de Nutrición, Ciencias de los Alimentos y Gastronomía. XaRTA - INSA. Facultat de Farmàcia. Universitat de Barcelona.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Garrido Carrasco', 'Affiliation': 'Departamento de Nutrición, Ciencias de los Alimentos y Gastronomía. XaRTA - INSA. Facultat de Farmàcia. Universitat de Barcelona.'}, {'ForeName': 'Andreu', 'Initials': 'A', 'LastName': 'Farran Codina', 'Affiliation': 'Departamento de Nutrición, Ciencias de los Alimentos y Gastronomía. XaRTA - INSA. Facultat de Farmàcia. Universitat de Barcelona.'}]",Nutricion hospitalaria,['10.20960/nh.03269']
514,33595427,"Anorectal application of 5% lidocaine cream reduces pain prior to periprostatic nerve block during transrectal ultrasound guided prostate biopsy: Randomized, prospective controlled study.","OBJECTIVES


Trans rectal ultrasound guided prostate biopsy with periprostatic nerve block (PPNB) is performed following probe insertion and manipulation leaving these initial maneuvers uncovered in terms of pain control. We evaluated whether topical analgesia reduces pain during early stages of the procedure.
PATIENTS AND METHODS


Seven group prospective, randomized controlled study: groups 1-3: nerve block with 5 ml 1% lidocaine bilaterally plus perianal topical application of 10 ml 5% lidocaine cream. Groups 4-6 as in 1-3 plus digital application of 10 ml 5% lidocaine cream internally on rectal walls. For each approach exposure times were 5 (groups 1 and 4), 10 (groups 2 and 5) and 20 (groups 3 and 6) min, respectively. The control group (7) received PPNB only. Patients filled a 0-10 visual analogue scale (VAS) at five points: after probe insertion, during probe manipulation, following PPNB, after prostate biopsies and a global pain estimation.
RESULTS


Two hundred and fifty-two patients were enrolled. Significant differences in VAS between all study groups and controls were observed at the pre-biopsy stages of the procedure. In multivariate analysis adjusted for prostate specific antigen, diabetes mellitus status, spinal disease, abnormal digital rectal examination and non- benign prostate hyperplasia histology, significance remained for probe insertion and intra-rectal manipulation. For each exposure time no significant differences were observed between topical application and topical + intra-rectal application. After PPNB, differences between study and control groups disappeared.
CONCLUSION


Topical anesthesia significantly reduces pain during early stages of prostate biopsy. Perianal application sufficed whereas intra-rectal application of local anesthetics does not add to pain control. Perianal application for 10 min seems to be optimal.",2021,For each exposure time no significant differences were observed between topical application and topical + intra-rectal application.,"['Two hundred and fifty-two patients were enrolled', 'transrectal ultrasound guided prostate biopsy']","['topical analgesia', 'nerve block with 5\u2009ml 1% lidocaine bilaterally plus perianal topical application of 10\u2009ml 5% lidocaine cream', 'Topical anesthesia', 'lidocaine cream', 'Trans rectal ultrasound guided prostate biopsy with periprostatic nerve block (PPNB']","['VAS', 'prostate specific antigen, diabetes mellitus status, spinal disease, abnormal digital rectal examination and non- benign prostate hyperplasia histology', 'pain', 'pain prior to periprostatic nerve block']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C2744579', 'cui_str': 'ATP8A2 protein, human'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442158', 'cui_str': 'Perianal'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}, {'cui': 'C1112240', 'cui_str': 'Rectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037933', 'cui_str': 'Disorder of vertebral column'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0199900', 'cui_str': 'Rectal examination'}, {'cui': 'C1704272', 'cui_str': 'Benign prostatic hyperplasia'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]",252.0,0.0827613,For each exposure time no significant differences were observed between topical application and topical + intra-rectal application.,"[{'ForeName': 'Yishai H', 'Initials': 'YH', 'LastName': 'Rappaport', 'Affiliation': 'Department of Urology, Shamir Medical Center (Asaf HaRofe), Zerifin, Israel.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Kravchick', 'Affiliation': 'Department of Urology, Upstate Urology of UHS, Johnson City, NY, USA.'}, {'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Neheman', 'Affiliation': 'Department of Urology, Shamir Medical Center (Asaf HaRofe), Zerifin, Israel.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Beberashvili', 'Affiliation': 'Department of Nephrology, Shamir Medical Center, Zerifin, Israel, affiliated to the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Kobi', 'Initials': 'K', 'LastName': 'Stav', 'Affiliation': 'Department of Urology, Shamir Medical Center (Asaf HaRofe), Zerifin, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Roizman', 'Affiliation': 'Department of Urology, Shamir Medical Center (Asaf HaRofe), Zerifin, Israel.'}, {'ForeName': 'Amnon', 'Initials': 'A', 'LastName': 'Zisman', 'Affiliation': 'Department of Urology, Shamir Medical Center (Asaf HaRofe), Zerifin, Israel.'}]",Scandinavian journal of urology,['10.1080/21681805.2021.1885484']
515,33603039,Peripheral BDNF and psycho-behavioral aspects are positively modulated by high-intensity intermittent exercise and fitness in healthy women.,"Acute high-intensity intermittent exercise (HIIE) induces the myokine secretion associated with neurogenesis, as well brain-derived neurotrophic factor (BDNF); however, it remains unknown how the menstrual phase influences this secretion after an acute exercise session. The current study aimed to investigate the effects of HIIE performed in luteal and follicular menstrual phases on BDNF, cognitive function, mood, and exercise enjoyment. Fourteen healthy women completed four experimental sessions, randomly. One graded exercise test (GXT) and one HIIE session (10 × 1-min runs 90% peak GXT velocity [1-min recovery]) were performed for each menstrual phase. Blood samples were collected at rest and immediately after efforts, and the profile of mood states questionnaire (POMS) and Stroop-task test were applied. During the HIIE, subjective scales were applied (feeling, felt arousal, rate of perceived exertion, and physical activity enjoyment). The main results showed that the serum BDNF presented no difference between menstrual phases (p = 0.870); however, HIIE increased BDNF concentration in both menstrual phases (p = 0.030). In addition, the magnitude of circulating BDNF variation (Δ%BDNF) and [Formula: see text] demonstrated an inverse relationship in the follicular phase (r =  - 0.539, p = 0.046), whereas in the luteal phase, Δ%BDNF was negatively correlated with time test (r =  - 0.684, p = 0.007) and RPE (r =  - 0.726, p = 0.004) in GXT. No differences between menstrual phases were observed for POMS (p ≥ 0.05); however, HIIE attenuated tension (p < 0.01), depression (p < 0.01), and anger moods (p < 0.01), independently of menstrual phases. The subjective scales and Stroop-task test did not show differences. In conclusion, menstrual cycle phase does not affect serum BDNF levels, cognitive function, mood, and exercise enjoyment. Contrary, HIIE increases peripheral BDNF and attenuates tension, depression, and anger independently of menstrual phase. In addition, Δ%BDNF was correlated with physical fitness in the follicular phase, exhibiting higher changes in women with lower physical fitness status.",2021,"No differences between menstrual phases were observed for POMS (p ≥ 0.05); however, HIIE attenuated tension (p < 0.01), depression (p < 0.01), and anger moods (p < 0.01), independently of menstrual phases.","['Fourteen healthy women', 'healthy women']","['graded exercise test (GXT) and one HIIE session ', 'Acute high-intensity intermittent exercise (HIIE', 'Δ%BDNF']","['BDNF concentration', 'magnitude of circulating BDNF variation (Δ%BDNF', 'POMS', 'serum BDNF levels, cognitive function, mood, and exercise enjoyment', 'RPE', 'anger moods', 'profile of mood states questionnaire (POMS) and Stroop-task test', 'subjective scales and Stroop-task test', 'peripheral BDNF and attenuates tension, depression, and anger independently of menstrual phase', 'depression', 'BDNF, cognitive function, mood, and exercise enjoyment', 'HIIE, subjective scales were applied (feeling, felt arousal, rate of perceived exertion, and physical activity enjoyment', 'Blood samples']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",14.0,0.0197868,"No differences between menstrual phases were observed for POMS (p ≥ 0.05); however, HIIE attenuated tension (p < 0.01), depression (p < 0.01), and anger moods (p < 0.01), independently of menstrual phases.","[{'ForeName': 'Rodrigo Araujo Bonetti', 'Initials': 'RAB', 'LastName': 'de Poli', 'Affiliation': 'Laboratory of Physiology and Sport Performance (LAFIDE), Post-Graduate Program in Movement Sciences, Department of Physical Education, School of Sciences, São Paulo State University (UNESP), Av. Eng. Luiz Edmundo Carrijo Coube, 14-01, Vargem LimpaBauru, SP, CEP 17033-360, Brazil.'}, {'ForeName': 'Vithor Hugo Fialho', 'Initials': 'VHF', 'LastName': 'Lopes', 'Affiliation': 'Laboratory of Physiology and Sport Performance (LAFIDE), Post-Graduate Program in Movement Sciences, Department of Physical Education, School of Sciences, São Paulo State University (UNESP), Av. Eng. Luiz Edmundo Carrijo Coube, 14-01, Vargem LimpaBauru, SP, CEP 17033-360, Brazil.'}, {'ForeName': 'Fábio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Alessandro Moura', 'Initials': 'AM', 'LastName': 'Zagatto', 'Affiliation': 'Laboratory of Physiology and Sport Performance (LAFIDE), Post-Graduate Program in Movement Sciences, Department of Physical Education, School of Sciences, São Paulo State University (UNESP), Av. Eng. Luiz Edmundo Carrijo Coube, 14-01, Vargem LimpaBauru, SP, CEP 17033-360, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Jimenez-Maldonado', 'Affiliation': 'Facultad de Deportes Campus Ensenada, Universidad Autónoma de Baja California, Ensenada, Mexico.'}, {'ForeName': 'Barbara Moura', 'Initials': 'BM', 'LastName': 'Antunes', 'Affiliation': 'Laboratory of Physiology and Sport Performance (LAFIDE), Post-Graduate Program in Movement Sciences, Department of Physical Education, School of Sciences, São Paulo State University (UNESP), Av. Eng. Luiz Edmundo Carrijo Coube, 14-01, Vargem LimpaBauru, SP, CEP 17033-360, Brazil. ba.antunes2@gmail.com.'}]",Scientific reports,['10.1038/s41598-021-83072-9']
516,33594151,Apical debris extrusion during instrumentation of oval root canals in primary teeth using manual versus motorized files: an ex vivo study.,"This study aimed to assess the apical extrusion of debris during instrumentation of primary canines using three endodontic file types. Forty-five extracted primary canines were randomly assigned to three instrumentation groups (n = 15): Hand K-files; and the motorized Kedo-S files and XP-endo Shaper files. The apically extruded debris produced during the procedure was collected and dried in pre-weighed Eppendorf tubes, and the mass of debris was calculated. The time required for the endodontic procedure was also recorded. Analysis of variance (ANOVA) and Tukey's post hoc test were used with a significance level set at 5%. XP-endo Shaper and Kedo-S files extruded significantly less debris compared with hand K-files with means of 0.84 ± 0.31 and 1.20 ± 0.67 mg respectively, compared to 2.13 ± 0.31 mg (p < 0.0001). No significant difference was found between the two motorized files. Less time was required to complete the procedure with the XP-endo Shaper compared to the hand K-files (p < 0.0001) and Kedo-S files (p < 0.0001). Within the limitations of the present study, it may be concluded that motorized files extruded less debris and required less instrumentation time compared to traditional K-files, which could benefit paediatric patients with root canal treatment needs.",2021,"XP-endo Shaper and Kedo-S files extruded significantly less debris compared with hand K-files with means of 0.84 ± 0.31 and 1.20 ± 0.67 mg respectively, compared to 2.13 ± 0.31 mg (p < 0.0001).",['Forty-five extracted primary canines'],['motorized Kedo-S files and XP-endo Shaper files'],['time required for the endodontic procedure'],"[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}]","[{'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}]",45.0,0.0384097,"XP-endo Shaper and Kedo-S files extruded significantly less debris compared with hand K-files with means of 0.84 ± 0.31 and 1.20 ± 0.67 mg respectively, compared to 2.13 ± 0.31 mg (p < 0.0001).","[{'ForeName': 'Bhaggyashri A', 'Initials': 'BA', 'LastName': 'Pawar', 'Affiliation': 'Department of Oral Health and Advanced Dentistry, Sir H. N. Reliance Foundation Hospital and Research Centre, Mumbai, Maharashtra, India.'}, {'ForeName': 'Ajinkya M', 'Initials': 'AM', 'LastName': 'Pawar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Nair Hospital Dental College, Mumbai, Maharashtra, India.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Atram', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Nair Hospital Dental College, Mumbai, Maharashtra, India.'}, {'ForeName': 'Alexander Maniangat', 'Initials': 'AM', 'LastName': 'Luke', 'Affiliation': 'Department of Surgical Sciences, College of Dentistry, Ajman University, Ajman, UAE.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, College of Dental Sciences and Hospital, Rau, Indore, India.'}, {'ForeName': 'Anda', 'Initials': 'A', 'LastName': 'Kfir', 'Affiliation': 'Department of Endodontology, The Goldschleger School of Dental Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Zvi', 'Initials': 'Z', 'LastName': 'Metzger', 'Affiliation': 'Department of Endodontology, The Goldschleger School of Dental Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dian Agustin', 'Initials': 'DA', 'LastName': 'Wahjuningrum', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dental Medicine, Universitas Airlangga, Jl. Moestopo 47, Surabaya, Jawa Timur, Indonesia. dian-agustin-w@fkg.unair.ac.id.'}]",Scientific reports,['10.1038/s41598-021-83522-4']
517,33592176,"A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: a randomised, open-label, phase 2 trial.","BACKGROUND


MET (also known as hepatocyte growth factor receptor) signalling is a key driver of papillary renal cell carcinoma (PRCC). Given that no optimal therapy for metastatic PRCC exists, we aimed to compare an existing standard of care, sunitinib, with the MET kinase inhibitors cabozantinib, crizotinib, and savolitinib for treatment of patients with PRCC.
METHODS


We did a randomised, open-label, phase 2 trial done in 65 centres in the USA and Canada. Eligible patients were aged 18 years or older with metastatic PRCC who had received up to one previous therapy (excluding vascular endothelial growth factor-directed and MET-directed agents). Patients were randomly assigned to receive sunitinib, cabozantinib, crizotinib, or savolitinib, with stratification by receipt of previous therapy and PRCC subtype. All drug doses were administered orally: sunitinib 50 mg, 4 weeks on and 2 weeks off (dose reductions to 37·5 mg and 25 mg allowed); cabozantinib 60 mg daily (reductions to 40 mg and 20 mg allowed); crizotinib 250 mg twice daily (reductions to 200 mg twice daily and 250 mg once daily allowed); and savolitinib 600 mg daily (reductions to 400 mg and 200 mg allowed). Progression-free survival (PFS) was the primary endpoint. Analyses were done in an intention-to-treat population, with patients who did not receive protocol therapy excluded from safety analyses. This trial is registered with ClinicalTrials.gov, NCT02761057.
FINDINGS


Between April 5, 2016, and Dec 15, 2019, 152 patients were randomly assigned to one of four study groups. Five patients were identified as ineligible post-randomisation and were excluded from these analyses, resulting in 147 eligible patients. Assignment to the savolitinib (29 patients) and crizotinib (28 patients) groups was halted after a prespecified futility analysis; planned accrual was completed for both sunitinib (46 patients) and cabozantinib (44 patients) groups. PFS was longer in patients in the cabozantinib group (median 9·0 months, 95% CI 6-12) than in the sunitinib group (5·6 months, 3-7; hazard ratio for progression or death 0·60, 0·37-0·97, one-sided p=0·019). Response rate for cabozantinib was 23% versus 4% for sunitinib (two-sided p=0·010). Savolitinib and crizotinib did not improve PFS compared with sunitinib. Grade 3 or 4 adverse events occurred in 31 (69%) of 45 patients receiving sunitinib, 32 (74%) of 43 receiving cabozantinib, ten (37%) of 27 receiving crizotinib, and 11 (39%) of 28 receiving savolitinib; one grade 5 thromboembolic event was recorded in the cabozantinib group.
INTERPRETATION


Cabozantinib treatment resulted in significantly longer PFS compared with sunitinib in patients with metastatic PRCC.
FUNDING


National Institutes of Health and National Cancer Institute.",2021,"PFS was longer in patients in the cabozantinib group (median 9·0 months, 95% CI 6-12) than in the sunitinib group (5·6 months, 3-7; hazard ratio for progression or death 0·60","['Five patients were identified as ineligible post-randomisation and were excluded from these analyses, resulting in 147 eligible patients', 'advanced papillary renal cell carcinoma', 'papillary renal cell carcinoma (PRCC', 'Between April 5, 2016, and Dec 15, 2019, 152 patients', 'Eligible patients were aged 18 years or older with metastatic PRCC who had received up to one previous therapy (excluding vascular endothelial growth factor-directed and MET-directed agents', 'patients with metastatic PRCC', '65 centres in the USA and Canada', 'patients with PRCC', '29 patients) and crizotinib (28 patients) groups was halted after a prespecified futility analysis; planned accrual was completed for both sunitinib (46 patients) and cabozantinib (44 patients) groups']","['sunitinib, cabozantinib, crizotinib, or savolitinib, with stratification by receipt of previous therapy and PRCC subtype', 'sunitinib with cabozantinib, crizotinib, and savolitinib', 'cabozantinib 60 mg daily (reductions to 40 mg and 20 mg allowed); crizotinib 250 mg twice daily (reductions to 200 mg twice daily and 250 mg once daily allowed); and savolitinib', 'savolitinib']","['PFS', 'Progression-free survival (PFS', 'Response rate for cabozantinib', 'grade 5 thromboembolic event', 'Grade 3 or 4 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C4237943', 'cui_str': 'cabozantinib 60 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3204577', 'cui_str': 'crizotinib 250 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",152.0,0.222169,"PFS was longer in patients in the cabozantinib group (median 9·0 months, 95% CI 6-12) than in the sunitinib group (5·6 months, 3-7; hazard ratio for progression or death 0·60","[{'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA, USA. Electronic address: spal@coh.org.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tangen', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA, USA; Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'CHRISTUS Santa Rosa Medical Center Hospital, San Antonio, TX, USA.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Balzer-Haas', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Daniel Y C', 'Initials': 'DYC', 'LastName': 'Heng', 'Affiliation': 'Tom Baker Cancer Center, Calgary, AB, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Shuch', 'Affiliation': 'Institute of Urologic Oncology, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tretiakova', 'Affiliation': 'Department of Pathology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Humphrey', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Adebowale', 'Initials': 'A', 'LastName': 'Adeniran', 'Affiliation': 'Department of Pathology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Narayan', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Georg A', 'Initials': 'GA', 'LastName': 'Bjarnason', 'Affiliation': 'Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Ulka', 'Initials': 'U', 'LastName': 'Vaishampayan', 'Affiliation': 'Department of Medicine, Wayne State University, Detroit, MI, USA; Department of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ajjai', 'Initials': 'A', 'LastName': 'Alva', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Alliance for Clinical Trials in Oncology, Duke Cancer Research Institute, Durham, NC, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Cole', 'Affiliation': 'Oklahoma Cancer Specialists and Research Institute, NRG Oncology, Tulsa, OK, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Plets', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA, USA; Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Cancer Therapy Evaluation Program, Investigational Drug Branch, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Primo N', 'Initials': 'PN', 'LastName': 'Lara', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(21)00152-5']
518,33593072,Successful and Cost-Effective Facebook Recruitment: Is It Possible? Results From a Longitudinal Randomized Clinical Trial in Grandmother Caregivers.,"Facebook is often cited in health-related research as a practical option to recruit participants into research studies, but issues with recruiting verifiable and qualified participants and unpredictable costs exist. The purpose of this paper is to describe a social network theory-guided, no-cost, Facebook recruitment strategy in comparison to a traditional recruitment campaign for a national online intervention study for grandmother caregivers ( n  = 348); 211 participants were recruited via Facebook, and 137 through traditional techniques. Participation rates did not vary by recruitment method. Facebook participants were slightly older, higher income, and more likely to be white and married, but did not differ in education levels. Our strategy quickly obtained an engaged and committed participant base. The application of social network theory to traditional recruitment strategies represents a novel way for researchers to recruit through Facebook and yield viable and engaged participants without investing in Facebook ads.",2021,Participation rates did not vary by recruitment method.,"['grandmother caregivers ( n  = 348); 211 participants were recruited via Facebook, and 137 through traditional techniques', 'Grandmother Caregivers']",['Facebook'],['Participation rates'],"[{'cui': 'C0337474', 'cui_str': 'Grandmother'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],[],211.0,0.0641503,Participation rates did not vary by recruitment method.,"[{'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Wallace', 'Affiliation': '2546 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Carolyn H', 'Initials': 'CH', 'LastName': 'Still', 'Affiliation': '2546 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Jeanblanc', 'Affiliation': '2546 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Musil', 'Affiliation': '2546 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}]",International journal of aging & human development,['10.1177/0091415020987667']
519,33606419,Ultrasound assessment of gastric volumes of thick fluids: Validating a prediction model.,"BACKGROUND


Enteral nutrition is essential in the treatment of critically ill patients. Current methods to monitor enteral nutrition such as aspiration of residual volume may be inaccurate. Gastric ultrasonography estimates total gastric fluid volume using the Perlas model, but this model is validated for clear fluids only, and its accuracy for measuring thick fluids is unknown.
OBJECTIVES


The primary aim of this study was to evaluate the Perlas model for gastric volume estimation of enteral nutrition, a thick fluid product.
DESIGN


A single-centre, single blinded, randomised controlled study.
SETTING


Single university hospital, from May to July 2019.
PARTICIPANTS


Seventy-two healthy fasted volunteers were randomly allocated to different fluid volume groups.
INTERVENTION


Participants randomly ingested predetermined volumes between 50 and 400 ml of a feeding-drink (Nutricia Nutridrink). Following a standardised gastric ultrasound scanning protocol, a blinded sonographer measured the antral cross-sectional area in the supine and right-lateral decubitus positions.
MAIN OUTCOME MEASURES


Measurements were performed at baseline, 5 min postingestion and 20 min postingestion. Gastric volumes were predicted using the previously established Perlas model and compared with total gastric fluid volumes after ingestion of the study drink.
RESULTS


The Perlas model underestimated the volume of thick gastric fluid and yielded a suboptimal fit for our data. However, antral cross-sectional area and total gastric thick fluid volumes were significantly correlated (Pearson's correlation coefficient 0.73, P < 0.01). A new model was fitted to predict gastric volumes of thick fluids, using the antral cross-sectional area (cm2) in the right-lateral decubitus position: Volume (ml) = 79.38 + 13.32 x right-lateral cross-sectional area.
CONCLUSION


The Perlas model for clear gastric fluid volume estimation is suboptimal for thick fluid volume assessment and an alternative model is presented.
CLINICAL TRIAL REGISTRATION


Netherlands Trial Register Trial NL7677, Registration date: 16 April 2019; https://www.trialregister.nl/trial/7677.",2021,"However, antral cross-sectional area and total gastric thick fluid volumes were significantly correlated (Pearson's correlation coefficient 0.73, P < 0.01).","['Seventy-two healthy fasted volunteers', 'critically ill patients', 'Single university hospital, from May to July 2019']","['enteral nutrition, a thick fluid product']","['antral cross-sectional area and total gastric thick fluid volumes', 'Gastric volumes']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C3714295', 'cui_str': 'Thick fluid'}]","[{'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C3714295', 'cui_str': 'Thick fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",72.0,0.0877896,"However, antral cross-sectional area and total gastric thick fluid volumes were significantly correlated (Pearson's correlation coefficient 0.73, P < 0.01).","[{'ForeName': 'Marijn C T', 'Initials': 'MCT', 'LastName': 'Tacken', 'Affiliation': 'From the Department of Anaesthesiology, Radboudumc, Nijmegen, The Netherlands (MCTT, TAJvL, PvdP, CK), the Department of Anaesthesiology, Imeldaziekenhuis, Bonheiden, Belgium (PvdP), the Department of Anesthesia and Pain Management, Toronto Western Hospital (AP), the Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada (AP).'}, {'ForeName': 'Tristan A J', 'Initials': 'TAJ', 'LastName': 'van Leest', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van de Putte', 'Affiliation': ''}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Keijzer', 'Affiliation': ''}, {'ForeName': 'Anahi', 'Initials': 'A', 'LastName': 'Perlas', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001465']
520,33605397,Nitrous oxide as an adjunctive therapy in major depressive disorder: a randomized controlled double-blind pilot trial.,"OBJECTIVE


Major depressive disorder (MDD) is related to glutamatergic dysfunction. Antagonists of glutamatergic N-methyl-D-aspartate receptor (NMDAR), such as ketamine, have antidepressant properties. Nitrous oxide (N2O) is also a NMDAR antagonist. Thus, this study aimed to evaluate the effects of augmenting antidepressant treatment with N2O.
METHODS


This double blind, placebo-controlled randomized parallel pilot trial was conducted from June 2016 to June 2018 at the Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo. Twenty-three subjects with MDD (aged 18 to 65, on antidepressants, with a score > 17 on the 17-item-Hamilton Depression Rating Scale [HAM-D17]) received 50% N2O (n=12; 37.17±13.59 years) or placebo (100% oxygen) (n=11; 37.18±12.77 years) for 60 minutes twice a week for 4 weeks. The primary outcome was changes in HAM-D17 from baseline to week 4.
RESULTS


Depressive symptoms improved significantly in the N2O group (N2O: from 22.58±3.83 to 5.92±4.08; placebo: from 22.44±3.54 to 12.89±5.39, p < 0.005). A total of 91.7% and 75% of the N2O group subjects achieved response (≥ 50% reduction in HAM-D17 score) and remission (HAM-D17 < 7), respectively. The predominant adverse effects of N2O treatment were nausea, vomiting, and headache.
CONCLUSION


N2O treatment led to a statistically significant reduction in HAM-D17 scores compared to placebo.
CLINICAL TRIAL REGISTRATION


Brazilian Register of Clinical Trials, RBR-5rz5ch.",2021,"Depressive symptoms improved significantly in the N2O group (N2O: from 22.58±3.83 to 5.92±4.08; placebo: from 22.44±3.54 to 12.89±5.39, p < 0.005).","['major depressive disorder', 'Twenty-three subjects with MDD (aged 18 to 65, on antidepressants, with a score > 17 on the 17-item-Hamilton Depression Rating Scale [HAM-D17]) received 50% N2O ', 'June 2016 to June 2018 at the Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo']","['ketamine', 'placebo (100% oxygen', 'placebo', 'Nitrous oxide (N2O', 'glutamatergic N-methyl-D-aspartate receptor (NMDAR', 'Nitrous oxide']","['changes in HAM-D17', 'Depressive symptoms', 'nausea, vomiting, and headache', 'HAM-D17 scores', 'HAM-D17 score) and remission']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",23.0,0.412715,"Depressive symptoms improved significantly in the N2O group (N2O: from 22.58±3.83 to 5.92±4.08; placebo: from 22.44±3.54 to 12.89±5.39, p < 0.005).","[{'ForeName': 'Mara C', 'Initials': 'MC', 'LastName': 'Guimarães', 'Affiliation': 'Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Tiago M', 'Initials': 'TM', 'LastName': 'Guimarães', 'Affiliation': 'Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Jaime E', 'Initials': 'JE', 'LastName': 'Hallak', 'Affiliation': 'Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Abrão', 'Affiliation': 'Departamento de Ortopedia e Anestesiologia, Faculdade de Medicina de Ribeirão Preto, USP, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Machado-de-Sousa', 'Affiliation': 'Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (USP), Ribeirão Preto, SP, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2020-1543']
521,33600197,Motivational interviewing plus behavioral activation for alcohol misuse in college students with ADHD.,"Objective:  College is a high-risk period for the initiation and escalation of problem alcohol use. College students with attention-deficit/hyperactivity disorder (ADHD) are at particularly high risk for experiencing alcohol-related negative consequences relative to typically developing peers. Despite this, the best therapeutic approach for addressing alcohol problems in college students with ADHD has not been identified. Behavioral activation (BA) may augment the effects of gold-standard College drinking interventions [i.e., brief motivational intervention (BMI)] for students with ADHD who are engaging in problem drinking.  Method:  113 college students with ADHD (Mean age = 19.87,  SD  = 1.44; 49.1% male) were randomized to either BMI + BA or BMI plus supportive counseling (BMI + SC). Both groups received ADHD psychoeducation delivered in MI style. Outcomes were assessed using the Brief Young Adult Alcohol Consequences Questionnaire, Daily Drinking Questionnaire, Barkley Functional Impairment Scale, and Beck Depression Inventory.  Results:  There were no significant differences in outcomes for the sample as a whole; in both conditions, participants showed significant reductions in their alcohol-related negative consequences, alcohol use, and depressive symptoms at 1- and 3-month follow-ups. Exploratory moderation analyses revealed that participants with elevated depressive symptoms at baseline evidenced greater reductions in alcohol-related negative consequences in the BMI + BA condition compared to BMI + SC at the 3-month follow-up. Those low in depressive symptoms evidenced greater reductions of alcohol-related negative consequences in BMI + SC compared to BMI + BA.  Conclusions:  For college students with ADHD who reported elevated baseline depressive symptoms, the inclusion of BA with BMI resulted in significantly greater decreases in alcohol-related negative consequences, compared to BMI + SC. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"There were no significant differences in outcomes for the sample as a whole; in both conditions, participants showed significant reductions in their alcohol-related negative consequences, alcohol use, and depressive symptoms at 1- and 3-month follow-ups.","['113 college students with ADHD (Mean age = 19.87,  SD  = 1.44; 49.1% male', 'College students with attention-deficit/hyperactivity disorder (ADHD', 'college students with ADHD', 'students with ADHD who are engaging in problem drinking']","['Motivational interviewing plus behavioral activation', 'BMI + SC', 'ADHD psychoeducation delivered in MI style', 'motivational intervention (BMI', 'BMI + BA or BMI plus supportive counseling (BMI + SC']","['elevated depressive symptoms', 'Brief Young Adult Alcohol Consequences Questionnaire, Daily Drinking Questionnaire, Barkley Functional Impairment Scale, and Beck Depression Inventory', 'Behavioral activation (BA', 'alcohol-related negative consequences, alcohol use, and depressive symptoms']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3697360', 'cui_str': 'Supportive counseling'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0234518,"There were no significant differences in outcomes for the sample as a whole; in both conditions, participants showed significant reductions in their alcohol-related negative consequences, alcohol use, and depressive symptoms at 1- and 3-month follow-ups.","[{'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Meinzer', 'Affiliation': 'Department of Psychology, University of Illinois at Chicago.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Oddo', 'Affiliation': 'Department of Psychology, University of Maryland, College Park.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Vasko', 'Affiliation': 'Department of Psychology, University of Wyoming.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychology, University of Memphis.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Iwamoto', 'Affiliation': 'Department of Psychology, University of Maryland, College Park.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Lejuez', 'Affiliation': 'Department of Psychological Sciences, University of Connecticut.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Chronis-Tuscano', 'Affiliation': 'Department of Psychology, University of Maryland, College Park.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000663']
522,33608728,Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules: 12-Month Results of a Randomized Trial (LARA II Study).,"CONTEXT


Radiofrequency ablation (RFA) seems to achieve a significantly larger nodule volume reduction rate (VRR) than laser ablation (LA) in benign nonfunctioning thyroid nodules (BNTNs).
OBJECTIVE


To compare the efficacy and safety of both treatments at 12-month follow-up in patients with solid or predominantly solid BNTN.
METHODS


This was a single-center, 12-month, randomized, superiority, open-label, parallel-group trial conducted in an outpatient clinic. Sixty patients with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems were randomly assigned (1:1 ratio) to receive either a single session of RFA or LA. Twenty-9 patients per group completed the study. The main outcome measures were VRR and proportion of nodules with more than 50% reduction (technical success rate).
RESULTS


At 12 months, VRR was 70.9 ± 16.9% and 60.0 ± 19.0% in the RFA and LA groups, respectively (P = .024). This effect was confirmed in the linear regression model that was adjusted for age, sex, nodule baseline volume, and proportion of cellular components (RFA treatment: β = .390; P = .009). No significant between-group difference was observed in the technical success rate at 12 months after treatment. A statistically significant improvement was observed from the baseline to the 12-month follow-up for compression (RFA: 4.6 ± 2.6 and 1.3 ± 0.8, P < .001; and LA: 4.6 ± 2.1 and 1.6 ± 0.8, respectively, P < .001) and cosmetic (RFA: 3.4 ± 0.6 and 1.3 ± 0.5, P < .001; and LA: 3.4 ± 0.5 and 1.4 ± 0.6, P < .001) scores although the between-group differences were not significant.
CONCLUSION


RFA achieved a significantly larger nodule volume reduction at 12 months; however, the technical success rate was similar in the RFA and LA groups.",2021,"A statistically significant improvement was observed from the baseline to the 12-month follow-up for compression (RFA: 4.6 ± 2.6 and 1.3±0.8, p<0.001 and LA: 4.6 ± 2.1 and 1.6±0.8, respectively, p<0.001) and cosmetic (RFA: 3.4±0.6 and 1.3±0.5, p<0.001 and LA: 3.4±0.5 and 1.4±0.6, p<0.001) scores although the between-group differences were not significant.
","['thyroid nodules', '29 patients per group completed the study', 'Sixty patients with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems', 'Outpatient clinic', 'patients with solid or predominantly solid BNTN']","['Laser Ablation versus Radiofrequency Ablation', 'RFA', 'RFA or LA', 'laser ablation (LA', 'Radiofrequency ablation (RFA']","['nodule volume reduction', 'efficacy and safety', 'technical success rate', 'VRR and proportion of nodules', 'VRR']","[{'cui': 'C0040137', 'cui_str': 'Thyroid nodule'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205208', 'cui_str': 'Solid'}]","[{'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449851', 'cui_str': 'Technique'}]",60.0,0.0545908,"A statistically significant improvement was observed from the baseline to the 12-month follow-up for compression (RFA: 4.6 ± 2.6 and 1.3±0.8, p<0.001 and LA: 4.6 ± 2.1 and 1.6±0.8, respectively, p<0.001) and cosmetic (RFA: 3.4±0.6 and 1.3±0.5, p<0.001 and LA: 3.4±0.5 and 1.4±0.6, p<0.001) scores although the between-group differences were not significant.
","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cesareo', 'Affiliation': 'Unit of metabolic diseases, ""S. M. Goretti"" Hospital, Latina, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Manfrini', 'Affiliation': 'Unit of Endocrinology and Diabetes, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Pasqualini', 'Affiliation': 'Department of Radiology, ""S. M. Goretti"" Hospital, Latina, Italy.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Ambrogi', 'Affiliation': 'Department of Radiology, ""S. M. Goretti"" Hospital, Latina, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Sanson', 'Affiliation': 'Clinical Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gallo', 'Affiliation': 'Department of Sense Organs, Sapienza University of Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pozzilli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Pedone', 'Affiliation': 'Geriatric Unit, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Crescenzi', 'Affiliation': 'Unit of Pathology, University Hospital Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Palermo', 'Affiliation': 'Unit of Endocrinology and Diabetes, Campus Bio-Medico University, Rome, Italy.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab102']
523,33610836,Predictors of Visual Acuity Outcomes after Anti-Vascular Endothelial Growth Factor Treatment for Macular Edema Secondary to Central Retinal Vein Occlusion.,"PURPOSE


To evaluate whether baseline demographic, clinical, and OCT characteristics predict visual acuity (VA) outcomes in patients receiving anti-vascular endothelial growth factor (VEGF) therapy for macular edema (ME) due to central retinal vein occlusion (CRVO).
DESIGN


Post hoc analysis of the randomized noninferiority trial (Lucentis, Eylea, Avastin in CRVO) LEAVO Study from December 12, 2014, to December 16, 2016, carried out across 44 UK National Health Service ophthalmology departments.
PARTICIPANTS


Data on 267 participants with a baseline best-corrected mean visual acuity (BCVA) range of 19 to 78 Early Treatment Diabetic Retinopathy Study letter score (approximate Snellen equivalent, 20/32 to 20/320) who had central subfield thickness (CST) ≥ 320 μm on Spectralis OCT (Heidelberg Engineering) were analyzed.
METHODS


Study participants were randomized to receive repeated intravitreal injections of ranibizumab (0.5 mg/50 μl), aflibercept (2.0 mg/50 μl), or bevacizumab (1.25 mg/50 μl), and a protocol-driven pro re nata re-treatment regimen at 4 to 8 weekly visits was followed up to week 100 after 4 mandated 4-weekly loading injections.
MAIN OUTCOME MEASURES


Change in BCVA and percentage of patients gaining ≥ 10 letters and achieving BCVA letter score > 70 letters at 52 and 100 weeks.
RESULTS


The analysis was adjusted for treatment effects and confirmed by sensitivity analysis. Age ≥ 75 years is a poor predictor for all 3 visual outcomes. Lower baseline BCVA predicted 10-letter gainers and higher gains in BCVA, although it is a poor predictor of achieving > 70 Early Treatment Diabetic Retinopathy Study letters. None of the baseline OCT morphologic characteristics except ellipsoid zone (EZ) integrity influenced any visual outcomes. Both baseline CST and total macular volume showed a nonlinear relation to 10-letter gainers, with CST > 900 μm being a poor prognostic indicator. Baseline CST and macular volume did not predict mean change in BCVA or BCVA > 70 letters at 52 and 100 weeks. The sensitivity analysis conclusions after removing iCRVO were similar.
CONCLUSIONS


At presentation, younger age, higher baseline BCVA, and a definitely intact subfoveal EZ are predictors of BCVA score > 70 letters at 100 weeks.",2021,"Baseline CST and macular volume did not predict mean change in BCVA or BCVA>70 letters at 52 and 100 weeks.
","['CRVO) - LEAVO Study from December 12, 2014, through December 16, 2016 carried out across 44 UK National Health Service ophthalmology departments', 'patients receiving anti-VEGF therapy for ME (macular edema) due to CRVO (central retinal vein occlusion', 'macular edema secondary to central retinal vein occlusion', 'Data on 267 participants with baseline best corrected mean visual acuity (BCVA) range of 19-78 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximate Snellen equivalent, 20/32 to 20/320) who had central subfield thickness (CST) ≥ 320μm on Spectralis OCT (Heidelberg Engineering, Germany) were analysed']","['optical coherence tomography (OCT', 'ranibizumab [0.5mg/50μl], aflibercept [2.0mg/50μl] or bevacizumab [1.25-mg/50μl], and a protocol driven pro-re-nata (PRN) re-treatment regimen', 'anti-VEGF treatment']","['Change in BCVA, percentage of patients gaining ≥ 10 letters and achieving BCVA letter score', 'Baseline CST and macular volume', 'total macular volume', 'visual acuity outcomes']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0587524', 'cui_str': 'Ophthalmology department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4727874', 'cui_str': 'Anti-VEGF therapy'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0154841', 'cui_str': 'Central retinal vein occlusion'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0014279', 'cui_str': 'Engineering'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",267.0,0.415504,"Baseline CST and macular volume did not predict mean change in BCVA or BCVA>70 letters at 52 and 100 weeks.
","[{'ForeName': 'Piyali', 'Initials': 'P', 'LastName': 'Sen', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, London, United Kingdom; UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Sarega', 'Initials': 'S', 'LastName': 'Gurudas', 'Affiliation': 'UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Ramu', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, London, United Kingdom.'}, {'ForeName': 'Namritha', 'Initials': 'N', 'LastName': 'Patrao', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, London, United Kingdom.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Chandra', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, London, United Kingdom; UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Rajna', 'Initials': 'R', 'LastName': 'Rasheed', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, London, United Kingdom.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Nicholson', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, London, United Kingdom.'}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': ""NetwORC UK Reading Centre, Queen's University of Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, London, United Kingdom; UCL Institute of Ophthalmology, London, United Kingdom. Electronic address: Sobha.sivaprasad@nhs.net.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hykin', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, London, United Kingdom; UCL Institute of Ophthalmology, London, United Kingdom.'}]",Ophthalmology. Retina,['10.1016/j.oret.2021.02.008']
524,33612068,"The GÖTEBORG prostate cancer screening 2 trial: a prospective, randomised, population-based prostate cancer screening trial with prostate-specific antigen testing followed by magnetic resonance imaging of the prostate.","OBJECTIVE


To describe the study design of the GÖTEBORG prostate cancer screening (PC) 2 (Göteborg-2), a prospective, randomised, population-based trial of PC screening. This trial evaluates whether prostate-specific antigen (PSA) testing followed by 3 Tesla prostate magnetic resonance imaging (MRI) and targeted biopsy can reduce overdiagnosis, while maintaining the detection of clinically significant cancer, compared to PSA-screening and systematic biopsy.
MATERIALS AND METHODS


A random sample of men 50-60 years in the Göteborg area, Sweden, identified from the Total Population Register, were randomised to either a screening or control group (CG). Participants in the screening group (SG) were further randomised into one of three arms: (1) PSA-test; if PSA ≥ 3 ng/mL, then MRI and systematic biopsy, plus targeted biopsy to suspicious lesions as per Prostate Imaging - Reporting and Data System, version 2 (PI-RADSv2) 3-5; (2) PSA-test; if PSA ≥ 3 ng/mL, then MRI, and targeted biopsy only if PI-RADSv2 3-5; (3) identical to Arm 2, except lower PSA-cut-off ≥1.8 ng/mL. The primary outcome is the detection rate of clinically insignificant PC (defined as Gleason Score 3 + 3 [Grade Group 1]) comparing all men with PSA ≥ 3 ng/mL in Arm 1  vs.  Arm 2 + 3.
RESULTS


Randomisation and enrolment started in September 2015. Accrual has hitherto resulted in 38,770 men randomised to the SG. The participation rate is 50%. Invitation to the first screening round was completed in June 2020.
CONCLUSIONS


The Göteborg-2 trial will provide new knowledge about the performance of prostate MRI in a screening setting.",2021,"Participants in the screening group (SG) were further randomised into one of three arms: (1) PSA-test; if PSA ≥ 3 ng/mL, then MRI and systematic biopsy, plus targeted biopsy to suspicious lesions as per Prostate Imaging - Reporting and Data System, version 2 (PI-RADSv2) 3-5; (2) PSA-test; if PSA ≥ 3 ng/mL, then MRI, and targeted biopsy only if PI-RADSv2 3-5; (3) identical to Arm 2, except lower PSA-cut-off ≥1.8 ng/mL.","['men 50-60\xa0years in the Göteborg area, Sweden, identified from the Total Population Register', 'Participants in the screening group (SG', '38,770 men randomised to the SG']","['prostate-specific antigen (PSA) testing followed by 3 Tesla prostate magnetic resonance imaging (MRI) and targeted biopsy', 'screening or control group (CG']","['participation rate', 'detection rate of clinically insignificant PC']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032681', 'cui_str': 'Population Register'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",,0.258803,"Participants in the screening group (SG) were further randomised into one of three arms: (1) PSA-test; if PSA ≥ 3 ng/mL, then MRI and systematic biopsy, plus targeted biopsy to suspicious lesions as per Prostate Imaging - Reporting and Data System, version 2 (PI-RADSv2) 3-5; (2) PSA-test; if PSA ≥ 3 ng/mL, then MRI, and targeted biopsy only if PI-RADSv2 3-5; (3) identical to Arm 2, except lower PSA-cut-off ≥1.8 ng/mL.","[{'ForeName': 'Kimia', 'Initials': 'K', 'LastName': 'Kohestani', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Arnsrud Godtman', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Stranne', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Wallström', 'Affiliation': 'Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Carlsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Hellström', 'Affiliation': 'Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Scandinavian journal of urology,['10.1080/21681805.2021.1881612']
525,33620233,Adiponectin gene variant rs266729 interacts with different macronutrient distributions of two different hypocaloric diets during nine months.,"Introduction


Background: the role of ADIPOQ gene variants on metabolic changes after weight loss secondary to different hypocaloric diets remains unclear and poorly investigated. Objective: we evaluated the effect of polymorphism rs266729 of ADIPOQ gene on biochemical changes and weight loss after a high-protein/low-carbohydrate diet vs a standard severe hypocaloric diet during 9 months. Material and methods: a population of 269 obese patients was enrolled in a randomized intervention trial for 9 months with two diets. Diet HP (high protein) was 33 % of carbohydrates (86.1 g/day), 33 % of fat (39.0 g/day), and 34 % of proteins (88.6 g/day). Diet S (standard) was 1093 cal/day, 53 % carbohydrates (144.3 g/day), 27 % fats (32.6 g), and 20 % proteins (55.6 g/day). Before and after the intervention an anthropometric evaluation, an assessment of nutritional intake, and a biochemical analysis were carried out. Results: all patients lost weight regardless of genotype and diet. After the intervention with a high protein hypocaloric diet (diet HP) only subjects with CC genotype showed significant improvement in cholesterol (14.4 ± 1.8 md/dL vs -5.0 ± 1.9 mg/dL; p = 0.02), LDL-cholesterol (14.4 ± 1.9 mg/dL vs -5.1 ± 1.8 mg/dL; p = 0.01), insulin (-4.1 ± 0.3 mU/L vs -2.0 ± 0.6 mU/L; p = 0.02), HOMA-IR (-1.4 ± 0.2 units vs -0.5 ± 0.3 units; p = 0.02) and adiponectin (10.2 ± 1.4 ng/dL vs 3.1 ± 1.1 ng/dL; p = 0.01) levels. After the second dietary strategy with a standard hypocaloric diet (diet S) only subjects with CC genotype showed significant improvement in total cholesterol (CC vs CG + GG) (-17.1 ± 1.9 md/dL vs -5.3 ± 1.3 mg/dL; p = 0.02), LDL-cholesterol (-12.3 ± 1.9 mg/dL vs -8.0 ± 1.2 mg/dL; p = 0.01), insulin (-4.0 ± 0.9 mU/L vs -1.3 ± 0.5 mU/L; p = 0.02), HOMA-IR (-1.2 ± 0.1 units vs -0.6 ± 0.2 units; p = 0.02), and adiponectin (11.1 ± 2.7 ng/dL vs 3.3 ± 1.2 ng/dL; p = 0.02) levels. Conclusion: non G-allele carriers showed a better response of LDL-cholesterol, HOMA-IR, insulin, and adiponectin levels than G-allele carriers before weight loss with both diets.",2021,After the intervention with a high protein hypocaloric diet (diet HP) only subjects with CC genotype showed significant improvement in cholesterol (14.4 ± 1.8 md/dL,['a population of 269 obese patients'],"['Diet HP (high protein', 'high protein hypocaloric diet (diet HP']","['HOMA-IR', 'adiponectin', 'response of LDL-cholesterol, HOMA-IR, insulin, and adiponectin levels', 'cholesterol', 'LDL-cholesterol', 'total cholesterol']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",269.0,0.0294475,After the intervention with a high protein hypocaloric diet (diet HP) only subjects with CC genotype showed significant improvement in cholesterol (14.4 ± 1.8 md/dL,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'de Luis', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Facultad de Medicina. Servicio de Endocrinología y Nutrición. Hospital Universitario Río Hortega.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo Martín', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Facultad de Medicina. Servicio de Endocrinología y Nutrición. Hospital Universitario Río Hortega.'}, {'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Facultad de Medicina. Servicio de Endocrinología y Nutrición. Hospital Universitario Río Hortega.'}]",Nutricion hospitalaria,['10.20960/nh.03423']
526,33604696,Acute mental stress-caused arterial stiffening can be counteracted by brief aerobic exercise.,"PURPOSE


Acute mental stress (MS) causes an elevation in pulse wave velocity (PWV), an index of arterial stiffness. In contrast, aerobic exercise acutely decreases arterial stiffness, even in the short term. The present study aimed to examine whether acute MS-caused arterial stiffening can be counteracted by brief aerobic exercise.
METHODS


Thirteen young healthy men (mean age, 20 ± 1 years) participated in two randomized experimental visits where they were subjected to acute MS followed by seated rest (RE) or cycling exercise (EX) trials. Following a 5-min MS task, the participants in the RE trial rested on a chair for 10 min (from 10 to 20 min after the cessation of the task), whereas those in the EX trial cycled at 35% of heart rate reserve for the same duration. Heart-brachial PWV (hbPWV), brachial-ankle PWV (baPWV), heart-ankle PWV (haPWV), and the cardio-ankle vascular index (CAVI) were simultaneously measured at baseline and 5, 30, and 45 min after the task.
RESULTS


Both trials caused significant elevations (P < 0.05) in hbPWV, haPWV, and CAVI at 5 min after the task; subsequently, this persisted until 45 min after the task in the RE trial, whereas the elevations in the EX trial were eliminated. In the RE trial, baPWV significantly increased (P < 0.05) at 30 and 45 min after the task, whereas such an increase was not observed in the EX trial.
CONCLUSION


The findings of the present study reveal that brief aerobic exercise counteracts arterial stiffening caused by acute MS.",2021,"Both trials caused significant elevations (P < 0.05) in hbPWV, haPWV, and CAVI at 5 min after the task; subsequently, this persisted until 45 min after the task in the RE trial, whereas the elevations in the EX trial were eliminated.","['Thirteen young healthy men (mean age, 20\u2009±\u20091\xa0years']","['aerobic exercise', 'acute MS followed by seated rest (RE) or cycling exercise (EX']","['arterial stiffness', 'pulse wave velocity (PWV), an index of arterial stiffness', 'hbPWV, haPWV, and CAVI', 'baPWV', 'Heart-brachial PWV (hbPWV), brachial-ankle PWV (baPWV), heart-ankle PWV (haPWV), and the cardio-ankle vascular index (CAVI']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}, {'cui': 'C1096531', 'cui_str': 'Brachial pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}]",13.0,0.0779572,"Both trials caused significant elevations (P < 0.05) in hbPWV, haPWV, and CAVI at 5 min after the task; subsequently, this persisted until 45 min after the task in the RE trial, whereas the elevations in the EX trial were eliminated.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kume', 'Affiliation': 'Department of Health, Sports and Welfare, Okinawa University, 555 Kokuba, Naha, Okinawa, 902-8521, Japan. kumedai128@gmail.com.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nishiwaki', 'Affiliation': 'Faculty of Engineering, Osaka Institute of Technology, 5-16-1 Omiya, Asahi-ku, Osaka, 535-8585, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Hotta', 'Affiliation': 'Department of Lifelong Sports and Health Sciences, Chubu University, 1200 Matsumoto-cho, Kasugai, Aichi, 487-8501, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Endoh', 'Affiliation': 'Department of Health and Physical Education, University of the Ryukyus, 1 Senbaru, Nishihara, Okinawa, 903-0213, Japan.'}]",European journal of applied physiology,['10.1007/s00421-021-04618-3']
527,33608048,Modulation of atypical brain activation during executive functioning in autism: a pharmacological MRI study of tianeptine.,"BACKGROUND


Autism spectrum disorder (ASD) is associated with deficits in executive functioning (EF), and these have been suggested to contribute to core as well as co-occurring psychiatric symptoms. The biological basis of these deficits is unknown but may include the serotonergic system, which is involved both in regulating EF in neurotypical populations and in the pathophysiology of ASD. We previously demonstrated that reducing serotonin by acute tryptophan depletion (ATD) shifts differences in brain function during performance of EF tasks towards control levels. However, ATD cannot be easily used in the clinic, and we therefore need to adopt alternative approaches to challenge the serotonin system. Hence, we investigated the role of the serotonergic modulator tianeptine on EF networks in ASD.
METHOD


We conducted a pharmacological magnetic resonance imaging study, using a randomized double-blind crossover design, to compare the effect of an acute dosage of 12.5 mg tianeptine and placebo on brain activation during two EF tasks (of response inhibition and sustained attention) in 38 adult males: 19 with ASD and 19 matched controls.
RESULTS


Under placebo, compared to controls, individuals with ASD had atypical brain activation in response inhibition regions including the inferior frontal cortex, premotor regions and cerebellum. During sustained attention, individuals with ASD had decreased brain activation in the right middle temporal cortex, right cuneus and left precuneus. Most of the case-control differences in brain function observed under placebo conditions were abolished by tianeptine administration. Also, within ASD individuals, brain functional differences were shifted significantly towards control levels during response inhibition in the inferior frontal and premotor cortices.
LIMITATIONS


We conducted a pilot study using a single dose of tianeptine, and therefore, we cannot comment on long-term outcome.
CONCLUSIONS


Our findings provide the first evidence that tianeptine can shift atypical brain activation during EF in adults with ASD towards control levels. Future studies should investigate whether this shift in the biology of ASD is maintained after prolonged treatment with tianeptine and whether it improves clinical symptoms.",2021,", individuals with ASD had atypical brain activation in response inhibition regions including the inferior frontal cortex, premotor regions and cerebellum.","['Autism spectrum disorder (ASD', '38 adult males: 19 with ASD and 19 matched controls', 'adults with ASD', 'autism']","['tianeptine and placebo', 'tianeptine', 'placebo']","['brain function', 'brain activation', 'atypical brain activation']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0076652', 'cui_str': 'tianeptine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}]",38.0,0.15437,", individuals with ASD had atypical brain activation in response inhibition regions including the inferior frontal cortex, premotor regions and cerebellum.","[{'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Wichers', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, The Sackler Centre for Translational Neurodevelopment, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO50 De Crespigny Park, Denmark Hill, London, SE5 8AF, UK. rob.wichers@kcl.ac.uk.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Findon', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, The Sackler Centre for Translational Neurodevelopment, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO50 De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Auke', 'Initials': 'A', 'LastName': 'Jelsma', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, The Sackler Centre for Translational Neurodevelopment, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO50 De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Giampietro', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vladimira', 'Initials': 'V', 'LastName': 'Stoencheva', 'Affiliation': 'Behavioural and Developmental Psychiatry Clinical Academic Group, South London and Maudsley NHS Trust, London, UK.'}, {'ForeName': 'Dene M', 'Initials': 'DM', 'LastName': 'Robertson', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, The Sackler Centre for Translational Neurodevelopment, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO50 De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Clodagh M', 'Initials': 'CM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, The Sackler Centre for Translational Neurodevelopment, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO50 De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blainey', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, The Sackler Centre for Translational Neurodevelopment, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO50 De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Grainne', 'Initials': 'G', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, The Sackler Centre for Translational Neurodevelopment, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO50 De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ecker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt am Main, Goethe-University, Frankfurt am Main, Germany.'}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Rubia', 'Affiliation': ""Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Declan G M', 'Initials': 'DGM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, The Sackler Centre for Translational Neurodevelopment, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO50 De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, The Sackler Centre for Translational Neurodevelopment, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO50 De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}]",Molecular autism,['10.1186/s13229-021-00422-0']
528,33620330,A Digital Health Intervention (SweetGoals) for Young Adults With Type 1 Diabetes: Protocol for a Factorial Randomized Trial.,"BACKGROUND


Many young adults with type 1 diabetes (T1D) struggle with the complex daily demands of adherence to their medical regimen and fail to achieve target range glycemic control. Few interventions, however, have been developed specifically for this age group.
OBJECTIVE


In this randomized trial, we will provide a mobile app (SweetGoals) to all participants as a ""core"" intervention. The app prompts participants to upload data from their diabetes devices weekly to a device-agnostic uploader (Glooko), automatically retrieves uploaded data, assesses daily and weekly self-management goals, and generates feedback messages about goal attainment. Further, the trial will test two unique intervention components: (1) incentives to promote consistent daily adherence to goals, and (2) web health coaching to teach effective problem solving focused on personalized barriers to self-management. We will use a novel digital direct-to-patient recruitment method and intervention delivery model that transcends the clinic.
METHODS


A 2x2 factorial randomized trial will be conducted with 300 young adults ages 19-25 with type 1 diabetes and (Hb)A 1c  ≥ 8.0%. All participants will receive the SweetGoals app that tracks and provides feedback about two adherence targets: (a) daily glucose monitoring; and (b) mealtime behaviors. Participants will be randomized to the factorial combination of incentives and health coaching. The intervention will last 6 months. The primary outcome will be reduction in A 1c . Secondary outcomes include self-regulation mechanisms in longitudinal mediation models and engagement metrics as a predictor of outcomes. Participants will complete 6- and 12-month follow-up assessments. We hypothesize greater sustained A 1c  improvements in participants who receive coaching and who receive incentives compared to those who do not receive those components.
RESULTS


Data collection is expected to be complete by February 2025. Analyses of primary and secondary outcomes are expected by December 2025.
CONCLUSIONS


Successful completion of these aims will support dissemination and effectiveness studies of this intervention that seeks to improve glycemic control in this high-risk and understudied population of young adults with T1D.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04646473; https://clinicaltrials.gov/ct2/show/NCT04646473.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/27109.",2021,"We hypothesize greater sustained A 1c  improvements in participants who receive coaching and who receive incentives compared to those who do not receive those components.
","['young adults with type 1 diabetes (T1D', '300 young adults ages 19-25 with type 1 diabetes and (Hb)A 1c  ≥ 8.0', 'Young Adults With Type 1 Diabetes']","['Digital Health Intervention (SweetGoals', 'incentives and health coaching']","['self-regulation mechanisms in longitudinal mediation models and engagement metrics as a predictor of outcomes', 'reduction in A 1c ']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",300.0,0.166449,"We hypothesize greater sustained A 1c  improvements in participants who receive coaching and who receive incentives compared to those who do not receive those components.
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stanger', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, United States.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kowatsch', 'Affiliation': 'Centre for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, United States.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Lim-Liberty', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, United States.'}, {'ForeName': 'Prabhakaran', 'Initials': 'P', 'LastName': 'Santhanam', 'Affiliation': 'Centre for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kaden', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, United States.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Rosenberg', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, United States.'}]",JMIR research protocols,['10.2196/27109']
529,33608568,Effect of noisy galvanic vestibular stimulation on dynamic posture sway under visual deprivation in patients with bilateral vestibular hypofunction.,"A single-blind study to investigate the effects of noisy galvanic vestibular stimulation (nGVS) in straight walking and 2 Hz head yaw walking for healthy and bilateral vestibular hypofunction (BVH) participants in light and dark conditions. The optimal stimulation intensity for each participant was determined by calculating standing stability on a force plate while randomly applying six graded nGVS intensities (0-1000 µA). The chest-pelvic (C/P) ratio and lateral deviation of the center of mass (COM) were measured by motion capture during straight and 2 Hz head yaw walking in light and dark conditions. Participants were blinded to nGVS served randomly and imperceivably. Ten BVH patients and 16 healthy participants completed all trials. In the light condition, the COM lateral deviation significantly decreased only in straight walking (p = 0.037) with nGVS for the BVH. In the dark condition, both healthy (p = 0.026) and BVH (p = 0.017) exhibited decreased lateral deviation during nGVS. The C/P ratio decreased significantly in BVH for 2 Hz head yaw walking with nGVS (p = 0.005) in light conditions. This study demonstrated that nGVS effectively reduced walking deviations, especially in visual deprived condition for the BVH. Applying nGVS with different head rotation frequencies and light exposure levels may accelerate the rehabilitation process for patients with BVH.Clinical Trial Registration This clinical trial was prospectively registered at www.clinicaltrials.gov with the Unique identifier: NCT03554941. Date of registration: (13/06/2018).",2021,"In the light condition, the COM lateral deviation significantly decreased only in straight walking (p = 0.037) with nGVS for the BVH.","['healthy and bilateral vestibular hypofunction (BVH) participants in light and dark conditions', 'Ten BVH patients and 16 healthy participants completed all trials', 'patients with BVH.Clinical Trial Registration', 'patients with bilateral vestibular hypofunction']","['straight walking and 2\xa0Hz head yaw walking', 'noisy galvanic vestibular stimulation', 'noisy galvanic vestibular stimulation (nGVS', 'nGVS']","['chest-pelvic (C/P) ratio and lateral deviation of the center of mass (COM', 'lateral deviation', 'walking deviations', 'straight walking', 'dynamic posture sway under visual deprivation', 'COM lateral deviation', 'BVH']","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0043388', 'cui_str': 'Yaws'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]",,0.054312,"In the light condition, the COM lateral deviation significantly decreased only in straight walking (p = 0.037) with nGVS for the BVH.","[{'ForeName': 'Po-Yin', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University, Taipei, 11221, Taiwan.'}, {'ForeName': 'Ying-Chun', 'Initials': 'YC', 'LastName': 'Jheng', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University, Taipei, 11221, Taiwan.'}, {'ForeName': 'Chien-Chih', 'Initials': 'CC', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, 11221, Taiwan.'}, {'ForeName': 'Shih-En', 'Initials': 'SE', 'LastName': 'Huang', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University, Taipei, 11221, Taiwan.'}, {'ForeName': 'Ting-Hua', 'Initials': 'TH', 'LastName': 'Yang', 'Affiliation': 'Department of Otolaryngology, College of Medicine, National Taiwan University, Taipei, 106216, Taiwan.'}, {'ForeName': 'Po-Cheng', 'Initials': 'PC', 'LastName': 'Hsu', 'Affiliation': 'Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taipei, 10845, Taiwan.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Kuo', 'Affiliation': 'Department of Sports Sciences, University of Taipei, Taipei, 11153, Taiwan.'}, {'ForeName': 'Yi-Ying', 'Initials': 'YY', 'LastName': 'Lin', 'Affiliation': 'School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, 11221, Taiwan.'}, {'ForeName': 'Wei-Yi', 'Initials': 'WY', 'LastName': 'Lai', 'Affiliation': 'School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, 11221, Taiwan.'}, {'ForeName': 'Chung-Lan', 'Initials': 'CL', 'LastName': 'Kao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, 11217, Taiwan. clkao@vghtpe.gov.tw.'}]",Scientific reports,['10.1038/s41598-021-83206-z']
530,33606009,Doxycycline Versus Azithromycin for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men: A Randomized Controlled Trial.,"BACKGROUND


Azithromycin and doxycycline are both recommended treatments for rectal Chlamydia trachomatis (CT) infection, but observational studies suggest that doxycycline may be more effective.
METHODS


This randomized, double-blind, placebo-controlled trial compared azithromycin (single 1-g dose) versus doxycycline (100 mg twice daily for 7 days) for the treatment of rectal CT in men who have sex with men (MSM) in Seattle and Boston. Participants were enrolled after a diagnosis of rectal CT in clinical care and underwent repeated collection of rectal swabs for nucleic acid amplification testing (NAAT) at study enrollment and 2 weeks and 4 weeks postenrollment. The primary outcome was microbiologic cure (CT-negative NAAT) at 4 weeks. The complete case (CC) population included participants with a CT-positive NAAT at enrollment and a follow-up NAAT result; the intention-to-treat (ITT) population included all randomized participants.
RESULTS


Among 177 participants enrolled, 135 (76%) met CC population criteria for the 4-week follow-up visit. Thirty-three participants (19%) were excluded because the CT NAAT repeated at enrollment was negative. Microbiologic cure was higher with doxycycline than azithromycin in both the CC population (100% [70 of 70] vs 74% [48 of 65]; absolute difference, 26%; 95% confidence interval [CI], 16-36%; P < .001) and the ITT population (91% [80 of 88] vs 71% [63 of 89]; absolute difference, 20%; 95% CI, 9-31%; P < .001).
CONCLUSIONS


A 1-week course of doxycycline was significantly more effective than a single dose of azithromycin for the treatment of rectal CT in MSM.
CLINICAL TRIALS REGISTRATION


NCT03608774.",2021,"Microbiologic cure was higher with doxycycline than azithromycin in both the CC population [100% (70 of 70) vs. 74% (48 of 65); absolute difference 26% (95% CI: 16-36%; p<0.001)] and the ITT population [91% (80 of 88) vs. 71% (63 of 89); absolute difference 20% (95% CI: 9-31%; p<0.001)].
","['Men who have Sex with Men', 'Participants were enrolled after a diagnosis of rectal CT in clinical care and underwent', 'men who have sex with men (MSM) in Seattle and Boston', 'Thirty-three participants (19%) were excluded because the CT NAAT repeated at enrollment was negative', '177 participants enrolled, 135 (76%) met CC population criteria for the four-week follow-up visit', 'participants with a CT-positive NAAT at enrollment and a follow-up NAAT result; the intention-to-treat (ITT) population included all randomized participants']","['placebo', 'DoDoxycycline Versus Azithromycin', 'Azithromycin and doxycycline', 'azithromycin', 'doxycycline', 'repeated collection of rectal swabs for nucleic acid amplification testing (NAAT']","['Microbiologic cure', 'Rectal Chlamydia', 'microbiologic cure (CT-negative NAAT']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0444215', 'cui_str': 'Rectal swab'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",177.0,0.652723,"Microbiologic cure was higher with doxycycline than azithromycin in both the CC population [100% (70 of 70) vs. 74% (48 of 65); absolute difference 26% (95% CI: 16-36%; p<0.001)] and the ITT population [91% (80 of 88) vs. 71% (63 of 89); absolute difference 20% (95% CI: 9-31%; p<0.001)].
","[{'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Dombrowski', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Wierzbicki', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland, USA.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Newman', 'Affiliation': 'Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Powell', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Dwyn', 'Initials': 'D', 'LastName': 'Dithmer', 'Affiliation': 'HIV/STD Program, Public Health-Seattle & King County, Seattle, Washington, USA.'}, {'ForeName': 'Olusegun O', 'Initials': 'OO', 'LastName': 'Soge', 'Affiliation': 'Departments of Medicine and Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'Fenway Health, Boston, Massachusetts, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab153']
531,33604801,Effect of exercise on sleep and cardiopulmonary parameters in patients with pulmonary artery hypertension.,"BACKGROUND


Pulmonary arterial hypertension (PAH) is considered to be a rare progressive disease resulting from restricted flow through the pulmonary arterial circulation resulting ultimately in right-sided heart failure. Most patients with PAH suffer from sleep disorders, reduced aerobic fitness, and mortality risk despite optimized medical treatment. This study investigated the effect of 12 weeks of aerobic training on sleep quality, sleep efficiency, right ventricular systolic pressure (RVSP), and aerobic fitness in patients with PAH.
METHODS


Thirty patients with PAH were randomized to two equal groups, training group (A) and control group (B). The Pittsburg sleep quality index (PSQI) questionnaire and a wrist-worn actigraph were used for the assessment of sleep quality and sleep efficiency respectively. RVSP was measured using echocardiography. Cardiopulmonary exercise testing (CPET) assessed maximal heart rate and VO2max. All were measured before and after the study period for both groups. Exercise training was conducted on a bicycle ergometer as an individually-tailored moderate-intensity aerobic training session (60 to 70% of the maximal heart rate reached during the initial exercise test) for 30 to 45 min/day, 3 sessions/week for 12 weeks (36 sessions).
RESULTS


Sleep scores and RVSP showed significant reductions and VO2max-representing the aerobic fitness-showed a significant increase in the group (A) compared with group (B).
CONCLUSION


These results suggest that aerobic training has a positive effect on three risk factors for mortality in patients with PAH, namely sleep quality, decline in exercise capacity, and right ventricular remodeling.
CLINICAL TRIALS REGISTRATION


Clinical trial registered in ClinicalTrials.gov , ID: NCT04337671.",2021,"RESULTS


Sleep scores and RVSP showed significant reductions and VO2max-representing the aerobic fitness-showed a significant increase in the group (A) compared with group (B).
","['patients with PAH', 'patients with pulmonary artery hypertension', 'Thirty patients\xa0with PAH', 'patients with\xa0PAH']","['Cardiopulmonary exercise testing (CPET', 'exercise', 'aerobic training', 'bicycle ergometer as an individually-tailored moderate-intensity aerobic training\xa0session', 'Exercise training']","['sleep quality, sleep efficiency, right ventricular systolic pressure (RVSP), and aerobic fitness', 'maximal heart\xa0rate and VO2max', 'sleep and cardiopulmonary parameters', 'RVSP', 'Pittsburg sleep quality index (PSQI) questionnaire and a wrist-worn actigraph', 'aerobic fitness, and mortality risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0456181', 'cui_str': 'Right ventricular systolic pressure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0261602,"RESULTS


Sleep scores and RVSP showed significant reductions and VO2max-representing the aerobic fitness-showed a significant increase in the group (A) compared with group (B).
","[{'ForeName': 'Hady', 'Initials': 'H', 'LastName': 'Atef', 'Affiliation': 'Faculty of physical therapy, Cairo University, Cairo, Egypt. hady612@hotmail.com.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Abdeen', 'Affiliation': 'Faculty of physical therapy, Cairo University, Cairo, Egypt.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02286-9']
532,33604731,Relationship between parent perception of child anthropometric phenotype and body mass index change among children with developmental disabilities.,"BACKGROUND


Preschool-age children with developmental disabilities (DD) have higher prevalence of obesity than children without DD. This study aimed to explore the relationship between parent perception of their children's anthropometric phenotype and child body mass index (BMI) z score change over one school year among preschoolers with DD.
METHODS


The analysis consisted of a subsample (N  =  64) of children with DD from a larger randomized controlled trial to test an obesity prevention program in the childcare center setting. Parents ranks their child's anthropometric phenotype on a visual silhouette chart on a scale from 1 (underweight) to 7 (obese) and that rank score is compared to their BMI z score change over one school year.
RESULTS


The majority (75%) of parents with an obese child underestimated their child's anthropometric phenotype while 7% parents with a non-obese child overestimated. Parent overestimation of child anthropometric phenotype status is associated with increased BMI z score change over 1 school year among preschool-age children with disabilities.
CONCLUSION


Parental overestimation of child anthropometric phenotype status was associated with weight gain in preschool children with DD after one school year.",2021,"CONCLUSION


Parental overestimation of child anthropometric phenotype status was associated with weight gain in preschool children with DD after one school year.","['children with developmental disabilities', 'preschool children with DD after one school year', 'Preschool-age children with developmental disabilities (DD']",['obesity prevention program'],"['weight gain', 'BMI z score change', ""parent perception of their children's anthropometric phenotype and child body mass index (BMI) z score change""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",,0.0302104,"CONCLUSION


Parental overestimation of child anthropometric phenotype status was associated with weight gain in preschool children with DD after one school year.","[{'ForeName': 'Lu-Yu', 'Initials': 'LY', 'LastName': 'Xie', 'Affiliation': 'University of Texas Health Science Center at Houston, School of Public Health, Dallas Campus, Dallas, TX, USA.'}, {'ForeName': 'Folefac D', 'Initials': 'FD', 'LastName': 'Atem', 'Affiliation': 'University of Texas Health Science Center at Houston, School of Public Health, Dallas Campus, Dallas, TX, USA.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Bar', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Matthew Sunil', 'Initials': 'MS', 'LastName': 'Mathew', 'Affiliation': 'University of Texas Health Science Center at Houston, School of Public Health, Dallas Campus, Dallas, TX, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Lebron', 'Affiliation': 'Department of Public Health Sciences, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Catherina', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Nova Southeastern University, Davie, FL, USA.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Natale', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Messiah', 'Affiliation': 'University of Texas Health Science Center at Houston, School of Public Health, Dallas Campus, Dallas, TX, USA. Sarah.E.Messiah@uth.tmc.edu.'}]",World journal of pediatrics : WJP,['10.1007/s12519-021-00420-5']
533,33597589,Metabolomic differences between critically Ill women and men.,"Metabolism differs in women and men at homeostasis. Critically ill patients have profound dysregulation of homeostasis and metabolism. It is not clear if the metabolic response to critical illness differs in women compared to men. Such sex-specific differences in illness response would have consequences for personalized medicine. Our aim was to determine the sex-specific metabolomic response to early critical illness. We performed a post-hoc metabolomics study of the VITdAL-ICU trial where subjects received high dose vitamin D 3  or placebo. Using mixed-effects modeling, we studied sex-specific changes in metabolites over time adjusted for age, Simplified Acute Physiology Score II, admission diagnosis, day 0 25-hydroxyvitamin D level, and 25-hydroxyvitamin D response to intervention. In women, multiple members of the sphingomyelin and lysophospholipid metabolite classes had significantly positive Bonferroni corrected associations over time compared to men. Further, multiple representatives of the acylcarnitine, androgenic steroid, bile acid, nucleotide and amino acid metabolite classes had significantly negative Bonferroni corrected associations over time compared to men. Gaussian graphical model analyses revealed sex-specific functional modules. Our findings show that robust and coordinated sex-specific metabolite differences exist early in critical illness.",2021,"In women, multiple members of the sphingomyelin and lysophospholipid metabolite classes had significantly positive Bonferroni corrected associations over time compared to men.","['Critically ill patients', 'critically Ill women and men', 'women and men at homeostasis']",['vitamin D 3  or placebo'],"['25-hydroxyvitamin D level, and 25-hydroxyvitamin D response']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.160382,"In women, multiple members of the sphingomyelin and lysophospholipid metabolite classes had significantly positive Bonferroni corrected associations over time compared to men.","[{'ForeName': 'Sowmya', 'Initials': 'S', 'LastName': 'Chary', 'Affiliation': 'Biogen, Inc., 225 Binney St, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Amrein', 'Affiliation': 'Division of Endocrinology and Diabetology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Lasky-Su', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, 181 Longwood Avenue, Boston, USA.""}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Dobnig', 'Affiliation': 'Thyroid Endocrinology Osteoporosis Institute Dobnig, Jakob-Redtenbachergasse 10, 8010, Graz, Austria.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Christopher', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, 181 Longwood Avenue, Boston, USA. kbchristopher@bwh.harvard.edu.""}]",Scientific reports,['10.1038/s41598-021-83602-5']
534,33617161,An Isoelastic Monoblock Cup Retains More Acetabular and Femoral Bone Than a Modular Press-Fit Cup: A Prospective Randomized Controlled Trial.,"BACKGROUND


For cup revision after total hip arthroplasty, sufficiently good periacetabular bone stock is a prerequisite for fixation of the revision implant. Cementless cups can lead to a relevant reduction of peri-implant bone mineral density (BMD) through stress-shielding.
METHODS


Fifty patients were included in this prospective randomized controlled trial. Group 1 (RM group) received an isoelastic monoblock cup (RM Pressfit vitamys; Mathys). Group 2 (IT group) received a modular titanium cup (Allofit-S IT Alloclassic with a polyethylene liner; Zimmer). Periacetabular BMD was determined and subdivided into 4 regions of interest by dual x-ray absorptiometry at 1 week (baseline) and at 4 years postoperatively. Our primary outcome was reduction in periacetabular BMD.
RESULTS


Periacetabular BMD was reduced by an average of 15.1% in the RM group and 16.5% in the IT group at 4 years postoperatively. No significant difference was found between the 2 groups over the periacetabular structure as a whole. However, the decrease of BMD in the polar region was significantly different in the RM group (4.9% ± 10.0%) compared with the IT group (15.9% ± 14.9%, p = 0.005). Use of the isoelastic RM cup showed significantly less bone loss than the modular IT cup.
CONCLUSIONS


Relevant loss of BMD at 4 years after surgery was identified in the periacetabular region in both groups. No differences between the 2 cup systems were found when looking at the overall periacetabular region. As a secondary outcome, less postoperative periacetabular bone loss occurred in the polar region when an isoelastic cup was used. Longer follow-up is required to allow for conclusions to be drawn about the long-term course of the 2 cup systems.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2021,"Use of the isoelastic RM cup showed significantly less bone loss than the modular IT cup.
",['Fifty patients'],"['modular titanium cup (Allofit-S IT Alloclassic with a polyethylene liner', 'isoelastic RM cup', 'Modular Press-Fit Cup', 'isoelastic monoblock cup']","['reduction in periacetabular BMD', 'BMD', 'Periacetabular BMD', 'bone loss', 'postoperative periacetabular bone loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0441550', 'cui_str': 'Press-fit component fixation'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",50.0,0.0912243,"Use of the isoelastic RM cup showed significantly less bone loss than the modular IT cup.
","[{'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Brodt', 'Affiliation': 'Department of Orthopedics, Jena University Hospital, Campus Eisenberg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Jacob', 'Affiliation': ''}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Nowack', 'Affiliation': ''}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Zippelius', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Strube', 'Affiliation': ''}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Matziolis', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00787']
535,33619944,Long-term exercise effects after cardiac telerehabilitation in patients with coronary artery disease: 1-year follow-up results of the randomized study.,"BACKGROUND


Home-based cardiac telerehabilitation (HBCT) is a feasible and effective alternative to traditional center-based cardiac rehabilitation (CBCR). Currently, there are only limited studies focusing on a long-term effect of HBCT, which means it is essential to do more research in this study field.
AIM


This study aimed at investigating a 1-year effect of a randomized controlled study using Cardiac Rehabilitation through the Global Position System (CR-GPS) compared to outpatient cardiac rehabilitation. Study focused on cardiorespiratory fitness (CRF) and health-related quality of life (HRQL) in patients with coronary heart disease (CAD).
DESIGN


A long-term follow-up of a randomized study.
SETTING


Patients were enrolled, and the intervention was performed in an outpatient or home-based model. The results were obtained and evaluated in a hospital.
POPULATION


Patients who participated in the CR-GPS study were diagnosed with CAD with low to moderate cardiovascular risk.
METHODS


Patients enrolled in the study were eligible participants who had previously completed a 12-week HBCT program using a wrist heart rate (HR) monitor or attended a traditional CBCR. Primary outcome was the change in CRF expressed in peak oxygen uptake (pVO<inf>2</inf>), and the secondary outcomes were self-reported HRQL, objectively measured anthropometric characteristics, and mortality and hospitalization rates.
RESULTS


Forty-four patients (76%) completed the long-term follow-up. The average peak of pVO<inf>2</inf> was higher after 1-year follow-up in the telerehabilitation group (HBCT 25.5 mL/kg/min compared to the active control group CBCR 23.6 mL/kg/min P=0.047). No statistically significant difference between the two groups was found after long-term follow-up for the parameter HRQL. For both groups, there was a significant improvement in the range of perceptions of general health. There was no death case and no difference in hospitalization rate between the groups.
CONCLUSIONS


This study supports the HBCT model. It has been demonstrated that it induces satisfactory long-term effects in pVO<inf>2</inf>, exercise performance, and perceived general health in CAD patients with low to moderate cardiovascular risk.
CLINICAL REHABILITATION IMPACT


Cardiovascular telerehabilitation using wrist HR monitors is a feasible and effective rehabilitation method that can help patients eliminate barriers that prevent them from using CBCR programs. Especially in the current global situation with the COVID-19 pandemic, this topic is becoming increasingly important.",2021,The average peak of pVO2 was higher after 1-year follow-up in the telerehabilitation group (HBCT 25.5 ml / kg / min compared to the active control group CBCR 23.6 ml / kg / min p = 0.047).,"['patients with coronary heart disease (CAD', 'Patients enrolled in the study were eligible participants who had previously completed a 12-week HBCT program using a wrist heart rate (HR) monitor or attended a traditional CBCR', 'Patients who participated in the CR-GPS study were diagnosed with CAD with low to moderate cardiovascular risk', 'Patients were enrolled, and the intervention was performed in an outpatient or homebased model', 'patients with coronary artery disease', 'CAD patients with low to moderate cardiovascular risk', '44 patients (76%) completed the long-term follow-up']","['Home-based cardiac telerehabilitation (HBCT', 'HBCT', 'cardiac telerehabilitation', 'Cardiac Rehabilitation through the Global Position System (CR-GPS']","['cardiorespiratory fitness (CRF) and health-related quality of life (HRQL', 'hospitalization rate', 'average peak of pVO2', 'change in CRF expressed in peak oxygen uptake (pVO2), and the secondary outcomes were self-reported HRQL, objectively measured anthropometric characteristics, and mortality and hospitalization rates', 'range of perceptions of general health']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]",,0.0618431,The average peak of pVO2 was higher after 1-year follow-up in the telerehabilitation group (HBCT 25.5 ml / kg / min compared to the active control group CBCR 23.6 ml / kg / min p = 0.047).,"[{'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Batalik', 'Affiliation': 'Department of Rehabilitation, University Hospital of Brno, Brno, Czech Republic - batalik.ladislav@fnbrno.cz.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Dosbaba', 'Affiliation': 'Department of Rehabilitation, University Hospital of Brno, Brno, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hartman', 'Affiliation': 'Department of Rehabilitation, University Hospital of Brno, Brno, Czech Republic.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Konecny', 'Affiliation': 'Department of Rehabilitation, University Hospital of Brno, Brno, Czech Republic.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Batalikova', 'Affiliation': 'Department of Rehabilitation, University Hospital of Brno, Brno, Czech Republic.'}, {'ForeName': 'Jindrich', 'Initials': 'J', 'LastName': 'Spinar', 'Affiliation': ""First Department of Internal Medicine and Cardioangiology, Institutions shared with St. Anne's Faculty Hospital, Faculty of Medicine, Masaryk University, Brno, Czech Republic.""}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.21.06653-3']
536,33819571,Fourteen-day survival among older adults with severe infection with severe acute respiratory syndrome coronavirus 2 treated with corticosteroid: a cohort study.,"OBJECTIVE


To assess the effectiveness of corticosteroids among older adults with coronavirus disease 2019 (COVID-19) pneumonia requiring oxygen.
METHODS


We used routine care data from 36 hospitals in France and Luxembourg to assess the effectiveness of corticosteroids with at least 0.4 mg/kg/day equivalent prednisone (treatment group) versus standard of care (control group). Participants were adults aged 80 years or older with PCR-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or CT scan images typical of COVID-19 pneumonia, requiring oxygen ≥3 L/min, and with an inflammatory syndrome (C-reactive protein ≥40 mg/L). The primary outcome was overall survival at day 14. In our main analysis, characteristics of patients at baseline (i.e. time when patients met all inclusion criteria) were balanced by using propensity-score inverse probability of treatment weighting.
RESULTS


Among the 267 patients included in the analysis, 98 were assigned to the treatment group. Their median age was 86 years (interquartile range 83-90 years) and 95% had a SARS-CoV-2 PCR-confirmed diagnosis. In total, 43/98 (43.9%) patients in the treatment group and 84/166 (50.6%) in the control group died before day 14 (weighted hazard ratio 0.67, 95% CI 0.46-0.99). The treatment and control groups did not differ significantly for the proportion of patients discharged to home/rehabilitation at day 14 (weighted relative risk 1.12, 95% CI 0.68-1.82). Twenty-two (16.7%) patients receiving corticosteroids developed adverse events, but only 11 (6.4%) from the control group.
CONCLUSIONS


Corticosteroids were associated with a significant increase in the overall survival at day 14 of patients aged 80 years and older hospitalized for severe COVID-19.",2021,"The treatment and control groups did not differ significantly for the proportion of patients discharged to home/rehabilitation at day 14 (wRR 1.12, 95% CI 0.68 to 1.82).","['older adults with COVID-19 pneumonia requiring oxygen', '267 patients included in the analysis, 98 were assigned to the treatment group', 'older adults with severe SARS-Cov2 infection treated with', '≥ 80\xa0years old with PCR-confirmed SARS-CoV-2 infection or CT-scan images typical of COVID-19 pneumonia, requiring oxygen ≥ 3 L/min, and with an inflammatory syndrome (C-reactive protein ≥ 40 mg/L', 'Their median age was 86\xa0years (interquartile range 83 to 90), and 95% had a SARS-CoV-2 PCR-confirmed diagnosis', '36 hospitals in France and Luxembourg']","['prednisone', 'standard of care (control group', 'corticosteroid', 'corticosteroids']","['overall survival', 'adverse events', 'proportion of patients discharged to home/rehabilitation', '14-Day survival']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",267.0,0.264782,"The treatment and control groups did not differ significantly for the proportion of patients discharged to home/rehabilitation at day 14 (wRR 1.12, 95% CI 0.68 to 1.82).","[{'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gallay', 'Affiliation': 'Département de Médecine Interne et Immunologie Clinique, Centre Hospitalo-Universitaire Edouard Herriot, Hospices Civils de Lyon, Université Claude Bernard Lyon, Lyon, France.'}, {'ForeName': 'Viet-Thi', 'Initials': 'VT', 'LastName': 'Tran', 'Affiliation': ""Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris / Université de Paris, Centre de Recherche Epidémiologie et Statistiques (CRESS UMR 1153), Paris, France.""}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Perrodeau', 'Affiliation': ""Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris / Université de Paris, Centre de Recherche Epidémiologie et Statistiques (CRESS UMR 1153), Paris, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Vignier', 'Affiliation': 'Groupe Hospitalier Sud Ile-de-France, Inserm CIC 1424 & Sorbonne Université, IPLESP, Inserm UMR 1136, Paris, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Mahevas', 'Affiliation': 'Service de Médecine Interne, Hôpital Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bisio', 'Affiliation': 'Département de Médecine, Centre Hospitalier de Vierzon, Vierzon, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Forestier', 'Affiliation': 'Service de Maladies Infectieuses, Centre Hospitalier Métropole Savoie, Chambéry, France.'}, {'ForeName': 'Francois-Xavier', 'Initials': 'FX', 'LastName': 'Lescure', 'Affiliation': 'Service de Maladies Infectieuses et Tropicales, Hôpital Bichat, Assistance Publique Hôpitaux de Paris / Université de Paris, IAME, Inserm UMR 1137, 75018, Paris, France. Electronic address: xavier.lescure@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2021.03.021']
537,33819508,Differential induction of allergen-specific IgA responses following timothy grass subcutaneous and sublingual immunotherapy.,"INTRODUCTION


There is no detailed comparison of allergen-specific immunoglobulin responses following sublingual immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT).
OBJECTIVE


We sought to compare nasal and systemic timothy grass pollen (TGP)-specific antibody responses during 2 years of SCIT and SLIT and 1 year after treatment discontinuation in a double-blind, double-dummy, placebo-controlled trial.
METHODS


Nasal fluid and serum were obtained yearly (per-protocol population, n = 84). TGP-specific IgA 1 , IgA 2 , IgG 4 , IgG, and IgE were measured in nasal fluids by ELISA. TGP-specific IgA 1 , IgA 2 , and Phleum pratense (Phl p)1, 2, 4, 5b, 6, 7, 11, and 12 IgE and IgG 4  were measured in sera by ELISA and ImmunoCAP, respectively.
RESULTS


At years 2 and 3, TGP-IgA 1/2  levels in nasal fluid were elevated in SLIT compared with SCIT (4.2- and 3.0-fold for IgA 1 , 2.0- and 1.8-fold for IgA 2 , respectively; all P < .01). TGP-IgA 1  level in serum was elevated in SLIT compared with SCIT at years 1, 2, and 3 (4.6-, 5.1-, and 4.7-fold, respectively; all P < .001). Serum TGP-IgG level was higher in SCIT compared with SLIT (2.8-fold) at year 2. Serum TGP-IgG 4  level was higher in SCIT compared with SLIT at years 1, 2, and 3 (10.4-, 27.4-, and 5.1-fold, respectively; all P < .01). Serum IgG 4  levels to Phl p1, 2, 5b, and 6 were increased at years 1, 2, and 3 in SCIT and SLIT compared with placebo (Phl p1: 11.8- and 3.9-fold; Phl p2: 31.6- and 4.4-fold; Phl p5b: 135.5- and 5.3-fold; Phl p6: 145.4- and 14.7-fold, respectively, all at year 2 when levels peaked; P < .05). IgE to TGP in nasal fluid increased in the SLIT group at year 2 but not at year 3 compared with SCIT (2.8-fold; P = .04) and placebo (3.1-fold; P = .02). IgA to TGP and IgE and IgG 4  to TGP components stratified participants according to treatment group and clinical response.
CONCLUSIONS


The observed induction of IgA 1/2  in SLIT and IgG 4  in SCIT suggest key differences in the mechanisms of action.",2021,IgE to TGP in nasal fluid increased in the SLIT group at year 2 but not year 3 compared to SCIT (2.8-fold; P=.04) and placebo (3.1-fold; P=.02).,[],"['sublingual (SLIT) and subcutaneous (SCIT) immunotherapy', 'placebo', 'Timothy Grass Subcutaneous and Sublingual Immunotherapy', 'systemic Timothy grass pollen']","['TGP)-specific antibody responses', 'TGP-IgA 1/2  in nasal fluid', 'IgE to TGP in nasal fluid', 'TGP-IgA 1  in serum', 'TGP-specific IgA 1 , IgA 2 , IgG 4 , IgG and IgE', 'Serum TGP-IgG', 'Serum TGP-IgG 4']",[],"[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0413381', 'cui_str': 'Subcutaneous immunotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0446282', 'cui_str': 'Phleum'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0440330', 'cui_str': 'Timothy grass pollen'}]","[{'cui': 'C0440330', 'cui_str': 'Timothy grass pollen'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C1444694', 'cui_str': 'Nasal fluid'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",4.0,0.0878138,IgE to TGP in nasal fluid increased in the SLIT group at year 2 but not year 3 compared to SCIT (2.8-fold; P=.04) and placebo (3.1-fold; P=.02).,"[{'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Shamji', 'Affiliation': 'National Heart and Lung Institute, Allergy and Clinical Immunology, Imperial College NIHR Biomedical Research Centre, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom. Electronic address: m.shamji@imperial.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Larson', 'Affiliation': 'Immune Tolerance Network, Bethesda, Md.'}, {'ForeName': 'Aarif', 'Initials': 'A', 'LastName': 'Eifan', 'Affiliation': 'National Heart and Lung Institute, Allergy and Clinical Immunology, Imperial College NIHR Biomedical Research Centre, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Guy W', 'Initials': 'GW', 'LastName': 'Scadding', 'Affiliation': 'National Heart and Lung Institute, Allergy and Clinical Immunology, Imperial College NIHR Biomedical Research Centre, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Tielin', 'Initials': 'T', 'LastName': 'Qin', 'Affiliation': 'Immune Tolerance Network, Bethesda, Md.'}, {'ForeName': 'Kaitie', 'Initials': 'K', 'LastName': 'Lawson', 'Affiliation': 'Rho Federal Systems Division, Durham, NC.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Sever', 'Affiliation': 'Rho Federal Systems Division, Durham, NC.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Macfarlane', 'Affiliation': 'National Heart and Lung Institute, Allergy and Clinical Immunology, Imperial College NIHR Biomedical Research Centre, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Janice A', 'Initials': 'JA', 'LastName': 'Layhadi', 'Affiliation': 'National Heart and Lung Institute, Allergy and Clinical Immunology, Imperial College NIHR Biomedical Research Centre, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Würtzen', 'Affiliation': 'Translational Research, ALK, Hørsholm, Denmark.'}, {'ForeName': 'Rebecca V', 'Initials': 'RV', 'LastName': 'Parkin', 'Affiliation': 'National Heart and Lung Institute, Allergy and Clinical Immunology, Imperial College NIHR Biomedical Research Centre, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Srinath', 'Initials': 'S', 'LastName': 'Sanda', 'Affiliation': 'Immune Tolerance Network, San Francisco, Calif.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Harris', 'Affiliation': 'Immune Tolerance Network, Bethesda, Md.'}, {'ForeName': 'Gerald T', 'Initials': 'GT', 'LastName': 'Nepom', 'Affiliation': 'Immune Tolerance Network, Bethesda, Md; Benaroya Research Institute at Virginia Mason, Seattle, Wash.'}, {'ForeName': 'Alkis', 'Initials': 'A', 'LastName': 'Togias', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Md.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Durham', 'Affiliation': 'National Heart and Lung Institute, Allergy and Clinical Immunology, Imperial College NIHR Biomedical Research Centre, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom; Immune Tolerance Network, Bethesda, Md.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.03.030']
538,33615388,Biventricular function in exercise during autonomic (thoracic epidural) block.,"BACKGROUND


Blockade of cardiac sympathetic fibers by thoracic epidural anesthesia (TEA) was previously shown to reduce right and left ventricular systolic function and effective pulmonary arterial elastance. At conditions of constant paced heart rate, cardiac output and systemic hemodynamics were unchanged. In this study, we further investigated the effect of cardiac sympathicolysis during physical stress and increased oxygen demand.
METHODS


In a cross-over design, 12 patients scheduled to undergo thoracic surgery performed dynamic ergometric exercise tests with and without TEA. Hemodynamics were monitored and biventricular function was measured by transthoracic two-dimensional and M-mode echocardiography, pulsed wave Doppler and tissue Doppler imaging.
RESULTS


TEA attenuated systolic RV function (TV S': - 21%, P < 0.001) and LV function (MV S': - 14%, P = 0.025), but biventricular diastolic function was not affected. HR (- 11%, P < 0.001), SVI (- 15%, P = 0.006), CI (- 21%, P < 0.001) and MAP (- 12%, P < 0.001) were decreased during TEA, but SVR was not affected. Exercise resulted in significant augmentation of systolic and diastolic biventricular function. During exercise HR, SVI, CI and MAP increased (respectively, + 86%, + 19%, + 124% and + 17%, all P < 0.001), whereas SVR decreased (- 49%, P < 0.001). No significant interactions between exercise and TEA were found, except for RPP (P = 0.024) and MV E DT (P = 0.035).
CONCLUSION


Cardiac sympathetic blockade by TEA reduced LV and RV systolic function but did not significantly blunt exercise-induced increases in LV and RV function. These data indicate that additional mechanisms besides those controlled by the cardiac sympathetic nervous system are involved in the regulation of cardiac function during dynamic exercise. Trial registration Clinical trial registration: Nederlands Trial Register, NTR 4880 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4880 .",2021,"RESULTS


TEA attenuated systolic RV function (TV S': - 21%, P < 0.001) and LV function (MV S': - 14%, P = 0.025), but biventricular diastolic function was not affected.",['12 patients scheduled to undergo'],"['thoracic epidural anesthesia (TEA', 'thoracic surgery performed dynamic ergometric exercise tests with and without TEA', 'TEA']","['MAP', 'constant paced heart rate, cardiac output and systemic hemodynamics', 'right and left ventricular systolic function and effective pulmonary arterial elastance', 'systolic RV function', 'biventricular diastolic function', 'LV function', 'SVR', 'LV and RV systolic function', 'SVI', 'LV and RV function', 'RPP', 'biventricular function', 'systolic and diastolic biventricular function', 'exercise HR, SVI, CI and MAP', 'MV E DT']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",12.0,0.139692,"RESULTS


TEA attenuated systolic RV function (TV S': - 21%, P < 0.001) and LV function (MV S': - 14%, P = 0.025), but biventricular diastolic function was not affected.","[{'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Wink', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. j.wink@lumc.nl.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Steendijk', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Roula', 'Initials': 'R', 'LastName': 'Tsonaka', 'Affiliation': 'Department of Biomedical Data Sciences, Medical Statistics Section, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Rob B P', 'Initials': 'RBP', 'LastName': 'de Wilde', 'Affiliation': 'Department of Intensive Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Friedericy', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Department of Cardio-Thoracic Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Bernadette Th', 'Initials': 'BT', 'LastName': 'Veering', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Leon P H J', 'Initials': 'LPHJ', 'LastName': 'Aarts', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Patrick F', 'Initials': 'PF', 'LastName': 'Wouters', 'Affiliation': 'Department of Anesthesia, University Hospitals Ghent, Ghent, Belgium.'}]",European journal of applied physiology,['10.1007/s00421-021-04631-6']
539,33620545,Effects of acute dietary nitrate supplementation on cold-induced vasodilation in healthy males.,"PURPOSE


Cold-induced vasodilation (CIVD) is a paradoxical rise in blood flow to the digits that occur during prolonged cold exposure. CIVD is thought to occur through active vasodilation and/or sympathetic withdrawal, where nitric oxide (NO) may play a key role in mediating these mechanisms. Beetroot juice (BRJ) is high in dietary nitrate (NO 3 - ) which undergoes sequential reduction to nitrite (NO 2 - ) and subsequently NO. Using a double-blind, randomized, crossover design, we examined the effect of acute BRJ supplementation on the CIVD response in 10 healthy males.
METHODS


Participants had a resting blood pressure measurement taken prior to ingesting 140 mL of nitrate-rich BRJ (13 mmol NO 3 - ) or a NO 3 - -free placebo (PLA). After 2 h, participants immersed their hand in neutral water (~ 35 °C) for 10 min of baseline before cold water immersion (~ 8 °C) for 30 min. Laser-Doppler fluxmetry and skin temperature were measured continuously on the digits.
RESULTS


Compared to PLA (100 ± 3 mmHg), acute BRJ supplementation significantly reduced mean arterial pressure at -30 min (96 ± 2 mmHg; p = 0.007) and 0 min (94 ± 2 mmHg; p = 0.008). Acute BRJ supplementation had no effect on Laser-Doppler fluxmetry during CIVD (expressed as cutaneous vascular conductance) measured as area under the curve (BRJ: 843 ± 148 PU mmHg -1  s; PLA: 1086 ± 333 PU mmHg -1  s), amplitude (BRJ: 0.60 ± 0.12 PU mmHg -1 ; PLA: 0.69 ± 0.14 PU mmHg -1 ), and duration (BRJ: 895 ± 60 s; PLA: 894 ± 46 s).
CONCLUSION


Acute BRJ supplementation does not augment the CIVD response in healthy males.",2021,"Acute BRJ supplementation had no effect on Laser-Doppler fluxmetry during CIVD (expressed as cutaneous vascular conductance) measured as area under the curve (BRJ: 843 ± 148 PU mmHg -1  s; PLA: 1086 ± 333 PU mmHg -1  s), amplitude (BRJ: 0.60 ± 0.12 PU mmHg -1 ; PLA: 0.69 ± 0.14 PU mmHg -1 ), and duration (BRJ: 895 ± ","['healthy males', 'Participants had a resting blood pressure measurement taken prior to ingesting 140\xa0mL of nitrate-rich BRJ (13\xa0mmol', '10 healthy males']","['Acute BRJ supplementation', 'Cold-induced vasodilation (CIVD', 'acute BRJ supplementation', 'acute dietary nitrate supplementation', 'Beetroot juice (BRJ']","['mean arterial pressure', 'CIVD response', 'Laser-Doppler fluxmetry', 'cold-induced vasodilation', 'Laser-Doppler fluxmetry and skin temperature']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0439190', 'cui_str': 'mmol'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0430489', 'cui_str': 'Laser doppler'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}]",10.0,0.0582363,"Acute BRJ supplementation had no effect on Laser-Doppler fluxmetry during CIVD (expressed as cutaneous vascular conductance) measured as area under the curve (BRJ: 843 ± 148 PU mmHg -1  s; PLA: 1086 ± 333 PU mmHg -1  s), amplitude (BRJ: 0.60 ± 0.12 PU mmHg -1 ; PLA: 0.69 ± 0.14 PU mmHg -1 ), and duration (BRJ: 895 ± ","[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Wickham', 'Affiliation': 'Environmental Ergonomics Lab, Brock University, St. Catharines, ON, Canada.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Steele', 'Affiliation': 'Environmental Ergonomics Lab, Brock University, St. Catharines, ON, Canada.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Cheung', 'Affiliation': 'Environmental Ergonomics Lab, Brock University, St. Catharines, ON, Canada. stephen.cheung@brocku.ca.'}]",European journal of applied physiology,['10.1007/s00421-021-04621-8']
540,33629961,Evaluating the Effectiveness of a Web-Based Program (POP4Teens) to Prevent Prescription Opioid Misuse Among Adolescents: Randomized Controlled Trial.,"BACKGROUND


Prescription opioid (PO) use is common among adolescents in the United States. Despite recent declines from unprecedented peaks in adolescent PO use (eg, in 2012-2013), there is seemingly paradoxical evidence that PO-related consequences (eg, opioid use disorder and overdoses) are increasing. These trends and their possible consequences emphasize the importance of prevention efforts targeting PO misuse. To our knowledge, we have developed the first interactive web-based program (POP4Teens [P4T]) focused specifically on the prevention of PO misuse among adolescents.
OBJECTIVE


This study aimed to evaluate the effectiveness of P4T, a web-based program designed to prevent adolescent PO misuse, in comparison with JustThinkTwice (JTT), an active control website, on PO-related attitudes, knowledge, risk perception, and intentions to use.
METHODS


We conducted a web-based randomized controlled trial in 2018. A total of 406 adolescents (aged 12-17 years) were randomly assigned to either P4T or JTT. The outcome variables were attitudes, knowledge, and risk perceptions associated with PO misuse, intentions to use POs, and program feedback. Data were collected at baseline and at 1, 3, and 6 months.
RESULTS


Both programs resulted in significant and sustained improvements in intention to use POs, increased perceived risk, impacted expectancies consistent with prevention, and improved PO refusal skills. P4T produced significantly greater increases in PO-related knowledge than JTT did, and it was reportedly easier to use and more liked. Baseline scores for youth reporting past-year medical use of POs, friends who engage in nonmedical use of POs, and/or poor mental health underscored their at-risk status compared with youth from the other groups.
CONCLUSIONS


P4T positively impacted all study variables that are known to prevent PO misuse among teens. Moreover, its web-based nature simplifies the dissemination and implementation of this novel tool designed to help meet the challenges of the evolving national opioid crisis.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02737696; https://clinicaltrials.gov/ct2/show/NCT02737696.",2021,"Both programs resulted in significant and sustained improvements in intention to use POs, increased perceived risk, impacted expectancies consistent with prevention, and improved PO refusal skills.","['Adolescents', 'adolescents', '406 adolescents (aged 12-17 years', 'adolescents in the United States']","['P4T or JTT', 'P4T', 'Web-Based Program (POP4Teens) to Prevent Prescription Opioid Misuse', 'JustThinkTwice (JTT']","['intention to use POs, increased perceived risk, impacted expectancies consistent with prevention, and improved PO refusal skills', 'attitudes, knowledge, and risk perceptions associated with PO misuse, intentions to use POs, and program feedback']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",406.0,0.0653884,"Both programs resulted in significant and sustained improvements in intention to use POs, increased perceived risk, impacted expectancies consistent with prevention, and improved PO refusal skills.","[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Marsch', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth College, Lebanon, NH, United States.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Moore', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth College, Lebanon, NH, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grabinski', 'Affiliation': 'HealthSim Inc, Hanover, NH, United States.'}, {'ForeName': 'Sarah Y', 'Initials': 'SY', 'LastName': 'Bessen', 'Affiliation': 'Geisel School of Medicine at Dartmouth College, Hanover, NH, United States.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Borodovsky', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth College, Lebanon, NH, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Scherer', 'Affiliation': 'Department of Biomedical Data Science, Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth College, Lebanon, NH, United States.'}]",JMIR public health and surveillance,['10.2196/18487']
541,33628967,A theory of planned behavior-enhanced intervention to promote health literacy and self-care behaviors of type 2 diabetic patients.,"Background


Improved health literacy and awareness could help type 2 diabetic patients to control the disease complications.
Objective


The current study aimed to evaluate the impact of theory-based educational intervention on health literacy and self-care behaviors of type 2 diabetic patients in Tonekabon city.
Methods


This randomized controlled trial study was conducted at health care centers in Tonekabon city, Iran, from April 5, 2017, to October 22, 2018. Using multistage random sampling, 166 patients with type 2 diabetes divided into two groups: theory-based intervention (n = 83) and custom education (n = 83). The data collection tools consisted of demographic information, Theory of Planned Behavior (TPB) measures, health literacy for Iranian adults (HELIA) and summary of diabetes self-care activities (SDSCA). The five 45-minute group training sessions based on the baseline assessment and model constructs along with the targeted pamphlet and m-health strategy were designed for the experimental group. Data were analyzed using chi-square, independent and paired t-test and Analysis of covariance (ANCOVA).
Results


After controlling for pre-test effect, there was a significant difference between the two groups in terms of mean scores of attitudes, subjective norms, perceived behavior control and intention in post-test (P < 0.001). Also, after controlling for the pre-test effect, the results showed a significant difference in the self-care domain in the post-test (P < 0.001). Finally, after controlling for the pre-test variable effect, covariance analysis reflects significant difference in total health literacy score and its dimension at posttest (P < 0.001).
Conclusions


Applying TPB based education is suggested to maintain and improve self-care behaviors and health literacy in type 2 diabetic patients and other chronic diseases.",2020,"After controlling for pre-test effect, there was a significant difference between the two groups in terms of mean scores of attitudes, subjective norms, perceived behavior control and intention in post-test (P < 0.001).","['type 2 diabetic patients and other chronic diseases', 'health care centers in Tonekabon city, Iran, from April 5, 2017, to October 22, 2018', '166 patients with type 2 diabetes divided into two groups', 'type 2 diabetic patients in Tonekabon city', 'type 2 diabetic patients']","['planned behavior-enhanced intervention', 'theory-based intervention (n = 83) and custom education', 'theory-based educational intervention']","['health literacy and self-care behaviors', 'self-care domain', 'health literacy and awareness', 'Planned Behavior (TPB) measures, health literacy for Iranian adults (HELIA) and summary of diabetes self-care activities (SDSCA', 'self-care behaviors and health literacy', 'mean scores of attitudes, subjective norms, perceived behavior control and intention in post-test', 'total health literacy score']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376287', 'cui_str': 'Behavioral Manipulation'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",166.0,0.0267767,"After controlling for pre-test effect, there was a significant difference between the two groups in terms of mean scores of attitudes, subjective norms, perceived behavior control and intention in post-test (P < 0.001).","[{'ForeName': 'Isa Mohammadi', 'Initials': 'IM', 'LastName': 'Zeidi', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Morshedi', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Alizadeh Otaghvar', 'Affiliation': 'Trauma and Injury Research Center, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of preventive medicine and hygiene,['10.15167/2421-4248/jpmh2020.61.4.1504']
542,33633036,Brief Report: Switching to DOR/3TC/TDF Maintains HIV-1 Virologic Suppression Through Week 144 in the DRIVE-SHIFT Trial.,"BACKGROUND


In the primary analysis of the DRIVE-SHIFT trial, switching to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) maintained suppression of HIV-1 through week 48. Here, we present long-term efficacy and safety outcomes through week 144 of the DRIVE-SHIFT trial.
METHODS


This phase 3, randomized, open-label trial evaluated switching from a stable antiretroviral regimen to once-daily DOR/3TC/TDF in adults with HIV-1 suppressed for ≥6 months and no previous virologic failure. Participants switched at day 1 [immediate switch group (ISG); n = 447] or week 24 [delayed switch group (DSG); n = 209]. Nine ISG participants who completed week 48 but did not enter extension-1 were excluded from week 144 efficacy analyses.
RESULTS


At week 144, HIV-1 RNA <50 copies/mL was maintained in 80.1% of the ISG (351/438) and 83.7% of the DSG (175/209), while 2.7% (12/438) and 4.8% (10/209), respectively, had HIV-1 RNA ≥50 copies/mL (Food and Drug Administration Snapshot approach). Protocol-defined virologic failure after switch occurred in 2.1% of ISG (9/438) and 3.3% of DSG (7/209); no viral resistance to doravirine was detected in 4 participants with samples available. Reductions in fasting lipids were observed at 24 weeks after switch and maintained through week 144. The mean weight change from switch to week 144 was +1.4 kg for ISG and +1.2 kg for DSG. The most common adverse events were nasopharyngitis (16.2%), headache (12.3%), and diarrhea (9.1%). Overall, 4.1% discontinued because of adverse events, and no deaths occurred.
CONCLUSIONS


These results confirm that switching to once-daily DOR/3TC/TDF is a generally well-tolerated option for maintaining viral suppression in adults considering a change in therapy.
REGISTRATION


ClinicalTrials.gov NCT02397096.",2021,"At Week 144, HIV-1 RNA <50 copies/mL was maintained in 80.1% of the ISG (351/438) and 83.7% of the DSG (175/209), while 2.7% (12/438) and 4.8% (10/209), respectively, had HIV-1 RNA ≥50 copies/mL (FDA Snapshot).",['adults with HIV-1 suppressed for ≥6 months and no previous virologic failure'],"['Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF', 'doravirine/lamivudine/ tenofovir disoproxil fumarate (DOR/3TC/TDF']","['virologic failure', 'Virologic Suppression', 'Mean weight change', 'viral resistance to doravirine', 'fasting lipids', 'diarrhea', 'headache']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}]","[{'cui': 'C4723313', 'cui_str': 'lamivudine, tenofovir disoproxil and doravirine'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}]","[{'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0520989', 'cui_str': 'Viral resistance'}, {'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",9.0,0.152751,"At Week 144, HIV-1 RNA <50 copies/mL was maintained in 80.1% of the ISG (351/438) and 83.7% of the DSG (175/209), while 2.7% (12/438) and 4.8% (10/209), respectively, had HIV-1 RNA ≥50 copies/mL (FDA Snapshot).","[{'ForeName': 'Princy', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Division of Infectious Diseases and Travel Medicine, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Department of HIV Medicine, Royal Free Hospital, London, United Kingdom.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Saint-Louis and Lariboisière Hospitals, APHP, University of Paris, INSERM U944, Paris, France.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Rizzardini', 'Affiliation': 'Department of Infectious Diseases, ASST Fatebenefratelli Sacco Hospital, Milan, Italy.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundación Huésped and Buenos Aires University, Buenos Aires, Argentina.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bickel', 'Affiliation': 'Infektiologikum, Centre for Infectious Diseases, Frankfurt, Germany; and.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Zhi Jin', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Morais', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sklar', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Greaves', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002642']
543,33638690,Patterns of responses and time-course of changes in muscle size and strength during low-load blood flow restriction resistance training in women.,"PURPOSE


The purpose of this investigation was to examine the individual and composite patterns of responses and time-course of changes in muscle size, strength, and edema throughout a 4 week low-load blood flow restriction (LLBFR) resistance training intervention.
METHODS


Twenty recreationally active women (mean ± SD; 23 ± 3 years) participated in this investigation and were randomly assigned to 4 weeks (3/week) of LLBFR (n = 10) or control (n = 10) group. Resistance training consisted of 75 reciprocal isokinetic forearm flexion-extension muscle actions performed at 30% of peak torque. Strength and ultrasound-based assessments were determined at each training session.
RESULTS


There were quadratic increases for composite muscle thickness (R 2  = 0.998), concentric peak torque (R 2  = 0.962), and maximal voluntary isometric contraction (MVIC) torque (R 2  = 0.980) data for the LLBFR group. For muscle thickness, seven of ten subjects exceeded the minimal difference (MD) of 0.16 cm during the very early phase (laboratory visits 1-7) of the intervention compared to three of ten subjects that exceeded MD for either concentric peak torque (3.7 Nm) or MVIC (2.2 Nm) during this same time period. There was a linear increase for composite echo intensity (r 2  = 0.563) as a result of LLBFR resistance training, but eight of ten subjects never exceeded the MD of 14.2 Au.
CONCLUSIONS


These findings suggested that the increases in muscle thickness for the LLBFR group were not associated with edema and changes in echo intensity should be examined on a subject-by-subject basis. Furthermore, LLBFR forearm flexion-extension resistance training elicited real increases in muscle size during the very early phase of training that occurred prior to real increases in muscle strength.",2021,"There were quadratic increases for composite muscle thickness (R 2  = 0.998), concentric peak torque (R 2  = 0.962), and maximal voluntary isometric contraction (MVIC) torque (R 2  = 0.980) data for the LLBFR group.","['women', 'Twenty recreationally active women (mean\u2009±\u2009SD; 23\u2009±\u20093 years']","['LLBFR', 'low-load blood flow restriction resistance training', 'Resistance training consisted of 75 reciprocal isokinetic forearm flexion-extension muscle actions']","['composite echo intensity', 'muscle strength', 'maximal voluntary isometric contraction (MVIC) torque', 'muscle size, strength, and edema', 'muscle thickness', 'concentric peak torque', 'composite muscle thickness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",75.0,0.0106756,"There were quadratic increases for composite muscle thickness (R 2  = 0.998), concentric peak torque (R 2  = 0.962), and maximal voluntary isometric contraction (MVIC) torque (R 2  = 0.980) data for the LLBFR group.","[{'ForeName': 'Ethan C', 'Initials': 'EC', 'LastName': 'Hill', 'Affiliation': 'Division of Kinesiology, School of Kinesiology and Physical Therapy, University of Central Florida, 12494 University Boulevard, Orlando, FL, 32816, USA. ethan.hill@ucf.edu.'}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Housh', 'Affiliation': 'Human Performance Laboratory, Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE, 68505, USA.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Keller', 'Affiliation': 'Department of Health, Kinesiology and Sport, College of Education and Professional Studies, University of South Alabama, Mobile, AL, 36688, USA.'}, {'ForeName': 'Cory M', 'Initials': 'CM', 'LastName': 'Smith', 'Affiliation': 'Department of Kinesiology, College of Health Sciences, University of Texas at El Paso, El Paso, TX, 79968, USA.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Anders', 'Affiliation': 'Human Performance Laboratory, Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE, 68505, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Schmidt', 'Affiliation': 'Human Performance Laboratory, Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE, 68505, USA.'}, {'ForeName': 'Glen O', 'Initials': 'GO', 'LastName': 'Johnson', 'Affiliation': 'Human Performance Laboratory, Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE, 68505, USA.'}, {'ForeName': 'Joel T', 'Initials': 'JT', 'LastName': 'Cramer', 'Affiliation': 'Department of Kinesiology, College of Health Sciences, University of Texas at El Paso, El Paso, TX, 79968, USA.'}]",European journal of applied physiology,['10.1007/s00421-021-04627-2']
544,33639664,Psycho-Education on Knowledge of Oral Hygiene and Psychological Distress to the Parents with Leukemia Children.,"OBJECTIVE


To analyze the effect of psycho-educational intervention on knowledge of oral hygiene and psychological distress to the parents of children suffering from leukemia.
METHODS


Design of this study was a quasi-experimental pre-posttest control group design. The sample were 70 mothers who had children with leukemia (intervention group = 35 mothers; control group = 35 mothers). The independent variable was psycho-educational, while the dependent variables were oral hygiene knowledge and psychological distress. The instruments used were the knowledge questionnaire and the Depression-Anxiety-Stress Scale (DASS-21). Data were analyzed using the Wilcoxon signed rank test and the Mann Whitney U-test with the significance α =0.05.
RESULTS


The knowledge most widely known by parents was about how to perform of oral care (37.3%). All parameters of knowledge about oral hygiene have increased after being given a psycho-educational intervention. Psycho-educational interventions had an effect on reducing psychological distress; depression (p=0.000), anxiety (p=0.001) and stress (p=0.000).
CONCLUSION


Most parents whose children suffer from cancer experience psychological distress in the form of depression, anxiety and stress with a range of symptoms ranging from mild to moderate. Psycho-educational interventions can increase knowledge about oral hygiene and decrease psychological distress in parents. <br />.",2021,"Psycho-educational interventions had an effect on reducing psychological distress; depression (p=0.000), anxiety (p=0.001) and stress (p=0.000).
","['Parents with Leukemia Children', 'parents', 'parents of children suffering from leukemia', '70 mothers who had children with leukemia (intervention group = 35 mothers; control group = 35 mothers']","['Psycho-Education', 'Psycho-educational interventions', 'psycho-educational intervention']","['anxiety', 'knowledge of oral hygiene and psychological distress', 'psychological distress; depression', 'Knowledge of Oral Hygiene and Psychological Distress', 'knowledge questionnaire and the Depression-Anxiety-Stress Scale (DASS-21', 'psychological distress', 'oral hygiene knowledge and psychological distress']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}]",70.0,0.0234566,"Psycho-educational interventions had an effect on reducing psychological distress; depression (p=0.000), anxiety (p=0.001) and stress (p=0.000).
","[{'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Krisnana', 'Affiliation': 'Faculty of Nursing Universitas Airlangga, Surabaya Indonesia.'}, {'ForeName': 'Iqlima Dwi', 'Initials': 'ID', 'LastName': 'Kurnia', 'Affiliation': 'Faculty of Nursing Universitas Airlangga, Surabaya Indonesia.'}, {'ForeName': 'Pujiati', 'Initials': 'P', 'LastName': 'Pujiati', 'Affiliation': 'Soetomo General Hospital, Surabaya, Indonesia.'}, {'ForeName': 'I Dewa Gede', 'Initials': 'IDG', 'LastName': 'Ugrasena', 'Affiliation': 'Faculty of Medicine Universitas Airlangga,Surabaya, Indonesia.'}, {'ForeName': 'Yuni Sufyanti', 'Initials': 'YS', 'LastName': 'Arief', 'Affiliation': 'Faculty of Nursing Universitas Airlangga, Surabaya Indonesia.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2021.22.2.485']
545,33639662,Human Papillomavirus (HPV) Health Savings as an Alternative Solution: HPV Vaccination Behavior in Adolescents.,"OBJECTIVE


This study aimed to measure the effects of reproductive health savings (tabungan kesehatan reproduksi, Takespro) on human papillomavirus (HPV) vaccine initiation program and the quality of the decision making to get vaccinated, as measured by knowledge, attitudes, beliefs, and self-efficacy toward HPV vaccination.
METHODS


This quasi-experimental study was conducted on 128 students randomly allocated to intervention and control groups. This research was conducted in junior high schools. The intervention group received the health education ""Takespro HPV"" intervention through videos and booklets for 6 months at school. Participants in the control group received usual care from the school. Data were collected using a questionnaire of knowledge, attitudes, beliefs, and self-efficacy about HPV vaccination modified by researchers based on previous research and tested for validity and reliability. Data were analyzed using Mann-Whitney test and independent t-test.
RESULTS


A total of 40 participants were actively enrolled in the intervention group, and 88 were passively enrolled in the control group. The health education that was part of the Takespro HPV intervention improved the knowledge (p < 0.05) and self-efficacy (p < 0.05) of the intervention group compared with the control group. The attitude and belief variables showed no significant difference (p > 0.05). Forty students exhibited the health reproduction savings behavior at schools. However, the savings amount was insufficient to get HPV vaccination at the initiation phase.
CONCLUSION


""Takespro"" HPV intervention can be considered an alternative to increasing the coverage of HPV vaccination in adolescents in Yogyakarta.<br />.",2021,The health education that was part of the Takespro HPV intervention improved the knowledge (p < 0.05) and self-efficacy (p < 0.05) of the intervention group compared with the control group.,"['40 participants were actively enrolled in the intervention group, and 88 were passively enrolled in the control group', 'Forty students exhibited the health reproduction savings behavior at schools', 'junior high schools', '128 students randomly allocated to intervention and control groups', 'adolescents in Yogyakarta.<br ', 'Adolescents']","['reproductive health savings (tabungan kesehatan reproduksi, Takespro', 'Takespro"" HPV intervention', 'health education ""Takespro HPV"" intervention through videos and booklets', 'Takespro HPV intervention', 'usual care from the school']","['self-efficacy', 'coverage of HPV vaccination']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}]",128.0,0.0244339,The health education that was part of the Takespro HPV intervention improved the knowledge (p < 0.05) and self-efficacy (p < 0.05) of the intervention group compared with the control group.,"[{'ForeName': 'Wiwin', 'Initials': 'W', 'LastName': 'Lismidiati', 'Affiliation': 'Department of Pediatric and Maternity Nursing, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Ova', 'Initials': 'O', 'LastName': 'Emilia', 'Affiliation': 'Department of Medical Education and Bioethics, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Widyawati', 'Initials': 'W', 'LastName': 'Widyawati', 'Affiliation': 'Department of Pediatric and Maternity Nursing, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2021.22.2.471']
546,33645308,Including a general practice endorsement letter with the testing kit in the Bowel Cancer Screening Programme: Results of a cluster randomised trial.,"OBJECTIVES


To evaluate the effect of general practitioner endorsement accompanying the screening kit rather than with the invitation letter on participation in the NHS Bowel Cancer Screening Programme and on the socioeconomic gradient in participation in the Programme.
METHODS


The NHS Bowel Cancer Screening Programme in England is delivered via five regional hubs. In early 2016, we carried out a cluster-randomised trial, with hub-day of invitation as the randomisation unit. We randomised 150 hub-days of invitation to the intervention group, GP endorsement on the letter accompanying the guaiac faecal occult blood testing kit (75 hub-days, 197,366 individuals) or control, usual letter (75 hub-days, 197,476 individuals). The endpoint was participation, defined as return of a valid kit within 18 weeks of initial invitation. Because of the cluster randomisation, data were analysed by a hierarchical logistic regression, allowing a random effect for date of invitation. Socioeconomic status was represented by the index of multiple deprivation.
RESULTS


Participation was 59.4% in the intervention group and 58.7% in the control group, a significant difference ( p  = 0.04). There was no heterogeneity of the effect of intervention by index of multiple deprivation. We found that there was some confounding between date and screening episode order (first or subsequent screen). This in turn may have induced confounding with age and slightly diluted the result.
CONCLUSIONS


General practitioner endorsement induces a modest increase in participation in bowel cancer screening, but does not affect the socioeconomic gradient. When considering cluster randomisation as a research method, careful scrutiny of potential confounding is indicated in advance if possible and in analysis otherwise.",2021,"RESULTS


Participation was 59.4% in the intervention group and 58.7% in the control group, a significant difference ( p  = 0.04).",[],"['general practice endorsement letter with the testing kit in the Bowel Cancer Screening Programme', 'GP endorsement on the letter accompanying the guaiac faecal occult blood testing kit', 'general practitioner endorsement accompanying the screening kit rather than with the invitation letter']","['participation in bowel cancer screening', 'Socioeconomic status']",[],"[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0346627', 'cui_str': 'Malignant tumor of intestine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018302', 'cui_str': 'Guaiac'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C0346627', 'cui_str': 'Malignant tumor of intestine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}]",,0.0506986,"RESULTS


Participation was 59.4% in the intervention group and 58.7% in the control group, a significant difference ( p  = 0.04).","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Cross', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myles', 'Affiliation': 'Wolfson Institute for Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Greliak', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, Cancer Institute, University College London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Halloran', 'Affiliation': 'Bowel Cancer Screening Southern Programme Hub, Surrey Research Park, Guildford, UK.'}, {'ForeName': 'Sally C', 'Initials': 'SC', 'LastName': 'Benton', 'Affiliation': 'Bowel Cancer Screening Southern Programme Hub, Surrey Research Park, Guildford, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Addison', 'Affiliation': 'Bowel Cancer Screening North East Programme Hub, Queen Elizabeth Hospital, Gateshead, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'Bowel Cancer Screening Eastern Programme Hub, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Djedovic', 'Affiliation': ""Bowel Cancer Screening London Programme Hub, Northwick Park & St Mark's Hospitals, Harrow, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Bowel Cancer Screening Midlands & North West Programme Hub, Hospital of St Cross, Rugby, UK.'}, {'ForeName': 'Christian von', 'Initials': 'CV', 'LastName': 'Wagner', 'Affiliation': 'Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Wolfson Institute for Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Raine', 'Affiliation': 'Department of Applied Health Research, University College London, London, UK.'}]",Journal of medical screening,['10.1177/0969141321997480']
547,33621921,Exploratory and confirmatory factor analysis of the parental rules toward adolescent drinking questionnaire: Two factors are better than the original one.,"The parental rules toward drinking questionnaire (PRQ; Van der Vorst et al., 2005) assesses strictness toward adolescent drinking situations. The aim of the current study was to address a gap in the literature on the psychometric testing and evaluation of the factor structure of the PRQ. The current sample consisted of Dutch adolescents (N = 2922) who participated in a randomized control trial with three intervention groups (parent, student, and parent + student) and a control. PRQ and frequency of alcohol use (past month and year) were measured at baseline (T1) and 12 months later (T2). Results from Exploratory and Confirmatory Factor Analyses revealed two reliable factors: (a) rules about normative drinking situations and (b) rules about non-normative drinking situations (both αs ≥ 0.88). Regression analyses conducted to examine the prospective effects of the interventions revealed that both parent conditions predicted increases in strictness toward normative drinking situations relative to the control condition, while only the parent + student condition affected the original PRQ (single factor). Further, the normative subscale predicted increases in drinking (past month and year), as did the original PRQ. Significant effects with the normative subscale indicate that rules toward these drinking situations are ones that account for the effects in the original PRQ, and that the original PRQ can mask effects. The results illustrate that the PRQ is multidimensional. The effects of the normative subscale suggest that intervention efforts should focus on preventing drinking situations that parents normally permit their adolescents to engage in.",2021,"Regression analyses conducted to examine the prospective effects of the interventions revealed that both parent conditions predicted increases in strictness toward normative drinking situations relative to the control condition, while only the parent + student condition affected the original PRQ (single factor).","['adolescent drinking questionnaire', 'Dutch adolescents (N\xa0=\xa02922) who participated']",[],['PRQ and frequency of alcohol use (past month and year'],"[{'cui': 'C0684314', 'cui_str': 'Adolescent Alcohol Consumption'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}]",2922.0,0.0149018,"Regression analyses conducted to examine the prospective effects of the interventions revealed that both parent conditions predicted increases in strictness toward normative drinking situations relative to the control condition, while only the parent + student condition affected the original PRQ (single factor).","[{'ForeName': 'Bradley M', 'Initials': 'BM', 'LastName': 'Trager', 'Affiliation': 'Department of Psychology, Loyola Marymount University, Los Angeles, CA, USA. Electronic address: bradley.trager@lmu.edu.'}, {'ForeName': 'Ina M', 'Initials': 'IM', 'LastName': 'Koning', 'Affiliation': 'Interdisciplinary Social Science, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Turrisi', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, USA; Edna Bennett Pierce Prevention Research Center, The Pennsylvania State University, University Park, PA, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.106855']
548,33631763,Study Protocol for the Use of Conventional Open Haemorrhoidectomy versus Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: A Randomized Controlled Trial.,"BACKGROUND


Haemorrhoids result in a variety of symptoms that cause significant patient anxiety. Treatment has long been associated with post-operative complications, which cause significant symptoms and may result in readmissions. The open conventional haemorrhoidectomy (COH) is still regarded as the gold standard treatment for non-circumferential grade II-IV haemorrhoids. Laser haemorrhoidoplasty (LAH) has recently been studied and the initial results appear promising. This study aims to compare these 2 techniques in the treatment of symptomatic haemorrhoids. We hypothesize that LAH has significantly less pain and bleeding and better quality of life (QoL) scores 1, 3 and 12 months post-operatively.
METHODS


A prospective, randomized, double-blind, single-centre clinical trial will be conducted. All patients aged between 21 and 90 years who present with symptomatic grade II-IV haemorrhoids will be recruited. Exclusion criteria include those who have had previous operations for haemorrhoids and those with an increased risk of bleeding. Data collected will include patient demographics, pre- and intra-operative characteristics of the haemorrhoids, operative details and post-operative pain Visual Analogue Scale (VAS) score, complications, readmissions, and haemorrhoid-specific QoL surveys. Primary outcome will be median post-operative pain VAS score on post-operative days (POD) 1-10. Secondary outcomes include operative duration, bleeding on the first 10 days post-operatively, readmissions, procedure-related complications (fistulation, incontinence, stenosis), QoL scores, and recurrence of symptoms up to 12 months.
DISCUSSION


Results from this trial may demonstrate the superiority of LAH over COH in terms of post-operative pain and recovery. This would likely increase the adoption of LAH for the treatment of symptomatic haemorrhoids.
TRIAL REGISTRATION


This trial was registered on 1/4/2020 at ClinicalTrials.gov. URL: https://www.clinicaltrials.gov/ct2/show/NCT04329364?term=NCT04329364&amp;draw=2&amp;rank=1.",2020,The open conventional haemorrhoidectomy (COH) is still regarded as the gold standard treatment for non-circumferential grade II-IV haemorrhoids.,"['symptomatic haemorrhoids', 'All patients aged between 21 and 90 years who present with symptomatic grade II-IV haemorrhoids will be recruited', 'Symptomatic Haemorrhoids']","['LAH', 'Conventional Open Haemorrhoidectomy versus Laser Haemorrhoidoplasty', 'conventional haemorrhoidectomy (COH', 'Laser haemorrhoidoplasty (LAH']","['pain and bleeding and better quality of life (QoL) scores', 'median post-operative pain VAS score on post-operative days (POD) 1-10', 'operative duration, bleeding on the first 10 days post-operatively, readmissions, procedure-related complications (fistulation, incontinence, stenosis), QoL scores, and recurrence of symptoms up to 12 months', 'risk of bleeding', 'operative pain Visual Analogue Scale (VAS) score, complications, readmissions, and haemorrhoid-specific QoL surveys']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0473074', 'cui_str': 'Open hemorrhoidectomy'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.366162,The open conventional haemorrhoidectomy (COH) is still regarded as the gold standard treatment for non-circumferential grade II-IV haemorrhoids.,"[{'ForeName': 'Frederick H', 'Initials': 'FH', 'LastName': 'Koh', 'Affiliation': 'Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore, frederickkohhx@gmail.com.'}, {'ForeName': 'Fung Joon', 'Initials': 'FJ', 'LastName': 'Foo', 'Affiliation': 'Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Ho', 'Affiliation': 'Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore.'}, {'ForeName': 'Sharmini S', 'Initials': 'SS', 'LastName': 'Sivarajah', 'Affiliation': 'Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore.'}, {'ForeName': 'Winson J', 'Initials': 'WJ', 'LastName': 'Tan', 'Affiliation': 'Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore.'}, {'ForeName': 'Min-Hoe', 'Initials': 'MH', 'LastName': 'Chew', 'Affiliation': 'Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore.'}]",European surgical research. Europaische chirurgische Forschung. Recherches chirurgicales europeennes,['10.1159/000513844']
549,33639045,Effect of vitamin K2 and vitamin D3 on bone mineral density in children with acute lymphoblastic leukemia: a prospective cohort study.,"OBJECTIVES


Current treatment protocols in acute lymphoblastic leukemia (ALL) are associated with high remission rates and long life expectancy, enhancing the importance of quality of life and prevention of treatment-related complications in patient care. As osteoporosis is a frequent complication in patients under chemotherapy, we investigated the effect of vitamin K2 (100 mcg menaquinone-7) and vitamin D3 (10 mcg calcitriol) on bone metabolism in children with ALL.
METHODS


Twenty-nine consecutive patients recently diagnosed with B precursor ALL (B-ALL) and treated according to the Turkish Acute Lymphoblastic Leukemia Berlin Frankfurt Münster 2000 protocol were randomly assigned into study and control groups. The study group (n=15, M/F: 8/7, age 1-14.5 years, mean 6.5 years) received vitamin K2 and vitamin D3 with their chemotherapy, while the control group (n=14, M/F 9/5, age 2-17 years, mean 7.1 years) received chemotherapy only. Serum calcium, phosphorus, magnesium, alkaline phosphatase, bone-specific alkaline phosphatase, uncarboxylated osteocalcin (ucOC), tartrate resistant acid phosphatase 5b, carboxyl terminal procollagen propeptide (PICP), osteoprotegerin (OPG), and receptor activator nuclear kappa B ligand (RANKL) were measured and bone mineral density (BMD) was determined at baseline and first, second, third and sixth months.
RESULTS


The study group had higher serum OPG/RANKL ratio and lower ucOC levels compared to the control group at the first month; PICP levels were higher in the study group at second and third months.
CONCLUSIONS


These results suggest an early beneficial effect of the combination of vitamin K2 and vitamin D3 on BMD in ALL patients especially during the period of intensive steroid therapy in the first months.",2021,"The study group had higher serum OPG/RANKL ratio and lower ucOC levels compared to the control group at the first month; PICP levels were higher in the study group at second and third months.
","['acute lymphoblastic leukemia (ALL', 'children with ALL', 'The study group (n=15, M/F: 8/7, age 1-14.5\xa0years, mean 6.5\xa0years) received', 'Twenty-nine consecutive patients recently diagnosed with B precursor ALL (B-ALL) and treated according to the Turkish Acute Lymphoblastic Leukemia Berlin Frankfurt Münster 2000 protocol', 'children with acute lymphoblastic leukemia', 'patients under chemotherapy']","['vitamin K2 and vitamin D3 with their chemotherapy', 'vitamin K2 and vitamin D3', 'chemotherapy only', 'vitamin K2 (100 mcg menaquinone-7) and vitamin D3 (10 mcg calcitriol']","['Serum calcium, phosphorus, magnesium, alkaline phosphatase, bone-specific alkaline phosphatase, uncarboxylated osteocalcin (ucOC), tartrate resistant acid phosphatase 5b, carboxyl terminal procollagen propeptide (PICP), osteoprotegerin (OPG), and receptor activator nuclear kappa B ligand (RANKL) were measured and bone mineral density (BMD', 'higher serum OPG/RANKL ratio and lower ucOC levels', 'bone mineral density', 'bone metabolism', 'PICP levels']","[{'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0349636', 'cui_str': 'Pre B-cell acute lymphoblastic leukemia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0078382', 'cui_str': 'vitamin MK 7'}, {'cui': 'C0006674', 'cui_str': 'Calcitriol'}]","[{'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C4543210', 'cui_str': 'Receptor activator'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0072052', 'cui_str': 'procollagen type I carboxy terminal peptide'}]",29.0,0.0269171,"The study group had higher serum OPG/RANKL ratio and lower ucOC levels compared to the control group at the first month; PICP levels were higher in the study group at second and third months.
","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Solmaz', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Department of Pediatrics, Faculty of Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Mehmet Akif', 'Initials': 'MA', 'LastName': 'Ozdemir', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Department of Pediatrics, Faculty of Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Ekrem', 'Initials': 'E', 'LastName': 'Unal', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Department of Pediatrics, Faculty of Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Ummuhan', 'Initials': 'U', 'LastName': 'Abdurrezzak', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Sebahattin', 'Initials': 'S', 'LastName': 'Muhtaroglu', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Karakukcu', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Department of Pediatrics, Faculty of Medicine, Erciyes University, Kayseri, Turkey.'}]",Journal of pediatric endocrinology & metabolism : JPEM,['10.1515/jpem-2020-0637']
550,33646423,The effects of normoxic endurance exercise on erythropoietin (EPO) production and the impact of selective β 1  and non-selective β 1  + β 2  adrenergic receptor blockade.,"PURPOSE


Habitual endurance exercise results in increased erythropoiesis, which is primarily controlled by erythropoietin (EPO), yet studies demonstrating upregulation of EPO via a single bout of endurance exercise have been equivocal. This study compares the acute EPO response to 30 min of high versus 90 min of moderate-intensity endurance exercise and whether that response can be upregulated via selective adrenergic receptor blockade.
METHODS


Using a counterbalanced, cross-over design, fifteen participants (age 28 ± 8) completed two bouts of running (30-min, high intensity vs 90-min, moderate intensity) matched for overall training stress. A separate cohort of fourteen participants (age 31 ± 6) completed three bouts of 30-min high-intensity cycling after ingesting the preferential β 1 -adrenergic receptor (AR) antagonist bisoprolol, the non-preferential β 1  + β 2  antagonist nadolol or placebo. Venous blood was collected before, during, and after exercise, and serum EPO levels were determined by ELISA.
RESULTS


No detectable EPO response was observed during or after high intensity running, however, in the moderate-intensity trial EPO was significantly elevated at both during-exercise timepoints (+ 6.8% ± 2.3% at 15 min and + 8.7% ± 2.2% at 60 min). No significant change in EPO was observed post-cycling or between the trials involving βAR blockade.
CONCLUSION


Neither training mode (running or cycling), nor beta-blockade significantly influenced the EPO response to 30 min of high-intensity exercise, however, 90 min of moderate-intensity running elevated EPO during exercise, returning to baseline immediately post-exercise. Identifying the optimal mode, duration and intensity required to evoke an EPO response to exercise may help tailor exercise prescriptions designed to maximize EPO response for both performance and clinical applications.",2021,"Neither training mode (running or cycling), nor beta-blockade significantly influenced the EPO response to 30 min of high-intensity exercise, however, 90 min of moderate-intensity running elevated EPO during exercise, returning to baseline immediately post-exercise.","['fifteen participants (age 28\u2009±\u20098) completed two', 'fourteen participants (age 31\u2009±\u20096) completed three']","['Habitual endurance exercise', 'normoxic endurance exercise', 'bouts of 30-min high-intensity cycling after ingesting the preferential β 1 -adrenergic receptor (AR) antagonist bisoprolol, the non-preferential β 1  +\u2009β 2  antagonist nadolol or placebo', 'bouts of running (30-min, high intensity vs 90-min, moderate intensity) matched for overall training stress']","['EPO response', 'erythropoietin (EPO) production', 'Venous blood', 'moderate-intensity trial EPO', 'EPO', 'acute EPO response', 'serum EPO levels']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0242889', 'cui_str': 'Substance with adrenergic receptor antagonist mechanism of action'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0027302', 'cui_str': 'Nadolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement'}]",15.0,0.038041,"Neither training mode (running or cycling), nor beta-blockade significantly influenced the EPO response to 30 min of high-intensity exercise, however, 90 min of moderate-intensity running elevated EPO during exercise, returning to baseline immediately post-exercise.","[{'ForeName': 'Rod J', 'Initials': 'RJ', 'LastName': 'Azadan', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, 3875 Holman Street, Houston, TX, 77204, USA.'}, {'ForeName': 'Nadia H', 'Initials': 'NH', 'LastName': 'Agha', 'Affiliation': 'Department of Molecular Physiology and Biophysics, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Hawley E', 'Initials': 'HE', 'LastName': 'Kunz', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Forrest L', 'Initials': 'FL', 'LastName': 'Baker', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, 3875 Holman Street, Houston, TX, 77204, USA.'}, {'ForeName': 'Preteesh L', 'Initials': 'PL', 'LastName': 'Mylabathula', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, 3875 Holman Street, Houston, TX, 77204, USA.'}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Ledoux', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, 3875 Holman Street, Houston, TX, 77204, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': ""O'Connor"", 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, 3875 Holman Street, Houston, TX, 77204, USA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Pedlar', 'Affiliation': ""Faculty of Sport, Health and Applied Science, St Mary's University, Twickenham, England, UK.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Simpson', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, 3875 Holman Street, Houston, TX, 77204, USA. rjsimpson@arizona.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04558-4']
551,33639559,The combination of feedback and modeling in online simulation training of child sexual abuse interviews improves interview quality in clinical psychologists.,"BACKGROUND


Previous research has shown the effectiveness of simulation training using avatars paired with feedback in improving child sexual abuse interview quality. However, it has room for improvement.
OBJECTIVE


The present study aimed to determine if the combination of two interventions, feedback and modeling, would further improve interview quality compared to either intervention alone.
PARTICIPANTS


Thirty-two clinical psychologists were randomly assigned to a feedback, modeling, or the combination of feedback and modeling group.
METHODS


The participants conducted five simulated child sexual abuse interviews online while receiving the intervention(s) corresponding to their allocated group. Feedback was provided after each interview and consisted of the outcome of the alleged cases and comments on the quality of the questions asked in the interviews. Modeling was provided after the 1st interview and consisted of learning points and videos illustrating good and bad questioning methods.
RESULTS


The proportion of recommended questions improved over the five interviews when considering all groups combined. The combined intervention (vs. feedback alone) showed a higher proportion of recommended questions from the 2nd interview onward while the difference between the combined intervention and modeling alone and the difference between the modeling alone and feedback alone were mostly not significant. The number of correct details were affected in the same way. No significant differences in the number of incorrect details were found.
CONCLUSIONS


The results show that the combination of feedback and modeling achieves improvement greater than that of feedback alone.",2021,The combined intervention (vs. feedback alone) showed a higher proportion of recommended questions from the 2nd interview onward while the difference between the combined intervention and modeling alone and the difference between the modeling alone and feedback alone were mostly not significant.,"['child sexual abuse interviews improves interview quality in clinical psychologists', 'Thirty-two clinical psychologists']","['feedback, modeling, or the combination of feedback and modeling group', 'feedback and modeling in online simulation training']","['number of incorrect details', 'number of correct details', 'interview quality', 'child sexual abuse interview quality']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0237412', 'cui_str': 'Clinical psychologist'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}]",,0.0193637,The combined intervention (vs. feedback alone) showed a higher proportion of recommended questions from the 2nd interview onward while the difference between the combined intervention and modeling alone and the difference between the modeling alone and feedback alone were mostly not significant.,"[{'ForeName': 'Shumpei', 'Initials': 'S', 'LastName': 'Haginoya', 'Affiliation': 'Faculty of Arts and Sciences, NYU Shanghai, Shanghai, China; Life Skill Education Institute, Graduate School of Hosei University, Tokyo, Japan. Electronic address: shumpei.haginoya@nyu.edu.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Forensic Science Laboratory, Hokkaido Prefectural Police Headquarters, Hokkaido, Japan.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Santtila', 'Affiliation': 'Faculty of Arts and Sciences, NYU Shanghai, Shanghai, China.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.105013']
552,33625893,Can Technology-Based Physical Activity Programs for Chronic Obstructive Pulmonary Disease Be Cost-Effective?,"Objective:  To evaluate the cost-effectiveness of a technology-based physical activity (PA) intervention for chronic obstructive pulmonary disease (COPD).  Design:  A secondary data analysis was performed from a randomized controlled trial in COPD of an activity monitor alone or an activity monitor plus a web-based PA intervention. Models estimated cost per quality-adjusted life year (QALY) and incremental cost-effectiveness ratios (ICERs) compared with usual care.  Results:  The estimated ICER for both groups was below the willingness-to-pay threshold of $50,000/QALY (activity monitor alone = $10,437/QALY; website plus activity monitor intervention = $13,065/QALY). A probabilistic simulation estimated 76% of the activity monitor-alone group and 78% of the intervention group simulations to be cost-effective.  Conclusion(s):  Both the activity monitor-alone group and the activity monitor plus website group were cost-effective at the base case by using conventional willingness-to-pay thresholds. Further research would benefit from a more direct estimate of health utilities and downstream health care costs. Clinical Trials.gov NCT01102777.",2021,Both the activity monitor-alone group and the activity monitor plus website group were cost-effective at the base case by using conventional willingness-to-pay thresholds.,['chronic obstructive pulmonary disease (COPD'],"['technology-based physical activity (PA) intervention', 'activity monitor plus a web-based PA intervention']","['cost per quality-adjusted life year (QALY) and incremental cost-effectiveness ratios (ICERs', 'cost-effectiveness', 'cost-effective']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0406313,Both the activity monitor-alone group and the activity monitor plus website group were cost-effective at the base case by using conventional willingness-to-pay thresholds.,"[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Ney', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Bedford Healthcare System, Bedford, Massachusetts, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Robinson', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Bedford Healthcare System, Bedford, Massachusetts, USA.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0398']
553,33622389,"Oxytocin-induced increase in N,N-dimethylglycine and time course of changes in oxytocin efficacy for autism social core symptoms.","BACKGROUND


Oxytocin is expected as a novel therapeutic agent for autism spectrum disorder (ASD) core symptoms. However, previous results on the efficacy of repeated administrations of oxytocin are controversial. Recently, we reported time-course changes in the efficacy of the neuropeptide underlying the controversial effects of repeated administration; however, the underlying mechanisms remained unknown.
METHODS


The current study explored metabolites representing the molecular mechanisms of oxytocin's efficacy using high-throughput metabolomics analysis on plasma collected before and after 6-week repeated intranasal administration of oxytocin (48 IU/day) or placebo in adult males with ASD (N = 106) who participated in a multi-center, parallel-group, double-blind, placebo-controlled, randomized controlled trial.
RESULTS


Among the 35 metabolites measured, a significant increase in N,N-dimethylglycine was detected in the subjects administered oxytocin compared with those given placebo at a medium effect size (false discovery rate (FDR) corrected P = 0.043, d = 0.74, N = 83). Furthermore, subgroup analyses of the participants displaying a prominent time-course change in oxytocin efficacy revealed a significant effect of oxytocin on N,N-dimethylglycine levels with a large effect size (P FDR  = 0.004, d = 1.13, N = 60). The increase in N,N-dimethylglycine was significantly correlated with oxytocin-induced clinical changes, assessed as changes in quantifiable characteristics of autistic facial expression, including both of improvements between baseline and 2 weeks (P FDR  = 0.006, r = - 0.485, N = 43) and deteriorations between 2 and 4 weeks (P FDR  = 0.032, r = 0.415, N = 37).
LIMITATIONS


The metabolites changes caused by oxytocin administration were quantified using peripheral blood and therefore may not directly reflect central nervous system changes.
CONCLUSION


Our findings demonstrate an association of N,N-dimethylglycine upregulation with the time-course change in the efficacy of oxytocin on autistic social deficits. Furthermore, the current findings support the involvement of the N-methyl-D-aspartate receptor and neural plasticity to the time-course change in oxytocin's efficacy.
TRIAL REGISTRATION


A multi-center, parallel-group, placebo-controlled, double-blind, confirmatory trial of intranasal oxytocin in participants with autism spectrum disorders (the date registered: 30 October 2014; UMIN Clinical Trials Registry: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017703 ) (UMIN000015264).",2021,"Among the 35 metabolites measured, a significant increase in N,N-dimethylglycine was detected in the subjects administered oxytocin compared with those given placebo at a medium effect size (false discovery rate (FDR) corrected P = 0.043, d = 0.74, N = 83).","['participants with autism spectrum disorders (the date registered: 30 October 2014', 'adult males with ASD (N\u2009=\u2009106) who participated in a multi-center, parallel-group, double-blind']","['oxytocin', 'intranasal oxytocin', 'placebo', 'Oxytocin']","['autistic facial expression', 'autistic social deficits', 'N,N-dimethylglycine', 'oxytocin efficacy']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C3499933', 'cui_str': 'N,N-dimethylglycine'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.424293,"Among the 35 metabolites measured, a significant increase in N,N-dimethylglycine was detected in the subjects administered oxytocin compared with those given placebo at a medium effect size (false discovery rate (FDR) corrected P = 0.043, d = 0.74, N = 83).","[{'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City, 431-3192, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City, 431-3192, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Okada', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Munesue', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Seico', 'Initials': 'S', 'LastName': 'Benner', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City, 431-3192, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Kuroda', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kojima', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Yassin', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Eriguchi', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Kameno', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City, 431-3192, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Murayama', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City, 431-3192, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Nishimura', 'Affiliation': 'United Graduate School of Child Development, Osaka University, Kanazawa University, Hamamatsu University School of Medicine, Chiba University and University of Fukui, Osaka/Kanazawa/Hamamatsu/Chiba/Fukui, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': 'United Graduate School of Child Development, Osaka University, Kanazawa University, Hamamatsu University School of Medicine, Chiba University and University of Fukui, Osaka/Kanazawa/Hamamatsu/Chiba/Fukui, Japan.'}, {'ForeName': 'Kiyoto', 'Initials': 'K', 'LastName': 'Kasai', 'Affiliation': 'Department of Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ozaki', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Kosaka', 'Affiliation': 'Department of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui, Eiheiji, Fukui, 910-1193, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Yamasue', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City, 431-3192, Japan. yamasue@hama-med.ac.jp.'}]",Molecular autism,['10.1186/s13229-021-00423-z']
554,33629376,Vegan dietary pattern for the primary and secondary prevention of cardiovascular diseases.,"BACKGROUND


Diet plays a major role in the aetiology of cardiovascular disease (CVD) and as a modifiable risk factor is the focus of many prevention strategies. Recently vegan diets have gained popularity and there is a need to synthesise existing clinical trial evidence for their potential in CVD prevention.
OBJECTIVES


To determine the effectiveness of following a vegan dietary pattern for the primary and secondary prevention of CVD.
SEARCH METHODS


We searched the following electronic databases on 4 February 2020: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Web of Science Core Collection. We also searched ClinicalTrials.gov in January 2021. We applied no language restrictions.
SELECTION CRITERIA


We selected randomised controlled trials (RCTs) in healthy adults and adults at high risk of CVD (primary prevention) and those with established CVD (secondary prevention). A vegan dietary pattern excludes meat, fish, eggs, dairy and honey; the intervention could be dietary advice, provision of relevant foods, or both. The comparison group received either no intervention, minimal intervention, or another dietary intervention. Outcomes included clinical events and CVD risk factors. We included only studies with follow-up periods of 12 weeks or more, defined as the intervention period plus post-intervention follow-up.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed studies for inclusion, extracted data and assessed risks of bias. We used GRADE to assess the certainty of the evidence. We conducted three main comparisons: 1. Vegan dietary intervention versus no intervention or minimal intervention for primary prevention; 2. Vegan dietary intervention versus another dietary intervention for primary prevention; 3. Vegan dietary intervention versus another dietary intervention for secondary prevention.
MAIN RESULTS


Thirteen RCTs (38 papers, 7 trial registrations) and eight ongoing trials met our inclusion criteria. Most trials contributed to primary prevention: comparisons 1 (four trials, 466 participants randomised) and comparison 2 (eight trials, 409 participants randomised). We included only one secondary prevention trial for comparison 3 (63 participants randomised). None of the trials reported on clinical endpoints. Other primary outcomes included lipid levels and blood pressure. For comparison 1 there was moderate-certainty evidence from four trials with 449 participants that a vegan diet probably led to a small reduction in total cholesterol (mean difference (MD) -0.24 mmol/L, 95% confidence interval (CI) -0.36 to -0.12) and low-density lipoprotein (LDL) cholesterol (MD -0.22 mmol/L, 95% CI -0.32 to -0.11), a very small decrease in high-density lipoprotein (HDL) levels (MD -0.08 mmol/L, 95% CI -0.11 to -0.04) and a very small increase in triglyceride levels (MD 0.11 mmol/L, 95% CI 0.01 to 0.21). The very small changes in HDL and triglyceride levels are in the opposite direction to that expected. There was a lack of evidence for an effect with the vegan dietary intervention on systolic blood pressure (MD 0.94 mmHg, 95% CI -1.18 to 3.06; 3 trials, 374 participants) and diastolic blood pressure (MD -0.27 mmHg, 95% CI -1.67 to 1.12; 3 trials, 372 participants) (low-certainty evidence). For comparison 2 there was a lack of evidence for an effect of the vegan dietary intervention on total cholesterol levels (MD -0.04 mmol/L, 95% CI -0.28 to 0.20; 4 trials, 163 participants; low-certainty evidence). There was probably little or no effect of the vegan dietary intervention on LDL (MD -0.05 mmol/L, 95% CI -0.21 to 0.11; 4 trials, 244 participants) or HDL cholesterol levels (MD -0.01 mmol/L, 95% CI -0.08 to 0.05; 5 trials, 256 participants) or triglycerides (MD 0.21 mmol/L, 95% CI -0.07 to 0.49; 5 trials, 256 participants) compared to other dietary interventions (moderate-certainty evidence). We are very uncertain about any effect of the vegan dietary intervention on systolic blood pressure (MD 0.02 mmHg, 95% CI -3.59 to 3.62)  or diastolic blood pressure (MD 0.63 mmHg, 95% CI -1.54 to 2.80; 5 trials, 247 participants (very low-certainty evidence)). Only one trial (63 participants) contributed to comparison 3, where there was a lack of evidence for an effect of the vegan dietary intervention on lipid levels or blood pressure compared to other dietary interventions (low- or very low-certainty evidence). Four trials reported on adverse events, which were absent or minor.
AUTHORS' CONCLUSIONS


Studies were generally small with few participants contributing to each comparison group. None of the included studies report on CVD clinical events. There is currently insufficient information to draw conclusions about the effects of vegan dietary interventions on CVD risk factors. The eight ongoing studies identified will add to the evidence base, with all eight reporting on primary prevention. There is a paucity of evidence for secondary prevention.",2021,"There was a lack of evidence for an effect with the vegan dietary intervention on systolic blood pressure (MD 0.94 mmHg, 95% CI -1.18 to 3.06; 3 trials, 374 participants) and diastolic blood pressure (MD -0.27 mmHg, 95% CI -1.67 to 1.12; 3 trials, 372 participants) (low-certainty evidence).","['healthy adults and adults at high risk of CVD (primary prevention) and those with established CVD (secondary prevention', 'primary prevention', '466 participants randomised) and comparison 2 (eight trials, 409 participants randomised']","['vegan dietary intervention', 'vegan dietary interventions', 'no intervention, minimal intervention, or another dietary intervention', 'Vegan dietary intervention versus another dietary intervention', 'Vegan dietary intervention versus no intervention or minimal intervention']","['HDL and triglyceride levels', 'systolic blood pressure', 'cardiovascular diseases', 'high-density lipoprotein (HDL) levels', 'total cholesterol levels', 'HDL cholesterol levels', 'low-density lipoprotein (LDL) cholesterol', 'clinical events and CVD risk factors', 'lipid levels or blood pressure', 'triglyceride levels', 'adverse events', 'lipid levels and blood pressure', 'diastolic blood pressure', 'LDL', 'total cholesterol']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0679699', 'cui_str': 'Secondary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",63.0,0.333201,"There was a lack of evidence for an effect with the vegan dietary intervention on systolic blood pressure (MD 0.94 mmHg, 95% CI -1.18 to 3.06; 3 trials, 374 participants) and diastolic blood pressure (MD -0.27 mmHg, 95% CI -1.67 to 1.12; 3 trials, 372 participants) (low-certainty evidence).","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rees', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Al-Khudairy', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Takeda', 'Affiliation': 'Cochrane ENT, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Stranges', 'Affiliation': 'Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013501.pub2']
555,33638016,A comparison of foam rolling and vibration foam rolling on the quadriceps muscle function and mechanical properties.,"PURPOSE


The purpose of the study was to investigate the effects of using a vibration foam roll (VFR) or a non-vibration foam roll (NVFR) on maximum voluntary isometric contraction peak torque (MVIC), range of motion (ROM), passive resistive torque (PRT), and shear modulus.
METHODS


Twenty-one male volunteers visited the laboratory on two separate days and were randomly assigned to either a VFR group or a NVFR group. Both interventions were performed for 3 × 1 min each. Before and after each intervention, passive resistive torque and maximum voluntary isometric contraction peak torque of the leg extensors were assessed with a dynamometer. Hip extension ROM was assessed using a modified Thomas test with 3D-motion caption. Muscle shear modulus of the vastus lateralis (VL), vastus medialis (VM), and rectus femoris (RF) was assessed with shear wave elastography (SWE).
RESULTS


In both groups (VFR, NVFR) we observed an increase in MVIC peak torque (+ 14.2 Nm, + 8.6 Nm) and a decrease in shear modulus of the RF (- 7.2 kPa, - 4.7 kPa). However, an increase in hip extension ROM (3.3°) was only observed in the VFR group. There was no change in PRT and shear modulus of the VL and VM, in both the VFR group and the NVFR group. Our findings demonstrate a muscle-specific acute decrease in passive RF stiffness after VFR and NVFR, with an effect on joint flexibility found only after VFR.
CONCLUSION


The findings of this study suggest that VFR might be a more efficient approach to maximize performance in sports with flexibility demands.",2021,"There was no change in PRT and shear modulus of the VL and VM, in both the VFR group and the NVFR group.",['Twenty-one male volunteers visited the laboratory on two separate days'],"['VFR', 'foam rolling and vibration foam rolling', 'vibration foam roll (VFR) or a non-vibration foam roll (NVFR', 'NVFR', 'passive resistive torque and maximum voluntary isometric contraction peak torque of the leg extensors were assessed with a dynamometer']","['MVIC peak torque', 'Muscle shear modulus of the vastus lateralis (VL), vastus medialis (VM), and rectus femoris (RF', 'hip extension ROM', 'PRT and shear modulus of the VL and VM', 'maximum voluntary isometric contraction peak torque (MVIC), range of motion (ROM), passive resistive torque (PRT), and shear modulus', 'joint flexibility', 'shear wave elastography (SWE', 'Hip extension ROM', 'passive RF stiffness', 'shear modulus of the RF']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",21.0,0.0242902,"There was no change in PRT and shear modulus of the VL and VM, in both the VFR group and the NVFR group.","[{'ForeName': 'Marina Maren', 'Initials': 'MM', 'LastName': 'Reiner', 'Affiliation': 'Institute of Human Movement Science, Sport and Health, University of Graz, Mozartgasse 14, 8010, Graz, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Glashüttner', 'Affiliation': 'Institute of Human Movement Science, Sport and Health, University of Graz, Mozartgasse 14, 8010, Graz, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bernsteiner', 'Affiliation': 'Institute of Human Movement Science, Sport and Health, University of Graz, Mozartgasse 14, 8010, Graz, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Tilp', 'Affiliation': 'Institute of Human Movement Science, Sport and Health, University of Graz, Mozartgasse 14, 8010, Graz, Austria.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Guilhem', 'Affiliation': 'French Institute of Sport (INSEP), Laboratory Sport, Expertise and Performance (EA 7370), Paris, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Morales-Artacho', 'Affiliation': 'French Institute of Sport (INSEP), Laboratory Sport, Expertise and Performance (EA 7370), Paris, France.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Konrad', 'Affiliation': 'Institute of Human Movement Science, Sport and Health, University of Graz, Mozartgasse 14, 8010, Graz, Austria. andreas.konrad@uni-graz.at.'}]",European journal of applied physiology,['10.1007/s00421-021-04619-2']
556,33648870,Frequency of Intradialytic Hypotension Events Do Not Increase with Oral Nutritional Supplementation during Hemodialysis Treatment: A Randomized Controlled Trial.,"OBJECTIVE


This study aimed to compare the effect of the use of a renal-specific oral nutritional supplement (RS-ONS) during hemodialysis sessions and the use of RS-ONS at home on the incidence of intradialytic hypotension.
METHODS


A single-center, 12-week, open-label, randomized controlled clinical trial was conducted. The intervention was a RN-ONS divided into two portions: 100 and 137 mL. The first portion was given after 1 hour of hemodialysis (HD) treatment, while the second portion was given 45 minutes before the end of HD. The research staff registered the baseline and final nutritional parameters and systolic arterial pressure (SAP) from the screen of the HD device during 36 HD sessions. Hypotension symptoms were also recorded every hour during each HD session. The nutritional and functional status was also assessed.
RESULTS


We registered a total of 16 hypotensive events during 1082 HD sessions: 9 were in patients supplemented at home (551 HD sessions) and 7 occurred in patients supplemented during HD P = .668. Incidence of intradialytic hypotension (IH) during 1082 HD sessions was 1.4%. The total malnutrition inflammation score (MIS) decreased in both groups (P < .01), and the percentage of cachexia improved in the supplemented-during-HD group (P < .05).
CONCLUSIONS


In this randomized controlled trial, intradialytic hypotension events did not increase with the RS-ONS during HD treatment. This strategy appears to be a safe anabolic nutritional strategy for the prevention of PEW, selecting stable patients and administering a fractioned volume of the supplement after the first hour of HD treatment. More studies with larger samples size are required to confirm these findings.",2021,"The total malnutrition inflammation score (MIS) decreased in both groups (P < .01), and the percentage of cachexia improved in the supplemented-during-HD group (P < .05).
",['Hemodialysis Treatment'],"['renal-specific oral nutritional supplement (RS-ONS', 'Oral Nutritional Supplementation']","['intradialytic hypotension events', 'Hypotension symptoms', 'systolic arterial pressure (SAP', 'Incidence of intradialytic hypotension (IH', 'total malnutrition inflammation score (MIS', 'percentage of cachexia']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}]",,0.0241641,"The total malnutrition inflammation score (MIS) decreased in both groups (P < .01), and the percentage of cachexia improved in the supplemented-during-HD group (P < .05).
","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Ramos-Acevedo', 'Affiliation': 'Nephrology and Mineral Metabolism Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City.'}, {'ForeName': 'Ailema', 'Initials': 'A', 'LastName': 'González-Ortiz', 'Affiliation': 'Nephrology and Mineral Metabolism Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City.'}, {'ForeName': 'Aurora E', 'Initials': 'AE', 'LastName': 'Serralde-Zúñiga', 'Affiliation': 'Clinical Nutrition Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Colín-Ramírez', 'Affiliation': 'Research Associate, Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Miranda-Alatriste', 'Affiliation': 'Nephrology and Mineral Metabolism Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'López-Cisneros', 'Affiliation': 'Nephrology and Mineral Metabolism Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City.'}, {'ForeName': 'Norberto', 'Initials': 'N', 'LastName': 'Rodríguez-González', 'Affiliation': 'Nephrology and Mineral Metabolism Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'Nephrology and Mineral Metabolism Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City.'}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'Atilano-Carsi', 'Affiliation': 'Nephrology and Mineral Metabolism Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City.'}, {'ForeName': 'Ángeles', 'Initials': 'Á', 'LastName': 'Espinosa-Cuevas', 'Affiliation': 'Nephrology and Mineral Metabolism Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City. Electronic address: angeles.espinosac@incmnsz.mx.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2020.10.002']
557,33637427,Impact of a nurse-led family support intervention on family members' satisfaction with intensive care and psychological wellbeing: A mixed-methods evaluation.,"BACKGROUND


Families of critically ill persons face uncertainty and experience distress during and after their close other's stay in an intensive care unit (ICU). Proactive nurse engagement and support is recommended to meet families' needs in the ICU, but little is known about its impact on quality of family care. We introduced a family support intervention that consisted of an interprofessional family support pathway and a new role of an advanced practice family nurse.
OBJECTIVES


The aim of the study was to examine the effect of an advanced practice nurse-led family support intervention on family members' satisfaction, wellbeing, and psychological distress.
METHODS


We conducted a quasi-experimental before-and-after study with embedded qualitative interviews in a Swiss University Hospital from March 2018 to July 2019 using a questionnaire (Family Satisfaction in the ICU-24 Survey, Hospital Anxiety and Depression Scale, and Impact of Event Scale-Revised-6) and qualitative interviews (n = 19) after patient discharge.
RESULTS


Families in the intervention group (n = 75) showed a trend for increased overall satisfaction (difference of 5.544, 95% confidence interval [CI]: -0.11 to 11.20), a statistically significant increase in satisfaction with decision-making (7.258, 95% CI: 0.89 to 13.63), and a nonsignificant increase in satisfaction with care (4.178, 95% CI: -1.53 to 9.89). Psychological distress was higher in the intervention group, with depression reaching statistical significance (difference of 1.706, 95% CI: 0.16 to 3.25), which may be explained by longer ICU stays and higher proportion of deaths in the intervention group. Families receiving the intervention reported to be feeling cared for, well informed, and better able to cope. Data integration suggests that early onset, fit to need, and quality of intervention were the most important intervention characteristics impacting family wellbeing.
CONCLUSIONS


Our study found that family members experience a nurse-led support intervention as beneficial for their wellbeing. It increased their satisfaction, but was unable to demonstrate a favourable impact on psychological distress.",2021,"Psychological distress was higher in the intervention group, with depression reaching statistical significance (difference of 1.706, 95% CI: 0.16 to 3.25), which may be explained by longer ICU stays and higher proportion of deaths in the intervention group.","['quasi-experimental before-and-after study with embedded qualitative interviews in a Swiss University Hospital from March 2018 to July 2019 using a questionnaire (Family Satisfaction in the ICU-24\xa0Survey, Hospital Anxiety and Depression Scale, and Impact of Event Scale-Revised-6) and qualitative interviews (n\xa0=\xa019) after patient discharge', ""family members' satisfaction with intensive care and psychological wellbeing""]","['advanced practice nurse-led family support intervention', 'nurse-led family support intervention']","['satisfaction with decision-making', 'Psychological distress', 'overall satisfaction', 'satisfaction with care', 'psychological distress']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C3472482', 'cui_str': 'Impact of event scale revised'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0545307,"Psychological distress was higher in the intervention group, with depression reaching statistical significance (difference of 1.706, 95% CI: 0.16 to 3.25), which may be explained by longer ICU stays and higher proportion of deaths in the intervention group.","[{'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Naef', 'Affiliation': 'Centre of Clinical Nursing Science, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland; Institute for Implementation Science in Health Care, Faculty of Medicine, University of Zurich, Universitätsstrasse 84, 8006 Zurich, Switzerland. Electronic address: rahel.naef@usz.ch.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'von Felten', 'Affiliation': 'Department of Biostatistics, Institute of Epidemiology, Biostatistics, and Prevention, Faculty of Medicine, University of Zurich, Hirschengraben 84, 8001 Zurich, Switzerland. Electronic address: stefanie.vonfelten@uzh.ch.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Petry', 'Affiliation': 'Centre of Clinical Nursing Science, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland. Electronic address: heidi.petry@usz.ch.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Ernst', 'Affiliation': 'Centre of Clinical Nursing Science, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland. Electronic address: jutta.ernst@usz.ch.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Massarotto', 'Affiliation': 'Institute of Intensive Medicine, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland. Electronic address: paola.massarotto@usz.ch.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2020.10.014']
558,33645253,Precision and accuracy of hyperglycemic clamps in a multicenter study.,"Application of glucose clamp methodologies in multicenter studies brings challenges for standardization. The Restoring Insulin Secretion (RISE) Consortium implemented a hyperglycemic clamp protocol across seven centers using a combination of technical and management approaches to achieve standardization. Two-stage hyperglycemic clamps with glucose targets of 200 mg/dL and >450 mg/dL were performed utilizing a centralized spreadsheet-based algorithm that guided dextrose infusion rates using bedside plasma glucose measurements. Clamp operators received initial and repeated training with ongoing feedback based on surveillance of clamp performance. The precision and accuracy of the achieved stage-specific glucose targets were evaluated, including differences by study center. We also evaluated robustness of the method to baseline physiologic differences and on-study treatment effects. The RISE approach produced high overall precision (3%-9% variance in achieved plasma glucose from target at various times across the procedure) and accuracy (SD < 10% overall). Statistically significant but numerically small differences in achieved target glucose concentrations were observed across study centers, within the magnitude of the observed technical variability. Variation of the achieved target glucose over time in placebo-treated individuals was low (<3% variation), and the method was robust to differences in baseline physiology (youth vs. adult, IGT vs. diabetes status) and differences in physiology induced by study treatments. The RISE approach to standardization of the hyperglycemic clamp methodology across multiple study centers produced technically excellent standardization of achieved glucose concentrations. This approach provides a reliable method for implementing glucose clamp methodology across multiple study centers. NEW & NOTEWORTHY  The Restoring Insulin Secretion (RISE) study centers undertook hyperglycemic clamps using a simplified methodology and a decision guidance algorithm implemented in an easy-to-use spreadsheet. This approach, combined with active management including ongoing central data surveillance and routine feedback to study centers, produced technically excellent standardization of achieved glucose concentrations on repeat studies within and across study centers.",2021,"Variation of the achieved target glucose over time in placebo-treated individuals was low (<3% variation), and the method was robust to differences in baseline physiology (youth vs adult, IGT vs diabetes status) and to differences in physiology induced by study treatments.
",['Two- stage hyperglycemic clamps with glucose targets of 200 mg/dL and'],[],"['Restoring Insulin Secretion (RISE', 'target glucose concentrations', 'overall precision']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]",[],"[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0717022,"Variation of the achieved target glucose over time in placebo-treated individuals was low (<3% variation), and the method was robust to differences in baseline physiology (youth vs adult, IGT vs diabetes status) and to differences in physiology induced by study treatments.
","[{'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Department of Medicine, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Ashley H', 'Initials': 'AH', 'LastName': 'Tjaden', 'Affiliation': 'The Biostatistics Center, Milken Institute School of Public Health, George Washington University, Washington, DC.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hoehn', 'Affiliation': 'College of Osteopathic Medicine, Marian University, Indianapolis, Indiana.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Colorado Denver, Colorado.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine, VA Puget Sound Health Care System, University of Washington, Seattle, Washington.'}, {'ForeName': 'Silva A', 'Initials': 'SA', 'LastName': 'Arslanian', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Department of Pediatrics, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Atkinson', 'Affiliation': 'Department of Medicine, VA Puget Sound Health Care System, University of Washington, Seattle, Washington.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cree-Green', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Colorado Denver, Colorado.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'Department of Medicine, VA Puget Sound Health Care System, University of Washington, Seattle, Washington.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'The Biostatistics Center, Milken Institute School of Public Health, George Washington University, Washington, DC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00598.2020']
559,33653635,Comparing an Imaging-guided Pathway with the Standard Pathway for Staging Muscle-invasive Bladder Cancer: Preliminary Data from the BladderPath Study.,"Transurethral resection of bladder tumour (TURBT) is central to the diagnosis of muscle-invasive bladder cancer (MIBC). With the oncological safety of TURBT unknown, staging inaccuracies commonplace, and correct treatment of MIBC potentially delayed, multiparametric magnetic resonance imaging (mpMRI) may offer rapid, accurate, and noninvasive diagnosis of MIBC. BladderPath is a randomised trial comparing risk-stratified (5-point Likert scale) image-directed care with TURBT for patients with newly diagnosed BC. To date, we have screened 279 patients and randomised 113. Here we report on the first 100 participants to complete staging: 48 in pathway 1 (TURBT) and 52 in pathway 2 (mpMRI for possible MIBC, Likert 3-5). Fifty of 52 participants designated Likert 1-2 (probable NMIBC) from both pathways were confirmed as having NMIBC (96%). Ten of 11 cases diagnosed as NMIBC by mpMRI have been pathologically confirmed as NMIBC, and 10/15 cases diagnosed as MIBC by mpMRI have been treated as MIBC (5 participants underwent TURBT). The specificity of mpMRI for identification of MIBC remains a limitation. These initial experiences indicate that it is feasible to direct possible MIBC patients to mpMRI for staging instead of TURBT. Furthermore, a 5-point Likert scale accurately identifies patients with low risk of MIBC (Likert 1-2), and flexible cystoscopy biopsies appear sufficient for diagnosing BC. PATIENT SUMMARY: We are conducting a clinical trial to assess whether some bladder tumour surgery can be replaced by magnetic resonance imaging scans to determine the stage of the cancer in patients whose tumours appear to be invasive. Our early data suggest that this approach is feasible. The data also show that using a visual score ('Likert scale') can help to identify bladder tumours that are very unlikely to be invasive, and that taking a biopsy in the outpatient clinic when first inspecting the bladder via a camera (diagnostic flexible cystoscopy) is useful for confirming bladder cancer.",2021,"The data also show that using a visual score ('Likert scale') can help to identify bladder tumours that are very unlikely to be invasive, and that taking a biopsy in the outpatient clinic when first inspecting the bladder via a camera (diagnostic flexible cystoscopy) is useful for confirming bladder cancer.","['patients with newly diagnosed BC', '279 patients and randomised 113', 'Staging Muscle-invasive Bladder Cancer', '100 participants to complete staging: 48 in pathway 1 (TURBT) and 52 in pathway 2 (mpMRI for possible MIBC, Likert 3-5']","['Transurethral resection of bladder tumour (TURBT', 'Imaging-guided Pathway with the Standard Pathway', 'BladderPath']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0442758', 'cui_str': '3/5'}]","[{'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],279.0,0.10181,"The data also show that using a visual score ('Likert scale') can help to identify bladder tumours that are very unlikely to be invasive, and that taking a biopsy in the outpatient clinic when first inspecting the bladder via a camera (diagnostic flexible cystoscopy) is useful for confirming bladder cancer.","[{'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Bryan', 'Affiliation': 'Bladder Cancer Research Centre, Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK; Action Bladder Cancer, UK.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Pirrie', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rashid', 'Initials': 'R', 'LastName': 'Amir', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': 'Patient Representative, UK.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Kieran P', 'Initials': 'KP', 'LastName': 'Jefferson', 'Affiliation': 'University Hospital Coventry & Warwickshire, Coventry, UK.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Knight', 'Affiliation': 'Patient Representative, UK; Action Bladder Cancer, UK.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Nanton', 'Affiliation': 'Warwick Medical School, University of Warwick, Warwick, UK.'}, {'ForeName': 'Harriet P', 'Initials': 'HP', 'LastName': 'Mintz', 'Affiliation': 'The Medical School, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Pope', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK; Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Bladder Cancer Research Centre, Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Institute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, London, UK. Electronic address: nick.james@icr.ac.uk.'}]",European urology,['10.1016/j.eururo.2021.02.021']
560,33657871,"Additional value of auricular intradermal acupuncture alongside selective serotonin reuptake inhibitors: a single-blinded, randomized, sham-controlled preliminary clinical study.","BACKGROUND


To evaluate the antidepressant effects of auricular intradermal acupuncture (AIA) of areas innervated by both the auricular branch of the vagus nerve and the trigeminal nerve.
METHODS


Forty-nine patients with depression were randomly allocated into an AIA group ( n  = 25) and a sham AIA group ( n  = 24). Both groups received selective serotonin reuptake inhibitors (SSRIs) as conventional treatment. The AIA group received AIA stimulation, and the sham AIA group received sham AIA, which constituted being subjected to an attached needle that did not penetrate the skin. The needles were retained for 4 h each session, with five sessions a week for a total duration of 2 weeks. The outcomes were assessed by the 17-item Hamilton depression rating scale (HAMD-17), five factors (sleep disorder, retardation, cognitive dysfunction, anxiety/somatization, and weight) and self-rating depression scale (SDS) at weeks 0, 1, and 2.
RESULTS


Fifty-four patients were randomly assigned to the AIA ( n  = 27) and sham AIA group ( n  = 27), of whom 25 patients in the AIA and 24 patients in the sham AIA group were analyzed. AIA-treated patients displayed a significantly greater reduction from baseline in HAMD-17 scores ( p  = 0.03) and SDS scores ( p  = 0.02) at week 2 compared to patients receiving sham AIA. The AIA intervention also produced a higher rate of clinically significant responses in sleep disorders ( p  = 0.07) compared to sham AIA. No adverse events occurred in either group.
CONCLUSION


According to the findings of this preliminary study, AIA appears to have additional value compared to SSRIs alone in treating patients with depressive disorder.",2021,The AIA intervention also produced a higher rate of clinically significant responses in sleep disorders ( p  = 0.07) compared to sham AIA.,"['Forty-nine patients with depression', 'patients with depressive disorder']","['auricular intradermal acupuncture (AIA', 'AIA stimulation, and the sham AIA group received sham AIA', 'auricular intradermal acupuncture alongside selective serotonin reuptake inhibitors', 'selective serotonin reuptake inhibitors (SSRIs']","['17-item Hamilton depression rating scale (HAMD-17), five factors (sleep disorder, retardation, cognitive dysfunction, anxiety/somatization, and weight) and self-rating depression scale (SDS', 'SDS scores', 'adverse events', 'sleep disorders', 'HAMD-17 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0025362', 'cui_str': 'Mental retardation'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",54.0,0.0528881,The AIA intervention also produced a higher rate of clinically significant responses in sleep disorders ( p  = 0.07) compared to sham AIA.,"[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Acupuncture and Medicine Research of Ministry of Education, The Second Clinical Medical School, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xiao-Ru', 'Initials': 'XR', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Acupuncture and Medicine Research of Ministry of Education, The Second Clinical Medical School, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xiao-Jing', 'Initials': 'XJ', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Acupuncture and Medicine Research of Ministry of Education, The Second Clinical Medical School, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Ti-Zhen', 'Initials': 'TZ', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Acupuncture and Medicine Research of Ministry of Education, The Second Clinical Medical School, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Miao', 'Affiliation': 'Key Laboratory of Acupuncture and Medicine Research of Ministry of Education, The Second Clinical Medical School, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Acupuncture and Medicine Research of Ministry of Education, The Second Clinical Medical School, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Hui-Fen', 'Initials': 'HF', 'LastName': 'Qiao', 'Affiliation': 'Department of Psychiatry, Nanjing Brain Hospital, Nanjing, China.'}, {'ForeName': 'Wing-Fai', 'Initials': 'WF', 'LastName': 'Yeung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Zhi-Ling', 'Initials': 'ZL', 'LastName': 'Sun', 'Affiliation': 'School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528421997155']
561,33655432,"The Effects of Zinc Sulfate Supplementation on Serum Copeptin, C-Reactive Protein and Metabolic Markers in Zinc-Deficient Diabetic Patients on Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Trial.","We aimed to investigate the association between zinc (Zn) supplementation and serum levels of copeptin, high-sensitive C-reactive protein (hs-CRP), glycemic control, anthropometric parameters and renal function in Zn -deficient diabetic hemodialysis patients (DHPs). This randomized, double-blind, placebo-controlled trial (RCT) was conducted on 46 DHPs with Zn-deficiency. The Zn supplement group (n = 21) received a 220-mg/day Zn sulfate capsule (containing 50 mg Zn), and the control group (n = 25) received a placebo capsule (220 mg corn starch), for 8 weeks. Fasting, predialysis blood samples were taken at baseline and after 8 weeks to assess fasting blood glucose (FBG), serum insulin, copeptin, high-sensitive C-reactive protein (hs-CRP), blood urea nitrogen (BUN), creatinine (Cr) concentrations, and homoeostatic model assessment (HOMA-IR) and quantitative insulin-sensitivity check index (QUICKI). Compared to controls, serum copeptin (P < 0.001), hs-CRP (P < 0.001), BUN (P < 0.001), Cr (P < 0.001), Zn (P < 0.001), FBG (P < 0.001) levels, BMI (P < 0.001), and body weight (P < 0.001) were significantly affected following ZnSO4 supplementation for 8 weeks. In contrast, QUICKI (P = 0.57), HOMA-IR (P = 0.60), and serum insulin (P = 0.55) were not affected following Zn supplementation in comparison with patients receiving placebo. Zn sulfate supplementation appears to have favorable effects on serum copeptin and hs-CRP, FBG, and renal function in Zn-deficient DHPs. Iranian Registry of Clinical Trials Identifier: IRCT20190806044461N1.",2022,"Compared to controls, serum copeptin (P < 0.001), hs-CRP (P < 0.001), BUN (P < 0.001), Cr (P < 0.001), Zn (P < 0.001), FBG (P < 0.001) levels, BMI (P < 0.001), and body weight (P < 0.001) were significantly affected following ZnSO4 supplementation for 8 weeks.","['46 DHPs with Zn-deficiency', 'Zinc-Deficient Diabetic Patients on Hemodialysis', 'Zn\xa0-deficient diabetic hemodialysis patients (DHPs']","['Zn sulfate supplementation', 'placebo', 'Zinc Sulfate Supplementation', 'placebo capsule (220 mg corn starch', 'Placebo', '220-mg/day Zn sulfate capsule (containing 50 mg Zn']","['HOMA-IR', 'body weight', 'serum copeptin', 'zinc (Zn) supplementation and serum levels of copeptin, high-sensitive C-reactive protein (hs-CRP), glycemic control, anthropometric parameters and renal function', 'Serum\xa0Copeptin, C-Reactive Protein and\xa0Metabolic Markers', 'hs-CRP', 'BUN', 'BMI', 'serum copeptin and hs-CRP, FBG, and renal function', 'fasting blood glucose (FBG), serum insulin, copeptin, high-sensitive C-reactive protein (hs-CRP), blood urea nitrogen (BUN), creatinine (Cr) concentrations, and homoeostatic model assessment (HOMA-IR) and quantitative insulin-sensitivity check index (QUICKI', 'serum insulin', 'FBG', 'Fasting, predialysis blood samples']","[{'cui': 'C0082226', 'cui_str': 'eIF-5A-deoxyhypusine synthase'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",46.0,0.359342,"Compared to controls, serum copeptin (P < 0.001), hs-CRP (P < 0.001), BUN (P < 0.001), Cr (P < 0.001), Zn (P < 0.001), FBG (P < 0.001) levels, BMI (P < 0.001), and body weight (P < 0.001) were significantly affected following ZnSO4 supplementation for 8 weeks.","[{'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Hosseini', 'Affiliation': 'Department of Nutrition, School of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Montazerifar', 'Affiliation': 'Pregnancy Health Research Center, Department of Nutrition, School of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran. fmontazerifar@gmail.com.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Shahraki', 'Affiliation': 'Genetics of Non-Communicable Disease Research Center, Department of Nephrology, School of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Karajibani', 'Affiliation': 'Health Promotion Research Center , Department of Nutrition, School of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Ali Mohammad', 'Initials': 'AM', 'LastName': 'Mokhtari', 'Affiliation': 'School of Health, Gonabad University of Medical Sciences, Gonabad, Khorasan Razavi, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Dashipour', 'Affiliation': 'Cellular and Molecular Research Center, Department of Food and Technology, School of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Ferns', 'Affiliation': 'Brighton & Sussex Medical School, Division of Medical Education, Falmer, Brighton, Sussex, UK.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Jalali', 'Affiliation': 'Nutrition Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Biological trace element research,['10.1007/s12011-021-02649-7']
562,33648350,Efficacy and safety of modafinil versus dexamethasone in cancer-related fatigue: a prospective randomized controlled study.,"The aim of this study was to compare the efficacy and safety of modafinil and dexamethasone in the management of cancer-related fatigue and their effects on quality of life (QoL). A prospective randomized controlled study was conducted, enrolling 80 cancer patients experiencing moderate or severe fatigue following at least three cycles of chemotherapy or a course of palliative/curative radiotherapy. Patients received either oral modafinil 100 mg or dexamethasone 4 mg daily for 14 days. Levels of fatigue, QoL and symptom severity were compared after 14-21 days. Both drugs were efficacious and safe in the management of fatigue and QoL. However, modafinil performed marginally better. Although modafinil demonstrated marginal superiority, both modafinil and dexamethasone can improve fatigue and QoL in cancer patients. Clinical trials registry of India: CTRI/2018/05/014046 (www.ctri.nic.in).",2021,"Although modafinil demonstrated marginal superiority, both modafinil and dexamethasone can improve fatigue and QoL in cancer patients.","['cancer patients', 'enrolling 80 cancer patients experiencing moderate or severe fatigue following at least three cycles of chemotherapy or a course of palliative/curative radiotherapy', 'cancer-related fatigue']","['modafinil and dexamethasone', 'oral modafinil 100\xa0mg or dexamethasone', 'modafinil', 'modafinil versus dexamethasone']","['fatigue and QoL', 'Efficacy and safety', 'efficacy and safety', 'Levels of fatigue, QoL and symptom severity', 'quality of life (QoL']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0987899', 'cui_str': 'modafinil 100 MG'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",80.0,0.0904192,"Although modafinil demonstrated marginal superiority, both modafinil and dexamethasone can improve fatigue and QoL in cancer patients.","[{'ForeName': 'Uttiya', 'Initials': 'U', 'LastName': 'Deb', 'Affiliation': 'Pharmacology, Burdwan Medical College, Burdwan, 713104, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Pharmacology, Burdwan Medical College, Burdwan, 713104, India.'}, {'ForeName': 'Biswamit', 'Initials': 'B', 'LastName': 'Bhattacharya', 'Affiliation': 'Radiation Oncology, Burdwan Medical College, Burdwan,\xa0713104, India.'}, {'ForeName': 'Sanatan', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Radiation Oncology, Burdwan Medical College, Burdwan,\xa0713104, India.'}, {'ForeName': 'Supreeti', 'Initials': 'S', 'LastName': 'Biswas', 'Affiliation': 'Pharmacology, Burdwan Medical College, Burdwan, 713104, India.'}]","Future oncology (London, England)",['10.2217/fon-2020-0853']
563,33666270,Probiotics ameliorates glycemic control of patients with diabetic nephropathy: A randomized clinical study.,"OBJECTIVE


This research aimed to explore the effects of probiotic administration on glycemic control and renal function in patients with diabetic nephropathy (DN).
METHODS


The 101 participants were randomly divided into two treatment groups and 76 patients were included in the final analysis. In 76 patients with diabetic nephropathy of type 2 diabetes, a randomized double-blind and placebo-controlled clinical trial was conducted to evaluate the administration of 3.2 × 10 9   CFU probiotic supplements per day (Bifidobacterium bifidum, 1.2 × 10 9   CFU, Lactobacillus acidophilus 4.2 × 10 9   CFU, Streptococcus thermophilus 4.3 × 10 9   CFU) for 12 weeks on glycemic control of patients, including fasting blood glucose, 2 h postprandial blood glucose, glycosylated hemoglobin (HbA1c), microalbuminuria/creatinine (mAlb/Cr) and estimated glomerular filtration rate (eGFR) levels. The placebo group daily received empty capsules filled with starch.
RESULTS


After 12 weeks, the administration of probiotics demonstrated a significant reduction in fasting blood glucose (10.68 ± 3.24 mmol/L before vs. 7.81 ± 2.77 mmol/L after, p < 0.05), HbA1c (8.19 ± 1.60% before vs. 7.32 ± 1.20% after, p < 0.05) and mAlb/Cr (101.60 ± 22.17 mg/g before vs. 67.53 ± 20.11 mg/g after, p < 0.05), while only mAlb/Cr level was significantly lower in the probiotic group than in the placebo group after intervention (67.53 ± 20.11 mg/g vs. 87.71 ± 23.01, p < 0.05). Meanwhile, there was no significant reduction of 2 h postprandial blood glucose level (18.95 ± 5.23 mmol/L vs. 17.35 ± 6.28 mmol/L, p = 0.24) and eGFR (84.34 ± 6.97 ml/min vs. 82.8 ± 8.72 ml/min, p = 0.45) in patients before and after probiotic intake. In addition, the placebo group failed to show any significant change of these parameters.
CONCLUSION


This clinical study revealed probiotic administration could ameliorate glycemic control of patients with diabetic nephropathy, potentiating its therapeutic potential in clinical application.",2021,"After 12 weeks, the administration of probiotics demonstrated a significant reduction in fasting blood glucose (10.68 ± 3.24 mmol/L before vs. 7.81 ± 2.77 mmol/L after, p < 0.05), HbA1c (8.19 ± 1.60% before vs. 7.32 ± 1.20% after, p < 0.05) and mAlb/Cr (101.60 ± 22.17 mg/g before vs. 67.53 ± ","['101 participants were randomly divided into two treatment groups and 76 patients were included in the final analysis', '76 patients with diabetic nephropathy of type 2 diabetes', 'patients with diabetic nephropathy (DN', 'patients with diabetic nephropathy']","['placebo', 'empty capsules filled with starch', 'CFU probiotic supplements per day (Bifidobacterium bifidum, 1.2\xa0×\xa010 9  \xa0CFU, Lactobacillus acidophilus 4.2', 'probiotic administration', 'Probiotics']","['fasting blood glucose', 'glycemic control and renal function', '2\xa0h postprandial blood glucose level', 'mAlb/Cr level', 'fasting blood glucose, 2\xa0h postprandial blood glucose, glycosylated hemoglobin (HbA1c),\xa0microalbuminuria/creatinine (mAlb/Cr) and estimated glomerular filtration rate (eGFR) levels']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",101.0,0.0671555,"After 12 weeks, the administration of probiotics demonstrated a significant reduction in fasting blood glucose (10.68 ± 3.24 mmol/L before vs. 7.81 ± 2.77 mmol/L after, p < 0.05), HbA1c (8.19 ± 1.60% before vs. 7.32 ± 1.20% after, p < 0.05) and mAlb/Cr (101.60 ± 22.17 mg/g before vs. 67.53 ± ","[{'ForeName': 'Hongyang', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'China-Japan Union Hospital Affiliated Jilin University, Changchun, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'China-Japan Union Hospital Affiliated Jilin University, Changchun, China.'}, {'ForeName': 'Dongyan', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'China-Japan Union Hospital Affiliated Jilin University, Changchun, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'China-Japan Union Hospital Affiliated Jilin University, Changchun, China.'}]",Journal of clinical laboratory analysis,['10.1002/jcla.23650']
564,33647189,"Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan.","To evaluate the pharmacokinetic interactions among rosuvastatin, ezetimibe, and telmisartan, a randomized, open-label, 3-period, 6-sequence crossover study was conducted in healthy subjects. Subjects received one of the following treatments once daily for 7 days in each period with a 1-week washout: a fixed-dose combination of ezetimibe/rosuvastatin 10/20 mg, telmisartan 80 mg, combination therapy of ezetimibe/rosuvastatin 10/20 mg, or telmisartan 80 mg. Blood samples were collected up to 24 hours postdose at steady state. Geometric mean ratios (GMRs) and their 90% confidence intervals (CIs) of the combination therapy to monotherapy for the maximum plasma concentration (C max,ss  ), and the area under the time-concentration curve within a dosing interval at steady state (AUC tau,ss  ) were estimated. Among the 36 randomized subjects, 31 subjects completed the study. The GMRs and 90%CIs of C max,ss  and AUC tau,ss  of total ezetimibe were not significantly altered. The C max,ss  of free ezetimibe was increased (GMR, 1.85; 90%CI, 1.56-2.19) but not for the AUC tau,ss  (GMR, 1.16; 90%CI, 1.06-1.26). Similarly, the C max,ss  of rosuvastatin was increased (GMR, 2.13; 90%CI, 1.88-2.43) without a change in the AUC tau,ss  (GMR, 1.09; 90%CI, 1.03-1.15). The C max,ss  (GMR, 1.16; 90%CI, 1.01-1.32) and AUC tau,ss  (GMR, 1.26; 90%CI, 1.17-1.37) of telmisartan were slightly increased. Considering the therapeutic range of the components, the interaction would have limited clinical impact.",2021,"The C max,ss  of free ezetimibe was increased (GMR, 1.85;","['36 randomized subjects, 31 subjects completed the study', 'healthy subjects']","['Ezetimibe, Rosuvastatin, and Telmisartan', 'ezetimibe/rosuvastatin 10/20 mg, telmisartan 80 mg, combination therapy of ezetimibe/rosuvastatin 10/20 mg, or telmisartan', 'rosuvastatin, ezetimibe, and telmisartan']","['C max,ss  of rosuvastatin', 'Geometric mean ratios (GMRs', 'GMRs and 90%CIs of C max,ss  and AUC tau,ss  of total ezetimibe', 'maximum plasma concentration (C max,ss  ), and the area under the time-concentration curve', 'C max,ss  of free ezetimibe', 'Blood samples']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0990503', 'cui_str': 'telmisartan 80 MG'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",36.0,0.0156142,"The C max,ss  of free ezetimibe was increased (GMR, 1.85;","[{'ForeName': 'Ki Young', 'Initials': 'KY', 'LastName': 'Huh', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Won', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Hanyang University Seoul Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Si Beum', 'Initials': 'SB', 'LastName': 'Lee', 'Affiliation': 'Addpharma Inc., Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Kyung Tae', 'Initials': 'KT', 'LastName': 'Kim', 'Affiliation': 'Addpharma Inc., Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.926']
565,33657762,Effect of neurogenic acupoint cupping on high sensitive C-reactive protein and pain perception in female chronic pelvic pain: A randomized controlled trial.,"OBJECTIVES


To determine the effect of neurogenic acupoint dry cupping therapy on high sensitive C-reactive protein (hs-CRP) level, pain perception & intensity, and life impact of pelvic pain in women with chronic pelvic pain (CPP), with regard to the biological and neurophysiological impacts of dry cupping on acupoint.
METHODS


Thirty women with CPP were randomly divided into two equal groups; the study group received dry cupping on neurogenic acupoints plus lifestyle modifications for 8 weeks (n=15), while the control group received only lifestyle modifications for 8 weeks (n=15). Women were assessed pre- and post-rehabilitation program with the hs-CRP blood test, the short-form McGill Pain Questionnaire (SF-MPQ), and the pelvic pain impact questionnaire (PPIQ).
RESULTS


Comparing both groups post-treatment revealed that there were significant reductions in levels of hs-CRP, and scores of SF-MPQ & PPIQ (p<0.05) in the study group compared with the control group. Also, there were significant positive correlations between hs-CRP and both SF-MPQ ""Visual Analogue Scale (VAS), Present Pain Intensity (PPI) index & Pain Rating Index (PRI)"" and PPIQ (p<0.05).
CONCLUSION


Neurogenic acupoint cupping therapy had significantly improving effects on the degree of inflammation, pain perception & intensity, and life impact of pelvic pain in women with CPP.",2021,"Comparing both groups post-treatment revealed that there were significant reductions in levels of hs-CRP, and scores of SF-MPQ & PPIQ (p<0.05) in the study group compared with the control group.","['female chronic pelvic pain', 'women with CPP', 'women with chronic pelvic pain (CPP', 'Thirty women with CPP']","['neurogenic acupoint dry cupping therapy', 'Neurogenic acupoint cupping therapy', 'dry cupping on neurogenic acupoints plus lifestyle modifications', 'control group received only lifestyle modifications', 'neurogenic acupoint cupping']","['SF-MPQ ""Visual Analogue Scale (VAS), Present Pain Intensity (PPI) index & Pain Rating Index (PRI)"" and PPIQ (p<0.05', 'degree of inflammation, pain perception & intensity, and life impact of pelvic pain', 'levels of hs-CRP, and scores of SF-MPQ & PPIQ', 'high sensitive C-reactive protein (hs-CRP) level, pain perception & intensity, and life impact of pelvic pain', 'McGill Pain Questionnaire (SF-MPQ), and the pelvic pain impact questionnaire (PPIQ']","[{'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C5197695', 'cui_str': 'Cupping Treatment'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",30.0,0.0509402,"Comparing both groups post-treatment revealed that there were significant reductions in levels of hs-CRP, and scores of SF-MPQ & PPIQ (p<0.05) in the study group compared with the control group.","[{'ForeName': 'Khadiga S', 'Initials': 'KS', 'LastName': 'Abdulaziz', 'Affiliation': ""Department of Physical Therapy For Woman's Health, Faculty of Physical Therapy, Cairo University, Egypt.""}, {'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Tareq Mohamad', 'Affiliation': 'Department of Physiotherapy, Family Medicine Unit, Health Affairs Directorate - 6th Of October (Ministry of health), Giza, Egypt.'}, {'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Saad El-Din Mahmoud', 'Affiliation': 'Department of Physical Therapy For Neuromuscular Disorders and its surgery, Faculty of Physical Therapy, October 6 University, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Abdel Azim Ramzy', 'Affiliation': 'Department of Clinical and Chemical Pathology, Faculty of medicine, Cairo University, Egypt.'}, {'ForeName': 'Doaa A', 'Initials': 'DA', 'LastName': 'Osman', 'Affiliation': ""Department of Physical Therapy For Woman's Health, Faculty of Physical Therapy, Cairo University, Egypt.""}]",Journal of musculoskeletal & neuronal interactions,[]
566,33657760,Multimodal analgesia protocol for pain management after total knee arthroplasty: comparison of three different regional analgesic techniques.,"OBJECTIVES


To evaluate three different analgesic techniques, continuous epidural analgesia (EA), continuous intra-articular (IA) infusion analgesia and continuous femoral nerve block (FNB) in postoperative pain management, length of hospital stay (LOS), and time of patient mobilization after total knee arthroplasty (TKA).
METHODS


Seventy-two patients undergoing TKA were randomly allocated into three groups according to the analgesic technique used for postoperative pain management. Group EA patients received epidural analgesia (control group), group IA received intra-articular infusion and group FNB received femoral nerve block.
RESULTS


Upon analyzing the Numerical Rating Scale (NRS) scores at rest, at passive and active movement, up to 3 days postoperatively, we observed no statistically significant differences at any time point among the three groups. Similarly, no association among these analgesic techniques (EA, IA, FNB) was revealed regarding LOS. However, significant differences emerged concerning the time of mobilization. Patients who received IA achieved earlier mobilization compared to FNB and EA.
CONCLUSIONS


Both IA and FNB generate similar analgesic effect with EA for postoperative pain management after TKA. However, IA appears to be significantly more effective in early mobilization compared to EA and FNB. Finally, no clinically important differences could be detected regarding LOS among the techniques studied.",2021,"up to 3 days postoperatively, we observed no statistically significant differences at any time point among the three groups.","['pain management after total knee arthroplasty', 'Seventy-two patients undergoing TKA']","['continuous epidural analgesia (EA), continuous intra-articular (IA) infusion analgesia and continuous femoral nerve block (FNB', 'epidural analgesia (control group), group IA received intra-articular infusion and group FNB received femoral nerve block', 'Multimodal analgesia protocol', 'analgesic technique used for postoperative pain management']","['analgesic techniques (EA, IA, FNB', 'Numerical Rating Scale (NRS) scores', 'time of mobilization', 'postoperative pain management, length of hospital stay (LOS), and time of patient mobilization after total knee arthroplasty (TKA']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0412784', 'cui_str': 'Analgesic technique'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",72.0,0.0639441,"up to 3 days postoperatively, we observed no statistically significant differences at any time point among the three groups.","[{'ForeName': 'Georgios Z', 'Initials': 'GZ', 'LastName': 'Karpetas', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Maria K', 'Initials': 'MK', 'LastName': 'Spyraki', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Savvas I', 'Initials': 'SI', 'LastName': 'Giakoumakis', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Fotini G', 'Initials': 'FG', 'LastName': 'Fligou', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Panagiotis D', 'Initials': 'PD', 'LastName': 'Megas', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Gregorios S', 'Initials': 'GS', 'LastName': 'Voyagis', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Elias C', 'Initials': 'EC', 'LastName': 'Panagiotopoulos', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Patras, Patras, Greece.'}]",Journal of musculoskeletal & neuronal interactions,[]
567,33657757,Suit therapy versus whole-body vibration on bone mineral density in children with spastic diplegia.,"OBJECTIVES


Osteoporosis because of physical inactivity is one of the major complications associated with neuromuscular disorders. The study aimed to compare using Suit therapy and whole-body vibration in addition to selected physical therapy program to improve Bone Mineral Density in children with cerebral palsy of spastic diplegia.
METHODS


Forty-six patients were classified randomly into two equal groups. Patients in the group (A) engaged in a selected physical therapy program, also besides, suit therapy training program while those in the group (B) received the same selected physical therapy program received by group (A) in addition to the whole-body vibration training program. The treatment programs were conducted three times per week for twelve successive weeks. Measurements obtained included bone mineral density at the lumbar spine as well as at the femoral neck. These measures were recorded pre- and post-treatment.
RESULTS


There was a significant improvement in favor of the whole-body Vibration group. Bone mineral density improved significantly at both the lumbar spine (P=.038) and the femoral neck (P=.005) in the WBV group as compared to the Suit therapy group.
CONCLUSIONS


Whole-body vibration is effective in improving Bone Mineral Density rather than Suit therapy in children with cerebral palsy of spastic diplegia.",2021,"Bone mineral density improved significantly at both the lumbar spine (P=.038) and the femoral neck (P=.005) in the WBV group as compared to the Suit therapy group.
","['children with cerebral palsy of spastic diplegia', 'Forty-six patients', 'children with spastic diplegia']","['Suit therapy and whole-body vibration in addition to selected physical therapy program', 'Suit therapy versus whole-body vibration', 'selected physical therapy program, also besides, suit therapy training program while those in the group (B) received the same selected physical therapy program received by group (A) in addition to the whole-body vibration training program']","['Bone mineral density', 'bone mineral density', 'femoral neck', 'Bone Mineral Density']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]",46.0,0.00961162,"Bone mineral density improved significantly at both the lumbar spine (P=.038) and the femoral neck (P=.005) in the WBV group as compared to the Suit therapy group.
","[{'ForeName': 'Amira E', 'Initials': 'AE', 'LastName': 'El-Bagalaty', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Egypt.'}, {'ForeName': 'Marwa M I', 'Initials': 'MMI', 'LastName': 'Ismaeel', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Egypt.'}]",Journal of musculoskeletal & neuronal interactions,[]
568,33657755,The effects of whole-body vibration on EMG activity of the lower body muscles in supine static bridge position.,"OBJECTIVES


The purpose of the current study was to firstly examine the effects of different whole-body vibration (WBV) frequencies in the lower-body muscles when applied simultaneously during a bridge exercise. Secondly, determine if there were any sex differences in the lower-body muscles of WBV during the bridge.
METHODS


Seven females and 7 males completed 2 familiarization and 1 test sessions. In the test session participants were randomized to complete one 30 s bout of a bridge exercise for 3 separate conditions followed by 3-min of rest. The 3 conditions (a) No-WBV (without WBV); (b) WBV-30 (30 Hz, low amplitude); (c) WBV-50 (50 Hz, low amplitude) were performed on a WBV platform. Muscle activity of the biceps femoris (BF), semitendinosus (ST), gluteus maximus (Gmax), multifidus muscle (MF) muscles were measured.
RESULTS


Muscle activity was increased with WBV in the BF and ST muscles at WBV-30 and WBV-50 conditions (p<0.05) vs. no-WBV. During No-WBV and WBV-50 conditions, males had a higher biceps femoris activity compared to females for (p<0.05) 45 and 27 %, respectively; however, during all conditions females had a high level of Gmax activity (57%) than males (p<0.05).
CONCLUSION


Additional vibration at 30 and 50 Hz during the bridge exercise could be a useful method to enhance hamstring muscle activity.",2021,"During No-WBV and WBV-50 conditions, males had a higher biceps femoris activity compared to females for (p<0.05) 45 and 27 %, respectively; however, during all conditions females had a high level of Gmax activity (57%) than males (p<0.05).
","['supine static bridge position', 'Seven females and 7 males completed 2 familiarization and 1 test sessions']","['bridge exercise', 'whole-body vibration']","['high level of Gmax activity', 'WBV (without WBV); (b) WBV-30', 'hamstring muscle activity', 'Muscle activity', 'Muscle activity of the biceps femoris (BF), semitendinosus (ST), gluteus maximus (Gmax), multifidus muscle (MF) muscles', 'biceps femoris activity']","[{'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0444378', 'cui_str': 'Bridging position'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0454350', 'cui_str': 'Bridging exercise'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}]",,0.0168473,"During No-WBV and WBV-50 conditions, males had a higher biceps femoris activity compared to females for (p<0.05) 45 and 27 %, respectively; however, during all conditions females had a high level of Gmax activity (57%) than males (p<0.05).
","[{'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Marín', 'Affiliation': 'CYMO Research Institute, Valladolid, Spain.'}, {'ForeName': 'Darryl J', 'Initials': 'DJ', 'LastName': 'Cochrane', 'Affiliation': 'School of Sport, Exercise & Nutrition, Massey University, New Zealand.'}]",Journal of musculoskeletal & neuronal interactions,[]
569,33657754,"Cross training effects of non-paralytic dorsiflexion muscle strengthening exercise on paralytic dorsiflexor muscle activity, gait ability, and balancing ability in patients with chronic stroke: A randomized, controlled, pilot trial.","OBJECTIVE


To investigate the effects of non-paralytic dorsiflexion muscle strengthening exercise on functional abilities in chronic hemiplegic patients after stroke.
METHODS


A total of 21 patients with chronic stroke underwent dorsiflexion muscle strengthening exercise (MST) 5 times a week for 6 weeks (the experimental group, MST to non-paralytic dorsiflexion muscles, n=11; the control group, MST to paralytic dorsiflexion muscles; n=10). Paralytic dorsiflexor muscle activities (DFA) and 10 m walking tests (10MWT) and timed up and go tests (TUG) were measured before and after intervention.
RESULTS


A significant increase in DFA was observed after intervention in the experimental and control groups (p<0.05) (experimental 886.6% for reference voluntary contraction (RVC), control 931.6% for RVC). TUG and 10MWT results showed significant reductions post-intervention in the experimental and control groups (experimental group -5.6 sec, control -4.8 sec; experimental group -3.1 sec, control, -3.9 sec; respectively). No significant intergroup difference was observed between changes in DFA or between changes in TUG and 10MWT results after intervention (p>.05).
CONCLUSION


Strengthening exercise performed on non-paralytic dorsiflexion muscles had positive cross-training effects on paralytic dorsiflexor muscle activities, balance abilities, and walking abilities in patients with chronic stroke.",2021,"No significant intergroup difference was observed between changes in DFA or between changes in TUG and 10MWT results after intervention (p>.05).
","['patients with chronic stroke', 'chronic hemiplegic patients after stroke', '21 patients with chronic stroke']","['Strengthening exercise', 'non-paralytic dorsiflexion muscle strengthening exercise', 'dorsiflexion muscle strengthening exercise (MST']","['paralytic dorsiflexor muscle activities, balance abilities, and walking abilities', 'functional abilities', 'Paralytic dorsiflexor muscle activities (DFA) and 10 m walking tests (10MWT) and timed up and go tests (TUG', 'paralytic dorsiflexor muscle activity, gait ability, and balancing ability', 'DFA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",21.0,0.0144399,"No significant intergroup difference was observed between changes in DFA or between changes in TUG and 10MWT results after intervention (p>.05).
","[{'ForeName': 'Sung-Chan', 'Initials': 'SC', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea.'}, {'ForeName': 'Jun-Nam', 'Initials': 'JN', 'LastName': 'Ryu', 'Affiliation': 'Department of Physical Therapy, Yeoju University, Republic of Korea.'}, {'ForeName': 'Se-Jung', 'Initials': 'SJ', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea.'}]",Journal of musculoskeletal & neuronal interactions,[]
570,33656484,Change in Learning and Memory Partially Mediates Effects of Compensatory Cognitive Training on Self-Reported Cognitive Symptoms.,"OBJECTIVE


To examine associations among compensatory cognitive training (CCT), objective cognitive functioning, and self-reported cognitive symptoms. We examined whether change in objective cognitive functioning associated with participation in CCT at 10-week follow-up mediates change in self-reported cognitive symptoms associated with CCT at 15-week follow-up.
SETTING


Three VA outpatient mental health clinics.
PARTICIPANTS


Veterans with a history of mild traumatic brain injury who reported cognitive deficits.
DESIGN


Randomized controlled trial post hoc causal mediation analysis.
MAIN MEASURES


Self-reported cognitive symptoms were measured by the Prospective-Retrospective Memory Questionnaire and the Multiple Sclerosis Neuropsychological Screening Questionnaire. Objective cognitive functioning was measured using a battery of neuropsychological tests.
RESULTS


Improvement on the Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall test mediated the association between participation in CCT and decrease in the Prospective-Retrospective Memory Questionnaire total score. Improvement on the HVLT-R Total Recall and HVLT-R Delayed Recall tests both meditated the association between participation in CCT and decrease in the Multiple Sclerosis Neuropsychological Screening Questionnaire total score. No other measures of objective cognitive functioning were significant mediators.
CONCLUSION


Patients' perceptions of cognitive symptom improvement due to CCT are partially mediated by learning and memory, though these subjective improvements occur regardless of other changes in objective cognitive functioning associated with CCT.",2021,Improvement on the HVLT-R Total Recall and HVLT-R Delayed Recall tests both meditated the association between participation in CCT and decrease in the Multiple Sclerosis Neuropsychological Screening Questionnaire total score.,"['Three VA outpatient mental health clinics', 'Veterans with a history of mild traumatic brain injury who reported cognitive deficits']","['compensatory cognitive training (CCT', 'Compensatory Cognitive Training']","['Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall test', 'Self-reported cognitive symptoms', 'Multiple Sclerosis Neuropsychological Screening Questionnaire total score', 'Prospective-Retrospective Memory Questionnaire total score', 'Objective cognitive functioning', 'objective cognitive functioning', 'HVLT-R Total Recall and HVLT-R Delayed Recall tests']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0273163,Improvement on the HVLT-R Total Recall and HVLT-R Delayed Recall tests both meditated the association between participation in CCT and decrease in the Multiple Sclerosis Neuropsychological Screening Questionnaire total score.,"[{'ForeName': 'Maya Elin', 'Initials': 'ME', 'LastName': ""O'Neil"", 'Affiliation': ""VA Portland Health Care System, Portland, Oregon (Drs O'Neil, Roost, Storzbach, and Huckans, Mr Cameron, and Mss Shirley and Sano); Departments of Psychiatry (Drs O'Neil, Storzbach, and Huckans), Medical Informatics and Clinical Epidemiology (Dr O'Neil), and Neurology (Dr Storzbach), Oregon Health & Science University, Portland; Center of Excellence for Stress and Mental Health, VA San Diego Healthcare System, San Diego, California (Drs Twamley and Jak); Department of Psychiatry, University of California San Diego, La Jolla (Drs Twamley and Jak); VA Puget Sound Health Care System, Seattle, Washington (Drs Williams, Turner, and Pagulayan); and Departments of Rehabilitation Medicine (Drs Williams and Turner) and Psychiatry and Behavioral Sciences (Dr Pagulayan), University of Washington School of Medicine, Seattle.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Shirley', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sano', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Twamley', 'Affiliation': ''}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Pagulayan', 'Affiliation': ''}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Roost', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Jak', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Storzbach', 'Affiliation': ''}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Huckans', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000662']
571,33658092,Light therapy for seasonal affective disorder in visual impairment and blindness - a pilot study.,"OBJECTIVE


Seasonal and non-seasonal depression are prevalent conditions in visual impairment (VI). We assessed the effects and side effects of light therapy in persons with severe VI/blindness who experienced recurrent depressive symptoms in winter corresponding to seasonal affective disorder (SAD) or subsyndromal SAD (sSAD).
RESULTS


We included 18 persons (11 with severe VI, 3 with light perception and 4 with no light perception) who met screening criteria for sSAD/SAD in a single-arm, assessor-blinded trial of 6 weeks light therapy. In the 12 persons who completed the 6 weeks of treatment, the post-treatment depression score was reduced (p < 0.001), and subjective wellbeing (p = 0.01) and sleep quality were improved (p = 0.03). In 6/12 participants (50%), the post-treatment depression score was below the cut-off set for remission. In four participants with VI, side effects (glare or transiently altered visual function) led to dropout or exclusion.
CONCLUSION


Light therapy was associated with a reduction in depressive symptoms in persons with severe VI/blindness. Eye safety remains a concern in persons with residual sight.",2021,"In the 12 persons who completed the 6 weeks of treatment, the post-treatment depression score was reduced (p < 0.001), and subjective wellbeing (p = 0.01) and sleep quality were improved (p = 0.03).","['persons with residual sight', 'persons with severe visual impairment/blindness', '18 persons (11 with severe visual impairment, 3 with light perception, 4 with no light perception) who met screening criteria for sSAD/SAD in a single-arm, assessor-blinded trial of 6 weeks light therapy', 'persons with severe visual impairment/blindness who had recurrent depressive symptoms in winter corresponding to seasonal affective disorder (SAD) or subsyndromal SAD (sSAD', '4 participants with visual impairment, side effects (glare or transiently altered visual function) led to drop-out or exclusion']","['light therapy', 'Light therapy']","['sleep quality', 'depressive symptoms', 'subjective wellbeing', 'post-treatment depression score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1301509', 'cui_str': 'Severe visual impairment'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0442774', 'cui_str': 'Visual acuity, no light perception'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0278215', 'cui_str': 'Glare'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",4.0,0.148923,"In the 12 persons who completed the 6 weeks of treatment, the post-treatment depression score was reduced (p < 0.001), and subjective wellbeing (p = 0.01) and sleep quality were improved (p = 0.03).","[{'ForeName': 'Helle Østergaard', 'Initials': 'HØ', 'LastName': 'Madsen', 'Affiliation': 'Mental Health Centre Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Shakoor', 'Initials': 'S', 'LastName': 'Ba-Ali', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Hageman', 'Affiliation': 'Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Lund-Andersen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Martiny', 'Affiliation': 'Mental Health Centre Copenhagen, Copenhagen, Denmark.'}]",Acta neuropsychiatrica,['10.1017/neu.2021.6']
572,33665769,Serum Biomarkers of Regeneration and Plasticity are Associated with Functional Outcome in Pediatric Neurocritical Illness: An Exploratory Study.,"BACKGROUND/OBJECTIVE


Pediatric neurocritical care survivorship is frequently accompanied by functional impairments. Lack of prognostic biomarkers is a barrier to early identification and management of impairment. We explored the association between blood biomarkers and functional impairment in children with acute acquired brain injury.
METHODS


This study is a secondary analysis of a randomized control trial evaluating early versus usual care rehabilitation in the pediatric intensive care unit (PICU). Forty-four children (17 [39%] female, median age 11 [interquartile range 6-13] years) with acute acquired brain injury admitted to the PICU were studied. A single center obtained serum samples on admission days 0, 1, 3, 5, and the day closest to hospital discharge. Biomarkers relevant to brain injury (neuron specific enolase [NSE], S100b), inflammation (interleukin [IL-6], C-reactive protein), and regeneration (brain-derived neurotrophic factor [BDNF], vascular endothelial growth factor [VEGF]) were collected. Biomarkers were analyzed using a Luminex® bioassay. Functional status scale (FSS) scores were abstracted from the medical record. New functional impairment was defined as a (worse) FSS score at hospital discharge compared to pre-PICU (baseline). Individual biomarker fluorescence index (FI) values for each sample collection day were correlated with new functional impairment using Spearman rank correlation coefficient (ρ). Trends in repeated measures of biomarker FI over time were explored graphically, and the association between repeated measures of biomarker FI and new functional impairment was analyzed using covariate adjusted linear mixed-effect models.
RESULTS


Functional impairment was inversely correlated with markers of regeneration and plasticity including BDNF at day 3 (ρ =  - 0.404, p = .015), day 5 (ρ =  - 0.549, p = 0.005) and hospital discharge (ρ =  - 0.420, p = 0.026) and VEGF at day 1 (ρ =  - 0.282, p = 0.008) and hospital discharge (ρ =  - 0.378, p = 0.047), such that lower levels of both markers at each time point were associated with greater impairment. Similarly, repeated measures of BDNF and VEGF were inversely correlated with new functional impairment (B =  - 0.001, p = 0.001 and B =  - 0.001, p = 0.003, respectively). NSE, a biomarker of acute brain injury, showed a positive correlation between day 0 levels and new functional impairment (ρ = 0.320, p = 0.044).
CONCLUSIONS


Blood-based biomarkers of regeneration and plasticity may hold prognostic utility for functional impairment among pediatric patients with neurocritical illness and warrant further investigation.",2021,"Similarly, repeated measures of BDNF and VEGF were inversely correlated with new functional impairment (B =  - 0.001, p = 0.001 and B =  - 0.001, p = 0.003, respectively).","['children with acute acquired brain injury', 'Forty-four children (17 [39%] female, median age 11 [interquartile range 6-13] years) with acute acquired brain injury admitted to the PICU were studied', 'Pediatric Neurocritical Illness', 'pediatric intensive care unit (PICU', 'pediatric patients with neurocritical illness']",['usual care rehabilitation'],"['hospital discharge', 'Functional status scale (FSS) scores', 'VEGF', 'BDNF and VEGF', 'brain injury (neuron specific enolase [NSE], S100b), inflammation (interleukin [IL-6], C-reactive protein), and regeneration (brain-derived neurotrophic factor [BDNF], vascular endothelial growth factor [VEGF', 'new functional impairment', 'biomarker FI and new functional impairment', 'Individual biomarker fluorescence index (FI) values', 'markers of regeneration and plasticity including BDNF']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",44.0,0.0464905,"Similarly, repeated measures of BDNF and VEGF were inversely correlated with new functional impairment (B =  - 0.001, p = 0.001 and B =  - 0.001, p = 0.003, respectively).","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Madurski', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Jarvis', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Sue R', 'Initials': 'SR', 'LastName': 'Beers', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Houtrow', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Wagner', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fabio', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Smith', 'Affiliation': ""Division of Critical Care, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Doughty', 'Affiliation': ""Division of Critical Care Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Janesko-Feldman', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rubin', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Pollon', 'Affiliation': 'Special Needs Child Advocate and Study Stakeholder, Pittsburgh, PA, USA.'}, {'ForeName': 'Amery', 'Initials': 'A', 'LastName': 'Treble-Barna', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Kochanek', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Ericka L', 'Initials': 'EL', 'LastName': 'Fink', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA. finkel@ccm.upmc.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurocritical care,['10.1007/s12028-021-01199-z']
573,33661694,A secondary analysis of a brief video intervention on suicidal ideation among recent rape victims.,"Although rape has been linked to risk for suicidal ideation and attempts, there are scant data on the efficacy of brief interventions to reduce suicidality among recent rape victims. This secondary analysis of a randomized controlled trial investigated whether a video intervention delivered in the emergency department (ED), cortisol measured at the ED, and prior rape history predicted postrape suicidal ideation independently or in combination with the other predictors. Participants were 235 women aged 15-71 years who presented to the ED for a sexual assault medical forensic examination and were randomly assigned to either receive a video intervention that addressed avoidance and promoted healthy coping strategies or standard care prior to the examination. Participants also provided a blood sample for cortisol and completed at least one of three follow-ups at 6 weeks, 3 months, or 6 months postrape. The intervention conferred protection against suicidal ideation among women with elevated cortisol and a prior rape; however, it did not reduce risk for women without a prior rape, particularly those with elevated cortisol. It may be important to consider the influence of prior rape and neuroendocrine reactivity in developing treatments to address suicidal ideation among rape victims. More specifically, there appears to be value in screening victims for prior rape and administering this brief intervention to reduce suicidal ideation; however, other avenues should be explored for victims without a prior rape history. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"The intervention conferred protection against suicidal ideation among women with elevated cortisol and a prior rape; however, it did not reduce risk for women without a prior rape, particularly those with elevated cortisol.","['Participants were 235 women aged 15-71 years who presented to the ED for a sexual assault medical forensic examination', 'women with elevated cortisol and a prior rape', 'suicidal ideation among recent rape victims']","['video intervention that addressed avoidance and promoted healthy coping strategies or standard care prior to the examination', 'video intervention']","['protection against suicidal ideation', 'suicidal ideation', 'postrape suicidal ideation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0430449', 'cui_str': 'Forensic examination'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034668', 'cui_str': 'Forcible intercourse'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0277731', 'cui_str': 'Victim of rape'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",235.0,0.0293321,"The intervention conferred protection against suicidal ideation among women with elevated cortisol and a prior rape; however, it did not reduce risk for women without a prior rape, particularly those with elevated cortisol.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Walsh', 'Affiliation': 'Ferkauf Graduate School of Psychology.'}, {'ForeName': 'Christal L', 'Initials': 'CL', 'LastName': 'Badour', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Zuromski', 'Affiliation': 'National Crime Victims Research and Treatment Center.'}, {'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Gilmore', 'Affiliation': 'National Crime Victims Research and Treatment Center.'}, {'ForeName': 'Dean G', 'Initials': 'DG', 'LastName': 'Kilpatrick', 'Affiliation': 'National Crime Victims Research and Treatment Center.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'College of Nursing.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Resnick', 'Affiliation': 'National Crime Victims Research and Treatment Center.'}]",Psychological services,['10.1037/ser0000495']
574,33667113,Prolonged Usage of an Adhesive Wound Closure Device in Postoperative Facial Scar Management: A Split-Wound Randomized Controlled Trial.,"Background:  Additional skin support is promising in scar management, especially for wounds under high tension. Options for effective skin support are limited. This study aimed to determine whether prolonged use of an adhesive wound closure (AWC) device prevents scar spread and improves final appearance.  Patients and Methods:  This is a split-wound randomized evaluator-blinded study of 14 patients with facial wounds under high tension. After surgical closure, one half of each wound was randomly allocated to receive either standard care or additional 3-month treatment with an AWC device. Scar width, scar scale, and side effects were evaluated 12 months after surgery.  Results:  A significant difference was observed in scar width between the treated and nontreated sites at 12-month, with a mean difference of 1.024 (95% confidence interval, 0.347-1.700) mm in favor of the treated group. Scar widths in both groups increased rapidly in the first month after surgery and gradually increased until the sixth month. Scale for vascularization and relief were significantly lower in the treated sites. No significant differences were found in complications between two groups.  Conclusions and Relevance:  Prolonged usage of the AWC device prevented scar spread at 12 months and improved final scar scores in vascularization and relief. Clinical Trial Registration number: ChiCTR1900027155.",2021,Prolonged usage of the AWC device prevented scar spread at 12 months and improved final scar scores in vascularization and relief.,"['14 patients with facial wounds under high tension', 'Postoperative Facial Scar Management']","['Adhesive Wound Closure Device', 'adhesive wound closure (AWC) device', 'standard care or additional 3-month treatment with an AWC device']","['Scar widths', 'complications', 'final scar scores', 'Scar width, scar scale, and side effects', 'Scale for vascularization and relief', 'scar width']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2229249', 'cui_str': 'Scar of face'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1961336', 'cui_str': 'Skin-closure adhesive strip'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",14.0,0.0892753,Prolonged usage of the AWC device prevented scar spread at 12 months and improved final scar scores in vascularization and relief.,"[{'ForeName': 'Zongan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}]",Facial plastic surgery & aesthetic medicine,['10.1089/fpsam.2020.0574']
575,33677520,A Cultural Dance Program Improves Hypertension Control and Cardiovascular Disease Risk in Native Hawaiians: A Randomized Controlled Trial.,"BACKGROUND


Native Hawaiians have higher hypertension (HTN) and cardiovascular disease (CVD) rates than non-Hispanic whites, calling for culturally responsive interventions to close this gap.
PURPOSE


We tested the effects of a 6-month behavioral intervention, a cultural dance program based on hula (the customary dance of Hawai'i), for improving blood pressure (BP) and CVD risk among Native Hawaiians with uncontrolled HTN.
METHODS


In a randomized controlled trial, we tested the effects of the hula-based intervention among 263 Native Hawaiians with uncontrolled HTN (systolic ≥ 140 or ≥ 130 mmHg if diabetes) and no CVD at enrollment. All participants received a brief culturally tailored heart health education before random assignment to the hula-based intervention (n = 131) or the education-only waitlist control (n = 132). Intervention received hula lessons and group-based activities for 6 months. Control received only 1-week education through 6 months.
RESULTS


Intervention yielded greater reductions in systolic (-15.3 mmHg) and diastolic (-6.4 mmHg) BP than control (-11.8 and -2.6 mmHg, respectively) from baseline to 6 months (p < .05). At 6 months, 43% of intervention participants compared to 21% of controls achieved a HTN stage <130/80 mmHg (p < .001). The 10-year CVD risk reduction was two times greater for the intervention group than the control group based on the Framingham Risk Score calculator. All improvements for intervention participants were maintained at 12 months.
CONCLUSIONS


This trial represents one of the few rigorously conducted examinations of an Indigenous practice leveraged for health promotion, with implications for other ethnic populations.",2021,The 10-year CVD risk reduction was two times greater for the intervention group than the control group based on the Framingham Risk Score calculator.,"['140 or ≥ 130 mmHg if diabetes) and no CVD at enrollment', '263 Native Hawaiians with uncontrolled HTN (systolic ≥', 'Native Hawaiians']","[""behavioral intervention, a cultural dance program based on hula (the customary dance of Hawai'i"", 'Cultural Dance Program', 'hula lessons and group-based activities for 6 months', 'hula-based intervention', 'brief culturally tailored heart health education before random assignment to the hula-based intervention (n = 131) or the education-only waitlist control']","['blood pressure (BP) and CVD risk', 'Hypertension Control and Cardiovascular Disease Risk', 'systolic (-15.3 mmHg) and diastolic', '10-year CVD risk reduction', 'hypertension (HTN) and cardiovascular disease (CVD) rates']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0337920', 'cui_str': 'Hawaiians'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018619', 'cui_str': 'Hawaii state'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.054794,The 10-year CVD risk reduction was two times greater for the intervention group than the control group based on the Framingham Risk Score calculator.,"[{'ForeName': ""Joseph Keawe'aimoku"", 'Initials': 'JK', 'LastName': 'Kaholokula', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'Mele', 'Initials': 'M', 'LastName': 'Look', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Mabellos', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'Hyeong Jun', 'Initials': 'HJ', 'LastName': 'Ahn', 'Affiliation': ""Department of Quantitative Health Sciences, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'So Yung', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': ""Department of Quantitative Health Sciences, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': ""Ka'imi A"", 'Initials': 'KA', 'LastName': 'Sinclair', 'Affiliation': 'Institute for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wills', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'Todd B', 'Initials': 'TB', 'LastName': 'Seto', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'Māpuana', 'Initials': 'M', 'LastName': 'de Silva', 'Affiliation': ""Hālau Mōhala 'Ilima, Ka'ōhao, HI.""}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa127']
576,33685639,A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures.,,2021,,['Extra-articular Distal Tibial Fractures'],['Plating with Intramedullary Nailing'],[],"[{'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]",[],,0.11942,,"[{'ForeName': 'Rong-Xun', 'Initials': 'RX', 'LastName': 'Qian', 'Affiliation': 'Department of Joint Surgery, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu, 215300, China. Electronic address: qianrongxun2004@sina.com.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Department of Joint Surgery, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu, 215300, China. Electronic address: sgu8434@sina.com.'}]",Injury,['10.1016/j.injury.2021.02.073']
577,33674933,"A randomized, prospective trial to assess the safety and efficacy of hilotherapy in patients after orthognathic surgery.","PURPOSE


A post-operative cooling method in oral and maxillofacial surgery is the cooling with hilotherapy. The aim of this study was the post-operative comparison of cooling temperatures of 18°C and 22°C. The parameters of this trial were swelling and the post-operative pain levels.
METHODS


This study included 156 patients, divided into two groups among whom a mono-one, bignathic osteotomy or genioplasty was indicated. The post-operative assessment of swelling was performed using a 3D optical scanner. This examination was repeated on post-operative days 1, 2, 3, 7, 14, 30, and 90. The examination on day 90 served as a reference value in respect of swelling and pain.
RESULTS


Group 1 (18°C, 78 patients) showed an increase in post-operative swelling on the 1 st  post-OP day of 52.06 ± 35.41ml. The maximum was reached on the 2 nd  post-OP day with 75.82 ± 38.97ml. On the 30 th  post-OP day, residual swelling measured 11.60 ± 12.62ml. Group 2 (22 °C, 78 patients) showed an increase in postoperative swelling on the 1 st  post-OP day of 76.07 ± 63.15ml. The maximum was reached on the 2 nd  post-OP day with 106.97 ± 69.63 ml. On the 30 th  post-OP day, residual swelling measured 14.36 ± 32.26ml. The differences between the two groups and between different visits were statistically significant.
CONCLUSION


The study results indicate less residual swelling in group 1 on the 30 th  post-OP day, possible based on the lower cooling temperature. The post-operative pain exhibits a comparable level of pain intensity between the two groups. In overall terms, a subjectively more agreeable treatment was observed in group 1.",2021,"Group 2 (22 °C, 78 patients) showed an increase in postoperative swelling on the 1 st  post-OP day of 76.07 ± 63.15ml.","['156 patients, divided into two groups among whom a mono-one, bignathic osteotomy or genioplasty was indicated', '18°C and 22°C', 'patients after orthognathic surgery']",['hilotherapy'],"['safety and efficacy', 'pain intensity', 'postoperative swelling', 'residual swelling', 'post-operative swelling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0398907', 'cui_str': 'Genioplasty'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}]",156.0,0.0187628,"Group 2 (22 °C, 78 patients) showed an increase in postoperative swelling on the 1 st  post-OP day of 76.07 ± 63.15ml.","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bonitz', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dortmund General Hospital, Muensterstrasse 240, D-44145, Dortmund, Germany. lars.bonitz@klinikumdo.de.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'El-Karmi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dortmund General Hospital, Muensterstrasse 240, D-44145, Dortmund, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Linssen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dortmund General Hospital, Muensterstrasse 240, D-44145, Dortmund, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Abel', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dortmund General Hospital, Muensterstrasse 240, D-44145, Dortmund, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hassfeld', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dortmund General Hospital, Muensterstrasse 240, D-44145, Dortmund, Germany.'}, {'ForeName': 'Ákos', 'Initials': 'Á', 'LastName': 'Bicsák', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dortmund General Hospital, Muensterstrasse 240, D-44145, Dortmund, Germany.'}]",Oral and maxillofacial surgery,['10.1007/s10006-021-00948-w']
578,33675850,Health- and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis.,"PURPOSE


To evaluate changes in health-related and vision-related quality of life (VRQoL) among patients with noninfectious uveitis who were treated with antimetabolites.
DESIGN


Secondary analysis of a randomized controlled trial.
PARTICIPANTS


Patients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico.
METHODS


From 2013 through 2017, 216 participants were randomized to receive 25 mg weekly oral methotrexate or 1.5 g twice daily oral mycophenolate mofetil. Median changes in quality of life (QoL) were measured using Wilcoxon signed-rank tests, and differences between treatment groups were measured using linear mixed models, adjusting for baseline QoL score, age, gender, and site. Among Indian patients, VRQoL scores from a general scale (the National Eye Institute Visual Function Questionnaire [NEI-VFQ]) and a culturally specific scale (the Indian Visual Function Questionnaire [IND-VFQ]) were compared using Pearson correlation tests.
MAIN OUTCOME MEASURES


Vision-related QoL (NEI-VFQ and IND-VFQ) and health-related QoL (HRQoL; physical component score [PCS] and mental component score [MCS] of the Medical Outcomes Study 36-Item Short Form Survey [SF-36v2]) were measured at baseline, the primary end point (6 months or treatment failure before 6 months), and the secondary end point (12 months or treatment failure between 6 and 12 months).
RESULTS


Among 193 participants who reached the primary end point, VRQoL increased from baseline by a median of 12.0 points (interquartile range [IQR], 1.0-26.1, NEI-VFQ scale), physical HRQoL increased by a median of 3.6 points (IQR, -1.4 to 14.9, PCS SF-36v2), and mental HRQoL increased by a median of 3.0 points (IQR, -3.7 to 11.9, MCS SF-36v2). These improvements in NEI-VFQ, SF-36v2 PCS, and SF-36v2 MCS scores all were significant (P < 0.01). The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; P > 0.05 for all). The NEI-VFQ and IND-VFQ scores for Indian participants were correlated highly at baseline and the primary and secondary end points (correlation coefficients, 0.87, 0.80, and 0.90, respectively).
CONCLUSIONS


Among patients treated with methotrexate or mycophenolate mofetil for uveitis, VRQoL and HRQoL improved significantly over the course of 1 year and did not differ by treatment allocation. These findings suggest that antimetabolites could improve overall patient well-being and daily functioning.",2021,"The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; p > 0.05 for all).","['193 participants', 'From 2013-2017', 'Patients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico', 'patients with noninfectious uveitis who were treated with antimetabolites', 'Uveitis', '216 participants']","['mycophenolate mofetil', 'Methotrexate and Mycophenolate Mofetil', 'oral methotrexate', 'methotrexate or mycophenolate mofetil']","['uveitis, vision-related and health-related QoL', 'vision-related QoL scores', 'Vision-related (NEI-VFQ and IND-VFQ) and health-related (PCS (physical component score) and MCS (mental component score) SF-36v2) QoL', 'health-related and vision-related quality of life (QoL', 'vision-related QoL', 'NEI-VFQ, SF-36v2 PCS, and SF-36v2 MCS scores', 'NEI-VFQ and IND-VFQ scores', 'Health and Vision-Related Quality of Life', 'overall patient well-being and daily functioning', 'physical health-related QoL', 'Median changes in QoL', 'mental health-related QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003376', 'cui_str': 'Antimetabolite'}, {'cui': 'C4708905', 'cui_str': '216'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",216.0,0.171623,"The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; p > 0.05 for all).","[{'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Kelly', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Aheli', 'Initials': 'A', 'LastName': 'Chattopadhyay', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Rathinam', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Madurai, India.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gonzales', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Thundikandy', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Madurai, India.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Kanakath', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Coimbatore, India.'}, {'ForeName': 'S Bala', 'Initials': 'SB', 'LastName': 'Murugan', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Pondicherry, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vedhanayaki', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Madurai, India.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Cugley', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Suhler', 'Affiliation': ""Casey Eye Institute, Oregon Health and Science University, OHSU-PSU School of Public Health, and Portland Veterans' Affairs Health Care System, Portland, Oregon.""}, {'ForeName': 'Hassan A', 'Initials': 'HA', 'LastName': 'Al-Dhibi', 'Affiliation': 'Division of Vitreoretinal Surgery and Uveitis, King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Caleb D', 'Initials': 'CD', 'LastName': 'Ebert', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Elyse J', 'Initials': 'EJ', 'LastName': 'Berlinberg', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Nisha R', 'Initials': 'NR', 'LastName': 'Acharya', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California. Electronic address: nisha.acharya@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2021.02.024']
579,33667417,"Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial.","BACKGROUND


This trial assessed the efficacy and safety of the GLP-1 analogue once a week subcutaneous semaglutide 2·4 mg versus semaglutide 1·0 mg (the dose approved for diabetes treatment) and placebo for weight management in adults with overweight or obesity, and type 2 diabetes.
METHODS


This double-blind, double-dummy, phase 3, superiority study enrolled adults with a body-mass index of at least 27 kg/m 2  and glycated haemoglobin 7-10% (53-86 mmol/mol) who had been diagnosed with type 2 diabetes at least 180 days before screening. Patients were recruited from 149 outpatient clinics in 12 countries across Europe, North America, South America, the Middle East, South Africa, and Asia. Patients were randomly allocated (1:1:1) via an interactive web-response system and stratified by background glucose-lowering medication and glycated haemoglobin, to subcutaneous injection of semaglutide 2·4 mg, or semaglutide 1·0 mg, or visually matching placebo, once a week for 68 weeks, plus a lifestyle intervention. Patients, investigators, and those assessing outcomes were masked to group assignment. Coprimary endpoints were percentage change in bodyweight and achievement of weight reduction of at least 5% at 68 weeks for semaglutide 2·4 mg versus placebo, assessed by intention to treat. Safety was assessed in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT03552757 and is closed to new participants.
FINDINGS


From June 4 to Nov 14, 2018, 1595 patients were screened, of whom 1210 were randomly assigned to semaglutide 2·4 mg (n=404), semaglutide 1·0 mg (n=403), or placebo (n=403) and included in the intention-to-treat analysis. Estimated change in mean bodyweight from baseline to week 68 was -9·6% (SE 0·4) with semaglutide 2·4 mg vs -3·4% (0·4) with placebo. Estimated treatment difference for semaglutide 2·4 mg versus placebo was -6·2 percentage points (95% CI -7·3 to -5·2; p<0·0001). At week 68, more patients on semaglutide 2·4 mg than on placebo achieved weight reductions of at least 5% (267 [68·8%] of 388 vs 107 [28·5%] of 376; odds ratio 4·88, 95% CI 3·58 to 6·64; p<0·0001). Adverse events were more frequent with semaglutide 2·4 mg (in 353 [87·6%] of 403 patients) and 1·0 mg (329 [81·8%] of 402) than with placebo (309 [76·9%] of 402). Gastrointestinal adverse events, which were mostly mild to moderate, were reported in 256 (63·5%) of 403 patients with semaglutide 2·4 mg, 231 (57·5%) of 402 with semaglutide 1·0 mg, and 138 (34·3%) of 402 with placebo.
INTERPRETATION


In adults with overweight or obesity, and type 2 diabetes, semaglutide 2·4 mg once a week achieved a superior and clinically meaningful decrease in bodyweight compared with placebo.
FUNDING


Novo Nordisk.",2021,Adverse events were more frequent with semaglutide 2·4 mg (in 353 [87·6%] of 403 patients) and 1·0 mg (329 [81·8%] of 402) than with placebo (309 [76·9%] of 402).,"['adults with overweight or obesity, and type 2 diabetes', 'Patients were recruited from 149 outpatient clinics in 12 countries across Europe, North America, South America, the Middle East, South Africa, and Asia', 'adults with overweight or obesity, and type 2 diabetes (STEP 2', 'enrolled adults with a body-mass index of at least 27 kg/m 2  and glycated haemoglobin 7-10% (53-86 mmol/mol) who had been diagnosed with type 2 diabetes at least 180 days before screening', 'From June 4 to Nov 14, 2018, 1595 patients were screened, of whom 1210', 'Semaglutide 2·4']","['semaglutide 2·4 mg (n=404), semaglutide 1·0 mg (n=403), or placebo', 'placebo', 'interactive web-response system and stratified by background glucose-lowering medication and glycated haemoglobin, to subcutaneous injection of semaglutide 2·4 mg, or semaglutide 1·0 mg, or visually matching placebo']","['weight reductions', 'Adverse events', 'efficacy and safety', 'Safety', 'percentage change in bodyweight and achievement of weight reduction', 'Gastrointestinal adverse events', 'mean bodyweight']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0026068', 'cui_str': 'Middle east country'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",1595.0,0.717476,Adverse events were more frequent with semaglutide 2·4 mg (in 353 [87·6%] of 403 patients) and 1·0 mg (329 [81·8%] of 402) than with placebo (309 [76·9%] of 402).,"[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK; NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Færch', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Ole K', 'Initials': 'OK', 'LastName': 'Jeppesen', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Pakseresht', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Sue D', 'Initials': 'SD', 'LastName': 'Pedersen', 'Affiliation': 'C-ENDO Diabetes and Endocrinology Clinic Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Perreault', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX, USA.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Adie', 'Initials': 'A', 'LastName': 'Viljoen', 'Affiliation': 'Borthwick Diabetes Research Unit, Lister Hospital, Stevenage, UK.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: ildiko.lingvay@utsouthwestern.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)00213-0']
580,33667319,Prevention of depression in adults with long-term physical conditions.,"BACKGROUND


Major depression is one of the world's leading causes of disability in adults with long-term physical conditions compared to those without physical illness. This co-morbidity is associated with a negative prognosis in terms of increased morbidity and mortality rates, increased healthcare costs, decreased adherence to treatment regimens, and a substantial decline in quality of life. Therefore, preventing the onset of depressive episodes in adults with long-term physical conditions should be a global healthcare aim. In this review, primary or tertiary (in cases of preventing recurrences in those with a history of depression) prevention are the focus. While primary prevention aims at preventing the onset of depression, tertiary prevention comprises both preventing recurrences and prohibiting relapses. Tertiary prevention aims to address a depressive episode that might still be present, is about to subside, or has recently resolved. We included tertiary prevention in the case where the focus was preventing the onset of depression in those with a history of depression (preventing recurrences) but excluded it if it specifically focused on maintaining an condition or implementing rehabilitation services (relapse prevention). Secondary prevention of depression seeks to prevent the progression of depressive symptoms by early detection and treatment and may therefore be considered a 'treatment,' rather than prevention. We therefore exclude the whole spectrum of secondary prevention.
OBJECTIVES


To assess the effectiveness, acceptability and tolerability of psychological or pharmacological interventions, in comparison to control conditions, in preventing depression in adults with long-term physical conditions; either before first ever onset of depressive symptoms (i.e. primary prevention) or before first onset of depressive symptoms in patients with a history of depression (i.e. tertiary prevention).
SEARCH METHODS


We searched the Cochrane Common Mental Disorders Controlled Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO and two trials registries, up to 6 February 2020.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) of preventive psychological or pharmacological interventions, specifically targeting incidence of depression in comparison to treatment as usual (TAU), waiting list, attention/psychological placebo, or placebo. Participants had to be age 18 years or older, with at least one long-term physical condition, and no diagnosis of major depression at baseline (primary prevention). In addition, we included studies comprising mixed samples of patients with and without a history of depression, which explored tertiary prevention of recurrent depression. We excluded other tertiary prevention studies. We also excluded secondary preventive interventions. Primary outcomes included incidence of depression, tolerability, and acceptability. Secondary outcomes included severity of depression, cost-effectiveness and cost-utility.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane.
MAIN RESULTS


We included 11 RCTs, with one trial on psychological interventions, and 10 trials on pharmacological interventions. Data analyses on the psychological intervention (problem-solving therapy compared to TAU) included 194 participants with age-related macular degeneration. Data analyses on pharmacological interventions included 837 participants comparing citalopram (one trial), escitalopram (three trials), a mixed sample of fluoxetine/nortriptyline (one trial), melatonin (one trial), milnacipran (one trial), and sertraline (three trials), each to placebo. Included types of long-term physical conditions were acute coronary syndrome (one trial), breast cancer (one trial), head and neck cancer (two trials), stroke (five trials), and traumatic brain injury (one trial). Psychological interventions Very low-certainty evidence of one study suggests that problem solving therapy may be slightly more effective than TAU in preventing the incidence of depression, immediately post-intervention (odds ratio (OR) 0.43, 95% confidence interval (CI) 0.20 to 0.95; 194 participants). However, there may be little to no difference between groups at six months follow-up (OR 0.71, 95% CI 0.36 to 1.38; 190 participants; one study; very low-certainty evidence). No data were available regarding incidence of depression after six months. Regarding acceptability (drop-outs due to any cause), slightly fewer drop-outs occurred in the TAU group immediately post-intervention (OR 5.21, 95% CI 1.11 to 24.40; 206 participants; low-certainty evidence). After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence). This study did not measure tolerability. Pharmacological interventions Post-intervention, compared to placebo, antidepressants may be beneficial in preventing depression in adults with different types of long-term physical conditions, but the evidence is very uncertain (OR 0.31, 95% CI 0.20 to 0.49; 814 participants; nine studies; I 2  =0%; very low-certainty evidence). There may be little to no difference between groups both immediately and at six months follow-up (OR 0.44, 95% CI 0.08 to 2.46; 23 participants; one study; very low-certainty evidence) as well as at six to 12 months follow-up (OR 0.81, 95% CI 0.23 to 2.82; 233 participants; three studies; I 2  = 49%; very low-certainty evidence). There was very low-certainty evidence from five studies regarding the tolerability of the pharmacological intervention. A total of 669 adverse events were observed in 316 participants from the pharmacological intervention group, and 610 adverse events from 311 participants in the placebo group. There was very low-certainty evidence that drop-outs due to adverse events may be less frequent in the placebo group (OR 2.05, 95% CI 1.07 to 3.89; 561 participants; five studies; I 2  = 0%). There was also very low-certainty evidence that drop-outs due to any cause may not differ between groups either post-intervention (OR 1.13, 95% CI 0.73 to 1.73; 962 participants; nine studies; I 2  = 28%), or at six to 12 months (OR 1.13, 95% CI 0.69 to 1.86; 327 participants; three studies; I 2  = 0%).
AUTHORS' CONCLUSIONS


Based on evidence of very low certainty, our results may indicate the benefit of pharmacological interventions, during or directly after preventive treatment. Few trials examined short-term outcomes up to six months, nor the follow-up effects at six to 12 months, with studies suffering from great numbers of drop-outs and inconclusive results. Generalisation of results is limited as study populations and treatment regimes were very heterogeneous. Based on the results of this review, we conclude that for adults with long-term physical conditions, there is only very uncertain evidence regarding the implementation of any primary preventive interventions (psychological/pharmacological) for depression.",2021,"After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence).","['patients with a history of depression (i.e. tertiary prevention', 'Participants had to be age 18 years or older, with at least one long-term physical condition, and no diagnosis of major depression at baseline (primary prevention', '316 participants from the pharmacological intervention group, and 610 adverse events from 311 participants in the placebo group', '194 participants with age-related macular degeneration', '837 participants comparing citalopram (one trial), escitalopram (three trials), a mixed sample of', 'adults with long-term physical conditions', 'Included types of long-term physical conditions were acute coronary syndrome (one trial), breast cancer (one trial), head and neck cancer (two trials), stroke (five trials), and traumatic brain injury (one trial', 'patients with and without a history of depression, which explored tertiary prevention of recurrent depression']","['placebo', 'psychological intervention (problem-solving therapy compared to TAU', 'melatonin', 'preventive psychological or pharmacological interventions', 'fluoxetine/nortriptyline', 'sertraline', 'usual (TAU), waiting list, attention/psychological placebo, or placebo']","['severity of depression, cost-effectiveness and cost-utility', 'morbidity and mortality rates, increased healthcare costs', 'effectiveness, acceptability and tolerability', 'tolerability', 'incidence of depression, tolerability, and acceptability', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0679700', 'cui_str': 'Tertiary Prevention'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0560182', 'cui_str': 'Diagnosis not made'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0028420', 'cui_str': 'Nortriptyline'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",194.0,0.340148,"After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence).","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Kampling', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Clinic of Giessen and Marburg, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Bengel', 'Affiliation': 'Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Mittag', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research, Center for Medical Biometry and Statistics, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011246.pub2']
581,33684828,The effects of home visiting on mother-child interactions: Evidence from a randomized trial using dynamic micro-level data.,"BACKGROUND


Home visiting programs constitute an important policy to support vulnerable families with young children. One of their principal aims is to improve infant-parent relationships, so a key measure of their effectiveness is based on observational measures of parent-children interactions. In the present study we provide novel evidence on the effectiveness of home visiting programs in improving mother-child interactions within a randomized controlled trial (RCT) of the Pro Kind program. A major goal of the Pro Kind program is to promote child development by strengthening the intuitive parenting skills of mothers. On this basis, the following research question is addressed in this paper: What is the impact of the Pro Kind home visitation program on the quality of mother-child interaction?
METHODS


A randomly chosen subsample of the original sample was selected to participate on video recordings. This subsample of 109 mother-child dyads was videotaped during a 3-min typical play situation at the participants' homes when the child was aged 25 months. We use a novel micro-coding system which allows us to examine how the intervention affected the dynamic feedback responses of both mothers and children in three key measures of behavior: orientation, positive contingency, and negative/lack of contingency. The analysis was conducted using a set of static probit models and dynamic cross-lagged panel probit models for each measure.
RESULTS


The intervention significantly improved the interactions between girls and their mothers, by increasing the prevalence of orientation and positive contingency (and reducing that of negative/lack of contingency). This was achieved by increasing both the persistence of positive behaviors and also the probability of switching from negative to positive behaviors in the treatment group. Mixed impacts were detected for boys.
CONCLUSIONS


Overall, it can be said that the Pro Kind program has a positive impact on the quality of mother-daughter interaction. However, our findings might also influence the design and delivery of home visiting programs, to the extent that they suggest that more attention has to be devoted to the interactions between boys and their mothers. Furthermore, the results show the importance of careful dynamic modelling of interactions data from videotaped observations to have a more complete understanding of the effectiveness of home visiting programs.",2021,"The intervention significantly improved the interactions between girls and their mothers, by increasing the prevalence of orientation and positive contingency (and reducing that of negative/lack of contingency).","[""109 mother-child dyads was videotaped during a 3-min typical play situation at the participants' homes when the child was aged 25 months"", 'families with young children']","['home visiting', 'home visiting programs']",['prevalence of orientation and positive contingency'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557118', 'cui_str': 'Family with young children'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0241227,"The intervention significantly improved the interactions between girls and their mothers, by increasing the prevalence of orientation and positive contingency (and reducing that of negative/lack of contingency).","[{'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': 'Department of Economics and Social Research Institute, University College London, United Kingdom.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Poupakis', 'Affiliation': 'Institute for Global Health, University College London, United Kingdom. Electronic address: s.poupakis@ucl.ac.uk.'}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Sandner', 'Affiliation': 'Institute for Employment Research Institute, IAB, Germany.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Kliem', 'Affiliation': 'Ernst-Abbe-Hochschule Jena - University of Applied Sciences, Germany.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.105021']
582,33692190,Smart agent system for insulin infusion protocol management: a simulation-based human factors evaluation study.,"OBJECTIVE


To compare the insulin infusion management of critically ill patients by nurses using either a common standard (ie, human completion of insulin infusion protocol steps) or smart agent (SA) system that integrates the electronic health record and infusion pump and automates insulin dose selection.
DESIGN


A within subjects design where participants completed 12 simulation scenarios, in 4 blocks of 3 scenarios each. Each block was performed with either the manual standard or the SA system. The initial starting condition was randomised to manual standard or SA and alternated thereafter.
SETTING


A simulation-based human factors evaluation conducted at a large academic medical centre.
SUBJECTS


Twenty critical care nurses.
INTERVENTIONS


A systems engineering intervention, the SA, for insulin infusion management.
MEASUREMENTS


The primary study outcomes were error rates and task completion times. Secondary study outcomes were perceived workload, trust in automation and system usability, all measured with previously validated scales.
MAIN RESULTS


The SA system produced significantly fewer dose errors compared with manual calculation (17% (n=20) vs 0, p<0.001). Participants were significantly faster, completing the protocol using the SA system (p<0.001). Overall ratings of workload for the SA system were significantly lower than with the manual system (p<0.001). For trust ratings, there was a significant interaction between time (first or second exposure) and the system used, such that after their second exposure to the two systems, participants had significantly more trust in the SA system. Participants rated the usability of the SA system significantly higher than the manual system (p<0.001).
CONCLUSIONS


A systems engineering approach jointly optimised safety, efficiency and workload considerations.",2021,Overall ratings of workload for the SA system were significantly lower than with the manual system (p<0.001).,"['critically ill patients by nurses using either a common standard (ie, human completion of insulin infusion protocol steps) or', 'A simulation-based human factors evaluation conducted at a large academic medical centre', 'Twenty critical care nurses']",['smart agent (SA) system'],"['Overall ratings of workload for the SA system', 'usability of the SA system', 'workload, trust in automation and system usability, all measured with previously validated scales', 'error rates and task completion times']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0004376', 'cui_str': 'Automation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",20.0,0.0912765,Overall ratings of workload for the SA system were significantly lower than with the manual system (p<0.001).,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Rosen', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA mrosen44@jhmi.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Romig', 'Affiliation': 'Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Demko', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Barasch', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Dwyer', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Pronovost', 'Affiliation': 'University Hospitals of Cleveland, Shaker Heights, Ohio, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sapirstein', 'Affiliation': 'Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}]",BMJ quality & safety,['10.1136/bmjqs-2020-011420']
583,31818339,Effects of acute transcutaneous vagus nerve stimulation on emotion recognition in adolescent depression.,"BACKGROUND


Transcutaneous vagus nerve stimulation (tVNS) is a promising therapeutic option for major depressive disorder (MDD) in adults. Alternative third-line treatments for MDD in adolescents are scarce. Here we aimed to assess the effects of acute tVNS on emotion recognition in adolescents with MDD.
METHODS


Adolescents (14-17 years) with MDD (n = 33) and non-depressed controls (n = 30) received tVNS or sham-stimulation in a cross-sectional, case-control, within-subject cross-randomized controlled trial, while performing different tasks assessing emotion recognition. Correct responses, response times, and errors of omission and commission on three different computerized emotion recognition tasks were assessed as main outcomes. Simultaneous recordings of electrocardiography and electro dermal activity, as well as sampling of saliva for the determination of α-amylase, were used to quantify the effects on autonomic nervous system function.
RESULTS


tVNS had no effect on the recognition of gradually or static expressed emotions but altered response inhibition on the emotional Go/NoGo-task. Specifically, tVNS increased the likelihood of omitting a response toward sad target-stimuli in adolescents with MDD, while decreasing errors (independent of the target emotion) in controls. Effects of acute tVNS on autonomic nervous system function were found in non-depressed controls only.
CONCLUSIONS


Acute tVNS alters the recognition of briefly presented facial expressions of negative valence in adolescents with MDD while generally increasing emotion recognition in controls. tVNS seems to specifically alter early visual processing of stimuli of negative emotional valence in MDD. These findings suggest a potential therapeutic benefit of tVNS in adolescent MDD that requires further evaluation within clinical trials.",2021,"RESULTS


tVNS had no effect on the recognition of gradually or static expressed emotions but altered response inhibition on the emotional Go/NoGo-task.","['Adolescents (14-17 years) with MDD (n = 33) and non-depressed controls (n = 30) received', 'adolescents with MDD', 'major depressive disorder (MDD) in adults', 'adolescent depression']","['acute transcutaneous vagus nerve stimulation', 'Transcutaneous vagus nerve stimulation (tVNS', 'acute tVNS', 'tVNS or sham-stimulation']","['Correct responses, response times, and errors of omission and commission on three different computerized emotion recognition tasks', 'recognition of gradually or static expressed emotions', 'emotion recognition', 'autonomic nervous system function', 'likelihood of omitting a response toward sad target-stimuli']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}, {'cui': 'C0234593', 'cui_str': 'Autonomic nervous system function'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",33.0,0.0457609,"RESULTS


tVNS had no effect on the recognition of gradually or static expressed emotions but altered response inhibition on the emotional Go/NoGo-task.","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Koenig', 'Affiliation': 'Section for Experimental Child and Adolescent Psychiatry, Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg, Blumenstr. 8, 69115Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Parzer', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg, Blumenstr. 8, 69115Heidelberg, Germany.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Haigis', 'Affiliation': 'Section for Translational Psychobiology in Child and Adolescent Psychiatry, Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg, Blumenstr. 8, 69115Heidelberg, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Liebemann', 'Affiliation': 'Section for Translational Psychobiology in Child and Adolescent Psychiatry, Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg, Blumenstr. 8, 69115Heidelberg, Germany.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Jung', 'Affiliation': 'Section for Translational Psychobiology in Child and Adolescent Psychiatry, Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg, Blumenstr. 8, 69115Heidelberg, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Resch', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg, Blumenstr. 8, 69115Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kaess', 'Affiliation': 'University Hospital of Child and Adolescent Psychiatry and Psychotherapy, University of Bern, Stöckli, Bolligenstrasse 141c, 3000Bern 60, Switzerland.'}]",Psychological medicine,['10.1017/S0033291719003490']
584,33667479,PrecISE: Precision Medicine in Severe Asthma: An adaptive platform trial with biomarker ascertainment.,"Severe asthma accounts for almost half the cost associated with asthma. Severe asthma is driven by heterogeneous molecular mechanisms. Conventional clinical trial design often lacks the power and efficiency to target subgroups with specific pathobiological mechanisms. Furthermore, the validation and approval of new asthma therapies is a lengthy process. A large proportion of that time is taken by clinical trials to validate asthma interventions. The National Institutes of Health Precision Medicine in Severe and/or Exacerbation Prone Asthma (PrecISE) program was established with the goal of designing and executing a trial that uses adaptive design techniques to rapidly evaluate novel interventions in biomarker-defined subgroups of severe asthma, while seeking to refine these biomarker subgroups, and to identify early markers of response to therapy. The novel trial design is an adaptive platform trial conducted under a single master protocol that incorporates precision medicine components. Furthermore, it includes innovative applications of futility analysis, cross-over design with use of shared placebo groups, and early futility analysis to permit more rapid identification of effective interventions. The development and rationale behind the study design are described. The interventions chosen for the initial investigation and the criteria used to identify these interventions are enumerated. The biomarker-based adaptive design and analytic scheme are detailed as well as special considerations involved in the final trial design.",2021,The NIH Precision Medicine in Severe,['Severe'],[],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}]",[],[],,0.0427309,The NIH Precision Medicine in Severe,"[{'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Department of Medicine, Divisions of Pulmonary & Critical Care Medicine & Allergy & Immunology, Brigham & Women's Hospital, Harvard Medical School, Boston, Mass. Electronic address: eisrael@partners.org.""}, {'ForeName': 'Loren C', 'Initials': 'LC', 'LastName': 'Denlinger', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, Tenn.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'LaVange', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Moore', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Peters', 'Affiliation': 'University of California, San Francisco School of Medicine, San Francisco, Calif.'}, {'ForeName': 'Steve N', 'Initials': 'SN', 'LastName': 'Georas', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Rosalind J', 'Initials': 'RJ', 'LastName': 'Wright', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': 'Pennsylvania State University School of Medicine, Hershey, Pa.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Noel', 'Affiliation': 'Division of Lung Diseases, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Akuthota', 'Affiliation': 'Pulmonary Division, Department of Medicine, University of California-San Diego, La Jolla, Calif.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bach', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'Asthma and Airway Disease Research Center, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': 'Allergy and Immunology, University of South Florida, Tampa, Fla.'}, {'ForeName': 'Tara F', 'Initials': 'TF', 'LastName': 'Carr', 'Affiliation': 'Asthma and Airway Disease Research Center, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, Kan.'}, {'ForeName': 'Angeles', 'Initials': 'A', 'LastName': 'Cinelli', 'Affiliation': ""Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Suzy A A', 'Initials': 'SAA', 'LastName': 'Comhair', 'Affiliation': 'Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Ronina A', 'Initials': 'RA', 'LastName': 'Covar', 'Affiliation': 'National Jewish Health, Denver, Colo.'}, {'ForeName': 'Laura Crotty', 'Initials': 'LC', 'LastName': 'Alexander', 'Affiliation': 'Pulmonary Division, Department of Medicine, University of California-San Diego, La Jolla, Calif.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'DiMango', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Serpil C', 'Initials': 'SC', 'LastName': 'Erzurum', 'Affiliation': 'Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Fahy', 'Affiliation': 'University of California, San Francisco School of Medicine, San Francisco, Calif.'}, {'ForeName': 'Merritt L', 'Initials': 'ML', 'LastName': 'Fajt', 'Affiliation': 'University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Gaston', 'Affiliation': 'Wells Center for Pediatric Research, Indiana University, Indianapolis, Ind.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hoffman', 'Affiliation': 'Department of Radiology, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'University of Colorado School of Medicine, Aurora, Colo.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Jackson', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Pulmonary Division, Department of Medicine, University of California-San Diego, La Jolla, Calif.'}, {'ForeName': 'Nizar N', 'Initials': 'NN', 'LastName': 'Jarjour', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Health Studies, University of Chicago, Chicago, Ill.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Kenyon', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, University of California Davis School of Medicine, Davis, Calif.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kosorok', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'Asthma and Airway Disease Research Center, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Krishnan', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep, and Allergy, Department of Medicine, University of Illinois at Chicago, Chicago, Ill.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ""Lurie Children's Hospital, Chicago, Ill.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Liu', 'Affiliation': ""University of Colorado School of Medicine, Aurora, Colo; Children's Hospital Colorado, Aurora, Colo.""}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Liu', 'Affiliation': 'Pulmonary and Critical Care Medicine, Department of Medicine, the Johns Hopkins University, Baltimore, Md.'}, {'ForeName': 'Ngoc P', 'Initials': 'NP', 'LastName': 'Ly', 'Affiliation': 'University of California, San Francisco School of Medicine, San Francisco, Calif.'}, {'ForeName': 'M Alison', 'Initials': 'MA', 'LastName': 'Marquis', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Fernando D', 'Initials': 'FD', 'LastName': 'Martinez', 'Affiliation': 'Asthma and Airway Disease Research Center, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Moy', 'Affiliation': 'Rush University Medical Center, Chicago, Ill.'}, {'ForeName': 'Wanda K', 'Initials': 'WK', 'LastName': ""O'Neal"", 'Affiliation': 'Center for Environmental Medicine, Asthma, and Lung Biology, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Ortega', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Peden', 'Affiliation': 'Marsico Lung Institute, UNC CF Research Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""UH Rainbow Babies and Children's Hospitals, Cleveland, Ohio.""}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Northwestern University, Chicago, Ill.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""University of Colorado School of Medicine, Aurora, Colo; Children's Hospital Colorado, Aurora, Colo.""}, {'ForeName': 'W Gerald', 'Initials': 'WG', 'LastName': 'Teague', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, Va.'}, {'ForeName': 'Abigail F', 'Initials': 'AF', 'LastName': 'Tulchinsky', 'Affiliation': ""Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Pandurangan', 'Initials': 'P', 'LastName': 'Vijayanand', 'Affiliation': 'La Jolla Institute for Immunology, La Jolla, Calif.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'National Jewish Health, Denver, Colo; University of Colorado School of Medicine, Aurora, Colo.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Wenzel', 'Affiliation': 'University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'White', 'Affiliation': 'Section of Pulmonary and Critical Care Medicine, Department of Medicine, University of Chicago, Chicago, Ill.'}, {'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Zeki', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, University of California Davis School of Medicine, Davis, Calif.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.01.037']
585,33683700,"Kinetics of Intestinal Presence of Spores Following Oral Administration of Bacillus clausii Formulations: Three Single-Centre, Crossover, Randomised, Open-Label Studies.","BACKGROUND AND OBJECTIVE: Probiotics are live microorganisms that may provide benefits including the prevention of gastrointestinal disorders and other diseases. Enterogermina is a probiotic mix of spores from four strains of Bacillus clausii (O/C, T, N/R and SIN), available in several oral formulations. The objective of this analysis was to evaluate and compare the kinetic profiles of different formulations of Enterogermina-vial [E4 once daily (OD) and E2 twice daily (BID)], capsule [EC2 three times daily (TID)], oral powder for suspension (ES6 OD) and oral powder not requiring suspension (E6 OD) from two studies from 2012 (EUDRACT 2010-024497-19 and 2010-023187-41) and one study from 2016 (EUDRACT 2015-003330-27).
METHODS


B. clausii spores were counted in homogenised faecal samples (results expressed as counts per gram) or after culture at 37 °C for 24-36 h (results expressed as colony-forming units). Kinetics were assessed by area under the concentration-time curve (AUC), maximum concentration (C max ), time to maximum concentration (T max ) and spore presence/persistence.
RESULTS


In total, 22 subjects in each of the 2012 studies and 30 subjects in the 2016 study were randomised (mean age 25.0-33.8 years across studies). The mean (±SD) absolute faecal spore counts (in millions) expressed as AUC per hour were 270.7 ± 147.7 (E2 BID) and 213.8 ± 60.2 (E4 OD) in 2012 EGKINETIC4, 312.7 ± 218.0 (EC2 TID) and 319.0 ± 221.1 (ES6 OD) in 2012 EGKINETIC6, and 212.6 ± 118.0 (E6 OD) and 293.2 ± 247.2 (ES6 OD) in 2016 EGKINETIC6OP. The kinetic profiles of the different formulations of Enterogermina were similar, with superimposable AUC and daily curve profiles in each study up to the 8th day post dose. B. clausii spore presence/persistence in the intestine of healthy volunteers did not differ between the two formulations within each of the three studies. Enterogermina was well tolerated across all formulations and studies.
CONCLUSION


These results show different formulations of Enterogermina had similar kinetic profiles within each study; however, they also showed that probiotics could be associated with high variability. The European Medicines Agency guidelines are the current bioequivalence reference, although only the T max  parameter is used for high variability drugs. Due to the specific kinetics of probiotics, new parameters of bioequivalence could be necessary, considering, for example, variability via a parameter such as AUC.
TRIAL REGISTRATION


EUDRACT 2010-024497-19, 2010-023187-41 and 2015-003330-27.",2021,B. clausii spore presence/persistence in the intestine of healthy volunteers did not differ between the two formulations within each of the three studies.,"['2010-024497-19, 2010-023187-41 and 2015-003330-27', 'healthy volunteers', 'two studies from 2012 (EUDRACT 2010-024497-19 and 2010-023187-41) and one study from 2016 (EUDRACT 2015-003330-27', '22 subjects in each of the 2012 studies and 30 subjects in the 2016 study were randomised (mean age 25.0-33.8 years across studies']","['Enterogermina-vial [E4 once daily (OD) and E2 twice daily (BID)], capsule ', 'Bacillus clausii Formulations', 'oral powder for suspension (ES6 OD) and oral powder not requiring suspension (E6 OD']","['mean (±SD) absolute faecal spore counts', 'concentration-time curve (AUC), maximum concentration (C max ), time to maximum concentration (T max ) and spore presence/persistence']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1706398', 'cui_str': 'Vial - unit of product usage'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1034048', 'cui_str': 'Bacillus clausii'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C1160731', 'cui_str': 'Oral powder'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0038026', 'cui_str': 'Spore Count'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0038027', 'cui_str': 'Spores'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}]",22.0,0.117092,B. clausii spore presence/persistence in the intestine of healthy volunteers did not differ between the two formulations within each of the three studies.,"[{'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Navarra', 'Affiliation': 'Section of Pharmacology, Department of Healthcare surveillance and Bioethics, Catholic University Medical School, Catholic University of the Sacred Heart, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Milleri', 'Affiliation': 'Centro Ricerche Cliniche di Verona srl, Verona, Italy.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Perez Iii', 'Affiliation': 'Global Medical, Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Uboldi', 'Affiliation': 'CHC Medical Department, Sanofi, Italy. MariaChiara.Uboldi@sanofi.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pellegrino', 'Affiliation': 'CHC Medical Department, Sanofi, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Bois De Fer', 'Affiliation': 'Sanofi Consumer Health Care Analytical and Scientific Platforms, Sanofi Clinical Sciences and Operations, Paris, France.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Morelli', 'Affiliation': 'DiSTAS, Università Cattolica del Sacro Cuore, Piacenza, CR, Italy.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-021-00676-2']
586,33687692,A simulation-based pilot study of crisis checklists in the emergency department.,"Checklists can improve adherence to standardized procedures and minimize human error. We aimed to test if implementation of a checklist was feasible and effective in enhancing patient care in an emergency department handling internal medicine cases. We developed four critical event checklists and confronted volunteer teams with a series of four simulated emergency scenarios. In two scenarios, the teams were provided access to the crisis checklists in a randomized cross-over design. Simulated patient outcome plus statement of the underlying diagnosis defined the primary endpoint and adherence to key processes such as time to commence CPR represented the secondary endpoints. A questionnaire was used to capture participants' perception of clinical relevance and manageability of the checklists. Six teams of four volunteers completed a total of 24 crisis sequences. The primary endpoint was reached in 8 out of 12 sequences with and in 2 out of 12 sequences without a checklist (Odds ratio, 10; CI 1.11, 123.43; p = 0.03607, Fisher's exact test). Adherence to critical steps was significantly higher in all scenarios for which a checklist was available (performance score of 56.3% without checklist, 81.9% with checklist, p = 0.00284, linear regression model). All participants rated the checklist as useful and 22 of 24 participants would use the checklist in real life. Checklist use had no influence on CPR quality. The use of context-specific checklists showed a statistically significant influence on team performance and simulated patient outcome and contributed to adherence to standard clinical practices in emergency situations.",2021,"Adherence to critical steps was significantly higher in all scenarios for which a checklist was available (performance score of 56.3% without checklist, 81.9% with checklist, p = 0.00284, linear regression model).","['Six teams of four volunteers completed a total of 24 crisis sequences', 'emergency department handling internal medicine cases']",[],"['Adherence to critical steps', 'CPR quality', 'adherence to key processes such as time to commence CPR']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0018578', 'cui_str': 'Handling (Psychology)'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",[],"[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",4.0,0.0335437,"Adherence to critical steps was significantly higher in all scenarios for which a checklist was available (performance score of 56.3% without checklist, 81.9% with checklist, p = 0.00284, linear regression model).","[{'ForeName': 'Beatrice Billur', 'Initials': 'BB', 'LastName': 'Knoche', 'Affiliation': 'Department of Emergency Medicine, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Busche', 'Affiliation': 'Department of Emergency Medicine, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Grodd', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center-University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Hans-Jörg', 'Initials': 'HJ', 'LastName': 'Busch', 'Affiliation': 'Department of Emergency Medicine, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Soeren Sten', 'Initials': 'SS', 'LastName': 'Lienkamp', 'Affiliation': 'Department of Internal Medicine, Renal Division, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. soeren.lienkamp@uzh.ch.'}]",Internal and emergency medicine,['10.1007/s11739-021-02670-7']
587,33694035,Can we enhance compliance to treatment by performing a continuous positive airway pressure trial in obstructive sleep apnea?,"BACKGROUND


Although continuous positive airway pressure (CPAP) therapy is the most effective treatment for obstructive sleep apnea (OSA), it is not always easy to gain adherence to therapy. We aimed to evaluate how short-term CPAP application during the daytime before the titration night affects polysomnographic data and CPAP adherence in OSA.
METHODS


Patients with moderate to severe OSA for whom CPAP titration was recommended were prospectively randomized to daytime CPAP application (group 1) or usual care (group 2).  For group 1, CPAP was applied for 30-60 min in daytime conditions to acclimate patients to the device. An appointment was then made to perform CPAP titration with PSG. In group 2 (usual care), the first CPAP application was performed on the titration night. PSG recordings and titration night recordings of both groups were compared. All subjects were evaluated 1 month after the initiation of CPAP treatment.
RESULTS


Among 246 cases, first night data were similar in both groups. During the titration night, total sleep time, sleep efficiency, and time in stage N3 were significantly higher in patients who underwent the daytime CPAP trial. Adherence to CPAP treatment at first-month follow-up was significantly higher in the group 1 (5.7 ± 1.0 h/night) compared to the group 2 (3.9 ± 1.1 h/night, p < 0.001).
CONCLUSION


A short-term daytime CPAP trial in patients before the titration night may provide longer and more efficient sleep on the titration night and better CPAP adherence at one month.",2021,"During the titration night, total sleep time, sleep efficiency, and time in stage N3 were significantly higher in patients who underwent the daytime CPAP trial.","['Patients with moderate to severe OSA for whom CPAP titration', 'obstructive sleep apnea (OSA']","['daytime CPAP application (group 1) or usual care (group 2', 'continuous positive airway pressure (CPAP) therapy']","['total sleep time, sleep efficiency, and\xa0time in stage N3', 'PSG recordings and titration night recordings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C2960045', 'cui_str': 'Continuous positive airway pressure titration'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",,0.00943435,"During the titration night, total sleep time, sleep efficiency, and time in stage N3 were significantly higher in patients who underwent the daytime CPAP trial.","[{'ForeName': 'Elif Torun', 'Initials': 'ET', 'LastName': 'Parmaksız', 'Affiliation': 'Department of Chest Diseases, Health Sciences University, Kartal Dr Lutfi Kırdar City Hospital, Istanbul, Turkey. dreliftorun@yahoo.com.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-021-02340-0']
588,33710095,Individualized Placement and Support Supported Employment for Justice-involved Homeless and Unemployed Veterans.,"BACKGROUND


Homelessness is a significant issue affecting the general US population. Two subsets of the population overrepresented in the US homeless population are justice involved individuals and Veterans. However, relatively little research has addressed alleviating homelessness in justice-involved Veterans (JIV). One direction for addressing homelessness in this population is facilitating employment.
OBJECTIVE


This study examined differences in housing and employment outcomes between homeless JIV enrolled in 2 different vocational rehabilitation conditions.
METHODS


This study evaluates vocational outcomes of Veterans experiencing homelessness enrolled in a larger US Department of Veterans Affairs-funded study. Participants were randomized into 2 groups: those who participated in a job search group, the About Face Vocational Program (AFVP) and those who received AFVP plus Individualized Placement and Support, Supported Employment (AFVP+IPS-SE).
RESULTS


Participants who received supported employment plus group were significantly more likely to secure employment compared with group alone. This significant difference was also found in individuals who identified as chronically homeless. Furthermore, participants who secured employment were significantly more likely to exit homelessness and secure housing, suggesting group membership had an indirect effect on housing status though improved employment outcomes.
CONCLUSIONS


Vocational rehabilitation groups combined with supported employment is appropriate and effective for homeless, JIV seeking employment and may also improve downstream housing outcomes.",2021,"CONCLUSIONS


Vocational rehabilitation groups combined with supported employment is appropriate and effective for homeless, JIV seeking employment and may also improve downstream housing outcomes.","['Justice-involved Homeless and Unemployed Veterans', 'homeless JIV enrolled in 2 different vocational rehabilitation conditions', 'Veterans experiencing homelessness enrolled in a larger US Department of Veterans Affairs-funded study']","['job search group, the About Face Vocational Program (AFVP) and those who received AFVP plus Individualized Placement and Support, Supported Employment (AFVP+IPS-SE', 'Individualized Placement and Support Supported Employment']",['secure employment'],"[{'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0034996', 'cui_str': 'Vocational rehabilitation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}]",,0.069799,"CONCLUSIONS


Vocational rehabilitation groups combined with supported employment is appropriate and effective for homeless, JIV seeking employment and may also improve downstream housing outcomes.","[{'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'LePage', 'Affiliation': 'VA North Texas Health Care System.'}, {'ForeName': 'William Blake', 'Initials': 'WB', 'LastName': 'Martin', 'Affiliation': 'VA North Texas Health Care System, University of Texas Southwestern Medical Center.'}, {'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Crawford', 'Affiliation': 'Dallas VA Research Corporation, Dallas, TX.'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Rock', 'Affiliation': 'VA North Texas Health Care System.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Parish Johnson', 'Affiliation': 'Dallas VA Research Corporation, Dallas, TX.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Washington', 'Affiliation': 'Dallas VA Research Corporation, Dallas, TX.'}]",Medical care,['10.1097/MLR.0000000000001445']
589,33710083,"Explaining Service Use and Residential Stability in Supported Housing: Problems, Preferences, Peers.","BACKGROUND


The behavioral model of health service use identified health needs, service preferences (predispositions), and service availability (enabling factors) as important predictors, but research has not conceptualized consistently each type of influence nor identified their separate effects on use of substance abuse and mental health services or their value in predicting service outcomes.
OBJECTIVES


To test hypotheses predicting use of substance abuse and mental health services and residential stability and evaluate peer specialists' impact.
RESEARCH DESIGN


Randomized trial of peer support added to standard case management in VA-supported housing program (Housing and Urban Development-VA Supportive Housing program).
SUBJECTS


One hundred sixty-six dually diagnosed Veterans in Housing and Urban Development-VA Supportive Housing program in 2 cities.
MEASURES


Average VA service episodes for substance abuse and mental illness; residential instability; preferences for alcohol, drug, and psychological services; extent of alcohol, drug, and psychological problems; availability of a peer specialist.
RESULTS


Self-assessed health needs, mediated by service preferences, and assignment to a peer specialist predicted use of VA behavioral health services and residential stability, as did chronic medical problems, sex, and race.
CONCLUSIONS


The behavioral model identifies major predictors of health service use and residential stability, but must recognize the mediating role of service preferences, the differing effects of alcohol and drug use, the unique influences of social background, and the importance of clinical judgment in needs assessment. Service availability and residential stability can be increased by proactive efforts involving peer specialists even in a health care system that provides services without a financial barrier.",2021,Service availability and residential stability can be increased by proactive efforts involving peer specialists even in a health care system that provides services without a financial barrier.,['One hundred sixty-six dually diagnosed Veterans in Housing and Urban Development-VA Supportive Housing program in 2 cities'],[],[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0041932', 'cui_str': 'Urban Development'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]",[],[],166.0,0.0342743,Service availability and residential stability can be increased by proactive efforts involving peer specialists even in a health care system that provides services without a financial barrier.,"[{'ForeName': 'Russell K', 'Initials': 'RK', 'LastName': 'Schutt', 'Affiliation': 'Department of Sociology, University of Massachusetts Boston.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schultz', 'Affiliation': 'Edith Nourse Rogers Veterans Hospital, Bedford, MA.'}, {'ForeName': 'Chantele', 'Initials': 'C', 'LastName': 'Mitchell-Miland', 'Affiliation': 'VA Pittsburgh Health Care System, Pittsburgh, PA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'VA Pittsburgh Health Care System, Pittsburgh, PA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chinman', 'Affiliation': 'VA Pittsburgh Health Care System, Pittsburgh, PA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Ellison', 'Affiliation': 'Edith Nourse Rogers Veterans Hospital, Bedford, MA.'}]",Medical care,['10.1097/MLR.0000000000001498']
590,33714428,Skeletal Muscle Fibre Type Changes in an Avian Model of Hepatic Fibrosis.,"We investigated the susceptibility of type I and type II skeletal myofibres to atrophy in hens with hepatic fibrosis induced by bile duct ligation (BDL). Seven hens, approximately 2 years old, were randomly assigned to BDL (n = 4) and sham surgery (SHAM) (n = 3) groups. Mean body weight and mean liver weight as a percentage of mean body weight were significantly lower in the BDL group than in the SHAM group at 4 weeks post surgery (P = 0.002, P = 0.005, respectively). Mean plasma aspartate aminotransferase activity was slightly higher, while total cholesterol (P <0.001), total bilirubin (P = 0.022) and NH 3  (P = 0.048) concentrations were significantly higher in the BDL group than in the SHAM group. Liver lesions were induced in all hens in the BDL group. The weights of the pectoralis (PCT) (P = 0.049) and flexor perforans et perforatus digiti III (FPPD III) muscles (P = 0.006) as a percentage of body weight were significantly decreased in the BDL group. A significantly reduced mean myofibre cross-sectional area in the PCT of BDL hens (P = 0.005) was indicative of atrophy. No significant differences were observed in the fibre type composition of the PCT, supracoracoideus or FPPD III muscles between the SHAM and BDL groups. However, there was an approximate 43% increase in the number of type I fibres in the femorotibialis lateralis of the BDL group and small angular type II fibres and large round type I fibres in this muscle were characteristic of peripheral neuropathy. The results suggest that type II fibres are more susceptible to atrophy than type I fibres in this model of hepatic fibrosis.",2021,"No significant differences were observed in the fibre type composition of the PCT, supracoracoideus or FPPD III muscles between the SHAM and BDL groups.","['hens with hepatic fibrosis induced by bile duct ligation (BDL', 'Seven hens, approximately 2 years old']","['sham surgery (SHAM', 'BDL', 'SHAM']","['Mean plasma aspartate aminotransferase activity', 'fibre type composition of the PCT, supracoracoideus or FPPD III muscles', 'percentage of body weight', 'flexor perforans et perforatus digiti III (FPPD III) muscles', 'mean myofibre cross-sectional area', 'total cholesterol', 'Mean body weight and mean liver weight as a percentage of mean body weight', 'number of type I fibres', 'weights of the pectoralis (PCT', 'Liver lesions', 'total bilirubin']","[{'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0005400', 'cui_str': 'Bile duct structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005400', 'cui_str': 'Bile duct structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0032452', 'cui_str': 'Polychlorotriphenyl Compounds'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}]",,0.0136789,"No significant differences were observed in the fibre type composition of the PCT, supracoracoideus or FPPD III muscles between the SHAM and BDL groups.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Nagasao', 'Affiliation': 'Department of Food Function and Safety, School of Veterinary Medicine, Kitasato University, Towada, Aomori, Japan. Electronic address: nagasao@vmas.kitasato-u.ac.jp.'}, {'ForeName': 'Hanae', 'Initials': 'H', 'LastName': 'Fukasawa', 'Affiliation': 'Department of Veterinary Anatomy, School of Veterinary Medicine, Kitasato University, Towada, Aomori, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Veterinary Anatomy, School of Veterinary Medicine, Kitasato University, Towada, Aomori, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Food Function and Safety, School of Veterinary Medicine, Kitasato University, Towada, Aomori, Japan.'}, {'ForeName': 'Yuna', 'Initials': 'Y', 'LastName': 'Iwaki', 'Affiliation': 'Department of Food Function and Safety, School of Veterinary Medicine, Kitasato University, Towada, Aomori, Japan.'}, {'ForeName': 'Kurumi', 'Initials': 'K', 'LastName': 'Kajiwara', 'Affiliation': 'Department of Food Function and Safety, School of Veterinary Medicine, Kitasato University, Towada, Aomori, Japan.'}, {'ForeName': 'Koudai', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Department of Food Function and Safety, School of Veterinary Medicine, Kitasato University, Towada, Aomori, Japan.'}, {'ForeName': 'Keizo', 'Initials': 'K', 'LastName': 'Arihara', 'Affiliation': 'Department of Food Function and Safety, School of Veterinary Medicine, Kitasato University, Towada, Aomori, Japan.'}]",Journal of comparative pathology,['10.1016/j.jcpa.2021.01.001']
591,33715955,Effects of Caffeinated and Decaffeinated Coffee on Hemodialysis-Related Headache (CoffeeHD): A Randomized Multicenter Clinical Trial.,"OBJECTIVES


Historically, headache was reported in up to 76% of hemodialysis patients. Some authors suggested that headache resulted from caffeine withdrawal. This study aims to compare the incidence of headache and hypotension between patients drinking regular or decaffeinated coffee during dialysis.
METHODS


One-hundred fifty-six patients were enrolled in this randomized, double-blind, placebo-controlled, multicenter study. Patients with atrial fibrillation were excluded. Group A was given 80 mL of regular coffee and group B 80 mL of decaffeinated coffee (placebo) in the middle of the session for 12 consecutive sessions. Ultrafiltration rate was fixed to a maximum of 13 mL/kg/hour. The primary outcome was the incidence of headache during dialysis.
RESULTS


A total of 139 patients completed the trial (6.4% vs. 15.4% of withdrawal in Groups A and B, respectively). The number of sessions with headache was not significantly different between Group A and B (33.3% vs. 37.1% respectively, P = .522), nor the number of sessions with hypotension (27% vs. 26% respectively, P = .539). In a subgroup analysis, headache tended to be more frequent in Group B (P = .06) in 2 categories of patients: those with the highest potassium dialysate (K = 2) and the non-hypertensive patients.
CONCLUSIONS


Headache occurred in 35% of patients during their chronic hemodialysis sessions. Caffeine intake did not prevent headache occurrence in these patients.",2021,"In a subgroup analysis, headache tended to be more frequent in Group B (P = .06) in 2 categories of patients: those with the highest potassium dialysate (K = 2) and the non-hypertensive patients.
","['Hemodialysis-Related Headache (CoffeeHD', 'patients drinking regular or decaffeinated coffee during dialysis', 'Patients with atrial fibrillation', 'One-hundred fifty-six patients']","['placebo', '80\xa0mL of regular coffee and group B 80\xa0mL of decaffeinated coffee (placebo', 'Caffeine', 'Caffeinated and Decaffeinated Coffee']","['incidence of headache during dialysis', 'headache', 'Headache', 'headache and hypotension', 'number of sessions with hypotension', 'number of sessions with headache', 'Ultrafiltration rate', 'headache occurrence']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",156.0,0.170569,"In a subgroup analysis, headache tended to be more frequent in Group B (P = .06) in 2 categories of patients: those with the highest potassium dialysate (K = 2) and the non-hypertensive patients.
","[{'ForeName': 'Mabel H', 'Initials': 'MH', 'LastName': 'Aoun', 'Affiliation': 'Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon; Department of Nephrology, Saint-Georges Hospital, Ajaltoun, Lebanon. Electronic address: mabel.aoun@usj.edu.lb.'}, {'ForeName': 'Najla', 'Initials': 'N', 'LastName': 'Hilal', 'Affiliation': 'Department of Nephrology, Saint-Georges Hospital, Ajaltoun, Lebanon.'}, {'ForeName': 'Chadia', 'Initials': 'C', 'LastName': 'Beaini', 'Affiliation': 'Department of Nephrology, Bellevue Medical Center, Mansourieh, Lebanon.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'Sleilaty', 'Affiliation': 'Department of Biostatistics and Clinical Research Center, Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon; Department of Cardiovascular Surgery, Hôtel-Dieu de France Hospital, Beirut, Lebanon.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Hajal', 'Affiliation': 'Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon; Department of Nephrology, Hôtel-Dieu de France Hospital, Beirut, Lebanon.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Boueri', 'Affiliation': 'Department of Nephrology, Saint-Georges Hospital, Ajaltoun, Lebanon.'}, {'ForeName': 'Dania', 'Initials': 'D', 'LastName': 'Chelala', 'Affiliation': 'Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon; Department of Nephrology, Hôtel-Dieu de France Hospital, Beirut, Lebanon.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2021.01.025']
592,33715054,Three-dimensional volumetric changes of 5 different bone grafts in human maxillary sinuses reconstruction: a randomized clinical study.,"PURPOSE


This study aimed to compare the three-dimensional volumetric changes of human maxillary sinuses after reconstruction using 5 different bone grafts.
PATIENTS AND METHODS


Patients underwent unilateral maxillary sinus bone height reconstruction using 5 bone substitutes allocated in different groups as follows: group 1 was grafted with autogenous bone graft alone; group 2 with beta-tricalcium phosphate (β-TCP); group 3 with β-TCP + autogenous bone graft 1:1; group 4 with bioactive glass; and group 5 with bioactive glass + autogenous bone graft 1:1. The patients were submitted to cone beam computed tomography in two periods: 15 days after the surgical procedure (T1) and after 6 months (T2). The results were evaluated as the formula T2-T1 expressing the three-volumetric changes of the biomaterials in elapsed time.
RESULTS


The resorption rate of autogenous bone graft was -630.699 ± 300.9 mm 3 ; in the β-TCP group, it was -315.772 ± 125.6 mm 3 ; in the group with β-TCP + autogenous bone graft 1:1, it was -336.205 ± 195.7 mm 3 ; and in groups with bioactive glass and with the addition of autogenous bone graft 1:1, it was -428.878 ± 311.6 mm 3  and -576.917 ± 471.6 mm 3 , respectively, without statistical difference (p = 0.167). Pearson's correlated test revealed a strong correlation as well as a progressive resorption of the grafts during bone healing.
CONCLUSION


The similar outcomes for the three-dimensional volumetric changes using the bone substitutes evaluated after 6 months of bone healing suggest that all these grafts can be performed to maxillary sinus reconstruction.",2021,"The resorption rate of autogenous bone graft was -630.699 ± 300.9 mm 3 ; in the β-TCP group, it was -315.772 ± 125.6 mm 3 ;","['human maxillary sinuses reconstruction', 'Patients underwent', 'human maxillary sinuses after reconstruction using 5 different bone grafts']","['unilateral maxillary sinus bone height reconstruction using 5 bone substitutes', 'autogenous bone graft alone; group 2 with beta-tricalcium phosphate (β-TCP', 'β-TCP + autogenous bone graft', 'β-TCP + autogenous bone graft 1:1; group 4 with bioactive glass; and group 5 with bioactive glass + autogenous bone graft 1:1']",['resorption rate of autogenous bone graft'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0106141', 'cui_str': 'beta-tricalcium phosphate'}, {'cui': 'C0044091', 'cui_str': '1-(1-(2-thienyl) cyclohexyl) piperidine'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}]",,0.0159181,"The resorption rate of autogenous bone graft was -630.699 ± 300.9 mm 3 ; in the β-TCP group, it was -315.772 ± 125.6 mm 3 ;","[{'ForeName': 'Juliana Dreyer', 'Initials': 'JD', 'LastName': 'Menezes', 'Affiliation': 'Universidade Estadual Paulista - UNESP, Ilha Solteira, Brazil.'}, {'ForeName': 'Rodrigo Dos Santos', 'Initials': 'RDS', 'LastName': 'Pereira', 'Affiliation': 'Universidade do Grande Rio - UNIGRANRIO, Duque de Caxias, Brazil. dr.pereira@live.com.'}, {'ForeName': 'Anderson Maikon de Souza', 'Initials': 'AMS', 'LastName': 'Santos', 'Affiliation': 'Universidade Estadual Paulista - UNESP, Ilha Solteira, Brazil.'}, {'ForeName': 'Natália Barbosa', 'Initials': 'NB', 'LastName': 'de Siqueira', 'Affiliation': 'Universidade Estadual Paulista - UNESP, Ilha Solteira, Brazil.'}, {'ForeName': 'Fernanda Brasil Daura Jorge', 'Initials': 'FBDJ', 'LastName': 'Boos-Lima', 'Affiliation': 'Universidade Federal de Minas Gerais - UFMG, Belo Horizonte, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Hochuli-Vieira', 'Affiliation': 'Universidade Estadual Paulista - UNESP, Ilha Solteira, Brazil.'}]",Oral and maxillofacial surgery,['10.1007/s10006-021-00940-4']
593,33714801,Enhancing breastfeeding establishment in preterm infants: A randomized clinical trial of two non-nutritive sucking approaches.,"BACKGROUND


Preterm infants and their mothers face many barriers to the establishment of exclusive breastfeeding in the neonatal intensive care unit.
OBJECTIVE


The objective of this study was to assess and compare the effect of maternally administered non-nutritive sucking (NNS) on an emptied breast versus a pacifier on exclusive breastfeeding establishment at hospital discharge.
STUDY DESIGN


A block randomized study design was performed.
TRIAL REGISTRATION NUMBER


NCT03434743.
METHODS


A total of 33 preterm infants born less than or equal to 34 weeks gestation participated in the study. The NNS on an emptied breast or pacifier interventions were administered by mothers, once a day for 15 min. Outcomes included: exclusive breastfeeding acquisition, described as infants who received greater than or equal to 50% of direct breastfeeds at hospital discharge; time to achieve independent oral feeding, defined as the number of days to transition from complete tube feeds to full oral feeds (full breast, partial breast/bottle, or full bottle); length of hospitalization, described as the number of days from admission to hospital discharge.
RESULTS


A significantly greater number of infants in the NNS emptied breast group acquired exclusive breastfeeds at hospital discharge as compared with those in the NNS pacifier group (63% vs. 24%, p = 0.037). There was no difference between groups in time to achieve independent oral feeds (14.4 ± 8.0 vs. 14.4 ± 6.4 days, p = 0.683) and length of hospital stay (48.7 ± 33.7 vs. 53.1 ± 30.6 days, p = 0.595).
CONCLUSION


Provision of NNS on an emptied breast is a safe and low-cost infant and mother targeted intervention which can increase exclusive breastfeeding rates and its well-recognized advantages in a highly vulnerable population.",2021,"A significantly greater number of infants in the NNS emptied breast group acquired exclusive breastfeeds at hospital discharge as compared with those in the NNS pacifier group (63% vs. 24%, p = 0.037).","['33 preterm infants born less than or equal to 34\xa0weeks gestation participated in the study', 'preterm infants']",['maternally administered non-nutritive sucking (NNS'],"['length of hospital stay', 'direct breastfeeds at hospital discharge; time to achieve independent oral feeding, defined as the number of days to transition from complete tube feeds to full oral feeds (full breast, partial breast/bottle, or full bottle); length of hospitalization, described as the number of days from admission to hospital discharge', 'time to achieve independent oral feeds']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1271035', 'cui_str': 'Provision of non-nutritive sucking'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",33.0,0.04567,"A significantly greater number of infants in the NNS emptied breast group acquired exclusive breastfeeds at hospital discharge as compared with those in the NNS pacifier group (63% vs. 24%, p = 0.037).","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Fucile', 'Affiliation': ""School of Rehabilitation Therapy, Queen's University, Canada; Department of Pediatrics, Queen's University, Canada. Electronic address: sandra.fucile@queensu.ca.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wener', 'Affiliation': ""Department of Pediatrics, Queen's University, Canada.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Dow', 'Affiliation': ""Department of Pediatrics, Queen's University, Canada.""}]",Early human development,['10.1016/j.earlhumdev.2021.105347']
594,33693713,Vitamin D Supplementation for Prevention of Cancer: The D2d Cancer Outcomes (D2dCA) Ancillary Study.,"CONTEXT


Observational studies suggest that low vitamin D status may be a risk factor for cancer.
OBJECTIVE


In a population with prediabetes and overweight/obesity that is at higher risk of cancer than the general population, we sought to determine if vitamin D supplementation lowers the risk of cancer and precancers.
METHODS


The Vitamin D and type 2 diabetes (D2d) cancer outcomes study (D2dCA) is an ancillary study to the D2d study, which was conducted at 22 academic medical centers in the United States. Participants had prediabetes and overweight/obesity and were free of cancer for the previous 5 years. Participants were randomized to receive vitamin D3 4000 IU daily or placebo. At scheduled study visits (4 times/year), cancer and precancer events were identified by questionnaires. Clinical data were collected and adjudicated for all reported events. Cox proportional hazard models compared the hazard ratio (HR) of incident cancers and precancers between groups.
RESULTS


Over a median follow-up period of 2.9 years, among 2385 participants (mean age 60 years and 25-hydroxyvitamin D 28 ng/mL), there were 89 cases of cancer. The HR of incident cancer for vitamin D vs placebo was 1.07 (95% CI 0.70, 1.62). Of 241 participants with incident precancers, 239 had colorectal adenomatous polyps. The HR for colorectal polyps for vitamin D vs placebo was 0.83 (95% CI 0.64, 1.07).
CONCLUSION


In the D2d population of participants with prediabetes and overweight/obesity, not selected for vitamin D insufficiency, vitamin D supplementation did not have a significant effect on risk of incident cancer or colorectal polyps.",2021,The HR for colorectal polyps for vitamin D vs. placebo was 0.83,"['Participants had prediabetes and overweight/obesity and were free of cancer for the previous 5 years', '2385 participants (mean age 60 years and 25-hydroxyvitamin D 28\xa0ng/mL), there were 89 cases of cancer', 'participants with prediabetes and overweight/obesity not selected for vitamin D insufficiency', 'and type 2 diabetes (D2d) study', '241 participants with incident precancers, 239 had colorectal adenomatous polyps', 'Twenty-two US academic medical centers']","['Vitamin D supplementation', 'Vitamin D', 'vitamin D vs. placebo', 'Vitamin D3 4000 IU daily or placebo', 'vitamin D supplementation']","['cancer and precancer outcomes', 'risk of incident cancer or colon polyps']","[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0206677', 'cui_str': 'Adenomatous polyp'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009376', 'cui_str': 'Polyp of colon'}]",241.0,0.793459,The HR for colorectal polyps for vitamin D vs. placebo was 0.83,"[{'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC 27713, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fuss', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA 02111, USA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Vickery', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA 02111, USA.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'LeBlanc', 'Affiliation': 'Center for Health Research, Kaiser Permanente NW, Portland, OR 97227, USA.'}, {'ForeName': 'Patricia R', 'Initials': 'PR', 'LastName': 'Sheehan', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA 02111, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Lewis', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Vermont, Burlington, VT 05401, USA.'}, {'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Dolor', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC 27713, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN 38105, USA.'}, {'ForeName': 'Sangeeta R', 'Initials': 'SR', 'LastName': 'Kashyap', 'Affiliation': 'Department of Endocrinology, Diabetes, and Metabolism, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Tufts CTSI, BERD Center, Tufts Medical Center, Boston, MA 02111, USA.'}, {'ForeName': 'Anastassios G', 'Initials': 'AG', 'LastName': 'Pittas', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA 02111, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab153']
595,33712090,Very preterm infants engage in an intervention to train their control of attention: results from the feasibility study of the Attention Control Training (ACT) randomised trial.,"BACKGROUND


Very premature birth (gestational age between 28 and 31 + 6 weeks) is associated with increased risk of cognitive delay and attention deficit disorder, which have been linked to anomalies in the development of executive functions (EFs) and their precursors. In particular, very preterm (VP) infants display anomalies in controlling attention and gathering task-relevant information. Early interventions that support attention control may be pivotal in providing a secure base for VP children's later attainments. The Attention Control Training (ACT) is a cognitive training intervention that targets infants' abilities to select visual information according to varying task demands but had not been tested in VP infants. We conducted a feasibility study to test the processes we intend to use in a trial delivering the ACT to VP infants.
METHODS AND DESIGN


We tested recruitment and retention of VP infants and their families in a randomised trial, as well as acceptability and completion of baseline and outcome measures. To evaluate these aims, we used descriptive quantitative statistics and qualitative methods to analyse feedback from infants' caregivers. We also investigated the quality of eye-tracking data collected and indicators of infants' engagement in the training, using descriptive statistics.
RESULTS


Twelve VP infants were recruited, and 10 (83%) completed the study. Participants' parents had high education attainment. The rate of completion of baseline and outcome measures was optimal. VP infants demonstrated engagement in the training, completing on average 84 min of training over three visits, and displaying improved performance during this training. Eye-tracking data quality was moderate, but this did not interfere with infants' engagement in the training.
DISCUSSION


The results suggest the ACT can be delivered to VP infants. However, challenges remain in recruitment of numerous and diverse samples. We discuss strategies to overcome these challenges informed by results of this study.
TRIAL REGISTRATION


Registered Registration ID: NCT03896490 . Retrospectively registered at Clinical Trials Protocol Registration and Results System ( clinicaltrials.gov ).",2021,"VP infants demonstrated engagement in the training, completing on average 84 min of training over three visits, and displaying improved performance during this training.","['Twelve VP infants were recruited, and 10 (83%) completed the study', ""infants' caregivers"", ""Participants' parents had high education attainment"", 'Very premature birth (gestational age between 28 and 31 + 6\u2009weeks']","['ACT', 'Registered Registration ID', 'Attention Control Training (ACT']",[],"[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0424933', 'cui_str': 'Higher education'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",[],,0.0947662,"VP infants demonstrated engagement in the training, completing on average 84 min of training over three visits, and displaying improved performance during this training.","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Perra', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Building, 97 Lisburn Road, Belfast, BT9 7BL, UK. o.perra@qub.ac.uk.""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Wass', 'Affiliation': 'School of Psychology, University of East London, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McNulty', 'Affiliation': 'TinyLife, The Premature Baby Charity for Northern Ireland, Belfast, Northern Ireland, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sweet', 'Affiliation': 'Health and Social Care Belfast Trust, Belfast, Northern Ireland, UK.'}, {'ForeName': 'Kostas A', 'Initials': 'KA', 'LastName': 'Papageorgiou', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Johnston', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Building, 97 Lisburn Road, Belfast, BT9 7BL, UK.""}, {'ForeName': 'Delfina', 'Initials': 'D', 'LastName': 'Bilello', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Building, 97 Lisburn Road, Belfast, BT9 7BL, UK.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Patterson', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Alderdice', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00809-z']
596,33694167,Do children use logic to spell logician? Implicit versus explicit teaching of morphological spelling rules.,"BACKGROUND


Intervention studies have reported the advantage of teaching children about morphemes for spelling, but direct comparisons between explicit and implicit teaching have been examined systematically in relation to only a few morphological rules.
AIMS


This study compared explicit versus implicit teaching of the functional rule for the conservation of stem morphemes in derived words in English (e.g., logic is conserved in the derivative logician in spite of changes in pronunciation).
SAMPLE


Participants (n = 90; 7- to 9-year-olds) were drawn from three schools with a diverse intake.
METHODS


The design included a pre-test and two post-intervention tests. Participants were randomly assigned to one of three groups: an explicit group, taught about stems and their conservation in derived words; an implicit group, exposed to the same stems and derivatives without explicit teaching; and an unseen control group. At pre- and post-test, the children's spelling of stems in derivatives was assessed. The interventions involved practice games in which the children spelled derived words after seeing the base forms; the explicit group discussed the connection between the spellings, whereas the implicit group did not.
RESULTS


Analyses of variance revealed that explicit teaching led to more significant spelling improvements than implicit or no teaching, and this effect held at both post-tests.
CONCLUSIONS


It was concluded that explicit teaching of the stem conservation rule in derived forms combined with appropriate practice games shows a sustained effect on spelling. The evidence supports explicit teaching of this morphological rule in classroom practice.",2021,"Analyses of variance revealed that explicit teaching led to more significant spelling improvements than implicit or no teaching, and this effect held at both post-tests.
","['SAMPLE\n\n\nParticipants (n\xa0', '7- to 9-year-olds) were drawn from three schools with a diverse intake', '90']","['implicit group did not', 'explicit group, taught about stems and their conservation in derived words; an implicit group, exposed to the same stems and derivatives without explicit teaching; and an unseen control group']",[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0399783,"Analyses of variance revealed that explicit teaching led to more significant spelling improvements than implicit or no teaching, and this effect held at both post-tests.
","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Burton', 'Affiliation': 'Department of Education, University of Oxford, UK.'}, {'ForeName': 'Terezinha', 'Initials': 'T', 'LastName': 'Nunes', 'Affiliation': 'Department of Education, University of Oxford, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Evangelou', 'Affiliation': 'Department of Education, University of Oxford, UK.'}]",The British journal of educational psychology,['10.1111/bjep.12414']
597,33711380,Characterizing New-Onset Exudation in the Randomized Phase 2 FILLY Trial of Complement Inhibitor Pegcetacoplan for Geographic Atrophy.,"OBJECTIVES


To evaluate clinical characteristics of eyes in which investigator-determined new-onset exudative age-related macular degeneration (eAMD) developed during the FILLY trial.
DESIGN


Post hoc analysis of the phase 2 study of intravitreal pegcetacoplan in geographic atrophy (GA).
SUBJECTS


Patients with GA secondary to age-related macular degeneration (AMD), n = 246.
INTERVENTION


Either 15 mg intravitreal pegcetacoplan or sham given monthly or every other month for 12 months followed by a 6-month off-treatment period.
MAIN OUTCOME MEASURES


Time of new eAMD onset in the study eye, history of eAMD in the fellow eye, presence of double-layer sign (DLS) on structural OCT in the study eye, changes in retinal anatomic features by structural OCT and fluorescein angiography (FA), and changes in visual acuity.
RESULTS


Exudation was reported in 26 study eyes across treatment groups over 18 months. Mean time to eAMD diagnosis was 256 days (range, 31-555 days). Overall, a higher proportion of patients with a baseline history of eAMD in the fellow eye (P = 0.016) and a DLS in the study eye (P = 0.0001) demonstrated eAMD. Among study eyes in which eAMD developed, 18 of 26 (69%) had history of fellow-eye eAMD and 19 of 26 (73.1%) had DLS at baseline, compared with 76 of 217 study eyes (35%; P = 0.0007) and 70 of 215 study eyes (32.5%; P < 0.0001), respectively, in which eAMD did not develop. All 21 patients with structural OCT imaging at the time of eAMD diagnosis demonstrated subretinal fluid, intraretinal cysts, or both consistent with exudation. Among 17 patients who underwent FA at eAMD diagnosis, 10 showed detectable macular neovascularization (MNV), all occult lesions. Development of eAMD did not have an appreciable impact on visual acuity, and all patients responded to anti-vascular endothelial growth factor (VEGF) therapy.
CONCLUSIONS


Intravitreal pegcetacoplan slowed the rate of GA growth and was associated with an unexpected dose-dependent increased incidence of eAMD with no temporal clustering of onset. Exudative AMD seemed to be associated with baseline eAMD in the contralateral eye and a DLS, suggestive of nonexudative MNV, in the study eye. The safety profile of pegcetacoplan was acceptable to proceed to phase 3 studies without adjustments to enrollment criteria.",2021,"Overall, a higher proportion of subjects with a history of eAMD in the fellow eye (P=0.016) and a DLS in the study eye at baseline (P=0.0001) developed eAMD.","['17 subjects who received FA at the time of eAMD diagnosis, 10 had detectable MNV, all occult lesions', 'All 21 subjects with structural OCT imaging at the time of eAMD diagnosis had subretinal fluid and/or intraretinal cysts', 'eyes that developed investigator-determined new-onset exudative age-related macular degeneration (eAMD', '246 subjects with GA secondary to AMD', 'geographic atrophy (GA']","['pegcetacoplan', 'intravitreal pegcetacoplan']","['history of fellow eye eAMD', 'eAMD', 'Time of onset of new eAMD in the study eye; history of eAMD in the fellow eye; presence of double layer sign (DLS) on structural optical coherence tomography (OCT) in the study eye; changes in retinal anatomy by structural OCT and fluorescein angiography (FA); and changes in visual acuity', 'rate of GA growth', 'visual acuity', 'Exudation', 'Mean time to diagnosis of eAMD']","[{'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",246.0,0.0934508,"Overall, a higher proportion of subjects with a history of eAMD in the fellow eye (P=0.016) and a DLS in the study eye at baseline (P=0.0001) developed eAMD.","[{'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas. Electronic address: charleswyckoff@gmail.com.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Rosenfeld', 'Affiliation': 'University of Miami Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Nadia K', 'Initials': 'NK', 'LastName': 'Waheed', 'Affiliation': 'Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Rishi P', 'Initials': 'RP', 'LastName': 'Singh', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Ronca', 'Affiliation': 'Apellis Pharmaceuticals, Leominster, Massachusetts.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Slakter', 'Affiliation': 'New York University School of Medicine, New York, New York.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Staurenghi', 'Affiliation': 'University of Milan-Bicocca: Universita degli Studi di Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Monés', 'Affiliation': 'Barcelona Macula Foundation, Barcelona, Spain.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Baumal', 'Affiliation': 'Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Saroj', 'Affiliation': 'Principal, All Eyes Consulting, LLC, New York, New York.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Metlapally', 'Affiliation': 'Apellis Pharmaceuticals, Leominster, Massachusetts.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': 'Apellis Pharmaceuticals, Leominster, Massachusetts.'}]",Ophthalmology,['10.1016/j.ophtha.2021.02.025']
598,33704925,"Evaluation of Pharmacokinetics, Safety, and Drug-Drug Interactions of an Oral Suspension of Edaravone in Healthy Adults.","Intravenous (IV) edaravone is approved as an amyotrophic lateral sclerosis (ALS) treatment. Because IV administration places a burden on patients, development of orally administered ALS treatments is needed. Therefore, 2 phase 1 studies of oral formulations of edaravone in healthy subjects examined the pharmacokinetics (PK), safety, racial differences, and drug-drug interactions (DDIs) and investigated the dose of the oral formulation considered to be bioequivalent to the approved dose of the IV formulation. Study 1 was a placebo-controlled, randomized, single-blind study of single-ascending-dose oral edaravone with the dose range of 30 to 300 mg (n = 56). Study 2 was conducted in 2 cohorts (n = 84); the first assessed DDIs with multiple-dose edaravone 120 mg/day given over 5 or 8 days (coadministered with single-dose rosuvastatin, sildenafil, or furosemide), and the second evaluated PK and racial (Japanese/White) differences in PK parameters with doses of 100-mg edaravone. The oral formulation of edaravone was well absorbed, and plasma concentrations of unchanged edaravone increased more than dose proportionally within the dose range of 30 to 300 mg. No effect of race on oral edaravone PK and no notable DDI effects possibly caused by orally administered edaravone were observed. The oral edaravone formulations were safe and tolerable under the assessed conditions. Mathematical modeling determined that equivalent exposures in plasma with the approved dose of the IV edaravone formulation, as reported previously, could be achieved when the oral edaravone formulation was administered at a dose of  ≈100 mg, with an absolute bioavailability of ≈60%.",2021,"The oral formulation of edaravone was well absorbed, and plasma concentrations of unchanged edaravone increased more than dose proportionally within the dose range of 30 to 300 mg.","['healthy subjects', 'Study 2 was conducted in 2 cohorts (n\xa0=\xa084', 'Healthy Adults']","['edaravone', 'single-ascending-dose oral edaravone', 'Intravenous (IV) edaravone', 'edaravone 120\xa0mg/day given over 5 or 8 days (coadministered with single-dose rosuvastatin, sildenafil, or furosemide', 'placebo', '100-mg edaravone']","['plasma concentrations of unchanged edaravone', 'pharmacokinetics (PK), safety, racial differences, and drug-drug interactions (DDIs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}]",,0.0832907,"The oral formulation of edaravone was well absorbed, and plasma concentrations of unchanged edaravone increased more than dose proportionally within the dose range of 30 to 300 mg.","[{'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Shimizu', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Shiide', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Matsuda', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Akimoto', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Munetomo', 'Initials': 'M', 'LastName': 'Matsuda', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Nakamaru', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuoki', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.925']
599,33709192,"Dexmedetomidine-soaked nasal packing can reduce pain and improve sleep quality after nasal endoscopic surgery: a double-blind, randomized, controlled clinical trial.","STUDY OBJECTIVE


Bilateral endoscopic nasal surgery is usually associated with pain and sleep disturbance. The aim of this study was to evaluate the effects of dexmedetomidine-soaked nasal packing on analgesia and improvement of sleep quality in patients undergoing this surgery.
METHOD


Eighty patients were enrolled and randomly allocated into 4 groups. At the end of surgery, dexmedetomidine-soaked nasal packings were applied to three groups with a dosage of 1 μg kg -1  (D1), 2μg kg -1  (D2), 4 μg kg -1  (D4) and normal saline-soaked nasal packing (NS) was applied to a fourth group. The primary outcome was postoperative pain scores using a visual analog scale (VAS) recorded at six time points: before the surgery (T1); 2 h (T2), 8 h (T3), 24 h (T4), 48 h (T5) after surgery; and at the moment of nasal packing removal (T6). Secondary outcomes were postoperative sleep status evaluated by the Pittsburgh sleep quality index (PSQI) and subjective sleep quality value (SSQV). Factors affecting sleep, hemodynamic changes, and adverse events were also recorded.
RESULTS


Compared with the NS group, dexmedetomidine-soaked nasal packing significantly relieved postoperative pain and improved sleep quality. The effect was similar between D2 and D4, which was greater than in D1. However, D2 was associated with fewer adverse events.
CONCLUSIONS


Dexmedetomidine-soaked nasal packing not only offers effective analgesia but also improves postoperative sleep quality in patients undergoing bilateral endoscopic nasal surgery. Taking effect and adverse events into consideration, a dosage of 2μg kg -1  may be optimal.
TRIAL REGISTRATION


www.chictr.org.cn/index.aspx (ChiCTR1900025692) Retrospectively registered 5 September 2019.",2021,"Compared with the NS group, dexmedetomidine-soaked nasal packing significantly relieved postoperative pain and improved sleep quality.","['Eighty patients', 'patients undergoing this surgery', 'after nasal endoscopic surgery', 'patients undergoing bilateral endoscopic nasal surgery']","['Dexmedetomidine-soaked nasal packing', 'normal saline-soaked nasal packing (NS', 'dexmedetomidine-soaked nasal packing', 'Bilateral endoscopic nasal surgery', 'dexmedetomidine-soaked nasal packings']","['Factors affecting sleep, hemodynamic changes, and adverse events', 'postoperative pain and improved sleep quality', 'pain', 'sleep quality', 'postoperative sleep quality', 'postoperative sleep status evaluated by the Pittsburgh sleep quality index (PSQI) and subjective sleep quality value (SSQV', 'pain and sleep disturbance', 'postoperative pain scores using a visual analog scale (VAS']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}]","[{'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",80.0,0.190427,"Compared with the NS group, dexmedetomidine-soaked nasal packing significantly relieved postoperative pain and improved sleep quality.","[{'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Seventh Affiliated Hospital of Sun Yat-sen University, Shen Zhen, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Shuai', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Shantou University Medical College, 57 Changping Road, Shan Tou, 515000, China.'}, {'ForeName': 'Fudan', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'Department of ENT, The First Affiliated Hospital of Shantou University Medical College, Shan Tou, China.'}, {'ForeName': 'Jiamei', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Shantou University Medical College, 57 Changping Road, Shan Tou, 515000, China.'}, {'ForeName': 'Shaohui', 'Initials': 'S', 'LastName': 'Zhuang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Shantou University Medical College, 57 Changping Road, Shan Tou, 515000, China. doctorzsh@163.com.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-021-02342-y']
600,33731847,Safety and efficacy of the BRAF inhibitor dabrafenib in relapsed or refractory hairy cell leukemia: a pilot phase-2 clinical trial.,,2021,,['relapsed or refractory hairy cell leukemia'],['BRAF inhibitor dabrafenib'],['Safety and efficacy'],"[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0023443', 'cui_str': 'Hairy cell leukemia'}]","[{'cui': 'C3838813', 'cui_str': 'B-Raf inhibitor'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.254516,,"[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Tiacci', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy. enrico.tiacci@unipg.it.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'De Carolis', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Simonetti', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Merluzzi', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bennati', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy.'}, {'ForeName': 'Vincenzo Maria', 'Initials': 'VM', 'LastName': 'Perriello', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Pucciarini', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Santi', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Venanzi', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Pettirossi', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Schiavoni', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Tasselli', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ascani', 'Affiliation': 'Anatomic Pathology, University of Perugia and Hospital of Terni, Perugia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Volpetti', 'Affiliation': 'Clinica Ematologica, Azienda Sanitaria Universitaria Integrata, Udine, Italy.'}, {'ForeName': 'Brunangelo', 'Initials': 'B', 'LastName': 'Falini', 'Affiliation': 'Hematology, University and Hospital of Perugia, Perugia, Italy. brunangelo.falini@unipg.it.'}]",Leukemia,['10.1038/s41375-021-01210-8']
601,33733720,Ultrasound-guided perineural vs. peritendinous corticosteroid injections in carpal tunnel syndrome: a randomized controlled trial.,"BACKGROUND


Corticosteroid injections are proven to be effective in the management of carpal tunnel syndrome (CTS); however, the optimal injection site still remains unclear.
AIM


The aim of this study is to compare the efficacy of perineural vs. peritendinous target sites for corticosteroid injection in CTS.
DESIGN


A randomized, single-blind, controlled trial.
SETTING


Outpatients, tertiary care center.
POPULATION


Forty-six patients were equally randomized into two intervention groups as group A (18 female and five male patients; mean age: 50.0±15.9 years; mean symptom duration: 5.9±3.3 months) and group B (19 female, four male patients; mean age: 54.3±15.0 years; mean symptom duration: 5.9±4.7 months).
METHODS


Methylprednisolone acetate (40 mg) and 1 mL of 1% trimecaine hydrochloride was injected next to the median nerve (group A) or among flexor tendons away from the nerve (group B) under ultrasound (US) guidance. The visual analogue scale was used as the primary outcome measure, and the symptom severity scale and functional status scale of the Boston Carpal Tunnel Questionnaire were used as the secondary subjective outcome measures. Two-point discrimination, grip strength, cross-sectional area, and distal motor latency were assessed as objective outcome measures. The data were collected at baseline and at 2, 6 and 12 weeks after the injection.
RESULTS


Both groups showed improvement in subjective and objective measures at 2 weeks following the injection - also maintained up to 12 weeks during the follow-up (P<0.05). However, no difference was observed between the two groups (P<0.05). No serious adverse effects were observed in either group.
CONCLUSIONS


Both intervention techniques seem to be effective and safe in the conservative treatment of CTS.
CLINICAL REHABILITATION IMPACT


Based on this study results, it might be noteworthy that physicians can opt for perineural or peritendinous injections without compromising the treatment efficacy and safety. Herewith, US guidance is, for sure, necessary for performing safe and accurate injections.",2021,Both groups showed improvement in subjective and objective measures at 2 weeks following the injection - also maintained up to 12 weeks during the follow-up (p<0.05).,"['carpal tunnel syndrome', 'Forty-six patients', 'carpal tunnel syndrome (CTS', 'Outpatients, tertiary care center']","['flexor tendons away from the nerve (Group B) under ultrasound (US) guidance', 'Corticosteroid injections', 'Methylprednisolone acetate (40 mg) and 1 mL of 1% trimecaine hydrochloride', 'Ultrasound-guided perineural vs. peritendinous corticosteroid injections']","['Twopoint discrimination, grip strength, cross-sectional area, and distal motor latency', 'subjective and objective measures', 'serious adverse effects', 'symptom severity scale and functional status scale of the Boston Carpal Tunnel Questionnaire', 'visual analogue scale']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0224848', 'cui_str': 'Structure of flexor tendon'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0600901', 'cui_str': 'Methylprednisolone acetate'}, {'cui': 'C0041026', 'cui_str': 'Trimecaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}]","[{'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",46.0,0.0643453,Both groups showed improvement in subjective and objective measures at 2 weeks following the injection - also maintained up to 12 weeks during the follow-up (p<0.05).,"[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Mezian', 'Affiliation': 'Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University, General University Hospital, Prague, Czech Republic - kamal.mezian@gmail.com.'}, {'ForeName': 'Karolína', 'Initials': 'K', 'LastName': 'Sobotová', 'Affiliation': 'Department of Rehabilitation and Sports Medicine, Second Faculty of Medicine, Charles University, Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kuliha', 'Affiliation': 'Department of Neurology, Bruntál, Czech Republic.'}, {'ForeName': 'Ke-Vin', 'Initials': 'KV', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Bei-Hu Branch, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Ceé', 'Affiliation': 'Department of Neurosurgery, J.E. Purkyně University, Masaryk Hospital, Ústí nad Labem, Czech Republic.'}, {'ForeName': 'Yvona', 'Initials': 'Y', 'LastName': 'Angerová', 'Affiliation': 'Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University, General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Özçakar', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.21.06682-X']
602,33728428,Two-Year Treatment With Metformin During Puberty Does Not Preserve β-Cell Function in Youth With Obesity.,"CONTEXT


Youth-onset type 2 diabetes is a disease of pubertal onset, associated with additional burden of pubertal insulin resistance on the β-cell.
OBJECTIVE


Evaluate the impact of metformin treatment during puberty, a critical window of cardiometabolic change, on insulin sensitivity (Si) and compensatory β-cell response in youth with obesity.
SETTING


Pediatric academic hospital clinical translational research center.
PARTICIPANTS


Healthy youth in early puberty [Tanner stage (T) 2-3] with normoglycemia and obesity (n = 44).
INTERVENTION


Double-blinded placebo-control trial of metformin during puberty (until T5).
MAIN OUTCOME MEASURES


Insulin sensitivity (Si), insulin response [acute insulin response to glucose (AIRg)], and disposition index (DI), estimated from frequently sampled intravenous glucose tolerance testing; body fat (dual X-ray absorptiometry); and other laboratory parameters, collected at baseline, T4, and T5. Placebo-subtracted treatment effect was calculated using linear mixed models.
RESULTS


At T5, metformin treatment, adjusting for sex, race, and baseline value, was associated with improved BMI z-score (-0.44 ± 0.16, P = 0.02), percentage body fat (%body fat; -3.4 ± 1.2%, P = 0.06), and waist circumference (-11.3 ± 3.2cm, P = 0.003). There were no significant treatment effects at T5 on Si or secretion: Si (0.85 ± 0.87 × 10-4/min-1/μIU/mL, P = 0.34), AIRg (-259 ± 386 μIU/mL, P = 0.51), or DI (508 ± 802 × 10-4/min-1, P = 0.53). High baseline DI predicted longitudinal decline in DI.
CONCLUSIONS


Two years of metformin treatment in obese youth during puberty improved BMI and body fat, but not Si or β-cell function. Of note, high DI in early puberty may be predictive of later decline in DI. Further studies are needed to develop strategies for preservation of β-cell function in youth at risk for type 2 diabetes.",2021,There were no significant treatment effects at T5 on insulin sensitivity or secretion:,"['youth at risk for T2D', 'youth with obesity', 'Pediatric academic hospital clinical translational research center', 'Healthy youth in early puberty (Tanner stage 2-3, T2-3) with normoglycemia and obesity (n=44']","['metformin', 'Placebo', 'placebo-control trial of metformin']","['waist circumference', 'Si', 'β-cell function', 'BMI and body fat, but not Si or β-cell function', 'Si, insulin response (acute insulin response to glucose, AIRg), and disposition index (DI), estimated from frequently-sampled intravenous glucose tolerance testing, body fat (dual x-ray absorptiometry', 'BMIz', 'insulin sensitivity or secretion', 'insulin sensitivity (Si) and compensatory β-cell response', 'body fat']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3494163', 'cui_str': 'Translational Research'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034013', 'cui_str': 'Precocious puberty'}, {'cui': 'C0335730', 'cui_str': 'Tanner'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021911', 'cui_str': 'Intravenous Glucose Tolerance'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.287209,There were no significant treatment effects at T5 on insulin sensitivity or secretion:,"[{'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Kelsey', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Aurora, CO, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Hilkin', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Aurora, CO, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pyle', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Aurora, CO, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Severn', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Aurora, CO, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Utzschneider', 'Affiliation': 'VA Puget Sound Health Care System, Seattle, WA, USA.'}, {'ForeName': 'Rachael E', 'Initials': 'RE', 'LastName': 'Van Pelt', 'Affiliation': 'University of Colorado School of Medicine, Department of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Zeitler', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Aurora, CO, USA.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Aurora, CO, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab170']
603,33709238,"Chinese Medicine Involving Triple Rehabilitation Therapy for Knee Osteoarthritis in 696 Outpatients: A Multi-Center, Randomized Controlled Trial.","OBJECTIVE


To determine the effects of Chinese medicine (CM) involving triple rehabilitation therapy on the progression of knee osteoarthritis (KOA).
METHODS


A total of 722 patients recruited from 38 community health service centers located in China from March 2013 to March 2017 were randomly divided into treatment and control groups equally, using a cluster randomization design. Health education combined with CM involving triple rehabilitation therapy for KOA (electro-acupuncture, Chinese medicinal herb fumigating-washing, and traditional exercises) was administered in the treatment group while conventional rehabilitation therapy (physical factor therapy, joint movement training, and muscle strength training) was administered in the control group. Patients with a visual analog scale (VAS) scores ≽4 were treated with dispersible meloxicam tablets (7.5 mg, once daily). The Lequesne index scores, VAS scores, range of motion (ROM), lower limb muscle strength, knee joint circumference, quantitative scores of KOA symptoms, and the short-form 36 item health survey questionnaire (SF-36) scores were measured for each patient at 5 checkpoints (before treatment, at the 2nd week and the 4th week during the 4-week treatment period, at 1 month and 3 months after end of treatment), and adverse reactions were observed also.
RESULTS


A total of 696 patients completed the entire process, with 351 in the treatment group and 345 in the control group. At all treatment checkpoints, the treatment group demonstrated better outcomes than the control group with regard to the total Lequesne index scores, effective rate and improvement rate of the total Lequesne index scores, VAS scores, lower limb muscle strength, knee circumference, quantitative scores of KOA symptoms, and SF-36 scores as well (P<0.05 or P<0.01). No adverse reactions were encountered in this study.
CONCLUSIONS


CM involving triple rehabilitation therapy can alleviate KOA-related pain and swelling, improve lower limb muscle strength, promote flexion and activity of the knee and improve the quality of life in patients undergoing KOA. It is suitable for patients with early or mid-stage KOA. (Registration No. ChiCTR-TRC-12002538).",2021,"At all treatment checkpoints, the treatment group demonstrated better outcomes than the control group with regard to the total Lequesne index scores, effective rate and improvement rate of the total Lequesne index scores, VAS scores, lower limb muscle strength, knee circumference, quantitative scores of KOA symptoms, and SF-36 scores as well (P<0.05 or P<0.01).","['696 Outpatients', 'patients undergoing KOA', '696 patients completed the entire process, with 351 in the treatment group and 345 in the control group', 'Patients with a visual analog scale (VAS) scores ≽4 were treated with', 'patients with early or mid-stage KOA', '722 patients recruited from 38 community health service centers located in China from March 2013 to March 2017']","['conventional rehabilitation therapy (physical factor therapy, joint movement training, and muscle strength training', 'Triple Rehabilitation Therapy ', 'dispersible meloxicam tablets', 'Chinese medicine (CM', 'Chinese Medicine', 'triple rehabilitation therapy ', 'KOA (electro-acupuncture, Chinese medicinal herb fumigating-washing, and traditional exercises']","['quality of life', 'adverse reactions', 'total Lequesne index scores, effective rate and improvement rate of the total Lequesne index scores, VAS scores, lower limb muscle strength, knee circumference, quantitative scores of KOA symptoms, and SF-36 scores', 'Lequesne index scores, VAS scores, range of motion (ROM), lower limb muscle strength, knee joint circumference, quantitative scores of KOA symptoms, and the short-form 36 item health survey questionnaire (SF-36) scores']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009472', 'cui_str': 'Community health services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0203967', 'cui_str': 'Joint movement training'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C1246814', 'cui_str': 'meloxicam Oral Tablet'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C4274983', 'cui_str': 'Knee joint circumference'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",722.0,0.0167763,"At all treatment checkpoints, the treatment group demonstrated better outcomes than the control group with regard to the total Lequesne index scores, effective rate and improvement rate of the total Lequesne index scores, VAS scores, lower limb muscle strength, knee circumference, quantitative scores of KOA symptoms, and SF-36 scores as well (P<0.05 or P<0.01).","[{'ForeName': 'Jie-Mei', 'Initials': 'JM', 'LastName': 'Guo', 'Affiliation': 'Department of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Tang-Yan', 'Initials': 'TY', 'LastName': 'Cai', 'Affiliation': 'Department of Clinical Medicine, Fujian Health College, Fuzhou, 350101, China.'}, {'ForeName': 'Jian-Hui', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Bao-Lin', 'Initials': 'BL', 'LastName': 'Li', 'Affiliation': 'Department of Traditional Chinese Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'Department of Traditional Chinese Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Xing-Quan', 'Initials': 'XQ', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation, Fujian Tingzhou Hospital, Longyan, Fujian Province, 366300, China.'}, {'ForeName': 'Ya-Ju', 'Initials': 'YJ', 'LastName': 'Zhu', 'Affiliation': 'Department of Emergency, Xiaogan Chinese Medicine Hospital, Xiaogan, Hubei Province, 432100, China.'}, {'ForeName': 'Yi-Qiang', 'Initials': 'YQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Fuzhou First Hospital, Fuzhou, 350009, China.'}, {'ForeName': 'Shao-Qing', 'Initials': 'SQ', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'You-Xin', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China. suyouxin777@hotmail.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-3488-6']
604,33735416,A double blind randomized controlled trial investigating efficacy and safety of varenicline for smoking cessation in patients with type 2 diabetes: study protocol.,"Reducing exposure to cigarette smoke is an imperative for public health and for diabetic patients. Patients with diabetes who continue to smoke face challenges at quitting and the delivery of effective smoking cessation interventions is a major unmet need. The high-affinity α4β2 nicotinic acetylcholine receptor partial agonist varenicline in combination with counseling is effective for smoking cessation, but evidence in patients with diabetes is limited. A clinical trial of varenicline targeted specifically at smokers with T2DM is warranted. This randomized, double blind, placebo-controlled trial will be the first study to test efficacy and safety of varenicline in smokers with type 2 diabetes mellitus (T2DM) over the course of 52 weeks. We hypothesize that varenicline treatment (1 mg BID, administered for 12 weeks) would increase quit rates, maintain smoking abstinence up to 1 year after treatment, and be well-tolerated in T2DM smokers intending to quit. Efficacy end points will include carbon monoxide-confirmed continuous abstinence rate (CAR) and 7-day point prevalence of abstinence. The results of this RCT will help inform medical/health authorities and physicians worldwide whether an optimally varenicline-treated cohort of T2DM patients who smoke will experience significant success rates, without significant side effects.Trial registration NCT01387425 ( https://clinicaltrials.gov/ct2/show/NCT01387425 ).",2021,"The high-affinity α4β2 nicotinic acetylcholine receptor partial agonist varenicline in combination with counseling is effective for smoking cessation, but evidence in patients with diabetes is limited.","['patients with diabetes', 'diabetic patients', 'patients with type 2 diabetes', 'smokers with type 2 diabetes mellitus (T2DM) over the course of 52\xa0weeks', 'Patients with diabetes']","['placebo', 'varenicline']","['quit rates, maintain smoking abstinence', 'efficacy and safety', 'carbon monoxide-confirmed continuous abstinence rate (CAR) and 7-day point prevalence of abstinence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.29725,"The high-affinity α4β2 nicotinic acetylcholine receptor partial agonist varenicline in combination with counseling is effective for smoking cessation, but evidence in patients with diabetes is limited.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Russo', 'Affiliation': 'Ambulatorio Di Diabetologia, UOC Medicina Interna E D\'Urgenza, Policlinico Universitario, AOU ""Policlinico-V. Emanuele"", Catania, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Caponnetto', 'Affiliation': 'Centro Per La Prevenzione E Cura del Tabagismo (CPCT), Azienda Ospedaliero-Universitaria ""Policlinico-V.Emanuele"" Dell\'Università Di Catania, Via S. Sofia 78, 95123, Catania, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cibella', 'Affiliation': 'Institute for Biomedical Research and Innovation, National Research Council of Italy, Palermo, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maglia', 'Affiliation': 'Centro Per La Prevenzione E Cura del Tabagismo (CPCT), Azienda Ospedaliero-Universitaria ""Policlinico-V.Emanuele"" Dell\'Università Di Catania, Via S. Sofia 78, 95123, Catania, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alamo', 'Affiliation': 'Centro Diabetologico - UOC Andrologia Ed Endocrinologia, Policlinico Universitario, AOU ""Policlinico-V. Emanuele"", Catania, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Campagna', 'Affiliation': 'Ambulatorio Di Diabetologia, UOC Medicina Interna E D\'Urgenza, Policlinico Universitario, AOU ""Policlinico-V. Emanuele"", Catania, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Frittitta', 'Affiliation': ""Centro Per Il Diabete E L'Obesità - UOC Endocrinologia, Ospedale Garibaldi Nesima, ARNAS Garibaldi, Catania, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Di Mauro', 'Affiliation': 'Center of Excellence for the Acceleration of HArm Reduction (CoEHAR), Dipartimento Di Medicina Clinica E Sperimentale, Università Di Catania, Catania, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leotta', 'Affiliation': 'Ambulatorio Di Diabetologia - UOC Geriatria, Ospedale Cannizzaro, Catania, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mondati', 'Affiliation': 'Center of Excellence for the Acceleration of HArm Reduction (CoEHAR), Dipartimento Di Medicina Clinica E Sperimentale, Università Di Catania, Catania, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Krysiński', 'Affiliation': 'Mossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Polosa', 'Affiliation': 'Ambulatorio Di Diabetologia, UOC Medicina Interna E D\'Urgenza, Policlinico Universitario, AOU ""Policlinico-V. Emanuele"", Catania, Italy. polosa@unict.it.'}]",Internal and emergency medicine,['10.1007/s11739-021-02684-1']
605,33734167,Pharmacokinetic Profile of the Asenapine Transdermal System (HP-3070).,"PURPOSE/BACKGROUND


The asenapine transdermal system (HP-3070) is the first antipsychotic patch approved in the United States for treatment of adults with schizophrenia.
METHODS/PROCEDURES


Three phase 1, open-label, randomized studies characterized the pharmacokinetic (PK) profile of HP-3070 by assessing its relative bioavailability compared with sublingual asenapine, its single-/multiple-dose PK and dose proportionality, and the effects of application site, ethnicity, and external heat on bioavailability. Two studies were conducted in healthy subjects, and 1 was conducted in adults with schizophrenia.
FINDINGS/RESULTS


During single HP-3070 administration, asenapine concentrations increased gradually over approximately 12 hours and remained steady until the patch was removed 24 hours after application. Asenapine area under the curve values at HP-3070 3.8 and 7.6 mg/24 hours doses were similar to those for sublingual asenapine 5 and 10 mg twice-daily doses, respectively, whereas peak exposure (maximum observed plasma concentration) was significantly lower. During daily application of HP-3070, steady-state PK was reached within approximately 72 hours after initiating daily dosing and was characterized by peak-to-trough asenapine plasma concentration ratio of approximately 1.5. HP-3070 PK was dose proportional in the dose range studied, not affected by administration site, and similar across the studied ethnic groups. Application of external heat increased the rate of asenapine absorption (time to reach maximum observed plasma concentration) but did not significantly affect peak and total exposure.
IMPLICATIONS/CONCLUSIONS


HP-3070 exhibited a dose-dependent PK profile unaffected by site of administration or ethnicity. HP-3070 showed a predictable absorption profile with limited variability, with an area under the curve similar to that of sublingual asenapine. Based on these PK metrics, HP-3070 steadily delivers asenapine with lower peaks and troughs than sublingual administration of asenapine.",2021,"HP-3070 PK was dose proportional in the dose range studied, not affected by administration site, and similar across the studied ethnic groups.","['adults with schizophrenia', 'healthy subjects, and 1 was conducted in adults with schizophrenia']","['Asenapine Transdermal System (HP-3070', 'HP-3070']","['asenapine concentrations', 'Asenapine area under the curve values', 'rate of asenapine absorption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C2000088', 'cui_str': 'Asenapine'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}]","[{'cui': 'C2000088', 'cui_str': 'Asenapine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",,0.068597,"HP-3070 PK was dose proportional in the dose range studied, not affected by administration site, and similar across the studied ethnic groups.","[{'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'From Product Development, Noven Pharmaceuticals, Inc, Jersey City, NJ.'}, {'ForeName': 'Mariacristina', 'Initials': 'M', 'LastName': 'Castelli', 'Affiliation': 'From Product Development, Noven Pharmaceuticals, Inc, Jersey City, NJ.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Komaroff', 'Affiliation': 'From Product Development, Noven Pharmaceuticals, Inc, Jersey City, NJ.'}, {'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Starling', 'Affiliation': 'From Product Development, Noven Pharmaceuticals, Inc, Jersey City, NJ.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Terahara', 'Affiliation': 'Hisamitsu Pharmaceutical Co, Inc, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Citrome', 'Affiliation': 'Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001383']
606,33734782,Generalizing treatment outcomes to externalizing behaviors for Latino/a adolescents with substance use disorders: A secondary analysis.,"OBJECTIVE


Substance use treatment for adolescents may decrease not only substance use, but also other related outcomes such as externalizing behaviors. Although positively correlated to substance use in youth, externalizing behaviors are not commonly measured as outcomes in the context of substance use treatment. This study seeks to generalize the outcomes of substance use treatment to externalizing behaviors in a sample of Latino/a adolescents who participated in a randomized clinical trial.
METHOD


Secondary data analysis was conducted using a longitudinal mixed model to test the outcomes of two versions of a cognitive-behavioral substance use treatment (i.e., standard and culturally accommodated) on externalizing behaviors. Participants were Latino/a adolescents ( N  = 70) diagnosed with a substance use disorder randomized into one of the two study conditions.
RESULTS


The results indicated that Latino/a adolescents in both treatment conditions significantly decreased in self-reported externalizing behaviors from pretreatment to 12-months posttreatment.
CONCLUSIONS


Implications from this study suggest that participation in substance use treatment for Latino/a adolescents may also generalize to other outcomes such as externalizing behaviors. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"OBJECTIVE


Substance use treatment for adolescents may decrease not only substance use, but also other related outcomes such as externalizing behaviors.","['Participants were Latino/a adolescents ( N  = 70) diagnosed with a substance use disorder randomized into one of the two study conditions', 'Latino/a adolescents with substance use disorders', 'externalizing behaviors in a sample of Latino/a adolescents who participated in a randomized clinical trial']","['cognitive-behavioral substance use treatment (i.e., standard and culturally accommodated']","['externalizing behaviors', 'self-reported externalizing behaviors']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150359', 'cui_str': 'Substance use therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.0856897,"OBJECTIVE


Substance use treatment for adolescents may decrease not only substance use, but also other related outcomes such as externalizing behaviors.","[{'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Burrow-Sánchez', 'Affiliation': 'Department of Educational Psychology.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Totsky', 'Affiliation': 'Department of Educational Psychology.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Ratcliff', 'Affiliation': 'Department of Educational Psychology.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Corrales', 'Affiliation': 'Department of Educational Psychology.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000713']
607,33739123,Local Passive Heat for the Treatment of Hypertension in Autonomic Failure.,"Background Supine hypertension affects a majority of patients with autonomic failure; it is associated with end-organ damage and can worsen daytime orthostatic hypotension by inducing pressure diuresis and volume loss during the night. Because sympathetic activation prevents blood pressure (BP) from falling in healthy subjects exposed to heat, we hypothesized that passive heat had a BP-lowering effect in patients with autonomic failure and could be used to treat their supine hypertension. Methods and Results In Protocol 1 (n=22), the acute effects of local heat (40-42°C applied with a heating pad placed over the abdomen for 2 hours) versus sham control were assessed in a randomized crossover fashion. Heat acutely decreased systolic BP by -19±4 mm Hg (versus 3±4 with sham,  P <0.001) owing to decreases in stroke volume (-18±5% versus -4±4%,  P =0.013 ) and cardiac output (-15±5% versus -2±4%,  P =0.013). In Protocol 2 (proof-of-concept overnight study; n=12), we compared the effects of local heat (38°C applied with a water-perfused heating pad placed under the torso from 10 pm to 6 am) versus placebo pill. Heat decreased nighttime systolic BP (maximal change -28±6 versus -2±6 mm Hg,  P <0.001). BP returned to baseline by 8 am. The nocturnal systolic BP decrease correlated with a decrease in urinary volume ( r =0.57,  P =0.072) and an improvement in the morning upright systolic BP ( r =-0.76,  P =0.007). Conclusions Local heat therapy effectively lowered overnight BP in patients with autonomic failure and supine hypertension and offers a novel approach to treat this condition. Future studies are needed to assess the long-term safety and efficacy in improving nighttime fluid loss and daytime orthostatic hypotension. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02417415 and NCT03042988.",2021,"Heat acutely decreased systolic BP by -19±4 mm Hg (versus 3±4 with sham,  P <0.001) owing to decreases in stroke volume (-18±5% versus -4±4%,  P =0.013 ) and cardiac output (-15±5% versus -2±4%,  P =0.013).","['healthy subjects', 'patients with autonomic failure and supine hypertension', 'Hypertension in Autonomic Failure', 'patients with autonomic failure']","['local heat (40-42°C applied with a heating pad placed over the abdomen for 2\xa0hours) versus sham control', 'local heat (38°C applied with a water-perfused heating pad placed under the torso from 10\xa0pm to 6\xa0am) versus placebo pill', 'Local Passive Heat']","['stroke volume', 'BP', 'nocturnal systolic BP', 'blood pressure (BP', 'cardiac output', 'urinary volume', 'nighttime systolic BP', 'overnight BP', 'morning upright systolic BP', 'systolic BP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393911', 'cui_str': 'Pure autonomic failure'}, {'cui': 'C4076686', 'cui_str': 'Supine hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0332170', 'cui_str': 'Morning'}]",,0.0601881,"Heat acutely decreased systolic BP by -19±4 mm Hg (versus 3±4 with sham,  P <0.001) owing to decreases in stroke volume (-18±5% versus -4±4%,  P =0.013 ) and cardiac output (-15±5% versus -2±4%,  P =0.013).","[{'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Okamoto', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Celedonio', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Smith', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Gamboa', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Cyndya A', 'Initials': 'CA', 'LastName': 'Shibao', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Diedrich', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Sachin Y', 'Initials': 'SY', 'LastName': 'Paranjape', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Bonnie K', 'Initials': 'BK', 'LastName': 'Black', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'James A S', 'Initials': 'JAS', 'LastName': 'Muldowney', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Peltier', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Habermann', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Crandall', 'Affiliation': 'Institute for Exercise and Environmental Medicine Texas Health Presbyterian Hospital and UT Southwestern Medical Center Dallas TX.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Biaggioni', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University Medical Center Nashville TN.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.018979']
608,33730345,Continuous positive airway pressure acutely increases exercise duration in children with severe therapy-resistant asthma: a randomized crossover trial.,"BACKGROUND


Lower exercise tolerance is an important component of asthma and the possible effects of non-invasive ventilation on exercise capacity in individuals with severe therapy-resistant asthma (STRA) are unknown. This study aimed to evaluate the immediate effect of continuous positive airway pressure (CPAP) on exercise tolerance in children with STRA.
METHODS


We performed a controlled, randomized, crossover clinical trial including subjects aged 6 to 18 years old diagnosed with STRA. Clinical, anthropometric and lung function data were collected. The participants in the intervention group (IG) used CPAP (PEEP 10cmH 2 O and FiO 2  0.21) for a period of 40 min. Subjects in the control group (CG) used CPAP with minimum PEEP at 1 cmH 2 0 also for 40 min. Afterwards, subjects from both groups underwent cardiopulmonary exercise testing (CPET). After a 15-day washout period, on a subsequent visit, subjects participated in the opposite group to the initial one.
RESULTS


Thirteen subjects with a mean age of 12.30 ± 1.7 years were included. The variables of peak expiratory flow (PEF) and forced expiratory volume in the first second (FEV 1 ) before using CPAP and after performing CPET did not show significant differences. Regarding CPET results, there was no significant difference (P = 0.59) between groups at peak exercise for oxygen consumption-VO 2  (CG: 33.4 ± 6.3 and IG: 34.5 ± 5.9, mL kg -1  min -1 ). However, the IG (12.4 ± 2.1) presented a total test time (min) significantly (P = 0.01) longer than the CG (11.5 ± 1.3).
CONCLUSION


The results suggest that the use of CPAP before physical exercise increases exercise duration in children and adolescents with STRA.",2021,"Regarding CPET results, there was no significant difference (P = 0.59) between groups at peak exercise for oxygen consumption-VO 2  (CG: 33.4 ± 6.3 and IG: 34.5 ± 5.9, mL kg","['children and adolescents with STRA', 'Thirteen subjects with a mean age of 12.30\u2009±\u20091.7\xa0years were included', 'children with STRA', 'subjects aged 6 to 18\xa0years old diagnosed with STRA', 'children with severe therapy-resistant asthma', 'individuals with severe therapy-resistant asthma (STRA']","['Continuous positive airway pressure acutely increases exercise duration', 'CPAP before physical exercise', 'cardiopulmonary exercise testing (CPET', 'continuous positive airway pressure (CPAP', 'CPAP (PEEP 10cmH']","['total test time (min) significantly ', 'peak expiratory flow (PEF) and forced expiratory volume in the first second (FEV 1 ', 'exercise duration', 'exercise tolerance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0055954', 'cui_str': 'Clostridium perfringens epsilon toxin'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}]",13.0,0.0120933,"Regarding CPET results, there was no significant difference (P = 0.59) between groups at peak exercise for oxygen consumption-VO 2  (CG: 33.4 ± 6.3 and IG: 34.5 ± 5.9, mL kg","[{'ForeName': 'Cláudia Silva', 'Initials': 'CS', 'LastName': 'Schindel', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Centro Infant, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Av. Ipiranga, 6690, 2º andar, Porto Alegre, RS, CEP 90610-000, Brazil.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Schiwe', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Centro Infant, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Av. Ipiranga, 6690, 2º andar, Porto Alegre, RS, CEP 90610-000, Brazil.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Heinzmann-Filho', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Centro Infant, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Av. Ipiranga, 6690, 2º andar, Porto Alegre, RS, CEP 90610-000, Brazil.'}, {'ForeName': 'Natália Evangelista', 'Initials': 'NE', 'LastName': 'Campos', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Centro Infant, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Av. Ipiranga, 6690, 2º andar, Porto Alegre, RS, CEP 90610-000, Brazil.'}, {'ForeName': 'Paulo Márcio', 'Initials': 'PM', 'LastName': 'Pitrez', 'Affiliation': 'Hospital Moinhos de Vento, Porto Alegre, Brazil and Centro Infant, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.'}, {'ForeName': 'Márcio Vinícius Fagundes', 'Initials': 'MVF', 'LastName': 'Donadio', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Centro Infant, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Av. Ipiranga, 6690, 2º andar, Porto Alegre, RS, CEP 90610-000, Brazil. mdonadio@pucrs.br.'}]",World journal of pediatrics : WJP,['10.1007/s12519-021-00425-0']
609,33713629,Teaching point-of-care transfontanellar ultrasound for pediatricians and medical students.,"OBJECTIVES


The authors aim to evaluate the ""point-of-care"" transfontanellar ultrasound (TU) as an extension to pediatric physical examination and suggest a TU teaching protocol.
METHODS


The students were randomly divided into two groups, group A (12 participants) and group B (15 participants). The first group only received theoretical training, while the second group received theoretical and practical training. A third group, group C, included 15 pediatricians and interns who also received theoretical and practical training. All the participants underwent multiple-choice testing before and after a four-hour short course on TU. Six months later, another evaluation was performed to analyze the retained knowledge. Furthermore, a questionnaire based on the Likert scale was administered to evaluate satisfaction.
RESULTS


The cognitive evaluation (maximum score=10 points) before and after training increased in group A from 4,0±1,04 to 7,5±1,2 (p<0.001) and, 6 months later, to 6,5±1,16 (p<0.003); in group B from 3,8±1,24 to 8,8±1,01 (p<0.001) and, 6 months later, to 8,46±0,91 (p<0.001); and in group C from 6,0±0,75 to 9,0±0,75 (p<0.001) and, 6 months later, to 8,8±0,77 (p<0.001). The average satisfaction estimated by the Likert scale was over 80% for all questions.
CONCLUSION


Cognitive assessment before and after classes and training reveals progress in learning, with knowledge retention in 6 months. Theoretical-practical courses are well accepted.",2021,"The cognitive evaluation (maximum score=10 points) before and after training increased in group A from 4,0±1,04 to 7,5±1,2 (p<0.001) and, 6 months later, to 6,5±1,16 (p<0.003); in group B from 3,8±1,24 to 8,8±1,01 (p<0.001) and, 6 months later, to 8,46±0,91 (p<0.001); and in group C from 6,0±0,75 to 9,0±0,75 (p<0.001) and, 6 months later, to 8,8±0,77 (p<0.001).",['pediatricians and medical students'],"['15 pediatricians and interns who also received theoretical and practical training', 'Teaching point-of-care transfontanellar ultrasound', 'care"" transfontanellar ultrasound (TU', 'theoretical training, while the second group received theoretical and practical training']",['average satisfaction'],"[{'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0236203,"The cognitive evaluation (maximum score=10 points) before and after training increased in group A from 4,0±1,04 to 7,5±1,2 (p<0.001) and, 6 months later, to 6,5±1,16 (p<0.003); in group B from 3,8±1,24 to 8,8±1,01 (p<0.001) and, 6 months later, to 8,46±0,91 (p<0.001); and in group C from 6,0±0,75 to 9,0±0,75 (p<0.001) and, 6 months later, to 8,8±0,77 (p<0.001).","[{'ForeName': 'Gustavo Bittencourt', 'Initials': 'GB', 'LastName': 'Camilo', 'Affiliation': 'Universidade Federal de Juiz de Fora (UFJF), Programa de Pós-graduação em Saúde Brasileira, Juiz de Fora, MG, Brazil; Universidade do Estado do Rio de Janeiro (UERJ), Departamento de Pneumologia, Programa de Pós-graduação em Ciências Médica, Rio de Janeiro, RJ, Brazil. Electronic address: gustavoscamilo@gmail.com.'}, {'ForeName': 'Gabriela Cumani', 'Initials': 'GC', 'LastName': 'Toledo', 'Affiliation': 'Universidade Federal de Juiz de Fora (UFJF), Programa de Pós-graduação em Saúde Brasileira, Juiz de Fora, MG, Brazil; Faculdade de Ciências Médicas e da Saúde de Juiz de Fora (Suprema), Departamento de Radiologia, Juiz de Fora, MG, Brazil; Hospital e Maternidade Teresinha de Jesus (HMTJ), Departamento de Radiologia, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Hebert', 'Initials': 'H', 'LastName': 'Olímpio', 'Affiliation': 'Universidade do Estado do Rio de Janeiro (UERJ), Departamento de Pneumologia, Programa de Pós-graduação em Ciências Médica, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Eleusa Nogueira', 'Initials': 'EN', 'LastName': 'Dias', 'Affiliation': 'Faculdade de Ciências Médicas e da Saúde de Juiz de Fora (Suprema), Departamento de Radiologia, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Bianca Lopes de', 'Initials': 'BL', 'LastName': 'Oliveira', 'Affiliation': 'Faculdade de Ciências Médicas e da Saúde de Juiz de Fora (Suprema), Departamento de Radiologia, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Júlia Perches', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Faculdade de Ciências Médicas e da Saúde de Juiz de Fora (Suprema), Departamento de Radiologia, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Pedro de Freitas Batista', 'Initials': 'PFB', 'LastName': 'Mendes', 'Affiliation': 'Universidade Federal de Juiz de Fora (UFJF), Departamento de Nefrologia, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Marcus Gomes', 'Initials': 'MG', 'LastName': 'Bastos', 'Affiliation': 'Universidade Federal de Juiz de Fora (UFJF), Programa de Pós-graduação em Saúde Brasileira, Juiz de Fora, MG, Brazil; Universidade Federal de Juiz de Fora (UFJF), Departamento de Nefrologia, Juiz de Fora, MG, Brazil.'}]",Jornal de pediatria,['10.1016/j.jped.2021.01.006']
610,33739848,Comparison of Radiation With or Without Concurrent Trastuzumab for HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy: A Phase III Clinical Trial.,"PURPOSE


Preclinical studies report that trastuzumab (T) can boost radiotherapy (RT) effectiveness. The primary aim of the B-43 trial was to assess the efficacy of RT alone vs concurrent RT plus T in preventing recurrence of ipsilateral breast cancer (IBTR) in women with ductal carcinoma in situ (DCIS).
PATIENTS AND METHODS


Eligibility: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, DCIS resected by lumpectomy, known estrogen receptor (ER) and/or progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2) status by centralized testing. Whole-breast RT was given concurrently with T. Stratification was by menopausal status, adjuvant endocrine therapy plan, and nuclear grade. Definitive intent-to-treat primary analysis was to be conducted when either 163 IBTR events occurred or all accrued patients were on study ≥ 5 years.
RESULTS


There were 2,014 participants who were randomly assigned. Median follow-up time as of December 31, 2019, was 79.2 months. At primary definitive analysis, 114 IBTR events occurred: RT arm, 63 and RT plus T arm, 51 (hazard ratio [HR], 0.81; 95% CI, 0.56 to 1.17;  P  value = .26). There were 34 who were invasive: RT arm, 18 and RT plus T arm, 20 (HR, 1.11; 95% CI, 0.59 to 2.10;  P  value = .71). Seventy-six were DCIS: RT arm, 45 and RT plus T arm, 31 (HR, 0.68; 95% CI, 0.43 to 1.08;  P  value = .11). Annual IBTR event rates were: RT arm, 0.99%/y and RT plus T arm, 0.79%/y. The study did not reach the 163 protocol-specified events, so the definitive analysis was triggered by all patients having been on study for ≥ 5 years.
CONCLUSION


Addition of T to RT did not achieve the objective of 36% reduction in IBTR rate but did achieve a modest but statistically nonsignificant reduction of 19%. Nonetheless, this trial had negative results. Further exploration of RT plus T is needed in HER2-positive DCIS before its routine delivery in patients with DCIS resected by lumpectomy.",2021,"RT arm, 45 and RT plus T arm, 31 (HR, 0.68; 95% CI, 0.43 to 1.08;  P  value = .11).","['Eligibility: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', '2,014 participants who were randomly assigned', 'women with ductal carcinoma in situ (DCIS', 'HER2-Positive Ductal Carcinoma', 'patients with DCIS resected by lumpectomy', 'Seventy-six were DCIS']","['Radiation With or Without Concurrent Trastuzumab', 'RT alone vs concurrent RT plus T', 'Lumpectomy', 'trastuzumab (T']","['DCIS resected by lumpectomy, known estrogen receptor (ER', 'IBTR rate', 'Annual IBTR event rates', 'recurrence of ipsilateral breast cancer (IBTR']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}, {'cui': 'C4319622', 'cui_str': '76'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}]","[{'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",34.0,0.162008,"RT arm, 45 and RT plus T arm, 31 (HR, 0.68; 95% CI, 0.43 to 1.08;  P  value = .11).","[{'ForeName': 'Melody A', 'Initials': 'MA', 'LastName': 'Cobleigh', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Anderson', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Kalliopi P', 'Initials': 'KP', 'LastName': 'Siziopikou', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Arthur', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Rabinovitch', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Julian', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Parda', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Seaward', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Carter', 'Affiliation': 'Rocky Mountain Cancer Centers, Aurora, CO.'}, {'ForeName': 'Janice A', 'Initials': 'JA', 'LastName': 'Lyons', 'Affiliation': 'University Hospitals Seidman Cancer Center, Cleveland, OH.'}, {'ForeName': 'Melissa S', 'Initials': 'MS', 'LastName': 'Dillmon', 'Affiliation': 'Harbin Clinic, Rome, GA.'}, {'ForeName': 'Gustav C', 'Initials': 'GC', 'LastName': 'Magrinat', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Vivek S', 'Initials': 'VS', 'LastName': 'Kavadi', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Zibelli', 'Affiliation': 'Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Tiriveedhi', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Hill', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Marianne K', 'Initials': 'MK', 'LastName': 'Melnik', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Sushil', 'Initials': 'S', 'LastName': 'Beriwal', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02824']
611,33742282,Improving the mother-infant relationship following postnatal depression: a randomised controlled trial of a brief intervention (HUGS).,"Postnatal depression (PND) disrupts the crucial mother-infant relationship on which optimal child development depends. However, few well-evaluated, brief mother-infant interaction interventions exist. This randomised controlled trial (RCT) aimed to evaluate the effect of a 4-session, group-based mother-infant interaction intervention ('HUGS'), compared to a control playgroup, both following cognitive-behavioural therapy for PND, on mother-infant relationships and early child development. It was hypothesised that dyads receiving the HUGS intervention would show larger improvements than control dyads. Mothers (n = 77; M age = 32 years) diagnosed with major or minor depressive disorder using the Structured Clinical Interview for the DSM-IV participated with their infants (<12 months). Primary outcomes were observed mother-infant interactions using the Parent Child Early Relational Assessment (ERA) and maternal parenting stress using the Parenting Stress Index (PSI). Data were collected at baseline, post-PND treatment, post-HUGS intervention and 6-month post-HUGS follow-up. Seventy-four percent of HUGS dyads attended at least half of the HUGS sessions (≥2). Significant group differences emerged at the 6-month follow-up (but were not significant immediately post-HUGS). At 6-month follow-up, HUGS dyads showed significantly improved parental positive affective involvement and verbalisation (ERA; F 1, 47  = 4.96, p = .03, η p 2  = .10) and less impaired bonding (F 1, 45  = 4.55, p = .04, η p 2  = .09) than control dyads. No differences were found on the PSI or on child development outcomes. Both groups improved substantially (around 30 points) on the PSI following PND treatment, so that average scores were below the clinically significant threshold when beginning HUGS and the control playgroup. Findings suggest that incorporating HUGS intervention following PND treatment is effective for improving mother-infant relationships. A longer-term follow-up and larger sample size may be needed for improved mother-infant relationships to show an impact on observable child developmental outcomes. Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612001110875).",2021,Significant group differences emerged at the 6-month follow-up (but were not significant immediately post-HUGS).,['Mothers (n\u2009=\u200977; M age\u2009=\u200932\xa0years) diagnosed with major or minor depressive disorder using the Structured Clinical Interview for the DSM-IV participated with their infants (<12\xa0months'],"[""4-session, group-based mother-infant interaction intervention ('HUGS"", 'brief intervention (HUGS', 'HUGS intervention']","['parental positive affective involvement and verbalisation', 'Postnatal depression (PND', 'observed mother-infant interactions using the Parent Child Early Relational Assessment (ERA) and maternal parenting stress using the Parenting Stress Index (PSI']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520675', 'cui_str': 'Minor depressive disorder'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658199', 'cui_str': 'Mother-Infant Relations'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C3658199', 'cui_str': 'Mother-Infant Relations'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.120177,Significant group differences emerged at the 6-month follow-up (but were not significant immediately post-HUGS).,"[{'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Holt', 'Affiliation': 'Parent-Infant Research Institute, Austin Health, 300 Waterdale Rd, Heidelberg Heights, VIC, 3081, Australia. Charlene.Holt@austin.org.au.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Gentilleau', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Toulouse University Hospital (CHU de Toulouse), Toulouse, France.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Gemmill', 'Affiliation': 'Parent-Infant Research Institute, Austin Health, 300 Waterdale Rd, Heidelberg Heights, VIC, 3081, Australia.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Milgrom', 'Affiliation': 'Parent-Infant Research Institute, Austin Health, 300 Waterdale Rd, Heidelberg Heights, VIC, 3081, Australia.'}]",Archives of women's mental health,['10.1007/s00737-021-01116-5']
612,33740394,"A Phase I Randomized, Controlled, Clinical Trial of Valganciclovir in Idiopathic Pulmonary Fibrosis.","Rationale:  Human herpesviruses Epstein-Barr virus and cytomegalovirus are frequently detectable in the lungs of patients with idiopathic pulmonary fibrosis (IPF) and could contribute to disease pathogenesis.  Objectives:  With the goal of inhibiting herpesvirus replication, we tested the safety and tolerability of adding valganciclovir to standard IPF therapy (pirfenidone).  Methods:  We performed a single-center, Phase I, double-blind, randomized, placebo-controlled trial comparing valganciclovir 900 mg daily with placebo in patients with IPF with serologic evidence of prior Epstein-Barr virus and/or cytomegalovirus infection who were tolerating full-dose pirfenidone (2,403 mg/d). Subjects were randomized to valganciclovir or placebo 2:1 for 12 weeks of active treatment with off-treatment follow-up for up to 12 months. The primary safety endpoint was the number of subjects discontinuing the study drug before completing 12 weeks of treatment.  Results:  Thirty-one subjects with IPF were randomized to valganciclovir ( n  = 20) or placebo ( n  = 11). All subjects completed assigned therapy except one subject in the valganciclovir group, who discontinued the study drug after developing a rash. The total number of adverse events was similar between study groups. In a prespecified analysis of secondary physiologic endpoints, we observed a trend toward improved forced vital capacity from randomization to Week 12 in valganciclovir-treated subjects (-10 ml; interquartile range [IQR], -65 to 70 ml) versus placebo-treated subjects (40 ml; IQR, -130 to 60 ml), which persisted through 12 months of follow-up.  Conclusions:  Valganciclovir is safe and well tolerated as an add-on therapy to pirfenidone in patients with IPF. Clinical trial registered with ClinicalTrials.gov (NCT02871401).",2021,Total adverse events were similar between study groups.,"['IPF patients with serologic evidence of prior EBV and/or CMV infection who were tolerating full-dose pirfenidone (2403 mg/day', 'Idiopathic Pulmonary Fibrosis', 'IPF patients', 'Thirty-one subjects with IPF']","['valganciclovir to standard IPF therapy (pirfenidone', 'valganciclovir or placebo', 'Valganciclovir', 'placebo', 'valganciclovir', 'valganciclovir 900 mg daily to placebo']","['forced vital capacity (FVC', 'number of subjects discontinuing study drug before completing 12 weeks of treatment', 'safety and tolerability', 'Total adverse events']","[{'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0450355', 'cui_str': '31'}]","[{'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",31.0,0.549187,Total adverse events were similar between study groups.,"[{'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Blackwell', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Hewlett', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}, {'ForeName': 'Wendi R', 'Initials': 'WR', 'LastName': 'Mason', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Del Greco', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}, {'ForeName': 'Guixiao', 'Initials': 'G', 'LastName': 'Ding', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}, {'ForeName': 'Pingsheng', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lancaster', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Loyd', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}, {'ForeName': 'Rosemarie B', 'Initials': 'RB', 'LastName': 'Dudenhofer', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Salisbury', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Kropski', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine and.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202102-108OC']
613,33706002,Supporting families of children with overweight and obesity to live healthy lifestyles: Design and rationale for the Fitline cluster randomized controlled pediatric practice-based trial.,"BACKGROUND


Over a third of preadolescent children with overweight or obesity. The American Academy of Pediatrics (AAP) recommends pediatric providers help families make changes in eating and activity to improve body mass index (BMI). However, implementation is challenging given limited time and referral sources, and family burden to access in-person weight management programs.
PURPOSE


To describe the design of a National Heart Blood and Lung Institute sponsored cluster randomized controlled pediatric-based trial evaluating the effectiveness of the Fitline pediatric practice-based referral program to reduce BMI and improve diet and physical activity in children with overweight or obesity. Comparison will be made between brief provider intervention plus referral to (1) eight weekly nutritionist-delivered coaching calls with workbook to help families make AAP-recommended lifestyle changes (Fitline-Coaching), vs. (2) the same workbook in eight mailings without coaching (Fitline-Workbook).
METHODS


Twenty practices are pair-matched and randomized to one of the two conditions; 494 parents and their children ages 8-12 with a BMI of ≥85th percentile are being recruited. The primary outcome is child BMI; secondary outcomes are child's diet and physical activity at baseline and 6- and 12-months post-baseline. Cost-effectiveness of the two interventions also will be examined.
CONCLUSION


This is the first randomized controlled trial to examine use of a centrally located telephonic coaching service to support families of children with overweight and obesity in making AAP-recommended lifestyle changes. If effective, the Fitline program will provide an innovative model for widespread dissemination, setting new standards for weight management care in pediatric practice.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03143660.",2021,This is the first randomized controlled trial to examine use of a centrally located telephonic coaching service to support families of children with overweight and obesity in making AAP-recommended lifestyle changes.,"['preadolescent children with overweight or obesity', 'children with overweight and obesity to live healthy lifestyles', 'children with overweight and obesity in making AAP-recommended lifestyle changes', 'Twenty practices are pair-matched and randomized to one of the two conditions; 494 parents and their children ages 8-12 with a BMI of ≥85th percentile are being recruited', 'children with overweight or obesity']","['Fitline pediatric practice-based referral program', 'centrally located telephonic coaching service']","[""child BMI; secondary outcomes are child's diet and physical activity"", 'Cost-effectiveness']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",494.0,0.0822427,This is the first randomized controlled trial to examine use of a centrally located telephonic coaching service to support families of children with overweight and obesity in making AAP-recommended lifestyle changes.,"[{'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Pbert', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States. Electronic address: lori.pbert@umassmed.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Druker', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bram', 'Affiliation': 'Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Olendzki', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': 'Graduate School of Nursing, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Frisard', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Waring', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Clements', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Schneider', 'Affiliation': 'Department of Psychology, Rosalind Franklin University of Medicine and Science, North Chicago, IL, United States.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Geller', 'Affiliation': 'Department of Social and Behavioral Sciences, Harvard School of Public Health, Boston, MA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106348']
614,33745107,"Transvenous phrenic nerve stimulation improves central sleep apnea, sleep quality, and quality of life regardless of prior positive airway pressure treatment.","STUDY OBJECTIVE


Positive airway pressure (PAP) therapy for central sleep apnea (CSA) is often poorly tolerated, ineffective, or contraindicated. Transvenous phrenic nerve stimulation (TPNS) offers an alternative, although its impact on previously PAP-treated patients with CSA has not been examined.
METHODS


TPNS responses among PAP-naïve and prior PAP-treated patients from the remedē ®  System Pivotal Trial were assessed. Of 151, 56 (37%) used PAP therapy before enrolling in the trial. Patients were implanted with a TPNS device and randomized to either active or deferred (control) therapy for 6 months before therapy activation. Apnea-hypopnea index (AHI) and patient-reported outcomes (PRO) were assessed at baseline, and 6 and 12 months following active therapy.
RESULTS


Patients had moderate-severe CSA at baseline, which was of greater severity and more symptomatic in the PAP-treated vs. PAP-naïve group (median AHI 52/h vs. 38, central apnea index (CAI) 32/h vs. 18, Epworth Sleepiness Scale 13 vs. 10, fatigue severity scale 5.2 vs. 4.5). Twelve months of TPNS decreased AHI to <20/h and CAI to ≤2/h. Both groups showed reductions in daytime sleepiness and fatigue, improved well-being by patient global assessment, and high therapeutic acceptance with 98% and 94% of PAP-treated and PAP-naïve patients indicating they would undergo the implant again. Stimulation produced discomfort in approximately one-third of patients, yet <5% of prior PAP-treated participants discontinued therapy.
CONCLUSION


Polysomnographic and clinical responses to TPNS were comparable in PAP-naïve and prior PAP-treated CSA patients. TPNS is a viable therapy across a broad spectrum of CSA patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT01816776; March 22, 2013.",2021,"Both groups showed reductions in daytime sleepiness and fatigue, improved well-being by patient global assessment, and high therapeutic acceptance with 98% and 94% of PAP-treated and PAP-naïve patients indicating they would undergo the implant again.","['central sleep apnea (CSA', 'TPNS responses among PAP-naïve and prior PAP-treated patients from the remedē ®  System Pivotal Trial were assessed']","['Positive airway pressure (PAP) therapy', 'PAP therapy', 'TPNS device and randomized to either active or deferred (control) therapy', 'Transvenous phrenic nerve stimulation (TPNS', 'TPNS', 'Transvenous phrenic nerve stimulation']","['discomfort', 'Apnea-hypopnea index (AHI) and patient-reported outcomes (PRO', 'moderate-severe CSA', 'central sleep apnea, sleep quality, and quality of life regardless of prior positive airway pressure treatment', 'daytime sleepiness and fatigue, improved well-being by patient global assessment, and high therapeutic acceptance', 'central apnea index']","[{'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0328586,"Both groups showed reductions in daytime sleepiness and fatigue, improved well-being by patient global assessment, and high therapeutic acceptance with 98% and 94% of PAP-treated and PAP-naïve patients indicating they would undergo the implant again.","[{'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Schwartz', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA. aschwar02@gmail.com.'}, {'ForeName': 'Lee R', 'Initials': 'LR', 'LastName': 'Goldberg', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McKane', 'Affiliation': 'Respicardia, Inc., Minnetonka, MN, USA.'}, {'ForeName': 'Timothy I', 'Initials': 'TI', 'LastName': 'Morgenthaler', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-021-02335-x']
615,33744327,"Inhaled JAK inhibitor GDC-0214 reduces exhaled nitric oxide in patients with mild asthma: A randomized, controlled, proof-of-activity trial.","BACKGROUND


The Janus kinase (JAK) pathway mediates the activity of many asthma-relevant cytokines, including IL-4 and IL-13. GDC-0214 is a potent, inhaled, small-molecule JAK inhibitor being developed for the treatment of asthma.
OBJECTIVE


We sought to determine whether GDC-0214 reduces fractional exhaled nitric oxide (Feno), a JAK1-dependent biomarker of airway inflammation, in patients with mild asthma.
METHODS


We conducted a double-blind, randomized, placebo-controlled, phase 1 proof-of-activity study in adults with mild asthma and Feno higher than 40 parts per billion (ppb). Subjects were randomized 2:1 (GDC-0214:placebo) into 4 sequential ascending-dose cohorts (1 mg once daily [QD], 4 mg QD, 15 mg QD, or 15 mg twice daily). All subjects received 4 days of blinded placebo, then 10 days of either active drug or placebo. The primary outcome was placebo-corrected percent reduction in Feno from baseline to day 14. Baseline was defined as the average Feno during the blinded placebo period. Pharmacokinetics, safety, and tolerability were also assessed.
RESULTS


Thirty-six subjects (mean age, 28 years; 54% females) were enrolled. Mean Feno at baseline across all subjects was 93 ± 43 ppb. At day 14, placebo-corrected difference in Feno was -23% (95% CI, -37.3 to -9) for 15 mg QD and -42% (95% CI, -57 to -27.4) for 15 mg twice daily. Higher plasma exposure was associated with greater Feno reduction. No dose-limiting adverse events, serious adverse events, or treatment discontinuations occurred. There were no major imbalances in adverse events or laboratory findings, or evidence of systemic JAK inhibition.
CONCLUSIONS


GDC-0214, an inhaled JAK inhibitor, caused dose-dependent reductions in Feno in mild asthma and was well tolerated without evidence of systemic toxicity.",2021,"No dose-limiting adverse events (AEs), serious AEs, or treatment discontinuations occurred.","['patients with mild asthma', 'Thirty-six subjects (mean age, 28 years; 54% female) were enrolled', 'adults with mild asthma and FeNO >40ppb']","['active drug or placebo', 'placebo', 'GDC-0214', 'Inhaled JAK inhibitor GDC-0214']","['placebo-corrected percent reduction in FeNO', 'Mean FeNO', 'Pharmacokinetics, safety, and tolerability', 'FeNO', 'exhaled nitric oxide']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3854325', 'cui_str': 'Janus kinase inhibitor'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]",,0.823161,"No dose-limiting adverse events (AEs), serious AEs, or treatment discontinuations occurred.","[{'ForeName': 'Irene E', 'Initials': 'IE', 'LastName': 'Braithwaite', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. Electronic address: irene.braithwaite@mrinz.ac.nz.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cai', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Tom', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Galanter', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Owen', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Anna G', 'Initials': 'AG', 'LastName': 'McGregor', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Eliahu', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Durk', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Hart S', 'Initials': 'HS', 'LastName': 'Dengler', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Zak', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Kenny', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Wilson', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.02.042']
616,33745697,Evaluating the effectiveness of the Imperial Femoral Intramedullary Nailing Cognitive Task Analysis (IFINCTA) tool in a real-time simulation setting (Distributed Interactive Simulation): a randomized controlled trial.,"INTRODUCTION


Working time regulations, senior led service delivery and increasing complexity of surgical technology has led to significant strains in surgical training. Additionally, the current COVID-19 pandemic has placed substantial limitations on surgical training worldwide. Contact free, remote, web-based, validated learning tools which are easily accessible and allows repeated, sustained practice are the need of the hour. Cognitive Task Analysis (CTA) have been used extensively to train pilots and military personnel and has shown excellent early results within orthopaedic training. We designed a femoral nailing CTA tool which showed objective benefits in the enhancement of cognitive knowledge in medical students. The aim of this study was to evaluate the effectiveness of this CTA tool to enhance practical skills in orthopaedic trainees in a real time interactive simulation setting (Distributed Interactive Simulation (DIS)).
METHODS


This was a double blinded, randomized controlled trial. 14 junior orthopaedic residents who met the inclusion criteria were recruited in the study. They were randomized into two equal groups. The intervention group were given the CTA learning tool, the control group were given a standard operative technique manual used for antegrade femoral intramedullary nailing. The participants were assessed on a high-fidelity phantom femur model with actual femoral nailing instruments in a simulation mobile operating theatre where the candidate had a simulation patient, an acting anesthetist and a scrub nurse (DIS). They were assessed using the modified Objective Structured Assessment of Technical Skills (OSATS) rating scale which has been validated for orthopaedic trauma.
RESULTS


The median OSATS score in the intervention group was 49 (±4.93, range 39-55) compared to 17 in the control group (±14.98, range 12-51). The median improvement was by 32 points (p = 0.02). The ICC between the two raters was 0.977.
CONCLUSIONS


This study has demonstrated objective benefits of a novel femoral nailing CTA tool in the enhancement of practical skills for junior trainees in the DIS setting. This adds to the growing evidence supporting the use of CTA in orthopaedic training. This tool can be accessed remotely, is contact free and allows repeated sustained practice which is key in simulation training.",2021,This study has demonstrated objective benefits of a novel femoral nailing CTA tool in the enhancement of practical skills for junior trainees in the DIS setting.,"['orthopaedic trainees', 'junior trainees in the DIS setting', '14 junior orthopaedic residents who met the inclusion criteria were recruited in the study', 'medical students']","['Cognitive Task Analysis (CTA', 'Imperial Femoral Intramedullary Nailing Cognitive Task Analysis (IFINCTA', 'CTA learning tool, the control group were given a standard operative technique manual used for antegrade femoral intramedullary nailing', 'femoral nailing CTA', 'novel femoral nailing CTA', 'CTA']","['median improvement', 'median OSATS score', 'Technical Skills (OSATS) rating scale']","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0556033', 'cui_str': 'Work analysis'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",14.0,0.0765115,This study has demonstrated objective benefits of a novel femoral nailing CTA tool in the enhancement of practical skills for junior trainees in the DIS setting.,"[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Bhattacharyya', 'Affiliation': 'ST8 Orthopaedic Registrar, Honorary Clinical Research Fellow, Imperial College London. Electronic address: rahulbhattacharyya09@gmail.com.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Al-Obaidi', 'Affiliation': 'Orthopaedic senior trauma fellow, Imperial College Hospitals NHS Trust, London. Electronic address: bajobaidi@yahoo.com.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sugand', 'Affiliation': 'Orthopaedic trainee, North West Thames rotation London. Electronic address: kapil.sugand04@imperial.ac.uk.'}, {'ForeName': 'Rajarshi', 'Initials': 'R', 'LastName': 'Bhattacharya', 'Affiliation': 'Clinical director in orthopaedics, plastics and major trauma, Imperial College Hospitals NHS Trust, London. Electronic address: rajarshi.bhattacharya@imperial.ac.uk.'}, {'ForeName': 'Chinmay M', 'Initials': 'CM', 'LastName': 'Gupte', 'Affiliation': 'Clinical Reader and consultant orthopaedic surgeon, Imperial College London. Electronic address: c.gupte00@imperial.ac.uk.'}]",Injury,['10.1016/j.injury.2021.02.090']
617,33745228,"A pilot feasibility study of an unguided, internet-delivered cognitive behavioral therapy program for irritable bowel syndrome.","BACKGROUND


Irritable bowel syndrome (IBS) is linked with lower health-related quality of life. Cognitive behavioral therapy (CBT) designed for IBS management can improve outcomes but further research of more accessible implementations of this treatment approach for IBS is needed. This study assessed the feasibility of a web-delivered CBT program among adults with IBS to apply to a future clinical trial.
METHODS


Twenty-five participants were randomized to receive an unguided web-based, CBT program for IBS. The primary outcome was changes in IBS symptom severity (IBS Symptom Severity Scale [IBS-SSS]). Secondary outcomes included IBS-specific CBT therapeutic mechanisms of change (GI-specific anxiety, unhelpful IBS behaviors, and GI-focused cognitions) and changes in depressive (Patient Health Questionnaire-9 [PHQ-9]) and anxiety (Generalized Anxiety Disorder-7 scale [GAD-7]) symptom severity.
KEY RESULTS


Among participants randomized to receive web-based CBT, the average baseline IBS-SSS score was 296.3 (SD=100.9). IBS symptom severity significantly improved at 2-month (p < 0.001) and 3-month follow-up (p < 0.0001); the within-group effect size between baseline and 3-month follow-up IBS-SSS scores was large (d = 1.14) and 63.6% experienced a clinically meaningful improvement (ie, ≥50-point IBS-SSS score reduction). GI-specific anxiety symptoms and cognitions significantly improved at 2-month follow-up, as did unhelpful IBS safety behaviors. Additionally, clinically meaningful improvement was observed in depressive and anxiety symptoms at 3-month follow-up among participants with symptoms above the clinical threshold (ie, PHQ-9 ≥ 10 and GAD-7 ≥ 10, respectively) at baseline.
CONCLUSIONS & INFERENCES


These preliminary findings warrant a larger trial to investigate an unguided, web-based CBT for IBS symptom management that is powered to detect between-group treatment effects.",2021,"IBS symptom severity significantly improved at 2-month (p < 0.001) and 3-month follow-up (p < 0.0001); the within-group effect size between baseline and 3-month follow-up IBS-SSS scores was large (d = 1.14) and 63.6% experienced a clinically meaningful improvement (ie, ≥50-point IBS-SSS score reduction).","['Twenty-five participants', 'adults with IBS', 'irritable bowel syndrome']","['unguided, internet-delivered cognitive behavioral therapy program', 'CBT program', 'Cognitive behavioral therapy (CBT', 'unguided web-based, CBT program for IBS']","['IBS symptom severity', 'anxiety (Generalized Anxiety Disorder-7 scale [GAD-7]) symptom severity', 'IBS-specific CBT therapeutic mechanisms of change (GI-specific anxiety, unhelpful IBS behaviors, and GI-focused cognitions) and changes in depressive (Patient Health Questionnaire-9', 'average baseline IBS-SSS score', 'IBS symptom severity (IBS Symptom Severity Scale [IBS-SSS', 'GI-specific anxiety symptoms and cognitions', 'depressive and anxiety symptoms']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",25.0,0.0900536,"IBS symptom severity significantly improved at 2-month (p < 0.001) and 3-month follow-up (p < 0.0001); the within-group effect size between baseline and 3-month follow-up IBS-SSS scores was large (d = 1.14) and 63.6% experienced a clinically meaningful improvement (ie, ≥50-point IBS-SSS score reduction).","[{'ForeName': 'Jocelynn T', 'Initials': 'JT', 'LastName': 'Owusu', 'Affiliation': 'Mahana Therapeutics, Inc, San Francisco, CA, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sibelli', 'Affiliation': 'Mahana Therapeutics, Inc, San Francisco, CA, USA.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Department of Psychology, King's College London, UK.""}, {'ForeName': 'Miranda A L', 'Initials': 'MAL', 'LastName': 'van Tilburg', 'Affiliation': 'College of Pharmacy & Health Sciences, Campbell University, Buies Creek, NC, USA.'}, {'ForeName': 'Rona L', 'Initials': 'RL', 'LastName': 'Levy', 'Affiliation': 'School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Oser', 'Affiliation': 'Mahana Therapeutics, Inc, San Francisco, CA, USA.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14108']
618,33740736,"Evaluation of the efficacy of platelet-rich plasma on healing of clean diabetic foot ulcers: A randomized clinical trial in Tehran, Iran.","BACKGROUND AND AIMS


Diabetic foot ulcers (DFUs) are among challenging hurdles both for the patient and the physician. There is a recent trend toward finding novel and clinically efficient modalities to treat this potentially hazardous complication of diabetes mellitus in a timely manner. Herein, we aim to appraise the efficacy of platelet-rich plasma (PRP) in healing of clean DFUs.
METHODS


90 patients with clean DFUs consisting of 56 (62.2%) males and 34 (37.8%) females with mean age (±standard deviation) of 56.52 (±7.14) years were enrolled in this study between June 2017 and December 2018. They were randomly allocated into control group (47 patients who received conventional dressing along with silver sulfadiazine ointment twice daily), and case group (43 patients who received PRP gel twice weekly for 3 weeks). All the patients were followed up for 6 months.
RESULTS


Our study showed that PRP significantly increased the healing rate of DFUs regardless of the age (p-value: 0.0), gender (p-value: 0.0), or smoking (p-value: 0.0) and blood pressure (p-value: 0.0) status of patients, but it did not have a significant impact on the need for amputation (p-value: 0.11), level of amputation (p-value: 0.16), or the need for further treatments such as graft or angioplasty (p-value: 0.52).
CONCLUSION


Regardless of the age, gender, or smoking and blood pressure status of patients, PRP can be efficiently used in diabetic patients to accelerate the healing rate of foot ulcers.",2021,"Our study showed that PRP significantly increased the healing rate of DFUs regardless of the age (p-value: 0.0), gender (p-value: 0.0), or smoking (p-value: 0.0) and blood pressure (p-value: 0.0) status of patients, but it did not have a significant impact on the need for amputation (p-value: 0.11), level of amputation (p-value: 0.16), or the need for further treatments such as graft or angioplasty (p-value: 0.52).
","['clean diabetic foot ulcers', '90 patients with clean DFUs consisting of 56 (62.2%) males and 34 (37.8%) females with mean age (±standard deviation) of 56.52 (±7.14) years were enrolled in this study between June 2017 and December 2018', 'Tehran, Iran']","['PRP gel', 'conventional dressing along with silver sulfadiazine ointment', 'PRP', 'platelet-rich plasma', 'platelet-rich plasma (PRP']","['blood pressure', 'healing rate of foot ulcers', 'level of amputation', 'healing rate of DFUs regardless']","[{'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0037134', 'cui_str': 'silver sulfadiazine'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]",90.0,0.0158042,"Our study showed that PRP significantly increased the healing rate of DFUs regardless of the age (p-value: 0.0), gender (p-value: 0.0), or smoking (p-value: 0.0) and blood pressure (p-value: 0.0) status of patients, but it did not have a significant impact on the need for amputation (p-value: 0.11), level of amputation (p-value: 0.16), or the need for further treatments such as graft or angioplasty (p-value: 0.52).
","[{'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Malekpour Alamdari', 'Affiliation': 'Critical Care Quality Improvement Research Center at Shahid Modarres Hospital, Department of General Surgery, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Clinical Research and Development Center at Shahid Modarres Hospital, Department of General Surgery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Shafiee', 'Affiliation': 'Clinical Research and Development Center at Shahid Modarres Hospital, Department of General Surgery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Mirmohseni', 'Affiliation': 'Clinical Research and Development Center at Shahid Modarres Hospital, Department of General Surgery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Besharat', 'Affiliation': 'Clinical Research and Development Center at Shahid Modarres Hospital, Department of Radiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: besharat.sara@gmail.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2021.03.005']
619,33754249,Efficacy of simplified-cognitive behavioral therapy for insomnia(S-CBTI) among female COVID-19 patients with insomnia symptom in Wuhan mobile cabin hospital.,"BACKGROUND


The outbreak of Coronavirus Disease-2019 (COVID-19) caused great psychological distress often with comorbid insomnia. Insomnia is common in patients with COVID-19 admitted to mobile cabin hospitals. Insomnia may lead to immune dysfunction, a condition not conducive to recovery from COVID-19. The use of sedative-hypnotic drugs is limited by their inhibitory effect on the respiratory system. A paucity of research is available regarding psychotherapy interventions to improve insomnia symptoms among  patients with COVID-19. In the general population, sleep problems are more common in women than in men; insomnia in women patients requires special attention. The aim of this study was to develop simplified-cognitive behavioral therapy for insomnia (S-CBTI) for patients with COVID-19 and comorbid insomnia symptoms and to verify its effectiveness through a self-control trial. A second aim was to compare the effectiveness of S-CBTI between acute and chronic insomnia among women with COVID-19 and comorbid insomnia symptoms in Wuhan Jianghan Cabin Hospital.
METHODS


S-CBTI consisted of education on COVID-19 and sleep hygiene, stimulus control, sleep restriction, and self-suggestion relaxation training over a period of two consecutive weeks. Of 67 women, 66 completed psychological intervention and baseline and post-intervention assessments. There were 31 women with acute insomnia and 35 with chronic insomnia. The Insomnia Severity Index (ISI) score and self-compiled sleep data were assessed at baseline and post-intervention, and subjective sleep evaluations were assessed at days 4, 7, 12, and 14.
RESULTS


The ISI score, sleep latency, night sleep time, and sleep efficiency were statistically significantlly improved from baseline to post-intervention by paired T-test. After the intervention, the mean ISI score of the acute insomnia group was lower than that of the chronic insomnia group. The reduction of the ISI score and the improvement of sleep time from baseline to post-intervention in the acute insomnia group were greater than those in the chronic insomnia group. Utilization of sedative-hypnotic drugs in the acute insomnia group was less than that in the chronic insomnia group, and the difference was statistically significant.
CONCLUSIONS


S-CBTI can improve the insomnia symptoms of women with COVID-19 in mobile cabin hospitals, especially for stress-related acute insomnia.",2021,"Utilization of sedative-hypnotic drugs in the acute insomnia group was less than that in the chronic insomnia group, and the difference was statistically significant.
","['women with COVID-19 and comorbid insomnia symptoms in Wuhan Jianghan Cabin Hospital', '31 women\xa0with acute insomnia and 35 with chronic insomnia', 'female COVID-19 patients with insomnia symptom in Wuhan mobile cabin hospital', '67 women, 66 completed psychological intervention and baseline and post-intervention assessments', 'patients with\xa0COVID-19 and comorbid insomnia symptoms', 'patients with\xa0COVID-19', 'patients with\xa0COVID-19 admitted to mobile cabin hospitals']","['education on\xa0COVID-19 and sleep hygiene, stimulus control, sleep restriction, and self-suggestion relaxation training', 'S-CBTI', 'simplified-cognitive behavioral therapy']","['Insomnia', 'Insomnia Severity Index (ISI) score and self-compiled sleep data', 'ISI score', 'sleep time', 'ISI score, sleep latency, night sleep time, and sleep efficiency', 'mean\xa0ISI score', 'insomnia symptoms', 'subjective sleep evaluations']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4546137', 'cui_str': 'Acute insomnia'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0871436', 'cui_str': 'Stimulus control'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",67.0,0.0345187,"Utilization of sedative-hypnotic drugs in the acute insomnia group was less than that in the chronic insomnia group, and the difference was statistically significant.
","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Psychiatry, Zhengzhou University First Affiliated Hospital, Zhengzhou, 450052, Henan, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Psychiatry, Zhengzhou University First Affiliated Hospital, Zhengzhou, 450052, Henan, People's Republic of China.""}, {'ForeName': 'Jianyue', 'Initials': 'J', 'LastName': 'Pang', 'Affiliation': ""Department of Psychiatry, Zhengzhou University First Affiliated Hospital, Zhengzhou, 450052, Henan, People's Republic of China.""}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Department of Respiratory, Zhengzhou University First Affiliated Hospital, Zhengzhou, 450052, Henan, China.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Infectious Diseases, Zhengzhou University First Affiliated Hospital, Zhengzhou, 450052, Henan, China.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""Department of Psychiatry, Zhengzhou University First Affiliated Hospital, Zhengzhou, 450052, Henan, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Psychiatry, Zhengzhou University First Affiliated Hospital, Zhengzhou, 450052, Henan, People's Republic of China.""}, {'ForeName': 'Hengfen', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Psychiatry, Zhengzhou University First Affiliated Hospital, Zhengzhou, 450052, Henan, People's Republic of China. fcclihf2@zzu.edu.com.""}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-021-02350-y']
620,33824389,Improves symptoms and urinary biomarkers in refractory interstitial cystitis/bladder pain syndrome patients randomized to extracorporeal shock wave therapy versus placebo.,"Extracorporeal shock wave therapy (ESWT) has been shown to improve symptoms in patients with interstitial cystitis/bladder pain syndrome (IC/BPS); however, there is a lack of objective evidence. We measured change of urinary biomarker levels in 25 patients with IC/BPS received ESWT or placebo once a week for 4 weeks. Urines were collected from participants at baseline, 4 and 12 weeks post treatment. A representative 41 inflammatory growth factors, cytokines, and chemokines in urine were measured using a MILLIPLEX immunoassay kit. Symptom bother was assessed by O'Leary-Sant symptom scores (OSS), and visual analog scale (VAS) for pain. The ESWT group exhibited a significant reduction in the OSS and VAS compared to the placebo group 4 weeks post-treatment (P < 0.05), and the effects were persistent at 12 weeks. The difference in urinary markers change in ESWT versus placebo was P = 0.054 for IL4, P = 0.013 for VEGF, and P = 0.039 for IL9 at 4 weeks. The change of urine biomarker was not significant in other biomarkers or all the measured proteins at 12 weeks. The current data suggest that IL4, IL9, and VEGF mediation may be involved in its pathophysiologic mechanisms and response to LESW treatment.",2021,"The ESWT group exhibited a significant reduction in the OSS and VAS compared to the placebo group 4 weeks post-treatment (P < 0.05), and the effects were persistent at 12 weeks.","['refractory interstitial cystitis/bladder pain syndrome patients', '25 patients with IC/BPS received', 'patients with interstitial cystitis/bladder pain syndrome (IC/BPS']","['Extracorporeal shock wave therapy (ESWT', 'placebo', 'ESWT or placebo', 'extracorporeal shock wave therapy versus placebo']","['Symptom bother', 'change of urine biomarker', 'urinary markers change', ""O'Leary-Sant symptom scores (OSS), and visual analog scale (VAS) for pain"", 'OSS and VAS', 'urinary biomarker levels']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",25.0,0.1983,"The ESWT group exhibited a significant reduction in the OSS and VAS compared to the placebo group 4 weeks post-treatment (P < 0.05), and the effects were persistent at 12 weeks.","[{'ForeName': 'Yuan-Chi', 'Initials': 'YC', 'LastName': 'Shen', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, 123 Ta Pei Road, Niao Song District, Kaohsiung, Taiwan.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Tyagi', 'Affiliation': 'Department of Urology, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Wei-Chia', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, 123 Ta Pei Road, Niao Song District, Kaohsiung, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chancellor', 'Affiliation': 'Department of Urology, Beaumont Health System, Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA.'}, {'ForeName': 'Yao-Chi', 'Initials': 'YC', 'LastName': 'Chuang', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, 123 Ta Pei Road, Niao Song District, Kaohsiung, Taiwan. chuang82@ms26.hinet.net.'}]",Scientific reports,['10.1038/s41598-021-87040-1']
621,33753456,FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer.,"On December 20, 2019, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki [DS-8201a; T-DXd; tradename ENHERTU (Daiichi Sankyo)] for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Approval was based on data from study DS8201-A-U201 (DESTINY-Breast01) with supportive safety data from study DS8201-A-J101. The primary efficacy endpoint in DESTINY-Breast01 was overall response rate (ORR) based on confirmed responses by blinded independent central review (ICR) using RECIST v1.1 in all participants who were assigned to receive the recommended dose of 5.4 mg/kg while secondary endpoints included duration of response (DoR). The confirmed ORR based on ICR in these 184 patients was 60.3% [95% confidence interval (CI): 52.9-67.4] and the median DoR was 14.8 months (95% CI: 13.8-16.9). Interstitial lung disease, including pneumonitis, was experienced in patients treated with T-DXd and can be severe, life threatening, or fatal. In addition, neutropenia and left ventricular dysfunction were included as Warnings and Precautions in labeling. Other important common adverse reactions were nausea, fatigue, vomiting, alopecia, constipation, decreased appetite, anemia, diarrhea, and thrombocytopenia. Overall, the totality of efficacy and safety data supported the accelerated approval of T-DXd for the intended indication.",2021,"Overall, the totality of efficacy and safety data supported the accelerated approval of T-DXd for the intended indication.","['adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting', 'unresectable or metastatic HER2-positive breast cancer']",[],"['overall response rate (ORR', 'Interstitial lung disease (ILD', 'nausea, fatigue, vomiting, alopecia, constipation, decreased appetite, anemia, diarrhea, and thrombocytopenia', 'median DoR', 'duration of response (DoR', 'neutropenia and left ventricular dysfunction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}]",,0.280871,"Overall, the totality of efficacy and safety data supported the accelerated approval of T-DXd for the intended indication.","[{'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. preeti.narayan@fda.hhs.gov.'}, {'ForeName': 'Christy L', 'Initials': 'CL', 'LastName': 'Osgood', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Haw-Jyh', 'Initials': 'HJ', 'LastName': 'Chiu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Tiffany K', 'Initials': 'TK', 'LastName': 'Ricks', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Chiu Yuen Chow', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Junshan', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Namuswe', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Guiterrez-Lugo', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Hou', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pierce', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-4557']
622,33752446,Effects of acupuncture versus cognitive behavioral therapy on brain-derived neurotrophic factor in cancer survivors with insomnia: an exploratory analysis.,"INTRODUCTION


Decreased brain-derived neurotrophic factor (BDNF) is associated with poor sleep. This study examined the effects of acupuncture versus cognitive behavioral therapy for insomnia (CBT-I) on serum BDNF and sleep outcomes in cancer survivors with insomnia.
METHODS


This was an exploratory analysis of a randomized clinical trial (n = 160) comparing acupuncture versus CBT-I for cancer survivors with insomnia. Interventions were delivered over 8 weeks. Outcomes were assessed at baseline and week 8. Serum BDNF was evaluated with enzyme-linked immunosorbent assay (ELISA). Sleep was evaluated with the insomnia severity index and consensus sleep diary. Pearson correlations between BDNF and sleep outcomes were calculated. Data analysis was limited to 87 survivors who provided serum samples.
RESULTS


Among 87 survivors, the mean age was 61.9 (SD: 11.4) years, 51.7% were women, and 24.1% were non-White. Mean serum BDNF did not significantly increase in acupuncture (n = 50) or CBT-I (n = 37) groups. When analysis was restricted to patients with low baseline BDNF (i.e. levels below the sample median of 47.1 ng/mL), the acupuncture group (n = 22) demonstrated a significant 7.2 ng/mL increase in mean serum BDNF (P = 0.03), whereas the CBT-I group (n = 21) demonstrated a non-significant 2.9 ng/mL increase (P = 0.28). Serum BDNF was not significantly correlated with sleep outcomes (all P > 0.05).
CONCLUSION


Among cancer survivors with insomnia and low baseline BDNF, acupuncture significantly increased serum BDNF levels; however, the clinical significance of this finding requires further investigation. Trial registration no.  NCT02356575 (ClinicalTrials.gov).",2021,Mean serum BDNF did not significantly increase in acupuncture (n = 50) or CBT-I (n = 37) groups.,"['cancer survivors with insomnia', '87 survivors who provided serum samples', '87 survivors, the mean age was 61.9 (SD: 11.4) years, 51.7% were women, and 24.1% were non-White']","['acupuncture', 'cognitive behavioral therapy', 'acupuncture versus cognitive behavioral therapy']","['Mean serum BDNF', 'mean serum BDNF', 'Serum BDNF', 'serum BDNF levels', 'insomnia severity index and consensus sleep diary', 'serum BDNF and sleep outcomes', 'Sleep']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",160.0,0.138269,Mean serum BDNF did not significantly increase in acupuncture (n = 50) or CBT-I (n = 37) groups.,"[{'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'Liou', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Q Susan', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'Keimya', 'Initials': 'K', 'LastName': 'Sadeghi', 'Affiliation': 'Molecular Epidemiology Laboratory, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'Isidora', 'Initials': 'I', 'LastName': 'Autuori', 'Affiliation': 'Molecular Epidemiology Laboratory, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Orlow', 'Affiliation': 'Molecular Epidemiology Laboratory, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528421999395']
623,33751402,Storm of Cardiovascular Markers After LPS Administration in Human Volunteers.,"Acute infections are associated with an elevated cardiovascular risk. However, little is known about the interactions of acute inflammatory responses and the cardiovascular system. We therefore aimed to evaluate effects of acute inflammatory stimuli mediated by LPS administration on a set of 89 cardiovascular biomarkers. A single-blinded, placebo-controlled cross-over study using the human endotoxin model was performed. Ten healthy men were administered lipopolysaccharide (LPS) or placebo on two different study days after an overnight fast. Eighty-nine different cardiovascular biomarkers were measured repetitively over 48 h. Out of 89 cardiovascular biomarkers, 54 markers were significantly influenced by LPS infusion. The observed biomarker response to inflammation was more pronounced and complex than anticipated. In conclusion, our data show that the cardiovascular system is under enormous distress in response to experimental low-dose inflammation in humans, as demonstrated by a significant effect on 54 of the 89 biomarkers tested.",2021,"Out of 89 cardiovascular biomarkers, 54 markers were significantly influenced by LPS infusion.","['Human Volunteers', 'Ten healthy men']","['placebo', 'lipopolysaccharide (LPS) or placebo', 'LPS']","['Cardiovascular Markers', 'cardiovascular biomarkers']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",10.0,0.115263,"Out of 89 cardiovascular biomarkers, 54 markers were significantly influenced by LPS infusion.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Resl', 'Affiliation': 'Department of Medicine, St. John of God Hospital Linz, Seilerstaette 2, 4021, Linz, Austria.'}, {'ForeName': 'Matthias Wolfgang', 'Initials': 'MW', 'LastName': 'Heinzl', 'Affiliation': 'Department of Medicine, St. John of God Hospital Linz, Seilerstaette 2, 4021, Linz, Austria.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Klammer', 'Affiliation': 'Department of Medicine, St. John of God Hospital Linz, Seilerstaette 2, 4021, Linz, Austria.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Egger', 'Affiliation': 'Department of Laboratory Medicine, St. John of God Hospital Linz, ICMR - Institute for Cardiovascular and Metabolic Research, JKU Linz, Linz, Austria.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Feldbauer', 'Affiliation': 'Department of Medicine, St. John of God Hospital Linz, Seilerstaette 2, 4021, Linz, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Pohlhammer', 'Affiliation': 'Department of Medicine, St. John of God Hospital Linz, Seilerstaette 2, 4021, Linz, Austria.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Dieplinger', 'Affiliation': 'Department of Laboratory Medicine, St. John of God Hospital Linz, ICMR - Institute for Cardiovascular and Metabolic Research, JKU Linz, Linz, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Clodi', 'Affiliation': 'Department of Medicine, St. John of God Hospital Linz, Seilerstaette 2, 4021, Linz, Austria. martin.clodi@bblinz.at.'}]",Journal of cardiovascular translational research,['10.1007/s12265-021-10109-9']
624,33755149,"Comparative bioavailability of curcuminoids from a water-dispersible high curcuminoid turmeric extract against a generic turmeric extract: a randomized, cross-over, comparative, pharmacokinetic study.","OBJECTIVES


The therapeutic utility of turmeric (Curcuma longa L., Zingiberaceae) is limited due to low bioavailability of its active principal curcuminoids. This study evaluates the pharmacokinetic characteristics of a natural, water-dispersible turmeric extract containing 60% curcuminoids (TurmXtra 60N), referred to as WDTE60N, compared to standard turmeric extract 95% (STE95).
METHODS


This open-label, two-way crossover, single oral dose, comparative pharmacokinetic study, randomized 14 subjects to receive one capsule of WDTE60N (150 mg curcuminoids) or three capsules of STE95 (500 mg curcuminoids each). The resulting dose ratio of actives for WDTE60N:STE95 was 1:10.
KEY FINDINGS


Peak plasma levels of free curcumin, total curcuminoids, tetrahydrocurcumin and demethoxycurcumin were similar (P > 0.05). Cmax of total curcumin was higher (P = 0.0253) for WDTE60N at a 10-fold lower dose compared to STE95 (43.5 ± 28.5 vs. 21.3 ± 10.7 ng/ml). Mean AUC0-t was higher (P < 0.001) for free curcumin and comparable for total curcumin and total curcuminoids with WDTE60N than with STE95. Five adverse events were reported in three subjects (mild in severity) and were unrelated to study products.
CONCLUSION


WDTE60N showed higher absorption and comparable exposure for free curcumin, total curcumin and total curcuminoids at a 10-fold lower dose than STE95.",2021,Mean AUC0-t was higher (P < 0.001) for free curcumin and comparable for total curcumin and total curcuminoids with WDTE60N than with STE95.,[],"['STE95', 'turmeric (Curcuma longa L., Zingiberaceae']","['Mean AUC0-t', 'Peak plasma levels of free curcumin, total curcuminoids, tetrahydrocurcumin and demethoxycurcumin', 'Cmax of total curcumin', 'free curcumin, total curcumin and total curcuminoids']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0041356', 'cui_str': 'Turmeric'}, {'cui': 'C0524981', 'cui_str': 'Zingiberaceae'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0382876', 'cui_str': 'TETRAHYDRODIFERULOYLMETHANE'}, {'cui': 'C0057364', 'cui_str': 'demethoxycurcumin'}]",14.0,0.0976334,Mean AUC0-t was higher (P < 0.001) for free curcumin and comparable for total curcumin and total curcuminoids with WDTE60N than with STE95.,"[{'ForeName': 'Shefali', 'Initials': 'S', 'LastName': 'Thanawala', 'Affiliation': 'Inventia Healthcare Ltd., Mumbai, Maharashtra, India.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Inventia Healthcare Ltd., Mumbai, Maharashtra, India.'}, {'ForeName': 'KrishnaRaju Venkata', 'Initials': 'KV', 'LastName': 'Alluri', 'Affiliation': 'Laila Nutraceuticals, Vijayawada, Andhra Pradesh, India.'}, {'ForeName': 'Venkateswarlu', 'Initials': 'V', 'LastName': 'Somepalli', 'Affiliation': 'Laila Nutraceuticals, Vijayawada, Andhra Pradesh, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Vaze', 'Affiliation': 'Enem Nostrum Pvt Ltd, Mumbai, Maharashtra, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Upadhyay', 'Affiliation': 'Enem Nostrum Pvt Ltd, Mumbai, Maharashtra, India.'}]",The Journal of pharmacy and pharmacology,['10.1093/jpp/rgab028']
625,33765688,Comparative Effectiveness of the Homeopathic Preparation Traumeel S in Third Molar Extraction Surgery: A Preliminary Triple-Blind Clinical Trial.,"BACKGROUND AND AIM


This preliminary study aimed to evaluate whether a homeopathic preparation ( Traumeel S ) might be a good option to control post-operative outcomes (pain, edema and trismus) associated with surgical removal of mandibular third molar teeth. The null hypothesis was that  Traumeel S  is not different from dexamethasone (gold standard) in controlling these post-operative inflammatory complications.
METHODS


A randomized, ""split-mouth"", triple-blind clinical trial was conducted. Seventeen healthy patients with a mean age of 20.94 ( ± 5.83) years had their lower asymptomatic bilateral third molars removed. Patients were randomized to receive  Traumeel S  or dexamethasone pre-operatively by injection into the masseter muscle; each patient acted as his/her own control. At 24, 48, 72 hours and 7 days after the surgery, the pain was evaluated according to a visual analog scale, edema through linear measurements of the face, and trismus through the maximum buccal opening. Wilcoxon statistics or paired  t -test were used, and a significance level of 95% was adopted.
RESULTS


For pain, the results for  Traumeel S  were not different ( p  > 0.05) from those of dexamethasone after 24 hours, 72 hours, and 7 days. For edema, the results for  Traumeel S  were not different ( p  > 0.05) from those of dexamethasone at all post-operative evaluations. For mouth opening, the results for  Traumeel S  were not different ( p  > 0.05) from those of dexamethasone at 72 hours and 7 days after third molar extraction.
CONCLUSION


With the exception of some early post-operative findings, the null hypothesis is not rejected.  Traumeel S  might be a good alternative approach to dexamethasone for controlling pain, edema and trismus after third molar removal.",2021,"For mouth opening, the results for  Traumeel S  were not different ( p  > 0.05) from those of dexamethasone at 72 hours and 7 days after third molar extraction.
","['Seventeen healthy patients with a mean age of 20.94 (\u2009±\u20095.83) years had their lower asymptomatic bilateral third molars removed', 'Third Molar Extraction Surgery']","['dexamethasone', 'Traumeel S  or dexamethasone pre-operatively by injection into the masseter muscle; each patient acted as his/her own control', 'homeopathic preparation ( Traumeel S ', 'Homeopathic Preparation Traumeel S']","['pain', 'visual analog scale, edema through linear measurements of the face, and trismus through the maximum buccal opening']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191375', 'cui_str': '5.83'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0968917', 'cui_str': 'Traumeel S'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1828121', 'cui_str': 'Injections'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0684199', 'cui_str': 'Homeopathic therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",17.0,0.124064,"For mouth opening, the results for  Traumeel S  were not different ( p  > 0.05) from those of dexamethasone at 72 hours and 7 days after third molar extraction.
","[{'ForeName': 'Glaciele Maria de', 'Initials': 'GM', 'LastName': 'Souza', 'Affiliation': 'Department of Dentistry, Federal University of Vales Jequitinhonha and Mucuri, Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Ighor Andrade', 'Initials': 'IA', 'LastName': 'Fernandes', 'Affiliation': 'Department of Dentistry, Federal University of Vales Jequitinhonha and Mucuri, Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Marcos Luciano Pimenta', 'Initials': 'MLP', 'LastName': 'Pinheiro', 'Affiliation': 'Division of Pharmacology, Department of Dentistry, Federal University of Vales Jequitinhonha and Mucuri, Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Saulo Gabriel Moreira', 'Initials': 'SGM', 'LastName': 'Falci', 'Affiliation': 'Division of Oral and Maxillofacial Surgery, Department of Dentistry, Federal University of Vales Jequitinhonha and Mucuri, Diamantina, Minas Gerais, Brazil.'}]",Homeopathy : the journal of the Faculty of Homeopathy,['10.1055/s-0041-1725038']
626,33759439,Immediate clinical benefits of combining therapeutic exercise and interferential therapy in adults with chronic neck pain: a randomized controlled trial.,"BACKGROUND


Therapeutic exercise (TE) is highly recommended for the management of non-specific neck pain (NSNP) and has shown promising results combined with interferential current therapy. Yet, the clinical relevance of the pooled effect of these approaches remains uncertain.
AIM


To investigate the immediate clinical effect size of combining TE and interferential therapy, compared with the isolated use of TE, in adults with chronic NSNP.
DESIGN


Randomized, single-blinded, controlled, superiority trial.
SETTING


Outpatients, primary care center.
POPULATION


Forty-nine adults with chronic NSNP.
METHODS


Participants with neck pain (grades I or II) lasting for more than 12 weeks were allocated to a TE plus interferential currents group (N.=25) or to a TE only group (N.=24). All individuals underwent treatment 5 times a week for 2 weeks. The primary outcome was current neck pain intensity (11-point Numeric Pain Rating Scale). Secondary outcomes included neck disability (Neck Disability Index) and active cervical range-of-movement (CROM device). Measurements were taken at baseline and immediately after treatment. An intention-to-treat analysis was carried out. To quantify the effect size of the interventions, the relative risk, the absolute and relative risk reduction, and the number needed to treat (NNT) were calculated.
RESULTS


A significant time*group effect was found for pain intensity, disability, and neck flexion and right rotation (all, P<0.05). In the analysis for treatment benefit, the NNT was 2 (95% CI: 2 to 4, P<0.001) for neck pain and disability, and 3 (95% CI: 2 to 11, P=0.029) for neck flexion.
CONCLUSIONS


Adding interferential therapy to TE is clinically more effective than TE alone to immediately improve neck pain and disability, but not active cervical range-of-movement, in adults with persistent neck pain.
CLINICAL REHABILITATION IMPACT


Our results suggest that this multimodal intervention can be a useful strategy for rehabilitation of patients with NSNP. This is the first study on this topic reporting findings in terms of clinical relevance, which is key to transfer research evidence into practice.",2021,"Adding interferential therapy to therapeutic exercise is clinically more effective than therapeutic exercise alone to immediately improve neck pain and disability, but not active cervical range-of-movement, in adults with persistent neck pain.
","['Outpatients, primary care center', 'patients with non-specific neck pain', 'adults with chronic neck pain', 'Participants with neck pain (grades I or II) lasting for more than 12 weeks', 'adults with chronic non-specific neck pain', 'Forty-nine adults with chronic non-specific neck pain', 'adults with persistent neck pain']","['therapeutic exercise plus interferential currents group (n = 25) or to a therapeutic exercise', 'therapeutic exercise and interferential therapy']","['neck disability (Neck Disability Index) and active cervical range-of-movement (CROM device', 'current neck pain intensity (11-point numeric pain rating scale', 'pain intensity, disability, and neck flexion and right rotation', 'neck pain and disability']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0556898', 'cui_str': 'Interferential therapy'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1292305', 'cui_str': 'Cromer blood group system'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",49.0,0.0969323,"Adding interferential therapy to therapeutic exercise is clinically more effective than therapeutic exercise alone to immediately improve neck pain and disability, but not active cervical range-of-movement, in adults with persistent neck pain.
","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Albornoz-Cabello', 'Affiliation': 'Department of Physical Therapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'Cristo J', 'Initials': 'CJ', 'LastName': 'Barrios-Quinta', 'Affiliation': 'Unit of Physiotherapy, Andalusian Health Service, Sevilla, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Espejo-Antúnez', 'Affiliation': 'Department of Medical-Surgical Therapeutics, Faculty of Medicine, Extremadura University, Badajoz, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Escobio-Prieto', 'Affiliation': 'Department of Physical Therapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Casuso-Holgado', 'Affiliation': 'Department of Physical Therapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain - mcasuso@us.es.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Heredia-Rizo', 'Affiliation': 'Department of Physical Therapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.21.06688-0']
627,33764681,Feasibility of ultrasound-assisted lumbar punctures performed by pediatric oncologists at the point of care.,"BACKGROUND


Ultrasound assistance improves success rates and reduces adverse outcomes of lumbar punctures (LPs) among adult patients in the emergency room and the operating room, but has not been evaluated in pediatric patients with cancer. Our objectives were (1) to determine whether pediatric oncologists could perform ultrasound-assisted LPs following a structured teaching curriculum, and (2) to determine the feasibility of recruiting pediatric cancer patients to a clinical trial of this procedure.
METHODS


Three pediatric oncologists completed a curriculum composed of didactic teaching followed by hands-on workshops. Each learner was evaluated during 20 attempts at three ultrasound tasks using the cumulative sum method. The three pediatric oncologists then performed ultrasound assessments prior to routinely scheduled LPs. Feasibility was defined as ability to perform at least 30 ultrasound-assisted LPs within 6 months. Secondary outcomes were the proportion of successful, bloody, or traumatic LPs, time required, and perceived helpfulness of ultrasound.
RESULTS


All three pediatric oncologists achieved competence in the three tasks of ultrasound scanning within 20 evaluated attempts. We recruited 62 patients within 1 month, and 58 underwent an ultrasound-assisted LP. All LPs were successful. Two LPs (4%) had ≥500 red blood cells (RBCs)/μl, and nine (16%) had ≥10 RBCs/μl. Median time to conduct the scan was 1.9 minutes (range 0.8-4.0 minutes). In 37 (64%) of the LPs, ultrasound assistance was considered helpful or very helpful.
CONCLUSIONS


Pediatric oncologists readily achieved competence in ultrasound-assisted LPs, and ultrasound was commonly perceived as helpful. It is feasible to proceed to a randomized trial of this procedure in pediatric cancer.",2021,"BACKGROUND


Ultrasound assistance improves success rates and reduces adverse outcomes of lumbar punctures (LPs) among adult patients in the emergency room and the operating room, but has not been evaluated in pediatric patients with cancer.","['Three pediatric oncologists completed a curriculum composed of', 'pediatric cancer', 'pediatric patients with cancer', 'adult patients in the emergency room and the operating room', '62 patients within 1\xa0month, and 58 underwent an', 'pediatric cancer patients']","['ultrasound-assisted lumbar punctures', 'didactic teaching followed by hands-on workshops', 'ultrasound-assisted LP', 'Ultrasound assistance']","['≥500\xa0red blood cells', 'Median time to conduct the scan', 'proportion of successful, bloody, or traumatic LPs, time required, and perceived helpfulness of ultrasound']","[{'cui': 'C0279158', 'cui_str': 'Pediatric oncologist'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C2721760', 'cui_str': 'Traumatic lumbar puncture'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",,0.0377664,"BACKGROUND


Ultrasound assistance improves success rates and reduces adverse outcomes of lumbar punctures (LPs) among adult patients in the emergency room and the operating room, but has not been evaluated in pediatric patients with cancer.","[{'ForeName': 'Furqan', 'Initials': 'F', 'LastName': 'Shaikh', 'Affiliation': 'Division of Haematology/Oncology, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Arzola', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': 'Division of Haematology/Oncology, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jose C A', 'Initials': 'JCA', 'LastName': 'Carvalho', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Everett', 'Affiliation': 'Department of Anesthesia and Pain Medicine, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Shroff', 'Affiliation': 'Department of Diagnostic Imaging, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Doria', 'Affiliation': 'Department of Diagnostic Imaging, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Trottier', 'Affiliation': 'Department of Diagnostic Imaging, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'To', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Sung', 'Affiliation': 'Division of Haematology/Oncology, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}]",Pediatric blood & cancer,['10.1002/pbc.29015']
628,33824113,Effectiveness of local drug delivery system using 1% metronidazole gel and mouthwash in treating periodontal diseases.,"The gold standard therapy for treating the periodontal infections is the removal of bacterial plaque and deposits of calculus from tooth surfaces by scaling and root planning. In order to eliminate these bacterial reservoirs, beside conventional treatment, chemo therapeutic agents are commonly prescribed by periodontologists. To avoid the systemic side effects and development of antibiotics resistance, local drug delivery methods has gained the attention of dentists to treat periodontal infections, along with scaling and root planning. The aim of this study was to evaluate the effectiveness of local drug delivery system in combination with scaling and root planning, by using 1% metronidazole gel and mouthwash. The patients were divided into 3 groups. Group I: conventional treatment group. Group II: patients received treatment with gel. Group III: patients received treatment with mouthwash. All groups received treatment for 30 days. Clinical parameters and salivary concentration of TNF-α, PGE2 and nitric oxide were measured before and after treatment in both groups. All clinical parameters and inflammatory biomarkers significantly reduced in gel and mouthwash group patients (p≤0.001) as compared to patients received conventional treatment. The gel is found to be more efficacious than mouthwash especially in reducing clinical attachment loss (p< 0.05) and in reducing inflammatory biomarkers (p≤0.001). We strongly suggest the use of metronidazole via local drug delivery system combined with scaling and root planning to treat periodontal diseases.",2020,All clinical parameters and inflammatory biomarkers significantly reduced in gel and mouthwash group patients (p≤0.001) as compared to patients received conventional treatment.,[],"['metronidazole', 'metronidazole gel and mouthwash', 'mouthwash']","['clinical attachment loss', 'Clinical parameters and salivary concentration of TNF-α, PGE2 and nitric oxide', 'inflammatory biomarkers']",[],"[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0158405,All clinical parameters and inflammatory biomarkers significantly reduced in gel and mouthwash group patients (p≤0.001) as compared to patients received conventional treatment.,"[{'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Hasan', 'Affiliation': 'Department of Pharmacology, Fatima Jinnah Dental College, Karachi, Pakistan.'}, {'ForeName': 'Rahila', 'Initials': 'R', 'LastName': 'Ikram', 'Affiliation': 'Department of Pharmacology, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.'}, {'ForeName': 'Afshan', 'Initials': 'A', 'LastName': 'Abbas', 'Affiliation': 'Department of Pharmacology, Sir Syed College of Medical Sciences, Karachi, Pakistan.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Asadullah', 'Affiliation': 'Crown Dental Clinic, Karachi, Pakistan.'}]",Pakistan journal of pharmaceutical sciences,[]
629,33765358,"Randomized, Open-Label, Single-Dose, Parallel-Group Pharmacokinetic Study of PF-06410293 (adalimumab-afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects.","This open-label, single-dose, randomized, parallel-group, 2-arm phase 1 bioequivalence (BE) study assessed the pharmacokinetics (PK), safety, and tolerability of PF-06410293 (ADL-PF), an adalimumab (ADL) biosimilar, following administration by prefilled pen (PFP) or prefilled syringe (PFS). A total of 164 healthy adult subjects were randomized (1:1) to receive ADL-PF (40 mg subcutaneously) in the lower abdomen or upper anterior thigh by PFS or PFP; 163 subjects were included in the primary PK analysis. The concentration-time profiles of the ADL-PF PFS and PFP treatment arms were similar. The 90% confidence intervals for the test/reference ratios of the primary end points (area under the serum concentration-time profile from time 0 to 2 weeks after dosing and maximum observed serum concentration) fell within the 80.00%-125.00% prespecified margin for BE. Comparable numbers of subjects experienced adverse events (AEs) between treatment groups, and injection-site pain was similar at all times and for the 2 injection-site locations. This study demonstrated the BE of ADL-PF following subcutaneous administration using either a PFS or PFP device. ADL-PF by PFS or PFP injection was well tolerated, with the distribution of AEs, including injection-site reactions, being similar between treatment arms.",2021,"Comparable numbers of subjects experienced adverse events (AEs) between treatment groups, and injection-site pain was similar at all times and for the 2 injection-site locations.","['164 healthy adult subjects', '163 subjects were included in the primary PK analysis', 'Healthy Subjects']","['adalimumab (ADL) biosimilar, following administration by prefilled pen (PFP) or prefilled syringe (PFS', 'ADL-PF (40 mg subcutaneously) in the lower abdomen or upper anterior thigh by PFS or PFP', 'PF-06410293 (adalimumab-afzb']","['pharmacokinetics (PK), safety, and tolerability of PF-06410293 (ADL-PF', 'serum concentration-time profile']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C5198170', 'cui_str': 'PF-06410293'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C0441999', 'cui_str': 'Upper anterior'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C5198170', 'cui_str': 'PF-06410293'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",164.0,0.0994683,"Comparable numbers of subjects experienced adverse events (AEs) between treatment groups, and injection-site pain was similar at all times and for the 2 injection-site locations.","[{'ForeName': 'Donna S', 'Initials': 'DS', 'LastName': 'Cox', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Alvarez', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Bock', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Cronenberger', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.939']
630,33759183,"The benefits of teaching on comprehension, motivation, and perceived difficulty: Empirical evidence of teaching expectancy and the interactivity of teaching.","BACKGROUND


Research regarding teaching expectancy has been mostly conducted in research laboratories with college students. These studies provide insufficient evidence regarding its effect on learners' delayed comprehension. Moreover, the relative superiority of teaching a peer face to face compared to teaching an imagined peer lacks empirical support.
AIMS


The purpose of the study was to investigate the interactivity of teaching by comparing peer teaching to imagined teaching, as well as enhancing the generalizability of the teaching expectancy effect by testing it in a secondary school environment.
SAMPLE


A total of 597 students (282 males) from 12 classes in a secondary school were recruited to participate in the study as part of their psychology course.
METHODS


Participants were randomly assigned to one of six conditions formed by a 2 (teaching expectancy vs. testing expectancy) × 3 (peer teaching vs. imagined teaching vs. no teaching) between-subjects design. Their immediate and delayed comprehension tests, motivation, and perceived difficulty were measured as dependent variables.
RESULTS


Imagined teaching enhanced both immediate and delayed comprehension, but peer teaching only enhanced immediate comprehension. Moreover, the effects of imagined teaching on perceived difficulty and motivation were dependent upon teaching expectancy or testing expectancy.
CONCLUSIONS


Our findings provide empirical evidence to the existing theoretical frameworks, but caution should be taken when applying imagined teaching in practice.",2021,"RESULTS


Imagined teaching enhanced both immediate and delayed comprehension, but peer teaching only enhanced immediate comprehension.","['college students', 'Participants', '597 students (282 males) from 12 classes in a secondary school were recruited to participate in the study as part of their psychology course']","['imagined teaching', '× 3 (peer teaching vs. imagined teaching vs. no teaching', '2 (teaching expectancy vs. testing expectancy']","['delayed comprehension tests, motivation, and perceived difficulty', 'immediate comprehension']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",597.0,0.0909491,"RESULTS


Imagined teaching enhanced both immediate and delayed comprehension, but peer teaching only enhanced immediate comprehension.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Yuncheng Yanhua Middle School, China.'}, {'ForeName': 'Lijia', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Ouhao', 'Initials': 'O', 'LastName': 'Chen', 'Affiliation': 'Mathematics Education Centre, Loughborough University, UK.'}]",The British journal of educational psychology,['10.1111/bjep.12416']
631,33761119,Impact of Fever Prevention in Brain-Injured Patients (INTREPID): Study Protocol for a Randomized Controlled Trial.,"BACKGROUND


Multiple studies demonstrate that fever/elevated temperature is associated with poor outcomes in patients with vascular brain injury; however, there are no conclusive studies that demonstrate that fever prevention/controlled normothermia is associated with better outcomes. The primary objective of the INTREPID (Impact of Fever Prevention in Brain-Injured Patients) trial is to test the hypothesis that fever prevention is superior to standard temperature management in patients with acute vascular brain injury.
METHODS


INTREPID is a prospective randomized open blinded endpoint study of fever prevention versus usual care in patients with ischemic or hemorrhagic stroke. The fever prevention intervention utilizes the Arctic Sun System and will be compared to standard care patients in whom fever may spontaneously develop. Ischemic stroke, intracerebral hemorrhage or subarachnoid hemorrhage patients will be included within disease-specific time-windows. Both awake and sedated patients will be included, and treatment is initiated immediately upon enrollment. Eligible patients are expected to require intensive care for at least 72 h post-injury, will not be deemed unlikely to survive without severe disability, and will be treated for up to 14 days, or until deemed ready for discharge from the ICU, whichever comes first. Fifty sites in the USA and worldwide will participate, with a target enrollment of 1176 patients (1000 evaluable). The target temperature is 37.0 °C. The primary efficacy outcome is the total fever burden by °C-h, defined as the area under the temperature curve above 37.9 °C. The primary secondary outcome, on which the sample size is based, is the modified Rankin Scale Score at 3 months. All efficacy analyses including the primary and key secondary endpoints will be primarily based on an intention-to-treat population. Analysis of the as-treated and per protocol populations will also be performed on the primary and key secondary endpoints as sensitivity analyses.
DISCUSSION


The INTREPID trial will provide the first results of the impact of a pivotal fever prevention intervention in patients with acute stroke ( www.clinicaltrials.gov ; NCT02996266; registered prospectively 05DEC2016).",2021,"The primary secondary outcome, on which the sample size is based, is the modified Rankin Scale Score at 3 months.","['Brain-Injured Patients (INTREPID', 'Brain-Injured Patients', 'Ischemic stroke, intracerebral hemorrhage or subarachnoid hemorrhage patients', '1176 patients (1000 evaluable', 'patients with ischemic or hemorrhagic stroke', 'patients with vascular brain injury', 'patients with acute vascular brain injury', 'patients with acute stroke', 'Eligible patients are expected to require intensive care for at least 72\xa0h post-injury']",['fever prevention versus usual care'],"['modified Rankin Scale Score', 'total fever burden by °C-h, defined as the area under the temperature curve']","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0751814', 'cui_str': 'Brain Injury, Vascular'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.208247,"The primary secondary outcome, on which the sample size is based, is the modified Rankin Scale Score at 3 months.","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Greer', 'Affiliation': 'Department of Neurology, Boston University School of Medicine, Boston Medical Center, Collamore 3, Suite 338, 72 East Concord Street, Boston, MA, USA. dgreer@bu.edu.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ritter', 'Affiliation': 'Becton Dickenson & Company, Franklin Lakes, NJ, USA.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Helbok', 'Affiliation': 'Department of Neurology, Neurology Medical University of Innsbruck, Anichstreet 65, 6020, Innsbruck, Austria.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Badjatia', 'Affiliation': 'Program in Trauma, Department of Neurology, University of Maryland School of Medicine, 655 West Baltimore Street, Baltimore, MD, USA.'}, {'ForeName': 'Sang-Bae', 'Initials': 'SB', 'LastName': 'Ko', 'Affiliation': 'Department of Neurology, Boston University School of Medicine, Boston Medical Center, Collamore 3, Suite 338, 72 East Concord Street, Boston, MA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Guanci', 'Affiliation': 'Neurocritical Care Unit, Massachusetts General Hospital, Lunder Building 6th Floor, 55 Fruit Street, Boston, MA, USA.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Department of Neurology, Yale University School of Medicine, 15 York Street, LCI 1003, New Haven, CT, USA.'}]",Neurocritical care,['10.1007/s12028-021-01208-1']
632,33755096,Haemodynamic benefit of bridging use of bosentan prior to pulmonary endarterectomy.,"OBJECTIVES


Some patients present with excessive pulmonary hypertension (PH) prior to pulmonary endarterectomy (PEA) for chronic thromboembolic pulmonary hypertension (CTEPH). This study was performed to evaluate the clinical role of pretreatment before PEA in CTEPH patients.
METHODS


A total of 370 patients with CTEPH undergoing first PEA between 2003 and 2017 were divided into those receiving pretreatment with bosentan (group B: n = 119) and those without targeted pretreatment for PH (group C: n = 251). After selecting patients given bosentan (2-8 months) and using propensity score matching, comparable patient cohorts (n = 23 each) were created from both groups. PEA was performed in the standard manner, and the median number of extracted segments was 14.
RESULTS


There were no significant differences in perioperative demographic characteristics or 30-day mortality (overall 5.7%) between the groups before and after matching. In patients with preoperative pulmonary vascular resistance (PVR) ≥800 dynes s/cm5, a significantly larger decrease in PVR was found in group B (78%) compared to group C (68%) (P = 0.033). There was no significant difference in late survival between the groups after matching. The frequency of residual/persistent PH (mean pulmonary artery pressure >25 mmHg) was lower in group B than in group C, although the difference was not significant (22% vs 39%, respectively, P = 0.200). Advanced age and longer cardiopulmonary bypass time were independent predictors of both 30-day mortality and residual/persistent PH (odds ratio: age, 1.053, 1.013, cardiopulmonary bypass time, 1.065, 1.010, respectively).
CONCLUSIONS


Preoperative treatment of CTEPH patients with bosentan for 2-8 months can improve post-PEA PVR without adverse clinical events in patients with a high preoperative PVR. A temporary bridging regime appears beneficial in selected patients prior to PEA.",2021,"The frequency of residual/persistent PH (mean pulmonary artery pressure >25 mmHg) was lower in group B than in group C, although the difference was not significant (22% vs 39%, respectively, P = 0.200).","['CTEPH patients', 'patients with a high preoperative PVR', '370 patients with CTEPH undergoing first PEA between 2003 and 2017', 'patients present with excessive pulmonary hypertension (PH) prior to pulmonary endarterectomy (PEA) for chronic thromboembolic pulmonary hypertension (CTEPH', 'selected patients prior to PEA']","['bosentan (group B: n\u2009=\u2009119) and those without targeted pretreatment for PH', 'PEA']","['30-day mortality and residual/persistent PH', 'frequency of residual/persistent PH', 'perioperative demographic characteristics or 30-day mortality', 'PVR', 'Advanced age and longer cardiopulmonary bypass time', 'late survival']","[{'cui': 'C2363973', 'cui_str': 'Chronic thromboembolic pulmonary hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C2066034', 'cui_str': 'Pulmonary endarterectomy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0252643', 'cui_str': 'bosentan'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C2066034', 'cui_str': 'Pulmonary endarterectomy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",370.0,0.019781,"The frequency of residual/persistent PH (mean pulmonary artery pressure >25 mmHg) was lower in group B than in group C, although the difference was not significant (22% vs 39%, respectively, P = 0.200).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kunihara', 'Affiliation': 'Department of Cardiac Surgery, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Heinrike', 'Initials': 'H', 'LastName': 'Wilkens', 'Affiliation': 'Department of Pulmonary Medicine, Saarland University Medical Center, Homburg/Saar, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Halank', 'Affiliation': 'Department of Internal Medicine I, Pneumology, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Held', 'Affiliation': 'Department of Internal Medicine and Respiratory Care, Mission Medical Hospital, Würzburg, Germany.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Nomura', 'Affiliation': 'Department of Cardiovascular Surgery, Shizuoka City Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Igarashi', 'Affiliation': 'Department of Cardiovascular Surgery, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Fumihiro', 'Initials': 'F', 'LastName': 'Sata', 'Affiliation': 'Health Center, Chuo University, Tokyo, Japan.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Schäfers', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Saarland University Medical Center, Homburg/Saar, Germany.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezab137']
633,33757520,Efficacy and safety of single-inhaler extrafine triple therapy versus inhaled corticosteroid plus long-acting beta2 agonist in eastern Asian patients with COPD: the TRIVERSYTI randomised controlled trial.,"BACKGROUND


A single-inhaler extrafine triple combination of beclometasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium (G) has been developed for maintenance therapy of chronic obstructive pulmonary disease (COPD). This study evaluated the efficacy and safety of BDP/FF/G in patients in three eastern Asian areas: China, Republic of Korea and Taiwan.
METHODS


TRIVERSYTI was a double-blind, randomised, active-controlled, parallel-group study in patients with COPD, post-bronchodilator forced expiratory volume in 1 s (FEV 1 ) < 50% predicted, ≥ 1 exacerbation in the previous 12 months, and receiving inhaled maintenance medication. Patients received either extrafine BDP/FF/G 100/6/10 µg via pressurised metered-dose inhaler, or non-extrafine budesonide/formoterol (BUD/FF) 160/4.5 µg via dry-powder inhaler, both administered as two puffs twice-daily for 24 weeks. The co-primary objectives (analysed in the overall population) were to demonstrate superiority of BDP/FF/G over BUD/FF for change from baseline in pre-dose morning and 2-h post-dose FEV 1  at Week 24 (these were analysed as key secondary objectives in the China subgroup). The rate of moderate/severe COPD exacerbations was a secondary endpoint.
RESULTS


Of 708 patients randomised, 88.8% completed. BDP/FF/G was superior to BUD/FF for pre-dose and 2-h post-dose FEV 1  at Week 24 [adjusted mean differences 62 (95% CI 38, 85) mL and 113 (87, 140) mL; both p < 0.001]. The annualised moderate/severe exacerbation rate was 43% lower with BDP/FF/G [rate ratio 0.57 (95% CI 0.42, 0.77); p < 0.001]. Adverse events were reported by 61.1% and 67.0% patients with BDP/FF/G and BUD/FF. Results were similar in the China subgroup.
CONCLUSIONS


In patients with COPD, FEV 1  < 50% and an exacerbation history despite maintenance therapy, treatment with extrafine BDP/FF/G improved bronchodilation, and was more effective at preventing moderate/severe COPD exacerbations than BUD/FF. Trial registration CFDA CTR20160507 (registered 7 Nov 2016, http://www.chinadrugtrials.org.cn/index.html ).",2021,BDP/FF/G was superior to BUD/FF for,"['708 patients randomised, 88.8% completed', 'chronic obstructive pulmonary disease (COPD', 'patients in three eastern Asian areas: China, Republic of Korea and Taiwan', 'patients with COPD, post-bronchodilator forced expiratory volume in 1\xa0s ', 'eastern Asian patients with COPD']","['BDP/FF/G', 'extrafine budesonide/formoterol (BUD/FF) 160/4.5', 'beclometasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium (G', 'extrafine', 'single-inhaler extrafine triple therapy']","['rate of moderate/severe COPD exacerbations', 'Adverse events', 'annualised moderate/severe exacerbation rate', 'moderate/severe COPD exacerbations', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]","[{'cui': 'C0004906', 'cui_str': 'Beclomethasone dipropionate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.798658,BDP/FF/G was superior to BUD/FF for,"[{'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Centre for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Baldi', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Largo Belloli, 11\\a, 43122, Parma, Italy.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shanghai Pulmonary Hospital, Shanghai, China.'}, {'ForeName': 'Kwan-Ho', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Yeungnam University Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, The University of Manchester, Manchester University NHS Foundations Trust, Manchester, UK.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Respiratory Medicine Unit, University of Ferrara, University Hospital S. Anna, Ferrara, Italy.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Grapin', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Largo Belloli, 11\\a, 43122, Parma, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Guasconi', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Largo Belloli, 11\\a, 43122, Parma, Italy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Georges', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Largo Belloli, 11\\a, 43122, Parma, Italy. george.georges@chiesi.com.'}]",Respiratory research,['10.1186/s12931-021-01683-2']
634,33766992,Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy.,"OBJECTIVE


This is the first double-blind randomized controlled trial evaluating the efficacy and safety of IV immunoglobulin (IVIG) vs placebo in patients with idiopathic small fiber neuropathy (I-SFN).
METHODS


Between July 2016 and November 2018, 60 Dutch patients with skin biopsy-proven I-SFN randomly received a starting dose of IVIG (2 g/kg body weight) or matching placebo (0.9% saline). Subsequently, 3 additional infusions of IVIG (1 g/kg) or placebo were administered at 3-week intervals. The primary outcome was a 1-point change in Pain Intensity Numerical Rating Scale score at 12 weeks compared to baseline.
RESULTS


Thirty patients received IVIG, and 30 received placebo. In both groups, 29 patients completed the trial. In 40% of patients receiving IVIG, the mean average pain was decreased by at least 1 point compared to 30% of the patients receiving placebo ( p  = 0.588, odds ratio 1.56, 95% confidence interval 0.53-4.53). No significant differences were found on any of the other prespecified outcomes, including general well-being, autonomic symptoms, and overall functioning and disability.
CONCLUSIONS


This randomized controlled trial showed that IVIG treatment had no significant effect on pain in patients with painful I-SFN.
TRIAL REGISTRATION INFORMATION


ClinicalTrials.gov Identifier: NCT02637700, EudraCT 2015-002624-31.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that for patients with painful I-SFN, IVIG did not significantly reduce pain compared to placebo.",2021,"No significant differences were found on any of the other pre-specified outcomes including general wellbeing, autonomic symptoms, and overall functioning and disability.
","['patients with painful idiopathic SFN', 'Patients With Painful Idiopathic Small Fiber Neuropathy', '29 patients completed the trial', 'patients with idiopathic small fiber neuropathy (I-SFN', '60 Dutch patients with skin-biopsy proven idiopathic SFN', 'Between July 2016 and November 2018', 'Thirty patients received IVIg, and 30 received']","['matching placebo', 'placebo', 'intravenous immunoglobulin (IVIg) versus placebo', 'Intravenous Immunoglobulin Therapy']","['pain', 'mean average pain', '1-point change in Pain Intensity Numerical Rating Scale (PI-NRS', 'general wellbeing, autonomic symptoms, and overall functioning and disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0972212', 'cui_str': 'SFN protein, human'}, {'cui': 'C3276706', 'cui_str': 'Small fiber neuropathy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",60.0,0.583999,"No significant differences were found on any of the other pre-specified outcomes including general wellbeing, autonomic symptoms, and overall functioning and disability.
","[{'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Geerts', 'Affiliation': 'From the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.'}, {'ForeName': 'Bianca T A', 'Initials': 'BTA', 'LastName': 'de Greef', 'Affiliation': 'From the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Sopacua', 'Affiliation': 'From the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.'}, {'ForeName': 'Sander M J', 'Initials': 'SMJ', 'LastName': 'van Kuijk', 'Affiliation': 'From the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.'}, {'ForeName': 'Janneke G J', 'Initials': 'JGJ', 'LastName': 'Hoeijmakers', 'Affiliation': 'From the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.'}, {'ForeName': 'Catharina G', 'Initials': 'CG', 'LastName': 'Faber', 'Affiliation': 'From the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao. c.faber@mumc.nl.'}, {'ForeName': 'Ingemar S J', 'Initials': 'ISJ', 'LastName': 'Merkies', 'Affiliation': 'From the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.'}]",Neurology,['10.1212/WNL.0000000000011919']
635,33772456,Efficacy of combining pentoxiphylline and vitamin E versus vitamin E alone in non-alcoholic steatohepatitis- A randomized pilot study.,"BACKGROUND AND AIM


Non-alcoholic steatohepatitis (NASH) is the most prevalent cause of chronic liver disease. Vitamin E (VE), an anti-oxidant, has shown improvement in NAFLD activity score (NAS) but not fibrosis. Pentoxiphylline (PTX), an anti-TNF-alpha agent, has been reported to reduce hepatic inflammation and fibrosis. We evaluated combination of these drugs in NASH patients.
METHODS


In a prospective study, consecutive histologically proven patients with NASH were randomized to receive either PTX, 400 mg thrice daily and VE 400 IU twice daily (group PTVE, n = 36) or VE alone (group VE, n = 33). Clinical, dietary and biochemical follow-up was done till 12 months. Primary end-point was change in alanine aminotransferase (ALT)  levels.   RESULTS: Both groups were comparable at baseline. On a strict diet and lifestyle modification regimen, both groups had similar reduction in body mass index and waist circumference. There was a similar reduction in ALT levels in the two groups. Metabolically, patients in PTVE group had greater reduction in fasting insulin levels and homeostatic model assessment of insulin resistance (HOMA-IR) than VE group (p = 0.05). Tumor necrosis factor alpha (TNFα) levels were also significantly lower in PTVE group from 6 months onwards. Twelve (10%) patients had repeat liver biopsy (7 in group PTVE, 5 in group VE) with no difference in reduction of NAS score (p = 0.45). However, there was a significant fibrosis regression in PTVE compared to VE group (p = 0.003).
CONCLUSIONS


These data show greater efficacy of a combination of PTX and VE in achieving fibrosis regression compared to VE alone with better metabolic homeostasis and amelioration of the pro-inflammatory status.
TRIAL REGISTRATION


Clinical Trials Registry no. NCT01384578.",2021,"However, there was a significant fibrosis regression in PTVE compared to VE group (p = 0.003).
","['non-alcoholic steatohepatitis', 'consecutive histologically proven patients with NASH', 'NASH patients']","['Vitamin E (VE', 'Pentoxiphylline (PTX', 'PTX, 400\xa0mg thrice daily and VE 400\xa0IU twice daily (group PTVE, n\u2009=\u200936) or VE alone', 'pentoxiphylline and vitamin E versus vitamin E alone']","['ALT levels', 'body mass index and waist circumference', 'NAS score', 'repeat liver biopsy', 'NAFLD activity score (NAS', 'alanine aminotransferase (ALT)\xa0 levels', 'Tumor necrosis factor alpha (TNFα) levels', 'fibrosis regression', 'fasting insulin levels and homeostatic model assessment of insulin resistance (HOMA-IR']","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.0776974,"However, there was a significant fibrosis regression in PTVE compared to VE group (p = 0.003).
","[{'ForeName': 'Chandan Kumar', 'Initials': 'CK', 'LastName': 'Kedarisetty', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, 110 070, India. drchandankn@gmail.com.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi 110 070, India.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi 110 070, India.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Pathology, Institute of Liver and Biliary Sciences, New Delhi 110 070, India.'}, {'ForeName': 'Chhagan', 'Initials': 'C', 'LastName': 'Bihari', 'Affiliation': 'Department of Pathology, Institute of Liver and Biliary Sciences, New Delhi 110 070, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, 110 070, India.'}, {'ForeName': 'Shiv Kumar', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, 110 070, India. shivsarin@gmail.com.'}]",Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology,['10.1007/s12664-020-01131-x']
636,33780173,"The impact of extracorporeal shock wave therapy for the treatment of young patients with vasculogenic mild erectile dysfunction: A prospective randomized single-blind, sham controlled study.","BACKGROUND


Low-intensity extracorporeal shock wave therapy (ESWT) for the treatment of vasculogenic erectile dysfunction (ED) has emerged as a promising method directly targeting the underlying pathophysiology of the disease.
OBJECTIVES


To compare outcomes in ED patients after ESWT and placebo treatment.
MATERIALS AND METHODS


Prospective randomized placebo-controlled single-blinded trial on 66 patients with mild ED. The study comprised a 4-week washout phase, a 4-week treatment phase, and a 48-week follow-up. Inclusion criteria included age between 18 and 75 years and diagnosis of mild ED (IIEF-EF score = 17-25) being made at least six months prior to study inclusion and being confirmed by Penile Doppler ultrasonography (US) at baseline examination. Efficacy endpoints were changes from baseline in patient-reported outcomes of erectile function (International Index of Erectile Function domain scores [IIEF-EF]), as well as erection hardness and duration (Sexual Encounter Profile diary [SEP] and Global Assessment Questions [GAQ]). Safety was assessed throughout the study.
RESULTS


A total of 66 enrolled patients were allocated to ESWT (n = 44) or placebo (n = 22). Mean age of ESWT and placebo group was 42.32 ± 9.88 and 39.86 ± 11.64 (p = 0.374), respectively. Mean baseline IIEF-EF scores of ESWT group and placebo were 20.32 ± 2.32 and 19.68 ± 1.55 respectively (p = 0.34). At 3-months follow-up, mean IIEF-EF scores were significantly higher in ESWT patients than in placebo patients (23.10 ± 2.82 vs. 20.95 ± 2.19, p = 0.003), and IIEF-EF scores of ESWT patients remained high during the 6 months (22.67 ± 3.35 vs. 19.82 ± 1.56) follow-up. The percentage of patients reporting both successful penetration (SEP2) and intercourse (SEP3) in more than 50% of attempts was significantly higher in ESWT-treated patients than in placebo patients (p = 0.001). A minimal clinically important difference between the IIEF = EF baseline and 3-months follow-up was found in 74% of ESWT and 36% of placebo. No serious adverse events were reported.
DISCUSSION AND CONCLUSION


ESWT significantly improved the erectile function of relatively young patients with vasculogenic mild ED when compared to placebo and the beneficial effect of this treatment up to 6 months. These findings suggest that ESWT could be a useful treatment option in vasculogenic ED.",2021,"At 3-months follow-up, mean IIEF-EF scores were significantly higher in ESWT patients than in placebo patients (23.10 ± 2.82 vs. 20.95 ± 2.19, p = 0.003), and IIEF-EF scores of ESWT patients remained high during the 6- months (22.67 ± 3.35 vs. 19.82 ± 1.56) follow-up.","['Young Patients with Vasculogenic Mild-Erectile Dysfunction (ED', '66 enrolled patients', 'ED patients after ESWT and placebo treatment', '66 patients with mild ED', 'vasculogenic erectile dysfunction (ED', 'Inclusion criteria included age between 18 and 75 years and diagnosis of mild ED (IIEF-EF score= 17-25) being made at least six months prior to study inclusion and being confirmed by Penile Doppler ultrasonography (US) at baseline examination']","['Extracorporeal Shock Wave Therapy (ESWT', 'placebo', 'Low-intensity extracorporeal shock wave therapy (ESWT', 'ESWT']","['percentage of patients reporting both successful penetration (SEP2) and intercourse (SEP3', 'erectile function', 'Safety', 'mean IIEF-EF scores', 'IIEF-EF scores', 'Mean baseline IIEF-EF scores', 'serious adverse events', 'erectile function(International Index of Erectile Function domain scores [IIEF-EF]), as well as erection hardness and duration (Sexual Encounter Profile diary [SEP] and Global Assessment Questions [GAQ']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",66.0,0.317102,"At 3-months follow-up, mean IIEF-EF scores were significantly higher in ESWT patients than in placebo patients (23.10 ± 2.82 vs. 20.95 ± 2.19, p = 0.003), and IIEF-EF scores of ESWT patients remained high during the 6- months (22.67 ± 3.35 vs. 19.82 ± 1.56) follow-up.","[{'ForeName': 'Mazhar', 'Initials': 'M', 'LastName': 'Ortac', 'Affiliation': 'Urology Department, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Abdulkadir', 'Initials': 'A', 'LastName': 'Özmez', 'Affiliation': 'Urology Department, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Nusret Can', 'Initials': 'NC', 'LastName': 'Cilesiz', 'Affiliation': 'Urology Department, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Demirelli', 'Affiliation': 'Urology Department, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Ateş', 'Initials': 'A', 'LastName': 'Kadıoğlu', 'Affiliation': 'Urology Department, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}]",Andrology,['10.1111/andr.13007']
637,33778945,"Effects of methylphenidate on executive functioning in children and adolescents with ADHD after long-term use: a randomized, placebo-controlled discontinuation study.","BACKGROUND


Methylphenidate may improve executive functioning in children with attention-deficit/hyperactivity disorder (ADHD). However, it is unclear if there are still acute effects of methylphenidate on executive functioning after long-term use.
METHODS


In a randomized double-blind, placebo-controlled discontinuation study, 94 children and adolescents (ages 8-18 years) who used methylphenidate beyond two years were either assigned to seven weeks of continued treatment with 36 or 54 mg of extended-release methylphenidate or to gradual withdrawal over three weeks to placebo for four weeks. Performance on neuropsychological tasks, measuring working memory, response inhibition, attentional flexibility and psychomotor speed was compared between both groups using mixed models for repeated measures. Additionally, we investigated within the discontinuation group if a deterioration on the investigator-rated Clinical Global Impressions Improvement scale after withdrawing to placebo was related to a worse performance on the neuropsychological tasks. This study was registered in the Netherlands Trial Register (www. Trialregister.nl) with identifier 5252.
RESULTS


After withdrawal of methylphenidate, the discontinuation group made more errors on working memory (β = -1.62, SD = 0.56, t = -2.88, p = .01, Cohen's f2 = .14), independent from reaction time compared to baseline, in contrast to the continuation group. We did not find differences in changes in response inhibition, attentional flexibility and psychomotor speed between the two groups. Also, there were no significant differences in task measures between the participants who deteriorated clinically and those who did not.
CONCLUSIONS


Our study shows that methylphenidate has a beneficial effect on working memory after two years of use. Future studies should explore whether cognitive outcomes may aid clinical decision-making on the continued use of methylphenidate, given dissociation between cognitive and behavioural effects of stimulant medication.",2021,"Performance on neuropsychological tasks, measuring working memory, response inhibition, attentional flexibility and psychomotor speed was compared between both groups using mixed models for repeated measures.","['children with attention-deficit/hyperactivity disorder (ADHD', '94 children and adolescents (ages 8-18\xa0years) who used methylphenidate beyond two years', 'Netherlands Trial Register (www. Trialregister.nl) with identifier 5252', 'children and adolescents with ADHD after long-term use']","['placebo', 'methylphenidate', 'Methylphenidate']","['response inhibition, attentional flexibility and psychomotor speed', 'investigator-rated Clinical Global Impressions Improvement scale', 'neuropsychological tasks, measuring working memory, response inhibition, attentional flexibility and psychomotor speed', 'errors on working memory (β\xa0', 'executive functioning', 'task measures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",94.0,0.222612,"Performance on neuropsychological tasks, measuring working memory, response inhibition, attentional flexibility and psychomotor speed was compared between both groups using mixed models for repeated measures.","[{'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Rosenau', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Thaïra J C', 'Initials': 'TJC', 'LastName': 'Openneer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anne-Flore M', 'Initials': 'AM', 'LastName': 'Matthijssen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gigi H H', 'Initials': 'GHH', 'LastName': 'van de Loo-Neus', 'Affiliation': 'Karakter Child and Adolescent Psychiatry Center Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': 'Karakter Child and Adolescent Psychiatry Center Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'van den Hoofdakker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dietrich', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13419']
638,33779579,Melancholic Features in Bipolar Depression and Response to Lamotrigine: A Pooled Analysis of Five Randomized Placebo-Controlled Trials.,"BACKGROUND


A pilot study suggested lamotrigine may be more effective for bipolar depression with melancholic features. We tested this hypothesis in a pooled analysis of 5 randomized double-blind placebo-controlled trials of lamotrigine for acute bipolar depression.
METHODS


The pooled sample consisted of 1072 adult outpatients. Depressive symptoms were assessed for 7 to 10 weeks with the Hamilton Depression Rating Scale and the Montgomery-Åsberg Depression Rating Scale. The outcome measure was end-trial response (score reduction ≥ 50%). Melancholic features were assessed with both the Structured Clinical Interview for DSM-IV and baseline depression scale items, according to DSM criteria.
RESULTS


The item-based melancholic specifier was associated with numerically larger treatment effects, although subgroup-treatment interactions in logistic regression models did not reach statistical significance. The small subgroup of patients with severe psychomotor retardation also appeared to benefit from lamotrigine. However, the Structured Clinical Interview for DSM-IV melancholic specifier was not associated with larger treatment effects. Baseline depression severity was inconsistently associated with response, depending on which scale was used to define severity. The 2 melancholia variables had poor agreement despite having similar prevalences.
CONCLUSIONS


Our results do not clearly support the original hypothesis but do reinforce the importance of replicating secondary analyses of clinical trials with additional data.",2021,"The item-based melancholic specifier was associated with numerically larger treatment effects, although subgroup-treatment interactions in logistic regression models did not reach statistical significance.",['1072 adult outpatients'],"['Placebo', 'placebo', 'Lamotrigine', 'lamotrigine']","['Baseline depression severity', 'Depressive symptoms', 'Structured Clinical Interview for DSM-IV and baseline depression scale items', 'Hamilton Depression Rating Scale and the Montgomery-Åsberg Depression Rating Scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",1072.0,0.337663,"The item-based melancholic specifier was associated with numerically larger treatment effects, although subgroup-treatment interactions in logistic regression models did not reach statistical significance.","[{'ForeName': 'Evyn M', 'Initials': 'EM', 'LastName': 'Peters', 'Affiliation': 'From the Department of Psychiatry, University of Saskatchewan, Saskatoon, SK.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Lodhi', 'Affiliation': 'From the Department of Psychiatry, University of Saskatchewan, Saskatoon, SK.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'College of Nursing, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Balbuena', 'Affiliation': 'From the Department of Psychiatry, University of Saskatchewan, Saskatoon, SK.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001393']
639,33795324,Continuous positive airway pressure improves blood pressure and serum cardiovascular biomarkers in obstructive sleep apnoea and hypertension.,"BACKGROUND


The impact of treatment for obstructive sleep apnoea (OSA) on reduction of cardiovascular risk is unclear. This study aimed to examine the effect of continuous positive airway pressure (CPAP) on ambulatory blood pressure (BP) and subclinical myocardial injury in subjects with OSA and hypertension.
METHODS


This was a parallel-group randomised controlled trial. Subjects with hypertension requiring at least three antihypertensive medications and moderate-to-severe OSA were enrolled. Eligible subjects were randomised (1:1) to receive either CPAP treatment or control (no CPAP) for 8 weeks. Changes in ambulatory BP and serum biomarkers were compared. Stratified analysis according to circadian BP pattern was performed.
RESULTS


92 subjects (75% male; mean±sd age 51±8 years and apnoea-hypopnoea index 40±8 events·h -1 , taking an average of 3.4 (range 3-6) antihypertensive drugs) were randomised. The group on CPAP treatment, compared with the control group, demonstrated a significant reduction in 24-h systolic BP (-4.4 (95% CI -8.7- -0.1) mmHg; p=0.046), 24-h diastolic BP (-2.9 (95% CI -5.5- -0.2) mmHg; p=0.032), daytime systolic BP (-5.4 (95% CI -9.7- -1.0) mmHg; p=0.016) and daytime diastolic BP (-3.4 (95% CI -6.1- -0.8) mmHg; p=0.012). CPAP treatment was associated with significant BP lowering only in nondippers, but not in dippers. Serum troponin I (mean difference -1.74 (95% CI -2.97- -0.50) pg·mL -1 ; p=0.006) and brain natriuretic peptide (-9.1 (95% CI -17.6- -0.6) pg·mL -1 ; p=0.036) were significantly reduced in CPAP compared with the control group.
CONCLUSIONS


In a cohort with OSA and multiple cardiovascular risk factors including difficult-to-control hypertension, short-term CPAP treatment improved ambulatory BP, and alleviated subclinical myocardial injury and strain.",2021,Serum troponin I (mean difference -1.74 ,"['Ninety', 'obstructive sleep apnoea (OSA', 'subjects with OSA and hypertension', 'two subjects (75% men; age, 51±8\u2005years; apnoea-hypopnoea index 40±8', 'Subjects with hypertension requiring at least three anti-hypertensive medications and moderate-severe OSA were enrolled', 'obstructive sleep apnoea and hypertension', 'Eligible subjects']","['Continuous positive airway pressure', 'CPAP treatment or control (no CPAP', 'CPAP', 'continuous positive airway pressure (CPAP']","['Serum troponin I', 'ambulatory BP and alleviated subclinical myocardial injury and strain', 'daytime diastolic BP ', 'brain natriuretic peptide', 'CPAP', 'ambulatory blood pressure (BP', '24-h systolic BP', 'daytime systolic BP', 'ambulatory BP and serum biomarkers', 'BP lowering', '24-h diastolic BP', 'blood pressure and serum cardiovascular biomarkers']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.103109,Serum troponin I (mean difference -1.74 ,"[{'ForeName': 'Macy Mei-Sze', 'Initials': 'MM', 'LastName': 'Lui', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, Dept of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Hung-Fat', 'Initials': 'HF', 'LastName': 'Tse', 'Affiliation': 'Division of Cardiology, Dept of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'David Chi-Leung', 'Initials': 'DC', 'LastName': 'Lam', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, Dept of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Kui-Kai', 'Initials': 'KK', 'LastName': 'Lau', 'Affiliation': 'Division of Neurology, Dept of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Carmen Wing-Sze', 'Initials': 'CW', 'LastName': 'Chan', 'Affiliation': 'Division of Cardiology, Dept of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Mary Sau-Man', 'Initials': 'MS', 'LastName': 'Ip', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, Dept of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong msmip@hku.hk.'}]",The European respiratory journal,['10.1183/13993003.03687-2020']
640,33778854,A Brief Motivational Intervention Differentially Reduces Sugar-sweetened Beverage (SSB) Consumption.,"BACKGROUND


Environmental and behavioral interventions hold promise to reduce sugar-sweetened beverage (SSBs) consumption.
PURPOSE


To test, among frequent SSB consumers, whether motivations to consume SSBs moderated the effects of (a) a workplace SSB sales ban (environmental intervention) alone, and (b) a ""brief motivational intervention"" (BI) in addition to the sales ban, on changes in SSB consumption.
METHODS


We assessed whether (1) baseline motivations to consume SSBs (craving, psychological stress, or taste enjoyment) impacted changes in daily SSB consumption at 6-month follow-up among frequent (>12oz of SSBs/day) SSB consumers (N = 214); (2) participants randomized to the BI (n = 109) versus to the sales ban only (n = 105) reported greater reductions in SSB consumption at follow-up; and (3) motivations to consume SSBs moderated any changes in SSB consumption.
RESULTS


In response to the sales ban alone, individuals with stronger SSB cravings (+1 SD) at baseline showed significantly smaller reductions in daily SSB consumption at 6-month follow-up relative to individuals with weaker (-1 SD) SSB cravings (2.5 oz vs. 22.5 oz), p < .01. Receiving the BI significantly increased reductions for those with stronger SSB cravings: Among individuals with stronger cravings, those who received the BI evidenced significantly greater reductions in daily SSB consumption [M(SE) = -19.2 (2.74) oz] than those who did not [M(SE) = -2.5 (2.3) oz, p < .001], a difference of 16.72 oz.
CONCLUSIONS


Frequent SSB consumers with stronger SSB cravings report minimal reductions in daily SSB consumption with a sales ban only, but report greater reductions if they also receive a motivational intervention. Future multilevel interventions for institutions should consider both environmental and individualized multi-level interventions.
CLINICAL TRIAL INFORMATION


NCT02585336.",2021,"Receiving the BI significantly increased reductions for those with stronger SSB cravings: Among individuals with stronger cravings, those who received the BI evidenced significantly greater reductions in daily SSB consumption [M(SE) =",['SSB consumers (N = 214'],[],"['daily SSB consumption', 'SSB consumption', 'SSB cravings', 'daily SSB consumption [M(SE) ', 'SSBs (craving, psychological stress, or taste enjoyment) impacted changes in daily SSB consumption', 'Sugar-sweetened Beverage (SSB) Consumption']",[],[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}]",214.0,0.153469,"Receiving the BI significantly increased reductions for those with stronger SSB cravings: Among individuals with stronger cravings, those who received the BI evidenced significantly greater reductions in daily SSB consumption [M(SE) =","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco (UCSF), San Francisco, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schmidt', 'Affiliation': 'Phillip R. Lee Institute for Health Policy Studies, UCSF, San Francisco, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ishkanian', 'Affiliation': 'Campus Life Services, UCSF Wellness Program, UCSF, San Francisco, USA.'}, {'ForeName': 'Laurie M', 'Initials': 'LM', 'LastName': 'Jacobs', 'Affiliation': 'Phillip R. Lee Institute for Health Policy Studies, UCSF, San Francisco, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Leung', 'Affiliation': 'Department of Nutritional Sciences, School of Public Health, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Leeane', 'Initials': 'L', 'LastName': 'Jensen', 'Affiliation': 'Campus Life Services, UCSF Wellness Program, UCSF, San Francisco, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cohn', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco (UCSF), San Francisco, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Schleicher', 'Affiliation': 'Department of Medicine, University of Maryland, College Park, USA.'}, {'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Hartman', 'Affiliation': 'Department of Psychology, College of Arts & Sciences, Drexel University, Philadelphia, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Wojcicki', 'Affiliation': 'Department of Pediatrics, UCSF, San Francisco, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lustig', 'Affiliation': 'Phillip R. Lee Institute for Health Policy Studies, UCSF, San Francisco, USA.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco (UCSF), San Francisco, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa123']
641,33774892,An integrative healthcare model with heartfulness meditation and care coordination improves outcomes in cyclic vomiting syndrome.,"BACKGROUND


Cyclic vomiting syndrome (CVS) is associated with psychosocial comorbidity and often triggered by stress. Since the current disease-centered care model does not address psychosocial factors, we hypothesized that holistic, patient-centered care integrating meditation and addressing psychosocial needs through a care coordinator will improve healthcare outcomes in CVS.
METHODS


We conducted a prospective randomized controlled trial: 49 patients with CVS (mean age: 34 ± 14 years; 81% female) were randomized to conventional health care (controls) or Integrative Health care (IHC) (27: controls, 22: IHC). The IHC group was assigned a care coordinator and received meditation with a certified instructor. Outcomes including psychological distress, coping strategies to manage chronic stress, cognitive symptom management, and Health-Related Quality of Life (HRQoL) were measured.
KEY RESULTS


In intention-to-treat analyses, patients receiving IHC showed significant improvement in multiple domains of coping including positive reframing, planning, and reduction in self-blame (p values ≤0.05), and physical HRQoL (p = 0.03) at 6 months. They also leaned toward spirituality/religion as a coping measure (p ≤ 0.02 at 3 and 6 months). Subgroup analysis of compliant patients showed additional benefit with significant reduction in psychological distress (p = 0.04), improvement in sleep quality (p = 0.03), reduction in stress levels (0.02), improvement in physical HRQoL (0.04), and further improvement in other domains of coping (p < 0.05).
CONCLUSIONS AND INFERENCES


An IHC model incorporating meditation and care coordination improves patient outcomes in CVS and is a useful adjunct to standard treatment. Studies to determine the independent effects of meditation and care coordination are warranted.",2021,"In intention-to-treat analyses, patients receiving IHC showed significant improvement in multiple domains of coping including positive reframing, planning, and reduction in self-blame (p values ≤0.05), and physical HRQoL (p = 0.03) at 6 months.",['49 patients with CVS (mean age: 34\xa0±\xa014\xa0years; 81% female'],"['heartfulness meditation and care coordination', 'conventional health care (controls) or Integrative Health care (IHC', 'care coordinator and received meditation with a certified instructor']","['sleep quality', 'psychological distress', 'physical HRQoL', 'psychological distress, coping strategies to manage chronic stress, cognitive symptom management, and Health-Related Quality of Life (HRQoL', 'multiple domains of coping including positive reframing, planning, and reduction in self-blame', 'cyclic vomiting syndrome', 'reduction in stress levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152164', 'cui_str': 'Cyclical vomiting syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C4708569', 'cui_str': 'Care coordinator'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0152164', 'cui_str': 'Cyclical vomiting syndrome'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",49.0,0.0887831,"In intention-to-treat analyses, patients receiving IHC showed significant improvement in multiple domains of coping including positive reframing, planning, and reduction in self-blame (p values ≤0.05), and physical HRQoL (p = 0.03) at 6 months.","[{'ForeName': 'Thangam', 'Initials': 'T', 'LastName': 'Venkatesan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Porcelli', 'Affiliation': 'Department of Psychology, Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'Anagha', 'Initials': 'A', 'LastName': 'Matapurkar', 'Affiliation': 'Heartfulness Institute, Austin, TX, USA.'}, {'ForeName': 'Vishnu Charan', 'Initials': 'VC', 'LastName': 'Suresh Kumar', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Szabo', 'Affiliation': 'Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wieloch', 'Affiliation': 'Froedtert Hospital, Milwaukee, WI, USA.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14132']
642,33793282,Differential mechanisms of change in motivational interviewing versus health education for smoking cessation induction.,"Objective:  To determine if Motivational Interviewing (MI) versus health education (HE) elicited different types of client language and whether these differences were associated with outcomes in a randomized clinical trial (RCT) for cessation induction among people who smoke with low motivation to quit.  Methods:  A secondary data analysis was conducted using data from the MI and HE arms of a trial in which people who smoke ( N  = 202) with low desire to quit were randomly assigned to four sessions of MI, HE or brief advice. Mediation analyses examined two types of client language: change talk (CT) and a novel form of client speech called ""learning talk"" (LT). Outcomes were assessed at baseline, 3 and 6 months.  Results:  With HE as the reference group, MI resulted in greater CT ( OR  = 3.0, 95% CI: 1.7-5.5) which was associated with better outcomes (average  d  = .34,  SD  = .13) and HE resulted in greater LT ( OR  = .05, 95% CI: .02-.10) which was also associated with better outcomes (average  d  = .42,  SD  = .08). Indirect parallel mediation effects on quit attempts were significant for both MI-CT ( OR  = 1.4, 95% CI: 1.1-1.7) and HE-LT ( OR  = .4, 95% CI: .2-.7).  Conclusions:  MI and HE were both efficacious via different pathways to change, confirming the utility of MI in this RCT as well as highlighting the potential of HE based on the ""5R's"" for smoking cessation. These findings emphasize the value of exploring theorized mechanisms of action of interventions evaluated in RCTs. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Indirect parallel mediation effects on quit attempts were significant for both MI-CT ( OR  = 1.4, 95% CI: 1.1-1.7) and HE-LT ( OR  = .4, 95% CI: .2-.7).  ","['people who smoke ( N  = 202) with low desire to quit', 'people who smoke with low motivation to quit']","['client language: change talk (CT) and a novel form of client speech called ""learning talk"" (LT', 'Motivational Interviewing (MI) versus health education (HE', 'motivational interviewing versus health education', 'MI, HE or brief advice']",['quit attempts'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0558078', 'cui_str': 'Low motivation'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]",[],,0.261405,"Indirect parallel mediation effects on quit attempts were significant for both MI-CT ( OR  = 1.4, 95% CI: 1.1-1.7) and HE-LT ( OR  = .4, 95% CI: .2-.7).  ","[{'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Grobe', 'Affiliation': 'JEGrobe Consulting.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Moreno', 'Affiliation': 'Department of Psychiatry and Behavioral Health.'}, {'ForeName': 'Saige', 'Initials': 'S', 'LastName': 'Stortz', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Fox', 'Affiliation': 'Hoglund Biomedical Imaging Center.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': 'Division of Health Services and Outcomes Research.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Preventive Medicine and Public Health.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior and Health Education.'}, {'ForeName': 'Kari J', 'Initials': 'KJ', 'LastName': 'Harris', 'Affiliation': 'School of Public and Community Health Sciences.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': 'Division of Health Services and Outcomes Research.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000720']
643,33785743,Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial.,"Type III interferons have been touted as promising therapeutics in outpatients with coronavirus disease 2019 (COVID-19). We conducted a randomized, single-blind, placebo-controlled trial (NCT04331899) in 120 outpatients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) within 72 hours of diagnosis could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint). In both the 60 patients receiving Lambda and 60 receiving placebo, the median time to cessation of viral shedding was 7 days (hazard ratio [HR] = 0.81; 95% confidence interval [CI] 0.56 to 1.19). Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39). Both Lambda and placebo were well-tolerated, though liver transaminase elevations were more common in the Lambda vs. placebo arm (15/60 vs 5/60; p = 0.027). In this study, a single dose of subcutaneous Peginterferon Lambda-1a neither shortened the duration of SARS-CoV-2 viral shedding nor improved symptoms in outpatients with uncomplicated COVID-19.",2021,"Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39).","['60 patients receiving Lambda and 60 receiving', '120 outpatients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) within 72 hours of diagnosis could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint', 'outpatients with uncomplicated COVID-19', 'outpatients with coronavirus disease 2019 (COVID-19']","['placebo', 'Peginterferon Lambda-1a', 'subcutaneous Peginterferon Lambda-1a']","['symptom duration', 'median time to cessation of viral shedding', 'tolerated', 'liver transaminase elevations', 'duration of SARS-CoV-2 viral shedding nor improved symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1720314', 'cui_str': 'Lambda'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4043002', 'cui_str': 'peginterferon lambda-1a'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4043002', 'cui_str': 'peginterferon lambda-1a'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",120.0,0.505733,"Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39).","[{'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA. prasj@stanford.edu.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Andrews', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Bonilla', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Hedlin', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Jacobson', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Vidhya', 'Initials': 'V', 'LastName': 'Balasubramanian', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Purington', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Kamble', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Christiaan R', 'Initials': 'CR', 'LastName': 'de Vries', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Quintero', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Feng', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ley', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Winslow', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Newberry', 'Affiliation': 'Department of Emergency Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Karlie', 'Initials': 'K', 'LastName': 'Edwards', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Hislop', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Choong', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Maldonado', 'Affiliation': 'Eiger BioPharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Glenn', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Bhatt', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Blish', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Taia', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Chaitan', 'Initials': 'C', 'LastName': 'Khosla', 'Affiliation': 'ChEM-H, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Pinsky', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Upinder', 'Initials': 'U', 'LastName': 'Singh', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA. usingh@stanford.edu.'}]",Nature communications,['10.1038/s41467-021-22177-1']
644,33813110,Hydroxychloroquine in mild-to-moderate coronavirus disease 2019: a placebo-controlled double blind trial.,"OBJECTIVES


To determine whether hydroxychloroquine decreases the risk of adverse outcome in patients with mild to moderate coronavirus disease 2019 (COVID-19) at high risk of worsening.
METHODS


We conducted a multicentre randomized double-blind placebo-controlled trial evaluating hydroxychloroquine in COVID-19 patients with at least one of the following risk factors for worsening: need for supplemental oxygen, age ≥75 years, age between 60 and 74 years and presence of at least one co-morbidity. Severely ill patients requiring oxygen therapy >3 L/min or intensive care were excluded. Eligible patients were randomized in a 1:1 ratio to receive either 800 mg hydroxychloroquine on day 0 followed by 400 mg per day for 8 days or a placebo. The primary end point was a composite of death or start of invasive mechanical ventilation within 14 days following randomization. Secondary end points included mortality and clinical evolution at days 14 and 28, and viral shedding at days 5 and 10.
RESULTS


The trial was stopped after 250 patients were included because of a slowing down of the pandemic in France. The intention-to-treat population comprised 123 and 124 patients in the placebo and hydroxychloroquine groups, respectively. The median age was 77 years (interquartile range 58-86 years) and 151/250 (60.4%) patients required oxygen therapy. The primary end point occurred in 9/124 (7.3%) patients in the hydroxychloroquine group and 8/123 (6.5%) patients in the placebo group (relative risk 1.12; 95% CI 0.45-2.80). The rates of positive SARS-CoV-2 RT-PCR tests at days 5 and 10 were 72.8% (75/103) and 57.1% (52/91) in the hydroxychloroquine group, versus 73.0% (73/100) and 56.6% (47/83) in the placebo group, respectively. No difference was observed between the two groups in any of the other secondary end points.
CONCLUSION


In this underpowered trial involving mainly older patients with mild to moderate COVID-19, patients treated with hydroxychloroquine did not experience better clinical or virological outcomes than those receiving the placebo.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04325893 (https://clinicaltrials.gov/ct2/show/NCT04325893).",2021,"The rate of positive SARS-CoV-2 RT-PCR at day 5 and 10 was 72.8% (75/103) and 57.1% (52/91) in the hydroxychloroquine group, versus 73.0% (73/100) and 56.6% (47/83) in the placebo group, respectively.","['mainly older patients with mild-to-moderate COVID-19, patients treated with', 'Eligible patients', 'patients with mild-to-moderate COVID-19 at high risk of worsening', 'COVID-19 patients with at least one of the following risk factors for worsening: need for supplemental oxygen, age ≥75\xa0years, age between 60 - 74\xa0years and presence of at least one comorbidity', 'mild-to-moderate COVID-19', 'The median age was 77 (interquartile range 58 - 86) years and 151/250 (60.4', '250 patients were included due to a slowdown of the pandemic in France', 'Severely ill patients requiring oxygen therapy > 3L/min or intensive care were excluded']","['oxygen therapy', 'placebo', 'placebo and hydroxychloroquine', 'Hydroxychloroquine', 'hydroxychloroquine']","['mortality and clinical evolution at Day 14 and 28, viral shedding at Day 5 and 10', 'composite of death or start of invasive mechanical ventilation', 'rate of positive SARS-CoV-2 RT-PCR', 'virological outcomes', 'risk of adverse outcome']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",250.0,0.824461,"The rate of positive SARS-CoV-2 RT-PCR at day 5 and 10 was 72.8% (75/103) and 57.1% (52/91) in the hydroxychloroquine group, versus 73.0% (73/100) and 56.6% (47/83) in the placebo group, respectively.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Dubée', 'Affiliation': ""Service des Maladies Infectieuses et Tropicales, CHU d'Angers, Angers, France; CRCINA, Inserm, Université de Nantes, Université d'Angers, Angers, France. Electronic address: vincent.dubee@chu-angers.fr.""}, {'ForeName': 'Pierre-Marie', 'Initials': 'PM', 'LastName': 'Roy', 'Affiliation': ""Emergency Department, CHU d'Angers, Angers, France; Institut MitoVasc, UMR CNRS 6215 INSERM 1083, Université d'Angers, Angers, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vielle', 'Affiliation': ""Biostatistics and Methodology Department, Maison de La Recherche, CHU d'Angers, Angers, France.""}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Parot-Schinkel', 'Affiliation': ""Biostatistics and Methodology Department, Maison de La Recherche, CHU d'Angers, Angers, France.""}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Blanchet', 'Affiliation': ""Centre de Ressources Biologiques, BB-0033-00038, CHU d'Angers, Angers, France.""}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Darsonval', 'Affiliation': ""Service Pharmacie, CHU d'Angers, Angers, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lefeuvre', 'Affiliation': 'Département des Agents Infectieux, Laboratoire de Virologie, CHU Angers, Angers, France.'}, {'ForeName': 'Chadi', 'Initials': 'C', 'LastName': 'Abbara', 'Affiliation': ""Laboratoire de Pharmacologie-toxicologie, CHU d'Angers, Angers, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Boucher', 'Affiliation': ""Institut MitoVasc, UMR CNRS 6215 INSERM 1083, Université d'Angers, Angers, France; Service d'ORL et Chirurgie Cervico-faciale, CHU d'Angers, Angers, France.""}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Devaud', 'Affiliation': 'Service de Médecine Interne et Maladies Infectieuses, CH R. Dubos, Pontoise, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Robineau', 'Affiliation': 'Service Universitaire des Maladies Infectieuses et du Voyageur, CH de Tourcoing, Tourcoing, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rispal', 'Affiliation': 'Service de Médecine Interne, CH Agen, Agen, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Guimard', 'Affiliation': 'Service de Médecine Post-urgence, CH Départemental de Vendée, La Roche sur Yon, France.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': ""d'Anglejean"", 'Affiliation': 'Service de Médecine Interne et Maladies Infectieuses, CH Versailles-Hôpital André Mignot, Le Chesnay, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Diamantis', 'Affiliation': 'Service de Médecine Polyvalente et Maladies Infectieuses, Groupe Hospitalier Sud Ile de France, Melun, France.'}, {'ForeName': 'Marc-Antoine', 'Initials': 'MA', 'LastName': 'Custaud', 'Affiliation': ""Institut MitoVasc, UMR CNRS 6215 INSERM 1083, Université d'Angers, Angers, France; Centre de Recherche Clinique, CHU d'Angers, Angers, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Pellier', 'Affiliation': ""Unité d'hématologie et d'oncologie Pédiatrique, CHU d'Angers, Inserm U1232-CRCINA, Université d'Angers, Angers, France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Mercat', 'Affiliation': ""Département de Médecine Intensive-Réanimation, CHU d'Angers, Université d'Angers, Angers, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2021.03.005']
645,33813530,Pediatric Education Discharge Support Strategies for Newly Diagnosed Children With Cancer.,"BACKGROUND


Discharge education practices vary among institutions and lack a standardized approach for newly diagnosed pediatric oncology patients and their parents.
OBJECTIVE


The purpose of this American Nurses Credentialing Center-supported pediatric multisite trial was to determine the feasibility and effectiveness of 2 nurse-led Parent Education Discharge Support Strategies (PEDSS) for families with a child who is newly diagnosed with cancer.
INTERVENTIONS/METHODS


A cluster randomized clinical trial design assigned 16 Magnet-designated sites to a symptom management PEDSS intervention or parent support and coping PEDSS intervention. Outcome measures evaluated at baseline, 1, and 2 months after diagnosis include symptom experiences, parent perceptions of care, unplanned service utilization, and parent evaluation of the PEDSS interventions.
RESULTS


There were 283 newly diagnosed children and their parent participating in this study. Linear mixed models revealed pain differed over time by the intervention; children in the symptom management group had a greater decrease in pain. Greater nausea and appetite disturbances were experienced by older children in both groups. Fatigue and sleep disturbance showed a significant decrease over time in both groups. The symptom management group reported significantly greater satisfaction with the PEDSS intervention.
CONCLUSIONS


This study is among the first to examine the effects of 2 different early-discharge planning strategies for families of a newly diagnosed child with cancer. The evidence supports a standardized discharge education strategy that can be successfully implemented across institutions.
IMPLICATIONS FOR PRACTICE


Nurses play a major role in the educational preparation and discharge of newly diagnosed pediatric cancer patients and their families.",2021,Linear mixed models revealed pain differed over time by the intervention; children in the symptom management group had a greater decrease in pain.,"['families of a newly diagnosed child with cancer', 'newly diagnosed pediatric oncology patients and their parents', 'families with a child who is newly diagnosed with cancer', 'newly diagnosed pediatric cancer patients and their families', '283 newly diagnosed children and their parent participating in this study', 'Newly Diagnosed Children With Cancer']","['symptom management PEDSS intervention or parent support and coping PEDSS intervention', '2 nurse-led Parent Education Discharge Support Strategies (PEDSS']","['Fatigue and sleep disturbance', 'pain', 'nausea and appetite disturbances', 'symptom experiences, parent perceptions of care, unplanned service utilization, and parent evaluation of the PEDSS interventions']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",283.0,0.0910092,Linear mixed models revealed pain differed over time by the intervention; children in the symptom management group had a greater decrease in pain.,"[{'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Hockenberry', 'Affiliation': ""Author Affiliations: Duke University School of Nursing, Durham, North Carolina (Drs Hockenberry and Hatch and Ms Arthur); Ann & Robert H. Lurie Children's Hospital of Chicago, Illinois (Ms Haugen and Ms Coyne); Cohen Children's Medical Center, New Hyde Park, New York (Ms Slaven); Nationwide Children's Hospital, Columbus, Ohio (Dr Skeens); Children's Health System of Texas Children's Medical Center, Dallas, Texas (Ms Patton); American Family Children's Hospital, University of Wisconsin Health, Madison (Dr Montgomery); Northwestern Medicine Central DuPage Hospital, Chicago, Illinois (Ms Trimble); St Jude Children's Hospital, Memphis, Tennessee (Ms Hancock); King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia (Mr Ahmad); St Louis Children's Hospital, Washington University School of Medicine, Missouri (Ms Daut and Ms Glover); Levine Children's Hospital, Charlotte, North Carolina (Ms Brown); The Barbara Bush Children's Hospital at Maine Medical Center, Portland, Maine (Ms St Pierre); West Virginia University Medicine, Morgantown (Ms Shay); St Peter's University Hospital, New Brunswick, New Jersey (Ms Maloney); Nicklaus Children's Hospital, Miami, Florida (Ms Burke).""}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Haugen', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Slaven', 'Affiliation': ''}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Skeens', 'Affiliation': ''}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Patton', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Montgomery', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Trimble', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Coyne', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hancock', 'Affiliation': ''}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Daut', 'Affiliation': ''}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Glover', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Sherryann', 'Initials': 'S', 'LastName': 'St Pierre', 'Affiliation': ''}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Shay', 'Affiliation': ''}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Maloney', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Burke', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hatch', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Arthur', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000947']
646,33798654,Durability of Voretigene Neparvovec for Biallelic RPE65-Mediated Inherited Retinal Disease: Phase 3 Results at 3 and 4 Years.,"PURPOSE


To determine whether functional vision and visual function improvements after voretigene neparvovec (VN; Luxturna [Spark Therapeutics, Inc]) administration in patients with biallelic RPE65 mutation-associated inherited retinal disease are maintained at 3 to 4 years and to review safety outcomes.
DESIGN


Open-label, randomized, controlled phase 3 trial.
PARTICIPANTS


Thirty-one individuals were enrolled and randomized 2:1 to intervention (n = 21) or control (n = 10). One participant from each group withdrew before, or at, randomization.
METHODS


Patients in the original intervention (OI) group received bilateral subretinal VN injections. Delayed intervention (DI) patients served as control participants for 1 year then received VN.
MAIN OUTCOME MEASURES


Change from injection baseline in bilateral performance on the multiluminance mobility test (MLMT), a measure of ambulatory navigation, and change from injection baseline in full-field light sensitivity threshold white light, visual field (VF), and visual acuity (VA).
RESULTS


Mean bilateral MLMT change scores at year 4 for OI patients and year 3 for DI patients were 1.7 and 2.4, respectively, with 71% of patients with a year 3 visit able to pass MLMT at the lowest light level. Mean change in full-field light sensitivity threshold white light, averaged over both eyes at year 4 for OI patients and year 3 for DI patients, was -1.90 log 10 (cd.s/m 2 ) and -2.91 log 10 (cd.s/m 2 ), respectively. Mean change in Goldmann kinetic VF III4e sum total degrees, averaged across both eyes, was 197.7 at year 4 for OI patients and 157.9 at year 3 for DI patients. Mean change in VA (Holladay scale), averaged across both eyes, was -0.003 logarithm of the minimum angle of resolution (logMAR) at year 4 for OI patients and -0.06 logMAR at year 3 for DI patients. One OI patient experienced retinal detachment at approximately year 4 that impacted VA for the OI group. No product-related serious adverse events (AEs) occurred, nor did any deleterious immune responses.
CONCLUSIONS


Improvements in ambulatory navigation, light sensitivity, and VF were consistent in both intervention groups. Overall, improvements were maintained up to 3 to 4 years, with ongoing observation. The safety profile of VN was consistent with vitrectomy and the subretinal injection procedure and was similar between intervention groups, with no product-related serious AEs reported.",2021,"Mean bilateral MLMT change scores at Year 4 for OI subjects and at Year 3 for DI subjects were 1.7 and 2.4 respectively, with 71% of subjects with a Year 3 visit able to pass MLMT at the lowest light level.","['Subjects in the original intervention (OI) group received', 'Thirty-one individuals', 'subjects with biallelic RPE65 mutation-associated inherited retinal disease', 'Biallelic RPE65-Mediated Inherited Retinal Disease']","['bilateral subretinal VN injections', 'Delayed intervention (DI) subjects served as controls for 1 year, then received VN']","['bilateral performance on the multi-luminance mobility test (MLMT), a measure of ambulatory navigation, and change from injection baseline in full-field light sensitivity threshold (FST) white light, visual field (VF), and visual acuity (VA', 'Goldmann kinetic VF III4e sum total degrees', 'logMAR', 'ambulatory navigation, light sensitivity, and VF', 'Mean bilateral MLMT change scores', 'Mean change in VA (Holladay scale']","[{'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C2699708', 'cui_str': 'Subretinal route'}, {'cui': 'C4541996', 'cui_str': 'voretigene neparvovec Injection'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4541993', 'cui_str': 'voretigene neparvovec'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0234684', 'cui_str': 'Luminance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439724', 'cui_str': 'Full field'}, {'cui': 'C0085636', 'cui_str': 'Photophobia'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",31.0,0.037388,"Mean bilateral MLMT change scores at Year 4 for OI subjects and at Year 3 for DI subjects were 1.7 and 2.4 respectively, with 71% of subjects with a Year 3 visit able to pass MLMT at the lowest light level.","[{'ForeName': 'Albert M', 'Initials': 'AM', 'LastName': 'Maguire', 'Affiliation': ""Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for Cellular and Molecular Therapeutics, Inc., Children's Hospital of Philadelphia, Philadelphia, Pennsylvania. Electronic address: amaguire@pennmedicine.upenn.edu.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Russell', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa Institute for Vision Research, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Chung', 'Affiliation': 'Spark Therapeutics, Inc., Philadelphia, Pennsylvania.'}, {'ForeName': 'Zi-Fan', 'Initials': 'ZF', 'LastName': 'Yu', 'Affiliation': 'SparingVision, Philadelphia, Pennsylvania.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Tillman', 'Affiliation': 'SparingVision, Philadelphia, Pennsylvania.'}, {'ForeName': 'Arlene V', 'Initials': 'AV', 'LastName': 'Drack', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa Institute for Vision Research, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Simonelli', 'Affiliation': 'Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Bart P', 'Initials': 'BP', 'LastName': 'Leroy', 'Affiliation': ""Division of Ophthalmology and Center for Cellular and Molecular Therapeutics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Ophthalmology and Center for Medical Genetics Ghent, Ghent University Hospital, Ghent, Belgium.""}, {'ForeName': 'Kathleen Z', 'Initials': 'KZ', 'LastName': 'Reape', 'Affiliation': 'Spark Therapeutics, Inc., Philadelphia, Pennsylvania.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'High', 'Affiliation': 'Spark Therapeutics, Inc., Philadelphia, Pennsylvania.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': ""Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for Cellular and Molecular Therapeutics, Inc., Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}]",Ophthalmology,['10.1016/j.ophtha.2021.03.031']
647,33798512,A Cluster Randomized Trial to Reduce Missed Abusive Head Trauma in Pediatric Intensive Care Settings.,"OBJECTIVE


To estimate the impact of the PediBIRN (Pediatric Brain Injury Research Network) 4-variable clinical decision rule (CDR) on abuse evaluations and missed abusive head trauma in pediatric intensive care settings.
STUDY DESIGN


This was a cluster randomized trial. Participants included 8 pediatric intensive care units (PICUs) in US academic medical centers; PICU and child abuse physicians; and consecutive patients with acute head injures <3 years (n = 183 and n = 237, intervention vs control). PICUs were stratified by patient volumes, pair-matched, and randomized equally to intervention or control conditions. Randomization was concealed from the biostatistician. Physician-directed, cluster-level interventions included initial and booster training, access to an abusive head trauma probability calculator, and information sessions. Outcomes included ""higher risk"" patients evaluated thoroughly for abuse (with skeletal survey and retinal examination), potential cases of missed abusive head trauma (patients lacking either evaluation), and estimates of missed abusive head trauma (among potential cases). Group comparisons were performed using generalized linear mixed-effects models.
RESULTS


Intervention physicians evaluated a greater proportion of higher risk patients thoroughly (81% vs 73%, P = .11) and had fewer potential cases of missed abusive head trauma (21% vs 32%, P = .05), although estimated cases of missed abusive head trauma did not differ (7% vs 13%, P = .22). From baseline (in previous studies) to trial, the change in higher risk patients evaluated thoroughly (67%→81% vs 78%→73%, P = .01), and potential cases of missed abusive head trauma (40%→21% vs 29%→32%, P = .003), diverged significantly. We did not identify a significant divergence in the number of estimated cases of missed abusive head trauma (15%→7% vs 11%→13%, P = .22).
CONCLUSIONS


PediBIRN-4 CDR application facilitated changes in abuse evaluations that reduced potential cases of missed abusive head trauma in PICU settings.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03162354.",2021,"RESULTS


Intervention physicians evaluated a greater proportion of higher risk patients thoroughly (81% vs. 73%, P=.11) and had fewer potential cases of missed abusive head trauma (21% vs. 32%, P=.05), although estimated cases of missed abusive head trauma did not differ (7% vs 13%, P=.22).","['Participants were 8 pediatric intensive care units (PICUs) in US academic medical centers; PICU and child abuse physicians; and consecutive acutely head-injured patients <3 years (n=183 and n=237, intervention vs. control']",[],"['potential cases of missed abusive head trauma', 'higher risk"" patients evaluated thoroughly for abuse (with skeletal survey and retinal examination), potential cases of missed abusive head trauma']","[{'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708903', 'cui_str': 'Thoroughly'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0202616', 'cui_str': 'Radiologic examination, osseous survey, complete'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0246946,"RESULTS


Intervention physicians evaluated a greater proportion of higher risk patients thoroughly (81% vs. 73%, P=.11) and had fewer potential cases of missed abusive head trauma (21% vs. 32%, P=.05), although estimated cases of missed abusive head trauma did not differ (7% vs 13%, P=.22).","[{'ForeName': 'Kent P', 'Initials': 'KP', 'LastName': 'Hymel', 'Affiliation': ""Department of Pediatrics, Penn State College of Medicine, Penn State Health Children's Hospital, Hershey, PA.""}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Armijo-Garcia', 'Affiliation': 'University of Texas Health Sciences Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Musick', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Marinello', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Richmond, Richmond, VA.""}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Herman', 'Affiliation': ""Department of Pediatrics, University of Utah School of Medicine, Primary Children's Hospital, Salt Lake City, UT.""}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Weeks', 'Affiliation': 'Department of Pediatrics, University of Kansas School of Medicine, Wichita, KS.'}, {'ForeName': 'Suzanne B', 'Initials': 'SB', 'LastName': 'Haney', 'Affiliation': ""Department of Pediatrics, University of Nebraska Medical Center, Children's Hospital and Medical Center, Omaha, NE.""}, {'ForeName': 'Terra N', 'Initials': 'TN', 'LastName': 'Frazier', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO.""}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Carroll', 'Affiliation': ""Department of Pediatrics, Connecticut Children's Medical Center, Hartford, CT.""}, {'ForeName': 'Natalie N', 'Initials': 'NN', 'LastName': 'Kissoon', 'Affiliation': 'University of Texas Health Sciences Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Isaac', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Foster', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Richmond, Richmond, VA.""}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Campbell', 'Affiliation': ""Department of Pediatrics, University of Utah School of Medicine, Primary Children's Hospital, Salt Lake City, UT.""}, {'ForeName': 'Kelly S', 'Initials': 'KS', 'LastName': 'Tieves', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO.""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Livingston', 'Affiliation': ""Department of Pediatrics, Connecticut Children's Medical Center, Hartford, CT.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Bucher', 'Affiliation': ""Department of Pediatrics, Penn State College of Medicine, Penn State Health Children's Hospital, Hershey, PA.""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Woosley', 'Affiliation': 'University of Texas Health Sciences Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Dorinda', 'Initials': 'D', 'LastName': 'Escamilla-Padilla', 'Affiliation': 'University of Texas Health Sciences Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Jaimon', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Kustka', 'Affiliation': ""Department of Pediatrics, University of Nebraska Medical Center, Children's Hospital and Medical Center, Omaha, NE.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Vernon M', 'Initials': 'VM', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Dias', 'Affiliation': ""Department of Pediatrics, Penn State College of Medicine, Penn State Health Children's Hospital, Hershey, PA; Department of Neurosurgery, Penn State College of Medicine, Hershey, PA.""}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Noll', 'Affiliation': 'Department of Human Development and Family Studies, Penn State University, State College, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2021.03.055']
648,33789010,"Lumasiran, an RNAi Therapeutic for Primary Hyperoxaluria Type 1.","BACKGROUND


Primary hyperoxaluria type 1 (PH1) is a rare genetic disease caused by hepatic overproduction of oxalate that leads to kidney stones, nephrocalcinosis, kidney failure, and systemic oxalosis. Lumasiran, an investigational RNA interference (RNAi) therapeutic agent, reduces hepatic oxalate production by targeting glycolate oxidase.
METHODS


In this double-blind, phase 3 trial, we randomly assigned (in a 2:1 ratio) patients with PH1 who were 6 years of age or older to receive subcutaneous lumasiran or placebo for 6 months (with doses given at baseline and at months 1, 2, 3, and 6). The primary end point was the percent change in 24-hour urinary oxalate excretion from baseline to month 6 (mean percent change across months 3 through 6). Secondary end points included the percent change in the plasma oxalate level from baseline to month 6 (mean percent change across months 3 through 6) and the percentage of patients with 24-hour urinary oxalate excretion no higher than 1.5 times the upper limit of the normal range at month 6.
RESULTS


A total of 39 patients underwent randomization; 26 were assigned to the lumasiran group and 13 to the placebo group. The least-squares mean difference in the change in 24-hour urinary oxalate excretion (lumasiran minus placebo) was -53.5 percentage points (P<0.001), with a reduction in the lumasiran group of 65.4% and an effect seen as early as month 1. The between-group differences for all hierarchically tested secondary end points were significant. The difference in the percent change in the plasma oxalate level (lumasiran minus placebo) was -39.5 percentage points (P<0.001). In the lumasiran group, 84% of patients had 24-hour urinary oxalate excretion no higher than 1.5 times the upper limit of the normal range at month 6, as compared with 0% in the placebo group (P<0.001). Mild, transient injection-site reactions were reported in 38% of lumasiran-treated patients.
CONCLUSIONS


Lumasiran reduced urinary oxalate excretion, the cause of progressive kidney failure in PH1. The majority of patients who received lumasiran had normal or near-normal levels after 6 months of treatment. (Funded by Alnylam Pharmaceuticals; ILLUMINATE-A ClinicalTrials.gov number, NCT03681184.).",2021,"Lumasiran, an investigational RNA interference (RNAi) therapeutic agent, reduces hepatic oxalate production by targeting glycolate oxidase.
","['for 6 months (with doses given at baseline and at months 1, 2, 3, and 6', '39 patients underwent randomization; 26 were assigned to the lumasiran group and 13 to the', '2:1 ratio) patients with PH1 who were 6 years of age or older to receive']","['placebo', 'subcutaneous lumasiran or placebo']","['hepatic oxalate production', 'plasma oxalate level', 'normal or near-normal levels', '24-hour urinary oxalate excretion', 'Mild, transient injection-site reactions', '24-hour urinary oxalate excretion (lumasiran minus placebo', 'urinary oxalate excretion']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0268164', 'cui_str': 'Primary hyperoxaluria, type I'}, {'cui': 'C0444858', 'cui_str': 'AM 6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C1318658', 'cui_str': 'Plasma oxalate level'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",39.0,0.582818,"Lumasiran, an investigational RNA interference (RNAi) therapeutic agent, reduces hepatic oxalate production by targeting glycolate oxidase.
","[{'ForeName': 'Sander F', 'Initials': 'SF', 'LastName': 'Garrelfs', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Yaacov', 'Initials': 'Y', 'LastName': 'Frishberg', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Hulton', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Koren', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': ""O'Riordan"", 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Cochat', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Deschênes', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Shasha-Lavsky', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Saland', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': ""Van't Hoff"", 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Fuster', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Magen', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Shabbir H', 'Initials': 'SH', 'LastName': 'Moochhala', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Schalk', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Simkova', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Jaap W', 'Initials': 'JW', 'LastName': 'Groothoff', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Sas', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Meliambro', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Pushkal P', 'Initials': 'PP', 'LastName': 'Garg', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Akshay K', 'Initials': 'AK', 'LastName': 'Vaishnaw', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Gansner', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Lieske', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2021712']
649,33814546,Association of Aripiprazole With Reduced Hippocampal Atrophy During Maintenance Treatment of First-Episode Schizophrenia.,"PURPOSE/BACKGROUND


Hippocampal volume loss in early schizophrenia has been linked with markers of inflammation and oxidative stress, and with less response of negative symptoms. Aripiprazole has been reported to preserve hippocampal volume and to reduce inflammation.
METHODS/PROCEDURES


Study 1 was a 12-month multicenter randomized placebo-controlled trial of citalopram added to clinician-determined second-generation antipsychotic medication in 95 patients with first-episode schizophrenia (FES), 19 of whom received aripiprazole. We compared participants taking aripiprazole with those on other antipsychotics to determine whether those on aripiprazole had less hippocampal volume loss. We also examined peripheral biomarker data from medication-naive patients with schizophrenia receiving 8 weeks of antipsychotic treatment (n = 24) to see whether markers of inflammation and oxidative stress that previously predicted hippocampal volume differed between aripiprazole (n = 9) and other antipsychotics (study 2).
FINDINGS/RESULTS


Aripiprazole was associated with a mean increase in hippocampal volume of 0.35% (SD, 0.80%) compared with a 0.53% decrease (SD, 1.2%) with other antipsychotics during the first year of maintenance treatment in patients with FES. This difference was significant after adjusting for age, sex, citalopram treatment, and baseline Brief Psychiatric Rating Scale score (B = 0.0079, P = 0.03). Aripiprazole was also associated with reduced concentrations of the inflammatory cytokines interleukin-8 and tumor necrosis factor (P < 0.01) during the first 8 weeks of treatment in medication-naive patients with FES.
IMPLICATIONS/CONCLUSIONS


These results suggest that aripiprazole may protect against hippocampal atrophy via an anti-inflammatory mechanism, but these results require replication in larger, randomized trials, and the clinical relevance of hippocampal volume loss is not established.",2021,"This difference was significant after adjusting for age, sex, citalopram treatment, and baseline Brief Psychiatric Rating Scale score (B = 0.0079, P = 0.03).","['medication-naive patients with schizophrenia receiving 8 weeks of antipsychotic treatment (n = 24', 'n = 9) and other antipsychotics (study 2', 'patients with FES', '95 patients with first-episode schizophrenia (FES), 19 of whom received']","['aripiprazole', 'Aripiprazole', 'placebo', 'citalopram added to clinician-determined second-generation antipsychotic medication']","['reduced concentrations of the inflammatory cytokines interleukin-8 and tumor necrosis factor', 'hippocampal volume loss', 'hippocampal volume', 'Hippocampal Atrophy', 'baseline Brief Psychiatric Rating Scale score']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3653897', 'cui_str': 'Other antipsychotics'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439615', 'cui_str': 'First episode'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0424099', 'cui_str': 'Reduced concentration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4315130', 'cui_str': 'Hippocampal atrophy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",95.0,0.0661754,"This difference was significant after adjusting for age, sex, citalopram treatment, and baseline Brief Psychiatric Rating Scale score (B = 0.0079, P = 0.03).","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Psychiatry, NYU Langone Health, New York.'}, {'ForeName': 'Kamber L', 'Initials': 'KL', 'LastName': 'Hart', 'Affiliation': 'From the Department of Psychiatry, NYU Langone Health, New York.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qi', 'Affiliation': 'From the Department of Psychiatry, NYU Langone Health, New York.'}, {'ForeName': 'Babak A', 'Initials': 'BA', 'LastName': 'Ardekani', 'Affiliation': ''}, {'ForeName': 'Chenxiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Division of Biostatistics, Department of Population Health, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Marx', 'Affiliation': 'From the Department of Psychiatry, NYU Langone Health, New York.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Freudenreich', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Holt', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Iruma', 'Initials': 'I', 'LastName': 'Bello', 'Affiliation': ''}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Diminich', 'Affiliation': 'Program in Public Health, Department of Family, Population, and Preventive Medicine, Stony Brook School of Medicine, Health Sciences Center, Stony Brook, NY.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Worthington', 'Affiliation': 'From the Department of Psychiatry, NYU Langone Health, New York.'}, {'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Zeng', 'Affiliation': 'Department of Psychiatry, Qingdao Mental Health Center, Qingdao.'}, {'ForeName': 'Renrong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center for Mental Disorders, Mental Health Institute, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiaoduo', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Jingping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'National Clinical Research Center for Mental Disorders, Mental Health Institute, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001391']
650,33780567,Pathway with single-dose long-acting intravenous antibiotic reduces emergency department hospitalizations of patients with skin infections.,"OBJECTIVES


Emergency department (ED) patients with serious skin and soft tissue infections (SSTIs) are often hospitalized to receive intravenous (IV) antibiotics. Appropriate patients may avoid admission following a single-dose, long-acting IV antibiotic.
METHODS


We conducted a preintervention versus postintervention design trial at 11 U.S. EDs comparing hospitalization rates under usual care to those using a clinical pathway that included a single IV dalbavancin dose. We enrolled adults with cellulitis, abscess, or wound infection with an infected area of ≥75 cm 2  without other indications for hospitalization. Clinical pathway participants discharged from the ED received a 24-hour follow-up telephone call and had a 48- to 72-hour in-person visit. We hypothesized that, compared to usual care, the clinical pathway would result in a significant reduction in the initial hospitalization rate.
RESULTS


Of 156 and 153 participants in usual care and clinical pathway periods, median infection areas were 255.0 (interquartile range [IQR] = 150.0 to 500.0) cm 2  and 289.0 (IQR = 161.3 to 555.0) cm 2  , respectively. During their initial care, 60 (38.5%) usual care participants were hospitalized and 27 (17.6%) pathway participants were hospitalized (difference = 20.8 percentage points [PP], 95% confidence interval [CI] = 10.4 to 31.2 PP). Over 44 days, 70 (44.9%) usual care and 44 (28.8%) pathway participants were hospitalized (difference = 16.1 PP, 95% CI = 4.9 to 27.4 PP).
CONCLUSIONS


Implementation of an ED SSTI clinical pathway for patient selection and follow-up that included use of a single-dose, long-acting IV antibiotic was associated with a significant reduction in hospitalization rate for stable patients with moderately severe infections. Registration: NCT02961764.",2021,"pathway participants were hospitalized (difference, 16.1 PP; 95% CI, 4.9 to 27.4 PP).
","['enrolled adults with cellulitis, abscess, or wound infection with an infected area of ≥75 cm 2  without other indications for hospitalization', 'Emergency department (ED) patients with serious skin and soft tissue infections (SSTI', 'Of 156 and 153 participants in usual care and clinical pathway periods', 'Patients With Skin Infections']",['intravenous (IV) antibiotics'],"['hospitalization rates', 'hospitalization rate', 'median infection area']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C0282654', 'cui_str': 'Clinical Pathways'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.242638,"pathway participants were hospitalized (difference, 16.1 PP; 95% CI, 4.9 to 27.4 PP).
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Talan', 'Affiliation': 'Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at the University of California at Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Mower', 'Affiliation': 'Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at the University of California at Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Lovecchio', 'Affiliation': 'Valleywise Health, ASU, University of Arizona and Creighton College of Medicine, Phoenix, Arizona, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Rothman', 'Affiliation': 'Johns Hopkins Medical Center, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Steele', 'Affiliation': 'Truman Medical Center, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, USA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Keyloun', 'Affiliation': 'AbbVie Inc, Irvine, California, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Gillard', 'Affiliation': 'AbbVie Inc, Irvine, California, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Copp', 'Affiliation': 'ICON plc, Dublin, Ireland.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Moran', 'Affiliation': 'Olive View, UCLA Medical Center, David Geffen School of Medicine at the University of California at Los Angeles, Los Angeles, California, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14258']
651,33817934,"Systematised, Interdisciplinary Malnutrition Program for impLementation and Evaluation delivers improved hospital nutrition care processes and patient reported experiences - An implementation study.","AIM


Models of hospital malnutrition care reliant on dietitians can be inefficient and of limited effectiveness. This study evaluated whether implementing the Systematised, Interdisciplinary Malnutrition Program for impLementation and Evaluation (SIMPLE) improved hospital nutrition care processes and patientreported experiences compared with traditional practice.
METHODS


A multi-site (five hospitals) prospective, pre-post study evaluated the facilitated implementation of SIMPLE, a malnutrition care pathway promoting proactive nutrition support delivered from time of malnutrition screening by the interdisciplinary team, without need for prior dietetic assessment. Implementation was tailored to local site needs and resources. Nutrition care processes delivered to inpatients who were malnourished or at-risk of malnutrition were identified across diagnosis, intervention, and monitoring domains using standardised audits from medical records, foodservice systems and patient-reported nutrition experience measures.
RESULTS


Pre-implementation (n = 365) and post-implementation (n = 397) cohorts were similar for age (74 vs 73 years), gender (47.1% vs 48.6% female), and nutrition risk status (46.6% vs 45.3% at-risk). Post-implementation, at-risk participants were more likely to receive enhanced food and fluids (68.5% vs 83.9%; P < .01), nutrition information (30.9% vs 47.2%; P < .01), mealtime assistance where required (61.4% vs 77.9% P = .04), nutrition monitoring (25.2% vs 46.3%; P < .01) and care planning (17.8% vs 27.7%; P = .01). Patient-reported nutrition experience measures confirmed improved nutrition care. There was no difference in dietetic occasions of service per patient (1.51 vs 1.25; P = .83).
CONCLUSIONS


Tailored SIMPLE implementation improves nutrition care processes and patient reported nutrition experience measures for at-risk inpatients within existing dietetic resources.",2021,"There was no difference in dietetic occasions of service per patient (1.51 vs 1.25; P = .83).
","['inpatients who were malnourished or at-risk of malnutrition were identified across diagnosis, intervention, and monitoring domains using standardised audits from medical records, foodservice systems and patient-reported nutrition experience measures']","['malnutrition care pathway promoting proactive nutrition support delivered from time of malnutrition screening by the interdisciplinary team, without need for prior dietetic assessment']","['care planning', 'nutrition care processes', 'nutrition care', 'nutrition monitoring', 'mealtime assistance', 'dietetic occasions', 'nutrition risk status', 'nutrition information']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0740214', 'cui_str': 'Malnutrition screening'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C1258068', 'cui_str': 'Nutrition management'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0204699', 'cui_str': 'Mealtime assistance'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.024454,"There was no difference in dietetic occasions of service per patient (1.51 vs 1.25; P = .83).
","[{'ForeName': 'Jack J', 'Initials': 'JJ', 'LastName': 'Bell', 'Affiliation': 'Allied Health, The Prince Charles Hospital, Metro North HHS, Brisbane, Queensland, Australia.'}, {'ForeName': 'Adrienne M', 'Initials': 'AM', 'LastName': 'Young', 'Affiliation': ""Nutrition and Dietetics, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Hill', 'Affiliation': 'Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Merrilyn D', 'Initials': 'MD', 'LastName': 'Banks', 'Affiliation': ""Nutrition and Dietetics, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Comans', 'Affiliation': 'Centre for Health Services Research, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Barnes', 'Affiliation': ""Nutrition and Dietetics, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Heather H', 'Initials': 'HH', 'LastName': 'Keller', 'Affiliation': 'Schlegel-UW Research Institute for Aging, Waterloo, Ontario, Canada.'}]",Nutrition & dietetics: the journal of the Dietitians Association of Australia,['10.1111/1747-0080.12663']
652,33781142,The impact of fluticasone furoate/vilanterol on healthcare resource utilisation in the Salford Lung Study in chronic obstructive pulmonary disease.,"AIM


The Salford Lung Study (SLS) in chronic obstructive pulmonary disease (COPD) was a randomised controlled trial evaluating the effectiveness and safety of initiating fluticasone furoate/vilanterol (FF/VI) 100/25 µg  versus  continuing usual care (UC) in patients with COPD and a history of exacerbations. Here, we investigate the impact of initiating FF/VI on healthcare resource utilisation (HRU) in SLS COPD.
METHODS


HRU and interventions were determined from patients' electronic health records. Annual rates of on-treatment all-cause and COPD-related secondary care contacts (SCCs) and primary care contacts (PCCs) for FF/VI  versus  UC were analysed using a general linear model. Costs were derived from national data sources.
RESULTS


Least-squares (LS) mean annual rates of all-cause (9.81  versus  9.36) and COPD-related (1.57  versus  1.48) SCCs were similar for FF/VI and UC, as were rates of all-cause hospitalisations (0.87  versus  0.82). Mean duration of hospital stay/patient was 4.5 and 4.2 days, respectively. COPD-related SCC mean total cost/patient was £484 FF/VI and £475 UC. LS mean annual rates of all-cause PCCs were significantly higher for FF/VI (21.20  versus  18.88 UC;  p  < 0.001). LS mean annual rates of COPD-related PCCs were similar for FF/VI and UC (2.42  versus  2.46). All-cause PCC mean total cost/patient was £900 FF/VI  versus  £811 UC, but COPD-related PCC costs were similar (£116  versus  £114). Direct COPD-related total medical costs/patient were significantly lower for FF/VI (LS geometric mean £806  versus  £963 UC;  p  < 0.001).
DISCUSSION


In patients with COPD and exacerbation history, FF/VI may represent a less costly alternative to current therapies.GlaxoSmithKline plc. study HZC115151; ClinicalTrials.gov NCT01551758. The reviews of this paper are available via the supplemental material section.",2021,Direct COPD-related total medical costs/patient were significantly lower for FF/VI (LS geometric mean £806  versus  £963 UC;  ,"['chronic obstructive pulmonary disease', 'chronic obstructive pulmonary disease (COPD', 'patients with COPD and a history of exacerbations']","['fluticasone furoate/vilanterol (FF/VI', '100/25\u2009µg  versus  continuing usual care (UC', 'GlaxoSmithKline plc', 'fluticasone furoate/vilanterol', 'Salford Lung Study (SLS']","['SCCs', 'LS mean annual rates of all-cause PCCs', 'healthcare resource utilisation', 'Mean duration of hospital stay/patient', 'LS mean annual rates of COPD-related PCCs', 'Direct COPD-related total medical costs/patient', 'COPD-related PCC costs']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}]",,0.438938,Direct COPD-related total medical costs/patient were significantly lower for FF/VI (LS geometric mean £806  versus  £963 UC;  ,"[{'ForeName': 'Nawar Diar', 'Initials': 'ND', 'LastName': 'Bakerly', 'Affiliation': 'Department of Respiratory Medicine, Salford Royal NHS Foundation Trust, Stott Lane, Salford M6 8HD, UK.'}, {'ForeName': 'Dominy', 'Initials': 'D', 'LastName': 'Browning', 'Affiliation': 'Respiratory Research and Development, GlaxoSmithKline plc., Brentford, Middlesex, UK.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boucot', 'Affiliation': 'Global Respiratory Therapy Area, GlaxoSmithKline plc., Brentford, Middlesex, UK.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Crawford', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline plc., Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'McCorkindale', 'Affiliation': 'NIHR Clinical Research Network Greater Manchester, Citylabs 1.0, Manchester, UK.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Stein', 'Affiliation': 'Manchester Academic Health Sciences Centre, University of Manchester, Citylabs 1.0, Manchester.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'New', 'Affiliation': 'Department of Respiratory Medicine, Salford Royal NHS Foundation Trust, Salford, UK.'}]",Therapeutic advances in respiratory disease,['10.1177/17534666211001013']
653,33781141,The value of imaging and clinical outcomes in a phase II clinical trial of a lysophosphatidic acid receptor antagonist in idiopathic pulmonary fibrosis.,"BACKGROUND


Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive fibrotic lung disease characterized by worsening dyspnea and lung function and has a median survival of 2-3 years. Forced vital capacity (FVC) is the primary endpoint used most commonly in IPF clinical trials as it is the best surrogate for mortality. This study assessed quantitative scores from high-resolution computed tomography (HRCT) developed by machine learning as a secondary efficacy endpoint in a 26-week phase II study of BMS-986020 - an LPA 1  receptor antagonist - in patients with IPF.
METHODS


HRCT scans from 96% (137/142) of randomized subjects were utilized. Quantitative lung fibrosis (QLF) scores were calculated from the HRCT images. QLF improvement was defined as ⩾2% reduction in QLF score from baseline to week 26.
RESULTS


In the placebo arm, 5% of patients demonstrated an improvement in QLF score at week 26 compared with 15% and 27% of patients in the BMS-986020 600 mg once daily (QD) and twice daily (BID) arms, respectively [ versus  placebo:  p  = 0.08 (600 mg QD);  p  = 0.0098 (600 mg BID)]. Significant correlations were found between changes in QLF and changes in percent predicted FVC, diffusing capacity for carbon monoxide (DLCO), and shortness of breath at week 26 ( ρ  = -0.41,  ρ  = -0.22, and  ρ  = 0.27, respectively; all  p  < 0.01).
CONCLUSIONS


This study demonstrated the utility of quantitative HRCT as an efficacy endpoint for IPF in a double-blind, placebo-controlled clinical trial setting. The reviews of this paper are available via the supplemental material section.",2021,"Significant correlations were found between changes in QLF and changes in percent predicted FVC, diffusing capacity for carbon monoxide (DLCO), and shortness of breath at week 26 ( ρ  = -0.41,  ρ  = -0.22, and  ρ  = 0.27, respectively; all  p  < 0.01).
","['patients with IPF', 'Idiopathic pulmonary fibrosis (IPF', 'idiopathic pulmonary fibrosis', 'HRCT scans from 96% (137/142) of randomized subjects were utilized']","['quantitative HRCT', 'BMS-986020', 'lysophosphatidic acid receptor antagonist', 'high-resolution computed tomography (HRCT', 'placebo']","['Quantitative lung fibrosis (QLF) scores', 'Forced vital capacity (FVC', 'QLF improvement', 'QLF score', 'FVC, diffusing capacity for carbon monoxide (DLCO), and shortness of breath']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0170267', 'cui_str': 'Receptor, Lysophosphatidic Acid'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",,0.318855,"Significant correlations were found between changes in QLF and changes in percent predicted FVC, diffusing capacity for carbon monoxide (DLCO), and shortness of breath at week 26 ( ρ  = -0.41,  ρ  = -0.22, and  ρ  = 0.27, respectively; all  p  < 0.01).
","[{'ForeName': 'Grace Hyun J', 'Initials': 'GHJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiological Sciences, David-Geffen School of Medicine, and Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Goldin', 'Affiliation': 'Department of Radiological Sciences, David-Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hayes', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Oh', 'Affiliation': 'Department of Radiology, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Soule', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Shuyan', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/17534666211004238']
654,33781130,Comparison of outcomes of high-flow nasal cannula and noninvasive positive-pressure ventilation in patients with hypoxemia and various APACHE II scores after extubation.,"AIMS


The study aimed to compare and analyze the outcomes of high-flow nasal cannula (HFNC) and noninvasive positive-pressure ventilation (NPPV) in the treatment of patients with acute hypoxemic respiratory failure (AHRF) who had extubation after weaning from mechanical ventilation.
METHODS


A total 120 patients with AHRF were enrolled into this study. These patients underwent tracheal intubation and mechanical ventilation. They were organized into two groups according to the score of Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II); group A: APACHE II score <12; group B: 12⩽ APACHE II score <24. Group A had 72 patients and patients given HFNC were randomly assigned to subgroup I while patients given NPPV were assigned to subgroup II (36 patients in each subgroup). Group B had 48 patients and patients given HFNC were randomly assigned to subgroup I while patients given NPPV were assigned to subgroup II (24 patients in each subgroup). General information, respiratory parameters, endpoint event, and comorbidities of adverse effect were compared and analyzed between the two subgroups.
RESULTS


The incidence of abdominal distension was significantly higher in patients treated with NPPV than in those treated with HFNC in group A (19.44%  versus  0,  p  = 0.005) and group B (25%  versus  0,  p  = 0.009). There was no significant difference between the HFNC- and NPPV-treated patients in blood pH, oxygenation index, partial pressure of carbon dioxide, respiratory rate, and blood lactic acid concentration in either group ( p  > 0.05). Occurrence rate of re-intubation within 72 h of extubation was slightly, but not significantly, higher in NPPV-treated patients ( p  > 0.05).
CONCLUSION


There was no significant difference between HFNC and NPPV in preventing respiratory failure in patients with AHRF with an APACHE II score <24 after extubation. However, HFNC was superior to NPPV with less incidence of abdominal distension. The reviews of this paper are available via the supplemental material section.",2021,There was no significant difference between HFNC and NPPV in preventing respiratory failure in patients with AHRF with an APACHE II score <24 after extubation.,"['patients with acute hypoxemic respiratory failure (AHRF) who had extubation after weaning from mechanical ventilation', 'A total 120 patients with AHRF', 'patients with AHRF with an APACHE II score <24 after extubation', '48 patients and patients given HFNC', 'patients with hypoxemia and various APACHE II scores after extubation', '72 patients and patients given HFNC']","['NPPV', 'HFNC and NPPV', 'high-flow nasal cannula (HFNC) and noninvasive positive-pressure ventilation (NPPV', 'HFNC', 'tracheal intubation and mechanical ventilation', 'high-flow nasal cannula and noninvasive positive-pressure ventilation']","['incidence of abdominal distension', 'respiratory failure', 'General information, respiratory parameters, endpoint event, and comorbidities of adverse effect', 'abdominal distension', 'blood pH, oxygenation index, partial pressure of carbon dioxide, respiratory rate, and blood lactic acid concentration', 'Occurrence rate of re-intubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]","[{'cui': 'C3164735', 'cui_str': 'Noninvasive positive pressure ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0853170', 'cui_str': 'Blood lactic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",120.0,0.026663,There was no significant difference between HFNC and NPPV in preventing respiratory failure in patients with AHRF with an APACHE II score <24 after extubation.,"[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Shang', 'Affiliation': 'Department of Internal Medicine, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, China.'}, {'ForeName': 'Yanggan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Zhongnan Hospital of Wuhan University, Wuhan University, No.169 East Lake Road, Wuchang District, Wuhan, Hubei, 430071, China.'}]",Therapeutic advances in respiratory disease,['10.1177/17534666211004235']
655,33780423,Short-term Tolerance of Nasally-administered NeuroEPO in Patients with Parkinson Disease.,"INTRODUCTION


No neuroprotective treatment has been able to successfully halt the progression of Parkinson disease or prevent development of associated complications. Recombinant erythropoetin (EPO), an erythropoiesis-stimulating agent originally indicated in anemia, produced and manufactured in Cuba (iorEPOCIM, CIMAB S.A, Havana, Cuba) has neuroprotective properties. NeuroEPO is a new nasal formulation of recombinant EPO with a low content of sialic acid and without hematopoietic effects. It has neuroprotective effects in animal models.
OBJECTIVE


Evaluate short-term tolerance of intranasal NeuroEPO in patients with Parkinson disease.
METHODS


As part of a monocentric randomized placebo-controlled double-blind study (registered at www.clinicaltrials.gov number NCT04110678), 26 patients with Parkinson disease (stages 1 and 2 on Hoehn & Yahr Scale), were randomly divided into two groups: NeuroEPO (n = 15) and placebo (n = 11), both treated intranasally either with the drug (1 mL, at a concentration of 1 mg/mL of NeuroEPO) or placebo once a week for 5 weeks. At each application, we recorded any adverse events and blood pressure. To assess potential hematopoietic effects of the drug, hematological and biochemical variables were evaluated one week before and one week after the intervention.
RESULTS


There were no significant differences (p = 0.22) between the two groups in terms of frequency of adverse events (20.0% in NeuroEPO and 9.1% in placebo groups). Three patients in NeuroEPO presented nausea, and one vomited (possibly due to the patient's positioning during drug application). One patient in placebo group reported polyuria and nasal irritation. In both groups, the adverse events were mild, brief, required no treatment and did not present sequelae.
CONCLUSIONS


Nasally administered NeuroEPO for five weeks in patients with Parkinson disease stages 1 and 2 on Hoehn & Yahr Scale is well tolerated.",2021,There were no significant differences (p = 0.22) between the two groups in terms of frequency of adverse events (20.0% in NeuroEPO and 9.1% in placebo groups).,"['patients with Parkinson disease', 'Patients with Parkinson Disease', '26 patients with Parkinson disease (stages 1 and 2 on Hoehn & Yahr Scale']","['NeuroEPO', 'Recombinant erythropoetin (EPO', 'intranasal NeuroEPO', 'placebo', 'Nasally-administered NeuroEPO', 'recombinant EPO']","['adverse events and blood pressure', 'tolerated', 'nausea', 'polyuria and nasal irritation', 'adverse events', 'frequency of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0032617', 'cui_str': 'Polyuria'}, {'cui': 'C0240557', 'cui_str': 'Irritation of nose'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",26.0,0.22719,There were no significant differences (p = 0.22) between the two groups in terms of frequency of adverse events (20.0% in NeuroEPO and 9.1% in placebo groups).,"[{'ForeName': 'Marité', 'Initials': 'M', 'LastName': 'García-Llano', 'Affiliation': 'Abel Santamaría Cuadrado Provincial Clinical-Surgical Hospital, Pinar del Río, Cuba.'}, {'ForeName': 'Ivonne', 'Initials': 'I', 'LastName': 'Pedroso-Ibáñez', 'Affiliation': 'Movement Disorders Clinic, International Neurological Restoration Center (CIREN), Havana, Cuba.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Morales-Chacón', 'Affiliation': 'Medical University of Havana, Cuba.'}, {'ForeName': 'Teresita', 'Initials': 'T', 'LastName': 'Rodríguez-Obaya', 'Affiliation': 'Molecular Immunology Center (CIM), Cuba.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Pérez-Ruiz', 'Affiliation': 'Molecular Immunology Center (CIM), Cuba.'}, {'ForeName': 'Iliana', 'Initials': 'I', 'LastName': 'Sosa-Testé', 'Affiliation': 'National Laboratory Animal Production Center (CENPALAB), Havana, Cuba.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Amaro-González', 'Affiliation': 'Molecular Immunology Center (CIM), Cuba.'}, {'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'Bringas-Vega', 'Affiliation': 'Cuba-China Joint Lab for Neurotechnology.'}]",MEDICC review,['10.37757/MR2021.V23.N1.10']
656,33783399,Combined Oxytocin and Cognitive Behavioral Social Skills Training for Social Function in People With Schizophrenia.,"BACKGROUND


A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others. The development of effective interventions for social functioning remains a central therapeutic challenge. Cognitive-behavioral social skills training (CBSST) has been found to improve social functioning in schizophrenia, but with only medium effect sizes. Intranasal oxytocin also has prosocial effects, but also only with modest effect sizes. This study assessed whether the addition of intranasal oxytocin to CBSST can strengthen their impact on social function.
METHODS


Participants (N = 62) with schizophrenia or schizoaffective disorder entered a 24-week, double-blind, placebo-controlled, randomized clinical trial with a 3-month follow-up evaluation at 2 sites: Maryland and San Diego. Participants were randomized to either intranasal oxytocin 36 IU (3 sprays) twice a day (n = 31) or intranasal placebo-oxytocin (3 sprays) twice a day (n = 31). All participants received CBSST plus a social cognition skills training module (48 total sessions).
RESULTS


There were no significant treatment group differences in social functioning, positive symptoms, negative symptoms, defeatist beliefs, or asocial beliefs. The interpretation of treatment effects was complicated by site effects, whereby participants in San Diego began the trial with greater severity of impairments and subsequently showed greater improvements compared with participants in Maryland.
CONCLUSIONS


The results did not support the utility of add-on intranasal oxytocin to psychosocial rehabilitation interventions like CBSST for improvement in social function (ClinicalTrials.gov trial number: NCT01752712).",2021,The results did not support the utility of add-on intranasal oxytocin to psychosocial rehabilitation interventions like CBSST for improvement in social function (ClinicalTrials.gov trial number: NCT01752712).,"['Participants (N = 62) with schizophrenia or schizoaffective disorder', 'People With Schizophrenia']","['Cognitive-behavioral social skills training (CBSST', 'Combined Oxytocin and Cognitive Behavioral Social Skills Training', 'intranasal placebo-oxytocin', 'intranasal oxytocin', 'Intranasal oxytocin', 'placebo', 'CBSST plus a social cognition skills training module', 'Maryland and San Diego']","['social functioning, positive symptoms, negative symptoms, defeatist beliefs, or asocial beliefs']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150777', 'cui_str': 'Social skills training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",62.0,0.104902,The results did not support the utility of add-on intranasal oxytocin to psychosocial rehabilitation interventions like CBSST for improvement in social function (ClinicalTrials.gov trial number: NCT01752712).,"[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Buchanan', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Deanna L', 'Initials': 'DL', 'LastName': 'Kelly', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Strauss', 'Affiliation': 'Department of Psychology, University of Georgia, Athens, GA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Gold', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Weiner', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Zaranski', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Blatt', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Holden', 'Affiliation': 'Veterans Affairs San Diego Healthcare System; Department of Psychiatry, University of California, San Diego School of Medicine, San Diego, CA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Granholm', 'Affiliation': 'Veterans Affairs San Diego Healthcare System; Department of Psychiatry, University of California, San Diego School of Medicine, San Diego, CA.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001397']
657,33563102,Effects of Hand Hygiene Using 4% Chlorhexidine Gluconate or Natural Soap During Hand Rubbing Followed by Alcohol-Based 1% Chlorhexidine Gluconate Sanitizer Lotion in the Operating Room.,"Objective:  Hand hygiene using either 4% chlorhexidine gluconate (CHG) or natural soap during hand rubbing, followed by alcohol-based 1% CHG sanitizer lotion in the operating room was compared to assess bacterial reduction, skin moisture, skin texture, and hand hygiene using qualitative questionnaires.  Approach:  A crossover study with 36 professional scrub nurses at two medical centers was performed to compare 4% CHG followed by alcohol-based 1% CHG sanitizer lotion, the Two-stage method with handwashing using natural soap followed by alcohol-based 1% CHG sanitizer lotion, and the Waterless method, after a period of 10 days of use. The study completely followed CONSORT, www.consort-statement.org.  Results:  There was no significant difference in bacterial reduction based on the bacterial colony-forming units between the two methods. The skin moisture and skin roughness scores were not significantly different between the two methods. The Waterless method was significantly better than the Two-stage method regarding ""foaming,"" ""quality,"" ""longevity"" ( p  < 0.0001,  p  < 0.0001, and  p  < 0.0001, respectively), but ""disappearance"" was significantly better by the Two-stage method ( p  = 0.0095) during washing and rubbing. Immediately after washing and rubbing, the Waterless method was significantly better regarding ""tightness"" and ""moisture,"" whereas the Two-stage method was significantly better regarding ""stickiness"" ( p  = 0.0114,  p  = <0.0001, and 0.0059, respectively)  Innovation:  The Waterless method using natural soap during handwashing followed by alcohol-based 1% CHG sanitizer lotion was as effective as the Two-stage method of 4% CHG followed by alcohol-based 1% CHG sanitizer lotion.  Conclusion:  Handwashing using natural soap is simple and superior to hand scrubbing in several aspects.",2022,"Immediately after washing and rubbing, the Waterless method was significantly better regarding ""tightness"" and ""moisture,"" whereas the Two-stage method was significantly better regarding ""stickiness"" ( p  = 0.0114,  p  = <0.0001, and 0.0059, respectively)  ",['36 professional scrub nurses at two medical centers'],"['natural soap during handwashing followed by alcohol-based 1% CHG sanitizer lotion', 'CHG followed by alcohol-based 1% CHG sanitizer lotion, the Two-stage method with handwashing using natural soap followed by alcohol-based 1% CHG sanitizer lotion', 'chlorhexidine gluconate (CHG) or natural soap during hand rubbing, followed by alcohol-based 1% CHG sanitizer lotion', 'Hand Hygiene Using 4% Chlorhexidine Gluconate or Natural Soap During Hand Rubbing Followed by Alcohol-Based 1% Chlorhexidine Gluconate Sanitizer Lotion']","['disappearance', 'skin moisture and skin roughness scores', 'bacterial reduction, skin moisture, skin texture, and hand hygiene using qualitative questionnaires', 'tightness"" and ""moisture', 'foaming,"" ""quality,"" ""longevity', 'bacterial reduction']","[{'cui': 'C1531952', 'cui_str': 'Scrub nurse'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008586', 'cui_str': 'Chromogranin'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}]",36.0,0.00571283,"Immediately after washing and rubbing, the Waterless method was significantly better regarding ""tightness"" and ""moisture,"" whereas the Two-stage method was significantly better regarding ""stickiness"" ( p  = 0.0114,  p  = <0.0001, and 0.0059, respectively)  ","[{'ForeName': 'Sadanori', 'Initials': 'S', 'LastName': 'Akita', 'Affiliation': 'Department of Plastic Surgery, Wound Repair and Regeneration, School of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Fujioka', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, National Hospital Organization, Nagasaki Medical Center, Nagasaki, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Akita', 'Affiliation': 'Department of Epidemiology, Infectious Disease Control and Prevention, Graduate School of Biomedical & Health Science, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Tanaka', 'Affiliation': 'Department of Epidemiology, Infectious Disease Control and Prevention, Graduate School of Biomedical & Health Science, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Masunaga', 'Affiliation': 'Shabondama Soap Co., Ltd., Fukuoka, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Shabondama Soap Co., Ltd., Fukuoka, Japan.'}]",Advances in wound care,['10.1089/wound.2020.1352']
658,33780271,The Utility of Solution-Oriented Strategies to Support Grandparents Raising Grandchildren.,"Objectives:  The purpose of this article is to evaluate the effectiveness of a psychosocial intervention program to improve the health and social psychological outcomes for grandparents raising grandchildren using the theory of Selection, Optimization, and Compensation (Baltes, P. B., & Baltes, M. M. (1990). Psychological perspectives on successful aging: The model of selective optimization with compensation. In P. B. Baltes & M. M. Baltes (Eds.), Successful aging: Perspectives from the behavioral sciences (pp. 1-34). Cambridge University Press. doi:10.1017/CBO9780511665684.003).  Methods : Fifty-two grandparents were randomly assigned either to a 6-session solution-oriented goal-setting program or to a waiting list control condition who subsequently received the intervention.  Results:  Grandparents in the intervention group, in comparison to the waiting list control group, reduced their level of depression, improved their parental efficacy, overall psychosocial adjustment, and increased their ability to choose effective goals. For the most part, findings were replicated in the waiting list control analyses.  Discussion:  While these findings are consistent with previous studies using psychosocial interventions with parents and grandparent caregivers, they also provide support for strength-based proactive behavioral approaches to improve the quality of life of grandparent caregivers.",2021,"Results:  Grandparents in the intervention group, in comparison to the waiting list control group, reduced their level of depression, improved their parental efficacy, overall psychosocial adjustment, and increased their ability to choose effective goals.",['Methods : Fifty-two grandparents'],"['6-session solution-oriented goal-setting program or to a waiting list control condition who subsequently received the intervention', 'psychosocial intervention program']","['level of depression', 'health and social psychological outcomes', 'parental efficacy, overall psychosocial adjustment']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0337471', 'cui_str': 'Grandparent'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]",52.0,0.0215509,"Results:  Grandparents in the intervention group, in comparison to the waiting list control group, reduced their level of depression, improved their parental efficacy, overall psychosocial adjustment, and increased their ability to choose effective goals.","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Montoro-Rodriguez', 'Affiliation': 'Department of Gerontology, 14727University of North Carolina at Charlotte, Charlotte, NC, USA.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Hayslip', 'Affiliation': 'Department of Psychology, 3404University of North Texas, Denton, TX, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ramsey', 'Affiliation': 'Department of Gerontology, 14727University of North Carolina at Charlotte, Charlotte, NC, USA.'}, {'ForeName': 'Jane L', 'Initials': 'JL', 'LastName': 'Jooste', 'Affiliation': '41618Lewisville Independent School District, Lewisville, TX, USA.'}]",Journal of aging and health,['10.1177/08982643211004817']
659,33784233,Chronotropic Index and Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Secondary Analysis of BLOCK COPD.,"Rationale:  The chronotropic index quantifies the proportion of the expected heart rate increase that is attained during exercise. The relationship between the chronotropic index and acute exacerbations of chronic obstructive pulmonary disease (AECOPDs) has not been evaluated.  Objectives:  To determine whether a higher chronotropic index during a 6-minute walk (CI-6MW) is associated with lower risk of AECOPD and whether the CI-6MW is a marker of susceptibility to adverse effects of metoprolol in chronic obstructive pulmonary disease (COPD).  Methods:  We analyzed data from the BLOCK COPD (Beta-Blockers for the Prevention of AECOPDs) trial. We used Cox proportional hazards models to investigate the relationship between the CI-6MW and the time to AECOPDs. We also tested for interactions between study group assignment (metoprolol vs. placebo) and the CI-6MW on the time to AECOPDs.  Results:  Four hundred seventy-seven participants with exacerbation-prone COPD (mean forced expiratory volume in 1 second, 41% of predicted) were included in this analysis. A higher CI-6MW was independently associated with a decreased risk of AECOPDs of any severity (adjusted hazard ratio per 0.1 increase in CI-6MW of 0.88; 95% confidence interval, 0.80-0.96) but was not independently associated with AECOPDs requiring hospitalization (adjusted hazard ratio, 0.94; 95% confidence interval, 0.81-1.05). There was a significant interaction by treatment assignment, and in a stratified analysis, the protective effects of a higher CI-6MW on AECOPDs were negated by metoprolol use.  Conclusions:  A higher CI-6MW is associated with a decreased risk of AECOPDs and may be an indicator of susceptibility to the adverse effects of metoprolol.",2021,"Higher CI-6MW was independently associated with a decreased risk of AECOPD of any severity (adjusted hazard ratio per 0.1 increase in CI-6MW of 0.88; 95% CI: 0.80 to 0.96), but not AECOPD requiring hospitalization (aHR 0.94; 95% CI: 0.81 to 1.05).",['477 participants with exacerbation prone COPD (mean FEV1 41% of predicted'],"['metoprolol vs placebo', 'metoprolol']","['Chronotropic Index and Acute Exacerbations of COPD', 'risk of AECOPD of any severity']","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",477.0,0.245978,"Higher CI-6MW was independently associated with a decreased risk of AECOPD of any severity (adjusted hazard ratio per 0.1 increase in CI-6MW of 0.88; 95% CI: 0.80 to 0.96), but not AECOPD requiring hospitalization (aHR 0.94; 95% CI: 0.81 to 1.05).","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'MacDonald', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, and.'}, {'ForeName': 'Erika S', 'Initials': 'ES', 'LastName': 'Helgeson', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Selcuk', 'Initials': 'S', 'LastName': 'Adabag', 'Affiliation': 'Cardiology Section, and.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-University of California Los Angeles Medical Center, Torrance, California; and.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stringer', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-University of California Los Angeles Medical Center, Torrance, California; and.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Voelker', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Ken M', 'Initials': 'KM', 'LastName': 'Kunisaki', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, and.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202008-1085OC']
660,33783013,Early language screening and intervention can be delivered successfully at scale: evidence from a cluster randomized controlled trial.,"BACKGROUND


It is well established that oral language skills provide a critical foundation for formal education. This study evaluated the effectiveness of the Nuffield Early Language Intervention (NELI) programme in ameliorating language difficulties in the first year of school when delivered at scale.
METHODS


We conducted a cluster randomized controlled trial (RCT) in 193 primary schools (containing 238 Reception classrooms). Schools were randomly allocated to either a 20-week oral language intervention or a business-as-usual control group. All classes (N = 5,879 children) in participating schools were screened by school staff using an automated App to assess children's oral language skills. Screening identified 1,173 children as eligible for language intervention: schools containing 571 of these children were allocated to the control group and 569 to the intervention group.
RESULTS


Children receiving the NELI programme made significantly larger gains than the business-as-usual control group on a latent variable reflecting standardized measures of language ability (d = .26) and on the school-administered automated assessment of receptive and expressive language skills (d = .32). The effects of intervention did not vary as a function of home language background or gender.
CONCLUSIONS


This study provides strong evidence for the effectiveness of a school-based language intervention programme (NELI) delivered at scale. These findings demonstrate that language difficulties can be identified by school-based testing and ameliorated by a TA delivered intervention; this has important implications for educational and social policy.",2021,"RESULTS


Children receiving the NELI programme made significantly larger gains than the business-as-usual control group on a latent variable reflecting standardized measures of language ability (d = .26) and on the school-administered automated assessment of receptive and expressive language skills (d = .32).","[""All classes (N\xa0=\xa05,879 children) in participating schools were screened by school staff using an automated App to assess children's oral language skills"", '1,173 children as eligible for language intervention: schools containing 571 of these children were allocated to the control group and 569 to the intervention group', '193 primary schools (containing 238 Reception classrooms', 'Children receiving the']","['school-based language intervention programme (NELI', '20-week oral language intervention or a business-as-usual control group', 'Nuffield Early Language Intervention (NELI) programme', 'NELI programme']","['school-administered automated assessment of receptive and expressive language skills', 'language ability']","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",5879.0,0.0966574,"RESULTS


Children receiving the NELI programme made significantly larger gains than the business-as-usual control group on a latent variable reflecting standardized measures of language ability (d = .26) and on the school-administered automated assessment of receptive and expressive language skills (d = .32).","[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'West', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Snowling', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Lervåg', 'Affiliation': 'University of Oslo, Oslo, Norway.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Buchanan-Worster', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Duta', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Elklan Training Ltd, Cornwall, UK.'}, {'ForeName': 'Henrietta', 'Initials': 'H', 'LastName': 'McLachlan', 'Affiliation': 'Elklan Training Ltd, Cornwall, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'University of Oxford, Oxford, UK.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13415']
661,33782992,Effectiveness of a venous thromboembolism course using flipped classroom with nursing students: A randomized controlled trial.,"BACKGROUND


Modern innovative education approaches are crucial for nursing education, which leads to improving evidence-based teaching strategies and preparing nursing students for their future workplaces. The primary aim of the study was a comparison of the effectiveness of the flipped classroom and traditional educational methods on the attainment of knowledge regarding venous thromboembolism (VTE) prevention among nursing students. In addition, investigation of the opinions of the nursing students regarding the advantages and disadvantages flipped classroom educational method was the secondary aim of the study.
METHODS


This study was implemented with a randomized controlled design in the Faculty of Nursing in September and October 2019, with 118 first- and second-semester undergraduate nursing students (58 students in the flipped classroom, 60 students in the traditional lecture) who had not taken the Adult Health Nursing course. Implementation of the study was conducted in three phases: pretest, educational intervention, and posttest for both groups.
RESULTS


The study findings demonstrated no statistically significant difference in any of the mean scores of VTE domains between the two groups in the pretest. However, the flipped classroom group had higher mean scores of all VTE domains compared with the traditional lecture group in the posttest. Mostly, students highlighted four advantages of the flipped classroom, including ""Deep motive,"" ""Engagement,"" ""Cost-effectiveness,"" and ""Self-confidence.""
CONCLUSIONS


The flipped classroom method proved to have positive effects in VTE domains in terms of knowledge, risk assessment, and prophylaxis among nursing students. This method can be recommended as an innovative and student-centered method in the teaching of evidence-based nursing practices.",2021,"The flipped classroom method proved to have positive effects in VTE domains in terms of knowledge, risk assessment, and prophylaxis among nursing students.","['flipped classroom with nursing students', 'Faculty of Nursing in September and October 2019, with 118 first- and second-semester undergraduate nursing students (58 students in the flipped classroom, 60 students in the traditional lecture) who had not taken the Adult Health Nursing course', 'nursing students']",['flipped classroom and traditional educational methods'],['mean scores of VTE domains'],"[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.0706514,"The flipped classroom method proved to have positive effects in VTE domains in terms of knowledge, risk assessment, and prophylaxis among nursing students.","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Al-Mugheed', 'Affiliation': 'Faculty of Nursing, Surgical Nursing Department, Near East University, Nicosia, Cyprus.'}, {'ForeName': 'Nurhan', 'Initials': 'N', 'LastName': 'Bayraktar', 'Affiliation': 'Faculty of Nursing, Surgical Nursing Department, Near East University, Nicosia, Cyprus.'}]",Nursing forum,['10.1111/nuf.12573']
662,33785415,Systemic Conditions Associated with Severity of Dry Eye Signs and Symptoms in the Dry Eye Assessment and Management Study.,"PURPOSE


Certain systemic conditions are reported to be risk factors for dry eye disease (DED), but their associations with DED severity are not well studied. We evaluated whether systemic conditions reported to be DED risk factors are associated with severity of DED signs and symptoms.
DESIGN


Secondary analysis of data from the Dry Eye Assessment and Management Study, a large-scale multicenter randomized clinical trial of patients with moderate to severe DED.
PARTICIPANTS


Five hundred thirty-five adult patients with moderate to severe DED from 27 United States centers.
METHODS


Patients reported their medical history at baseline. They underwent ocular surface examinations and symptom evaluation using standardized protocols at baseline, 6 months, and 12 months. We analyzed the associations of systemic conditions (a systemic disease or smoking history) reported as potential DED risk factors with the severity of DED signs and symptoms using generalized linear regression models adjusted by age, gender, race, and visit.
MAIN OUTCOME MEASURES


Dry eye disease symptoms assessed using the Ocular Surface Disease Index (OSDI), 6 DED signs (tear film break-up time, anesthetized Schirmer testing, corneal fluorescein staining, conjunctival lissamine green staining, tear osmolarity, and meibomian gland dysfunction), and a composite signs severity score from 0 to 1 (1 = most severe).
RESULTS


The mean age was 58 years; 81% were women. More severe DED signs were associated significantly with Sjögren syndrome (mean composite signs severity score 0.52 with disease vs. 0.43 without disease; P < 0.001), facial rosacea (0.47 vs. 0.43; P = 0.002), rheumatoid arthritis (0.47 vs. 0.42; P = 0.002), peripheral artery disease (0.50 vs. 0.43; P < 0.001), and daily smoking history (0.45 vs. 0.43; P = 0.047). Thyroid dysfunction, osteoarthritis, diabetes, irritable bowel syndrome, hypercholesterolemia, hypertension, and hypertriglyceridemia were not associated significantly with DED signs. No conditions were associated significantly with OSDI.
CONCLUSIONS


In this large, well-characterized cohort of patients with DED assessed under standardized procedures, patients with certain systemic diseases and smoking history showed more severe DED signs compared with patients without the conditions. The profile of significant DED signs varied by systemic condition, reflecting different DED causes. Understanding the systemic conditions and underlying causes that predispose some patients to severe DED can improve management.",2021,More severe DED signs were significantly associated with Sjögren's syndrome (mean±SD of composite signs,"['Patients reported their medical history at baseline', 'The mean±SD age was 58±13.2 years, and 81% were female', 'patients with moderate-to-severe DED', '535 adult patients with moderate-to-severe DED from 27 US centers']",[],"['facial rosacea', 'daily smoking history', 'OSDI', 'DED symptoms assessed using the Ocular Surface Disease Index (OSDI), six DED signs (tear break-up time, anesthetized Schirmer testing, corneal fluorescein staining, conjunctival lissamine green staining, tear osmolarity, and meibomian gland dysfunction), and a composite signs severity score', 'Thyroid dysfunction, osteoarthritis, diabetes, irritable bowel syndrome, hypercholesterolemia, hypertension, and hypertriglyceridemia', 'peripheral artery disease', 'severe DED signs', 'rheumatoid arthritis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],"[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0348024', 'cui_str': 'Thyroid dysfunction'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]",535.0,0.094907,More severe DED signs were significantly associated with Sjögren's syndrome (mean±SD of composite signs,"[{'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Vatinee', 'Initials': 'V', 'LastName': 'Bunya', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Asbell', 'Affiliation': 'Department of Ophthalmology, University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: gsying@pennmedicine.upenn.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2021.03.030']
663,33792726,Stabilization Exercises Versus Flexion Exercises in Degenerative Spondylolisthesis: A Randomized Controlled Trial.,"OBJECTIVE


Exercise is the mainstay of treatment in individuals with low back pain and the first-line option in degenerative spondylolisthesis (DS); however, there is still no consensus surrounding the superiority of any specific exercise program. Thus, the primary aim of this study was to compare the effectiveness of lumbar stabilization exercises and flexion exercises for pain control and improvements of disability in individuals with chronic low back pain (CLBP) and DS.
METHODS


A randomized controlled trial was conducted in a tertiary public hospital and included 92 individuals over the age of 50 years who were randomly allocated to lumbar stabilization exercises or flexion exercises. Participants received 6 sessions of physical therapy (monthly appointments) and were instructed to execute exercises daily at home during the 6 months of the study. The primary outcome (measured at baseline, 1 month, 3 months, and 6 months) was pain intensity (visual analog scale, 0-100 mm) and disability (Oswestry Disability Index, from 0% to 100%). Secondary outcomes were disability (Roland-Morris Disability Questionnaire, from 0 to 24 points), changes in body mass index, and flexibility (fingertip to floor, in centimeters) at baseline and 6 months, and also the total of days of analgesic use at 6-month follow-up.
RESULTS


Mean differences between groups were not significant (for lumbar pain: 0.56 [95% CI = -11.48 to 12.61]; for radicular pain: -1.23 [95% CI = -14.11 to 11.64]; for Oswestry Disability Index: -0.61 [95% CI = -6.92 to 5.69]; for Roland-Morris Disability Questionnaire: 0.53 [95% CI = -1.69 to 2.76]).
CONCLUSION


The findings from the present study reveal that flexion exercises are not inferior to and offer a similar response to stabilization exercises for the control of pain and improvements of disability in individuals with CLBP and DS.
IMPACT


Exercise is the mainstay of treatment in individuals with CLBP and DS; however, there is still no consensus surrounding the superiority of any specific exercise program. This study finds that flexion exercises are not inferior to and offer a similar response to stabilization exercises.
LAY SUMMARY


Exercise is the mainstay of treatment in individuals with CLBP and DS, but there is no consensus on the superiority of any specific exercise program. If you have DS, flexion exercises may provide similar effects to stabilization exercises.",2021,"Mean differences between groups were not significant (for lumbar pain: 0.56 [95% CI = -11.48 to 12.61]; for radicular pain: -1.23 [95% CI = -14.11 to 11.64]; for ODI: -0.61 [95% CI = -6.92 to 5.69]; for Roland-Morris Disability Questionnaire: 0.53 [95% CI = -1.69 to 2.76]).
","['tertiary public hospital and included 92 patients over the age of 50 who were randomly allocate to', 'patients with low back pain and the first-line option in degenerative spondylolisthesis', 'Degenerative Spondylolisthesis', 'patients with chronic low back pain and degenerative spondylolisthesis']","['lumbar stabilization exercises and flexion exercises', 'Exercise', 'Stabilization Exercises Versus Flexion Exercises', 'stabilization exercises', 'lumbar stabilization exercises or flexion exercises', 'flexion exercises', 'six session of physical therapy']","['disability (Roland-Morris Disability Questionnaire, from 0 to 24 points), changes in body mass index, and flexibility (fingertip to floor, in centimeters', 'total of days of analgesic use', 'pain intensity (visual analog scale, from 0 to 100\xa0mm) and disability (Oswestry Disability Index']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0264184', 'cui_str': 'Degenerative spondylolisthesis'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0729895', 'cui_str': 'Tip of finger'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",,0.097014,"Mean differences between groups were not significant (for lumbar pain: 0.56 [95% CI = -11.48 to 12.61]; for radicular pain: -1.23 [95% CI = -14.11 to 11.64]; for ODI: -0.61 [95% CI = -6.92 to 5.69]; for Roland-Morris Disability Questionnaire: 0.53 [95% CI = -1.69 to 2.76]).
","[{'ForeName': 'Tania Inés', 'Initials': 'TI', 'LastName': 'Nava-Bringas', 'Affiliation': 'Department of Orthopedic Rehabilitation, Instituto Nacional de Rehabilitation ""Luis Guillermo Ibarra"", México City, Mexico.'}, {'ForeName': 'Lizbeth Olivia', 'Initials': 'LO', 'LastName': 'Romero-Fierro', 'Affiliation': 'Departamento de Rehabilitación, Hospital Naval de Tapachula, Tapachula, Chiapas, México.'}, {'ForeName': 'Yessica Patricia', 'Initials': 'YP', 'LastName': 'Trani-Chagoya', 'Affiliation': 'Departamento de Rehabilitación, Hospital General Naval de Lázaro Cárdenas, Lázaro Cárdenas, Michoacán, México.'}, {'ForeName': 'Salvador Israel', 'Initials': 'SI', 'LastName': 'Macías-Hernández', 'Affiliation': 'Department of Orthopedic Rehabilitation, Instituto Nacional de Rehabilitation ""Luis Guillermo Ibarra"", México City, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'García-Guerrero', 'Affiliation': 'Departments of Physical Therapies, Instituto Nacional de Rehabilitación ""Luis Guillermo Ibarra"".'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Hernández-López', 'Affiliation': 'Departments of Physical Therapies, Instituto Nacional de Rehabilitación ""Luis Guillermo Ibarra"".'}, {'ForeName': 'Coronado-Zarco', 'Initials': 'CZ', 'LastName': 'Roberto', 'Affiliation': 'Department of Orthopedic Rehabilitation, Instituto Nacional de Rehabilitation ""Luis Guillermo Ibarra"", México City, Mexico.'}]",Physical therapy,['10.1093/ptj/pzab108']
664,33242697,"Preventing asthma in high risk kids (PARK) with omalizumab: Design, rationale, methods, lessons learned and adaptation.","Asthma remains one of the most important challenges to pediatric public health in the US. A large majority of children with persistent and chronic asthma demonstrate aeroallergen sensitization, which remains a pivotal risk factor associated with the development of persistent, progressive asthma throughout life. In individuals with a tendency toward Type 2 inflammation, sensitization and exposure to high concentrations of offending allergens is associated with increased risk for development of, and impairment from, asthma. The cascade of biological responses to allergens is primarily mediated through IgE antibodies and their production is further stimulated by IgE responses to antigen exposure. In addition, circulating IgE impairs innate anti-viral immune responses. The latter effect could magnify the effects of another early life exposure associated with increased risk of the development of asthma - viral infections. Omalizumab binds to circulating IgE and thus ablates antigen signaling through IgE-related mechanisms. Further, it has been shown restore IFN-α response to rhinovirus and to reduce asthma exacerbations during the viral season. We therefore hypothesized that early blockade of IgE and IgE mediated responses with omalizumab would prevent the development and reduce the severity of asthma in those at high risk for developing asthma. Herein, we describe a double-blind, placebo-controlled trial of omalizumab in 2-3 year old children at high risk for development of asthma to prevent the development and reduce the severity of asthma. We describe the rationale, methods, and lessons learned in implementing this potentially transformative trial aimed at prevention of asthma.",2021,"In individuals with a tendency toward Type 2 inflammation, sensitization and exposure to high concentrations of offending allergens is associated with increased risk for development of, and impairment from, asthma.","['children with persistent and chronic asthma', '2-3\u202fyear old children at high risk for development of asthma']","['placebo', 'Omalizumab', 'omalizumab']","['circulating IgE impairs innate anti-viral immune responses', 'risk of the development of asthma - viral infections']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0877430', 'cui_str': 'Asthma chronic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}]",,0.103326,"In individuals with a tendency toward Type 2 inflammation, sensitization and exposure to high concentrations of offending allergens is associated with increased risk for development of, and impairment from, asthma.","[{'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Boston Children's Hospital, Division of Allergy and Immunology, United States of America; Harvard Medical School, Boston, MA, United States of America. Electronic address: wanda.phipatanakul@childrens.harvard.edu.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': 'Pennsylvania State University, Hershey, PA, United States of America.'}, {'ForeName': 'Theresa W', 'Initials': 'TW', 'LastName': 'Guilbert', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States of America.""}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""Washington University and St. Louis Children's Hospital, St. Louis, MO, United States of America.""}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States of America.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Jackson', 'Affiliation': 'University of Wisconsin, Madison, WI, United States of America.'}, {'ForeName': 'Fernando D', 'Initials': 'FD', 'LastName': 'Martinez', 'Affiliation': 'Asthma and Airway Research Center, University of Arizona, Tucson, AZ, United States of America.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fitzpatrick', 'Affiliation': 'Emory University, Department of Pediatrics Atlanta, Georgia.'}, {'ForeName': 'Amparito', 'Initials': 'A', 'LastName': 'Cunningham', 'Affiliation': ""Boston Children's Hospital, Division of Allergy and Immunology, United States of America.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kunselman', 'Affiliation': 'Pennsylvania State University, Hershey, PA, United States of America.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Wheatley', 'Affiliation': 'NIH/National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States of America.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Bauer', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, AZ, United States of America.""}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Davis', 'Affiliation': ""Baylor College of Medicine, Texas Children's Hospital, Houston, TX, United States of America.""}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Geng', 'Affiliation': ""Rady Children's Hospital, UC San Diego, San Diego, CA, United States of America.""}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Kloepfer', 'Affiliation': 'Riley Hospital for Children at IU Health, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Lapin', 'Affiliation': ""Connecticut Children's Medical Center, Division of Pulmonary Hartford, CT, United States of America.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Liu', 'Affiliation': ""Children's Hospital Colorado, University of Colorado, Aurora, CO, United States of America.""}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Pongracic', 'Affiliation': ""Ann and Robert Lurie Children's Hospital of Chicago, Chicago, IL, United States of America.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Teach', 'Affiliation': ""Children's National Hospital, Washington, DC, United States of America.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chmiel', 'Affiliation': 'NIH/National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States of America.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Gaffin', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Boston Children's Hospital, Division of Pulmonary Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Greenhawt', 'Affiliation': ""Children's Hospital Colorado, University of Colorado, Aurora, CO, United States of America.""}, {'ForeName': 'Meera R', 'Initials': 'MR', 'LastName': 'Gupta', 'Affiliation': ""Baylor College of Medicine, Texas Children's Hospital, Houston, TX, United States of America.""}, {'ForeName': 'Peggy S', 'Initials': 'PS', 'LastName': 'Lai', 'Affiliation': 'Harvard Medical School, Boston, MA, United States of America; Massachusetts General Hospital, Division of Pulmonary and Critical Care, Boston, MA, United States of America.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Lemanske', 'Affiliation': 'University of Wisconsin, Madison, WI, United States of America.'}, {'ForeName': 'Wayne J', 'Initials': 'WJ', 'LastName': 'Morgan', 'Affiliation': 'Asthma and Airway Research Center, University of Arizona, Tucson, AZ, United States of America.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sheehan', 'Affiliation': ""Children's National Hospital, Washington, DC, United States of America.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Stokes', 'Affiliation': ""Washington University and St. Louis Children's Hospital, St. Louis, MO, United States of America.""}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Thorne', 'Affiliation': 'University of Iowa, College of Public Health, Department of Occupational and Environmental Health, Iowa City, IA, United States of America.'}, {'ForeName': 'Hans C', 'Initials': 'HC', 'LastName': 'Oettgen', 'Affiliation': ""Boston Children's Hospital, Division of Allergy and Immunology, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Brigham and Women's Hospital, Divisions of Pulmonary and Critical Care Medicine and Allergy and Immunology, Boston, MA, United States of America.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106228']
665,33785233,"Immediate effect of mechanical lumbar traction in patients with chronic low back pain: A crossover, repeated measures, randomized controlled trial.","BACKGROUND


Lumbar traction is a treatment method traditionally used for chronic low back pain (CLBP) in many countries. However, its clinical effectiveness has not been proven in medical practice. The purpose is to conduct a multi-center, crossover, randomized controlled trial (RCT) to prove the efficacy and safety of traction on CLBP patients, using equipment capable of precise traction force control and of reproducibility of the condition based on the previous biomechanical and pre-clinical studies.
METHODS


Ninety-five patients with non-specific CLBP from 28 clinics and hospitals were randomly assigned to either the intermittent traction with vibration (ITV) first group (A: sequence ITV to ITO) or the intermittent traction only (ITO) first group (B: sequence ITO to ITV); the former was treated with repeated traction and vibration force added to preload. All patients were followed up weekly for 2 periods after study-initiation. The primary outcome measures were disability level including pain and quality of life (based on Japan Low back pain Evaluation Questionnaire; JLEQ), and JLEQ was measured repeatedly. Statistical analysis was performed using linear mixed model.
RESULTS


Comparing to pre-traction data, both traction modes significant improvement except the first intervention of ITO treatment. The differences in JLEQ scores over time showed significant improvements in the treatment to which vibrational force was added in contrast to the conventional traction treatment; Mean difference was significant to compare ITV treatment and ITO treatment (-1.75 (p = 0.001), 95% CI; -2.69 to -0.80). However, neither difference between the two sequences (p = 0.884) nor carryover effect (p = 0.527) was observed.
CONCLUSIONS


Altogether, the results indicate that lumbar traction was able to improve the pain and functional status immediately in patients with CLBP. This study contributes to add some evidence of the efficacy of lumbar traction.",2021,"However, neither difference between the two sequences (p = 0.884) nor carryover effect (p = 0.527) was observed.
","['patients with CLBP', 'Ninety-five patients with non-specific CLBP from 28 clinics and hospitals', 'patients with chronic low back pain']","['lumbar traction', 'mechanical lumbar traction', 'intermittent traction with vibration (ITV) first group (A: sequence ITV to ITO) or the intermittent traction only (ITO) first group (B: sequence ITO to ITV); the former was treated with repeated traction and vibration force added to preload']","['carryover effect', 'disability level including pain and quality of life (based on Japan Low back pain Evaluation Questionnaire; JLEQ), and JLEQ', 'JLEQ scores', 'pain and functional status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}]","[{'cui': 'C0556666', 'cui_str': 'Lumbar traction'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0565524', 'cui_str': 'Intermittent traction'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",95.0,0.0622565,"However, neither difference between the two sequences (p = 0.884) nor carryover effect (p = 0.527) was observed.
","[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Tanabe', 'Affiliation': 'Tanabe Orthopaedic Clinic, 3-2-16 Narimasu, Itabashi-ku, Tokyo 175-0094, Japan. Electronic address: narimasu@mint.ocn.ne.jp.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Akai', 'Affiliation': 'Graduate School, International University of Health and Welfare, 4-1-26 Akasaka, Minato-ku, Tokyo 107-8402, Japan. Electronic address: akai-masami@iuhw.ac.jp.'}, {'ForeName': 'Tokuhide', 'Initials': 'T', 'LastName': 'Doi', 'Affiliation': 'Geriatric Care Facility Narita Tomisato Tokushu-en, 1-1-1 Hiyoshi-dai, Tomisato-shi, Chiba 286-0201, Japan. Electronic address: doi@mars.dti.ne.jp.'}, {'ForeName': 'Sadao', 'Initials': 'S', 'LastName': 'Arai', 'Affiliation': 'Arai Orthopaedic Clinic, 1-19-7 Asumigaoka Midori-ku, Chiba-shi, Chiba 267-0066, Japan. Electronic address: ryokusei@fb3.so-net.ne.jp.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Fujino', 'Affiliation': 'Fujino Orthopaedic Clinic, 2-15-12 Johoku, Naka-ku, Hamamatsu-shi, Shizuoka 432-8011, Japan. Electronic address: keifujino@lily.ocn.ne.jp.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Department of Statistical Epidemiology, School of Health Sciences, Gunma University, 3-39-22 Shouwa-machi, Maebashi-shi, Gunma 371-8514, Japan. Electronic address: khayashi@health.gunma-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2020.09.018']
666,33785589,Using random assignment to measure court accessibility for low-income divorce seekers.,"We conducted a field experiment in which 311 low-income individuals seeking a divorce were randomly assigned to receive access to a pro bono lawyer (versus minimal help) to assist with filing for divorce. Examining court records, we found that assignment to an attorney made a large difference in whether participants filed for and obtained a divorce. Three years after randomization, 46% of the treated group had terminated their marriages in the proper legal venue, compared to 9% of the control group. Among ""compliers""-participants who obtained representation only if assigned to receive it-those with lawyers were far more likely to file for and obtain a divorce than those not assigned lawyers. Because divorce implicates fundamental constitutional interests and can be effectuated only by resort to the courts, the US Constitution requires that dissolution of marriage be made achievable regardless of ability to pay. Yet, we observed few low-income individuals who were able to initiate divorce suits on their own. Through interviews and archival research, we identified barriers that low-income litigants faced in navigating the divorce system, including mandatory wait times, limited hours at important facilities, and burdensome paperwork sometimes requiring access to photocopiers and typewriters. This study therefore documents a salient instance in which a civil legal process was inaccessible to those without lawyers, even though their legal issues were straightforward, involving few if any matters for courts to adjudicate.",2021,"Through interviews and archival research, we identified barriers that low-income litigants faced in navigating the divorce system, including mandatory wait times, limited hours at important facilities, and burdensome paperwork sometimes requiring access to photocopiers and typewriters.",['311 low-income individuals seeking a divorce'],['pro bono lawyer (versus minimal help) to assist with filing for divorce'],[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0012828', 'cui_str': 'Divorce'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0086530', 'cui_str': 'Lawyer'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0012828', 'cui_str': 'Divorce'}]",[],311.0,0.0973381,"Through interviews and archival research, we identified barriers that low-income litigants faced in navigating the divorce system, including mandatory wait times, limited hours at important facilities, and burdensome paperwork sometimes requiring access to photocopiers and typewriters.","[{'ForeName': 'D James', 'Initials': 'DJ', 'LastName': 'Greiner', 'Affiliation': 'Harvard Law School, Harvard University, Cambridge, MA 02138; jgreiner@law.harvard.edu.'}, {'ForeName': 'Ellen Lee', 'Initials': 'EL', 'LastName': 'Degnan', 'Affiliation': 'Southern Poverty Law Center, Montgomery, AL 36104.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ferriss', 'Affiliation': 'Access to Justice Lab at Harvard Law School, Cambridge, MA 02138.'}, {'ForeName': 'Roseanna', 'Initials': 'R', 'LastName': 'Sommers', 'Affiliation': 'University of Michigan Law School, Ann Arbor, MI 48109.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2009086118']
667,33238857,GLP-1RA and SGLT2i: Cardiovascular Impact on Diabetic Patients.,"BACKGROUND


Diabetes is a chronic disease with high complexity that demands strategic medical care with a multifactorial risk-reduction approach. Over the past decade, the treatment of type 2 diabetes mellitus (T2DM) has entirely changed. One of the paradigm changes has been the arrival of new drugs that reduce cardiovascular risk beyond the reduction of A1C.
OBJECTIVE


Sodium-glucose cotransporter 2 (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP-1RA) are two groups of antidiabetics drugs, which have demonstrated superiority compared to placebo for major cardiovascular events (MACE).
METHODS


We update and discuss their impact on MACE expressed as relative risk (HR hazard ratio) and as the number needed to treat (NNT) to avoid one cardiovascular event in 5 years. We include the publications of the last 10 years.
RESULTS


Empagliflozin, Canagliflozin and Dapagliflozin present an HR for MACE of 0.86, 0.86, 0.86 and an NNT of 38, 44, and 33, respectively (Dapagliflozin in secondary prevention). Regarding HHF (Hospitalization for Heart Failure), the HR was 0.65, 0.67, 0.73 and NNT was 44, 62, and 98, respectively. Lixisenatide, Exenatide, Liragutide, Semaglutide, Albiglutide and Dulaglutide presented for MACE an HR of 1.02, 0.91, 0.87, 0.74, 0.78, 0.88, respectively. There was no increase in the risk of HHF, but there was no benefit either.
CONCLUSION


Cardiovascular benefits of the GLP-1RA and the SGLT2i are clinically significant. A number needed to treat under 50 is required to avoid one MACE in five years. These benefits have led to important changes in the Clinical Practice Guidelines and in the care of our patients with T2DM.",2021,"There was no increase in the risk of HHF, but there was no benefit either.
","['Diabetic Patients', 'Regarding HHF (Hospitalization for Heart Failure']","['Empagliflozin, Canagliflozin and Dapagliflozin', 'placebo', 'GLP-1RA and SGLT2i']","['risk of HHF', 'Cardiovascular Impact']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.0492695,"There was no increase in the risk of HHF, but there was no benefit either.
","[{'ForeName': 'Aschner', 'Initials': 'A', 'LastName': 'Pablo', 'Affiliation': 'Department of Endocrinology, Javeriana University School of Medicine and San Ignacio University Hospital, Bogota, Colombia.'}, {'ForeName': 'Blanc', 'Initials': 'B', 'LastName': 'Evelyn', 'Affiliation': 'Diabetes and Metabolism Department, Favaloro Foundation, University Hospital, Buenos Aires, Argentina.'}, {'ForeName': 'Folino', 'Initials': 'F', 'LastName': 'Claudia', 'Affiliation': 'Diabetes and Metabolism Department, Favaloro Foundation, University Hospital, Buenos Aires, Argentina.'}, {'ForeName': 'Morosán A', 'Initials': 'MA', 'LastName': 'Yanina', 'Affiliation': 'Diabetes and Metabolism Department, Favaloro Foundation, University Hospital, Buenos Aires, Argentina.'}]",Current hypertension reviews,['10.2174/1573402116999201124123549']
668,33250396,Role of strengthening during nonoperative treatment of lateral epicondyle tendinopathy.,"INTRODUCTION


Lateral epicondyle tendinopathy (LET) is the most common cause of lateral elbow pain. The literature on rehabilitation of the condition encompasses a plethora of interventions with most current evidence indicating that stretches and some form of strengthening are vital components. However, patient outcomes are infrequently reported further than 12 weeks from the start of therapy and it is unclear which components of a home exercise program are necessary to alleviate symptoms up to one year from the initiation of a therapy program.
PURPOSE OF THE STUDY


The purpose of the study is to determine if a therapy program with 4 to 6 visits spaced out over 12 weeks focusing on self-management and strengthening is more effective in reducing pain and improving function long term than the same program without strengthening, for individuals with LET.
STUDY DESIGN


This is a randomized controlled trial.
METHODS


Ninety-four patients were randomly allocated into two groups: both groups received the interventions of education in pertinent pathoanatomy, stretching, pain management through rest and icing, and activity modification. Group 1 (n = 38) was also provided with a strengthening component to the home exercise program, whereas group 2 did not (n = 21). Our primary outcome measure was pain at rest and pain with activity; our secondary measure was the level of functional impairment as measured by the quick disabilities of arm shoulder and hand. Outcome measurements were assessed at baseline, 6, 12, 24, and 52 weeks after initiation of therapy.
RESULTS


Both groups demonstrated statistically significant improvement with a moderate to large effect size in pain and function scores when compared with previous time point at 6, 12, and 24 weeks. Pain continued to decrease for both groups from 24 weeks to 52 weeks, but interestingly, there was a significant increase with moderate effect size in the quick disabilities of arm shoulder and hand score at 52 weeks when compared with week 24. No statistically significant difference was found between the two groups at any time point up to 52 weeks from the start of therapy.
CONCLUSIONS


This study demonstrates that a therapy program consisting of a low number of visits spaced out over 12 weeks based on education, stretches, activity modification, and pain management techniques is effective at reducing pain and increasing function in patients with LET. The addition of strengthening to this program did not improve outcomes. The therapy approach used in this study is consistent with the International Classification of Function guidelines and focuses on engaging patients in self-management of the condition through patient education and self-empowerment.",2021,"No statistically significant difference was found between the two groups at any time point up to 52 weeks from the start of therapy.
","['individuals with LET', 'lateral epicondyle tendinopathy', 'patients with LET', 'Ninety-four patients']","['interventions of education in pertinent pathoanatomy, stretching, pain management through rest and icing, and activity modification', 'strengthening component to the home exercise program']","['pain and function scores', 'quick disabilities of arm shoulder and hand score', 'Pain', 'pain at rest and pain with activity', 'level of functional impairment as measured by the quick disabilities of arm shoulder and hand']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0222681', 'cui_str': 'Structure of epicondyle'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",94.0,0.0511868,"No statistically significant difference was found between the two groups at any time point up to 52 weeks from the start of therapy.
","[{'ForeName': 'Kathryn S', 'Initials': 'KS', 'LastName': 'McQueen', 'Affiliation': 'Washington University School of Medicine, Program of Occupational Therapy, Milliken Hand Rehabilitation Center, Saint Louis, MO, USA. Electronic address: Kmcqueen@wustl.edu.'}, {'ForeName': 'Rhonda K', 'Initials': 'RK', 'LastName': 'Powell', 'Affiliation': 'Washington University School of Medicine, Program of Occupational Therapy, Milliken Hand Rehabilitation Center, Saint Louis, MO, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Keener', 'Affiliation': 'Washington University School of Medicine, Program of Occupational Therapy, Milliken Hand Rehabilitation Center, Saint Louis, MO, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whalley', 'Affiliation': 'Washington University School of Medicine, Program of Occupational Therapy, Saint Louis, MO, USA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Calfee', 'Affiliation': 'Department of Orthopedic Surgery, Washington University School of Medicine, Saint Louis, MO, USA.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.10.009']
669,33247774,BIO-NAIL: a bacterial cellulose dressing as a new alternative to preserve the nail bed after avulsion.,"Avulsion of the nail plate is the most accomplished surgical procedure among the nail apparatus surgeries. Since it is not possible to use the removed nail to cover the nail bed, some materials have been suggested, however, they are generally not available for use and often at a high cost. To evaluate the use of Bacterial Cellulose (BC) dressing as a biological nail (Bio-Nail) after partial or total avulsion of the nail plate. Twenty-six candidates for nail avulsion, were randomized into two groups: Control, using Vaseline with gauze (11 patients) and Experimental group, BC group, using the Bio-Nail (15 patients). The patients were followed up during the 180-day period. The distribution of the patients in the groups was homogeneous for both sociodemographic and clinical data. The occurrence of infection (1 case in the control group) was not statistically relevant. The BC group had lower pain intensity (p = 0.011) with earlier temporal resolution when compared to the control group (p = 0.003). The BC group presented earlier reepithelization (p = 0.022) and better quantitative (p = 0.021) and qualitative conditions (p = 0.011) for the exudate. Regarding satisfaction, all the patients were satisfied. Good preservation of the nail plate area was observed in the BC group at the end of the 180-day period (p = 0.024). Average time of BC dressing permanence was 16.4 ± 7.1 days. BC showed to be appropriate as a dressing after partial or total avulsion of the nail plate. BC is a Bio-Nail promising for nail bed healing.",2020,The BC group had lower pain intensity (p = 0.011) with earlier temporal resolution when compared to the control group (p = 0.003).,['Twenty-six candidates for nail avulsion'],"['Vaseline with gauze', 'Bacterial Cellulose (BC) dressing']","['occurrence of infection', 'Average time of BC dressing permanence', 'nail plate area', 'earlier reepithelization', 'lower pain intensity']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0191722', 'cui_str': 'Removal of nail'}]","[{'cui': 'C0728774', 'cui_str': 'Vaseline'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0547050', 'cui_str': 'Permanences'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",26.0,0.0183412,The BC group had lower pain intensity (p = 0.011) with earlier temporal resolution when compared to the control group (p = 0.003).,"[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Oliveira', 'Affiliation': 'Department of Dermatology, Hospital das Clínicas, Department of Surgery, Health Sciences Center, Federal University of Pernambuco, UFPE, Pernambuco, Brazil.'}, {'ForeName': 'F C M', 'Initials': 'FCM', 'LastName': 'Pinto', 'Affiliation': 'Post-Graduation Program in Surgery, Department of Surgery, Health Sciences Center, Federal University of Pernambuco, UFPE, Pernambuco, Brazil. fcmorone@gmail.com.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Ferraz-Carvalho', 'Affiliation': 'Post-Graduation Program in Surgery, Department of Surgery, Health Sciences Center, Federal University of Pernambuco, UFPE, Pernambuco, Brazil.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Albuquerque', 'Affiliation': 'Post-Graduation Program in Surgery, Department of Surgery, Health Sciences Center, Federal University of Pernambuco, UFPE, Pernambuco, Brazil.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Aguiar', 'Affiliation': 'Post-Graduation Program in Surgery, Department of Surgery, Health Sciences Center, Federal University of Pernambuco, UFPE, Pernambuco, Brazil.'}]",Journal of materials science. Materials in medicine,['10.1007/s10856-020-06456-9']
670,33251697,Metabolic and sympathovagal effects of bolus insulin glulisine versus basal insulin glargine therapy in people with type 2 diabetes: A randomized controlled study.,"AIMS/INTRODUCTION


This study compares the effects of two different insulin regimens - basal versus bolus insulin - on metabolic and cardiovascular autonomic function in Japanese participants with type 2 diabetes.
MATERIALS AND METHODS


Participants were randomly assigned to groups for therapy with insulin glulisine (IGlu) or insulin glargine (IGla). The primary efficacy end-point was glycemic variability, including M-values, mean of glucose levels, and a blood glucose profile of seven time points before and after the intervention. The secondary end-points included pleiotropic effects, including endothelial and cardiac autonomic nerve functions.
RESULTS


Blood glucose levels at all time points significantly decreased in both groups. Post-lunch, post-dinner, and bedtime blood glucose levels were significantly lower in the IGlu group than in the IGla group. Nadir fasting blood glucose levels at the end-point were significantly lower in the IGla group than in the IGlu group. The M-value and mean blood glucose levels were significantly decreased from baseline in both groups, although the former was significantly lower in the IGlu group than in the IGla group. IGla, but not IGlu, was found to elevate 24-h parasympathetic tone, especially during night-time, and it decreased 24-h sympathetic nerve activity, especially at dawn.
CONCLUSIONS


Both IGlu and IGla regimens reduced glucose variability, with IGlu bringing a greater reduction in M-value. IGla, but not IGlu, increased parasympathetic tone during night-time and decreased sympathetic nerve activity at dawn. These findings shed light on the previously unrecognized role of night-time basal insulin supplementation on sympathovagal activity in type 2 diabetes patients.",2021,Nadir fasting blood glucose levels at the endpoint were significantly lower in the IGla group than in the IGlu group.,"['Japanese participants with type 2 diabetes', 'Participants', 'people with type 2 diabetes']","['bolus insulin glulisine versus basal insulin glargine therapy', 'insulin regimens-basal versus bolus insulin', 'insulin glulisine (IGlu) or insulin glargine (IGla']","['glycemic variability, including M-values, mean of glucose levels, and a blood glucose profile of seven time points', 'pleiotropic effects, including endothelial and cardiac autonomic nerve functions', '24-hour parasympathetic tone', 'Blood glucose levels', 'parasympathetic tone during nighttime and decreased sympathetic nerve activity', 'glucose variability', 'Metabolic and sympathovagal effects', 'Nadir fasting blood glucose levels', 'metabolic and cardiovascular autonomic function', 'sympathovagal activity', 'M-value and mean blood glucose levels', '24-hour sympathetic nerve activity', 'bedtime blood glucose levels']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1313386', 'cui_str': 'Insulin, Glulisine, Human'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0206250', 'cui_str': 'Autonomic nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]",,0.0185758,Nadir fasting blood glucose levels at the endpoint were significantly lower in the IGla group than in the IGlu group.,"[{'ForeName': 'Yumie', 'Initials': 'Y', 'LastName': 'Takeshita', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Wakakuri', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kita', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Kanamori', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Takamura', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13471']
671,33249802,Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI).,"BACKGROUND/AIMS


We aimed to evaluate the efficacy and safety of ustekinumab (UST) in the East-Asian population with moderate to severely active ulcerative colitis (UC).
METHODS


This sub-analysis was conducted on data from East-Asian patients included in the UNIFI program (NCT02407236). UNIFI consisted of two double-blind, placebo-controlled trials: an 8-week induction study and a 44-week randomized withdrawal maintenance study.
RESULTS


Of 133 East-Asian patients (Japanese: 107, Korean: 26) who underwent randomization, 131 completed induction study and 111 entered maintenance study. In the maintenance study, 78 patients were randomized. Patients who received UST 130 mg and UST 6 mg/kg showed numerically higher clinical remission at week 8 in the induction study (5/44 [11.4%] and 5/45 [11.1%], respectively) compared with those who received placebo (0/44, 0%). The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%). Serious adverse events were reported in 1 patient in UST 130 mg group, but no patient in UST 6 mg/kg group through week 8 in the induction study, and 1 patient in UST 90 mg q12w group and 5 patients in the UST 90 mg q8w group in the maintenance study. No deaths were reported in East-Asian patients throughout the study.
CONCLUSIONS


UST induction and maintenance treatments were effective in East-Asian patients with moderate to severe UC; the efficacy and safety profiles were consistent with the overall population.",2021,"The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%).","['East-Asian population with moderate to severely active ulcerative colitis (UC', 'East-Asian patients with moderate to severe UC', '133 East-Asian patients (Japanese: 107, Korean: 26) who underwent randomization, 131 completed induction study and 111 entered maintenance study', '78 patients were randomized', 'East Asian patients with moderately to severely active ulcerative colitis', 'East-Asian patients included in the UNIFI program (NCT02407236']","['UST 130 mg and UST', 'UST', 'ustekinumab (UST', 'placebo', 'ustekinumab']","['proportion of patients achieved clinical remission', 'Efficacy and safety', 'clinical remission', 'deaths', 'Serious adverse events']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",78.0,0.152079,"The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%).","[{'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hyo Jong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ""Center for Crohn's and Colitis, Department of Gastroenterology, Kyung Hee University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Motoya', 'Affiliation': 'IBD Center, Hokkaido Prefectural Welfare Federation of Agricultural Cooperative, Sapporo-Kosei General Hospital, Hokkaido, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Ohnishi', 'Affiliation': 'Division of Gastroenterology, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Nobuko', 'Initials': 'N', 'LastName': 'Matsushima', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Richuan', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Colleen W', 'Initials': 'CW', 'LastName': 'Marano', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}]",Intestinal research,['10.5217/ir.2020.00080']
672,33249580,Migraine Headache Day Response Rates and the Implications to Patient Functioning: An Evaluation of 3 Randomized Phase 3 Clinical Trials of Galcanezumab in Patients With Migraine.,"OBJECTIVE


This post hoc study investigated the relationship between patient response in terms of migraine headache day reduction and patient-reported outcomes of health-related quality of life (HRQoL) and disability categories.
BACKGROUND


Migraine causes considerable disease-related disability and negatively impacts HRQoL of patients. Calcitonin gene-related peptide inhibitors improve these outcomes and may eliminate disability due to migraine in some patients.
METHODS


Analyses used data from 3 double-blind, placebo (PBO)-controlled, phase 3 studies in adults with episodic migraine (EM) (EVOLVE-1: N = 858 and EVOLVE-2: N = 915) or chronic migraine (CM) (REGAIN: N = 1113). Patients were randomized 2:1:1 to subcutaneous injection of PBO, galcanezumab (GMB) 120 mg, or GMB 240 mg once monthly for 6 months in EVOLVE-1 and -2 and for 3 months in REGAIN. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Patients were divided into 4 response-level groups based on percent change from baseline (<30%, ≥30% to <50%, ≥50% to <75%, ≥75%). Patient-reported outcomes included the 14-item Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) and Migraine Disability Assessment (MIDAS) questionnaire.
RESULTS


Among patients with migraine, mean improvements from baseline in MSQ domain scores increased with each successive level of migraine headache day response. On a 100-pt scale, increases in Role Function-Restrictive score in EM were 16.8 and 36.0 at the <30% and ≥75% response levels, respectively, and for CM were 10.7 and 46.5. Similar patterns in scores were observed for the Role Function-Preventive and Emotional Function domains. Examination of improvement in MSQ item score by treatment group showed that, in patients with EM, approximately 10 to 20% more GMB-treated patients (N = 796 for GMB 120 mg and GMB 240 mg) had improvements in all 14 MSQ items compared with PBO-treated patients (N = 773) (all P < .001). In patients with CM, 3 to 16% more GMB-treated patients (N = 507) had improvements in the 14 MSQ items compared with PBO (N = 494), though differences were statistically significant in only 19 of 28 comparisons. At baseline, mean MIDAS scores (EM, 33.1; CM, 67.2) indicated severe mean disability for patients with EM and very severe disability for patients with CM. Among patients with EM, 215 of 425 (50.6%) of those treated with GMB 120 mg and 212 of 413 (51.3%) treated with 240 mg had little/no disability due to migraine after 6 months (PBO: 277 of 832 (33.3%), P < .001 for both). Among patients with CM, 50 of 254 (19.7%) of those treated with GMB 120 mg and 54 of 258 (20.9%) treated with 240 mg reached the level of little/no disability after 3 months of treatment (PBO: 70 of 504 (13.9%), P = .045 for 120 mg, P = .017 for 240 mg).
CONCLUSIONS


Because migraine greatly impairs an individual's ability to participate in activities of daily living, measurements of HRQoL are essential in clinical research. This study showed that function in daily life, as measured by MSQ score, improved as migraine headache days were reduced and that GMB-treated patients were more likely to see improvement in MSQ item scores compared with PBO-treated patients. Elimination of migraine-related disability was also more frequent in GMB-treated patients compared with placebo-treated patients.",2020,"Among patients with migraine, mean improvements from baseline in MSQ domain scores increased with each successive level of migraine headache day response.","['Patients With Migraine', 'Patient Functioning', 'adults with episodic migraine (EM) ']","['subcutaneous injection of PBO, galcanezumab (GMB', 'placebo', 'EVOLVE-1', 'Calcitonin', 'chronic migraine (CM', 'Galcanezumab', 'placebo (PBO)-controlled', 'GMB']","['MSQ item scores', 'overall mean change from baseline in monthly migraine headache days', 'Elimination of migraine-related disability', 'Migraine Headache Day Response Rates', 'severe mean disability', 'MSQ domain scores', 'Role Function-Restrictive score in EM', 'MSQ item score', 'migraine headache days', 'mean MIDAS scores', 'MSQ score', '14-item Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) and Migraine Disability Assessment (MIDAS) questionnaire', 'severe disability', 'level of little/no disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}]","[{'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0006668', 'cui_str': 'Calcitonin'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C1309950', 'cui_str': 'GOLPH3 protein, human'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}]",1113.0,0.0741682,"Among patients with migraine, mean improvements from baseline in MSQ domain scores increased with each successive level of migraine headache day response.","[{'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kurth', 'Affiliation': 'Institute of Public Health, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Amaal J', 'Initials': 'AJ', 'LastName': 'Starling', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Ayer', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Wietecha', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Martha D', 'Initials': 'MD', 'LastName': 'Port', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Mallikarjuna', 'Initials': 'M', 'LastName': 'Rettiganti', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'Ruff', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.14013']
673,34126564,Comparison of intravascular access methods applied by nurses wearing personal protective equipment in simulated COVID-19 resuscitation: A randomized crossover simulation trial.,"BACKGROUND


Prehospital emergency care of children is challenging. In the era of the COVID-19 pandemic, when medical personnel should use personal protective equipment against aerosol-generating procedures, the efficiency of medical procedures may decrease. The study objective was to evaluate the effectiveness of different intravascular access methods applied by nurses wearing biosafety Level-2 suits in simulated paediatric COVID-19 resuscitation.
METHODS


A prospective, randomized, crossover, single-blinded simulation trial was performed. Nursing staff attending Advanced Cardiovascular Life Support courses accredited by the American Heart Association participated in the study. A total of 65 nurses were recruited and randomly assigned to different study groups. They received standard training on intravascular access methods employing distinct devices. The participants wore biosafety Level-2 suits and performed vascular access with the following intraosseous devices: NIO-P, EZ-IO, and Jamshidi needle; intravenous (IV) access was used as a reference method. Both the order of participants and the access methods were random. Each participant performed intravascular access with each of the four methods tested. The effectiveness of the first attempt to obtain intravascular access and the following time parameters were analysed: the time between grasping the intravascular device out of the original packing until infusion line connection. The ease of the procedure was measured with a visual analogue scale (1 - easy; 10 - difficult).
RESULTS


The first attempt success rate of intravascular access by using NIO-P and EZ-IO equalled 100% and was statistically significantly higher than that with the Jamshidi needle (80.0%; p = 0.02) and with the IV method (69.2%; p = 0.005). The time required to connect the infusion line varied and amounted to 33 ± 4 s for NIO-P compared to 37 ± 6.7 s for EZ-IO (p<0.001), 43 ± 7 s for Jamshidi (p<0.001), and 98.5 ± 10 s for IV access (p<0.001). The procedure was easiest in the case of NIO-P and EZ-IO (2 ± 1 points; p=1.0) compared with Jamshidi (5 ± 3 points; p<0.001) and IV access (7 ± 2 points; p<0.001).
CONCLUSION


The study provides evidence that nurses wearing biosafety Level-2 suits were able to obtain intraosseous access faster and more effectively as compared with IV access during simulated COVID-19 paediatric resuscitation. The most effective method of intravascular access was the NIO-P intraosseous device. Further clinical trials are necessary to confirm the results.",2021,The first attempt success rate of intravascular access by using NIO-P and EZ-IO equalled 100% and was statistically significantly higher than that with the Jamshidi needle (80.0%; p = 0.02) and with the IV method (69.2%; p = 0.005).,"['A total of 65 nurses', 'Nursing staff attending Advanced Cardiovascular Life Support courses accredited by the American Heart Association participated in the study', 'nurses wearing personal protective equipment in simulated COVID-19 resuscitation']",['standard training'],['visual analogue scale'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",65.0,0.114819,The first attempt success rate of intravascular access by using NIO-P and EZ-IO equalled 100% and was statistically significantly higher than that with the Jamshidi needle (80.0%; p = 0.02) and with the IV method (69.2%; p = 0.005).,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Drozd', 'Affiliation': 'Polish Society of Disaster Medicine, Warsaw, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Smereka', 'Affiliation': 'Department of Emergency Medical Service, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Pruc', 'Affiliation': 'Polish Society of Disaster Medicine, Warsaw, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Malysz', 'Affiliation': 'Polish Society of Disaster Medicine, Warsaw, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Gasecka', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands; 1st Chair and Department of Cardiology, Medical University of Warsaw, Poland.'}, {'ForeName': 'Leyla Ozturk', 'Initials': 'LO', 'LastName': 'Sonmez', 'Affiliation': 'Department of Emergency Medicine, Beyhekim Training and Research Hospital, Konya, Turkey.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Cyran', 'Affiliation': 'Maria Sklodowska-Curie Medical Academy in Warsaw, Poland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Konge', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation, Centre for HR and Education, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Szarpak', 'Affiliation': 'Polish Society of Disaster Medicine, Warsaw, Poland; Maria Sklodowska-Curie Bialystok Oncology Center, Bialystok, Poland. Electronic address: Lukasz.szarpak@gmail.com.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.05.080']
674,34120912,"A Randomized, Double-Blind, Placebo-Controlled, Global Phase 3 Study of Edasalonexent in Pediatric Patients with Duchenne Muscular Dystrophy: Results of the PolarisDMD Trial.","BACKGROUND


Edasalonexent (CAT-1004) is an orally-administered novel small molecule drug designed to inhibit NF-κB and potentially reduce inflammation and fibrosis to improve muscle function and thereby slow disease progression and muscle decline in Duchenne muscular dystrophy (DMD).
OBJECTIVE


This international, randomized 2 : 1, placebo-controlled, phase 3 study in patients ≥4 - < 8 years old with DMD due to any dystrophin mutation examined the effect of edasalonexent (100 mg/kg/day) compared to placebo over 52 weeks.
METHODS


Endpoints were changes in the North Star Ambulatory Assessment (NSAA; primary) and timed function tests (TFTs; secondary). Assessment of health-related function used the Pediatric Outcomes Data Collection tool (PODCI).
RESULTS


One hundred thirty one patients received edasalonexent (n = 88) and placebo (n = 43). At week 52, differences between edasalonexent and placebo for NSAA total score and TFTs were not statistically significant, although there were consistently less functional declines in the edasalonexent group. A pre-specified analysis by age demonstrated that younger patients (≤6.0 years) showed more robust and statistically significant differences between edasalonexent and placebo for some assessments. Treatment was well-tolerated and the majority of adverse events were mild, and most commonly involved the gastrointestinal system (primarily diarrhea).
CONCLUSIONS


Edasalonexent was generally well-tolerated with a manageable safety profile at the dose of 100 mg/kg/day. Although edasalonexent did not achieve statistical significance for improvement in primary and secondary functional endpoints for assessment of DMD, subgroup analysis suggested that edasalonexent may slow disease progression if initiated before 6 years of age. (NCT03703882).",2021,"Although edasalonexent did not achieve statistical significance for improvement in primary and secondary functional endpoints for assessment of DMD, subgroup analysis suggested that edasalonexent may slow disease progression if initiated before 6 years of age.","['One hundred thirty one patients received', 'patients ≥4\u200a-\u200a< \u200a8 years old with DMD due to any dystrophin mutation examined the effect of', 'Pediatric Patients with Duchenne Muscular Dystrophy']","['edasalonexent', 'edasalonexent and placebo', 'Edasalonexent', 'Placebo', 'placebo']","['functional declines', 'North Star Ambulatory Assessment (NSAA; primary) and timed function tests (TFTs; secondary', 'NSAA total score and TFTs']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0079259', 'cui_str': 'Dystrophin'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C4548371', 'cui_str': 'edasalonexent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.380195,"Although edasalonexent did not achieve statistical significance for improvement in primary and secondary functional endpoints for assessment of DMD, subgroup analysis suggested that edasalonexent may slow disease progression if initiated before 6 years of age.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finkel', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN and Nemours Children's Hospital, Orlando, FL, USA.""}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': 'University of California at Davis, Sacramento, CA, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lee Sweeney', 'Affiliation': 'University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Finanger', 'Affiliation': 'Shriners Hospital for Children, Portland, OR, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Neil Knierbein', 'Affiliation': 'University of Michigan, MI, Ann Arbor, MI, USA.'}, {'ForeName': 'Kathryn R', 'Initials': 'KR', 'LastName': 'Wagner', 'Affiliation': 'Kennedy Krieger Institute, The Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Mathews', 'Affiliation': 'University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Marks', 'Affiliation': ""Cook Children's Medical Center, Fort Worth, TX, USA.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Statland', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Nance', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Hugh J', 'Initials': 'HJ', 'LastName': 'McMillan', 'Affiliation': ""Children's Hospital of Eastern Ontario, Ottawa, CA, Canada.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'McCullagh', 'Affiliation': ""Royal Manchester Children's Hospital, UK.""}, {'ForeName': 'Cuixia', 'Initials': 'C', 'LastName': 'Tian', 'Affiliation': ""Cincinnati Children's Hospital & University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Monique M', 'Initials': 'MM', 'LastName': 'Ryan', 'Affiliation': ""Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': ""O'Rourke"", 'Affiliation': ""Children's Health Ireland at Temple Street, Dublin, Ireland.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Müller-Felber', 'Affiliation': 'Dr. v. Haunersches Kinderspital, Munich, Germany.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Tulinius', 'Affiliation': ""Queen Silvia Children's Hospital, Gothenburg, Sweden.""}, {'ForeName': 'W Bryan', 'Initials': 'WB', 'LastName': 'Burnette', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Cam-Tu', 'Initials': 'CT', 'LastName': 'Nguyen', 'Affiliation': 'CHU Sainte-Justine, Montreal, CA, Canada.'}, {'ForeName': 'Kayal', 'Initials': 'K', 'LastName': 'Vijayakumar', 'Affiliation': ""Bristol Children's Hospital, Bristol, UK.""}, {'ForeName': 'Jessika', 'Initials': 'J', 'LastName': 'Johannsen', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Han C', 'Initials': 'HC', 'LastName': 'Phan', 'Affiliation': 'Rare Disease Research, LLC, Atlanta, GA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Eagle', 'Affiliation': 'Atom International Limited, Newcastle upon Tyne, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacDougall', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Catabasis Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Donovan', 'Affiliation': 'Catabasis Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neuromuscular diseases,['10.3233/JND-210689']
675,34125080,Driving Pressure-Guided Individualized Positive End-Expiratory Pressure in Abdominal Surgery: A Randomized Controlled Trial.,"BACKGROUND


The optimal positive end-expiratory pressure (PEEP) to prevent postoperative pulmonary complications (PPCs) remains unclear. Recent evidence showed that driving pressure was closely related to PPCs. In this study, we tested the hypothesis that an individualized PEEP guided by minimum driving pressure during abdominal surgery would reduce the incidence of PPCs.
METHODS


This single-centered, randomized controlled trial included a total of 148 patients scheduled for open upper abdominal surgery. Patients were randomly assigned to receive an individualized PEEP guided by minimum driving pressure or an empiric fixed PEEP of 6 cm H2O. The primary outcome was the incidence of clinically significant PPCs within the first 7 days after surgery, using a χ2 test. Secondary outcomes were the severity of PPCs, the area of atelectasis, and pleural effusion. Other outcomes, such as the incidence of different types of PPCs (including hypoxemia, atelectasis, pleural effusion, dyspnea, pneumonia, pneumothorax, and acute respiratory distress syndrome), intensive care unit (ICU) admission rate, length of hospital stay, and 30-day mortality were also explored.
RESULTS


The median value of PEEP in the individualized group was 10 cm H2O. The incidence of clinically significant PPCs was significantly lower in the individualized PEEP group compared with that in the fixed PEEP group (26 of 67 [38.8%] vs 42 of 67 [62.7%], relative risk = 0.619, 95% confidence intervals, 0.435-0.881; P = .006). The overall severity of PPCs and the area of atelectasis were also significantly diminished in the individualized PEEP group. Higher respiratory compliance during surgery and improved intra- and postoperative oxygenation was observed in the individualized group. No significant differences were found in other outcomes between the 2 groups, such as ICU admission rate or 30-day mortality.
CONCLUSIONS


The application of individualized PEEP based on minimum driving pressure may effectively decrease the severity of atelectasis, improve oxygenation, and reduce the incidence of clinically significant PPCs after open upper abdominal surgery.",2021,"No significant differences were found in other outcomes between the 2 groups, such as ICU admission rate or 30-day mortality.
","['148 patients scheduled for open upper abdominal surgery', 'Abdominal Surgery']","['individualized PEEP', 'Driving Pressure-Guided Individualized Positive End-Expiratory Pressure', 'individualized PEEP guided by minimum driving pressure or an empiric fixed PEEP of 6 cm']","['severity of PPCs, the area of atelectasis, and pleural effusion', 'median value of PEEP', 'incidence of clinically significant PPCs', 'intra- and postoperative oxygenation', 'Higher respiratory compliance', 'incidence of different types of PPCs (including hypoxemia, atelectasis, pleural effusion, dyspnea, pneumonia, pneumothorax, and acute respiratory distress syndrome), intensive care unit (ICU) admission rate, length of hospital stay, and 30-day mortality', 'ICU admission rate or 30-day mortality', 'overall severity of PPCs and the area of atelectasis']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",148.0,0.474169,"No significant differences were found in other outcomes between the 2 groups, such as ICU admission rate or 30-day mortality.
","[{'ForeName': 'Chengmi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Xinhua Hospital, affiliated with Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fengying', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, No. 971 Hospital of People's Liberation Army Navy, Qingdao, China.""}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Xinhua Hospital, affiliated with Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xingyu', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Xinhua Hospital, affiliated with Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xia', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Xinhua Hospital, affiliated with Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Xinhua Hospital, affiliated with Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jianer', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Xinhua Hospital, affiliated with Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xueyin', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Xinhua Hospital, affiliated with Shanghai Jiaotong University School of Medicine, Shanghai, China.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005575']
676,34126249,Predominantly Persistent Subretinal Fluid in the Comparison of Age-Related Macular Degeneration Treatments Trials.,"OBJECTIVE


To describe predominantly persistent subretinal fluid (SRF) in eyes receiving ranibizumab or bevacizumab for neovascular age-related macular degeneration and to compare visual acuity (VA) to eyes with nonpersistent SRF.
DESIGN


Cohort within randomized clinical trial.
PARTICIPANTS


Comparison of Age-related Macular Degeneration Treatments Trials patients assigned to pro re nata treatment.
METHODS


Graders evaluated monthly OCT scans for SRF. Predominantly persistent SRF through week 12 was defined as SRF at baseline and weeks 4, 8, and 12. Predominantly persistent SRF through 1 or 2 years was defined as SRF in 80% or more of visits by years 1 or 2, respectively. Linear regression models including baseline predictors of VA and predominantly persistent intraretinal fluid (IRF) were used to evaluate mean differences in vision outcomes.
PRIMARY OUTCOME MEASURES


Predominantly persistent SRF through year 1, adjusted VA score and VA change, and foveal SRF thickness.
RESULTS


Among 406 eyes with baseline SRF, SRF persisted in 108 eyes (26.6%) through week 12, in 94 eyes (23.2%) through year 1, and in 77 eyes (19.0%) through year 2. Adjusted VA means at year 1 were similar between eyes with predominantly persistent versus non persistent SRF by week 12 (68.1 vs. 70.2 letters; P = 0.18), year 1 (67.6 vs. 70.2 letters; P = 0.11), and year 2 (71.4 vs. 70.9 letters; P = 0.78). Adjusted changes in mean VA at year 1 were similar between eyes with predominantly persistent versus nonpersistent SRF by week 12 (6.3 vs. 7.6 letters; P = 0.38), year 1 (5.5 vs. 7.8 letters; P = 0.14), and year 2 (8.1 vs. 7.7 letters; P = 0.78). Among eyes with predominantly persistent SRF through year 1, foveal SRF was absent in 46 eyes (48.9%), thickness was 1 to 200 μm in 48 eyes (50.0%) and more than 200 μm in 1 eye (1.1%) at year 1.
CONCLUSIONS


Eyes with predominantly persistent and nonpersistent SRF through week 12, year 1, or year 2 showed similar VA outcomes after adjustment for baseline covariates and persistent IRF. At the foveal center, predominantly persistent SRF was most commonly absent or present in small quantities.",2021,"Adjusted VA means (letters) at year 1 were similar between eyes with predominantly persistent vs. non-persistent SRF by week 12, (68.1 vs. 70.2; P=0.18), year 1 (67.6 vs. 70.2; P=0.11), and year 2 (71.4 vs. 70.9; P=0.78).",['for neovascular age-related macular degeneration and compare visual acuity (VA) to eyes with non-persistent SRF'],"['ranibizumab or bevacizumab', 'pro re nata (PRN) treatment']","['SRF thickness', 'optical coherence tomography scans']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",406.0,0.209368,"Adjusted VA means (letters) at year 1 were similar between eyes with predominantly persistent vs. non-persistent SRF by week 12, (68.1 vs. 70.2; P=0.18), year 1 (67.6 vs. 70.2; P=0.11), and year 2 (71.4 vs. 70.9; P=0.78).","[{'ForeName': 'Jason Q', 'Initials': 'JQ', 'LastName': 'Core', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Pistilli', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ebenezer', 'Initials': 'E', 'LastName': 'Daniel', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Grunwald', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Toth', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Peiying', 'Initials': 'P', 'LastName': 'Hua', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, and National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: maguirem@pennmedicine.upenn.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2021.06.003']
677,34032604,"Early Neurologic Recovery, Practice Pattern Variation, and the Risk of Endotracheal Intubation Following Established Status Epilepticus.","OBJECTIVE


To quantify the association between early neurologic recovery, practice pattern variation, and endotracheal intubation during established status epilepticus, we performed a secondary analysis within the cohort of patients enrolled in the Established Status Epilepticus Treatment Trial (ESETT).
METHODS


We evaluated factors associated with the endpoint of endotracheal intubation occurring within 120 minutes of ESETT study drug initiation. We defined a blocked, stepwise multivariate regression, examining 4 phases during status epilepticus management: (1) baseline characteristics, (2) acute treatment, (3) 20-minute neurologic recovery, and (4) 60-minute recovery, including seizure cessation and improving responsiveness.
RESULTS


Of 478 patients, 117 (24.5%) were intubated within 120 minutes. Among high-enrolling sites, intubation rates ranged from 4% to 32% at pediatric sites and 19% to 39% at adult sites. Baseline characteristics, including seizure precipitant, benzodiazepine dosing, and admission vital signs, provided limited discrimination for predicting intubation (area under the curve [AUC] 0.63). However, treatment at sites with an intubation rate in the highest (vs lowest) quartile strongly predicted endotracheal intubation independently of other treatment variables (adjusted odds ratio [aOR] 8.12, 95% confidence interval [CI] 3.08-21.4, model AUC 0.70). Site-specific variation was the factor most strongly associated with endotracheal intubation after adjustment for 20-minute (aOR 23.4, 95% CI 6.99-78.3, model AUC 0.88) and 60-minute (aOR 14.7, 95% CI 3.20-67.5, model AUC 0.98) neurologic recovery.
CONCLUSIONS


Endotracheal intubation after established status epilepticus is strongly associated with site-specific practice pattern variation, independently of baseline characteristics, and early neurologic recovery and should not alone serve as a clinical trial endpoint in established status epilepticus.
TRIAL REGISTRATION INFORMATION


ClinicalTrials.gov Identifier: NCT01960075.",2021,"Baseline characteristics, including seizure precipitant, benzodiazepine dosing, and admission vital signs, provided limited discrimination for predicting intubation (area under the curve [AUC] 0.63).","['Of 478 patients, 117 (24.5%) were intubated within 120 minutes', 'patients enrolled in the Established Status Epilepticus Treatment Trial (ESETT']",[],"['neurologic recovery, and (4) 60-minute recovery, including seizure cessation and improving responsiveness', 'Early Neurologic Recovery, Practice Pattern Variation, and the Risk of Endotracheal Intubation', 'intubation rates', 'endotracheal intubation', 'seizure precipitant, benzodiazepine dosing, and admission vital signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",478.0,0.495345,"Baseline characteristics, including seizure precipitant, benzodiazepine dosing, and admission vital signs, provided limited discrimination for predicting intubation (area under the curve [AUC] 0.63).","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Rosenthal', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC. erosenthal@mgh.harvard.edu.""}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Elm', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ingles', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Terndrup', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Holsti', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Danny G', 'Initials': 'DG', 'LastName': 'Thomas', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Babcock', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Okada', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lipsky', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Miller', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Hickey', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Barra', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Bleck', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Cloyd', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Lowenstein', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Coles', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Kapur', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Shinnar', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000011879']
678,34131048,Baseline Predictors of Glycemic Worsening in Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes in the Restoring Insulin Secretion (RISE) Study.,"OBJECTIVE


To identify predictors of glycemic worsening among youth and adults with impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes in the Restoring Insulin Secretion (RISE) Study.
RESEARCH DESIGN AND METHODS


A total of 91 youth (10-19 years) were randomized 1:1 to 12 months of metformin (MET) or 3 months of glargine, followed by 9 months of metformin (G-MET), and 267 adults were randomized to MET, G-MET, liraglutide plus MET (LIRA+MET), or placebo for 12 months. All participants underwent a baseline hyperglycemic clamp and a 3-h oral glucose tolerance test (OGTT) at baseline, month 6, month 12, and off treatment at month 15 and month 21. Cox models identified baseline predictors of glycemic worsening (HbA 1c  increase ≥0.5% from baseline).
RESULTS


Glycemic worsening occurred in 17.8% of youth versus 7.5% of adults at month 12 ( P  = 0.008) and in 36% of youth versus 20% of adults at month 21 ( P  = 0.002). In youth, glycemic worsening did not differ by treatment. In adults, month 12 glycemic worsening was less on LIRA+MET versus placebo (hazard ratio 0.21, 95% CI 0.05-0.96,  P  = 0.044). In both age-groups, lower baseline clamp-derived β-cell responses predicted month 12 and month 21 glycemic worsening ( P  < 0.01). Lower baseline OGTT-derived β-cell responses predicted month 21 worsening ( P  < 0.05). In youth, higher baseline HbA 1c  and 2-h glucose predicted month 12 and month 21 glycemic worsening, and higher fasting glucose predicted month 21 worsening ( P  < 0.05). In adults, lower clamp- and OGTT-derived insulin sensitivity predicted month 12 and month 21 worsening ( P  < 0.05).
CONCLUSIONS


Glycemic worsening was more common among youth than adults with IGT or recently diagnosed type 2 diabetes, predicted by lower baseline β-cell responses in both groups, hyperglycemia in youth, and insulin resistance in adults.",2021,"In adults, month 12 glycemic worsening was less on LIRA+MET versus placebo (hazard ratio 0.21, 95% CI 0.05-0.96,  P  = 0.044).","['A total of 91 youth (10-19 years', 'youth and adults with impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes in the Restoring Insulin Secretion (RISE) Study', '267 adults', 'Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes in the Restoring Insulin Secretion (RISE) Study']","['LIRA+MET versus placebo', 'liraglutide plus MET (LIRA+MET), or placebo', 'metformin (MET) or 3 months of glargine, followed by 9 months of metformin (G-MET', 'baseline hyperglycemic clamp and a 3-h oral glucose tolerance test (OGTT']",['Glycemic worsening'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517672', 'cui_str': '267'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}]",267.0,0.277001,"In adults, month 12 glycemic worsening was less on LIRA+MET versus placebo (hazard ratio 0.21, 95% CI 0.05-0.96,  P  = 0.044).","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sam', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Silva A', 'Initials': 'SA', 'LastName': 'Arslanian', 'Affiliation': ""University of Pittsburgh Medical Center-Children's Hospital of Pittsburgh, Pittsburgh, PA.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barengolts', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'University of Southern California Keck School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ehrmann', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ashley Hogan', 'Initials': 'AH', 'LastName': 'Tjaden', 'Affiliation': 'George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tripputi', 'Affiliation': 'George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Anny H', 'Initials': 'AH', 'LastName': 'Xiang', 'Affiliation': 'Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc21-0027']
679,34129596,Early Cerebral Hypoperfusion in Patients with Orthostatic Intolerance Without Tachycardia During Head-Up Tilt Test is Independent of Vasovagal Response.,"BACKGROUND


Cerebral hypoperfusion before syncope has been shown in patients with chronic orthostatic intolerance (OI) without tachycardia, but it is unknown if an initial decrease of cerebral blood flow velocity (CBFv) could be related to the vasovagal response (VVR) to head-up tilt test (HUTT).
OBJECTIVE


The objective of the study was to compare cardiovascular, cerebrovascular, and autonomic variables during HUTT in OI patients with or without a VVR.
METHODS


We included 74 subjects (58% female, mean age 33 ± 12 years) who underwent a 30-min HUTT and were divided into three groups: OI with VVR positive (VVR+), OI without VVR negative (VVR-), and asymptomatic healthy subjects with negative HUTT (control group). Cardiovascular, cerebrovascular, and autonomic variables were assessed beat-to-beat during HUTT with a Task Force monitor and a trans-cranial Doppler. Mean values were evaluated at baseline and throughout the first 10 min of tilting.
RESULTS


Cardiovascular variables were similar in the three groups. Systolic, diastolic, and mean CBFv were similar in VVR+ and VVR-, but both groups had lower CBFv than the control group. Systolic and diastolic CBFv decreased from baseline since min 1 in VVR+ and VVR- and since min 5 in the control group. The mean CBFv had a significant decrease since min 1 compared to baseline in all groups. Spectral indices of heart rate and blood pressure variability showed a similar autonomic response to HUTT in all groups.
CONCLUSION


Patients with chronic OI without tachycardia have early postural cerebral hypoperfusion, regardless of the VVR during HUTT.",2021,"Spectral indices of heart rate and blood pressure variability showed a similar autonomic response to HUTT in all groups.
","['Patients with Orthostatic Intolerance Without Tachycardia', 'asymptomatic healthy subjects with negative HUTT (control group', '74 subjects (58% female, mean age 33 ± 12 years) who underwent a 30-min HUTT and were divided into three groups', 'patients with chronic orthostatic intolerance (OI) without tachycardia', 'OI patients with or without a VVR']","['OI with VVR positive (VVR+), OI without VVR negative (VVR']","['heart rate and blood pressure variability', 'mean CBFv', 'cardiovascular, cerebrovascular, and autonomic variables', 'Systolic and diastolic CBFv', 'Cardiovascular, cerebrovascular, and autonomic variables', 'cerebral blood flow velocity (CBFv', 'Systolic, diastolic, and mean CBFv', 'Mean values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0242880', 'cui_str': 'Tilt table test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",74.0,0.0227325,"Spectral indices of heart rate and blood pressure variability showed a similar autonomic response to HUTT in all groups.
","[{'ForeName': 'J Antonio', 'Initials': 'JA', 'LastName': 'González-Hermosillo', 'Affiliation': 'Department of Cardiovascular Dysautonomia, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Rubio-Vega', 'Affiliation': 'Department of Cardiovascular Dysautonomia, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.'}, {'ForeName': 'Karla A F', 'Initials': 'KAF', 'LastName': 'González-Olvera', 'Affiliation': 'Department of Cardiovascular Dysautonomia, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Sierra-Beltrán', 'Affiliation': 'Department of Cardiovascular Dysautonomia, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Kostine', 'Affiliation': 'Department of Cardiovascular Dysautonomia, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lerma', 'Affiliation': 'Department of Electromechanical Instrumentation, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.'}]",Revista de investigacion clinica; organo del Hospital de Enfermedades de la Nutricion,['10.24875/RIC.21000199']
680,34135015,Effect of Medical and Surgical Interventions on α-Cell Function in Dysglycemic Youth and Adults in the RISE Study.,"OBJECTIVE


To compare effects of medications and laparoscopic gastric band surgery (LB) on α-cell function in dysglycemic youth and adults in the Restoring Insulin Secretion (RISE) Study protocols.
RESEARCH DESIGN AND METHODS


Glucagon was measured in three randomized, parallel, clinical studies:  1 ) 91 youth studied at baseline, after 12 months on metformin alone (MET) or glargine followed by metformin (G/M), and 3 months after treatment withdrawal;  2 ) 267 adults studied at the same time points and treated with MET, G/M, or liraglutide plus metformin (L+M) or given placebo (PLAC); and  3 ) 88 adults studied at baseline and after 12 and 24 months of LB or MET. Fasting glucagon, glucagon suppression by glucose, and acute glucagon response (AGR) to arginine were assessed during hyperglycemic clamps. Glucagon suppression was also measured during oral glucose tolerance tests (OGTTs).
RESULTS


No change in fasting glucagon, steady-state glucagon, or AGR was seen at 12 months following treatment with MET or G/M (in youth and adults) or PLAC (in adults). In contrast, L+M reduced these measures at 12 months (all  P  ≤ 0.005), which was maintained 3 months after treatment withdrawal (all  P  < 0.01). LB in adults also reduced fasting glucagon, steady-state glucagon, and AGR at 12 and 24 months ( P  < 0.05 for all, except AGR at 12 months [ P  = 0.098]). Similarly, glucagon suppression during OGTTs was greater with L+M and LB. Linear models demonstrated that treatment effects on glucagon with L+M and LB were largely associated with weight loss.
CONCLUSIONS


Glucagon concentrations were reduced by L+M and LB in adults with dysglycemia, an effect principally attributable to weight loss in both interventions.",2021,"In contrast, L+M reduced these measures at 12 months (all  P  ≤ 0.005), which was maintained 3 months after treatment withdrawal (all  P  < 0.01).","['G/M), and 3 months after treatment withdrawal;  2 ) 267 adults studied at the same time points and treated with', 'dysglycemic youth and adults in the Restoring Insulin Secretion (RISE', 'Dysglycemic Youth and Adults in the RISE Study', 'adults with dysglycemia', 'Glucagon was measured in three randomized, parallel, clinical studies:  1 ) 91 youth studied at baseline, after 12 months on']","['Medical and Surgical Interventions', 'medications and laparoscopic gastric band surgery (LB', 'PLAC', 'metformin alone (MET) or glargine followed by metformin', 'MET, G/M, or liraglutide plus metformin (L+M) or given placebo (PLAC']","['weight loss', 'α-cell function', 'fasting glucagon, steady-state glucagon, or AGR', 'Fasting glucagon, glucagon suppression by glucose, and acute glucagon response (AGR) to arginine', 'α-Cell Function', 'Glucagon suppression', 'glucagon suppression', 'fasting glucagon, steady-state glucagon, and AGR']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C1948041', 'cui_str': 'Surgical and medical procedures'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1960832', 'cui_str': 'Partitioning of stomach using band'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0048838', 'cui_str': ""5'-palmitoyl cytarabine""}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}]",267.0,0.0399599,"In contrast, L+M reduced these measures at 12 months (all  P  ≤ 0.005), which was maintained 3 months after treatment withdrawal (all  P  < 0.01).","[{'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'VA Puget Sound Health Care System, Seattle, WA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'Biostatistics Center, The George Washington University, Rockville, MD rise@bsc.gwu.edu.'}, {'ForeName': 'Silva A', 'Initials': 'SA', 'LastName': 'Arslanian', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barengolts', 'Affiliation': 'Jesse Brown VA Medical Center, Chicago, IL.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ehrmann', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Santica', 'Initials': 'S', 'LastName': 'Marcovina', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': 'University of Colorado Denver, Aurora, CO.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'VA Puget Sound Health Care System, Seattle, WA.'}, {'ForeName': 'Anny H', 'Initials': 'AH', 'LastName': 'Xiang', 'Affiliation': 'Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc21-0461']
681,34143258,Low-volume reduced bowel preparation regimen for CT colonography: a randomized noninferiority trial.,"PURPOSE


To determine whether the quality of a low-volume reduced bowel preparation (LV-RBP) for CT Colonography (CTC) is noninferior to full-volume reduced bowel preparation (FV-RBP) regimen.
METHODS


In this randomized controlled trial, consecutive participants referred for CTC were randomly assigned to receive LV-RBP (52.5 g of PMF104 in 500 mL of water) or FV-RBP (105 g of PMF104 in 1000 mL of water). Images were independently reviewed by five blinded readers who rated the quality of bowel preparation from 0 (best score) to 3 (worst score). The primary outcome was the noninferiority of LV-RBP to FV-RBP in the proportion of colonic segments scored 0 for cleansing quality, with noninferiority margin of 10%. Volume of residual fluids, colonic distension, lesions and polyps detection rates and patient tolerability were secondary outcomes.
RESULTS


From March 2019 to January 2020, 110 participants (mean age 65 years ± 14 [standard deviation]; 74 women) were allocated to LV-RBP (n = 55) or FV-RBP (n = 55) arms. There were 92% segment scored 0 in colon cleansing quality in LV-RBP and 94% in FV-RBP for prone scans, and 94% vs 92% for supine scans. Risk difference was - 2.1 (95% CI -5.9 to 1.7) and 1.5 (95% CI -2.4 to 5.4) for prone and supine positions, respectively. Residual fluids and colonic distension were also noninferior in LV-RBP. LV-RBP was associated with a lower number of evacuations during preparation (7 ± 5 vs 10 ± 6, p = 0.002).
CONCLUSION


The LV-RBP for CTC demonstrated noninferior quality of colon cleansing with improved gastrointestinal tolerability compared to FV-RBP regimen.",2021,"LV-RBP was associated with a lower number of evacuations during preparation (7 ± 5 vs 10 ± 6, p = 0.002).
","['consecutive participants referred for CTC', 'From March 2019 to January 2020, 110 participants (mean age 65\xa0years\u2009±\u200914 [standard deviation]; 74 women']","['CT Colonography (CTC', 'CT colonography', 'PMF104 in 500\xa0mL of water) or FV-RBP', 'LV-RBP', 'FV-RBP']","['Volume of residual fluids, colonic distension, lesions and polyps detection rates and patient tolerability', 'Residual fluids and colonic distension', 'Risk difference', 'LV-RBP', 'noninferiority of LV-RBP to FV-RBP in the proportion of colonic segments scored 0 for cleansing quality', 'colon cleansing quality', 'gastrointestinal tolerability']","[{'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0935912', 'cui_str': 'Computed Tomographic Colonography'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0935912', 'cui_str': 'Computed Tomographic Colonography'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.139382,"LV-RBP was associated with a lower number of evacuations during preparation (7 ± 5 vs 10 ± 6, p = 0.002).
","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Bellini', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome - I.C.O.T. Hospital, Via Franco Faggiana, 1668, 04100, Latina, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Panvini', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome - I.C.O.T. Hospital, Via Franco Faggiana, 1668, 04100, Latina, Italy. npanvini88@gmail.com.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Vicini', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome - I.C.O.T. Hospital, Via Franco Faggiana, 1668, 04100, Latina, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rengo', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome - I.C.O.T. Hospital, Via Franco Faggiana, 1668, 04100, Latina, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Lucchesi', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome - I.C.O.T. Hospital, Via Franco Faggiana, 1668, 04100, Latina, Italy.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Caruso', 'Affiliation': ""Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Carbone', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome - I.C.O.T. Hospital, Via Franco Faggiana, 1668, 04100, Latina, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Laghi', 'Affiliation': ""Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}]",Abdominal radiology (New York),['10.1007/s00261-021-03176-8']
682,34118783,Clinical predictors of poor 30-day headache outcomes after an emergency department visit for acute post-traumatic headache.,"PURPOSE


We investigated clinical risk factors that predict poor 30-day headache outcomes among patients evaluated in the emergency department (ED) for post-traumatic headache (PTH).
METHODS


This was an analysis of data from a randomized, placebo-controlled study of IV metoclopramide + diphenhydramine for acute PTH. Patients were enrolled during an ED visit and received telephone follow-up with a structured questionnaire 30 days later. The primary outcome was frequency of headaches 30 days after ED discharge. We used multivariable logistic regression models to determine which clinical variables were associated with frequent headaches at 30 days.
RESULTS


In total, 160 patients were enrolled in the study. 134 (84%) patients completed the 30-day questionnaire and were included in the analysis, including 90 females and 44 males. 30 patients (22%, 95% CI = 0.16 to 0.30) reported frequent headaches at 30-day follow-up. In the multivariable analysis, female sex (OR = 4.03, 95% CI = 1.23±13.13), patients who blamed themselves for their injury (OR = 0.13, 95% CI = 0.04±0.45), and patients who were unsure if they sustained loss of consciousness during the traumatic incident (OR = 5.63, 95% CI = 1.89±16.78) were found to be associated with poor 30-day outcomes. Medication received in the ED and age were not associated.
CONCLUSIONS


More than 1 out of five patients treated in the ED for acute PTH experienced frequent headaches 30 days later. Women and patients who were uncertain as to whether they had experienced loss of consciousness were at increased risk of frequent PTH. Blaming oneself for the head trauma was associated with less frequent PTH.",2021,"In the multivariable analysis, female sex (OR = 4.03, 95% CI = 1.23±13.13), patients who blamed themselves for their injury (OR = 0.13, 95% CI = 0.04±0.45), and patients who were unsure if they sustained loss of consciousness during the traumatic incident (OR = 5.63, 95% CI = 1.89±16.78) were found to be associated with poor 30-day outcomes.","['acute PTH', '134 (84%) patients completed the 30-day questionnaire and were included in the analysis, including 90 females and 44 males', '160 patients were enrolled in the study', 'acute post-traumatic headache', 'patients evaluated in the emergency department (ED) for post-traumatic headache (PTH']","['metoclopramide + diphenhydramine', 'placebo', 'telephone follow-up with a structured questionnaire 30 days later']","['loss of consciousness', 'frequent headaches', 'frequency of headaches 30 days after ED discharge', '30-day headache outcomes']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0032816', 'cui_str': 'Posttraumatic headache'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0948396', 'cui_str': 'Frequent headache'}, {'cui': 'C0857361', 'cui_str': 'Headache occurring'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",160.0,0.166198,"In the multivariable analysis, female sex (OR = 4.03, 95% CI = 1.23±13.13), patients who blamed themselves for their injury (OR = 0.13, 95% CI = 0.04±0.45), and patients who were unsure if they sustained loss of consciousness during the traumatic incident (OR = 5.63, 95% CI = 1.89±16.78) were found to be associated with poor 30-day outcomes.","[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Wang', 'Affiliation': 'Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY 10461, USA. Electronic address: andrewraywang@gmail.com.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Calandra', 'Affiliation': 'A.T. Still University School of Osteopathic Medicine in Arizona, 5850 E. Still Circle, Mesa, AZ 85206, USA.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Friedman', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, 111 East 210th Street, Bronx, NY 10467, USA. Electronic address: befriedm@montefiore.org.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.05.075']
683,34131733,Central Insulin Modulates Dopamine Signaling in the Human Striatum.,"OBJECTIVE


Activity in the dopaminergic pathways of the brain is highly sensitive to body weight and metabolic states. Animal studies show that dopamine neurons are important targets for the metabolic hormone insulin with abolished effects in the insulin-resistant state, leading to increases in body weight and food intake. In humans, the influence of central acting insulin on dopamine and effects of their interplay are still elusive.
RESEARCH DESIGN AND METHODS


We investigated whether central administered insulin influences dopaminergic activity in striatal regions and whole-brain neural activity. Using a positron emission tomography (PET)/magnetic resonance imaging (MRI) hybrid scanner, we simultaneously performed [11C]-raclopride-PET and resting-state functional MRI in 10 healthy normal-weight men after application of intranasal insulin or placebo on 2 separate days in a randomized, placebo-controlled, blinded, crossover trial.
RESULTS


In response to central insulin compared with placebo administration, we observed greater [11C]-raclopride binding potential in the bilateral ventral and dorsal striatum. This suggests an insulin-induced reduction in synaptic dopamine levels. Resting-state striatal activity was lower 15 and 30 minutes after nasal insulin compared with placebo. Functional connectivity of the mesocorticolimbic circuitry associated with differences in dopamine levels: individuals with a stronger insulin-induced effect on dopamine levels showed a stronger increase in functional connectivity 45 minutes after intranasal insulin.
CONCLUSIONS


This study indicates that central insulin modulates dopaminergic tone in the striatum, which may affect regional brain activity and connectivity. Our results deepen the understanding of the insulin-dopamine interaction and the complex network that underlies the regulation of whole-body metabolism.",2021,Resting-state striatal activity was lower 15 and 30 min after nasal insulin compared to placebo.,['10 healthy normal weight men after application of'],"['PET/MRI hybrid scanner, we simultaneously performed [ 11C]-raclopride-PET and resting state fMRI', 'placebo', 'intranasal insulin or placebo']","['body weight and food intake', 'Resting-state striatal activity']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C3641326', 'cui_str': 'Positron emission tomography-magnetic resonance imaging'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0072953', 'cui_str': 'Raclopride'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",10.0,0.141833,Resting-state striatal activity was lower 15 and 30 min after nasal insulin compared to placebo.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kullmann', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Department of Nuclear Medicine and Clinical Molecular Imaging, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Benjamin Assad', 'Initials': 'BA', 'LastName': 'Jaghutriz', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Gassenmaier', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, Oncology, Clinical Immunology and Rheumatology, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Bender', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Häring', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Germany.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Reischl', 'Affiliation': 'Werner Siemens Imaging Center, Department of Preclinical Imaging and Radiopharmacy, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Preissl', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'la Fougère', 'Affiliation': 'Department of Nuclear Medicine and Clinical Molecular Imaging, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fritsche', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Reimold', 'Affiliation': 'Department of Nuclear Medicine and Clinical Molecular Imaging, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heni', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab410']
684,34118367,The impact of gender on researchers' assessment: A randomized controlled trial.,"OBJECTIVES


This randomized controlled trial aimed to test whether women or men would be preferred with identical curriculum vitae (CV); and the impact of the career stage in the evaluators' choice.
STUDY DESIGN AND SETTING


A simulated post-doctoral process was carried forward to be assessed for judgment. Level 1 and 2 Brazilian fellow researchers in the field of Dentistry were invited to act as external reviewers in a post-doctoral process and were randomly assigned to receive a CV from a woman or a man. They were required to rate the CV from 0 to 10 in scientific contribution, leadership potential, ability to work in groups, and international experience.
RESULTS


For all categories of CVs evaluated, CVs from men received higher scores compared to the CVs from women. Robust variance Poisson regressions demonstrated that men were more likely to receive higher scores in all categories, despite applicants' career stage. For example, CVs from men were nearly three quarters more likely to be seen as having leadership potential than equivalent CVs from women.
CONCLUSION


Gender bias is powerfully prevalent in academia in the dentistry field, despite researchers' career stage. Actions like implicit bias training must be urgently implemented to avoid (or at least decrease) that more women are harmed.",2021,"Robust variance Poisson regressions demonstrated that men were more likely to receive higher scores in all categories, despite applicants' career stage.",['women or men'],['identical curriculum vitae (CV'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0592257', 'cui_str': 'Vita-E'}]",[],,0.307949,"Robust variance Poisson regressions demonstrated that men were more likely to receive higher scores in all categories, despite applicants' career stage.","[{'ForeName': 'Marina Christ', 'Initials': 'MC', 'LastName': 'Franco', 'Affiliation': 'Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital - General Campus, 501 Smyth Rd, Ottawa, Canada; Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil. Electronic address: mchrist@ohri.ca.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Helal', 'Affiliation': 'Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital - General Campus, 501 Smyth Rd, Ottawa, Canada; Universidade do Extremo Sul Catarinense, 1105 Universitária Avenue, Criciúma, Santa Catarina, Brazil.'}, {'ForeName': 'Maximiliano Sérgio', 'Initials': 'MS', 'LastName': 'Cenci', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moher', 'Affiliation': 'Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital - General Campus, 501 Smyth Rd, Ottawa, Canada.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2021.05.026']
685,34143803,Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial.,"INTRODUCTION


The complex relationship between intimate partner violence and psychological distress warrants an integrated intervention approach. In this study we examined the relevance, acceptability, and feasibility of evaluating a multi-sectoral integrated violence- and mental health-focused intervention (Nguvu).
METHODS


We enrolled 311 Congolese refugee women from Nyarugusu refugee camp in Tanzania with past-year intimate partner violence and elevated psychological distress in a feasibility cluster randomized trial. Women were recruited from local women's groups that were randomized to the Nguvu intervention or usual care. Participants from women's groups randomized to Nguvu received 8 weekly sessions delivered by lay refugee incentive workers. Psychological distress, intimate partner violence, other wellbeing, and process indicators were assessed at baseline and 9-weeks post-enrollment to evaluate relevance, acceptability, and feasibility of implementing and evaluating Nguvu in refugee contexts.
RESULTS


We found that Nguvu was relevant to the needs of refugee women affected by intimate partner violence. We found reductions in some indicators of psychological distress, but did not identify sizeable changes in partner violence over time. Overall, we found that Nguvu was acceptable and feasible. However, challenges to the research protocol included baseline imbalances between study conditions, differential intervention completion related to intimate partner violence histories, differences between Nguvu groups and facilitators, and some indication that Nguvu may be less beneficial for participants with more severe intimate partner violence profiles.
CONCLUSIONS


We found evidence supporting the relevance of Nguvu to refugee women affected by partner violence and psychological distress and moderate evidence supporting the acceptability and feasibility of evaluating and implementing this intervention in a complex refugee setting. A definitive cluster randomized trial requires further adaptations for recruitment and eligibility screening, randomization, and retention.
TRIAL REGISTRATION


ISRCTN65771265, June 27, 2016.",2021,We found evidence supporting the relevance of Nguvu to refugee women affected by partner violence and psychological distress and moderate evidence supporting the acceptability and feasibility of evaluating and implementing this intervention in a complex refugee setting.,"['311 Congolese refugee women from Nyarugusu refugee camp in Tanzania with past-year intimate partner violence and elevated psychological distress in a feasibility cluster randomized trial', 'participants with more severe intimate partner violence profiles', ""Women were recruited from local women's groups"", 'psychological distress and intimate partner violence in refugees']","['multi-sectoral integrated violence- and mental health-focused intervention (Nguvu', 'integrated intervention', 'Nguvu intervention or usual care', 'Nguvu received 8 weekly sessions delivered by lay refugee incentive workers']","['partner violence', 'relevance, acceptability, and feasibility of implementing and evaluating Nguvu in refugee contexts', 'psychological distress', 'Psychological distress, intimate partner violence, other wellbeing, and process indicators']","[{'cui': 'C0337830', 'cui_str': 'Congolese'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242477', 'cui_str': 'Refugee Camps'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242543', 'cui_str': ""Women's Groups""}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439741', 'cui_str': 'Sectoral'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",311.0,0.0603717,We found evidence supporting the relevance of Nguvu to refugee women affected by partner violence and psychological distress and moderate evidence supporting the acceptability and feasibility of evaluating and implementing this intervention in a complex refugee setting.,"[{'ForeName': 'M Claire', 'Initials': 'MC', 'LastName': 'Greene', 'Affiliation': 'Program on Forced Migration and Health, Columbia University Mailman School of Public Health, New York, New York, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Likindikoki', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rees', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Bonz', 'Affiliation': 'HIAS, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department Psychiatry, Public Mental Health and Population Sciences, Stanford University, Palo Alto, California, United States of America.'}, {'ForeName': 'Lusia', 'Initials': 'L', 'LastName': 'Misinzo', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Tasiana', 'Initials': 'T', 'LastName': 'Njau', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Shangwe', 'Initials': 'S', 'LastName': 'Kiluwa', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Turner', 'Affiliation': 'Department of Community-Public Health, Johns Hopkins School of Nursing, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ventevogel', 'Affiliation': 'Public Health Section, United Nations High Commissioner for Refugees, Geneva, Switzerland.'}, {'ForeName': 'Jessie K K', 'Initials': 'JKK', 'LastName': 'Mbwambo', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Wietse A', 'Initials': 'WA', 'LastName': 'Tol', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.'}]",PloS one,['10.1371/journal.pone.0252982']
686,33252552,Dual Mobility Cup: Does It Improve Patient's Satisfaction After Total Hip Arthroplasty? A Prospective Comparative Randomized Study.,"INTRODUCTION


Despite the great success of total hip arthroplasty (THA), many patients were fairly dissatisfied after surgery. Therefore, patient-reported outcome measures have become of an utmost importance in assessing the results after joint replacement. This study was conducted to compare the postoperative patient-reported satisfactions after implantation of two commonly used THA designs.
METHODS


Of 180 patients, who initially fulfilled the study selection criteria and received cementless THA, 165 patients were finally eligible and enrolled in this prospective comparative randomized study. All surgeries were carried out between 2010 and 2018. Two groups of homogenous demographic and clinical data were present. Group A patients (n = 80) were treated by large head THA, whereas group B (n = 85) received dual mobility cup designs. The Western Ontario McMaster Universities Osteoarthritis Index and visual analog scale were used for clinical evaluation. The degree of improvement that the patient expected and hoped before undergoing their surgeries was estimated using the score of the new knee society. The self-administered patient satisfaction scale was used to record the levels of patient satisfaction after surgery, and their values were statistically analyzed in relation to preoperative expectation scores (ie, score of the new knee society) and different clinical and sociodemographic variables.
RESULTS


After a mean follow-up of 79 ± 4.13 months (range 24 to 96 months), both groups recorded a significant improvement (P < 0.05) in Western Ontario McMaster Universities Osteoarthritis Index and visual analogue scale scores. Patients of group B were significantly more satisfied (P < 0.05) than those of group A up to the first postoperative year. Certain studied variables were linked to superior satisfaction results among group B at the last follow-up.
CONCLUSIONS


Dual mobility THA provides better patient satisfaction than their standard large head alternatives specifically among elderly patients, socially unsupported individuals, farmers, heavy manual workers, and those with high levels of expectations.
CLINICAL TRIAL REGISTRATION


Clinical Trials.gov identifier: NCT04333316.",2021,Patients of group B were significantly more satisfied (P < 0.05) than those of group A up to the first postoperative year.,"['Of 180 patients, who initially fulfilled the study selection criteria and received', '165 patients were finally eligible and enrolled']","['cementless THA', 'Dual mobility THA', 'total hip arthroplasty (THA', 'Dual Mobility Cup', 'dual mobility cup designs']","['Western Ontario McMaster Universities Osteoarthritis Index and visual analogue scale scores', 'patient satisfaction', 'Western Ontario McMaster Universities Osteoarthritis Index and visual analog scale']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C4319555', 'cui_str': '165'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",80.0,0.0265381,Patients of group B were significantly more satisfied (P < 0.05) than those of group A up to the first postoperative year.,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Samy', 'Affiliation': 'From the Orthopedic Department, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ashraf Atef', 'Initials': 'AA', 'LastName': 'Mahmoud', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'El-Tantawy', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-20-00882']
687,34125899,Impact of Vitamin D and Calcium Supplementation on Bone Mineral Density and Bone Metabolism Among Thai Adolescents With Perinatally Acquired Human Immunodeficiency Virus (HIV) Infection: A Randomized Clinical Trial.,"BACKGROUND


To evaluate the impact of vitamin D and calcium supplementation (VitD/Ca) on lumbar spine bone mineral density (LSBMD) and bone metabolism among Thai adolescents with perinatally acquired HIV (PHIVA).
METHODS


A multicenter, randomized, active-control, open-labeled trial was conducted. PHIVA (aged 10-20 years) who were on stable cART were enrolled. Baseline LSBMD status was defined as low (z-score ≤ -2) and normal (> -2). Eligible PHIVA were randomly assigned to receive standard-dose (400 IU/1200 mg/day) or high-dose (400 IU/1200 mg/day plus ergocalciferol 20 000 IU/week) VitD/Ca supplementation for 48 weeks (ratio 1:1, stratified by baseline LSBMD). Study outcomes were changes in LSBMD, LSBMD z-scores, and bone metabolism-related biomarkers (25-hydroxyvitamin D [25(OH)D], intact parathyroid hormone [iPTH], C-terminal telopeptide [CTX], procollagen type I amino-terminal propeptide [PINP]) from baseline to week 48.
RESULTS


Among 200 enrolled PHIVA, median age was 16 (IQR:14-18) years; 61% were on NNRTI-based cART. Median 25(OH)D level was 25.5 (IQR: 20.8-33.0) ng/mL. After 48-week VitD/Ca supplementation, LSBMD significantly increased in both treatment groups (high-dose: median: +0.07 [IQR: +0.04 to +0.11] g/cm2; P < .001; standard-dose: +0.09 [+0.03 to +0.13] g/cm2; P < .001). Notably, the change in LSBMD z-scores was significantly greater in high-dose versus standard-dose groups (median: +0.4 [IQR: -0.1 to +0.9] vs +0.1 [-0.4 to +0.7]; P = .02). Levels of 25(OH)D increased, whereas iPTH, CTX, and PINP declined significantly in both groups (P < .05), but no between-group differences were demonstrated.
CONCLUSIONS


Over 48-week VitD/Ca supplementation, significant increases in LSBMD, and significant decreases in bone metabolism-related markers were observed among our Thai PHIVA in both treatment groups. The improvement in LSBMD z-score was more enhanced with high-dose VitD/Ca supplementation than standard-dose. High-dose VitD/Ca supplementation might be considered to promote bone health in this population.
CLINICAL TRIALS REGISTRATION


NCT02426840.",2021,"The levels of 25OHD increased, whereas iPTH, CTX, and PINP declined significantly in both groups(P<0.05); but no between-group differences were demonstrated.
","['200 enrolled PHIVA, a median age was 16', 'PHIVA(aged10-20years) who were on stable cART were enrolled', 'Thai adolescents with perinatally acquired HIV(PHIVA', 'Thai adolescents with perinatally acquired HIV infection']","['vitamin D and calcium supplementation', 'vitamin D and calcium supplementation(VitD/Ca', 'Ca (400IU/1,200mg daily), or high-dose VitD/Ca supplementation (400IU/1,200mg daily plus ergocalciferol', 'High-dose VitD/Ca supplementation', 'Ca supplementation']","['LSBMD', 'Baseline LSBMD status', 'median 25OHD level', 'LSBMD z-score', 'bone mineral density and bone metabolism', 'lumbar spine bone mineral density(LSBMD', 'levels of 25OHD increased, whereas iPTH, CTX, and PINP', 'bone metabolism-related markers', 'LSBMD z-scores', 'changes in LSBMD, LSBMD z-scores, and bone metabolism-related biomarkers (25-hydoxyvitamin D[25OHD], intact parathyroid hormone[iPTH], C-terminal telopeptide[CTX], procollagen type I amino-terminal propeptide[PINP']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0179636', 'cui_str': 'Cart'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}]","[{'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0047008', 'cui_str': ""3,4-O-isopropylidene-3,3',4,5'-tetrahydroxystilbene""}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0041457', 'cui_str': 'Type I Procollagen'}]",200.0,0.278814,"The levels of 25OHD increased, whereas iPTH, CTX, and PINP declined significantly in both groups(P<0.05); but no between-group differences were demonstrated.
","[{'ForeName': 'Tavitiya', 'Initials': 'T', 'LastName': 'Sudjaritruk', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Torsak', 'Initials': 'T', 'LastName': 'Bunupuradah', 'Affiliation': 'The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), The Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Aurpibul', 'Affiliation': 'Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Suparat', 'Initials': 'S', 'LastName': 'Kanjanavanit', 'Affiliation': 'Nakornping Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Tawalchaya', 'Initials': 'T', 'LastName': 'Chotecharoentanan', 'Affiliation': 'Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Natthanidnan', 'Initials': 'N', 'LastName': 'Sricharoen', 'Affiliation': 'Clinical and Molecular Epidemiology of Emerging and Re-emerging Infectious Diseases Research Cluster, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Pradthana', 'Initials': 'P', 'LastName': 'Ounchanum', 'Affiliation': 'Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand.'}, {'ForeName': 'Piyarat', 'Initials': 'P', 'LastName': 'Suntarattiwong', 'Affiliation': 'Queen Sirikit National Institute of Child Health, Bangkok, Thailand.'}, {'ForeName': 'Krittaporn', 'Initials': 'K', 'LastName': 'Pornpaisalsakul', 'Affiliation': 'Centre of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Centre of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab547']
688,34129365,Impact of Insulin Treatment on the Effect of Eplerenone: Insights From the EMPHASIS-HF Trial.,"BACKGROUND


Patients with heart failure with reduced ejection fraction (HFrEF) and insulin-treated diabetes have a high risk of cardiovascular complications. Mineralocorticoid receptor antagonists may mitigate this risk. We aim to explore the effect of eplerenone on cardiovascular outcomes and all-cause mortality in HFrEF patients with diabetes, including those treated with insulin in the EMPHASIS-HF trial (Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms).
METHODS


The primary outcome was the composite of heart failure hospitalization or cardiovascular death. Cox models with treatment-by-diabetes subgroup interaction terms were used.
RESULTS


The median follow-up was 21 (10-33) months. Of the 2737 patients included, 623 (23%) had non-insulin-treated diabetes, 236 (9%) had insulin-treated diabetes and 1878 did not have diabetes. Patients with insulin-treated diabetes were younger, more often women, with higher body mass index, waist circumference, more frequent ischemic heart failure cause, impaired kidney function, and longer diabetes duration. Compared with patients without diabetes, those with insulin-treated diabetes had a 2-fold higher risk of having a primary outcome event. The hazard ratio (95% CI) for the effect of eplerenone, compared with placebo, on the primary outcome was 0.31 (0.19-0.50) in insulin-treated diabetes, 0.69 (0.50-0.93) in non-insulin-treated diabetes, and 0.72 (0.58-0.88) in patients without diabetes; interaction  P =0.007. The annualized number needed-to-treat-to-benefit with regards to the primary outcome was 3 (95% CI, 3-4) in patients with insulin-treated diabetes, 16 (13-19) in patients with diabetes not receiving insulin, and 26 (24-28) in patients without diabetes.
CONCLUSIONS


Patients with insulin-treated diabetes experienced a greater benefit from eplerenone than those with diabetes not treated with insulin and people without diabetes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00232180.",2021,"Patients with insulin-treated diabetes were younger, more often women, with higher body mass index, waist circumference, more frequent ischemic heart failure cause, impaired kidney function, and longer diabetes duration.","['Patients with insulin-treated diabetes', 'Patients with heart failure with reduced ejection fraction (HFrEF) and insulin-treated diabetes', 'HFrEF patients with diabetes, including those treated with insulin in the EMPHASIS-HF trial (Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms', '2737 patients included, 623 (23%) had non-insulin-treated diabetes, 236 (9%) had insulin-treated diabetes and 1878 did not have diabetes']","['Eplerenone', 'Insulin', 'placebo', 'eplerenone']","['cardiovascular outcomes', 'composite of heart failure hospitalization or cardiovascular death', 'hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0436343', 'cui_str': 'Symptom mild'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",2737.0,0.239201,"Patients with insulin-treated diabetes were younger, more often women, with higher body mass index, waist circumference, more frequent ischemic heart failure cause, impaired kidney function, and longer diabetes duration.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations Cliniques, - Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France (J.P.F., Z.L., P.R., F.Z.).""}, {'ForeName': 'Zohra', 'Initials': 'Z', 'LastName': 'Lamiral', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations Cliniques, - Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France (J.P.F., Z.L., P.R., F.Z.).""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.).'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.).'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, the Netherlands (D.J.v.V.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vincent', 'Affiliation': 'Pfizer, New York (J.V.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations Cliniques, - Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France (J.P.F., Z.L., P.R., F.Z.).""}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Biostatistics, London School of Hygiene and Tropical Medicine, London, United Kingdom (S.J.P.).'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Division of Cardiology, University of Michigan, Ann Arbor (B.P.).'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations Cliniques, - Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France (J.P.F., Z.L., P.R., F.Z.).""}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.120.008075']
689,34140144,Dose-intensified Versus Conventional-dose Salvage Radiotherapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: The SAKK 09/10 Randomized Phase 3 Trial.,"BACKGROUND


Salvage radiotherapy (SRT) is utilized for biochemical progression of prostate cancer after radical prostatectomy (RP).
OBJECTIVE


To report the outcomes of the SAKK 09/10 trial comparing conventional and dose-intensified SRT.
DESIGN, SETTING, AND PARTICIPANTS


SAKK 09/10 was a randomized, multicenter, phase 3 trial that recruited men with biochemical progression after RP.
INTERVENTION


Patients were randomly assigned to conventional-dose (64 Gy) or dose-intensified SRT (70 Gy) to the prostate bed without hormonal therapy.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was freedom from biochemical progression (FFBP). Secondary endpoints included clinical progression-free survival (PFS), time to hormonal treatment, overall survival (OS), acute and late toxicity (Common Terminology Criteria for Adverse Events v4.0), and quality of life (QoL).
RESULTS AND LIMITATIONS


Between February 2011 and April 2014, 350 patients were randomly assigned to 64 Gy (n = 175) or 70 Gy (n = 175). Median prostate-specific antigen at randomization was 0.3 ng/ml. After median follow-up of 6.2 yr, the median FFBP was 8.2 yr in the 64 Gy arm and 7.6 in the 70 Gy arm (log-rank p = 0.4), with a hazard ratio of 1.14 (95% confidence interval 0.82-1.60). The 6-year FFBP rates were 62% and 61%, respectively. No significant differences in clinical PFS, time to hormonal treatment, or OS were observed. Late grade 2 and 3 genitourinary toxicity was observed in 35 (21%) and 13 (7.9%) patients in the 64 Gy arm, and 46 (26%) and seven (4%) in the 70 Gy arm, respectively (p = 0.8). Late grade 2 and 3 gastrointestinal toxicity was observed in 12 (7.3%) and seven patients (4.2%) in the 64 Gy arm, and 35 (20%) and four (2.3%) in the 70 Gy arm, respectively (p = 0.009). There were no significant differences in QoL.
CONCLUSIONS


Conventional-dose SRT to the prostate bed is sufficient in patients with early biochemical progression of prostate cancer after RP.
PATIENT SUMMARY


The optimal radiation therapy dose for patients who have increased tumor markers after surgery for prostate cancer is unclear. We found that administering a higher dose only increased the gastrointestinal side effects without providing any benefits to the patient. This clinical trial is registered on ClinicalTrials.gov as NCT01272050.",2021,"Late grade 2 and 3 gastrointestinal toxicity was observed in 12 (7.3%) and seven patients (4.2%) in the 64 Gy arm, and 35 (20%) and four (2.3%) in the 70 Gy arm, respectively (p = 0.009).","['SAKK 09/10 was a randomized, multicenter, phase 3 trial that recruited men with biochemical progression after RP', 'prostate cancer after radical prostatectomy (RP', 'Biochemically Recurrent Prostate Cancer', 'patients who have increased tumor markers after surgery for prostate cancer', 'patients with early biochemical progression of prostate cancer after RP', 'Between February 2011 and April 2014, 350 patients']","['Dose-intensified Versus Conventional-dose Salvage Radiotherapy', 'conventional and dose-intensified SRT', 'conventional-dose (64\u2009Gy) or dose-intensified SRT (70\u2009Gy) to the prostate bed without hormonal therapy', 'Salvage radiotherapy (SRT']","['Median prostate-specific antigen', '6-year FFBP rates', 'clinical progression-free survival (PFS), time to hormonal treatment, overall survival (OS), acute and late toxicity (Common Terminology Criteria for Adverse Events v4.0), and quality of life (QoL', 'Late grade 2 and 3 gastrointestinal toxicity', 'gastrointestinal side effects', 'clinical PFS, time to hormonal treatment, or OS', 'freedom from biochemical progression (FFBP', 'Late grade 2 and 3 genitourinary toxicity', 'median FFBP']","[{'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4759295', 'cui_str': 'Non-metastatic prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1739135', 'cui_str': 'Progression of prostate cancer'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517735', 'cui_str': '350'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}]",350.0,0.334169,"Late grade 2 and 3 gastrointestinal toxicity was observed in 12 (7.3%) and seven patients (4.2%) in the 64 Gy arm, and 35 (20%) and four (2.3%) in the 70 Gy arm, respectively (p = 0.009).","[{'ForeName': 'Pirus', 'Initials': 'P', 'LastName': 'Ghadjar', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern, Switzerland. Electronic address: pirus.ghadjar@charite.de.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hayoz', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Bernhard', 'Affiliation': 'IBCSG Coordinating Center, Bern, Switzerland; Department of Medical Oncology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Zwahlen', 'Affiliation': 'Department of Radiation Oncology, Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hölscher', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Gut', 'Affiliation': 'Department of Radiation Oncology, Kantonsspital Luzern, Luzern, Switzerland.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Polat', 'Affiliation': 'Department of Radiation Oncology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.'}, {'ForeName': 'Arndt-Christian', 'Initials': 'AC', 'LastName': 'Müller', 'Affiliation': 'Department of Radiation Oncology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Plasswilm', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern, Switzerland; Department of Radiation Oncology, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Papachristofilou', 'Affiliation': 'Department of Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Schär', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Sumila', 'Affiliation': 'Department of Radiation Oncology, Hirslanden Hospital Group, Zürich, Switzerland.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Zaugg', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern, Switzerland; Department of Radiation Oncology, Stadtspital Triemli, Zürich, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Guckenberger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Ost', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Reuter', 'Affiliation': 'Department of Radiation Oncology, Kantonsspital Münsterlingen, Switzerland.'}, {'ForeName': 'Davide G', 'Initials': 'DG', 'LastName': 'Bosetti', 'Affiliation': 'Department of Radiation Oncology, Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.'}, {'ForeName': 'Kaouthar', 'Initials': 'K', 'LastName': 'Khanfir', 'Affiliation': 'Department of Radiation Oncology, Hôpital Valais, Sion, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gomez', 'Affiliation': 'Department of Radiation Oncology, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wust', 'Affiliation': 'Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'George N', 'Initials': 'GN', 'LastName': 'Thalmann', 'Affiliation': 'Department of Urology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Aebersold', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2021.05.033']
690,34143883,An Open-label Phase I/IIa Clinical Trial of 11β-HSD1 Inhibitor for Cushing's Syndrome and Autonomous Cortisol Secretion.,"CONTEXT


11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) inhibitors demonstrate antimetabolic and antisarcopenic effects in Cushing's syndrome (CS) and autonomous cortisol secretion (ACS) patients.
OBJECTIVE


To confirm the efficacy and safety of S-707106 (11β-HSD1 inhibitor) administered to CS and ACS patients.
DESIGN


A 24-week single-center, open-label, single-arm, dose-escalation, investigator-initiated clinical trial on a database.
SETTING


Kyushu University Hospital, Kurume University Hospital, and related facilities.
PATIENTS


Sixteen patients with inoperable or recurrent CS and ACS, with mildly impaired glucose tolerance.
INTERVENTION


Oral administration of 200 mg S-707106 after dinner, daily, for 24 weeks. In patients with insufficient improvement in oral glucose tolerance test results at 12 weeks, an escalated dose of S-707106 (200 mg twice daily) was administered for the residual 12 weeks.
MAIN OUTCOME MEASURES


The rate of participants responding to glucose tolerance impairment, defined as those showing a 25% reduction in the area under the curve (AUC) of plasma glucose during the 75-g oral glucose tolerance test at 24 weeks.
RESULTS


S-707106 administration could not achieve the primary endpoint of this clinical trial (>20% of responsive participants). AUC glucose decreased by -7.1% [SD, 14.8 (90% CI -14.8 to -1.0), P = 0.033] and -2.7% [14.5 (-10.2 to 3.4), P = 0.18] at 12 and 24 weeks, respectively. S-707106 administration decreased AUC glucose significantly in participants with a high body mass index. Body fat percentage decreased by -2.5% [1.7 (-3.3 to -1.8), P < 0.001] and body muscle percentage increased by 2.4% [1.6 (1.7 to 3.1), P < 0.001].
CONCLUSIONS


S-707106 is an effective insulin sensitizer and antisarcopenic and antiobesity medication for these patients.",2021,"AUC glucose decreased by -7.1% (SD, 14.8 [90% CI: -14.8- -1.0], P=0.033) and -2.7% (14.5 [-10.2-3.4], P=0.18) at 12 and 24 weeks, respectively.","['participants with a high body mass index', 'Kyushu University Hospital, Kurume University Hospital, and related facilities', 'Sixteen patients with inoperable or recurrent CS and ACS, with mildly impaired glucose tolerance']","['200-mg S-707106', '11β-HSD1 inhibitor', 'S-707106', 'S-707106 (11β-HSD1 inhibitor']","['oral glucose tolerance test', 'area under the curve (AUC) of plasma glucose', 'body muscle percentage', 'AUC glucose', 'Body fat percentage', 'rate of participants responding to glucose tolerance impairment']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0454747', 'cui_str': 'Kyushu'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0010481', 'cui_str': ""Cushing's syndrome""}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",16.0,0.0756018,"AUC glucose decreased by -7.1% (SD, 14.8 [90% CI: -14.8- -1.0], P=0.033) and -2.7% (14.5 [-10.2-3.4], P=0.18) at 12 and 24 weeks, respectively.","[{'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Oda', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka-city, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka-city, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Uchiyama', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka-city, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka-city, Japan.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Hasuzawa', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka-city, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Nagayama', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Kurume University School of Medicine, Kurume-city, Japan.'}, {'ForeName': 'Lixiang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka-city, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Nagata', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka-city, Japan.'}, {'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka-city, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kishimoto', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka-city, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Todaka', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka-city, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka-city, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakanishi', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka-city, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nomura', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka-city, Japan.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab450']
691,34145206,Reducing Hospital Visit Rates in Hospice Patients Using Telemedicine.,"The purpose of this project was to examine the impact of accessibility to a provider via telemedicine on emergency department visit rates in adults, 35 years and older, on home hospice and palliative care. Utilizing a quasi-experimental design, 44 adults 35 years and older were educated on Doxy.me telemedicine usage as an intervention. Measures included gender, diagnosis, age, the reason for contact, and outcome (intervention group only); the number of emergency department visits, the number of 911 calls, and the number of discharges/transfers (control and intervention) in the 8 weeks after the evidence-based telemedicine intervention. Statistical analyses were performed to examine the number of emergency department visits and 911 calls preintervention and postintervention among all participants. A total of eight teletechnology calls were documented from a patient or patient caregiver. Among the intervention group, the number of emergency department visits and the number of 911 calls decreased from 12 (54.5%) to one (4.5%) postintervention. Paired-samples t tests show there were statistically significant differences in the number of emergency department visits and 911 calls between the two points in time. In conclusion, a telemedicine hospice care application may benefit a palliative and hospice organization by enhancing patient clinical outcomes and decreasing emergency department visit rates.",2021,Paired-samples t tests show there were statistically significant differences in the number of emergency department visits and 911 calls between the two points in time.,"['44 adults 35 years and older were educated on Doxy.me telemedicine usage as an intervention', 'emergency department visit rates in adults, 35 years and older, on home hospice and palliative care', 'Hospice Patients Using Telemedicine']",['provider via telemedicine'],"['Hospital Visit Rates', 'number of emergency department visits, the number of 911 calls, and the number of discharges/transfers (control and intervention', 'number of emergency department visits and the number of 911 calls', 'number of emergency department visits']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0652822,Paired-samples t tests show there were statistically significant differences in the number of emergency department visits and 911 calls between the two points in time.,"[{'ForeName': 'Clara Michelle', 'Initials': 'CM', 'LastName': 'Teter', 'Affiliation': 'Author Affiliations: Powder Springs, GA (Dr Teter); and School of Nursing, Troy University, AL (Drs Whitted and Vardaman).'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Whitted', 'Affiliation': ''}, {'ForeName': 'Shellye A', 'Initials': 'SA', 'LastName': 'Vardaman', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000769']
692,34120122,Comparison Between Short Text Messages and Phone Calls to Reduce No-Show Rates in Outpatient Medical Appointments: A Randomized Trial.,"The objective of this study was to evaluate the impact of telephone calls and short text messages (SMS) on no-show rates regarding scheduled appointments with a general practitioner. In a prospective, intervention-controlled, and randomized study, we divided 306 patients into 3 groups: telephone call, SMS, and no intervention. We compared no-show rates, as well as variables that influenced it. The lowest percentage of no-show (9.5%) occurred in the telephone call group, while the SMS group presented at 21% and the no-intervention group at 22.8% (P = .025). Telephone calls proved to be a superior strategy to text messaging.",2021,"The lowest percentage of no-show (9.5%) occurred in the telephone call group, while the SMS group presented at 21% and the no-intervention group at 22.8% (P = .025).","['Outpatient Medical Appointments', '306 patients into 3 groups', 'scheduled appointments with a general practitioner']","['telephone calls and short text messages (SMS', 'telephone call, SMS, and no intervention']",[],"[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],306.0,0.0122973,"The lowest percentage of no-show (9.5%) occurred in the telephone call group, while the SMS group presented at 21% and the no-intervention group at 22.8% (P = .025).","[{'ForeName': 'Rogério Cortecioni', 'Initials': 'RC', 'LastName': 'Lance', 'Affiliation': ""Professional Master's Program in Health Organizations Management (Mr Lance), and Department of Internal Medicine (Dr Pazin-Filho), Faculty of Medicine, University of São Paulo, Ribeirão Preto, Sao Paulo, Brazil; and Department of Medicine, Federal University of São Carlos, Sao Carlos, Sao Paulo, Brazil (Dr Neves).""}, {'ForeName': 'Antônio', 'Initials': 'A', 'LastName': 'Pazin-Filho', 'Affiliation': ''}, {'ForeName': 'Fábio Fernandes', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': ''}]",The Journal of ambulatory care management,['10.1097/JAC.0000000000000388']
693,34126263,The Sunscreen for Kindergarteners (SKIN) Study trial protocol.,"BACKGROUND


Exposure to ultraviolet radiation (UVR) is the major modifiable risk factor for skin cancers. The majority of lifetime UVR exposure occurs before age 20, underscoring an important window for risk reduction. Incorporation of skills-based sunscreen education into school health curricula may foster the development of consistent and effective use of sunscreen among children and youth. We describe the study protocol for a first-of-its-kind study that examined the feasibility of bringing skills-based sunscreen education into kindergarten classrooms.
METHODS


Participants were 96 kindergarten students across four classrooms in a single elementary school. A single-blind open-label trial design was used to evaluate the feasibility of incorporating a song-based, video-guided intervention for independent application of sunscreen into the kindergarten curriculum. Students first completed a 10-day no-intervention baseline period, followed by a 10-day intervention period, and then a 10-day randomized follow-up period where students were randomly assigned to continue with the intervention or to revert to the no-intervention condition.
OUTCOMES


Feasibility metrics associated with study process, resources, management, scientific outcomes and safety were gathered. The primary outcome was pre-to-post intervention changes in student engagement in the sunscreen task. The secondary outcome was pre-to-post intervention changes in the proportion of exposed skin to which a student applies sunscreen. Teacher and student perceptions of intervention value and utility were also evaluated.
DISCUSSION


This is the study protocol for a clinical trial designed to determine the feasibility of implementing a skills-based sunscreen curriculum in kindergarten classrooms. Next steps include evaluation of the intervention for efficacy and effectiveness.
CLINICAL TRIAL REGISTRATION


NCT03752736.",2021,The secondary outcome was pre-to-post intervention changes in the proportion of exposed skin to which a student applies sunscreen.,"['Participants were 96 kindergarten students across four classrooms in a single elementary school', 'kindergarten classrooms', 'children and youth']","['bringing skills-based sunscreen education', 'ultraviolet radiation (UVR', 'skills-based sunscreen curriculum']","['pre-to-post intervention changes in student engagement in the sunscreen task', 'study process, resources, management, scientific outcomes and safety', 'pre-to-post intervention changes in the proportion of exposed skin to which a student applies sunscreen', 'efficacy and effectiveness']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0332302', 'cui_str': 'Brought on by'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0041625', 'cui_str': 'Ultraviolet radiation'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",96.0,0.0267249,The secondary outcome was pre-to-post intervention changes in the proportion of exposed skin to which a student applies sunscreen.,"[{'ForeName': 'Gun Ho', 'Initials': 'GH', 'LastName': 'Lee', 'Affiliation': 'Stanford University School of Medicine, Department of Dermatology, 450 Broadway Street, Pavilion C, 2nd Floor - MC5334, Redwood City, CA 94063, USA.'}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Bae', 'Affiliation': 'Stanford University School of Medicine, Department of Dermatology, 450 Broadway Street, Pavilion C, 2nd Floor - MC5334, Redwood City, CA 94063, USA.'}, {'ForeName': 'Leandra A', 'Initials': 'LA', 'LastName': 'Barnes', 'Affiliation': 'Stanford University School of Medicine, Department of Dermatology, 450 Broadway Street, Pavilion C, 2nd Floor - MC5334, Redwood City, CA 94063, USA.'}, {'ForeName': 'Marlyanne M', 'Initials': 'MM', 'LastName': 'Pol-Rodriguez', 'Affiliation': 'Stanford University School of Medicine, Department of Dermatology, 450 Broadway Street, Pavilion C, 2nd Floor - MC5334, Redwood City, CA 94063, USA.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Ransohoff', 'Affiliation': 'Palo Alto Medical Foundation, Dermatology Division, 795 El Camino Real, Palo Alto, CA 94301, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Nord', 'Affiliation': 'Stanford University School of Medicine, Department of Dermatology, 450 Broadway Street, Pavilion C, 2nd Floor - MC5334, Redwood City, CA 94063, USA; Veterans Affairs Palo Alto Health Care System, 3801 Miranda Avenue (151Y), Palo Alto, CA 94304, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Stanford University School of Medicine, Departments of Biomedical Data Science, Radiology and Health Research and Policy, Medical School Office Building (MSOB), 1265 Welch Road, X359, Stanford, CA 94305-5464, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Cannell', 'Affiliation': 'University of Texas Health Sciences Center, School of Public Health, Department of Epidemiology, Human Genetics & Environmental Sciences, 6011 Harry Hines BLVD, Suite V8 106F, Dallas, TX 75390, USA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Weitlauf', 'Affiliation': ""Veterans Affairs Palo Alto Health Care System, 3801 Miranda Avenue (151Y), Palo Alto, CA 94304, USA; Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 401 Quarry Road (Women's Wellness Division, 2(nd) Floor), Stanford, CA 94303, USA. Electronic address: wjulie1@stanford.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106480']
694,34132880,Effects of acute caffeine ingestion on futsal performance in sub-elite players.,"PURPOSE


To date, no previous investigation has studied the effect of acute caffeine ingestion on futsal performance during futsal-specific testing and during a simulated match. Therefore, the aim of this investigation was to establish the effects of acute caffeine intake on futsal-specific tests and match-play running performance in male futsal players.
METHODS


Sixteen high-performance futsal players participated in a randomized, crossover, placebo-controlled and double-blind experiment. Each player completed two identical trials after ingesting either caffeine (3 mg/kg) or a placebo (cellulose). The trials consisted of a battery of futsal-specific tests (countermovement jump, 20-m sprint test, and a futsal kicking velocity and accuracy test) followed by a simulated futsal match (2 halves of 7.5 min). During the match, players' running performance was assessed with local positioning system devices.
RESULTS


In comparison to the placebo, caffeine ingestion increased jump height by 2.8% (p = 0.048; ES = 0.29) and reduced the time to complete the 20-m sprint test by -2.2% (p = 0.044; ES = - 0.54). Additionally, acute caffeine intake improved the distance covered at above 14.4 km/h by 19.6% (p = 0.021; ES = 0.58), the number of body impacts by 8.1% (p = 0.040; ES = 0.27) and the number of accelerations/decelerations by 4.2% (p = 0.044; ES = 0.57) during the simulated futsal match. However, no differences were reported in ball velocity or shooting accuracy in the futsal kicking test. There were no differences in the prevalence of side effects reported in the hours after the ingestion of the treatments.
CONCLUSION


Three mg/kg of caffeine enhanced several physical variables associated with futsal such as jump and sprint performance, and improved high-speed running and accelerations/decelerations during a simulated futsal match. Caffeine supplementation with a moderate dose can be considered as an effective ergogenic aid for futsal performance with low prevalence of side effects.
TRIAL REGISTRATION


The study was registered in ClinicalTrials.gov with the following ID: NCT04852315. The study was retrospectively registered by 18 April 2020.",2021,"In comparison to the placebo, caffeine ingestion increased jump height by 2.8% (p = 0.048; ES = 0.29) and reduced the time to complete the 20-m sprint test by -2.2% (p = 0.044; ES = - 0.54).","['male futsal players', 'sub-elite players', 'Sixteen high-performance futsal players']","['acute caffeine intake', 'Caffeine supplementation', 'placebo (cellulose', 'acute caffeine ingestion', 'futsal-specific tests (countermovement jump, 20-m sprint test', 'caffeine', 'placebo', 'placebo, caffeine ingestion']","['futsal performance', 'high-speed running and accelerations/decelerations', 'acute caffeine intake improved the distance covered', 'number of body impacts', 'number of accelerations/decelerations', 'ball velocity or shooting accuracy', 'futsal-specific tests and match-play running performance', 'jump height', 'prevalence of side effects', 'time to complete the 20-m sprint test']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]","[{'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1444774', 'cui_str': 'Shooting sensation quality'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",16.0,0.186635,"In comparison to the placebo, caffeine ingestion increased jump height by 2.8% (p = 0.048; ES = 0.29) and reduced the time to complete the 20-m sprint test by -2.2% (p = 0.044; ES = - 0.54).","[{'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'López-Samanes', 'Affiliation': 'Exercise Physiology Group, School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Moreno-Pérez', 'Affiliation': 'Centre for Translational Research in Physiotherapy, Department of Pathology and Surgery, Universidad Miguel Hernández, San Juan, Spain.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Travassos', 'Affiliation': 'Research Centre in Sport Sciences, Health and Human Development (CIDESD), Department of Sport Sciences, University of Beira Interior, Covilhã, Portugal.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, C/ Camino del Molino S/N., 28943, Fuenlabrada, Spain. juan.delcoso@urjc.es.'}]",European journal of nutrition,['10.1007/s00394-021-02617-w']
695,34131886,ED50 of Propofol Combined with Nalbuphine on the Sedative Effect in Painless Hysteroscopy.,"INTRODUCTION


Nalbuphine has gradually become a commonly used clinical analgesic drug for painless hysteroscopy. The aim of our study was to identify the median effective dose (ED50) of propofol combined with nalbuphine for painless hysteroscopy.
METHODS


Sixty-one patients aged 18-60 years were recruited to undergo elective painless hysteroscopy. Patients were administered 0.1 μg/kg nalbuphine (group A) or 0.2 μg/kg nalbuphine (group B) intravenously 3 min before endoscopic placement. The Dixon sequential method was used with an initial intravenous propofol dose of 2 mg/kg, which varied by 0.5 mg per kilogram.
RESULTS


The ED50 of propofol was 1.729 mg/kg (95% confidence interval [CI] 1.526-1.856 mg/kg) in group A and 1.658 mg/kg (95% CI 1.359-1.799 mg/kg) in group B. The 95% effective dose (ED95) of propofol was 2.051 mg/kg (95% CI 1.899-3.331 mg/kg) in group A and 2.020 mg/kg (95% CI 1.849-3.832 mg/kg) in group B.
CONCLUSION


For safety and effective painless hysteroscopic, the ED50 values of propofol combined with nalbuphine were 1.729 mg/kg (0.1 mg/kg nalbuphine) and 1.658 mg/kg (0.2 mg/kg nalbuphine). The recommended dose of nalbuphine is therefore 0.1 mg/kg.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR2100042342 ( http://www.chictr.org.cn/edit.aspx?pid=66342&htm=4 ; registration date 19 Jan 2021).",2021,"The 95% effective dose (ED95) of propofol was 2.051 mg/kg (95% CI 1.899-3.331 mg/kg) in group A and 2.020 mg/kg (95% CI 1.849-3.832 mg/kg) in group B.
CONCLUSION


For safety and effective painless hysteroscopic, the ED50 values of propofol combined with nalbuphine were 1.729 mg/kg (0.1 mg/kg nalbuphine) and 1.658 mg/kg (0.2 mg/kg nalbuphine).","['Sixty-one patients aged 18-60\xa0years', 'Painless Hysteroscopy']","['nalbuphine', 'nalbuphine (group A) or 0.2\xa0μg/kg nalbuphine', 'propofol', 'Propofol Combined with Nalbuphine', 'propofol combined with nalbuphine', 'elective painless hysteroscopy', 'Nalbuphine']",['median effective dose (ED50'],"[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",61.0,0.156658,"The 95% effective dose (ED95) of propofol was 2.051 mg/kg (95% CI 1.899-3.331 mg/kg) in group A and 2.020 mg/kg (95% CI 1.849-3.832 mg/kg) in group B.
CONCLUSION


For safety and effective painless hysteroscopic, the ED50 values of propofol combined with nalbuphine were 1.729 mg/kg (0.1 mg/kg nalbuphine) and 1.658 mg/kg (0.2 mg/kg nalbuphine).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Weixiang', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Department of Gynaecology, First Affiliated Hospital of Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China. zww.0511@hotmail.com.'}, {'ForeName': 'Yuanhai', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China. liyuanhai-1@163.com.'}]",Pain and therapy,['10.1007/s40122-021-00280-x']
696,34133205,Clinical Efficacy of Reduced-Dose Gadobutrol Versus Standard-Dose Gadoterate for Contrast-Enhanced MRI of the CNS: An International Multicenter Prospective Crossover Trial (LEADER-75).,"BACKGROUND.  Gadobutrol and gadoterate are widely used macrocyclic gadolinium-based contrast agents. Given gadobutrol's higher T1 relaxivity, a reduced gadobutrol dose should achieve essentially equivalent diagnostic efficacy as a standard dose of gadoterate.  OBJECTIVE.  The purpose of our study was to show efficacy of a 25% reduced dose of gadobutrol is noninferior to 100% standard dose of gadoterate for contrast-enhanced MRI of the CNS.  METHODS.  In this international prospective multicenter open-label crossover trial (LEADER-75 [Lower Administered Dose With Higher Relaxivity: Gadovist vs Dotarem]), adult patients with known or suspected CNS pathology underwent contrast-enhanced brain MRI with standard-dose gadoterate (0.1 mmol/kg); if an enhancing lesion was identified, a second MRI with reduced-dose gadobutrol (0.075 mmol/kg) was performed within 15 days of the first MRI. Three radiologists independently reviewed images to score three primary efficacy measures: subjective lesion enhancement, lesion border delineation, lesion internal morphology. A noninferiority analysis used readers' mean scores of the primary efficacy measures. Noninferiority of reduced-dose gadobutrol to standard-dose gadoterate for primary efficacy measures was defined as the difference in score between reduced-dose gadobutrol images and unenhanced images achieving at least 80% of the difference in score between standard-dose gadoterate images and unenhanced images. A post hoc analysis was performed to directly compare contrast-enhanced images for equivalence. Secondary efficacy variables included the number of lesions detected, reader confidence, diagnostic performance for malignancy, and reader preference in side-by-side comparison.  RESULTS.  The efficacy analysis included 141 patients (78 men, 63 women; mean age, 58.5 ± 13.5 [SD] years). Improvement of reduced-dose gadobutrol over unenhanced images was noninferior to improvement of standard-dose gadoterate over unenhanced images using a 20% noninferiority margin for all three primary efficacy measures using mean readings ( p  ≤ .025). In the post hoc analysis, the mean reading for the three primary efficacy measures differed by less than 1% between reduced-dose gadobutrol and standard-dose gadoterate, supporting equivalence of all measures using a narrow ± 5% margin ( p  ≤ .025). The total number of lesions detected by mean reading was 301 for reduced-dose gadobutrol versus 291 for standard-dose gadoterate. Mean reader confidence was 3.3 ± 0.6 for reduced-dose gadobutrol versus 3.3 ± 0.6 for standard-dose gadoterate. Sensitivity (58.7%), specificity (91.8%), and accuracy (70.2%) for malignancy from majority reading were identical for reduced-dose gadobutrol and standard-dose gadoterate. Reader preference was not different (95% CI, -0.10 to 0.11).  CONCLUSION.  A 25% reduced dose of gadobutrol is noninferior to standard-dose gadoterate for contrast-enhanced brain MRI.  CLINICAL IMPACT.  Use of reduced-dose gadobutrol should be considered for brain MRI, particularly in patients undergoing multiple contrast-enhanced examinations.  TRIAL REGISTRATION.  ClinicalTrials.gov NCT03602339; EU Clinical Trials Register EudraCT 2018-00690-78.",2021,Improvement of rd-gadobutrol over unenhanced images was non-inferior to improvement of sd-gadoterate over unenhanced images using 20% non-inferiority margin for all three primary efficacy measures using mean readings (p≤.025).,"['patients undergoing multiple contrast-enhanced examinations', 'Contrast-Enhanced MRI of the CNS', 'adult patients with known or suspected CNS pathology underwent contrast-enhanced brain MRI with sd-gadoterate (0.1 mmol/kg', '141 patients (78 men, 63 women; mean age, 58.5±13.5 years']","['Reduced Dose Gadobutrol Versus Standard Dose Gadoterate', 'rd-gadobutrol', 'gadobutrol (rd-gadobutrol']","['Mean confidence', 'Reader preference', 'Sensitivity', 'number of lesions detected, reader confidence, diagnostic performance for malignancy, and reader preference in side-by-side comparison', ""efficacy measures (subjective lesion enhancement, lesion border delineation, lesion internal morphology); primary non-inferiority analysis used readers' mean scores"", 'Total lesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}, {'cui': 'C0060929', 'cui_str': ""gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate""}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439291', 'cui_str': 'mmol/kg'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0291216', 'cui_str': 'gadobutrol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0060929', 'cui_str': ""gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate""}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449791', 'cui_str': 'Number of lesions'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0740805,Improvement of rd-gadobutrol over unenhanced images was non-inferior to improvement of sd-gadoterate over unenhanced images using 20% non-inferiority margin for all three primary efficacy measures using mean readings (p≤.025).,"[{'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Liu', 'Affiliation': 'Departments of Radiology and Radiation Oncology, Division of Neuroradiology, Feinberg School of Medicine of Northwestern University, Northwestern Memorial Hospital, Chicago, IL.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rosenberg', 'Affiliation': 'Radiology, Bayer Pharmaceuticals, Whippany, NJ.'}, {'ForeName': 'Pollice', 'Initials': 'P', 'LastName': 'Saverio', 'Affiliation': 'Ospedale ""L. Bonomo,"" Andria, Italy.'}, {'ForeName': 'Young Cheol', 'Initials': 'YC', 'LastName': 'Weon', 'Affiliation': 'Department of Radiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.'}, {'ForeName': 'Soenke', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Department of Radiology and Neuroradiology, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'François-Daniel', 'Initials': 'FD', 'LastName': 'Ardellier', 'Affiliation': ""Service d'Imagerie 2, Hôpitaux Universitaires de Strasbourg-Hôpital de Hautepierre, Strasbourg, France.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Boeckenhoff', 'Affiliation': 'Statistics and Data Insights, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Endrikat', 'Affiliation': 'Radiology, Bayer AG, Müllerstrasse 178, Berlin D-13353, Germany.'}]",AJR. American journal of roentgenology,['10.2214/AJR.21.25924']
697,34147867,The 3 Minute Step Test is a validated field test to evaluate the functional exercise capacity in children aged 6 to 12.,"BACKGROUND


Field tests are useful to assess the functional exercise capacity. The 6minute walking test (6MWT) is the most common field test even if alternatives are needed. The main aim of the study was to verify if the 3minute step test (3MST) is a valid tool to measure the functional exercise capacity and can surrogate the 6MWT in healthy children from 6- to 12-years-old.
METHODS


This randomized cross-over trial recruited 30 healthy children from 6 to 12 years. One 6MWT and two 3MST (3MST 1  and 3MST 2 ) were performed randomly on 3 consecutive days. The variables were the distance (6MWT), the number of steps (3MST) and the cardiorespiratory parameters.
RESULTS


The distance walked during 6MWT was very strongly correlated to the number of steps during the 3MST (3MST 1 : rho=0.833; P<0.001 and 3MST 2 : rho=0.868; P<0.001). Heart rate (HR) was lower than the theoretical maximal HR at the end of both tests. The change in HR and perceived fatigue were significantly higher after the 3MST. A learning effect was observed in the 3MST (+8 steps; P<0.001).
CONCLUSIONS


The 3MST is validated and can be a surrogate for the 6MWT in healthy children population between 6 and 12 years old. A training test is required in these children.",2021,"A learning effect was observed in the 3MST (+8 steps; P<0.001).
","['healthy children population between 6 and 12 years old', 'children aged 6 to 12', 'healthy children from 6- to 12-years-old', '30 healthy children from 6 to 12 years']","['3MST (3MST', '3minute step test (3MST', '6minute walking test (6MWT', '3MST']","['distance (6MWT), the number of steps (3MST) and the cardiorespiratory parameters', 'Heart rate (HR', 'change in HR and perceived fatigue', 'distance walked during 6MWT', 'functional exercise capacity']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}]",30.0,0.0536757,"A learning effect was observed in the 3MST (+8 steps; P<0.001).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Iturain Barrón', 'Affiliation': 'Escoles Universitàries Gimbernat, EUI Gimbernat, Universitat Autònoma de Barcelona, Sant Cugat del Vallès (Barcelona), Spain. Electronic address: amaia.iturain@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Quintana Riera', 'Affiliation': 'Escoles Universitàries Gimbernat, EUI Gimbernat, Universitat Autònoma de Barcelona, Sant Cugat del Vallès (Barcelona), Spain. Electronic address: 11145sqr@comb.cat.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Escoles Universitàries Gimbernat, EUI Gimbernat, Universitat Autònoma de Barcelona, Sant Cugat del Vallès (Barcelona), Spain; Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, Université Catholique de Louvain, Brussels, Belgium; Service de Pneumologie, Cliniques universitaires Saint-Luc, Brussels, Belgium; Secteur de Kinésithérapie et Ergothérapie, Cliniques universitaires Saint-Luc, Brussels, Belgium. Electronic address: gregory.reychler@uclouvain.be.'}]",Respiratory medicine and research,['10.1016/j.resmer.2021.100833']
698,34147854,"Do you see what I see? The influence of self-objectification on appearance anxiety, intrinsic motivation, interoceptive awareness, and physical performance.","Self-objectification negatively impacts body image, mental health, and cognitive performance outcomes in women and has been correlated with poorer physical performance. The purpose of this study was to determine if trying on a swimsuit (versus a sweater) impacted state self-objectification, body shame, social physique anxiety, intrinsic motivation, bodily awareness, and physical performance in university women. Female undergraduate students (N = 52) were randomly assigned to try on either a swimsuit (objectification condition) or sweater (control condition) and complete measures of self-objectification, body shame, appearance anxiety, intrinsic motivation, and interoceptive awareness, and perform a series of balance tasks. Women in the swimsuit condition reported higher state self-objectification, body-related shame and appearance anxiety, and lower intrinsic motivation compared to women in the sweater condition. In addition, women in the swimsuit condition restricted body movements during a 1-legged stand balance task. Consistent with objectification theory, women may have made smaller physical movements in an attempt to hide or cover up the body. Findings could have implications for promoting positive experiences during physical activity for women, such as in sport, exercise or rehabilitation settings.",2021,"Women in the swimsuit condition reported higher state self-objectification, body-related shame and appearance anxiety, and lower intrinsic motivation compared to women in the sweater condition.","['Female undergraduate students (N = 52', 'university women']","['swimsuit (objectification condition) or sweater (control condition) and complete measures of self-objectification, body shame, appearance anxiety, intrinsic motivation, and interoceptive awareness, and perform a series of balance tasks']","['Self-objectification negatively impacts body image, mental health, and cognitive performance outcomes', 'state self-objectification, body shame, social physique anxiety, intrinsic motivation, bodily awareness, and physical performance', 'appearance anxiety, intrinsic motivation, interoceptive awareness, and physical performance', 'higher state self-objectification, body-related shame and appearance anxiety, and lower intrinsic motivation', 'body movements']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0542352', 'cui_str': 'Pullover'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0424611', 'cui_str': 'Physique type'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",52.0,0.00599974,"Women in the swimsuit condition reported higher state self-objectification, body-related shame and appearance anxiety, and lower intrinsic motivation compared to women in the sweater condition.","[{'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Dimas', 'Affiliation': 'Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Galway', 'Affiliation': 'Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Kimberley L', 'Initials': 'KL', 'LastName': 'Gammage', 'Affiliation': 'Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON L2S 3A1, Canada. Electronic address: kgammage@brocku.ca.'}]",Body image,['10.1016/j.bodyim.2021.05.010']
699,34152804,Randomized Trial of Two Induction Therapy Regimens for High-Risk Neuroblastoma: HR-NBL1.5 International Society of Pediatric Oncology European Neuroblastoma Group Study.,"PURPOSE


Induction therapy is a critical component of the therapy of high-risk neuroblastoma. We aimed to assess if the Memorial Sloan Kettering Cancer Center (MSKCC) N5 induction regimen (MSKCC-N5) would improve metastatic complete response (mCR) rate and 3-year event-free survival (EFS) compared with rapid COJEC (rCOJEC; cisplatin [C], vincristine [O], carboplatin [J], etoposide [E], and cyclophosphamide [C]).
PATIENTS AND METHODS


Patients (age 1-20 years) with stage 4 neuroblastoma or stage 4/4s aged < 1 year with  MYCN  amplification were eligible for random assignment to rCOJEC or MSKCC-N5. Random assignment was stratified according to national group and metastatic sites. Following induction, therapy comprised primary tumor resection, high-dose busulfan and melphalan, radiotherapy to the primary tumor site, and isotretinoin with ch14.18/CHO (dinutuximab beta) antibody with or without interleukin-2 immunotherapy. The primary end points were mCR rate and 3-year EFS.
RESULTS


A total of six hundred thirty patients were randomly assigned to receive rCOJEC (n = 313) or MSKCC-N5 (n = 317). Median age at diagnosis was 3.2 years (range, 1 month to 20 years), and 16 were younger than 1 year of age with  MYCN  amplification. mCR rate following rCOJEC induction (32%, 86/272 evaluable patients) was not significantly different from 35% (99/281) with MSKCC-N5 ( P  = .368), and 3-year EFS was 44% ± 3% for rCOJEC compared with 47% ± 3% for MSKCC-N5 ( P  = .527). Three-year overall survival was 60% ± 3% for rCOJEC compared with 65% ± 3% for MSKCC-N5 ( P  = .379). Toxic death rates with both regimens were 1%. However, nonhematologic CTC grade 3 and 4 toxicities were higher with MSKCC-N5: 68% (193/283) versus 48% (129/268) ( P  < .001); infection 35% versus 25% ( P  = .011); stomatitis 25% versus 3% ( P  < .001); nausea and vomiting 17% versus 7% ( P  < .001); and diarrhea 7% versus 3% ( P  = .011).
CONCLUSION


No difference in outcome was observed between rCOJEC and MSKCC-N5; however, acute toxicity was less with rCOJEC, and therefore rCOJEC is the preferred induction regimen for International Society of Pediatric Oncology European Neuroblastoma Group.",2021,"mCR rate following rCOJEC induction (32%, 86/272 evaluable patients) was not significantly different from 35% (99/281) with MSKCC-N5 ( P  = .368), and 3-year EFS was 44% ± 3% for rCOJEC compared with 47% ± 3% for MSKCC-N5 ( P  = .527).","['high-risk neuroblastoma', 'Patients (age 1-20 years) with stage 4 neuroblastoma or stage 4/4s aged < 1 year with  MYCN  amplification were eligible for random assignment to rCOJEC or MSKCC-N5', 'High-Risk Neuroblastoma', 'A total of six hundred thirty patients', 'Median age at diagnosis was 3.2 years (range, 1 month to 20 years), and 16 were younger than 1 year of age with  MYCN  amplification']","['busulfan and melphalan, radiotherapy', 'rapid COJEC (rCOJEC; cisplatin [C], vincristine [O], carboplatin [J], etoposide [E], and cyclophosphamide [C', 'MSKCC-N5', 'rCOJEC', 'Memorial Sloan Kettering Cancer Center (MSKCC) N5 induction regimen (MSKCC-N5']","['overall survival', 'nonhematologic CTC grade 3 and 4 toxicities', 'nausea and vomiting', 'Toxic death rates', '3-year EFS', 'diarrhea', 'acute toxicity', 'metastatic complete response (mCR) rate and 3-year event-free survival (EFS', 'mCR rate following rCOJEC induction', 'mCR rate and 3-year EFS']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0278694', 'cui_str': 'Metastatic neuroblastoma'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1137610', 'cui_str': 'MYCN protein, human'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1828181', 'cui_str': 'Age at diagnosis'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",630.0,0.197804,"mCR rate following rCOJEC induction (32%, 86/272 evaluable patients) was not significantly different from 35% (99/281) with MSKCC-N5 ( P  = .368), and 3-year EFS was 44% ± 3% for rCOJEC compared with 47% ± 3% for MSKCC-N5 ( P  = .527).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Garaventa', 'Affiliation': 'IRCCS Istituto Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Poetschger', 'Affiliation': ""Children's Cancer Research Institute, Vienna, Austria.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Valteau-Couanet', 'Affiliation': 'Gustave Roussy, Villejuif, Paris, France.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Luksch', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Castel', 'Affiliation': 'Pediatric Oncology Unit, Hospital Universitari I Politecnic La Fe, Valencia, Spain.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Elliott', 'Affiliation': 'Leeds Teaching Hospitals, NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Shifra', 'Initials': 'S', 'LastName': 'Ash', 'Affiliation': ""Ruth Rappaport Children's Hospital, Rambam Health Care Campus, Haifa, Israel.""}, {'ForeName': 'Godfrey C F', 'Initials': 'GCF', 'LastName': 'Chan', 'Affiliation': ""University of Hong Kong and Hong Kong Children's Hospital, Hong Kong SAR, China.""}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Laureys', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Beck-Popovic', 'Affiliation': 'University Hospital Lausanne, Switzerland.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Vettenranta', 'Affiliation': ""Children's Hospital, University of Helsinki, Helsinki, Finland.""}, {'ForeName': 'Walentyna', 'Initials': 'W', 'LastName': 'Balwierz', 'Affiliation': 'Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Schroeder', 'Affiliation': 'Department of Paediatrics, University Hospital of Aarhus, Denmark.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'Owens', 'Affiliation': 'University of Dublin, Ireland.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Cesen', 'Affiliation': 'Pediatric Clinic, Ljubljana, Slovenia.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Papadakis', 'Affiliation': ""Agia Sofia Children's Hospital, Athens, Greece.""}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Trahair', 'Affiliation': ""Sydney Children's Hospital, Randwick, Australia.""}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Schleiermacher', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, Vienna, Austria.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Sorrentino', 'Affiliation': 'IRCCS Istituto Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Andrew D J', 'Initials': 'ADJ', 'LastName': 'Pearson', 'Affiliation': 'Retired. Institute of Cancer Research and Royal Marsden Hospital, Sutton, United Kingdom.'}, {'ForeName': 'Ruth Lydia', 'Initials': 'RL', 'LastName': 'Ladenstein', 'Affiliation': ""Department of Paediatrics, St Anna Children's Hospital and Children's Cancer Research Institute, Medical University, Vienna, Austria.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.03144']
700,34158569,Open-label placebo treatment to improve relaxation training effects in healthy psychology students: a randomized controlled trial.,"Placebos, that are administered with deception, can reduce stress and increase relaxation. The present study investigated an open-label placebo (OLP) to improve the effects of Progressive Muscle Relaxation (PMR) training. A total of 160 psychology students were randomly assigned to a 14-day PMR course with or without daily OLP treatment. The placebo was administered along with an explanation of placebo effects and the verbal suggestion that the OLP activates the body's natural relaxation response. The relaxation instructions for home practice were delivered via a smartphone app, which was also used for the evaluation of the exercises. The participants of the OLP group completed more PMR exercises (M = 9.75) than the group without a placebo (M = 8.15). The two groups did not differ in reported exercise-related changes in relaxation level. On average, the OLP group rated the effects of the placebo as very low and was characterized by a higher drop-out rate compared to the group without OLP. Some participants experienced the OLP as negative. In conclusion, factors that influence the acceptance of OLP treatment require further investigation.",2021,The participants of the OLP group completed more PMR exercises (M = 9.75) than the group without a placebo (M = 8.15).,"['160 psychology students', 'healthy psychology students']","['Progressive Muscle Relaxation (PMR) training', '14-day PMR course with or without daily OLP treatment', 'placebo', 'open-label placebo (OLP', 'Open-label placebo', 'Placebos']","['relaxation level', 'stress and increase relaxation', 'relaxation training effects', 'PMR exercises']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",160.0,0.0287117,The participants of the OLP group completed more PMR exercises (M = 9.75) than the group without a placebo (M = 8.15).,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Department of Clinical Psychology, University of Graz, Universitätsplatz 2/DG, 8010, Graz, Austria. anne.schienle@uni-graz.at.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Unger', 'Affiliation': 'Department of Clinical Psychology, University of Graz, Universitätsplatz 2/DG, 8010, Graz, Austria.'}]",Scientific reports,['10.1038/s41598-021-92579-0']
701,34147014,"Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study.","AIM


The aim of the study was to assess patient preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in patients with HER2-positive early breast cancer in PHranceSCa (NCT03674112).
MATERIALS AND METHODS


Patients who completed neoadjuvant P + H + chemotherapy + surgery were randomised 1:1 to three intravenous (IV) P + H cycles followed by three cycles of PH FDC SC or vice versa (crossover) and then chose subcutaneous (SC) injection or IV infusion to continue up to 18 cycles (continuation). Assessments were via patient and healthcare professional (HCP) questionnaires.
RESULTS


One hundred and sixty patients were randomised (cut-off: 24 February 2020); 136 (85.0%, 95% confidence interval: 78.5-90.2%) preferred SC; 22 (13.8%) preferred IV; 2 (1.3%) had no preference. The main reasons for SC preference were reduced clinic time (n = 119) and comfort during administration (n = 73). One hundred and forty-one patients (88.1%) were very satisfied/satisfied with SC injection versus 108 (67.5%) with IV infusion; 86.9% chose PH FDC SC continuation. HCP perceptions of median patient treatment room time ranged from 33.0-50.0 min with SC and 130.0-300.0 min with IV. Most adverse events (AEs) were grade 1/2 (no 4/5s); serious AE rates were low. AE rates before and after switching were similar (cycles 1-3 IV → cycles 4-6 SC: 77.5% → 72.5%; cycles 1-3 SC → cycles 4-6 IV: 77.5% → 63.8%).
CONCLUSION


Most patients strongly preferred PH FDC SC over P + H IV. PH FDC SC was generally well tolerated, with no new safety signals (even when switching), and offers a quicker alternative to IV infusion.",2021,"PH FDC SC was generally well tolerated, with no new safety signals (even when switching), and offers a quicker alternative to IV infusion.","['Patients who completed neoadjuvant P\xa0+\xa0H\xa0+\xa0chemotherapy\xa0+ surgery', 'patients with HER2-positive early breast cancer (PHranceSCa', 'One hundred and sixty patients', 'patients with HER2-positive early breast cancer in PHranceSCa (NCT03674112']","['pertuzumab and trastuzumab', 'PH FDC SC', 'intravenous (IV) P\xa0+\xa0H cycles followed by three cycles of PH FDC SC or vice versa (crossover)\xa0and then chose subcutaneous (SC) injection or IV infusion', 'pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC']","['serious AE rates', 'healthcare professional (HCP) questionnaires', 'AE rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",160.0,0.137638,"PH FDC SC was generally well tolerated, with no new safety signals (even when switching), and offers a quicker alternative to IV infusion.","[{'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Baylor University Medical Center, Texas Oncology, US Oncology, 3410 Worth Street, Suite 400, Dallas, TX 75246, USA. Electronic address: Joyce.OShaughnessy@usoncology.com.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Sousa', 'Affiliation': 'Department of Medical Oncology, Portuguese Oncology Institute of Porto, Porto, Portugal. Electronic address: susanapalmadesousa@gmail.com.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Cruz', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario de Canarias, La Laguna, S/C Tenerife, Spain. Electronic address: jcruzjurado@gmail.com.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Fallowfield', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9RR, UK. Electronic address: l.j.fallowfield@sussex.ac.uk.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Auvinen', 'Affiliation': 'Cancer Center, Kuopio University Hospital, Kuopio, Finland. Electronic address: paivi.auvinen@kuh.fi.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Pulido', 'Affiliation': 'Hospital da Luz Lisboa, Avenida Lusíada, 100, 1500-650, Lisbon, Portugal. Electronic address: catarina.pulido@hospitaldaluz.pt.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cvetanovic', 'Affiliation': 'Department of Medical Oncology, Medical Faculty Nis and Clinical Centre Nis, Bul.dr Zorana Djindjica 48, 18000, Nis, Serbia. Electronic address: ana.stankovic@yahoo.com.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Wilks', 'Affiliation': 'Texas Oncology SA, Hematology/Medical Oncology, 2130 NE Loop 410 Suite 100, San Antonio, TX 78217, USA. Electronic address: sharon.wilks@usoncology.com.'}, {'ForeName': 'Leonor', 'Initials': 'L', 'LastName': 'Ribeiro', 'Affiliation': 'Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, 1649-028, Lisbon, Portugal. Electronic address: leonor.ribeiro@chln.min-saude.pt.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Burotto', 'Affiliation': 'Bradford Hill Clinical Research Center, Santiago, Chile. Electronic address: mauricioburotto@gmail.com.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Klingbiel', 'Affiliation': 'Pharma Development Biometrics, Biostatistics, F. Hoffmann-La Roche Ltd, Hochstrasse 16, CH-4053 Basel, Switzerland. Electronic address: dirk.klingbiel@roche.com.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Messeri', 'Affiliation': 'PDG Clinical Operations Oncology, F. Hoffmann-La Roche Ltd, Hochstrasse 16, CH-4053 Basel, Switzerland. Electronic address: dimitri.messeri@roche.com.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Alexandrou', 'Affiliation': 'Portfolio Clinical Safety, Product Development Safety, Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, UK. Electronic address: ari.alexandrou@roche.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Trask', 'Affiliation': 'Patient Centered Outcomes Research, Oncology, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. Electronic address: trask.peter@gene.com.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Fredriksson', 'Affiliation': 'Global Product Development/Medical Affairs Oncology, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland. Electronic address: judy.fredriksson@roche.com.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Machackova', 'Affiliation': 'Global Product Development/Medical Affairs Oncology, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland. Electronic address: zuzana.machackova@roche.com.'}, {'ForeName': 'Ljiljana', 'Initials': 'L', 'LastName': 'Stamatovic', 'Affiliation': 'Clinic for Medical Oncology, Institute for Oncology and Radiology of Serbia, Pasterova 14, 11000, Belgrade, Serbia. Electronic address: ljstamat@ncrc.ac.rs.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.03.047']
702,34151822,"Comparison of the effects of low level laser and insoles on pain, functioning, and muscle strength in subjects with stage 2 posterior tibial tendon dysfunction: A randomized study.","BACKGROUND


Low level laser therapy (LLLT) is known to be effective in tendinopathies. No study yet investigated the effect of LLLT on posterior tibial tendon dysfunction (PTTD) in comparison to orthotic treatment.
OBJECTIVE


The aim was to compare the effects of LLLT and insole application on pain, function and muscle strength in subjects with stage 2 PTTD.
METHODS


Fifty-two subjects with stage 2 PTTD were randomly assigned to the LLLT and insole groups. The foot pain, function and strength of invertor and evertor muscles of the subjects was evaluated before and after treatment, and after 9 months.
RESULTS


Significant improvement was observed in the foot function and pain (p< 0.05) in both groups after treatment, but in the 9-month follow-up, the insole group had better values. The increase in 180∘.sec-1 concentric invertor muscle strength was found significant after the treatment and in month-9 as compared to the initial values (p< 0.05).
CONCLUSIONS


Both treatments are effective in reducing treating foot pain, as well as improving the function in subjects with stage 2 PTTD. However, at the end of the 9-month follow-up, it was seen that insoles were more effective. Neither method had a clinically important effect on muscle strength.",2021,"RESULTS


Significant improvement was observed in the foot function and pain (p< 0.05) in both groups after treatment, but in the 9-month follow-up, the insole group had better values.","['subjects with stage 2 posterior tibial tendon dysfunction', 'subjects with stage 2 PTTD', 'Fifty-two subjects with stage 2 PTTD']","['LLLT', 'low level laser and insoles', 'Low level laser therapy (LLLT']","['180∘.sec-1 concentric invertor muscle strength', 'pain, function and muscle strength', 'pain, functioning, and muscle strength', 'foot pain, function and strength of invertor and evertor muscles', 'treating foot pain', 'posterior tibial tendon dysfunction (PTTD', 'muscle strength', 'foot function and pain']","[{'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C1136154', 'cui_str': 'Dysfunction of posterior tibial tendon'}, {'cui': 'C4319570', 'cui_str': '52'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C3873740', 'cui_str': 'Insole'}]","[{'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1136154', 'cui_str': 'Dysfunction of posterior tibial tendon'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]",52.0,0.0152339,"RESULTS


Significant improvement was observed in the foot function and pain (p< 0.05) in both groups after treatment, but in the 9-month follow-up, the insole group had better values.","[{'ForeName': 'Cansu', 'Initials': 'C', 'LastName': 'Koltak', 'Affiliation': ''}, {'ForeName': 'Yasin', 'Initials': 'Y', 'LastName': 'Yurt', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200199']
703,34156521,Ten-year clinical outcomes of polymer-free versus durable polymer new-generation drug-eluting stent in patients with coronary artery disease with and without diabetes mellitus : Results of the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol- and Zotarolimus-Eluting Stents (ISAR-TEST 5) trial.,"BACKGROUND


Very long-term outcomes according to diabetic status of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (DES) are scant. Both, the durable polymer zotarolimus-eluting stent (DP-ZES), the first DES to gain FDA-approval for specific use in patients with diabetes mellitus, and the polymer-free sirolimus- and probucol-eluting stent (PF-SES), with a unique design that enables effective drug release without the need of a polymer offer the potential to enhance clinical long-term outcomes especially in patients with diabetes mellitus.
METHODS


We investigate 10-year clinical outcomes of the prespecified subgroups of patients with and without diabetes mellitus, randomly assigned to treatment with PF-SES versus DP-ZES in the ISAR-TEST 5 trial. The primary endpoint of interest was major adverse cardiac events (MACE), defined as the composite of all-cause death, any myocardial infarction or any revascularization. Further endpoints of interest were cardiac death, myocardial infarction related to the target vessel and target lesion revascularization as well as the individual components of the primary composite endpoint and the incidence of definite or probable stent thrombosis at 10 years.
RESULTS


This analysis includes a total of 3002 patients randomly assigned to PF-SES (n = 2002) or DP-ZES (n = 1000). Prevalence of diabetes mellitus was high and comparable, 575 Patients (28.7%) in PF-SES group and 295 patients (29.5%) in DP-ZES group (P = 0.66). At 10 years 53.5% of patients with diabetes mellitus and 68.5% of patients without diabetes mellitus were alive. Regarding major adverse cardiac events, PF-SES as compared to DP-ZES showed comparable event rates in patients with diabetes mellitus (74.8% vs. 79.6%; hazard ratio 0.86; 95% CI 0.73-1.02; P = 0.08) and in patients without diabetes (PF-SES 62.5% vs. DP-ZES 62.2%; hazard ratio 0.99; 95% CI 0.88-1.11; P = 0.88).
CONCLUSION


At 10 years, both new-generation DES show comparable clinical outcome irrespective of diabetic status or polymer strategy. Event rates after PCI in patients with diabetes mellitus are considerable higher than in patients without diabetes mellitus and continue to accrue over time.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT00598533, Registered 10 January 2008, https://clinicaltrials.gov/ct2/show/NCT00598533?term=NCT00598533 Kaplan-Meier estimates of endpoints of interest for patients with vs. without diabetes mellitus treated with PF-SES vs. DP-ZES. Bar graphs: Kaplan-Meier estimates as percentages. PF-SES: polymer-free sirolimus-eluting stent; DP-ZES: durable polymer zotarolimus-eluting stent; DM: diabetes mellitus. Comparison of event rates of individual endpoints in patients with and without diabetes mellitus treated with PF-SES vs. DP-ZES all without statistically significant differences. Comparison of event rates of individual endpoints in overall patients with vs. without diabetes mellitus significantly different (P ≤ 0.01 for all comparisons).",2021,"Prevalence of diabetes mellitus was high and comparable, 575 Patients (28.7%) in PF-SES group and 295 patients (29.5%) in DP-ZES group (P = 0.66).","['patients with vs. without diabetes mellitus treated with', 'patients with coronary artery disease (CAD) undergoing', 'diabetes mellitus', 'patients with and without diabetes mellitus treated with', '3002 patients randomly assigned to', 'patients with coronary artery disease with and without diabetes mellitus ', 'patients with diabetes mellitus', 'patients with and without diabetes mellitus']","['PF-SES', 'polymer-free versus durable polymer new-generation drug-eluting stent', 'percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (DES', 'PF-SES vs. DP-ZES', 'durable polymer zotarolimus-eluting stent (DP-ZES', 'zotarolimus-eluting stent; DM', 'Intracoronary Stenting and Angiographic Results', 'Sirolimus- and Probucol- and Zotarolimus-Eluting Stents', 'DP-ZES', 'PF-SES versus DP-ZES', 'PF-SES: polymer-free sirolimus-eluting stent; DP-ZES']","['major adverse cardiac events (MACE), defined as the composite of all-cause death, any myocardial infarction or any revascularization', 'cardiac death, myocardial infarction related to the target vessel and target lesion revascularization', 'Prevalence of diabetes mellitus', 'incidence of definite or probable stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1700035', 'cui_str': 'Zotarolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0033215', 'cui_str': 'Probucol'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",3002.0,0.110792,"Prevalence of diabetes mellitus was high and comparable, 575 Patients (28.7%) in PF-SES group and 295 patients (29.5%) in DP-ZES group (P = 0.66).","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Lenz', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joner', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany.'}, {'ForeName': 'Erion', 'Initials': 'E', 'LastName': 'Xhepa', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Koppara', 'Affiliation': '1. medizinische Klinik, Klinikum Rechts der Isar, Technische Universität, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wiebe', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Coughlan', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany.'}, {'ForeName': 'Alp', 'Initials': 'A', 'LastName': 'Aytekin', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany.'}, {'ForeName': 'Tareq', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': '1. medizinische Klinik, Klinikum Rechts der Isar, Technische Universität, Munich, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kessler', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': '1. medizinische Klinik, Klinikum Rechts der Isar, Technische Universität, Munich, Germany.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'Deutsches Herzzentrum München, Klinik Für Herz- Und Kreislauferkrankungen, an der Technischen Universität München, Lazarettstrasse 36, 80636, Munich, Germany. sebastian.kufner@gmx.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-021-01854-7']
704,34156474,Systemic inflammation down-regulates glyoxalase-1 expression: an experimental study in healthy males.,"BACKGROUND


Hypoxia and inflammation are hallmarks of critical illness, related to multiple organ failure. A possible mechanism leading to multiple organ failure is hypoxia- or inflammation-induced down-regulation of the detoxifying glyoxalase system that clears dicarbonyl stress. The dicarbonyl methylglyoxal (MGO) is a highly reactive agent produced by metabolic pathways such as anaerobic glycolysis and gluconeogenesis. MGO leads to protein damage and ultimately multi-organ failure. Whether detoxification of MGO into D-lactate by glyoxalase functions appropriately under conditions of hypoxia and inflammation is largely unknown. We investigated the effect of inflammation and hypoxia on the MGO pathway in humans in vivo.
METHODS


After prehydration with glucose 2.5% solution, ten healthy males were exposed to hypoxia (arterial saturation 80-85%) for 3.5 h using an air-tight respiratory helmet, ten males to experimental endotoxemia (LPS 2 ng/kg i.v.), ten males to LPS+hypoxia and ten males to none of these interventions (control group). Serial blood samples were drawn, and glyoxalase-1 mRNA expression, MGO, methylglyoxal-derived hydroimidazolone-1 (MG-H1), D-lactate and L-lactate levels, were measured serially.
RESULTS


Glyoxalase-1 mRNA expression decreased in the LPS (β (95%CI); -0.87 (-1.24; -0.50) and the LPS+hypoxia groups; -0.78 (-1.07; -0.48) (P<0.001). MGO was equal between groups, whereas MG-H1 increased over time in the control group only (P=0.003). D-Lactate was increased in all four groups. L-Lactate was increased in all groups, except in the control group.
CONCLUSION


Systemic inflammation downregulates glyoxalase-1 mRNA expression in humans. This is a possible mechanism leading to cell damage and multi-organ failure in critical illness with potential for intervention.",2021,"L-lactate was increased in all groups, except in the control group.
","['ten healthy males', 'humans', 'healthy males', 'humans in vivo']",['Systemic inflammation downregulates glyoxalase-1 expression'],"['glyoxalase-1 mRNA expression, MGO, methylglyoxal-derived hydroimidazolone-1 (MG-H1), D-lactate and L-lactate levels', 'D-lactate', 'MGO', 'LPS (β (95%CI', 'L-lactate', 'MG-H1 increased over time', 'Glyoxalase-1 mRNA expression']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0022956', 'cui_str': 'Lactoylglutathione lyase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0022956', 'cui_str': 'Lactoylglutathione lyase'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034338', 'cui_str': 'Pyruvaldehyde'}, {'cui': 'C1174802', 'cui_str': 'hydroimidazolone'}, {'cui': 'C0522080', 'cui_str': 'D-lactate'}, {'cui': 'C1881354', 'cui_str': 'L-lactate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",10.0,0.0233999,"L-lactate was increased in all groups, except in the control group.
","[{'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'G H Driessen', 'Affiliation': 'Department of Intensive Care Medicine, Maastricht University Medical Center +, Maastricht, The Netherlands.'}, {'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'Kiers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'G Schalkwijk', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Center +, Maastricht, The Netherlands.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'L J M Scheijen', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Center +, Maastricht, The Netherlands.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Gerretsen', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'C G van de Poll', 'Affiliation': 'Department of Intensive Care Medicine, Maastricht University Medical Center +, Maastricht, The Netherlands.'}, {'ForeName': 'Iwan', 'Initials': 'I', 'LastName': 'C C van der Horst', 'Affiliation': 'Department of Intensive Care Medicine, Maastricht University Medical Center +, Maastricht, The Netherlands.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'C J J Bergmans', 'Affiliation': 'Department of Intensive Care Medicine, Maastricht University Medical Center +, Maastricht, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kox', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'C T van Bussel', 'Affiliation': 'Department of Intensive Care Medicine, Maastricht University Medical Center +, Maastricht, The Netherlands.'}]",Bioscience reports,['10.1042/BSR20210954']
705,34153248,Role of Superficial Cervical Plexus Nerve Block as an Adjuvant to Local Anesthesia in the Maxillofacial Surgical Practice.,"PURPOSE


Infiltration techniques are used as an adjuvant to regional anesthesia. In this study, we evaluated the efficacy of the superficial cervical plexus nerve block, as an alternative to local infiltration techniques; in the management of mandibular fractures and peri-mandibular space infections.
METHODS


A prospective randomized controlled trial was conducted on 24 patients having either mandibular fractures or peri-mandibular space infections; and were scheduled for surgery under regional anesthesia (eg, inferior alveolar nerve block, long buccal nerve block). The control group involved delivering a combination of regional anesthesia along with local infiltration. The experimental group received regional anesthesia with a superficial cervical plexus nerve block. The following parameters were studied: pain, onset and duration of anesthesia, time interval until first analgesic request, pulse rate and blood pressure [at different time intervals].
RESULTS


Intergroup comparison was done using unpaired t-test. Intragroup comparison was done using repeated measures ANOVA (for >2 observations), followed by a post hoc test. The superficial cervical plexus nerve block group showed highly statistically significant (P < .01) improvement in terms of intra-operative pain at 30 minutes, duration of anesthesia, intraoperative anesthetic requirement, time interval until first analgesic request and intraoperative diastolic blood pressure at 10 minutes.
CONCLUSION


It can be concluded that the combination of a regional anesthesia technique with a superficial cervical plexus nerve block is an alternative and safe technique for patients undergoing surgery for mandible fractures and perimandibular space infections, with clear advantages over local infiltration.",2021,"The superficial cervical plexus nerve block group showed highly statistically significant (P < .01) improvement in terms of intra-operative pain at 30 minutes, duration of anesthesia, intraoperative anesthetic requirement, time interval until first analgesic request and intraoperative diastolic blood pressure at 10 minutes.
","['24 patients having either mandibular fractures or peri-mandibular space infections; and were scheduled for surgery under regional anesthesia (eg, inferior alveolar nerve block, long buccal nerve block', 'patients undergoing surgery for mandible fractures and perimandibular space infections']","['Superficial Cervical Plexus Nerve Block', 'control group involved delivering a combination of regional anesthesia along with local infiltration', 'superficial cervical plexus nerve block', 'regional anesthesia with a superficial cervical plexus nerve block']","['intra-operative pain at 30 minutes, duration of anesthesia, intraoperative anesthetic requirement, time interval until first analgesic request and intraoperative diastolic blood pressure', 'pain, onset and duration of anesthesia, time interval until first analgesic request, pulse rate and blood pressure [at different time intervals']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0394798', 'cui_str': 'Local anesthetic long buccal nerve block'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0228825', 'cui_str': 'Superficial branch of cervical plexus'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0416254,"The superficial cervical plexus nerve block group showed highly statistically significant (P < .01) improvement in terms of intra-operative pain at 30 minutes, duration of anesthesia, intraoperative anesthetic requirement, time interval until first analgesic request and intraoperative diastolic blood pressure at 10 minutes.
","[{'ForeName': 'Prajwalit', 'Initials': 'P', 'LastName': 'Kende', 'Affiliation': 'Head of Department, Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Mumbai.'}, {'ForeName': 'Maroti', 'Initials': 'M', 'LastName': 'Wadewale', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Mumbai. Electronic address: dr.marotiwadewale59@gmail.com.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mathai', 'Affiliation': 'Ex-Assistant Professor, Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Mumbai.'}, {'ForeName': 'Jayant', 'Initials': 'J', 'LastName': 'Landge', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Mumbai.'}, {'ForeName': 'Harsh', 'Initials': 'H', 'LastName': 'Desai', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Mumbai.'}, {'ForeName': 'Vijayalaxmi', 'Initials': 'V', 'LastName': 'Nimma', 'Affiliation': 'Assistant professor, Department of Oral Medicine and Radiology, Government Dental College and Hospital, Mumbai.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2021.05.005']
706,34155332,"Efficacy and tolerability of baclofen in a U.S. community population with alcohol use disorder: a dose-response, randomized, controlled trial.","Identification of new medications for alcohol use disorder (AUD) is important for improving treatment options. Baclofen, a GABA B  agonist, has been identified as a potential pharmacotherapy for AUD. In a 16-week double-blind, randomized, placebo-controlled trial, we investigated 30 and 90 mg/day of baclofen compared to placebo and examined effects of dose, sex, and level of pretreatment drinking. One hundred and twenty participants with DSM-IV alcohol dependence (age 46.1 (sd = 10.1) years, 51.7% male) were randomized after exclusion for unstable medical/psychiatric illness and/or dependence on drugs other than nicotine. Seventy-three participants completed the trial. A main effect of baclofen was found [%HDD (F(2,112) = 4.16, p = 0.018, d = 0.51 95%CI (0.06-0.95), 13.6 fewer HDD) and %ABST (F(2,112) = 3.68, p = 0.028, d = 0.49 95%CI (0.04-0.93), 12.9 more abstinent days)] and was driven by the 90 mg/day dose. A sex × dose interaction effect was present for both %HDD (F(2,110) = 5.48, p = 0.005) and %ABST (F(2,110) = 3.19, p = 0.045). Men showed a marginally positive effect for 90 mg/day compared to PBO (%HDD t(110) = 1.88, p = 0.063, d = 0.36 95%CI (-0.09-0.80), 15.8 fewer HDD days; %ABST t(110) = 1.68 (p = 0.096, d = 0.32 95%CI (-0.12-0.76), 15.7 more ABST)) with no effect for 30 mg/day. Women showed a positive effect for 30 mg/day (%HDD, t(110) = 3.19, p = 0.002, d = 0.61 95%CI (0.16-1.05), 26.3 fewer HDD days; %ABST t(110) = 2.73, p = 0.007, d = 0.52 95%CI (0.07-0.96), 25.4 more ABST days) with marginal effects for 90 mg/day on %ABST (p = 0.06) with drop-outs/dose reduction from sedative side-effects of 59% in women at 90 mg/day compared to 5% for men. These findings support the hypothesis that baclofen has efficacy in AUD and suggest that dose and sex be further explored as potential moderators of baclofen response and tolerability.",2021,"A main effect of baclofen was found [%HDD (F(2,112) = 4.16, p = 0.018, d = 0.51 95%CI (0.06-0.95), 13.6 fewer HDD) and %ABST (F(2,112) = 3.68,","['One hundred and twenty participants with DSM-IV alcohol dependence (age 46.1 (sd\u2009=\u200910.1) years, 51.7% male', 'Seventy-three participants completed the trial', 'U.S. community population with alcohol use disorder']","['nicotine', 'baclofen', 'placebo']",['Efficacy and tolerability'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",120.0,0.160211,"A main effect of baclofen was found [%HDD (F(2,112) = 4.16, p = 0.018, d = 0.51 95%CI (0.06-0.95), 13.6 fewer HDD) and %ABST (F(2,112) = 3.68,","[{'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Garbutt', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. jc_garbutt@med.unc.edu.'}, {'ForeName': 'Alexei B', 'Initials': 'AB', 'LastName': 'Kampov-Polevoy', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Cort', 'Initials': 'C', 'LastName': 'Pedersen', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Stansbury', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Jordan', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Willing', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gallop', 'Affiliation': 'Department of Mathematics, Applied Statistics Program, West Chester University, West Chester, PA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01055-w']
707,34165792,Effects of Cough Suppression Therapy on Voice Disorder Severity.,"OBJECTIVES//HYPOTHESIS


To determine changes in voice severity when treating chronic cough refractory to medical treatment with cough suppression therapy (CST) in patients with chronic cough and voice complaints. Chronic cough has been reported to be refractory to medical treatment and frequently co-occurs with voice disorders. The possible effects of CST on self-assessed changes in chronic cough and voice disorders have not been demonstrated.
STUDY DESIGN


Retrospective analysis of the effects of cough suppression therapy (CST) on self-assessed changes in chronic cough and voice disorder severity in patients with both chronic cough and voice disorders.
METHODS


Forty-three adult patients with the primary complaint of chronic refractory cough underwent pre- and post-treatment diagnostic examinations, completed pre- and post-treatment Voice Handicap Index-10 (VHI-10) and Cough Severity Index assessments, and were treated by a licensed speech-language pathologist using CST. Twenty-seven subjects were assigned to the cough (C) group and 16 to the cough-voice (CV) group based on the severity of their VHI-10 scores.
RESULTS


Post-test analysis showed significant improvement in cough severity for both groups and significant improvement in voice severity for the CV group. The VHI-10 scores for the C group did not change significantly. The median number of treatment sessions was 3, with a range of 1-13 sessions. Correlation between changes in severity and number of treatment sessions was not found to be significant at the tested level.
CONCLUSIONS


CST represents a unifying approach for treatment of patients with CRC and comorbid voice disorders. CST offered cross-over effects to the voice when subjects were treated for their primary complaint of chronic cough. This treatment of the primary complaint improves function in systems that share a common pathway.
LEVEL OF EVIDENCE


4 Laryngoscope, 131:2747-2751, 2021.",2021,"RESULTS


Post-test analysis showed significant improvement in cough severity for both groups and significant improvement in voice severity for the CV group.","['patients with chronic cough and voice complaints', 'Twenty-seven subjects were assigned to the cough (C) group and 16 to the cough-voice (CV) group based on the severity of their VHI-10 scores', 'patients with both chronic cough and voice disorders', 'patients with CRC and comorbid voice disorders', 'Forty-three adult patients with the primary complaint of chronic refractory cough underwent pre- and post-treatment diagnostic examinations, completed pre- and post-treatment Voice Handicap Index-10 (VHI-10) and Cough Severity Index assessments, and were treated by a licensed speech-language pathologist using CST']","['cough suppression therapy (CST', 'CST', 'Cough Suppression Therapy']","['Voice Disorder Severity', 'chronic cough and voice disorder severity', 'voice severity', 'median number of treatment sessions', 'cough severity', 'VHI-10 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}, {'cui': 'C0522046', 'cui_str': 'Cough suppression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0522046', 'cui_str': 'Cough suppression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0042940', 'cui_str': 'Voice Disorders'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",43.0,0.0456799,"RESULTS


Post-test analysis showed significant improvement in cough severity for both groups and significant improvement in voice severity for the CV group.","[{'ForeName': 'Donn', 'Initials': 'D', 'LastName': 'LaTour', 'Affiliation': 'School of Medicine, Loma Linda University, Loma Linda, California, U.S.A.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Crawley', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Loma Linda University Health, Loma Linda, California, U.S.A.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Krishna', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Loma Linda University Health, Loma Linda, California, U.S.A.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hahn', 'Affiliation': 'School of Medicine, Loma Linda University, Loma Linda, California, U.S.A.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Murry', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Loma Linda University Health, Loma Linda, California, U.S.A.'}]",The Laryngoscope,['10.1002/lary.29705']
708,34149004,Pharmacogenetic study in gastric cancer patients treated with adjuvant fluorouracil/leucovorin or epirubicin/cisplatin/fluorouracil before and after chemoradiation on CALGB 80101 (Alliance).,"There is a lack of pharmacogenetic predictors of outcome in gastric cancer patients. The aim of this study was to assess previously identified candidate genes associated with 5-fluorouracil (5-FU), cisplatin, or epirubicin toxicity or response in a cohort of resected gastric cancer patients treated on CALGB (Alliance) 80101. Gastric or gastroesophageal cancer patients randomized to adjuvant 5-FU/leucovorin or epirubicin/cisplatin/5-FU before and after 5-FU chemoradiation were genotyped for single nucleotide polymorphisms (SNPs) in GSTP1 (rs1695), ERCC1 (rs11615 and rs3212986), XRCC1 (rs25487), UGT2B7 (rs7439366) and the 28 base-pair tandem repeats in TYMS (rs34743033). Logistic regression and log rank tests were used to assess the association between each SNP and incidence of grade 3/4 neutropenia and leukopenia, overall (OS) and progression-free survival (PFS), respectively. Toxicity endpoint analyses were adjusted for the treatment arm, while OS and PFS were also adjusted for performance status, sex, age, lymph node involvement, and primary tumor site and size. Of 281 subjects with successful genotyping results and available clinical (toxicity and efficacy) data, 166 self-reported non-Hispanic White patients were included in the final analysis. There was a lack of evidence of an association among any SNPs tested with grade 3/4 neutropenia and leukopenia or OS and PFS. Age, lymph node involvement, and primary tumor size were significantly associated with OS and PFS. This study failed to confirm results of previous gastric cancer pharmacogenetic studies.",2021,There was a lack of evidence of an association among any SNPs tested with grade 3/4 neutropenia and leukopenia or OS and PFS.,"['gastric cancer patients', '281 subjects with successful genotyping results and available clinical (toxicity and efficacy) data, 166 self-reported non-Hispanic White patients were included in the final analysis', 'resected gastric cancer patients treated on CALGB (Alliance) 80101', 'Gastric or gastroesophageal cancer patients', 'gastric cancer patients treated with']","['adjuvant fluorouracil/leucovorin or epirubicin/cisplatin/fluorouracil', 'adjuvant 5-FU/leucovorin or epirubicin/cisplatin/5-FU', '5-fluorouracil (5-FU), cisplatin, or epirubicin toxicity']","['grade 3/4 neutropenia and leukopenia or OS and PFS', 'SNP and incidence of grade 3/4 neutropenia and leukopenia, overall (OS) and progression-free survival (PFS']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0346619', 'cui_str': 'Malignant neoplasm of cardio-esophageal junction of stomach'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0040539', 'cui_str': 'TO'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",281.0,0.110024,There was a lack of evidence of an association among any SNPs tested with grade 3/4 neutropenia and leukopenia or OS and PFS.,"[{'ForeName': 'Jai N', 'Initials': 'JN', 'LastName': 'Patel', 'Affiliation': 'Department of Cancer Pharmacology and Pharmacogenomics, Levine Cancer Institute, Atrium Health, Charlotte.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Alliance Statistics and Data Center.'}, {'ForeName': 'Kouros', 'Initials': 'K', 'LastName': 'Owzar', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Mulkey', 'Affiliation': 'Alliance Statistics and Data Center.'}, {'ForeName': 'Jasmine A', 'Initials': 'JA', 'LastName': 'Luzum', 'Affiliation': 'Department of Clinical Pharmacy, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Mamon', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Haller', 'Affiliation': 'Department of Gastrointestinal Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Dragovich', 'Affiliation': 'Department of Hematology/Oncology, Banner MD Anderson Cancer Center, Gilbert, Arizona.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Department of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Bjarnason', 'Affiliation': 'Department of Medical Oncology, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Willet', 'Affiliation': 'Department of Radiation Oncology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Enzinger', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'Center for Personalized Therapeutics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Fuchs', 'Affiliation': 'Department of Medical Oncology, Smilow Cancer Hospital, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'McLeod', 'Affiliation': 'Department of Precision Medicine, USF Taneja College of Pharmacy and the Geriatric Oncology Consortium, Tampa, Florida, USA.'}]",Pharmacogenetics and genomics,['10.1097/FPC.0000000000000442']
709,34152585,"Treatment of Persistent Cough in Subjects with Idiopathic Pulmonary Fibrosis (IPF) with Gefapixant, a P2X3 Antagonist, in a Randomized, Placebo-Controlled Clinical Trial.","INTRODUCTION


Chronic cough is a highly problematic symptom for patients with idiopathic pulmonary fibrosis (IPF); limited therapeutic options are available. We evaluated gefapixant, a P2X3 receptor antagonist, for the treatment of chronic cough in IPF.
METHODS


This randomized, double-blind, placebo-controlled, crossover study included subjects with IPF. Sequence A included gefapixant 50 mg BID (period 1; 14 days) followed by placebo (period 2; 14 days); sequence B had the opposite sequence of treatments. This regimen was specified in a protocol amendment that modified the original active treatment regimen of gefapixant 50 mg BID for 10 days and 150 mg BID for 4 days. Patients randomized to the original treatment regimen were excluded from efficacy analyses but included in safety assessments. The primary efficacy endpoint was change from baseline in awake cough frequency (coughs/hour) from periods 1 and 2 combined. Adverse events (AEs) were monitored throughout the study.
RESULTS


A total of 51 subjects were randomized, 44 of whom were randomized to treatment sequences evaluated in the primary efficacy analysis (i.e., 22 subjects in sequence A and 22 subjects in sequence B); seven subjects received the treatment assigned before the protocol amendment and were excluded from efficacy analyses. The change from baseline in awake cough frequency from periods 1 and 2 combined (mixed model for repeated measures analysis) did not demonstrate a significant reduction versus placebo in cough at day 14 (p = 0.90); in a post hoc analysis of log-transformed data p value for reduction versus placebo at day 14 was 0.07. The most common AEs were related to taste (dysgeusia and ageusia).
CONCLUSIONS


Gefapixant was generally well tolerated but was not associated with a significant improvement in chronic cough in subjects with IPF as defined by the primary endpoint in this study.
TRIAL REGISTRATION


NCT02502097.",2021,"CONCLUSIONS


Gefapixant was generally well tolerated but was not associated with a significant improvement in chronic cough in subjects with IPF as defined by the primary endpoint in this study.
","['A total of 51 subjects', 'patients with idiopathic pulmonary fibrosis (IPF', 'Subjects with Idiopathic Pulmonary Fibrosis (IPF', '22 subjects in sequence A and 22 subjects in sequence B); seven subjects', 'subjects with IPF']","['placebo', 'Placebo']","['chronic cough', 'awake cough frequency', 'Adverse events (AEs', 'taste (dysgeusia and ageusia']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C2364111', 'cui_str': 'Loss of taste'}]",51.0,0.329022,"CONCLUSIONS


Gefapixant was generally well tolerated but was not associated with a significant improvement in chronic cough in subjects with IPF as defined by the primary endpoint in this study.
","[{'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Weill Cornell Medical College, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York City, NY, USA. fjm2003@med.cornell.edu.'}, {'ForeName': 'Amna Sadaf', 'Initials': 'AS', 'LastName': 'Afzal', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, University of Manchester and Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Ford', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Jerry Jing', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'GetStat Solutions, LLC, Palo Alto, CA, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Kitt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pulmonary therapy,['10.1007/s41030-021-00162-9']
710,34151819,Effects of scapular stabilization exercises on posture and muscle imbalances in women with upper crossed syndrome: A randomized controlled trial.,"BACKGROUND


Scapular stabilization exercises can improve forward shoulder posture in young women. However, the effects of optimal exercise protocols on neck and shoulder postures, scapular muscle imbalance and thoracic kyphosis are still unclear.
OBJECTIVES


To investigate the effects of scapular stabilization exercises on neck and shoulder postures, scapular muscle imbalance and thoracic kyphosis in young women with upper crossed syndrome.
METHODS


Thirty-nine women aged 18-25 years with upper crossed syndrome were recruited. Participants were randomly allocated intotwo groups. The exercise group performed scapular stabilization exercises using elastic bands at 10 repetitions/set, 3 sets/day, and 3 days/week for 4 weeks. The control group did not perform any exercises during the experimental period. The cervical and shoulder angles were evaluated using the Kinovea program. A caliper, handheld dynamometer and flexi ruler were used to evaluate the length of the pectoralis minor, strength of the scapular stabilizer muscles and degree of the mid-thoracic curve, respectively.
RESULTS


The exercise group showed significant differences (p< 0.05) in the increase in cervical and shoulder angle, length of the pectoralis minor, and strength of the scapular muscles, except in the degree of mid-thoracic curve compared to the control group.
CONCLUSION


This study indicated that scapular stabilization exercises can improve forward head and shoulder posture, increase the flexibility of the pectoralis minor and strengthen the scapular muscles.",2021,"The exercise group showed significant differences (p< 0.05) in the increase in cervical and shoulder angle, length of the pectoralis minor, and strength of the scapular muscles, except in the degree of mid-thoracic curve compared to the control group.
","['women with upper crossed syndrome', 'young women', 'young women with upper crossed syndrome', 'Thirtyninewomenaged 1825 years with upper crossed syndrome were recruited']","['scapular stabilization exercises', 'optimal exercise protocols', 'exercise group performed scapular stabilization exercises', 'Scapular stabilization exercises']","['posture and muscle imbalances', 'neck and shoulder postures, scapular muscle imbalance and thoracic kyphosis', 'cervical and shoulder angle, length of the pectoralis minor, and strength of the scapular muscles, except in the degree of mid-thoracic curve']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0268496', 'cui_str': 'Oculocerebral syndrome with hypopigmentation'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0224347', 'cui_str': 'Pectoralis minor muscle structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0237401,"The exercise group showed significant differences (p< 0.05) in the increase in cervical and shoulder angle, length of the pectoralis minor, and strength of the scapular muscles, except in the degree of mid-thoracic curve compared to the control group.
","[{'ForeName': 'Haifah', 'Initials': 'H', 'LastName': 'Nitayarak', 'Affiliation': ''}, {'ForeName': 'Pornpimol', 'Initials': 'P', 'LastName': 'Charntaraviroj', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200088']
711,34153931,Development and validation of a nomogram to predict in-hospital cardiac arrest among patients admitted with acute coronary syndrome.,"AIM


This study aimed to develop and validate a nomogram to recognize in-hospital cardiac arrest (CA) in patients with acute coronary syndrome (ACS).
METHODS


This multicenter case-control study reviewed 164 ACS patients who had in-hospital CA and randomly selected 521 ACS patients with no CA experience. We randomly assigned 80% of the participants to a development cohort, 20% of those to an independent validation cohort. The least absolute shrinkage and selection operator (LASSO) regression model was used for data dimension reduction, and multivariable logistic regression analysis was used to develop the CA prediction nomogram. Nomogram performance was assessed with respect to discrimination, calibration, and clinical usefulness.
RESULTS


Seven parameters, including chest pain, Killip class, potassium, BNP, arrhythmia, platelet count, and NEWS, were used to create individualized CA prediction nomograms. The CA prediction nomogram showed good discrimination (C-index of 0.896, 95%CI, 0.865-0.927) and calibration. Application of the CA prediction nomogram in assessments of the validation cohort improved discrimination (C-index of 0.914, 95%CI, 0.873-0.967) and calibration. The results of decision curve analysis demonstrated that the CA prediction nomogram was clinically useful.
CONCLUSION


Our study generated a friendly risk score to recognize in-hospital CA with good discrimination and calibration. Further studies need to establish a pathway to guide the application of the risk score in clinical practice.",2021,"The CA prediction nomogram showed good discrimination (C-index of 0.896, 95%CI, 0.865-0.927) and calibration.","['164 ACS patients who had in-hospital CA and randomly selected 521 ACS patients with no CA experience', 'patients admitted with acute coronary syndrome', 'patients with acute coronary syndrome (ACS']",[],"['chest pain, Killip class, potassium, BNP, arrhythmia, platelet count, and NEWS']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",[],"[{'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0282425', 'cui_str': 'News'}]",521.0,0.0871252,"The CA prediction nomogram showed good discrimination (C-index of 0.896, 95%CI, 0.865-0.927) and calibration.","[{'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Wu', 'Affiliation': 'The School of Nursing, Fujian Medical University, Fujian, China.'}, {'ForeName': 'Dong-Liang', 'Initials': 'DL', 'LastName': 'Yang', 'Affiliation': 'Department of General Education Courses, Cangzhou Medical College, Hebei, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fujian, China. Electronic address: leehong99@126.com.'}, {'ForeName': 'Yan-Song', 'Initials': 'YS', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiovascular Medicine, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fujian, China.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.05.082']
712,34159536,EEG-controlled functional electrical stimulation rehabilitation for chronic stroke: system design and clinical application.,"Stroke is one of the most serious diseases that threaten human life and health. It is a major cause of death and disability in the clinic. New strategies for motor rehabilitation after stroke are undergoing exploration. We aimed to develop a novel artificial neural rehabilitation system, which integrates brain-computer interface (BCI) and functional electrical stimulation (FES) technologies, for limb motor function recovery after stroke. We conducted clinical trials (including controlled trials) in 32 patients with chronic stroke. Patients were randomly divided into the BCI-FES group and the neuromuscular electrical stimulation (NMES) group. The changes in outcome measures during intervention were compared between groups, and the trends of ERD values based on EEG were analyzed for BCI-FES group. Results showed that the increase in Fugl Meyer Assessment of the Upper Extremity (FMA-UE) and Kendall Manual Muscle Testing (Kendall MMT) scores of the BCI-FES group was significantly higher than that in the sham group, which indicated the practicality and superiority of the BCI-FES system in clinical practice. The change in the laterality coefficient (LC) values based on μ-ERD (ΔLC m-ERD ) had high significant positive correlation with the change in FMA-UE(r = 0.6093, P = 0.012), which provides theoretical basis for exploring novel objective evaluation methods.",2021,"Results showed that the increase in Fugl Meyer Assessment of the Upper Extremity (FMA-UE) and Kendall Manual Muscle Testing (Kendall MMT) scores of the BCI-FES group was significantly higher than that in the sham group, which indicated the practicality and superiority of the BCI-FES system in clinical practice.","['chronic stroke', '32 patients with chronic stroke']","['EEG-controlled functional electrical stimulation rehabilitation', 'novel artificial neural rehabilitation system, which integrates brain-computer interface (BCI) and functional electrical stimulation (FES) technologies', 'neuromuscular electrical stimulation (NMES', 'BCI-FES']","['laterality coefficient (LC) values based on μ-ERD', 'Fugl Meyer Assessment of the Upper Extremity (FMA-UE) and Kendall Manual Muscle Testing (Kendall MMT) scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0023114', 'cui_str': 'Handedness'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C0046370', 'cui_str': '2-methylcyclopentadienyl manganese tricarbonyl'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",32.0,0.0471926,"Results showed that the increase in Fugl Meyer Assessment of the Upper Extremity (FMA-UE) and Kendall Manual Muscle Testing (Kendall MMT) scores of the BCI-FES group was significantly higher than that in the sham group, which indicated the practicality and superiority of the BCI-FES system in clinical practice.","[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Neural Engineering & Rehabilitation Laboratory, Department of Biomedical Engineering, College of Precision Instruments and Optoelectronics Engineering, Tianjin University, Tianjin, 300072, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Gu', 'Affiliation': 'Neural Engineering & Rehabilitation Laboratory, Department of Biomedical Engineering, College of Precision Instruments and Optoelectronics Engineering, Tianjin University, Tianjin, 300072, China.'}, {'ForeName': 'Zhongpeng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Neural Engineering & Rehabilitation Laboratory, Department of Biomedical Engineering, College of Precision Instruments and Optoelectronics Engineering, Tianjin University, Tianjin, 300072, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Academy of Medical Engineering and Translational Medicine, Tianjin University, Tianjin, 300072, China.'}, {'ForeName': 'Minpeng', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Neural Engineering & Rehabilitation Laboratory, Department of Biomedical Engineering, College of Precision Instruments and Optoelectronics Engineering, Tianjin University, Tianjin, 300072, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Academy of Medical Engineering and Translational Medicine, Tianjin University, Tianjin, 300072, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Neural Engineering & Rehabilitation Laboratory, Department of Biomedical Engineering, College of Precision Instruments and Optoelectronics Engineering, Tianjin University, Tianjin, 300072, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Ming', 'Affiliation': 'Neural Engineering & Rehabilitation Laboratory, Department of Biomedical Engineering, College of Precision Instruments and Optoelectronics Engineering, Tianjin University, Tianjin, 300072, China. richardming@tju.edu.cn.'}]",Frontiers of medicine,['10.1007/s11684-020-0794-5']
713,34173157,Reduction of impulsivity in patients receiving deep transcranial magnetic stimulation treatment for obesity.,"PURPOSE


Aims of the present study were to investigate a wide array of psychological symptoms through validated psychometric tests, before and after 5 weeks of deep Transcranial Magnetic Stimulation (dTMS) in individuals with obesity, and to identify possible relationships with neuroendocrine parameters.
METHODS


Forty-five patients with obesity (33 F, 12 M; age 48.8 ± 9.9 years; body wt 97.6 ± 14.2 Kg; BMI 36.2 ± 4.2) were randomized into two groups: 26 received high frequency (HF) dTMS and 19 Sham stimulation for 5 weeks. At baseline and after the 5-week treatment, all patients underwent the following psychometric evaluations: Food Cravings Questionnaire-Trait (FCQ-T) and its subscales, Barratt Impulsiveness Scale-11 (BIS-11), State and Trait Anxiety Inventory (STAI-y1 and STAI-y2), and Beck Depression Inventory (BDI). Hormonal and neuroendocrine markers were assessed at the first and last dTMS session.
RESULTS


By adjusting for baseline variables and treatment arms, a significant decrease in body wt and BMI was found in HF group, both with univariate (p = 0.019) and multivariate analyses (p = 0.012). Impulsivity significantly decreased in HF group, both with univariate (p = 0.031) and multivariate analyses (p = 0.011). A positive association between the impulsivity score change and the leptin level variation (p = 0.031) was found.
CONCLUSION


The decrease of impulsivity together with the BMI reduction in individuals with obesity, treated with real stimulation, suggests that impulsivity may be a risk factor for obesity. Treatment with dTMS revealed to be effective in reducing both BMI and impulsivity by enhancing inhibitory capacity of Pre-Frontal Cortex (PFC), and modulating neuroendocrine system, especially leptin.",2021,"Impulsivity significantly decreased in HF group, both with univariate (p = 0.031) and multivariate analyses (p = 0.011).","['individuals with obesity', 'Forty-five patients with obesity (33\u2009F, 12\u2009M; age 48.8\u2009±\u20099.9\u2009years; body wt 97.6\u2009±\u200914.2\u2009Kg', 'patients receiving deep transcranial magnetic stimulation treatment for obesity']","['deep Transcranial Magnetic Stimulation (dTMS', 'high frequency (HF) dTMS', 'dTMS']","['Food Cravings Questionnaire-Trait (FCQ-T) and its subscales, Barratt Impulsiveness Scale-11 (BIS-11), State and Trait Anxiety Inventory (STAI-y1 and STAI-y2), and Beck Depression Inventory (BDI', 'Impulsivity', 'impulsivity score change and the leptin level variation', 'body wt and BMI', 'Hormonal and neuroendocrine markers', 'BMI and impulsivity by enhancing inhibitory capacity of Pre-Frontal Cortex (PFC), and modulating neuroendocrine system, especially leptin', 'Reduction of impulsivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",45.0,0.0252153,"Impulsivity significantly decreased in HF group, both with univariate (p = 0.031) and multivariate analyses (p = 0.011).","[{'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Luzi', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy. livio.luzi@multimedica.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gandini', 'Affiliation': 'Department of Experimental Oncology, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Massarini', 'Affiliation': 'Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Sesto San Giovanni, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Bellerba', 'Affiliation': 'Department of Experimental Oncology, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Ileana', 'Initials': 'I', 'LastName': 'Terruzzi', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Senesi', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Macrì', 'Affiliation': 'Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Sesto San Giovanni, Milan, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ferrulli', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}]",Endocrine,['10.1007/s12020-021-02802-1']
714,34173129,Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results.,"PURPOSE


Results are presented from 2 to 3 trials investigating oral octreotide capsules (OOC) as an alternative to injectable somatostatin receptor ligands (iSRLs) in the treatment of acromegaly.
METHODS


CH-ACM-01 was an open-label trial (N = 155) and CHIASMA OPTIMAL was a double-blind placebo-controlled (DPC) trial (N = 56), both investigating OOC as maintenance therapy for patients with acromegaly who were biochemical responders receiving iSRLs.
RESULTS


Baseline characteristics in both trials reflected those expected of patients with acromegaly responding to treatment and were similar between trials, despite differences in inclusion criteria. OOC demonstrated a consistent degree of biochemical response across trials, with 65% of patients in CH-ACM-01 maintaining response during the core period and 64% of patients in CHIASMA OPTIMAL at the end of the DPC. Mean insulin-like growth factor I (IGF-I) levels remained within inclusion criteria at the end of treatment in both trials. Of 110 patients entering the fixed-dose phase in CH-ACM-01, 80% maintained or improved acromegaly symptoms from baseline to the end of treatment. Over 85% of patients in both trials elected to continue into the extension phases. OOC were found to be well tolerated across both trials, and no dose-related adverse events were observed.
CONCLUSIONS


OOC demonstrated remarkably consistent results for biochemical response, durability of response, and preference to continue with oral treatment across these 2 complementary landmark phase 3 trials, despite differences in the design of each. Trial registration NCT03252353 (August 2017), NCT01412424 (August 2011).",2021,Mean insulin-like growth factor I (IGF-I) levels remained within inclusion criteria at the end of treatment in both trials.,['patients with acromegaly who were biochemical responders receiving iSRLs'],"['Oral octreotide capsules', 'octreotide capsules (OOC']","['Mean insulin-like growth factor I (IGF-I) levels', 'biochemical response, durability of response, and preference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001206', 'cui_str': 'Acromegaly'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0074830', 'cui_str': 'Somatostatin Receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]",,0.183265,Mean insulin-like growth factor I (IGF-I) levels remained within inclusion criteria at the end of treatment in both trials.,"[{'ForeName': 'Artak', 'Initials': 'A', 'LastName': 'Labadzhyan', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, 90048, USA. Artak.Labadzhyan@cshs.org.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Nachtigall', 'Affiliation': 'MGH Neuroendocrine and Pituitary Center, Chestnut Hill, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fleseriu', 'Affiliation': 'Pituitary Center, Oregon Health & Sciences University, Portland, OR, USA.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Gordon', 'Affiliation': 'Allegheny Neuroendocrinology Center, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Molitch', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kennedy', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Samson', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Greenman', 'Affiliation': 'Sourasky Medical Center and Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Biermasz', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bolanowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Haviv', 'Affiliation': 'Chiasma, Inc., Needham, MA, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Ludlam', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, 90048, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Patou', 'Affiliation': 'Chiasma, Inc., Needham, MA, USA.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Strasburger', 'Affiliation': 'Charite Universitatsmedizin, Berlin, Germany.'}]",Pituitary,['10.1007/s11102-021-01163-2']
715,34171973,"Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study.","OBJECTIVE


EMPOwER, a double-blind, randomised, phase 3 study, evaluated the efficacy and safety of erenumab in adults with episodic migraine from Asia, the Middle East, and Latin America.
METHODS


Randomised patients (N = 900) received monthly subcutaneous injections of placebo, erenumab 70 mg, or 140 mg (3:3:2) for 3 months. Primary endpoint was change from baseline in monthly migraine days at Month 3. Other endpoints included achievement of ≥50%, ≥75%, and 100% reduction in monthly migraine days, change in monthly acute migraine-specific medication treatment days, patient-reported outcomes, and safety assessment.
RESULTS


At baseline, mean (standard deviation) age was 37.5 (9.9) years, 81.9% were women, and monthly migraine days was 8.2 (2.8). At Month 3, change from baseline in monthly migraine days (primary endpoint) was -3.1, -4.2, and -4.8 days for placebo, erenumab 70 mg, and erenumab 140 mg, respectively, with a statistically significant difference for erenumab versus placebo (P = 0.002 [70 mg], P < 0.001 [140 mg]). Both erenumab doses were also significantly superior to placebo on all secondary endpoints, including the proportion of patients achieving ≥50% reduction from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication treatment days and change from baseline in the Headache Impact Test-6™ scores. The safety profile of erenumab was comparable with placebo; no new safety signals were observed.
CONCLUSIONS


This study of erenumab in patients with episodic migraine from Asia, the Middle East, and Latin America met all primary and secondary endpoints. A consistent numerical benefit was observed with erenumab 140 mg versus erenumab 70 mg across all efficacy endpoints. These findings extend evidence of erenumab's efficacy and safety to patients under-represented in previous trials. ClinicalTrials.gov identifier : NCT03333109.",2021,"Both erenumab doses were also significantly superior to placebo on all secondary endpoints, including the proportion of patients achieving ≥50% reduction from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication treatment days and change from baseline in the Headache Impact Test-6™ scores.","['patients from Asia, the Middle East, and Latin America', 'adults with episodic migraine from Asia, the Middle East, and Latin America', 'patients with episodic migraine from Asia, the Middle East, and Latin America met all primary and secondary endpoints', 'Randomised patients (N\u2009=\u2009900) received']","['monthly subcutaneous injections of placebo, erenumab', 'placebo', 'erenumab']","['new safety signals', 'efficacy and safety', 'monthly migraine days, change in monthly acute migraine-specific medication treatment days, patient-reported outcomes, and safety assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0026068', 'cui_str': 'Middle east country'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.584029,"Both erenumab doses were also significantly superior to placebo on all secondary endpoints, including the proportion of patients achieving ≥50% reduction from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication treatment days and change from baseline in the Headache Impact Test-6™ scores.","[{'ForeName': 'Shuu-Jiun', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': 'Neurological Institute, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Artemio A', 'Initials': 'AA', 'LastName': 'Roxas', 'Affiliation': 'The Medical City, Pasig, Philippines.'}, {'ForeName': 'Bibiana', 'Initials': 'B', 'LastName': 'Saravia', 'Affiliation': 'Mautalen Salud e Investigación, Buenos Aires, Argentina.'}, {'ForeName': 'Byung-Kun', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Debashish', 'Initials': 'D', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Neurology, G B Pant Institute of Post Graduate Medical Education and Research, New Delhi, India.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Riachi', 'Affiliation': 'Lebanese American University Medical Center Rizk Hospital, Beirut, Lebanon.'}, {'ForeName': 'Mei-Ling Sharon', 'Initials': 'MS', 'LastName': 'Tai', 'Affiliation': 'University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Surat', 'Initials': 'S', 'LastName': 'Tanprawate', 'Affiliation': 'Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Tai Tran', 'Initials': 'TT', 'LastName': 'Ngoc', 'Affiliation': 'University Medical Center, University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Yi Jing', 'Initials': 'YJ', 'LastName': 'Zhao', 'Affiliation': 'National Neuroscience Institute - Singapore General Hospital Campus, Singapore.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Shaloo', 'Initials': 'S', 'LastName': 'Pandhi', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Subhayan', 'Initials': 'S', 'LastName': 'Mondal', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Tenenbaum', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Hours-Zesiger', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Cephalalgia : an international journal of headache,['10.1177/03331024211024160']
716,34170930,A clinical diabetes risk prediction model for prediabetic women with prior gestational diabetes.,"INTRODUCTION


Without treatment, prediabetic women with a history of gestational diabetes mellitus (GDM) are at greater risk for developing type 2 diabetes compared with women without a history of GDM. Both intensive lifestyle intervention and metformin can reduce risk. To predict risk and treatment response, we developed a risk prediction model specifically for women with prior GDM.
METHODS


The Diabetes Prevention Program was a randomized controlled trial to evaluate the effectiveness of intensive lifestyle intervention, metformin (850mg twice daily), and placebo in preventing diabetes. Data from the Diabetes Prevention Program (DPP) was used to conduct a secondary analysis to evaluate 11 baseline clinical variables of 317 women with prediabetes and a self-reported history of GDM to develop a 3-year diabetes risk prediction model using Cox proportional hazards regression. Reduced models were explored and compared with the main model.
RESULTS


Within three years, 82 (25.9%) women developed diabetes. In our parsimonious model using 4 of 11 clinical variables, higher fasting glucose and hemoglobin A1C were each associated with greater risk for diabetes (each hazard ratio approximately 1.4), and there was an interaction between treatment arm and BMI suggesting that metformin was more effective relative to no treatment for BMI ≥ 35kg/m2 than BMI < 30kg/m2. The model had fair discrimination (bias corrected C index = 0.68) and was not significantly different from our main model using 11 clinical variables. The estimated incidence of diabetes without treatment was 37.4%, compared to 20.0% with intensive lifestyle intervention or metformin treatment for women with a prior GDM.
CONCLUSIONS


A clinical prediction model was developed for individualized decision making for prediabetes treatment in women with prior GDM.",2021,The model had fair discrimination (bias corrected C index = 0.68) and was not significantly different from our main model using 11 clinical variables.,"['317 women with prediabetes and a self-reported history of GDM to develop a 3-year diabetes risk', 'prediabetic women with prior gestational diabetes', 'women with prior GDM', 'prediabetic women with a history of gestational diabetes mellitus (GDM']","['placebo', 'metformin', 'Diabetes Prevention Program (DPP', 'intensive lifestyle intervention, metformin']","['fasting glucose and hemoglobin A1C', 'diabetes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2183115', 'cui_str': 'History of gestational diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",317.0,0.051437,The model had fair discrimination (bias corrected C index = 0.68) and was not significantly different from our main model using 11 clinical variables.,"[{'ForeName': 'Bernice', 'Initials': 'B', 'LastName': 'Man', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Schwartz', 'Affiliation': 'Department of Medical Education, Department of Pediatrics, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Pugach', 'Affiliation': 'Institute for Health and Research Policy, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Yinglin', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}]",PloS one,['10.1371/journal.pone.0252501']
717,34153272,"Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND


Respiratory complications are an important cause of postoperative morbidity. We aimed to investigate whether continuous positive airway pressure (CPAP) administered immediately after major abdominal surgery could prevent postoperative morbidity.
METHODS


PRISM was an open-label, randomised, phase 3 trial done at 70 hospitals across six countries. Patients aged 50 years or older who were undergoing elective major open abdominal surgery were randomly assigned (1:1) to receive CPAP within 4 h of the end of surgery or usual postoperative care. Patients were randomly assigned using a computer-generated minimisation algorithm with inbuilt concealment. The primary outcome was a composite of pneumonia, endotracheal re-intubation, or death within 30 days after randomisation, assessed in the intention-to-treat population. Safety was assessed in all patients who received CPAP. The trial is registered with the ISRCTN registry, ISRCTN56012545.
FINDINGS


Between Feb 8, 2016, and Nov 11, 2019, 4806 patients were randomly assigned (2405 to the CPAP group and 2401 to the usual care group), of whom 4793 were included in the primary analysis (2396 in the CPAP group and 2397 in the usual care group). 195 (8·1%) of 2396 patients in the CPAP group and 197 (8·2%) of 2397 patients in the usual care group met the composite primary outcome (adjusted odds ratio 1·01 [95% CI 0·81-1·24]; p=0·95). 200 (8·9%) of 2241 patients in the CPAP group had adverse events. The most common adverse events were claustrophobia (78 [3·5%] of 2241 patients), oronasal dryness (43 [1·9%]), excessive air leak (36 [1·6%]), vomiting (26 [1·2%]), and pain (24 [1·1%]). There were two serious adverse events: one patient had significant hearing loss and one patient had obstruction of their venous catheter caused by a CPAP hood, which resulted in transient haemodynamic instability.
INTERPRETATION


In this large clinical effectiveness trial, CPAP did not reduce the incidence of pneumonia, endotracheal re-intubation, or death after major abdominal surgery. Although CPAP has an important role in the treatment of respiratory failure after surgery, routine use of prophylactic post-operative CPAP is not recommended.
FUNDING


National Institute for Health Research, Barts Charity, Intersurgical, Association of Anaesthetists, and Sapienza Università di Roma.",2021,"The most common adverse events were claustrophobia (78 [3·5%] of 2241 patients), oronasal dryness (43 [1·9%]), excessive air leak (36 [1·6%]), vomiting (26 [1·2%]), and pain (24 [1·1%]).","['Patients aged 50 years or older who were undergoing elective major open abdominal surgery', '195 (8·1%) of 2396 patients in the CPAP group and 197 (8·2%) of 2397 patients in the usual care group met the composite primary outcome ', 'Between Feb 8, 2016, and Nov 11, 2019, 4806 patients were randomly assigned (2405 to the CPAP group and 2401 to the usual care group), of whom 4793 were included in the primary analysis (2396 in the CPAP group and 2397 in the usual care group', '70 hospitals across six countries', 'after major abdominal surgery (PRISM']","['continuous positive airway pressure (CPAP', 'Postoperative continuous positive airway pressure', 'computer-generated minimisation algorithm with inbuilt concealment', 'CPAP', 'CPAP within 4 h of the end of surgery or usual postoperative care']","['excessive air leak', 'transient haemodynamic instability', 'composite of pneumonia, endotracheal re-intubation, or death within 30 days after randomisation, assessed in the intention-to-treat population', 'hearing loss', 'incidence of pneumonia, endotracheal re-intubation, or death', 'pneumonia, re-intubation, and death', 'oronasal dryness', 'adverse events', 'vomiting', 'pain', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",4806.0,0.238398,"The most common adverse events were claustrophobia (78 [3·5%] of 2241 patients), oronasal dryness (43 [1·9%]), excessive air leak (36 [1·6%]), vomiting (26 [1·2%]), and pain (24 [1·1%]).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00089-8']
718,34155580,Administration of a standard dose of vonoprazan fumarate delays gastric emptying in Japanese healthy adults: a prospective clinical trial.,"BACKGROUND


There is no established view of how gastric acid suppression affects the time for gastric emptying. Vonoprazan fumarate shows potent and durable gastric acid inhibitory effects, but its effects on gastric emptying have not been studied widely. We investigated the effects of vonoprazan fumarate on gastric emptying and measured serum gastrin and plasma ghrelin levels in healthy adults.
METHODS


Ten participants were administered 10 mg vonoprazan fumarate daily for 14 days, then 20 mg vonoprazan fumarate daily for 14 days. The gastric emptying breath test was performed and serum gastrin levels were measured at baseline and after each medication administration period. The protocol was then repeated, with the gastric emptying breath test and serum gastrin and plasma desacyl-ghrelin levels measured at baseline and the end of the medication trial.
RESULTS


Mean serum gastrin levels increased in a dose-dependent manner [baseline: 104.7 ± 50.4, after 10 mg protocol: 328 ± 123.8, after 20 mg protocol: 555 ± 378.8 (pg/mL, mean ± standard deviation), p = 0.0008]. There was a significant difference between the gastric emptying breath test Tmax at baseline and just after the 20 mg protocol (baseline: 45.5 ± 15.3, after 20 mg protocol: 60.5 ± 19.6 min, p = 0.0418). Plasma desacyl-ghrelin levels increased significantly just after the 20 mg protocol compared to those at baseline [baseline: 222.3 ± 106.4, after 20 mg protocol: 366.2 ± 178.6 (fmol/mL), p = 0.0008].
CONCLUSIONS


In healthy adults, 14 days of vonoprazan fumarate administration at 20 mg/day delayed gastric emptying.
TRIAL REGISTRATION


This clinical trial was registered in the University hospital Medical Information Network Clinical Trial Registry (Trial No. UMIN000039199 and UMIN000042969).",2021,"Mean serum gastrin levels increased in a dose-dependent manner [baseline: 104.7 ± 50.4, after 10 mg protocol: 328 ± 123.8, after 20 mg protocol: 555 ± 378.8 (pg/mL, mean ± standard deviation), p = 0.0008].","['Japanese healthy adults', 'healthy adults']","['Vonoprazan fumarate', 'vonoprazan fumarate delays gastric emptying', 'vonoprazan fumarate']","['serum gastrin levels', 'gastric emptying breath test', 'gastric emptying breath test Tmax', 'gastric emptying and measured serum gastrin and plasma ghrelin levels', 'Mean serum gastrin levels', 'Plasma desacyl-ghrelin levels', 'gastric emptying breath test and serum gastrin and plasma desacyl-ghrelin levels']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C4080009', 'cui_str': 'Vonoprazan'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}]","[{'cui': 'C0428386', 'cui_str': 'Serum gastrin measurement'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0965048', 'cui_str': 'ghrelin, des-n-octanoyl'}]",10.0,0.149821,"Mean serum gastrin levels increased in a dose-dependent manner [baseline: 104.7 ± 50.4, after 10 mg protocol: 328 ± 123.8, after 20 mg protocol: 555 ± 378.8 (pg/mL, mean ± standard deviation), p = 0.0008].","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Ota', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan. clash_kaz@yahoo.co.jp.'}, {'ForeName': 'Toshihisa', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Kawaguchi', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Iwatsubo', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}, {'ForeName': 'Akitoshi', 'Initials': 'A', 'LastName': 'Hakoda', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Nishida', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Sasaki', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kikutani', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Tawa', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kanaoka', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Osaka', 'Affiliation': 'Central Clinical Laboratory, Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Osaka, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Takii', 'Affiliation': 'Department of Gastroenterology, Osaka Medical and Pharmaceutical University Mishima-Minami Hospital, Takatsuki, Osaka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nakada', 'Affiliation': 'Department of Laboratory Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Higuchi', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-021-01801-3']
719,34170392,"Impact of dietary supplementation with resistant dextrin (NUTRIOSE ® ) on satiety, glycaemia, and related endpoints, in healthy adults.","PURPOSE


Resistant dextrin (RD) supplementation has been shown to alter satiety, glycaemia, and body weight, in overweight Chinese men; however, there are limited data on its effects in other demographic groups. Here, we investigated the effects of RD on satiety in healthy adults living in the United Kingdom.
METHODS


20 normal weight and 16 overweight adults completed this randomised controlled cross-over study. Either RD (14 g/day NUTRIOSE ®  FB06) or maltodextrin control was consumed in mid-morning and mid-afternoon preload beverages over a 28-day treatment period with crossover after a 28-day washout. During 10-h study visits (on days 1, 14, and 28 of each treatment period), satietogenic, glycaemic and anorectic hormonal responses to provided meals were assessed.
RESULTS


Chronic supplementation with RD was associated with higher fasted satiety scores at day 14 (P = 0.006) and day 28 (P = 0.040), compared to control. RD also increased satiety after the mid-morning intervention drink, but it was associated with a reduction in post-meal satiety following both the lunch and evening meals (P < 0.01). The glycaemic response to the mid-morning intervention drink (0-30 min) was attenuated following RD supplementation (P < 0.01). Whilst not a primary endpoint we also observed lower systolic blood pressure at day 14 (P = 0.035) and 28 (P = 0.030), compared to day 1, following RD supplementation in the normal weight group. Energy intake and anthropometrics were unaffected.
CONCLUSIONS


RD supplementation modified satiety and glycaemic responses in this cohort, further studies are required to determine longer-term effects on body weight control and metabolic markers. CLINICALTRIALS.
GOV REGISTRATION


NCT02041975 (22/01/2014).",2021,"Whilst not a primary endpoint we also observed lower systolic blood pressure at day 14 (P = 0.035) and 28 (P = 0.030), compared to day 1, following RD supplementation in the normal weight group.","['healthy adults living in the United Kingdom', 'overweight Chinese men', '20 normal weight and 16 overweight adults', 'healthy adults']","['dietary supplementation with resistant dextrin (NUTRIOSE ® ', 'Resistant dextrin (RD) supplementation', 'RD', 'maltodextrin control']","['glycaemic response', 'satiety, glycaemia, and body weight', 'Energy intake and anthropometrics', 'systolic blood pressure', 'fasted satiety scores', 'satiety', 'satiety and glycaemic responses', 'satietogenic, glycaemic and anorectic hormonal responses']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0011808', 'cui_str': 'Dextrins'}, {'cui': 'C3493180', 'cui_str': 'NUTRIOSE'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}]",,0.069496,"Whilst not a primary endpoint we also observed lower systolic blood pressure at day 14 (P = 0.035) and 28 (P = 0.030), compared to day 1, following RD supplementation in the normal weight group.","[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Hobden', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Pharmacy and Food, The University of Reading, Reading, UK.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Commane', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle, UK. daniel.commane@northumbria.ac.uk.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Guérin-Deremaux', 'Affiliation': 'Department of Nutrition and Health, Roquette, Lestrem, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wils', 'Affiliation': 'Department of Nutrition and Health, Roquette, Lestrem, France.'}, {'ForeName': 'Clementine', 'Initials': 'C', 'LastName': 'Thabuis', 'Affiliation': 'Department of Nutrition and Health, Roquette, Lestrem, France.'}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Martin-Morales', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Pharmacy and Food, The University of Reading, Reading, UK.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Wolfram', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Pharmacy and Food, The University of Reading, Reading, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dìaz', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Pharmacy and Food, The University of Reading, Reading, UK.'}, {'ForeName': 'Sineaid', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Pharmacy and Food, The University of Reading, Reading, UK.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Morais', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Pharmacy and Food, The University of Reading, Reading, UK.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Rowland', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Pharmacy and Food, The University of Reading, Reading, UK.'}, {'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Gibson', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Pharmacy and Food, The University of Reading, Reading, UK.'}, {'ForeName': 'Orla B', 'Initials': 'OB', 'LastName': 'Kennedy', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Pharmacy and Food, The University of Reading, Reading, UK.'}]",European journal of nutrition,['10.1007/s00394-021-02618-9']
720,34170389,Pharmacodynamics of cerebrospinal fluid asparagine after asparaginase.,"PURPOSE


We evaluated effects of asparaginase dosage, schedule, and formulation on CSF asparagine in children with acute lymphoblastic leukemia (ALL).
METHODS


We evaluated CSF asparagine (2114 samples) and serum asparaginase (5007 samples) in 482 children with ALL treated on the Total XVI study (NCT00549848). Patients received one or two 3000 IU/m 2  IV pegaspargase doses during induction and were then randomized in continuation to receive 2500 IU/m 2  or 3500 IU/m 2  IV intermittently (four doses) on the low-risk (LR) or continuously (15 doses) on the standard/high risk (SHR) arms. A pharmacokinetic-pharmacodynamic model was used to estimate the duration of CSF asparagine depletion below 1 uM.
RESULTS


During induction, CSF asparagine depletion after two doses of pegaspargase was twice as long as one dose (median 30.7 vs 15.3 days, p < 0.001). During continuation, the higher dose increased the CSF asparagine depletion duration by only 9% on the LR and 1% in the SHR arm, consistent with the nonlinear pharmacokinetics of serum asparaginase. Pegaspargase caused a longer CSF asparagine depletion duration (1.3-5.3-fold) compared to those who were switched to erwinase (p < 0.001). The median (quartile range) serum asparaginase activity needed to maintain CSF asparagine below 1 µM was 0.44 (0.20, 0.99) IU/mL. Although rare, CNS relapse was higher with decreased CSF asparagine depletion (p = 0.0486); there was no association with relapse at any site (p = 0.3).
CONCLUSIONS


The number of pegaspargase doses has a stronger influence on CSF asparagine depletion than did dosage, pegaspargase depleted CSF asparagine longer than erwinase, and CSF asparagine depletion may prevent CNS relapses.",2021,"Although rare, CNS relapse was higher with decreased CSF asparagine depletion (p = 0.0486); there was no association with relapse at any site (p = 0.3).
","['482 children with ALL treated on the Total XVI study (NCT00549848', 'children with acute lymphoblastic leukemia (ALL']","['CSF asparagine', ' IU/mL']","['CSF asparagine depletion duration', 'median (quartile range) serum asparaginase activity needed to maintain CSF asparagine below 1\xa0µM', 'CNS relapses', 'duration of CSF asparagine depletion', 'CSF asparagine depletion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0003995', 'cui_str': 'Asparagine'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}]","[{'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0003995', 'cui_str': 'Asparagine'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",482.0,0.0559922,"Although rare, CNS relapse was higher with decreased CSF asparagine depletion (p = 0.0486); there was no association with relapse at any site (p = 0.3).
","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Panetta', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Mail Stop 260, Memphis, TN, 38105, US.""}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Mail Stop 260, Memphis, TN, 38105, US.""}, {'ForeName': 'Teodoro', 'Initials': 'T', 'LastName': 'Bottiglieri', 'Affiliation': 'Center of Metabolomics, Institute of Metabolic Disease, Baylor Scott and White Research Institute, Dallas, TX, US.'}, {'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Arning', 'Affiliation': 'Center of Metabolomics, Institute of Metabolic Disease, Baylor Scott and White Research Institute, Dallas, TX, US.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, US.""}, {'ForeName': 'Seth E', 'Initials': 'SE', 'LastName': 'Karol', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, US.""}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Mail Stop 260, Memphis, TN, 38105, US.""}, {'ForeName': 'Yinmei', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, US.""}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Inaba', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, US.""}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, US.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jeha', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, US.""}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Relling', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Mail Stop 260, Memphis, TN, 38105, US. mary.relling@stjude.org.""}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-021-04315-0']
721,34173895,"Act Healthy: A Randomized Clinical Trial Evaluating a Behavioral Activation Intervention to Address Substance Use and Medication Adherence Among Low-Income, Black/African American Individuals Living with HIV/AIDS.","There is a need for parsimonious behavioral interventions to support HIV and substance use treatment outcomes for low-income, Black/African American individuals living with HIV. This randomized clinical trial (N = 61) evaluated Act Healthy (AH), an integrated behavioral intervention to reduce substance use and improve medication adherence, compared to supportive counseling (SC) plus Life-Steps medication adherence counseling on substance use, craving, adherence-related outcomes, and depression over one year. Participants in AH had significantly steeper decreases in cravings compared to SC, but no significant differences in substance use. Across both groups, there was a significant increase in probability of being on antiretroviral therapy (ART) (86% on ART at 12 months vs. 56% at baseline), and a significant decrease in medication nonadherence. Findings provide preliminary support for an intervention to reduce cravings and strategies to improve ART use in a hard-to-reach, vulnerable population at high risk for poor treatment outcomes and ongoing HIV transmission. TRIAL REGISTRATION: ClinicalTrials.gov trial registration number: identifier: NCT01351454. Retrospectively registered on May 10, 2011.",2021,"Participants in AH had significantly steeper decreases in cravings compared to SC, but no significant differences in substance use.","['Low-Income, Black/African American Individuals', 'Act Healthy', 'low-income, Black/African American individuals living with HIV']","['Behavioral Activation Intervention', 'Act Healthy (AH), an integrated behavioral intervention to reduce substance use and improve medication adherence, compared to supportive counseling (SC) plus Life-Steps\xa0medication adherence counseling']","['probability of being on antiretroviral therapy (ART', 'cravings', 'medication nonadherence']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0369919', 'cui_str': 'Reducing substance'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C3697360', 'cui_str': 'Supportive counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0746935', 'cui_str': 'Noncompliance with medication regimen'}]",,0.117421,"Participants in AH had significantly steeper decreases in cravings compared to SC, but no significant differences in substance use.","[{'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Magidson', 'Affiliation': 'Department of Psychology, University of Maryland, 4094 Campus Drive, College Park, Maryland, USA. jmagidso@umd.edu.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Belus', 'Affiliation': 'Department of Psychology, University of Maryland, 4094 Campus Drive, College Park, Maryland, USA.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Seitz-Brown', 'Affiliation': 'Department of Psychology, University of Maryland, 4094 Campus Drive, College Park, Maryland, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Tralka', 'Affiliation': 'Department of Psychology, University of Maryland, 4094 Campus Drive, College Park, Maryland, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'Department of Psychology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Stacey B', 'Initials': 'SB', 'LastName': 'Daughters', 'Affiliation': 'Department of Psychology and Neuroscience, UNC Chapel-Hill, Chapel Hill, NC, USA.'}]",AIDS and behavior,['10.1007/s10461-021-03354-1']
722,34155732,"A randomised, double-blind study investigating the relationship between early childhood trauma and the rewarding effects of morphine.","Experiences of childhood trauma (abuse and neglect) are disproportionately higher in those with opioid use disorder (OUD). Childhood trauma may affect the reinforcing and rewarding properties of opioid drugs and responses to pain, potentially via developmental changes to the endogenous opioid system. This has been supported by preclinical research, yet this has not been investigated in non-addicted humans. Physically healthy participants with either a history of severe childhood trauma or no previous history of childhood trauma attended two sessions where they received either an intramuscular active dose of morphine (0.15 mg/kg) or a very low dose control (0.01 mg/kg) in a randomised, double-blind crossover design. Sessions were held 1 week apart. Participants' physical pain threshold and tolerance were measured pre- and post-drug administration using the cold water pressor test, alongside acute subjective and behavioural responses over 2.5 h. The trauma group reported liking the effects of morphine, feeling more euphoric and wanting more of the drug over the session, as well as feeling less nauseous, dizzy, and dislike of the effects of morphine compared to the non-trauma comparison group. Morphine increased pain threshold and tolerance, yet this did not differ between the groups. Childhood trauma may therefore sensitise individuals to the pleasurable and motivational effects of opioids and reduce sensitivity to the negative effects, providing compelling evidence for individual differences in opioid reward sensitivity. This may explain the link between childhood trauma and vulnerability to OUD, with consequent implications on interventions for OUD, the prescribing of opioids, and reducing stigmas surrounding OUD.",2021,"Participants' physical pain threshold and tolerance were measured pre- and post-drug administration using the cold water pressor test, alongside acute subjective and behavioural responses over 2.5 h.",['Physically healthy participants with either a history of severe childhood trauma or no previous history of childhood trauma attended two sessions'],"['Morphine', 'intramuscular active dose of morphine', 'morphine']","['pain threshold and tolerance', 'physical pain threshold and tolerance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.10059,"Participants' physical pain threshold and tolerance were measured pre- and post-drug administration using the cold water pressor test, alongside acute subjective and behavioural responses over 2.5 h.","[{'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Carlyle', 'Affiliation': 'Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Broomby', 'Affiliation': 'Anaesthesia & Pain Management, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Simpson', 'Affiliation': 'Anaesthesia & Pain Management, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hannon', 'Affiliation': 'Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Fawaz', 'Affiliation': 'Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'O Merve', 'Initials': 'OM', 'LastName': 'Mollaahmetoglu', 'Affiliation': 'Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Drain', 'Affiliation': 'Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'Mohammod', 'Initials': 'M', 'LastName': 'Mostazir', 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Celia J A', 'Initials': 'CJA', 'LastName': 'Morgan', 'Affiliation': 'Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK.'}]",Addiction biology,['10.1111/adb.13047']
723,34161586,Changes in Biomarkers of Cigarette Smoke Exposure After 6 Days of Switching Exclusively or Partially to Use of the JUUL System with Two Nicotine Concentrations: A Randomized Controlled Confinement Study in Adult Smokers.,"INTRODUCTION


Evidence suggests that cigarette smokers who switch to electronic nicotine delivery systems (ENDS) reduce their exposure to harmful toxicants and carcinogens. It is unclear if dual-use is associated with decreases in exposure to toxicants.
METHODS


This parallel-group confinement study assessed changes in biomarkers of exposure (BOEs) over six days among healthy adult smokers who were randomized into 1 of 11 study groups: eight JUUL-brand System (JUUL) groups (4 JUUL flavors [Virginia Tobacco, Menthol, Mint, Mango] × 2 nicotine concentrations [5.0% or 3.0% by weight]); Dual-Use group used preferred JUUL flavor (5.0% nicotine) and ≤50% usual brand (UB) cigarettes/day; UB Cigarette group and one group abstained from all tobacco/nicotine product use (Abstinence group). Urine and blood analysis assessed changes in primary BOE endpoints (NNAL, 3-HPMA, MHBMA, S-PMA COHb) and secondary BOE endpoints (NNN, HMPMA, CEMA, 1-OHP, O-toluidine, 2-NA, 4-ABP) among 279 adult smokers.
RESULTS


In JUUL groups, median percent reductions in primary BOEs (Day 6-Baseline) were 90%-≥100% of Abstinence; there were no significant differences between JUUL groups and Abstinence. All reductions in JUUL groups were substantially and statistically significantly greater than reductions in the UB Cigarette group (ps < 0.025). Median reductions in primary BOEs in the Dual-Use group were 43%-55% of Abstinence. Similar results were observed for secondary BOEs.
CONCLUSION


This study suggests that the use of JUUL as a complete or partial substitute (i.e., dual-use with ≥50% reduction in cigarette consumption) for combustible cigarettes can substantially reduce exposure to multiple toxins associated with cigarette smoking.
IMPLICATIONS


This study adds to the growing body of evidence supporting the utility of ENDS products as potentially reduced-harm alternatives to cigarettes for adult smokers. Adult smokers who switched completely from cigarette smoking to use of the JUUL System (""JUUL"") in two nicotine concentrations (5.0% and 3.0%) and four flavors significantly reduced their exposure to multiple classes of cigarette-related toxicants. Additionally, smokers who used JUUL and continued smoking but reduced their daily cigarette consumption by ≥50% (dual users) also significantly reduced their toxicant exposure compared to cigarette smoking.",2021,All reductions in JUUL groups were substantially and statistically significantly greater than reductions in the UB Cigarette group (ps<0.025).,"['279 adult smokers', 'cigarette smokers who switch to', 'adult smokers', 'healthy adult smokers who were randomized into 1 of 11 study groups', 'Adult smokers who switched completely from cigarette smoking', 'Adult Smokers']","['JUUL', 'electronic nicotine delivery systems (ENDS', 'eight JUUL-brand System (JUUL) groups (4 JUUL flavors [Virginia Tobacco, Menthol, Mint, Mango] × 2 nicotine concentrations [5.0% or 3.0% by weight]); Dual Use group used preferred JUUL flavor (5.0% nicotine) and ≤50% usual brand (UB) cigarettes/day; UB Cigarette group, and one group abstained from all tobacco/nicotine product use (Abstinence group']","['biomarkers of exposure (BOEs', 'Cigarette Smoke Exposure', 'Urine and blood analysis assessed changes in primary BOE endpoints (NNAL, 3-HPMA, MHBMA, S-PMA COHb) and secondary BOE endpoints (NNN, HMPMA, CEMA, 1-OHP, O-toluidine, 2-NA, 4-ABP', 'daily cigarette consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0452249', 'cui_str': 'Mint'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1851549', 'cui_str': 'Benign occipital lobe epilepsy'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butan-1-ol'}, {'cui': 'C0063186', 'cui_str': 'hydroxypropyl methacrylate'}, {'cui': 'C0039654', 'cui_str': '12-O-Tetradecanoyl Phorbol 13-Acetate'}, {'cui': 'C0007061', 'cui_str': 'Carboxyhemoglobin'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0067113', 'cui_str': ""N'-nitrosonornicotine""}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0046584', 'cui_str': '2-aminotoluene'}, {'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}]",279.0,0.0643203,All reductions in JUUL groups were substantially and statistically significantly greater than reductions in the UB Cigarette group (ps<0.025).,"[{'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Cohen', 'Affiliation': 'Juul Labs, Inc., Washington, DC, USA.'}, {'ForeName': 'Nicholas I', 'Initials': 'NI', 'LastName': 'Goldenson', 'Affiliation': 'Juul Labs, Inc., Washington, DC, USA.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Bailey', 'Affiliation': 'Juul Labs, Inc., Washington, DC, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Juul Labs, Inc., Washington, DC, USA.'}, {'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Shiffman', 'Affiliation': 'Pinney Associates, Inc., Pittsburgh, PA, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab134']
724,34170943,"Restrictive versus liberal fluid resuscitation strategy, influence on blood loss and hemostatic parameters in mild obstetric hemorrhage: An open-label randomized controlled trial. (REFILL study).","BACKGROUND


Evidence for optimal hemostatic resuscitation in postpartum hemorrhage (PPH) is lacking. Liberal fluid administration may result in acidosis, hypothermia and coagulopathy.
OBJECTIVE


We hypothesize that in early PPH a restrictive fluid administration results in less progression to moderate PPH.
STUDY DESIGN


In four Dutch hospitals we recruited women of 18 years and over, and more than 24 weeks pregnant. Exclusion criteria were: anticoagulant therapy, known coagulation disorders, pre-eclampsia, antenatal diagnosis of abnormally adhesive placenta, and a contraindication for liberal fluid therapy. We blindly randomized participants at 500 mL and ongoing blood loss in the third stage of labor between restrictive fluid administration (clear fluids 0.75-1.0 times the volume of blood lost) and liberal fluid administration (clear fluids 1.5-2.0 times the volume of blood lost). The primary outcome was progression to more than 1000 mL blood loss. Analyses were according to the intention-to-treat principle.
RESULTS


From August 2014 till September 2019, 5190 women were informed of whom 1622 agreed to participate. A total of 252 women were randomized of which 130 were assigned to the restrictive group and 122 to the liberal group. In the restrictive management group 51 of the 130 patients (39.2%) progressed to more than 1000 mL blood loss versus 61 of the 119 patients (51.3%) in the liberal management group (difference, -12.0% [95%-CI -24.3% to 0.3%], p = 0.057). There was no difference in the need for blood transfusion, coagulation parameters, or in adverse events between the groups.
CONCLUSIONS


Although a restrictive fluid resuscitation in women with mild PPH could not been proven to be superior, it does not increase the need for blood transfusion, alter coagulation parameters, or cause a rise in adverse events. It can be considered as an alternative treatment option to liberal fluid resuscitation.
TRIAL REGISTRATION


NTR3789.",2021,"There was no difference in the need for blood transfusion, coagulation parameters, or in adverse events between the groups.
","['mild obstetric hemorrhage', 'In four Dutch hospitals we recruited women of 18 years and over, and more than 24 weeks pregnant', 'From August 2014 till September 2019, 5190 women were informed of whom 1622 agreed to participate', 'postpartum hemorrhage (PPH', 'A total of 252 women were randomized of which 130 were assigned to the restrictive group and 122 to the liberal group']",[],"['blood loss and hemostatic parameters', 'blood transfusion, coagulation parameters, or in adverse events', 'progression to more than 1000 mL blood loss']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1883310', 'cui_str': '1000'}]",5190.0,0.202469,"There was no difference in the need for blood transfusion, coagulation parameters, or in adverse events between the groups.
","[{'ForeName': 'Pim B B', 'Initials': 'PBB', 'LastName': 'Schol', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Natascha M', 'Initials': 'NM', 'LastName': 'de Lange', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Mallory D', 'Initials': 'MD', 'LastName': 'Woiski', 'Affiliation': 'Department of Obstetrics and Gynecology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Josje', 'Initials': 'J', 'LastName': 'Langenveld', 'Affiliation': 'Department of Obstetrics and Gynecology, Zuyderland, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Luc J M', 'Initials': 'LJM', 'LastName': 'Smits', 'Affiliation': 'Department of Epidemiology, Caphri School for Public Health and Primary Care, Maastricht, The Netherlands.'}, {'ForeName': 'Martine M', 'Initials': 'MM', 'LastName': 'Wassen', 'Affiliation': 'Department of Obstetrics and Gynecology, Zuyderland, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Yvonne M', 'Initials': 'YM', 'LastName': 'Henskens', 'Affiliation': 'Central Diagnostics Laboratory, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Hubertina C J', 'Initials': 'HCJ', 'LastName': 'Scheepers', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0253765']
725,34165763,Thermoregulation During Pregnancy: a Controlled Trial Investigating the Risk of Maternal Hyperthermia During Exercise in the Heat.,"OBJECTIVES


Despite the well-established benefits of exercise, pregnant women are discouraged from physical activity in hot/humid conditions to avoid hyperthermia (core temperature (T core ) ≥ 39.0 °C). Recent epidemiological evidence also demonstrates greater risk of negative birth outcomes following heat exposure during pregnancy, possibly due to thermoregulatory impairments. We aimed to determine (1) the risk of pregnant women exceeding a T core  of 39.0 °C during moderate-intensity exercise in the heat; and (2) if any thermoregulatory impairments are evident in pregnant (P) versus non-pregnant (NP) women.
METHODS


Thirty participants (15 pregnant in their second trimester or third trimester) completed two separate exercise-heat exposures in a climate chamber (32 °C, 45%RH). On separate occasions, each participant cycled on a semi-recumbent cycle ergometer for 45 min at a workload representative of a moderate-intensity (1) non-weight-bearing (NON-WB), or (2) weight-bearing (WB) activity. Thermoregulatory responses were monitored throughout.
RESULTS


The highest rectal temperature observed in a pregnant individual was 37.93 °C. Mean end-exercise rectal temperature did not differ between groups (P:37.53 ± 0.22 °C, NP:37.52 ± 0.34 °C, P = 0.954) in the WB trial, but was lower in the P group (P:37.48 ± 0.25 °C, vs NP:37.73 ± 0.38 °C, P = 0.041) in the NON-WB trial. Whole-body sweat loss was unaltered by pregnancy during WB (P:266 ± 62 g, NP:264 ± 77 g; P = 0.953) and NON-WB P:265 ± 51 g, NP:300 ± 75 g; P = 0.145) exercise. Pregnant participants reported higher ratings of thermal sensation (felt hotter) than their non-pregnant counterparts in the WB trial (P = 0.002) but not in the NON-WB trial, (P = 0.079).
CONCLUSION


Pregnant women can perform 45 min of moderate-intensity exercise at 32 °C, 45%RH with very low apparent risk of excessive maternal hyperthermia. No thermoregulatory impairments with pregnancy were observed.",2021,"Pregnant participants reported higher ratings of thermal sensation (felt hotter) than their non-pregnant counterparts in the WB trial (P = 0.002) but not in the NON-WB trial, (P = 0.079).
","['pregnant women exceeding a T core  of 39.0\xa0°C during moderate-intensity exercise in the heat; and (2) if any thermoregulatory impairments are evident in pregnant (P) versus non-pregnant (NP) women', 'pregnant women', 'Thirty participants (15 pregnant in their second trimester or third trimester) completed two', 'Pregnant women']","['semi-recumbent cycle ergometer for 45\xa0min at a workload representative of a moderate-intensity (1) non-weight-bearing (NON-WB), or (2) weight-bearing (WB) activity', 'separate exercise-heat exposures in a climate chamber']","['Maternal Hyperthermia', 'higher ratings of thermal sensation', 'Thermoregulatory responses', 'highest rectal temperature', 'Mean end-exercise rectal temperature']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0032980', 'cui_str': 'Second trimester pregnancy'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205448', 'cui_str': '2'}]","[{'cui': 'C0444334', 'cui_str': 'Recumbent body position'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0445100', 'cui_str': 'Non-weight-bearing'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0239930', 'cui_str': 'Heat exposure'}, {'cui': 'C0008946', 'cui_str': 'Climate'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",30.0,0.112639,"Pregnant participants reported higher ratings of thermal sensation (felt hotter) than their non-pregnant counterparts in the WB trial (P = 0.002) but not in the NON-WB trial, (P = 0.079).
","[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Smallcombe', 'Affiliation': 'Thermal Ergonomics Laboratory, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Agalyaa', 'Initials': 'A', 'LastName': 'Puhenthirar', 'Affiliation': 'Thermal Ergonomics Laboratory, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Casasola', 'Affiliation': 'Thermal Ergonomics Laboratory, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Daniela S', 'Initials': 'DS', 'LastName': 'Inoue', 'Affiliation': 'Thermal Ergonomics Laboratory, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Georgia K', 'Initials': 'GK', 'LastName': 'Chaseling', 'Affiliation': 'Thermal Ergonomics Laboratory, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ravanelli', 'Affiliation': 'Thermal Ergonomics Laboratory, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'Thermal Ergonomics Laboratory, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Jay', 'Affiliation': 'Thermal Ergonomics Laboratory, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia. Ollie.jay@sydney.edu.au.'}]","Sports medicine (Auckland, N.Z.)",['10.1007/s40279-021-01504-y']
726,34165694,Confirmed 6-Month Disability Improvement and Worsening Correlate with Long-term Disability Outcomes in Alemtuzumab-Treated Patients with Multiple Sclerosis: Post Hoc Analysis of the CARE-MS Studies.,"INTRODUCTION


In the 2-year CARE-MS trials (NCT00530348; NCT00548405) in patients with relapsing-remitting multiple sclerosis, alemtuzumab showed superior efficacy versus subcutaneous interferon beta-1a. Efficacy was maintained in two consecutive extensions (NCT00930553; NCT02255656). This post hoc analysis compared disability outcomes over 9 years among alemtuzumab-treated patients according to whether they experienced confirmed disability improvement (CDI) or worsening (CDW) or neither CDI nor CDW.
METHODS


CARE-MS patients were randomized to receive two alemtuzumab courses (12 mg/day; 5 days at baseline; 3 days at 12 months), with additional as-needed 3-day courses in the extensions. CDI or CDW were defined as ≥ 1.0-point decrease or increase, respectively, in Expanded Disability Status Scale (EDSS) score from core study baseline confirmed over 6 months, assessed in patients with baseline EDSS score ≥ 2.0. Improved or stable EDSS scores were defined as ≥ 1-point decrease or ≤ 0.5-point change (either direction), respectively, from core study baseline. Functional systems (FS) scores were also assessed.
RESULTS


Of 511 eligible patients, 43% experienced CDI and 34% experienced CDW at any time through year 9 (patients experiencing both CDI and CDW were counted in each individual group); 29% experienced neither CDI nor CDW. At year 9, patients with CDI had a -0.58-point mean EDSS score change from baseline; 88% had stable or improved EDSS scores. Improvements occurred across all FS, primarily in sensory, pyramidal, and cerebellar domains. Patients with CDW had a +1.71-point mean EDSS score change; 16% had stable or improved EDSS scores. Patients with neither CDI nor CDW had a -0.10-point mean EDSS score change; 98% had stable or improved EDSS scores.
CONCLUSION


CDI achievement at any point during the CARE-MS studies was associated with improved disability at year 9, highlighting the potential of alemtuzumab to change the multiple sclerosis course. Conversely, CDW at any point was associated with worsened disability at year 9.",2021,"Improvements occurred across all FS, primarily in sensory, pyramidal, and cerebellar domains.",['patients with relapsing-remitting multiple sclerosis'],[],"['6-Month Disability Improvement and Worsening Correlate with Long-term Disability Outcomes', 'worsened disability', 'disability improvement (CDI) or worsening (CDW', 'Functional systems (FS) scores', 'CDW', 'EDSS scores', 'CDI nor CDW', 'disability outcomes', 'stable EDSS scores', 'Efficacy', 'Expanded Disability Status Scale (EDSS) score', 'sensory, pyramidal, and cerebellar domains', 'CDI or CDW']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]",[],"[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",511.0,0.0535114,"Improvements occurred across all FS, primarily in sensory, pyramidal, and cerebellar domains.","[{'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Hunter', 'Affiliation': 'Advanced Neurosciences Institute, 101 Forrest Crossing Blvd., Franklin, TN, 37064, USA. sfhunter@neurosci.us.'}, {'ForeName': 'Rany A', 'Initials': 'RA', 'LastName': 'Aburashed', 'Affiliation': 'Institute for Neurosciences and Multiple Sclerosis, Owosso, MI, USA.'}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Alroughani', 'Affiliation': 'Division of Neurology, Department of Medicine, Amiri Hospital, Sharq, Kuwait.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Department of Neurology, Inselspital Bern, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Dive', 'Affiliation': 'University Hospital Centre of Liège, Liège, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Eichau', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kantor', 'Affiliation': 'Florida Atlantic University, Boca Raton, FL, USA.'}, {'ForeName': 'Ho Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Research Institute and Hospital of National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lycke', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Richard A L', 'Initials': 'RAL', 'LastName': 'Macdonell', 'Affiliation': 'Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pozzilli', 'Affiliation': 'Department of Human Neuroscience, Sapienza University, Rome, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': 'Allegheny General Hospital, Drexel University College of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Sharrack', 'Affiliation': 'Sheffield NIHR Neuroscience BRC and Sheffield Teaching Hospitals, Sheffield, UK.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wiendl', 'Affiliation': 'University of Münster, Münster, Germany.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Chung', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Darren P', 'Initials': 'DP', 'LastName': 'Baker', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': 'Univ. Lille, INSERM U1172 LilNCog, CHU Lille, FHU Precise, Lille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology and therapy,['10.1007/s40120-021-00262-3']
727,34166483,Corrigendum to: Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial.,,2021,,['hospitalized older patients with multi-morbidity and polypharmacy'],[],[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}]",[],[],,0.185536,,"[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""O'Mahony"", 'Affiliation': 'University College Cork School of Medicine-Medicine Cork Ireland, Cork University Hospital Group, Cork, Ireland.'}, {'ForeName': 'Adalsteinn', 'Initials': 'A', 'LastName': 'Gudmundsson', 'Affiliation': 'Landspitali University Hospital Reykjavik, Landspitali, Iceland.'}, {'ForeName': 'Roy L', 'Initials': 'RL', 'LastName': 'Soiza', 'Affiliation': 'NHS Grampian, University of Aberdeen Institute of Applied Health Sciences-Ageing Clinical and Experimental Research, Aberdeen, UK.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Petrovic', 'Affiliation': 'University of Ghent-Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Jose Cruz-Jentoft', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cherubini', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fordham', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'School of Pharmacy, University College Cork, Cork, Ireland.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Dahly', 'Affiliation': 'University College Cork, Cork, Ireland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gallagher', 'Affiliation': 'Cork University Hospital-Geriatric Medicine, Cork, Ireland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lavan', 'Affiliation': 'University College Cork, School of Medicine-Geriatrics, Cork, Ireland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Curtin', 'Affiliation': 'University College Cork, School of Medicine-Geriatrics, Cork, Ireland.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Dalton', 'Affiliation': 'University College Cork, National University of Ireland, Pharmaceutical Care Research Group, School of Pharmacy, Cork Ireland.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Cullinan', 'Affiliation': 'Royal College of Surgeons, School of Pharmacy, Dublin, Ireland.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Flanagan', 'Affiliation': 'University College Cork, Clinical Research Facility, Cork, Ireland.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Shiely', 'Affiliation': 'University College Cork, School of Epidemiology and Public Health, Cork, Ireland.'}, {'ForeName': 'Olafur', 'Initials': 'O', 'LastName': 'Samuelsson', 'Affiliation': 'Landspitali University Hospital, Geriatric Medicine Reykjavik, Iceland.'}, {'ForeName': 'Astros', 'Initials': 'A', 'LastName': 'Sverrisdottir', 'Affiliation': 'Landspitali University Hospital, Geriatric Medicine Reykjavik, Iceland.'}, {'ForeName': 'Selvarani', 'Initials': 'S', 'LastName': 'Subbarayan', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Aberdeen UK.'}, {'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Vandaele', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Meireson', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Montero-Errasquin', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Rexach-Cano', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Correa Perez', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Lozano-Montoya', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Vélez-Díaz-Pallarés', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Cerenzia', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Samanta', 'Initials': 'S', 'LastName': 'Corradi', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Soledad Cotorruelo Ferreiro', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Dimitri', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marinelli', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Martelli', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Fong Soe Khioe', 'Affiliation': 'University of East Anglia, Faculty of Medicine and Health Sciences, Norwich, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eustace', 'Affiliation': 'University College Cork, National University of Ireland-Clinical Research Facility, Cork, Ireland.'}]",Age and ageing,['10.1093/ageing/afab120']
728,34166447,Rationale and study protocol for the Movement Oriented Games Based Assessment (MOGBA) cluster randomized controlled trial: A complex movement skill intervention for 8-12 year old children within 'Made to Play'.,"There is a positive relationship between children's movement competence and physical activity, with a further relationship established between physical activity and childhood obesity. The Movement Oriented Games Based Assessment (MOGBA) is a delivery and assessment intervention designed to improve children's complex movement skills, based on principles of motor development and assessment theories. MOGBA aims to improve children's movement competence, physical fitness and self-perceptions (physical and game) and increase children's moderate-to-vigorous physical activity (MVPA). MOGBA is to be used in the 'Made to Play' initiative, involving 105 sports and activity programs across 21 countries, involving over 25 million children. A multi-site cluster randomized controlled trial will take place across three global sites (UK, Ireland and Australia). Each site will recruit eight primary schools (four experiment, four control) with each school providing two separate classes of children from age ranges 8-12 years (Site n = ~300, total n = 904). After baseline assessments, schools will be randomly allocated to an experimental or wait-list control group. Following two half-day workshops, trained facilitators will deliver the MOGBA intervention for 9 weeks. The main intervention components include delivery of 14 games-based activities with associated assessments of children's movement and differentiation to meet children's needs by manipulating space, effort and relationships. The primary outcome of the trial is to improve children's' movement competence (The Dragon Challenge), with secondary outcomes of improving children's' in-activity and leisure-time MVPA (5-day accelerometer), physical fitness (standing long jump and push ups) and self-perceptions (physical and game). Data will be analysed using multilevel modelling approaches. The MOGBA intervention has been designed to improve children's movement competence and scalable interventions based on MOGBA could be applied across programs within the Made to Play initiative, globally. The trial is registered at the Australia New Zealand Clinical Trial Registry (ACTRN12619001320145p, 27 Sep 2019).",2021,"The Movement Oriented Games Based Assessment (MOGBA) is a delivery and assessment intervention designed to improve children's complex movement skills, based on principles of motor development and assessment theories.","['eight primary schools (four experiment, four control) with each school providing two separate classes of children from age ranges 8-12 years (Site n = ~300, total n = 904', ""8-12 year old children within 'Made to Play""]","['complex movement skill intervention', 'Movement Oriented Games Based Assessment (MOGBA']","[""children's' movement competence (The Dragon Challenge), with secondary outcomes of improving children's' in-activity and leisure-time MVPA (5-day accelerometer), physical fitness (standing long jump and push ups) and self-perceptions (physical and game"", ""children's movement competence, physical fitness and self-perceptions (physical and game) and increase children's moderate-to-vigorous physical activity (MVPA""]","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C4553584', 'cui_str': 'Dragon'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",105.0,0.124574,"The Movement Oriented Games Based Assessment (MOGBA) is a delivery and assessment intervention designed to improve children's complex movement skills, based on principles of motor development and assessment theories.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morley', 'Affiliation': 'Discipline of Sport and Exercise Science, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rudd', 'Affiliation': 'School of Sport and Exercise Sciences, Faculty of Science and Engineering, Liverpool John Moores University, Liverpool, Merseyside, England.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Issartel', 'Affiliation': 'Department of Health and Human Performance, Faculty of Science and Health, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Goodway', 'Affiliation': 'Department of Human Sciences, College of Education and Human Ecology, The Ohio State University, Columbus, Ohio, United States of America.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': ""O'Connor"", 'Affiliation': 'Sydney School of Education and Social Work, Faculty of Arts and Social Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Foulkes', 'Affiliation': 'School of Sport and Exercise Sciences, Faculty of Science and Engineering, Liverpool John Moores University, Liverpool, Merseyside, England.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Babic', 'Affiliation': 'School of Education, Faculty of Education and Arts, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kavanagh', 'Affiliation': 'Department of Health and Human Performance, Faculty of Science and Health, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'School of Education, Faculty of Education and Arts, The University of Newcastle, Callaghan, New South Wales, Australia.'}]",PloS one,['10.1371/journal.pone.0253747']
729,34173229,Telephone follow-up to reduce unplanned hospital returns for older emergency department patients: A randomized trial.,"BACKGROUND/OBJECTIVES


Telephone follow-up calls could optimize the transition from the emergency department (ED) to home for older patients. However, the effects on hospital return rates are not clear. We investigated whether telephone follow-up reduces unplanned hospitalizations and/or unplanned ED return visits within 30 days of ED discharge.
DESIGN


Pragmatic randomized controlled trial with allocation by month; odd months intervention group, even months control group.
SETTING


Two ED locations of a non-academic teaching hospital in The Netherlands.
PARTICIPANTS


Community-dwelling adults aged ≥70 years, discharged home from the ED were randomized to the intervention group (N = 4732) or control group (N = 5104).
INTERVENTION


Intervention group patients: semi-scripted telephone call from an ED nurse within 24 h after discharge to identify post-discharge problems and review discharge instructions. Control group patients: scripted satisfaction survey telephone call.
MEASUREMENTS


Primary outcome: total number of unplanned hospitalizations and/or ED return visits within 30 days of ED discharge.
SECONDARY OUTCOMES


separate numbers of unplanned hospitalizations and ED return visits. Subgroup analysis by age, sex, living condition, and degree of crowding in the ED at discharge.
RESULTS


Overall, 42% were males, and median age was 78 years. In the intervention group, 1516 of 4732 patients (32%) consented, and in the control group 1659 of 5104 (33%) patients. Unplanned 30-day hospitalization and/or ED return visit was found in 16% of intervention group patients and 14% of control group patients (odds ratio 1.16; 95% confidence interval: 0.96-1.42). Also, no statistically significant differences were found in secondary outcome measures. Within the subgroups, the intervention did not have beneficial effects for the intervention group.
CONCLUSION


Telephone follow-up after ED discharge in older patients did not result in reduction of unplanned hospital admissions and/or ED return visits within 30 days. These results raise the question of whether other outcomes could be improved by post-discharge ED telephone follow-up.",2021,Unplanned 30-day hospitalization and/or ED return visit was found in 16% of intervention group patients and 14% of control group patients (odds ratio 1.16; 95% confidence interval: 0.96-1.42).,"['older patients', 'Community-dwelling adults aged ≥70\u2009years, discharged home from the ED', 'older emergency department patients', 'Control group patients', 'Overall, 42% were males, and median age was 78\u2009years', 'Two ED locations of a non-academic teaching hospital in The Netherlands']","['Telephone follow-up', 'Intervention group patients: semi-scripted telephone call from an ED nurse within 24\u2009h after discharge to identify post-discharge problems and review discharge instructions', 'scripted satisfaction survey telephone call']","['hospital return rates', 'unplanned hospital returns', 'Unplanned 30-day hospitalization and/or ED return visit', 'unplanned hospitalizations and ED return visits', 'unplanned hospitalizations and/or unplanned ED return visits', 'unplanned hospital admissions and/or ED return visits', 'total number of unplanned hospitalizations and/or ED return visits within 30\u2009days of ED discharge']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0950282,Unplanned 30-day hospitalization and/or ED return visit was found in 16% of intervention group patients and 14% of control group patients (odds ratio 1.16; 95% confidence interval: 0.96-1.42).,"[{'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'van Loon-van Gaalen', 'Affiliation': 'Emergency Department, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'M Christien', 'Initials': 'MC', 'LastName': 'van der Linden', 'Affiliation': 'Emergency Department, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Department of Internal Medicine, Section of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Roos C', 'Initials': 'RC', 'LastName': 'van der Mast', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.17336']
730,34174128,"A high potency multi-strain probiotic improves glycemic control in children with new-onset type 1 diabetes mellitus: A randomized, double-blind, and placebo-controlled pilot study.","BACKGROUND


Studies in animal models and humans with type 1 diabetes mellitus (T1DM) have shown that probiotic supplementation leads to decreased pro-inflammatory cytokines (responsible for damaging β-cells of the pancreas), improved gut barrier function, and induction of immune tolerance.
OBJECTIVE


To study the effect of supplementation of probiotics in children with T1DM on glycemic control, insulin dose, and plasma C-peptide levels.
METHODS


A single-centered, double-blinded, and randomized placebo-controlled pilot trial was conducted in children (2-12 years) with new-onset T1DM. Ninety-six children were randomized and allocated to Placebo or Intervention groups. The intervention included high dose (112.5 billion viable lyophilized bacteria per capsule) multi-strain probiotic De Simone formulation (manufactured by Danisco-Dupont) sold as Visbiome® in India. The probiotic was supplemented for 3 months and HbA1c, fasting C-peptide, blood sugar records, and insulin dose was recorded at baseline and 3 months.
RESULTS


A total of 90 patients (45 in each group) were analyzed for outcome parameters. We found a significant decrease in HbA1c (5.1 vs. 3.8; p = 0.021) and a significant decline in total and bolus insulin dose (U/kg/day; p = 0.037 and 0.018, respectively) in the intervention group when compared with the placebo group. A significantly higher (p = 0.023) number of children achieved remission in the treatment group. We did not notice adverse effects in either of the study groups.
CONCLUSION


Children with newly diagnosed T1DM managed with standard treatment along with probiotics showed better glycemic control and a decrease in insulin requirements; however, more extensive studies are further warranted.",2021,A significantly higher (p = 0.023) number of children achieved remission in the treatment group.,"['children with new-onset Type 1 diabetes mellitus', 'children with T1DM', 'humans with Type 1 Diabetes Mellitus (T1DM', 'children (2-12\u2009years) with new-onset T1DM', 'Ninety-six children']","['potency multi-strain probiotic', 'Placebo', 'high dose (112.5 billion viable lyophilized bacteria per capsule) multi-strain probiotic product VSL3 (manufactured by Danisco-Dupont) sold as Vivomixx® [MENDES, S.A., Lugano, Switzerland', 'placebo']","['gut barrier function, and induction of immune tolerance', 'total and bolus insulin dose', 'glycemic control', 'insulin requirements', 'HbA1c']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C2742135', 'cui_str': 'SELL protein, human'}, {'cui': 'C0574516', 'cui_str': 'Mende language'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020963', 'cui_str': 'Immunologic tolerance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",96.0,0.272414,A significantly higher (p = 0.023) number of children achieved remission in the treatment group.,"[{'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatrics, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatrics, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Latika', 'Initials': 'L', 'LastName': 'Rohilla', 'Affiliation': 'Department of Pediatrics, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Neenu', 'Initials': 'N', 'LastName': 'Jacob', 'Affiliation': 'Department of Pediatrics, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Jaivinder', 'Initials': 'J', 'LastName': 'Yadav', 'Affiliation': 'Department of Pediatrics, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Sachdeva', 'Affiliation': 'Department of Endocrinology, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",Pediatric diabetes,['10.1111/pedi.13244']
731,34175558,The effects of exercise intensity on the cortisol response to a subsequent acute psychosocial stressor.,"OBJECTIVE


The aim of this experimental study was to determine the extent to which the intensity of a single 30 min bout of exercise alters the salivary cortisol (sCort) response to a subsequently induced acute psychosocial stressor. The study further aimed to elucidate a physiological mechanism through which exercise intensity exerts stress-mitigating effects.
METHODS


Eighty-three healthy men (M age  = 21.04 SD = 2.89) were randomly assigned to exercise on a treadmill at either 30%, 50% or 70% of their heart rate reserve (HRR) for 30 min and then underwent the Trier Social Stress Test 45 min later. sCort was measured repeatedly throughout and following the exercise bout and stressor task.
RESULTS


ANCOVA and Multilevel Growth Curve Analysis determined that vigorous (70% HRR) exercise elicited dampened sCort responses to the stressor task, marked by lower total sCort levels, diminished sCort reactivity, and faster recovery to baseline values, as compared to less intense exercise. Moreover, exercise elicited a sCort response in proportion to the intensity at which it was performed, and this exercise-associated HPA-axis response was inversely proportional to the sCort response to the subsequent stressor task.
CONCLUSIONS


This study revealed that exercise-intensity dampens the HPA-axis stress response in a dose-dependent manner, with evidence that the cortisol released from exercising intensely suppresses the subsequent cortisol response to a psychosocial stressor.",2021,"This study revealed that exercise-intensity dampens the HPA-axis stress response in a dose-dependent manner, with evidence that the cortisol released from exercising intensely suppresses the subsequent cortisol response to a psychosocial stressor.",['Eighty-three healthy men (M age  =\xa021.04 SD\xa0=\xa02.89'],"['exercise on a treadmill at either 30%, 50% or 70% of their heart rate reserve (HRR) for 30\xa0min and then underwent the Trier Social Stress Test 45\xa0min later']","['salivary cortisol (sCort) response', 'HPA-axis stress response', 'total sCort levels, diminished sCort reactivity']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",83.0,0.0173675,"This study revealed that exercise-intensity dampens the HPA-axis stress response in a dose-dependent manner, with evidence that the cortisol released from exercising intensely suppresses the subsequent cortisol response to a psychosocial stressor.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caplin', 'Affiliation': 'School of Kinesiology, University of British Columbia, 210-6081 University Blvd, Vancouver, BC, Canada V6T1Z1.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology, University of British Columbia, 3521-2136 West Mall, Vancouver, BC, Canada V6T1Z4.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'School of Kinesiology, University of British Columbia, 210-6081 University Blvd, Vancouver, BC, Canada V6T1Z1.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Puterman', 'Affiliation': 'School of Kinesiology, University of British Columbia, 210-6081 University Blvd, Vancouver, BC, Canada V6T1Z1. Electronic address: eli.puterman@ubc.ca.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105336']
732,34175554,A randomized trial of race-related stress among African Americans with chronic kidney disease.,"OBJECTIVE


African Americans progress from early to late-stage chronic kidney disease (CKD) at a rate that is three times that of Whites. Given research that implicates social stress in poor kidney outcomes, there is a need to examine whether race-related stress contributes to these disparities. Through experimental manipulation, this study sought to determine whether acute race-related stress was associated with autonomic arousal and an inflammatory marker, which are well-established pathways to poor kidney outcomes. Further we tested the hypothesis that expectations of racism may moderate this relationship.
METHOD


Fifty-two African American patients along the CKD continuum were randomized to recall a general or race-related stressful experience. Before, during, and after the recall, patients' blood pressure and Interleukin-6 (IL-6) were monitored. Prior to the experimental manipulation, participants completed self-reported measures of expectations of racism.
RESULTS


Across both study conditions, change in self-reported distress from baseline to stress was associated with both systolic and diastolic reactivity (both ps <.01), but not change in IL-6 responses (all ps > 0.05). A significant interaction revealed that those who were randomized to recall a race-related stressor demonstrated less diastolic blood pressure reactivity (F=4.80, p<.05) if they scored lower in expectations of racism as compared to those who scored high. Moreover, those who were randomized to the race-related stressor demonstrated greater increase in IL-6 from 45 to 90 min post-recall than those who recalled a general stressor (F=6.35, p<.05).
CONCLUSIONS


Acute race-related stress may be associated with autonomic arousal and inflammatory response among African American patients along the CKD continuum, suggesting the need to further understand its role in racial disparities in CKD progression.",2021,"Across both study conditions, change in self-reported distress from baseline to stress was associated with both systolic and diastolic reactivity (both ps <.01), but not change in IL-6 responses (all ps > 0.05).","['Fifty-two African American patients along the CKD continuum were randomized to recall a general or race-related stressful experience', 'African American patients', 'African Americans with chronic kidney disease']",[],"['IL-6', 'IL-6 responses', 'diastolic blood pressure reactivity', 'systolic and diastolic reactivity', 'blood pressure and Interleukin-6 (IL-6']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",[],"[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",52.0,0.0446598,"Across both study conditions, change in self-reported distress from baseline to stress was associated with both systolic and diastolic reactivity (both ps <.01), but not change in IL-6 responses (all ps > 0.05).","[{'ForeName': 'Kimberly Jacob', 'Initials': 'KJ', 'LastName': 'Arriola', 'Affiliation': 'Rollins School of Public Health of Emory University, United States. Electronic address: kjacoba@emory.edu.'}, {'ForeName': 'Tené T', 'Initials': 'TT', 'LastName': 'Lewis', 'Affiliation': 'Rollins School of Public Health of Emory University, United States.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Pearce', 'Affiliation': 'Rollins School of Public Health of Emory University, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cobb', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Renal Division, United States.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Weldon', 'Affiliation': 'Rollins School of Public Health of Emory University, United States.'}, {'ForeName': 'Madelyn I Zapata', 'Initials': 'MIZ', 'LastName': 'Valentin', 'Affiliation': 'Ponce Health Sciences University, Puerto Rico.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Lea', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Renal Division, United States.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health of Emory University, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105339']
733,34180315,"Comparison of two levonorgestrel-releasing intrauterine systems for the treatment of heavy menstrual bleeding: a randomised, controlled, phase 3 trial.","PURPOSE


To evaluate the levonorgestrel-releasing intrauterine system Donasert ®  (also known as Levosert ® ) compared with the reference product Mirena ®  for the alleviation of heavy menstrual bleeding (HMB).
MATERIALS AND METHODS


A phase 3 multicentre, non-inferiority, active-controlled study in non-menopausal women with HMB (menstrual blood loss [MBL] ≥ 80 mL) as the primary symptom randomised to either Donasert ®  or Mirena ®  and followed for 6 months. MBL was evaluated using a validated, modified version of the Wyatt pictogram.
RESULTS


Overall, 312 were randomised (158 to Donasert ®  and 154 to Mirena ® ). The mean (standard deviation) absolute change in MBL from baseline to 6 months in the per-protocol population ( N  = 300) was -130 (71.8) mL and -127 (67.3) mL in the Donasert ®  and Mirena ®  groups, respectively; non-inferiority of Donasert ®  was confirmed ( p -value <0.0001). Successful treatment of HMB (MBL <80 mL) and a decrease to ≤50% of baseline MBL was achieved in 139/154 (90.3%) and 126/146 (86.3%) participants in the Donasert ®  and Mirena ®  groups, respectively and the between-treatment difference was non-significant. Most adverse events were mild in severity. Only two device expulsions occurred in the study and there were no uterine perforations.
CONCLUSIONS


Donasert ®  has equivalent efficacy and safety during the first 6 months foralleviation of HMB compared to the reference device, Mirena ® .
TRIAL REGISTRATION NUMBER


348 (Clinical Trials Registry of the Ministry of Health of the Russian Federation, http://grls.rosminzdrav.ru/default.aspx).",2021,"Only two device expulsions occurred in the study and there were no uterine perforations.
","['non-menopausal women with HMB (menstrual blood loss [MBL]\u2009≥\u200980\u2009mL', 'heavy menstrual bleeding']","['Donasert ®  or Mirena ®  and followed for 6\u2009months', 'levonorgestrel-releasing intrauterine system Donasert ®', 'levonorgestrel-releasing intrauterine systems']","['mean (standard deviation) absolute change in MBL', 'MBL', 'efficacy and safety', 'baseline MBL']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}]","[{'cui': 'C0591811', 'cui_str': 'Mirena'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.282704,"Only two device expulsions occurred in the study and there were no uterine perforations.
","[{'ForeName': 'Alexey B', 'Initials': 'AB', 'LastName': 'Ilyin', 'Affiliation': 'Federal State Budgetary Institution ""Almazov National Medical Research Centre"" of the Ministry of Health of the Russian Federation, St. Petersburg, Russia.'}, {'ForeName': 'Albir A', 'Initials': 'AA', 'LastName': 'Khasanov', 'Affiliation': 'Kazan State Medical University, Kazan, Russia.'}, {'ForeName': 'Larisa V', 'Initials': 'LV', 'LastName': 'Suturina', 'Affiliation': 'Scientific Center for Family Health and Human Reproduction, Irkutsk, Russia.'}, {'ForeName': 'Natalia I', 'Initials': 'NI', 'LastName': 'Borisova', 'Affiliation': 'University Clinical Hospital #2, Clinic of Obstetrics and Gynecology, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Zakhar S', 'Initials': 'ZS', 'LastName': 'Reshetov', 'Affiliation': 'Medical Research Institute LLC, St. Petersburg, Russia.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Foidart', 'Affiliation': 'University of Liège, Liège, Belgium.'}, {'ForeName': 'Judit Alexandra', 'Initials': 'JA', 'LastName': 'Déri', 'Affiliation': 'Medical Affairs, Gedeon Richter Plc., Budapest, Hungary.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Tóth', 'Affiliation': 'Medical Affairs, Gedeon Richter Plc., Budapest, Hungary.'}]",The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception,['10.1080/13625187.2021.1942447']
734,34176711,Intensified Total Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer: A Phase II Trial.,"AIMS


We assessed the efficacy and safety of total neoadjuvant therapy, including targeted agent plus FOLFOXIRI (5-fluorouracil, leucovorin, oxaliplatin and irinotecan) induction chemotherapy followed by intensified chemoradiotherapy (CRT) and surgical resection, in patients with locally advanced rectal cancer.
MATERIALS AND METHODS


This was a single-arm, single-centre phase II trial. Eligible patients had non-metastatic locally advanced rectal adenocarcinoma. Based on Ras-BRAF status, patients were treated with bevacizumab (mutated Ras-BRAF) or panitumumab/cetuximab (wild-type Ras-BRAF) plus FOLFOXIRI regimen followed by oxaliplatin-5-fluorouracil-based CRT and surgery. The primary end point was pathological complete response rate. Secondary end points were toxicity, compliance, tumour downstaging, complete resection, surgical complications, local and distant failures and overall survival. The sample size was planned to expect an absolute 20% improvement in pathological complete response rate over historical literature data with an α error of 0.05 and a power of 80%.
RESULTS


Between October 2015 and September 2019, 28 patients (median age 66 years) were enrolled. All patients had regional lymph node involvement at diagnosis. FOLFOXIRI plus bevacizumab was administered in 11 mutated Ras-BRAF patients, whereas the 17 wild-type Ras-BRAF patients received FOLFOXIRI plus panitumumab/cetuximab. Overall, total neoadjuvant therapy was well tolerated and 26 patients (92.9%) completed the programmed strategy. A complete response was achieved in nine cases (32.1%) and a nearly pathological complete response (ypT1 ypN0) in two patients (7.2%). There was no evidence of febrile neutropenia and no grade 4 adverse events were recorded. Radical resection was achieved in all cases.
CONCLUSION


FOLFOXIRI plus targeted agent-based induction chemotherapy and intensified CRT before surgery showed promising clinical activity and was well tolerated in locally advanced rectal cancer patients. This phase II trial provides a strong rationale for phase III studies.",2021,A complete response was achieved in nine cases (32.1%) and a nearly pathological complete response (ypT1 ypN0) in two patients (7.2%).,"['patients with locally advanced rectal cancer', 'locally advanced rectal cancer patients', 'Eligible patients had non-metastatic locally advanced rectal adenocarcinoma', '28 patients (median age 66 years) were enrolled', 'All patients had regional lymph node involvement at diagnosis', 'Patients With Locally Advanced Rectal Cancer', 'Between October 2015 and September 2019']","['bevacizumab (mutated Ras-BRAF) or panitumumab/cetuximab', 'FOLFOXIRI plus bevacizumab', 'total neoadjuvant therapy, including targeted agent plus FOLFOXIRI (5-fluorouracil, leucovorin, oxaliplatin and irinotecan) induction chemotherapy followed by intensified chemoradiotherapy (CRT) and surgical resection', 'Intensified Total Neoadjuvant Therapy', 'FOLFOXIRI plus panitumumab/cetuximab', 'oxaliplatin-5-fluorouracil-based CRT and surgery']","['toxicity, compliance, tumour downstaging, complete resection, surgical complications, local and distant failures and overall survival', 'efficacy and safety', 'febrile neutropenia and no grade 4 adverse events', 'pathological complete response rate', 'Radical resection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1269796', 'cui_str': 'pN category'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",11.0,0.0701301,A complete response was achieved in nine cases (32.1%) and a nearly pathological complete response (ypT1 ypN0) in two patients (7.2%).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'De Felice', 'Affiliation': 'Department of Radiotherapy, Policlinico Umberto I ""Sapienza"" University of Rome, Rome, Italy. Electronic address: fradefelice@hotmail.it.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': ""D'Ambrosio"", 'Affiliation': 'Department of General Surgery, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Iafrate', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gelibter', 'Affiliation': 'Medical Oncology Department, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Magliocca', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Musio', 'Affiliation': 'Department of Radiotherapy, Policlinico Umberto I ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Caponetto', 'Affiliation': 'Medical Oncology Department, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Casella', 'Affiliation': 'Department of General Surgery, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Clementi', 'Affiliation': 'Department of General Surgery, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Picchetto', 'Affiliation': 'Department of General Surgery, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sirgiovani', 'Affiliation': 'Medical Oncology Department, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Parisi', 'Affiliation': 'Department of Radiotherapy, Policlinico Umberto I ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Orciuoli', 'Affiliation': 'Medical Oncology Department, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Torrese', 'Affiliation': 'Department of Radiotherapy, Policlinico Umberto I ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'De Toma', 'Affiliation': 'Department of General Surgery, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Tombolini', 'Affiliation': 'Department of Radiotherapy, Policlinico Umberto I ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cortesi', 'Affiliation': 'Medical Oncology Department, Policlinico Umberto I, ""Sapienza"" University of Rome, Rome, Italy.'}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2021.06.006']
735,34184312,Randomized controlled trial of a quadratus lumborum block with liposomal bupivacaine for postoperative analgesia in laparoscopic donor nephrectomy.,"Perioperative pain management is an important consideration in early recovery and patient satisfaction following laparoscopic donor nephrectomy. Transmuscular quadratus lumborum block has been described to reduce pain and opioid usage following several abdominal surgeries. In this prospective single-blind randomized controlled trial, we compared 52 patients who adhered to our institutional donor nephrectomy Early Recovery After Surgery pathway, which includes a laparoscopic-guided transversus abdominus plane block, to 40 patients who additionally received a transmuscular quadratus lumborum block with liposomal bupivacaine. Compared to control patients, those who received the block spent longer in the operating room prior to the surgical start (65.4 vs. 51.6 min, P < .001). Both groups had similar total hospital length of stay (33.3 h vs. 34.4 h, P = .61). Pain scores from postoperative days 0-30, number of patients requiring opioids, postoperative nausea, and pain management satisfaction were similar between both groups. Patients who received the block consumed less opioid on postoperative day 1 compared to controls (P = .006). No complications were attributable to the block. The quadratus lumborum block provides a safe pain management adjunct for some patients, and may reduce opioid use in the early postoperative period when combined with our standard institutional protocol for kidney donors.",2021,Patients who received the block consumed less opioid on post-operative day 1 compared to controls (p = 0.006).,"['laparoscopic donor nephrectomy', '52 patients who adhered to our institutional donor nephrectomy Early Recovery']","['laparoscopic-guided transversus abdominus plane block', 'laparoscopic donor nephrectomy', 'transmuscular quadratus lumborum block with liposomal bupivacaine', 'quadratus lumborum block with liposomal bupivacaine']","['number of patients requiring opioids, post-operative nausea, and pain management satisfaction', 'Pain scores', 'total hospital length of stay']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",52.0,0.178264,Patients who received the block consumed less opioid on post-operative day 1 compared to controls (p = 0.006).,"[{'ForeName': 'Hans Albin', 'Initials': 'HA', 'LastName': 'Gritsch', 'Affiliation': 'Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Osbun', 'Affiliation': 'Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Grogan', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Fero', 'Affiliation': 'Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Partownavid', 'Affiliation': 'Department of Anesthesiology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Stockman', 'Affiliation': 'Department of Anesthesiology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Namjeh', 'Initials': 'N', 'LastName': 'Sadoughi', 'Affiliation': 'Department of Anesthesiology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Blumberg', 'Affiliation': 'Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McDonald', 'Affiliation': 'Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Cowan', 'Affiliation': 'Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Anesthesiology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}]",Clinical transplantation,['10.1111/ctr.14403']
736,34193961,"Treatment of mixed depression with theta-burst stimulation (TBS): results from a double-blind, randomized, sham-controlled clinical trial.","Mixed depression is probably different in terms of clinical course and response to treatment. Repetitive transcranial magnetic stimulation (rTMS) is well established in non-mixed depression, and theta-burst stimulation (TBS) protocol is replacing conventional protocols because of noninferiority and reduced delivery time. However, TBS has not been adequately studied in mixed states. This study was a double-blind, six-week, sham-controlled, and randomized clinical trial of bilateral TBS targeting the right and left dorsolateral prefrontal cortex, respectively. Adults with bipolar and major depressive disorder experiencing an acute mixed depression were eligible if they had not benefited from a first- or second-line treatment for acute unipolar or bipolar depression recommended by the Canadian Network for Mood and Anxiety Treatments. Out of 100 patients included, 90 composed modified intention-to-treat sample, which was patients that completed at least one week of the intervention. There were no significant differences in Montgomery-Asberg depression rating scale score changes (least squares mean difference between groups at week 3, -0.06 [95% CI, - 3.39 to 3.51; P = 0.97] in favor of sham TBS). Response and remission rates per MADRS were also not statistically different among active and sham groups (35.7% vs. 43.7%, and 28.5% vs. 37.5% respectively at week 6, ps > 0.51). No other analyses from baseline to weeks 3 or 6 revealed significant time x group interaction or mean differences among groups in the mITT sample. Bilateral TBS targeting the DLPFC is not efficacious as an add-on treatment of acute bipolar and unipolar mixed depression. ClinicalTrials.govIdentifier: NCT04123301.",2021,"There were no significant differences in Montgomery-Asberg depression rating scale score changes (least squares mean difference between groups at week 3, -0.06","['Adults with bipolar and major depressive disorder experiencing an acute mixed depression were eligible if they had not benefited from a first- or second-line treatment for acute unipolar or bipolar depression recommended by the Canadian Network for Mood and Anxiety Treatments', '100 patients included, 90 composed modified intention-to-treat sample, which was patients that completed at least one week of the intervention']","['bilateral TBS', 'TBS', 'Repetitive transcranial magnetic stimulation (rTMS', 'mixed depression with theta-burst stimulation (TBS', 'ClinicalTrials.govIdentifier']","['Montgomery-Asberg depression rating scale score changes', 'Response and remission rates per MADRS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0558208', 'cui_str': 'Anxiety about treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",100.0,0.498589,"There were no significant differences in Montgomery-Asberg depression rating scale score changes (least squares mean difference between groups at week 3, -0.06","[{'ForeName': 'Diego Freitas', 'Initials': 'DF', 'LastName': 'Tavares', 'Affiliation': 'Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Suen', 'Affiliation': 'Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Carla Garcia', 'Initials': 'CG', 'LastName': 'Rodrigues Dos Santos', 'Affiliation': 'Mood Disorders Unit, Department and Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Doris Hupfeld', 'Initials': 'DH', 'LastName': 'Moreno', 'Affiliation': 'Mood Disorders Unit, Department and Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Leandro Da Costa', 'Initials': 'LDC', 'LastName': 'Lane Valiengo', 'Affiliation': 'Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Izio', 'Initials': 'I', 'LastName': 'Klein', 'Affiliation': 'Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Borrione', 'Affiliation': 'Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Marques Forte', 'Affiliation': 'Mood Disorders Unit, Department and Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'André R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil. brunoni@usp.br.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Alberto Moreno', 'Affiliation': 'Mood Disorders Unit, Department and Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01080-9']
737,34161146,Phase II Trial of Flaxseed to Prevent Acute Complications After Chemoradiation for Lung Cancer.,"Background:  Thoracic radiotherapy is complicated by acute radiation-induced adverse events such as radiation pneumonitis (RP) and radiation esophagitis (RE). Based on preclinical work and a randomized pilot trial from our laboratory, this single-arm phase II trial investigated administering flaxseed as a radioprotector in patients receiving definitive chemoradiation for nonsmall cell lung cancer (NSCLC).  Methods:  Between June 2015 and February 2018, 33 patients with locally advanced or metastatic NSCLC with planned definitive chemoradiation were enrolled. Finely-ground  Linum usitatissimum L.  (Linaceae; flaxseed or linseed) in 40-g packets were provided for daily consumption in any patient-desired formulation 1 week before radiotherapy and throughout radiotherapy as tolerated. The primary outcomes were overall adverse events, with particular focus on Grade ≥3 RP, and flaxseed tolerability. Adverse events were graded according to CTCAE v4.0.  Results:  Of the 33 patients enrolled, 5 patients (15%) did not receive chemoradiation, 4 (12%) withdrew promptly after enrollment, 4 (12%) did not return a flaxseed consumption log, and 1 patient had irritable bowel syndrome (3%). The remaining 19 patients (57%) had chemoradiation and flaxseed ingestion with a mean completion and standard deviation of the intended flaxseed course of 62% ± 8.3%. Nine (50%) of these 19 patients reported difficulties with flaxseed consumption, citing nausea, constipation, odynophagia, or poor taste or texture. One patient (5%), with unverifiable flaxseed consumption, developed Grade 3 RP. There were no cases of Grade 2 RP. Six patients (32%) developed Grade 2 RE, but no patients developed Grade ≥3 RE. Median overall and progression-free survival were 31 and 12 months, respectively.  Conclusions:  Despite the low incidence of acute radiation-induced complications reported, significant treatment-related gastrointestinal toxicities and subsequently low flaxseed tolerability inhibit accurate determination of flaxseed effect in patients receiving concurrent thoracic chemoradiation. Thus, further investigations should focus on optimizing flaxseed formulation for improved tolerability and evaluation. ClinicalTrials.gov ID: NCT02475330.",2021,There were no cases of Grade 2 RP.,"['Lung Cancer', 'patients receiving definitive chemoradiation for nonsmall cell lung cancer (NSCLC', 'patients receiving concurrent thoracic chemoradiation', 'Methods:  Between June 2015 and February 2018, 33 patients with locally advanced or metastatic NSCLC with planned definitive chemoradiation were enrolled']","['radioprotector', 'Thoracic radiotherapy']","['Acute Complications', 'gastrointestinal toxicities', 'Adverse events', 'Grade ≥3 RE', 'irritable bowel syndrome', 'Grade 2 RE', 'Median overall and progression-free survival', 'overall adverse events, with particular focus on Grade ≥3 RP, and flaxseed tolerability', 'difficulties with flaxseed consumption, citing nausea, constipation, odynophagia, or poor taste or texture']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0221150', 'cui_str': 'Swallowing painful'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0449582', 'cui_str': 'With texture'}]",33.0,0.266389,There were no cases of Grade 2 RP.,"[{'ForeName': 'Tristan L', 'Initials': 'TL', 'LastName': 'Lim', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Ralph A', 'Initials': 'RA', 'LastName': 'Pietrofesa', 'Affiliation': 'Pulmonary, Allergy, and Critical Care Division, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Evguenia', 'Initials': 'E', 'LastName': 'Arguiri', 'Affiliation': 'Pulmonary, Allergy, and Critical Care Division, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Constantinos', 'Initials': 'C', 'LastName': 'Koumenis', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Feigenberg', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Simone', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Rengan', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Cengel', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Levin', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Melpo', 'Initials': 'M', 'LastName': 'Christofidou-Solomidou', 'Affiliation': 'Pulmonary, Allergy, and Critical Care Division, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Abigail T', 'Initials': 'AT', 'LastName': 'Berman', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0542']
738,34167891,Neurophysiological effects of repetitive transcranial magnetic stimulation (rTMS) in treatment resistant depression.,"OBJECTIVE


Repetitive transcranial magnetic stimulation (rTMS) is effective for treatment resistant depression (TRD), but little is known about rTMS' effects on neurophysiological markers. We previously identified neurophysiological markers in depression (N45 and N100) of GABA receptor mediated inhibition. Here, we indexed TMS-electroencephalographic (TMS-EEG) effects of rTMS.
METHODS


TMS-EEG data was analyzed from a double blind 2:1 randomized active (10 Hz left/bilateral):sham rTMS TRD trial. Participants underwent TMS-EEG over left dorsolateral prefrontal cortex (DLPFC) before and after 6 weeks of rTMS. 30 had useable datasets. TMS-evoked potentials (TEP) and components (N45, N100, P60) were examined with global mean field analysis (GMFA) and locally in DLPFC regions of interest.
RESULTS


The N45 amplitude differed between active and sham groups over time, N100 amplitude did not. N45 (t = 2.975, p = 0.007) and N100 amplitudes (t = 2.177, p = 0.042) decreased after active rTMS, demonstrating alterations in cortical inhibition. TEP amplitudes decreased after active rTMS in left (t = 4.887, p < 0.001) and right DLPFC (t = 4.403, p < 0.001) not sham rTMS, demonstrating alterations in cortical excitability.
CONCLUSIONS


Our results provide important new knowledge regarding rTMS effects on TMS-EEG measures in TRD, suggesting rTMS reduces neurophysiological markers of inhibition and excitability.
SIGNIFICANCE


These findings uncover potentially important neurophysiological mechanisms of rTMS action.",2021,"TEP amplitudes decreased after active rTMS in left (t = 4.887, p < 0.001) and right DLPFC (t = 4.403, p < 0.001) not sham rTMS, demonstrating alterations in cortical excitability.
",[],"['Repetitive transcranial magnetic stimulation (rTMS', 'TMS-EEG', 'repetitive transcranial magnetic stimulation (rTMS']","['cortical excitability', 'right DLPFC', 'TEP amplitudes', 'TMS-evoked potentials (TEP) and components (N45, N100, P60']",[],"[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0444779', 'cui_str': 'N100 (N1)'}, {'cui': 'C1137054', 'cui_str': 'SQSTM1 protein, human'}]",,0.0295754,"TEP amplitudes decreased after active rTMS in left (t = 4.887, p < 0.001) and right DLPFC (t = 4.403, p < 0.001) not sham rTMS, demonstrating alterations in cortical excitability.
","[{'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nigel C', 'Initials': 'NC', 'LastName': 'Rogasch', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Alfred and Monash University Central Clinical School, Victoria, Australia.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Faranak', 'Initials': 'F', 'LastName': 'Farzan', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Foussias', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, United States. Electronic address: zdaskalakis@health.ucsd.edu.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2021.05.008']
739,34175270,Traditional vs Extended Hybrid Cardiac Rehabilitation Based on the Continuous Care Model for Patients Who Have Undergone Coronary Artery Bypass Surgery in a Middle-Income Country: A Randomized Controlled Trial.,"OBJECTIVE


To compare traditional (1-month supervised) vs hybrid cardiac rehabilitation (CR; usual care) with an additional 3 months offered remotely based on the continuous care model (intervention) in patients who have undergone coronary artery bypass graft (CABG).
DESIGN


Randomized controlled trial, with blinded outcome assessment.
SETTING


A major heart center in a middle-income country.
PARTICIPANTS


Of 107 eligible patients who were referred to CR during the period of study, 82.2% (N=88) were enrolled (target sample size). Participants were randomly assigned 1:1 (concealed; 44 per parallel arm). There was 92.0% retention.
INTERVENTIONS


After CR, participants were given a mobile application and communicated biweekly with the nurse from months 1-4 to control risk factors.
MAIN OUTCOME MEASURES


Quality of life (QOL, Short Form-36, primary outcome); functional capacity (treadmill test); and the Depression, Anxiety and Stress Scale were evaluated pre-CR, after 1 month, and 3 months after CR (end of intervention), as well as rehospitalization.
RESULTS


The analysis of variance interaction effects for the physical and mental component summary scores of QOL were <.001, favoring intervention (per protocol); there were also significant increases from pre-CR to 1 month, and from 1 month to the final assessment in the intervention arm (P<.001), with change in the control arm only to 1 month. The effect sizes were 0.115 and 0.248, respectively. Similarly, the interaction effect for functional capacity was significant (P<.001), with a clinically significant 1.5 metabolic equivalent of task increase in the intervention arm. There were trends for group effects for the psychosocial indicators, with paired t tests revealing significant increases in each at both assessment points in the intervention arm. At 4 months, there were 4 (10.3%) rehospitalizations in the control arm and none in intervention (P=.049). Intended theoretical mechanisms were also affected by the intervention.
CONCLUSIONS


Extending CR in this accessible manner, rendering it more comprehensive, was effective in improving outcomes.",2021,"The analysis of variance interaction effects for the physical and mental component summary scores of QoL were <.001, favoring intervention (per protocol); there were also significant increases from pre-CR to 1 month, and from 1 month to the final assessment in the intervention arm (p-values<.001), with change in the control arm only to 1 month.","['Of 107 eligible patients that were referred to CR during the period of study, 88 (82.2%) were enrolled (target sample size', 'A major heart center in a middle-income country', 'coronary artery bypass surgery patients in a middle-income country']","['hybrid cardiac rehabilitation (CR; usual care) with an additional 3 months offered remotely based on the continuous care model (CCM; intervention', 'Traditional versus extended hybrid cardiac rehabilitation', 'coronary artery bypass graft (CABG) patients']","['Quality of life (QoL; SF-36; primary outcome), functional capacity (treadmill test), depression, anxiety and stress (DASS-21', 're-hospitalizations', 'functional capacity']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",107.0,0.0400796,"The analysis of variance interaction effects for the physical and mental component summary scores of QoL were <.001, favoring intervention (per protocol); there were also significant increases from pre-CR to 1 month, and from 1 month to the final assessment in the intervention arm (p-values<.001), with change in the control arm only to 1 month.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Pakrad', 'Affiliation': 'Department of Nursing, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Fazlollah', 'Initials': 'F', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Nursing, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. Electronic address: Ahmadif@modares.ac.ir.'}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Grace', 'Affiliation': 'Faculty of Health, York University, Toronto, Canada; KITE- Toronto Rehabilitation Institute, Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Khodayar', 'Initials': 'K', 'LastName': 'Oshvandi', 'Affiliation': 'Chronic Disease (Home Care) Research Center, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Anoshirvan', 'Initials': 'A', 'LastName': 'Kazemnejad', 'Affiliation': 'Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.04.026']
740,34180331,Health-related quality of life outcomes from the CANDOR study in patients with relapsed or refractory multiple myeloma.,"CANDOR (NCT03158688) compared carfilzomib, dexamethasone, and daratumumab (KdD) to carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM). A secondary objective of CANDOR was to evaluate health-related quality of life (HRQoL) scores using the Global Health Status (GHS)/Quality of Life (QoL) domain of the EORTC QLQ-C30. Scores were compared between KdD and Kd using a restricted maximum likelihood-based mixed effects model for repeated measures. GHS/QoL completion rates were >81% for both arms. Higher GHS/QoL scores were observed with KdD versus Kd from Cycle 7-26. The overall least squares mean estimate (95% CI) of the difference between treatment arms was 0.06 (-2.39 to 2.50;  p  = 0.96). In an exploratory analysis, 55.5% in the KdD arm and 43.0% in the Kd arm improved ≥10 points in GHS/QoL score from baseline. HRQoL was maintained with KdD, consistent with superior clinical benefit observed with KdD versus Kd in patients with RRMM.",2021,scores using the Global Health Status (GHS)/Quality of Life (QoL) domain of the EORTC QLQ-C30.,"['patients with relapsed or refractory multiple myeloma', 'patients with relapsed/refractory multiple myeloma (RRMM', 'patients with RRMM']","['carfilzomib, dexamethasone, and daratumumab (KdD) to carfilzomib and dexamethasone (Kd']","['Higher GHS/QoL scores', 'GHS/QoL completion rates', 'GHS/QoL score', 'HRQoL', 'health-related quality of life (HRQoL', 'Global Health Status (GHS)/Quality of Life (QoL) domain of the EORTC QLQ-C30']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.106508,scores using the Global Health Status (GHS)/Quality of Life (QoL) domain of the EORTC QLQ-C30.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Siegel', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Zahlten-Kumeli', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Medhekar', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Bifeng', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'CHU de Poitiers - La Miletrie, Poitiers, France.'}]",Leukemia & lymphoma,['10.1080/10428194.2021.1941927']
741,34177805,Effectiveness of a Yoga-Based Lifestyle Protocol (YLP) in Preventing Diabetes in a High-Risk Indian Cohort: A Multicenter Cluster-Randomized Controlled Trial (NMB-Trial).,"Introduction


Though several lines of evidence support the utility of yoga-based interventions in diabetes prevention, most of these studies have been limited by methodological issues, primarily sample size inadequacy. Hence, we tested the effectiveness of yoga-based lifestyle intervention against diabetes risk reduction in multicentre, large community settings of India, through a single-blind cluster-randomized controlled trial, Niyantrita Madhumeha Bharat Abhiyan (NMB).
Research Design and Methods


NMB-trial is a multicentre cluster-randomized trial conducted in 80 clusters [composed of rural units (villages) and urban units (Census Enumeration Blocks)] randomly assigned in a 1:1 ratio to intervention and control groups. Participants were individuals (age, 20-70 years) with prediabetes (blood HbA1c values in the range of 5.7-6.4%) and IDRS ≥ 60. The intervention included the practice of yoga-based lifestyle modification protocol (YLP) for 9 consecutive days, followed by daily home and weekly supervised practices for 3 months. The control cluster received standard of care advice for diabetes prevention. Statistical analyses were performed on an intention-to-treat basis, using available and imputed datasets. The primary outcome was the conversion from prediabetes to diabetes after the YLP intervention of 3 months (diagnosed based upon HbA1c cutoff >6.5%). Secondary outcome included regression to normoglycemia with HbA1c <5.7%.
Results


A total of 3380 (75.96%) participants were followed up at 3 months. At 3 months post-intervention, overall, diabetes developed in 726 (21.44%) participants. YLP was found to be significantly effective in halting progression to diabetes as compared to standard of care; adjusted RRR was 63.81(95% CI = 56.55-69.85). The YLP also accelerated regression to normoglycemia [adjusted Odds Ratio ( adj OR) = 1.20 (95% CI, 1.02-1.43)]. Importantly, younger participants (≤40 years) were found to regress to normoglycemia more effectively than the older participants P interaction <0.001.
Conclusion


Based on the significant risk reduction derived from the large sample size, and the carefully designed randomized yoga-based intervention on high-risk populations, the study is a preliminary but strong proof-of-concept for yoga as a potential lifestyle-based treatment to curb the epidemic of diabetes. The observed findings also indicate a potential of YLP for diabetes prevention in low/moderate risk profile individuals that needs large-scale validation.
Trial Registration


Clinical Trial Registration Number: CTRI/2018/03/012804.",2021,YLP was found to be significantly effective in halting progression to diabetes as compared to standard of care; adjusted RRR was 63.81(95% CI = 56.55-69.85).,"['80 clusters [composed of rural units (villages) and urban units (Census Enumeration Blocks', 'Diabetes in a High-Risk Indian Cohort', 'Participants were individuals (age, 20-70 years) with prediabetes (blood HbA1c values in the range of 5.7-6.4%) and IDRS ≥ 60']","['standard of care advice for diabetes prevention', 'yoga-based lifestyle intervention', 'yoga-based lifestyle modification protocol (YLP', 'Yoga-Based Lifestyle Protocol (YLP', 'YLP']","['conversion from prediabetes to diabetes', 'regression to normoglycemia with HbA1c <5.7']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0007663', 'cui_str': 'Census'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517822', 'cui_str': '6.4'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517795', 'cui_str': '5.7'}]",3380.0,0.346563,YLP was found to be significantly effective in halting progression to diabetes as compared to standard of care; adjusted RRR was 63.81(95% CI = 56.55-69.85).,"[{'ForeName': 'Nagarathna', 'Initials': 'N', 'LastName': 'Raghuram', 'Affiliation': 'Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India.'}, {'ForeName': 'Venkat', 'Initials': 'V', 'LastName': 'Ram', 'Affiliation': 'Apollo Medical College, Hyderabad, India.'}, {'ForeName': 'Vijaya', 'Initials': 'V', 'LastName': 'Majumdar', 'Affiliation': 'Division of Life Sciences, Swami Vivekananda Yoga University, Bengaluru, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Sk', 'Affiliation': 'Division of Life Sciences, Swami Vivekananda Yoga University, Bengaluru, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Division of Life Sciences, Swami Vivekananda Yoga University, Bengaluru, India.'}, {'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Division of Life Sciences, Swami Vivekananda Yoga University, Bengaluru, India.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Neuroscience Research Lab, Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Ilavarasu', 'Initials': 'I', 'LastName': 'Judu', 'Affiliation': 'Division of Life Sciences, Swami Vivekananda Yoga University, Bengaluru, India.'}, {'ForeName': 'Srikanta', 'Initials': 'S', 'LastName': 'Bhaskara', 'Affiliation': 'Ekisaan Foundation, Bengaluru, India.'}, {'ForeName': 'Jagannadha Rao', 'Initials': 'JR', 'LastName': 'Basa', 'Affiliation': 'International School of Engineering, Hyderabad, India.'}, {'ForeName': 'Hongasandra Ramarao', 'Initials': 'HR', 'LastName': 'Nagendra', 'Affiliation': 'Division of Life Sciences, Swami Vivekananda Yoga University, Bengaluru, India.'}]",Frontiers in endocrinology,['10.3389/fendo.2021.664657']
742,34189869,Characterization of response to atezolizumab + bevacizumab versus sorafenib for hepatocellular carcinoma: Results from the IMbrave150 trial.,"BACKGROUND


IMbrave150 is a phase III trial that assessed atezolizumab + bevacizumab (ATEZO/BEV) versus sorafenib (SOR) in patients with unresectable hepatocellular carcinoma (HCC) and demonstrated a significant improvement in clinical outcomes. Exploratory analyses characterized objective response rate (ORR), depth (DpR), and duration of response (DoR), and patients with a complete response (CR).
METHODS


Patients were randomized 2:1 to intravenous ATEZO (1200 mg) + BEV (15 mg/kg) every 3 weeks or oral SOR (400 mg) twice daily. Tumors were evaluated using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and HCC-modified RECIST (mRECIST). ORR by prior treatment and largest baseline liver lesion size, DoR, time to response (TTR), and complete response (TTCR) were analyzed.
RESULTS


For both criteria, responses favored ATEZO/BEV versus SOR regardless of prior treatment and in patients with lesions ≥3 cm. Median TTR was 2.8 months per RECIST 1.1 (range: 1.2-12.3 months) and 2.8 months per mRECIST (range: 1.1-12.3 months) with ATEZO/BEV. Patients receiving ATEZO/BEV had a greater DpR, per both criteria, across baseline liver lesion sizes. Characteristics of complete responders were similar to those of the intent-to-treat population. In complete responders receiving ATEZO/BEV per mRECIST versus RECIST 1.1, respectively, median TTCR was shorter (5.5 vs. 7.0 months), mean baseline sum of lesion diameter was longer (5.0 [SD, 5.1] vs. 2.6 [SD, 1.4] cm), and mean largest liver lesion size was larger (4.8 [SD, 4.2] vs. 2.3 [SD, 1.0] cm).
CONCLUSIONS


These data highlight the improved ORR, DpR, and CR rates with ATEZO/BEV in unresectable HCC.",2021,"Patients receiving ATEZO/BEV had a greater DpR, per both criteria, across baseline liver lesion sizes.","['Patients', 'patients with unresectable hepatocellular carcinoma (HCC', 'hepatocellular carcinoma']","['intravenous ATEZO (1200\xa0mg)\xa0+\xa0BEV', 'atezolizumab\xa0+\xa0bevacizumab (ATEZO/BEV) versus sorafenib (SOR', 'oral SOR', 'atezolizumab\xa0+\xa0bevacizumab versus sorafenib']","['median TTCR', 'Median TTR', 'ORR by prior treatment and largest baseline liver lesion size, DoR, time to response (TTR), and complete response (TTCR', 'ORR, DpR, and CR rates', 'mean largest liver lesion size', 'objective response rate (ORR), depth (DpR), and duration of response (DoR), and patients with a complete response (CR', 'mean baseline sum of lesion diameter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0406778', 'cui_str': 'Dermatopathia pigmentosa reticularis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019209', 'cui_str': 'Large liver'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",,0.0712152,"Patients receiving ATEZO/BEV had a greater DpR, per both criteria, across baseline liver lesion sizes.","[{'ForeName': 'Riad', 'Initials': 'R', 'LastName': 'Salem', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Daneng', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte, CA, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Sommer', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Sairy', 'Initials': 'S', 'LastName': 'Hernandez', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Verret', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Beiying', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Lencioni', 'Affiliation': 'Department of Radiology, University of Pisa School of Medicine, Pisa, Italy.'}]",Cancer medicine,['10.1002/cam4.4090']
743,34185723,Effects of Local Anesthetic Volume (Standard Versus Low) on Incidence of Hemidiaphragmatic Paralysis and Analgesic Quality for Ultrasound-Guided Superior Trunk Block After Arthroscopic Shoulder Surgery.,"BACKGROUND


Relative to interscalene block, superior trunk block (STB) provides comparable analgesia and a reduced risk of hemidiaphragmatic paralysis. However, the incidence of hemidiaphragmatic paralysis remains high when a standard volume (15 mL) of local anesthetic is used. This study aimed to evaluate the effects of local anesthetic volume of STB on the incidence of phrenic nerve palsy, as well as its analgesic efficacy following arthroscopic shoulder surgery.
METHODS


Patients scheduled for elective arthroscopic shoulder surgery were randomized to receive ultrasound-guided STB using either 5- or 15-mL 0.5% ropivacaine before general anesthesia. The primary outcome was the incidence of hemidiaphragmatic paralysis at 30 minutes after block. The secondary outcomes were pulmonary function, grade of sensory and motor blockade, pain score, opioid consumption, adverse effects, and satisfaction.
RESULTS


Relative to standard-volume STB, low-volume STB was associated with a lower incidence of hemidiaphragmatic paralysis after block (14.3 [4.8%-30.3%] vs 65.7 [46.8%-80.9%]; difference 51.4% [95% confidence intervals {CIs}, 29.0%-67.1%]; P < .0001) and at the postanesthesia care unit (9.4% vs 50.0%; difference 40.6 [95% CI, 18.9%-57.7%]; P = .0004). Pulmonary function was also better preserved in the low-volume group than in the standard-volume group. The extent of the sensory and motor blocks was significantly different between the groups. Pain-related outcomes, satisfaction, and any adverse events were not significantly different between the groups.
CONCLUSIONS


Low-volume STB provided a lower incidence of hemidiaphragmatic paralysis with no significant difference in analgesic efficacy relative to standard-volume STB for arthroscopic shoulder surgery.",2021,"Pain-related outcomes, satisfaction, and any adverse events were not significantly different between the groups.
",['Patients scheduled for elective arthroscopic shoulder surgery'],"['interscalene block, superior trunk block (STB', 'STB', 'ultrasound-guided STB using either 5- or 15-mL 0.5% ropivacaine', 'Local Anesthetic Volume (Standard Versus Low']","['sensory and motor blocks', 'analgesic efficacy', 'pulmonary function, grade of sensory and motor blockade, pain score, opioid consumption, adverse effects, and satisfaction', 'Pulmonary function', 'Incidence of Hemidiaphragmatic Paralysis and Analgesic Quality', 'incidence of hemidiaphragmatic paralysis', 'hemidiaphragmatic paralysis', 'Pain-related outcomes, satisfaction, and any adverse events']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}]","[{'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.152253,"Pain-related outcomes, satisfaction, and any adverse events were not significantly different between the groups.
","[{'ForeName': 'Hyunzu', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Inha University Hospital, Incheon, South Korea.'}, {'ForeName': 'Jeong Uk', 'Initials': 'JU', 'LastName': 'Han', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Inha University Hospital, Incheon, South Korea.'}, {'ForeName': 'Woojoo', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Science, Graduate School of Public Health, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Yoon Sang', 'Initials': 'YS', 'LastName': 'Jeon', 'Affiliation': 'Department of Orthopedic Surgery, Inha University Hospital, Incheon, South Korea.'}, {'ForeName': 'Jimyeong', 'Initials': 'J', 'LastName': 'Jeong', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Inha University Hospital, Incheon, South Korea.'}, {'ForeName': 'Chunwoo', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Inha University Hospital, Incheon, South Korea.'}, {'ForeName': 'Jae Woung', 'Initials': 'JW', 'LastName': 'Uhm', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Inha University Hospital, Incheon, South Korea.'}, {'ForeName': 'Youngjun', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Inha University Hospital, Incheon, South Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005654']
744,34191259,"Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial.","BACKGROUND


Elderly patients are at high-risk of bleeding, but are under-represented in clinical trials.
OBJECTIVES


The aims were to determine the incidence and the predictive factors of bleeding and to assess the impact of bleeding on further ischemic outcomes in elderly patients after acute coronary syndrome (ACS) treated with percutaneous coronary intervention.
METHODS


From the 877 patients aged ≥ 75 years included in the ANTARCTIC randomized trial, data on Bleeding Academic Research Consortium (BARC) bleeding complications and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, myocardial infarction, and stroke, were collected over 1 year.
RESULTS


Clinically relevant bleeding events (BARC types 2, 3, or 5) were observed in 20.6% of patients (n = 181) at 1 year, of which, one third occurred in the first month. Anemia (adjusted hazard ratio [adj.HR] 3.98, 95% confidence interval [CI] 1.41-11.22; p = 0.009), severe chronic renal failure (adj.HR 1.83, 95% CI 1.12-2.98; p = 0.015), and femoral access (adj.HR 2.54, 95% CI 1.71-3.77; p < 0.001) were independently associated with clinically relevant bleeding events, while age > 85 years (adj.HR 2.22, 95% CI 1.14-4.30; p = 0.018) was independently associated with major bleeding events (BARC types 3 or 5). Patients with a clinically relevant bleeding event had a higher rate of MACE at 1 year (adj.HR 2.04, 95% CI 1.24-3.38; p = 0.005), with a particularly strong effect on stroke (adj.HR 5.55, 95% CI 2.04-15.06; p < 0.001).
CONCLUSIONS


Clinically relevant bleeding events were observed in one out of five elderly patients undergoing stenting for an ACS and were strongly associated with further stroke occurrence. Rather than the antiplatelet therapy, comorbidities and an age > 85 years predicted bleeding outcomes in this elderly population.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT01538446. https://www.clinicaltrials.gov .",2021,"Clinically relevant bleeding events (BARC types 2, 3, or 5) were observed in 20.6% of patients (n = ","['elderly patients after acute coronary syndrome (ACS) treated with percutaneous coronary intervention', '75\xa0years', 'Elderly patients', '877 patients aged ≥']",['HR'],"['Bleeding Academic Research Consortium (BARC) bleeding complications and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, myocardial infarction, and stroke', 'bleeding outcomes', 'major bleeding events', 'femoral access', 'Anemia', 'severe chronic renal failure', 'clinically relevant bleeding events', 'Clinically relevant bleeding events', 'bleeding events']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]",5.0,0.308941,"Clinically relevant bleeding events (BARC types 2, 3, or 5) were observed in 20.6% of patients (n = ","[{'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': ""ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'ACTION Study Group, Cardiology Department, Nîmes University Hospital, Montpellier University, Nîmes, France.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': ""ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': 'ACTION Study Group, Cardiology Department, INSERM UMR1062, INRA UMR1260, Centre Hospitalier Universitaire La Timone, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Leclercq', 'Affiliation': 'Cardiology Department, Centre Hospitalier Universitaire de Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Manzo-Silberman', 'Affiliation': 'Cardiology Department, Centre Hospitalier Universitaire Lariboisière (AP-HP), INSERM UMRS 942, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Saint-Etienne', 'Affiliation': 'Cardiology Department, Centre Hospitalier Universitaire de Tours, Tours, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Delarche', 'Affiliation': 'Cardiology Department, Hôpital Francois Mitterrand, Pau, France.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'El Mahmoud', 'Affiliation': 'Cardiology Department, Hôpital Ambroise Paré, Boulogne-Billancourt, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': 'Cardiology Department, Centre Hospitalier Universitaire Rangueil, Université Paul Sabatier Toulouse 3, Toulouse, France.'}, {'ForeName': 'Géraud', 'Initials': 'G', 'LastName': 'Souteyrand', 'Affiliation': 'Cardiology Department, Centre Hospitalier Universitaire Gabriel Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Kerneis', 'Affiliation': ""ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': ""ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': ""ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': ""ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'Abdourahmane', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'ACTION Study Group, Epidemiology and Clinic Research Unit, Lariboisiere University Hospital, Paris, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': ""ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'ACTION Study Group, Epidemiology and Clinic Research Unit, Lariboisiere University Hospital, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': ""ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France. gilles.montalescot@aphp.fr.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-021-00468-8']
745,34172505,Effect of a phone reminder system on patient-centered tuberculosis treatment adherence among adults in Northwest Ethiopia: a randomised controlled trial.,"OBJECTIVES


This study aimed to evaluate the effect of the phone reminder system on patient-centred TB treatment adherence during continuation phase, where patients are responsible for taking medication at home.
METHODS


We conducted a two-arm randomised controlled trial on adult patients with TB during the continuation phase. In the intervention arm, patients received routine care plus phone-based weekly pill refilling and daily medication reminders. In the control arm, participants received only routine care. A covariate adaptive randomisation technique was used to balance covariates during allocation. The primary outcome was adherence to patient-centred TB treatment, and secondary outcomes included provider-patient relationship and treatment outcomes. We applied per-protocol and intention-to-treat analysis techniques.
RESULTS


We randomised 306 patients to intervention (n=152) and control (n=154) groups. Adherence to patient-centred TB treatment was 79% (110/139) in intervention and 66.4% (95/143) in control groups, with relative risk (RR) (95% lower CI) (RR=1.632 (1.162 to ∞); p=0.018, one tailed). Good provider-patient relationship was 73.3% (102/139) in intervention group and 52.4% (75/143) in control group, p=0.0001. TB treatment success was 89.5% (136/152) in intervention group and 85.1% (131/154) in control group, p=0.1238.
CONCLUSIONS


Mobile phone-based weekly refilling with daily medication reminder system improved adherence to patient-centred TB treatment and provider-patient relationship; however, there was no significant effect on treatment success.
TRIAL REGISTRATION NUMBER


Pan African Clinical Trials Registry (PACTR201901552202539).",2021,"CONCLUSIONS


Mobile phone-based weekly refilling with daily medication reminder system improved adherence to patient-centred TB treatment and provider-patient relationship; however, there was no significant effect on treatment success.
","['adult patients with TB during the continuation phase', 'patient-centered tuberculosis treatment adherence among adults in Northwest Ethiopia', '306 patients to intervention (n=152) and control (n=154) groups']","['phone reminder system', 'routine care plus phone-based weekly pill refilling and daily medication reminders']","['TB treatment success', 'adherence to patient-centred TB treatment, and secondary outcomes included provider-patient relationship and treatment outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0085519', 'cui_str': 'Reminder Systems'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",306.0,0.26436,"CONCLUSIONS


Mobile phone-based weekly refilling with daily medication reminder system improved adherence to patient-centred TB treatment and provider-patient relationship; however, there was no significant effect on treatment success.
","[{'ForeName': 'Kassahun Dessie', 'Initials': 'KD', 'LastName': 'Gashu', 'Affiliation': 'Department of Health Informatics, Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia kassahundessie@gmail.com.'}, {'ForeName': 'Kassahun Alemu', 'Initials': 'KA', 'LastName': 'Gelaye', 'Affiliation': 'Department of Epidemiology and Biostatistics, Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lester', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Binyam', 'Initials': 'B', 'LastName': 'Tilahun', 'Affiliation': 'Department of Health Informatics, Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}]",BMJ health & care informatics,['10.1136/bmjhci-2020-100268']
746,34171466,"Clinical efficacy of ultrasound guided bilateral erector spinae block for single-level lumbar fusion surgery: a prospective, randomized, case-control study.","BACKGROUND CONTEXT


Postoperative experience plays a vital role in patient recovery and does not depend on the type and quality of the surgical procedure alone. Non-opioid therapies have become part of the multimodal analgesic regimen for better pain control and reduced opioid-related side effects. Most recently evolved among these are the regional anesthetic techniques, such as the thoracolumbar interfascial plane (TLIP) block and the erector spinae (ESP) block.
PURPOSE


To assess the efficacy of ultrasound-guided (US) ESP block for postoperative analgesia after a single level lumbar spine fusion surgery compared with conventional (opioid-based) multimodal postoperative analgesia.
STUDY DESIGN


A prospective, randomized, controlled, and double-blinded clinical trial.
PATIENT SAMPLE


A 100 consecutive patients requiring single-level lumbar spinal fusion procedure were randomized into two groups- block (multimodal analgesia with US-ESP) and control (only multimodal analgesia) groups.
OUTCOME MEASURES


Demographic and surgical data, intra-operative blood loss, duration of surgery, total opioid consumption (TOC) and amount of muscle relaxants used were assessed. Postoperatively, the Numeric pain Rating Scale(NRS), Modified Observer's assessment of Alertness and/or Sedation Scale (MOASS) and Patient satisfaction scores were recorded every 2 hours for the first 6 hours followed by every 6 hours for 24 hours. Continuous variables were analyzed using Student's t-test, and categorical variables were analyzed using either the Chi-square test or Fisher's exact test. p-value < .05 was considered statistically significant.
METHODS


Patients in both groups underwent the identical protocol for pre-emptive analgesia and induction of anesthesia. Patients in the block group received the US-ESP block after induction and positioning, followed by the multimodal analgesia, while the control group received only the multimodal analgesia.
RESULTS


Both groups had identical demographic backgrounds and surgical profile. TOC for 24 hours following induction was significantly lower in the block group than the control group (105.0 ± 15.15 vs 158.00 ± 23.38mcg; p < .001). The total muscle relaxant consumption during surgery was also significantly less in the block group than the control group (51.90 ± 3.17 vs 57.70 ± 5.90; p < .001). The intra-operative blood loss was significantly less (p < .001) in the block group (303.00 ± 86.55 ml) than the control group (437.00 ± 116.85 ml). Compared to the block group, the control group's pain score (NRS) was significantly higher in the first 48 hours following surgery. The MOASS score was significantly lower in the control group (4.46 ± 0.50 vs 3.82 ± 0.82; p < .001) in the immediate postoperative period. The satisfaction score was significantly higher in the block group than the control group (9.52 ± 0.65 vs 8.22 ± 0.79; p < .001).
CONCLUSION


The employed US-ESP block for single-level lumbar fusion surgery is an effective component of multimodal analgesia for reducing blood loss, total opioid consumption, and related side effects with a significant reduction of postoperative pain and higher patient satisfaction.",2021,The intra-operative blood loss was significantly less (p < 0.001) in the block group (303.00 ± 86.55 ml) than the control group (437.00 ± 116.85 ml).,"['Patients in both groups underwent the', '100 consecutive patients requiring single-level lumbar spinal fusion procedure', 'single level lumbar fusion surgery']","['identical protocol for pre-emptive analgesia and induction of anesthesia', 'ultrasound guided bilateral erector spinae block', 'ultrasound-guided(US) ESP block', 'groups- block (multimodal analgesia with US-ESP) and control (only multimodal analgesia', 'multimodal analgesia', 'US-ESP block', 'conventional (opioid-based) multimodal postoperative analgesia']","['TOC', 'pain score (NRS', ""Numeric pain Rating Scale(NRS), Modified Observer's assessment of Alertness/ Sedation Scale (MOASS) and Patient satisfaction scores"", 'total muscle relaxant consumption', 'satisfaction score', 'blood loss, total opioid consumption', 'Demographic and surgical data, intra-operative blood loss, duration of surgery, total opioid consumption (TOC) and amount of muscle relaxants', 'intra-operative blood loss', 'MOASS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",100.0,0.102061,The intra-operative blood loss was significantly less (p < 0.001) in the block group (303.00 ± 86.55 ml) than the control group (437.00 ± 116.85 ml).,"[{'ForeName': 'Vipin Kumar', 'Initials': 'VK', 'LastName': 'Goel', 'Affiliation': 'Department of Anaesthesia, Ganga Medical Center and Hospitals Pvt. Ltd., Mettupalayam Road, Coimbatore, India.'}, {'ForeName': 'Madhanmohan', 'Initials': 'M', 'LastName': 'Chandramohan', 'Affiliation': 'Department of Anaesthesia, Ganga Medical Center and Hospitals Pvt. Ltd., Mettupalayam Road, Coimbatore, India.'}, {'ForeName': 'Chandhan', 'Initials': 'C', 'LastName': 'Murugan', 'Affiliation': 'Department of Spine Surgery, Ganga Medical Center and Hospitals Pvt. Ltd., Mettupalayam Road, Coimbatore, India.'}, {'ForeName': 'Ajoy Prasad', 'Initials': 'AP', 'LastName': 'Shetty', 'Affiliation': 'Department of Spine Surgery, Ganga Medical Center and Hospitals Pvt. Ltd., Mettupalayam Road, Coimbatore, India. Electronic address: ajoyshetty@gmail.com.'}, {'ForeName': 'Balavenkat', 'Initials': 'B', 'LastName': 'Subramanian', 'Affiliation': 'Department of Anaesthesia, Ganga Medical Center and Hospitals Pvt. Ltd., Mettupalayam Road, Coimbatore, India.'}, {'ForeName': 'Rishi Mugesh', 'Initials': 'RM', 'LastName': 'Kanna', 'Affiliation': 'Department of Spine Surgery, Ganga Medical Center and Hospitals Pvt. Ltd., Mettupalayam Road, Coimbatore, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rajasekaran', 'Affiliation': 'Department of Spine Surgery, Ganga Medical Center and Hospitals Pvt. Ltd., Mettupalayam Road, Coimbatore, India.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2021.06.015']
747,34175782,Instagram Sexualization: When posts make you feel dissatisfied and wanting to change your body.,"Instagram is a visually centered social media that involves the presence of sexualized imagery posted by users. Such Instagram sexualization may have a negative impact on women's body image. The present study examined whether exposure to Instagram sexualization, namely posts of sexualized women along with appearance-related comments, affected women's body satisfaction and cosmetic surgery intentions. In doing so, it also considered the moderating role of Instagram Addiction Proclivity (IAP). Young Italian female participants (N = 247) were randomly exposed to one of four video conditions resulting from the combination of either sexualized or non-sexualized women's pictures on Instagram, paired with appearance or neutral comments. In the sexualized picture condition participants' body dissatisfaction increased compared to pre-exposure levels and to the non-sexualized picture condition. The type of comments did not affect participants' body satisfaction. Moreover, IAP predicted cosmetic surgery intentions and moderated their reactions to Instagram content. Indeed, the higher the IAP, the higher the cosmetic surgery intentions of participants viewing sexualized pictures with neutral comments and non-sexualized pictures with body appearance comments. These findings suggest that female Instagram users should be aware of the negative impacts of viewing sexualized imagery as well as the role that IAP may play.",2021,In the sexualized picture condition participants' body dissatisfaction increased compared to pre-exposure levels and to the non-sexualized picture condition.,"['female Instagram users', 'Young Italian female participants (N = 247']","[""sexualized or non-sexualized women's pictures on Instagram, paired with appearance or neutral comments"", 'Instagram Sexualization']","['body dissatisfaction', 'cosmetic surgery intentions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0079169', 'cui_str': 'Cosmetic Surgery'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",247.0,0.0211608,In the sexualized picture condition participants' body dissatisfaction increased compared to pre-exposure levels and to the non-sexualized picture condition.,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Guizzo', 'Affiliation': 'University of Surrey, School of Psychology, Stag Hill Campus, GU2 7HX, Guildford, United Kingdom; University of Padova, Department of Developmental and Social Psychology, Via Venezia 8, 35131, Padova, Italy. Electronic address: f.guizzo@surrey.ac.uk.'}, {'ForeName': 'Natale', 'Initials': 'N', 'LastName': 'Canale', 'Affiliation': 'University of Padova, Department of Developmental and Social Psychology, Via Venezia 8, 35131, Padova, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Fasoli', 'Affiliation': 'University of Surrey, School of Psychology, Stag Hill Campus, GU2 7HX, Guildford, United Kingdom; Centro de Investigação e Intervenção Social do Instituto Universitário de Lisboa, ISCTE-IUL, Av. das Forças Armadas, 1649-026, Lisboa, Portugal.'}]",Body image,['10.1016/j.bodyim.2021.06.005']
748,34176020,Long-term improvement of quality of life in patients with breast cancer: supporting patient-physician communication by an electronic tool for inpatient and outpatient care.,"PURPOSE


The effectiveness of a pathway with quality of life (QoL) diagnosis and therapy has been already demonstrated in an earlier randomized trial (RCT) in patients with breast cancer. We refined the pathway by developing and evaluating an electronic tool for QoL assessment in routine inpatient and outpatient care.
METHODS


In a single-arm study, patients with breast cancer with surgical treatment in two German hospitals were enrolled. QoL (EORTC QLQ-C30, QLQ-BR23) was measured with an electronic tool after surgery and during aftercare in outpatient medical practices (3, 6, 9, 12, 18, and 24 months) so that results (QoL-profile) were available immediately. Feedback by patients and physicians was analyzed to evaluate feasibility and impact on patient-physician communication.
RESULTS


Between May 2016 and July 2018, 56 patients were enrolled. Physicians evaluated the QoL pathway as feasible. Patients whose physician regularly discussed QoL-profiles with them reported significantly more often that their specific needs were cared for (p < .001) and that their physician had found the right treatment strategy for these needs (p < .001) compared with patients whose doctor never/rarely discussed QoL-profiles. The latter significantly more often had no benefit from QoL assessments (p < .001).
CONCLUSION


The QoL pathway with electronic QoL assessments is feasible for inpatient and outpatient care. QoL results should be discussed directly with the patient.
CLINICAL TRIAL INFORMATION


NCT04334096, date of registration 06.04.2020.",2021,"The latter significantly more often had no benefit from QoL assessments (p < .001).
","['patients with breast cancer with surgical treatment in two German hospitals were enrolled', 'Between May 2016 and July 2018, 56 patients were enrolled', 'patients with breast cancer']",['pathway with quality of life (QoL) diagnosis and therapy'],"['QoL (EORTC QLQ-C30, QLQ-BR23', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C4759659', 'cui_str': 'With quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",56.0,0.0499314,"The latter significantly more often had no benefit from QoL assessments (p < .001).
","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lindberg-Scharf', 'Affiliation': 'Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg, Am Biopark 9, 93053, Regensburg, Germany. patricia.lindberg-scharf@ur.de.'}, {'ForeName': 'Brunhilde', 'Initials': 'B', 'LastName': 'Steinger', 'Affiliation': 'Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg, Am Biopark 9, 93053, Regensburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koller', 'Affiliation': 'Center for Clinical Studies, University Hospital Regensburg, Franz-Josef-Strauß-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hofstädter', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Regensburg, St. Hedwig Clinic, Steinmetzstraße 1-3, 93049, Regensburg, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Ortmann', 'Affiliation': 'Department of Gynecology and Obstetrics, University Medical Center Regensburg, Landshuter Straße 65, 93053, RegensburgRegensburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kurz', 'Affiliation': 'Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg, Am Biopark 9, 93053, Regensburg, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sasse', 'Affiliation': 'Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg, Am Biopark 9, 93053, Regensburg, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Klinkhammer-Schalke', 'Affiliation': 'Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg, Am Biopark 9, 93053, Regensburg, Germany.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-021-06270-1']
749,34183568,"Effects of Aerobic Exercise on Cognitive Function in Women With Methamphetamine Dependence in a Detoxification Program in Tianjin, China: A Randomized Controlled Trial.","BACKGROUND


Cognitive impairment is prevalent among individuals, especially women, with methamphetamine dependence. Although aerobic exercise has been shown to affect cognitive function in humans and animals, few related studies have focused on subjects with methamphetamine dependence.
PURPOSE


The aim of this study was to assess the detoxification-related effects of aerobic exercise on cognitive function in women with methamphetamine dependence.
METHODS


A randomized controlled trial was used with 98 women with methamphetamine dependence undergoing a detoxification program at a mental hospital. The women were distributed using a computer-generated grouping random method into either the study or control group. The investigator conducting the baseline questionnaire, the neuropsychologist assessing the cognitive function, and the data analyst were blinded to group assignment. In addition to hospital routine care, the study group received an aerobic exercise intervention for 3 months. The control group only received hospital routine care. Attention and working memory were measured using the Trail Making Test and Digit Span Test, verbal memory was measured using Logical Memory (LM) and Memory for Persons Data (MPD), and executive function was measured using the Color-Word Stroop Test.
RESULTS


Forty-nine participants were randomized into each group, and the valid data of 43 participants in the study group and 46 in the control group were analyzed. The study group showed significantly more improvement over time in terms of Digit Span Test, Trail Making Test, LM-delayed, MPD-5 minutes delayed, MPD-30 minutes delayed, and Color-Word Stroop Test than the control group (p < .05). LM-immediate and MPD-immediate scores showed that the effects of time and the interaction between time and group were significant but that the main effect of group was not.
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


Women undergoing detoxification for methamphetamine dependence may practice aerobic exercise to improve attention, working memory, executive function, and parts of verbal memory. Aerobic exercise may be incorporated into detoxification treatment programs to facilitate the recovery of cognitive functions in women.",2021,"The study group showed significantly more improvement over time in terms of Digit Span Test, Trail Making Test, LM-delayed, MPD-5 minutes delayed, MPD-30 minutes delayed, and Color-Word Stroop Test than the control group (p < .05).","['women', 'Women With Methamphetamine Dependence in a Detoxification Program in Tianjin, China', 'Forty-nine participants', 'individuals, especially women, with methamphetamine dependence', 'subjects with methamphetamine dependence', '98 women with methamphetamine dependence undergoing a detoxification program at a mental hospital', 'women with methamphetamine dependence']","['aerobic exercise intervention', 'aerobic exercise', 'Aerobic Exercise', 'hospital routine care', 'Aerobic exercise']","['cognitive function', 'Cognitive Function', 'Trail Making Test and Digit Span Test, verbal memory', 'Logical Memory (LM) and Memory for Persons Data (MPD), and executive function', 'Digit Span Test, Trail Making Test, LM-delayed, MPD-5 minutes delayed, MPD-30 minutes delayed, and Color-Word Stroop Test', 'Attention and working memory', 'LM-immediate and MPD-immediate scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",98.0,0.0806526,"The study group showed significantly more improvement over time in terms of Digit Span Test, Trail Making Test, LM-delayed, MPD-5 minutes delayed, MPD-30 minutes delayed, and Color-Word Stroop Test than the control group (p < .05).","[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'BSN, RN, Graduate Student, School of Nursing, Tianjin Medical University, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'BSN, RN, Graduate Student, School of Nursing, Tianjin Medical University, China.'}, {'ForeName': 'Maojie', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'BSN, RN, Graduate Student, School of Nursing, Tianjin Medical University, China.'}, {'ForeName': 'Shumei', 'Initials': 'S', 'LastName': 'Zhuang', 'Affiliation': 'PhD, RN, Associate Professor, School of Nursing, Tianjin Medical University, China.'}]",The journal of nursing research : JNR,['10.1097/JNR.0000000000000440']
750,34183510,"Efficacy and Safety of Nonantibiotic Outpatient Treatment in Mild Acute Diverticulitis (DINAMO-study): A Multicentre, Randomised, Open-label, Noninferiority Trial.","OBJECTIVE


Mild AD can be treated safely and effectively on an outpatient basis without antibiotics.
SUMMARY OF BACKGROUND DATA


In recent years, it has shown no benefit of antibiotics in the treatment of uncomplicated AD in hospitalized patients. Also, outpatient treatment of uncomplicated AD has been shown to be safe and effective.
METHODS


A Prospective, multicentre, open-label, noninferiority, randomized controlled trial, in 15 hospitals of patients consulting the emergency department with symptoms compatible with AD.The Participants were patients with mild AD diagnosed by Computed Tomography meeting the inclusion criteria were randomly assigned to control arm (ATB-Group): classical treatment (875/125 mg/8 h amoxicillin/clavulanic acid apart from anti-inflammatory and symptomatic treatment) or experimental arm (Non-ATB-Group): experimental treatment (antiinflammatory and symptomatic treatment). Clinical controls were performed at 2, 7, 30, and 90 days.The primary endpoint was hospital admission. Secondary endpoints included number of emergency department revisits, pain control and emergency surgery in the different arms.
RESULTS


Four hundred and eighty patients meeting the inclusion criteria were randomly assigned to Non-ATB-Group (n = 242) or ATB-Group (n = 238). Hospitalization rates were: ATB-Group 14/238 (5.8%) and Non-ATB-Group 8/242 (3.3%) [mean difference 2.58%, 95% confidence interval (CI) 6.32 to -1.17], confirming noninferiority margin. Revisits: ATB-Group 16/238 (6.7%) and Non-ATB-Group 17/242 (7%) (mean difference -0.3, 95% CI 4.22 to -4.83). Poor pain control at 2 days follow up: ATB-Group 13/230 (5.7%), Non-ATB-Group 5/221 (2.3%) (mean difference 3.39, 95% CI 6.96 to -0.18).
CONCLUSIONS


Nonantibiotic outpatient treatment of mild AD is safe and effective and is not inferior to current standard treatment.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02785549); EU Clinical Trials Register (2016-001596-75).",2021,"Poor pain control at 2 days follow up: ATB-Group 13/230 (5.7%), Non-ATB-Group 5/221 (2.3%) (mean difference 3.39, 95% CI 6.96 to -0.18).
","['hospitalized patients', 'Four hundred and eighty patients meeting the inclusion criteria', 'Participants were patients with mild AD diagnosed by Computed Tomography meeting the inclusion criteria', '15 hospitals of patients consulting the emergency department with symptoms compatible with AD.The', 'Mild Acute Diverticulitis (DINAMO-study']","['control arm (ATB-Group): classical treatment (875/125', 'amoxicillin/clavulanic acid', 'Antibiotic Outpatient Treatment']","['hospital admission', 'Efficacy and Safety', 'Hospitalization rates', 'number of emergency department revisits, pain control and emergency surgery in the different arms', 'Poor pain control']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0518989', 'cui_str': 'Acute diverticulitis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0048072', 'cui_str': '4-anisyltetrazolium blue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0008917', 'cui_str': 'Clavulanic Acids'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}]","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",480.0,0.253503,"Poor pain control at 2 days follow up: ATB-Group 13/230 (5.7%), Non-ATB-Group 5/221 (2.3%) (mean difference 3.39, 95% CI 6.96 to -0.18).
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mora-López', 'Affiliation': ""Coloproctology Unit. Parc Tauli University Hospital, Sabadell. Institut d'investigació i innovació Parc Tauli I3PT. Despartment of Surgery, Universitat Autonoma de Barcelona, Spain.""}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Ruiz-Edo', 'Affiliation': ""Coloproctology Unit. Parc Tauli University Hospital, Sabadell. Institut d'investigació i innovació Parc Tauli I3PT. Despartment of Surgery, Universitat Autonoma de Barcelona, Spain.""}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Estrada-Ferrer', 'Affiliation': 'Coloproctology Unit, Mataro Hospital.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Piñana-Campón', 'Affiliation': 'Department of Surgery, Hospital Universitari Sant Joan de Reus.'}, {'ForeName': 'Meritxell', 'Initials': 'M', 'LastName': 'Labró-Ciurans', 'Affiliation': 'Department of Surgery, Hospital Sant Joan de Déu de Manresa.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Escuder-Perez', 'Affiliation': 'Coloproctology Unit, Joan XXIII University Hospital (Tarragona).'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Sales-Mallafré', 'Affiliation': 'Hospital de Sant Pau i Santa Tecla.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Rebasa-Cladera', 'Affiliation': ""Coloproctology Unit. Parc Tauli University Hospital, Sabadell. Institut d'investigació i innovació Parc Tauli I3PT. Despartment of Surgery, Universitat Autonoma de Barcelona, Spain.""}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Navarro-Soto', 'Affiliation': ""Coloproctology Unit. Parc Tauli University Hospital, Sabadell. Institut d'investigació i innovació Parc Tauli I3PT. Despartment of Surgery, Universitat Autonoma de Barcelona, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Serra-Aracil', 'Affiliation': ""Coloproctology Unit. Parc Tauli University Hospital, Sabadell. Institut d'investigació i innovació Parc Tauli I3PT. Despartment of Surgery, Universitat Autonoma de Barcelona, Spain.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000005031']
751,34391194,A soft baby carrier intervention enhances amygdala responses to infant crying in fathers: A randomized controlled trial.,"New fathers may grow into their parental role through active involvement in childcare. Spending time in physical contact with the child may promote an adaptive transition to fatherhood. In this randomized controlled trial, we tested the effects of a baby carrier intervention on fathers' hormonal and neural functioning. Using functional magnetic resonance imaging (fMRI), we examined whether infant carrying affects neural reactivity to infant crying in first-time fathers, taking into account the role of the hormone oxytocin as a mediating mechanism and fathers' own childhood experiences as a potential moderating factor. Sixty first-time fathers (infant age M = 11.18 weeks, SD = 2.08) were randomly assigned to a baby carrier intervention group (n = 32 fathers) or a control group (n = 28 fathers). Fathers in the intervention group were instructed to use a baby carrier for three weeks, whereas fathers in the control group were instructed to use a baby seat. Before and after the intervention salivary oxytocin was measured and neural reactivity to infant crying was assessed using fMRI. Results showed that the infant carrier intervention increased amygdala reactivity to infant crying compared to the infant seat users. This effect was most pronounced in fathers with experiences of childhood abuse. The carrier intervention did not affect fathers' oxytocin levels. Our findings indicate that spending time in physical contact with the infant may promote attention to and accurate perception of infant signals, in particular in fathers with more adverse childhood experiences. Soft baby carriers may, therefore, facilitate an adaptive transition to fatherhood.",2021,The carrier intervention did not affect fathers' oxytocin levels.,"['infant crying in fathers', 'fathers with experiences of childhood abuse', ""fathers' hormonal and neural functioning"", 'Sixty first-time fathers (infant age M\xa0=\xa011.18 weeks, SD\xa0=\xa02.08']","['baby carrier intervention', 'functional magnetic resonance imaging (fMRI', 'hormone oxytocin', 'soft baby carrier intervention']","['neural reactivity to infant crying', ""fathers' oxytocin levels"", 'amygdala reactivity to infant crying']","[{'cui': 'C0581876', 'cui_str': 'Crying infant'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0221134', 'cui_str': 'Blood group antigen M'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517626', 'cui_str': '2.08'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205358', 'cui_str': 'Soft'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0581876', 'cui_str': 'Crying infant'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}]",,0.0917428,The carrier intervention did not affect fathers' oxytocin levels.,"[{'ForeName': 'Madelon M E', 'Initials': 'MME', 'LastName': 'Riem', 'Affiliation': 'Behavioural Science Institute, Radboud University, The Netherlands; Clinical Child & Family Studies, Faculty of Behavioral and Movement Sciences, Vrije Universiteit, Amsterdam, The Netherlands. Electronic address: Madelon.hendricx-riem@ru.nl.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Lotz', 'Affiliation': 'Clinical Child & Family Studies, Faculty of Behavioral and Movement Sciences, Vrije Universiteit, Amsterdam, The Netherlands; Leiden Institute for Brain and Cognition, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Lisa I', 'Initials': 'LI', 'LastName': 'Horstman', 'Affiliation': 'Clinical Child & Family Studies, Faculty of Behavioral and Movement Sciences, Vrije Universiteit, Amsterdam, The Netherlands; Leiden Institute for Brain and Cognition, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Cima', 'Affiliation': 'Behavioural Science Institute, Radboud University, The Netherlands.'}, {'ForeName': 'Martine W F T', 'Initials': 'MWFT', 'LastName': 'Verhees', 'Affiliation': 'Clinical Child & Family Studies, Faculty of Behavioral and Movement Sciences, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Alyousefi-van Dijk', 'Affiliation': 'Clinical Child & Family Studies, Faculty of Behavioral and Movement Sciences, Vrije Universiteit, Amsterdam, The Netherlands; Leiden Institute for Brain and Cognition, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Marinus H', 'Initials': 'MH', 'LastName': 'van IJzendoorn', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus University Rotterdam, The Netherlands; Research Department of Clinical, Educational and Health Psychology, Faculty of Brain Sciences, UCL, University of London, UK.'}, {'ForeName': 'Marian J', 'Initials': 'MJ', 'LastName': 'Bakermans-Kranenburg', 'Affiliation': 'Clinical Child & Family Studies, Faculty of Behavioral and Movement Sciences, Vrije Universiteit, Amsterdam, The Netherlands.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105380']
752,34189703,"Effects of Recombinant Human Angiotensin-Converting Enzyme 2 on Response to Acute Hypoxia and Exercise: A Randomised, Placebo-Controlled Study.","INTRODUCTION


Angiotensin-converting enzyme 2 (ACE2) is a key enzyme of the renin-angiotensin system (RAS) that has been implicated in the pathogenesis of acute respiratory distress syndrome (ARDS). Enhancing ACE2 activity using GSK2586881, a recombinant form of human ACE2, could be beneficial in diseases such as ARDS but may blunt the hypoxic pulmonary vasoconstriction (HPV) response and potentially impact systemic and tissue oxygenation. This study aimed to evaluate the effect of GSK2586881 0.8 mg/kg on HPV response in healthy adult volunteers during exercise under hypoxic conditions.
METHODS


In this phase I, randomised, double-blind (sponsor open) study, GSK2586881 or placebo was administered as a single intravenous (IV) dose in a two-period crossover design. Treatment periods were separated by a washout period of 3-14 days. The primary endpoint was change from baseline in pulmonary artery systolic pressure (PASP) measured by echocardiography. Secondary endpoints included RAS peptides and oxygen saturation.
RESULTS


Seventeen adults aged 18-40 years were randomised to treatment. There were no clinically relevant differences (defined as a reduction of ≥ 5 mmHg) in change from baseline in PASP between GSK2586881 and placebo. GSK2586881 was well tolerated, with no serious adverse events, no worsening of hypoxaemia and no evidence of immunogenicity. The study was terminated early after review of the data, which showed that the predefined success criteria had not been met. Following GSK2586881 administration, levels of the RAS peptide angiotensin II decreased while angiotensin (1-7) increased, as expected, indicating that GSK2586881 was pharmacologically active.
CONCLUSIONS


A single IV dose of GSK2586881 0.8 mg/kg was well tolerated but did not impact the acute HPV response in healthy volunteers.",2021,There were no clinically relevant differences (defined as a reduction of ≥ 5 mmHg) in change from baseline in PASP between GSK2586881 and placebo.,"['healthy volunteers', 'healthy adult volunteers during exercise under hypoxic conditions', 'Seventeen adults aged 18-40\xa0years']","['placebo', 'Placebo', 'Recombinant Human Angiotensin-Converting Enzyme 2', 'Angiotensin-converting enzyme 2 (ACE2']","['RAS peptides and oxygen saturation', 'tolerated', 'levels of the RAS peptide angiotensin', 'Response to Acute Hypoxia and Exercise', 'acute HPV response', 'worsening of hypoxaemia and no evidence of immunogenicity', 'pulmonary artery systolic pressure (PASP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1610422', 'cui_str': 'ACE2 protein, human'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}]",17.0,0.140328,There were no clinically relevant differences (defined as a reduction of ≥ 5 mmHg) in change from baseline in PASP between GSK2586881 and placebo.,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hall', 'Affiliation': 'Novel Human Genetics Research Unit, Medicines Research Centre, GlaxoSmithKline Plc., Gunnels Wood Road, Stevenage, SG1 2NY, Hertfordshire, UK. david.a.hall@gsk.com.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hanrott', 'Affiliation': 'Novel Human Genetics Research Unit, Medicines Research Centre, GlaxoSmithKline Plc., Gunnels Wood Road, Stevenage, SG1 2NY, Hertfordshire, UK.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Badorrek', 'Affiliation': 'Department of Clinical Airway Research, Fraunhofer Institute of Toxicology and Experimental Medicine, Hannover, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Berliner', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Budd', 'Affiliation': 'Novel Human Genetics Research Unit, Medicines Research Centre, GlaxoSmithKline Plc., Gunnels Wood Road, Stevenage, SG1 2NY, Hertfordshire, UK.'}, {'ForeName': 'Rhena', 'Initials': 'R', 'LastName': 'Eames', 'Affiliation': 'Novel Human Genetics Research Unit, Medicines Research Centre, GlaxoSmithKline Plc., Gunnels Wood Road, Stevenage, SG1 2NY, Hertfordshire, UK.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Powley', 'Affiliation': 'Novel Human Genetics Research Unit, Medicines Research Centre, GlaxoSmithKline Plc., Gunnels Wood Road, Stevenage, SG1 2NY, Hertfordshire, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hewens', 'Affiliation': 'Novel Human Genetics Research Unit, Medicines Research Centre, GlaxoSmithKline Plc., Gunnels Wood Road, Stevenage, SG1 2NY, Hertfordshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Siederer', 'Affiliation': 'Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Aili L', 'Initials': 'AL', 'LastName': 'Lazaar', 'Affiliation': 'Respiratory Therapy Area Unit, Research and Development, GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Novel Human Genetics Research Unit, Medicines Research Centre, GlaxoSmithKline Plc., Gunnels Wood Road, Stevenage, SG1 2NY, Hertfordshire, UK.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Hohlfeld', 'Affiliation': 'Department of Clinical Airway Research, Fraunhofer Institute of Toxicology and Experimental Medicine, Hannover, Germany.'}]",Pulmonary therapy,['10.1007/s41030-021-00164-7']
753,34192387,Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial.,"BACKGROUND


Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumor necrosis factor biologic.
OBJECTIVES


To report 3-year outcomes from the CIMPACT (NCT02346240) phase 3, CZP in moderate to severe plaque psoriasis, randomized controlled trial.
METHODS


Adults were randomized 3:3:3:1 to CZP 200 mg every other week (Q2W), CZP 400 mg Q2W, etanercept biweekly or placebo. At Week 16, CZP- and etanercept-treated PASI 75 responders were re-randomized to CZP 200 mg Q2W, CZP 400 mg Q4W, CZP 400 mg Q2W or placebo for maintenance treatment; PASI 75 non-responders entered an open-label escape CZP 400 mg Q2W arm. Patients entering the open-label extension (OLE; Weeks 48-144) from blinded treatment received CZP 200 mg Q2W.
RESULTS


Double-blinded results have been reported previously. 261 patients received 200 mg Q2W upon OLE entry. PASI 75 response was maintained in patients continuing 200 mg Q2W treatment through Weeks 16-144 (Week 144: 96.2%). In patients dosed down at Week 48 (double-blinded 400 mg to 200 mg Q2W), PASI 75 decreased (Week 48: 98.7%; Week 144: 85.9%). In patients who received placebo through Weeks 16-48, PASI 75 response decreased (Week 48: 60.4%), then increased following Week 48 switch to 200 mg Q2W (Week 144: 95.1%). 48 and 36 patients initially randomized to 200 and 400 mg Q2W, respectively, were Week 16 PASI 75 non-responders and entered the escape arm; at Week 144, 71.8% and 78.2% achieved PASI 75. No new safety signals were identified.
CONCLUSIONS


Response to CZP was durable over three years; no new safety signals were identified.",2021,PASI 75 response was maintained in patients continuing 200 mg Q2W treatment through Weeks 16-144,"['plaque psoriasis', '261 patients', 'Patients entering the open-label extension (OLE; Weeks 48-144', 'Adults']","['CZP- and etanercept', 'CIMPACT', 'certolizumab pegol', 'Certolizumab pegol (CZP', 'CZP 200 mg every other week (Q2W), CZP 400\xa0mg Q2W, etanercept biweekly, or placebo', 'placebo', 'CZP 200 mg Q2W, CZP 400 mg Q4W, CZP\xa0400\xa0mg Q2W, or placebo', 'CZP']",[],"[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.313782,PASI 75 response was maintained in patients continuing 200 mg Q2W treatment through Weeks 16-144,"[{'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sofen', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Piguet', 'Affiliation': 'Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': 'C Arendt', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fierens', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.17486']
754,34196498,"Safety and Efficacy of Upadacitinib in Patients With Active Ankylosing Spondylitis and an Inadequate Response to Nonsteroidal Antiinflammatory Drug Therapy: One-Year Results of a Double-Blind, Placebo-Controlled Study and Open-Label Extension.","OBJECTIVE


To report the efficacy and safety of upadacitinib through 1 year in patients with ankylosing spondylitis (AS).
METHODS


In the SELECT-AXIS 1 study, adults with active AS and an inadequate response to nonsteroidal antiinflammatory drugs were randomized to receive upadacitinib 15 mg once daily or placebo. At week 14, patients who had been randomized to receive placebo were switched to upadacitinib, and all patients continued in the open-label extension and received upadacitinib up to week 104; interim data up to week 64 are reported herein.
RESULTS


Of 187 patients, 178 completed week 14 on study drug and entered the open-label extension. Similar proportions of patients in either group (continuous upadacitinib or placebo-to-upadacitinib) achieved Assessment of SpondyloArthritis international Society 40% response (ASAS40) or Ankylosing Spondylitis Disease Activity Score (ASDAS) showing low disease activity at week 64: ≥70% of patients achieved these end points based on nonresponder imputation (NRI) and ≥81% based on as-observed analyses. Furthermore, ≥34% (NRI) and ≥39% (as-observed analysis) achieved ASDAS showing inactive disease or ASAS showing partial remission at week 64. Mean changes from baseline (week 0) to week 64 in pain, function, and inflammation showed consistent improvement or sustained maintenance through the study. Among 182 patients receiving upadacitinib (237.6 patient-years), 618 adverse events (260.1 per 100 patient-years) were reported. No serious infections, major adverse cardiovascular events, venous thromboembolic events, gastrointestinal perforation, or deaths were reported.
CONCLUSION


Upadacitinib 15 mg once daily showed sustained and consistent efficacy over 1 year. Patients who switched from placebo to upadacitinib at week 14 showed similar efficacy versus those who received continuous upadacitinib.",2021,"Mean changes from baseline (week 0) to week 64 in pain, function, and inflammation showed consistent improvement or sustained maintenance through the study.","['182 patients receiving upadacitinib (237.6 PY), 618 adverse events (260.1/100 PY) were reported', 'Active Ankylosing Spondylitis', 'adults with active AS and inadequate response to non-steroidal anti-inflammatory drugs', 'patients with ankylosing spondylitis (AS', 'Of 187 patients, 178 completed week 14 on study drug and entered the open-label extension']","['upadacitinib 15 mg once daily (QD) or placebo', 'Placebo', 'placebo']","['ASDAS inactive disease or ASAS partial remission', 'serious infections, major adverse cardiovascular events, venous thromboembolic events, gastrointestinal perforation, or deaths', 'Assessment of SpondyloArthritis international Society (ASAS) 40 or Ankylosing Spondylitis Disease Activity Score (ASDAS) low-disease activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C5196293', 'cui_str': 'upadacitinib 15 MG [Rinvoq]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0151664', 'cui_str': 'Gastrointestinal perforation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.100374,"Mean changes from baseline (week 0) to week 64 in pain, function, and inflammation showed consistent improvement or sustained maintenance through the study.","[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Sieper', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Van den Bosch', 'Affiliation': 'VIB-UGent Center for Inflammation Research and Ghent University, Ghent, Belgium.'}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Maksymowych', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Tae-Hwan', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.'}, {'ForeName': 'Mitsumasa', 'Initials': 'M', 'LastName': 'Kishimoto', 'Affiliation': 'Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ostor', 'Affiliation': 'Cabrini Medical Center and Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'Centre Hospitalier Universitaire de Montpellier and Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Yunxia', 'Initials': 'Y', 'LastName': 'Sui', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Alvina D', 'Initials': 'AD', 'LastName': 'Chu', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41911']
755,34197135,Evaluating cannabis use risk reduction as an alternative clinical outcome for cannabis use disorder.,"OBJECTIVE


Abstinence is rarely achieved in clinical trials for cannabis use disorder (CUD). Cannabis reduction is associated with functional improvement, but reduction endpoints have not been established, indicating a need to identify and validate clinically meaningful reduction endpoints for assessing treatment efficacy.
METHOD


Data from a 12-week double-blind randomized placebo-controlled medication trial for cannabis cessation (NCT01675661) were analyzed. Participants ( N  = 225) were treatment-seeking adults,  M  = 30.6 (8.9) years old, 70.2% male, and 42.2% Non-White, with CUD who completed 12 weeks of treatment. Frequency (days of use per week) and quantity (grams per using day) were used to define high-, medium-, and low-risk levels. Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale and cannabis-related problems were assessed using the Marijuana Problems Scale. General linear models for repeated measures tested associations between the magnitude of risk reduction and functional outcomes from baseline (BL) to end-of-treatment (EOT).
RESULTS


Cannabis risk levels were sensitive to reductions in use from BL to EOT for frequency- ( χ ² = 19.35,  p  = .004) and quantity-based ( χ ² = 52.06,  p  < .001) metrics. Magnitude reduction in frequency-based risk level was associated with magnitude decrease in depression ( F  = 2.76,  p  = .043, η p ² = .04), anxiety ( F  = 3.70,  p  = .013, η p ² = .05), and cannabis-related problems ( F  = 8.95,  p  < .001, η p ² = .12). Magnitude reduction in quantity-based risk level was associated with magnitude decrease in anxiety ( F  = 3.02,  p  = .031, η p ² = .04) and cannabis-related problems ( F  = 3.24,  p  = .023, η p ² = .05).
CONCLUSIONS


Cannabis use risk levels, as operationalized in this study, captured reductions in use during a clinical trial. Risk level reduction was associated with functional improvement suggesting that identifying risk levels and measuring the change in levels over time may be a viable and clinically meaningful endpoint for determining treatment efficacy. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Magnitude reduction in quantity-based risk level was associated with magnitude decrease in anxiety ( F  = 3.02,  p  = .031, η p ² = .04) and cannabis-related problems ( F  = 3.24,  p  = .023, η p ² = .05).
","['Participants ( N  = 225) were treatment-seeking adults,  M  = 30.6 (8.9) years old, 70.2% male, and 42.2% Non-White, with CUD who completed 12 weeks of treatment']",['placebo'],"['Anxiety and depression', 'anxiety', 'depression', 'quantity-based risk level', 'frequency-based risk level', 'Hospital Anxiety and Depression Scale and cannabis-related problems']","[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",225.0,0.0487493,"Magnitude reduction in quantity-based risk level was associated with magnitude decrease in anxiety ( F  = 3.02,  p  = .031, η p ² = .04) and cannabis-related problems ( F  = 3.24,  p  = .023, η p ² = .05).
","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Sherman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sofis', 'Affiliation': 'Department of Research & Evaluation.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Borodovsky', 'Affiliation': 'Department of Biomedical Data Science.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'McRae-Clark', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Budney', 'Affiliation': 'Center for Technology and Behavioral Health.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000760']
756,34212195,Interleukin-2 Transiently Inhibits Pulsatile Growth Hormone Secretion in Young but not Older Healthy Men.,"CONTEXT


Interleukin-2 (IL-2), a proinflammatory cytokine, has been used to treat malignancies. Increased cortisol and adrenocorticotropin (ACTH) were noted, but growth hormone (GH) secretion was not investigated in detail.
OBJECTIVE


We quantified GH secretion after a single subcutaneous injection of IL-2 in 17 young and 18 older healthy men in relation to dose, age, and body composition.
METHODS


This was a placebo-controlled, blinded, prospectively randomized, crossover study. At 20:00 hours IL-2 (3 or 6 million units/m2) or saline was injected subcutaneously. Lights were off between 23:00 and 07:00 hours. Blood was sampled at 10-minute intervals for 24 hours. Outcome measures included convolution analysis of GH secretion.
RESULTS


GH profiles were pulsatile under both experimental conditions and lower in older than young volunteers. Since the effect of IL-2 might be time limited, GH analyses were performed on the complete 24-hour series and the 6 hours after IL-2 administration. Total and pulsatile 24-hour GH secretion decreased nonsignificantly. Pulsatile secretion fell over the first 6 hours after IL-2 (P = .03), with visceral fat as a covariate (P = .003), but not age (P = .10). Plots of cumulative 2-hour bins of GH pulse mass showed a distinction by treatment and age groups: A temporary GH decrease of 32% and 28% occurred in the first 2-hour bins after midnight (P = .02 and .04) in young participants, whereas in older individuals no differences were present at any time point.
CONCLUSION


This study demonstrates that IL-2 temporarily diminishes GH secretion in young, but not older, men.",2021,"Pulsatile secretion fell over the first 6 h after IL2 (P=0.034), with visceral fat as covariate (P=0.003), but not age(P=0.10).","['Young but not Older Healthy Men', '17 young and 18 older healthy men in relation to dose, age and body composition']","['Interleukin-2', 'placebo', 'saline']","['GH secretion', 'Pulsatile secretion fell', 'Total and pulsatile 24-h GH secretion', 'Increased cortisol and ACTH', 'Pulsatile Growth Hormone Secretion', 'temporary GH decrease']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0239787', 'cui_str': 'Growth hormone decreased'}]",,0.058995,"Pulsatile secretion fell over the first 6 h after IL2 (P=0.034), with visceral fat as covariate (P=0.003), but not age(P=0.10).","[{'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Roelfsema', 'Affiliation': 'Department of Internal Medicine, Section Endocrinology, Leiden University Medical, Center, 2333ZA Leiden, the Netherlands.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Endocrine Research Unit, Mayo Clinic College of Medicine, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota 55905,USA.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Endocrine Research Unit, Mayo Clinic College of Medicine, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota 55905,USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab484']
757,34214454,Half-Dose Photodynamic Therapy Versus Eplerenone in Chronic Central Serous Chorioretinopathy (SPECTRA): A Randomized Controlled Trial.,"PURPOSE


To compare the efficacy and safety between half-dose photodynamic therapy (PDT) and eplerenone therapy for treating chronic central serous chorioretinopathy (cCSC).
DESIGN


This was a multicenter, open-label, randomized controlled trial.
METHODS


This investigator-initiated trial was conducted in 3 academic medical centers in the Netherlands. Eligible patients were randomized at a 1:1 ratio to receive either indocyanine green angiography-guided half-dose PDT or oral eplerenone for 12 weeks. Both anatomical and functional outcomes were evaluated at 3 months after the start of treatment.
RESULTS


A total of 107 patients were randomly assigned to receive either half-dose PDT (n = 53) or eplerenone treatment (n = 54). Thirteen patients (3 in the PDT group and 10 in the eplerenone group) did not adhere to the study protocol. At the 3-month evaluation visit, 78% of patients in the PDT group had complete resolution of subretinal fluid accumulation compared to only 17% of patients in the eplerenone group (P < .001). Mean best-corrected visual acuity in Early Treatment of Diabetic Retinopathy Study letters at the 3-month evaluation visit was 83.7 ± 10.8 and 82.8 ± 9.0 in the PDT and eplerenone groups, respectively (P = .555). In addition, mean retinal sensitivity on microperimetry was 25.4 ± 3.4 dB and 23.9 ± 4.0 dB in the PDT and eplerenone groups, respectively (P = .041). Finally, mean vision-related quality of life scores were 87.2 ± 8.5 and 83.8 ± 12.1 in the PDT and eplerenone groups, respectively (P = .094). Three patients (6%) in the PDT group experienced adverse events during the study compared to 18 patients (33%) in the eplerenone group.
CONCLUSIONS


Half-dose PDT is superior to oral eplerenone for cCSC with respect to both short-term safety and efficacy outcomes.",2021,"Mean best-corrected visual acuity in Early Treatment of Diabetic Retinopathy Study letters at the evaluation visit was 83.7±10.8 and 82.8±9.0 in the PDT and eplerenone groups, respectively (p=0.555).","['3 academic medical centers in the Netherlands', 'Thirteen patients (3 in the PDT group and 10 in the eplerenone group) did not adhere to the study protocol', 'A total of 107 patients', 'Eligible patients', 'chronic central serous chorioretinopathy (SPECTRA', 'chronic central serous chorioretinopathy (cCSC']","['indocyanine green angiography-guided half-dose PDT or oral eplerenone', 'eplerenone treatment', 'eplerenone', 'photodynamic therapy (PDT) and eplerenone', 'photodynamic therapy versus eplerenone', 'PDT']","['efficacy and safety', 'Mean best-corrected visual acuity', 'mean vision-related quality of life scores', 'mean retinal sensitivity on microperimetry', 'complete resolution of SRF', 'adverse events']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0730314', 'cui_str': 'Chronic central serous chorioretinopathy'}]","[{'cui': 'C0430879', 'cui_str': 'Indocyanine green angiography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",107.0,0.120766,"Mean best-corrected visual acuity in Early Treatment of Diabetic Retinopathy Study letters at the evaluation visit was 83.7±10.8 and 82.8±9.0 in the PDT and eplerenone groups, respectively (p=0.555).","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'van Rijssen', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, the Netherlands (T.J.v.R., E.H.C.v.D, H.M.A.F., G.D., C.J.F.B.).'}, {'ForeName': 'Elon H C', 'Initials': 'EHC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, the Netherlands (T.J.v.R., E.H.C.v.D, H.M.A.F., G.D., C.J.F.B.).'}, {'ForeName': 'Roula', 'Initials': 'R', 'LastName': 'Tsonaka', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands (R.T.).'}, {'ForeName': 'Helena M A', 'Initials': 'HMA', 'LastName': 'Feenstra', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, the Netherlands (T.J.v.R., E.H.C.v.D, H.M.A.F., G.D., C.J.F.B.).'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Dijkman', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, the Netherlands (T.J.v.R., E.H.C.v.D, H.M.A.F., G.D., C.J.F.B.).'}, {'ForeName': 'Petrus J H', 'Initials': 'PJH', 'LastName': 'Peters', 'Affiliation': 'Department of Ophthalmology, Bergman Clinics B.V., Velp, the Netherlands (P.J.H.P.).'}, {'ForeName': 'Roselie M H', 'Initials': 'RMH', 'LastName': 'Diederen', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands (R.M.H.D., R.O.S., C.J.F.B.).'}, {'ForeName': 'Carel B', 'Initials': 'CB', 'LastName': 'Hoyng', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, the Netherlands (C.B.H.).'}, {'ForeName': 'Reinier O', 'Initials': 'RO', 'LastName': 'Schlingemann', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands (R.M.H.D., R.O.S., C.J.F.B.).'}, {'ForeName': 'Camiel J F', 'Initials': 'CJF', 'LastName': 'Boon', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, the Netherlands (T.J.v.R., E.H.C.v.D, H.M.A.F., G.D., C.J.F.B.); Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands (R.M.H.D., R.O.S., C.J.F.B.). Electronic address: camiel.boon@amsterdamumc.nl.'}]",American journal of ophthalmology,['10.1016/j.ajo.2021.06.020']
758,34218329,Reducing adenoma miss rate of colonoscopy assisted by artificial intelligence: a multicenter randomized controlled trial.,"BACKGROUND


We have developed the computer-aided detection (CADe) system using an original deep learning algorithm based on a convolutional neural network for assisting endoscopists in detecting colorectal lesions during colonoscopy. The aim of this study was to clarify whether adenoma miss rate (AMR) could be reduced with CADe assistance during screening and surveillance colonoscopy.
METHODS


This study was a multicenter randomized controlled trial. Patients aged 40 to 80 years who were referred for colorectal screening or surveillance at four sites in Japan were randomly assigned at a 1:1 ratio to either the ""standard colonoscopy (SC)-first group"" or the ""CADe-first group"" to undergo a back-to-back tandem procedure. Tandem colonoscopies were performed on the same day for each participant by the same endoscopist in a preassigned order. All polyps detected in each pass were histopathologically diagnosed after biopsy or resection.
RESULTS


A total of 358 patients were enrolled and 179 patients were assigned to the SC-first group or CADe-first group. The AMR of the CADe-first group was significantly lower than that of the SC-first group (13.8% vs. 36.7%, P < 0.0001). Similar results were observed for the polyp miss rate (14.2% vs. 40.6%, P < 0.0001) and sessile serrated lesion miss rate (13.0% vs. 38.5%, P = 0.03). The adenoma detection rate of CADe-assisted colonoscopy was 64.5%, which was significantly higher than that of standard colonoscopy (53.6%; P = 0.036).
CONCLUSION


Our study results first showed a reduction in the AMR when assisting with CADe based on deep learning in a multicenter randomized controlled trial.",2021,"Similar results were observed for the polyp miss rate (14.2% vs. 40.6%, P < 0.0001) and sessile serrated lesion miss rate (13.0% vs. 38.5%, P = 0.03).","['358 patients were enrolled and 179 patients', 'Patients aged 40 to 80\xa0years who were referred for colorectal screening or surveillance at four sites in Japan']","['colonoscopy assisted by artificial intelligence', 'SC-first group or CADe-first group', 'CADe', 'standard colonoscopy (SC)-first group"" or the ""CADe-first group"" to undergo a back-to-back tandem procedure']","['adenoma detection rate of CADe-assisted colonoscopy', 'polyp miss rate', 'adenoma miss rate (AMR', 'sessile serrated lesion miss rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0205348', 'cui_str': 'Sessile'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",358.0,0.142102,"Similar results were observed for the polyp miss rate (14.2% vs. 40.6%, P < 0.0001) and sessile serrated lesion miss rate (13.0% vs. 38.5%, P = 0.03).","[{'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Kamba', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan. kanba@jikei.ac.jp.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Tamai', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Iduru', 'Initials': 'I', 'LastName': 'Saitoh', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Matsui', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Hideka', 'Initials': 'H', 'LastName': 'Horiuchi', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Masakuni', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine Third Hospital, 4-11-1 Izumihoncho, Komae-shi, Tokyo, 201-8601, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Endoscopy Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Ego', 'Affiliation': 'Endoscopy Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Fukuda', 'Affiliation': 'LPIXEL Inc., 1-6-1 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Tonouchi', 'Affiliation': 'LPIXEL Inc., 1-6-1 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Shimahara', 'Affiliation': 'LPIXEL Inc., 1-6-1 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Nishikawa', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Haruo', 'Initials': 'H', 'LastName': 'Nishino', 'Affiliation': 'Coloproctology Center, Matsushima Hospital, 3-138 Isecho, Nishi-ku, Yokohama-shi, Kanagawa, 220-0045, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Endoscopy Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Sumiyama', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-021-01808-w']
759,34218304,Comparative study evaluating antihistamine versus leukotriene receptor antagonist as adjuvant therapy for rheumatoid arthritis.,"PURPOSE


Investigating the efficacy and safety of rupatadine (RUP) versus montelukast (MON) as adjuvant therapy for patients with rheumatoid arthritis (RA).
METHODS


From December 2018 to December 2019, 75 patients with active RA were enrolled in this randomized double-blind placebo-controlled study. The patients were randomized into three groups (n = 25 in each group); methotrexate (MTX) group which received MTX 15-25 mg/week plus placebo tablet once daily; MTX/RUP group which received MTX plus RUP 10 mg once daily; and MTX/MON group which received MTX plus MON 10 mg once daily. The treatment duration was 3 months. At baseline and 3 months after treatment, blood samples were collected for the biochemical analysis of high-sensitivity C-reactive protein (hs-CRP), interleukins 8 and 17 (IL-8, IL-17), E-selectin, and clusterin (CLU) levels. Clinical and functional assessments using Disease Activity Score-CRP (DAS28-CRP) and Multidimensional Health Assessment Questionnaire (MDHAQ) were performed.
RESULTS


Both RUP and MON produced clinical and functional improvements which were translated by significant improvements in DAS28-CRP score and MDHAQ. Rupatadine significantly reduced all measured parameters (P < 0.05) except for IL-17 and CLU. Montelukast significantly decreased all measured variables (P < 0.05) except for E-selectin. Interleukin-8 was positively correlated with IL-17 and CLU, while hs-CRP was positively correlated with E-selectin and body mass index (BMI). Both drugs were well tolerated; somnolence was the common side effect for RUP. No neuropsychiatric events were reported with MON.
CONCLUSION


Rupatadine or montelukast may serve as a potential adjuvant therapy for patients with rheumatoid arthritis secondary to the preliminary evidence of efficacy and safety. ClinicalTrials.gov identifier NCT03770923, December 10, 2018.",2021,Both RUP and MON produced clinical and functional improvements which were translated by significant improvements in DAS28-CRP score and MDHAQ.,"['patients with rheumatoid arthritis', 'patients with rheumatoid arthritis (RA', 'rheumatoid arthritis', 'From December 2018 to December 2019', '75 patients with active RA']","['Montelukast', 'rupatadine (RUP) versus montelukast (MON', 'methotrexate (MTX', 'Rupatadine or montelukast', 'MTX 15-25\xa0mg/week plus placebo tablet once daily; MTX/RUP group which received MTX plus RUP 10\xa0mg once daily; and MTX/MON group which received MTX plus', 'antihistamine versus leukotriene receptor antagonist', 'placebo']","['DAS28-CRP score and MDHAQ', 'Disease Activity Score-CRP (DAS28-CRP) and Multidimensional Health Assessment Questionnaire (MDHAQ', 'tolerated; somnolence', 'high-sensitivity C-reactive protein (hs-CRP), interleukins 8 and 17 (IL-8, IL-17), E-selectin, and clusterin (CLU) levels', 'E-selectin and body mass index (BMI', 'neuropsychiatric events', 'Interleukin-8', 'IL-17 and CLU, while hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0534301', 'cui_str': 'rupatadine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0595726', 'cui_str': 'Leukotriene receptor antagonist'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0055966', 'cui_str': 'Apolipoprotein J'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",75.0,0.40466,Both RUP and MON produced clinical and functional improvements which were translated by significant improvements in DAS28-CRP score and MDHAQ.,"[{'ForeName': 'Tarek Mohamed', 'Initials': 'TM', 'LastName': 'Mostafa', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, 31527, Egypt.'}, {'ForeName': 'Sahar Kamal', 'Initials': 'SK', 'LastName': 'Hegazy', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, 31527, Egypt.'}, {'ForeName': 'Salwa El-Morsy Abd', 'Initials': 'SEA', 'LastName': 'El-Ghany', 'Affiliation': 'Rheumatology & Rehabilitation Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Fedaa Abd El-Monem', 'Initials': 'FAE', 'LastName': 'Kotkata', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, 31527, Egypt. Fedaa.kamaleldeen@pharm.tanta.edu.eg.'}]",European journal of clinical pharmacology,['10.1007/s00228-021-03181-2']
760,34174225,Exoskeleton-Assisted Anthropomorphic Movement Training (EAMT) for Poststroke Upper Limb Rehabilitation: A Pilot Randomized Controlled Trial.,"OBJECTIVE


To investigate the feasibility of exoskeleton-assisted anthropomorphic movement training (EAMT) and its effects on upper extremity motor impairment, function, and kinematics after stroke.
DESIGN


A single-blind pilot randomized controlled trial.
SETTING


Stroke rehabilitation inpatient unit.
PARTICIPANTS


Participants with a hemiplegia (N=20) due to a first-ever, unilateral, subacute stroke who had a score of 8-47 on the Fugl-Meyer Assessment for Upper Extremity (FMA-UE).
INTERVENTIONS


The exoskeleton group received EAMT therapy that provided task-specific training under anthropomorphic trajectories and postures. The control group received conventional upper limb therapy. For both groups, therapy was delivered at the same intensity, frequency, and duration: 45 minutes daily, 5 days per week, for 4 weeks.
MAIN OUTCOME MEASURES


Primary outcome: feasibility analysis.
SECONDARY OUTCOMES


FMA-UE, Action Research Arm Test (ARAT), modified Barthel Index (MBI), and kinematic metrics during exoskeleton therapy.
RESULTS


Twenty participants with subacute stroke were recruited and completed all therapy sessions. EAMT therapy was feasible and acceptable for the participants. The recruitment rate, retention rate, and number of therapists required for EAMT therapy were acceptable compared with other robotic trials. EAMT was determined to be safe, as no adverse event occurred except tolerable muscle fatigue in 2 participants. There were significant between-group differences in the change scores of FMA-UE (difference, 4.30 points; P=.04) and MBI (difference, 8.70 points; P=.03) in favor of EAMT therapy. No significant between-group difference was demonstrated for the change scores of ARAT (P=.18). Participants receiving EAMT showed significant improvements in kinematic metrics after treatment (P<.01).
CONCLUSIONS


Our results indicate that EAMT is a feasible approach and may improve upper extremity motor impairment, activities of daily living, and kinematics after stroke. However, fully powered randomized controlled trials are warranted to confirm the results of this pilot study and explore the underlying mechanisms by which EAMT therapy might work.",2021,"There were significant between-group differences in the change scores of FMA-UE (difference, 4.30 points; P=0.04) and MBI (difference, 8.70 points; P=0.03) in favor of EAMT therapy.","['Participants with a hemiplegia due to a first-ever, unilateral, subacute stroke who had a score of 8 to 47 on the Fugl-Meyer Assessment for Upper Extremity', 'Twenty participants with subacute stroke', 'Post-stroke Upper Limb Rehabilitation', 'Stroke rehabilitation inpatient unit']","['conventional upper limb therapy', 'EAMT', 'exoskeleton-assisted anthropomorphic movement training (EAMT', 'Exoskeleton-assisted Anthropomorphic Movement Training (EAMT', 'EAMT therapy', 'EAMT therapy that provided task-specific training']","['change scores of ARAT', 'change scores of FMA-UE', 'MBI', 'Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Action Research Arm Test (ARAT), modified Barthel Index (MBI), and kinematic metrics during exoskeleton therapy', 'kinematic metrics', 'recruitment rate, retention rate and number of therapists required for EAMT therapy']","[{'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",20.0,0.0968839,"There were significant between-group differences in the change scores of FMA-UE (difference, 4.30 points; P=0.04) and MBI (difference, 8.70 points; P=0.03) in favor of EAMT therapy.","[{'ForeName': 'Ze-Jian', 'Initials': 'ZJ', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan; World Health Organization Cooperative Training and Research Center in Rehabilitation, Wuhan.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Institute of Rehabilitation and Medical Robotics, State Key Lab of Digital Manufacturing Equipment and Technology, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan; World Health Organization Cooperative Training and Research Center in Rehabilitation, Wuhan.'}, {'ForeName': 'Cai-Hua', 'Initials': 'CH', 'LastName': 'Xiong', 'Affiliation': 'Institute of Rehabilitation and Medical Robotics, State Key Lab of Digital Manufacturing Equipment and Technology, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiao-Lin', 'Initials': 'XL', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan; World Health Organization Cooperative Training and Research Center in Rehabilitation, Wuhan. Electronic address: xiaolinh2006@126.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.06.001']
761,34175150,Re: Radical Cystectomy Against Intravesical BCG for High-risk High-grade Nonmuscle Invasive Bladder Cancer: Results from the Randomized Controlled BRAVO-feasibility Study.,,2021,,['High-risk High-grade Nonmuscle Invasive Bladder Cancer'],['Re: Radical Cystectomy Against Intravesical BCG'],[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C1289970', 'cui_str': 'Intravesical BCG'}]",[],,0.136847,,"[{'ForeName': 'Girish S', 'Initials': 'GS', 'LastName': 'Kulkarni', 'Affiliation': 'Divisions of Urology and Surgical Oncology, Department of Surgery, University of Toronto, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, Toronto, Canada. Electronic address: girish.kulkarni@uhn.ca.'}]",European urology,['10.1016/j.eururo.2021.05.034']
762,34175148,"Re: Prostate-specific Membrane Antigen PET-CT in Patients with High-risk Prostate Cancer Before Curative-intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomised, Multicentre Study.",,2021,,['Patients with High-risk Prostate Cancer'],"['Re: Prostate-specific Membrane Antigen PET-CT', 'Curative-intent Surgery or Radiotherapy (proPSMA']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.0513506,,"[{'ForeName': 'Vidit', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Department of Urology, Mayo Clinic, Rochester, MN, USA; VA Health Services Research and Development, Department of Urology, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'R Jeffrey', 'Initials': 'RJ', 'LastName': 'Karnes', 'Affiliation': 'Department of Urology, Mayo Clinic, Rochester, MN, USA. Electronic address: karnes.r@mayo.edu.'}]",European urology,['10.1016/j.eururo.2021.05.037']
763,34189814,Admission computed tomography radiomic signatures outperform hematoma volume in predicting baseline clinical severity and functional outcome in the ATACH-2 trial intracerebral hemorrhage population.,"BACKGROUND AND PURPOSE


Radiomics provides a framework for automated extraction of high-dimensional feature sets from medical images. We aimed to determine radiomics signature correlates of admission clinical severity and medium-term outcome from intracerebral hemorrhage (ICH) lesions on baseline head computed tomography (CT).
METHODS


We used the ATACH-2 (Antihypertensive Treatment of Acute Cerebral Hemorrhage II) trial dataset. Patients included in this analysis (n = 895) were randomly allocated to discovery (n = 448) and independent validation (n = 447) cohorts. We extracted 1130 radiomics features from hematoma lesions on baseline noncontrast head CT scans and generated radiomics signatures associated with admission Glasgow Coma Scale (GCS), admission National Institutes of Health Stroke Scale (NIHSS), and 3-month modified Rankin Scale (mRS) scores. Spearman's correlation between radiomics signatures and corresponding target variables was compared with hematoma volume.
RESULTS


In the discovery cohort, radiomics signatures, compared to ICH volume, had a significantly stronger association with admission GCS (0.47 vs. 0.44, p = 0.008), admission NIHSS (0.69 vs. 0.57, p < 0.001), and 3-month mRS scores (0.44 vs. 0.32, p < 0.001). Similarly, in independent validation, radiomics signatures, compared to ICH volume, had a significantly stronger association with admission GCS (0.43 vs. 0.41, p = 0.02), NIHSS (0.64 vs. 0.56, p < 0.001), and 3-month mRS scores (0.43 vs. 0.33, p < 0.001). In multiple regression analysis adjusted for known predictors of ICH outcome, the radiomics signature was an independent predictor of 3-month mRS in both cohorts.
CONCLUSIONS


Limited by the enrollment criteria of the ATACH-2 trial, we showed that radiomics features quantifying hematoma texture, density, and shape on baseline CT can provide imaging correlates for clinical presentation and 3-month outcome. These findings couldtrigger a paradigm shift where imaging biomarkers may improve current modelsfor prognostication, risk-stratification, and treatment triage of ICH patients.",2021,"In multiple regression analysis adjusted for known predictors of ICH outcome, the radiomics signature was an independent predictor of 3-month mRS in both cohorts.
",['Patients included in this analysis (n=895) were randomly allocated to discovery (n=448) and independent validation (n=447) cohorts'],[],"['admission NIHSS', 'admission GCS', 'NIHSS', '3-month mRS scores', 'admission Glasgow Coma Scale (GCS), admission National Institutes of Health Stroke Scale (NIHSS), and 3-month modified Rankin Scale (mRS) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",895.0,0.113039,"In multiple regression analysis adjusted for known predictors of ICH outcome, the radiomics signature was an independent predictor of 3-month mRS in both cohorts.
","[{'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Haider', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Abhi', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Hishan', 'Initials': 'H', 'LastName': 'Tharmaseelan', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Elisa R', 'Initials': 'ER', 'LastName': 'Berson', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Zeevi', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Majidi', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Filippi', 'Affiliation': 'Department of Radiology, Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Iseke', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Gross', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Julian N', 'Initials': 'JN', 'LastName': 'Acosta', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Sansing', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Guido J', 'Initials': 'GJ', 'LastName': 'Falcone', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Seyedmehdi', 'Initials': 'S', 'LastName': 'Payabvash', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, CT, USA.'}]",European journal of neurology,['10.1111/ene.15000']
764,34192418,Effect of acupuncture combined with rehabilitation on cognitive and motor functions in poststroke patients.,"The aim of the study was to explore the effect of acupuncture combined with rehabilitation on cognitive and motor functions in poststroke patients. All patients were divided into Group A and Group B based on different interventions (Group A: acupuncture + conventional rehabilitation, Group B: conventional rehabilitation alone). Acupuncture was conducted once a day, five times a week for 8 weeks, and rehabilitation (including physical therapy and occupational therapy) was conducted for 2 hr per session, once a day, five times a week for 8 weeks. Mini-mental State Examination (MMSE) and Fugl-Meyer Assessment (FMA) were used to assess the motor and cognitive functions at baseline and the end of 8 weeks. After the intervention, FMA and MMSE scores were improved significantly in the two groups (p <.05), compared with the scores prior to intervention. After 8 weeks of intervention, a statistically significant difference in the FMA and MMSE scores was observed between the Group A and the Group B. The results suggested that the combined intervention is more effective than the conventional rehabilitation alone in improving cognitive and motor functions in poststroke patients.",2021,"After 8 weeks of intervention, a statistically significant difference in the FMA and MMSE scores was observed between the Group A and the Group B.",['poststroke patients'],"['Mini-mental State Examination (MMSE) and Fugl-Meyer Assessment (FMA', 'Acupuncture', 'acupuncture\u2009+\u2009conventional rehabilitation, Group B: conventional rehabilitation alone', 'acupuncture combined with rehabilitation']","['cognitive and motor functions', 'FMA and MMSE scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}]",,0.0109717,"After 8 weeks of intervention, a statistically significant difference in the FMA and MMSE scores was observed between the Group A and the Group B.","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': ""Department of Rehabilitation Medicine, Yuebei People's Hospital, Shaoguan, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Yuebei People's Hospital, Shaoguan, China.""}, {'ForeName': 'Howe', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Therapy, University of North Texas Health Science Center, Fort Worth, Texas, USA.'}, {'ForeName': 'Hong-Fei', 'Initials': 'HF', 'LastName': 'Shi', 'Affiliation': 'Department of Rehabilitation Medicine, The Fourth Affiliated Hospital, Zhejiang University School of Medicine, Yiwu, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Rehabilitation Medicine, Shaoguan Railway Hospital, Shaoguan, China.'}, {'ForeName': 'Ming-Hong', 'Initials': 'MH', 'LastName': 'Wang', 'Affiliation': ""Department of Rehabilitation Medicine, Yuebei People's Hospital, Shaoguan, China.""}, {'ForeName': 'Ju-Ying', 'Initials': 'JY', 'LastName': 'Xie', 'Affiliation': 'Department of Rehabilitation Medicine, Affiliated Hospital of Xiangnan University, Chenzhou, China.'}]","Anatomical record (Hoboken, N.J. : 2007)",['10.1002/ar.24700']
765,34196397,Assessment of the Validity of the Sinonasal Outcomes Test-22 in Pituitary Surgery: A Multicenter Prospective Trial.,"OBJECTIVES/HYPOTHESIS


Sinonasal Outcomes Test-22 (SNOT-22) is used widely as a patient-reported sinonasal quality-of-life (QOL) instrument for endoscopic endonasal pituitary surgery. However, it has never been validated in this population. This study explores the psychometric validity of SNOT-22 to determine if it is a valid scale in patients undergoing endoscopic pituitary surgery.
STUDY DESIGN


Multicenter prospective trial.
METHODS


Adult patients (n = 113) with pituitary tumors undergoing endoscopic surgery were enrolled in a multicenter study. Patient-reported QOL was assessed using SNOT-22 and the Anterior Skull Base Nasal Inventory-12. Face validity, internal consistency, responsiveness to clinical change, test-retest reliability, and concurrent validity were determined using standard statistical methods.
RESULTS


Internal consistency using Cronbach's alpha at baseline and 2 weeks postoperatively were 0.911 and 0.922, indicating SNOT-22 performed well as a single construct. Mean QOL scores were significantly worse at 2 weeks than baseline (16.4 ± 15.1 vs. 23.1 ± 16.4, P < .001), indicating the scale is responsive to clinical change. However, only 11/22 items demonstrated significant changes in mean scores at 2 weeks. Correlation between scores at 2 and 3 weeks was high, suggesting good test-retest reliability, r(107) = 0.75, P < .001. Factor analysis suggests the five-factor solution proposed for the SNOT-22 in rhinosinusitis patients is not valid in pituitary surgery patients.
CONCLUSIONS


The SNOT-22 is a valid QOL instrument in patients undergoing endoscopic pituitary surgery. However, because it includes 22 items, can be applied only as a single construct, 50% of the items do not demonstrate changes after surgery, and is not as sensitive to change as other scales, shorter instruments developed specifically for this patient population may be preferable.
LEVEL OF EVIDENCE


2 Laryngoscope, 131:E2757-E2763, 2021.",2021,"Mean QOL scores were significantly worse at 2 weeks than baseline (16.4 ± 15.1 vs. 23.1 ± 16.4, P < .001), indicating the scale is responsive to clinical change.","['113) with pituitary tumors undergoing endoscopic surgery', 'Adult patients (n\xa0', 'patients undergoing endoscopic pituitary surgery', 'Pituitary Surgery', 'pituitary surgery patients']",[],"['mean scores', 'QOL', 'Face validity, internal consistency, responsiveness to clinical change, test-retest reliability, and concurrent validity', 'Mean QOL scores']","[{'cui': 'C0032019', 'cui_str': 'Neoplasm of pituitary gland'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042284', 'cui_str': 'Face Validity'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",,0.0709544,"Mean QOL scores were significantly worse at 2 weeks than baseline (16.4 ± 15.1 vs. 23.1 ± 16.4, P < .001), indicating the scale is responsive to clinical change.","[{'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Sarris', 'Affiliation': ""Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, U.S.A.""}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Little', 'Affiliation': ""Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, U.S.A.""}, {'ForeName': 'Varun R', 'Initials': 'VR', 'LastName': 'Kshettry', 'Affiliation': 'Department of Neurosurgery and Brain Tumor and Neuro-Oncology Center, Cleveland Clinic Foundation, Cleveland, Ohio, U.S.A.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Rosen', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, U.S.A.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Rehl', 'Affiliation': 'Arizona Sinus Center, Valley ENT, Phoenix, Arizona, U.S.A.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Haegen', 'Affiliation': 'Arizona Sinus Center, Valley ENT, Phoenix, Arizona, U.S.A.'}, {'ForeName': 'Mindy R', 'Initials': 'MR', 'LastName': 'Rabinowitz', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, U.S.A.'}, {'ForeName': 'Gurston G', 'Initials': 'GG', 'LastName': 'Nyquist', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, U.S.A.'}, {'ForeName': 'Pablo F', 'Initials': 'PF', 'LastName': 'Recinos', 'Affiliation': 'Department of Neurosurgery and Brain Tumor and Neuro-Oncology Center, Cleveland Clinic Foundation, Cleveland, Ohio, U.S.A.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sindwani', 'Affiliation': 'Department of Neurosurgery and Brain Tumor and Neuro-Oncology Center, Cleveland Clinic Foundation, Cleveland, Ohio, U.S.A.'}, {'ForeName': 'Troy D', 'Initials': 'TD', 'LastName': 'Woodard', 'Affiliation': 'Department of Neurosurgery and Brain Tumor and Neuro-Oncology Center, Cleveland Clinic Foundation, Cleveland, Ohio, U.S.A.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Farrell', 'Affiliation': 'Department of Neurological Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, U.S.A.'}, {'ForeName': 'Griffin D', 'Initials': 'GD', 'LastName': 'Santarelli', 'Affiliation': 'Arizona Otolaryngology Consultants, Phoenix, Arizona, U.S.A.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Milligan', 'Affiliation': 'Arizona Otolaryngology Consultants, Phoenix, Arizona, U.S.A.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Evans', 'Affiliation': 'Department of Neurological Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, U.S.A.'}]",The Laryngoscope,['10.1002/lary.29711']
766,34197586,"Letter to the Editor from Xu and Yang: ""Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules: 12-Month Results of a Randomized Trial (LARA II Study)"".",,2021,,[],['Letter to the Editor from [Xiequn Xu]: (Laser Ablation versus Radiofrequency Ablation'],[],[],"[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]",[],,0.0473798,,"[{'ForeName': 'Shijie', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiequn', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab491']
767,34213086,Yoga for cancer survivors with chemotherapy-induced peripheral neuropathy: Health-related quality of life outcomes.,"BACKGROUND


Yoga is a meditative movement therapy focused on mind-body awareness. The impact of yoga on health-related quality of life (HRQOL) outcomes in patients with chemotherapy-induced peripheral neuropathy (CIPN) is unclear.
METHODS


We conducted a pilot randomized wait-list controlled trial of 8 weeks of yoga (n = 21) versus wait-list control (n = 20) for CIPN in 41 breast and gynecological cancer survivors with persistent moderate to severe CIPN. HRQOL endpoints were Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI), and Insomnia Severity Index (ISI). The Treatment Expectancy Scale (TES) was administered at baseline. We estimated mean changes and 95% confidence intervals (CIs) from baseline to weeks 8 and 12 and compared arms using constrained linear mixed models.
RESULTS


At week 8, HADS anxiety scores decreased -1.61 (-2.75, -0.46) in the yoga arm and -0.32 (-1.38, 0.75) points in the wait-list control arm (p = 0.099). At week 12, HADS anxiety scores decreased -1.42 (-2.57, -0.28) in yoga compared to an increase of 0.46 (-0.60, 1.53) in wait-list control (p = 0.017). There were no significant differences in HADS depression, BFI, or ISI scores between yoga and wait-list control. Baseline TES was significantly higher in yoga than in wait-list control (14.9 vs. 12.7, p = 0.019). TES was not associated with HADS anxiety reduction and HADS anxiety reduction was not associated with CIPN pain reduction.
CONCLUSIONS


Yoga may reduce anxiety in patients with CIPN. Future studies are needed to confirm these findings.
CLINICAL TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Identifier: NCT03292328.",2021,"There were no significant differences in HADS depression, BFI, or ISI scores between yoga and wait-list control.","['patients with chemotherapy-induced peripheral neuropathy (CIPN', 'cancer survivors with chemotherapy-induced peripheral neuropathy', '41 breast and gynecological cancer survivors with persistent moderate to severe CIPN', 'patients with CIPN']","['yoga (n\xa0=\xa021) versus wait-list control (n\xa0=\xa020) for CIPN', 'TES']","['HADS anxiety reduction and HADS anxiety reduction', 'Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI), and Insomnia Severity Index (ISI', 'anxiety', 'Treatment Expectancy Scale (TES', 'HADS anxiety scores', 'Baseline TES', 'health-related quality of life (HRQOL) outcomes', 'HADS depression, BFI, or ISI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}]",,0.0544251,"There were no significant differences in HADS depression, BFI, or ISI scores between yoga and wait-list control.","[{'ForeName': 'W Iris', 'Initials': 'WI', 'LastName': 'Zhi', 'Affiliation': 'Breast Medicine Service, Solid Tumor Division, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Raymond E', 'Initials': 'RE', 'LastName': 'Baser', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Lillian M', 'Initials': 'LM', 'LastName': 'Zhi', 'Affiliation': 'Ward Melville High School, East Setauket, NY, USA.'}, {'ForeName': 'Dristi', 'Initials': 'D', 'LastName': 'Talukder', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Qing S', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Paul', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Patterson', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Piulson', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Seluzicki', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Galantino', 'Affiliation': 'School of Health Sciences, Stockton University, Galloway, NJ, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Bao', 'Affiliation': 'Breast Medicine Service, Solid Tumor Division, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Cancer medicine,['10.1002/cam4.4098']
768,34213061,EMA Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma.,"Isatuximab is a monoclonal antibody that binds to the human CD38 antigen. On May 30, 2020, a marketing authorization valid through the European Union (EU) was issued for isatuximab in combination with pomalidomide and dexamethasone (IsaPd) for the treatment of adult patients with relapsed and refractory (RR) multiple myeloma (MM). The recommended dose of isatuximab was 10 mg/kg, administered intravenously weekly at cycle 1 and then biweekly in subsequent 28-day cycles. Isatuximab was evaluated in a phase III, open-label, multicenter, randomized trial that randomly allocated IsaPd versus pomalidomide plus dexamethasone (Pd) to adult patients with RR MM. The primary endpoint of the trial was progression-free survival, as assessed by an independent review committee, which was superior for the IsaPd arm (hazard ratio, 0.596; 95% confidence interval, 0.436-0.814; p = .001) compared with the Pd arm. Treatment with IsaPd led to higher incidences of treatment-related adverse events (AEs), grade ≥ 3 AEs, and serious AEs compared with Pd treatment. Most frequently observed AEs that occurred more often in the IsaPd arm were infusion-related reactions, infections, respiratory AEs, neutropenia (including neutropenic complications), and thrombocytopenia. The aim of this article is to summarize the scientific review of the application leading to regulatory approval in the EU. IMPLICATIONS FOR PRACTICE: Isatuximab was approved in the European Union, in combination with pomalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have already received therapy but whose disease did not respond or relapsed afterward. The addition of isatuximab resulted in a clinically meaningful and significant prolongation of the time from treatment initiation to further disease relapse or patient's death. The safety profile was considered acceptable, and the benefit-risk ratio was determined to be positive.",2021,"Treatment with IsaPd led to higher incidences of treatment-related adverse events (AEs), grade ≥3 AEs and serious AEs compared to Pd treatment.","['patients with multiple myeloma who have already received therapy, but the disease did not respond or relapsed afterwards', 'adult patients with relapsed and refractory (RR) multiple myeloma (MM', 'Adult Patients with Relapsed and Refractory Multiple Myeloma', 'adult patients with RR MM']","['pomalidomide and dexamethasone', 'IsaPd', 'IsaPd vs. pomalidomide plus dexamethasone (Pd', 'Pomalidomide and Dexamethasone', 'isatuximab', 'isatuximab in combination with pomalidomide and dexamethasone (IsaPd']","['infusion related reactions, infections, respiratory AEs, neutropenia (including neutropenic complications), and thrombocytopenia', 'benefit-risk ratio', 'progression-free survival (PFS), as assessed by an independent review committee (IRC', 'treatment-related adverse events (AEs), grade ≥3 AEs and serious AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4330502', 'cui_str': 'isatuximab'}]","[{'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.28333,"Treatment with IsaPd led to higher incidences of treatment-related adverse events (AEs), grade ≥3 AEs and serious AEs compared to Pd treatment.","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Delgado', 'Affiliation': 'Oncology and Hematology Office, European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Zienowicz', 'Affiliation': 'Oncology and Hematology Office, European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Paula Boudewina', 'Initials': 'PB', 'LastName': 'van Hennik', 'Affiliation': 'Committe for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Moreau', 'Affiliation': 'Committe for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gisselbrecht', 'Affiliation': 'Hopital Saint Louis, Paris, France.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Enzmann', 'Affiliation': 'Committe for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'Oncology and Hematology Office, European Medicines Agency, Amsterdam, The Netherlands.'}]",The oncologist,['10.1002/onco.13892']
769,34211101,Photoneuromodulation makes a difficult cognitive task less arduous.,"A positive effect of photoneuromodulation (PNM) has been found on cognitive and emotional functions in healthy populations. However, the hemodynamic changes associated with improved cognitive functions (i.e., memory and executive functions) are unexplored. Therefore, the present study investigated the hemodynamic changes associated with PNM using functional near-infrared spectroscopy (fNIRS). In this experiment, 33 young healthy adults were recruited and randomly assigned to control and experimental groups. A single PNM stimulation was applied to the forehead in the experimental group, while a sham stimulation (same procedure without machine activation) was performed for the control group. Before and after the stimulation, all participants performed an n-back task with 0-and 3-back conditions to assess their working memory function, and their hemodynamic responses during the tasks were measured by fNIRS. A significant group (experimental vs. control) × time (before vs. after PNM) interaction in memory-related frontal activation was found. Specifically, only the experimental group had a significant reduction in frontal hemodynamic levels during the difficult task. Additionally, the memory-related frontal activation was significantly correlated with the immediate and delayed recall of the Rey-Osterrieth Complex Figure Test assessed at baseline. Therefore, PNM may reduce the cognitive efforts needed to complete tasks with high memory loads.",2021,A positive effect of photoneuromodulation (PNM) has been found on cognitive and emotional functions in healthy populations.,"['healthy populations', '33 young healthy adults']",['photoneuromodulation (PNM'],"['memory-related frontal activation', 'frontal hemodynamic levels', 'cognitive functions (i.e., memory and executive functions']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",33.0,0.0303159,A positive effect of photoneuromodulation (PNM) has been found on cognitive and emotional functions in healthy populations.,"[{'ForeName': 'Agnes S', 'Initials': 'AS', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, China. aschan@cuhk.edu.hk.'}, {'ForeName': 'Tsz-Lok', 'Initials': 'TL', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, China.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Hamblin', 'Affiliation': 'Laser Research Centre, Faculty of Health Science, University of Johannesburg, Doornfontein, 2028, South Africa.'}, {'ForeName': 'Mei-Chun', 'Initials': 'MC', 'LastName': 'Cheung', 'Affiliation': 'Department of Social Work, The Chinese University of Hong Kong, Hong Kong, China.'}]",Scientific reports,['10.1038/s41598-021-93228-2']
770,34214499,"Comparison of Ischial Containment and Subischial Sockets on Comfort, Function, Quality of Life, and Satisfaction With Device in Persons With Unilateral Transfemoral Amputation: A Randomized Crossover Trial.","OBJECTIVE


To compare comfort and functional performance of the Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket with the ischial containment (IC) socket in persons with unilateral transfemoral amputation.
DESIGN


Randomized crossover trial with two 7-week periods.
SETTING


Private prosthetic clinics and university research laboratory.
PARTICIPANTS


A total of 30 enrolled (N=30); 25 participants completed the study with full (n=18) or partial data (n=7).
INTERVENTIONS


Two custom-fabricated sockets (IC and NU-FlexSIV), worn full-time for 7 weeks, with testing at 1, 4, and 7 weeks after socket delivery.
MAIN OUTCOME MEASURES


The primary outcome was change in Socket Comfort Score (SCS) at 7 weeks. Secondary outcomes at 7 weeks included the Orthotic and Prosthetic Users' Survey (OPUS) to assess lower extremity functional status, health-related quality of life, and satisfaction with device, as well as the 5-Times Rapid Sit-to-Stand Test, Four Square Step Test, and T-Test of Agility to assess functional performance.
RESULTS


At 7 weeks, the mean SCS for IC (7.0±1.7) and NU-FlexSIV (8.4±1.1) Sockets were significantly different (P<.001; 95% confidence interval, 0.8-2.3). Results from a linear mixed-effects model, accounting for data from all time points, indicated that the SCS was 1.7 (SE=0.45) points higher for the NU-FlexSIV Socket (P<.001). For the secondary outcomes, only OPUS satisfaction with device was significantly better in the NU-FlexSIV Socket after accounting for all data points.
CONCLUSIONS


The results suggest that after 7 weeks' accommodation, the NU-FlexSIV Socket was more comfortable and led to greater satisfaction with device than the IC socket in persons with unilateral transfemoral amputation and K3/K4 mobility. Other patient-reported outcomes and function were no different between sockets.",2021,"Sockets were significantly different (p < 0.001, 95% CI of difference = [0.8, 2.3]).","['30 enrolled; 25 completed the study with full (n=18) or partial data (n=7', 'Private prosthetic clinics and university research laboratory', 'Persons with Unilateral Transfemoral Amputation', 'persons with unilateral transfemoral amputation']","['Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket to the Ischial Containment (IC) Socket', 'Two custom-fabricated sockets (IC and NU-FlexSIV', 'Ischial Containment and Sub-Ischial Sockets']","['Comfort, Function, Quality-of-Life and Satisfaction with Device', 'change in Socket Comfort Score (SCS', 'OPUS satisfaction with device', ""Orthotic and Prosthetic Users' Survey (OPUS) to assess lower extremity functional status, health-related quality-of-life, and satisfaction with device, as well as the 5-Times Rapid Sit-to-Stand Test, Four Square Step Test, and T-Test of Agility to assess functional performance""]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022886', 'cui_str': 'Laboratory Research'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0002691', 'cui_str': 'Amputation above-knee'}]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0162343', 'cui_str': 'Customs'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}]",30.0,0.234766,"Sockets were significantly different (p < 0.001, 95% CI of difference = [0.8, 2.3]).","[{'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Fatone', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Northwestern University, Feinberg School of Medicine, Chicago, IL. Electronic address: s-fatone@northwestern.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Caldwell', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Northwestern University, Feinberg School of Medicine, Chicago, IL; Scheck and Siress Prosthetics and Orthotics, Chicago, IL; Hanger Clinic, Austin, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Angelico', 'Affiliation': 'Scheck and Siress Prosthetics and Orthotics, Chicago, IL; Hanger Clinic, Austin, TX.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Stine', 'Affiliation': 'Jesse Brown VA Medical Center, Chicago, IL.'}, {'ForeName': 'Kwang-Youn', 'Initials': 'KY', 'LastName': 'Kim', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Gard', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Northwestern University, Feinberg School of Medicine, Chicago, IL; Jesse Brown VA Medical Center, Chicago, IL.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Oros', 'Affiliation': 'Scheck and Siress Prosthetics and Orthotics, Chicago, IL; Hanger Clinic, Austin, TX.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.05.016']
771,34214475,Inhaled treprostinil and forced vital capacity in patients with interstitial lung disease and associated pulmonary hypertension: a post-hoc analysis of the INCREASE study.,"BACKGROUND


INCREASE was a randomised, placebo-controlled, phase 3 trial that evaluated inhaled treprostinil in patients with interstitial lung disease (ILD) and associated pulmonary hypertension. Treprostinil improved exercise capacity from baseline to week 16, assessed with the use of a 6-min walk test, compared with placebo. Improvements in forced vital capacity (FVC) were also reported. The aim of this post-hoc analysis was to further characterise the effects of inhaled treprostinil on FVC in the overall study population and in various subgroups of interest.
METHODS


In this post-hoc analysis, we evaluated FVC changes in the overall study population and in various subgroups defined by cause of disease or baseline clinical parameters. The study population included patients aged 18 years and older who had a diagnosis of ILD based on evidence of diffuse parenchymal lung disease on chest CT done within 6 months before random assignment (not centrally adjudicated). All analyses were done on the intention-to-treat population, defined as individuals who were randomly assigned and received at least one dose of study drug. The INCREASE study is registered with ClinicalTrials.gov, NCT02630316.
FINDINGS


Between Feb 3, 2017, and Aug 30, 2019, 326 patients were enrolled in the INCREASE trial. Inhaled treprostinil was associated with a placebo-corrected least squares mean improvement in FVC of 28·5 mL (SE 30·1; 95% CI -30·8 to 87·7; p=0·35) at week 8 and 44·4 mL (35·4; -25·2 to 114·0; p=0·21) at week 16, with associated percentage of predicted FVC improvements of 1·8% (0·7; 0·4 to 3·2; p=0·014) and 1·8% (0·8; 0·2 to 3·4; p=0·028). Subgroup analysis of patients with idiopathic interstitial pneumonia showed FVC differences of 46·5 mL (SE 39·9; 95% CI -32·5 to 125·5; p=0·25) at week 8 and 108·2 mL (46·9; 15·3 to 201·1; p=0·023) at week 16. Analysis of patients with idiopathic pulmonary fibrosis showed FVC differences of 84·5 mL (52·7; -20·4 to 189·5; p=0·11) at week 8 and 168·5 mL (64·5; 40·1 to 297·0; p=0·011) at week 16. The most frequent adverse events included cough, headache, dyspnoea, dizziness, nausea, fatigue, and diarrhoea.
INTERPRETATION


In patients with ILD and associated pulmonary hypertension, inhaled treprostinil was associated with improvements in FVC versus placebo at 16 weeks. This difference was most evident in patients with idiopathic interstitial pneumonia, particularly idiopathic pulmonary fibrosis. Inhaled treprostinil appears to be a promising therapy for idiopathic pulmonary fibrosis that warrants further investigation in a prospective, randomised, placebo-controlled study.
FUNDING


United Therapeutics Corporation.",2021,(52·7; -20·4 to 189·5; p=0·11) at week 8 and 168·5,"['Between Feb 3, 2017, and Aug 30, 2019', 'patients aged 18 years and older who had a diagnosis of ILD based on evidence of diffuse parenchymal lung disease on chest CT done within 6 months before random assignment (not centrally adjudicated', 'patients with interstitial lung disease (ILD) and associated pulmonary hypertension', 'patients with idiopathic interstitial pneumonia, particularly idiopathic pulmonary fibrosis', 'patients with idiopathic pulmonary fibrosis showed FVC differences of 84·5 mL', 'patients with interstitial lung disease and associated pulmonary hypertension', '326 patients were enrolled in the INCREASE trial']","['treprostinil', 'Inhaled treprostinil', 'Treprostinil', 'mL', 'placebo', 'inhaled treprostinil']","['exercise capacity', 'forced vital capacity (FVC', 'pulmonary hypertension', 'cough, headache, dyspnoea, dizziness, nausea, fatigue, and diarrhoea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0085786', 'cui_str': 'Diffuse interstitial pulmonary fibrosis'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1145760', 'cui_str': 'Treprostinil'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",326.0,0.47,(52·7; -20·4 to 189·5; p=0·11) at week 8 and 168·5,"[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': 'Advanced Lung Disease and Transplant Program, Inova Fairfax Hospital, Falls Church, VA, USA. Electronic address: steven.nathan@inova.org.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Waxman', 'Affiliation': ""Pulmonary and Critical Care Medicine, Department of Internal Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Sudarshan', 'Initials': 'S', 'LastName': 'Rajagopal', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Case', 'Affiliation': 'Piedmont Healthcare, Austell, GA, USA.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Johri', 'Affiliation': 'Pulmonary Associates of Richmond, Richmond, VA, USA.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'DuBrock', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary and Critical Care, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'De La Zerda', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, University of Miami Health System, Miami, FL, USA.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Sahay', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'Advanced Lung Disease and Transplant Program, Inova Fairfax Hospital, Falls Church, VA, USA.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Melendres-Groves', 'Affiliation': 'Pulmonary & Critical Care Division, University of New Mexico, 1 University of New Mexico, DoIM MSC10-5550, Albuquerque, NM, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'United Therapeutics Corporation, Research Triangle Park, NC, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Shen', 'Affiliation': 'United Therapeutics Corporation, Research Triangle Park, NC, USA.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Edwards', 'Affiliation': 'United Therapeutics Corporation, Research Triangle Park, NC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nelsen', 'Affiliation': 'United Therapeutics Corporation, Research Triangle Park, NC, USA.'}, {'ForeName': 'Victor F', 'Initials': 'VF', 'LastName': 'Tapson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00165-X']
772,34218429,Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies.,"BACKGROUND


Psoriatic arthritis (PsA) is a chronic, heterogeneous, immune-mediated disease manifesting as a spectrum of possible inflammatory signs and symptoms. Clinicians need therapeutic choices that work across all active PsA disease domains, as well as practical information about efficacy of available treatments for individual domains in specific groups of patients. The objective of this study was to evaluate the effect of prior tumor necrosis factor inhibitor (TNFi) exposure on the efficacy of secukinumab across PsA core domains.
METHODS


Data were pooled from 2049 participants with PsA in four phase 3 studies (FUTURE 2-5). Efficacy at week 16 was evaluated for each GRAPPA-OMERACT PsA core domain using nonresponder imputation for musculoskeletal disease activity and Psoriasis Area and Severity Index scores or as-observed data for other outcomes. For each measure, comparisons with placebo were made separately in the TNFi-naive and TNFi-inadequate responder/intolerant (TNF-IR) cohorts.
RESULTS


Treatment with secukinumab improved PsA disease activity across all disease domains regardless of previous TNFi use, although TNFi-naive patients experienced numerically greater benefits in most outcomes. Among patients treated with secukinumab 300 mg, 41.5% and 24.4% of TNFi-naive patients (P < 0.05 vs placebo) and 18.6% and 9.0% of TNF-IR patients (nonsignificant vs placebo) experienced resolution in 66 swollen and 68 tender joint counts, respectively; additionally, 37.2% of TNFi-naive patients and 24.2% of TNF-IR patients achieved complete resolution of psoriasis at week 16 (all P < 0.05 vs placebo). Secukinumab effect sizes were generally larger in TNFi-naive vs TNF-IR patients for musculoskeletal and patient-reported domains.
CONCLUSIONS


Secukinumab demonstrated efficacy vs placebo across GRAPPA-OMERACT PsA core domains. Higher responses among TNFi-naive vs TNF-IR patients suggest that secukinumab should be considered for first-line use in PsA.",2021,"Secukinumab effect sizes were generally larger in TNFi-naive vs TNF-IR patients for musculoskeletal and patient-reported domains.
","['Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use', '2049 participants with PsA in four phase\xa03 studies (FUTURE\xa02-5']","['prior tumor necrosis factor inhibitor (TNFi', 'secukinumab', 'placebo']","['musculoskeletal disease activity and Psoriasis Area and Severity Index scores', 'PsA disease activity', 'complete resolution of psoriasis', 'Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",2049.0,0.214598,"Secukinumab effect sizes were generally larger in TNFi-naive vs TNF-IR patients for musculoskeletal and patient-reported domains.
","[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Orbai', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, MFL Center Tower, Suite 4100, 5200 Eastern Ave, Baltimore, MD, 21224, USA. aorbai1@jhmi.edu.'}, {'ForeName': 'M Elaine', 'Initials': 'ME', 'LastName': 'Husni', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'Krembil Research Institute, Toronto Western Hospital and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ying Ying', 'Initials': 'YY', 'LastName': 'Leung', 'Affiliation': 'Duke-NUS Medical School, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Siebert', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tillett', 'Affiliation': 'University of Bath, Bath, UK.'}, {'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'Vis', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chambenoit', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St, Joseph Health and University of Washington, Seattle, WA, USA.'}]",Rheumatology and therapy,['10.1007/s40744-021-00337-5']
773,34224590,"Results from the blood donor competence, autonomy, and relatedness enhancement (blood donor CARE) randomized trial.","BACKGROUND


This study aimed to promote competence, autonomy, and relatedness among first-time whole blood donors to enhance intrinsic motivation and increase retention.
STUDY DESIGN AND METHODS


Using a full factorial design, first-time donors (N = 2002) were randomly assigned to a no-treatment control condition or to one of seven intervention conditions designed to promote donation competence, autonomy, relatedness, a combination of two (e.g., competence and autonomy), or all three constructs. Participants completed donor motivation measures before the intervention and 6 weeks later, and subsequent donation attempts were assessed for 1 year.
RESULTS


There was no significant group difference in the frequency of donation attempts or in the number of days to return. Significant effects of group were observed for 10 of the 12 motivation measures, although follow-up analyses revealed significant differences from the control group were restricted to interventions that included an autonomy component. Path analyses confirmed direct associations between interventions involving autonomy and donor motivation, and indirect mediation of donation attempts via stronger donation intentions and lower donation anxiety.
CONCLUSION


Among young, first-time, whole blood donors, brief interventions that include support for donor autonomy were associated with direct effects on donor motivation and indirect, but small, effects on subsequent donation behavior.",2021,"Path analyses confirmed direct associations between interventions involving autonomy and donor motivation, and indirect mediation of donation attempts via stronger donation intentions and lower donation anxiety.
",['N\xa0=\xa02002'],"['no-treatment control condition or to one of seven intervention conditions designed to promote donation competence, autonomy, relatedness, a combination of two (e.g., competence and autonomy']",['frequency of donation attempts'],[],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}]",2002.0,0.0320636,"Path analyses confirmed direct associations between interventions involving autonomy and donor motivation, and indirect mediation of donation attempts via stronger donation intentions and lower donation anxiety.
","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Janis L', 'Initials': 'JL', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Lina K', 'Initials': 'LK', 'LastName': 'Himawan', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Fox', 'Affiliation': ""Center for Biobehavioral Health, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Irina E', 'Initials': 'IE', 'LastName': 'Livitz', 'Affiliation': 'Department of Psychiatry, Cambridge Health Alliance, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Ankawi', 'Affiliation': 'VA Connecticut, West Haven, Connecticut, USA.'}, {'ForeName': 'P Maxwell', 'Initials': 'PM', 'LastName': 'Slepian', 'Affiliation': 'Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Kowalsky', 'Affiliation': 'Department of Psychology, Ohio State University, Newark, Ohio, USA.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Duffy', 'Affiliation': 'New York Blood Center, New York, New York, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Kessler', 'Affiliation': 'New York Blood Center, New York, New York, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rebosa', 'Affiliation': 'New York Blood Center, New York, New York, USA.'}, {'ForeName': 'Shiraz', 'Initials': 'S', 'LastName': 'Rehmani', 'Affiliation': 'New York Blood Center, New York, New York, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Frye', 'Affiliation': 'City University of New York School of Medicine, Community Health and Social Medicine, New York, New York, USA.'}, {'ForeName': 'Beth H', 'Initials': 'BH', 'LastName': 'Shaz', 'Affiliation': 'Department of Pathology, Duke University School of Medicine, Durham, North Carolina, USA.'}]",Transfusion,['10.1111/trf.16577']
774,34228019,Pragmatic Considerations in Incorporating Stakeholder Engagement Into a Palliative Care Transitions Study.,"BACKGROUND


Stakeholder involvement in health care research has been shown to improve research development, processes, and dissemination. The literature is developing on stakeholder engagement methods and preliminarily validated tools for evaluating stakeholder level of engagement have been proposed for specific stakeholder groups and settings.
OBJECTIVES


This paper describes the methodology for engaging a Study Advisory Committee (SAC) in research and reports on the use of a stakeholder engagement survey for measuring level of engagement.
METHODS


Stakeholders with previous research connections were recruited to the SAC during the planning process for a multicenter randomized control clinical trial, which is ongoing at the time of this writing. All SAC meetings undergo qualitative analysis, while the Stakeholder Engagement Survey instrument developed by the Patient-Centered Outcomes Research Institute (PCORI) is distributed annually for quantitative evaluation.
RESULTS


The trial's SAC is composed of 18 members from 3 stakeholder groups: patients and their caregivers; patient advocacy organizations; and health care payers. After an initial in-person meeting, the SAC meets quarterly by telephone and annually in-person. The SAC monitors research progress and provides feedback on all study processes. The stakeholder engagement survey reveals improved engagement over time as well as continued challenges.
CONCLUSIONS


Stakeholder engagement in the research process has meaningfully contributed to the study design, patient recruitment, and preliminary analysis of findings.",2021,"The stakeholder engagement survey reveals improved engagement over time as well as continued challenges.
","['18 members from 3 stakeholder groups: patients and their caregivers; patient advocacy organizations; and health care payers', 'Stakeholders with previous research connections']",[],[],"[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030674', 'cui_str': 'Acting as individual patient advocate'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0449379', 'cui_str': 'Connection'}]",[],[],18.0,0.1157,"The stakeholder engagement survey reveals improved engagement over time as well as continued challenges.
","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'de Forcrand', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Flannery', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, New York University School of Medicine.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, New York University School of Medicine.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Reddy Pidatala', 'Affiliation': 'American Cancer Society, New York, NY.'}, {'ForeName': 'Romilla', 'Initials': 'R', 'LastName': 'Batra', 'Affiliation': 'Senior Care Action Network (SCAN) Health Plan, Long Beach.'}, {'ForeName': 'Juanita', 'Initials': 'J', 'LastName': 'Booker-Vaughns', 'Affiliation': 'Charles R. Drew University of Medicine & Science, Los Angeles.'}, {'ForeName': 'Garrett K', 'Initials': 'GK', 'LastName': 'Chan', 'Affiliation': 'Center for Education and Professional Development, Stanford Health Care, Stanford, CA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dunn', 'Affiliation': 'American Heart Association, Dallas, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Galvin', 'Affiliation': 'The Blackstone Group, New York, NY.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Hopkins', 'Affiliation': 'The Phoenix Group Foundation, Milwaukee, WI.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Isaacs', 'Affiliation': 'Department of Emergency Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Constance L', 'Initials': 'CL', 'LastName': 'Kizzie-Gillett', 'Affiliation': ""Lillie's Circle of Care, Elgin, IL.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Maguire', 'Affiliation': 'Cambia Health Solutions, Portland, OR.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Navarro', 'Affiliation': 'Charles R. Drew University of Medicine & Science, Los Angeles.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Rosini', 'Affiliation': 'University of Florida Shands Hospital, Gainesville, FL.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Vaughan', 'Affiliation': 'Patient Advocacy, Fairfax County, VA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Welsh', 'Affiliation': 'Hospice and Palliative Nurses Foundation, Pittsburgh, PA.'}, {'ForeName': 'Pluscedia', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Charles R. Drew University of Medicine & Science, Los Angeles.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Young-Brinn', 'Affiliation': 'Charles R. Drew University of Medicine & Science, Los Angeles.'}, {'ForeName': 'Corita R', 'Initials': 'CR', 'LastName': 'Grudzen', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, New York University School of Medicine.'}]",Medical care,['10.1097/MLR.0000000000001583']
775,34228018,Short-term Focused Feedback: A Model to Enhance Patient Engagement in Research and Intervention Delivery.,"BACKGROUND


Our grant from the Patient-Centered Outcomes Research Institute (PCORI) focused on the use of nurse home visits postdischarge for primarily pediatric hospital medicine patients. While our team recognized the importance of engaging parents and other stakeholders in our study, our project was one of the first funded to address transitions of care issues in patients without chronic illness; little evidence existed about how to engage acute stakeholders longitudinally.
OBJECTIVE


This manuscript describes how we used both a short-term focused feedback model and longitudinal engagement methods to solicit input from parents, home care nurses, and other stakeholders throughout our 3-year study.
RESULTS


Short-term focused feedback allowed the study team to collect feedback from hundreds of stakeholders. Initially, we conducted focus groups with parents with children recently discharged from the hospital. We used this feedback to modify our nurse home visit intervention, then used quality improvement methods with continued short-term focus feedback from families and nurses delivering the visits to adjust the visit processes and content. We also used their feedback to modify the outcome collection. Finally, during the randomized controlled trial, we added a parent to the study team to provide longitudinal input, as well as continued to solicit short-term focused feedback to increase recruitment and retention rates.
CONCLUSION


Research studies can benefit from soliciting short-term focused feedback from many stakeholders; having this variety of perspectives allows for many voices to be heard, without placing an undue burden on a few stakeholders.",2021,"BACKGROUND


Our grant from the Patient-Centered Outcomes Research Institute (PCORI) focused on the use of nurse home visits postdischarge for primarily pediatric hospital medicine patients.","['parents with children recently discharged from the hospital', 'patients without chronic illness', 'primarily pediatric hospital medicine patients']",['Short-term Focused Feedback'],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",[],,0.0343785,"BACKGROUND


Our grant from the Patient-Centered Outcomes Research Institute (PCORI) focused on the use of nurse home visits postdischarge for primarily pediatric hospital medicine patients.","[{'ForeName': 'Hadley', 'Initials': 'H', 'LastName': 'Sauers-Ford', 'Affiliation': 'Division of Hospital Medicine.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Statile', 'Affiliation': 'Division of Hospital Medicine.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Auger', 'Affiliation': 'Division of Hospital Medicine.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wade-Murphy', 'Affiliation': 'Department of Patient Services.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Gold', 'Affiliation': ""Home Care Services, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Simmons', 'Affiliation': 'Division of Hospital Medicine.'}, {'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Shah', 'Affiliation': 'Division of Hospital Medicine.'}]",Medical care,['10.1097/MLR.0000000000001588']
776,34228017,Methodological Challenges and Statistical Approaches in the COMprehensive Post-Acute Stroke Services Study.,"BACKGROUND


The COMprehensive Post-Acute Stroke Services study was a cluster-randomized pragmatic trial designed to evaluate a comprehensive care transitions model versus usual care. The data collected during this trial were complex and analysis methodology was required that could simultaneously account for the cluster-randomized design, missing patient-level covariates, outcome nonresponse, and substantial nonadherence to the intervention.
OBJECTIVE


The objective of this study was to discuss an array of complementary statistical methods to evaluate treatment effectiveness that appropriately addressed the challenges presented by the complex data arising from this pragmatic trial.
METHODS


We utilized multiple imputation combined with inverse probability weighting to account for missing covariate and outcome data in the estimation of intention-to-treat effects (ITT). The ITT estimand reflects the effectiveness of assignment to the COMprehensive Post-Acute Stroke Services intervention compared with usual care (ie, it does not take into account intervention adherence). Per-protocol analyses provide complementary information about the effect of treatment, and therefore are relevant for patients to inform their decision-making. We describe estimation of the complier average causal effect using an instrumental variables approach through 2-stage least squares estimation. For all preplanned analyses, we also discuss additional sensitivity analyses.
DISCUSSION


Pragmatic trials are well suited to inform clinical practice. Care should be taken to proactively identify the appropriate balance between control and pragmatism in trial design. Valid estimation of ITT and per-protocol effects in the presence of complex data requires application of appropriate statistical methods and concerted efforts to ensure high-quality data are collected.",2021,"The ITT estimand reflects the effectiveness of assignment to the COMprehensive Post-Acute Stroke Services intervention compared with usual care (ie, it does not take into account intervention adherence).",[],[],[],[],[],[],,0.0678216,"The ITT estimand reflects the effectiveness of assignment to the COMprehensive Post-Acute Stroke Services intervention compared with usual care (ie, it does not take into account intervention adherence).","[{'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Psioda', 'Affiliation': 'Department of Biostatistics, Collaborative Studies Coordinating Center.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Xenakis', 'Affiliation': 'Department of Genetics, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Ralph B', 'Initials': 'RB', 'LastName': ""D'Agostino"", 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}]",Medical care,['10.1097/MLR.0000000000001580']
777,34210824,Impact of Renal Impairment on Intensive Blood-Pressure-Lowering Therapy and Outcomes in Intracerebral Hemorrhage: Results From ATACH-2.,"BACKGROUND AND OBJECTIVE


The clinical effect of renal impairment on intracerebral hemorrhage (ICH) is unknown. This study sought to assess whether estimated glomerular filtration rate (eGFR) affects clinical outcomes or modifies the efficacy of intensive systolic blood pressure (BP) control (target, 110-139 mm Hg) against the standard (target, 140-179 mm Hg) among patients with ICH.
METHODS


We conducted post hoc analyses of ATACH-2, a randomized, 2-group, open-label trial. The baseline eGFR of each eligible patient was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation. The outcome of interest was death or disability at 90 days. Multivariate logistic regression models were used for analysis.
RESULTS


Among the 1,000 patients randomized, 974 were analyzed. The median baseline eGFR was 88 (interquartile range, 68, 99) mL/min/1.73 m 2 ; 451 (46.3%), 363 (37.3%), and 160 (16.4%) patients had baseline eGFR values of ≥90, 60-89, and <60 mL/min/1.73 m 2 , respectively. Compared with normal eGFR (≥90 mL/min/1.73 m 2 ), higher odds of death or disability were noted among those with eGFR values of <60 mL/min/1.73 m 2  (adjusted odds ratio [OR], 2.02; 95% confidence interval [CI], 1.25-3.26) but not among those with eGFR values of 60-89 mL/min/1.73 m 2  (OR, 1.01; 95% CI, 0.70-1.46). The odds of death or disability were significantly higher in the intensive arm among patients with decreased eGFR; the ORs were 0.89 (95% CI, 0.55-1.44), 1.13 (0.68-1.89), and 3.60 (1.47-8.80) in patients with eGFR values of ≥90, 60-89, and <60 mL/min/1.73 m 2 , respectively ( p  for interaction = 0.02).
DISCUSSION


Decreased eGFR is associated with unfavorable outcomes following ICH. The statistically significant interaction between the eGFR group and treatment assignment raised safety concerns for the intensive BP-lowering therapy among patients with renal impairment.
TRIAL REGISTRATION INFORMATION


Clinicaltrials.gov identifier: NCT01176565.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that in spontaneous ICH, decreased eGFR identifies patients at risk of death or disability following intensive BP control.",2021,"Compared with normal eGFR (≥90 ml/min/1.73 m 2 ), higher odds of death or disability were noted among those with eGFR values of <60 ml/min/1.73 m 2  (adjusted odds ratio (OR) 2.02, 95% confidence interval (CI) 1.25-3.26) but not among those with eGFR values of 60-89 ml/","['patients with ICH', 'Intracerebral Hemorrhage', 'patients with renal impairment', '1000 patients randomized, 974 were analyzed']",['intensive systolic blood pressure (BP) control'],"['higher odds of death or disability', 'median baseline eGFR', 'odds of death or disability', 'intracerebral hemorrhage (ICH', 'death or disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}]",1000.0,0.23267,"Compared with normal eGFR (≥90 ml/min/1.73 m 2 ), higher odds of death or disability were noted among those with eGFR values of <60 ml/min/1.73 m 2  (adjusted odds ratio (OR) 2.02, 95% confidence interval (CI) 1.25-3.26) but not among those with eGFR values of 60-89 ml/","[{'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Fukuda-Doi', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Doi', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Miwa', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Ishigami', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Shiozawa', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Omae', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ihara', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia. toyoda@ncvc.go.jp.'}]",Neurology,['10.1212/WNL.0000000000012442']
778,34220712,"The Role of Traditional Chinese Formula Ding-Kun Pill (DKP) in Expected Poor Ovarian Response Women (POSEIDON Group 4) Undergoing  In Vitro  Fertilization-Embryo Transfer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.","Objective


The primary objective of the study was to assess traditional Chinese formula DKP supplementation in terms of efficacy and safety on reproductive outcomes of expected poor ovarian responder (POR, POSEIDON Group 4) undergoing  in vitro  fertilization-embryo transfer (IVF-ET).
Design Setting and Participants


Women eligible for IVF-ET were invited to participate in this randomized, double-blind, placebo-controlled, superiority trial at academic fertility centers of ten public hospitals in Chinese Mainland. A total of 462 patients (35-44 years) equally divided between DKP and placebo groups with antral follicle count (AFC) <5 or anti-müllerian hormone (AMH) <1.2 ng/ml were randomized.
Interventions


All participants were given DKP or 7 g placebo twice daily on the previous menstrual cycle day 5 until oocyte retrieval, which took approximately 5 to 6 weeks.
Main Outcome Measure


The primary outcome was the ongoing pregnancy defined as more than 20 gestational weeks of an intrauterine living fetus confirmed by pelvic ultrasonography.
Results


Demographic characteristics were equally distributed between the study populations. Intention-to-treat (ITT) analysis revealed that ongoing pregnancy rate (OPR) was not significantly different between DKP and placebo groups [26.4% (61/231) versus 24.2% (56/231); relative risk (RR) 1.09, 95% confidence interval (CI) 0.80 to 1.49,  P  = 0.593]. No significant differences between groups were observed for the secondary outcomes. The additional per protocol (PP) analysis was in line with ITT results: OPR in DKP group was 27.2% (61/224) versus 24.1% (55/228) in placebo group [RR 1.13, 95%CI (0.82 to 1.55),  P  = 0.449]. After subgroup analysis the findings concluded that POR population of 35-37 years had a significantly higher OPR after 5-6 weeks of oral DKP (41.8%, 33/79) versus placebo (25.4%, 18/71) [RR 1.65, 95% CI (1.02 to 2.65),  P  = 0.034,  P  for interaction = 0.028].
Conclusion


This well-designed randomized controlled trial (RCT) offers new high-quality evidence to supplement existing retrospective literature concerning DKP performance in expected PORs. DKP could be recommended as a safe and natural remedy for expected PORs (aged 35-37 years) who fulfill the POSEIDON group 4 criteria. However, additional interventional clinical studies are undoubtedly required to be conducted in the future to validate this hypothesis.
Clinical Trial Registration


www.chictr.org.cn, identifier ChiCTR1900026614.",2021,"Intention-to-treat (ITT) analysis revealed that ongoing pregnancy rate (OPR) was not significantly different between DKP and placebo groups [26.4% (61/231) versus 24.2% (56/231); relative risk (RR) 1.09, 95% confidence interval (CI) 0.80 to 1.49,  P  = 0.593].","['462 patients (35-44 years) equally divided between DKP and placebo groups with antral follicle count (AFC) <5 or anti-müllerian hormone (AMH', 'controlled, superiority trial at academic fertility centers of ten public hospitals in Chinese Mainland', 'Group 4) undergoing  in vitro  fertilization-embryo transfer (IVF-ET', 'Expected Poor Ovarian Response Women (POSEIDON Group 4) Undergoing', 'In Vitro  Fertilization-Embryo Transfer', 'Participants\n\n\nWomen eligible for IVF-ET']","['traditional Chinese formula DKP supplementation', 'Placebo', 'placebo', 'DKP', 'Traditional Chinese Formula Ding-Kun Pill (DKP']","['ongoing pregnancy defined as more than 20 gestational weeks of an intrauterine living fetus confirmed by pelvic ultrasonography', 'ongoing pregnancy rate (OPR', 'OPR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4505129', 'cui_str': 'Superiority Trial'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",462.0,0.904016,"Intention-to-treat (ITT) analysis revealed that ongoing pregnancy rate (OPR) was not significantly different between DKP and placebo groups [26.4% (61/231) versus 24.2% (56/231); relative risk (RR) 1.09, 95% confidence interval (CI) 0.80 to 1.49,  P  = 0.593].","[{'ForeName': 'Jing-Yan', 'Initials': 'JY', 'LastName': 'Song', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Dan-Dan', 'Initials': 'DD', 'LastName': 'Gao', 'Affiliation': 'College of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Xian-Ling', 'Initials': 'XL', 'LastName': 'Cao', 'Affiliation': 'College of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Xiang', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Yan-Hua', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Reproductive Medicine Center, Shanxi Maternal and Child Health Care Hospital, Taiyuan, China.'}, {'ForeName': 'Yi-Li', 'Initials': 'YL', 'LastName': 'Teng', 'Affiliation': 'Reproductive Medicine Center, The Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Xiu-Fang', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Hai-Ping', 'Initials': 'HP', 'LastName': 'Liu', 'Affiliation': 'Department of Reproductive Medicine, The 960th Hospital of the PLA Joint Logistics Support Force Jinan, Jinan, China.'}, {'ForeName': 'Fu-Xin', 'Initials': 'FX', 'LastName': 'Wang', 'Affiliation': 'Center of Reproduction and Genetics, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Reproductive Medicine, The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Xu', 'Affiliation': 'Reproductive Medicine Center, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Reproductive Medicine, The Reproductive Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.'}, {'ForeName': 'Xiang-Hong', 'Initials': 'XH', 'LastName': 'Huang', 'Affiliation': 'Reproduction & Genetics Center, Xiangtan Central Hospital, Xiangtan, China.'}, {'ForeName': 'Zhen-Gao', 'Initials': 'ZG', 'LastName': 'Sun', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2021.675997']
779,34224858,Mastiha has efficacy in immune-mediated inflammatory diseases through a microRNA-155 Th17 dependent action.,"Mastiha is a natural nutritional supplement with known anti-inflammatory properties. Non-alcoholic fatty liver disease (NAFLD) and Inflammatory bowel disease (IBD) are immune mediated inflammatory diseases that share common pathophysiological features. Mastiha has shown beneficial effects in both diseases. MicroRNAs have emerged as key regulators of inflammation and their modulation by phytochemicals have been extensively studied over the last years. Therefore, the aim of this study was to investigate whether a common route exists in the anti-inflammatory activity of Mastiha, specifically through the regulation of miRNA levels. Plasma miR-16, miR-21 and miR-155 were measured by Real-Time PCR before and after two double blinded and placebo-controlled randomized clinical trials with Mastiha. In IBD and particularly in ulcerative colitis patients in relapse, miR-155 increased in the placebo group (p = 0.054) whereas this increase was prevented by Mastiha. The mean changes were different in the two groups even after adjusting for age, sex and BMI (p = 0.024 for IBD and p = 0.042). Although the results were not so prominent in NAFLD, miR-155 displayed a downward trend in the placebo group (p = 0.054) whereas the levels did not changed significantly in the Mastiha group in patients with less advanced fibrosis. Our results propose a regulatory role for Mastiha in circulating levels of miR-155, a critical player in T helper-17 (Th17) differentiation and function.",2021,"In IBD and particularly in ulcerative colitis patients in relapse, miR-155 increased in the placebo group (p=0.054) whereas this increase was prevented by Mastiha.",[],['placebo'],"['Plasma miR-16, miR-21 and miR-155', 'relapse, miR-155']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.198795,"In IBD and particularly in ulcerative colitis patients in relapse, miR-155 increased in the placebo group (p=0.054) whereas this increase was prevented by Mastiha.","[{'ForeName': 'Charalampia', 'Initials': 'C', 'LastName': 'Amerikanou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Efstathia', 'Initials': 'E', 'LastName': 'Papada', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Aristea', 'Initials': 'A', 'LastName': 'Gioxari', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Smyrnioudis', 'Affiliation': 'Chios Mastic Gum Growers Association, Chios, Greece.'}, {'ForeName': 'Stamatia-Angeliki', 'Initials': 'SA', 'LastName': 'Kleftaki', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Evdokia', 'Initials': 'E', 'LastName': 'Valsamidou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Bruns', 'Affiliation': 'Sanofi Research and Development, Industriepark Hoechst, D-65926 Frankfurt, Germany.'}, {'ForeName': 'Rajarshi', 'Initials': 'R', 'LastName': 'Banerjee', 'Affiliation': 'Perspectum Ltd, Oxford, UK.'}, {'ForeName': 'Maria Giovanna', 'Initials': 'MG', 'LastName': 'Trivella', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy; Institute of Clinical Physiology National Research Council, Pisa, Italy.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Milic', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Medić-Stojanoska', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia; Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Centre of Vojvodina, Novi Sad, Serbia.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Institute of Clinical Physiology National Research Council, Pisa, Italy.'}, {'ForeName': 'Aimo', 'Initials': 'A', 'LastName': 'Kannt', 'Affiliation': 'Sanofi Research and Development, Industriepark Hoechst, D-65926 Frankfurt, Germany; Fraunhofer Institute of Translational Medicine and Pharmacology ITMP, Frankfurt, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'George V', 'Initials': 'GV', 'LastName': 'Dedoussis', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece. Electronic address: dedousi@hua.gr.'}, {'ForeName': 'Andriana C', 'Initials': 'AC', 'LastName': 'Kaliora', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece. Electronic address: akaliora@hua.gr.'}]",Pharmacological research,['10.1016/j.phrs.2021.105753']
780,34231178,The Hormonal Milieu by Different Labor Induction Methods in Women with Previous Cesarean Section: a Prospective Randomized Controlled Trial.,"The physiological pattern of hormonal and signaling molecules associated with labor induction is not fully clear. We conducted a preliminary study in order to investigate hormonal changes during labor induction in women with previous cesarean section. Eighty-seven women at term, with previous cesarean section, were randomized to undergo induction of labor by breast stimulation or intracervical balloon and compared with spontaneous labor (controls). Maternal serum levels of oxytocin, prostaglandin F2α, prostaglandin E2, prolactin, estradiol, and cortisol were analyzed at 0, 3, and 6 h post-induction initiation. Fetal umbilical cord hormones were measured. No significant difference was found in the induction-to-delivery time or mode of delivery between the induction groups. Maternal serum oxytocin levels decreased to a lesser extent in the breast stimulation group vs. the control group (p=0.003, p<0.001). In the breast stimulation and control groups, prostaglandin E 2  levels increased as labor progressed (p=0.005, 0.002, respectively). Prostaglandin F2α levels decreased over time in the balloon group (p=0.039), but increased in the control group (p=0.037). Both induction methods had similar outcomes. The hormonal studies ascertained the hypothesized mechanisms, with oxytocin level higher during breast stimulation and lower in balloon induction. These observations could help clinicians determine the appropriate method for cervical ripening in women with previous cesarean section. Larger future studies are needed to examine the effect of these hormonal trends on the rate of successful labor induction and complications, such as uterine rupture, in women with previous uterine scars. ClinicalTrials.gov Identifier NCT04244747.",2021,"In the breast stimulation and control groups, prostaglandin E 2  levels increased as labor progressed (p=0.005, 0.002, respectively).","['Eighty-seven women at term, with previous cesarean section', 'women with previous uterine scars', 'Women with Previous Cesarean Section', 'women with previous cesarean section']",['labor by breast stimulation or intracervical balloon and compared with spontaneous labor (controls'],"['labor progressed', 'Prostaglandin F2α levels', 'Maternal serum oxytocin levels', 'induction-to-delivery time or mode of delivery', 'Fetal umbilical cord hormones', 'Maternal serum levels of oxytocin, prostaglandin F2α, prostaglandin E2, prolactin, estradiol, and cortisol']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0269733', 'cui_str': 'Previous caesarean section'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0404330', 'cui_str': 'Breast stimulation'}, {'cui': 'C0444978', 'cui_str': 'Intracervical'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",87.0,0.0442365,"In the breast stimulation and control groups, prostaglandin E 2  levels increased as labor progressed (p=0.005, 0.002, respectively).","[{'ForeName': 'Maya Frank', 'Initials': 'MF', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel. mayaw@gmc.gov.il.'}, {'ForeName': 'Inshirah', 'Initials': 'I', 'LastName': 'Sgayer', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'Asslan', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.'}, {'ForeName': 'Eilam', 'Initials': 'E', 'LastName': 'Palzur', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Shnaider', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bornstein', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-021-00667-3']
781,34229074,"Opioid Specific Effects on Central Processing of Sensation and Pain: A Randomized, Cross-Over, Placebo-Controlled Study.","Moderate to severe pain is often treated with opioids, but central mechanisms underlying opioid analgesia are poorly understood. Findings thus far have been contradictory and none could infer opioid specific effects. This placebo-controlled, randomized, 2-way cross-over, double-blinded study aimed to explore opioid specific effects on central processing of external stimuli. Twenty healthy male volunteers were included and 3 sets of assessments were done at each of the 2 visits: 1) baseline, 2) during continuous morphine or placebo intravenous infusion and 3) during simultaneous morphine + naloxone or placebo infusion. Opioid antagonist naloxone was introduced in order to investigate opioid specific effects by observing which morphine effects are reversed by this intervention. Quantitative sensory testing, spinal nociceptive withdrawal reflexes (NWR), spinal electroencephalography (EEG), cortical EEG responses to external stimuli and resting EEG were measured and analyzed. Longer lasting pain (cold-pressor test - hand in 2° water for 2 minutes, tetanic electrical), deeper structure pain (bone pressure) and strong nociceptive (NWR) stimulations were the most sensitive quantitative sensory testing measures of opioid analgesia. In line with this, the principal opioid specific central changes were seen in NWRs, EEG responses to NWRs and cold-pressor EEG. The magnitude of NWRs together with amplitudes and insular source strengths of the corresponding EEG responses were attenuated. The decreases in EEG activity were correlated to subjective unpleasantness scores. Brain activity underlying slow cold-pressor EEG (1-4Hz) was decreased, whereas the brain activity underlying faster EEG (8-12Hz) was increased. These changes were strongly correlated to subjective pain relief. This study points to evidence of opioid specific effects on perception of external stimuli and the underlying central responses. The analgesic response to opioids is likely a synergy of opioids acting at both spinal and supra-spinal levels of the central nervous system. Due to the strong correlations with pain relief, the changes in EEG signals during cold-pressor test have the potential to serve as biomarkers of opioid analgesia. PERSPECTIVE: This exploratory study presents evidence of opioid specific effects on the pain system at peripheral and central levels. The findings give insights into which measures are the most sensitive for assessing opioid-specific effects.",2021,The decreases in EEG activity were correlated to subjective unpleasantness scores.,['Twenty healthy male volunteers'],"['morphine\u202f+\u202fnaloxone or placebo infusion', 'placebo', 'Opioid antagonist naloxone', 'morphine or placebo']","['subjective pain relief', 'Brain activity underlying slow cold-pressor EEG (1-4Hz', 'subjective unpleasantness scores', 'EEG activity', 'Longer lasting pain', 'central processing of sensation and pain', 'central processing of external stimuli', 'Quantitative sensory testing (QST), spinal nociceptive withdrawal reflexes (NWR), spinal electroencephalography (EEG), cortical EEG responses to external stimuli and resting EEG', 'structure pain (bone pressure) and strong nociceptive (NWR) stimulations']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0277847', 'cui_str': 'Flexion spinal defense reflex'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",20.0,0.0474266,The decreases in EEG activity were correlated to subjective unpleasantness scores.,"[{'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Lelic', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark. Electronic address: dl@mech-sense.com.'}, {'ForeName': 'Anne Estrup', 'Initials': 'AE', 'LastName': 'Olesen', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Grønlund', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Fabricio Ariel', 'Initials': 'FA', 'LastName': 'Jure', 'Affiliation': 'Integrative Neuroscience, Center for Sensory-Motor Interaction, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Asbjørn Mohr', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}]",The journal of pain,['10.1016/j.jpain.2021.06.011']
782,34232493,Efficacy of Nebulized Glycopyrrolate on Lung Hyperinflation in Patients with COPD.,"INTRODUCTION


Lung hyperinflation in chronic obstructive pulmonary disease (COPD) is associated with activity limitation, impaired cardiac output, and mortality. Several studies have demonstrated that long-acting muscarinic antagonists (LAMAs) delivered by dry powder inhalers can promote lung deflation; however, the potential of nebulized LAMAs on improving hyperinflation in COPD is currently unknown.
METHODS


This single-center, randomized, double-blind, two-way crossover study (NCT04155047) evaluated the efficacy of a single dose of nebulized LAMA [glycopyrrolate (GLY) 25 µg] versus placebo in patients with COPD and lung hyperinflation. Patients with moderate-to-severe COPD and a residual volume (RV) ≥ 130% of predicted normal were included. The primary endpoint was changed from baseline in RV at 6 h post-treatment. Other endpoints included changes from baseline in spirometric and plethysmographic measures up to 6 h post-treatment.
RESULTS


A total of 22 patients (mean pre-bronchodilator RV, 153.7% of predicted normal) were included. The primary objective of the study was not met; the placebo-adjusted least squares (LS) mean [95% confidence interval (CI) change from baseline in RV with GLY at 6 h post-treatment was - 0.323 l (- 0.711 to 0.066); p = 0.0987]. A post hoc evaluation of the primary analysis was conducted after excluding a single statistical outlier; substantial improvements in RV with GLY compared with placebo was observed after exclusion of this outlier [placebo-adjusted LS mean change from baseline (95% CI) in RV was - 0.446 l (- 0.741 to - 0.150)]. Improvements from baseline were also observed with GLY compared with placebo in spirometric and plethysmographic measures up to 6 h post-treatment. GLY was generally safe, and no new safety signals were detected.
CONCLUSIONS


This is the first study to evaluate the effect of nebulized GLY on lung deflation. Nebulized GLY resulted in marked improvements in RV up to 6 h post-treatment, compared with placebo. Improvements were also observed with GLY in spirometric and plethysmographic parameters of lung function.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT04155047.",2021,Improvements from baseline were also observed with GLY compared with placebo in spirometric and plethysmographic measures up to 6 h post-treatment.,"['Patients with COPD', 'chronic obstructive pulmonary disease (COPD', 'Patients with moderate-to-severe COPD and a residual volume (RV)\u2009≥\u2009130% of predicted normal were included', 'patients with COPD and lung hyperinflation', '22 patients']","['Nebulized Glycopyrrolate', 'nebulized LAMA [glycopyrrolate (GLY', 'nebulized GLY', 'placebo', 'Nebulized GLY']","['lung deflation', 'spirometric and plethysmographic measures', 'spirometric and plethysmographic parameters of lung function', 'Lung Hyperinflation', 'RV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}]",22.0,0.81235,Improvements from baseline were also observed with GLY compared with placebo in spirometric and plethysmographic measures up to 6 h post-treatment.,"[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Siler', 'Affiliation': 'Midwest Chest Consultants, St Charles, MO, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hohenwarter', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Kuangnan', 'Initials': 'K', 'LastName': 'Xiong', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Sciarappa', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Sanjar', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA. sanjay.sharma@sunovion.com.'}]",Pulmonary therapy,['10.1007/s41030-021-00166-5']
783,34234368,"""In my age, we didn't have the computers"": Using a complexity lens to understand uptake of diabetes eHealth innovations into primary care-A qualitative study.","BACKGROUND


Shared decision-making is a central component of person-centred care and can be facilitated with the use of patient decision aids (PtDA). Barriers and facilitators to shared decision-making and PtDA use have been identified, yet integration of PtDAs into clinical care is limited. We sought to understand why, using the concepts of complexity science.
METHODS


We conducted 60-minute in-depth interviews with patients with diabetes, primary care physicians, nurses and dietitians who had participated in a randomized controlled trial examining the impact of MyDiabetesPlan (an online goal-setting PtDA). Relying on a qualitative description approach, we used a semi-structured interview guide to explore participants' experiences with using MyDiabetesPlan and how it was integrated into the clinical encounter and clinical care. Audiotapes were transcribed verbatim, then coded independently by two analysts.
FINDINGS


17 interviews were conducted (5 physicians, 3 nurses, 2 dietitians, 7 patients). Two themes were developed: (1) MyDiabetesPlan appeared to empower patients by providing tailored patient-important information which engaged them in decision-making and self-care. Patients' use of MyDiabetesPlan was however impacted by their competing medical conditions, other life priorities and socioeconomic context. (2) MyDiabetesPlan emphasized to clinicians a patient-centred approach that helped patients assume greater ownership for their care. Clinicians' use of MyDiabetesPlan was impacted by pre-existing clinical tools/workplans, workflow, technical issues, clinic administrative logistics and support, and time. How clinicians adapted to these barriers influenced the degree to which MyDiabetesPlan was integrated into care.
CONCLUSIONS


A complexity lens (that considers relationships between multiple components of a complex system) may yield additional insights to optimize integration of PtDA into clinical care. A complexity lens recognizes that shared decision-making does not occur in the vacuum of a clinical dyad (patient and clinician), and will enable us to develop a family of interventions that address the whole process, rather than individual components.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02379078.",2021,"Patients' use of MyDiabetesPlan was however impacted by their competing medical conditions, other life priorities and socioeconomic context.","['patients with diabetes, primary care physicians, nurses and dietitians who had participated', '17 interviews were conducted (5 physicians, 3 nurses, 2 dietitians, 7 patients']",['MyDiabetesPlan'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",[],[],17.0,0.0803603,"Patients' use of MyDiabetesPlan was however impacted by their competing medical conditions, other life priorities and socioeconomic context.","[{'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Yu', 'Affiliation': ""Division of Endocrinology & Metabolism, Department of Medicine, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'McCann', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Sale', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}]",PloS one,['10.1371/journal.pone.0254157']
784,34234361,Assessment of the preventive effects of Nd:YAG laser associated with fluoride on enamel caries using optical coherence tomography and FTIR spectroscopy.,"OBJECTIVE


This in vitro study characterized and monitored, by Optical Coherence Tomography (OCT) and Fourier Transformed Infrared Spectroscopy (FTIR), the effects of the association of acidulated phosphate fluoride gel (APF-gel) and Nd:YAG (neodymiun:yttrium-aluminum-garnet) laser, as sequencial treatments, in the prevention of incipient enamel caries lesions.
METHODS


120 human enamel samples were randomized into 3 groups (n = 40): APF-gel (1.23% F-, 4 min.); Laser+APF (Nd:YAG laser irradiation-0.6W, 84.9J/cm2, 10Hz, followed by APF-gel); and APF+Laser (APF-gel followed by laser irradiation). The samples were subjected to a 15-day pH-cycling, evaluated by OCT (quantification of optical attenuation coefficient-OAC) and FTIR (analysis of carbonate and phosphate content) before treatments, after treatments, and on the 5th, 10th and 15th days of pH-cycling. The statistical analysis was performed (α = 5%).
RESULTS


The Optical Attenuation Coefficient (OAC) assessed by OCT increases with the progression of demineralization, and the Laser+APF presented the highest values of OAC in 10th and 15th days of pH-cycling. Nd:YAG decreased the carbonate content after treatment regardless of the application order of the APF-gel, while APF-gel did not interfere in the composition of enamel. The carbonate content was also changed in the first 5 days of the pH-cycling in all groups.
CONCLUSION


Nd:YAG laser irradiation before or after the application of APF-gel did not influence the appearance of incipient caries lesions, showing no synergistic effect. Regardless of the application order of the APF-gel, laser irradiation reduces the carbonate content of the enamel, which also changes during the demineralization process. However, irradiation before the application of APF-gel increased the speed of progression of the lesions, which positively impacts public health as it can prevent caries disease, even in high risk individuals. OCT and FTIR are suitable for assessing this effect.",2021,"Regardless of the application order of the APF-gel, laser irradiation reduces the carbonate content of the enamel, which also changes during the demineralization process.",['120 human enamel samples were randomized into 3 groups (n = 40'],"['YAG (neodymiun:yttrium-aluminum-garnet) laser', 'APF-gel', 'APF-gel, laser irradiation', 'Optical Coherence Tomography (OCT) and Fourier Transformed Infrared Spectroscopy (FTIR', 'Nd:YAG laser', 'Laser+APF (Nd:YAG laser irradiation-0.6W, 84.9J/cm2, 10Hz, followed by APF-gel); and APF+Laser (APF-gel followed by laser irradiation', 'fluoride', 'acidulated phosphate fluoride gel (APF-gel) and Nd']","['Optical Attenuation Coefficient (OAC', 'composition of enamel']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C3881208', 'cui_str': 'Fluoride gel'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0282183', 'cui_str': 'Fourier Transform'}, {'cui': 'C0260249', 'cui_str': 'Infrared spectroscopy'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}]","[{'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}]",120.0,0.0166221,"Regardless of the application order of the APF-gel, laser irradiation reduces the carbonate content of the enamel, which also changes during the demineralization process.","[{'ForeName': 'Marcia Cristina', 'Initials': 'MC', 'LastName': 'Dias-Moraes', 'Affiliation': 'Center for Lasers and Applications, Instituto de Pesquisas Energeticas e Nucleares, IPEN-CNEN/SP, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Pedro Arthur Augusto', 'Initials': 'PAA', 'LastName': 'Castro', 'Affiliation': 'Center for Lasers and Applications, Instituto de Pesquisas Energeticas e Nucleares, IPEN-CNEN/SP, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Daísa Lima', 'Initials': 'DL', 'LastName': 'Pereira', 'Affiliation': 'Center for Lasers and Applications, Instituto de Pesquisas Energeticas e Nucleares, IPEN-CNEN/SP, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Patrícia Aparecida', 'Initials': 'PA', 'LastName': 'Ana', 'Affiliation': 'Center for Engineering, Modelling and Applied Social Sciences, Universidade Federal do ABC, Sao Bernardo do Campo, SP, Brazil.'}, {'ForeName': 'Anderson Zanardi', 'Initials': 'AZ', 'LastName': 'Freitas', 'Affiliation': 'Center for Lasers and Applications, Instituto de Pesquisas Energeticas e Nucleares, IPEN-CNEN/SP, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Denise Maria', 'Initials': 'DM', 'LastName': 'Zezell', 'Affiliation': 'Center for Lasers and Applications, Instituto de Pesquisas Energeticas e Nucleares, IPEN-CNEN/SP, Sao Paulo, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0254217']
785,34238546,Proteomic signatures for perioperative oxygen delivery in skin after major elective surgery: mechanistic sub-study of a randomised controlled trial.,"BACKGROUND


Maintaining adequate oxygen delivery (DO 2 ) after major surgery is associated with minimising organ dysfunction. Skin is particularly vulnerable to reduced DO 2 . We tested the hypothesis that reduced perioperative DO 2  fuels inflammation in metabolically compromised skin after major surgery.
METHODS


Participants undergoing elective oesophagectomy were randomised immediately after surgery to standard of care or haemodynamic therapy to achieve their individualised preoperative DO 2 . Abdominal punch skin biopsies were snap-frozen before and 48 h after surgery. On-line two-dimensional liquid chromatography and ultra-high-definition label-free mass spectrometry was used to characterise the skin proteome. The primary outcome was proteomic changes compared between normal (≥preoperative value before induction of anaesthesia) and low DO 2  (<preoperative value before induction of anaesthesia) after surgery. Secondary outcomes were functional enrichment analysis of up/down-regulated proteins (Ingenuity pathway analysis; STRING Protein-Protein Interaction Networks). Immunohistochemistry and immunoblotting confirmed selected proteomic findings in skin biopsies obtained from patients after hepatic resection.
RESULTS


Paired punch skin biopsies were obtained from 35 participants (mean age: 68 yr; 31% female), of whom 17 underwent oesophagectomy. There were 14/2096 proteins associated with normal (n=10) vs low (n=7) DO 2  after oesophagectomy. Failure to maintain preoperative DO 2  was associated with upregulation of proteins counteracting oxidative stress. Normal DO 2  after surgery was associated with pathways involving leucocyte recruitment and upregulation of an antimicrobial peptidoglycan recognition protein. Immunohistochemistry (n=6 patients) and immunoblots after liver resection (n=12 patients) supported the proteomic findings.
CONCLUSIONS


Proteomic profiles in serial skin biopsies identified organ-protective mechanisms associated with normal DO 2  after major surgery.
CLINICAL TRIAL REGISTRATION


ISRCTN76894700.",2021,"METHODS


Participants undergoing elective oesophagectomy were randomised immediately after surgery to standard of care or haemodynamic therapy to achieve their individualised preoperative DO 2 .","['skin after major elective surgery', 'Participants undergoing elective oesophagectomy', '35 participants (mean age: 68 yr; 31% female), of whom 17 underwent oesophagectomy', 'n=6 patients) and immunoblots after liver resection (n=12 patients) supported the proteomic findings']","['surgery to standard of care or haemodynamic therapy', 'Immunohistochemistry']","['proteomic changes compared between normal (≥preoperative value before induction of anaesthesia) and low DO 2  (<preoperative value before induction of anaesthesia', 'functional enrichment analysis of up/down-regulated proteins (Ingenuity pathway analysis; STRING Protein-Protein Interaction Networks']","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020985', 'cui_str': 'Immunoblotting'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0872252', 'cui_str': 'Proteomics'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}]","[{'cui': 'C0872252', 'cui_str': 'Proteomics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0443313', 'cui_str': 'Stringing'}, {'cui': 'C3178902', 'cui_str': 'Protein Interaction Networks'}]",,0.215221,"METHODS


Participants undergoing elective oesophagectomy were randomised immediately after surgery to standard of care or haemodynamic therapy to achieve their individualised preoperative DO 2 .","[{'ForeName': 'Wendy E', 'Initials': 'WE', 'LastName': 'Heywood', 'Affiliation': 'Translational Mass Spectrometry Research Group, UCL Institute of Child Health, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bliss', 'Affiliation': 'Translational Mass Spectrometry Research Group, UCL Institute of Child Health, London, UK.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Bahelil', 'Affiliation': 'Translational Medicine & Therapeutics, William Harvey Research Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Trinda', 'Initials': 'T', 'LastName': 'Cyrus', 'Affiliation': 'Translational Medicine & Therapeutics, William Harvey Research Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Crescente', 'Affiliation': 'Department of Life Sciences, Manchester Metropolitan University Manchester, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Translational Medicine & Therapeutics, William Harvey Research Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Iqbal', 'Affiliation': 'University College London NHS Hospitals Trust, London, UK.'}, {'ForeName': 'Laura G', 'Initials': 'LG', 'LastName': 'Paredes', 'Affiliation': 'University College London NHS Hospitals Trust, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Toner', 'Affiliation': 'Department of Anesthesia, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Ana G', 'Initials': 'AG', 'LastName': 'Del Arroyo', 'Affiliation': 'Translational Medicine & Therapeutics, William Harvey Research Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Edel A', 'Initials': 'EA', 'LastName': ""O'Toole"", 'Affiliation': 'Centre for Cell Biology and Cutaneous Research, Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'Translational Mass Spectrometry Research Group, UCL Institute of Child Health, London, UK.'}, {'ForeName': 'Gareth L', 'Initials': 'GL', 'LastName': 'Ackland', 'Affiliation': 'Translational Medicine & Therapeutics, William Harvey Research Institute, Queen Mary University of London, London, UK. Electronic address: g.ackland@qmul.ac.uk.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.06.003']
786,34186022,"Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial.","BACKGROUND


Despite advancements in care, many people with type 2 diabetes do not meet treatment goals; thus, development of new therapies is needed. We aimed to assess efficacy, safety, and tolerability of novel dual glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist tirzepatide monotherapy versus placebo in people with type 2 diabetes inadequately controlled by diet and exercise alone.
METHODS


We did a 40-week, double-blind, randomised, placebo-controlled, phase 3 trial (SURPASS-1), at 52 medical research centres and hospitals in India, Japan, Mexico, and the USA. Adult participants (≥18 years) were included if they had type 2 diabetes inadequately controlled by diet and exercise alone and if they were naive to injectable diabetes therapy. Participants were randomly assigned (1:1:1:1) via computer-generated random sequence to once a week tirzepatide (5, 10, or 15 mg), or placebo. All participants, investigators, and the sponsor were masked to treatment assignment. The primary endpoint was the mean change in glycated haemoglobin (HbA 1c ) from baseline at 40 weeks. This study is registered with ClinicalTrials.gov, NCT03954834.
FINDINGS


From June 3, 2019, to Oct 28, 2020, of 705 individuals assessed for eligibility, 478 (mean baseline HbA 1c  7·9% [63 mmol/mol], age 54·1 years [SD 11·9], 231 [48%] women, diabetes duration 4·7 years, and body-mass index 31·9 kg/m 2 ) were randomly assigned to tirzepatide 5 mg (n=121 [25%]), tirzepatide 10 mg (n=121 [25%]), tirzepatide 15 mg (n=121 [25%]), or placebo (n=115 [24%]). 66 (14%) participants discontinued the study drug and 50 (10%) discontinued the study prematurely. At 40 weeks, all tirzepatide doses were superior to placebo for changes from baseline in HbA 1c , fasting serum glucose, bodyweight, and HbA 1c  targets of less than 7·0% (<53 mmol/mol) and less than 5·7% (<39 mmol/mol). Mean HbA 1c  decreased from baseline by 1·87% (20 mmol/mol) with tirzepatide 5 mg, 1·89% (21 mmol/mol) with tirzepatide 10 mg, and 2·07% (23 mmol/mol) with tirzepatide 15 mg versus +0·04% with placebo (+0·4 mmol/mol), resulting in estimated treatment differences versus placebo of -1·91% (-21 mmol/mol) with tirzepatide 5 mg, -1·93% (-21 mmol/mol) with tirzepatide 10 mg, and -2·11% (-23 mmol/mol) with tirzepatide 15 mg (all p<0·0001). More participants on tirzepatide than on placebo met HbA 1c  targets of less than 7·0% (<53 mmol/mol; 87-92% vs 20%) and 6·5% or less (≤48 mmol/mol; 81-86% vs 10%) and 31-52% of patients on tirzepatide versus 1% on placebo reached an HbA 1c  of less than 5·7% (<39 mmol/mol). Tirzepatide induced a dose-dependent bodyweight loss ranging from 7·0 to 9·5 kg. The most frequent adverse events with tirzepatide were mild to moderate and transient gastrointestinal events, including nausea (12-18% vs 6%), diarrhoea (12-14% vs 8%), and vomiting (2-6% vs 2%). No clinically significant (<54 mg/dL [<3 mmol/L]) or severe hypoglycaemia were reported with tirzepatide. One death occurred in the placebo group.
INTERPRETATION


Tirzepatide showed robust improvements in glycaemic control and bodyweight, without increased risk of hypoglycaemia. The safety profile was consistent with GLP-1 receptor agonists, indicating a potential monotherapy use of tirzepatide for type 2 diabetes treatment.
FUNDING


Eli Lilly and Company.",2021,"At 40 weeks, all tirzepatide doses were superior to placebo for changes from baseline in HbA 1c , fasting serum glucose, bodyweight, and HbA 1c  targets of less than 7·0% (<53 mmol/mol) and less than 5·7% (<39 mmol/mol).","['From June 3, 2019, to Oct 28, 2020, of 705 individuals assessed for eligibility, 478 (mean baseline HbA 1c  7·9% [63 mmol/mol], age 54·1 years [SD 11·9], 231 [48%] women, diabetes duration 4·7 years, and body-mass index 31·9 kg/m 2 ', 'patients with type 2 diabetes (SURPASS-1', 'Adult participants (≥18 years) were included if they had type 2 diabetes inadequately controlled by', '52 medical research centres and hospitals in India, Japan, Mexico, and the USA', 'people with type 2 diabetes inadequately controlled by diet and exercise alone', '66 (14%) participants discontinued the study drug and 50 (10%) discontinued the study prematurely']","['tirzepatide 5 mg, -1·93% (-21 mmol/mol) with tirzepatide 10 mg, and -2·11% (-23 mmol/mol) with tirzepatide', 'Tirzepatide', 'novel dual GIP and GLP-1 receptor agonist tirzepatide', 'dL', 'tirzepatide', 'diet and exercise alone and if they were naive to injectable diabetes therapy', 'novel dual glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist tirzepatide monotherapy versus placebo', 'computer-generated random sequence to once a week tirzepatide', 'placebo']","['mean change in glycated haemoglobin (HbA 1c ', 'Mean HbA 1c', 'risk of hypoglycaemia', 'Efficacy and safety', 'diarrhoea', 'One death', 'severe hypoglycaemia', 'vomiting', 'glycaemic control and bodyweight', 'nausea', 'HbA 1c , fasting serum glucose, bodyweight, and HbA 1c  targets', 'efficacy, safety, and tolerability']","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}]",,0.372236,"At 40 weeks, all tirzepatide doses were superior to placebo for changes from baseline in HbA 1c , fasting serum glucose, bodyweight, and HbA 1c  targets of less than 7·0% (<53 mmol/mol) and less than 5·7% (<39 mmol/mol).","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX, USA. Electronic address: juliorosenstock@dallasdiabetes.com.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Wysham', 'Affiliation': 'MultiCare Rockwood Clinic, Spokane, WA, USA.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frías', 'Affiliation': 'National Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Takatsuki Red Cross Hospital, Osaka, Japan.'}, {'ForeName': 'Clare J', 'Initials': 'CJ', 'LastName': 'Lee', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fernández Landó', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Huzhang', 'Initials': 'H', 'LastName': 'Mao', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Chrisanthi A', 'Initials': 'CA', 'LastName': 'Karanikas', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Vivian T', 'Initials': 'VT', 'LastName': 'Thieu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(21)01324-6']
787,34196886,Changes in biomarkers after 180 days of tobacco heating product use: a randomised trial.,"The aim of this study was to investigate whether biomarkers of exposure (BoE) and potential harm (BoPH) are modified when smokers switch from smoking cigarettes to exclusive use of a tobacco heating product (THP) in an ambulatory setting. Participants in this randomised, controlled study were healthy volunteer smokers assigned either to continue smoking or switch to a THP, and a control group of smokers who abstained from cigarette smoking. Various BoE and BoPH related to oxidative stress, cardiovascular and respiratory diseases, and cancer were assessed at baseline and up to 180 days. In continuing smokers, BoE and BoPH remained stable between baseline and day 180, while THP users' levels of most BoE reduced significantly, becoming similar to those in controls abstaining from cigarette smoking. Also at 180 days, significant changes in numerous BoPH, including total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, 8-epi-prostaglandin F2α type III, fractional concentration of exhaled nitric oxide and white blood cell count, were directionally consistent with lessened health impact. Our findings support the notion that the deleterious health impacts of cigarette smoking may be reduced in smokers who completely switch to using THPs.",2021,"Also at 180 days, significant changes in numerous BoPH, including total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, 8-epi-prostaglandin F2α type III, fractional concentration of exhaled nitric oxide and white blood cell count, were directionally consistent with lessened health impact.",['healthy volunteer smokers assigned either to'],"['continue smoking or switch to a THP, and a control group of smokers who abstained from cigarette smoking', 'exposure (BoE) and potential harm (BoPH', 'tobacco heating product (THP']","['oxidative stress, cardiovascular and respiratory diseases, and cancer', 'numerous BoPH, including total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, 8-epi-prostaglandin F2α type III, fractional concentration of exhaled nitric oxide and white blood cell count']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butan-1-ol'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",,0.134994,"Also at 180 days, significant changes in numerous BoPH, including total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, 8-epi-prostaglandin F2α type III, fractional concentration of exhaled nitric oxide and white blood cell count, were directionally consistent with lessened health impact.","[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Gale', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Regents Park Road, Southampton, SO15 8TL, UK. nathan_gale@bat.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McEwan', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Regents Park Road, Southampton, SO15 8TL, UK.'}, {'ForeName': 'Oscar M', 'Initials': 'OM', 'LastName': 'Camacho', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Regents Park Road, Southampton, SO15 8TL, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hardie', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Regents Park Road, Southampton, SO15 8TL, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Proctor', 'Affiliation': 'DoctorProctorScience Limited, 157 Cavendish Meads, Sunninghill, Ascot, SL5 9TG, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'R. J. Reynolds Tobacco Company, 401 N Main Street, Winston-Salem, NC27101, USA.'}]",Internal and emergency medicine,['10.1007/s11739-021-02798-6']
788,34198230,The temporal sequence of change in PTSD symptoms and hypothesized mediators in Cognitive Processing Therapy and Written Exposure Therapy for PTSD.,"We examined whether extinction or changes negative trauma-related beliefs occur either prior to or concurrently with changes in posttraumatic stress symptoms among individuals who received either Cognitive Processing Therapy (CPT) or Written Exposure Therapy (WET) using statistical methods that permit proper discernment of temporal sequence. Community participants with PTSD (N = 126) were evenly randomized to 12 sessions of CPT or 5 sessions of WET. We assessed within- and between-session changes in arousal and valence and changes in trauma-related beliefs 6-, 12-, 24-, 36- and 60-weeks following the first treatment session. Between-session change in post-session emotional valence temporally preceded PTSD symptom reduction among participants who received WET but did not predict subsequent symptom reduction. Although negative trauma-related beliefs changed in parallel with and correlated with PTSD symptom reduction in both conditions, this change did not temporally precede symptom reduction. Our results are inconsistent with those from prior studies and suggest these constructs may more appropriately be characterized as correlates, rather than mediators, of symptom reduction. These results highlight the value of discernment of the temporal sequence of change between hypothesized mediators and symptoms and underscore that we still have much to learn about how evidence-based treatments reduce PTSD symptoms.",2021,Between-session change in post-session emotional valence temporally preceded PTSD symptom reduction among participants who received WET but did not predict subsequent symptom reduction.,"['Community participants with PTSD (N\xa0=\xa0126', 'individuals who received either']","['CPT or 5 sessions of WET', 'Cognitive Processing Therapy (CPT) or Written Exposure Therapy (WET']","['PTSD symptom reduction', 'arousal and valence and changes in trauma-related beliefs']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",126.0,0.078475,Between-session change in post-session emotional valence temporally preceded PTSD symptom reduction among participants who received WET but did not predict subsequent symptom reduction.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'National Center for PTSD, Boston, MA, USA; VA Boston Healthcare System, Boston, MA, USA; Boston University School of Medicine, Boston, MA, USA. Electronic address: Daniel.Lee14@va.gov.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Marx', 'Affiliation': 'National Center for PTSD, Boston, MA, USA; VA Boston Healthcare System, Boston, MA, USA; Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Thompson-Hollands', 'Affiliation': 'National Center for PTSD, Boston, MA, USA; VA Boston Healthcare System, Boston, MA, USA; Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': 'Duke Health, Durham, NC, USA.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Sloan', 'Affiliation': 'National Center for PTSD, Boston, MA, USA; VA Boston Healthcare System, Boston, MA, USA; Boston University School of Medicine, Boston, MA, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103918']
789,34217789,The Impact of Radiation Therapy in Children and Adolescents With Metastatic Rhabdomyosarcoma.,"PURPOSE


There is limited evidence to define the role of radiation therapy in children with metastatic rhabdomyosarcoma (mRMS). In the international BERNIE study, children with mRMS or non-RMS soft tissue sarcoma were randomized to receive standard chemotherapy with or without bevacizumab, with radiation therapy to all disease sites recommended after chemotherapy cycle 6. We retrospectively evaluated the impact of radiation therapy on survival in the mRMS cohort.
METHODS AND MATERIALS


Patients were grouped according to the radiation therapy they received: radical, partial, or none. Radical irradiation was defined as radiation therapy delivered to all disease sites, unless a site was completely surgically resected. Partial irradiation was defined as radiation therapy to ≥1, but not all, disease sites. Landmark analysis excluded patients with an event before day 221. Overall survival (OS) and event-free survival (EFS) were modeled using Cox proportional hazards models.
RESULTS


Of 102 patients with mRMS, 97 were included in the analysis for OS and 85 for EFS. Overall, 27 patients received radical irradiation, 46 partial irradiation, and 24 no irradiation. EFS was not significantly different among patient groups after adjustment for prognostic factors (hazard ratio [HR] = 0.520; P = .054 for any vs no irradiation). Radiation therapy was associated with improved OS compared with no radiation therapy (adjusted HR = 0.249; P = .00025), with OS being greater for radical versus partial irradiation (HR = 0.245; P = .039). The 3-year OS rate was 84%, 54%, and 23% for patients receiving radical, partial, and no irradiation, respectively. Radical treatment (surgery, irradiation, or both) of the primary site improved EFS and OS compared with no treatment.
CONCLUSIONS


These findings demonstrate variability in the application of radiation therapy for mRMS and support the routine use of radical treatment to the primary site. Radical irradiation to metastatic sites may further improve OS. The burden of such treatment should be balanced against prognosis; further studies are needed.",2021,"Radiotherapy was associated with improved OS compared with no radiotherapy (adjusted HR = 0.249; P = 0.00025), with OS greater for radical versus partial irradiation (HR = 0.245; P = 0.039).","['Children and Adolescents with Metastatic Rhabdomyosarcoma', 'children with metastatic rhabdomyosarcoma (mRMS', 'patients with an event prior to Day 221', '102 patients with mRMS', 'Patients were grouped according to the radiotherapy they received: radical, partial or none', 'children with mRMS or non-RMS soft tissue sarcoma']","['radiotherapy', 'Radiotherapy', 'radical irradiation, 46 partial irradiation and 24 no irradiation', 'Radical irradiation', 'standard chemotherapy with/without bevacizumab, with radiotherapy']","['EFS and OS', 'survival', 'EFS', 'Overall survival (OS) and event-free survival (EFS', '3-year OS rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0456148', 'cui_str': 'Null'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",102.0,0.129812,"Radiotherapy was associated with improved OS compared with no radiotherapy (adjusted HR = 0.249; P = 0.00025), with OS greater for radical versus partial irradiation (HR = 0.245; P = 0.039).","[{'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Cameron', 'Affiliation': 'Bristol Haematology and Oncology Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom. Electronic address: Alison.Cameron@UHBW.nhs.uk.'}, {'ForeName': 'Markus C', 'Initials': 'MC', 'LastName': 'Elze', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Casanova', 'Affiliation': 'Pediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Geoerger', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave Roussy Cancer Center, University Paris-Saclay, INSERM U1015, Villejuif, France.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Gaze', 'Affiliation': 'Department of Oncology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave Roussy Cancer Center, University Paris-Saclay, INSERM U1015, Villejuif, France.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'McHugh', 'Affiliation': 'Department of Radiology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Rick R', 'Initials': 'RR', 'LastName': 'van Rijn', 'Affiliation': ""Department of Radiology and Nuclear Medicine, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, the Netherlands.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kelsey', 'Affiliation': ""Department of Paediatric Histopathology, Manchester University NHS Foundation Trust, Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Martelli', 'Affiliation': 'Department of Paediatric Surgery, Hôpital Bicêtre-Hôpitaux Universitaires Paris-Saclay, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Mandeville', 'Affiliation': 'Department of Radiotherapy, the Royal Marsden NHS Foundation Trust, and the Institute of Cancer Research, Sutton, United Kingdom.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Bisogno', 'Affiliation': ""Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lowis', 'Affiliation': 'Department of Paediatric and Adolescent Oncology, Bristol Royal Hospital for Children, Bristol, United Kingdom.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Ronghe', 'Affiliation': 'Department of Paediatric Oncology, Royal Hospital for Children, Glasgow, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Orbach', 'Affiliation': 'SIREDO Oncology Center, Institut Curie, PSL University, Paris, France.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Guizani', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Fürst-Recktenwald', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Chisholm', 'Affiliation': ""Children and Young People's Unit, the Royal Marsden NHS Foundation Trust, and the Institute of Cancer Research, Sutton, United Kingdom.""}, {'ForeName': 'Johannes H M', 'Initials': 'JHM', 'LastName': 'Merks', 'Affiliation': ""Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands; Department of Pediatric Oncology, Emma Children's Hospital-Academic Medical Center (EKZ-AMC), Amsterdam, the Netherlands.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.06.031']
790,34217600,Theta-burst versus 20 Hz repetitive transcranial magnetic stimulation in neuropathic pain: A head-to-head comparison.,"OBJECTIVE


High-frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to reduce neuropathic pain, but intermittent ""theta-burst"" stimulation (iTBS) could be a better alternative because of shorter duration and greater ability to induce cortical plasticity. Here we compared head-to-head the pain-relieving efficacy of the two modalities when applied daily for 5 days to patients with neuropathic pain.
METHODS


Forty-six patients received 20 Hz-rTMS and/or iTBS protocols and 39 of them underwent the full two procedures in a random cross-over design. They rated pain intensity, sleep quality, fatigue and general health status daily during 5 consecutive weeks.
RESULTS


Pain relief during the month following stimulation was superior after 20 Hz-rTMS relative to iTBS (F(1,38) = 4.645; p = 0.037). Correlation between respective levels of maximal relief showed a significant deviation toward the 20 Hz-rTMS effect. A greater proportion of individuals responded to 20 Hz-rTMS (52% vs 32%, 95 %CI[0.095-3.27]; p = 0.06), and reports of fatigue significantly improved after 20 Hz-rTMS relative to iTBS (p = 0.01). General health and sleep quality scores did not differentiate both techniques.
CONCLUSIONS


High-frequency rTMS appeared superior to iTBS for neuropathic pain relief.
SIGNIFICANCE


Adequate matching between the oscillatory activity of motor cortex and that of rTMS may increase synaptic efficacy, thus enhancing functional connectivity of motor cortex with distant structures involved in pain regulation.",2021,"A greater proportion of individuals responded to 20 Hz-rTMS (52% vs 32%, 95 %CI[0.095-3.27]; p = 0.06), and reports of fatigue significantly improved after 20 Hz-rTMS relative to iTBS (p = 0.01).","['Forty-six patients received', 'patients with neuropathic pain', 'neuropathic pain']","['rTMS', 'High-frequency repetitive transcranial magnetic stimulation (rTMS', 'Theta-burst versus 20\xa0Hz repetitive transcranial magnetic stimulation', '20\xa0Hz-rTMS and/or iTBS protocols']","['General health and sleep quality scores', 'synaptic efficacy', 'rated pain intensity, sleep quality, fatigue and general health status daily', 'Pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",,0.0112448,"A greater proportion of individuals responded to 20 Hz-rTMS (52% vs 32%, 95 %CI[0.095-3.27]; p = 0.06), and reports of fatigue significantly improved after 20 Hz-rTMS relative to iTBS (p = 0.01).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'André-Obadia', 'Affiliation': 'Neurophysiology & Epilepsy Unit, Neurological Hospital P. Wertheimer, Hospices Civils de Lyon, France; University Hospital Pain Center (CETD), Neurological Hospital P. Wertheimer, Hospices Civils de Lyon, France; NeuroPain Lab, INSERM U1028, CNRS UMR5292, Lyon Neuroscience Research Center, University Claude Bernard Lyon 1, France. Electronic address: nathalie.obadia-andre@chu-lyon.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Magnin', 'Affiliation': 'NeuroPain Lab, INSERM U1028, CNRS UMR5292, Lyon Neuroscience Research Center, University Claude Bernard Lyon 1, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Garcia-Larrea', 'Affiliation': 'University Hospital Pain Center (CETD), Neurological Hospital P. Wertheimer, Hospices Civils de Lyon, France; NeuroPain Lab, INSERM U1028, CNRS UMR5292, Lyon Neuroscience Research Center, University Claude Bernard Lyon 1, France.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2021.05.022']
791,34225252,Effect of Previous-Day Alcohol Ingestion on Muscle Function and Performance of Severe-Intensity Exercise.,"PURPOSE


Many athletes report consuming alcohol the day before their event, which might negatively affect their performance. However, the effects of previous-day alcohol ingestion on performance are equivocal, in part, due to no standardization of alcohol dose in previous studies. The purpose of this study was to examine the impact of a standardized previous-day alcohol dose and its corresponding impact on morning-after muscular strength, muscular power, and muscular fatigue in a short-duration test and on performance of severe-intensity exercise.
METHODS


On 2 occasions, 12 recreationally active individuals reported to the Applied Physiology Laboratory in the evening and ingested a beverage containing either 1.09 g ethanol·kg-1 fat-free body mass (ALC condition) or water (PLA condition). The following morning, they completed a hangover symptom questionnaire, vertical jumps, isometric midthigh pulls, biceps curls, and a constant-power cycle ergometer test to exhaustion. The responses from ALC and PLA were compared using paired-means t tests.
RESULTS


Time to exhaustion in the cycle ergometer tests was less (P = .03) in the ALC condition (181 [39] s vs 203 [34] s; -11%, Cohen d = 0.61). There was no difference in performance in vertical jump test, isometric midthigh pulls, and biceps curls tests between the ALC and PLA conditions.
CONCLUSIONS


Previous-day alcohol consumption significantly reduces morning-after performance of severe-intensity exercise. Practitioners should educate their athletes, especially those whose events rely on anaerobic capacity and/or a rapid response of the aerobic pathways, of the adverse effect of previous-day alcohol consumption on performance.",2021,"There was no difference in performance in vertical jump test, isometric midthigh pulls, and biceps curls tests between the ALC and PLA conditions.
",[],['Previous-Day Alcohol Ingestion'],"['performance in vertical jump test, isometric midthigh pulls, and biceps curls tests', 'hangover symptom questionnaire, vertical jumps, isometric midthigh pulls, biceps curls, and a constant-power cycle ergometer test to exhaustion', 'Muscle Function and Performance of Severe-Intensity Exercise', 'morning-after muscular strength, muscular power, and muscular fatigue']",[],"[{'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C4720934', 'cui_str': 'Vertical jump test'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221100', 'cui_str': 'Hangover'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0554816', 'cui_str': 'Morning after'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}]",,0.0219585,"There was no difference in performance in vertical jump test, isometric midthigh pulls, and biceps curls tests between the ALC and PLA conditions.
","[{'ForeName': 'Alex G', 'Initials': 'AG', 'LastName': 'Shaw', 'Affiliation': ''}, {'ForeName': 'Sungwon', 'Initials': 'S', 'LastName': 'Chae', 'Affiliation': ''}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Levitt', 'Affiliation': ''}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Nicholson', 'Affiliation': ''}, {'ForeName': 'Jakob L', 'Initials': 'JL', 'LastName': 'Vingren', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hill', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0790']
792,34228066,Effect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial.,"Importance


Cytisine is more effective than placebo and nicotine replacement therapy for smoking cessation. However, cytisine has not been tested against the most effective smoking cessation medication, varenicline, which is associated with adverse events known to lead to discontinuation of therapy.
Objective


To examine whether standard cytisine treatment (25 days) was at least as effective as standard varenicline treatment (84 days) for smoking cessation.
Design, Setting, and Participants


This noninferiority, open-label randomized clinical trial with allocation concealment and blinded outcome assessment was undertaken in Australia from November 2017 through May 2019; follow-up was completed in January 2020. A total of 1452 Australian adult daily smokers willing to make a quit attempt were included. Data collection was conducted primarily by computer-assisted telephone interview, but there was an in-person visit to validate the primary outcome.
Interventions


Treatments were provided in accordance with the manufacturers' recommended dosage: cytisine (n = 725), 1.5-mg capsules taken 6 times daily initially then gradually reduced over the 25-day course; varenicline (n = 727), 0.5-mg tablets titrated to 1 mg twice daily for 84 days (12 weeks). All participants were offered referral to standard telephone behavioral support.
Main Outcomes and Measures


The primary outcome was 6-month continuous abstinence verified using a carbon monoxide breath test at 7-month follow-up. The noninferiority margin was set at 5% and the 1-sided significance threshold was set at .025.
Results


Among 1452 participants who were randomized (mean [SD] age, 42.9 [12.7] years; 742 [51.1%] women), 1108 (76.3%) completed the trial. Verified 6-month continuous abstinence rates were 11.7% for the cytisine group and 13.3% for the varenicline group (risk difference, -1.62% [1-sided 97.5% CI, -5.02% to ∞]; P = .03 for noninferiority). Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95; P = .002).
Conclusions and Relevance


Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation.
Trial Registration


anzctr.org.au Identifier: ACTRN12616001654448.",2021,"Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95; P = .002).
","['1452 Australian adult daily smokers willing to make a quit attempt were included', 'Australia from November 2017 through May 2019; follow-up was completed in January 2020', 'Smoking Cessation', '1452 participants who were randomized (mean [SD] age, 42.9 [12.7] years; 742 [51.1%] women), 1108 (76.3%) completed the trial', 'All participants were offered referral to standard telephone behavioral support']","['anzctr.org.au Identifier', 'varenicline', 'Cytisine vs Varenicline', 'standard cytisine treatment', 'placebo']","['6-month continuous abstinence verified using a carbon monoxide breath test', 'Self-reported adverse events', 'incident rate ratio', 'Verified 6-month continuous abstinence rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517773', 'cui_str': '42.9'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0056913', 'cui_str': 'cytisine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",1452.0,0.301818,"Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95; P = .002).
","[{'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Courtney', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'McRobbie', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Tutka', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, University of Rzeszow, Rzeszow, Poland.'}, {'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Weaver', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Petrie', 'Affiliation': 'Centre for Health Economics, Monash Business School, Monash University, Clayton, Australia.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'Mendelsohn', 'Affiliation': 'No affiliation.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Shakeshaft', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Talukder', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Macdonald', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Priority Research Centre for Healthy Lungs, Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Benjamin C H', 'Initials': 'BCH', 'LastName': 'Kwan', 'Affiliation': 'St George and Sutherland Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Walker', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Gartner', 'Affiliation': 'School of Public Health, University of Queensland, Herston, Australia.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Mattick', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'Tasmanian School of Medicine, College of Health and Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Zwar', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Robina, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Richmond', 'Affiliation': 'School of Population Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Doran', 'Affiliation': 'Cluster for Resilience and Wellbeing, Appleton Institute, Central Queensland University, Brisbane, Australia.'}, {'ForeName': 'Veronica C', 'Initials': 'VC', 'LastName': 'Boland', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Hall', 'Affiliation': 'National Centre for Youth Substance Use Research, University of Queensland, Herston, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, England.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}]",JAMA,['10.1001/jama.2021.7621']
793,34232456,Exercise as a smoking cessation treatment for women: a randomized controlled trial.,"Cigarette smoking remains the leading behavioral risk factor for chronic disease and premature mortality. This RCT tested the efficacy of moderate intensity aerobic exercise as an adjunctive smoking cessation treatment among women. Participants (N = 105; age = 42.5, SD = 11.2) received brief smoking cessation counseling and 10 weeks of nicotine replacement therapy and were randomized to 12 weeks of moderate intensity exercise (Exercise; n = 53) or 12 weeks of health education (Control; n = 52). Longitudinal models, with Generalized Estimating Equations, showed no differences between Exercise and Control in cotinine-verified 7-day point prevalence abstinence (Wald = 1.96, p = 0.10) or continuous abstinence (Wald = 1.45, p = 0.23) at 12-weeks (post-treatment) or 6-, 9-, or 12-month follow-up, controlling for differences in baseline nicotine dependence. There was no effect of exercise on smoking cessation. The present study adds to the literature suggesting null effects of exercise as a smoking cessation adjunctive treatment despite promising findings in short-term laboratory based studies.",2021,"Longitudinal models, with Generalized Estimating Equations, showed no differences between Exercise and Control in cotinine-verified 7-day point prevalence abstinence (Wald = 1.96, p = 0.10) or continuous abstinence (Wald = 1.45, p = 0.23) at 12-weeks (post-treatment) or 6-, 9-, or 12-month follow-up, controlling for differences in baseline nicotine dependence.","['women', 'Participants (N\u2009=\u2009105; age\u2009=\u200942.5, SD\u2009=\u200911.2) received']","['moderate intensity exercise (Exercise; n\u2009=\u200953) or 12\xa0weeks of health education (Control; n\u2009=\u200952', 'brief smoking cessation counseling', 'nicotine replacement therapy', 'Exercise', 'moderate intensity aerobic exercise']","['Exercise and Control in cotinine-verified 7-day point prevalence abstinence', 'smoking cessation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0346835,"Longitudinal models, with Generalized Estimating Equations, showed no differences between Exercise and Control in cotinine-verified 7-day point prevalence abstinence (Wald = 1.96, p = 0.10) or continuous abstinence (Wald = 1.45, p = 0.23) at 12-weeks (post-treatment) or 6-, 9-, or 12-month follow-up, controlling for differences in baseline nicotine dependence.","[{'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Box G-S121, Providence, RI, 02912, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Emerson', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Box G-S121, Providence, RI, 02912, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ussher', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Box G-S121, Providence, RI, 02912, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Monti', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Box G-S121, Providence, RI, 02912, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Williams', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Box G-S121, Providence, RI, 02912, USA. david_m_williams@brown.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00236-8']
794,34238835,A Preference-Sensitive Online Instrument to Support Shared Decision Making for Patients With Pelvic Organ Prolapse: A Pilot Multicenter Randomized Controlled Trial.,"A preference-sensitive instrument for women with pelvic organ prolapse was developed to increase shared decision-making. This study aimed to assess the feasibility of a randomized controlled trial to measure the effectiveness of the instrument. A pilot randomized controlled trial was conducted at three Danish gynecological clinics to assess feasibility through recruitment rates, per-protocol use and women's perception of (1) support for decision-making, (2) shared decision-making (Shared Decision-Making Questionnaire), and (3) satisfaction with their decisions. In addition, a focus group interview with participating gynecologists (five gynecologists) was conducted. We invited 226 women and recruited 46 (20%). The most common reason (45%) for nonparticipation was overlooking the invitation in their online public mailbox. Shared Decision-Making Questionnaire showed high data completeness (96%) but indicated a ceiling effect. Women felt the developed instrument supported their decision-making and more so if it was used interactively during consultations. Despite finding the instrument generally useful, gynecologists tended to apply the instrument inconsistently and not per protocol (41%), and some used it as a template for all consultations. This pilot study indicates that recruitment methods, for a future randomized controlled trial, for example, nurse-led preconsultations, need reconsideration due to low recruitment rates and inefficient per-protocol use. In a future randomized controlled trial, cluster randomization should avoid the carryover effect bias.",2021,Shared Decision-Making Questionnaire showed high data completeness (96%) but indicated a ceiling effect.,"['Patients', 'women with pelvic organ prolapse', '226 women and recruited 46 (20']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}]",[],[],226.0,0.159016,Shared Decision-Making Questionnaire showed high data completeness (96%) but indicated a ceiling effect.,"[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Hulbaek', 'Affiliation': 'Author Affiliations: Department of Gynecology and Obstetrics, Hospital of Southern Jutland (Dr Hulbaek), University Hospital of Southern Denmark, Aabenraa; Department of Regional Health Research (Drs Hulbaek, Primdahl, and Birkelund), University of Southern Denmark, Odense; Open Patient data Explorative Network (Dr Hulbaek), OPEN, Odense University Hospital; Danish Hospital for Rheumatic Diseases (Dr Primdahl), University Hospital of Southern Denmark, Soenderborg; Hospital of Southern Jutland (Dr Primdahl), University Hospital of Southern Denmark, Aabenraa; Lillebaelt Hospital (Dr Birkelund), University Hospital of Southern Denmark, Vejle; Department of Gynecology and Obstetrics, Lillebaelt Hospital (Dr Dr Al-kozai), University Hospital of Southern Denmark, Kolding; Department of Gynecology and Obstetrics (Dr Barawi), University Hospital of Southern Denmark, Aabenraa; Department of Gynecology and Obstetrics (Dr Ebbesen), Odense University Hospital; Research Unit for General Practice, Department of Public Health (Dr Nielsen), University of Southern Denmark, Odense; and OPEN Odense Patient data Explorative Network (Dr Hulbaek), Odense University Hospital, and the Region of Southern Denmark.'}, {'ForeName': 'Jette', 'Initials': 'J', 'LastName': 'Primdahl', 'Affiliation': ''}, {'ForeName': 'Regner', 'Initials': 'R', 'LastName': 'Birkelund', 'Affiliation': ''}, {'ForeName': 'Selwan Adnan Hussein', 'Initials': 'SAH', 'LastName': 'Al-Kozai', 'Affiliation': ''}, {'ForeName': 'Sabat', 'Initials': 'S', 'LastName': 'Barawi', 'Affiliation': ''}, {'ForeName': 'Niels Teglhus', 'Initials': 'NT', 'LastName': 'Ebbesen', 'Affiliation': ''}, {'ForeName': 'Jesper Bo', 'Initials': 'JB', 'LastName': 'Nielsen', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000789']
795,34238698,Treatment of axillary bromhidrosis in adolescents by combining electrocauterization with ultrasound-guided botulinum toxin type A injection.,"The aim of this study is to investigate the efficacy of treatment-combined electrocauterization after removal of apocrine sweat glands with ultrasound-guided (BOTOX) injection for adolescents with axillary bromhidrosis. From January 2015 to January 2018, 90 adolescents with axillary bromhidrosis were recruited and randomly divided into three groups (group A, B, and C). Patients in group A underwent electrocauterization after removal of apocrine sweat glands, patients in group B received ultrasound-guided BOTOX injection, and patients in group C had electrocauterization after the removal of apocrine sweat glands followed by ultrasound-guided BOTOX administration after two weeks. All patients were followed up for one year. The percentages of axillary malodor score at twelve months after treatments compared with pre-operation for group A, group B, and group C were 20.2%, 27.5%, and 12.5%, respectively. Significant statistical differences were observed in changes of axillary malodor score among the three groups at three, six, nine and twelve months postoperatively. Satisfaction rates of group A, group B, and group C were 90.0%, 93.3%, and 96.7%, respectively. The side effects after surgery in group A were similar to group C, and no side effect was observed in group B. One-year postoperative scar formation rate of group A was 16.7%, which was significantly higher than that of group B (0) and group C (6.66%). Combination of electrocauterization after removal of apocrine sweat glands with ultrasound-guided BOTOX injection showed better treatment effects.",2021,"The side effects after surgery in group A were similar to group C, and no side effect was observed in group B. One-year postoperative scar formation rate of group A was 16.7%, which was significantly higher than that of group B (0) and group C (6.66%).","['adolescents with axillary bromhidrosis', 'From January 2015 to January 2018, 90 adolescents with axillary bromhidrosis']","['ultrasound-guided botulinum toxin type A injection', 'ultrasound-guided BOTOX injection', 'electrocauterization', 'apocrine sweat glands with ultrasound-guided (BOTOX) injection']","['percentages of axillary malodor score', 'Satisfaction rates', 'axillary malodor score', 'postoperative scar formation rate', 'side effect', 'side effects']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0263472', 'cui_str': 'Bromhidrosis'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4060200', 'cui_str': 'Botulinum Toxin Type A Injection [Botox]'}, {'cui': 'C0700702', 'cui_str': 'Botox'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0930083', 'cui_str': 'Apocrine sweat gland structure'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0334150', 'cui_str': 'Surgical scar'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",90.0,0.0269325,"The side effects after surgery in group A were similar to group C, and no side effect was observed in group B. One-year postoperative scar formation rate of group A was 16.7%, which was significantly higher than that of group B (0) and group C (6.66%).","[{'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Plastic Surgery, The Third Hospital of Jilin University, No.126, Xiantai Street, Erdao District, Changchun, Jilin 130000, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal and Colorectal Surgery, The Third Hospital of Jilin University, No.126, Xiantai Street, Erdao District, Changchun, Jilin 130000, China.'}, {'ForeName': 'Lianbo', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Plastic Surgery, The Third Hospital of Jilin University, No.126, Xiantai Street, Erdao District, Changchun, Jilin 130000, China. Electronic address: lianbo@jlu.edu.cn.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Ultrasound, The Third Hospital of Jilin University, No.126, Xiantai Street, Erdao District, Changchun, Jilin 130000, China. Electronic address: xuyy321@jlu.edu.cn.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2021.03.089']
796,34242837,Rethinking cognitive training: The moderating roles of emotional vulnerability and perceived cognitive impact of training in high worriers.,"Trait worry is a hallmark feature of anxiety and depression, interfering with attentional control and impairing cognitive performance. Previous research has shown the adaptive dual n-back training is effective in improving attentional control and reducing emotional vulnerability, but not for everyone. The current randomised controlled trial explored the role of baseline emotional vulnerability and perceived cognitive impact in training-related cognitive and emotional improvements in 60 high worriers randomly assigned to 10 sessions of the adaptive dual n-back training or non-adaptive 1-back training. Pre-training, post-training and one-month follow-up measures of cognitive performance were assessed using an emotional Flanker task, a cued task-switching task, and the MaRs-IB task. Self-report questionnaires assessed worry, anxiety, depression, somatisation, and self-efficacy, as well as participants' perceived cognitive impact of the training. Participants with higher levels of baseline emotional vulnerability presented the largest improvements in non-verbal reasoning and emotional vulnerability one month after the training, as well as the greatest perceived cognitive impact. Perceived cognitive impact was predicted by working memory improvement on the adaptive n-back training at high baseline levels of anxiety. These results suggest that the adaptive n-back training presents the greatest emotional and cognitive benefits for individuals experiencing severe levels of emotional vulnerability.",2021,"Participants with higher levels of baseline emotional vulnerability presented the largest improvements in non-verbal reasoning and emotional vulnerability one month after the training, as well as the greatest perceived cognitive impact.",['60 high worriers randomly assigned to 10 sessions of the'],"['Rethinking cognitive training', 'adaptive dual n-back training or non-adaptive 1-back training', 'Pre-training, post-training and one-month follow-up measures of cognitive performance were assessed using an emotional Flanker task, a cued task-switching task, and the MaRs-IB task']","['non-verbal reasoning and emotional vulnerability', 'emotional vulnerability', 'Perceived cognitive impact', 'Self-report questionnaires assessed worry, anxiety, depression, somatisation, and self-efficacy']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",60.0,0.0298758,"Participants with higher levels of baseline emotional vulnerability presented the largest improvements in non-verbal reasoning and emotional vulnerability one month after the training, as well as the greatest perceived cognitive impact.","[{'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Ciobotaru', 'Affiliation': 'Department of Psychological Sciences, Birkbeck College, University of London, Malet Street, London, WC1E 7HX, United Kingdom; Department of Psychology and Human Development, UCL Institute of Education, 25 Woburn Square, London, WC1H 0AA, United Kingdom. Electronic address: d.ciobotaru.16@ucl.ac.uk.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Jefferies', 'Affiliation': 'Department of Psychological Sciences, Birkbeck College, University of London, Malet Street, London, WC1E 7HX, United Kingdom.'}, {'ForeName': 'Ludovica', 'Initials': 'L', 'LastName': 'Lispi', 'Affiliation': 'Department of Psychological Sciences, Birkbeck College, University of London, Malet Street, London, WC1E 7HX, United Kingdom.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Derakshan', 'Affiliation': 'Department of Psychological Sciences, Birkbeck College, University of London, Malet Street, London, WC1E 7HX, United Kingdom.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103926']
797,34246347,"Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial.","BACKGROUND


The PI3K/AKT and androgen-receptor pathways are dysregulated in metastatic castration-resistant prostate cancers (mCRPCs); tumours with functional PTEN-loss status have hyperactivated AKT signalling. Dual pathway inhibition with AKT inhibitor ipatasertib plus abiraterone might have greater benefit than abiraterone alone. We aimed to compare ipatasertib plus abiraterone with placebo plus abiraterone in patients with previously untreated mCRPC with or without tumour PTEN loss.
METHODS


We did a randomised, double-blind, phase 3 trial at 200 sites across 26 countries or regions. Patients aged 18 years or older with previously untreated asymptomatic or mildly symptomatic mCRPC who had progressive disease and Eastern Collaborative Oncology Group performance status of 0 or 1 were randomly assigned (1:1; permuted block method) to receive ipatasertib (400 mg once daily orally) plus abiraterone (1000 mg once daily orally) and prednisolone (5 mg twice a day orally) or placebo plus abiraterone and prednisolone (with the same dosing schedule). Patients received study treatment until disease progression, intolerable toxicity, withdrawal from the study, or study completion. Stratification factors were previous taxane-based therapy for hormone-sensitive prostate cancer, type of progression, presence of visceral metastasis, and tumour PTEN-loss status by immunohistochemistry. Patients, investigators, and the study sponsor were masked to the treatment allocation. The coprimary endpoints were investigator-assessed radiographical progression-free survival in the PTEN-loss-by-immunohistochemistry population and in the intention-to-treat population. This study is ongoing and is registered with ClinicalTrials.gov, NCT03072238.
FINDINGS


Between June 30, 2017, and Jan 17, 2019, 1611 patients were screened for eligibility and 1101 (68%) were enrolled; 554 (50%) were assigned to the placebo-abiraterone group and 547 (50%) to the ipatasertib-abiraterone group. At data cutoff (March 16, 2020), median follow-up duration was 19 months (range 0-33). In the 521 (47%) patients who had tumours with PTEN loss by immunohistochemistry (261 in the placebo-abiraterone group and 260 in the ipatasertib-abiraterone group), median radiographical progression-free survival was 16·5 months (95% CI 13·9-17·0) in the placebo-abiraterone group and 18·5 months (16·3-22·1) in the ipatasertib-abiraterone group (hazard ratio [HR] 0·77 [95% CI 0·61-0·98]; p=0·034; significant at α=0·04). In the intention-to-treat population, median progression-free survival was 16·6 months (95% CI 15·6-19·1) in the placebo-abiraterone group and 19·2 months (16·5-22·3) in the ipatasertib-abiraterone group (HR 0·84 [95% CI 0·71-0·99]; p=0·043; not significant at α=0·01). Grade 3 or higher adverse events occurred in 213 (39%) of 546 patients in the placebo-abiraterone group and in 386 (70%) of 551 patients in the ipatasertib-abiraterone group; adverse events leading to discontinuation of placebo or ipatasertib occurred in 28 (5%) in the placebo-abiraterone group and 116 (21%) in the ipatasertib-abiraterone group. Deaths due to adverse events deemed related to treatment occurred in two patients (<1%; acute myocardial infarction [n=1] and lower respiratory tract infection [n=1]) in the placebo-abiraterone group and in two patients (<1%; hyperglycaemia [n=1] and chemical pneumonitis [n=1]) in the ipastasertb-abiraterone group.
INTERPRETATION


Ipatasertib plus abiraterone significantly improved radiographical progression-free survival compared with placebo plus abiraterone among patients with mCRPC with PTEN-loss tumours, but there was no significant difference between the groups in the intention-to-treat population. Adverse events were consistent with the known safety profiles of each agent. These data suggest that combined AKT and androgen-receptor signalling pathway inhibition with ipatasertib and abiraterone is a potential treatment for men with PTEN-loss mCRPC, a population with a poor prognosis.
FUNDING


F Hoffmann-La Roche and Genentech.",2021,Grade 3 or higher adverse events occurred in 213 (39%) of 546 patients in the placebo-abiraterone group and in 386 (70%) of 551 patients in the ipatasertib-abiraterone group; adverse events leading to discontinuation of placebo or ipatasertib occurred in 28 (5%) in the placebo-abiraterone group and 116 (21%) in the ipatasertib-abiraterone group.,"['men with PTEN-loss mCRPC, a population with a poor prognosis', 'metastatic castration-resistant prostate cancer (IPATential150', '0·77', 'Patients aged 18 years or older with previously untreated asymptomatic or mildly symptomatic mCRPC who had progressive disease and Eastern Collaborative Oncology Group performance status of 0 or 1', 'patients with mCRPC with PTEN-loss tumours', 'patients with previously untreated mCRPC with or without tumour PTEN loss', '200 sites across 26 countries or regions', 'Between June 30, 2017, and Jan 17, 2019, 1611 patients were screened for eligibility and 1101 (68%) were enrolled; 554 (50']","['ipatasertib-abiraterone', 'Ipatasertib plus abiraterone and prednisolone', 'placebo-abiraterone', 'prednisolone', 'ipatasertib plus abiraterone with placebo plus abiraterone', 'taxane-based therapy', 'placebo plus abiraterone and prednisolone', 'placebo plus abiraterone', 'ipatasertib (400 mg once daily orally) plus abiraterone']","['median radiographical progression-free survival', 'radiographical progression-free survival', 'median progression-free survival', 'Adverse events', 'acute myocardial infarction', 'Grade 3 or higher adverse events', 'investigator-assessed radiographical progression-free survival in the PTEN-loss-by-immunohistochemistry population and in the intention-to-treat population']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1430988', 'cui_str': 'PTEN protein, human'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C3712838', 'cui_str': '2-(4-chlorophenyl)-1-(4-(7-hydroxy-5-methyl-6,7-dihydro-5H-cyclopenta(d)pyrimidin-4-yl)piperazin-1-yl)-3-(isopropylamino)propan-1-one'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1430988', 'cui_str': 'PTEN protein, human'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",1611.0,0.708377,Grade 3 or higher adverse events occurred in 213 (39%) of 546 patients in the placebo-abiraterone group and in 386 (70%) of 551 patients in the ipatasertib-abiraterone group; adverse events leading to discontinuation of placebo or ipatasertib occurred in 28 (5%) in the placebo-abiraterone group and 116 (21%) in the ipatasertib-abiraterone group.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sweeney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Azienda Ospedaliera Santa Maria, Terni, Italy.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, New York-Presbyterian, New York City, NY, USA.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': 'Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Massard', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'P A Herzen Moscow Oncology Research Institute, Moscow, Russia.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Parnis', 'Affiliation': 'Ashford Cancer Centre Research, Kurralta Park, SA, Australia.'}, {'ForeName': 'Vagif', 'Initials': 'V', 'LastName': 'Atduev', 'Affiliation': 'Volga District Medical Centre under Federal Medical and Biological Agency of Russia, Nizhny Novgorod, Russia.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Buchschacher', 'Affiliation': 'Kaiser Permanente Southern California, Los Angeles Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Rustem', 'Initials': 'R', 'LastName': 'Gafanov', 'Affiliation': 'Russian Scientific Center of Roentgenology and Radiology, Moscow, Russia.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Corrales', 'Affiliation': 'Medical Oncology, Centro de Investigación y Manejo del Cáncer CIMCA, San José, Costa Rica.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borre', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Daniil', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital Number 62 of Moscow Healthcare Department, Moscow Oblast, Russia.'}, {'ForeName': 'Gustavo Vasconcelos', 'Initials': 'GV', 'LastName': 'Alves', 'Affiliation': 'Centro Integrado de Pesquisa em Oncologia, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Bournakis', 'Affiliation': 'Oncologic Clinical Trials and Research Clinic, Metropolitan General Hospital, Athens, Greece.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Puente', 'Affiliation': 'Medical Oncology Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), CIBERONC, Madrid, Spain.'}, {'ForeName': 'Marie-Laurence', 'Initials': 'ML', 'LastName': 'Harle-Yge', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gallo', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hanover', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Wongchenko', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Garcia', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Johann S', 'Initials': 'JS', 'LastName': 'de Bono', 'Affiliation': 'Division of Clinical Studies, The Institute of Cancer Research, London, UK; Drug Development Unit, Royal Marsden Hospital, Sutton, UK. Electronic address: johann.de-bono@icr.ac.uk.'}]","Lancet (London, England)",['10.1016/S0140-6736(21)00580-8']
798,34250911,Comparison between effectiveness of dentine desensitizer and one bottle self-etch adhesive on dentine hypersensitivity.,"BACKGROUND


Dentine hypersensitivity is one of the most common chief complaints of patients observed by dentists in their practice. However, there is a lack of universal consensus over the selection of reliable treatment modality.
OBJECTIVES


To compare the effectiveness between dentine desensitizer and self-etch adhesive in patients complaining of moderate to severe dentine hypersensitivity pain.
METHODS


A total of 254 patients with moderate to severe dentine hypersensitivity were randomly divided into Group A (Single Bond Universal Agent) and Group B (Seal & Protect Agent) according to the treatment provided. Sensitivity was assessed by means of mechanical (probing) and evaporative (air blast) stimuli. Discomfort Internal Scale (DIS) was explained to patients. DIS scores were recorded after one minute and one month following the application of both agents. Descriptive statistics were calculated. Stratification was done to control confounder and post stratification chi-square test was also applied.
RESULT


The statistically significant difference (p= 0.000) in effectiveness between the two groups was observed. The mean discomfort internal scale score at baseline, after 1 minute and after 1 month in Group A was 3.65 ± 0.60, 2.33 ± 0.64 and 0.41 ± 0.71 respectively, while in Group B, it was 3.55 ± 0.58, 2.40 ± 0.62 and 0.72 ± 0.92 respectively. Overall, 86.6% patients observed improvement in dentinal sensitivity in Group A while in Group B only 67.7% patients reported reduction in sensitivity.
CONCLUSION


Self-etch adhesive significantly reduces dentin hypersensitivity, immediately after one minute of its application and is effective for a period of one month compared to desensitizing agent.",2021,"CONCLUSION


Self-etch adhesive significantly reduces dentin hypersensitivity, immediately after one minute of its application and is effective for a period of one month when compared to desensitizing agent.","['A total 254 patients', 'patients complaining of moderate to severe dentine hypersensitivity pain']","['dentine desensitizer', 'Group A (Single Bond Universal Agent) and Group B (Seal & Protect Agent', 'dentine desensitizer and self-etch adhesive']","['mean discomfort internal scale score', 'dentin hypersensitivity', 'dentine hypersensitivity', 'dentinal sensitivity', 'sensitivity', 'Sensitivity', 'mechanical (probing) and evaporative (air blast) stimuli', 'DIS scores', 'Discomfort Internal Scale (DIS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0759863', 'cui_str': 'single bond'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",254.0,0.021993,"CONCLUSION


Self-etch adhesive significantly reduces dentin hypersensitivity, immediately after one minute of its application and is effective for a period of one month when compared to desensitizing agent.","[{'ForeName': 'Muhammad Zohaib', 'Initials': 'MZ', 'LastName': 'Younus', 'Affiliation': 'Department of Operative Dentistry, Fatima Jinnah Dental College, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Adeel', 'Initials': 'MA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Restorative Dentistry and Endodontics, College of Dentistry, King Faisal University, Al-Ahsa, Saudi Arabia.'}, {'ForeName': 'Azeem Ul Yaqin', 'Initials': 'AUY', 'LastName': 'Syed', 'Affiliation': 'Department of Prosthodontics, Fatima Jinnah Dental College, Karachi, Pakistan.'}, {'ForeName': 'Jiand Malik', 'Initials': 'JM', 'LastName': 'Baloch', 'Affiliation': 'Department of Operative Dentistry, Bolan University of Medical and Health Sciences, Quetta, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Department of Operative Dentistry, Fatima Jinnah Dental College, Karachi, Pakistan.'}, {'ForeName': 'Abubakar', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Department of Endodontics, Fatima Jinnah Dental College, Karachi, Pakistan.'}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-202636']
799,34252124,Transcutaneous auricular VNS applied to experimental pain: A paired behavioral and EEG study using thermonociceptive CO2 laser.,"BACKGROUND


Transcutaneous auricular Vagal Nerve Stimulation (taVNS) is a non-invasive neurostimulation technique with potential analgesic effects. Several studies based on subjective behavioral responses suggest that taVNS modulates nociception differently with either pro-nociceptive or anti-nociceptive effects.
OBJECTIVE


This study aimed to characterize how taVNS alters pain perception, by investigating its effects on event-related potentials (ERPs) elicited by different types of spinothalamic and lemniscal somatosensory stimuli, combined with quantitative sensory testing (detection threshold and intensity ratings).
METHODS


We performed 3 experiments designed to study the time-dependent effects of taVNS and compare with standard cervical VNS (cVNS). In Experiment 1, we assessed the effects of taVNS after 3 hours of stimulation. In Experiment 2, we focused on the immediate effects of the duty cycle (OFF vs. ON phases). Experiments 1 and 2 included 22 and 15 healthy participants respectively. Both experiments consisted of a 2-day cross-over protocol, in which subjects received taVNS and sham stimulation sequentially. In addition, subjects received a set of nociceptive (thermonociceptive CO2 laser, mechanical pinprick) and non-nociceptive (vibrotactile, cool) stimuli, for which we recorded detection thresholds, intensity of perception and ERPs. Finally, in Experiment 3, we tested 13 epileptic patients with an implanted cVNS by comparing OFF vs. ON cycles, using a similar experimental procedure.
RESULTS


Neither taVNS nor cVNS appeared to modulate the cerebral and behavioral aspects of somatosensory perception.
CONCLUSION


The potential effect of taVNS on nociception requires a cautious interpretation, as we found no objective change in behavioral and cerebral responses to spinothalamic and lemniscal somatosensory stimulations.",2021,"Neither taVNS nor cVNS appeared to modulate the cerebral and behavioral aspects of somatosensory perception.
","['Experiments 1 and 2 included 22 and 15 healthy participants respectively', '13 epileptic patients with an', 'experimental pain']","['thermonociceptive CO2 laser', 'standard cervical VNS (cVNS', 'taVNS', 'implanted cVNS', 'Transcutaneous auricular VNS', 'nociceptive (thermonociceptive CO2 laser, mechanical pinprick) and non-nociceptive (vibrotactile, cool) stimuli', 'Transcutaneous auricular Vagal Nerve Stimulation (taVNS']",[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",[],13.0,0.0216818,"Neither taVNS nor cVNS appeared to modulate the cerebral and behavioral aspects of somatosensory perception.
","[{'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Dumoulin', 'Affiliation': 'Institute of Neuroscience, Université Catholique de Louvain (UCLouvain), Brussels, Belgium.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Liberati', 'Affiliation': 'Institute of Neuroscience, Université Catholique de Louvain (UCLouvain), Brussels, Belgium.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Mouraux', 'Affiliation': 'Institute of Neuroscience, Université Catholique de Louvain (UCLouvain), Brussels, Belgium.'}, {'ForeName': 'Susana Ferrao', 'Initials': 'SF', 'LastName': 'Santos', 'Affiliation': 'Institute of Neuroscience, Université Catholique de Louvain (UCLouvain), Brussels, Belgium.'}, {'ForeName': 'Riëm', 'Initials': 'R', 'LastName': 'El Tahry', 'Affiliation': 'Institute of Neuroscience, Université Catholique de Louvain (UCLouvain), Brussels, Belgium.'}]",PloS one,['10.1371/journal.pone.0254480']
800,34254233,Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia: A Trial Protocol for a Multicenter Randomized Controlled Trial.,"INTRODUCTION


The chronic neuropathic pain associated with postherpetic neuralgia (PHN) can last for several months or even many years, seriously affecting the affected person's work, sleep, mood, and daily life activities. In generaly, current treatments for PHN are at best limited and unsatisfactory, and adverse reactions are common, especially in elderly patients. Electroacupuncture (EA) is widely used clinically to manage painful diseases, but there remains a lack of evidence to support the effectiveness of EA on PHN. This study is designed to assess the efficacy and safety of EA on PHN, and to provide evidence-based medical evidence for EA treatment of PHN.
METHODS


This multicenter, prospective, randomized controlled trial will recruit 448 patients with PHN at seven clinical centers. Multicenter stratified variable block randomization will be used, and the eligible patients will be randomly allocated in a ratio of 1:1 to the EA group or sham EA group. The EA group will receive 4 weeks of EA treatment, given as 30-min treatment sessions, once daily, 5 times per week, for a total of 20 treatments; the sham EA group will receive sham EA treatment under the same conditions.
PLANNED OUTCOMES


The primary outcome measure is the 11-point Numeric Rating Scale pain score at week 4. The secondary outcome measures, including mechanical pain threshold, pain area of PHN, average number of pain episodes, the short-form McGill Pain Questionnaire 2, Zoster Brief Pain Inventory, the Depression, Anxiety, and Positive Outlook Scale, Patient Global Impression of Change, safety of EA, and use of concomitant medications, among others. The primary analysis of the outcomes will be the mixed-effect model with repeated measurement between groups on an intent-to-treat population.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT04560361. Registered 23 September 2020 ( https://clinicaltrials.gov/ct2/show/NCT04560361?term=NCT04560361&draw=2&rank=1 ).",2021,"PLANNED OUTCOMES


","['Postherpetic Neuralgia', '448 patients with PHN at seven clinical centers', 'elderly patients']","['sham EA group will receive sham EA', 'Electroacupuncture', 'Electroacupuncture (EA', 'EA group or sham EA']","['11-point Numeric Rating Scale pain score', 'chronic neuropathic pain', 'mechanical pain threshold, pain area of PHN, average number of pain episodes, the short-form McGill Pain Questionnaire 2, Zoster Brief Pain Inventory, the Depression, Anxiety, and Positive Outlook Scale, Patient Global Impression of Change, safety of EA, and use of concomitant medications']","[{'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",448.0,0.31245,"PLANNED OUTCOMES


","[{'ForeName': 'Qianyan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Hezhuang Street Community Health Service Center, Hangzhou, 311222, Zhejiang, China.'}, {'ForeName': 'Bingyang', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Xia', 'Affiliation': 'Department of Acupuncture, Affiliated Hospital of Nantong University, Nantong, 226001, Jiangsu, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, Jiangsu, China. 11801758@qq.com.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, Jiangsu, China. jhsun@njucm.edu.cn.'}]",Pain and therapy,['10.1007/s40122-021-00283-8']
801,34255891,Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis.,"BACKGROUND


Treating to absolute treatment targets rather than relative measures such as Psoriasis Area and Severity Index (PASI)-75 is emerging as an important clinical concept included in psoriasis guidelines and clinical practice. Achieving treatment targets is associated with achievement of long-term outcomes.
OBJECTIVE


To evaluate the relationship between psoriasis severity, disease characteristics and achievement of PASI ≤2 with apremilast in a pooled analysis of the phase 3 ESTEEM 1 and 2 (NCT01194219 and NCT01232283), phase 3b LIBERATE (NCT01690299) and phase 4 UNVEIL (NCT02425826) clinical trials.
METHODS


Pooled data from patients with moderate-to-severe plaque psoriasis randomized to apremilast 30 mg BID were analysed by baseline PASI quartiles (Q1: 2.4-13.1; Q2: 13.2-15.9; Q3: 16.0-20.0; Q4: 20.1-57.8). Assessments included PASI, Dermatology Life Quality Index (DLQI), Scalp Physician's Global Assessment (ScPGA; ScPGA ≥1) and target (worst) Nail Psoriasis Severity Index (NAPSI; NAPSI ≥1).
RESULTS


Of 1062 patients, 963 had ScPGA ≥1 and 643 had NAPSI ≥1; 771 patients with baseline and Week 32 PASI assessments were included in analyses of Week 32 PASI target achievement. Rates of PASI ≤2 at Week 32 were greater in lower PASI quartiles (Q1: 43.5%; Q2: 31.2%; Q3: 26.8%; Q4: 18.4%). Most patients achieving PASI ≤2 target (83.6%) achieved DLQI ≤5 at Week 32; 59.3% of patients who did not achieve PASI ≤2 target achieved DLQI ≤5. At Week 32, mean improvements in ScPGA and NAPSI were similar with more moderate vs. more severe disease (ScPGA, range: 1.1-1.4; NAPSI, range: 1.6-2.5). In a subgroup analysis, achievement of PASI ≤2 target was higher in the lowest PASI quartile and with disease duration <5 years.
CONCLUSIONS


Greater achievement of PASI ≤2 was observed in patients with more moderate vs. more severe skin disease. Apremilast may be particularly beneficial in more moderate disease early in the treatment paradigm.",2021,"Rates of PASI ≤2 at Week 32 were greater in lower PASI quartiles (Q1: 43.5%, Q2: 31.2%, Q3: 26.8%, Q4: 18.4%).","['1,062 patients', 'patients with moderate to severe plaque psoriasis randomized to apremilast 30 mg BID were analyzed by baseline PASI quartiles (Q1: 2.4-13.1, Q2: 13.2-15.9, Q3: 16.0-20.0, Q4: 20.1-57.8', ' 963 had ScPGA ≥1 and 643 had NAPSI ≥1, 771 patients with baseline and Week 32 PASI assessments']",[],"['Psoriasis Area and Severity Index', 'severe skin disease', 'DLQI', 'Rates of PASI', 'ScPGA and NAPSI', ""PASI, Dermatology Life Quality Index (DLQI), Scalp Physician's Global Assessment (ScPGA, ScPGA ≥1), and target (worst) Nail Psoriasis Severity Index (NAPSI, NAPSI ≥1""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C3819585', 'cui_str': 'apremilast 30 MG [Otezla]'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],"[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}]",771.0,0.0936288,"Rates of PASI ≤2 at Week 32 were greater in lower PASI quartiles (Q1: 43.5%, Q2: 31.2%, Q3: 26.8%, Q4: 18.4%).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'University Medical Center Schleswig-Holstein Campus, Kiel, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'C E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'The Dermatology Centre, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': 'Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Strober', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Nunez Gomez', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Shi', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Guerette', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.17520']
802,34259565,Low Carbohydrate Diets and Estimated Cardiovascular and Metabolic Syndrome Risk in Prostate Cancer.,"PURPOSE


A low carbohydrate diet (LCD) was shown to suggestively slow prostate cancer (PC) growth. In noncancer patients, LCDs improve metabolic syndrome (MetS) without weight loss. However, concerns about negative impact on cardiovascular disease (CVD) risk remain. The objective of this secondary analysis is to determine the impact of an LCD on risk of MetS and estimated CVD risk in patients with PC.
MATERIALS AND METHODS


Pooled data were analyzed from 2 randomized trials testing LCD vs control on 1) preventing insulin resistance after starting hormone therapy (CAPS1) and 2) slowing PC growth in recurrent PC after failed primary treatment (CAPS2). Both trials included a usual care control vs LCD intervention in which patients were instructed to limit carbohydrate intake to ≤20 gm/day, and in CAPS1 only, to walk for ≥30 minutes/day for ≥5 days/week. MetS components (hypertension, high triglycerides, low high-density lipoprotein cholesterol, central obesity and diabetes), 10-year CVD risk estimated using the Framingham Score with either body mass index (BMI) or lipids, and remnant cholesterol were compared between arms using mixed models adjusting for trial.
RESULTS


LCD resulted in a significantly reduced risk of MetS (p=0.004) and remnant cholesterol (p <0.001). Moreover, LCD resulted in significantly lower estimated CVD risk using BMI (p=0.002) over the study with no difference in estimated CVD risk using lipids (p=0.14).
CONCLUSIONS


LCD resulted in a significantly reduced risk of MetS and remnant cholesterol, and a significantly lower estimated CVD risk using BMI. By comparison, there was no difference in estimated CVD risk using lipids. Study limitations include small sample size, short followup, and inability to distinguish effects of carbohydrate restriction and weight loss. Long-term studies are needed to confirm this finding.",2021,LCD resulted in a significantly reduced risk of MetS (p=0.004) and remnant cholesterol (p<0.001).,"['PC patients', 'Prostate Cancer']","['low carbohydrate diet (LCD', 'Low Carbohydrate Diets', 'usual care control vs LCD intervention', 'LCD']","['risk of MetS', 'CVD risk using BMI', 'MetS components (hypertension, high triglycerides, low HDL, central obesity and diabetes), ten-year CVD risk estimated using the Framingham Score with either BMI or lipids, and remnant cholesterol', 'remnant cholesterol', 'insulin resistance', 'risk of MetS and estimated CVD risk']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.112793,LCD resulted in a significantly reduced risk of MetS (p=0.004) and remnant cholesterol (p<0.001).,"[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Center for Integrated Research on Cancer and Lifestyle, Department of Surgery, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Howard', 'Affiliation': 'Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ngo', 'Affiliation': 'Center for Integrated Research on Cancer and Lifestyle, Department of Surgery, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California.'}, {'ForeName': 'Adela', 'Initials': 'A', 'LastName': 'Ramirez-Torres', 'Affiliation': 'Center for Integrated Research on Cancer and Lifestyle, Department of Surgery, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Csizmadi', 'Affiliation': 'Center for Integrated Research on Cancer and Lifestyle, Department of Surgery, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Mack', 'Affiliation': 'Center for Integrated Research on Cancer and Lifestyle, Department of Surgery, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California.'}, {'ForeName': 'Pao-Hwa', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Nephrology Division, Duke University Medical Center, Durham, North Carolina.'}]",The Journal of urology,['10.1097/JU.0000000000002112']
803,34216395,Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study.,"OBJECTIVE


We analyzed the efficacy and safety of an everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) versus mycophenolic acid with standard-exposure CNI (MPA+sCNI) regimen in Asian patients from the TRANSFORM study.
METHODS


In this 24-month, open-label study, de novo kidney transplant recipients (KTxRs) were randomized (1:1) to receive EVR+rCNI or MPA+sCNI, along with induction therapy and corticosteroids.
RESULTS


Of the 2037 patients randomized in the TRANSFORM study, 293 were Asian (EVR+rCNI, N = 136; MPA+sCNI, N = 157). At month 24, EVR+rCNI was noninferior to MPA+sCNI for the binary endpoint of estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m 2  or treated biopsy-proven acute rejection (27.0% vs. 29.2%, P = .011 for a noninferiority margin of 10%). Graft loss and death were reported for one patient each in both arms. Mean eGFR was higher in EVR+rCNI versus MPA+sCNI (72.2 vs. 66.3 ml/min/1.73 m 2  , P = .0414) even after adjusting for donor type and donor age (64.3 vs. 59.3 ml/min/1.73 m 2  , P = .0582). Overall incidence of adverse events was comparable. BK virus (4.4% vs. 12.1%) and cytomegalovirus (4.4% vs. 13.4%) infections were significantly lower in the EVR+rCNI arm.
CONCLUSION


This subgroup analysis in Asian de novo KTxRs demonstrated that the EVR+rCNI versus MPA+sCNI regimen provides comparable antirejection efficacy, better renal function, and reduced viral infections (NCT01950819).",2021,"At Month 24, EVR+rCNI was noninferior to MPA+sCNI for the binary endpoint of estimated glomerular filtration rate (eGFR)","['Asian de novo kidney transplant recipients', 'Asian patients from the TRANSFORM study', 'novo kidney transplant recipients (KTxRs', '2037 patients randomized in the TRANSFORM study, 293 were Asian (EVR+rCNI, N = 136; MPA+sCNI, N = 157']","['EVR+rCNI', 'Everolimus-facilitated calcineurin inhibitor reduction', 'EVR+rCNI or MPA+sCNI, along with induction therapy and corticosteroids', 'everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) versus mycophenolic acid with standard-exposure CNI (MPA+sCNI) regimen']","['efficacy and safety', 'antirejection efficacy, better renal function and reduced viral infections', 'glomerular filtration rate (eGFR', 'cytomegalovirus', 'Graft loss and death', 'Overall incidence of adverse events', 'Mean eGFR', 'acute rejection']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1431767', 'cui_str': 'cni protein, Drosophila'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1431767', 'cui_str': 'cni protein, Drosophila'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}]",2037.0,0.0579305,"At Month 24, EVR+rCNI was noninferior to MPA+sCNI for the binary endpoint of estimated glomerular filtration rate (eGFR)","[{'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Watarai', 'Affiliation': 'Department of Transplant Surgery, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Danguilan', 'Affiliation': 'Department of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.'}, {'ForeName': 'Concesa', 'Initials': 'C', 'LastName': 'Casasola', 'Affiliation': 'Department of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.'}, {'ForeName': 'Shen-Shin', 'Initials': 'SS', 'LastName': 'Chang', 'Affiliation': 'Department of Surgery, National Cheng Kung University College of Medicine and Hospital, Tainan, Taiwan.'}, {'ForeName': 'Prajej', 'Initials': 'P', 'LastName': 'Ruangkanchanasetr', 'Affiliation': 'Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Kee', 'Affiliation': 'Department of Renal Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Hin Seng', 'Initials': 'HS', 'LastName': 'Wong', 'Affiliation': 'Department of Nephrology & Clinical Research Centre Hospital Selayang, Selangor Darul Ehsan, Batu Caves, Malaysia.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kenmochi', 'Affiliation': 'Department of Transplant Surgery, Fujita Health University Hospital, Toyoake, Japan.'}, {'ForeName': 'Angel Joaquin', 'Initials': 'AJ', 'LastName': 'Amante', 'Affiliation': 'Department of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.'}, {'ForeName': 'Kuo-Hsiung', 'Initials': 'KH', 'LastName': 'Shu', 'Affiliation': 'Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Atiporn', 'Initials': 'A', 'LastName': 'Ingsathit', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bernhardt', 'Affiliation': 'Department of Research and Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'Hernandez-Gutierrez', 'Affiliation': 'Department of Research and Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Duck Jong', 'Initials': 'DJ', 'LastName': 'Han', 'Affiliation': 'Department of General Surgery, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Myoung Soo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Clinical transplantation,['10.1111/ctr.14415']
804,34214614,Anorectal dose-effect relations for late gastrointestinal toxicity following external beam radiotherapy for prostate cancer in the FLAME trial.,"BACKGROUND AND PURPOSE


The phase III FLAME trial (NCT01168479) showed an increase in five-year biochemical disease-free survival, with no significant increase in toxicity when adding a focal boost to external beam radiotherapy (EBRT) for localized prostate cancer [Kerkmeijer et al. JCO 2021]. The aim of this study was to investigate the association between delivered radiation dose to the anorectum and gastrointestinal (GI) toxicity (grade ≥2).
MATERIAL AND METHODS


All patients in the FLAME trial were analyzed, irrespective of treatment arm. The dose-effect relation of the anorectal dose parameters (D2cm 3  and D50%) and GI toxicity grade ≥2 in four years of follow-up was assessed using a mixed model analysis for repeated measurements, adjusted for age, cardiovascular disease, diabetes mellitus, T-stage, baseline toxicity grade ≥1, hormonal therapy and institute.
RESULTS


A dose-effect relation for D2cm 3  and D50% was observed with adjusted odds ratios of 1.17 (95% CI 1.13-1.21, p < 0.0001) and 1.20 (95% CI 1.14-1.25, p < 0.0001) for GI toxicity, respectively.
CONCLUSION


Although there was no difference in toxicity between study arms, a higher radiation dose to the anorectum was associated with a statistically significant increase in GI toxicity following EBRT for prostate cancer. This dose-effect relation was present for both large and small anorectal volumes. Therefore, further increase in dose to the anorectum should be weighed against the benefit of focal dose escalation for prostate cancer.",2021,"Although there was no difference in toxicity between study arms, a higher radiation dose to the anorectum was associated with a statistically significant increase in GI toxicity following EBRT for prostate cancer.","['localized prostate cancer', 'All patients in the FLAME trial']","['external beam radiotherapy (EBRT', 'external beam radiotherapy']","['five-year biochemical disease-free survival', 'GI toxicity', 'toxicity', 'GI toxicity grade ≥2', 'anorectum and gastrointestinal (GI) toxicity (grade ≥2']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.132476,"Although there was no difference in toxicity between study arms, a higher radiation dose to the anorectum was associated with a statistically significant increase in GI toxicity following EBRT for prostate cancer.","[{'ForeName': 'Veerle H', 'Initials': 'VH', 'LastName': 'Groen', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, The Netherlands.'}, {'ForeName': 'Nicolaas P A', 'Initials': 'NPA', 'LastName': 'Zuithoff', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, The Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'van Schie', 'Affiliation': 'The Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Evelyn M', 'Initials': 'EM', 'LastName': 'Monninkhof', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, The Netherlands.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kunze-Busch', 'Affiliation': 'Radboud University Medical Centre, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Hans C J', 'Initials': 'HCJ', 'LastName': 'de Boer', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, The Netherlands.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'van der Voort van Zyp', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, The Netherlands.'}, {'ForeName': 'Floris J', 'Initials': 'FJ', 'LastName': 'Pos', 'Affiliation': 'The Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'Smeenk', 'Affiliation': 'Radboud University Medical Centre, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Haustermans', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Belgium.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Isebaert', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Belgium.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Draulans', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Belgium.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Depuydt', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Belgium.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'University Medical Center, Imaging Division, Utrecht, The Netherlands.'}, {'ForeName': 'Uulke A', 'Initials': 'UA', 'LastName': 'van der Heide', 'Affiliation': 'The Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Linda G W', 'Initials': 'LGW', 'LastName': 'Kerkmeijer', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, The Netherlands; Radboud University Medical Centre, Radiation Oncology, Nijmegen, The Netherlands. Electronic address: linda.kerkmeijer@radboudumc.nl.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.06.033']
805,34214153,Phosphate Concentrations and Modifying Factors in Healthy Children From 12 to 24 Months of Age.,"CONTEXT


Phosphate homeostasis and its modifiers in early childhood are inadequately characterized.
OBJECTIVE


To determine physiological plasma phosphate concentration and modifying factors in healthy infants at 12 to 24 months of age.
DESIGN


This study included 525 healthy infants (53% girls), who participated in a randomized vitamin D intervention trial and received daily vitamin D3 supplementation of either 10 or 30 μg from age 2 weeks to 24 months. Biochemical parameters were measured at 12 and 24 months. Dietary phosphate intake was determined at 12 months.
MAIN OUTCOME MEASURES


Plasma phosphate concentrations at 12 and 24 months of age.
RESULTS


Mean (SD) phosphate concentration decreased from 12 months (1.9 ± 0.15 mmol/L) to 24 months (1.6 ± 0.17 mmol/L) of age (P < 0.001 for repeated measurements). When adjusted by covariates, such as body size, creatinine, serum 25-hydroxyvitamin D, intact and C-terminal fibroblast growth factor 23, mean plasma phosphate was higher in boys than girls during follow-up (P = 0.019). Phosphate concentrations were similar in the vitamin D intervention groups (P > 0.472 for all). Plasma iron was associated positively with plasma phosphate at both time points (B, 0.006 and 0.005; 95% CI, 0.004-0.009 and 0.002-0.008; P < 0.001 at both time points, respectively). At 24 months of age, the main modifier of phosphate concentration was plasma creatinine (B, 0.007; 95% CI 0.003-0.011, P < 0.001).
CONCLUSION


Plasma phosphate concentration decreased from age 12 to 24 months. In infants and toddlers, the strongest plasma phosphate modifiers were sex, iron, and creatinine, whereas vitamin D supplementation did not modify phosphate concentrations.",2021,Phosphate concentrations were similar in the vitamin D intervention groups (p>0.472 for all).,"['healthy infants at 12 to 24 months of age', '525 healthy infants (53% girls), who participated in a randomized vitamin D intervention (VIDI) trial and received', 'healthy children from 12 to 24 months of age']","['vitamin D intervention', 'daily vitamin D3 supplementation']","['Dietary phosphate intake', 'Plasma phosphate concentrations', 'Mean (SD) phosphate concentration', 'Plasma phosphate concentration', 'Phosphate concentrations', 'body size, creatinine, 25OHD, intact and C-terminal FGF23, mean plasma phosphate', 'Biochemical parameters']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0559872', 'cui_str': 'Phosphorus intake'}, {'cui': 'C0858147', 'cui_str': 'Plasma phosphate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0005901', 'cui_str': 'Body Size'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C3272931', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",525.0,0.0734785,Phosphate concentrations were similar in the vitamin D intervention groups (p>0.472 for all).,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Koljonen', 'Affiliation': 'Folkhälsan Research Center, 00290 Helsinki, Finland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Enlund-Cerullo', 'Affiliation': 'Folkhälsan Research Center, 00290 Helsinki, Finland.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hauta-Alus', 'Affiliation': 'Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, 00014 Helsinki, Finland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Holmlund-Suila', 'Affiliation': 'Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, 00014 Helsinki, Finland.'}, {'ForeName': 'Saara', 'Initials': 'S', 'LastName': 'Valkama', 'Affiliation': 'Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, 00014 Helsinki, Finland.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Rosendahl', 'Affiliation': 'Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, 00014 Helsinki, Finland.'}, {'ForeName': 'Sture', 'Initials': 'S', 'LastName': 'Andersson', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, 00014 Helsinki, Finland.""}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Pekkinen', 'Affiliation': 'Folkhälsan Research Center, 00290 Helsinki, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Mäkitie', 'Affiliation': 'Folkhälsan Research Center, 00290 Helsinki, Finland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab495']
806,34229554,Clinical development and evaluation of a VEGF-D assay in plasma from patients with metastatic colorectal cancer in the RAISE study.,"BACKGROUND


Vascular endothelial growth factor (VEGF)-D was identified as a potential predictive biomarker for ramucirumab efficacy in second-line metastatic colorectal cancer using a research use only (RUO) assay. We describe results with a new assay for detecting VEGF-D in human plasma.
METHODS


In RAISE (Clinical Trial Registration: NCT01183780), 1072 patients were randomized 1:1 to ramucirumab or placebo plus FOLFIRI. All patients were then randomized 1:2 to marker exploratory (ME) and marker confirmatory (MC) groups, and those with plasma samples were analyzed accordingly. A new assay validated for investigational use only (IUO) was used to measure VEGF-D levels in plasma, which were analyzed for correlation with overall and progression-free survival (OS/PFS). IUO assay data were compared with historical RUO assay data.
RESULTS


ME subset analyses determined the optimal cutpoint of 5.4 ng/mL for defining high/low VEGF-D subgroups. In the combined ME/MC placebo arms, OS/PFS were numerically greater for patients with low vs high VEGF-D (OS: 12.8 vs 11.1 months; PFS: 5.6 vs 4.2 months). In patients with high VEGF-D, ramucirumab vs placebo demonstrated a numerically greater improvement in OS and PFS. Differential efficacy by VEGF-D level was statistically significant for PFS, but not OS.
CONCLUSION


In patients with high VEGF-D, ramucirumab demonstrated a greater improvement in OS and PFS vs placebo; however, baseline VEGF-D level was not predictive of ramucirumab OS benefit using VEGF-D assay for IUO. The RAISE intent-to-treat results remain valid.",2021,"In patients with high VEGF-D, ramucirumab versus placebo demonstrated a numerically greater improvement in OS and PFS.","['1072 patients', 'patients with metastatic colorectal cancer']","['VEGF-D assay', 'ramucirumab or placebo plus FOLFIRI', 'placebo', 'combined ME/MC placebo']","['OS/PFS', 'VEGF-D levels in plasma', 'Differential efficacy by VEGF-D level', 'OS and PFS', 'baseline VEGF-D level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor-D'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor-D'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",1072.0,0.134844,"In patients with high VEGF-D, ramucirumab versus placebo demonstrated a numerically greater improvement in OS and PFS.","[{'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shunt-gun, Japan.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Nixon', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Barcelona, Spain.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Digestive Oncology, University Hospitals Leuven and Kuleuven, Leuven, Belgium.'}, {'ForeName': 'Kim R', 'Initials': 'KR', 'LastName': 'Robling', 'Affiliation': 'Clinical Diagnostics Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Paolo B', 'Initials': 'PB', 'LastName': 'Abada', 'Affiliation': 'Oncology Division, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Hozak', 'Affiliation': 'Oncology Business Unit - Patient Tailoring & Global Strategic Planning, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Siegel', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Fill', 'Affiliation': 'Clinical Diagnostics Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Wijayawardana', 'Affiliation': 'Statistics - Oncology, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Walgren', 'Affiliation': 'Oncology Division, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Giles', 'Affiliation': 'Corgenix Inc., Broomfield, CO, USA.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Corgenix Inc., Broomfield, CO, USA.'}, {'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Pitts', 'Affiliation': 'Corgenix Inc., Broomfield, CO, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Drove', 'Affiliation': 'Oncology Division, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}]",Current medical research and opinion,['10.1080/03007995.2021.1940908']
807,34232005,Fixed-Combination Halobetasol Propionate and Tazarotene Lotion for Psoriasis in Patients With Skin of Color.,"BACKGROUND


Few studies have examined topical psoriasis therapies in patients with skin of color. Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) was investigated in two phase 3, multicenter, double-blind, vehicle-controlled trials (NCT02462070; NCT02462122). This post hoc analysis evaluated HP/TAZ in subgroups of non-White and White participants, including Hispanic/Latino participants, from these trials.
METHODS


Adult participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once daily for 8 weeks. Data were pooled and analyzed in non-mutually exclusive subgroups of self-identified non-White or White and Hispanic/Latino participants. Efficacy assessments included treatment success (&ge;2-grade improvement from baseline in investigator&rsquo;s global assessment [IGA] and score of clear/almost clear), reduction from baseline in affected body surface area (BSA), and reduction in mean IGA &times; BSA. Safety was evaluated via treatment-emergent adverse events (TEAEs).
RESULTS


Of 418 participants, 60 and 358 self-identified as non-White and White, respectively; 115 of 418 participants self-identified as Hispanic/Latino. At week 8, a higher percentage of HP/TAZ-treated participants achieved treatment success vs vehicle (non-White, 34.4% vs 19.0%; White, 41.8% vs 8.7%; Hispanic/Latino, 39.3% vs 9.3%); rates for White and Hispanic/Latino participants were statistically significant. Compared with vehicle, HP/TAZ-treated participants in each subgroup experienced numerically greater reductions in affected BSA and IGA &times; BSA at week 8. The most common TEAEs were contact dermatitis, pruritus, nasopharyngitis, and application-site pain; discontinuations due to TEAEs were few.
CONCLUSIONS


HP/TAZ reduced disease severity in non-White, White, and Hispanic/Latino participants with psoriasis, with good tolerability and safety over 8 weeks of treatment. J Drugs Dermatol. 2021;20(7):735-744. doi:10.36849/JDD.6158.",2021,"Compared with vehicle, HP/TAZ-treated participants in each subgroup experienced numerically greater reductions in affected BSA and IGA &times; BSA at week 8.","['Adult participants', 'patients with skin of color', 'subgroups of non-White and White participants, including Hispanic/Latino participants', 'Patients With Skin of Color', 'Of 418 participants, 60 and 358 self-identified as non-White and White, respectively; 115 of 418 participants self-identified as Hispanic/Latino']","['HP/TAZ or vehicle lotion', 'Fixed-Combination Halobetasol Propionate and Tazarotene Lotion', 'HP/TAZ', 'tazarotene (0.045%) lotion (HP/TAZ', 'Fixed-combination halobetasol propionate']","['contact dermatitis, pruritus, nasopharyngitis, and application-site pain; discontinuations', 'disease severity', 'BSA and IGA &times; BSA', 'investigator&rsquo;s global assessment [IGA] and score of clear/almost clear), reduction from baseline in affected body surface area (BSA), and reduction in mean IGA &times; BSA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C4517540', 'cui_str': '115'}]","[{'cui': 'C0098735', 'cui_str': 'Halobetasol propionate'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0288792', 'cui_str': 'tazarotene'}, {'cui': 'C4517410', 'cui_str': '0.045'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0011616', 'cui_str': 'Contact dermatitis'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0521491', 'cui_str': 'Application site pain'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.395421,"Compared with vehicle, HP/TAZ-treated participants in each subgroup experienced numerically greater reductions in affected BSA and IGA &times; BSA at week 8.","[{'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Alexis', 'Affiliation': ''}, {'ForeName': 'Seemal R', 'Initials': 'SR', 'LastName': 'Desai', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.735']
808,34232000,A Randomized Study on PLLA Using Higher Dilution Volume and Immediate Use Following Reconstitution.,"BACKGROUND


The reconstitution volume of a PLLA-containing injectable device has gradually increased in clinical practice, often in combination with adding lidocaine to the solution.
OBJECTIVE


This study, SCRIPT (Sculptra Contemporary Reconstitution &amp; Injection Procedure Trial) evaluated PLLA for correction of nasolabial folds after changes in reconstitution and injection procedures. Primary endpoint for effectiveness was change from baseline of nasolabial folds, assessed by blinded evaluation using a validated wrinkle assessment scale (WAS), at week 48.
METHODS


Subjects were treated to optimal correction of nasolabial folds at a single treatment regimen consisting of &le;4 injection sessions, with PLLA reconstituted with 8 mL or 5 mL sterile water for injection (SWFI), randomized 2:1. The 8 mL product included an additional 1 mL 2%-lidocaine and was injected immediately following reconstitution. Assessments included wrinkle severity, aesthetic improvement and safety.
RESULTS


A total of 80 subjects were included in the study. Most subjects were female (95%), mean age was 51.5 years. Primary endpoint was met and subjects from both study groups demonstrated high WAS responder rates (&ge;1-grade improvement from baseline) at week 24 (&ge;75%) and week 48 (&ge;67%). Aesthetic improvement was high (&ge;86%) throughout the study. Adverse events related to study product or injection procedure were mostly mild and transient.
CONCLUSION


PLLA reconstituted with 8 mL SWFI demonstrated a comparable treatment effect to that of the reference group in reducing wrinkle severity of nasolabial folds. Safety was not compromised using a higher reconstitution volume including lidocaine, injected immediately after reconstitution. J Drugs Dermatol. 2021;20(7):&nbsp;760-766.. doi:10.36849/JDD.6034THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.",2021,"CONCLUSION


PLLA reconstituted with 8 mL SWFI demonstrated a comparable treatment effect to that of the reference group in reducing wrinkle severity of nasolabial folds.","['Subjects', 'A total of 80 subjects were included in the study', 'Most subjects were female (95%), mean age was 51.5 years']","['lidocaine', '2%-lidocaine', 'PLLA', 'PLLA reconstituted with 8 mL or 5 mL sterile water for injection (SWFI']","['nasolabial folds, assessed by blinded evaluation using a validated wrinkle assessment scale (WAS', 'high WAS responder rates', 'wrinkle severity of nasolabial folds', 'wrinkle severity, aesthetic improvement and safety', 'Aesthetic improvement']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1163679', 'cui_str': 'Water 1 g/mL solution for injection'}]","[{'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",80.0,0.0601704,"CONCLUSION


PLLA reconstituted with 8 mL SWFI demonstrated a comparable treatment effect to that of the reference group in reducing wrinkle severity of nasolabial folds.","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Palm', 'Affiliation': ''}, {'ForeName': 'Susaan', 'Initials': 'S', 'LastName': 'Weinkle', 'Affiliation': ''}, {'ForeName': 'Younghoon', 'Initials': 'Y', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Bredna', 'Initials': 'B', 'LastName': 'LaTowsky', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Prather', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.6034']
809,34238979,"Implications of Tamarkoz on stress, emotion, spirituality and heart rate.","Perceived stress among university students is a prevalent health issue directly correlated with poor academic performance, poor sleep quality, hopelessness, compromised physical and mental health, high risk of substance abuse, and suicidal ideation. Tamarkoz, a Sufi meditation, may reduce the impact of stressors to prevent illness among students. Tamarkoz is the art of self-knowledge through concentration and meditation. It is a method of concentration that can be applied to any task. The method is said to discipline the mind, body, and emotions to avoid unintended distractions. Therefore, it can be used in daily life activities, such as studying, eating, driving, de-stressing or in Sufism, seeking self-knowledge. This study was an 18-week quasi-experimental design with pre-intervention, post-intervention and follow-up assessments in the experimental group, a wait-list control, and a third group that utilized the campus health center's stress management resources. Participants, university students, had no prior exposure to Tamarkoz, and there were no statistically significant differences among groups on baseline measurements. Using a generalized linear mixed model, significant increases in positive emotions and daily spiritual experiences, and reductions in perceived stress and heart rate were found in the experimental group compared to the other two groups. Tamarkoz seems to show some advantages over the usual stress management resources offered by a student health center.Trial registration: ClinicalTrials.gov Protocol Registration Date: (03/04/2018); ClinicalTrials.gov ID: NCT03489148.",2021,"Participants, university students, had no prior exposure to Tamarkoz, and there were no statistically significant differences among groups on baseline measurements.",['university students'],"['Tamarkoz, a Sufi meditation', 'Tamarkoz']","['academic performance, poor sleep quality, hopelessness, compromised physical and mental health, high risk of substance abuse, and suicidal ideation', 'positive emotions and daily spiritual experiences', 'stress, emotion, spirituality and heart rate', 'perceived stress and heart rate']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0429674,"Participants, university students, had no prior exposure to Tamarkoz, and there were no statistically significant differences among groups on baseline measurements.","[{'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Bahadorani', 'Affiliation': 'Center for Nutrition, Healthy Lifestyle, and Disease Prevention, Loma Linda University|School of Public Health, 24951 North Circle Drive, Nichol Hall 1511, Loma Linda, CA, 92350, USA. Nasimb1@gmail.com.'}, {'ForeName': 'Jerry W', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Center for Nutrition, Healthy Lifestyle, and Disease Prevention, Loma Linda University|School of Public Health, 24951 North Circle Drive, Nichol Hall 1313, Loma Linda, CA, 92350, USA.'}, {'ForeName': 'Leslie R', 'Initials': 'LR', 'LastName': 'Martin', 'Affiliation': 'Department of Psychology, La Sierra University, 4500 Riverwalk Parkway, Riverside, CA, 92505, USA.'}]",Scientific reports,['10.1038/s41598-021-93470-8']
810,34238836,Using Newly Developed Software to Enhance the Efficiency of the Nursing Process in Patient Care: A Randomized Clinical Trial.,"The nursing process is a systematic decision-making method of problem-solving that increases the quality of patient care. Implementation of modern technology in nursing can reduce documentation time, make nursing care safer, and improve the quality of patient care. This study aimed to determine the effectiveness of applying newly developed nursing process software on the efficiency of the nursing process in patient care. In this randomized clinical trial, 80 nursing students were randomly allocated into intervention (n = 40) and control (n = 40) groups. The student in the intervention group used the software to care for patients for two semesters. Students in the control group used routine hospital protocol to care for their patients. Modified Brooking nursing process measuring scale was used to evaluate the effectiveness of software before and after the intervention. The results showed a statistically significant difference in the mean efficiency score of the nursing process in the two groups after the intervention (P < .001). Using nursing process software leads to increasing the efficiency of the nursing process in patient care. Thus, providing executive support and electronic resources with relevant training for nursing students can be beneficial in students' education and be a practical application of the nursing process in caring for patients.",2021,The results showed a statistically significant difference in the mean efficiency score of the nursing process in the two groups after the intervention (P < .001).,"['80 nursing students', 'Patient Care', 'patient care']",[],['mean efficiency score of the nursing process'],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028692', 'cui_str': 'Process, Nursing'}]",80.0,0.0147079,The results showed a statistically significant difference in the mean efficiency score of the nursing process in the two groups after the intervention (P < .001).,"[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Alsadat Hosseini', 'Affiliation': 'Author Affiliations: Community Based Psychiatric Care Research Center, Shiraz University of Medical Sciences, Shiraz (Dr Alsadat Hosseini); Medical Education Research Center, Health Management and Safety Promotion Research Institute, Tabriz University of Medical Sciences, Tabriz (Ms Parvan); Department of Medical-Surgical Nursing, Nursing and Midwifery School, Urmia University of Medical Sciences, Urmia (Dr Jasemi), Patient Safety Research Center, Clinical Research Institute, Nursing & Midwifery School, Urmia University of Medical Sciences, Urmia (Dr Parizad), and Department of Medical-Surgical Nursing, Nursing and Midwifery School (Ms Esmaeili Zabihi), Urmia University of Medical Sciences, Urmia; and Department of Medical-Surgical Nursing, Nursing and Midwifery School, Ilam University of Medical Sciences, Ilam (Dr Aazami), Iran.'}, {'ForeName': 'Kobra', 'Initials': 'K', 'LastName': 'Parvan', 'Affiliation': ''}, {'ForeName': 'Madineh', 'Initials': 'M', 'LastName': 'Jasemi', 'Affiliation': ''}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Parizad', 'Affiliation': ''}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Esmaili Zabihi', 'Affiliation': ''}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Aazami', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000772']
811,34237107,"Oxygen systems and quality of care for children with pneumonia, malaria and diarrhoea: Analysis of a stepped-wedge trial in Nigeria.","OBJECTIVES


To evaluate the effect of improved hospital oxygen systems on quality of care (QOC) for children with severe pneumonia, severe malaria, and diarrhoea with severe dehydration.
DESIGN


Stepped-wedge cluster randomised trial (unblinded), randomised at hospital-level.
SETTING


12 hospitals in south-west Nigeria.
PARTICIPANTS


7,141 children (aged 28 days to 14 years) admitted with severe pneumonia, severe malaria or diarrhoea with severe dehydration between January 2014 and October 2017.
INTERVENTIONS


Phase 1 (pulse oximetry) introduced pulse oximetry for all admitted children. Phase 2 (full oxygen system) (i) standardised oxygen equipment package, (ii) clinical education and support, (iii) technical training and support, and (iv) infrastructure and systems support.
OUTCOME MEASURES


We used quantitative QOC scores evaluating assessment, diagnosis, treatment, and monitoring practices against World Health Organization and Nigerian standards. We evaluated mean differences in QOC scores between study periods (baseline, oximetry, full oxygen system), using mixed-effects linear regression.
RESULTS


7,141 eligible participants; 6,893 (96.5%) had adequate data for analysis. Mean paediatric QOC score (maximum 6) increased from 1.64 to 3.00 (adjusted mean difference 1.39; 95% CI 1.08-1.69, p<0.001) for severe pneumonia and 2.81 to 4.04 (aMD 1.53; 95% CI 1.23-1.83, p<0.001) for severe malaria, comparing the full intervention to baseline, but did not change for diarrhoea with severe dehydration (aMD -0.12; 95% CI -0.46-0.23, p = 0.501). After excluding practices directly related to pulse oximetry and oxygen, we found aMD 0.23 for severe pneumonia (95% CI -0.02-0.48, p = 0.072) and 0.65 for severe malaria (95% CI 0.41-0.89, p<0.001) comparing full intervention to baseline. Sub-analysis showed some improvements (and no deterioration) in care processes not directly related to oxygen or pulse oximetry.
CONCLUSION


Improvements in hospital oxygen systems were associated with higher QOC scores, attributable to better use of pulse oximetry and oxygen as well as broader improvements in clinical care, with no negative distortions in care practices.
TRIAL REGISTRATION


ACTRN12617000341325.",2021,"Sub-analysis showed some improvements (and no deterioration) in care processes not directly related to oxygen or pulse oximetry.
","['12 hospitals in south-west Nigeria', '7,141 children (aged 28 days to 14 years) admitted with severe pneumonia, severe malaria or diarrhoea with severe dehydration between January 2014 and October 2017', '7,141 eligible participants; 6,893 (96.5%) had adequate data for analysis', 'children with pneumonia, malaria and diarrhoea', 'children with severe pneumonia, severe malaria, and diarrhoea with severe dehydration']","['Phase 2 (full oxygen system', 'hospital oxygen systems', 'Phase 1 (pulse oximetry) introduced pulse oximetry', 'i) standardised oxygen equipment package, (ii) clinical education and support, (iii) technical training and support, and (iv) infrastructure and systems support']","['Mean paediatric QOC score', 'quality of care (QOC', 'severe malaria', 'Oxygen systems and quality of care', 'pulse oximetry and oxygen', 'severe pneumonia', 'QOC scores', 'diarrhoea with severe dehydration']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2747816', 'cui_str': 'Complicated malaria'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3472181', 'cui_str': 'Severe dehydration'}, {'cui': 'C4517907', 'cui_str': '96.5'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]","[{'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0462865', 'cui_str': 'Oxygen equipment'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2747816', 'cui_str': 'Complicated malaria'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3472181', 'cui_str': 'Severe dehydration'}]",7141.0,0.222015,"Sub-analysis showed some improvements (and no deterioration) in care processes not directly related to oxygen or pulse oximetry.
","[{'ForeName': 'Hamish R', 'Initials': 'HR', 'LastName': 'Graham', 'Affiliation': ""Centre for International Child Health, The Royal Children's Hospital, MCRI, University of Melbourne, Parkville, Australia.""}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Maher', 'Affiliation': ""Department of Paediatrics, Royal Children's Hospital, University of Melbourne, Parkville, Australia.""}, {'ForeName': 'Ayobami A', 'Initials': 'AA', 'LastName': 'Bakare', 'Affiliation': 'Department of Paediatrics, University College Hospital, Ibadan, Nigeria.'}, {'ForeName': 'Cattram D', 'Initials': 'CD', 'LastName': 'Nguyen', 'Affiliation': ""Department of Paediatrics, Royal Children's Hospital, University of Melbourne, Parkville, Australia.""}, {'ForeName': 'Adejumoke I', 'Initials': 'AI', 'LastName': 'Ayede', 'Affiliation': 'Department of Paediatrics, University College Hospital, Ibadan, Nigeria.'}, {'ForeName': 'Oladapo B', 'Initials': 'OB', 'LastName': 'Oyewole', 'Affiliation': 'Department of Paediatrics, University College Hospital, Ibadan, Nigeria.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': ""Centre for International Child Health, The Royal Children's Hospital, MCRI, University of Melbourne, Parkville, Australia.""}, {'ForeName': 'Rasa', 'Initials': 'R', 'LastName': 'Izadnegahdar', 'Affiliation': 'Bill and Melinda Gates Foundation, Seattle, Washington, United States of America.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Duke', 'Affiliation': ""Centre for International Child Health, The Royal Children's Hospital, MCRI, University of Melbourne, Parkville, Australia.""}, {'ForeName': 'Adegoke G', 'Initials': 'AG', 'LastName': 'Falade', 'Affiliation': 'Department of Paediatrics, University College Hospital, Ibadan, Nigeria.'}]",PloS one,['10.1371/journal.pone.0254229']
812,34243187,Comparing flipped classroom and conventional live demonstration for teaching orthodontic wire-bending skill.,"Flipped classroom may overcome weaknesses of live demonstration in teaching orthodontic wire-bending. This study aims to compare the effectiveness between flipped classroom and live demonstration in transferring skills for fabricating Adams clasp. Forty third-year undergraduate dental students were assigned to two groups. The students in group LD (n = 20) attended a live demonstration while students in group FC (n = 20) attended a flipped classroom. Both groups were taught on skills to fabricate Adams clasp in a standardised way. Each student from both groups were asked to submit an Adams clasp for a blinded quality assessment by two trained and calibrated assessors using a 18-item rubric, followed by validated students' satisfaction questionnaires to evaluate their perceived satisfaction on the teaching method received. A crossover study was then conducted three weeks later where LD attended a flipped classroom while FC attended a live demonstration. Students' satisfaction questionnaires were again collected from each student for blinded analysis. Mean scores for the quality of Adams clasp were 9.775 and 9.125 for LD and FC, respectively. No significant difference was detected between the two groups. Statistically significant association was found for one statement on the questionnaire, ""I found the classroom arrangements conducive for the wire-bending activity"" (p = 0.010). No significant differences were found between the two groups for other statements (p > 0.05). In conclusion, within the limitations of the study, flipped classroom is equally effective as conventional live demonstration in transferring orthodontic wire-bending skills for fabrication of Adams clasp. However, students perceived the classroom arrangements during the flipped classroom significantly more conducive for teaching orthodontic wire-bending.",2021,No significant differences were found between the two groups for other statements (p > 0.05).,"['Forty third-year undergraduate dental students', 'fabricating Adams clasp', 'students in group LD (n = 20) attended a live demonstration while students in group FC (n = 20) attended a flipped classroom']",['flipped classroom and live demonstration'],"[""Students' satisfaction questionnaires"", 'Mean scores']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C1529905', 'cui_str': '(123I)ADAM'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}]","[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0764749,No significant differences were found between the two groups for other statements (p > 0.05).,"[{'ForeName': 'May Nak', 'Initials': 'MN', 'LastName': 'Lau', 'Affiliation': 'Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Kamarudin', 'Affiliation': 'Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nor Nadia', 'Initials': 'NN', 'LastName': 'Zakaria', 'Affiliation': 'Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Saritha', 'Initials': 'S', 'LastName': 'Sivarajan', 'Affiliation': 'Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Norhidayah Nor Zahidah', 'Initials': 'NNZ', 'LastName': 'Mohd Tahir', 'Affiliation': 'Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Aufa Dahlia', 'Initials': 'AD', 'LastName': 'Bahar', 'Affiliation': 'Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Naimie', 'Affiliation': ""University Malaya Dental Education Enhancement and Development Unit (UMDEED), Dean's Office, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Siti Adibah', 'Initials': 'SA', 'LastName': 'Othman', 'Affiliation': 'Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Wan N', 'Initials': 'WN', 'LastName': 'Wan Hassan', 'Affiliation': 'Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}]",PloS one,['10.1371/journal.pone.0254478']
813,34247932,A multicenter open-label extension study of intrathecal heparan-N-sulfatase in patients with Sanfilippo syndrome type A.,"Sanfilippo syndrome type A (mucopolysaccharidosis type IIIA) is a rare autosomal recessive lysosomal disorder characterized by deficient heparan-N-sulfatase (HNS) activity, and subsequent accumulation of heparan sulfate, especially in the central nervous system. The disease is associated with progressive neurodegeneration in early childhood. For this open-label extension study of a phase 2b clinical trial, we report on safety and cognitive decline in patients receiving intrathecal (IT) administration of recombinant human HNS (rhHNS). Of 21 patients who completed the phase 2b study, 17 continued in the open-label extension. Patients receiving rhHNS IT 45 mg continued to receive the same treatment regimen (i.e., every 2 weeks or every 4 weeks) throughout the extension. Patients receiving no treatment in the phase 2b study were re-randomized to the treatment groups. Neurocognition was assessed using the Bayley Scales of Infant and Toddler Development®, Third Edition (BSID-III). Adverse events were recorded over the duration of the treatment period. Cognitive decline was observed in most patients in both treatment groups; however, improvements in BSID-III development quotient score were observed for two patients, in receptive and expressive communication scores for three patients each, in fine motor skills for one patient, and in gross motor skills for six patients. Treatment-emergent adverse events that occurred with rhHNS IT were mostly mild, none led to study discontinuation, and there were no deaths. The extension study was terminated early as the primary endpoints of the phase 2b study were not met, and no statistical analyses were carried out. Although cognitive decline was apparent in most patients, improvements were observed in a small group of patients. Greater declines were observed in patients at the higher end of the age range, suggesting earlier intervention may increase the possibility of a response to treatment. rhHNS IT treatment remained generally well tolerated up to 96 weeks.",2021,"Cognitive decline was observed in most patients in both treatment groups; however, improvements in BSID-III development quotient score were observed for two patients, in receptive and expressive communication scores for three patients each, in fine motor skills for one patient, and in gross motor skills for six patients.","['patients receiving intrathecal (IT) administration of recombinant human HNS (rhHNS', '21 patients who completed the phase 2b study, 17 continued in the open-label extension', 'patients with Sanfilippo syndrome type A', 'Patients receiving no treatment in the phase 2b study were re-randomized to the treatment groups']",['intrathecal heparan-N-sulfatase'],"['Adverse events', 'Bayley Scales of Infant and Toddler Development®, Third Edition (BSID-III', 'safety and cognitive decline', 'BSID-III development quotient score', 'Cognitive decline', 'cognitive decline']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0062504', 'cui_str': 'Heparan N-sulfatase'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086647', 'cui_str': 'Mucopolysaccharidosis, MPS-III-A'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0062504', 'cui_str': 'Heparan N-sulfatase'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0378397,"Cognitive decline was observed in most patients in both treatment groups; however, improvements in BSID-III development quotient score were observed for two patients, in receptive and expressive communication scores for three patients each, in fine motor skills for one patient, and in gross motor skills for six patients.","[{'ForeName': 'Frits A', 'Initials': 'FA', 'LastName': 'Wijburg', 'Affiliation': 'Academic Medical Center, Amsterdam, the Netherlands. Electronic address: f.a.wijburg@amc.uva.nl.'}, {'ForeName': 'Chester B', 'Initials': 'CB', 'LastName': 'Whitley', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA. Electronic address: whitley@umn.edu.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Muenzer', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA. Electronic address: muenzer@med.unc.edu.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Gasperini', 'Affiliation': 'Fondazione MBBM, San Gerardo Hospital, Monza, Italy. Electronic address: s.gasperini@hsgerardo.org.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Del Toro', 'Affiliation': ""Hospital Vall D'Hebron, Barcelona, Spain. Electronic address: mdeltoro@vhebron.net.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Muschol', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Pediatrics, Hamburg, Germany. Electronic address: muschol@uke.de.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Cleary', 'Affiliation': 'Great Ormond Street Hospital, London, UK. Electronic address: Maureen.Cleary@gosh.nhs.uk.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sevin', 'Affiliation': 'Unit, GHU Paris-Sud - Hôpital de Bicêtre, Le Kremlin Bicêtre, Paris, France. Electronic address: caroline.sevin@inserm.fr.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Shapiro', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA. Electronic address: shapi004@umn.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Alexanderian', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Lexington, MA, USA. Electronic address: david.alexanderian@takeda.com.'}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2021.07.001']
814,34246485,Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of Tegoprazan.,"PURPOSE


Tegoprazan is a potassium-competitive acid blocker (P-CAB) that is designed to treat acid-related diseases through a fundamentally different mechanism than that of proton pump inhibitors (PPIs). Because PPIs inhibit only activated parietal cell H + /K +  adenosine triphosphatase, stimulation of parietal cells by a meal is necessary for optimal results. In contrast, P-CABs can inactivate proton pumps without acid activation and bind to both activated and inactivated adenosine triphosphatase. This study evaluates the effect of food consumption on the pharmacokinetic and pharmacodynamic properties of tegoprazan after a single oral dose in healthy men.
METHODS


In this open-label, 2-period crossover study, 24 healthy men were randomized to 1 of 2 treatment sequence groups: administration of tegoprazan under the fasting condition and administration of tegoprazan under the fed condition. The dosing periods of both sequence groups were separated by a washout period of 7 days. At each dosing period, the participants received a single dose of 200 mg of tegoprazan followed by pharmacokinetic and pharmacodynamic analysis.
FINDINGS


After the oral administration of 200 mg tegoprazan, the C max  was decreased and delayed under the fed condition compared with that of the fasting condition. However, no significant differences were observed in the AUC and the time of gastric acid suppression (inhibition of integrated acidity) during 24 hours.
IMPLICATIONS


The pharmacokinetic and pharmacodynamic properties of tegoprazan are independent of food effect; thus, tegoprazan could be administered regardless of the timing of food consumption in patients. ClinicalTrials.gov identifier: NCT01830309.",2021,"However, no significant differences were observed in the AUC and the time of gastric acid suppression (inhibition of integrated acidity) during 24 hours.
","['24 healthy men', 'patients', 'healthy men']","['tegoprazan under the fasting condition and administration of tegoprazan under the fed condition', 'tegoprazan', 'food consumption', 'Tegoprazan']","['C max', 'AUC and the time of gastric acid suppression (inhibition of integrated acidity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4726822', 'cui_str': 'tegoprazan'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017119', 'cui_str': 'Gastric acid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]",24.0,0.0433198,"However, no significant differences were observed in the AUC and the time of gastric acid suppression (inhibition of integrated acidity) during 24 hours.
","[{'ForeName': 'Sungpil', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': ""Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital, Seoul, Korea; Pharmacometrics Institute for Practical Education and Training, Department of Pharmacology, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Hee Youn', 'Initials': 'HY', 'LastName': 'Choi', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Yo Han', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Nam', 'Affiliation': 'Clinical Development Division, HK inno.N Corp, Seoul, Korea.'}, {'ForeName': 'Bongtae', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Clinical Development Division, HK inno.N Corp, Seoul, Korea.'}, {'ForeName': 'Geun Seog', 'Initials': 'GS', 'LastName': 'Song', 'Affiliation': 'Clinical Development Division, HK inno.N Corp, Seoul, Korea.'}, {'ForeName': 'Hyeong-Seok', 'Initials': 'HS', 'LastName': 'Lim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Kyun-Seop', 'Initials': 'KS', 'LastName': 'Bae', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan, Seoul, Korea. Electronic address: ksbae@amc.seoul.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2021.06.007']
815,34251484,Results of patients with neovascular age-related macular degeneration managed by a treat-extend-stop protocol without recurrence.,"PURPOSE


To assess vision, injection quantity, initial lesion size, and final anatomic status in patients with nAMD completing the treat-extend-stop (TES) protocol.
METHODS


Patients with nAMD received ≥ 3 monthly anti-VEGF injections followed by 1-2 week injection interval extensions, with intra/subretinal fluid resolution on SD-OCT, to 12 weeks. With quiescent disease, and 2 quarterly injections, patients were monitored alone beginning at 4 weeks extending by 1-2 week intervals until quarterly monitoring.
RESULTS


Eighty-eight of 143 eyes with nAMD completed the TES protocol without disease recurrence. Sixteen (18.2%) developed sub-foveal geographic atrophy (GA), 25 (28.4%) developed fibrovascular scarring (FV) and 47 (53.4%) developed regressed choroidal neovascularization (rCNV) with 16.9 ± 13.3 average injections between the 3 groups which was not statistically significant. Average treatment time was 30.3 ± 26.1 months and subsequent follow-up was 23.2 ± 19.8 months. Average lesion size for FV was 18.77 ± 10.8mm 2  vs. GA at 12.00 ± 9.99mm 2  vs. regressed CNV at 7.12 ± 6.5mm 2  (p < 0.05). Pre, post, and final vision for GA was 39.6 letters (20/160) vs. 32.7 letters (20/200 + 2, p = 0.4725) vs. 25.0 letters (20/320, p = 0.0865); FV was 22.4 letters (20/400 + 2) vs. 11.6 letters (20/640, p = 0.0351) vs. 11.0 letters (20/640 + 1, p = 0.0226), and rCNV was 56.4 letters (20/80 + 1) vs. 69.5 letters (20/40, p < 0.001) vs. 67.3 letters (20/40-2, p = 0.0016). In the rCNV group, 17/46 eyes gained ≥ 3 lines and 30/46 eyes achieved ≥ 20/40 vision. Non-central GA expanded 0.226 ± 0.126 mm vs. 0.225 ± 0.098 mm during and after treatment completion over 24 months (p = 0.99).
CONCLUSIONS


Central GA or FV portends worse visual outcomes vs. rCNV after cessation of therapy. Anti-VEGF therapy may not affect the rate of GA expansion. Final anatomic character and location are key determinants of final vision.",2021,"Non-central GA expanded 0.226 ± 0.126 mm vs. 0.225 ± 0.098 mm during and after treatment completion over 24 months (p = 0.99).
","['patients with nAMD completing the treat-extend-stop (TES) protocol', 'Eighty-eight of 143 eyes with nAMD completed the TES protocol without disease recurrence', 'Patients with nAMD received', 'patients with neovascular age-related macular degeneration managed by a treat-extend-stop protocol without recurrence']","['rCNV', '≥\u20093 monthly anti-VEGF injections', 'Anti-VEGF therapy']","['rate of GA expansion', 'vision, injection quantity, initial lesion size, and final anatomic status', 'fibrovascular scarring (FV', 'sub-foveal geographic atrophy (GA', 'Average lesion size for FV', 'regressed choroidal neovascularization (rCNV', 'final vision for GA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4727874', 'cui_str': 'Anti-VEGF therapy'}]","[{'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0392759', 'cui_str': 'Fibrovascular'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}]",,0.202752,"Non-central GA expanded 0.226 ± 0.126 mm vs. 0.225 ± 0.098 mm during and after treatment completion over 24 months (p = 0.99).
","[{'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Adrean', 'Affiliation': 'Retina Consultants of Orange County, 301 W. Bastanchury Ave #285, Fullerton, CA, 92835, USA. seadrean@yahoo.com.'}, {'ForeName': 'Siyang', 'Initials': 'S', 'LastName': 'Chaili', 'Affiliation': 'Retina Consultants of Orange County, 301 W. Bastanchury Ave #285, Fullerton, CA, 92835, USA.'}, {'ForeName': 'Ash', 'Initials': 'A', 'LastName': 'Pirouz', 'Affiliation': 'Retina Consultants of Orange County, 301 W. Bastanchury Ave #285, Fullerton, CA, 92835, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Grant', 'Affiliation': 'Retina Consultants of Orange County, 301 W. Bastanchury Ave #285, Fullerton, CA, 92835, USA.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-021-05283-0']
816,34263930,Expected individual benefit of prophylactic platelet transfusions in hemato-oncology patients based on bleeding risks.,"BACKGROUND


Prophylactic platelet transfusions prevent bleeding in hemato-oncology patients, but it is unclear how any benefit varies between patients. Our aim was to assess if patients with different baseline risks for bleeding benefit differently from a prophylactic platelet transfusion strategy.
STUDY DESIGN AND METHODS


Using the data from the randomized controlled TOPPS trial (Trial of Platelet Prophylaxis), we developed a prediction model for World Health Organization grades 2, 3, and 4 bleeding risk (defined as at least one bleeding episode in a 30 days period) and grouped patients in four risk-quartiles based on this predicted baseline risk. Predictors in the model were baseline platelet count, age, diagnosis, disease modifying treatment, disease status, previous stem cell transplantation, and the randomization arm.
RESULTS


The model had a c-statistic of 0.58 (95% confidence interval [CI] 0.54-0.64). There was little variation in predicted risks (quartiles 46%, 47%, and 51%), but prophylactic platelet transfusions gave a risk reduction in all risk quartiles. The absolute risk difference (ARD) was 3.4% (CI -12.2 to 18.9) in the lowest risk quartile (quartile 1), 7.4% (95% CI -8.4 to 23.3) in quartile 2, 6.8% (95% CI -9.1 to 22.9) in quartile 3, and 12.8% (CI -3.1 to 28.7) in the highest risk quartile (quartile 4).
CONCLUSION


In our study, generally accepted bleeding risk predictors had limited predictive power (expressed by the low c-statistic), and, given the wide confidence intervals of predicted ARD, could not aid in identifying subgroups of patients who might benefit more (or less) from prophylactic platelet transfusion.",2021,"The absolute risk difference (ARD) was 3.4% (CI -12.2 to 18.9) in the lowest risk quartile (quartile 1), 7.4% (95% CI -8.4 to 23.3) in quartile 2, 6.8% (95% CI -9.1 to 22.9) in quartile 3, and 12.8% (CI -3.1 to 28.7) in the highest risk quartile (quartile 4).
","['hemato-oncology patients', 'patients with different baseline risks for bleeding benefit differently from a prophylactic platelet transfusion strategy']",['Platelet Prophylaxis'],"['bleeding risks', 'absolute risk difference (ARD']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0086818', 'cui_str': 'Platelet transfusion'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",,0.332568,"The absolute risk difference (ARD) was 3.4% (CI -12.2 to 18.9) in the lowest risk quartile (quartile 1), 7.4% (95% CI -8.4 to 23.3) in quartile 2, 6.8% (95% CI -9.1 to 22.9) in quartile 3, and 12.8% (CI -3.1 to 28.7) in the highest risk quartile (quartile 4).
","[{'ForeName': 'Loes L', 'Initials': 'LL', 'LastName': 'Cornelissen', 'Affiliation': 'Jon J van Rood Center for Clinical Transfusion Research, Sanquin/LUMC, Leiden, The Netherlands.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Caram-Deelder', 'Affiliation': 'Jon J van Rood Center for Clinical Transfusion Research, Sanquin/LUMC, Leiden, The Netherlands.'}, {'ForeName': 'Susanna F', 'Initials': 'SF', 'LastName': 'Fustolo-Gunnink', 'Affiliation': 'Jon J van Rood Center for Clinical Transfusion Research, Sanquin/LUMC, Leiden, The Netherlands.'}, {'ForeName': 'Rolf H H', 'Initials': 'RHH', 'LastName': 'Groenwold', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Stanworth', 'Affiliation': 'Transfusion Medicine, NHS Blood and Transplant (NHSBT), Oxford, UK.'}, {'ForeName': 'Jaap Jan', 'Initials': 'JJ', 'LastName': 'Zwaginga', 'Affiliation': 'Jon J van Rood Center for Clinical Transfusion Research, Sanquin/LUMC, Leiden, The Netherlands.'}, {'ForeName': 'Johanna G', 'Initials': 'JG', 'LastName': 'van der Bom', 'Affiliation': 'Jon J van Rood Center for Clinical Transfusion Research, Sanquin/LUMC, Leiden, The Netherlands.'}]",Transfusion,['10.1111/trf.16587']
817,34267301,Comparison between the trapezius and adductor pollicis muscles as an acceleromyography monitoring site for moderate neuromuscular blockade during lumbar surgery.,"Acceleromyography at the adductor pollicis located in a distal part of the body may not reflect the degree of neuromuscular blockade (NMB) at the proximally located muscles manipulated during lumbar surgery. We investigated the usefulness and characteristics of acceleromyographic monitoring at the trapezius for providing moderate NMB during lumbar surgery. Fifty patients were randomized to maintain a train-of-four count 1-3 using acceleromyography at the adductor pollicis (group A; n = 25) or the trapezius (group T; n = 25). Total rocuronium dose administered intraoperatively [mean ± SD, 106.4 ± 31.3 vs. 74.1 ± 17.6 mg; P < 0.001] and surgical satisfaction (median [IQR], 7 [5-8] vs. 5 [4-5]; P < 0.001) were significantly higher in group T than group A. Lumbar retractor pressure (88.9 ± 12.0 vs. 98.0 ± 7.8 mmHg; P = 0.003) and lumbar muscle tone in group T were significantly lower than group A. Time to maximum block with an intubating dose was significantly shorter in group T than group A (44 [37-54] vs. 60 [55-65] sec; P < 0.001). Other outcomes were comparable. Acceleromyography at the trapezius muscle during lumbar surgery required a higher rocuronium dose for moderate NMB than the adductor pollicis muscle, thereby the consequent deeper NMB provided better surgical conditions. Trapezius as proximal muscle may better reflect surgical conditions of spine muscle.",2021,"Acceleromyography at the trapezius muscle during lumbar surgery required a higher rocuronium dose for moderate NMB than the adductor pollicis muscle, thereby the consequent deeper NMB provided better surgical conditions.","['moderate neuromuscular blockade during lumbar surgery', 'Fifty patients']","['acceleromyography at the adductor pollicis (group A; n\u2009=\u200925) or the trapezius', 'Total rocuronium', 'Acceleromyography']","['surgical satisfaction', 'Lumbar retractor pressure', 'lumbar muscle tone']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3805242', 'cui_str': 'Acceleromyography'}, {'cui': 'C0224288', 'cui_str': 'Adductor pollicis muscle structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}]",50.0,0.0966922,"Acceleromyography at the trapezius muscle during lumbar surgery required a higher rocuronium dose for moderate NMB than the adductor pollicis muscle, thereby the consequent deeper NMB provided better surgical conditions.","[{'ForeName': 'Seok Kyeong', 'Initials': 'SK', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sangwoo', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Byung Gun', 'Initials': 'BG', 'LastName': 'Lim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea. bglim9205@korea.ac.kr.'}, {'ForeName': 'Young Sung', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Heezoo', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Myoung Hoon', 'Initials': 'MH', 'LastName': 'Kong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}]",Scientific reports,['10.1038/s41598-021-94062-2']
818,34269848,"A randomized, single-dose, pharmacokinetic equivalence study comparing MB02 (proposed biosimilar) and reference bevacizumab in healthy Japanese male volunteers.","PURPOSE


MB02 is a biosimilar to bevacizumab that has demonstrated similar physicochemical and functional properties in in vitro studies to the reference bevacizumab (Avastin ® ). This study aims to assess the pharmacokinetic (PK) similarity of MB02 to the reference bevacizumab in Japanese population.
METHODS


This double-blind, randomized, parallel-group, single-dose PK study, was performed in healthy Japanese male volunteers. Subjects were equally randomized (1:1) to receive a single (3 mg/kg) IV dose of MB02 or reference bevacizumab. PK assessments were done up to 70 days post-dose. Non-compartmental parameters were calculated. PK similarity was determined using predefined equivalence range (0.80-1.25) for the area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC 0-∞ ). Immunogenicity samples were taken pre-dose and up to day 70. Safety was assessed throughout the study.
RESULTS


In total, 48 subjects (24 in each treatment group) were dosed. Consequently to the observed similar PK profile, the 90% confidence interval for the geometric means ratio for the primary PK endpoint, AUC 0-∞ , was within the predefined equivalence range (0.981-1.11). Forty-seven treatment-emergent adverse events (TEAEs) were reported in 20 subjects (41.7%) with comparable incidence among MB02 and reference bevacizumab groups (22 and 25, respectively), none of them was severe or serious. Anti-drug antibodies incidence was low and similar between treatment groups.
CONCLUSIONS


Pharmacokinetic similarity of MB02 to reference bevacizumab was evidenced in Japanese healthy subjects, with comparable safety and immunogenicity profile between treatments. This study supports the biosimilarity of MB02 to reference bevacizumab in Japanese population. ClinicalTrials.gov identifier: NCT04238650.",2021,"Forty-seven treatment-emergent adverse events (TEAEs) were reported in 20 subjects (41.7%) with comparable incidence among MB02 and reference bevacizumab groups (22 and 25, respectively), none of them was severe or serious.","['healthy Japanese male volunteers', 'Japanese population', 'Japanese healthy subjects', '48 subjects (24 in each treatment group) were dosed']","['MB02 or reference bevacizumab', 'MB02 (proposed biosimilar) and reference bevacizumab', 'bevacizumab (Avastin ® ', 'bevacizumab']","['PK similarity', 'Safety', 'Anti-drug antibodies incidence', 'severe or serious']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",48.0,0.116839,"Forty-seven treatment-emergent adverse events (TEAEs) were reported in 20 subjects (41.7%) with comparable incidence among MB02 and reference bevacizumab groups (22 and 25, respectively), none of them was severe or serious.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'Clinical Research Unit, Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Karasuyama', 'Affiliation': 'Syneos Health Clinical K.K., Tokyo, Japan.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'González', 'Affiliation': 'Medical Department, mAbxience Research S.L., Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Del Campo García', 'Affiliation': 'Medical Department, mAbxience Research S.L., Madrid, Spain. ana.delcampo@mabxience.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-021-04324-z']
819,34269480,A distance-based living donor kidney education program for Black wait-list candidates: A feasibility randomized trial.,"Addressing racial disparities in living donor kidney transplants (LDKT) among Black patients warrants innovative programs to improve living donation rates. The Living Organ Video Educated Donors (LOVED) program is a 2-arm, culturally-tailored, distance-based, randomized controlled feasibility trial. The group-based, 8-week program used peer-navigator led video chat sessions and web-app video education for Black kidney waitlisted patients from United States southeastern state. Primary feasibility results for LOVED (n = 24) and usual care (n = 24) arms included LOVED program tolerability (i.e., 95.8% retention), program fidelity (i.e., 78.9% video education adherence and 72.1% video chat adherence). LDKT attitudinal and knowledge results favored the LOVED group where a statistically significant effect was reported over 6-months for willingness to approach strangers (estimate ± SE: -1.0 ± .55, F(1, 45.3) = 7.5, P = .009) and self-efficacy to advocate for a LDKT -.81 ± .31, F(1, 45.9) = 15.2, P < .001. Estimates were improved but not statistically significant for willingness to approach family and friends, LDKT knowledge and concerns for living donors (all P's > .088). Secondary measures at 6 months showed an increase in calls for LOVED compared to usual care (P = .008) though no differences were found for transplant center evaluations or LDKTs. Findings imply that LOVED increased screening calls and attitudes to approach potential donors but feasibility outcomes found program materials require modification to increase adherence.",2021,"Estimates were improved but not statistically significant for willingness to approach family and friends, LDKT knowledge and concerns for living donors (all p's >0.088).","['n=24) and usual care (n=24) arms included', 'living donor kidney transplants (LDKT) among Black patients', 'Black wait-list candidates', 'Black kidney waitlisted patients from a United States southeastern state']","['LOVED', 'distance-based living donor kidney education program', '8-week program used peer-navigator led video chat sessions and web-app video education']","['self-efficacy', 'LOVED program tolerability', 'calls for LOVED', 'willingness to approach family and friends, LDKT knowledge and concerns for living donors', 'program fidelity']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.00886961,"Estimates were improved but not statistically significant for willingness to approach family and friends, LDKT knowledge and concerns for living donors (all p's >0.088).","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Sieverdes', 'Affiliation': 'Department of Health and Human Performance, College of Charleston, Charleston, South Carolina, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Lynne S', 'Initials': 'LS', 'LastName': 'Nemeth', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Prabhakar K', 'Initials': 'PK', 'LastName': 'Baliga', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Treiber', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}]",Clinical transplantation,['10.1111/ctr.14426']
820,34268888,"Clinical evaluation of large volume subcutaneous injection tissue effects, pain, and acceptability in healthy adults.","Determining feasibility and tolerability of large volume viscous subcutaneous injection may enable optimized, intuitive delivery system design. A translational early feasibility clinical study examined large volume subcutaneous injection viability, tolerability, acceptability, tissue effects and depot location for ~1, 8, and 20 cP injections at volumes up to 10 ml in the abdomen and 5 ml in the thigh in 32 healthy adult subjects. A commercial syringe pump system delivered 192 randomized, constant rate (20 µl/s) injections (6/subject) with in-line injection pressure captured versus time. Deposition location was qualified via ultrasound. Tissue effects and pain tolerability were monitored through 2 hours post-injection with corresponding Likert acceptability questionnaires administered through 72 hours. All injection conditions were feasible and well-tolerated with ≥79.3% favorable subject responses for injection site appearance and sensation immediately post-injection, increasing to ≥96.8% at 24 hours. Mean subject pain measured via 100 mm visual analog scale increased at needle insertion (6.9 mm, SD 10.8), peaked during injection (26.9 mm, SD 21.7) and diminished within 10 minutes post-removal (1.9 mm, SD 4.2). Immediate injection site wheal (90.9%) and erythema (92.6%) formation was observed with progressive although incomplete resolution through 2 hours (44.6% and 11.4% remaining, respectively). Wheal resolution occurred more rapidly at lower viscosities. Most subjects (64.5%) had no preference between abdomen and thigh. Correlations between tissue effects, injection pressure and pain were weak (Pearson's rho ± 0-0.4). The large volume injections tested, 1-20 cP viscosities up to 10 ml in the abdomen and 5 ml in the thigh, are feasible with good subject acceptability and rapid resolution of tissue effects and pain.",2021,"Immediate injection site wheal (90.9%) and erythema (92.6%) formation was observed with progressive although incomplete resolution through 2 hours (44.6% and 11.4% remaining, respectively).","['Healthy Adults', '32 healthy adult subjects']",[],"['Wheal resolution', 'Tissue effects and pain tolerability', 'Pain, and Acceptability', 'tolerability, acceptability, tissue effects and depot location', 'erythema', 'tissue effects, injection pressure and pain', 'feasible and well-tolerated', 'Mean subject pain measured via 100mm visual analog scale']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0221232', 'cui_str': 'Weal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",32.0,0.0325038,"Immediate injection site wheal (90.9%) and erythema (92.6%) formation was observed with progressive although incomplete resolution through 2 hours (44.6% and 11.4% remaining, respectively).","[{'ForeName': 'Wendy D', 'Initials': 'WD', 'LastName': 'Woodley', 'Affiliation': 'BD Technologies & Innovation, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Didier R', 'Initials': 'DR', 'LastName': 'Morel', 'Affiliation': 'BD Medical- Pharmaceutical Systems, Le Pont de Claix, France.'}, {'ForeName': 'Diane E', 'Initials': 'DE', 'LastName': 'Sutter', 'Affiliation': 'BD Technologies & Innovation, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Pettis', 'Affiliation': 'BD Technologies & Innovation, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Natasha G', 'Initials': 'NG', 'LastName': 'Bolick', 'Affiliation': 'BD Technologies & Innovation, Research Triangle Park, North Carolina, USA.'}]",Clinical and translational science,['10.1111/cts.13109']
821,34272327,Effects of Dapagliflozin in Stage 4 Chronic Kidney Disease.,"BACKGROUND


In the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) randomized, placebo-controlled trial, the sodium-glucose cotransporter 2 inhibitor dapagliflozin significantly reduced risk of kidney failure and prolonged survival in patients with CKD with or without type 2 diabetes.
METHODS


Adults with eGFR of 25-75 ml/min per 1.73 m 2  and urinary albumin-to-creatinine ratio of 200-5000 mg/g had been randomized to receive dapagliflozin 10 mg/d or placebo. Here, we conducted a prespecified analysis of dapagliflozin's effects in patients with stage 4 CKD (eGFR,30 ml/min per 1.73 m 2 ) at baseline. The primary end point was a composite of time to ≥50% sustained decline in eGFR, ESKD, or kidney or cardiovascular death. Secondary end points were a kidney composite (same as the primary end point but without cardiovascular death), a composite of cardiovascular death or heart failure hospitalization, and all-cause death.
RESULTS


A total of 293 participants with stage 4 CKD received dapagliflozin and 331 received placebo. Patients with stage 4 CKD randomized to dapagliflozin experienced a 27% (95% confidence interval [95% CI]: -2 to 47%) reduction in the primary composite endpoint, and 29% (-2 to 51%), 17% (-53 to 55%), and 32% (-21 to 61%) reductions in the kidney, cardiovascular and mortality endpoints, respectively, relative to placebo. Interaction P-values were 0.22, 0.13, 0.63, and 0.95, respectively, comparing CKD stages 4 versus 2/3. The eGFR slope declined by 2.15 and 3.38 ml/min per 1.73 m 2  per year in the dapagliflozin and placebo groups, respectively ( P =0.005). Patients treated with dapagliflozin or placebo had similar rates of serious adverse events and adverse events of interest.
CONCLUSIONS


Among patients with stage 4 CKD and albuminuria, the effects of dapagliflozin were consistent with those observed in the DAPA-CKD trial overall, with no evidence of increased risks.",2021,"The eGFR slope declined by 2.15 and 3.38 mL/min per 1.73m2 per year in the dapagliflozin and placebo groups, respectively (P=0.005).","['Chronic Kidney Disease (DAPA-CKD) randomized', 'Stage 4 Chronic Kidney Disease', 'patients with stage 4 CKD (eGFR<30 mL/min per 1.73m2) at baseline', '293 participants received', 'CKD patients with or without type 2 diabetes']","['dapagliflozin 10 mg/day or placebo', 'dapagliflozin or placebo', 'placebo, dapagliflozin', 'Dapagliflozin', 'dapagliflozin', 'placebo']","['mortality endpoint', 'rates of serious adverse events and adverse events of interest', 'composite of time to ≥50% sustained decline in eGFR, end-stage kidney disease, or kidney or cardiovascular death', 'kidney failure and prolonged survival', 'eGFR slope', 'cardiovascular endpoint', 'kidney endpoint', 'kidney composite (same as the primary endpoint but without cardiovascular death), a composite of cardiovascular death or heart failure hospitalization, and all-cause death']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C2317473', 'cui_str': 'Chronic kidney disease stage 4'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1278655', 'cui_str': 'SAME AS'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",293.0,0.742961,"The eGFR slope declined by 2.15 and 3.38 mL/min per 1.73m2 per year in the dapagliflozin and placebo groups, respectively (P=0.005).","[{'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, California gchertow@stanford.edu.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jongs', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Toto', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Gorriz', 'Affiliation': 'Hospital Clinico Universitario de Valencia, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Fan Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefánsson', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Department of Renal Medicine, University College London, United Kingdom.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2021020167']
822,34216034,Targeted tDCS Mitigates Dual-Task Costs to Gait and Balance in Older Adults.,"OBJECTIVE


Among older adults, the ability to stand or walk while performing cognitive tasks (ie, dual-tasking) requires coordinated activation of several brain networks. In this multicenter, double-blinded, randomized, and sham-controlled study, we examined the effects of modulating the excitability of the left dorsolateral prefrontal cortex (L-DLPFC) and the primary sensorimotor cortex (SM1) on dual-task performance ""costs"" to standing and walking.
METHODS


Fifty-seven older adults without overt illness or disease completed 4 separate study visits during which they received 20 minutes of transcranial direct current stimulation (tDCS) optimized to facilitate the excitability of the L-DLPFC and SM1 simultaneously, or each region separately, or neither region (sham). Before and immediately after stimulation, participants completed a dual-task paradigm in which they were asked to stand and walk with and without concurrent performance of a serial-subtraction task.
RESULTS


tDCS simultaneously targeting the L-DLPFC and SM1, as well as tDCS targeting the L-DLPFC alone, mitigated dual-task costs to standing and walking to a greater extent than tDCS targeting SM1 alone or sham (p < 0.02). Blinding efficacy was excellent and participant subjective belief in the type of stimulation received (real or sham) did not contribute to the observed functional benefits of tDCS.
INTERPRETATION


These results demonstrate that in older adults, dual-task decrements may be amenable to change and implicate L-DPFC excitability as a modifiable component of the control system that enables dual-task standing and walking. tDCS may be used to improve resilience and the ability of older results to walk and stand under challenging conditions, potentially enhancing everyday functioning and reducing fall risks. ANN NEUROL 2021;90:428-439.",2021,"tDCS may be used to improve resilience and the ability of older results to walk and stand under challenging conditions, potentially enhancing everyday functioning.","['older adults', 'Fifty-seven older adults without overt illness or disease completed four separate study visits during which they received 20-minutes of']","['transcranial direct current stimulation (tDCS', 'tDCS']","[""dual-task performance 'costs' to standing and walking""]","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",57.0,0.128664,"tDCS may be used to improve resilience and the ability of older results to walk and stand under challenging conditions, potentially enhancing everyday functioning.","[{'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA.'}, {'ForeName': 'Wanting', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA.'}, {'ForeName': 'On-Yee', 'Initials': 'OY', 'LastName': 'Lo', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Gouskova', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Salvador', 'Affiliation': 'Neuroelectrics Corporation, Cambridge, MA.'}, {'ForeName': 'Racheli', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Cornejo Thumm', 'Affiliation': 'Center for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Brozgol', 'Affiliation': 'Center for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Neuroelectrics Corporation, Cambridge, MA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pascual-Leone', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': 'Center for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}]",Annals of neurology,['10.1002/ana.26156']
823,34214863,Self-disclosure is associated with adrenocortical attunement between new acquaintances.,"Adrenocortical attunement-similarity in hypothalamic-pituitary-adrenal (HPA) axis activity-has been well-documented in close relationships (e.g., between romantic partners, parents and children, and close friends). However, little is known about adrenocortical attunement during early relationship formation. In the current study, we examine dyadic adrenocortical attunement during a guided conversation in which two new acquaintances (N = 140 people, 70 dyads), who were university students or adults in the community, answered questions about themselves. Dyads were randomly assigned to answer questions designed to elicit dyad members to reveal a high or low amount of personal information (i.e., to self-disclose at high or low levels). We collected saliva samples (assayed for cortisol) before and after the conversation, and we coded behavioral self-disclosure-the extent to which people revealed their thoughts, feelings, and facts about themselves-during the conversation. As expected, dyads who were assigned to ask and answer high self-disclosure questions disclosed more than those assigned to ask and answer low self-disclosure questions. In addition, greater self-disclosure during the conversation was associated with greater similarity in cortisol change-that is, dyad members who revealed more about themselves experienced more similar cortisol changes in response to their conversation. This work reveals one social process through which adrenocortical attunement occurs during early relationship formation, and, in doing so, describes how our physiological functioning is linked to those around us-even people we have just met.",2021,"As expected, dyads who were assigned to ask and answer high self-disclosure questions disclosed more than those assigned to ask and answer low self-disclosure questions.","['dyadic adrenocortical attunement during a guided conversation in which two new acquaintances (N\xa0=\xa0140 people, 70 dyads), who were university students or adults in the community, answered questions about themselves']",[],['greater self-disclosure'],"[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0337609', 'cui_str': 'Acquaintance'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]",[],"[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0036596', 'cui_str': 'Self Disclosure'}]",140.0,0.04974,"As expected, dyads who were assigned to ask and answer high self-disclosure questions disclosed more than those assigned to ask and answer low self-disclosure questions.","[{'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Thorson', 'Affiliation': 'Dept. of Psychology, 3009 Broadway, Barnard College of Columbia University, New York, NY, USA. Electronic address: kthorson@barnard.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ketay', 'Affiliation': 'Department of Psychology, University of Hartford, West Hartford, CT, USA.'}, {'ForeName': 'Ashlin R K', 'Initials': 'ARK', 'LastName': 'Roy', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Welker', 'Affiliation': 'Department of Psychology, University of Massachusetts Boston, Boston, MA, USA.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105323']
824,34214823,The effects of presenting additional stimuli resembling the CS+ during extinction on extinction retention and generalisation to novel stimuli.,"Recent studies have shown that extinction training including the conditional stimulus (CS+) and stimuli similar to the CS + enhances extinction retention and generalisation to novel stimuli. The aim of the present study was to confirm that these effects are specific to presenting stimuli similar to the CS+ during extinction and not merely an effect of additional trials or additional stimuli unrelated to the CS+. In an experiment conducted in a single session on the same day, participants (134 adults; 70.7% female; 17-40 years of age, M = 20.04, SD = 4.36) completed a habituation phase followed by an acquisition phase using dog images presented with (CS+) and without (CS-) a dog growl paired with a scream unconditional stimulus (US). Participants were randomly allocated to four extinction conditions: Multiple exemplar extinction comprising the CSs and two novel dog images similar to the CS+; Standard extinction control matched for the number of CS+ and CS- presentations; Extended extinction control matched for the total number extinction trials, and Other stimuli extinction control comprising the CSs and two novel stimuli unrelated to the CS+. All participants completed an extinction test with the original CSs followed by a generalisation test with two novel dog images. Multiple, Standard and Other stimuli extinction groups exhibited larger skin conductance responses (SCRs) during extinction to the CSs compared to the Extended extinction group. SCRs to the additional dog images in the Multiple group were larger than SCRs to the additional CSs in the Extended group and the novel images in the Other stimuli group. There were no group differences in responses to the CSs during extinction test. Unlike the other groups, SCRs to the first presentation of the novel generalisation dogs did not differ from those to the last CS trials in extinction in the Multiple group. However, this group difference did not persist beyond the initial generalisation trial. Finally, the Multiple, Extended, and Other stimuli groups exhibited more negative CS evaluations after extinction, extinction test, and generalisation test than the Standard extinction group. The results suggest that extinction with the original CSs and additional stimuli resembling the CS + elevated physiological responses during extinction and reduced physiological responses to novel stimuli similar to the CSs. Further studies are needed including clinical samples and trial-by-trial evaluations of the stimuli presented.",2021,"Multiple, Standard and Other stimuli extinction groups exhibited larger skin conductance responses (SCRs) during extinction to the CSs compared to the Extended extinction group.","['participants (134 adults; 70.7% female; 17-40 years of age, M\xa0=\xa020.04, SD\xa0=\xa04.36) completed a']","['extinction conditions: Multiple exemplar extinction comprising the CSs and two novel dog images similar to the CS+; Standard extinction control matched for the number of CS+ and CS- presentations; Extended extinction control matched for the total number extinction trials, and Other stimuli extinction control comprising the CSs and two novel stimuli unrelated to the CS', 'habituation phase followed by an acquisition phase using dog images presented with (CS+) and without (CS-) a dog growl paired with a scream unconditional stimulus (US']","['larger skin conductance responses (SCRs', 'negative CS evaluations after extinction, extinction test, and generalisation test']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0521008', 'cui_str': 'Screaming'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",134.0,0.115861,"Multiple, Standard and Other stimuli extinction groups exhibited larger skin conductance responses (SCRs) during extinction to the CSs compared to the Extended extinction group.","[{'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Waters', 'Affiliation': 'School of Applied Psychology, Griffith University, Australia. Electronic address: a.waters@griffith.edu.au.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Ryan', 'Affiliation': 'School of Applied Psychology, Griffith University, Australia.'}, {'ForeName': 'Camilla C', 'Initials': 'CC', 'LastName': 'Luck', 'Affiliation': 'School of Psychology, Curtin University, Australia.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, USA.'}, {'ForeName': 'Ottmar V', 'Initials': 'OV', 'LastName': 'Lipp', 'Affiliation': 'School of Psychology, Curtin University, Australia.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103921']
825,34214822,Targeting image-based autobiographical memory in childhood to prevent emotional disorders: Intervention development and a feasibility randomised controlled trial.,"Maladaptive cognitive styles confer vulnerability for emotional disorders and may emerge in childhood. In three phases, we developed and evaluated a novel parent-led intervention (My Memory Forest) to target overgeneral memory and avoidance of negative memories. In phase 1, the intervention was co-designed using two focus groups (n = 30 children) and consultation with teachers and parents. The acceptability, feasibility, and clinical potential of My Memory Forest was initially evaluated in phase two (n = 12 children aged 6 to 9) and then in a feasibility randomised controlled trial in phase three, against an active control (n = 56 aged 6 to 9). Acceptability and engagement were good, and no harm was reported by parents or participants. Phase 2 identified decreases in self-reported anxiety (d = 1.08), depression (d = 0.51) and vividness of negative events (d = 0.53). There was little change in parent-reported symptoms. In phase 3, recruitment was highly feasible and participant retention excellent (100%) but parent retention poor (55%). Descriptive statistics indicated similar changes in anxiety and depression for both groups. Changes between Phases 2 and 3 (e.g. methods of recruitment) could explain the discrepancy between results. Further development is necessary before proceeding to another trial. TRIAL REGISTRATION: ISRCTN13142918.",2021,Descriptive statistics indicated similar changes in anxiety and depression for both groups.,"['phase two (n\xa0=\xa012 children aged 6 to 9) and then in a feasibility randomised controlled trial in phase three, against an active control (n\xa0=\xa056 aged 6 to 9']",['Maladaptive cognitive styles'],"['depression', 'vividness of negative events', 'anxiety and depression', 'acceptability, feasibility, and clinical potential of My Memory Forest', 'self-reported anxiety ']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0563147', 'cui_str': 'Cognitive style'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",12.0,0.0669813,Descriptive statistics indicated similar changes in anxiety and depression for both groups.,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Pile', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Winstanley', 'Affiliation': ""Cultural Institute, King's College London, Artist, Illustrator and Arts and Wellbeing Project Producer, Lewes, East Sussex, UK.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Bennett', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Jennifer Y F', 'Initials': 'JYF', 'LastName': 'Lau', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, King's College London, London, UK. Electronic address: jennifer.lau@kcl.ac.uk.""}]",Behaviour research and therapy,['10.1016/j.brat.2021.103913']
826,34219221,Brain network modularity predicts changes in cortical thickness in children involved in a physical activity intervention.,"Individual differences in brain network modularity at baseline can predict improvements in cognitive performance after cognitive and physical interventions. This study is the first to explore whether brain network modularity predicts changes in cortical brain structure in 8- to 9-year-old children involved in an after-school physical activity intervention (N = 62), relative to children randomized to a wait-list control group (N = 53). For children involved in the physical activity intervention, brain network modularity at baseline predicted greater decreases in cortical thickness in the anterior frontal cortex and parahippocampus. Further, for children involved in the physical activity intervention, greater decrease in cortical thickness was associated with improvements in cognitive efficiency. The relationships among baseline modularity, changes in cortical thickness, and changes in cognitive performance were not present in the wait-list control group. Our exploratory study has promising implications for the understanding of brain network modularity as a biomarker of intervention-related improvements with physical activity.",2021,"For children involved in the physical activity intervention, brain network modularity at baseline predicted greater decreases in cortical thickness in the anterior frontal cortex and parahippocampus.",['8- to 9-year-old children'],"['brain network modularity', 'school physical activity intervention']","['cortical thickness', 'cognitive efficiency', 'cognitive performance', 'cortical brain structure', 'cortical thickness, and changes in cognitive performance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0526253,"For children involved in the physical activity intervention, brain network modularity at baseline predicted greater decreases in cortical thickness in the anterior frontal cortex and parahippocampus.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Chaddock-Heyman', 'Affiliation': 'Beckman Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Weng', 'Affiliation': 'Department of Diagnostic Medicine, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Psyche', 'Initials': 'P', 'LastName': 'Loui', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Kienzler', 'Affiliation': 'Department of Psychology, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weisshappel', 'Affiliation': 'Beckman Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Drollette', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, USA.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Raine', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Westfall', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Shih-Chun', 'Initials': 'SC', 'LastName': 'Kao', 'Affiliation': 'Health and Kinesiology, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Dominika M', 'Initials': 'DM', 'LastName': 'Pindus', 'Affiliation': 'Beckman Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Baniqued', 'Affiliation': 'Helen Wills Neuroscience Institute, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Darla M', 'Initials': 'DM', 'LastName': 'Castelli', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': 'Beckman Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}]",Psychophysiology,['10.1111/psyp.13890']
827,34225335,Early clinical exposure improves medical students' recognition of the need for professionalism and interprofessional collaboration.,"BACKGROUND


Medical students in Taiwan start their clerkship in their fifth year. A lack of early clinical exposure can mean they have a lack of medical professionalism and collaborative practice. This study investigates whether early engagement in hospital-based clinical practice could improve their understanding of these requirements.
METHODS


From 2017 to 2019, a total of 59 medical students at the end of their third year joined a 2-week summer camp at the hospital. Every participant was assigned to work with one patient and they accompanied this patient throughout their hospital course. The students were also asked to interview other medical professionals within the hospital and to write up interview reports. In addition, they had to complete pre- and postcamp questionnaires which included 10 questions to evaluate their recognition of professionalism, doctor-patient relationships, and interprofessional collaboration. Answers to the questions were all rated using a 5-score Likert scale.
RESULTS


The total postcamp Likert scores were significantly increased after the 2-week training camp compared with the precourse scores (pre- vs postcourse: 44.08 ± 0.45 vs 46.66 ± 0.33, p < 0.001). In addition, the students' recognition of medical professionalism, the importance of communication with patients, and their respect for other medical professionals were significantly improved after the 2-week training.
CONCLUSION


Our data showed that early clinical exposure through a preclerkship summer camp can help medical students improve their recognition of medical professionalism and interprofessional collaboration.",2021,"The total post-camp Likert scores were significantly increased after the 2-week training camp compared with the pre-course scores (pre- vs. post-course: 44.08±0.45 vs. 46.66±0.33, p<0.001).","['From 2017 to 2019, a total of 59 medical students at the end of their 3rd year, joined a 2-week summer camp at the hospital', 'Medical students in Taiwan start their clerkship in their 5th year']",[],['total post-camp Likert scores'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",59.0,0.0760544,"The total post-camp Likert scores were significantly increased after the 2-week training camp compared with the pre-course scores (pre- vs. post-course: 44.08±0.45 vs. 46.66±0.33, p<0.001).","[{'ForeName': 'Ching-Chih', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Divisions of General Medicine, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Divisions of General Medicine, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Wen-Shin', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chiao-Lin', 'Initials': 'CL', 'LastName': 'Chuang', 'Affiliation': 'Divisions of General Medicine, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ling-Ju', 'Initials': 'LJ', 'LastName': 'Huang', 'Affiliation': 'Divisions of General Medicine, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Dai-Yin', 'Initials': 'DY', 'LastName': 'Lu', 'Affiliation': 'Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': 'Divisions of General Medicine, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Hui-Chi', 'Initials': 'HC', 'LastName': 'Hsu', 'Affiliation': 'Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000575']
828,34225321,Prenatal Exercise and Cardiovascular Health (PEACH) Study: Impact on the Vascular System.,"PURPOSE


Healthy pregnancy is typically associated with favorable vascular adaptations to both structure and function of the peripheral arteries. Exercise is independently associated with improvements in peripheral vascular health; however, the impact of exercise on prenatal adaptations is unclear. Therefore, we hypothesized that a structured aerobic exercise intervention between the second and third trimesters (TM2 and TM3, respectively) of pregnancy would augment the already-positive changes in vascular outcomes.
METHODS


We recruited 59 inactive pregnant women (<20 wk of gestation) and randomized them into control (standard care; n = 28) or exercise (moderate-intensity aerobic exercise, 3-4 d·wk-1, 25-40 min, 14 ± 1 wk; n = 31) conditions. Before and after the intervention, all women completed the comprehensive peripheral vascular assessment, which included blood markers of vascular health, carotid distensibility metrics, measures of arterial stiffness (pulse wave velocity), and [superficial] femoral artery reactivity during cold pressor test.
RESULTS


Carotid artery diameter increased from 6.5 to 6.9 mm (P < 0.001), and strain (%) decreased from 9.9% to 8.4% (P < 0.001). Carotid artery blood flow, compliance and distensibility coefficients, stiffness (β), distensibility (1/β), and elastic modulus were not different across gestation. Pulse wave velocity was not different across gestation. Superficial femoral artery diameter was increased from 5.4 to 5.6 mm (P = 0.004), whereas blood flow, conductance, and resistance at rest and during the cold pressor test were not different across gestation. None of our measures of vascular health were impacted by exercise.
CONCLUSIONS


We did not observe an impact of aerobic exercise on altering the changes across pregnancy in blood vessel health. However, the present study was conducted in women who were overall at low risk for developing gestational hypertension and should be interpreted with caution. Future work in high-risk women is needed.",2021,"Superficial femoral artery diameter was increased from 5.4 mm to 5.6 mm (p = 0.004) while blood flow, conductance, and resistance at rest and during CPT were not different across gestation.","['women who were overall at low risk for developing gestational hypertension and should be interpreted with caution', '59 inactive pregnant women (<20 weeks gestation) and randomized them into control (standard care; n = 28']","['aerobic exercise', 'structured aerobic exercise intervention', 'or exercise (moderate intensity aerobic exercise']","['Prenatal Exercise and Cardiovascular Health', 'Superficial femoral artery diameter', 'blood markers of vascular health, carotid distensibility metrics, measures of arterial stiffness (pulse wave velocity; PWV), and [superficial] femoral artery reactivity during cold pressor test (CPT', 'blood flow, conductance, and resistance at rest and during CPT', 'peripheral vascular health', 'vascular health', 'Carotid artery blood flow, compliance and distensibility coefficients, stiffness (β), distensibility (1/β), and Elastic modulus', 'Carotid artery diameter', 'PWV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}, {'cui': 'C1285553', 'cui_str': 'Interprets'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C2350289', 'cui_str': 'Young Modulus'}]",59.0,0.0227625,"Superficial femoral artery diameter was increased from 5.4 mm to 5.6 mm (p = 0.004) while blood flow, conductance, and resistance at rest and during CPT were not different across gestation.","[{'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Skow', 'Affiliation': 'Program for Pregnancy and Postpartum Health, Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, Alberta, CANADA.'}, {'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Steinback', 'Affiliation': ''}, {'ForeName': 'Margie H', 'Initials': 'MH', 'LastName': 'Davenport', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002736']
829,34229051,Concurrent Chemoradiation Therapy With or Without Nimotuzumab in Locally Advanced Squamous Cell Lung Cancer: A Phase 2 Randomized Trial.,"PURPOSE


The study aimed to evaluate the efficacy and safety of concurrent chemoradiation therapy (CCRT) combined with nimotuzumab in patients with unresectable stage III squamous cell lung cancer (SqCLC).
METHODS AND MATERIALS


A prospective, single-center, open-label, randomized phase 2 trial was performed in patients with unresectable stage III SqCLC. Patients were randomized to receive 65 Gy thoracic radiation over 5 weeks concurrent with docetaxel and cisplatin or the same CCRT regimen combined with 200 mg of nimotuzumab (NIMO-CCRT), administered weekly by intravenous infusion. The primary endpoint was overall survival. The secondary endpoints were progression-free survival, objective response rate, failure patterns, and treatment-related toxicity.
RESULTS


From August 2015 to June 2020, 126 patients with SqCLC were randomized. Four patients withdrew consent before the start of treatment, and 122 patients were included for analysis, including 57 in the NIMO-CCRT group and 65 in the CCRT group. The median OS was 24.9 months in the NIMO-CCRT group and 23.5 months in the CCRT group (P = .655). The median PFS was 12.1 months in the NIMO-CCRT group and 13.7 months in the CCRT group (P = .968). The NIMO-CCRT group had a significantly lower risk of brain metastasis, with adjusted subdistribution hazard ratio of 0.099 (95% confidence interval, 0.012-0.81; P = .031). The incidence of grade ≥3 pneumonitis (P = .894) and esophagitis (P = .974) was similar between the 2 arms. There was no grade 2 or higher skin toxicity in NIMO-CCRT group.
CONCLUSIONS


The coincident application of nimotuzumab with CCRT was well tolerated for locally advanced SCCL. The NIMO-CCRT group had an OS and PFS similar to that in the CCRT group, but a lower risk of brain metastasis. Further investigations are warranted.",2021,The incidence of grade ≥3 pneumonitis (P=0.894) and esophagitis (P=0.974) was similar between the two arms.,"['locally advanced squamous cell lung cancer', 'patients with unresectable stage III SqCLC', 'Four patients withdrew consent before the start of treatment and 122 patients were included for analysis, including 57 in the NIMO-CCRT group and 65 in the CCRT group', 'From August 2015 to June 2020, 126 patients with SqCLC', 'patients with unresectable stage III squamous cell lung cancer (SqCLC']","['nimotuzumab with CCRT', 'thoracic radiation', 'Concurrent chemoradiotherapy with or without nimotuzumab', 'docetaxel and cisplatin or the same CCRT regimen combined with 200mg of nimotuzumab (NIMO-CCRT', 'CCRT', 'concurrent chemoradiotherapy combined with nimotuzumab']","['overall survival', 'efficacy and safety', 'esophagitis', 'median PFS', 'progression-free survival, objective response rate, failure patterns and treatment-related toxicities', 'median OS', 'risk of brain metastasis', 'skin toxicity', 'incidence of grade ≥3 pneumonitis']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0149782', 'cui_str': 'Squamous cell carcinoma of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854993', 'cui_str': 'Lung squamous cell carcinoma stage III'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C1570308', 'cui_str': 'Nimotuzumab'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0028094', 'cui_str': 'Nimodipine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}]",126.0,0.115705,The incidence of grade ≥3 pneumonitis (P=0.894) and esophagitis (P=0.974) was similar between the two arms.,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qiu', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; GuangDong Association Study of Thoracic Oncology, Guangzhou, Guangdong, China.'}, {'ForeName': 'DaQuan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; GuangDong Association Study of Thoracic Oncology, Guangzhou, Guangdong, China.'}, {'ForeName': 'QiWen', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; GuangDong Association Study of Thoracic Oncology, Guangzhou, Guangdong, China.'}, {'ForeName': 'YingJia', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; GuangDong Association Study of Thoracic Oncology, Guangzhou, Guangdong, China.'}, {'ForeName': 'SuPing', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; GuangDong Association Study of Thoracic Oncology, Guangzhou, Guangdong, China.'}, {'ForeName': 'XiaoBo', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'JianLan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'JinYu', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'FangJie', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; GuangDong Association Study of Thoracic Oncology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chu', 'Initials': 'C', 'LastName': 'Chu', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; GuangDong Association Study of Thoracic Oncology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'YiMei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'YongHong', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; GuangDong Association Study of Thoracic Oncology, Guangzhou, Guangdong, China. Electronic address: liuhuisysucc@sina.com.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.06.032']
830,34232160,Refining determinants of associations of visit-to-visit blood pressure variability with cardiovascular risk: results from the Action to Control Cardiovascular Risk in Diabetes Trial.,"OBJECTIVES


As there is uncertainty about the extent to which baseline blood pressure level or cardiovascular risk modifies the relationship between blood pressure variability (BPv) and cardiovascular disease, we comprehensively examined the role of BPv in cardiovascular disease risk in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial.
METHODS


Using data from ACCORD, we examined the relationship of BPv with development of the primary CVD outcome, major coronary heart disease (CHD), and total stroke using time-dependent Cox proportional hazards models.
RESULTS


BPv was associated with the primary CVD outcome and major CHD but not stroke. The positive association with the primary CVD outcome and major CHD was more pronounced in low and high strata of baseline SBP (<120 and >140 mmHg) and DBP (<70 and >80 mmHg). The effect of BPv on CVD and CHD was more pronounced in those with both prior CVD history and low blood pressure. Dips, not elevations, in blood pressure appeared to drive these associations. The relationships were generally not attenuated by adjustment for mean blood pressure, medication adherence, or baseline comorbidities. A sensitivity analysis using CVD events from the long-term posttrial follow-up (ACCORDION) was consistent with the results from ACCORD.
CONCLUSION


In ACCORD, the effect of BPv on adverse cardiovascular (but not cerebrovascular) outcomes is modified by baseline blood pressure and prior CVD. Recognizing these more nuanced relationships may help improve risk stratification and blood pressure management decisions as well as provide insight into potential underlying mechanisms.",2021,The effect of BPv on CVD and CHD was more pronounced in those with both prior CVD history and low blood pressure.,['Diabetes (ACCORD'],[],"['blood pressure', 'BPv with development of the primary CVD outcome, major coronary heart disease (CHD), and total stroke using time-dependent Cox proportional hazards models', 'mean blood pressure, medication adherence, or baseline comorbidities', 'CVD and CHD']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1331475', 'cui_str': 'Has development'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0010235', 'cui_str': 'Cox Proportional Hazards Models'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",,0.208822,The effect of BPv on CVD and CHD was more pronounced in those with both prior CVD history and low blood pressure.,"[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Nuyujukian', 'Affiliation': 'Phoenix VA Healthcare System, Phoenix.'}, {'ForeName': 'Jin J', 'Initials': 'JJ', 'LastName': 'Zhou', 'Affiliation': 'Phoenix VA Healthcare System, Phoenix.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Koska', 'Affiliation': 'Phoenix VA Healthcare System, Phoenix.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Reaven', 'Affiliation': 'Phoenix VA Healthcare System, Phoenix.'}]",Journal of hypertension,['10.1097/HJH.0000000000002931']
831,34231281,Bromelain-based enzymatic debridement of chronic wounds: Results of a multicentre randomized controlled trial.,"Chronic wounds are estimated to affect over 6 million people annually in the United States with an estimated annual cost of $25 billion. Debridement represents a key step in their management and is considered a basic necessity to induce the functional process of tissue repair. However, there is an unmet need for an efficient rapid acting non-surgical debridement agent. Bromelain-based enzymatic debridement has been proven to provide an effective, selective and safe non-surgical debridement in deep burns. EscharEx (MediWound Ltd, Yavne, Israel), is a bromelain-based enzymatic debridement agent currently in development for chronic wounds. The aim of this study was to assess its safety and efficacy in chronic wounds. Seventy-three patients suffering from a lower extremity ulcer of diabetic/venous insufficiency/post-surgical/traumatic aetiology were enrolled in a multicentre, assessor blinded, randomized controlled trial. Patients were randomized to topical treatment by either EscharEx or its gel vehicle for up to 10 daily 4 hour applications, and then continued follow-up for up to 6 months. The EscharEx arm achieved a significantly higher incidence of complete debridement compared to the gel vehicle arm; 55 versus 29% (p = .047), thus meeting the primary endpoint of this study. The EscharEx and gel vehicle arms achieved similar reductions in wound area, non-viable tissue area and wound healing scores during the debridement period. There were no significant differences between the arms in the incidence of complete wound closure (41% in the EsxcharEx arm vs. 53% in the gel vehicle arm) and in the mean time to complete wound closure (70.0 ± 32.8 days in the EsxcharEx arm vs. 65.7 ± 38.4 days in gel vehicle arm). There were no significant safety issues and EscharEx demonstrated a favourable benefit to risk profile.",2021,"The EscharEx and gel vehicle arms achieved similar reductions in wound area, non-viable tissue area and wound healing scores during the debridement period.","['chronic wounds', 'Seventy-three patients suffering from a lower extremity ulcer of diabetic/venous insufficiency/post-surgical/traumatic aetiology']","['Bromelain-based enzymatic debridement', 'EscharEx or its gel vehicle', 'EscharEx']","['incidence of complete debridement', 'mean time to complete wound closure', 'safety and efficacy', 'incidence of complete wound closure', 'wound area, non-viable tissue area and wound healing scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023223', 'cui_str': 'Ulcer of lower extremity'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0042485', 'cui_str': 'Peripheral venous insufficiency'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C0006217', 'cui_str': 'Bromelains'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",73.0,0.05048,"The EscharEx and gel vehicle arms achieved similar reductions in wound area, non-viable tissue area and wound healing scores during the debridement period.","[{'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Shoham', 'Affiliation': 'Plastic and Reconstructive Surgery Department and Burn Unit, Soroka University Medical Center, Beer Sheba, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Shapira', 'Affiliation': 'Plastic and Reconstructive Surgery Department, Shamir Medical Center, Zerifin, Israel.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Haik', 'Affiliation': 'Plastic and Reconstructive Surgery Department and Burn Center, Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Moti', 'Initials': 'M', 'LastName': 'Harats', 'Affiliation': 'Plastic and Reconstructive Surgery Department and Burn Center, Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Egozi', 'Affiliation': 'Plastic and Reconstructive Surgery Department, Kaplan Medical Center, Rehovot, Israel.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Robinson', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Kogan', 'Affiliation': 'Plastic Surgery and Burns Department, Galilee Medical Center, Naharia, Israel.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Elkhatib', 'Affiliation': 'Plastic and Reconstructive Surgery Department, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Geza', 'Initials': 'G', 'LastName': 'Telek', 'Affiliation': 'Surgery Department, South Pest Central Hospital, National Institute of Hematology and Infectious Diseases, and 1st. Department of Surgery and Interventional Gastroenterology (DPC Surgical Department Group), Faculty of Medicine, Faculty of Dentistry, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Avshalom', 'Initials': 'A', 'LastName': 'Shalom', 'Affiliation': 'Plastic and Reconstructive Surgery Department, Meir Medical Center, Kfar Saba, Israel.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12958']
832,34235780,Acute health effects from exposure to indoor ultrafine particles-A randomized controlled crossover study among young mild asthmatics.,"Particulate matter is linked to adverse health effects, however, little is known about health effects of particles emitted from typical indoor sources. We examined acute health effects of short-term exposure to emissions from cooking and candles among asthmatics. In a randomized controlled double-blinded crossover study, 36 young non-smoking asthmatics attended three exposure sessions lasting 5 h: (a) air mixed with emissions from cooking (fine particle mass concentration): (PM 2.5  : 96.1 μg/m 3  ), (b) air mixed with emissions from candles (PM 2.5  : 89.8 μg/m 3  ), and c) clean filtered air (PM 2.5  : 5.8 μg/m 3  ). Health effects (spirometry, fractional exhaled Nitric Oxide [FeNO], nasal volume and self-reported symptoms) were evaluated before exposure start, then 5 and 24 h after. During exposures volatile organic compounds (VOCs), particle size distributions, number concentrations and optical properties were measured. Generally, no statistically significant changes were observed in spirometry, FeNO, or nasal volume comparing cooking and candle exposures to clean air. In males, nasal volume and FeNO decreased after exposure to cooking and candles, respectively. Participants reported additional and more pronounced symptoms during exposure to cooking and candles compared to clean air. The results indicate that emissions from cooking and candles exert mild inflammation in asthmatic males and decrease comfort among asthmatic males and females.",2021,"Generally, no statistically significant changes were observed in spirometry, FeNO, or nasal volume comparing cooking and candle exposures to clean air.","['36 young non-smoking asthmatics attended three', 'young mild asthmatics', 'asthmatics']",['exposure sessions lasting 5\xa0h: (a) air mixed with emissions from cooking (fine particle mass concentration'],"['spirometry, FeNO, or nasal volume comparing cooking and candle exposures to clean air', 'nasal volume and FeNO', 'Health effects (spirometry, fractional exhaled Nitric Oxide [FeNO], nasal volume and self-reported symptoms']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0560150', 'cui_str': 'Mass concentration'}]","[{'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C1850568', 'cui_str': 'Nakajo-Nishimura syndrome'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",36.0,0.0365316,"Generally, no statistically significant changes were observed in spirometry, FeNO, or nasal volume comparing cooking and candle exposures to clean air.","[{'ForeName': 'Karin Rosenkilde', 'Initials': 'KR', 'LastName': 'Laursen', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Berit Brøndum', 'Initials': 'BB', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Chemistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Rosati', 'Affiliation': 'Department of Chemistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Vibeke Heitmann', 'Initials': 'VH', 'LastName': 'Gutzke', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Østergaard', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ravn', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Søren Kenneth', 'Initials': 'SK', 'LastName': 'Kjaergaard', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Bilde', 'Affiliation': 'Department of Chemistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Glasius', 'Affiliation': 'Department of Chemistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Sigsgaard', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Indoor air,['10.1111/ina.12902']
833,34242310,Processing of expressions by individuals with autistic traits: Empathy deficit or sensory hyper-reactivity?,"Individuals with autistic traits display impaired social interaction and communication in everyday life, but the underlying cognitive neural mechanisms remain very unclear and still remain controversial. The mind-blindness hypothesis suggests that social difficulties in individuals with autistic traits are caused by empathy impairment in individuals; however, the intense world theory suggests that these social difficulties are caused by sensory hyper-reactivity and sensory overload, rather than empathy impairment. To further test these two theories, this study investigated event-related potentials (ERPs) to explore the cognitive neural processing of repetitive expressions in individuals with autistic traits. This study employed the Mandarin version of the autism-spectrum quotient (AQ) to assess autistic traits in 2,502 healthy adults. Two subset groups were used, e.g., the participants of a high-AQ group were randomly selected among the 10% of individuals with the highest AQ scores; similarly, the participants in the low-AQ group were randomly selected from the 10% of participants with the lowest AQ scores. In an experiment, three different facial expressions (positive, neutral, or negative) of the same person were presented successively and pseudo-randomly in each trial. Participants needed to define the expression of the face that was presented last. The results showed that compared with the low-AQ group, the high-AQ group exhibited higher P1 amplitudes induced by the second and third presented expressions, as well as higher P3 amplitudes induced by the third presented negative expressions. This indicates that individuals with autistic traits may experience overly strong perception, attention, and cognitive evaluation to repetitive expressions, particularly negative expressions. This result supports the intense world theory more strongly than the mind-blindness hypothesis.",2021,"The results showed that compared with the low-AQ group, the high-AQ group exhibited higher P1 amplitudes induced by the second and third presented expressions, as well as higher P3 amplitudes induced by the third presented negative expressions.","['2,502 healthy adults', 'Individuals with autistic traits', 'individuals with autistic traits']",['Mandarin version of the autism-spectrum quotient (AQ'],"['P1 amplitudes', 'P3 amplitudes']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]",[],2502.0,0.0279005,"The results showed that compared with the low-AQ group, the high-AQ group exhibited higher P1 amplitudes induced by the second and third presented expressions, as well as higher P3 amplitudes induced by the third presented negative expressions.","[{'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': 'Key Laboratory of Applied Psychology, Chongqing Normal University, Chongqing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huo', 'Affiliation': 'Key Laboratory of Applied Psychology, Chongqing Normal University, Chongqing, China.'}, {'ForeName': 'Hongxin', 'Initials': 'H', 'LastName': 'Ge', 'Affiliation': 'Key Laboratory of Applied Psychology, Chongqing Normal University, Chongqing, China.'}, {'ForeName': 'Zuoshan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Applied Psychology, Chongqing Normal University, Chongqing, China.'}, {'ForeName': 'Yuanyan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Laboratory of Emotion and Mental Health, Chongqing University of Arts and Sciences, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': 'Key Laboratory of Applied Psychology, Chongqing Normal University, Chongqing, China.'}]",PloS one,['10.1371/journal.pone.0254207']
834,34242270,Does a learner-centered approach using teleconference improve medical students' psychological safety and self-explanation in clinical reasoning conferences? a crossover study.,"During clinical reasoning case conferences, a learner-centered approach using teleconferencing can create a psychologically safe environment and help learners speak up. This study aims to measure the psychological safety of students who are supposed to self-explain their clinical reasoning to conference participants. This crossover study compared the effects of two clinical reasoning case conference methods on medical students' psychological safety. The study population comprised 4th-5th year medical students participating in a two-week general medicine clinical clerkship rotation, from September 2019 to February 2020. They participated in both a learner-centered approach teleconference and a traditional, live-style conference. Teleconferences were conducted in a separate room, with only a group of students and one facilitator. Participants in group 1 received a learner-centered teleconference in the first week and a traditional, live-style conference in the second week. Participants assigned to group 2 received a traditional, live-style conference in the first week and a learner-centered approach teleconference in the second week. After each conference, Edmondson's Psychological Safety Scale was used to assess the students' psychological safety. We also counted the number of students who self-explained their clinical reasoning processes during each conference. Of the 38 students, 34 completed the study. Six out of the seven psychological safety items were significantly higher in the learner-centered approach teleconferences (p<0.01). Twenty-nine (85.3%) students performed self-explanation in the teleconference compared to ten (29.4%) in the live conference (p<0.01). A learner-centered approach teleconference could improve psychological safety in novice learners and increase the frequency of their self-explanation, helping educators better assess their understanding. Based on these results, a learner-centered teleconference approach has the potential to be a method for teaching clinical reasoning to medical students.",2021,Six out of the seven psychological safety items were significantly higher in the learner-centered approach teleconferences (p<0.01).,"['students who are supposed to self-explain their clinical reasoning to conference participants', 'medical students', 'study population comprised 4th-5th year medical students participating in a two-week general medicine clinical clerkship rotation, from September 2019 to February 2020', '38 students, 34 completed the study']","['Teleconferences', 'traditional, live-style conference in the first week and a learner-centered approach teleconference', 'learner-centered teleconference']",['psychological safety'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0008955', 'cui_str': 'Clerkships, Clinical'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0497368,Six out of the seven psychological safety items were significantly higher in the learner-centered approach teleconferences (p<0.01).,"[{'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Hoshina', 'Affiliation': 'Department of General Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Shikino', 'Affiliation': 'Department of General Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Yamauchi', 'Affiliation': 'Department of General Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Yanagita', 'Affiliation': 'Department of General Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Yokokawa', 'Affiliation': 'Department of General Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of General Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Noda', 'Affiliation': 'Department of General Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Uehara', 'Affiliation': 'Department of General Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masatomi', 'Initials': 'M', 'LastName': 'Ikusaka', 'Affiliation': 'Department of General Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}]",PloS one,['10.1371/journal.pone.0253884']
835,34245652,The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis.,"OBJECTIVE


To evaluate the costs and non-inferiority of a strategy starting with the levonorgestrel intrauterine system (LNG-IUS) compared with endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB).
DESIGN


Cost-effectiveness analysis from a societal perspective alongside a multicentre randomised non-inferiority trial.
SETTING


General practices and gynaecology departments in the Netherlands.
POPULATION


In all, 270 women with HMB, aged ≥34 years old, without intracavitary pathology or wish for a future child.
METHODS


Randomisation to a strategy starting with the LNG-IUS (n = 132) or EA (n = 138). The incremental cost-effectiveness ratio was estimated.
MAIN OUTCOME MEASURES


Direct medical costs and (in)direct non-medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)-score (non-inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC-score ≤75 points).
RESULTS


Total costs per patient were €2,285 in the LNG-IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months, mean PBAC-scores were 64.8 in the LNG-IUS group (n = 115) and 14.2 in the EA group (n = 132); difference 50.5 points (95% CI 4.3-96.7). In the LNG-IUS group, 87% of women had a PBAC-score ≤75 points versus 94% in the EA group (relative risk [RR] 0.93, 95% CI 0.85-1.01). The ICER was €23 (95% CI €5-111) per PBAC-point.
CONCLUSIONS


A strategy starting with the LNG-IUS was cheaper than starting with EA, but non-inferiority could not be demonstrated. The LNG-IUS is reversible and less invasive and can be a cost-effective treatment option, depending on the success rate women are willing to accept.
TWEETABLE ABSTRACT


Treatment of heavy menstrual bleeding starting with LNG-IUS is cheaper but slightly less effective than endometrial ablation.",2021,"RESULTS


Total costs per patient were €2,285 in the LNG-IUS strategy and €3,465 in the EA strategy (difference: €1,180).","['270 women with HMB, aged ≥34 years old, without intracavitary pathology or future child wish', 'n=132) or EA (n=138', 'heavy menstrual bleeding (HMB', 'heavy menstrual bleeding', 'General practices and gynaecology departments in the Netherlands']","['LNG-IUS compared to endometrial ablation (EA', 'LNG-IUS', 'levonorgestrel intrauterine system versus endometrial ablation']","['Direct medical costs and (in)direct non-medical costs', 'incremental cost-effectiveness ratio (ICER', 'menstrual blood loss', 'mean Pictorial Blood Assessment Chart (PBAC)-score', 'PBAC-scores', 'successful blood loss reduction (PBAC-score ≤75 points']","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1298613', 'cui_str': 'Intracavitary'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0587481', 'cui_str': 'Gynecology department'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",270.0,0.150925,"RESULTS


Total costs per patient were €2,285 in the LNG-IUS strategy and €3,465 in the EA strategy (difference: €1,180).","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'van den Brink', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Beelen', 'Affiliation': 'Department of General Practice, University of Maastricht, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Herman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Geomini', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Dekker', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Berger', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16836']
836,34225270,Membranous Nephropathy: It Is Time to Go Back to the Future.,"CONTEXT


Membranous nephropathy (MN) is an immune-mediated glomerular disease that can lead to nephrotic syndrome and progressive kidney function loss. The cyclic steroid-cyclophosphamide regimen (the modified Ponticelli protocol) and the monoclonal anti-CD20 antibody rituximab have been advocated as effective therapies to improve renal outcomes, but a direct comparison of these treatments had never been carried out in a prospective study. Subject of Review: Scolari et al. [J Am Soc Nephrol. 2021;32:972-82] recently reported the results of a pilot randomized controlled trial (RI-CYCLO) designed to provide direct estimates of the effect of rituximab (1 g × 2) compared to the cyclic steroid-cyclophosphamide regimen in 74 patients with MN. The proportion of patients with complete remission at 12 months was higher in the cyclic regimen arm than that of rituximab (32 and 16%, respectively), but the difference was not statistically significant in intention-to-treat analyses. Interestingly, differences in the cumulative incidence of complete and partial remissions between treatment arms progressively reduced over the follow-up and became virtually nonexistent from 24 months (>80% in both groups). The frequency of serious and nonserious adverse events was similar between the 2 treatment arms. Infusion reactions and drug discontinuation were more common with rituximab, while infections and leukopenia were more frequently observed with the cyclic regimen. The risk of cancer was similar in the 2 allocation groups, but the limited follow-up length did not allow to draw definitive conclusions. Independent of treatment allocation, 18% of patients experienced at least 1 relapse after achieving complete or partial remission. Second Opinion: Notwithstanding the intrinsic limitations of a pilot study, the RI-CYCLO trial represents an important milestone in the treatment of MN. Findings from this study support the hypothesis that the cyclic regimen and rituximab may have comparable efficacy in inducing disease remission over the long term. Considering its potentially better-albeit not yet formally proven-long-term safety profile, rituximab could be considered as a first-line therapy for most patients with MN. Several questions remain to be addressed, including rituximab ideal dose and its efficacy in patients with a significant reduction in glomerular filtration rate. In light of RI-CYCLO results, a large-scale trial to assess rituximab noninferiority to the cyclic regimen would require the enrollment of thousands of patients, and it would be probably unfeasible within a reasonable time frame. In our opinion, resources should be allocated to provide an answer to the pressing matter of treatment nonresponse and intolerance, which may be addressed in the near future with novel therapeutic strategies.",2021,"Interestingly, differences in the cumulative incidence of complete and partial remissions between treatment arms progressively reduced over the follow-up and became virtually nonexistent from 24 months (>80% in both groups).","['Membranous Nephropathy', '74 patients with MN']","['cyclic steroid-cyclophosphamide', 'rituximab']","['glomerular filtration rate', 'infections and leukopenia', 'risk of cancer', 'proportion of patients with complete remission', 'cumulative incidence of complete and partial remissions', 'frequency of serious and nonserious adverse events', 'disease remission']","[{'cui': 'C0017665', 'cui_str': 'Membranous glomerulonephritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.0407702,"Interestingly, differences in the cumulative incidence of complete and partial remissions between treatment arms progressively reduced over the follow-up and became virtually nonexistent from 24 months (>80% in both groups).","[{'ForeName': 'Gianmarco', 'Initials': 'G', 'LastName': 'Sabiu', 'Affiliation': 'Nephrology Unit, ASST Fatebenefratelli Sacco, Department of Biomedical and Clinical Sciences ""Luigi Sacco,"" University of Milan, Milan, Italy.'}, {'ForeName': 'Manuel Alfredo', 'Initials': 'MA', 'LastName': 'Podestà', 'Affiliation': 'Renal Division, ASST Santi Paolo e Carlo, Department of Health Sciences, University of Milan, Milan, Italy.'}]",Nephron,['10.1159/000516984']
837,34231231,"Controlled breathing and pain: Respiratory rate and inspiratory loading modulate cardiovascular autonomic responses, but not pain.","Slow, deep breathing (SDB) is a common pain self-management technique. Stimulation of the arterial baroreceptors and vagal modulation are suggested, among others, as potential mechanisms underlying the hypoalgesic effects of SDB. We tested whether adding an inspiratory load to SDB, which results in a stronger baroreceptor stimulation and vagal modulation, enhances its hypoalgesic effects. Healthy volunteers performed SDB (controlled at 0.1 Hz) with and without an inspiratory threshold load. Controlled breathing (CB) at a normal frequency (0.23 Hz) was used as an active control. Each condition lasted 90 s, included an electrical pain stimulation on the hand, and was repeated four times in a randomized order. Pain intensity, self-reported emotional responses (arousal, valence, dominance), and cardiovascular parameters (including vagally-mediated heart rate variability) were measured per trial. A cover story was used to limit the potential effect of outcome expectancy. Pain intensity was slightly lower during SDB with load compared with normal-frequency CB, but the effect was negligible (Cohens d < 0.2), and there was no other difference in pain intensity between the conditions. Heart rate variability was higher during SDB with/without load compared with normal-frequency CB. Using load during SDB was associated with higher heart rate variability, but less favorable emotional responses. These findings do not support the role of baroreceptor stimulation or vagal modulation in the hypoalgesic effects of SDB. Other mechanisms, such as attentional modulation, warrant further investigation.",2021,"Pain intensity was slightly lower during SDB with load compared with normal-frequency CB, but the effect was negligible",['Healthy volunteers performed SDB (controlled at 0.1\xa0Hz) with and without an inspiratory threshold load'],"['Slow, deep breathing (SDB', 'Controlled breathing (CB']","['Controlled breathing and pain', 'heart rate variability', 'favorable emotional responses', 'Respiratory rate and inspiratory loading modulate cardiovascular autonomic responses', 'pain intensity', 'Heart rate variability', 'Pain intensity, self-reported emotional responses (arousal, valence, dominance), and cardiovascular parameters (including vagally-mediated heart rate variability', 'Pain intensity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]",,0.0299438,"Pain intensity was slightly lower during SDB with load compared with normal-frequency CB, but the effect was negligible","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Gholamrezaei', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies, Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism, and Ageing, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Van Diest', 'Affiliation': 'Health Psychology Research Group, Faculty of Psychology and Educational Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Qasim', 'Initials': 'Q', 'LastName': 'Aziz', 'Affiliation': 'Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Wingate Institute of Neurogastroeneterology, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Johan W S', 'Initials': 'JWS', 'LastName': 'Vlaeyen', 'Affiliation': 'Health Psychology Research Group, Faculty of Psychology and Educational Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies, Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism, and Ageing, KU Leuven, Leuven, Belgium.'}]",Psychophysiology,['10.1111/psyp.13895']
838,34228770,Roles of parasympathetic outflow and sympathetic outflow in the cardiovascular response to brief umbilical cord occlusion in fetal sheep.,"Fetal heart rate (FHR) deceleration is the most common change seen during labor. The role of the autonomic nervous system in regulating the fetal cardiovascular response during multiple uterine contractions has been well-established. However, the mechanism underlying the hemodynamic response remains unclear and the specific reflex that mediates the cardiovascular modifications is still controversial. This study aimed to determine the role of the sympathetic and parasympathetic systems on fetal hemodynamics in complete cord occlusion. Chronically instrumented fetal sheep were randomized to receive an intravenous injection of atropine 2.5 mg (n = 8), propranolol 5 mg (n = 7), atropine and propranolol (n = 7), or a control protocol (n = 9), followed by three episodes of 1-minute umbilical cord occlusion repeated every 5 minutes. Cord compression induces a rapid decrease in the FHR and a rapid increase in MAP. The decrease in FHR is caused by an increase in parasympathetic activity, (atropine and atropine-propranolol abolish the FHR response to the occlusion). The change in FHR during occlusion was not modified by propranolol injection, showing no effect of sympathetic tone. The increase in MAP during occlusion was similar in the four protocols. After releasing occlusion, the FHR was still lower than that at baseline due to a sustained parasympathetic tone. Suppression of the parasympathetic output to the cardiovascular system unmasks an increase in the FHR above baseline values. The lower FHR with the propranolol protocol further supports an increase in myocardial β-adrenoceptor stimulation after cord release. The increase in MAP after cord release was similar in the four protocols, except after the early stage of interocclusion period in atropine protocol. Four minutes after cord release, the FHR returned to baseline irrespective of the drugs that were infused, thereby showing recovery of ANS control. Blood gases (pH, PaCO2, PaO2) and plasma lactate concentrations was similar between the four protocols at the end of three applications of UCO. Complete cord compression-induced deceleration is likely due to acute activation of parasympathetic output. β-adrenoceptor activity is involved in the increase in FHR after cord release. Understanding the reflexes involved in FHR deceleration may help us understand the mechanisms underlying fetal autonomic adaptation during cord occlusion.",2021,"The increase in MAP after cord release was similar in the four protocols, except after the early stage of interocclusion period in atropine protocol.","['fetal sheep', 'Chronically instrumented fetal sheep']","['atropine and propranolol', 'propranolol', 'intravenous injection of atropine']","['change in FHR', 'Blood gases (pH, PaCO2, PaO2) and plasma lactate concentrations', 'β-adrenoceptor activity', 'Fetal heart rate (FHR) deceleration', 'MAP after cord release', 'parasympathetic activity', 'MAP during occlusion', 'FHR', 'myocardial β-adrenoceptor stimulation']","[{'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0036945', 'cui_str': 'Genus Ovis'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",9.0,0.0817856,"The increase in MAP after cord release was similar in the four protocols, except after the early stage of interocclusion period in atropine protocol.","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Recher', 'Affiliation': 'Univ. Lille, ULR 2694 - METRICS: Evaluation des technologies de santé et des pratiques médicales, Lille, France.'}, {'ForeName': 'Arthur Lauriot Dit', 'Initials': 'ALD', 'LastName': 'Prevost', 'Affiliation': 'Univ. Lille, ULR 2694 - METRICS: Evaluation des technologies de santé et des pratiques médicales, Lille, France.'}, {'ForeName': 'Dyuti', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Univ. Lille, ULR 2694 - METRICS: Evaluation des technologies de santé et des pratiques médicales, Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'De Jonckheere', 'Affiliation': 'Univ. Lille, ULR 2694 - METRICS: Evaluation des technologies de santé et des pratiques médicales, Lille, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Garabedian', 'Affiliation': 'Univ. Lille, ULR 2694 - METRICS: Evaluation des technologies de santé et des pratiques médicales, Lille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Storme', 'Affiliation': 'Univ. Lille, ULR 2694 - METRICS: Evaluation des technologies de santé et des pratiques médicales, Lille, France.'}]",PloS one,['10.1371/journal.pone.0254155']
839,34233225,"Validation of novel recipes for masking peanuts in double-blind, placebo-controlled food challenges.","BACKGROUND


Double-blind, placebo-controlled oral food challenges are the gold standard in food allergy diagnosis. Nevertheless, proper masking of peanuts is particularly complex owing to their intense flavor and odor. Thus, it is important to use validated recipes to ensure their adequate masking during oral food challenges.
OBJECTIVE


To design and validate recipes containing masked peanuts for double-blind, placebo-controlled oral food challenges.
METHODS


Two types of products (cookies and a custard‑type dessert) containing the masked peanuts and other ingredients with low allergenic potential were designed and validated. For this purpose, of the 24 initial cookie recipes and 12 initial custard recipes developed, those that did not exhibit significant differences in their texture were selected for sensory validation.
RESULTS


Similarity triangle tests were performed using a panel of 36 selected tasters, enabling the validation of 1 pair of cookie recipes and 1 pair of custard-type dessert recipe, both with low allergenic potential and suitable for those with celiac disease and for vegans.
CONCLUSION


The validated recipes are of clinical and research interest because they allow to confirm a peanut allergy and detect a wide range of tolerated threshold doses, which makes it possible to provide specific indications for each patient.",2021,"For this purpose, out of the 24 initial cookie recipes and 12 initial custard recipes developed, those that did not exhibit significant differences in their texture were selected for sensory validation.
",['two types of products (cookies and a custard-type dessert) containing the masked peanuts and other ingredients with low allergenic potential were designed and validated'],['placebo'],[],"[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0453512', 'cui_str': 'Custard'}, {'cui': 'C0453505', 'cui_str': 'Dessert'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.22917,"For this purpose, out of the 24 initial cookie recipes and 12 initial custard recipes developed, those that did not exhibit significant differences in their texture were selected for sensory validation.
","[{'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Lafón', 'Affiliation': 'Department of Agronomy, Biotechnology, and Food Science, Public University of Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lampérez', 'Affiliation': 'Department of Agronomy, Biotechnology, and Food Science, Public University of Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Navarro', 'Affiliation': 'Department of Agronomy, Biotechnology, and Food Science, Public University of Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gastaminza', 'Affiliation': 'Department of Allergology, Clínica Universidad de Navarra, Pamplona, Spain; Spanish Research Network on Asthma, Adverse Drug Reactions, and Allergy (ARADyAL, Red Nacional de Asma, Reacciones Adversas a Fármacos y Alergia) of the Carlos III Health Institute of Madrid, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ferrer', 'Affiliation': 'Department of Allergology, Clínica Universidad de Navarra, Pamplona, Spain; Spanish Research Network on Asthma, Adverse Drug Reactions, and Allergy (ARADyAL, Red Nacional de Asma, Reacciones Adversas a Fármacos y Alergia) of the Carlos III Health Institute of Madrid, Madrid, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Tabar', 'Affiliation': 'Spanish Research Network on Asthma, Adverse Drug Reactions, and Allergy (ARADyAL, Red Nacional de Asma, Reacciones Adversas a Fármacos y Alergia) of the Carlos III Health Institute of Madrid, Madrid, Spain; Allergology Service, Hospital Complex of Navarra, Navarra, Pamplona, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gómez', 'Affiliation': 'InnoUp Farma S.L., Pamplona, Navarra, Spain.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Agüeros', 'Affiliation': 'InnoUp Farma S.L., Pamplona, Navarra, Spain.'}, {'ForeName': 'Blanca E', 'Initials': 'BE', 'LastName': 'García', 'Affiliation': 'Spanish Research Network on Asthma, Adverse Drug Reactions, and Allergy (ARADyAL, Red Nacional de Asma, Reacciones Adversas a Fármacos y Alergia) of the Carlos III Health Institute of Madrid, Madrid, Spain; Allergology Service, Hospital Complex of Navarra, Navarra, Pamplona, Spain.'}, {'ForeName': 'Carmen M', 'Initials': 'CM', 'LastName': ""D'Amelio"", 'Affiliation': 'Department of Allergology, Clínica Universidad de Navarra, Pamplona, Spain; Spanish Research Network on Asthma, Adverse Drug Reactions, and Allergy (ARADyAL, Red Nacional de Asma, Reacciones Adversas a Fármacos y Alergia) of the Carlos III Health Institute of Madrid, Madrid, Spain. Electronic address: cdamelio@unav.es.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2021.06.024']
840,34242497,"Effect of Silymarin Treatment on Circulating Bilirubin and Cardiovascular Disease Risk Factors in Healthy Men: A Single-Blind, Randomized Crossover Trial.","This clinical trial (ACTRN12619001296123) investigated the impact of silymarin (Legalon®) on circulating bilirubin concentration, lipid status, systemic inflammation, and antioxidant status. The study design was a randomized, placebo-controlled, single-blind crossover trial of healthy men (18-65 years), conducted at Griffith University, Gold Coast, Australia. Participants were recruited from Griffith University and were randomized to silymarin (140 mg silymarin capsules thrice daily) or placebo (3 capsules containing mannitol taken daily) for 14 days followed by a ≥4-week washout and crossover to the other arm. The main outcomes were whether silymarin treatment would increase serum bilirubin concentration by >0.29 mg/dL, change serum lipid status (cholesterol and triglycerides), inflammation (c-reactive protein), and antioxidant capacity (ferric reducing ability of plasma) compared with baseline. Silymarin consumption (n = 17) did not affect serum concentrations of unconjugated bilirubin (0.73 versus 0.67 mg/dL, P = .79), cholesterol (185 versus 189 mg/dL, P = .19), triglycerides (94.2 versus 92.3 mg/dL, P = .79), c-reactive protein (0.17 versus 0.09 mg/dL, P = .23), or antioxidant status (6.61 versus 6.67 mg Fe 2+  /dL, P = .40). These findings challenge previous reports and manufacturer claims of hyperbilirubinemia following silymarin treatment and are critical to guiding researchers toward an effective means to mildly elevate bilirubin, which evidence suggests could protect from cardiovascular disease.",2021,"Silymarin consumption (n = 17) did not affect serum concentrations of unconjugated bilirubin (0.73 versus 0.67 mg/dL, P = .79), cholesterol (185 versus 189 mg/dL, P = .19), triglycerides (94.2 versus 92.3 mg/dL, P = .79), c-reactive protein (0.17 versus 0.09 mg/dL, P = .23), or antioxidant status (6.61 versus 6.67 mg Fe 2+  /dL, P = .40).","['Healthy Men', 'healthy men (18-65 years), conducted at Griffith University, Gold Coast, Australia', 'Participants were recruited from Griffith University']","['silymarin (Legalon®', 'placebo', 'silymarin', 'Silymarin Treatment']","['serum lipid status (cholesterol and triglycerides), inflammation (c-reactive protein), and antioxidant capacity (ferric reducing ability of plasma', 'cholesterol', 'circulating bilirubin concentration, lipid status, systemic inflammation, and antioxidant status', 'serum concentrations of unconjugated bilirubin', 'antioxidant status', 'triglycerides', 'c-reactive protein', 'serum bilirubin concentration', 'Silymarin consumption', 'Circulating Bilirubin and Cardiovascular Disease Risk Factors']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0037135', 'cui_str': 'Silymarin'}, {'cui': 'C0600330', 'cui_str': 'Legalon'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0427734', 'cui_str': 'Bilirubin concentration, test strip measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0301719', 'cui_str': 'Indirect reacting bilirubin'}, {'cui': 'C0428441', 'cui_str': 'Serum bilirubin measurement'}, {'cui': 'C0037135', 'cui_str': 'Silymarin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",,0.20415,"Silymarin consumption (n = 17) did not affect serum concentrations of unconjugated bilirubin (0.73 versus 0.67 mg/dL, P = .79), cholesterol (185 versus 189 mg/dL, P = .19), triglycerides (94.2 versus 92.3 mg/dL, P = .79), c-reactive protein (0.17 versus 0.09 mg/dL, P = .23), or antioxidant status (6.61 versus 6.67 mg Fe 2+  /dL, P = .40).","[{'ForeName': 'Josif', 'Initials': 'J', 'LastName': 'Vidimce', 'Affiliation': 'School of Pharmacy and Medical Science, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Evan Noel', 'Initials': 'EN', 'LastName': 'Pennell', 'Affiliation': 'School of Pharmacy and Medical Science, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Maxmilian', 'Initials': 'M', 'LastName': 'Foo', 'Affiliation': 'School of Pharmacy and Medical Science, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Ryan Graeme', 'Initials': 'RG', 'LastName': 'Shiels', 'Affiliation': 'School of Pharmacy and Medical Science, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Sapha', 'Initials': 'S', 'LastName': 'Shibeeb', 'Affiliation': 'School of Pharmacy and Medical Science, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Watson', 'Affiliation': 'Institute of Health & Biomedical Innovation, Translational Research Institute, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Andrew Cameron', 'Initials': 'AC', 'LastName': 'Bulmer', 'Affiliation': 'School of Pharmacy and Medical Science, Griffith University, Gold Coast, Queensland, Australia.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.962']
841,34251751,Ten kHz spinal cord stimulation for the treatment of chronic peripheral polyneuropathy: 12-Month results from prospective open-label pilot study.,"BACKGROUND


The goal of this study was to demonstrate that the paresthesia-independent 10 kHz spinal cord stimulation (SCS) can provide long-term pain relief in patients with peripheral polyneuropathy (PPN). Clinically diagnosed subjects with PPN refractory to conventional medical management were enrolled in this prospective, multicenter study between November 2015 and August 2016, after institutional review board approval and patient informed consent were obtained.
METHODS


Subjects underwent trial stimulation utilizing 2 epidural leads, and if successful, were implanted with a permanent 10 kHz SCS system and followed up for 12 months post-implant. Outcome measures included adverse events, pain, neurological assessments, disability, function, quality of life, pain interference, sleep, satisfaction, and global impression of change. Data are presented as descriptive statistics. Permanent implant population results are reported as mean ± standard error.
RESULTS


Twenty-one of the 26 trialed subjects had a successful trial and 18 received a permanent implant. All subjects had the leads placed anatomically without the need for paresthesia. Subjects experienced significant and sustained pain relief (at least 65% at all timepoints) whereas physicians noted improvements in neurological function. Significant improvements in disability, function, sleep, sensory, and affective dimensions of pain were reported at all timepoints. All adverse events were resolved without sequelae.
CONCLUSION


Findings from this study suggest that 10 kHz SCS may provide sustained pain relief and disability improvements in patients suffering from PPN.",2021,Subjects experienced significant and sustained pain relief (at least 65% at all timepoints) while physicians noted improvements in neurological function.,"['Chronic Peripheral Polyneuropathy (PPN', 'Subjects underwent trial stimulation utilizing two epidural leads, and if successful were implanted with a', 'Twenty-one of the 26 trialed subjects had a successful trial and 18 received a', 'Clinically diagnosed PPN subjects refractory to conventional medical management were enrolled in this prospective, multi-center study between November 2015 and August 2016, after institutional review board approval and patient informed consent were obtained', 'patients suffering from PPN', 'patients with peripheral polyneuropathy (PPN']","['permanent implant', 'permanent 10 kHz SCS system', 'kHz SCS', '10 kHz Spinal Cord Stimulation (SCS']","['disability, function, sleep, sensory and affective dimensions of pain', 'sustained pain relief', 'adverse events, pain, neurological assessments, disability, function, quality of life, pain interference, sleep, satisfaction, and global impression of change', 'neurological function', 'pain relief and disability improvements']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1631603', 'cui_str': 'Patient notified'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1286323', 'cui_str': 'Affective dimension of pain'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",,0.0395655,Subjects experienced significant and sustained pain relief (at least 65% at all timepoints) while physicians noted improvements in neurological function.,"[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Galan', 'Affiliation': 'Georgia Pain Care, Stockbridge, Georgia, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Scowcroft', 'Affiliation': ""KC Pain Centers, Lee's Summit, Missouri, USA.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chang', 'Affiliation': 'Georgia Pain Care, Stockbridge, Georgia, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Premier Pain Centers, Shrewsbury, New Jersey, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Staats', 'Affiliation': 'Premier Pain Centers, Shrewsbury, New Jersey, USA.'}, {'ForeName': 'Jeyakumar', 'Initials': 'J', 'LastName': 'Subbaroyan', 'Affiliation': 'Nevro Corp, Redwood City, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Caraway', 'Affiliation': 'Nevro Corp, Redwood City, California, USA.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.13059']
842,34254980,Preventing depression in older people with multimorbidity: 24-month follow-up of a trial of internet-delivered cognitive behaviour therapy.,"BACKGROUND


older people coping with the impacts of living with multimorbidity are at increased risk of developing a depressive disorder.
OBJECTIVE


this article reports the 24-month results of a randomised controlled trial of an internet-delivered cognitive behaviour therapy, which aimed to test whether depressive disorders could be prevented in this population.
PARTICIPANTS


community-based participants aged 65 years and over, who had two or more chronic physical health conditions and were assessed as having no current depressive disorder.
METHODS


in total, 302 participants were randomised to an 8-week, five-lesson, internet-delivered intervention program (n = 150) or treatment as usual (TAU, n = 152). The primary outcomes were cases of depressive disorder, assessed post-intervention and at 3-month intervals throughout the trial, and depressive symptoms, assessed at pre-intervention, post-intervention, 6, 12 and 24 months following the intervention.
RESULTS


there were significantly fewer cases of depressive disorder in the intervention group (n = 23, 15%) compared with the TAU group (n = 41, 27%) during the 24 months after the intervention (χ2(1, N = 302) = 6.13, P = 0.013, odds ratio = 0.490 [95% confidence interval: 0.277, 0.867]), representing a 44% reduction in cases of depressive disorder. No differences were found on depressive symptoms at 24-month follow-up. Internet-delivered cognitive behaviour therapy had high engagement and acceptability.
CONCLUSIONS


the results provide support that depressive disorders can be prevented in older people with multimorbidity through participation in internet-delivered cognitive behaviour therapy. With access to internet-delivered interventions in clinical care settings increasing, this has implications for older patient care where multimorbidity is extremely common.",2021,No differences were found on depressive symptoms at 24-month follow-up.,"['302 participants', 'older people with multimorbidity', 'community-based participants aged 65\xa0years and over, who had two or more chronic physical health conditions and were assessed as having no current depressive disorder', 'in total']","['internet-delivered cognitive behaviour therapy', 'internet-delivered intervention program', 'Internet-delivered cognitive behaviour therapy']","['depressive symptoms', 'cases of depressive disorder, assessed post-intervention and at 3-month intervals throughout the trial, and depressive symptoms', 'depressive disorder']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",302.0,0.0642697,No differences were found on depressive symptoms at 24-month follow-up.,"[{'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Read', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Sharpe', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Burton', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Areán', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McDonald', 'Affiliation': 'Department of Psychology, Macquarie Unversity, Sydney, Australia.'}, {'ForeName': 'Nickolai', 'Initials': 'N', 'LastName': 'Titov', 'Affiliation': 'Department of Psychology, Macquarie Unversity, Sydney, Australia.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Gandy', 'Affiliation': 'Department of Psychology, Macquarie Unversity, Sydney, Australia.'}, {'ForeName': 'Blake F', 'Initials': 'BF', 'LastName': 'Dear', 'Affiliation': 'Department of Psychology, Macquarie Unversity, Sydney, Australia.'}]",Age and ageing,['10.1093/ageing/afab145']
843,34254189,Dose-dependent effects of insoluble fibre on glucose metabolism: a stratified post hoc analysis of the Optimal Fibre Trial (OptiFiT).,"AIMS


As the first long-term RCT on insoluble cereal fibre, the optimal fibre trial demonstrated glycometabolic benefits, confirming cohort studies. The combined study intervention of lifestyle recommendations and supplementation with insoluble oat hulls fibre allows to clarify, which amount of fibre is required for a beneficial effect.
METHODS


One hundred and eighty participants with impaired glucose tolerance underwent the one-year PREDIAS lifestyle programme and received a blinded, randomized fibre or placebo supplement for two years. We conducted a regression analyses and cut-off-based tertile comparisons in subjects with full data on dietary compliance (food records and accounted supplement; n = 120) after one year, investigating effects on fasting blood parameters, oral glucose tolerance test and anthropometry.
RESULTS


We found a nonlinear inverse relation between fibre intake and change in postprandial 2-h glucose levels, showing a metabolic benefit beyond 14 g and a plateau beyond 25 g of total insoluble fibre per day. 2-h glucose levels improved significantly stronger in both upper tertiles (-0.9 [-1.6;-0.2] mmol/l, p = 0.047, and -0.6 [-1.6;0.3] mmol/l, p = 0.010) compared to the lowest tertile (0.1 [-1.2;1.1] mmol/l), also when adjusted for changes in bodyweight. Subjects with the highest fibre intake showed superior effects on fasting and postprandial insulin resistance, hepatic insulin clearance, leucocyte count and fatty liver index.
CONCLUSIONS


Extending the knowledge on the benefits of insoluble oat hulls fibre, our post hoc analysis demonstrates a dose effect for glycaemia and associated metabolic markers. Further research is needed in order to replicate our findings in larger trials.",2021,"Subjects with the highest fibre intake showed superior effects on fasting and postprandial insulin resistance, hepatic insulin clearance, leucocyte count and fatty liver index.
","['subjects with full data on dietary compliance (food records and accounted supplement; n\u2009=\u2009120) after one year', 'One hundred and eighty participants with impaired glucose tolerance underwent the one-year PREDIAS lifestyle programme']",['placebo'],"['glucose metabolism', 'postprandial 2-h glucose levels', 'fasting blood parameters, oral glucose tolerance test and anthropometry', 'fasting and postprandial insulin resistance, hepatic insulin clearance, leucocyte count and fatty liver index', '2-h glucose levels']","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",180.0,0.0669459,"Subjects with the highest fibre intake showed superior effects on fasting and postprandial insulin resistance, hepatic insulin clearance, leucocyte count and fatty liver index.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kabisch', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Campus Benjamin Franklin, Charité University Medicine, Hindenburgdamm 30, 12203, Berlin, Germany. Stefan.kabisch@charite.de.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Honsek', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke, Arthur-Scheunert-Allee 114-116, 14558, Nuthetal, Germany.'}, {'ForeName': 'Margrit', 'Initials': 'M', 'LastName': 'Kemper', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Campus Benjamin Franklin, Charité University Medicine, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Gerbracht', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Campus Benjamin Franklin, Charité University Medicine, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Ayman M', 'Initials': 'AM', 'LastName': 'Arafat', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Campus Benjamin Franklin, Charité University Medicine, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Birkenfeld', 'Affiliation': 'Deutsches Zentrum Für Diabetesforschung E.V., Geschäftsstelle Am Helmholtz-Zentrum München, Ingolstädter Landstraße 1, 85764, Neuherberg, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Dambeck', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke, Arthur-Scheunert-Allee 114-116, 14558, Nuthetal, Germany.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Osterhoff', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Campus Benjamin Franklin, Charité University Medicine, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Martin O', 'Initials': 'MO', 'LastName': 'Weickert', 'Affiliation': 'Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism, The ARDEN NET Centre, ENETS CoE, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, CV2 2DX, UK.'}, {'ForeName': 'Andreas F H', 'Initials': 'AFH', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Campus Benjamin Franklin, Charité University Medicine, Hindenburgdamm 30, 12203, Berlin, Germany.'}]",Acta diabetologica,['10.1007/s00592-021-01772-0']
844,34256964,"Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers.","PURPOSE


A new sustained-release (SR) pregabalin formulation (YHD1119) designed for once-daily dosing has recently been developed to improve patient adherence. This study aimed to compare the pharmacokinetics of pregabalin SR and immediate-release (IR) formulations after multiple oral doses and to assess the effect of food on the pharmacokinetic profile of the pregabalin SR formulation after a single dose in healthy individuals.
METHODS


Two clinical trials were conducted: a randomized, open-label, multiple-dose, 2-treatment, 2-period crossover study to evaluate the steady-state pharmacokinetic properties of SR treatment (pregabalin SR 300 mg once daily for 3 days) and IR treatment (pregabalin IR 150 mg twice daily for 3 days) under fed conditions and a randomized, open-label, single-dose, 2-treatment, 2-period, crossover study to evaluate the effect of food intake on the pharmacokinetic properties of the pregabalin SR formulation. Plasma concentrations of pregabalin were measured using LC-MS/MS. The AUC and C max  for pregabalin were calculated using noncompartmental method and compared between treatments in each study.
FINDINGS


Thirty-one individuals in the bioequivalence study and 23 in the food effect study completed the pharmacokinetic sampling. The geometric mean ratios of C max,ss  and AUC 0-τ  between the SR and IR formulations were 1.1642 (90% CI, 1.1043-1.2272) and 0.9704 (90% CI, 0.9372-1.0047), respectively. The geometric mean ratios of C max  and AUC 0-last  between the SR formulation in the fed state and in the fasted state were 1.6514 (90% CI, 1.3820-1.9732) and 1.7899 (90%CI, 1.4499-2.2097), respectively.
IMPLICATIONS


The bioavailability of the pregabalin SR 300 mg formulation is increased if taken with a high-fat meal. Once-daily pregabalin SR 300 mg is bioequivalent to twice-daily pregabalin IR 150 mg under fed conditions at steady state. The pregabalin SR formulation is expected to improve patient adherence. ClinicalTrials.gov identifiers: NCT02783183 (bioequivalence study) and NCT03191136 (food effect study).",2021,"The geometric mean ratios of C max,ss  and AUC 0-τ  between the SR and IR formulations were 1.1642 (90% CI, 1.1043-1.2272) and 0.9704 (90% CI, 0.9372-1.0047), respectively.","['Thirty-one individuals in the bioequivalence study and 23 in the food effect study completed the pharmacokinetic sampling', 'Healthy Male Volunteers', 'healthy individuals']","['pregabalin SR and immediate-release (IR) formulations', 'SR treatment (pregabalin SR 300 mg once daily for 3 days) and IR treatment (pregabalin IR', 'pregabalin SR formulation', 'pregabalin SR', 'New, Once-Daily, Sustained-Release Pregabalin Tablet']","['Plasma concentrations of pregabalin', 'bioavailability', 'geometric mean ratios of C max  and AUC 0-last', 'geometric mean ratios of C max,ss  and AUC 0-τ  between the SR and IR formulations', 'AUC and C max  for pregabalin']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]",,0.0274348,"The geometric mean ratios of C max,ss  and AUC 0-τ  between the SR and IR formulations were 1.1642 (90% CI, 1.1043-1.2272) and 0.9704 (90% CI, 0.9372-1.0047), respectively.","[{'ForeName': 'Seol Ju', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Yeji', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Clinical Development Department, R&D Division, Yuhan Corporation, Seoul, Republic of Korea.'}, {'ForeName': 'Taewon', 'Initials': 'T', 'LastName': 'An', 'Affiliation': 'Clinical Development Department, R&D Division, Yuhan Corporation, Seoul, Republic of Korea.'}, {'ForeName': 'Seong Bok', 'Initials': 'SB', 'LastName': 'Jang', 'Affiliation': 'Clinical Development Department, R&D Division, Yuhan Corporation, Seoul, Republic of Korea.'}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Clinical Development Department, R&D Division, Yuhan Corporation, Seoul, Republic of Korea.'}, {'ForeName': 'Woon-Sook', 'Initials': 'WS', 'LastName': 'Na', 'Affiliation': 'Business & New Product Development Department, R&D Division, Yuhan Corporation, Seoul, Republic of Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Jeonbuk National University Medical School, Jeonju, Republic of Korea; Research Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Min-Gul', 'Initials': 'MG', 'LastName': 'Kim', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju, Republic of Korea; Research Institute of Clinical Medicine of Jeonbuk National University, Jeonju, Republic of Korea; Department of Pharmacology, School of Medicine, Jeonbuk National University, Jeonju, Republic of Korea. Electronic address: mgkim@jbnu.ac.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2021.06.010']
845,34256031,"Effect of tezepelumab on airway inflammatory cells, remodelling, and hyperresponsiveness in patients with moderate-to-severe uncontrolled asthma (CASCADE): a double-blind, randomised, placebo-controlled, phase 2 trial.","BACKGROUND


Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin (TSLP), an epithelial cell-derived cytokine. In phase 2b and 3 studies, tezepelumab significantly reduced exacerbations versus placebo in patients with severe uncontrolled asthma, irrespective of baseline levels of type 2 inflammatory biomarkers. We investigated the mechanism of action of tezepelumab by assessing its effects on airway inflammatory cells, airway remodelling, and airway hyperresponsiveness.
METHODS


CASCADE was an exploratory, double-blind, randomised, placebo-controlled, parallel-group, phase 2 study done in 27 medical centres in Canada, Denmark, Germany, the UK, and the USA. Adults aged 18-75 years with uncontrolled, moderate-to-severe asthma were randomly assigned (1:1) to receive tezepelumab 210 mg or placebo administered subcutaneously every 4 weeks for a planned 28 weeks, extended to up to 52 weeks if COVID-19-related disruption delayed participants' end-of-treatment assessments. Randomisation was balanced and stratified by blood eosinophil count. The primary endpoint was the change from baseline to the end of treatment in the number of airway submucosal inflammatory cells in bronchoscopic biopsy samples. Eosinophils, neutrophils, CD3 +  T cells, CD4 +  T cells, tryptase +  mast cells, and chymase +  mast cells were evaluated separately. This endpoint was also assessed in subgroups according to baseline type 2 inflammatory biomarker levels, including blood eosinophil count. Airway remodelling was assessed via the secondary endpoints of change from baseline in reticular basement membrane thickness and epithelial integrity (proportions of denuded, damaged, and intact epithelium). Exploratory outcomes included airway hyperresponsiveness to mannitol. All participants who completed at least 20 weeks of study treatment, had an end-of-treatment visit up to 8 weeks after the last dose of study drug, and had evaluable baseline and end-of-treatment bronchoscopies were included in the primary efficacy analysis. All participants who received at least one dose of study drug were included in the safety analyses. This study is registered with ClinicalTrials.gov, NCT03688074.
FINDINGS


Between Nov 2, 2018, and Nov 16, 2020, 250 patients were enrolled, 116 of whom were randomly assigned (59 to tezepelumab, 57 to placebo). 48 in the tezepelumab group and 51 in the placebo group completed the study and were assessed for the primary endpoint. Treatment with tezepelumab resulted in a nominally significantly greater reduction from baseline to the end of treatment in airway submucosal eosinophils versus placebo (ratio of geometric least-squares means 0·15 [95% CI 0·05-0·41]; nominal p<0·0010), with the difference seen across all baseline biomarker subgroups. There were no significant differences between treatment groups in the other cell types evaluated (ratio of geometric least-squares means: neutrophils 1·36 [95% CI 0·94-1·97]; CD3 +  T cells 1·12 [0·86-1·46]; CD4 +  T cells 1·18 [0·90-1·55]; tryptase +  mast cells 0·83 [0·61-1·15]; chymase +  mast cells 1·19 [0·67-2·10]; all p>0·10). In assessment of secondary endpoints, there were no significant differences between treatment groups in reticular basement membrane thickness and epithelial integrity. In an exploratory analysis, the reduction in airway hyperresponsiveness to mannitol was significantly greater with tezepelumab versus placebo (least-squares mean change from baseline in interpolated or extrapolated provoking dose of mannitol required to induce ≥15% reduction in FEV 1  from baseline: tezepelumab 197·4 mg [95% CI 107·9 to 286·9]; placebo 58·6 mg [-30·1 to 147·33]; difference 138·8 [14·2 to 263·3], nominal p=0·030). Adverse events were reported in 53 (90%) patients in the tezepelumab group and 51 (90%) patients in the placebo group, and there were no safety findings of concern.
INTERPRETATION


The improvements in asthma clinical outcomes observed in previous studies with tezepelumab are probably driven, at least in part, by reductions in eosinophilic airway inflammation, as shown here by reduced airway eosinophil counts regardless of baseline blood eosinophil count. Tezepelumab also reduced airway hyperresponsiveness to mannitol, indicating that TSLP blockade might have additional benefits in asthma beyond reducing type 2 airway inflammation.
FUNDING


AstraZeneca and Amgen.",2021,"In assessment of secondary endpoints, there were no significant differences between treatment groups in reticular basement membrane thickness and epithelial integrity.","['All participants who received at least one dose of study drug were included in the safety analyses', '0·83', 'patients with severe uncontrolled asthma', '250 patients were enrolled, 116 of whom were randomly assigned (59 to', 'neutrophils 1·36', 'patients with moderate-to-severe uncontrolled asthma (CASCADE', 'Between Nov 2, 2018, and Nov 16, 2020', 'Adults aged 18-75 years with uncontrolled, moderate-to-severe asthma', 'All participants who completed at least 20 weeks of study treatment, had an end-of-treatment visit up to 8 weeks after the last dose of study drug, and had evaluable baseline and end-of-treatment bronchoscopies', '27 medical centres in Canada, Denmark, Germany, the UK, and the USA', '1·12']","['tezepelumab versus placebo', 'tezepelumab, 57 to placebo', 'Tezepelumab', 'CD3 +  T cells', 'placebo', 'tezepelumab', 'tezepelumab 210 mg or placebo']","['reticular basement membrane thickness and epithelial integrity', 'eosinophilic airway inflammation', 'tryptase +  mast cells', 'airway hyperresponsiveness to mannitol', 'airway inflammatory cells, remodelling, and hyperresponsiveness', 'blood eosinophil count', 'Adverse events', 'number of airway submucosal inflammatory cells', 'Eosinophils, neutrophils, CD3 +  T cells, CD4 +  T cells, tryptase +  mast cells, and chymase +  mast cells', 'epithelial integrity (proportions of denuded, damaged, and intact epithelium', 'airway submucosal eosinophils']","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0439739', 'cui_str': 'Reticular'}, {'cui': 'C0004799', 'cui_str': 'Basement membrane'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0147080', 'cui_str': 'Tryptase'}, {'cui': 'C0024880', 'cui_str': 'Mast cell'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0055673', 'cui_str': 'Chymase'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}]",250.0,0.765091,"In assessment of secondary endpoints, there were no significant differences between treatment groups in reticular basement membrane thickness and epithelial integrity.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Diver', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Department of Respiratory Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Latifa', 'Initials': 'L', 'LastName': 'Khalfaoui', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Department of Respiratory Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Emson', 'Affiliation': 'Translational Science and Experimental Medicine, Research and Early Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Wenzel', 'Affiliation': 'University of Pittsburgh Asthma Institute, Pittsburgh, PA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Menzies-Gow', 'Affiliation': 'Department of Respiratory Medicine, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Johnston', 'Affiliation': 'Biometrics, Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Nestor', 'Initials': 'N', 'LastName': 'Molfino', 'Affiliation': 'Global Development, Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Parnes', 'Affiliation': 'Translational Medicine, Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Megally', 'Affiliation': 'Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Colice', 'Affiliation': 'Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Brightling', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Department of Respiratory Sciences, University of Leicester, Leicester, UK. Electronic address: ceb17@leicester.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00226-5']
846,34263971,"Licogliflozin versus placebo in women with polycystic ovary syndrome: A randomized, double-blind, phase 2 trial.","Polycystic ovary syndrome (PCOS) is characterized by hyperandrogenism and insulin resistance. The dual sodium-glucose co-transporter 1/2 inhibitor (SGLT1/2i) licogliflozin (LIK066) ameliorates hyperinsulinism in patients with diabetes and obesity. This study examines the effect of licogliflozin on androgens in women with PCOS. In a multicentre, randomized, placebo-controlled, double-blind, 2-week trial, patients with PCOS received licogliflozin 50 mg or placebo three times a day (TID). Changes in free testosterone (FT), other androgens and variables of insulin resistance were analysed. Concentration of FT did not change (TR LIK066  :TR PCB  [FT]: 0.88; 90% CI: 0.70-1.11; P = .353). Licogliflozin reduced androstendione (A4) by 19% (TR LIK066  :TR PCB  [A4]: 0.81; 90% CI: 0.68-0.99; P = .089) and dehydroepiandrosteron sulphate (DHEAS) by 24% (TR LIK066  :TR PCB  [DHEAS]: 0.76; 90% CI: 0.65-0.89; P = .008). Hyperinsulinaemia was reduced by 70% by licogliflozin (highest insulin concentration [MAXI]; TR LIK066  :TR PCB  [MAXI]: 0·26; 90% CI:0.20-0.34; P < .001 and area under the curve insulin [AUCI]; TR LIK066  :TR PCB  [AUCI]: 0.32; 90% CI: 0.25-0.41; P < .001). Diarrhoea and nausea occurred as common adverse events. Dual inhibition of SGLT1/2 ameliorates hyperinsulinaemia and hyperandrogenaemia in women with PCOS. Licogliflozin may represent a promising novel treatment option for PCOS.",2021,Hyperinsulinaemia was reduced by 70% by licogliflozin (highest insulin concentration (MAXI);,"['women with polycystic ovary syndrome (PCOS', '0·32', 'patients with diabetes and obesity', '0·88', 'women with PCOS']","['dual sodium-glucose transporter 1/2 inhibitor (SGLT1/2i) licogliflozin (LIK066', 'Licogliflozin', 'placebo', ' 90%CI', 'Licogliflozin versus placebo', 'licogliflozin 50\u2009mg or placebo TID', 'licogliflozin', 'TR PCB  (MAXI']","['Diarrhea and nausea', 'TR PCB  (FT', 'Hyperinsulinaemia', 'insulin concentration (MAXI', 'TR PCB  (DHEAS', 'TR PCB  (AUCI', 'free testosterone (FT), other androgens and parameters of insulin resistance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032447', 'cui_str': 'Polychlorinated biphenyl'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0032447', 'cui_str': 'Polychlorinated biphenyl'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.44126,Hyperinsulinaemia was reduced by 70% by licogliflozin (highest insulin concentration (MAXI);,"[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Ignatenko', 'Affiliation': 'Charité Research Organisation GmbH, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wagner', 'Affiliation': 'Charité Research Organisation GmbH, Berlin, Germany.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Dokras', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Seufert', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Zwanziger', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Dunschen', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Zakaria', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Huseinovic', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Craig T', 'Initials': 'CT', 'LastName': 'Basson', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Mahling', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Fuhrer', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hinder', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Basel, Switzerland.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14495']
847,34267085,The Impact of Optimism and Pain Interference on Response to Online Behavioral Treatment for Mood and Anxiety Symptoms.,"OBJECTIVE


This study aimed to explore a) if high pain interference has a negative effect on response to computerized cognitive behavioral therapy (cCBT) for anxiety and depression and b) whether high optimism can buffer the negative effects of pain interference on cCBT outcomes.
METHODS


We performed a secondary analysis of data on 403 participants from the randomized controlled clinical trial ""Online Treatment for Mood and Anxiety Disorders in Primary Care."" It examined the impact of cCBT, with and without access to an Internet support group, on health-related quality of life (HRQoL), mood, and anxiety symptoms.
RESULTS


High versus low pain interference had a negative effect on response to cCBT for physical HRQoL regardless of high or low optimism level (between group difference = -3.46 [-5.89 to -1.03], p = .005, or -4.06 [-6.28 to -1.85], p < .001, respectively). However, in the context of low optimism/high pain interference only negatively impacted the effect of cCBT on mental HRQoL (3.68 [0.63 to 6.73], p = .018) and anxiety symptoms (-2.61 [-4.87 to -0.35], p = .024). Although the pattern of effects was similar for depressive symptoms, the between-group differences were not significant.
CONCLUSIONS


High optimism may buffer against the negative effects of pain interference on treatment response from cCBT. Primary care patients who report high pain interference yet also lack optimism may not receive as much benefit from cCBT as other groups. Furthermore, this study found an unexpected positive effect of low optimism on treatment response. For depressed and anxious patients with low pain interference, low optimism enhanced the impact of cCBT on mental HRQoL.Trial Registration:ClinicalTrials.gov Identifier: NCT01482806.",2021,"However, in the context of low optimism high pain interference only negatively impacted the effect of cCBT on mental HRQoL (3.68 (0.63, 6.73) p = 0.018) and anxiety symptoms (-2.61 (-4.87, -0.35) p = 0.024).","['403 participants from the randomized controlled clinical trial ""Online Treatment for Mood and Anxiety Disorders in Primary Care']",['computerized cognitive behavioral therapy (cCBT'],"['mental HRQoL', 'anxiety symptoms', 'health-related quality of life (HRQoL), mood, and anxiety symptoms', 'Mood and Anxiety Symptoms', 'depressive symptoms']","[{'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",403.0,0.0327649,"However, in the context of low optimism high pain interference only negatively impacted the effect of cCBT on mental HRQoL (3.68 (0.63, 6.73) p = 0.018) and anxiety symptoms (-2.61 (-4.87, -0.35) p = 0.024).","[{'ForeName': 'Natalia E', 'Initials': 'NE', 'LastName': 'Morone', 'Affiliation': 'From the Section of General Internal Medicine (Morone), Boston University School of Medicine, Boston Medical Center, Boston, Massachusetts; University of Pittsburgh Center for Behavioral Health, Media, and Technology, Division of General Internal Medicine (Belnap Herbeck, Rollman, Jonassaint), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Department of Psychosomatic Medicine and Psychotherapy (Belnap Herbeck), University of Göttingen Medical Center, Göttingen, Germany; and Division of General Internal Medicine (Huang, Abebe), and Center for Research on Health Care Data Center, Division of General Internal Medicine (Abebe), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Bea Belnap', 'Initials': 'BB', 'LastName': 'Herbeck', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': ''}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Rollman', 'Affiliation': ''}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Jonassaint', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000980']
848,34269427,Management of work stress in science education lecturers' population using rational emotive occupational health coaching: Implication for educational evaluators.,"INTRODUCTION


Nigerian university lecturers face a lot of works in the day-to-day discharge of their responsibilities as academics. This constitutes a lot of stress for them as documented in the literature. However, literature is scarce on how these lecturers manage their work stress. Thus, the researchers explored the efficacy of rational emotive occupational health coaching (REOHC) on the management of work stress among lecturers.
METHOD


A randomised controlled trial group experimental research design was adopted using a sample size of 84 lecturers in Science Education Departments of the sampled universities. An occupational stress index was used in the gathering of necessary data for the study. The REOHC treatment lasted for 12 weeks after which the participants were posttested and a follow-up measure followed after 3 months of the termination of the treatment. Repeated measures analysis of variance statistical approach was used to analyse the obtained data.
RESULTS


It was revealed that REOHC was significantly (p < 0.05) effective in the management of work stress in a population of science education lecturers in Nigeria.
CONCLUSION


REOHC enables science education lecturers to effectively manage their work stress to maximise their work outputs. This finding implicates the expertise of Educational Evaluators.",2021,"It was revealed that REOHC was significantly (p < 0.05) effective in the management of work stress in a population of science education lecturers in Nigeria.
",['sample size of 84 lecturers in Science Education Departments of the sampled universities'],['rational emotive occupational health coaching (REOHC'],[],"[{'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0079920', 'cui_str': 'Occupational Health'}]",[],,0.0449947,"It was revealed that REOHC was significantly (p < 0.05) effective in the management of work stress in a population of science education lecturers in Nigeria.
","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Ugwuanyi', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Chinedu I O', 'Initials': 'CIO', 'LastName': 'Okeke', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Uchechukwu H', 'Initials': 'UH', 'LastName': 'Ekwueme', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, Nigeria.'}]",Journal of community psychology,['10.1002/jcop.22667']
849,34269423,Estimating cardiorespiratory fitness in older adults using a usual-paced 400-m long-distance corridor walk.,,2021,,['older adults using a usual-paced 400-m long-distance corridor walk'],[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0557670', 'cui_str': 'Corridor'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",[],[],,0.0615927,,"[{'ForeName': 'Reagan E', 'Initials': 'RE', 'LastName': 'Moffit', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Yujia Susanna', 'Initials': 'YS', 'LastName': 'Qiao', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Moored', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Santanasto', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Brittney S', 'Initials': 'BS', 'LastName': 'Lange-Maia', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois, USA.""}, {'ForeName': 'Peggy M', 'Initials': 'PM', 'LastName': 'Cawthon', 'Affiliation': 'Translational Research Institute, AdventHealth Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Bret H', 'Initials': 'BH', 'LastName': 'Goodpaster', 'Affiliation': 'Research Institute, California Pacific Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Elsa S', 'Initials': 'ES', 'LastName': 'Strotmeyer', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Nancy W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.17360']
850,34274687,Feasibility and effectiveness of interactive stepping exercise on community-dwelling older adults: A pilot randomized controlled trial.,"Recently, the interactive stepping exercise (ISE) was developed on the basis of square stepping exercise. The aim of this study was to examine the feasibility and effectiveness of ISE on executive function and gait variability among community-dwelling older adults. Fourteen participants were recruited and randomly assigned to the experimental group (n=7) or control group (n=7) and received ISE or home exercise program, respectively, three times a week for 12 weeks. The outcomes included retention rate, attendance rate, Trail Making Test, and dual-task walking. The results showed that participants had high retention and attendance rate for the ISE intervention. Moreover, significant improvement in the part A of Trail Making Test and stride length variability during cognitive dual-task walking after 12-week ISE intervention. The current results suggested that ISE is a feasible and effective intervention on executive function and gait variability in community-dwelling older adults.",2021,"Moreover, significant improvement in the part A of Trail Making Test and stride length variability during cognitive dual-task walking after 12-week ISE intervention.","['community-dwelling older adults', 'Fourteen participants']","['interactive stepping exercise (ISE', 'interactive stepping exercise', 'ISE or home exercise program', 'ISE']","['high retention and attendance rate', 'executive function and gait variability', 'Trail Making Test and stride length variability during cognitive dual-task walking', 'retention rate, attendance rate, Trail Making Test, and dual-task walking']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}]",14.0,0.0214301,"Moreover, significant improvement in the part A of Trail Making Test and stride length variability during cognitive dual-task walking after 12-week ISE intervention.","[{'ForeName': 'Li-Chin', 'Initials': 'LC', 'LastName': 'Sow', 'Affiliation': ""Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan; Department of Rehabilitation, St Luke's ElderCare Changkat Centre, Singapore.""}, {'ForeName': 'Hsin-Hsuan', 'Initials': 'HH', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ray-Yau', 'Initials': 'RY', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shun-Hwa', 'Initials': 'SH', 'LastName': 'Wei', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Kuan', 'Initials': 'HK', 'LastName': 'Wu', 'Affiliation': 'Makerspace, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Yea-Ru', 'Initials': 'YR', 'LastName': 'Yang', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan; Preventive Medicine Research Center, National Yang-Ming University, Taipei, Taiwan. Electronic address: yryang@nycu.edu.tw.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.06.021']
851,34280820,Exercise-induced increases in Anandamide and BDNF during extinction consolidation contribute to reduced threat following reinstatement: Preliminary evidence from a randomized controlled trial.,"INTRODUCTION


We recently demonstrated that moderate-intensity aerobic exercise delivered during the consolidation of fear extinction learning reduced threat expectancy during a test of extinction recall among women with posttraumatic stress disorder (PTSD). These findings suggest that exercise may be a potential candidate for improving the efficacy of exposure-based therapies, which are hypothesized to work via the mechanisms of fear extinction learning. The purpose of this secondary analysis was to examine whether exercise-induced increases in circulating concentrations of candidate biomarkers: endocannabinoids (anandamide [AEA]; 2-arachidonoylglycerol [2-AG], brain-derived neurotrophic factor (BDNF), and homovanillic acid (HVA), mediate the effects of exercise on extinction recall.
METHODS


Participants (N = 35) completed a 3-day fear acquisition (day 1), extinction (day 2), and extinction recall (day 3) protocol, in which participants were randomly assigned to complete either moderate-intensity aerobic exercise (EX) or a light-intensity control (CON) condition following extinction training (day 2). Blood was obtained prior to and following EX or CON. Threat expectancy ratings during tests of extinction recall (i.e., initial fear recall and fear recall following reinstatement) were obtained 24 h following EX or CON. Mediation was tested using linear-mixed effects models and bootstrapping of the indirect effect.
RESULTS


Circulating concentrations of AEA and BDNF (but not 2-AG and HVA) were found to mediate the relationship between moderate-intensity aerobic exercise and reduced threat expectancy ratings following reinstatement (AEA 95% CI: -0.623 to -0.005; BDNF 95% CI: -0.941 to -0.005).
CONCLUSIONS


Exercise-induced increases in peripheral AEA and BDNF appear to play a role in enhancing consolidation of fear extinction learning, thereby leading to reduced threat expectancies following reinstatement among women with PTSD. Future mechanistic research examining these and other biomarkers (e.g., brain-based biomarkers) is warranted.",2021,"Threat expectancy ratings during tests of extinction recall (i.e., initial fear recall and fear recall following reinstatement) were obtained 24 h following EX or CON.","['Participants (N\xa0=\xa035) completed a', 'women with PTSD', 'women with posttraumatic stress disorder (PTSD']","['moderate-intensity aerobic exercise (EX) or a light-intensity control (CON) condition following extinction training', '3-day fear acquisition (day 1), extinction (day 2), and extinction recall (day 3) protocol']","['threat expectancy ratings', 'peripheral AEA and BDNF', 'circulating concentrations of candidate biomarkers: endocannabinoids (anandamide [AEA]; 2-arachidonoylglycerol [2-AG], brain-derived neurotrophic factor (BDNF), and homovanillic acid (HVA', 'extinction recall (i.e., initial fear recall and fear recall following reinstatement', 'Anandamide and BDNF']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C0299477', 'cui_str': 'glyceryl 2-arachidonate'}, {'cui': 'C0019903', 'cui_str': 'Homovanillic acid'}, {'cui': 'C0178681', 'cui_str': 'Homovanillate'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]",,0.0384587,"Threat expectancy ratings during tests of extinction recall (i.e., initial fear recall and fear recall following reinstatement) were obtained 24 h following EX or CON.","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Crombie', 'Affiliation': 'University of Wisconsin, Department of Psychiatry, 6001 Research Park Boulevard, Madison, WI 53719-1176, United States. Electronic address: kmcrombie@wisc.edu.'}, {'ForeName': 'Anneliis', 'Initials': 'A', 'LastName': 'Sartin-Tarm', 'Affiliation': 'University of Wisconsin, Department of Psychiatry, 6001 Research Park Boulevard, Madison, WI 53719-1176, United States.'}, {'ForeName': 'Kyrie', 'Initials': 'K', 'LastName': 'Sellnow', 'Affiliation': 'University of Wisconsin, Department of Psychiatry, 6001 Research Park Boulevard, Madison, WI 53719-1176, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ahrenholtz', 'Affiliation': 'University of Wisconsin, Department of Psychiatry, 6001 Research Park Boulevard, Madison, WI 53719-1176, United States.'}, {'ForeName': 'Sierra', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'University of Wisconsin, Department of Psychiatry, 6001 Research Park Boulevard, Madison, WI 53719-1176, United States.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Matalamaki', 'Affiliation': 'University of Wisconsin, Department of Psychiatry, 6001 Research Park Boulevard, Madison, WI 53719-1176, United States.'}, {'ForeName': 'Neda E', 'Initials': 'NE', 'LastName': 'Almassi', 'Affiliation': 'University of Wisconsin, Department of Kinesiology, 285 Med Sci, 1300 University Ave, Madison, WI 53706-1121, United States.'}, {'ForeName': 'Cecilia J', 'Initials': 'CJ', 'LastName': 'Hillard', 'Affiliation': 'Medical College of Wisconsin, Neuroscience Research Center, Department of Pharmacology and Toxicology, 8701 Watertown Plank Rd., Milwaukee, WI 53226, United States.'}, {'ForeName': 'Kelli F', 'Initials': 'KF', 'LastName': 'Koltyn', 'Affiliation': 'University of Wisconsin, Department of Kinesiology, 285 Med Sci, 1300 University Ave, Madison, WI 53706-1121, United States.'}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Adams', 'Affiliation': 'University of Kentucky, Department of Psychology, 105 Kastle Hill, Lexington, KY 40506-0044, United States; Yale School of Medicine, Department of Psychiatry, 300 George St., New Haven, CT 06511, United States; National Center for PTSD, Clinical Neurosciences Division, VA CT Healthcare System, 950 Campbell Avenue, West Haven, CT 06516, United States.'}, {'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Cisler', 'Affiliation': 'University of Texas at Austin, Department of Psychiatry and Behavioral Sciences, 1601 Trinity St, Bldg B, Austin, TX 78712, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105355']
852,34281467,Metformin for diabetes prevention: update of the evidence base.,"We have conducted a narrative review based on a structured search strategy, focusing on the effects of metformin on the progression of non-diabetic hyperglycemia to clinical type 2 diabetes mellitus. The principal trials that demonstrated a significantly lower incidence of diabetes in at-risk populations randomized to metformin (mostly with impaired glucose tolerance [IGT]) were published mainly from 1999 to 2012. Metformin reduced the 3-year risk of diabetes by -31% in the randomized phase of the Diabetes Prevention Program (DPP),  vs.  -58% for intensive lifestyle intervention (ILI). Metformin was most effective in younger, heavier subjects. Diminishing but still significant reductions in diabetes risk for subjects originally randomized to these groups were present in the trial's epidemiological follow-up, the DPP Outcomes Study (DPPOS) at 10 years (-18 and -34%, respectively), 15 years (-18 and -27%), and 22 years (-18 and -25%). Long-term weight loss was also seen in both groups, with better maintenance under metformin. Subgroup analyses from the DPP/DPPOS have shed important light on the actions of metformin, including a greater effect in women with prior gestational diabetes, and a reduction in coronary artery calcium in men that might suggest a cardioprotective effect. Improvements in long-term clinical outcomes with metformin in people with non-diabetic hyperglycemia (""prediabetes"") have yet to be demonstrated, but cardiovascular and microvascular benefits were seen for those in the DPPOS who did not  vs.  did develop diabetes. Multiple health economic analyses suggest that either metformin or ILI is cost-effective in a community setting. Long-term diabetes prevention with metformin is feasible and is supported in influential guidelines for selected groups of subjects. Future research will demonstrate whether intervention with metformin in people with non-diabetic hyperglycemia will improve long-term clinical outcomes.",2021,"Diminishing but still significant reductions in diabetes risk for subjects originally randomised to these groups were present in the trial's epidemiological follow-up, the DPP Outcomes Study (DPPOS) at 10 years (-18% and -34%, respectively), 15 years (-18% and -27%) and 22 years (-18% and -25%).","['women with prior gestational diabetes', 'people with non-diabetic hyperglycaemia', 'people with non-diabetic hyperglycaemia (""prediabetes']","['metformin or ILI', 'metformin', 'Metformin']","['3-year risk of diabetes', 'diabetes risk', 'progression of non-diabetic hyperglycaemia', 'weight loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0850671', 'cui_str': 'Non-diabetic hyperglycemia'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0396670', 'cui_str': 'Isolated limb perfusion'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0850671', 'cui_str': 'Non-diabetic hyperglycemia'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0513486,"Diminishing but still significant reductions in diabetes risk for subjects originally randomised to these groups were present in the trial's epidemiological follow-up, the DPP Outcomes Study (DPPOS) at 10 years (-18% and -34%, respectively), 15 years (-18% and -27%) and 22 years (-18% and -25%).","[{'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hostalek', 'Affiliation': 'Global Medical Affairs, Merck Healthcare KGaA, Darmstadt, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Campbell', 'Affiliation': 'University of St Andrews, St Andrews, UK.'}]",Current medical research and opinion,['10.1080/03007995.2021.1955667']
853,34289338,Effect of Residual Retinal Fluid on Visual Function in Ranibizumab-Treated Neovascular Age-Related Macular Degeneration.,"PURPOSE


To investigate the relationship between retinal fluid and vision in ranibizumab-treated patients with neovascular age-related macular degeneration (nAMD).
DESIGN


Clinical cohort study using post hoc analysis of clinical trial data.
METHODS


We assessed data from HARBOR (NCT00891735), a phase III, randomized, controlled trial. We reviewed 917 patients ≥50 years of age with subfoveal nAMD associated with subretinal (SRF) and/or intraretinal fluid (IRF) at baseline, screening, or week 1. The intervention was intravitreal ranibizumab 0.5 or 2.0 mg (all treatment arms pooled). Outcomes included mean best-corrected visual acuity (BCVA) and BCVA change from baseline at months (M) 12 and 24 evaluated by the presence/absence of SRF and/or IRF.
RESULTS


Baseline BCVA was higher with residual vs resolved SRF at M12 (mean [95% confidence interval {CI}] 58.8 letters [57.2-60.4] vs 53.5 [52.4-54.5]) and M24 (59.3 letters [57.8-60.8] vs 53.5 [52.5-54.5]). Mean BCVA change (adjusted for baseline) to M12 was greater with residual vs resolved SRF (mean difference [95% CI], +2.4 letters [+0.1 to +4.7]), but lower with residual vs resolved IRF (-3.5 letters [-5.8 to -1.2]). Eyes with residual SRF (no IRF) exhibited the largest mean BCVA gains (M12, +14.1 letters; M24, +13.2 letters), followed by resolved SRF/IRF (M12, +10.6 letters; M24, +10.0 letters), residual SRF/IRF (M12, +7.2 letters; M24, +8.5 letters), and residual IRF only (M12, +5.5 letters; M24, +3.6 letters).
CONCLUSIONS


Vision outcomes (adjusted for baseline BCVA) through M24 were better in ranibizumab-treated eyes with residual vs resolved SRF, and worse with residual vs resolved IRF. Presence of residual retinal fluid requires a more complex and nuanced assessment and interpretation in the context of nAMD management.",2021,"Eyes with residual SRF (no IRF) exhibited the largest mean BCVA gains (M12, +14.1 letters; M24, +13.2), followed by resolved SRF/IRF (M12, +10.6 letters; M24, +10.0), residual SRF/IRF (M12, +7.2 letters; M24, +8.5), and residual IRF only (M12, +5.5 letters; M24, +3.6).
","['treated patients with neovascular age-related macular degeneration (nAMD', '917 patients aged ≥50 years with subfoveal nAMD associated with subretinal (SRF) and/or intraretinal fluid (IRF) at baseline, screening, or week 1', 'Treated Neovascular Age-Related Macular Degeneration']","['Intravitreal ranibizumab', 'Ranibizumab', 'IRF', 'Residual Retinal Fluid', 'ranibizumab']","['Mean BCVA change', 'Visual Function', 'mean BCVA gains', 'Mean best-corrected visual acuity (BCVA) and BCVA change', 'Baseline BCVA', 'residual SRF/IRF']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C5191378', 'cui_str': '917'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2699708', 'cui_str': 'Subretinal route'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}]",917.0,0.528685,"Eyes with residual SRF (no IRF) exhibited the largest mean BCVA gains (M12, +14.1 letters; M24, +13.2), followed by resolved SRF/IRF (M12, +10.6 letters; M24, +10.0), residual SRF/IRF (M12, +7.2 letters; M24, +8.5), and residual IRF only (M12, +5.5 letters; M24, +3.6).
","[{'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute, Chesterfield, Missouri, USA. Electronic address: nholekamp@gmail.com.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, University of California, Los Angeles, Pasadena, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sarraf', 'Affiliation': 'Stein Eye Institute, University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Guymer', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, and Department of Surgery (Ophthalmology), University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Blotner', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Galin', 'Initials': 'G', 'LastName': 'Spicer', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2021.06.029']
854,34291275,Metabolomics of the tryptophan-kynurenine degradation pathway and risk of atrial fibrillation and heart failure: potential modification effect of Mediterranean diet.,"BACKGROUND


The tryptophan-kynurenine pathway is linked to inflammation. We hypothesize that metabolites implicated in this pathway may be associated with the risk of heart failure (HF) or atrial fibrillation (AF) in a population at high risk of cardiovascular disease.
OBJECTIVES


We aimed to prospectively analyze the associations of kynurenine-related metabolites with the risk of HF and AF and to analyze a potential effect modification by the randomized interventions of the PREDIMED (Prevención con Dieta Mediterránea) trial with Mediterranean diet (MedDiet).
METHODS


Two case-control studies nested within the PREDIMED trial were designed. We selected 324 incident HF cases and 502 incident AF cases individually matched with ≤3 controls. Conditional logistic regression models were fitted. Interactions with the intervention were tested for each of the baseline plasma metabolites measured by LC-tandem MS.
RESULTS


Higher baseline kynurenine:tryptophan ratio (OR for 1 SD: 1.20; 95% CI: 1.01, 1.43) and higher levels of kynurenic acid (OR: 1.19; 95% CI: 1.01, 1.40) were associated with HF. Quinolinic acid was associated with AF (OR: 1.15; 95% CI: 1.01, 1.32) and HF (OR: 1.25; 95% CI: 1.04, 1.49). The MedDiet intervention modified the positive associations of kynurenine (Pinteraction = 0.006), kynurenic acid (Pinteraction = 0.008), and quinolinic acid (Pinteraction = 0.033) with HF and the association between kynurenic acid and AF (Pinteraction = 0.02).
CONCLUSIONS


We found that tryptophan-kynurenine pathway metabolites were prospectively associated with higher HF risk and to a lesser extent with AF risk. Moreover, an effect modification by MedDiet was observed for the association between plasma baseline kynurenine-related metabolites and the risk of HF, showing that the positive association of increased levels of these metabolites and HF was restricted to the control group.",2021,"The MedDiet intervention modified the positive associations of kynurenine (Pinteraction = 0.006), kynurenic acid (Pinteraction = 0.008), and quinolinic acid (Pinteraction = 0.033) with HF and the association between kynurenic acid and AF (Pinteraction = 0.02).
",['324 incident HF cases and 502 incident AF cases individually matched with ≤3 controls'],"['Mediterranean diet (MedDiet', 'Mediterranean diet']","['higher levels of kynurenic acid', 'Quinolinic acid']","[{'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022816', 'cui_str': 'Kynurenic acid'}, {'cui': 'C0034425', 'cui_str': 'Quinolinic Acids'}]",,0.299315,"The MedDiet intervention modified the positive associations of kynurenine (Pinteraction = 0.006), kynurenic acid (Pinteraction = 0.008), and quinolinic acid (Pinteraction = 0.033) with HF and the association between kynurenic acid and AF (Pinteraction = 0.02).
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Razquin', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ruiz-Canela', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Estefania', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Hernández-Alonso', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Clary B', 'Initials': 'CB', 'LastName': 'Clish', 'Affiliation': 'Broad Institute, Massachusetts Institute of Technology and Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Guasch-Ferré', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Wittenbecher', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Dennis', 'Affiliation': 'Broad Institute, Massachusetts Institute of Technology and Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Alonso-Gómez', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gómez-Gracia', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Fiol', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Aros', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Martínez-González', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab238']
855,34237262,"The effect of BCG revaccination on all-cause mortality beyond infancy: 30-year follow-up of a population-based, double-blind, randomised placebo-controlled trial in Malawi.","BACKGROUND


Trials of BCG vaccination to prevent or reduce severity of COVID-19 are taking place in adults, some of whom have been previously vaccinated, but evidence of the beneficial, non-specific effects of BCG come largely from data on mortality in infants and young children, and from in-vitro and animal studies, after a first BCG vaccination. We assess all-cause mortality following a large BCG revaccination trial in Malawi.
METHODS


The Karonga Prevention trial was a population-based, double-blind, randomised controlled in Karonga District, northern Malawi, that enrolled participants between January, 1986, and November, 1989. The trial compared BCG (Glaxo-strain) revaccination versus placebo to prevent tuberculosis and leprosy. 46 889 individuals aged 3 months to 75 years were randomly assigned to receive BCG revaccination (n=23 528) or placebo (n=23 361). Here we report mortality since vaccination as recorded during active follow-up in northern areas of the district in 1991-94, and in a demographic surveillance follow-up in the southern area in 2002-18. 7389 individuals who received BCG (n=3746) or placebo (n=3643) lived in the northern follow-up areas, and 5616 individuals who received BCG (n=2798) or placebo (n=2818) lived in the southern area. Year of death or leaving the area were recorded for those not found. We used survival analysis to estimate all-cause mortality.
FINDINGS


Follow-up information was available for 3709 (99·0%) BCG recipients and 3612 (99·1%) placebo recipients in the northern areas, and 2449 (87·5%) BCG recipients and 2413 (85·6%) placebo recipients in the southern area. There was no difference in mortality between the BCG and placebo groups in either area, overall or by age group or sex. In the northern area, there were 129 deaths per 19 694 person-years at risk in the BCG group (6·6 deaths per 1000 person-years at risk [95% CI 5·5-7·8]) versus 133 deaths per 19 111 person-years at risk in the placebo group (7·0 deaths per 1000 person-years at risk [95% CI 5·9-8·2]; HR 0·94 [95% CI 0·74-1·20]; p=0·62). In the southern area, there were 241 deaths per 38 399 person-years at risk in the BCG group (6·3 deaths per 1000 person-years at risk [95% CI 5·5-7·1]) versus 230 deaths per 38 676 person-years at risk in the placebo group (5·9 deaths per 1000 person-years at risk [95% CI 5·2-6·8]; HR 1·06 [95% CI 0·88-1·27]; p=0·54).
INTERPRETATION


We found little evidence of any beneficial effect of BCG revaccination on all-cause mortality. The high proportion of deaths attributable to non-infectious causes beyond infancy, and the long time interval since BCG for most deaths, might obscure any benefits.
FUNDING


British Leprosy Relief Association (LEPRA); Wellcome Trust.",2021,"There was no difference in mortality between the BCG and placebo groups in either area, overall or by age group or sex.","['n=2818) lived in the southern area', 'n=3643) lived in the northern follow-up areas, and 5616 individuals who received BCG (n=2798) or', '46', 'recipients in the southern area', '889 individuals aged 3 months to 75 years', 'northern areas of the district in 1991-94, and in a demographic surveillance follow-up in the southern area in 2002-18. 7389 individuals who received BCG (n=3746) or', 'Karonga District, northern Malawi, that enrolled participants between January, 1986, and November, 1989']","['BCG revaccination', 'placebo', 'BCG (Glaxo-strain) revaccination versus placebo']","['mortality', 'Year of death or leaving the area']","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C2713304', 'cui_str': 'Revaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",46889.0,0.542162,"There was no difference in mortality between the BCG and placebo groups in either area, overall or by age group or sex.","[{'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Glynn', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: judith.glynn@lshtm.ac.uk.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dube', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Chilumba and Lilongwe, Malawi.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fielding', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Amelia C', 'Initials': 'AC', 'LastName': 'Crampin', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK; Malawi Epidemiology and Intervention Research Unit, Chilumba and Lilongwe, Malawi.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Chifundo', 'Initials': 'C', 'LastName': 'Kanjala', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK; Malawi Epidemiology and Intervention Research Unit, Chilumba and Lilongwe, Malawi.'}, {'ForeName': 'Paul E M', 'Initials': 'PEM', 'LastName': 'Fine', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30994-4']
856,34242256,"The effect of mobile text messages on knowledge and perception towards cancer and behavioral risks among college students, Northeast Ethiopia: A randomized controlled trial protocol.","BACKGROUND


Cancer is an emerging public health problem in Ethiopia. A significant proportion of premature cancer deaths are preventable. The socioeconomic impact of cancer can be considerably reduced provided that effective interventions are put in place to control risk factors. Text-messaging has been currently targeted as a simple and efficient tool for providing people with health information.
OBJECTIVE


To evaluate the effectiveness of mobile text messages in improving knowledge and perception on cancer and behavioral risks among college students.
METHODS


Design: a single-blind, 2-arm randomized controlled trial will be used. Setting: the study will be conducted among public colleges in Dessie town, Northeast Ethiopia. Study population: students who are studying in all public colleges. Intervention: a text message related to cancer risk factors once a day for two months. Control groups will receive general health messages daily for two months. Data: Socioeconomic characteristics, health belief variables, and behavioral risk factors of cancer will be collected before and after the intervention. Text messages will be provided based on the health belief model (HBM). Primary outcomes: cancer risk knowledge score and risk perception will be measured at baseline and 6 months post-randomization. Secondary outcomes: a change in mean healthy diet score, physical activity level, alcohol intake, and tobacco use will be measured at baseline-, 3, and 6 months post-randomization. Analysis: We will compute descriptive statistics for each outcome pre and post-intervention. To test the change in knowledge and perception, paired t-test will be used. Analysis of Covariance will be used to test over group comparison.
TRIAL REGISTRATION


ClinicalTrials.gov (https://register.clinicaltrials.gov) NCT04269018.",2021,"Secondary outcomes: a change in mean healthy diet score, physical activity level, alcohol intake, and tobacco use will be measured at baseline-, 3, and 6 months post-randomization.","['public colleges in Dessie town, Northeast Ethiopia', 'college students', 'college students, Northeast Ethiopia', 'Study population: students who are studying in all public colleges']",['mobile text messages'],"['cancer risk knowledge score and risk perception', 'knowledge and perception on cancer and behavioral risks', 'knowledge and perception towards cancer and behavioral risks', 'change in mean healthy diet score, physical activity level, alcohol intake, and tobacco use will be measured at baseline', 'premature cancer deaths', 'Socioeconomic characteristics, health belief variables, and behavioral risk factors of cancer']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",,0.154591,"Secondary outcomes: a change in mean healthy diet score, physical activity level, alcohol intake, and tobacco use will be measured at baseline-, 3, and 6 months post-randomization.","[{'ForeName': 'Foziya Mohammed', 'Initials': 'FM', 'LastName': 'Hussien', 'Affiliation': 'Department of Public Health Nutrition, School of Public Health, College of Medicine and Health Science, Wollo University, Dessie, Ethiopia.'}, {'ForeName': 'Anissa Mohammed', 'Initials': 'AM', 'LastName': 'Hassen', 'Affiliation': 'Department of Epidemiology and Biostatics, School of Public Health, College of Medicine and Health Science, Wollo University, Dessie, Ethiopia.'}, {'ForeName': 'Zinet Abegaz', 'Initials': 'ZA', 'LastName': 'Asfaw', 'Affiliation': 'Department of Reproductive and Family Health, School of Public Health, College of Medicine and Health Science, Wollo University, Dessie, Ethiopia.'}, {'ForeName': 'Aragaw Yimer', 'Initials': 'AY', 'LastName': 'Ahmed', 'Affiliation': 'Department of Internal Medicine, School of Medicine, College of Medicine and Health science, Wollo University, Dessie, Ethiopia.'}, {'ForeName': 'Hamid Yimam', 'Initials': 'HY', 'LastName': 'Hassen', 'Affiliation': 'Department of Primary and Interdisciplinary Care, University of Antwerp, Antwerp, Belgium.'}]",PloS one,['10.1371/journal.pone.0253839']
857,34256159,Associations between caregiver mastery and anxiety in persons living with dementia: A study of dyads living in community.,"Anxiety is common in persons living with dementia (PLWD), and particularly burdensome for caregivers. Little is known about how caregiver factors such as caregiver mastery can influence anxiety in PLWD. This study was conducted to examine the relationship between caregiver mastery and anxiety in PLWD. Secondary data analysis was conducted using baseline data from a randomized controlled trial of 170 dyads of community residing PLWD and their caregivers. Logistic regression analyses were used for data analyses. After controlling for covariates (e.g., age, cognitive impairment, sleep impairment, and depression), a higher level of caregiver mastery was related to lower odds of anxiety presentation in PLWD (OR=0.870, 95% CI=0.759-0.998, p=0.046). As caregiver mastery is related to anxiety in PLWD, a comprehensive education program for caregivers that can improve their caregiving skills and mastery is suggested to improve anxiety in PLWD.",2021,"After controlling for covariates (e.g., age, cognitive impairment, sleep impairment, and depression), a higher level of caregiver mastery was related to lower odds of anxiety presentation in PLWD (OR=0.870, 95% CI=0.759-0.998, p=0.046).","['persons living with dementia', 'dyads living in community', '170 dyads of community residing PLWD and their caregivers', 'persons living with dementia (PLWD']",[],"['cognitive impairment, sleep impairment, and depression']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",[],"[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",170.0,0.170058,"After controlling for covariates (e.g., age, cognitive impairment, sleep impairment, and depression), a higher level of caregiver mastery was related to lower odds of anxiety presentation in PLWD (OR=0.870, 95% CI=0.759-0.998, p=0.046).","[{'ForeName': 'Yeji', 'Initials': 'Y', 'LastName': 'Hwang', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia, PA, United States. Electronic address: yejih@nursing.upenn.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hodgson', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia, PA, United States.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.06.019']
858,34255767,Cognitive impairment in syphilis: Does treatment based on cerebrospinal fluid analysis improve outcome?,"BACKGROUND


Individuals with previous syphilis may experience cognitive impairment. The goal of this study was to determine if those at high risk for laboratory-defined neurosyphilis are cognitively impaired, and whether treatment based on cerebrospinal fluid (CSF) findings results in better outcomes.
METHODS


Participants had a new syphilis diagnosis, serum RPR titer ≥ 1:32 or peripheral blood CD4+ T cells ≤ 350/ul (in persons living with HIV) and did not endorse neurological symptoms. They underwent computerized cognitive assessment with the CogState. Thirty-two were randomized to either undergo lumbar puncture (LP) or to not undergo LP and 14 underwent LP; 64 were not randomized and 48 opted to undergo LP.
RESULTS


Demographics, cognitive complaints and cognitive impairment did not differ between randomized and nonrandomized participants. Two-thirds were cognitively impaired, and impairment was not more common in those with cognitive complaints. The adjusted odds of increased severity of impairment were 3.8 times greater in those with CSF pleocytosis compared to those without. Time to cognitive normalization, improvement or decline did not differ between those who did not undergo LP and those who underwent LP and whose treatment was based on CSF analysis. Taking into account pre-treatment cognitive impairment, the risk of cognitive decline was lower in those with CSF pleocytosis treated for neurosyphilis compared to those without CSF pleocytosis not treated for neurosyphilis, (HR 0.24 (95% CI 0.07-0.88], p = 0.03).
CONCLUSION


In individuals at high risk for laboratory-defined neurosyphilis, cognitive complaints are not a good indicator of cognitive impairment. Severity of cognitive impairment was greater in those with CSF pleocytosis. Identification and treatment of those with neurosyphilis may mitigate subsequent cognitive decline.",2021,"Time to cognitive normalization, improvement or decline did not differ between those who did not undergo LP and those who underwent LP and whose treatment was based on CSF analysis.","['Individuals with previous syphilis may experience cognitive impairment', 'Cognitive impairment in syphilis', 'Participants had a new syphilis diagnosis, serum RPR titer ≥', 'Thirty-two were randomized to either']",['undergo lumbar puncture (LP) or to not undergo LP and 14 underwent LP'],"['Time to cognitive normalization, improvement or decline', 'cognitive complaints and cognitive impairment', 'severity of impairment', 'risk of cognitive decline', 'Severity of cognitive impairment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201405', 'cui_str': 'Rapid plasma reagin test'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]",32.0,0.0584277,"Time to cognitive normalization, improvement or decline did not differ between those who did not undergo LP and those who underwent LP and whose treatment was based on CSF analysis.","[{'ForeName': 'Arielle P', 'Initials': 'AP', 'LastName': 'Davis', 'Affiliation': 'Department of Neurology, Division of Infectious Diseases, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Maxwell', 'Affiliation': 'Department of Neurology, Division of Infectious Diseases, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Mendoza', 'Affiliation': 'Department of Neurology, Division of Infectious Diseases, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Crooks', 'Affiliation': 'Department of Neurology, Division of Infectious Diseases, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Shelia B', 'Initials': 'SB', 'LastName': 'Dunaway', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Sher', 'Initials': 'S', 'LastName': 'Storey', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Stevens', 'Affiliation': 'Department of Neurology, Division of Infectious Diseases, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Tantalo', 'Affiliation': 'Department of Neurology, Division of Infectious Diseases, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Sahi', 'Affiliation': 'Department of Neurology, Division of Infectious Diseases, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Robertson', 'Affiliation': 'Department of Neurology, University of North Carolina, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Marra', 'Affiliation': 'Department of Neurology, Division of Infectious Diseases, University of Washington, Seattle, Washington, United States of America.'}]",PloS one,['10.1371/journal.pone.0254518']
859,34264439,Final results of the double-blind placebo-controlled randomized phase 2 LOTUS trial of first-line ipatasertib plus paclitaxel for inoperable locally advanced/metastatic triple-negative breast cancer.,"PURPOSE


In LOTUS (NCT02162719), adding the oral AKT inhibitor ipatasertib to first-line paclitaxel for locally advanced/metastatic triple-negative breast cancer (aTNBC) improved progression-free survival (PFS; primary endpoint), with an enhanced effect in patients with PIK3CA/AKT1/PTEN-altered tumors (FoundationOne next-generation sequencing [NGS] assay). We report final overall survival (OS) results.
METHODS


Eligible patients had measurable previously untreated aTNBC. Patients were stratified by prior (neo)adjuvant therapy, chemotherapy-free interval, and tumor immunohistochemistry PTEN status, and were randomized 1:1 to paclitaxel 80 mg/m 2  (days 1, 8, 15) plus ipatasertib 400 mg or placebo (days 1-21) every 28 days until disease progression or unacceptable toxicity. OS (intent-to-treat [ITT], immunohistochemistry PTEN-low, and PI3K/AKT pathway-activated [NGS PIK3CA/AKT1/PTEN-altered] populations) was a secondary endpoint.
RESULTS


Median follow-up was 19.0 versus 16.0 months in the ipatasertib-paclitaxel versus placebo-paclitaxel arms, respectively. In the ITT population (n = 124), median OS was numerically longer with ipatasertib-paclitaxel than placebo-paclitaxel (hazard ratio 0.80, 95% CI 0.50-1.28; median 25.8 vs 16.9 months, respectively; 1-year OS 83% vs 68%). Likewise, median OS favored ipatasertib-paclitaxel in the PTEN-low (n = 48; 23.1 vs 15.8 months; hazard ratio 0.83) and PIK3CA/AKT1/PTEN-altered (n = 42; 25.8 vs 22.1 months; hazard ratio 1.13) subgroups. The ipatasertib-paclitaxel safety profile was unchanged.
CONCLUSIONS


Final OS results show a numerical trend favoring ipatasertib-paclitaxel and median OS exceeding 2 years with ipatasertib-paclitaxel. Overall, results are consistent with the reported PFS benefit; interpretation within biomarker-defined subgroups is complicated by small sample sizes and TNBC heterogeneity.",2021,"In the ITT population (n = 124), median OS was numerically longer with ipatasertib-paclitaxel than placebo-paclitaxel (hazard ratio 0.80, 95% CI 0.50-1.28; median 25.8 vs 16.9 months, respectively; 1-year OS 83% vs 68%).","['Patients were stratified by prior (neo)adjuvant therapy, chemotherapy-free\xa0interval, and tumor immunohistochemistry PTEN status', 'inoperable locally advanced/metastatic triple-negative breast cancer', 'Eligible patients had measurable previously untreated aTNBC']","['placebo', 'paclitaxel 80\xa0mg/m 2  (days 1, 8, 15) plus ipatasertib 400\xa0mg or placebo', 'placebo-paclitaxel', 'paclitaxel']",['median OS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C1430988', 'cui_str': 'PTEN protein, human'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3712838', 'cui_str': '2-(4-chlorophenyl)-1-(4-(7-hydroxy-5-methyl-6,7-dihydro-5H-cyclopenta(d)pyrimidin-4-yl)piperazin-1-yl)-3-(isopropylamino)propan-1-one'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.561052,"In the ITT population (n = 124), median OS was numerically longer with ipatasertib-paclitaxel than placebo-paclitaxel (hazard ratio 0.80, 95% CI 0.50-1.28; median 25.8 vs 16.9 months, respectively; 1-year OS 83% vs 68%).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dent', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore. rebecca.dent@duke-nus.edu.sg.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Isakoff', 'Affiliation': 'Division of Hematology and Oncology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Espié', 'Affiliation': 'Department of Medical Oncology, Breast Disease Center, Hospital Saint Louis, Paris, France.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Blau', 'Affiliation': 'Oncology Division, Northwest Medical Specialties, Puyallup, WA, USA.'}, {'ForeName': 'Antoinette R', 'Initials': 'AR', 'LastName': 'Tan', 'Affiliation': 'Department of Solid Tumor and Investigational Therapeutics, Levine Cancer Institute, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Wongchenko', 'Affiliation': 'Oncology Biomarker Development, Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Biostatistics, Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bradley', 'Affiliation': 'Pharma Development, Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Sarah-Jayne', 'Initials': 'SJ', 'LastName': 'Reilly', 'Affiliation': 'Pharma Development, Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Mani', 'Affiliation': 'Product Development Oncology, Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Breast cancer research and treatment,['10.1007/s10549-021-06143-5']
860,34262006,Feasibility and Acceptability of a Reiki Intervention With Very Young Children Receiving Palliative Care.,"BACKGROUND


Very little research has been reported examining nonpharmacological symptom management strategies for very young, hospitalized children receiving palliative care, and none has involved Reiki-a light touch therapy.
OBJECTIVES


The aim of this study was to determine if completing a Reiki intervention with hospitalized 1- to 5-year-old children with chronic, life-limiting conditions receiving palliative care was feasible and acceptable.
METHODS


Children ages 1-5 years receiving palliative care who were expected to be hospitalized for at least 3 weeks were recruited for a single-arm, mixed-methods, quasi-experimental pre- and poststudy. Six protocolized Reiki sessions were conducted over 3 weeks. We calculated feasibility by the percentage of families enrolled in the study and acceptability by the percentage of families who completed all measures and five out of six Reiki sessions. Measures were collected at baseline, at the end of the intervention period, and 3 weeks later. At the final follow-up visit, parents were verbally asked questions relating to the acceptability of the intervention in a short structured interview.
RESULTS


We screened 90 families, approached 31 families, and recruited 16 families, whereas 15 families declined. Reasons for not participating included that the child had ""a lot going on,"" would be discharged soon, and families were overwhelmed. Of those enrolled, most completed all measures at three time points and five out of six Reiki sessions. We completed nearly all scheduled Reiki sessions for families that finished the study. All parents reported that they would continue the Reiki if they could, and almost all said they would participate in the study again; only one parent was unsure.
DISCUSSION


Young children and their parents found Reiki acceptable; these results are comparable to an earlier study of children 7-16 years of age receiving palliative care at home and a study of massage for symptom management for hospitalized children with cancer. These findings add to the literature and support further investigation of Reiki's efficacy as a nonpharmacological symptom management intervention.",2021,"At the final follow-up visit, parents were verbally asked questions relating to the acceptability of the intervention in a short structured interview.
","['with hospitalized 1- to 5-year-old children with chronic, life-limiting conditions receiving palliative care', 'Very Young Children Receiving Palliative Care', 'hospitalized children with cancer', 'Young children', 'Children ages 1 to 5 years receiving palliative care who were expected to be hospitalized for at least 3 weeks were recruited for a single-arm, mixed-methods, quasi-experimental pre/poststudy', 'very young, hospitalized children receiving palliative care', 'We screened 90 families, approached 31 families, and recruited 16 families while 15 families declined']","['Reiki Intervention', 'Reiki intervention']",['Feasibility and Acceptability'],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0751715', 'cui_str': 'Reiki'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",90.0,0.0294725,"At the final follow-up visit, parents were verbally asked questions relating to the acceptability of the intervention in a short structured interview.
","[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Thrane', 'Affiliation': ''}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': ''}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Shaner', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friebert', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000540']
861,34266940,Effect of exacerbation history on clinical response to dupilumab in moderate-to-severe uncontrolled asthma.,"BACKGROUND


The phase 3 LIBERTY ASTHMA QUEST study (ClinicalTrials.gov: NCT02414854) in patients with uncontrolled, moderate-to-severe asthma has demonstrated the efficacy and safety of dupilumab 200 and 300 mg every 2 weeks  versus  placebo. This  post hoc  analysis assessed the effect of dupilumab on efficacy outcomes and asthma control across a range of historical exacerbation rates in patients with type 2-high asthma.
METHODS


Annualised severe exacerbation rates over the 52-week treatment period, pre-bronchodilator forced expiratory volume in 1 s (FEV 1 ) at weeks 12 and 52, and the five-item Asthma Control Questionnaire (ACQ-5) score at weeks 24 and 52 were assessed in patients with ≥1, ≥2 or ≥3 exacerbations in the previous year. Subgroups were stratified by baseline blood eosinophils ≥150 or ≥300 cells·μL -1  or baseline exhaled nitric oxide fraction ≥25 ppb and baseline inhaled corticosteroid (ICS) dose.
RESULTS


Across all type 2-high subgroups, dupilumab  versus  placebo significantly reduced severe exacerbations by 54-90%, with greater improvements in patients with more exacerbations prior to study initiation. Similarly, improvements in FEV 1  (least squares (LS) mean difference  versus  placebo: ≥1 exacerbations, 0.15-0.25 L; ≥2 exacerbations, 0.12-0.32 L; ≥3 exacerbations, 0.09-0.38 L; majority p<0.05) and ACQ-5 score (LS mean difference range: ≥1 exacerbations, -0.30 to -0.57; ≥2 exacerbations, -0.29 to -0.56; ≥3 exacerbations, -0.43 to -0.61; all p<0.05) were observed, irrespective of prior exacerbation history, across all subgroups.
CONCLUSIONS


Dupilumab significantly reduced severe exacerbations and improved FEV 1  and asthma control in patients with elevated type 2 biomarkers irrespective of exacerbation history and baseline ICS dose.",2021,"Across all type 2-high subgroups, dupilumab  versus  placebo significantly reduced severe exacerbations by 54 to 90%, with greater improvements in patients with more exacerbations prior to study initiation.","['moderate-severe uncontrolled asthma', 'patients with uncontrolled, moderate-to-severe asthma', 'patients with type 2-high asthma', 'Subgroups were stratified by baseline blood eosinophils ≥150 or ≥300\u2005cells·μL -1  or baseline fractional exhaled nitric oxide ≥25\u2005ppb and baseline inhaled corticosteroid dose']","['dupilumab', 'placebo']","['severe exacerbations', '5-item Asthma Control Questionnaire (ACQ-5) score', 'historical exacerbation rates', 'ACQ-5 score', 'severe exacerbation rates']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0032441', 'cui_str': 'Polybrominated biphenyl'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.245864,"Across all type 2-high subgroups, dupilumab  versus  placebo significantly reduced severe exacerbations by 54 to 90%, with greater improvements in patients with more exacerbations prior to study initiation.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA jcorren@ucla.edu.'}, {'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Katelaris', 'Affiliation': 'Campbelltown Hospital, Campbelltown, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Jorge F', 'Initials': 'JF', 'LastName': 'Maspero', 'Affiliation': 'Fundación CIDEA, Buenos Aires, Argentina.'}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Ford', 'Affiliation': 'The Asthma and Allergy Center, Bellevue, NE, USA.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Radwan', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Yamo', 'Initials': 'Y', 'LastName': 'Deniz', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Djandji', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}]",The European respiratory journal,['10.1183/13993003.04498-2020']
862,34270689,Root resorption associated with maxillary buccal segment intrusion using variable force magnitudes.,"OBJECTIVES


To compare the root resorption resulting from miniscrew-supported maxillary posterior dentoalveolar intrusion using two different force magnitudes.
MATERIALS AND METHODS


Adult patients with skeletal open bite, indicated for maxillary posterior dentoalveolar intrusion, were recruited and randomly assigned to the comparison or intervention groups. The comparison group involved applying 200 g of intrusive force per segment, which measured 20 g per root, while this force was 400 g per segment in the intervention group, measuring 40 g per root.
RESULTS


Twenty participants were included in the final analysis after 2 patients dropped out, 1 in each group, to end up with 10 subjects (200 roots) per group. There was statistically significant root resorption of 0.84 ± 0.96 mm and 0.93 ± 1.00 mm in the comparison and the intervention groups, respectively. However, there was no statistically significant difference between the groups.
CONCLUSIONS


Root resorption inevitably took place in association with orthodontic intrusion. However, increasing the magnitude of the intrusive force did not increase the amount of root resorption, either statistically or clinically.",2021,"However, increasing the magnitude of the intrusive force did not increase the amount of root resorption, either statistically or clinically.","['Twenty participants were included in the final analysis after 2 patients dropped out, 1 in each group, to end up with 10 subjects (200 roots) per group', 'Adult patients with skeletal open bite, indicated for maxillary posterior dentoalveolar intrusion']",[],"['Root resorption', 'amount of root resorption', 'root resorption']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0266061', 'cui_str': 'Open bite'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",[],"[{'cui': 'C0035851', 'cui_str': 'Root Resorption'}]",20.0,0.0352946,"However, increasing the magnitude of the intrusive force did not increase the amount of root resorption, either statistically or clinically.","[{'ForeName': 'Heba E', 'Initials': 'HE', 'LastName': 'Akl', 'Affiliation': ''}, {'ForeName': 'Amr R', 'Initials': 'AR', 'LastName': 'El-Beialy', 'Affiliation': ''}, {'ForeName': 'Mohamed Abd', 'Initials': 'MA', 'LastName': 'El-Ghafour', 'Affiliation': ''}, {'ForeName': 'Amr M', 'Initials': 'AM', 'LastName': 'Abouelezz', 'Affiliation': ''}, {'ForeName': 'Fouad A', 'Initials': 'FA', 'LastName': 'El Sharaby', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/012121-62.1']
863,34270620,Acute effects of a single dose of 2 mA of anodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex on executive functions in patients with schizophrenia-A randomized controlled trial.,"OBJECTIVE


Cognitive impairments are a frequent and difficult to treat symptom in patients with schizophrenia and the strongest predictor for a successful reintegration in occupational and everyday life. Recent research suggests transcranial direct current stimulation (tDCS) to enhance cognition in this patient group. However, the question regarding its acute effectiveness on executive functions remains largely unanswered. Here, we examined in a randomized, double blind, sham-controlled repeated-measures design the impact of tDCS on performance in several executive functions in patients with schizophrenia, schizoaffective disorder or acute transient psychotic disorder.
METHODS


Patients (N = 48) were tested twice using standardized, well-constructed and clinically validated neuropsychological tests assessing verbal working memory, response inhibition, mental flexibility and problem solving. In session 1 they solely underwent the neuropsychological assessment, whereas in session 2 they additionally received 2 mA of anodal tDCS stimulation over the left dorsolateral prefrontal cortex (DLPFC), cathode right supraorbital ridge, or sham stimulation for 20 minutes.
RESULTS


Patients of both groups were not able to correctly discriminate the type of stimulation received confirming the success of the blinding procedure. However, analyzing the whole sample the change in performance from session 1 to session 2 was the same in the verum as in the sham condition (all p >.5). Moreover, a subsequent exploratory analysis showed that performance in the response inhibition task was worse for patients that engaged in the task within 20 minutes after the end of the verum stimulation.
CONCLUSION


Hence, 2 mA of anodal tDCS applied over the left DLPFC did not acutely enhance executive functions in patients with schizophrenia or related disorders but impaired performance in the response inhibition task shortly after. Future studies should continue to seek for effective stimulation configurations for this patient group.
CLINICAL TRIAL REGISTRATION


The study is registered in the ""Deutsches Register Klinischer Studien DRKS"", German Clinical Trial Register and has been allocated the following number: DRKS00022126.",2021,"Moreover, a subsequent exploratory analysis showed that performance in the response inhibition task was worse for patients that engaged in the task within 20 minutes after the end of the verum stimulation.
","['patients with schizophrenia', 'patients with schizophrenia, schizoaffective disorder or acute transient psychotic disorder', 'patients with schizophrenia or related disorders', 'Patients (N = 48']","['anodal transcranial direct current stimulation', 'tDCS', '2 mA of anodal tDCS stimulation over the left dorsolateral prefrontal cortex (DLPFC), cathode right supraorbital ridge, or sham stimulation for 20 minutes', 'transcranial direct current stimulation (tDCS']","['response inhibition task', 'verbal working memory, response inhibition, mental flexibility and problem solving', 'executive functions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0349198', 'cui_str': 'Acute transient psychotic disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",48.0,0.13091,"Moreover, a subsequent exploratory analysis showed that performance in the response inhibition task was worse for patients that engaged in the task within 20 minutes after the end of the verum stimulation.
","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Schilling', 'Affiliation': 'Section of Clinical Psychology and Neuropsychology, SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Bossert', 'Affiliation': 'Section of Clinical Psychology and Neuropsychology, SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'König', 'Affiliation': 'Section of Clinical Psychology and Neuropsychology, SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Wirtz', 'Affiliation': 'SRH Psychiatric Rehabilitation Center, Karlsbad, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weisbrod', 'Affiliation': 'Department of Psychiatry and Psychotherapy, SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Aschenbrenner', 'Affiliation': 'Section of Clinical Psychology and Neuropsychology, SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany.'}]",PloS one,['10.1371/journal.pone.0254695']
864,34270615,The patient satisfaction in primary care consultation-Questionnaire (PiC): An instrument to assess the impact of patient-centred communication on patient satisfaction.,"BACKGROUND


Primary care consultation is significantly influenced by communication between the General Practitioner (GP) and their patients. Hypothesising that patient satisfaction can be tested based on an expectation-experience comparison, the aim of this article is to discuss the influence of communication on patient satisfaction.
METHODS


A standardised questionnaire was developed striving for a universal primary care survey tool that focuses on patient satisfaction in the context of patient-centred-communication. The sample consisted of 14 German GPs with 80 patients each (n = 1120). Due to the inclusion in an overarching cluster-randomised-study (CRT), the medical practices to be examined were divided into intervention and control groups. The intervention was developed as a reflective training on patient-centred communication.
RESULTS


The results in the present sample show no correlation between patient-centred-communication and patient satisfaction. There are also no significant differences between the intervention and control group.
DISCUSSION


The results raise the question to what extent patient satisfaction can be shaped significantly through patient-centred-communication. The presented project represents part of the basic research in general medical care research and contributes to the transparent processing of theoretical assumptions. With the results described here, communication models with a focus on patient centredness can be evaluated with regard to their practical relevance and transferability.",2021,"There are also no significant differences between the intervention and control group.
",['primary care consultation-Questionnaire (PiC'],[],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0730321', 'cui_str': 'Punctate inner choroidopathy'}]",[],[],14.0,0.0327685,"There are also no significant differences between the intervention and control group.
","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Stark', 'Affiliation': 'Institute of General Practice, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Worm', 'Affiliation': 'Institute of General Practice, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kluge', 'Affiliation': 'Institute of General Practice, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Roos', 'Affiliation': 'Institute of General Practice, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Burggraf', 'Affiliation': 'Institute of General Practice, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}]",PloS one,['10.1371/journal.pone.0254644']
865,34277985,Effect of metformin on the high-density lipoprotein proteome in youth with type 1 diabetes.,"Background


Youth with type 1 diabetes (T1D) have normal or elevated High-Density Lipoprotein Cholesterol (HDL-C), however, the function of HDL, partly mediated by the HDL proteome, may be impaired. Metformin can be used as an adjunct therapy in youth with T1D, but its effects on the HDL proteome are unknown.
Objective


To determine the effect of metformin on the HDL proteome.
Subjects


Youth (12-20 years old) with T1D who had a BMI > 90th percentile, HbA1c > 8.0% and Tanner stage 5.
Methods


Double-blinded, placebo-controlled randomized sub-study. We examined the effects of metformin ( n  = 25) or placebo ( n  = 10) after 6 months on HDL proteome. Changes in HDL proteins were measured by data-independent acquisition (DIA) mass spectrometry and compared between treatment groups. As a secondary outcome, associations between proteins of interest and the most studied function of HDL, the cholesterol efflux capacity (CEC), was examined.
Results


The relative abundance of 84 HDL-associated proteins were measured. Two proteins were significantly affected by metformin treatment, peptidoglycan recognition protein 2 (PGRP2; +23.4%,  p  = .0058) and alpha-2-macroglobulin (A2MG; +29.8%,  p  = .049). Metformin did not significantly affect CEC. Changes in affected HDL proteins did not correlate with CEC.
Conclusions


Despite having little effect on HDL-C, metformin increased PGRP2 and A2MG protein on HDL in youth with T1D, but had no significant effect on CEC. Further studies are needed to understand the impact of PGRP2 and A2MG on other HDL functions.",2021,"Two proteins were significantly affected by metformin treatment, peptidoglycan recognition protein 2 (PGRP2; +23.4%,  p  = .0058) and alpha-2-macroglobulin (A2MG; +29.8%,  p  = .049).","['\n\n\nYouth with type 1 diabetes (T1D', 'youth with T1D', 'Subjects\n\n\nYouth (12-20\xa0years old) with T1D who had a BMI', 'youth with type 1 diabetes']","['placebo', 'metformin', 'Metformin']","['CEC', 'HDL proteins', 'function of HDL, the cholesterol efflux capacity (CEC']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",2.0,0.0897291,"Two proteins were significantly affected by metformin treatment, peptidoglycan recognition protein 2 (PGRP2; +23.4%,  p  = .0058) and alpha-2-macroglobulin (A2MG; +29.8%,  p  = .049).","[{'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Gourgari', 'Affiliation': 'Division of Pediatric Endocrinology Department of Pediatrics Georgetown University Washington DC USA.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': 'Division of Pediatric Endocrinology Department of Pediatrics University of Colorado Anschutz Medical Campus Aurora CO USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pyle', 'Affiliation': 'Division of Pediatric Endocrinology Department of Pediatrics University of Colorado Anschutz Medical Campus Aurora CO USA.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Playford', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases National Heart, Lung, and Blood Institute National Institutes of Health Bethesda MD USA.'}, {'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Proteomics and Metabolomics Shared Resource Georgetown University Medical Center Washington DC USA.'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases National Heart, Lung, and Blood Institute National Institutes of Health Bethesda MD USA.'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Remaley', 'Affiliation': 'Lipoprotein Metabolism Section National Heart, Lung and Blood Institute National Institutes of Health Bethesda MD USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Gordon', 'Affiliation': 'Saha Cardiovascular Research Center University of Kentucky Lexington KY USA.'}]","Endocrinology, diabetes & metabolism",['10.1002/edm2.261']
866,34285165,"Immunogenicity and Safety of AS03-adjuvanted H5N1 Influenza Vaccine in Children 6-35 Months of Age: Results From a Phase 2, Randomized, Observer-blind, Multicenter, Dose-ranging Study.","BACKGROUND


This phase 2 observer-blind, randomized, multicenter, dose-ranging study evaluated immunogenicity and safety of different formulations of an AS03-adjuvanted H5N1 influenza vaccine in children 6-35 months of age.
METHODS


One hundred eighty-five children randomized into 5 groups [1.9 µg hemagglutinin (HA)/AS03B, 0.9 µg HA/AS03C, 1.9 µg HA/AS03C, 3.75 µg HA/AS03C or 3.75 µg HA/AS03D] were to receive 2 doses administered 21 days apart (primary vaccination). AS03 was classified by amount of DL-α-tocopherol, with AS03B the highest amount. One year later, all subjects were to receive unadjuvanted 3.75 µg HA as antigen challenge. Immunogenicity was assessed 21 days after primary vaccination (day 42) and 7 days after antigen challenge (day 392). Immunogenicity-fever index, based on hemagglutination inhibition and microneutralization antibody titers at day 42 and fever 7 days after each vaccination, was used to guide the selection of an acceptable formulation.
RESULTS


After primary vaccination, formulations elicited strong homologous immune responses with all subjects' hemagglutination inhibition titers ≥1:40 post-vaccination. Immunogenicity-fever index based on hemagglutination inhibition and microneutralization assays showed that 1.9 µg HA/AS03B ranked the highest. Antibody levels persisted >4 times above baseline 12 months after primary vaccination with all formulations (day 385). Antibodies increased >4-fold after antigen challenge (day 392/day 385) with 1.9 µg HA/AS03B, 0.9 µg HA/AS03C and 1.9 µg HA/AS03C formulations. Overall per subject, the incidence of fever ranged from 28.6% (3.75 µg HA/AS03D) to 60.5% (1.9 µg HA/AS03B).
CONCLUSIONS


All formulations were highly immunogenic and demonstrated acceptable safety profiles, with the 1.9 µg HA/AS03B providing the most favorable balance of immunogenicity versus reactogenicity for use in children 6-35 months of age.",2021,"After primary vaccination, formulations elicited strong homologous immune responses with all subjects' hemagglutination inhibition titers ≥1:40 post-vaccination.","['children 6-35 months of age', 'One hundred eighty-five children randomized into 5 groups [1.9 µg', 'Children 6-35 Months of Age']","['hemagglutinin (HA)/AS03B, 0.9 µg HA/AS03C, 1.9 µg HA/AS03C, 3.75 µg HA/AS03C or 3.75 µg HA/AS03D', 'AS03-adjuvanted H5N1 influenza vaccine', 'AS03-adjuvanted H5N1 Influenza Vaccine']","['Immunogenicity and Safety', 'hemagglutination inhibition and microneutralization antibody titers', 'incidence of fever', 'Immunogenicity-fever index', 'Antibodies', 'Immunogenicity', 'Antibody levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517517', 'cui_str': '1.9'}]","[{'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C2934792', 'cui_str': 'ASO3B adjuvant'}, {'cui': 'C2748361', 'cui_str': 'H5N1 influenza'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",185.0,0.0648053,"After primary vaccination, formulations elicited strong homologous immune responses with all subjects' hemagglutination inhibition titers ≥1:40 post-vaccination.","[{'ForeName': 'Joon Hyung', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'From the Vaccines Clinical Research and Development, GSK, Rockville, Maryland.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Drame', 'Affiliation': 'Vaccine Biostatistics Department, GSK, Rockville, Maryland.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Department of Pediatrics, Center of Excellence in Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nan-Chang', 'Initials': 'NC', 'LastName': 'Chiu', 'Affiliation': ""Department of Pediatrics, Mackay Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'Department of Internal Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Hsun', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': 'Department of Pediatrics, Chang Gung Memorial Hospital, Chang Gung University Col-lege of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Po-Yen', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Kao-Pin', 'Initials': 'KP', 'LastName': 'Hwang', 'Affiliation': ""Division of Pediatric Infectious Diseases, China Medical University College of Medicine, Children's Hospital, Taichung, Taiwan.""}, {'ForeName': 'Jasur', 'Initials': 'J', 'LastName': 'Danier', 'Affiliation': 'Clinical and Epi Research and Development, GSK, Rockville, Maryland.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Friel', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Salaun', 'Affiliation': 'Clinical Laboratory Sciences, GSK, Rixensart, Belgium.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Woo', 'Affiliation': 'Biostatistics and Statistical Programming Department, GSK, Rockville, Maryland.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Vaughn', 'Affiliation': 'Vaccines Research and Development, GSK, Rockville, Maryland.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Innis', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Washington, District of Columbia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schuind', 'Affiliation': 'Vaccine Discovery and Development, GSK, Rockville, Maryland, USA.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000003247']
867,34297067,"Bone turnover in pregnancy, measured by urinary CTX, is influenced by vitamin D supplementation and is associated with maternal bone health: findings from the Maternal Vitamin D Osteoporosis Study (MAVIDOS) trial.","BACKGROUND


The pattern of change in maternal bone turnover throughout pregnancy is poorly characterized.
OBJECTIVES


We investigated changes across pregnancy in a marker of maternal bone resorption, urinary C-terminal telopeptide of type I collagen (CTX), the influence of gestational vitamin D supplementation, and associations between CTX and maternal postnatal bone indices.
METHODS


MAVIDOS (the Maternal Vitamin D Osteoporosis Study) is a randomized, double-blind, placebo-controlled trial of 1000 IU cholecalciferol/d compared with placebo from 14 weeks of gestation to birth. Maternal second-void urinary α- and β-CTX were measured (ELISA) at 14 and 34 weeks of gestation; DXA was performed within 2 wk postpartum. The Mann-Whitney Rank Sum test, Spearman's rank correlation, and linear regression were used to compare median CTX values within and between groups from early to late pregnancy, and associations with maternal bone outcomes.
RESULTS


In total, 372 women had CTX and 25-hydroxyvitamin D [25(OH)D] measured in early and late pregnancy. CTX at 14 and 34 weeks of gestation were correlated in both placebo (r = 0.31) and cholecalciferol (r = 0.45) groups (P < 0.0001). Median CTX increased from 14 to 34 weeks of gestation in both groups (n = 372 total) [placebo (n = 188): from 223.6 to 449.7 μg/mmol creatinine; cholecalciferol (n = 184): from 222.3 to 419.3 μg/mmol creatinine; P = 0.03 for placebo compared with cholecalciferol difference in CTX at 34 weeks of gestation]. The conditional mean ± SD increase in CTX [z-score (SD)] from early to late pregnancy was greater in the placebo group (n = 188) than in the cholecalciferol group (n = 184) (placebo: 0.16 ± 0.92; cholecalciferol: -0.16 ± 1.06; P-difference < 0.01). Higher CTX at 34 weeks of gestation was associated, similarly in both groups, with lower maternal total hip and lumbar spine bone mineral content and bone mineral density (BMD) (e.g., lumbar spine BMD: β = -0.02 g · cm-2 · SD-1 increase in CTX; 95% CI: -0.027, -0.002 g · cm-2 · SD-1; P = 0.02, n = 283).
CONCLUSIONS


Maternal urinary CTX, a bone resorption marker, rises through pregnancy, although to a lesser degree with gestational cholecalciferol supplementation, and is inversely associated with maternal bone mass postpartum.This trial was registered at www.isrctn.com as ISRCTN 82927713 and eudract.ema.europa.eu as EudraCT 2007-001716-23.",2021,"Higher CTX at 34 weeks' gestation was associated, similarly in both groups, with lower maternal total hip and lumbar spine bone mineral content (BMC) and bone mineral density, e.g., lumbar spine BMD [β= ",['372 women had'],"['vitamin D supplementation', 'CTX', '95%CI', 'cholecalciferol vs placebo', 'cholecalciferol', 'placebo']","['Median CTX(μg/mmol creatinine', 'maternal total hip and lumbar spine bone mineral content (BMC) and bone mineral density, e.g., lumbar spine BMD [β', 'CTX', 'CTX(SD', 'CTX and 25(OH)-vitamin D', 'Maternal second void urinary α']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}]",372.0,0.380087,"Higher CTX at 34 weeks' gestation was associated, similarly in both groups, with lower maternal total hip and lumbar spine bone mineral content (BMC) and bone mineral density, e.g., lumbar spine BMD [β= ","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Curtis', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Parsons', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Maslin', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': ""D'Angelo"", 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Moon', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Crozier', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Gossiel', 'Affiliation': 'Academic Unit of Bone Metabolism, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Bishop', 'Affiliation': ""Academic Unit of Child Health, Sheffield Children's Hospital, University of Sheffield, Sheffield, United Kingdom.""}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': ""Nuffield Department of Women's & Reproductive Health, John Radcliffe Hospital, University of Oxford, Oxford, United Kingdom.""}, {'ForeName': 'Aris T', 'Initials': 'AT', 'LastName': 'Papageorghiou', 'Affiliation': ""Nuffield Department of Women's & Reproductive Health, John Radcliffe Hospital, University of Oxford, Oxford, United Kingdom.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fraser', 'Affiliation': 'Department of Obstetrics and Gynaecology, Sheffield Hospitals National Health Service Trust, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Saurabh V', 'Initials': 'SV', 'LastName': 'Gandhi', 'Affiliation': 'Department of Obstetrics and Gynaecology, Sheffield Hospitals National Health Service Trust, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Prentice', 'Affiliation': 'Medical Research Council Nutrition and Bone Health, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Hazel M', 'Initials': 'HM', 'LastName': 'Inskip', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Inez', 'Initials': 'I', 'LastName': 'Schoenmakers', 'Affiliation': 'Department of Medicine, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'M Kassim', 'Initials': 'MK', 'LastName': 'Javaid', 'Affiliation': 'National Institute for Health Research Oxford Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Academic Unit of Bone Metabolism, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Harvey', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab264']
868,34297008,Direct Verbal Suggestibility as a Predictor of Placebo Hypoalgesia Responsiveness.,"OBJECTIVE


Reliably identifying good placebo responders has pronounced implications for basic research on, and clinical applications of, the placebo response. Multiple studies point to direct verbal suggestibility as a potentially valuable predictor of individual differences in placebo responsiveness, but previous research has produced conflicting results on this association.
METHODS


In two double-blind studies, we examined whether behavioral direct verbal suggestibility measures involving a correction for compliance would be associated with individual differences in responsiveness to conditioned and unconditioned placebo hypoalgesia using an established placebo analgesia paradigm. In study 1 (n = 57; mean [standard deviation] age = 23.7 [8.1] years; 77% women), we used behavioral hypnotic suggestibility as a predictor of placebo hypoalgesia induced through conditioning and verbal suggestion, whereas in study 2 (n = 78; mean [standard deviation] = 26.1 [7.4] years; 65% women), we measured nonhypnotic suggestibility and placebo hypoalgesia induced through verbal suggestion without conditioning.
RESULTS


In study 1, the placebo hypoalgesia procedure yielded a moderate placebo response (g = 0.63 [95% confidence interval = 0.32 to 0.97]), but the response magnitude did not significantly correlate with hypnotic suggestibility (rs = 0.11 [-0.17 to 0.37]). In study 2, the placebo procedure did not yield a significant placebo response across the full sample (g = 0.11 [-0.11 to 0.33]), but the magnitude of individual placebo responsiveness significantly correlated with nonhypnotic suggestibility (rs = 0.27 [0.03 to 0.48]).
CONCLUSIONS


These results suggest that the extent to which direct verbal suggestibility captures variability in placebo responsiveness depends on the use of conditioning and highlights the utility of suggestibility as a potential contributing factor to placebo responding when placebo hypoalgesia is induced through verbal suggestions.",2021,"In Study 2, the placebo procedure did not yield a significant placebo response across the full sample (g = 0.11","['In Study 1 (N = 57; MAge = 23.7, SD = 8.1; 77% women), we used behavioural hypnotic suggestibility as a predictor of placebo hypoalgesia induced through conditioning and verbal suggestion whereas in Study 2 (N = 78; MAge = 26.1, SD = 7.4; 65% women), we measured non-hypnotic suggestibility and placebo hypoalgesia induced through verbal suggestion without conditioning']",[],"['moderate placebo response', 'magnitude of individual placebo responsiveness', 'hypnotic suggestibility']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0233423', 'cui_str': 'Suggestibility'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0233423', 'cui_str': 'Suggestibility'}]",,0.235556,"In Study 2, the placebo procedure did not yield a significant placebo response across the full sample (g = 0.11","[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Parsons', 'Affiliation': 'From the Department of Psychology, Goldsmiths (Parsons, Bergmann, Terhune), University of London, London, United Kingdom; Department of Psychology (Parsons), University of Bath, Bath, England; and Wellcome Centre for Integrative Neuroimaging & Nuffield Department of Clinical Neurosciences (Wiech), University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bergmann', 'Affiliation': ''}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wiech', 'Affiliation': ''}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Terhune', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000977']
869,34293528,Electrophysiological predictors of response to subcutaneous immunoglobulin therapy in chronic inflammatory demyelinating polyneuropathy.,"OBJECTIVE


To assess axonal function prior to subcutaneous immunoglobulin (SCIG) therapy or placebo in relation to relapse in chronic inflammatory demyelinating polyneuropathy (CIDP) to determine whether axonal damage can predict therapy response.
METHODS


Relapse rates in patients from the Polyneuropathy and Treatment with Hizentra (PATH) study, where patients were treated with placebo or SCIG (IgPro20), were analyzed by baseline (post-intravenous immunoglobulin stabilization) axonal damage (≤1 mV peroneal compound muscle action potential) status.
RESULTS


In patients with non-axonal damage, relapses were significantly higher with placebo (73.0%) than IgPro20 (0.2 g/kg: 39.1%, 0.4 g/kg: 19.2%). In patients with axonal damage, IgPro20 had no effect on relapse (placebo: 25.0%, IgPro20: 0.2 g/kg: 30.0%, 0.4 g/kg: 19.4%). Patients with axonal damage relapsed significantly less on placebo versus non-axonal damage, but they also demonstrated higher baseline disability.
CONCLUSION


Axonal damage may correspond to relapse upon treatment withdrawal; patients with axonal damage relapse less, possibly reflecting poor response to immunoglobulin therapy, while non-axonal damage patients may experience more relapse, perhaps indicating better treatment response.
SIGNIFICANCE


In CIDP patients with axonal loss, immunoglobulin therapy may not be as effective. Assessing axonal damage could help guide therapy, with immunoglobulins ideally used before substantial axonal damage arises.",2021,"Patients with axonal damage relapsed significantly less on placebo versus non-axonal damage, but they also demonstrated higher baseline disability.
","['chronic inflammatory demyelinating polyneuropathy (CIDP', 'Relapse rates in patients from the Polyneuropathy and Treatment with Hizentra (PATH) study, where patients were treated with', 'chronic inflammatory demyelinating polyneuropathy']","['subcutaneous immunoglobulin (SCIG) therapy or placebo', 'placebo', 'placebo or SCIG (IgPro20', 'subcutaneous immunoglobulin therapy']",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}, {'cui': 'C0393819', 'cui_str': 'Chronic inflammatory demyelinating polyradiculoneuropathy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2746518', 'cui_str': 'Hizentra'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3181507', 'cui_str': 'IgPro20'}, {'cui': 'C0021022', 'cui_str': 'Immunoglobulin therapy'}]",[],,0.155955,"Patients with axonal damage relapsed significantly less on placebo versus non-axonal damage, but they also demonstrated higher baseline disability.
","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Alcantara', 'Affiliation': 'Ellen & Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Brain and Mind Centre, University of Sydney, Australia; Medical University of Vienna, Austria.'}, {'ForeName': 'John-Philip', 'Initials': 'JP', 'LastName': 'Lawo', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Billie L', 'Initials': 'BL', 'LastName': 'Durn', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Orell', 'Initials': 'O', 'LastName': 'Mielke', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'Ellen & Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Canada. Electronic address: vera.bril@utoronto.ca.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2021.05.018']
870,34246887,Does raising heart rate prior to a behavioural test enhance learning in cognitive therapy for anxiety? An experimental test for the treatment of fear of heights using virtual reality.,"BACKGROUND


A key clinical issue is how to maximise the belief change central to cognitive therapy. Physiological arousal is a key internal cue confirming threat beliefs in anxiety disorders. Deeper extinction of anxiety may occur if catastrophizing responses to physiological arousal are inhibited prior to joint exposure with external phobic stimuli. The aim of the study was to test whether increasing physiological arousal using exercise increases the benefits of behavioural tests.
METHODS


Sixty individuals with a fear of heights had one session of VR cognitive treatment. They were randomised to have the treatment either with periods of intense physical exercise (cycling at 80% of maximum heart rate) prior to exposures or without. Linear mixed effects models were used to check the manipulation and test the primary hypothesis of a group difference in degree of conviction in the phobic threat belief.
RESULTS


Heart rate was significantly higher in the exercise group throughout compared with the control group. Both groups showed significant reductions in threat beliefs after the VR treatment (d = 1.0, p < 0.001) but there was no significant group difference (d = 0.1, p = 0.56).
DISCUSSION


An increase in physiological arousal achieved via exercise did not enhance cognitive change in beliefs about feared stimuli.",2021,"Both groups showed significant reductions in threat beliefs after the VR treatment (d = 1.0, p < 0.001) but there was no significant group difference (d = 0.1, p = 0.56).
",['Sixty individuals with a fear of heights had one session of VR cognitive treatment'],['intense physical exercise'],"['Heart rate', 'threat beliefs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0233701', 'cui_str': 'Fear of heights'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",60.0,0.0266886,"Both groups showed significant reductions in threat beliefs after the VR treatment (d = 1.0, p < 0.001) but there was no significant group difference (d = 0.1, p = 0.56).
","[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'McInerney', 'Affiliation': 'Royal Holloway, University of London, UK; Broadmoor Hospital, West London NHS Trust, UK. Electronic address: josephine.mcinerney1@nhs.net.'}, {'ForeName': 'Poppy', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Oxford, UK.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Bird', 'Affiliation': 'Department of Psychiatry, University of Oxford, UK; Oxford Health NHS Foundation Trust, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'School of Chemistry, University of Bristol, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Brown', 'Affiliation': 'Royal Holloway, University of London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Oxford, UK; Oxford Health NHS Foundation Trust, UK.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103928']
871,34250947,Multifocal Noninvasive Magnetic Stimulation of the Primary Motor Cortex in Type 1 Myotonic Dystrophy -A Proof of Concept Pilot Study.,"BACKGROUND


Repeated neuromuscular electrical stimulation in type 1 Myotonic Dystrophy (DM1) has previously been shown to cause an increase in strength and a decrease in hyperexcitability of the tibialis anterior muscle.
OBJECTIVE


In this proof-of-principle study our objective was to test the hypothesis that noninvasive repetitive transcranial magnetic stimulation of the primary motor cortex (M1) with a new portable wearable multifocal stimulator causes improvement in muscle function in DM1 patients.
METHODS


We performed repetitive stimulation of M1, localized by magnetic resonance imaging, with a newly developed Transcranial Rotating Permanent Magnet Stimulator (TRPMS). Using a randomized within-patient placebo-controlled double-blind TRPMS protocol, we performed unilateral active stimulation along with contralateral sham stimulation every weekday for two weeks in 6 adults. Methods for evaluation of muscle function involved electromyography (EMG), hand dynamometry and clinical assessment using the Medical Research Council scale.
RESULTS


All participants tolerated the treatment well. While there were no significant changes clinically, EMG showed significant improvement in nerve stimulus-evoked compound muscle action potential amplitude of the first dorsal interosseous muscle and a similar but non-significant trend in the trapezius muscle, after a short exercise test, with active but not sham stimulation.
CONCLUSIONS


We conclude that two-week repeated multifocal cortical stimulation with a new wearable transcranial magnetic stimulator can be safely conducted in DM1 patients to investigate potential improvement of muscle strength and activity. The results obtained, if confirmed and extended by future safety and efficacy trials with larger patient samples, could offer a potential supportive TRPMS treatment in DM1.",2021,"While there were no significant changes clinically, EMG showed significant improvement in nerve stimulus-evoked compound muscle action potential amplitude of the first dorsal interosseous muscle and a similar but non-significant trend in the trapezius muscle, after a short exercise test, with active but not sham stimulation.
","['6 adults', 'DM1 patients']","['Transcranial Rotating Permanent Magnet Stimulator (TRPMS', 'placebo-controlled double-blind TRPMS protocol']",['nerve stimulus-evoked compound muscle action potential amplitude of the first dorsal interosseous muscle'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0024483', 'cui_str': 'Magnet'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0522028', 'cui_str': 'Muscle action potential'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",6.0,0.098371,"While there were no significant changes clinically, EMG showed significant improvement in nerve stimulus-evoked compound muscle action potential amplitude of the first dorsal interosseous muscle and a similar but non-significant trend in the trapezius muscle, after a short exercise test, with active but not sham stimulation.
","[{'ForeName': 'Ericka', 'Initials': 'E', 'LastName': 'Greene', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, Houston, Texas, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thonhoff', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, Houston, Texas, USA.'}, {'ForeName': 'Blessy S', 'Initials': 'BS', 'LastName': 'John', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, Houston, Texas, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Rosenfield', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, Houston, Texas, USA.'}, {'ForeName': 'Santosh A', 'Initials': 'SA', 'LastName': 'Helekar', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, Houston, Texas, USA.'}]",Journal of neuromuscular diseases,['10.3233/JND-210690']
872,34250945,Clinical Outcome Evaluations and CBT Response Prediction in Myotonic Dystrophy.,"BACKGROUND


The European OPTIMISTIC clinical trial has demonstrated a significant, yet heterogenous effect of Cognitive Behavioural Therapy (CBT) for Myotonic Dystrophy type 1 (DM1) patients. One of its remaining aims was the assessment of efficacy and adequacy of clinical outcome measures, including the relatively novel primary trial outcome, the DM1-Activ-c questionnaire.
OBJECTIVES


Assessment of the relationship between the Rasch-built DM1-Activ-c questionnaire and 26 commonly used clinical outcome measurements. Identification of variables associated with CBT response in DM1 patients.
METHODS


Retrospective analysis of the to date largest clinical trial in DM1 (OPTIMISTIC), comprising of 255 genetically confirmed DM1 patients randomized to either standard care or CBT with optionally graded exercise therapy. Correlations of 27 different outcome measures were calculated at baseline (cross-sectional) and of their respective intervention induced changes (longitudinal). Bootstrap enhanced Elastic-Net (BeEN) regression was validated and implemented to select variables associated with CBT response.
RESULTS


In cross-sectional data, DM1-Activ-c correlated significantly with the majority of other outcome measures, including Six Minute Walk Test and Myotonic Dystrophy Health Index. Fewer and weaker significant longitudinal correlations were observed. Nine variables potentially associated with CBT response were identified, including measures of disease severity, executive cognitive functioning and perceived social support.
CONCLUSIONS


The DM1-Activ-c questionnaire appears to be a well suited cross-sectional instrument to assess a variety of clinically relevant dimensions in DM1. Yet, apathy and experienced social support measures were less well captured. CBT response was heterogenous, requiring careful selection of outcome measures for different disease aspects.",2021,"Nine variables potentially associated with CBT response were identified, including measures of disease severity, executive cognitive functioning and perceived social support.
","['Retrospective analysis of the to date largest clinical trial in DM1 (OPTIMISTIC), comprising of 255 genetically confirmed DM1 patients randomized to either', 'DM1 patients']","['standard care or CBT with optionally graded exercise therapy', 'Cognitive Behavioural Therapy (CBT']","['disease severity, executive cognitive functioning and perceived social support', 'DM1-Activ-c questionnaire', 'Six Minute Walk Test and Myotonic Dystrophy Health Index', 'CBT response']","[{'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C2711962', 'cui_str': 'Graded exercise therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0027126', 'cui_str': 'Steinert myotonic dystrophy syndrome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",255.0,0.0696486,"Nine variables potentially associated with CBT response were identified, including measures of disease severity, executive cognitive functioning and perceived social support.
","[{'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'van As', 'Affiliation': 'Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Okkersen', 'Affiliation': 'Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bassez', 'Affiliation': 'Neuromuscular Reference Centre, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schoser', 'Affiliation': 'Friedrich-Baur-Institute, Department of Neurology, Klinikum der Universität München, Ludwig Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Hanns', 'Initials': 'H', 'LastName': 'Lochmüller', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada.""}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Glennon', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knoop', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Baziel G M', 'Initials': 'BGM', 'LastName': 'van Engelen', 'Affiliation': 'Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter A C', 'Initials': 'PAC', 'LastName': ""'t Hoen"", 'Affiliation': 'Center for Molecular and Biomolecular Informatics, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neuromuscular diseases,['10.3233/JND-210634']
873,34263424,Effects of Temperature and Position Change on Neonatal Brain Regional Oxygen Saturation in Tub Bathing: A Prospective Study.,"INTRODUCTION


A major goal in neonatal medicine is to reduce stress as much as possible in routine care. Bathing is one of the important routine cares for neonates, but it makes a big environmental change for them. We aimed to examine whether water temperature, room temperature, and position changes in tub bathing serve as noxious stimuli to neonates.
METHODS


This prospective trial was performed in full-term and non-low-birth-weight neonates admitted to the hospital between July 2020 and March 2021. Those with underlying diseases, fetal distress, infection, and other medical conditions were excluded. Measurements were taken during the neonates' first tub bath since birth, which was performed by a trained nurse. Changes in regional oxygen saturation (rSO 2 ), determined using near-infrared spectroscopy, and water and room temperature, were examined at five different time points: upon entering the bath, head washing, position change, exiting the bath, and during the 3 min after bathing.
RESULTS


In total, 17 neonates were analyzed. No changes in rSO 2  due to head washing or position change were observed; however, rSO 2  significantly decreased upon entering (78.5 ± 4.1% vs. 75.7 ± 4.1%, p < 0.001) and exiting the bath (75.8 ± 5.7% vs. 74.4 ± 5.4%, p < 0.04). The rate change in rSO 2  upon entering the bath showed a significant inverse correlation with water temperature (r =  - 0.53, p < 0.03), and there were no significant correlations between rSO 2  and water or room temperature upon exiting the bath. There was no change in body skin temperature before and after bathing, but rSO 2  gradually decreased during the 3 min after bathing.
CONCLUSIONS


Neonates may perceive certain temperatures during bathing as noxious stimuli. Therefore, methods to minimize stress associated with bathing should be implemented to reduce the difference between water temperature and room temperature during bathing.
TRIAL REGISTRATION


This trial has been registered at UMIN repository with the trial number UMIN000041045 ( https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046500 ). The date of the final dataset was April 01, 2021.",2021,"No changes in rSO 2  due to head washing or position change were observed; however, rSO 2  significantly decreased upon entering (78.5 ± 4.1% vs. 75.7 ± 4.1%, p < 0.001) and exiting the bath (75.8 ± 5.7% vs. 74.4 ± 5.4%, p < 0.04).","['Tub Bathing', 'full-term and non-low-birth-weight neonates admitted to the hospital between July 2020 and March 2021']",['Temperature and Position Change'],"['regional oxygen saturation (rSO 2 ), determined using near-infrared spectroscopy, and water and room temperature', 'body skin temperature', 'Neonatal Brain Regional Oxygen Saturation', 'water temperature', 'rSO 2  gradually']","[{'cui': 'C0518460', 'cui_str': 'Bathing'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0444793', 'cui_str': 'Position change'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",17.0,0.0501147,"No changes in rSO 2  due to head washing or position change were observed; however, rSO 2  significantly decreased upon entering (78.5 ± 4.1% vs. 75.7 ± 4.1%, p < 0.001) and exiting the bath (75.8 ± 5.7% vs. 74.4 ± 5.4%, p < 0.04).","[{'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Nishino', 'Affiliation': 'Department of Pediatrics, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8605, Japan. sinonosino@yahoo.co.jp.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ito', 'Affiliation': 'Department of Pediatrics, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8605, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tomori', 'Affiliation': 'Department of Pediatrics, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8605, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Shimada', 'Affiliation': 'Department of Pediatrics, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8605, Japan.'}, {'ForeName': 'Misaki', 'Initials': 'M', 'LastName': 'Kodera', 'Affiliation': 'Department of Pediatrics, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8605, Japan.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Morita', 'Affiliation': 'Department of Pediatrics, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8605, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Pediatrics, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8605, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Mimaki', 'Affiliation': 'Department of Pediatrics, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8605, Japan.'}]",Pain and therapy,['10.1007/s40122-021-00290-9']
874,34261911,"Safety and efficacy of spleen aminopeptide oral lyophilized powder for improving quality of life and immune response in patients with advanced breast cancer: a multicenter, randomized, double-blind, placebo-controlled clinical trial.","Health-related quality of life (HRQoL) is an important consideration in managing patients. Spleen aminopeptide oral lyophilized powder (SAOLP) has been used to enhance cellular immunity in a patient. This multicenter, randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the safety and efficacy of SAOLP for improving HRQoL in patients with breast cancer. Patients diagnosed with advanced breast cancer were included, and were administered SAOLP or placebo 4 mg qd for two cycles. The primary endpoint was improvement in HRQoL on day 42 measured by the EORTC QLQ-C30 and EORTC QLQ-BR23. Secondary endpoints included immunologic function, improvement in HRQoL on day 21 and 84, objective response rate, disease control rate, BMI and adverse events. On day 42, on the EORTC QLQ-C30 or EORTC QLQ-BR23, scores on the functional scales and QoL scale were significantly higher and scores on symptom scales were significantly lower in patients who received SAOLP compared to placebo (P < 0.05). On day 84, the number of CD3, CD4 and CD8 cells were significantly higher in patients who received SAOLP. There were no significant differences in objective response rate, disease control rate or BMI. SAOLP may improve HRQoL and the immune response in patients with advanced breast cancer, represents a convenient and safe adjuvant therapy.",2021,"On day 84, the number of CD3, CD4 and CD8 cells were significantly higher in patients who received SAOLP.","['Patients diagnosed with advanced breast cancer', 'patients with advanced breast cancer', 'patients with breast cancer']","['spleen aminopeptide oral lyophilized powder', 'SAOLP', 'SAOLP or placebo', 'placebo', 'Spleen aminopeptide oral lyophilized powder (SAOLP']","['objective response rate, disease control rate or BMI', 'immunologic function, improvement in HRQoL on day 21 and 84, objective response rate, disease control rate, BMI and adverse events', 'symptom scales', 'quality of life and immune response', 'safety and efficacy', 'EORTC QLQ-C30 or EORTC QLQ-BR23, scores on the functional scales and QoL scale', 'HRQoL on day 42 measured by the EORTC QLQ-C30 and EORTC QLQ-BR23', 'number of CD3, CD4 and CD8 cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2981265', 'cui_str': 'Lyophilized powder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}]",,0.535307,"On day 84, the number of CD3, CD4 and CD8 cells were significantly higher in patients who received SAOLP.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Shang', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Zhongjun', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Bangwei', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': ''}]",Anti-cancer drugs,['10.1097/CAD.0000000000001109']
875,34266897,Suppressing the Morning Cortisol Rise After Memory Reactivation at 4 A.M. enhances Episodic Memory Reconsolidation in Humans.,"Evidence from animal and human research shows that established memories can undergo changes after reactivation through a process called reconsolidation. Alterations of the level of the stress hormone cortisol may provide a way to manipulate reconsolidation in humans. Here, in a double-blind, within-subject design, we reactivated a 3-d-old memory at 3:55 A.M. in sixteen men and four women, immediately followed by oral administration of metyrapone versus placebo, to examine whether metyrapone-induced suppression of the morning cortisol rise may influence reconsolidation processes during and after early morning sleep. Crucially, reactivation followed by cortisol suppression versus placebo resulted in enhanced memory for the reactivated episode tested 4 d after reactivation. This enhancement after cortisol suppression was specific for the reactivated episode versus a non-reactivated episode. These findings suggest that when reactivation of memories is immediately followed by suppression of cortisol levels during early morning sleep in humans, reconsolidation processes change in a way that leads to the strengthening of episodic memory traces. SIGNIFICANCE STATEMENT  How can we change formed memories? Modulation of established memories has been long debated in cognitive neuroscience and remains a crucial question to address for basic and clinical research. Stress-hormone cortisol and sleep are strong candidates for changing consolidated memories. In this double-blind, placebo-controlled, within-subject pharmacological study, we investigate the role of cortisol on the modulation of reconsolidation of episodic memories in humans. Blocking cortisol synthesis (3 g metyrapone) during early morning sleep boosts memory for a reactivated but not for a non-reactivated story. This finding contributes to our understanding of the modulatory role of cortisol and its circadian variability on reconsolidation, and moreover can critically inform clinical interventions for the case of memory dysfunctions, and trauma and stress-related disorders.",2021,"Crucially, reactivation followed by cortisol suppression vs. placebo resulted in enhanced memory for the reactivated episode tested four days after reactivation.",['humans'],"['metyrapone vs. placebo', 'placebo']","['Blocking cortisol synthesis', 'Stress-hormone cortisol and sleep']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0025876', 'cui_str': 'Metyrapone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",16.0,0.128132,"Crucially, reactivation followed by cortisol suppression vs. placebo resulted in enhanced memory for the reactivated episode tested four days after reactivation.","[{'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Antypa', 'Affiliation': 'Laboratory of Neurology and Imaging of Cognition, Department of Basic Neurosciences, University of Geneva, Geneva CH-1203, Switzerland.'}, {'ForeName': 'Aurore A', 'Initials': 'AA', 'LastName': 'Perrault', 'Affiliation': 'Swiss Center of Affective Sciences, University of Geneva, Geneva CH-1203, Switzerland.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Vuilleumier', 'Affiliation': 'Laboratory of Neurology and Imaging of Cognition, Department of Basic Neurosciences, University of Geneva, Geneva CH-1203, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'Swiss Center of Affective Sciences, University of Geneva, Geneva CH-1203, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Rimmele', 'Affiliation': 'Laboratory of Neurology and Imaging of Cognition, Department of Basic Neurosciences, University of Geneva, Geneva CH-1203, Switzerland ulrike.rimmele@unige.ch.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.0096-21.2021']
876,34265015,Strengthening the success rate of suprapubic aspiration in infants by integrating point-of-care ultrasonography guidance: A parallel-randomized clinical trial.,"BACKGROUND


Urinary tract infection (UTI) is a common disease in childhood. A sterile collection of urine samples using suprapubic aspiration (SPA) and bladder catheterization (BC) is helpful for rapid and accurate diagnosis of UTI in infants. With the advent of point-of-care ultrasound (POCUS), the use of ultrasound by non-radiologists at the patient's bedside, great advancement has been noticed in various medical fields. Considering the importance and advantages of using POCUS in the physical examination and guiding procedures, the authors aimed to compare urine sampling's success rate by SPA, BC, and POCUS guided SPA (POCUS-SPA) in infants performed by three pediatricians.
MATERIALS AND METHODS


This study is a randomized clinical trial conducted on 114 neonates and infants with suspected UTI admitted to 17-Shahrivar children's hospital from April 2017 to September 2019. Neonates and infants were randomly assigned to three groups of BC, SPA, and POCUS-SPA. The primary outcome was the success of sampling defined by obtaining 1cc of urine in each method. The secondary outcome was assessing the pain level.
RESULTS


Results showed that the POCUS-SPA had the highest success rate in urine sampling, and a statistically significant relation was noted among the three groups (P = 0.0001). From 38 patients in each group, 37 patients of POCUS-SPA (97.4%), 34 patients of BC (89.5%), and 23 patients of SPA (60.5%) had a successful sampling. Most of the patients in all three groups experienced severe pain.
CONCLUSIONS


In the current study, results showed that the POCUS-SPA significantly increased the success rate of urine sampling and most of the patients in all three groups had severe pain. Based on the shortage of access to radiologists in emergency setups, it seems that the POCUS-SPA by the pediatricians can be one of the most appropriate and applicable diagnostic methods in infants with UTI.",2021,"RESULTS


Results showed that the POCUS-SPA had the highest success rate in urine sampling, and a statistically significant relation was noted among the three groups (P = 0.0001).","['Neonates and infants', 'infants with UTI', ""114 neonates and infants with suspected UTI admitted to 17-Shahrivar children's hospital from April 2017 to September 2019""]","['point-of-care ultrasound (POCUS', 'suprapubic aspiration', 'suprapubic aspiration (SPA) and bladder catheterization (BC']","['pain level', 'severe pain', 'success rate of urine sampling', 'success of sampling defined by obtaining 1cc of urine in each method']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C1277624', 'cui_str': 'Suspected UTI (urinary tract infection)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205498', 'cui_str': 'Suprapubic approach'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0042019', 'cui_str': 'Catheterization, Urinary'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",114.0,0.143406,"RESULTS


Results showed that the POCUS-SPA had the highest success rate in urine sampling, and a statistically significant relation was noted among the three groups (P = 0.0001).","[{'ForeName': 'Sadroddin', 'Initials': 'S', 'LastName': 'Mahdipour', 'Affiliation': 'Neonatologist, Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Seyedeh Nastaran Seyed', 'Initials': 'SNS', 'LastName': 'Saadat', 'Affiliation': 'Pediatrician, Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Badeli', 'Affiliation': 'Pediatric Nephrologist, Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Afagh Hassanzadeh', 'Initials': 'AH', 'LastName': 'Rad', 'Affiliation': 'BS of Midwifery, PhD of Linguistics, Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}]",PloS one,['10.1371/journal.pone.0254703']
877,34265007,"Pilot study of extended-release lorcaserin for cocaine use disorder among men who have sex with men: A double-blind, placebo-controlled randomized trial.","OBJECTIVE


To determine if men who have sex with men (MSM) with cocaine use disorder (CUD) and actively-using cocaine could be enrolled and retained in a pharmacologic intervention trial of lorcaserin-a novel 5-HT2cR agonist-and determine the degree to which participants would adhere to study procedures.
METHODS


This was a phase II randomized, double-blind, placebo-controlled pilot study with 2:1 random parallel group assignment to daily extended-release oral lorcaserin 20 mg versus placebo (clinicaltrials.gov identifier-NCT03192995). Twenty-two of a planned 45 cisgender MSM with CUD were enrolled and had weekly follow-up visits during a 12-week treatment period, with substance use counseling, urine specimen collection, and completion of audio-computer assisted self-interview (ACASI) behavioral risk assessments. Adherence was measured by medication event monitoring systems (MEMS) caps and self-report. This study was terminated early because of an FDA safety alert for lorcaserin's long-term use.
RESULTS


Eighty-six percent completed the trial, with 82% of weekly study follow-up visits completed. Adherence was 55.3% (lorcaserin 51.6% vs. placebo 66.2%) by MEMS cap and 56.9% (56.5% vs. placebo 57.9%) by self-report and did not differ significantly by treatment assignment. Intention-to-treat analyses (ITT) did not show differences in cocaine positivity by urine screen between the lorcaserin and placebo groups by 12 week follow-up (incidence risk ratio [IRR]: 0.96; 95%CI = 0.24-3.82, P = 0.95). However, self-reported cocaine use in timeline follow-back declined more significantly in the lorcaserin group compared to placebo (IRR: 0.66; 95%CI = 0.49-0.88; P = 0.004).
CONCLUSION


We found that it is feasible, acceptable, and tolerable to conduct a placebo-controlled pharmacologic trial for MSM with CUD who are actively using cocaine. Lorcaserin was not associated with significant reductions in cocaine use by urine testing, but was associated with significant reductions in self-reported cocaine use. Future research may be needed to continue to explore the potential utility of 5-HT2cR agonists.",2021,"Intention-to-treat analyses (ITT) did not show differences in cocaine positivity by urine screen between the lorcaserin and placebo groups by 12 week follow-up (incidence risk ratio [IRR]: 0.96; 95%CI = 0.24-3.82, P = 0.95).","['Twenty-two of a planned 45 cisgender MSM with CUD were enrolled and had weekly follow-up visits during a 12-week treatment period, with', 'men who have sex with men (MSM) with cocaine use disorder (CUD) and actively-using', 'men who have sex with men', 'Eighty-six percent completed the trial, with 82% of weekly study follow-up visits completed']","['cocaine', 'extended-release lorcaserin', 'placebo', 'daily extended-release oral lorcaserin', 'substance use counseling, urine specimen collection, and completion of audio-computer assisted self-interview (ACASI) behavioral risk assessments']","['cocaine positivity by urine screen', 'Adherence']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.506913,"Intention-to-treat analyses (ITT) did not show differences in cocaine positivity by urine screen between the lorcaserin and placebo groups by 12 week follow-up (incidence risk ratio [IRR]: 0.96; 95%CI = 0.24-3.82, P = 0.95).","[{'ForeName': 'Glenn-Milo', 'Initials': 'GM', 'LastName': 'Santos', 'Affiliation': 'Department of Community Health Systems, University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ikeda', 'Affiliation': 'Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Coffin', 'Affiliation': 'Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Walker', 'Affiliation': 'Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Matheson', 'Affiliation': 'Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McLaughlin', 'Affiliation': 'Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jain', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Batki', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, CA, United States of America.'}]",PloS one,['10.1371/journal.pone.0254724']
878,34264994,In vivo mitochondrial ATP production is improved in older adult skeletal muscle after a single dose of elamipretide in a randomized trial.,"BACKGROUND


Loss of mitochondrial function contributes to fatigue, exercise intolerance and muscle weakness, and is a key factor in the disability that develops with age and a wide variety of chronic disorders. Here, we describe the impact of a first-in-class cardiolipin-binding compound that is targeted to mitochondria and improves oxidative phosphorylation capacity (Elamipretide, ELAM) in a randomized, double-blind, placebo-controlled clinical trial.
METHODS


Non-invasive magnetic resonance and optical spectroscopy provided measures of mitochondrial capacity (ATPmax) with exercise and mitochondrial coupling (ATP supply per O2 uptake; P/O) at rest. The first dorsal interosseous (FDI) muscle was studied in 39 healthy older adult subjects (60 to 85 yrs of age; 46% female) who were enrolled based on the presence of poorly functioning mitochondria. We measured volitional fatigue resistance by force-time integral over repetitive muscle contractions.
RESULTS


A single ELAM dose elevated mitochondrial energetic capacity in vivo relative to placebo (ΔATPmax; P = 0.055, %ΔATPmax; P = 0.045) immediately after a 2-hour infusion. No difference was found on day 7 after treatment, which is consistent with the half-life of ELAM in human blood. No significant changes were found in resting muscle mitochondrial coupling. Despite the increase in ATPmax there was no significant effect of treatment on fatigue resistance in the FDI.
CONCLUSIONS


These results highlight that ELAM rapidly and reversibly elevates mitochondrial capacity after a single dose. This response represents the first demonstration of a pharmacological intervention that can reverse mitochondrial dysfunction in vivo immediately after treatment in aging human muscle.",2021,"RESULTS


A single ELAM dose elevated mitochondrial energetic capacity in vivo relative to placebo (ΔATPmax; P = 0.055, %ΔATPmax; P = 0.045) immediately after a 2-hour infusion.",['39 healthy older adult subjects (60 to 85 yrs of age; 46% female) who were enrolled based on the presence of poorly functioning mitochondria'],"['ELAM', 'placebo']","['fatigue resistance', 'resting muscle mitochondrial coupling', 'mitochondrial energetic capacity', 'mitochondrial capacity (ATPmax', 'volitional fatigue resistance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}]","[{'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}]",39.0,0.376816,"RESULTS


A single ELAM dose elevated mitochondrial energetic capacity in vivo relative to placebo (ΔATPmax; P = 0.055, %ΔATPmax; P = 0.045) immediately after a 2-hour infusion.","[{'ForeName': 'Baback', 'Initials': 'B', 'LastName': 'Roshanravan', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of California Davis, Sacramento, California, United States of America.'}, {'ForeName': 'Sophia Z', 'Initials': 'SZ', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Amir S', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Department of Radiology, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Eric G', 'Initials': 'EG', 'LastName': 'Shankland', 'Affiliation': 'Department of Radiology, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Chessa', 'Initials': 'C', 'LastName': 'Goss', 'Affiliation': 'Institute of Translational Health Sciences, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Amory', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'H Thomas', 'Initials': 'HT', 'LastName': 'Robertson', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Marcinek', 'Affiliation': 'Department of Radiology, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Conley', 'Affiliation': 'Department of Radiology, University of Washington, Seattle, Washington, United States of America.'}]",PloS one,['10.1371/journal.pone.0253849']
879,34268680,Supervised Exercise Immediately After Bariatric Surgery: the Study Protocol of the EFIBAR Randomized Controlled Trial.,"BACKGROUND


Previous studies have investigated weight loss caused by exercise following bariatric surgery. However, in most cases, the training program is poorly reported; the exercise type, volume, and intensity are briefly mentioned; and the sample size, selection criteria, and follow-up time vary greatly across studies.
PURPOSE


The EFIBAR study aims to investigate over 1 year the effects of a 16-week supervised exercise program, initiated immediately after bariatric surgery, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, and quality of life in patients with severe/extreme obesity.
MATERIAL AND METHODS


The EFIBAR study is a parallel-group, superiority, randomized controlled trial (RCT), comprising 80 surgery patients. Half of the participants, randomly selected, perform a 16-week supervised exercise program, including both strength and aerobic training, starting immediately after the surgery (7-14 days). For each participant, all primary and secondary outcomes are measured at three different time points: (i) before the surgery, (ii) after the intervention (≈4 months), and (iii) 1 year after the surgery.
CONCLUSION


The EFIBAR study will provide new insights into the multidimensional benefits of exercise in adults with severe/extreme obesity following bariatric surgery.
TRIAL REGISTRATION


EFIBAR randomized controlled trial was prospectively registered at Clinicaltrials.gov (NCT03497546) on April 13, 2018.",2021,"The EFIBAR study will provide new insights into the multidimensional benefits of exercise in adults with severe/extreme obesity following bariatric surgery.
","['80 surgery patients', 'patients with severe/extreme obesity', 'adults with severe/extreme obesity following bariatric surgery']","['supervised exercise program', 'Supervised Exercise', 'supervised exercise program, including both strength and aerobic training', 'Bariatric Surgery']","['weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, and quality of life']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",80.0,0.184359,"The EFIBAR study will provide new insights into the multidimensional benefits of exercise in adults with severe/extreme obesity following bariatric surgery.
","[{'ForeName': 'Enrique G', 'Initials': 'EG', 'LastName': 'Artero', 'Affiliation': 'Department of Education, Faculty of Education Sciences; SPORT Research Group (CTS-1024), CERNEP Research Centre, University of Almería, Almería, Spain. artero@ual.es.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ferrez-Márquez', 'Affiliation': 'General and Bariatric Surgery Unit, Torrecárdenas University Hospital, Almería, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Torrente-Sánchez', 'Affiliation': 'Hospital Mediterráneo, Almería, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Martínez-Rosales', 'Affiliation': 'Department of Education, Faculty of Education Sciences; SPORT Research Group (CTS-1024), CERNEP Research Centre, University of Almería, Almería, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Carretero-Ruiz', 'Affiliation': 'Department of Education, Faculty of Education Sciences; SPORT Research Group (CTS-1024), CERNEP Research Centre, University of Almería, Almería, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Hernández-Martínez', 'Affiliation': 'Department of Education, Faculty of Education Sciences; SPORT Research Group (CTS-1024), CERNEP Research Centre, University of Almería, Almería, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-Sánchez', 'Affiliation': 'Department of Education, Faculty of Education Sciences; SPORT Research Group (CTS-1024), CERNEP Research Centre, University of Almería, Almería, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Esteban-Simón', 'Affiliation': 'Department of Education, Faculty of Education Sciences; SPORT Research Group (CTS-1024), CERNEP Research Centre, University of Almería, Almería, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Romero Del Rey', 'Affiliation': 'Pediatric Unit, Torrecárdenas University Hospital, Almería, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Alcaraz-Ibáñez', 'Affiliation': 'Department of Education and Health Research Centre, University of Almería, Almería, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Rodríguez-Pérez', 'Affiliation': 'Department of Education, Faculty of Education Sciences; SPORT Research Group (CTS-1024), CERNEP Research Centre, University of Almería, Almería, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Villa-González', 'Affiliation': 'PROFITH Promoting Fitness and Health through Physical Activity Research Group, Department of Physical and Sports Education, Faculty of Education and Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Melilla, Spain.'}, {'ForeName': 'Yaira', 'Initials': 'Y', 'LastName': 'Barranco-Ruiz', 'Affiliation': 'PROFITH Promoting Fitness and Health through Physical Activity Research Group, Department of Physical and Sports Education, Faculty of Education and Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Melilla, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Martínez-Forte', 'Affiliation': 'Obstetrics and Gynecology Unit, Torrecárdenas University Hospital, Almería, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Castillo', 'Affiliation': 'Department of Economics and Business, SPORT Research Group (CTS-1024), CERNEP Research Centre, University of Almería, Almería, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gómez Navarro', 'Affiliation': 'Unit of Cardiology, Torrecárdenas University Hospital, Almería, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Aceituno Cubero', 'Affiliation': 'Unit of Cardiology, Torrecárdenas University Hospital, Almería, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Reyes Parrilla', 'Affiliation': 'Unit of Cardiology, Torrecárdenas University Hospital, Almería, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Aparicio Gómez', 'Affiliation': 'Unit of Cardiology, Torrecárdenas University Hospital, Almería, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Femia', 'Affiliation': 'Department of Statistics and Operations Research, Faculty of Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Fernández-Alonso', 'Affiliation': 'Obstetrics and Gynecology Unit, Torrecárdenas University Hospital, Almería, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Soriano-Maldonado', 'Affiliation': 'Department of Education, Faculty of Education Sciences; SPORT Research Group (CTS-1024), CERNEP Research Centre, University of Almería, Almería, Spain.'}]",Obesity surgery,['10.1007/s11695-021-05559-8']
880,34273115,Be under your own influence: Effectiveness of a Culturally-Adapted drug prevention campaign targeting Reservation-Dwelling American Indian youth.,"Be Under Your Own Influence (BUYOI) is a previously validated school-based intervention designed to delay adolescent substance use (SU) initiation. This study examined the effectiveness of a culturally-adapted version of BUYOI in delaying SU initiation among reservation-dwelling American Indian (AI) youth. Five reservation-based middle schools participated. Three schools were randomly assigned to receive BUYOI-AI (N = 321), and two schools served as controls (N = 176). Beginning in 7th grade, all participating students completed four assessments over the study period. Discrete time hazard models estimated the effects of BUYOI on students' risk of initiating alcohol, alcohol intoxication and marijuana before the end of 8th grade. AI students exposed to BUYOI had a lower risk of initiating alcohol use or intoxication, though sex moderated the effect on intoxication. These findings provide preliminary support for the effectiveness of a culturally-adapted version of BUYOI in delaying AI youth's first-time alcohol use and intoxication.",2021,Be Under Your Own Influence (BUYOI) is a previously validated school-based intervention designed to delay adolescent substance use (SU) initiation.,"['Five reservation-based middle schools participated', 'Dwelling American Indian youth', 'reservation-dwelling American Indian (AI) youth']","['Culturally-Adapted drug prevention campaign targeting Reservation', 'culturally-adapted version of BUYOI in delaying SU initiation']",['lower risk of initiating alcohol use or intoxication'],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}]",,0.0105889,Be Under Your Own Influence (BUYOI) is a previously validated school-based intervention designed to delay adolescent substance use (SU) initiation.,"[{'ForeName': 'Meghan A', 'Initials': 'MA', 'LastName': 'Crabtree', 'Affiliation': 'Department of Psychology, Tri-Ethnic Center for Prevention Research, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Stanley', 'Affiliation': 'Department of Psychology, Tri-Ethnic Center for Prevention Research, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Kelly', 'Affiliation': 'Department of Marketing, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Swaim', 'Affiliation': 'Department of Psychology, Tri-Ethnic Center for Prevention Research, Colorado State University, Fort Collins, Colorado, USA.'}]",Journal of community psychology,['10.1002/jcop.22672']
881,34273257,Pharmacokinetics and Use-Testing of Apalutamide Prepared in Aqueous Food Vehicles for Alternative Administration.,"Patients may have difficulty swallowing a whole daily dose of 240 mg (4 × 60-mg tablets) of apalutamide. One of the unique properties of apalutamide tablets is easy disintegration and dispersion when mixed into aqueous vehicles, avoiding the need to crush/split the tablets. To evaluate whether this method of apalutamide tablet administration would be conducive in a patient setting, different variations in preparation were evaluated, and one preparation was tested in humans. In vitro compatibility studies evaluated purity, dose, or stability of different variations of apalutamide in applesauce/yogurt/orange juice/green tea. An open-label, randomized, crossover phase 1 study in healthy men determined the bioavailability of an apalutamide-applesauce mixture versus whole tablets based on maximum plasma analyte concentration (C max  ), area under the plasma analyte concentration-time curve: AUC 0-72h  and AUC 0-168h  . Different amounts of applesauce/yogurt/orange juice/green tea as well as durations (up to 6 hours) did not affect the total apalutamide content available. The phase 1 study (n = 12) showed increased total exposure of 5% and peak exposure of 27.6% when comparing the apalutamide-applesauce mixture with whole-tablet administration. Variations in preparation times and total content for applesauce/yogurt/orange juice/green tea did not affect the purity, dose, or stability of apalutamide. An apalutamide-applesauce mixture is a suitable alternative administration method to whole tablets.",2021,"Variations in preparation times and total content for applesauce/yogurt/orange juice/green tea did not affect the purity, dose, or stability of apalutamide.",['healthy men'],['apalutamide'],"['maximum plasma analyte concentration (C max  ), area under the plasma analyte concentration-time curve: AUC', 'total exposure of 5% and peak exposure', 'purity, dose, or stability of apalutamide']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0443354', 'cui_str': 'Analyte'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}]",,0.0394172,"Variations in preparation times and total content for applesauce/yogurt/orange juice/green tea did not affect the purity, dose, or stability of apalutamide.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Yu', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen Research & Development, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Erba', 'Affiliation': 'CMC Leadership SMPD, Janssen Research & Development, Latina, Italy.'}, {'ForeName': 'Anasuya', 'Initials': 'A', 'LastName': 'Hazra', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen Research & Development, Spring House, Pennsylvania, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1001']
882,34283294,Relationship between retinal fluid and visual acuity in patients with exudative age-related macular degeneration treated with intravitreal aflibercept using a treat-and-extend regimen: subgroup and post-hoc analyses from the ALTAIR study.,"PURPOSE


To explore the relationship between retinal fluid status and best-corrected visual acuity (BCVA) in patients treated with intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) in the ALTAIR study.
METHODS


Outcomes were investigated according to overall fluid status at week 16 (predefined) and the relationship between any fluid, intraretinal fluid (IRF), subretinal fluid (SRF), or pigment epithelial detachment with BCVA at baseline, and weeks 16, 52, and 96 (post-hoc). The analyses involved treatment-naïve patients (N = 246) with exudative age-related macular degeneration (AMD), aged ≥ 50 years with BCVA of 73-25 Early Treatment Diabetic Retinopathy Study letters, who participated in the ALTAIR study.
RESULTS


The mean (standard deviation) change in BCVA from baseline to week 52 was + 10.6 (10.9) and + 6.5 (16.0) letters in patients without and with fluid at week 16, respectively; and to week 96 was + 9.1 (14.3) and + 4.3 (16.1) letters in patients without and with fluid at week 16, respectively. The last injection interval was 16 weeks in 33.6% and 2.0% (week 52), and 62.9% and 17.6% (week 96) of patients without or with fluid at week 16, respectively. At baseline, 35.7% of patients had IRF and 85.2% of patients had SRF, which decreased to 11.8% (IRF) and 31.7% (SRF) of patients, 8.5% (IRF) and 18.7% (SRF), and 6.5% (IRF) and 20.7% (SRF) at weeks 16, 52, and 96, respectively. Presence of IRF at all timepoints was associated with poorer BCVA than if IRF was absent, while the presence of SRF was not associated with poorer BCVA compared with the absence of SRF.
CONCLUSION


IVT-AFL T&E dosing was effective at clearing fluid regardless of fluid type in ~ 80% of patients with exudative AMD. Patients without fluid at week 16 had numerically better BCVA than those with fluid at week 16. Over 60% of patients without fluid at week 16 achieved the maximum treatment interval of 16 weeks by study end, compared with < 20% of patients with fluid at week 16. IRF (weeks 16, 52, 96), although evident in a small number of patients, was associated with poorer BCVA, whereas SRF was not.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02305238.",2021,Patients without fluid at week 16 had numerically better BCVA than those with fluid at week 16.,"['patients with exudative age-related macular degeneration treated with', 'naïve patients (N\u2009=\u2009246) with exudative age-related macular degeneration (AMD), aged\u2009≥', 'patients treated with intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) in the ALTAIR study', '50\xa0years with BCVA of 73-25 Early Treatment Diabetic Retinopathy Study letters, who participated in the ALTAIR study']","['IVT-AFL T&E', 'intravitreal aflibercept']","['mean (standard deviation) change in BCVA', 'retinal fluid status and best-corrected visual acuity (BCVA', 'relationship between any fluid, intraretinal fluid (IRF), subretinal fluid (SRF), or pigment epithelial detachment with BCVA', 'IRF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0339546', 'cui_str': 'Retinal pigment epithelial detachment'}]",246.0,0.343508,Patients without fluid at week 16 had numerically better BCVA than those with fluid at week 16.,"[{'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ohji', 'Affiliation': 'Department of Ophthalmology, Shiga University of Medical Science, Shiga, Japan. eye.ohji@gmail.com.'}, {'ForeName': 'Annabelle A', 'Initials': 'AA', 'LastName': 'Okada', 'Affiliation': 'Department of Ophthalmology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Bayer Yakuhin Ltd., Osaka, Japan.'}, {'ForeName': 'SungChul Charles', 'Initials': 'SC', 'LastName': 'Moon', 'Affiliation': 'Bayer Yakuhin Ltd., Osaka, Japan.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Machewitz', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Kanji', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Ophthalmology, Kansai Medical University, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-021-05293-y']
883,34291957,Initial efficacy of a web-based alcohol and emotion regulation intervention for college women with sexual assault histories.,"OBJECTIVE


College women with sexual assault histories report greater heavy drinking relative to those without histories of assault. Moreover, individuals with sexual assault histories often have difficulty regulating emotions and tolerating distress, which can lead to a problematic pattern of drinking to cope. Thus, we evaluated the initial efficacy of a web-based alcohol intervention that included strategies to reduce drinking and improve regulatory skills for heavy drinking college women with sexual assault histories.
METHOD


The sample comprised college women ( N  = 200) who were 20.9 ( SD  = 2.8) years old and primarily White (69%). They were randomized to an assessment-only control or intervention and completed 14 daily diary assessments, pre- and posttreatment surveys, and 1- and 6-month follow-up surveys. During daily diary, the intervention group received a brief (5-10 min) alcohol reduction or regulatory skill module each day.
RESULTS


Reductions in drinking quantity and heavy episodic drinking were found for the intervention group at posttreatment and 1-month follow-up relative to controls. Improved regulatory skills and reduced posttraumatic stress disorder (PTSD) symptoms were reported at posttreatment for women who received the intervention compared to controls. Although gains were maintained, the intervention group no longer differed from controls by 6-month follow-up.
CONCLUSIONS


Results suggest this web-based intervention may result in short-term reductions in drinking and PTSD symptoms as well as improvements in regulatory abilities for college women with sexual assault histories. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"RESULTS


Reductions in drinking quantity and heavy episodic drinking were found for the intervention group at posttreatment and 1-month follow-up relative to controls.","['College women with sexual assault histories report greater heavy drinking relative to those without histories of assault', 'college women with sexual assault histories', 'heavy drinking college women with sexual assault histories', 'sample comprised college women ( N  = 200) who were 20.9 ( SD  = 2.8) years old and primarily White (69']","['web-based alcohol intervention', 'brief (5-10 min) alcohol reduction or regulatory skill module each day', 'web-based alcohol and emotion regulation intervention']","['regulatory abilities', 'drinking quantity and heavy episodic drinking', 'Improved regulatory skills and reduced posttraumatic stress disorder (PTSD) symptoms', 'Initial efficacy']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.00906157,"RESULTS


Reductions in drinking quantity and heavy episodic drinking were found for the intervention group at posttreatment and 1-month follow-up relative to controls.","[{'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Stappenbeck', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Natasha K', 'Initials': 'NK', 'LastName': 'Gulati', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Jaffe', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Blayney', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000762']
884,34298279,"Intranasal oxytocin, testosterone reactivity, and human competitiveness.","Competitiveness is an essential feature of human social interactions. Despite an extensive body of research on the underlying psychological and cultural factors regulating competitive behavior, the role of biological factors remains poorly understood. Extant research has focused primarily on sex hormones, with equivocal findings. Here, we examined if intranasal administration of the neuropeptide oxytocin (OT) - a key regulator of human social behavior and cognition - interacts with changes in endogenous testosterone (T) levels in regulating the willingness to engage in competition. In a double-blind placebo-control design, 204 subjects (102 females) self-administrated OT or placebo and were assessed for their willingness to compete via an extensively-validated economic laboratory competition paradigm, in which, before completing a set of incentivized arithmetic tasks, subjects are asked to decide what percentage of their payoffs will be based on tournament paying-scheme. Salivary T concentrations (n = 197) were measured throughout the task to assess endogenous reactivity. Under both OT and placebo, T-reactivity during competition was not associated with competitiveness in females. However, in males, the association between T-reactivity and competitiveness was OT-dependent. That is, males under placebo demonstrated a positive correlation between T-reactivity and the willingness to engage in competition, while no association was observed in males receiving OT. The interaction between OT, T-reactivity, and sex on competitive preferences remained significant even after controlling for potential mediators such as performance, self-confidence, and risk-aversion, suggesting that this three-way interaction effect was specific to competitive motivation rather than to other generalized processes. These findings deepen our understanding of the biological processes underlying human preferences for competition and extend the evidence base for the interplay between hormones in affecting human social behavior.",2021,"Under both OT and placebo, T-reactivity during competition was not associated with competitiveness in females.",['204 subjects (102 females'],"['self-administrated OT or placebo', 'neuropeptide oxytocin (OT', 'placebo', 'OT and placebo']","['Salivary T concentrations', 'Intranasal oxytocin, testosterone reactivity, and human competitiveness', 'endogenous testosterone (T) levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]",197.0,0.0747096,"Under both OT and placebo, T-reactivity during competition was not associated with competitiveness in females.","[{'ForeName': 'Boaz R', 'Initials': 'BR', 'LastName': 'Cherki', 'Affiliation': 'Psychology Department, The Hebrew University of Jerusalem, Mount Scopus Campus, Mt. Scopus, Jerusalem 9190501, Israel; The Federmann Center for the Study of Rationality, The Hebrew University of Jerusalem, Edmond Safra Campus, Givat Ram, Jerusalem 9190401, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Winter', 'Affiliation': 'The Federmann Center for the Study of Rationality, The Hebrew University of Jerusalem, Edmond Safra Campus, Givat Ram, Jerusalem 9190401, Israel; Economics Department, The Hebrew University of Jerusalem, Mount Scopus Campus, Mt. Scopus, Jerusalem 9190501, Israel; Management School, University of Lancaster, Lancaster LA1 4YX, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mankuta', 'Affiliation': 'Hadassah Medical Center, Department of Labor and Delivery, Kiryat Hadassah, Jerusalem 9112001, Israel.'}, {'ForeName': 'Salomon', 'Initials': 'S', 'LastName': 'Israel', 'Affiliation': 'Psychology Department, The Hebrew University of Jerusalem, Mount Scopus Campus, Mt. Scopus, Jerusalem 9190501, Israel. Electronic address: salomon.israel@mail.huji.ac.il.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105352']
885,34298005,Prenatal and Postnatal Household Air Pollution Exposures and Pneumonia Risk: Evidence From the Ghana Randomized Air Pollution and Health Study.,"BACKGROUND


Nearly 40% of the world's population is exposed daily to household air pollution. The relative impact of prenatal and postnatal household air pollution exposure on early childhood pneumonia, a leading cause of mortality, is unknown.
RESEARCH QUESTION


Are prenatal or postnatal household air pollution, or both, associated with pneumonia risk in the first year of life?
STUDY DESIGN AND METHODS


The Ghana Randomized Air Pollution and Health Study enrolled 1,414 nonsmoking, pregnant women before 24 weeks' gestation with prospective follow-up to the child's age of 1 year. We measured 72-h personal household air pollution exposures, indexed by carbon monoxide (CO), four times prenatally and three times postnatally. Weekly fieldworker surveillance identified ill-appearing children for physician pneumonia assessment. We used quasi-Poisson models to examine associations between prenatal and postnatal CO and physician-diagnosed pneumonia and severe pneumonia. Sex-specific effects were examined.
RESULTS


Of the 1,306 live births, 1,141 infants were followed up with 55,605 child-weeks of fieldworker surveillance. The estimated risk for pneumonia and severe pneumonia in the first year of life increased by 10% (relative risk [RR], 1.10; 95% CI, 1.04-1.16) and 15% (RR, 1.15; 95% CI, 1.03-1.28), respectively, per 1-part per million (ppm) increase in average prenatal CO exposure and by 6% (RR, 1.06; 95% CI, 0.99-1.13) per 1-ppm increase in average postnatal CO exposure. Sex-stratified analyses suggest that in girls, higher prenatal CO exposure was associated with pneumonia risk, while no association was seen in boys.
INTERPRETATION


Prenatal household air pollution exposure increased risk of pneumonia and severe pneumonia in the first year of life. Clean-burning interventions may be most effective when begun prenatally.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT01335490; URL: www.clinicaltrials.gov.",2021,"The estimated risk for pneumonia and severe pneumonia in the first year of life increased by 10% (RR 1.10, 95% CI 1.04-1.16) and 15% (RR 1.15, 95% CI 1.03-1.28), respectively, per 1ppm increase in average prenatal CO exposure and by 6% (RR 1.06, 95% CI 0.99, 1.13) per 1ppm increase in average postnatal CO exposure.","['1,414 non-smoking, pregnant women prior to 24 weeks gestation with prospective follow-up to child age one', '1,306 live births', '1,141 infants were followed with 55,605 child-weeks of fieldworker surveillance']",['prenatal and postnatal household air pollution exposure'],"['72-hour personal household air pollution exposures, indexed by carbon monoxide (CO', 'average postnatal CO exposure', 'estimated risk for pneumonia and severe pneumonia', 'average prenatal CO exposure', 'Sex-specific effects']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",1414.0,0.093018,"The estimated risk for pneumonia and severe pneumonia in the first year of life increased by 10% (RR 1.10, 95% CI 1.04-1.16) and 15% (RR 1.15, 95% CI 1.03-1.28), respectively, per 1ppm increase in average prenatal CO exposure and by 6% (RR 1.06, 95% CI 0.99, 1.13) per 1ppm increase in average postnatal CO exposure.","[{'ForeName': 'Patrick L', 'Initials': 'PL', 'LastName': 'Kinney', 'Affiliation': 'Department of Environmental Health, Boston University School of Public Health, Boston, MA. Electronic address: pkinney@bu.edu.'}, {'ForeName': 'Kwaku-Poku', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, Brong Ahafo Region, Kintampo, Ghana.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Ae-Ngibise', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, Brong Ahafo Region, Kintampo, Ghana.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Burkart', 'Affiliation': 'Institute for Health Metrics and Evaluation, University of Washington, Seattle, WA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Boamah-Kaali', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, Brong Ahafo Region, Kintampo, Ghana.'}, {'ForeName': 'Mieks', 'Initials': 'M', 'LastName': 'Twumasi', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, Brong Ahafo Region, Kintampo, Ghana.'}, {'ForeName': 'Stephaney', 'Initials': 'S', 'LastName': 'Gyaase', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, Brong Ahafo Region, Kintampo, Ghana.'}, {'ForeName': 'Ashlinn', 'Initials': 'A', 'LastName': 'Quinn', 'Affiliation': 'Fogarty International Center, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Felix B', 'Initials': 'FB', 'LastName': 'Oppong', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, Brong Ahafo Region, Kintampo, Ghana.'}, {'ForeName': 'Blair J', 'Initials': 'BJ', 'LastName': 'Wylie', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Seyram', 'Initials': 'S', 'LastName': 'Kaali', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, Brong Ahafo Region, Kintampo, Ghana.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Chillrud', 'Affiliation': 'Lamont-Doherty Earth Observatory, Columbia University, Palisades, NY.'}, {'ForeName': 'Abena', 'Initials': 'A', 'LastName': 'Yawson', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, Brong Ahafo Region, Kintampo, Ghana.'}, {'ForeName': 'Darby W', 'Initials': 'DW', 'LastName': 'Jack', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health at Columbia University, New York, NY.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, Brong Ahafo Region, Kintampo, Ghana.'}]",Chest,['10.1016/j.chest.2021.06.080']
886,34297721,"Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.","INTRODUCTION


Plantar fasciitis is one of the common foot complaints that is chronic and can induce dysfunction. Total contact insole (TCI) is simple but effective in treating plantar fasciitis. Despite its effect, the cost and long duration for production have been the major flaws. Therefore, we developed a newly designed three-spike insole (TSI) that can be commercially productive and compared its clinical outcomes to TCI.
METHODS


Patients with plantar fasciitis refractory to conservative treatment for more than 6 weeks were candidates. We produced insoles with hardness of 58 ± 5 Shore-A. Twenty-eight patients were randomized with equal allocation to either TSI or TCI. The following assessment tools were used: visual analog scale (VAS), American Orthopaedic Foot and Ankle score, Foot and Ankle Outcome Score, Karlsson-Peterson (KP) score, Short Form-36 for quality of life, and Foot Function Index. Non-inferiority was declared if VAS was within the statistical variability of minimal important difference. A blinded assessor evaluated the groups at baseline and after 6, 12, and 24 weeks.
RESULTS


The groups were homogenous for majority of variables at baseline. Overall patient-reported satisfaction showed improvement from mean 5.2 (range, 1-12) weeks of wearing and all clinical outcome scores showed significant improvements in both groups over time on Friedman test (p ≤.032). TSI showed non-inferiority to TCI at each time point. Post hoc analysis revealed that many scales showed significant superiority of TSI at 3 month (p ≤.008) and KP score at 6 month (p < .001).
CONCLUSION


We reaffirmed that semi-rigid insole is effective in refractory plantar fasciitis and showed TSI restores pedal function more rapidly than TCI. TSI can be not only effective in deriving better clinical outcomes but also be manufactured for popularization to lower the price and producing time of orthosis.",2021,"Post hoc analysis revealed that many scales showed significant superiority of TSI at 3 month (p ≤.008) and KP score at 6 month (p < .001).
","['refractory plantar fasciitis', 'insoles with hardness of 58 ± 5 Shore-A. Twenty-eight patients', 'Patients with plantar fasciitis refractory to conservative treatment for more than 6 weeks were candidates']","['TSI or TCI', 'TSI', 'Total contact insole (TCI']","['visual analog scale (VAS), American Orthopaedic Foot and Ankle score, Foot and Ankle Outcome Score, Karlsson-Peterson (KP) score, Short Form-36 for quality of life, and Foot Function Index', 'KP score']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}]",28.0,0.12717,"Post hoc analysis revealed that many scales showed significant superiority of TSI at 3 month (p ≤.008) and KP score at 6 month (p < .001).
","[{'ForeName': 'Dong Woo', 'Initials': 'DW', 'LastName': 'Shim', 'Affiliation': ""Department of Orthopedic Surgery, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, South Korea.""}, {'ForeName': 'Seung-Yong', 'Initials': 'SY', 'LastName': 'Sung', 'Affiliation': ""Department of Orthopedic Surgery, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, South Korea.""}, {'ForeName': 'Whan-Yong', 'Initials': 'WY', 'LastName': 'Chung', 'Affiliation': ""Department of Orthopedic Surgery, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, South Korea.""}, {'ForeName': 'Kyung-Yil', 'Initials': 'KY', 'LastName': 'Kang', 'Affiliation': 'Department of Medicine, Catholic Kwandong Graduate School, Gangneungsi, Gangwondo, South Korea.'}, {'ForeName': 'Sung-Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'School of Mechanical, Automotive and Aeronautical Engineering Korea National University of Transportation, Chungju, Chungbuk, South Korea.'}, {'ForeName': 'Jin Woo', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong Sik', 'Initials': 'DS', 'LastName': 'Chae', 'Affiliation': ""Department of Orthopedic Surgery, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, South Korea.""}]",PloS one,['10.1371/journal.pone.0255064']
887,34302120,Extended follow-up of a short total diet replacement programme: results of the Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET) randomised controlled trial at 3 years.,"OBJECTIVES


To test the long-term effectiveness of a total diet replacement programme (TDR) for routine treatment of obesity in a primary care setting.
METHODS


This study was a pragmatic, two-arm, parallel-group, open-label, individually randomised controlled trial in adults with obesity. The outcomes were change in weight and biomarkers of diabetes and cardiovascular disease risk from baseline to 3 years, analysed as intention-to-treat with mixed effects models.
INTERVENTIONS


The intervention was TDR for 8 weeks, followed by food-reintroduction over 4 weeks. Behavioural support was provided weekly for 8 weeks, bi-weekly for the next 4 weeks, then monthly for 3 months after which no further support was provided. The usual care (UC) group received dietary advice and behavioural support from a practice nurse for up to 3 months.
RESULTS


Outcome measures were collected from 179 (66%) participants. Compared with baseline, at 3 years the TDR group lost -6.2 kg (SD 9.1) and usual care -2.7 kg (SD 7.7); adjusted mean difference -3.3 kg (95% CI: -5.2, -1.5), p < 0.0001. Regain from programme end (6 months) to 3 years was greater in TDR group +8.9 kg (SD 9.4) than UC + 1.2, (SD 9.1); adjusted mean difference +6.9 kg (95% CI 4.2, 9.5) P < 0.001. At 3 years TDR led to greater reductions than UC in diastolic blood pressure (mean difference -3.3 mmHg (95% CI:-6.2; -0.4) P = 0.024), and systolic blood pressure (mean differences -3.7 mmHg (95% CI: -7.4; 0.1) P = 0.057). There was no evidence of differences between groups in the change from baseline to 3 years HbA 1c  (-1.9 mmol/mol (95% CI: -0.7; 4.5; P = 0.15), LDL cholesterol concentrations (0.2 mmol/L (95% CI -0.3, 0.7) P = 0.39), cardiovascular risk score (QRISK2) (-0.37 (95% CI -0.96; 0.22); P = 0.22).
CONCLUSIONS


Treatment of people with obesity with a TDR programme compared with support from a practice nurse leads to greater weight loss which persists to at least 3 years, but there was only evidence of sustained improvements in BP and not in other aspects of cardiometabolic risk.",2021,"At 3 years TDR led to greater reductions than UC in diastolic blood pressure (mean difference -3.3 mmHg (95% CI:-6.2; -0.4) P = 0.024), and systolic blood pressure (mean differences -3.7 mmHg (95% CI: -7.4; 0.1) P = 0.057).","['adults with obesity', 'Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET) randomised controlled trial at 3 years', 'people with obesity with a TDR programme']","['total diet replacement programme (TDR', 'short total diet replacement programme', 'usual care (UC) group received dietary advice and behavioural support from a practice nurse for up to 3 months']","['weight loss', 'cardiovascular risk score (QRISK2', 'systolic blood pressure', 'diastolic blood pressure', 'LDL cholesterol concentrations', 'weight and biomarkers of diabetes and cardiovascular disease risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0420382', 'cui_str': 'Referral to doctor'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.363874,"At 3 years TDR led to greater reductions than UC in diastolic blood pressure (mean difference -3.3 mmHg (95% CI:-6.2; -0.4) P = 0.024), and systolic blood pressure (mean differences -3.7 mmHg (95% CI: -7.4; 0.1) P = 0.057).","[{'ForeName': 'Nerys M', 'Initials': 'NM', 'LastName': 'Astbury', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. nerys.astbury@phc.ox.ac.uk.'}, {'ForeName': 'Rhiannon M', 'Initials': 'RM', 'LastName': 'Edwards', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fitsum', 'Initials': 'F', 'LastName': 'Ghebretinsea', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Milensu', 'Initials': 'M', 'LastName': 'Shanyinde', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Mollison', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",International journal of obesity (2005),['10.1038/s41366-021-00915-1']
888,34304264,The nurse-coordinated cardiac care bridge transitional care programme: a randomised clinical trial.,"BACKGROUND


after hospitalisation for cardiac disease, older patients are at high risk of readmission and death.
OBJECTIVE


the cardiac care bridge (CCB) transitional care programme evaluated the impact of combining case management, disease management and home-based cardiac rehabilitation (CR) on hospital readmission and mortality.
DESIGN


single-blind, randomised clinical trial.
SETTING


the trial was conducted in six hospitals in the Netherlands between June 2017 and March 2020. Community-based nurses and physical therapists continued care post-discharge.
SUBJECTS


cardiac patients ≥ 70 years were eligible if they were at high risk of functional loss or if they had had an unplanned hospital admission in the previous 6 months.
METHODS


the intervention group received a comprehensive geriatric assessment-based integrated care plan, a face-to-face handover with the community nurse before discharge and follow-up home visits. The community nurse collaborated with a pharmacist and participants received home-based CR from a physical therapist. The primary composite outcome was first all-cause unplanned readmission or mortality at 6 months.
RESULTS


in total, 306 participants were included. Mean age was 82.4 (standard deviation 6.3), 58% had heart failure and 92% were acutely hospitalised. 67% of the intervention key-elements were delivered. The composite outcome incidence was 54.2% (83/153) in the intervention group and 47.7% (73/153) in the control group (risk differences 6.5% [95% confidence intervals, CI -4.7 to 18%], risk ratios 1.14 [95% CI 0.91-1.42], P = 0.253). The study was discontinued prematurely due to implementation activities in usual care.
CONCLUSION


in high-risk older cardiac patients, the CCB programme did not reduce hospital readmission or mortality within 6 months.
TRIAL REGISTRATION


Netherlands Trial Register 6,316, https://www.trialregister.nl/trial/6169.",2021,"The composite outcome incidence was 54.2% (83/153) in the intervention group and 47.7% (73/153) in the control group (risk differences 6.5% [95% confidence intervals, CI -4.7 to 18%], risk ratios 1.14 [95% CI 0.91-1.42], P = 0.253).","['cardiac patients\u2009≥\u200970\xa0years were eligible if they were at high risk of functional loss or if they had had an unplanned hospital admission in the previous 6\xa0months', 'Mean age was 82.4 (standard deviation 6.3), 58% had heart failure and 92% were acutely hospitalised', 'high-risk older cardiac patients', 'in total, 306 participants were included', 'six hospitals in the Netherlands between June 2017 and March 2020']","['home-based CR from a physical therapist', 'nurse-coordinated cardiac care bridge transitional care programme', 'disease management and home-based cardiac rehabilitation (CR', 'comprehensive geriatric assessment-based integrated care plan, a face-to-face handover with the community nurse before discharge and follow-up home visits']","['hospital readmission and mortality', 'hospital readmission or mortality', 'cause unplanned readmission or mortality at 6\xa0months']","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0557521', 'cui_str': 'Community nurse'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",306.0,0.141252,"The composite outcome incidence was 54.2% (83/153) in the intervention group and 47.7% (73/153) in the control group (risk differences 6.5% [95% confidence intervals, CI -4.7 to 18%], risk ratios 1.14 [95% CI 0.91-1.42], P = 0.253).","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Jepma', 'Affiliation': 'Amsterdam UMC, Department of Cardiology, Amsterdam, the Netherlands.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Verweij', 'Affiliation': 'Amsterdam UMC, Department of Cardiology, Amsterdam, the Netherlands.'}, {'ForeName': 'Bianca M', 'Initials': 'BM', 'LastName': 'Buurman', 'Affiliation': 'Amsterdam University of Applied Sciences, Faculty of Health, Centre of Expertise Urban Vitality, Amsterdam University of Applied Sciences,Amsterdam, the Netherlands.'}, {'ForeName': 'Michel S', 'Initials': 'MS', 'LastName': 'Terbraak', 'Affiliation': 'Amsterdam University of Applied Sciences, Faculty of Health, Centre of Expertise Urban Vitality, Amsterdam University of Applied Sciences,Amsterdam, the Netherlands.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Daliri', 'Affiliation': 'OLVG Hospital, Department of Clinical Pharmacy, Amsterdam, the Netherlands.'}, {'ForeName': 'Corine H M', 'Initials': 'CHM', 'LastName': 'Latour', 'Affiliation': 'Amsterdam University of Applied Sciences, Faculty of Health, Centre of Expertise Urban Vitality, Amsterdam University of Applied Sciences,Amsterdam, the Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Ter Riet', 'Affiliation': 'Amsterdam UMC, Department of Cardiology, Amsterdam, the Netherlands.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Karapinar-Çarkit', 'Affiliation': 'OLVG Hospital, Department of Clinical Pharmacy, Amsterdam, the Netherlands.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Bovenij Medical Centre, Department of Cardiology, Amsterdam, the Netherlands.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Klunder', 'Affiliation': 'OLVG Hospital, Department of Cardiology, Amsterdam, the Netherlands.'}, {'ForeName': 'Su-San', 'Initials': 'SS', 'LastName': 'Liem', 'Affiliation': 'Amstelland Hospital, Department of Cardiology, Amstelveen, the Netherlands.'}, {'ForeName': 'Arno H M', 'Initials': 'AHM', 'LastName': 'Moons', 'Affiliation': 'OLVG Hospital, Department of Cardiology, Amsterdam, the Netherlands.'}, {'ForeName': 'Ron J G', 'Initials': 'RJG', 'LastName': 'Peters', 'Affiliation': 'Amsterdam UMC, Department of Cardiology, Amsterdam, the Netherlands.'}, {'ForeName': 'Wilma J M', 'Initials': 'WJM', 'LastName': 'Scholte Op Reimer', 'Affiliation': 'Amsterdam UMC, Department of Cardiology, Amsterdam, the Netherlands.'}]",Age and ageing,['10.1093/ageing/afab146']
889,34309111,Association Between Caregiver-Oncologist Discordance in Patient's Life Expectancy Estimates and Caregiver Perceived Autonomy Support by the Oncologist.,"BACKGROUND


Caregiver perceived autonomy support by the oncologist is important for caregiver well-being and may be affected by the patient's survival. We determined the association of caregiver-oncologist discordance in patient's life expectancy estimates with perceived autonomy support over time and whether the association differed by patient survival status.
MATERIALS AND METHODS


We used data from a geriatric assessment cluster-randomized trial (URCC 13070) that recruited patients aged at least 70 years with incurable cancer considering or receiving treatment, their caregivers, and their oncologists. At baseline, caregivers and oncologists were asked to estimate patient's life expectancy (0-6 months, 7-12 months, 1-2 years, 2-5 years, and >5 years; any difference in response was considered discordant). At 4-6 weeks, 3 months, and 6 months, caregivers completed the Health Care Climate Questionnaire (HCCQ), which measured perceived autonomy support by the oncologist. Generalized estimating equation modeling was conducted to assess the association of baseline caregiver-oncologist discordance with longitudinal HCCQ scores, stratified by patient 6-month survival status.
RESULTS


Discordant life expectancy estimates were present in 72.0% of dyads. In multivariate analyses, caregiver-oncologist discordance in patient's life expectancy estimates was associated with higher caregiver HCCQ scores. In stratified analysis, caregiver-oncologist discordance was associated with lower caregiver HCCQ scores (β = -3.46; 95% CI, -4.64 to -2.29) among patients who died within 6 months but with higher caregiver HCCQ scores (β = 1.33; 95% CI, 0.63-2.04) among patients who survived beyond 6 months.
CONCLUSION


Interventions aimed at mitigating discordance need to consider its association with caregiver perceived autonomy support and patient's survival in order to better inform caregiver expectations.
IMPLICATIONS FOR PRACTICE


Among patients who died within the first 6 months, caregivers who estimated a different length of life for the patient compared with oncologists were more likely to report lower support from the oncologist, whereas the opposite relationship was seen within patients who survived beyond the first 6 months. When designing interventions to improve caregiver understanding of the patient's prognosis, its relationship with caregiver-perceived support and patient's survival needs to be considered.",2021,"In multivariate analyses, caregiver-oncologist discordance in patient's life expectancy estimates was associated with higher HCCQ scores.","['patients aged ≥70 with incurable cancer considering or receiving treatment, their caregivers, and oncologists']",[],"['caregiver HCCQ scores', 'length of life', ""patient's life expectancy"", 'Health Care Climate Questionnaire (HCCQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",,0.274972,"In multivariate analyses, caregiver-oncologist discordance in patient's life expectancy estimates was associated with higher HCCQ scores.","[{'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Tuch', 'Affiliation': 'Department of Aged Care, Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Chandrika', 'Initials': 'C', 'LastName': 'Sanapala', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, Piscataway, New Jersey, USA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Soto-Perez-de-Celis', 'Affiliation': 'Department of Geriatrics, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Surgery, Cancer Control, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'Department of Surgery, Cancer Control, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Flannery', 'Affiliation': 'School of Nursing, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Yousefi-Nooraie', 'Affiliation': 'Department of Public Health Sciences, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Aarne', 'Affiliation': 'SCOREboard Advisory Group, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Geer', 'Affiliation': 'Metro Minnesota Community Oncology Research Program, St. Louis Park, Minnesota, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': ""O'Rourke"", 'Affiliation': 'National Cancer Institute Community Oncology Research Program (NCORP) of the Carolinas (Greenville Health System NCORP), Greenville, South Carolina, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Nevada Cancer Research Foundation NCORP, Las Vegas, Nevada, USA.'}, {'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York, USA.'}]",The oncologist,['10.1002/onco.13913']
890,34311957,Improved Implant Positioning of Cephalomedullary Nail for Trochanteric Fractures Using the Stryker ADAPT Navigation System.,"BACKGROUND


Tip-apex distance (TAD) of greater than 25 mm increases the risk of cephalomedullary nail (CMN) cutout for trochanteric hip fractures. The Stryker ADAPT navigation system provides intraoperative feedback to guide implant positioning. This study compares lag screw positioning using the ADAPT to conventional methods and investigates if the use of ADAPT impacts operating room efficiency.
METHODS


Retrospective review of 82 consecutive patients who underwent Stryker Gamma3 CMN for a peritrochanteric hip fracture. Study groups were assigned based on use of ADAPT navigation. Primary outcome was TAD. Secondary outcomes were lag screw position, operative time, and radiation dose. Univariate analysis of covariance was used to compare primary outcome measures, controlling for fracture classification.
RESULTS


41 patients were assigned to each group. When comparing ADAPT and conventional groups mean TAD was 14.45±3.68 and 16.41±3.78 mm (p = 0.023). A higher portion of ADAPT nails (85.4% vs 63.4%, p = 0.024) were center- center within the femoral head compared to conventional methods. There were no significant differences with regards to operative time, fluoroscopy time, or radiation dose.
CONCLUSION


ADAPT navigation provides intraoperative feedback to achieve improved lag screw positioning, leading to improved TAD. The overall improvement in TAD does not likely reach clinical significance. The system requires minimal setup in the operating room, does not impact workflow, and the user interface is straight forward.",2021,"A higher portion of ADAPT nails (85.4% vs 63.4%, p = 0.024) were center- center within the femoral head compared to conventional methods.","['Trochanteric Fractures', 'for a peritrochanteric hip fracture', '41 patients', '82 consecutive patients who underwent']","['Stryker Gamma3 CMN', 'Cephalomedullary Nail']","['ADAPT nails', 'operative time, fluoroscopy time', 'risk of cephalomedullary nail (CMN', 'lag screw position, operative time, and radiation dose', 'lag screw positioning, leading to improved TAD']","[{'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0027342', 'cui_str': 'Nail plate structure'}]","[{'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",41.0,0.162038,"A higher portion of ADAPT nails (85.4% vs 63.4%, p = 0.024) were center- center within the femoral head compared to conventional methods.","[{'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Simcox', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone - Long Island Hospital, NYU Langone Health, Mineola, New York, USA. Electronic address: Trevor.Simcox@nyulangone.org.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tarazona', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone - Long Island Hospital, NYU Langone Health, Mineola, New York, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Becker', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone - Long Island Hospital, NYU Langone Health, Mineola, New York, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Ayres', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone - Long Island Hospital, NYU Langone Health, Mineola, New York, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gould', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone - Long Island Hospital, NYU Langone Health, Mineola, New York, USA.'}]",Injury,['10.1016/j.injury.2021.07.021']
891,34310714,Mutational profiles of metastatic colorectal cancer treated with FOLFIRI plus cetuximab or bevacizumab before and after secondary resection (AIO KRK 0306; FIRE-3).,"Secondary resection of metastases is recommended in metastatic colorectal cancer (mCRC). Data describing changes in mutational profiles of corresponding primary tumor and metastatic tissue after conversion treatment are limited. Next generation sequencing was performed in formalin-fixed mCRC samples from patients of the FIRE-3 trial (FOLFIRI plus cetuximab or bevacizumab) before treatment start (baseline) and after secondary resection of metastases (post baseline). Changes of mutational profiles and tumor mutational burden (TMB) were assessed within a post-hoc analysis. Median overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) were compared between treatment arms. Paired tumor samples were obtained from 25 patients (19 RAS wild-type, 6 RAS mutant by pyrosequencing). ORR (92.0% vs 58.0%) and OS (60.8 vs 35.4 months, hazard ratio = 0.39 [95% CI 0.14-1.12], P = .08) were higher for patients receiving cetuximab. After conversion therapy, 56 alterations (42 in the cetuximab and 14 in the bevacizumab arm) were newly observed in 18 patients (9 each treated with cetuximab or bevacizumab). Gains (n = 21) and losses (n = 21) of alterations occurred during cetuximab-based treatment, while mainly gains of alterations occurred during bevacizumab (n = 10). Three of nine patients treated with cetuximab that presented a change of mutational profiles, developed resistance to cetuximab. Mutational profiles were largely comparable before and after treatment with anti-VEGF or anti-EGFR directed monoclonal antibodies after secondary resection. Mutations associated with resistance to anti-EGFR antibodies were observed in only one-third of patients.",2021,Mutational profiles were largely comparable before and after treatment with anti-VEGF or anti-EGFR directed monoclonal antibodies after secondary resection.,"['metastatic colorectal cancer', 'metastatic colorectal cancer (mCRC']","['cetuximab', 'FOLFIRI plus cetuximab or bevacizumab', 'bevacizumab', 'cetuximab or bevacizumab']","['Changes of mutational profiles and tumor mutational burden (TMB', 'OS', 'Median overall survival (OS), progression-free survival (PFS) and objective response rate (ORR', 'resistance to anti-EGFR antibodies', 'ORR']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.0619775,Mutational profiles were largely comparable before and after treatment with anti-VEGF or anti-EGFR directed monoclonal antibodies after secondary resection.,"[{'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Stahler', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Medical Department, Division of Hematology, Oncology and Tumor Immunology, Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, University of Munich, Munich, Germany.'}, {'ForeName': 'Julian Walter', 'Initials': 'JW', 'LastName': 'Holch', 'Affiliation': 'Department of Medicine III, University Hospital, University of Munich, Munich, Germany.'}, {'ForeName': 'Jobst Christian', 'Initials': 'JC', 'LastName': 'von Einem', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Medical Department, Division of Hematology, Oncology and Tumor Immunology, Berlin, Germany.'}, {'ForeName': 'Christoph Benedikt', 'Initials': 'CB', 'LastName': 'Westphalen', 'Affiliation': 'Department of Medicine III, University Hospital, University of Munich, Munich, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Heinrich', 'Affiliation': 'Department of Medicine III, University Hospital, University of Munich, Munich, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schlieker', 'Affiliation': 'STABURO Statistical Consulting GmbH, Munich, Germany.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Jelas', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Medical Department, Division of Hematology, Oncology and Tumor Immunology, Berlin, Germany.'}, {'ForeName': 'Annabel Helga Sophie', 'Initials': 'AHS', 'LastName': 'Alig', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Medical Department, Division of Hematology, Oncology and Tumor Immunology, Berlin, Germany.'}, {'ForeName': 'Laura Elisabeth', 'Initials': 'LE', 'LastName': 'Fischer', 'Affiliation': 'Department of Medicine III, University Hospital, University of Munich, Munich, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Weiss', 'Affiliation': 'Department of Medicine III, University Hospital, University of Munich, Munich, Germany.'}, {'ForeName': 'Dominik Paul', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Medical Department, Division of Hematology, Oncology and Tumor Immunology, Berlin, Germany.'}, {'ForeName': 'Ludwig Fischer', 'Initials': 'LF', 'LastName': 'von Weikersthal', 'Affiliation': 'Klinikum St. Marien Amberg, Amberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Onkologische Praxis, Ravensburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kiani', 'Affiliation': 'Department of Medicine IV, Klinikum Bayreuth GmbH, Bayreuth, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Department of Internal Medicine I, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'VK&K Studien GbR, Landshut, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kirchner', 'Affiliation': 'LMU Munich, German Cancer Consortium (DKTK), partner site Munich, German Cancer Research Centre (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'LMU Munich, German Cancer Consortium (DKTK), partner site Munich, German Cancer Research Centre (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Medical Department, Division of Hematology, Oncology and Tumor Immunology, Berlin, Germany.'}]",International journal of cancer,['10.1002/ijc.33747']
892,34310692,A blinded randomized study comparing intubating conditions after either rocuronium 0.6 mg·kg -1  or remifentanil 2 µg·kg -1  in elderly patients.,"BACKGROUND


To facilitate tracheal intubation, either a neuromuscular blocking agent or a bolus dose of remifentanil can be administered. We hypothesized that rocuronium 0.6 mg·kg -1  provided a larger proportion of excellent intubating conditions compared to remifentanil 2 µg·kg -1  in patients above 80 years.
METHODS


A total of 78 patients were randomized to either rocuronium 0.6 mg·kg -1  or remifentanil 2 µg·kg -1  . General anaesthesia was initiated with fentanyl and propofol. Two minutes after the administration of either rocuronium or remifentanil, tracheal intubating conditions were evaluated using the Fuchs-Buder scale by a blinded investigator, and our primary outcome was the proportion of patients presenting intubating conditions deemed as excellent. Further outcomes included the Intubating Difficulty Scale (IDS), hoarseness or sore throat 24 h postoperatively, and intervention against hypotension.
RESULTS


No difference in the occurrence of excellent intubating conditions was found comparing the rocuronium group with the remifentanil group; 10 (28%) versus 15 (39%) (p = .29), respectively, relative risk = 0.72. Interventions against hypotension were used in 24 (67%) versus 28 (74%) (p = .51), respectively. Hoarseness and sore throat 24 h postoperatively were found in 37% versus 35% p = .86, and 14% versus 5% p = .20, respectively. The IDS score was 2 versus 2 p = .48.
CONCLUSION


No difference in intubating conditions was found 2 min after the administration of either rocuronium 0.6 mg·kg -1  or remifentanil 2 µg·kg -1  in patients aged above 80 years. Intubation conditions were less than optimal in a large proportion of this patient population.
CLINICAL TRIALS REGISTRATION


NCT04287426.",2021,"Hoarseness and sore throat 24 hours postoperatively were found in 37% vs 35% P=0.86, and 14% vs 5% P=0.20, respectively.","['78 patients', 'elderly patients']","['rocuronium', 'rocuronium 0.6 mg kg -1  or remifentanil', 'fentanyl and propofol', 'rocuronium or remifentanil', 'remifentanil']","['IDS score', 'occurrence of excellent intubating conditions', 'intubating conditions', 'larger proportion of excellent intubating conditions', 'Hoarseness and sore throat 24 hours postoperatively', 'Intubating Difficulty Scale (IDS), hoarseness or sore throat 24 hours postoperatively, and intervention against hypotension', 'Interventions against hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",78.0,0.659855,"Hoarseness and sore throat 24 hours postoperatively were found in 37% vs 35% P=0.86, and 14% vs 5% P=0.20, respectively.","[{'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Vested', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Sørensen', 'Affiliation': 'Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Bjerring', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus E', 'Initials': 'RE', 'LastName': 'Christensen', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Dinesen', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Malene', 'Initials': 'M', 'LastName': 'Vang', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Gilvanoff', 'Affiliation': 'Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thea Ellehammer', 'Initials': 'TE', 'LastName': 'Hansen', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13957']
893,34314449,An evaluation of factors that may influence clinicians' decisions not to enroll eligible patients into randomized trials in critical care.,"OBJECTIVES


To determine the association between intensive care unit (ICU) characteristics and clinicians' decision to decline eligible patients for randomization into a multicentered pragmatic comparative-effectiveness controlled trial.
METHODS


Screening logs from the Adjunctive Glucocorticoid Therapy in Septic Shock Trial (ADRENAL) and site-level data from the College of Intensive Care Medicine and Australia New Zealand Intensive Care Society were examined. The effects of ICU characteristics such as tertiary academic status, research coordinator availability, number of admissions, and ICU affiliations on clinicians declining to randomize eligible patients were calculated using mixed effects logistic regression modelling.
RESULTS


There were 21,818 patients screened for inclusion in the ADRENAL trial at 69 sites across five countries, out of which 5,501 were eligible, 3,800 were randomized and 659 eligible patients were declined for randomization by the treating clinician. The proportion of eligible patients declined by clinicians at individual ICUs ranged from 0 to41%. In the multivariable model, none of the ICU characteristics were significantly associated with higher clinician decline rate.
CONCLUSIONS


Neither tertiary academic status, nor other site-level variables were significantly associated with increased rate of clinicians declining eligible patients.",2021,"Neither tertiary academic status, nor other site-level variables were significantly associated with increased rate of clinicians declining eligible patients.","['21,818 patients screened for inclusion in the ADRENAL trial at 69 sites across five countries, out of which 5,501 were eligible, 3,800 were randomized and 659 eligible patients were declined for randomization by the treating clinician', 'Screening logs from the Adjunctive Glucocorticoid Therapy in Septic Shock Trial (ADRENAL) and site-level data from the College of Intensive Care Medicine and Australia New Zealand Intensive Care Society']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",[],[],,0.045283,"Neither tertiary academic status, nor other site-level variables were significantly associated with increased rate of clinicians declining eligible patients.","[{'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Ramanan', 'Affiliation': 'Intensive Care Unit, Caboolture Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dorrilyn', 'Initials': 'D', 'LastName': 'Rajbhandari', 'Affiliation': 'Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Myburgh', 'Affiliation': 'Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}]",PloS one,['10.1371/journal.pone.0255361']
894,34319487,Ultrasound-guided internal jugular venipuncture using pocket-sized versus standard ultrasound devices: a prospective non-inferiority trial.,"PURPOSE


Pocket-sized ultrasound devices (PUDs) are commonly adopted for bedside use despite their inferior performance compared with standard ultrasound devices (SUDs). We investigated the non-inferiority of PUDs versus SUDs for ultrasound-guided internal jugular venipuncture.
METHODS


All patients undergoing scheduled surgery with general anesthesia and internal jugular vein catheter placement were prospectively included in this randomized non-inferiority trial to compare the qualities of the internal jugular venipuncture between the PUD group (Group P) and SUD group (Group S). The primary endpoint was puncture time, and the secondary endpoints included number of punctures, needle and guidewire visibility, and anatomic visibility.
RESULTS


Fifty-two patients were randomized to one of the two groups (26 per group). The mean (SEM) puncture time was 56.4 (10.9) s in Group P and 45.5 (4.0) s in Group S. The mean difference of 10.9 s was within the prespecified non-inferiority margin of 100% (two-sided 95% CI: - 12.9-34.6, upper limit of the 95% CI: 45.5) for puncture time. The mean (SEM) number of punctures was 1.15 (0.12) times in Group P and 1.12 (0.06) times in Group S. The difference of 0.04 punctures was within the prespecified non-inferiority margin of 100% (two-sided 95% CI: - 0.24-0.31, upper limit of the 95% CI: 1.12) for number of punctures. Non-inferiority was not shown for needle and guidewire visibility and anatomic visibility.
CONCLUSION


PUDs for internal jugular venipuncture are not inferior to SUDs with regard to puncture time and number of punctures, despite differences in visibility and device performance.",2021,"CONCLUSION


PUDs for internal jugular venipuncture are not inferior to SUDs with regard to puncture time and number of punctures, despite differences in visibility and device performance.","['All patients undergoing scheduled surgery with', 'Fifty-two patients']","['general anesthesia and internal jugular vein catheter placement', 'Ultrasound-guided internal jugular venipuncture using pocket-sized versus standard ultrasound devices']","['mean (SEM) puncture time', 'number of punctures, needle and guidewire visibility, and anatomic visibility', 'puncture time', 'visibility and device performance', 'mean (SEM) number of punctures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319570', 'cui_str': '52'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",52.0,0.169048,"CONCLUSION


PUDs for internal jugular venipuncture are not inferior to SUDs with regard to puncture time and number of punctures, despite differences in visibility and device performance.","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Anesthesia, Nayoro City General Hospital, Nishi 7 Minami 8-1, Nayoro, Hokkaido, 096-8511, Japan. cab55640@yahoo.co.jp.'}, {'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Inagaki', 'Affiliation': 'Department of Emergency Medicine, Nayoro City General Hospital, Nayoro, Hokkaido, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Iwata', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Asahikawa, Hokkaido, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tada', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Asahikawa, Hokkaido, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Tateoka', 'Affiliation': 'Department of Anesthesia, Nayoro City General Hospital, Nishi 7 Minami 8-1, Nayoro, Hokkaido, 096-8511, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Sasakawa', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Asahikawa, Hokkaido, Japan.'}]",Journal of medical ultrasonics (2001),['10.1007/s10396-021-01118-x']
895,34258686,The MOBILISE study: utilisation of ambulatory pumps in the inpatient setting to administer continuous antibiotic infusions-a randomised controlled trial.,"In the inpatient setting, antibiotics are generally administered via bedside pumps with multiple daily dosing. Utilisation of a continuous antibiotic infusion (CAI) instead might have patient and nursing satisfaction, workflow efficiencies and infection control benefits. We aimed to study the utilisation of CAI in the inpatient setting for routine antibiotic administration. Patients receiving a peripherally inserted central venous catheter (PICC) for antibiotic administration were screened for the study. The patients were randomised to either (1) standard pump and intermittent antibiotic administration (IAA) or (2) CAI via an ambulatory pump. An accelerometer placed on the ankle was used to assess patient activity. Nursing and patient satisfaction surveys were also carried out. Forty patients met the study criteria for enrolment with 21 patients being enrolled in the CAI arm of the study. One hundred and five days of accelerometer recordings were available for analysis. The geometric mean activity was 45 min/day in the standard arm and 64 min/day in the CAI arm. This represented a 42% (95% CI: -14 to 133%, p = 0.16) difference in activity between the two groups. Nursing staff reported that they spent less time throughout their shift attending the antibiotic line or pump in patients who were in the CAI arm of the study (p < 0.001). In addition, patients in this arm of the study were more likely to recommend this method of administration of antibiotics to a family member (p =0.0001). The MOBILISE study showed nursing and patient satisfaction when CAI were utilised in the inpatient setting. A statistically non-significant difference in mobility was seen. The trial was registered (28/03/2018) with the Australia New Zealand Clinical Trials Registry (ACTRN12618000452291).",2021,"Utilisation of a continuous antibiotic infusion (CAI) instead might have patient and nursing satisfaction, workflow efficiencies and infection control benefits.","['Patients receiving a peripherally inserted central venous catheter (PICC) for antibiotic administration were screened for the study', 'Forty patients met the study criteria for enrolment with 21 patients being enrolled in the CAI arm of the study']","['standard pump and intermittent antibiotic administration (IAA) or (2) CAI via an ambulatory pump', 'ambulatory pumps', 'continuous antibiotic infusion (CAI']","['geometric mean activity', 'activity', 'mobility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",40.0,0.1417,"Utilisation of a continuous antibiotic infusion (CAI) instead might have patient and nursing satisfaction, workflow efficiencies and infection control benefits.","[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'McCarthy', 'Affiliation': ""Infectious Diseases Department, Level 6 Joyce Tweddell Building, Royal Brisbane and Women's Hospital, Cnr Butterfield St and Herston Road, Brisbane, QLD, 4029, Australia. Kate.mccarthy@uq.edu.au.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Harris-Brown', 'Affiliation': 'University of Queensland Centre for Clinical Research, Brisbane, QLD, Australia.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Smits', 'Affiliation': 'RECOVER Injury Research Centre, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Legg', 'Affiliation': ""Infectious Diseases Department, Level 6 Joyce Tweddell Building, Royal Brisbane and Women's Hospital, Cnr Butterfield St and Herston Road, Brisbane, QLD, 4029, Australia.""}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'University of Queensland Centre for Clinical Research, Brisbane, QLD, Australia.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Paterson', 'Affiliation': ""Infectious Diseases Department, Level 6 Joyce Tweddell Building, Royal Brisbane and Women's Hospital, Cnr Butterfield St and Herston Road, Brisbane, QLD, 4029, Australia.""}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-021-04294-3']
896,34260650,"Effects of water stably-enriched with oxygen as a novel method of tissue oxygenation on mitochondrial function, and as adjuvant therapy for type 2 diabetes in a randomized placebo-controlled trial.","BACKGROUND


Diabetes mellitus is associated with inadequate delivery of oxygen to tissues. Cellular hypoxia is associated with mitochondrial dysfunction which increases oxidative stress and hyperglycaemia. Hyperbaric oxygenation therapy, which was shown to improve insulin sensitivity, is impractical for regular use. We evaluated the effects of water which is stably-enriched with oxygen (ELO water) to increase arterial blood oxygen levels, on mitochondrial function in the presence of normal- or high-glucose environments, and as glucose-lowering therapy in humans.
METHODS


We compared arterial blood oxygen levels in Sprague-Dawley rats after 7 days of ad libitum ELO or tap water consumption. Mitochondrial stress testing, and flow cytometry analysis of mitochondrial mass and membrane potential, were performed on human HepG2 cells cultured in four Dulbecco's Modified Eagle Medium media, made with ELO water or regular (control) water, at normal (5.5 mM) or high (25 mM) glucose concentrations. We also randomized 150 adults with type 2 diabetes (mean age 53 years, glycated haemoglobin HbA1c 8.9% [74 mmol/mol], average duration of diabetes 12 years) to drink 1.5 litres daily of bottled ELO water or drinking water.
RESULTS


ELO water raised arterial oxygen tension pO2 significantly (335 ± 26 vs. 188 ± 18 mmHg, p = 0.006) compared with tap water. In cells cultured in control water, mitochondrial mass and membrane potential were both significantly lower at 25 mM glucose compared with 5.5 mM glucose; in contrast, mitochondrial mass and membrane potential did not differ significantly at normal or high glucose concentrations in cells cultured in ELO water. The high-glucose environment induced a greater mitochondrial proton leak in cells cultured in ELO water compared to cells cultured in control medium at similar glucose concentration. In type 2 diabetic adults, HbA1c decreased significantly (p = 0.002) by 0.3 ± 0.7% (4 ± 8 mmol/mol), with ELO water after 12 weeks of treatment but was unchanged with placebo.
CONCLUSIONS


ELO water raises arterial blood oxygen levels, appears to have a protective effect on hyperglycaemia-induced reduction in mitochondrial mass and mitochondrial dysfunction, and may be effective adjuvant therapy for type 2 diabetes.",2021,"RESULTS


ELO water raised arterial oxygen tension pO2 significantly (335 ± 26 vs. 188 ± 18 mmHg, p = 0.006) compared with tap water.","['humans', '150 adults with type 2 diabetes (mean age 53 years, glycated haemoglobin HbA1c 8.9% [74 mmol/mol], average duration of diabetes 12 years) to drink 1.5 litres daily of bottled ELO water or drinking water']","['water stably-enriched with oxygen', 'water which is stably-enriched with oxygen (ELO water', 'ELO', 'Hyperbaric oxygenation therapy', 'placebo']","['arterial blood oxygen levels', 'ELO water raised arterial oxygen tension pO2', 'oxidative stress and hyperglycaemia', 'mitochondrial mass and membrane potential', 'insulin sensitivity']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0025251', 'cui_str': 'Transmembrane Potentials'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",150.0,0.0432823,"RESULTS


ELO water raised arterial oxygen tension pO2 significantly (335 ± 26 vs. 188 ± 18 mmHg, p = 0.006) compared with tap water.","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Khoo', 'Affiliation': 'Department of Medicine, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Christoph E', 'Initials': 'CE', 'LastName': 'Hagemeyer', 'Affiliation': 'NanoBiotechnology Laboratory, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Darren C', 'Initials': 'DC', 'LastName': 'Henstridge', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sumukh', 'Initials': 'S', 'LastName': 'Kumble', 'Affiliation': 'NanoBiotechnology Laboratory, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ting-Yi', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'NanoBiotechnology Laboratory, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'NanoBiotechnology Laboratory, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Linsey', 'Initials': 'L', 'LastName': 'Gani', 'Affiliation': 'Department of Medicine, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'King', 'Affiliation': 'Department of Medicine, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Shui-Boon', 'Initials': 'SB', 'LastName': 'Soh', 'Affiliation': 'Department of Medicine, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Puar', 'Affiliation': 'Department of Medicine, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Au', 'Affiliation': 'Department of Medicine, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Eberta', 'Initials': 'E', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Tunn-Lin', 'Initials': 'TL', 'LastName': 'Tay', 'Affiliation': 'Department of Medicine, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Kam', 'Affiliation': 'Clinical Trials and Research Unit, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Eng-Kiong', 'Initials': 'EK', 'LastName': 'Teo', 'Affiliation': 'Department of Medicine, Changi General Hospital, Singapore, Singapore.'}]",PloS one,['10.1371/journal.pone.0254619']
897,34260606,Breaking up classroom sitting time with cognitively engaging physical activity: Behavioural and brain responses.,"INTRODUCTION


Classroom-based active breaks are a feasible and effective way to reduce and break up sitting time, and to potentially benefit physical health in school children. However, the effect of active breaks on children's cognitive functions and brain activity remains unclear.
OBJECTIVE


We investigated the impact of an active break intervention on typically developing children's cognitive functions and brain activity, sitting/standing/stepping, on-task behaviour, and enjoyment.
METHODS


Up to 141 children, aged between 6 and 8 years (46% girls), were included, although about half of them completed two of the assessments (n = 77, working memory; n = 67, dorsolateral prefrontal cortex haemodynamic response). Classrooms from two consenting schools were randomly allocated to a six-week simple or cognitively engaging active break intervention. Classrooms from another school acted as a control group. The main analyses used linear mixed models, clustered at the class level and adjusted for sex and age, to investigate the effects of the interventions on response inhibition, lapses of attention, working memory, event-related brain haemodynamic response (dorsolateral prefrontal cortex). The mediating effects of sitting/standing/stepping on cognition/brain activity were also explored. To test intervention fidelity, we investigated differences by group on the change values in children's sitting, standing, and moving patterns during class/school time using linear mixed models. Generalized linear mixed models clustered at the individual level were used to examine on-task behaviour data. For the intervention groups only, we also assessed children's perceived enjoyment, physical exertion and mental exertion related to the active breaks and compared the results using independent t-tests.
RESULTS


There was a significantly greater positive change in the proportion of deoxygenated haemoglobin in the left dorsolateral prefrontal cortex of children assigned to cognitively engaging active breaks compared to the control group (B = 1.53 × 10-07, 95% CI [0.17 × 10-07, 2.90 × 10-07]), which under the same cognitive performance is suggestive of improved neural efficiency. Mixed models showed no significant effects on response inhibition, lapses of attention, working memory. The mediation analysis revealed that the active breaks positively affected response inhibition via a change in sitting and standing time. The sitting, standing, and moving patterns and on-task behaviour were positively affected by the active breaks at end of trial, but not at mid-trial. Children in both intervention groups showed similarly high levels of enjoyment of active breaks.
CONCLUSION


Cognitively engaging active breaks may improve brain efficiency in the dorsolateral prefrontal cortex, the neural substrate of executive functions, as well as response inhibition, via effects partially mediated by the change in sitting/stepping time. Active breaks can effectively reduce sitting and increase standing/stepping and improve on-task behaviour, but the regular implementation of these activities might require time for teachers to become familiar with. Further research is needed to confirm what type of active break best facilitates cognition.",2021,There was a significantly greater positive change in the proportion of deoxygenated haemoglobin in the left dorsolateral prefrontal cortex of children assigned to cognitively engaging active breaks compared to the control group (B =,"['school children', 'Classrooms from two consenting schools', 'Up to 141 children, aged between 6 and 8 years (46% girls), were included, although about half of them completed two of the assessments (n = 77, working memory; n = 67, dorsolateral prefrontal cortex haemodynamic response']","['sitting/standing/stepping', 'active break intervention', 'six-week simple or cognitively engaging active break intervention']","['enjoyment, physical exertion and mental exertion related to the active breaks', 'brain efficiency', 'response inhibition, lapses of attention, working memory, event-related brain haemodynamic response (dorsolateral prefrontal cortex', 'cognition/brain activity', 'sitting and increase standing/stepping and improve on-task behaviour', 'response inhibition, lapses of attention, working memory', 'sitting, standing, and moving patterns and on-task behaviour', 'levels of enjoyment of active breaks', 'response inhibition via a change in sitting and standing time']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205448', 'cui_str': '2'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",141.0,0.017767,There was a significantly greater positive change in the proportion of deoxygenated haemoglobin in the left dorsolateral prefrontal cortex of children assigned to cognitively engaging active breaks compared to the control group (B =,"[{'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Mazzoli', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Faculty of Health, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Faculty of Health, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Wei-Peng', 'Initials': 'WP', 'LastName': 'Teo', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Faculty of Health, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Pesce', 'Affiliation': ""Department of Movement, Human and Health Sciences, Università degli Studi di Roma 'Foro Italico', Rome, Italy.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Sackler Institute for Translational Neurodevelopment, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Tal Dotan', 'Initials': 'TD', 'LastName': 'Ben-Soussan', 'Affiliation': 'Research Institute for Neuroscience, Education and Didactics, Cognitive Neurophysiology Laboratory, Patrizio Paoletti Foundation, Assisi, Italy.'}, {'ForeName': 'Lisa Michele', 'Initials': 'LM', 'LastName': 'Barnett', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Health and Social Development, Faculty of Health, Deakin University, Geelong, VIC, Australia.'}]",PloS one,['10.1371/journal.pone.0253733']
898,34269720,"A Randomized, Multicenter, Open-Label, Blinded End Point, Phase 2, Feasibility, Efficacy, and Safety Trial of Preoperative Microvascular Protection in Patients Undergoing Major Abdominal Surgery.","BACKGROUND


The endothelial glycocalyx, a carbohydrate-rich layer coating all endothelial surfaces, plays a fundamental role in the function of microcirculation. The primary aim of this study was to evaluate the feasibility of using dexamethasone and albumin to protect the endothelial glycocalyx in patients undergoing abdominal surgery. Secondary and exploratory outcomes included efficacy and safety.
METHODS


We conducted a multicenter, open-label, blinded end point, phase 2, randomized trial. Patients undergoing colorectal, pancreas, or liver surgery were recruited and randomized to receive either intravenous dexamethasone (16 mg) and 20% albumin (100 mL) at induction of anesthesia, then 200 mL of 20% albumin with each subsequent 1000 mL of crystalloid administered (dexamethasone and albumin [Dex-Alb] group), or crystalloid fluid only with no dexamethasone (control group). Feasibility end points included patient recruitment and retention, consent rate, and successful study drug administration. The primary efficacy end point was the measurement of plasma syndecan-1 level on postoperative day (POD) 1, and secondary end points were heparan sulfate levels and inflammatory markers measured at 4 perioperative timepoints. Safety end points included errors in administration of the intervention, hyperglycemia, occurrence of postoperative complications, and patient retention.
RESULTS


Seventy-two patients were randomized. All feasibility end points were achievable. There were no statistically significant differences observed in median (interquartile range) syndecan-1 levels on POD 1 (39 ng·mL-1 [20-97] in the Dex-Alb group versus 41 ng·mL-1 [19-84] in the control group; difference in medians -2.1, 95% confidence interval [CI], -13 to 8.6; P = .69). The Dex-Alb group had lower POD 1 heparan sulfate levels (319 ng·mL-1 [161-717] in the Dex-Alb group versus 1422 [670-2430] ng·mL-1 in the control group; difference in medians -1085, 95% CI, -1779 to -391) and C-reactive protein (CRP) levels on POD 1 (48 [29-77] mg·L-1 in the Dex-Alb group versus 85 mg·L-1 [49-133] in the control group; difference in medians -48, 95% CI, -75 to -21). Fewer patients had one or more postoperative complication in the Dex-Alb group than in the control group (6 [17%] vs 18 patients [50%]; odds ratio = 0.2, 95% CI, 0.06-0.6).
CONCLUSIONS


Intravenous dexamethasone and albumin administration was feasible but did not reduce syndecan-1 on POD 1 in patients undergoing abdominal surgery. Given the clinically important CIs observed between the groups for heparan sulfate, CRP, and postoperative complications, a larger trial assessing the associations between dexamethasone and albumin administration and these outcomes is warranted.",2021,Intravenous dexamethasone and albumin administration was feasible but did not reduce syndecan-1 on POD 1 in patients undergoing abdominal surgery.,"['Patients undergoing colorectal, pancreas, or liver surgery', 'patients undergoing abdominal surgery', 'Patients Undergoing Major Abdominal Surgery', '670-2430', 'Seventy-two patients were randomized']","['Preoperative Microvascular Protection', 'intravenous dexamethasone', 'dexamethasone', 'dexamethasone and albumin', '20% albumin (100 mL) at induction of anesthesia, then 200 mL of 20% albumin with each subsequent 1000 mL of crystalloid administered (dexamethasone and albumin [Dex-Alb] group), or crystalloid fluid only with no dexamethasone (control group', 'Intravenous dexamethasone and albumin administration']","['median (interquartile range) syndecan-1 levels on POD 1', 'efficacy and safety', 'C-reactive protein (CRP) levels', 'patient recruitment and retention, consent rate, and successful study drug administration', 'measurement of plasma syndecan-1 level on postoperative day (POD) 1, and secondary end points were heparan sulfate levels and inflammatory markers', 'errors in administration of the intervention, hyperglycemia, occurrence of postoperative complications, and patient retention', 'POD 1 heparan sulfate levels', 'postoperative complication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0193373', 'cui_str': 'Operation on liver'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C4319632', 'cui_str': '72'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1293861', 'cui_str': 'Administration of albumin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0019143', 'cui_str': 'Heparan sulfate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",72.0,0.56329,Intravenous dexamethasone and albumin administration was feasible but did not reduce syndecan-1 on POD 1 in patients undergoing abdominal surgery.,"[{'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'From the Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Shervin H', 'Initials': 'SH', 'LastName': 'Tosif', 'Affiliation': 'Department of Anaesthesia, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine (Austin Health) & Melbourne Brain Centre at Royal Melbourne Hospital, Melbourne Medical School Faculty of Medicine, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Yee', 'Affiliation': 'Department of Anaesthesia, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'From the Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Gunn', 'Affiliation': 'Department of Anaesthesia, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesia, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Krizhanovskii', 'Affiliation': 'Department of Research, Södertälje Hospital, Södertälje, Sweden.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hahn', 'Affiliation': ""Karolinska Institute at Danderyd's Hospital (KIDS), Stockholm, Sweden.""}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Riedel', 'Affiliation': 'Department of Anaesthesia, Perioperative and Pain Medicine, Peter MacCallum Cancer Centre; and the Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Weinberg', 'Affiliation': 'Department of Critical Care, University of Melbourne, Melbourne, Australia.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005667']
899,34269090,Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation.,"BACKGROUND/AIMS


The Pediatric Research Equity Act and Best Pharmaceuticals for Children Act are intended to promote the conduct of clinical trials that generate pediatric-specific evidence about drug safety and efficacy. This study assesses the quality of evidence generated through Pediatric Research Equity Act-mandated and Best Pharmaceuticals for Children Act-incentivized clinical trials of hematology/oncology drugs and characterizes subsequent changes in pediatric drug utilization rates.
METHODS


Trial characteristics (blinding, randomization, and comparator group) were determined for clinical trials that supported pediatric label changes. Using data from OptumLabs ®  Data Warehouse, a de-identified administrative claims database, we calculated pediatric utilization rates for each drug. We calculated monthly utilization rates from January 2003 (or from the first month in which data were available) to December 2018.
RESULTS


We identified 11 hematology/oncology drugs that underwent pediatric label changes under the Pediatric Research Equity Act Pediatric Research Equity Act and/or Best Pharmaceuticals for Children Act, and we identified 15 trials supporting these changes. Of these trials, 36% (5/14) were randomized, 31% (4/13) were blinded, and 36% (5/14) used a comparator group. A median of 49 children (interquartile range 29.5) received the drug under investigation across these trials. Pediatric label changes were not associated with subsequent changes in pediatric drug utilization. Although some drugs saw increased pediatric use after gaining new pediatric indications, this pattern was not consistently observed. In addition, there was no evidence to suggest that drugs were utilized less frequently after they failed to receive pediatric indications.
CONCLUSIONS


Clinical trials of hematology/oncology drugs conducted under the Pediatric Research Equity Act Pediatric Research Equity Act and Best Pharmaceuticals for Children Act generally have low methodological rigor, and the resulting label changes are not consistently associated with changes in pediatric utilization. Alternative regulatory strategies and study designs may be necessary to maximize the impact of newly generated knowledge on drug utilization.",2021,Pediatric label changes were not associated with subsequent changes in pediatric drug utilization.,"['pediatric hematology/oncology prescribing', '49 children (interquartile range 29.5']",[],[],"[{'cui': 'C1518927', 'cui_str': 'Pediatric hematology oncology'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",[],[],,0.113335,Pediatric label changes were not associated with subsequent changes in pediatric drug utilization.,"[{'ForeName': 'Tyler J', 'Initials': 'TJ', 'LastName': 'Benning', 'Affiliation': 'Mayo Clinic Alix School of Medicine, Rochester, MN, USA.'}, {'ForeName': 'Nilay D', 'Initials': 'ND', 'LastName': 'Shah', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Inselman', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': 'Van Houten', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Ross', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.'}, {'ForeName': 'Kirk D', 'Initials': 'KD', 'LastName': 'Wyatt', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN, USA.'}]","Clinical trials (London, England)",['10.1177/17407745211030683']
900,34271286,Randomized clinical trial comparing helmet continuous positive airway pressure (hCPAP) to facemask continuous positive airway pressure (fCPAP) for the treatment of acute respiratory failure in the emergency department.,"STUDY OBJECTIVE


To determine whether non-invasive ventilation (NIV) delivered by helmet continuous positive airway pressure (hCPAP) is non-inferior to facemask continuous positive airway pressure (fCPAP) in patients with acute respiratory failure in the emergency department (ED).
METHODS


Non-inferiority randomized, clinical trial involving patients presenting with acute respiratory failure conducted in the ED of a local hospital. Participants were randomly allocated to receive either hCPAP or fCPAP as per the trial protocol. The primary endpoint was respiratory rate reduction. Secondary endpoints included discomfort, improvement in Dyspnea and Likert scales, heart rate reduction, arterial blood oxygenation, partial pressure of carbon dioxide (PaCO2), dryness of mucosa and intubation rate.
RESULTS


224 patients were included and randomized (113 patients to hCPAP, 111 to fCPAP). Both techniques reduced respiratory rate (hCPAP: from 33.56 ± 3.07 to 25.43 ± 3.11 bpm and fCPAP: from 33.46 ± 3.35 to 27.01 ± 3.19 bpm), heart rate (hCPAP: from 114.76 ± 15.5 to 96.17 ± 16.50 bpm and fCPAP: from 115.07 ± 14.13 to 101.19 ± 16.92 bpm), and improved dyspnea measured by both the Visual Analogue Scale (hCPAP: from 16.36 ± 12.13 to 83.72 ± 12.91 and fCPAP: from 16.01 ± 11.76 to 76.62 ± 13.91) and the Likert scale. Both CPAP techniques improved arterial oxygenation (PaO 2  from 67.72 ± 8.06 mmHg to 166.38 ± 30.17 mmHg in hCPAP and 68.99 ± 7.68 mmHg to 184.49 ± 36.38 mmHg in fCPAP) and the PaO2:FiO2 (Partial pressure of arterial oxygen: Fraction of inspired oxygen) ratio from 113.6 ± 13.4 to 273.4 ± 49.5 in hCPAP and 115.0 ± 12.9 to 307.7 ± 60.9 in fCPAP. The intubation rate was lower with hCPAP (4.4% for hCPAP versus 18% for fCPAP, absolute difference -13.6%, p = 0.003). Discomfort and dryness of mucosa were also lower with hCPAP.
CONCLUSION


In patients presenting to the ED with acute cardiogenic pulmonary edema or decompensated COPD, hCPAP was non-inferior to fCPAP and resulted in greater comfort levels and lower intubation rate.",2021,Both CPAP techniques improved arterial oxygenation (PaO 2  from 67.72 ± 8.06 mmHg to 166.38 ± 30.17 mmHg in hCPAP and 68.99 ± 7.68 mmHg to 184.49 ± 36.38 mmHg in fCPAP) and the PaO2:FiO2 (Partial pressure of arterial oxygen: Fraction of inspired oxygen) ratio from 113.6 ± 13.4 to 273.4 ± 49.5 in hCPAP and 115.0 ± 12.9 to 307.7 ± 60.9 in fCPAP.,"['patients presenting to the ED with acute cardiogenic pulmonary edema or decompensated COPD', '224 patients were included and randomized (113 patients to hCPAP, 111 to fCPAP', 'hCPAP: from 114.76 ± 15.5 to 96.17 ± 16.50 bpm and fCPAP: from 115.07 ± 14.13 to 101.19 ± 16.92 bpm), and improved dyspnea measured by both the Visual Analogue Scale (hCPAP: from 16.36 ± 12.13 to 83.72 ± 12.91 and fCPAP: from 16.01 ± 11.76 to 76.62 ± 13.91) and the Likert scale', 'patients with acute respiratory failure in the emergency department (ED', 'patients presenting with acute respiratory failure conducted in the ED of a local hospital', 'acute respiratory failure in the emergency department']","['facemask continuous positive airway pressure (fCPAP', 'hCPAP or fCPAP', 'non-invasive ventilation (NIV) delivered by helmet continuous positive airway pressure (hCPAP', 'helmet continuous positive airway pressure (hCPAP', 'hCPAP']","['Discomfort and dryness of mucosa', 'heart rate', 'comfort levels and lower intubation rate', 'intubation rate', 'arterial oxygenation', 'discomfort, improvement in Dyspnea and Likert scales, heart rate reduction, arterial blood oxygenation, partial pressure of carbon dioxide (PaCO2), dryness of mucosa and intubation rate', 'respiratory rate', 'respiratory rate reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0398350', 'cui_str': 'Acute cardiac pulmonary edema'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",224.0,0.139479,Both CPAP techniques improved arterial oxygenation (PaO 2  from 67.72 ± 8.06 mmHg to 166.38 ± 30.17 mmHg in hCPAP and 68.99 ± 7.68 mmHg to 184.49 ± 36.38 mmHg in fCPAP) and the PaO2:FiO2 (Partial pressure of arterial oxygen: Fraction of inspired oxygen) ratio from 113.6 ± 13.4 to 273.4 ± 49.5 in hCPAP and 115.0 ± 12.9 to 307.7 ± 60.9 in fCPAP.,"[{'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Adi', 'Affiliation': 'Raja Permaisuri Bainun Hospital, Resuscitation & Emergency Critical Care Unit, Trauma & Emergency Department, Hospital Raja Permaisuri Bainun, Jalan Raja Ashman (Jalan Hospital), 30450 Ipoh, Perak, Malaysia. Electronic address: adiosman151072@gmail.com.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Via', 'Affiliation': 'Cardiac Anesthesia & Intensive Care - Cardiocentro Ticino, Lugano, Switzerland. Electronic address: gabriele.via@gmail.com.'}, {'ForeName': 'Siti Hafsah', 'Initials': 'SH', 'LastName': 'Salleh', 'Affiliation': 'Raja Permaisuri Bainun Hospital, Trauma & Emergency Department, Hospital Slim River, Slim River, Perak, Malaysia. Electronic address: cthafsah79@gmail.com.'}, {'ForeName': 'Tan Wan', 'Initials': 'TW', 'LastName': 'Chuan', 'Affiliation': 'Raja Permaisuri Bainun Hospital, Trauma & Emergency Department, Hospital Raja Permaisuri Bainun, Jalan Raja Ashman (Jalan Hospital), 30450 Ipoh, Perak, Malaysia. Electronic address: tanonexam@yahoo.com.'}, {'ForeName': 'Jamalludin Ab', 'Initials': 'JA', 'LastName': 'Rahman', 'Affiliation': 'International Islamic University, Department of Community Medicine, Faculty of Medicine, Kuantan, Pahang, Malaysia. Electronic address: arjamal@gmail.com.'}, {'ForeName': 'Nik Azlan Nik', 'Initials': 'NAN', 'LastName': 'Muhammad', 'Affiliation': 'Department of Emergency Medicine, National University of Malaysia, Cheras, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rafidah', 'Initials': 'R', 'LastName': 'Atan', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Malaysia Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Malaysia. Electronic address: rafidah.atan@ummc.edu.my.'}, {'ForeName': ""Nor'azim M"", 'Initials': 'NM', 'LastName': 'Yunos', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Malaysia Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Malaysia. Electronic address: norazim@um.edu.my.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.06.031']
901,34273676,A causal role of estradiol in human reinforcement learning.,"The sex hormone estradiol is hypothesized to play a key role in human cognition, and reward processing specifically, via increased dopamine D1-receptor signalling. However, the effect of estradiol on reward processing in men has never been established. To fill this gap, we performed a double-blind placebo-controlled study in which men (N = 100) received either a single dose of estradiol (2 mg) or a placebo. Subjects performed a probabilistic reinforcement learning task where they had to choose between two options with varying reward probabilities to maximize monetary reward. Results showed that estradiol administration increased reward sensitivity compared to placebo. This effect was observed in subjects' choices, how much weight they assigned to their previous choices, and subjective reports about the reward probabilities. Furthermore, effects of estradiol were moderated by reward sensitivity, as measured through the BIS/BAS questionnaire. Using reinforcement learning models, we found that behavioral effects of estradiol were reflected in increased learning rates. These results demonstrate a causal role of estradiol within the framework of reinforcement learning, by enhancing reward sensitivity and learning. Furthermore, they provide preliminary evidence for dopamine-related genetic variants moderating the effect of estradiol on reward processing.",2021,"This effect was observed in subjects' choices, how much weight they assigned to their previous choices, and subjective reports about the reward probabilities.","['men (N\xa0=\xa0100', 'human reinforcement learning']","['probabilistic reinforcement learning task', 'estradiol', 'placebo']","['learning rates', 'reward sensitivity, as measured through the BIS/BAS questionnaire', 'reward sensitivity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.117211,"This effect was observed in subjects' choices, how much weight they assigned to their previous choices, and subjective reports about the reward probabilities.","[{'ForeName': 'Sebastijan', 'Initials': 'S', 'LastName': 'Veselic', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Austria; Department of Clinical and Movement Neurosciences, University College London, London, UK; Wellcome Centre for Human Neuroimaging, University College London, London, UK. Electronic address: sebastijan.veselic.18@ucl.ac.uk.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Jocham', 'Affiliation': 'Biological Psychology of Decision Making, Institute of Experimental Psychology, Heinrich Heine University Düsseldorf, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gausterer', 'Affiliation': 'FDZ-Forensisches DNA Zentrallabor GmbH, Medical University of Vienna, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Laboratory for Chromatographic & Spectrometric Analysis, FH JOANNEUM, Graz, Austria.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ernhoefer-Reßler', 'Affiliation': 'Laboratory for Chromatographic & Spectrometric Analysis, FH JOANNEUM, Graz, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Lanzenberger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Eisenegger', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Austria; Vienna Cognitive Science Hub, University of Vienna, Austria.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Losecaat Vermeer', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Austria; Department of Decision Neuroscience and Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke, Germany; Charité-Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany. Electronic address: annabel.losecaat.vermeer@univie.ac.at.'}]",Hormones and behavior,['10.1016/j.yhbeh.2021.105022']
902,34274407,Differential loss of β-cell function in youth vs. adults following treatment withdrawal in the Restoring Insulin Secretion (RISE) study.,"AIMS


To compare OGTT-derived estimates of β-cell function between youth and adults with impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes after treatment discontinuation in RISE.
METHODS


Youth (n = 89) and adults (n = 132) were randomized to 3 months glargine followed by 9 months metformin (G/M) or 12 months metformin (MET). Insulin sensitivity and β-cell responses were estimated from 3-hour OGTTs over 21 months. Linear mixed models tested for differences by time and age group within each treatment arm.
RESULTS


After treatment withdrawal, HbA1c increased in both youth and adults with a larger net increase in G/M youth vs. adults at 21 months. Among youth, β-cell function decreased starting at 12 months in G/M and 15 months in MET. Among adults, β-cell function remained relatively stable although insulin secretion rates decreased in G/M at 21 months. At 21 months vs. baseline β-cell function declined to a greater extent in youth vs. adults in both the G/M and MET treatment arms.
CONCLUSIONS


After treatment withdrawal youth demonstrated progressive decline in β-cell function after stopping treatment with either G/M or MET. In contrast, β-cell function in adults remained stable despite an increase in HbA1c over time. ClinicalTrials.gov Identifier: NCT01779375 and NCT01779362 at clinical trials.gov.",2021,"After treatment withdrawal, HbA1c increased in both youth and adults with a larger net increase in G/M youth vs. adults at 21 months.","['youth and adults with impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes after treatment discontinuation in RISE', 'Youth (n=89) and adults (n=132', 'Youth vs. Adults']",['glargine followed by 9 months metformin (G/M) or 12 months metformin (MET'],"['Insulin sensitivity and β-cell responses', 'β-cell function', 'Differential Loss of β-cell Function', 'insulin secretion rates']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",132.0,0.226326,"After treatment withdrawal, HbA1c increased in both youth and adults with a larger net increase in G/M youth vs. adults at 21 months.","[{'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'VA Puget Sound Health Care System, Seattle, WA, United States; Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Tripputi', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, MD, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kozedub', 'Affiliation': 'VA Puget Sound Health Care System, Seattle, WA, United States.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barengolts', 'Affiliation': 'Jesse Brown VA Medical Center, Chicago, IL, United States.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Department of Pediatrics, Yale University, New Haven, CT, United States.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cree-Green', 'Affiliation': ""University of Colorado Anschutz Medical Campus/Children's Hospital Colorado, Denver, CO, United States.""}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, MD, United States.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, MD, United States.'}, {'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'VA Puget Sound Health Care System, Seattle, WA, United States; Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus/Children's Hospital Colorado, Denver, CO, United States.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2021.108948']
903,34278555,"Cost-Effectiveness of Therapeutic Drug Monitoring-Guided Adalimumab Therapy in Rheumatic Diseases: A Prospective, Pragmatic Trial.","INTRODUCTION


To assess the clinical and cost-effectiveness of therapeutic drug monitoring (TDM) based on serum adalimumab levels compared to standard of care in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
METHODS


This was a non-inferiority, multicentric, non-randomized, pragmatic trial including adult patients diagnosed with moderate-to-severe, clinically stable rheumatic diseases treated with adalimumab. Consecutive patients were assigned 1:2 to the control (CG) or the intervention group (IG), based on the site of inclusion, and followed up for 18 months. Adalimumab serum levels were measured at each study visit and released to the IG only to modify dosing strategy. Data on disease activity, healthcare resource utilization and health-related quality of life (HRQoL) measured through the EQ-5D-5L were collected. Number of persistent and overall flares, time to first flare, days experiencing high disease activity, total direct costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated.
RESULTS


Of the 169 recruited patients, 150 were included in the analysis (52 and 98 patients in the CG and IG, respectively). The primary endpoint was not met as persistent flares were not significantly lower in the IG, although mean (SD) number of flares was numerically lower in the IG (0.67 [0.70] versus 0.90 [0.82], P = 0.073), respectively. Based on EQ-5D-5L utilities, HRQoL was significantly higher in the IG at 3 (P = 0.001) and 6 months (P = 0.035), which overall translated into 0.075 QALYs gained per patient for the IG at month 18. Overall, direct costs were significantly lower for the IG patients (€15,311.59 [4,870.04] versus €17,378.46 [6,556.51], P = 0.030), resulting in the intervention being dominant, leading to increased QALY at a lower overall cost CONCLUSION: Adalimumab dose tapering based on TDM for rheumatic patients led to an increased quality of life and QALY gain and entailed lower costs, being a more cost-effective alternative than clinically guided management.",2021,"Overall, direct costs were significantly lower for the IG patients (€15,311.59 [4,870.04] versus €17,378.46 [6,556.51], P = 0.030), resulting in the intervention being dominant, leading to increased QALY at a lower overall cost CONCLUSION:","['patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis', 'adult patients diagnosed with moderate-to-severe, clinically stable rheumatic diseases treated with', 'Rheumatic Diseases', '169 recruited patients']","['adalimumab', 'Adalimumab', 'therapeutic drug monitoring (TDM', 'Therapeutic Drug Monitoring-Guided Adalimumab Therapy']","['disease activity, healthcare resource utilization and health-related quality of life (HRQoL', 'quality of life and QALY gain and entailed lower costs', 'Number of persistent and overall flares, time to first flare, days experiencing high disease activity, total direct costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER', 'Overall, direct costs', 'Adalimumab serum levels', 'persistent flares', 'EQ-5D-5L utilities, HRQoL', 'mean (SD) number of flares']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1720825', 'cui_str': 'Therapeutic Drug Monitoring'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4302634', 'cui_str': 'Adalimumab therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",169.0,0.0866879,"Overall, direct costs were significantly lower for the IG patients (€15,311.59 [4,870.04] versus €17,378.46 [6,556.51], P = 0.030), resulting in the intervention being dominant, leading to increased QALY at a lower overall cost CONCLUSION:","[{'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Gómez-Arango', 'Affiliation': 'Department of Rheumatology, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.'}, {'ForeName': 'Inigo', 'Initials': 'I', 'LastName': 'Gorostiza', 'Affiliation': 'Research Unit, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Úcar', 'Affiliation': 'Department of Rheumatology, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.'}, {'ForeName': 'Maria Luz', 'Initials': 'ML', 'LastName': 'García-Vivar', 'Affiliation': 'Department of Rheumatology, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.'}, {'ForeName': 'Clara Eugenia', 'Initials': 'CE', 'LastName': 'Pérez', 'Affiliation': 'Department of Rheumatology, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.'}, {'ForeName': 'Juan Ramon', 'Initials': 'JR', 'LastName': 'De Dios', 'Affiliation': 'Department of Rheumatology, Osakidetza Basque Health Service, Araba University Hospital, Vitoria, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Alvarez', 'Affiliation': 'Department of Rheumatology, Osakidetza Basque Health Service, Araba University Hospital, Vitoria, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ruibal-Escribano', 'Affiliation': 'Department of Rheumatology, Osakidetza Basque Health Service, Araba University Hospital, Vitoria, Spain.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Stoye', 'Affiliation': 'Department of Rheumatology, Osakidetza Basque Health Service, Araba University Hospital, Vitoria, Spain.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Vasques', 'Affiliation': 'Department of Rheumatology, Osakidetza Basque Health Service, Araba University Hospital, Vitoria, Spain.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Belzunegui', 'Affiliation': 'Department of Rheumatology, Osakidetza Basque Health Service, Donostia University Hospital, San Sebastian, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Escobar', 'Affiliation': 'Research Unit, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.'}, {'ForeName': 'Ziortza', 'Initials': 'Z', 'LastName': 'Trancho', 'Affiliation': 'Research Unit, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.'}, {'ForeName': 'Ainhoa', 'Initials': 'A', 'LastName': 'Ruiz Del Agua', 'Affiliation': 'R&D Department, Progenika Biopharma S.A., A Grifols Company, 504 Parque Tecnológico Bizkaia, 48160, Derio, Spain.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Del Rio', 'Affiliation': 'R&D Department, Progenika Biopharma S.A., A Grifols Company, 504 Parque Tecnológico Bizkaia, 48160, Derio, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Jorquera', 'Affiliation': 'Research Unit, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Diez', 'Affiliation': 'R&D Department, Progenika Biopharma S.A., A Grifols Company, 504 Parque Tecnológico Bizkaia, 48160, Derio, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Martínez', 'Affiliation': 'R&D Department, Progenika Biopharma S.A., A Grifols Company, 504 Parque Tecnológico Bizkaia, 48160, Derio, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nagore', 'Affiliation': 'R&D Department, Progenika Biopharma S.A., A Grifols Company, 504 Parque Tecnológico Bizkaia, 48160, Derio, Spain. daniel.nagore@progenika.grifols.com.'}]",Rheumatology and therapy,['10.1007/s40744-021-00345-5']
904,34283040,Patient Satisfaction Through an Immersive Experience Using a Mobile Phone-Based Head-Mounted Display During Arthroscopic Knee Surgery Under Spinal Anesthesia: A Randomized Clinical Trial.,"BACKGROUND


Patient satisfaction is an important element of high-quality health care. Virtual reality has been studied for its sedative and analgesic effects, as it immerses the patient into an artificial interactive environment. Deriving from this concept, we hypothesized that an immersive experience that engulfs the senses with noninteractive visual and auditory stimuli would have a positive effect on satisfaction and anxiety in patients undergoing spinal anesthesia.
METHODS


We enrolled and randomized 90 patients undergoing spinal anesthesia for arthroscopic knee surgery into an immersive experience arm and an intravenous midazolam sedation arm. The immersive experience was provided through a mobile phone-based head-mounted display showing binocular monoscopic video and noise-canceling headphones playing audio. The primary outcome measure was postoperative satisfaction, measured using a visual analog scale and compared using the Mann-Whitney U test; secondary outcomes included anxiety score (measured using the 6-item State-Trait Anxiety Inventory), hemodynamic stability, and additional sedative requirement.
RESULTS


The visual analog scale satisfaction score with immersive experience was significantly higher than with midazolam (median [interquartile range {IQR}] of 93 [82-98] and 80 [73-93], respectively, P = .004), with Hodges-Lehmann median difference estimate of 7 (95% confidence interval, 3-14). The change in anxiety scores from the preoperative to postoperative period between the groups was not significantly different (P = .08), with a Hodges-Lehmann median difference estimate of 3.3 (95% confidence interval, 0-6.7). All patients were hemodynamically stable, were without significant adverse events, and did not require additional sedatives.
CONCLUSIONS


We have found that an immersive experience is an effective and acceptable intraoperative alternative to pharmacological sedation in patients undergoing arthroscopic knee surgery under spinal anesthesia, with higher satisfaction levels and no detected difference in preoperative to postoperative anxiolytic effect.",2021,"The change in anxiety scores from the preoperative to postoperative period between the groups was not significantly different (P = .08), with a Hodges-Lehmann median difference estimate of 3.3 (95% confidence interval, 0-6.7).","['patients undergoing arthroscopic knee surgery under spinal anesthesia', '90 patients undergoing', 'patients undergoing spinal anesthesia']","['mobile phone-based head-mounted display showing binocular monoscopic video and noise-canceling headphones playing audio', 'Immersive Experience Using a Mobile Phone-Based Head-Mounted Display During Arthroscopic Knee Surgery Under Spinal Anesthesia', 'midazolam', 'spinal anesthesia', 'arthroscopic knee surgery into an immersive experience arm and an intravenous midazolam sedation arm']","['postoperative satisfaction, measured using a visual analog scale and compared using the Mann-Whitney U test; secondary outcomes included anxiety score (measured using the 6-item State-Trait Anxiety Inventory), hemodynamic stability, and additional sedative requirement', 'change in anxiety scores', 'visual analog scale satisfaction score with immersive experience', 'satisfaction and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4082765', 'cui_str': 'Arthroscopic knee operation'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5197728', 'cui_str': 'Head Worn Display'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205544', 'cui_str': 'Canceled'}, {'cui': 'C0441067', 'cui_str': 'Earphones'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4082765', 'cui_str': 'Arthroscopic knee operation'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",90.0,0.268676,"The change in anxiety scores from the preoperative to postoperative period between the groups was not significantly different (P = .08), with a Hodges-Lehmann median difference estimate of 3.3 (95% confidence interval, 0-6.7).","[{'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Tharion', 'Affiliation': 'From the Department of Anaesthesia, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Suniti', 'Initials': 'S', 'LastName': 'Kale', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005666']
905,34286901,The effect of immediate dentin sealing with chlorhexidine pretreatment on the shear bond strength of dual-cure adhesive cement.,"The purpose of this in vitro study was to evaluate the effect of immediate dentin sealing (IDS) with and without chlorhexidine (CHX) pretreatment on the shear bond strength (SBS) of dual-cure adhesive resin cement. Mid-coronal dentin surfaces were obtained from 75 human molars. They were randomly allocated into five groups in accordance to type of IDS [etch&rinse/ER (Adper Single Bond2) and universal/U adhesive systems (Single Bond Universal)] and presence of CHX application (n = 15): Group ER; Group ER + CHX; Group U; Group U + CHX; and Group C (no IDS). Dual-cure adhesive resin cements were bonded with a cylinder-shaped Teflon mold. The SBS was measured using a universal test machine. Fracture type was evaluated with stereomicroscope. The resin/dentin interfaces were examined with an environmental scanning electron microscope. Data were statistically analyzed with two-way analysis of variance and Bonferroni tests (p < .05). Regarding the IDS treatment groups with/without CHX, there were no significant differences in SBS (p > .05). Group U + CHX showed significantly higher SBS than Group C (p < .05). Regarding the presence of CHX, no significant differences in SBS were found (p > .05). The prevalent failure mode was the mixed type for most of the groups. Group C exhibited an intact and regular hybrid layer with no resin tag, whereas longer and clear resin-tag formation was visible for Group U + CHX. CHX pretreatment improved the bond strength between adhesive resin cement and dentin when IDS treatment was performed with a universal adhesive system.",2021,CHX pretreatment improved the bond strength between adhesive resin cement and dentin when IDS treatment was performed with a universal adhesive system.,['75 human molars'],"['IDS [etch&rinse/ER (Adper Single Bond2) and universal/U adhesive systems (Single Bond Universal)] and presence of CHX application (n = 15): Group ER; Group ER\u2009+\u2009CHX; Group U; Group U\u2009+\u2009CHX; and Group C (no IDS', 'immediate dentin sealing (IDS) with and without chlorhexidine (CHX', 'CHX', 'chlorhexidine']","['shear bond strength (SBS', 'SBS', 'shear bond strength of dual-cure adhesive cement', 'bond strength']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0759863', 'cui_str': 'single bond'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441854', 'cui_str': 'Group U'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0382302', 'cui_str': 'Adhesive cement'}]",,0.0368742,CHX pretreatment improved the bond strength between adhesive resin cement and dentin when IDS treatment was performed with a universal adhesive system.,"[{'ForeName': 'Sule Tugba', 'Initials': 'ST', 'LastName': 'Deniz', 'Affiliation': 'Faculty of Dentistry, Department of Prosthodontics, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Oglakci', 'Affiliation': 'Faculty of Dentistry, Department of Restorative Dentistry, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Sevda Ozturk', 'Initials': 'SO', 'LastName': 'Yesilirmak', 'Affiliation': 'Faculty of Dentistry, Department of Restorative Dentistry, Istanbul Yeni Yuzyil University, Istanbul, Turkey.'}, {'ForeName': 'Evrim Eliguzeloglu', 'Initials': 'EE', 'LastName': 'Dalkilic', 'Affiliation': 'Faculty of Dentistry, Department of Restorative Dentistry, Bezmialem Vakif University, Istanbul, Turkey.'}]",Microscopy research and technique,['10.1002/jemt.23878']
906,34288127,"Effectiveness of portable HEPA air cleaners on reducing indoor endotoxin, PM 10,  and coarse particulate matter in an agricultural cohort of children with asthma: A randomized intervention trial.","We conducted a randomized trial of portable HEPA air cleaners in the homes of children age 6-12 years with asthma in the Yakima Valley, Washington. All families received asthma education while intervention families also received two HEPA cleaners (child's bedroom, living room). We collected 14-day integrated samples of endotoxin in settled dust and PM 10  and PM 10-2.5  in the air of the children's bedrooms at baseline and one-year follow-up, and used linear regression to compare follow-up levels, adjusting for baseline. Seventy-one families (36 HEPA, 35 control) completed the study. Baseline geometric mean (GSD) endotoxin loadings were 1565 (6.3) EU/m 2  and 2110 (4.9) EU/m 2  , respectively, in HEPA vs. control homes while PM 10  and PM 10-2.5  were 22.5 (1.9) μg/m 3  and 9.5 (2.9) μg/m 3  , respectively, in HEPA homes, and 19.8 (1.8) μg/m 3  and 7.7 (2.0) μg/m 3  , respectively, in control homes. At follow-up, HEPA families had 46% lower (95% CI, 31%-57%) PM 10  on average than control families, consistent with prior studies. In the best-fit heterogeneous slopes model, HEPA families had 49% (95% CI, 6%-110%) and 89% lower (95% CI, 28%-177%) PM 10-2.5  at follow-up, respectively, at 50th and 75th percentile baseline concentrations. Endotoxin loadings did not differ significantly at follow-up (4% lower, HEPA homes; 95% CI, -87% to 50%).",2021,"Endotoxin loadings did not differ significantly at follow-up (4% lower, HEPA homes; 95% CI, -87% to 50%).","['homes of children age 6-12\xa0years with asthma in the Yakima Valley, Washington', 'children with asthma', 'Seventy-one families (36 HEPA, 35 control) completed the study']",['portable HEPA air cleaners'],"['indoor endotoxin, PM 10,  and coarse particulate matter', 'Endotoxin loadings', 'Baseline geometric mean (GSD) endotoxin loadings']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0574583', 'cui_str': 'Yakima language'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0789995', 'cui_str': 'Air cleaner'}]","[{'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0205194', 'cui_str': 'Coarse'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.121823,"Endotoxin loadings did not differ significantly at follow-up (4% lower, HEPA homes; 95% CI, -87% to 50%).","[{'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Riederer', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Krenz', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Tchong-French', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Torres', 'Affiliation': 'Northwest Communities Education Center, Radio KDNA, Granger, WA, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Yakima Valley Farm Workers Clinic, Toppenish, WA, USA.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Younglove', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jansen', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hardie', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Farquhar', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Sampson', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nervana', 'Initials': 'N', 'LastName': 'Metwali', 'Affiliation': 'Department of Occupational and Environmental Health, College of Public Health, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Thorne', 'Affiliation': 'Department of Occupational and Environmental Health, College of Public Health, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Karr', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}]",Indoor air,['10.1111/ina.12858']
907,34292537,Therapeutic Effects of Ba-Duan-Jin versus Pregabalin for Fibromyalgia Treatment: Protocol for a Randomized Controlled Trial.,"INTRODUCTION


Fibromyalgia is characterized by multi-focal pain and is associated with fatigue, unrefreshing sleep and psychological impairment. Pregabalin is one of the most frequently used agents in fibromyalgia treatment. However, it has failed to demonstrate benefit over placebo for reducing fatigue and psychological impairment, and may cause adverse effects (e.g. somnolence, dizziness). ""Ba-Duan-Jin"" (BDJ) is a common form of ""Qigong"" exercise for health promotion in China. Growing evidence suggests that BDJ may achieve satisfactory control of fibromyalgia-related symptoms in Chinese patients. Therefore, we wish to ascertain if BDJ could overcome the disadvantages of pregabalin.
METHODS


A single-blind randomized controlled trial has been designed which will recruit 104 patients with fibromyalgia (age 18-70 years) with a visual analog scale (VAS) pain score of ≥ 40 mm These patients will be randomly assigned to one of two groups: (1) BDJ group (to undertake guided BDJ exercise and take a placebo capsule) or (2) pregabalin group (to take a pregabalin capsule and receive wellness education and guided muscle-relaxation exercises). The primary endpoint will be changes in the VAS score for pain. The secondary endpoints will be changes in the score for the Revised Fibromyalgia Impact Questionnaire, Multidimensional Fatigue Inventory-20, Pittsburgh Sleep Quality Index, Beck II Depression Inventory, Perceived Stress Scale and Short Form-36 Health Survey Questionnaire. These parameters will be assessed at 0, 4, 8, 12 and 24 weeks of follow-up.
PLANNED OUTCOMES


Our results are expected to provide more clinical evidence for the beneficial effects of BDJ in treating fibromyalgia.
TRIAL REGISTRATION


NCT03797560.",2021,"The secondary endpoints will be changes in the score for the Revised Fibromyalgia Impact Questionnaire, Multidimensional Fatigue Inventory-20, Pittsburgh Sleep Quality Index, Beck II Depression Inventory, Perceived Stress Scale and Short Form-36 Health Survey Questionnaire.","['104 patients with fibromyalgia (age 18-70\xa0years) with a visual analog scale (VAS) pain score of ≥ 40\xa0mm These patients', 'Chinese patients']","['Ba-Duan-Jin versus Pregabalin', 'BDJ', 'Pregabalin', 'BDJ group (to undertake guided BDJ exercise and take a placebo capsule) or (2) pregabalin group (to take a pregabalin capsule and receive wellness education and guided muscle-relaxation exercises', 'placebo', 'Ba-Duan-Jin"" (BDJ']","['VAS score for pain', 'score for the Revised Fibromyalgia Impact Questionnaire, Multidimensional Fatigue Inventory-20, Pittsburgh Sleep Quality Index, Beck II Depression Inventory, Perceived Stress Scale and Short Form-36 Health Survey Questionnaire', 'fatigue and psychological impairment']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0450402', 'cui_str': '40mm'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1660529', 'cui_str': 'pregabalin Oral Capsule'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026836', 'cui_str': 'Muscle relaxation'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",104.0,0.241782,"The secondary endpoints will be changes in the score for the Revised Fibromyalgia Impact Questionnaire, Multidimensional Fatigue Inventory-20, Pittsburgh Sleep Quality Index, Beck II Depression Inventory, Perceived Stress Scale and Short Form-36 Health Survey Questionnaire.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Psychology Department, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yan-Ting', 'Initials': 'YT', 'LastName': 'Li', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yu-Ruo', 'Initials': 'YR', 'LastName': 'Sun', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Clinical Evaluation Centre, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jin-Hua', 'Initials': 'JH', 'LastName': 'Zhang', 'Affiliation': ""Psychology Department, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China. jiao.juan@hotmail.com.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China. jiang.quan@hotmail.com.""}]",Rheumatology and therapy,['10.1007/s40744-021-00341-9']
908,34302228,Intervention mediating effects of self-efficacy on patient physical and psychological health following ICD implantation.,"This study examined mechanisms by which social cognitive theory (SCT) interventions influence health outcomes and the importance of involving partners in recovery following the patients' receipt of an initial implantable cardioverter defibrillator (ICD). We compared direct and indirect intervention effects on patient health outcomes with data from a randomized clinical trial involving two telephone-based interventions delivered during the first 3 months post-ICD implant by experienced trained nurses: P-only conducted only with patients, and P + P conducted with patients and their intimate partners. Each intervention included the patient-focused component. P + P also included a partner-focused intervention component. ICD-specific SCT-derived mediators included self-efficacy expectations, outcome expectations, self-management behavior, and ICD knowledge. Outcomes were assessed at discharge, 3- and 12-months post ICD implant. Patients (N = 301) were primarily Caucasian, male, 64 (± 11.9) years of age with a mean ejection fraction of 34.08 (± 14.3). Intervention effects, mediated through ICD-specific self-efficacy and outcome expectations, were stronger for P + P compared to P-only for physical function (β = 0.04, p = 0.04; β = 0.02, p = 0.04, respectively) and for psychological adjustment (β = 0.06, p = 0.04; β = 0.03, p = 0.04, respectively). SCT interventions show promise for improving ICD patient physical and psychological health outcomes through self-efficacy and outcome expectations. Including partners in post-ICD interventions may potentiate positive outcomes for patients.Trial registration number (TRN): NCT01252615 (Registration date: 12/02/2010).",2021,"Intervention effects, mediated through ICD-specific self-efficacy and outcome expectations, were stronger for P + P compared to P-only for physical function (β = 0.04, p = 0.04; β = 0.02, p = 0.04, respectively) and for psychological adjustment (β = 0.06, p = 0.04; β = 0.03, p = 0.04, respectively).","['by experienced trained nurses: P-only conducted only with patients, and P\u2009+\u2009P conducted with patients and their intimate partners', 'patient physical and psychological health following ICD implantation', 'Patients (N\u2009=\u2009301) were primarily Caucasian, male, 64 (±\u200911.9) years of age with a mean ejection fraction of 34.08 (±\u200914.3']","['telephone-based interventions delivered during the first 3\xa0months post-ICD implant', 'SCT interventions', 'initial implantable cardioverter defibrillator (ICD', 'social cognitive theory (SCT) interventions']","['ICD patient physical and psychological health outcomes', 'ICD-specific self-efficacy and outcome expectations']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",301.0,0.0341791,"Intervention effects, mediated through ICD-specific self-efficacy and outcome expectations, were stronger for P + P compared to P-only for physical function (β = 0.04, p = 0.04; β = 0.02, p = 0.04, respectively) and for psychological adjustment (β = 0.06, p = 0.04; β = 0.03, p = 0.04, respectively).","[{'ForeName': 'Ana C S', 'Initials': 'ACS', 'LastName': 'Liberato', 'Affiliation': 'Evidera PPD Inc., Patient Centered Research, London, UK.'}, {'ForeName': 'Elaine A', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington School of Nursing, 1959 NE Pacific Street, 357266, Seattle, WA, 98195, USA.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Dougherty', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington School of Nursing, 1959 NE Pacific Street, 357266, Seattle, WA, 98195, USA. cindyd@uw.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00244-8']
909,34320426,Photodynamic therapy of vitiligo: A pilot study.,"BACKGROUND


Vitiligo is an acquired autoimmune skin disorder with depigmented macules and patches. There are several possible treatments for vitiligo, none of which could be considered as a definitive cure. Photodynamic therapy (PDT) is a novel treatment with controversial outcomes in vitiligo patients.
MATERIALS & METHODS


A total of 10 patches (5 patches on the trunk, 3 on the extremities, and 2 on the neck) were selected and received microderm abrasion. Then the lesion was covered with 5- aminolevulinic acid (ALA) for one hour. Afterwards, it received red light with a dose of 120 J/cm 2 .This cycle was repeated monthly for 5 sessions. Another vitiligo patch was considered as a control and received topical mometasone twice a day during the study. The therapeutic results were compared by a blind dermatologist.
RESULTS


The median of repigmentation score, which was determined by a blind dermatologist, was 0.5 in the PDT group and 1 in the steroid group, which did not show any statistically significant difference.
CONCLUSION


The results of this study demonstrated that PDT does not have any additional therapeutic effect in comparison with topical corticosteroids as the traditional treatment of vitiligo.",2021,The results of this study demonstrated that PDT does not have any additional therapeutic effect in comparison with topical corticosteroids as the traditional treatment of vitiligo.,"['vitiligo patients', 'Vitiligo']","['microderm abrasion', 'Photodynamic therapy (PDT', 'Photodynamic Therapy', '5- aminolevulinic acid (ALA', 'PDT', 'topical mometasone']",['median of repigmentation score'],"[{'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0399832,The results of this study demonstrated that PDT does not have any additional therapeutic effect in comparison with topical corticosteroids as the traditional treatment of vitiligo.,"[{'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Rahimi', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Shohada-e Tajrish Hospital, Shahrdari St, 1989934148, Tehran, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Zeinali', 'Affiliation': 'School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Tehranchinia', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Shohada-e Tajrish Hospital, Shahrdari St, 1989934148, Tehran, Iran. Electronic address: zohreh_tehranchi@yahoo.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102439']
910,34319914,"Neurocognitive, Quality of Life, and Behavioral Outcomes for Patients With Covert Stroke After Cardiac Surgery: Exploratory Analysis of Data From a Prospectively Randomized Trial.","BACKGROUND


Asymptomatic brain ischemic injury detected with diffusion-weighted magnetic resonance imaging (DWI) is reported in more than one-half of patients after cardiac surgery. There are conflicting findings on whether DWI-detected covert stroke is associated with neurocognitive dysfunction after surgery, and it is unclear whether such ischemic injury affects quality of life or behavioral outcomes. The purpose of this study was to perform exploratory analysis on whether covert stroke after cardiac surgery is associated with delayed neurocognitive recovery 1 month after surgery, impaired quality of life, anxiety, or depression.
METHODS


Analysis of data collected in a prospectively randomized study in patients undergoing cardiac surgery testing whether basing mean arterial pressure (MAP) targets during cardiopulmonary bypass to be above the lower limit of cerebral autoregulation versus usual practices reduces the frequency of adverse neurological outcomes. A neuropsychological testing battery was administered before surgery and then 1 month later. Patients underwent brain magnetic resonance imaging (MRI) between postoperative days 3 and 5. The primary outcome was DWI-detected ischemic lesion; the primary end point was change from baseline in domain-specific neurocognitive Z scores 1 month after surgery. Secondary outcomes included a composite indicator of delayed neurocognitive recovery, quality of life measures, state and trait anxiety, and Beck Depression Inventory scores.
RESULTS


Of the 164 patients with postoperative MRI data, clinical stroke occurred in 10 patients. Of the remaining 154 patients, 85 (55.2%) had a covert stroke. There were no statistically significant differences for patients with or without covert stroke in the change from baseline in Z scores in any of the cognitive domains tested adjusted for sex, baseline cognitive score, and randomization treatment arm. The frequency of delayed neurocognitive recovery (no covert stroke, 15.1%; covert stroke, 17.6%; P = .392), self-reported quality of life measurements, anxiety rating, or depression scores were not different between those with or without DWI ischemic injury.
CONCLUSIONS


More than one-half of patients undergoing cardiac surgery demonstrated covert stroke. In this exploratory analysis, covert stroke was not found to be significantly associated with neurocognitive dysfunction 1 month after surgery; evidence of impaired quality of life, anxiety, or depression, albeit a type II error, cannot be excluded.",2021,"In this exploratory analysis, covert stroke was not found to be significantly associated with neurocognitive dysfunction 1 month after surgery; evidence of impaired quality of life, anxiety, or depression, albeit a type II error, cannot be excluded.","['164 patients with postoperative MRI data', 'patients undergoing cardiac surgery testing whether basing mean arterial pressure (MAP) targets during cardiopulmonary bypass', 'Patients With Covert Stroke']","['diffusion-weighted magnetic resonance imaging (DWI', 'brain magnetic resonance imaging (MRI']","['domain-specific neurocognitive Z scores', 'covert stroke', 'composite indicator of delayed neurocognitive recovery, quality of life measures, state and trait anxiety, and Beck Depression Inventory scores', 'quality of life, anxiety, or depression', 'self-reported quality of life measurements, anxiety rating, or depression scores', 'Neurocognitive, Quality of Life, and Behavioral Outcomes', 'frequency of adverse neurological outcomes', 'DWI-detected ischemic lesion', 'frequency of delayed neurocognitive recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",164.0,0.381286,"In this exploratory analysis, covert stroke was not found to be significantly associated with neurocognitive dysfunction 1 month after surgery; evidence of impaired quality of life, anxiety, or depression, albeit a type II error, cannot be excluded.","[{'ForeName': 'Choy', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Balmert', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine.'}, {'ForeName': 'Liqi', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine.'}, {'ForeName': 'Saadia S', 'Initials': 'SS', 'LastName': 'Sherwani', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Nemeth', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Grafman', 'Affiliation': 'Shirley Ryan Abilitylab and the Department of Rehabilitation and Physical Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gottesman', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesiology & Critical Care, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Hogue', 'Affiliation': 'From the Department of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005690']
911,34274514,Obeticholic Acid Impact on Quality of Life in Patients With Nonalcoholic Steatohepatitis: REGENERATE 18-Month Interim Analysis.,"BACKGROUND & AIMS


Nonalcoholic steatohepatitis (NASH) affects patients' health-related quality of life (HRQoL). Patient-reported outcomes (PROs) evaluating HRQoL were assessed in the RandomizEd Global Phase 3 Study to Evaluate the Impact on NASH with FibRosis of Obeticholic Acid TreatmEnt (REGENERATE) study, which showed that obeticholic acid (OCA) significantly improved fibrosis in patients with NASH.
METHODS


Noncirrhotic NASH patients in a phase 3, double-blind, randomized, placebo-controlled, multicenter, international study of OCA were enrolled. The Chronic Liver Disease Questionnaire-NASH and EuroQol EQ-5D-5L were administered at baseline, 6, 12, and 18 months.
RESULTS


There were 1218 patients (age, 54.1 ± 11.5 y; 57% women; 43% stage F3) in the expanded intent-to-treat population (stages, F1-F3) assigned randomly to 10 mg (N = 407) or 25 mg (N = 404) OCA or placebo (N = 407). Baseline measurements were balanced across treatment groups for EuroQol EQ-5D-5L and Chronic Liver Disease Questionnaire-NASH, including Itch score: 5.75 ± 1.53 (scale 1-7, with 7 representing no itching). Nineteen (1.6%) patients discontinued therapy (protocol mandated) because of grade 3 pruritus. Patients receiving 25 mg OCA experienced mild worsening of itch scores primarily in the first months of treatment: mean ± SE change from baseline -0.66 ± 0.12, -0.44 ± 0.12, and -0.42 ± 0.13 at 6, 12, and 18 months, respectively (all P < .01). No other PRO worsening was associated with 25 mg OCA. Patients experiencing fibrosis improvement, Nonalcoholic Fatty Liver Disease Activity Score decrease (by ≥2 points), or NASH resolution had greater PRO improvements in some domains.
CONCLUSIONS


NASH patients evaluated in REGENERATE had impaired quality of life and underlying pruritus at baseline. Improvement of NASH corresponded with improvement in several HRQoL domains. Generally mild pruritus occurs early after OCA therapy initiation and does not worsen over time. ClinicalTrials.gov: NCT02548351.",2021,Nineteen (1.6%) patients discontinued therapy (protocol mandated) due to grade 3 pruritus.,"['patients with NASH', '1,218 patients (age, 54.1±11.5 years; 57% female; 43% F3) in the expanded ITT population (F1-F3', 'Patients With Nonalcoholic Steatohepatitis', 'Noncirrhotic NASH patients in a phase 3']","['obeticholic acid (OCA', 'Nonalcoholic steatohepatitis (NASH', 'OCA', 'Obeticholic Acid', 'NASH', 'placebo', 'OCA or placebo']","['Chronic Liver Disease Questionnaire-NASH (CLDQ-NASH) and EuroQol EQ-5D-5L (EQ-5D', 'PRO worsening', 'mild worsening of itch scores', 'quality of life and underlying pruritus', 'PRO improvements', 'Quality of Life', 'Nonalcoholic Fatty Liver Disease Activity Score decrease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",1218.0,0.261628,Nineteen (1.6%) patients discontinued therapy (protocol mandated) due to grade 3 pruritus.,"[{'ForeName': 'Zobair M', 'Initials': 'ZM', 'LastName': 'Younossi', 'Affiliation': 'Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia; Center for Liver Diseases, Department of Medicine, Inova Fairfax Medical Campus, Falls Church, Virginia. Electronic address: zobair.younossi@inova.org.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Stepanova', 'Affiliation': 'Center for Outcomes Research in Liver Disease, Washington, District of Columbia.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Nader', 'Affiliation': 'Center for Outcomes Research in Liver Disease, Washington, District of Columbia.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'University of California, San Diego, San Diego, California.'}, {'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; Newcastle National Institute for Health Research Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': 'Sorbonne Université, Institute of Cardiometabolism and Nutrition, Hôpital Pitié-Salpêtrière, INSERM UMRS 1138 CRC, Paris, France.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Clinical Research Center, San Antonio, Texas.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Jörn M', 'Initials': 'JM', 'LastName': 'Schattenberg', 'Affiliation': 'Department of Medicine, University Medical Center, Mainz, Germany.'}, {'ForeName': 'A Sidney', 'Initials': 'AS', 'LastName': 'Barritt', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Noureddin', 'Affiliation': 'Cedars-Sinai Medical Centre, Los Angeles, California.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bonacci', 'Affiliation': 'Intercept Pharmaceuticals, New York, New York.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Cawkwell', 'Affiliation': 'Intercept Pharmaceuticals, New York, New York.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'Intercept Pharmaceuticals, New York, New York.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rinella', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2021.07.020']
912,34274495,"Effect of healthy diet and exercise on chemotherapy completion rate in women with breast cancer: The Lifestyle, Exercise and Nutrition Early after Diagnosis (LEANer) study: Study protocol for a randomized clinical trial.","BACKGROUND


The World Cancer Research Fund and the American Cancer Society provide nutrition and physical activity guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines and delay efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse treatment-related side effects and may improve adherence to treatment, resulting in improved breast cancer prognosis. The Lifestyle, Exercise, and Nutrition Early after Diagnosis (LEANer) study is testing the effect of a nutrition and physical activity intervention on chemotherapy completion rates.
METHODS


172 women with stage I-III breast cancer undergoing chemotherapy will be randomized 1:1 to a yearlong, 16 session, nutrition and exercise intervention or usual care control group. The intervention is delivered by registered dietitians specializing in oncology nutrition and exercise training. The intervention includes goal setting to meet nutrition and physical activity guidelines for cancer survivors. After each chemotherapy session, date and dose of each drug administered, and reason for dose-adjustments and/or dose-delays are abstracted from the electronic medical record or obtained from the treating oncologist. Chemotherapy completion rate is assessed as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. Secondary endpoints of endocrine therapy adherence, treatment-related side effects, and changes in inflammatory and metabolic biomarkers, body composition, and patient reported outcomes are assessed at four timepoints.
DISCUSSION


If successful, this study has the potential to make healthy lifestyle interventions a standard component of breast cancer treatment.",2021,"Secondary endpoints of endocrine therapy adherence, treatment-related side effects, and changes in inflammatory and metabolic biomarkers, body composition, and patient reported outcomes are assessed at four timepoints.
","['women with breast cancer', '172 women with stage I-III breast cancer undergoing', 'cancer survivors', 'Many women with breast cancer']","['nutrition and physical activity intervention', 'healthy diet and exercise', 'oncology nutrition and exercise training', 'chemotherapy', 'nutrition and exercise intervention or usual care control group']","['chemotherapy completion rate', 'endocrine therapy adherence, treatment-related side effects, and changes in inflammatory and metabolic biomarkers, body composition', 'Chemotherapy completion rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",172.0,0.033828,"Secondary endpoints of endocrine therapy adherence, treatment-related side effects, and changes in inflammatory and metabolic biomarkers, body composition, and patient reported outcomes are assessed at four timepoints.
","[{'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sanft', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America; Yale Cancer Center, New Haven, CT, United States of America. Electronic address: tara.sanft@yale.edu.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Harrigan', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, United States of America. Electronic address: maura.harrigan@yale.edu.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, United States of America; Yale Cancer Center, New Haven, CT, United States of America. Electronic address: brenda.cartmel@yale.edu.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ferrucci', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, United States of America; Yale Cancer Center, New Haven, CT, United States of America. Electronic address: leah.ferrucci@yale.edu.'}, {'ForeName': 'Fang-Yong', 'Initials': 'FY', 'LastName': 'Li', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, United States of America. Electronic address: fang-yong.li@yale.edu.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'McGowan', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, United States of America. Electronic address: courtney.mcgowan@yale.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Zupa', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, United States of America. Electronic address: michelle.zupa@yale.edu.'}, {'ForeName': 'Thai Hien', 'Initials': 'TH', 'LastName': 'Nguyen', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, United States of America. Electronic address: thaihien.nguyen@yale.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ligibel', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, United States of America. Electronic address: ligibel@dfci.harvard.edu.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America. Electronic address: mneuhous@fredhutch.org.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America. Electronic address: dlh23@cumc.columbia.edu.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basen-Engquist', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America. Electronic address: kbasenen@mdanderson.org.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, United States of America; Yale Cancer Center, New Haven, CT, United States of America. Electronic address: beth.jones@yale.edu.'}, {'ForeName': 'Tish', 'Initials': 'T', 'LastName': 'Knobf', 'Affiliation': 'Yale Cancer Center, New Haven, CT, United States of America; Yale School of Nursing, New Haven, CT, United States of America. Electronic address: tish.knobf@yale.edu.'}, {'ForeName': 'Anees', 'Initials': 'A', 'LastName': 'Chagpar', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America; Yale Cancer Center, New Haven, CT, United States of America. Electronic address: anees.chagpar@yale.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Silber', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America; Yale Cancer Center, New Haven, CT, United States of America. Electronic address: andrea.silber@yale.edu.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, United States of America; Yale Cancer Center, New Haven, CT, United States of America. Electronic address: melinda.irwin@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106508']
913,34281958,High Oxalate Concentrations Correlate with Increased Risk for Sudden Cardiac Death in Dialysis Patients.,"BACKGROUND


The clinical significance of accumulating toxic terminal metabolites such as oxalate in patients with kidney failure is not well understood.
METHODS


To evaluate serum oxalate concentrations and risk of all-cause mortality and cardiovascular events in a cohort of patients with kidney failure requiring chronic dialysis, we performed a  post-hoc  analysis of the randomized German Diabetes Dialysis (4D) Study; this study included 1255 European patients on hemodialysis with diabetes followed-up for a median of 4 years. The results obtained  via  Cox proportional hazards models were confirmed by competing risk regression and restricted cubic spline modeling in the 4D Study cohort and validated in a separate cohort of 104 US patients on dialysis after a median follow-up of 2.5 years.
RESULTS


A total of 1108 patients had baseline oxalate measurements, with a median oxalate concentration of 42.4 µM. During follow-up, 548 patients died, including 139 (25.4%) from sudden cardiac death. A total of 413 patients reached the primary composite cardiovascular end point (cardiac death, nonfatal myocardial infarction, and fatal or nonfatal stroke). Patients in the highest oxalate quartile (≥59.7 µM) had a 40% increased risk for cardiovascular events (adjusted hazard ratio [aHR], 1.40; 95% confidence interval [95% CI], 1.08 to 1.81) and a 62% increased risk of sudden cardiac death (aHR, 1.62; 95% CI, 1.03 to 2.56), compared with those in the lowest quartile (≤29.6 µM). The associations remained when accounting for competing risks and with oxalate as a continuous variable.
CONCLUSIONS


Elevated serum oxalate is a novel risk factor for cardiovascular events and sudden cardiac death in patients on dialysis. Further studies are warranted to test whether oxalate-lowering strategies improve cardiovascular mortality in patients on dialysis.",2021,"Patients in the highest oxalate quartile (≥59.7 µM) had a 40% increased risk for cardiovascular events (adjusted hazard ratio [aHR], 1.40; 95% confidence interval [95% CI], 1.08 to 1.81) and a 62% increased risk of sudden cardiac death (aHR, 1.62; 95% CI, 1.03 to 2.56), compared with those in the lowest quartile (≤29.6 µM).","['1255 European hemodialysis patients with diabetes followed up for a median of 4 years', 'dialysis patients', '413 patients', 'kidney failure patients requiring chronic dialysis', 'Dialysis Patients', 'kidney failure patients', '1108 patients had baseline oxalate measurements, with a median oxalate concentration of 42.4 µM. During follow-up, 548 died, including 139 (25.4%) from sudden cardiac death']",[],"['risk for cardiovascular events', 'risk of sudden cardiac death', 'primary composite cardiovascular endpoint (cardiac death, nonfatal myocardial infarction, and fatal or nonfatal stroke', 'cardiovascular mortality']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0202153', 'cui_str': 'Oxalate measurement'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1255.0,0.128581,"Patients in the highest oxalate quartile (≥59.7 µM) had a 40% increased risk for cardiovascular events (adjusted hazard ratio [aHR], 1.40; 95% confidence interval [95% CI], 1.08 to 1.81) and a 62% increased risk of sudden cardiac death (aHR, 1.62; 95% CI, 1.03 to 2.56), compared with those in the lowest quartile (≤29.6 µM).","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pfau', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Ermer', 'Affiliation': 'Department of Nephrology and Hypertension, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Coca', 'Affiliation': 'Division of Nephrology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Maria Clarissa', 'Initials': 'MC', 'LastName': 'Tio', 'Affiliation': ""Division of Renal Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Genser', 'Affiliation': 'BGStats Consulting, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reichel', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Fredric O', 'Initials': 'FO', 'LastName': 'Finkelstein', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'März', 'Affiliation': 'Medical Clinic V (Nephrology, Hypertensiology, Rheumatology, Endocrinology, Diabetology), University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine 1 and Comprehensive Heart Failure Centre, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Sushrut S', 'Initials': 'SS', 'LastName': 'Waikar', 'Affiliation': 'Section of Nephrology, Department of Medicine, Boston University School of Medicine and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Kai-Uwe', 'Initials': 'KU', 'LastName': 'Eckardt', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Aronson', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Drechsler', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine 1 and Comprehensive Heart Failure Centre, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Knauf', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany Felix.Knauf@charite.de.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020121793']
914,34283851,A breakthrough series collaborative to increase patient participation with hemodialysis tasks: A stepped wedge cluster randomised controlled trial.,"BACKGROUND


Compared to in-centre, home hemodialysis is associated with superior outcomes. The impact on patient experience and clinical outcomes of consistently providing the choice and training to undertake hemodialysis-related treatment tasks in the in-centre setting is unknown.
METHODS


A stepped-wedge cluster randomised trial in 12 UK renal centres recruited prevalent in-centre hemodialysis patients with sites randomised into early and late participation in a 12-month breakthrough series collaborative that included data collection, learning events, Plan-Study-Do-Act cycles, and teleconferences repeated every 6 weeks, underpinned by a faculty, co-production, materials and a nursing course. The primary outcome was the proportion of patients undertaking five or more hemodialysis-related tasks or home hemodialysis. Secondary outcomes included independent hemodialysis, quality of life, symptoms, patient activation and hospitalisation. ISRCTN Registration Number 93999549.
RESULTS


586 hemodialysis patients were recruited. The proportion performing 5 or more tasks or home hemodialysis increased from 45.6% to 52.3% (205 to 244/449, difference 6.2%, 95% CI 1.4 to 11%), however after analysis by step the adjusted odds ratio for the intervention was 1.63 (95% CI 0.94 to 2.81, P = 0.08). 28.3% of patients doing less than 5 tasks at baseline performed 5 or more at the end of the study (69/244, 95% CI 22.2-34.3%, adjusted odds ratio 3.71, 95% CI 1.66-8.31). Independent or home hemodialysis increased from 7.5% to 11.6% (32 to 49/423, difference 4.0%, 95% CI 1.0-7.0), but the remaining secondary endpoints were unaffected.
CONCLUSIONS


Our intervention did not increase dialysis related tasks being performed by a prevalent population of centre based patients, but there was an increase in home hemodialysis as well as an increase in tasks among patients who were doing fewer than 5 at baseline. Further studies are required that examine interventions to engage people who dialyse at centres in their own care.",2021,"Independent or home hemodialysis increased from 7.5% to 11.6% (32 to 49/423, difference 4.0%, 95% CI 1.0-7.0), but the remaining secondary endpoints were unaffected.
","['12 UK renal centres recruited prevalent in-centre hemodialysis patients with sites randomised into early and late participation in a 12-month breakthrough series collaborative that included data collection, learning events, Plan-Study-Do-Act cycles, and teleconferences repeated every 6 weeks, underpinned by a faculty, co-production, materials and a nursing course', '586 hemodialysis patients were recruited', 'patient participation with hemodialysis tasks']",[],"['hemodialysis, quality of life, symptoms, patient activation and hospitalisation', 'proportion performing 5 or more tasks or home hemodialysis', 'proportion of patients undertaking five or more hemodialysis-related tasks or home hemodialysis']","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0585336', 'cui_str': 'Every six weeks'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0030699', 'cui_str': 'Client participation'}]",[],"[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019008', 'cui_str': 'Home Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",586.0,0.276643,"Independent or home hemodialysis increased from 7.5% to 11.6% (32 to 49/423, difference 4.0%, 95% CI 1.0-7.0), but the remaining secondary endpoints were unaffected.
","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fotheringham', 'Affiliation': 'Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Barnes', 'Affiliation': 'Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England.'}, {'ForeName': 'Louese', 'Initials': 'L', 'LastName': 'Dunn', 'Affiliation': 'Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ariss', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Young', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Walters', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Laboi', 'Affiliation': 'Renal Department, York Teaching Hospital NHS Foundation Trust, York, England.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Henwood', 'Affiliation': 'Renal Department, York Teaching Hospital NHS Foundation Trust, York, England.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Gair', 'Affiliation': 'Think Kidneys, UK Renal Registry, Bristol, England.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wilkie', 'Affiliation': 'Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England.'}]",PloS one,['10.1371/journal.pone.0253966']
915,34287900,Enhanced recovery after pancreatic surgery: A prospective randomized controlled clinical trial.,"BACKGROUND AND OBJECTIVES


The enhanced recovery after surgery (ERAS) protocol is a perioperative care bundle designed to achieve early healing after surgical procedures. This study aims to investigate the effect of the ERAS protocol on postoperative complications, length of hospital stay (LOS), and readmission rates in pancreatic surgery patients.
METHODS


The study was designed as a prospective and randomized controlled study between January 2016 and November 2018 on pancreatic surgery patients. A total of 38 patients were analyzed, 18 of whom were in the ERAS group and 20 in the control group. Patient demographics, intraoperative variables, and postoperative outcomes were recorded.
RESULTS


The groups were similar regarding age, sex, surgery type, American Society of Anesthesiologists scores, and laboratory results. There was no significant difference in the intraoperative variables. Early oral feeding was preferred, mostly in the ERAS group compared to the control group. Perioperative complication rates, including delayed gastric emptying and pancreatic fistula, LOS, and readmission rates, were similar between the two groups.
CONCLUSIONS


The ERAS protocol provided a minimal decrease in the total complication rates and had no effect on severe complications. Therefore, the ERAS protocol seems feasible and can be applied safely in pancreatic surgery patients.",2021,"Perioperative complication rates, including delayed gastric emptying and pancreatic fistula, LOS, and readmission rates, were similar between the two groups.
","['January 2016 and November 2018 on pancreatic surgery patients', 'A total of 38 patients were analyzed, 18 of whom were in the ERAS group and 20 in the control group', 'pancreatic surgery patients']",['ERAS protocol'],"['total complication rates', 'severe complications', 'intraoperative variables', 'postoperative complications, length of hospital stay (LOS), and readmission rates', 'Perioperative complication rates', 'delayed gastric emptying and pancreatic fistula, LOS, and readmission rates']","[{'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}]",38.0,0.050453,"Perioperative complication rates, including delayed gastric emptying and pancreatic fistula, LOS, and readmission rates, were similar between the two groups.
","[{'ForeName': 'Muhammer', 'Initials': 'M', 'LastName': 'Ergenc', 'Affiliation': 'Department of General Surgery, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Sakir', 'Initials': 'S', 'LastName': 'Karpuz', 'Affiliation': 'Department of General Surgery, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Ergenc', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Cumhur', 'Initials': 'C', 'LastName': 'Yegen', 'Affiliation': 'Department of General Surgery, School of Medicine, Marmara University, Istanbul, Turkey.'}]",Journal of surgical oncology,['10.1002/jso.26614']
916,34287817,Stimulation of the Social Brain Improves Perspective Selection in Older Adults: A HD-tDCS Study.,"There is evidence for dissociable, causal roles for two key social brain regions in young adults. Specifically, the right temporoparietal junction (rTPJ) is associated with embodied perspective taking, whereas the dorsomedial prefrontal cortex (dmPFC) is associated with the integration of social information. However, it is unknown whether these causal brain-behaviour associations are evident in older adults. Fifty-two healthy older adults were stratified to receive either rTPJ or dmPFC anodal high-definition transcranial direct current stimulation in a sham-controlled, double-blinded, repeated-measures design. Self-other processing was assessed across implicit and explicit level one (line-of-sight) and level two (embodied rotation) visual perspective taking (VPT) tasks, and self-other encoding effects on episodic memory. Both rTPJ and dmPFC stimulation reduced the influence of the alternate perspective during level one VPT, indexed by a reduced congruency effect (difference between congruent and incongruent perspectives). There were no stimulation effects on level two perspective taking nor self-other encoding effects on episodic memory. Stimulation to the rTPJ and dmPFC improved perspective selection during level one perspective taking. However, dissociable effects on self-other processing, previously observed in young adults, were not identified in older adults. The results provide causal evidence for age-related changes in social brain function that requires further scrutinization.",2021,"However, dissociable effects on self-other processing, previously observed in young adults, were not identified in older adults.","['Fifty-two healthy older adults', 'young adults', 'older adults', 'Older Adults']","['right temporoparietal junction (rTPJ', 'rTPJ and dmPFC', 'rTPJ or dmPFC anodal high-definition transcranial direct current stimulation', 'Social Brain']","['implicit and explicit level one (line-of-sight) and level two (embodied rotation) visual perspective taking (VPT) tasks, and self-other encoding\xa0effects on episodic memory', 'episodic memory']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}]",52.0,0.0896306,"However, dissociable effects on self-other processing, previously observed in young adults, were not identified in older adults.","[{'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Martin', 'Affiliation': 'UQ Centre for Clinical Research, The University of Queensland, St Lucia, Australia. a.martin-2440@kent.ac.uk.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Perceval', 'Affiliation': 'UQ Centre for Clinical Research, The University of Queensland, St Lucia, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roheger', 'Affiliation': 'Department of Neurology, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Davies', 'Affiliation': 'Queensland Brain Institute, University of Queensland, St Lucia, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Meinzer', 'Affiliation': 'UQ Centre for Clinical Research, The University of Queensland, St Lucia, Australia.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-021-00929-2']
917,34289739,First-in-Human Clinical Application of the Medyria TrackCath System in Endovascular Repair of Complex Aortic Aneurysms (ACCESS Trial): A Prospective Multicenter Single-Arm Clinical Trial.,"PURPOSE


The Medyria TrackCath Catheter (MedTCC) is an innovative, thermal convection-based blood flow velocity (BFV) tracking catheter that may be used during complex aortic endovascular procedures for identification and catheterization of target orifices. The ACCESS Trial analyzes the safety and performance of the MedTCC for targeted vessel catheterization to generally evaluate the feasibility of thermal convection-based BFV.
MATERIALS AND METHODS


We performed a first-in-human, proof-of-concept, prospective single-arm multicenter clinical trial between March 2018 and February 2019 in patients who underwent endovascular aortic procedures at 4 high-volume centers. During these procedures, the MedTCC was advanced over a guidewire through the femoral access. The D-shape was enfolded in the reno-visceral part of the aorta and target orifices were identified and catheterized with a guidewire via the side port of the MedTCC through BFV tracking. BFV measurements were performed at baseline (Baseline-BFV), alignment to the orifice (Orifice-BFV), and following catheterization (Confirmation-BFV) to prove correct identification and catheterization of target orifices. The procedural success rate, the catheterization success rate, procedure-related parameters, and (serious) adverse events ((S)AE) during the follow-up were analyzed.
RESULTS


A total of 38 patients were included in the safety group (SG) and 26 in the performance group (PG). The procedural success rate was 89% (PG), the MedTCC catheterization success rate was 98% (PG). The MedTCC reliably measured BFV changes indicated by significant differences in BFV between Baseline-BFV and Orifice-BFV (p<0.05). Median (interquartile range; IQR) fluoroscopy time per orifice was 5.0 (1.5-8.5) minutes [total surgery 49 (26-74) minutes], median (IQR) contrast agent used per orifice was 1.0 (0-5.0) mL [total surgery 80 (40-100) mL], and median (IQR) MedTCC-based procedural time was 3.0 (2.0-6.0) minutes. There was no device-related SAE.
CONCLUSIONS


The ACCESS Trial suggests that BFV measurement allows for reliable target orifice identification and catheterization. The use of MedTCC is safe and generates short fluoroscopy time and low contrast agent use, which in turn might facilitate complex endovascular procedures.",2021,"The procedural success rate was 89% (PG), the MedTCC catheterization success rate was 98% (PG).","['38 patients were included in the safety group (SG) and 26 in the performance group (PG', 'We performed a first-in-human, proof-of-concept, prospective single-arm multicenter clinical trial between March 2018 and February 2019 in patients who underwent endovascular aortic procedures at 4 high-volume centers']","['Medyria TrackCath System', 'MedTCC', 'Medyria TrackCath Catheter (MedTCC']","['median (IQR) MedTCC-based procedural time', 'procedural success rate, the catheterization success rate, procedure-related parameters, and (serious) adverse events ((S)AE', 'MedTCC catheterization success rate', 'Median (interquartile range; IQR) fluoroscopy time per orifice', 'BFV', 'median (IQR) contrast agent used per orifice', 'procedural success rate', 'BFV measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0556981', 'cui_str': '% proof'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",38.0,0.0545643,"The procedural success rate was 89% (PG), the MedTCC catheterization success rate was 98% (PG).","[{'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Floros', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kölbel', 'Affiliation': 'German Aortic Center, Department of Vascular Medicine, University Heart & Vascular Center, Hamburg, Germany.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Tsilimparis', 'Affiliation': 'German Aortic Center, Department of Vascular Medicine, University Heart & Vascular Center, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Oberhuber', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kindl', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kalder', 'Affiliation': 'Department of Vascular Surgery, University Hospital RWTH Aachen, European Vascular Center Aachen-Maastricht, Aachen, Germany.'}, {'ForeName': 'Drosos', 'Initials': 'D', 'LastName': 'Kotelis', 'Affiliation': 'Department of Vascular Surgery, University Hospital RWTH Aachen, European Vascular Center Aachen-Maastricht, Aachen, Germany.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Clinic and Policlinic V, Angiology, University Hospital Leipzig, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Branzan', 'Affiliation': 'Department of Vascular Surgery, University Hospital Leipzig, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Adolf', 'Affiliation': 'StatConsult GmbH, Magdeburg, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Schelzig', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany.'}, {'ForeName': 'Markus Udo', 'Initials': 'MU', 'LastName': 'Wagenhäuser', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/15266028211030536']
918,34303017,Response to Omalizumab in Black and White Patients with Allergic Asthma.,"BACKGROUND


Higher asthma burden is more likely to be experienced by Black than White patients. In clinical research, underrepresentation of minority populations is observed.
OBJECTIVE


To estimate response to omalizumab in Black and White patients in North America with moderate to severe asthma.
METHODS


Data from placebo-controlled (EXTRA) and single-armed (PROSPERO) omalizumab studies were used for this post hoc analysis. We used a Poisson regression model to examine exacerbation rates. An analysis of covariance model was used to estimate placebo-corrected change in FEV 1  and Asthma Quality of Life Questionnaire (AQLQ) by racial group.
RESULTS


This analysis included 631 White and 176 Black patients from EXTRA and 567 White and 130 Black patients from PROSPERO. In EXTRA, placebo-corrected exacerbation rate reductions (relative rate change [95% confidence interval], 22.6% [2.0-38.9%] vs 22.0% [-18.0% to 48.4%]) and FEV 1  improvements were similar for White and Black patients. There was a trend toward greater AQLQ improvements for Black versus White patients (least squares mean treatment differences: 0.0 vs 0.3, 0.6 vs 0.4, and 0.6 vs 0.2 at weeks 16, 32, and 48, respectively) throughout the study. In PROSPERO, on-study exacerbation rates (0.76 [0.65-0.88] vs 0.77 [0.56-1.10]) and AQLQ improvements (least squares mean change from baseline: 1.2 vs 1.2 and 1.3 vs 1.2 at month 6 and end of study, respectively) were similar for White versus Black patients. A trend toward greater FEV 1  improvement was observed in White versus Black patients throughout the study.
CONCLUSIONS


This analysis of EXTRA and PROSPERO suggests that Black and White patients with moderate to severe asthma experience similar improvements in exacerbations, FEV 1 , and AQLQ with omalizumab.",2021,"In EXTRA, placebo-corrected exacerbation rate reductions (relative rate change [95% CI], 22.6% [2.0-38.9%] vs 22.0% [-18.0%, 48.4%]) and FEV 1  improvements were similar for White and Black patients.","['631 White/176 Black patients from EXTRA and 567 White/130 Black patients from PROSPERO', 'Black and White patients in North America with moderate-to-severe asthma', 'Black and White Patients with Allergic Asthma']","['Omalizumab', 'placebo-controlled', 'omalizumab']","['AQLQ improvements (LSM change', 'FEV 1  and Asthma Quality of Life Questionnaire (AQLQ', 'exacerbation rates', 'AQLQ improvements', 'exacerbation rate reductions']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",631.0,0.263109,"In EXTRA, placebo-corrected exacerbation rate reductions (relative rate change [95% CI], 22.6% [2.0-38.9%] vs 22.0% [-18.0%, 48.4%]) and FEV 1  improvements were similar for White and Black patients.","[{'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Pediatric Asthma Research Program, Breathing Institute, Children's Hospital Colorado, and University of Colorado School of Medicine, Aurora, Colo.""}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Jerschow', 'Affiliation': 'Department of Microbiology & Immunology, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Bongin', 'Initials': 'B', 'LastName': 'Yoo', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Pranathi', 'Initials': 'P', 'LastName': 'Janampally', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Pazwash', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Cecile T J', 'Initials': 'CTJ', 'LastName': 'Holweg', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif. Electronic address: holweg.cecile@gene.com.'}, {'ForeName': 'Golda', 'Initials': 'G', 'LastName': 'Hudes', 'Affiliation': 'Department of Microbiology & Immunology, Albert Einstein College of Medicine, Bronx, NY.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2021.07.013']
919,34304913,Efficacy of a Fixed-Dose Combination of Ibuprofen and Acetaminophen Compared With Individual Monocomponents in Adult Male Subjects With Endotoxin-Induced Fever: A Randomized Controlled Trial.,"PURPOSE


This study evaluated antipyretic efficacy and onset of a novel fixed-dose combination (FDC) of ibuprofen (IBU; 250 mg) and acetaminophen (APAP; 500 mg) compared with placebo and IBU or APAP monocomponents. MET: This single-center, randomized, double-blind, placebo-controlled, full-factorial study was conducted in healthy males aged 18 to 55 years with pyrexia induced by intravenous administration of reference standard endotoxin (RSE). After attainment of an oral temperature ≥38.1°C, subjects were randomized 3:3:3:1 to a double-blind single oral dose of FDC IBU/APAP 250 mg/500 mg, APAP 500 mg, IBU 250 mg, or placebo. Oral temperature was measured every 10 minutes for 2 hours, then every 30 minutes until 8 hours postdose. Time-weighted sum of temperature differences from baseline to 8 hours (WSTD 0-8 ) after study medication administration was the primary efficacy end point. Secondary end points included WSTD scores from 0 to 2 hours, 0 to 4 hours, 0 to 6 hours, and 6 to 8 hours; time to return to ""normal"" temperature; time to rescue medication use; and global drug evaluation. Safety was assessed via adverse events (AEs).
FINDINGS


Two hundred ninety subjects were randomized; 273 were included in the primary efficacy analysis. WSTD 0-8  was significantly better for FDC IBU/APAP 250 mg/500 mg (P = 0.002), IBU 250 mg (P = 0.030), and APAP 500 mg (P = 0.023) versus placebo; there were no significant differences between active treatments. For WSTD 0-2 , only the FDC was statistically significant versus placebo (P = 0.004). All active treatments were significantly better (P < 0.05) for WSTD 0-4  and WSTD 0-6  versus placebo; there were no differences in WSTD 6-8  between cohorts. Temperature returned to normal during the 8-hour treatment period in ∼50% of subjects in each cohort. Only 1 subject (IBU cohort) took rescue medication. Post hoc analyses at early time points revealed significant treatment differences favoring FDC versus placebo and IBU for the WSTD from baseline during the 50- to 110-minute posttreatment window; for WSTD from baseline during the 80- to 110-minute posttreatment window, FDC provided significant treatment differences versus placebo and both monocomponents. Overall, 223 (76.9%) of 290 subjects experienced AEs related to RSE; only 2 subjects experienced treatment-related AEs (FDC, rash; placebo, ear pain).
IMPLICATIONS


Although the primary end point was not met, these results suggest that FDC IBU/APAP 250 mg/500 mg provides effective antipyresis with a faster onset versus equal doses of IBU and APAP alone. ClinicalTrials.gov identifier: NCT02761980.",2021,"Post hoc analyses at early time points revealed significant treatment differences favoring FDC versus placebo and IBU for the WSTD from baseline during the 50- to 110-minute posttreatment window; for WSTD from baseline during the 80- to 110-minute posttreatment window, FDC provided significant treatment differences versus placebo and both monocomponents.","['healthy males aged 18 to 55 years with pyrexia induced by intravenous administration of', 'MET', 'Two hundred ninety subjects were randomized; 273', 'Adult Male Subjects With Endotoxin-Induced Fever', '290 subjects']","['reference standard endotoxin (RSE', 'FDC IBU/APAP', 'Ibuprofen and Acetaminophen', 'placebo', 'Individual Monocomponents', '2021;43:XXX-XXX', 'acetaminophen (APAP', 'FDC IBU/APAP 250 mg/500 mg, APAP 500 mg, IBU 250 mg, or placebo', 'placebo and IBU or APAP monocomponents', 'novel fixed-dose combination (FDC) of ibuprofen (IBU']","['Oral temperature', 'Temperature', 'antipyretic efficacy', 'treatment-related AEs (FDC, rash; placebo, ear pain', 'WSTD scores from 0 to 2 hours, 0 to 4 hours, 0 to 6 hours, and 6 to 8 hours; time to return to ""normal"" temperature; time to rescue medication use; and global drug evaluation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C5191218', 'cui_str': '290'}]","[{'cui': 'C0034925', 'cui_str': 'Standards, Reference'}, {'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3653108', 'cui_str': 'ibuprofen, combinations'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C1532216', 'cui_str': 'Oral temperature'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]",290.0,0.280146,"Post hoc analyses at early time points revealed significant treatment differences favoring FDC versus placebo and IBU for the WSTD from baseline during the 50- to 110-minute posttreatment window; for WSTD from baseline during the 80- to 110-minute posttreatment window, FDC provided significant treatment differences versus placebo and both monocomponents.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Smith', 'Affiliation': 'Alliance for Multispecialty Research, The University of Tennessee Medical Center, Knoxville, Tennessee. Electronic address: william.smith@amrllc.com.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Leyva', 'Affiliation': 'GSK Consumer Healthcare, Madison, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kellstein', 'Affiliation': 'Pfizer Consumer Healthcare, Madison, New Jersey.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Arthur', 'Affiliation': 'Pfizer Inc, Peapack, New Jersey.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cruz-Rivera', 'Affiliation': 'Pfizer Consumer Healthcare, Madison, New Jersey.'}]",Clinical therapeutics,['10.1016/j.clinthera.2021.05.004']
920,34303491,Effect of Hypotension Prediction Index-guided intraoperative haemodynamic care on depth and duration of postoperative hypotension: a sub-study of the Hypotension Prediction trial.,"BACKGROUND


Intraoperative and postoperative hypotension are associated with morbidity and mortality. The Hypotension Prediction (HYPE) trial showed that the Hypotension Prediction Index (HPI) reduced the depth and duration of intraoperative hypotension (IOH), without excess use of intravenous fluid, vasopressor, and/or inotropic therapies. We hypothesised that intraoperative HPI-guided haemodynamic care would reduce the severity of postoperative hypotension in the PACU.
METHODS


This was a sub-study of the HYPE study, in which 60 adults undergoing elective noncardiac surgery were allocated randomly to intraoperative HPI-guided or standard haemodynamic care. Blood pressure was measured using a radial intra-arterial catheter, which was connected to a FloTracIQ sensor. Hypotension was defined as MAP <65 mm Hg, and a hypotensive event was defined as MAP <65 mm Hg for at least 1 min. The primary outcome was the time-weighted average (TWA) of postoperative hypotension. Secondary outcomes were absolute incidence, area under threshold for hypotension, and percentage of time spent with MAP <65 mm Hg.
RESULTS


Overall, 54/60 (90%) subjects (age 64 (8) yr; 44% female) completed the protocol, owing to failure of the FloTracIQ device in 6/60 (10%) patients. Intraoperative HPI-guided care was used in 28 subjects; 26 subjects were randomised to the control group. Postoperative hypotension occurred in 37/54 (68%) subjects. HPI-guided care did not reduce the median duration (TWA) of postoperative hypotension (adjusted median difference, vs standard of care: 0.118; 95% confidence interval [CI], 0-0.332; P=0.112). HPI-guidance reduced the percentage of time with MAP <65 mm Hg by 4.9% (adjusted median difference: -4.9; 95% CI, -11.7 to -0.01; P=0.046).
CONCLUSIONS


Intraoperative HPI-guided haemodynamic care did not reduce the TWA of postoperative hypotension.",2021,"HPI-guided care did not reduce the median duration (TWA) of postoperative hypotension (adjusted median difference, vs standard of care: 0.118; 95% confidence interval [CI], 0-0.332; P=0.112).","['Overall, 54/60 (90%) subjects (age 64 (8) yr; 44% female) completed the protocol, owing to failure of the FloTracIQ device in 6/60 (10%) patients', '28 subjects; 26 subjects', '60 adults undergoing elective noncardiac surgery']","['Intraoperative HPI-guided care', 'Hypotension Prediction Index-guided intraoperative haemodynamic care', 'intraoperative HPI-guided or standard haemodynamic care']","['percentage of time with MAP', 'depth and duration of postoperative hypotension', 'absolute incidence, area under threshold for hypotension, and percentage of time spent with MAP <65 mm Hg', 'Hypotension', 'TWA of postoperative hypotension', 'Blood pressure', 'Hypotension Prediction Index (HPI) reduced the depth and duration of intraoperative hypotension (IOH', 'time-weighted average (TWA) of postoperative hypotension', 'Postoperative hypotension', 'hypotensive event', 'median duration (TWA) of postoperative hypotension']","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0442756', 'cui_str': 'Distance vision 6/60'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C3251803', 'cui_str': 'Hemodynamic care'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0865752', 'cui_str': 'Postoperative hypotension'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",60.0,0.496619,"HPI-guided care did not reduce the median duration (TWA) of postoperative hypotension (adjusted median difference, vs standard of care: 0.118; 95% confidence interval [CI], 0-0.332; P=0.112).","[{'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Schenk', 'Affiliation': 'Department of Anaesthesiology, Amsterdam UMC, Location Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Wijnberge', 'Affiliation': 'Department of Anaesthesiology, Amsterdam UMC, Location Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Jolanda M', 'Initials': 'JM', 'LastName': 'Maaskant', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, Location Academic Medical Centre and University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anaesthesiology, Amsterdam UMC, Location Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'Hol', 'Affiliation': 'Department of Anaesthesiology, Amsterdam UMC, Location Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Rogier V', 'Initials': 'RV', 'LastName': 'Immink', 'Affiliation': 'Department of Anaesthesiology, Amsterdam UMC, Location Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Vlaar', 'Affiliation': 'Department of Intensive Care, Amsterdam UMC, Location Academic Medical Centre, Amsterdam, the Netherlands. Electronic address: a.p.vlaar@amsterdamumc.nl.'}, {'ForeName': 'Björn J P', 'Initials': 'BJP', 'LastName': 'van der Ster', 'Affiliation': 'Department of Anaesthesiology, Amsterdam UMC, Location Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart F', 'Initials': 'BF', 'LastName': 'Geerts', 'Affiliation': 'Department of Anaesthesiology, Amsterdam UMC, Location Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Denise P', 'Initials': 'DP', 'LastName': 'Veelo', 'Affiliation': 'Department of Anaesthesiology, Amsterdam UMC, Location Academic Medical Centre, Amsterdam, the Netherlands.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.05.033']
921,34311004,Impact of radiotherapy protocol adherence in NSCLC patients treated with concurrent chemoradiation: RTQA results of the PET-Plan trial.,"INTRODUCTION


The success of intensification and personalisation of the curative treatment of non-small cell lung cancer (NSCLC) is strongly associated with the precision in radiotherapy. Here, we evaluate the impact of radiotherapy protocol adherence in a prospective multicentre trial.
METHODS


In the open-label, randomised, controlled PET-Plan trial, patients with inoperable NSCLC were randomized at a 1:1 ratio regarding the target volume delineation informed by  1 F-FDG PET and CT plus elective nodal irradiation (arm A) or target volumes informed by PET alone (arm B) and received iso-toxically dose-escalated concurrent chemoradiation. The prospectively organised quality assurance program (RTQA) included individual case review by predefined criteria. For evaluation, protocol adherence was scored as per protocol (pP), with minor (miD), intermediate (inD) and major (maD) deviations. In order to exclude biases through patients who discontinued treatment, patients who received ≥60 Gy were additionally analysed.
RESULTS


Between 05/2009-11/2016, 205 patients were randomized, 204 patients started treatment according to protocol of which 31 (15%) patients had maD. Patients with maD had an inferior overall survival (OS) (HR 2.9, 95% CI 1.8-4.4, p < 0.0001) and a higher risk of loco-regional progression (HR 5.7, 95% CI 2.7-11.1, p < 0.0001). These results were significant also in the subgroup of patients receiving ≥ 60 Gy. Patients with maD concerning normal tissue delineation and/or dose constraints had a worse OS (p = 0.006) although no higher incidence of grade ≥ 3 toxicities.
CONCLUSIONS


Non-adherence to the radiotherapy protocol was associated with an inferior OS and loco-regional control. These results underline the importance of RTQA.",2021,"Patients with maD concerning normal tissue delineation and/or dose constraints had a worse OS (p=0.006) although no higher incidence of grade ≥ 3 toxicities.
","['patients with locally advanced NSCLC treated with concurrent chemoradiation', 'patients with inoperable NSCLC', 'non-small cell lung cancer (NSCLC', 'Between 05/2009 -11/2016']","['radiotherapy protocol adherence', 'FDG PET and CT plus elective nodal irradiation (arm A) or target volumes informed by PET alone (arm B) and received iso-toxically dose-escalated concurrent chemoradiation']","['higher risk of loco-regional progression', 'inferior overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",205.0,0.0974424,"Patients with maD concerning normal tissue delineation and/or dose constraints had a worse OS (p=0.006) although no higher incidence of grade ≥ 3 toxicities.
","[{'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Gkika', 'Affiliation': 'Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine, University of Freiburg, Germany. Electronic address: eleni.gkika@uniklinik-freiburg.de.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Schimek-Jasch', 'Affiliation': 'Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kremp', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lenz', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Stockinger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Mainz, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaefer-Schuler', 'Affiliation': 'Department of Nuclear Medicine, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mix', 'Affiliation': 'Faculty of Medicine, University of Freiburg, Germany; Department of Nuclear Medicine, Medical Center, University of Freiburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Küsters', 'Affiliation': 'Department of Radiation Oncology, Kliniken Maria Hilf, Mönchengladbach, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tosch', 'Affiliation': 'Department of Nuclear Medicine, Helios University Hospital Wuppertal, Germany; Department of Medicine, Faculty of Health, University of Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hehr', 'Affiliation': 'Department of Radiation Oncology, Marienhospital, Stuttgart, Germany.'}, {'ForeName': 'Susanne Martina', 'Initials': 'SM', 'LastName': 'Eschmann', 'Affiliation': 'Department of Nuclear Medicine, Marienhospital, Stuttgart, Germany.'}, {'ForeName': 'Yves-Pierre', 'Initials': 'YP', 'LastName': 'Bultel', 'Affiliation': 'Department of Radiation Oncology, Klinikum Mutterhaus der Boromäerinnen, Trier, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hass', 'Affiliation': 'Department of Radiation Oncology, University Hospital Magdeburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Fleckenstein', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Alexander Henry', 'Initials': 'AH', 'LastName': 'Thieme', 'Affiliation': 'Department of Radiation Oncology, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Dieckmann', 'Affiliation': 'Department of Radiotherapy, Vienna General Hospital, Medical University of Vienna, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Miederer', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Mainz, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Holl', 'Affiliation': 'Department of Nuclear Medicine, Helios Kliniken Schwerin, Germany.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Rischke', 'Affiliation': 'Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; Faculty of Medicine, University of Freiburg, Germany; Department of Nuclear Medicine, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Adebahr', 'Affiliation': 'Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Hospital of Mainz, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Binder', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Germany.'}, {'ForeName': 'Anca-Ligia', 'Initials': 'AL', 'LastName': 'Grosu', 'Affiliation': 'Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Nestle', 'Affiliation': 'Department of Radiation Oncology, Medical Center, University of Freiburg, Germany; German Cancer Consortium (DKTK) Partner Site Freiburg, German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine, University of Freiburg, Germany; Department of Nuclear Medicine, Medical Center, University of Freiburg, Germany.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.07.017']
922,34313917,Prophylactic Administration of Diphenhydramine/Acetaminophen and Ondansetron Reduced Postoperative Nausea and Vomiting and Pain Following Laparoscopic Sleeve Gastrectomy: a Randomized Controlled Trial.,"PURPOSE


Postoperative nausea and vomiting (PONV) and pain following bariatric surgery are problematic and affect the outcome of patients. Intraoperative multimodal antiemetic prophylaxis is essential to improve postoperative outcomes. This study investigated the effect of adding diphenhydramine to acetaminophen and ondansetron in reducing postoperative nausea and vomiting and pain following laparoscopic sleeve gastrectomy (LSG).
MATERIALS AND METHODS


Eighty-two patients scheduled for LSG were assigned to receive a single preinduction dose of diphenhydramine 0.4 mg/kg VI (D group) in addition to acetaminophen 1g and ondansetron 4 mg IV at the end of surgery and just acetaminophen 1 g and ondansetron 4 mg IV (C group) in a randomized, double-blind trial. PONV was assessed in recovery and 24 hours after surgery in the ward. Postoperative pain, analgesic requirements, and patients' level of sedation were also assessed.
RESULTS


The PONV rates in the recovery of the D group and the C group were 30% and 56% (P = .001). It also had a more significant reduction in the D group than in the C group in the first 24 h after surgery (40% vs. 66%). The severity of pain score and level of sedation and analgesic requirements was significantly reduced in this period in the D group.
CONCLUSION


Prophylactic diphenhydramine 0.4 mg/kg at the induction of general anesthesia in combination with acetaminophen 1 g and ondansetron 4 mg at the end of surgery reduced the incidence of PONV and postoperative severity of pain in laparoscopic sleeve gastrectomy.",2021,It also had a more significant reduction in the D group than in the C group in the first 24 h after surgery (40% vs. 66%).,['Eighty-two patients scheduled for LSG'],"['Prophylactic diphenhydramine', 'Diphenhydramine/Acetaminophen and Ondansetron', 'diphenhydramine 0.4 mg/kg VI (D group) in addition to acetaminophen 1g and ondansetron 4 mg IV at the end of surgery and just acetaminophen 1 g and ondansetron', 'laparoscopic sleeve gastrectomy (LSG', 'ondansetron', 'acetaminophen and ondansetron', 'Laparoscopic Sleeve Gastrectomy', 'diphenhydramine', 'laparoscopic sleeve gastrectomy', 'acetaminophen']","['Postoperative Nausea and Vomiting and Pain', 'incidence of PONV and postoperative severity of pain', ""Postoperative pain, analgesic requirements, and patients' level of sedation"", 'severity of pain score and level of sedation and analgesic requirements', 'PONV rates', 'PONV', 'Postoperative nausea and vomiting (PONV) and pain', 'postoperative nausea and vomiting and pain']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1123367', 'cui_str': 'Ondansetron 4 MG'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",82.0,0.671095,It also had a more significant reduction in the D group than in the C group in the first 24 h after surgery (40% vs. 66%).,"[{'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Pourfakhr', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Imam Khomeini St, Tehran, 11367-46911, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Aghabagheri', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Imam Khomeini St, Tehran, 11367-46911, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Zabihi Mahmoudabadi', 'Affiliation': 'Department of Surgery, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Khosrow', 'Initials': 'K', 'LastName': 'Najjari', 'Affiliation': 'Department of Surgery, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Talebpour', 'Affiliation': 'Department of Surgery, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khajavi', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Imam Khomeini St, Tehran, 11367-46911, Iran. khajavim@tums.ac.ir.'}]",Obesity surgery,['10.1007/s11695-021-05589-2']
923,34326476,"Errors in the implementation, analysis, and reporting of randomization within obesity and nutrition research: a guide to their avoidance.","Randomization is an important tool used to establish causal inferences in studies designed to further our understanding of questions related to obesity and nutrition. To take advantage of the inferences afforded by randomization, scientific standards must be upheld during the planning, execution, analysis, and reporting of such studies. We discuss ten errors in randomized experiments from real-world examples from the literature and outline best practices for their avoidance. These ten errors include: representing nonrandom allocation as random, failing to adequately conceal allocation, not accounting for changing allocation ratios, replacing subjects in nonrandom ways, failing to account for non-independence, drawing inferences by comparing statistical significance from within-group comparisons instead of between-groups, pooling data and breaking the randomized design, failing to account for missing data, failing to report sufficient information to understand study methods, and failing to frame the causal question as testing the randomized assignment per se. We hope that these examples will aid researchers, reviewers, journal editors, and other readers to endeavor to a high standard of scientific rigor in randomized experiments within obesity and nutrition research.",2021,"To take advantage of the inferences afforded by randomization, scientific standards must be upheld during the planning, execution, analysis, and reporting of such studies.",[],[],[],[],[],[],10.0,0.0653654,"To take advantage of the inferences afforded by randomization, scientific standards must be upheld during the planning, execution, analysis, and reporting of such studies.","[{'ForeName': 'Colby J', 'Initials': 'CJ', 'LastName': 'Vorland', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA. cvorland@iu.edu.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Brown', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Dawson', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Dickinson', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Golzarri-Arroyo', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Hannon', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Heymsfield', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Wasantha P', 'Initials': 'WP', 'LastName': 'Jayawardene', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'Chanaka N', 'Initials': 'CN', 'LastName': 'Kahathuduwa', 'Affiliation': 'Department of Psychiatry, School of Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Keith', 'Affiliation': 'Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Oakes', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Tekwe', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA. allison@iu.edu.'}]",International journal of obesity (2005),['10.1038/s41366-021-00909-z']
924,34325532,Comparison between acupuncture therapy and gabapentin for chronic pain: a pilot study.,"BACKGROUND


We examined whether the effect of true electroacupuncture on pain and functionality in chronic pain participants can be differentiated from that of medication (gabapentin) by analyzing quantitative sensory testing (QST).
METHODS


We recruited chronic back and neck pain participants who received six sessions (twice weekly) of true electroacupuncture versus sham electroacupuncture or 3 weeks of gabapentin versus placebo treatment. QST profiles, pain scores, and functionality profile were obtained at baseline (visit 1) and after three sessions (visit 4) or six sessions (visit 7) of acupuncture or 3 weeks of gabapentin or placebo.
RESULTS


A total of 50 participants were analyzed. We found no differences in QST profile changes (p = 0.892), pain reduction (p = 0.222), or functionality (p = 0.254) between the four groups. A major limitation of this pilot study was the limited number of study participants in each group.
CONCLUSION


This pilot study suggests that a large-scale clinical study with an adequate sample size would be warranted to compare acupuncture and medication therapy for chronic pain management.
TRIAL REGISTRATION NUMBER


NCT01678586 (ClinicalTrials.gov).",2021,"We found no differences in QST profile changes (p = 0.892), pain reduction (p = 0.222), or functionality (p = 0.254) between the four groups.","['chronic pain', 'A total of 50 participants were analyzed', 'chronic back and neck pain participants who received six sessions (twice weekly) of true', 'chronic pain participants']","['acupuncture', 'medication (gabapentin', 'acupuncture therapy and gabapentin', 'electroacupuncture', 'gabapentin or placebo', 'gabapentin versus placebo treatment', 'electroacupuncture versus sham electroacupuncture', 'acupuncture and medication therapy']","['QST profiles, pain scores, and functionality profile', 'pain and functionality', 'pain reduction', 'QST profile changes']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0205238', 'cui_str': 'True'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",50.0,0.553949,"We found no differences in QST profile changes (p = 0.892), pain reduction (p = 0.222), or functionality (p = 0.254) between the four groups.","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Houle', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Shihab', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Arissa', 'Initials': 'A', 'LastName': 'Opalacz', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Roth', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Evgenia Jen', 'Initials': 'EJ', 'LastName': 'Filatava', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Stabach', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Vo', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Malarick', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hyangin', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Zerong', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Shiqian', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jianren', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'MGH Center for Translational Pain Research, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/09645284211026683']
925,34325019,Impact of Early Cholecystectomy on the Cost of Treating Mild Gallstone Pancreatitis: Gallstone PANC Trial.,"BACKGROUND


The Gallstone Pancreatitis: Admission vs Normal Cholecystectomy (Gallstone PANC) Trial demonstrated that cholecystectomy within 24 hours of admission (early) compared with after clinical resolution (control) for mild gallstone pancreatitis, significantly reduced 30-day length-of-stay (LOS) without increasing major postoperative complications. We assessed whether early cholecystectomy decreased 90-day healthcare use and costs.
STUDY DESIGN


A secondary economic evaluation of the Gallstone PANC Trial was performed from the healthcare system perspective. Costs for index admissions and all gallstone pancreatitis-related care 90 days post-discharge were obtained from the hospital accounting system and inflated to 2020 USD. Negative binomial regression models and generalized linear models with log-link and gamma distribution, adjusting for randomization strata, were used. Bayesian analysis with neutral prior was used to estimate the probability of cost reduction with early cholecystectomy.
RESULTS


Of 98 randomized patients, 97 were included in the analyses. Baseline characteristics were similar in early (n = 49) and control (n = 48) groups. Early cholecystectomy resulted in a mean absolute difference in LOS of -0.96 days (95% CI, -1.91 to 0.00, p = 0.05). Ninety-day mean total costs were $14,974 (early) vs $16,190 (control) (cost ratio [CR], 0.92; 95% CI, 0.73-1.15, p = 0.47), with a mean absolute difference of $1,216 less (95% CI, -$4,782 to $2,349, p = 0.50) per patient in the early group. On Bayesian analysis, there was an 81% posterior probability that early cholecystectomy reduced 90-day total costs.
CONCLUSION


In this single-center trial, early cholecystectomy for mild gallstone pancreatitis reduced 90-day LOS and had an 81% probability of reducing 90-day healthcare system costs.",2021,"Ninety-day mean total costs were $14,974 (early) versus $16,190 (control) (cost ratio [CR], 0.92; 95% CI, 0.73-1.15, p=0.47) with mean absolute difference of $1,216 less (95% CI, -$4,782 to $2,349, p = 0.50) per patient in the early group.",['98 randomized patients'],"['Early Cholecystectomy', 'cholecystectomy', 'Normal Cholecystectomy (Gallstone PANC']","['Ninety-day mean total costs', '90-day total costs', '30-day length-of-stay (LOS', '90-day healthcare utilization and costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}]","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",98.0,0.0223891,"Ninety-day mean total costs were $14,974 (early) versus $16,190 (control) (cost ratio [CR], 0.92; 95% CI, 0.73-1.15, p=0.47) with mean absolute difference of $1,216 less (95% CI, -$4,782 to $2,349, p = 0.50) per patient in the early group.","[{'ForeName': 'Kayla D', 'Initials': 'KD', 'LastName': 'Isbell', 'Affiliation': 'Department of Surgery; Center for Surgical Trials and Evidence-based Practice.'}, {'ForeName': 'Shuyan', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Department of Surgery; Center for Surgical Trials and Evidence-based Practice.'}, {'ForeName': 'Shah-Jahan M', 'Initials': 'SM', 'LastName': 'Dodwad', 'Affiliation': 'Department of Surgery; Center for Surgical Trials and Evidence-based Practice.'}, {'ForeName': 'Elenir Bc', 'Initials': 'EB', 'LastName': 'Avritscher', 'Affiliation': 'Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School at the University of Texas Health Science Center, Houston, TX.'}, {'ForeName': 'Krislynn M', 'Initials': 'KM', 'LastName': 'Mueck', 'Affiliation': 'Department of Surgery; Center for Surgical Trials and Evidence-based Practice.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bernardi', 'Affiliation': 'Department of Surgery; Center for Surgical Trials and Evidence-based Practice.'}, {'ForeName': 'Gabrielle E', 'Initials': 'GE', 'LastName': 'Hatton', 'Affiliation': 'Department of Surgery; Center for Surgical Trials and Evidence-based Practice.'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'University of Houston, HCA Healthcare Kingwood, Kingwood, TX.'}, {'ForeName': 'Tien C', 'Initials': 'TC', 'LastName': 'Ko', 'Affiliation': 'Department of Surgery.'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'Department of Surgery; Center for Surgical Trials and Evidence-based Practice; Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School at the University of Texas Health Science Center, Houston, TX. Electronic address: Lillian.S.Kao@uth.tmc.edu.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2021.06.023']
926,34324397,"Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression.","Objectives:  To evaluate long-term safety and effectiveness of lurasidone in children and adolescents with bipolar depression.  Methods:  Participants, ages 10-17 years, with bipolar depression, who completed 6 weeks of double-blind (DB) treatment with lurasidone or placebo were enrolled in a 2-year, open-label (OL) extension study of lurasidone (20-80 mg/d). The primary effectiveness measure was the Children's Depression Rating Scale, Revised (CDRS-R).  Results:  A total of 306 participants entered the 2-year extension study; 195 (63.7%) completed 52 weeks, and 168 (54.9%) completed 104 weeks of treatment. For all participants entering the extension study, mean change in CDRS from OL baseline was -13.4 at week 52, and -16.4 at week 104 (-11.3 at last observation carried forward [LOCF]-endpoint). Overall, 31 participants (10.1%) discontinued due to an adverse event (AE); the three most common AEs were headache (23.9%), nausea (16.4%), and somnolence (9.8%). OL treatment with lurasidone was associated with few effects on metabolic parameters or prolactin. Mean change from DB baseline in weight was +4.25 kg at week 52 (vs. an expected weight gain of +3.76 kg), and +6.75 kg at week 104 (vs. an expected weight gain of +6.67 kg), based on the sex- and age-matched United States Center for Disease Control normative data.  Conclusions:  For youth with bipolar depression, up to 2 years of treatment with lurasidone was generally well tolerated, safe, and effective with relatively low rates of discontinuation due to AEs, minimal effects on weight, metabolic parameters or prolactin, and continued improvement in depressive symptoms. Clinical Trial Registration number: NCT01914393.",2021,"Overall, 31 participants (10.1%) discontinued due to an adverse event (AE); the three most common AEs were headache (23.9%), nausea (16.4%), and somnolence (9.8%).","['children and adolescents with bipolar depression', 'Methods:  Participants, ages 10-17 years, with bipolar depression, who completed 6 weeks of double-blind (DB) treatment with', 'Children and Adolescents with Bipolar Depression', '306 participants entered the 2-year extension study; 195 (63.7%) completed 52 weeks, and 168 (54.9%) completed 104 weeks of treatment']","['Lurasidone', 'lurasidone', 'lurasidone or placebo']","['Tolerability, Safety, and Effectiveness', 'headache', 'metabolic parameters or prolactin', 'nausea', 'somnolence', ""Children's Depression Rating Scale, Revised (CDRS-R"", 'Mean change from DB baseline in weight']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",306.0,0.269412,"Overall, 31 participants (10.1%) discontinued due to an adverse event (AE); the three most common AEs were headache (23.9%), nausea (16.4%), and somnolence (9.8%).","[{'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'DelBello', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tocco', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, USA.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Pikalov', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Fort Lee, New Jersey, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Fort Lee, New Jersey, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldman', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2021.0040']
927,34282568,Human Systemic Immune Response to Ingestion of the Oral Probiotic Streptococcus salivarius BLIS K12.,"Streptococcus salivarius K12 is an oral probiotic known to contribute to protection against oral pathogenic bacteria in humans. Studies of immune responses to S. salivarius K12 have focused on the oral cavity, and systemic immune responses have not yet been reported. The aim of this study was to identify acute systemic immune responses to the commercial product, S. salivarius BLIS K12, in a double-blinded, placebo-controlled human clinical trial. It was hypothesised that consumption of S. salivarius BLIS K12 would induce an anti-inflammatory response and a decrease in pro-inflammatory cytokines. Blood samples were obtained from participants prior to a single dose of S. salivarius BLIS K12 or a placebo and then secondary blood samples were obtained 24 h and 7 days post-consumption. Samples were analysed using multi-parametric flow cytometry, to quantify immune cell frequency changes, and by a LEGENDplex assay of human inflammatory cytokines. Consumption of S. salivarius BLIS K12 was associated with increased levels of IL-8 at 24 h. The frequency of Tregs increased in samples taken 7 days after probiotic consumption, and IL-10 concentrations were higher at 7 days than 24 h after consumption. There was no difference in the frequency and/or activation of CD4 +  T cells, CD8 +  T cells, B cells and NK cells. Interestingly, there was an increase in IL-12, 7 days after the consumption of S. salivarius BLIS K12. Collectively, this research demonstrates that ingestion of the probiotic S. salivarius K12 can induce changes in the systemic immune response. The implications of the generation and type of immune response warrant further study to determine potential health benefits.",2021,"There was no difference in the frequency and/or activation of CD4 +  T cells, CD8 +  T cells, B cells and NK cells.",['humans'],['placebo'],"['pro-inflammatory cytokines', 'levels of IL-8', 'systemic immune response', 'frequency of Tregs', 'IL-10 concentrations', 'frequency and/or activation of CD4 +  T cells, CD8 +  T cells, B cells and NK cells', 'IL-12', 'Consumption of S. salivarius']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.205072,"There was no difference in the frequency and/or activation of CD4 +  T cells, CD8 +  T cells, B cells and NK cells.","[{'ForeName': 'Gemma L', 'Initials': 'GL', 'LastName': 'Laws', 'Affiliation': 'Department of Microbiology and Immunology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'John D F', 'Initials': 'JDF', 'LastName': 'Hale', 'Affiliation': 'Blis Technologies, Dunedin, New Zealand.'}, {'ForeName': 'Roslyn A', 'Initials': 'RA', 'LastName': 'Kemp', 'Affiliation': 'Department of Microbiology and Immunology, University of Otago, Dunedin, New Zealand. roslyn.kemp@otago.ac.nz.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-021-09822-3']
928,34285318,Combined neuromuscular electrical stimulation with motor control exercise can improve lumbar multifidus activation in individuals with recurrent low back pain.,"Motor control exercise (MCE) is commonly prescribed for patients with low back pain. Although MCE can improve clinical outcomes, lumbar multifidus muscle (LM) activation remains unchanged. Neuromuscular electrical stimulation (NMES) can be used to re-activate motor units prior to MCE which should result in increased LM activation. Therefore, this study aimed to explore the immediate effects of NMES combined with MCE on LM activation and motor performance. Twenty-five participants without low back pain (NoLBP) and 35 participants with movement control impairment (MCI) were recruited. Participants with MCI were further randomized to combined NMES with MCE (COMB) or sham-NMES with MCE (MCE) group. Ultrasound imaging was used to measure LM thickness at rest, maximum voluntary isometric contraction (MVIC), and NMES with MVIC. These data were used to calculate LM activation. Quadruped rocking backward was used to represent motor performance. LM activation and motor performance were measured at baseline and after one-session of intervention. Results showed that both COMB and MCE groups had significantly lower (P < 0.05) LM activation compared with NoLBP group at baseline. Additionally, both COMB and MCE groups demonstrated significant improvement (P < 0.05) in motor performance while COMB group demonstrated significantly greater improvement (P < 0.05) in LM activation compared with MCE group. Individuals with MCI still have persisting LM activation deficit. Our key findings suggest that combined NMES and MCE may have better ability to improve LM activation in individuals with MCI. These findings would support the utility of NMES to induce a priming effect before MCE.",2021,"Additionally, both COMB and MCE groups demonstrated significant improvement (P < 0.05) in motor performance while COMB group demonstrated significantly greater improvement (P < 0.05) in LM activation compared with MCE group.","['Participants with MCI', 'individuals with MCI', 'patients with low back pain', 'individuals with recurrent low back pain', 'Twenty-five participants without low back pain (NoLBP) and 35 participants with movement control impairment (MCI) were recruited']","['Motor control exercise (MCE', 'Combined neuromuscular electrical stimulation with motor control exercise', 'combined NMES with MCE (COMB) or sham-NMES with MCE (MCE', 'NoLBP', 'MCE', 'Neuromuscular electrical stimulation (NMES', 'NMES combined with MCE']","['LM activation and motor performance', 'motor performance', 'LM activation', 'clinical outcomes, lumbar multifidus muscle (LM) activation', 'LM thickness at rest, maximum voluntary isometric contraction (MVIC), and NMES with MVIC', 'lumbar multifidus activation']","[{'cui': 'C0427083', 'cui_str': 'Control of movement'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0751648', 'cui_str': 'Recurrent Low Back Pain'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0025641', 'cui_str': 'Metergoline'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]",25.0,0.0486654,"Additionally, both COMB and MCE groups demonstrated significant improvement (P < 0.05) in motor performance while COMB group demonstrated significantly greater improvement (P < 0.05) in LM activation compared with MCE group.","[{'ForeName': 'Sranya', 'Initials': 'S', 'LastName': 'Songjaroen', 'Affiliation': 'Biomechanics and Sport Lab, Faculty of Physical Therapy, Mahidol University, 999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom, 73170, Thailand.'}, {'ForeName': 'Panakorn', 'Initials': 'P', 'LastName': 'Sungnak', 'Affiliation': 'Biomechanics and Sport Lab, Faculty of Physical Therapy, Mahidol University, 999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom, 73170, Thailand.'}, {'ForeName': 'Pagamas', 'Initials': 'P', 'LastName': 'Piriyaprasarth', 'Affiliation': 'Motor Control and Neural Plasticity Lab, Faculty of Physical Therapy, Mahidol University, 999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom, 73170, Thailand.'}, {'ForeName': 'Hsing-Kuo', 'Initials': 'HK', 'LastName': 'Wang', 'Affiliation': 'Sports Physiotherapy Lab, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, No. 17, Xuzhou Rd., Zhongzheng District, Taipei City, 100, Taiwan.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Laskin', 'Affiliation': 'School of Physical Therapy and Rehabilitation Science, University of Montana, 135 Skaggs Building, Missoula, MT, 59812, USA.'}, {'ForeName': 'Peemongkon', 'Initials': 'P', 'LastName': 'Wattananon', 'Affiliation': 'Biomechanics and Sport Lab, Faculty of Physical Therapy, Mahidol University, 999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom, 73170, Thailand. peemongkon.wat@mahidol.ac.th.'}]",Scientific reports,['10.1038/s41598-021-94402-2']
929,34285247,Enhancing reappraisal of negative emotional memories with transcranial direct current stimulation.,"Reappraisal of negative memories and experiences is central for mental health and well-being. Deficiency of reappraisal lies at the core of many psychiatric disorders and is a key target for treatment. Here we apply transcranial direct current stimulation (tDCS) to enhance reappraisal of negative emotional memories. In a randomised, sham-controlled, 2 × 2 between-subject and double-blinded study, we applied single sessions of anodal and sham tDCS over the right dorsolateral prefrontal cortex (dlPFC) of 101 healthy participants while reappraising a personal negative memory or engaging in a control task. We hypothesised that (i) reappraisal decreases negative valence, arousal and evaluations of the memory and leads to improved decision making, and (ii) tDCS leads to additional changes in these reappraisal outcomes. In line with these hypotheses, participants' personal memories were rated as less negative and less arousing following reappraisal. Anodal tDCS during reappraisal was associated with significant short-term reductions in negative valence compared to sham stimulation. Our results indicate that tDCS may enhance some of the effects of reappraisal. If replicated, our findings suggest potential benefits elicited by tDCS stimulation that may help optimise current treatment approaches for psychiatric disorders.",2021,Anodal tDCS during reappraisal was associated with significant short-term reductions in negative valence compared to sham stimulation.,['101 healthy participants while reappraising a'],"['transcranial direct current stimulation', 'tDCS', 'transcranial direct current stimulation (tDCS', 'Anodal tDCS', 'anodal and sham tDCS', 'personal negative memory or engaging in a control task']",['negative valence'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0557930', 'cui_str': 'Unpleasant memories'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}]",101.0,0.101979,Anodal tDCS during reappraisal was associated with significant short-term reductions in negative valence compared to sham stimulation.,"[{'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Doerig', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, Lenggstrasse 31, 8032, Zurich, Switzerland.'}, {'ForeName': 'Rosa J', 'Initials': 'RJ', 'LastName': 'Seinsche', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, Lenggstrasse 31, 8032, Zurich, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Moisa', 'Affiliation': 'Department of Economics, Urich Center for Neuroeconomics (ZNE), University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, Lenggstrasse 31, 8032, Zurich, Switzerland.'}, {'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Ruff', 'Affiliation': 'Department of Economics, Urich Center for Neuroeconomics (ZNE), University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Kleim', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, Lenggstrasse 31, 8032, Zurich, Switzerland. birgit.kleim@uzh.ch.'}]",Scientific reports,['10.1038/s41598-021-93647-1']
930,34288556,Sex difference in initial thermoregulatory response to dehydrated exercise in the heat.,"Although it is well established that dehydration has a negative impact on thermoregulation during exercise in the heat, it is unclear whether this effect of dehydration is different between men and women, or across the phases of the menstrual cycle (MC). Twelve men and seven women (men: 20 ± 2 years, 70.13 ± 10.5 kg, 173.4 ± 6.0 cm, 54.2 ± 8.6 ml kg -1   min -1  ; women: 20 ± 2 years, 57.21 ± 7.58 kg, 161 ± 5 cm, 40.39 ± 3.26 ml kg -1   min -1  ) completed trials either euhydrated (urine specific gravity, USG ≤ 1.020, Euhy) or dehydrated (USG > 1.020, Dehy). Trial order was randomized and counterbalanced; men completed two trials (MEuhy and MDehy) and women completed four over two MC phases (late follicular: days 10-13, FDehy, FEuhy; midluteal: days 18-22, LDehy, LEuhy). Each trial consisted of 1.5 h, split into two 30 min blocks of exercise (B1 and B2, 15 min at 11 W/kg & 15 min at 7 W/kg) separated by 15 min rest in between and after. Rectal temperature (T re  ) was measured continuously and estimated sweat loss was calculated from the body mass measured before and after each block of exercise. When dehydrated, the rate of rise in T re  was greater in women in the first block of exercise compared to men, independently of the MC phase (MDehy: 0.03 ± 0.03°C/min, FDehy: 0.06 ± 0.02, LDehy: 0.06 ± 0.02, p = 0.03). Estimated sweat loss was lower in all groups in B1 compared to B2 when dehydrated (p < 0.05), with no difference between sexes for either hydration condition. These data suggest that women may be more sensitive to the negative thermoregulatory effects of dehydration during the early stages of exercise in the heat.",2021,"Estimated sweat loss was lower in all groups in B1 compared to B2 when dehydrated (p < 0.05), with no difference between sexes for either hydration condition.","['min -1  ; women: 20\xa0±\xa02\xa0years, 57.21\xa0±\xa07.58\xa0kg, 161\xa0±\xa05\xa0cm, 40.39\xa0±\xa03.26', 'Twelve men and seven women (men: 20\xa0±\xa02\xa0years, 70.13\xa0±\xa010.5\xa0kg, 173.4\xa0±\xa06.0\xa0cm, 54.2\xa0±\xa08.6\xa0ml\xa0kg -1']","['FDehy', 'dehydrated exercise', 'euhydrated (urine specific gravity, USG\xa0≤\xa01.020, Euhy) or dehydrated ']","['Rectal temperature (T re  ', 'rate of rise in T re', 'Estimated sweat loss']","[{'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517808', 'cui_str': '54.2'}, {'cui': 'C4517879', 'cui_str': '8.6'}]","[{'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0202517', 'cui_str': 'Urinalysis, specific gravity measurement'}]","[{'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}]",,0.0739794,"Estimated sweat loss was lower in all groups in B1 compared to B2 when dehydrated (p < 0.05), with no difference between sexes for either hydration condition.","[{'ForeName': 'Gabrielle E W', 'Initials': 'GEW', 'LastName': 'Giersch', 'Affiliation': 'United States Army Research Institute for Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Morrissey', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Cody R', 'Initials': 'CR', 'LastName': 'Butler', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Abigail T', 'Initials': 'AT', 'LastName': 'Colburn', 'Affiliation': 'Hydration Science Laboratory, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Zachariah S', 'Initials': 'ZS', 'LastName': 'Demarais', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Stavros A', 'Initials': 'SA', 'LastName': 'Kavouras', 'Affiliation': 'Hydration Science Laboratory, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Jay', 'Affiliation': 'Thermal Ergonomics Laboratory, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Charkoudian', 'Affiliation': 'United States Army Research Institute for Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Casa', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, Storrs, CT, USA.'}]",Physiological reports,['10.14814/phy2.14947']
931,34288547,Phase 1 Study Evaluating the Effects of the Proton Pump Inhibitor Rabeprazole and Food on the Pharmacokinetics of Lorlatinib in Healthy Participants.,"Lorlatinib is approved worldwide as treatment for anaplastic lymphoma kinase-positive and c-ros oncogene 1-positive non-small cell lung cancer. The objectives of this phase 1, open-label crossover study (NCT02569554) in healthy adult participants were to determine (1) the effects of the proton pump inhibitor (PPI) rabeprazole on lorlatinib pharmacokinetics (PK), (2) the effects of a high-fat meal on lorlatinib PK, and (3) the relative bioavailability of an oral solution to tablet formulation of lorlatinib under fasted conditions. Participants were followed on-study for ≥50 days after the first dose of lorlatinib. Participants received treatments over 4 periods, with a washout of ≥10 days between consecutive lorlatinib doses. Twenty-seven participants were enrolled and received lorlatinib, and all were assessed for PK and safety. Results showed no effect of multiple doses of rabeprazole on the total plasma exposure of a single oral dose of lorlatinib 100-mg tablets. The results also indicated that a high-fat meal had no effect on lorlatinib PK after a single 100-mg oral dose. In addition, the relative bioavailability of lorlatinib oral solution compared with lorlatinib tablets was complete (approximately 108%). The safety profile of lorlatinib was consistent with that reported in previous studies, and most treatment-related adverse events were mild to moderate. These data indicate that lorlatinib can be administered with drugs that modify gastric acid, including PPIs, without restriction. These results also confirm that lorlatinib can be administered regardless of food intake.",2021,Results showed no effect of multiple doses of rabeprazole on the total plasma exposure of a single oral dose of lorlatinib 100-mg tablets.,"['Twenty-seven participants', 'healthy adult participants', 'Healthy Participants']","['rabeprazole', 'Proton Pump Inhibitor Rabeprazole', 'proton pump inhibitor (PPI) rabeprazole']","['lorlatinib PK', 'total plasma exposure', 'relative bioavailability']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C4080091', 'cui_str': 'Lorlatinib'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.134216,Results showed no effect of multiple doses of rabeprazole on the total plasma exposure of a single oral dose of lorlatinib 100-mg tablets.,"[{'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Pfizer Inc., San Diego, California, USA.'}, {'ForeName': 'Melissa T', 'Initials': 'MT', 'LastName': ""O'Gorman"", 'Affiliation': 'Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Nepal', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Lee P', 'Initials': 'LP', 'LastName': 'James', 'Affiliation': 'Pfizer Inc., New York, New York, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ginman', 'Affiliation': 'Pfizer Inc., South Lyon, Michigan, USA.'}, {'ForeName': 'Yazdi K', 'Initials': 'YK', 'LastName': 'Pithavala', 'Affiliation': 'Pfizer Inc., La Jolla, California, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1000']
932,34288973,"Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study.","BACKGROUND


This study was designed to evaluate the beneficial effects of a botanical extract combination containing soy isoflavone extract (100mg), Aframomum melegueta seed dry extract (50 mg), and Punica granatum skin dry extract (100mg) on health-related Quality of Life in healthy Spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the validated Cervantes Scale.
METHODS AND RESULTS


Fifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective, placebo-controlled, double-blind study. Women were randomized to receive treatment with either the botanical combination (250 mg daily divided into two doses) or placebo for eight weeks. At the beginning and end of the study, health-related Quality of Life was assessed using the Cervantes Scale. Subjects treated with the botanical extract, compared to subjects in the placebo group, showed a significant improvement in the Global health-related Quality of Life score (38% [11.3-50.0]% vs. 18.8% [0-37.7]%; P = 0.04) on the Cervantes Scale and, specifically, in the menopause and health domain (13.6% [0-45.4]% vs. 40.7% [20.6-61.0]%; P = 0.05). By contrast, there were no significant changes in the psychic, sexuality, and couple relationship related domains of the Cervantes Scale. Patients who concluded the study did not report substantial side effects.
CONCLUSION


Short-term intake of the botanical combination improved the Global Quality of Life of climateric women, according to the Cervantes Scale. Since this is a pilot trial, results should be analysed with caution.
TRIAL REGISTRATION


NCT04381026; ClinicalTrial.gov (retrospectively registered).",2021,"Subjects treated with the botanical extract, compared to subjects in the placebo group, showed a significant improvement in the Global health-related Quality of Life score (38% [11.3-50.0]% vs. 18.8% [0-37.7]%; P = 0.04) on the Cervantes Scale and, specifically, in the menopause and health domain (13.6% [0-45.4]% vs. 40.7% [20.6-61.0]%; P = 0.05).","['Fifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective', 'healthy Spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the validated Cervantes Scale', 'menopausal Spanish women']","['botanical combination', 'new botanical combination', 'botanical extract combination containing soy isoflavone extract', 'placebo', 'Aframomum melegueta seed dry extract (50 mg), and Punica granatum skin dry extract']","['psychic, sexuality, and couple relationship related domains of the Cervantes Scale', 'health-related Quality of Life', 'Global health-related Quality of Life score', 'Global Quality of Life of climateric women', 'quality of life', 'menopause and health domain']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025345', 'cui_str': 'Disorder of menstruation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0025319', 'cui_str': 'Menopausal syndrome'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1136306', 'cui_str': 'Aframomum'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C1720167', 'cui_str': 'Dry extract'}, {'cui': 'C1509685', 'cui_str': 'POMEGRANATE FRUIT EXTRACT'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]",57.0,0.0585202,"Subjects treated with the botanical extract, compared to subjects in the placebo group, showed a significant improvement in the Global health-related Quality of Life score (38% [11.3-50.0]% vs. 18.8% [0-37.7]%; P = 0.04) on the Cervantes Scale and, specifically, in the menopause and health domain (13.6% [0-45.4]% vs. 40.7% [20.6-61.0]%; P = 0.05).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-Ríos', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, Agüimes, Las Palmas, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Barber', 'Affiliation': 'Gynecological Division, Baren Clinic, Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wiebe', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, Agüimes, Las Palmas, Spain.'}, {'ForeName': 'Rubén P', 'Initials': 'RP', 'LastName': 'Machín', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, Agüimes, Las Palmas, Spain.'}, {'ForeName': 'Tanausú', 'Initials': 'T', 'LastName': 'Vega-Morales', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, Agüimes, Las Palmas, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Chirino', 'Affiliation': 'Department of Biochemistry, Molecular Biology, Physiology, Genetics and Immunology, Universidad de las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Las Palmas, Spain.'}]",PloS one,['10.1371/journal.pone.0255015']
933,34292205,Noninvasive Cervical Vagal Nerve Stimulation Alters Brain Activity During Traumatic Stress in Individuals With Posttraumatic Stress Disorder.,"OBJECTIVE


Posttraumatic stress disorder (PTSD) is a disabling condition affecting a large segment of the population; however, current treatment options have limitations. New interventions that target the neurobiological alterations underlying symptoms of PTSD could be highly beneficial. Transcutaneous cervical (neck) vagal nerve stimulation (tcVNS) has the potential to represent such an intervention. The goal of this study was to determine the effects of tcVNS on neural responses to reminders of traumatic stress in PTSD.
METHODS


Twenty-two participants were randomized to receive either sham (n = 11) or active (n = 11) tcVNS stimulation in conjunction with exposure to neutral and personalized traumatic stress scripts with high-resolution positron emission tomography scanning with radiolabeled water for brain blood flow measurements.
RESULTS


Compared with sham, tcVNS increased brain activations during trauma scripts (p < .005) within the bilateral frontal and temporal lobes, left hippocampus, posterior cingulate, and anterior cingulate (dorsal and pregenual), and right postcentral gyrus. Greater deactivations (p < .005) with tcVNS were observed within the bilateral frontal and parietal lobes and left thalamus. Compared with tcVNS, sham elicited greater activations (p < .005) in the bilateral frontal lobe, left precentral gyrus, precuneus, and thalamus, and right temporal and parietal lobes, hippocampus, insula, and posterior cingulate. Greater (p < .005) deactivations were observed with sham in the right temporal lobe, posterior cingulate, hippocampus, left anterior cingulate, and bilateral cerebellum.
CONCLUSIONS


tcVNS increased anterior cingulate and hippocampus activation during trauma scripts, potentially indicating a reversal of neurobiological changes with PTSD consistent with improved autonomic control.Trial Registration: No. NCT02992899.",2021,"Compared to tcVNS, sham elicited greater activations (p < 0.005) in the bilateral frontal lobe, left precentral gyrus, precuneus, and thalamus, and right temporal and parietal lobes, hippocampus, insula, and posterior cingulate.","['Twenty-two participants', 'Posttraumatic stress disorder (PTSD', 'Individuals with Posttraumatic Stress Disorder']","['Invasive Cervical Vagal Nerve Stimulation Alters Brain Activity', 'Transcutaneous cervical (neck) vagal nerve stimulation (tcVNS', 'tcVNS', 'active (n = 11) tcVNS stimulation in conjunction with exposure to neutral and personalized traumatic stress scripts with High-Resolution Positron Emission Tomography scanning with radiolabeled water for brain blood flow measurements']","['brain activations', 'anterior cingulate and hippocampus activation', 'bilateral frontal and temporal lobes, left hippocampus, posterior cingulate, and anterior cingulate (dorsal and pregenual), and right postcentral gyrus', 'Greater deactivations', 'bilateral frontal lobe, left precentral gyrus, precuneus, and thalamus, and right temporal and parietal lobes, hippocampus, insula, and posterior cingulate']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005776', 'cui_str': 'Circulatory function tests'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152302', 'cui_str': 'Structure of postcentral gyrus'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0152299', 'cui_str': 'Structure of ascending frontal gyrus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}]",22.0,0.0996097,"Compared to tcVNS, sham elicited greater activations (p < 0.005) in the bilateral frontal lobe, left precentral gyrus, precuneus, and thalamus, and right temporal and parietal lobes, hippocampus, insula, and posterior cingulate.","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences (Wittbrodt, Bremner), Emory University School of Medicine; School of Electrical and Computer Engineering (Gurel, Shandhi, Gazi, Inan), Georgia Institute of Technology; Department of Radiology (Nye) and Imaging Sciences, Emory University School of Medicine; Department of Epidemiology (Shah, Pearce, Murrah, Shallenberger, Vaccarino), Rollins School of Public Health, Emory University; Division of Cardiology, Department of Medicine (Shah, Vaccarino), Emory University School of Medicine, Atlanta; Atlanta VA Medical Center (Shah, Bremner), Decatur; Department of Biostatistics and Bioinformatics, Rollins School of Public Health (Ko), Emory University; and Wallace H. Coulter Department of Biomedical Engineering (Inan), Georgia Institute of Technology, Atlanta, Georgia.'}, {'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': ''}, {'ForeName': 'Jonathon A', 'Initials': 'JA', 'LastName': 'Nye', 'Affiliation': ''}, {'ForeName': 'Md Mobashir H', 'Initials': 'MMH', 'LastName': 'Shandhi', 'Affiliation': ''}, {'ForeName': 'Asim H', 'Initials': 'AH', 'LastName': 'Gazi', 'Affiliation': ''}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Pearce', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Murrah', 'Affiliation': ''}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Lucy H', 'Initials': 'LH', 'LastName': 'Shallenberger', 'Affiliation': ''}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': ''}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': ''}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000987']
934,34289935,Male vitamin D status and male factor infertility.,"OBJECTIVE


To determine the association between vitamin D levels in the male partner and fertility outcomes in couples with mild male factor infertility.
DESIGN


Secondary analysis of a randomized, controlled trial.
SETTING


Nine fertility centers in the United States.
PATIENT(S)


Men (n = 154) with sperm concentration between 5 and 15 million/mL, motility ≤40%, or normal morphology ≤4% were eligible. Female partners were ovulatory, ≤40 years old, and had documented tubal patency.
INTERVENTION(S)


Men provided semen and blood at baseline for semen analysis and 25-hydroxyvitamin D (25(OH)D) levels. They were randomly assigned to receive a vitamin formulation including vitamin D 2,000 IU daily or placebo for up to 6 months. Couples attempted to conceive naturally during the first 3 months and with clomiphene citrate with intrauterine insemination of the female partner in months 4 through 6.
MAIN OUTCOME MEASURE(S)


Primary: sperm concentration, motility, morphology, and DNA fragmentation at baseline. Secondary: cumulative pregnancy, miscarriage, and live birth rates.
RESULT(S)


Semen parameters and sperm DNA fragmentation were not statistically significantly different between men with vitamin D deficiency and men with 25(OH)D levels ≥20 ng/mL. In addition, clinical pregnancy and live birth rates were similar. Male 25(OH)D level <20 ng/mL was associated with a higher rate of pregnancy loss (adjusted odds ratio 9.0; 95% confidence interval 1.3 to 61.3).
CONCLUSION(S)


Vitamin D deficiency in the male partner did not significantly impact semen parameters or treatment outcomes. Further study is warranted to better characterize the rate of miscarriage in couples with male vitamin D deficiency.",2021,Semen parameters and sperm DNA fragmentation were not statistically significantly different between men with vitamin D deficiency and men with 25(OH)D levels ≥20 ng/mL.,"['couples with male vitamin D deficiency', 'men with vitamin D deficiency and men with 25(OH)D levels ≥20 ng/mL', 'Men (n = 154) with sperm concentration between 5 and 15 million/mL, motility ≤40%, or normal morphology', 'Male vitamin D status and male factor infertility', 'Nine fertility centers in the United States', 'couples with mild male factor infertility', 'Female partners were ovulatory, ≤40 years old, and had documented tubal patency']","['vitamin D levels', 'clomiphene citrate', 'vitamin formulation including vitamin D 2,000 IU daily or placebo']","['25-hydroxyvitamin D (25(OH)D) levels', 'sperm concentration, motility, morphology, and DNA fragmentation', 'rate of pregnancy loss', 'clinical pregnancy and live birth rates', 'Semen parameters and sperm DNA fragmentation', 'cumulative pregnancy, miscarriage, and live birth rates', 'rate of miscarriage']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C1960956', 'cui_str': 'Million/milliliter'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",154.0,0.484409,Semen parameters and sperm DNA fragmentation were not statistically significantly different between men with vitamin D deficiency and men with 25(OH)D levels ≥20 ng/mL.,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Banks', 'Affiliation': 'Department of Obstetrics and Gynecology, Virginia Commonwealth University Health, Richmond, Virginia. Electronic address: Nicole.Banks@vcuhealth.org.'}, {'ForeName': 'Fangbai', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Krawetz', 'Affiliation': 'Department of Obstetrics and Gynecology and Center for Molecular Medicine and Genetics, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Coward', 'Affiliation': 'Department of Urology, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Masson', 'Affiliation': 'Department of Urology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, University of California, San Francisco, California.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Trussell', 'Affiliation': 'Department of Urology, Upstate University Hospital, Syracuse, New York.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Anne Z', 'Initials': 'AZ', 'LastName': 'Steiner', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina.'}]",Fertility and sterility,['10.1016/j.fertnstert.2021.06.035']
935,34294842,Comparison of ocular surface assessment and adherence between preserved and preservative-free latanoprost in glaucoma: a parallel-grouped randomized trial.,"Given that nonadherence is related to subject characteristics and drug tolerance and preserved eye drops tend to be more intolerable than preservative-free ones, we conducted a phase 4, parallel-grouped, investigator-blind, active-control, randomized, multicenter study. A total of 51 patients with intraocular pressure (IOP) ≥ 15 mmHg diagnosed with open-angle glaucoma or ocular hypertension were randomly assigned to the preserved latanoprost group (n = 26) and the preservative-free latanoprost group (n = 25). The efficacy variables were corneal/conjunctival staining grade, Ocular Surface Disease Index (OSDI), adherence at 12 weeks after the first administration; corneal/conjunctival staining grade at 4 weeks; and IOP, tear break-up time (TBUT), and hyperemia score at 4 and 12 weeks. The safety variables included visual acuity and drug tolerance questionnaire results. There was no statistically significant difference in corneal/conjunctival staining grade, OSDI, or TBUT between the groups at 4 and 12 weeks. However, the adherence rate was higher and the hyperemia score was lower in the preservative-free group than in the preserved group. The severity and duration of stinging/burning sensation were lower in the preservative-free group than in the preserved group. Overall, preservative-free latanoprost showed better ocular tolerance assessed by hyperemia scores and stinging/burning symptoms following higher adherence than preserved latanoprost.",2021,"There was no statistically significant difference in corneal/conjunctival staining grade, OSDI, or TBUT between the groups at 4 and 12 weeks.","['51 patients with intraocular pressure (IOP)\u2009≥\u200915\xa0mmHg diagnosed with open-angle glaucoma or ocular hypertension', 'glaucoma']","['latanoprost', 'preservative-free latanoprost', 'preserved and preservative-free latanoprost']","['visual acuity and drug tolerance questionnaire results', 'adherence rate', 'hyperemia score', 'ocular tolerance assessed by hyperemia scores and stinging/burning symptoms', 'corneal/conjunctival staining grade, OSDI, or TBUT', 'severity and duration of stinging/burning sensation', 'corneal/conjunctival staining grade, Ocular Surface Disease Index (OSDI), adherence', 'IOP, tear break-up time (TBUT), and hyperemia score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]","[{'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0677500', 'cui_str': 'Stinging'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",51.0,0.0620044,"There was no statistically significant difference in corneal/conjunctival staining grade, OSDI, or TBUT between the groups at 4 and 12 weeks.","[{'ForeName': 'Dai Woo', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Kyungpook National University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Jonghoon', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.'}, {'ForeName': 'Chang Kyu', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Myungjin', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, CHA Bundang Medical Center, CHA University, 59 Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-712, Republic of Korea.'}, {'ForeName': 'Sohyeon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, CHA Bundang Medical Center, CHA University, 59 Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-712, Republic of Korea.'}, {'ForeName': 'Seungsoo', 'Initials': 'S', 'LastName': 'Rho', 'Affiliation': 'Department of Ophthalmology, CHA Bundang Medical Center, CHA University, 59 Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-712, Republic of Korea. harryrho@gmail.com.'}]",Scientific reports,['10.1038/s41598-021-94574-x']
936,34293081,"Neither low salivary amylase activity, cooling cooked white rice, nor single nucleotide polymorphisms in starch-digesting enzymes reduce glycemic index or starch digestibility: a randomized, crossover trial in healthy adults.","BACKGROUND


It was suggested that low salivary-amylase activity (SAA) and cooling or stir-frying cooked starch decreases its digestibility and glycemic index.
OBJECTIVE


We determined the effects of SAA, cooling, and single-nucleotide polymorphisms (SNPs) in the salivary amylase (AMY1), pancreatic amylase (AMY2A, AMY2B), maltase-glucoamylase (MGAM), and sucrase-isomaltase (SI) genes on starch digestibility and glycemic index of cooked polished rice.
METHODS


Healthy subjects [pilot, n = 12; main, n = 20 with low-SAA (<50 U/mL), and n = 20 with high-SAA (>105 U/mL)] consumed test meals containing 25 g (pilot) or 50 g (main) available carbohydrate at a contract research organization using open-label (pilot) or assessor-blinded (main), randomized, crossover, Latin-square designs (trial registration: NCT03667963). Pilot-trial test meals were dextrose, freshly cooked polished rice, cooked rice cooled overnight, stir-fried hot rice, or stir-fried cold rice. Main-trial test meals were dextrose, dextrose plus 10 g lactulose, plain hot rice, or plain cold rice. In both trials, blood glucose was measured fasting and at intervals over 2 h. In the main trial, breath hydrogen was measured fasting and hourly for 6 h to estimate in vivo starch digestibility. Data were analyzed by repeated-measures ANOVA for the main effects of temperature and stir-frying (pilot trial) or the main effects of SAA and temperature (main trial) and their interactions. Effects of 24 single nucleotide polymorphisms (SNPs) were assessed separately. Means were considered to be equivalent if the 95% CI of the differences were within ±20% of the comparator mean for glucose response/glycemic index or ±7% for digestibility.
RESULTS


Pilot: neither temperature nor stir-frying significantly affected glucose incremental AUC (primary endpoint, n = 12). Main: mean ± SEM glycemic index (primary endpoint, n = 40) was equivalent for low-SAA compared with high-SAA (73 ± 3 vs. 75 ± 4) and cold rice compared with hot rice (75 ± 3 vs. 70 ± 3). Estimated starch digestibility (n = 39) was equivalent for low-SAA compared with high-SAA (95% ± 1% vs. 92% ± 1%) and hot rice compared with cold rice (94% ± 1% vs. 93% ± 1%). No meaningful associations were observed between genotypes and starch digestibility or glycemic index for any of the SNPs.
CONCLUSIONS


The results do not support the hypotheses that low-SAA, cooling, and common genetic variations in starch-digesting enzymes affect the glycemic index or in vivo carbohydrate digestibility of cooked polished rice. This trial was registered at clinicaltrials.gov as NCT03667963.",2021,"RESULTS


Pilot: neither temperature nor stir-frying significantly affected glucose incremental AUC (primary endpoint, n = 12).","['Healthy subjects [pilot, n\xa0=\xa012; main, n\xa0=\xa020 with low-SAA (<50 U/mL), and n\xa0=\xa020 with high-SAA (>105 U/mL', 'healthy adults']","['24 single nucleotide polymorphisms (SNPs', 'dextrose, freshly cooked polished rice, cooked rice cooled overnight, stir-fried hot rice, or stir-fried cold rice', 'test meals containing 25\xa0g (pilot) or 50\xa0g (main) available carbohydrate at a contract research organization using open-label (pilot) or assessor-blinded (main', 'dextrose, dextrose plus 10\xa0g lactulose, plain hot rice, or plain cold rice']","['blood glucose', 'Estimated starch digestibility', 'genotypes and starch digestibility or glycemic index', 'temperature nor stir-frying significantly affected glucose incremental AUC', 'glycemic index or starch digestibility', 'glucose response/glycemic index or ±7% for digestibility', 'Main: mean\xa0±\xa0SEM glycemic index', 'digestibility and glycemic index', 'salivary amylase (AMY1), pancreatic amylase (AMY2A, AMY2B), maltase-glucoamylase (MGAM), and sucrase-isomaltase (SI) genes on starch digestibility and glycemic index of cooked polished rice']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0443452', 'cui_str': 'Salivary amylase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0443452', 'cui_str': 'Salivary amylase'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0002272', 'cui_str': 'Alpha-glucosidase'}, {'cui': 'C0028941', 'cui_str': 'Oligo-1,6-glucosidase'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0035567', 'cui_str': 'Rice'}]",,0.154104,"RESULTS


Pilot: neither temperature nor stir-frying significantly affected glucose incremental AUC (primary endpoint, n = 12).","[{'ForeName': 'Thomas M S', 'Initials': 'TMS', 'LastName': 'Wolever', 'Affiliation': 'Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Sohemy', 'Affiliation': 'Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Adish', 'Initials': 'A', 'LastName': 'Ezatagha', 'Affiliation': 'INQUIS Clinical Research, Ltd (formerly GI Labs), Toronto, Ontario, Canada.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Zurbau', 'Affiliation': 'Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Jenkins', 'Affiliation': 'INQUIS Clinical Research, Ltd (formerly GI Labs), Toronto, Ontario, Canada.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab228']
937,34293034,Peer video feedback builds basic life support skills: A randomized controlled non-inferiority trial.,"INTRODUCTION


Training Basic Life Support saves lives. However, current BLS training approaches are time-consuming and costly. Alternative cost-efficient and effective training methods are highly needed. The present study evaluated whether a video-feedback supported peer-guided Basic Life Support training approach achieves similar practical performance as a standard instructor-guided training in laypersons.
METHODS


In a randomized controlled non-inferiority trial, 288 first-year medical students were randomized to two study arms with different Basic Life Support training methods: 1) Standard Instructor Feedback (SIF) or 2) a Peer Video Feedback (PVF). Outcome parameters were objective data for Basic Life Support performance (compression depth and rate) from a resuscitation manikin with recording software as well as overall Basic Life Support performance and subjective confidence. Non-inferiority margins (Δ) for these outcome parameters and sample size calculation were based on previous studies with Standard Instructor Feedback. Two-sided 95% confidence intervals were employed to determine significance of non-inferiority.
RESULTS


Results confirmed non-inferiority of Peer Video Feedback to Standard Instructor Feedback for compression depth (proportion difference PVF-SIF = 2.9%; 95% CI: -8.2% to 14.1%; Δ = -19%), overall Basic Life Support performance (proportion difference PVF-SIF = 6.7%; 95% CI: 0.0% to 14.3%; Δ = -27%) and subjective confidence for CPR performance (proportion difference PVF-SIF = -0.01; 95% CI: -0.18-0.17; Δ = -0.5) and emergency situations (proportion difference PVF-SIF = -0.02; 95% CI: -0.21-0.18; Δ = -0.5). Results for compression rate were inconclusive.
DISCUSSION


Peer Video Feedback achieves comparable results as standard instructor-based training methods. It is an easy-to-apply and cost-efficient alternative to standard Basic Life Support training methods. To improve performance with respect to compression rate, additional implementation of a metronome is recommended.",2021,"RESULTS


Results confirmed non-inferiority of Peer Video Feedback to Standard Instructor Feedback for compression depth (proportion difference PVF-SIF = 2.9%; 95% CI: -8.2% to 14.1%; Δ = -19%), overall Basic Life Support performance (proportion difference PVF-SIF = 6.7%; 95% CI: 0.0% to 14.3%; Δ = -27%) and subjective confidence for CPR performance (proportion difference PVF-SIF = -0.01; 95% CI: -0.18-0.17; Δ = -0.5) and emergency situations (proportion difference PVF-SIF = -0.02; 95% CI: -0.21-0.18; Δ = -0.5).",['288 first-year medical students'],"['Peer video feedback builds basic life support skills', 'video-feedback supported peer-guided Basic Life Support training approach', 'Basic Life Support training methods: 1) Standard Instructor Feedback (SIF) or 2) a Peer Video Feedback (PVF']","['objective data for Basic Life Support performance (compression depth and rate) from a resuscitation manikin with recording software as well as overall Basic Life Support performance and subjective confidence. Non-inferiority margins', 'inferiority of Peer Video Feedback to Standard Instructor Feedback for compression depth', 'compression rate', 'overall Basic Life Support performance', 'subjective confidence for CPR performance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",288.0,0.0772282,"RESULTS


Results confirmed non-inferiority of Peer Video Feedback to Standard Instructor Feedback for compression depth (proportion difference PVF-SIF = 2.9%; 95% CI: -8.2% to 14.1%; Δ = -19%), overall Basic Life Support performance (proportion difference PVF-SIF = 6.7%; 95% CI: 0.0% to 14.3%; Δ = -27%) and subjective confidence for CPR performance (proportion difference PVF-SIF = -0.01; 95% CI: -0.18-0.17; Δ = -0.5) and emergency situations (proportion difference PVF-SIF = -0.02; 95% CI: -0.21-0.18; Δ = -0.5).","[{'ForeName': 'Saša', 'Initials': 'S', 'LastName': 'Sopka', 'Affiliation': 'Medical Faculty, AIXTRA-Competency Center for Training and Patient Safety, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Hahn', 'Affiliation': 'Medical Faculty, AIXTRA-Competency Center for Training and Patient Safety, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Medical Faculty, AIXTRA-Competency Center for Training and Patient Safety, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Kim Hannah', 'Initials': 'KH', 'LastName': 'Pears', 'Affiliation': 'Medical Faculty, AIXTRA-Competency Center for Training and Patient Safety, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Rossaint', 'Affiliation': 'Medical Faculty, Department of Anaesthesiology, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Rudolph', 'Affiliation': 'Center for Medical Simulation, Boston, MA, United States of America.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Klasen', 'Affiliation': 'Medical Faculty, AIXTRA-Competency Center for Training and Patient Safety, RWTH Aachen University, Aachen, Germany.'}]",PloS one,['10.1371/journal.pone.0254923']
938,34293018,Sports safety matting diminishes cardiopulmonary resuscitation quality and increases rescuer perceived exertion.,"OBJECTIVES


Compliant surfaces beneath a casualty diminish the quality of cardiopulmonary resuscitation (CPR) in clinical environments. To examine this issue in a sporting environment, we assessed chest compression quality and rescuer exertion upon compliant sports safety matting.
METHODS


Twenty-seven advanced life support providers volunteered (13 male/14 female; mass = 79.0 ± 12.5 kg; stature = 1.77 ± 0.09 m). Participants performed 5 × 2 min, randomized bouts of continuous chest compressions on a mannequin, upon five surfaces: solid floor; low-compliance matting; low-compliance matting with a backboard; high-compliance matting; high-compliance matting with a backboard. Measures included chest compression depth and rate, percentage of adequate compressions, and rescuer heart rate and perceived exertion.
RESULTS


Chest compression depth and rate were significantly lower upon high-compliance matting relative to other surfaces (p<0.05). The percentage of adequate compressions (depth ≥50 mm) was lowest upon high-compliance matting (40 ± 39%) versus low-compliance matting (60 ± 36%) and low-compliance matting with a backboard (59 ± 39%). Perceived exertion was significantly greater upon high-compliance matting versus floor, low-compliance matting, and low-compliance matting with a backboard (p<0.05).
CONCLUSION


Providers of CPR should be alerted to the detrimental effects of compliant safety matting in a sporting environment and prepare to alter the targeted compression depth and rescuer rotation intervals accordingly.",2021,"RESULTS


Chest compression depth and rate were significantly lower upon high-compliance matting relative to other surfaces (p<0.05).",['Twenty-seven advanced life support providers volunteered (13 male/14 female; mass = 79.0 ± 12.5 kg; stature = 1.77 ± 0.09 m'],"['continuous chest compressions on a mannequin, upon five surfaces: solid floor; low-compliance matting; low-compliance matting with a backboard; high-compliance matting; high-compliance matting with a backboard']","['chest compression depth and rate, percentage of adequate compressions, and rescuer heart rate and perceived exertion', 'Perceived exertion']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0419055', 'cui_str': 'Advanced life support'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517419', 'cui_str': '0.09'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0183440', 'cui_str': 'Spine board'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",27.0,0.0266023,"RESULTS


Chest compression depth and rate were significantly lower upon high-compliance matting relative to other surfaces (p<0.05).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kingston', 'Affiliation': 'Department of Anaesthesia and Critical Care, Barnsley District General Hospital, Barnsley, South Yorkshire, United Kingdom.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Tiller', 'Affiliation': 'Institute of Respiratory Medicine and Exercise Physiology, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Centre, Torrance, California, United States of America.'}, {'ForeName': 'Elle', 'Initials': 'E', 'LastName': 'Partington', 'Affiliation': 'Newcastle Medical School, Newcastle University, Newcastle Upon Tyne, Tyne and Wear, United Kingdom.'}, {'ForeName': 'Mukhtar', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Emergency Medicine Department, Leeds Teaching Hospitals, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'School of Clinical and Applied Sciences, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'Johnson', 'Affiliation': 'School of Clinical and Applied Sciences, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Nigel A', 'Initials': 'NA', 'LastName': 'Callender', 'Affiliation': 'School of Clinical and Applied Sciences, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0254800']
939,34298148,Beta cell functionality and hepatic insulin resistance are major contributors to type 2 diabetes remission and starting pharmacological therapy: from CORDIOPREV randomized controlled trial.,"In order to assess whether previous hepatic IR (Hepatic-IR fasting ) and beta-cell functionality could modulate type 2 diabetes remission and the need for starting glucose-lowering treatment, newly-diagnosed type 2 diabetes participants who had never received glucose-lowering treatment (190 out of 1002) from the CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (a prospective, randomized and controlled clinical trial), were randomized to consume a Mediterranean or a low-fat diet. Type 2 diabetes remission was defined according to the American Diabetes Association recommendation for levels of HbA1c, fasting plasma glucose and 2h plasma glucose after oral glucose tolerance test, and having maintained them for at least 2 consecutive years. Patients were classified according to the median of Hepatic-IR fasting  and beta-cell functionality, measured as the disposition index (DI) at baseline. Cox proportional hazards regression determined the potential for Hepatic-IR fasting  and DI indexes as predictors of diabetes remission and the probability of starting pharmacological treatment after a 5-year follow-up. Low-Hepatic-IR fasting  or high-DI patients had a higher probability of diabetes remission than high-Hepatic-IR fasting  or low-DI subjects (HR:1.79; 95% CI 1.06-3.05; and HR:2.66; 95% CI 1.60-4.43, respectively) after a dietary intervention with no pharmacological treatment and no weight loss. The combination of low-Hepatic-IR fasting  and high-DI presented the highest probability of remission (HR:4.63; 95% CI 2.00-10.70). Among patients maintaining diabetes, those with high- Hepatic-IR fasting  and low-DI showed the highest risk of starting glucose-lowering therapy (HR:3.24;95% CI 1.50-7.02). Newly-diagnosed type 2 diabetes patients with better beta-cell functionality and lower Hepatic-IR fasting  had a higher probability of type 2 diabetes remission in a dietary intervention without pharmacological treatment or weight loss, whereas among patients not achieving remission, those with worse beta-cell functionality and higher Hepatic-IR fasting  index had the highest risk of starting glucose-lowering treatment after 5 years of follow-up.",2021,TRANSLATIONAL SIGNIFICANCE: Patients with lower hepatic insulin resistance and better beta cell functionality had a higher probability of remission without significant weight loss or pharmacological treatment.,['newly-diagnosed type 2 diabetes participants who had never received glucose-lowering treatment (190 out of 1002'],['Mediterranean or a low-fat diet'],"['weight loss', 'median of Hepatic-IR fasting  and beta-cell functionality', 'probability of diabetes remission', 'levels of HbA1c, fasting plasma glucose and 2h plasma glucose', 'highest risk of starting glucose-lowering therapy']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",1002.0,0.0716499,TRANSLATIONAL SIGNIFICANCE: Patients with lower hepatic insulin resistance and better beta cell functionality had a higher probability of remission without significant weight loss or pharmacological treatment.,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Roncero-Ramos', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Gutierrez-Mariscal', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gomez-Delgado', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Villasanta-Gonzalez', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Torres-Peña', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Silvia De La', 'Initials': 'S', 'LastName': 'Cruz-Ares', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Oriol A', 'Initials': 'OA', 'LastName': 'Rangel-Zuñiga', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Raul M', 'Initials': 'RM', 'LastName': 'Luque', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain; Maimonides Institute for Biomedical Research of Córdoba (IMIBIC), Cordoba, Spain; Department of Cell Biology, Physiology, and Immunology, University of Córdoba, Cordoba, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Ordovas', 'Affiliation': 'Nutrition and Genomics Laboratory, J.M.-US Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, Boston, Massachusetts; IMDEA Alimentacion, CNIC, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Delgado-Lista', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Perez-Martinez', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Camargo', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Alcalá-Diaz', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Miranda', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain. Electronic address: jlopezmir@uco.es.'}]",Translational research : the journal of laboratory and clinical medicine,['10.1016/j.trsl.2021.07.001']
940,34302449,"Safety, Pharmacokinetics, Pharmacodynamics, and Formulation of Liver-Distributed Farnesoid X-Receptor Agonist TERN-101 in Healthy Volunteers.","TERN-101 is a nonsteroidal farnesoid X-receptor agonist being developed for the treatment of nonalcoholic steatohepatitis (NASH). We assessed the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TERN-101 capsule and tablet formulations in healthy volunteers. In a randomized, double-blind, placebo-controlled study, 38 participants were enrolled and randomized to receive placebo or 25-, 75-, or 150-mg TERN-101 capsules orally once daily for 7 days. In a separate open-label PK and formulation-bridging study, 16 participants received single doses of TERN-101 tablets (5 and 25 mg) or capsules (25 mg). TERN-101 was overall well-tolerated in this healthy volunteer population; no pruritus was reported. TERN-101 capsule administration over 7 days resulted in decreases in serum 7α-hydroxy-4-cholesten-3-one that were sustained for 24 hours after the last dose (maximum suppression 91% from baseline), indicating target engagement in the liver. TERN-101 capsules exhibited less than dose-proportional PK. Relative to capsules, TERN-101 tablets showed increased bioavailability, with 24-hour plasma exposure of the 5-mg tablet similar to that of the 25-mg capsule. There was no significant effect of food on exposure. The overall safety, PK, and PD profiles of TERN-101 support its further evaluation for the treatment of NASH.",2021,"TERN-101 capsule administration over 7 days resulted in decreases in serum 7α-hydroxy-4-cholesten-3-one that were sustained for 24 hours after the last dose (maximum suppression 91% from baseline), indicating target engagement in the liver.","['38 participants', 'healthy volunteers', 'Healthy Volunteers']","['placebo', 'TERN-101 tablets', 'placebo or 25-, 75-, or 150-mg TERN-101 capsules']","['safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TERN-101 capsule and tablet formulations', 'Safety, Pharmacokinetics, Pharmacodynamics, and Formulation of Liver', 'serum 7α-hydroxy-4-cholesten-3-one', 'bioavailability, with 24-hour plasma exposure', 'overall safety, PK, and PD profiles of TERN-101']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0325881', 'cui_str': 'Tern'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0325881', 'cui_str': 'Tern'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0055520', 'cui_str': 'cholest-4-en-3-one'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",38.0,0.136267,"TERN-101 capsule administration over 7 days resulted in decreases in serum 7α-hydroxy-4-cholesten-3-one that were sustained for 24 hours after the last dose (maximum suppression 91% from baseline), indicating target engagement in the liver.","[{'ForeName': 'Yujin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Terns Pharmaceuticals, Inc., Foster City, California, USA.'}, {'ForeName': 'Daria B', 'Initials': 'DB', 'LastName': 'Crittenden', 'Affiliation': 'Terns Pharmaceuticals, Inc., Foster City, California, USA.'}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Eng', 'Affiliation': 'Terns Pharmaceuticals, Inc., Foster City, California, USA.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Terns Pharmaceuticals, Inc., Foster City, California, USA.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'Terns Pharmaceuticals, Inc., Foster City, California, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Chung', 'Affiliation': 'Terns Pharmaceuticals, Inc., Foster City, California, USA.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Fenaux', 'Affiliation': 'Terns Pharmaceuticals, Inc., Foster City, California, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Klucher', 'Affiliation': 'Terns Pharmaceuticals, Inc., Foster City, California, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Terns Pharmaceuticals, Inc., Foster City, California, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': 'Terns Pharmaceuticals, Inc., Foster City, California, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Quirk', 'Affiliation': 'Terns Pharmaceuticals, Inc., Foster City, California, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Charlton', 'Affiliation': 'Center for Liver Diseases, The University of Chicago Medicine, Chicago, Illinois, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.960']
941,34329774,Hepatic Fat Reduction Due to Resmetirom in Patients With Nonalcoholic Steatohepatitis Is Associated With Improvement of Quality of Life.,"BACKGROUND & AIMS


Nonalcoholic steatohepatitis (NASH) is a chronic liver disease associated with adverse clinical outcomes and impaired health-related quality of life (HRQL).
METHODS


Patients with biopsy-proven non-cirrhotic NASH with hepatic fat fraction of ≥10% by magnetic resonance imaging-proton density fat fraction were enrolled in a phase 2, multicenter, double-blind, randomized, placebo-controlled study of resmetirom. HRQL was assessed using Short Form-36 throughout 36 weeks of treatment.
RESULTS


One hundred twenty-five NASH patients were enrolled (50 ± 11 years old, 50% male, 94% white, body mass index 35 ± 6 kg/m 2 , 39% with diabetes mellitus). Of these, 84 patients received 80 mg of resmetirom daily, and 41 received placebo. At baseline, HRQL scores were not different from general population norms (Physical Component Summary [PCS] 47.9 ± 9.3 vs 50, Mental Component Summary 50.4 ± 10.0 vs 50; all P > .05). By treatment week 12, patients who received resmetirom experienced improvement of Bodily Pain and Short Form-6D utility scores (P < .05); no HRQL improvement was noted in placebo (all P > .05). Improvement in PCS continued up to week 36 of treatment with resmetirom, again with no improvement in placebo group (all P > .05). Adjusted for the baseline score and clinicodemographic confounders, meeting the endpoint of a decrease in proton density fat fraction of ≥30% by week 12 (met by 54 of 116 treatment completers; 47 of 54 on resmetirom) was independently associated with greater improvements in Physical Functioning and PCS scores at week 36 (P < .05). Patients with improvement in NASH and fibrosis on liver biopsy also showed improvement in components of HRQL.
CONCLUSIONS


Patients with NASH treated who improved their hepatic fat fraction and/or Nonalcoholic Fatty Liver Disease Activity Score on serial liver biopsy experienced improvement of HRQL. Further studies are needed to confirm long-term sustainability of that improvement. ClinicalTrials.gov #NCT02912260.",2021,"By treatment week 12, patients who received resmetirom experienced improvement of Bodily Pain and SF-6D utility scores (p<0.05); no HRQL improvement was noted in placebo (all p>0.05).","['Patients with Nonalcoholic Steatohepatitis', 'Patients with biopsy-proven non-cirrhotic NASH with hepatic fat fraction of ≥10% by MRI-proton density fat fraction (MRI-PDFF', '125 NASH patients were enrolled (50±11 years old, 50% male, 94% white, BMI 35±6, 39% with diabetes mellitus']",['placebo'],"['Physical Functioning and PCS scores', 'NASH and fibrosis on liver biopsy', 'HRQL scores', 'Quality of Life', 'Bodily Pain and SF-6D utility scores', 'HRQL', 'PDFF', 'HRQL improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",125.0,0.183688,"By treatment week 12, patients who received resmetirom experienced improvement of Bodily Pain and SF-6D utility scores (p<0.05); no HRQL improvement was noted in placebo (all p>0.05).","[{'ForeName': 'Zobair M', 'Initials': 'ZM', 'LastName': 'Younossi', 'Affiliation': 'Center for Liver Disease, Department of Medicine, Inova Health System, Falls Church, Virginia. Electronic address: zobair.younossi@inova.org.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Stepanova', 'Affiliation': 'Center for Outcomes Research in Liver Diseases, Washington, District of Columbia.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Taub', 'Affiliation': 'Madrigal Pharmaceuticals, Conshohocken, Pennsylvania.'}, {'ForeName': 'Jordan Mark', 'Initials': 'JM', 'LastName': 'Barbone', 'Affiliation': 'Madrigal Pharmaceuticals, Conshohocken, Pennsylvania.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom; Pinnacle Clinical Research, San Antonio, Texas.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2021.07.039']
942,34331010,Exploring cannabidiol effects on inflammatory markers in individuals with cocaine use disorder: a randomized controlled trial.,"Cocaine use disorder (CUD) is a major public health issue associated with physical, social, and psychological problems. Excessive and repeated cocaine use induces oxidative stress leading to a systemic inflammatory response. Cannabidiol (CBD) has gained substantial interest for its anti-inflammatory properties, safety, and tolerability profile. However, CBD anti-inflammatory properties have yet to be confirmed in humans. This exploratory study is based on a single-site randomized controlled trial that enrolled participants with CUD between 18 and 65 years, randomized (1:1) to daily receive either CBD (800 mg) or placebo for 92 days. The trial was divided into a 10-day detoxification (phase I) followed by a 12-week outpatient follow-up (phase II). Blood samples were collected from 48 participants at baseline, day 8, week 4, and week 12 and were analyzed to determine monocytes and lymphocytes phenotypes, and concentrations of various inflammatory markers such as cytokines. We used generalized estimating equations to detect group differences. Participants treated with CBD had lower levels of interleukin-6 (p = 0.017), vascular endothelial growth factor (p = 0.032), intermediate monocytes CD14 + CD16 +  (p = 0.024), and natural killer CD56 neg CD16 hi  (p = 0.000) compared with participants receiving placebo. CD25 + CD4 + T cells were higher in the CBD group (p = 0.007). No significant group difference was observed for B lymphocytes. This study suggests that CBD may exert anti-inflammatory effects in individuals with CUD.",2021,CD25 + CD4 + T cells were higher in the CBD group (p = 0.007).,"['individuals with cocaine use disorder', 'enrolled participants with CUD between 18 and 65 years', 'individuals with CUD']","['CBD', 'Cocaine', 'cocaine', 'Cannabidiol (CBD', 'placebo']","['Blood samples', 'CD25 + CD4 + T cells', 'levels of interleukin-6', 'vascular endothelial growth factor', 'natural killer CD56 neg CD16 hi', 'intermediate monocytes CD14 + CD16 ', 'inflammatory markers', 'B lymphocytes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0007507', 'cui_str': 'Lymphocyte antigen CD25'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0108754', 'cui_str': 'Lymphocyte antigen CD56'}, {'cui': 'C0108747', 'cui_str': 'Lymphocyte antigen CD16'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}]",,0.184272,CD25 + CD4 + T cells were higher in the CBD group (p = 0.007).,"[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Morissette', 'Affiliation': 'Faculty of Medicine, Department of Psychiatry and Addictology, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Violaine', 'Initials': 'V', 'LastName': 'Mongeau-Pérusse', 'Affiliation': 'Faculty of Medicine, Department of Psychiatry and Addictology, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Rizkallah', 'Affiliation': 'Faculty of Medicine, Department of Psychiatry and Addictology, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Paméla', 'Initials': 'P', 'LastName': 'Thébault', 'Affiliation': ""Research Centre of Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, QC, Canada.""}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Lepage', 'Affiliation': ""Research Centre of Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, QC, Canada.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Brissette', 'Affiliation': ""Research Centre of Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, QC, Canada.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruneau', 'Affiliation': ""Research Centre of Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, QC, Canada.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dubreucq', 'Affiliation': 'Faculty of Medicine, Department of Psychiatry and Addictology, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Stip', 'Affiliation': 'Faculty of Medicine, Department of Psychiatry and Addictology, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Cailhier', 'Affiliation': ""Research Centre of Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, QC, Canada.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Jutras-Aswad', 'Affiliation': 'Faculty of Medicine, Department of Psychiatry and Addictology, Université de Montréal, Montreal, QC, Canada. didier.jutras-aswad@umontreal.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01098-z']
943,34393186,Change of plasma amylin after bariatric surgery challenged by oral glucose is associated with remission of type 2 diabetes mellitus.,"BACKGROUND


Gastric bypass (GB) and sleeve gastrectomy (SG) were found to achieve different remission rates in the treatment of type 2 diabetes (T2DM). The alteration in several gut hormones after bariatric surgery has been demonstrated to play a key role for T2DM remission. Nevertheless, amylin, one of the diabetes-associated peptides, so far has an undetermined position on T2DM remission after bariatric surgery.
METHODS


Sixty eligible patients with T2DM (GB, 30; SG, 30) were initially enrolled in the hospital-based randomized trial. Twenty patients (GB, 10; SG, 10) who met the inclusion criteria and agreed to undergo 75-g oral glucose tolerance test (OGTT) were recruited. The recruited subjects underwent anthropometric measurements, routine laboratory tests, and 75-g OGTT before and 1 year after bariatric surgery. Enzyme immunoassays for plasma amylin were analyzed.
RESULTS


All subjects that underwent GB and half of those who underwent SG achieved T2DM remission. Plasma amylin levels significantly decreased 60-90 min after OGTT in the GB group (p < 0.05) and 30-60 minutes after OGTT in the SG group (p < 0.05). Significantly decreased plasma amylin levels were observed at 30-90 minutes after OGTT in the noncomplete remitters of the GB group (p < 0.05). Plasma amylin levels initially increased (p < 0.05) within 30 minutes after OGTT and then decreased (p < 0.05) in the next 30-minute interval in the nonremitters of the SG group.
CONCLUSION


Postoral glucose challenge amylin levels could be as one of the parameters to evaluate T2DM remission after bariatric surgery, especially in those after SG.",2021,Plasma amylin levels significantly decreased 60-90 min after OGTT in the GB group (p < 0.05) and 30-60 min after OGTT in the SG group (p < 0.05).,"['Twenty patients (GB, 10; SG, 10) who met the inclusion criteria and agreed to undergo 75-g oral glucose tolerance test (OGTT) were recruited', 'Sixty eligible patients with T2DM (GB, 30; SG, 30) were initially enrolled in the hospital-based randomized trial']",['Gastric bypass (GB) and sleeve gastrectomy (SG'],"['T2DM remission', 'Plasma amylin levels', 'plasma amylin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",20.0,0.0251305,Plasma amylin levels significantly decreased 60-90 min after OGTT in the GB group (p < 0.05) and 30-60 min after OGTT in the SG group (p < 0.05).,"[{'ForeName': 'Jiunn-Wei', 'Initials': 'JW', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan, ROC.'}, {'ForeName': 'Pei-Yu', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency & Critical Care Medicine, Cheng-Hsin General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Hsien-Hao', 'Initials': 'HH', 'LastName': 'Huang', 'Affiliation': 'Department of Emergency Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yeh', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Cheng-Hsin General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shu-Chun', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chang-Gung Institute of Technology, Taoyuan, Taiwan, ROC.'}, {'ForeName': 'Wei-Jei', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan, ROC.'}, {'ForeName': 'Chih-Yen', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000602']
944,34334330,A Prospective Economic Analysis of Early Outcome Data From the Alliance A041202/ CCTG CLC.2 Randomized Phase III Trial Of Bendamustine-Rituximab Compared With Ibrutinib-Based Regimens in Untreated Older Patients With Chronic Lymphocytic Leukemia.,"INTRODUCTION


The Alliance A041202/CCTG CLC.2 trial demonstrated superior progression-free survival with ibrutinib-based therapy compared to chemoimmunotherapy with bendamustine-rituximab (BR) in previously untreated older patients with chronic lymphocytic leukemia. We completed a prospective trial-based economic analysis of Canadian patients to study the direct medical costs and quality-adjusted benefit associated with these therapies.
METHODS


Mean survival was calculated using the restricted mean survival method from randomization to the study time-horizon of 24 months. Health state utilities were collected using the EuroQOL EQ-5D instrument with Canadian tariffs applied to calculate quality-adjusted life years (QALYs). Costs were applied to resource utilization data (expressed in 2019 US dollars). We examined costs and QALYs associated ibrutinib, ibrutinib with rituximab (IR), and BR therapy.
RESULTS


A total of 55 patients were enrolled; two patients were excluded from the analysis. On-protocol costs (associated with protocol-specified resource use) were higher for patients receiving ibrutinib (mean $189,335; P < 0.0001) and IR (mean $219,908; P < 0.0001) compared to BR (mean $51,345), driven by higher acquisition costs for ibrutinib. Total mean costs (over 2-years) were $192,615 with ibrutinib, $223,761 with IR, and $55,413 with BR (P < 0.0001 for ibrutinib vs. BR and P < 0.0001 for IR vs. BR). QALYs were similar between the three treatment arms: 1.66 (0.16) for ibrutinib alone, 1.65 (0.24) for IR, and 1.66 (0.17) for BR; therefore, a formal cost-utility analysis was not conducted.
CONCLUSIONS


Direct medical costs are higher for patients receiving ibrutinib-based therapies compared to chemoimmunotherapy in frontline chronic lymphocytic leukemia, with the cost of ibrutinib representing a key driver.",2021,"QALYs were similar between the three treatment arms: 1.66 (0.16) for ibrutinib alone, 1.65 (0.24) for IR, and 1.66 (0.17) for BR; therefore, a formal cost-utility analysis was not conducted.
","['older patients with chronic lymphocytic leukemia', 'Untreated Older Patients With Chronic Lymphocytic Leukemia', 'A total of 55 patients were enrolled; two patients were excluded from the analysis', 'Canadian patients']","['rituximab (IR), and BR therapy', 'chemoimmunotherapy with bendamustine-rituximab (BR', 'chemoimmunotherapy', 'Bendamustine-Rituximab']","['Mean survival', 'Health state utilities', 'Total mean costs', 'superior progression-free survival']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C4047978', 'cui_str': 'Rituximab therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",55.0,0.0542092,"QALYs were similar between the three treatment arms: 1.66 (0.16) for ibrutinib alone, 1.65 (0.24) for IR, and 1.66 (0.17) for BR; therefore, a formal cost-utility analysis was not conducted.
","[{'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Cheung', 'Affiliation': 'Division of Hematology, Department of Medicine, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada; Canadian Cancer Trials Group, Queens University, Kingston, Canada. Electronic address: matthew.cheung@sunnybrook.ca.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mittmann', 'Affiliation': 'Canadian Cancer Trials Group, Queens University, Kingston, Canada; Department of Pharmacology and Toxicology and Institute for Health Policy Management and Evaluation, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Owen', 'Affiliation': 'Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Abdel-Samad', 'Affiliation': 'Division of Hematology, The Moncton Hospital, Moncton, Canada.'}, {'ForeName': 'Graeme A M', 'Initials': 'GAM', 'LastName': 'Fraser', 'Affiliation': 'Department of Oncology, Juravinski Cancer Centre, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Selay', 'Initials': 'S', 'LastName': 'Lam', 'Affiliation': 'Victoria Hospital, Western University, London, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Crump', 'Affiliation': 'Canadian Cancer Trials Group, Queens University, Kingston, Canada; Division of Hematology, Department of Medicine, Princess Margaret Hospital and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sperlich', 'Affiliation': 'Centre integre de Santé et de Services Sociaux de la Montérégie-Centre, Greenfield Park, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van der Jagt', 'Affiliation': 'Hematology, Ottawa Hospital, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Anca', 'Initials': 'A', 'LastName': 'Prica', 'Affiliation': 'Canadian Cancer Trials Group, Queens University, Kingston, Canada; Division of Hematology, Department of Medicine, Princess Margaret Hospital and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Couban', 'Affiliation': 'Canadian Cancer Trials Group, Queens University, Kingston, Canada; Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Woyach', 'Affiliation': 'Division of Hematology, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Ruppert', 'Affiliation': 'Division of Hematology, The Ohio State University, Columbus, OH; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Booth', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; Department of Quantitative Health Sciences, and Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Department of Quantitative Health Sciences, and Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'McDonald', 'Affiliation': 'Canadian Cancer Trials Group, Queens University, Kingston, Canada.'}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Shepherd', 'Affiliation': 'Department of Pharmacology and Toxicology and Institute for Health Policy Management and Evaluation, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Yen', 'Affiliation': 'Canadian Cancer Trials Group, Queens University, Kingston, Canada.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': 'Canadian Cancer Trials Group, Queens University, Kingston, Canada.'}, {'ForeName': 'Annette E', 'Initials': 'AE', 'LastName': 'Hay', 'Affiliation': ""Canadian Cancer Trials Group, Queens University, Kingston, Canada; Department of Medicine, Queen's University, Kingston, Ontario, Canada.""}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2021.06.011']
945,34333783,Dentist-patient communication on dental anxiety using the social media: A randomized controlled trial.,"The purpose of the present study was to assess the effects of dentist-patient communication via social media on dental anxiety and to determine the appropriate timing of such communications. In this randomized, double-blinded and controlled trial, we used Instagram's quick replies system to answer patients' questions to alleviate dental anxiety for patients undergoing impacted teeth extraction under local anesthesia. Patients were assigned randomly into four groups according to the timing of such communications: only after (group 1, n = 36), only before (group 2, n = 35), before and after the operation (group 3, n = 36), and a control group who received no communication on social media (group 4, n = 36). Dental anxiety was evaluated one week before (pre-op) and after the operation (post-op) using recognized assessment scales -the Spielberger's State-Trait Anxiety Inventory, Modified Dental Anxiety Scale (MDAS), and Visual Analogue Scale (VAS). The results showed that the post-op values of group 4 had higher anxiety scores than the groups 2 and 3 according to VAS (p < 0.05). Within the groups, the anxiety levels showed a decreasing trend after surgery according to MDAS and VAS scores (p < 0.05). The results of this study suggest that communication with patients before the operation is sufficient to reduce their dental anxiety.",2021,The results showed that the post-op values of group 4 had higher anxiety scores than the groups 2 and 3 according to VAS (p < 0.05).,['patients undergoing impacted teeth extraction under local anesthesia'],"['Dentist-patient communication', 'control group who received no communication on social media', 'dentist-patient communication via social media']","[""Spielberger's State-Trait Anxiety Inventory, Modified Dental Anxiety Scale (MDAS), and Visual Analogue Scale (VAS"", 'anxiety levels', 'dental anxiety', 'anxiety scores', 'Dental anxiety', 'MDAS and VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]",,0.0262625,The results showed that the post-op values of group 4 had higher anxiety scores than the groups 2 and 3 according to VAS (p < 0.05).,"[{'ForeName': 'Efe Can', 'Initials': 'EC', 'LastName': 'Sivrikaya', 'Affiliation': 'Department of Oral Maxillofacial Surgery, Faculty of Dentistry, Karadeniz Teknik University, Trabzon, 61080, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Oral Maxillofacial Surgery, Faculty of Dentistry, Karadeniz Teknik University, Trabzon, 61080, Turkey.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Sivrikaya', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Recep Tayyip Erdogan University, Rize, Turkey.'}]",Scandinavian journal of psychology,['10.1111/sjop.12769']
946,34333138,Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial.,"While extensive literature exists on barriers and strategies to increase minority participation in clinical trials, progress is limited. Few strategies were evaluated in randomized trials. We studied the impact of RECRUIT, a trust-based, cluster randomized minority recruitment trial layered on top of four traditional NIH-funded parent trials (BMT CTN, CABANA, PACES, STEADY-PD III; fifty specialty sites). RECRUIT was conducted from July 2013 through April 2017. Intervention sites implemented trust-based approaches customized to individual sites, promoting relationships between physician-investigators and minority-serving physicians and their minority patients. Control sites implemented only parent trials' recruitment procedures. Adjusting for within-site clustering, we detected no overall intervention effect, odds ratio 1.3 (95% confidence limits 0.7,2.4). Heterogeneity among parent trials may have obscured the effect. Of the four parent trials, three enrolled more minorities in intervention versus control sites. CABANA odds ratio = 4.2 (adjusted 95%CL 1.5,11.3). PACES intervention sites enrolled 63% (10/16) minorities; control sites enrolled one participant in total, a minority, yielding an incalculable odds ratio. STEADY-PD III odds ratio = 2.2 (adjusted 95%CL 0.6,8.5). BMT CTN odds ratio < 1, 0.8 (adjusted 95%CL 0.4,1.8). In conclusion, RECRUIT findings suggest the unique trust-based intervention increased minority recruitment to intervention trials in ¾ of studied trials. Physician-investigators' participation was critical to recruitment success. Lack of commitment to minority recruitment remained a barrier for some physician-investigators, especially in control sites. We recommend prospective physician investigators commit to minority recruitment activities prior to selection as site investigators and trial funding include some compensation for minority recruitment efforts. TRIAL REGISTRATION ClinicalTrials.govNCT01911208.",2021,"Adjusting for within-site clustering, we detected no overall intervention effect, odds ratio 1.3 (95% confidence limits 0.7,2.4).","['PACES intervention sites enrolled 63% (10/16) minorities; control sites enrolled one participant in total, a minority, yielding an incalculable odds ratio']",[],[],"[{'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",[],[],,0.267615,"Adjusting for within-site clustering, we detected no overall intervention effect, odds ratio 1.3 (95% confidence limits 0.7,2.4).","[{'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Tilley', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health (SPH), Houston, TX, United States of America. Electronic address: Barbara.C.Tilley@uth.tmc.edu.'}, {'ForeName': 'Arch G', 'Initials': 'AG', 'LastName': 'Mainous', 'Affiliation': 'Department of Health Services Research Management and Policy, University of Florida College of Public Health and Health Professions, Gainesville, FL, United States of America.'}, {'ForeName': 'Rossybelle P', 'Initials': 'RP', 'LastName': 'Amorrortu', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health (SPH), Houston, TX, United States of America; Department of Cancer Epidemiology, Moffitt Cancer Center, Tampa, FL, United States of America.'}, {'ForeName': 'M Diane', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, NY, United States of America; Department of Family Medicine, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America.'}, {'ForeName': 'Ruosha', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health (SPH), Houston, TX, United States of America.'}, {'ForeName': 'Stacia M', 'Initials': 'SM', 'LastName': 'DeSantis', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health (SPH), Houston, TX, United States of America.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston School of Public Health, Houston, TX, United States of America.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Koch', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Marvella E', 'Initials': 'ME', 'LastName': 'Ford', 'Affiliation': 'Hollings Cancer Center, Population Science and Health Disparities, Medical University of South Carolina, Charleston, SC, United States of America.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Diaz', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC, United States of America.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Alvidrez', 'Affiliation': 'National Institute on Minority Health and Health Disparities, Bethesda, MD, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2021.106519']
947,34303223,Closeness-inducing discussions with a romantic partner increase cortisol and testosterone.,"Despite progress in understanding the social neuroendocrinology of close relationship processes, most work has focused on negative experiences, such as relationship conflict or stress. As a result, much less is known about the neuroendocrine implications of positive, emotionally intimate relationship experiences. In the current study, we randomly assigned 105 dating or married couples to a 30-minute semi-structured discussion task that was designed to elicit either high or low levels of closeness. Participants provided pre- and post-task saliva samples (to assess cortisol and testosterone) and post-task reports of self-disclosure, closeness, attraction, positive and negative affect, and stress. Participants found the discussion conditions comparably positive and enjoyable, but those in the high-closeness condition reported that they disclosed marginally more and felt marginally closer to their partners than those in the low-closeness condition. Participants also showed larger increases in cortisol and testosterone during the high (versus low) closeness discussion, and self-reported disclosure mediated these increases in cortisol and testosterone. Self-reported closeness and other theoretically plausible mediators, such as sexual attraction and excitement, did not mediate changes in either hormone. Taken together, the current findings contribute to our understanding of neuroendocrine changes associated with emotionally intimate relationship experiences. We consider possible explanations for the hormone changes we observed and offer directions for future research on the neuroendocrine implications of close relationship experiences.",2021,"Self-reported closeness and other theoretically plausible mediators, such as sexual attraction and excitement, did not mediate changes in either hormone.",[],['30-minute semi-structured discussion task'],"['cortisol and testosterone', 'cortisol and testosterone) and post-task reports of self-disclosure, closeness, attraction, positive and negative affect, and stress']",[],"[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036596', 'cui_str': 'Self Disclosure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",105.0,0.0895222,"Self-reported closeness and other theoretically plausible mediators, such as sexual attraction and excitement, did not mediate changes in either hormone.","[{'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'University of Michigan, USA. Electronic address: krischin@umich.edu.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Reese', 'Affiliation': 'University of Michigan, USA.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ascigil', 'Affiliation': 'University of Michigan, USA.'}, {'ForeName': 'Lester', 'Initials': 'L', 'LastName': 'Sim', 'Affiliation': 'University of Michigan, USA.'}, {'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Edelstein', 'Affiliation': 'University of Michigan, USA.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105357']
948,34303034,Reduction in Doses to Organs at Risk and Normal Tissue During Breast Radiation Therapy With a Carbon-Fiber Adjustable Reusable Accessory.,"PURPOSE


This pilot study (ClinicalTrials.gov NCT04543851) investigates a novel breast positioning device using a low density, high tensile carbon-fiber cradle to support the breast, remove the inframammary fold, and reduce dose to organs at risk for whole breast radiation therapy in the supine position.
METHODS AND MATERIALS


Thirty patients with inframammary folds ≥1 cm or lateral ptosis in supine treatment position were planned with standard positioning and with a carbon-fiber Adjustable Reusable Accessory (CARA) breast support. Twenty patients received whole breast with or without regional nodal irradiation with 42.5 Gy in 16 fractions or 50 Gy in 25 fractions using CARA. Median body mass index was 32 in this study.
RESULTS


CARA removed all inframammary folds and reduced V20Gy ipsilateral lung,  V105% breast , and V50%  body , without compromising target coverage. Median (range) V20Gy ipsilateral lung  for whole breast radiation therapy was 12.3% (1.4%-28.7%) with standard of care versus 10.9% (1.2%-17.3%) with CARA (Wilcoxon P = .005). Median V105%  breast  was 8.0% (0.0%-29%) with standard of care versus 4.0% (0.0%-23%) with CARA (P = .006) and median V50%  body  was 3056 mL (1476-5285 mL) versus 2780 mL (1415-5123 mL) with CARA (P = .001). CARA was compatible with deep inspiration breath hold and achieved median V25Gy heart  = 0.1% (range 0%-1.9%) for all patients with left breast cancer. Skin reactions with CARA were consistent with historical data and daily variation in treatment setup was consistent with standard supine positioning.
CONCLUSIONS


CARA can reduce V105% breast , lung and normal tissue dose, and remove the inframammary fold for breast patients with large or pendulous breasts and high body mass index treated in the supine position, without compromising target coverage. CARA will undergo further study in a randomized controlled trial.",2021,"V20Gy ipsilateral lung  for whole breast radiotherapy was 12.3% (1.4% - 28.7%) with standard of care versus 10.9% (1.2% - 17.3%) with CARA,","['Thirty patients with infra-mammary folds ≥ 1 cm and/or lateral ptosis in supine treatment position were planned with', '20 patients received']","['whole breast ', 'CARA', 'breast radiotherapy with a Carbon-fibre Adjustable Reusable Accessory (CARA', 'standard positioning and with a Carbon-fibre Adjustable Reusable Accessory (CARA) breast support']","['Skin reactions', 'Median body mass index', 'V20Gy ipsilateral lung  for whole breast radiotherapy', 'Median (range', 'median V25Gy heart']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0108411', 'cui_str': 'Carbon fiber'}, {'cui': 'C0852216', 'cui_str': 'Breast radiotherapies'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",30.0,0.0233383,"V20Gy ipsilateral lung  for whole breast radiotherapy was 12.3% (1.4% - 28.7%) with standard of care versus 10.9% (1.2% - 17.3%) with CARA,","[{'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Duzenli', 'Affiliation': 'Department of Medical Physics, BC Cancer, Vancouver, Canada; Department of Physics and Astronomy, University of British Columbia, Vancouver, Canada; University of British Columbia, Department of Surgery, Division of Radiation Oncology and Developmental Radiotherapeutics, Vancouver, Canada. Electronic address: cduzenli@bccancer.bc.ca.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Koulis', 'Affiliation': 'Department of Radiation Oncology, BC Cancer, Kelowna, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Menna', 'Affiliation': 'Department of Radiation Therapy, BC Cancer, Vancouver, Canada.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Carpentier', 'Affiliation': 'Department of Medical Physics, BC Cancer, Vancouver, Canada; Department of Physics and Astronomy, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Arora', 'Affiliation': 'Department of Radiation Therapy, BC Cancer, Vancouver, Canada.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Coope', 'Affiliation': 'BC Cancer Genome Sciences Centre, Vancouver, Canada.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Gill', 'Affiliation': 'Department of Medical Physics, BC Cancer, Vancouver, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Department of Radiation Oncology, BC Cancer, Vancouver, Canada; University of British Columbia, Department of Surgery, Division of Radiation Oncology and Developmental Radiotherapeutics, Vancouver, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Aquino-Parsons', 'Affiliation': 'Department of Radiation Oncology, BC Cancer, Vancouver, Canada; University of British Columbia, Department of Surgery, Division of Radiation Oncology and Developmental Radiotherapeutics, Vancouver, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': 'Department of Radiation Oncology, BC Cancer, Vancouver, Canada; University of British Columbia, Department of Surgery, Division of Radiation Oncology and Developmental Radiotherapeutics, Vancouver, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'University of British Columbia, School of Population and Public Health, Vancouver, Canada.'}, {'ForeName': 'Paris-Anne', 'Initials': 'PA', 'LastName': 'Ingledew', 'Affiliation': 'Department of Radiation Oncology, BC Cancer, Vancouver, Canada; University of British Columbia, Department of Surgery, Division of Radiation Oncology and Developmental Radiotherapeutics, Vancouver, Canada.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Grahame', 'Affiliation': 'Department of Radiation Therapy, BC Cancer, Vancouver, Canada.'}, {'ForeName': 'Elisa K', 'Initials': 'EK', 'LastName': 'Chan', 'Affiliation': 'Department of Radiation Oncology, BC Cancer, Vancouver, Canada.'}]",Practical radiation oncology,['10.1016/j.prro.2021.06.012']
949,34309480,An Audio-Recorded Hypnosis Intervention for Chronic Pain Management in Cancer Survivors: A Randomized Controlled Pilot Study.,"This pilot study evaluated the feasibility, acceptability, and potential efficacy of a 4-week hypnosis audio-recording intervention in cancer survivors with chronic pain. Forty participants were randomly assigned to treatment ( n  = 21) or wait-list ( n  = 19) conditions. Pain intensity ratings were lower at Week 4 for both groups. The effect size for pain reduction in the treatment group was  d  = 0.25 from baseline to 4 weeks, and the interaction effect (Time x Group) was  F  = .024; η 2 p  = .001. The small interaction effect may be due to the availability of only one recording and large variability in dose. Qualitative data indicated that the intervention's benefits included participation in self-care, improved relaxation, and an opportunity to focus on oneself in a positive way. Further efficacy testing of an audio-recording intervention in a fully powered clinical trial is warranted.",2021,Pain intensity ratings were lower at Week 4 for both groups.,"['cancer survivors with chronic pain', 'Forty participants', 'Cancer Survivors']","['Audio-Recorded Hypnosis Intervention', 'hypnosis audio-recording intervention', 'audio-recording intervention']","['feasibility, acceptability, and potential efficacy', 'pain reduction', 'Pain intensity ratings']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",40.0,0.0703507,Pain intensity ratings were lower at Week 4 for both groups.,"[{'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Eaton', 'Affiliation': 'School of Nursing and Health Studies, University of Washington Bothell, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Beck', 'Affiliation': 'College of Nursing, University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, USA.'}]",The International journal of clinical and experimental hypnosis,['10.1080/00207144.2021.1951119']
950,34313371,Clinical Benefit of Ripretinib Dose Escalation After Disease Progression in Advanced Gastrointestinal Stromal Tumor: An Analysis of the INVICTUS Study.,"BACKGROUND


Ripretinib 150 mg once daily (QD) is indicated for advanced gastrointestinal stromal tumors (GISTs) as at least fourth-line therapy. In INVICTUS, ripretinib intrapatient dose escalation (IPDE) to 150 mg b.i.d. was allowed after progressive disease (PD) on 150 mg QD by blinded independent central review using modified RECIST 1.1. We report the efficacy and safety of ripretinib IPDE to 150 mg b.i.d. after PD among patients randomized to ripretinib 150 mg QD in the INVICTUS study.
MATERIALS AND METHODS


Tumor imaging was performed every 28-day cycle for the first four cycles in the ripretinib 150 mg QD period and then every other cycle, including the 150 mg b.i.d.
PERIOD


Among the ripretinib IPDE patients, progression-free survival (PFS)1 was the time from randomization until PD; PFS2 was the time from the first dose of ripretinib 150 mg b.i.d. to PD or death.
RESULTS


Among 43 ripretinib IPDE patients, median PFS1 was 4.6 months (95% confidence interval [CI], 2.7-6.4) and median PFS2 was 3.7 months (95% CI, 3.1-5.3). Median overall survival was 18.4 months (95% CI, 14.5-not estimable). Ripretinib 150 mg b.i.d. (median duration of treatment 3.7 months) was well tolerated with new or worsening grade 3-4 treatment-emergent adverse events (TEAEs) of anemia in six (14%) and abdominal pain in three (7%) patients. Ripretinib 150 mg b.i.d. was discontinued because of TEAEs in seven (16%) patients.
CONCLUSION


Ripretinib 150 mg b.i.d. after PD on 150 mg QD may provide additional clinically meaningful benefit with an acceptable safety profile in patients with at least fourth-line GISTs.
IMPLICATIONS FOR PRACTICE


Of the 85 patients with advanced gastrointestinal stromal tumor having received at least three prior anticancer therapies randomized to ripretinib 150 mg once daily (QD) in the phase III INVICTUS study, 43 underwent ripretinib intrapatient dose escalation (IPDE) to 150 mg b.i.d. after progressive disease (PD). Median progression-free survival was 4.6 months before and 3.7 months after ripretinib IPDE. The safety profile of ripretinib 150 mg b.i.d. was acceptable. These findings indicate ripretinib IPDE to 150 mg b.i.d. may provide additional clinical benefit in patients with PD on ripretinib 150 mg QD, for whom limited treatment options exist.",2021,", median PFS1 was 4.6 months (95% confidence interval [CI], 2.7-6.4) and median PFS2 was 3.7 months (95% CI, 3.1-5.3).","['patients with ≥fourth-line GIST', 'Advanced Gastrointestinal Stromal Tumor', '43 ripretinib IPDE patients', '85 patients with advanced gastrointestinal stromal tumor having received']","['ripretinib intra-patient dose escalation (IPDE', '≥3 prior anticancer therapies randomized to ripretinib 150 mg once daily (QD', 'ripretinib 150 mg BID', 'Ripretinib 150 mg once daily (QD', 'ripretinib IPDE', 'ripretinib 150 mg QD', 'Ripretinib Dose Escalation']","['progression-free survival (PFS)1', 'median PFS1', 'median PFS2', 'Median overall survival', 'tolerated with new or worsening Grade 3-4 TEAEs of anemia', 'Median progression-free survival', 'abdominal pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",85.0,0.106064,", median PFS1 was 4.6 months (95% confidence interval [CI], 2.7-6.4) and median PFS2 was 3.7 months (95% CI, 3.1-5.3).","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Zalcberg', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Heinrich', 'Affiliation': 'Portland VA Healthcare System and OHSU Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Department of Medical Oncology, Sarcoma Center, West German Cancer Center, Essen, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'University Hospitals Leuven, Department of General Medical Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Serrano', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Royal Marsden and Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': ""D'Amato"", 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Memorial Sloan Kettering Cancer Center & Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Sarcoma Center, Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Somaiah', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Meade', 'Affiliation': 'Deciphera Pharmaceuticals, LLC, Waltham, Massachusetts, USA.'}, {'ForeName': 'Vienna', 'Initials': 'V', 'LastName': 'Reichert', 'Affiliation': 'Deciphera Pharmaceuticals, LLC, Waltham, Massachusetts, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Shi', 'Affiliation': 'Deciphera Pharmaceuticals, LLC, Waltham, Massachusetts, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Sherman', 'Affiliation': 'Deciphera Pharmaceuticals, LLC, Waltham, Massachusetts, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ruiz-Soto', 'Affiliation': 'Deciphera Pharmaceuticals, LLC, Waltham, Massachusetts, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Centre Léon Bérard & Université Claude Bernard, Lyon, France.'}]",The oncologist,['10.1002/onco.13917']
951,34314392,Immediate Effects of a Continuous Peripheral Nerve Block on Postamputation Phantom and Residual Limb Pain: Secondary Outcomes From a Multicenter Randomized Controlled Clinical Trial.,"BACKGROUND


We recently reported that a 6-day continuous peripheral nerve block reduced established postamputation phantom pain 3 weeks after treatment ended. However, the immediate effects of perineural infusion (secondary outcomes) have yet to be reported.
METHODS


Participants from 5 enrolling academic centers with an upper or lower limb amputation and established phantom pain received a single-injection ropivacaine peripheral nerve block(s) and perineural catheter insertion(s). They were subsequently randomized to receive a 6-day ambulatory perineural infusion of either ropivacaine 0.5% or normal saline in a double-masked fashion. Participants were contacted by telephone 1, 7, 14, 21, and 28 days after the infusion started, with pain measured using the Numeric Rating Scale. Treatment effects were assessed using the Wilcoxon rank-sum test at each time point. Adjusting for 4 time points (days 1, 7, 14, and 21), P < .0125 was deemed statistically significant. Significance at 28 days was reported using methods from the original, previously published article.
RESULTS


Pretreatment average phantom and residual pain scores were balanced between the groups. The day after infusion initiation (day 1), average phantom, and residual limb pain intensity was lower in patients receiving local anesthetic (n = 71) versus placebo (n = 73): median [quartiles] of 0 [0-2.5] vs 3.3 [0-5.0], median difference (98.75% confidence interval [CI]) of -1.0 (-3.0 to 0) for phantom pain (P = .001) and 0 [0-0] vs 0 [0-4.3], and median difference 0.0 (-2.0 to 0.0) for residual limb pain (P < .001). Pain's interference with physical and emotional functioning as measured with the interference domain of the Brief Pain Inventory improved during the infusion on day 1 for patients receiving local anesthetic versus placebo: 0 [0-10] vs 10 [0-40], median difference (98.75% CI) of 0.0 (-16.0 to 0.0), P = .002. Following infusion discontinuation (day 6), a few differences were found between the active and placebo treatment groups between days 7 and 21. In general, sample medians for average phantom and residual limb pain scores gradually increased after catheter removal for both treatments, but to a greater degree in the control group until day 28, at which time the differences between the groups returned to statistical significance.
CONCLUSIONS


This secondary analysis suggests that a continuous peripheral nerve block decreases phantom and residual limb pain during the infusion, although few improvements were again detected until day 28, 3 weeks following catheter removal.",2021,"In general, sample medians for average phantom and residual limb pain scores gradually increased after catheter removal for both treatments, but to a greater degree in the control group until day 28, at which time the differences between the groups returned to statistical significance.
",['Participants from 5 enrolling academic centers with an upper or lower limb amputation and established phantom pain received a'],"['single-injection ropivacaine peripheral nerve block(s) and perineural catheter insertion(s', 'Continuous Peripheral Nerve Block', 'placebo', 'local anesthetic', 'ropivacaine 0.5% or normal saline']","['residual pain scores', 'phantom pain', 'Postamputation Phantom and Residual Limb Pain', 'average phantom, and residual limb pain intensity', 'Brief Pain Inventory', 'average phantom and residual limb pain scores', 'residual limb pain']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C3805255', 'cui_str': 'Residual pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",73.0,0.529473,"In general, sample medians for average phantom and residual limb pain scores gradually increased after catheter removal for both treatments, but to a greater degree in the control group until day 28, at which time the differences between the groups returned to statistical significance.
","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Ilfeld', 'Affiliation': 'From the Department of Anesthesiology, University of California San Diego, San Diego, California.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Khatibi', 'Affiliation': 'From the Department of Anesthesiology, University of California San Diego, San Diego, California.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Departments of General Anesthesia and Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Madison', 'Affiliation': 'From the Department of Anesthesiology, University of California San Diego, San Diego, California.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Ali Sakr Esa', 'Affiliation': 'Departments of General Anesthesia and Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Mariano', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Palo Alto Veterans Affairs, Palo Alto, California.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Kent', 'Affiliation': 'Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hanling', 'Affiliation': 'Department of Anesthesiology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Eisenach', 'Affiliation': 'Department of Anesthesiology, The Outcomes Research Consortium, Cleveland, Ohio.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Cohen', 'Affiliation': 'Department of Anesthesiology, Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': 'Departments of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Departments of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Padwal', 'Affiliation': 'Department of Radiology, University of California San Diego, San Diego, California.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Departments of General Anesthesia and Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005673']
952,34319552,"Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial.","INTRODUCTION


Antiviral drugs have shown limited effectiveness in treating patients with coronavirus disease 2019 (COVID-19). We aimed to assess the effects of a favipiravir and hydroxychloroquine combination on treating moderate-to-severe COVID-19 patients.
METHODS


An investigator-initiated, multicenter, open-label, randomized trial at nine hospitals. Eligible patients were adults with moderate-to-severe COVID-19 defined as oxygen saturation (SaO 2 ) of ≤ 94% while breathing ambient air or significant clinical symptoms with chest x-ray changes requiring hospital admission. Randomization was in a 1:1 ratio to receive standard care (control group) or standard care plus favipiravir and hydroxychloroquine. The primary outcome was time to clinical improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital within 14 days. Analyses were done in an intention-to-treat population.
RESULTS


From May 2020 to Jan 2021, 254 patients were enrolled; 129 were assigned to standard of care and 125 to the treatment. The mean age was 52 (± 13) years, and 103 (41%) were women. At randomization, six patients were on invasive mechanical ventilation, 229 (90.15%) were requiring supplemental oxygen only (with or without non-invasive ventilation), and 19 (7.48%) were receiving neither. The time to clinical improvement was not significantly different between the groups: median of 9 days in the treatment group and 7 days in the control group (HR: 0.845; 95% CI 0.617-1.157; p-value = 0.29). The 28-day mortality was not significantly different between the groups (7.63% treatment) vs. (10.32% control); p-value = 0.45. The most prevalent adverse events were headache, elevation in ALT, and the prolonged QTc interval in the treatment group.
CONCLUSION


The combination of favipiravir and hydroxychloroquine did not result in a statistically significant clinical benefit in patients with moderate-to-severe COVID-19.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov (NCT04392973).",2021,The 28-day mortality was not significantly different between the groups (7.63% treatment) vs. (10.32% control); p-value = 0.45. ,"['Patients with Moderate to Severe COVID-19 (FACCT Trial', 'patients with coronavirus disease 2019 (COVID-19', 'The mean age was 52 (±\u200913)\xa0years, and 103 (41%) were women', 'From May 2020 to Jan 2021, 254 patients were enrolled; 129 were assigned to standard of care and 125 to the treatment', 'Eligible patients were adults with moderate-to-severe COVID-19 defined as oxygen saturation (SaO 2 ) of\u2009≤\u200994% while breathing ambient air or significant clinical symptoms with chest x-ray changes requiring hospital admission', 'patients with moderate-to-severe COVID-19']","['Favipiravir and Hydroxychloroquine Combination Therapy', 'favipiravir and hydroxychloroquine combination', 'favipiravir and hydroxychloroquine', 'standard care (control group) or standard care plus favipiravir and hydroxychloroquine']","['time to clinical improvement', 'time to clinical improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital within 14\xa0days', '28-day mortality', 'invasive mechanical ventilation', 'headache, elevation in ALT, and the prolonged QTc interval']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",254.0,0.169796,The 28-day mortality was not significantly different between the groups (7.63% treatment) vs. (10.32% control); p-value = 0.45. ,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bosaeed', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia. bosaeedmo@ngha.med.sa.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alharbi', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hadeel', 'Initials': 'H', 'LastName': 'Altayib', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia.'}, {'ForeName': 'Hawra', 'Initials': 'H', 'LastName': 'Albayat', 'Affiliation': 'Imam Abdulrahman Alfaisal Hospital, Riyadh, Saudi Arabia.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Alharbi', 'Affiliation': 'Department of Infectious Diseases, King Abdul Aziz Hospital, Makkah, Saudi Arabia.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Ghalilah', 'Affiliation': 'Department of Infectious Diseases, King Salman Medical City, Madinah, Saudi Arabia.'}, {'ForeName': 'Abdulmajid', 'Initials': 'A', 'LastName': 'Al Arfaj', 'Affiliation': 'King Abdulaziz Hospital- Ministry of National Guard Health Affairs, Al Ahsa, Saudi Arabia.'}, {'ForeName': 'Jumana', 'Initials': 'J', 'LastName': 'AlJishi', 'Affiliation': 'Internal Medicine Department, Qatif Central Hospital, Al Qatif, Eastern Province, Saudi Arabia.'}, {'ForeName': 'Abdullatif', 'Initials': 'A', 'LastName': 'Alarfaj', 'Affiliation': 'Imam Abdulrahman Al Faisal Hospital- Ministry of National Guard Health Affairs, Dammam, Saudi Arabia.'}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Alqahtani', 'Affiliation': 'Pharmaceutical Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Badriah M', 'Initials': 'BM', 'LastName': 'Almutairi', 'Affiliation': 'King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Manar', 'Initials': 'M', 'LastName': 'Almaghaslah', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nawaf M', 'Initials': 'NM', 'LastName': 'Alyahya', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Bawazir', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Saud', 'Initials': 'S', 'LastName': 'AlEisa', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Alsaedy', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abderrezak', 'Initials': 'A', 'LastName': 'Bouchama', 'Affiliation': 'King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Malak', 'Initials': 'M', 'LastName': 'Alharbi', 'Affiliation': 'Department of Infectious Diseases, King Salman Medical City, Madinah, Saudi Arabia.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'AlShamrani', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Al Johani', 'Affiliation': 'King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Majed', 'Initials': 'M', 'LastName': 'Aljeraisy', 'Affiliation': 'King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alzahrani', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia.'}, {'ForeName': 'Abdulhakeem O', 'Initials': 'AO', 'LastName': 'Althaqafi', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Almarhabi', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia.'}, {'ForeName': 'Athari', 'Initials': 'A', 'LastName': 'Alotaibi', 'Affiliation': 'Department of Research and Studies, Ministry of Health, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Alqahtani', 'Affiliation': 'Riyadh 1st Health Cluster-Ministry of Health, Riyadh, Saudi Arabia.'}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Omar S', 'Initials': 'OS', 'LastName': 'Aldibasi', 'Affiliation': 'King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alaskar', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}]",Infectious diseases and therapy,['10.1007/s40121-021-00496-6']
953,34319514,Randomized double-blind placebo-controlled trial of hydrogen inhalation for Parkinson's disease: a pilot study.,"BACKGROUND


Oxidative stress is involved in the progression of Parkinson's disease (PD). Recent studies have confirmed that molecular hydrogen (H 2 ) functions as a highly effective antioxidant in animal models of PD. A placebo-controlled, randomized, double-blind, parallel-group clinical pilot study was conducted to assess the efficacy of hydrogen gas inhalation in Japanese patients with PD on treatment with levodopa.
METHODS


Twenty participants fulfilling the Movement Disorder Society criteria were enrolled. Participants inhaled 6.5 (0.1) vol% hydrogen gas in 2 L/min of mixed air or placebo air for 16 weeks, twice a day for 1 h.
RESULTS


Five participants were excluded due to deviation from the protocol of the total duration of inhalation < 112 h. No significant differences were seen in the change in the total Movement Disorder Society Unified Parkinson's Disease Rating Scale score from baseline to the 16 th  week between the group that inhaled hydrogen gas and the group that inhaled placebo air (Mann-Whitney U test, p > 0.05). No adverse events were seen. The compliance to the protocol-based duration of inhalation time in all participants decreased with the elderly participants, the higher daily dose of levodopa, and the higher PDQ-39 items on emotions (n = 20, p < 0.05).
CONCLUSION


This pilot study revealed that the inhalation of molecular hydrogen gas was safe, but did not show any beneficial effects in patients with PD.
TRIAL REGISTRATION


UMIN ID: 000,039,217 (October 6, 2018).",2021,"No significant differences were seen in the change in the total Movement Disorder Society Unified Parkinson's Disease Rating Scale score from baseline to the 16 th  week between the group that inhaled hydrogen gas and the group that inhaled placebo air (Mann-Whitney U test, p > 0.05).","['Five participants were excluded due to deviation from the protocol of the total duration of inhalation\u2009<\u2009112\xa0h', 'Japanese patients with PD on treatment with levodopa', 'Twenty participants fulfilling the Movement Disorder Society criteria were enrolled', 'patients with PD', 'Participants inhaled 6.5 (0.1', ""Parkinson's disease""]","['levodopa', 'UMIN ID', 'hydrogen gas inhalation', 'hydrogen inhalation', 'inhaled placebo', 'vol% hydrogen gas in 2 L/min of mixed air or placebo', 'placebo']","[""total Movement Disorder Society Unified Parkinson's Disease Rating Scale score"", 'adverse events', 'compliance to the protocol-based duration of inhalation time']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C4517420', 'cui_str': '0.1'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0991573', 'cui_str': 'Gas for inhalation'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",5.0,0.769184,"No significant differences were seen in the change in the total Movement Disorder Society Unified Parkinson's Disease Rating Scale score from baseline to the 16 th  week between the group that inhaled hydrogen gas and the group that inhaled placebo air (Mann-Whitney U test, p > 0.05).","[{'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Yoritaka', 'Affiliation': 'Department of Neurology, Juntendo University Koshigaya Hospital, Fukuroyama 560, Koshigayashi, Saitama, 343-0032, Japan. aryori@juntendo.ac.jp.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Pharmacology, Juntendo University Koshigaya Hospital, Saitama, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Neurology, Juntendo University Koshigaya Hospital, Fukuroyama 560, Koshigayashi, Saitama, 343-0032, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Saiki', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan. nhattori@juntendo.ac.jp.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-021-05489-4']
954,34319506,Impact of Low Frequency Electro-acupuncture on Glucose and Lipid Metabolism in Unmarried PCOS Women: A Randomized Controlled Trial.,"OBJECTIVE


To explore the effect of electro-acupuncture (EA) on glucose and lipid metabolism in unmarried patients with polycystic ovary syndrome (PCOS).
METHODS


Fifty-four PCOS patients were equally randomized into true acupuncture group and sham acupuncture group (control) for totally 16 weeks of treatment by random method with a computerized randomization program. Patients in true acupuncture group accepted traditional acupuncture methods with EA and two sets of acupoint groups were used alternatively. The first set consisted of Zhongji (CV 3), Qihai (CV 6), Guilai (ST 29), Sanyinjiao (SP 6), Yinlingquan (SP 9), Hegu (LI4) and Baihui (GV 20), and the second set consisted of Tianshu (ST 25), ST 29, CV 3, CV 6, SP 6, Taichong (LR 3), Neiguan (PC) 6 and GV 20. Patients in the sham acupuncture group accepted shallow acupuncture methods through EA without electricity at 4 non-meridian points in each shoulder and upper arm. Outcome measures included body mass index (BMI), waist-hip-ratio (WHR), oral glucose tolerance test (OGTT), insulin release test, glucose and lipid metabolism indicators such as total cholesterol (TC), triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol, adiponectin, leptin, visfatin, resistin, and interleukin (IL-6).
RESULTS


Twenty-six subjects in the true acupuncture group and 20 subjects in the sham group completed the clinical trial. After 16 weeks of treatment, no significant difference in the outcome measures were observed between the two groups (P>0.05). However, as compared with baseline data, a reduction in weight, BMI, hipline, WHR, fasting glucose, homeostatic model assessment of insulin sensitivity, visfatin and HDL-C, and an increase in resistin and IL-6 were observed in the true acupuncture group (P<0.05). In addition, a reduction in visfatin and an increase in TC were also observed in the sham group (P<0.05).
CONCLUSIONS


Acupuncture may have a beneficial effect in the treatment of PCOS by improving glucose and lipid metabolism. Moreover, the sham acupuncture may be not completely ineffective. Sham acupuncture may improve some of the aspects of the glucose and lipid metabolism of PCOS patients through a placebo effect. (Registration Nos. ChiCTR-TRC-12002529 and NCT01812161).",2021,"After 16 weeks of treatment, no significant difference in the outcome measures were observed between the two groups (P>0.05).","['Unmarried PCOS Women', 'Twenty-six subjects in the true acupuncture group and 20 subjects in the sham group completed the clinical trial', 'unmarried patients with polycystic ovary syndrome (PCOS', 'Fifty-four PCOS patients']","['acupuncture group and sham acupuncture group (control) for totally 16 weeks of treatment by random method with a computerized randomization program', 'sham acupuncture', 'Acupuncture', 'Sham acupuncture', 'electro-acupuncture (EA', 'Low Frequency Electro-acupuncture', 'Zhongji (CV 3), Qihai (CV 6), Guilai (ST 29), Sanyinjiao (SP 6), Yinlingquan (SP 9), Hegu (LI4) and Baihui (GV 20']","['reduction in visfatin', 'glucose and lipid metabolism', 'body mass index (BMI), waist-hip-ratio (WHR), oral glucose tolerance test (OGTT), insulin release test, glucose and lipid metabolism indicators such as total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), adiponectin, leptin, visfatin, resistin, and interleukin (IL-6', 'TC', 'Glucose and Lipid Metabolism', 'weight, BMI, hipline, WHR, fasting glucose, homeostatic model assessment of insulin sensitivity, visfatin and HDL-C, and an increase in resistin and IL-6']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517807', 'cui_str': '54'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0626533', 'cui_str': 'SP 6'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0068707', 'cui_str': 'Nicotinamide phosphoribosyltransferase'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",54.0,0.191905,"After 16 weeks of treatment, no significant difference in the outcome measures were observed between the two groups (P>0.05).","[{'ForeName': 'Hao-Xu', 'Initials': 'HX', 'LastName': 'Dong', 'Affiliation': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Center of Wuhan Puren Hospital, Affiliated Hospital of Wuhan University of Science and Technology, Wuhan, 430081, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Xiao-Ke', 'Initials': 'XK', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, 50040, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Acupuncture and Moxibustion, East Hospital, Tongji University, Shanghai, 200120, China.'}, {'ForeName': 'Zhong-Ming', 'Initials': 'ZM', 'LastName': 'Zhou', 'Affiliation': 'Department of Obstetrics and Gynecology, Hubei University of Traditional Chinese Medicine, Wuhan, 430060, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yi', 'Affiliation': 'Department of Rehabilitation Center of Wuhan Puren Hospital, Affiliated Hospital of Wuhan University of Science and Technology, Wuhan, 430081, China.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Huang', 'Affiliation': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, 430030, China. hdmjcr@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-3482-z']
955,34318438,"Opioid-Free Recovery After Hernia Repair with HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting: A Randomized, Open-Label Study.","INTRODUCTION


Helping Opioid Prescription Elimination (HOPE) is a project designed to provide surgeons with practical, real-world solutions to effectively manage postoperative pain and eliminate the need for opioids using HTX-011 (extended-release bupivacaine/low-dose meloxicam). In phase 3 herniorrhaphy and bunionectomy studies, HTX-011 without multimodal analgesia (MMA) was superior to bupivacaine hydrochloride in reducing pain and opioid consumption. Here, we examine the HOPE Hernia-1 study, which was designed to compare alternating ibuprofen/acetaminophen with concurrent use as part of an HTX-011-based non-opioid MMA regimen in patients undergoing herniorrhaphy and to evaluate the effectiveness of a personalized opioid prescription algorithm.
METHODS


Patients undergoing outpatient open inguinal herniorrhaphy with intraoperative administration of HTX-011 (300 mg bupivacaine/9 mg meloxicam) were randomly assigned to receive a scheduled oral regimen of ibuprofen plus acetaminophen, either taken together every 6 hours or alternating every 3 hours, for 5 days following surgery, while awake. Based on the opioid prescription algorithm evaluated here, patients could receive an oxycodone prescription upon discharge only if they had a numeric rating scale pain score of ≥ 6 at discharge and/or had received a postoperative rescue opioid.
RESULTS


The majority of patients did not require an opioid prescription through 2 weeks following surgery, and this was similar between cohorts (alternating MMA, 89.1%; concurrent MMA, 93.6%). Patient satisfaction was high for both regimens, and 95% of patients had an opioid-free recovery. No patient discharged without a prescription called back to request one. Treatment was well tolerated, without evidence of nonsteroidal anti-inflammatory drug-related toxicity.
CONCLUSIONS


HTX-011, used with over-the-counter products ibuprofen/acetaminophen and personalized opioid prescription algorithm in a real-world environment, has the potential to reduce opioid use and opioid prescriptions after herniorrhaphy without compromising patient satisfaction.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03237481.",2021,"Treatment was well tolerated, without evidence of nonsteroidal anti-inflammatory drug-related toxicity.
","['patients undergoing herniorrhaphy', 'Patients undergoing outpatient open inguinal herniorrhaphy with intraoperative administration of']","['bupivacaine hydrochloride', 'ibuprofen/acetaminophen', 'ibuprofen plus acetaminophen', 'HTX-011', 'HTX-011 without multimodal analgesia (MMA', 'oxycodone prescription', 'bupivacaine/9', 'Opioid-Free Recovery', 'mg meloxicam', 'HTX-011-based non-opioid MMA regimen']","['pain and opioid consumption', 'numeric rating scale pain score', 'Patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",,0.194301,"Treatment was well tolerated, without evidence of nonsteroidal anti-inflammatory drug-related toxicity.
","[{'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Minkowitz', 'Affiliation': 'HD Research Group, 4801 Bissonnet St, Bellaire, TX, 77401, USA. harold@minkowitzmd.com.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Soto', 'Affiliation': 'Beaumont Health System, 3601 W 13 Mile Rd, Royal Oak, MI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fanikos', 'Affiliation': ""Brigham and Women's Hospital, 75 Francis St, Boston, MA, 02115, USA.""}, {'ForeName': 'Gregory B', 'Initials': 'GB', 'LastName': 'Hammer', 'Affiliation': 'Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA.'}, {'ForeName': 'Neel', 'Initials': 'N', 'LastName': 'Mehta', 'Affiliation': 'Weill Cornell Pain Medicine Center, 1300 York Avenue, New York, NY, 10065, USA.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Heron Therapeutics, Inc., 4242 Campus Point Court Suite 200, San Diego, CA, 92121, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Redan', 'Affiliation': 'AdventHealth Celebration, 400 Celebration Place, Celebration, FL, 34747, USA.'}]",Pain and therapy,['10.1007/s40122-021-00289-2']
956,34316017,Molecular landscape and prognostic impact of FLT3-ITD insertion site in acute myeloid leukemia: RATIFY study results.,"In acute myeloid leukemia (AML) internal tandem duplications of the FLT3 gene (FLT3-ITD) are associated with poor prognosis. Retrospectively, we investigated the prognostic and predictive impact of FLT3-ITD insertion site (IS) in 452 patients randomized within the RATIFY trial, which evaluated midostaurin additionally to intensive chemotherapy. Next-generation sequencing identified 908 ITDs, with 643 IS in the juxtamembrane domain (JMD) and 265 IS in the tyrosine kinase domain-1 (TKD1). According to IS, patients were categorized as JMDsole (n = 251, 55%), JMD and TKD1 (JMD/TKD1; n = 117, 26%), and TKD1sole (n = 84, 19%). While clinical variables did not differ among the 3 groups, NPM1 mutation was correlated with JMDsole (P = 0.028). Overall survival (OS) differed significantly, with estimated 4-year OS probabilities of 0.44, 0.50, and 0.30 for JMDsole, JMD/TKD1, and TKD1sole, respectively (P = 0.032). Multivariate (cause-specific) Cox models for OS and cumulative incidence of relapse using allogeneic hematopoietic cell transplantation (HCT) in first complete remission as a time-dependent variable identified TKD1sole as unfavorable and HCT as favorable factors. In addition, Midostaurin exerted a significant benefit only for JMDsole. Our results confirm the distinct molecular heterogeneity of FLT3-ITD and the negative prognostic impact of TKD1 IS in AML that was not overcome by midostaurin.",2021,"Overall survival (OS) differed significantly, with estimated 4-year OS probabilities of 0.44, 0.50, and 0.30 for JMDsole, JMD/TKD1, and TKD1sole, respectively (P = 0.032).","['acute myeloid leukemia', '452 patients randomized within the RATIFY trial, which evaluated midostaurin additionally to intensive chemotherapy']","['Midostaurin', 'FLT3-ITD insertion site (IS', 'FLT3-ITD insertion site', 'allogeneic hematopoietic cell transplantation (HCT']","['NPM1 mutation', 'Overall survival (OS']","[{'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0526371', 'cui_str': 'midostaurin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0526371', 'cui_str': 'midostaurin'}, {'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0449682', 'cui_str': 'Site of insertion'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0069141', 'cui_str': 'nucleophosmin'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",452.0,0.0713283,"Overall survival (OS) differed significantly, with estimated 4-year OS probabilities of 0.44, 0.50, and 0.30 for JMDsole, JMD/TKD1, and TKD1sole, respectively (P = 0.032).","[{'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Rücker', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Novartis Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Luck', 'Affiliation': 'Department of Hematology, Oncology and Tumor Immunology, Charité University, Berlin, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Krzykalla', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Insa', 'Initials': 'I', 'LastName': 'Gathmann', 'Affiliation': 'Novartis Pharmaceuticals, Basel, Switzerland.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Voso', 'Affiliation': 'Department of Biomedicine and Prevention, Università di Roma ""Tor Vergata"", Rome, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'Department of Biomedicine and Prevention, Università di Roma ""Tor Vergata"", Rome, Italy.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Prior', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brandwein', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Bruno C', 'Initials': 'BC', 'LastName': 'Medeiros', 'Affiliation': 'Division of Hematology, Stanford Comprehensive Cancer Center, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Savoie', 'Affiliation': 'University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sierra', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu i Sant Pau and Jose Carreras Leukemia Research Institute, Autonomus University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Pallaud', 'Affiliation': 'Novartis Pharmaceuticals, Basel, Switzerland.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Sanz', 'Affiliation': 'Hospital Universitario la Fe, Hematology Department, Department of Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Joop H', 'Initials': 'JH', 'LastName': 'Jansen', 'Affiliation': 'Radboud Institute Molecular Studies, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'Hematology and Oncology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fischer', 'Affiliation': 'Department of Hematology and Oncology, Center of Internal Medicine, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bullinger', 'Affiliation': 'Department of Hematology, Oncology and Tumor Immunology, Charité University, Berlin, Germany.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'Department of Medicine and Comprehensive Cancer Center, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Clara D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA, USA.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden, Germany.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany. konstanze.doehner@uniklinik-ulm.de.'}]",Leukemia,['10.1038/s41375-021-01323-0']
957,34270843,Efficacy of da Vinci robot-assisted lymph node surgery than conventional axillary lymph node dissection in breast cancer - A comparative study.,"BACKGROUND


da Vinci robot-assisted axillary lymph node dissection (dVALND) can be a minimally invasive technique to minimize post-operative complications.
OBJECTIVE


To explore the clinical efficacy of dVALND in breast cancer (BC) patients for mitigating the postoperative complications than conventional ALND.
METHODS


Total 60 female patients with BC were admitted to our hospitals since September 2018, and these patients segregated into two groups of 30 patients each. Modified radical mastectomy for BC was performed to the patients in both groups. In Group 1 (control group), ALND was performed using conventional mode of axillary lymph node surgery. In Group 2 (Test group), the dVALND was performed using da Vinci robot-assisted surgery. Wound healing, aesthetic effect and patient's satisfaction were evaluated after conventional method and dVALND.
RESULTS


Postoperative complications viz., wound infection (1/30 (3.33%), p < 0.05), fat necrosis (3/30 (10%), p < 0.05) and lymphedema of upper limbs (2/30 (6.67%), p < 0.05) were observed in dVALND than conventional surgery. Local recurrence or metastasis was minimized and overall aesthetic effect not observed during follow-up.
CONCLUSION


dVALND improved the overall patient's quality of life by mitigating postoperative complications than ALND.",2021,", wound infection (1/30 (3.33%), p < 0.05), fat necrosis (3/30 (10%), p < 0.05) and lymphedema of upper limbs (2/30 (6.67%), p < 0.05) were observed in dVALND than conventional surgery.","['Total 60 female patients with BC were admitted to our hospitals since September 2018, and these patients segregated into two groups of 30 patients each', 'breast cancer (BC) patients']","['ALND', 'Modified radical mastectomy', 'conventional axillary lymph node dissection', 'da Vinci robot-assisted lymph node surgery', 'dVALND was performed using da Vinci robot-assisted surgery', 'dVALND', 'da Vinci robot-assisted axillary lymph node dissection (dVALND']","['wound infection', 'fat necrosis', 'Local recurrence or metastasis', ""Wound healing, aesthetic effect and patient's satisfaction"", 'lymphedema of upper limbs', ""overall patient's quality of life""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C1457900', 'cui_str': 'Each'}]","[{'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0015668', 'cui_str': 'Fat necrosis'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C3265926', 'cui_str': 'Lymphedema of upper limb'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0784184,", wound infection (1/30 (3.33%), p < 0.05), fat necrosis (3/30 (10%), p < 0.05) and lymphedema of upper limbs (2/30 (6.67%), p < 0.05) were observed in dVALND than conventional surgery.","[{'ForeName': 'Kuo', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Breast Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Narasimha', 'Initials': 'N', 'LastName': 'M Beeraka', 'Affiliation': 'I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Igor V', 'Initials': 'IV', 'LastName': 'Reshetov', 'Affiliation': 'I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Vladimir N', 'Initials': 'VN', 'LastName': 'Nikolenko', 'Affiliation': 'I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Mikhail Y', 'Initials': 'MY', 'LastName': 'Sinelnikov', 'Affiliation': 'I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Liudmila M', 'Initials': 'LM', 'LastName': 'Mikhaleva', 'Affiliation': 'Research Institute of Human Morphology, Moscow, Russian Federation.'}]",The international journal of medical robotics + computer assisted surgery : MRCAS,['10.1002/rcs.2307']
958,34323384,A modified urinary catheterisation technique to reduce urine leakage: A prospective randomised study.,"BACKGROUND


Long-term indwelling catheters assist people who are unable to use another bladder management method. However, urine leakage is a common problem with an indwelling urinary catheter. This study aims to determine whether a modified catheterisation technique would reduce urine leakage incidence.
METHODS


Participants were randomly divided into conventional or modified catheterisation groups. In the modified technique group, the volume of fluid that needed to be injected into the balloon to obtain a suitable catheter front-end curvature (120-145°) was measured before catheterisation. Baseline characteristics and first-time success rates and procedure durations were similar between groups.
RESULTS


There were 30 patients in each group. Compared with conventional catheterisation, the modified catheterisation group had smaller residual urine volume (median 11 mL Vs. 30.5 mL, p<0.001) and more leakage-free days (30 days Vs. 10 days, p<0.001). Leakage-free survival was longer in the modified catheterisation group (p<0.001). The residual urine volume (>17 vs ≤17 ml (median); incident rate ratio (IRR), 28.710; 95%CI, 4.114-200.331; p=0.001) was independently associated with urine leakage.
CONCLUSIONS


The modified catheterisation technique may reduce the incidence of urine leakage.",2021,Leakage-free survival was longer in the modified catheterisation group (p<0.001).,['Participants'],"['conventional catheterisation', 'conventional or modified catheterisation', 'modified urinary catheterisation technique', 'modified catheterisation technique']","['residual urine volume', 'Leakage-free survival', 'incidence of urine leakage', 'urine leakage', 'urine leakage incidence']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042019', 'cui_str': 'Catheterization, Urinary'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0429774', 'cui_str': 'Residual urine volume'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0152245', 'cui_str': 'Extravasation of urine'}]",,0.0935293,Leakage-free survival was longer in the modified catheterisation group (p<0.001).,"[{'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'Department of Cardiothoracic Surgery, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Yulian', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiothoracic Surgery, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Weiyang', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': 'Department of Neurosurgery, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Guihong', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Ultrasonography, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Chenguang', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Intervention Center, Enze Medical Center/Hospital, Taizhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Nursing, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'VIP Clinic, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthopedics, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Neurosurgery, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiothoracic Surgery, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}]",International journal of older people nursing,['10.1111/opn.12405']
959,34340839,Effect of erector spinae plane block on the postoperative quality of recovery after laparoscopic cholecystectomy: a prospective double-blind study.,"BACKGROUND


Laparoscopic cholecystectomy is a common surgical procedure that frequently results in substantial postoperative pain. Erector spinae plane block (ESPB) has been shown to have beneficial postoperative analgesic effects when used as a part of multimodal analgesia. The aim of this study was to determine whether ESPB improves postoperative recovery quality in patients undergoing laparoscopic cholecystectomy. Evaluation of the effects of ESPB on postoperative pain, opioid consumption, and nausea and vomiting was the secondary objective.
METHODS


In this prospective double-blind study, 82 patients undergoing laparoscopic cholecystectomy were randomised into one of two groups: a standard multimodal analgesic regimen in Group N (control) or an ESPB was performed in Group E. Preoperative and postoperative recovery quality was measured using the 40-item quality of recovery (QoR-40) questionnaire; postoperative pain was evaluated using the numerical rating scale scores.
RESULTS


Postoperative mean (standard deviation) QoR-40 scores were higher in Group E (181 [7.3]) than in Group N (167 [11.4]); P<0.01. With repeated measures, a significant effect of group and time was demonstrated for the global QoR-40 score, P<0.01, indicating better quality of recovery in Group E. Pain scores were significantly lower in Group E than in Group N, both during resting and motion at T1-T8 times (P<0.01 at each time). The total amount of tramadol consumed in the first 24 h was lower in Group E [median 0 mg, inter-quartile range (IQR) (0-140)], than in Group N [median 180 mg, IQR (150-240); P<0.01].
CONCLUSIONS


ESPB improved postoperative quality of recovery in patients undergoing laparoscopic cholecystectomy. Moreover, ESPB reduced pain scores and cumulative opioid consumption.
CLINICAL TRIAL REGISTRATION


NCT04112394.",2021,QoR-40 scores were higher in Group E (181 [7.3]) than in Group N (167 [11.4]); P<0.01.,"['82 patients undergoing', 'patients undergoing laparoscopic cholecystectomy']","['ESPB', 'Laparoscopic cholecystectomy', 'standard multimodal analgesic regimen in Group N (control) or an ESPB', 'Erector spinae plane block (ESPB', 'laparoscopic cholecystectomy', 'erector spinae plane block']","['40-item quality of recovery (QoR-40) questionnaire; postoperative pain', 'global QoR-40 score', 'postoperative pain, opioid consumption, and nausea and vomiting', 'ESPB reduced pain scores and cumulative opioid consumption', 'QoR-40 scores', 'numerical rating scale scores', 'postoperative quality of recovery', 'Postoperative mean (standard deviation', 'quality of recovery in Group E. Pain scores', 'postoperative recovery quality', 'total amount of tramadol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0441848', 'cui_str': 'Group N'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",82.0,0.101684,QoR-40 scores were higher in Group E (181 [7.3]) than in Group N (167 [11.4]); P<0.01.,"[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Canıtez', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Abdulkadir Yuksel City Hospital, Gaziantep, Turkey.'}, {'ForeName': 'Betul', 'Initials': 'B', 'LastName': 'Kozanhan', 'Affiliation': 'Department of Anaesthesiology and Reanimation, University of Health Sciences, Konya Education and Research Hospital, Konya, Turkey. Electronic address: betulkozanhan@gmail.com.'}, {'ForeName': 'Nergis', 'Initials': 'N', 'LastName': 'Aksoy', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Konya Education and Research Hospital, Konya, Turkey.'}, {'ForeName': 'Munise', 'Initials': 'M', 'LastName': 'Yildiz', 'Affiliation': 'Department of Anaesthesiology and Reanimation, University of Health Sciences, Konya Education and Research Hospital, Konya, Turkey.'}, {'ForeName': 'Mahmut S', 'Initials': 'MS', 'LastName': 'Tutar', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Konya Numune State Hospital, Konya, Turkey.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.06.030']
960,34346510,Delayed surgical resection of primary left-sided obstructing colon cancer is associated with improved short- and long-term outcomes.,"BACKGROUND AND OBJECTIVES


It is unclear what time interval is optimal between presentation and surgical resection of left-sided obstructive colon cancer (LSOCC). This study aims to determine whether a time interval beyond 4 weeks is associated with a better outcome.
MATERIALS AND METHODS


Consecutive patients who underwent surgical resection of LSOCC between January 2010 and December 2019 were collected from a prospective database. Patients were divided into three groups: (1) Emergency resection (ER group), (2) surgery in less than 4 weeks (early group), and (3) surgery beyond 4 weeks (late group).
RESULTS


The ER group consisted of 74 (44.0%), the early group of 38 (22.6%), and the late group of 56 (33.3%) patients. Ninety-day mortality was lower in the Late group than in the ER group and the early group (1.8% vs. 12.2%, p = 0.029 vs. 15.3%, p = 0.011). In the late group 5-year recurrence-free survival was better than in the early group (82.1% vs. 63.2%, p = 0.039) and 5-year overall survival (OS) was better than in the ER group (75% vs. 51.4%, p = 0.021). Definitive surgical resection beyond 4 weeks was an independent prognostic factor for OS (Hazard ratio: 0.402, 95% CI: 0.204-0.793, p = 0.009).
CONCLUSION


In this study surgical resection beyond 4 weeks after presentation seems to have a better short- and long-term outcome for LSOCC.",2021,In this study surgical resection beyond 4 weeks after presentation seems to have a better short- and long-term outcome for LSOCC.,['Consecutive patients who underwent surgical resection of LSOCC between January 2010 and December 2019 were collected from a prospective database'],"['Emergency resection (ER group), (2) surgery in less than 4 weeks (early group), and (3) surgery beyond 4 weeks (late group']","['5-year overall survival (OS', 'Ninety-day mortality', '5-year recurrence-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",,0.0984574,In this study surgical resection beyond 4 weeks after presentation seems to have a better short- and long-term outcome for LSOCC.,"[{'ForeName': 'Marnix A J', 'Initials': 'MAJ', 'LastName': 'de Roos', 'Affiliation': 'Department of Gastrointestinal Surgery and Surgical Oncology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Niek', 'Initials': 'N', 'LastName': 'Hugen', 'Affiliation': 'Department of Gastrointestinal Surgery and Surgical Oncology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Hazebroek', 'Affiliation': 'Department of Gastrointestinal Surgery and Surgical Oncology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Ernst J', 'Initials': 'EJ', 'LastName': 'Spillenaar Bilgen', 'Affiliation': 'Department of Gastrointestinal Surgery and Surgical Oncology, Rijnstate Hospital, Arnhem, The Netherlands.'}]",Journal of surgical oncology,['10.1002/jso.26632']
961,34344638,"Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE.","BACKGROUND


In the phase 3 ALCYONE study, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) versus bortezomib/melphalan/prednisone (VMP) significantly improved progression-free survival (PFS) and overall survival (OS) in transplant-ineligible, newly diagnosed multiple myeloma (NDMM) patients. We present a subgroup analysis of ALCYONE by patient frailty status.
PATIENTS AND METHODS


Frailty assessment was performed retrospectively using age, Charlson comorbidity index, and baseline Eastern Cooperative Oncology Group performance status score. Patients were classified as fit (0), intermediate (1), or frail (≥2); a nonfrail category combined fit and intermediate patients.
RESULTS


Among randomized patients (D-VMP, n = 350; VMP, n = 356), 391 (55.4%) were nonfrail (D-VMP, 187 [53.4%]; VMP, 204 [57.3%]) and 315 (44.6%) were frail (163 [46.6%]; 152 [42.7%]). After 40.1-months median follow-up, nonfrail patients had longer PFS and OS than frail patients, but benefits of D-VMP versus VMP were maintained across subgroups: PFS nonfrail (median, 45.7 vs. 19.1 months; hazard ratio [HR], 0.36; P < .0001), frail (32.9 vs. 19.5 months; HR, 0.51; P < .0001); OS nonfrail (36-month rate, 83.6% vs. 74.5%), frail (71.4% vs. 59.0%). Improved greater than or equal to complete response and minimal residual disease (10 - 5 )-negativity rates were observed for D-VMP versus VMP across subgroups. The 2 most common grade 3/4 treatment-emergent adverse events were neutropenia (nonfrail: 39.2% [D-VMP] and 42.4% [VMP]; frail: 41.3% and 34.4%) and thrombocytopenia (nonfrail: 32.8% and 36.9%; frail: 36.9% and 39.1%).
CONCLUSION


Our findings support the clinical benefit of D-VMP in transplant-ineligible NDMM patients enrolled in ALCYONE, regardless of frailty status.",2021,"After 40.1-months median follow-up, nonfrail patients had longer PFS and OS than frail patients, but benefits of D-VMP versus VMP were maintained across subgroups: PFS nonfrail (median, 45.7 vs. 19.1 months; hazard ratio [HR], 0.36; P < .0001), frail (32.9 vs. 19.5 months; HR, 0.51; P < .0001); OS nonfrail (36-month rate, 83.6% vs. 74.5%), frail (71.4% vs. 59.0%).","['transplant-ineligible, newly diagnosed multiple myeloma (NDMM) patients', 'Patients were classified as fit (0), intermediate (1), or frail (≥2); a nonfrail category combined fit and intermediate patients', 'Transplant-Ineligible Newly Diagnosed Multiple Myeloma', 'transplant-ineligible NDMM patients', 'Frailty assessment was performed retrospectively using age, Charlson comorbidity index, and baseline Eastern Cooperative Oncology Group performance status score']","['bortezomib/melphalan/prednisone (D-VMP) versus bortezomib/melphalan/prednisone (VMP', 'Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone']","['OS nonfrail', 'neutropenia', 'longer PFS and OS', 'progression-free survival (PFS) and overall survival (OS', 'thrombocytopenia', 'complete response and minimal residual disease (10 - 5 )-negativity rates']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0284383', 'cui_str': 'AP protocol 2'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}]",,0.148353,"After 40.1-months median follow-up, nonfrail patients had longer PFS and OS than frail patients, but benefits of D-VMP versus VMP were maintained across subgroups: PFS nonfrail (median, 45.7 vs. 19.1 months; hazard ratio [HR], 0.36; P < .0001), frail (32.9 vs. 19.5 months; HR, 0.51; P < .0001); OS nonfrail (36-month rate, 83.6% vs. 74.5%), frail (71.4% vs. 59.0%).","[{'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'University Hospital of Salamanca/IBSAL, Cancer Research Center IBMCC (USAL-CSIC), Salamanca, Spain. Electronic address: mvmateos@usal.es.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università degli Studi, Bologna, Italy.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Japanese Red Cross Medical Center, Department of Hematology, Tokyo, Japan.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Knop', 'Affiliation': 'Würzburg University Medical Center, Würzburg, Germany.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Doyen', 'Affiliation': 'Université Catholique de Louvain, Yvoir, Belgium.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Lucio', 'Affiliation': 'Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Nagy', 'Affiliation': 'Semmelweis Egyetem, Budapest, Hungary.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'University Hospital Brno, Brno-Bohunice-Brno-Starý Lískovec, Czech Republic.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention in Chorzów, Faculty of Health Sciences in Bytom, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Crepaldi', 'Affiliation': 'Clinica de Tratamento E, Cuiaba, Brazil.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Università degli Studi di Perugia Azienda Ospedaliera ""Santa Maria,"" Terni, Italy.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Campbell', 'Affiliation': 'Andrew Love Cancer Centre, University Hospital Geelong, Geelong, VIC, Australia.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Genadi', 'Initials': 'G', 'LastName': 'Iosava', 'Affiliation': 'Medinvest-Institute of Hematology, Tbilisi, Georgia.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Fujisaki', 'Affiliation': 'Matsuyama Red Cross Hospital, Matsuyama, Japan.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'Leicester Royal Infirmary - Haematology, Leicester, United Kingdom.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku Nagoya, Japan.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bladé', 'Affiliation': ""Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Pei', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ.'}, {'ForeName': 'Rian', 'Initials': 'R', 'LastName': 'Van Rampelbergh', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Anupa', 'Initials': 'A', 'LastName': 'Kudva', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), Instituto de Investigación Sanitaria de Navarra (IDISNA), Pamplona, Navarra, Spain.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2021.06.005']
962,34298547,The effects of a preschool-based intervention for Early Childhood Education and Care teachers in promoting healthy eating and physical activity in young children: A cluster randomised controlled trial.,"The need for excess weight gain prevention in disadvantaged young children is widely recognised. Early Childhood Education and Care teachers are potential key actors in early interventions to prevent overweight and obesity. This study examines the effects of a preschool-based intervention for teachers in promoting healthy eating and physical activity in young children. A cluster randomised controlled trial was conducted at 41 preschools in a deprived area of Amsterdam, The Netherlands. The intervention consisted of 2 programmes that were applied in succession: A Healthy Start and PLAYgrounds for TODdlers. The study period was 9 months. Primary outcomes were assessed via questionnaires and included teachers' knowledge, attitude, food/activity-related practices, and level of confidence in promoting healthy behaviours. Secondary outcomes in this study were teachers' and children's BMI (z-score), body composition, dietary intake and physical activity level. Intention-to-treat analyses were performed using linear mixed models. In total, 115 teachers and 249 children (mean age 3.0 (0.2) years) were included. A positive effect on teachers' knowledge about the Dutch dietary guidelines was found after the programme A Healthy Start (difference = 1.38; 1-sided 95% CL = 0.29; p = 0.02). This effect was not sustained at 9 months (difference = 0.34; 1-sided 95% CL = -0.76; p = 0.31). The overall intervention had a positive effect on 3 of the 5 attitude statements regarding a healthy lifestyle (difference ranged from 0.34 to 0.55) and on the practice scale Activity-related-Modelling (difference = 0.16; 1-sided 95% CL = 0.06; p = 0.01). No intervention effects were observed on food-related practice scales and the level of confidence in promoting healthy behaviours. At this stage, no effects were seen on teachers' and children's BMI (z-score). This study contributes to the professional development of Early Childhood Education and Care teachers and addresses the call for interventions to prevent overweight/obesity and to minimise health inequalities in young children.",2021,The overall intervention had a positive effect on 3 of the 5 attitude statements regarding a healthy lifestyle (difference ranged from 0.34 to 0.55) and on the practice scale Activity-related-Modelling (difference = 0.16; 1-sided 95% CL = 0.06; p = 0.01).,"['young children', 'disadvantaged young children', 'In total, 115 teachers and 249 children (mean age 3.0 (0.2) years) were included', '41 preschools in a deprived area of Amsterdam, The Netherlands']","['preschool-based intervention', '2 programmes that were applied in succession']","['practice scale Activity-related-Modelling', 'healthy lifestyle', ""teachers' and children's BMI (z-score), body composition, dietary intake and physical activity level"", ""via questionnaires and included teachers' knowledge, attitude, food/activity-related practices, and level of confidence in promoting healthy behaviours"", ""teachers' and children's BMI (z-score"", ""teachers' knowledge about the Dutch dietary guidelines"", 'food-related practice scales and the level of confidence in promoting healthy behaviours', 'healthy eating and physical activity']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}]",115.0,0.0352067,The overall intervention had a positive effect on 3 of the 5 attitude statements regarding a healthy lifestyle (difference ranged from 0.34 to 0.55) and on the practice scale Activity-related-Modelling (difference = 0.16; 1-sided 95% CL = 0.06; p = 0.01).,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Toussaint', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Martinette T', 'Initials': 'MT', 'LastName': 'Streppel', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Mul', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Balledux', 'Affiliation': 'Netherlands Youth Institute, Utrecht, The Netherlands.'}, {'ForeName': 'Karen van', 'Initials': 'KV', 'LastName': 'Drongelen', 'Affiliation': 'The Netherlands Nutrition Centre, The Hague, The Netherlands.'}, {'ForeName': 'Mirka', 'Initials': 'M', 'LastName': 'Janssen', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Ruben G', 'Initials': 'RG', 'LastName': 'Fukkink', 'Affiliation': 'Faculty of Child Development and Education, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter J M', 'Initials': 'PJM', 'LastName': 'Weijs', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0255023']
963,34298438,"A randomized, double-blind, placebo-controlled trial of hydrocortisone augmentation of Prolonged Exposure for PTSD in U.S. combat veterans.","OBJECTIVE


Cognitive behavioral therapies such as Prolonged Exposure (PE) are considered first line treatments for posttraumatic stress disorder (PTSD). Nonetheless, many continue to experience significant symptoms following treatment and there is interest in enhancing treatment effectiveness. Glucocorticoid alterations in PTSD are well documented, and these steroids have been shown to enhance extinction learning.
METHODS


Augmentation of PE with the synthetic glucocorticoid hydrocortisone (HCORT) was tested in a randomized, double-blind, placebo-controlled trial in 60 veterans of wars in Iraq or Afghanistan with PTSD (NCT01525680). Participants ingested 30 mg oral HCORT or placebo 30 min prior to exposure sessions.
PRIMARY OUTCOME MEASURE


PTSD severity assessed by the CAPS; secondary outcome measures: self reported PTSD symptoms assessed by the PDS and depression assessed by the BDI; all administered at pretreatment, posttreatment, and 3-month follow up.
RESULTS


Across conditions, there was a robust effect of PE over time. An intent-to-treat analysis showed that HCORT did not measurably improve PTSD symptoms or secondary outcomes. However, exploratory analyses indicated that veterans with mild TBI exposure and current postconcussive symptoms showed a greater reduction in hyperarousal symptoms following PE treatment with HCORT augmentation. Additionally, veterans with higher baseline glucocorticoid sensitivity showed a greater reduction in avoidance symptoms with HCORT augmentation.
CONCLUSIONS


Treatment matching based on cognitive or biological vulnerabilities might lead to greater efficacy of PE with glucocorticoid augmentation.",2021,An intent-to-treat analysis showed that HCORT did not measurably improve PTSD symptoms or secondary outcomes.,"['U.S. combat veterans', 'posttraumatic stress disorder (PTSD', '60 veterans of wars in Iraq or Afghanistan with PTSD (NCT01525680']","['synthetic glucocorticoid hydrocortisone (HCORT', 'HCORT', 'placebo', 'oral HCORT or placebo', 'hydrocortisone']","['avoidance symptoms', 'hyperarousal symptoms', 'PTSD symptoms', 'PTSD symptoms assessed by the PDS and depression assessed by the BDI']","[{'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}]","[{'cui': 'C0017711', 'cui_str': 'Synthetic glucocorticoid'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360554', 'cui_str': 'Hydrocortisone-containing product in oral dose form'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}]",60.0,0.627232,An intent-to-treat analysis showed that HCORT did not measurably improve PTSD symptoms or secondary outcomes.,"[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lehrner', 'Affiliation': 'Mental Health Patient Care Center, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: amy.lehrner@va.gov.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Bierer', 'Affiliation': 'Mental Health Patient Care Center, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Janine D', 'Initials': 'JD', 'LastName': 'Flory', 'Affiliation': 'Mental Health Patient Care Center, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'Bader', 'Affiliation': 'Mental Health Patient Care Center, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Iouri', 'Initials': 'I', 'LastName': 'Makotkine', 'Affiliation': 'Mental Health Patient Care Center, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yehuda', 'Affiliation': 'Mental Health Patient Care Center, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103924']
964,34297895,Recruitment of a multi-site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial.,"INTRODUCTION


Effective strategies to recruit older adults with mild cognitive impairment (MCI) into nonpharmacological intervention trials are lacking.
METHODS


Recruitment for EXERT, a multisite randomized controlled 18-month trial examining the effects of aerobic exercise on cognitive trajectory in adults with amnestic MCI, involved a diverse portfolio of strategies to enroll 296 participants.
RESULTS


Recruitment occurred September 2016 through March 2020 and was initially slow. After mass mailings of 490,323 age- and geo-targeted infographic postcards and brochures, recruitment rates increased substantially, peaking at 16 randomizations/month in early 2020. Mass mailings accounted for 52% of randomized participants, whereas 25% were recruited from memory clinic rosters, electronic health records, and national and local registries. Other sources included news broadcasts, public service announcements (PSA), local advertising, and community presentations.
DISCUSSION


Age- and geo-targeted mass mailing of infographic materials was the most effective approach in recruiting older adults with amnestic MCI into an 18-month exercise trial.",2021,"DISCUSSION


Age- and geo-targeted mass mailing of infographic materials was the most effective approach in recruiting older adults with amnestic MCI into an 18-month exercise trial.","['adults with amnestic MCI, involved a diverse portfolio of strategies to enroll 296 participants', 'older adults with amnestic mild cognitive impairment', 'older adults with mild cognitive impairment (MCI', 'older adults with amnestic MCI']",['aerobic exercise'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]",[],,0.211492,"DISCUSSION


Age- and geo-targeted mass mailing of infographic materials was the most effective approach in recruiting older adults with amnestic MCI into an 18-month exercise trial.","[{'ForeName': 'Aladdin H', 'Initials': 'AH', 'LastName': 'Shadyab', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Andrea Z', 'Initials': 'AZ', 'LastName': 'LaCroix', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Feldman', 'Affiliation': ""Department of Neurosciences, Alzheimer's Disease Cooperative Study, University of California, San Diego, La Jolla, California, USA.""}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'van Dyck', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Ozioma C', 'Initials': 'OC', 'LastName': 'Okonkwo', 'Affiliation': ""School of Medicine and Public Health, Wisconsin Alzheimer's Disease Research Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.""}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Tam', 'Affiliation': 'University of California, Irvine School of Medicine, Irvine, California, USA.'}, {'ForeName': 'J Kaci', 'Initials': 'JK', 'LastName': 'Fairchild', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Welsh-Bohmer', 'Affiliation': ""Department of Neurology, Bryan Alzheimer's Disease Research Center, Duke University School of Medicine, Durham, North Carolina, USA.""}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Matthews', 'Affiliation': ""Department of Neurosciences, Alzheimer's Disease Cooperative Study, University of California, San Diego, La Jolla, California, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bennett', 'Affiliation': ""Department of Neurosciences, Alzheimer's Disease Cooperative Study, University of California, San Diego, La Jolla, California, USA.""}, {'ForeName': 'Alexandre A', 'Initials': 'AA', 'LastName': 'Shadyab', 'Affiliation': ""Department of Neurosciences, Alzheimer's Disease Cooperative Study, University of California, San Diego, La Jolla, California, USA.""}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Schafer', 'Affiliation': ""Department of Neurosciences, Alzheimer's Disease Cooperative Study, University of California, San Diego, La Jolla, California, USA.""}, {'ForeName': 'Rosemary H', 'Initials': 'RH', 'LastName': 'Morrison', 'Affiliation': ""Department of Neurosciences, Alzheimer's Disease Cooperative Study, University of California, San Diego, La Jolla, California, USA.""}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Kipperman', 'Affiliation': ""Department of Neurosciences, Alzheimer's Disease Cooperative Study, University of California, San Diego, La Jolla, California, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': ""Department of Neurosciences, Alzheimer's Disease Cooperative Study, University of California, San Diego, La Jolla, California, USA.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': ""Department of Neurosciences, Alzheimer's Disease Cooperative Study, University of California, San Diego, La Jolla, California, USA.""}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Thomas', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Cotman', 'Affiliation': 'Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Baker', 'Affiliation': 'Department of Internal Medicine-Geriatrics, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12401']
965,34297780,The relationship between common mental disorders and incident diabetes among participants in the Kerala Diabetes Prevention Program (K-DPP).,"This study aims to describe the prevalence of depression and anxiety among a population sample of people at high risk for type 2 diabetes in Kerala, India, and examine the relationship between depressive symptoms, anxiety, and incident Type 2 Diabetes Mellitus (T2DM) over a two-year period. We used data from the Kerala Diabetes Prevention Program, a cluster-randomized controlled trial for diabetes prevention among 1007 high-risk individuals. The prevalence of depression and anxiety were estimated using the 9-item Patient Health Questionnaire and the Generalized Anxiety Disorder 7-item scale, respectively. We calculated proportions for depression and anxiety and performed generalized estimating equations (GEE) to examine the relationship between baseline mental health status and incident T2DM. The prevalence of depression and anxiety at baseline were 7.5% and 5.5%, respectively. Compared with those reporting none/low symptoms, the odds ratio for incident diabetes was 1.07 (95% CI 0.54-2.12) for participants with moderate to severe depression and 0.73 (95% CI 0.23-2.28) for participants with moderate to severe anxiety, after adjusting for potential confounders. Our findings suggest that the prevalence of depression and anxiety were higher than those previously reported in the general population in India. However, among this sample of community-based adults at high risk of developing T2DM, the presence of moderate to severe depression and/or anxiety symptoms was not significantly associated with the risk of developing T2DM. Trial registration: Australia and New Zealand Clinical Trials Registry ACTRN12611000262909. Registered 10 March 2011.",2021,"Compared with those reporting none/low symptoms, the odds ratio for incident diabetes was 1.07 (95% CI 0.54-2.12) for participants with moderate to severe depression and 0.73 (95% CI 0.23-2.28) for participants with moderate to severe anxiety, after adjusting for potential confounders.","['population sample of people at high risk for type 2 diabetes in Kerala, India', 'participants in the Kerala Diabetes Prevention Program (K-DPP', '1007 high-risk individuals']",[],"['depression and anxiety', 'odds ratio for incident diabetes', 'severe depression and/or anxiety symptoms', 'prevalence of depression and anxiety', '9-item Patient Health Questionnaire and the Generalized Anxiety Disorder 7-item scale']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0443018', 'cui_str': 'Kerala'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.189872,"Compared with those reporting none/low symptoms, the odds ratio for incident diabetes was 1.07 (95% CI 0.54-2.12) for participants with moderate to severe depression and 0.73 (95% CI 0.23-2.28) for participants with moderate to severe anxiety, after adjusting for potential confounders.","[{'ForeName': 'Leslie C M', 'Initials': 'LCM', 'LastName': 'Johnson', 'Affiliation': 'Department of Family and Preventive Medicine, School of Medicine, Emory University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Allissa', 'Initials': 'A', 'LastName': 'Desloge', 'Affiliation': 'School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Thirunavukkarasu', 'Initials': 'T', 'LastName': 'Sathish', 'Affiliation': 'School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Emily D', 'Initials': 'ED', 'LastName': 'Williams', 'Affiliation': 'School of Health Sciences, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Pilvikki', 'Initials': 'P', 'LastName': 'Absetz', 'Affiliation': 'Collaborative Care Systems Finland, Tampere University, Tampere, Finland.'}, {'ForeName': 'Tilahun', 'Initials': 'T', 'LastName': 'Haregu', 'Affiliation': 'School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'De Man', 'Affiliation': 'Centre for General Practice, Department of Primary and Interdisciplinary Care, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Kavumpurathu Raman', 'Initials': 'KR', 'LastName': 'Thankappan', 'Affiliation': 'Department of Public Health and Community Medicine, Central University of Kerala, Kasaragod, India.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}]",PloS one,['10.1371/journal.pone.0255217']
966,34302893,Assessment of Prognostic Value of High-Sensitivity Cardiac Troponin T for Early Prediction of Chemoradiation Therapy-Induced Cardiotoxicity in Patients with Non-Small Cell Lung Cancer: A Secondary Analysis of a Prospective Randomized Trial.,"PURPOSE


Cardiotoxicities induced by cancer therapy can negatively affect quality of life and survival. We investigated whether high-sensitivity cardiac troponin T (hs-cTnT) levels could serve as biomarker for early detection of cardiac adverse events (CAEs) after chemoradiation therapy (CRT) for non-small cell lung cancer (NSCLC).
METHODS AND MATERIALS


This study included 225 patients who received concurrent platinum and taxane-doublet chemotherapy with thoracic radiation therapy to a total dose of 60 to 74 Gy for NSCLC. All patients were evaluated for CAEs; 190 patients also had serial hs-cTnT measurements.
RESULTS


Grade ≥3 CAEs occurred in 24 patients (11%) at a median interval of 9 months after CRT. Pretreatment hs-cTnT levels were higher in men, in patients aged ≥64 years, and in patients with pre-existing heart disease or poor performance status (P < .05). hs-cTnT levels increased at 4 weeks during CRT (P < .05) and decreased after completion of CRT but did not return to pretreatment levels (P = .002). The change (Δ) in hs-cTnT levels during CRT correlated with mean heart dose (P = .0004), the heart volumes receiving 5 to 55 Gy (P < .05), and tumor location (P = .006). Risks of severe CAEs and mortality were significantly increased if the pretreatment hs-cTnT was >10 ng/L or the Δ during CRT was ≥5 ng/L.
CONCLUSIONS


Elevation of hs-cTnT during CRT was radiation heart dose-dependent, and high hs-cTnT levels during the course of CRT were associated with CAEs and mortality. Routine monitoring of hs-cTnT could identify patients who are at high risk of CRT-induced CAEs early to guide modifications of cancer therapy and possible interventions to mitigate cardiotoxicity.",2021,levels increased at 4 weeks during CRT (P<0.05) and decreased after completion of CRT but did not return to pretreatment levels (P=0.002).,"['Non-Small Cell Lung Cancer Patients', 'All patients were evaluated for CAEs; 190 patients also had serial hs-cTnT measurements', '225 patients who received']","['hs-cTnT', 'high-sensitivity cardiac troponin T (hs-cTnT', 'Chemoradiotherapy-Induced Cardiotoxicity', 'chemoradiation therapy (CRT', 'High-Sensitivity Cardiac Troponin T', 'concurrent platinum and taxane-doublet chemotherapy with thoracic radiotherapy to a total dose of 60-74 Gy for NSCLC']","['Risks of severe CAEs and mortality', 'quality of life and survival', 'levels']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C4517652', 'cui_str': '225'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",225.0,0.0904947,levels increased at 4 weeks during CRT (P<0.05) and decreased after completion of CRT but did not return to pretreatment levels (P=0.002).,"[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Departments of Radiation Oncology.'}, {'ForeName': 'Qing H', 'Initials': 'QH', 'LastName': 'Meng', 'Affiliation': 'Laboratory Medicine.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Gilchrist', 'Affiliation': 'Clinical Cancer Prevention and Cardiology.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Departments of Radiation Oncology.'}, {'ForeName': 'Ruitao', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Tianlin', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Biostatistics and Data Science, School of Public Health, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Milgrom', 'Affiliation': 'Department of Radiation Oncology, University of Colorado-Denver, Denver, Colorado.'}, {'ForeName': 'Saumil J', 'Initials': 'SJ', 'LastName': 'Gandhi', 'Affiliation': 'Departments of Radiation Oncology.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, Xiangya Hospital, Xiangya Medical School of Central South University, Hunan, P. R. of China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Medicine, University Hospital, Rochester, New York.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Lopez-Mattei', 'Affiliation': 'Departments of Cardiology.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Departments of Radiation Oncology. Electronic address: zliao@mdanderson.org.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.07.035']
967,34302758,"Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial.","BACKGROUND


Genetic data implicate IL-33 in asthma susceptibility. Itepekimab, a monoclonal antibody targeting IL-33, demonstrated clinical activity in asthma, with potential in chronic obstructive pulmonary disease (COPD). In this study we first aimed to test the hypothesis that genetic variants in the IL-33 pathway were also associated with COPD. On the basis of the strong association of IL-33 pathway genes with pulmonary diseases like asthma and COPD, we conducted this phase 2a trial to assess the safety and efficacy of itepekimab in patients with moderate-to-severe COPD on a stable regimen of triple-inhaled or double-inhaled background maintenance therapy.
METHODS


In this two-part study, genetic analyses of loss-of-function and gain-of-function variants in the IL-33 pathway, previously associated with asthma risk, were initially characterised for COPD. We then did a double-blind, phase 2a trial comparing itepekimab with placebo in patients with moderate-to-severe COPD despite standard therapy, at 83 study sites in ten countries. Patients aged 40-75 years who were current or former smokers, had been diagnosed with COPD for at least 1 year, and were on a stable regimen of triple-inhaled or double-inhaled background maintenance therapy, were randomly assigned (1:1) to receive itepekimab 300 mg or placebo, administered as two subcutaneous injections every 2 weeks for 24-52 weeks. The primary endpoint of the phase 2a trial was annualised rate of moderate-to-severe acute exacerbations of COPD during the treatment period. The key secondary outcome was change in prebronchodilator FEV 1  from baseline to weeks 16-24. Prespecified subgroup analyses were done for each of the endpoints, including by smoking status. Efficacy and safety analyses were done in all participants who received at least one dose of assigned treatment (modified intention-to-treat population). This trial is registered at ClinicalTrials.gov (NCT03546907).
FINDINGS


Genetic analyses demonstrated association of loss of function in IL33 with reduced COPD risk, and gain of function in IL33 and IL1RL1 variants with increased risk. Subsequent to this, in the phase 2 trial, 343 patients were randomly assigned to placebo (n=171) or itepekimab (n=172) from July 16, 2018, to Feb 19, 2020. Annualised rates of acute exacerbations of COPD were 1·61 (95% CI 1·32-1·97) in the placebo group and 1·30 (1·05-1·61) in the itepekimab group (relative risk [RR] 0·81 [95% CI 0·61-1·07], p=0·13), and least squares mean prebronchodilator FEV 1  change from baseline to weeks 16-24 was 0·0 L (SD 0·02) and 0·06 L (0·02; difference 0·06 L [95% CI 0·01-0·10], p=0·024). When analysis was restricted to former smokers, treatment with itepekimab was associated with nominally significant reductions in acute exacerbations of COPD (RR 0·58 [95% CI 0·39-0·85], p=0·0061) and FEV 1  improvement (least squares mean difference 0·09 L [0·02-0·15], p=0·0076) compared with placebo. Current smokers treated with itepekimab showed no treatment benefit versus placebo for exacerbations (RR 1·09 [0·74-1·61], p=0·65) or FEV 1  (least squares mean difference 0·02 [-0·05 to 0·09], p=0·54). Treatment-emergent adverse events (TEAEs) occurred in 135 (78%) patients in the itepekimab group and 136 (80%) in the placebo group. The most common TEAEs were nasopharyngitis (28 [16%] in the itepekimab group vs 29 [17%] in the placebo group), bronchitis (18 [10%] vs 14 [8%]), headache (14 [8%] vs 23 [13%]), and upper respiratory tract infection (13 [8%] vs 15 [9%]).
INTERPRETATION


The primary endpoint in the overall population was not met, subgroup analysis showed that itepekimab reduced exacerbation rate and improved lung function in former smokers with COPD. Two phase 3 clinical studies are ongoing to confirm the efficacy and safety profile of itepekimab in former smokers with COPD.
FUNDING


Sanofi and Regeneron Pharmaceuticals.",2021,Annualised rates of acute exacerbations of COPD were 1·61 (95% CI 1·32-1·97) in the placebo group and 1·30,"['participants who received at least one dose of assigned treatment (modified intention-to-treat population', 'patients with moderate-to-severe COPD on a stable regimen of triple-inhaled or double-inhaled background maintenance therapy', 'patients with moderate-to-severe COPD despite standard therapy, at 83 study sites in ten countries', 'chronic obstructive pulmonary disease (COPD', 'patients with moderate-to-severe COPD', '343 patients', 'Patients aged 40-75 years who were current or former smokers, had been diagnosed with COPD for at least 1 year, and were on a stable regimen of triple-inhaled or double-inhaled background maintenance therapy']","['placebo', 'itepekimab with placebo', 'itepekimab', 'itepekimab 300 mg or placebo']","['mean prebronchodilator FEV', 'acute exacerbations of COPD (RR 0·58', 'Efficacy and safety analyses', 'bronchitis', 'exacerbation rate and improved lung function', 'Safety and efficacy', 'annualised rate of moderate-to-severe acute exacerbations of COPD', 'nasopharyngitis', 'headache', 'upper respiratory tract infection', 'Annualised rates of acute exacerbations of COPD', 'prebronchodilator FEV']","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}]",343.0,0.930957,Annualised rates of acute exacerbations of COPD were 1·61 (95% CI 1·32-1·97) in the placebo group and 1·30,"[{'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'LungenClinic Grosshansdorf, Grosshansdorf, Germany; Christian Albrechts University of Kiel, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany. Electronic address: k.f.rabe@lungenclinic.de.'}, {'ForeName': 'Bartolome R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': ""Pulmonary and Critical Care Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Raolat M', 'Initials': 'RM', 'LastName': 'Abdulai', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Maarten M', 'Initials': 'MM', 'LastName': 'Boomsma', 'Affiliation': 'Sanofi, Amsterdam, Netherlands.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Staudinger', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Horowitz', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Baras', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Ferreira', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Marcella K', 'Initials': 'MK', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Nivens', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Goulaouic', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00167-3']
968,34304268,"An intervention to increase physical activity in care home residents: results of a cluster-randomised, controlled feasibility trial (the REACH trial).","BACKGROUND


Care home (CH) residents are mainly inactive, leading to increased dependency and low mood. Strategies to improve activity are required.
DESIGN AND SETTING


Cluster randomised controlled feasibility trial with embedded process and health economic evaluations. Twelve residential CHs in Yorkshire, United Kingdom, were randomised to the MoveMore intervention plus usual care (UC) (n = 5) or UC only (n = 7).
PARTICIPANTS


Permanent residents aged ≥65 years.
INTERVENTION


MoveMore: a whole home intervention involving all CH staff designed to encourage and support increase in movement of residents.
OBJECTIVES AND MEASUREMENTS


Feasibility objectives relating to recruitment, intervention delivery, data collection and follow-up and safety concerns informed the feasibility of progression to a definitive trial. Data collection at baseline, 3, 6 and 9 months included: participants' physical function and mobility, perceived health, mood, quality of life, cognitive impairment questionnaires; accelerometry; safety data; intervention implementation.
RESULTS


300 residents were screened; 153 were registered (62 MoveMore; 91 UC). Average cluster size: MoveMore: 12.4 CHs; UC: 13.0 CHs. There were no CH/resident withdrawals. Forty (26.1%) participants were unavailable for follow-up: 28 died (12 MoveMore; 16 UC); 12 moved from the CH. Staff informant/proxy data collection for participants was >80%; data collection from participants was <75%; at 9 months, 65.6% of residents provided valid accelerometer data; two CHs fully, two partially and one failed to implement the intervention. There were no safety concerns.
CONCLUSIONS


Recruiting CHs and residents was feasible. Intervention implementation and data collection methods need refinement before a definitive trial. There were no safety concerns.",2021,There were no safety concerns.,"['care home residents', '300 residents were screened; 153 were registered (62 MoveMore; 91 UC', 'Permanent residents aged ≥65\xa0years', 'Twelve residential CHs in Yorkshire, United Kingdom']","['MoveMore: a whole home intervention involving all CH staff designed to encourage and support increase in movement of residents', 'MoveMore intervention plus usual care (UC) (n\u2009=\u20095) or UC']","['physical function and mobility, perceived health, mood, quality of life, cognitive impairment questionnaires; accelerometry; safety data; intervention implementation', 'physical activity']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",300.0,0.197996,There were no safety concerns.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Airlie', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Ellwood', 'Affiliation': 'Centre for Dementia Studies, University of Bradford, Bradford, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Godfrey', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Cundill', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Dawkins', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McMaster', 'Affiliation': 'NHS England and NHS Improvement, Leeds, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Institute of Health Research, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Cicero', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds UK.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'McLellan', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Graham', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Bev', 'Initials': 'B', 'LastName': 'Gallagher', 'Affiliation': 'NHS Bradford District and Craven Clinical Commissioning Group, Bradford, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Ellard', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Firth', 'Affiliation': 'Patient and Public Involvement Contributor, Ilkley, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Age and ageing,['10.1093/ageing/afab130']
969,34309839,High-flow nasal cannula versus face mask for preoxygenation in obese patients: A randomised controlled trial.,"BACKGROUND


Preoxygenation efficacy with high-flow nasal cannula (HFNC) in obese patients is not clearly established. The primary aim of this study was to compare heated, humidified, high-flow nasal cannula with face mask for preoxygenation in this population.
METHODS


We conducted a single-centre, randomised, controlled trial. Forty subjects with BMI ≥ 35 kg m -2  were randomly assigned to receive 5.0 min of preoxygenation with face mask and 7 cm H 2  O of PEEP (PEEP group) or HFNC at 70 L min -1  (HF group). Following induction, bag-mask ventilation continued until laryngoscopy, whereas HFNC was maintained before and during intubation. The primary outcomes were end-tidal fraction of oxygen (EtO 2  ) at 2.5 and 5.0 min duration of preoxygenation. Secondary outcomes included PaO 2  and PaCO 2  at 2.5 and 5.0 min of preoxygenation and at intubation.
RESULTS


Mean (±SD) EtO 2  was 0.89 (±0.04) versus 0.90 (±0.05) after 2.5 min (95% CI for mean difference -0.02, 0.04) and 0.93 (±0.02) versus 0.91 (±0.02) after 5.0 min of preoxygenation (95% CI for mean difference -0.03, -0.002) in the PEEP (n = 18) and HF group (n = 20), respectively. All subjects reached an EtO 2   ≥ 0.85 at 5.0 min. There were no differences in mean PaO 2  or PaCO 2  during preoxygenation. Subjects in the HF group had a mean (±SD) apnoea time of 199 (±38) s, but no desaturation (SpO 2   < 100%) occurred.
CONCLUSIONS


Face mask with PEEP was superior to HFNC for preoxygenation in obese subjects. HFNC provided adequate preoxygenation quality in all subjects and may be considered as an alternative to face mask in selected patients.
TRIAL REGISTRATION


#ISRCTN37375068 (www.isrctn.com).",2021,"EtO 2  was 0.89 (±0.04) vs. 0.90 (±0.05) after 2.5 min (95% CI for mean difference -0.02, 0.04) and 0.93 (±0.02) vs 0.91 (±0.02) after 5.0 min of preoxygenation (95% CI for mean difference -0.03, -0.002) in the PEEP (n=18) and HF group (n=20) respectively.","['obese subjects', 'Forty subjects with BMI≥35 kg m -2', 'obese patients']","['PEEP', 'preoxygenation with face-mask and 7 cmH 2  O of PEEP (PEEP group) or HFNC', 'High flow nasal cannula versus face-mask', 'high flow nasal cannula (HFNC', 'HFNC', 'heated, humidified, high flow nasal cannula with face-mask']","['PaO 2  and PaCO 2  at 2.5 and 5.0 min of preoxygenation and at intubation', 'mean (±SD) apnoea time of 199 (±38) seconds but no desaturation', 'Mean (±SD', 'adequate preoxygenation quality', 'tidal fraction of oxygen (EtO 2  ']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0412792', 'cui_str': 'Preoxygenation'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0412792', 'cui_str': 'Preoxygenation'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0218234', 'cui_str': 'CBFA2T1 protein, human'}]",40.0,0.299943,"EtO 2  was 0.89 (±0.04) vs. 0.90 (±0.05) after 2.5 min (95% CI for mean difference -0.02, 0.04) and 0.93 (±0.02) vs 0.91 (±0.02) after 5.0 min of preoxygenation (95% CI for mean difference -0.03, -0.002) in the PEEP (n=18) and HF group (n=20) respectively.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Rosén', 'Affiliation': 'Department of Surgical Sciences, Section of Anaesthesiology and Intensive Care Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Frykholm', 'Affiliation': 'Department of Surgical Sciences, Section of Anaesthesiology and Intensive Care Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Diddi', 'Initials': 'D', 'LastName': 'Fors', 'Affiliation': 'Department of Surgical Sciences, Section of Anaesthesiology and Intensive Care Medicine, Uppsala University, Uppsala, Sweden.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13960']
970,34309813,Efficacy of Peginterferon alfa-2b in Nucleoside Analogue Experienced Patients with Negative HBeAg and Low HBsAg: A Non-Randomized Clinical Trial.,"INTRODUCTION


Hepatitis B surface antigen (HBsAg) clearance is the treatment goal for hepatitis B e antigen (HBeAg)-negative patients with chronic hepatitis B (CHB). However, its rate is extremely low with nucleoside (acid) analogues (NAs) monotherapy. Peginterferon could enhance HBsAg clearance. This study aimed to evaluate the efficacy of peginterferon alfa-2b (PegIFNα-2b) in NAs-experienced patients with CHB with negative HBeAg and low HBsAg level.
METHODS


HBeAg-negative patients with CHB who had received NAs therapy over 24 weeks with HBsAg < 1500 IU/mL and HBV DNA < 100 IU/mL were enrolled. Patients received either PegIFNα-2b add-on therapy (n = 108) or continuous NAs monotherapy (n = 75). The primary endpoint was HBsAg clearance rate at week 48.
RESULTS


At week 48, serum HBV DNA was undetectable among all PegIFNα-2b add-on therapy patients. Almost all patients maintained HBV DNA suppression in the PegIFNα-2b add-on group (100%, 108/108) and NAs monotherapy group (97.33%, 73/75). Only patients with PegIFNα-2b add-on therapy achieved HBsAg clearance (50.93%, 55/108) and HBsAg seroconversion (48.15%, 52/108) at week 48. Patients with baseline HBsAg < 100 IU/mL achieved the highest HBsAg clearance rate and HBsAg seroconversion rate at week 48 (60.87%, 28/46 and 58.70%, 27/46 respectively). HBsAg clearance and HBsAg seroconversion at week 72 had no significant difference with continuing or discontinuing PegIFNα-2b therapy after 48 weeks of treatment. PegIFNα-2b add-on therapy was well tolerated.
CONCLUSIONS


PegIFNα-2b add-on therapy increases HBsAg clearance rate and seroconversion rate for HBeAg-negative patients with CHB, particularly for those with lower HBsAg level. It would be unnecessary to prolong PegIFNα-2b duration after 48 weeks of PegIFNα-2b treatment.",2021,HBsAg clearance and HBsAg seroconversion at week 72 had no significant difference with continuing or discontinuing PegIFNα-2b therapy after 48 weeks of treatment.,"['hepatitis\xa0B e antigen (HBeAg)-negative patients with chronic hepatitis\xa0B (CHB', 'NAs-experienced patients with CHB with negative HBeAg and low HBsAg level', 'Patients with baseline HBsAg', 'HBeAg-negative patients with CHB who had received NAs therapy over 24\xa0weeks with HBsAg', 'Nucleoside Analogue Experienced Patients with Negative HBeAg and Low HBsAg']","['Peginterferon alfa-2b', 'peginterferon alfa-2b (PegIFNα-2b', 'PegIFNα-2b add-on therapy (n\u2009=\u2009108) or continuous NAs monotherapy', 'nucleoside (acid) analogues (NAs) monotherapy', 'Peginterferon']","['highest HBsAg clearance rate and HBsAg seroconversion rate', 'enhance HBsAg clearance', 'HBsAg clearance', 'HBsAg clearance rate and seroconversion rate', 'tolerated', 'serum HBV DNA', 'HBV DNA suppression', 'HBsAg clearance and HBsAg seroconversion', 'HBsAg clearance rate', 'HBsAg seroconversion']","[{'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0948827', 'cui_str': 'Hepatitis B e antigen negative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0796545', 'cui_str': 'peginterferon alfa-2b'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.0892216,HBsAg clearance and HBsAg seroconversion at week 72 had no significant difference with continuing or discontinuing PegIFNα-2b therapy after 48 weeks of treatment.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China.'}, {'ForeName': 'Xue-Gong', 'Initials': 'XG', 'LastName': 'Fan', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China.'}, {'ForeName': 'Xing-Wang', 'Initials': 'XW', 'LastName': 'Hu', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China.'}, {'ForeName': 'Cheng-Jin', 'Initials': 'CJ', 'LastName': 'Liao', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China.'}, {'ForeName': 'Li-Yuan', 'Initials': 'LY', 'LastName': 'Long', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China.'}, {'ForeName': 'Xiao-Ting', 'Initials': 'XT', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China.'}, {'ForeName': 'Hai-Fu', 'Initials': 'HF', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China.'}, {'ForeName': 'Ruo-Chan', 'Initials': 'RC', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China.'}, {'ForeName': 'Ze-Bing', 'Initials': 'ZB', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China. 36165934@qq.com.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Xiangya Road 87, Kaifu District, Changsha, 410008, China. drhyan@126.com.'}]",Infectious diseases and therapy,['10.1007/s40121-021-00497-5']
971,34305665,The Effects of Cannabis Use Frequency and Episodic Specificity Training on the Recall of Specific and Rewarding Events.,"Background:  Growing evidence implicates subjective episodic memory, the retrieval of detailed, integrated, and personally relevant past events, as a marker of cognitive vulnerability in mental disorders. Frequent and problematic cannabis use is associated with deficits in objective episodic memory (verbal memory), but the relationship between subjective episodic memory deficits and frequency of cannabis use is unknown. Further, whether a brief intervention designed to enhance the specificity of event retrieval, such as the Episodic Specificity Induction (ESI), might effectively target such deficits among regular cannabis users is unexamined. This study was designed to examine subjective episodic memory as a potential marker of cognitive vulnerability among frequent cannabis users.  Methods:  Active cannabis users ( n  = 133) recruited from Amazon Mechanical Turk or Qualtrics Panels were randomized to receive an ESI-control or ESI session and were separated into those who used cannabis 1-25 days in the past month (low to moderate frequency group) and those who used 26-30 days (high frequency group), which facilitated a low to moderate use/ESI-control group ( n  = 78), low to moderate use/ESI group ( n  =15), high-use/ESI-control group ( n  = 20), and high-use/ESI group ( n  = 20). Following the ESI or ESI-control intervention, participants selected four, positive events from the prior day, described the who, what, and where of the events, and rated how specific (vividness) and rewarding (enjoyable, importance, and exciting) each event was on a 0-100 scale. Four two-way ANCOVAs (demographics and problematic cannabis use covariates) were performed to examine the effects of frequency of cannabis use group and ESI group on the specificity and reward ratings.  Results:  Lower vividness and excitement ratings were reported for those with high relative to low to moderate cannabis use frequency patterns ( p  < 0.05). Those who received ESI reported greater vividness, excitement, and importance ratings than the ESI-control group ( p  < 0.01). No significant interactions between frequency and ESI were found.  Conclusion:  Findings from the current exploratory study provide initial evidence suggesting that more frequent cannabis use may be associated with the retrieval of less specific and rewarding events relative to less frequent users. Further, ESI may improve such deficits. Future studies that recruit larger and more clinically serious samples of cannabis users appear warranted.",2021,Results:  Lower vividness and excitement ratings were reported for those with high relative to low to moderate cannabis use frequency patterns ( p  < 0.05).,"['frequent cannabis users', 'Active cannabis users ( n  = 133) recruited from Amazon Mechanical Turk or Qualtrics Panels']","['ESI-control or ESI session and were separated into those who used cannabis 1-25 days in the past month (low to moderate frequency group) and those who used 26-30 days (high frequency group), which facilitated a low to moderate use/ESI-control group ( n  = 78), low to moderate use/ESI group ( n  =15), high-use/ESI-control group ( n  = 20), and high-use/ESI', 'Cannabis Use Frequency and Episodic Specificity Training']","['objective episodic memory (verbal memory', 'subjective episodic memory', 'greater vividness, excitement, and importance ratings', 'Recall of Specific and Rewarding Events']","[{'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0233571', 'cui_str': 'Excitement'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",133.0,0.00897459,Results:  Lower vividness and excitement ratings were reported for those with high relative to low to moderate cannabis use frequency patterns ( p  < 0.05).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sofis', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, United States.'}, {'ForeName': 'Shea M', 'Initials': 'SM', 'LastName': 'Lemley', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, United States.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Budney', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2021.643819']
972,34310498,"Four-Second Power Cycling Training Increases Maximal Anaerobic Power, Peak Oxygen Consumption, and Total Blood Volume.","INTRODUCTION


High-intensity interval training is an effective tool to improve cardiovascular fitness and maximal anaerobic power. Different methods of high-intensity interval training have been studied but the effects of repeated maximal effort cycling with very short exercise time (i.e., 4 s) and short recovery time (15-30 s) might suit individuals with limited time to exercise.
PURPOSE


We examined the effects of training at near maximal anaerobic power during cycling (PC) on maximal anaerobic power, peak oxygen consumption (V˙O2peak), and total blood volume in 11 young healthy individuals (age: 21.3 ± 0.5 yr) (six men, five women).
METHODS


Participants trained three times a week for 8 wk performing a PC program consisting of 30 bouts of 4 s at an all-out intensity (i.e., 2 min of exercise per session). The cardiovascular stress progressively increased over the weeks by decreasing the recovery time between sprints (30-24 s to 15 s), and thus, total session time decreased from 17 to <10 min.
RESULTS


Power cycling elicited a 13.2% increase in V˙O2peak (Pre: 2.86 ± 0.18 L·min-1, Post: 3.24 ± 0.21 L·min-1; P = 0.003) and a 7.6% increase in total blood volume (Pre: 5139 ± 199 mL, Post: 5529 ± 342 mL; P < 0.05). Concurrently, maximal anaerobic power increased by 17.2% (Pre: 860 ± 53 W, Post: 1,009 ± 71 W; P < 0.001).
CONCLUSIONS


A PC training program employing 30 bouts of 4 s duration for a total of 2 min of exercise, resulting in a total session time of less than 10 min in the last weeks, is effective for improving total blood volume, V˙O2peak and maximal anaerobic power in young healthy individuals over 8 wk. These observations require reconsideration of the minimal amount of exercise needed to significantly increase both maximal aerobic and anaerobic power.",2021,"RESULTS


PC elicited a 13.2% increase in VO2peak (Pre: 2.86 ± 0.18 L/min, Post: 3.24 ± 0.21 L/min, (p = 0.003) and a 7.6% increase in total blood volume (Pre: 5,139 ± 199 ml, Post: 5,529 ± 342 ml, p < 0.05).","['young healthy individuals', '11 young healthy individuals (age: 21.3 ± 0.5 y) (6 men, 5 women']","['High-intensity interval training (HIIT', 'training at near maximal anaerobic power during cycling (PC']","['maximal aerobic and anaerobic power', 'cardiovascular stress', 'total blood volume, VO2peak and maximal anaerobic power', 'cardiovascular fitness and maximal anaerobic power', 'recovery time', 'maximal anaerobic power, peak oxygen consumption (VO2peak), and total blood volume', 'VO2peak', 'Maximal Anaerobic Power, Peak Oxygen Consumption, and Total Blood Volume', 'total blood volume', 'total session time', 'maximal anaerobic power']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0429890', 'cui_str': 'Total blood volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",11.0,0.0109491,"RESULTS


PC elicited a 13.2% increase in VO2peak (Pre: 2.86 ± 0.18 L/min, Post: 3.24 ± 0.21 L/min, (p = 0.003) and a 7.6% increase in total blood volume (Pre: 5,139 ± 199 ml, Post: 5,529 ± 342 ml, p < 0.05).","[{'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Satiroglu', 'Affiliation': 'Human Performance Laboratory, University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Lalande', 'Affiliation': 'Clinical Exercise Physiology Laboratory, Department of Kinesiology and Health Education, University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Sungmo', 'Initials': 'S', 'LastName': 'Hong', 'Affiliation': 'Human Performance Laboratory, University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Mercedes J', 'Initials': 'MJ', 'LastName': 'Nagel', 'Affiliation': 'Clinical Exercise Physiology Laboratory, Department of Kinesiology and Health Education, University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Coyle', 'Affiliation': 'Human Performance Laboratory, University of Texas at Austin, Austin, TX.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002748']
973,34314816,Greater efficacy of a combination of conservative therapies for thumb base OA in individuals with lower radial subluxation - a pre-planned subgroup analysis of the COMBO trial.,"OBJECTIVE


To investigate heterogeneous effects of a combination of conservative therapies compared with an education comparator for thumb base (TB) osteoarthritis (OA) according to clinically relevant characteristics.
METHODS


Pre-planned subgroup analysis of the COMBO trial (n = 204) which compared a combination of education on self-management and ergonomic principles, a prefabricated neoprene splint, hand exercises, and diclofenac sodium gel, with education alone for radiographic and symptomatic TB OA. Primary outcomes were change in pain (visual analogue scale [VAS], 0-100 mm) and hand function (Functional Index for Hand Osteoarthritis questionnaire, 0-30) from baseline to week-6. Other outcomes were grip and tip-pinch strength and patient's global assessment (PGA) (VAS, 0-100 mm). Possible treatment effect modifiers were the presence of interphalangeal joint pain, erosive hand OA, radiographic thumb carpometacarpal joint subluxation (higher vs equal or lower than the sample mean), and baseline radiographic OA severity (Kellgren Lawrence grade). Linear regression models were fitted, adding interaction terms for each subgroup of interest.
RESULTS


The treatment effects of the combined intervention at 6 weeks were greater in participants with lower joint subluxation compared with those with greater subluxation (pain -11.6 [95%CI -22.2, -9.9] and 2.6 [-5.5, 10.7], respectively, difference between the subluxation groups 14.2 units (95% CI 2.3, 26.1), p-value 0.02; and PGA -14.0 [-22.4, -5.5] and 1.5 [-6.2, 9.3), respectively, difference between the subluxation groups 15.5 units (95% CI 4.2, 26.8), p-value 0.03). There was no statistically significant heterogeneity for the other subgroups.
CONCLUSION


A combination of conservative therapies may provide greater benefits over 6 weeks in individuals with lower joint subluxation, although the clinical relevance is uncertain given the wide confidence intervals. Treatment strategies may need to be customized for those with greater joint subluxation.
TRIAL REGISTRATION NUMBER


ACTRN 12616000353493.",2021,"The treatment effects of the combined intervention at 6 weeks were greater in participants with lower joint subluxation compared with those with greater subluxation (pain -11.6 [95%CI -22.2, -9.9] and 2.6 [-5.5, 10.7], respectively, difference between the subluxation groups 14.2 units (95% CI 2.3, 26.1), p-value 0.02; and PGA -14.0 [-22.4, -5.5] and 1.5 [-6.2, 9.3), respectively, difference between the subluxation groups 15.5 units (95% CI 4.2, 26.8), p-value 0.03).","['individuals with lower radial subluxation - a pre-planned subgroup analysis of the COMBO trial', 'individuals with lower joint subluxation']","['prefabricated neoprene splint, hand exercises, and diclofenac sodium gel, with education alone', 'conservative therapies']","['baseline radiographic OA severity (Kellgren Lawrence grade', ""grip and tip-pinch strength and patient's global assessment (PGA) (VAS, 0-100mm"", 'change in pain (visual analogue scale [VAS], 0-100 mm) and hand function (Functional Index for Hand Osteoarthritis questionnaire, 0-30', 'interphalangeal joint pain, erosive hand OA, radiographic thumb carpometacarpal joint subluxation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0149977', 'cui_str': 'Pulled elbow'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332768', 'cui_str': 'Subluxation of joint'}]","[{'cui': 'C0027673', 'cui_str': 'Neoprene'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0454330', 'cui_str': 'Hand exercises'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0429273', 'cui_str': 'Tip pinch'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1563055', 'cui_str': 'Interphalangeal joint structure'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0224620', 'cui_str': 'Carpometacarpal joint structure'}, {'cui': 'C0332768', 'cui_str': 'Subluxation of joint'}]",204.0,0.150883,"The treatment effects of the combined intervention at 6 weeks were greater in participants with lower joint subluxation compared with those with greater subluxation (pain -11.6 [95%CI -22.2, -9.9] and 2.6 [-5.5, 10.7], respectively, difference between the subluxation groups 14.2 units (95% CI 2.3, 26.1), p-value 0.02; and PGA -14.0 [-22.4, -5.5] and 1.5 [-6.2, 9.3), respectively, difference between the subluxation groups 15.5 units (95% CI 4.2, 26.8), p-value 0.03).","[{'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Deveza', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia. Electronic address: leticia.alle@sydney.edu.au.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Robbins', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Duong', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fu', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wajon', 'Affiliation': 'Macquarie University Clinic, Macquarie Hand Therapy, Macquarie University, New South Wales, Australia.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Eyles', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jongs', 'Affiliation': 'Physiotherapy Department, Royal North Shore Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Riordan', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Oo', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2021.07.010']
974,34351478,[Update on intravenous lysis treatment : The REVISION trial].,"BACKGROUND


To date, no evidence-based treatment for acute non-arteritic central retinal artery occlusion (CRAO) exists. Considering the limited ischemia tolerance of the retina and the results of multiple case series, increasing expectations are directed towards an early intravenous thrombolysis within 4.5 h after CRAO onset.
OBJECTIVE


The current literature regards timely retinal reperfusion as the only potentially beneficial therapeutic option to treat non-arteritic CRAO. Available data on the efficacy and safety of thrombolysis in CRAO are presented and discussed. On the basis of these data, the prospective, randomized, double-blind, placebo-controlled REVISION trial (early REperfusion therapy with intravenous alteplase for recovery of VISION in acute central retinal artery occlusion) will shortly be initiated in 25 centers across Germany in order to investigate early intravenous thrombolysis in acute CRAO. The main inclusion criteria of the REVISION trial are outlined, which may help ophthalmologists to identify study candidates and facilitate rapid referral to a study center.
CONCLUSION


The efficacy of intravenous thrombolysis in acute ischemic stroke is critically time dependent. This may also be assumed in acute CRAO; however, definite evidence still needs to be provided. Until then, the motto ""time is retina"" should be applied and intravenous thrombolysis should be offered to CRAO patients as part of randomized trials (such as REVISION). According to the current literature, other acute treatment approaches (such as paracentesis) are not indicated.",2021,The efficacy of intravenous thrombolysis in acute ischemic stroke is critically time dependent.,"['acute ischemic stroke', 'acute central retinal artery occlusion', '25\xa0centers across Germany in order to investigate early intravenous thrombolysis in acute CRAO']","['placebo', 'intravenous thrombolysis']",[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0007688', 'cui_str': 'Central retinal artery occlusion'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]",[],,0.170338,The efficacy of intravenous thrombolysis in acute ischemic stroke is critically time dependent.,"[{'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Schultheiss', 'Affiliation': 'Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf (UKE), Martinistr.\xa052, 20246, Hamburg, Deutschland. m.schultheiss@uke.de.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Spitzer', 'Affiliation': 'Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf (UKE), Martinistr.\xa052, 20246, Hamburg, Deutschland.'}, {'ForeName': 'Lars-Olof', 'Initials': 'LO', 'LastName': 'Hattenbach', 'Affiliation': 'Augenklinik, Klinikum Ludwigshafen, Ludwigshafen, Deutschland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Poli', 'Affiliation': 'Hertie-Institut für klinische Hirnforschung, Universitätsklinikum Tübingen, Tübingen, Deutschland.'}]",Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft,['10.1007/s00347-021-01467-5']
975,34351436,Telomerase-based GX301 cancer vaccine in patients with metastatic castration-resistant prostate cancer: a randomized phase II trial.,"Debate is around the optimal immunization regimen for cancer vaccines since too intense vaccination schedules may exhaust reactive lymphocytes. GX301 is a telomerase-based cancer vaccine whose safety and immunological effects were tested in a phase I trial applying an eight administrations schedule. Main objective of this study was to comparatively analyse safety and immunological response to three GX301 regimens in metastatic castration-resistant prostate cancer patients with response/disease stability after docetaxel chemotherapy. This was a multicentre, randomized, parallel-group, open-label trial registered with EudraCT (2014-000095-26) and ClinicalTrials.gov (NCT02293707, 2014). Ninety-eight patients were randomized to receive either eight (regimen 1), four (regimen 2) or two (regimen 3) vaccine administrations. Sixty-three patients were assessable for the primary immunological end-point. Vaccine-specific immune responses were evaluated by intracellular staining for IFN, elispot and cytotoxic assay at 90 and 180 days from baseline. No major side effects were recorded. A 54% overall immune responder rate was observed with 95% of patients showing at least one vaccine-specific immune response. Rate of immunological responders and number of immunizations were proportionally related, suggesting superiority of regimens 1 and 2 over regimen 3. Overall survival did not differ among regimens in both immunological responders and non-responders and was inversely associated (P = 0.002) with increase in the number of circulating CD8 + T regulatory cells at 180 days. These data indicate that GX301 cancer vaccine is safe and immunogenic in metastatic castration-resistant prostate cancer patients. Schedules with high number of administrations should be preferred in future studies due to their better immunological outcome.",2021,Overall survival did not differ among regimens in both immunological responders and non-responders and was inversely associated (P = 0.002) with increase in the number of circulating CD8 + T regulatory cells at 180 days.,"['patients with metastatic castration-resistant prostate cancer', 'Ninety-eight patients', 'metastatic castration-resistant prostate cancer patients', 'metastatic castration-resistant prostate cancer patients with response/disease stability after docetaxel chemotherapy']","['GX301 cancer vaccine', 'EudraCT', 'Telomerase-based GX301 cancer vaccine', 'GX301', 'GX301 regimens']","['Rate of immunological responders and number of immunizations', 'number of circulating CD8\u2009+\u2009T regulatory cells', 'safety and immunological response', 'Overall survival', 'immune responder rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0376659', 'cui_str': 'Vaccines, Cancer'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",98.0,0.25935,Overall survival did not differ among regimens in both immunological responders and non-responders and was inversely associated (P = 0.002) with increase in the number of circulating CD8 + T regulatory cells at 180 days.,"[{'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Filaci', 'Affiliation': 'Department of Internal Medicine, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fenoglio', 'Affiliation': 'Department of Internal Medicine, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Nolè', 'Affiliation': 'Medical Oncology Division of Urogenital and Head and Neck Tumours IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Zanardi', 'Affiliation': 'Academic Unit of Medical Oncology, IRCCS Ospedale Policlinico San Martino, Viale Benedetto XV, 16132, Genoa, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tomasello', 'Affiliation': 'Academic Unit of Medical Oncology, IRCCS Ospedale Policlinico San Martino, Viale Benedetto XV, 16132, Genoa, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Aglietta', 'Affiliation': 'Division of Medical Oncology, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Del Conte', 'Affiliation': 'Department of Oncology, IRCCS San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Carles', 'Affiliation': ""Vall d'Hebron Institut d'Oncologia, Barcelona, Spain.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Morales-Barrera', 'Affiliation': ""Vall d'Hebron Institut d'Oncologia, Barcelona, Spain.""}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Guglielmini', 'Affiliation': 'Oncology Unit, SS Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Scagliotti', 'Affiliation': 'Department of Oncology, San Luigi Gonzaga Hospital Orbassano and University of Turin, Turin, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Signori', 'Affiliation': 'Department of Health Science, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Parodi', 'Affiliation': 'Biotherapy Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Kalli', 'Affiliation': 'Department of Internal Medicine, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Astone', 'Affiliation': 'Department of Internal Medicine, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ferrera', 'Affiliation': 'Department of Internal Medicine, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Altosole', 'Affiliation': 'Department of Internal Medicine, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Lamperti', 'Affiliation': 'Mediolanum Farmaceutici Spa, Milan, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Criscuolo', 'Affiliation': 'Mediolanum Farmaceutici Spa, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Gianese', 'Affiliation': 'Mediolanum Farmaceutici Spa, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Department of Internal Medicine, University of Genoa, Genoa, Italy. fboccardo@unige.it.'}]","Cancer immunology, immunotherapy : CII",['10.1007/s00262-021-03024-0']
976,34353985,Incisional Surgical Site Infections After Mass and Layered Closure of Upper Abdominal Transverse Incisions: First Results of a Randomized Controlled Trial.,"OBJECTIVE


To compare the early results of mass and layered closure of upper abdominal transverse incisions.
SUMMARY OF BACKGROUND DATA


Contrary to midline incisions, data on closure of transverse abdominal incisions are lacking.
METHODS


This is the first analysis of a randomized controlled trial primarily designed to compare mass with layered closure of transverse incisions with respect to incisional hernias. Patients undergoing laparotomy through upper abdominal transverse incisions were randomized to either mass or layered closure with continuous sutures. Incisional surgical site infection (incisional-SSI) was the primary end-point. Secondary end-points comprised suture-to-wound length ratio (SWLR), closure duration, and fascial dehiscence (clinicatrials.gov NCT03561727).
RESULTS


A total of 268 patients were randomized to either mass (n=134) or layered (n=134) closure. Incisional-SSIs occurred in 24 (17.9%) and 8 (6.0%) patients after mass and layered closure, respectively (P =0.004), with crude odds ratio (OR) of 0.29 [95% confidence interval (95% CI) 0.13-0.67; P =0.004]. Layered technique was independently associated with fewer incisional-SSIs (OR: 0.29; 95% CI 0.12-0.69; P =0.005). The number needed to treat, absolute, and relative risk reduction for layered technique in reducing incisional-SSIs were 8.4 patients, 11.9%, and 66.5%, respectively. Dehiscence occurred in one (0.8%) patient after layered closure and in two (1.5%) patients after mass closure (P >0.999). Median SWLR were 8.1 and 5.6 (P <0.001) with median closure times of 27.5 and 25.0 minutes (P =0.044) for layered and mass closures, respectively.
CONCLUSIONS


Layered closure of upper abdominal transverse incisions should be preferred due to lower risk of incisional-SSIs and higher SWLR, despite clinically irrelevant longer duration.",2021,Layered technique was independently associated with fewer incisional-SSIs (OR: 0.29,"['Upper Abdominal Transverse Incisions', 'Patients undergoing laparotomy through upper abdominal transverse incisions', '268 patients were randomized to either mass (n=134) or layered (n=134) closure']","['Incisional surgical site infection (incisional-SSI', 'mass or layered closure with continuous sutures']","['Dehiscence', 'Incisional Surgical Site Infections', 'incisional-SSIs', 'Incisional-SSIs', 'Median SWLR', 'suture-to-wound length ratio (SWLR), closure duration, and fascial dehiscence (clinicatrials.gov NCT03561727']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1293123', 'cui_str': 'Layered closure - action'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}]",268.0,0.164009,Layered technique was independently associated with fewer incisional-SSIs (OR: 0.29,"[{'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Grąt', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Morawski', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Krasnodębski', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Borkowski', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Krawczyk', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Grąt', 'Affiliation': 'Second Department of Clinical Radiology, Warsaw, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stypułkowski', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Maczkowski', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Figiel', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Lewandowski', 'Affiliation': 'Department of Epidemiology and Biostatistics, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Kobryń', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Patkowski', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Krawczyk', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Wróblewski', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Włodzimierz', 'Initials': 'W', 'LastName': 'Otto', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Paluszkiewicz', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Zieniewicz', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Warsaw, Poland.'}]",Annals of surgery,['10.1097/SLA.0000000000005128']
977,34319468,Impact of Self-Monitoring on Weight Loss After Bariatric Surgery.,"BACKGROUND


Weight loss after bariatric surgery varies among patients. Patients who do not comply with self-monitoring are predicted to lose less weight than those who comply with self-monitoring.
OBJECTIVE


To assess the effect of compliance with self-monitoring behavior on long-term %excess weight loss (%EWL) and %total weight loss (%TWL) among patients receiving laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB).
METHODS


We used retrospective analysis to evaluate the self-monitoring behavior of patients and their weight changes throughout a 2-year follow-up. The participants were divided into two groups: group 1 consisted of participants who kept self-monitoring behavior records for all follow-ups and group 2 consisted of participants who kept self-monitoring behavior records for only six months of follow-up. Our investigators used telephone interviews to collect the data. By comparing %EWL and %TWL, we assessed the possible relationship between the long-term self-monitoring behavior, weight loss outcome, and operation type.
RESULTS


There were 384 included samples. %EWL was significantly different between group 1 and group 2, and group 1 participants had better outcomes regardless of operational method. In group 2, LRYGB patients had better %EWL outcomes than LSG patients.
CONCLUSIONS


Patients with long-term self-monitoring behaviors have better %EWL and %TWL. Patients in LRYGB group had better weight loss outcomes than the LSG group.",2021,"%EWL was significantly different between group 1 and group 2, and group 1 participants had better outcomes regardless of operational method.","['patients receiving', 'patients']","['participants who kept self-monitoring behavior records for all follow-ups and group 2 consisted of participants who kept self-monitoring behavior records for only six months of follow-up', 'laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB', 'Self-Monitoring', 'LSG']","['Weight Loss', 'total weight loss', 'weight loss outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0187169,"%EWL was significantly different between group 1 and group 2, and group 1 participants had better outcomes regardless of operational method.","[{'ForeName': 'Xinke', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Gynaecology and Obstetrics, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China. 362491585@qq.com.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Shuqing', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Cunchuan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Wah', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China. yangwah@qq.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obesity surgery,['10.1007/s11695-021-05600-w']
978,34319398,Extrapolating Long-term Event-Free and Overall Survival With Dapagliflozin in Patients With Heart Failure and Reduced Ejection Fraction: An Exploratory Analysis of a Phase 3 Randomized Clinical Trial.,"Importance


Sodium glucose cotransporter 2 inhibitors reduce morbidity and mortality in patients with heart failure and reduced ejection fraction (HFrEF). Clinicians may find estimates of the projected long-term benefits of sodium glucose cotransporter 2 inhibitors a helpful addition to clinical trial results when communicating the benefits of this class of drug to patients.
Objective


To estimate the projected long-term treatment effects of dapagliflozin in patients with HFrEF over the duration of a patient's lifetime.
Design, Setting, and Participants


Exploratory analysis was performed of Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF), a phase 3 randomized, placebo-controlled clinical trial conducted at 410 sites in 20 countries. Patients with an ejection fraction less than or equal to 40% in New York Heart Association functional classification II to IV and elevated plasma levels of N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019. Mean (SD) duration of follow-up was 17.6 (5.2) months.
Interventions


Dapagliflozin, 10 mg, once daily vs placebo in addition to standard therapy.
Main Outcomes and Measures


The primary composite outcome was time to first hospitalization for heart failure, urgent heart failure visit requiring intravenous therapy, or cardiovascular death. The trial results were extrapolated to estimate the projected long-term treatment effects of dapagliflozin over the duration of a patient's lifetime for the primary outcome and the secondary outcome of death from any cause.
Results


A total of 4744 patients (1109 women [23.4%]; 3635 men [76.6%]) were randomized in DAPA-HF, with a mean (SD) age of 66.3 (10.9) years. The extrapolated mean event-free survival for an individual aged 65 years from a primary composite end point event was 6.2 years for placebo and 8.3 years for dapagliflozin, representing an event-free survival time gain of 2.1 years (95% CI, 0.8-3.3 years; P = .002). When considering death from any cause, mean extrapolated life expectancy for an individual aged 65 years was 9.1 years for placebo and 10.8 years for dapagliflozin, with a gain in survival of 1.7 years (95% CI, 0.1-3.3; P = .03) with dapagliflozin. Similar results were seen when extrapolated across the age range studied. In analyses of subgroups of patients in DAPA-HF, consistent benefits were seen with dapagliflozin on both event-free and overall survival.
Conclusions and Relevance


These findings indicate that dapagliflozin provides clinically meaningful gains in extrapolated event-free and overall survival. These findings may be helpful in communicating the benefits of this treatment to patients with HFrEF.
Trial Registration


ClinicalTrials.gov Identifier: NCT03036124.",2021,"The extrapolated mean event-free survival for an individual aged 65 years from a primary composite end point event was 6.2 years for placebo and 8.3 years for dapagliflozin, representing an event-free survival time gain of 2.1 years (95% CI, 0.8-3.3 years; P = .002).","['Patients with an ejection fraction less than or equal to 40% in New York Heart Association functional classification II to IV and elevated plasma levels of N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019', '4744 patients (1109 women [23.4%]; 3635 men [76.6%]) were randomized in DAPA-HF, with a mean (SD) age of 66.3 (10.9) years', '410 sites in 20 countries', ""patients with HFrEF over the duration of a patient's lifetime"", 'Patients With Heart Failure and Reduced Ejection Fraction', 'patients with heart failure and reduced ejection fraction (HFrEF', 'patients with HFrEF']","['Dapagliflozin, 10 mg, once daily vs placebo', 'Sodium glucose cotransporter 2 inhibitors', 'Dapagliflozin', 'dapagliflozin', 'placebo']","['time to first hospitalization for heart failure, urgent heart failure visit requiring intravenous therapy, or cardiovascular death', 'survival time gain', 'Mean (SD) duration', 'extrapolated mean event-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",4744.0,0.731686,"The extrapolated mean event-free survival for an individual aged 65 years from a primary composite end point event was 6.2 years for placebo and 8.3 years for dapagliflozin, representing an event-free survival time gain of 2.1 years (95% CI, 0.8-3.3 years; P = .002).","[{'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2021.2632']
979,34319362,Extrapolating Survival From Randomized Clinical Trial Data-Possibilities and Caution.,,2021,,[],[],[],[],[],[],,0.560159,,"[{'ForeName': 'Laine Elliott', 'Initials': 'LE', 'LastName': 'Thomas', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Navar', 'Affiliation': 'Department of Cardiology, University of Texas Southwestern Medical School, Dallas.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Pencina', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}]",JAMA cardiology,['10.1001/jamacardio.2021.2629']
980,34315990,Impacts of treatments on recurrence and 28-year survival of ischemic stroke patients.,"Aspirin and nicametate are well-established therapies for preventing recurrence and mortality from stroke in patients diagnosed as ischemic stroke. However, their respective effects on the recurrence, making allowance for the duration of recurrence and death without the occurrence of recurrence, and long-term survival have not been well elucidated. We aimed to evaluate long-term effect of two kinds of treatment on cerebrovascular death among ischemic stroke patients with or without the recurrence of stroke. Data used in this study were derived from the cohort based on a multicenter randomized double-blind controlled trial during 1992 to 1995 with the enrollment of a total of 466 patients with first-time non-cardioembolic ischemic stroke who were randomly allocated to receive aspirin (n = 222) or nicametate (n = 244). The trial cohort was followed up over time to ascertain the date of recurrence within trial period and death until Sep of 2019. The time-dependent Cox regression model was used to estimate the long-term effects of two treatments on death from cerebrovascular disease with and without recurrence. A total of 49 patients experienced stroke recurrence and 89 cerebrovascular deaths was confirmed. Patients treated with nicametate were more likely, but non statistically significantly, to have recurrence (aHR: 1.73, 95% CI 0.96-3.13) as compared with those treated by aspirin. Nicametate reduced the risk of cerebrovascular death about 37% (aHR: 0.63, 95% CI 0.41-0.97) compared with aspirin. The aspirin group had a lower recurrence rate than the nicametate group even with recurrence after 1-2 years of follow-up of first stroke but the latter had significantly reduced death from cerebrovascular disease for nicametate group, which requires more research to verify.",2021,"The aspirin group had a lower recurrence rate than the nicametate group even with recurrence after 1-2 years of follow-up of first stroke but the latter had significantly reduced death from cerebrovascular disease for nicametate group, which requires more research to verify.","['1992 to 1995 with the enrollment of a total of 466 patients with first-time non-cardioembolic ischemic stroke', 'ischemic stroke patients', 'patients diagnosed as ischemic stroke', 'ischemic stroke patients with or without the recurrence of stroke']","['aspirin', 'Aspirin', 'nicametate']","['recurrence and 28-year survival', 'risk of cerebrovascular death', 'cerebrovascular death', 'recurrence rate', 'stroke recurrence and 89 cerebrovascular deaths']","[{'cui': 'C0456592', 'cui_str': '1992'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0068677', 'cui_str': 'nicametate'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",466.0,0.132415,"The aspirin group had a lower recurrence rate than the nicametate group even with recurrence after 1-2 years of follow-up of first stroke but the latter had significantly reduced death from cerebrovascular disease for nicametate group, which requires more research to verify.","[{'ForeName': 'Ting-Ann', 'Initials': 'TA', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Tzy-Haw', 'Initials': 'TH', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shin-Liang', 'Initials': 'SL', 'LastName': 'Pan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsiu-Hsi', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Sherry Yueh-Hsia', 'Initials': 'SY', 'LastName': 'Chiu', 'Affiliation': 'Department of Health Care Management, College of Management, and Healthy Aging Research Center, Chang Gung University, No. 259, Wenhua 1st Rd., Guishan Dist., Taoyuan City, 33302, Taiwan. sherrychiu@mail.cgu.edu.tw.'}]",Scientific reports,['10.1038/s41598-021-94757-6']
981,34324027,Effect of Endoscopic Appendix Intubation and Irrigation on Acute Uncomplicated Appendicitis.,"OBJECTIVE


To investigate the efficacy and safety of endoscopic appendix intubation and irrigation (EAI) on acute uncomplicated appendicitis.
METHODS


This prospective non-randomized study examined 169 patients with suspected acute uncomplicated appendicitis at The First Affiliated Hospital of Fujian Medical University from October 2015 to 2017. Patients were divided into three groups: endoscopic appendix intubation and irrigation (EAI, n = 18), laparoscopic appendectomy (LA, n = 87), and antibiotic alone (A, n = 64). The treatment success rate, duration of hospitalization, medical costs, operation time, duration of abdominal pain, fasting time, complications, and recurrence were analyzed.
RESULTS


The three groups had no significant differences in baseline characteristics (age, gender, Alvarado score, white blood cell count, and neutrophil count; all P > 0.05). Compared to the LA group, the EAI group had shorter durations of the operation, fasting, and abdominal pain; less use of oral and intravenous antibiotics; and lower medical costs (all P < 0.05). Compared to the A group, the EAI group had shorter durations of abdominal pain and hospitalization, and less use of intravenous antibiotics (all P < 0.05). The EAI group had no complications, but 3 patients (3.4%) in the LA group had surgery-related complications.
CONCLUSION


EAI is a safe and effective treatment for acute uncomplicated appendicitis. Patients who received EAI had shorter durations of abdominal pain and hospitalization than those who received LA or conservative antibiotic treatment.
TRIAL REGISTRATION NUMBER AND AGENCY


ChiCTR-IPN-15006565, Chinese Clinical Trial Registry.",2021,"The EAI group had no complications, but 3 patients (3.4%) in the LA group had surgery-related complications.
","['acute uncomplicated appendicitis', '169 patients with suspected acute uncomplicated appendicitis at The First Affiliated Hospital of Fujian Medical University from October 2015 to 2017', 'Acute Uncomplicated Appendicitis']","['Endoscopic Appendix Intubation and Irrigation', 'endoscopic appendix intubation and irrigation (EAI', 'EAI', 'LA', 'endoscopic appendix intubation and irrigation (EAI, n\u2009=\u200918), laparoscopic appendectomy (LA, n\u2009=\u200987), and antibiotic alone']","['shorter durations of abdominal pain and hospitalization', 'baseline characteristics (age, gender, Alvarado score, white blood cell count, and neutrophil count', 'shorter durations of the operation, fasting, and abdominal pain; less use of oral and intravenous antibiotics; and lower medical costs', 'treatment success rate, duration of hospitalization, medical costs, operation time, duration of abdominal pain, fasting time, complications, and recurrence', 'shorter durations of abdominal pain and hospitalization, and less use of intravenous antibiotics']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0003617', 'cui_str': 'Appendix structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",169.0,0.0522477,"The EAI group had no complications, but 3 patients (3.4%) in the LA group had surgery-related complications.
","[{'ForeName': 'Pei-Hong', 'Initials': 'PH', 'LastName': 'Zhang', 'Affiliation': 'The Endoscope Center, The First Afilliated Hospital of Fujian Medical University, No.20, Chazhong road, Taijiang District, Fuzhou, 350005, China.'}, {'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Wei', 'Affiliation': 'The Endoscope Center, The First Afilliated Hospital of Fujian Medical University, No.20, Chazhong road, Taijiang District, Fuzhou, 350005, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Lian', 'Affiliation': 'The Endoscope Center, The First Afilliated Hospital of Fujian Medical University, No.20, Chazhong road, Taijiang District, Fuzhou, 350005, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The Endoscope Center, The First Afilliated Hospital of Fujian Medical University, No.20, Chazhong road, Taijiang District, Fuzhou, 350005, China.'}, {'ForeName': 'Ze-Hao', 'Initials': 'ZH', 'LastName': 'Zhuang', 'Affiliation': 'The Endoscope Center, The First Afilliated Hospital of Fujian Medical University, No.20, Chazhong road, Taijiang District, Fuzhou, 350005, China. zehaozhuang@fjmu.edu.cn.'}]",World journal of surgery,['10.1007/s00268-021-06258-2']
982,34331403,Effects of the Mediterranean Diet or Nut Consumption on Gut Microbiota Composition and Fecal Metabolites and their Relationship with Cardiometabolic Risk Factors.,"SCOPE


To examine whether a Mediterranean Diet (MedDiet) compared to the consumption of nuts in the context of a habitual non-MedDiet exerts a greater beneficial effect on gut microbiota and fecal metabolites; thus, contributing to explain major benefits on cardiometabolic risk factors.
METHODS AND RESULTS


Fifty adults with Metabolic Syndrome are randomized to a controlled, crossover 2-months dietary-intervention trial with a 1-month wash-out period, following a MedDiet or consuming nuts (50 g day -1  ). Microbiota composition is assessed by 16S rRNA gene sequencing and metabolites are measured using Nuclear Magnetic Resonance (NMR) and liquid chromatography coupled to triple quadrupole mass spectrometry (LC-qTOF) platforms in a targeted metabolomics approach. Decreased glucose, insulin and the homeostatic model assessment of insulin resistance (HOMA-IR) is observed after the MedDiet compared to the nuts intervention. Relative abundances of Lachnospiraceae NK4A136 and an uncultured genera of Ruminococcaceae are significantly increased after the MedDiet compared to nuts supplementation. Changes in Lachnospiraceae NK4A136 are inversely associated with insulin levels and HOMA-IR, while positively and negatively with changes in cholate and cadaverine, respectively.
CONCLUSIONS


Following a MedDiet, rather than nuts, induces a significant increase in Lachnospiraceae NK4A136 and improves the metabolic risk. This genera seems to affect the bile acid metabolism and cadaverine which may account for the improvement in insulin levels.",2021,"Changes in Lachnospiraceae NK4A136 were inversely associated with insulin levels and HOMA-IR, while positively and negatively with changes in cholate and cadaverine, respectively.
",['Fifty adults with Metabolic Syndrome'],"['Mediterranean Diet (MedDiet', 'MedDiet or consuming nuts', 'Mediterranean Diet or Nut Consumption']","['Relative abundances of Lachnospiraceae NK4A136\xa0and un uncultured genera of Ruminococcaceae', 'Lachnospiraceae NK4A136', 'metabolic risk', 'Microbiota composition', 'Decreased glucose, insulin and HOMA-IR', 'insulin levels and HOMA-IR', 'Gut Microbiota Composition and Fecal Metabolites']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",50.0,0.0383033,"Changes in Lachnospiraceae NK4A136 were inversely associated with insulin levels and HOMA-IR, while positively and negatively with changes in cholate and cadaverine, respectively.
","[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Galié', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'García-Gavilán', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Camacho-Barcía', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Atzeni', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Jananee', 'Initials': 'J', 'LastName': 'Muralidharan', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Papandreou', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Arcelin', 'Affiliation': 'IISPV, Institute of Health Pere Virgily, Reus, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Palau-Galindo', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': ""ABS Alt Camp Oest. Centre d'Atenció Primària Alcover, Spain.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Basora', 'Affiliation': 'Tarragona-Reus Research Support Unit, Jordi Gol University Institute for Primary Care Research, Tarragona, 43202, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Arias-Vasquez', 'Affiliation': 'Department of Psychiatry, Radboudumc, Cognition and Behaviour, Donders Institute for Brain, Nijmegen, GA, 6525, The Netherlands.'}, {'ForeName': 'Mònica', 'Initials': 'M', 'LastName': 'Bulló', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000982']
983,34337074,Application and Clinical Effectiveness of Antibiotic-Loaded Bone Cement to Promote Soft Tissue Granulation in the Treatment of Neuropathic Diabetic Foot Ulcers Complicated by Osteomyelitis: A Randomized Controlled Trial.,"This study explored the clinical effectiveness of antibiotic-loaded bone cement on primary treatment of diabetic foot infection. This is a randomized controlled study, including thirty-six patients with diabetic foot ulcer complicated by osteomyelitis who had undergone treatment between May 2018 and December 2019. Patients were randomly divided into control group (group A) and study group (group B). Patients in the intervention group received antibiotic-loaded bone cement repair as primary treatment, while patients in the control group received conventional vacuum sealing draining treatment. Clinical endpoints were assessed and compared between the two groups, including wound healing time, wound bacterial conversion, NRS pain score, number of wound dressing changes, and average hospitalization time. All patients were followed up for a period of 12 months after discharge. Results show that compared with the control group, patients in the study group had significant difference in the number of patients for baseline pathogens eradication, short NRS pain score, hospital length of stay and cost, wound surface reduction, healing time, low rate of complications, and infection recurrence. Based on the findings, we conclude that antibiotic-loaded bone cement can be used for treatment of wound in patient with diabetic foot infection. It can help to control wound infections, shorten hospital length of stay, reduce medical cost, and relieve both doctors' and patients' burden. The application of antibiotic-loaded bone cement is suitable for diabetic wound with soft tissue infection or osteomyelitis.",2021,"Clinical endpoints were assessed and compared between the two groups, including wound healing time, wound bacterial conversion, NRS pain score, number of wound dressing changes, and average hospitalization time.","['diabetic foot infection', 'Neuropathic Diabetic Foot Ulcers', 'patient with diabetic foot infection', 'diabetic wound with soft tissue infection or osteomyelitis', 'thirty-six patients with diabetic foot ulcer complicated by osteomyelitis who had undergone treatment between May 2018 and December 2019']","['antibiotic-loaded bone cement', 'antibiotic-loaded bone cement repair', 'conventional vacuum sealing draining treatment', 'Antibiotic-Loaded Bone Cement']","['hospital length of stay, reduce medical cost, and relieve both doctors', 'wound healing time, wound bacterial conversion, NRS pain score, number of wound dressing changes, and average hospitalization time', 'number of patients for baseline pathogens eradication, short NRS pain score, hospital length of stay and cost, wound surface reduction, healing time, low rate of complications, and infection recurrence']","[{'cui': 'C0744130', 'cui_str': 'Diabetic foot infection'}, {'cui': 'C0406526', 'cui_str': 'Neuropathic ulcer of foot due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4728046', 'cui_str': 'Diabetic wound'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",36.0,0.0208343,"Clinical endpoints were assessed and compared between the two groups, including wound healing time, wound bacterial conversion, NRS pain score, number of wound dressing changes, and average hospitalization time.","[{'ForeName': 'Regis Ernest', 'Initials': 'RE', 'LastName': 'Mendame Ehya', 'Affiliation': 'Department of Orthopedics Trauma and Microsurgery, Zhongnan Hospital of Wuhan University, Wuhan, 430071 Hubei, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics Trauma and Microsurgery, Zhongnan Hospital of Wuhan University, Wuhan, 430071 Hubei, China.'}, {'ForeName': 'Baiwen', 'Initials': 'B', 'LastName': 'Qi', 'Affiliation': 'Department of Orthopedics Trauma and Microsurgery, Zhongnan Hospital of Wuhan University, Wuhan, 430071 Hubei, China.'}, {'ForeName': 'Aixi', 'Initials': 'A', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics Trauma and Microsurgery, Zhongnan Hospital of Wuhan University, Wuhan, 430071 Hubei, China.'}]",Journal of diabetes research,['10.1155/2021/9911072']
984,34335465,"Relacorilant, a Selective Glucocorticoid Receptor Modulator, Induces Clinical Improvements in Patients With Cushing Syndrome: Results From A Prospective, Open-Label Phase 2 Study.","Introduction/Purpose


Relacorilant is a selective glucocorticoid receptor modulator (SGRM) with no progesterone receptor activity. We evaluated the efficacy and safety of relacorilant in patients with endogenous Cushing syndrome (CS).
Materials and Methods


A single-arm, open-label, phase 2, dose-finding study with 2 dose groups (NCT02804750, https://clinicaltrials.gov/ct2/show/NCT02804750) was conducted at 19 sites in the U.S. and Europe. Low-dose relacorilant (100-200 mg/d; n = 17) was administered for 12 weeks or high-dose relacorilant (250-400 mg/d; n = 18) for 16 weeks; doses were up-titrated by 50 mg every 4 weeks. Outcome measures included proportion of patients with clinically meaningful changes in hypertension and/or hyperglycemia from baseline to last observed visit. For patients with hypertension, clinical response was defined as a ≥5-mmHg decrease in mean systolic or diastolic blood pressure, measured by a standardized and validated 24-h ABPM. For patients with hyperglycemia, clinical response was defined ad-hoc as ≥0.5% decrease in HbA1c, normalization or ≥50-mg/dL decrease in 2-h plasma glucose value on oral glucose tolerance test, or decrease in daily insulin (≥25%) or sulfonylurea dose (≥50%).
Results


35 adults with CS and hypertension and/or hyperglycemia (impaired glucose tolerance or type 2 diabetes mellitus) were enrolled, of which 34 (24 women/10 men) received treatment and had postbaseline data. In the low-dose group, 5/12 patients (41.7%) with hypertension and 2/13 patients (15.4%) with hyperglycemia achieved response. In the high-dose group, 7/11 patients (63.6%) with hypertension and 6/12 patients (50%) with hyperglycemia achieved response. Common (≥20%) adverse events included back pain, headache, peripheral edema, nausea, pain at extremities, diarrhea, and dizziness. No drug-induced vaginal bleeding or hypokalemia occurred.
Conclusions


The SGRM relacorilant provided clinical benefit to patients with CS without undesirable antiprogesterone effects or drug-induced hypokalemia.",2021,"No drug-induced vaginal bleeding or hypokalemia occurred.
","['35 adults with CS and hypertension and/or hyperglycemia (impaired glucose tolerance or type 2 diabetes mellitus) were enrolled, of which 34 (24 women/10 men) received treatment and had postbaseline data', 'patients with endogenous Cushing syndrome (CS', 'Patients With Cushing Syndrome']",['relacorilant'],"['proportion of patients with clinically meaningful changes in hypertension and/or hyperglycemia', 'hyperglycemia achieved response', 'efficacy and safety', 'vaginal bleeding or hypokalemia', 'mean systolic or diastolic blood pressure', 'back pain, headache, peripheral edema, nausea, pain at extremities, diarrhea, and dizziness', 'HbA1c, normalization or ≥50-mg/dL decrease in 2-h plasma glucose value on oral glucose tolerance test, or decrease in daily insulin']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0010481', 'cui_str': ""Cushing's syndrome""}]","[{'cui': 'C4743554', 'cui_str': 'relacorilant'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",35.0,0.0245692,"No drug-induced vaginal bleeding or hypokalemia occurred.
","[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Pivonello', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università Federico II di Napoli, Naples, Italy.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Bancos', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Feelders', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Atil Y', 'Initials': 'AY', 'LastName': 'Kargi', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes and Metabolism, University of Miami, Miami, FL, United States.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Kerr', 'Affiliation': 'Department of Endocrinology, Division of Endocrinology, Metabolism and Diabetes, University of Colorado Denver, Aurora, CO, United States.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Gordon', 'Affiliation': 'Allegheny Neuroendocrinology Center, Allegheny General Hospital, Pittsburgh, PA, United States.'}, {'ForeName': 'Cary N', 'Initials': 'CN', 'LastName': 'Mariash', 'Affiliation': 'Methodist Research Institute, Indiana University School of Medicine, Indianapolis, IN, United States.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Terzolo', 'Affiliation': 'Department of Clinical and Biological Sciences, Internal Medicine 1 - San Luigi Gonzaga Hospital, University of Turin, Orbassano, Italy.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Ellison', 'Affiliation': 'Biostatistics, Trialwise, Inc, Houston, TX, United States.'}, {'ForeName': 'Andreas G', 'Initials': 'AG', 'LastName': 'Moraitis', 'Affiliation': 'Drug Research and Development, Corcept Therapeutics, Menlo Park, CA, United States.'}]",Frontiers in endocrinology,['10.3389/fendo.2021.662865']
985,34333555,Neuroimaging correlates and predictors of response to repeated-dose intravenous ketamine in PTSD: preliminary evidence.,"Promising initial data indicate that the glutamate N-methyl-D-aspartate (NMDA) receptor antagonist ketamine may be beneficial in post-traumatic stress disorder (PTSD). Here, we explore the neural correlates of ketamine-related changes in PTSD symptoms, using a rich battery of functional imaging data (two emotion-processing tasks and one task-free scan), collected from a subset of participants of a randomized clinical trial of repeated-dose intravenous ketamine vs midazolam (total N = 21). In a pre-registered analysis, we tested whether changes in an a priori set of imaging measures from a target neural circuit were predictive of improvement in PTSD symptoms, using leave-one-out cross-validated elastic-net regression models (regions of interest in the target circuit consisted of the dorsal and rostral anterior cingulate cortex, ventromedial prefrontal cortex, anterior hippocampus, anterior insula, and amygdala). Improvements in PTSD severity were associated with increased functional connectivity between the ventromedial prefrontal cortex (vmPFC) and amygdala during emotional face-viewing (change score retained in model with minimum predictive error in left-out subjects, standardized regression coefficient [β] = 2.90). This effect was stronger in participants who received ketamine compared to midazolam (interaction β = 0.86), and persisted following inclusion of concomitant change in depressive symptoms in the analysis model (β = 0.69). Improvement following ketamine was also predicted by decreased dorsal anterior cingulate activity during emotional conflict regulation, and increased task-free connectivity between the vmPFC and anterior insula (βs = -2.82, 0.60). Exploratory follow-up analysis via dynamic causal modelling revealed that whilst improvement in PTSD symptoms following either drug was associated with decreased excitatory modulation of amygdala→vmPFC connectivity during emotional face-viewing, increased top-down inhibition of the amygdala by the vmPFC was only observed in participants who improved under ketamine. Individuals with low prefrontal inhibition of amygdala responses to faces at baseline also showed greater improvements following ketamine treatment. These preliminary findings suggest that, specifically under ketamine, improvements in PTSD symptoms are accompanied by normalization of hypofrontal control over amygdala responses to social signals of threat.",2021,"Improvement following ketamine was also predicted by decreased dorsal anterior cingulate activity during emotional conflict regulation, and increased task-free connectivity between the vmPFC and anterior insula (βs = -2.82, 0.60).",['PTSD'],"['glutamate N-methyl-D-aspartate (NMDA) receptor antagonist ketamine', 'ketamine vs midazolam', 'ketamine', 'midazolam']","['dorsal anterior cingulate activity during emotional conflict regulation, and increased task-free connectivity', 'functional connectivity between the ventromedial prefrontal cortex (vmPFC) and amygdala during emotional face-viewing', 'PTSD symptoms']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.131609,"Improvement following ketamine was also predicted by decreased dorsal anterior cingulate activity during emotional conflict regulation, and increased task-free connectivity between the vmPFC and anterior insula (βs = -2.82, 0.60).","[{'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Norbury', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Rutter', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Abigail B', 'Initials': 'AB', 'LastName': 'Collins', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Costi', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Horn', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Kautz', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Corniquel', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Glasgow', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Brallier', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Shin', 'Affiliation': 'Department of Psychology, Tufts University, Medford, MA, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Charney', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Feder', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA. adriana.feder@mssm.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01104-4']
986,34333190,Disease-Modifying Effect of Japanese Cedar Pollen Sublingual Immunotherapy Tablets.,"BACKGROUND


Japanese cedar (JC) pollinosis is a common allergic rhinitis in Japan. JC pollen sublingual immunotherapy (SLIT) tablets are licensed for the treatment of JC pollinosis.
OBJECTIVE


To assess the disease-modifying effects of JC pollen SLIT tablets over 5 years (2014-2019), comprising a 3-year treatment period and 2-year follow-up.
METHODS


A total of 1042 patients with JC pollinosis (aged 5-64 years) were included in the study. An optimal dose-finding study was performed in the first 15 months, after which 240 patients in the placebo (P) group and 236 patients in the optimal active dose (A) group (5000 Japanese allergy units) were re-randomized to receive P or A for an additional 18 months (designated AA, AP, PA, and PP groups). Clinical efficacy was evaluated by the total nasal symptom and medication score (TNSMS) during the peak symptom period of each JC pollen season over 3 years of treatment and 2 years of observation after treatment cessation.
RESULTS


The AA, AP, and PA groups exhibited significantly reduced TNSMS; however, the largest relative reduction was seen in the AA group both during the treatment period (third season, 46.3% vs PP, P < .001) and during the 2-year follow-up period (fourth and fifth seasons, 45.3% and 34.0% vs PP, respectively; P < .001). The most common adverse drug reactions were mild reactions at the administration site.
CONCLUSIONS


JC pollen SLIT tablets show sustained clinical efficacy during 3 years of treatment and sustained disease-modifying effects for at least 2 years after treatment cessation.",2021,"The AA, AP, and PA groups exhibited significantly reduced TNSMS; however the largest relative reduction was seen in the AA group both during the treatment period (third season, 46.3% vs PP, P < .001) and during the 2-year follow-up period (fourth and fifth seasons, 45.3% and 34.0% vs PP, respectively; P < .001).","['240 patients in the placebo (P) group and 236 patients in the optimal active dose (A) group (5000 Japanese Allergy Units', '1042 patients with JC pollinosis (aged 5-64 years', 'Japanese cedar (JC) pollinosis is a common allergic rhinitis in Japan']","['JC pollen SLIT tablets', 'Japanese cedar pollen sublingual immunotherapy tablets', 'JC pollen sublingual immunotherapy (SLIT) tablets']","['Clinical efficacy', 'total nasal symptom and medication score (TNSMS', 'TNSMS']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0996622', 'cui_str': 'Cedar, Japanese'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0440380', 'cui_str': 'Japanese cedar pollen'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1042.0,0.0688914,"The AA, AP, and PA groups exhibited significantly reduced TNSMS; however the largest relative reduction was seen in the AA group both during the treatment period (third season, 46.3% vs PP, P < .001) and during the 2-year follow-up period (fourth and fifth seasons, 45.3% and 34.0% vs PP, respectively; P < .001).","[{'ForeName': 'Syuji', 'Initials': 'S', 'LastName': 'Yonekura', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan. Electronic address: syonekura@faculty.chiba-u.jp.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Department of Medical Affairs, Torii Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yuriko', 'Initials': 'Y', 'LastName': 'Maekawa', 'Affiliation': 'Department of Medical Affairs, Torii Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kimihiro', 'Initials': 'K', 'LastName': 'Okubo', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan; Chiba Rousai Hospital, Chiba, Japan.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2021.06.060']
987,34340917,Improvement in Dysphagia Outcomes Following Clinical Target Volume Reduction in the De-ESCALaTE Study.,"AIMS


The De-ESCALaTE study showed an overall survival advantage for the administration of synchronous cisplatin chemotherapy with radiotherapy in low-risk oropharyngeal cancer when compared with synchronous cetuximab. During the trial, a radiotherapy quality assurance protocol amendment permitted centres to swap from the original radiotherapy contouring protocol (incorporating the whole oropharynx into the high-dose clinical target volume (CTV); anatomical protocol) to a protocol that incorporated the gross tumour volume with a 10 mm margin into the CTV (volumetric protocol). The purpose of this study was to examine both toxicity and tumour control related to this protocol amendment.
MATERIALS AND METHODS


Overall survival and recurrence at 2 years were used to compare tumour control in the two contouring cohorts. For toxicity, the cohorts were compared by both the number of severe (grades 3-5) and all grades acute and late toxicities. In addition, quality of life and swallowing were compared using EORTC-C30 and MD Anderson Dysphagia Inventory, respectively.
RESULTS


Of 327 patients included in this study, 185 were contoured according to the anatomical protocol and 142 by the volumetric protocol. The two cohorts were well balanced, with the exception of significantly more patients in the anatomical cohort undergoing prophylactic feeding tube insertion (P < 0.001). With a minimum of 2 years of follow-up there was no significant difference in overall survival or recurrence between the two contouring protocols. Similarly, there was no significant difference in the rate of reported severe or all grades acute or late toxicity and no sustained significant difference in quality of life. However, there was a significant difference in favour of volumetric contouring in several domains of the MD Anderson Dysphagia Inventory questionnaire at 1 year, which persisted to 2 years in the dysphagia functional (P = 0.002), dysphagia physical (P = 0.009) and dysphagia overall function (P = 0.008) domains.
CONCLUSION


In the context of the unplanned post-hoc analysis of a randomised trial, measurable improvement in long-term dysphagia has been shown following a reduction in the CTV. Further reductions in the CTV should be subject to similar scrutiny within the confines of a prospective study.",2021,With a minimum of 2 years of follow-up there was no significant difference in overall survival or recurrence between the two contouring protocols.,"['327 patients included in this study, 185 were contoured according to the anatomical protocol and 142 by the volumetric protocol']",['synchronous cisplatin chemotherapy with radiotherapy'],"['low-risk oropharyngeal cancer', 'quality of life and swallowing', 'grades acute and late toxicities', 'dysphagia physical', 'Overall survival and recurrence', 'Dysphagia Outcomes', 'rate of reported severe or all grades acute or late toxicity', 'overall survival or recurrence', 'overall survival advantage', 'dysphagia functional', 'MD Anderson Dysphagia Inventory questionnaire', 'quality of life', 'dysphagia overall function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",327.0,0.0913898,With a minimum of 2 years of follow-up there was no significant difference in overall survival or recurrence between the two contouring protocols.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vreugdenhil', 'Affiliation': 'Hall-Edwards Radiotherapy Research Group, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fong', 'Affiliation': 'Hall-Edwards Radiotherapy Research Group, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Iqbal', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Roques', 'Affiliation': 'Norfolk and Norwich University Hospitals, Norwich, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'Velindre University NHS Trust, Cardiff, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Palaniappan', 'Affiliation': 'Velindre University NHS Trust, Cardiff, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': ""O'Toole"", 'Affiliation': 'Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sanghera', 'Affiliation': 'Hall-Edwards Radiotherapy Research Group, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nutting', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Foran', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sen', 'Affiliation': ""St James' Institute of Oncology, Leeds, UK.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Al Booz', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fulton-Lieuw', 'Affiliation': 'Institute of Head and Neck Studies and Education (InHANSE), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dalby', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hartley', 'Affiliation': 'Hall-Edwards Radiotherapy Research Group, Queen Elizabeth Hospital, Birmingham, UK. Electronic address: andrew.hartley@uhb.nhs.uk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mehanna', 'Affiliation': 'Institute of Head and Neck Studies and Education (InHANSE), University of Birmingham, Birmingham, UK.'}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2021.07.009']
988,34339231,Midodrine for the Prevention of Vasovagal Syncope : A Randomized Clinical Trial.,"BACKGROUND


Recurrent vasovagal syncope is common, responds poorly to treatment, and causes physical trauma and poor quality of life. Midodrine prevents hypotension and syncope during tilt tests in patients with vasovagal syncope.
OBJECTIVE


To determine whether midodrine can prevent vasovagal syncope in usual clinical conditions.
DESIGN


Randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT01456481).
SETTING


25 university hospitals in Canada, the United States, Mexico, and the United Kingdom.
PATIENTS


Patients with recurrent vasovagal syncope and no serious comorbid conditions.
INTERVENTION


Patients were randomly assigned 1:1 to placebo or midodrine and followed for 12 months.
MEASUREMENTS


The primary outcome measure was the proportion of patients with at least 1 syncope episode during follow-up.
RESULTS


The study included 133 patients who had had a median of 6 syncope episodes in the prior year (median age, 32 years; 73% female). Compared with patients receiving placebo, fewer patients receiving midodrine had at least 1 syncope episode (28 of 66 [42%] vs. 41 of 67 [61%]). The relative risk was 0.69 (95% CI, 0.49 to 0.97;  P  = 0.035). The absolute risk reduction was 19 percentage points (CI, 2 to 36 percentage points), and the number needed to treat to prevent 1 patient from having syncope was 5.3 (CI, 2.8 to 47.6). The time to first syncope was longer with midodrine (hazard ratio, 0.59 [CI, 0.37 to 0.96];  P  = 0.035; log-rank  P  = 0.031). Adverse effects were similar in both groups.
LIMITATION


Small study size, young and healthy patients, relatively short observation period, and high proportion of patients from 1 center.
CONCLUSION


Midodrine can reduce the recurrence of syncope in healthy, younger patients with a high syncope burden.
PRIMARY FUNDING SOURCE


The Canadian Institutes of Health Research.",2021,"The relative risk was 0.69 (95% CI, 0.49 to 0.97;  P  = 0.035).","['Patients with recurrent vasovagal syncope and no serious comorbid conditions', 'young and healthy patients, relatively short observation period, and high proportion of patients from 1 center', 'healthy, younger patients with a high syncope burden', '25 university hospitals in Canada, the United States, Mexico, and the United Kingdom', 'patients with vasovagal syncope', '133 patients who had had a median of 6 syncope episodes in the prior year (median age, 32 years; 73% female']","['Midodrine', 'placebo', 'midodrine', 'placebo or midodrine']","['Vasovagal Syncope ', 'number needed to treat to prevent 1 patient from having syncope', 'absolute risk reduction', 'time to first syncope', 'relative risk', 'syncope episode', 'recurrence of syncope', 'vasovagal syncope', 'proportion of patients with at least 1 syncope episode during follow-up', 'hypotension and syncope', 'Adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0042420', 'cui_str': 'Vasovagal syncope'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0026078', 'cui_str': 'Midodrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042420', 'cui_str': 'Vasovagal syncope'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",133.0,0.499846,"The relative risk was 0.69 (95% CI, 0.49 to 0.97;  P  = 0.035).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sheldon', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada (R.S., P.F., C.A.M., D.R., S.S., C.M.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Faris', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada (R.S., P.F., C.A.M., D.R., S.S., C.M.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada (A.T.).'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ayala-Paredes', 'Affiliation': 'University of Sherbrooke, Sherbrooke, Quebec, Canada (F.A.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Guzman', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada (J.G.).'}, {'ForeName': 'Manlio', 'Initials': 'M', 'LastName': 'Marquez', 'Affiliation': 'Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico (M.M.).'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada (R.S., P.F., C.A.M., D.R., S.S., C.M.).'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krahn', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada (A.D.K.).'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Kus', 'Affiliation': 'University of Montreal, Montreal, Quebec, Canada (T.K.).'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Ritchie', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada (R.S., P.F., C.A.M., D.R., S.S., C.M.).'}, {'ForeName': 'Shahana', 'Initials': 'S', 'LastName': 'Safdar', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada (R.S., P.F., C.A.M., D.R., S.S., C.M.).'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Maxey', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada (R.S., P.F., C.A.M., D.R., S.S., C.M.).'}, {'ForeName': 'Satish R', 'Initials': 'SR', 'LastName': 'Raj', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada, and Vanderbilt University School of Medicine, Nashville, Tennessee (S.R.R.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M20-5415']
989,34346168,"Population repeated time-to-event analysis of exacerbations in asthma patients: A novel approach for predicting asthma exacerbations based on biomarkers, spirometry, and diaries/questionnaires.","Identification of covariates, including biomarkers, spirometry, and diaries/questionnaires, that predict asthma exacerbations would allow better clinical predictions, shorter phase II trials and inform decisions on phase III design, and/or initiation (go/no-go). The objective of this work was to characterize asthma-exacerbation hazard as a function of baseline and time-varying covariates. A repeated time-to-event (RTTE) model for exacerbations was developed using data from a 52-week phase IIb trial, including 502 patients with asthma randomized to placebo or 70 mg, 210 mg, or 490 mg astegolimab every 4 weeks. Covariate analysis was performed for 20 baseline covariates using the full random effects modeling approach, followed by time-varying covariate analysis of nine covariates using the stepwise covariate model (SCM) building procedure. Following the SCM, an astegolimab treatment effect was explored. Diary-based symptom score (difference in objective function value [dOFV] of -83.7) and rescue medication use (dOFV = -33.5), and forced expiratory volume in 1 s (dOFV = -14.9) were identified as significant time-varying covariates. Of note, time-varying covariates become more useful with more frequent measurements, which should favor the daily diary scores over others. The most influential baseline covariates were exacerbation history and diary-based symptom score (i.e., symptom score was important as both time-varying and baseline covariate). A (nonsignificant) astegolimab treatment effect was included in the final model because the limited data set did not allow concluding the remaining effect size as irrelevant. Without time-varying covariates, the treatment effect was statistically significant (p < 0.01). This work demonstrated the utility of a population RTTE approach to characterize exacerbation hazard in patients with severe asthma.",2021,"Diary-based symptom score (difference in objective function value [dOFV] of -83.7) and rescue medication use (dOFV=-33.5), and forced expiratory volume in 1 second (dOFV=-14.9) were identified as significant time-varying covariates.","['asthma patients', '502 asthma patients randomized to', 'patients with severe asthma']",['placebo'],"['exacerbation history and diary-based symptom score', 'objective function value [dOFV] of -83.7) and rescue medication use (dOFV=-33.5), and forced expiratory volume in 1 second (dOFV=-14.9', 'Diary-based symptom score']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",502.0,0.21597,"Diary-based symptom score (difference in objective function value [dOFV] of -83.7) and rescue medication use (dOFV=-33.5), and forced expiratory volume in 1 second (dOFV=-14.9) were identified as significant time-varying covariates.","[{'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Svensson', 'Affiliation': 'Pharmetheus, Uppsala, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Ribbing', 'Affiliation': 'Pharmetheus, Uppsala, Sweden.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kotani', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dolton', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Vadhavkar', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Cheung', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Staton', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Choy', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Putnam', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Nageshwar', 'Initials': 'N', 'LastName': 'Budha', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Mats O', 'Initials': 'MO', 'LastName': 'Karlsson', 'Affiliation': 'Pharmetheus, Uppsala, Sweden.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Quartino', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12690']
990,34350598,Social status affects how third parties assess unfairly shared losses and unfairly shared gains.,"The present paper focused on how a third party's social status affects third-party intervention to maintain social fairness. Study 1 adopted a quasi-experimental design. Selecting high and low-status members of real social groups, we observed that high-status individuals intervened more forcibly and more frequently when assessing the fairness of players' behavior in a dictator game (DG). The manifestation of social status is generally divided into power and economic capital. In Study 2a, using the same DG punishment-compensation paradigm we randomly assigned the third party in the lab to high, medium, and low impact conditions, where their actions had relative multiplier effects on the resources retained by dictators and recipients. This tested whether the power to influence the situation would systematically affect third party's behavior. We found that greater influence predicted increased interventions. Study 2b investigated the influence of economic capital or intrinsic wealth on a third party's altruistic behavior by varying how much capital the third party had at their disposal to spend on punishment or recompensing. Having high capital predicted an increase in the size of penalty inflicted or compensation offered, but resource abundance had no effect on the likelihood that the third party would intervene. In conclusion, the paper showed that the social status of the third party truly does affect their altruistic interventions and the impact of social status on altruistic behaviors for maintaining fairness by the third party occurred primarily through the third parties' perception of their power. Furthermore, the influence of gain and loss contexts and social status on third-party punishment and compensation were independent of each other. This paper provided a new perspective for third-party altruistic behaviors and help to clarify the view of social fairness.",2021,"Having high capital predicted an increase in the size of penalty inflicted or compensation offered, but resource abundance had no effect on the likelihood that the third party would intervene.",[],[],[],[],[],[],,0.016276,"Having high capital predicted an increase in the size of penalty inflicted or compensation offered, but resource abundance had no effect on the likelihood that the third party would intervene.","[{'ForeName': 'Yingjie', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Psychology, North China University of Science and Technology, Tangshan, Hebei province, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'School of Psychology, North China University of Science and Technology, Tangshan, Hebei province, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'School of Psychology, North China University of Science and Technology, Tangshan, Hebei province, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Tian', 'Affiliation': 'Graduate student Department, Guangdong Polytechnic Normal University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Psychology, North China University of Science and Technology, Tangshan, Hebei province, China.'}, {'ForeName': 'Baxter', 'Initials': 'B', 'LastName': 'DiFabrizio', 'Affiliation': 'The College of William and Mary, Williamsburg, VA, USA.'}, {'ForeName': 'Yaozhong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Management, Jinan University, Guangzhou, Guangdong, China.'}]",Scandinavian journal of psychology,['10.1111/sjop.12764']
991,34368890,Multicenter phase II clinical study of the efficiency and safety of capecitabine plus intermittent oxaliplatin with bevacizumab as first-line therapy in patients with metastatic colorectal cancer (VOICE trial).,"PURPOSE


The aim of this phase II study was to evaluate the efficacy and safety of combination therapy with five-cycle CAPOX (capecitabine plus oxaliplatin) plus bevacizumab, followed by five-cycle maintenance therapy with capecitabine plus bevacizumab and reintroduction of CAPOX plus bevacizumab for five cycles, with a preplanned intermittent oxaliplatin strategy in metastatic colorectal cancer (mCRC).
METHODS


Patients with untreated mCRC were administered CAPOX (130 mg/m 2  oxaliplatin on day 1, 2000 mg/m 2 /day capecitabine on days 1-14, every 21 days) + bevacizumab (7.5 mg/kg) every 3 weeks for five cycles, maintenance treatment without oxaliplatin for five cycles, and CAPOX + bevacizumab reintroduction for five cycles or upon tumor progression. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were the time to treatment failure (TTF), overall survival, response rate (RR), and safety.
RESULTS


Forty-seven patients who fulfilled the inclusion criteria were enrolled in the evaluation of efficacy and safety. Median PFS was 14.1 months (95% confidence interval [CI], 8.6-19.5), and median TTF was 12.3 months (95% CI, 10.3-14.3). The objective RRs were 51.1% (24/47) during induction therapy, 58.3% (21/36) during maintenance therapy, and 63.6% (14/22) during reintroduction therapy. The frequency of patients with neutropenia, diarrhea, peripheral sensory neuropathy, venous thromboembolism, or grade ≥ 3 allergic reactions was 2.1%.
CONCLUSION


CAPOX plus bevacizumab therapy with a preplanned intermittent oxaliplatin strategy consisting of brief five-cycle induction therapy, five-cycle maintenance therapy with capecitabine plus bevacizumab, and five-cycle reintroduction therapy consisting of CAPOX plus bevacizumab is safe and effective for mCRC patients.
TRIAL REGISTRATION


UMIN ID: 000,005,732, date of registration: June 7, 2011.  https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000006695.",2021,"Median PFS was 14.1 months (95% confidence interval [CI], 8.6-19.5), and median TTF was 12.3 months (95% CI, 10.3-14.3).","['Patients with untreated mCRC', 'patients with metastatic colorectal cancer (VOICE trial', 'metastatic colorectal cancer (mCRC', 'Forty-seven patients who fulfilled the inclusion criteria']","['CAPOX plus bevacizumab', 'oxaliplatin', 'CAPOX\u2009+\u2009bevacizumab reintroduction', 'bevacizumab', 'capecitabine plus bevacizumab', 'CAPOX (130\xa0mg/m 2  oxaliplatin on day 1, 2000\xa0mg/m 2 /day capecitabine', 'capecitabine plus bevacizumab and reintroduction of CAPOX plus bevacizumab', 'capecitabine plus intermittent oxaliplatin with bevacizumab', 'combination therapy with five-cycle CAPOX (capecitabine plus oxaliplatin) plus bevacizumab']","['efficacy and safety', 'Median PFS', 'objective RRs', 'frequency of patients with neutropenia, diarrhea, peripheral sensory neuropathy, venous thromboembolism, or grade\u2009≥\u20093 allergic reactions', 'median TTF', 'progression-free survival (PFS', 'time to treatment failure (TTF), overall survival, response rate (RR), and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C4087167', 'cui_str': 'Tumour treating fields therapy'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",47.0,0.0653659,"Median PFS was 14.1 months (95% confidence interval [CI], 8.6-19.5), and median TTF was 12.3 months (95% CI, 10.3-14.3).","[{'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Kosugi', 'Affiliation': 'Department of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan. ckosugi0126@yahoo.co.jp.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Koda', 'Affiliation': 'Department of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Saitama, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Saitama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Seike', 'Affiliation': 'Department of Surgery, Odawara Municipal Hospital, Odawara, Kanagawa, Japan.'}, {'ForeName': 'Haruhito', 'Initials': 'H', 'LastName': 'Sakata', 'Affiliation': 'Department of Surgery, Saisei Hospital, Hanamigawa, Chiba, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yanagisawa', 'Affiliation': 'Department of Surgery, Kimitsu Chuo Hospital, Kisarazu, Chiba, Japan.'}, {'ForeName': 'Akinari', 'Initials': 'A', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Surgery, Funabashi Municipal Medical Center, Funabashi, Chiba, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Takayama', 'Affiliation': 'Department of Surgery, Chiba Prefectural Sawara Hospital, Sakura, Chiba, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Koike', 'Affiliation': 'Department of Surgery, Seirei Sakura Citizen Hospital, Sakura, Chiba, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Shimizu', 'Affiliation': 'Department of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.'}, {'ForeName': 'Hisahiro', 'Initials': 'H', 'LastName': 'Matsubara', 'Affiliation': 'Department of Frontier Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}]",International journal of colorectal disease,['10.1007/s00384-021-03995-7']
992,34364698,"Response to Letter Regarding Article, ""Effects of Ivermectin in Patients With COVID-19: A Multicenter, Double-Blind, Randomized, Controlled Clinical Trial"".",,2021,,['Patients With COVID-19'],['Ivermectin'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}]",[],,0.744735,,"[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Shahbaznejad', 'Affiliation': 'Pediatric Infectious Diseases Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Davoudi', 'Affiliation': 'Antimicrobial Resistance Research Center, Department of Infectious Diseases, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Gohar', 'Initials': 'G', 'LastName': 'Eslami', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Cardiovascular Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Markowitz', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, Center for Pharmacogenomics and Precision Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Navaeifar', 'Affiliation': 'Pediatric Infectious Diseases Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Pediatric Infectious Diseases Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Faeze Sadat', 'Initials': 'FS', 'LastName': 'Movahedi', 'Affiliation': 'Student Research Committee, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Rezai', 'Affiliation': 'Pediatric Infectious Diseases Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: drmsrezaii@yahoo.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2021.07.006']
993,34364670,Rate Versus Rhythm Control in Heart Failure Patients with Post-Operative Atrial Fibrillation After Cardiac Surgery.,"BACKGROUND


Whether rhythm control for post-operative atrial fibrillation after cardiac surgery (POAF) is superior to rate control in patients with heart failure or systolic dysfunction (HF) is not known.
METHODS


We performed a post-hoc analysis of a trial by the Cardiothoracic Surgical Trials Network, which randomized patients with POAF after cardiac surgery to rate control or rhythm control with amiodarone/cardioversion. We assessed subgroups of trial participants defined by heart failure/cardiomyopathy history or left ventricular ejection fraction (LVEF) < 50%. We conducted a stratified analysis in patients with and without HF to explore outcomes of rhythm versus rate control strategy.
RESULTS


Of 523 subjects with POAF after cardiac surgery, 131 (25%) had HF. 49% of HF patients were randomized to rhythm control. In HF patients, rhythm control was associated with less atrial fibrillation within the first 7 days. There were no differences in rhythm at 30- and 60-day follow-up. In the HF group, there were significantly more subjects with AF < 48 hours in the rhythm control group compared to rate control group- 68.8% compared to 46.3%, P=0.009. By comparison, in the non-HF stratum, 54.4% of the rate control group had AF < 48 hours compared to 63.5% of the rhythm control group (P=0.067).), though there was no significant interaction of heart failure with cardiac rhythm at 7 days (Pinteraction 0.16).
CONCLUSION


Rhythm control for HF patients with POAF after cardiac surgery increases early restoration of sinus rhythm. Rate and rhythm control are both reasonable for HF patients with AF after cardiac surgery.",2021,There were no differences in rhythm at 30- and 60-day follow-up.,"['subgroups of trial participants defined by heart failure/cardiomyopathy history or left ventricular ejection fraction (LVEF) < 50', 'patients with and without HF to explore outcomes of rhythm versus rate control strategy', 'patients with heart failure or systolic dysfunction (HF', 'Heart Failure Patients with Post-Operative Atrial Fibrillation', 'HF patients with AF after cardiac surgery', 'HF patients with POAF after cardiac surgery increases early restoration of sinus rhythm', '523 subjects with POAF after cardiac surgery, 131 (25%) had HF', 'patients with POAF after cardiac surgery to rate control or rhythm control with']","['amiodarone/cardioversion', 'cardiac surgery (POAF']","['Rate and rhythm control', 'heart failure with cardiac rhythm', 'atrial fibrillation']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",523.0,0.17815,There were no differences in rhythm at 30- and 60-day follow-up.,"[{'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, Department of Medicine Johns Hopkins University School of Medicine, Baltimore MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spragg', 'Affiliation': 'Division of Cardiology, Department of Medicine Johns Hopkins University School of Medicine, Baltimore MD.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Schulman', 'Affiliation': 'Division of Cardiology, Department of Medicine Johns Hopkins University School of Medicine, Baltimore MD.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Division of Cardiology, Department of Medicine Johns Hopkins University School of Medicine, Baltimore MD.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore MD.'}, {'ForeName': 'Rawn', 'Initials': 'R', 'LastName': 'Salenger', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Whitman', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore MD.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Metkus', 'Affiliation': 'Division of Cardiology, Department of Medicine Johns Hopkins University School of Medicine, Baltimore MD; Division of Cardiovascular Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore MD. Electronic address: tmetkus1@jhmi.edu.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2021.02.016']
994,34364665,Empagliflozin in Heart Failure With Predicted Preserved Versus Reduced Ejection Fraction: Data From the EMPA-REG OUTCOME Trial.,"BACKGROUND


In the EMPA-REG OUTCOME trial, ejection fraction (EF) data were not collected. In the subpopulation with heart failure (HF), we applied a new predictive model for EF to determine the effects of empagliflozin in HF with predicted reduced (HFrEF) vs preserved (HFpEF) EF vs no HF.
METHODS AND RESULTS


We applied a validated EF predictive model based on patient baseline characteristics and treatments to categorize patients with HF as being likely to have HF with mid-range EF (HFmrEF)/HFrEF (EF <50%) or HFpEF (EF ≥50%). Cox regression was used to assess the effect of empagliflozin vs placebo on cardiovascular death/HF hospitalization (HHF), cardiovascular and all-cause mortality, and HHF in patients with predicted HFpEF, HFmrEF/HFrEF and no HF. Of 7001 EMPA-REG OUTCOME patients with data available for this analysis, 6314 (90%) had no history of HF. Of the 687 with history of HF, 479 (69.7%) were predicted to have HFmrEF/HFrEF and 208 (30.3%) to have HFpEF. Empagliflozin's treatment effect was consistent in predicted HFpEF, HFmrEF/HFrEF and no-HF for each outcome (HR [95% CI] for the primary outcome 0.60 [0.31-1.17], 0.79 [0.51-1.23], and 0.63 [0.50-0.78], respectively; P interaction = 0.62).
CONCLUSIONS


In EMPA-REG OUTCOME, one-third of the patients with HF had predicted HFpEF. The benefits of empagliflozin on HF and mortality outcomes were consistent in nonHF, predicted HFpEF and HFmrEF/HFrEF.",2021,"The benefits of empagliflozin on HF and mortality outcomes were consistent in nonHF, predicted HFpEF and HFmrEF/HFrEF.","['Heart Failure', '687 with history of HF, 479 (69.7%) were predicted to have HFmrEF/HFrEF and 208 (30.3%) to have HFpEF', 'categorize patients with HF as being likely to have HF with mid-range EF (HFmrEF)/HFrEF (EF <50%) or HFpEF (EF ≥50', 'patients with data available for this analysis, 6314 (90%) had no history of HF', 'patients with predicted HFpEF, HFmrEF/HFrEF and no HF']","['empagliflozin vs placebo', 'Empagliflozin', 'empagliflozin']","['cardiovascular death/HF hospitalization (HHF), cardiovascular and all-cause mortality, and HHF', 'HF and mortality outcomes', 'HFpEF', 'predicted HFpEF, HFmrEF/HFrEF and no-HF']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332122', 'cui_str': 'No history of'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",,0.392637,"The benefits of empagliflozin on HF and mortality outcomes were consistent in nonHF, predicted HFpEF and HFmrEF/HFrEF.","[{'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Savarese', 'Affiliation': 'Division of Cardiology, Department of Medicine, Karolinska Institute, Stockholm, Sweden. Electronic address: gianluigi.savarese@ki.se.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Uijl', 'Affiliation': 'Division of Cardiology, Department of Medicine, Karolinska Institute, Stockholm, Sweden; Department of Cardiology, Division Heart & Lungs, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Institute of Cardiovascular Science, Faculty of Population Health Sciences, Health Data Research UK and Institute of Health Informatics, University College London, London, United Kingdom.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lund', 'Affiliation': 'Division of Cardiology, Department of Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Folkert', 'Initials': 'F', 'LastName': 'Asselbergs', 'Affiliation': 'Department of Cardiology, Division Heart & Lungs, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Institute of Cardiovascular Science, Faculty of Population Health Sciences, Health Data Research UK and Institute of Health Informatics, University College London, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""St Michael's Hospital, Division of Cardiology, University of Toronto, ON, Canada.""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Koudstaal', 'Affiliation': 'Department of Cardiology, Division Heart & Lungs, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Institute of Cardiovascular Science, Faculty of Population Health Sciences, Health Data Research UK and Institute of Health Informatics, University College London, London, United Kingdom.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway Ks, Asker, Norway.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schrage', 'Affiliation': 'Division of Cardiology, Department of Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Vedin', 'Affiliation': 'Boehringer Ingelheim AB, Stockholm, Sweden.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Institut Lorrain du Coeur et des Vaisseaux, Nancy, France.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2021.05.012']
995,34323437,Long-term Efficacy of Percutaneous Epidural Neurolysis of Adhesions in Chronic Lumbar Radicular Pain: 10 Year Follow-up of a Randomized Controlled Trial.,"BACKGROUND


No long-term follow-up data exist in any treatment for chronic radicular pain occurring with disc pathology and after failed back surgery. A previous randomized controlled trial (RCT) has proven efficacy in short-term follow-up as an evidence-based effective therapeutic option.
OBJECTIVES


Long term data is needed to determine the efficacy and cost- effectiveness of minimal invasive procedures. The present study reports 10 year follow-up results from the randomized trial.
STUDY DESIGN


A prospective, randomized, placebo-controlled, interventional clinical trial. A power calculation was based on a previous feasibility trial.
SETTING


University medical centers.
METHODS


After a 4 year enrollment phase, 381 patients with chronic radicular pain persisting beyond 4 months, who failed conservative treatments, were screened. Ninety patients were enrolled. Patients were randomly assigned to receive percutaneous epidural lysis of adhesions or placebo with concealed allocation in permuted blocks of 4 to 8 patients each, and stratified by treatment center. The primary outcomes were a mean change of the Oswestry Disability Index (ODI) scores and Visual Analog Scale (VAS), one and 10 years after intervention. For each rating scale an analysis of variance with the within-patient factor time (baseline, one year follow-up, 10 year follow-up) and the between-patient factor treatment (lysis, placebo) was used.
RESULTS


Homogeneity was shown at baseline between the groups. The ODI and VAS scores were significantly better one and 10 years in the lysis group vs the control group. The ODI in the lysis group improved from 55.3 ± 11.6 to 9.6 ± 9.3 after one year and to 11.7 ± 14.2 after 10 years. The placebo group also improved from 55.4 ± 11.5 to 30.7 ± 14.2 after one year and to 24.8 ± 12.0 after 10 years. The VAS improved from 6.7 ± 1.1 to 1.2 ± 1.1 after one year and to 1.5 ± 1.4 after 10 years in the lysis group and from 6.7 ± 1.1 to 2.8 ± 1.5 after one year and to 2.9 ± 1.3 after 10 years after placebo intervention. The statistical difference of the ODI and VAS between the treatment and control groups remain significant up to 10 years. No treatment-related severe adverse effects occurred within the 10 years, but minor transient neurological effects were seen directly after the intervention.
LIMITATIONS


The long-term effects of single treatment components cannot be specified as no imaging examination was performed at 10 year follow-up. A large variety of unanalyzed noninvasive treatments were done within the 10 years. Some patients did not clearly remember the intervention after 10 years. Uncontrolled effects such as higher inhomogeneity of biometric properties, concomitant therapies, pain tolerance level, or just social effects could occur, but were not analyzed in the trial.
CONCLUSION


This is the first 10 year follow-up report of a placebo-controlled RCT showing efficacy of the minimally invasive percutaneous adhesiolysis procedure for patients with chronic lumbosacral radicular pain. No alternative evidence-based treatment modality with 10 year follow-up is available to be recommended. This procedure should be considered as the first treatment option for patients with chronic lumbosacral radicular pain.",2021,The ODI and VAS scores were significantly better one and 10 years in the lysis group vs the control group.,"['381 patients with chronic radicular pain persisting beyond 4 months, who failed conservative treatments, were screened', 'University medical centers', 'Ninety patients were enrolled', 'Chronic Lumbar Radicular Pain', 'chronic radicular pain occurring with disc pathology and after failed back surgery', 'patients with chronic lumbosacral radicular pain']","['Percutaneous Epidural Neurolysis of Adhesions', 'placebo', 'placebo-controlled RCT', 'percutaneous epidural lysis of adhesions or placebo']","['ODI and VAS scores', 'transient neurological effects', 'ODI and VAS', 'severe adverse effects', 'mean change of the Oswestry Disability Index (ODI) scores and Visual Analog Scale (VAS), one and 10 years after intervention']","[{'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4552557', 'cui_str': 'Lumbar radicular pain'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0741419', 'cui_str': 'Back surgery'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0394927', 'cui_str': 'Epidural neurolysis'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",381.0,0.14519,The ODI and VAS scores were significantly better one and 10 years in the lysis group vs the control group.,"[{'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Gerdesmeyer', 'Affiliation': 'Dept. of Orthopedic Surgery and Traumatology, School of Medicine, Christian-Albrechts-University, Campus Kiel, Germany; Technical University of Munich, Dept. Orthopedics and Sportstraumatology, Technical University of Munich, Klinikum rechts der Isar, Munich, Germany.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Noe', 'Affiliation': 'Eugene McDermott Center for Pain Management at UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Prehn-Kristensen', 'Affiliation': 'Dept. of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Campus Kiel, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Harrasser', 'Affiliation': 'Eugene McDermott Center for Pain Management at UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Munjed Al', 'Initials': 'MA', 'LastName': 'Muderis', 'Affiliation': 'Department of Orthopedics and Traumatology, DIAKO Hospital Flensburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weuster', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, University Schleswig Holstein, Campus Kiel, Kiel, Germany; Macquarie University Hospital, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Klueter', 'Affiliation': 'Dept. of Orthopedic Surgery and Traumatology, School of Medicine, Christian-Albrechts-University, Campus Kiel, Germany.'}]",Pain physician,[]
996,34322921,"The effectiveness of mandala drawing in reducing psychological symptoms, anxiety and depression in hospitalised adolescents with cancer: A randomised controlled trial.","OBJECTIVE


This study aimed to evaluate the effectiveness of individual mandala drawing methods on psychological symptoms, anxiety and depression in hospitalised adolescents with cancer.
METHODS


A randomised controlled trial design with repeated measures was conducted. The study was carried out in a paediatric haematology and oncology clinic in Turkey. The study protocol is registered at ClinicalTrials.gov NCT04297982. The study sample consisted of 60 hospitalised adolescents aged between 12 and 17. Participants were randomly assigned to receive two 1- to 2-h mandala drawing sessions (intervention group, n = 30) or routine care only (control group, n = 30). Each adolescent was assessed using the Hospital Anxiety and Depression Scale and the Memorial Symptom Assessment Scale (Psychological subscale) questionnaires and was evaluated at baseline and after 5 days.
RESULTS


The anxiety and depression scores significantly decreased in the intervention group, compared with the control group, after 5 days of intervention, F(1, 57) = 28.9, p < 0.01, η 2   = 0.337. Similarly, the psychological symptoms scores significantly decreased in the intervention group, compared with the control group, F(1, 57) = 69.7, p < 0.001, η 2   = 0.550).
CONCLUSION


The individual mandala activity intervention was effective in reducing on psychological symptoms, anxiety and depressive symptoms in adolescents with cancer.",2021,"The anxiety and depression scores significantly decreased in the intervention group, compared with the control group, after 5 days of intervention, F(1, 57) = 28.9, p < 0.01, η 2   = 0.337.","['adolescents with cancer', 'paediatric haematology and oncology clinic in Turkey', 'hospitalised adolescents with cancer', '60 hospitalised adolescents aged between 12 and 17']","['individual mandala drawing methods', 'mandala drawing sessions (intervention group, n\u2009=\u200930) or routine care only (control group, n\u2009=\u200930', 'mandala drawing']","['anxiety and depression scores', 'Hospital Anxiety and Depression Scale and the Memorial Symptom Assessment Scale (Psychological subscale) questionnaires', 'psychological symptoms scores', 'psychological symptoms, anxiety and depressive symptoms', 'psychological symptoms, anxiety and depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1690538', 'cui_str': 'Pediatric hematology'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",60.0,0.0934434,"The anxiety and depression scores significantly decreased in the intervention group, compared with the control group, after 5 days of intervention, F(1, 57) = 28.9, p < 0.01, η 2   = 0.337.","[{'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Gürcan', 'Affiliation': 'Faculty of Nursing, Akdeniz University, Antalya, Turkey.'}, {'ForeName': 'Sevcan', 'Initials': 'S', 'LastName': 'Atay Turan', 'Affiliation': 'Faculty of Nursing, Akdeniz University, Antalya, Turkey.'}]",European journal of cancer care,['10.1111/ecc.13491']
997,34326179,Twelve-Month Outcomes of the First 1000 Days Program on Infant Weight Status.,"OBJECTIVES


To examine the effects of the First 1000 Days intervention on the prevalence of infant overweight and maternal postpartum weight retention and care.
METHODS


Using a quasi-experimental design, we evaluated the effects of the First 1000 Days program among 995 term, low-income infants and their mothers receiving care in 2 intervention community health centers and 650 dyads in 2 comparison health centers. The program includes staff training, growth tracking, health and behavioral screening, patient navigation, text messaging, educational materials, and health coaching. Comparison centers implemented usual care. Infant outcomes were assessed at 6 and 12 months, including weight-for-length  z  score and overweight (weight for length ≥97.7th percentile). We also examined maternal weight retention and receipt of care 6 weeks' post partum.
RESULTS


The mean birth weight was 3.34 kg (SD 0.45); 57% of infants were Hispanic; 66% were publicly insured. At 6 months, infants had lower weight-for-length  z  scores (β: -.27; 95% confidence interval [CI]: -.39 to -.15) and lower odds of overweight (adjusted odds ratio [OR]: 0.46; 95% CI: 0.28 to 0.76) than infants in comparison sites; differences persisted at 12 months ( z  score β: -.18; 95% CI: -.30 to -.07; adjusted OR for overweight: 0.60; 95% CI: 0.39 to 0.92). Mothers in the intervention sites had modestly lower, but nonsignificant, weight retention at 6 weeks' post partum (β: -.51 kg; 95% CI: -1.15 to .13) and had higher odds (adjusted OR: 1.50; 95% CI: 1.16 to 1.94) of completing their postpartum visit compared with mothers in the comparison sites.
CONCLUSIONS


An early-life systems-change intervention combined with coaching was associated with improved infant weight status and maternal postpartum care.",2021,An early-life systems-change intervention combined with coaching was associated with improved infant weight status and maternal postpartum care.,"['995 term, low-income infants and their mothers receiving care in 2 intervention community health centers and 650 dyads in 2 comparison health centers']","['staff training, growth tracking, health and behavioral screening, patient navigation, text messaging, educational materials, and health coaching']","['infant weight status and maternal postpartum care', 'mean birth weight', 'weight-for-length  z  score and overweight (weight for length ≥97.7th percentile', 'prevalence of infant overweight and maternal postpartum weight retention and care', 'lower weight-for-length  z  scores', 'Infant Weight Status', 'weight retention']","[{'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C4704955', 'cui_str': 'Infant Overweight'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.132677,An early-life systems-change intervention combined with coaching was associated with improved infant weight status and maternal postpartum care.,"[{'ForeName': 'Elsie M', 'Initials': 'EM', 'LastName': 'Taveras', 'Affiliation': 'The Kraft Center for Community Health elsie.taveras@mgh.harvard.edu.'}, {'ForeName': 'Meghan E', 'Initials': 'ME', 'LastName': 'Perkins', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children.'}, {'ForeName': 'Alexy Arauz', 'Initials': 'AA', 'LastName': 'Boudreau', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Blake-Lamb', 'Affiliation': 'The Kraft Center for Community Health.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Matathia', 'Affiliation': 'The Kraft Center for Community Health.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Kotelchuck', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children.'}, {'ForeName': 'Sarah N', 'Initials': 'SN', 'LastName': 'Price', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Roche', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children.'}, {'ForeName': 'Erika R', 'Initials': 'ER', 'LastName': 'Cheng', 'Affiliation': ""Division of Children's Health Services Research, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana.""}]",Pediatrics,['10.1542/peds.2020-046706']
998,34327766,Impact of UGT1A1 genotype on the efficacy and safety of irinotecan-based chemotherapy in metastatic colorectal cancer.,"The phase III AXEPT study showed the noninferiority of modified capecitabine plus irinotecan (mXELIRI) with or without bevacizumab relative to fluorouracil, leucovorin, and irinotecan (FOLFIRI) with or without bevacizumab as a second-line treatment for metastatic colorectal cancer. We evaluated the associations between the UGT1A1 genotype linked to adverse events-caused by irinotecan-and the efficacy and safety of mXELIRI and FOLFIRI. The UGT1A1 genotype was prospectively determined and patients were categorized into three groups according to WT (*1/*1), single heterozygous (SH; *28/*1 or *6/*1), and double heterozygous or homozygous (DHH; *28/*28, *6/*6, or *28/*6). Overall survival (OS), progression-free survival, response rate, and safety were assessed. The UGT1A1 genotype was available in all 650 randomized patients (WT, 309 [47.5%]; SH, 291 [44.8%]; DHH, 50 [7.7%]). The median OS was 15.9, 17.7, and 10.6 months in the WT, SH, and DHH groups, respectively, with an adjusted hazard ratio (HR) of 1.53 (95% confidence interval [CI], 1.12-2.09; P = .008) for DHH vs WT or SH. The median OS in the mXELIRI and FOLFIRI arms was 18.1 vs 14.3 months (HR 0.80; 95% CI, 0.62-1.03) in the WT group, 16.3 vs 18.3 months (HR 1.04; 95% CI, 0.79-1.36) in the SH group, and 13.0 vs 9.1 months (HR 0.71; 95% CI, 0.39-1.31) in the DHH group, respectively. Modified capecitabine plus irinotecan with or without bevacizumab could be a standard second-line chemotherapy in terms of efficacy and safety regardless of the UGT1A1 genotype.",2021,"The median OS in the mXELIRI and FOLFIRI arms was 18.1 vs. 14.3 months (HR 0.80; 95% CI 0.62-1.03) in the WT group, 16.3 vs. 18.3 months (HR 1.04; 95% CI 0.79-1.36) in the SH group, and 13.0 vs. 9.1 months (HR 0.71; 95% CI 0.39-1.31) in the DHH group, respectively.","['metastatic colorectal cancer (mCRC', 'Metastatic Colorectal Cancer']","['Irinotecan-based Chemotherapy', 'modified capecitabine plus irinotecan (mXELIRI) with or without bevacizumab relative to fluorouracil, leucovorin, and irinotecan (FOLFIRI) with or without bevacizumab', 'mXELIRI with or without bevacizumab']","['Overall survival (OS), progression-free survival, response rate, and safety', 'Efficacy and Safety', 'median OS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",650.0,0.135602,"The median OS in the mXELIRI and FOLFIRI arms was 18.1 vs. 14.3 months (HR 0.80; 95% CI 0.62-1.03) in the WT group, 16.3 vs. 18.3 months (HR 1.04; 95% CI 0.79-1.36) in the SH group, and 13.0 vs. 9.1 months (HR 0.71; 95% CI 0.39-1.31) in the DHH group, respectively.","[{'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Young Suk', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Chemotherapy, Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Department of Digestive Surgery, Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': 'Department of General Gastroenterological Surgery, Fujita Health University Hospital, Toyoake, Japan.'}, {'ForeName': 'Joong Bae', 'Initials': 'JB', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Yong Sang', 'Initials': 'YS', 'LastName': 'Hong', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sae Won', 'Initials': 'SW', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Sang-Hee', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hospital, Medical School, Gwangju, Korea.'}, {'ForeName': 'Dong-Sheng', 'Initials': 'DS', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Wei-Jia', 'Initials': 'WJ', 'LastName': 'Fang', 'Affiliation': 'Department of Medical Oncology, First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiang-Lin', 'Initials': 'XL', 'LastName': 'Yuan', 'Affiliation': 'Department of Gastrointestinal Oncology, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yasuhide', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Comprehensive Cancer Center, National Center for Global Health and Medicine, Shizuoka, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': 'Tokai Central Hospital, Kakamigahara, Japan.'}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}]",Cancer science,['10.1111/cas.15092']
999,34331551,Pharmacodynamic effects of indobufen compared with aspirin in patients with coronary atherosclerosis.,"PURPOSE


This study aimed to investigate the pharmacodynamic effects of indobufen and low-dose aspirin in patients with coronary atherosclerosis.
METHODS


In the first phase, 218 patients with coronary atherosclerosis were randomly assigned to receive aspirin 100 mg once daily (standard dose); 100 mg once every 2 days; 100 mg once every 3 days; 50 mg twice daily; 75 mg once daily; 50 mg once daily; or indobufen 100 mg twice daily for 1 month. In the second phase, 20 healthy subjects were treated with indobufen 100 mg twice daily for 1 week followed after a 2-week washout by aspirin 100 mg once daily for 1 week. The primary outcome was arachidonic acid-induced platelet aggregation (PL AA ), and the secondary outcomes included plasma thromboxane B 2  (TXB 2 ) and urinary 11-dehydro-TXB 2  (11-dh-TXB 2 ) levels at the end of each treatment.  RESULTS: In the first phase, compared with aspirin 100 mg once daily: all aspirin groups had similar suppression of PL AA  whereas indobufen group had significantly less suppressed PL AA . Aspirin given every second or third day, and indobufen produced less suppression of plasma TXB 2 . All treatment regimens produced similar inhibition of 11-dh-TXB 2 . In the second phase, compared with aspirin, indobufen produced less suppression of plasma TXB 2  at 8 h and 12 h after the last dose.
CONCLUSIONS


Aspirin 50 mg twice daily, 75 mg once daily, and aspirin 50 mg once daily produce antiplatelet effects that are similar to aspirin 100 mg once daily. Aspirin given less often than once daily and indobufen 100 mg twice daily do not suppress platelets as effectively as aspirin 100 mg once daily.",2021,Aspirin given less often than once daily and indobufen 100 mg twice daily do not suppress platelets as effectively as aspirin 100 mg once daily.,"['20 healthy subjects', '218 patients with coronary atherosclerosis', 'patients with coronary atherosclerosis']","['aspirin 100\xa0mg once daily for 1\xa0week', 'indobufen and low-dose aspirin', 'aspirin, indobufen', 'Aspirin', 'aspirin 100\xa0mg once daily (standard dose); 100\xa0mg once every 2\xa0days; 100\xa0mg once every 3\xa0days; 50\xa0mg twice daily; 75\xa0mg once daily; 50\xa0mg once daily; or indobufen', 'aspirin', 'indobufen']","['suppression of plasma TXB', 'suppression of PL AA', 'Pharmacodynamic effects', 'arachidonic acid-induced platelet aggregation (PL AA ), and the secondary outcomes included plasma thromboxane B 2  (TXB 2 ) and urinary 11-dehydro-TXB 2  (11-dh-TXB 2 ) levels', 'suppression of plasma TXB 2 ', 'pharmacodynamic effects']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0063479', 'cui_str': 'indobufen'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1275551', 'cui_str': 'Every three days'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1268820', 'cui_str': 'Arachidonic acid induced platelet aggregation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040061', 'cui_str': 'Thromboxane'}, {'cui': 'C0045550', 'cui_str': '2,5-dichloro-4-bromophenol'}, {'cui': 'C0529278', 'cui_str': '11-dehydrothromboxane B3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",218.0,0.132239,Aspirin given less often than once daily and indobufen 100 mg twice daily do not suppress platelets as effectively as aspirin 100 mg once daily.,"[{'ForeName': 'Mingwen', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Zekang', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lianlian', 'Initials': 'L', 'LastName': 'Mei', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Inam', 'Initials': 'I', 'LastName': 'Ullah', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Chuchu', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Guoyu', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Gu', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Samee', 'Initials': 'S', 'LastName': 'Abdus', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xiaoxuan', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Chunjian', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Departments of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China. lijay@njmu.edu.cn.'}]",European journal of clinical pharmacology,['10.1007/s00228-021-03177-y']
1000,34332453,"Deliberate practice in resuscitation training using a feedback device, and the effects of the physical characteristics of the rescuer on the acquisition and retention of cardiopulmonary resuscitation skills: Randomized clinical trial.","BACKGROUND


Cardiopulmonary resuscitation (CPR) skills decline rapidly and rescuers' physical characteristics could impact on their performance. Our aim was to analyse the effects of deliberate practice using a feedback device (FD) on the CPR performance of nursing students prior to, immediately after, and three months after training, considering their physical characteristics.
METHOD


Sixty nursing students participated in this randomized clinical trial (control group n = 28; training group n = 32). Their physical characteristics (weight, height, forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC)% index, handgrip strength, and CPR position strength) were measured before starting the trial. The training group followed a CPR training programme based on deliberate practice, providing feedback on their performance using an FD. All participants were evaluated during two-minute CPR compression/ventilation cycles.
RESULTS


The training group showed an improved ability to perform chest compressions (F (2, 115.2)  = 13.3; p < .001; ω 2 p  = 0.17) and ventilations (F (2, 115.3)  = 102.1; p < .001; ω 2 p  = 0.63), improving their overall quality of CPR (F (2, 115.2)  = 40.1; p < .001; ω 2 p  = 0.40). The physical characteristics of the participants did not affect CPR performance in any study phase.
CONCLUSIONS


A structured training programme based on deliberate practice using an FD had a positive effect on the acquisition of CPR skills by participants, while their physical characteristics had no impact on performance.",2021,"The training group showed an improved ability to perform chest compressions (F (2, 115.2)  = 13.3; p < .001; ω 2 p  = 0.17) and ventilations (F (2, 115.3)  = 102.1; p < .001; ω 2 p  = 0.63), improving their overall quality of CPR (F (2, 115.2)  = 40.1; p < .001;",['Sixty nursing students'],"['control group n\xa0=\xa028; training group n\xa0=\xa032', 'CPR training programme based on deliberate practice, providing feedback on their performance using an FD', 'deliberate practice using a feedback device (FD']","['FEV1)/forced vital capacity (FVC)% index, handgrip strength, and CPR position strength', 'physical characteristics (weight, height, forced expiratory volume in 1\xa0s ', 'ability to perform chest compressions', 'overall quality of CPR', 'CPR performance']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C1637833', 'cui_str': '% index'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",60.0,0.0151822,"The training group showed an improved ability to perform chest compressions (F (2, 115.2)  = 13.3; p < .001; ω 2 p  = 0.17) and ventilations (F (2, 115.3)  = 102.1; p < .001; ω 2 p  = 0.63), improving their overall quality of CPR (F (2, 115.2)  = 40.1; p < .001;","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Arrogante', 'Affiliation': 'Fundación San Juan de Dios, Centro de Ciencias de la Salud San Rafael, Universidad de Nebrija, Paseo de La Habana, 70, 28036 Madrid, Spain. Electronic address: oarrogan@nebrija.es.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Ríos-Díaz', 'Affiliation': 'Fundación San Juan de Dios, Centro de Ciencias de la Salud San Rafael, Universidad de Nebrija, Paseo de La Habana, 70, 28036 Madrid, Spain. Electronic address: jrios@nebrija.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Carrión-García', 'Affiliation': 'Fundación San Juan de Dios, Centro de Ciencias de la Salud San Rafael, Universidad de Nebrija, Paseo de La Habana, 70, 28036 Madrid, Spain. Electronic address: lcarrion@nebrija.es.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Samith', 'Affiliation': 'Fundación San Juan de Dios, Centro de Ciencias de la Salud San Rafael, Universidad de Nebrija, Paseo de La Habana, 70, 28036 Madrid, Spain. Electronic address: ssamith@nebrija.es.'}, {'ForeName': 'Gracia María', 'Initials': 'GM', 'LastName': 'González-Romero', 'Affiliation': 'Fundación San Juan de Dios, Centro de Ciencias de la Salud San Rafael, Universidad de Nebrija, Paseo de La Habana, 70, 28036 Madrid, Spain. Electronic address: gracia.mgr@gmail.com.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Caperos', 'Affiliation': 'Fundación San Juan de Dios, Centro de Ciencias de la Salud San Rafael, Universidad de Nebrija, Paseo de La Habana, 70, 28036 Madrid, Spain; UNINPSI, Dpto. de Psicología, Universidad Pontificia Comillas, Madrid, Spain. Electronic address: jcaperos@nebrija.es.'}]",International emergency nursing,['10.1016/j.ienj.2021.101037']
1001,34334656,Neoadjuvant Therapy for Resectable Pancreatic Cancer: A New Standard of Care. Pooled Data From 3 Randomized Controlled Trials.,"OBJECTIVE


The aim of this study was to pool data from randomized controlled trials (RCT) limited to resectable pancreatic ductal adenocarcinoma (PDAC) to determine whether a neoadjuvant therapy impacts on disease-free survival (DFS) and surgical outcome.
SUMMARY BACKGROUND DATA


Few underpowered studies have suggested benefits from neoadjuvant chemo (± radiation) for strictly resectable PDAC without offering conclusive recommendations.
METHODS


Three RCTs were identified comparing neoadjuvant chemo (± radio) therapy vs. upfront surgery followed by adjuvant therapy in all cases. Data were pooled targeting DFS as primary endpoint, whereas overall survival (OS), postoperative morbidity, and mortality were investigated as secondary endpoints. Survival endpoints DFS and OS were compared using Cox proportional hazards regression with study-specific baseline hazards.
RESULTS


A total of 130 patients were randomized (56 in the neoadjuvant and 74 in the control group). DFS was significantly longer in the neoadjuvant treatment group compared to surgery only [hazard ratio (HR) 0.6, 95% confidence interval (CI) 0.4-0.9] (P = 0.01). Furthermore, DFS for the subgroup of R0 resections was similarly longer in the neoadjuvant treated group (HR 0.6, 95% CI 0.35-0.9, P = 0.045). Although postoperative complications (Comprehensive Complication Index, CCI®) occurred less frequently (P = 0.008), patients after neoadjuvant therapy experienced a higher toxicity, but without negative impact on oncological or surgical outcome parameters.
CONCLUSION


Neoadjuvant therapy can be offered as an acceptable standard of care for patients with purely resectable PDAC. Future research with the advances of precision oncology should now focus on the definition of the optimal regimen.",2021,"DFS was significantly longer in the neoadjuvant treatment group compared to surgery only (hazard ratio (HR 0.6, 95% CI 0.4 to 0.9) (p= 0.01).","['patients with purely resectable PDAC', '130 patients were randomized (56 in the neoadjuvant and 74 in the control groups', 'Resectable Pancreatic Cancer', 'resectable pancreatic ductal adenocarcinoma (PDAC']","['neoadjuvant chemo (± radio) therapy vs. upfront surgery followed by adjuvant therapy', 'neoadjuvant chemo (± radiation', 'Neoadjuvant Therapy']","['toxicity', 'Survival endpoints DFS and OS', 'OS, postoperative morbidity and mortality', 'DFS', 'disease-free survival (DFS) and surgical outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0854778', 'cui_str': 'Pancreatic carcinoma resectable'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",130.0,0.123037,"DFS was significantly longer in the neoadjuvant treatment group compared to surgery only (hazard ratio (HR 0.6, 95% CI 0.4 to 0.9) (p= 0.01).","[{'ForeName': 'Dominique L', 'Initials': 'DL', 'LastName': 'Birrer', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Golcher', 'Affiliation': 'Department of Surgery, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Casadei', 'Affiliation': 'Division of Pancreatic Surgery, IRCCS, Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Haile', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Fritsch', 'Affiliation': 'Department of Oncology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Hussung', 'Affiliation': 'Department of Oncology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Brunner', 'Affiliation': 'Department of Radiation Oncology, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Department of Surgery, Hospital Ansbach, Ansbach, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'Department of Surgery, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Merkel', 'Affiliation': 'Department of Surgery, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Ricci', 'Affiliation': 'Division of Pancreatic Surgery, IRCCS, Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Ingaldi', 'Affiliation': 'Division of Pancreatic Surgery, IRCCS, Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Mariacristina', 'Initials': 'M', 'LastName': 'Di Marco', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Guido', 'Affiliation': 'Division of Pancreatic Surgery, IRCCS, Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Serra', 'Affiliation': 'Division of Pancreatic Surgery, IRCCS, Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Minni', 'Affiliation': 'Division of Pancreatic Surgery, IRCCS, Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Pestalozzi', 'Affiliation': 'Department of Oncology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Petrowsky', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'DeOliveira', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Wolf O', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'Department of General, Visceral- and Transplantation Surgery, University Hospital Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Christiane J', 'Initials': 'CJ', 'LastName': 'Bruns', 'Affiliation': 'Department of General and Transplantation Surgery, University Hospital Cologne, Köln, Germany.'}, {'ForeName': 'Christian E', 'Initials': 'CE', 'LastName': 'Oberkofler', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Milo', 'Initials': 'M', 'LastName': 'Puhan', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': 'Lesurtel', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Croix Rousse University Hospital, University Lyon I, Lyon, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Heinrich', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital of Mainz, Mainz, Germany.'}, {'ForeName': 'Pierre-Alain', 'Initials': 'PA', 'LastName': 'Clavien', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital Zurich, Zurich, Switzerland.'}]",Annals of surgery,['10.1097/SLA.0000000000005126']
1002,34334635,Hypothermic Oxygenated Machine Perfusion Reduces Early Allograft Injury and Improves Post-transplant Outcomes in Extended Criteria Donation Liver Transplantation From Donation After Brain Death: Results From a Multicenter Randomized Controlled Trial (HOPE ECD-DBD).,"OBJECTIVE


The aim of this study was to evaluate peak serum alanine aminotransferase (ALT) and postoperative clinical outcomes after hypothermic oxygenated machine perfusion (HOPE) versus static cold storage (SCS) in extended criteria donation (ECD) liver transplantation (LT) from donation after brain death (DBD).
BACKGROUND


HOPE might improve outcomes in LT, particularly in high-risk settings such as ECD organs after DBD, but this hypothesis has not yet been tested in a randomized controlled clinical trial (RCT).
METHODS


Between September 2017 and September 2020, 46 patients undergoing ECD-DBD LT from four centers were randomly assigned to HOPE (n = 23) or SCS (n = 23). Peak-ALT levels within 7 days following LT constituted the primary endpoint. Secondary endpoints included incidence of postoperative complications [Clavien-Dindo classification (CD), Comprehensive Complication Index (CCI)], length of intensive care- (ICU) and hospital-stay, and incidence of early allograft dysfunction (EAD).
RESULTS


Demographics were equally distributed between both groups [donor age: 72 (IQR: 59-78) years, recipient age: 62 (IQR: 55-65) years, labMELD: 15 (IQR: 9-25), 38 male and 8 female recipients]. HOPE resulted in a 47% decrease in serum peak ALT [418 (IQR: 221-828) vs 796 (IQR: 477-1195) IU/L, P = 0.030], a significant reduction in 90-day complications [44% vs 74% CD grade ≥3, P = 0.036; 32 (IQR: 12-56) vs 52 (IQR: 35-98) CCI, P = 0.021], and shorter ICU- and hospital-stays [5 (IQR: 4-8) vs 8 (IQR: 5-18) days, P = 0.045; 20 (IQR: 16-27) vs 36 (IQR: 23-62) days, P = 0.002] compared to SCS. A trend toward reduced EAD was observed for HOPE (17% vs 35%; P = 0.314).
CONCLUSION


This multicenter RCT demonstrates that HOPE, in comparison to SCS, significantly reduces early allograft injury and improves post-transplant outcomes in ECD-DBD liver transplantation.",2021,"A trend towards reduced EAD was observed for HOPE (17% vs. 35%; p=0.314).
","['extended criteria donation (ECD) liver transplantation (LT) from donation after brain death (DBD', 'Between 09/2017-09/2020 46 patients undergoing ECD-DBD LT from four centers', 'Demographics were equally distributed between both groups (donor age: 72 [IQR:59-78] years, recipient age: 62 [IQR:55-65] years, labMELD: 15 [IQR:9-25], 38 male and 8 female recipients']","['Hypothermic Oxygenated Machine Perfusion (HOPE', 'HOPE', 'hypothermic oxygenated machine perfusion (HOPE) versus static cold storage (SCS', 'SCS']","['shorter ICU- and hospital-stays', 'Peak-ALT levels', '90-day complications', 'serum peak ALT', 'incidence of postoperative complications (Clavien-Dindo classification (CD), Comprehensive Complication Index (CCI)), length of intensive care- (ICU) and hospital-stay, and incidence of early allograft dysfunction (EAD', 'peak serum alanine aminotransferase (ALT', 'EAD', 'Early Allograft Injury and Improves Post-Transplant Outcomes']","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1864233', 'cui_str': 'Myasthenic Syndrome, Congenital, Engel Type'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",46.0,0.160034,"A trend towards reduced EAD was observed for HOPE (17% vs. 35%; p=0.314).
","[{'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Czigany', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Pratschke', 'Affiliation': 'Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Froněk', 'Affiliation': 'Department of Transplantation Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Guba', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Wenzel', 'Initials': 'W', 'LastName': 'Schöning', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Dimitri Aristotle', 'Initials': 'DA', 'LastName': 'Raptis', 'Affiliation': 'Department of HPB Surgery and Liver Transplantation, Royal Free Hospital, London, UK.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Andrassy', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'Department of Hepatology, Maastricht University Medical Center (MUMC), Maastricht, The Netherlands.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Strnad', 'Affiliation': 'Department of Internal Medicine III, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Rene Hany', 'Initials': 'RH', 'LastName': 'Tolba', 'Affiliation': 'Institute for Laboratory Animal Science and Experimental Surgery, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': 'Institute for Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Miller', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Pavicevic', 'Affiliation': 'Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Uluk', 'Affiliation': 'Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Matej', 'Initials': 'M', 'LastName': 'Kocik', 'Affiliation': 'Department of Transplantation Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Lurje', 'Affiliation': 'Department of Hepatology and Gastroenterology, Campus Charité Mitte | Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Trautwein', 'Affiliation': 'Department of Internal Medicine III, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Arianeb', 'Initials': 'A', 'LastName': 'Mehrabi', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany.'}, {'ForeName': 'Irinel', 'Initials': 'I', 'LastName': 'Popescu', 'Affiliation': 'Department of General Surgery and Liver transplantation, Fundeni Clinical Institute, Bucharest, Romania.'}, {'ForeName': 'Florian Wolfgang Rudolf', 'Initials': 'FWR', 'LastName': 'Vondran', 'Affiliation': 'Department for General, Visceral and Transplant Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Ju', 'Affiliation': 'Department of Anesthesiology, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tacke', 'Affiliation': 'Department of Internal Medicine III, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Ulf Peter', 'Initials': 'UP', 'LastName': 'Neumann', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Lurje', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany.'}]",Annals of surgery,['10.1097/SLA.0000000000005110']
1003,34333414,"Body Positivity, but not for everyone: The role of model size in exposure effects on women's mood, body satisfaction, and food choice.","Body Positivity (or 'BoPo') social media content may be beneficial for women's mood and body image, but concerns have been raised that it may reduce motivation for healthy behaviours. This study examines differences in women's mood, body satisfaction, and hypothetical food choices after viewing BoPo posts (featuring average or larger women) or a neutral travel control. Women (N = 167, 81.8 % aged 18-29) were randomly assigned in an online experiment to one of three conditions (BoPo-average, BoPo-larger, or Travel/Control) and viewed three Instagram posts for two minutes, before reporting their mood and body satisfaction, and selecting a meal from a hypothetical menu. Women who viewed the BoPo posts featuring average-size women reported more positive mood than the control group; women who viewed posts featuring larger women did not. There were no effects of condition on negative mood or body satisfaction. Women did not make less healthy food choices than the control in either BoPo condition; women who viewed the BoPo images of larger women showed a stronger association between hunger and calories selected. These findings suggest that concerns over BoPo promoting unhealthy behaviours may be misplaced, but further research is needed regarding women's responses to different body sizes.",2021,Women did not make less healthy food choices than the control in either BoPo condition; women who viewed the BoPo images of larger women showed a stronger association between hunger and calories selected.,"['Women who viewed the BoPo posts featuring average-size women', 'Women (N = 167, 81.8 % aged 18-29', ""women's mood, body satisfaction, and hypothetical food choices after viewing BoPo posts (featuring average or larger women) or a neutral travel control""]",[],"['negative mood or body satisfaction', 'positive mood']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0168191,Women did not make less healthy food choices than the control in either BoPo condition; women who viewed the BoPo images of larger women showed a stronger association between hunger and calories selected.,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Simon', 'Affiliation': 'Bariatric Surgery, Chelsea & Westminster Hospital, 369 Fulham Rd, Chelsea, London, SW10 9NH, UK.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hurst', 'Affiliation': 'School of Psychology, University of Sussex, Falmer, Brighton, BN1 9QH, UK. Electronic address: m.hurst@sussex.ac.uk.'}]",Body image,['10.1016/j.bodyim.2021.07.001']
1004,34333391,The effect of milk and rapeseed protein on growth factors in 7-8 year-old healthy children - A randomized controlled trial.,"OBJECTIVE


Milk protein may stimulate linear growth through insulin-like growth factor-1 (IGF-1). However, the effect of plant proteins on growth factors is largely unknown. This study assesses the effect of combinations of milk and rapeseed protein versus milk protein alone on growth factors in children.
DESIGN


An exploratory 3-armed randomized, double-blind, controlled trial was conducted in 129 healthy 7-8 year-old Danish children. Children received 35 g milk and rapeseed protein (ratio 54:46 or 30:70) or 35 g milk protein per day for 4 weeks. The primary outcome was difference in IGF-1 changes between intervention groups after 4 weeks. Secondary outcomes included changes in IGF-1 after 1 week and changes in insulin-like growth factor binding protein-3 (IGFBP-3), IGF-1/IGFBP-3, insulin, height, weight and body composition after 1 and 4 weeks. Results were analysed by multiple linear mixed-effect models.
RESULTS


There were no differences in changes of plasma IGF-1, insulin-like growth factor binding protein-3 (IGFBP-3), IGF-1/IGFBP-3 ratio or insulin between groups after 1 or 4 weeks based on 89 complete cases (P > 0.10). IGF-1 increased by 13.7 (95% CI 9.7;17.7) ng/mL and 18.0 (14.0;22.0) ng/mL from baseline to week 1 and 4, respectively, a 16% increase during the intervention. Similarly, insulin increased by 31% (14; 50) and 33% (16; 53) from baseline to week 1 and 4. Fat-free mass index (FFMI) increments were higher with milk alone than rapeseed blends (P < 0.05), coinciding with a trend towards a lower height increment. Body mass index increased within all groups (P < 0.05), mainly due to an increase in FFMI (P < 0.01).
CONCLUSION


There were no differences in changes of growth factors between the combinations of milk and rapeseed protein and milk protein alone in healthy, well-nourished children with a habitual intake of milk. Within groups, growth factors increased considerably. Future studies are needed to investigate how intakes of plant and animal proteins affect childhood growth.",2021,"Body mass index increased within all groups (P < 0.05), mainly due to an increase in FFMI (P ","['children', '7-8\xa0year-old healthy children', '129 healthy 7-8\xa0year-old Danish children']","['milk and rapeseed protein', '35\xa0g milk and rapeseed protein (ratio 54:46 or 30:70) or 35\xa0g milk protein', 'milk and rapeseed protein versus milk protein alone']","['IGF-1', 'changes in IGF-1 after 1\xa0week and changes in insulin-like growth factor binding protein-3 (IGFBP-3), IGF-1/IGFBP-3, insulin, height, weight and body composition after 1 and 4\xa0weeks', 'plasma IGF-1, insulin-like growth factor binding protein-3 (IGFBP-3), IGF-1/IGFBP-3 ratio or insulin', 'Body mass index', 'growth factors', 'FFMI (P', 'Fat-free mass index (FFMI) increments', 'IGF-1 changes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0034670', 'cui_str': 'Brassica rapa'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0443625', 'cui_str': 'Binding protein 3'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",129.0,0.0846779,"Body mass index increased within all groups (P < 0.05), mainly due to an increase in FFMI (P ","[{'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Grenov', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: bgr@nexs.ku.dk.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Larnkjær', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: ala@nexs.ku.dk.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: ritz@nexs.ku.dk.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: kfm@nexs.ku.dk.'}, {'ForeName': 'Camilla T', 'Initials': 'CT', 'LastName': 'Damsgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: ctd@nexs.ku.dk.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mølgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: cm@nexs.ku.dk.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2021.101418']
1005,34332796,Comparison of enamel surface roughness and color alteration after bracket debonding and polishing with 2 systems: A split-mouth clinical trial.,"INTRODUCTION


This split-mouth randomized clinical trial aimed to compare the enamel surface roughness (SR) and color alteration after bracket debonding and polishing using 2 systems.
METHODS


After removal of excess adhesive using a 12-blade tungsten carbide bur on a low-speed handpiece, a randomized polishing procedure using Sof-Lex discs was applied on 1 side (n = 36) and Sof-Lex Spiral Wheels on the contralateral side (n = 36). Dental replicas were obtained with epoxy resin before bracket bonding and after tooth polishing. The SR was evaluated using a profilometer. The color was assessed using an Easyshade spectrophotometer before bracket bonding, immediately after tooth polishing, and 30 days after polishing. Two-way analysis of variance and t tests were applied for statistical analysis.
RESULTS


The SR of enamel showed similar results between the polishing systems (P = 0.309) and between moments (before bracket bonding and after tooth polishing) (P = 0.317). The color change was also similar between the polishing systems (P >0.05).
CONCLUSIONS


The Sof-Lex discs and Sof-Lex Spiral Wheel polishing systems used after removal of excess adhesive using a 12-blade tungsten carbide bur on a low-speed handpiece did not appear to significantly damage the enamel surface, and the color change was similar between them.",2021,The SR of enamel showed similar results between the polishing systems (P = 0.309) and between moments (before bracket bonding and after tooth polishing),[],[],['enamel surface roughness (SR) and color alteration'],[],[],"[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",36.0,0.0506164,The SR of enamel showed similar results between the polishing systems (P = 0.309) and between moments (before bracket bonding and after tooth polishing),"[{'ForeName': 'Célia Regina Maio', 'Initials': 'CRM', 'LastName': 'Pinzan-Vercelino', 'Affiliation': 'Division of Orthodontics, University Ceuma, São Luís, Maranhão, Brazil. Electronic address: cepinzan@hotmail.com.'}, {'ForeName': 'Ana Carla', 'Initials': 'AC', 'LastName': 'Souza Costa', 'Affiliation': 'Division of Orthodontics, University Ceuma, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Júlio Araújo', 'Initials': 'JA', 'LastName': 'Gurgel', 'Affiliation': 'Department of Orthodontics, State University of São Paulo, Marília, São Paulo, Brazil.'}, {'ForeName': 'Karina Maria', 'Initials': 'KM', 'LastName': 'Salvatore Freitas', 'Affiliation': 'Department of Orthodontics, Uninga University Center, Maringá, Brazil.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.06.039']
1006,34332788,"Comparison of the Efficacy and Safety of Atorvastatin 40 mg/ω-3 Fatty Acids 4 g Fixed-dose Combination and Atorvastatin 40 mg Monotherapy in Hypertriglyceridemic Patients who Poorly Respond to Atorvastatin 40 mg Monotherapy: An 8-week, Multicenter, Randomized, Double-blind Phase III Study.","PURPOSE


Residual cardiovascular risk in patients with hypertriglyceridemia, despite optimal low-density lipoprotein cholesterol levels being achieved with intensive statin treatment, is a global health issue. The purpose of this study was to investigate the efficacy and tolerability of treatment with a combination of high-dose atorvastatin/Ω-3 fatty acid compared to atorvastatin + placebo in patients with hypertriglyceridemia who did not respond to statin treatment.
METHODS


In this multicenter, randomized, double-blind, placebo-controlled study, patients who had residual hypertriglyceridemia after a 4-week run-in period of atorvastatin treatment were randomly assigned to receive UI-018 (fixed-dose combination atorvastatin/Ω-3 fatty acid 40 mg/4 g) or atorvastatin 40 mg + placebo (control). The primary efficacy end points were the percentage change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) level at the end of treatment and the adverse events recorded during treatment. A secondary end point was the percentage change from baseline in triglyceride level.
FINDINGS


After 8 weeks of treatment, the percentage changes from baseline in non-HDL-C (-4.4% vs +0.6%; p = 0.02) and triglycerides (-18.5% vs +0.9%; p < 0.01) were significantly greater in the UI-018 group (n = 101) than in the control group (n = 99). These changes were present in subgroups of advanced age (≥65 years), status (body mass index ≥25 kg/m 2 ), or without diabetes. The prevalences of adverse events did not differ between the 2 treatment groups.
IMPLICATIONS


In patients with residual hypertriglyceridemia despite receiving statin treatment, a combination of high-dose atorvastatin/Ω-3 fatty acid was associated with a greater reduction of triglyceride and non-HDL-C compared with atorvastatin + placebo, without significant adverse events.",2021,"The prevalences of adverse events did not differ between the 2 treatment groups.
","['patients with hypertriglyceridemia who did not respond to statin treatment', 'subgroups of advanced age (≥65 years), status (body mass index ≥25 kg/m 2 ), or without diabetes', 'Hypertriglyceridemic Patients', 'patients with hypertriglyceridemia, despite optimal low-density lipoprotein cholesterol levels being achieved with', 'patients who had residual hypertriglyceridemia after a 4-week run-in period of atorvastatin treatment', 'patients with residual hypertriglyceridemia despite receiving statin treatment, a combination of high-dose']","['UI-018 (fixed-dose combination atorvastatin/Ω-3 fatty acid 40 mg/4 g) or atorvastatin 40 mg\xa0+\xa0placebo (control', 'atorvastatin/Ω-3 fatty acid', 'intensive statin treatment', 'Atorvastatin 40 mg/ω-3 fatty acids 4 g Fixed-Dose Combination and Atorvastatin 40 mg Monotherapy', 'atorvastatin\xa0+\xa0placebo', 'placebo', 'Atorvastatin 40 mg Monotherapy']","['adverse events', 'percentage change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) level', 'triglycerides', 'efficacy and tolerability', 'prevalences of adverse events', 'triglyceride level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",,0.324115,"The prevalences of adverse events did not differ between the 2 treatment groups.
","[{'ForeName': 'Jong Shin', 'Initials': 'JS', 'LastName': 'Woo', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Hoon', 'Initials': 'DH', 'LastName': 'Cha', 'Affiliation': 'Department of Cardiology, CHA Bundang Medical Center, CHA University, Sungnam, Republic of Korea.'}, {'ForeName': 'Kee Sik', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Moo Hyun', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Dong-A University Medical Center, Busan, Republic of Korea.'}, {'ForeName': 'Jun-Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.'}, {'ForeName': 'Myung Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Jin-Ok', 'Initials': 'JO', 'LastName': 'Jeong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chungnam National University College of Medicine, Deajeon, Republic of Korea.'}, {'ForeName': 'Jun-Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kang-Dong Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea.'}, {'ForeName': 'Doo Soo', 'Initials': 'DS', 'LastName': 'Jeon', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Incheon St. Mary's Hospital, Incheon, Republic of Korea.""}, {'ForeName': 'Eun Joo', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, Yeouido St. Mary's Hospital, Catholic University, Seoul, Republic of Korea.""}, {'ForeName': 'Soon Kil', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Republic of Korea.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kwan', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Chang Gyu', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hae Young', 'Initials': 'HY', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Taek Jong', 'Initials': 'TJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Jinho', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Hanyang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ho Joong', 'Initials': 'HJ', 'LastName': 'Youn', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Dong Woon', 'Initials': 'DW', 'LastName': 'Jeon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, NHIS Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Wook Jin', 'Initials': 'WJ', 'LastName': 'Chung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Gil Hospital, Gachon University, Incheon, Republic of Korea.'}, {'ForeName': 'Ju Cheol', 'Initials': 'JC', 'LastName': 'Jeong', 'Affiliation': 'Department of Pharmacology, School of Medicine, Chung-Ang University, Seoul, Republic of Korea.'}, {'ForeName': 'Chong Jin', 'Initials': 'CJ', 'LastName': 'Kim', 'Affiliation': 'The Division of Cardiology, Department of Internal Medicine, Kyunghee University Hospital at Gangdong, Seoul, Republic of Korea. Electronic address: chongjinkim@naver.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2021.07.001']
1007,34375393,Cognitive response to testosterone replacement added to intensive lifestyle intervention in older men with obesity and hypogonadism: prespecified secondary analyses of a randomized clinical trial.,"BACKGROUND


Both obesity and hypogonadism are common in older men which could additively exacerbate age-related declines in cognitive function. However, little is known about the effects of lifestyle intervention plus testosterone replacement therapy in this population.
OBJECTIVES


In this secondary analysis of the LITROS (Lifestyle Intervention and Testosterone Replacement in Obese Seniors) trial, we examined whether testosterone replacement therapy would improve cognitive function when added to intensive lifestyle intervention in older men with obesity and hypogonadism.
METHODS


Eighty-three older, obese hypogonadal men with frailty were randomly assigned to lifestyle therapy (weight management and exercise training) plus testosterone (LT + Test) or lifestyle therapy plus placebo (LT + Pbo) for 6 mo. For this report, the primary outcome was change in the global cognition composite z score. Secondary outcomes included changes in z score subcomponents: attention/information processing, memory, executive function, and language. Changes between groups were analyzed using mixed-model repeated-measures ANCOVAs following the intention-to-treat principle.
RESULTS


Global cognition z score increased more in the LT + Test than in the LT + Pbo group (mean change: 0.49 compared with 0.21; between-group difference: -0.28; 95% CI: -0.45, -0.11; Cohen's d = 0.74). Moreover, attention/information z score and memory z score increased more in the LT + Test than in the LT + Pbo group (mean change: 0.55 compared with 0.23; between-group difference: -0.32; 95% CI: -0.55, -0.09; Cohen's d = 0.49 and mean change: 0.90 compared with 0.37; between-group difference: -0.53; 95% CI: -0.93, -0.13; Cohen's d = 1.43, respectively). Multiple regression analyses showed that changes in peak oxygen consumption, strength, total testosterone, and luteinizing hormone were independent predictors of the improvement in global cognition (R2 = 0.38; P < 0.001).
CONCLUSIONS


These findings suggest that in the high-risk population of older men with obesity and hypogonadism, testosterone replacement may improve cognitive function with lifestyle behaviors controlled via lifestyle intervention therapy.This trial was registered at clinicaltrials.gov as NCT02367105.",2021,"Multiple regression analyses showed that changes in peak oxygen consumption, strength, total testosterone, and luteinizing hormone were independent predictors of the improvement in global cognition (R2 = 0.38; P < 0.001).
","['Obese Seniors', 'Eighty-three older, obese hypogonadal men with frailty', 'older men with obesity and hypogonadism', 'older men']","['testosterone replacement added to intensive lifestyle intervention', 'lifestyle therapy (weight management and exercise training) plus testosterone (LT\xa0+\xa0Test) or lifestyle therapy plus placebo (LT\xa0+\xa0Pbo', 'intensive lifestyle intervention', 'Lifestyle Intervention and Testosterone Replacement', 'testosterone replacement therapy', 'testosterone replacement']","['cognitive function', 'global cognition', 'attention/information z score and memory z score', 'Global cognition z score', 'global cognition composite z score', 'changes in z score subcomponents: attention/information processing, memory, executive function, and language', 'peak oxygen consumption, strength, total testosterone, and luteinizing hormone', 'Cognitive response']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",,0.192091,"Multiple regression analyses showed that changes in peak oxygen consumption, strength, total testosterone, and luteinizing hormone were independent predictors of the improvement in global cognition (R2 = 0.38; P < 0.001).
","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Gregori', 'Affiliation': 'Center for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Celli', 'Affiliation': 'Center for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Barnouin', 'Affiliation': 'Center for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Paudyal', 'Affiliation': 'Center for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Armamento-Villareal', 'Affiliation': 'Center for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Napoli', 'Affiliation': 'Division of Endocrinology and Metabolism, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': 'Department of Mathematics and Statistics, University of New Mexico School of Medicine, Albuquerque, NM, USA.'}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Villareal', 'Affiliation': 'Center for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab253']
1008,34375388,"Temporal changes in soluble angiotensin-converting enzyme 2 associated with metabolic health, body composition, and proteome dynamics during a weight loss diet intervention: a randomized trial with implications for the COVID-19 pandemic.","BACKGROUND


Angiotensin-converting enzyme 2 (ACE2) serves protective functions in metabolic, cardiovascular, renal, and pulmonary diseases and is linked to COVID-19 pathology. The correlates of temporal changes in soluble ACE2 (sACE2) remain understudied.
OBJECTIVES


We explored the associations of sACE2 with metabolic health and proteome dynamics during a weight loss diet intervention.
METHODS


We analyzed 457 healthy individuals (mean ± SD age: 39.8 ± 6.6 y) with BMI 28-40 kg/m2 in the DIETFITS (Diet Intervention Examining the Factors Interacting with Treatment Success) study. Biochemical markers of metabolic health and 236 proteins were measured by Olink CVDII, CVDIII, and Inflammation I arrays at baseline and at 6 mo during the dietary intervention. We determined clinical and routine biochemical correlates of the diet-induced change in sACE2 (ΔsACE2) using stepwise linear regression. We combined feature selection models and multivariable-adjusted linear regression to identify protein dynamics associated with ΔsACE2.
RESULTS


sACE2 decreased on average at 6 mo during the diet intervention. Stronger decline in sACE2 during the diet intervention was independently associated with female sex, lower HOMA-IR and LDL cholesterol at baseline, and a stronger decline in HOMA-IR, triglycerides, HDL cholesterol, and fat mass. Participants with decreasing HOMA-IR (OR: 1.97; 95% CI: 1.28, 3.03) and triglycerides (OR: 2.71; 95% CI: 1.72, 4.26) had significantly higher odds for a decrease in sACE2 during the diet intervention than those without (P ≤ 0.0073). Feature selection models linked ΔsACE2 to changes in α-1-microglobulin/bikunin precursor, E-selectin, hydroxyacid oxidase 1, kidney injury molecule 1, tyrosine-protein kinase Mer, placental growth factor, thrombomodulin, and TNF receptor superfamily member 10B. ΔsACE2 remained associated with these protein changes in multivariable-adjusted linear regression.
CONCLUSIONS


Decrease in sACE2 during a weight loss diet intervention was associated with improvements in metabolic health, fat mass, and markers of angiotensin peptide metabolism, hepatic and vascular injury, renal function, chronic inflammation, and oxidative stress. Our findings may improve the risk stratification, prevention, and management of cardiometabolic complications.This trial was registered at clinicaltrials.gov as NCT01826591.",2021,"Participants with decreasing HOMA-IR (OR: 1.97; 95% CI: 1.28, 3.03) and triglycerides (OR: 2.71; 95% CI: 1.72, 4.26) had significantly higher odds for a decrease in sACE2 during the diet intervention than those without (P ≤ 0.0073).",['457 healthy individuals (mean\xa0±\xa0SD age: 39.8\xa0±\xa06.6 y) with BMI 28-40\xa0kg/m2 in the DIETFITS'],['Angiotensin-converting enzyme 2 (ACE2'],"['HOMA-IR, triglycerides, HDL cholesterol, and fat mass', 'sACE2', 'female sex, lower HOMA-IR and LDL cholesterol', 'metabolic health, fat mass, and markers of angiotensin peptide metabolism, hepatic and vascular injury, renal function, chronic inflammation, and oxidative stress', 'Mer, placental growth factor, thrombomodulin, and TNF receptor superfamily member 10B. ΔsACE2', 'HOMA-IR', 'Olink CVDII, CVDIII, and Inflammation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0178324', 'cui_str': 'Injury of blood vessel'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0138514', 'cui_str': 'Placenta Growth Factor'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C1527752', 'cui_str': 'TNFRSF10B protein, human'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",457.0,0.0445956,"Participants with decreasing HOMA-IR (OR: 1.97; 95% CI: 1.28, 3.03) and triglycerides (OR: 2.71; 95% CI: 1.72, 4.26) had significantly higher odds for a decrease in sACE2 during the diet intervention than those without (P ≤ 0.0073).","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Cauwenberghs', 'Affiliation': 'Stanford Cardiovascular Institute, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Prunicki', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'František', 'Initials': 'F', 'LastName': 'Sabovčik', 'Affiliation': 'Research Unit Hypertension and Cardiovascular Epidemiology, KU Leuven Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Perelman', 'Affiliation': 'Department of Genetics, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Contrepois', 'Affiliation': 'Stanford Cardiovascular Institute, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Biochemistry, The Center for RNA Science and Therapeutics, School of Medicine, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Snyder', 'Affiliation': 'Stanford Cardiovascular Institute, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Kuznetsova', 'Affiliation': 'Research Unit Hypertension and Cardiovascular Epidemiology, KU Leuven Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': 'Stanford Cardiovascular Institute, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Diabetes Research Center, Stanford University, Stanford, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab243']
1009,34378861,"Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar MYL-1601D with US and European insulin aspart in healthy volunteers: A randomized, double-blind, crossover, euglycaemic glucose clamp study.","AIM


To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence (BE) of MYL-1601D biosimilar with originator, NovoLog (Ref-InsAsp-US), and NovoRapid (Ref-InsAsp-EU).
MATERIALS AND METHODS


This was a double-blind, randomized, crossover study that enrolled 71 healthy subjects to receive a single subcutaneous dose (0.2 U/kg) of each formulation under automated euglycaemic clamp conditions (ClampArt, level 81 mg/dL, duration 12 hours postdose). Primary PK endpoints were area under the plasma insulin aspart concentration-time curve from 0 to 12 hours (AUC 0-12h  ) and maximum plasma insulin aspart concentration (C max  ). Primary PD endpoints were area under the glucose infusion rate (GIR) time curve from 0 to 12 hours (AUC GIR0-12h  ) and maximum GIR (GIR max  ). Insulin aspart in plasma was quantified using immunoaffinity purification followed by ultraperformance liquid chromatography and tandem mass spectrometric detection. The pairwise comparisons of geometric least square mean (LS-mean) ratio for a 90% confidence interval (CI) of primary PK, and 90% CIs (MYL-1601D vs. Ref-InsAsp-US) and 95% CIs (MYL-1601D vs. Ref-InsAsp-EU) of primary PD variables, were to be within 80% to 125% to show BE.
RESULTS


MYL-1601D showed PK BE to both Ref-InsAsp-US (AUC 0-12h  geometric LS-mean ratio 102.17, 90% CI [100.26; 104.11]; C max  106.13 [100.71; 111.85]) and Ref-InsAsp-EU (AUC 0-12h  101.84 [100.04; 103.67]; C max  105.74 [101.09; 110.60]). Likewise, MYL-1601D showed PD BE to Ref-InsAsp-US (AUC GIR_0-last  99.93; 90% CI [95.74; 104.30]; GIR _max  100.12 [94.46; 106.12]) and Ref-InsAsp-EU (AUC GIR_0-last  96.42; 95% CI [91.17; 101.98]; GIR _max  95.10 [89.37; 101.19]). All three insulin aspart products were well tolerated.
CONCLUSION


MYL-1601D showed BE to Ref-InsAsp-US and Ref-InsAsp-EU with a comparable safety profile.",2021,"MYL-1601D showed PK bioequivalence to both Ref-InsAsp-US (AUC 0-12h  geometric LS-mean ratio 102.17, 90% CI [100.26; 104.11]; C max  106.13","['enrolled 71 healthy subjects', 'Healthy Volunteers']","['Insulin aspart', 'Biosimilar MYL-1601D with US and European Insulin Aspart', 'MYL-1601D biosimilar with originator, NovoLog® (Ref-InsAsp-US) and NovoRapid® (Ref-InsAsp-EU', 'single subcutaneous dose (0.2\u2009U/kg) of each formulation under automated euglycemic clamp conditions (ClampArt®, level 81\u2009mg/dL']","['area under the glucose infusion rate (GIR) time curve from 0 to 12\u2009hours (AUC GIR0-12h  ) and maximum GIR (GIR max  ', 'PK bioequivalence', 'pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence', 'tolerated', 'area under the plasma insulin aspart concentration-time curve from 0 to 12\u2009hours (AUC 0-12h  ) and maximum plasma insulin aspart concentration (C max  ']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1300561', 'cui_str': 'U/kg'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456695', 'cui_str': '/12h'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",71.0,0.427086,"MYL-1601D showed PK bioequivalence to both Ref-InsAsp-US (AUC 0-12h  geometric LS-mean ratio 102.17, 90% CI [100.26; 104.11]; C max  106.13","[{'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hövelmann', 'Affiliation': 'Profil Institute, Neuss, Germany.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Raiter', 'Affiliation': 'Viatris Inc., Amstelveen, The Netherlands.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Chullikana', 'Affiliation': 'Biocon Biologics Limited, Bengaluru, India.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Viatris Inc., Morgantown, West Virginia, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Donnelly', 'Affiliation': 'Viatris Inc., Morgantown, West Virginia, USA.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Lawrence', 'Affiliation': 'Viatris Inc., Morgantown, West Virginia, USA.'}, {'ForeName': 'Nilanjan', 'Initials': 'N', 'LastName': 'Sengupta', 'Affiliation': 'Biocon Biologics Limited, Bengaluru, India.'}, {'ForeName': 'Gopu', 'Initials': 'G', 'LastName': 'Cl', 'Affiliation': 'Biocon Biologics Limited, Bengaluru, India.'}, {'ForeName': 'Gopinath', 'Initials': 'G', 'LastName': 'Ranganna', 'Affiliation': 'Viatris Inc., Bengaluru, India.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Barve', 'Affiliation': 'Viatris Inc., Canonsburg, Pennsylvania, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14519']
1010,34327630,Clinical and radiological outcomes of endoscopic foraminoplasty and decompression assisted with preoperative planning software for lumbar foraminal stenosis.,"PURPOSE


To assess the clinical and radiological outcomes of using endoscopic foraminoplasty and decompression assisted with a preoperative planning software in the treatment of lumbar foraminal stenosis.
METHODS


This retrospective study included 43 patients with lumbar foraminal stenosis (Jan 2018 and June 2019). These patients were divided into two groups. Patients in the conventional group (group A) underwent endoscopic lumbar foraminoplasty and decompression. Patients in the experimental group (group B) underwent the same surgery assisted with a preoperative software. The total operation time, puncture-channel establishment time, and the number of intraoperative fluoroscopic images taken were recorded. The Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) were administered preoperatively and postoperatively (at 1-month, 3-month, and 12-month follow-up). The modified MacNab criteria were used to assess the global outcome at 12-month follow-up.
RESULTS


Patients in group B had shorter operation time, puncture-channel establishment time, and less number of intraoperative fluoroscopic images taken, as compared with group A. The VAS and ODI scores were significantly lower than pre-operation for both groups at all follow-ups. No significant difference was observed between these two groups. Based on the modified MacNab criteria, the excellent-to-good rate was 86.4% in group A and 90.5% in group B, respectively. After the operation, no patients had residual osteophytes in group B, while two patients still had residual osteophytes and foraminal stenosis in group A.
CONCLUSION


For endoscopic surgery treating lumbar foraminal stenosis, using preoperative planning software could reduce the puncture-channel establishment time, operation time, and the number of intraoperative fluoroscopic images taken without affecting the clinical outcomes.",2021,"RESULTS


Patients in group B had shorter operation time, puncture-channel establishment time, and less number of intraoperative fluoroscopic images taken, as compared with group A. The VAS and ODI scores were significantly lower than pre-operation for both groups at all follow-ups.","['lumbar foraminal stenosis', '43 patients with lumbar foraminal stenosis (Jan 2018 and June 2019']","['endoscopic lumbar foraminoplasty and decompression', 'endoscopic foraminoplasty and decompression assisted with preoperative planning software', 'endoscopic foraminoplasty and decompression assisted with a preoperative planning software']","['shorter operation time, puncture-channel establishment time, and less number of intraoperative fluoroscopic images', 'Visual Analog Scale (VAS) and Oswestry Disability Index (ODI', 'VAS and ODI scores', 'puncture-channel establishment time, operation time', 'total operation time, puncture-channel establishment time, and the number of intraoperative fluoroscopic images taken']","[{'cui': 'C3889054', 'cui_str': 'Lumbar foraminal stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",43.0,0.0347243,"RESULTS


Patients in group B had shorter operation time, puncture-channel establishment time, and less number of intraoperative fluoroscopic images taken, as compared with group A. The VAS and ODI scores were significantly lower than pre-operation for both groups at all follow-ups.","[{'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Shi', 'Affiliation': ""Department of Spine Surgery, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ""Department of Spine Surgery, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Guoke', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': ""Department of Spine Surgery, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': ""Department of Spine Surgery, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Hailong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ""Department of Spine Surgery, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': ""Department of Spine Surgery, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ""Department of Spine Surgery, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China. xuguohuamail@smmu.edu.cn.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': ""Department of Spine Surgery, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China. guxin2004ty@163.com.""}]",International journal of computer assisted radiology and surgery,['10.1007/s11548-021-02453-7']
1011,34327070,Mobile Augmented Screening to Increase HIV Testing Among Emergency Department Patients as Young as 13 Years.,"Because adolescents and emerging adults are frequently not offered HIV testing, and often decline tests when offered, we developed and tested a tablet-based intervention to increase HIV test rates among emergency department (ED) patients aged 13-24 years. Pediatric and adult ED patients in a high volume New York City hospital (N = 295) were randomized to receive a face-to-face HIV test offer, or to complete a tablet-based intervention that contained an HIV test offer delivered via computer. Test rates in both conditions were then compared to historic test rates in the same ED during the previous six months. Among participants aged 19 years and younger who were offered HIV testing and declined before enrollment in the study, participants in the tablet-based condition were 1.7 times more likely to test for HIV compared to participants in the face-to-face condition. Participants aged 19 years and younger were three times as likely to test for HIV compared to patients the same age who were treated in the previous six months (26.39%, n = 71 study participants vs. 10.29%, n = 189 prior patients, OR = 3.13, [Formula: see text] 2  = 54.76, p < 0.001). Protocols designed to offer HIV testing to all eligible patients can significantly increase adolescent test rates compared to standard practice. Because tablets are equally effective compared to face-to-face offers, and in some cases more so, EDs may consider tablet-based interventions that require fewer staff resources and may integrate more easily into high-volume workflows.",2021,"Participants aged 19 years and younger were three times as likely to test for HIV compared to patients the same age who were treated in the previous six months (26.39%, n = 71 study participants vs. 10.29%, n = 189 prior patients, OR = 3.13, [Formula: see text]","['Pediatric and adult ED patients in a high volume New York City hospital (N = 295', 'emergency department (ED) patients aged 13-24 years', 'Emergency Department Patients as Young as 13 Years', 'Participants aged 19 years and younger were three times as likely to test for HIV compared to patients the same age who were treated in the previous six months (26.39%, n = 71 study participants vs. 10.29%, n = 189 prior patients, OR = 3.13, [Formula: see text', 'participants aged 19 years and younger who were offered HIV testing and declined before enrollment in the study, participants in the tablet-based condition were 1.7 times more likely to test for HIV compared to participants in the face-to-face condition']",[],['adolescent test rates'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C5191364', 'cui_str': '3.13'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",295.0,0.0816607,"Participants aged 19 years and younger were three times as likely to test for HIV compared to patients the same age who were treated in the previous six months (26.39%, n = 71 study participants vs. 10.29%, n = 189 prior patients, OR = 3.13, [Formula: see text]","[{'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Aronson', 'Affiliation': 'Research, Digital Health Empowerment, Brooklyn, USA.'}, {'ForeName': 'Jingru', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Measurement and Evaluation, Teachers College, Columbia University, New York, USA.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Rajan', 'Affiliation': 'Department of Health and Behavior Studies, Teachers College, Columbia University, New York, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bugaighis', 'Affiliation': 'Emergency Medicine, Columbia University Irving Medical Center, New York, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Marsch', 'Affiliation': 'Center for Technology and Behavioral Health, Dartmouth College, Lebanon, USA.'}, {'ForeName': 'Mobolaji', 'Initials': 'M', 'LastName': 'Ibitoye', 'Affiliation': 'Institute for Population Research, The Ohio State University, Columbus, USA.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Chernick', 'Affiliation': 'Emergency Medicine, Columbia University Irving Medical Center, New York, USA.'}, {'ForeName': 'Don C', 'Initials': 'DC', 'LastName': 'Des Jarlais', 'Affiliation': 'Epidemiology, New York University School of Global Public Health, New York, USA.'}]",Cureus,['10.7759/cureus.15829']
1012,34330204,Effects of a Brief Mindful Hypnosis Intervention on Stress Reactivity: A Randomized Active Control Study.,"A novel, audio-based brief mindful hypnosis (BMH) intervention for reducing stress-reactivity during the Trier Social Stress Test (TSST) was investigated. Fifty-five college-aged participants with elevated stress were randomized to BMH or a cognitive training (CT) active-control condition. Participants received a BMH or CT session and downloaded the audio-recorded intervention for daily home practice. Approximately 1 week later, participants received their second BMH or CT session and then completed the TSST. Results indicated BMH produced significant and medium effects in reducing stress reactivity and weekly stress and increasing mindfulness, with large increases in immediate relaxation compared to the CT active control. BMH demonstrated excellent adherence and was rated highly regarding satisfaction, ease of practice, perceived benefit, and likelihood of future use. This study provides the first empirical support that BMH is superior to an active-control intervention for reducing stress reactivity while significantly increasing mindfulness and relaxation.",2021,"Results indicated BMH produced significant and medium effects in reducing stress reactivity and weekly stress and increasing mindfulness, with large increases in immediate relaxation compared to the CT active control.",['Fifty-five college-aged participants with elevated stress'],"['audio-based brief mindful hypnosis (BMH) intervention', 'second BMH or CT session and then completed the TSST', 'Brief Mindful Hypnosis Intervention', 'BMH or a cognitive training (CT) active-control condition', 'BMH or CT session and downloaded the audio-recorded intervention for daily home practice']","['stress reactivity', 'immediate relaxation', 'stress-reactivity', 'stress reactivity and weekly stress and increasing mindfulness', 'Stress Reactivity']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",55.0,0.0142376,"Results indicated BMH produced significant and medium effects in reducing stress reactivity and weekly stress and increasing mindfulness, with large increases in immediate relaxation compared to the CT active control.","[{'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Slonena', 'Affiliation': 'Department of Psychology and Neuroscience, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Elkins', 'Affiliation': 'Department of Psychology and Neuroscience, Baylor University, Waco, Texas, USA.'}]",The International journal of clinical and experimental hypnosis,['10.1080/00207144.2021.1952845']
1013,34331964,The response to prolonged fasting in hypothalamic serotonin transporter availability is blunted in obesity.,"BACKGROUND AND AIMS


Serotonergic and dopaminergic systems in the brain are essential for homeostatic and reward-associated regulation of food intake and systemic energy metabolism. It is largely unknown how fasting influences these systems or if such effects are altered in humans with obesity. We therefore aimed to evaluate the effects of fasting on hypothalamic/thalamic serotonin transporter (SERT) and striatal dopamine transporter (DAT) availability in lean subjects and subjects with obesity.
METHODS


In this randomized controlled cross-over trial, we assessed the effects of 12 vs 24 h of fasting on SERT and DAT availability in the hypothalamus/thalamus and striatum, respectively, using SPECT imaging in 10 lean men and 10 men with obesity.
RESULTS


As compared with the 12-h fast, a 24-h fast increased hypothalamic SERT availability in lean men, but not in men with obesity. We observed high inter-individual variation in the effects of fasting on thalamic SERT and striatal DAT, with no differences between lean men and those with obesity. In all subjects, fasting-induced increases in circulating free fatty acid (FFA) concentrations were associated with an increase in hypothalamic SERT availability and a decrease in striatal DAT availability. Multiple regression analysis showed that changes in plasma insulin and FFAs together accounted for 44% of the observed variation in striatal DAT availability.
CONCLUSION


Lean men respond to prolonged fasting by increasing hypothalamic SERT availability, whereas this response is absent in men with obesity. Inter-individual differences in the adaptations of the cerebral serotonergic and dopaminergic systems to fasting may, in part, be explained by changes in peripheral metabolic signals of fasting, including FFAs and insulin.",2021,"In all subjects, fasting-induced increases in circulating free fatty acid (FFA) concentrations were associated with an increase in hypothalamic SERT availability and a decrease in striatal DAT availability.","['10 lean men and 10 men with obesity', 'men with obesity', 'humans with obesity', 'lean subjects and subjects with obesity', 'lean men', 'Lean men']",[],"['striatal DAT availability', 'hypothalamic SERT availability', 'circulating free fatty acid (FFA) concentrations', 'plasma insulin and FFAs']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]",[],"[{'cui': 'C0114838', 'cui_str': 'Dopamine Transporter'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0170657', 'cui_str': 'Serotonin Transporter'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}]",10.0,0.0466575,"In all subjects, fasting-induced increases in circulating free fatty acid (FFA) concentrations were associated with an increase in hypothalamic SERT availability and a decrease in striatal DAT availability.","[{'ForeName': 'Katy A', 'Initials': 'KA', 'LastName': 'van Galen', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Booij', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Schrantee', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Sofie M', 'Initials': 'SM', 'LastName': 'Adriaanse', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Unga A', 'Initials': 'UA', 'LastName': 'Unmehopa', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fliers', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Schwartz', 'Affiliation': 'Fleischer Institute for Diabetes and Metabolism, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'DiLeone', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Kasper W', 'Initials': 'KW', 'LastName': 'Ter Horst', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Susanne E', 'Initials': 'SE', 'LastName': 'la Fleur', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, Location AMC, Amsterdam, the Netherlands; Laboratory of Endocrinology, Department of Clinical Chemistry, Amsterdam Neuroscience, Amsterdam University Medical Centers, University of Amsterdam, the Netherlands; Netherlands Institute for Neuroscience, An Institute of the Royal Netherlands Academy of Arts and Sciences (KNAW), Amsterdam, the Netherlands.'}, {'ForeName': 'Mireille J', 'Initials': 'MJ', 'LastName': 'Serlie', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, Location AMC, Amsterdam, the Netherlands. Electronic address: m.j.serlie@amsterdamumc.nl.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2021.154839']
1014,34338408,Efficacy and safety of sotagliflozin in patients with type 2 diabetes and severe renal impairment.,"AIMS


To assess the efficacy and safety of sotagliflozin, a dual inhibitor of sodium-glucose cotransporter-1 and -2, in adults with type 2 diabetes (T2D) and stage 4 chronic kidney disease (CKD4).
MATERIALS AND METHODS


This 52-week, phase 3, randomized (1:1:1), placebo-controlled trial evaluated sotagliflozin 200 mg and sotagliflozin 400 mg once daily in 277 patients with T2D and estimated glomerular filtration rate (eGFR) 15 to 30 mL/min/1.73 m 2  . The primary endpoint was glycated haemoglobin (HbA1c) reduction with sotagliflozin 400 mg versus placebo at 26 weeks. A hierarchical statistical testing approach was used.
RESULTS


The baseline mean HbA1c was 65 ± 12 mmol/mol (8.1% ± 1.1%), systolic blood pressure (SBP) was 144 ± 15 mmHg, and eGFR was 24 ± 4 mL/min/1.73m 2  . Placebo-adjusted changes with sotagliflozin 400 mg were -3 mmol/mol (-0.3%; 95% confidence interval -7 to 0.6 [-0.6 to 0.05]; P = 0.096) and -8 mmol/mol (-0.7%; -13 to -3 [-1.2 to -0.2]; P = 0.003) in HbA1c at Weeks 26 and 52, respectively, -1.5 kg (-3.0 to -0.1) in body weight at Week 26, -5.4 mmHg (-9.4 to -1.3) in SBP at Week 12, and -0.3 mL/min/1.73 m 2  (-2.1 to 1.6; P = 0.776) in eGFR at Week 52. Over 52 weeks, 11.8%, 5.4% and 3.3% of patients receiving placebo and sotagliflozin 200 and 400 mg, respectively, required rescue therapy for hyperglycaemia. Adverse events (AEs) occurred in 82.8%, 86.2% and 81.1% of patients and serious cardiovascular AEs occurred in 12.9%, 3.2% and 4.4% of patients in the placebo and sotagliflozin 200 and 400 mg groups, respectively.
CONCLUSIONS


After 26 weeks, HbA1c reductions with sotagliflozin were not statistically significant versus placebo in adults with T2D and CKD4. The 52-week safety profile was consistent with results of the SCORED outcomes trial (NCT03242018).",2021,"After 26 weeks, HbA1c reductions with sotagliflozin were not statistically significant vs placebo in adults with T2D and CKD4.","['277 patients with T2D and estimated glomerular filtration rate (eGFR', 'adults with type 2 diabetes (T2D) and stage 4 chronic kidney disease (CKD4', 'Patients With Type 2 Diabetes and Severe Renal Impairment']","['sotagliflozin', 'Sotagliflozin', 'placebo and sotagliflozin', 'Placebo', 'placebo']","['Efficacy and Safety', 'body weight', 'Adverse events', 'serious cardiovascular adverse events', 'HbA1c reduction', 'systolic blood pressure (SBP), 144±15\u2009mmHg; and eGFR', 'HbA1c reductions with sotagliflozin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C2317473', 'cui_str': 'Chronic kidney disease stage 4'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]","[{'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}]",277.0,0.285169,"After 26 weeks, HbA1c reductions with sotagliflozin were not statistically significant vs placebo in adults with T2D and CKD4.","[{'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ele', 'Initials': 'E', 'LastName': 'Ferrannini', 'Affiliation': 'CNR Institute of Clinical Physiology, Pisa, Italy.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas, USA.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Carroll', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lapuerta', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Banks', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14513']
1015,34342706,Update on Minimally Invasive Surgical Approaches for Rectal Cancer.,"PURPOSE OF REVIEW


This review aims to clarify the current role of minimally invasive surgery in the treatment of rectal cancer, highlighting short- and long-term outcomes from the latest trials and studies.
RECENT FINDINGS


Data from previous trials has been conflicting, with some failing to demonstrate non-inferiority of laparoscopic surgical resection of rectal cancer compared to an open approach and others demonstrating similar clinical outcomes. Robot-assisted surgery was thought to be a promising solution to the challenges faced by laparoscopic surgery, and even though the only randomized controlled trial to date comparing these two techniques did not show superiority of robot-assisted surgery over laparoscopy, more recent retrospective data suggests a statistically significant higher negative circumferential resection margin rate, decreased frequency of conversion to open, and less sexual and urinary complications. Minimally invasive surgery techniques for resection of rectal cancer, particularly robot-assisted, offer clear short-term peri-operative benefits over an open approach; however, current data has yet to display non-inferiority in terms of oncological outcomes.",2021,"Minimally invasive surgery techniques for resection of rectal cancer, particularly robot-assisted, offer clear short-term peri-operative benefits over an open approach; however, current data has yet to display non-inferiority in terms of oncological outcomes.",['Rectal Cancer'],"['minimally invasive surgery', 'Minimally invasive surgery techniques', 'Robot-assisted surgery']",['negative circumferential resection margin rate'],"[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}]",,0.376056,"Minimally invasive surgery techniques for resection of rectal cancer, particularly robot-assisted, offer clear short-term peri-operative benefits over an open approach; however, current data has yet to display non-inferiority in terms of oncological outcomes.","[{'ForeName': 'Leonardo E', 'Initials': 'LE', 'LastName': 'Garcia', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, 600 N Wolfe Street, Blalock, Baltimore, MD, 656, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, 600 N Wolfe Street, Blalock, Baltimore, MD, 656, USA.'}, {'ForeName': 'Chady', 'Initials': 'C', 'LastName': 'Atallah', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, 600 N Wolfe Street, Blalock, Baltimore, MD, 656, USA. catalla3@jhmi.edu.'}]",Current oncology reports,['10.1007/s11912-021-01110-1']
1016,34345969,Pre-emptive oral clarithromycin reduces the skin toxicity of panitumumab treatment for metastatic colorectal cancer.,"PURPOSE


Chemotherapy with panitumumab is expected to be well tolerated and improve survival in patients with metastatic colorectal cancer (mCRC). However, skin toxicities are its most common adverse events. The aim of this trial was to evaluate the efficacy and safety of pre-emptive antibiotic treatment with clarithromycin (CAM) to prevent panitumumab skin toxicities.
METHODS


We conducted a phase lll, multicenter, open-label, randomized clinical trial on mCRC patients treated with panitumumab. Eligible patients were randomly assigned 1:1 to pre-emptive antibiotic and control groups. In the pre-emptive group, CAM administration (200 mg twice per day) continued daily through the panitumumab treatment period. The control regimen consisted of skin care only. The primary end point was the incidence of grade ≥ 2 skin toxicities during the 6-week skin treatment period.
RESULTS


Of 156 enrolled patients, 78 received pre-emptive antibiotic treatment, and 78 received reactive treatment. The number and incidence of grade ≥ 2 skin toxicities during the 6-week skin treatment period were 16 (21.3%) and 41 (54.7%) for the pre-emptive and control groups, respectively (HR, 0.32; 95% CI, 0.17-0.56). There was almost no difference in the rate of other adverse events between the two groups, but the incidence of grade ≥ 3 diarrhea in the pre-emptive group was high, at 8% vs. 1.3% in the control group. There were no treatment-related deaths.
CONCLUSION


Prophylactic oral CAM together with relatively simple skin care was found to be effective in suppressing the development of grade ≥ 2 skin toxicities induced by panitumumab.
CLINICAL TRIAL REGISTRATION


UMIN000011485 DATE OF REGISTRATION: Sep 1st, 2013.",2021,"There was almost no difference in the rate of other adverse events between the two groups, but the incidence of grade ≥ 3 diarrhea in the pre-emptive group was high, at 8% vs. 1.3% in the control group.","['156 enrolled patients, 78 received pre-emptive antibiotic treatment, and 78 received reactive treatment', 'metastatic colorectal cancer', 'mCRC patients treated with', 'Eligible patients', 'patients with metastatic colorectal cancer (mCRC']","['panitumumab', 'clarithromycin', 'clarithromycin (CAM', 'CAM']","['skin toxicities', 'efficacy and safety', 'rate of other adverse events', 'number and incidence of grade\u2009≥\u20092 skin toxicities', 'tolerated and improve survival', 'incidence of grade\u2009≥\u20093 diarrhea', 'skin toxicity', 'incidence of grade\u2009≥\u20092 skin toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",156.0,0.0185682,"There was almost no difference in the rate of other adverse events between the two groups, but the incidence of grade ≥ 3 diarrhea in the pre-emptive group was high, at 8% vs. 1.3% in the control group.","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Nakata', 'Affiliation': 'Department of Surgery, Sakai City Medical Center, Ebaraji-cho 1-1-1, Nishi-ku, Sakai, Osaka, Japan. nakataken@msn.com.'}, {'ForeName': 'Takamichi', 'Initials': 'T', 'LastName': 'Komori', 'Affiliation': 'Department of Gastroenterological Surgery, Hyogo Prefectural Nishinomiya Hospital, Rokutanji-cho 13-9, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Saso', 'Affiliation': 'Department of Surgery, Ashiya Municipal Hospital, Asahigaoka-cho 39-1, Ashiya, Hyogo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Ota', 'Affiliation': 'Department of Gastroenterological Surgery, Ikeda City Hospital, Jounan 3-1-18, Ikeda, Osaka, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kagawa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka General Medical Center, Mandaihigashi 3-1-56, Sumiyoshi-ku, Osaka, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Surgery, Itami City Hospital, Koyaike 1-100, Itami, Hyogo, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Noura', 'Affiliation': 'Department of Surgery, Toyonaka Municipal Hospital, Shibahara-cho 4-14-1, Toyonaka, Osaka, Japan.'}, {'ForeName': 'Nobuyasu', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Department of Surgery, Kinan Hospital, Shinjo-cho 46-70, Tanabe, Wakayama, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka, Japan.'}, {'ForeName': 'Chu', 'Initials': 'C', 'LastName': 'Matsuda', 'Affiliation': 'Department of Surgery, Toyonaka Municipal Hospital, Shibahara-cho 4-14-1, Toyonaka, Osaka, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka, Japan.'}, {'ForeName': 'Tsunekazu', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Murata', 'Affiliation': 'Department of Surgery, Itami City Hospital, Koyaike 1-100, Itami, Hyogo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of colorectal disease,['10.1007/s00384-021-04002-9']
1017,34344019,Cerebral Macro- and Microcirculation during Ephedrine versus Phenylephrine Treatment in Anesthetized Brain Tumor Patients: A Randomized Clinical Trial Using Magnetic Resonance Imaging.,"BACKGROUND


This study compared ephedrine versus phenylephrine treatment on cerebral macro- and microcirculation, measured by cerebral blood flow, and capillary transit time heterogeneity, in anesthetized brain tumor patients. The hypothesis was that capillary transit time heterogeneity in selected brain regions is greater during phenylephrine than during ephedrine, thus reducing cerebral oxygen tension.
METHODS


In this single-center, double-blinded, randomized clinical trial, 24 anesthetized brain tumor patients were randomly assigned to ephedrine or phenylephrine. Magnetic resonance imaging of peritumoral and contralateral hemispheres was performed before and during vasopressor infusion. The primary endpoint was between-group difference in capillary transit time heterogeneity. Secondary endpoints included changes in cerebral blood flow, estimated oxygen extraction fraction, and brain tissue oxygen tension.
RESULTS


Data from 20 patients showed that mean (± SD) capillary transit time heterogeneity in the contralateral hemisphere increased during phenylephrine from 3.0 ± 0.5 to 3.2 ± 0.7 s and decreased during ephedrine from 3.1 ± 0.8 to 2.7 ± 0.7 s (difference phenylephrine versus difference ephedrine [95% CI], -0.6 [-0.9 to -0.2] s; P = 0.004). In the peritumoral region, the mean capillary transit time heterogeneity increased during phenylephrine from 4.1 ± 0.7 to 4.3 ± 0.8 s and decreased during ephedrine from 3.5 ± 0.9 to 3.3 ± 0.9 s (difference phenylephrine versus difference ephedrine [95%CI], -0.4[-0.9 to 0.1] s; P = 0.130). Cerebral blood flow (contralateral hemisphere ratio difference [95% CI], 0.3 [0.06 to 0.54]; P = 0.018; and peritumoral ratio difference [95% CI], 0.3 [0.06 to 0.54; P = 0.018) and estimated brain tissue oxygen tension (contralateral hemisphere ratio difference [95% CI], 0.34 [0.09 to 0.59]; P = 0.001; and peritumoral ratio difference [95% CI], 0.33 [0.09 to 0.57]; P = 0.010) were greater during ephedrine than phenylephrine in both regions.
CONCLUSIONS


Phenylephrine caused microcirculation in contralateral tissue, measured by the change in capillary transit time heterogeneity, to deteriorate compared with ephedrine, despite reaching similar mean arterial pressure endpoints. Ephedrine improved cerebral blood flow and tissue oxygenation in both brain regions and may be superior to phenylephrine in improving cerebral macro- and microscopic hemodynamics and oxygenation.
EDITOR’S PERSPECTIVE


",2021,"Ephedrine improved cerebral blood flow and tissue oxygenation in both brain regions and may be superior to phenylephrine in improving cerebral macro- and microscopic hemodynamics and oxygenation.
","['anesthetized brain tumor patients', '24 anesthetized brain tumor patients', 'Anesthetized Brain Tumor Patients']","['phenylephrine', 'ephedrine or phenylephrine', 'Magnetic Resonance Imaging', 'ephedrine', 'Ephedrine', 'Phenylephrine']","['changes in cerebral blood flow, estimated oxygen extraction fraction, and brain tissue oxygen tension', 'mean (± SD) capillary transit time heterogeneity', 'cerebral macro- and microscopic hemodynamics and oxygenation', 'estimated brain tissue oxygen tension', 'cerebral oxygen tension', 'cerebral blood flow and tissue oxygenation', 'cerebral macro- and microcirculation, measured by cerebral blood flow, and capillary transit time heterogeneity', 'Cerebral Macro- and Microcirculation', 'mean capillary transit time heterogeneity', 'Cerebral blood flow', 'capillary transit time heterogeneity']","[{'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",24.0,0.553584,"Ephedrine improved cerebral blood flow and tissue oxygenation in both brain regions and may be superior to phenylephrine in improving cerebral macro- and microscopic hemodynamics and oxygenation.
","[{'ForeName': 'Klaus U', 'Initials': 'KU', 'LastName': 'Koch', 'Affiliation': 'From the Department of Anesthesiology, Section of Neuroanesthesia, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Irene K', 'Initials': 'IK', 'LastName': 'Mikkelsen', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ulrick S', 'Initials': 'US', 'LastName': 'Espelund', 'Affiliation': 'Department of Anesthesiology, Horsens Regional Hospital, Horsens, Denmark.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Angleys', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tietze', 'Affiliation': 'Institute of Neuroradiology, Charité, Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Gorm V', 'Initials': 'GV', 'LastName': 'Oettingen', 'Affiliation': 'Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Juul', 'Affiliation': 'From the Department of Anesthesiology, Section of Neuroanesthesia, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus, Denmark; the Neuroradiology Research Unit, Section of Neuroradiology, Department of Radiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'From the Department of Anesthesiology, Section of Neuroanesthesia, Aarhus University, Aarhus, Denmark.'}]",Anesthesiology,['10.1097/ALN.0000000000003877']
1018,34347865,Engagement with a digital therapeutic for smoking cessation designed for persons with psychiatric illness fully mediates smoking outcomes in a pilot randomized controlled trial.,"Understanding the mechanisms of change of digital therapeutics is a critical step to improve digital health outcomes and optimize their development. Access to and engagement with digital content is arguably a core mechanism of change of these interventions. However, the mediational role of app engagement has been largely unexamined. To evaluate the mediational effect of engaging with a digital therapeutic for smoking cessation designed for adults with psychiatric disorders. Secondary analysis of a pilot clinical trial of 62 adults with serious mental illness who were randomized to receive either a tailored digital therapeutic (Learn to Quit) or a digital therapeutic for the general public (NCI QuitGuide). Engagement was captured using background analytics of app utilization, including (a) number of interactions with app content, (b) minutes/day of app use, and (c) number of days used. The main outcome was reductions in cigarettes per day from baseline to the four-month endpoint. Mediational analysis followed the Preacher and Hayes bootstrap method. Number of application interactions fully mediated reductions in cigarettes per day in the Learn to Quit application but not in QuitGuide (Average Causal Mediation Effect = .31, p = .02). Minutes/day of app use played an uncertain role, and number of days used was not a significant mediator. Results suggest that one of the mechanisms of action of the Learn to Quit device, engagement with theory-based content, functioned as intended. Future research of digital therapeutics should emphasize granular approaches to evaluating apps' mechanisms of action.",2021,"Number of application interactions fully mediated reductions in cigarettes per day in the Learn to Quit application but not in QuitGuide (Average Causal Mediation Effect = .31, p = .02).","['62 adults with serious mental illness', 'persons with psychiatric illness', 'adults with psychiatric disorders']",['tailored digital therapeutic (Learn to Quit) or a digital therapeutic for the general public (NCI QuitGuide'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0560007', 'cui_str': 'nCi'}]",[],62.0,0.0841347,"Number of application interactions fully mediated reductions in cigarettes per day in the Learn to Quit application but not in QuitGuide (Average Causal Mediation Effect = .31, p = .02).","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Browne', 'Affiliation': 'Geriatric Research, Education and Clinical Center, Durham VA Health Care System, Durham, NC 27705, USA.'}, {'ForeName': 'Tate F', 'Initials': 'TF', 'LastName': 'Halverson', 'Affiliation': 'Durham VA Health Care System, Durham, NC 27705, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Vilardaga', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC 27705, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibab100']
1019,34353696,Assessing the potential correlation of polymorphisms in the IL6R with relative IL6 elevation in severely ill COVID-19 patients'.,"BACKGROUND


Elevated Interleukin-6 (IL-6) may play an important role in the pathophysiology of COVID-19 yet attenuated response is not seen across all severe patients. We aimed to determine the effect of IL-6 baseline levels and other clinical variables on mortality and outcomes in hospitalized COVID-19 patients as well as to explore genetic variants associated with attenuated IL-6 response.
METHODS


Baseline IL-6 cytokine levels were measured in hospitalized patients participating in ongoing ODYSSEY phase 3 randomized study of tradipitant and placebo in hospitalized patients with severe COVID-19 who are receiving supplemental oxygen support. Furthermore blood samples for whole genome sequencing analysis were collected from 150 participants.
RESULTS


We report significantly elevated IL-6 in COVID-19 infected hospitalized patients, n = 100 (p-value < 0.0001) when compared to controls n = 324. We also report a significantly increased level of IL-6 (p-value < 0.01) between the severe and mild COVID-19 patients with severity defined on a WHO scale. Excessive IL-6 plasma levels correlate with higher mortality (p-value 0.001). Additionally, based on our classification analysis, combination of IL-6 elevation and high levels of serum glucose can identify highest risk-group of COVID19 patients. Furthermore, we explore the role of genetic regulatory variants affecting baseline IL-6 levels specifically in COVID-19 patients. We have directly tested the association between variants in the IL6 and IL6R gene region and IL6 plasma levels. We provide results for a common IL-6 variant previously associated with pneumonia, rs1800795, and rs2228145 that was previously shown to affect IL-6 plasma levels, as well as report on novel variants associated with IL-6 plasma levels detected in our study patients.
CONCLUSIONS


While it is unlikely that ""cytokine storm"" is the norm in severe COVID19, baseline elevations above 150 pg/ml may be associated with worst outcomes and as such may warrant treatment considerations. So far no clinical studies used IL-6 baseline assessment to stratify the patient population participating in clinical studies. We believe that careful examination and interpretation of the IL-6 levels and genetic variants can help to determine a patient population with a potentially very robust clinical response to IL-6 inhibition.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT04326426.",2021,We also report a significantly increased level of IL-6 (p-value < 0.01) between the severe and mild COVID-19 patients with severity defined on a WHO scale.,"['hospitalized patients participating in ongoing ODYSSEY phase 3 randomized study of', 'hospitalized COVID-19 patients', 'COVID-19 patients', 'hospitalized patients with severe COVID-19 who are receiving supplemental oxygen support', 'severely ill COVID-19 patients', '150 participants', 'patient population participating in clinical studies']",['tradipitant and placebo'],"['level of IL-6', 'IL-6 elevation and high levels of serum glucose', 'IL-6 cytokine levels', 'IL-6 plasma levels', 'elevated IL-6', 'Excessive IL-6 plasma levels']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}]",,0.258102,We also report a significantly increased level of IL-6 (p-value < 0.01) between the severe and mild COVID-19 patients with severity defined on a WHO scale.,"[{'ForeName': 'Sandra P', 'Initials': 'SP', 'LastName': 'Smieszek', 'Affiliation': 'Vanda Pharmaceuticals Inc., 2200 Pennsylvania NW, Suite 300-E, Washington, DC 20037, United States. Electronic address: sandra.smieszek@vandapharma.com.'}, {'ForeName': 'Bartlomiej P', 'Initials': 'BP', 'LastName': 'Przychodzen', 'Affiliation': 'Vanda Pharmaceuticals Inc., 2200 Pennsylvania NW, Suite 300-E, Washington, DC 20037, United States.'}, {'ForeName': 'Vasilios M', 'Initials': 'VM', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals Inc., 2200 Pennsylvania NW, Suite 300-E, Washington, DC 20037, United States.'}, {'ForeName': 'Christos M', 'Initials': 'CM', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals Inc., 2200 Pennsylvania NW, Suite 300-E, Washington, DC 20037, United States.'}, {'ForeName': 'Mihael H', 'Initials': 'MH', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals Inc., 2200 Pennsylvania NW, Suite 300-E, Washington, DC 20037, United States.'}]",Cytokine,['10.1016/j.cyto.2021.155662']
1020,34352792,Reversal of Root Caries with Casein Phosphopeptide-Amorphous Calcium Phosphate and Fluoride Varnish in Xerostomia.,"Different formulas of topical fluoride have been used to manage root carious lesions. This clinical trial aimed to investigate the efficacy of a dental varnish containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and fluoride compared with fluoride alone in reversing/arresting root caries in xerostomic patients over 1 year. A total of 80 patients (age range 45-92 years) with primary root caries (n = 184 root carious lesions) and unstimulated salivary flow rate of <0.2 mL/min were randomly allocated to receive either dental varnish containing CPP-ACP and 5% fluoride (group 1: MI varnish; GC, Japan) (n = 41, 83 lesions), or dental varnish with 5% fluoride alone (group 2: NUPRO White; Dentsply, USA) (n = 39, 101 lesions). Clinical assessments with Severity Index (SI) for root caries, DIAGNOdent measurements, and varnish application were carried out at baseline, 3, 6, and 12 months. Standard oral hygiene instructions with 1,450 ppm fluoride toothpastes were provided for both groups. After 3 months, 63.9% (n = 46) of root caries in group 1 became hard (SI: 0) compared with 39.3% (n = 35) in group 2 (p < 0.01). After 6 and 12 months, the differences in SI were insignificant (group 1, n = 60, 83.3%) (group 2, n = 66, 74.2%) (p = 0.36), and (group 1, n = 60, 89.6%) (group 2, n = 67, 81.7%, n = 1 soft, 1.2%) (p = 0.29), respectively. In both groups, noncavitated leathery lesions were more likely to become hard when compared to the cavitated root caries. A significant decrease in plaque index, surface roughness, lesion dimension, and DIAGNOdent readings with a significant increase in lesion distance from the gingival margin was reported in both groups (p < 0.05). This study has provided evidence that fluoride dental varnish either with or without calcium and phosphate has the potential to arrest/reverse root caries, especially noncavitated lesions for patients with xerostomia.",2021,"A significant decrease in plaque index, surface roughness, lesion dimension, and DIAGNOdent readings with a significant increase in lesion distance from the gingival margin was reported in both groups (p < 0.05).","['xerostomic patients over 1 year', '80 patients (age range 45-92 years) with primary root caries (n = 184 root carious lesions) and unstimulated salivary flow rate of <0.2 mL/min', 'patients with xerostomia']","['fluoride alone', 'dental varnish containing CPP-ACP and 5% fluoride (group 1: MI varnish; GC, Japan', 'topical fluoride', 'dental varnish with 5% fluoride alone (group 2: NUPRO White; Dentsply, USA', 'Casein Phosphopeptide-Amorphous Calcium Phosphate and Fluoride Varnish', 'dental varnish containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and fluoride']","['reversing/arresting root caries', 'root caries', 'plaque index, surface roughness, lesion dimension', 'lesion distance from the gingival margin', 'SI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162644', 'cui_str': 'Root caries'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0440150', 'cui_str': 'Dental varnish'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0016328', 'cui_str': 'Fluorides, Topical'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0168635', 'cui_str': 'NuPro'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0112984', 'cui_str': 'Dentsply'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0162644', 'cui_str': 'Root caries'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",80.0,0.0363433,"A significant decrease in plaque index, surface roughness, lesion dimension, and DIAGNOdent readings with a significant increase in lesion distance from the gingival margin was reported in both groups (p < 0.05).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sleibi', 'Affiliation': 'Oral Bioengineering, Institute of Dentistry, Queen Mary University of London, London, United Kingdom, dr_ahmedsm75@yahoo.com.'}, {'ForeName': 'Anwar R', 'Initials': 'AR', 'LastName': 'Tappuni', 'Affiliation': 'Centre for Oral Immunobiology and Regenerative Medicine, Institute of Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Baysan', 'Affiliation': 'Oral Bioengineering, Institute of Dentistry, Queen Mary University of London, London, United Kingdom.'}]",Caries research,['10.1159/000516176']
1021,34366153,Effects of Food on the Pharmacokinetic Properties and Mass Balance of Henagliflozin in Healthy Male Volunteers.,"PURPOSE


Henagliflozin is a highly selective and effective sodium glucose co-transporter (SGLT)-2 inhibitor developed for the treatment of patients with type 2 diabetes mellitus (T2DM). This study aimed to investigate the effects of meal intake on the pharmacokinetic properties of henagliflozin, and to understand the excretion pathways of henagliflozin in humans.
METHODS


In this Phase I, randomized, open-label, single-dose, two-period crossover study, 12 healthy male Chinese volunteers were randomized to receive either henagliflozin 10 mg in the fasted condition followed by henagliflozin 10 mg in the fed condition, or the reverse schedule, with the two administrations separated by a washout period of at least 7 days. Samples of blood, urine, and feces were collected and analyzed for the investigation of the pharmacokinetic profile and excretion pathways in the fasted and fed conditions. Any adverse events that occurred throughout the study were recorded for tolerability assessment.
FINDINGS


After the administration of a single oral dose of henagliflozin, mean (SD) plasma AUC 0-∞  and C max  were 1200 (274) h · ng/mL and 179 (48.8) ng/mL, respectively, in the fasted state and were decreased to 971 (245) h · ng/mL and 115 (34.2) ng/mL in the fed state. The fed/fasted ratios (90% CIs) of the geometric mean values of C max , AUC 0-t , and AUC 0-∞  were 64% (54%-76%), 80% (76%-85%), and 80% (76%-85%), respectively. The median (range) T max  was prolonged from 1.5 (1-3) hours in the fasted condition to 2 (1.5-6) hours in the fed condition. Mass-balance testing revealed that henagliflozin was eliminated primarily as the parent drug in feces and as glucuronide metabolites in urine. In the fasted state, the cumulative excretion percentages of the parent drug and its metabolites to dose in feces and urine were 40.6% and 33.9%, respectively. The values in the fed condition were changed to 50.4% and 25.5%, respectively. These findings suggest that postprandial administration decreases the absorption rate and the extent of henagliflozin exposure in humans, but has no effect on the metabolism or elimination of the drug.
IMPLICATIONS


In the present study, the consumption of a high-fat meal prior to henagliflozin administration was associated with reductions in AUC 0-∞  and C max  of 19.4% and 36.4%, respectively. However, based on the analysis of the pharmacokinetic/pharmacodynamic findings on henagliflozin, this slight change may not have clinical significance. Mass balance of henagliflozin in humans was achieved with ∼75% of the administered dose recovered in excretions within 4 days after administration whether in the fasted or fed state. These findings suggest that henagliflozin tablets can be administered with or without food.",2021,The median (range) T max  was prolonged from 1.5 (1-3) hours in the fasted condition to 2 (1.5-6) hours in the fed condition.,"['patients with type 2 diabetes mellitus (T2DM', 'humans', 'Healthy Male Volunteers', '12 healthy male Chinese volunteers']","['henagliflozin', 'henagliflozin 10 mg in the fasted condition followed by henagliflozin', 'henagliflozin tablets', 'Henagliflozin']","['absorption rate', 'cumulative excretion percentages', 'tolerability assessment', 'median (range) T max', 'Mass balance of henagliflozin', 'geometric mean values of C max , AUC 0-t , and AUC 0-∞', 'Pharmacokinetic Properties and Mass Balance of Henagliflozin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C4309480', 'cui_str': 'henagliflozin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4309480', 'cui_str': 'henagliflozin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",12.0,0.0605815,The median (range) T max  was prolonged from 1.5 (1-3) hours in the fasted condition to 2 (1.5-6) hours in the fed condition.,"[{'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Shanghai Xuhui Central Hospital, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Yun-Ting', 'Initials': 'YT', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Yi-Fan', 'Initials': 'YF', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Chen', 'Affiliation': 'Shanghai Xuhui Central Hospital, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Shanghai Xuhui Central Hospital, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Jing-Ying', 'Initials': 'JY', 'LastName': 'Jia', 'Affiliation': 'Shanghai Xuhui Central Hospital, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Shanghai Xuhui Central Hospital, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Hengrui Pharmaceuticals Company Ltd, Lianyungang, China.'}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Pharmaceuticals Company Ltd, Lianyungang, China.'}, {'ForeName': 'Yan-Mei', 'Initials': 'YM', 'LastName': 'Liu', 'Affiliation': 'Shanghai Xuhui Central Hospital, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China. Electronic address: ymliu@shxh-centerlab.com.'}, {'ForeName': 'Da-Fang', 'Initials': 'DF', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China. Electronic address: dfzhong@simm.ac.cn.'}]",Clinical therapeutics,['10.1016/j.clinthera.2021.07.008']
1022,34369902,"Effect of Miricorilant, a Selective Glucocorticoid Receptor Modulator, on Olanzapine-Associated Weight Gain in Healthy Subjects: A Proof-of-Concept Study.","PURPOSE


Antipsychotic medications, including olanzapine, are associated with substantial weight gain and metabolic disturbances. We sought to determine whether coadministration of miricorilant, a selective glucocorticoid receptor modulator, with olanzapine can ameliorate these effects.
METHODS


Sixty-six healthy men were enrolled in a 2-week, randomized, double-blind, placebo-controlled trial. The primary objective was to evaluate changes in body weight after 14 days coadministration of olanzapine (10 mg) + miricorilant (600 mg) compared with olanzapine (10 mg) + placebo. Secondary objectives included evaluating (a) the safety and tolerability of the combination; (b) the effects of the combination on glucose, insulin, insulin resistance, and triglycerides; and (c) the impact of the combination on hepatic enzymes.
RESULTS


Subjects administered olanzapine + miricorilant gained less weight than subjects administered olanzapine + placebo (mean weight gain on day 15, 3.91 kg vs 4.98 kg; difference between groups, -1.07 kg; 95% confidence interval, -1.94 to -0.19; P = 0.017]). Compared with the placebo group, coadministration of miricorilant with olanzapine was associated with smaller increases in insulin (difference, -3.74 mIU/L; P = 0.007), homeostatic model assessment of insulin resistance (difference, -0.47; P = 0.007), triglycerides (difference, -0.29 mmol/L; P = 0.057), aspartate aminotransferase (difference, -32.24 IU/L; P = 0.009), and alanine aminotransferase (difference, -49.99 IU/L; P = 0.030).
CONCLUSIONS


Miricorilant may provide a promising option for ameliorating the detrimental effects of olanzapine, and investigation of this medication in patients affected by antipsychotic-induced weight gain is warranted. Two phase 2 studies of miricorilant in patients with recent and long-standing antipsychotic-induced weight gain are currently in progress.",2021,"Compared with the placebo group, coadministration of miricorilant with olanzapine was associated with smaller increases in insulin (difference, -3.74 mIU/L; P = 0.007), homeostatic model assessment of insulin resistance (difference, -0.47; P = 0.007), triglycerides (difference, -0.29 mmol/L; P = 0.057), aspartate aminotransferase (difference, -32.24 IU/L; P = 0.009), and alanine aminotransferase (difference, -49.99 IU/L; P = 0.030).
","['Healthy Subjects', 'Sixty-six healthy men', 'patients with recent and long-standing antipsychotic-induced weight gain']","['Olanzapine', 'olanzapine (10 mg) + miricorilant', 'olanzapine', 'olanzapine + placebo', 'placebo', 'Miricorilant, a Selective Glucocorticoid Receptor Modulator', 'olanzapine (10 mg) + placebo']","['aspartate aminotransferase', 'body weight', 'triglycerides', 'alanine aminotransferase', 'substantial weight gain and metabolic disturbances', 'homeostatic model assessment of insulin resistance', 'weight', 'safety and tolerability of the combination; (b) the effects of the combination on glucose, insulin, insulin resistance, and triglycerides; and (c) the impact of the combination on hepatic enzymes', 'insulin']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034809', 'cui_str': 'Glucocorticoid receptor'}]","[{'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}]",66.0,0.340982,"Compared with the placebo group, coadministration of miricorilant with olanzapine was associated with smaller increases in insulin (difference, -3.74 mIU/L; P = 0.007), homeostatic model assessment of insulin resistance (difference, -0.47; P = 0.007), triglycerides (difference, -0.29 mmol/L; P = 0.057), aspartate aminotransferase (difference, -32.24 IU/L; P = 0.009), and alanine aminotransferase (difference, -49.99 IU/L; P = 0.030).
","[{'ForeName': 'Hazel J', 'Initials': 'HJ', 'LastName': 'Hunt', 'Affiliation': 'From Corcept Therapeutics, Menlo Park, CA.'}, {'ForeName': 'Kirsteen', 'Initials': 'K', 'LastName': 'Donaldson', 'Affiliation': 'Jade Consultants (Cambridge) Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Strem', 'Affiliation': 'From Corcept Therapeutics, Menlo Park, CA.'}, {'ForeName': 'Iulia Cristina', 'Initials': 'IC', 'LastName': 'Tudor', 'Affiliation': 'From Corcept Therapeutics, Menlo Park, CA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Sweet-Smith', 'Affiliation': 'Jade Consultants (Cambridge) Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Sharan', 'Initials': 'S', 'LastName': 'Sidhu', 'Affiliation': 'Quotient Sciences, Nottingham, United Kingdom.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001470']
1023,34373566,Association of Troponin T levels and functional outcome 3 months after subarachnoid hemorrhage.,"TroponinT levels are frequently elevated after subarachnoid hemorrhage (SAH). However, their clinical impact on long term outcomes still remains unclear. This study evaluates the association of TroponinT and functional outcomes 3 months after SAH. Data were obtained in the frame of a randomized controlled trial exploring the association of Goal-directed hemodynamic therapy and outcomes after SAH (NCT01832389). TroponinT was measured daily for the first 14 days after admission or until discharge from the ICU. Outcome was assessed using Glasgow Outcome Scale (GOS) 3 months after discharge. Logistic regression was used to explore the association between initial TroponinT values stratified by tertiles and admission as well as outcome parameters. TroponinT measurements were analyzed in 105 patients. TroponinT values at admission were associated with outcome assessed by GOS in a univariate analysis. TroponinT was not predictive of vasospasm or delayed cerebral ischemia, but an association with pulmonary and cardiac complications was observed. After adjustment for age, history of arterial hypertension and World Federation of Neurosurgical Societies (WFNS) grade, TroponinT levels at admission were not independently associated with worse outcome (GOS 1-3) or death at 3 months. In summary, TroponinT levels at admission are associated with 3 months-GOS but have limited ability to independently predict outcome after SAH.",2021,"TroponinT was not predictive of vasospasm or delayed cerebral ischemia, but an association with pulmonary and cardiac complications was observed.","['subarachnoid hemorrhage', '105 patients']",['TroponinT'],"['Glasgow Outcome Scale (GOS', 'arterial hypertension and World Federation of Neurosurgical Societies (WFNS) grade, TroponinT levels at admission', 'vasospasm or delayed cerebral ischemia', 'TroponinT levels', 'TroponinT values at admission', 'TroponinT measurements']","[{'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",105.0,0.146682,"TroponinT was not predictive of vasospasm or delayed cerebral ischemia, but an association with pulmonary and cardiac complications was observed.","[{'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Anetsberger', 'Affiliation': 'Department of Anesthesiology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Jungwirth', 'Affiliation': 'Department of Anesthesiology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Blobner', 'Affiliation': 'Department of Anesthesiology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ringel', 'Affiliation': 'Department of Neurosurgery, Universitätsmedizin Mainz, Langenbeckstr.1, 55131, Mainz, Germany.'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Bernlochner', 'Affiliation': 'I. Medizinische Klinik und Poliklinik, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heim', 'Affiliation': 'Department of Anesthesiology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Bogdanski', 'Affiliation': 'Department of Anesthesiology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wostrack', 'Affiliation': 'Department of Neurosurgery, Klinikum Rechts der Isar, Technical University Munich, Ismaninger Str.22, 81675, Munich, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schneider', 'Affiliation': 'Department of Anesthesiology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Department of Neurosurgery, Klinikum Rechts der Isar, Technical University Munich, Ismaninger Str.22, 81675, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Graeßner', 'Affiliation': 'Department of Anesthesiology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Baumgart', 'Affiliation': 'Department of Neurosurgery, Klinikum Rechts der Isar, Technical University Munich, Ismaninger Str.22, 81675, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gempt', 'Affiliation': 'Department of Neurosurgery, Klinikum Rechts der Isar, Technical University Munich, Ismaninger Str.22, 81675, Munich, Germany. jens.gempt@tum.de.'}]",Scientific reports,['10.1038/s41598-021-95717-w']
1024,34379791,Interventions for tophi in gout.,"BACKGROUND


Tophi develop in untreated or uncontrolled gout. This is an update of a Cochrane Review first published in 2014.  OBJECTIVES: To assess the benefits and harms of non-surgical and surgical treatments for the management of tophi in gout.
SEARCH METHODS


We updated the search of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase databases to 28 August 2020.
SELECTION CRITERIA


We included all published randomised controlled trials (RCTs) or controlled clinical trials examining interventions for tophi in gout in adults.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane.
MAIN RESULTS


We included one trial in our original review. We added four more trials (1796 participants) in this update. One had three arms; pegloticase infusion every two weeks (biweekly), monthly pegloticase infusion (pegloticase infusion alternating with placebo infusion every two weeks) and placebo. Two studies looked at lesinurad 200 mg or 400 mg in combination with allopurinol. One trial studied lesinurad 200 mg or 400 mg in combination with febuxostat. One trial compared febuxostat 80 mg and 120 mg to allopurinol. Two trials were at unclear risk of performance and detection bias due to lack of information on blinding of participants and personnel. All other trials were at low risk of bias. Moderate-certainty evidence (downgraded for imprecision; one study; 79 participants) showed that biweekly pegloticase resolved tophi in 21/52 participants compared with 2/27 on placebo (risk ratio (RR) 5.45, 95% confidence interval (CI) 1.38 to 21.54; number needed to treat for a benefit (NNTB) 3, 95% CI 2 to 6). Similar proportions of participants receiving biweekly pegloticase (80/85) had an adverse event compared to placebo (41/43) (RR 0.99, 95% CI 0.91 to 1.07). However, more participants on biweekly pegloticase (15/85) withdrew due to an adverse event compared to placebo (1/43) (RR 7.59, 95% CI 1.04 to 55.55; number needed to treat for a harm (NNTH) 7, 95% CI 4 to 16). More participants on monthly pegloticase (11/52) showed complete resolution of tophi compared with placebo (2/27) (RR 2.86, 95% CI 0.68 to 11.97; NNTB 8, 95% CI 4 to 91). Similar numbers of participants on monthly pegloticase (84/84) had an adverse event compared to placebo (41/43) (RR 1.05, 95% CI 0.98 to 1.14). More participants on monthly pegloticase (16/84) withdrew due to adverse events compared to placebo (1/43) (RR 8.19, 95% CI 1.12 to 59.71; NNTH 6, 95% CI 4 to 14). Infusion reaction was the most common reason for withdrawal. Moderate-certainty evidence (2 studies; 103 participants; downgraded for imprecision) showed no clinically significant difference for complete resolution of target tophus in the lesinurad 200 mg plus allopurinol arm (11/53) compared to the placebo plus allopurinol arm (16/50) (RR 0.40, 95% CI 0.04 to 4.57), or in the lesinurad 400 mg plus allopurinol arm (12/48) compared to the placebo plus allopurinol arm (16/50) (RR 0.79, 95% CI 0.42 to 1.49). An extension study examined lesinurad 200 mg or 400 mg in combination with febuxostat, or placebo (low-certainty evidence, downgraded for indirectness and imprecision). Participants on lesinurad in the original study continued (CONT) on the same dose. Lesinurad 400 mg plus febuxostat may be beneficial for tophi resolution; 43/65 in the lesinurad 400 mg CONT arm compared to 38/64 in the lesinurad 200 mg CONT arm had tophi resolution (RR 1.11, 95% CI 0.85 to 1.46). Lesinurad 400 mg plus febuxostat may result in no difference in adverse events; 57/65 in the lesinurad 400 mg CONT arm had an adverse event compared to 50/64 in lesinurad 200 mg CONT arm (RR 1.12, 95% CI 0.96 to 1.32). Lesinurad 400 mg plus febuxostat may result in no difference in withdrawals due to adverse events; 10/65 participants in the lesinurad 400 mg CONT arm withdrew due to an adverse event compared to 10/64 participants in the lesinurad 200 mg CONT arm (RR 0.98, 95% CI 0.44 to 2.20). Lesinurad 400 mg plus febuxostat may result in no difference in mean serum uric acid (sUA), which was 3 mg/dl in the lesinurad 400 mg CONT group compared to 3.9 mg/dl in the lesinurad 200 mg CONT group (mean difference -0.90, 95% CI -1.51 to -0.29). Participants who were not on lesinurad in the original study were randomised (CROSS) to lesinurad 200 mg or 400 mg, both in combination with febuxostat. Low-certainty evidence downgraded for indirectness and imprecision showed that lesinurad 400 mg (CROSS) may result in tophi resolution (17/34) compared to lesinurad 200 mg (CROSS) (14/33) (RR 1.18, 95% CI 0.70 to 1.98). Lesinurad 400 mg in combination with febuxostat may result in no difference in adverse events (33/34 in the lesinurad 400 mg CROSS arm compared to 27/33 in the lesinurad 200 mg (CROSS); RR 1.19, 95% CI 1.00 to 1.41). Lesinurad 400 mg plus febuxostat may result in no difference in withdrawals due to adverse events, 5/34 in the lesinurad 400 mg CROSS arm withdrew compared to 2/33 in the lesinurad 200 mg CROSS arm (RR 2.43, 95% CI 0.51 to 11.64). Lesinurad 400 mg plus febuxostat results in no difference in sUA (4.2 mg/dl in lesinurad 400 mg CROSS) compared to lesinurad 200 mg (3.8 mg/dl in lesinurad 200 mg CROSS), mean difference 0.40 mg/dl, 95% CI -0.75 to 1.55.
AUTHORS' CONCLUSIONS


Moderate-certainty evidence showed that pegloticase is probably beneficial for resolution of tophi in gout. Although there was little difference in adverse events when compared to placebo, participants on pegloticase had more withdrawals due to adverse events. Lesinurad 400 mg plus febuxostat may be beneficial for tophi resolution compared with lesinurad 200 mg plus febuxostat; there was no difference in adverse events between these groups. We were unable to determine whether lesinurad plus febuxostat is more effective than placebo. Lesinurad (400 mg or 200 mg) plus allopurinol is probably not beneficial for tophi resolution, and there was no difference in adverse events between these groups. RCTs on interventions for managing tophi in gout are needed, and the lack of trial data is surprising given that allopurinol is a well-established treatment for gout.",2021,"Although there was little difference in adverse events when compared to placebo, participants on pegloticase had more withdrawals due to adverse events. ","['28 August 2020', 'tophi in gout in adults', 'Participants who were not on lesinurad in the original study']","['lesinurad 200 mg or 400 mg in combination with febuxostat, or placebo', 'pegloticase infusion (pegloticase infusion alternating with placebo', 'placebo plus allopurinol', 'Lesinurad 400 mg plus febuxostat', 'febuxostat', 'allopurinol', 'placebo', 'RCTs', 'lesinurad 200 mg or 400 mg in combination with febuxostat']","['complete resolution of target tophus', 'complete resolution of tophi', 'adverse events', 'tophi resolution', 'adverse event', 'mean serum uric acid (sUA', 'sUA']","[{'cui': 'C0221248', 'cui_str': 'Tophus'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3886073', 'cui_str': 'lesinurad'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4074452', 'cui_str': 'lesinurad 200 MG [Zurampic]'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2350656', 'cui_str': 'Pegloticase'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C3886073', 'cui_str': 'lesinurad'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0221248', 'cui_str': 'Tophus'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}]",79.0,0.56,"Although there was little difference in adverse events when compared to placebo, participants on pegloticase had more withdrawals due to adverse events. ","[{'ForeName': 'Melonie K', 'Initials': 'MK', 'LastName': 'Sriranganathan', 'Affiliation': 'Rheumatology Service, Department of General Medicine, Changi General Hospital, Singapore City, Singapore.'}, {'ForeName': 'Ophir', 'Initials': 'O', 'LastName': 'Vinik', 'Affiliation': ""Division of Rheumatology, St Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Pardo Pardo', 'Affiliation': 'Ottawa Hospital Research Institute, The Ottawa Hospital - General Campus, Ottawa, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bombardier', 'Affiliation': 'Toronto General Research Institute, University Health Network, Toronto, Canada.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Edwards', 'Affiliation': 'Department of Rheumatology, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010069.pub3']
1025,34381108,Differential and shared effects of eicosapentaenoic acid and docosahexaenoic acid on serum metabolome in subjects with chronic inflammation.,"The omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) affect cell function and metabolism, but the differential effects of EPA and DHA are not known. In a randomized, controlled, double-blind, crossover study, we assessed the effects of 10-week supplementation with EPA-only and DHA-only (3 g/d), relative to a 4-week lead-in phase of high oleic acid sunflower oil (3 g/day, defined as baseline), on fasting serum metabolites in 21 subjects (9 men and 12 post-menopausal women) with chronic inflammation and some characteristics of metabolic syndrome. Relative to baseline, EPA significantly lowered the tricarboxylic acid (TCA) cycle intermediates fumarate and α-ketoglutarate and increased glucuronate, UDP-glucuronate, and non-esterified DHA. DHA significantly lowered the TCA cycle intermediates pyruvate, citrate, isocitrate, fumarate, α-ketoglutarate, and malate, and increased succinate and glucuronate. Pathway analysis showed that both EPA and DHA significantly affected the TCA cycle, the interconversion of pentose and glucuronate, and alanine, and aspartate and glutamate pathways (FDR < 0.05) and that DHA had a significantly greater effect on the TCA cycle than EPA. Our results indicate that EPA and DHA exhibit both common and differential effects on cell metabolism in subjects with chronic inflammation and some key aspects of metabolic syndrome.",2021,"DHA significantly lowered the TCA cycle intermediates pyruvate, citrate, isocitrate, fumarate, α-ketoglutarate, and malate, and increased succinate and glucuronate.","['21 subjects (9 men and 12 post-menopausal women) with chronic inflammation and some characteristics of metabolic syndrome', 'subjects with chronic inflammation']","['eicosapentaenoic acid and docosahexaenoic acid', 'omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', '10-week supplementation with EPA-only and DHA-only (3\xa0g/d), relative to a 4-week lead-in phase of high oleic acid sunflower oil']","['tricarboxylic acid (TCA) cycle intermediates fumarate and α-ketoglutarate and increased glucuronate, UDP-glucuronate, and non-esterified DHA', 'serum metabolome', 'TCA cycle intermediates pyruvate, citrate, isocitrate, fumarate, α-ketoglutarate, and malate, and increased succinate and glucuronate', 'TCA cycle, the interconversion of pentose and glucuronate, and alanine, and aspartate and glutamate pathways', 'cell metabolism']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0051395', 'cui_str': 'alpha-ketoglutaric acid'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0017774', 'cui_str': 'Glucosiduronates'}, {'cui': 'C0041986', 'cui_str': 'Uridine diphosphate'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0008858', 'cui_str': 'Krebs cycle pathway'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0022160', 'cui_str': 'Isocitrates'}, {'cui': 'C0024546', 'cui_str': 'Malates'}, {'cui': 'C0038617', 'cui_str': 'Succinates'}, {'cui': 'C0030894', 'cui_str': 'Pentose'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",21.0,0.15326,"DHA significantly lowered the TCA cycle intermediates pyruvate, citrate, isocitrate, fumarate, α-ketoglutarate, and malate, and increased succinate and glucuronate.","[{'ForeName': 'Wan-Chi', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': 'Cardiovascular Nutrition Laboratory, Jean Mayer USDA Human Nutrition Research Center On Aging, Tufts University, 711 Washington Street, Boston, MA, 02111, USA.'}, {'ForeName': 'Jisun', 'Initials': 'J', 'LastName': 'So', 'Affiliation': 'Cardiovascular Nutrition Laboratory, Jean Mayer USDA Human Nutrition Research Center On Aging, Tufts University, 711 Washington Street, Boston, MA, 02111, USA.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Lamon-Fava', 'Affiliation': 'Cardiovascular Nutrition Laboratory, Jean Mayer USDA Human Nutrition Research Center On Aging, Tufts University, 711 Washington Street, Boston, MA, 02111, USA. stefania.lamon-fava@tufts.edu.'}]",Scientific reports,['10.1038/s41598-021-95590-7']
1026,34380871,Characteristics of patients who underwent gastric electrical stimulation vs. surgical pyloric interventions for refractory gastroparesis.,"Background


There has been recent debate comparing the efficacy of gastric electrical stimulation (GES) with pyloric intervention, but medical literature lacks clear indications for when to perform GES or pyloric intervention. This study aims to assess the effect of sociodemographic factors and hospital characteristics on the surgical technique chosen for the treatment of gastroparesis.
Methods


Data was extracted from the National Inpatient Sample between the years 2012 and 2014, using any discharge diagnosis of gastroparesis. For comparison of analysis between GES and pyloric surgical intervention, pyloroplasty, endoscopic pyloric dilation, and pyloromyotomy were considered to be pyloric interventions. The study population was divided into two groups, one which received GES and the other receiving pyloric intervention, to compare socioeconomic factors and hospital characteristics.
Results


In total, 737,930 hospitalizations had a discharge diagnosis of gastroparesis between 2012 and 2014. On weighted multivariant analysis of patients undergoing GES or pyloric intervention for gastroparesis, being female (odds ratio (OR) 1.49, 95% confidence interval (CI) 1.25-1.78; P < 0.001), being Hispanic (OR 1.75, 95%CI; P < 0.001), being in urban teaching (OR 1.41, 95%CI 1.15-1.72; P < 0.001), and nonteaching hospitals (OR 2.93, 95%CI 2.4-3.58; P < 0.001), early satiety (OR 6.70, 95%CI 1.54-31.25; P = 0.01), and diabetes mellitus (OR 2.14, 95%CI 1.78-2.56; P < 0.001) were each statistically significantly correlated with receiving GES intervention compared to pyloric intervention.
Conclusion


The racial difference, payer source, and hospital location affected the surgical intervention (GES or pyloric intervention) that patients with gastroparesis would receive.",2021,"The racial difference, payer source, and hospital location affected the surgical intervention (GES or pyloric intervention) that patients with gastroparesis would receive.","['National Inpatient Sample between the years 2012 and 2014, using any discharge diagnosis of gastroparesis', 'In total, 737,930 hospitalizations had a discharge diagnosis of gastroparesis between 2012 and 2014']","['GES intervention', 'gastric electrical stimulation (GES) with pyloric intervention', 'gastric electrical stimulation vs. surgical pyloric interventions', 'GES or pyloric intervention', 'GES and the other receiving pyloric intervention']","['diabetes mellitus', 'early satiety']","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C4761037', 'cui_str': 'Gastric electrical stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0239233', 'cui_str': 'Early satiety'}]",737930.0,0.10884,"The racial difference, payer source, and hospital location affected the surgical intervention (GES or pyloric intervention) that patients with gastroparesis would receive.","[{'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Department of Internal Medicine, Sunrise Hospital and Medical Center, Las Vegas, NV, United States.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Hussain', 'Affiliation': 'Department of Internal Medicine, SUNY Downstate Medical Center, Brooklyn, NY, United States.'}, {'ForeName': 'Mohd A', 'Initials': 'MA', 'LastName': 'Alsamman', 'Affiliation': 'Department of Gastroenterology, Georgetown University, Washington, D.C, United States.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Inayat', 'Affiliation': 'Department of Internal Medicine, Allama Iqbal Medical College, Lahore, Pakistan.'}, {'ForeName': 'Jasndeep', 'Initials': 'J', 'LastName': 'Kaler', 'Affiliation': 'Department of Internal Medicine, Xavier University School of Medicine, Oranjestad, Aruba.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Tansel', 'Affiliation': 'Department of Gastroenterology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Abell L', 'Initials': 'AL', 'LastName': 'Thomas', 'Affiliation': 'Department of Gastroenterology, University of Louisville, KY, United States.'}]",Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association,['10.4103/sjg.sjg_673_20']
1027,34342299,"Open Preperitoneal Inguinal Hernia Repair, TREPP Versus TIPP in a Randomized Clinical Trial.","OBJECTIVE


The aim of this study was to compare chronic postoperative inguinal pain (CPIP) in patients with an inguinal hernia after the TransREctus Sheath PrePeritoneal (TREPP) and the TransInguinal PrePeritoneal Technique (TIPP).
BACKGROUND


The preperitoneal mesh position for inguinal hernia repair showed beneficial results regarding CPIP with low recurrence rates. Two open preperitoneal techniques, TREPP and TIPP, were compared in a randomized clinical trial with the hypothesis of fewer patients with CPIP after TREPP due to complete avoidance of nerve contact.
METHODS


Adult patients with a primary unilateral inguinal hernia were randomized to either TREPP or TIPP in four hospitals. Before the trial's start the study protocol was ethically approved and published. Outcomes included CPIP after 1 year (primary outcome) and recurrence rates, adverse events, and health-related quality of life (secondary outcomes). Follow-up was performed at 2 weeks, 6 months, and 1 year.
RESULTS


Baseline characteristics were comparable in both groups. Pain was less often present after TREPP at 2 weeks and 6 months, but CPIP at rest at 1 year was comparable: 1.9% after TREPP vs 1.4% after TIPP, P = 0.535). The overall recurrence rate was higher in the TREPP group, 8.9% vs 4.6%, P = 0.022). Corrected for a learning curve for TREPP, no significant difference could be assessed (TREPP 5.7% and TIPP 4.8%, P = 0.591).
CONCLUSION


Both the TREPP and TIPP technique resulted in a low incidence of CPIP after 1-year follow-up. The TREPP method can be considered a solid method for inguinal hernia repair if expertise is present. The learning curve of the TREPP techniques needs further evaluation.
TRIAL REGISTRATION


ISRCTN18591339.",2021,"The overall recurrence rate was higher in the TREPP group, 8.9% vs 4.6%, p=0.022).","['Adult patients with a primary unilateral inguinal hernia', 'patients with CPIP after TREPP due to complete avoidance of nerve contact', 'patients with an inguinal hernia after the']","['Chronic Postoperative Inguinal Pain (CPIP', 'TransInguinal preperitoneal technique', 'TREPP and TIPP technique', 'TREPP and TIPP', 'TREPP', 'Open Preperitoneal Inguinal Hernia Repair, TREPP versus TIPP', 'ESA congress', 'TREPP or TIPP', 'TransREctus Sheath PrePeritoneal (TREPP']","['Pain', 'CPIP', 'recurrence rates, adverse events and Health related Quality of Life (secondary outcomes', 'overall recurrence rate', ""titled 'Chronic inguinal pain""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0442357', 'cui_str': 'Inguinal approach'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0218316', 'cui_str': 'tyrosyl-1,2,3,4-tetrahydro-3-isoquinolinecarbonyl-phenylalanyl-phenylalanine'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0282415', 'cui_str': 'Congresses'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.423179,"The overall recurrence rate was higher in the TREPP group, 8.9% vs 4.6%, p=0.022).","[{'ForeName': 'Willem J V', 'Initials': 'WJV', 'LastName': 'Bökkerink', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Giel G', 'Initials': 'GG', 'LastName': 'Koning', 'Affiliation': 'Department of Surgery, ZGT Hospital Almelo, Almelo, the Netherlands.'}, {'ForeName': 'Patrick W H E', 'Initials': 'PWHE', 'LastName': 'Vriens', 'Affiliation': 'Department of Surgery, Elisabeth Tweesteden Hospital, Tilburg, the Netherlands.'}, {'ForeName': 'Roland M H G', 'Initials': 'RMHG', 'LastName': 'Mollen', 'Affiliation': 'Department of Surgery, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Mitchell J R', 'Initials': 'MJR', 'LastName': 'Harker', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Noordhof', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Willem L', 'Initials': 'WL', 'LastName': 'Akkersdijk', 'Affiliation': 'Department of Surgery, St Jansdal Hospital, Harderwijk, the Netherlands.'}, {'ForeName': 'Cees J H M', 'Initials': 'CJHM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",Annals of surgery,['10.1097/SLA.0000000000005130']
1028,34347008,Effect of Exercise Training on Ambulatory Blood Pressure Among Patients With Resistant Hypertension: A Randomized Clinical Trial.,"Importance


Limited evidence suggests exercise reduces blood pressure (BP) in individuals with resistant hypertension, a clinical population with low responsiveness to drug therapy.
Objective


To determine whether an aerobic exercise training intervention reduces ambulatory BP among patients with resistant hypertension.
Design, Settings, and Participants


The Exercise Training in the Treatment of Resistant Hypertension (EnRicH) trial is a prospective, 2-center, single-blinded randomized clinical trial performed at 2 hospital centers in Portugal from March 2017 to December 2019. A total of 60 patients with a diagnosis of resistant hypertension aged 40 to 75 years were prospectively enrolled and observed at the hospitals' hypertension outpatient clinic.
Interventions


Patients were randomly assigned in a 1:1 ratio to a 12-week moderate-intensity aerobic exercise training program (exercise group) or a usual care control group. The exercise group performed three 40-minute supervised sessions per week in addition to usual care.
Main Outcomes and Measures


The powered primary efficacy measure was 24-hour ambulatory systolic BP change from baseline. Secondary outcomes included daytime and nighttime ambulatory BP, office BP, and cardiorespiratory fitness.
Results


A total of 53 patients completed the study, including 26 in the exercise group and 27 in the control group. Of these, 24 (45%) were women, and the mean (SD) age was 60.1 (8.7) years. Compared with the control group, among those in the exercise group, 24-hour ambulatory systolic BP was reduced by 7.1 mm Hg (95% CI, -12.8 to -1.4; P = .02). Additionally, 24-hour ambulatory diastolic BP (-5.1 mm Hg; 95% CI, -7.9 to -2.3; P = .001), daytime systolic BP (-8.4 mm Hg; 95% CI, -14.3 to -2.5; P = .006), and daytime diastolic BP (-5.7 mm Hg; 95% CI, -9.0 to -2.4; P = .001) were reduced in the exercise group compared with the control group. Office systolic BP (-10.0 mm Hg; 95% CI, -17.6 to -2.5; P = .01) and cardiorespiratory fitness (5.05 mL/kg per minute of oxygen consumption; 95% CI, 3.5 to 6.6; P < .001) also improved in the exercise group compared with the control group.
Conclusions and Relevance


A 12-week aerobic exercise program reduced 24-hour and daytime ambulatory BP as well as office systolic BP in patients with resistant hypertension. These findings provide clinicians with evidence to embrace moderate-intensity aerobic exercise as a standard coadjutant therapy targeting this patient population.
Trial Registration


ClinicalTrials.gov Identifier: NCT03090529.",2021,"Compared with the control group, among those in the exercise group, 24-hour ambulatory systolic BP was reduced by 7.1 mm Hg (95% CI, -12.8 to -1.4; P = .02).","['Patients With Resistant Hypertension', '24 (45%) were women, and the mean (SD) age was 60.1 (8.7) years', '53 patients completed the study, including 26 in the exercise group and 27 in the control group', 'individuals with resistant hypertension', '2 hospital centers in Portugal from March 2017 to December 2019', 'patients with resistant hypertension', ""60 patients with a diagnosis of resistant hypertension aged 40 to 75 years were prospectively enrolled and observed at the hospitals' hypertension outpatient clinic""]","['moderate-intensity aerobic exercise training program (exercise group) or a usual care control group', 'Exercise Training', 'aerobic exercise training intervention', 'aerobic exercise program']","['daytime systolic BP', '24-hour ambulatory systolic BP', '24-hour ambulatory diastolic BP', 'cardiorespiratory fitness', '24-hour ambulatory systolic BP change', '24-hour and daytime ambulatory BP', 'daytime diastolic BP', 'Office systolic BP', 'blood pressure (BP', 'daytime and nighttime ambulatory BP, office BP, and cardiorespiratory fitness', 'ambulatory BP', 'Ambulatory Blood Pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",60.0,0.102171,"Compared with the control group, among those in the exercise group, 24-hour ambulatory systolic BP was reduced by 7.1 mm Hg (95% CI, -12.8 to -1.4; P = .02).","[{'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Lopes', 'Affiliation': 'Institute of Biomedicine (iBiMED), School of Health Sciences, University of Aveiro, Aveiro, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Mesquita-Bastos', 'Affiliation': 'Institute of Biomedicine (iBiMED), School of Health Sciences, University of Aveiro, Aveiro, Portugal.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Garcia', 'Affiliation': 'Research Center in Sports Sciences, Health and Human Development (CIDESD), University Institute of Maia, Maia, Portugal.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Bertoquini', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Faculty of Medicine, University of Porto, Porto, Portugal.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Ribau', 'Affiliation': 'Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Teixeira', 'Affiliation': 'Institute of Biomedicine (iBiMED), School of Health Sciences, University of Aveiro, Aveiro, Portugal.'}, {'ForeName': 'Ilda P', 'Initials': 'IP', 'LastName': 'Ribeiro', 'Affiliation': 'University of Coimbra, Cytogenetics and Genomics Laboratory, Institute of Cellular and Molecular Biology, Coimbra, Portugal.'}, {'ForeName': 'Joana B', 'Initials': 'JB', 'LastName': 'Melo', 'Affiliation': 'University of Coimbra, Cytogenetics and Genomics Laboratory, Institute of Cellular and Molecular Biology, Coimbra, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Porto, Portugal.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Figueiredo', 'Affiliation': 'Center for Health Technology and Services Research (CINTESIS.UA), School of Health Sciences, University of Aveiro, Aveiro, Portugal.'}, {'ForeName': 'Guilherme V', 'Initials': 'GV', 'LastName': 'Guimarães', 'Affiliation': 'Heart Institute, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Pescatello', 'Affiliation': 'Department of Kinesiology, University of Connecticut, Storrs.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Polonia', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Faculty of Medicine, University of Porto, Porto, Portugal.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Alves', 'Affiliation': 'Research Center in Sports Sciences, Health and Human Development (CIDESD), University Institute of Maia, Maia, Portugal.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': 'Institute of Biomedicine (iBiMED), School of Health Sciences, University of Aveiro, Aveiro, Portugal.'}]",JAMA cardiology,['10.1001/jamacardio.2021.2735']
1029,34346027,"Comparison of Two Ultrasound-guided Plane Blocks for Pain and Postoperative Opioid Requirement in Lumbar Spine Fusion Surgery: A Prospective, Randomized, and Controlled Clinical Trial.","INTRODUCTION


The erector spinae plane (ESP) block and thoracolumbar interfascial plane (TLIP) block were two novel plane blocks. The purpose of this study was to investigate TLIP block and ESP block on the effect of analgesic and opioid consumption in lumbar spine fusion surgery in the perioperative period.
METHODS


Three hundred and four patients who suffered lumbar spine fusion were included and randomly divided into three groups: a control group (n = 102), an ESP block group (n = 100), and a TLIP block group (n = 102). We recorded the numerical rating scale (NRS) pain at movement and static during the postoperative 48 h, opioid consumption, additional analgesic requirement, frequency of patient-controlled analgesia (PCA) compressions, Bruggemann Comfort Scale (BCS) score, side effects, duration of hospital stay, and the life quality score (LQS) after operation at 6 months.
RESULTS


The patients in the ESP block group have better analgesia during 12-48 h postoperative time at static state, a lower frequency of PCA compressions at 24-48 h after surgery, and the opioid consumption in the PCA (sufentanil) were less than those in the TLIP block group (P < 0.05). However, the BCS and LQS scores were no different between the two plane block groups after surgery at 6 months. There was no difference in hospital stay and the incidence of side effect among the three groups.
CONCLUSIONS


Our results found that patients who suffered ESP block have better analgesic effects and less pain scores in static states and less frequency of PCA compression and opioid analgesic consumption compared with those that suffered TLIP block.
TRIAL REGISTRATION


ChiCTR1800019639.",2021,"There was no difference in hospital stay and the incidence of side effect among the three groups.
","['Lumbar Spine Fusion Surgery', 'Three hundred and four patients who suffered lumbar spine fusion']","['Two Ultrasound-guided Plane Blocks', 'TLIP block group', 'TLIP block and ESP block', 'ESP block']","['opioid consumption', 'numerical rating scale (NRS) pain at movement and static during the postoperative 48\xa0h, opioid consumption, additional analgesic requirement, frequency of patient-controlled analgesia (PCA) compressions, Bruggemann Comfort Scale (BCS) score, side effects, duration of hospital stay, and the life quality score (LQS', 'frequency of PCA compressions', 'hospital stay and the incidence of side effect', 'analgesia', 'BCS and LQS scores', 'frequency of PCA compression and opioid analgesic consumption', 'pain scores']","[{'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",304.0,0.0739006,"There was no difference in hospital stay and the incidence of side effect among the three groups.
","[{'ForeName': 'Lizhen', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Lianjie', 'Initials': 'L', 'LastName': 'Dou', 'Affiliation': 'Department of Maternal, Child and Adolescent Health, School of Public Health, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China. hbchenke@163.com.'}, {'ForeName': 'Yuesheng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Yuanhai', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China. liyuanhai-1@163.com.'}]",Pain and therapy,['10.1007/s40122-021-00295-4']
1030,34350732,Meta-analysis of Pharmacokinetic/Pharmacodynamic Results of 3 Phase 1 Studies with Biosimilar Pegfilgrastim.,"A meta-analysis using data from 3 phase 1 studies evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of Sandoz biosimilar versus US- and EU-reference pegfilgrastim. The studies included a single-dose, double-blind, 3-arm, parallel-group study (study 1); a single-dose, double-blind, 2-way crossover study (study 2); and a single-dose, double-blind, 3-way, 6-sequence crossover study (study 3). Healthy male and female subjects were randomized to receive the proposed biosimilar (all studies), US-reference biologic (studies 1 and 3), or EU-reference biologic (studies 1, 2, and 3). For PK parameters (area under the serum concentration-time curve from time of dosing and extrapolated to infinity, area under the serum concentration-time curve from the time of dosing to the last measurable concentration, and maximum observed serum concentration) and PD parameters (absolute neutrophil count area under the effect curve from the time of dosing to the last measurable concentration and maximum measured absolute neutrophil count) geometric mean ratios and 90% confidence intervals (CIs) for treatment comparisons were calculated using the meta-analysis approach with a fixed-effects model. PK/PD biosimilarity was concluded if the 90%CIs were within the equivalence margins of 0.80 to 1.25. The 90%CIs for the geometric mean ratios for the PK/PD parameters were all within the equivalence margins. Safety and tolerability were similar between the proposed biosimilar and the US- and EU-reference pegfilgrastim in healthy subjects. This meta-analysis of 3 phase 1 studies supports PK/PD similarity of Sandoz biosimilar pegfilgrastim to US- and EU-reference pegfilgrastim. No clinically meaningful differences in safety or tolerability were observed.",2021,Safety and tolerability were similar between the proposed biosimilar and the US- and EU-reference pegfilgrastim in healthy subjects.,"['Healthy male and female subjects', 'healthy subjects']","['Biosimilar Pegfilgrastim', 'Sandoz biosimilar versus US- and EU-reference pegfilgrastim']","['Safety and tolerability', 'pharmacokinetics (PK) and pharmacodynamics (PD', 'absolute neutrophil count) geometric mean ratios', 'safety or tolerability']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.121016,Safety and tolerability were similar between the proposed biosimilar and the US- and EU-reference pegfilgrastim in healthy subjects.,"[{'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Gattu', 'Affiliation': 'Hexal AG, Holzkirchen, Germany.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Novartis Inc., Princeton, New Jersey, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellon', 'Affiliation': 'Hexal AG, Holzkirchen, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Schelcher', 'Affiliation': 'Hexal AG, Holzkirchen, Germany.'}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Nakov', 'Affiliation': 'Hexal AG, Holzkirchen, Germany.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Arani', 'Affiliation': 'Novartis Inc., Princeton, New Jersey, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1005']
1031,34348347,The Effects of 8-Week Combined Exercise Training on Inflammatory Markers in Women with Multiple Sclerosis.,"PURPOSE


The present study was designed to investigate the effects of 8-week combined endurance, resistance, and balance exercise training on IL-6, CRP, and IL-10 concentrations in women with multiple sclerosis.
METHODS


Thirty participants with multiple sclerosis (Expanded Disability Status Scale ≤6) were randomized into either an exercise and control groups. The exercise group performed 8-weeks of endurance, resistance, and balance exercise training. Serum concentrations of IL-6, CRP, and IL-10 were measured before and after the 8-week intervention. Moreover, anthropometric measures were determined at the onset of and after the intervention. For within- and between groups comparisons of all variables, t test (independent and dependent) was used (p < 0.05).
RESULTS


The results revealed that IL-6 and CRP levels significantly decreased after exercise training (from 6.8 ± 1.52 to 3.2 ± 0.96, p < 0.001 and from 2.76 ± 0.98 to 1.55 ± 0.44, p = <0.001; respectively). Also, exercise training significantly increased IL-10 in the exercise group (from 16.4 ± 2.74 to 23.2 ± 2.11, p < 0.001). There was a significant difference between the 2 groups in all markers in the after 8-week exercise (p < 0.05).
CONCLUSIONS


One of the characteristics of MS disease is inflammation. Exercise training through physiological mechanisms and without aggravating the inflammatory pathology can be effective in functional and symptom reduction of patients with MS. In confirmation of this, the present study showed that 8 weeks of combined exercise training decreased pro-inflammatory markers (IL-6 and CRP) and increased anti-inflammatory cytokine (IL-10). Our findings suggested that an exercise training program can be an effective strategy for managing the immune system of women with MS at least by its significant effect on inflammatory markers.",2020,,['women with multiple sclerosis'],['combined exercise training'],['inflammatory markers'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0117123,,"[{'ForeName': 'Fahime', 'Initials': 'F', 'LastName': 'Tadayon Zadeh', 'Affiliation': 'Department of Exercise Physiology, Central Tehran Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Amini', 'Affiliation': 'Department of Physical Education & Sport Sciences, Tolou-e-Mehr Non-profit Institute of Higher Education, Qom, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Habibi', 'Affiliation': 'Physical Education Faculty, Khorasgan Branch, Islamic Azad University, Isfahan, Iran.'}, {'ForeName': 'Valiallah', 'Initials': 'V', 'LastName': 'Shahedi', 'Affiliation': 'Department of Physical Education and Sport Sciences, Parand Branch, Islamic Azad University, Parand, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Isanejad', 'Affiliation': 'Department of Physical Education & Sport Sciences, Faculty of Humanities, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Akbarpour', 'Affiliation': 'Department of Physical Education, Faculty of Literature and Humanities, University of Qom, Qom, Iran.'}]",Neuro-degenerative diseases,['10.1159/000518580']
1032,34351590,Oliceridine Exhibits Improved Tolerability Compared to Morphine at Equianalgesic Conditions: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials.,"INTRODUCTION


In the management of postoperative acute moderate-to-severe pain, opioids remain an important component. However, conventional opioids have a narrow therapeutic index and are associated with dose-limiting opioid-related adverse events (ORAEs) that can result in worse patient outcomes. Oliceridine, a new intravenous µ-opioid receptor agonist, is shown in nonclinical studies to be biased for G protein signaling (achieving analgesia) with limited recruitment of β-arrestin (associated with ORAEs). In two phase 3 randomized controlled studies of patients with moderate-to-severe acute pain following hard or soft tissue surgery, in which analgesia was measured using Sum of Pain Intensity Differences (SPID) from baseline over 48 and 24 h (SPID-48 and -24 respectively, oliceridine at demand doses of 0.1, 0.35, or 0.5 mg was highly effective compared to placebo, with a favorable safety profile compared to morphine. This exploratory analysis was conducted to determine whether the safety benefits seen with oliceridine persisted when adjusted for equal levels of analgesia compared to morphine.
METHODS


Presence of at least one treatment-emergent ORAE (based on Medical Dictionary for Regulatory Activities [MedDRA]-coded events: hypoxemia, nausea, vomiting, sedation, pruritus, or dizziness) was used as the composite safety endpoint. A logistic regression model was utilized to compare oliceridine (pooled regimens) versus morphine, after controlling for analgesia (using SPID-48 or SPID-24 with pre-rescue scores carried forward 6 h). This analysis excluded patients receiving placebo and was repeated for each study and for pooled data.
RESULTS


At a given level of SPID-48 or SPID-24, patients receiving oliceridine were less likely to experience the composite safety endpoint. Although not statistically significant at the 0.05 level in the soft tissue model, the odds ratio (OR) showed a consistent numerical trend for oliceridine, being approximately half that observed with morphine in both the hard (OR 0.499; 95% confidence interval [CI] 0.255, 0.976; p = 0.042) and soft (OR 0.542; 95% CI 0.250, 1.175; p = 0.121) tissue studies. Results from the pooled data were consistent with those observed in the individual studies (OR 0.507; 95% CI 0.304, 0.844; p = 0.009).
CONCLUSION


Findings from this exploratory analysis suggest that at comparable levels of analgesia, patients receiving oliceridine were less likely to experience the composite safety endpoint consisting of ORAEs compared to patients treated with morphine. Oliceridine Exhibits Improved Tolerability Compared to Morphine at Equianalgesic Conditions: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials- A Video (MP4 99188 kb).",2021,"At a given level of SPID-48 or SPID-24, patients receiving oliceridine were less likely to experience the composite safety endpoint.","['Presence of at least one treatment-emergent ORAE (based on Medical Dictionary for Regulatory Activities', 'patients with moderate-to-severe acute pain following hard or']","['oliceridine', 'Morphine', 'soft tissue surgery', 'Placebo', 'Oliceridine', 'placebo', 'morphine']","['MedDRA]-coded events: hypoxemia, nausea, vomiting, sedation, pruritus, or dizziness', 'Tolerability', 'Sum of Pain Intensity Differences (SPID']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012113', 'cui_str': 'Dictionary, Medical'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.136989,"At a given level of SPID-48 or SPID-24, patients receiving oliceridine were less likely to experience the composite safety endpoint.","[{'ForeName': 'Gregory B', 'Initials': 'GB', 'LastName': 'Hammer', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, 94305-5640, USA. ham@stanford.edu.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Section on Critical Care Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Michalsky', 'Affiliation': 'Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wase', 'Affiliation': 'Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'Little', 'Affiliation': 'Department of Statistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': ""Department of Outcomes Research, Cleveland Clinic's Anesthesiology Institute, Fairview Hospital, Cleveland, OH, USA.""}]",Pain and therapy,['10.1007/s40122-021-00299-0']
1033,34351363,Long-term effect of a 24-week multicomponent intervention on physical performance and frailty in community-dwelling older adults.,"INTRODUCTION


Multicomponent interventions improve physical function and frailty in older adults, but their long-term benefit remains uncertain.
METHODS


This prospective non-randomised study was conducted in 383 older Koreans (mean age, 76.8 years; female 72.3%) who were living alone or receiving medical aid. Of these, 187 individuals chose to receive a 24-week intervention that consisted of group exercise, nutritional supplements, depression management, deprescribing and home hazard reduction. The remaining 196 individuals received usual care. We compared the short physical performance battery (SPPB) score (0-12 points), frailty phenotype scale (0-5 points) and deficit-accumulation frailty index (0-1) at baseline, 6, 18 and 30 months.
RESULTS


After 1:1 propensity score matching (n = 117 per group), the mean SPPB scores for the intervention and comparison groups were 7.6 versus 7.6 at baseline, 10.7 versus 7.1 at 6 months (mean difference, 3.5; 95% confidence interval [CI], 2.8-4.2), 9.1 versus 7.8 at 18 months (1.3; 95% CI, 0.6-2.0) and 8.6 versus 7.5 at 30 months (1.1; 95% CI, 0.4-1.8). The intervention group had lower frailty phenotype scale (1.1 versus 1.8; difference, -0.7; 95% CI -1.0 to -0.3) and frailty index (0.22 versus 0.27; difference, -0.04; -0.06 to -0.02) at 6 months, but similar scores at 18 and 30 months. The 30-month mean institutionalisation-free survival time was 28.5 months in the intervention group versus 23.3 months in the comparison group (difference, 5.2 months; 95% CI, 3.1-7.4).
CONCLUSIONS


The 24-week multicomponent intervention showed sustained improvement in physical function, temporary reduction in frailty and longer institutionalisation-free survival over 30 months.",2021,"The 24-week multicomponent intervention showed sustained improvement in physical function, temporary reduction in frailty and longer institutionalisation-free survival over 30 months.","['383 older Koreans (mean age, 76.8\xa0years; female 72.3%) who were living alone or receiving medical aid', '187 individuals', 'community-dwelling older adults', 'older adults']","['Multicomponent interventions', 'multicomponent intervention', 'usual care']","['30-month mean institutionalisation-free survival time', 'physical function, temporary reduction in frailty and longer institutionalisation-free survival', 'physical performance and frailty', 'frailty index', 'mean SPPB scores', 'lower frailty phenotype scale', 'short physical performance battery (SPPB) score (0-12 points), frailty phenotype scale (0-5 points) and deficit-accumulation frailty index']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439044', 'cui_str': 'Lives alone'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",383.0,0.120334,"The 24-week multicomponent intervention showed sustained improvement in physical function, temporary reduction in frailty and longer institutionalisation-free survival over 30 months.","[{'ForeName': 'Gahee', 'Initials': 'G', 'LastName': 'Oh', 'Affiliation': 'Marcus Institute for Aging Research, Hebrew Senior Life, Boston, MA, USA.'}, {'ForeName': 'Heayon', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chan Mi', 'Initials': 'CM', 'LastName': 'Park', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee-Won', 'Initials': 'HW', 'LastName': 'Jung', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Il-Young', 'Initials': 'IY', 'LastName': 'Jang', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Guralnik', 'Affiliation': 'Division of Gerontology, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Marcus Institute for Aging Research, Hebrew Senior Life, Boston, MA, USA.'}]",Age and ageing,['10.1093/ageing/afab149']
1034,34355354,Early Data on Long-term Impact of Inotersen on Quality-of-Life in Patients with Hereditary Transthyretin Amyloidosis Polyneuropathy: Open-Label Extension of NEURO-TTR.,"INTRODUCTION


Patients with hereditary transthyretin amyloidosis associated with polyneuropathy (ATTRv-PN) experience deterioration in health-related quality of life (HRQOL) as the disease progresses. Findings from the randomized placebo-controlled phase III NEURO-TTR study showed treatment benefit of inotersen, an antisense oligonucleotide, for preserving or improving HRQOL after 65 weeks of treatment. The current analysis examines longitudinal trends in specific aspects of HRQOL, including polyneuropathy symptoms, daily activities, and physical, role, and social functioning in patients with ATTRv-PN receiving long-term treatment in a follow-up open-label extension (OLE) study.
METHODS


One-hundred thirty-five patients with ATTRv-PN were enrolled in an ongoing 5-year OLE study following completion of NEURO-TTR. Eighty-five patients received continuous weekly treatment with inotersen in both studies (inotersen-inotersen group), while 50 patients switched from placebo to inotersen at OLE study baseline (placebo-inotersen group). Descriptive analyses of changes in domain scores and item responses through week 104 of the OLE study were conducted for measures of neuropathy-related and generic HRQOL: Norfolk QOL-Diabetic Neuropathy (DN) questionnaire and SF-36v2® Health Survey (SF-36v2), respectively.
RESULTS


For both inotersen-inotersen and placebo-inotersen groups, all Norfolk QOL-DN and most SF-36v2 domain scores remained stable from OLE baseline through week 104. Differences in HRQOL between the two groups at OLE baseline were sustained through week 104. Analysis of item responses from NEURO-TTR baseline to OLE study week 104 (170 weeks) for the inotersen-inotersen group found no notable increases in the proportion of patients reporting substantial impairments across a wide variety of symptoms, daily activities, and functioning.
CONCLUSION


Long-term treatment with inotersen preserved HRQOL for patients with ATTRv-PN for periods of up to 3 years. The gap in HRQOL between those who had previously received inotersen or placebo in NEURO-TTR did not close by week 104 of the OLE phase, indicating the importance of early treatment for maintaining HRQOL in these patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifiers NCT01737398 for NEURO-TTR study; NCT02175004 for OLE study INFOGRAPHIC.",2021,Long-term treatment with inotersen preserved HRQOL for patients with ATTRv-PN for periods of up to 3 years.,"['patients with ATTRv-PN receiving long-term treatment in a follow-up open-label extension (OLE) study', 'One-hundred thirty-five patients with ATTRv-PN were enrolled in an ongoing 5-year OLE study following completion of NEURO-TTR', 'Patients with Hereditary Transthyretin Amyloidosis Polyneuropathy']","['placebo', 'placebo to inotersen at OLE study baseline (placebo-inotersen group']","['polyneuropathy symptoms, daily activities, and physical, role, and social functioning', 'HRQOL', 'proportion of patients reporting substantial impairments across a wide variety of symptoms, daily activities, and functioning', 'Quality-of-Life', 'neuropathy-related and generic HRQOL: Norfolk QOL-Diabetic Neuropathy (DN) questionnaire and SF-36v2® Health Survey (SF-36v2', 'Norfolk QOL-DN and most SF-36v2 domain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C2751492', 'cui_str': 'Hereditary Amyloidosis, Transthyretin-Related'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4731850', 'cui_str': 'inotersen'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0454866', 'cui_str': 'Norfolk'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",135.0,0.146943,Long-term treatment with inotersen preserved HRQOL for patients with ATTRv-PN for periods of up to 3 years.,"[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Yarlas', 'Affiliation': 'QualityMetric, 1301 Atwood Avenue, Suite 316E, Johnston, RI, 02919, USA. ayarlas@qualitymetric.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lovley', 'Affiliation': 'QualityMetric, 1301 Atwood Avenue, Suite 316E, Johnston, RI, 02919, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'McCausland', 'Affiliation': 'QualityMetric, 1301 Atwood Avenue, Suite 316E, Johnston, RI, 02919, USA.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Ionis Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Vera-Llonch', 'Affiliation': 'Ionis Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Conceição', 'Affiliation': 'Centro Hospitalar Universitário Lisboa Norte, Hospital de Santa Maria and Faculdade de Medicina, Lisbon, Portugal.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Khella', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Obici', 'Affiliation': 'Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Waddington-Cruz', 'Affiliation': 'Federal University of Rio de Janeiro, National Amyloidosis Referral Center, CEPARM, Rio de Janeiro, Brazil.'}]",Neurology and therapy,['10.1007/s40120-021-00268-x']
1035,34355337,"The Effect of Antrum Size on Weight Loss, Glucagon-Like Peptide-1 (GLP-1) Levels, and Glycemic Control Following Laparoscopic Sleeve Gastrectomy in Adolescents with Obesity and Type 2 Diabetes.","PURPOSE


The aim of this study was to compare the effect of antral resection versus antral preservation sleeve gastrectomy on the post-operative GLP-1, glycemic control, and weight loss in adolescents suffering from severe obesity and type 2 diabetes (T2D).
MATERIALS AND METHODS


This study included 36 adolescents. Patients were randomly divided into 2 groups: group (A) and group (B). Each group included 18 patients who underwent LSG, starting transection at 2 cm or 5 cm from the pyloric ring in group (A) and group (B), respectively. They were followed up at 1, 3, 6, 12, and 24 months post-operatively. The outcomes were the post-operative GLP-1 response, glycemic control, weight loss, and safety.
RESULTS


The improvements in the body mass index and the percentage of excess weight loss (%EWL) were statistically significant within each group. The mean GLP-1 levels showed significant increase at the 1, 3, and 6 months but not in the 12 and 24 months in all the studied samples within each group. The mean HbA1c levels and post-prandial serum C-peptide significantly improved within each group (P < 0.05). No statistical differences in the weight loss, %EWL, GLP-1, HbA1c, C-peptide changes, and complication rates were observed between both groups. Diabetic remission was significantly higher (88.9%) in group (A).
CONCLUSIONS


LSG resulted in generalized significant GLP-1 initial response that decreased over time. The reduced antrum size did not influence the GLP-1 response, glycemic control, or insulin resistance, but resulted in significantly better T2D remission. Since the study examines a small number of patients, further studies are needed.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04388059.",2021,"No statistical differences in the weight loss, %EWL, GLP-1, HbA1c, C-peptide changes, and complication rates were observed between both groups.","['36 adolescents', 'Adolescents with Obesity and Type 2 Diabetes', '18 patients who underwent', 'adolescents suffering from severe obesity and type 2 diabetes (T2D']","['LSG, starting transection at 2 cm or 5 cm from the pyloric ring', 'antral resection versus antral preservation sleeve gastrectomy', 'LSG', 'Laparoscopic Sleeve Gastrectomy']","['Diabetic remission', 'mean GLP-1 levels', 'generalized significant GLP-1 initial response', 'weight loss, %EWL, GLP-1, HbA1c, C-peptide changes, and complication rates', 'GLP-1 response, glycemic control, or insulin resistance', 'T2D remission', 'body mass index and the percentage of excess weight loss', 'post-operative GLP-1 response, glycemic control, weight loss, and safety', 'Weight Loss, Glucagon-Like Peptide-1 (GLP-1) Levels, and Glycemic Control', 'mean HbA1c levels and post-prandial serum C-peptide']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}]","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0152060', 'cui_str': 'Transection'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",36.0,0.0144598,"No statistical differences in the weight loss, %EWL, GLP-1, HbA1c, C-peptide changes, and complication rates were observed between both groups.","[{'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Shehata', 'Affiliation': 'Department of General Surgery, Pediatric Surgery Unit, Faculty of Medicine, Tanta University, El-Geish Street, Tanta, 31257, Egypt. Mohamedshehata81@hotmail.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elhaddad', 'Affiliation': 'Department of General Surgery, Pediatric Surgery Unit, Faculty of Medicine, Tanta University, El-Geish Street, Tanta, 31257, Egypt.'}, {'ForeName': 'Ashraf A', 'Initials': 'AA', 'LastName': 'El-Attar', 'Affiliation': 'Department of General Surgery, Pediatric Surgery Unit, Faculty of Medicine, Tanta University, El-Geish Street, Tanta, 31257, Egypt.'}, {'ForeName': 'Sherif M', 'Initials': 'SM', 'LastName': 'Shehata', 'Affiliation': 'Department of General Surgery, Pediatric Surgery Unit, Faculty of Medicine, Tanta University, El-Geish Street, Tanta, 31257, Egypt.'}]",Obesity surgery,['10.1007/s11695-021-05590-9']
1036,34357673,Comparison of 6-month vascular healing response after bioresorbable polymer versus durable polymer drug-eluting stent implantation in patients with acute coronary syndromes: A randomized serial optical coherence tomography study.,"OBJECTIVES


This study was conducted to use optical coherence tomography (OCT) to compare vascular healing between bioresorbable polymer (BP) and durable polymer (DP) everolimus-eluting stents (EES) in patients with acute coronary syndromes (ACS).
BACKGROUND


Whether BP-EES induce better vascular healing compared to contemporary DP-EES remains controversial, especially for ACS.
METHODS


In this prospective, randomized, non-inferiority trial, we used OCT to compare 6-month vascular healing in patients with ACS randomized to BP versus DP-EES: percent strut coverage (primary endpoint, non-inferiority margin of 2.0%) and neointimal thickness and percent neointimal hyperplasia (NIH) volume. As an exploratory analysis, morphological factors related to the endpoints and the effect of underlying lipidic plaque on stent healing were evaluated.
RESULTS


A total of 104 patients with ACS were randomly assigned to BP-EES (n = 52) versus DP-EES (n = 52). Of these, 86 patients (40 BP-EES and 46 DP-EES) were included in the final OCT analyses. Six-month percent strut coverage of BP-EES (83.6 ± 11.4%) was not non-inferior compared to those of DP-EES (81.6 ± 13.9%), difference 2.0% (lower 95% confidence interval-2.6%), p non-inferiority   = 0.07. There were no differences in neointimal thickness 70.0 ± 33.9 μm versus 67.2 ± 33.9 μm, p = 0.71; and percent NIH volume 7.5 ± 4.7% versus 7.3 ± 5.3%, p = 0.85. By multivariable linear regression analysis, stent type was not associated with percent strut coverage or percent NIH volume; however, percent baseline embedded struts or stent expansion was positively associated with percent NIH volume. Greater NIH volume was observed in lipidic compared with non-lipidic segments (8.7 ± 5.6% vs. 6.1 ± 5.2%, p = 0.005).
CONCLUSIONS


Six-month strut coverage of BP-EES was not non-inferior compared to those of DP-EES in ACS patients. Good stent apposition and expansion were independently associated with better vascular healing.",2021,"Greater NIH volume was observed in lipidic compared with non-lipidic segments (8.7 ± 5.6% vs. 6.1 ± 5.2%, p = 0.005).
","['patients with acute coronary syndromes', '86 patients (40 BP-EES and 46 DP-EES', 'patients with ACS randomized to', 'patients with acute coronary syndromes (ACS', '104 patients with ACS']","['bioresorbable polymer versus durable polymer drug-eluting stent implantation', 'optical coherence tomography (OCT', 'BP versus DP-EES', 'OCT', 'DP-EES', 'BP-EES', 'bioresorbable polymer (BP) and durable polymer (DP) everolimus-eluting stents (EES']","['Greater NIH volume', 'neointimal thickness and percent neointimal hyperplasia (NIH) volume', 'vascular healing response', 'neointimal thickness', 'vascular healing', 'strut coverage of BP-EES']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C4049446', 'cui_str': 'Neointimal hyperplasia'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]",104.0,0.0546897,"Greater NIH volume was observed in lipidic compared with non-lipidic segments (8.7 ± 5.6% vs. 6.1 ± 5.2%, p = 0.005).
","[{'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Noguchi', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomotaka', 'Initials': 'T', 'LastName': 'Dohi', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Okazaki', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Matsumura', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirohisa', 'Initials': 'H', 'LastName': 'Endo', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Iwao', 'Initials': 'I', 'LastName': 'Okai', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Doi', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kikuo', 'Initials': 'K', 'LastName': 'Isoda', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Usui', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Tatsuhiro', 'Initials': 'T', 'LastName': 'Fujimura', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Fumiyasu', 'Initials': 'F', 'LastName': 'Seike', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Daida', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Minamino', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29892']
1037,34357593,Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial.,"BACKGROUND


Breast cancer survivors often have persisting headache. In a secondary analysis of the Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) clinical trial (ClinicalTrials.gov identifier NCT02165839), the authors examined the effects of BBT-CI on headache outcomes in patients with breast cancer.
METHODS


Patients with breast cancer who were receiving chemotherapy were randomly assigned to receive either the BBT-CI intervention or the Healthy EAting Education Learning for healthy sleep (HEAL) control intervention, and both were delivered over 6 weeks by trained staff. Headache outcomes and heart rate variability (HRV) were measured at baseline, 6 weeks, 6 months, and 12 months. Mixed-effects models were used to examine longitudinal headache outcomes in the groups according to the intention to treat. Principal component analysis and agglomerative hierarchical clustering were conducted to reduce 16 variables for data-driven phenotyping.
RESULTS


Patients in the BBT-CI arm (n = 73) exhibited a significant reduction in headache burden over time (P = .02; effect size [Cohen d] = 0.43), whereas the reduction was not significant among those in the HEAL arm (n = 66). The first principal component was positively loaded by headache, sleep, fatigue, and nausea/vomiting and was negatively loaded by cognitive, physical, and emotional functioning. Agglomerative hierarchical clustering revealed 3 natural clusters. Cluster I (n = 58) featured the highest burden of headache, insomnia, and nausea/vomiting; cluster II (n = 50) featured the lowest HRV despite a low burden of headache and insomnia; and cluster III (n = 31) showed an inverse relation between HRV and headache-insomnia, signifying autonomic dysfunction.
CONCLUSIONS


BBT-CI is efficacious in reducing headache burden in breast cancer survivors. Patient phenotyping demonstrates a headache type featuring sleep disturbance, nausea/vomiting, and low physical functioning-revealing similarities to migraine.
LAY SUMMARY


Breast cancer survivors often have persisting headache symptoms. In patients with cancer, treatment of chronic headache disorders using daily medications may be challenging because of drug interactions with chemotherapy and other cancer therapies as well as patients' reluctance to add more drugs to their medicine list. Headache and sleep disorders are closely related to each other. This study demonstrates that a sleep behavioral therapy reduced headache burden in breast cancer survivors. In addition, the majority of headache sufferers had a headache type with similarities to migraine-featuring sleep disturbance, nausea/vomiting, and low physical functioning.",2021,"RESULTS


Patients in the BBT-CI arm (n = 73) exhibited a significant reduction in headache burden over time (P = .02; effect size [Cohen d] = 0.43), whereas the reduction was not significant among those in the HEAL arm (n = 66).","['Patients with breast cancer who were receiving chemotherapy', 'Breast cancer survivors', 'patients with breast cancer', 'breast cancer survivors']","['sleep behavioral therapy', 'BBT-CI', 'BBT-CI intervention or the Healthy EAting Education Learning for healthy sleep (HEAL) control intervention, and both were delivered over 6 weeks by trained staff', 'sleep behavioral intervention']","['headache, sleep, fatigue, and nausea/vomiting and was negatively loaded by cognitive, physical, and emotional functioning', 'Headache outcomes', 'headache burden', 'headache type featuring sleep disturbance, nausea/vomiting', 'Headache and sleep disorders', 'Headache outcomes and heart rate variability (HRV', 'headache outcomes', 'nausea/vomiting, and low physical functioning', 'highest burden of headache, insomnia, and nausea/vomiting', 'headache burden over time', 'HRV and headache-insomnia, signifying autonomic dysfunction', 'longitudinal headache outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013363', 'cui_str': 'Dysautonomia'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}]",73.0,0.23868,"RESULTS


Patients in the BBT-CI arm (n = 73) exhibited a significant reduction in headache burden over time (P = .02; effect size [Cohen d] = 0.43), whereas the reduction was not significant among those in the HEAL arm (n = 66).","[{'ForeName': 'Yohannes W', 'Initials': 'YW', 'LastName': 'Woldeamanuel', 'Affiliation': 'Division of Headache Medicine, Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Blayney', 'Affiliation': 'Stanford Cancer Institute, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Fisher', 'Affiliation': 'Stanford Cancer Survivorship Research, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Benedict', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Oakley-Girvan', 'Affiliation': 'The Data and Technology Proving Ground, Public Health Institute, Oakland, California.'}, {'ForeName': 'Shelli R', 'Initials': 'SR', 'LastName': 'Kesler', 'Affiliation': 'Cancer Neuroscience Laboratory, School of Nursing, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Oxana', 'Initials': 'O', 'LastName': 'Palesh', 'Affiliation': 'Stanford Cancer Institute, Stanford University School of Medicine, Palo Alto, California.'}]",Cancer,['10.1002/cncr.33844']
1038,34363307,"Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain.","BACKGROUND


Spinal cord stimulation (SCS) is a well-established treatment for chronic intractable pain of the trunk and/or limbs; however, low back pain (LBP) is difficult to treat using traditional SCS. Differential Target Multiplexed spinal cord stimulation (DTM SCS) is an advanced approach inspired from animal studies demonstrating improved pain-related behavior and pain-relevant biological processes.
OBJECTIVE


The purpose of this study was to compare the effectiveness of DTM SCS and traditional SCS in treating chronic LBP and leg pain (LP).
METHODS


This prospective, postmarket randomized controlled trial compared DTM SCS to traditional SCS in patients with chronic LBP and LP. Primary end point was LBP responder rate (percentage of subjects with ≥ 50% relief) at 3 months. Noninferiority and superiority were assessed. Other outcomes included mean change in back and leg pain, responder rates, disability, global health, satisfaction, and safety profile throughout the 12-month follow-up.
RESULTS


One hundred twenty-eight subjects were randomized across 12 centers (67 DTM SCS and 61 traditional SCS). Of the 94 patients implanted, 46 subjects in each group completed the 3-month assessment. LBP responder rate of 80.1% with DTM SCS was superior to 51.2% with traditional SCS (p = 0.0010). Mean LBP reduction (5.36 cm) with DTM SCS was greater than reduction (3.37 cm) with traditional SCS (p < 0.0001). These results were sustained at 6 months and 12 months. Safety profiles were similar between treatment groups.
CONCLUSION


Superiority of DTM SCS compared with traditional SCS for chronic LBP was demonstrated. Clinical improvements provided by DTM SCS were sustained over 12 months and are expected to significantly impact the management of chronic LBP.",2021,Mean LBP reduction (5.36 cm) with DTM SCS was greater than reduction (3.37 cm) with traditional SCS (P < 0.0001).,"['Subjects with Chronic Intractable Back Pain and Leg Pain', 'One hundred and twenty-eight subjects were randomized across 12 centers (67 DTM SCS, 61 traditional SCS', '94 patients implanted, 46 subjects in each group completed the 3-month assessment', 'patients with chronic low back and leg pain']","['DTM SCS', 'Differential Target Multiplexed spinal cord stimulation (DTM SCS', 'DTM SCS and traditional SCS', 'Differential Target Multiplexed Spinal Cord Stimulation and Traditional Spinal Cord Stimulation']","['Safety profiles', 'LBP responder rate', 'Mean LBP reduction', 'mean change in back and leg pain, responder rates, disability, global health, satisfaction, and safety profile']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",128.0,0.0723661,Mean LBP reduction (5.36 cm) with DTM SCS was greater than reduction (3.37 cm) with traditional SCS (P < 0.0001).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Center for Interventional Pain and Spine, Exton, Pennsylvania, USA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Cordner', 'Affiliation': 'Florida Pain Management Associates, Sebastian, Florida, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Justiz', 'Affiliation': 'Oklahoma Pain Physicians, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Provenzano', 'Affiliation': 'Pain Diagnostics and Interventional Care, LLC, Sewickly, Pennsylvania, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Merrell', 'Affiliation': 'Coastal Carolina Research Center, Charleston, South Carolina, USA.'}, {'ForeName': 'Binit', 'Initials': 'B', 'LastName': 'Shah', 'Affiliation': 'Carolinas Research Institute, PLLC, Huntersville, North Carolina, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Naranjo', 'Affiliation': 'South Florida Clinical Research, South Miami, Florida, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kim', 'Affiliation': 'Center for Interventional Pain and Spine, Exton, Pennsylvania, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Calodney', 'Affiliation': 'Precision Spine Care, Tyler, Texas, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carlson', 'Affiliation': 'Hawaii Pain and Spine, Kailua, Hawaii, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bundschu', 'Affiliation': 'Coastal Orthopedics, Bradenton, Florida, USA.'}, {'ForeName': 'Mahendra', 'Initials': 'M', 'LastName': 'Sanapati', 'Affiliation': 'Global Scientific Innovations, LLC, Evansville, Illinois, USA.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Mangal', 'Affiliation': 'National Spine and Pain Center, Oxon Hill, Maryland, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Vallejo', 'Affiliation': 'National Spine and Pain Centers, Bloomington, Illinois, USA.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.13066']
1039,34363293,"Modification of oxytocin use through a coaching-based intervention based on the WHO Safe Childbirth Checklist in Uttar Pradesh, India: a secondary analysis of a cluster randomised controlled trial.","OBJECTIVE


To understand the prevalence of intrapartum oxytocin use, assess associated perinatal and maternal outcomes, and evaluate the impact of a WHO Safe Childbirth Checklist intervention on oxytocin use at primary-level facilities in Uttar Pradesh, India.
DESIGN


Secondary analysis of a cluster-randomised controlled trial.
SETTING


Thirty Primary and Community public health facilities in Uttar Pradesh, India from 2014 to 2017.
POPULATION


Women admitted to a study facility for childbirth at baseline, 2, 6 or 12 months after intervention initiation.
METHODS


The BetterBirth intervention aimed to increase adherence to the WHO Safe Childbirth Checklist. We used Rao-Scott Chi-square tests to compare (1) timing of oxytocin use between study arms and (2) perinatal mortality and resuscitation of infants whose mothers received intrapartum oxytocin versus who did not.
MAIN OUTCOME MEASURES


Intrapartum and postpartum oxytocin administration, perinatal mortality, use of neonatal bag and mask.
RESULTS


We observed 5484 deliveries. At baseline, intrapartum oxytocin was administered to 78.2% of women. Two months after intervention initiation, intrapartum oxytocin (I) was administered to 32.1% of women compared with 70.6% in the control (C) (P < 0.01); this difference diminished after the end of the intervention (I = 48.2%, C = 74.7%, P = 0.03). Partograph use remained at <1% at all facilities. Resuscitation was performed on 7.5% of infants whose mother received intrapartum oxytocin versus 2.0% who did not (P < 0.0001).
CONCLUSIONS


In this setting, intrapartum oxytocin use was high despite limited maternal/fetal monitoring or caesarean capability, and was associated with increased neonatal resuscitation. The BetterBirth intervention was successful at decreasing intrapartum oxytocin use. Ongoing support is needed to sustain these practices.
TWEETABLE ABSTRACT


Coaching + WHO Safe Childbirth Checklist reduces intrapartum oxytocin use and need for newborn resuscitation.",2021,"this difference diminished after the intervention's end (I=48.2%, C=74.7%, p=0.03).","[' 30 Primary and Community public health facilities in Uttar Pradesh, India from 2014 to 2017 POPULATION OR SAMPLE', 'use at primary-level facilities in Uttar Pradesh, India']","['oxytocin', 'WHO Safe Childbirth Checklist intervention', 'intrapartum oxytocin', 'intrapartum oxytocin versus not']","['adherence to the WHO Safe Childbirth Checklist', 'perinatal mortality, use of neonatal bag']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0179196', 'cui_str': 'Bag'}]",,0.116393,"this difference diminished after the intervention's end (I=48.2%, C=74.7%, p=0.03).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marx Delaney', 'Affiliation': ""Ariadne Labs at Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kalita', 'Affiliation': 'Population Services International, Guwahati, Assam, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hawrusik', 'Affiliation': ""Ariadne Labs at Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Neal', 'Affiliation': ""Ariadne Labs at Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': ""Ariadne Labs at Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ketchum', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Molina', 'Affiliation': ""Ariadne Labs at Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Community Empowerment Lab, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Community Empowerment Lab, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Kea', 'Initials': 'K', 'LastName': 'Semrau', 'Affiliation': ""Ariadne Labs at Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital, Boston, MA, USA.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16856']
1040,34368947,Multifaceted intervention including Facebook-groups to improve guideline-adherence in ICU: A quasi-experimental interrupted time series study.,"BACKGROUND


The impact of social media, with its speed, reach and accessibility, in interventions aimed to improve adherence to guidelines such as assessment of Pain, Agitation/Sedation and Delirium (PAD) in intensive care is not described. Therefore, the primary objective of this quality improvement study was to evaluate the impact of a multifaceted intervention including audit and feedback of quality indicators (QI) via Facebook-groups, educational events and engagement of opinion leaders on adherence to PAD-guidelines in four ICUs.
METHODS


A quasi-experimental interrupted time series study with eight monthly data points in the two phases Before and Intervention was designed. Proportion of nursing shifts with documented PAD-assessment (PAD-QIs) were retrieved from the electronical medical chart from included adult ICU patient-stays in four participating ICUs. Difference between the two time periods was assessed using generalised mixed model for repeated measures with unstructured covariance matrix, and presented as Beta (B) with 95% confidence interval (CI).
RESULTS


Finally, 1049 ICU patient-stays were analysed; 534 in Before and 515 in Intervention. All three PAD-QIs significantly increased in Intervention by 31% (B = 30.7, 95%CI [25.7 to 35.8]), 26% (B = 25.8, 95%CI [19.4 to 32.2]) and 34% (B = 33.9, 95%CI [28.4 to 39.4]) in pain, agitation/sedation and delirium, respectively.
CONCLUSION


A multifaceted intervention including use of Facebook-groups was associated with improved guideline-adherence in four ICUs, as measured with process PAD-QIs of PAD assessment. Further research on use of social media to improve guideline adherence is warranted, particularly as social distancing impacts clinical education and training and new approaches are needed.",2021,"A multifaceted intervention including use of Facebook-groups was associated with improved guideline-adherence in four ICUs, as measured with process PAD-QIs of PAD assessment.",['Proportion of nursing shifts with documented PAD-assessment (PAD-QIs) were retrieved from the electronical medical chart from included adult ICU patient-stays in four participating ICUs'],[],"['PAD-QIs', 'pain, agitation/sedation and delirium']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",,0.0612266,"A multifaceted intervention including use of Facebook-groups was associated with improved guideline-adherence in four ICUs, as measured with process PAD-QIs of PAD assessment.","[{'ForeName': 'Antonija', 'Initials': 'A', 'LastName': 'Petosic', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Postoperative and Intensive Care, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Milada C', 'Initials': 'MC', 'LastName': 'Småstuen', 'Affiliation': 'Department of Public Health, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Beeckman', 'Affiliation': 'Skin Integrity Research Group (SKINT), Department of Public Health and Primary Care, University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Flaatten', 'Affiliation': 'University of Bergen, Bergen, Norway.'}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Sunde', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Wøien', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Postoperative and Intensive Care, Oslo University Hospital, Oslo, Norway.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13969']
1041,34368944,A comparison of the in vitro effects of three fibrinogen concentrates on clot strength in blood samples from cardiac surgery patients.,"BACKGROUND


Fibrinogen concentrate is used clinically to improve hemostasis in bleeding patients. We investigated and compared the efficacy of three commercially available fibrinogen concentrates to improve clot strength in blood samples from cardiac surgery patients.
OBJECTIVES


Postoperative blood samples were collected from 23 cardiac surgery patients. Samples were each divided into four vials, each supplemented with 1.125 mg of fibrinogen of one of three fibrinogen concentrates (RiaSTAP ®  , Fibryga ®  , FibCLOT ®  ), or placebo. The fibrinogen dose corresponded to 2.5 g per 70 kg of body weight. Clot strength after supplementation was assessed in duplicate with rotational thromboelastometry (ROTEM ®  ) using FIBTEM maximum clot firmness, EXTEM clot formation time, and maximum clot firmness assays.
RESULTS


In vitro fibrinogen concentrate supplementation of the samples resulted in higher plasma fibrinogen concentrations and improved clot strength with all three concentrates. Supplementation with FibCLOT increased FIBTEM maximum clot firmness (+46% [25th-75th percentile 35-55] compared to placebo) significantly more than did supplementation with Fibryga (+26% [21-35]) and RiaSTAP (+29% [22-47], p < .001). FibCLOT supplementation also shortened EXTEM clot formation time and increased EXTEM maximum clot firmness to a greater extent than did the other concentrates (both p < .001).
CONCLUSIONS


At the selected dose, FibCLOT was more effective than Fibryga and RiaSTAP in restoring clot strength in postoperative blood samples from cardiac surgery patients. These results may have implications for the choice of fibrinogen concentrate and dosing.",2021,"FibCLOT supplementation also shortened EXTEM clot formation time and increased EXTEM maximum clot firmness to a greater extent than did the other concentrates (both p<0.001).
","['cardiac surgery patients', '23 cardiac surgery patients', 'bleeding patients']","['RiaSTAP', 'FibCLOT supplementation', 'Fibryga and RiaSTAP', 'fibrinogen concentrates', 'fibrinogen concentrates (RiaSTAP®, Fibryga®, FibCLOT®), or placebo', 'FibCLOT']","['FIBTEM maximum clot firmness', 'Clot strength', 'clot strength', 'plasma fibrinogen concentrations']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C2587183', 'cui_str': 'RiaSTAP'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4529781', 'cui_str': 'Fibryga'}, {'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.102486,"FibCLOT supplementation also shortened EXTEM clot formation time and increased EXTEM maximum clot firmness to a greater extent than did the other concentrates (both p<0.001).
","[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Stolt', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Shams Hakimi', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Sukhi', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jeppsson', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Karlsson', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13967']
1042,33830175,Pathways Through Which Health Literacy Is Linked to Parental Oral Health Behavior in an American Indian Tribe.,"BACKGROUND


Health literacy (HL) is the ""ability to find, understand, evaluate and put information to use to improve decision making and, ultimately, improve health and quality of life."" Parents with limited HL are less likely to follow recommended parental oral health behaviors.
PURPOSE


We tested a theoretical framework designed to clarify mechanisms through which HL may influence parental oral health behavior. The framework proposed that HL: (a) has a direct effect on parental oral health knowledge, beliefs (i.e. self-efficacy; perceived susceptibility, severity, benefits, barriers), and behavior; (b) influences beliefs indirectly through knowledge; and (c) influences behavior indirectly through knowledge and beliefs.
METHODS


We analyzed cross-sectional data from a randomized controlled trial designed to reduce dental decay in American Indian children (N = 521). Parents completed survey questions assessing sociodemographic characteristics, HL, and parental oral health knowledge, beliefs, and behavior. Path analysis was used to test the framework.
RESULTS


HL exerted significant direct effects on knowledge and beliefs but not behavior. HL had significant indirect effects on all beliefs through knowledge. Significant indirect effects of HL on behavior occurred through self-efficacy (estimate: 0.99, 95% CI: 0.42, 1.83, p = .005), perceived barriers (estimate: 0.73, 95% CI: 0.29, 1.43, p = .010), knowledge to self-efficacy (estimate: 0.57, 95% CI: .31, 0.98, p = .001), and knowledge to perceived barriers (estimate: 0.24, 95% CI: 0.09, 0.47, p = .012).
CONCLUSIONS


HL exerted an indirect effect on parental oral health behavior, with knowledge, self-efficacy, and perceived barriers being the primary constructs linking HL to behavior.",2021,"Significant indirect effects of HL on behavior occurred through self-efficacy (estimate: 0.99, 95% CI: 0.42, 1.83, p = .005), perceived barriers (estimate:",['American Indian children (N = 521'],['HL'],"['health and quality of life', 'behavior occurred through self-efficacy', 'parental oral health behavior, with knowledge, self-efficacy', 'knowledge to self-efficacy', 'survey questions assessing sociodemographic characteristics, HL, and parental oral health knowledge, beliefs, and behavior', 'knowledge and beliefs']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",521.0,0.0224564,"Significant indirect effects of HL on behavior occurred through self-efficacy (estimate: 0.99, 95% CI: 0.42, 1.83, p = .005), perceived barriers (estimate:","[{'ForeName': 'Angela G', 'Initials': 'AG', 'LastName': 'Brega', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Johnson', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schmiege', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Wilson', 'Affiliation': 'Department of Pediatric Dentistry, School of Dental Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Luohua', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Medicine, University of California Irvine, Irvine, CA, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Albino', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab006']
1043,34348526,"Metabolic and laboratory effects of a progestin-only pill containing drospirenone 4 mg in comparison to desogestrel 75 µg: a double-blind, double-dummy, prospective, randomised study.","Purpose:  Steroid hormones in hormonal contraceptives influence a variety of metabolic parameters. Mainly, ethinyloestradiol (EE) in combined hormonal contraceptives (CHC) is a potent inducer of hepatic coagulation factors, has an impact on cholesterol and triglyceride levels and glucose tolerance. Progestins in CHC modify the oestrogen effects in different ways, depending on their pharmacologic properties. The metabolic impact of progestin-only contraceptives is generally considered low. Methods:  The influence of novel drospirenone (DRSP)-only pill (4 mg DRSP in 24/4 intake) on a variety of lipid-, carbohydrate- and bone metabolic parameters and on haemostatic variables including clotting factors and D-Dimer level was evaluated in comparison to 0.075 mg desogestrel (DSG) during a multicentric, prospective, double-blind, double-dummy clinical trial with 1190 participants over nine treatment cycles. Results:  For both DRSP and DSG, there was a decrease in cholesterol (total, HDL, and LDL) and triglyceride levels. No relevant influence on glucose, insulin, and c-peptide levels or bone remodelling markers were detected in both treatment groups. Considering the coagulatory parameters, there was no impact on hemostasis. Conclusions:  The results confirm the beneficial properties of the drospirenone-only pill. EudraCT Number:  2011-002396-42.",2021,"No relevant influence on glucose, insulin, and c-peptide levels or bone remodelling markers were detected in both treatment groups.",['1190 participants over nine treatment cycles'],"['ethinyloestradiol (EE) in combined hormonal contraceptives (CHC', 'novel drospirenone (DRSP)-only pill (4\u2009mg DRSP', 'progestin-only contraceptives', 'progestin-only pill containing drospirenone', 'drospirenone', 'desogestrel (DSG', 'DRSP and DSG']","['clotting factors and D-Dimer level', 'cholesterol and triglyceride levels and glucose tolerance', 'hemostasis', 'cholesterol (total, HDL, and LDL) and triglyceride levels', 'glucose, insulin, and c-peptide levels or bone remodelling markers']","[{'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0284559', 'cui_str': 'gusperimus'}]","[{'cui': 'C0005789', 'cui_str': 'Blood clotting factor'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",1190.0,0.133936,"No relevant influence on glucose, insulin, and c-peptide levels or bone remodelling markers were detected in both treatment groups.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': ""Director of the Palacios Institute of Medicine and Women's Health, Madrid, Spain.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, Madrid, Spain.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Ismaning, Germany.'}]",The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception,['10.1080/13625187.2021.1957094']
1044,34347542,Phase I or II Study of Ribociclib in Combination With Topotecan-Temozolomide or Everolimus in Children With Advanced Malignancies: Arms A and B of the AcSé-ESMART Trial.,"PURPOSE


AcSé-ESMART is a proof-of-concept, phase I or II, platform trial, designed to explore targeted agents in a molecularly enriched cancer population. Arms A and B aimed to define the recommended phase II dose and activity of the CDK4/6 inhibitor ribociclib with topotecan and temozolomide (TOTEM) or everolimus, respectively, in children with recurrent or refractory malignancies.
PATIENTS AND METHODS


Ribociclib was administered orally once daily for 16 days after TOTEM for 5 days (arm A) or for 21 days with everolimus orally once daily continuously in a 28-day cycle (arm B). Dose escalation followed the continuous reassessment method, and activity assessment the Ensign design. Arms were enriched on the basis of molecular alterations in the cell cycle or PI3K/AKT/mTOR pathways.
RESULTS


Thirty-two patients were included, 14 in arm A and 18 in arm B, and 31 were treated. Fourteen patients had sarcomas (43.8%), and 13 brain tumors (40.6%). Main toxicities were leukopenia, neutropenia, and lymphopenia. The recommended phase II dose was ribociclib 260 mg/m 2  once a day, temozolomide 100 mg/m 2  once a day, and topotecan 0.5 mg/m 2  once a day (arm A) and ribociclib 175 mg/m 2  once a day and everolimus 2.5 mg/m 2  once a day (arm B). Pharmacokinetic analyses confirmed the drug-drug interaction of ribociclib on everolimus exposure. Two patients (14.3%) had stable disease as best response in arm A, and seven (41.2%) in arm B, including one patient with T-acute lymphoblastic leukemia with significant blast count reduction. Alterations considered for enrichment were present in 25 patients (81%) and in eight of nine patients with stable disease; the leukemia exhibited CDKN2A/B and PTEN deficiency.
CONCLUSION


Ribociclib in combination with TOTEM or everolimus was well-tolerated. The observed activity signals initiated a follow-up study of the ribociclib-everolimus combination in a population enriched with molecular alterations within both pathways.",2021,"Alterations considered for enrichment were present in 25 patients (81%) and in eight of nine patients with stable disease; the leukemia exhibited CDKN2A/B and PTEN deficiency.
","['Thirty-two patients were included, 14 in arm A and 18 in arm B, and 31 were treated', 'children with recurrent or refractory malignancies', 'Fourteen patients had sarcomas (43.8%), and 13 brain tumors (40.6', 'Children With Advanced Malignancies']","['ribociclib 175 mg/m 2  once a day and everolimus', 'temozolomide', 'everolimus', 'Ribociclib in combination with TOTEM or everolimus', 'Ribociclib in Combination With Topotecan-Temozolomide or Everolimus', 'CDK4/6 inhibitor ribociclib with topotecan and temozolomide (TOTEM) or everolimus']","['Main toxicities were leukopenia, neutropenia, and lymphopenia']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}]",32.0,0.019189,"Alterations considered for enrichment were present in 25 patients (81%) and in eight of nine patients with stable disease; the leukemia exhibited CDKN2A/B and PTEN deficiency.
","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Bautista', 'Affiliation': 'Hospital Niño Jesús, Department of Pediatric Oncology, Hematology and Stem Cell Transplantation, Madrid, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Paoletti', 'Affiliation': 'Gustave Roussy Cancer Campus, Biostatistics and Epidemiology Unit, INSERM U1018, CESP, Université Paris-Saclay, UVSQ, Villejuif, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rubino', 'Affiliation': 'Gustave Roussy Cancer Campus, Clinical Research Direction, Villejuif, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Brard', 'Affiliation': 'Gustave Roussy Cancer Campus, Biostatistics and Epidemiology Unit, INSERM U1018, CESP, Université Paris-Saclay, UVSQ, Villejuif, France.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Rezai', 'Affiliation': 'Institut Curie, Radio-Pharmacology Department, Saint Cloud, France.'}, {'ForeName': 'Souad', 'Initials': 'S', 'LastName': 'Nebchi', 'Affiliation': 'Gustave Roussy Cancer Campus, Biostatistics and Epidemiology Unit, INSERM U1018, CESP, Université Paris-Saclay, UVSQ, Villejuif, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Andre', 'Affiliation': 'Department of Pediatric Oncology, Hôpital de la Timone, AP-HM, Marseille, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Aerts', 'Affiliation': 'SIREDO Oncology Center (Care, Innovation and research for children and AYA with cancer), Institut Curie, PSL Research University, Paris, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'De Carli', 'Affiliation': 'Department of Pediatric Oncology, University Hospital, Angers, France.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'van Eijkelenburg', 'Affiliation': 'Princess Maxima Center for Pediatric Oncology, Utrecht, the Netherlands.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Thebaud', 'Affiliation': 'Department of Pediatric Oncology, Centre Hospitalier Universitaire, Nantes, France.'}, {'ForeName': 'Nadege', 'Initials': 'N', 'LastName': 'Corradini', 'Affiliation': 'Pediatric Oncology Department, Institut of Pediatric Hematology and Oncology, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Defachelles', 'Affiliation': 'Department of Pediatric Oncology, Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Ducassou', 'Affiliation': 'Centre Hospitalier Universitaire Pellegrin-Hôpital des Enfants, Bordeaux, France.'}, {'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Morscher', 'Affiliation': 'Gustave Roussy Cancer Campus, Department of Pediatric and Adolescent Oncology, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Vassal', 'Affiliation': 'Gustave Roussy Cancer Campus, Clinical Research Direction, Villejuif, France.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Geoerger', 'Affiliation': 'Gustave Roussy Cancer Campus, Department of Pediatric and Adolescent Oncology, Université Paris-Saclay, Villejuif, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01152']
1045,34163067,Caloric restriction disrupts the microbiota and colonization resistance.,"Diet is a major factor that shapes the gut microbiome 1 , but the consequences of diet-induced changes in the microbiome for host pathophysiology remain poorly understood. We conducted a randomized human intervention study using a very-low-calorie diet (NCT01105143). Although metabolic health was improved, severe calorie restriction led to a decrease in bacterial abundance and restructuring of the gut microbiome. Transplantation of post-diet microbiota to mice decreased their body weight and adiposity relative to mice that received pre-diet microbiota. Weight loss was associated with impaired nutrient absorption and enrichment in Clostridioides difficile, which was consistent with a decrease in bile acids and was sufficient to replicate metabolic phenotypes in mice in a toxin-dependent manner. These results emphasize the importance of diet-microbiome interactions in modulating host energy balance and the need to understand the role of diet in the interplay between pathogenic and beneficial symbionts.",2021,"Although metabolic health was improved, severe calorie restriction led to a decrease in bacterial abundance and restructuring of the gut microbiome.",[],[],"['microbiota and colonization resistance', 'bacterial abundance and restructuring of the gut microbiome', 'body weight and adiposity relative', 'bile acids', 'Weight loss']",[],[],"[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.00728066,"Although metabolic health was improved, severe calorie restriction led to a decrease in bacterial abundance and restructuring of the gut microbiome.","[{'ForeName': 'Reiner Jumpertz', 'Initials': 'RJ', 'LastName': 'von Schwartzenberg', 'Affiliation': 'Charité Universitätsmedizin Berlin, Department of Endocrinology and Metabolic Diseases, Berlin, Germany.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Bisanz', 'Affiliation': 'Department of Microbiology & Immunology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Lyalina', 'Affiliation': 'Gladstone Institutes, San Francisco, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Spanogiannopoulos', 'Affiliation': 'Department of Microbiology & Immunology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Qi Yan', 'Initials': 'QY', 'LastName': 'Ang', 'Affiliation': 'Department of Microbiology & Immunology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Center for Molecular Toxicology and Carcinogenesis, Department of Veterinary and Biomedical Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Dickmann', 'Affiliation': 'Charité Universitätsmedizin Berlin, Department of Endocrinology and Metabolic Diseases, Berlin, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Friedrich', 'Affiliation': 'Charité Universitätsmedizin Berlin, Department of Endocrinology and Metabolic Diseases, Berlin, Germany.'}, {'ForeName': 'Su-Yang', 'Initials': 'SY', 'LastName': 'Liu', 'Affiliation': 'Department of Pathology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Collins', 'Affiliation': 'Center for Molecular Toxicology and Carcinogenesis, Department of Veterinary and Biomedical Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ingebrigtsen', 'Affiliation': 'Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': 'Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jessie A', 'Initials': 'JA', 'LastName': 'Turnbaugh', 'Affiliation': 'Department of Microbiology & Immunology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Patterson', 'Affiliation': 'Center for Molecular Toxicology and Carcinogenesis, Department of Veterinary and Biomedical Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Pollard', 'Affiliation': 'Gladstone Institutes, San Francisco, CA, USA.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Charité Universitätsmedizin Berlin, Department of Endocrinology and Metabolic Diseases, Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Charité Universitätsmedizin Berlin, Department of Endocrinology and Metabolic Diseases, Berlin, Germany. joachim.spranger@charite.de.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Turnbaugh', 'Affiliation': 'Department of Microbiology & Immunology, University of California San Francisco, San Francisco, CA, USA. peter.turnbaugh@ucsf.edu.'}]",Nature,['10.1038/s41586-021-03663-4']
1046,34354179,Evaluation of two highly effective lipid-lowering therapies in subjects with acute myocardial infarction.,"For cardiovascular disease prevention, statins alone or combined with ezetimibe have been recommended to achieve low-density lipoprotein cholesterol targets, but their effects on other lipids are less reported. This study was designed to examine lipid changes in subjects with ST-segment elevation myocardial infarction (STEMI) after two highly effective lipid-lowering therapies. Twenty patients with STEMI were randomized to be treated with rosuvastatin 20 mg QD or simvastatin 40 mg combined with ezetimibe 10 mg QD for 30 days. Fasting blood samples were collected on the first day (D1) and after 30 days (D30). Lipidomic analysis was performed using the Lipidyzer platform. Similar classic lipid profile was obtained in both groups of lipid-lowering therapies. However, differences with the lipidomic analysis were observed between D30 and D1 for most of the analyzed classes. Differences were noted with lipid-lowering therapies for lipids such as FA, LPC, PC, PE, CE, Cer, and SM, notably in patients treated with rosuvastatin. Correlation studies between classic lipid profiles and lipidomic results showed different information. These findings seem relevant, due to the involvement of these lipid classes in crucial mechanisms of atherosclerosis, and may account for residual cardiovascular risk.Randomized clinical trial: ClinicalTrials.gov, NCT02428374, registered on 28/09/2014.",2021,"Differences were noted with lipid-lowering therapies for lipids such as FA, LPC, PC, PE, CE, Cer, and SM, notably in patients treated with rosuvastatin.","['Twenty patients with STEMI', 'subjects with ST-segment elevation myocardial infarction (STEMI) after two highly effective lipid-lowering therapies', 'subjects with acute myocardial infarction']","['ezetimibe', 'rosuvastatin', 'rosuvastatin 20\xa0mg QD or simvastatin 40\xa0mg combined with ezetimibe 10\xa0mg QD', 'lipid-lowering therapies']","['Fasting blood samples', 'lipid changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C5136931', 'cui_str': 'rosuvastatin 20 MG [Ezallor]'}, {'cui': 'C0989916', 'cui_str': 'Simvastatin 40 MG'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1166438', 'cui_str': 'ezetimibe 10 MG'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.0932891,"Differences were noted with lipid-lowering therapies for lipids such as FA, LPC, PC, PE, CE, Cer, and SM, notably in patients treated with rosuvastatin.","[{'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Klassen', 'Affiliation': 'Department of Chemistry, Federal University of Sao Paulo (UNIFESP), Diadema, SP, Brazil. aline.klassen@unifesp.br.'}, {'ForeName': 'Andrea Tedesco', 'Initials': 'AT', 'LastName': 'Faccio', 'Affiliation': 'Center for Multiplatform Metabolomics Studies (CEMM), Institute of Chemistry, University of Sao Paulo (USP), Sao Paulo, SP, Brazil.'}, {'ForeName': 'Carolina Raissa Costa', 'Initials': 'CRC', 'LastName': 'Picossi', 'Affiliation': 'Center for Multiplatform Metabolomics Studies (CEMM), Institute of Chemistry, University of Sao Paulo (USP), Sao Paulo, SP, Brazil.'}, {'ForeName': 'Priscilla Bento Matos Cruz', 'Initials': 'PBMC', 'LastName': 'Derogis', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Dos Santos Ferreira', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Aline Soriano', 'Initials': 'AS', 'LastName': 'Lopes', 'Affiliation': 'Department of Chemistry, Federal University of Sao Paulo (UNIFESP), Diadema, SP, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Sussulini', 'Affiliation': 'Department of Analytical Chemistry, Laboratory of Bioanalytics and Integrated Omics (LaBIOmics), Institute of Chemistry, University of Campinas (UNICAMP), P.O. Box 6154, Campinas, SP, 13083-970, Brazil.'}, {'ForeName': 'Elisa Castañeda Santa', 'Initials': 'ECS', 'LastName': 'Cruz', 'Affiliation': 'Department of Analytical Chemistry, Laboratory of Bioanalytics and Integrated Omics (LaBIOmics), Institute of Chemistry, University of Campinas (UNICAMP), P.O. Box 6154, Campinas, SP, 13083-970, Brazil.'}, {'ForeName': 'Rafaela Tudela', 'Initials': 'RT', 'LastName': 'Bastos', 'Affiliation': 'Department of Chemistry, Federal University of Sao Paulo (UNIFESP), Diadema, SP, Brazil.'}, {'ForeName': 'Stefanie Caroline', 'Initials': 'SC', 'LastName': 'Fontoura', 'Affiliation': 'Department of Chemistry, Federal University of Sao Paulo (UNIFESP), Diadema, SP, Brazil.'}, {'ForeName': 'Antonio Martins Figueiredo', 'Initials': 'AMF', 'LastName': 'Neto', 'Affiliation': 'Institute of Physics, University of Sao Paulo (USP), Sao Paulo, SP, Brazil.'}, {'ForeName': 'Marina Franco Maggi', 'Initials': 'MFM', 'LastName': 'Tavares', 'Affiliation': 'Center for Multiplatform Metabolomics Studies (CEMM), Institute of Chemistry, University of Sao Paulo (USP), Sao Paulo, SP, Brazil.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Izar', 'Affiliation': 'Division of Cardiology, Department of Medicine, Federal University of Sao Paulo (UNIFESP), Rua Loefgren 1350, São Paulo, SP, CEP 04040-001, Brazil.'}, {'ForeName': 'Francisco Antonio Helfenstein', 'Initials': 'FAH', 'LastName': 'Fonseca', 'Affiliation': 'Division of Cardiology, Department of Medicine, Federal University of Sao Paulo (UNIFESP), Rua Loefgren 1350, São Paulo, SP, CEP 04040-001, Brazil. fahfonseca@terra.com.br.'}]",Scientific reports,['10.1038/s41598-021-95455-z']
1047,34365978,"Effectiveness and safety of Bifidobacterium and berberine in human hyperglycemia and their regulatory effect on the gut microbiota: a multi-center, double-blind, randomized, parallel-controlled study.","BACKGROUND


Berberine and Bifidobacterium have been reported to improve glucose tolerance in people with hyperglycemia or other metabolic disorders. This study aimed to assess the hypoglycemic effect and the regulation of the gut microbiota caused by berberine and Bifidobacterium and the possible additive benefits of their combination.
METHODS


This was an 18-week, multi-center, randomized, double-blind, parallel-controlled study of patients newly diagnosed with hyperglycemia. After a 2-week run-in period, 300 participants were randomly assigned to the following four groups for 16 weeks of treatment: berberine (Be), Bifidobacterium (Bi), berberine and Bifidobacterium (BB), and placebo group. The primary efficacy endpoint was the absolute value of fasting plasma glucose (FPG) compared with baseline after 16 weeks of treatment.
RESULTS


Between October 2015 and April 2018, a total of 297 participants were included in the primary analysis. Significant reductions of FPG were observed in the Be and BB groups compared with the placebo group, with a least square (LS) mean difference of - 0.50, 95% CI [- 0.85, - 0.15] mmol/L, and - 0.55, 95% CI [- 0.91, - 0.20] mmol/L, respectively. The Be and BB groups also showed significant reductions in 2-h postprandial plasma glucose. A pronounced decrease in HbA1c occurred in the BB group compared to the placebo group. Moreover, compared with the Bi and placebo groups, the Be and BB groups had more changes in the gut microbiota from the baseline.
CONCLUSIONS


Berberine could regulate the structure and function of the human gut microbiota, and Bifidobacterium has the potential to enhance the hypoglycemic effect of berberine. These findings provide new insights into the hypoglycemic potential of berberine and Bifidobacterium.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT03330184. Retrospectively registered on 18 October 2017.",2021,"Significant reductions of FPG were observed in the Be and BB groups compared with the placebo group, with a least square (LS) mean difference of - 0.50, 95% CI [- 0.85, - 0.15] mmol/L, and - 0.55, 95% CI [- 0.91, - 0.20] mmol/L, respectively.","['patients newly diagnosed with hyperglycemia', 'people with hyperglycemia or other metabolic disorders', '300 participants', 'Between October 2015 and April 2018, a total of 297 participants were included in the primary analysis']","['placebo', 'berberine (Be), Bifidobacterium (Bi), berberine and Bifidobacterium (BB), and placebo', 'Bifidobacterium and berberine']","['gut microbiota', 'hypoglycemic effect', '2-h postprandial plasma glucose', 'glucose tolerance', 'FPG', 'absolute value of fasting plasma glucose (FPG', 'HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0268329', 'cui_str': 'Other disorders of metabolism'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C2936720', 'cui_str': 'Hypoglycemic Effects'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",300.0,0.738204,"Significant reductions of FPG were observed in the Be and BB groups compared with the placebo group, with a least square (LS) mean difference of - 0.50, 95% CI [- 0.85, - 0.15] mmol/L, and - 0.55, 95% CI [- 0.91, - 0.20] mmol/L, respectively.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ming', 'Affiliation': ""Endocrinology Research Center, Department of Endocrinology and Metabolism, Xijing Hospital, Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Xinwen', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Endocrinology Research Center, Department of Endocrinology and Metabolism, Xijing Hospital, Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Aimigene Institute, Shenzhen, 518063, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Endocrinology Research Center, Department of Endocrinology and Metabolism, Xijing Hospital, Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Department of General Surgery, Nanjing Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Zhifeng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Aimigene Institute, Shenzhen, 518063, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""Department of Endocrinology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Sheli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, Affiliated Hospital of Yan'an University, Yan'an, China.""}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""The Fifth Department of Internal Medicine, Shaanxi Aerospace Hospital, Xi'an, China.""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': ""Genertec Universal Xi'an Aero-Engine Hospital, Xi'an, China.""}, {'ForeName': 'Qingzhen', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Endocrinology, Xi'an High-Tech Hospital, Xi'an, China.""}, {'ForeName': 'Yafang', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': ""Department of Endocrinology, Chang'an Hospital, Xi'an, China.""}, {'ForeName': 'Zhufang', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': ""Department of Endocrinology, Xi'an Central Hospital, Xi'an, China.""}, {'ForeName': 'Xiling', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Endocrinology, Yan'an People's Hospital, Yan'an, China.""}, {'ForeName': 'Kaiyan', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Shangluo Central Hospital, Shangluo, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Endocrinology Research Center, Department of Endocrinology and Metabolism, Xijing Hospital, Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Health Statistics, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology and Metabolism, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, 250021, China. jjzhao@sdu.edu.cn.'}, {'ForeName': 'Xiaokai', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Aimigene Institute, Shenzhen, 518063, China. wangxiaokai@aimigene.com.'}, {'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': ""Endocrinology Research Center, Department of Endocrinology and Metabolism, Xijing Hospital, Fourth Military Medical University, Xi'an, 710032, China. qiuheji@hotmail.com.""}]",Genome medicine,['10.1186/s13073-021-00942-7']
1048,34374430,Effects by educational attainment of a mammography screening patient decision aid for women aged 75 years and older.,"BACKGROUND


To help inform screening decisions, a mammography screening decision aid (DA) for women aged 75 years and older was tested in a cluster randomized clinical trial of 546 women. DA use increased women's knowledge of the benefits and harms of mammography and lowered screening rates. In the current study, the objective was to examine whether participants' views of the DA and/or its effects differed by educational attainment.
METHODS


A secondary analysis was conducted of 283 women who received the DA before a personal care provider (PCP) visit during the trial to examine the acceptability of the DA and its effects on knowledge of the benefits and harms of mammography, screening intentions, and receipt of screening by educational attainment. Adjusted analyses accounted for clustering by PCP.
RESULTS


Of the 283 participants, 43% had a college education or less. Regardless of educational attainment, 87.2% found the DA helpful. Women with lower educational attainment were less likely to understand all of the DA's content (46.3% vs 67.5%; P < .001), had less knowledge of the benefits and harms of mammography (adjusted mean ± standard error knowledge score, 7.1 ± 0.3 vs 8.1 ± 0.3; P < .001), and were less likely to lower screening intentions (adjusted percentage, 11.4% vs 19.4%; P = .01). Receipt of screening did not differ by educational attainment.
CONCLUSIONS


A mammography DA for women aged 75 years and older was helpful to women regardless of their educational attainment; however, those with a college degree or greater understood the DA and, possibly as a result, lowered their screening intentions. Future studies need to examine how to better support informed decision making around mammography screening in older women with lower educational attainment.
LAY SUMMARY


The authors examined data from a previous study to learn the effects of a mammography decision aid (DA) for women aged 75 years and older according to their level of education. Overall, women found the DA helpful, but women with lower educational attainment found it harder to understand the benefits and harms of mammography screening and were less likely to lower their screening intentions than women with a college degree. The findings suggest that women aged 75 years and older who have lower educational attainment may need an even lower literacy DA and/or more support from health care professionals.",2021,"Overall, women found the DA helpful, but women with lower educational attainment found it harder to understand the benefits and harms of mammography screening and were less likely to lower their screening intentions than women with a college degree.","['283 participants', '283 women who received the DA before a personal care provider (PCP) visit during the trial', 'older women with lower educational attainment', 'women aged 75\xa0years and older according to their level of education', 'women aged 75\xa0years and older who have lower educational attainment', 'women aged 75 years and older', '546 women', 'women aged 75\xa0years and older']","['mammography decision aid (DA', 'mammography DA', 'DA', 'mammography screening patient decision']","['benefits and harms of mammography screening', 'knowledge of the benefits and harms of mammography', ""women's knowledge of the benefits and harms of mammography and lowered screening rates"", 'screening intentions']","[{'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0203028', 'cui_str': 'Screening mammography'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",546.0,0.129495,"Overall, women found the DA helpful, but women with lower educational attainment found it harder to understand the benefits and harms of mammography screening and were less likely to lower their screening intentions than women with a college degree.","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Cadet', 'Affiliation': 'School of Social Policy and Practice, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Adlin', 'Initials': 'A', 'LastName': 'Pinheiro', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karamourtopoulos', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Alicia R', 'Initials': 'AR', 'LastName': 'Jacobson', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Gianna M', 'Initials': 'GM', 'LastName': 'Aliberti', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Kistler', 'Affiliation': 'Division of Geriatric Medicine and Department of Family Medicine, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Mara A', 'Initials': 'MA', 'LastName': 'Schonberg', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.33857']
1049,34373988,Effects of a 12-Week Transtheoretical Model-Based Exercise Training Program in Chinese Postoperative Bariatric Patients: a Randomized Controlled Trial.,"PURPOSE


This study aims to investigate the effectiveness of the transtheoretical model (TTM)-based exercise training on TTM variables, exercise adherence, and physical function in patients in the early stages after bariatric surgery (BS).
MATERIALS AND METHODS


We conducted a single-blinded, prospective, randomized controlled trial (RCT) to evaluate the effects of TTM-based exercise training on BS patients immediately after surgery. Participants (n = 120) were randomized into a TTM-based exercise training group (n = 60) and a control group (n = 60). Main outcomes included TTM variables (measured by exercise stages of change (ESCs), exercise self-efficacy (ESE), and decisional balance), exercise adherence, and physical function (determined by the 6-min walk distance (6MWD)). Secondary outcomes were physical activity, anthropometrics, and body composition. We performed all analyses in accordance with the intention-to-treat principle.
RESULTS


Retention rates for the interventions were 91.7% for the intervention group and 90.0% for the control group. Compared with the control group, the 12-week TTM-based intervention significantly helped participants advance through ESCs, demonstrate higher ESE, perceive more benefits and fewer barriers to exercise, and show higher exercise adherence and better physical function afterward (all P < 0.05). However, we observed no statistically significant difference between the two groups in anthropometric parameters or body composition after intervention.
CONCLUSION


The TTM-based exercise intervention had significant positive effects on the TTM variables, which could further help increase patients' exercise adherence and physical function immediately after BS.
TRIAL REGISTRATION


This study was retrospectively registered at the Chinese Clinical Trial Registry (website: www.chictr.org.cn , registry number: ChiCTR2000039319).",2021,"Compared with the control group, the 12-week TTM-based intervention significantly helped participants advance through ESCs, demonstrate higher ESE, perceive more benefits and fewer barriers to exercise, and show higher exercise adherence and better physical function afterward (all P < 0.05).","['Participants (n = 120', 'Chinese Postoperative Bariatric Patients', 'patients in the early stages after bariatric surgery (BS', 'BS patients immediately after surgery']","['TTM-based exercise intervention', '12-Week Transtheoretical Model-Based Exercise Training Program', 'transtheoretical model (TTM)-based exercise training', 'TTM-based exercise training']","['anthropometric parameters or body composition', 'Retention rates', 'TTM variables, exercise adherence, and physical function', 'exercise adherence and better physical function', 'physical activity, anthropometrics, and body composition', 'TTM variables (measured by exercise stages of change (ESCs), exercise self-efficacy (ESE), and decisional balance), exercise adherence, and physical function (determined by the 6-min walk distance (6MWD', ""patients' exercise adherence and physical function""]","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",120.0,0.0128556,"Compared with the control group, the 12-week TTM-based intervention significantly helped participants advance through ESCs, demonstrate higher ESE, perceive more benefits and fewer barriers to exercise, and show higher exercise adherence and better physical function afterward (all P < 0.05).","[{'ForeName': 'Ziqi', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'School of Nursing, Nanjing Medical University, 818 Tianyuan East Road, Jiangning District, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Hanfei', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'School of Nursing, Nanjing Medical University, 818 Tianyuan East Road, Jiangning District, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Tianzi', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Nursing, Jiangsu College of Nursing, Huai'an, 223000, Jiangsu, China.""}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Hua', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, Nanjing Medical University, 818 Tianyuan East Road, Jiangning District, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Ningli', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, Nanjing Medical University, 818 Tianyuan East Road, Jiangning District, Nanjing, 210029, Jiangsu, China. qinxu@njmu.edu.cn.'}]",Obesity surgery,['10.1007/s11695-021-05607-3']
1050,34375336,Immunogenicity of an oral rotavirus vaccine administered with prenatal nutritional support in Niger: A cluster randomized clinical trial.,"BACKGROUND


Nutritional status may play a role in infant immune development. To identify potential boosters of immunogenicity in low-income countries where oral vaccine efficacy is low, we tested the effect of prenatal nutritional supplementation on immune response to 3 doses of a live oral rotavirus vaccine.
METHODS AND FINDINGS


We nested a cluster randomized trial within a double-blind, placebo-controlled randomized efficacy trial to assess the effect of 3 prenatal nutritional supplements (lipid-based nutrient supplement [LNS], multiple micronutrient supplement [MMS], or iron-folic acid [IFA]) on infant immune response (n = 53 villages and 1,525 infants with valid serology results: 794 in the vaccine group and 731 in the placebo group). From September 2015 to February 2017, participating women received prenatal nutrient supplement during pregnancy. Eligible infants were then randomized to receive 3 doses of an oral rotavirus vaccine or placebo at 6-8 weeks of age (mean age: 6.3 weeks, 50% female). Infant sera (pre-Dose 1 and 28 days post-Dose 3) were analyzed for anti-rotavirus immunoglobulin A (IgA) using enzyme-linked immunosorbent assay (ELISA). The primary immunogenicity end point, seroconversion defined as ≥3-fold increase in IgA, was compared in vaccinated infants among the 3 supplement groups and between vaccine/placebo groups using mixed model analysis of variance procedures. Seroconversion did not differ by supplementation group (41.1% (94/229) with LNS vs. 39.1% (102/261) with multiple micronutrients (MMN) vs. 38.8% (118/304) with IFA, p = 0.91). Overall, 39.6% (n = 314/794) of infants who received vaccine seroconverted, compared to 29.0% (n = 212/731) of infants who received placebo (relative risk [RR]: 1.36; 95% confidence interval [CI]: 1.18, 1.57, p < 0.001). This study was conducted in a high rotavirus transmission setting. Study limitations include the absence of an immune correlate of protection for rotavirus vaccines, with the implications of using serum anti-rotavirus IgA for the assessment of immunogenicity and efficacy in low-income countries unclear.
CONCLUSIONS


This study showed no effect of the type of prenatal nutrient supplementation on immune response in this setting. Immune response varied depending on previous exposure to rotavirus, suggesting that alternative delivery modalities and schedules may be considered to improve vaccine performance in high transmission settings.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02145000.",2021,"Seroconversion did not differ by supplementation group (41.1% (94/229) with LNS vs. 39.1% (102/261) with multiple micronutrients (MMN) vs. 38.8% (118/304) with IFA, p = 0.91).","['infant immune response (n = 53 villages and 1,525 infants with valid serology results: 794 in the vaccine group and 731 in the placebo group', 'Niger', 'From September 2015 to February 2017, participating women received', 'Eligible infants']","['prenatal nutrient supplement', 'oral rotavirus vaccine or placebo', 'vaccine/placebo', 'prenatal nutritional supplementation', '3 prenatal nutritional supplements (lipid-based nutrient supplement [LNS], multiple micronutrient supplement [MMS], or iron-folic acid [IFA', 'placebo', 'oral rotavirus vaccine', 'prenatal nutrient supplementation']","['Seroconversion', 'vaccine performance', 'immunogenicity and efficacy', 'Immunogenicity', 'seroconversion defined as ≥3-fold increase in IgA']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C0281643', 'cui_str': ""incomplete Freund's adjuvant""}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}]",,0.509104,"Seroconversion did not differ by supplementation group (41.1% (94/229) with LNS vs. 39.1% (102/261) with multiple micronutrients (MMN) vs. 38.8% (118/304) with IFA, p = 0.91).","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Isanaka', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}, {'ForeName': 'Souna', 'Initials': 'S', 'LastName': 'Garba', 'Affiliation': 'Epicentre, Niamey, Niger.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Plikaytis', 'Affiliation': 'BioStat Consulting, LLC, Worthington, Ohio, United States of America.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Malone McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati, Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States of America.""}, {'ForeName': 'Ousmane', 'Initials': 'O', 'LastName': 'Guindo', 'Affiliation': 'Epicentre, Niamey, Niger.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Langendorf', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Adehossi', 'Affiliation': 'National Hospital, Niamey, Niger.'}, {'ForeName': 'Iza', 'Initials': 'I', 'LastName': 'Ciglenecki', 'Affiliation': 'Médecins Sans Frontières-Operational Center Geneva, Geneva, Switzerland.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Grais', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}]",PLoS medicine,['10.1371/journal.pmed.1003720']
1051,34379101,Response to a Randomized Trial on Mannitol Use During Partial Nephrectomy.,,2021,,[],['Mannitol Use'],[],[],"[{'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",[],,0.0600047,,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lewicki', 'Affiliation': 'Department of Urology, NewYork-Presbyterian Hospital, Weill Cornell Medicine, New York.'}, {'ForeName': 'Spyridon P', 'Initials': 'SP', 'LastName': 'Basourakos', 'Affiliation': 'Department of Urology, NewYork-Presbyterian Hospital, Weill Cornell Medicine, New York.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Arenas-Gallo', 'Affiliation': 'Department of Urology, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Scherr', 'Affiliation': 'Department of Urology, NewYork-Presbyterian Hospital, Weill Cornell Medicine, New York.'}, {'ForeName': 'Lee E', 'Initials': 'LE', 'LastName': 'Ponsky', 'Affiliation': 'Department of Urology, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shoag', 'Affiliation': 'Department of Urology, NewYork-Presbyterian Hospital, Weill Cornell Medicine, New York.'}]",JAMA surgery,['10.1001/jamasurg.2021.3598']
1052,34378307,Pharmacokinetic and pharmacodynamic bioequivalence between regular human insulin (rDNA origin) in 0.9% sodium chloride ready-to-use infusion 1 U/mL and 100 U/mL concentrate diluted to 1 U/mL in healthy males.,"AIM


To show pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence between Myxredlin, a novel, ready-to-use regular human insulin 1 U/mL formulation (BAX-HI), and Novolin R 100 U/mL concentrate diluted to 1 U/mL (NOVO-HI).
MATERIALS AND METHODS


This phase 1, double-blind, randomized, two-way crossover study compared the PK and PD properties of BAX-HI and NOVO-HI. A total of 58 healthy males received 0.36 U/kg of each study drug, administered intravenously over a 6-hour period, concurrent with an 8-hour euglycaemic clamp at two treatment periods separated by a washout period of 7-10 days. The primary PK endpoint was the area under the insulin concentration-time curve at steady state (SS) measured from 300 to 360 minutes (AUC INS-SS 300-360 min  ). The primary PD endpoint was the area under the glucose infusion rate-time curve at SS measured from 300 to 360 minutes (AUC GIR-SS 300-360 min  ).
RESULTS


All subjects completed the first treatment period and 54 subjects completed both treatment periods. Bioequivalence between BAX-HI and NOVO-HI was shown for the primary endpoints as the 90% confidence interval (CI) of the geometric least-squares (LS) mean ratio for AUC INS-SS 300-360 min  , and the 90% CI and 95% CI of the geometric LS mean ratio for AUC GIR-SS 300-360 min  were entirely contained within the prespecified limits of 80%-125%. Safety profiles were comparable for both study drugs and there were no serious adverse events.
CONCLUSIONS


The study showed bioequivalence between BAX-HI and NOVO-HI in terms of PK and PD characteristics in healthy males.",2021,Bioequivalence between BAX-HI and NOVO-HI was demonstrated for the primary endpoints as the 90% confidence interval (CI) of the geometric least-squares (LS) mean ratio for AUC INS-SS 300-360 min  and the 90% CI and 95% CI of the geometric LS mean ratio for AUC GIR-SS 300-360 min  were entirely contained within the prespecified limits of 80-125%.,"['Healthy Males', 'healthy males', '58 healthy males']",['regular human insulin [rDNA origin'],"['area under the insulin concentration-time curve at steady state (SS', 'pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence', 'Pharmacokinetic and Pharmacodynamic Bioequivalence', 'BAX-HI and NOVO-HI', 'Safety profiles', 'area under the glucose infusion rate-time curve at SS']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0795635', 'cui_str': 'Regular Insulin, Human'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0219474', 'cui_str': 'Bax Protein'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",58.0,0.215275,Bioequivalence between BAX-HI and NOVO-HI was demonstrated for the primary endpoints as the 90% confidence interval (CI) of the geometric least-squares (LS) mean ratio for AUC INS-SS 300-360 min  and the 90% CI and 95% CI of the geometric LS mean ratio for AUC GIR-SS 300-360 min  were entirely contained within the prespecified limits of 80-125%.,"[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hompesch', 'Affiliation': 'ProSciento, Inc., Chula Vista, California.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Hawryluk', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Warsaw, Poland.'}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': 'ProSciento, Inc., Chula Vista, California.'}, {'ForeName': 'Beena', 'Initials': 'B', 'LastName': 'Uchil', 'Affiliation': 'Celerity Pharmaceuticals, LLC, Rosemont, Illinois.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Wilmington', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Peterson', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14520']
1053,34383175,Antistaphylococcal penicillins vs. cefazolin in the treatment of methicillin-susceptible Staphylococcus aureus infective endocarditis: a quasi-experimental monocentre study.,"Whether cefazolin is as effective and safer than antistaphylococcal penicillins (ASPs) for the treatment of methicillin-susceptible Staphylococcus aureus (MSSA) infective endocarditis (IE) is still debated in the absence of a randomized controlled trial. In this quasi-experimental study, we aimed to assess the effectiveness and safety of these two treatments in MSSA-IE, using the ASPs nationwide shortage in April 2016 as a unique opportunity to overcome the indication bias associated with observational studies. In this single-centre study, we compared patients with Duke-Li definite MSSA-IE treated with ASPs from January 2015 to March 2016 versus those treated with cefazolin from April 2016 to December 2018, when ASPs were not available. Effectiveness outcome was 90-day all-cause mortality. Safety outcomes included significant decrease in GFR and significant increase in serum liver enzymes. Logrank test was used to compare survival rates. Of 73 patients with MSSA-IE, 35 and 38 were treated with ASPs and cefazolin, respectively. Baseline patients' characteristics (demography, native or prosthetic valve IE, clinical characteristics, cardiac and septic complications) were similar between groups. Ninety-day all-cause mortality was 28.6% and 21.1%, in patients treated with ASPs and cefazolin, respectively (logrank p = 0.5727). There was no difference between groups for incident renal or liver toxicity events: acute kidney injury 45.7% vs. 44.7% (p = 0.933), increased ALT 5.7% vs. 13.2% (p = 0.432), bilirubin increase 5.7% vs. 10.5% (p = 0.676), in ASPs vs. cefazolin groups, respectively. In this quasi-experimental, effectiveness and safety did not statistically differ between ASPs and cefazolin for MSSA-IE treatment.",2021,"In this quasi-experimental, effectiveness and safety did not statistically differ between ASPs and cefazolin for MSSA-IE treatment.","['methicillin-susceptible Staphylococcus aureus infective endocarditis', 'patients with Duke-Li definite MSSA-IE treated with ASPs from January 2015 to March 2016 versus those treated with', '73 patients with MSSA-IE, 35 and 38 were treated with']","['ASPs and cefazolin', 'Antistaphylococcal penicillins vs. cefazolin', 'cefazolin']","[""Baseline patients' characteristics (demography, native or prosthetic valve IE, clinical characteristics, cardiac and septic complications"", 'survival rates', 'effectiveness and safety', 'serum liver enzymes', 'cause mortality', 'incident renal or liver toxicity events: acute kidney injury', 'GFR', 'bilirubin']","[{'cui': 'C1635274', 'cui_str': 'Methicillin susceptible Staphylococcus aureus'}, {'cui': 'C0014121', 'cui_str': 'Bacterial endocarditis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0336548', 'cui_str': 'Prosthetic valve'}, {'cui': 'C0014121', 'cui_str': 'Bacterial endocarditis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}]",73.0,0.0560824,"In this quasi-experimental, effectiveness and safety did not statistically differ between ASPs and cefazolin for MSSA-IE treatment.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lefèvre', 'Affiliation': 'Infectious and Tropical Diseases, CHRU-Nancy, Université de Lorraine, 54000, Nancy, France. b.lefevre@chru-nancy.fr.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hoen', 'Affiliation': 'Infectious and Tropical Diseases, CHRU-Nancy, Université de Lorraine, 54000, Nancy, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Goehringer', 'Affiliation': 'Infectious and Tropical Diseases, CHRU-Nancy, Université de Lorraine, 54000, Nancy, France.'}, {'ForeName': 'W Ngueyon', 'Initials': 'WN', 'LastName': 'Sime', 'Affiliation': 'INSERM, CIC-EC, Epidémiologie clinique, CHRU-Nancy, 54000, Nancy, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Aissa', 'Affiliation': 'Service de Microbiologie, CHRU-Nancy, 54000, Nancy, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Alauzet', 'Affiliation': 'Service de Microbiologie, CHRU-Nancy, 54000, Nancy, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jeanmaire', 'Affiliation': 'Infectious and Tropical Diseases, CHRU-Nancy, Université de Lorraine, 54000, Nancy, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hénard', 'Affiliation': 'Infectious and Tropical Diseases, CHRU-Nancy, Université de Lorraine, 54000, Nancy, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Filippetti', 'Affiliation': 'Cardiology, CHRU-Nancy, 54000, Nancy, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Selton-Suty', 'Affiliation': 'Cardiology, CHRU-Nancy, 54000, Nancy, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Agrinier', 'Affiliation': 'APEMAC, Université de Lorraine, 54000, Nancy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-021-04313-3']
1054,34380024,Bilateral vs Unilateral Arm Training for Patients With Stroke.,,2021,,['patients with stroke'],['Bilateral versus unilateral arm training'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0220793,,"[{'ForeName': 'Yi-Hsiang', 'Initials': 'YH', 'LastName': 'Chiu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Kuan-Cheng', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.05.020']
1055,34380000,High-intensity interval training or resistance training versus usual care in men with prostate cancer on active surveillance: a 3-arm feasibility randomized controlled trial.,"This study assessed the feasibility of a phase II randomized controlled trial of high-intensity interval training (HIIT), resistance training (RT), and usual care (UC) in men with prostate cancer (PCa) on active surveillance and evaluated changes in clinically relevant outcomes. Eighteen men undergoing active surveillance for PCa were randomized to HIIT ( n  = 5), RT ( n  = 7), or UC ( n  = 6). Exercise participants attended 2 supervised sessions weekly and were instructed to complete 1 home-based session weekly for 8 weeks. UC participants were provided with physical activity guidelines. Feasibility was met for attendance, compliance, and retention, but not recruitment. HIIT increased leg press (mean: +8.2 kg, 95% CI 1.1 to 15.3) from baseline to 8 weeks. RT increased seated row (mean: +11.7 kg, 95% CI 6.1 to 17.3), chest press (mean: +10.4 kg, 95% CI 5.3 to 15.5), leg press (mean: +13.1 kg, 95% CI 5.9 to 20.3), serum insulin-like binding protein-3 (IGFBP-3) (mean: +400.0 ng/mL, 95% CI 94.5 to 705.5), and decreased interferon-γ (mean: -3.1 pg/mL, 95% CI -5.7 to -0.4). No changes were observed in the UC group. HIIT and RT may be effective strategies for improving muscle strength; however, only RT may increase serum IGFBP-3. Strategies that can enhance recruitment in men on active surveillance are important prior to conducting a phase II trial. Trial registration number: ClinicalTrials.gov number NCT04266262.  Novelty:  High-intensity interval training or resistance training are feasible during active surveillance for prostate cancer. Resistance training may suppress the tumour-promoting effects of insulin-like growth factor-I (IGF-I) via increased expression of IGFBP-3.",2021,"HIIT increased leg press (mean: +8.2kg, 95%CI 1.1, 15.3) from baseline to 8 weeks.","['Eighteen men undergoing AS for PCa were randomized to HIIT (n=5), RT (n=7), or UC (n=6', 'men with prostate cancer on active surveillance', 'men with prostate cancer (PCa']","['high-intensity interval training (HIIT), resistance training (RT), and usual care (UC', 'Resistance training', 'High-intensity interval training or resistance training versus usual care', 'High-intensity interval training or resistance training']","['HIIT increased leg press', 'serum insulin-like binding protein-3 (IGFBP-3', 'leg press']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0443625', 'cui_str': 'Binding protein 3'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}]",18.0,0.0898601,"HIIT increased leg press (mean: +8.2kg, 95%CI 1.1, 15.3) from baseline to 8 weeks.","[{'ForeName': 'Efthymios', 'Initials': 'E', 'LastName': 'Papadopoulos', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Gillen', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Moore', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Au', 'Affiliation': 'Department of Anesthesia and Pain Management, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Kurgan', 'Affiliation': 'Faculty of Applied Health Sciences, Brock University, Saint Catharines, ON, Canada.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Klentrou', 'Affiliation': 'Faculty of Applied Health Sciences, Brock University, Saint Catharines, ON, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Finelli', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Shabbir M H', 'Initials': 'SMH', 'LastName': 'Alibhai', 'Affiliation': 'Department of Medicine, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Santa Mina', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2021-0365']
1056,34385027,Sinus-like versus random vibration: Acute effects on elderly people with a high risk of falling.,"BACKGROUND


Whole-body vibration (WBV) could be an alternative training method for elderly with a high risk of falling.
RESEARCH QUESTION


What acute effects of sinus-like and random WBV intervention occur in this risk group and how do they differ?
METHODS


This prospective pilot study was performed on two days separated by a one-week wash-out phase. Twelve subjects (10 women and 2 men, age 77.7 ± 5.3; 162.3 ± 7.4 cm; 82.4 ± 15.2 kg; BMI 31.2 ± 5.1 kg/m²) undertook sinus-like WBV intervention. One week later random WBV were performed. This consisted of six intervals each lasting 60 s, with heart and respiratory rates monitored. Feasibility outcomes involved safety and compliance. The primary endpoint was postural control, measured by a static posturography before and after the first interval and complete intervention. Secondary outcomes measured before and after the intervention were a Timed-Up-and-Go-Test (TUGT) and an instrumental gait analysis.
RESULTS


Random WBV intervention showed positive acute effect on postural control (Standard deviation (SD) Ellipse area p = 0.007; SD of the Center of force (CoF) independent from direction p = 0.017; SD of the CoF in the antero-posterior direction p = 0.011). There were no significant acute effects on TUGT or gait analysis (comparison between sinus-like and random WBV: Single Task: ΔVelocity p = 0.373, ΔStep time p = 0.077, ΔStep length p = 0.369, ΔStride length p = 0.408, ΔDouble-support-time p = 0.492; Dual task: ΔVelocity p = 0.580, ΔStep-time p = 0.559, ΔStep length p = 0.626, ΔStride length p = 0.584, ΔDouble-support-time p = 0.550). During sinus-like WBV, heart rate increased significantly from rest 69.7 ± 20.9bpm to max.146.0 ± 24.9bpm (p = 0.025). Respiratory rate increased significantly from 10.0 ± 1.0 to max.32.0 ± 6.0 (p = 0.011) during random WBV. No undesirable side effects were observed.
SIGNIFICANCE


Findings demonstrate that random WBV improves acute functional ability of postural control, but not gait for elderly people with a high risk of falling. Intervention with WBV seems safe and well accepted by participants. Monitoring of heart and respiratory rate offers protection for subjects with heart disease.",2021,"There were no significant acute effects on TUGT or gait analysis (comparison between sinus-like and random WBV: Single Task: ΔVelocity p = 0.373, ΔStep time p = 0.077, ΔStep length p = 0.369, ΔStride length p = 0.408, ΔDouble-support-time p = 0.492; Dual task: ΔVelocity p = 0.580, ΔStep-time p = 0.559, ΔStep length p = 0.626, ΔStride length p = 0.584, ΔDouble-support-time p = 0.550).","['elderly with a high risk of falling', 'subjects with heart disease', 'Twelve subjects (10 women and 2 men, age 77.7 ± 5.3; 162.3 ± 7.4 cm; 82.4 ± 15.2 kg; BMI 31.2 ± 5.1 kg/m²) undertook sinus-like WBV intervention', 'elderly people with a high risk of falling']","['Sinus-like versus random vibration', 'Whole-body vibration (WBV', 'random WBV']","['acute functional ability of postural control', 'Respiratory rate', 'postural control, measured by a static posturography', 'positive acute effect on postural control', 'heart rate', 'undesirable side effects', 'acute effects on TUGT or gait analysis', 'safety and compliance', 'Timed-Up-and-Go-Test (TUGT) and an instrumental gait analysis']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5191319', 'cui_str': '31.2'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",10.0,0.0392162,"There were no significant acute effects on TUGT or gait analysis (comparison between sinus-like and random WBV: Single Task: ΔVelocity p = 0.373, ΔStep time p = 0.077, ΔStep length p = 0.369, ΔStride length p = 0.408, ΔDouble-support-time p = 0.492; Dual task: ΔVelocity p = 0.580, ΔStep-time p = 0.559, ΔStep length p = 0.626, ΔStride length p = 0.584, ΔDouble-support-time p = 0.550).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kiehl', 'Affiliation': 'Hannover Medical School (MHH), Institute of Sports Medicine, Hannover, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Stein', 'Affiliation': 'Hannover Medical School (MHH), Institute of Sports Medicine, Hannover, Germany. Electronic address: Stein.Lothar@mh-hannover.de.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Kerling', 'Affiliation': 'Hannover Medical School (MHH), Institute of Sports Medicine, Hannover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Hannover Medical School (MHH), Institute of Sports Medicine, Hannover, Germany.'}, {'ForeName': 'Tobias S', 'Initials': 'TS', 'LastName': 'Kaeding', 'Affiliation': 'Hannover Medical School (MHH), Institute of Sports Medicine, Hannover, Germany; Leibniz University Hannover, Institute of Sport Science, Department of Sport and Health, Hannover, Germany.'}]",Gait & posture,['10.1016/j.gaitpost.2021.07.018']
1057,34384941,Inertial flywheel vs heavy slow resistance training among athletes with patellar tendinopathy: A randomised trial.,"OBJECTIVES


To compare the efficacy of inertial flywheel and heavy slow resistance training in reducing pain and improving function in patellar tendinopathy.
DESIGN


Randomised clinical trial.
METHODS


Fourty two participants (1 woman, 41 men) with longstanding (>3 months) patellar tendinopathy were randomised into inertial flywheel resistance (N = 21) or heavy slow resistance (N = 21) group. Both programmes consisted of three supervised inertial flywheel or heavy slow resistance exercise sessions per week in a fitness center during 12 weeks. Primary outcome was pain and function, assessed by the Spanish Victorian Institute of Sport Assessment for Patella (VISA-P) score at 6 and 12 weeks. Secondary outcomes were activity limitation using Patient Specific Functional Scale (PSFS), health status (EuroQol-5D), patient impression of change on pain and function, adherence, adverse events, pain provocation test for the patellar tendon (numerical rating score of pain between 0 and 10), physical test, patellar tendon thickness and doppler signal on ultrasound. Secondary outcomes were taken at 0 and 12 weeks.
RESULTS


Both groups showed significant improvements in VISA-P scores from 0 to 12 weeks but there was not statistically significant between-group difference (P = 0.506). No adverse events or side effects occurred in any of the groups during the intervention period.
CONCLUSIONS


Inertial flywheel resistance three times a week during 12 weeks resulted in similar pain and function benefit at 12 weeks compared with the heavy slow resistance training among people with patellar tendinopathy. Flywheel training is another exercise option for managing people with patellar tendinopathy. CLINICALTRIALS.
GOV REGISTRY


NCT03917849.",2021,Both groups showed significant improvements in VISA-P scores from 0 to 12 weeks but there was not statistically significant between-group difference (P = 0.506).,"['managing people with patellar tendinopathy', 'athletes with patellar tendinopathy', 'Fourty two participants (1 woman, 41 men) with longstanding (>3 months) patellar tendinopathy', 'people with patellar tendinopathy']","['Flywheel training', 'supervised inertial flywheel or heavy slow resistance exercise sessions', 'Inertial flywheel vs heavy slow resistance training', 'heavy slow resistance training', 'inertial flywheel resistance (N\xa0=\xa021) or heavy slow resistance', 'inertial flywheel and heavy slow resistance training']","['VISA-P scores', 'activity limitation using Patient Specific Functional Scale (PSFS), health status (EuroQol-5D), patient impression of change on pain and function, adherence, adverse events, pain provocation test for the patellar tendon (numerical rating score of pain between 0 and 10), physical test, patellar tendon thickness and doppler signal on ultrasound', 'pain and function, assessed by the Spanish Victorian Institute of Sport Assessment for Patella (VISA-P) score', 'adverse events or side effects', 'similar pain and function benefit']","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",41.0,0.128523,Both groups showed significant improvements in VISA-P scores from 0 to 12 weeks but there was not statistically significant between-group difference (P = 0.506).,"[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Ruffino', 'Affiliation': 'Escuela de Kinesiología y Fisioterapia, Facultad de Ciencias Médicas, Universidad Nacional de Córdoba, Enrique Barros, Ciudad Universitaria, 5000, Córdoba, Argentina. Electronic address: diegoruffino@unc.edu.ar.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malliaras', 'Affiliation': 'Physiotherapy Department, School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Sciences, Monash University, Frankston, Victoria, 3199, Australia. Electronic address: peter.malliaras@monash.edu.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Marchegiani', 'Affiliation': 'Centro de Diagnóstico por Imágenes Marchegiani, Córdoba, Argentina. Electronic address: silviomarchegiani@hotmail.com.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Campana', 'Affiliation': 'Cátedra Física Biomédica, Facultad de Ciencias Médicas, Universidad Nacional de Córdoba, Santa Rosa 1085, 5000, Cordoba, Argentina. Electronic address: campanav@hotmail.com.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.08.002']
1058,33832957,"Efficacy and Safety of Mulberry Twig Alkaloids Tablet for the Treatment of Type 2 Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy, and Parallel Controlled Clinical Trial.","OBJECTIVE


This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids [SZ-A]) in the treatment of type 2 diabetes (T2D).
RESEARCH DESIGN AND METHODS


This was a multicenter, randomized, double-blind, double-dummy, and parallel controlled noninferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group ( n   =  360) or acarbose group ( n   =  240). The primary efficacy end point was the change of glycosylated hemoglobin (HbA 1c ) compared with baseline. In addition, adverse events (AEs), severe AEs (SAEs), treatment-related AEs (TAEs), and gastrointestinal disorders (GDs) were monitored.
RESULTS


After treatment for 24 weeks, the change in HbA 1c  was -0.93% (95% CI -1.03 to -0.83) (-10.2 mmol/mol [-11.3 to -9.1]) and -0.87% (-0.99 to -0.76) (-9.5 mmol/mol [-10.8 to -8.3]) in the SZ-A and acarbose groups, respectively, and the least squares mean difference was -0.05% (95% CI -0.18 to 0.07) (-0.5 mmol/mol [-2.0 to 0.8]) between the two groups, with no significant difference on the basis of covariance analysis ( P  > 0.05). The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group ( P  < 0.01), but no differences for AEs or SAEs between the two groups were observed ( P  > 0.05).
CONCLUSIONS


SZ-A exhibited equivalent hypoglycemic effects to acarbose in patients with T2D. Nevertheless, the incidence of TAEs and GDs was lower following SZ-A treatment than acarbose treatment, suggesting good safety.",2021,"The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group ( P  < 0.01), but no differences for AEs or SAEs between the two groups were observed ( P  > 0.05).
","['patients with T2D', 'type 2 diabetes (T2D', 'Type 2', 'Diabetes', '600 patients']","['Mulberry Twig Alkaloids Tablet', 'mulberry twig alkaloids (Sangzhi alkaloids [SZ-A', 'SZ-A group ( n   =  360) or acarbose', 'acarbose']","['change in HbA 1c', 'Efficacy and Safety', 'adverse events (AEs), severe AEs (SAEs), treatment-related AEs (TAEs), and gastrointestinal disorders (GDs', 'change of glycosylated hemoglobin (HbA 1c ', 'incidence of TAEs and GDs', 'efficacy and safety', 'hypoglycemic effects', 'AEs or SAEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0330540', 'cui_str': 'Morus'}, {'cui': 'C0002062', 'cui_str': 'Alkaloid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3163695', 'cui_str': 'Transarterial embolization'}, {'cui': 'C2936720', 'cui_str': 'Hypoglycemic Effects'}]",600.0,0.723153,"The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group ( P  < 0.01), but no differences for AEs or SAEs between the two groups were observed ( P  > 0.05).
","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Qu', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China xcliang@vip.sina.com gq_tian@126.com.'}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Tian', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China xcliang@vip.sina.com gq_tian@126.com.'}, {'ForeName': 'Gaili', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qunli', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiumei', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yazhong', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhufang', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital, Guangxi Medical University, Guangxi, China.'}, {'ForeName': 'Yingfen', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital, Guangxi Medical University, Guangxi, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital, Nan Jing Medical University, Jiangsu, China.'}, {'ForeName': 'Yongyan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Ziling', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Inner Mongolia Baogang Hospital, Baotou, Inner Mongolia Autonomous Region, China.'}, {'ForeName': 'Shandong', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of University of Science and Technology of China (USTC), Division of Life Sciences and Medicine, USTC, Hefei, Anhui, China.'}, {'ForeName': 'Xuezhi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Traditional Chinese Medicine and Integrative Medicine Department, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital, Shanxi Medical University, Shanxi, China.'}, {'ForeName': 'Guiwen', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': 'Department of Endocrinology, The Fourth Affiliated Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Traditional Chinese Medicine, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Gangyi', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital, Suzhou University, Jiangsu, China.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, The First People's Hospital of Yueyang, Hunan, China.""}, {'ForeName': 'Zhengfang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital, Kunming Medical University, Yunnan, China.'}, {'ForeName': 'Yukun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital, Hebei Medical University, Hebei, China.'}, {'ForeName': 'Xiuzhen', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Tongji Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Guangde', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Qilu Hospital, Shandong University, Shandong, China.'}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Hua', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Wuxi, Jiangsu, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Endocrinology, Central Hospital of Putuo District, Shanghai, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Endocrinology, West China Hospital, Sichuan University, Sichuan, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Bengbu Medical College, Anhui, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Liaoning, China.'}]",Diabetes care,['10.2337/dc20-2109']
1059,33832406,Atypical antipsychotics in the treatment of patients with a dual diagnosis of schizophrenia spectrum disorders and substance use disorders: the results of a randomized comparative study.,"The article presents the results of a randomized comparative study of Aripiprazole and Quetiapine in the treatment of patients with a dual diagnosis: schizophrenia and substance use disorders. During the study, 90 of the 266 male patients were screened. Among them, 54 individuals (60%) had a previously established diagnosis of mental disorder and 36 patients (40%) had no established psychiatric diagnosis. They were randomly randomized into three groups of 30 patients, each receiving an antipsychotic: Aripiprazole at a dose of up to 20 mg daily, Quetiapine at a dose of up to 600 mg daily, or Haloperidol at a dose of up to 30 mg daily. The efficacy of Aripiprazole and Quetiapine was evaluated using the following scales: PANSS, BPRS, VAS, and Substance Craving Scale (SCS). Drug safety was assessed by the development of adverse events, serious adverse events, or adverse reactions. Study results demonstrated the efficacy of atypical antipsychotics in the three groups. Analysis of independent variables showed significant differences between Aripiprazole and Haloperidol in PANSS and BPRS scores by Visit 4, in VAS scores by Visit 3, and in SCS scores by Visit 2. Intergroup analysis of independent variables showed significant differences between Quetiapine and Haloperidol in PANSS, VAS, and SCS scores by Visit 4. Intergroup analysis of independent variables showed significant differences between Aripiprazole and Quetiapine in the VAS and SCS scores. The correlation analysis allowed drawing conclusions about the close connection of the symptoms of schizophrenia and substance use disorders in patients with a dual diagnosis.",2021,"Analysis of independent variables showed significant differences between Aripiprazole and Haloperidol in PANSS and BPRS scores by Visit 4, in VAS scores by Visit 3, and in SCS scores by Visit 2.","['patients with a dual diagnosis: schizophrenia and substance use disorders', 'patients with a dual diagnosis', 'patients with a dual diagnosis of schizophrenia spectrum disorders and substance use disorders', '266 male patients were screened', '54 individuals (60%) had a previously established diagnosis of mental disorder and 36 patients (40%) had no established psychiatric diagnosis']","['Aripiprazole and Quetiapine', 'Quetiapine and Haloperidol', 'Quetiapine', 'antipsychotic: Aripiprazole', 'Atypical antipsychotics', 'Aripiprazole and Haloperidol', 'Aripiprazole', 'Haloperidol']","['efficacy of atypical antipsychotics', 'Drug safety', 'VAS scores', 'adverse events, serious adverse events, or adverse reactions', 'PANSS and BPRS scores', 'PANSS, VAS, and SCS scores', 'SCS scores', 'VAS and SCS scores', 'BPRS, VAS, and Substance Craving Scale (SCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206308', 'cui_str': 'Dual Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332139', 'cui_str': 'Established diagnosis'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0376338', 'cui_str': 'Psychiatric Diagnosis'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",266.0,0.0168429,"Analysis of independent variables showed significant differences between Aripiprazole and Haloperidol in PANSS and BPRS scores by Visit 4, in VAS scores by Visit 3, and in SCS scores by Visit 2.","[{'ForeName': 'V Yu', 'Initials': 'VY', 'LastName': 'Skryabin', 'Affiliation': 'Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Moscow, Russia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Vinnikova', 'Affiliation': 'Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Moscow, Russia.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Ezhkova', 'Affiliation': 'Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Moscow, Russia.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Titkov', 'Affiliation': 'Psychiatry and Psychotherapy Division, European Medical Centre, Moscow, Russia.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bulatova', 'Affiliation': 'Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Moscow, Russia.'}]",Journal of addictive diseases,['10.1080/10550887.2021.1905589']
1060,33837906,A randomized clinical trial evaluating the immunomodulatory effect of convalescent plasma on COVID-19-related cytokine storm.,"Evaluating the effect of convalescent plasma (CP) on some cytokine storm indices in severe COVID-19 patients. Totally, 62 patients were randomly assigned into two groups for this clinical trial. Patients in the intervention group received one unit (500 mL) plasma on the admission day plus standard drugs while the controls merely received standard treatments. Eventually, primary and secondary outcomes were evaluated. In the CP group, compared with controls, the mean levels of lymphocytes and IL-10 significantly increased while the levels of IL-6, TNF-α, and IFN-γ decreased (p < 0.05). The length of in-hospital stay, and mortality rate did not significantly reduce in the CP group compared with controls (p > 0.05) while WHO severity scores remarkably improved (p = 0.01), despite the higher frequency of underlying diseases among the CP group (66.7%) vs. controls (33.3%). Although CP has a remarkable immunomodulatory and antiviral potential to improve the cytokine storm and disease severity in COVID-19 patients, it did not considerably affect the mortality rate.",2021,"In the CP group, compared with controls, the mean levels of lymphocytes and IL-10 significantly increased while the levels of IL-6, TNF-α, and IFN-γ decreased (p < 0.05).","['severe COVID-19 patients', '62 patients']","['CP', 'one unit (500\xa0mL) plasma on the admission day plus standard drugs while the controls merely received standard treatments', 'convalescent plasma (CP']","['levels of IL-6, TNF-α, and IFN-γ', 'mean levels of lymphocytes and IL-10', 'COVID-19-related cytokine storm', 'WHO severity scores', 'length of in-hospital stay, and mortality rate', 'mortality rate', 'frequency of underlying diseases']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0919747', 'cui_str': 'Cytokine storm'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",62.0,0.0516912,"In the CP group, compared with controls, the mean levels of lymphocytes and IL-10 significantly increased while the levels of IL-6, TNF-α, and IFN-γ decreased (p < 0.05).","[{'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Pouladzadeh', 'Affiliation': 'Emergency Medicine Department, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Safdarian', 'Affiliation': 'Nanotechnology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. msafdaryan@gmail.com.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Eshghi', 'Affiliation': 'Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Abolghasemi', 'Affiliation': 'Applied Microbiology Research Center, Systems Biology and Poisonings Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza Ghorbani', 'Initials': 'AG', 'LastName': 'Bavani', 'Affiliation': 'Radiology Department, Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Sheibani', 'Affiliation': 'Infectious Diseases Department, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Parastoo', 'Initials': 'P', 'LastName': 'Moradi Choghakabodi', 'Affiliation': 'Thalassemia and Hemoglobinopathy Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. parastoomoradi40@yahoo.com.'}, {'ForeName': 'Abdolaziz', 'Initials': 'A', 'LastName': 'Feghhi', 'Affiliation': 'Blood Transfusion Organization, Ahvaz, Khuzestan, Iran.'}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Ghafourian Boroujerdnia', 'Affiliation': 'Department of Immunology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Forouzan', 'Affiliation': 'Department of Emergency Medicine, Imam Khomeini General Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Jalali Far', 'Affiliation': 'Thalassemia and Hemoglobinopathy Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Gholam Abbas', 'Initials': 'GA', 'LastName': 'Kaydani', 'Affiliation': 'Department of Laboratory Sciences, Allied Health Sciences School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Rajaei', 'Affiliation': 'Department of Internal Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Amin', 'Affiliation': 'Department of Microbiology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Torabizadeh', 'Affiliation': 'Golestan Hospital Clinical Research Development Unit, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Yousefi', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Health Research Institute, Ahvaz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Hadaddezfuli', 'Affiliation': 'Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Internal and emergency medicine,['10.1007/s11739-021-02734-8']
1061,33833278,"Impact of acute partial-body cryostimulation on cognitive performance, cerebral oxygenation, and cardiac autonomic activity.","We assessed the effects of a 3-min partial-body cryostimulation (PBC) exposure-where the whole body is exposed to extreme cold, except the head-on cognitive inhibition performance and the possible implications of parasympathetic cardiac control and cerebral oxygenation. In a randomized controlled counterbalanced cross-over design, eighteen healthy young adults (nine males and nine females) completed a cognitive Stroop task before and after one single session of PBC (3-min exposure at - 150 °C cold air) and a control condition (3 min at room temperature, 20 °C). During the cognitive task, heart rate variability (HRV) and cerebral oxygenation of the prefrontal cortex were measured using heart rate monitoring and near-infrared spectroscopy methods. We also recorded the cerebral oxygenation during the PBC session. Stroop performance after PBC exposure was enhanced (562.0 ± 40.2 ms) compared to pre-PBC (602.0 ± 56.4 ms; P < 0.042) in males only, accompanied by an increase (P < 0.05) in HRV indices of parasympathetic tone, in greater proportion in males compared to females. During PBC, cerebral oxygenation decreased in a similar proportion in males and females but the cerebral extraction (deoxyhemoglobin: ΔHHb) remained higher after exposure in males, only. These data demonstrate that a single PBC session enhances the cognitive inhibition performance on a Stroop task in males, partly mediated by a greater parasympathetic cardiac control and greater cerebral oxygenation. The effects of PBC on cognitive function seem different in females, possibly explained by a different sensitivity to cold stimulation.",2021,"Stroop performance after PBC exposure was enhanced (562.0 ± 40.2 ms) compared to pre-PBC (602.0 ± 56.4 ms; P < 0.042) in males only, accompanied by an increase (P < 0.05) in HRV indices of parasympathetic tone, in greater proportion in males compared to females.",['eighteen healthy young adults (nine males and nine females'],"['PBC', 'cognitive Stroop task before and after one single session of PBC (3-min exposure at -\u2009150\xa0°C cold air) and a control condition', '3-min partial-body cryostimulation (PBC) exposure']","['HRV indices of parasympathetic tone', 'Stroop performance after PBC exposure', 'cerebral oxygenation', 'cognitive task, heart rate variability (HRV) and cerebral oxygenation of the prefrontal cortex', 'cognitive inhibition performance', 'cognitive performance, cerebral oxygenation, and cardiac autonomic activity', 'cognitive function']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",18.0,0.0211537,"Stroop performance after PBC exposure was enhanced (562.0 ± 40.2 ms) compared to pre-PBC (602.0 ± 56.4 ms; P < 0.042) in males only, accompanied by an increase (P < 0.05) in HRV indices of parasympathetic tone, in greater proportion in males compared to females.","[{'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Theurot', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, 8 allée Jean Monnet, 86000, Poitiers, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Dugué', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, 8 allée Jean Monnet, 86000, Poitiers, France.'}, {'ForeName': 'Wafa', 'Initials': 'W', 'LastName': 'Douzi', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, 8 allée Jean Monnet, 86000, Poitiers, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guitet', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, 8 allée Jean Monnet, 86000, Poitiers, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Louis', 'Affiliation': 'Research Institute for Sport and Exercise Sciences (RISES), Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, UK.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dupuy', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, 8 allée Jean Monnet, 86000, Poitiers, France. olivier.dupuy@univ-poitiers.fr.'}]",Scientific reports,['10.1038/s41598-021-87089-y']
1062,34358819,The effect of intranasally administered oxytocin on observed social behavior in social anxiety disorder.,"Research has shown that patients with a social anxiety disorder (SAD) show social performance deficits. These deficits are a maintaining factor in SAD, as mending social behavior improves interpersonal judgments and reduces social anxiety. Thus finding ways to enhance social behavior is evidently of importance in the treatment of SAD. This double-blind, placebo-controlled study investigated the effect of an intranasal administration of the hormone oxytocin (24 IU) on social behavior and anxious appearance in SAD patients (N = 40) and healthy controls (N = 39). Forty minutes after oxytocin administration participants were submitted to two live social situations (i.e., a waiting room situation and a getting acquainted task). The participants ('self-rated') and observers ('observer-rated') scored participants' social behavior and anxious appearance. Participants also rated their positive and negative affect. Confirming the social performance deficits in SAD, observers regarded SAD patients as more anxious and less socially skilled than healthy controls. Results indicated oxytocin-induced improvement of observer-rated social behavior in SAD patients compared to placebo but only in the getting acquainted task. This effect was not perceived as such by patients themselves and did not improve their affect ratings. In conclusion, this study found support for the idea that oxytocin helps SAD patients to perform better in social interactions, although this improvement seemed context-dependent (i.e., only present in the getting-acquainted task) and 'not perceived by the patient.",2021,Results indicated oxytocin-induced improvement of observer-rated social behavior in SAD patients compared to placebo but only in the getting acquainted task.,"['social anxiety disorder', 'patients with a social anxiety disorder (SAD', 'SAD patients (N\xa0=\xa040) and healthy controls (N\xa0=\xa039']","['oxytocin', 'placebo', 'hormone oxytocin']","['social behavior and anxious appearance', 'social anxiety', 'observer-rated social behavior']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]","[{'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]",40.0,0.0309259,Results indicated oxytocin-induced improvement of observer-rated social behavior in SAD patients compared to placebo but only in the getting acquainted task.,"[{'ForeName': 'Marisol J', 'Initials': 'MJ', 'LastName': 'Voncken', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands. Electronic address: m.voncken@maastrichtuniversity.nl.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Dijk', 'Affiliation': 'Programme group Clinical Psychology, Faculty of Social and Behavioural Sciences, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Stöhr', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Isabella J M', 'Initials': 'IJM', 'LastName': 'Niesten', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Schruers', 'Affiliation': 'Research Institute Mental Health and Neuroscience, Maastricht University, Maastricht, the Netherlands; Faculty of Psychology, Center for Experimental and Learning Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Kim P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2021.07.005']
1063,34358777,"Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial.","BACKGROUND


Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).
METHODS


In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m 2 , oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration.
RESULTS


The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1-20.6) in arm DE and 27.8% (95% CI 22.8-39.4) in arm D (chi-squared test 10.01; P = 0.002). The most frequent grade III-IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).
CONCLUSIONS


The combination of enzalutamide and docetaxel appears to be more clinically beneficial than docetaxel alone in previously untreated mCRPC patients, although serious adverse events were more frequent. Our findings suggest that first-line treatment with this combination could lead to an additional clinical benefit when prompt and prolonged disease control is simultaneously required. Clearly, these results should be considered cautiously because of the study's phase II design and the absence of an overall survival benefit.
TRIAL REGISTRATION NUMBERS


EudraCT 2014-000175-43 - NCT02453009.",2021,"The most frequent grade III-IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).
","['patients with metastatic castration-resistant prostate cancer', 'metastatic castration-resistant prostate cancer (mCRPC', '246 eligible patients', 'previously untreated mCRPC patients']","['docetaxel 75\xa0mg/m 2 , oral prednisone 5\xa0mg twice daily and oral enzalutamide 160\xa0mg', 'Docetaxel and prednisone with or without enzalutamide', 'docetaxel and enzalutamide', 'enzalutamide and docetaxel', 'docetaxel, prednisone and enzalutamide (n\xa0=\xa0120) or docetaxel and prednisone']","['percentage of patients without investigator-assessed disease progression', 'febrile neutropenia', 'neutropenia', '6-month progression rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533720', 'cui_str': 'Prednisone 5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.133146,"The most frequent grade III-IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%).
","[{'ForeName': 'Orazio', 'Initials': 'O', 'LastName': 'Caffo', 'Affiliation': 'Medical Oncology Department, Santa Chiara Hospital, Trento, Italy. Electronic address: orazio.caffo@apss.tn.it.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Ortega', 'Affiliation': 'Department of Oncology, University of Turin Candiolo Cancer Institute - FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Nolè', 'Affiliation': 'Division of Urogenital and Head and Neck Tumours Medical Treatment, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Donatello', 'Initials': 'D', 'LastName': 'Gasparro', 'Affiliation': 'Medical Oncology Unit, Department of General & Specialistic Medicine, University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mucciarini', 'Affiliation': 'Medical Oncology Unit, Ramazzini Hospital, Carpi, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Department of Onco-Hematology, Division of Medical Oncology, IRCCS Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Department of Oncology, Oncology 1, Veneto Institute of Oncology - IRCCS, Padua, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Iacovelli', 'Affiliation': 'Department of Medical Oncology, Azienda Ospedaliera Universitaria Integrata (AOUI), Verona, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura de Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Facchini', 'Affiliation': 'Departmental Unit of Clinical and Experimental Uro-Andrologic Oncology, Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Veccia', 'Affiliation': 'Medical Oncology Department, Santa Chiara Hospital, Trento, Italy.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Palesandro', 'Affiliation': 'Department of Oncology, University of Turin Candiolo Cancer Institute - FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Verri', 'Affiliation': 'Division of Urogenital and Head and Neck Tumours Medical Treatment, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Buti', 'Affiliation': 'Medical Oncology Unit, Department of General & Specialistic Medicine, University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Razzini', 'Affiliation': 'Medical Oncology Unit, Ramazzini Hospital, Carpi, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Bozza', 'Affiliation': 'Department of Onco-Hematology, Division of Medical Oncology, IRCCS Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Maruzzo', 'Affiliation': 'Department of Oncology, Oncology 1, Veneto Institute of Oncology - IRCCS, Padua, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ciccarese', 'Affiliation': 'Department of Medical Oncology, Azienda Ospedaliera Universitaria Integrata (AOUI), Verona, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Schepisi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura de Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Rossetti', 'Affiliation': 'Departmental Unit of Clinical and Experimental Uro-Andrologic Oncology, Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Maines', 'Affiliation': 'Medical Oncology Department, Santa Chiara Hospital, Trento, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Kinspergher', 'Affiliation': 'Medical Oncology Department, Santa Chiara Hospital, Trento, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Fratino', 'Affiliation': 'Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Ermacora', 'Affiliation': 'Department of Oncology, Presidio Ospedaliero Universitario Santa Maria della Misericordia, Azienda Sanitaria Universitaria Integrata Friuli Centrale, Udine, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Nicodemo', 'Affiliation': 'Oncology Unit, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar di Valpolicella, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Giordano', 'Affiliation': ""Department of Medical Oncology, ASST Lariana, Ospedale Sant'Anna, San Fermo della Battaglia (CO), Italy.""}, {'ForeName': 'Donata', 'Initials': 'D', 'LastName': 'Sartori', 'Affiliation': 'Oncology Unit, AULSS 3, Mirano, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Scapoli', 'Affiliation': 'Division of Clinical Oncology, S. Anna University Hospital, Ferrara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sabbatini', 'Affiliation': 'Department of Oncology, Hematology & Respiratory Diseases, Division of Oncology, University of Modena & Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lo Re', 'Affiliation': 'Medical Oncology Department, Santa Maria degli Angeli Hospital, Pordenone, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Morelli', 'Affiliation': 'Medical Oncology Department, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': ""D'Angelo"", 'Affiliation': 'Department of Medical Oncology, San Vincenzo Hospital, Taormina, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Vittimberga', 'Affiliation': 'Dipartimento Oncologico, Ospedale Alessandro Manzoni, ASST Lecco, Lecco, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Lippe', 'Affiliation': 'Operative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carrozza', 'Affiliation': 'Oncology Unit, Ospedale ""degli Infermi"", AUSL Romagna, Faenza, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Messina', 'Affiliation': 'Department\u2009of Medical Oncology, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Galli', 'Affiliation': 'Department of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Valcamonico', 'Affiliation': 'Unit of Medical Oncology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, ASST Spedali Civili of Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pappagallo', 'Affiliation': 'Clinical Epidemiologist, Silea, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Aglietta', 'Affiliation': 'Department of Oncology, University of Turin Candiolo Cancer Institute - FPO-IRCCS, Candiolo, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.06.016']
1064,34365645,The effect of autonomous and controlled motivation on self-control performance and the acute cortisol response.,"Autonomously regulated self-control typically does not reduce over time as much, compared with self-control underpinned by controlled motivation. The proposed study tested whether an acute stress response is implicated in this process. Utilizing a framework grounded in self-determination theory, this study examined whether participants' motivational regulation would influence repeated self-control performance and acute stress levels, measured by the stress hormone cortisol. A single-blind randomized experimental design incorporating two motivational conditions (autonomous regulation and controlled regulation) tested these hypotheses. Participants (female = 28; male = 11; M age   = 22.33) performed three sequential self-control tasks; a modified Stroop task followed by two ""wall sit"" postural persistence tasks. Salivary cortisol was measured at baseline and after each of the wall sits. A repeated measures ANCOVA unexpectedly revealed that participants in the controlled regulation condition recorded greater wall sit performance in the first and second wall sits, compared with the autonomous condition. A repeated measures ANCOVA also revealed a significant quadratic interaction for cortisol. Controlled regulation was associated with an increase, and autonomous regulation condition a decrease, in cortisol that subsided at timepoint two. Results imply autonomous motivation facilitates an adaptive stress response. Performance on the self-control tasks was contrary to expectations, but may reflect short-term performance benefits of controlled motivation.",2021,"A repeated measures ANCOVA unexpectedly revealed that participants in the controlled regulation condition recorded greater wall sit performance in the first and second wall sits, compared with the autonomous condition.",['Participants (female\xa0=\xa028; male\xa0=\xa011; M age  \xa0=\xa022.33) performed three'],"['sequential self-control tasks; a modified Stroop task followed by two ""wall sit"" postural persistence tasks']","['adaptive stress response', 'wall sit performance', 'Salivary cortisol', 'acute cortisol response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",28.0,0.0487492,"A repeated measures ANCOVA unexpectedly revealed that participants in the controlled regulation condition recorded greater wall sit performance in the first and second wall sits, compared with the autonomous condition.","[{'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Steel', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Nicolette C', 'Initials': 'NC', 'LastName': 'Bishop', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Taylor', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}]",Psychophysiology,['10.1111/psyp.13915']
1065,34374961,Sex-Specific Pharmacotherapy for Back Pain: A Proof-of-Concept Randomized Trial.,"BACKGROUND


Preventing transition to chronic back pain (CBP) is a long-sought strategy that could rescue patients from prolonged suffering. Recent rodent and human brain imaging studies suggest involvement of sexually dimorphic, dopaminergic-motivational, mesolimbic circuits in the transition to chronic pain (tCBP), and hint that the combination of carbidopa/levodopa and naproxen (LDP + NPX) may block tCBP. Here we evaluated, in people with recent-onset back pain, whether a 3-month treatment with LDP + NPX is safe, blocks tCBP, and whether its efficacy is sex-dependent.
METHODS


A total of 72 participants were enrolled and stratified by risk for tCBP using brain-imaging biomarkers. Low-risk participants entered a no-treatment arm. Others were randomized to placebo + naproxen or LDP + NPX for 3 months.
RESULTS


Both treatments resulted in more than 50% pain relief for approximately 75% of participants. A strong sex by treatment interaction was observed for daily pain intensity (phone NRS, P = 0.007), replicated on 4-week average pain (Pain/4w, P = 0.00001), and in intent-to-treat analysis (Pain/4w, P = 0.000004). Nucleus accumbens functional connectivity with medial prefrontal cortex, a predefined objective biomarker, showed sex dependence at baseline (P = 0.03) and sex-by-treatment interaction effect 3 months after treatment cessation (P = 0.031). Treatment modified the psychological profile of participants, and disrupted brain modeling-based predicted back pain intensity trajectories. Forty participants were queried 3.3 years from trial start; back pain ratings were similar between end of treatment and at 3.3 years (P = 0.62), indicating persistence of relief for this duration.
CONCLUSIONS


These results provide the first evidence for preventing transition to chronic back pain using sex-specific pharmacotherapy. These provocative observations require confirmation in a larger study. ClinicalTrials.gov identifier: NCT01951105.",2021,"A strong sex by treatment interaction was observed for daily pain intensity (phone NRS, P = 0.007), replicated on 4-week average pain (Pain/4w, P = 0.00001), and in intent-to-treat analysis (Pain/4w, P = 0.000004).","['people with recent-onset back pain', '72 participants were enrolled and stratified by risk for tCBP using brain-imaging biomarkers', 'Back Pain']","['placebo\u2009+\u2009naproxen or LDP\u2009+\u2009NPX', 'carbidopa/levodopa and naproxen (LDP\u2009+\u2009NPX', 'LDP\u2009+\u2009NPX']","['pain relief', 'daily pain intensity', 'pain ratings', '4-week average pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439230', 'cui_str': 'week'}]",72.0,0.370715,"A strong sex by treatment interaction was observed for daily pain intensity (phone NRS, P = 0.007), replicated on 4-week average pain (Pain/4w, P = 0.00001), and in intent-to-treat analysis (Pain/4w, P = 0.000004).","[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Reckziegel', 'Affiliation': 'Center for Chronic Pain and Drug Abuse, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tétreault', 'Affiliation': 'Department of Physiology, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Ghantous', 'Affiliation': 'Department of Physiology, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Wakaizumi', 'Affiliation': 'Center for Chronic Pain and Drug Abuse, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Petre', 'Affiliation': 'Department of Physiology, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Lejian', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Center for Chronic Pain and Drug Abuse, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Jabakhanji', 'Affiliation': 'Center for Chronic Pain and Drug Abuse, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Abdullah', 'Affiliation': 'Department of Physiology, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Vachon-Presseau', 'Affiliation': 'Department of Physiology, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Berger', 'Affiliation': 'Department of Physiology, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Baria', 'Affiliation': 'Department of Physiology, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Griffith', 'Affiliation': 'Center for Chronic Pain and Drug Abuse, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Marwan N', 'Initials': 'MN', 'LastName': 'Baliki', 'Affiliation': 'Center for Chronic Pain and Drug Abuse, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Schnitzer', 'Affiliation': 'Center for Chronic Pain and Drug Abuse, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'A Vania', 'Initials': 'AV', 'LastName': 'Apkarian', 'Affiliation': 'Center for Chronic Pain and Drug Abuse, Northwestern University Feinberg School of Medicine, Chicago, USA. a-apkarian@northwestern.edu.'}]",Pain and therapy,['10.1007/s40122-021-00297-2']
1066,34374960,Comparison of Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) and Laparoendoscopic Single-Site (LESS) Hysterectomy on Postoperative Pain Reduction: A Randomized Pilot Study.,"INTRODUCTION


Vaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy has shown benefit in postoperative pain and operation time compared to laparoscopic hysterectomy in recent studies. However, no prospective studies comparing laparoendoscopic single-site (LESS) and vNOTES hysterectomy have been performed. This study aims to evaluate postoperative pain and safety of vNOTES hysterectomy compared to LESS hysterectomy for benign uterine disease.
METHODS


This study is a prospective, investigator-initiated randomized controlled pilot trial. A total of 26 patients were randomized and allocated to vNOTES group (n = 13) and LESS group (n = 13). The primary outcome was postoperative abdominal and vaginal pain evaluated 24 h after surgery. Secondary outcomes included the number of additional analgesics administered and the maintenance rate of patient-controlled analgesia (PCA).
RESULTS


No differences were shown in baseline characteristics between the two groups. Operation time was longer in the LESS group (median, 55 vs. 75 min; P = 0.027), and there were no differences in estimated blood loss, postoperative hemoglobin level, surgical indications, and hospitalization days. Postoperative abdominal pain intensity did not differ between the two groups, while the vNOTES group showed higher postoperative vaginal pain than the LESS group at 16 and 24 h after surgery (median, 3 vs. 1 and 2 vs. 0, P = 0.007 and P = 0.010, at 16 and 24 h respectively). No differences were shown in the number of additional analgesics and PCA use between the two groups.
CONCLUSIONS


vNOTES hysterectomy can be safely performed for benign uterine disease requiring hysterectomy. However, vNOTES hysterectomy might be associated with higher postoperative vaginal pain intensity compared to LESS hysterectomy.
TRIAL REGISTRATION


CRIS identifier KCT0004605.",2021,"Operation time was longer in the LESS group (median, 55 vs. 75 min; P = 0.027), and there were no differences in estimated blood loss, postoperative hemoglobin level, surgical indications, and hospitalization days.","['26 patients', 'benign uterine disease requiring hysterectomy']","['LESS hysterectomy', 'Hysterectomy', 'LESS', 'vNOTES hysterectomy', 'Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) and Laparoendoscopic Single-Site (LESS', 'laparoendoscopic single-site (LESS) and vNOTES hysterectomy', 'Vaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy', 'laparoscopic hysterectomy']","['Pain Reduction', 'number of additional analgesics administered and the maintenance rate of patient-controlled analgesia (PCA', 'Operation time', 'Postoperative', 'postoperative pain and safety', 'estimated blood loss, postoperative hemoglobin level, surgical indications, and hospitalization days', 'postoperative abdominal and vaginal pain evaluated 24\xa0h after surgery', 'postoperative vaginal pain', 'number of additional analgesics and PCA', 'Postoperative abdominal pain intensity', 'postoperative vaginal pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0042131', 'cui_str': 'Disorder of uterus'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C2936208', 'cui_str': 'Natural Orifice Transluminal Endoscopic Surgery'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0236082', 'cui_str': 'Vaginal pain'}, {'cui': 'C4047372', 'cui_str': 'Postoperative abdominal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",26.0,0.137058,"Operation time was longer in the LESS group (median, 55 vs. 75 min; P = 0.027), and there were no differences in estimated blood loss, postoperative hemoglobin level, surgical indications, and hospitalization days.","[{'ForeName': 'Soo Jin', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-Ro Jongno-Gu, 110-744, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Hee Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-Ro Jongno-Gu, 110-744, Seoul, 03080, Republic of Korea. bboddi0311@gmail.com.'}, {'ForeName': 'Ga Won', 'Initials': 'GW', 'LastName': 'Yim', 'Affiliation': 'Department of Obstetrics and Gynecology, Dongguk University College of Medicine, 27 Dongguk-ro, Ilsandong-gu, Goyang, Gyeonggi, 10326, Republic of Korea. gawonyim@gmail.com.'}]",Pain and therapy,['10.1007/s40122-021-00300-w']
1067,34374952,Clinical and Microbiological Outcomes of Ceftazidime-Avibactam Treatment in Adults with Gram-Negative Bacteremia: A Subset Analysis from the Phase 3 Clinical Trial Program.,"INTRODUCTION


This exploratory analysis assessed efficacy and safety outcomes in patients with Gram-negative bacteremia treated with ceftazidime-avibactam or comparator across five phase 3, randomized, controlled, multi-center trials in adults with complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI)/pyelonephritis, hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP).
METHODS


In each trial, RECLAIM and RECLAIM 3 (cIAI; NCT01499290/NCT01726023), REPRISE (cIAI/cUTI; NCT01644643), RECAPTURE (cUTI; NCT01595438/NCT01599806), and REPROVE (HAP/VAP; NCT01808092), patients were randomized 1:1 to intravenous ceftazidime-avibactam (plus metronidazole for those with cIAI) or comparators (carbapenems in > 97% patients) for 5-21 days. Efficacy assessments included clinical and microbiological responses at the test-of-cure visit in the pooled Gram-negative extended microbiologically evaluable (GNeME) population (bacteremia subset). Safety outcomes were summarized for patients with positive bacterial blood culture(s) at baseline who received ≥ 1 dose of study treatment.
RESULTS


The overall safety population included 4050 patients (ceftazidime-avibactam, n = 2024; comparator, n = 2026). The GNeME population (bacteremia subset) comprised 101 patients (ceftazidime-avibactam, n = 54; comparator, n = 47). Clinical cure rates (all indications combined) were 47/54 (87.0%) for ceftazidime-avibactam and 39/47 (83.0%) for comparators; favorable microbiological response rates were 43/54 (79.6%) and 32/47 (68.1%), respectively. Clinical and microbiological responses in the bacteremia subset were generally similar to those in the overall set. The pattern of adverse events in patients with bacteremia was similar between treatment groups and was consistent with the known safety profile of ceftazidime-avibactam.
CONCLUSION


This analysis provides supportive evidence of the efficacy and safety of ceftazidime-avibactam in patients with Gram-negative bacteremia associated with cIAI, cUTI/pyelonephritis, or HAP/VAP.",2021,"Clinical cure rates (all indications combined) were 47/54 (87.0%) for ceftazidime-avibactam and 39/47 (83.0%) for comparators; favorable microbiological response rates were 43/54 (79.6%) and 32/47 (68.1%), respectively.","['patients with Gram-negative bacteremia associated with cIAI, cUTI/pyelonephritis, or HAP/VAP', 'Adults with Gram-Negative Bacteremia', 'patients with positive bacterial blood culture(s) at baseline who received\u2009≥\u20091 dose of study treatment', 'adults with complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI)/pyelonephritis, hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP', '101 patients (ceftazidime-avibactam, n\u2009=\u200954; comparator, n\u2009=\u200947', '4050\xa0patients (ceftazidime-avibactam, n\u2009=\u20092024; comparator, n\u2009=\u20092026', 'patients with Gram-negative bacteremia treated with']","['Ceftazidime-Avibactam Treatment', 'ceftazidime-avibactam', 'ceftazidime-avibactam or comparator', 'ceftazidime-avibactam (plus metronidazole']","['Clinical and microbiological responses', 'microbiological response rates', 'efficacy and safety outcomes', 'Clinical cure rates', 'clinical and microbiological responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0744471', 'cui_str': 'Gram-negative bacteremia'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4524048', 'cui_str': 'Complicated intra-abdominal infection'}, {'cui': 'C4552431', 'cui_str': 'Complicated urinary tract infection'}, {'cui': 'C0034186', 'cui_str': 'Pyelonephritis'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C3656596', 'cui_str': 'Avibactam and ceftazidime'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C3656596', 'cui_str': 'Avibactam and ceftazidime'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.153307,"Clinical cure rates (all indications combined) were 47/54 (87.0%) for ceftazidime-avibactam and 39/47 (83.0%) for comparators; favorable microbiological response rates were 43/54 (79.6%) and 32/47 (68.1%), respectively.","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Mazuski', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Wagenlehner', 'Affiliation': 'Department of Urology, Pediatric Urology and Andrology, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Torres', 'Affiliation': 'Department of Pulmonology, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERES, ICREA, Barcelona, Spain.'}, {'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Carmeli', 'Affiliation': 'Division of Epidemiology, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Chow', 'Affiliation': 'Global Product Development, Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Wajsbrot', 'Affiliation': 'Biostatistics, Pfizer, New York, NY, USA.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Stone', 'Affiliation': 'Microbiology, Internal Medicine, Pfizer, Groton, CT, USA.'}, {'ForeName': 'Paurus', 'Initials': 'P', 'LastName': 'Irani', 'Affiliation': 'Global Medical Affairs, Pfizer, Tadworth, Surrey, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bharucha', 'Affiliation': 'Clinical Development, AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'Safety Surveillance and Risk Management, Pfizer, Sandwich, Kent, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tawadrous', 'Affiliation': 'Global Product Development, Pfizer, Inc, 445 Eastern Point Road, Groton, CT, 06340, USA. Margaret.Tawadrous@pfizer.com.'}]",Infectious diseases and therapy,['10.1007/s40121-021-00506-7']
1068,34371442,"Maintenance versus discontinuation of androgen deprivation therapy during continuous or intermittent docetaxel administration in castration-resistant prostate cancer patients: A multicentre, randomised Phase III study by the Piemonte Oncology Network.","BACKGROUND


This study was designed to demonstrate the non-inferiority (NI) in overall survival (OS) of suspension of androgen deprivation therapy (ADT) versus maintenance and intermittent versus continuous docetaxel administration in metastatic castration-resistant prostate cancer (mCRPC) patients.
PATIENTS AND METHODS


mCRPC patients were randomised to first-line docetaxel with maintenance or suspension of ADT. Patients attaining a prostate-specific antigen (PSA) response after four chemotherapy cycles underwent second randomisation to receive continuous or intermittent docetaxel therapy. Six hundred patients were to be randomised to achieve 80% statistical power to demonstrate an NI hazard ratio (HR) of 1.25 of interruption versus maintenance of ADT.
RESULTS


The trial was prematurely closed when 198 participants were randomised. OS was similar in patients who continued (N = 96) versus those who interrupted (n = 102) ADT during docetaxel therapy (HR 0.98, 95% confidence interval [CI] 0.72-1.33] and those on a continuous (N = 35) versus an intermittent (N = 42) docetaxel schedule (HR 0.86, 95% CI 0.55-1.43). No difference in radiological progression-free survival, PSA response, or toxicity was observed between the study arms. The actual NI hazard margins of OS in Arms A and B patients were 1.33 and 1.43, respectively.
CONCLUSIONS


This trial enrolled one-third of the planned patients; this main weakness dramatically limits the interpretation of the results. ADT discontinuation and switching to an intermittent schedule did not seem to affect docetaxel efficacy. The absence of testosterone recovery in the majority of patients could have been a contributory factor. In men with mCRPC, ADT discontinuation should only be done with regular biochemical and clinical monitoring, with the option of quickly restarting ADT at disease progression.",2021,"OS was similar in patients who continued (N = 96) versus those who interrupted (n = 102) ADT during docetaxel therapy (HR 0.98, 95% confidence interval [CI] 0.72-1.33] and those on a continuous (N = 35) versus an intermittent (N = 42) docetaxel schedule (HR 0.86, 95% CI 0.55-1.43).","['Six hundred patients', 'Patients attaining a prostate-specific antigen (PSA) response after four chemotherapy cycles underwent second randomisation to receive', '198 participants were randomised', 'metastatic castration-resistant prostate cancer (mCRPC) patients', 'mCRPC patients', 'castration-resistant prostate cancer patients']","['androgen deprivation therapy (ADT) versus maintenance and intermittent versus continuous docetaxel', 'docetaxel with maintenance or suspension of ADT', 'continuous or intermittent docetaxel therapy', 'androgen deprivation therapy', 'docetaxel administration']","['radiological progression-free survival, PSA response, or toxicity', 'docetaxel efficacy', 'OS']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",600.0,0.169857,"OS was similar in patients who continued (N = 96) versus those who interrupted (n = 102) ADT during docetaxel therapy (HR 0.98, 95% confidence interval [CI] 0.72-1.33] and those on a continuous (N = 35) versus an intermittent (N = 42) docetaxel schedule (HR 0.86, 95% CI 0.55-1.43).","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Bianchi', 'Affiliation': 'Medical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST-Spedali Civili, Piazzale Spedali Civili 1, 25123, Brescia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Mosca', 'Affiliation': 'Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Dalla Volta', 'Affiliation': 'Medical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST-Spedali Civili, Piazzale Spedali Civili 1, 25123, Brescia, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Prati', 'Affiliation': 'Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy; Department of Medical Oncology, Ospedale S. Lazzaro Azienda Sanitaria Locale CN2, Alba-Bra, Cuneo, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Ortega', 'Affiliation': 'Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy; Department of Medical Oncology, Ospedale S. Lazzaro Azienda Sanitaria Locale CN2, Alba-Bra, Cuneo, Italy.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Buttigliero', 'Affiliation': 'Department of Medical Oncology, University of Torino, San Luigi Gonzaga Hospital, Orbassano, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fea', 'Affiliation': 'Department of Medical Oncology, S Croce and Carle Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vanella', 'Affiliation': 'Department of Medical Oncology, S Croce and Carle Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Valcamonico', 'Affiliation': 'Medical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST-Spedali Civili, Piazzale Spedali Civili 1, 25123, Brescia, Italy.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Zamparini', 'Affiliation': 'Medical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST-Spedali Civili, Piazzale Spedali Civili 1, 25123, Brescia, Italy.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Sirotova', 'Affiliation': 'Unit of Medical Oncology, Aosta Regional Hospital, Aosta, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Chiappino', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero Universitaria Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Orietta', 'Initials': 'O', 'LastName': 'Dal Canton', 'Affiliation': 'Medical Oncology Unit, Humanitas Gradenigo Hospital, Turin, Italy; Department of Medical Oncology, Azienda Sanitaria Locale Città di Torino, Turin, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Masini', 'Affiliation': 'Medical Oncology Unit, Clinical Cancer Center, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Sacco', 'Affiliation': 'Department of Oncology, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Amoroso', 'Affiliation': 'Medical Oncology Unit, Azienda USL Toscana Nord-Ovest, Ospedale Versilia, Lido di Camaiore, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Montagnani', 'Affiliation': 'Medical Oncology Unit, Azienda Sanitaria Locale Biella, Biella, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Comandone', 'Affiliation': 'Medical Oncology Unit, Humanitas Gradenigo Hospital, Turin, Italy; Department of Medical Oncology, Azienda Sanitaria Locale Città di Torino, Turin, Italy.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Bellissimo', 'Affiliation': 'Unit of Clinical Epidemiology, Azienda Ospedaliero Universitaria Città Della Salute e Della Scienza di Torino and Centro di Prevenzione Oncologica Piemonte, Torino, Italy.'}, {'ForeName': 'Giovannino', 'Initials': 'G', 'LastName': 'Ciccone', 'Affiliation': 'Unit of Clinical Epidemiology, Azienda Ospedaliero Universitaria Città Della Salute e Della Scienza di Torino and Centro di Prevenzione Oncologica Piemonte, Torino, Italy.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Baier', 'Affiliation': 'Medical Oncology Unit, Ospedale Centrale di Bolzano, 39100 Bolzano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Gennari', 'Affiliation': 'Division of Oncology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tucci', 'Affiliation': 'Department of Medical Oncology, Cardinal Massaia Hospital, Asti, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Berruti', 'Affiliation': 'Medical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST-Spedali Civili, Piazzale Spedali Civili 1, 25123, Brescia, Italy. Electronic address: alfredo.berruti@unibs.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.06.034']
1069,34375789,No evidence for clinical efficacy of adjunctive celecoxib with vortioxetine in the treatment of depression: A 6-week double-blind placebo controlled randomized trial.,"Given the role of low-grade inflammation in the pathophysiology of major depressive disorder (MDD), anti-inflammatory strategies may improve treatment outcomes in some patients. However, it is controversial whether they can be used as adjunctive treatments and whether pre-treatment levels of inflammation can predict treatment outcomes. This study was conducted to measure the efficacy of anti-inflammatory augmentation of antidepressant treatment in MDD patients; and to investigate whether treatment response was dependent on baseline inflammation levels. This parallel-group randomised, double-blind, placebo-controlled trial was conducted at the University of Adelaide (Australia). Participants with MDD were randomised to receive vortioxetine with celecoxib or vortioxetine with placebo for six weeks, and baseline blood high sensitivity C reactive protein levels were measured. Primary outcome was change in depressive symptoms (Montgomery-Åsberg Depression Rating Scale) and secondary outcomes included change in cognition (THINC-integrated tool - Codebreaker task) and functioning (Functioning Assessment Short Test) over 6 weeks. There was no evidence of superior efficacy of celecoxib augmentation over placebo on depressive symptom severity, response and remission rates, cognition and psychosocial functioning. There was also no evidence that pre-treatment inflammation levels modified the effect of celecoxib augmentation versus placebo. This observed lack of efficacy of celecoxib add-on does not support the use of celecoxib augmentation of antidepressants in the treatment of MDD in a cohort that mostly comprises treatment-resistant individuals. Additionally, C-reactive protein may not be suitable to predict treatment selection and response in MDD. The study was registered on the Australian New Zealand Clinical Trials Registry: ACTRN12617000527369 (www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000527369p).",2021,"There was no evidence of superior efficacy of celecoxib augmentation over placebo on depressive symptom severity, response and remission rates, cognition and psychosocial functioning.","['Australian New Zealand Clinical Trials Registry', 'Participants with MDD', 'MDD patients', 'depression', 'University of Adelaide (Australia']","['adjunctive celecoxib', 'vortioxetine', 'vortioxetine with celecoxib or vortioxetine with placebo', 'celecoxib', 'placebo']","['change in depressive symptoms (Montgomery-Åsberg Depression Rating Scale) and secondary outcomes included change in cognition (THINC-integrated tool - Codebreaker task) and functioning (Functioning Assessment Short Test', 'depressive symptom severity, response and remission rates, cognition and psychosocial functioning']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.560348,"There was no evidence of superior efficacy of celecoxib augmentation over placebo on depressive symptom severity, response and remission rates, cognition and psychosocial functioning.","[{'ForeName': 'Bernhard T', 'Initials': 'BT', 'LastName': 'Baune', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia; Department of Psychiatry, Melbourne Medical School, The University of Melbourne, Melbourne, Australia; The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Parkville, Australia; Department of Psychiatry and Psychotherapy, University Hospital Münster, University of Münster, Münster, Germany. Electronic address: bernhard.baune@ukmuenster.de.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sampson', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Louise', 'Affiliation': ""'Faculty of Health Sciences, University of Adelaide, Adelaide, Australia.""}, {'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Hori', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'K Oliver', 'Initials': 'KO', 'LastName': 'Schubert', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia; Northern Adelaide Mental Health Service, Salisbury, Australia.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Clark', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Natalie T', 'Initials': 'NT', 'LastName': 'Mills', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Célia', 'Initials': 'C', 'LastName': 'Fourrier', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia; Lysosomal Health in Ageing, Hopwood Centre for Neurobiology, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2021.07.092']
1070,34375749,Sense2Stop: A micro-randomized trial using wearable sensors to optimize a just-in-time-adaptive stress management intervention for smoking relapse prevention.,"BACKGROUND


Relapse to smoking is commonly triggered by stress, but behavioral interventions have shown only modest efficacy in preventing stress-related relapse. Continuous digital sensing to detect states of smoking risk and intervention receptivity may make it feasible to increase treatment efficacy by adapting intervention timing.
OBJECTIVE


Aims are to investigate whether the delivery of a prompt to perform stress management behavior, as compared to no prompt, reduces the likelihood of (a) being stressed and (b) smoking in the subsequent two hours, and (c) whether current stress moderates these effects.
STUDY DESIGN


A micro-randomized trial will be implemented with 75 adult smokers who wear Autosense chest and wrist sensors and use the mCerebrum suite of smartphone apps to report and respond to ecological momentary assessment (EMA) questions about smoking and mood for 4 days before and 10 days after a quit attempt and to access a set of stress-management apps. Sensor data will be processed on the smartphone in real time using the cStress algorithm to classify minutes as probably stressed or probably not stressed. Stressed and non-stressed minutes will be micro-randomized to deliver either a prompt to perform a stress management exercise via one of the apps or no prompt (2.5-3 stress management prompts will be delivered daily). Sensor and self-report assessments of stress and smoking will be analyzed to optimize decision rules for a just-in-time adaptive intervention (JITAI) to prevent smoking relapse.
SIGNIFICANCE


Sense2Stop will be the first digital trial using wearable sensors and micro-randomization to optimize a just-in-time adaptive stress management intervention for smoking relapse prevention.",2021,Stressed and non-stressed minutes will be micro-randomized to deliver either a prompt to perform a stress management exercise via one of the apps or no prompt (2.5-3 stress management prompts will be delivered daily).,['75 adult smokers who wear Autosense chest and wrist sensors and use the mCerebrum suite of smartphone apps to report and respond to ecological momentary assessment (EMA) questions about smoking and mood for 4\u202fdays before and 10\u202fdays after a quit attempt and to access a set of stress-management apps'],"['wearable sensors to optimize a just-in-time-adaptive stress management intervention', 'Sense2Stop']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],75.0,0.0207162,Stressed and non-stressed minutes will be micro-randomized to deliver either a prompt to perform a stress management exercise via one of the apps or no prompt (2.5-3 stress management prompts will be delivered daily).,"[{'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Battalio', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, 680 N. Lakeshore Drive, Suite 1400, Chicago, IL 60611, United States of America.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Conroy', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, 680 N. Lakeshore Drive, Suite 1400, Chicago, IL 60611, United States of America; Department of Kinesiology, Penn State University, 266 Recreation Building, University Park, PA 16802, United States of America.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Dempsey', 'Affiliation': 'Survey Research Center, University of Michigan, 426 Thompson Street, Room 2464, Ann Arbor, MI 48106, United States of America.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liao', 'Affiliation': 'Department of Statistics, Harvard University, Science Center 400 Suite, One Oxford Street, Cambridge, MA 02138, United States of America.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Menictas', 'Affiliation': 'Department of Statistics, Harvard University, Science Center 400 Suite, One Oxford Street, Cambridge, MA 02138, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Department of Statistics, Harvard University, Science Center 400 Suite, One Oxford Street, Cambridge, MA 02138, United States of America.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Survey Research Center, University of Michigan, 426 Thompson Street, Room 2464, Ann Arbor, MI 48106, United States of America.'}, {'ForeName': 'Tianchen', 'Initials': 'T', 'LastName': 'Qian', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA 92697, United States of America.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Computer Science, University of Memphis, 319 Dunn Hall, Memphis, TN 38152, United States of America.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, 680 N. Lakeshore Drive, Suite 1400, Chicago, IL 60611, United States of America. Electronic address: bspring@northwestern.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106534']
1071,34375748,Multilevel Follow-up of Cancer Screening (mFOCUS): Protocol for a multilevel intervention to improve the follow-up of abnormal cancer screening test results.,"INTRODUCTION


While substantial attention is focused on the delivery of routine preventive cancer screening, less attention has been paid to systematically ensuring that there is timely follow-up of abnormal screening test results. Barriers to completion of timely follow-up occur at the patient, provider, care team and system levels.
METHODS


In this pragmatic cluster randomized controlled trial, primary care sites in three networks are randomized to one of four arms: (1) standard care, (2) ""visit-based"" reminders that appear in a patient's electronic health record (EHR) when it is accessed by either patient or providers (3) visit based reminders with population health outreach, and (4) visit based reminders, population health outreach, and patient navigation with systematic screening and referral to address social barriers to care. Eligible patients in participating practices are those overdue for follow-up of an abnormal results on breast, cervical, colorectal and lung cancer screening tests.
RESULTS


The primary outcome is whether an individual receives follow-up, specific to the organ type and screening abnormality, within 120 days of becoming eligible for the trial. Secondary outcomes assess the effect of intervention components on the patient and provider experience of obtaining follow-up care and the delivery of the intervention components.
CONCLUSIONS


This trial will provide evidence for the role of a multilevel intervention on improving the follow-up of abnormal cancer screening test results. We will also specifically assess the relative impact of the components of the intervention, compared to standard care.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03979495.",2021,"The primary outcome is whether an individual receives follow-up, specific to the organ type and screening abnormality, within 120 days of becoming eligible for the trial.","['Eligible patients in participating practices are those overdue for follow-up of an abnormal results on breast, cervical, colorectal and lung cancer screening tests']","['standard care, (2) ""visit-based"" reminders that appear in a patient\'s electronic health record (EHR) when it is accessed by either patient or providers (3) visit based reminders with population health outreach, and (4) visit based reminders, population health outreach, and patient navigation with systematic screening and referral to address social barriers to care']","['effect of intervention components on the patient and provider experience of obtaining follow-up care and the delivery of the intervention components', 'individual receives follow-up, specific to the organ type and screening abnormality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0459424', 'cui_str': 'Abnormal result'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3242284', 'cui_str': 'Population Health'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C3899107', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",,0.299859,"The primary outcome is whether an individual receives follow-up, specific to the organ type and screening abnormality, within 120 days of becoming eligible for the trial.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: Jennifer.Haas@mgh.harvard.edu.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Atlas', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Aman', 'Affiliation': 'Information, Technology and Consulting (ITC), Dartmouth College, Lebanon, NH.'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Breslau', 'Affiliation': 'Division of Cancer Prevention and Control, National Cancer Institute, Rockville, MD, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Burdick', 'Affiliation': 'Department of Community and Family Medicine, Dartmouth-Hitchcock Health, Lebanon, NH; The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Hanover, NH, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Carpenter', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Chang', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Tin', 'Initials': 'T', 'LastName': 'Dang', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Diamond', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Feldman', 'Affiliation': ""Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Harris', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Shoshana J', 'Initials': 'SJ', 'LastName': 'Hort', 'Affiliation': 'Department of Medicine, Dartmouth-Hitchcock Health, Lebanon, NH, USA.'}, {'ForeName': 'Molly L', 'Initials': 'ML', 'LastName': 'Housman', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Hanover, NH, USA.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Mecker', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Constance D', 'Initials': 'CD', 'LastName': 'Lehman', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Percac-Lima', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Hanover, NH, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Wint', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Anna N A', 'Initials': 'ANA', 'LastName': 'Tosteson', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Hanover, NH, USA; Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center and Geisel School of Medicine at Dartmouth, Lebanon, NH, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106533']
1072,34378852,"Effects of empagliflozin on erythropoiesis in patients with type 2 diabetes: Data from a randomized, placebo-controlled study.","Sodium-glucose cotransporter-2 (SGLT2) inhibitors have been shown to significantly reduce hospitalization for heart failure (HHF) and cardiovascular (CV) mortality in various CV outcome trials in patients with and without type 2 diabetes mellitus (T2D). SGLT2 inhibition further increased haemoglobin and haematocrit levels by an as yet unknown mechanism, and this increase has been shown to be an independent predictor of the CV benefit of these agents, for example, in the EMPA-REG OUTCOME trial. The present analysis of the EMPA haemodynamic study examined the early and delayed effects of empagliflozin treatment on haemoglobin and haematocrit levels, in addition to measures of erythropoiesis and iron metabolism, to better understand the underlying mechanisms. In this prospective, placebo-controlled, double-blind, randomized, two-arm parallel, interventional and exploratory study, 44 patients with T2D were randomized into two groups and received empagliflozin 10 mg or placebo for a period of 3 months in addition to their concomitant medication. Blood and urine was collected at baseline, on Day 1, on Day 3 and after 3 months of treatment to investigate effects on haematological variables, erythropoietin concentrations and indices of iron stores. Baseline characteristics were comparable in the empagliflozin (n = 20) and placebo (n = 22) group. Empagliflozin led to a significant increase in urinary glucose excretion (baseline: 7.3 ± 22.7 g/24 h; Day 1: 48.4 ± 34.7 g/24 h; P < 0.001) as well as urinary volume (baseline: 1740 ± 601 mL/24 h; Day 1: 2112 ± 837 mL/24 h; P = 0.011) already after 1 day and throughout the 3-month study period, while haematocrit and haemoglobin were only increased after 3 months of treatment (haematocrit: baseline: 40.6% ± 4.6%; Month 3: 42.2% ±  4.8%, P < 0.001; haemoglobin: baseline: 136 ± 19 g/L; Month 3: 142 ± 25 g/L; P = 0.008). In addition, after 3 months, empagliflozin further increased red blood cell count (P < 0.001) and transferrin concentrations (P = 0.063) and there was a trend toward increased erythropoietin levels (P = 0.117), while ferritin (P = 0.017), total iron (P = 0.053) and transferrin saturation levels (P = 0.030) decreased. Interestingly, the increase in urinary glucose excretion significantly correlated with the induction of erythropoietin in empagliflozin-treated patients at the 3-month timepoint (Spearman rho 0.64; P = 0.008). Empagliflozin increased haemoglobin concentrations and haematocrit with a delayed time kinetic, which was most likely attributable to increased erythropoiesis with augmented iron utilization and not haemoconcentration. This might be attributable to reduced tubular glucose reabsorption in response to SGLT2 inhibition, possibly resulting in diminished cellular stress as a mechanism for increased renal erythropoietin secretion.",2021,"In addition, after 3 months, empagliflozin further increased red blood cell count (p < 0.001) and transferrin concentrations (p = 0.063) and a trend toward increased erythropoietin levels (p = 0.117) while ferritin (p = 0.017), total iron (p = 0.053) and transferrin saturation (p = 0.030) decreased.","['patients with and without type 2 diabetes mellitus (T2D', '44 patients with T2D', 'Patients with Type 2 Diabetes - data']","['Sodium-glucose cotransporter-2 (SGLT2) inhibitors', 'empagliflozin', 'empagliflozin 10\xa0mg or placebo', 'placebo', 'Empagliflozin']","['urinary glucose excretion', 'heart failure hospitalization (HHF) and cardiovascular (CV) mortality', 'haemoglobin concentration and hematocrit', 'transferrin concentrations', 'haemoglobin concentrations and hematocrit', 'urinary volume', 'haematological parameters, erythropoietin concentrations and indices of iron stores', 'transferrin saturation', 'erythropoietin levels', 'hematocrit and hemoglobin', 'red blood cell count', 'hemoglobin concentrations and hematocrit', 'total iron']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]",44.0,0.147169,"In addition, after 3 months, empagliflozin further increased red blood cell count (p < 0.001) and transferrin concentrations (p = 0.063) and a trend toward increased erythropoietin levels (p = 0.117) while ferritin (p = 0.017), total iron (p = 0.053) and transferrin saturation (p = 0.030) decreased.","[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Thiele', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Rau', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Niels-Ulrik K', 'Initials': 'NK', 'LastName': 'Hartmann', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Möllmann', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Jankowski', 'Affiliation': 'Institute for Molecular Cardiovascular Research, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III, University Hospital Saarland, Saarland University, Homburg, Germany.'}, {'ForeName': 'András P', 'Initials': 'AP', 'LastName': 'Keszei', 'Affiliation': 'Center for Translational & Clinical Research Aachen (CTC-A), RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lehrke', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14517']
1073,33846516,The effect of resistance training set configuration on strength and muscular performance adaptations in male powerlifters.,"The purpose of this study was to determine the effects of different set configurations on strength and muscular performance adaptations after an 8-week resistance training program. Twenty-four male powerlifters participated in this study and were randomly assigned to one of two resistance training groups: (1) cluster sets (CS: n = 8), (2), traditional sets (TS: n = 8), and a control group (CG: n = 8). All powerlifters were evaluated for thigh and arm circumference, upper and lower body impulsive activities, and 1 repetition maximum (1RM) in the back squat, bench press, and deadlift prior to and after the 8-week training intervention. After training, both the CS and TS groups increased arm and thigh circumferences and decreased body fat. The CS group resulted in greater increases in upper and lower body impulsive activities than the TS group, respectively. In addition, the CS and TS groups indicated similar changes in 1RM bench press, back squat, and deadlift following the 8 weeks training intervention. These results suggest that cluster sets induce adaptive changes that favor impulsive activities in powerlifters.",2021,"The CS group resulted in greater increases in upper and lower body impulsive activities than the TS group, respectively.","['male powerlifters', 'Twenty-four male powerlifters']",['resistance training set configuration'],"['upper and lower body impulsive activities', 'strength and muscular performance adaptations', '1RM bench press, back squat, and deadlift', 'thigh and arm circumference, upper and lower body impulsive activities, and 1 repetition maximum (1RM', 'thigh circumferences and decreased body fat']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",24.0,0.0043638,"The CS group resulted in greater increases in upper and lower body impulsive activities than the TS group, respectively.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Arazi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, P.O. Box 41635-1438, Rasht, Iran. hamidarazi@yahoo.com.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Khoshnoud', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, P.O. Box 41635-1438, Rasht, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Asadi', 'Affiliation': 'Department of Physical Education and Sport Sciences, Payame Noor University, Tehran, Iran.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Tufano', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, Prague, Czechia.'}]",Scientific reports,['10.1038/s41598-021-87372-y']
1074,33846503,Side effects of the metacognitive training for depression compared to a cognitive remediation training in patients with depression.,"Although awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of ""symptoms"" and ""quality"". Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.",2021,Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ).,"['patients with depression', 'people with depression', '84 patients']","['Metacognitive Training', 'metacognitive training', 'D-MCT or cognitive remediation training (MyBrainTraining', 'cognitive remediation training']","['number of side effects', 'Side effects', 'Negative Effects Questionnaire (NEQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",84.0,0.0140205,Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ).,"[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Dietrichkeit', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. m.dietrichkeit@uke.de.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Hagemann-Goebel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Asklepios Clinic North, Hamburg, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Nestoriuc', 'Affiliation': 'Institute of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Scientific reports,['10.1038/s41598-021-87198-8']
1075,34375855,Are manual therapy or booster sessions worthwhile in addition to exercise therapy for knee osteoarthritis: Economic evaluation and 2-year follow-up of a randomized controlled trial.,"BACKGROUND


Exercise therapy is known to be an effective intervention for patients with osteoarthritis, however the evidence is limited as to whether adding manual therapy or booster sessions are cost-effective strategies to extend the duration of benefits.
OBJECTIVE


To investigate the cost-effectiveness, at 2-year follow-up, of adding manual therapy and/or booster sessions to exercise therapy.
DESIGN


2-by-2 factorial randomized controlled trial.
METHODS


Participants with knee osteoarthritis were randomly allocated (1:1:1:1) to: exercise therapy delivered in consecutive sessions within 9 weeks (control group), exercise therapy distributed over 1 year using booster sessions, exercise therapy plus manual therapy delivered within 9 weeks, and exercise therapy plus manual therapy with booster sessions. The primary outcome was incremental cost-effectiveness from health system and societal perspectives interpreted as incremental net monetary benefit (INMB).
RESULTS


Of 75 participants, 66 (88 %) were retained at 1-year and 40 (53 %) at 2-year follow-up. All three interventions were cost-effective from both the health system and societal perspectives (INMBs, at 0.5 × GDP/capita willingness to pay (WTP) threshold: $3278 (95%CI -3244 to 9800) and $3904 (95%CI -2823 to 10,632) respectively for booster sessions; $2941 (95%CI -3686 to 9568) and $2618 (95%CI -4005 to 9241) for manual therapy; $270 (95%CI -6139 to 6679) and $404 (95%CI -6097 to 6905) for manual therapy with booster sessions).
CONCLUSION


Manual therapy or booster sessions in addition to exercise therapy are cost-effective at 2-year follow-up. The evidence did not support combining both booster sessions and manual therapy in addition to exercise therapy.",2021,"All three interventions were cost-effective from both the health system and societal perspectives (INMBs, at 0.5 × GDP/capita willingness to pay (WTP) threshold: $3278 (95%CI -3244 to 9800) and $3904 (95%CI -2823 to 10,632) respectively for booster sessions; $2941 (95%CI -3686 to 9568) and $2618 (95%CI -4005 to 9241) for manual therapy; $270 (95%CI -6139 to 6679) and $404 (95%CI -6097 to 6905) for manual therapy with booster sessions).
","['patients with osteoarthritis', 'Participants with knee osteoarthritis']","['exercise therapy delivered in consecutive sessions within 9 weeks (control group), exercise therapy distributed over 1 year using booster sessions, exercise therapy plus manual therapy delivered within 9 weeks, and exercise therapy plus manual therapy with booster sessions', 'exercise therapy']","['cost-effectiveness', 'incremental cost-effectiveness from health system and societal perspectives interpreted as incremental net monetary benefit (INMB']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1285553', 'cui_str': 'Interprets'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]",,0.0714341,"All three interventions were cost-effective from both the health system and societal perspectives (INMBs, at 0.5 × GDP/capita willingness to pay (WTP) threshold: $3278 (95%CI -3244 to 9800) and $3904 (95%CI -2823 to 10,632) respectively for booster sessions; $2941 (95%CI -3686 to 9568) and $2618 (95%CI -4005 to 9241) for manual therapy; $270 (95%CI -6139 to 6679) and $404 (95%CI -6097 to 6905) for manual therapy with booster sessions).
","[{'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Pryymachenko', 'Affiliation': 'Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Otago Medical School, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: yana.pryymachenko@otago.ac.nz.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Otago Medical School, University of Otago, PO Box 56, Dunedin, 9054, New Zealand.'}, {'ForeName': 'Saurab', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Otago Medical School, University of Otago, PO Box 56, Dunedin, 9054, New Zealand; Department of Physiotherapy, Kathmandu University School of Medical Sciences, Dhulikhel, Kavre, Nepal.'}, {'ForeName': 'Anupa', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Otago Medical School, University of Otago, PO Box 56, Dunedin, 9054, New Zealand.'}, {'ForeName': 'J Haxby', 'Initials': 'JH', 'LastName': 'Abbott', 'Affiliation': 'Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Otago Medical School, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: haxby.abbott@otago.ac.nz.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2021.102439']
1076,34375630,Response: Bilateral Arm Training vs Unilateral Arm Training for Severely Affected Patients With Stroke: Comments on Exploratory Single-Blinded Randomized Controlled Trial.,,2021,,[],['Bilateral Arm Training vs Unilateral Arm Training for Severely Letter to the Editor'],['Response'],[],"[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]",[],,0.0168259,,"[{'ForeName': 'Caroline I E', 'Initials': 'CIE', 'LastName': 'Renner', 'Affiliation': 'Department of Neurology/Early Rehabilitation, Mediclin Waldkrankenhaus Bad Düben, Bad Düben, Germany; NRZ Neurological Rehabilitation Center, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Hummelsheim', 'Affiliation': 'Department of Neurology/Early Rehabilitation, Mediclin Waldkrankenhaus Bad Düben, Bad Düben, Germany; NRZ Neurological Rehabilitation Center, University of Leipzig, Leipzig, Germany.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.06.019']
1077,34385507,Evaluation of acetylation and methylation in oral rinse of patients with head and neck cancer history exposed to valproic acid.,"Evaluate the biological action of valproic acid in the acetylation of histones and in the methylation of tumor suppressor genes via oral rinse in patients with a previous history of head and neck squamous cell carcinoma (HNSCC). Forty-two active or former smokers were included in this randomized, double-blind, placebo-controlled trial. Oral rinse samples were collected prior to treatment with valproic acid or placebo and after 90 days of treatment. The methylation status of five tumor suppressor genes and histone acetylation were evaluated by pyrosequencing and ELISA techniques, respectively. Differences between the 90-day and baseline oral rinse acetylation and methylation results were analyzed by comparing groups. Thirty-four patients were considered for analysis. The mean percentage adherence in the valproic and placebo groups was 93.4 and 93.0, respectively (p = 0.718). There was no statistically significant difference between groups when comparing the medians of the histone acetylation ratio and the methylation ratio for most of the studied genes. A significant reduction in the DCC methylation pattern was observed in the valproic group (p = 0.023). The use of valproic acid was safe and accompanied by good therapeutic adherence. DCC methylation was lower in the valproic acid group than in the placebo group.",2021,A significant reduction in the DCC methylation pattern was observed in the valproic group (p = 0.023).,"['patients with head and neck cancer history exposed to valproic acid', 'Forty-two active or former smokers', 'patients with a previous history of head and neck squamous cell carcinoma (HNSCC']","['valproic acid', 'placebo', 'valproic acid or placebo']","['histone acetylation ratio and the methylation ratio', 'mean percentage adherence', 'DCC methylation', 'DCC methylation pattern', 'methylation status of five tumor suppressor genes and histone acetylation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]","[{'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019652', 'cui_str': 'Histone'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1259909', 'cui_str': 'DCC protein, human'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079427', 'cui_str': 'Antioncogene'}]",34.0,0.188521,A significant reduction in the DCC methylation pattern was observed in the valproic group (p = 0.023).,"[{'ForeName': 'Ricardo Ribeiro', 'Initials': 'RR', 'LastName': 'Gama', 'Affiliation': 'Head and Neck Surgery Department, Barretos Cancer Hospital, Rua Antenor Duarte Villela, 1331, Bairro Dr. Paulo Prata, Barretos, SP, 14784-400, Brazil. ricardorgama@yahoo.com.br.'}, {'ForeName': 'Lidia Maria Rebolho Batista', 'Initials': 'LMRB', 'LastName': 'Arantes', 'Affiliation': 'Molecular Oncology Research Center, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Bruna Pereira', 'Initials': 'BP', 'LastName': 'Sorroche', 'Affiliation': 'Molecular Oncology Research Center, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'De Marchi', 'Affiliation': 'Clinical Oncology Department, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Matias Eliseo', 'Initials': 'ME', 'LastName': 'Melendez', 'Affiliation': 'Molecular Oncology Research Center, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Raiany Santos', 'Initials': 'RS', 'LastName': 'Carvalho', 'Affiliation': 'Researcher Support Center, Teaching and Research Institute, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Marcos Alves', 'Initials': 'MA', 'LastName': 'de Lima', 'Affiliation': 'Biostatistics Center, Teaching and Research Institute, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'André Luiz', 'Initials': 'AL', 'LastName': 'Vettore', 'Affiliation': 'Cancer Molecular Biology Laboratory, São Paulo Federal University, Diadema, SP, Brazil.'}, {'ForeName': 'André Lopes', 'Initials': 'AL', 'LastName': 'Carvalho', 'Affiliation': 'Head and Neck Surgery Department, Barretos Cancer Hospital, Rua Antenor Duarte Villela, 1331, Bairro Dr. Paulo Prata, Barretos, SP, 14784-400, Brazil.'}]",Scientific reports,['10.1038/s41598-021-95845-3']
1078,34385274,Effect of surgical mask on exercise capacity in COPD: a randomised crossover trial.,,2021,,['COPD'],['surgical mask'],['exercise capacity'],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0181758', 'cui_str': 'Surgical face mask'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.107722,,"[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Hirai', 'Affiliation': 'Dept of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine, Tokyo, Japan hiraik@med.showa-u.ac.jp.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Dept of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Dept of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Dept of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Dept of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Inoue', 'Affiliation': 'Showa University Research Administration Center, Showa University, Tokyo, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Sagara', 'Affiliation': 'Dept of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine, Tokyo, Japan.'}]",The European respiratory journal,['10.1183/13993003.02041-2021']
1079,34384301,Duration and onset of effect of incobotulinumtoxinA for the treatment of blepharospasm in botulinum toxin-naïve subjects.,"OBJECTIVE


Blepharospasm is a focal dystonia whereby excessive eyelid muscle contractions cause involuntary eye closure. Botulinum neurotoxin type A (BoNT-A) injections are an approved treatment. This randomized placebo-controlled trial (NCT01896895; EudraCT number 2012-004821-26) assessed the efficacy, safety, and treatment effect duration of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH), a BoNT-A formulation without complexing proteins, in BoNT-A-naïve adults with blepharospasm.
METHODS


Subjects received incobotulinumtoxinA 50 U, 25 U (total dose) or placebo during a main study period (MP; 6-20 weeks). Patients needing a second injection received incobotulinumtoxinA ≤70 U in an open-label extension period (EP; 6-20 weeks). Treatment effect durations were time from first injection to EP injection or final MP visit and from EP injection to end-of-study visit. Times to effect onset and to waning of effect (MP) were time from injection to first subject-assessed onset effect and time from injection to subject-reported waning of effect, respectively.
RESULTS


Of 61 subjects, 39 entered the EP. During the MP, median duration of treatment effect was longer with incobotulinumtoxinA 50 U (20 weeks) versus incobotulinumtoxinA 25 U (11 weeks) or placebo (6 weeks). Median duration of treatment effect was 20 weeks during the EP. Median time to effect onset was 5, 7, and 14 days with 50 U, 25 U, and placebo, respectively ( p  = .022 for 50 U versus placebo). Median time to waning of treatment effect was comparable between groups.
CONCLUSION


Subjects reported an effect onset from 5 days after injection lasting up to 20 weeks (maximum observation period). Data indicate that incobotulinumtoxinA re-treatment of blepharospasm may not be required at fixed 12-week intervals and provide evidence for a patient-tailored approach.",2021,Median time to waning of treatment effect was comparable between groups.,"['61 subjects, 39 entered the EP', 'botulinum toxin-naïve subjects']","['incobotulinumtoxina', 'Blepharospasm', 'Botulinum neurotoxin type A (BoNT-A) injections', 'incobotulinumtoxinA', 'incobotulinumtoxinA 50\u2009U, 25\u2009U (total dose) or placebo', 'incobotulinumtoxinA ≤70\u2009U in an open-label extension', 'placebo']","['Median time to waning of treatment effect', 'Median duration of treatment effect', 'Median time to effect onset', 'efficacy, safety']","[{'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0913027,Median time to waning of treatment effect was comparable between groups.,"[{'ForeName': 'Dimos D', 'Initials': 'DD', 'LastName': 'Mitsikostas', 'Affiliation': '1st Neurology Department, Aeginition Hospital, Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Dekundy', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Althaus', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Scheschonka', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Department of Neurology, Georgetown University Hospital Pasquerilla Healthcare Center, Washington, DC, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jankovic', 'Affiliation': ""Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, TX, USA.""}]",Current medical research and opinion,['10.1080/03007995.2021.1965975']
1080,34387411,DUAL II China: Superior HbA1c reductions and weight loss with insulin degludec/liraglutide (IDegLira) versus insulin degludec in a randomized trial of Chinese people with type 2 diabetes inadequately controlled on basal insulin.,"AIM


To assess the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (degludec) in Chinese people with type 2 diabetes (T2D) treated with basal insulin.
MATERIALS AND METHODS


In DUAL II China, a randomized, double-blinded, multicentre, treat-to-target trial, Chinese adults with T2D and HbA1c of 7.5% or more on basal insulin and metformin, with or without other oral antidiabetic drugs (OADs), were randomized 2:1 to 26 weeks of treatment with either IDegLira (max. dose 50 U degludec/1.8 mg liraglutide) or degludec (max. 50 U/day), respectively, combined with metformin. At 26 weeks, superiority of IDegLira over degludec was assessed for change in HbA1c (primary endpoint), and body weight and number of severe or blood glucose (BG)-confirmed hypoglycaemic episodes (confirmatory secondary endpoints).
RESULTS


Overall, 453 participants were randomized to IDegLira (n = 302) or degludec (n = 151). Superiority was confirmed for IDegLira over degludec in HbA1c change (-1.9% vs. -1.0%, respectively, estimated treatment difference [ETD] [95% confidence interval]: -0.92% [-1.09; -0.75], P < .0001), body weight change (-0.7 vs. +0.4 kg, respectively, ETD [95% CI]: -1.08 kg [-1.63; -0.52], P = .0002) and severe or BG-confirmed hypoglycaemia (estimated rate ratio [95% CI]: 0.53 [0.30; 0.94], P = .0297). The odds of achieving HbA1c less than 7.0% without hypoglycaemia and/or weight gain were greater with IDegLira than degludec (P < .0001 for all). Daily insulin dose at 26 weeks was lower for IDegLira (34.3 U) than degludec (37.4 U) (P = .0014). No unexpected safety signals were observed.
CONCLUSIONS


IDegLira may be an efficacious and well-tolerated treatment intensification option for Chinese people with T2D uncontrolled on basal insulin and OADs.",2021,"Superiority was confirmed for IDegLira over degludec in HbA 1c  change (-1.9% versus -1.0%, respectively, estimated treatment difference (ETD) [95% confidence interval]: -0.92% [-1.09;-0.75], p < 0.0001), body weight change (-0.7 kg versus +0.4 kg, respectively, ETD [95% CI]: -1.08 kg [-1.63;-0.52], p = 0.0002) and severe or BG-confirmed hypoglycaemia (estimated rate ratio [95% CI]: 0.53 [0.30;0.94], p = 0.0297).","['Chinese adults with T2D and glycated haemoglobin (HbA 1c  ', 'Chinese people with type 2 diabetes (T2D) treated with basal insulin', '50', 'Chinese people with type 2 diabetes inadequately controlled on basal insulin', '453 participants were randomized to IDegLira (n\xa0=\xa0302) or degludec (n\xa0=\xa0151', 'Chinese people with T2D uncontrolled on basal insulin and OADs']","['basal insulin and metformin, with or without other oral-antidiabetic drugs (OADs', 'liraglutide (IDegLira', 'metformin', 'liraglutide', 'insulin degludec/liraglutide (IDegLira) versus insulin degludec (degludec']","['severe or BG-confirmed hypoglycaemia', 'hypoglycaemia and/or weight gain', 'body weight and number of severe or blood glucose (BG)-confirmed hypoglycaemic episodes', 'body weight change']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec and liraglutide'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec and liraglutide'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",453.0,0.3126,"Superiority was confirmed for IDegLira over degludec in HbA 1c  change (-1.9% versus -1.0%, respectively, estimated treatment difference (ETD) [95% confidence interval]: -0.92% [-1.09;-0.75], p < 0.0001), body weight change (-0.7 kg versus +0.4 kg, respectively, ETD [95% CI]: -1.08 kg [-1.63;-0.52], p = 0.0002) and severe or BG-confirmed hypoglycaemia (estimated rate ratio [95% CI]: 0.53 [0.30;0.94], p = 0.0297).","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Pei', 'Affiliation': ""Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Bue R', 'Initials': 'BR', 'LastName': 'Agner', 'Affiliation': 'Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': 'Novo Nordisk China Pharmaceuticals, Beijing, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Department of Endocrinology, Jinan Central Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Fifth People's Hospital of Shanghai, Shanghai, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology and Metabolism, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Novo Nordisk Pharma Ltd, Tokyo, Japan.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Fuzhou General Hospital, Fuzhou, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Mu', 'Affiliation': ""Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, China.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14522']
1081,34387236,Effect of Reiki Therapy on Quality of Life and Fatigue Levels of Breast Cancer Patients Receiving Chemotherapy.,"BACKGROUND


The quality of life of patients receiving chemotherapy decreases, and fatigue is one of the most common symptoms. Reiki is used for cancer patients as an energy-based complementary and alternative method.
OBJECTIVE


The aim of this study was to determine the effect of Reiki therapy on the quality of life and fatigue levels in breast cancer patients receiving chemotherapy.
METHODS


This was a pretest-posttest, quasi-experimental study with a control group: 70 patients enrolled with 35 participants in the experimental group and 35 in the control group. The experimental group received 6 sessions of Reiki therapy. The data were collected using a Patient Information Form, the Piper Fatigue Scale, and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire.
RESULTS


The mean scores on the general well-being subscale in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire increased in the experimental group and decreased in the control group, whereas the mean scores on the general function and general symptom subscales decreased in the experimental group and increased in the control group. The differences between the groups were statistically significant (P < .001). The mean Piper Fatigue Scale scores of the experimental group decreased, whereas that of the control group increased; the group differences were statistically significant (P < .001).
CONCLUSION


Reiki can reduce fatigue and increase the quality of life of breast cancer patients receiving chemotherapy.
IMPLICATIONS FOR PRACTICE


Reiki therapy can be used as a nursing intervention to increase the quality of life and reduce fatigue in breast cancer patients receiving chemotherapy.",2021,Reiki therapy can be used as a nursing intervention to increase the quality of life and reduce fatigue in breast cancer patients receiving chemotherapy.,"['breast cancer patients receiving chemotherapy', 'group: 70 patients enrolled with 35 participants in the experimental group and 35 in the control group', 'Breast Cancer Patients Receiving Chemotherapy']","['Reiki Therapy', 'control', 'Reiki therapy', '6 sessions of Reiki therapy']","['Quality of Life and Fatigue Levels', 'quality of life and reduce fatigue', 'quality of life and fatigue levels', 'general function and general symptom subscales', 'Cancer Quality of Life Questionnaire', 'quality of life', 'mean Piper Fatigue Scale scores']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0751715', 'cui_str': 'Reiki'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0159028', 'cui_str': 'General symptom'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.0318097,Reiki therapy can be used as a nursing intervention to increase the quality of life and reduce fatigue in breast cancer patients receiving chemotherapy.,"[{'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Karaman', 'Affiliation': 'Author Affiliation: Department of Internal Medicine Nursing, Faculty of Nursing, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Mehtap', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000970']
1082,33831896,Appetite and Energy Intake Regulation in Response to Acute Exercise.,"PURPOSE


This study aimed to determine if energy intake and appetite regulation differ in response to an acute bout of resistance exercise (REx) versus aerobic exercise (AEx).
METHODS


Physically inactive adults (n = 24, 35% ± 2% body fat, 50% female) completed three conditions: AEx (walking at 65%-70% heart rate max for 45 min), REx (1 set to failure of 12 exercises), and sedentary control (SED). Each condition was initiated in the postprandial state (35 min after breakfast). Appetite (visual analog scale for hunger, satiety, and prospective food consumption) and hormones (ghrelin, peptide YY (PYY), and glucagon-like peptide-1 (GLP-1)) were measured before and 30, 90, 120, 150, and 180 min after a standardized breakfast. Area under the curve was calculated using the trapezoid method. Ad libitum energy intake was evaluated at a lunch meal after the 180-min measurements.
RESULTS


No differences in ad libitum energy intake (REx, 991 ± 68; AEx, 937 ± 65; SED, 944 ± 76 kcal; P = 0.50) or appetite ratings (all, P > 0.05) were detected. The area under the curve for ghrelin, PYY, and GLP-1 were all lower after REx versus AEx (ghrelin: 130,737 ± 4928 for REx; 143,708 ± 7500 for AEx (P = 0.006); PYY: 20,540 ± 1177 for REx, 23,812 ± 1592 for AEx (P = 0.001); and GLP-1: 1314 ± 93 for REx, 1615 ± 110 for AEx (P = 0.013)). Neither exercise condition significantly differed from SED.
CONCLUSIONS


Acute REx lowers both orexigenic (ghrelin) and anorectic (PYY and GLP-1) gut peptides compared with acute AEx. Ad libitum energy intake did not increase compared with SED in either exercise condition, indicating both exercise modalities have appetite and energy intake suppressing effects. Future work is needed to determine if exercise of differing modalities influences chronic appetite regulation.",2021,"AUC for ghrelin, PYY, and GLP-1 were all lower following REx vs. AEx (Ghrelin: REx: 130,737±4,928; AEx: 143,708±7,500, p=0.006; PYY: REx: 20,540±1,177; AEx: 23,812±1,592, p=0.001; and GLP-1: REx: 1,314±93; AEx: 1,615±110, p=0.013).","['n=24, 35±2% body fat, 50% female) completed 3 conditions: AEx (walking at 65-70% heart rate max for 45 minutes); REx (1-set to failure of 12 exercises); and sedentary control (SED', 'Physically inactive adults ']",['resistance exercise (REx) vs aerobic exercise (AEx'],"['nor appetite ratings', 'Appetite and Energy Intake Regulation', 'Area under the curve (AUC', 'Appetite (visual analogue scale [VAS] for hunger, satiety, and prospective food consumption and hormones (ghrelin, PYY, and GLP-1']","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",,0.0471045,"AUC for ghrelin, PYY, and GLP-1 were all lower following REx vs. AEx (Ghrelin: REx: 130,737±4,928; AEx: 143,708±7,500, p=0.006; PYY: REx: 20,540±1,177; AEx: 23,812±1,592, p=0.001; and GLP-1: REx: 1,314±93; AEx: 1,615±110, p=0.013).","[{'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Halliday', 'Affiliation': ''}, {'ForeName': 'Mollie H', 'Initials': 'MH', 'LastName': 'White', 'Affiliation': 'Anschutz Health & Wellness Center at the University of Colorado, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Allison K', 'Initials': 'AK', 'LastName': 'Hild', 'Affiliation': 'Anschutz Health & Wellness Center at the University of Colorado, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': ''}, {'ForeName': 'Marc-Andre', 'Initials': 'MA', 'LastName': 'Cornier', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002678']
1083,33837481,Effectiveness and Safety of Moxibustion Robots on Primary Dysmenorrhea: A Randomized Controlled Pilot Trial.,"OBJECTIVE


To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea (PD) and evaluate its feasibility in clinic.
METHODS


A total of 70 participants with PD were allocated to either moxibustion robot (MR) group (35 cases) or manual moxibustion (MM) group (35 cases) using computer-generated randomization. One acupoint Guanyuan (CV 4) was selected to receive moxa heat stimulation. Two groups of participants were given 3 menstrual cycles of MM and MR treatment respectively (once a day, 5 days a session) and received another 3 menstrual cycles follow-up. The degree of pain was evaluated by short-form McGill pain questionnaire (SF-MPQ) and the symptoms of dysmenorrhea were evaluated by Cox Menstrual Symptom Scale (CMSS). The safety was measured by the occurrence rate of adverse events (AEs), including burns (blisters, red and swollen), itching, bowel changes, menstrual cycle disorder, menorrhagia and fatigue, etc. RESULTS: A total of 62 patients completed the trial, 32 in MR group and 30 in MM group. Compared with baseline, scores of SF-MPQ and CMSS significantly decreased in both groups (P<0.05), and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles (P>0.05). The total occurrence rate of AEs in MR group was 2.1%, which was significantly lower than MM group (7.2%, P<0.05).
CONCLUSIONS


MR has the same effect as MM at SF-MPQ and CMSS in patients with PD. However, MR is safer than MM (Trial registration No. ChiCTR1800018236).",2021,"Compared with baseline, scores of SF-MPQ and CMSS significantly decreased in both groups (P<0.05), and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles (P>0.05).","['Primary Dysmenorrhea', '62 patients completed the trial, 32 in MR group and 30 in MM group', 'patients with PD', '70 participants with PD']","['moxibustion robots', 'moxibustion robot (MR) group (35 cases) or manual moxibustion (MM', 'Moxibustion Robots']","['Cox Menstrual Symptom Scale (CMSS', 'McGill pain questionnaire (SF-MPQ) and the symptoms of dysmenorrhea', 'occurrence rate of adverse events (AEs), including burns (blisters, red and swollen), itching, bowel changes, menstrual cycle disorder, menorrhagia and fatigue, etc', 'total occurrence rate of AEs', 'degree of pain', 'scores of SF-MPQ and CMSS']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0025345', 'cui_str': 'Disorder of menstruation'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.0559548,"Compared with baseline, scores of SF-MPQ and CMSS significantly decreased in both groups (P<0.05), and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles (P>0.05).","[{'ForeName': 'Han-Rui', 'Initials': 'HR', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Tu', 'Affiliation': 'College of Electrical Engineering, Sichuan University, Chengdu, 610065, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Rehabilitation, Chengdu Fifth People's Hospital, Chengdu, 611130, China.""}, {'ForeName': 'Shi-Lin', 'Initials': 'SL', 'LastName': 'Xia', 'Affiliation': 'College of Electrical Engineering, Sichuan University, Chengdu, 610065, China.'}, {'ForeName': 'Guo-You', 'Initials': 'GY', 'LastName': 'Zhao', 'Affiliation': 'College of Electrical Engineering, Sichuan University, Chengdu, 610065, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Ying-Kun', 'Initials': 'YK', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China. 975470100@qq.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-3287-8']
1084,33843948,Effects of a Self-directed Web-Based Strengthening Exercise and Physical Activity Program Supported by Automated Text Messages for People With Knee Osteoarthritis: A Randomized Clinical Trial.,"Importance


Exercise therapies are advocated in osteoarthritis (OA) clinical guidelines. However, challenges to accessing exercise may be limiting widespread uptake.
Objective


To evaluate the effects of a self-directed web-based strengthening exercise and physical activity program supported by automated behavior-change text messages on knee pain and function for people with knee OA.
Design, Setting, and Participants


The participant-blinded and assessor-blinded randomized clinical trial enrolled 206 people who met clinical criteria for knee OA in communities across Australia from July 2018 to August 2019, with follow-up taking place at 24 weeks.
Interventions


The control group was given access to a custom-built website with information on OA and the importance of exercise and physical activity. The intervention group was given access to the same information plus a prescription for a 24-week self-directed strengthening regimen and guidance to increase physical activity, supported by automated behavior-change text messages encouraging exercise adherence.
Main Outcomes and Measures


Primary outcomes were change in overall knee pain (numeric rating scale, 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68) over 24 weeks. Secondary outcomes were another knee pain measure, sport and recreation function, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction.
Results


Of 206 participants, 180 (87%; mean [SD] age, 60 [8.4] years; 109 [61%] women) completed both 24-week primary outcomes. The intervention group showed greater improvements in overall knee pain (mean difference, 1.6 units; 95% CI, 0.9-2.2 units; P < .001) and physical function (mean difference, 5.2 units; 95% CI, 1.9-8.5 units; P = .002) compared with the control. There was evidence of differences in the proportion of participants exceeding the minimal clinically important improvement in pain (intervention group, 72.1%, vs control, 42.0%; risk difference, 0.30 [95% CI, 0.16-0.44]; P <. 001) and function (intervention group, 68%, vs control, 40.8%; risk difference, 0.27 [95% CI, 0.13-0.41]; P < .001) favoring the intervention. Between-group differences for all secondary outcomes favored the intervention except for physical activity, self-efficacy for function, and self-efficacy for exercise, for which there was no evidence of differences.
Conclusions and Relevance


This randomized clinical trial found that a self-directed web-based strengthening exercise regimen and physical activity guidance supported by automated behavior-change text messages to encourage exercise adherence improved knee pain and function at 24 weeks. This unsupervised, free-to-access digital intervention is an effective option to improve patient access to recommended OA exercise and/or to support clinicians in providing exercise management for people with knee OA at scale across the population.
Trial Registration


Australian New Zealand Clinical Trials Registry Identifier: ACTRN12618001167257.",2021,"The intervention group showed greater improvements in overall knee pain (mean difference, 1.6 units; 95% CI, 0.9-2.2 units; P < .001) and physical function (mean difference, 5.2 units; 95% CI, 1.9-8.5 units; P = .002) compared with the control.","['mean [SD] age, 60 [8.4] years', 'People With Knee Osteoarthritis', '206 participants, 180 (87', 'people with knee OA', '206 people who met clinical criteria for knee OA in communities across Australia from July 2018 to August 2019, with follow-up taking place at 24 weeks']","['OA exercise', 'Self-directed Web-Based Strengthening Exercise and Physical Activity Program Supported by Automated Text Messages', 'self-directed web-based strengthening exercise and physical activity program supported by automated behavior-change text messages']","['overall knee pain (numeric rating scale, 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68', 'pain', 'knee pain measure, sport and recreation function, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction', 'physical activity, self-efficacy for function, and self-efficacy for exercise', 'physical function', 'overall knee pain']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",206.0,0.0553334,"The intervention group showed greater improvements in overall knee pain (mean difference, 1.6 units; 95% CI, 0.9-2.2 units; P < .001) and physical function (mean difference, 5.2 units; 95% CI, 1.9-8.5 units; P = .002) compared with the control.","[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Nelligan', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samuel J C', 'Initials': 'SJC', 'LastName': 'Crofts', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}]",JAMA internal medicine,['10.1001/jamainternmed.2021.0991']
1085,33843831,The small (14 Fr) percutaneous catheter (P-CAT) versus large (28-32 Fr) open chest tube for traumatic hemothorax: A multicenter randomized clinical trial.,"INTRODUCTION


The traditional treatment of traumatic hemothorax (HTX) has been an insertion of a large-bore 36- to 40-Fr chest tube. Our previous single-center randomized controlled trial (RCT) had shown that 14-Fr percutaneous catheters (PCs) (pigtail) were equally as effective as chest tube. We performed a multicenter RCT, hypothesizing that PCs are as equally effective as chest tubes in the management of patients with traumatic HTX (NCT03546764).
METHODS


We performed a multi-institution prospective RCT comparing 14-Fr PCs with 28- to 32-Fr chest tubes in the management of patients with traumatic HTX from July 2015 to September 2020. We excluded patients who were in extremis and required emergent tube placement and those who refused to participate. The primary outcome was failure rate, defined as a retained HTX requiring a second intervention. Secondary outcomes included daily drainage output, tube days, intensive care unit and hospital length of stay, and insertion perception experience (IPE) score on a scale of 1 to 5 (1, tolerable experience; 5, worst experience). Unpaired Student's t test, χ2, and Wilcoxon rank sum test were used with significance set at p < 0.05.
RESULTS


After exclusion, 119 patients participated in the trial, 56 randomized to PCs and 63 to chest tubes. Baseline characteristics between the two groups were similar. The primary outcome, failure rate, was similar between the two groups (11% PCs vs. 13% chest tubes, p = 0.74). All other secondary outcomes were also similar, except PC patients reported lower IPE scores (median, 1: ""I can tolerate it""; interquartile range, 1-2) than chest tube patients (median, 3: ""It was a bad experience""; interquartile range, 2-5; p < 0.001).
CONCLUSION


Small caliber 14-Fr PCs are equally as effective as 28- to 32-Fr chest tubes in their ability to drain traumatic HTX with no difference in complications. Patients reported better IPE scores with PCs over chest tubes, suggesting that PCs are better tolerated.
LEVEL OF EVIDENCE


Therapeutic, level II.",2021,"All other secondary outcomes were also similar, except PC patients reported lower IPE scores (median, 1, ""I can tolerate it""; IR, 1-2) than CT patients (median, 3, ""It was a bad experience""; IR, 2-5, P<0.001).
","['patients with traumatic HTX from July, 2015 to September, 2020', '119 patients participated in the trial, 56 randomized to PCs and 63 to CTs', 'patients who were in extremis and required emergent tube placement, and those who refused to participate', 'patients with traumatic HTX']","['traumatic hemothorax (HTX', '14Fr percutaneous catheters (PCs) (pigtail', 'Fr) Percutaneous Catheter vs. Large (28-32Fr) Open Chest Tube for Traumatic Hemothorax (P-CAT']","['daily drainage output, tube days, intensive care unit and hospital length of stay, and insertion perception experience (IPE) score on a scale of 1 to 5 (1=tolerable experience, 5=worst experience', 'tolerated', 'IPE scores', 'failure rate', 'failure rate, defined as a retained HTX requiring a second intervention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340006', 'cui_str': 'Traumatic hemothorax'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}]","[{'cui': 'C0340006', 'cui_str': 'Traumatic hemothorax'}, {'cui': 'C0019123', 'cui_str': 'Hemothorax'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C2585679', 'cui_str': '32 French gauge'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0019123', 'cui_str': 'Hemothorax'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",119.0,0.105864,"All other secondary outcomes were also similar, except PC patients reported lower IPE scores (median, 1, ""I can tolerate it""; IR, 1-2) than CT patients (median, 3, ""It was a bad experience""; IR, 2-5, P<0.001).
","[{'ForeName': 'Narong', 'Initials': 'N', 'LastName': 'Kulvatunyou', 'Affiliation': 'From the Division of Acute Care Surgery, Department of Surgery (N.K., L.G., A.L.T., B.J.), University of Arizona, Tucson, Arizona; Division of Acute Care Surgery, Department of Surgery (Z.M.B.), University of Nebraska, Omaha, Nebraska; Division of Acute Care Surgery, Department of Surgery (S.B.Z.E., M.d.M.), Medical College of Wisconsin, Milwaukee, Wisconsin; Division of Acute Care Surgery, Department of Surgery (C.K., K.M.), Loma Linda University, Loma Linda, California; and Department of Surgery (P.R.), New York Medical College, Valhalla, New York.'}, {'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Bauman', 'Affiliation': ''}, {'ForeName': 'Savo Bou', 'Initials': 'SB', 'LastName': 'Zein Edine', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'de Moya', 'Affiliation': ''}, {'ForeName': 'Casandra', 'Initials': 'C', 'LastName': 'Krause', 'Affiliation': ''}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Mukherjee', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Gries', 'Affiliation': ''}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Bellal', 'Initials': 'B', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rhee', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003180']
1086,33843820,"Effects of Ayahuasca on the Recognition of Facial Expressions of Emotions in Naive Healthy Volunteers: A Pilot, Proof-of-Concept, Randomized Controlled Trial.","BACKGROUND


The recognition of emotions in facial expressions (REFE) is a core aspect of social cognition. Previous studies with the serotonergic hallucinogens lysergic acid diethylamide and psilocybin showed that these drugs reduced the recognition of negative (fear) faces in healthy volunteers. This trial assessed the acute and prolonged effects of a single dose of ayahuasca on the REFE.
METHODS


Twenty-two healthy volunteers participated in a pilot, proof-of-concept, randomized trial. Study variables included a REFE task performed before and 4 hours after drug intake, subjective effects (self-reports/observer impressions), tolerability measures (cardiovascular measures, self-reports), and brain-derived neurotrophic factor plasma levels. The REFE task was applied again 1, 7, 14, and 21 days and 3 months after drug intake. Stability of ayahuasca alkaloids during the study was also assessed (room temperature, 18 months).
FINDINGS


Compared with placebo, ayahuasca did not modify the REFE. No significant effects were observed on cardiovascular measures and brain-derived neurotrophic factor levels. Volunteers reported visual effects, tranquility/relaxation, and well-being, with few reports of transient anxiety/confusion. Ayahuasca was well tolerated, producing mainly nausea, gastrointestinal discomfort, and vomiting. A significant time-dependent deterioration of alkaloids was observed, especially for dimethyltryptamine.
CONCLUSIONS


Absence of significant effects on the REFE task could be due to lack of effects of ayahuasca (at the doses used), alkaloid degradation, learning effects, and the high educational level of the sample. Further trials with different samples are needed to better understand the effects of ayahuasca and other serotonergic hallucinogens on the REFE. Future trials should improve methods to guarantee the stability of ayahuasca alkaloids.",2021,No significant effects were observed on cardiovascular measures and brain-derived neurotrophic factor levels.,"['healthy volunteers', 'Naive Healthy Volunteers', 'Twenty-two healthy volunteers participated in a pilot, proof-of-concept, randomized trial']","['ayahuasca', 'ayahuasca alkaloids', 'Ayahuasca', 'placebo, ayahuasca']","['Facial Expressions of Emotions', 'subjective effects (self-reports/observer impressions), tolerability measures (cardiovascular measures, self-reports), and brain-derived neurotrophic factor plasma levels', 'recognition of negative (fear) faces', 'visual effects, tranquility/relaxation', 'time-dependent deterioration of alkaloids', 'cardiovascular measures and brain-derived neurotrophic factor levels', 'tolerated, producing mainly nausea, gastrointestinal discomfort, and vomiting']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0556981', 'cui_str': '% proof'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}, {'cui': 'C0002062', 'cui_str': 'Alkaloid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0002062', 'cui_str': 'Alkaloid'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",22.0,0.0369101,No significant effects were observed on cardiovascular measures and brain-derived neurotrophic factor levels.,"[{'ForeName': 'Juliana Mendes', 'Initials': 'JM', 'LastName': 'Rocha', 'Affiliation': 'From the Department of Neurosciences and Behavior, Ribeirão Preto Medical School, University of São Paulo.'}, {'ForeName': 'Giordano Novak', 'Initials': 'GN', 'LastName': 'Rossi', 'Affiliation': 'From the Department of Neurosciences and Behavior, Ribeirão Preto Medical School, University of São Paulo.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'de Lima Osório', 'Affiliation': ''}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Bouso', 'Affiliation': ''}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'de Oliveira Silveira', 'Affiliation': 'School of Pharmaceutical Sciences.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Yonamine', 'Affiliation': 'School of Pharmaceutical Sciences.'}, {'ForeName': 'Alline Cristina', 'Initials': 'AC', 'LastName': 'Campos', 'Affiliation': 'Department of Pharmacology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Bertozi', 'Affiliation': 'Department of Pharmacology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Jaime E', 'Initials': 'JE', 'LastName': 'Cecílio Hallak', 'Affiliation': ''}, {'ForeName': 'Rafael G', 'Initials': 'RG', 'LastName': 'Dos Santos', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001396']
1087,34379916,A Monoclonal Antibody for Malaria Prevention.,"BACKGROUND


Additional interventions are needed to reduce the morbidity and mortality caused by malaria.
METHODS


We conducted a two-part, phase 1 clinical trial to assess the safety and pharmacokinetics of CIS43LS, an antimalarial monoclonal antibody with an extended half-life, and its efficacy against infection with  Plasmodium falciparum . Part A of the trial assessed the safety, initial side-effect profile, and pharmacokinetics of CIS43LS in healthy adults who had never had malaria. Participants received CIS43LS subcutaneously or intravenously at one of three escalating dose levels. A subgroup of participants from Part A continued to Part B, and some received a second CIS43LS infusion. Additional participants were enrolled in Part B and received CIS43LS intravenously. To assess the protective efficacy of CIS43LS, some participants underwent controlled human malaria infection in which they were exposed to mosquitoes carrying  P. falciparum  sporozoites 4 to 36 weeks after administration of CIS43LS.
RESULTS


A total of 25 participants received CIS43LS at a dose of 5 mg per kilogram of body weight, 20 mg per kilogram, or 40 mg per kilogram, and 4 of the 25 participants received a second dose (20 mg per kilogram regardless of initial dose). No safety concerns were identified. We observed dose-dependent increases in CIS43LS serum concentrations, with a half-life of 56 days. None of the 9 participants who received CIS43LS, as compared with 5 of 6 control participants who did not receive CIS43LS, had parasitemia according to polymerase-chain-reaction testing through 21 days after controlled human malaria infection. Two participants who received 40 mg per kilogram of CIS43LS and underwent controlled human malaria infection approximately 36 weeks later had no parasitemia, with serum concentrations of CIS43LS of 46 and 57 μg per milliliter at the time of controlled human malaria infection.
CONCLUSIONS


Among adults who had never had malaria infection or vaccination, administration of the long-acting monoclonal antibody CIS43LS prevented malaria after controlled infection. (Funded by the National Institute of Allergy and Infectious Diseases; VRC 612 ClinicalTrials.gov number, NCT04206332.).",2021,No safety concerns were identified.,"['participants underwent controlled human malaria infection in which they were exposed to mosquitoes carrying  P. falciparum  sporozoites 4 to 36 weeks after administration of CIS43LS', 'adults who had never had malaria infection or vaccination, administration of the long-acting monoclonal antibody CIS43LS prevented malaria after controlled infection', 'healthy adults who had never had malaria']","['40 mg per kilogram of CIS43LS', 'CIS43LS', 'CIS43LS subcutaneously']",['CIS43LS serum concentrations'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0562648', 'cui_str': 'Kingdom Protozoa sporozoite'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0439209', 'cui_str': 'kg'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",2.0,0.393783,No safety concerns were identified.,"[{'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Gaudinski', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Berkowitz', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Azza H', 'Initials': 'AH', 'LastName': 'Idris', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Coates', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'LaSonji A', 'Initials': 'LA', 'LastName': 'Holman', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Floreliz', 'Initials': 'F', 'LastName': 'Mendoza', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Ingelise J', 'Initials': 'IJ', 'LastName': 'Gordon', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Plummer', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Trofymenko', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Zonghui', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Andrezza', 'Initials': 'A', 'LastName': 'Campos Chagas', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': ""O'Connell"", 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Basappa', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Douek', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Sandeep R', 'Initials': 'SR', 'LastName': 'Narpala', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Barry', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Alicia T', 'Initials': 'AT', 'LastName': 'Widge', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Renunda', 'Initials': 'R', 'LastName': 'Hicks', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Seemal F', 'Initials': 'SF', 'LastName': 'Awan', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Wu', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Somia', 'Initials': 'S', 'LastName': 'Hickman', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Wycuff', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Stein', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Case', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Evans', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Carlton', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Gall', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Vazquez', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Flach', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Francica', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Flynn', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Neville K', 'Initials': 'NK', 'LastName': 'Kisalu', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McDermott', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Seder', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2034031']
1088,34383515,Investigating the effects of the Moms' Empowerment Program on 8-year traumatic stress symptom trajectories in women with histories of IPV.,"OBJECTIVE


Intimate partner violence (IPV) is a pressing issue, affecting nearly one-third of women in the U.S. over their lifetimes, and has been linked with a number of deleterious outcomes, including the development of posttraumatic stress disorder (PTSD). Although IPV is often chronic, few studies have prospectively examined trajectories of PTSD symptoms (PTSS) in this population. The goal of the present study was to assess the effects of the Moms' Empowerment Program-an IPV-specific intervention; as well as trauma exposure, domestic violence (DV) shelter use, and depression symptoms on PTSS trajectories in women with histories of IPV.
METHOD


Data were drawn from a sample of 118 women who participated in a randomized controlled trial (RCT) of an intervention specifically designed for women and children experiencing IPV. Sixty-seven women from the original sample completed an assessment 8 years following the conclusion of the intervention.
RESULTS


On average, women's PTSS decreased over time. Intervention group assignment did not affect these trajectories; however, women who attended more sessions had significantly fewer PTSS at the 8-year follow-up. Greater IPV exposure, higher depression symptoms, and shelter use were all associated with higher PTSS over time, with some variation across PTSS subdomains.
CONCLUSIONS


These results provide preliminary evidence that brief intervention may have long-term effects. They also demonstrate how addressing ongoing IPV and concurrent symptoms of depression is likely an essential component of treating PTSS in this population. Finally, these results underscore the need for more research on relations between formal DV services and mental health. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Greater IPV exposure, higher depression symptoms, and shelter use were all associated with higher PTSS over time, with some variation across PTSS subdomains.
","['Sixty-seven women from the original sample completed an assessment 8 years following the conclusion of the intervention', 'women with histories of IPV', 'Intimate partner violence (IPV', 'Data were drawn from a sample of 118 women who participated in a randomized controlled trial (RCT) of an intervention specifically designed for women and children experiencing IPV']","[""Moms' Empowerment Program-an IPV-specific intervention"", ""Moms' Empowerment Program""]","['PTSS', '8-year traumatic stress symptom trajectories']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]",67.0,0.0360775,"Greater IPV exposure, higher depression symptoms, and shelter use were all associated with higher PTSS over time, with some variation across PTSS subdomains.
","[{'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Galano', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Sara F', 'Initials': 'SF', 'LastName': 'Stein', 'Affiliation': 'School of Social Work.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Grogan-Kaylor', 'Affiliation': 'School of Social Work.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Clark', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Graham-Bermann', 'Affiliation': 'Department of Psychology.'}]",The American journal of orthopsychiatry,['10.1037/ort0000577']
1089,34387408,Liraglutide reduces cardiac adipose tissue in type 2 diabetes: A secondary analysis of the LIRAFLAME randomized placebo-controlled trial.,"AIM


To test the hypothesis that treatment with liraglutide can reduce cardiac adipose tissue.
MATERIALS AND METHODS


LIRAFLAME is a randomized placebo-controlled, double-blind, parallel clinical study. Participants with type 2 diabetes were randomized to treatment with liraglutide 1.8 mg/d or placebo for 26 weeks. Computed tomography was performed at baseline and at end of treatment to evaluate the cardiac adipose tissue volume, quantified automatically. We report the results of a secondary endpoint evaluating changes in cardiac adipose tissue.
RESULTS


A total of 102 participants were randomly assigned to liraglutide (n = 51) or placebo (n = 51). At baseline, the mean (SD) cardiac adipose tissue volume was comparable between the liraglutide and the placebo group (232.6 [112.8] vs. 227.0 [103.2] mL; P = 0.80). The mean change in body weight was -3.7 (-4.8, -2.6) kg in the liraglutide and -0.18 (-0.76, 0.40) kg in the placebo group. From baseline to end of treatment the mean cardiac adipose tissue change was -11.5 (95% confidence interval -17.6, -5.4) mL in the liraglutide (P < 0.001) and -0.01 (-5.3, 5.3) mL in the placebo (P = 1.00) groups. The reduction in cardiac adipose tissue was significantly greater in the liraglutide compared to the placebo group (mean difference -11.4 [-19.4, -3.3] mL; P = 0.006), but significance was lost after adjustment for changes in body mass index (P = 0.46).
CONCLUSION


Treatment with liraglutide for 26 weeks was associated with a reduction in cardiac adipose tissue compared to placebo. The reduction was not independent of weight loss, suggesting that this is not a drug-specific effect.",2021,"At baseline, the mean (SD) cardiac adipose tissue volume was comparable between the liraglutide and the placebo group [232.6 (112.8) vs 227.0 (103.2) ml, p = 0.80].","['type 2 diabetes', 'Type 2', 'A total of 102 participants', 'Participants with type 2 diabetes', 'Diabetes']","['liraglutide', 'Placebo', 'Liraglutide', 'placebo', 'liraglutide 1.8\xa0mg/day or placebo']","['cardiac adipose tissue', 'Mean change in body weight', 'mean (SD) cardiac adipose tissue volume', 'mean cardiac adipose tissue change', 'weight-loss']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",102.0,0.659525,"At baseline, the mean (SD) cardiac adipose tissue volume was comparable between the liraglutide and the placebo group [232.6 (112.8) vs 227.0 (103.2) ml, p = 0.80].","[{'ForeName': 'Ida K B', 'Initials': 'IKB', 'LastName': 'Rasmussen', 'Affiliation': 'Steno Diabetes Centre Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Emilie H', 'Initials': 'EH', 'LastName': 'Zobel', 'Affiliation': 'Steno Diabetes Centre Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Rasmus S', 'Initials': 'RS', 'LastName': 'Ripa', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, Kobenhavn, Denmark.'}, {'ForeName': 'Bernt J', 'Initials': 'BJ', 'LastName': 'von Scholten', 'Affiliation': 'Steno Diabetes Centre Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Viktor R', 'Initials': 'VR', 'LastName': 'Curovic', 'Affiliation': 'Steno Diabetes Centre Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Jacob K', 'Initials': 'JK', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, Kobenhavn, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kjaer', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, Kobenhavn, Denmark.'}, {'ForeName': 'Tine W', 'Initials': 'TW', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Centre Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Centre Copenhagen, Gentofte, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14516']
1090,34387258,The Impact of Tape Sealing Face Masks on Visual Field Scores in the Era of COVID-19: A Randomized Cross-over Study.,"PRECIS


Tape sealing of the face mask can prevent fogging artifacts of visual field testing. Here, we demonstrate that tape sealing can improve visual field scores even when fogging artifacts are not obvious.
PURPOSE


The purpose of this study was to demonstrate that visual field scores improve when the face masks are taped to prevent fogging artifacts.
METHODS


A Single-center, randomized 2×2 cross-over study. Twenty-six visual fields of 13 patients of the glaucoma outpatient clinic were included. Patients were randomized in either sequence 1 (Octopus visual field examination without tape sealing, followed by examination with tape sealing) or sequence 2 (examination with, followed by without tape sealing).
RESULTS


The results for mean defect and square root of loss variance differ significantly in the examination with and without tape sealing [mean difference (without-with) 0.39 dB, 95% confidence interval: 0.07-0.70 dB, P=0.018 and 0.49 dB, 95% confidence interval: 0.19-0.79 dB, P=0.003, respectively]. There was no sequence effect (P=0.967) for mean defect nor the square root of loss variance (P=0.779). A significant effect for period (P=0.023) for mean defect was yielded.
CONCLUSION


Tape sealing of face masks during visual field testing prevented fogging artifacts and improved visual field scores even when fogging artifacts were not obvious and should be considered in clinical practice.",2021,There was no sequence effect (P=0.967) for mean defect nor sLV (P=0.779).,['Twenty-six visual fields of 13 patients of the glaucoma outpatient clinic were included'],"['Tape Sealing Face Masks', 'sequence 1 (Octopus visual field examination without tape sealing, followed by examination with tape sealing) or sequence 2 (examination with, followed by without tape sealing', 'tape sealing']","['mean defect and square root of Loss Variance (sLV', 'visual field scores', 'Visual Field Scores']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0028831', 'cui_str': 'Octopus'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C1719837', 'cui_str': 'Loss variance'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",26.0,0.0890133,There was no sequence effect (P=0.967) for mean defect nor sLV (P=0.779).,"[{'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Heidinger', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Falb', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Werkl', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'List', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hoeflechner', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Riedl', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Graz.'}, {'ForeName': 'Domagoj', 'Initials': 'D', 'LastName': 'Ivastinovic', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Hommer', 'Affiliation': 'Department of Ophthalmology, Sanatorium Hera, Vienna, Austria.'}, {'ForeName': 'Ewald', 'Initials': 'E', 'LastName': 'Lindner', 'Affiliation': 'Department of Ophthalmology.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001922']
1091,33823028,Using Treatment Fidelity Measures to Understand Walking Recovery: A Secondary Analysis From the Community Ambulation Project.,"OBJECTIVES


Physical therapist intervention studies can be deemed ineffective when, in fact, they may not have been delivered as intended. Measurement of treatment fidelity (TF) can address this issue. The purpose of this study was to describe TF of a home-based intervention, identify factors associated with TF, and examine whether components of TF were associated with the outcome of change in 6-minute walk distance (∆6MWD).
METHODS


This is a secondary analysis of community-dwelling hip fracture participants who completed standard therapy and were randomly assigned to the active intervention (Push). Push was 16 weeks of lower extremity strengthening, function, and endurance training. TF was defined as delivery (attendance rate, exercise duration) and receipt (progression in training load, heart rate reserve [HRR] during endurance training, and exercise position [exercise on floor]). The outcome was ∆6MWD. Independent variables included baseline (demographic and clinical) measures. Descriptive statistics were calculated; linear and logistic regressions were performed.
RESULTS


Eighty-nine participants were included in this analysis; 59 (66%) had attendance of 75% or greater. Participants walked for 20 minutes or more for 78% of sessions. The average training load increased by 22%; the mean HRR was 35%; and 61 (69%) participants exercised on the floor for at least 75% of sessions. Regression analyses showed that a higher body mass index and greater baseline 6MWD were related to components of TF; 4 out of 5 components of TF were significantly related to ∆6MWD. The strongest TF relationship showed that those who exercised on the floor improved by 62 m (95% CI = 31-93 m) more than those who did not get on the floor.
CONCLUSIONS


Measures of TF should extend beyond attendance rate. This analysis demonstrates how measures of TF, including program attendance, progression in training load, endurance duration, and exercising on the floor were significantly related to improvement in 6MWD in participants post hip fracture.
IMPACT


This careful analysis of treatment fidelity assured that the intervention was delivered and received as intended. Analysis of data from a large trial with participants after hip fracture showed that regular attendance, frequent endurance training for 20 minutes, increases in lower extremity training loads, and exercising on the floor were associated with improvements in the outcome of 6-minute-walk distance. The strongest association with improvement was exercising on the floor.",2021,The average training load increased by 22%; the mean HRR was 35%; and 61 (69%) participants exercised on the floor ≥75% of sessions.,"['community-dwelling hip fracture participants who completed', 'participants post hip fracture', '89 participants were included in this analysis; 59 (66%) had attendance ≥75']","['standard therapy', 'active intervention (Push']","['mean HRR', '6-minute walk distance (∆6MWD', 'lower extremity training loads, and exercising on the floor', 'delivery (attendance rate, exercise duration) and receipt (progression in training load, heart rate reserve (HRR) during endurance training, and exercise position (exercise on floor', 'higher body mass index (BMI) and greater baseline 6MWD', 'strongest TF relationship', 'Walking Recovery', 'average training load']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0580841', 'cui_str': 'Does push'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",89.0,0.0472988,The average training load increased by 22%; the mean HRR was 35%; and 61 (69%) participants exercised on the floor ≥75% of sessions.,"[{'ForeName': 'Kathleen K', 'Initials': 'KK', 'LastName': 'Mangione', 'Affiliation': 'Department of Physical Therapy, Arcadia University, 450 S Easton Rd, Glenside, Pennsylvania, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Posner', 'Affiliation': 'Department of Mathematics and Statistics, Villanova University, Villanova, Pennsylvania, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Craik', 'Affiliation': 'College of Health Science, Department of Physical Therapy, Arcadia University, Glenside, Pennsylvania, USA.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Wolff', 'Affiliation': 'Department of Computer Science and Mathematics, Arcadia University, Glenside, Pennsylvania, USA.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Fortinsky', 'Affiliation': 'UConn Center on Aging, University of Connecticut School of Medicine, Farmington, Connecticut, USA.'}, {'ForeName': 'Brock A', 'Initials': 'BA', 'LastName': 'Beamer', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Ellen F', 'Initials': 'EF', 'LastName': 'Binder', 'Affiliation': 'Division of Geriatrics and Nutritional Science, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Denise L', 'Initials': 'DL', 'LastName': 'Orwig', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Magaziner', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Resnick', 'Affiliation': 'School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}]",Physical therapy,['10.1093/ptj/pzab109']
1092,33825498,Conventional-Dose CT Versus 2-mSv CT for Right Colonic Diverticulitis as an Alternate Diagnosis of Appendicitis: Secondary Analysis of Large Pragmatic Randomized Trial Data.,"BACKGROUND.  Adoption of low-dose CT for the diagnosis of appendicitis has been slow in children and in adults, partly because of concern about missing alternative diagnoses including right colonic diverticulitis.  OBJECTIVE.  The purpose of our study was to retrospectively compare the diagnostic performance of IV contrast-enhanced 2-mSv and conventional-dose CT (CDCT) for the diagnosis of right colonic diverticulitis in adolescents and young adults with suspected appendicitis.  METHODS.  This post hoc analysis of a prospective randomized controlled trial included 3074 patients (1672 female patients and 1402 male patients) ranging in age from 15 to 44 years old (mean ± SD, 28 ± 9 years) from 20 hospitals. From December 2013 to August 2016, patients were randomized to either the 2-mSv CT group ( n  = 1535 patients) or the CDCT (median, 7 mSv) group ( n  = 1539 patients). A total of 161 radiologists prospectively issued CT reports in which they suggested alternative diagnoses for 976 (2-mSv CT) and 924 (CDCT) patients. Seven independent assessors adjudicated final diagnoses on the basis of clinical and CT findings. Endpoints of test-positives, test-negatives, sensitivity, and specificity for right colonic diverticulitis were compared using chi-square and Mann-Whitney  U  tests. Characteristics and disposition of patients with test-positive results were assessed. Four readers retrospectively reviewed CT images of 400 patients selected from the trial (113 and 108 patients with diverticulitis from 2-mSv CT and CDCT groups, respectively) to evaluate interobserver agreement for right colonic diverticulitis in terms of Gwet coefficients.  RESULTS.  Between-group differences were minute for most endpoints related to right colonic diverticulitis: test-positives (difference, 0.2% [95% CI, -1.8% to 2.1%]; 7.8% [119/1535 patients] vs 7.6% [117/1539 patients];  p  = .93), test-negatives (0.5% [95% CI, -1.5% to 2.5%]; 91.7% [1407/1535] vs 91.2% [1403/1539];  p  = .67), sensitivity (0% [95% CI, -6% to 6%]; 95% [110/116] vs 95% [105/111];  p >  .99), and specificity (0.3% [95% CI, -0.5% to 0.9%]; 99.4% [1401/1410] vs 99.1% [1397/1409];  p  = .66). The characteristics and disposition of test-positive patients were similar between the two groups. Gwet coefficients were high and comparable between the two groups (2-mSv CT vs CDCT, 0.849 vs 0.889;  p  = .20).  CONCLUSION.  Two-millisievert CT is comparable to conventional-dose CT for the diagnosis of right colonic diverticulitis.  CLINICAL IMPACT.  By mitigating concern about a missed diagnosis of right colonic diverticulitis, the results further support the use of low-dose CT in patients with suspected appendicitis.  TRIAL REGISTRATION.  ClinicalTrials.gov NCT01925014.",2021,"Results:  Between-group differences were minute for most endpoints related to right colonic diverticulitis: test-positives (difference [95% CI], 0.2% [-1.8%, 2.1%]; 7.8% [119/1535] vs 7.6% [117/1539]; P = .93), test-negatives (0.5% [-1.5%, 2.5%]; 91.7% [1407/1535] vs 91.2% [1403/1539]; P = .67), sensitivity (0% [-6%, 6%]; 95% [110/116] vs 95% [105/111]; P > .99), and specificity (0.2% [-0.5%, 0.9%]; 99.4% [1401/1410] vs 99.1% [1397/1409]; P = .66).","['adolescents and young adults with suspected appendicitis', 'Appendicitis', '3074 patients ranging 15-44 years old (28 ± 9 years; 1672 women, 1402 men) from 20 hospitals, randomized into 2-mSv (n = 1535) or CDCT (median, 7 mSv; n = 1539) groups from December 2013 to August 2016', 'A total of 161 radiologists prospectively issued CT reports in which they suggested alternative diagnoses in 976 (2-mSV CT) and 924 (CDCT) patients', 'patients with suspected appendicitis', 'Four readers retrospectively reviewed CT images of 400 patients selected from the trial (113 and 108 with diverticulitis from 2-mSv CT and CDCT groups, respectively']","['IV contrast-enhanced 2-mSv and conventional-dose CT (CDCT', '2-mSv CT', 'Two Millisievert Versus Conventional-Dose CT', 'low-dose CT']","['right colonic diverticulitis: test-positives', 'specificity', 'test-negatives', 'diagnostic performance', 'sensitivity', 'test-positives, test-negatives, sensitivity, and specificity for right colonic diverticulitis']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0560133', 'cui_str': 'mSv'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0012814', 'cui_str': 'Diverticulitis of colon'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",3074.0,0.0707888,"Results:  Between-group differences were minute for most endpoints related to right colonic diverticulitis: test-positives (difference [95% CI], 0.2% [-1.8%, 2.1%]; 7.8% [119/1535] vs 7.6% [117/1539]; P = .93), test-negatives (0.5% [-1.5%, 2.5%]; 91.7% [1407/1535] vs 91.2% [1403/1539]; P = .67), sensitivity (0% [-6%, 6%]; 95% [110/116] vs 95% [105/111]; P > .99), and specificity (0.2% [-0.5%, 0.9%]; 99.4% [1401/1410] vs 99.1% [1397/1409]; P = .66).","[{'ForeName': 'Hae Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Korea.'}, {'ForeName': 'Seungjae', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Applied Bioengineering, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Dong Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': ""Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Yousun', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'Biomedical Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Korea.'}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Ko', 'Affiliation': 'Department of Radiology, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Seok Min', 'Initials': 'SM', 'LastName': 'Jeong', 'Affiliation': 'Department of Radiology, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Sung Bin', 'Initials': 'SB', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyoung Ho', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AJR. American journal of roentgenology,['10.2214/AJR.21.25584']
1093,33826591,Complications and Revision Rates in Minimally Invasive Robotic-Guided Versus Fluoroscopic-Guided Spinal Fusions: The MIS ReFRESH Prospective Comparative Study.,"STUDY DESIGN


Prospective, multicenter, partially randomized.
OBJECTIVE


Assess rates of complications, revision surgery, and radiation between Mazor robotic-guidance (RG) and fluoro-guidance (FG).
SUMMARY OF BACKGROUND DATA


Minimally invasive surgery MIS ReFRESH is the first study designed to compare RG and FG techniques in adult minimally invasive surgery (MIS) lumbar fusions.
METHODS


Primary endpoints were analyzed at 1 year follow-up. Analysis of variables through Cox logistic regression and a Kaplan-Meier Survival Curve of surgical complications.
RESULTS


Nine sites enrolled 485 patients: 374 (RG arm) and 111 (FG arm). 93.2% of patients had more than 1 year f/u. There were no differences for sex, Charlson Comorbidity Index, diabetes, or tumor. Mean age of RG patients was 59.0 versus 62.5 for FG (P = 0.009) and body mass index (BMI) was 31.2 versus 28.1 (P< 0.001). Percentage of smokers was almost double in the RG (15.2% vs. 7.2%, P = 0.029). Surgical time was similar (skin-to-skin time/no. of screws) at 24.9 minutes RG and 22.9 FG (P = 0.550). Fluoroscopy during surgery/no. of screws was 15.5 seconds RG versus 35.4 seconds FG, (15 seconds average reduction). Fluoroscopy time during instrumentation/no. of screws was 3.6 seconds RG versus 17.8 seconds FG showing an 80% average reduction of fluoro time/screw in RG (P < 0.001). Within 1 year follow-up, there were 39 (10.4%) surgical complications RG versus 39 (35.1%) FG, and 8 (2.1%) revisions RG versus 7 (6.3%) FG. Cox regression analysis including age, sex, BMI, CCI, and no. of screws, demonstrated that the hazard ratio (HR) for complication was 5.8 times higher FG versus RG (95% CI: 3.5-9.6, P < 0.001). HR for revision surgery was 11.0 times higher FG versus RG cases (95% CI 2.9-41.2, P < 0.001).
CONCLUSION


Mazor robotic-guidance was found to have a 5.8 times lower risk of a surgical complication and 11.0 times lower risk for revision surgery. Surgical time was similar between groups and robotic-guidance reduced fluoro time per screw by 80% (approximately 1 min/case).Level of Evidence: 2.",2021,FG showing an 80% average reduction of fluoro time/screw in RG (p < 0.001).,"['adult MIS lumbar fusions', '9 sites enrolled 485 patients: 374 (RG arm) and 111 (FG arm']","['Minimally Invasive Robotic-Guided Versus Fluoroscopic-Guided Spinal Fusions', 'Mazor robotic-guidance (RG) and fluoro-guidance (FG']","['fluoro time per screw', 'Complications and Revision Rates', 'HR for revision surgery', 'BMI', 'Fluoroscopy time', 'Hazard Ratio (HR) for complication', 'Surgical time', 'fluoro time/screw in RG', 'gender, Charlson Comorbidity Index, diabetes, or tumor']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",485.0,0.130207,FG showing an 80% average reduction of fluoro time/screw in RG (p < 0.001).,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Good', 'Affiliation': 'Virginia Spine Institute, Reston, VA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Orosz', 'Affiliation': 'National Spine Health Foundation, Reston, VA.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Schroerlucke', 'Affiliation': 'Tabor Orthopedics, Memphis, TN.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cannestra', 'Affiliation': 'Lyerly Neurosurgery, Jacksonville, FL.'}, {'ForeName': 'Jae Y', 'Initials': 'JY', 'LastName': 'Lim', 'Affiliation': 'Atlantic Brain and Spine, Reston, VA.'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Hsu', 'Affiliation': 'Rothman Institute, Abington, PA.'}, {'ForeName': 'Faissal', 'Initials': 'F', 'LastName': 'Zahrawi', 'Affiliation': 'Department of Orthopedic Surgery, Florida Hospital, Celebration, FL.'}, {'ForeName': 'Hunaldo J', 'Initials': 'HJ', 'LastName': 'Villalobos', 'Affiliation': 'Central Florida Neurosurgery Institute, Osceola, FL.'}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Ramirez', 'Affiliation': 'Central Florida Neurosurgery Institute, Osceola, FL.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sweeney', 'Affiliation': 'Southeastern Spine Center & Research Institute, Sarasota, FL.'}, {'ForeName': 'Michael Y', 'Initials': 'MY', 'LastName': 'Wang', 'Affiliation': 'Department of Neurological Surgery, University of Miami Hospital, Miami, FL.'}]",Spine,['10.1097/BRS.0000000000004048']
1094,34384772,Further implications from a pragmatic randomized clinical trial of gestational diabetes screening: per-protocol and as-treated estimates.,,2021,,[],[],[],[],[],[],,0.2415,,"[{'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Hillier', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N Interstate Ave., Portland, OR 97227; Center for Integrated Health Care Research, Kaiser Permanente Hawaii, Honolulu, HI. Electronic address: Teresa.Hillier@kpchr.org.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Pedula', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR; Hawaii Permanente Medical Group, Kaiser Permanente, Honolulu, HI.'}, {'ForeName': 'Keith K', 'Initials': 'KK', 'LastName': 'Ogasawara', 'Affiliation': 'Division of Perinatology, Department of Obstetrics and Gynecology, Hawaii Permanente Medical Group, Kaiser Permanente, Honolulu, HI.'}, {'ForeName': 'Kimberly K', 'Initials': 'KK', 'LastName': 'Vesco', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR.'}, {'ForeName': 'Caryn E S', 'Initials': 'CES', 'LastName': 'Oshiro', 'Affiliation': 'Center for Integrated Health Care Research, Kaiser Permanente Hawaii, Honolulu, HI.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Lubarsky', 'Affiliation': 'Division of Perinatology, Department of Obstetrics and Gynecology, Northwest Permanente, Kaiser Permanente, Clackamas, OR.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Van Marter', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.08.006']
1095,34384742,Cardiovascular risk and outcomes in symptomatic patients with suspected coronary artery disease and non coronary vascular disease: A report from the PROMISE trial.,"BACKGROUND


Non-coronary vascular disease (NCVD) is associated with adverse cardiovascular events. Little is known about physician risk assessment, prevalence of coronary artery disease (CAD), cardiac catheterization, and the performance of the atherosclerotic cardiovascular disease (ASCVD) risk score in patients with NCVD.
METHODS


Retrospective analysis of outpatients with angina and no known CAD from the PROMISE trial. NCVD included carotid artery stenosis ≥50%, or history of stroke or peripheral artery disease. Multivariable models of physician estimates of the probability of obstructive CAD, prevalence of non-obstructive and obstructive CAD, referral to cardiac catheterization, and all-cause death/myocardial infarction/unstable angina were performed.
RESULTS


Among 10,001 patients in the PROMISE trial, 379 (3.8%) patients had NCVD. Only 8.5% of participants with NCVD were categorized as high-risk for obstructive CAD by physicians, though 15.5% (25/161) had obstructive CAD in those randomized to coronary computed tomography (CTA). NCVD was independently associated with non-obstructive (aOR = 1.58; 95% CI 1.18-2.61; P = .006) but not obstructive CAD by CTA. Adjusted referral to cardiac catheterization was similar with and without NCVD (aOR 1.04; 95% CI 0.88-1.94, P = .19). NCVD was associated with an increased risk of all-cause death/MI/UA (aOR 2.03; 95% CI 1.37-3.01, P < .001). There was no interaction between NCVD status and ASCVD risk score.
CONCLUSIONS


Among patients with NCVD and angina, NCVD had increased adjusted risks of CAD and adverse outcomes which were not well described by ASCVD risk score and were underrecognized by physicians. Increased awareness and better risk stratification tools for patients with NCVD may be necessary to recognize the associated CV risk and optimize diagnostic testing and therapies.",2021,NCVD was independently associated with non-obstructive (aOR = 1.58; 95% CI 1.18 - 2.61; p=0.006) but not obstructive CAD by CTA.,"['10,001 patients in the PROMISE trial, 379 (3.8%) patients had NCVD', 'outpatients with angina and no known CAD from the PROMISE trial', 'patients with NCVD', 'Symptomatic Patients with Suspected CAD and Non Coronary Vascular Disease']",['NCVD'],"['Cardiovascular Risk and Outcomes', 'ASCVD risk score', 'probability of obstructive CAD, prevalence of non-obstructive and obstructive CAD, referral to cardiac catheterization, and all-cause death/myocardial infarction/unstable angina', 'NCVD', 'carotid artery stenosis ≥ 50%, or history of stroke or peripheral artery disease', 'Adjusted referral to cardiac catheterization', 'NCVD status and ASCVD risk score', 'risk of all-cause death/MI/UA', 'adjusted risks of CAD and adverse outcomes', 'obstructive CAD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",10001.0,0.29888,NCVD was independently associated with non-obstructive (aOR = 1.58; 95% CI 1.18 - 2.61; p=0.006) but not obstructive CAD by CTA.,"[{'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Vemulapalli', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC. Electronic address: sreekanth.vemulapalli@duke.edu.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stebbins', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'J Antonio', 'Initials': 'JA', 'LastName': 'Gutierrez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Dolor', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Pellikka', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic School of Medicine, Rochester, MN.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Alhanti', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2021.07.010']
1096,33838565,Prospective association between baseline plasma zinc concentration and development of proteinuria in Chinese hypertensive patients.,"OBJECTIVE


We aimed to evaluate the association between baseline plasma zinc and the development of proteinuria as well as possible effect modifiers in hypertensive patients.
METHODS


This is a subset of the China Stroke Primary Prevention Trial (CSPPT) Renal Sub-Study. In the CSPPT, participants were randomized to receive a daily oral dose of 1 tablet containing 10 mg enalapril and 0.8 mg folic acid or 1 tablet containing 10 mg enalapril only. A total of 783 participants with plasma zinc measurements and without proteinuria at baseline were included in the current study. The study outcome was the development of proteinuria during the follow-up, defined as a urine dipstick reading of trace or ≥1+ at the exit visit.
RESULTS


During a median follow-up duration of 4.4 years, the development of proteinuria occurred in 93 (11.9 %) participants. There was an inverse relation of baseline plasma zinc with the development of proteinuria (per SD increment; OR, 0.74, 95 % CI: 0.55-0.99), p for trend of quartiles = 0.005.
CONCLUSIONS


In Chinese hypertensive patients, there was a significant inverse association between baseline plasma zinc and the development of proteinuria, although plasma zinc remained in the reference range.",2021,"There was an inverse relation of baseline plasma zinc with the development of proteinuria (per SD increment; OR, 0.74, 95 % CI: 0.55-0.99), p for trend of quartiles = 0.005.
","['783 participants with plasma zinc measurements and without proteinuria at baseline were included in the current study', 'hypertensive patients', 'Chinese hypertensive patients']","['enalapril', 'enalapril and 0.8 mg folic acid']","['development of proteinuria', 'baseline plasma zinc and the development of proteinuria, although plasma zinc', 'development of proteinuria during the follow-up, defined as a urine dipstick reading of trace or ≥1+ at the exit visit']","[{'cui': 'C0729827', 'cui_str': 'Plasma zinc measurement'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0337094', 'cui_str': 'Exit'}]",783.0,0.263757,"There was an inverse relation of baseline plasma zinc with the development of proteinuria (per SD increment; OR, 0.74, 95 % CI: 0.55-0.99), p for trend of quartiles = 0.005.
","[{'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China.'}, {'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China; Institute of Biomedicine, Anhui Medical University, Hefei, 230032, China.'}, {'ForeName': 'Chengzhang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Institute of Biomedicine, Anhui Medical University, Hefei, 230032, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute of Biomedicine, Anhui Medical University, Hefei, 230032, China; Shenzhen Evergreen Medical Institute, Shenzhen, 518057, China.'}, {'ForeName': 'Huiyuan', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205-2179, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China; Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China. Electronic address: xipingxu126@126.com.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China. Electronic address: pharmaqin@126.com.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2021.126755']
1097,33839207,Establishment and validation of a prognostic nomogram to predict early metastasis in nasopharyngeal carcinoma patients within six months after radiotherapy and to guide intensive treatment.,"PURPOSE


This study aimed to establish an effective prognostic nomogram to predict the risk of early metastasis (EM) in nasopharyngeal carcinoma (NPC) patients, as a guide for intensive treatment.
MATERIALS AND METHODS


A total of 9021 patients with biopsy-confirmed NPC at our institute were enrolled in this study between December 2006 to December 2016. We randomized these patients using a proportion of 2/3 and 1/3 and selected 6044 and 2977 patients as the training and validation cohorts, respectively. All patients received radiotherapy with or without chemotherapy. Univariate and multivariate logistical regressions were used to identify independent risk factors. The nomogram's predictive value was evaluated by concordance indexes (C-indexes), calibration curves, probability density functions (PDFs), and clinical utility curves (CUCs). ROC analysis using Delong test was used to compare efficiency between the nomogram and other risk factors.
RESULTS


In total, 174 (2.9%) and 81 (2.7%) patients in training and validation cohorts, respectively, had EM. Pretreatment plasma EBV DNA, N stage, LDH, ALP, BMI, and sex were independent predictive factors of EM. The C-indexes of nomogram were 0.756 (95% CI = 0.719-0.793) and 0.766 (95% CI = 0.720-0.813), in the training and validation cohorts, respectively. The C-index of the nomogram was significantly superior to any one of independent factors. According to the PDFs and CUCs and considering the balance of the true positive EM patients and true positive non-EM patients, we chose 5.0% as a threshold probability for clinical decision-making, which could distinguish about 85% and 48% of non-EM and EM patients, respectively.
CONCLUSION


Our nomogram had good accuracy in predicting EM incidence, and a 5.0% threshold was appropriate for clinical decision-making.",2021,"The nomogram's predictive value was evaluated by concordance indexes (C-indexes), calibration curves, probability density functions (PDFs), and clinical utility curves (CUCs).","['nasopharyngeal carcinoma (NPC) patients', 'nasopharyngeal carcinoma patients within six months after', 'patients using a proportion of 2/3 and 1/3 and selected 6044 and 2977 patients as the training and validation cohorts, respectively', '9021 patients with biopsy-confirmed NPC at our institute were enrolled in this study between December 2006 to December 2016']","['radiotherapy with or without chemotherapy', 'radiotherapy']","['Pretreatment plasma EBV DNA, N stage, LDH, ALP, BMI, and sex', 'concordance indexes (C-indexes), calibration curves, probability density functions (PDFs), and clinical utility curves (CUCs']","[{'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369169', 'cui_str': 'Epstein-Barr virus DNA'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",9021.0,0.0161033,"The nomogram's predictive value was evaluated by concordance indexes (C-indexes), calibration curves, probability density functions (PDFs), and clinical utility curves (CUCs).","[{'ForeName': 'Zi-Jian', 'Initials': 'ZJ', 'LastName': 'Lu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: luzj@sysucc.org.cn.'}, {'ForeName': 'Li-Ting', 'Initials': 'LT', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: liult@sysucc.org.cn.'}, {'ForeName': 'Xue-Song', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: sunxs@sysucc.org.cn.'}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Guo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: guoshsh@sysucc.org.cn.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: yangqi@sysucc.org.cn.'}, {'ForeName': 'Sai-Lan', 'Initials': 'SL', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: liusl@sysucc.org.cn.'}, {'ForeName': 'Xiao-Yun', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: lixy1@sysucc.org.cn.'}, {'ForeName': 'Hui-Zhi', 'Initials': 'HZ', 'LastName': 'Qiu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: qiuhz@sysucc.org.cn.'}, {'ForeName': 'Zhen-Chong', 'Initials': 'ZC', 'LastName': 'Yang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: yangzc@sysucc.org.cn.'}, {'ForeName': 'Bei-Bei', 'Initials': 'BB', 'LastName': 'Xiao', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: xiaobb@sysucc.org.cn.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: linchao@sysucc.org.cn.'}, {'ForeName': 'Dong-Hua', 'Initials': 'DH', 'LastName': 'Luo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: luodh@sysucc.org.cn.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: sunrui@sysucc.org.cn.'}, {'ForeName': 'Huan-Xin', 'Initials': 'HX', 'LastName': 'Lin', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: linhx@sysucc.org.cn.'}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: chenqy@sysucc.org.cn.'}, {'ForeName': 'Lin-Quan', 'Initials': 'LQ', 'LastName': 'Tang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: tanglq@sysucc.org.cn.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: guoling@sysucc.org.cn.'}, {'ForeName': 'Hai-Qiang', 'Initials': 'HQ', 'LastName': 'Mai', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, PR China. Electronic address: maihq@sysucc.org.cn.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.03.035']
1098,33844408,Epigastric symptom response to low FODMAP dietary advice compared with standard dietetic advice in individuals with functional dyspepsia.,"BACKGROUND


Certain dietary constituents may provoke symptoms of functional dyspepsia (FD); however, there is an absence of dietary trials testing specific dietary interventions. Empirically derived dietary strategies and the low FODMAP diet are frequently used in practice. This study aimed to compare the effectiveness of low FODMAP dietary advice with standard dietary advice for reducing epigastric and overall gastrointestinal symptoms in individuals with FD.
METHODS


Data were collected from 59 consecutive eligible individuals with FD attending an initial and review outpatient dietetic consultation at Princess Alexandra Hospital. Of these, 40 received low FODMAP advice and 19 received standard dietary advice. As part of usual care, the Structured Assessment of Gastrointestinal Symptom Scale (SAGIS) was used to assess epigastric (maximum score = 28) and overall gastrointestinal symptoms (maximum score = 88). Dietary adherence data were collected, and change in symptom score and proportion of responders (defined as a ≥30% reduction in score) for epigastric and total symptoms was calculated.
KEY RESULTS


Most individuals (48/59, 81%) had FD and coexisting irritable bowel syndrome. There was a greater reduction in epigastric score in those receiving low FODMAP dietary advice compared with those receiving standard advice (est. marginal mean [95% CI]: -3.6 [-4.9, -2.2] vs. -0.9 [-2.9, 1.1], p = 0.032) and total symptom score (-9.4 [-12.4, -6.4] vs. -3.3 [-7.7, 1.1] p = 0.026). A greater proportion receiving low FODMAP dietary advice were responders versus those receiving standard advice (50% vs. 16%, p = 0.012). Dietary adherence did not differ between groups (p = 0.497).
CONCLUSIONS & INFERENCES


The low FODMAP diet appears more effective for improving epigastric symptoms in people with FD compared with standard advice. A randomized controlled trial is required to substantiate these findings.",2021,The low FODMAP diet appears more effective for improving epigastric symptoms in people with FD compared with standard advice.,"['individuals with functional dyspepsia', 'individuals with FD', '59 consecutive eligible individuals with FD attending an initial and review outpatient dietetic consultation at Princess Alexandra Hospital']","['low FODMAP dietary advice with standard dietary advice', 'low FODMAP dietary advice', 'standard dietetic advice', 'low FODMAP advice and 19 received standard dietary advice']","['Epigastric symptom response', 'Dietary adherence', 'epigastric and total symptoms', 'epigastric and overall gastrointestinal symptoms', 'FD and coexisting irritable bowel syndrome', 'epigastric score', 'total symptom score', 'Gastrointestinal Symptom Scale (SAGIS', 'overall gastrointestinal symptoms', 'Dietary adherence data', 'epigastric symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0401706,The low FODMAP diet appears more effective for improving epigastric symptoms in people with FD compared with standard advice.,"[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Staudacher', 'Affiliation': 'Department of Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Nevin', 'Affiliation': 'Department of Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Duff', 'Affiliation': 'Department of Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Kendall', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Holtmann', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14148']
1099,33843404,Efficiency of topical rifampin on infection in open neural tube defects: a randomized controlled trial.,"OBJECTIVES


Neural tube defects are the second most common congenital malformation in humans. Despite significant decreases in neural tube defects and related mortality and morbidity with recent developments, infections remain an important problem. Research on the role of topical therapy for managing neural tube defects and associated infections in the neonatal period has been limited. This randomized controlled trial aimed to investigate the efficiency of topical Rifampin on infection control in paraplegic newborns with open neural tube defects.
METHODS


Thirty-seven patients who underwent an operation for neural tube defects were included. Topical Rifampin and cefotaxime were administered to 19 patients constituting the case group and local saline and cefotaxime were administered to a control group. Patients were examined for ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, and sepsis.
RESULTS


None of the patients using topical rifampin had ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, or sepsis. In the control group, ventriculoperitoneal shunt infection/dysfunction was found in 4 (22.2%) cases, surgical site infection in 3 (27.7%), urinary tract infection in 3 (27.7%), and sepsis in 5 (27.7%), with statistically significant differences between the groups ( p  = 0.01,  p  = 0.032,  p  = 0.032, and  p  = 0.002, respectively). No local or systemic side effect was observed regarding rifampin use.
CONCLUSION


Topical Rifampin is effective in minimizing complications like sepsis, surgical site infection, urinary tract infection, and ventriculoperitoneal shunt infection due to neural tube defect operations. Further research with larger numbers of cases is needed to implement this practice routinely.",2021,"None of the patients using topical rifampin had ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, or sepsis.","['19 patients constituting the case group and', 'Thirty-seven patients who underwent an operation for neural tube defects were included', 'paraplegic newborns with open neural tube defects', 'Open Neural Tube Defects']","['local saline and cefotaxime', 'topical Rifampin', 'Topical Rifampin and cefotaxime', 'topical rifampin', 'Topical Rifampin']","['sepsis', 'surgical site infection', 'ventriculoperitoneal shunt infection/dysfunction', 'urinary tract infection', 'local or systemic side effect', 'ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, or sepsis', 'neural tube defects and related mortality and morbidity', 'ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, and sepsis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027794', 'cui_str': 'Neural tube defect'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0857021', 'cui_str': 'Paraplegic'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0007554', 'cui_str': 'Cefotaxime'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0162702', 'cui_str': 'Ventriculoperitoneal shunt'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027794', 'cui_str': 'Neural tube defect'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",37.0,0.105274,"None of the patients using topical rifampin had ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, or sepsis.","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Deger', 'Affiliation': 'Department of Pediatric, Division of Neonatology, Dicle University School of Medicine, Diyarbakir, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Başaranoğlu', 'Affiliation': 'Department of Pediatric, Division of Neonatology, University of Health Sciences, Van, Turkey.'}, {'ForeName': 'Nihat', 'Initials': 'N', 'LastName': 'Demir', 'Affiliation': 'Department of Pediatric, Division of Neonatology, Esenyurt Private Hospital, İstanbul, Turkey.'}, {'ForeName': 'Abdurrahman', 'Initials': 'A', 'LastName': 'Aycan', 'Affiliation': 'Faculty of Medicine, Department of Neurosurgery, Yuzuncu Yıl University, Van, Turkey.'}, {'ForeName': 'Oğuz', 'Initials': 'O', 'LastName': 'Tuncer', 'Affiliation': 'Faculty of Medicine, Division of Neonatology, Yuzuncu Yıl University, Van, Turkey.'}]",The International journal of neuroscience,['10.1080/00207454.2021.1909583']
1100,33853021,Identifying treatment moderators of a trauma-informed parenting intervention with children in foster care: Using model-based recursive partitioning.,"BACKGROUND


Trauma-informed parenting interventions have been used in child welfare to help caregivers respond to children in trauma-informed ways that can mitigate the effects of maltreatment and build strong caregiver-child relationships. Existing studies support their effectiveness with children and youth involved in the child welfare system. However, to further advance the effectiveness of evidenced-based intervention for child welfare populations, one key step is to identify subgroups of individuals who have different intervention responses or outcomes.
OBJECTIVE


To identify pre-treatment moderators that can distinguish subgroups of caregivers and children who benefit differently from an intervention.
PARTICIPANTS AND SETTING


414 children in foster care (age 3 or younger) and their caregivers (birth, adoptive, kin, and nonkin) were randomly assigned to receive a trauma-informed parenting intervention in the Illinois Birth through Three Title IV-E waiver demonstration or foster care services as usual.
METHODS


Model-based Recursive Partitioning (MOB) was used to identify treatment moderators and moderator interactions. MOB fits a parametric model and uses a data-driven method to find subgroups for which the specified parametric model has different parameters. Two parametric models (logistic and linear regression) were used in accordance with two outcomes: reunification (binary) and caregiver-child attachment (continuous). We examined 21 potential pre-treatment moderators in both models.
RESULTS


For the reunification outcome, the MOB produced the following three treatment moderators, which identified subgroups of participants who responded differently to the intervention: (a) caregivers' relationship with the child (kin vs. non-kin/permanent caregivers), (b) caregiver-child attachment, and (c) case history of physical abuse. For the attachment outcome, caregivers' age was found to be a treatment moderator. Future developments of trauma-informed interventions should consider these moderators.",2021,"For the reunification outcome, the MOB produced the following three treatment moderators, which identified subgroups of participants who responded differently to the intervention: (a) caregivers' relationship with the child (kin vs. non-kin/permanent caregivers), (b) caregiver-child attachment, and (c) case history of physical abuse.","['caregivers and children who benefit differently from an intervention', '414 children in foster care (age 3 or younger) and their caregivers (birth, adoptive, kin, and nonkin']","['trauma-informed parenting intervention', 'trauma-informed parenting intervention in the Illinois Birth through Three Title IV-E waiver demonstration or foster care services as usual']",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0580719', 'cui_str': 'Child in foster care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0682416', 'cui_str': 'Ruanda language'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],414.0,0.0411425,"For the reunification outcome, the MOB produced the following three treatment moderators, which identified subgroups of participants who responded differently to the intervention: (a) caregivers' relationship with the child (kin vs. non-kin/permanent caregivers), (b) caregiver-child attachment, and (c) case history of physical abuse.","[{'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Chung', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, USA. Electronic address: gcsk1982@live.unc.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ansong', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, USA.'}, {'ForeName': 'Kanisha C', 'Initials': 'KC', 'LastName': 'Brevard', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, USA.'}, {'ForeName': 'Ding-Geng', 'Initials': 'DG', 'LastName': 'Chen', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, USA.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.105065']
1101,33858855,"Effects of the SGLT2 Inhibitor Dapagliflozin on Energy Metabolism in Patients With Type 2 Diabetes: A Randomized, Double-Blind Crossover Trial.","OBJECTIVE


SGTL2 inhibitors increase urinary glucose excretion and have beneficial effects on cardiovascular and renal outcomes. The underlying mechanism may involve caloric restriction-like metabolic effects due to urinary glucose loss. We investigated the effects of dapagliflozin on 24-h energy metabolism and insulin sensitivity in patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS


There were 26 patients with type 2 diabetes randomized to a 5-week double-blind, crossover study with a 6- to 8-week washout. Indirect calorimetry was used to measure 24-h energy metabolism and the respiratory exchange ratio (RER), both by whole-room calorimetry and by ventilated hood during a two-step euglycemic-hyperinsulinemic clamp. Results are presented as the differences in least squares mean (95% CI) between treatments.
RESULTS


Evaluable patients ( n  = 24) had a mean (SD) age of 64.2 (4.6) years, BMI of 28.1 (2.4) kg/m 2 , and HbA 1c  of 6.9% (0.7) (51.7 [6.8] mmol/mol). Rate of glucose disappearance was unaffected by dapagliflozin, whereas fasting endogenous glucose production (EGP) increased by dapagliflozin (+2.27 [1.39, 3.14] μmol/kg/min,  P  < 0.0001). Insulin-induced suppression of EGP (-1.71 [-2.75, -0.63] μmol/kg/min,  P  = 0.0036) and plasma free fatty acids (-21.93% [-39.31, -4.54],  P  = 0.016) was greater with dapagliflozin. Twenty-four-hour energy expenditure (-0.11 [-0.24, 0.03] MJ/day) remained unaffected by dapagliflozin, but dapagliflozin reduced the RER during daytime and nighttime, resulting in an increased day-to-nighttime difference in the RER (-0.010 [-0.017, -0.002],  P  = 0.016). Dapagliflozin treatment resulted in a negative 24-h energy and fat balance (-20.51 [-27.90, -13.12] g/day).
CONCLUSIONS


Dapagliflozin treatment for 5 weeks resulted in major adjustments of metabolism mimicking caloric restriction, increased fat oxidation, improved hepatic and adipose insulin sensitivity, and improved 24-h energy metabolism.",2021,"Insulin-induced suppression of EGP (-1.71 [-2.75, -0.63] μmol/kg/min,  P  = 0.0036) and plasma free fatty acids (-21.93% [-39.31, -4.54],  P  = 0.016) was greater with dapagliflozin.","['26 patients with type 2 diabetes', 'Evaluable patients ( n  = 24) had a mean (SD) age of 64.2 (4.6) years, BMI of 28.1 (2.4) kg/m 2 , and HbA 1c  of 6.9% (0.7) (51.7 [6.8] mmol/mol', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes']","['dapagliflozin', 'SGLT2 Inhibitor Dapagliflozin', 'Dapagliflozin']","['RER during daytime and nighttime, resulting in an increased day-to-nighttime difference in the RER', '24-h energy metabolism and insulin sensitivity', 'negative 24-h energy and fat balance', 'Rate of glucose disappearance', 'Insulin-induced suppression of EGP', '24-h energy metabolism and the respiratory exchange ratio (RER', 'metabolism mimicking caloric restriction, increased fat oxidation, improved hepatic and adipose insulin sensitivity, and improved 24-h energy metabolism', 'urinary glucose excretion', 'fasting endogenous glucose production (EGP', 'Energy Metabolism', 'plasma free fatty acids']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0903677', 'cui_str': 'TACSTD1 protein, human'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}]",26.0,0.175956,"Insulin-induced suppression of EGP (-1.71 [-2.75, -0.63] μmol/kg/min,  P  = 0.0036) and plasma free fatty acids (-21.93% [-39.31, -4.54],  P  = 0.016) was greater with dapagliflozin.","[{'ForeName': 'Yvo J M', 'Initials': 'YJM', 'LastName': 'Op den Kamp', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'de Ligt', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Dautzenberg', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Esterline', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Matthijs K C', 'Initials': 'MKC', 'LastName': 'Hesselink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Hoeks', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'BioPharmaceuticals R&D, Late-Stage Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands p.schrauwen@maastrichtuniversity.nl.'}]",Diabetes care,['10.2337/dc20-2887']
1102,33857028,Mononitrate Isosorbide as an Adjunctive Therapy in Schizophrenia: A Randomized Controlled Crossover Trial.,"BACKGROUND


Schizophrenia is a complex disabling mental disorder, and many patients present poor response to available treatments. Accumulating evidence about the role of the glutamate/nitric oxide pathway in mediating the positive and negative symptoms of schizophrenia suggests potential benefits of drugs that modulate this system. The aim of this study was to test the efficacy of isosorbide mononitrate (ISMN) as an adjunctive therapy for symptomatic outpatients with schizophrenia.
METHODS


This was a 2-month randomized, double-blind, placebo-controlled trial with 24 schizophrenia patients. Participants were treated with ISMN 50 mg for 1 month and placebo for another month in a crossover design. The Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale, Global Assessment of Functioning, and MATRICS Cognitive Consensual Battery were used for symptom assessment and arterial spin labeling was used to assess brain activation patterns.
RESULTS


We found significant differences in the total, general, and positive subscales of the PANSS, Global Assessment of Functioning scores, and Clinical Global Impression scores during treatment with ISMN relative to placebo. No treatment effects were found comparing scores in the MATRICS Cognitive Consensual Battery and the negative subscale of the PANSS between the active and placebo conditions. A post hoc analysis of neuroimaging data showed reduced activity in the thalamus in subgroup of patients with severe psychopathology.
CONCLUSIONS


Schizophrenia patients with persistent symptoms showed significant improvement after 4 weeks of treatment with ISMN 50 mg/d compared with placebo. Isosorbide mononitrate added beneficial effects to antipsychotic treatment in terms of positive symptoms and functioning.",2021,No treatment effects were found comparing scores in the MATRICS Cognitive Consensual Battery and the negative subscale of the PANSS between the active and placebo conditions.,"['24 schizophrenia patients', 'symptomatic outpatients with schizophrenia', 'Schizophrenia']","['Mononitrate Isosorbide', 'ISMN', 'placebo', 'Isosorbide', 'isosorbide mononitrate (ISMN']","['Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale, Global Assessment of Functioning, and MATRICS Cognitive Consensual Battery', 'brain activation patterns', 'Cognitive Consensual Battery and the negative subscale of the PANSS', 'positive symptoms and functioning', 'total, general, and positive subscales of the PANSS, Global Assessment of Functioning scores, and Clinical Global Impression scores']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0064079', 'cui_str': 'isosorbide mononitrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022251', 'cui_str': 'Isosorbide'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",24.0,0.255588,No treatment effects were found comparing scores in the MATRICS Cognitive Consensual Battery and the negative subscale of the PANSS between the active and placebo conditions.,"[{'ForeName': 'Tiago M', 'Initials': 'TM', 'LastName': 'Guimarães', 'Affiliation': ''}, {'ForeName': 'Mara R C', 'Initials': 'MRC', 'LastName': 'Guimarães', 'Affiliation': ''}, {'ForeName': 'Ícaro A F', 'Initials': 'ÍAF', 'LastName': 'Oliveira', 'Affiliation': ''}, {'ForeName': 'Renata F', 'Initials': 'RF', 'LastName': 'Leoni', 'Affiliation': 'Physics Department, FFCLRP, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Santos', 'Affiliation': 'Radiology Division, Department of Internal Medicine, Ribeirao Preto Medical School, University of São Paulo USP), São Paulo, Brazil.'}, {'ForeName': 'Serdar M', 'Initials': 'SM', 'LastName': 'Dursun', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jose A S', 'Initials': 'JAS', 'LastName': 'Crippa', 'Affiliation': ''}, {'ForeName': 'Rodrigo A', 'Initials': 'RA', 'LastName': 'Bressan', 'Affiliation': 'Department of Psychiatry, Interdisciplinary Lab of Clinical Neurosciences (LiNC), and Schizophrenia Program (PROESQ), Federal São Paulo University (Unifesp), São Paulo, Brazil.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Machado-de-Sousa', 'Affiliation': ''}, {'ForeName': 'Acioly L T', 'Initials': 'ALT', 'LastName': 'Lacerda', 'Affiliation': 'Department of Psychiatry, Interdisciplinary Lab of Clinical Neurosciences (LiNC), and Schizophrenia Program (PROESQ), Federal São Paulo University (Unifesp), São Paulo, Brazil.'}, {'ForeName': 'Jaime E Cecílio', 'Initials': 'JEC', 'LastName': 'Hallak', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001388']
1103,33864634,Clinical Features of Essential Voice Tremor and Associations with Tremor Severity and Response to Octanoic Acid Treatment.,"OBJECTIVES/HYPOTHESIS


The purpose of this study was to characterize the clinical features, tremor variability, and factors related to octanoic acid (OA) treatment response in essential voice tremor (EVT).
STUDY DESIGN


Prospective, double blind, placebo-controlled, crossover study with secondary analysis.
METHODS


Clinical tremor features in 16 individuals with EVT were comprehensively assessed, and correlations with acoustic tremor severity were determined. Intrasubject and intersubject variability measures were analyzed from 18 repeated measures for each acoustic tremor variable. Clinical correlates of treatment response were evaluated, and cumulative effects over a 2-week period of OA drug dosing were assessed.
RESULTS


Participants with EVT were 90% female with a mean age of 70.31 (±8.68) years at the time of testing. Neurologist-rated body tremor beyond the vocal tract region was present in 69% of participants, and multiple vocal tract regions contributed to the voice tremor. The mean frequency of amplitude tremor was 4.67 Hz (±0.88). Respiratory tremor was evident in 50% of participants. Participants experienced moderate voice-related disability as assessed on the Voice Handicap Index-10 (19.38, ±8.50), and increased speaking effort. Acoustic tremor severity was significantly associated with severity of tremor affecting vocal tract structures. Overall intrasubject consistency was strong (single measures intraclass correlation coefficient = 0.701, P < .01), with high intersubject variability. Acoustic tremor severity was significantly, positively associated with treatment response, and results suggested a cumulative OA benefit for magnitude of amplitude tremor.
CONCLUSIONS


This study identified common clinical correlates of EVT and demonstrated positive associations between acoustic tremor severity, severity of affected vocal tract structures, and response to treatment.
LEVEL OF EVIDENCE


2 Laryngoscope, 131:E2792-E2801, 2021.",2021,"Acoustic tremor severity was significantly, positively associated with treatment response, and results suggested a cumulative OA benefit for magnitude of amplitude tremor.
","['Participants with EVT were 90% female with a mean age of 70.31 (±8.68) years at the time of testing', '16 individuals with EVT']",['placebo'],"['moderate voice-related disability', 'Respiratory tremor', 'Acoustic tremor severity', 'mean frequency of amplitude tremor', 'Voice Handicap Index-10']","[{'cui': 'C0234809', 'cui_str': 'Organic voice tremor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}]",16.0,0.0393706,"Acoustic tremor severity was significantly, positively associated with treatment response, and results suggested a cumulative OA benefit for magnitude of amplitude tremor.
","[{'ForeName': 'Soren Y', 'Initials': 'SY', 'LastName': 'Lowell', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Kelley', 'Affiliation': 'Department of Otolaryngology and Communication Sciences, SUNY Upstate Medical University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Dischinat', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Monahan', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Carly J', 'Initials': 'CJ', 'LastName': 'Hosbach-Cannon', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Colton', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Mihaila', 'Affiliation': 'Department of Neurology, SUNY Upstate Medical University, Syracuse, New York, U.S.A.'}]",The Laryngoscope,['10.1002/lary.29558']
1104,33861881,Health warning labels and alcohol selection: a randomised controlled experiment in a naturalistic shopping laboratory.,"BACKGROUND AND AIMS


Health warning labels (HWLs) on tobacco products reduce smoking. There is an absence of evidence concerning the impact of alcohol HWLs on selection or purchasing in naturalistic settings. Using a commercial-standard naturalistic shopping laboratory, this study aimed to estimate the impact on selection of alcoholic drinks of HWLs describing adverse health consequences of excessive alcohol consumption.
DESIGN


A between-subjects randomised experiment with three groups was conducted: group 1: image-and-text HWL; group 2: text-only HWL; group 3: no HWL.
SETTING


A commercial-standard naturalistic shopping laboratory in the United Kingdom.
PARTICIPANTS


Adults (n = 399, 55% female) over the age of 18 years, who purchased beer or wine weekly to drink at home.
INTERVENTIONS


Participants were randomised to one of three groups varying in the HWL displayed on the packaging of the alcoholic drinks: (i) image-and-text HWL (n = 135); (ii) text-only HWL (n = 129); (iii) no HWL (n = 135). Participants completed a shopping task, selecting items from a range of alcoholic and non-alcoholic drinks, and snacks.
MEASUREMENT


The primary outcome was the proportion of alcoholic drinks selected. Secondary outcomes included HWL ratings on negative emotional arousal and label acceptability.
FINDINGS


There was no clear evidence of a difference in the HWL groups for the percentage of drinks selected that were alcoholic compared to no HWL (44%): image-and-text HWL: 46% (odds ratio [OR] = 1.08, 95% confidence interval [CI] = 0.82, 1.42); text-only HWL: 41% (OR = 0.87, 95% CI = 0.67, 1.14). Concordant with there being no difference between groups, there was extreme evidence in favour of the null hypothesis (Bayes factor [BF] < 0.01). Negative emotional arousal was higher (P < 0.001) and acceptability lower (P < 0.001) in the image-and-text HWL group, compared to the text-only HWL group.
CONCLUSIONS


In a naturalistic shopping laboratory, there was no evidence that health warning labels describing the adverse health consequences of excessive alcohol consumption changed selection behaviour.",2021,"Negative emotional arousal was higher (p< 0.001) and acceptability lower (p< 0.001) in the image-and-text HWL group, compared to the text-only HWL group.
","['A commercial-standard naturalistic shopping laboratory in the United Kingdom', 'Adults (n=399, 55% female) over the age of 18, who purchased beer or wine weekly to drink at home']","['alcoholic drinks: i. image-and-text HWL', 'image-and-text HWL; Group 2: text-only HWL; Group 3: no HWL', 'Health warning labels and alcohol selection']","['HWL ratings on negative emotional arousal and label acceptability', 'Negative emotional arousal', 'proportion of alcoholic drinks selected']","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0556305', 'cui_str': 'Drinks at home'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]",,0.147784,"Negative emotional arousal was higher (p< 0.001) and acceptability lower (p< 0.001) in the image-and-text HWL group, compared to the text-only HWL group.
","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Behaviour and Health Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Hobson', 'Affiliation': 'Behaviour and Health Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pilling', 'Affiliation': 'Behaviour and Health Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.15519']
1105,33872652,Astegolimab (anti-ST2) efficacy and safety in adults with severe asthma: A randomized clinical trial.,"BACKGROUND


The IL-33/ST2 pathway is linked with asthma susceptibility. Inhaled allergens, pollutants, and respiratory viruses, which trigger asthma exacerbations, induce release of IL-33, an epithelial-derived ""alarmin."" Astegolimab, a human IgG 2  mAb, selectively inhibits the IL-33 receptor, ST2. Approved biologic therapies for severe asthma mainly benefit patients with elevated blood eosinophils (type 2-high), but limited options are available for patients with low blood eosinophils (type 2-low). Inhibiting IL-33 signaling may target pathogenic pathways in a wider spectrum of asthmatics.
OBJECTIVES


This study evaluated astegolimab efficacy and safety in patients with severe asthma.
METHODS


This double-blind, placebo-controlled, dose-ranging study (ZENYATTA [A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma]) randomized 502 adults with severe asthma to subcutaneous placebo or 70-mg, 210-mg, or 490-mg doses of astegolimab every 4 weeks. The primary endpoint was the annualized asthma exacerbation rate (AER) at week 54. Enrollment caps ensured ∼30 patients who were eosinophil-high (≥300 cells/μL) and ∼95 patients who were eosinophil-low (<300 cells/μL) per arm.
RESULTS


Overall, adjusted AER reductions relative to placebo were 43% (P = .005), 22% (P = .18), and 37% (P = .01) for 490-mg, 210-mg, and 70-mg doses of astegolimab, respectively. Adjusted AER reductions for patients who were eosinophil-low were comparable to reductions in the overall population: 54% (P = .002), 14% (P = .48), and 35% (P = .05) for 490-mg, 210-mg, and 70-mg doses of astegolimab. Adverse events were similar in astegolimab- and placebo-treated groups.
CONCLUSIONS


Astegolimab reduced AER in a broad population of patients, including those who were eosinophil-low, with inadequately controlled, severe asthma. Astegolimab was safe and well tolerated.",2021,"Overall, adjusted AER reductions relative to placebo were 43% (p=0.005), 22% (p=0.18), and 37% (p=0.01) for 490-mg, 210-mg, and 70-mg astegolimab, respectively.","['adults with severe asthma', '502 adults with severe asthma to subcutaneous placebo or 70-mg, 210-mg, or 490-mg astegolimab every 4 weeks', 'patients with low blood eosinophils (Type 2-low', 'patients with severe asthma', 'severe asthma mainly benefit patients with elevated blood eosinophils (Type 2-high']","['placebo', 'EudraCT', 'Astegolimab (anti-ST2']","['annualized asthma exacerbation rate (AER', 'Adverse events', '∼30 eosinophil-high (≥300 cells/μL) and ∼95 eosinophil-low', 'release of IL-33, an epithelial-derived ""alarmin', 'Adjusted AER reductions', 'safe and well tolerated']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0450499', 'cui_str': 'ST2'}]","[{'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1667752', 'cui_str': 'IL33 protein, human'}, {'cui': 'C3891560', 'cui_str': 'Alarmin'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",502.0,0.285102,"Overall, adjusted AER reductions relative to placebo were 43% (p=0.005), 22% (p=0.18), and 37% (p=0.01) for 490-mg, 210-mg, and 70-mg astegolimab, respectively.","[{'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Kelsen', 'Affiliation': 'Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pa.'}, {'ForeName': 'Ioana O', 'Initials': 'IO', 'LastName': 'Agache', 'Affiliation': 'Allergy and Clinical Immunology, Faculty of Medicine, Transylvania University, Brasov, Romania.'}, {'ForeName': 'Weily', 'Initials': 'W', 'LastName': 'Soong', 'Affiliation': 'Alabama Allergy and Asthma Center and Clinical Research Center of Alabama, Birmingham, Ala.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Divisions of Pulmonary and Critical Care Medicine and Allergy and Immunology, Brigham and Women's Hospital, and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Geoffrey L', 'Initials': 'GL', 'LastName': 'Chupp', 'Affiliation': 'Division of Pulmonary and Critical Care and Sleep Medicine, Yale School of Medicine, New Haven, Conn.'}, {'ForeName': 'Dorothy S', 'Initials': 'DS', 'LastName': 'Cheung', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Theess', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Staton', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Choy', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Fong', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Dash', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dolton', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Pappu', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Brightling', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicestershire, United Kingdom. Electronic address: ceb17@leicester.ac.uk.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.03.044']
1106,33835597,Randomized controlled trials of self-monitoring interventions with or without incentives for diet and exercise among individuals with overweight or obesity: Psychological and behavioural effects.,"OBJECTIVES


To test the effects of three behavioural interventions (daily monetary incentives + self-monitoring, delayed lump sum monetary incentives + self-monitoring, and self-monitoring only) on psychological constructs and fruit and vegetable consumption or physical activity behaviour change among a sample of adults with overweight or obesity.
DESIGN


A pair of 3-arm longitudinal randomized controlled trials compared daily monetary incentives + self-monitoring, delayed lump sum monetary incentives + self-monitoring, and self-monitoring only interventions for either fruit and vegetable consumption or physical activity.
METHODS


Individuals reporting elevated weight status and insufficient engagement in one of the target behaviours were randomly assigned to one of three 3-week interventions. All three interventions involved daily self-monitoring of the behaviour, and two provided monetary incentives contingent upon reported behaviour. Participants completed measures of psychological constructs and reported behaviour at baseline, the end of the intervention, and two and four weeks post-intervention.
RESULTS


Participants across all three intervention conditions demonstrated increased engagement in the target behaviour from pre- to post-intervention and reported behaviour remained above baseline levels at both follow-up time points. Increases in reported behaviour during the intervention were associated with increases in self-efficacy, and this enhanced self-efficacy prospectively predicted sustained reported behaviour at follow-up. However, contrary to hypotheses, the incentive interventions including self-monitoring were not more efficacious than self-monitoring alone, and increased reported behaviour was not associated with enhancements in attitudes.
CONCLUSIONS


Self-monitoring interventions can aid behaviour change efforts, and behavioural practice during these interventions can increase self-efficacy. However, among adults with overweight or obesity who are seeking behaviour change interventions, incentive-based self-monitoring approaches may not be superior to self-monitoring alone in driving behaviour change and maintenance.",2021,"However, contrary to hypotheses, the incentive interventions including self-monitoring were not more efficacious than self-monitoring alone, and increased reported behaviour was not associated with enhancements in attitudes.
","['Individuals reporting elevated weight status and insufficient engagement in one of the target behaviours', 'individuals with overweight or obesity', 'adults with overweight or obesity']","['self-monitoring interventions with or without incentives for diet and exercise', 'behavioural interventions (daily monetary incentives\xa0+\xa0self-monitoring, delayed lump sum monetary incentives\xa0+\xa0self-monitoring, and self-monitoring only) on psychological constructs and fruit and vegetable consumption or physical activity behaviour change', 'daily monetary incentives\xa0+\xa0self-monitoring, delayed lump sum monetary incentives\xa0+\xa0self-monitoring, and self-monitoring only interventions for either fruit and vegetable consumption or physical activity']","['psychological constructs and reported behaviour', 'self-efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0364455,"However, contrary to hypotheses, the incentive interventions including self-monitoring were not more efficacious than self-monitoring alone, and increased reported behaviour was not associated with enhancements in attitudes.
","[{'ForeName': 'Casey K', 'Initials': 'CK', 'LastName': 'Gardiner', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Colorado, USA.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Colorado, USA.'}]",British journal of health psychology,['10.1111/bjhp.12523']
1107,33838898,Early enteral feeding versus traditional feeding in neonatal congenital gastrointestinal malformation undergoing intestinal anastomosis: A randomized multicenter controlled trial of an enhanced recovery after surgery (ERAS) component.,"PURPOSE


the aim of this clinical trial was to evaluate the safety and efficacy of early enteral feeding (EEN) following intestinal anastomosis in neonates with congenital gastrointestinal malformation.
METHODS


a multicenter, prospective, randomized controlled trial (registered under chictr.org.cn Identifier no.ChiCTR-INR-17014179) was conducted between 2018 and 2019. Four centers in China analyzed 156 newborns of congenital gastrointestinal malformation undergoing intestinal anastomosis to EEN group (n = 78) or control (C) group (n = 78). The primary outcomes of this study were length of postoperative stay (LOPS) and time to full feeds. Secondary outcomes included morbidity of complications, parenteral nutrition (PN) duration, feeding intolerance, 30 day mortality rate and 30 day readmission rate.
RESULTS


the mean time to full feeds and LOPS in the EEN group were 15.0 (9.8-22.8) days and 17.6 (12.0-29.8) days, while that were 18.0 (12.0-24.0) days and 20.0 (15.0-30.3) days in C groups respectively. There was no significant difference between two groups(P >0.05). No significant intergroup difference was found with respect to postoperative morbidity, PN duration or feeding intolerance(P >0.05).
CONCLUSIONS


early enteral feeding following intestinal anastomosis in neonates with congenital gastrointestinal malformation is safe. Post-operative outcomes demonstrated a trend toward improvement.
LEVEL OF EVIDENCE


Level Ⅰ.",2021,"No significant intergroup difference was found with respect to postoperative morbidity, PN duration or feeding intolerance(P >0.05).
","['neonates with congenital gastrointestinal malformation', 'Four centers in China analyzed 156 newborns of congenital gastrointestinal malformation undergoing intestinal anastomosis to EEN group (n\xa0=\xa078) or control (C) group (n\xa0=\xa078', 'neonatal congenital gastrointestinal malformation undergoing intestinal anastomosis']","['early enteral feeding (EEN', 'Early enteral feeding versus traditional feeding']","['safety and efficacy', 'length of postoperative stay (LOPS) and time to full feeds', 'postoperative morbidity, PN duration or feeding intolerance(P\xa0>0.05', 'morbidity of complications, parenteral nutrition (PN) duration, feeding intolerance, 30 day mortality rate and 30 day readmission rate', 'mean time to full feeds and LOPS']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0012241', 'cui_str': 'Congenital anomaly of gastrointestinal tract'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.121417,"No significant intergroup difference was found with respect to postoperative morbidity, PN duration or feeding intolerance(P >0.05).
","[{'ForeName': 'Yanfen', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Xiao', 'Affiliation': ""Department of General Surgery, Shenzhen Children's Hospital, Shenzhen, China.""}, {'ForeName': 'Shangjie', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': ""Department of Neonatal Surgery, Guangdong Women and Children's Hospital, Guangdong, China.""}, {'ForeName': 'Liucheng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Zhujiang Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""Guangzhou Women and Children's Medical Center, Institute of Pediatrics, Guangzhou, China.""}, {'ForeName': 'Qiuming', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Haozhong', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of General Surgery, Shenzhen Children's Hospital, Shenzhen, China.""}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Neonatal Surgery, Guangdong Women and Children's Hospital, Guangdong, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Jiakang', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China. Electronic address: jiakangyu@hotmail.com.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2021.02.067']
1108,33845988,"Hyaluronic acid-enriched transfer medium for frozen embryo transfer: a randomized, double-blind, controlled trial.","OBJECTIVE


To compare the effects of hyaluronic acid (HA)-enriched transfer medium versus standard medium on live birth rate after frozen embryo transfer (FET).
DESIGN


Randomized, double-blind, controlled trial.
SETTING


Two tertiary fertility centers.
PATIENT(S)


Infertile women aged <43 years at the time of in vitro fertilization undergoing FET.
INTERVENTION(S)


The women were randomly assigned to 2 groups in a 1:1 ratio. The HA group used EmbryoGlue (Vitrolife, Gothenburg, Sweden) with an HA concentration of 0.5 mg/mL, while the control group used supplemented G-2 (Vitrolife) medium with an HA concentration of 0.125 mg/mL.
MAIN OUTCOME MEASURE(S)


Live birth rate.
RESULT(S)


Five hundred fifty women were recruited from April 2016 to April 2018 and included in the intention-to-treat analysis. Eight women in the HA group and 5 women in the control group did not undergo FET because the embryos did not survive on thawing. One woman in the HA group cancelled FET because of fever. One woman in the HA group withdrew and received conventional medium. The 2 groups were similar in demographic characteristics. The live birth rates in the HA group and the control group were comparable (25.5% vs. 25.8%; relative risk 0.99; 95% confidence interval 0.74-1.31). The other clinical outcomes were also similar between the 2 groups. Logistic regression showed that the type of transfer medium was not associated with live birth.
CONCLUSION(S)


The use of HA-enriched transfer medium does not improve the live birth rate of FET compared with standard medium.
TRIAL REGISTRATION NUMBER


NCT02725827 (ClinicalTrials.gov).",2021,Eight women in the HA group and 5 women in the control group did not undergo FET because the embryos did not survive on thawing.,"['Five hundred fifty women were recruited from April 2016 to April 2018 and included in the intention-to-treat analysis', 'Infertile women aged <43 years at the time of in\xa0vitro fertilization undergoing FET', 'frozen embryo transfer', 'Two tertiary fertility centers']","['Hyaluronic acid-enriched transfer medium', 'conventional medium', 'hyaluronic acid (HA)-enriched transfer medium versus standard medium']","['live birth rate', 'live birth rates', 'live birth rate of FET', 'FET because of fever']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",550.0,0.472701,Eight women in the HA group and 5 women in the control group did not undergo FET because the embryos did not survive on thawing.,"[{'ForeName': 'Sofie Shuk Fei', 'Initials': 'SSF', 'LastName': 'Yung', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China. Electronic address: ssfyung@hku.hk.""}, {'ForeName': 'Shui Fan', 'Initials': 'SF', 'LastName': 'Lai', 'Affiliation': ""Department of Obstetrics and Gynaecology, Kwong Wah Hospital, Yaumatei, Kowloon, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Mei Ting', 'Initials': 'MT', 'LastName': 'Lam', 'Affiliation': ""Department of Obstetrics and Gynaecology, Kwong Wah Hospital, Yaumatei, Kowloon, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Ellen Man Wa', 'Initials': 'EMW', 'LastName': 'Lui', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Jennifer Ka Yee', 'Initials': 'JKY', 'LastName': 'Ko', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Hang Wun Raymond', 'Initials': 'HWR', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Jacki Yuk Ying', 'Initials': 'JYY', 'LastName': 'Wong', 'Affiliation': ""Department of Obstetrics and Gynaecology, Kwong Wah Hospital, Yaumatei, Kowloon, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Estella Yee Lan', 'Initials': 'EYL', 'LastName': 'Lau', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'William Shu Biu', 'Initials': 'WSB', 'LastName': 'Yeung', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Ernest Hung Yu', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}]",Fertility and sterility,['10.1016/j.fertnstert.2021.02.015']
1109,33872070,Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50.,"PURPOSE


We report the first 5-year follow-up of any first-line phase III immunotherapy trial for non-small-cell lung cancer (NSCLC). KEYNOTE-024 (ClinicalTrials.gov identifier: NCT02142738) is an open-label, randomized controlled trial of pembrolizumab compared with platinum-based chemotherapy in patients with previously untreated NSCLC with a programmed death ligand-1 (PD-L1) tumor proportion score of at least 50% and no sensitizing  EGFR  or  ALK  alterations. Previous analyses showed pembrolizumab significantly improved progression-free survival and overall survival (OS).
METHODS


Eligible patients were randomly assigned (1:1) to pembrolizumab (200 mg once every 3 weeks for up to 35 cycles) or platinum-based chemotherapy. Patients in the chemotherapy group with progressive disease could cross over to pembrolizumab. The primary end point was progression-free survival; OS was a secondary end point.
RESULTS


Three hundred five patients were randomly assigned: 154 to pembrolizumab and 151 to chemotherapy. Median (range) time from randomization to data cutoff (June 1, 2020) was 59.9 (55.1-68.4) months. Among patients initially assigned to chemotherapy, 99 received subsequent anti-PD-1 or PD-L1 therapy, representing a 66.0% effective crossover rate. Median OS was 26.3 months (95% CI, 18.3 to 40.4) for pembrolizumab and 13.4 months (9.4-18.3) for chemotherapy (hazard ratio, 0.62; 95% CI, 0.48 to 0.81). Kaplan-Meier estimates of the 5-year OS rate were 31.9% for the pembrolizumab group and 16.3% for the chemotherapy group. Thirty-nine patients received 35 cycles (ie, approximately 2 years) of pembrolizumab, 82.1% of whom were still alive at data cutoff (approximately 5 years). Toxicity did not increase with longer treatment exposure.
CONCLUSION


Pembrolizumab provides a durable, clinically meaningful long-term OS benefit versus chemotherapy as first-line therapy for metastatic NSCLC with PD-L1 tumor proportion score of at least 50%.",2021,"Median OS was 26.3 months (95% CI, 18.3-40.4) for pembrolizumab and 13.4 months (9.4-18.3) for chemotherapy (hazard ratio, 0.62; 95% CI, 0.48-0.81).","['Eligible patients', 'non-small-cell lung cancer (NSCLC', 'Three hundred five patients were randomly assigned: 154 to', 'patients with previously untreated NSCLC with a programmed death ligand-1 (PD-L1) tumor proportion score of at least 50% and no sensitizing  EGFR  or  ALK  alterations', 'Metastatic Non-Small-Cell Lung Cancer']","['Pembrolizumab', 'subsequent anti-PD-1 or PD-L1 therapy', 'Pembrolizumab Versus Chemotherapy', 'chemotherapy', 'pembrolizumab', 'platinum-based chemotherapy']","['progression-free survival and overall survival (OS', 'Median OS', '5-year OS rate', 'progression-free survival; OS', 'Toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",305.0,0.359089,"Median OS was 26.3 months (95% CI, 18.3-40.4) for pembrolizumab and 13.4 months (9.4-18.3) for chemotherapy (hazard ratio, 0.62; 95% CI, 0.48-0.81).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodríguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Robinson', 'Affiliation': 'Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, ON, Canada.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital and the University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csőszi', 'Affiliation': 'Jász-Nagykun-Szolnok County Hospital, Szolnok, Hungary.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fülöp', 'Affiliation': 'Országos Korányi Pulmonológiai Intézet, Budapest, Hungary.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Gottfried', 'Affiliation': 'Meir Medical Center, Kfar-Saba, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Peled', 'Affiliation': 'Soroka Cancer Center, Ben Gurion University, Beer Sheva, Israel.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tafreshi', 'Affiliation': 'Wollongong Private Hospital and University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Cuffe', 'Affiliation': ""St James's Hospital and Cancer Trials Ireland (formerly ICORG-All Ireland Cooperative Oncology Research Group), Dublin, Ireland.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'The Royal Marsden Hospital, Sutton, Surrey, UK.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'MedStar Franklin Square Hospital, Baltimore, MD.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Ticiana A', 'Initials': 'TA', 'LastName': 'Leal', 'Affiliation': 'Carbone Cancer Center, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Riess', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, CA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Jensen', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Pietanza', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Brahmer', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.00174']
1110,33883196,Dasiglucagon: A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia Results of Phase 3 Randomized Double-Blind Clinical Trial.,,2021,,[],['Dasiglucagon'],[],[],[],[],,0.632392,,"[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Medical University of Graz, Graz, Austria thomas.pieber@meduigraz.at.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes and Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hövelmann', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Willard', 'Affiliation': 'ProSciento, San Diego, CA.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Knudsen', 'Affiliation': 'Zealand Pharma, Søborg, Denmark.'}, {'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Bandak', 'Affiliation': 'Zealand Pharma, Søborg, Denmark.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tehranchi', 'Affiliation': 'Zealand Pharma, Søborg, Denmark.'}]",Diabetes care,['10.2337/DC20-2995']
1111,33883195,"Feasibility of Simplification From a Basal-Bolus Insulin Regimen to a Fixed-Ratio Formulation of Basal Insulin Plus a GLP-1RA or to Basal Insulin Plus an SGLT2 Inhibitor: BEYOND, a Randomized, Pragmatic Trial.","OBJECTIVE


BEYOND trial evaluated the feasibility of either basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1RA) or basal insulin plus sodium-glucose cotransporter 2 inhibitor (SGLT2i) to replace a full basal-bolus insulin (BBI) regimen in participants with type 2 diabetes and inadequate glycemic control.
RESEARCH DESIGN AND METHODS


Participants were randomized (1:1:1) to:  1 ) intensification of the BBI regimen ( n  = 101),  2 ) fixed ratio of basal insulin plus GLP-1RA (fixed-combo group;  n  = 102), and  3 ) combination of basal insulin plus SGLT2i (gliflo-combo group;  n  = 102). The primary efficacy outcome was change from baseline in HbA 1c  at 6 months.
RESULTS


Baseline characteristics were similar among the three groups (mean HbA 1c  was 8.6% [70 mmol/mol]). At 6 months, patients experienced similar reduction in HbA 1c  level (-0.6 ± 0.8, -0.6 ± 0.8, and -0.7 ± 0.9%, mean ± SD, respectively; noninferiority  P  < 0.001 vs. BBI), and the proportion of patients with HbA 1c  ≤7.5% was also similar (34%, 28%, and 27%, respectively;  P  = 0.489). Total insulin dose increased in the BBI group (62 units/day) and decreased both in the fixed-combo and gliflo-combo groups (27 units/day and 21 units/day, respectively;  P  < 0.01). The proportion of patients with hypoglycemia was 17.8%, 7.8%, and 5.9%, respectively ( P  = 0.015). There were 12 dropouts in the fixed-combo group, 9 in the gliflo-combo group, and none in the BBI group.
CONCLUSIONS


BEYOND provides evidence that it is possible and safe to switch from a BBI regimen to either a once-daily fixed-combo injection or once-daily gliflozin added to basal insulin, with similar glucose control, fewer insulin doses, fewer injections daily, and less hypoglycemia.",2021,"Total insulin dose increased in the BBI group (62 units/day) and decreased both in the fixed-combo and gliflo-combo groups (27 units/day and 21 units/day, respectively;  P  < 0.01).","['Participants', 'participants with type 2 diabetes and inadequate glycemic control', 'group;  n  = 102']","['Basal Insulin Plus a GLP-1RA or to Basal Insulin Plus an SGLT2 Inhibitor', 'BBI regimen ( n  = 101),  2 ) fixed ratio of basal insulin plus GLP-1RA (fixed-combo group;  n  = 102), and  3 ', 'basal insulin plus SGLT2i (gliflo-combo', 'basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1RA) or basal insulin plus sodium-glucose cotransporter 2 inhibitor (SGLT2i']","['hypoglycemia', 'proportion of patients with hypoglycemia', 'Total insulin dose']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.142497,"Total insulin dose increased in the BBI group (62 units/day) and decreased both in the fixed-combo and gliflo-combo groups (27 units/day and 21 units/day, respectively;  P  < 0.01).","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Giugliano', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Advanced Medical and Surgical Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy dario.giugliano@unicampania.it.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Longo', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Advanced Medical and Surgical Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Caruso', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Advanced Medical and Surgical Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Di Fraia', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Advanced Medical and Surgical Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Scappaticcio', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Advanced Medical and Surgical Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Gicchino', 'Affiliation': 'Diabetes Unit, Department of Advanced Medical and Surgical Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Petrizzo', 'Affiliation': 'Diabetes Unit, Department of Advanced Medical and Surgical Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bellastella', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Advanced Medical and Surgical Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Maria Ida', 'Initials': 'MI', 'LastName': 'Maiorino', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Advanced Medical and Surgical Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Esposito', 'Affiliation': 'Diabetes Unit, Department of Advanced Medical and Surgical Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}]",Diabetes care,['10.2337/dc20-2623']
1112,33875726,Application of Three-dimensional Visualization Fused with Ultrasound for Percutaneous Renal Puncture.,"We present here the three-dimensional (3D) visualization fused with ultrasound and to evaluate its clinical application effect preliminarily. One hundred and eighteen patients with renal calculi in our hospital from September 2017 to December 2019 were prospectively randomized into two groups. The experimental group was treated with percutaneous renal puncture guided by the 3D visualization fused with ultrasound. The control group was treated with percutaneous renal puncture guided by B-ultrasonography (B-US). The puncture time in the experimental versus control group was 4.36 ± 1.28 min versus 10.72 ± 2.94 min (P = 0.000), operation time was 65.85 ± 10.63 min versus 81.34 ± 12.52 min (P = 0.000), and the loss of hemoglobin was 8.55 ± 3.76 g/L min versus 13.33 ± 5.81 g/L(P = 0.000), and the success rate of establishing the channel at one time was 98.41% versus 81.82% (P = 0.002), and the coincidence rate between the channel and the longitudinal axis of the target renal calyx was 88.89% versus 60.00% (P = 0.000). The 3D visualization fused with ultrasound could guide precise puncture to target calyces, reduce operation time, bleeding, and difficulty of puncture.",2021,"The puncture time in the experimental versus control group was 4.36 ± 1.28 min versus 10.72 ± 2.94 min (P = 0.000), operation time was 65.85 ± 10.63 min versus 81.34 ± 12.52 min (P = 0.000), and the loss of hemoglobin was 8.55 ± 3.76 g/L min versus 13.33 ± 5.81 g/L(P = 0.000), and the success rate of establishing the channel at one time was 98.41% versus 81.82% (P = 0.002), and the coincidence rate between the channel and the longitudinal axis of the target renal calyx was 88.89% versus 60.00% (P = 0.000).",['One hundred and eighteen patients with renal calculi in our hospital from September 2017 to December 2019'],"['percutaneous renal puncture guided by B-ultrasonography (B-US', 'percutaneous renal puncture guided by the 3D visualization fused with ultrasound']","['coincidence rate', 'success rate of establishing the channel at one time', 'puncture time', 'loss of hemoglobin', 'operation time', 'longitudinal axis of the target renal calyx', 'operation time, bleeding, and difficulty of puncture']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0022651', 'cui_str': 'Renal calyx'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",118.0,0.023744,"The puncture time in the experimental versus control group was 4.36 ± 1.28 min versus 10.72 ± 2.94 min (P = 0.000), operation time was 65.85 ± 10.63 min versus 81.34 ± 12.52 min (P = 0.000), and the loss of hemoglobin was 8.55 ± 3.76 g/L min versus 13.33 ± 5.81 g/L(P = 0.000), and the success rate of establishing the channel at one time was 98.41% versus 81.82% (P = 0.002), and the coincidence rate between the channel and the longitudinal axis of the target renal calyx was 88.89% versus 60.00% (P = 0.000).","[{'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of Urology, Taizhou People's Hospital, 366 Taihu Road, Taizhou, 225300, Jiangsu, China.""}, {'ForeName': 'Zhenchi', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Graduate School of Dalian Medical University, No.9 West Section, Lushun South Road, Dalian, 116044, China.'}, {'ForeName': 'MaoMao', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': ""Department of Urology, Taizhou People's Hospital, 366 Taihu Road, Taizhou, 225300, Jiangsu, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Bian', 'Affiliation': ""Department of Urology, Taizhou People's Hospital, 366 Taihu Road, Taizhou, 225300, Jiangsu, China.""}, {'ForeName': 'Tianli', 'Initials': 'T', 'LastName': 'Niu', 'Affiliation': ""Department of Urology, Taizhou People's Hospital, 366 Taihu Road, Taizhou, 225300, Jiangsu, China.""}, {'ForeName': 'Jiangping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Urology, Taizhou People's Hospital, 366 Taihu Road, Taizhou, 225300, Jiangsu, China. mingzhujp@126.com.""}]",Scientific reports,['10.1038/s41598-021-87972-8']
1113,33883635,Effect of four different forms of high intensity training on BDNF response to Wingate and Graded Exercise Test.,"This study examined the effects of a nine-week intervention of four different high-intensity training modalities [high-intensity functional training (HIFT), high-intensity interval training (HIIT), high-intensity power training (HIPT), and high-intensity endurance training (HIET)] on the resting concentration of brain-derived neurotropic factor (BDNF). In addition, we evaluated the BDNF responses to Graded Exercise Test (GXT) and Wingate Anaerobic Test (WAnT) in men. Thirty-five healthy individuals with body mass index 25.55 ± 2.35 kg/m 2  voluntarily participated in this study and were randomly assigned into four training groups. During nine-weeks they completed three exercise sessions per week for one-hour. BDNF was analyzed before and after a GXT and WAnT in two stages: (stage 0-before training and stage 9-after nine weeks of training). At stage 0, an increase in BDNF concentration was observed in HIFT (33%; p < 0.05), HIPT (36%; p < 0.05) and HIIT (38%; p < 0.05) after GXT. Even though HIET showed an increase in BDNF (10%) this was not statistically significant (p > 0.05). At stage 9, higher BDNF levels after GXT were seen only for the HIFT (30%; p < 0.05) and HIIT (18%; p < 0.05) groups. Reduction in BDNF levels were noted after the WAnT in stage 0 for HIFT (- 47%; p < 0.01), HIPT (- 49%; p < 0.001), HIET (- 18%; p < 0.05)], with no changes in the HIIT group (- 2%). At stage 9, BDNF was also reduced after WAnT, although these changes were lower compared to stage 0. The reduced level of BDNF was noted in the HIFT (- 28%; p < 0.05), and HIPT (- 19%;p < 0.05) groups. Additionally, all groups saw an improvement in VO 2max  (8%; p < 0.001), while BDNF was also correlated with lactate and minute ventilation and selected WAnT parameters. Our research has shown that resting values of BDNF after nine weeks of different forms of high-intensity training (HIT) have not changed or were reduced. Resting BDNF measured at 3th (before GXT at stage 9) and 6th day after long lasting HITs (before WAnT at stage 9) did not differed (before GXT), but in comparison to the resting value before WAnT at the baseline state, was lower in three groups. It appears that BDNF levels after one bout of exercise is depended on duration time, intensity and type of test/exercise.",2021,"At stage 0, an increase in BDNF concentration was observed in HIFT (33%; p < 0.05), HIPT (36%; p < 0.05) and HIIT (38%; p < 0.05) after GXT.","['men', 'Thirty-five healthy individuals with body mass index 25.55\u2009±\u20092.35\xa0kg/m 2  voluntarily participated in this study']","['high intensity training', 'high-intensity training modalities [high-intensity functional training (HIFT), high-intensity interval training (HIIT), high-intensity power training (HIPT), and high-intensity endurance training (HIET']","['VO 2max', 'BDNF', 'Resting BDNF', 'BDNF concentration', 'duration time, intensity and type of test/exercise', 'reduced level of BDNF', 'HIPT', 'BDNF responses to Graded Exercise Test (GXT) and Wingate Anaerobic Test (WAnT', 'BDNF levels', 'BDNF response to Wingate and Graded Exercise Test']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",,0.00893718,"At stage 0, an increase in BDNF concentration was observed in HIFT (33%; p < 0.05), HIPT (36%; p < 0.05) and HIIT (38%; p < 0.05) after GXT.","[{'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Murawska-Ciałowicz', 'Affiliation': 'Physiology and Biochemistry Department, University School of Physical Education, Wrocław, Poland. eugenia.murawska-cialowicz@awf.wroc.pl.'}, {'ForeName': 'Gilmara Gomes', 'Initials': 'GG', 'LastName': 'de Assis', 'Affiliation': 'Department of Molecular Biology, Gdansk University of Physical Education and Sport, Gdańsk, Poland.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': 'Escola Superior Desporto E Lazer, Instituto Politécnico de Viana Do Castelo, Viana do Castelo, Portugal.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Feito', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, USA.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Stastny', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Zuwała-Jagiełło', 'Affiliation': 'Department of Pharmaceutical Biochemistry, Wroclaw Medical University, Wrocław, Poland.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Bibrowicz', 'Affiliation': 'Polish Strength & Conditioning Association, Wrocław, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Wolański', 'Affiliation': 'Physiology and Biochemistry Department, University School of Physical Education, Wrocław, Poland.'}]",Scientific reports,['10.1038/s41598-021-88069-y']
1114,33846875,Web-based cognitive behavior therapy for chronic pain patients with aberrant drug-related behavior: How did it work and for whom?,"This study explored mediating pathways, moderating factors, and moderated mediation effects of a web-based, cognitive behavioral therapy (CBT) intervention for chronic pain patients with aberrant drug-related behavior (ADRB). In a 2-arm RCT, patients with chronic pain who screened positive for ADRB received treatment-as-usual (TAU, n = 55) or TAU plus a 12-week, web-based CBT intervention (n = 55). Assessments were conducted at weeks 4, 8, and 12, and at 1- and 3-months post intervention. Web-CBT significantly reduced pain catastrophizing, which, in turn, reduced pain interference and pain severity via a pathway of pain catastrophizing. Web-CBT also significantly reduced ADRB both directly and indirectly by reducing pain catastrophizing. For pain interference and pain severity, web-CBT was more effective than TAU for younger patients (≤ age 50). For pain severity, web-CBT was more effective for both younger patients (≤ age 50), and those with a lifetime substance use disorder. Findings suggest that web-CBT's positive impact on pain outcomes and ADRB are mediated by its effect on pain catastrophizing, and its treatment effects may be most robust for younger patients and those with histories of substance dependence.",2021,"For pain interference and pain severity, web-CBT was more effective than TAU for younger patients (≤ age 50).","['patients with chronic pain who screened positive for ADRB', 'younger patients and those\xa0with histories of substance dependence', 'chronic pain patients with aberrant drug-related behavior (ADRB', 'chronic pain patients with aberrant drug-related behavior']","['TAU plus a 12-week, web-based CBT intervention', 'cognitive behavioral therapy (CBT) intervention', 'Web-based cognitive behavior therapy']","['pain outcomes and ADRB', 'pain interference and pain severity', 'pain catastrophizing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038580', 'cui_str': 'Substance dependence'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}]",,0.0148385,"For pain interference and pain severity, web-CBT was more effective than TAU for younger patients (≤ age 50).","[{'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Biomedical Data Science, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA. Haiyi.Xie@dartmouth.edu.'}, {'ForeName': 'Honoria', 'Initials': 'H', 'LastName': 'Guarino', 'Affiliation': 'Graduate School of Public Health and Health Policy, City University of New York, New York, NY, USA.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Moore', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Acosta', 'Affiliation': 'Graduate School of Public Health and Health Policy, City University of New York, New York, NY, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Budney', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rosenblum', 'Affiliation': 'NDRI-USA, New York, NY, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Marsch', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Chunki', 'Initials': 'C', 'LastName': 'Fong', 'Affiliation': 'Graduate School of Public Health and Health Policy, City University of New York, New York, NY, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00219-9']
1115,33854132,TMS-EEG signatures of glutamatergic neurotransmission in human cortex.,"Neuronal activity in the brain reflects an excitation-inhibition balance that is regulated predominantly by glutamatergic and GABAergic neurotransmission, and often disturbed in neuropsychiatric disorders. Here, we tested the effects of a single oral dose of two anti-glutamatergic drugs (dextromethorphan, an NMDA receptor antagonist; perampanel, an AMPA receptor antagonist) and an L-type voltage-gated calcium channel blocker (nimodipine) on transcranial magnetic stimulation (TMS)-evoked electroencephalographic (EEG) potentials (TEPs) and TMS-induced oscillations (TIOs) in 16 healthy adults in a pseudorandomized, double-blinded, placebo-controlled crossover design. Single-pulse TMS was delivered to the hand area of left primary motor cortex. Dextromethorphan increased the amplitude of the N45 TEP, while it had no effect on TIOs. Perampanel reduced the amplitude of the P60 TEP in the non-stimulated hemisphere, and increased TIOs in the beta-frequency band in the stimulated sensorimotor cortex, and in the alpha-frequency band in midline parietal channels. Nimodipine and placebo had no effect on TEPs and TIOs. The TEP results extend previous pharmaco-TMS-EEG studies by demonstrating that the N45 is regulated by a balance of GABAAergic inhibition and NMDA receptor-mediated glutamatergic excitation. In contrast, AMPA receptor-mediated glutamatergic neurotransmission contributes to propagated activity reflected in the P60 potential and midline parietal induced oscillations. This pharmacological characterization of TMS-EEG responses will be informative for interpreting TMS-EEG abnormalities in neuropsychiatric disorders with pathological excitation-inhibition balance.",2021,"Perampanel reduced the amplitude of the P60 TEP in the non-stimulated hemisphere, and increased TIOs in the beta-frequency band in the stimulated sensorimotor cortex, and in the alpha-frequency band in midline parietal channels.","['human cortex', '16 healthy adults in a pseudorandomized, double-blinded']","['Perampanel', 'two anti-glutamatergic drugs (dextromethorphan, an NMDA receptor antagonist; perampanel, an AMPA receptor antagonist) and an L-type voltage-gated calcium channel blocker (nimodipine', 'Single-pulse TMS', 'placebo', 'Nimodipine and placebo', 'transcranial magnetic stimulation (TMS)-evoked electroencephalographic (EEG) potentials (TEPs) and TMS-induced oscillations (TIOs', 'Dextromethorphan']","['amplitude of the P60 TEP', 'TEPs and TIOs']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C4722020', 'cui_str': 'Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C1137054', 'cui_str': 'SQSTM1 protein, human'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",16.0,0.0557588,"Perampanel reduced the amplitude of the P60 TEP in the non-stimulated hemisphere, and increased TIOs in the beta-frequency band in the stimulated sensorimotor cortex, and in the alpha-frequency band in midline parietal channels.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Belardinelli', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'König', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Premoli', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Desideri', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Müller-Dahlhaus', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Pedro Caldana', 'Initials': 'PC', 'LastName': 'Gordon', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Zipser', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zrenner', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ziemann', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. ulf.ziemann@uni-tuebingen.de.'}]",Scientific reports,['10.1038/s41598-021-87533-z']
1116,33863260,Socio-economic differences in smoking among adolescents in a school-based smoking intervention: The X:IT II study.,"Aims:  Socio-economic inequalities in health behaviour may be influenced by health interventions. We examined whether the X:IT II intervention, aiming at preventing smoking in adolescence, was equally effective among students from different occupational social classes (OSC).  Methods:  We used data from the multi-component school-based smoking preventive intervention X:IT II, targeting 13- to 15-year-olds in Denmark. The intervention was tested in 46 schools with 2307 eligible students at baseline (response rate=86.6%) and had three main intervention components: smoke-free school time, smoke-free curriculum and parental involvement. We used a difference-in-difference design and estimated the change in current smoking after the first year of implementation in high versus low OSC. Analyses were based on available cases ( N =1190) and imputation of missing data at follow-up ( N =1967).  Results:  We found that 1% of the students from high OSC and 4.9% from low OSC were smokers at baseline (imputed data), and 8.2% of the students from high OSC and 12.2% from low OSC were smokers at follow-up. Difference-in-difference estimates were close to zero, indicating no differential trajectory.  Conclusions: As intended, the X:IT II intervention, designed to apply equally to students from all socio-economic groups, did not seem to create different trajectories in current smoking among adolescents in high and low socio-economic groups. To diminish social inequality in health, future studies should carefully consider the ability to affect all socio-economic groups equally, or even to appeal mainly to participants from lower socio-economic groups, as they are often the ones most in need of intervention.",2021,"We found that 1% of the students from high OSC and 4.9% from low OSC were smokers at baseline (imputed data), and 8.2% of the students from high OSC and 12.2% from low OSC were smokers at follow-up.","['46 schools with 2307 eligible students at baseline (response rate=86.6%) and had three main intervention components: smoke-free school time, smoke-free curriculum and parental involvement', 'adolescents in high and low socio-economic groups', 'students from different occupational social classes (OSC']",[],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0037402', 'cui_str': 'Social Class'}]",[],[],2307.0,0.027731,"We found that 1% of the students from high OSC and 4.9% from low OSC were smokers at baseline (imputed data), and 8.2% of the students from high OSC and 12.2% from low OSC were smokers at follow-up.","[{'ForeName': 'Lotus S', 'Initials': 'LS', 'LastName': 'Bast', 'Affiliation': 'University of Southern Denmark, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Lund', 'Affiliation': 'University of Southern Denmark, Denmark.'}, {'ForeName': 'Stine G', 'Initials': 'SG', 'LastName': 'LauemØller', 'Affiliation': 'University of Southern Denmark, Denmark.'}, {'ForeName': 'Simone G', 'Initials': 'SG', 'LastName': 'Kjeld', 'Affiliation': 'University of Southern Denmark, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Due', 'Affiliation': 'University of Southern Denmark, Denmark.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Andersen', 'Affiliation': 'Steno Diabetes Centre, Denmark.'}]",Scandinavian journal of public health,['10.1177/14034948211007683']
1117,33875485,Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial.,"OBJECTIVE


Insulin icodec (icodec) is a novel once-weekly basal insulin analog. This trial investigated two approaches for switching to icodec versus once-daily insulin glargine 100 units/mL (IGlar U100) in people with type 2 diabetes receiving daily basal insulin and one or more oral glucose-lowering medications.
RESEARCH DESIGN AND METHODS


This multicenter, open-label, treat-to-target phase 2 trial randomized (1:1:1) eligible basal insulin-treated (total daily dose 10-50 units) people with type 2 diabetes (HbA 1c  7.0-10.0% [53.0-85.8 mmol/mol]) to icodec with an initial 100% loading dose (in which only the first dose was doubled [icodec LD]), icodec with no loading dose (icodec NLD), or IGlar U100 for 16 weeks. Primary end point was percent time in range (TIR; 3.9-10.0 mmol/L [70-180 mg/dL]) during weeks 15 and 16, measured using continuous glucose monitoring. Key secondary end points included HbA 1c , adverse events (AEs), and hypoglycemia.
RESULTS


Estimated mean TIR during weeks 15 and 16 was 72.9% (icodec LD;  n  = 54), 66.0% (icodec NLD;  n  = 50), and 65.0% (IGlar U100;  n  = 50), with a statistically significant difference favoring icodec LD versus IGlar U100 (7.9%-points [95% CI 1.8-13.9]). Mean HbA 1c  reduced from 7.9% (62.8 mmol/mol) at baseline to 7.1% (54.4 mmol/mol icodec LD) and 7.4% (57.6 mmol/mol icodec NLD and IGlar U100); incidences and rates of AEs and hypoglycemic episodes were comparable.
CONCLUSIONS


Switching from daily basal insulin to once-weekly icodec was well tolerated and provided effective glycemic control. Loading dose use when switching to once-weekly icodec significantly increased percent TIR during weeks 15 and 16 versus once-daily IGlar U100, without increasing hypoglycemia risk.",2021,"Estimated mean TIR during weeks 15 and 16 was 72.9% (icodec LD;  n  = 54), 66.0% (icodec NLD;  n  = 50), and 65.0% (IGlar U100;  n  = 50), with a statistically significant difference favoring icodec LD versus IGlar U100 (7.9%-points [95% CI 1.8-13.9%]).","['people with type 2 diabetes receiving daily basal insulin and one or more oral glucose-lowering medications', 'dose 10-50 units) people with type 2 diabetes (HbA 1c  7.0-10.0% [53.0-85.8 mmol/mol]) to']","['basal insulin-treated (total daily', 'icodec versus once-daily insulin glargine U100 (IGlar U100', 'Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100', 'icodec with an initial 100% loading dose (in which only the first dose was doubled [icodec LD]), icodec with no loading dose (icodec NLD), or IGlar U100 for 16 weeks']","['rates of AEs and hypoglycemic episodes', 'Mean HbA 1c  reduced', 'Estimated mean TIR', 'percent time in range', 'HbA 1c , adverse events (AEs), and hypoglycemia', 'hypoglycemia risk']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.219246,"Estimated mean TIR during weeks 15 and 16 was 72.9% (icodec LD;  n  = 54), 66.0% (icodec NLD;  n  = 50), and 65.0% (IGlar U100;  n  = 50), with a statistically significant difference favoring icodec LD versus IGlar U100 (7.9%-points [95% CI 1.8-13.9%]).","[{'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'LMC Diabetes and Endocrinology, Brampton, Ontario, Canada harpreet.bajaj@lmc.ca.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center at Park Nicollet, Medical City, Minneapolis, MN.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Christoffersen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Amoolya', 'Initials': 'A', 'LastName': 'Gowda', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Isendahl', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Senior', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Silver', 'Affiliation': 'Southern New Hampshire Diabetes and Endocrinology, Nashua, NH.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Trevisan', 'Affiliation': 'Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center, Medical City, Dallas, TX.'}]",Diabetes care,['10.2337/dc20-2877']
1118,33875484,"A Randomized, Open-Label Comparison of Once-Weekly Insulin Icodec Titration Strategies Versus Once-Daily Insulin Glargine U100.","OBJECTIVE


Insulin icodec is a novel once-weekly basal insulin analog. This trial investigated the efficacy and safety of icodec using different once-weekly titration algorithms.
RESEARCH DESIGN AND METHODS


This was a phase 2, randomized, open-label, 16-week, treat-to-target study. Insulin-naive adults ( n  = 205) with type 2 diabetes and HbA 1c  7-10% while treated with oral glucose-lowering medications initiated once-weekly icodec titrations A (prebreakfast self-measured blood glucose target 80-130 mg/dL; adjustment ±21 units/week;  n  = 51), B (80-130 mg/dL; ±28 units/week;  n  = 51), or C (70-108 mg/dL; ±28 units/week;  n  = 52), or once-daily insulin glargine 100 units/mL (IGlar U100) (80-130 mg/dL; ±4 units/day;  n  = 51), all titrated weekly. Percentage of time in range (TIR) (70-180 mg/dL) during weeks 15 and 16 was measured using continuous glucose monitoring.
RESULTS


TIR improved from baseline (means: A, 57.0%; B, 55.2%; C, 51.0%; IGlar U100, 55.3%) to weeks 15 and 16 (estimated mean: A, 76.6%; B, 83.0%; C, 80.9%; IGlar U100, 75.9%). TIR was greater for titration B than for IGlar U100 (estimated treatment difference 7.08%-points; 95% CI 2.12 to 12.04;  P  = 0.005). No unexpected safety signals were observed. Level 2 hypoglycemia (<54 mg/dL) was low in all groups (0.05, 0.15, 0.38, 0.00 events per patient-year of exposure for icodec titrations A, B, and C and IGlar U100, respectively), with no episodes of severe hypoglycemia.
CONCLUSIONS


Once-weekly icodec was efficacious and well tolerated across all three titration algorithms investigated. The results for icodec titration A (80-130 mg/dL; ±21 units/week) displayed the best balance between glycemic control and risk of hypoglycemia.",2021,"Level 2 hypoglycemia (<54 mg/dL) was low in all groups (0.05, 0.15, 0.38, 0.00 events per patient-year of exposure for icodec titrations A, B, and C and IGlar U100, respectively), with no episodes of severe hypoglycemia.
",['Insulin-naïve adults ( n  = 205) with type 2 diabetes and HbA 1c  7-10% while treated with'],"['Once-Weekly Insulin Icodec Titration Strategies', 'oral glucose-lowering medications initiated once-weekly icodec titrations A (prebreakfast self-measured blood glucose target 80-130 mg/dL']","['glycemic control and risk of hypoglycemia', 'efficacy and safety', 'severe hypoglycemia', 'Percentage of time in range (TIR', 'efficacious and well tolerated', 'TIR', 'Level 2 hypoglycemia']","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}]",205.0,0.0569247,"Level 2 hypoglycemia (<54 mg/dL) was low in all groups (0.05, 0.15, 0.38, 0.00 events per patient-year of exposure for icodec titrations A, B, and C and IGlar U100, respectively), with no episodes of severe hypoglycemia.
","[{'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Endocrinology Division, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX ildiko.lingvay@utsouthwestern.edu.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Medical Research Centre, Warsaw, Poland.'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Mette M', 'Initials': 'MM', 'LastName': 'Koefoed', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Pettus', 'Affiliation': 'School of Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Stachlewska', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX.'}]",Diabetes care,['10.2337/dc20-2878']
1119,33881368,Hypnosis and Mindfulness Meditation: The Power of Suggestibility.,"Recent studies have suggested that mindfulness meditation and hypnosis are similar, but there is a lack of empirical data to support this claim. In this current study, college students were randomly assigned to a hypnosis or mindfulness meditation condition, and they were tested on the Waterloo Stanford Group Scale of Hypnotic Susceptibility, Form C. Results from this study suggest that, while under hypnotic induction and after engaging in mindfulness meditation, participants experienced similar results on the WSGC. That is, participants experienced the same bodily feelings and reactions regarding a standardized hypnotic suggestibility test.",2021,"That is, participants experienced the same bodily feelings and reactions regarding a standardized hypnotic suggestibility test.",['college students'],"['hypnosis or mindfulness meditation condition', 'Hypnosis and Mindfulness Meditation']",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],,0.0583434,"That is, participants experienced the same bodily feelings and reactions regarding a standardized hypnotic suggestibility test.","[{'ForeName': 'Michele E', 'Initials': 'ME', 'LastName': 'Gloede', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin-Milwaukee, USA.'}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'Sapp', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin-Milwaukee, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Van Susteren', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin-Milwaukee, USA.'}]",The International journal of clinical and experimental hypnosis,['10.1080/00207144.2021.1908830']
1120,33871411,"Effect of Digital Adherence Tools on Adherence to Antiretroviral Treatment Among Adults Living With HIV in Kilimanjaro, Tanzania: A Randomized Controlled Trial.","BACKGROUND


Lifelong adherence to antiretroviral treatment remains challenging for people living with HIV (PLHIV). The aim of this study was to investigate whether any of 2 digital adherence tools could improve adherence among PLHIV in Kilimanjaro, Tanzania.
METHODS


We performed a parallel 3-arm, nonblinded, randomized controlled trial with 1:1:1 allocation. We included adults aged between 18 and 65 years, living in Kilimanjaro region, and who were on antiretroviral treatment for at least 6 months. Their adherence, as judged by the study nurses, had to be suboptimal. In one arm, participants received reminder short message service (SMS) texts, followed by a question SMS. In the second arm, participants received a real-time medication monitoring (RTMM) device (Wisepill) with SMS reminders. In the third arm, participants received standard care only. The primary outcome of mean adherence over 48 weeks was compared between arms using between-group t tests in a modified intention-to-treat analysis.
RESULTS


In each arm, we randomized 83 participants: data of 82 participants in the RTMM arm, 80 in the SMS arm, and 81 in the standard care arm were analyzed. The average (over 48 weeks) adherence in the SMS, RTMM, and control arms was 89.6%, 90.6%, and 87.9% for pharmacy refill; 95.9%, 95.0%, and 95.2% for self-report in the past week; and 97.5%, 96.6%, and 96.9% for self-report in the past month, respectively (P values not statistically significant).
CONCLUSIONS


Receiving reminder SMS or RTMM combined with feedback about adherence levels and discussion of strategies to overcome barriers to adherence did not improve adherence to treatment and treatment outcome in PLHIV.
CLINICAL TRIAL NUMBER


PACTR201712002844286.",2021,"adherence in the SMS, RTMM and control arm was 89.6%, 90.6% and 87.9% for pharmacy refill; 95.9%, 95.0% and 95.2% for self-report in the past week; and in the past month 97.5%, 96.6% and 96.9% (p-values not statistically significant).
","['83 participants: data of 82 participants in the RTMM arm, 80 in the SMS-arm and 81 in the standard care arm were analyzed', 'adults living with HIV in Kilimanjaro, Tanzania', 'people living with HIV (PLHIV', 'adults aged between 18 and 65 years, living in Kilimanjaro Region, and who were on ART for at least six months']","['real-time medication monitoring (RTMM) device (Wisepill®) with SMS-reminders', 'digital adherence tools (DAT', 'Digital Adherence Tools', 'reminder short message service (SMS)-texts followed by a question-SMS', 'antiretroviral treatment (ART']","['adherence', 'mean adherence']","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085421', 'cui_str': 'Medication monitoring'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085421', 'cui_str': 'Medication monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",83.0,0.464956,"adherence in the SMS, RTMM and control arm was 89.6%, 90.6% and 87.9% for pharmacy refill; 95.9%, 95.0% and 95.2% for self-report in the past week; and in the past month 97.5%, 96.6% and 96.9% (p-values not statistically significant).
","[{'ForeName': 'I Marion', 'Initials': 'IM', 'LastName': 'Sumari-de Boer', 'Affiliation': 'Bioinformatics Unit, Kilimanjaro Clinical Research Institute, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Kennedy M', 'Initials': 'KM', 'LastName': 'Ngowi', 'Affiliation': 'Bioinformatics Unit, Kilimanjaro Clinical Research Institute, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Tolbert B', 'Initials': 'TB', 'LastName': 'Sonda', 'Affiliation': 'Bioinformatics Unit, Kilimanjaro Clinical Research Institute, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Francis M', 'Initials': 'FM', 'LastName': 'Pima', 'Affiliation': 'Bioinformatics Unit, Kilimanjaro Clinical Research Institute, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Lyidia V', 'Initials': 'LV', 'LastName': 'Masika Bpharm', 'Affiliation': 'Department of Pharmacy, Kilimanjaro Christian Medical Centre, Moshi, Tanzania, United Republic of Tanzania.'}, {'ForeName': 'Mirjam A G', 'Initials': 'MAG', 'LastName': 'Sprangers', 'Affiliation': 'Amsterdam University Medical Centers (UMC), Location AMC, University of Amsterdam, Department of Medical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reiss', 'Affiliation': 'Amsterdam Institute for Global Health and Development (AIGHD), Amsterdam, the Netherlands.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Bioinformatics Unit, Kilimanjaro Clinical Research Institute, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Pythia T', 'Initials': 'PT', 'LastName': 'Nieuwkerk', 'Affiliation': 'Amsterdam University Medical Centers (UMC), Location AMC, University of Amsterdam, Department of Medical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Rob E', 'Initials': 'RE', 'LastName': 'Aarnoutse', 'Affiliation': 'Radboudumc, Radboud Institute for Health Sciences, Department of Pharmacy, Nijmegen, the Netherlands.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002695']
1121,33855805,Evaluation of the Potential Effect of Iptakalim Hydrochloride on the QT Interval in Single- and Multiple-Ascending-Dose Studies Using Concentration-QTc Analysis.,"Cardiotoxicity has been one of the most common causes of withdrawal of drugs from the market, and prolongation of the QT interval is one of the manifestations of drug cardiotoxicity. Iptakalim hydrochloride (ITKL) is a selective ATP-sensitive potassium channel opener used to treat hypertension. It is crucial to assess the risk of cardiac repolarization of ITKL in clinical trials. This study was conducted to determine the effect of ITKL on corrected QT (QTc) interval. A randomized, double-blind, placebo-controlled single- and multidose regimen was carried out to investigate the QTc and ITKL concentration correlation. ITKL was administered at doses of 5, 10, 15, and 20 mg with single oral administration and 10 and 20 mg with multiple oral administration, along with placebo, in 83 healthy subjects. Electrocardiograms (ECGs) and blood samples were collected on a preset time schedule. A ΔΔQTcF effect above 10 milliseconds was excluded at all observed plasma levels. Among them, the highest dose was 20 mg, which is twice the therapeutic dose. We concluded that ITKL did not prolong the QT interval in healthy subjects within the therapeutic dose. Retrospectively registered: The study was registered at Chinese Clinical Trial Registry with registration number ChiCTR1800014466.",2021,"Cardiotoxicity has been one of the most common causes of withdrawal of drugs from the market, and prolongation of the QT interval is one of the manifestations of drug cardiotoxicity.","['83 healthy subjects', 'healthy subjects']","['Iptakalim Hydrochloride', 'Iptakalim hydrochloride (ITKL', 'placebo', 'ITKL']","['QT interval', 'QT Interval', 'corrected QT (QTc) interval', 'Electrocardiograms (ECGs) and blood samples', 'QTc and ITKL concentration correlation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1571168', 'cui_str': 'iptakalim'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1571168', 'cui_str': 'iptakalim'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",83.0,0.208077,"Cardiotoxicity has been one of the most common causes of withdrawal of drugs from the market, and prolongation of the QT interval is one of the manifestations of drug cardiotoxicity.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Bai', 'Affiliation': ""Chinese People's Liberation Army General Hospital, Medicine Clinical Research Center, Beijing, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Chinese People's Liberation Army General Hospital, Medicine Clinical Research Center, Beijing, China.""}, {'ForeName': 'Haoyue', 'Initials': 'H', 'LastName': 'Che', 'Affiliation': ""Chinese People's Liberation Army General Hospital, Medicine Clinical Research Center, Beijing, China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Thadweik Academy of Medicine, Cardiovascular Drug Research Center, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Chinese People's Liberation Army General Hospital, Medicine Clinical Research Center, Beijing, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""Chinese People's Liberation Army General Hospital, Medicine Clinical Research Center, Beijing, China.""}]",Clinical pharmacology in drug development,['10.1002/cpdd.945']
1122,33858775,"Stress and Depressive Symptoms Are Not Associated with Overall Diet Quality, But Are Associated with Aspects of Diet Quality in Pregnant Women in South Carolina.","BACKGROUND


Poor mental health may hinder diet quality in pregnancy.
OBJECTIVE


This study 1) examined whether stress and depressive symptoms are associated with diet quality (via Healthy Eating Index [HEI] 2015 total scores and dietary intake of food groups/nutrients that align with HEI-2015 components) and 2) tested race as a moderator in the relationship between mental health and diet quality.
DESIGN


This was a cross-sectional analysis of baseline data from a randomized controlled trial collected January 2015 through January 2019 in Columbia, South Carolina. Trained staff administered demographic and psychosocial questionnaires and conducted anthropometric measures. Participants completed two 24-hour dietary recalls, which were self-administered (one on-site, one at home).
PARTICIPANTS


The Health in Pregnancy and Postpartum study was a randomized controlled trial targeting excessive gestational weight gain among pregnant women with overweight/obesity (N = 228).
MAIN OUTCOME MEASURES


The HEI-2015 total scores and food groups/nutrients that align with HEI-2015 were calculated.
STATISTICAL ANALYSES PERFORMED


Multiple linear regression models were used to estimate the relationship between mental health and HEI-2015 total scores and dietary intake of food groups or nutrients that align with HEI-2015 components. Multiplicative interaction terms of stress or depressive symptoms with race were used to determine moderation.
RESULTS


Participants' diet quality was suboptimal (M = 52.0 ± 11.7; range, 27-85). Stress was negatively associated with HEI-2015 total scores (crude but not adjusted model). Stress scores were positively associated with consumption of dairy, refined grains, and added sugars and negatively associated with total protein foods. Depressive symptoms were positively associated with consumption of dairy, refined grains, and saturated fats. Race was not a moderator.
CONCLUSIONS


Diet quality was poor overall, but stress and depressive symptoms were not associated with HEI-2015 total scores in adjusted models. Excluding dairy, stress and depressive symptoms were associated with the consumption of food groups or nutrients related to worse diet quality. These relationships should be examined longitudinally to help establish causality and inform future interventions.",2021,"Stress scores were positively associated with consumption of dairy, refined grains, and added sugars and negatively associated with total protein foods.","['Pregnant Women in South Carolina', 'January 2015 through January 2019 in Columbia, South Carolina', 'pregnant women with overweight/obesity (N\xa0= 228']",[],"['stress and depressive symptoms', 'diet quality', 'HEI-2015 total scores', 'excessive gestational weight gain', 'Stress scores', 'Depressive symptoms', 'HEI-2015 total scores and food groups/nutrients that align with HEI-2015', 'Excluding dairy, stress and depressive symptoms', 'diet quality (via Healthy Eating Index']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}]",,0.100139,"Stress scores were positively associated with consumption of dairy, refined grains, and added sugars and negatively associated with total protein foods.","[{'ForeName': 'Alycia K', 'Initials': 'AK', 'LastName': 'Boutté', 'Affiliation': ''}, {'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': ''}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Eberth', 'Affiliation': ''}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Kaczynski', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2021.02.025']
1123,33858011,"Oral CBD-rich Cannabis Induces Clinical but Not Endoscopic Response in Patients with Crohn's Disease, a Randomised Controlled Trial.","AIMS


Despite reports that medical cannabis improves symptoms in Crohn's disease [CD], controlled studies evaluating disease response are lacking. This study assessed the effect of cannabidiol [CBD]-rich cannabis oil for induction of remission in CD.
METHODS


In a double-blind, randomised, placebo-controlled, single-centre trial, patients received orally either cannabis oil containing160/40 mg/ml cannabidiol/tetrahydrocannabinol [CBD/THC] or placebo for 8 weeks. Disease parameters, including the CD activity index [CDAI], and simple endoscopic score for CD [SES-CD], were assessed before and after treatment. In a subgroup of patients, blood samples were collected for CBD and THC plasma levels.
RESULTS


The study included 56 patients, age 34.5 ± 11 years, men/women 30/26 [54/46%],30 in cannabis and 26 in placebo groups. CDAI at recruitment and after 8 weeks was 282 (interquartile range [IQR] 243-342) and 166 [IQR 82-226], and 264 [IQR 234-320] and 237 [IQR 121-271] [p <0.05] in the cannabis and placebo groups, respectively. Median quality of life [QOL] score improved from 74 for both groups at baseline to 91 [IQR 85-102] and 75 [IQR 69-88] after 8 weeks in the cannabis and placebo groups, respectively [p = 0.004]. SES-CD was 10 [IQR 7-14] and 11 [IQR7-14], and 7 [4-14] and 8 [IQR 4-12] [p = 0.75] before and after treatment, in the cannabis and placebo groups, respectively. Inflammatory markers (C-reactive protein [CRP], calprotectin) remained unchanged.
CONCLUSIONS


Eight weeks of CBD-rich cannabis treatment induced significant clinical and QOL improvement without significant changes in inflammatory parameters or endoscopic scores. The oral CBD-rich cannabis extract was well absorbed. Until further studies are available, cannabis treatment in Crohn's disease should be used only in the context of clinical trials.",2021,"Inflammatory markers (CRP, calprotectin) remained unchanged.
","[""patients with Crohn's disease"", '56 patients, age 34.5±11 years, men/women 30/26 (54/46%), 30 in cannabis and 26 in placebo groups', ""Crohn's disease (CD""]","['orally eithercannabis oil containing160/40mg/ml cannabidiol/ tetrahydrocannabinol (CBD/THC) or placebo', 'placebo', 'cannabidiol (CBD)-rich cannabis oil', 'Oral CBD-rich cannabis']","['inflammatory parameters or endoscopic scores', 'SES-CD', 'CD activity index (CDAI), and simple endoscopic score for CD (SES-CD', 'Inflammatory markers (CRP, calprotectin', 'Median QOL score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0556617', 'cui_str': 'Cannabis oil'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",56.0,0.505442,"Inflammatory markers (CRP, calprotectin) remained unchanged.
","[{'ForeName': 'Timna', 'Initials': 'T', 'LastName': 'Naftali', 'Affiliation': 'Institute of Gastroenterology and Hepatology, Meir Medical Center, KfarSaba, Israel.'}, {'ForeName': 'Lihi', 'Initials': 'L', 'LastName': 'Bar-Lev Schleider', 'Affiliation': 'Research Department, Tikun-OlamCannbit Pharmaceuticals, Tel Aviv, Israel.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Almog', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meiri', 'Affiliation': 'Department of Biology, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Konikoff', 'Affiliation': 'Institute of Gastroenterology and Hepatology, Meir Medical Center, KfarSaba, Israel.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjab069']
1124,33878350,Designing warnings for sugary drinks: A randomized experiment with Latino parents and non-Latino parents.,"Sugary drink warnings are a promising policy for reducing sugary drink consumption, but it remains unknown how to design warnings to maximize their impact overall and among diverse population groups, including parents of Latino ethnicity and parents with low English use. In 2019, we randomized US parents of children ages 2-12 (n = 1078, 48% Latino ethnicity, 13% low English use) to one topic (one of four warnings, or a neutral control), which they viewed on three designs (text-only, icon, and graphic) to assess reactions to the various warnings on sugary drinks. All warning topics were perceived as more effective than the control (average differential effect [ADE] ranged from 1.77 to 1.84 [5-point Likert scale], all p < .001). All warning topics also led to greater thinking about harms of sugary drinks (all p < .001) and lower purchase intentions (all p < .01). Compared to text-only warnings, icon (ADE = 0.18) and graphic warnings (ADE = 0.30) elicited higher perceived message effectiveness, as well as greater thinking about the harms of sugary drinks, lower perceived healthfulness, and lower purchase intentions (all p < .001). The impact of icon warnings (vs. text warnings) was stronger for parents with low English use, compared to those with high English use (p = .024). Similarly, the impact of icon (vs. text warnings) was stronger for Latino parents than non-Latino parents (p = .034). This experimental study indicates that many warning topics hold promise for behavior change and that including images with warnings could increase warning efficacy, particularly among Latino parents and parents with low English use. Clinical Trial Registration: NCT04382599.",2021,All warning topics also led to greater thinking about harms of sugary drinks (all p < .001) and lower purchase intentions (all p < .01).,"['Latino parents and non-Latino parents', 'Latino parents and parents with low English use', 'children ages 2-12 (n\u202f=\u202f1078, 48% Latino ethnicity, 13% low English use) to one topic (one of four warnings, or a neutral control']",[],"['lower purchase intentions', 'greater thinking about the harms of sugary drinks, lower perceived healthfulness, and lower purchase intentions']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0514845,All warning topics also led to greater thinking about harms of sugary drinks (all p < .001) and lower purchase intentions (all p < .01).,"[{'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA. Electronic address: mghall@unc.edu.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Center for Population and Development Studies, Harvard TH Chan School of Public Health, Cambridge, MA, USA.'}, {'ForeName': 'Isabella C A', 'Initials': 'ICA', 'LastName': 'Higgins', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Bercholz', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ana Paula C', 'Initials': 'APC', 'LastName': 'Richter', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA; Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2021.106562']
1125,33884767,"Pharmacokinetics of Ginsenoside Compound K From a Compound K Fermentation Product, CK-30, and From Red Ginseng Extract in Healthy Korean Subjects.","Natural protopanaxadiol ginsenosides exhibit low absorption in the human intestine. However, ginsenoside compound K (CK) with 1 conjugated glucose molecule exhibits favorable absorption. The purpose of this study was to compare the pharmacokinetics of ginsenoside CK from a CK fermentation product, CK-30, and from a red ginseng extract. A randomized, open-label, 2-treatment, 2×2 crossover study was conducted. The volunteers were randomly divided into 2 groups. One group received CK-30, and the other group received 2.94 g of a red ginseng extract. After a 7-day washout period, the subjects received an alternative treatment for a single dose. The pharmacokinetic parameters, including the maximum plasma concentration (C max  ) and area under the plasma concentration-time curve from time 0 to time of last measurable concentration, were calculated. The median time to reach C max  of ginsenoside CK after administration of CK-30 was 3.0 hours, whereas the corresponding value of the red ginseng extract was 10.0 hours. Compared with the red ginseng extract, CK-30 resulted in a higher systemic exposure to ginsenoside CK, with a 118.3-fold increase in C max  and a 135.1-fold increase in area under the plasma concentration-time curve from time 0 to time of last measurable concentration. The systemic exposure to ginsenoside CK was significantly higher after administration of CK-30 than red ginseng extract.",2021,"The median time to reach C max  of ginsenoside CK after administration of CK-30 was 3.0 hours, whereas the corresponding value of the red ginseng extract was 10.0 hours.",['Healthy Korean Subjects'],"['CK-30', 'red ginseng extract', 'ginsenoside compound K (CK', 'Ginsenoside Compound K From a Compound K Fermentation Product, CK-30, and From Red Ginseng Extract']","['maximum plasma concentration (C max  ) and area under the plasma concentration-time curve from time 0 to time of last measurable concentration', 'median time to reach C max  of ginsenoside CK']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0675992', 'cui_str': 'ginsenoside M1'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0044729', 'cui_str': 'Dehydrocorticosterone'}, {'cui': 'C0015852', 'cui_str': 'Fermentation'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0675992', 'cui_str': 'ginsenoside M1'}]",,0.0264035,"The median time to reach C max  of ginsenoside CK after administration of CK-30 was 3.0 hours, whereas the corresponding value of the red ginseng extract was 10.0 hours.","[{'ForeName': 'Mu Seong', 'Initials': 'MS', 'LastName': 'Ban', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sunyoung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Research Division, Mginbio Co., Ltd., Seoul National University Cancer Research Institute, Seoul, Republic of Korea.'}, {'ForeName': 'ByongYeul', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Research Division, Mginbio Co., Ltd., Seoul National University Cancer Research Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hong Keun', 'Initials': 'HK', 'LastName': 'Chung', 'Affiliation': 'Research Division, Mginbio Co., Ltd., Seoul National University Cancer Research Institute, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.949']
1126,33884414,Effects of Behavioral Weight Loss and Metformin on IGFs in Cancer Survivors: A Randomized Trial.,"CONTEXT


Higher levels of insulin-like growth factor-1 (IGF-1) are associated with increased risk of cancers and higher mortality. Therapies that reduce IGF-1 have considerable appeal as means to prevent recurrence.
DESIGN


Randomized, 3-parallel-arm controlled clinical trial.
INTERVENTIONS AND OUTCOMES


Cancer survivors with overweight or obesity were randomized to (1) self-directed weight loss (comparison), (2) coach-directed weight loss, or (3) metformin treatment. Main outcomes were changes in IGF-1 and IGF-1:IGFBP3 molar ratio at 6 months. The trial duration was 12 months.
RESULTS


Of the 121 randomized participants, 79% were women, 46% were African Americans, and the mean age was 60 years. At baseline, the average body mass index was 35 kg/m2; mean IGF-1 was 72.9 (SD, 21.7) ng/mL; and mean IGF1:IGFBP3 molar ratio was 0.17 (SD, 0.05). At 6 months, weight changes were -1.0% (P = 0.07), -4.2% (P < 0.0001), and -2.8% (P < 0.0001) in self-directed, coach-directed, and metformin groups, respectively. Compared with the self-directed group, participants in metformin had significant decreases on IGF-1 (mean difference in change: -5.50 ng/mL, P = 0.02) and IGF1:IGFBP3 molar ratio (mean difference in change: -0.0119, P = 0.011) at 3 months. The significant decrease of IGF-1 remained in participants with obesity at 6 months (mean difference in change: -7.2 ng/mL; 95% CI: -13.3 to -1.1), but not in participants with overweight (P for interaction = 0.045). There were no significant differences in changes between the coach-directed and self-directed groups. There were no differences in outcomes at 12 months.
CONCLUSIONS


In cancer survivors with obesity, metformin may have a short-term effect on IGF-1 reduction that wanes over time.",2021,"Compared to the self-directed group, participants in metformin had significant decreases on IGF-1 (mean difference in change: -5.50 ng/ml, p=0.02) and IGF1:IGFBP3 molar ratio (mean difference in change: -0.0119, p=0.011) at 3 months.","['Of the 121 randomized participants, 79% were women, 46% were African Americans, and the mean age was 60 years', 'Cancer Survivors', 'Cancer survivors with overweight or obesity']","['metformin', 'Behavioral Weight Loss and Metformin', 'self-directed weight loss (comparison), 2) coach-directed weight loss, or 3) metformin treatment']","['IGF-1 and IGF-1:IGFBP3 molar ratio', 'mean IGF1:IGFBP3 molar ratio', 'weight changes', 'average BMI', 'risk of cancers and higher mortality', 'IGF-1', 'insulin-like growth factor-1 (IGF-1', 'IGF1:IGFBP3 molar ratio', 'mean IGF-1']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",121.0,0.479751,"Compared to the self-directed group, participants in metformin had significant decreases on IGF-1 (mean difference in change: -5.50 ng/ml, p=0.02) and IGF1:IGFBP3 molar ratio (mean difference in change: -0.0119, p=0.011) at 3 months.","[{'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nisa M', 'Initials': 'NM', 'LastName': 'Maruthur', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Arlene T', 'Initials': 'AT', 'LastName': 'Dalcin', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'White', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Mueller', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nowella', 'Initials': 'N', 'LastName': 'Durkin', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hassoon', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Dina G', 'Initials': 'DG', 'LastName': 'Lansey', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Norma F', 'Initials': 'NF', 'LastName': 'Kanarek', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab266']
1127,33887240,Metformin for gestational diabetes study: metformin vs insulin in gestational diabetes: glycemic control and obstetrical and perinatal outcomes: randomized prospective trial.,"BACKGROUND


Gestational diabetes that is not properly controlled with diet has been commonly treated with insulin. In recent years, several studies have published that metformin can lead to, at least, similar obstetrical and perinatal outcomes as insulin. Nevertheless, not all clinical guidelines endorse its use, and clinical practice is heterogeneous.
OBJECTIVE


This study aimed to test whether metformin could achieve the same glycemic control as insulin and similar obstetrical and perinatal results, with a good safety profile, in women with gestational diabetes that is not properly controlled with lifestyle changes.
STUDY DESIGN


The metformin for gestational diabetes study was a multicenter, open-label, parallel arms, randomized clinical trial performed at 2 hospitals in Málaga (Spain), enrolling women with gestational diabetes who needed pharmacologic treatment. Women at the age of 18 to 45 years, in the second or third trimesters of pregnancy, were randomized to receive metformin or insulin (detemir or aspart). The main outcomes were (1) glycemic control (mean glycemia, preprandial and postprandial) and hypoglycemic episodes and (2) obstetrical and perinatal outcomes and complications (hypertensive disorders, type of labor, prematurity, macrosomia, large for gestational age, neonatal care unit admissions, respiratory distress syndrome, hypoglycemia, jaundice). Outcomes were analyzed on an intention-to-treat basis.
RESULTS


Between October 2016 and June 2019, 200 women were randomized, 100 to the insulin-treated group and 100 to the metformin-treated group. Mean fasting and postprandial glycemia did not differ between groups, but postprandial glycemia was significantly better after lunch or dinner in the metformin-treated-group. Hypoglycemic episodes were significantly more common in the insulin-treated group (55.9% vs 17.7% on metformin; odds ratio, 6.118; 95% confidence interval, 3.134-11.944; P=.000). Women treated with metformin gained less weight from the enrollment to the prepartum visit (36-37 gestational weeks) (1.35±3.21 vs 3.87±3.50 kg; P=.000). Labor inductions (45.7% [metformin] vs 62.5% [insulin]; odds ratio, 0.506; 95% confidence interval, 0.283-0.903; P=.029) and cesarean deliveries (27.6% [metformin] vs 52.6% [insulin]; odds ratio, 0.345; 95% confidence interval, 0.187-0.625; P=.001) were significantly lower in the metformin-treated group. Mean birthweight, macrosomia, and large for gestational age and babies' complications were not different between treatment groups. The lower cesarean delivery rate for women treated with metformin was not associated with macrosomia, large or small for gestational age, or other complications of pregnancy.
CONCLUSION


Metformin treatment was associated with a better postprandial glycemic control than insulin for some meals, a lower risk of hypoglycemic episodes, less maternal weight gain, and a low rate of failure as an isolated treatment. Most obstetrical and perinatal outcomes were similar between groups.",2021,"Mean fasting and postprandial glycemia did not differ between groups, but postprandial glycemia was significantly better after lunch and/or dinner in the metformin-treated-group.","['women with gestational diabetes not properly controlled with lifestyle changes', 'gestational diabetes', 'Women aged 18-45 years, in the second or third trimesters of pregnancy', 'Between 2016-October and 2019-June 200 women', 'two hospitals in Málaga (Spain), enrolling women with GDM who needed pharmacological treatment']","['metformin', 'metformin-treated group', 'metformin or insulin (Detemir and/or Aspart', 'Metformin']","['obstetrical and perinatal outcomes and complications (hypertensive disorders, type of labor, prematurity, macrosomia, large for gestational age, neonatal care unit admissions, respiratory distress syndrome, hypoglycemia, jaundice', 'Mean birth weight, macrosomia and large for gestational age', 'Mean fasting and postprandial glycemia', 'weight', 'glycemic control (mean glycemia, pre-prandial and postprandial) and hypoglycemic episodes, and 2', 'Hypoglycemic episodes', 'Labor inductions', 'cesarean delivery rate', 'postprandial glycemic control', 'maternal weight gain', 'cesarean deliveries', 'postprandial glycemia']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0537270', 'cui_str': 'insulin detemir'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}]","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",200.0,0.113687,"Mean fasting and postprandial glycemia did not differ between groups, but postprandial glycemia was significantly better after lunch and/or dinner in the metformin-treated-group.","[{'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Picón-César', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Málaga, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Molina-Vega', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Málaga, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Suárez-Arana', 'Affiliation': 'Department of Obstetrics and Gynecology, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga, Málaga, Spain.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'González-Mesa', 'Affiliation': 'Department of Obstetrics and Gynecology, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga, Málaga, Spain; Universidad de Málaga, Málaga, Spain.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Sola-Moyano', 'Affiliation': 'Department of Obstetrics and Gynecology, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Málaga, Spain.'}, {'ForeName': 'Reyes', 'Initials': 'R', 'LastName': 'Roldan-López', 'Affiliation': 'Department of Neonatology, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga, Málaga, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Romero-Narbona', 'Affiliation': 'Department of Neonatology, Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Málaga, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Olveira', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga, Málaga, Spain; Universidad de Málaga, Málaga, Spain; CIBER de Diabetes y Enfermedades Metabólicas, Madrid, Spain. Electronic address: gabrielm.olveira.sspa@juntadeandalucia.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Málaga, Spain; Universidad de Málaga, Málaga, Spain; CIBER de Fisiopatología de la Obesidad y la Nutrición, Madrid, Spain. Electronic address: fjtinahones@uma.es.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'González-Romero', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga, Málaga, Spain; CIBER de Diabetes y Enfermedades Metabólicas, Madrid, Spain.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.04.229']
1128,33875738,A randomized controlled trial of ovarian reserve preservation and hemostasis during ovarian cystectomy.,"The preservation of ovarian reserve during laparoendoscopic single-site (LESS) ovarian cystectomy is crucial for reproductive-age women. This study was a single-blinded, single-center, and randomized controlled trial to evaluate the effect of hemostatic agents on the preservation of ovarian reserve and hemostasis during LESS ovarian cystectomy. Patients with unilateral ovarian cyst were randomized to the hemostatic agent and coagulation groups according to the hemostasis method. Afterwards, the patients underwent LESS ovarian cystectomy, and hemostasis was performed after ovarian cyst excision according to the assigned hemostasis method. If hemostasis was not completed within 10 min. After discharge, the patients were followed until 3 months after surgery. We compared the hemoglobin, anti-Müllerian hormone (AMH) levels, and ovarian volumes before surgery, and 2 days, 1 week, and 3 months after surgery (3 M-POST), and the decline ratio between the two groups. The decline ratio of serum AMH levels was greater at 3 M-POST in the coagulation than in the hemostatic agent group (median intention-to-treat [ITT], - 36.7 vs. - 13.3%; per-protocol [PP], - 36.8 vs. - 13.3%; P < 0.05). Notably, the difference of the decline ratio of serum AMH levels was only shown in endometriosis patients (median; ITT, - 50.7 vs. - 14.4%; PP, - 50.7% vs. - 14.4%; P < 0.05), while there was no difference in non-endometriosis patients. In conclusion, Hemostatic agents may be non-inferior to bipolar coagulation for preserving ovarian reserve and hemostasis during LESS ovarian cystectomy, in particular, for endometriosis patients. (Trial registry: ClinicalTrials.gov Identifier NCT03374397).",2021,"The decline ratio of serum AMH levels was greater at 3 M-POST in the coagulation than in the hemostatic agent group (median intention-to-treat [ITT], - 36.7 vs. - 13.3%; per-protocol [PP], - 36.8 vs. - 13.3%; P < 0.05).","['Patients with unilateral ovarian cyst', 'reproductive-age women']","['hemostatic agents', 'laparoendoscopic single-site (LESS) ovarian cystectomy', 'ovarian reserve preservation and hemostasis during ovarian cystectomy', 'hemostatic agent and coagulation']","['hemoglobin, anti-Müllerian hormone (AMH) levels, and ovarian volumes', 'decline ratio of serum AMH levels', 'ovarian reserve and hemostasis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0029927', 'cui_str': 'Cyst of ovary'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0019120', 'cui_str': 'Hemostatic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0195488', 'cui_str': 'Removal of ovarian cyst'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}]",,0.456455,"The decline ratio of serum AMH levels was greater at 3 M-POST in the coagulation than in the hemostatic agent group (median intention-to-treat [ITT], - 36.7 vs. - 13.3%; per-protocol [PP], - 36.8 vs. - 13.3%; P < 0.05).","[{'ForeName': 'Soo Jin', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-Ro Jongno-Gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Aeran', 'Initials': 'A', 'LastName': 'Seol', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-Ro Jongno-Gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Nara', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, 06135, Republic of Korea.'}, {'ForeName': 'Seungmee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Keimyung University School of Medicine, Daegu, 41931, Republic of Korea.'}, {'ForeName': 'Hee Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-Ro Jongno-Gu, Seoul, 03080, Republic of Korea. bboddi0311@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Scientific reports,['10.1038/s41598-021-87965-7']
1129,33875729,Prefrontal high definition cathodal tDCS modulates executive functions only when coupled with moderate aerobic exercise in healthy persons.,"Transcranial direct current stimulation (tDCS) is a promising tool to enhance cognitive performance. However, its effectiveness has not yet been unequivocally shown. Thus, here we tested whether coupling tDCS with a bout of aerobic exercise (AE) is more effective in modulating cognitive functions than tDCS or AE alone. One hundred twenty-two healthy participants were assigned to five randomized controlled crossover experiments. Two multimodal target experiments (EXP-4: anodal vs. sham tDCS during AE; EXP-5: cathodal vs. sham tDCS during AE) investigated whether anodal (a-tDCS) or cathodal tDCS (c-tDCS) applied during AE over the left dorsolateral prefrontal cortex (left DLPFC) affects executive functioning (inhibition ability). In three unimodal control experiments, the participants were either stimulated (EXP-1: anodal vs. sham tDCS, EXP-2: cathodal vs. sham tDCS) or did AE (EXP-3: AE vs. active control). Participants performed an Eriksen flanker task during ergometer cycling at moderate intensity (in EXP. 3-5). Only c-tDCS during AE had a significant adverse effect on the inhibition task, with decreased accuracy. This outcome provides preliminary evidence that c-tDCS during AE over the left DLPFC might effectively modulate inhibition performance compared to c-tDCS alone. However, more systematic research is needed in the future.",2021,"Only c-tDCS during AE had a significant adverse effect on the inhibition task, with decreased accuracy.","['healthy persons', 'One hundred twenty-two healthy participants']","['Transcranial direct current stimulation (tDCS', 'anodal (a-tDCS) or cathodal tDCS (c-tDCS', 'stimulated (EXP-1: anodal vs. sham tDCS, EXP-2: cathodal vs. sham tDCS) or did AE (EXP-3: AE vs. active control', 'aerobic exercise (AE']",['inhibition performance'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",122.0,0.0789329,"Only c-tDCS during AE had a significant adverse effect on the inhibition task, with decreased accuracy.","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Thomas', 'Affiliation': 'Department for Sports Psychology, Institute for Sport Science, Johannes Gutenberg-University Mainz, Albert Schweitzer Straße 22, 55128, Mainz, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Steinberg', 'Affiliation': 'School of Kinesiology, Louisiana State University, 1246 Pleasant Hall, Baton Rouge, LA, 70803, USA. fsteinberg@lsu.edu.'}, {'ForeName': 'Nils Henrik', 'Initials': 'NH', 'LastName': 'Pixa', 'Affiliation': 'Department for Neuromotor Behavior and Exercise, Institute of Sport and Exercise Sciences, Westfälische Wilhelms University Münster, Horstmarer Landweg 62b, 48149, Münster, Germany.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Department for Sports Psychology, Institute for Sport Science, Johannes Gutenberg-University Mainz, Albert Schweitzer Straße 22, 55128, Mainz, Germany.'}, {'ForeName': 'Ming-Yang', 'Initials': 'MY', 'LastName': 'Cheng', 'Affiliation': 'School of Psychology, Shanghai University of Sport, No. 650 Qingyuan Ring Road, Yangpu District, Shanghai, 200438, China.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doppelmayr', 'Affiliation': 'Department for Sports Psychology, Institute for Sport Science, Johannes Gutenberg-University Mainz, Albert Schweitzer Straße 22, 55128, Mainz, Germany.'}]",Scientific reports,['10.1038/s41598-021-87914-4']
1130,33865691,Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults (EXIT-CJS).,"The EXIT-CJS (N = 1005) multisite open-label randomized controlled trial will compare retention and effectiveness of extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) to treat opioid use disorder (OUD) among criminal justice system (CJS)-involved adults in six U.S. locales (New Jersey, New York City, Delaware, Oregon, Connecticut, and New Hampshire). With a pragmatic, noninferiority design, this study hypothesizes that XR-B (n = 335) will be noninferior to XR-NTX (n = 335) in retention-in-study-medication treatment (the primary outcome), self-reported opioid use, opioid-positive urine samples, opioid overdose events, and CJS recidivism. In addition, persons with OUD not eligible or interested in the RCT will be recruited into an enhanced treatment as usual arm (n = 335) to examine usual care outcomes in a quasi-experimental observational cohort.",2021,"The EXIT-CJS (N = 1005) multisite open-label randomized controlled trial will compare retention and effectiveness of extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) to treat opioid use disorder (OUD) among criminal justice system (CJS)-involved adults in six U.S. locales (New Jersey, New York City, Delaware, Oregon, Connecticut, and New Hampshire).","['CJS-involved adults (EXIT-CJS', 'persons with OUD not eligible or interested in the RCT']","['buprenorphine vs. naltrexone opioid', 'XR-NTX', 'self-reported opioid use, opioid-positive urine samples, opioid', 'extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX']","['overdose events, and CJS recidivism']","[{'cui': 'C0086072', 'cui_str': 'Criminal Justice'}, {'cui': 'C0449915', 'cui_str': 'System involved'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0086072', 'cui_str': 'Criminal Justice'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}]",1005.0,0.10366,"The EXIT-CJS (N = 1005) multisite open-label randomized controlled trial will compare retention and effectiveness of extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) to treat opioid use disorder (OUD) among criminal justice system (CJS)-involved adults in six U.S. locales (New Jersey, New York City, Delaware, Oregon, Connecticut, and New Hampshire).","[{'ForeName': 'Elizabeth Needham', 'Initials': 'EN', 'LastName': 'Waddell', 'Affiliation': 'School of Public Health and OHSU School of Medicine, Oregon Health & Science University, United States of America.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Springer', 'Affiliation': 'Dartmouth College, United States of America.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Marsch', 'Affiliation': 'Dartmouth College, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farabee', 'Affiliation': 'NYU Grossman SOM, United States of America.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, United States of America.'}, {'ForeName': 'Amesika', 'Initials': 'A', 'LastName': 'Nyaku', 'Affiliation': 'The State University of New Jersey, New Jersey Medical School, United States of America.'}, {'ForeName': 'Rusty', 'Initials': 'R', 'LastName': 'Reeves', 'Affiliation': 'Rutgers, University Correctional Health Care, Rutgers - Robert Wood Johnson Medical School, United States of America.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Goldfeld', 'Affiliation': 'NYU Grossman SOM, United States of America.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'McDonald', 'Affiliation': 'NYU Grossman SOM, United States of America.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Malone', 'Affiliation': 'Friends Research Institute, United States of America.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Friends Research Institute, United States of America.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Saunders', 'Affiliation': 'Dartmouth College, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Monico', 'Affiliation': 'Friends Research Institute, United States of America.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute, United States of America.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'Dartmouth College, United States of America.'}, {'ForeName': 'Kasey', 'Initials': 'K', 'LastName': 'Harding', 'Affiliation': 'Community Health Center, Inc, United States of America.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Violette', 'Affiliation': 'Connecticut Dept. of Corrections, United States of America.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Groblewski', 'Affiliation': 'New Hampshire Dept. of Corrections, United States of America.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Martin', 'Affiliation': 'ROAD to a Better Life, United States of America.'}, {'ForeName': 'Kasey', 'Initials': 'K', 'LastName': 'Talon', 'Affiliation': 'ROAD to a Better Life, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Beckwith', 'Affiliation': 'ROAD to a Better Life, United States of America.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Suchocki', 'Affiliation': 'Clackamas County Health Centers, United States of America.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Torralva', 'Affiliation': 'CODA Inc., United States of America.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Wisdom', 'Affiliation': 'CODA Inc., United States of America.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'NYU Grossman SOM, United States of America. Electronic address: Joshua.Lee@nyulangone.org.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2021.108389']
1131,33903656,The feasibility of the PAM intervention to support treatment-adherence in people with hypertension in primary care: a randomised clinical controlled trial.,"The PAM intervention is a behavioural intervention to support adherence to anti-hypertensive medications and therefore to lower blood pressure. This feasibility trial recruited 101 nonadherent patients (54% male, mean age 65.8 years) with hypertension and high blood pressure from nine general practices in the UK. The trial had 15.5% uptake and 7.9% attrition rate. Patients were randomly allocated to two groups: the intervention group (n = 61) received the PAM intervention as an adjunct to usual care; the control group (n = 40) received usual care only. At 3 months, biochemically validated medication adherence was improved by 20% (95% CI 3-36%) in the intervention than control, and systolic blood pressure was reduced by 9.16 mmHg (95% CI 5.69-12.64) in intervention than control. Improvements in medication adherence and reductions in blood pressure suggested potential intervention effectiveness. For a subsample of patients, improvements in medication adherence and reductions in full lipid profile (cholesterol 1.39 mmol/mol 95% CI 0.64-1.40) and in glycated haemoglobin (3.08 mmol/mol, 95% CI 0.42-5.73) favoured the intervention. A larger trial will obtain rigorous evidence about the potential clinical effectiveness and cost-effectiveness of the intervention.Trial registration Trial date of first registration 28/01/2019. ISRCTN74504989. https://doi.org/10.1186/ISRCTN74504989 .",2021,"At 3 months, biochemically validated medication adherence was improved by 20% (95% CI 3-36%) in the intervention than control, and systolic blood pressure was reduced by 9.16 mmHg (95% CI 5.69-12.64) in intervention than control.","['101 nonadherent patients (54% male, mean age 65.8\xa0years) with hypertension and high blood pressure from nine general practices in the UK', 'people with hypertension in primary care']","['PAM intervention as an adjunct to usual care; the control group (n\u2009=\u200940) received usual care only', 'PAM intervention']","['systolic blood pressure', 'glycated haemoglobin', 'full lipid profile', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",101.0,0.0616393,"At 3 months, biochemically validated medication adherence was improved by 20% (95% CI 3-36%) in the intervention than control, and systolic blood pressure was reduced by 9.16 mmHg (95% CI 5.69-12.64) in intervention than control.","[{'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Kassavou', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, University of Cambridge, Cambridge, UK. kk532@medschl.cam.ac.uk.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Mirzaei', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Shpendi', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brimicombe', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jagmohan', 'Initials': 'J', 'LastName': 'Chauhan', 'Affiliation': 'Department of Computer Science and Technology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Debi', 'Initials': 'D', 'LastName': 'Bhattacharya', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Naughton', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hardeman', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Eborall', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Van Emmenis', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'De Simoni', 'Affiliation': 'Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Amrit', 'Initials': 'A', 'LastName': 'Takhar', 'Affiliation': 'Cambridgeshire and Peterborough Clinical Commissioning Group, Cambridge, UK.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Metabolic Medicine and Chemical Pathology, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Department of Metabolic Medicine and Chemical Pathology, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Mascolo', 'Affiliation': 'Department of Computer Science and Technology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': ""Nightingale-Saunders Clinical Trials and Epidemiology Unit, King's College London, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Griffin', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McManus', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mant', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, University of Cambridge, Cambridge, UK.'}]",Scientific reports,['10.1038/s41598-021-88170-2']
1132,33892089,Key concepts in clinical epidemiology: Stepped wedge trials.,"A stepped wedge trial evaluates an intervention that is implemented over a number of time periods according to a staggered timetable. Stepped wedge trials are usually cluster randomized, the intervention being delivered at some geographical, service or other cluster level. There is considerable variety in the design and conduct of stepped wedge trials in practice. The analysis of a stepped wedge trial often assumes that the effect of the intervention is maintained at a constant level once it has been implemented. It is important when estimating this effect to adjust for a period effect or underlying secular trend, since time is confounded with intervention, and to account for the clustering of outcomes. The advantage often cited for a stepped wedge design is that every cluster ends up getting the intervention, though in any trial design we can offer the intervention preferentially to control clusters after the trial has finished. The real advantage of a stepped wedge design is likely to be practicality or statistical efficiency.",2021,"The advantage often cited for a stepped wedge design is that every cluster ends up getting the intervention, though in any trial design we can offer the intervention preferentially to control clusters after the trial has finished.",['clinical epidemiology'],[],[],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}]",[],[],,0.0952518,"The advantage often cited for a stepped wedge design is that every cluster ends up getting the intervention, though in any trial design we can offer the intervention preferentially to control clusters after the trial has finished.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hooper', 'Affiliation': 'Institute of Population Health Sciences, Queen Mary University of London, London, UK. Electronic address: r.l.hooper@qmul.ac.uk.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2021.04.003']
1133,33863751,A Type 2 Diabetes Subtype Responsive to ACCORD Intensive Glycemia Treatment.,"OBJECTIVE


Current type 2 diabetes (T2D) management contraindicates intensive glycemia treatment in patients with high cardiovascular disease (CVD) risk and is partially motivated by evidence of harms in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Heterogeneity in response to intensive glycemia treatment has been observed, suggesting potential benefit for some individuals.
RESEARCH DESIGN AND METHODS


ACCORD was a randomized controlled trial that investigated whether intensively treating glycemia in individuals with T2D would reduce CVD outcomes. Using a novel approach to cluster HbA 1c  trajectories, we identified groups in the intensive glycemia arm with modified CVD risk. Genome-wide analysis and polygenic score (PS) were developed to predict group membership. Mendelian randomization was performed to infer causality.
RESULTS


We identified four clinical groupings in the intensive glycemia arm, and clinical group 4 (C4) displayed fewer CVD (hazard ratio [HR] 0.34;  P   =  2.01 × 10 -3 ) and microvascular outcomes (HR 0.86;  P   =  0.015) than those receiving standard treatment. A single-nucleotide polymorphism, rs220721, in  MAS1  reached suggestive significance in C4 ( P   =  4.34  ×  10 -7 ). PS predicted C4 with high accuracy (area under the receiver operating characteristic curve 0.98), and this predicted C4 displayed reduced CVD risk with intensive versus standard glycemia treatment (HR 0.53;  P   =  4.02 × 10 -6 ), but not reduced risk of microvascular outcomes ( P   <  0.05). Mendelian randomization indicated causality between PS, on-trial HbA 1c , and reduction in CVD outcomes ( P   <  0.05).
CONCLUSIONS


We found evidence of a T2D clinical group in ACCORD that benefited from intensive glycemia treatment, and membership in this group could be predicted using genetic variants. This study generates new hypotheses with implications for precision medicine in T2D and represents an important development in this landmark clinical trial warranting further investigation.",2021,"A single-nucleotide polymorphism, rs220721, in  MAS1  reached suggestive significance in C4 ( P   =  4.34  ×  10 -7 ).","['individuals with T2D would reduce CVD outcomes', 'patients with high cardiovascular disease (CVD) risk']",['Current type 2 diabetes (T2D) management contraindicates intensive glycemia treatment'],"['CVD risk', 'microvascular outcomes', 'Genome-wide analysis and polygenic score (PS', 'CVD outcomes', 'risk of microvascular outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.139569,"A single-nucleotide polymorphism, rs220721, in  MAS1  reached suggestive significance in C4 ( P   =  4.34  ×  10 -7 ).","[{'ForeName': 'Arshiya', 'Initials': 'A', 'LastName': 'Mariam', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Miller-Atkins', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Pantalone', 'Affiliation': 'Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zimmerman', 'Affiliation': 'Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Barnard', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Kattan', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Joslin Diabetes Center and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'McLeod', 'Affiliation': 'Taneja College of Pharmacy, University of South Florida, Tampa, FL.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'Joslin Diabetes Center and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wagner', 'Affiliation': 'Center for Pharmacogenomics and Individualized Therapy, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Alison A', 'Initials': 'AA', 'LastName': 'Motsinger-Reif', 'Affiliation': 'Biostatistics and Computational Biology Branch, National Institute of Environmental Health Sciences, Research Triangle Park, NC.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Rotroff', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH rotrofd@ccf.org.'}]",Diabetes care,['10.2337/dc20-2700']
1134,33877325,Effectiveness of Mobilization of the Talus and Distal Fibula in the Management of Acute Lateral Ankle Sprain.,"OBJECTIVE


Distal fibular mobilization with movement (MWM), with and without a posterior gliding fibular tape, and anteroposterior mobilization of the talus (MOB) are widely used to treat acute lateral ankle sprains. The purpose of this study was to investigate the short-term and long-term relative effectiveness of these techniques.
METHODS


In this double-blind randomized controlled trial, 45 amateur soccer players with acute (<72 hours) lateral ankle sprain were randomly allocated to 6 sessions (3/wk within the first 2 weeks) of either MWM, MWM with tape (MWMtape), or MOB. All participants also received general advice, transcutaneous electrical nerve stimulation, edema draining massage, and a program of proprioception exercises. Participant ratings of function on the Foot and Ankle Ability Measure and Patient Global Impression of Improvement Scale were the primary outcomes measured over 52 weeks. Secondary outcomes were ankle pain, pressure pain threshold, range of motion, volume, and strength.
RESULTS


MWM and MWMtape were equally effective and participants demonstrated greater function on the Foot and Ankle Ability Measure at 12 and 52 weeks when compared with those receiving MOB; however, the latter demonstrated superior function at 2 weeks. No differences between groups were observed for Patient Global Impression of Improvement Scale or any of the secondary outcomes.
CONCLUSION


There are limited differences in the short term among techniques, with the exception of better sport function with MOB. Over the longer term, the distal fibular MWM is most effective to achieve activities of daily living and sport function when added to usual physical therapy care. The addition of a posterior gliding fibular tape provides no additional benefit.
IMPACT


Distal fibular mobilization with movement may be the most appropriate choice of treatment for acute lateral ankle sprain to achieve long-term activities of daily living and sport function. In the short term, anteroposterior mobilization of the talus offers greater improvement in sport function. The use of fibular tape provides no added benefit as an adjunct to a treatment that includes distal fibular mobilization with movement.",2021,"RESULTS


Participants receiving MWM and MWMtape were equally effective and demonstrated greater function on FAAM at 12 and 52 weeks when compared with those receiving MOB; however, the latter demonstrated superior function at 2 weeks.","['acute lateral ankle sprains', 'Acute Lateral Ankle Sprain', '45 amateur soccer players with acute (<72\xa0hours) lateral ankle sprain']","['Distal fibula mobilization with movement (MWM), with and without a posterior gliding fibular tape, and anteroposterior mobilization of the talus (MOB', 'MWM, MWM with tape (MWMtape), or MOB', 'proprioception exercises', 'general advice, transcutaneous electrical nerve stimulation (TENS), edema draining massage', 'fibular tape']","['function on FAAM', 'ankle pain, pressure pain threshold, range of motion, volume, and strength', 'activities of daily living (ADL) and sport function', 'Participant ratings of function on the Foot and Ankle Ability Measure (FAAM) and Patient Global Impression of Improvement Scale (PGI-I', 'sport function']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C1292423', 'cui_str': '72 hours'}]","[{'cui': 'C0588197', 'cui_str': 'Bone structure of distal fibula'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0039277', 'cui_str': 'Bone structure of talus'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0238656', 'cui_str': 'Ankle pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",45.0,0.108939,"RESULTS


Participants receiving MWM and MWMtape were equally effective and demonstrated greater function on FAAM at 12 and 52 weeks when compared with those receiving MOB; however, the latter demonstrated superior function at 2 weeks.","[{'ForeName': 'Loitzun', 'Initials': 'L', 'LastName': 'Izaola-Azkona', 'Affiliation': 'Physiotherapy Department, University of Deusto, San Sebastian, Spain.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences, Department of Physiotherapy, University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Iratxe', 'Initials': 'I', 'LastName': 'Olabarrieta-Eguia', 'Affiliation': 'Mugi Fisioterapia, Sabino Arana 30, Sopelana, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Saez', 'Affiliation': 'Research Group on Statistics, Econometrics and Health (GRECS), University of Girona, Girona, Spain.'}, {'ForeName': 'Ion', 'Initials': 'I', 'LastName': 'Lascurain-Aguirrebeña', 'Affiliation': 'Physiotherapy, Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country UPV/EHU, Leioa, Spain.'}]",Physical therapy,['10.1093/ptj/pzab111']
1135,33887241,Induction of labor at term with vaginal misoprostol or a prostaglandin E2 pessary: a noninferiority randomized controlled trial.,"BACKGROUND


Induction of labor is among the most common procedures for pregnant women. Only a few randomized clinical trials with relatively small samples have compared misoprostol with dinoprostone. Although their efficacy seems similar, their safety profiles have not been adequately evaluated, and economic data are sparse.
OBJECTIVE


This study aimed to test the noninferiority of vaginal misoprostol (prostaglandin E1) (25 μg) to a slow-release dinoprostone (prostaglandin E2) pessary (10 μg) for induction of labor with an unfavorable cervix at term.
STUDY DESIGN


This was an open-label multicenter randomized noninferiority trial at 4 university hospitals of the Research Group in Obstetrics and Gynecology between 2012 and 2015. We recruited women who underwent induction of labor for medical reasons, those with a Bishop score of ≤5 at ≥36 weeks' gestation, and those with a cephalic-presenting singleton pregnancy with no previous cesarean delivery. Women were randomly allocated to receive either vaginal misoprostol at 4-hour intervals (25 μg) or a 10-mg slow-release dinoprostone pessary. The primary outcome was the total cesarean delivery rate. Noninferiority was defined as a difference in the cesarean delivery rates between the groups of no more than 5%. Secondary outcomes included neonatal and maternal morbidity, vaginal delivery at <24 hours after starting the induction of labor process, and maternal satisfaction.
RESULTS


The study included 1674 randomized women. The per-protocol analysis included 790 women in each group. The total cesarean delivery rates were 22.1% (n=175) in the misoprostol group and 19.9% (n=157) in the dinoprostone group, a difference of 2.2% (with an upper-bound 95% confidence limit of 5.6%) (P=.092). Results in the intention-to-treat analysis were similar. Neonatal and maternal morbidity rates were similar between groups. Vaginal delivery within 24 hours was significantly higher in the misoprostol group (59.3% vs 45.7%; P<.001) as was maternal satisfaction, assessed in the postpartum period by a visual analog scale (mean score, 7.1±2.4 vs 5.8±3.1; P<.001).
CONCLUSION


The noninferiority of a 25-μg dose of vaginal misoprostol every 4 hours to the dinoprostone pessary for cesarean delivery rates after induction of labor at term could not be demonstrated, although the confidence limit of the difference barely exceeded the noninferiority margin. Nonetheless, given the small difference between these cesarean delivery rates and the similarity of neonatal and maternal morbidity rates in this large study, the clinical risk-to-benefit ratio justifies the use of both drugs.",2021,"Vaginal delivery within 24 hours was significantly higher in the misoprostol group (59.3% vs 45.7%, P<.001) as was maternal satisfaction, assessed in the postpartum period by a visual analog scale: mean score: 7.1 (SD 2.4) vs 5.8 (3.1), P<.001.
","['women with labor induced for medical reasons, a Bishop score ≤ 5 at ≥ 36 weeks, and a cephalic-presenting singleton pregnancy with no prior cesarean delivery', '4 university hospitals of the Research Group in Obstetrics and Gynecology (GROG) between 2012 and 2015', 'pregnant women', '1674 randomized women']","['Vaginal Misoprostol', 'misoprostol', 'vaginal misoprostol', '25-μg vaginal misoprostol', 'dinoprostone', 'vaginal misoprostol (PGE1) (25 μg) to a slow-release dinoprostone (PGE2) pessary', '10-mg slow-release dinoprostone pessary']","['Neonatal and maternal morbidity', 'Vaginal delivery', 'cesarean delivery rates', 'total cesarean delivery rate', 'CD rates', 'cesarean rates and the similarity of neonatal and maternal morbidity rates', 'maternal satisfaction', 'neonatal and maternal morbidity, vaginal delivery < 24 hours after starting the induction process, and maternal satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022875', 'cui_str': 'Onset of labor induced'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",1674.0,0.178438,"Vaginal delivery within 24 hours was significantly higher in the misoprostol group (59.3% vs 45.7%, P<.001) as was maternal satisfaction, assessed in the postpartum period by a visual analog scale: mean score: 7.1 (SD 2.4) vs 5.8 (3.1), P<.001.
","[{'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Gaudineau', 'Affiliation': 'Department of Obstetrics and Gynecology, Strasbourg University Hospitals, Strasbourg, France; Department of Obstetrics and Gynecology, Princess Grace Hospital Center, Monaco.'}, {'ForeName': 'Marie-Victoire', 'Initials': 'MV', 'LastName': 'Senat', 'Affiliation': 'Department of Obstetrics and Gynecology, Public Assistance Hospitals of Paris, Bicêtre Hospital, Le Kremlin-Bicêtre, France; Centre for Research in Epidemiology and Population Health, INSERM, Paris-Saclay University, Versailles Saint-Quentin-en-Yvelines University, Villejuif, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Ehlinger', 'Affiliation': 'Centre for Epidemiology and Population Health Research, Toulouse III University, Toulouse, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Gallini', 'Affiliation': 'Clinical Epidemiology Unit, Toulouse University Hospital Center, Toulouse, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Paule de Viguier Hospital, Toulouse University Hospital Center, Toulouse, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Olivier', 'Affiliation': 'Department of Medical Pharmacology, Toulouse University Hospital Center, Toulouse, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Roth', 'Affiliation': 'Department of Obstetrics and Gynecology, Strasbourg University Hospitals, Strasbourg, France.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Orusco', 'Affiliation': 'Department of Obstetrics and Gynecology, Public Assistance Hospitals of Paris, Bicêtre Hospital, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Javoise', 'Affiliation': 'Department of Obstetrics and Gynecology, Intercommunal Hospital Center of Poissy-Saint-Germain, Poissy, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Fort', 'Affiliation': 'Department of Obstetrics and Gynecology, Intercommunal Hospital Center of Poissy-Saint-Germain, Poissy, France.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Lavergne', 'Affiliation': 'Department of Medical Pharmacology, Toulouse University Hospital Center, Toulouse, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arnaud', 'Affiliation': 'Centre for Epidemiology and Population Health Research, Toulouse III University, Toulouse, France; Clinical Epidemiology Unit, Toulouse University Hospital Center, Toulouse, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rozenberg', 'Affiliation': 'Department of Obstetrics and Gynecology, Intercommunal Hospital Center of Poissy-Saint-Germain, Poissy, France; Clinical Epidemiology, Centre for Research in Epidemiology and Population Health, INSERM, Paris-Saclay University, Montigny-le-Bretonneux, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Vayssiere', 'Affiliation': 'Centre for Epidemiology and Population Health Research, Toulouse III University, Toulouse, France; Department of Obstetrics and Gynaecology, Paule de Viguier Hospital, Toulouse University Hospital Center, Toulouse, France. Electronic address: christophe.vayssiere@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.04.226']
1136,33867461,"Efficacy of Microplasma Radiofrequency Versus CO2 Laser Therapy for Seborrheic Keratoses: A Randomized, Intraindividual Comparative Study.",,2021,,['Seborrheic Keratoses'],['Microplasma Radiofrequency Versus CO2 Laser Therapy'],[],[],"[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0327522,,"[{'ForeName': 'Mu-Lan', 'Initials': 'ML', 'LastName': 'Fu', 'Affiliation': 'Medical School, Nantong University, Jiangsu, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Cosmetology, The Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Cosmetology, The Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Cosmetology, The Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002896']
1137,33867429,A Quasi-Experimental Study of the Effect of Ginger Tea on Preventing Nausea and Vomiting in Patients With Gynecological Cancers Receiving Cisplatin-Based Regimens.,"BACKGROUND


Cancer patients receiving chemotherapy experience acute and delayed nausea and vomiting. These side effects obligate the patients to use pharmacological and nonpharmacological methods. The effect of ginger tea as an antiemetic modality on preventing chemotherapy-related nausea and vomiting has not been confirmed in previous studies.
OBJECTIVE


The aim of this study was to assess the effect of ginger tea, when given together with the standard antiemetic regimen, on preventing nausea and vomiting in patients with gynecological cancers receiving cisplatin-based regimens.
METHODS


This study used a quasi-experimental research design with 2 groups (control and intervention groups, 50 participants each). A sociodemographic and medical survey and the Modified Rhodes Index of Nausea, Vomiting, and Retching were used to collect the data. Descriptive analyses, t test, and χ2 test were used to analyze the data.
RESULTS


The total mean Modified Rhodes Index of Nausea, Vomiting, and Retching scores were lower in the intervention group in all measurements compared with the control group, and the differences between the total mean scores for symptom experience, development, and distress between the groups were statistically significant in the third (P < .05), fourth (P < .01), and fifth (P < .05) measurements. No ginger-related side effects were noted in this study.
CONCLUSIONS


Ginger tea reduced the experience, development, and distress of nausea, vomiting, and retching in the intervention group. The use of ginger tea may be recommended for chemotherapy-associated nausea and vomiting in cancer patients receiving cisplatin-based regimens.
IMPLICATIONS FOR PRACTICE


Oncology nurses can lead the implementation of ginger tea intervention to prevent chemotherapy-related nausea and vomiting.",2021,"The total mean Modified Rhodes Index of Nausea, Vomiting, and Retching scores were lower in the intervention group in all measurements compared with the control group, and the differences between the total mean scores for symptom experience, development, and distress between the groups were statistically significant in the third (P < .05), fourth (P < .01), and fifth (P < .05) measurements.","['patients with gynecological cancers receiving cisplatin-based regimens', 'cancer patients receiving cisplatin-based regimens', 'Patients With Gynecological Cancers Receiving Cisplatin-Based Regimens', 'Cancer patients receiving chemotherapy experience acute and delayed nausea and vomiting']","['Ginger tea', 'Ginger Tea', 'ginger tea']","['nausea and vomiting', 'Nausea, Vomiting, and Retching', 'experience, development, and distress of nausea, vomiting, and retching', 'total mean scores for symptom experience, development, and distress', 'side effects', 'Nausea and Vomiting', 'total mean Modified Rhodes Index of Nausea, Vomiting, and Retching scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]","[{'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0232602', 'cui_str': 'Retching'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454812', 'cui_str': 'Rhodes'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",50.0,0.0514796,"The total mean Modified Rhodes Index of Nausea, Vomiting, and Retching scores were lower in the intervention group in all measurements compared with the control group, and the differences between the total mean scores for symptom experience, development, and distress between the groups were statistically significant in the third (P < .05), fourth (P < .01), and fifth (P < .05) measurements.","[{'ForeName': 'Dhuha Y', 'Initials': 'DY', 'LastName': 'Wazqar', 'Affiliation': ""Author Affiliations: Department of Medical Surgical Nursing, Faculty of Nursing, King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia (Dr Wazqar); Department of Woman's Health and Midwifery Nursing, Faculty of Nursing, Mansoura University, Mansoura, Egypt (Dr Thabet); and Department of Medical Surgical Nursing, Faculty of Nursing, Ain Shams University, Cairo, Egypt (Dr Safwat).""}, {'ForeName': 'Hala A', 'Initials': 'HA', 'LastName': 'Thabet', 'Affiliation': ''}, {'ForeName': 'Amany M', 'Initials': 'AM', 'LastName': 'Safwat', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000939']
1138,33893744,Attitude change after a curriculum on the science and philosophy of well-being and happiness for high school students: A classroom-randomized trial.,"BACKGROUND


Multiple interventions have been tested to promote well-being in high school students, often focusing on depression prevention.
AIMS


To test the impact of a one-semester active learning curriculum covering the modern science and philosophy of well-being and happiness on attitudinal measures related to the curriculum and standard measures of depression and well-being.
SAMPLE


Subjects were first-year students in an urban high school in Beijing, China (equivalent to US tenth grade).
METHODS


Nine classrooms were randomly assigned to the intervention curriculum (n = 252), and nine classrooms were randomly assigned to a traditional psychology curriculum (n = 263). Students completed questionnaires pre- and post-semester including a Positive Attitude Scale (PAS, concerning Relatedness, Competence, Autonomy, Gratitude, Calmness, Mindfulness, and Hope), Positive and Negative Affect Scale (PANAS), Centers for Epidemiological Studies Depression Scale (CES-D), Life Satisfaction Scale (LS), Subjective Happiness Scale (SHS), Meaning in Life Questionnaire (MLQ), and a test of knowledge about well-being (Knowledge Test, KT).
RESULTS


In a hierarchical linear model, there were statistically significant intervention effects on six of the seven subscales of the PAS, on PANAS balance, and on the KT. CES-D, LS, SHS, and MLQ were improved but not significantly so. Notable overall secular trends in measures of well-being were observed, with a peak in September and nadir in April.
CONCLUSIONS


A one-semester course for high school students regarding well-being and happiness demonstrated significant changes in positive attitudes, affective balance, and knowledge about happiness. Circannual trends in well-being measures over the academic year have implications for those designing school intervention studies.",2021,"CES-D, LS, SHS, and MLQ were improved but not significantly so.","['n\xa0=\xa0252), and nine classrooms', 'Nine classrooms', 'SAMPLE\n\n\nSubjects were first-year students in an urban high school in Beijing, China (equivalent to US tenth grade']","['traditional psychology curriculum', 'intervention curriculum']","['positive attitudes, affective balance, and knowledge about happiness', 'CES-D, LS, SHS, and MLQ', 'questionnaires pre- and post-semester including a Positive Attitude Scale (PAS, concerning Relatedness, Competence, Autonomy, Gratitude, Calmness, Mindfulness, and Hope), Positive and Negative Affect Scale (PANAS), Centers for Epidemiological Studies Depression Scale (CES-D), Life Satisfaction Scale (LS), Subjective Happiness Scale (SHS), Meaning in Life Questionnaire (MLQ), and a test of knowledge about well-being (Knowledge Test, KT']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0796135', 'cui_str': 'Renpenning syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030125', 'cui_str': 'aminosalicylic acid'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",9.0,0.0331843,"CES-D, LS, SHS, and MLQ were improved but not significantly so.","[{'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Desan', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Setton', 'Affiliation': 'School of Public and International Affairs, University of Bridgeport, Connecticut, USA.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Holzer', 'Affiliation': 'InspireCorps, Inc, West Hartford, Connecticut, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, George Mason University, Alexandria, Virginia, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Psychology, Beijing High School #19, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Psychology, Beijing High School #19, Beijing, China.'}, {'ForeName': 'Baosong', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, Beijing High School #19, Beijing, China.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Weinstein', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, Beijing High School #19, Beijing, China.'}]",The British journal of educational psychology,['10.1111/bjep.12419']
1139,33884564,Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure.,"Residual or newly acquired leaks are routinely appraised after left atrial appendage closure (LAAC). The Watchman and the Amulet are the two most frequently used devices for LAAC but no randomized study has so far assessed their comparative leak rates after intervention. The ""Comparison of Amplatzer Amulet vs Watchman devices in patients undergoing left atrial appendage closure"" (Swiss-Apero, clinicaltrial.gov NCT03399851) is an academic-sponsored multicenter, randomized clinical trial comparing Amulet versus Watchman/FLX devices among patients undergoing a clinically indicated LAAC. The study is designed to assess the superiority of Amulet vs. Watchman/FLX in terms of leaks detected by cardiac computed tomography angiography (CCTA) at 45 days (primary endpoint) and 13 months (secondary endpoint) after intervention by an imaging Core Laboratory. The Swiss-Apero study is the first randomized clinical trial comparing Amulet and Watchman/FLX with respect to the prevalence of post-procedural leak as assessed with CCTA.",2021,"The ""Comparison of Amplatzer Amulet vs Watchman devices in patients undergoing left atrial appendage closure"" (Swiss-Apero, clinicaltrial.gov NCT03399851) is an academic-sponsored multicenter, randomized clinical trial comparing Amulet versus Watchman/FLX devices among patients undergoing a clinically indicated LAAC.","['patients undergoing a clinically indicated LAAC', 'patients undergoing left atrial appendage closure"" (Swiss-Apero', 'Patients Undergoing Left Atrial Appendage Closure']","['Watchman/FLX', 'Amplatzer Amulet vs Watchman devices', 'Amulet vs. Watchman/FLX', 'cardiac computed tomography angiography (CCTA', 'Amplatzer Amulet vs Watchman Device']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}, {'cui': 'C4759306', 'cui_str': 'Left atrial appendage closure'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}]","[{'cui': 'C0335390', 'cui_str': 'Watchman'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]",[],,0.148503,"The ""Comparison of Amplatzer Amulet vs Watchman devices in patients undergoing left atrial appendage closure"" (Swiss-Apero, clinicaltrial.gov NCT03399851) is an academic-sponsored multicenter, randomized clinical trial comparing Amulet versus Watchman/FLX devices among patients undergoing a clinically indicated LAAC.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Galea', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'De Marco', 'Affiliation': 'Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meneveau', 'Affiliation': 'Besancon University Hospital, EA3920, University of Burgundy Franche-Comté, Besancon, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Anselme', 'Affiliation': 'Department of Cardiology, University Hospital of Rouen, Rouen, France.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Gräni', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Adrian T', 'Initials': 'AT', 'LastName': 'Huber', 'Affiliation': 'Department of Diagnostic, Interventional and Pediatric Radiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Teiger', 'Affiliation': 'Department of Cardiology, Henri-Mondor Hospital, Public Assistance Hospitals of Paris, Créteil, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Iriart', 'Affiliation': 'Department of Pediatric and Adult Congenital Cardiology, Hôpital Cardiologique du Haut- Lévêque, CHU de Bordeaux, Bordeaux-Pessac, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Angelillis', 'Affiliation': 'Cardiac Thoracic and Vascular Department, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Brugger', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Noé', 'Initials': 'N', 'LastName': 'Corpataux', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Franzone', 'Affiliation': 'Department of Advanced Biomedical Sciences, University Federico II University, Naples, Italy.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Fischer', 'Affiliation': 'Department of Neurology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pedrazzini', 'Affiliation': 'Cardiocentro Ticino, Via Tesserete 48, 6900, Lugano, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bedogni', 'Affiliation': 'Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. marco.valgimigli@cardiocentro.org.'}]",Journal of cardiovascular translational research,['10.1007/s12265-020-10095-4']
1140,33884415,Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials.,"BACKGROUND AND AIMS


Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. Here, we evaluate the efficacy and safety of tofacitinib re-treatment following treatment interruption in patients with ulcerative colitis.
METHODS


Here, patients with clinical response to tofacitinib 10 mg b.d. induction therapy were randomised to receive placebo in OCTAVE Sustain. Those experiencing treatment failure after Week 8 of OCTAVE Sustain entered OCTAVE Open and re-initiated tofacitinib 10 mg b.d. [re-treatment subpopulation]; efficacy and safety data are presented up to Month 36 of OCTAVE Open.
RESULTS


Median time to treatment failure following interruption was 169 (95% confidence interval [CI], 94.0-179.0) and 123 [95% CI, 91.0-168.0] days for induction remitters, and induction responders but non-remitters, respectively. Following re-treatment with tofacitinib, rates (non-responder imputation after a patient discontinued; latest observation carried forward imputation after a patient advanced to a subsequent study [NRI-LOCF]) of clinical response, remission, and endoscopic improvement were 74.0%, 39.0%, and 55.0% at Month 2, and 48.5%, 37.4%, and 42.4% at Month 36, respectively. Among induction remitters and induction responders but non-remitters, clinical response rates at Month 36 were 60.6% and 42.4% [NRI-LOCF], respectively. Efficacy was recaptured regardless of prior tumour necrosis factor inhibitor failure status. The safety profile of tofacitinib 10 mg b.d. re-treatment was consistent with the overall cohort and demonstrated no new safety risks associated with exposure of ≤36 months.
CONCLUSIONS


Median time to treatment failure was numerically higher in induction remitters versus induction responders but non-remitters. Following treatment interruption, efficacy was safely and successfully recaptured with tofacitinib 10 mg b.d. re-treatment in a substantial proportion of patients [ClinicalTrials.gov:NCT01458574;NCT01470612].",2021,"CONCLUSIONS


Median time to treatment failure was numerically higher in induction remitters versus induction responders but non-remitters.","['Ulcerative Colitis', 'patients with ulcerative colitis']","['tofacitinib', 'placebo', 'Tofacitinib Retreatment']","['Efficacy and Safety', 'clinical response, remission, and endoscopic improvement', 'efficacy and safety', 'clinical response rates', 'Median time to treatment failure']","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.187667,"CONCLUSIONS


Median time to treatment failure was numerically higher in induction remitters versus induction responders but non-remitters.","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Panés', 'Affiliation': 'Inflammatory Bowel Disease Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Vermeire', 'Affiliation': 'Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Marla C', 'Initials': 'MC', 'LastName': 'Dubinsky', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Loftus', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA.'}, {'ForeName': 'Nervin', 'Initials': 'N', 'LastName': 'Lawendy', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Salese', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Chinyu', 'Initials': 'C', 'LastName': 'Su', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Modesto', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Colombel', 'Affiliation': 'Division of Gastroenterology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjab065']
1141,33870479,Acute Pain Predictors of Remote Postoperative Pain Resolution After Hand Surgery.,"INTRODUCTION


Chronic postsurgical pain (CPSP) is a global issue with high prevalence. This study compared acute pain descriptors among patients undergoing carpal tunnel release (CTR) or trigger finger release (TFR). We hypothesized worst pain intensity on postoperative day (POD) 10 would be best to predict the time to pain resolution.
METHODS


In this secondary analysis of a negative, randomized, double-blind placebo-controlled trial, adult veterans undergoing CTR or TFR were enrolled January 2012-January 2014, with data analysis February 2020-October 2020. Participants were randomized to receive minocycline 200 mg or placebo 2 h prior to the operation, then minocycline 100 mg or placebo twice daily for 5 days. The Brief Pain Inventory, assessed daily, captured three pain scores: average and worst pain over the past 24 h, and current pain intensity. Fifteen acute pain descriptors based on the pain scores (clusters, mean, median, pain scores on POD 10, and linear slopes) were compared as predictors of time to pain resolution.
RESULTS


Of 131 randomized participants, 114 (83 CTR, 31 TFR) were included. Average pain over the last 24 h reported on POD 10 best predicted time to pain cessation. Every one-point increase in the average pain score was associated with a 36.0% reduced rate of pain cessation (HR, 0.64, 95% CI 0.55-0.74, p < 0.001). Average pain on POD 10 was significantly associated with the development of CPSP at 90 days (OR 1.74, 95% CI 1.30-2.33, p value < 0.001). The optimal cutoff score for the high-risk group was determined as average pain on POD 10 ≥ 3.
CONCLUSIONS


This study validates prior work and demonstrates the importance of assessing pain severity on POD 10 to identify patients at high risk for CPSP who are most likely to benefit from early pain intervention. Future research in diverse surgical cohorts is needed to further validate pain assessment on POD 10 as a significant predictor of CPSP.",2021,"Average pain on POD 10 was significantly associated with the development of CPSP at 90 days (OR 1.74, 95% CI 1.30-2.33, p value < 0.001).","['adult veterans undergoing CTR or TFR were enrolled January 2012-January 2014, with data analysis', 'patients undergoing carpal tunnel release (CTR) or trigger finger release (TFR', 'Of 131 randomized participants, 114 (83 CTR, 31 TFR) were included']","['minocycline 200\xa0mg or placebo', 'placebo', 'minocycline 100\xa0mg or placebo']","['Acute Pain Predictors of Remote Postoperative Pain Resolution', 'pain scores (clusters, mean, median, pain scores on POD 10, and linear slopes', 'rate of pain cessation', 'pain scores: average and worst pain over the past 24\xa0h, and current pain intensity', 'average pain score', 'Average pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0196576', 'cui_str': 'Decompression of median nerve'}, {'cui': 'C0407128', 'cui_str': 'Release of trigger finger'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1123408', 'cui_str': 'Minocycline 100 MG'}]","[{'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",131.0,0.640697,"Average pain on POD 10 was significantly associated with the development of CPSP at 90 days (OR 1.74, 95% CI 1.30-2.33, p value < 0.001).","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Hah', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University, 1070 Arastradero Rd, Ste 200, Palo Alto, CA, 94304, USA. jhah@stanford.edu.'}, {'ForeName': 'Chinwe A', 'Initials': 'CA', 'LastName': 'Nwaneshiudu', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University, 1070 Arastradero Rd, Ste 200, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cramer', 'Affiliation': 'Systems Neuroscience and Pain Lab, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Carroll', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University, 1070 Arastradero Rd, Ste 200, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Curtin', 'Affiliation': 'Division of Hand and Plastic Surgery, Department of Orthopaedic Surgery, Stanford University, Stanford, CA, USA.'}]",Pain and therapy,['10.1007/s40122-021-00263-y']
1142,33870426,Foregut Exclusion Enhances Incretin and Insulin Secretion After Roux-en-Y Gastric Bypass in Adults With Type 2 Diabetes.,"INTRODUCTION


Patients with type 2 diabetes experience resolution of hyperglycemia within days after Roux-en-Y gastric bypass (RYGB) surgery. This is attributed, in part, to enhanced secretion of hindgut factors following exclusion of the gastric remnant and proximal intestine during surgery. However, evidence of the mechanisms of remission remain limited due to the challenges of metabolic evaluation during the early postoperative period. The purpose of this investigation was to determine the role of foregut exclusion in the resolution of type 2 diabetes after RYGB.
METHODS


Patients with type 2 diabetes (n = 15) undergoing RYGB had a gastrostomy tube (G-tube) placed in their gastric remnant at time of surgery. Patients were randomized to receive a mixed meal tolerance test via oral or G-tube feeding immediately prior to and 2 weeks after surgery in a repeated measures crossover design. Plasma glucose, insulin, C-peptide, incretin responses, and indices of meal-stimulated insulin secretion and sensitivity were determined.
RESULTS


Body weight, fat mass, fasting glucose and insulin, and circulating lipids were significantly decreased 2 weeks after surgery. The glycemic response to feeding was reduced as a function of total area under the curve but not after adjustment for the reduction in fasting glucose. Oral feeding significantly enhanced insulin and incretin secretion after RYGB, which was entirely ablated by G-tube feeding.
CONCLUSION


Foregut exclusion accounts for the rise in incretin and insulin secretion but may not fully explain the early improvements in glucose metabolism after RYGB surgery.",2021,"Oral feeding significantly enhanced insulin and incretin secretion after RYGB, which was entirely ablated by G-tube feeding.
","['Patients with type 2 diabetes (n=15) undergoing RYGB had a gastrostomy tube (G-tube) placed in their gastric remnant at time of surgery', 'Patients with type 2 diabetes experience resolution of hyperglycemia within days after Roux-en-Y gastric bypass (RYGB) surgery', 'Adults with Type 2 Diabetes']","['mixed meal tolerance test (MMTT) via oral or G-tube feeding', 'Roux-en-Y Gastric Bypass']","['Plasma glucose, insulin, C-peptide, incretin responses, and indices of meal-stimulated insulin secretion and sensitivity', 'insulin and incretin secretion', 'Body weight, fat mass, fasting glucose and insulin, and circulating lipids', 'Incretin and Insulin Secretion', 'glucose response to feeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0150595', 'cui_str': 'Gastrostomy tube'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0242740', 'cui_str': 'Gastric Remnant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0150595', 'cui_str': 'Gastrostomy tube'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",15.0,0.0251465,"Oral feeding significantly enhanced insulin and incretin secretion after RYGB, which was entirely ablated by G-tube feeding.
","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH,USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH,USA.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Kullman', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH,USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH,USA.'}, {'ForeName': 'Wagner S', 'Initials': 'WS', 'LastName': 'Dantas', 'Affiliation': 'Integrated Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Baton Rouge, LA,USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Pergola', 'Affiliation': 'Integrated Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Baton Rouge, LA,USA.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Del Rincon', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH,USA.'}, {'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Brethauer', 'Affiliation': 'Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio,USA.'}, {'ForeName': 'Sangeeta R', 'Initials': 'SR', 'LastName': 'Kashyap', 'Affiliation': 'Department of Endocrinology and Metabolism, Cleveland Clinic, Cleveland, Ohio,USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Schauer', 'Affiliation': 'Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio,USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab255']
1143,33866849,Magnetic resonance imaging-based changes in vascular morphology and cerebral perfusion in subacute ischemic stroke.,"MRI-based vessel size imaging (VSI) allows for  in-vivo  assessment of cerebral microvasculature and perfusion. This exploratory analysis of vessel size (VS) and density (Q; both assessed via VSI) in the subacute phase of ischemic stroke involved sixty-two patients from the BAPTISe cohort ('Biomarkers And Perfusion--Training-Induced changes after Stroke') nested within a randomized controlled trial (intervention: 4-week training  vs.  relaxation). Relative VS, Q, cerebral blood volume (rCBV) and -flow (rCBF) were calculated for: ischemic lesion, perilesional tissue, and region corresponding to ischemic lesion on the contralateral side (mirrored lesion). Linear mixed-models detected significantly increased rVS and decreased rQ within the ischemic lesion compared to the mirrored lesion (coefficient[standard error]: 0.2[0.08] p = 0.03 and -1.0[0.3] p = 0.02, respectively); lesion rCBF and rCBV were also significantly reduced. Mixed-models did not identify time-to-MRI, nor training as modifying factors in terms of rVS or rQ up to two months post-stroke. Larger lesion VS was associated with larger lesion volumes (β 34, 95%CI 6.2-62; p = 0.02) and higher baseline NIHSS (β 3.0, 95%CI 0.49-5.3;p = 0.02), but was not predictive of six-month outcome. In summary, VSI can assess the cerebral microvasculature and tissue perfusion in the subacute phases of ischemic stroke, and may carry relevant prognostic value in terms of lesion volume and stroke severity.",2021,"Larger lesion VS was associated with larger lesion volumes (β 34, 95%CI 6.2-62; p = 0.02) and higher baseline NIHSS (β 3.0, 95%CI 0.49-5.3;p = 0.02), but was not predictive of six-month outcome.","[""subacute phase of ischemic stroke involved sixty-two patients from the BAPTISe cohort ('Biomarkers And Perfusion--Training-Induced changes after Stroke') nested within a randomized controlled trial (intervention"", 'subacute ischemic stroke']","['rCBF', 'Magnetic resonance imaging', 'MRI-based vessel size imaging (VSI']","['ischemic lesion, perilesional tissue, and region corresponding to ischemic lesion', 'cerebral microvasculature and tissue perfusion', 'Relative VS, Q, cerebral blood volume (rCBV) and -flow ', 'larger lesion volumes', 'rVS and decreased rQ', 'vascular morphology and cerebral perfusion', 'lesion rCBF and rCBV']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0243079', 'cui_str': 'microvasculature'}, {'cui': 'C0429877', 'cui_str': 'Tissue perfusion measure'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C4277714', 'cui_str': 'Cerebral Blood Volume'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",62.0,0.0464273,"Larger lesion VS was associated with larger lesion volumes (β 34, 95%CI 6.2-62; p = 0.02) and higher baseline NIHSS (β 3.0, 95%CI 0.49-5.3;p = 0.02), but was not predictive of six-month outcome.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kufner', 'Affiliation': 'Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Stroke Research Berlin, Berlin, Germany.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Khalil', 'Affiliation': 'Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Stroke Research Berlin, Berlin, Germany.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Galinovic', 'Affiliation': 'Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Stroke Research Berlin, Berlin, Germany.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kellner', 'Affiliation': 'Department of Radiology, Medical Physics, University Medical Center Freiburg, Freiburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Mekle', 'Affiliation': 'Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Stroke Research Berlin, Berlin, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Rackoll', 'Affiliation': 'Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Stroke Research Berlin, Berlin, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Boehm-Sturm', 'Affiliation': 'Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Stroke Research Berlin, Berlin, Germany.'}, {'ForeName': 'Jochen B', 'Initials': 'JB', 'LastName': 'Fiebach', 'Affiliation': 'Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Stroke Research Berlin, Berlin, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Flöel', 'Affiliation': 'Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Stroke Research Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ebinger', 'Affiliation': 'Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Stroke Research Berlin, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Stroke Research Berlin, Berlin, Germany.'}, {'ForeName': 'Alexander H', 'Initials': 'AH', 'LastName': 'Nave', 'Affiliation': 'Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Stroke Research Berlin, Berlin, Germany.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X211010071']
1144,33871602,Improved diet quality is associated with decreased concentrations of inflammatory markers in adults with uncontrolled asthma.,"BACKGROUND


Asthma has become one of the major public health challenges, and recent studies show promising clinical benefits of dietary interventions, such as the Dietary Approaches to Stop Hypertension (DASH) diet.
OBJECTIVE


The objective of this study was to examine whether changes in diet quality are associated with changes in inflammatory markers important in asthma pathophysiology.
METHODS


In this exploratory study in patients with poorly controlled asthma participating in a randomized controlled trial of a DASH intervention study, changes in concentrations of a broad panel of serum proteins (51-plex Luminex assay, Affymetrix) were determined, and their relation to diet quality (DASH score) assessed by combining data of both intervention and usual-care control groups. Second, the relation between the serum proteins, other biomarkers of inflammation and nutrition, and Asthma Control Questionnaire (ACQ) was assessed.
RESULTS


During the first 3 mo, diet quality (DASH scores) were inversely associated (P < 0.05, false discovery rate P < 0.09) with serum concentrations of a large number serum proteins, reflecting not only general proinflammatory markers such as IL-1β, transforming growth factor α (TGF-α), and IL-6 (r = -0.31 to -0.39) but also a number of proteins associated with asthmatic conditions, specifically several T-helper (Th) 2 (Th2; r = -0.29 to -0.34) and Th17 (r = -0.4) associated cytokines and growth factors. Monokine induced by gamma/chemokine (C-X-C motif) ligand 9 (CXCL9) (MIG/CXCL9), a T-cell attractant induced by IFN-γ previously linked to asthma exacerbations, appeared to be the marker most consistently associated with DASH diet quality for the entire 6-mo study period (r = -0.40 and -0.30 for 0-3 and 3-6 mo, respectively, and standardized coefficient loadings -0.13 in the partial least squares analyses). Decreases in 19 serum protein concentrations were also correlated with improved asthma control during the 6-mo study period.
CONCLUSIONS


Our data in adult patients with poorly controlled asthma suggest that dietary changes, like the introduction of DASH, may have beneficial effects on reducing inflammatory status. This trial was registered at http://www.clinicaltrials.gov as NCT01725945.",2021,"During the first 3 mo, diet quality (DASH scores) were inversely associated (P < 0.05, false discovery rate P < 0.09) with serum concentrations of a large number serum proteins, reflecting not only general proinflammatory markers such as IL-1β, transforming growth factor α (TGF-α), and IL-6 (r = -0.31 to -0.39) but also a number of proteins associated with asthmatic conditions, specifically several T-helper (Th) 2 (Th2; r = -0.29 to -0.34) and Th17 (r = -0.4) associated cytokines and growth factors.","['adults with uncontrolled asthma', 'adult patients with poorly controlled asthma', 'patients with poorly controlled asthma participating']","['DASH intervention', 'Monokine induced by gamma/chemokine (C-X-C motif']","['serum proteins, other biomarkers of inflammation and nutrition, and Asthma Control Questionnaire (ACQ', 'general proinflammatory markers such as IL-1β, transforming growth factor α (TGF-α), and IL-6', '19 serum protein concentrations', 'concentrations of inflammatory markers', 'DASH diet quality', 'diet quality (DASH scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026484', 'cui_str': 'Monokine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0036825', 'cui_str': 'Serum protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0451734,"During the first 3 mo, diet quality (DASH scores) were inversely associated (P < 0.05, false discovery rate P < 0.09) with serum concentrations of a large number serum proteins, reflecting not only general proinflammatory markers such as IL-1β, transforming growth factor α (TGF-α), and IL-6 (r = -0.31 to -0.39) but also a number of proteins associated with asthmatic conditions, specifically several T-helper (Th) 2 (Th2; r = -0.29 to -0.34) and Th17 (r = -0.4) associated cytokines and growth factors.","[{'ForeName': 'Unni C', 'Initials': 'UC', 'LastName': 'Nygaard', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Division of Pulmonary and Critical Care Medicine and Division of Allergy, Immunology and Rheumatology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Division of Pulmonary and Critical Care Medicine and Division of Allergy, Immunology and Rheumatology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kinjal M', 'Initials': 'KM', 'LastName': 'Hew', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Division of Pulmonary and Critical Care Medicine and Division of Allergy, Immunology and Rheumatology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Peg', 'Initials': 'P', 'LastName': 'Strub', 'Affiliation': 'Department of Allergy, Asthma and Immunology, Kaiser Permanente San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, Chicago, IL, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab063']
1145,33905343,Frequency of Interruptions to Sitting Time: Benefits for Postprandial Metabolism in Type 2 Diabetes.,"OBJECTIVE


To determine whether interrupting sitting with brief bouts of simple resistance activities (SRAs) at different frequencies improves postprandial glucose, insulin, and triglycerides in adults with medication-controlled type 2 diabetes (T2D).
RESEARCH DESIGN AND METHODS


Participants ( n  = 23, 10 of whom were female, with mean ± SD age 62 ± 8 years and BMI 32.7 ± 3.5 kg · m -2 ) completed a three-armed randomized crossover trial (6- to 14-day washout): sitting uninterrupted for 7 h (SIT), sitting with 3-min SRAs (half squats, calf raises, gluteal contractions, and knee raises) every 30 min (SRA3), and sitting with 6-min SRAs every 60 min (SRA6). Net incremental areas under the curve (iAUC net ) for glucose, insulin, and triglycerides were compared between conditions.
RESULTS


Glucose and insulin 7-h iAUC net  were attenuated significantly during SRA6 (glucose 17.0 mmol · h · L -1 , 95% CI 12.5, 21.4; insulin 1,229 pmol · h · L -1 , 95% CI 982, 1,538) in comparison with SIT (glucose 21.4 mmol · h · L -1 , 95% CI 16.9, 25.8; insulin 1,411 pmol · h · L -1 , 95% CI 1,128, 1,767;  P  < 0.05) and in comparison with SRA3 (for glucose only) (22.1 mmol · h · L -1 , 95% CI 17.7, 26.6;  P  = 0.01) No significant differences in glucose or insulin iAUC net  were observed in comparison of SRA3 and SIT. There was no statistically significant effect of condition on triglyceride iAUC net .
CONCLUSIONS


In adults with medication-controlled T2D, interrupting prolonged sitting with 6-min SRAs every 60 min reduced postprandial glucose and insulin responses. Other frequencies of interruptions and potential longer-term benefits require examination to clarify clinical relevance.",2021,No significant differences in glucose or insulin iAUC net  were observed in comparison of SRA3 and SIT.,"['Type 2 Diabetes', 'Participants ( n  = 23, 10 of whom were female, with mean ± SD age 62 ± 8 years and BMI 32.7 ± 3.5 kg · m -2 ) completed a three-armed randomized crossover trial ', 'adults with medication-controlled type 2 diabetes (T2D']","['6- to 14-day washout): sitting uninterrupted for 7 h (SIT), sitting with 3-min SRAs', 'sitting with brief bouts of simple resistance activities (SRAs']","['postprandial glucose and insulin responses', 'postprandial glucose, insulin, and triglycerides', 'glucose or insulin iAUC net', 'Net incremental areas under the curve (iAUC net ) for glucose, insulin, and triglycerides', 'triglyceride iAUC net ', 'iAUC net']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.110291,No significant differences in glucose or insulin iAUC net  were observed in comparison of SRA3 and SIT.,"[{'ForeName': 'Ashleigh R', 'Initials': 'AR', 'LastName': 'Homer', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia ashleigh.homer@baker.edu.au.'}, {'ForeName': 'Frances C', 'Initials': 'FC', 'LastName': 'Taylor', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Paddy C', 'Initials': 'PC', 'LastName': 'Dempsey', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wheeler', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Parneet', 'Initials': 'P', 'LastName': 'Sethi', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Melanie K', 'Initials': 'MK', 'LastName': 'Townsend', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Grace', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Sport Science, Exercise and Health, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Neale D', 'Initials': 'ND', 'LastName': 'Cohen', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Robyn N', 'Initials': 'RN', 'LastName': 'Larsen', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Bronwyn A', 'Initials': 'BA', 'LastName': 'Kingwell', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Owen', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}]",Diabetes care,['10.2337/dc20-1410']
1146,33908182,Comparison of metabolic effects of the progestational androgens dimethandrolone undecanoate and 11β-MNTDC in healthy men.,"BACKGROUND


Dimethandrolone (DMA) and 11β-methyl-19-nortestosterone (11β-MNT) are two novel compounds with both androgenic and progestational activity that are under investigation as potential male hormonal contraceptives. Their metabolic effects have never been compared in men.
OBJECTIVE


Assess for changes in insulin sensitivity and adiponectin and compare the metabolic effects of these two novel androgens.
MATERIALS/METHODS


In two clinical trials of DMA undecanoate (DMAU) and 11β-MNT dodecylcarbonate (11β-MNTDC), oral prodrugs of DMA and 11β-MNT, healthy men received drug, or placebo for 28 days. Insulin and adiponectin assays were performed on stored samples. Mixed model analyses were performed to compare the effects of the two drugs. Student's t test, or the non-parametric Kruskal-Wallis test as appropriate, was used to evaluate for an effect of active drug versus placebo.
RESULTS


Class effects were seen, with decrease in HDL-C and SHBG, and increase in weight and hematocrit, with no statistically significant differences between the two compounds. No changes in fasting glucose, fasting insulin, or HOMA-IR were seen with either compound. There was a slight decrease in adiponectin with DMAU that was not seen with 11β-MNTDC. An increase in LDL-C was seen with 11β-MNTDC but not with DMAU.
DISCUSSION


There were no significant changes in insulin resistance after 28 days of oral administration of these novel androgens despite a mild increase in weight. There may be subtle differences in their metabolic impacts that should be explored in future studies.
CONCLUSION


Changes in metabolic parameters should be carefully monitored when investigating androgenic compounds.",2021,There were no significant changes in insulin resistance after 28 days of oral administration of these novel androgens despite a mild increase in weight.,['Healthy Men'],"['Dimethandrolone (DMA) and 11β-methyl-19-nortestosterone (11β-MNT', 'placebo', 'DMA undecanoate (DMAU) and 11β-MNT dodecylcarbonate (11β-MNTDC), oral prodrugs of DMA and 11β-MNT', 'Progestational Androgens Dimethandrolone Undecanoate and 11β-MNTDC']","['weight and hematocrit', 'Insulin and adiponectin assays', 'fasting glucose, fasting insulin, or HOMA-IR', 'HDL-C and SHBG', 'adiponectin with DMAU', 'insulin resistance', 'weight', 'LDL-C']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1569975', 'cui_str': '7alpha,11beta-dimethyl-19-nortestosterone'}, {'cui': 'C0027368', 'cui_str': 'Nandrolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2974168', 'cui_str': 'dimethandrolone-undecanoate'}, {'cui': 'C0013013', 'cui_str': 'Commonwealth of Dominica'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033262', 'cui_str': 'Drug Precursors'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0013013', 'cui_str': 'Commonwealth of Dominica'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",,0.055222,There were no significant changes in insulin resistance after 28 days of oral administration of these novel androgens despite a mild increase in weight.,"[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Yuen', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Arthi', 'Initials': 'A', 'LastName': 'Thirumalai', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Fernando', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Youngju', 'Initials': 'Y', 'LastName': 'Pak', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hull', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Bross', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Long', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Page', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.'}]",Andrology,['10.1111/andr.13025']
1147,33904391,Effect of mandibular advancement device on plasticity in corticomotor control of tongue and jaw muscles.,"STUDY OBJECTIVES


This study aims to investigate whether the use of a mandibular advancement device (MAD) is associated with neuroplasticity in corticomotor control of tongue and jaw muscles.
METHODS


Eighteen healthy individuals participated in a randomized crossover study with 3 conditions for 2 weeks each: baseline, wearing an oral appliance (sham MAD), or MAD during sleep. The custom-made MAD was constructed by positioning the mandible to 50% of its maximal protrusion limit. Transcranial magnetic stimulation was applied to elicit motor-evoked potentials (MEPs). The MEPs were assessed by constructing stimulus-response curves at 4 stimulus intensities: 90%, 100%, 120%, and 160% of the motor threshold from the right tongue and right masseter and the first dorsal interosseous muscles (control) at baseline, after the first and the second intervention.
RESULTS


There was a significant effect of condition and stimulus intensity both on the tongue and on masseter MEPs ( P  < .01). Tongue and masseter MEPs were significantly higher at 120% and 160% after the MAD compared with the oral appliance ( P  < .05). There were no effects of condition on first dorsal interosseous muscle MEPs ( P  = .855).
CONCLUSIONS


The finding suggests that MAD induces neuroplasticity in the corticomotor pathway of the tongue and jaw muscles associated with the new jaw position. Further investigations are required in patients with obstructive sleep apnea to see whether this cortical neuroplasticity may contribute or perhaps predict treatment effects with MADs in obstructive sleep apnea.
CITATION


Matsuzaki S, Shimada A, Tanaka J, et al. Effect of mandibular advancement device on plasticity in corticomotor control of tongue and jaw muscles.  J Clin Sleep Med . 2021;17(9):1805-1813.",2021,There was a significant effect of condition and stimulus intensity both on the tongue and as well as on masseter MEPs (P < 0.01).,"['corticomotor control of tongue and jaw muscles', 'Eighteen healthy individuals participated', 'patients with obstructive sleep apnea (OSA']","['baseline, wearing an oral appliance (OA: sham MAD) or MAD', 'mandibular advancement device', 'mandibular advancement device (MAD', 'Transcranial magnetic stimulation (TMS', 'MAD']","['Tongue and masseter MEPs', 'condition and stimulus intensity', 'FDI MEPs']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C2091299', 'cui_str': 'Mandibular Advancement Devices'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",18.0,0.0377025,There was a significant effect of condition and stimulus intensity both on the tongue and as well as on masseter MEPs (P < 0.01).,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Matsuzaki', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Shimada', 'Affiliation': 'Department of Geriatric Dentistry, Osaka Dental University, Osaka, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Tanaka', 'Affiliation': 'Department of Fixed Prosthodontics and Occlusion, Osaka Dental University, Osaka, Japan.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Kothari', 'Affiliation': 'Hammel Neurorehabilitation and University Research Clinic, Department of Clinic Medicine, Aarhus University, Hammel, Aarhus, Denmark.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Castrillon', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Iida', 'Affiliation': 'Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo, Chiba, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Faculty of Health, Aarhus University, Aarhus, Denmark.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9284']
1148,33910364,"Additional, Mechanized Upper Limb Self-Rehabilitation in Patients With Subacute Stroke: The REM-AVC Randomized Trial.",[Figure: see text].,2021,There was no between-group difference in mean change in Fugl-Meyer Assessment score following the intervention: 13.3 (9.0) in the Exo group and 11.8 (8.8) in the control group ( P =0.22).,"['Mean age (SD), 58.3 (13.6) years', 'patients with stroke', 'Patients aged 18 to 80 years, 3 weeks to 3 months poststroke with a Fugl-Meyer Assessment score of 10 to 40 points', 'Patients With Subacute Stroke', 'Two hundred fifteen participants']","['mechanized device with control self-exercises', 'Mechanized Upper Limb Self-Rehabilitation', 'stretching plus basic active exercises', 'games-based exercises using a gravity-supported mechanical exoskeleton (Armeo Spring', 'self-rehabilitation']","['change in upper extremity Fugl-Meyer Assessment score', 'mean baseline Fugl-Meyer Assessment score', 'cost utility', 'mean change in Fugl-Meyer Assessment score', 'mean time poststroke']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0419117', 'cui_str': 'Active exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",215.0,0.0449091,There was no between-group difference in mean change in Fugl-Meyer Assessment score following the intervention: 13.3 (9.0) in the Exo group and 11.8 (8.8) in the control group ( P =0.22).,"[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Rémy-Néris', 'Affiliation': 'Physical and Rehabilitation Medicine Department (O.R.-N., B.M., É.P.), Brest University Hospital, France.'}, {'ForeName': 'Anaïs', 'Initials': 'A', 'LastName': 'Le Jeannic', 'Affiliation': 'Health Economics Clinical Research Unit (URC Eco), APHP, Paris, France (A.L.J., I.D.-Z.).'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Dion', 'Affiliation': 'INSERM, CIC 1412 (A.D., E.N.), Brest University Hospital, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Médée', 'Affiliation': 'Physical and Rehabilitation Medicine Department (O.R.-N., B.M., É.P.), Brest University Hospital, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Nowak', 'Affiliation': 'INSERM, CIC 1412 (A.D., E.N.), Brest University Hospital, France.'}, {'ForeName': 'Élodie', 'Initials': 'É', 'LastName': 'Poiroux', 'Affiliation': 'Physical and Rehabilitation Medicine Department (O.R.-N., B.M., É.P.), Brest University Hospital, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': 'Health Economics Clinical Research Unit (URC Eco), APHP, Paris, France (A.L.J., I.D.-Z.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.032545']
1149,33867499,Musculoskeletal Responses to Exercise Plus Nutrition in Men with Prostate Cancer on Androgen Deprivation: A 12-Month RCT.,"PURPOSE


Androgen deprivation therapy (ADT) for prostate cancer has multiple adverse effects on musculoskeletal health. This 12-month randomized controlled trial aimed to assess the effects of multicomponent exercise training combined with whey protein, calcium and vitamin D supplementation on bone mineral density (BMD), structure and strength, body composition, muscle strength, and physical function in ADT-treated men.
METHODS


Seventy ADT-treated men were randomized to exercise plus supplementation (Ex + Suppl; n = 34) or usual care (control; n = 36). Ex + Suppl involved thrice weekly progressive resistance training plus weight-bearing impact exercise with daily multinutrient supplementation. Primary outcomes were DXA hip and spine areal BMD. Secondary outcomes included the following: tibia and radius pQCT volumetric BMD, bone structure and strength, DXA body composition, pQCT muscle and fat cross-sectional area and muscle density, and muscle strength and physical function.
RESULTS


Sixty men (86%) completed the study. Mean exercise and supplement adherence were 56% and 77%, respectively. There were no effects of the intervention on bone or body composition outcomes. Ex + Suppl improved leg muscle strength (net difference, (95% confidence interval, or CI), 14.5% (-0.2 to 29.2); P = 0.007) and dynamic mobility (four-square-step test time, -9.3% (-17.3 to -1.3), P = 0.014) relative to controls. Per-protocol analysis of adherent participants (≥66% exercise, ≥80% supplement) showed Ex + Suppl preserved femoral neck aBMD (1.9% (0.1 to 3.8), P = 0.026) and improved total body lean mass (1.0 kg (-0.23 to 2.22), P = 0.044) relative to controls.
CONCLUSIONS


Exercise training combined with multinutrient supplementation had a limited effect on ameliorating the adverse musculoskeletal consequences of ADT, likely related to the modest intervention adherence.",2021,"Ex+Suppl improved leg muscle strength (net difference [95% CI] 14.5% [-0.2, 29.2], P=0.007) and dynamic mobility (four-square-step test time, -9.3% [-17.3, -1.3], P=0.014) relative to controls.","['prostate cancer (PCa', 'ADT-treated men', 'Men with Prostate Cancer on Androgen Deprivation', 'Seventy ADT-treated men', 'Sixty men (86%) completed the study']","['Exercise training combined with multi-nutrient supplementation', 'Androgen deprivation therapy (ADT', 'exercise plus supplementation (Ex+Suppl; n=34) or usual care', 'Exercise plus Nutrition', 'multi-component exercise training combined with whey protein, calcium and vitamin D supplementation', 'Ex+Suppl involved thrice weekly progressive resistance training plus weight-bearing impact exercise with daily multi-nutrient supplementation']","['DXA hip and spine areal BMD', 'total body lean mass', 'Mean exercise and supplement adherence', 'leg muscle strength', 'bone or body composition outcomes', 'Ex+Suppl preserved femoral neck aBMD', 'bone mineral density (BMD), structure and strength, body composition, muscle strength and physical function', 'tibia and radius pQCT volumetric BMD, bone structure and strength; DXA body composition; pQCT muscle and fat cross-sectional area and muscle density; muscle strength and physical function', 'dynamic mobility']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.0280392,"Ex+Suppl improved leg muscle strength (net difference [95% CI] 14.5% [-0.2, 29.2], P=0.007) and dynamic mobility (four-square-step test time, -9.3% [-17.3, -1.3], P=0.014) relative to controls.","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Dalla Via', 'Affiliation': ''}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Owen', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, AUSTRALIA.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, AUSTRALIA.'}, {'ForeName': 'Niamh L', 'Initials': 'NL', 'LastName': 'Mundell', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, AUSTRALIA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Livingston', 'Affiliation': 'Deakin University, Faculty of Health, Geelong, Victoria, AUSTRALIA.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Rantalainen', 'Affiliation': ''}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Foulkes', 'Affiliation': ''}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Millar', 'Affiliation': 'Radiation Oncology, Alfred Health, Melbourne, Victoria, AUSTRALIA.'}, {'ForeName': 'Declan G', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Steve F', 'Initials': 'SF', 'LastName': 'Fraser', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002682']
1150,33867498,The Effect of Aerobic Training and Increasing Nonexercise Physical Activity on Cardiometabolic Risk Factors.,"PURPOSE


Epidemiological studies suggest that sedentary behavior is an independent risk factor for cardiovascular mortality independent of meeting physical activity guidelines. However, limited evidence of this relationship is available from prospective interventions. The purpose of the present study is to evaluate the combined effect of aerobic training and increasing nonexercise physical activity on body composition and cardiometabolic risk factors.
METHODS


Obese adults (N = 45) were randomized to 6 months of aerobic training (AERO), aerobic training and increasing nonexercise physical activity (~3000 steps above baseline levels; AERO-PA), or a control (CON) group. The AERO and AERO-PA groups performed supervised aerobic training (3-4 times per week). The AERO-PA group wore Fitbit One accelerometers and received behavioral coaching to increase nonexercise physical activity.
RESULTS


There was a larger increase in fitness in the AERO-PA group (0.27 L·min-1; confidence interval (CI), 0.16 to 0.40 L·min-1) compared with the AERO group (0.09 L·min-1; CI, -0.04 to 0.22 L·min-1) and the CON group (0.01; CI, -0.11 to 0.12 L·min-1). Although significant findings were not observed in the entire study sample, when the analysis was restricted to participants compliant to the intervention (n = 33), we observed significant reductions in waist circumference, percent weight loss, body fat, 2-h glucose, and 2-h insulin in comparison to the CON group (P < 0.05), but not the AERO group. Furthermore, linear regression models showed that change in steps was associated with 21% and 26% of the variation in percent weight loss and percent fat loss, respectively.
CONCLUSIONS


Increasing nonexercise physical activity with aerobic training may represent a viable strategy to augment the fitness response in comparison to aerobic training alone and has promise for other health indicators.",2021,"There was a larger increase in fitness in the AERO-PA group (0.27 L/min, 0.16 to 0.40) compared to the AERO group (0.09 L/min, CI: -0.04 to 0.22) and the CON (0.01, CI: -0.11 to 0.12) groups.",['Obese adults (N=45'],"['aerobic training and increasing non-exercise physical activity', 'aerobic training (AERO), aerobic training and increasing non-exercise physical activity (~3,000 steps above baseline levels) (AERO-PA), or a control group (CON', 'Aerobic Training', 'supervised aerobic training', 'aerobic training', 'behavioral coaching']","['percent weight loss and percent fat loss', 'waist circumference, percent weight loss, body fat, 2-hr glucose and 2-hr insulin', 'fitness', 'Cardiometabolic Risk Factors']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",45.0,0.00418054,"There was a larger increase in fitness in the AERO-PA group (0.27 L/min, 0.16 to 0.40) compared to the AERO group (0.09 L/min, CI: -0.04 to 0.22) and the CON (0.01, CI: -0.11 to 0.12) groups.","[{'ForeName': 'Damon L', 'Initials': 'DL', 'LastName': 'Swift', 'Affiliation': ''}, {'ForeName': 'Tyara R', 'Initials': 'TR', 'LastName': 'Nevels', 'Affiliation': ''}, {'ForeName': 'Chelsey A', 'Initials': 'CA', 'LastName': 'Solar', 'Affiliation': ''}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Brophy', 'Affiliation': 'East Carolina Diabetes and Obesity Institute, East Carolina University, Greenville, NC.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'McGee', 'Affiliation': ''}, {'ForeName': 'Savanna B', 'Initials': 'SB', 'LastName': 'Brewer', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'East Carolina Diabetes and Obesity Institute, East Carolina University, Greenville, NC.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Houmard', 'Affiliation': ''}, {'ForeName': 'Lesley D', 'Initials': 'LD', 'LastName': 'Lutes', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002675']
1151,33867497,Skeletal Muscle Adaptive Responses to Different Types of Short-Term Exercise Training and Detraining in Middle-Age Men.,"INTRODUCTION


Whether short-term, single-mode exercise training can improve physical fitness before a period of reduced physical activity (e.g., postsurgery recovery) is not well characterized in clinical populations or middle-age adults. We investigated skeletal muscle adaptive responses after endurance exercise training (ENT), high-intensity interval training (HIIT), or resistance exercise training (RET), and a subsequent period of detraining, in sedentary, middle-age men.
METHODS


Thirty-five sedentary men (39 ± 3 yr) were randomized to parallel groups and undertook 6 wk of either ENT (n = 12), HIIT (n = 12), or RET (n = 11) followed by 2.5 wk of detraining. Skeletal muscle fiber characteristics, body composition, muscle thickness, muscle strength, aerobic capacity, resting energy expenditure, and glucose homeostasis were assessed at baseline, and after exercise training and detraining.
RESULTS


Lean mass increased after RET and HIIT (+3.2% ± 1.6% and +1.6% ± 2.1%, P < 0.05). Muscle strength (sum of leg press, leg extension, and bench press one-repetition maximums) increased after all training interventions (RET, +25% ± 5%; HIIT, +10% ± 5%; ENT, +7% ± 7%; P < 0.05). Aerobic capacity increased only after HIIT and ENT (+14% ± 7% and +11% ± 11%, P < 0.05). Type I and II muscle fiber size increased for all groups after training (main effect of time, P < 0.05). After a period of detraining, the gains in lean mass and maximal muscle strength were maintained in the RET and HIIT groups, but maximal aerobic capacity declined below posttraining levels in HIIT and ENT (P < 0.05).
CONCLUSIONS


Six weeks of HIIT induced widespread adaptations before detraining in middle-age men. Exercise training-induced increases in aerobic capacity declined during 2.5 wk of detraining, but gains in lean mass and muscle strength were maintained.",2021,"Type I and II muscle fiber size increased for all groups post-training (main effect of time, P<0.05).","['Middle-Age Men', 'Thirty-five sedentary, males (39±3 yr', 'middle-age men', 'sedentary, middle-age men']","['Short-Term Exercise Training and Detraining', 'single-mode exercise training', 'RET', 'Exercise training', 'ENT', 'endurance exercise training (ENT), high-intensity interval training (HIIT) or resistance exercise training (RET']","['maximal aerobic capacity', 'Muscle strength (sum of leg press, leg extension and bench press 1RMs', 'lean mass and maximal muscle strength', 'Skeletal muscle fiber characteristics, body composition, muscle thickness, muscle strength, aerobic capacity, resting energy expenditure and glucose homeostasis', 'aerobic capacity', 'Aerobic capacity', 'Lean mass']","[{'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1704336', 'cui_str': 'Skeletal muscle fiber'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}]",35.0,0.0100301,"Type I and II muscle fiber size increased for all groups post-training (main effect of time, P<0.05).","[{'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Callahan', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, AUSTRALIA.'}, {'ForeName': 'Evelyn B', 'Initials': 'EB', 'LastName': 'Parr', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, AUSTRALIA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Snijders', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the NETHERLANDS.'}, {'ForeName': 'Miguel S', 'Initials': 'MS', 'LastName': 'Conceição', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, BRAZIL.'}, {'ForeName': 'Bridget E', 'Initials': 'BE', 'LastName': 'Radford', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, AUSTRALIA.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Timmins', 'Affiliation': ''}, {'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Devlin', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, La Trobe University, Melbourne, AUSTRALIA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hawley', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, AUSTRALIA.'}, {'ForeName': 'Donny M', 'Initials': 'DM', 'LastName': 'Camera', 'Affiliation': 'Department of Health and Medical Sciences, Swinburne University of Technology, Melbourne, Victoria, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002684']
1152,33867496,High-Intensity Interval Training in Patients with Pulmonary Embolism: A Randomized Controlled Trial.,"PURPOSE


High-intensity interval training (HIIT) appears to be safe and effective in cardiovascular diseases. However, there is a paucity of data on the effect of HIIT for patients with acute pulmonary embolism (PE). The present randomized controlled trial (RCT) therefore examined the efficiency and safety of HIIT in patients with acute PE.
METHODS


In single-center parallel open-label RCT, 24 patients (5 women) discharged recently with a diagnosis of intermediate-high-risk acute PE were randomized (1:1) to supervised HIIT (n = 12) or control (n = 12) group. The primary outcomes were exercise capacity evaluated in terms of the estimated maximal oxygen uptake (eV˙O2max), lung function (forced expiratory volume in 1 s [FEV1]), right ventricular (RV) function (RV/left ventricular diameter [LV] ratio), and health-related quality of life (HRQoL). Safety was the secondary outcome.
RESULTS


Eight weeks of HIIT improved eV˙O2max (+65%, P < 0.001), FEV1 (%) (+17%, P = 0.031), and RV/LV ratio diameter (-27%, P = 0.005), as well as HRQoL. All patients in the HIIT group tolerated exercise training without serious adverse events. The control group did not improve (P > 0.05) eV˙O2max, RV/LV ratio diameter, or HRQoL; however, FEV1 (%) was slightly reduced (-6%, P = 0.030).
CONCLUSIONS


The present RCT of a tailored center-based HIIT intervention provides preliminary evidence that this intervention could improve exercise capacity, lung function, RV function, and HRQoL without serious adverse events, which could provide marked clinical benefits after PE. Further larger multicenter randomized controlled studies are needed to confirm these promising findings.",2021,"RESULTS


8-weeks of HIIT improved eVO2max (+65%, p < 0.001),","['patients with acute pulmonary embolism (PE', 'In single-center parallel open-label RCT, 24 patients (5 women) discharged recently with a diagnosis of intermediate-high risk acute PE were randomized (1:1) to supervised HIIT (n = 12) or control (n = 12) group', 'patients with acute PE', 'Patients with Pulmonary Embolism']","['High-Intensity Interval Training', 'FEV1 (%) ', 'High-intensity interval training (HIIT', 'HIIT group tolerated exercise training']","['eVO2max', 'eVO2max, RV/LV ratio diameter, or HRQoL; however, FEV1', 'exercise capacity, lung function, RV function, and HRQoL without serious adverse events', 'RV/LV ratio diameter', 'exercise capacity evaluated in terms of the estimated maximal oxygen uptake (eVO2max), lung function (forced expiratory volume in 1 second, FEV1), right ventricular (RV) function, (RV/left ventricle diameter (LV) ratio) and health related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0080311', 'cui_str': 'Right ventricular function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}]",,0.104807,"RESULTS


8-weeks of HIIT improved eVO2max (+65%, p < 0.001),","[{'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Ghram', 'Affiliation': ''}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Jenab', 'Affiliation': 'Department of Interventional Cardiology, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, IRAN.'}, {'ForeName': 'Rahman', 'Initials': 'R', 'LastName': 'Soori', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, IRAN.'}, {'ForeName': 'Siroos', 'Initials': 'S', 'LastName': 'Choobineh', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, IRAN.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hosseinsabet', 'Affiliation': 'Department of Interventional Cardiology, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, IRAN.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Niyazi', 'Affiliation': 'Department of Cardiac Rehabilitation, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, IRAN.'}, {'ForeName': 'Shapoor', 'Initials': 'S', 'LastName': 'Shirani', 'Affiliation': 'Head of Imaging Department, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, IRAN.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Shafiee', 'Affiliation': 'Department of Cardiovascular Research, Tehran Heart Center, Cardiovascular Disease Research Institute, Tehran University of Medical Sciences, Tehran, IRAN.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Cardiovascular Research, Tehran Heart Center, Cardiovascular Disease Research Institute, Tehran University of Medical Sciences, Tehran, IRAN.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Lavie', 'Affiliation': 'Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute, Ochsner Clinical School-the University of Queensland School of Medicine, New Orleans, LA.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Wisløff', 'Affiliation': 'Cardiac Exercise Research Group at the Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, NORWAY.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002680']
1153,33905482,"Local Hyperthermia at 44°C Is Effective in Clearing Cervical High-Risk Human Papillomaviruses: A Proof-of-Concept, Randomized Controlled Clinical Trial.","BACKGROUND


Persistent infection by high-risk human papillomavirus (HPV) is the leading cause of cervical intraepithelial neoplasia and cervical carcinoma. Local hyperthermia at 44ºC has been proven efficacious to clear cutaneous or anogenital warts caused by HPV infection. This study aims to assess the effect of hyperthermia at 44ºC on the clearance of high-risk HPV.
METHODS


A randomized, patient-blind, sham treatment-controlled trial was conducted in 4 medical centers. We enrolled patients with positive high-risk HPVs and normal or insignificant cytological findings (negative/atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesion). Participants were randomly assigned (1:1) to receive either hyperthermia at 44ºC or 37ºC, for 30 minutes in each session. Patients in both groups received treatment once a day for 3 consecutive days, plus 2 more sessions 10 ± 3 days later. The primary outcome was clearance rate of HPV 3 months after treatment.
RESULTS


After a 3-month follow-up, hyperthermia treatment at 44ºC and 37ºC achieved HPV clearance rates of 85.19% (23/27) and 50% (13/26), respectively (P = .014). There was no significant difference of treatment response between patients with single and multiple type of HPV by 44ºC hyperthermia treatment. There were no significant adverse events recorded during the treatment period in both groups.
CONCLUSIONS


Local hyperthermia at 44ºC safely and significantly aids in clearing cervical high-risk HPVs, the effect of which helps halt the progression of cervical transformation and transmission of the virus.
CLINICAL TRIALS REGISTRATION


NCT03436251.",2021,There was no significant difference of treatment response between patients with single and multiple type of HPV by 44 ºC hyperthermia treatment.,"['enrolled patients with positive high-risk HPVs and normal or insignificant cytological findings (Negative/ASCUS/LSIL', 'cervical intraepithelial neoplasia and cervical carcinoma']",['hyperthermia at 44 ºC or 37 ºC'],"['adverse events', 'HPV clearance rates', 'clearance rate of HPV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0521184', 'cui_str': 'Atypical squamous cells of undetermined significance'}, {'cui': 'C1302773', 'cui_str': 'Squamous intraepithelial neoplasia, low grade'}, {'cui': 'C0206708', 'cui_str': 'Cervical intraepithelial neoplasia'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",,0.281159,There was no significant difference of treatment response between patients with single and multiple type of HPV by 44 ºC hyperthermia treatment.,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'GCP Center, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huo', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Ruiqun', 'Initials': 'R', 'LastName': 'Qi', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Central Hospital Affiliated to Shenyang Medical College, Shenyang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Bai', 'Affiliation': ""Department of Obstetrics and Gynecology, Liaoning Province People's Republic of China, Shenyang, China.""}, {'ForeName': 'Kuiran', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynecology, Shengjing Hospital affiliated to China Medical University, Shenyang, China.'}, {'ForeName': 'Youlin', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Peking, China.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Piguet', 'Affiliation': ""Division of Dermatology, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Croitoru', 'Affiliation': 'Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Hong-Duo', 'Initials': 'HD', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Xing-Hua', 'Initials': 'XH', 'LastName': 'Gao', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University, Shenyang, China.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab369']
1154,33899783,The Benefit of a Couple-Based Intervention Among Women in Active Cancer Treatment on Sexual Concerns: A Quasi-Experimental Study.,"BACKGROUND


Sexuality-related problems are common in women with cancer, threatening their sexual well-being and intimate relationships. Evidence-based interventions addressing the full range of sexual concerns among women in active cancer treatment are scarce.
OBJECTIVE


The aim of this study was to evaluate the benefits of a novel couple-based intervention focusing on sexual concerns among women undergoing cancer treatment, including a subgroup of women with breast cancer. A secondary aim was to assess changes in illness intrusiveness in daily life.
METHODS


A quasi-experimental single-group pre-post follow-up design was used. The study was initially planned as a randomized controlled trial with waitlist control group receiving delayed intervention. However, substantial differences were observed in clinical and demographic variables between the treatment group and control group, resulting in using a single-group pre-post follow-up design. The intervention consists of 3 advanced nurse-led, face-to-face couple-based sessions supported by access to web-based information.
RESULTS


Women in active cancer treatment participated in the study (n = 60) together with their partners (n = 60). The main results showed significant differences between time points in the outcome measures for concerns related to the sexual adverse effects of cancer treatment (T1 vs T2, and T2 vs T3), sexual concerns related to the women's partners (T1 vs T2), and for concerns related to communication with healthcare providers about sexuality-related issues (T1 vs T2). No significant changes were found over time with respect to illness interference on the intimacy or instrumental subscales.
CONCLUSIONS


The results demonstrated that the approach of 3 couple-based therapeutic conversations is beneficial in reducing sexual concerns among women in active cancer treatment.
IMPLICATIONS FOR PRACTICE


Advanced nurse practitioners can develop and offer brief psychoeducational support that is helpful in reducing sexual concerns among women in active cancer treatment.",2021,"The main results showed significant differences between time points in the outcome measures for concerns related to the sexual adverse effects of cancer treatment (T1 vs T2, and T2 vs T3), sexual concerns related to the women's partners (T1 vs T2), and for concerns related to communication with healthcare providers about sexuality-related issues (T1 vs T2).","['Women in active cancer treatment participated in the study (n = 60) together with their partners (n = 60', 'women in active cancer treatment', 'women undergoing cancer treatment, including a subgroup of women with breast cancer', 'Advanced nurse practitioners', 'Women in Active Cancer Treatment on Sexual Concerns', 'women with cancer']","['waitlist control group receiving delayed intervention', 'novel couple-based intervention', 'advanced nurse-led, face-to-face couple-based sessions supported by access to web-based information', 'Couple-Based Intervention']","['sexual adverse effects of cancer treatment', 'sexual concerns', 'illness intrusiveness in daily life', 'intimacy or instrumental subscales']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}]",60.0,0.0882851,"The main results showed significant differences between time points in the outcome measures for concerns related to the sexual adverse effects of cancer treatment (T1 vs T2, and T2 vs T3), sexual concerns related to the women's partners (T1 vs T2), and for concerns related to communication with healthcare providers about sexuality-related issues (T1 vs T2).","[{'ForeName': 'Jona Ingibjorg', 'Initials': 'JI', 'LastName': 'Jonsdottir', 'Affiliation': 'Author Affiliations: Landspitali-The National University Hospital of Iceland (Ms Jonsdottir and Dr Svavarsdottir); and School of Health Sciences, Faculty of Nursing, University of Iceland (Ms Jonsdottir and Drs Vilhjalmsson and Svavarsdottir), Reykjavik.'}, {'ForeName': 'Runar', 'Initials': 'R', 'LastName': 'Vilhjalmsson', 'Affiliation': ''}, {'ForeName': 'Erla Kolbrun', 'Initials': 'EK', 'LastName': 'Svavarsdottir', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000949']
1155,33913373,A pilot study of thiamin and folic acid in hemodialysis patients with cognitive impairment.,"OBJECTIVE


This study aimed to explore the effectiveness of thiamin and folic acid supplementation on the improvement of the cognitive function in patients with maintenance hemodialysis.
METHOD


In the present study, we randomly assigned patients undergoing hemodialysis who had the Montreal Cognitive Assessment (MoCA) score lower than 26 to treatment group ( n  = 25, thiamin 90 mg/day combined with folic acid 30 mg/day) or control group ( n  = 25, nonintervention). All subjects were followed up for 96 weeks. The primary outcome was the improvement of the MoCA score. The secondary outcomes included homocysteine level, survival and safety.
RESULTS


Patients in treatment group had an increase of the MoCA score from 21.95 ± 3.81 at baseline to 25.68 ± 1.96 at week 96 ( p  < 0.001, primary outcome), as compared with the MoCA score from 20.69 ± 3.40 to 19.62 ± 3.58 in control group. Thiamin combined with folic acid treatment also resulted in lower level of serum homocysteine in treatment group compare with control group at week 96 ( p  < 0.05, secondary outcome). 3 patients and 9 patients died during follow-up period in treatment and control group respectively ( p  = 0.048). The proportion of adverse events in treatment group was significantly lower than that in control group.
CONCLUSION


Hemodialysis patients with cognitive impairment treated with thiamin and folic acid had a significant improvement in MoCA score.",2021,"Thiamin combined with folic acid treatment also resulted in lower level of serum homocysteine in treatment group compare with control group at week 96 ( p  < 0.05, secondary outcome).","['hemodialysis patients with cognitive impairment', 'Hemodialysis patients with cognitive impairment treated with', 'patients undergoing hemodialysis who had the Montreal Cognitive Assessment (MoCA) score lower than 26 to treatment group ( n \u2009=\u200925', 'patients with maintenance hemodialysis']","['thiamin and folic acid supplementation', 'thiamin 90\u2009mg/day combined with folic acid 30\u2009mg/day) or control group ( n \u2009=\u200925, nonintervention', 'Thiamin combined with folic acid', 'thiamin and folic acid']","['homocysteine level, survival and safety', 'lower level of serum homocysteine', 'MoCA score', 'proportion of adverse events', 'improvement of the MoCA score', 'cognitive function']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2242817', 'cui_str': 'Homocysteine measurement'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",3.0,0.0674055,"Thiamin combined with folic acid treatment also resulted in lower level of serum homocysteine in treatment group compare with control group at week 96 ( p  < 0.05, secondary outcome).","[{'ForeName': 'Renhua', 'Initials': 'R', 'LastName': 'Lu', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Miaolin', 'Initials': 'M', 'LastName': 'Che', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jianxiao', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Haifen', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Clinical Center for Investigation, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Mou', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}]",Renal failure,['10.1080/0886022X.2021.1914656']
1156,33904521,"Striatin genotype-based, mineralocorticoid receptor antagonist-driven clinical trial: study rationale and design.","OBJECTIVES


In human studies and genetically altered mouse studies, variants in the striatin gene (STRN) are associated with increased blood pressure (BP) and aldosterone on a liberal salt diet. This clinical trial is based on the presumed mechanism for striatin-associated HTN - increased aldosterone. It is designed to determine if participants with the STRN risk alleles will have a greater BP reduction on a liberal salt diet with a specific, mechanism-based therapy - a mineralocorticoid receptor antagonist, eplerenone - as compared with a nonspecific anti-hypertensive therapy - amlodipine.
METHODS


One hundred five hypertensive adults with the STRN risk alleles (SNP rs2540923 carriers or rs888083 homozygotes) will be enrolled in a 12-week, double-blind, dose-escalation, clinical trial. After a minimum 2-week washout period and baseline assessment of BP on a liberal salt diet, participants will be randomized to either daily eplerenone or amlodipine. Participants will take daily at-home BP recordings as a safety check. After 4 and 8 weeks of drug therapy, BP will be measured by the study team and medication will be increased, if needed, to achieve a participant goal BP of <140/90 mmHg.Anticipated results We anticipate that STRN risk allele carriers will demonstrate a greater reduction in BP with eplerenone and will require a lower dose of eplerenone to reach goal BP as compared with amlodipine.
CONCLUSION


This is a proof-of-concept clinical trial. Positive results support the feasibility of performing genetically-defined, mechanistically-driven trials in HTN. Clinically, it would suggest that genetic biomarkers can identify individuals highly responsive to specific treatment.",2021,"In human studies and genetically altered mouse studies, variants in the striatin gene (STRN) are associated with increased blood pressure (BP) and aldosterone on a liberal salt diet.","['One hundred five hypertensive adults with the STRN risk alleles (SNP rs2540923 carriers or rs888083 homozygotes', 'participants with the STRN risk alleles']","['eplerenone or amlodipine', 'amlodipine']",['blood pressure (BP) and aldosterone'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}]","[{'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}]",105.0,0.265363,"In human studies and genetically altered mouse studies, variants in the striatin gene (STRN) are associated with increased blood pressure (BP) and aldosterone on a liberal salt diet.","[{'ForeName': 'Isabella B', 'Initials': 'IB', 'LastName': 'Stone', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Jessica A E M', 'Initials': 'JAEM', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Koefoed', 'Affiliation': ''}, {'ForeName': 'Ezra S', 'Initials': 'ES', 'LastName': 'Hornik', 'Affiliation': ''}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Gail K', 'Initials': 'GK', 'LastName': 'Adler', 'Affiliation': ''}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Williams', 'Affiliation': ''}]",Pharmacogenetics and genomics,['10.1097/FPC.0000000000000425']
1157,33909896,Effect of Exercise Involving Standing Weight Shifting to the Nonparetic Side on an Inclined Surface in the Early Phase After a Stroke: A Randomized Controlled Trial.,"OBJECTIVE


This study aimed to clarify whether an exercise involving weight shifting to the nonparetic side while standing on an inclined surface improves standing balance in the early phase after stroke.
METHODS


This assessor-blinded, randomized controlled trial included people undergoing inpatient rehabilitation at a university hospital. Participants (N = 52) with hemiparesis caused by a stroke were randomly assigned to an experimental group (n = 26) or control group (n = 26). Participants performed a weight-shifting exercise to the nonparetic side using a goal-directed reaching strategy while standing on an inclined surface that was elevated 5 degrees to the nonparetic side in the experimental group or a flat surface in the control group. The reaching exercise was conducted 30 times per day for 5 days. Primary outcome was the Berg Balance Scale. Secondary outcomes were the posturographic examination (static standing and lateral weight shifting to the nonparetic and paretic sides), Trunk Control Test, Trunk Impairment Scale, Functional Ambulation Category, and Functional Independent Measure motor item scores.
RESULTS


Through intention-to-treat analysis, no significant intervention effects were observed between groups on the Berg Balance Scale. A significant intervention effect was observed, however, with the experimental group on the lateral weight shifting to the nonparetic side in the mean percentage bodyweight values and center-of-pressure moving distance and to the paretic side in center-of-pressure moving distance and Functional Ambulation Category. There were no significant interaction effects concerning other outcomes.
CONCLUSION


These results suggest that standing reaching exercises to the nonparetic side while standing on an inclined surface could improve lateral weight-shifting capacity and gait ability in participants in the early poststroke phase.
IMPACT


This intervention should be incorporated into standard treatment programs focusing on the paretic side during early stroke rehabilitation.",2021,"A significant intervention effect was observed, however, with the experimental group on the lateral weight shifting to the nonparetic side in the mean percentage body-weight values and center-of-pressure moving distance and to the paretic side in center-of-pressure moving distance and Functional Ambulation Category.","['Participants (n\u2009=\u200952) with hemiparesis caused by a stroke', 'people undergoing inpatient rehabilitation at a university hospital']","['standing reaching exercises', 'weight-shifting exercise to the nonparetic side using a goal-directed reaching strategy while standing']","['posturographic examination (static standing and lateral weight shifting to the nonparetic and paretic sides), Trunk Control Test, Trunk Impairment Scale, Functional Ambulation Category, and Functional Independent Measure motor item scores', 'Berg Balance Scale (BBS', 'lateral weight-shifting capacity and gait ability', 'standing balance']","[{'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",52.0,0.0766808,"A significant intervention effect was observed, however, with the experimental group on the lateral weight shifting to the nonparetic side in the mean percentage body-weight values and center-of-pressure moving distance and to the paretic side in center-of-pressure moving distance and Functional Ambulation Category.","[{'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Department of Rehabilitation, Saitama Medical University International Medical Center, Yamane, Hidaka, Saitama, Japan.'}, {'ForeName': 'Kazu', 'Initials': 'K', 'LastName': 'Amimoto', 'Affiliation': 'Department of Physical Therapy, Tokyo Metropolitan University, Higashiogu, Arakawa-ku, Tokyo, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Chiba', 'Affiliation': 'Department of Rehabilitation, Saitama Medical University International Medical Center, Yamane, Hidaka, Saitama, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sekine', 'Affiliation': 'Department of Rehabilitation, Saitama Medical University International Medical Center, Yamane, Hidaka, Saitama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Fukata', 'Affiliation': 'Department of Rehabilitation, Saitama Medical University International Medical Center, Yamane, Hidaka, Saitama, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Fujino', 'Affiliation': 'Department of Physical Therapy, Juntendo University, Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Rehabilitation, Saitama Medical University International Medical Center, Yamane, Hidaka, Saitama, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Makita', 'Affiliation': 'Department of Rehabilitation, Saitama Medical University International Medical Center, Yamane, Hidaka, Saitama, Japan.'}]",Physical therapy,['10.1093/ptj/pzab114']
1158,33870612,Patients' experiences and perspectives of a mobile phone text messaging intervention to improve dietary behaviours in haemodialysis.,"AIM


Dietary requirements for people on haemodialysis are complex and often poorly adhered to. Mobile phone text messaging offers a simple strategy to enhance current nutritional care. KIDNEYTEXT was a 6-month pilot randomised controlled trial that evaluated the feasibility and impact of mobile phone text messages to alter participants' dietary behaviours. The aim of this study was to elicit the perspectives of people on haemodialysis regarding acceptability of mobile phone text messages targeting dietary behaviours.
METHODS


Semi-structured interviews were conducted with participants in the intervention arm of the KIDNEYTEXT study. Participants were purposively sampled and interviews were conducted in-person or over the phone. Transcripts were thematically analysed using principles of grounded theory.
RESULTS


Interviews were conducted with 25 participants. Four major themes were identified: building awareness (reinforcement of information, simple and comprehensible, guiding choices, accessible information enhancing motivation, gaining skills in management), valuing care (boosting self-esteem, in-person care bolstered by reminders), activating change (adjusting lifestyle, gaining control of electrolytes and fluid, striving to improve overall health), waning attention and motivation (lack of personalisation limiting change, maintaining the status quo, reverting back to old habits).
CONCLUSIONS


Participants perceived that the KIDNEYTEXT intervention enabled participants to build on their knowledge through the dissemination of simple and actionable content. Participants appreciated frequent reminders of how to improve their diet and felt that this increased contact motivated them to alter some dietary behaviours. Future trials should consider strategies to enhance personalisation to further motivate dietary change.",2021,"Four major themes were identified: building awareness (reinforcement of information, simple and comprehensible, guiding choices, accessible information enhancing motivation, gaining skills in management), valuing care (boosting self-esteem, in-person care bolstered by reminders), activating change (adjusting lifestyle, gaining control of electrolytes and fluid, striving to improve overall health), waning attention and motivation (lack of personalisation limiting change, maintaining the status quo, reverting back to old habits).
","['Semi-structured interviews were conducted with participants in the intervention arm of the KIDNEYTEXT study', ""participants' dietary behaviours"", 'Interviews were conducted with 25 participants']","['mobile phone text messages', 'building awareness (reinforcement of information, simple and comprehensible, guiding choices, accessible information enhancing motivation, gaining skills in management), valuing care (boosting self-esteem, in-person care bolstered by reminders), activating change (adjusting lifestyle, gaining control of electrolytes and fluid, striving to improve overall health), waning attention and motivation (lack of personalisation limiting change, maintaining the status quo, reverting back to old habits', 'KIDNEYTEXT intervention', 'mobile phone text messaging intervention']",[],"[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]",[],25.0,0.0702165,"Four major themes were identified: building awareness (reinforcement of information, simple and comprehensible, guiding choices, accessible information enhancing motivation, gaining skills in management), valuing care (boosting self-esteem, in-person care bolstered by reminders), activating change (adjusting lifestyle, gaining control of electrolytes and fluid, striving to improve overall health), waning attention and motivation (lack of personalisation limiting change, maintaining the status quo, reverting back to old habits).
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'Faculty of Medicine and Health, Sydney Medical School, Westmead Clinical School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Tong', 'Affiliation': ""Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Matus Gonzalez', 'Affiliation': ""Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.""}, {'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'Healthcare Excellence and Innovation, Metro North Hospital and Health Service, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Craig', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Vincent W', 'Initials': 'VW', 'LastName': 'Lee', 'Affiliation': 'Faculty of Medicine and Health, Sydney Medical School, Westmead Clinical School, The University of Sydney, Sydney, New South Wales, Australia.'}]",Nutrition & dietetics: the journal of the Dietitians Association of Australia,['10.1111/1747-0080.12667']
1159,33866584,Anaemia in elderly patients at discharge from intensive care and hospital.,"BACKGROUND AND OBJECTIVES


Anaemia is common in the elderly and is recognized as a risk factor for several adverse outcomes in older adults, including hospitalization, morbidity and mortality. The study aims were to examine the prevalence of anaemia in elderly patients at discharge from the intensive care unit (ICU) and hospital.
MATERIALS AND METHODS


Patient randomized under the INFORM trial and with an ICU admission were included. Two cohorts, Cohort 1 patients who were alive on discharge from ICU and Cohort 2 patients who were discharged alive from hospital to home. Prevalence of significant anaemia defined as haemoglobin levels, less than 100 g/l was measured at ICU and hospital discharge.
RESULTS


Overall, 76·5% (683/893) of elderly admissions in Cohort 1 had a haemoglobin <100 g/l, and 44·1% (395/893) had a haemoglobin <90 g/l on ICU discharge. Nadir haemoglobin during ICU stay, length of stay in ICU and transfusion during ICU stay was associated with significant anaemia at ICU discharge. At hospital discharge, in Cohort 2, 54·8% (263/480) of elderly ICU admissions had Hb < 100 g/l, and 23·4% (112/480) had Hb < 90 g/l. Male gender, haemoglobin level at ICU discharge, and length of stay and nadir Hb between ICU and hospital discharge were associated with anaemia at hospital discharge.
CONCLUSIONS


Significant anaemia is highly prevalent in elderly patients on discharge from ICU and to a lesser degree at hospital discharge.",2021,"Nadir haemoglobin during ICU stay, length of stay in ICU and transfusion during ICU stay was associated with significant anaemia at ICU discharge.","['Patient randomized under the INFORM trial and with an ICU admission were included', 'elderly patients at discharge from the intensive care unit (ICU) and hospital', 'older adults', 'elderly patients at discharge from intensive care and hospital', 'elderly patients', 'Two cohorts, Cohort 1 patients who were alive on discharge from ICU and Cohort 2 patients who were discharged alive from hospital to home']",['haemoglobin'],"['haemoglobin levels', 'Male gender, haemoglobin level at ICU discharge, and length of stay and nadir', 'haemoglobin', 'prevalence of anaemia', 'Nadir haemoglobin during ICU stay, length of stay in ICU and transfusion during ICU stay', 'Anaemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",,0.168521,"Nadir haemoglobin during ICU stay, length of stay in ICU and transfusion during ICU stay was associated with significant anaemia at ICU discharge.","[{'ForeName': 'Romi', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Molecular Medicine & Pathology, College of Medicine & Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hakendorf', 'Affiliation': 'Department of Clinical Epidemiology, Flinders Medical Centre, Bedford Park, SA, Australia.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Sobieraj-Teague', 'Affiliation': 'Department of Haematology, Flinders Medical Centre, Bedford Park, SA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roxby', 'Affiliation': 'Molecular Medicine & Pathology, College of Medicine & Public Health, Flinders University, Adelaide, SA, Australia.'}]",Vox sanguinis,['10.1111/vox.13109']
1160,33866522,Analgesic Effects of Navigated Repetitive Transcranial Magnetic Stimulation in Patients With Acute Central Poststroke Pain.,"INTRODUCTION


Central poststroke pain (CPSP) develops commonly after stroke, which impairs the quality of life, mood, and social functioning. Current pharmacological approaches for the treatment of CPSP are not satisfactory. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique which has been recommended for the treatment of chronic CPSP. However, few studies have evaluated the analgesic effects of rTMS in patients with acute neuropathic pain after stroke.
METHODS


We evaluated the analgesic effects of rTMS applied over the upper extremity area of the motor cortex (M1) in patients with acute CPSP. Forty patients were randomized to receive either rTMS (10 Hz, 2000 stimuli) (n = 20) or a sham intervention (n = 20) for 3 weeks. The Numeric Rating Scale (NRS), Short-form McGill Pain Questionnaire-2 (SF-MPQ-2, Chinese version), Hamilton Anxiety Scale (HAM-A), Hamilton Depression Scale (HAM-D), brain-derived neurotrophic factor (BDNF) levels, and motor-evoked potentials (MEP) were analyzed at baseline, 3 days, 1 week, 2 weeks, and 3 weeks.
RESULTS


Significant treatment-time interactions were found for pain intensity. Compared with the sham group, the NRS and SF-MPQ-2 scores were significantly lower on the seventh day of treatment in the rTMS group (P < 0.001, Cohen's d = 1.302) (P = 0.003, Cohen's d = 0.771), and this effect lasted until the third week (P = 0.001, Cohen's d = 0.860) (P = 0.027, Cohen's d = 0.550). The HAM-A and HAM-D scores did not change in the rTMS group when compared with the sham group (P = 0.341, Cohen's d = 0.224) (P = 0.356, Cohen's d = 0.217). The serum BDNF levels were significantly higher in the treated group (P = 0.048, Cohen's d = -0.487), and the resting motor threshold (RMT) decreased by 163.65%.
CONCLUSION


Our findings indicate that rTMS applied over the upper extremity area of the motor cortex can effectively alleviate acute CPSP, possibly by influencing cortical excitability and serum BDNF secretion.
TRIAL REGISTRATION


This trial is registered with Clinical Trial Registry of China: Reg. No. ChiCTR-INR-17012880.",2021,"The HAM-A and HAM-D scores did not change in the rTMS group when compared with the sham group (P = 0.341, Cohen's d = 0.224) (P = 0.356, Cohen's d = 0.217).","['Patients With Acute Central Poststroke Pain', 'patients with acute CPSP', 'Forty patients', 'patients with acute neuropathic pain after stroke']","['rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', 'Navigated Repetitive Transcranial Magnetic Stimulation', 'sham intervention']","['Numeric Rating Scale (NRS), Short-form McGill Pain Questionnaire-2 ', 'resting motor threshold (RMT', 'SF-MPQ-2, Chinese version), Hamilton Anxiety Scale (HAM-A), Hamilton Depression Scale (HAM-D), brain-derived neurotrophic factor (BDNF) levels, and motor-evoked potentials (MEP', 'HAM-A and HAM-D scores', 'pain intensity', 'serum BDNF levels', 'NRS and SF-MPQ-2 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",40.0,0.0173768,"The HAM-A and HAM-D scores did not change in the rTMS group when compared with the sham group (P = 0.341, Cohen's d = 0.224) (P = 0.356, Cohen's d = 0.217).","[{'ForeName': 'Chen-Guang', 'Initials': 'CG', 'LastName': 'Zhao', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Ju', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Rehabilitation Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiao-Long', 'Initials': 'XL', 'LastName': 'Sun', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Mou', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China. yuanhua_fmmu@hotmail.com.""}]",Pain and therapy,['10.1007/s40122-021-00261-0']
1161,33888772,Effect of linagliptin on glucose metabolism and pancreatic beta cell function in patients with persistent prediabetes after metformin and lifestyle.,"The goal of the study was to evaluate the effect of adding linagliptin to metformin and lifestyle on glucose levels and pancreatic β-cell function in patients with persistent impaired glucose tolerance (IGT) after 12 months of metformin and lifestyle. A single center parallel double-blind randomized clinical trial with 6 months of follow-up was performed in patients with persistent IGT after 12 months of treatment with metformin and lifestyle; patients were randomized to continue with metformin 850 mg twice daily (M group, n = 12) or linagliptin/metformin 2.5/850 mg twice daily (LM group, n = 19). Anthropometric measurements were obtained by standard methods and by bioelectrical impedance; glucose was measured by dry chemistry, insulin by chemiluminescence, and pancreatic β-cell function was calculated with the disposition index using glucose and insulin values during oral glucose tolerance test (OGTT) and adjusting by insulin sensitivity. The main outcomes were glucose levels during OGTT and pancreatic β-cell function. Patients in the LM group had a reduction in weight (-1.7 ± 0.6, p < 0.05) and body mass index (BMI, -0.67 ± 0.2, p < 0.05). Glucose levels significantly improved in LM group with a greater reduction in the area under the glucose curve during OGTT (AUCGluc 0_120min ) as compared to the M group (-4425 ± 871 vs -1116 ± 1104 mg/dl/120 min, p < 0.001). Pancreatic β-cell function measured with the disposition index, improved only in LM group (2.3 ± 0.23 vs 1.7 ± 0.27, p 0.001); these improvements persisted after controlling for OGTT glucose levels. The differences in pancreatic β-cell function persisted also after pairing groups for basal AUCGluc 0_120min . The addition of linagliptin to patients with persistent IGT after 12 months of treatment with metformin and lifestyle, improved glucose levels during OGTT and pancreatic β-cell function after 6 months of treatment.Trial registration: Clinicaltrials.gov with the ID number NCT04088461.",2021,"Patients in the LM group had a reduction in weight (-1.7 ± 0.6, p < 0.05) and body mass index (BMI, -0.67 ± 0.2, p < 0.05).","['patients with persistent prediabetes after metformin and lifestyle', 'patients with persistent impaired glucose tolerance (IGT) after 12\xa0months of metformin and lifestyle', 'patients with persistent IGT after 12\xa0months of treatment with metformin and lifestyle; patients']","['linagliptin/metformin', 'metformin', 'linagliptin to metformin', 'linagliptin', 'metformin 850\xa0mg twice daily (M group, n\u2009=\u200912) or', 'LM']","['Glucose levels', 'glucose levels and pancreatic β-cell function', 'Pancreatic β-cell function', 'glucose levels during OGTT and pancreatic β-cell function', 'glucose metabolism and pancreatic beta cell function', 'pancreatic β-cell function', 'body mass index', 'dry chemistry, insulin by chemiluminescence, and pancreatic β-cell function', 'reduction in weight', 'disposition index using glucose and insulin values during oral glucose tolerance test (OGTT) and adjusting by insulin sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3264599', 'cui_str': 'metformin and linagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007996', 'cui_str': 'Chemistry'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0162524', 'cui_str': 'Chemiluminescence, Physical'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",,0.127355,"Patients in the LM group had a reduction in weight (-1.7 ± 0.6, p < 0.05) and body mass index (BMI, -0.67 ± 0.2, p < 0.05).","[{'ForeName': 'Mildred Fátima de la Luz', 'Initials': 'MFL', 'LastName': 'Alvarez-Canales', 'Affiliation': 'Department of Medicine and Nutrition, University of Guanajuato, León, Guanajuato, Mexico.'}, {'ForeName': 'Sara Stephania', 'Initials': 'SS', 'LastName': 'Salazar-López', 'Affiliation': 'Department of Medicine and Nutrition, University of Guanajuato, León, Guanajuato, Mexico.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Farfán-Vázquez', 'Affiliation': 'Department of Medicine and Nutrition, University of Guanajuato, León, Guanajuato, Mexico.'}, {'ForeName': 'Yosceline Estrella', 'Initials': 'YE', 'LastName': 'Martínez-López', 'Affiliation': 'Department of Medicine and Nutrition, University of Guanajuato, León, Guanajuato, Mexico.'}, {'ForeName': 'Jessica Noemí', 'Initials': 'JN', 'LastName': 'González-Mena', 'Affiliation': 'Department of Medicine and Nutrition, University of Guanajuato, León, Guanajuato, Mexico.'}, {'ForeName': 'Lilia Marisela', 'Initials': 'LM', 'LastName': 'Jiménez-Ceja', 'Affiliation': 'Department of Medicine and Nutrition, University of Guanajuato, León, Guanajuato, Mexico.'}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Vargas-Ortiz', 'Affiliation': 'Department of Medical Sciences, University of Guanajuato, León, Guanajuato, Mexico.'}, {'ForeName': 'María Lola', 'Initials': 'ML', 'LastName': 'Evia-Viscarra', 'Affiliation': 'Endocrinology Department Hospital Regional de Alta Especialidad del Bajío, León, Guanajuato, Mexico.'}, {'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'Montes de Oca-Loyola', 'Affiliation': 'Department of Medicine and Nutrition, University of Guanajuato, León, Guanajuato, Mexico.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Folli', 'Affiliation': ""Endocrinology and Metabolism Dipartimento Di Scienze Della Salute, Universita' Degli Studi Di Milano, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Aguilar-García', 'Affiliation': 'Endocrinology Department Hospital Regional de Alta Especialidad del Bajío, León, Guanajuato, Mexico.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Guardado-Mendoza', 'Affiliation': 'Department of Medicine and Nutrition, University of Guanajuato, León, Guanajuato, Mexico. guardamen@gmail.com.'}]",Scientific reports,['10.1038/s41598-021-88108-8']
1162,33901103,Using Novel Approaches to Evaluate Behavioral Interventions: Overlooked Significant HIV Prevention Effects in the HPTN 015 Project EXPLORE.,"BACKGROUND


Mediated and moderated processes that lead to intervention efficacy may underlie results of trials ruled as nonefficacious. The overall purpose of this study was to examine such processes to explain the findings of one of the largest, rigorously conducted behavioral intervention randomized controlled trials, EXPLORE.
METHODS


Four thousand two hundred ninety-five HIV-negative men who have sex with men (MSM) in the United States were randomized in a 2-armed trial. Participants completed follow-up and an HIV test every 6 months up to 48 months. We used multiple and causal mediation analyses to test 5 mediators, including safer sex self-efficacy and condomless receptive anal sex with HIV-positive or status-unknown partners on our primary outcome (HIV seroconversion). We also examined whether intervention effects on the mediators would be moderated by robust correlates of HIV among MSM, including stimulant use.
RESULTS


There were significant effects of the intervention on all hypothesized mediators. Stimulant use moderated the effect on condomless receptive anal sex In stratified multiple mediation models, we found that among MSM with low stimulant use, the intervention significantly prevented HIV by reducing condomless receptive anal sex with HIV-positive or status-unknown partners. Among MSM with higher stimulant use, there were no indirect effects of the intervention on HIV through any of the hypothesized mediators.
CONCLUSION


The results suggest that the null effect found in the original EXPLORE trial might have occurred as a function of previously unexplored mediated and moderated processes. This study illustrates the value of testing mediated and moderated pathways in randomized trials, even in trials ruled out as nonefficacious.",2021,"Among MSM with higher stimulant use, there were no indirect effects of the intervention on HIV through any of the hypothesized mediators.
","['4,295 HIV-negative MSM in the U.S']",[],['condomless receptive anal sex'],"[{'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}]",[],"[{'cui': 'C0282347', 'cui_str': 'Anal sex'}]",4295.0,0.0906401,"Among MSM with higher stimulant use, there were no indirect effects of the intervention on HIV through any of the hypothesized mediators.
","[{'ForeName': 'Eileen V', 'Initials': 'EV', 'LastName': 'Pitpitan', 'Affiliation': 'School of Social Work, San Diego State University, San Diego, CA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'MacKinnon', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Eaton', 'Affiliation': 'Department of Human, Development and Family Sciences, University of Connecticut, Storrs, CT; and.'}, {'ForeName': 'Laramie R', 'Initials': 'LR', 'LastName': 'Smith', 'Affiliation': 'Departments of Medicine, and Psychiatry University of California San Diego, San Diego, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wagman', 'Affiliation': 'Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Patterson', 'Affiliation': 'Departments of Medicine, and Psychiatry University of California San Diego, San Diego, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002711']
1163,33928908,Treatment of chronic primary sleep onset insomnia with Kundalini yoga: a randomized controlled trial with active sleep hygiene comparison.,"STUDY OBJECTIVES


Prior studies have suggested a benefit of yoga for alleviating sleep disturbance; however, many studies have had methodological limitations. This trial study aimed to extend that literature by including an active sleep hygiene comparison.
METHODS


Participants aged 25-59 years with a primary complaint of sleep onset insomnia lasting at least 6 months were block randomized to an 8-week Kundalini yoga or sleep hygiene intervention, both consisting of initial 60-minute instruction and weekly check-ins. Daily sleep diaries and questionnaires were collected at baseline, throughout the intervention, and at 6-month follow-up. Data were analyzed using linear mixed models (n = 20 in each group).
RESULTS


Participant ratings of the interventions did not significantly differ. Sleep hygiene improved several diary and questionnaire outcomes, however, yoga resulted in even greater improvements corresponding to medium-to-large between-group effect sizes. Total sleep time increased progressively across yoga treatment ( d  = 0.95,  P  = .002), concurrent with increased sleep efficiency ( d  = 1.36,  P  < .001) and decreased sleep onset latency ( d  = -1.16,  P  < .001), but without changes in pre-sleep arousal ( d  =-0.30,  P  = .59). Remission rates were also higher for yoga compared to sleep hygiene, with ≥ 80% of yoga participants reporting average sleep onset latency < 30 minutes and sleep efficiency > 80% at 6-month follow-up. For over 50% of yoga participants, the insomnia severity index decreased by at least 8 points at end of treatment and follow-up.
CONCLUSIONS


Yoga, taught in a self-care framework with minimal instructor burden, was associated with self-reported improvements above and beyond an active sleep hygiene comparison, sustained at 6-month follow-up. Follow-up studies are needed to assess actigraphy and polysomnography outcomes, as well as possible mechanisms of change.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Yoga as a Treatment for Insomnia; URL: https://clinicaltrials.gov/ct2/show/NCT00033865; Identifier: NCT00033865.
CITATION


Khalsa SBS, Goldstein MR. Treatment of chronic primary sleep onset insomnia with Kundalini yoga: a randomized controlled trial with active sleep hygiene comparison.  J Clin Sleep Med . 2021;17(9):1841-1852.",2021,"Total sleep time increased progressively across yoga treatment (d=0.95, p=.002), concurrent with increased sleep efficiency (SE; d=1.36, p<.001) and decreased sleep onset latency (SOL; d=-1.16, p<.001), but without changes in pre-sleep arousal (d=-0.30, p=.59).","['chronic primary sleep onset insomnia with Kundalini Yoga', 'Participants aged 25-59 with a primary complaint of sleep onset insomnia lasting at least six months']","['Kundalini Yoga or SH intervention, both consisting of initial 60-minute instruction and weekly check-ins']","['Remission rates', 'Daily sleep diaries and questionnaires', 'sleep onset latency', 'pre-sleep arousal', 'SH improved several diary and questionnaire outcomes', 'insomnia severity index', 'Total sleep time', 'sleep efficiency']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.168101,"Total sleep time increased progressively across yoga treatment (d=0.95, p=.002), concurrent with increased sleep efficiency (SE; d=1.36, p<.001) and decreased sleep onset latency (SOL; d=-1.16, p<.001), but without changes in pre-sleep arousal (d=-0.30, p=.59).","[{'ForeName': 'Sat Bir S', 'Initials': 'SBS', 'LastName': 'Khalsa', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Goldstein', 'Affiliation': 'Division of Sleep Medicine, Harvard Medical School, Boston, Massachusetts.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9320']
1164,33901759,A randomized control trial of a child abuse mandated reporter training: Knowledge and attitudes.,"BACKGROUND


Despite being well-positioned to identify maltreatment in the children that they provide care for and being legally required to report suspected child maltreatment, early childhood professionals (ECPs) make a limited proportion of reports to child protective services. It is critical to identify evidence-based interventions to improve the reporting practices of this group of mandated reporters allowing for the better protection of children from maltreatment.
OBJECTIVE


The goal of the present study was to determine if iLookOut, an online child abuse identification and reporting training for ECPs, results in differential gains in knowledge and attitudes towards child abuse and its reporting among ECPs, as compared to an online standard training.
PARTICIPANTS AND SETTING


Both interventions were completed online by participants recruited from licensed child care programs in Southern Maine from October 2017 to January 2020. Eligibility criteria included being at least 18 years of age, English-speaking, and working as paid or volunteer staff at a licensed child care program taking care of children 5 years of age or younger. Of the 1152 enrolled individuals, 1094 provided complete pre- and post-intervention data.
METHODS


A randomized controlled trial comparing iLookOut with an online standard training.
RESULTS


ECPs who completed iLookOut significantly outperformed those who completed Standard mandated reporter training in terms of both knowledge (d=1.09 vs. 0.67) and attitudes (d=0.67 vs. 0.54) relative to pre-test scores.
CONCLUSIONS


iLookOut is a promising candidate for widespread use in meeting the need for evidence-based training on child abuse and its reporting.",2021,"RESULTS


ECPs who completed iLookOut significantly outperformed those who completed Standard mandated reporter training in terms of both knowledge (d=1.09 vs. 0.67) and attitudes (d=0.67 vs. 0.54) relative to pre-test scores.
","['1152 enrolled individuals, 1094 provided complete pre- and post-intervention data', 'Eligibility criteria included being at least 18 years of age, English-speaking, and working as paid or volunteer staff at a licensed child care program taking care of children 5 years of age or younger', 'Both interventions were completed online by participants recruited from licensed child care programs in Southern Maine from October 2017 to January 2020']","['iLookOut with an online standard training', 'child abuse mandated reporter training']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0024497', 'cui_str': 'Maine'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0335038', 'cui_str': 'Reporter'}]",[],1152.0,0.0276078,"RESULTS


ECPs who completed iLookOut significantly outperformed those who completed Standard mandated reporter training in terms of both knowledge (d=1.09 vs. 0.67) and attitudes (d=0.67 vs. 0.54) relative to pre-test scores.
","[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Humphreys', 'Affiliation': 'Vanderbilt University, Nashville, TN, United States. Electronic address: k.humphreys@vanderbilt.edu.'}, {'ForeName': 'Hannah A', 'Initials': 'HA', 'LastName': 'Piersiak', 'Affiliation': 'Vanderbilt University, Nashville, TN, United States.'}, {'ForeName': 'Carlomagno C', 'Initials': 'CC', 'LastName': 'Panlilio', 'Affiliation': 'Pennsylvania State University, Hershey, PA, United States.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Lehman', 'Affiliation': 'Pennsylvania State College of Medicine, Hershey, PA, United States.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Verdiglione', 'Affiliation': 'Pennsylvania State College of Medicine, Hershey, PA, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dore', 'Affiliation': 'Pennsylvania State College of Medicine, Hershey, PA, United States.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Levi', 'Affiliation': 'Pennsylvania State College of Medicine, Hershey, PA, United States.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.105033']
1165,33909260,"Effects of Shuanghuanglian oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinical trial.","We conducted a randomized, open-label, parallel-controlled, multicenter trial on the use of Shuanghuanglian (SHL), a traditional Chinese patent medicine, in treating cases of COVID-19. A total of 176 patients received SHL by three doses (56 in low dose, 61 in middle dose, and 59 in high dose) in addition to standard care. The control group was composed of 59 patients who received standard therapy alone. Treatment with SHL was not associated with a difference from standard care in the time to disease recovery. Patients with 14-day SHL treatment had significantly higher rate in negative conversion of SARS-CoV-2 in nucleic acid swab tests than the patients from the control group (93.4% vs. 73.9%, P = 0.006). Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia, which was evaluated by density reduction of inflammatory focus from baseline, at day 7 (mean difference (95% CI), -46.39 (-86.83 to -5.94) HU; P = 0.025) and day 14 (mean difference (95% CI), -74.21 (-133.35 to -15.08) HU; P = 0.014). No serious adverse events occurred in the SHL groups. This study illustrated that SHL in combination with standard care was safe and partially effective for the treatment of COVID-19.",2021,"Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia, which was evaluated by density reduction of inflammatory focus from baseline, at day 7 (mean difference (95% CI), -46.39 (-86.83 to -5.94) HU; P = 0.025) and day 14 (mean difference (95% CI), -74.21 (-133.35 to -15.08)","['patients with COVID-19', '176 patients received']","['Shuanghuanglian oral liquids', 'Shuanghuanglian (SHL', 'SHL', 'standard therapy alone']","['absorption of inflammatory focus of pneumonia', 'serious adverse events', 'rate in negative conversion of SARS-CoV-2 in nucleic acid swab tests']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C1273619', 'cui_str': 'Oral Liquid Product'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",176.0,0.0937014,"Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia, which was evaluated by density reduction of inflammatory focus from baseline, at day 7 (mean difference (95% CI), -46.39 (-86.83 to -5.94) HU; P = 0.025) and day 14 (mean difference (95% CI), -74.21 (-133.35 to -15.08)","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ni', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230026, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China.'}, {'ForeName': 'Haisheng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Harbin Pharmaceutical Group Co., Ltd., Harbin, 150070, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Lujin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Xizhen', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Xiao', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Zongzhe', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Chene', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Yujian', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Runhua', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Jinliang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Sixth Hospital of Harbin, Harbin, 150036, China.'}, {'ForeName': 'Yongxiang', 'Initials': 'Y', 'LastName': 'Yi', 'Affiliation': 'The Second Hospital of Nanjing and the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210003, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Information Management, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Division of Respiratory, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zuo', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China. jpzuo@simm.ac.cn.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': 'The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230026, China. wengjp@ustc.edu.cn.'}, {'ForeName': 'Hualiang', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China. hljiang@simm.ac.cn.'}, {'ForeName': 'Dao Wen', 'Initials': 'DW', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. dwwang@tjh.tjmu.edu.cn.'}]",Frontiers of medicine,['10.1007/s11684-021-0853-6']
1166,33914304,Application of online-offline integrated medical care management in patients with gestational diabetes.,"OBJECTIVES


To investigate efficacy of online-offline integrated medical care management in patients with gestational diabetes.
MATERIAL AND METHODS


A total of 140 patients with gestational diabetes were randomly divided into two groups: integrated management (IM) group (n = 70) and control group (n = 70). Patients in the control group were treated with routine nursing intervention, and the patients in the IM group were treated with integrated care (offline medical and nursing management combined with WeChat online management). The fasting plasma glucose (FPG), 2h postprandial plasma glucose (2hPG), Self-rating Anxiety Scale (SAS) score, Self-rating Depression Scale (SDS) score, Diabetes Care Profile (DPC) score, 36-item Short-Form (SF-36) score, and poor pregnancy outcomes were compared between the two groups.
RESULTS


After intervention, the FPG, 2hPG, SAS score, SDS score, DPC score and SF-36 score were improved in both groups. All indicators in the IM group were better than the control group (p < 0.05). The incidence of premature delivery, polyhydramnios, neonatal respiratory distress, intrauterine distress, and postpartum hemorrhage in the IM group were lower than those in the control group (p < 0.05).
CONCLUSIONS


The online-offline integrated medical care management effectively improved the blood glucose level, mental state, self-management behavior, quality of life and pregnancy outcomes of patients with gestational diabetes.",2021,All indicators in the IM group were better than the control group (p < 0.05).,"['140 patients with gestational diabetes', 'patients with gestational diabetes']","['routine nursing intervention', 'integrated care (offline medical and nursing management combined with WeChat online management', 'online-offline integrated medical care management']","['blood glucose level, mental state, self-management behavior, quality of life and pregnancy outcomes', 'fasting plasma glucose (FPG), 2h postprandial plasma glucose (2hPG), Self-rating Anxiety Scale (SAS) score, Self-rating Depression Scale (SDS) score, Diabetes Care Profile (DPC) score, 36-item Short-Form (SF-36) score, and poor pregnancy outcomes', 'FPG, 2hPG, SAS score, SDS score, DPC score and SF-36 score', 'incidence of premature delivery, polyhydramnios, neonatal respiratory distress, intrauterine distress, and postpartum hemorrhage']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0020224', 'cui_str': 'Polyhydramnios'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}]",140.0,0.0134515,All indicators in the IM group were better than the control group (p < 0.05).,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': '6th Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': '6th Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ""2nd People's Hospital of Lianyungang, Jiangsu Province, China.""}, {'ForeName': 'Chenhui', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': '6th Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Jinling', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""2nd People's Hospital of Lianyungang, Jiangsu Province, China. jinling988@163.com.""}]",Ginekologia polska,['10.5603/GP.a2021.0054']
1167,33891721,Effectiveness of Intermittent Preventive Treatment With Dihydroartemisinin-Piperaqunine Against Malaria in Pregnancy in Tanzania: A Randomized Controlled Trial.,"Intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP) to prevent malaria and adverse birth outcomes is threatened by Plasmodium falciparum resistance to sulfadoxine-pyrimethamine. We investigated the effectiveness of intermittent preventive treatment in pregnancy with monthly dihydroartemisinin-piperaquine (IPTp-DHP) as an alternative option to IPTp-SP. A total of 956 malaria-free (malaria rapid diagnostic test (MRDT) negative) pregnant women from moderate malaria transmission areas in Tanzania were enrolled and randomized to receive monthly IPTp-DHP (n = 478) or IPTp-SP (n = 478) and followed for maternal and birth outcomes. The primary outcome was the prevalence of histopathologically confirmed placental malaria (active or past infection). Secondary outcomes were overall malaria at delivery, symptomatic-malaria, parasitemia during pregnancy, and adverse birth outcomes as a composite of spontaneous-abortion, premature birth, stillbirth, and low birth weight (LBW) fetal anemia. Outcome differences between treatment groups were expressed as the protective efficacy (PE), defined as 1-prevalence ratios or 1-incidence rate ratio. The prevalence of histopathologically confirmed placental malaria was significantly lower in IPTp-DHP (2.5%, 12/478) than IPTp-SP (8.2%, 39/478); PE = 69% (95% confidence interval (CI): 42-84, P < 0.001). The prevalence of maternal malaria at delivery was significantly lower in IPTp-DHP (8.2%) than IPTp-SP (18.2%, P < 0.001). The incidence per person-years at risk for symptomatic-malaria (0.02 vs. 0.12, P = 0.002) and parasitemia during pregnancy (0.28 vs. 0.67, P < 0.001) were significantly lower in the IPTp-DHP group than in the IPTp-SP group. The prevalence of any adverse birth outcomes (composite) was not significantly (P = 0.06) different between IPTp-DHP (17.9%) and IPTp-SP (23.8%). However, the prevalence of LBW (4.6% vs. 9.6%, P = 0.003) was significantly lower in IPTp-DHP compared with IPTp-SP. We report superior protective efficacy of monthly IPTp-DHP against malaria in pregnancy and LBW than IPTp-SP.",2021,The prevalence of any adverse birth outcomes (composite) was not significantly (p=0.06) different between IPTp-DHP (17.9%) and IPTp-SP (23.8%).,"['956 malaria-free (mRDT negative) pregnant women from moderate malaria transmission areas in Tanzania', 'pregnancy in Tanzania']","['monthly IPTp-DHP (n=478) or IPTp-SP', 'sulfadoxine-pyrimethamine (IPTp-SP', 'monthly Dihydroartemisinin-piperaquine (IPTp-DHP', 'dihydroartemisinin-piperaqunine', 'sulfadoxine-pyrimethamine', 'monthly IPTp-DHP']","['parasitemia during pregnancy', 'overall malaria at delivery, symptomatic-malaria, parasitemia during pregnancy, and adverse birth outcomes as a composite of spontaneous-abortion, premature birth, stillbirth, low birth weight (LBW) fetal anemia', 'prevalence of histopathologically confirmed placental malaria', 'incidence of symptomatic-malaria', 'prevalence of LBW', 'prevalence of maternal malaria at delivery', 'protective efficacy (PE), defined as 1-prevalence ratios or 1-incidence rate ratio', 'prevalence of any adverse birth outcomes (composite', 'prevalence of histopathologically confirmed placental malaria (active or past infection']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C2349595', 'cui_str': 'Fetal anemia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",956.0,0.218423,The prevalence of any adverse birth outcomes (composite) was not significantly (p=0.06) different between IPTp-DHP (17.9%) and IPTp-SP (23.8%).,"[{'ForeName': 'Eulambius M', 'Initials': 'EM', 'LastName': 'Mlugu', 'Affiliation': 'Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Omary', 'Initials': 'O', 'LastName': 'Minzi', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Appolinary A R', 'Initials': 'AAR', 'LastName': 'Kamuhabwa', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Aklillu', 'Affiliation': 'Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2273']
1168,33894423,Oxytocinergic Modulation of Threat-Specific Amygdala Sensitization in Humans Is Critically Mediated by Serotonergic Mechanisms.,"BACKGROUND


Overarching conceptualizations propose that the complex social-emotional effects of oxytocin (OXT) in humans are partly mediated by interactions with other neurotransmitter systems. Recent animal models suggest that the anxiolytic effects of OXT are critically mediated by the serotonin (5-HT) system, yet direct evidence in humans is lacking.
METHODS


To determine the role of 5-HT in OXT-induced attenuation of amygdala threat reactivity and sensitization/desensitization, we conducted a parallel-group, randomized, placebo-controlled, double-blind experiment during which 121 healthy subjects underwent a transient decrease in 5-HT signaling via acute tryptophan depletion or the corresponding placebo-control protocol before the administration of intranasal OXT or placebo intranasal spray, respectively. Mean and repetition-dependent changes in threat-specific amygdala reactivity toward threatening stimuli (angry faces) as assessed by functional magnetic resonance imaging served as the primary outcome.
RESULTS


No main or interaction effects of treatment on amygdala threat reactivity were observed, yet OXT switched bilateral amygdala threat sensitization to desensitization, and this effect was significantly attenuated during decreased central 5-HT signaling via pretreatment with acute tryptophan depletion.
CONCLUSIONS


The present findings provide the first evidence for a role of OXT in threat-specific amygdala desensitization in humans and suggest that these effects are critically mediated by the 5-HT system. OXT may have a therapeutic potential to facilitate amygdala desensitization, and adjunct upregulation of 5-HT neurotransmission may facilitate OXT's anxiolytic potential.",2021,OXT may have a therapeutic potential to facilitate amygdala desensitization and adjunct up-regulation of 5-HT neurotransmission may facilitate OXT's anxiolytic potential.,['n = 121 healthy subjects underwent a transient decrease in 5-HT signaling via acute tryptophan depletion (ATD + ) or the corresponding placebo-control protocols before the administration of'],"['oxytocin (OXT', 'OXT', '5-HT', 'placebo', 'intranasal OXT or placebo intranasal spray']","['Mean and repetition-dependent changes in threat-specific amygdala reactivity towards threatening stimuli (angry faces', 'amygdala threat reactivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",121.0,0.153413,OXT may have a therapeutic potential to facilitate amygdala desensitization and adjunct up-regulation of 5-HT neurotransmission may facilitate OXT's anxiolytic potential.,"[{'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Clinical Hospital of the Chengdu Brain Science Institute, School of Life Science and Technology, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Lan', 'Affiliation': 'Clinical Hospital of the Chengdu Brain Science Institute, School of Life Science and Technology, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Keshuang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Clinical Hospital of the Chengdu Brain Science Institute, School of Life Science and Technology, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Shuxia', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Clinical Hospital of the Chengdu Brain Science Institute, School of Life Science and Technology, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Clinical Hospital of the Chengdu Brain Science Institute, School of Life Science and Technology, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Clinical Hospital of the Chengdu Brain Science Institute, School of Life Science and Technology, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xinqi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Clinical Hospital of the Chengdu Brain Science Institute, School of Life Science and Technology, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning, IDG/McGovern Institute of Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yong', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning, IDG/McGovern Institute of Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Yina', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning, IDG/McGovern Institute of Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany; Department of Psychiatry, School of Medicine & Health Sciences, University of Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'Clinical Hospital of the Chengdu Brain Science Institute, School of Life Science and Technology, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'Clinical Hospital of the Chengdu Brain Science Institute, School of Life Science and Technology, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China. Electronic address: ben_becker@gmx.de.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2021.04.009']
1169,33901566,Optimizing Treatment in Intermediate-Risk Prostate Cancer: Secondary Analysis of a Randomized Phase 3 Trial.,"PURPOSE


To identify patients with intermediate-risk prostate cancer (IRPC) benefiting from de-escalation of androgen deprivation therapy (ADT) and/or dose escalated radiation therapy (DERT), we performed a secondary analysis of a phase 3 trial by measuring biochemical failure (BF), distant metastases, prostate cancer-specific mortality, overall survival (OS), and distant metastases-free survival (DMFS) rates according to prognostic intermediate risk factors (IRF).
METHODS AND MATERIALS


The initial trial randomized 600 patients with IRPC to a 3-arm trial with 200 patients per arm, consisting of 6 months of ADT plus 70 Gy radiation therapy (ADT + RT70) versus ADT plus a DERT of 76 Gy (ADT + DERT76) versus DERT of 76 Gy alone (DERT76). We performed an analysis based on IRF: clinical stage, prostate-specific antigen level, Gleason score, percentage of positive biopsy cores (PBC) ≥50%, and Gleason pattern. Patients were allocated to 2 groups: favorable intermediate risk (FIR), defined as patients with only 1 IRF without Gleason pattern 4 + 3 or PBC ≥50%; and unfavorable intermediate risk (UIR), defined as all other patients. BF, distant metastases, prostate cancer-specific mortality, OS, and DMFS were compared between FIR and UIR.
RESULTS


The median follow-up was 11.3 years (interquartile range, 10.9-11.7). In the FIR cohort, BF and OS were not significantly different between arms. UIR patients had significantly worse DMFS (hazard ratio [95% confidence interval], 1.61 [1.20-2.15]; P = .026) and OS (1.51 [1.12-2.04]; P = .0495) and a nonsignificant higher cumulative incidence of BF rate (1.55 [0.98-2.47]; P = .08). In UIR patients, a significant improvement in BF was seen in the arms receiving ADT compared to DERT76 alone. On multivariable analysis, Gleason pattern 4 + 3 and prostate-specific antigen >10 ng/mL independently affected BF and OS, regardless of the treatment arm.
CONCLUSIONS


In IRPC, therapeutic optimization appears possible. To avoid ADT side effects, DERT76 alone appears sufficient in patients harboring only 1 risk factor without Gleason pattern 4 + 3 and PBC ≥50% (FIR). All other UIR patients seem to benefit from ADT + DERT76.",2021,In UIR patients a significant improvement in BF was seen in the arms receiving ADT compared to DERT76 alone.,"['600 patients with IRPC to a three-arm trial with 200 patients per arm consisting of 6 months of', 'patients with intermediate risk prostate cancer (IRPC']","['ADT plus RT 70Gy', 'androgen deprivation therapy (ADT) and/or dose escalated radiotherapy (DERT']","['cumulative incidence of BF rate', 'BF, DM, PCSM, OS and DMFS', 'biochemical failure (BF), distant metastases (DM), prostate cancer specific mortality (PCSM), overall survival (OS) and distant metastases-free survival (DMFS) rates', 'BF and OS', 'DMFS [Hazard ratio', 'BF']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",600.0,0.14488,In UIR patients a significant improvement in BF was seen in the arms receiving ADT compared to DERT76 alone.,"[{'ForeName': 'Abdenour', 'Initials': 'A', 'LastName': 'Nabid', 'Affiliation': 'Service de radio-oncologie, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada. Electronic address: abdenour.nabid@usherbrooke.ca.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Carrier', 'Affiliation': 'Centre de recherche clinique, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vigneault', 'Affiliation': 'Centre de radio-oncologie, Centre Hospitalier Universitaire de Québec, Québec, Canada.'}, {'ForeName': 'Thu', 'Initials': 'T', 'LastName': 'Van Nguyen', 'Affiliation': 'Service de radio-oncologie, Centre Hospitalier Universitaire de Montréal, Montréal, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vavassis', 'Affiliation': 'Département de radio-oncologie, Hôpital Maisonneuve-Rosemont de Montréal, Montréal, Canada.'}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Brassard', 'Affiliation': 'Département de radio-oncologie, Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean, Chicoutimi, Canada.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Bahoric', 'Affiliation': 'Service de radio-oncologie, Hôpital Général Juif de Montréal, Montréal, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Archambault', 'Affiliation': 'Département de radio-oncologie, Hôpital de Gatineau, Gatineau, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vincent', 'Affiliation': 'Département de radio-oncologie, Centre Hospitalier Régional de Trois-Rivières, Trois-Rivières, Canada.'}, {'ForeName': 'Redouane', 'Initials': 'R', 'LastName': 'Bettahar', 'Affiliation': 'Service de radio-oncologie, Centre Hospitalier Régional de Rimouski, Rimouski, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wilke', 'Affiliation': 'Department of radiation Oncology, Nova Scotia Cancer Center, Halifax, Canada.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Souhami', 'Affiliation': 'Department of radiation oncology, McGill University Health Centre, Montréal, Canada.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.04.013']
1170,33914595,"Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study.","PURPOSE


The first interim analysis of the phase III, randomized, placebo-controlled TITAN study showed that apalutamide significantly improved overall survival (OS) and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) receiving ongoing androgen deprivation therapy (ADT). Herein, we report final efficacy and safety results after unblinding and placebo-to-apalutamide crossover.
METHODS


Patients with mCSPC (N = 1,052) were randomly assigned 1:1 to receive apalutamide (240 mg QD) or placebo plus ADT. After unblinding in January 2019, placebo-treated patients were allowed to receive apalutamide. Efficacy end points were updated using the Kaplan-Meier method and Cox proportional-hazards model without formal statistical retesting and adjustment for multiplicity. Change from baseline in Functional Assessment of Cancer Therapy-Prostate total score was assessed.
RESULTS


With a median follow-up of 44.0 months, 405 OS events had occurred and 208 placebo-treated patients (39.5%) had crossed over to apalutamide. The median treatment duration was 39.3 (apalutamide), 20.2 (placebo), and 15.4 months (crossover). Compared with placebo, apalutamide plus ADT significantly reduced the risk of death by 35% (median OS not reached  v  52.2 months; hazard ratio, 0.65; 95% CI, 0.53 to 0.79;  P  < .0001) and by 48% after adjustment for crossover (hazard ratio, 0.52; 95% CI, 0.42 to 0.64;  P  < .0001). Apalutamide plus ADT delayed second progression-free survival and castration resistance ( P  < .0001 for both). Health-related quality of life, per total Functional Assessment of Cancer Therapy-Prostate, in both groups was maintained through the study. Safety was consistent with previous reports.
CONCLUSION


The final analysis of TITAN confirmed that, despite crossover, apalutamide plus ADT improved OS, delayed castration resistance, maintained health-related quality of life, and had a consistent safety profile in a broad population of patients with mCSPC.",2021,Apalutamide plus ADT delayed second progression-free survival and castration resistance ( P  < .0001 for both).,"['patients with metastatic castration-sensitive prostate cancer (mCSPC) receiving ongoing', 'Patients with mCSPC (N = 1,052', 'Patients With Metastatic Castration-Sensitive Prostate Cancer']","['placebo, apalutamide plus ADT', 'androgen deprivation therapy (ADT', 'placebo plus ADT', 'placebo', 'Apalutamide', 'apalutamide']","['median treatment duration', 'overall survival (OS) and radiographic progression-free survival', 'risk of death', 'OS, delayed castration resistance, maintained health-related quality of life', 'Functional Assessment of Cancer Therapy-Prostate total score', 'Apalutamide plus ADT delayed second progression-free survival and castration resistance', 'Health-related quality of life, per total Functional Assessment of Cancer Therapy-Prostate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",1052.0,0.556457,Apalutamide plus ADT delayed second progression-free survival and castration resistance ( P  < .0001 for both).,"[{'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer and Vancouver Prostate Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Guy's and St Thomas' Hospitals, London, United Kingdom.""}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Bjartell', 'Affiliation': 'Skåne University Hospital, Lund University, Malmö, Sweden.'}, {'ForeName': 'Byung Ha', 'Initials': 'BH', 'LastName': 'Chung', 'Affiliation': 'Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Pereira de Santana Gomes', 'Affiliation': 'Liga Norte Riograndense Contra O Cancer, Natal, Brazil.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Given', 'Affiliation': 'Urology of Virginia, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Juárez', 'Affiliation': 'Hospital Universitario de Jerez de la Frontera, Cadiz, Spain.'}, {'ForeName': 'Axel S', 'Initials': 'AS', 'LastName': 'Merseburger', 'Affiliation': 'University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Kindai University Hospital Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Brookman-May', 'Affiliation': 'Ludwig-Maximilians-University (LMU), Munich, Germany.'}, {'ForeName': 'Suneel D', 'Initials': 'SD', 'LastName': 'Mundle', 'Affiliation': 'Janssen Research & Development, Spring House, PA.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'McCarthy', 'Affiliation': 'Janssen Research & Development, Spring House, PA.'}, {'ForeName': 'Julie S', 'Initials': 'JS', 'LastName': 'Larsen', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Bevans', 'Affiliation': 'Janssen Research & Development, Horsham, PA.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, San Diego, CA.'}, {'ForeName': 'Nibedita', 'Initials': 'N', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Janssen Research & Development, Spring House, PA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.03488']
1171,33938149,Comparative clinical outcomes of insulin degludec and insulin glargine 300 U/mL after switching from other basal insulins in real-world patients with type 1 and type 2 diabetes.,"AIMS/INTRODUCTION


To evaluate and compare the efficacy of insulin degludec (IDeg) and insulin glargine 300 U/mL (Gla300) 6 months after switching from other basal insulins by assessing the changes in glycated hemoglobin (HbA1c), body mass index (BMI), and insulin doses in patients with type 1 and type 2 diabetes in a real-world clinical setting.
MATERIALS AND METHODS


A total of 307 patients with type 1 diabetes and 294 patients with type 2 diabetes with HbA1c >7.0% were studied. Adjusted mean changes in HbA1c, BMI, and insulin doses were compared between IDeg (IDeg group) and Gla300 (Gla300 group) switchers. Multivariable logistic regression analyses were carried out to examine whether the IDeg or Gla300 group was associated with HbA1c or insulin dose reduction and BMI gain.
RESULTS


HbA1c was significantly decreased in both the IDeg and Gla300 groups. Adjusted mean changes in HbA1c (approximately -0.3% and -0.5% in type 1 diabetes and type 2 diabetes patients, respectively) and BMI were similar between both groups. The mean change in insulin dose was slightly larger for dose reduction in the IDeg group than in the Gla300 group. Multivariable logistic regression models showed that the IDeg group was significantly associated with insulin dose reduction after adjusting for basal insulin type, insulin dose, and number of basal insulin injections at baseline and other confounding factors.
CONCLUSIONS


The current study suggested that IDeg and Gla300 have similar effects in reducing HbA1c and gaining BMI after switching from other basal insulins in Japanese patients with type 1 diabetes and type 2 diabetes. IDeg selection was associated with insulin dose reduction.",2021,The mean change in insulin dose was slightly larger for dose reduction in the IDeg group than in the Gla300 group.,"['307 patients with type\xa01 diabetes and 294 patients with type\xa02 diabetes with HbA1c >7.0% were studied', 'Japanese patients with type\xa01 diabetes and type 2 diabetes']","['insulin degludec (IDeg) and insulin glargine 300\xa0U/mL (Gla300', 'insulin degludec and insulin glargine 300']","['glycated hemoglobin (HbA1c), body mass index (BMI), and insulin doses', 'BMI', 'mean change in insulin dose', 'HbA1c, BMI, and insulin doses', 'HbA1c and gaining BMI', 'HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2959938', 'cui_str': 'Change in insulin dose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",307.0,0.0837426,The mean change in insulin dose was slightly larger for dose reduction in the IDeg group than in the Gla300 group.,"[{'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Oya', 'Affiliation': ""Diabetes Center, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Nakagami', 'Affiliation': ""Diabetes Center, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': ""Diabetes Center, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Katamine', 'Affiliation': ""Diabetes Center, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': ""Diabetes Center, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Babazono', 'Affiliation': ""Diabetes Center, Tokyo Women's Medical University, Tokyo, Japan.""}]",Journal of diabetes investigation,['10.1111/jdi.13559']
1172,33942566,"Single- and Multiple-Dose Pharmacokinetics and Pharmacodynamics of PN-943, a Gastrointestinal-Restricted Oral Peptide Antagonist of α4β7, in Healthy Volunteers.","PN-943 is an orally stable, gastrointestinal-restricted peptide that binds specifically to α4ß7 integrin on leukocytes, blocking leukocyte trafficking to and activation in the gut, inhibiting colon inflammation and reducing signs and symptoms of active ulcerative colitis. Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers. Study 1 was a first-in-human study with 40 male subjects receiving PN-943, 100 to 1400 mg or placebo, as single doses and 57 male subjects receiving PN-943, 100 to 1000 mg or placebo, as multiple doses. Study 2 was a randomized, crossover study comparing multiple doses of 450-mg PN-943 twice daily as a liquid solution and as an immediate-release tablet in 10 subjects. No subjects discontinued due to treatment-emergent adverse events. Consistent with the gastrointestinal-restricted nature of the peptide, systemic exposure was minimal; there was an approximate dose-proportional increase in area under the plasma concentration-time curve. There was minimal accumulation with once-daily dosing and an absence of time-dependent changes in pharmacokinetics. Administration of PN-943 after a high-fat meal reduced peak plasma concentration and area under the plasma concentration-time curve. There was minimal (<0.1%) urinary excretion of intact drug, and there was a dose-related increase in fecal excretion of intact PN-943. Dose-dependent increases in blood receptor occupancy and reduction in blood receptor expression were observed, supporting target engagement. Twice-daily dosing resulted in sustained receptor occupancy with low plasma fluctuations (143%). PN-943 was generally well tolerated following single and multiple oral doses with low systemic exposure. Twice-daily dosing resulted in sustained pharmacokinetics and pharmacodynamics, supporting further investigation in efficacy studies.",2021,"PN-943 is an orally stable, gastrointestinal-restricted peptide that binds specifically to α4ß7 integrin on leukocytes, blocking leukocyte trafficking to and activation in the gut, inhibiting colon inflammation and reducing signs and symptoms of active ulcerative colitis.","['Healthy Volunteers', '10 subjects', '40 male subjects receiving', ' as single doses and 57 male subjects receiving', 'healthy volunteers']","['450-mg PN-943', 'PN-943', 'PN-943, 100 to 1000 mg or placebo', 'PN-943, 100 to 1400\xa0mg or placebo']","['blood receptor occupancy', 'fecal excretion of intact PN-943', 'blood receptor expression', 'peak plasma concentration and area under the plasma concentration-time curve', 'urinary excretion of intact drug']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",40.0,0.0621377,"PN-943 is an orally stable, gastrointestinal-restricted peptide that binds specifically to α4ß7 integrin on leukocytes, blocking leukocyte trafficking to and activation in the gut, inhibiting colon inflammation and reducing signs and symptoms of active ulcerative colitis.","[{'ForeName': 'Nishit B', 'Initials': 'NB', 'LastName': 'Modi', 'Affiliation': 'Protagonist Therapeutics, Inc, Newark, California, USA.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Protagonist Therapeutics, Inc, Newark, California, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Mattheakis', 'Affiliation': 'Protagonist Therapeutics, Inc, Newark, California, USA.'}, {'ForeName': 'Ching-Chang', 'Initials': 'CC', 'LastName': 'Hwang', 'Affiliation': 'Protagonist Therapeutics, Inc, Newark, California, USA.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Nawabi', 'Affiliation': 'Protagonist Therapeutics, Inc, Newark, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Protagonist Therapeutics, Inc, Newark, California, USA.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Protagonist Therapeutics, Inc, Newark, California, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.946']
1173,33892048,"Hyperosmolar Eye Drops for Diurnal Corneal Edema in Fuchs' Endothelial Dystrophy: A Double-Masked, Randomized Controlled Trial.","PURPOSE


The Eye Drops for Early Morning-Associated Swelling (EDEMAS) trial assessed the efficacy of hyperosmolar eye drops on corneal edema resolution.
DESIGN


Double-masked, randomized controlled trial of hyperosmolar eye drops.
PARTICIPANTS


Participants with Fuchs' dystrophy scheduled for Descemet membrane endothelial keratoplasty.
METHODS


One eye was randomized to hyperosmolar eye drops (treatment); the fellow eye was randomized to artificial tears (placebo). After baseline examination in the afternoon, corneas were examined using Scheimpflug tomography after eye opening in the morning. Participants received eye drops twice. Imaging was repeated every 30 minutes up to 4 hours.
MAIN OUTCOME MEASURES


Decrease in central corneal thickness 1 hour after eye opening (primary end point), corneal thickness, subjective visual function, glare, visual acuity, and adverse events (AEs) (secondary end points).
RESULTS


A total of 68 participants received the allocated intervention (59 eyes received treatment; 55 eyes received placebo). All eyes had stromal edema; none had epithelial edema. Corneal thickness was 626 μm in the treatment arm and 622 μm in the placebo arm after eye opening, indicating an early morning edema compared with baseline of +21 μm and +24 μm, respectively. Decrease in corneal thickness after 1 hour was -10.5 μm in the treatment arm (95% confidence interval [CI], -12.8 to -8.2) and -11.2 μm (95% CI, -13.6 to -8.9) in the placebo arm (between-arm difference, 0.7 μm, 95% CI, -2.0 to 3.5; P = 0.59), indicating no clinically relevant effect of hyperosmolar eye drops on early morning corneal edema. Results were not compatible with a relevant treatment effect on corneal thickness, visual acuity, and glare over the entire course of the study. Increase in subjective visual function was less rapid in the treatment arm than in the placebo arm. Adverse events, most commonly burning after eye drop application, were more common with treatment (30 eyes) than placebo (1 eye; risk difference, 49 percentage points; 95% CI, 36-62).
CONCLUSIONS


In this double-masked, randomized controlled trial, resolution of early morning stromal edema was not accelerated by hyperosmolar eye drops, which more frequently caused AEs. These results are not compatible with a clinically relevant effect of hyperosmolar eye drops and do not support their routine use.",2021,"Corneal thickness was 626 μm in the treatment arm and 622 μm in the placebo arm after eye opening, indicating an early-morning edema compared to baseline of +21 μm and +24 μm, respectively.","[""Fuchs' endothelial dystrophy"", ""Participants with Fuchs' dystrophy scheduled for Descemet membrane endothelial keratoplasty"", '68 participants received the']","['Hyperosmolar eye drops', 'hyperosmolar eye drops', 'hyperosmolar eye drops (treatment); the fellow eye was randomized to artificial tears (placebo', 'hyperosmolar eye drops vs. placebo', 'placebo', 'allocated intervention (59 eyes treatment, 55 eyes placebo']","['subjective visual function', 'epithelial edema', 'Adverse events', 'corneal thickness', 'central corneal thickness one hour after eye opening (primary endpoint); corneal thickness, subjective visual function, glare, visual acuity, and adverse events (secondary endpoints', 'corneal thickness, visual acuity, and glare', 'diurnal corneal edema', 'Corneal thickness']","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0026850', 'cui_str': 'Muscular dystrophy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}]","[{'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0278215', 'cui_str': 'Glare'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}]",,0.690929,"Corneal thickness was 626 μm in the treatment arm and 622 μm in the placebo arm after eye opening, indicating an early-morning edema compared to baseline of +21 μm and +24 μm, respectively.","[{'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Zander', 'Affiliation': 'Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Böhringer', 'Affiliation': 'Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Fritz', 'Affiliation': 'Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Grewing', 'Affiliation': 'Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Maier', 'Affiliation': 'Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Thabo', 'Initials': 'T', 'LastName': 'Lapp', 'Affiliation': 'Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Reinhard', 'Affiliation': 'Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Wacker', 'Affiliation': 'Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: katrin.wacker@uniklinik-freiburg.de.'}]",Ophthalmology,['10.1016/j.ophtha.2021.04.015']
1174,33892046,Effect of Corneal Cross-linking versus Standard Care on Keratoconus Progression in Young Patients: The KERALINK Randomized Controlled Trial.,"PURPOSE


To examine the efficacy and safety of corneal cross-linking (CXL) for stabilization of progressive keratoconus.
DESIGN


Observer-masked, randomized, controlled, parallel-group superiority trial.
PARTICIPANTS


Sixty participants 10 to 16 years of age with progressive keratoconus, one eye of each deemed the study eye.
METHODS


The study eye was randomized to either CXL plus standard care or standard care alone, with spectacle or contact lens correction as necessary for vision.
MAIN OUTCOME MEASURES


The primary outcome was steep keratometry (K2) in the study eye as a measure of the steepness of the cornea at 18 months. Secondary outcomes included keratoconus progression defined as a 1.5-diopter (D) increase in K2, visual acuity, keratoconus apex corneal thickness, and quality of life.
RESULTS


Of 60 participants, 30 were randomized to CXL and standard care groups. Of these, 30 patients in the CXL group and 28 patients in the standard care group were analyzed. Mean K2 in the study eye 18 months after randomization was 49.7 D (standard deviation [SD], 3.8 D) in the CXL group and 53.4 D (SD, 5.8 D) in the standard care group. The adjusted mean difference in K2 in the study eye was -3.0 D (95% confidence interval [CI], -4.9 to -1.1 D; P = 0.002), favoring CXL. Adjusted differences between groups in uncorrected and corrected vision favored eyes receiving CXL: -0.31 logarithm of the minimum angle of resolution (logMAR; 95% CI, -0.50 to -0.11 logMAR; P = 0.002) and -0.51 logMAR (95% CI, -1.37 to 0.35 logMAR; P = 0.002). Keratoconus progression in the study eye occurred in 2 patients (7%) randomized to CXL compared with 12 patients (43%) randomized to standard care. The unadjusted odds ratio suggests that on average, patients in the CXL arm had 90% (odds ratio, 0.1; 95% CI, 0.02-0.48; P = 0.004) lower odds of experiencing progression compared with those receiving standard care.
CONCLUSIONS


CXL arrests progression of keratoconus in the majority of young patients. CXL should be considered as a first-line treatment in progressive disease. If the arrest of keratoconus progression induced by CXL is sustained in longer follow-up, particular benefit may be derived from avoiding a later requirement for contact lens wear or corneal transplantation.",2021,Keratoconus progression in the study eye occurred in 2 patients (7%) randomized to CXL compared to 12 (43%) randomized to standard care.,"['60 participants, 30 were randomized to', 'young patients', ' 60 participants aged 10-16 years with progressive keratoconus', '30 patients in the CXL group and 28 patients in the standard care group were analyzed']","['CXL', 'CXL plus standard care or standard care alone, with spectacle or contact lens correction as necessary for vision', 'corneal cross linking (CXL']","['Quality of life outcomes', 'keratoconus progression defined as 1.5 dioptres (D) increase in K2, visual acuity, keratoconus apex corneal thickness and quality of life', 'logMAR vision', 'K2 in the study eye as a measure of the steepness of the cornea', 'Keratoconus progression', 'unadjusted odds ratio (OR', 'mean (SD) K2']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C4728129', 'cui_str': 'Corneal cross linking'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.330318,Keratoconus progression in the study eye occurred in 2 patients (7%) randomized to CXL compared to 12 (43%) randomized to standard care.,"[{'ForeName': 'Daniel F P', 'Initials': 'DFP', 'LastName': 'Larkin', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom. Electronic address: f.larkin@ucl.ac.uk.'}, {'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Burr', 'Affiliation': 'School of Medicine, University of St. Andrews, St. Andrews, United Kingdom.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Raynor', 'Affiliation': 'Department of Ophthalmology, Royal Hallamshire Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Edwards', 'Affiliation': 'Department of Ophthalmology, Royal Hallamshire Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Tuft', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Caverly', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2021.04.019']
1175,33894800,Changes in Dependence as Smokers Switch from Cigarettes to JUUL in Two Nicotine Concentrations.,"Objectives:  In this study, we assessed changes in dependence as smokers transitioned from cigarette smoking to exclusive use of the JUUL System (""JUUL""), contrasting users of 5.0% versus 3.0% nicotine concentration pods.  Methods:  Overall, 5246 adult (age ≥ 21) established smokers (> 100 cigarettes lifetime) who purchased a JUUL device completed online surveys at baseline, when smoking, and one and 3 months later; 1758 reported no past-30-day smoking ('switching') at one or both timepoints. Analyses compared dependence on cigarettes (at baseline) and JUUL (at follow-up), as assessed by the 4-item PROMIS scale (Range: 0-4).  Results:  Switching increased from Month 1 (18.3%) to Month 3 (28.6%); switchers at one month (Difference = 0.23) and 3 months (0.24) showed lower mean baseline cigarette dependence. Dependence decreased significantly (p s  < .001) from baseline cigarette dependence to JUUL dependence at both one (from 1.82 to 1.59) and 3 months (1.97 to 1.73); changes did not significantly differ between users of 5.0% and 3.0% (p s  > .43). Dependence on JUUL did not change significantly from Month 1 to Month 3.  Conclusions:  Dependence decreased as smokers transitioned from smoking to exclusive use of JUUL, similarly for users of both nicotine concentrations. Smokers who switch to JUUL may reduce their nicotine dependence.",2021,Switching increased from Month 1 (18.3%) to Month 3 (28.6%); switchers at one month (Difference = 0.23) and 3 months (0.24) showed lower mean baseline cigarette dependence.,"[""5246 adult (age ≥ 21) established smokers (> 100 cigarettes lifetime) who purchased a JUUL device completed online surveys at baseline, when smoking, and one and 3 months later; 1758 reported no past-30-day smoking ('switching') at one or both timepoints""]",[],['Dependence'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}]",5246.0,0.119749,Switching increased from Month 1 (18.3%) to Month 3 (28.6%); switchers at one month (Difference = 0.23) and 3 months (0.24) showed lower mean baseline cigarette dependence.,"[{'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Shiffman', 'Affiliation': 'Senior Scientific Advisor, PinneyAssociates Inc, Pittsburgh, PA, United States.'}, {'ForeName': 'Nicholas I', 'Initials': 'NI', 'LastName': 'Goldenson', 'Affiliation': 'Behavioral Scientist, Juul Labs Inc, Washington, DC, United States.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Hatcher', 'Affiliation': 'Behavioral Science Research Associate, Juul Labs Inc, Washington, DC, United States.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'Augustson', 'Affiliation': 'Senior Director, Behavioral Affairs, Juul Labs Inc, Washington, DC, United States.'}]",American journal of health behavior,['10.5993/AJHB.45.3.10']
1176,33928660,Assessing vaccine durability in randomized trials following placebo crossover.,"Randomized vaccine trials are used to assess vaccine efficacy (VE) and to characterize the durability of vaccine-induced protection. If efficacy is demonstrated, the treatment of placebo volunteers becomes an issue. For COVID-19 vaccine trials, there is broad consensus that placebo volunteers should be offered a vaccine once efficacy has been established. This will likely lead to most placebo volunteers crossing over to the vaccine arm, thus complicating the assessment of long term durability. We show how to analyze durability following placebo crossover and demonstrate that the VE profile that would be observed in a placebo controlled trial is recoverable in a trial with placebo crossover. This result holds no matter when the crossover occurs and with no assumptions about the form of the efficacy profile. We only require that the VE profile applies to the newly vaccinated irrespective of the timing of vaccination. We develop different methods to estimate efficacy within the context of a proportional hazards regression model and explore via simulation the implications of placebo crossover for estimation of VE under different efficacy dynamics and study designs. We apply our methods to simulated COVID-19 vaccine trials with durable and waning VE and a total follow-up of 2 years.",2021,This result holds no matter when the crossover occurs and with no assumptions about the form of the efficacy profile.,[],['placebo'],['vaccine efficacy (VE'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.504492,This result holds no matter when the crossover occurs and with no assumptions about the form of the efficacy profile.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fintzi', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, 5601, Maryland, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Follmann', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, 5601, Maryland, USA.'}]",Statistics in medicine,['10.1002/sim.9001']
1177,33926591,PROTECT: a novel psychotherapy for late-life depression in elder abuse victims.,"Elder abuse is prevalent, and victims have high rates of depression and low quality of life. We established an academic-community partnership to test the feasibility, acceptability, and impact of a brief psychotherapy for depression (PROTECT) among elder abuse victims with capacity to make decisions. Elder abuse service providers referred depressed (Patient Health Questionnaire-9 [PHQ-9] ≥ 10) older victims (age ≥ 55 years) for potential pilot study participation. Forty eligible victims who consented were randomized to PROTECT psychotherapy (N = 25) or a Usual Care (N = 15) condition involving a community psychotherapy referral. Follow-up research assessments were conducted at 6 weeks (mid-treatment) and 9 weeks (end of treatment) after study initial assessment. We used mixed-effects regression models to examine treatment effects on depression severity and quality of life over time. Most victims (75%) reported two or more types of abuse. The a priori acceptability benchmark was met at the end of PROTECT therapy. All PROTECT participants initiated therapy; this engagement rate is greater than the a priori 75% standard set for feasibility. We found a significant reduction in depression severity (Montgomery-Åsberg Depression Rating Scale [MADRS]), with PROTECT leading to greater benefits compared to Usual Care. Both study groups had a similar improvement in quality of life. The pilot project results found that PROTECT psychotherapy is feasible, acceptable, and effective in reducing depression. With the support of our partnership, we found that PROTECT could be delivered alongside elder abuse services with victims willing to initiate therapy that leads to meaningful treatment effects.",2021,Both study groups had a similar improvement in quality of life.,"['elder abuse victims', 'Forty eligible victims who consented', 'late-life depression in elder abuse victims', '10) older victims (age ≥ 55 years', 'Elder abuse service providers referred depressed (Patient Health Questionnaire-9']","['psychotherapy', 'novel psychotherapy', 'Usual Care (N = 15) condition involving a community psychotherapy referral']","['depression severity (Montgomery-Åsberg Depression Rating Scale [MADRS', 'quality of life', 'depression severity and quality of life over time']","[{'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013772', 'cui_str': 'Elderly person maltreatment'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0296859,Both study groups had a similar improvement in quality of life.,"[{'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, White Plains, NY10605, USA.'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, White Plains, NY10605, USA.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Guillod', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, White Plains, NY10605, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zanotti', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, White Plains, NY10605, USA.'}, {'ForeName': 'Jihui', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, White Plains, New York, NY10605, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Soliman', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, White Plains, NY10605, USA.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, White Plains, NY10605, USA.'}]",International psychogeriatrics,['10.1017/S1041610221000430']
1178,33930663,Feasibility and promise of community providers implementing home-based parent-child interaction therapy for families investigated for child abuse: A pilot randomized controlled trial.,"BACKGROUND


Despite evidence supporting Parent-Child Interaction Therapy's (PCIT) effectiveness for maltreatment prevention, its integration in child welfare services (CWS) has been challenging.
OBJECTIVE


Using a pilot randomized controlled trial design, we evaluated the (1) feasibility of training therapists from CWS providers to implement home-based PCIT (2) feasibility of retaining parent-child dyads at-risk for child abuse in voluntary PCIT services, and (3) promise of PCIT for improving parenting skills.
PARTICIPANTS AND SETTING


Between 2015-2017, 23 therapists from CWS providers and 55 caregiver-child dyads who were determined to be at moderate-to-high risk for physical and/or emotional abuse, remained in the same home, and were referred for voluntary parenting services following a child protective investigation participated.
METHODS


We trained 14 therapists in home-based PCIT and randomly assigned participating dyads to receive PCIT or services as usual (SAU). Dyads completed baseline and post-treatment assessments, including self-reported and observed parenting skills.
RESULTS


All therapists successfully completed the PCIT training; none completed full certification requirements. Of all randomized dyads, 51 % completed at least one treatment session, and the mean number of treatment sessions was 10.83. Caregivers assigned to PCIT used more self-reported (d = .72) and observed (d = .59) positive parenting skills post-treatment than caregivers assigned to SAU. Negative, inconsistent, and punitive parenting strategies and parenting stress did not significantly differ between caregivers assigned to PCIT and SAU.
CONCLUSIONS


Despite several challenges to feasibly implementing PCIT in community-based child welfare settings, even a small dose of PCIT improved positive parenting skills among at-risk parent-child dyads.",2021,Caregivers assigned to PCIT used more self-reported (d = .72) and observed (d = .59) positive parenting skills post-treatment than caregivers assigned to SAU.,"['families investigated for child abuse', 'Between 2015-2017, 23 therapists from CWS providers and 55 caregiver-child dyads who were determined to be at moderate-to-high risk for physical and/or emotional abuse, remained in the same home, and were referred for voluntary parenting services following a child protective investigation participated', 'child welfare services (CWS']","['PCIT', 'community providers implementing home-based parent-child interaction therapy', 'PCIT or services as usual (SAU']","['self-reported and observed parenting skills', 'positive parenting skills', 'punitive parenting strategies and parenting stress']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0730557', 'cui_str': 'Emotional abuse'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]","[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.132651,Caregivers assigned to PCIT used more self-reported (d = .72) and observed (d = .59) positive parenting skills post-treatment than caregivers assigned to SAU.,"[{'ForeName': 'Miguel T', 'Initials': 'MT', 'LastName': 'Villodas', 'Affiliation': 'Department of Psychology, San Diego State University, United States; Department of Psychology, Florida International University, United States; Department of Psychology, University of Utah, United States. Electronic address: mvillodas@sdsu.edu.'}, {'ForeName': 'Jacqueline O', 'Initials': 'JO', 'LastName': 'Moses', 'Affiliation': 'Department of Psychology, Florida International University, United States.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Cromer', 'Affiliation': 'Department of Psychology, Florida International University, United States.'}, {'ForeName': 'Lucybel', 'Initials': 'L', 'LastName': 'Mendez', 'Affiliation': 'Center for Children and Families, Florida International University, United States.'}, {'ForeName': 'Loreen S', 'Initials': 'LS', 'LastName': 'Magariño', 'Affiliation': 'Department of Psychology, Florida International University, United States.'}, {'ForeName': 'Feion M', 'Initials': 'FM', 'LastName': 'Villodas', 'Affiliation': 'Department of Psychology, San Diego State University, United States; Department of Psychology, Florida International University, United States; Department of Psychology, University of Utah, United States.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Bagner', 'Affiliation': 'Department of Psychology, Florida International University, United States; Department of Psychology, University of Utah, United States.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.105063']
1179,34388515,Patient-reported outcomes in a phase II randomised study of regorafenib compared with lomustine in patients with relapsed glioblastoma (the REGOMA trial).,"BACKGROUND


The REGOMA trial showed that regorafenib significantly improved overall survival in patients with recurrent glioblastoma compared with lomustine. Patients treated with regorafenib experienced a higher occurrence of grade 3-4 drug-related adverse events than those receiving the standard treatment. Because this safety profile was expected, it was considered of great importance to assess the patient point of view regarding the disease and treatment impact on different aspects of life and patient well-being. We here report the final results of the health-related quality of life (HRQoL) assessment, a secondary end-point of the study. This trial is registered with ClinicalTrials.gov, NCT02926222.
METHODS


Patient-reported outcomes were assessed, within a prospective, randomised, multicentre, open-label phase II trial, by the European Organisation for Research and Treatment of Cancer core questionnaire and brain module at baseline and every 8-weekly neuroradiological assessment till disease progression. Mixed-effect linear models were fitted for each of the HRQoL domain to examine the change over progression-free time within and between arms. Furthermore, differences were also classified as clinically meaningful changes. To correct for multiple comparisons and avoid type I errors, the level of significance was set at P = 0.01 (2-sided).
RESULTS


Of 119 enrolled patients, 56/59 (95%) patients and 58/60 (97%) patients treated with regorafenib and lomustime completed questionnaires at baseline, respectively. No significant differences were observed in any generic or cancer-specific domain during treatment in both arms, or between the two arms, except for the appetite loss and diarrhoea scales which were significantly worse in patients treated with regorafenib. The rate of patients with a clinically meaningful worsening for appetite loss, diarrhoea and for any other domain was not statistically different between the two arms.
CONCLUSIONS


Regorafenib did not negatively affect HRQoL in patients with recurrent glioblastoma. These data combined with the survival benefit shown in the REGOMA trial support the use of regorafenib as a treatment option for these patients.",2021,"No significant differences were observed in any generic or cancer-specific domain during treatment in both arms, or between the two arms, except for the appetite loss and diarrhoea scales which were significantly worse in patients treated with regorafenib.","['patients with recurrent glioblastoma', 'Of 119 enrolled patients, 56/59 (95%) patients and 58/60 (97', 'patients with relapsed glioblastoma (the REGOMA trial']","['Regorafenib', 'regorafenib', 'lomustine']","['overall survival', 'higher occurrence of grade 3-4 drug-related adverse events', 'generic or cancer-specific domain', 'appetite loss and diarrhoea scales', 'appetite loss, diarrhoea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",119.0,0.204682,"No significant differences were observed in any generic or cancer-specific domain during treatment in both arms, or between the two arms, except for the appetite loss and diarrhoea scales which were significantly worse in patients treated with regorafenib.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lombardi', 'Affiliation': 'Department of Oncology, Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Del Bianco', 'Affiliation': 'Clinical Research Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Medical Oncology Department, AUSL/IRCCS, Neurological Science Institute, Bologna, Italy.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Eoli', 'Affiliation': 'Molecolar Neuro-Oncology Unit, IRCCS Foundation, ""Carlo Besta"" Neurological Institute, Milan, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Rudà', 'Affiliation': 'Department of Neuro-Oncology, University of Turin and City of Health and Science Hospital, Turin, Italy.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'Osteoncology and Rare Tumors Center, IRST-IRCCS ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Lolli', 'Affiliation': 'Medical Oncology Unit, IRCCS Saverio de Bellis Hospital, Castellana Grotte, Bari, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rizzato', 'Affiliation': 'Department of Oncology, Santa Maria della Misericordia University Hospital, Udine, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Oncology Unit, Ospedale del Mare, Napoli, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pace', 'Affiliation': 'Neuroncology Unit, IRCCS Regina Elena Cancer Institute, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pasqualetti', 'Affiliation': 'Radiotherapy Unit, University Hospital S. Chiara, Pisa, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Caccesse', 'Affiliation': 'Department of Oncology, Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Bergo', 'Affiliation': 'Department of Oncology, Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Magni', 'Affiliation': 'Clinical Research Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'De Salvo', 'Affiliation': 'Clinical Research Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. Electronic address: gianluca.desalvo@iov.veneto.it.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Department of Oncology, Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.06.055']
1180,33927696,Step-Down of FSH- Dosage During Ovarian Stimulation - Basic Lessons to Be Learnt From a Randomized Controlled Trial.,"A rise in serum progesterone in the late follicular phase is a well described adverse effect of ovarian stimulation for IVF/ICSI. Previous data suggest, that enhanced gonadotropin stimulation causes progesterone elevation and the incidence of premature progesterone elevation can be reduced by declining gonadotropin dosages. This randomized controlled trial (RCT) aimed to achieve a significant reduction of the progesterone level on the day of final oocyte maturation by a daily reduction of 12.5 IU rec-FSH from a follicle size of 14 mm in a GnRH-antagonist protocol. A total of 127 patients had been recruited (Control group (CG): 62 patients; Study group (SG): 65 patients). Due to drop out, data from 108 patients (CG: 55 patients; SG: 53 patients) were included into the analysis. Patients' basic parameters, gonadotropin (Gn)-starting dose, total Gn-stimulation dosage, the number of retrieved and mature oocytes as well as in the hormonal parameters on the day of trigger (DoT) were not statistically significantly different. However, through stepwise Gn-reduction of 12.5 IU/day in the SG, there was a statistically highly significant difference in the Gn-stimulation dosage on the day of trigger (p < 0.0001) and statistically significant associations for the DoT-P4-levels with the DoT-FSH-levels for both groups (CG: p = 0.001; SG: p = 0.0045). The herein described significant associations between DoT-P4-levels and DoT-FSH-levels confirm the theory that enhanced FSH stimulation is the primary source of progesterone elevation on the day of final oocyte maturation in stimulated IVF/ICSI cycles. Given the pathophysiologic mechanism of progesterone elevation during ovarian stimulation, the use of an increased FSH step-down dosage should be studied in future RCTs, despite the fact that a step-down approach of daily 12.5 IU rec-FSH did not achieve a significantly reduced progesterone level on the DoT.  Clinical Trial Registration:  clinicaltrials.gov, identifier NCT03356964.",2021,A rise in serum progesterone in the late follicular phase is a well described adverse effect of ovarian stimulation for IVF/ICSI.,"['108 patients (CG: 55 patients; SG: 53 patients) were included into the analysis', '127 patients had been recruited (Control group (CG): 62 patients; Study group (SG): 65 patients']",[],"['premature progesterone elevation', 'serum progesterone', 'progesterone level']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}]",127.0,0.130713,A rise in serum progesterone in the late follicular phase is a well described adverse effect of ovarian stimulation for IVF/ICSI.,"[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lawrenz', 'Affiliation': 'In-Vitro-Fertilisation (IVF) Department, ART Fertility Clinics, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Coughlan', 'Affiliation': 'In-Vitro-Fertilisation (IVF) Department, ART Fertility Clinics, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Melado', 'Affiliation': 'In-Vitro-Fertilisation (IVF) Department, ART Fertility Clinics, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Shieryl', 'Initials': 'S', 'LastName': 'Digma', 'Affiliation': 'In-Vitro-Fertilisation (IVF) Department, ART Fertility Clinics, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Junard', 'Initials': 'J', 'LastName': 'Sibal', 'Affiliation': 'Clinical Laboratory, ART Fertility Clinics, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Alliza', 'Initials': 'A', 'LastName': 'Jean', 'Affiliation': 'Clinical Laboratory, ART Fertility Clinics, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Human M', 'Initials': 'HM', 'LastName': 'Fatemi', 'Affiliation': 'In-Vitro-Fertilisation (IVF) Department, ART Fertility Clinics, Abu Dhabi, United Arab Emirates.'}]",Frontiers in endocrinology,['10.3389/fendo.2021.661707']
1181,33932360,Sensitivity to Change and Responsiveness of the Original and the Shortened Version of the Community Balance and Mobility Scale for Young Seniors.,"OBJECTIVE


To examine sensitivity to change and responsiveness of the Community Balance and Mobility Scale (CBM) and shortened CBM (s-CBM).
DESIGN


Secondary analysis using data of a randomized controlled trial.
SETTING


General community.
PARTICIPANTS


Young community-dwelling seniors aged 61-70 years (N=134; mean age, 66.2±2.5y).
INTERVENTIONS


Participants underwent 12 months of exercise intervention.
MAIN OUTCOME MEASURES


CBM and s-CBM. Sensitivity to change was assessed using standardized response mean (SRM) and paired t tests as appropriate. Responsiveness was assessed using 2 minimal important difference (MID) estimates. Analyses were conducted for the full sample and for the subgroups ""high-balance"" and ""low-balance,"" divided by median split.
RESULTS


Inferential statistics revealed a significant CBM (P<.001) and s-CBM (P<.001) improvement within the full sample and the subgroups (high-balance: P=.001, P=.019; low-balance: P<.001, P<.001). CBM and s-CBM were moderately sensitive to change (SRM, 0.48 vs 0.38) within the full sample. In the high-balance subgroup, moderate SRM values (0.70) were found for the CBM and small values for the s-CBM (0.29). In the low-balance subgroup, moderate SRM values were found for the CBM (0.67) and high values for the s-CBM (0.80). For the full sample, CBM and s-CBM exceeded the lower but not the higher MID value. In the high-balance subgroup, the CBM exceeded both MID values, but the s-CBM exceeded only the lower. In the low-balance subgroup, CBM and s-CBM exceeded both MID values.
CONCLUSIONS


The CBM is a suitable tool to detect intervention-related changes of balance and mobility in young, high-performing seniors. Both versions of the CBM scale show good sensitivity to change and responsiveness, particularly in young seniors with low balance.",2021,"The CBM is a suitable tool to detect intervention-related changes of balance and mobility in young, high-performing seniors.","['Young community-dwelling seniors (n=155, 66.2±2.5) were recruited', ' Community-dwelling seniors aged 61-70 years INTERVENTION', 'Young Seniors', 'young seniors with low-balance']",[],"['moderate SRM values', 'Community Balance & Mobility Scale (CBM', 'CBM and s-CBM']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0916431,"The CBM is a suitable tool to detect intervention-related changes of balance and mobility in young, high-performing seniors.","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Gordt', 'Affiliation': 'Institute of Sports and Sports Sciences, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Nerz', 'Affiliation': 'Department of Clinical Gerontology, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'A Stefanie', 'Initials': 'AS', 'LastName': 'Mikolaizak', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Taraldsen', 'Affiliation': 'Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology Trondheim, Trondheim, Norway.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Pijnappels', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, the Netherlands.'}, {'ForeName': 'Jorunn L', 'Initials': 'JL', 'LastName': 'Helbostad', 'Affiliation': 'Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology Trondheim, Trondheim, Norway.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Vereijken', 'Affiliation': 'Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology Trondheim, Trondheim, Norway.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Department of Clinical Gerontology, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwenk', 'Affiliation': 'Network Aging Research (NAR), Heidelberg University, Heidelberg, Germany. Electronic address: schwenk@nar.uni-heidelberg.de.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.03.036']
1182,33926921,Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab: nationwide observational study emulating a randomised clinical trial.,"OBJECTIVES


In 2018, a nationwide mandatory switch from originator to biosimilar adalimumab was conducted in Denmark. The available biosimilar was GP2017 (Hyrimoz) in Eastern regions and SB5 (Imraldi) in Western regions. We aimed to assess the comparative effectiveness of GP2017 versus SB5 in patients with rheumatoid arthritis (RA)/psoriatic arthritis (PsA)/axial spondyloarthritis (AxSpA).
METHODS


Observational cohort study based on the DANBIO registry with geographical cluster pseudo-randomisation, analysed by emulating a randomised clinical trial. Main outcome was adjusted 1-year treatment retention (Cox regression). Furthermore, 6 months' remission rates (logistic regression), reasons for withdrawal and back-switching to originator were investigated (overall and stratified by indication).
RESULTS


Overall, of 1570 eligible patients, 1318 switched and were included (467 RA/321 PsA/530 AxSpA); 623 (47%) switched to GP2017, 695 (53%) to SB5. Baseline characteristics of the two clusters were largely similar, but some differences in registration practice were observed. The combined 1-year retention rate for the two biosimilars was 89.5%. Compared with SB5, estimated risk of withdrawal for GP2017 was lower (HR 0.60; 95% CI 0.42 to 0.86) and 6 months' remission rate was higher (OR 1.72; 95% CI 1.25 to 2.37). Stratified analyses gave similar results (statistically significant for RA). During 1 year, 8.5% and 12.9% withdrew GP2017 and SB5, respectively (primarily lack of effect and adverse events), of whom 48 patients (3.6%) back-switched.
CONCLUSION


This head-to-head comparison of GP2017 versus SB5 following a mandatory switch from the originator indicated differences in effectiveness in routine care. This may reflect a true difference, but other explanations, for example, differences in excipients, differences between clusters and residual confounding cannot be ruled out.",2021,"Compared with SB5, estimated risk of withdrawal for GP2017 was lower (HR 0.60; 95% CI 0.42 to 0.86) and 6 months' remission rate was higher (OR 1.72; 95% CI 1.25 to 2.37).","['1570 eligible patients, 1318 switched and were included (467 RA/321 PsA/530 AxSpA); 623 (47%) switched to GP2017, 695 (53%) to SB5', 'Observational cohort study based on the DANBIO registry with geographical cluster pseudo-randomisation', '1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator', 'patients with rheumatoid arthritis (RA)/psoriatic arthritis (PsA)/axial spondyloarthritis (AxSpA']","['adalimumab', 'GP2017 versus SB5', 'adalimumab biosimilars']","['remission rate', 'risk of withdrawal for GP2017', '1-year retention rate', 'remission rates (logistic regression), reasons for withdrawal and back-switching to originator']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C5198147', 'cui_str': 'GP2017'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1443865', 'cui_str': 'Geographical cluster'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C5198147', 'cui_str': 'GP2017'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C5198147', 'cui_str': 'GP2017'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]",1570.0,0.265816,"Compared with SB5, estimated risk of withdrawal for GP2017 was lower (HR 0.60; 95% CI 0.42 to 0.86) and 6 months' remission rate was higher (OR 1.72; 95% CI 1.25 to 2.37).","[{'ForeName': 'Hafsah', 'Initials': 'H', 'LastName': 'Nabi', 'Affiliation': 'DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen, Denmark hafsah.nabi@regionh.dk.'}, {'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Georgiadis', 'Affiliation': 'DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anne Gitte', 'Initials': 'AG', 'LastName': 'Loft', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hendricks', 'Affiliation': 'Danish Hospital for Rheumatic Diseases, University Hospital of Southern Denmark, Sønderborg, Denmark.'}, {'ForeName': 'Dorte Vendelbo', 'Initials': 'DV', 'LastName': 'Jensen', 'Affiliation': 'Department of Internal Medicine, Rønne Hospital, Rønne, Denmark.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Department of Rheumatology, North Denmark Regional Hospital, Hjørring, Denmark.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Chrysidis', 'Affiliation': 'Department of Rheumatology, Esbjerg Hospital, Esbjerg, Denmark.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Colic', 'Affiliation': 'Department of Rheumatology, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Danebod', 'Affiliation': 'Department of Rheumatology, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen University Hospital, Glostrup, Denmark.'}, {'ForeName': 'Mohamad Redha', 'Initials': 'MR', 'LastName': 'Hussein', 'Affiliation': 'Department of Rheumatology, Slagelse Hospital, Slagelse, Denmark.'}, {'ForeName': 'Maren Høgberget', 'Initials': 'MH', 'LastName': 'Kalisz', 'Affiliation': 'Department of Rheumatology, Gentofte and Herlev Hospital, Copenhagen University Hospital, Gentofte, Denmark.'}, {'ForeName': 'Salome', 'Initials': 'S', 'LastName': 'Kristensen', 'Affiliation': 'Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Lomborg', 'Affiliation': 'Department of Rheumatology, Vejle Hospital Lillebælt, Vejle, Denmark.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Manilo', 'Affiliation': 'Department of Rheumatology, Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Heidi Lausten', 'Initials': 'HL', 'LastName': 'Munk', 'Affiliation': 'Department of Rheumatology, Odense University Hospital, Odense C, Denmark.'}, {'ForeName': 'Jens Kristian', 'Initials': 'JK', 'LastName': 'Pedersen', 'Affiliation': 'Rheumatology Section, Department of Medicine M, Svendborg Hospital, Svendborg, Denmark.'}, {'ForeName': 'Johnny Lillelund', 'Initials': 'JL', 'LastName': 'Raun', 'Affiliation': 'Department of Rheumatology, Hospital Lillebælt, Fredericia, Kolding, Denmark.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Mehnert', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Niels Steen', 'Initials': 'NS', 'LastName': 'Krogh', 'Affiliation': 'Zitelab Aps, Copenhagen, Denmark.'}, {'ForeName': 'Merete Lund', 'Initials': 'ML', 'LastName': 'Hetland', 'Affiliation': 'DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Glintborg', 'Affiliation': 'DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen, Denmark.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2021-219951']
1183,33930408,Teprotumumab: Interpreting the Clinical Trials in the Context of Thyroid Eye Disease Pathogenesis and Current Therapies.,"Teprotumumab, a monoclonal antibody targeted against the insulin-like growth factor 1 (IGF-1) receptor, was recently approved by the United States Food and Drug Administration for the treatment of thyroid eye disease (TED). Phase 1 studies of teprotumumab for the treatment of malignancies demonstrated an acceptable safety profile but limited effectiveness. Basic research implicating the IGF-1 receptor on the CD-34+ orbital fibrocyte in the pathogenesis of TED renewed interest in the drug. Two multicenter, randomized, double-masked, clinical trials (phase 2 and 3) evaluated the efficacy of 8 infusions of teprotumumab every 3 weeks versus placebo in 170 patients with recent-onset active TED, as defined by a clinical activity score (CAS) of at least 4. Teprotumumab was superior to placebo for the primary efficacy end points in both studies: overall responder rate as defined by a reduction of 2 or more CAS points and a reduction of 2 mm or more in proptosis (69% vs. 20%; P < 0.001; phase 2 study) and proptosis responder rate as defined by a reduction of 2 mm or more in proptosis (83% vs. 10%; P < 0.001; phase 3 study). In both studies, treatment with teprotumumab compared with placebo achieved a significant mean reduction of proptosis (-3.0 mm vs. -0.3 mm, phase 2 study; -3.32 mm vs. -0.53 mm, phase 3 study) and CAS (-4.0 vs. -2.5, phase 2 study; -3.7 vs. -2.0, phase 3 study). Teprotumumab also resulted in a greater proportion of patients with a final CAS of 0 or 1, higher diplopia responder rate, and a larger improvement in the Graves' Ophthalmopathy Quality of Life overall score. More than half of patients (62%, phase 2 trial; 56%, phase 3 trial) who were primary end point responders maintained this response at 51 weeks after the last dose of therapy. The most common adverse events reported with teprotumumab included muscle spasms (25%), nausea (17%), alopecia (13%), diarrhea (13%), fatigue (10%), hearing impairment (10%), and hyperglycemia (8%). Teprotumumab is contraindicated for those with inflammatory bowel disease and who are pregnant. Although the current dosing regimen has proven effective for TED, dose-ranging studies including variable concentrations, infusion frequencies, and durations of teprotumumab therapy in the setting of TED have not been performed.",2021,"Teprotumumab was superior to placebo for the primary efficacy endpoints in both studies: overall responder rate as defined by a reduction of ≥2 CAS points and a reduction of ≥2 mm in proptosis (69% vs 20%, p<0.001, phase II) and proptosis responder rate as defined by a reduction of ≥2 mm in proptosis (83% vs 10%, p<0.001, phase III).","['170 patients with recent onset, active TED as defined by a clinical activity score (CAS) of at least 4']",['placebo'],"['muscle spasms', 'hyperglycemia', 'hearing impairment', 'alopecia', 'fatigue', 'nausea', ""Graves' Ophthalmopathy Quality of Life (GO-QoL) overall score"", 'mean reduction of proptosis', 'responder rate as defined by a reduction of ≥2 CAS points and a reduction of ≥2 mm in proptosis', 'diarrhea']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0339143', 'cui_str': 'Thyroid eye disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037763', 'cui_str': 'Spasm'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015300', 'cui_str': 'Exophthalmos'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",170.0,0.250098,"Teprotumumab was superior to placebo for the primary efficacy endpoints in both studies: overall responder rate as defined by a reduction of ≥2 CAS points and a reduction of ≥2 mm in proptosis (69% vs 20%, p<0.001, phase II) and proptosis responder rate as defined by a reduction of ≥2 mm in proptosis (83% vs 10%, p<0.001, phase III).","[{'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Winn', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Ophthalmology Section, Surgical Service, San Francisco Veterans Affairs Medical Center, San Francisco, California. Electronic address: bryan.winn@ucsf.edu.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Kersten', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}]",Ophthalmology,['10.1016/j.ophtha.2021.04.024']
1184,33935056,The effect of suboccipital muscle inhibition and posture correction exercises on chronic tension-type headaches.,"BACKGROUND


Compared with healthy people, patients with chronic tension-type headache (CTTH) are likely to have forward head postures (FHP) and a higher number of active trigger points (aTrP) on the suboccipital muscle.
OBJECTIVE


This study aims to verify how the suboccipital muscle inhibition (SMI) on aTrPs and the FHP correction exercise can effectively reduce symptoms of the CTTH patients.
METHOD


The subjects of this study were 45 individuals with CTTH, divided into three groups of 15 patients each: a) the SMI group using the myofascial release technique; b) the SMIEx group subject to both the SMI therapy and FHP correction exercises; and c) the control group. Group A and B were given the relevant interventions twice a week for four consecutive weeks, and went through the headache impact test (HIT-6) and examinations on the pressure pain threshold (PPT) of the headache areas, the type and number of myofascial trigger points (TrP), the soft tissue PPT, and the posture before and after the intervention.
RESULTS


There was a significant improvement in the HIT-6, the headache PPT, the soft tissue PPT, the TrP, and the posture in Group A and B patients to whom the SMI technique and SMIEx interventions were applied. The biggest reduction and increase in the HIT-6 and the headache PPT respectively were seen in the SMIEx group.
CONCLUSION


According to this study, the SMIEx can be an effective intervention for patients with CTTH.",2021,"The biggest reduction and increase in the HIT-6 and the headache PPT respectively were seen in the SMIEx group.
","['healthy people, patients with chronic tension-type headache (CTTH', 'patients with CTTH', '45 individuals with CTTH, divided into three groups of 15 patients each: a) the']","['FHP correction exercise', 'suboccipital muscle inhibition and posture correction exercises', 'SMI group using the myofascial release technique', 'SMIEx']","['chronic tension-type headaches', 'HIT-6 and the headache PPT', 'HIT-6, the headache PPT, the soft tissue PPT, the TrP, and the posture']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393738', 'cui_str': 'Chronic tension-type headache'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0448352', 'cui_str': 'Suboccipital muscle'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0454281', 'cui_str': 'Posture correction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}]","[{'cui': 'C0393738', 'cui_str': 'Chronic tension-type headache'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]",45.0,0.0136996,"The biggest reduction and increase in the HIT-6 and the headache PPT respectively were seen in the SMIEx group.
","[{'ForeName': 'Sung Hak', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191667']
1185,33945227,iGlarLixi reduces residual hyperglycemia in Japanese patients with type 2 diabetes uncontrolled on basal insulin: A post-hoc analysis of the LixiLan JP-L trial.,"INTRODUCTION


Treatments for type 2 diabetes targeting baseline glucose levels but not postprandial glucose can result in normalized fasting blood glucose but suboptimal overall glycemic control (high glycated hemoglobin): residual hyperglycemia. In Japanese patients with type 2 diabetes the predominant pathophysiology is a lower insulin secretory capacity, and residual hyperglycemia is common with basal insulin treatment. Single-injection, fixed-ratio combinations of glucagon-like peptide-1 receptor agonists and basal insulin have been developed. iGlarLixi (insulin glargine 100 units/mL [iGlar]: lixisenatide ratio of 1 unit:1 µg) is for specific use in Japan. Post-hoc analysis of the LixiLan JP-L trial (NCT02752412) compared the effect of iGlarLixi with iGlar on this specific subpopulation with residual hyperglycemia.
MATERIALS AND METHODS


Outcomes at week 26 (based on the last observation carried forward) were assessed in patients in the modified intent-to-treat population with baseline residual hyperglycemia.
RESULTS


Overall, 83 (32.5%) patients in the iGlarLixi group and 79 (30.7%) patients in the iGlar group had baseline residual hyperglycemia. The proportion of patients with residual hyperglycemia at week 26 decreased to 15.7% in the iGlarLixi group, and increased to 36.9% in the iGlar group. Patients in the iGlarLixi group had significantly greater reductions in glycated hemoglobin compared with the iGlar group (-0.72% difference between groups; P < 0.0001).
CONCLUSIONS


New data from this post-hoc analysis of the JP-L trial show that treatment with the fixed-ratio combination iGlarLixi reduced the proportion of Japanese patients with residual hyperglycemia from baseline to week 26 and significantly reduced glycated hemoglobin vs similar doses of iGlar alone.",2021,"Patients in the iGlarLixi group had significantly greater reductions in glycated hemoglobin compared with the iGlar group (-0.72% difference between groups; P < 0.0001).
","['Japanese patients with type 2 diabetes uncontrolled on basal insulin', 'Outcomes at week 26 (based on last observation carried forward) were assessed in patients in the modified intent-to-treat population with baseline residual hyperglycemia', 'Japanese patients with T2D']","['iGlarLixi with iGlar', 'iGlarLixi (insulin glargine 100 unit/mL [iGlar]: lixisenatide ratio of 1 U:1 µg', 'iGlarLixi']","['baseline residual hyperglycemia', 'glycated hemoglobin', 'residual hyperglycemia', 'proportion of patients with residual hyperglycemia']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.159316,"Patients in the iGlarLixi group had significantly greater reductions in glycated hemoglobin compared with the iGlar group (-0.72% difference between groups; P < 0.0001).
","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yabe', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Iizuka', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Baxter', 'Affiliation': 'Medical Affairs, Sanofi, Reading, UK.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Watanabe', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kaneto', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13563']
1186,33949332,Internal stenting across the pancreaticojejunostomy anastomosis and main pancreatic duct after pancreaticoduodenectomy.,"BACKGROUND


Postoperative pancreatic fistula is associated with high morbidity and mortality. Studies have reported internal stenting of the pancreaticojejunostomy anastomosis to reduce postoperative pancreatic fistula, but it is still controversial.
MATERIALS AND METHODS


Fifty patients undergoing elective pancreaticoduodenectomy, were included. Patients were divided into 2 groups in randomized fashion; Group A (n-25) without internal stenting across the pancreaticojejunostomy anastomosis and Group B (n-25) with internal stenting of the pancreaticojejunostomy anastomosis. Primary endpoint was the occurrence of postoperative pancreatic fistula.
RESULT


Both the groups were comparable in demographics, co morbidities, pathologies, pancreatic texture and pancreatic duct diameter. Out of 50 patients studied, total 23(46.0%) patients developed postoperative pancreatic fistula. Ten (40%) in group A and 13 (52%) in group B (p 0.156). Sixteen patients (32%) developed Grade A and 7 (14%) patients had Grade B postoperative pancreatic fistula. In group A, 6 patients developed grade A and 4 patients developed grade B postoperative pancreatic fistula. In group B, 10 patients developed grade A and 3 patients developed grade B postoperative pancreatic fistula. There was no Grade C fistula. All patients had satisfactory recovery on conservative management. Eight patients (16%) developed delayed gastric emptying [5 in group A and 3 in group B; p-0.366]. Six patients developed superficial surgical site infection (2 in group A and 4 in group B; p-0.445). The length of hospital stay was comparable in two groups. There was no mortality.
CONCLUSION


Internal stenting of pancreaticojejunostomy anastomosis does not decrease the rate of postoperative pancreatic fistula after pancreaticoduodenectomy.",2021,Six patients developed superficial surgical site infection (2 in group A and 4 in group B; p-0.445).,"['50 patients studied, total 23(46.0', 'Fifty patients undergoing elective pancreaticoduodenectomy, were included']","['randomized fashion; Group A (n-25) without internal stenting across the pancreaticojejunostomy anastomosis and Group B (n-25) with internal stenting of the pancreaticojejunostomy anastomosis', 'Internal stenting', 'Internal stenting of pancreaticojejunostomy anastomosis']","['grade B postoperative pancreatic fistula', 'length of hospital stay', 'superficial surgical site infection', 'delayed gastric emptying', 'postoperative pancreatic fistula', 'mortality', 'demographics, co morbidities, pathologies, pancreatic texture and pancreatic duct diameter', 'occurrence of postoperative pancreatic fistula', 'Grade B postoperative pancreatic fistula', 'rate of postoperative pancreatic fistula']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0441806', 'cui_str': 'Grade B'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",50.0,0.0239487,Six patients developed superficial surgical site infection (2 in group A and 4 in group B; p-0.445).,"[{'ForeName': 'Kamaldeep', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Lileswar', 'Initials': 'L', 'LastName': 'Kaman', 'Affiliation': 'Department of Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Cherring', 'Initials': 'C', 'LastName': 'Tandup', 'Affiliation': 'Department of Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Niladri', 'Initials': 'N', 'LastName': 'Raypattanaik', 'Affiliation': 'Department of Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Dahiya', 'Affiliation': 'Department of Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Arunanshu', 'Initials': 'A', 'LastName': 'Behera', 'Affiliation': 'Department of Surgery, PGIMER, Chandigarh, India.'}]",Polski przeglad chirurgiczny,['10.5604/01.3001.0014.7225']
1187,33950535,Cost-effectiveness implications of increasing the efficiency of the extended-release naltrexone induction process for the treatment of opioid use disorder: a secondary analysis.,"BACKGROUND AND AIMS


In a US randomized-effectiveness trial comparing extended-release naltrexone (XR-NTX) with buprenorphine-naloxone (BUP-NX) for the prevention of opioid relapse among participants recruited during inpatient detoxification (CTN-0051), the requirement to complete opioid detoxification prior to initiating XR-NTX resulted in lower rates of initiation of XR-NTX (72% XR-NTX versus 94% BUP-NX).
DESIGN


This was a retrospective secondary analysis of CTN-0051 trial data, including follow-up data over 24-36 weeks.
SETTING


Eight community-based, inpatient-detoxification and follow-up outpatient treatment facilities in the United States.
PARTICIPANTS


A total of 283 participants randomized to receive XR-NTX.
MEASUREMENTS


Efficiency was estimated using a multivariable generalized structural equation model to explore simultaneous determinants of XR-NTX induction and induction duration (detoxification + residential days). Cost-effectiveness was estimated from the health-care sector perspective and included expected costs and quality-adjusted life-years (QALYs).
FINDINGS


Treatment site was the only modifiable factor that simultaneously increased the likelihood of XR-NTX induction and decreased induction duration. Incorporating the higher predicted probability of XR-NTX induction, and fewer predicted days of detoxification and subsequent residential treatment into the cost-effectiveness framework, reduced the incremental average 24-week total cost of XR-NTX treatment from $5317 more than that of BUP-NX (P = 0.01) to a non-statistically-significant difference of $1016 (P = 0.63). QALYs gained remained similar across arms.
CONCLUSION


Adopting an efficient model of extended-release naltrexone initiation could result in extended-release naltrexone and buprenorphine-naloxone being of comparable economic value from the health-care sector perspective over 24-36 weeks for patients seeking treatment for opioid use disorder at an inpatient detoxification facility.",2021,"QALYs gained remained similar across arms.
","['participants recruited during inpatient detoxification (CTN-0051', '283 participants randomized to receive', 'patients seeking treatment for opioid use disorder at an inpatient detoxification facility', 'Opioid Use Disorder', 'Eight community-based, inpatient-detoxification and follow-up outpatient treatment facilities in the USA']","['XR-NTX', 'buprenorphine-naloxone', 'naltrexone (XR-NTX', 'buprenorphine-naloxone (BUP-NX']","['XR-NTX induction and induction duration (detoxification + residential days', 'costs and quality-adjusted life-years (QALYs', 'likelihood of XR-NTX induction and decreased induction duration', 'Cost-effectiveness', 'relapse rates and average healthcare costs']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0917591', 'cui_str': 'CTN'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}]",283.0,0.0860901,"QALYs gained remained similar across arms.
","[{'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Jeng', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'McCollister', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Leff', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Matisyahu', 'Initials': 'M', 'LastName': 'Shulman', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Novo', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15531']
1188,33947825,"Short-term effect of adding Graston technique to exercise program in treatment of patients with cervicogenic headache: a single-blinded, randomized controlled trial.","BACKGROUND


Physical therapists may use the Graston technique to relieve soft-tissue restrictions and pain in the upper cervical region. However, no studies have tested the efficacy of the Graston technique in patients with cervicogenic headache.
AIM


The aim of the study was to investigate the effect of adding the Graston technique to an exercise program on pain intensity, neck disability, cervical range of motion, headache frequency and duration, and medication intake in subjects with cervicogenic headache.
DESIGN


The design of this study was a single-blinded (assessor), randomized controlled trial.
SETTING


The setting was outpatient rehabilitation clinic.
POPULATION


Sixty patients, from 35 to 50 years old, with cervicogenic headache have participated in the study. Patients were recruited from the outpatient clinics of Tala general hospital in Menoufia governorate.
METHODS


Patients were assigned randomly into two groups. Patients in the study group received the Graston technique in addition to an exercise program, while patients in the control group received the exercise program only. All patients received 3 sessions a week for 4 weeks. The primary outcome measure was the Visual Analogue Scale (VAS), while the secondary outcome measures were Neck Disability Index (NDI), Cervical Range of Motion (CROM), headache frequency and duration, and medication intake. All outcomes were measured at baseline, after 2 weeks as well as after 4 weeks of intervention.
RESULTS


After 2 weeks of the treatment, statistically significant differences were found in all the measured outcomes (P<0.05) in favor of the Graston group except for neck extension (P=0.08). After 4 weeks of the intervention, statistically significant differences were found in all the measured outcomes (P<0.05) in favor of the Graston group.
CONCLUSIONS


Short-term effect of using the Graston technique in combination with an exercise program can reduce pain, decrease headache frequency and duration, and medication intake more than the exercise program alone in the medium-term.
CLINICAL REHABILITATION IMPACT


Although the study results for NDI and neck ROM were statistically significant, it is neither clinically relevant change nor clearly outside the range of measurement error.",2021,"After 4 weeks of the intervention, statistically significant differences were found in all the measured outcomes (p< 0.05) in favor of the Graston group.
","['subjects with cervicogenic headache', 'Patients', 'patients with cervicogenic headache', 'Sixty patients,35 to 50 years old, with cervicogenic headache have participated in the study', 'Patients were recruited from the outpatient clinics of Tala general hospital in Menoufia governorate', 'Outpatient rehabilitation clinic']","['Graston technique in addition to an exercise program', 'exercise program only', 'Graston technique to an exercise program', 'graston technique to exercise program', 'exercise program']","['NDI and neck ROM', 'pain, decrease headache frequency and duration, and medication intake', 'pain intensity, neck disability, cervical range of motion, headache frequency and duration, and medication intake', 'neck disability index (NDI), cervical range of motion(CROM), headache frequency and duration, and medication intake', 'visual analogue scale(VAS']","[{'cui': 'C0458101', 'cui_str': 'Cervicogenic headache'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0405887,"After 4 weeks of the intervention, statistically significant differences were found in all the measured outcomes (p< 0.05) in favor of the Graston group.
","[{'ForeName': 'Nabil M', 'Initials': 'NM', 'LastName': 'Abdel-Aal', 'Affiliation': 'Department of Physical Therapy for Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt - nabil.mahmoud@cu.edu.eg.'}, {'ForeName': 'Mohsen M', 'Initials': 'MM', 'LastName': 'Elsayyad', 'Affiliation': 'Department of Physical Therapy for Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Megahed', 'Affiliation': 'Department of Physical Therapy, Tala General Hospital, Monofia, Egypt.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.21.06595-3']
1189,33963004,"Interface leakage during neonatal CPAP treatment: a randomised, cross-over trial.","OBJECTIVE


To determine leakage for two neonatal continuous positive airway pressure (CPAP) interfaces and evaluate leak-corrective manoeuvres.
DESIGN


The ToNIL (Trial of NCPAP Interface Leakage) study was a randomised, clinical, cross-over trial with data collection between August 2018 and October 2019. The primary outcome was blinded to the treating staff.
SETTING


One secondary, 8-bed neonatal intensive care unit (NICU) and three larger (>15 beds), academic NICU referral centres.
PATIENTS


Newborn infants with CPAP were screened (n=73), and those with stable spontaneous breathing, low oxygen requirement, postmenstrual age (PMA) over 28 weeks and no comorbidities were eligible. In total, 50 infants were included (median PMA 33 completed weeks).
INTERVENTIONS


Leakage was measured for both prongs and nasal mask, before and after leak-corrective manoeuvres. Interface application was performed in a randomised order by a nurse, blinded to the measured leakage.
MAIN OUTCOME MEASURES


30 s average leakage, measured in litres per minute (LPM).
RESULTS


Analyses showed a significantly lower leakage (mean difference 0.86 LPM, 95% CI 0.07 to 1.65) with prongs (median 2.01 LPM, IQR 1.00-2.80) than nasal mask (median 2.45 LPM, IQR 0.99-5.11). Leak-corrective manoeuvres reduced leakage significantly for both prongs (median 1.22 LPM, IQR 0.54-1.87) and nasal mask (median 2.35 LPM, IQR 0.76-4.75).
CONCLUSIONS


Large leakages were common for both interfaces, less with prongs. Simple care manoeuvres reduced leakage for both interfaces. This is the first report of absolute leakage for nasal interfaces and should encourage further studies on leakage during CPAP treatment.",2021,"Leak-corrective manoeuvres reduced leakage significantly for both prongs (median 1.22 LPM, IQR 0.54-1.87) and nasal mask (median 2.35 LPM, IQR 0.76-4.75).
","['50 infants were included (median PMA 33 completed weeks', 'August 2018 and October 2019', 'Newborn infants with CPAP were screened (n=73), and those with stable spontaneous breathing, low oxygen requirement, postmenstrual age (PMA) over 28 weeks and no comorbidities were eligible']",[],"['nasal mask', '30\u2009s average leakage, measured in litres per minute (LPM', 'leakage', 'Interface leakage', '8-bed neonatal intensive care unit (NICU) and three larger (>15 beds), academic NICU referral centres', 'treating staff']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",[],"[{'cui': 'C2711254', 'cui_str': 'Nasal mask'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]",50.0,0.160868,"Leak-corrective manoeuvres reduced leakage significantly for both prongs (median 1.22 LPM, IQR 0.54-1.87) and nasal mask (median 2.35 LPM, IQR 0.76-4.75).
","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Falk', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden markus.falk@ki.se.""}, {'ForeName': 'Kolbrun', 'Initials': 'K', 'LastName': 'Gunnarsdottir', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Baldursdottir', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Snorri', 'Initials': 'S', 'LastName': 'Donaldsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Baldvin', 'Initials': 'B', 'LastName': 'Jonsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Drevhammar', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2021-321579']
1190,33955162,Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects.,"The neuroprotective agent edaravone is an intravenous treatment for amyotrophic lateral sclerosis. As intravenous administration burdens patients, orally administered treatments are needed. This phase 1, open-label, single-dose crossover study in 42 healthy adults evaluated bioequivalence of a 105-mg edaravone oral suspension and intravenous edaravone (60 mg/60 min). The evaluation was whether the 90% confidence intervals (CIs) for the ratio of the maximum plasma concentration (C max  ) and area under the plasma concentration-time curve from time 0 to the last quantifiable time point and to infinity of unchanged edaravone were between the bioequivalence limit of 0.80 and 1.25. Metabolic profiles and elimination pathways were also compared between the 2 routes. Geometric mean ratios and 90%CIs of area under the plasma concentration-time curve from time 0 to the last quantifiable time point and to infinity for unchanged edaravone satisfied bioequivalence limits. The geometric mean ratio and its lower limit of 90%CI of C max  of the 105-mg oral suspension compared with 60-mg intravenous formulations for unchanged edaravone fell within bioequivalence limits. Both formulations showed triphasic plasma concentration-time profiles of unchanged edaravone after reaching C max  . Plasma concentrations of edaravone inactive metabolites after oral administration were higher than with intravenous administration. Edaravone in both routes underwent urinary excretion, mainly as the glucuronide conjugate and, to a lesser extent, as the sulfate conjugate. Urinary excretion of unchanged edaravone was low, and urinary relative composition ratios of unchanged edaravone and metabolites were similar for both formulations. These findings showed equivalent exposure of the 105-mg oral suspension of edaravone to the 60-mg intravenous formulation, supporting further investigation of the oral suspension for treating amyotrophic lateral sclerosis.",2021,Both formulations showed triphasic plasma concentration-time profiles of unchanged edaravone after reaching C max  .,"['Healthy Adult Subjects', '42 healthy adults evaluated bioequivalence of a 105-mg edaravone oral suspension and intravenous edaravone (60 mg/60 min', 'amyotrophic lateral sclerosis']","['Oral Suspension and Intravenous Formulation of Edaravone', 'Edaravone']","['geometric mean ratio', 'Geometric mean ratios and 90%CIs of area under the plasma concentration-time curve', 'Metabolic profiles and elimination pathways', 'Urinary excretion of unchanged edaravone', 'Plasma concentrations of edaravone inactive metabolites', 'maximum plasma concentration (C max  ) and area under the plasma concentration-time curve', 'triphasic plasma concentration-time profiles']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0991537', 'cui_str': 'Oral suspension'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}]","[{'cui': 'C0991537', 'cui_str': 'Oral suspension'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205185', 'cui_str': 'Triphasic'}]",42.0,0.0564784,Both formulations showed triphasic plasma concentration-time profiles of unchanged edaravone after reaching C max  .,"[{'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Shimizu', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Youichi', 'Initials': 'Y', 'LastName': 'Shiide', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Hirai', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Munetomo', 'Initials': 'M', 'LastName': 'Matsuda', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Nakamaru', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuoki', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.952']
1191,33961343,Clinical Efficacy of Minimally Invasive Elastic Stable Intramedullary Nailing for Limb Long Bone Fractures in Children.,"OBJECTIVE


The aim of the present paper was to investigate the clinical efficacy of minimally invasive elastic stable intramedullary nailing (ESIN) for long bone fractures in children.
METHODS


A total of 350 children with limb fractures from June 2012 to June 2018 were recruited and randomized into two groups: an ESIN group (n = 175) treated with elastic stable intramedullary nailing, and an MPIF group (n = 175), treated with metal plate internal fixation. Both groups received the same physical examination and routine medication. Operation related indexes, clinical efficacy, complications, and postoperative quality of life scores were analyzed and compared.
RESULTS


The operation time, intraoperative blood loss, hospitalization time, and fracture healing time in the ESIN group were 43.74 ± 4.96 min, 8.14 ± 1.34 mL, 5.97 ± 1.88 days, and 55.89 ± 5.61 days, respectively, which were all significantly less than those in the MPIF group (all P < 0.001). In terms of common complications after limb fracture treatment, there were 6 cases of osteomyelitis, 5 cases of skin irritation response, and 7 cases of inflammatory granuloma in the MPIF group. There were 2 cases of skin irritation response and 5 cases of inflammatory granuloma in the ESIN group. The incidence of postoperative complications in the ESIN group was 4.00%, which was significantly lower than that in MPIF group (10.29%) (P < 0.05). The effective rate for recovery condition in the ESIN group (93.71%) was significantly higher than that in the MPIF group (P < 0.001). The quality of life scores after treatment in both groups were improved, while the score in the ESIN group was significantly higher than that in the MPIF group (79.43%) (P < 0.001). The postoperative satisfaction rate in the ESIN group (94.29%) was significantly higher than that in the MPIF group (86.29%) (P < 0.05). The quality of life scores after treatment in both groups were improved, while the score in the ESIN group was significantly higher than that in the MPIF group (P < 0.001). The postoperative satisfaction rate and the acceptance rate for adjacent joint function in the ESIN group (100%) were significantly higher than those in the MPIF group (92.00%) (P < 0.0001).
CONCLUSION


Elastic stable intramedullary nailing is a minimally invasive procedure for long bone fractures in children. It can effectively improve the operation-related indicators and postoperative quality of life and reduce the incidence of complications.",2021,The postoperative satisfaction rate in the ESIN group (94.29%) was significantly higher than that in the MPIF group (86.29%),"['350 children with limb fractures from June 2012 to June 2018', 'children', 'Limb Long Bone Fractures in Children']","['MPIF', 'Minimally Invasive Elastic Stable Intramedullary Nailing', 'ESIN', 'Elastic stable intramedullary nailing', 'elastic stable intramedullary nailing, and an MPIF group (n =\u2009175), treated with metal plate internal fixation', 'minimally invasive elastic stable intramedullary nailing (ESIN']","['clinical efficacy', 'postoperative satisfaction rate', 'skin irritation response', 'clinical efficacy, complications, and postoperative quality of life scores', 'operation time, intraoperative blood loss, hospitalization time, and fracture healing time', 'effective rate for recovery condition', 'postoperative satisfaction rate and the acceptance rate for adjacent joint function', 'quality of life scores', 'incidence of postoperative complications']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0596838', 'cui_str': 'Limb fracture'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0222647', 'cui_str': 'Structure of long bone'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013866', 'cui_str': 'Electrodeposition'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",350.0,0.0158386,The postoperative satisfaction rate in the ESIN group (94.29%) was significantly higher than that in the MPIF group (86.29%),"[{'ForeName': 'Liangchao', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ""Department of Orthopaedics, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yichen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Jiao', 'Affiliation': ""Department of Orthopaedics, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}]",Orthopaedic surgery,['10.1111/os.12977']
1192,33951024,A randomized clinical trial of single dose liposomal bupivacaine versus indwelling analgesic catheter in patients undergoing surgical stabilization of rib fractures.,"INTRODUCTION


Locoregional analgesia (LRA) remains underused in patients with chest wall injuries. Surgical stabilization of rib fractures (SSRF) offers an opportunity to deliver surgeon-directed LRA under direct visualization at the site of surgical intervention. We hypothesized that a single-dose liposomal bupivacaine (LB) intercostal nerve block provides comparable analgesia to an indwelling, peripheral nerve plane analgesic catheter with continuous bupivacaine infusion (IC), each placed during SSRF.
METHODS


Noninferiority, single-center, randomized clinical trial (2017-2020) was performed. Patients were randomized to receive either IC or LB during SSRF. The IC was tunneled into the surgical field (subscapular space), and LB involved thoracoscopic intercostal blocks of ribs 3 to 8. The primary outcome was the Sequential Clinical Assessment of Respiratory Function score, measured daily for 5 days postoperatively. Secondary outcomes included daily narcotic equivalents and failure of primary LRA, defined as requiring a second LRA modality.
RESULTS


Thirty-four patients were enrolled: 16 IC and 18 LB. Age, Injury Severity Score, RibScore, Blunt Pulmonary Contusion Score, and use of nonnarcotic analgesics was similar between groups. Duration of IC was 4.5 days. There were three failures in the IC group versus one in the LB group (p = 0.23). There was no significant difference in Sequential Clinical Assessment of Respiratory Function score between the IC and LB groups. On postoperative days 2 to 4, narcotic requirements were less than half in the LB, as compared with the IC group; however, this difference was not statistically significant. Average wholesale price was US $605 for IC and US $434 for LB.
CONCLUSION


In this noninferiority trial, LB provided at least comparable and potentially superior LRA as compared with IC among patients undergoing SSRF.
LEVEL OF EVIDENCE


Therapeutic, level II.",2021,"In this non-inferiority trial, LB provided at least comparable, and potentially superior LRA as compared to IC among patients undergoing SSRF.
","['Non-inferiority, single center, randomized clinical trial (2017-2020', 'patients undergoing SSRF', 'patients undergoing surgical stabilization of rib fractures', 'rib fractures (SSRF', 'patients with chest wall injuries', 'Thirty-four patients were enrolled; 16 IC and 18 LB']","['liposomal bupivacaine (LB) intercostal nerve block', 'Loco-regional analgesia (LRA', 'IC or LB', 'liposomal bupivacaine', 'bupivacaine infusion (IC']","['Duration of IC', 'Age, injury severity score, RibScore, Blunt Pulmonary Contusion Score, and use of non-narcotic analgesics', 'daily narcotic equivalents and failure of primary LRA, defined as requiring a second LRA modality', 'SCARF score', 'Sequential Clinical Assessment of Respiratory Function (SCARF) score, measured daily for 5 days post-operatively', 'narcotic requirements', 'Average wholesale price']","[{'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}, {'cui': 'C0272434', 'cui_str': 'Injury of chest wall'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0347625', 'cui_str': 'Contusion of lung'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0558288', 'cui_str': 'As required'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0080045', 'cui_str': 'Prices'}]",34.0,0.227496,"In this non-inferiority trial, LB provided at least comparable, and potentially superior LRA as compared to IC among patients undergoing SSRF.
","[{'ForeName': 'Kiara N', 'Initials': 'KN', 'LastName': 'Leasia', 'Affiliation': 'From the Department of Surgery (K.N.L., J.T.H.P., E.P.-P., K.H., A.C., C.C.B., J.J.C., M.J.C., R.L., K.B.P., E.E.M., F.M.P.), Department of Anesthesiology (C.C.), and Department of Pharmacy (C.P.), Denver Health and Hospital Authority, Denver, Colorado.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ciarallo', 'Affiliation': ''}, {'ForeName': 'Jonne T H', 'Initials': 'JTH', 'LastName': 'Prins', 'Affiliation': ''}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Preslaski', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Perkins-Pride', 'Affiliation': ''}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hardin', 'Affiliation': ''}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Cralley', 'Affiliation': ''}, {'ForeName': 'Clay Cothren', 'Initials': 'CC', 'LastName': 'Burlew', 'Affiliation': ''}, {'ForeName': 'Jamie J', 'Initials': 'JJ', 'LastName': 'Coleman', 'Affiliation': ''}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lawless', 'Affiliation': ''}, {'ForeName': 'K Barry', 'Initials': 'KB', 'LastName': 'Platnick', 'Affiliation': ''}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Fredric M', 'Initials': 'FM', 'LastName': 'Pieracci', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003264']
1193,33958325,"Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial.","OBJECTIVES


To compare the benefits of a tight-control/treat-to-target strategy (TC/T2T) in axial spondyloarthritis (axSpA) with those of usual care (UC).
METHODS


Pragmatic, prospective, cluster-randomised, controlled, open, 1-year trial (NCT03043846). 18 centres were randomised (1:1). Patients met Axial Spondylo Arthritis International Society (ASAS) criteria for axSpA, had an Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥2.1, received non-optimal treatment by non-steroidal anti-inflammatory drugs and were biologic-naive.
INTERVENTIONS


(1)  TC/T2T : visits every 4 weeks and prespecified strategy based on treatment intensification until achieving target (ie, ASDAS <2.1); (2)  UC:  visits every 12 weeks and treatment at the rheumatologist's discretion.
MAIN OUTCOME


Percentage of patients with a ≥30% improvement on the ASAS-Health Index (ASAS-HI). Other efficacy outcomes and adverse events were recorded. A health economic evaluation was performed.
STATISTICAL ANALYSIS


Two-level mixed models were used to estimate efficacy outcomes. Cost-effectiveness was assessed by the incremental cost per quality-adjusted life-year (QALY) gained for TC/T2T versus UC.
RESULTS


160 patients were included (80/group). Mean (SD) age was 37.9 (11.0) years and disease duration was 3.7 (6.2) years; 51.2% were men. ASDAS at inclusion was 3.0 (0.7), and ASAS-HI was 8.6 (3.7). ASAS-HI improved by ≥30% in 47.3% of the TC/T2T arm and in 36.1% of those receiving UC (non-significant). All secondary efficacy outcomes were more frequent in the TC/T2T arm, although not all statistically significant. Safety was similar in both arms. From a societal perspective, TC/T2T resulted in an additional 0.04 QALY, and saved €472 compared with UC.
CONCLUSION


TC/T2T was not significantly superior to UC for the primary outcome, while many secondary efficacy outcomes favoured it, had a similar safety profile and was favourable from a societal health economic perspective.
TRIAL REGISTRATION NUMBER


NCT03043846.",2021,ASAS-HI improved by ≥30% in 47.3% of the TC/T2T arm and in 36.1% of those receiving UC (non-significant).,"['Mean (SD) age was 37.9', '18 centres', '11.0) years and disease duration was 3.7 (6.2) years; 51.2% were men', 'axial spondyloarthritis', '160 patients were included (80/group']","['tight-control and treat-to-target strategy', 'tight-control/treat-to-target strategy (TC/T2T) in axial spondyloarthritis (axSpA) with those of usual care (UC']","['ASAS-HI', 'adverse events', 'ASAS-Health Index (ASAS-HI', 'Cost-effectiveness', 'Safety', 'Ankylosing Spondylitis Disease Activity Score (ASDAS']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}]","[{'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",160.0,0.136496,ASAS-HI improved by ≥30% in 47.3% of the TC/T2T arm and in 36.1% of those receiving UC (non-significant).,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Molto', 'Affiliation': 'Rheumatology Department, Hospital Cochin, Paris, France anna.molto@aphp.fr.'}, {'ForeName': 'Clementina', 'Initials': 'C', 'LastName': 'López-Medina', 'Affiliation': 'ECAMO team, INSERM U1153, Paris, France.'}, {'ForeName': 'Filip E', 'Initials': 'FE', 'LastName': 'Van den Bosch', 'Affiliation': 'Rheumatology Department, University Hospital Ghent, Gent, Oost-Vlaanderen, Belgium.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Boonen', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Webers', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Emanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Rheumatology Department, Le Mans Hospital, Le Mans, France.'}, {'ForeName': 'Floris A', 'Initials': 'FA', 'LastName': 'van Gaalen', 'Affiliation': 'Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soubrier', 'Affiliation': 'Rheumatology, CHU, Clermont-Ferrand, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Claudepierre', 'Affiliation': 'Rheumatology, Henri Mondor Hospital Rheumatology Service, Creteil, France.'}, {'ForeName': 'Athan', 'Initials': 'A', 'LastName': 'Baillet', 'Affiliation': 'Rheumatology, Hopital Sud, Echirolles, France.'}, {'ForeName': 'Mirian', 'Initials': 'M', 'LastName': 'Starmans-Kool', 'Affiliation': 'Rheumatology, Zuyderland Medical Centre Heerlen, Heerlen, The Netherlands.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Spoorenberg', 'Affiliation': 'Rheumatology & Clinical Immunology, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Jacques', 'Affiliation': 'Rheumatology Department, University Hospital Ghent, Gent, Oost-Vlaanderen, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Carron', 'Affiliation': 'Rheumatology, VIB-UGent Center for Inflammation Research, Zwijnaarde, Belgium.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Joos', 'Affiliation': 'Rheumatology, ZNA UKJA, Antwerpen, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lenaerts', 'Affiliation': 'Rheumatology, Reumainstituut Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': 'Rheumatology Department, University Hospital Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'Rheumatology, Bois-Guillaume CHU, Rouen, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Ruyssen-Witrand', 'Affiliation': 'Rheumatology, University Hospital Centre Toulouse, Toulouse, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Sparsa', 'Affiliation': 'Rheumatology department, Hospital Centre Mulhouse, Mulhouse, France.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'van Tubergen', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Rheumatology Department, Hospital Cochin, Paris, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-219585']
1194,34388099,Integrated Clinical and CT Based Artificial Intelligence Nomogram for Predicting Severity and Need for Ventilator Support in COVID-19 Patients: A Multi-Site Study.,"Almost 25% of COVID-19 patients end up in ICU needing critical mechanical ventilation support. There is currently no validated objective way to predict which patients will end up needing ventilator support, when the disease is mild and not progressed. N = 869 patients from two sites (D 1 : N = 822, D 2 : N = 47) with baseline clinical characteristics and chest CT scans were considered for this study. The entire dataset was randomly divided into 70% training, D 1 train  (N = 606) and 30% test-set (D test : D 1 test  (N = 216) + D 2  (N = 47)). An expert radiologist delineated ground-glass-opacities (GGOs) and consolidation regions on a subset of D 1 train , (D 1 train_sub , N = 88). These regions were automatically segmented and used along with their corresponding CT volumes to train an imaging AI predictor (AIP) on D 1 train  to predict the need of mechanical ventilators for COVID-19 patients. Finally, top five prognostic clinical factors selected using univariate analysis were integrated with AIP to construct an integrated clinical and AI imaging nomogram (ClAIN). Univariate analysis identified lactate dehydrogenase, prothrombin time, aspartate aminotransferase, %lymphocytes, albumin as top five prognostic clinical features. AIP yielded an AUC of 0.81 on D test  and was independently prognostic irrespective of other clinical parameters on multivariable analysis (p<0.001). ClAIN improved the performance over AIP yielding an AUC of 0.84 (p = 0.04) on D test . ClAIN outperformed AIP in predicting which COVID-19 patients ended up needing a ventilator. Our results across multiple sites suggest that ClAIN could help identify COVID-19 with severe disease more precisely and likely to end up on a life-saving mechanical ventilation.",2021,ClAIN improved the performance over AIP yielding an AUC of 0.84 (p=0.04) on D test.,"['patients from two sites (D1: N=822, D2: N=47) with baseline clinical characteristics and chest CT scans', 'COVID-19 patients']","['Integrated Clinical and CT based Artificial Intelligence nomogram', 'D1 train ']","['lactate dehydrogenase, prothrombin time, aspartate aminotransferase, %lymphocytes, albumin as top five prognostic clinical features']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C1450294', 'cui_str': 'Nomogram chart'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",869.0,0.0921237,ClAIN improved the performance over AIP yielding an AUC of 0.84 (p=0.04) on D test.,"[{'ForeName': 'Amogh', 'Initials': 'A', 'LastName': 'Hiremath', 'Affiliation': ''}, {'ForeName': 'Kaustav', 'Initials': 'K', 'LastName': 'Bera', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Pranjal', 'Initials': 'P', 'LastName': 'Vaidya', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Alilou', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Furin', 'Affiliation': ''}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Armitage', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gilkeson', 'Affiliation': ''}, {'ForeName': 'Mengyao', 'Initials': 'M', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Pingfu', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Madabhushi', 'Affiliation': ''}]",IEEE journal of biomedical and health informatics,['10.1109/JBHI.2021.3103389']
1195,34388007,Predicted Risks of Cardiovascular Disease Following Chemotherapy and Radiotherapy in the UK NCRI RAPID Trial of Positron Emission Tomography-Directed Therapy for Early-Stage Hodgkin Lymphoma.,"PURPOSE


The contemporary management of early-stage Hodgkin lymphoma (ES-HL) involves balancing the risk of late adverse effects of radiotherapy against the increased risk of relapse if radiotherapy is omitted. This study provides information on the risk of radiation-related cardiovascular disease to help personalize the delivery of radiotherapy in ES-HL.
METHODS


We predicted 30-year absolute cardiovascular risk from chemotherapy and involved field radiotherapy in patients who were positron emission tomography (PET)-negative following three cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine chemotherapy within a UK randomized trial of PET-directed therapy for ES-HL. Cardiac and carotid radiation doses and chemotherapy exposure were combined with established dose-response relationships and population-based mortality and incidence rates.
RESULTS


Average mean heart dose was 4.0 Gy (range 0.1-24.0 Gy) and average bilateral common carotid artery dose was 21.5 Gy (range 0.6-38.1 Gy), based on individualized cardiovascular dosimetry for 144 PET-negative patients receiving involved field radiotherapy. The average predicted 30-year radiation-related absolute excess overall cardiovascular mortality was 0.56% (range 0.01%-6.79%; < 0.5% in 67% of patients and > 1% in 15%), whereas average predicted 30-year excess incidence was 6.24% (range 0.31%-31.09%; < 5% in 58% of patients and > 10% in 24%). For cardiac disease, the average predicted 30-year radiation-related absolute excess mortality was 0.42% (0.79% with mediastinal involvement and 0.05% without) and for stroke, it was 0.14%.
CONCLUSION


Predicted excess cardiovascular risk is small for most patients, so radiotherapy may provide net benefit. However, for a minority of patients receiving high doses of radiation to cardiovascular structures, it may be preferable to consider advanced radiotherapy techniques to reduce doses or to omit radiotherapy and accept the increased relapse risk. Individual assessment of cardiovascular and other risks before treatment would allow personalized decision making about radiotherapy in ES-HL.",2021,"For cardiac disease, the average predicted 30-year radiation-related absolute excess mortality was 0.42% (0.79% with mediastinal involvement and 0.05% without) and for stroke, it was 0.14%.
","['early-stage Hodgkin lymphoma (ES-HL', 'patients who were positron emission tomography (PET)-negative following three cycles of', '144 PET-negative patients receiving involved', 'Early-Stage Hodgkin Lymphoma']","['radiotherapy', 'Chemotherapy and Radiotherapy', 'doxorubicin, bleomycin, vinblastine, and dacarbazine chemotherapy', 'field radiotherapy', 'Positron Emission Tomography-Directed Therapy', 'chemotherapy and involved field radiotherapy']","['relapse risk', 'cardiovascular mortality']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0620259,"For cardiac disease, the average predicted 30-year radiation-related absolute excess mortality was 0.42% (0.79% with mediastinal involvement and 0.05% without) and for stroke, it was 0.14%.
","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cutter', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Ramroth', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Diez', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, United Kingdom.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Buckle', 'Affiliation': 'Oxford Cancer and Haematology Centre, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Ntentas', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Bilyana', 'Initials': 'B', 'LastName': 'Popova', 'Affiliation': 'Cancer Research UK, UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Clifton-Hadley', 'Affiliation': 'Cancer Research UK, UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hoskin', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, United Kingdom.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Darby', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Radford', 'Affiliation': 'Manchester Academic Health Science Centre, Manchester Cancer Research Centre, University of Manchester, The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Illidge', 'Affiliation': 'Manchester Academic Health Science Centre, Manchester Cancer Research Centre, University of Manchester, The Christie NHS Foundation Trust, Manchester, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.00408']
1196,33951339,"A Phase 1 Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Trial to Investigate the Effect of Cannabidiol on the CYP1A2 Probe Caffeine in Healthy Subjects.","This pharmacokinetic (PK) drug-interaction trial investigated the effects of repeated dosing of a plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD; Epidiolex in the United States and Epidyolex in Europe; 100 mg/mL oral solution) on caffeine clearance via modulation of cytochrome P450 (CYP) 1A2 activity in healthy adults. In this phase 1 open-label, fixed-sequence trial, all subjects received a single 200 mg caffeine dose and placebo on day 1. Subjects then titrated CBD from 250 mg once daily to 750 mg twice daily between days 3 and 11 and took 750 mg CBD twice daily between days 12 and 27. On day 26, subjects received a single 200-mg caffeine dose with their morning CBD dose. Plasma concentrations of caffeine and its CYP1A2-mediated metabolite, paraxanthine, were determined on days 1 and 26 and PK parameters derived using noncompartmental analysis. Safety was monitored throughout. Sixteen subjects enrolled, and 9 completed treatment. When caffeine was administered with steady-state CBD, caffeine exposure increased by 15% for C max  and 95% for AUC 0-∞  , t max  increased from 1.5 to 3.0 hours, and t 1/2  increased from 5.4 to 10.9 hours compared with caffeine administered with placebo. Under the same conditions, paraxanthine exposure decreased by 22% for C max  and increased by 18% for AUC 0-∞  , t max  increased from 8.0 to 14.0 hours, and t 1/2  increased from 7.2 to 13.7 hours. Overall, there were no unexpected adverse events; diarrhea was most common, and 6 subjects discontinued because of elevated liver transaminases. These data suggest that CBD is an inhibitor of CYP1A2.",2021,"Overall, there were no unexpected adverse events; diarrhea was most common, and 6 subjects discontinued because of elevated liver transaminases.","['Healthy Subjects', 'healthy adults', 'Sixteen subjects enrolled, and 9 completed treatment']","['mL oral solution', 'caffeine', 'placebo', 'caffeine dose and placebo']","['Safety', 'adverse events; diarrhea', 'caffeine clearance via modulation of cytochrome P450 (CYP', '1A2 activity', 'paraxanthine exposure', 'Plasma concentrations of caffeine and its CYP1A2-mediated metabolite, paraxanthine']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0044060', 'cui_str': '1,7-dimethylxanthine'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",16.0,0.0643206,"Overall, there were no unexpected adverse events; diarrhea was most common, and 6 subjects discontinued because of elevated liver transaminases.","[{'ForeName': 'Ching', 'Initials': 'C', 'LastName': 'Thai', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Critchley', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.950']
1197,33951328,Comprehensive Interventions Including Vitamin D Effectively Reduce the Risk of Falls in Elderly Osteoporotic Patients.,"OBJECTIVE


To evaluate the effects of different intervention measures to prevent falls in elderly osteoporotic patients.
METHODS


A randomized controlled trial was conducted in our outpatient ward from August 2014 to September 2015. A total of 420 patients over 60 years of age were assigned to four groups. NA VitD group took 800 mg calcium and 800 IU non-active vitamin D. P-NA VitD group took 800 mg calcium, 800 IU non-active vitamin D, and received physical exercise. A VitD group took 800 mg calcium and 0.5 μg active vitamin D. P-A VitD took 800 mg calcium, 0.5 μg active vitamin D, and received physical exercise. Physical exercise includes guidance in improving muscle strength and balance ability. Short physical performance battery (SPPB), grip strength, modified falls efficacy scale (MFES), blood calcium, and 25-hydroxyl vitamin D were measured before interventions and at 3, 6, and 12 months after interventions. Bone mineral density (BMD) was detected before interventions and at 12 months after interventions. The incidence of falls and fractures, adverse events, and drug reactions were recorded for 12 months.
RESULTS


A total of 420 patients were allocated in the four groups: 98 cases into the NA VitD group (11 males, 87 females), 97 cases into the P-NA VitD group (13 males, 84 females), 99 cases in the A VitD group (15 males, 84 females), and 98 cases into the P-A VitD group (11 males, 87 females). At 6 months after interventions, the SPPB of A VitD group significantly increased from 6.9 ± 1.9 to 8.0 ± 2.4 (P < 0.05), and the SPPB of A VitD group significantly increased from 7.2 ± 2.1 to 8.6 ± 1.7 (P < 0.05). At 6 months after interventions, MFES of P-NA VitD group 7.0 ± 1.6 to 7.6 ± 1.6 (P < 0.05), and MFES of P-A VitD group significantly increased from 6.7 ± 1.6 to 7.5 ± 1.6 (P < 0.05). At 12 months after interventions, SPPB of all groups, grip strength, and MFES of P-NA VitD group, A VitD group, P-A VitD group were significantly improved (P < 0.05). The BMD of lumbar vertebrae of A VitD group significantly increased from 0.742 ± 0.042 to 0.776 ± 0.039, and P-A VitD group significantly increased from 0.743 ± 0.048 to 0.783 ± 0.042 (P < 0.05). No serious adverse events occurred during the 12 months of follow-up.
CONCLUSION


Active vitamin D is better than non-active vitamin D to improve physical ability and the BMD of lumbar vertebrae and reduce the risk of falls.",2021,"The BMD of lumbar vertebrae of A VitD group significantly increased from 0.742 ± 0.042 to 0.776 ± 0.039, and P-A VitD group significantly increased from 0.743 ± 0.048 to 0.783 ± 0.042 (P < 0.05).","['our outpatient ward from August 2014 to September 2015', '420 patients over 60\u2009years of age', 'elderly osteoporotic patients', '420 patients were allocated in the four groups: 98 cases into the NA VitD group (11 males, 87 females), 97 cases into the P-NA VitD group (13 males, 84 females), 99 cases in the A VitD group (15 males, 84 females), and 98 cases into the P-A VitD group (11 males, 87 females', 'Elderly Osteoporotic Patients']","['Vitamin D', 'calcium and 800 IU non-active vitamin D. P-NA VitD group took 800\u2009mg calcium, 800 IU non-active vitamin D, and received physical exercise', 'calcium and 0.5\u2009μg active vitamin D. P-A VitD took 800\u2009mg calcium, 0.5\u2009μg active vitamin D, and received physical exercise', 'Active vitamin D', 'Physical exercise']","['incidence of falls and fractures, adverse events, and drug reactions', 'Short physical performance battery (SPPB), grip strength, modified falls efficacy scale (MFES), blood calcium, and 25-hydroxyl vitamin D', 'muscle strength and balance ability', 'grip strength, and MFES', 'Risk of Falls', 'BMD of lumbar vertebrae', 'serious adverse events', 'Bone mineral density (BMD']","[{'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0919758', 'cui_str': 'Vitamin D measurement'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0919758', 'cui_str': 'Vitamin D measurement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0729820', 'cui_str': 'Blood calcium measurement'}, {'cui': 'C0063146', 'cui_str': 'Hydroxyl Radical'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",420.0,0.0210829,"The BMD of lumbar vertebrae of A VitD group significantly increased from 0.742 ± 0.042 to 0.776 ± 0.039, and P-A VitD group significantly increased from 0.743 ± 0.048 to 0.783 ± 0.042 (P < 0.05).","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Guan', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': 'Department of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Jia', 'Affiliation': 'Department of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Bao', 'Affiliation': 'Department of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qin-Chao', 'Initials': 'QC', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}]",Orthopaedic surgery,['10.1111/os.13009']
1198,33958552,Nurses' Knowledge on Sepsis Related to Mechanical Ventilation: An Intervention Study.,"BACKGROUND


Sepsis is a leading cause of mortality and morbidity worldwide. South African adult public critical care units experience incidences of sepsis on an ongoing basis. Nurses caring for mechanically ventilated adult patients in intensive care units (ICUs) need to base their nursing care on ""surviving sepsis campaign"" (SSC) guidelines to properly manage sepsis. Adequate knowledge on sepsis guidelines remains crucially indicated for nurses as they endeavor to maintain asepsis in critically ill patients.
PURPOSE


This study was conducted to assess the effect of an educational intervention on nurses' knowledge and practices of sepsis in mechanically ventilated adult patients in public ICUs.
METHODS


An intervention study, with quasi-intervention two-group, pretest-posttest design, was used to collect data using a self-administered, structured, pretest and posttest questionnaire designed to measure nurses' knowledge and practices on sepsis related to mechanical ventilation. The study was conducted between June and October 2018. An educational intervention was developed and validated. Five purposively selected public ICUs in the Eastern Cape, South Africa, were selected and assigned to three groups: Intervention Group 1 (ICUs 1 and 2), which received the full intervention (containing a 20-minute PowerPoint presentation, printed materials based on sections of the SSC guidelines, and monitoring visits bimonthly for 3 months); Intervention Group 2 (ICUs 3 and 4; receiving the same as Intervention Group 1 but with no monitoring visits); and the control group (ICU 5; receiving no intervention).
RESULTS


One hundred seventeen nurses completed the questionnaires at pretest, and 94 completed the questionnaires at posttest, producing a response rate of 79% and 80%, respectively. The results revealed a significant knowledge score increase between pretest and posttest for both Intervention Group 2 (53.28 ± 14.39 and 62.18 ± 13.60, respectively; p = .004) and the control group (56.72 ± 13.72 and 70.05 ± 12.40, respectively; p = .001). Similarly, a recommended practice score increase was shown for Intervention Group 2 (58.8 ± 9.63 and 62.80 ± 9.52, respectively), and a significant increase was shown for the control group (56.72 ± 7.54 and 63.29 ± 5.89, respectively; p = .002). Intervention Group 1 showed a detectable but not significant decline in knowledge (57.72 ± 13.99 and 54.61 ± 12.15, respectively) and recommended practice (61.22 ± 8.66 and 60.33 ± 7.83, respectively) scores.
CONCLUSIONS


The availability of SSC guidelines was found to have increased knowledge on sepsis related to mechanical ventilation, although including monitoring visits as part of the educational intervention was not found to have a positive effect on increasing knowledge and practices. Further studies are required to explore factors contributing to improving knowledge and practices on sepsis related to mechanical ventilation and the effect that various educational interventions have in this context.",2021,"Intervention Group 1 showed a detectable but not significant decline in knowledge (57.72 ± 13.99 and 54.61 ± 12.15, respectively) and recommended practice (61.22 ± 8.66 and 60.33 ± 7.83, respectively) scores.
","['mechanically ventilated adult patients in public ICUs', 'critically ill patients', 'Five purposively selected public ICUs in the Eastern Cape, South Africa, were selected and assigned to three groups', 'One hundred seventeen nurses', 'mechanically ventilated adult patients in intensive care units (ICUs', ""Nurses' Knowledge on Sepsis Related to Mechanical Ventilation""]","['full intervention (containing a 20-minute PowerPoint presentation, printed materials based on sections of the SSC guidelines, and monitoring visits bimonthly for 3 months); Intervention Group 2 (ICUs 3 and 4; receiving the same as Intervention Group 1 but with no monitoring visits); and the control group (ICU 5; receiving no intervention', 'educational intervention']","['knowledge score increase', 'response rate', 'knowledge', 'practice score increase', ""nurses' knowledge and practices of sepsis""]","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1278655', 'cui_str': 'SAME AS'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]",5.0,0.0120275,"Intervention Group 1 showed a detectable but not significant decline in knowledge (57.72 ± 13.99 and 54.61 ± 12.15, respectively) and recommended practice (61.22 ± 8.66 and 60.33 ± 7.83, respectively) scores.
","[{'ForeName': 'Emmanuel Zamokwakhe', 'Initials': 'EZ', 'LastName': 'Hlungwane', 'Affiliation': 'BSN, RN, Master Student, Department of Nursing Science, Nelson Mandela University, Port Elizabeth, South Africa.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Ten Ham-Baloyi', 'Affiliation': 'PhD, RN, Research Associate, Faculty of Health Sciences, Nelson Mandela University, Port Elizabeth, South Africa.'}, {'ForeName': 'Portia', 'Initials': 'P', 'LastName': 'Jordan', 'Affiliation': 'PhD, RN, Professor, Faculty of Medicine and Health Sciences, Department of Nursing and Midwifery, Stellenbosch University, South Africa.'}, {'ForeName': 'Benedict Raphael', 'Initials': 'BR', 'LastName': 'Oamen', 'Affiliation': 'BSN, RN, Master Student, Department of Nursing Science, Nelson Mandela University, Port Elizabeth, South Africa.'}]",The journal of nursing research : JNR,['10.1097/JNR.0000000000000434']
1199,33964572,"Alpelisib in combination with everolimus ± exemestane in solid tumours: Phase Ib randomised, open-label, multicentre study.","BACKGROUND AND PURPOSE


Combined mTORC1 inhibition with everolimus (EVE) and phosphatidylinositol 3-kinase catalytic subunit p110α blockade with alpelisib (ALP) has demonstrated synergistic efficacy in preclinical models and supports testing the combination of ALP and EVE in the clinical setting. The primary objective was to determine the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) of ALP in combination with EVE and in combination with EVE and exemestane (EXE) and subsequently assess safety, preliminary efficacy and effect of ALP on the pharmacokinetics of EVE and determine the magnitude of the drug-drug interaction.
PATIENTS AND METHODS


Dose escalation phases were conducted in patients with advanced solid tumours and in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). The dose expansion phase was conducted in patients with pancreatic neuroendocrine tumour and renal cell carcinoma (RCC) (both mechanistic target of rapamycin inhibitor [mTORi]-naive), in patients with mTORi-pretreated solid tumours and in postmenopausal women with HR+, HER2- ABC.
RESULTS


During the doublet escalation phase, dose-limiting toxicities (DLTs) were reported in 5 of 10 (50%) patients: one patient had grade (Gr) 2 hyperglycemia and one patient had Gr 3 diarrhoea in the 300 mg dose group, one patient had Gr 2 hyperglycemia and one patient had Gr 4 hypocalcaemia in the 250 mg dose group, and one patient in the 200 mg dose group had Gr 3 diarrhoea and Gr 3 stomatitis. The combination of ALP 250 mg + EVE 2.5 mg was declared as the MTD/RDE in subjects with advanced solid tumours. In the triplet escalation phase, one patient who received ALP 200 mg + EVE 2.5 mg + EXE 25 mg had a DLT of Gr 3 acute kidney injury. This dose combination was declared as the MTD and RDE in subjects with advanced HR-positive HER2-negative BC. The common adverse events (≥30% patients), occurring across all phases, were hyperglycaemia, stomatitis, diarrhoea, nausea, asthenia, decreased appetite and fatigue. The sixteen-week progression-free survival rate was 52.4% (90% confidence interval [CI]: 32.8, 71.4) in the RCC cohort, 35.3% (90% CI: 16.6, 58.0) in the prior pNET cohort and 30.0% (90% CI: 8.7, 60.7) in the prior mTORi cohort. The pharmacokinetics of 2.5 mg of EVE was largely unchanged in the presence of ALP, independent of the dose (250 mg or 300 mg). There were no clinically relevant drug-drug interactions observed between ALP and EVE.
CONCLUSION


The overall safety profile of ALP with EVE and EXE is manageable and reversible; no unexpected safety signals were noted compared with the individual safety profiles. Pharmacokinetics of ALP, EVE and EXE was largely unchanged in combination with each other.",2021,The overall safety profile of ALP with EVE and EXE is manageable and reversible; no unexpected safety signals were noted compared with the individual safety profiles.,"['patients with pancreatic neuroendocrine tumour and renal cell carcinoma (RCC) (both mechanistic target of rapamycin inhibitor [mTORi]-naive), in patients with mTORi-pretreated solid tumours and in postmenopausal women with HR+, HER2- ABC', 'solid tumours', 'subjects with advanced solid tumours', 'subjects with advanced HR-positive HER2-negative BC', 'patients with advanced solid tumours\xa0and in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC']","['ALP 250\xa0mg\xa0+\xa0EVE 2.5\xa0mg was declared as the MTD/RDE', 'ALP 200\xa0mg\xa0+\xa0EVE 2.5\xa0mg\xa0+\xa0EXE', 'ALP', 'exemestane', 'everolimus (EVE', 'EVE', 'EVE and exemestane (EXE', 'alpelisib (ALP']","['progression-free survival rate', 'hyperglycaemia, stomatitis, diarrhoea, nausea, asthenia, decreased appetite\xa0and fatigue', 'Pharmacokinetics of ALP, EVE and EXE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242363', 'cui_str': 'Pancreatic endocrine tumor'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C4055478', 'cui_str': 'alpelisib'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C5140593', 'cui_str': 'alpelisib 200 MG [Piqray]'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4055478', 'cui_str': 'alpelisib'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}]",,0.113988,The overall safety profile of ALP with EVE and EXE is manageable and reversible; no unexpected safety signals were noted compared with the individual safety profiles.,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'Department of Oncology and Hematology, University of Milano, Milan, Italy; European Intitute of Oncology, IEO, IRCCS, Milan, Italy. Electronic address: giuseppe.curigliano@ieo.it.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Jhaveri', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, NY, USA.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Highlands Oncology Group, AR, USA.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Tortora', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fazio', 'Affiliation': 'European Intitute of Oncology, IEO, IRCCS, Milan, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Maur', 'Affiliation': 'University Hospital of Modena, MO, Italy.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Hubner', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Lahner', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Donnet', 'Affiliation': 'Novartis Pharmaceuticals, NJ, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Ajipa', 'Affiliation': 'Novartis Pharmaceuticals, NJ, USA.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Novartis Pharmaceuticals, NJ, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Blumenstein', 'Affiliation': 'Novartis Pharmaceuticals, NJ, USA.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Andre', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.03.042']
1200,33974020,Effect of an Internet-Delivered Stepped-Care Program vs In-Person Cognitive Behavioral Therapy on Obsessive-Compulsive Disorder Symptoms in Children and Adolescents: A Randomized Clinical Trial.,"Importance


In most countries, young people with obsessive-compulsive disorder have limited access to specialist cognitive behavioral therapy (CBT), a first-line treatment.
Objective


To investigate whether internet-delivered CBT implemented in a stepped-care model is noninferior to in-person CBT for pediatric obsessive-compulsive disorder.
Design, Setting and Participants


A randomized clinical noninferiority trial conducted at 2 specialist child and adolescent mental health clinics in Sweden. Participants included 152 individuals aged 8 to 17 years with obsessive-compulsive disorder. Enrollment began in October 2017 and ended in May 2019. Follow-up ended in April 2020.
Interventions


Participants randomized to the stepped-care group (n = 74) received internet-delivered CBT for 16 weeks. Nonresponders at the 3-month follow-up were then offered a course of traditional face-to-face treatment. Participants randomized to the control group (n = 78) immediately received in-person CBT for 16 weeks. Nonresponders at the 3-month follow-up received additional face-to-face treatment.
Main Outcomes and Measures


The primary outcome was the masked assessor-rated Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score at the 6-month follow-up. The scale includes 10 items rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total score range of 0 to 40, with higher scores indicating greater severity. Assessors were masked to treatment allocation at pretreatment, posttreatment, 3-month follow-up, and 6-month follow-up assessments. The predefined noninferiority margin was 4 points on the CY-BOCS.
Results


Among the 152 randomized participants (mean age, 13.4 years; 94 [62%] females), 151 (99%) completed the trial. At the 3-month follow-up, 34 participants (46%) in the stepped-care group and 23 (30%) in the in-person CBT group were nonresponders. At the 6-month follow-up, the CY-BOCS score was 11.57 points in the stepped-care group vs 10.57 points in the face-to-face treatment group, corresponding to an estimated mean difference of 0.91 points ([1-sided 97.5% CI, -∞ to 3.28]; P for noninferiority = .02). Increased anxiety (30%-36%) and depressive symptoms (20%-28%) were the most frequently reported adverse events in both groups. There were 2 unrelated serious adverse events (1 in each group).
Conclusions and Relevance


Among children and adolescents with obsessive-compulsive disorder, treatment with an internet-delivered CBT program followed by in-person CBT if necessary compared with in-person CBT alone resulted in a noninferior difference in symptoms at the 6-month follow-up. Further research is needed to understand the durability and generalizability of these findings.
Trial Registration


ClinicalTrials.gov Identifier: NCT03263546.",2021,Increased anxiety (30%-36%) and depressive symptoms (20%-28%) were the most frequently reported adverse events in both groups.,"['152 randomized participants (mean age, 13.4 years; 94 [62%] females), 151 (99%) completed the trial', 'Participants included 152 individuals aged 8 to 17 years with obsessive-compulsive disorder', '2 specialist child and adolescent mental health clinics in Sweden', 'children and adolescents with obsessive-compulsive disorder', 'Children and Adolescents', 'young people with obsessive-compulsive disorder']","['control group (n\u2009=\u200978) immediately received in-person CBT', 'specialist cognitive behavioral therapy (CBT', 'stepped-care group (n\u2009=\u200974) received internet-delivered CBT', 'internet-delivered CBT', 'Internet-Delivered Stepped-Care Program vs In-Person Cognitive Behavioral Therapy']","['Obsessive-Compulsive Disorder Symptoms', 'adverse events', 'depressive symptoms', 'Increased anxiety', ""masked assessor-rated Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score"", 'serious adverse events', 'CY-BOCS score']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",152.0,0.197465,Increased anxiety (30%-36%) and depressive symptoms (20%-28%) were the most frequently reported adverse events in both groups.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Aspvall', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Melin', 'Affiliation': 'Institute Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Norlin', 'Affiliation': 'Region Västra Götaland, Department of Child and Adolescent Psychiatry, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Eriksson', 'Affiliation': 'Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vigerland', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Maral', 'Initials': 'M', 'LastName': 'Jolstedt', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Silverberg-Mörse', 'Affiliation': 'Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Wallin', 'Affiliation': 'Region Västra Götaland, Department of Child and Adolescent Psychiatry, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Sampaio', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala Universitet, Uppsala, Sweden.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Feldman', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala Universitet, Uppsala, Sweden.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Divison of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Lenhard', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mataix-Cols', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Serlachius', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}]",JAMA,['10.1001/jama.2021.3839']
1201,33974019,Effect of a Digital Intervention on Depressive Symptoms in Patients With Comorbid Hypertension or Diabetes in Brazil and Peru: Two Randomized Clinical Trials.,"Importance


Depression is a leading contributor to disease burden globally. Digital mental health interventions can address the treatment gap in low- and middle-income countries, but the effectiveness in these countries is unknown.
Objective


To investigate the effectiveness of a digital intervention in reducing depressive symptoms among people with diabetes and/or hypertension.
Design, Setting, and Participants


Participants with clinically significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score ≥10) who were being treated for hypertension and/or diabetes were enrolled in a cluster randomized clinical trial (RCT) at 20 sites in São Paulo, Brazil (N=880; from September 2016 to September 2017; final follow-up, April 2018), and in an individual-level RCT at 7 sites in Lima, Peru (N=432; from January 2017 to September 2017; final follow-up, March 2018).
Interventions


An 18-session, low-intensity, digital intervention was delivered over 6 weeks via a provided smartphone, based on behavioral activation principles, and supported by nurse assistants (n = 440 participants in 10 clusters in São Paulo; n = 217 participants in Lima) vs enhanced usual care (n = 440 participants in 10 clusters in São Paulo; n = 215 participants in Lima).
Main Outcomes and Measures


The primary outcome was a reduction of at least 50% from baseline in PHQ-9 scores (range, 0-27; higher score indicates more severe depression) at 3 months. Secondary outcomes included a reduction of at least 50% from baseline PHQ-9 scores at 6 months.
Results


Among 880 patients cluster randomized in Brazil (mean age, 56.0 years; 761 [86.5%] women) and 432 patients individually randomized in Peru (mean age, 59.7 years; 352 [81.5%] women), 807 (91.7%) in Brazil and 426 (98.6%) in Peru completed at least 1 follow-up assessment. The proportion of participants in São Paulo with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 40.7% (159/391 participants) in the digital intervention group vs 28.6% (114/399 participants) in the enhanced usual care group (difference, 12.1 percentage points [95% CI, 5.5 to 18.7]; adjusted odds ratio [OR], 1.6 [95% CI, 1.2 to 2.2]; P = .001). In Lima, the proportion of participants with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 52.7% (108/205 participants) in the digital intervention group vs 34.1% (70/205 participants) in the enhanced usual care group (difference, 18.6 percentage points [95% CI, 9.1 to 28.0]; adjusted OR, 2.1 [95% CI, 1.4 to 3.2]; P < .001). At 6-month follow-up, differences across groups were no longer statistically significant.
Conclusions and Relevance


In 2 RCTs of patients with hypertension or diabetes and depressive symptoms in Brazil and Peru, a digital intervention delivered over a 6-week period significantly improved depressive symptoms at 3 months when compared with enhanced usual care. However, the magnitude of the effect was small in the trial from Brazil and the effects were not sustained at 6 months.
Trial Registration


ClinicalTrials.gov: NCT02846662 (São Paulo) and NCT03026426 (Lima).",2021,"At 6-month follow-up, differences across groups were no longer statistically significant.
","['880 patients cluster randomized in Brazil (mean age, 56.0 years; 761 [86.5%] women) and 432 patients individually randomized in Peru (mean age, 59.7 years; 352 [81.5%] women), 807 (91.7%) in Brazil and 426 (98.6%) in Peru completed at least 1 follow-up assessment', 'Participants\n\n\nParticipants with clinically significant depressive symptoms (Patient Health Questionnaire-9', 'patients with hypertension or diabetes and depressive symptoms in Brazil and Peru', 'PHQ-9] score ≥10) who were being treated for hypertension and/or diabetes', 'Patients With Comorbid Hypertension or Diabetes in Brazil and Peru', 'people with diabetes and/or hypertension']","['Digital Intervention', 'digital intervention', 'nurse assistants (n\u2009=\u2009440 participants in 10 clusters in São Paulo; n\u2009=\u2009217 participants in Lima) vs enhanced usual care (n\u2009=\u2009440 participants in 10 clusters in São Paulo; n\u2009=\u2009215 participants in Lima', 'Digital mental health interventions']","['PHQ-9 score', 'reduction of at least 50% from baseline in PHQ-9 scores', 'reduction of at least 50% from baseline PHQ-9 scores', 'severe depression', 'depressive symptoms', 'Depressive Symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.326494,"At 6-month follow-up, differences across groups were no longer statistically significant.
","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Centre for Global Mental Health, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Paulo Rossi', 'Initials': 'PR', 'LastName': 'Menezes', 'Affiliation': 'Population Mental Health Research Centre, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Heloísa Garcia', 'Initials': 'HG', 'LastName': 'Claro', 'Affiliation': 'Population Mental Health Research Centre, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lena R', 'Initials': 'LR', 'LastName': 'Brandt', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Daley', 'Affiliation': 'Population Mental Health Research Centre, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Julieta', 'Initials': 'J', 'LastName': 'Quayle', 'Affiliation': 'Population Mental Health Research Centre, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Diez-Canseco', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Vera Cruz', 'Affiliation': 'Population Mental Health Research Centre, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Toyama', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Aschar', 'Affiliation': 'Population Mental Health Research Centre, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Hidalgo-Padilla', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Hellen', 'Initials': 'H', 'LastName': 'Martins', 'Affiliation': 'Population Mental Health Research Centre, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cavero', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Rocha', 'Affiliation': 'Population Mental Health Research Centre, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Scotton', 'Affiliation': 'Population Mental Health Research Centre, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ivan F', 'Initials': 'IF', 'LastName': 'de Almeida Lopes', 'Affiliation': 'Federal University of ABC, Engineering, Modeling and Applied Social Sciences Center (CECS), Santo André, Brazil.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Begale', 'Affiliation': 'Center for Behavioral Intervention Technologies, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Center for Behavioral Intervention Technologies, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",JAMA,['10.1001/jama.2021.4348']
1202,33976352,Carbon nanoparticle suspension could help get a more accurate nodal staging for patient with rectal cancer.,"This study aimed to evaluate whether carbon nanoparticles could improve the accuracy of nodal staging in colorectal cancer (CRC). We performed a randomized controlled trial with CRC at the department of general surgery, the affiliated hospital of Nanjing University Medical School. A total of 160 patients were recruited in this research and 132 patients were included in the safety analyses. Among these patients, 72 cases were classified into control group and 60 cases into study group. The mean number of lymph nodes harvested from patients in study group was 19.3 ± 6.7 (range from 4 to 38), which was higher than that in control group (15.1 ± 5.7 (range from 3 to 29)) (p < 0.001). The mean number of positive lymph nodes got from patients in study group was 1.7 ± 3.5 (range from 0 to 22), which was also higher than that in control group (0.7 ± 1.4 (range from 0 to 7)) (p = 0.045). In study group, there were 30 patients (50%) proved to be N0, and remaining 30 patients (50%) were N1 or N2. However, 50 patients (69.4%) were N0 and 22 patients (30.6%) were N1 or N2 in control group. The rate of N0 in control group was significantly higher than that in study group (p = 0.023). Injecting carbon nanoparticle suspension could get a more accurate nodal staging to receive enough chemoradiotherapy, improving prognosis. Besides, injecting carbon nanoparticles suspension at four points 5 cm, 10 cm, 15 cm and 20 cm away from the anus by ""sandwich"" method was a new try.Trial registration: This study was registered with ClinicalTrials.gov, number ChiCTR1900025127 on 12/8/2019.",2021,The rate of N0 in control group was significantly higher than that in study group (p = 0.023).,"['colorectal cancer (CRC', 'department of general surgery, the affiliated hospital of Nanjing University Medical School', 'A total of 160 patients were recruited in this research and 132 patients were included in the safety analyses', 'patient with rectal cancer']","['carbon nanoparticles', 'CRC', 'Carbon nanoparticle suspension']","['rate of N0', 'mean number of positive lymph nodes', 'mean number of lymph nodes']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]",160.0,0.168739,The rate of N0 in control group was significantly higher than that in study group (p = 0.023).,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ge', 'Affiliation': ""Gastrointestinal Center, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Gastrointestinal Center, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Wen-Jia', 'Initials': 'WJ', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xiao-Qi', 'Initials': 'XQ', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xiang-Shan', 'Initials': 'XS', 'LastName': 'Fan', 'Affiliation': ""Department of Pathology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Shao', 'Affiliation': ""Gastrointestinal Center, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': ""Gastrointestinal Center, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Wen-Xian', 'Initials': 'WX', 'LastName': 'Guan', 'Affiliation': ""Gastrointestinal Center, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China. medguanwx@163.com.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""Gastrointestinal Center, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China. 331812195@qq.com.""}]",Scientific reports,['10.1038/s41598-021-89541-5']
1203,33981301,"Islet Autoimmunity in Adults With Impaired Glucose Tolerance and Recently Diagnosed, Treatment Naïve Type 2 Diabetes in the Restoring Insulin SEcretion (RISE) Study.","The presence of islet autoantibodies and islet reactive T cells (T+) in adults with established type 2 diabetes (T2D) have been shown to identify those patients with more severe β-cell dysfunction. However, at what stage in the progression toward clinical T2D does islet autoimmunity emerge as an important component influencing β-cell dysfunction? In this ancillary study to the Restoring Insulin SEcretion (RISE) Study, we investigated the prevalence of and association with β-cell dysfunction of T+ and autoantibodies to the 65 kDa glutamic acid decarboxylase antigen (GADA) in obese pre-diabetes adults with impaired glucose tolerance (IGT) and recently diagnosed treatment naïve (Ndx) T2D. We further investigated the effect of 12 months of RISE interventions (metformin or liraglutide plus metformin, or with 3 months of insulin glargine followed by 9 months of metformin or placebo) on islet autoimmune reactivity. We observed GADA(+) in 1.6% of NdxT2D and 4.6% of IGT at baseline, and in 1.6% of NdxT2D and 5.3% of IGT at 12 months, but no significant associations between GADA(+) and β-cell function. T(+) was observed in 50% of NdxT2D and 60.4% of IGT at baseline, and in 68.4% of NdxT2D and 83.9% of IGT at 12 months. T(+) NdxT2D were observed to have significantly higher fasting glucose ( p  = 0.004), and 2 h glucose ( p  = 0.0032), but significantly lower steady state C-peptide (sscpep,  p  = 0.007) compared to T(-) NdxT2D. T(+) IGT participants demonstrated lower but not significant ( p  = 0.025) acute (first phase) C-peptide response to glucose (ACPRg) compared to T(-) IGT. With metformin treatment, T(+) participants were observed to have a significantly lower Hemoglobin A1c (HbA1c,  p  = 0.002) and fasting C-peptide ( p  = 0.002) compared to T(-), whereas T(+) treated with liraglutide + metformin had significantly lower sscpep ( p  = 0.010) compared to T(-) participants. In the placebo group, T(+) participants demonstrated significantly lower ACPRg ( p  = 0.001) compared to T(-) participants. In summary, T(+) were found in a large percentage of obese pre-diabetes adults with IGT and in recently diagnosed T2D. Moreover, T(+) were significantly correlated with treatment effects and β-cell dysfunction. Our results demonstrate that T(+) are an important component in T2D.",2021,"In the placebo group, T(+) participants demonstrated significantly lower ACPRg ( p  = 0.001) compared to T(-) participants.","['Adults With Impaired Glucose Tolerance and Recently Diagnosed, Treatment Naïve Type 2 Diabetes in the Restoring Insulin SEcretion (RISE) Study', 'adults with established type 2 diabetes (T2D', 'obese pre-diabetes adults with IGT and in recently diagnosed T2D', 'obese pre-diabetes adults with impaired glucose tolerance (IGT) and recently diagnosed treatment naïve']","['65 kDa glutamic acid decarboxylase antigen (GADA', 'T', 'liraglutide + metformin', 'metformin', 'RISE interventions (metformin or liraglutide plus metformin, or with 3 months of insulin glargine', 'metformin or placebo', 'placebo']","['Restoring Insulin SEcretion (RISE', 'steady state C-peptide (sscpep,  p  = 0.007) compared to T(-) NdxT2D. T', 'fasting glucose', 'islet autoantibodies and islet reactive T cells (T', 'fasting C-peptide', 'islet autoimmune reactivity', 'ACPRg', 'Hemoglobin A1c']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C1532717', 'cui_str': 'kDa'}, {'cui': 'C0017785', 'cui_str': 'Glutamate decarboxylase'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0443146', 'cui_str': 'Autoimmune reaction'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.175118,"In the placebo group, T(+) participants demonstrated significantly lower ACPRg ( p  = 0.001) compared to T(-) participants.","[{'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Brooks-Worrell', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Ashley H', 'Initials': 'AH', 'LastName': 'Tjaden', 'Affiliation': 'Biostatistics Center, Milken School of Public Health, George Washington University Biostatistics Center, Rockville, MD, United States.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'Biostatistics Center, Milken School of Public Health, George Washington University Biostatistics Center, Rockville, MD, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Palomino', 'Affiliation': 'Seattle Institute for Biochemical and Clinical Research, Seattle, WA, United States.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""Department of Medicine, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, Pittsburgh, PA, United States.""}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Richard L. Roudebush Veterans Affairs Medical Center, Indianapolis, IN, United States.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'University of Southern California Keck School of Medicine/Kaiser Permanente Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus/Children's Hospital Colorado, Aurora, CO, United States.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Atkinson', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System, Seattle, WA, United States.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barengolts', 'Affiliation': 'University of Chicago Clinical Research Center and Jesse Brown Veterans Affairs Medical Center, Chicago, IL, United States.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Palmer', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in immunology,['10.3389/fimmu.2021.640251']
1204,33986030,"Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: a randomised, placebo-controlled, crossover phase 2a study.","ATP acting  via  P2X3 receptors is an important mediator of refractory chronic cough (RCC). This phase 2a double-blinded crossover study assessed the safety, tolerability and efficacy of eliapixant (BAY 1817080), a selective P2X3 receptor antagonist, in adults with RCC attending specialist centres.In period A, patients received placebo for 2 weeks then eliapixant 10 mg for 1 week. In period B, patients received eliapixant 50, 200 and 750 mg twice daily for 1 week per dose level. Patients were randomised 1:1 to period A-B (n=20) or B-A (n=20). The primary efficacy endpoint was change in cough frequency assessed over 24 h (VitaloJAK). Primary safety endpoint was frequency and severity of adverse events (AEs).Thirty-seven patients completed randomised therapy. Mean cough frequency fell by 17.4%  versus  baseline with placebo. Eliapixant reduced cough frequency at doses ≥50 mg (reduction  versus  placebo at 750 mg, 25%: 90% confidence interval, 11.5-36.5%; p=0.002). Doses ≥50 mg also significantly reduced cough severity. AEs, mostly mild or moderate, were reported in 65% of patients with placebo and 41-49% receiving eliapixant. Cumulative rates of taste-related AEs were 3% with placebo and 5-21% with eliapixant: all were mild.Selective P2X3 antagonism with eliapixant significantly reduced cough frequency and severity, confirming this as a viable therapeutic pathway for RCC. Taste-related side-effects were lower at therapeutic doses than with the less selective P2X3 antagonist gefapixant. Selective P2X3 antagonism appears to be a novel therapeutic approach for RCC.",2021,Taste-related side-effects were lower at therapeutic doses than with the less selective P2X3 antagonist gefapixant.,['adults with RCC attending specialist centres'],"['placebo', 'eliapixant']","['frequency and severity of adverse events', 'Mean cough frequency fell', 'cough severity', 'cough frequency assessed over 24\u2005h (VitaloJAK', 'Cumulative rates of taste-related AEs', 'safety, tolerability and efficacy', 'Taste-related side-effects', 'Eliapixant reduced cough frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.185238,Taste-related side-effects were lower at therapeutic doses than with the less selective P2X3 antagonist gefapixant.,"[{'ForeName': 'Alyn', 'Initials': 'A', 'LastName': 'Morice', 'Affiliation': 'Respiratory Research Group, Hull York Medical School, University of Hull, Hull, UK a.h.morice@hull.ac.uk.'}, {'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Manchester University NHS Foundation Trust, and Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Lorcan', 'Initials': 'L', 'LastName': 'McGarvey', 'Affiliation': ""Wellcome Wolfson Institute of Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Surinder S', 'Initials': 'SS', 'LastName': 'Birring', 'Affiliation': ""Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College Hospital, London, UK.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Parker', 'Affiliation': 'North Tyneside Hospital, Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Institute of Applied Health Research and Population Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Gashaw', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Lueder', 'Initials': 'L', 'LastName': 'Fels', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Francke', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Friedrich', 'Affiliation': 'Bayer AG, Berlin, Germany.'}]",The European respiratory journal,['10.1183/13993003.04240-2020']
1205,33991228,"Evaluation of potential metabolomic-based biomarkers of protein, carbohydrate and fat intakes using a controlled feeding study.","PURPOSE


Objective biomarkers of dietary exposure are needed to establish reliable diet-disease associations. Unfortunately, robust biomarkers of macronutrient intakes are scarce. We aimed to assess the utility of serum, 24-h urine and spot urine high-dimensional metabolites for the development of biomarkers of daily intake of total energy, protein, carbohydrate and fat, and the percent of energy from these macronutrients (%E).
METHODS


A 2-week controlled feeding study mimicking the participants' habitual diets was conducted among 153 postmenopausal women from the Women's Health Initiative (WHI). Fasting serum metabolomic profiles were analyzed using a targeted liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay for aqueous metabolites and a direct-injection-based quantitative lipidomics platform. Urinary metabolites were analyzed using  1 H nuclear magnetic resonance (NMR) spectroscopy at 800 MHz and by untargeted gas chromatography-mass spectrometry (GC-MS). Variable selection was performed to build prediction models for each dietary variable.
RESULTS


The highest cross-validated multiple correlation coefficients (CV-R 2 ) for protein intake (%E) and carbohydrate intake (%E) using metabolites only were 36.3 and 37.1%, respectively. With the addition of established dietary biomarkers (doubly labeled water for energy and urinary nitrogen for protein), the CV-R 2  reached 55.5% for energy (kcal/d), 52.0 and 45.0% for protein (g/d, %E), 55.9 and 37.0% for carbohydrate (g/d, %E).
CONCLUSION


Selected panels of serum and urine metabolites, without the inclusion of doubly labeled water and urinary nitrogen biomarkers, give a reliable and robust prediction of daily intake of energy from protein and carbohydrate.",2021,"The highest cross-validated multiple correlation coefficients (CV-R 2 ) for protein intake (%E) and carbohydrate intake (%E) using metabolites only were 36.3 and 37.1%, respectively.","['participants', ""153 postmenopausal women from the Women's Health Initiative (WHI""]",['habitual diets'],"['carbohydrate intake', 'Fasting serum metabolomic profiles', 'Urinary metabolites']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",153.0,0.0295182,"The highest cross-validated multiple correlation coefficients (CV-R 2 ) for protein intake (%E) and carbohydrate intake (%E) using metabolites only were 36.3 and 37.1%, respectively.","[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Biostatistics, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'G A Nagana', 'Initials': 'GAN', 'LastName': 'Gowda', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Lesley F', 'Initials': 'LF', 'LastName': 'Tinker', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Shirley A A', 'Initials': 'SAA', 'LastName': 'Beresford', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zilber School of Public Health, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bettcher', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pepin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Danijel', 'Initials': 'D', 'LastName': 'Djukovic', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Haiwei', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Barding', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. jlampe@fredhutch.org.'}]",European journal of nutrition,['10.1007/s00394-021-02577-1']
1206,34389772,Early decompressive hemicraniectomy in thrombolyzed acute ischemic stroke patients from the international ENCHANTED trial.,"Decompressive hemicraniectomy (DHC) can improve outcomes for patients with severe forms of acute ischemic stroke (AIS), but the evidence is mainly derived from non-thrombolyzed patients. We aimed to determine the characteristics and outcomes of early DHC in thrombolyzed AIS participants of the international Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED). Post-hoc analyses of ENCHANTED, an international, partial-factorial, open, blinded outcome-assessed, controlled trial in 4557 thrombolysis-eligible AIS patients randomized to low- versus standard-dose intravenous alteplase (Arm A, n = 2350), intensive versus guideline-recommended blood pressure control (Arm B, n = 1280), or both (Arms A + B, n = 947). Logistic regression models were used to identify baseline variables associated with DHC, with inverse probability of treatment weights employed to eliminate baseline imbalances between those with and without DHC. Logistic regression was also used to determine associations of DHC and clinical outcomes of death/disability, major disability, and death (defined by scores 2-6, 3-5, and 6, respectively, on the modified Rankin scale) at 90 days post-randomization. There were 95 (2.1%) thrombolyzed AIS patients who underwent DHC, who were significantly younger, of non-Asian ethnicity, and more likely to have had prior lipid-lowering treatment and severe neurological impairment from large vessel occlusion than other patients. DHC patients were more likely to receive other management interventions and have poor functional outcomes than non-DHC patients, with no relation to different doses of intravenous alteplase. Compared to other thrombolyzed AIS patients, those who received DHC had a poor prognosis from more severe disease despite intensive in-hospital management.",2021,"DHC patients were more likely to receive other management interventions and have poor functional outcomes than non-DHC patients, with no relation to different doses of intravenous alteplase.","['thrombolyzed acute ischemic stroke patients', 'thrombolyzed AIS participants of the international Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED', 'DHC patients', '4557 thrombolysis-eligible AIS patients randomized to', 'patients with severe forms of acute ischemic stroke (AIS']","['decompressive hemicraniectomy', 'DHC', 'Decompressive hemicraniectomy (DHC', 'low- versus standard-dose intravenous alteplase (Arm A, n\u2009=\u20092350), intensive versus guideline-recommended blood pressure control']","['death/disability, major disability, and death']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",4557.0,0.0387256,"DHC patients were more likely to receive other management interventions and have poor functional outcomes than non-DHC patients, with no relation to different doses of intravenous alteplase.","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': ""Huaxi MR Research Center (HMRRC), Department of Radiology, West China Hospital, Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': ""Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Zeljka', 'Initials': 'Z', 'LastName': 'Calic', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Mair', 'Affiliation': 'Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Wardlaw', 'Affiliation': 'Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia. canderson@georgeinstitute.org.au.'}]",Scientific reports,['10.1038/s41598-021-96087-z']
1207,34389753,"Relative absorption of silicon from different formulations of dietary supplements: a pilot randomized, double-blind, crossover post-prandial study.","The purpose of the present study was to compare the relative absorption of a new powder presentation of silicon (Si) as orthosilicic acid with maltodextrin (Orgono Powder) compared to usual Si liquid presentations as orthosilicic acid with Equisetum arvense and Rosmarinus officinalis (G5 Siliplant) and orthosilicic acid with aloe vera (G7 Aloe). All dietary supplements were administered at the same Si oral dose (21.6 mg) in a randomized, double-blind, crossover post-prandial study conducted in 5 healthy men. Urine was collected at baseline and over the 6-h post-dose period in 2 separate 3-h collections for the analysis of Si concentration, which was conducted by inductively coupled plasma optical emission spectrometry as the gold standard method. No significant differences in total urinary Si excretion were found after the intake of these 3 dietary supplements; 34.6%, 32.4% and 27.2% of the ingested Si from G7 Aloe, G5 Siliplant and Orgono Powder, respectively, was excreted in urine over the 6-h follow-up period. The 3 different oral Si formulations tested, in powder and liquid presentations, provide highly bioavailable Si and present an equivalent relative absorption in healthy humans.",2021,"No significant differences in total urinary Si excretion were found after the intake of these 3 dietary supplements; 34.6%, 32.4% and 27.2% of the ingested Si from G7 Aloe, G5 Siliplant and Orgono Powder, respectively, was excreted in urine over the 6-h follow-up period.","['5 healthy men', 'healthy humans']","['silicon (Si) as orthosilicic acid with maltodextrin (Orgono Powder', 'dietary supplements', 'orthosilicic acid with aloe vera (G7 Aloe']",['total urinary Si excretion'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0037107', 'cui_str': 'Silicon'}, {'cui': 'C4020396', 'cui_str': 'orthosilicic acid'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0002168', 'cui_str': 'Aloe'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037107', 'cui_str': 'Silicon'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",5.0,0.268521,"No significant differences in total urinary Si excretion were found after the intake of these 3 dietary supplements; 34.6%, 32.4% and 27.2% of the ingested Si from G7 Aloe, G5 Siliplant and Orgono Powder, respectively, was excreted in urine over the 6-h follow-up period.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Boqué', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició I Salut, Av. de La Universitat, 43204, Reus, Spain.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Valls', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició I Salut, Av. de La Universitat, 43204, Reus, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pedret', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició I Salut, Av. de La Universitat, 43204, Reus, Spain. anna.pedret@eurecat.org.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Puiggrós', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició I Salut, Av. de La Universitat, 43204, Reus, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Arola', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició I Salut, Av. de La Universitat, 43204, Reus, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Solà', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició I Salut, Av. de La Universitat, 43204, Reus, Spain.'}]",Scientific reports,['10.1038/s41598-021-95220-2']
1208,33970657,Insight as a mechanism of change in dynamic therapy for major depressive disorder.,"This study aimed to investigate change in insight into maladaptive interpersonal patterns over the course of psychotherapy, as well as the specificity of insight as a change mechanism in dynamic treatments. A total of 100 patients received up to 16 sessions of either cognitive or dynamic therapy for major depressive disorder in a randomized clinical trial. Assessments of insight (Insight into Conflictual Relationship Patterns scale) and depression severity (Hamilton Depression Inventory) took place at the beginning of treatment, at month 2, and month 5. Patient insight significantly improved over the course of dynamic treatments. Gains in insight from the beginning to month 2 of treatment were a significant predictor of decreases of depressive symptoms from month 2 to month 5 of treatment in the dynamic, but not in the cognitive treatment group, despite a nonsignificant interaction. Results provide support for insight as a change factor in dynamic therapies. Better self-understanding of dysfunctional interaction patterns could help patients to find more adaptive ways of behaving, to form more satisfying relationships, and to improve their depression. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Gains in insight from the beginning to month 2 of treatment were a significant predictor of decreases of depressive symptoms from month 2 to month 5 of treatment in the dynamic, but not in the cognitive treatment group, despite a nonsignificant interaction.","['major depressive disorder', '100 patients']",['cognitive or dynamic therapy'],"['depressive symptoms', 'Assessments of insight (Insight into Conflictual Relationship Patterns scale) and depression severity (Hamilton Depression Inventory']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",100.0,0.0765239,"Gains in insight from the beginning to month 2 of treatment were a significant predictor of decreases of depressive symptoms from month 2 to month 5 of treatment in the dynamic, but not in the cognitive treatment group, despite a nonsignificant interaction.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Jennissen', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Heidelberg University.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Connolly Gibbons', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Crits-Christoph', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Schauenburg', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Heidelberg University.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Dinger', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Heidelberg University.'}]",Journal of counseling psychology,['10.1037/cou0000554']
1209,33978502,Reasoned Action Approach Correlates of Fruit and Vegetable Diet Among African American Men Living With HIV: A Cross-Sectional Study.,"Epidemiological evidence of the protective role of fruits and vegetables for a host of chronic health conditions is well-documented. However, there is a dearth of studies examining predictors of fruit and vegetable intake among African American men living with HIV. We report secondary analyses-multiple regression and logistic regression models fitted to examine the strength of the relationships between the reasoned action approach constructs; namely, attitudes, subjective norms, descriptive norms, self-efficacy and intention to consume fruits and vegetables, and self-reported adherence to 5-A-DAY guidelines. We used baseline data from a randomized controlled trial of a physical activity intervention trial with 302 African American men aged 40 years or older ( M  = 53.9;  SD  = 7.2) living with HIV. Attitudes, subjective norms, descriptive norms, and self-efficacy were positively associated with intention to meet 5-A-DAY guidelines. More positive attitudes toward 5-A-DAY guidelines were associated with higher odds of meeting 5-A-DAY guidelines. More positive attitudes and self-efficacy were also positively associated with meeting the guidelines for intake of vegetable servings and fruit-and-vegetable servings combined. To increase fruit and vegetable intake among African American men living with HIV, interventions should be tailored to address the perceived benefits of consumption.",2021,More positive attitudes and self-efficacy were also positively associated with meeting the guidelines for intake of vegetable servings and fruit-and-vegetable servings combined.,"['African American Men Living With HIV', '302 African American men aged 40 years or older ( M  = 53.9;  SD  = 7.2) living with HIV', 'African American men living with HIV']","['fruits and vegetables', 'physical activity intervention', 'Fruit and Vegetable Diet']","['fruit and vegetable intake', 'Attitudes, subjective norms, descriptive norms, and self-efficacy', 'positive attitudes and self-efficacy']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517857', 'cui_str': '7.2'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}]",302.0,0.0343759,More positive attitudes and self-efficacy were also positively associated with meeting the guidelines for intake of vegetable servings and fruit-and-vegetable servings combined.,"[{'ForeName': 'Terri-Ann', 'Initials': 'TA', 'LastName': 'Kelly', 'Affiliation': 'Rutgers University, Camden, NJ, USA.'}, {'ForeName': 'Soojong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Loretta S', 'Initials': 'LS', 'LastName': 'Jemmott', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Icard', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Chittamuru', 'Affiliation': 'University of California, Merced, CA, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Jemmott', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/10901981211011938']
1210,33983111,Implementing a sleep technician-supervised and personalized APAP interface fitting session prior to initiation of home APAP therapy improves adherence in patients with obstructive sleep apnea.,"STUDY OBJECTIVES


Home automatic positive airway pressure (APAP) therapy is becoming a mainstay treatment of obstructive sleep apnea. It is typically prescribed without any prior supervised titration. Initial experience of APAP treatment dictates subsequent use. Discomfort related to the APAP interface contributes to poor APAP adherence.
METHODS


After obtaining institutional review board approval, 156 adult patients newly diagnosed with obstructive sleep apnea were prospectively randomized into 2 groups (group A and group B). Group A received a 30-minute personalized interface/mask fitting session supervised by a certified sleep technician, during which APAP therapy was simulated and patients were educated on proper use. Patients sampled different interfaces to address any issues with comfort. Group B received usual care where patients obtained an interface through durable medical equipment suppliers. Primary endpoints included percent APAP usage (number of days APAP was used for ≥ 4 hours divided by 30 days) and APAP usage (number of days APAP was used for any duration) during the initial 30 days of home APAP therapy. Interface-associated air leak served as the secondary endpoint.
RESULTS


Mean percent APAP usage was higher in group A compared to group B (78.4% vs 67.8%;  P  = .04). On average, group A utilized the APAP machine on more days compared to group B (27 vs 24 days;  P  = .01). APAP interface associated air leak was lower in group A compared to group B (14.9 vs 21.1 l/min;  P  = .03).
CONCLUSIONS


Our findings demonstrate that implementing a personalized interface fitting session supervised by a sleep technician improves APAP adherence.
CITATION


Syed Z, Mehta I, Hella JR, Barber K, Khorfan F. Implementing a sleep technician-supervised and personalized APAP interface fitting session prior to initiation of home APAP therapy improves adherence in patients with obstructive sleep apnea.  J Clin Sleep Med . 2021;17(10):2057-2065.",2021,Mean percent APAP usage was higher in group A compared to group B (78.4% vs 67.8%; p=0.04).,"['obstructive sleep apnea (OSA', 'patients with obstructive sleep apnea', '156 adult patients newly diagnosed with OSA']","['30-minute personalized interface/mask fitting session supervised by a certified sleep technician during which APAP therapy', 'APAP machine', 'APAP therapy', 'Home Automatic Positive Airway Pressure (APAP', 'usual care']","['APAP usage (number of days APAP', 'percent APAP usage (number of days APAP', 'Mean percent APAP usage', 'APAP interface associated air leak', 'APAP adherence']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4761101', 'cui_str': 'Automatic positive airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C4761101', 'cui_str': 'Automatic positive airway pressure'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",156.0,0.0261143,Mean percent APAP usage was higher in group A compared to group B (78.4% vs 67.8%; p=0.04).,"[{'ForeName': 'Ziauddin', 'Initials': 'Z', 'LastName': 'Syed', 'Affiliation': 'Department of Internal Medicine, Ascension Genesys Hospital, Grand Blanc, Michigan.'}, {'ForeName': 'Isha', 'Initials': 'I', 'LastName': 'Mehta', 'Affiliation': 'Windsor University, School of Medicine, Cayon, Saint Kitts and Nevis, West Indies.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Hella', 'Affiliation': 'Department of Research, Ascension Genesys Hospital, Grand Blanc, Michigan.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Barber', 'Affiliation': 'Department of Research, Ascension Genesys Hospital, Grand Blanc, Michigan.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Khorfan', 'Affiliation': 'Department of Pulmonology and Critical Care, Ascension Genesys Hospital, Grand Blanc, Michigan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9368']
1211,33991350,"Population Pharmacokinetic Analysis of Bedaquiline-Clarithromycin for Dose Selection Against Pulmonary Nontuberculous Mycobacteria Based on a Phase 1, Randomized, Pharmacokinetic Study.","Based on the in vitro profile of bedaquiline against mycobacterial species, it is being investigated for clinical efficacy against pulmonary nontuberculous mycobacteria (PNTM). Being a cytochrome P450 3A substrate, pharmacokinetic interactions of bedaquiline are anticipated with clarithromycin (a cytochrome P450 3A inhibitor), which is routinely used in pulmonary nontuberculous mycobacteria treatment. This phase 1, randomized, crossover study assessed the impact of steady-state clarithromycin (500 mg every 12 hours for 14 days) on the pharmacokinetics of bedaquiline and its metabolite (M2) after single-dose bedaquiline (100 mg; n  =  16). Using these data, population pharmacokinetic modeling and simulation analyses were performed to determine the effect of clarithromycin on steady-state bedaquiline exposure. Although no effect was observed on maximum plasma concentration of bedaquiline and time to achieve maximum plasma concentration, its mean plasma exposure increased by 14% after 10 days of clarithromycin coadministration, with slower formation of M2. Simulations showed that bedaquiline plasma trough concentration at steady state was higher (up to 41% until week 48) with clarithromycin coadministration as compared to its monotherapy (400 mg once daily for 2 weeks, followed by 200 mg 3 times a week for 46 weeks; reference regimen). The overall exposure of a simulated bedaquiline regimen (400 mg once dialy for 2 weeks, followed by 200 mg twice a week for 46 weeks) with clarithromycin was comparable (<15% difference) to the monotherapy. Overall, combination of bedaquiline (400 mg once daily for 2 weeks, followed by 200 mg twice a week for 46 weeks) with clarithromycin seems a suitable regimen to be explored for efficacy and safety against pulmonary nontuberculous mycobacteria.",2021,"Although no effect was observed on maximum plasma concentration (C max  ) of bedaquiline and time to achieve C max  (t max  ), its mean plasma exposure increased by 14% after 10 days of clarithromycin coadministration, with slower formation of M2.",[],"['Bedaquiline-Clarithromycin', 'steady-state clarithromycin', 'bedaquiline', 'clarithromycin']","['bedaquiline plasma trough concentration', 'efficacy and safety against PNTM', 'pharmacokinetics of bedaquiline and its metabolite (M2', 'maximum plasma concentration (C max  ) of bedaquiline and time to achieve C max  (t max  ), its mean plasma exposure']",[],"[{'cui': 'C1664205', 'cui_str': 'bedaquiline'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C1664205', 'cui_str': 'bedaquiline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1265234', 'cui_str': 'Mycobacterium, non-TB'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0323221,"Although no effect was observed on maximum plasma concentration (C max  ) of bedaquiline and time to achieve C max  (t max  ), its mean plasma exposure increased by 14% after 10 days of clarithromycin coadministration, with slower formation of M2.","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kurosawa', 'Affiliation': 'Department of Clinical Pharmacology, Janssen Pharmaceutical KK, Tokyo, Japan.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Rossenu', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Jeike', 'Initials': 'J', 'LastName': 'Biewenga', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Sivi', 'Initials': 'S', 'LastName': 'Ouwerkerk-Mahadevan', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Willems', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Ernault', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Chrispin', 'Initials': 'C', 'LastName': 'Kambili', 'Affiliation': 'Johnson and Johnson Services, Inc, New Brunswick, New Jersey, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1887']
1212,34389780,Effect of adding hydrochlorothiazide to usual treatment of patients with acute decompensated heart failure: a randomized clinical trial.,"Acute decompensated heart failure (ADHF) is the leading cause of hospitalization in patients aged 65 years or older, and most of them present with congestion. The use of hydrochlorothiazide (HCTZ) may increase the response to loop diuretics. To evaluate the effect of adding HCTZ to furosemide on congestion and symptoms in patients with ADHF. This randomized clinical trial compared HCTZ 50 mg versus placebo for 3 days in patients with ADHF and signs of congestion. The primary outcome of the study was daily weight reduction. Secondary outcomes were change in creatinine, need for vasoactive drugs, change in natriuretic peptides, congestion score, dyspnea, thirst, and length of stay. Fifty-one patients were randomized-26 to the HCTZ group and 25 to the placebo group. There was an increment of 0.73 kg/day towards additional weight reduction in the HCTZ group (HCTZ: - 1.78 ± 1.08 kg/day vs placebo: - 1.05 ± 1.51 kg/day; p = 0.062). In post hoc analysis, the HCTZ group demonstrated significant weight reduction for every 40 mg of intravenous furosemide (HCTZ: - 0.74 ± 0.47 kg/40 mg vs placebo: - 0.33 ± 0.80 kg/40 mg; p = 0.032). There was a trend to increase in creatinine in the HCTZ group (HCTZ: 0.50 ± 0.37 vs placebo: 0.27 ± 0.40; p = 0.05) but no significant difference in onset of acute renal failure (HCTZ: 58% vs placebo: 41%; p = 0.38). No differences were found in the remaining outcomes. Adding hydrochlorothiazide to usual treatment of patients with acute decompensated heart failure did not cause significant difference in daily body weight reduction compared to placebo. In analysis adjusted to the dose of intravenous furosemide, adding HCTZ 50 mg to furosemide resulted in a significant synergistic effect on weight loss.Trial registration: The Brazilian Clinical Trials Registry (ReBEC), a publically accessible primary register that participates in the World Health Organization International Clinical Trial Registry Platform; number RBR-5qkn8h. Registered in 23/07/2019 (retrospectively), http://www.ensaiosclinicos.gov.br/rg/RBR-5qkn8h/ .",2021,Adding hydrochlorothiazide to usual treatment of patients with acute decompensated heart failure did not cause significant difference in daily body weight reduction compared to placebo.,"['Acute decompensated heart failure (ADHF', 'patients aged 65\xa0years or older', 'patients with ADHF', 'patients with acute decompensated heart failure', 'patients with ADHF and signs of congestion']","['hydrochlorothiazide (HCTZ', 'HCTZ', 'hydrochlorothiazide', 'furosemide (HCTZ', 'furosemide', 'placebo']","['additional weight reduction', 'daily weight reduction', 'creatinine', 'weight loss', 'acute renal failure', 'change in creatinine, need for vasoactive drugs, change in natriuretic peptides, congestion score, dyspnea, thirst, and length of stay', 'daily body weight reduction', 'congestion and symptoms', 'weight reduction']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0700148', 'cui_str': 'Congestion'}]","[{'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0700148', 'cui_str': 'Congestion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",51.0,0.535272,Adding hydrochlorothiazide to usual treatment of patients with acute decompensated heart failure did not cause significant difference in daily body weight reduction compared to placebo.,"[{'ForeName': 'Diogo Silva', 'Initials': 'DS', 'LastName': 'Piardi', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Maurício', 'Initials': 'M', 'LastName': 'Butzke', 'Affiliation': 'Serviço de Cardiologia, Hospital de Clínicas de Porto Alegre (HCPA), Rua Ramiro Barcelos, 2350, Porto Alegre, 90035-003, Brazil.'}, {'ForeName': 'Ana Carolina Martins', 'Initials': 'ACM', 'LastName': 'Mazzuca', 'Affiliation': 'Serviço de Cardiologia, Hospital de Clínicas de Porto Alegre (HCPA), Rua Ramiro Barcelos, 2350, Porto Alegre, 90035-003, Brazil.'}, {'ForeName': 'Bruna Sessim', 'Initials': 'BS', 'LastName': 'Gomes', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Sofia Giusti', 'Initials': 'SG', 'LastName': 'Alves', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Bruno Jaskulski', 'Initials': 'BJ', 'LastName': 'Kotzian', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Eduarda Chiesa', 'Initials': 'EC', 'LastName': 'Ghisleni', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Giaretta', 'Affiliation': 'Serviço de Cardiologia, Hospital de Clínicas de Porto Alegre (HCPA), Rua Ramiro Barcelos, 2350, Porto Alegre, 90035-003, Brazil.'}, {'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Bellaver', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Gabrielle Aguiar', 'Initials': 'GA', 'LastName': 'Varaschin', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Arthur Pereira', 'Initials': 'AP', 'LastName': 'Garbin', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Beck-da-Silva', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. lbneto@hcpa.edu.br.'}]",Scientific reports,['10.1038/s41598-021-96002-6']
1213,33992561,Utility of autologous fibrin glue in the donor site of free abdominal flap for breast reconstruction: A randomized controlled study.,"BACKGROUND


Seroma formation at the donor site is a common complication of breast reconstruction using free abdominal flap. In this study, we assessed the benefits of use of autologous fibrin glue (AFG) at the donor site.
METHODS


This randomized controlled study compared AFG group (n = 61) with commercial fibrin glue (CFG) group (n = 79). Owing to the high volume of AFG (10 mL), AFG group received fibrin glue at both the anastomosis and the donor sites, whereas CFG group received fibrin glue only at the anastomosis site. Operative protocols and the criteria for postoperative drain removal were identical in both groups. Patient characteristics and abdominal discharge were compared between the two groups.
RESULTS


Since anemia was a contraindication for use of AFG, preoperative Hb in CFG group was significantly lower than that in AFG group; other factors were comparable in the two groups. The mean total abdominal drain volumes on first postoperative day (POD1) and POD2 was (AFG vs. CFG) 130.9 vs. 169.4 mL (P < 0.001) and 131.0 vs. 162.8 mL (P = 0.03), respectively. On POD3, there was no significant difference in this respect (116.2 vs. 128.4 mL, P = 0.19). The mean time for removal of all abdominal drains was significantly lower in AFG group (7.4 vs. 8.4 days; P = 0.01).
CONCLUSIONS


AFG reduced the discharge at the donor site of free abdominal flap, especially in the early postoperative period. AFG helped to reduce the abdominal drainage period.",2021,"On POD3, there was no significant difference in this respect (116.2 vs. 128.4 mL, P = 0.19).","['breast reconstruction', 'group (n\u202f=\u202f61) with']","['autologous fibrin glue', 'commercial fibrin glue (CFG', 'fibrin glue', 'AFG', 'autologous fibrin glue (AFG']","['postoperative drain removal', 'Patient characteristics and abdominal discharge', 'mean total abdominal drain volumes on first postoperative day (POD1) and POD2', 'mean time for removal of all abdominal drains']","[{'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441140', 'cui_str': 'Abdominal drain'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",,0.166591,"On POD3, there was no significant difference in this respect (116.2 vs. 128.4 mL, P = 0.19).","[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Tokumoto', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Chiba Cancer Center Hospital, Chiba, Japan. Electronic address: tokumoto0414@yahoo.co.jp.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Akita', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Chiba University, Faculty of Medicine, Chiba, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Kubota', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Chiba University, Faculty of Medicine, Chiba, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Mitsukawa', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Chiba University, Faculty of Medicine, Chiba, Japan.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2021.03.073']
1214,33969866,Peer-delivered Cognitive Behavioral Therapy-based Intervention Reduced Depression and Stress in Community Dwelling Adults With Diabetes and Chronic Pain: A Cluster Randomized Trial.,"BACKGROUND


Finding effective, accessible treatment options such as professional-delivered cognitive behavioral therapy (CBT) for medically complex individuals is challenging in rural communities.
PURPOSE


We examined whether a CBT-based program intended to increase physical activity despite chronic pain in patients with diabetes delivered by community members trained as peer coaches also improved depressive symptoms and perceived stress.
METHODS


Participants in a cluster-randomized controlled trial received a 3-month telephonic lifestyle modification program with integrated CBT elements. Peer coaches assisted participants in developing skills related to adaptive coping, diabetes self-management goal-setting, stress reduction, and cognitive restructuring. Attention controls received general health advice with an equal number of contacts but no CBT elements. Depressive symptoms and stress were assessed using the Centers for Epidemiologic Studies Depression and Perceived Stress scales. Assessments occurred at baseline, 3 months, and 1 year.
RESULTS


Of 177 participants with follow-up data, 96% were African Americans, 79% women, and 74% reported annual income <$20,000. There was a significant reduction in perceived stress in intervention compared to control participants at 3-months (β = -2.79, p = .002 [95% CI -4.52, -1.07]) and 1 year (β = -2.59, p < .0001 [95% CI -3.30, -1.87]). Similarly, intervention participants reported significant decreases in depressive symptoms at 3-months (β = -2.48, p < .0001 [95% CI -2.48, -2.02]) and at 1 year (β = -1.62, p < .0001 [95% CI -2.37, -0.86]).
CONCLUSIONS


This peer-delivered CBT-based program improved depressive symptoms and stress in individuals with diabetes and chronic pain. Training community members may be a feasible strategy for offering CBT-based interventions in rural and under-resourced communities.
CLINICAL TRIAL REGISTRATION


NCT02538055.",2021,"There was a significant reduction in perceived stress in intervention compared to control participants at 3-months (β = -2.79, p = .002","['individuals with diabetes and chronic pain', 'Community Dwelling Adults With Diabetes and Chronic Pain', 'Participants in a cluster-randomized controlled trial', ' 96% were African Americans, 79% women, and 74% reported annual income <$20,000', 'patients with diabetes delivered by community members trained as peer coaches', '177 participants with follow-up data']","['cognitive behavioral therapy (CBT', 'Peer-delivered Cognitive Behavioral Therapy-based Intervention', 'telephonic lifestyle modification program with integrated CBT elements', 'CBT-based program', 'general health advice']","['adaptive coping, diabetes self-management goal-setting, stress reduction, and cognitive restructuring', 'depressive symptoms and stress', 'physical activity despite chronic pain', 'perceived stress', 'Depression and Stress', 'depressive symptoms', 'Depressive symptoms and stress', 'depressive symptoms and perceived stress']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",177.0,0.177327,"There was a significant reduction in perceived stress in intervention compared to control participants at 3-months (β = -2.79, p = .002","[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Andreae', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Lynn J', 'Initials': 'LJ', 'LastName': 'Andreae', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Richman', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Cherrington', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Monika M', 'Initials': 'MM', 'LastName': 'Safford', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab034']
1215,33970500,Integrating numerical cognition research and mathematics education to strengthen the teaching and learning of early number.,"BACKGROUND


Research into numerical cognition has contributed to a large body of knowledge on how children learn and perform mathematics. This knowledge has the potential to inform mathematics education. Unfortunately, numerical cognition research and mathematics education remain disconnected from one another, lacking the proper infrastructure to allow for productive and meaningful exchange between disciplines. The present study was designed to address this gap.
AIM


This study reports on the design, implementation, and effects of a 16-week (25-hour) mathematics Professional Development (PD) model for Kindergarten to Grade 3 educators and their students. A central goal of the PD was to better integrate numerical cognition research and mathematics education.
SAMPLE


A total of 45 K-3 educators and 180 of their students participated.
METHODS


To test the reproducibility and replicability of the model, the study was carried out across two different sites, over a two-year period, and involved a combination of two different study designs: a quasi-experimental pre-post-research design and a within-group crossover intervention design.
RESULT


The results of the first implementation (Year 1), indicated that compared to a control group, both teachers and students benefited from the intervention. Teachers demonstrated gains on both a self-report measure and a test of numerical cognition knowledge, while students demonstrated gains in number line estimation, arithmetic, and numeration. In Year 2, teachers in the intervention group demonstrated greater improvements than the control group on the self-report measure, but not the test of numerical cognition knowledge. At the student level, there was some evidence of gains in numeration.
CONCLUSION


The current PD model is a promising approach to better integrate research and practice. However, more research is needed to determine in which school contexts the model is most effective.",2021,"In Year 2, teachers in the intervention group demonstrated greater improvements than the control group on the self-report measure, but not the test, of numerical cognition knowledge.","['Kindergarten to Grade 3 educators and their students', 'A total of 45 K-3 educators and 180 of their students participated']",['16-week (25-hour) mathematics Professional Development (PD) model'],"['numerical cognition knowledge', 'self-report measure and test of numerical cognition knowledge', 'number line estimation, arithmetic, and numeration']","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",,0.0359291,"In Year 2, teachers in the intervention group demonstrated greater improvements than the control group on the self-report measure, but not the test, of numerical cognition knowledge.","[{'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Hawes', 'Affiliation': 'Department of Psychology, Brain and Mind Institute, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Merkley', 'Affiliation': 'Institute of Cognitive Science, Carleton University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Stager', 'Affiliation': 'Thames Valley District School Board, London, Ontario, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ansari', 'Affiliation': 'Department of Psychology, Brain and Mind Institute, University of Western Ontario, London, Ontario, Canada.'}]",The British journal of educational psychology,['10.1111/bjep.12421']
1216,33982872,Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial.,"OBJECTIVE


To assess whether folic acid supplementation ameliorates hot flushes.
DESIGN


Double-blind, placebo-controlled randomised trial.
SETTING


Nine hospitals in England.
POPULATION


Postmenopausal women experiencing ≥50 hot flushes weekly.
METHODS


Women (n = 164) were randomly assigned in a 1:1 ratio to receive folic acid 5 mg tablet or placebo daily for 12 weeks. Participants recorded frequency and severity of hot flushes in a Sloan Diary daily and completed Greene Climacteric and Utian Quality of Life (UQoL) Scales at 4-week intervals.
MAIN OUTCOME MEASURES


The change in daily Hot Flush Score at week 12 from randomisation based on Sloan Diary Composite Score B calculation.
RESULTS


Data of 143 (87%) women were available for the primary outcome. The mean change (SD) in Hot Flush Score at week 12 was -6.98 (10.30) and -4.57 (9.46) for folic acid and placebo group, respectively. The difference between groups in the mean change was -2.41 (95% CI -5.68 to 0.87) (P = 0.149) and in the adjusted mean change -2.61 (95% CI -5.72 to 0.49) (P = 0.098). Analysis of secondary outcomes indicated an increased benefit in the folic acid group regarding changes in total and emotional UQoL scores at week 8 when compared with placebo. The difference in the mean change from baseline was 5.22 (95% CI 1.16-9.28) and 1.88 (95% CI 0.23-3.52) for total and emotional score, respectively.
CONCLUSIONS


The study was not able to demonstrate that folic acid had a statistically significant greater benefit in reducing Hot Flush Score over 12 weeks in postmenopausal women when compared with placebo.
TWEETABLE ABSTRACT


Folic acid may ameliorate hot flushes in postmenopausal women but confirmation is required from a larger study.",2021,Analysis of secondary outcomes indicated an increased benefit in the folic acid group regarding changes in total and emotional UQoL scores at week-8 when compared with placebo.,"['Postmenopausal women experiencing ≥50 hot flushes weekly', 'Postmenopausal Women with Hot Flushes', 'Women (n=164', 'Nine hospitals in England', 'postmenopausal women']","['Folic Acid Supplementation', 'folic acid 5mg tablet or placebo', 'folic acid supplementation', 'folic acid and placebo', 'Placebo', 'folic acid', 'placebo']","['daily Hot Flush Score', 'total and emotional UQoL scores', 'frequency and severity of hot flushes in Sloan Diary daily and completed Greene Climacteric and Utian Quality of Life (UQoL) Scales', 'mean change (SD) in Hot Flush Score', 'Hot Flush Score']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C1128066', 'cui_str': 'Folic Acid 5 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",164.0,0.961249,Analysis of secondary outcomes indicated an increased benefit in the folic acid group regarding changes in total and emotional UQoL scores at week-8 when compared with placebo.,"[{'ForeName': 'Aaa', 'Initials': 'A', 'LastName': 'Ewies', 'Affiliation': 'Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Al-Azzawi', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pitkin', 'Affiliation': 'London Northwest University Healthcare NHS Trust, Harrow, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Persic', 'Affiliation': 'University Hospital of Derby and Burton NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sahu', 'Affiliation': 'Princess Royal Hospital, Shrewsbury and Telford NHS Trust, Shrewsbury, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Elgobashy', 'Affiliation': 'The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Barraclough', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Woodman', 'Affiliation': 'University Hospital Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Babrah', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bowden', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stocken', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Billingham', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sundar', 'Affiliation': 'Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rea', 'Affiliation': 'Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16739']
1217,33982093,"Impact of closed loop stimulation on prognostic cardiopulmonary variables in patients with chronic heart failure and severe chronotropic incompetence: a pilot, randomized, crossover study.","AIMS


Clinical effects of rate-adaptive pacing in heart failure patients with chronotropic incompetence (CI) undergoing cardiac resynchronization therapy (CRT) remain unclear. Closed loop stimulation (CLS) is a new rate-adaptive sensor in CRT devices. We evaluated the effectiveness of CLS in CRT patients with severe CI, focusing primarily on key prognostic variables assessed by cardiopulmonary exercise (CPX) testing.
METHODS AND RESULTS


In the randomized, crossover, multicentre BIO|CREATE study, 20 CRT patients with severe CI and NYHA Class II/III (60%/40%) were randomized 1:1 to the sequence DDD-40 mode to DDD-CLS mode, or the sequence DDD-CLS mode to DDD-40 mode (1 month in each mode). Patients underwent symptom-limited treadmill-based CPX test in each mode. An improvement (decrease) of the ventilatory efficiency (VE) slope of ≥5% during CLS was regarded as positive response to CLS. Seventeen patients with full data sets had a mean intra-individual VE slope change of -1.8 ± 3.0 (-4.1%) with CLS (P = 0.23). Eight patients (47%) were CLS responders, with a -6.1 ± 2.7 (-16.4%) slope change (P = 0.029). Compared to non-responders, CLS responders had a higher left ventricular (LV) ejection fraction (46 ± 3 vs. 36 ± 9%; P = 0.0070), smaller end-diastolic LV volume (121 ± 34 vs. 181 ± 41 mL; P = 0.0085), smaller end-systolic LV volume (65 ± 23 vs. 114 ± 39 mL; P = 0.0076), and were predominantly in NYHA Class II (P = 0.0498).
CONCLUSION


The data of the present pilot study are compatible with the notion that CLS activation may improve VE slope in CRT patients with severe CI and less advanced heart failure. Further research is needed to determine the long-term clinical outcomes of CLS.",2021,An improvement (decrease) of the ventilatory efficiency (VE) slope of ≥5% during CLS was regarded as positive response to CLS.,"['CRT patients with severe CI', '20 CRT patients with severe CI and NYHA Class II/III (60%/40', 'CRT patients with severe CI and less advanced heart failure', 'heart failure patients with chronotropic incompetence (CI) undergoing', 'patients with chronic heart failure and severe chronotropic incompetence']","['cardiac resynchronization therapy (CRT', 'closed loop stimulation', 'Closed loop stimulation (CLS', 'CLS', 'rate-adaptive pacing']","['mean intra-individual VE slope change', 'ventilatory efficiency (VE) slope', 'VE slope', 'prognostic cardiopulmonary variables', 'higher left ventricular (LV) ejection fraction', 'smaller end-systolic LV volume', 'smaller end-diastolic LV volume']","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1997984', 'cui_str': 'Chronotropic incompetence'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}]",17.0,0.0359953,An improvement (decrease) of the ventilatory efficiency (VE) slope of ≥5% during CLS was regarded as positive response to CLS.,"[{'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Proff', 'Affiliation': 'Medizinische Klinik für Kardiologie, Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis Medical University, Városmajorutca 68, 1122 Budapest, Hungary.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Papp', 'Affiliation': 'Heart and Vascular Center, Semmelweis Medical University, Városmajorutca 68, 1122 Budapest, Hungary.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Lenz', 'Affiliation': 'Klinik für Innere Medizin/Kardiologie, Unfallkrankenhaus Berlin, Warener Str. 7, 12683 Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordbeck', 'Affiliation': 'Medizinische Klinik I, Universitaetsklinikum Wuerzburg, Oberdürrbacher Str. 6, 97080 Wuerzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Butter', 'Affiliation': 'Kardiologie, Herzzentrum Brandenburg in Bernau & Medizinische Hochschule Brandenburt, Ladeburger Str. 17, 16321 Bernau bei Berlin, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Meyerhoefer', 'Affiliation': 'Innere Medizin - Kardiologie und Chest Pain Unit, Maria Heimsuchung-Caritas-Klinik Pankow, Breite Str. 46/47, 13187 Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doering', 'Affiliation': 'Abteilung für Rhythmologie, Herzzentrum Leipzig, Struempellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'MacCarter', 'Affiliation': '1324 Castle Point Circle, Castle Pines, CO, USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Ingel', 'Affiliation': 'Center for Clinical Research, BIOTRONIK SE & Co. KG, Woermannkehre 1, 12359 Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Thouet', 'Affiliation': 'Charite Universitaetsmedizin Berlin, Abteilung Sportmedizin, Philippstraße 13, Haus 11, 10115 Berlin, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Medizinische Klinik für Kardiologie, Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.'}, {'ForeName': 'Mattias J', 'Initials': 'MJ', 'LastName': 'Roser', 'Affiliation': 'Medizinische Klinik für Kardiologie, Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euab110']
1218,33984293,Outcomes of a Nursing Home-to-Community Care Transition Program.,"OBJECTIVES


Most transitional care initiatives to reduce rehospitalization have focused on the transition that occurs between a patient's hospital discharge and return home. However, many patients are discharged from a skilled nursing facility (SNF) to their homes. The goal was to evaluate the effectiveness of the Mayo Clinic Care Transitions (MCCT) program (hereafter called program) among patients discharged from SNFs to their homes.
DESIGN


Propensity-matched control-intervention trial.
INTERVENTION


Patients in the intervention group received care management following nursing stay (a home visit and nursing phone calls).
SETTING AND PARTICIPANTS


Patients enrolled after discharge from an SNF to home were matched to patients who did not receive intervention because of refusal, program capacity, or distance. Patients were aged ≥60 years, at high risk for hospitalization, and discharged from an SNF.
METHODS


Program enrollees were matched through propensity score to nonenrollees on the basis of age, sex, comorbid health burden, and mortality risk score. Conditional logistic regression analysis examined 30-day hospitalization and emergency department (ED) use; Cox proportional hazards analyses examined 180-day hospital stay and ED use.
RESULTS


Each group comprised 160 patients [mean (standard deviation) age, 85.4 (7.4) years]. Thirty-day hospitalization and ED rates were 4.4% and 10.0% in the program group and 3.8% and 10.0% in the group with usual care (P = .76 for hospitalization; P > .99 for ED). At 180 days, hospitalization and ED rates were 30.6% and 46.3% for program patients compared with 11.3% and 25.0% in the comparison group (P < .001).
CONCLUSIONS AND IMPLICATIONS


We found no evidence of reduced hospitalization or ED visits by program patients vs the comparison group. Such findings are crucial because they illustrate how aggressive stabilization care within the SNF may mitigate the program role. Furthermore, we found higher ED and hospitalization rates at 180 days in program patients than the comparison group.",2021,Thirty-day hospitalization and ED rates were 4.4% and 10.0% in the program group and 3.8% and 10.0% in the group with usual care (P = .76 for hospitalization; P > .99 for ED).,"['160 patients [mean (standard deviation) age, 85.4 (7.4) years', 'Patients were age ≥60\xa0years, at high risk for hospitalization, and discharged from an SNF', 'Patients enrolled after discharge from an SNF to home were matched to patients who did not receive intervention because of refusal, program capacity, or distance', 'Program enrollees were matched through propensity score to nonenrollees on the basis of age, sex, comorbid health burden, and mortality risk score', 'patients discharged from SNFs to their homes']","['Nursing Home-to-Community Care Transition Program', 'Mayo Clinic Care Transitions (MCCT) program (hereafter called program', 'care management following nursing stay (a home visit and nursing phone calls']","['30-day hospitalization and emergency department (ED) use; Cox proportional hazards analyses examined 180-day hospital stay and ED use', 'hospitalization and ED rates', 'higher ED and hospitalization rates', 'reduced hospitalization or ED visits', 'Thirty-day hospitalization and ED rates']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C3816446', 'cui_str': '30'}]",,0.0121497,Thirty-day hospitalization and ED rates were 4.4% and 10.0% in the program group and 3.8% and 10.0% in the group with usual care (P = .76 for hospitalization; P > .99 for ED).,"[{'ForeName': 'Paul Y', 'Initials': 'PY', 'LastName': 'Takahashi', 'Affiliation': 'Division of Community Internal Medicine, Mayo Clinic, Rochester, MN, USA; Division of Geriatric Medicine and Gerontology, Mayo Clinic, Rochester, MN, USA. Electronic address: takahashi.paul@mayo.edu.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Chandra', 'Affiliation': 'Division of Community Internal Medicine, Mayo Clinic, Rochester, MN, USA; Division of Geriatric Medicine and Gerontology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Rozalina G', 'Initials': 'RG', 'LastName': 'McCoy', 'Affiliation': 'Division of Community Internal Medicine, Mayo Clinic, Rochester, MN, USA; Division of Geriatric Medicine and Gerontology, Mayo Clinic, Rochester, MN, USA; Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Borkenhagen', 'Affiliation': 'Division of Community Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larson', 'Affiliation': 'Employee and Community Health, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Bjorg', 'Initials': 'B', 'LastName': 'Thorsteinsdottir', 'Affiliation': 'Division of Community Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Joel A', 'Initials': 'JA', 'LastName': 'Hickman', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kristi M', 'Initials': 'KM', 'LastName': 'Swanson', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Hanson', 'Affiliation': 'Division of Community Internal Medicine, Mayo Clinic, Rochester, MN, USA; Division of Geriatric Medicine and Gerontology, Mayo Clinic, Rochester, MN, USA; Division of Community Palliative Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Naessens', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.04.010']
1219,33990939,Well-being warriors: A randomized controlled trial examining the effects of martial arts training on secondary students' resilience.,"BACKGROUND


Mental health problems are a growing and significant issue in the Australian education system. Research has suggested that resilience can be learned and that schools can play an important role in developing resilient skills among youth; however, rigorous evaluation of interventions promoting resilience is limited.
AIMS


As martial arts training has been found to have psychological benefits such as increased confidence and self-esteem, this study investigated whether a 10-week martial arts training programme was an efficacious sports-based mental health intervention that promoted resilience in secondary school students.
SAMPLE


Two hundred and eighty-three secondary school students (age range 12-14 years) participated in the study.
METHODS


The study examined the effects of martial arts training on participants' resilience by delivering a 10-week martial arts-based intervention in secondary school settings. The intervention was evaluated using quantitative methodology and an experimental research design using a randomized controlled trial which measured participant responses at baseline, post-intervention, and follow-up.
RESULTS


The study found that the martial arts-based intervention had a significantly positive effect on developing students' resilience. This was especially apparent when the intervention and control group's mean resilience outcomes were compared. Resilience outcomes appeared to be stronger immediately following the intervention compared with 12-week follow-up.
CONCLUSIONS


Given the prevalence of mental illness among Australian youth, the current study provides robust evidence that students' resilience can be improved using martial arts-based interventions delivered in school settings.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Register ACTRN12618001405202. Registered 21 August 2018.",2021,"Resilience outcomes appeared to be stronger immediately following the intervention compared with 12-week follow-up.
","[""secondary students' resilience"", 'Australian youth', ""participants' resilience by delivering a 10-week martial arts-based intervention in secondary school settings"", 'Two hundred and eighty-three secondary school students (age range 12-14\xa0years) participated in the study']",['martial arts training'],"[""students' resilience""]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079801', 'cui_str': 'Martial arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0079801', 'cui_str': 'Martial arts'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]",,0.0490996,"Resilience outcomes appeared to be stronger immediately following the intervention compared with 12-week follow-up.
","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Moore', 'Affiliation': 'Charles Sturt University, Bathurst, NSW, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Woodcock', 'Affiliation': 'Griffith University, Qld, Australia.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Dudley', 'Affiliation': 'Macquarie University, NSW, Australia.'}]",The British journal of educational psychology,['10.1111/bjep.12422']
1220,33989683,Pneumatic Vitreolysis with Perfluoropropane for Vitreomacular Traction with and without Macular Hole: DRCR Retina Network Protocols AG and AH.,"PURPOSE


To evaluate pneumatic vitreolysis (PVL) in eyes with vitreomacular traction (VMT) with and without full-thickness macular hole (FTMH).
DESIGN


Two multicenter (28 sites) studies: a randomized clinical trial comparing PVL with observation (sham injection) for VMT without FTMH (Protocol AG) and a single-arm study assessing PVL for FTMH (Protocol AH).
PARTICIPANTS


Participants were adults with central VMT (vitreomacular adhesion was ≤3000 μm). In Protocol AG, visual acuity (VA) was 20/32 to 20/400. In Protocol AH, eyes had a FTMH (≤250 μm at the narrowest point) and VA of 20/25 to 20/400.
METHODS


Pneumatic vitreolysis using perfluoropropane (C 3 F 8 ) gas.
MAIN OUTCOME MEASURES


Central VMT release at 24 weeks (Protocol AG) and FTMH closure at 8 weeks (Protocol AH).
RESULTS


From October 2018 through February 2020, 46 participants were enrolled in Protocol AG, and 35 were enrolled in Protocol AH. Higher than expected rates of retinal detachment and tear resulted in early termination of both protocols. Combining studies, 7 of 59 eyes (12% [95% CI, 6%-23%]; 2 eyes in Protocol AG, 5 eyes in Protocol AH) that received PVL developed rhegmatogenous retinal detachment (n = 6) or retinal tear (n = 1). At 24 weeks in Protocol AG, 18 of 23 eyes in the PVL group (78%) versus 2 of 22 eyes in the sham group (9%) achieved central VMT release without rescue vitrectomy (adjusted risk difference, 66% [95% CI, 44%-88%]; P< 0.001). The mean change in VA from baseline at 24 weeks was 6.7 letters in the PVL group and 6.1 letters in the sham group (adjusted difference, -0.8 [95% CI, -6.1 to 4.5]; P = 0.77). In Protocol AH, 10 of 35 eyes (29% [95% CI, 16%-45%]) achieved FTMH closure without rescue vitrectomy at 8 weeks. The mean change in VA from baseline at 8 weeks was -1.5 letters (95% CI, -10.3 to 7.3 letters).
CONCLUSIONS


In most eyes with VMT, PVL induced hyaloid release. In eyes with FTMH, PVL resulted in hole closure in approximately one third of eyes. These studies were terminated early because of safety concerns related to retinal detachments and retinal tears.",2021,"The mean change in VA letter score from baseline at 24 weeks in AG was 6.7 in the PVL group and 6.1 in the sham group (adjusted difference = -0.8 [95% CI, -6.1 to 4.5], P=.77; negative values indicate greater improvement in sham group).","['Participants were adults with central VMT in which the vitreomacular adhesion was 3000 μm or less', 'eyes with vitreomacular traction (VMT) with and without full-thickness macular hole (FTMH', 'From October 2018 to February 2020, 46 participants were enrolled in AG and 35 eligible participants were enrolled in AH']","['pneumatic vitreolysis (PVL', 'PVL', 'FTMH', 'PVL with observation (sham injection) for VMT without FTMH (Protocol AG), and a single-arm study assessing PVL for closure of FTMH (Protocol AH', 'FTMH, PVL']","['mean change in VA letter score', 'hole closure', 'Central VMT release without rescue treatment at 24 weeks (AG', 'central VMT release without rescue vitrectomy', 'FTMH closure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C2748203', 'cui_str': 'Vitreomacular adhesion'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C2733564', 'cui_str': 'Full thickness hole of macula lutea'}]","[{'cui': 'C2733564', 'cui_str': 'Full thickness hole of macula lutea'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C2733564', 'cui_str': 'Full thickness hole of macula lutea'}]",46.0,0.473243,"The mean change in VA letter score from baseline at 24 weeks in AG was 6.7 in the PVL group and 6.1 in the sham group (adjusted difference = -0.8 [95% CI, -6.1 to 4.5], P=.77; negative values indicate greater improvement in sham group).","[{'ForeName': 'Clement K', 'Initials': 'CK', 'LastName': 'Chan', 'Affiliation': 'Southern California Desert Retina Consultants, Palm Desert, California.'}, {'ForeName': 'Calvin E', 'Initials': 'CE', 'LastName': 'Mein', 'Affiliation': 'Retinal Consultants of San Antonio, San Antonio, Texas.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida. Electronic address: drcrstat2@jaeb.org.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Claire T', 'Initials': 'CT', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mathew W', 'Initials': 'MW', 'LastName': 'MacCumber', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Maturi', 'Affiliation': 'Midwest Eye Institute, Indianapolis, Indiana.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Salehi-Had', 'Affiliation': 'Retina Associates of Southern California, Huntington Beach, California.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Rofagha', 'Affiliation': 'East Bay Retina Consultants, Oakland, California, and Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Department of Ophthalmology, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2021.05.005']
1221,33991702,Manipulative therapy of sacral torsion versus myofascial release in patients clinically diagnosed posterior pelvic pain: a consort compliant randomized controlled trial.,"BACKGROUND CONTEXT


Chronic low back pain represents a health care problem with substantial costs. It is generally accepted that approximately 10% to 25% of patients with persistent chronic low back pain may have pain arising from the sacroiliac joints.
PURPOSE


This study aimed to analyze the effects of manipulative therapy of sacral torsion versus myofascial release on disability, pain intensity, and mobility in patients with chronic low back pain and sacroiliac joints.
STUDY DESIGN/SETTING


A prospective, single-blinded randomized clinical trial.
PATIENT SAMPLE


Sixty-four patients (mean±SD age: 51±9; 60% female) with chronic low back pain and sacroiliac joints comprised the patient sample. No participant withdrew because of adverse effects.
OUTCOME MEASURES


Self-reported disability (primary), pain intensity, scale of kinesiophobia, quality of life, isometric endurance of trunk flexor muscles, and lumbar mobility in flexion were assessed at baseline, pos-treatment, and one month follow-up.
METHODS


Participants were randomly assigned to a sacral torsion manipulation group or myofascial release group, receiving a total of 12 sessions (once weekly).
RESULTS


ANCOVA did not showed a statistically significant difference between groups for disability (95% CI -2.40-1.90, p=.177). Effect sizes were large in both groups at both follow-up periods. Similar results were achieved for all secondary outcomes (p˂. 05). The linear model longitudinal analyses showed significant improvements in both groups over time for all outcomes with the exception of fear of movement (manipulative: Minimum within-groups change score 1.91, p˂.001; myofascial: 1.66, p˂.001).
CONCLUSION


Manipulative and myofascial release therapy in patients with clinically diagnosed sacroiliac joints syndrome resulted in a similar short-term benefits on patient reported disability. Both groups experienced similar decrease in the intensity of pain over time, although no clinically meaningful effects were demonstrated in either group.",2021,"Both groups experienced similar decrease in the intensity of pain over time, although no clinically meaningful effects were demonstrated in either group.","['patients with chronic low back pain and sacroiliac joints', 'SAMPLE\n\n\nSixty-four patients (mean ± SD age: 51 ± 9; 60% female) with chronic low back pain and sacroiliac joints', 'patients with clinically diagnosed sacroiliac joints syndrome', 'CLINICALLY DIAGNOSED POSTERIOR PELVIC PAIN', 'Participants']","['manipulative therapy of sacral torsion versus myofascial release', 'Manipulative and myofascial release therapy', 'sacral torsion manipulation group or myofascial release group, receiving a total of 12 sessions (once weekly']","['disability, pain intensity, and mobility', 'adverse effects', 'Self-reported disability (primary), pain intensity, scale of kinesiophobia, quality of life, isometric endurance of trunk flexor muscles, and lumbar mobility in flexion', 'disability', 'intensity of pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}]","[{'cui': 'C0949742', 'cui_str': 'Therapy, Manipulation'}, {'cui': 'C1561996', 'cui_str': 'Sacral torsion'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.126483,"Both groups experienced similar decrease in the intensity of pain over time, although no clinically meaningful effects were demonstrated in either group.","[{'ForeName': 'Adelaida María', 'Initials': 'AM', 'LastName': 'Castro-Sánchez', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almería, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Gil-Martínez', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almería, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fernández-Sánchez', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almería, Spain. Electronic address: manuelf@ual.es.'}, {'ForeName': 'Inmaculada Carmen', 'Initials': 'IC', 'LastName': 'Lara-Palomo', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almería, Spain.'}, {'ForeName': 'Iuliana', 'Initials': 'I', 'LastName': 'Nastasia', 'Affiliation': 'Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail (IRSST), Montréal, Canada.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'de Los Ángeles Querol-Zaldívar', 'Affiliation': 'Rehabilitation Clinic Management Unit, Puerto Real University Hospital (Cádiz), Cádiz, Spain.'}, {'ForeName': 'María Encarnación', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': 'Department of Physical Therapy, Instituto de Investigación Biosanitaria Granada (IBIS.Granada), University of Granada (UGR), Granada, Spain.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2021.05.002']
1222,33994084,A comparative study of variable angle volar plate and bridging external fixator with K-wire augmentation in comminuted distal radius fractures.,"PURPOSE


Comminuted intraarticular distal radial fractures are difficult to treat conservatively and require operative treatment. This study compared the functional outcomes between variable angle volar plating and external fixator with K-wire augmentation in open reduction and internal fixation.
METHODS


A total of 62 adult patients with comminuted intraarticular distal radius fracture were randomized into 2 groups: volar plate group and external fixator group. These patients aged between 18 and 60 years had unilateral fractures, and agreed to be included in the study. Patients with a history of fracture, bilateral fracture, associated other injuries, delayed injury for more than 2 weeks, open fracture, pre-existing arthrosis or disability, psychiatric illness and pathological fracture were excluded. Patients were followed up at 6 weeks, 3 months, 6 months and 1 year. The assessment of pain, functional activity, range of motion and grip strength was done at each stage of follow-up. The pain and functional activities were assessed by patient rated wrist evaluation (PRWE) score and disabilities of the arm, shoulder and hand (DASH) score.
RESULTS


Patients in volar plate group had superior PRWE score and DASH score at each stage of follow-up. At 1 year follow-up, the mean PRWE score were 7.48 for volar plate group and 7.35 for external fixator group; while the mean DASH score was 4.65 for volar plate group and 5.61 for external fixator group. They had better flexion and extension range of movement. They also had better pronation and supination range of motion at initial follow-up, however the difference get attenuated by 1 year. Volar plate group had significantly better grip strength than external fixator group. Complication rates were higher in external fixation group.
CONCLUSION


Fixation with variable angle volar plate results in early wrist mobilization, better range of movement, less pain and disability and early return of function.",2021,"They also had better pronation and supination range of motion at initial follow-up, however the difference get attenuated by 1 year.","['Patients with a history of fracture, bilateral fracture, associated other injuries, delayed injury for more than 2 weeks, open fracture, pre-existing arthrosis or disability, psychiatric illness and pathological fracture were excluded', '62 adult patients with comminuted intraarticular distal radius fracture', 'patients aged between 18 and 60 years had unilateral fractures, and agreed to be included in the study', 'comminuted distal radius fractures']","['volar plate group and external fixator group', 'variable angle volar plating and external fixator with K-wire augmentation', 'variable angle volar plate and bridging external fixator with K-wire augmentation', 'Fixation with variable angle volar plate']","['mean PRWE score', 'pain, functional activity, range of motion and grip strength', 'Complication rates', 'better flexion and extension range of movement', 'grip strength', 'superior PRWE score and DASH score', 'early wrist mobilization, better range of movement, less pain and disability and early return of function', 'pain and functional activities', 'mean DASH score', 'patient rated wrist evaluation (PRWE) score and disabilities of the arm, shoulder and hand (DASH) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272071', 'cui_str': 'H/O: fracture'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0016662', 'cui_str': 'Fracture, open'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0016663', 'cui_str': 'Pathological fracture'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0476171', 'cui_str': 'Fracture, comminuted'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079321', 'cui_str': 'External fixation device'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",62.0,0.0486644,"They also had better pronation and supination range of motion at initial follow-up, however the difference get attenuated by 1 year.","[{'ForeName': 'Ratish Kumar', 'Initials': 'RK', 'LastName': 'Mishra', 'Affiliation': 'Orthopedic Department, Sir Gangaram Hospital, New Delhi 11006, India.'}, {'ForeName': 'Bhagwati Prasad', 'Initials': 'BP', 'LastName': 'Sharma', 'Affiliation': 'Central Institute of Orthopedics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Orthopedic Department, All India Institute of Medical Sciences, Rae Bareli 229405, India. Electronic address: amitdr87@gmail.com.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Sherawat', 'Affiliation': 'Central Institute of Orthopaedics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029, India.'}]",Chinese journal of traumatology = Zhonghua chuang shang za zhi,['10.1016/j.cjtee.2021.04.005']
1223,34003690,Randomized Placebo-Controlled Trial of Ferric Carboxymaltose in Heart Failure With Iron Deficiency: Rationale and Design.,"BACKGROUND


Iron deficiency (ID) has a prevalence of ≈40% to 50% among patients in heart failure (HF) with reduced ejection fraction and is associated with worse prognosis. Several trials demonstrated that intravenous ferric carboxymaltose leads to early and sustained improvement in patient-reported outcomes and functional capacity in patients with HF with reduced ejection fraction with ID, yet morbidity and mortality data are limited.
METHODS


The objective of the HEART-FID trial (Ferric Carboxymaltose in Heart Failure With Iron Deficiency) is to assess efficacy and safety of ferric carboxymaltose compared with placebo as treatment for symptomatic HF with reduced ejection fraction with ID. HEART-FID is a multicenter, randomized, double-blind, placebo-controlled trial enrolling ≈3014 patients at ≈300 international centers. Eligible patients are aged ≥18 years in stable chronic HF with New York Heart Association functional class II to IV symptoms, ejection fraction ≤40%, ID (ferritin <100 ng/mL or ferritin 100-300 ng/mL with a transferrin saturation <20%), and documented HF hospitalization or elevated N-terminal pro-brain natriuretic peptide. Consented patients are assigned to ferric carboxymaltose or placebo at baseline, with repeated visits/assessments every 6 months for additional study drug based on hemoglobin and iron indices for the trial duration. The primary end point is a hierarchical composite of death and HF hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance.
CONCLUSIONS


The HEART-FID trial will inform clinical practice by clarifying the role of long-term treatment with intravenous ferric carboxymaltose, added to usual care, in ambulatory patients with symptomatic HF with reduced ejection fraction with ID. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03037931.",2021,"Several trials demonstrated that intravenous ferric carboxymaltose leads to early and sustained improvement in patient-reported outcomes and functional capacity in patients with HF with reduced ejection fraction with ID, yet morbidity and mortality data are limited.
","['Heart Failure', '≈3014 patients at ≈300 international centers', 'ambulatory patients with symptomatic HF with reduced ejection fraction with ID', 'Eligible patients are aged ≥18 years in stable chronic HF with New York Heart Association functional class II to IV symptoms, ejection fraction ≤40%, ID (ferritin <100 ng/mL or ferritin 100-300 ng/mL with a transferrin saturation <20%), and documented HF hospitalization or elevated N-terminal pro-brain natriuretic peptide']","['ferric carboxymaltose', 'intravenous ferric carboxymaltose', 'HEART-FID trial (Ferric Carboxymaltose', 'Placebo', 'Ferric Carboxymaltose', 'placebo', 'ferric carboxymaltose or placebo']","['hierarchical composite of death and HF hospitalization', '6-minute walk test distance']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]","[{'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.625167,"Several trials demonstrated that intravenous ferric carboxymaltose leads to early and sustained improvement in patient-reported outcomes and functional capacity in patients with HF with reduced ejection fraction with ID, yet morbidity and mortality data are limited.
","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (R.J.M., F.R., J.G., M.D.S., D.L., A.F.H.).'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Cardiology, The Permanente Medical Group, San Francisco, CA (A.P.A.).'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (J.A.E.).'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Division of Cardiology, Massachusetts General Hospital, Boston (G.D.L.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson (J.B.).'}, {'ForeName': 'Yee Weng', 'Initials': 'YW', 'LastName': 'Wong', 'Affiliation': 'Heart Lung Institute, The Prince Charles Hospital, and School of Clinical Medicine, The University of Queensland, Australia (Y.W.W.).'}, {'ForeName': 'Carmine G', 'Initials': 'CG', 'LastName': 'De Pasquale', 'Affiliation': 'Flinders Medical Centre, Adelaide, South Australia (C.G.D.P.).'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Troughton', 'Affiliation': 'Department of Medicine, Christchurch Heart Institute, University of Otago, Christchurch, New Zealand (R.W.T.).'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute and Université de Montréal, Quebec, Canada (E.O.).'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (R.J.M., F.R., J.G., M.D.S., D.L., A.F.H.).'}, {'ForeName': 'Jyostna', 'Initials': 'J', 'LastName': 'Garg', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (R.J.M., F.R., J.G., M.D.S., D.L., A.F.H.).'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Samsky', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (R.J.M., F.R., J.G., M.D.S., D.L., A.F.H.).'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Leloudis', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (R.J.M., F.R., J.G., M.D.S., D.L., A.F.H.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dugan', 'Affiliation': 'American Regent, Inc, Norristown, Pennsylvania (M.D., L.M.M.).'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Mundy', 'Affiliation': 'American Regent, Inc, Norristown, Pennsylvania (M.D., L.M.M.).'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (R.J.M., F.R., J.G., M.D.S., D.L., A.F.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.120.008100']
1224,33974018,Effect of Antimicrobial Therapy on Respiratory Hospitalization or Death in Adults With Idiopathic Pulmonary Fibrosis: The CleanUP-IPF Randomized Clinical Trial.,"Importance


Alteration in lung microbes is associated with disease progression in idiopathic pulmonary fibrosis.
Objective


To assess the effect of antimicrobial therapy on clinical outcomes.
Design, Setting, and Participants


Pragmatic, randomized, unblinded clinical trial conducted across 35 US sites. A total of 513 patients older than 40 years were randomized from August 2017 to June 2019 (final follow-up was January 2020).
Interventions


Patients were randomized in a 1:1 allocation ratio to receive antimicrobials (n = 254) or usual care alone (n = 259). Antimicrobials included co-trimoxazole (trimethoprim 160 mg/sulfamethoxazole 800 mg twice daily plus folic acid 5 mg daily, n = 128) or doxycycline (100 mg once daily if body weight <50 kg or 100 mg twice daily if ≥50 kg, n = 126). No placebo was administered in the usual care alone group.
Main Outcomes and Measures


The primary end point was time to first nonelective respiratory hospitalization or all-cause mortality.
Results


Among the 513 patients who were randomized (mean age, 71 years; 23.6% women), all (100%) were included in the analysis. The study was terminated for futility on December 18, 2019. After a mean follow-up time of 13.1 months (median, 12.7 months), a total of 108 primary end point events occurred: 52 events (20.4 events per 100 patient-years [95% CI, 14.8-25.9]) in the usual care plus antimicrobial therapy group and 56 events (18.4 events per 100 patient-years [95% CI, 13.2-23.6]) in the usual care group, with no significant difference between groups (adjusted HR, 1.04 [95% CI, 0.71-1.53; P = .83]. There was no statistically significant interaction between the effect of the prespecified antimicrobial agent (co-trimoxazole vs doxycycline) on the primary end point (adjusted HR, 1.15 [95% CI 0.68-1.95] in the co-trimoxazole group vs 0.82 [95% CI, 0.46-1.47] in the doxycycline group; P = .66). Serious adverse events occurring at 5% or greater among those treated with usual care plus antimicrobials vs usual care alone included respiratory events (16.5% vs 10.0%) and infections (2.8% vs 6.6%); adverse events of special interest included diarrhea (10.2% vs 3.1%) and rash (6.7% vs 0%).
Conclusions and Relevance


Among adults with idiopathic pulmonary fibrosis, the addition of co-trimoxazole or doxycycline to usual care, compared with usual care alone, did not significantly improve time to nonelective respiratory hospitalization or death. These findings do not support treatment with these antibiotics for the underlying disease.
Trial Registration


ClinicalTrials.gov Identifier: NCT02759120.",2021,"Serious adverse events occurring at 5% or greater among those treated with usual care plus antimicrobials vs usual care alone included respiratory events (16.5% vs 10.0%) and infections (2.8% vs 6.6%); adverse events of special interest included diarrhea (10.2% vs 3.1%) and rash (6.7% vs 0%).
","['adults with idiopathic pulmonary fibrosis', '513 patients who were randomized (mean age, 71 years; 23.6% women), all (100%) were included in the analysis', '513 patients older than 40 years were randomized from August 2017 to June 2019 (final follow-up was January 2020', 'Adults With Idiopathic Pulmonary Fibrosis']","['antimicrobial therapy', 'trimoxazole or doxycycline', 'Antimicrobial Therapy', 'doxycycline', 'antimicrobials (n\u2009=\u2009254) or usual care alone', 'trimoxazole vs doxycycline', 'placebo', 'trimoxazole (trimethoprim 160 mg/sulfamethoxazole 800 mg twice daily plus folic acid']","['adverse events of special interest included diarrhea', 'time to nonelective respiratory hospitalization or death', 'Respiratory Hospitalization or Death', 'respiratory events', 'time to first nonelective respiratory hospitalization or all-cause mortality', 'Serious adverse events', 'rash']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0990950', 'cui_str': 'Trimethoprim 160 MG'}, {'cui': 'C0990426', 'cui_str': 'Sulfamethoxazole 800 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",513.0,0.201267,"Serious adverse events occurring at 5% or greater among those treated with usual care plus antimicrobials vs usual care alone included respiratory events (16.5% vs 10.0%) and infections (2.8% vs 6.6%); adverse events of special interest included diarrhea (10.2% vs 3.1%) and rash (6.7% vs 0%).
","[{'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York Presbyterian Hospital/Weill Cornell Medicine, New York.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Yow', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Laurie D', 'Initials': 'LD', 'LastName': 'Snyder', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Durheim', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Sciurba', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Washington, Seattle.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Brooks', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Dong-Yun', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Dilling', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Minnesota, Minneapolis.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Belloli', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Anoop M', 'Initials': 'AM', 'LastName': 'Nambiar', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Texas Health San Antonio.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Scholand', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Utah, Salt Lake City.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Noth', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Virginia, Charlottesville.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2021.4956']
1225,33979200,A Pilot Randomized Trial of a Brief Intervention to Prevent Suicide After Inpatient Psychiatric Discharge.,"OBJECTIVE


Risk for suicide is high after psychiatric hospitalization. The World Health Organization's Brief Intervention and Contact (BIC) program has shown efficacy in preventing suicide. A version adapted for the U.S. Department of Veterans Affairs (VA) was studied to determine preliminary effects.
METHODS


Patients receiving psychiatric hospitalization because of acute risk for self-harm were randomly assigned to the VA BIC or standard care alone. Effect sizes (Hedges' g) for suicidal ideation (primary outcome), social connectedness (measured as thwarted belongingness and perceived burdensomeness), hopelessness, and engagement were calculated at 1 and 3 months.
RESULTS


Patients were randomly assigned to the VA BIC (N=10) or standard care (N=9). The VA BIC had a medium or large effect on most measures at 1 month (suicidal ideation, g=0.45). Effects diminished at 3 months, except for thwarted belongingness (g=0.81).
CONCLUSIONS


The VA BIC had meaningful effects on suicide-related outcomes. The largest effect was seen in the first month.",2021,"The VA BIC had a medium or large effect on most measures at 1 month (suicidal ideation, g=0.45).",['Patients receiving psychiatric hospitalization because of acute risk for self-harm'],"['VA BIC or standard care alone', 'VA BIC', 'Contact (BIC) program']","['Suicide', 'suicidal ideation (primary outcome), social connectedness (measured as thwarted belongingness and perceived burdensomeness), hopelessness, and engagement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}]","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0521777,"The VA BIC had a medium or large effect on most measures at 1 month (suicidal ideation, g=0.45).","[{'ForeName': 'Natalie B', 'Initials': 'NB', 'LastName': 'Riblet', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Medical Center, White River Junction, Vermont (Riblet, Stevens, Watts, Forehand, Cornelius, Powell, Lewicki, Shiner); Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire (Riblet, Stevens, Watts, Gui, Powell, Lewicki, Shiner); VA Office of Systems Redesign and Improvement, White River Junction, Vermont (Watts); National Centre for Suicide Research and Prevention of Mental Ill-Health, and World Health Organization Collaborating Centre for Research, Methods, Development and Training in Suicide Prevention, Karolinska Institutet, Stockholm (Wasserman).Send correspondence to Dr. Riblet (natalie.bv.riblet@dartmouth.edu).'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Stevens', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Medical Center, White River Junction, Vermont (Riblet, Stevens, Watts, Forehand, Cornelius, Powell, Lewicki, Shiner); Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire (Riblet, Stevens, Watts, Gui, Powell, Lewicki, Shiner); VA Office of Systems Redesign and Improvement, White River Junction, Vermont (Watts); National Centre for Suicide Research and Prevention of Mental Ill-Health, and World Health Organization Collaborating Centre for Research, Methods, Development and Training in Suicide Prevention, Karolinska Institutet, Stockholm (Wasserman).Send correspondence to Dr. Riblet (natalie.bv.riblet@dartmouth.edu).'}, {'ForeName': 'Bradley V', 'Initials': 'BV', 'LastName': 'Watts', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Medical Center, White River Junction, Vermont (Riblet, Stevens, Watts, Forehand, Cornelius, Powell, Lewicki, Shiner); Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire (Riblet, Stevens, Watts, Gui, Powell, Lewicki, Shiner); VA Office of Systems Redesign and Improvement, White River Junction, Vermont (Watts); National Centre for Suicide Research and Prevention of Mental Ill-Health, and World Health Organization Collaborating Centre for Research, Methods, Development and Training in Suicide Prevention, Karolinska Institutet, Stockholm (Wasserman).Send correspondence to Dr. Riblet (natalie.bv.riblet@dartmouth.edu).'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Gui', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Medical Center, White River Junction, Vermont (Riblet, Stevens, Watts, Forehand, Cornelius, Powell, Lewicki, Shiner); Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire (Riblet, Stevens, Watts, Gui, Powell, Lewicki, Shiner); VA Office of Systems Redesign and Improvement, White River Junction, Vermont (Watts); National Centre for Suicide Research and Prevention of Mental Ill-Health, and World Health Organization Collaborating Centre for Research, Methods, Development and Training in Suicide Prevention, Karolinska Institutet, Stockholm (Wasserman).Send correspondence to Dr. Riblet (natalie.bv.riblet@dartmouth.edu).'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Forehand', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Medical Center, White River Junction, Vermont (Riblet, Stevens, Watts, Forehand, Cornelius, Powell, Lewicki, Shiner); Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire (Riblet, Stevens, Watts, Gui, Powell, Lewicki, Shiner); VA Office of Systems Redesign and Improvement, White River Junction, Vermont (Watts); National Centre for Suicide Research and Prevention of Mental Ill-Health, and World Health Organization Collaborating Centre for Research, Methods, Development and Training in Suicide Prevention, Karolinska Institutet, Stockholm (Wasserman).Send correspondence to Dr. Riblet (natalie.bv.riblet@dartmouth.edu).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cornelius', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Medical Center, White River Junction, Vermont (Riblet, Stevens, Watts, Forehand, Cornelius, Powell, Lewicki, Shiner); Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire (Riblet, Stevens, Watts, Gui, Powell, Lewicki, Shiner); VA Office of Systems Redesign and Improvement, White River Junction, Vermont (Watts); National Centre for Suicide Research and Prevention of Mental Ill-Health, and World Health Organization Collaborating Centre for Research, Methods, Development and Training in Suicide Prevention, Karolinska Institutet, Stockholm (Wasserman).Send correspondence to Dr. Riblet (natalie.bv.riblet@dartmouth.edu).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Powell', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Medical Center, White River Junction, Vermont (Riblet, Stevens, Watts, Forehand, Cornelius, Powell, Lewicki, Shiner); Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire (Riblet, Stevens, Watts, Gui, Powell, Lewicki, Shiner); VA Office of Systems Redesign and Improvement, White River Junction, Vermont (Watts); National Centre for Suicide Research and Prevention of Mental Ill-Health, and World Health Organization Collaborating Centre for Research, Methods, Development and Training in Suicide Prevention, Karolinska Institutet, Stockholm (Wasserman).Send correspondence to Dr. Riblet (natalie.bv.riblet@dartmouth.edu).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lewicki', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Medical Center, White River Junction, Vermont (Riblet, Stevens, Watts, Forehand, Cornelius, Powell, Lewicki, Shiner); Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire (Riblet, Stevens, Watts, Gui, Powell, Lewicki, Shiner); VA Office of Systems Redesign and Improvement, White River Junction, Vermont (Watts); National Centre for Suicide Research and Prevention of Mental Ill-Health, and World Health Organization Collaborating Centre for Research, Methods, Development and Training in Suicide Prevention, Karolinska Institutet, Stockholm (Wasserman).Send correspondence to Dr. Riblet (natalie.bv.riblet@dartmouth.edu).'}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Wasserman', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Medical Center, White River Junction, Vermont (Riblet, Stevens, Watts, Forehand, Cornelius, Powell, Lewicki, Shiner); Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire (Riblet, Stevens, Watts, Gui, Powell, Lewicki, Shiner); VA Office of Systems Redesign and Improvement, White River Junction, Vermont (Watts); National Centre for Suicide Research and Prevention of Mental Ill-Health, and World Health Organization Collaborating Centre for Research, Methods, Development and Training in Suicide Prevention, Karolinska Institutet, Stockholm (Wasserman).Send correspondence to Dr. Riblet (natalie.bv.riblet@dartmouth.edu).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Shiner', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Medical Center, White River Junction, Vermont (Riblet, Stevens, Watts, Forehand, Cornelius, Powell, Lewicki, Shiner); Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire (Riblet, Stevens, Watts, Gui, Powell, Lewicki, Shiner); VA Office of Systems Redesign and Improvement, White River Junction, Vermont (Watts); National Centre for Suicide Research and Prevention of Mental Ill-Health, and World Health Organization Collaborating Centre for Research, Methods, Development and Training in Suicide Prevention, Karolinska Institutet, Stockholm (Wasserman).Send correspondence to Dr. Riblet (natalie.bv.riblet@dartmouth.edu).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000537']
1226,33986477,"Darbepoetin as a neuroprotective agent in mild neonatal encephalopathy: a randomized, placebo-controlled, feasibility trial.","OBJECTIVE


To assess the feasibility and safety of one dose of Darbepoetin alpha (Darbe) administered to neonates ≥34 weeks with mild neonatal encephalopathy (NE).
METHODS


Randomized, masked, placebo-controlled study including neonates ≥34 weeks gestation with mild NE. Neonates were randomized to receive one dose of Darbe (10 μg/kg IV) or placebo. Clinical and laboratory maternal and newborn data were collected. The Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) and a standardized neurological examination at 8-12 months of corrected age were assessed.
RESULTS


There were no differences in baseline characteristics of the 21 infants randomized (9 Darbe, 12 placebo). Adverse events were not reported at any time. Bayley-III scores were average in both Darbe and placebo groups.
CONCLUSION


This study demonstrates that a randomized, masked, placebo-controlled trial is safe and feasible. A large, randomized trial is warranted to assess the effect of Darbe in this population.",2021,Adverse events were not reported at any time.,"['neonates ≥34 weeks gestation with mild NE', 'mild neonatal encephalopathy', 'neonates ≥34 weeks with mild neonatal encephalopathy (NE']","['Darbepoetin', 'placebo', 'Darbepoetin alpha (Darbe']","['Bayley-III scores', 'Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) and a standardized neurological examination', 'Adverse events']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy'}]","[{'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",21.0,0.791694,Adverse events were not reported at any time.,"[{'ForeName': 'Tara L', 'Initials': 'TL', 'LastName': 'DuPont', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA. tara.dupont@hsc.utah.edu.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Baserga', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Lowe', 'Affiliation': 'University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Zamora', 'Affiliation': 'University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Beauman', 'Affiliation': 'University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Ohls', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-021-01081-y']
1227,33986339,Cues to gender and racial identity reduce creativity in diverse social networks.,"The characteristics of social partners have long been hypothesized as influential in guiding group interactions. Understanding how demographic cues impact networks of creative collaborators is critical for elevating creative performances therein. We conducted a randomized experiment to investigate how the knowledge of peers' gender and racial identities distorts people's connection patterns and the resulting creative outcomes in a dynamic social network. Consistent with prior work, we found that creative inspiration links are primarily formed with top idea-generators. However, when gender and racial identities are known, not only is there (1) an increase of [Formula: see text] in the odds of same-gender connections to persist (but not for same-race connections), but (2) the semantic similarity of idea-sets stimulated by these connections also increase significantly compared to demography-agnostic networks, negatively impacting the outcomes of divergent creativity. We found that ideas tend to be significantly more homogeneous within demographic groups than between, taking away diversity-bonuses from similarity-based links and partly explaining the results. These insights can inform intelligent interventions to enhance network-wide creative performances.",2021,We conducted a randomized experiment to investigate how the knowledge of peers' gender and racial identities distorts people's connection patterns and the resulting creative outcomes in a dynamic social network.,[],[],[],[],[],[],,0.0463265,We conducted a randomized experiment to investigate how the knowledge of peers' gender and racial identities distorts people's connection patterns and the resulting creative outcomes in a dynamic social network.,"[{'ForeName': 'Raiyan Abdul', 'Initials': 'RA', 'LastName': 'Baten', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Aslin', 'Affiliation': 'Haskins Laboratories and Department of Psychology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Gourab', 'Initials': 'G', 'LastName': 'Ghoshal', 'Affiliation': 'Department of Physics and Astronomy, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Hoque', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, NY, USA. mehoque@cs.rochester.edu.'}]",Scientific reports,['10.1038/s41598-021-89498-5']
1228,33990376,Reductions in Management Distress Following a Randomized Distress Intervention Are Associated With Improved Diabetes Behavioral and Glycemic Outcomes Over Time.,"OBJECTIVE


To explore associations between reductions in diabetes distress (DD) and improvements in glycemic outcomes among adults with type 1 diabetes (T1D) in the context of a DD randomized clinical trial.
RESEARCH DESIGN AND METHODS


Adults with T1D ( N  = 301) participated in a two-arm trial aimed at reducing DD (DD-focused OnTrack group vs. education-oriented KnowIt group). Mean age was 45.1 years; mean baseline HbA 1c  was 8.8% (73 mmol/mol). Individuals were assessed at baseline and 9 months later on DD, self-care, HbA 1c , and frequency of hypoglycemia. Structural equation models evaluated hypothesized pathways among changes in DD, self-care, and glycemic outcomes in the total sample and by intervention group.
RESULTS


Reductions in DD were significantly and independently associated with better self-care, including fewer missed insulin boluses, more frequent insulin adjustment, improved problem-solving skills, more blood glucose monitoring, and greater adoption of continuous glucose monitoring (all  P  < 0.05). In turn, better self-care was linked with better glycemic outcomes, including fewer episodes of hypoglycemia and improved HbA 1c  over time. Fit indices indicated good fit of the model to the data (confirmatory fit index = 0.94, root mean square error of approximation = 0.05), with stronger and more meaningful associations for OnTrack than for KnowIt.
CONCLUSIONS


In the context of an intervention to reduce DD for adults with T1D, results indicate that reductions in DD do not affect glycemic outcomes directly but through improvements in self-care behavior. Findings support the importance of integrating disease management with DD interventions to maximize improvements in glycemic outcomes.",2021,"Fit indices indicated good fit of the model to the data (confirmatory fit index = 0.94, root mean square error of approximation = 0.05), with stronger and more meaningful associations for OnTrack than for KnowIt.
","['adults with T1D', 'Mean age was 45.1 years; mean baseline HbA 1c  was 8.8% (73 mmol/mol', 'adults with type 1 diabetes (T1D', 'Adults with T1D ( N  = 301']","['DD (DD-focused OnTrack group vs. education-oriented KnowIt group', 'Randomized Distress Intervention']","['episodes of hypoglycemia and improved HbA 1c  over time', 'Diabetes Behavioral and Glycemic Outcomes', 'frequent insulin adjustment, improved problem-solving skills, more blood glucose monitoring, and greater adoption of continuous glucose monitoring', 'DD, self-care, and glycemic outcomes', 'glycemic outcomes', 'DD, self-care, HbA 1c , and frequency of hypoglycemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",301.0,0.0582158,"Fit indices indicated good fit of the model to the data (confirmatory fit index = 0.94, root mean square error of approximation = 0.05), with stronger and more meaningful associations for OnTrack than for KnowIt.
","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, San Francisco, CA danielle.hessler@ucsf.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Strycker', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, San Francisco, CA.'}]",Diabetes care,['10.2337/dc20-2724']
1229,33989786,A Preliminary Study of Provider Burden in the Treatment of Chronic Pain: Perspectives of Physicians and People with Chronic Pain.,"This study compared perceptions of the burden of patient care and associated clinical judgments between physicians and people with chronic pain (PWCP) in a 2 × 3 × 2 between-subjects design that varied participant type, patient-reported pain severity (4/6-8/10), and supporting medical evidence (low/high). One hundred and nine physicians and 476 American Chronic Pain Association members were randomly assigned to 1 of 6 conditions. Respondents estimated the clinical burden they would assume as the treating physician of a hypothetical patient with chronic low back pain, and made clinical judgments regarding that patient. Physician burden ratings were significantly higher than PWCP ratings, and clinical impressions (eg, trust in pain report, medical attribution) and management concerns (eg, opioid abuse risk) were relatively less favorable. Neither pain severity nor medical evidence affected burden ratings significantly. High medical evidence was associated with more favorable clinical impressions; higher pain severity led to more discounting of patient pain reports. Burden was significantly correlated with a range of clinical judgments. Results indicate that physicians and PWCP differ in their perceptions of provider burden and related clinical judgments in ways that could impact treatment collaboration. Further research is needed that examines provider burden in actual clinical practice. PERSPECTIVE: Physicians and people with chronic pain (PWCP) estimated the clinical burden of patient care and made judgments about a hypothetical patient with chronic pain. Physician burden ratings were higher and clinical judgments less favorable, relative to PWCP respondents. These differences could impact treatment collaboration and merit study in clinical practice.",2021,High medical evidence was associated with more favorable clinical impressions; higher pain severity led to more discounting of patient pain reports.,"['physicians and people with chronic pain (PWCP) in a 2\u202f×\u202f3\u202f×\u202f2 between-subjects design that varied participant type, patient-reported pain severity (4-6-8/10), and supporting medical evidence (low/high', 'Perspective Physicians and people with chronic pain (PWCP', 'Physicians and People with Chronic Pain', '109 physicians and 476 American Chronic Pain Association members']",[],"['Physician burden ratings', 'PWCP ratings, and clinical impressions (e.g., trust in pain report, medical attribution) and management concerns (e.g., opioid abuse risk']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]",[],"[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0029095', 'cui_str': 'Opioid abuse'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.132073,High medical evidence was associated with more favorable clinical impressions; higher pain severity led to more discounting of patient pain reports.,"[{'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Tait', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Saint Louis University School of Medicine, St. Louis, Missouri. Electronic address: raymond.tait@health.slu.edu.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Chibnall', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Saint Louis University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Kalauokalani', 'Affiliation': 'American Chronic Pain Association, Rocklin, California.'}]",The journal of pain,['10.1016/j.jpain.2021.04.009']
1230,34003726,Nurse-Led Palliative Care Clinical Trial Improves Knowledge and Preparedness in Caregivers of Patients with Idiopathic Pulmonary Fibrosis.,"Rationale:  Patients with idiopathic pulmonary fibrosis (IPF) and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life (EOL) care planning as the disease progresses. The hypothesis for this study was that the early introduction of palliative care in the course of IPF would improve knowledge and preparation for EOL, patient-reported outcomes, and advance care planning in patients with IPF and their caregivers.  Objectives:  We sought to determine the feasibility, acceptability, and efficacy of a nurse-led early palliative care intervention entitled ""A Program of SUPPORT"" (Symptom management, Understanding the disease, Pulmonary rehabilitation, Palliative care, Oxygen therapy, Research participation, and Transplantation) in patients with IPF and their caregivers.  Methods:  Patients with IPF (diagnosed in the year previous to their initial center visit) from the University of Pittsburgh Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease at University of Pittsburgh Medical Center-together with their caregivers-were randomized to receive the intervention ""A Program of SUPPORT"" or usual care. This included a total of three research visits aligned with their clinic visit over a period of 6 to 8 months. We measured feasibility, acceptability, and efficacy of this intervention.  Results:  A total of 136 patient/caregiver dyads were eligible, and a total of 76 dyads were enrolled and participated. Participants were predominately White males >65 years old. Thirteen percent did not have an identified caregiver. Feasibility was limited; 56% of eligible dyads were enrolled. Eligible dyads (24%) were interested in participating but too fatigued to stay after their clinic visit. There was high attrition (20% of participants died before the study was completed). ""A Program of SUPPORT"" was acceptable to participants. Efficacy demonstrated a significant improvement in caregiver's knowledge, disease preparedness, and confidence in caring for the patient as well as an improvement in knowledge and advance care planning completion in patient participants.  Conclusions:  Patients with IPF and their caregivers have unmet needs regarding knowledge of their disease, self-management strategies, and preparedness for EOL planning. This nurse-led intervention demonstrated acceptability and efficacy in knowledge and advance care planning completion in patients and in knowledge, disease preparedness, and confidence in caregivers. Future research should identify additional strategies, including telemedicine resources to reach additional patients and their caregivers earlier in their disease course. Clinical trial registered with clinicaltrials.gov (NCT02929017).",2021,"This nurse-led intervention demonstrated acceptability and efficacy on knowledge and advance care plan completion in patients and knowledge, disease preparedness, and confidence in caregivers.","['136 patient/caregiver dyads were eligible, and a total of 76 dyads were enrolled and participated', 'Eligible dyads (24%) were interested in participating, but too fatigued to stay after their clinic visit', 'Participants were predominately white males > 65 years old', 'patients and knowledge, disease preparedness, and confidence in caregivers', 'Caregivers of Patients with Idiopathic Pulmonary Fibrosis', 'patients with IPF and their caregivers', 'Patients with Idiopathic Pulmonary Fibrosis (IPF', 'Patients with Idiopathic Pulmonary Fibrosis, diagnosed in the previous year from their initial center visit, and their caregivers from the University of Pittsburgh Dorothy P. & Richard P. Simmons Center for Interstitial Lung Disease (ILD) at UPMC', 'IPF patients and their caregivers']","['intervention ""A Program of SUPPORT"" or usual care', 'Nurse-Led Palliative Care', 'nurse-led early palliative care intervention, entitled ""A Program of SUPPORT']","['feasibility, acceptability and efficacy', ""caregiver's knowledge, disease preparedness, and confidence in caring for the patient and an improvement in knowledge and advance care planning completion"", 'feasibility, acceptability, and efficacy']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",76.0,0.0887675,"This nurse-led intervention demonstrated acceptability and efficacy on knowledge and advance care plan completion in patients and knowledge, disease preparedness, and confidence in caregivers.","[{'ForeName': 'Kathleen Oare', 'Initials': 'KO', 'LastName': 'Lindell', 'Affiliation': 'University of Pittsburgh Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease at University of PMC and.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Klein', 'Affiliation': 'School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania; and.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Veatch', 'Affiliation': 'University of Pittsburgh Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease at University of PMC and.'}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Gibson', 'Affiliation': 'University of Pittsburgh Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease at University of PMC and.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Kass', 'Affiliation': 'University of Pittsburgh Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease at University of PMC and.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Nouraie', 'Affiliation': 'University of Pittsburgh Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease at University of PMC and.'}, {'ForeName': 'Margaret Q', 'Initials': 'MQ', 'LastName': 'Rosenzweig', 'Affiliation': 'School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania; and.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202012-1494OC']
1231,34006921,Delineating tesamorelin response pathways in HIV-associated NAFLD using a targeted proteomic and transcriptomic approach.,"NAFLD is a leading comorbidity in HIV with an exaggerated course compared to the general population. Tesamorelin has been demonstrated to reduce liver fat and prevent fibrosis progression in HIV-associated NAFLD. We further showed that tesamorelin downregulated hepatic gene sets involved in inflammation, tissue repair, and cell division. Nonetheless, effects of tesamorelin on individual plasma proteins pertaining to these pathways are not known. Leveraging our prior randomized-controlled trial and transcriptomic approach, we performed a focused assessment of 9 plasma proteins corresponding to top leading edge genes within differentially modulated gene sets. Tesamorelin led to significant reductions in vascular endothelial growth factor A (VEGFA, log 2 -fold change - 0.20 ± 0.35 vs. 0.05 ± 0.34, P = 0.02), transforming growth factor beta 1 (TGFB1, - 0.35 ± 0.56 vs. - 0.05 ± 0.43, P = 0.05), and macrophage colony stimulating factor 1 (CSF1, - 0.17 ± 0.21 vs. 0.02 ± 0.20, P = 0.004) versus placebo. Among tesamorelin-treated participants, reductions in plasma VEGFA (r = 0.62, P = 0.006) and CSF1 (r = 0.50, P = 0.04) correlated with a decline in NAFLD activity score. Decreases in TGFB1 (r = 0.61, P = 0.009) and CSF1 (r = 0.64, P = 0.006) were associated with reduced gene-level fibrosis score. Tesamorelin suppressed key angiogenic, fibrogenic, and pro-inflammatory mediators. CSF1, a regulator of monocyte recruitment and activation, may serve as an innovative therapeutic target for NAFLD in HIV. Clinical Trials Registry Number: NCT02196831.",2021,"Among tesamorelin-treated participants, reductions in plasma VEGFA (r = 0.62, P = 0.006) and CSF1 (r = 0.50, P = 0.04) correlated with a decline in NAFLD activity score.",[],"['NAFLD', 'placebo', 'Tesamorelin']","['TGFB1', 'transforming growth factor beta', 'plasma VEGFA', 'NAFLD activity score', 'CSF1', 'gene-level fibrosis score', 'vascular endothelial growth factor A (VEGFA', 'Tesamorelin suppressed key angiogenic, fibrogenic, and pro-inflammatory mediators']",[],"[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1876200', 'cui_str': 'tesamorelin'}]","[{'cui': 'C0080222', 'cui_str': 'TGFB1 protein, human'}, {'cui': 'C0040690', 'cui_str': 'Platelet Transforming Growth Factor'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3887672', 'cui_str': 'CSF1 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C1876200', 'cui_str': 'tesamorelin'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]",,0.154293,"Among tesamorelin-treated participants, reductions in plasma VEGFA (r = 0.62, P = 0.006) and CSF1 (r = 0.50, P = 0.04) correlated with a decline in NAFLD activity score.","[{'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street 5LON207, Boston, MA, 02114, USA.'}, {'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street 5LON207, Boston, MA, 02114, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Billingsley', 'Affiliation': 'Harvard Chan Bioinformatics Core, Department of Biostatistics, Harvard School of Public Health, Boston, MA, 02115, USA.'}, {'ForeName': 'Shannan J Ho', 'Initials': 'SJH', 'LastName': 'Sui', 'Affiliation': 'Harvard Chan Bioinformatics Core, Department of Biostatistics, Harvard School of Public Health, Boston, MA, 02115, USA.'}, {'ForeName': 'Meghan N', 'Initials': 'MN', 'LastName': 'Feldpausch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street 5LON207, Boston, MA, 02114, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Boutin', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street 5LON207, Boston, MA, 02114, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Zheng', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street 5LON207, Boston, MA, 02114, USA.'}, {'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'McClure', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street 5LON207, Boston, MA, 02114, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Corey', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, 02114, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, 02114, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Hadigan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, 02114, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street 5LON207, Boston, MA, 02114, USA. sgrinspoon@mgh.harvard.edu.'}]",Scientific reports,['10.1038/s41598-021-89966-y']
1232,34006912,Vagal reactivation after a cardiac rehabilitation session associated with hydration in coronary artery disease patients: crossover clinical trial.,"This study aimed to investigate the hydration influence on the autonomic responses of coronary artery disease subjects in the immediate recovery period after a cardiovascular rehabilitation session, in view of the risks of a delayed autonomic recovery for this population. 28 males with coronary artery disease were submitted to: (I) Maximum effort test; (II) Control protocol (CP), composed by initial rest, warm-up, exercise and passive recovery; (III) Hydration protocol (HP) similar to CP, but with rehydration during exercise. The recovery was evaluated through the heart rate (HR) variability, HR recovery and by the rate of perceived exertion and recovery. The main results revealed that the vagal reactivation occurred at the first 30 s of recovery in HP and after the first minute in CP. A better behavior of the HR at the first minute of recovery was observed in HP. The rate of perceived exertion had a significant decrease in the first minute of recovery in HP, while in CP this occurred after the third minute. In conclusion, despite an anticipated vagal reactivation found at HP, these results should be analyzed with caution as there were no significant differences between protocols for all variables and the effect sizes were small.",2021,"The rate of perceived exertion had a significant decrease in the first minute of recovery in HP, while in CP this occurred after the third minute.","['28 males with coronary artery disease were submitted to: (I', 'coronary artery disease patients', 'coronary artery disease subjects']","['Control protocol (CP), composed by initial rest, warm-up, exercise and passive recovery; (III) Hydration protocol (HP) similar to CP', 'cardiac rehabilitation session']","['vagal reactivation', 'Vagal reactivation', 'first minute of recovery in HP', 'rate of perceived exertion', 'heart rate (HR) variability, HR recovery and by the rate of perceived exertion and recovery']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",28.0,0.0547179,"The rate of perceived exertion had a significant decrease in the first minute of recovery in HP, while in CP this occurred after the third minute.","[{'ForeName': 'Maria Júlia Lopez', 'Initials': 'MJL', 'LastName': 'Laurino', 'Affiliation': 'Physical Therapy Post-graduation Program, Faculty of Science and Technology, São Paulo State University (UNESP), Rua Roberto Simonsen, 305, Presidente Prudente, São Paulo, 19060-900, Brazil. majulaurino@hotmail.com.'}, {'ForeName': 'Anne Kastelianne França', 'Initials': 'AKF', 'LastName': 'da Silva', 'Affiliation': 'Physical Therapy Post-graduation Program, Faculty of Science and Technology, São Paulo State University (UNESP), Rua Roberto Simonsen, 305, Presidente Prudente, São Paulo, 19060-900, Brazil.'}, {'ForeName': 'Lorena Altafin', 'Initials': 'LA', 'LastName': 'Santos', 'Affiliation': 'Physical Therapy Post-graduation Program, Faculty of Science and Technology, São Paulo State University (UNESP), Rua Roberto Simonsen, 305, Presidente Prudente, São Paulo, 19060-900, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': 'Physical Therapy Post-graduation Program, Faculty of Science and Technology, São Paulo State University (UNESP), Rua Roberto Simonsen, 305, Presidente Prudente, São Paulo, 19060-900, Brazil.'}, {'ForeName': 'Laís Manata', 'Initials': 'LM', 'LastName': 'Vanzella', 'Affiliation': 'Physical Therapy Post-graduation Program, Faculty of Science and Technology, São Paulo State University (UNESP), Rua Roberto Simonsen, 305, Presidente Prudente, São Paulo, 19060-900, Brazil.'}, {'ForeName': 'Dayane Andrade Genoni', 'Initials': 'DAG', 'LastName': 'Corazza', 'Affiliation': 'Physical Therapy Post-graduation Program, Faculty of Science and Technology, São Paulo State University (UNESP), Rua Roberto Simonsen, 305, Presidente Prudente, São Paulo, 19060-900, Brazil.'}, {'ForeName': 'Luiz Carlos Marques', 'Initials': 'LCM', 'LastName': 'Vanderlei', 'Affiliation': 'Physical Therapy Post-graduation Program, Faculty of Science and Technology, São Paulo State University (UNESP), Rua Roberto Simonsen, 305, Presidente Prudente, São Paulo, 19060-900, Brazil.'}]",Scientific reports,['10.1038/s41598-021-89840-x']
1233,34389407,Involved-Field Radiation Therapy Prevents Recurrences in the Early Stages of Hodgkin Lymphoma in PET-Negative Patients After ABVD Chemotherapy: Relapse Analysis of GHSG Phase 3 HD16 Trial.,"PURPOSE


The HD16 trial of the German Hodgkin Study Group (NCT00736320) demonstrated that radiation therapy in early-stage Hodgkin lymphoma without risk factors cannot be safely omitted, and therefore combined modality therapy (CMT) remains the standard treatment. To demonstrate the local effect of consolidating involved-field radiation therapy (IF-RT), we performed an analysis of the recurrence pattern of positron emission tomography (PET)-negative HD16 patients.
METHODS AND MATERIALS


Between 2009 and 2015, 1150 patients with early-stage Hodgkin lymphoma without risk factors were randomly assigned to PET guided to 20 Gy IF-RT after 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine chemotherapy in the HD16 study of the German Hodgkin Study Group. The study was designed as a prospective randomized controlled trial. We correlated the localization of recurrence with the panel-based IF-RT plan, which was drawn up for all patients prospectively, blinded to treatment allocation. Accordingly, we were able to identify recurrences that occurred at least in part inside or outside of the (potential) radiation field (in-field and out-field, respectively).
RESULTS


There were 328 and 300 PET-negative patients assigned to CMT and PET-guided treatment (ie, chemotherapy alone), respectively. Within a median 47-month follow-up, disease progression or recurrence was documented for 15 and 29 patients treated with and without IF-RT, respectively. Relapse localization was unknown in 1 CMT patient. Without IF-RT, 5-year incidence of in-field relapses was 10.5% (95% confidence interval, 6.5-14.6) compared with 2.4% (0.5-4.3) with CMT (P = .0008). There were no relevant differences in out-field recurrences (5-year incidence 4.1% [1.7-6.6] vs 6.6% [3.0-10.3], P = .54). There was no grade 4 toxicity observed during IF-RT, and incidence of second primary malignancies was similar in both groups.
CONCLUSIONS


PET-negative patients of the HD16 study showed no significant toxicity after 20 Gy IF-RT, and we demonstrated that omission of IF-RT resulted in more, particularly local, recurrences. Therefore, consolidation IF-RT should still be considered as standard therapy in this setting.",2021,"There were no relevant differences in out-field recurrences (5-year incidence 4.1% [1.7-6.6] vs. 6.6% [3.0-10.3], p=0.54).","[""early-stage Hodgkin's lymphoma without risk factors (ESHL"", 'Between 2009 and 2015 1150 patients with ESHL']","['radiotherapy', 'consolidating involved-field radiotherapy (IF-RT', 'PET guided to 20 Gy IFRT', 'ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) chemotherapy', 'RT', 'GHSG (xxxxxxxx']","['Relapse localization', 'toxicity', 'grade 4 toxicity', 'disease progression or recurrence', '5-year incidence of in-field relapses']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0050380', 'cui_str': 'ABVD-I protocol'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}]",,0.0449633,"There were no relevant differences in out-field recurrences (5-year incidence 4.1% [1.7-6.6] vs. 6.6% [3.0-10.3], p=0.54).","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baues', 'Affiliation': 'Department of Radiooncology, Radiotherapy and Cyberknife Center; German Hodgkin Study Group (GHSG). Electronic address: christian.baues@uk-koeln.de.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Goergen', 'Affiliation': 'German Hodgkin Study Group (GHSG).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'German Hodgkin Study Group (GHSG); Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Rosenbrock', 'Affiliation': 'Department of Radiooncology, Radiotherapy and Cyberknife Center; German Hodgkin Study Group (GHSG).'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Celik', 'Affiliation': 'Department of Radiooncology, Radiotherapy and Cyberknife Center.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eich', 'Affiliation': 'German Hodgkin Study Group (GHSG); Department of Radiotherapy, University Hospital of Muenster, Muenster, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Kobe', 'Affiliation': 'German Hodgkin Study Group (GHSG); Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Conrad-Amadeus', 'Initials': 'CA', 'LastName': 'Voltin', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'German Hodgkin Study Group (GHSG); Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'German Hodgkin Study Group (GHSG); Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Marnitz', 'Affiliation': 'Department of Radiooncology, Radiotherapy and Cyberknife Center; German Hodgkin Study Group (GHSG).'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.07.1697']
1234,34021043,Closed-Loop Neurofeedback of α Synchrony during Goal-Directed Attention.,"α Oscillations in sensory cortex, under frontal control, desynchronize during attentive preparation. Here, in a selective attention study with simultaneous EEG in humans of either sex, we first demonstrate that diminished anticipatory α synchrony between the mid-frontal region of the dorsal attention network and ventral visual sensory cortex [frontal-sensory synchrony (FSS)] significantly correlates with greater task performance. Then, in a double-blind, randomized controlled study in healthy adults, we implement closed-loop neurofeedback (NF) of the anticipatory α FSS signal over 10 d of training. We refer to this closed-loop experimental approach of rapid NF integrated within a cognitive task as cognitive NF (cNF). We show that cNF results in significant trial-by-trial modulation of the anticipatory α FSS measure during training, concomitant plasticity of stimulus-evoked α/θ responses, as well as transfer of benefits to response time (RT) improvements on a standard test of sustained attention. In a third study, we implement cNF training in children with attention deficit hyperactivity disorder (ADHD), replicating trial-by-trial modulation of the anticipatory α FSS signal as well as significant improvement of sustained attention RTs. These first findings demonstrate the basic mechanisms and translational utility of rapid cognitive-task-integrated NF. SIGNIFICANCE STATEMENT  When humans prepare to attend to incoming sensory information, neural oscillations in the α band (8-14 Hz) undergo desynchronization under the control of prefrontal cortex. Here, in an attention study with electroencephalography, we first show that frontal-sensory synchrony (FSS) of α oscillations during attentive preparation significantly correlates with task performance. Then, in a randomized controlled study in healthy adults, we show that neurofeedback (NF) training of this α FSS signal within the attention task is feasible. We show that this rapid cognitive NF (cNF) approach engenders plasticity of stimulus-evoked neural responses, and improves performance on a standard test of sustained attention. In a final study, we implement cNF in children with attention deficit hyperactivity disorder (ADHD), replicating the improvement of sustained attention found in adults.",2021,"We show that cNF results in significant trial-by-trial modulation of the anticipatory alpha FSS measure during training, concomitant plasticity of stimulus-evoked alpha/theta responses, as well as transfer of benefits to response time improvements on a standard test of sustained attention.","['children with ADHD', 'healthy adults']","['neurofeedback training', 'cNF training', 'rapid neurofeedback (NF) integrated within a cognitive task as cognitive neurofeedback (cNF']",['sustained attention response times'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]","[{'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0432896,"We show that cNF results in significant trial-by-trial modulation of the anticipatory alpha FSS measure during training, concomitant plasticity of stimulus-evoked alpha/theta responses, as well as transfer of benefits to response time improvements on a standard test of sustained attention.","[{'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, California 92037 jymishra@ucsd.edu.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Lowenstein', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California 94158.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Campusano', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California 94158.'}, {'ForeName': 'Yihan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Neural Engineering and Translation Labs, University of California San Diego, La Jolla, California 92037.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Diaz-Delgado', 'Affiliation': 'Neural Engineering and Translation Labs, University of California San Diego, La Jolla, California 92037.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Ayyoub', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California 94158.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California 94158.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gazzaley', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California 94158.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.3235-20.2021']
1235,34019729,Single-blind clinical trial: Sperm selection based on capacity to pass through cumulus oophorous column improves ICSI outcomes.,"BACKGROUND


Sperm selection procedures for future strategies that aim to select normal spermatozoa with intact DNA to improve intracytoplasmic sperm injection (ICSI) outcomes are in early developing stage.
OBJECTIVES


The objective is to find out whether the sperm selection procedure based on the ability of spermatozoa to traverse the cumulus cells could improve clinical outcomes of ICSI technique in infertile couples with male factor etiology.
MATERIALS AND METHODS


For this single-blind clinical trial, mature metaphase II oocytes were retrieved from 150 couples with male factor infertility, male age lower than 45 years and female age under 38 years. These couples were divided into two groups. In control group (n = 75), spermatozoa processed by density gradient centrifugation (DGC) were used to inject the oocytes. In the study group (n = 75), the oocytes were divided into sibling groups. In one sibling group (DGC), the oocytes were inseminated with DGC-processed spermatozoa while in the other group (DGC-CC), they were inseminated with DGC-processed spermatozoa that passed cumulus oophorous column.
RESULTS


Mean fertilization and embryo quality were significantly higher in DGC-CC group compared to DGC and control group. In addition, mean of chemical pregnancy (52.27% vs. 34.14%; p = 0.05), clinical pregnancy based on sac (52.27% vs. 32.92%; p = 0.03), clinical pregnancy with heart beat (52.27% vs. 25.60%; p = 0.003) and ongoing pregnancy (43.18% vs. 21.95%; p = 0.02) rates were significantly higher in DGC-CC group compared to control group.
CONCLUSION


Sperm selection based on integrated systems such as DGC and ability to pass through cumulus oophorous column could improve clinical outcomes of ICSI in couples with male factor infertility.",2021,"Mean fertilization and embryo quality were significantly higher in DGC-CC group compared to DGC and control group, respectively.","['150 couples with male factor infertility and male age lower than 45 years with women under 38', 'infertile couples with male factor etiology', 'couples with male factor infertility']",['sperm processed by density gradient centrifugation (DGC'],"['Mean fertilization and embryo quality', 'mean of chemical pregnancy', 'clinical pregnancy with heart beat', 'ongoing pregnancy', 'ICSI outcomes', 'clinical pregnancy based on sac']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0007704', 'cui_str': 'Centrifugation, Density Gradient'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0010834', 'cui_str': 'Cytoplasm'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",150.0,0.148287,"Mean fertilization and embryo quality were significantly higher in DGC-CC group compared to DGC and control group, respectively.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sabet', 'Affiliation': 'ACECR Institute of Higher Education (Isfahan Branch), Isfahan, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Najafi', 'Affiliation': 'Isfahan Fertility and Infertility Center, Isfahan, Iran.'}, {'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Tavalaee', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Nasr-Esfahani', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran.'}]",Andrology,['10.1111/andr.13043']
1236,33991326,"Pharmacokinetics and Comparative Bioavailability of Apomorphine Sublingual Film and Subcutaneous Apomorphine Formulations in Patients with Parkinson's Disease and ""OFF"" Episodes: Results of a Randomized, Three-Way Crossover, Open-Label Study.","INTRODUCTION


In a pivotal study, apomorphine sublingual film (APL; KYNMOBI ® ) was an effective and generally well-tolerated on-demand treatment of ""OFF"" episodes in patients with Parkinson's disease (PD), approved across the dose range of 10-30 mg. Pharmacokinetics and comparative bioavailability of APL and two subcutaneous (SC) apomorphine formulations (SC-APO [APOKYN ® ] and SC-APO-GO [APO-go ®  PEN]) were evaluated in a randomized, three-way crossover, open-label study (NCT03292016).
METHODS


Patients with PD and ""OFF"" episodes received an open-label randomized sequence of single doses of SC-APO and SC-APO-GO at the currently prescribed dose (2/3/4/5 mg) and APL doses with similar plasma exposure (15/20/25/30 mg) with ≥ 1-day washout between formulations. Plasma pharmacokinetics of apomorphine and apomorphine sulfate (major inactive metabolite) were measured 0-6 h postdose.
RESULTS


Median time to maximum plasma concentration (t max ) of apomorphine was 0.63-0.75 h for APL and 0.25-0.38 h for SC-APO and SC-APO-GO. Geometric mean maximum plasma concentration (C max ) of apomorphine was 4.31-11.2 ng/ml across APL doses and was generally lower compared with SC apomorphine formulations within dose groups. Area under the concentration-time curve from time 0 to infinity (AUC ∞ ) was similar across apomorphine formulations within most dose groups. Relative bioavailability of APL was ~ 17% of SC apomorphine by AUC ∞ ; SC-APO and SC-APO-GO had similar bioavailability (98% and 83% by AUC ∞  and C max , respectively). Apomorphine sulfate exposure was ~ three-fold higher for APL versus SC-APO and SC-APO-GO by AUC ∞  and C max .
CONCLUSION


In patients with PD and ""OFF"" episodes, APL demonstrated lower C max  and relative bioavailability but similar exposures (AUCs) versus SC apomorphine within the approved dose range.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03292016.",2021,"RESULTS


Median time to maximum plasma concentration (t max ) of apomorphine was 0.63-0.75 h for APL and 0.25-0.38 h for SC-APO and SC-APO-GO.","[""patients with Parkinson's disease (PD"", 'Patients with Parkinson\'s Disease and ""OFF"" Episodes', 'Patients with PD and ""OFF"" episodes']","['apomorphine sublingual film (APL; KYNMOBI ® ', 'Apomorphine Sublingual Film and Subcutaneous Apomorphine Formulations', 'APL and two subcutaneous (SC) apomorphine formulations (SC-APO [APOKYN ® ] and SC-APO-GO', 'apomorphine and apomorphine sulfate (major inactive metabolite', 'SC-APO and SC-APO-GO', 'APL doses with similar plasma exposure (15/20/25/30\xa0mg) with\u2009≥\u20091-day washout between formulations']","['Median time to maximum plasma concentration (t max ) of apomorphine', 'C max  and relative bioavailability', 'Apomorphine sulfate exposure', 'Geometric mean maximum plasma concentration (C max ) of apomorphine', 'Relative bioavailability of APL', 'bioavailability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C1589388', 'cui_str': 'Apokyn'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1704608', 'cui_str': 'Film'}]",,0.0765772,"RESULTS


Median time to maximum plasma concentration (t max ) of apomorphine was 0.63-0.75 h for APL and 0.25-0.38 h for SC-APO and SC-APO-GO.","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Agbo', 'Affiliation': 'Clinical Pharmacology, Modeling and Simulation, Sunovion Pharmaceuticals Inc., One Bridge Plaza North, Suite 510, Fort Lee, NJ, 07024, USA. Felix.Agbo@sunovion.com.'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Gil', 'Affiliation': ""Parkinson's Disease Treatment Center of Southwest Florida, Port Charlotte, FL, USA.""}, {'ForeName': 'Yu-Yuan', 'Initials': 'YY', 'LastName': 'Chiu', 'Affiliation': 'Clinical Pharmacology, Modeling and Simulation, Sunovion Pharmaceuticals Inc., One Bridge Plaza North, Suite 510, Fort Lee, NJ, 07024, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Brantley', 'Affiliation': 'Nuventra, Inc., Durham, NC, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Bhargava', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Navia', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",Neurology and therapy,['10.1007/s40120-021-00251-6']
1237,33988940,"Efficacy of Pulsed Radiofrequency or Short-Term Spinal Cord Stimulation for Acute/Subacute Zoster-Related Pain: A Randomized, Double-Blinded, Controlled Trial.","BACKGROUND


Postherpetic neuralgia (PHN) is the final stage of varicella zoster infection and a severe refractory neuropathic pain. Hence preventing transition of herpes zoster-related pain to PHN is a very important therapeutic principle for patients at an early stage, especially for older patients.Both pulsed radiofrequency (PRF) and short-term spinal cord stimulation (stSCS) have been proven to be effective to relieve acute/subacute zoster-related pain. However, which treatment could achieve better analgesic effects remains unclear.
OBJECTIVES


This study aimed to investigate the therapeutic efficacy and safety of PRF and stSCS in patients with acute/subacute zoster-related pain.
STUDY DESIGN


Prospective, randomized, double-blinded study.
SETTING


Department of Pain Medicine, the First Affiliated Hospital of China Medical University.
METHODS


Ninety-six patients with acute/subacute zoster-related pain were equally randomized into 2 groups: PRF group and stSCS group. Patients in the different groups were treated with high-voltage, long-duration PRF or stSCS. The therapeutic effects were evaluated using a Numeric Rating Scale (NRS-11) and the 36-Item Short Form Health Survey (SF-36) at different time points. The average dose of pregabalin (mg/d) administrated at different time points was also recorded.
RESULTS


The posttreatment NRS-11 scores in the 2 groups were significantly lower compared with baseline (P < 0.001). The NRS-11 scores in the stSCS group were significantly lower than those in the PRF group at 30 and 180 days after treatments (P < 0.05). The SF-36 scores of general health, social function, role-emotional, mental health, bodily pain, physical function, physical role, and vitality could be significantly improved at each time point after treatments in the 2 groups. Some SF-36 scores could be significantly improved at some time points in the stSCS group compared with the PRF group. The rescue drug (pregabalin) dosages were lower in the stSCS group than those in the PRF group at days 90 and 180 after treatments. There was no bleeding at the puncture site, infection, postoperative paresthesia, nerve injury, or any other serious adverse effects in either group.
LIMITATIONS


Single-center study, relatively small number of patients.
CONCLUSIONS


PRF and stSCS are both effective and safe therapeutic alternatives for patients with acute/subacute zoster-related pain, however, stSCS could achieve more pain relief and improvement of life quality compared with PRF.",2021,Some SF-36 scores could be significantly improved at some time points in the stSCS group compared with the PRF group.,"['Acute/Subacute Zoster-Related Pain', 'Department of Pain Medicine, the First Affiliated Hospital of China Medical University', 'patients with acute/subacute zoster-related pain', 'patients at an early stage, especially for older patients', 'Ninety-six patients with acute/subacute zoster-related pain']","['Pulsed Radiofrequency or Short-Term Spinal Cord Stimulation', 'pulsed radiofrequency (PRF) and short-term spinal cord stimulation (stSCS', 'pregabalin', 'PRF', 'PRF group and stSCS', 'PRF and stSCS']","['pain relief and improvement of life quality', 'SF-36 scores', 'therapeutic efficacy and safety', 'bleeding at the puncture site, infection, postoperative paresthesia, nerve injury, or any other serious adverse effects', 'posttreatment NRS-11 scores', 'Numeric Rating Scale (NRS-11) and the 36-Item Short Form Health Survey (SF-36', 'NRS-11 scores', 'rescue drug (pregabalin) dosages', 'SF-36 scores of general health, social function, role-emotional, mental health, bodily pain, physical function, physical role, and vitality']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",96.0,0.140912,Some SF-36 scores could be significantly improved at some time points in the stSCS group compared with the PRF group.,"[{'ForeName': 'Cheng-Fu', 'Initials': 'CF', 'LastName': 'Wan', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital of China Medical University, Shenyang City, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital of China Medical University, Shenyang City, China.'}]",Pain physician,[]
1238,33992767,Peer navigation for smoking cessation in smokers with HIV: Protocol for a randomized clinical trial.,"BACKGROUND


Smoking prevalence in persons with HIV (PWH) is high (40%) and cessation rates remain low. Lack of social support and poor adherence to nicotine replacement therapy (NRT) are related to poor cessation outcomes; thus, both factors represent possible targets for smoking cessation interventions. Peer navigators (PNs) have been integrated into HIV care with great success to improve engagement and adherence to antiretroviral therapy. However, no clinical trial has evaluated the potential for PNs to provide social support and improve NRT adherence for smoking cessation. We developed a treatment protocol that targets social support, adherence, and self-efficacy for quitting by incorporating PNs into a smoking cessation program. This randomized trial will test whether this approach results in higher rates of 7-day point prevalence abstinence at 12- and 24-weeks, compared to standard treatment.
METHODS


Seventy-two smokers with HIV will be randomized to either Peer Navigation Social Support for smoking cessation (PNSS-S) or standard cessation counseling. All participants will meet with a nurse for a smoking cessation counseling session, which will include discussion of FDA-approved cessation pharmacotherapy. Participants assigned to PNSS-S will receive weekly phone calls from the PN for 12 weeks. The PN will address readiness to quit, using medication to quit, common barriers to cessation, high risk situations, slip management, and maintaining abstinence. Smoking cessation outcomes will be measured at 4, 12, and 24 weeks following the baseline appointment.
CONCLUSION


Results from this study will provide preliminary evidence of whether incorporating a peer navigator-based intervention into smoking cessation treatment can improve smoking cessation outcomes in PWH.",2021,Peer navigators (PNs) have been integrated into HIV care with great success to improve engagement and adherence to antiretroviral therapy.,"['Seventy-two smokers with HIV', 'smokers with HIV', 'persons with HIV (PWH']","['Peer Navigation Social Support for smoking cessation (PNSS-S) or standard cessation counseling', 'nicotine replacement therapy (NRT', 'Peer navigation', 'Peer navigators (PNs']","['NRT adherence', 'smoking cessation outcomes', 'Smoking cessation outcomes', 'higher rates of 7-day point prevalence abstinence']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",72.0,0.0728518,Peer navigators (PNs) have been integrated into HIV care with great success to improve engagement and adherence to antiretroviral therapy.,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America. Electronic address: Patricia_Cioe@brown.edu.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Pinkston', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, United States of America; Department of Medicine, Warren Alpert Medical School of Brown University, Providence, RI, United States of America.'}, {'ForeName': 'Karen T', 'Initials': 'KT', 'LastName': 'Tashima', 'Affiliation': 'Division of Infectious Diseases, Alpert Medical School of Brown University, Providence, RI, United States of America.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106435']
1239,34004347,The Effect of Literacy-Adapted Psychosocial Treatments on Biomedical and Biopsychosocial Pain Conceptualization.,"This is a secondary data analysis of a subgroup of participants who received the Learning About My Pain (LAMP) intervention (clinicaltrials.gov identifier NCT01967342). We examined the effects of LAMP on pre-to-post changes in biomedical and biopsychosocial pain conceptualization and whether those changes in pain conceptualization were associated with physical and psychological functioning. Participants were randomized into three conditions: Cognitive Behavioral Therapy (CBT), Pain Psychoeducation (EDU), or Usual Medical Care (UC). Results based on 225 participants who completed the Pain Concepts Questionnaire (PCQ) showed a pre-to-post reduction in biomedical pain conceptualization (BM), an increase in biopsychosocial pain conceptualization (BPS), and an increase in BPS/BM ratio for CBT and EDU but not UC. There were no differences between CBT and EDU in post-treatment PCQ scores. Compared to those with lower BM pain beliefs scores at post-treatment, participants endorsing higher BM pain beliefs scores reported greater pain intensity and greater pain interference. Furthermore, higher BM pain beliefs scores at post-treatment and lower BPS/BM ratio were associated with higher levels of pain catastrophizing. Overall, results of this study suggest the need for targeting specific pain beliefs that influence pain-related outcomes. PERSPECTIVE: This article presents the potential benefits of providing literacy-adapted psychosocial treatments to expand pain conceptualization beyond a biomedical-only understanding and toward a biopsychosocial conceptualization of the experience of pain. Furthermore, the association of changes in pain conceptualization and pain-related functioning argues for its potential clinical relevance.",2021,There were no differences between CBT and EDU in post-treatment PCQ scores.,['225 participants who completed the'],"['Learning About My Pain (LAMP) interventions', 'Cognitive Behavioral Therapy (CBT), Pain Psychoeducation (EDU), or Usual Medical Care (UC', 'LAMP', 'Literacy-Adapted Psychosocial Treatments']","['Pain Concepts Questionnaire (PCQ', 'higher BM pain beliefs scores', 'BPS/BM ratio', 'Biomedical and Biopsychosocial Pain Conceptualization', 'BM pain beliefs scores', 'biopsychosocial pain conceptualization (BPS', 'pain intensity and greater pain interference', 'pain catastrophizing']","[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0589138', 'cui_str': 'Conceptualization'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}]",225.0,0.183092,There were no differences between CBT and EDU in post-treatment PCQ scores.,"[{'ForeName': 'Calia A', 'Initials': 'CA', 'LastName': 'Morais', 'Affiliation': 'Pain Research and Intervention Center of Excellence (PRICE), Department of Community Dentistry and Behavioral Sciences, College of Dentistry, University of Florida, Gainesville, Florida; Center for Pain Research and Behavioral Health, Department of Clinical and Health Psychology, University of Florida, Florida. Electronic address: cmorais@dental.ufl.edu.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Newman', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Van Dyke', 'Affiliation': 'Department of Psychology, Young Harris College, Young Harris, Georgia.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Thorn', 'Affiliation': 'Department of Psychology, The University of Alabama, Tuscaloosa, Alabama.'}]",The journal of pain,['10.1016/j.jpain.2021.04.005']
1240,34008397,"Comparative efficacy of early morning versus bedtime administration of levothyroxine in children with hypothyroidism: a prospective, open label, randomized, case-control study.","INTRODUCTION


Studies in adults with hypothyroidism suggest an equal efficacy of bedtime versus early morning intake of levothyroxine. There is limited data on timing of levothyroxine administration in children.
MATERIAL AND METHODS


Children with hypothyroidism on early morning levothyroxine, and clinically and biochemically euthyroid, were assigned to receive levothyroxine at bedtime (group A) or were continued on early morning levothyroxine intake (group B). Clinical, anthropometric and laboratory evaluation (thyroid and lipid profiles, liver enzymes and creatinine) was done at baseline, and at 3 and 6 months.
RESULTS


Eighty-four children, 42 in each group, completed the study. The clinical and anthropometric parameters remained similar in the two groups at baseline and at 3- and 6-month follow-up visits. There was no difference in the mean serum concentrations of triiodothyronine, thyroxine and thyrotropin at the 3 time-points in the study. In addition, mean serum aspartate transaminase, alanine transaminase, creatinine and parameters of lipid profiles remained similar in the two groups. The requirement of levothyroxine was similar at baseline (48.6 ±16.9 µg vs. 49.6 ±19.5 µg, p-value 0.80) and at the endpoint (48.3 ±17.2 µg vs. 51.9 ±18.0 µg, p-value 0.46) in both groups. At the study end, 25 (60%) patients in group A and 17 (40%) in group B preferred bedtime dosing of levothyroxine.
CONCLUSIONS


We found an equal efficacy of bedtime intake compared to early morning intake of levothyroxine in maintaining an euthyroid state in children with hypothyroidism. Further studies are required to see if bedtime levothyroxine administration improves the quality of life of patients.",2021,"There was no difference in the mean serum concentrations of triiodothyronine, thyroxine and thyrotropin at the 3 time-points in the study.","['children', 'Children with hypothyroidism on early morning levothyroxine, and clinically and biochemically euthyroid', 'children with hypothyroidism', 'adults with hypothyroidism', 'Eighty-four children, 42 in each group, completed the study']","['levothyroxine at bedtime (group A) or were continued on early morning levothyroxine intake', 'levothyroxine']","['Clinical, anthropometric and laboratory evaluation (thyroid and lipid profiles, liver enzymes and creatinine', 'mean serum aspartate transaminase, alanine transaminase, creatinine and parameters of lipid profiles', 'quality of life', 'mean serum concentrations of triiodothyronine, thyroxine and thyrotropin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0117002', 'cui_str': 'Euthyroid'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]",84.0,0.0809017,"There was no difference in the mean serum concentrations of triiodothyronine, thyroxine and thyrotropin at the 3 time-points in the study.","[{'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Navid', 'Affiliation': 'Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Dayal', 'Affiliation': 'Endocrinology and Diabetes Unit, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Harvinder', 'Initials': 'H', 'LastName': 'Kaur', 'Affiliation': 'Growth and Anthropology Unit, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Endocrinology and Diabetes Unit, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Attri', 'Affiliation': 'Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]","Pediatric endocrinology, diabetes, and metabolism",['10.5114/pedm.2021.105635']
1241,34007017,Outcomes of older men receiving docetaxel for metastatic hormone-sensitive prostate cancer.,"BACKGROUND


Most men who die of prostate cancer are older than 70 years. The ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) randomized men of all ages with metastatic hormone-sensitive prostate cancer (mHSPC) to receive androgen deprivation therapy (ADT) with or without docetaxel demonstrating an overall survival (OS) benefit for docetaxel.
METHODS


In a post-hoc analysis of this trial, we assessed patient characteristics and OS in patients ≥70 years (""older men"") versus <70 years (""younger men"") with Cox proportional hazards models. In addition, we compared adverse events, therapy completion rate, and subsequent treatment patterns between these two groups using Chi-squared tests.
RESULTS


177 (22.4%) patients were ≥70 years. Docetaxel + ADT resulted in improved OS in both older and younger men (Hazard Ratio [HR] 0.45, 95%CI: 0.25-0.80 for older men; HR 0.71, 95%CI: 0.53-0.95 for younger men). This treatment benefit was seen for subgroups of older men with high volume disease (HR 0.43, 95%CI 0.23-0.79) and de novo metastatic disease (HR 0.36, 95%CI 0.19-0.69). A similar proportion of older and younger men completed six cycles of docetaxel (82.6% vs. 87.1%, p = 0.28). Rates of grade 3-5 adverse events were similar between older and younger men (36.8% vs. 26.8%, respectively, p = 0.069). The rate of any Grades 4-5 adverse events did not differ significantly between older and younger men (14.9% vs. 11.9%, respectively, p = 0.46). In the control arm, a smaller proportion of older men received subsequent cancer treatments (34.4% vs. 51.5%, p = 0.017) or subsequent docetaxel (25.6% vs. 37.6%, p = 0.035) compared to younger men.
CONCLUSIONS


Older men with mHSPC had similar OS benefit and clinical outcomes compared to younger men when receiving docetaxel + ADT. Oncologists should consider docetaxel chemotherapy as a favorable treatment option for older men with mHSPC who are fit for chemotherapy.",2021,"Docetaxel + ADT resulted in improved OS in both older and younger men (Hazard Ratio [HR] 0.45, 95%CI: 0.25-0.80 for older men; HR 0.71, 95%CI:","['Extensive Disease in Prostate Cancer (CHAARTED) randomized men of all ages with metastatic hormone-sensitive prostate cancer (mHSPC', 'Older men with', 'for metastatic hormone-sensitive prostate cancer', 'patients ≥70 years (""older men"") versus <70 years (""younger men"") with Cox proportional hazards models', 'older men with mHSPC who are fit for chemotherapy', 'older men receiving', 'men who die of prostate cancer are older than 70 years', '177 (22.4%) patients were ≥70 years']","['docetaxel', 'docetaxel chemotherapy', 'androgen deprivation therapy (ADT) with or without docetaxel', 'Docetaxel + ADT', 'mHSPC', 'docetaxel\u2009+\u2009ADT']","['rate of any Grades 4-5 adverse events', 'Rates of grade 3-5 adverse events', 'adverse events, therapy completion rate, and subsequent treatment patterns', 'OS']","[{'cui': 'C0849867', 'cui_str': 'Generalized illness'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0010235', 'cui_str': 'Cox Proportional Hazards Models'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.208548,"Docetaxel + ADT resulted in improved OS in both older and younger men (Hazard Ratio [HR] 0.45, 95%CI: 0.25-0.80 for older men; HR 0.71, 95%CI:","[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Lage', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA. dlage@mgh.harvard.edu.'}, {'ForeName': 'M Dror', 'Initials': 'MD', 'LastName': 'Michaelson', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Lee', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-021-00389-2']
1242,34018052,Effects of very low-carbohydrate vs. high-carbohydrate weight loss diets on psychological health in adults with obesity and type 2 diabetes: a 2-year randomized controlled trial.,"AIMS


Very low-carbohydrate (LC) diets are popular for type 2 diabetes (T2DM) management; however, long-term effects on psychological health remain largely unknown. This study reports the effects of a LC diet on mood and cognitive function after 2 years and explores the potential predictors of changes in psychological health.
METHODS


115 adults (57% males; age: 58.5 ± 7.1 years) with obesity and T2DM were randomized to consume an energy reduced (~ 500 to 1000 kcal/day deficit), LC diet [14% energy as carbohydrate, 28% protein, 58% fat (< 10% saturated fat)] or an isocaloric high unrefined carbohydrate, low-fat diet [HC: 53% carbohydrate, 17% protein, 30% fat (< 10% saturated fat)] for 2 years. Both diets were combined with aerobic/resistance exercise (1 h, 3 days/week). Mood/well-being [Beck Depression Inventory (BDI), Spielberger State Anxiety Inventory (SAI), Profile of Mood States (POMS)], diabetes-related quality of life [Diabetes-39 (D-39)] and distress [Problem Areas in Diabetes (PAID) Questionnaire], and cognitive function were assessed during and post-intervention.
RESULTS


61 (LC: 33, HC: 28) participants completed the study. Weight loss was 9.1% after 12 months and 6.7% after 2 years with no difference between diet groups. There were no differences between the groups for the changes in any psychological health outcome (smallest p ≥ 0.19 for all time x diet interactions). Overtime, improvements in BDI, POMS [Total Mood Disturbance (TMD); four subscales], PAID, and D-39 (three subscales) scores occurred (p ≤ 0.05, time). Stepwise regression analysis showed improvements in BDI, POMS (TMD; two subscales), D-39, SAI, and PAID scores were significantly (p < 0.05) correlated with reductions in body weight and glycated hemoglobin.
CONCLUSION


In adults with obesity and T2DM, energy-restricted LC and HC diets produced comparable long-term improvements on a comprehensive range of psychological health outcomes. The findings suggest both diets can be used as a diabetes management strategy as part of a holistic lifestyle modification program without concern of negative effects on mental well-being or cognition.
TRIAL REGISTRATION


ACTRN12612000369820, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362168&isReview=true . Data described in the manuscript, code book, and analytic code will not be made available because approval has not been granted by participants.",2021,"Stepwise regression analysis showed improvements in BDI, POMS (TMD; two subscales), D-39, SAI, and PAID scores were significantly (p < 0.05) correlated with reductions in body weight and glycated hemoglobin.
","['115 adults (57% males; age: 58.5\u2009±\u20097.1\xa0years) with obesity and T2DM', ' 28) participants completed the study', '61 (LC: 33, HC', 'adults with obesity and type 2 diabetes']","['LC diet', 'very low-carbohydrate vs. high-carbohydrate weight loss diets', 'low-carbohydrate (LC) diets', 'aerobic/resistance exercise']","['BDI, POMS (TMD; two subscales), D-39, SAI, and PAID scores', 'mood and cognitive function', 'Mood/well-being [Beck Depression Inventory (BDI), Spielberger State Anxiety Inventory (SAI), Profile of Mood States (POMS', 'Weight loss', 'psychological health', 'psychological health outcome', 'body weight and glycated hemoglobin', ' diabetes-related quality of life [Diabetes-39 (D-39)] and distress [Problem Areas in Diabetes (PAID) Questionnaire], and cognitive function', 'BDI, POMS [Total Mood Disturbance (TMD); four subscales], PAID, and D-39 (three subscales) scores']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",115.0,0.0200655,"Stepwise regression analysis showed improvements in BDI, POMS (TMD; two subscales), D-39, SAI, and PAID scores were significantly (p < 0.05) correlated with reductions in body weight and glycated hemoglobin.
","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kakoschke', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation-Health and Biosecurity, Adelaide, SA, Australia.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Zajac', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation-Health and Biosecurity, Adelaide, SA, Australia.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Tay', 'Affiliation': 'A-Star Singapore-Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Luscombe-Marsh', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation-Health and Biosecurity, Adelaide, SA, Australia.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': ""Freemasons Foundation Centre for Men's Health, Faculty of Health Sciences, University of Adelaide, Adelaide, SA, Australia.""}, {'ForeName': 'Manny', 'Initials': 'M', 'LastName': 'Noakes', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation-Health and Biosecurity, Adelaide, SA, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Buckley', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': ""Freemasons Foundation Centre for Men's Health, Faculty of Health Sciences, University of Adelaide, Adelaide, SA, Australia.""}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Brinkworth', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Adelaide, SA, Australia. grant.brinkworth@csiro.au.'}]",European journal of nutrition,['10.1007/s00394-021-02587-z']
1243,34016615,Comment on Neeland et al. The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care 2020;43:3007-3015.,,2021,,[],['Empagliflozin'],['Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes'],[],"[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0912167,,"[{'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Brikman', 'Affiliation': 'Department of Internal Medicine E, HaEmek Medical Center, Afula, Israel sbrikman@gmail.com shay_br@clalit.org.il.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Dori', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}]",Diabetes care,['10.2337/dc21-0310']
1244,34016612,Effects of Cotadutide on Metabolic and Hepatic Parameters in Adults With Overweight or Obesity and Type 2 Diabetes: A 54-Week Randomized Phase 2b Study.,"OBJECTIVE


Cotadutide, a dual GLP-1 and glucagon receptor agonist, is under development for nonalcoholic steatohepatitis (NASH) and chronic kidney disease with type 2 diabetes. The effects of cotadutide on hepatic and metabolic parameters were evaluated in participants with overweight/obesity and type 2 diabetes.
RESEARCH DESIGN AND METHODS


In this phase 2b study, 834 adults with BMI ≥25 kg/m 2  and type 2 diabetes inadequately controlled with metformin (glycated hemoglobin A 1c  [HbA 1c ] of 7.0%-10.5% [53-91 mmol/mol]) were randomized to double-blind cotadutide 100 μg ( n  = 100), 200 μg ( n  = 256), or 300 μg ( n  = 256); placebo ( n  = 110); or open-label liraglutide 1.8 mg ( n  = 110)-all administered subcutaneously. Coprimary end points were changes in HbA 1c  and body weight at week 14. The originally randomized interventions were continued to week 54. Liver damage biomarkers and liver fibrosis algorithms were assessed.
RESULTS


Cotadutide significantly decreased HbA 1c  and body weight at weeks 14 and 54 versus placebo (all  P  < 0.001). Improvements in lipid profile, AST and ALT levels, propeptide of type III collagen level, fibrosis-4 index, and nonalcoholic fatty liver disease fibrosis score were observed with cotadutide 300 μg versus placebo, but not with liraglutide. Weight loss with cotadutide 200 μg was similar to that with liraglutide 1.8 mg and greater with cotadutide 300 μg versus liraglutide 1.8 mg. The most common adverse events with cotadutide (nausea, 35%; vomiting, 17%) decreased over time.
CONCLUSIONS


Cotadutide treatment for 54 weeks improved glycemic control and weight loss in participants with overweight/obesity and type 2 diabetes. Ad hoc analyses demonstrated improvements in hepatic parameters and support further evaluation of cotadutide in NASH.",2021,"RESULTS


Cotadutide significantly decreased HbA 1c  and body weight at weeks 14 and 54 versus placebo (all  P  < 0.001).","['Adults With Overweight or Obesity and Type 2 Diabetes', '834 adults with BMI ≥25 kg/m 2  and type 2 diabetes inadequately controlled with', 'participants with overweight/obesity and type 2 diabetes']","['liraglutide', 'metformin (glycated hemoglobin', 'cotadutide', 'placebo', 'Cotadutide', 'open-label liraglutide 1.8 mg ( n  = 110)-all administered subcutaneously']","['lipid profile, AST and ALT levels, propeptide of type III collagen level, fibrosis-4 index, and nonalcoholic fatty liver disease fibrosis score', 'vomiting, 17%) decreased over time', 'changes in HbA 1c  and body weight', 'HbA 1c  and body weight', 'hepatic parameters', 'Weight loss', 'Liver damage biomarkers and liver fibrosis algorithms', 'hepatic and metabolic parameters', 'glycemic control and weight loss', 'Metabolic and Hepatic Parameters']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C4304377', 'cui_str': 'Fibrosis-4 index'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0151763', 'cui_str': 'Liver damage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",834.0,0.0923389,"RESULTS


Cotadutide significantly decreased HbA 1c  and body weight at weeks 14 and 54 versus placebo (all  P  < 0.001).","[{'ForeName': 'Rajaa', 'Initials': 'R', 'LastName': 'Nahra', 'Affiliation': 'Clinical Metabolism, Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD rajaa.nahra@astrazeneca.com.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Clinical Biostatistics, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Kishore M', 'Initials': 'KM', 'LastName': 'Gadde', 'Affiliation': 'Clinical Trials Unit, Pennington Biomedical Research Center, Baton Rouge, LA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'Clinical Metabolism, Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stumvoll', 'Affiliation': 'Division of Endocrinology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Jermutus', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Cambridge, U.K.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Hirshberg', 'Affiliation': 'Research and Early Development, Early CVRM, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ambery', 'Affiliation': 'Clinical Metabolism, Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",Diabetes care,['10.2337/dc20-2151']
1245,34024811,Influence of respiration frequency on heart rate variability parameters: A randomized cross-sectional study.,"BACKGROUND


Many patients visiting physiotherapists for musculoskeletal disorders face psychosocial challenges which may form a large barrier to recover. There are only a limited number of evidence based psychosocial therapies, but they are mainly based on breathing exercises.
OBJECTIVE


to study which respiration frequency would lead to the highest relaxation, reflected in vagal tone derived from the heart rate variability (HRV) in healthy subjects.
METHODS


A randomized controlled cross sectional study was performed. Respiration cycles of four, five, six, seven and eight breaths per minute (BPM) were delivered in randomized order for two minutes each. HRV metrics were measured during the sessions with electrocardiogram (ECG). Repeated Measures ANOVA's were performed to analyze differences between breathing frequencies.
RESULTS


100 healthy volunteers were included (40 male). Standard Deviation of inter beat intervals (SDNN) values were significantly highest at 5 BPM, whereas the Root Mean Square of Successive Differences (RMSSD) values appeared highest at 7 breaths per minute (p< 0.01). High Frequency (HF) power was lowest at 4 BPM, whereas Low Frequency (LF) power was not significantly influenced by respiration frequency.
CONCLUSIONS


Breathing at a frequency of 5 to 7 breaths per minute leads to highest HRV values, but there is no single respiration ratio that maximizes all metrics. Physiotherapists may use five to seven BPM as guidance to determine ideal breathing frequencies.",2021,"High Frequency (HF) power was lowest at 4 BPM, whereas Low Frequency (LF) power was not significantly influenced by respiration frequency.
","['healthy subjects', '100 healthy volunteers were included (40 male']",[],"['Standard Deviation of inter beat intervals (SDNN) values', 'HRV metrics', 'eight breaths per minute (BPM', 'Low Frequency (LF) power', 'High Frequency (HF) power', 'Root Mean Square of Successive Differences (RMSSD) values']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0439386', 'cui_str': 'breaths/min'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}]",100.0,0.0177585,"High Frequency (HF) power was lowest at 4 BPM, whereas Low Frequency (LF) power was not significantly influenced by respiration frequency.
","[{'ForeName': 'Remko', 'Initials': 'R', 'LastName': 'Soer', 'Affiliation': 'Saxion University of Applied Sciences, Faculty of Health and Physical Activity, Enschede, The Netherlands.'}, {'ForeName': 'Marianne W M C', 'Initials': 'MWMC', 'LastName': 'Six Dijkstra', 'Affiliation': 'Saxion University of Applied Sciences, Faculty of Health and Physical Activity, Enschede, The Netherlands.'}, {'ForeName': 'Hendrik J', 'Initials': 'HJ', 'LastName': 'Bieleman', 'Affiliation': 'Saxion University of Applied Sciences, Faculty of Health and Physical Activity, Enschede, The Netherlands.'}, {'ForeName': 'Frits G J', 'Initials': 'FGJ', 'LastName': 'Oosterveld', 'Affiliation': 'Saxion University of Applied Sciences, Faculty of Health and Physical Activity, Enschede, The Netherlands.'}, {'ForeName': 'Noortje H M', 'Initials': 'NHM', 'LastName': 'Rijken', 'Affiliation': 'Saxion University of Applied Sciences, Faculty of Health and Physical Activity, Enschede, The Netherlands.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200190']
1246,34390283,Health-Related Quality of Life in Cancer Survivors with Chemotherapy-Induced Peripheral Neuropathy: A Randomized Clinical Trial.,"BACKGROUND


Chemotherapy-induced peripheral neuropathy (CIPN) is a common, debilitating adverse effect of neurotoxic chemotherapy that significantly worsens the quality of life of cancer survivors.
MATERIALS AND METHODS


Survivors of solid tumors with persistent moderate-to-severe CIPN defined as numbness, tingling, or pain rated ≥4 on an 11-point numeric rating scale (NRS) were randomized in a 1:1:1 ratio to 8 weeks of real acupuncture (RA) versus sham acupuncture (SA) versus usual care (UC). We previously reported the primary endpoint (NRS); here we report the following health-related quality of life endpoints: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), Hospital Anxiety and Depression Scale (HADS), Insomnia Severity Index (ISI), and Brief Fatigue Inventory (BFI). For each endpoint, the mean changes from baseline and 95% confidence intervals were estimated within each arm and compared between arms using linear mixed models.
RESULTS


We enrolled 75 survivors of solid tumors with moderate-to-severe CIPN into the study. Compared with baseline, at week 8, FACT/GOG-Ntx, HADS anxiety, and ISI scores significantly improved in RA and SA, but not in UC. Compared with UC, at week 8, FACT/GOG-Ntx scores significantly increased in RA and SA arms indicating improved CIPN-related symptoms and quality of life (p = .001 and p = .01). There was no statistically significant difference between RA and SA. There was no difference in HADS depression or BFI among RA, SA, and UC at weeks 8 and 12.
CONCLUSION


Acupuncture may improve CIPN-related symptoms and quality of life in cancer survivors with persistent CIPN. Further large sample size studies are needed to delineate placebo effects.
IMPLICATIONS FOR PRACTICE


The authors conducted a randomized sham acupuncture- and usual care-controlled clinical trial to evaluate the impact of acupuncture on health-related quality of life outcomes in patients with solid tumors with chemotherapy-induced peripheral neuropathy (CIPN). Statistically significant improvements in quality of life, anxiety, insomnia, and fatigue were achieved with 8 weeks of real acupuncture when compared with baseline, without statistically significant differences between real and sham acupuncture. These findings suggest that acupuncture may be effective for improving CIPN-related symptoms and quality of life and reducing anxiety and insomnia in cancer survivors with persistent CIPN, with further study needed to delineate placebo effects.",2021,"There was no difference in HADS depression or BFI among RA, SA, and UC at weeks 8 and 12.
CONCLUSION


Acupuncture may improve CIPN-related symptoms and quality of life in cancer survivors with persistent CIPN.","['solid tumor patients with chemotherapy-induced peripheral neuropathy (CIPN', 'Cancer Survivors with Chemotherapy-Induced Peripheral Neuropathy', 'enrolled 75 solid tumor survivors with moderate to severe CIPN into the study', 'cancer survivors with persistent CIPN', 'Solid tumor survivors with persistent moderate-to-severe CIPN defined as numbness, tingling, or pain rated ≥4 on an 11-point numeric rating scale (NRS']","['acupuncture', 'Acupuncture', 'real acupuncture (RA) versus sham acupuncture (SA) versus usual care (UC', 'neurotoxic chemotherapy']","['health-related quality of life endpoints: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity', 'FACT/GOG-Ntx), Hospital Anxiety and Depression Scale (HADS), Insomnia Severity Index (ISI), and Brief Fatigue Inventory (BFI', 'FACT/GOG-Ntx scores', 'HADS depression or BFI', 'quality of life, anxiety, insomnia, and fatigue', 'FACT/GOG-Ntx, HADS anxiety, and ISI scores', 'CIPN-related symptoms and quality of life', 'health-related quality of life outcomes']","[{'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",75.0,0.138446,"There was no difference in HADS depression or BFI among RA, SA, and UC at weeks 8 and 12.
CONCLUSION


Acupuncture may improve CIPN-related symptoms and quality of life in cancer survivors with persistent CIPN.","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Bao', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Baser', 'Affiliation': 'Department of Epidemiology and Biostatics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, New York University Winthrop Hospital, Mineola, New York, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Weitzman', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Yi Lily', 'Initials': 'YL', 'LastName': 'Zhang', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Seluzicki', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Qing Susan', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Piulson', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'W Iris', 'Initials': 'WI', 'LastName': 'Zhi', 'Affiliation': 'Breast Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, Commack, New York, USA.'}]",The oncologist,['10.1002/onco.13933']
1247,33988948,Can Additional Facet Joint Block Improve the Clinical Outcome of Kyphoplasty for Acute Osteoporotic Vertebral Compression Fractures?,"BACKGROUND


Percutaneous kyphoplasty (PKP) has been reported to provide a favorable analgesic effect for pain caused by osteoporotic vertebral compression fractures (OVCFs). However, a systematic review demonstrated that pain relief was only reported for approximately 86% of kyphoplasty treatments.
OBJECTIVES


To explore whether an additional facet joint block (FJB) can minimize pain and improve the clinical outcome of PKP in patients with acute OVCFs.
STUDY DESIGN


Prospective study.
SETTING


All data were from Honghui Hospital in Xi'an.
METHODS


According to the inclusion and exclusion criteria, 194 patients were eventually included in our study; they were randomly divided into 2 groups of 97 patients each and treated with either PKP + FJB or PKP alone. Follow-up consultations were scheduled 1 day, 3 days, 1 week, 1 month, 3 months, and 1 year postoperatively; the demographic characteristics, related surgical information, and complications observed within both groups were recorded. The clinical evaluation parameters included the intraoperative satisfaction score, the Visual Analog Scale (VAS) score, and the Oswestry Disability Index (ODI).
RESULTS


A total of 171 patients (61 men and 110 women; age range: 62-85 years) completed the full postoperative follow-up schedule, with 83 patients in the PKP + FJB group and 88 in the PKP group. No significant differences were observed in the genders, ages, preoperative bone mineral density, surgical levels, or volume of cement injected between the 2 groups (P > 0.05, respectively). The average duration of the surgeries in the PKP + FJB group was slightly longer than that in the PKP group (35.5 ± 4.8 min vs. 31.8 ± 4.3 min; P = 0.038), and in terms of the clinical outcomes, the average intraoperative satisfaction score was significantly higher in the PKP + FJB group (8.6 ± 1.1 vs. 6.3 ± 1.3; P < 0.001). Compared with the preoperative data, significant improvements in the VAS scores of back pain and ODI were observed at each follow-up interval (P < 0.05, respectively). These scores were significantly higher in the PKP + FJB group than in the PKP group; however, this was only observed within the first month after the procedure.
LIMITATIONS


A single-center noncontrol study.
CONCLUSIONS


The addition of an FJB (which in our study involved a unique combination of ropivacaine, prednisolone, and vitamin B12) improved the short-term clinical outcome of PKP for acute OVCFs. The local anti-inflammatory and analgesic effects on the facet joints resulted in higher intraoperative satisfaction and lower VAS and ODI scores for the first postoperative month when compared with the PKP group.",2021,The local anti-inflammatory and analgesic effects on the facet joints resulted in higher intraoperative satisfaction and lower VAS and ODI scores for the first postoperative month when compared with the PKP group.,"[""All data were from Honghui Hospital in Xi'an"", 'patients with acute OVCFs', '194 patients were eventually included in our study; they were randomly divided into 2 groups of 97 patients each and treated with either', '171 patients (61 men and 110 women; age range: 62-85 years) completed the full postoperative follow-up schedule, with 83 patients in the PKP + FJB group and 88 in the PKP group']","['FJB', 'PKP + FJB or PKP alone', 'Percutaneous kyphoplasty (PKP', 'PKP', 'PKP + FJB', 'ropivacaine, prednisolone, and vitamin B12', 'additional facet joint block (FJB']","['preoperative bone mineral density, surgical levels, or volume of cement injected', 'intraoperative satisfaction and lower VAS and ODI scores', 'VAS scores of back pain and ODI', 'average intraoperative satisfaction score', 'local anti-inflammatory and analgesic effects', 'pain relief', 'average duration of the surgeries', 'intraoperative satisfaction score, the Visual Analog Scale (VAS) score, and the Oswestry Disability Index (ODI']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0948248', 'cui_str': 'Facet joint block'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0948248', 'cui_str': 'Facet joint block'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",194.0,0.0510928,The local anti-inflammatory and analgesic effects on the facet joints resulted in higher intraoperative satisfaction and lower VAS and ODI scores for the first postoperative month when compared with the PKP group.,"[{'ForeName': 'Qing-Da', 'Initials': 'QD', 'LastName': 'Li', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Jun-Song', 'Initials': 'JS', 'LastName': 'Yang', 'Affiliation': ""Department of Spinal Surgery Hong-Hui Hospital Xi'an Jiaotong University.""}, {'ForeName': 'Han-Lin', 'Initials': 'HL', 'LastName': 'Gong', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, PR China.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Wei', 'Affiliation': 'Department of Spine Surgery, Baoji City Hospital of Traditional Chinese Medicine, Shaanxi, China.'}, {'ForeName': 'Xiang-Fu', 'Initials': 'XF', 'LastName': 'Wang', 'Affiliation': 'Department of Spinal Minimally Invasive Surgery, Gansu Provincial Hospital of Traditional Chinese Medicine, Gansu, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zou', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""No. 3201 Affiliated Hospital of Medical College of Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Ding-Jun', 'Initials': 'DJ', 'LastName': 'Hao', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Yuan-Ting', 'Initials': 'YT', 'LastName': 'Zhao', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chu', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China; Geriatric Clinical Research Center of Chongqing, Chongqing, China.'}]",Pain physician,[]
1248,34002953,Insulin resistance limits corneal nerve regeneration in patients with type 2 diabetes undergoing intensive glycemic control.,"AIMS/INTRODUCTION


This study aimed to investigate whether insulin resistance (IR) in individuals with type 2 diabetes undergoing intensive glycemic control determines the extent of improvement in neuropathy.
MATERIALS AND METHODS


This was an exploratory substudy of an open-label, randomized controlled trial of individuals with poorly controlled type 2 diabetes treated with exenatide and pioglitazone or insulin to achieve a glycated hemoglobin <7.0% (<53 mmol/mol). Baseline IR was defined using homeostasis model assessment of IR, and change in neuropathy was assessed using corneal confocal microscopy.
RESULTS


A total of 38 individuals with type 2 diabetes aged 50.2 ± 8.5 years with (n = 25, 66%) and without (n = 13, 34%) IR were studied. There was a significant decrease in glycated hemoglobin (P < 0.0001), diastolic blood pressure (P < 0.0001), total cholesterol (P < 0.01) and low-density lipoprotein (P = 0.05), and an increase in bodyweight (P < 0.0001) with treatment. Individuals with homeostasis model assessment of IR <1.9 showed a significant increase in corneal nerve fiber density (P ≤ 0.01), length (P ≤ 0.01) and branch density (P ≤ 0.01), whereas individuals with homeostasis model assessment of IR ≥1.9 showed no change. IR was negatively associated with change in corneal nerve fiber density after adjusting for change in bodyweight (P < 0.05).
CONCLUSIONS


Nerve regeneration might be limited in individuals with type 2 diabetes and IR undergoing treatment with pioglitazone plus exenatide or insulin to improve glycemic control.",2021,"Subjects with HOMA-IR <1.9 showed a significant increase in corneal nerve fiber density (CNFD) (P≤0.01), length (P≤0.01) and branch density (P≤0.01) whilst subjects with HOMA-IR ≥1.9 showed no change.","['patients with Type 2 diabetes undergoing intensive glycemic control', 'subjects with T2D undergoing intensive glycemic control', 'subjects with poorly controlled T2D treated with', 'or insulin to achieve an HbA1c <7.0% (<53 mmol/mol', 'Thirty-eight subjects with T2D aged 50.2 ± 8.5 years with (n=25, 66%) and without (n=13, 34%) IR were studied', 'subjects with T2D and IR undergoing treatment with']","['Insulin resistance limits corneal nerve regeneration', 'pioglitazone plus exenatide or insulin', 'insulin resistance (IR', 'exenatide and pioglitazone']","['body weight', 'diastolic blood pressure', 'glycemic control', 'HOMA-IR and change in neuropathy', 'total cholesterol (P<0.01) and LDL', 'corneal nerve fiber density (CNFD) (P≤0.01), length (P≤0.01) and branch density', 'HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027756', 'cui_str': 'Nerve Regeneration'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0027749', 'cui_str': 'Nerve fiber'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",38.0,0.0252152,"Subjects with HOMA-IR <1.9 showed a significant increase in corneal nerve fiber density (CNFD) (P≤0.01), length (P≤0.01) and branch density (P≤0.01) whilst subjects with HOMA-IR ≥1.9 showed no change.","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Ponirakis', 'Affiliation': 'Weill Cornell Medicine in Qatar, Qatar Foundation, Education City, Doha, Qatar.'}, {'ForeName': 'Muhammad A', 'Initials': 'MA', 'LastName': 'Abdul-Ghani', 'Affiliation': 'National Diabetes Center, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Jayyousi', 'Affiliation': 'National Diabetes Center, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'Zirie', 'Affiliation': 'National Diabetes Center, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Al-Mohannadi', 'Affiliation': 'Weill Cornell Medicine in Qatar, Qatar Foundation, Education City, Doha, Qatar.'}, {'ForeName': 'Hamad', 'Initials': 'H', 'LastName': 'Almuhannadi', 'Affiliation': 'Weill Cornell Medicine in Qatar, Qatar Foundation, Education City, Doha, Qatar.'}, {'ForeName': 'Ioannis N', 'Initials': 'IN', 'LastName': 'Petropoulos', 'Affiliation': 'Weill Cornell Medicine in Qatar, Qatar Foundation, Education City, Doha, Qatar.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Weill Cornell Medicine in Qatar, Qatar Foundation, Education City, Doha, Qatar.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Gad', 'Affiliation': 'Weill Cornell Medicine in Qatar, Qatar Foundation, Education City, Doha, Qatar.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Migahid', 'Affiliation': 'National Diabetes Center, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Megahed', 'Affiliation': 'National Diabetes Center, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Murtaza', 'Initials': 'M', 'LastName': 'Qazi', 'Affiliation': 'Weill Cornell Medicine in Qatar, Qatar Foundation, Education City, Doha, Qatar.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'AlMarri', 'Affiliation': 'Weill Cornell Medicine in Qatar, Qatar Foundation, Education City, Doha, Qatar.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Al-Khayat', 'Affiliation': 'Weill Cornell Medicine in Qatar, Qatar Foundation, Education City, Doha, Qatar.'}, {'ForeName': 'Ziyad', 'Initials': 'Z', 'LastName': 'Mahfoud', 'Affiliation': 'Weill Cornell Medicine in Qatar, Qatar Foundation, Education City, Doha, Qatar.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center, San Antonio, Texas, USA.'}, {'ForeName': 'Rayaz A', 'Initials': 'RA', 'LastName': 'Malik', 'Affiliation': 'Weill Cornell Medicine in Qatar, Qatar Foundation, Education City, Doha, Qatar.'}]",Journal of diabetes investigation,['10.1111/jdi.13582']
1249,34006565,Metformin Affects Gut Microbiome Composition and Function and Circulating Short-Chain Fatty Acids: A Randomized Trial.,"OBJECTIVE


To determine the longer-term effects of metformin treatment and behavioral weight loss on gut microbiota and short-chain fatty acids (SCFAs).
RESEARCH DESIGN AND METHODS


We conducted a 3-parallel-arm, randomized trial. We enrolled overweight/obese adults who had been treated for solid tumors but had no ongoing cancer treatment and randomized them ( n  = 121) to either  1 ) metformin (up to 2,000 mg),  2 ) coach-directed behavioral weight loss, or  3 ) self-directed care (control) for 12 months. We collected stool and serum at baseline ( n  = 114), 6 months ( n  = 109), and 12 months ( n  = 105). From stool, we extracted microbial DNA and conducted amplicon and metagenomic sequencing. We measured SCFAs and other biochemical parameters from fasting serum.
RESULTS


Of the 121 participants, 79% were female and 46% were Black, and the mean age was 60 years. Only metformin treatment significantly altered microbiota composition. Compared with control, metformin treatment increased amplicon sequence variants for  Escherichia  (confirmed as  Escherichia coli  by metagenomic sequencing) and  Ruminococcus torques  and decreased  Intestinibacter bartlettii  at both 6 and 12 months and decreased the genus  Roseburia , including  R. faecis  and  R. intestinalis,  at 12 months. Effects were similar in comparison of the metformin group with the behavioral weight loss group. Metformin versus control also increased butyrate, acetate, and valerate at 6 months (but not at 12 months). Behavioral weight loss versus control did not significantly alter microbiota composition but did increase acetate at 6 months (but not at 12 months). Increases in acetate were associated with decreases in fasting insulin. Additional whole-genome metagenomic sequencing of a subset of the metformin group showed that metformin altered 62 metagenomic functional pathways, including an acetate-producing pathway and three pathways in glucose metabolism.
CONCLUSIONS


Metformin, but not behavioral weight loss, impacted gut microbiota composition at 6 months and 12 months. Both metformin and behavioral weight loss altered circulating SCFAs at 6 months, including increasing acetate, which correlated with lower fasting insulin. Future research is needed to elucidate whether the gut microboime mediates or modifies metformin's health effects.",2021,"Compared with control, metformin treatment increased amplicon sequence variants for  Escherichia  (confirmed as  Escherichia coli  by metagenomic sequencing) and  Ruminococcus torques  and decreased  Intestinibacter bartlettii  at both 6 and 12 months and decreased the genus  Roseburia , including  R. faecis  and  R. intestinalis,  at 12 months.","['enrolled overweight/obese adults who had been treated for solid tumors but had no ongoing cancer treatment and randomized them ( n  = 121) to either', 'Of the 121 participants, 79% were female and 46% were Black, and the mean age was 60 years']","['2 ) coach-directed behavioral weight loss, or  3 ) self-directed care (control', 'metformin', 'Metformin', '1 ) metformin', 'control, metformin']","['fasting insulin', 'Behavioral weight loss', 'Gut Microbiome Composition and Function and Circulating Short-Chain Fatty Acids', 'butyrate, acetate, and valerate', 'gut microbiota and short-chain fatty acids (SCFAs', 'microbiota composition', 'behavioral weight loss, impacted gut microbiota composition', 'altered microbiota composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0042280', 'cui_str': 'Pentanoates'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",79.0,0.0444262,"Compared with control, metformin treatment increased amplicon sequence variants for  Escherichia  (confirmed as  Escherichia coli  by metagenomic sequencing) and  Ruminococcus torques  and decreased  Intestinibacter bartlettii  at both 6 and 12 months and decreased the genus  Roseburia , including  R. faecis  and  R. intestinalis,  at 12 months.","[{'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Mueller', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD noeltmueller@jhu.edu.'}, {'ForeName': 'Moira K', 'Initials': 'MK', 'LastName': 'Differding', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Nisa M', 'Initials': 'NM', 'LastName': 'Maruthur', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD.'}]",Diabetes care,['10.2337/dc20-2257']
1250,34013542,"Analgesic efficacy of a portable, disposable, and self-applied transcutaneous electrical nerve stimulation device during migraine attacks: A real-life randomized controlled trial.","OBJECTIVE


The objective of this study was to evaluate the analgesic efficacy of a portable, disposable, and home self-applied transcutaneous electrical nerve stimulation (TENS) device during migraine attacks.
BACKGROUND


TENS has been used as a noninvasive treatment for migraine, but there are no reports on the outcomes following use of this treatment option for use at home during migraine attacks.
DESIGN AND METHODS


A double-blind, randomized controlled trial was conducted over 3 months, with monthly assessments. Active placebos (sham group) were in place and were allocated at a 1:1 ratio. Adult patients who had been diagnosed with migraine by a specialist were included. Pain intensity levels and functional disability were measured before and after the 20-min self-applied TENS intervention during the migraine attacks.
RESULTS


Seventy-four participants were randomly allocated to the sham and intervention groups. Although both groups of subjects reported lower pain scores, the intervention group showed a statistically significant reduction in pain scores compared to the sham group.
CONCLUSION


In our controlled trial, the use of a self-applied, TENS device is safe and effective in relieving pain associated with migraine attacks. Participants in the intervention group showed a statistically significant improvement in pain and functional disability scores. TENS has been used as a noninvasive treatment for migraine, but there are no reports on the outcomes following use of this treatment option for use at home during migraine attacks. This double-blind, randomized controlled trial had 2 groups: active-placebo and intervention. Seventy-four participants were randomly allocated. Participants in the intervention group showed a statistically significant improvement in pain and functional disability scores.",2021,"Although both groups of subjects reported lower pain scores, the intervention group showed a statistically significant reduction in pain scores compared to the sham group.
","['Seventy-four participants', 'migraine attacks', 'Adult patients who had been diagnosed with migraine by a specialist were included']","['transcutaneous electrical nerve stimulation intervention', 'Active placebos', 'portable, disposable, and self-applied transcutaneous electrical nerve stimulation device', 'portable, disposable and home self-applied transcutaneous electrical nerve stimulation device', 'transcutaneous electrical nerve stimulation device']","['analgesic efficacy', 'pain and functional disability scores', 'lower pain scores', 'Pain intensity levels and functional disability', 'Analgesic efficacy', 'pain scores']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",74.0,0.120243,"Although both groups of subjects reported lower pain scores, the intervention group showed a statistically significant reduction in pain scores compared to the sham group.
","[{'ForeName': 'Flávia S', 'Initials': 'FS', 'LastName': 'Domingues', 'Affiliation': 'Surgical Specialties and Anesthesiology Department, Medical School, Sao Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Maisa V', 'Initials': 'MV', 'LastName': 'Gayoso', 'Affiliation': 'Surgical Specialties and Anesthesiology Department, Medical School, Sao Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Shafaq', 'Initials': 'S', 'LastName': 'Sikandar', 'Affiliation': 'Barts and The London School of Medicine & Dentistry, William Harvey Research Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Leopoldo Muniz', 'Initials': 'LM', 'LastName': 'da Silva', 'Affiliation': ""Anesthesiology Department (CMA), São Luiz Hospital, Rede D'or, São Paulo, Brazil.""}, {'ForeName': 'Ronaldo G', 'Initials': 'RG', 'LastName': 'Fonseca', 'Affiliation': 'Neurology Department, Medical School, Sao Paulo State University (UNESP, Botucatu, Brazil.'}, {'ForeName': 'Guilherme A M', 'Initials': 'GAM', 'LastName': 'de Barros', 'Affiliation': 'Surgical Specialties and Anesthesiology Department, Medical School, Sao Paulo State University (UNESP), Botucatu, Brazil.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.13042']
1251,34016610,Response to Comment on Neeland et al. The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care 2020;43:3007-3015.,,2021,,[],['Empagliflozin'],['Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes'],[],"[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0912167,,"[{'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Neeland', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University Hospitals Harrington Heart and Vascular Institute and Case Western Reserve University School of Medicine, Cleveland, OH ian.neeland@uhhospitals.org.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Wojeck', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Henry K', 'Initials': 'HK', 'LastName': 'Yaggi', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dci21-0009']
1252,34021020,"Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial.","OBJECTIVE


To evaluate the efficacy of aluminum-formulated intralymphatic glutamic acid decarboxylase (GAD-alum) therapy combined with vitamin D supplementation in preserving endogenous insulin secretion in all patients with type 1 diabetes (T1D) or in a genetically prespecified subgroup.
RESEARCH DESIGN AND METHODS


In a multicenter, randomized, placebo-controlled, double-blind trial, 109 patients aged 12-24 years (mean ± SD 16.4 ± 4.1) with a diabetes duration of 7-193 days (88.8 ± 51.4), elevated serum GAD65 autoantibodies, and a fasting serum C-peptide >0.12 nmol/L were recruited. Participants were randomized to receive either three intralymphatic injections (1 month apart) with 4 μg GAD-alum and oral vitamin D (2,000 IE daily for 120 days) or placebo. The primary outcome was the change in stimulated serum C-peptide (mean area under the curve [AUC] after a mixed-meal tolerance test) between baseline and 15 months.
RESULTS


Primary end point was not met in the full analysis set (treatment effect ratio 1.091 [CI 0.845-1.408];  P  = 0.5009). However, GAD-alum-treated patients carrying HLA DR3-DQ2 ( n  = 29; defined as DRB1*03, DQB1*02:01) showed greater preservation of C-peptide AUC (treatment effect ratio 1.557 [CI 1.126-2.153];  P  = 0.0078) after 15 months compared with individuals receiving placebo with the same genotype ( n  = 17). Several secondary end points showed supporting trends, and a positive effect was seen in partial remission (insulin dose-adjusted HbA 1c  ≤9;  P  = 0.0310). Minor transient injection site reactions were reported.
CONCLUSION


Intralymphatic administration of GAD-alum is a simple, well-tolerated treatment that together with vitamin D supplementation seems to preserve C-peptide in patients with recent-onset T1D carrying HLA DR3-DQ2. This constitutes a disease-modifying treatment for T1D with a precision medicine approach.",2021,"RESULTS


Primary end point was not met in the full analysis set (treatment effect ratio 1.091 [CI 0.845-1.408];  P  = 0.5009).","['all patients with type 1 diabetes (T1D) or in a genetically prespecified subgroup', '109 patients aged 12-24 years (mean ± SD 16.4 ± 4.1) with a diabetes duration of 7-193 days (88.8 ± 51.4), elevated serum GAD65 autoantibodies, and a fasting serum C-peptide >0.12 nmol/L were recruited', 'Recent-Onset Type 1 Diabetes']","['vitamin D supplementation', 'Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation', 'aluminum-formulated intralymphatic glutamic acid decarboxylase (GAD-alum) therapy combined with vitamin D supplementation', 'Placebo', 'intralymphatic injections (1 month apart) with 4 μg GAD-alum and oral vitamin D', 'placebo']","['change in stimulated serum C-peptide (mean area under the curve [AUC', 'partial remission ', 'preservation of C-peptide AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1512956', 'cui_str': 'Intralymphatic route'}, {'cui': 'C0017785', 'cui_str': 'Glutamate decarboxylase'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021491', 'cui_str': 'Intralymphatic Injections'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]",109.0,0.77935,"RESULTS


Primary end point was not met in the full analysis set (treatment effect ratio 1.091 [CI 0.845-1.408];  P  = 0.5009).","[{'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Ludvigsson', 'Affiliation': ""Division of Pediatrics, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences and Crown Princess Victoria Children's Hospital, Linköping University, Linköping, Sweden johnny.ludvigsson@liu.se.""}, {'ForeName': 'Zdenek', 'Initials': 'Z', 'LastName': 'Sumnik', 'Affiliation': 'Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Terezie', 'Initials': 'T', 'LastName': 'Pelikanova', 'Affiliation': 'Diabetes Centre of the Institute of Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Nattero Chavez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Lundberg', 'Affiliation': 'Institution of Clinical Science, Department of Pediatrics, Umeå University, Norrland University Hospital, Umeå, Sweden.'}, {'ForeName': 'Itxaso', 'Initials': 'I', 'LastName': 'Rica', 'Affiliation': 'Department of Pediatric Endocrinology, Cruces University Hospital, CIBERDEM, Bilbao, Spain.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Martínez-Brocca', 'Affiliation': 'Department of Endocrinology, Virgen Macarena Hospital, Sevilla, Spain.'}, {'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Ruiz de Adana', 'Affiliation': 'Department of Adult Endocrinology and Diabetology, General University Hospital, Instituto de Biomedicina de Málaga, CIBERDEM, Malaga, Spain.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Wahlberg', 'Affiliation': 'Departments of Endocrinology Region Östergötland and Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Katsarou', 'Affiliation': 'Department of Endocrinology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Ragnar', 'Initials': 'R', 'LastName': 'Hanas', 'Affiliation': 'Department of Pediatrics, NU Hospital Group, Uddevalla, Sweden.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hernandez', 'Affiliation': ""Department of Endocrinology and Nutrition, Vall d'Hebron Hospital, CIBERDEM, Barcelona, Spain.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Clemente León', 'Affiliation': ""Department of Endocrinology and Nutrition, Vall d'Hebron Hospital, CIBERDEM, Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gómez-Gila', 'Affiliation': 'Pediatric Endocrinology Service, Virgen del Rocío University Hospital, Sevilla, Spain.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Marta Ferrer', 'Initials': 'MF', 'LastName': 'Lozano', 'Affiliation': 'Department of Pediatric Endocrinology, Miguel Servet University Hospital, Zaragoza, Spain.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Sas', 'Affiliation': 'Diabeter, National Treatment and Research Center for Children, Adolescents and Young Adults With Type 1 Diabetes, and Department of Pediatric Endocrinology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Samuelsson', 'Affiliation': ""Division of Pediatrics, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences and Crown Princess Victoria Children's Hospital, Linköping University, Linköping, Sweden.""}, {'ForeName': 'Stepanka', 'Initials': 'S', 'LastName': 'Pruhova', 'Affiliation': 'Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Fabricia', 'Initials': 'F', 'LastName': 'Dietrich', 'Affiliation': 'Division of Pediatrics, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Puente Marin', 'Affiliation': 'Division of Pediatrics, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Nordlund', 'Affiliation': 'Trial Form Support, Lund, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Hannelius', 'Affiliation': 'Diamyd Medical AB, Stockholm, Sweden.'}, {'ForeName': 'Rosaura', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': 'Division of Pediatrics, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.'}]",Diabetes care,['10.2337/dc21-0318']
1253,34028926,Brain imaging of cannabinoid type I (CB 1  ) receptors in women with cannabis use disorder and male and female healthy controls.,"Cannabis effects are predominantly mediated by pharmacological actions on cannabinoid type 1 (CB 1  ) receptors. Prior positron emission tomography (PET) studies in individuals who use cannabis included almost exclusively males. PET studies in females are needed because there are sex differences in cannabis effects, progression to cannabis use disorder (CUD), and withdrawal symptom severity. Females with CUD (N = 10) completed two double-blind cannabis smoking sessions (Session 1: placebo; Session 2: active), and acute cannabis effects were assessed. After Session 2, participants underwent 3 days of monitored cannabis abstinence; mood, craving, and withdrawal symptoms were assessed and a PET scan (radiotracer: [ 11  C]OMAR) followed. [ 11  C]OMAR Distribution volume (V T  ) from these participants was compared with V T  of age/BMI-similar female non-users of cannabis (""healthy controls""; N = 10). V T  was also compared between female and male healthy controls (N = 7). Females with CUD displayed significantly lower V T  than female healthy controls in specific brain regions (hippocampus, amygdala, cingulate, and insula). Amygdala V T  was negatively correlated with mood changes (anger/hostility) during abstinence, but V T  was not correlated with other withdrawal symptoms or cannabis effects. Among healthy controls, females had significantly higher V T  than males in all brain regions examined. Chronic cannabis use appears to foster downregulation of CB 1  receptors in women, as observed previously in men, and there are inherent sex differences in CB 1  availability. Future studies should elucidate the time course of CB 1  downregulation among females who use cannabis and examine the relation between CB 1  availability and cannabis effects among other populations (e.g., infrequent users; medicinal users).",2021,"Females with CUD displayed significantly lower V T  than female healthy controls in specific brain regions (hippocampus, amygdala, cingulate, and insula).","['Females with CUD (N\u2009=\u200910) completed two', 'women with cannabis use disorder and male and female healthy controls', 'individuals who use cannabis included almost exclusively males']","['Prior positron emission tomography (PET', 'cannabinoid type I (CB 1  ) receptors', 'double-blind cannabis smoking sessions (Session 1: placebo']","['craving, and withdrawal symptoms', 'mood changes (anger/hostility', 'withdrawal symptoms or cannabis effects']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0342788', 'cui_str': 'Renal carnitine transport defect'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0006873', 'cui_str': 'Cannabis Smoking'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0182612,"Females with CUD displayed significantly lower V T  than female healthy controls in specific brain regions (hippocampus, amygdala, cingulate, and insula).","[{'ForeName': 'Tory R', 'Initials': 'TR', 'LastName': 'Spindle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Kuwabara', 'Affiliation': 'Division of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Alisha', 'Initials': 'A', 'LastName': 'Eversole', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Ayon', 'Initials': 'A', 'LastName': 'Nandi', 'Affiliation': 'Division of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Denis G', 'Initials': 'DG', 'LastName': 'Antoine', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Umbricht', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Guarda', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Dean F', 'Initials': 'DF', 'LastName': 'Wong', 'Affiliation': 'Division of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Weerts', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}]",Addiction biology,['10.1111/adb.13061']
1254,34024814,"Short foot exercises have additional effects on knee pain, foot biomechanics, and lower extremity muscle strength in patients with patellofemoral pain.","BACKGROUND


Patellofemoral pain (PFP) is a common knee problem. The foot posture in a relaxed stance is reported as a distal factor of PFP. However, the effects of short foot exercise (SFE) on the knee and functional factors have not yet been investigated in patients with PFP.
OBJECTIVE


This study aimed to investigate the additional effects of SFE on knee pain, foot biomechanics, and lower extremity muscle strength in patients with PFP following a standard exercise program.
METHODS


Thirty patients with a 'weak and pronated' foot subgroup of PFP were randomized into a control group (ConG, n= 15) and a short foot exercise group (SFEG, n= 15) with concealed allocation and blinded to the group assignment. The program of ConG consisted of hip and knee strengthening and stretching exercises. SFEG program consisted of additional SFE. Both groups performed the supervised training protocol two times per week for 6 weeks. Assessment measures were pain visual analog scale (pVAS), Kujala Patellofemoral Score (KPS), navicular drop test (NDT), rearfoot angle (RA), foot posture index (FPI), and strength tests of the lower extremity muscles.
RESULTS


Both groups displayed decreases in pVAS scores, but it was only significant in favor of SFEG. NDT, RA, and FPI scores decreased in SFEG whereas they increased in ConG. There was a significant group-by-time interaction effect in hip extensor strength and between-group difference was found to be significantly in favor of SFEG.
CONCLUSIONS


An intervention program consisting of additional SFE had positive effects on knee pain, navicular position, and rearfoot posture. An increase in the strength of the hip extensors may also be associated with improved stabilization by SFE.",2021,"There was a significant group-by-time interaction effect in hip extensor strength and between-group difference was found to be significantly in favor of SFEG.
","['patients with patellofemoral pain', ""Thirty patients with a 'weak and pronated' foot subgroup of PFP"", 'patients with PFP following a standard exercise program', 'patients with PFP']","['hip and knee strengthening and stretching exercises', 'control group (ConG, n= 15) and a short foot exercise group (SFEG, n= 15) with concealed allocation', 'SFE', 'short foot exercise (SFE']","['pain visual analog scale (pVAS), Kujala Patellofemoral Score (KPS), navicular drop test (NDT), rearfoot angle (RA), foot posture index (FPI), and strength tests of the lower extremity muscles', 'pVAS scores', 'hip extensor strength', 'knee pain, foot biomechanics, and lower extremity muscle strength', 'strength of the hip extensors', 'knee pain, navicular position, and rearfoot posture', 'NDT, RA, and FPI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0576226', 'cui_str': 'Short foot'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0223947', 'cui_str': 'Bone structure of navicular'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",30.0,0.0125072,"There was a significant group-by-time interaction effect in hip extensor strength and between-group difference was found to be significantly in favor of SFEG.
","[{'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Kısacık', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Volga Bayrakcı', 'Initials': 'VB', 'LastName': 'Tunay', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Nilgün', 'Initials': 'N', 'LastName': 'Bek', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Lokman Hekim University, Ankara, Turkey.'}, {'ForeName': 'Özgür Ahmet', 'Initials': 'ÖA', 'LastName': 'Atay', 'Affiliation': 'Department of Orthopedics and Traumatology, Faculty of Medicine, Hacettepe University Ankara, Ankara, Turkey.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Selfe', 'Affiliation': 'Department of Health Professions, Faculty of Health, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Aynur Ayşe', 'Initials': 'AA', 'LastName': 'Karaduman', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Lokman Hekim University, Ankara, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200255']
1255,34024813,A comparison of the effects of static stretching and the fascial distortion model (FDM) on hamstring flexibility.,"BACKGROUND


Hamstring flexibility plays a significant role in physiotherapy. Various stretching studies have been conducted to increase hamstring flexibility, but the effects of the Fascial Distortion Model (FDM) on hamstring flexibility have not yet been investigated. Moreover, no studies have compared the effects of FDM and static stretching.
OBJECTIVES


To investigate the effects of the FDM on hamstring flexibility compared with static stretching.
METHODS


Thirthy healthy adults were divided into two groups: static stretching and FDM groups. Static stretching was performed to hamstring in the supine position. The FDM was performed using trigger band techniques that followed the hamstring in a longitudinal direction. Hamstring flexibility was measured using the active knee extension angle (KEA), passive straight leg raising (SLR), sit-and-reach (SR), and finger-floor distance (FFD) tests. A paired t-test and an independent t-test were performed to compare the hamstring flexibility measurements.
RESULTS


Both groups showed significant differences (p< 0.05) in KEA, SLR, SR, and FFD before and after. However, no significant difference (p> 0.05) was found between the two groups.
CONCLUSIONS


There was no difference in the effects of FDM and static stretching on hamstring flexibility.",2021,"Both groups showed significant differences (p< 0.05) in KEA, SLR, SR, and FFD before and after.",['Thirthy healthy adults'],"['static stretching and the Fascial Distortion Model', 'FDM', 'static stretching and FDM', 'FDM and static stretching', 'static stretching', 'Static stretching']","['KEA, SLR, SR, and FFD', 'hamstring flexibility', 'active knee extension angle (KEA), passive straight leg raising (SLR), sit-and-reach (SR), and finger-floor distance (FFD) tests', 'hamstring flexibility measurements', 'Hamstring flexibility']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0235591,"Both groups showed significant differences (p< 0.05) in KEA, SLR, SR, and FFD before and after.","[{'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Masan University, Changwon, Korea.'}, {'ForeName': 'Seong Yoel', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Kyungnam University, Changwon, Korea.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200219']
1256,34024812,The immediate effect of sustained natural apophyseal glide on postural stability and pain in individuals presenting with flexion-dominant chronic low back pain: A randomized single-blinded placebo-controlled trial.,"BACKGROUND


Low back pain (LBP) is a common musculoskeletal problem, which commonly affects balance. Sustained natural apophyseal glide (SNAG) is a successful treatment approach for LPB. However, its influence on balance problems has not been studied before.
OBJECTIVE


To investigate the immediate effect of SNAG on postural stability and pain in individuals with flexion-dominant chronic low back pain (FCLBP).
METHODS


Randomized placebo-controlled trial in which 64 participants with FCLBP were randomly allocated into two groups (SNAG and sham). SNAG group (n= 32) received central lumbar SNAG on the symptomatic lumbar level(s). Sham group (n= 32) received sham SNAG. The outcome measures were postural stability indices; overall stability index (OSI), anteroposterior stability index (APSI), and mediolateral stability index (MLSI) in addition to pain intensity. Outcomes were assessed using the Biodex Balance System and visual analog scale respectively. Measures were taken before and immediately after interventions.
RESULTS


There were statistical significance and high effect size (ES) in favor of the SNAG group regarding OSI, APSI, and pain (p< 0.01, cohen's d ES =1.3, 1.4, 1.1 respectively). MLSI showed moderate ES (cohen's d= 0.7) but did not reach a statistically significant level (p= 0.05).
CONCLUSION


Lumbar SNAG produces an immediate improvement in postural stability and pain in individuals with FCLBP.",2021,"There were statistical significance and high effect size (ES) in favor of the SNAG group regarding OSI, APSI, and pain (p> 0.01, cohen's d ES =1.3, 1.4, 1.1 respectively).","['individuals with flexion-dominant chronic low back pain (FCLBP', 'subjects with FCLBP', '64 participants with FCLBP', 'individuals presenting with flexion-dominant chronic low back pain']","['central lumbar SNAG', 'Lumbar SNAG', 'sustained natural apophyseal glide', 'Sustained natural apophyseal glide (SNAG', 'placebo', 'SNAG', 'sham SNAG']","['Biodex Balance System and visual analog scale respectively', 'OSI, APSI, and pain', 'postural stability indices; overall stability index (OSI), anteroposterior stability index (APSI), and mediolateral stability index (MLSI) in addition to pain intensity', 'postural stability and pain', 'moderate ES']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",64.0,0.350992,"There were statistical significance and high effect size (ES) in favor of the SNAG group regarding OSI, APSI, and pain (p> 0.01, cohen's d ES =1.3, 1.4, 1.1 respectively).","[{'ForeName': 'Hisham Mohamed', 'Initials': 'HM', 'LastName': 'Hussein', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Amal Ahmed', 'Initials': 'AA', 'LastName': 'Morsi', 'Affiliation': 'Basic Science Department, Misr University for Science and Technology, Giza, Egypt.'}, {'ForeName': 'Neveen Abdellatif', 'Initials': 'NA', 'LastName': 'Abdelraoof', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200217']
1257,34024025,Effects of Gocovri (Amantadine) Extended-Release Capsules on Motor Aspects of Experiences of Daily Living in People with Parkinson's Disease and Dyskinesia.,"INTRODUCTION


Gocovri, a bedtime-administered delayed-release/extended-release capsule formulation of amantadine, is the only drug approved by the US Food and Drug Administration as levodopa-adjunctive therapy for the treatment of OFF episodes and/or dyskinesia in Parkinson's disease (PD). Part II of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assesses patient-perceived disability on experiences of daily living affected by PD motor symptoms. We analyzed Gocovri-related changes in MDS-UPDRS Part II ratings in two placebo-controlled clinical trials.
METHODS


Baseline to week 12 changes in MDS-UPDRS Part II total and item scores were compared for Gocovri and placebo using pooled data from phase 3 trials (EASE LID and EASE LID 3).
RESULTS


Baseline mean MDS-UPDRS Part II total score was 15.1 for Gocovri (n = 100) and 15.3 for placebo (n = 96) groups. At week 12, the least squares mean change from baseline was -3.4 for the Gocovri group and -1.4 for placebo (treatment difference, -2.0; 95% CI -3.3 to -0.7; P = 0.004). For Gocovri, change from baseline exceeded a published minimal clinically important difference threshold of 3.05. Gocovri-related treatment differences over placebo were driven primarily by improvement in the scale items of freezing (-0.4; P < 0.0001), tremor (-0.4; P = 0.002), getting out of bed/car/deep chair (-0.3; P = 0.002), and eating tasks (-0.2; P = 0.016).
CONCLUSION


In addition to improvement in dyskinesia, Gocovri-treated participants experienced improvement in motor aspects of experiences of daily living. Analyses suggest that Gocovri may specifically improve freezing, tremor, getting out of bed/car/deep chair, and eating tasks.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT02136914, NCT02274766.",2021,Baseline mean MDS-UPDRS Part II total score was 15.1 for Gocovri (n = 100) and 15.3 for placebo (n = 96) groups.,"[""OFF episodes and/or dyskinesia in Parkinson's disease (PD"", ""Experiences of Daily Living in People with Parkinson's Disease and Dyskinesia""]","['amantadine', 'Gocovri (Amantadine', 'Gocovri and placebo', 'placebo', 'levodopa-adjunctive therapy']","['motor aspects of experiences of daily living', 'MDS-UPDRS', 'getting out of bed/car/deep chair', 'freezing, tremor, getting out of bed/car/deep chair, and eating tasks', 'Baseline mean MDS-UPDRS Part II total score', 'eating tasks']","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C4522700', 'cui_str': 'Gocovri'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.350984,Baseline mean MDS-UPDRS Part II total score was 15.1 for Gocovri (n = 100) and 15.3 for placebo (n = 96) groups.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': ""USF Parkinson's Disease and Movement Disorders Center, Parkinson Foundation Center of Excellence, University of South Florida, 4001 E. Fletcher Ave, 6th Floor, Tampa, FL, 33613, USA. rhauser@usf.edu.""}, {'ForeName': 'Shyamal H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Department of Neurology, Mayo Clinic-Scottsdale, Scottsdale, AZ, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kremens', 'Affiliation': 'Department of Neurology, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Chernick', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Formella', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.'}]",Neurology and therapy,['10.1007/s40120-021-00256-1']
1258,34042408,Effects of position-triggered electrical stimulation on poststroke hemiparetic shoulder subluxation.,"BACKGROUND


Shoulder subluxation is a frequent complication after stroke causing joint instability, shoulder pain, decreased activities of daily living, and impedance to rehabilitation progress. Electrical stimulation (ES) is considered an effective modality to reduce shoulder subluxation in acute stroke. However, few studies have investigated the effect of position-triggered ES, which induces active muscle contraction though accurate motion detection.
AIM


The aim of this study was to investigate whether position-triggered ES was more effective in reducing acute hemiplegic shoulder subluxation after stroke than passive ES.
DESIGN


Single-blind, randomized controlled trial.
SETTING


The study setting was the university hospital rehabilitation center.
POPULATION


Fifty poststroke subacute hemiparetic patients with shoulder subluxation.
METHODS


Patients were randomly assigned into two groups. The position-triggered ES group received 30-minute ES sessions, 5 days per week for 3 weeks with specially modified Novastim ®  CU-FS1 (CU Medical Systems, Inc., Gangwon-do, South Korea) for motion triggering. The passive ES group received the same protocol without motion triggering. The vertical distance (VD) and the joint distance (JD), relative VD and JD (rVD, rJD), upper extremity component of Fugl-Meyer Motor Assessment (FMA<inf>upper</inf>), Motricity Index (MI), Manual Function Test (MFT), and peak torque of affected shoulder abductor (PT) were assessed at baseline (T0), end of electrical stimulation session (T1), and 3 weeks (T2) after treatment.
RESULTS


Repeated-measures analysis of variance revealed significant interaction between time and intervention on JD and rJD, indicating that shoulder subluxation was significantly more reduced in position-triggered ES than in passive ES (P<0.05). However, FMA<inf>upper</inf>, MI, MFT, and PT did not show this significance. The change of (∆)JD, ∆rVD, and ∆rJD in the motion-triggered ES group improved significantly more at T1 than in the passive ES group (P<0.05). This significant improvement was not seen at T2.
CONCLUSIONS


Position-triggered ES may be more effective than passive ES in improving poststroke shoulder subluxation; however, this effect was not maintained after the withdrawal of stimulation.
CLINICAL REHABILITATION IMPACT


Position-triggered ES may be useful to reducing poststroke shoulder subluxation.",2021,"AIM


To investigate whether position-triggered ES was more effective in reducing acute hemiplegic shoulder subluxation after stroke than passive ES.
","['Fifty post-stroke subacute hemiparetic patients with shoulder subluxation', 'post-stroke hemiparetic shoulder subluxation', 'Patients', 'University hospital rehabilitation center']","['position-triggered ES', 'Electrical stimulation (ES', 'position-triggered electrical stimulation']","['shoulder subluxation', 'position-triggered ES', 'vertical distance (VD) and the joint distance (JD), relative VD and JD (rVD, rJD), upper extremity component of Fugl-Meyer Motor Assessment (FMAupper), Motricity Index (MI), Manual Function Test (MFT), and peak torque of affected shoulder abductor (PT', 'change of (Δ)JD , ΔrVD, and ΔrJD']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0434744', 'cui_str': 'Subluxation of shoulder joint'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0434744', 'cui_str': 'Subluxation of shoulder joint'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451322', 'cui_str': 'Motricity index'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.040225,"AIM


To investigate whether position-triggered ES was more effective in reducing acute hemiplegic shoulder subluxation after stroke than passive ES.
","[{'ForeName': 'Juntaek', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Department of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Taemin', 'Initials': 'T', 'LastName': 'Jung', 'Affiliation': 'Yonsei ROI Rehabilitation Clinic, Seoul, South Korea.'}, {'ForeName': 'Aeryoung', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Hyoseon', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Department of Rehabilitation Medicine, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sunmi', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Deogyoung', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, South Korea - kimdy@yuhs.ac.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.21.06639-9']
1259,34045031,Effectiveness of Cardiac Telerehabilitation With Relapse Prevention: SmartCare-CAD Randomized Controlled Trial.,,2021,,[],['Cardiac Telerehabilitation'],[],[],"[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}]",[],,0.326842,,"[{'ForeName': 'Rutger W M', 'Initials': 'RWM', 'LastName': 'Brouwers', 'Affiliation': ''}, {'ForeName': 'Jos J', 'Initials': 'JJ', 'LastName': 'Kraal', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Regis', 'Affiliation': ''}, {'ForeName': 'Ruud F', 'Initials': 'RF', 'LastName': 'Spee', 'Affiliation': ''}, {'ForeName': 'Hareld M C', 'Initials': 'HMC', 'LastName': 'Kemps', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.03.328']
1260,34045018,"Effects of Diet and Sodium Reduction on Cardiac Injury, Strain, and Inflammation: The DASH-Sodium Trial.","BACKGROUND


The DASH (Dietary Approaches to Stop Hypertension) diet has been determined to have beneficial effects on cardiac biomarkers. The effects of sodium reduction on cardiac biomarkers, alone or combined with the DASH diet, are unknown.
OBJECTIVES


The purpose of this study was to determine the effects of sodium reduction and the DASH diet, alone or combined, on biomarkers of cardiac injury, strain, and inflammation.
METHODS


DASH-Sodium was a controlled feeding study in adults with systolic blood pressure (BP) 120 to 159 mm Hg and diastolic BP 80 to 95 mm Hg, randomly assigned to the DASH diet or a control diet. On their assigned diet, participants consumed each of three sodium levels for 4 weeks. Body weight was kept constant. At the 2,100 kcal level, the 3 sodium levels were low (50 mmol/day), medium (100 mmol/day), and high (150 mmol/day). Outcomes were 3 cardiac biomarkers: high-sensitivity cardiac troponin I (hs-cTnI) (measure of cardiac injury), N-terminal pro-B-type natriuretic peptide (NT-proBNP) (measure of strain), and high-sensitivity C-reactive protein (hs-CRP) (measure of inflammation), collected at baseline and at the end of each feeding period.
RESULTS


Of the original 412 participants, the mean age was 48 years; 56% were women, and 56% were Black. Mean baseline systolic/diastolic BP was 135/86 mm Hg. DASH (vs. control) reduced hs-cTnI by 18% (95% confidence interval [CI]: -27% to -7%) and hs-CRP by 13% (95% CI: -24% to -1%), but not NT-proBNP. In contrast, lowering sodium from high to low levels reduced NT-proBNP independently of diet (19%; 95% CI: -24% to -14%), but did not alter hs-cTnI and mildly increased hs-CRP (9%; 95% CI: 0.4% to 18%). Combining DASH with sodium reduction lowered hs-cTnI by 20% (95% CI: -31% to -7%) and NT-proBNP by 23% (95% CI: -32% to -12%), whereas hs-CRP was not significantly changed (-7%; 95% CI: -22% to 9%) compared with the high sodium-control diet.
CONCLUSIONS


Combining a DASH dietary pattern with sodium reduction can lower 2 distinct mechanisms of subclinical cardiac damage: injury and strain, whereas DASH alone reduced inflammation. (Dietary Patterns, Sodium Intake and Blood Pressure [DASH - Sodium]; NCT00000608).",2021,DASH (vs. control) reduced hs-cTnI by 18% (95% confidence interval [CI]: -27,"['412 participants', 'mean age was 48 years; 56% were women, and 56% were Black', 'adults with systolic blood pressure (BP) 120 to 159']","['Diet and Sodium Reduction', 'DASH diet or a control diet']","['hs-cTnI and mildly increased hs-CRP', 'Body weight', 'Hg and diastolic BP', 'hs-CRP', 'Dietary Patterns, Sodium Intake and Blood Pressure', 'cardiac biomarkers: high-sensitivity cardiac troponin', 'sodium reduction lowered hs-cTnI', 'NT-proBNP', 'Cardiac Injury, Strain, and Inflammation', 'Mean baseline systolic/diastolic BP']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",412.0,0.120297,DASH (vs. control) reduced hs-cTnI by 18% (95% confidence interval [CI]: -27,"[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: sjurasch@bidmc.harvard.edu.'}, {'ForeName': 'Lara C', 'Initials': 'LC', 'LastName': 'Kovell', 'Affiliation': 'Division of Cardiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': ""Harvard T.H. Chan School of Public Health, Harvard Medical School, Brigham & Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Geisinger Health, Danville, Pennsylvania, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Christenson', 'Affiliation': 'Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rebuck', 'Affiliation': 'Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.03.320']
1261,34029565,A Pilot Randomized Trial of Transdermal Nicotine for Pulmonary Sarcoidosis.,"BACKGROUND


Tobacco smoking is associated with a reduced risk of developing sarcoidosis, and we previously reported that nicotine normalizes immune responses to environmental antigens in patients with active pulmonary sarcoidosis. The effects of nicotine on the progression of pulmonary sarcoidosis are unknown.
RESEARCH QUESTION


Is nicotine treatment well tolerated, and will it improve lung function in patients with active pulmonary sarcoidosis?
STUDY DESIGN AND METHODS


With local institutional review board approval, a randomized, double-blind, controlled pilot trial was conducted of daily nicotine transdermal patch treatment (21 mg daily) or placebo patch use for 24 weeks. The Ohio State University Wexner Medical Center and Cleveland Clinic enrolled 50 consecutive subjects aged ≥ 18 years with active pulmonary sarcoidosis, based on symptoms (ie, dyspnea, cough) and objective radiographic evidence of infiltrates consistent with nonfibrotic lung disease. Each study group was compared at 26 weeks based on repeated measures of FVC, FEV 1 , quantitative lung texture score based on CT texture analysis, Fatigue Assessment Score (FAS), St. George's Respiratory Questionnaire (SGRQ), and the Sarcoidosis Assessment Tool.
RESULTS


Nicotine treatment was associated with a clinically significant, approximately 2.1% (70 mL) improvement in FVC from baseline to 26 weeks. FVC decreased by a similar amount (2.2%) in the placebo group, with a net increase of 140 mL (95% CI, 10-260) when comparing nicotine vs placebo groups at 26 weeks. FEV 1  and FAS improved marginally in the nicotine-treated group, compared with those on placebo. No improvement was observed in lung texture score, FAS, St. George's Respiratory Questionnaire score, or the Sarcoidosis Assessment Tool. There were no reported serious adverse events or evidence of nicotine addiction.
INTERPRETATION


Nicotine treatment was well tolerated in patients with active pulmonary sarcoidosis, and the preliminary findings of this pilot study suggest that it may reduce disease progression, based on FVC.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov; No.: NCT02265874; URL: www.clinicaltrials.gov.",2021,"RESULTS


Nicotine treatment was associated with a clinically significant, approximately 2.1% (70 ml), improvement in FVC from baseline to 26 weeks.","['Pulmonary Sarcoidosis', 'With local IRB approval', 'patients with active pulmonary sarcoidosis', 'The Ohio State University Wexner Medical Center and Cleveland Clinic enrolled 50 consecutive adult subjects 18 years of age and older with active pulmonary sarcoidosis, based on symptoms (dyspnea, cough) and objective radiographic evidence of infiltrates consistent with non-fibrotic lung disease']","['Transdermal Nicotine', 'placebo patch', 'nicotine', 'placebo', 'daily nicotine transdermal patch treatment']","['pulmonary sarcoidosis progression', 'FVC', 'improvement in FVC', 'FEV1 and FAS', 'forced vital capacity (FVC), forced expiratory volume in one second (FEV1), quantitative lung texture score (LTS) based on CT texture analysis, Fatigue Assessment Score (FAS), St George Respiratory Questionnaire (SGRQ), Sarcoidosis Assessment Tool (SAT', 'LTS, FAS, SGRQ or SAT']","[{'cui': 'C0036205', 'cui_str': 'Pulmonary sarcoidosis'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036205', 'cui_str': 'Pulmonary sarcoidosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036202', 'cui_str': 'Sarcoidosis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",50.0,0.348048,"RESULTS


Nicotine treatment was associated with a clinically significant, approximately 2.1% (70 ml), improvement in FVC from baseline to 26 weeks.","[{'ForeName': 'Elliott D', 'Initials': 'ED', 'LastName': 'Crouser', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, The Ohio State University, Columbus, OH. Electronic address: Elliott.Crouser@osumc.edu.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Smith', 'Affiliation': 'Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Culver', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Julian', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Baran', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Diaz', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH.'}, {'ForeName': 'Barbaros Selnur', 'Initials': 'BS', 'LastName': 'Erdal', 'Affiliation': 'Department of Radiology, Mayo Clinic Hospital, Jacksonville, FL.'}, {'ForeName': 'Erinn M', 'Initials': 'EM', 'LastName': 'Hade', 'Affiliation': 'Division of Biostatistics, Department of Population Health, New York University Grossman School of Medicine, New York, NY.'}]",Chest,['10.1016/j.chest.2021.05.031']
1262,33999260,The clinical efficacy of novel vacuum suction ureteroscopic lithotripsy in the treatment of upper ureteral calculi.,"OBJECTIVE


To investigate the clinical efficacy of a novel vacuum suction ureteroscopic approach in the treatment of upper ureteral calculi and to compare it with traditional rigid and flexible ureteroscopic approaches.
SUBJECTS AND METHODS


A total of 160 patients with impacted upper ureteral calculi were included in this study. 50 patients underwent rigid ureteroscopic lithotripsy, 54 patients underwent flexible ureteroscopic lithotripsy, and 56 patients underwent vacuum suction ureteroscopic lithotripsy. The operative time, length of hospitalization, stone-free rate, the incidence of postoperative complications, and total treatment cost were compared among the three groups. Subgroup analysis was performed based on the stone diameter over and below 1.5 cm.
RESULTS


All operations were performed successfully, and there were no cases converted to open surgery. Compared with the other 2 groups, the vacuum suction ureteroscopy group had a higher stone-free rate at 3-5 days (90.0% vs. 61.9% vs. 55.6%, P < 0.05) and 1 month (96.4% vs. 77.7% vs. 74.0%, P < 0.05) postoperatively. In subgroup analysis, the stone-free rate of the vacuum suction ureteroscopy group was significantly higher when the stone diameter was > 1.5 cm at 1 month postoperatively (P < 0.05) compared with that in the other 2 groups; however, there were no differences in postoperative complications. (P > 0.05).
CONCLUSION


The novel vacuum suction ureteroscopic lithotripsy has significantly improved the stone-free rate especially in complicated cases, compared with that in rigid and flexible approaches; however, the complication and cost were not increased.",2021,"The novel vacuum suction ureteroscopic lithotripsy has significantly improved the stone-free rate especially in complicated cases, compared with that in rigid and flexible approaches; however, the complication and cost were not increased.","['upper ureteral calculi', '50 patients underwent', '160 patients with impacted upper ureteral calculi']","['novel vacuum suction ureteroscopic approach', 'vacuum suction ureteroscopy', 'rigid ureteroscopic lithotripsy', 'vacuum suction ureteroscopic lithotripsy', 'novel vacuum suction ureteroscopic lithotripsy', 'flexible ureteroscopic lithotripsy']","['stone-free rate', 'stone diameter', 'postoperative complications', 'complication and cost', 'operative time, length of hospitalization, stone-free rate, the incidence of postoperative complications, and total treatment cost']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}]",160.0,0.0446086,"The novel vacuum suction ureteroscopic lithotripsy has significantly improved the stone-free rate especially in complicated cases, compared with that in rigid and flexible approaches; however, the complication and cost were not increased.","[{'ForeName': 'Lv Wen', 'Initials': 'LW', 'LastName': 'Zhang', 'Affiliation': 'Urology Division, Sheng Jing Hospital, China Medical University, Shenyang, 110000, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Fei', 'Affiliation': 'Urology Division, Sheng Jing Hospital, China Medical University, Shenyang, 110000, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Urology Division, Sheng Jing Hospital, China Medical University, Shenyang, 110000, China. Alexander-song@163.com.'}]",World journal of urology,['10.1007/s00345-021-03722-5']
1263,34002820,Treatment options after regorafenib failure in metastatic colorectal cancer.,"OBJECTIVE


In the treatment of metastatic colorectal cancer (mCRC), there is a need for a treatment option in patients who have received regorafenib (RGR) therapy and progressed, especially in patients fit enough to receive a new therapy. We aimed to compare the role of rechallenge chemotherapy (RCH CTx) with best supportive care (BSC) in mCRC patients after standard CTx and subsequent RGR treatment in terms of survival benefit.
PATIENTS AND METHODS


Patients with progressive mCRC who received at least one month of subsequent RGR therapy after standard CTx treatments were included in the study. Patients were divided into two groups: receiving RCH CTx or BSC (without antitumoural therapy) after RGR failure. There were 26 patients in the RCH CTx group and 30 patients in the BSC group. The RCH CTx and BSC groups were compared for demographic and clinical features, laboratory parameters, and survival rates.
RESULTS


After the RGR failure, the median overall survival (OS) for the RCH CTx (n = 26) and BSC (n = 30) groups were 7.5 (95% CI, 6.3-8.7) months and 1.2 (95% CI, 0.9-1.5) months, respectively (p < 0.001). The median OS was 7.5 (95% CI, 6.3-8.7) months for the RCH CTx (n = 26) and 1.4 (95% CI, 0.3-2.4) months for the BSC (n = 14) groups when only the patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 at progression with RGR treatment were compared, respectively (p < 0.001).
CONCLUSIONS


After the RGR failure, mCRC patients, especially those with a better ECOG-PS (≤ 2) and adequate organ function, should be considered candidates for RCH CTx instead of BSC.",2021,"The median OS was 7.5 (95% CI, 6.3-8.7) months for the RCH CTx (n = 26) and 1.4 (95% CI, 0.3-2.4) months for the BSC (n = 14) groups when only the patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 at progression with RGR treatment were compared, respectively (p < 0.001).
","['mCRC patients after', 'metastatic colorectal cancer', 'Patients with progressive mCRC who received at least one month of subsequent RGR therapy after standard CTx treatments were included in the study', '26 patients in the RCH CTx group and 30 patients in the BSC group', 'metastatic colorectal cancer (mCRC', 'patients who have received']","['RCH CTx or BSC (without antitumoural therapy', 'standard CTx and subsequent RGR treatment', 'rechallenge chemotherapy (RCH CTx', 'regorafenib (RGR) therapy']","['median overall survival (OS', 'median OS', 'survival rates']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.108518,"The median OS was 7.5 (95% CI, 6.3-8.7) months for the RCH CTx (n = 26) and 1.4 (95% CI, 0.3-2.4) months for the BSC (n = 14) groups when only the patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 at progression with RGR treatment were compared, respectively (p < 0.001).
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Eraslan', 'Affiliation': 'Medical Oncology, University of Health Sciences Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Ankara, Turkey. dremraheraslan@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Doğan', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Yildiz', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'İlhan', 'Affiliation': ''}, {'ForeName': 'Ö B', 'Initials': 'ÖB', 'LastName': 'Öksüzoğlu', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202105_25828']
1264,33999691,"Association of a Lay Health Worker-Led Intervention on Goals of Care, Quality of Life, and Clinical Trial Participation Among Low-Income and Minority Adults With Cancer.","PURPOSE


New approaches are needed to overcome low supportive care and clinical trial participation among low-income and minority adults with cancer. The objective of this project was to determine whether a lay health worker intervention was associated with improvements in supportive care and trial participation.
METHODS


We conducted a quality improvement initiative in collaboration with a union organization. We enrolled union members newly diagnosed with cancer into a 6-month lay health worker-led intervention from October 15, 2016, to February 28, 2017. The primary outcome was goals of care. Secondary outcomes were health-related quality of life (HRQOL), health care use, and trial participation. All outcomes except HRQOL were compared with a cohort of union members diagnosed within the 6-month preintervention period.
RESULTS


Sixty-six adults participated in the intervention group, and we identified 72 adults in the control group. Demographic characteristics were similar between groups. The mean age was 56.0 years; 47 (34%) were male, and 22 were White (16%). Within 6 months enrollment, more intervention group participants, as compared with the control, had clinician-documented goals of care (94%  v  26%;  P  < .001) and participated in cancer clinical trials (72%  v  22%;  P  < .001). At 4 months postenrollment, as compared with baseline, intervention participants experienced HRQOL improvements (mean difference, 3.98 points; standard deviation, 2.83;  P  < .001). Before death, more intervention group participants used palliative care and hospice than the control group.
CONCLUSION


Lay health worker-led interventions may improve supportive care and clinical trial participation among low-income and minority populations with cancer.",2021,"Within 6 months enrollment, more intervention group participants, as compared with the control, had clinician-documented goals of care (94%  v  26%;  P  < .001) and participated in cancer clinical trials (72%  v  22%;  P  < .001).","['enrolled union members newly diagnosed with cancer into a 6-month lay health worker-led intervention from October 15, 2016, to February 28, 2017', 'minority adults with cancer', 'The mean age was 56.0 years; 47 (34%) were male, and 22 were White (16', 'Low-Income and Minority Adults With Cancer', 'Sixty-six adults participated in the intervention group, and we identified 72 adults in the control group']","['lay health worker intervention', 'Lay Health Worker-Led Intervention']","['health-related quality of life (HRQOL), health care use, and trial participation', 'clinician-documented goals of care', 'goals of care', 'HRQOL improvements', 'Demographic characteristics', 'palliative care and hospice', 'Goals of Care, Quality of Life']","[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}]",66.0,0.164825,"Within 6 months enrollment, more intervention group participants, as compared with the control, had clinician-documented goals of care (94%  v  26%;  P  < .001) and participated in cancer clinical trials (72%  v  22%;  P  < .001).","[{'ForeName': 'Manali I', 'Initials': 'MI', 'LastName': 'Patel', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Khateeb', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Tumaini', 'Initials': 'T', 'LastName': 'Coker', 'Affiliation': ""Seattle Children's Research Institute, Seattle, WA.""}]",JCO oncology practice,['10.1200/OP.21.00100']
1265,34010788,Five-year changes in ovarian function restoration in premenopausal patients with breast cancer taking tamoxifen after chemotherapy: An ASTRRA study report.,"BACKGROUND


Adding ovarian function suppression (OFS) after chemotherapy improves survival in young women with moderate- and high-risk breast cancer. Assessment of ovarian function restoration after chemotherapy becomes critical for subsequent endocrine treatment and addressing fertility issues.
PATIENTS AND METHODS


In the adding OFS after chemotherapy trial, patients who resumed ovarian function up to 2 years after chemotherapy were randomised to receive either 5 years of tamoxifen or adding 2 years of OFS with tamoxifen. Ovarian function was evaluated from enrolment to randomisation, and patients who did not randomise because of amenorrhoea for 2 years received tamoxifen and were followed up for 5 years. Prospectively collected consecutive hormone levels (proportion of patients with premenopausal follicle-stimulating hormone [FSH] levels <30 mIU/mL and oestradiol [E2] levels ≥40 pg/mL) and history of menstruation were available for 1067 patients with breast cancer.
RESULTS


Over 5 years of tamoxifen treatment, 69% of patients resumed menstruation and 98% and 74% of patients satisfied predefined ovarian function restoration as per serum FSH and E2 levels, respectively. Menstruation was restored in 91% of patients younger than 35 years at baseline, but in only 33% of 45-year-old patients over 5 years. Among these patients, 41% experienced menstruation restoration within 2 years after chemotherapy and 28% slowly restored menstruation after 2-5 years. Younger age (<35 years) at baseline, anthracycline without taxanes and ≤90 days of chemotherapy were predictors of menstruation restoration.
CONCLUSIONS


During 5 years of tamoxifen treatment after chemotherapy, two-thirds of the patients experienced menstruation restoration, especially patients younger than 35 years. Young age, Adriamycin without taxanes and short duration of chemotherapy appeared to have a positive effect on ovarian reserves in the long term.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00912548.",2021,"Menstruation was restored in 91% of patients younger than 35 years at baseline, but in only 33% of 45-year-old patients over 5 years.","['premenopausal patients with breast cancer taking', 'Younger age (<35 years) at baseline, anthracycline without taxanes and ≤90 days of chemotherapy were predictors of menstruation restoration', 'patients who did not randomise because of amenorrhoea for 2 years received', 'young women with moderate- and high-risk breast cancer', 'patients with premenopausal follicle-stimulating hormone [FSH] levels\xa0<30 mIU/mL\xa0and oestradiol [E2] levels\xa0≥40\xa0pg/mL) and history of menstruation were available for 1067 patients with breast cancer', 'patients who resumed ovarian function up to 2 years after chemotherapy']","['ovarian function suppression (OFS', 'tamoxifen', 'Adriamycin without taxanes', 'OFS with tamoxifen', 'chemotherapy']","['ovarian function restoration', 'Menstruation', 'Ovarian function', 'survival', 'ovarian function restoration as per serum FSH and E2 levels', 'menstruation restoration']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0455276', 'cui_str': 'Serum follicle stimulating hormone measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1067.0,0.102471,"Menstruation was restored in 91% of patients younger than 35 years at baseline, but in only 33% of 45-year-old patients over 5 years.","[{'ForeName': 'Hee J', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Republic of Korea.'}, {'ForeName': 'Woo C', 'Initials': 'WC', 'LastName': 'Noh', 'Affiliation': 'Department of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Republic of Korea.'}, {'ForeName': 'Seok J', 'Initials': 'SJ', 'LastName': 'Nam', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Byeong-Woo', 'Initials': 'BW', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun S', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Center for Breast Cancer, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Seock A', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong S', 'Initials': 'YS', 'LastName': 'Jung', 'Affiliation': 'Department of Surgery, Ajou University, School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Jung H', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Sung S', 'Initials': 'SS', 'LastName': 'Kang', 'Affiliation': ""Department of Surgery, Cheil General Hospital and Women's Healthcare Center, Dankook University College of Medicine, Seoul, Republic of Korea.""}, {'ForeName': 'Kyong H', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Soo-Jung', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Yeungnam University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, Gangnam Severance Hospital, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Min H', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, SoonChunHyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Se H', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Sung Y', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, SoonChunHyang University College of Medicine, Cheonan Hospital, Cheonan, Republic of Korea.'}, {'ForeName': 'Hyun-Ah', 'Initials': 'HA', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Republic of Korea.'}, {'ForeName': 'Se-Hwan', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Ajou University, School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Wonshik', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Min H', 'Initials': 'MH', 'LastName': 'Hur', 'Affiliation': 'Department of Surgery, Inha University Hospital, Inha University School of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Seonok', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Epidemiology and Biostatics, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Sei H', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Republic of Korea. Electronic address: ahnsh@amc.seoul.kr.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.03.017']
1266,34023318,"Personalized Variable vs Fixed-Dose Systemic Corticosteroid Therapy in Hospitalized Patients With Acute Exacerbations of COPD: A Prospective, Multicenter, Randomized, Open-Label Clinical Trial.","BACKGROUND


Systemic corticosteroids for the treatment of COPD exacerbations decrease treatment failure and shorten the length of hospitalization. However, the optimal dose is unclear.
RESEARCH QUESTION


Is personalized-dose corticosteroid administered according to a dosing scale more effective than fixed-dose corticosteroid administration in hospitalized patients with COPD with exacerbations?
STUDY DESIGN AND METHODS


This was a prospective, randomized, open-label trial. In-hospital patients with COPD with exacerbations were randomly assigned at a 1:1 ratio to either the fixed-dose group (receiving the equivalent of 40 mg of prednisolone) or the personalized-dose group for 5 days. The primary end point was a composite measure of treatment failure that included in-hospital treatment failure and medium-term (postdischarge) failure. Secondary end points were length of stay and cost.
RESULTS


A total of 248 patients were randomly assigned to the fixed-dose group (n = 124) or personalized-dose group (n = 124). One patient in each group was not included in the intention-to-treat population because of incorrect initial COPD diagnosis. Failure of therapy occurred in 27.6% in the personalized-dose group, compared with 48.8% in the fixed-dose group (relative risk, 0.40; 95% CI, 0.24-0.68; P = .001). The in-hospital failure of therapy was significantly lower in the personalized-dose group (10.6% vs 24.4%; P = .005), whereas the medium-term failure rate, adverse event rate, hospital length of stay, and costs were similar between the two groups. After treatment failure, a lower additional dose of corticosteroids and a shorter duration of treatment were needed in the personalized-dose group to achieve control of the exacerbation. In the personalized-dose cohort, those receiving 40 mg or less had an average failure rate of 44.4%, compared with 22.9% among those receiving more than 40 mg (P = .027).
INTERPRETATION


Personalized dosing of corticosteroids reduces the risk of failure because more patients were provided with a higher initial dose, especially > 60 mg, whereas 40 mg or less was too low in either group.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov; No.: NCT02147015; URL: www.clinicaltrials.gov.",2021,"Failure of therapy occurred in 27.6% in the personalised-dose group, compared to 48.8% in the fixed-dose group (RR 0.40, 95% CI 0.24-0.68, p = 0.001).","['248 patients', 'hospitalized COPD patients with exacerbations', 'In-hospital COPD patients with exacerbations', 'Hospitalized Patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease']","['Personalised Variable vs Fixed Dose Systemic Corticosteroid Therapy', 'prednisolone equivalent) or personalised-dose group for 5 days', 'corticosteroids']","['composite measure of treatment failure that included in-hospital treatment failure and medium-term (post-discharge) failure', 'length of stay and cost', 'average failure rate', 'Failure of therapy', 'medium-term failure rate, adverse event rate, hospital length of stay and costs', 'hospital failure of therapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",248.0,0.157885,"Failure of therapy occurred in 27.6% in the personalised-dose group, compared to 48.8% in the fixed-dose group (RR 0.40, 95% CI 0.24-0.68, p = 0.001).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology, College of Preventive Medicine, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Fenfen', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Binfeng', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Institute of Respiratory Diseases, Xinqiao Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': ""Chongqing Ninth People's Hospital, Chongqing, China.""}, {'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China; Department of Respiratory Medicine, Third Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xingsheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Chongqing Emergency Medical Center, Central Hospital Affiliated to Chongqing University, Chongqing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Shisi', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Naifu', 'Initials': 'N', 'LastName': 'Nie', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Wen', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Guangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jones', 'Affiliation': ""Institute for Infection and Immunity, St. George's, University of London, London, United Kingdom.""}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China. Electronic address: cgq1963@163.com.'}]",Chest,['10.1016/j.chest.2021.05.024']
1267,34028828,Cost-effectiveness analysis of atraumatic restorative treatment to manage early childhood caries: microsimulation modelling.,"BACKGROUND


This study assessed the cost-effectiveness of atraumatic restorative treatment and the Hall Technique approach (ART/HT) in managing dental caries in young children under the health provider perspective in order to explore a best-buy alternative to dental general anaesthesia (DGA).
METHODS


Sixty-five observations from a randomized controlled trial were used to construct 20 000 microsimulations representing individual-level clinical outcome and costs of the DGA and ART/HT. Outcome was percentage of successfully managed cases. Costs were reported in 2020 price. Three different scenarios with different assumptions of clinical success of the DGA and the ART/HT were analysed. Probabilistic sensitivity analysis was carried out.
RESULTS


The ART/HT successfully managed more cases at lower cost ($557) than the DGA when the system failure of the DGA was considered. Under per protocol analysis, participants in both arms were successfully managed, but the ART/HT costed $580 less than the DGA. Probabilistic sensitivity analysis confirmed the ART/HT was a dominant intervention.
CONCLUSIONS


The ART/HT approach was non-inferior in managing dental caries in young children but at lower costs than the DGA. The ART/HT could be a viable option in the provision of comprehensive dental care in locations with limited access to DGA and reduce hospital admission.",2021,The ART/HT could be a viable option in the provision of comprehensive dental care in locations with limited access to DGA and reduce hospital admission.,"['young children', 'Sixty-five observations', 'manage early-childhood caries']","['Atraumatic Restorative Treatment and the Hall Technique approach (ART/HT', 'atraumatic restorative treatment']",[],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]",[],65.0,0.149131,The ART/HT could be a viable option in the provision of comprehensive dental care in locations with limited access to DGA and reduce hospital admission.,"[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Tonmukayakul', 'Affiliation': 'Deakin Health Economics, Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Forrest', 'Affiliation': 'Dental Health Services, Bentley Delivery Centre, Perth, Western Australia, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Arrow', 'Affiliation': 'Dental Health Services, Bentley Delivery Centre, Perth, Western Australia, Australia.'}]",Australian dental journal,['10.1111/adj.12857']
1268,34029555,Extracorporeal Shockwave Therapy in the Treatment of Trigger Finger: A Randomized Controlled Study.,"OBJECTIVES


To determine the efficacy of extracorporeal shockwave therapy (ESWT) and to determine the ideal energy flux density of wide-focused ESWT in the treatment of trigger finger (TF).
DESIGN


Double-blind randomized controlled trial.
SETTING


A university hospital.
PARTICIPANTS


A total of 60 patients (N=60) with grade II TF according to the Quinnell classification were randomly and evenly allocated to 3 treatment groups.
INTERVENTIONS


Three treatment groups included a high-energy ESWT (HS) group (energy flux density of 0.01 mJ/mm 2 , 5.8 bar, 1500 impulses, once per week for 4wk), a low-energy ESWT (LS) group (energy flux density of 0.006 mJ/mm 2 , 3 bar, 1500 impulses, once per week for 4wk), and a sham intervention group (sham group). All participants received 6 months of follow-up after intervention when only painkillers were allowed as concomitant treatment.
MAIN OUTCOME MEASURES


Clinical outcomes were followed at baseline and 1, 3, and 6 months after intervention, including pain score, frequency of triggering, severity of triggering, functional impact of triggering, and quick Disabilities of the Arm, Shoulder, and Hand questionnaire (qDASH).
RESULTS


All groups showed significant improvements from baseline in all clinical parameters, except for functional impact of triggering, 6 months after the interventions. However, the HS group demonstrated a higher magnitude of improvement than the LS and sham groups. In addition, the HS group reported significantly lower pain (P=.01) and lower qDASH (P=.008) than the sham group 6 months after the interventions. No adverse effects were reported in the HS and LS groups within 6 months of follow-up.
CONCLUSIONS


Wide-focused ESWT is a safe and effective but dose-dependent alternative facilitating pain relief and functional improvement in the treatment of grade II TF according to the Quinnell classification.",2021,"In addition, the HS group reported significantly lower pain (p = .01) and lower qDASH (p = .008) than the sham group at the sixth month following interventions.","['A university hospital PARTICIPANTS', 'trigger finger', '60 patients with grade II TF according to the Quinnell classification']","['low-energy ESWT (LS) group ', 'extracorporeal shock wave therapy (ESWT', 'Wide-focused ESWT', 'Extracorporeal shock wave therapy', 'high-energy ESWT (HS']","['lower qDASH', 'pain score, frequency of triggering (FT), severity of triggering (ST), functional impact of triggering (FIT), and quick Disabilities of the Arm, Shoulder, and Hand (qDASH) questionnaire', 'adverse effects', 'lower pain']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0158328', 'cui_str': 'Trigger finger'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.116961,"In addition, the HS group reported significantly lower pain (p = .01) and lower qDASH (p = .008) than the sham group at the sixth month following interventions.","[{'ForeName': 'Yu-Pin', 'Initials': 'YP', 'LastName': 'Chen', 'Affiliation': 'Institute of Clinical Medicine, National Yang-Ming University, Taipei; Institute of Clinical Medicine, National Yang Ming Chiao Tung University, Taipei; Department of Orthopedic Surgery, Wan Fang Hospital, Taipei Medical University, Taipei; Department of Orthopedic Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Institute of Allied Health Sciences, College of Medicine, National Cheng Kung University, Tainan.'}, {'ForeName': 'Yi-Jie', 'Initials': 'YJ', 'LastName': 'Kuo', 'Affiliation': 'Department of Orthopedic Surgery, Wan Fang Hospital, Taipei Medical University, Taipei; Department of Orthopedic Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei.'}, {'ForeName': 'Oscar Kuang-Sheng', 'Initials': 'OK', 'LastName': 'Lee', 'Affiliation': 'Institute of Clinical Medicine, National Yang-Ming University, Taipei; Institute of Clinical Medicine, National Yang Ming Chiao Tung University, Taipei; Department of Medical Research, Taipei Veterans General Hospital, Taipei; Department of Orthopedics, China Medical University Hospital, Taichung, Taiwan. Electronic address: oscarlee9203@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.04.015']
1269,34036689,Psychiatric nurse delivered group-cognitive-behavioral therapy for internalizing behavior problems among children of parents with alcohol use disorders.,"PURPOSE


The present study aimed at assessing the effectiveness of group-cognitive-behavioral therapy for anxiety, depression, and self-esteem among children of parents with alcohol use disorder.
DESIGN AND METHODS


A randomized, controlled trial study was conducted with 70 children of parents with alcohol use disorder. The children were initially screened for the presence of behavioral problems and living with parents with alcohol use disorder, then assigned randomly to experimental and control groups. The experimental group received eight biweekly group CBT sessions.
RESULTS


Over 3-month study period, the results showed a statistically significant reduction in depression and anxiety scores and a significant improvement in self-esteem scores among CBT group children compared with the control group children.
CONCLUSION


Our study demonstrates the effectiveness of CBT group treatment for children of parents with an alcohol use disorder and that school mental health nurses/psychiatric nurses can effectively deliver psychotherapy for behavioral and emotional problems of high-risk children.",2021,"Over 3-month study period, the results showed a statistically significant reduction in depression and anxiety scores and a significant improvement in self-esteem scores among CBT group children compared with the control group children.
","['children of parents with alcohol use disorder', 'children were initially screened for the presence of behavioral problems and living with parents with alcohol use disorder', 'children of parents with an alcohol use disorder and that school mental health nurses/psychiatric nurses', 'high-risk children', '70 children of parents with alcohol use disorder', 'children of parents with alcohol use disorders']","['CBT', 'group-cognitive-behavioral therapy', 'psychotherapy', 'Psychiatric nurse delivered group-cognitive-behavioral therapy']","['anxiety, depression, and self-esteem', 'depression and anxiety scores', 'self-esteem scores']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0557133', 'cui_str': 'Lives with parents'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.00548844,"Over 3-month study period, the results showed a statistically significant reduction in depression and anxiety scores and a significant improvement in self-esteem scores among CBT group children compared with the control group children.
","[{'ForeName': 'Dayananda B', 'Initials': 'DB', 'LastName': 'Omkarappa', 'Affiliation': 'Department of Psychiatric Nursing, Kempegowda College of Nursing, Bangalore, Karnataka, India.'}, {'ForeName': 'Sreevani', 'Initials': 'S', 'LastName': 'Rentala', 'Affiliation': 'Department of Psychiatric Nursing, Dharwad Institute of Mental health and Neuroscience, Dharwad, Karnataka, India.'}, {'ForeName': 'Prasanthi', 'Initials': 'P', 'LastName': 'Nattala', 'Affiliation': 'Department of Nursing, National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore, Karnataka, India.'}]","Journal of child and adolescent psychiatric nursing : official publication of the Association of Child and Adolescent Psychiatric Nurses, Inc",['10.1111/jcap.12329']
1270,34034202,Improving urinary tract infection treatment through a multifaceted antimicrobial stewardship intervention in the emergency department.,"BACKGROUND


Urinary tract infection (UTI) is frequently encountered in the emergency department (ED). We assessed an antibiotic stewardship intervention tailored for the ED. The primary objective was improving overall adherence to agent choice and treatment duration. The secondary objective was a decrease in fluoroquinolone prescription.
METHODS


This pre-post study included patients discharged from the ED with a UTI diagnosis. The intensive intervention period lasted three months and involved dissemination of guidelines, short lectures, incorporation of order sets into electronic ED charts and weekly personal audit and feedback. The following 11-month phase was a booster period consisting of monthly text messages of the treatment protocol. Assessment of adherence to the protocol was compared between the three-month pre-intervention period and the last two months of the intensive intervention period, as well as with the last two months of the booster period.
RESULTS


A total of 177 patients were included in the pre-intervention period, 156 in the intervention period, and 94 in the late follow-up assessing the booster period. Median age was 49 (18-94) years, 78.2% were female, 84.8% had cystitis. During the intervention period, protocol adherence with antibiotic selection and duration increased from 41% to 84% (p < 0.001). Adherence remained high in the late follow-up period (73.4% vs. 41%, p < 0.001). Fluoroquinolone use decreased from 19.1% pre-intervention, to 5% in the intervention and 7.4% in the late follow-up periods (p < 0.001).
CONCLUSIONS


An antibiotic stewardship intervention in a busy ED resulted in adherence to treatment protocols, including a decrease in fluoroquinolone use. A monthly reminder preserved most of the effect for a year.",2021,"Adherence remained high in the late follow-up period (73.4% vs. 41%, p < 0.001).","['A total of 177 patients were included in the pre-intervention period, 156 in the intervention period, and 94 in the late follow-up assessing the booster period', 'patients discharged from the ED with a UTI diagnosis', 'Median age was 49 (18-94) years, 78.2% were female, 84.8% had cystitis']","['Fluoroquinolone', 'antibiotic stewardship intervention', 'multifaceted antimicrobial stewardship intervention']","['fluoroquinolone prescription', 'Adherence', 'overall adherence to agent choice and treatment duration']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0647859', 'cui_str': 'AM 49'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}]","[{'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]",177.0,0.0148184,"Adherence remained high in the late follow-up period (73.4% vs. 41%, p < 0.001).","[{'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Zalmanovich', 'Affiliation': 'Infectious Diseases Unit, Meir Medical Center, Kfar Saba, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Katzir', 'Affiliation': 'Infectious Diseases Unit, Meir Medical Center, Kfar Saba, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Chowers', 'Affiliation': 'Infectious Diseases Unit, Meir Medical Center, Kfar Saba, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Aridge', 'Initials': 'A', 'LastName': 'Matar', 'Affiliation': 'Clinical Pharmacy Services, Meir Medical Center, Kfar Saba, Israel.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rodrig', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; Emergency Department, Meir Medical Center, Kfar Saba, Israel.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Alon', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; Internal Medicine A, Meir Medical Center, Kfar Saba, Israel. Electronic address: alond1@clalit.org.il.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.05.037']
1271,34032900,"Postprandial muscle protein synthesis rate is unaffected by 20-day habituation to a high protein intake: a randomized controlled, crossover trial.","PURPOSE


During the last decade more researchers have argued in favor of an increased protein intake for older adults. However, there is a lack of knowledge on the long-term effects of conforming to such a high protein intake with regards to the basal and postprandial muscle protein turnover. The purpose of this study was to compare the postprandial synthesis response in muscle proteins, and the abundance of directly incorporated food-derived amino acids following habituation to high vs. recommended level of protein intake.
METHODS


In a double blinded crossover intervention 11 older male participants (66.6 ± 1.7 years of age) were habituated for 20 days to a recommended protein (RP) intake (1.1 g protein/kg lean body mass (LBM)/day) and a high protein (HP) intake (> 2.1 g protein/kg LBM/day). Following each habituation period, intrinsically labelled proteins were ingested as part of a mixed meal to determine the incorporation of meal protein-derived amino acids into myofibrillar proteins. Furthermore, the myofibrillar fractional synthesis rate (FSR) and amino acid kinetics across the leg were determined using gold standard stable isotope tracer methodologies. RT qPCR was used to assess the expression of markers related to muscle proteinsynthesis and breakdown.
RESULTS


No impact of habituation was observed on skeletal muscle amino acid or protein kinetics. However, the shunting of amino acids directly from artery to vein was on average 2.9 [Formula: see text]mol/min higher following habituation to HP compared to RP.
CONCLUSIONS


In older males, habituation to a higher than the currently recommended protein intake did not demonstrate any adaptions in the muscle protein turnover or markers hereof when subjected to an intake of an identical mixed meal.
CLINICAL TRIAL REGISTRY


Journal number NCT02587156, Clinicaltrials.org. Date of registration: October 27th, 2015.",2021,"In older males, habituation to a higher than the currently recommended protein intake did not demonstrate any adaptions in the muscle protein turnover or markers hereof when subjected to an intake of an identical mixed meal.
","['older adults', '11 older male participants (66.6\u2009±\u20091.7\xa0years of age']",['RT qPCR'],"['postprandial synthesis response', 'myofibrillar fractional synthesis rate (FSR) and amino acid kinetics', 'skeletal muscle amino acid or protein kinetics', 'Postprandial muscle protein synthesis rate']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}]",11.0,0.0745017,"In older males, habituation to a higher than the currently recommended protein intake did not demonstrate any adaptions in the muscle protein turnover or markers hereof when subjected to an intake of an identical mixed meal.
","[{'ForeName': 'Grith', 'Initials': 'G', 'LastName': 'Højfeldt', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark. grithwh@gmail.com.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bülow', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Agergaard', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.'}, {'ForeName': 'Lene R', 'Initials': 'LR', 'LastName': 'Simonsen', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bülow', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schjerling', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holm', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.'}]",European journal of nutrition,['10.1007/s00394-021-02590-4']
1272,34037821,"Acute consumption of a shake containing cashew and Brazil nuts did not affect appetite in overweight subjects: a randomized, cross-over study.","PURPOSE


Evidence from epidemiological and clinical studies suggests that nut consumption provides satiety and may contribute to the management of obesity. However, the effect of acute intake of nuts on appetite responses remains unclear. The objective of this study was to evaluate the acute effect of a shake containing 30 g of cashew nuts (Anacardium occidentale L.) and 15 g of Brazil nuts (Bertholletia excelsa H.B.K) on appetite responses in overweight subjects.
METHODS


This was a clinical, randomized, controlled, single-blind, cross-over, pilot study. On two non-consecutive test days, 15 subjects received a shake containing nuts, and a shake absent of nuts matched for energy and macronutrient content. Subjective appetite sensation was evaluated by visual analogue scales (VAS). Food intake was measured by weighing the lunch served at the end of each morning-test, which subjects ate ad libitum. Total energy intake was estimated by food records. This study is registered on the Brazilian Registers of Clinical Trials-ReBEC (protocol: U1111-1203-9891).
RESULTS


We observed no significant difference in subjective appetite sensations between the groups. Food intake at lunch, as well as energy intake throughout the day also did not differ between the treatments.
CONCLUSION


Our results suggest that the acute intake of a shake containing nuts was not able to enhance satiety, compared to a shake matched for energy and macronutrient content. Further studies are warranted to elucidate the satiety mechanisms of nuts intake.",2021,We observed no significant difference in subjective appetite sensations between the groups.,['overweight subjects'],"['shake containing cashew and Brazil nuts', 'shake containing nuts, and a shake absent of nuts matched for energy and macronutrient content', 'shake containing 30\xa0g of cashew nuts (Anacardium occidentale L.) and 15\xa0g of Brazil nuts (Bertholletia excelsa H.B.K']","['Subjective appetite sensation', 'appetite responses', 'subjective appetite sensations', 'visual analogue scales (VAS', 'Food intake', 'Total energy intake']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0330953', 'cui_str': 'Anacardium occidentale'}, {'cui': 'C0440287', 'cui_str': 'Brazil nut'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0459815', 'cui_str': 'Cashew nut'}, {'cui': 'C0946580', 'cui_str': 'Brazil Nut Tree'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.0414084,We observed no significant difference in subjective appetite sensations between the groups.,"[{'ForeName': 'Mirian Aparecida de Campos', 'Initials': 'MAC', 'LastName': 'Costa', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Avenida PH Rolfs, s/n, Viçosa, MG, 36570-900, Brazil.'}, {'ForeName': 'Helen Hermana Miranda', 'Initials': 'HHM', 'LastName': 'Hermsdorff', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Avenida PH Rolfs, s/n, Viçosa, MG, 36570-900, Brazil.'}, {'ForeName': 'Ana Paula Silva', 'Initials': 'APS', 'LastName': 'Caldas', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Avenida PH Rolfs, s/n, Viçosa, MG, 36570-900, Brazil.'}, {'ForeName': 'Daniela Mayumi Usuda Prado', 'Initials': 'DMUP', 'LastName': 'Rocha', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Avenida PH Rolfs, s/n, Viçosa, MG, 36570-900, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'da Silva', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Avenida PH Rolfs, s/n, Viçosa, MG, 36570-900, Brazil.'}, {'ForeName': 'Leandro Licursi', 'Initials': 'LL', 'LastName': 'de Oliveira', 'Affiliation': 'Department of General Biology, Universidade Federal de Viçosa, Viçosa, MG, Brazil.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Bressan', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Avenida PH Rolfs, s/n, Viçosa, MG, 36570-900, Brazil. jbrm@ufv.br.'}]",European journal of nutrition,['10.1007/s00394-021-02560-w']
1273,34049857,Treatment failure in giant cell arteritis.,"OBJECTIVE


Identify predictors of treatment failure in patients with giant cell arteritis (GCA) receiving tocilizumab in combination with glucocorticoids and in patients with GCA receiving only glucocorticoids.
METHODS


Posthoc analysis of the Giant-Cell Arteritis Actemra trial including 250 patients who received tocilizumab every week plus a 26-week prednisone taper (n=100), tocilizumab every-other-week plus a 26-week prednisone taper (n=49) or placebo plus a 26-week (n=50) or 52-week (n=51) prednisone taper in the intention-to-treat population. Responders for this analysis were patients who maintained remission (no GCA signs/symptoms and no erythrocyte sedimentation rate elevation) through week 52. Treatment failure was defined as inability to achieve remission by week 12 or relapse between weeks 12 and 52. Predictors investigated in univariate and multivariable analyses included patient characteristics, disease-related and treatment-related factors and patient-reported outcomes (PROs).
RESULTS


149 patients received tocilizumab plus prednisone (TCZ/PDN) and 101 received placebo plus prednisone (PBO+PDN). After adjustment for confounders, treatment failure was significantly less likely in the TCZ/PDN group than the PBO/PDN group (OR, 0.2; 95% CI, 0.1 to 0.3; p<0.0001). Risk for treatment failure was significantly higher in women than men in the PBO/PDN group (OR, 5.2; 95% CI, 1.6 to 17.2; p=0.007) but not in the TCZ/PDN group. Predictors of treatment failure in the TCZ/PDN group included lower baseline prednisone doses and worse PROs at baseline.
CONCLUSION


The strongest risk factors for treatment failure in GCA are treatment with prednisone alone and female sex. Lower starting prednisone doses and impaired PROs are associated with failure to respond to tocilizumab.
TRIAL REGISTRATION NUMBER


NCT01791153.",2021,"After adjustment for confounders, treatment failure was significantly less likely in the TCZ/PDN group than the PBO/PDN group (OR, 0.2; 95% CI, 0.1 to 0.3; p<0.0001).","['patients with GCA receiving only glucocorticoids', '250 patients who received', 'Posthoc analysis of the Giant-Cell Arteritis', 'patients with giant cell arteritis']","['tocilizumab', 'glucocorticoids', 'prednisone taper', 'placebo plus prednisone (PBO+PDN', 'prednisone taper in the intention-to-treat population', 'prednisone', 'tocilizumab every-other-week plus a 26-week prednisone taper', 'placebo', 'tocilizumab plus prednisone (TCZ/PDN', 'TCZ/PDN']","['lower baseline prednisone doses and worse PROs', 'Risk for treatment failure', 'patient characteristics, disease-related and treatment-related factors and patient-reported outcomes (PROs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039483', 'cui_str': 'Giant cell arteritis'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",250.0,0.244396,"After adjustment for confounders, treatment failure was significantly less likely in the TCZ/PDN group than the PBO/PDN group (OR, 0.2; 95% CI, 0.1 to 0.3; p<0.0001).","[{'ForeName': 'Sebastian H', 'Initials': 'SH', 'LastName': 'Unizony', 'Affiliation': 'Vasculitis and Glomerulonephritis Center, Rheumatology, Immunology and Allergy Division, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Bao', 'Affiliation': 'Genentech Inc, South San Francisco, California, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Genentech Inc, South San Francisco, California, USA.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Luder', 'Affiliation': 'F Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Pavlov', 'Affiliation': 'Everest Clinical Research, Markham, Ontario, Canada.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stone', 'Affiliation': 'Vasculitis and Glomerulonephritis Center, Rheumatology, Immunology and Allergy Division, Massachusetts General Hospital, Boston, Massachusetts, USA JHSTONE@mgh.harvard.edu.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2021-220347']
1274,32659235,Early Changes Over Time in the Radiographic Assessment of Lung Edema Score Are Associated With Survival in ARDS.,"BACKGROUND


The Radiographic Assessment of Lung Edema (RALE) score is associated with the severity of ARDS, and treatments targeted at reducing pulmonary edema such as conservative fluid management cause a reduction in RALE score over time.
RESEARCH QUESTION


Are early changes in RALE score over time associated with survival in patients with ARDS?
STUDY DESIGN AND METHODS


Data from patients enrolled in three centers in the Lung Imaging for Ventilation sEtting in ARDS (LIVE) trial with available chest radiographs at baseline (day 0) and days 2 or 3 were used. The RALE was scored by two independent reviewers. The primary end point was death by day 90, considering RALE score both at baseline and as a time-varying covariate in a marginal Cox survival model.
RESULTS


RALE was scored from 135, 64, and 88 radiographs on days 0, 2, and 3, respectively. Both baseline RALE (hazard ratio [HR] for each one-point increment, 1.04; 95% CI, 1.01-1.08; P = .006) and the change in RALE over time (HR for each one-point decrease per unit of time, 0.99; 95% CI, 0.99-0.99; P = .03) were associated with death by day 90, even after adjustment for age, sex, BMI, Simplified Acute Physiology Score II, vasopressor use, and total volume of fluids received since study entry.
INTERPRETATION


The change in RALE during the first days after ARDS onset is independently associated with survival and may be useful as a surrogate end point in future clinical trials of new therapeutics in ARDS.",2020,"Both baseline RALE (hazard ratio [HR] for each one-point increment, 1.04; 95% CI, 1.01-1.08; P = .006) and the change in RALE over time (HR for each one-point decrease per unit of time, 0.99;",['Data from patients enrolled in three centers in the Lung Imaging for Ventilation sEtting in ARDS (LIVE) trial with available chest radiographs at baseline (day 0) and days 2 or 3 were used'],[],"['death by day 90, considering RALE score', 'change in RALE over time (HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.131819,"Both baseline RALE (hazard ratio [HR] for each one-point increment, 1.04; 95% CI, 1.01-1.08; P = .006) and the change in RALE over time (HR for each one-point decrease per unit of time, 0.99;","[{'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Jabaudon', 'Affiliation': 'Department of Perioperative Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France; GReD, CNRS UMR 6293, INSERM U1103, Université Clermont Auvergne, Clermont-Ferrand, France; Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN. Electronic address: mjabaudon@chu-clermontferrand.fr.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Audard', 'Affiliation': 'Department of Perioperative Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France; GReD, CNRS UMR 6293, INSERM U1103, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics and Data Management Unit, Department of Clinical Research and Innovation (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Montpellier University Hospital, Saint Eloi Intensive Care Unit and PhyMedExp, University of Montpellier, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Lefrant', 'Affiliation': 'Service de Recherche Clinique en Soins Critiques, Pôle Anesthésie Douleur Urgences Réanimation, Centre Hospitalier Universitaire de Nîmes, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Raiko', 'Initials': 'R', 'LastName': 'Blondonnet', 'Affiliation': 'Department of Perioperative Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France; GReD, CNRS UMR 6293, INSERM U1103, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Godet', 'Affiliation': 'Department of Perioperative Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': 'Department of Perioperative Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France; GReD, CNRS UMR 6293, INSERM U1103, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Biostatistics and Data Management Unit, Department of Clinical Research and Innovation (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Etienne', 'Initials': 'JE', 'LastName': 'Bazin', 'Affiliation': 'Department of Perioperative Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Bastarache', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; Departments of Cell and Developmental Biology, Vanderbilt University, Nashville, TN; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Constantin', 'Affiliation': 'Sorbonne University, GRC 29, AP-HP, DMU DREAM, Department of Anesthesiology and Critical Care, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Ware', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.06.070']
1275,33993331,Final diagnosis and patient disposition following equivocal results on 2-mSv CT vs. conventional-dose CT in adolescents and young adults with suspected appendicitis: a post hoc analysis of large pragmatic randomized trial data.,"OBJECTIVE


To compare 2-mSv CT and conventional-dose CT (CDCT, typically 7-8 mSv) regarding final diagnosis and patient disposition following equivocal CT results in adolescents and young adults with suspected appendicitis.
METHODS


In total, 3074 patients of 15-44 years (28 ± 9 years, 1672 women) from 20 hospitals were randomized to undergo contrast-enhanced 2-mSv CT (n = 1535) or CDCT (n = 1539) from December 2013 through August 2016. One hundred sixty-one radiologists prospectively rated the likelihood of appendicitis in a Likert scale (i.e., grades 1-5). The final diagnosis was based on CT image, surgical, pathologic, and clinical findings. Post hoc analysis was performed for final diagnosis, surgical procedure, and delay in patient management following equivocal results (i.e., grade 3).
RESULTS


The 2-mSv CT and CDCT groups were comparable for final diagnosis following equivocal results, including confirmed appendicitis (1.2% [18 patients] vs. 1.2% [19], p > 0.99), negative appendectomy (0.1% [2] vs. 0.3% [4], p = 0.53), and perforated appendicitis (0.1% [1] vs. 0.2% [3], p = 0.53). More patients were confirmed as not having appendicitis following equivocal results in the CDCT group than in the 2-mSv CT group (2.2% [34] vs. 1.0% [16], p = 0.016). The two groups were comparable for the need of appendectomy (1.4% [22] vs. 1.5% [23], p > 0.99), need of additional imaging tests (0.7% [11] vs. 1.1% [17], p = 0.35), and delay in patient management following equivocal results.
CONCLUSION


2-mSv CT is comparable to CDCT regarding final diagnosis and patient disposition following equivocal CT results.
KEY POINTS


• Our results strengthen evidence justifying the use of low-dose CT instead of conventional-dose CT (CDCT) in adolescents and young adults with suspected appendicitis. • The 2-mSv CT and CDCT groups were comparable for final diagnosis following equivocal CT results, including confirmed appendicitis (1.2% vs. 1.2%, p > 0.99), negative appendectomy (0.1% vs. 0.3%, p = 0.53), and perforated appendicitis (0.1% vs. 0.2%, p = 0.53). • The two groups were comparable for the need for appendectomy (1.4% vs. 1.5%, p > 0.99), need for additional imaging tests (0.7% vs. 1.1%, p = 0.35), and delay in patient management, following equivocal CT results.",2021,Our results strengthen evidence justifying the use of low-dose CT instead of conventional-dose CT (CDCT) in adolescents and young adults with suspected appendicitis.,"['One hundred sixty-one radiologists prospectively rated the likelihood of appendicitis in a Likert scale (i.e., grades 1-5', '3074 patients of 15-44 years (28 ± 9 years, 1672 women) from 20 hospitals', 'adolescents and young adults with suspected appendicitis', 'n = 1539) from December 2013 through August 2016']","['undergo contrast-enhanced 2-mSv CT', 'CDCT', '2-mSv CT and conventional-dose CT (CDCT, typically 7-8 mSv', 'conventional-dose CT (CDCT', '2-mSv CT', '2-mSv CT vs. conventional-dose CT']","['need of appendectomy', 'need of additional imaging tests', 'need for appendectomy', 'confirmed appendicitis', 'perforated appendicitis', 'negative appendectomy']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",3074.0,0.0464771,Our results strengthen evidence justifying the use of low-dose CT instead of conventional-dose CT (CDCT) in adolescents and young adults with suspected appendicitis.,"[{'ForeName': 'Jungheum', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.'}, {'ForeName': 'Seungjae', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Applied Bioengineering, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Hooney Daniel', 'Initials': 'HD', 'LastName': 'Min', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.'}, {'ForeName': 'Hae Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.'}, {'ForeName': 'Yousun', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'Biomedical Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.'}, {'ForeName': 'Sung Bin', 'Initials': 'SB', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, 102, Heukseok-ro, Dongjak-gu, Seoul, 06973, Korea. pksungbin@paran.com.'}, {'ForeName': 'Kyoung Ho', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European radiology,['10.1007/s00330-021-08020-7']
1276,34003418,Psychological and behavioral pathways between perceived stress and weight change in a behavioral weight loss intervention.,"Black women have a higher prevalence of obesity and tend to have suboptimal outcomes in behavioral weight loss programs for reasons that are not fully understood. Studies have shown a potential relationship between perceived psychological stress and weight loss in behavioral interventions. This study sought to assess whether baseline stress was directly or indirectly associated with 6-month weight change among Black women participating in a behavioral weight loss study. Indirect pathways of interest included depressive symptoms and dietary intake. A secondary analysis of data (n = 409) collected from a cluster, randomized behavioral weight loss trial was conducted. Demographics, anthropometry, surveys, and dietary data were collected at baseline and 6 months. Path analysis was used to test for direct and indirect effects of baseline stress on 6-month weight change while controlling for sociodemographic factors and intervention group. Baseline stress was not directly associated with 6-month weight change nor was it indirectly associated via depressive symptoms in the adjusted model. However, each of the direct paths linking baseline stress to weight loss were statistically significant. Stress was not associated with 6-month weight change via dietary intake. Baseline stress was positively associated with 6-month depressive symptoms which in turn was associated with less weight change. Depressive symptoms may offer an additional psychosocial target to consider when designing behavioral weight loss interventions for Black women.",2021,Baseline stress was not directly associated with 6-month weight change nor was it indirectly associated via depressive symptoms in the adjusted model.,"['Black women participating in a behavioral weight loss study', 'Black women']",[],"['weight loss', 'Demographics, anthropometry, surveys, and dietary data', 'weight change', '6-month weight change via dietary intake', '6-month depressive symptoms', 'Depressive symptoms']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.109104,Baseline stress was not directly associated with 6-month weight change nor was it indirectly associated via depressive symptoms in the adjusted model.,"[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Molina', 'Affiliation': 'Department of Psychological Sciences, University of California Irvine, Irvine, CA, USA.'}, {'ForeName': 'Monica L', 'Initials': 'ML', 'LastName': 'Baskin', 'Affiliation': 'School of Medicine, Department of Medicine, Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': 'School of Public Health, Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Carson', 'Affiliation': 'Department of Health Outcomes and Behavior, Division of Population Sciences, H. Lee Moffitt Cancer Center & Research Institute, MFC-EDU, 12902 Magnolia Drive, Tampa, FL, 33612, USA. tiffany.carson@moffitt.org.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00231-z']
1277,34010679,IMACTIV: A Pilot Study of the Impact of Unrestricted Activity Following Urethral Sling Surgery.,"OBJECTIVES


To compare continence outcomes and health-related quality of life (HRQOL) among women with limited activity restrictions vs traditional restrictions following mid-urethral sling (MUS) surgery.
METHODS


Thirty-six women who underwent MUS surgery were randomized: (1) the Restrictions group was given traditional postoperative restrictions for 6 weeks while (2) the Limited Restrictions group was instructed to resume normal activities other than pelvic rest. Patients undergoing concomitant surgery for Stage III and IV prolapse were excluded. Participants completed questionnaires related to urinary symptoms (UDI-6, IIQ-7) for continence outcomes and HRQOL (SF-12) at baseline, 1 to 6 weeks, 3 months, 6 months, and at least 1 year after surgery.
RESULTS


There was no difference in mean scores on the UDI-6 or IIQ-7 between groups at baseline or any time after surgery. The Limited Restrictions group reported better scores than the Restrictions group on the SF-12 mental health component at 1 week (56.7 vs 50.2, P = .01) and 4 weeks (58.4 vs 53.3, P = .04). The Restrictions group reported better SF-12 physical health scores at 5 weeks (55.7 vs 53.0, P = .02) but there was no difference in HRQOL scores between the two groups at any other time.
CONCLUSION


In this pilot study, there was no difference in continence outcomes for women with traditional vs limited activity restrictions following MUS surgery. There were differences in HRQOL in the early post-operative period, but these differences were not sustained. Larger prospective studies are needed, but it appears that activity restrictions after MUS surgery may not be necessary.",2021,"The Limited Restrictions group reported better scores than the Restrictions group on the SF-12® mental health component at one week (56.7 vs. 50.2, p=0.01) and four weeks (58.4 vs. 53.3, p=0.04).","['women with limited activity restrictions vs. traditional restrictions following mid-urethral sling (MUS) surgery', 'women with traditional versus limited activity restrictions following MUS surgery', 'Thirty-six women who underwent MUS surgery', 'Patients undergoing concomitant surgery for Stage 3 and 4 prolapse were excluded']","['Urethral Sling Surgery', 'IMACTIV', 'Restrictions group was given traditional postoperative restrictions for six weeks while 2']","['continence outcomes', 'mean scores on the UDI-6 or IIQ-7', 'HRQOL', 'HRQOL scores', 'continence outcomes and health-related quality of life (HRQOL', 'SF-12® mental health component', 'SF-12® physical health scores', 'urinary symptoms (UDI-6, IIQ-7) for continence outcomes and HRQOL (SF-12®']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C3179500', 'cui_str': 'Urethral Slings'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}]",36.0,0.101231,"The Limited Restrictions group reported better scores than the Restrictions group on the SF-12® mental health component at one week (56.7 vs. 50.2, p=0.01) and four weeks (58.4 vs. 53.3, p=0.04).","[{'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Tholemeier', 'Affiliation': 'Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bresee', 'Affiliation': 'Biostatistics Core at the Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Colby P', 'Initials': 'CP', 'LastName': 'Souders', 'Affiliation': 'Department of Urology, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Falisha F', 'Initials': 'FF', 'LastName': 'Kanji', 'Affiliation': 'Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Anger', 'Affiliation': 'Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, CA; Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Karyn S', 'Initials': 'KS', 'LastName': 'Eilber', 'Affiliation': 'Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, CA; Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA. Electronic address: karyn.eilber@cshs.org.'}]",Urology,['10.1016/j.urology.2021.05.004']
1278,34019214,"Combination therapy of capecitabine, irinotecan, oxaliplatin, and bevacizumab as a first-line treatment for metastatic colorectal cancer: Safety lead-in results from the QUATTRO-II study.","Background FOLFOXIRI plus bevacizumab is the first-line treatment for metastatic colorectal cancer (mCRC) but demonstrates high neutropenia incidence among Asian patients. Hence, we conducted the randomized phase II QUATTRO-II study (ClinicalTrials.gov identifier: NCT04097444; Japan Registry of Clinical Trials identifier: jRTCs041190072) to evaluate the safety and efficacy of capecitabine, oxaliplatin, and irinotecan (CAPOXIRI) combination plus bevacizumab versus FOLFOXIRI plus bevacizumab, expecting a lower incidence of neutropenia without compromising the efficacy. Methods We investigated the recommended doses (RD) of oxaliplatin and irinotecan as a safety lead-in portion of Step 1 before initiating the randomized portion as Step 2. Four dose levels of CAPOXIRI (fixed dose of capecitabine, 1600 mg/m 2 ; escalated/de-escalated doses of oxaliplatin and irinotecan) plus bevacizumab (7.5 mg/kg) were investigated in a 3 + 3 manner. A dose level of ≤ 2/6 of dose-limiting toxicity (DLT) cases was expected as the RD. Results In Step 1, we included nine patients (three and six in levels 0 and + 1, respectively). Level 0 (irinotecan, 200 mg/m 2 ; oxaliplatin, 100 mg/m 2 ) did not demonstrate DLTs. In level + 1 (irinotecan, 200 mg/m 2 ; oxaliplatin, 130 mg/m 2 ), although one patient experienced grade 4 febrile neutropenia, no further safety concerns were observed. As a preliminary efficacy result, the objective response rate in all nine patients was 89 % (100 and 83 % in levels 0 and + 1, respectively). Conclusions The RD of CAPOXIRI plus bevacizumab was 200, 130, and 1600 mg/m 2  for irinotecan, oxaliplatin, and capecitabine, respectively, and 7.5 mg/kg for bevacizumab. The randomized portion is still ongoing.",2021,"As a preliminary efficacy result, the objective response rate in all nine patients was 89 % (100 and 83 % in levels 0 and + 1, respectively).","['all nine patients was 89\u2009% (100 and 83\u2009% in levels 0 and +\u20091, respectively', 'Asian patients', 'metastatic colorectal cancer', '1600', 'metastatic colorectal cancer (mCRC']","['oxaliplatin and irinotecan', 'oxaliplatin', 'irinotecan, oxaliplatin, and capecitabine', 'capecitabine, irinotecan, oxaliplatin, and bevacizumab', 'bevacizumab', 'Level 0 (irinotecan, 200\xa0mg/m 2 ; oxaliplatin, 100\xa0mg/m 2 ) did not demonstrate DLTs', 'oxaliplatin and irinotecan) plus bevacizumab', 'capecitabine, oxaliplatin, and irinotecan (CAPOXIRI) combination plus bevacizumab versus FOLFOXIRI plus bevacizumab']","['grade 4 febrile neutropenia', 'objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C4517592', 'cui_str': '1600'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",9.0,0.0357042,"As a preliminary efficacy result, the objective response rate in all nine patients was 89 % (100 and 83 % in levels 0 and + 1, respectively).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kotani', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa City, Chiba, 277-8577, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa City, Chiba, 277-8577, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Kawazoe', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa City, Chiba, 277-8577, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Masuishi', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa City, Chiba, 277-8577, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Komatsu', 'Affiliation': 'Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hironaga', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Cancer Treatment Center, Kansai Medical University Hospital, Hirakata City, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Kagawa University Hospital, 1750-1 Ikenobe, Kita District, Miki, Kagawa, 761-0793, Japan. atsuji@med.kagawa-u.ac.jp.'}]",Investigational new drugs,['10.1007/s10637-021-01125-2']
1279,34016263,Fat-Secreted Ceramides Regulate Vascular Redox State and Influence Outcomes in Patients With Cardiovascular Disease.,"BACKGROUND


Obesity is associated with increased cardiovascular risk; however, the potential role of dysregulations in the adipose tissue (AT) metabolome is unknown.
OBJECTIVES


The aim of this study was to explore the role of dysregulation in the AT metabolome on vascular redox signaling and cardiovascular outcomes.
METHODS


A screen was conducted for metabolites differentially secreted by thoracic AT (ThAT) and subcutaneous AT in obese patients with atherosclerosis (n = 48), and these metabolites were then linked with dysregulated vascular redox signaling in 633 patients undergoing coronary bypass surgery. The underlying mechanisms were explored in human aortic endothelial cells, and their clinical value was tested against hard clinical endpoints.
RESULTS


Because ThAT volume was associated significantly with arterial oxidative stress, there were significant differences in sphingolipid secretion between ThAT and subcutaneous AT, with C16:0-ceramide and derivatives being the most abundant species released within adipocyte-derived extracellular vesicles. High ThAT sphingolipid secretion was significantly associated with reduced endothelial nitric oxide bioavailability and increased superoxide generated in human vessels. Circulating C16:0-ceramide correlated positively with ThAT ceramides, dysregulated vascular redox signaling, and increased systemic inflammation in 633 patients with atherosclerosis. Exogenous C16:0-ceramide directly increased superoxide via tetrahydrobiopterin-mediated endothelial nitric oxide synthase uncoupling and dysregulated protein phosphatase 2 in human aortic endothelial cells. High plasma C16:0-ceramide and its glycosylated derivative were independently related with increased risk for cardiac mortality (adjusted hazard ratios: 1.394; 95% confidence interval: 1.030 to 1.886; p = 0.031 for C16:0-ceramide and 1.595; 95% confidence interval: 1.042 to 2.442; p = 0.032 for C16:0-glycosylceramide per 1 SD). In a randomized controlled clinical trial, 1-year treatment of obese patients with the glucagon-like peptide-1 analog liraglutide suppressed plasma C16:0-ceramide and C16:0-glycosylceramide changes compared with control subjects.
CONCLUSIONS


These results demonstrate for the first time in humans that AT-derived ceramides are modifiable regulators of vascular redox state in obesity, with a direct impact on cardiac mortality in advanced atherosclerosis. (The Interaction Between Appetite Hormones; NCT02094183).",2021,High plasma C16:0-ceramide and its glycosylated derivative were independently related with increased risk for cardiac mortality (adjusted hazard ratios: 1.394; 95% confidence interval: 1.030 to 1.886; p = 0.031 for C16:0-ceramide and 1.595; 95% confidence interval: 1.042 to 2.442; p = 0.032 for C16:0-glycosylceramide per 1 SD).,"['633 patients with atherosclerosis', 'Patients With Cardiovascular Disease', 'obese patients with the', '633 patients undergoing coronary bypass surgery', 'obese patients with atherosclerosis (n\xa0=\xa048']",['glucagon-like peptide-1 analog liraglutide'],"['arterial oxidative stress', 'endothelial nitric oxide bioavailability', 'sphingolipid secretion', 'vascular redox signaling and cardiovascular outcomes', 'cardiac mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0037900', 'cui_str': 'Sphingolipid'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",633.0,0.151387,High plasma C16:0-ceramide and its glycosylated derivative were independently related with increased risk for cardiac mortality (adjusted hazard ratios: 1.394; 95% confidence interval: 1.030 to 1.886; p = 0.031 for C16:0-ceramide and 1.595; 95% confidence interval: 1.042 to 2.442; p = 0.032 for C16:0-glycosylceramide per 1 SD).,"[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Akawi', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom; Department of Genetics and Genomics, College of Medicine and Health Sciences, United Arab Emirates University, Al-Ain, United Arab Emirates. Electronic address: https://twitter.com/NadiaAkawi.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Checa', 'Affiliation': 'Division of Physiological Chemistry II, Department of Medical Biochemistry and Biophysics, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Alexios S', 'Initials': 'AS', 'LastName': 'Antonopoulos', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Akoumianakis', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Daskalaki', 'Affiliation': 'Division of Physiological Chemistry II, Department of Medical Biochemistry and Biophysics, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Christos P', 'Initials': 'CP', 'LastName': 'Kotanidis', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Kondo', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Dilan', 'Initials': 'D', 'LastName': 'Yesilyurt', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ileana', 'Initials': 'I', 'LastName': 'Badi', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Polkinghorne', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Akbar', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Surawee', 'Initials': 'S', 'LastName': 'Chuaiphichai', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Choudhury', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Neubauer', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Channon', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Signe S', 'Initials': 'SS', 'LastName': 'Torekov', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Wheelock', 'Affiliation': 'Division of Physiological Chemistry II, Department of Medical Biochemistry and Biophysics, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Antoniades', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: antoniad@well.ox.ac.uk.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.03.314']
1280,34021094,Continuous Versus Intermittent Running: Acute Performance Decrement and Training Load.,"PURPOSE


To examine the effect of continuous (CON) and intermittent (INT) running training sessions of different durations and intensities on subsequent performance and calculated training load (TL).
METHODS


Runners (N = 11) performed a 1500-m time trial as a baseline and after completing 4 different running training sessions. The training sessions were performed in a randomized order and were either maximal for 10 minutes (10CON and 10INT) or submaximal for 25 minutes (25CON and 25INT). An acute performance decrement (APD) was calculated as the percentage change in 1500-m time-trial speed measured after training compared with baseline. The pattern of APD response was compared with that for several TL metrics (bTRIMP, eTRIMP, iTRIMP, running training stress score, and session rating of perceived exertion) for the respective training sessions.
RESULTS


Average speed (P < .001, ηp2=.924) was different for each of the initial training sessions, which all resulted in a significant APD. This APD was similar when compared across the sessions except for a greater APD found after 10INT versus 25CON (P = .02). In contrast, most TL metrics were different and showed the opposite response to APD, being higher for CON versus INT and lower for 10- versus 25-minute sessions (P < .001, ηp2>.563).
CONCLUSION


An APD was observed consistently after running training sessions, but it was not consistent with most of the calculated TL metrics. The lack of agreement found between APD and TL suggests that current methods for quantifying TL are flawed when used to compare CON and INT running training sessions of different durations and intensities.",2021,"RESULTS


Average speed (P < .001, ηp2=.924) was different for each of the initial training sessions, which all resulted in a significant APD.",['Runners (N = 11'],"['continuous (CON) and intermittent (INT) running training sessions', 'Continuous Versus Intermittent Running', 'maximal for 10\xa0minutes (10CON and 10INT) or submaximal for 25\xa0minutes (25CON and 25INT']","['several TL metrics (bTRIMP, eTRIMP, iTRIMP, running training stress score, and session rating of perceived exertion', 'acute performance decrement (APD', 'Acute Performance Decrement and Training Load']",[],"[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0124097,"RESULTS


Average speed (P < .001, ηp2=.924) was different for each of the initial training sessions, which all resulted in a significant APD.","[{'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Kesisoglou', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Nicolò', 'Affiliation': ''}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Howland', 'Affiliation': ''}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Passfield', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0844']
1281,34039769,A Comparison of Training With a Velocity Loss Threshold or to Repetition Failure on Upper-Body Strength Development in Professional Australian Footballers.,"PURPOSE


To compare resistance training using a velocity loss threshold with training to repetition failure on upper-body strength parameters in professional Australian footballers.
METHODS


A total of 26 professional Australian footballers (23.9 [4.2] y, 189.9 [7.8] cm, 88.2 [8.8] kg) tested 1-repetition-maximum strength (FPmax) and mean barbell velocity at 85% of 1-repetition maximum on floor press (FPvel). They were then assigned to 2 training groups: 20% velocity loss threshold training (VL; n = 12, maximum-effort lift velocity) or training to repetition failure (TF; n = 14, self-selected lift velocity). Subjects trained twice per week for 3 weeks before being reassessed on FPmax and FPvel. Training volume (total repetitions) was recorded for all training sessions. No differences were present between groups on any pretraining measure.
RESULTS


The TF group significantly improved FPmax (105.2-110.9 kg, +5.4%), while the VL group did not (107.5-109.2 kg, +1.6%) (P > .05). Both groups significantly increased FPvel (0.38-0.46 m·s-1, +19.1% and 0.37-0.42 m·s-1, +16.7%, respectively) with no between-groups differences evident (P > .05). The TF group performed significantly more training volume (12.2 vs 6.8 repetitions per session, P > .05).
CONCLUSIONS


Training to repetition failure improved FPmax, while training using a velocity loss threshold of 20% did not. Both groups demonstrated similar improvements in FPvel despite the VL group completing 45% less total training volume than the TF group. The reduction in training volume associated with implementing a 20% velocity loss threshold may negatively impact the development of upper-body maximum strength while still enhancing submaximal movement velocity.",2021,Both groups demonstrated similar improvements in FPvel despite the VL group completing 45% less total training volume than the TF group.,"['A total of 26 professional Australian footballers (23.9 [4.2]\xa0y, 189.9 [7.8]\xa0cm, 88.2 [8.8]\xa0kg) tested 1-repetition-maximum strength (FPmax) and mean barbell velocity at 85% of 1-repetition maximum on floor press (FPvel', 'Professional Australian Footballers']","['velocity loss threshold training (VL; n = 12, maximum-effort lift velocity) or training to repetition failure (TF; n = 14, self-selected lift velocity', 'Training With a Velocity Loss Threshold or to Repetition Failure']","['FPvel', 'Training volume (total repetitions', 'training volume', 'total training volume', 'FPmax']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0233742', 'cui_str': 'Repetition failure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",26.0,0.00371943,Both groups demonstrated similar improvements in FPvel despite the VL group completing 45% less total training volume than the TF group.,"[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Kilgallon', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Johnston', 'Affiliation': ''}, {'ForeName': 'Liam P', 'Initials': 'LP', 'LastName': 'Kilduff', 'Affiliation': ''}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Watsford', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0882']
1282,34044369,"The Effects of an Acute ""Train-Low"" Nutritional Protocol on Markers of Recovery Optimization in Endurance-Trained Male Athletes.","PURPOSE


This study aimed to determine the effects of an acute ""train-low"" nutritional protocol on markers of recovery optimization compared to standard recovery nutrition protocol.
METHODS


After completing a 2-hour high-intensity interval running protocol, 8 male endurance athletes consumed a standard dairy milk recovery beverage (CHO; 1.2 g/kg body mass [BM] of carbohydrate and 0.4 g/kg BM of protein) and a low-carbohydrate (L-CHO; isovolumetric with 0.35 g/kg BM of carbohydrate and 0.5 g/kg BM of protein) dairy milk beverage in a double-blind randomized crossover design. Venous blood and breath samples, nude BM, body water, and gastrointestinal symptom measurements were collected preexercise and during recovery. Muscle biopsy was performed at 0 hour and 2 hours of recovery. Participants returned to the laboratory the following morning to measure energy substrate oxidation and perform a 1-hour distance test.
RESULTS


The exercise protocol resulted in depletion of muscle glycogen stores (250 mmol/kg dry weight) and mild body-water losses (BM loss = 1.8%). Neither recovery beverage replenished muscle glycogen stores (279 mmol/kg dry weight) or prevented a decrease in bacterially stimulated neutrophil function (-21%). Both recovery beverages increased phosphorylation of mTORSer2448 (main effect of time = P < .001) and returned hydration status to baseline. A greater fold increase in p-GSK-3βSer9/total-GSK-3β occurred on CHO (P = .012). Blood glucose (P = .005) and insulin (P = .012) responses were significantly greater on CHO (618 mmol/L per 2 h and 3507 μIU/mL per 2 h, respectively) compared to L-CHO (559 mmol/L per 2 h and 1147 μIU/mL per 2 h, respectively). Rates of total fat oxidation were greater on CHO, but performance was not affected.
CONCLUSION


A lower-carbohydrate recovery beverage consumed after exercise in a ""train-low"" nutritional protocol does not negatively impact recovery optimization outcomes.",2021,Both recovery beverages increased phosphorylation of mTORSer2448 (main effect of time = P < .001) and returned hydration status to baseline.,['Endurance-Trained Male Athletes'],"['acute ""train-low"" nutritional protocol', 'L-CHO', 'Acute ""Train-Low"" Nutritional Protocol', 'male endurance athletes consumed a standard dairy milk recovery beverage (CHO; 1.2\xa0g/kg body mass [BM]\xa0of carbohydrate and 0.4\xa0g/kg BM of protein) and a low-carbohydrate (L-CHO; isovolumetric with 0.35\xa0g/kg BM of carbohydrate and 0.5\xa0g/kg BM of protein) dairy milk beverage', 'CHO']","['Venous blood and breath samples, nude BM, body water, and gastrointestinal symptom measurements', 'p-GSK-3βSer9/total-GSK-3β', 'Rates of total fat oxidation', 'bacterially stimulated neutrophil function', 'Blood glucose', 'recovery beverage replenished muscle glycogen stores', 'depletion of muscle glycogen stores']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025932', 'cui_str': 'Mouse, Nude'}, {'cui': 'C0005909', 'cui_str': 'Body water'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}]",8.0,0.13362,Both recovery beverages increased phosphorylation of mTORSer2448 (main effect of time = P < .001) and returned hydration status to baseline.,"[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Russo', 'Affiliation': ''}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Della Gatta', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Garnham', 'Affiliation': ''}, {'ForeName': 'Judi', 'Initials': 'J', 'LastName': 'Porter', 'Affiliation': ''}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Burke', 'Affiliation': ''}, {'ForeName': 'Ricardo J S', 'Initials': 'RJS', 'LastName': 'Costa', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0847']
1283,34044367,Morning Preconditioning Exercise Does Not Increase Afternoon Performance in Competitive Runners.,"PURPOSE


Preconditioning exercise is a widely used strategy believed to enhance performance later the same day. The authors examined the influence of preconditioning exercises 6 hours prior to a time-to-exhaustion (TTE) test during treadmill running.
METHODS


Ten male competitive runners (age = 26 [3] y, height = 184 [8] cm, weight = 73 [9] kg, maximum oxygen consumption = 72 [7] mL·kg-1·min-1) did a preconditioning session of running (RUN) or resistance exercise (RES) or no morning exercise (NoEx) in a randomized order, separated by >72 hours. The RUN consisted of 15 minutes of low-intensity running and 4 × 15 seconds at race pace (21-24 km·h-1) on a treadmill; RES involved 5 minutes of low-intensity running and 2 × 3 repetitions of isokinetic 1-leg shallow squats with maximal mobilization. Following a 6-hour break, electrically evoked force (m. vastus medialis), countermovement jump, running economy, and a TTE of approximately 2 minutes were examined.
RESULTS


Relative to NoEx, no difference was seen for RUN or RES in TTE (mean ± 95% CI: -1.3% ± 3.4% and -0.5% ± 6.0%) or running economy (0.2% ± 1.6% and 1.9% ± 2.7%; all Ps > .05). Jump height was not different for the RUN condition (1.0% ± 2.7%]) but tended to be higher in RES than in the NoEx condition (1.5% ± 1.6%, P = .07). The electrically evoked force tended to reveal low-frequency fatigue (reduced 20:50-Hz peak force ratio) only after RES compared to NoEx (-4.5% ± 4.6%, P = .06).
CONCLUSION


The RUN or RES 6 hours prior to approximately 2 minutes of TTE running test did not improve performance in competitive runners.",2021,"The electrically evoked force tended to reveal low-frequency fatigue (reduced 20:50-Hz peak force ratio) only after RES compared to NoEx (-4.5% ± 4.6%, P = .06).
","['3]\xa0y, height = 184 [8]\xa0cm, weight = 73', 'Ten male competitive runners (age = 26', 'Competitive Runners']","['mL·kg-1·min-1', 'preconditioning session of running (RUN) or resistance exercise (RES) or no morning exercise (NoEx', 'treadmill; RES involved 5 minutes of low-intensity running and 2 × 3 repetitions of isokinetic 1-leg shallow squats with maximal mobilization', 'preconditioning exercises', 'Morning Preconditioning Exercise']","['Jump height', 'Afternoon Performance', 'maximum oxygen consumption = 72 [7']","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",10.0,0.0554848,"The electrically evoked force tended to reveal low-frequency fatigue (reduced 20:50-Hz peak force ratio) only after RES compared to NoEx (-4.5% ± 4.6%, P = .06).
","[{'ForeName': 'Even Brøndbo', 'Initials': 'EB', 'LastName': 'Dahl', 'Affiliation': ''}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Øygard', 'Affiliation': ''}, {'ForeName': 'Gøran', 'Initials': 'G', 'LastName': 'Paulsen', 'Affiliation': ''}, {'ForeName': 'Bjarne', 'Initials': 'B', 'LastName': 'Rud', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Losnegard', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0747']
1284,34033222,"Targeting CXCR1/2 in the first multicenter, double-blinded, randomized trial in autologous islet transplant recipients.","Several cytokines and chemokines are elevated after islet infusion in patients undergoing total pancreatectomy with islet autotransplantation (TPIAT), including CXCL8 (also known as interleukin-8), leading to islet loss. We investigated whether use of reparixin for blockade of the CXCL8 pathway would improve islet engraftment and insulin independence after TPIAT. Adults without diabetes scheduled for TPIAT at nine academic centers were randomized to a continuous infusion of reparixin or placebo (double-blinded) for 7 days in the peri-transplant period. Efficacy measures included insulin independence (primary), insulin dose, hemoglobin A 1c  (HbA 1c  ), and mixed meal tolerance testing. The intent-to-treat population included 102 participants (age 39.5 ± 12.2 years, 69% female), n = 50 reparixin-treated, n = 52 placebo-treated. The proportion insulin-independent at Day 365 was similar in reparixin and placebo: 20% vs. 21% (p = .542). Twenty-seven of 42 (64.3%) in the reparixin group and 28/45 (62.2%) in the placebo group maintained HbA 1c  ≤6.5% (p = .842, Day 365). Area under the curve C-peptide from mixed meal testing was similar between groups, as were adverse events. In conclusion, reparixin infusion did not improve diabetes outcomes. CXCL8 inhibition alone may be insufficient to prevent islet damage from innate inflammation in islet autotransplantation. This first multicenter clinical trial in TPIAT highlights the potential for future multicenter collaborations.",2021,"Several cytokines and chemokines are elevated after islet infusion in patients undergoing total pancreatectomy with islet autotransplantation (TPIAT), including CXCL8 (also known as interleukin-8), leading to islet loss.","['102 participants (age 39.5±12.2 years, 69% female), n=50 reparixin-treated, n=52 placebo-treated', 'autologous islet transplant recipients', 'Adults without diabetes scheduled for TPIAT at 9 academic centers', 'patients undergoing total pancreatectomy with islet autotransplantation (TPIAT']","['reparixin or placebo', 'CXCL8', 'placebo', 'reparixin infusion']","['proportion insulin', 'diabetes outcomes', 'insulin independence (primary), insulin dose, hemoglobin A1c (HbA 1c  ), and mixed meal tolerance testing']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1506748', 'cui_str': 'reparixin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0376387', 'cui_str': 'Recipient, Transplant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040511', 'cui_str': 'Total pancreatectomy'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}]","[{'cui': 'C1506748', 'cui_str': 'reparixin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1698756', 'cui_str': 'CXCL8 protein, human'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",,0.473776,"Several cytokines and chemokines are elevated after islet infusion in patients undergoing total pancreatectomy with islet autotransplantation (TPIAT), including CXCL8 (also known as interleukin-8), leading to islet loss.","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Witkowski', 'Affiliation': 'The Transplantation Institute, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wijkstrom', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Piotr J', 'Initials': 'PJ', 'LastName': 'Bachul', 'Affiliation': 'The Transplantation Institute, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Morgan', 'Affiliation': 'The Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Levy', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Onaca', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Sushela S', 'Initials': 'SS', 'LastName': 'Chaidarun', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Gardner', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'A M James', 'Initials': 'AMJ', 'LastName': 'Shapiro', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Posselt', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Ahmad', 'Affiliation': 'University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Daffonchio', 'Affiliation': 'Research and Development, Dompé farmaceutici, Milan, Italy.'}, {'ForeName': 'Pier A', 'Initials': 'PA', 'LastName': 'Ruffini', 'Affiliation': 'Research and Development, Dompé farmaceutici, Milan, Italy.'}, {'ForeName': 'Melena D', 'Initials': 'MD', 'LastName': 'Bellin', 'Affiliation': 'University of Minnesota Medical Center, Minneapolis, Minnesota, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16695']
1285,34037715,"Ustekinumab in Paediatric Patients with Moderately to Severely Active Crohn's Disease: Pharmacokinetics, Safety, and Efficacy Results from UniStar, a Phase 1 Study.","BACKGROUND AND AIMS


The objective was to evaluate the pharmacokinetics, safety/tolerability, and efficacy of ustekinumab in children with moderately to severely active Crohn's disease.
METHODS


In this Phase 1, multicentre, 16-week, double-blind, induction dose-ranging study [NCT02968108], patients aged 2-<18 years [body weight ≥10 kg] were randomised [1:1] to one of two weight range-based intravenous induction doses: 130 mg vs 390 mg in patients ≥40kg and 3 mg/kg vs 9 mg/kg in patients <40kg. At Week 8, all patients received a single subcutaneous ustekinumab maintenance dose of 90 mg in patients ≥40kg or 2 mg/kg in patients <40kg.
RESULTS


A total of 44 patients were randomised and treated with ustekinumab [n = 23 lower dose; n = 21 higher dose]; median [interquartile range] age was 13.0 [12-16] years. Pharmacokinetics were similar to those in adults with Crohn's disease. However, serum ustekinumab concentrations were lower among those with body weight <40 kg compared with patients ≥40 kg and the reference Phase 3 adult population. Through Week 16, 73% of patients reported ≥1 adverse event [82.6% lower vs 62% higher dose]; two discontinued due to adverse events [one in each group]. Serious adverse events occurred in 16% [26% lower, 5% higher dose], with Crohn's disease exacerbation being the most frequent. At Week 16, 22%/29% [lower/higher dose] achieved clinical remission [Paediatric Crohn's Disease Activity Index ≤10].
CONCLUSIONS


The pharmacokinetics/safety profiles were generally consistent with those observed in adults with Crohn's disease. These results suggest a different dosing regimen may be required for patients <40 kg from that employed in this study; additional pharmacokinetic analyses may be needed in this population.",2021,"Serious adverse events occurred in 16% (26% lower, 5% higher dose), with Crohn's disease exacerbation being the most frequent.","['Pediatric Patients with Moderately to', 'Forty-four patients', ""children with moderately to severely active Crohn's disease"", ""adults with Crohn's disease"", 'patients aged 2-<18 years (body weight ≥10\xa0kg) were randomized (1:1']",['ustekinumab'],"['pharmacokinetics, safety/tolerability, and efficacy', 'Serious adverse events', 'serum ustekinumab concentrations', 'adverse event', 'pharmacokinetics/safety profiles', ""clinical remission (Pediatric Crohn's Disease Activity Index ≤10""]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C2931133', 'cui_str': ""Pediatric Crohn's disease""}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",44.0,0.353463,"Serious adverse events occurred in 16% (26% lower, 5% higher dose), with Crohn's disease exacerbation being the most frequent.","[{'ForeName': 'Joel R', 'Initials': 'JR', 'LastName': 'Rosh', 'Affiliation': ""Pediatric Gastroenterology, Goryeb Children's Hospital, Morristown, NJ,USA.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Pediatric Gastroenterology, Shaare Zedek Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Griffiths', 'Affiliation': 'Pediatric Gastroenterology, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Stanley A', 'Initials': 'SA', 'LastName': 'Cohen', 'Affiliation': ""Pediatric Gastroenterology, Children's Center of Digestive Health Care, Atlanta, GA, USA.""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Jacobstein', 'Affiliation': 'Provention Bio, Inc., Redbank, NJ, USA.'}, {'ForeName': 'Omoniyi J', 'Initials': 'OJ', 'LastName': 'Adedokun', 'Affiliation': 'Janssen Research and Development LLC, Spring House, PA, USA.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Padgett', 'Affiliation': 'Janssen Research and Development LLC, Spring House, PA, USA.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Terry', 'Affiliation': 'Janssen Research and Development LLC, Spring House, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Brien"", 'Affiliation': 'Janssen Research and Development LLC, Spring House, PA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Hyams', 'Affiliation': ""Pediatric Gastroenterology, Connecticut Children's Medical Center, Hartford, CT, USA.""}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjab089']
1286,34057269,The effect of preventive psychosocial interventions directed towards mothers and children on children's knowledge about protection from sexual abuse.,"PROBLEM


Sexual abuse is a multidimensional public health problem that concerns all communities. Primary-level preventive approaches in the fight against sexual abuse have an important place. However, research involving parents in sexual abuse prevention interventions with children is limited. The aim of this study is to determine the effect of preventive psychosocial interventions directed towards mothers and their children on children's knowledge about protection from sexual abuse.
METHODS


The study has a quasi-experimental, comparative design with a control group and a pretest/posttest. The participants were assigned into four groups; namely, control, mother psychoeducation, child psychoeducation and mother-child psychoeducation.
FINDINGS


Significant difference was determined within and between the groups in the mean scores of the Good Touch Bad Touch Curriculum test (p < 0.001).
CONCLUSION


The preventive psychosocial intervention simplemented to mothers and their children increase children's knowledge about protection from sexual abuse.",2021,"FINDINGS


Significant difference was determined within and between the groups in the mean scores of the Good Touch Bad Touch Curriculum test (p < 0.001).
","[""towards mothers and their children on children's knowledge about protection from sexual abuse"", ""mothers and children on children's knowledge about protection from sexual abuse""]","['control, mother psychoeducation, child psychoeducation and mother-child psychoeducation', 'preventive psychosocial interventions', 'preventive psychosocial interventions directed']",['mean scores of the Good Touch Bad Touch Curriculum test'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0278474,"FINDINGS


Significant difference was determined within and between the groups in the mean scores of the Good Touch Bad Touch Curriculum test (p < 0.001).
","[{'ForeName': 'Oya Sevcan', 'Initials': 'OS', 'LastName': 'Orak', 'Affiliation': 'Psychiatric Nursing Department, Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Okanli', 'Affiliation': 'Psychiatric Nursing Department, Faculty of Health Sciences, İstanbul Medeniyet University, İstanbul, Turkey.'}]","Journal of child and adolescent psychiatric nursing : official publication of the Association of Child and Adolescent Psychiatric Nurses, Inc",['10.1111/jcap.12334']
1287,34059326,Cost-Utility Analysis of Transarterial Radioembolization With Yttrium-90 Resin Microspheres Compared With Sorafenib in Locally Advanced and Inoperable Hepatocellular Carcinoma.,"PURPOSE


The SARAH (Sorafenib Versus Radioembolization in Advanced Hepatocellular Carcinoma) trial (ClinicalTrials.gov Identifier NCT01482442) did not show a significant survival benefit for patients treated with transarterial radioembolization (TARE) compared with continuous oral sorafenib. The improved toxicity profile of patients treated with TARE in the trial, however, could result in a quality of life benefit in economic evaluations. Our objective was to perform a cost-utility analysis of TARE versus sorafenib for locally advanced and inoperable hepatocellular carcinoma.
METHODS


This study used patient-level data of the SARAH trial regarding resource use, progression-free and overall survival, and quality of life for the within-trial period for the patients who received at least 1 dose of sorafenib or 1 treatment with TARE according to their randomization arm. Data were extrapolated by using a partitioned survival model that incorporated costs and health outcomes, measured in life-years and quality-adjusted life-years (QALYs).
FINDINGS


The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib. The aerage cost for the TARE arm was €17,179 (95% CI, 9,926-24,280) higher than the sorafenib arm, for an incremental cost-effectiveness ratio of €3,153,086/QALY. The probabilistic sensitivity analysis revealed a 50% risk that the TARE strategy was dominated. TARE was consistently dominated by sorafenib or had an incremental cost-effectiveness ratio more than €450,000/QALY in all sensitivity analyses.
IMPLICATIONS


This economic evaluation of SARAH found that using radioembolization with yttrium-90 microspheres for the treatment of hepatocellular carcinoma was not a cost-effective option at the usually accepted willingness-to-pay thresholds.",2021,The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib.,"['or 1 treatment with TARE according to their randomization arm', 'locally advanced and inoperable hepatocellular carcinoma', 'Locally Advanced and Inoperable Hepatocellular Carcinoma']","['SARAH (Sorafenib Versus Radioembolization', 'TARE', 'TARE versus sorafenib', 'transarterial radioembolization (TARE', 'sorafenib', 'radioembolization with yttrium-90 microspheres', 'continuous oral sorafenib', 'Transarterial Radioembolization With Yttrium-90 Resin Microspheres', 'Sorafenib']","['progression-free and overall survival, and quality of life', 'TARE', 'survival benefit', 'aerage cost', 'incremental cost-effectiveness ratio', 'life-years and quality-adjusted life-years (QALYs', 'toxicity profile']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C2985560', 'cui_str': 'Radioembolisation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C2985560', 'cui_str': 'Radioembolisation'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0303596', 'cui_str': 'Yttrium-90'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C2985560', 'cui_str': 'Radioembolisation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0696009,The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib.,"[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Zarca', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, DRCI-URC Eco Ile-de-France, Paris, France; Assistance Publique-Hôpitaux de Paris, service de santé publique, Henri Mondor-Albert-Chenevier, Créteil, France; Université de Paris, Research Centre of Research Epidemiology and Statistics (CRESS-UMR1153), Inserm, Paris, France. Electronic address: kevin.zarca@aphp.fr.'}, {'ForeName': 'Maroua', 'Initials': 'M', 'LastName': 'Mimouni', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, DRCI-URC Eco Ile-de-France, Paris, France.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Pereira', 'Affiliation': 'Université de Paris, CIC1418, INSERM, Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Unité de Recherche Clinique, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Chatellier', 'Affiliation': 'Université de Paris, CIC1418, INSERM, Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Unité de Recherche Clinique, Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Vilgrain', 'Affiliation': 'Université de Paris, CRI, INSERM U1149, Paris, France; Department of Radiology, Assistance Publique-Hôpitaux de Paris, University Hospitals Paris Nord Val de Seine, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, DRCI-URC Eco Ile-de-France, Paris, France; Assistance Publique-Hôpitaux de Paris, service de santé publique, Henri Mondor-Albert-Chenevier, Créteil, France; Université de Paris, Research Centre of Research Epidemiology and Statistics (CRESS-UMR1153), Inserm, Paris, France; UPEC, Creteil, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical therapeutics,['10.1016/j.clinthera.2021.04.018']
1288,34062589,[Update Psychocardiology].,"Psychocardiological research has contributed a better understanding of mental health, psychosocial factors and quality of life of in patients with cardiovascular diseases. In this update of psychocardiology in 2021, stressful experiences in childhood and adolescence are found to increase the risk of type II diabetes mellitus, coronary heart disease and stroke along the life course. Higher level of optimism, sense of purpose, and mindfulness can be possible protective factors for cardiovascular health. Summarizing the update of psychocardiological interventions, the effectiveness of team-based treatment (""blended collaborative care"") in secondary prevention is currently being tested in Germany in the randomized, controlled TEACH multicenter trial of patients with coronary heart disease and distress. Interventions such as positive psychology and mindfulness training can lead to a significant reduction in anxiety, stress and depression in heart patients.",2021,"Interventions such as positive psychology and mindfulness training can lead to a significant reduction in anxiety, stress and depression in heart patients.","['patients with coronary heart disease and distress', 'heart patients', 'patients with cardiovascular diseases']","['team-based treatment (""blended collaborative care', 'positive psychology and mindfulness training']","['anxiety, stress and depression', 'risk of type II diabetes mellitus, coronary heart disease and stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0264137,"Interventions such as positive psychology and mindfulness training can lead to a significant reduction in anxiety, stress and depression in heart patients.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sadlonova', 'Affiliation': 'Klinik für Psychosomatische Medizin und Psychotherapie, Universitätsmedizin Göttingen.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Herrmann-Lingen', 'Affiliation': 'Klinik für Psychosomatische Medizin und Psychotherapie, Universitätsmedizin Göttingen.'}]",Deutsche medizinische Wochenschrift (1946),['10.1055/a-1218-9204']
1289,34062587,[Lyme borreliosis and Lyme neuroborreliosis - an update].,"Lyme borreliosis is a tick-borne infectious disease caused by the spirochete bacterium Borrelia burgdorferi sensu lato. Lyme borreliosis is the most frequent zoonosis in Germany.Most cases show dermatological manifestations, like erythema migrans, followed by infections of the nervous system. Cerebrospinal fluid analysis should be performed if Lyme neuroborreliosis is suspected. Cell-based assays (like LTT or ELISPOT) should not be used when investigating Lyme disease.A recent randomized controlled trial showed a similar effect of doxycycline compared to betalactam-antibiotics regarding neurological symptoms in Lyme neuroborreliosis. This corroborates current German guideline recommendations.The prognosis of Lyme disease after antibiotic treatment is usually favorable. Frequency of fatigue, depression, impairments in quality of life and cognitive impairment are similar in patients after treatment of Lyme neuroborreliosis when compared to the general population.",2021,"Frequency of fatigue, depression, impairments in quality of life and cognitive impairment are similar in patients after treatment of Lyme neuroborreliosis when compared to the general population.",['Lyme neuroborreliosis'],"['Cell-based assays (like LTT or ELISPOT', 'betalactam-antibiotics', 'doxycycline']","['Frequency of fatigue, depression, impairments in quality of life and cognitive impairment']","[{'cui': 'C0752235', 'cui_str': 'Lyme neuroborreliosis'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",,0.107408,"Frequency of fatigue, depression, impairments in quality of life and cognitive impairment are similar in patients after treatment of Lyme neuroborreliosis when compared to the general population.","[{'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Dersch', 'Affiliation': 'Klinik für Neurologie und Neurophysiologie, Universitätsklinikum Freiburg, Medizinische Fakultät, Albert- Ludwigs-Universität Freiburg.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Fingerle', 'Affiliation': 'Nationales Referenzzentrum für Borrelien, Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Oberschleißheim.'}]",Deutsche medizinische Wochenschrift (1946),['10.1055/a-1265-4397']
1290,34074963,The Effect of the Neuman Systems Model on Anxiety in Patients Undergoing Coronary Artery Bypass Graft: A Randomized Controlled Trial.,"BACKGROUND


Coronary artery bypass graft (CABG) surgery is the most commonly used surgical procedure for patients with coronary artery disease. Anxiety is a significant psychological problem associated with CABG surgery that may reduce related treatment outcomes.
PURPOSE


This study was designed to investigate the effect on anxiety of applying the Neuman Systems Model in patients awaiting and undergoing CABG surgery.
METHODS


A single-blind, parallel-group randomized controlled trial was conducted on patients scheduled to receive coronary artery bypass surgery in an urban area of Iran. Seventy participants were enrolled using a convenience sampling method and randomly assigned to either the intervention group (n = 35) or the control group (n = 35). Participants in the intervention group received intervention in accordance with the Neuman Systems Model format, including meetings held at three levels of prevention. Patients' anxiety was measured using the State Anxiety Inventory before the intervention, immediately after the intervention, and at discharge time. The chi-square test, Fisher's exact test, independent sample t test, one-way repeated measures analysis of variance test, and Fisher's least significant difference were used to analyze the data.
RESULTS


No significant difference was found between the mean anxiety scores of the two groups before the intervention (p = .48, t = 0.71). However, the mean anxiety score of the intervention group was significantly lower than that of the control group immediately after the intervention (p = .008, t = 2.73) and at discharge time (p = .007, t = 2.77).
CONCLUSIONS


The Neuman-based program is an effective and low-cost intervention that may be applied to reduce anxiety in patients awaiting and undergoing CABG surgery. This program may be a good guide in providing healthcare services.",2021,The Neuman-based program is an effective and low-cost intervention that may be applied to reduce anxiety in patients awaiting and undergoing CABG surgery.,"['patients with coronary artery disease', 'in an urban area of Iran', 'Patients Undergoing Coronary Artery Bypass Graft', 'patients scheduled to receive', 'Seventy participants', 'patients awaiting and undergoing CABG surgery']","['Coronary artery bypass graft ', 'coronary artery bypass surgery', 'Neuman Systems Model']","['mean anxiety score', 'mean anxiety scores', 'State Anxiety Inventory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",70.0,0.0324226,The Neuman-based program is an effective and low-cost intervention that may be applied to reduce anxiety in patients awaiting and undergoing CABG surgery.,"[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Akhlaghi', 'Affiliation': 'RN, Doctoral Candidate, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Babaei', 'Affiliation': 'PhD, RN, Assistant Professor, Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mardani', 'Affiliation': 'RN, Doctoral Candidate, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Eskandari', 'Affiliation': 'PhD, RN, Support Worker, Psychiatric/Mental Health Nursing, Mental Health Community Making Life Better, Sydney, Australia.'}]",The journal of nursing research : JNR,['10.1097/JNR.0000000000000436']
1291,34073401,Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon.,"OBJECTIVE


This study was designed to determine the efficacy of ivermectin, an FDA-approved drug, in producing clinical benefits and decreasing the viral load of SARS-CoV-2 among asymptomatic subjects that tested positive for this virus in Lebanon.
METHODS


A randomized controlled trial was conducted in 100 asymptomatic Lebanese subjects that have tested positive for SARS-CoV2. Fifty patients received standard preventive treatment, mainly supplements, and the experimental group received a single dose (according to body weight) of ivermectin, in addition to the same supplements the control group received.
RESULTS


There was no significant difference ( p  = 0.06) between Ct-values of the two groups before the regimen was started (day zero), indicating that subjects in both groups had similar viral loads. At 72 h after the regimen started, the increase in Ct-values was dramatically higher in the ivermectin than in the control group. In the ivermectin group, Ct increased from 15.13 ± 2.07 (day zero) to 30.14 ± 6.22 (day three; mean ± SD), compared to the control group, where the Ct values increased only from 14.20 ± 2.48 (day zero) to 18.96 ± 3.26 (day three; mean ± SD). Moreover, more subjects in the control group developed clinical symptoms. Three individuals (6%) required hospitalization, compared to the ivermectin group (0%).
CONCLUSION


Ivermectin appears to be efficacious in providing clinical benefits in a randomized treatment of asymptomatic SARS-CoV-2-positive subjects, effectively resulting in fewer symptoms, lower viral load and reduced hospital admissions. However, larger-scale trials are warranted for this conclusion to be further cemented.",2021,"There was no significant difference ( p  = 0.06) between Ct-values of the two groups before the regimen was started (day zero), indicating that subjects in both groups had similar viral loads.","['asymptomatic subjects that tested positive for this virus in Lebanon', 'Asymptomatic SARS-CoV-2 Infected Subjects', '100 asymptomatic Lebanese subjects that have tested positive for SARS-CoV2', 'Fifty patients received']","['standard preventive treatment, mainly supplements', 'ivermectin, in addition to the same supplements the control group received', 'Ivermectin', 'ivermectin']","['Ct values', 'clinical symptoms', 'hospitalization', 'viral loads', 'Ct-values']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",100.0,0.200734,"There was no significant difference ( p  = 0.06) between Ct-values of the two groups before the regimen was started (day zero), indicating that subjects in both groups had similar viral loads.","[{'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'Samaha', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut P.O. Box 6573/14 Badaro, Lebanon.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Mouawia', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut P.O. Box 6573/14 Badaro, Lebanon.'}, {'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Fawaz', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Beirut Arab University, Beirut P.O. Box 115020, Lebanon.'}, {'ForeName': 'Hamad', 'Initials': 'H', 'LastName': 'Hassan', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut P.O. Box 6573/14 Badaro, Lebanon.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Salami', 'Affiliation': 'Department of Mathematics, Faculty of Sciences, Lebanese University, Nabatieh 1700, Lebanon.'}, {'ForeName': 'Ali Al', 'Initials': 'AA', 'LastName': 'Bazzal', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut P.O. Box 6573/14 Badaro, Lebanon.'}, {'ForeName': 'Hamid Bou', 'Initials': 'HB', 'LastName': 'Saab', 'Affiliation': 'Faculty of Sciences, Lebanese University, Zahle 1801, Lebanon.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Al-Wakeel', 'Affiliation': 'Karbala Health Directory, Baghdad 10081, Iraq.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alsaabi', 'Affiliation': 'Department of Biology, Lille University, 59160 Lille, France.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Chouman', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut P.O. Box 6573/14 Badaro, Lebanon.'}, {'ForeName': 'Mahmoud Al', 'Initials': 'MA', 'LastName': 'Moussawi', 'Affiliation': 'Faculty of Nursing Sciences, Islamic University of Lebanon, Baalbek 1800, Lebanon.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Ayoub', 'Affiliation': 'Department of Cardiology, Rayak University Hospital, Bekaa 1801, Lebanon.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Raad', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut P.O. Box 6573/14 Badaro, Lebanon.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Hajjeh', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut P.O. Box 6573/14 Badaro, Lebanon.'}, {'ForeName': 'Ali H', 'Initials': 'AH', 'LastName': 'Eid', 'Affiliation': 'Department of Basic Medical Sciences, College of Medicine, QU Health, Qatar University, Doha 00000, Qatar.'}, {'ForeName': 'Houssam', 'Initials': 'H', 'LastName': 'Raad', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut P.O. Box 6573/14 Badaro, Lebanon.'}]",Viruses,['10.3390/v13060989']
1292,34077237,Randomized Phase II Study of PET Response-Adapted Combined Modality Therapy for Esophageal Cancer: Mature Results of the CALGB 80803 (Alliance) Trial.,"PURPOSE


To evaluate the use of early assessment of chemotherapy responsiveness by positron emission tomography (PET) imaging to tailor therapy in patients with esophageal and esophagogastric junction adenocarcinoma.
METHODS


After baseline PET, patients were randomly assigned to an induction chemotherapy regimen: modified oxaliplatin, leucovorin, and fluorouracil (FOLFOX) or carboplatin-paclitaxel (CP). Repeat PET was performed after induction; change in maximum standardized uptake value (SUV) from baseline was assessed. PET nonresponders (< 35% decrease in SUV) crossed over to the alternative chemotherapy during chemoradiation (50.4 Gy/28 fractions). PET responders (≥ 35% decrease in SUV) continued on the same chemotherapy during chemoradiation. Patients underwent surgery at 6 weeks postchemoradiation. Primary end point was pathologic complete response (pCR) rate in nonresponders after switching chemotherapy.
RESULTS


Two hundred forty-one eligible patients received Protocol treatment, of whom 225 had an evaluable repeat PET. The pCR rates for PET nonresponders after induction FOLFOX who crossed over to CP (n = 39) or after induction CP who changed to FOLFOX (n = 50) was 18.0% (95% CI, 7.5 to 33.5) and 20% (95% CI, 10 to 33.7), respectively. The pCR rate in responders who received induction FOLFOX was 40.3% (95% CI, 28.9 to 52.5) and 14.1% (95% CI, 6.6 to 25.0) in responders to CP. With a median follow-up of 5.2 years, median overall survival was 48.8 months (95% CI, 33.2 months to not estimable) for PET responders and 27.4 months (95% CI, 19.4 months to not estimable) for nonresponders. For induction FOLFOX patients who were PET responders, median survival was not reached.
CONCLUSION


Early response assessment using PET imaging as a biomarker to individualize therapy for patients with esophageal and esophagogastric junction adenocarcinoma was effective, improving pCR rates in PET nonresponders. PET responders to induction FOLFOX who continued on FOLFOX during chemoradiation achieved a promising 5-year overall survival of 53%.",2021,PET responders to induction FOLFOX who continued on FOLFOX during chemoradiation achieved a promising 5-year overall survival of 53%.,"['Two hundred forty-one eligible patients received Protocol treatment, of whom 225 had an evaluable repeat PET', 'patients with esophageal and esophagogastric junction adenocarcinoma', 'Esophageal Cancer']","['induction FOLFOX', 'induction chemotherapy regimen: modified oxaliplatin, leucovorin, and fluorouracil (FOLFOX) or carboplatin-paclitaxel (CP', 'positron emission tomography (PET) imaging to tailor therapy', 'PET Response-Adapted Combined Modality Therapy', 'FOLFOX']","['maximum standardized uptake value (SUV', '5-year overall survival', 'pCR rate', 'SUV', 'median survival', 'pCR rates', 'pathologic complete response (pCR) rate', 'median overall survival']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",241.0,0.167795,PET responders to induction FOLFOX who continued on FOLFOX during chemoradiation achieved a promising 5-year overall survival of 53%.,"[{'ForeName': 'Karyn A', 'Initials': 'KA', 'LastName': 'Goodman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Nathan C', 'Initials': 'NC', 'LastName': 'Hall', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Tanios', 'Initials': 'T', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Mayo Clinic Cancer Center, Scottsdale, AZ.'}, {'ForeName': 'Briant', 'Initials': 'B', 'LastName': 'Fruth', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Twohy', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Meyers', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Boffa', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Kisha', 'Initials': 'K', 'LastName': 'Mitchell', 'Affiliation': 'Greenwich Hospital, Greenwich, CT.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Frankel', 'Affiliation': 'The Ohio State University Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Noonan', 'Affiliation': 'The Ohio State University Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'Yelena Y', 'Initials': 'YY', 'LastName': 'Janjigian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Thurmes', 'Affiliation': 'Metro Minnesota Community Oncology Research Consortium, Minneapolis, MN.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Dana Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.03611']
1293,34081897,Long-term cervical precancer outcomes after a negative DNA- or RNA-based human papillomavirus test result.,"BACKGROUND


Cervical cancer, a preventable disease associated with the human papillomavirus, is responsible for significant morbidity and mortality globally. Primary human papillomavirus testing is more sensitive in detecting precancerous cervical lesions than cytologic screening and can be conducted using either DNA- or RNA-based assays. Screening programs must select the most appropriate assay from several available assays for their population. It is not yet known whether these assays perform equivalently in the long term, particularly among women with a negative human papillomavirus test result. This study aims to compare long-term safety after a negative human papillomavirus test result across both DNA- and RNA-based testing assays.
OBJECTIVE


This study aimed to compare long-term high-grade cervical intraepithelial neoplasia (grade 2 or higher and grade 3 or higher) outcomes of 2 DNA-based assays (Digene Hybrid Capture 2 High-Risk HPV DNA Test and cobas 4800 HPV Test) and 1 messenger RNA-based assay (Aptima HPV Assay) using data from the Human Papillomavirus For Cervical Cancer Trial-DECADEl (FOCAL-DECADE) cohort, by first comparing the positive and negative rates between the assays and then investigating the cumulative incidence of cervical intraepithelial neoplasia grade 2 and higher and grade 3 or higher detection among participants in the FOCAL DECADE cohort over follow-up according to human papillomavirus testing assays.
STUDY DESIGN


The FOCAL Trial was a randomized controlled trial that evaluated human papillomavirus testing for primary cervical cancer screening. The FOCAL-DECADE cohort subsequently followed FOCAL Trial participants passively through the British Columbia Cervix Screening Program Database for approximately 10 years after the FOCAL Trial study exit to examine the rates of cervical intraepithelial neoplasia grade 2 or higher and grade 3 or higher. For this study, eligible participants had baseline human papillomavirus-negative results from at least 1 assay and had 1 or more cytologic screens after baseline (9509 participants for DNA-based and 3473 participants for DNA- vs RNA-based assay comparisons). We constructed cumulative incidence curves and compared the hazard ratios for cervical intraepithelial neoplasia grade 2 or higher and grade 3 or higher detection according to the assays.
RESULTS


Over 10 years of follow-up, the cumulative incidence of cervical intraepithelial neoplasia grade 2 or higher and grade 3 or higher did not significantly differ between the DNA-based assays (hazard ratio, 0.95; 95% confidence interval, 0.84-1.06; P=.35 and hazard ratio, 0.82; 95% confidence interval, 0.66-1.01; P=.06 for cervical intraepithelial neoplasia grade 2 or higher and cervical intraepithelial neoplasia grade 3 or higher, respectively) or between the DNA- and RNA-based assays (hazard ratio, 0.97; 95% confidence interval, 0.87-1.06; P=.48 and hazard ratio, 0.94; 95% confidence interval, 0.79-1.13; P=.52 for cervical intraepithelial neoplasia grade 2 or higher and cervical intraepithelial neoplasia grade 3 or higher, respectively).
CONCLUSION


Among participants who tested negative for human papillomavirus at baseline, the long-term risk of cervical intraepithelial neoplasia grade 2 or higher and grade 3 or higher did not significantly differ regardless of whether DNA- or RNA-based human papillomavirus testing assays were used. Screening program decision makers can be confident that for women who test negative for human papillomavirus, DNA- and RNA-based assays exhibit similar cervical intraepithelial neoplasia grade 2 or higher outcomes over several years.",2021,"Over ten years of follow-up, the cumulative incidence of CIN2+/CIN3+ did not significantly differ between the DNA-based assays (HR=0.95 (95% CI=0.84-1.06), p=0.35 and 0.82","['primary cervical cancer screening', 'eligible participants had baseline HPV negative results from at least one assay and had one or more cytology screens after baseline (N=9,509 for DNA-based and N=3,473 for DNA- versus RNA-based assay comparisons']","['RNA-based assay: Aptima HPV Assay', 'DNA-based assays']","['cumulative incidence of CIN2+ and CIN3+ detection', 'cumulative incidence of CIN2+/CIN3']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C4704700', 'cui_str': 'Null Results'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0851140', 'cui_str': 'Carcinoma in situ of uterine cervix'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",,0.0994097,"Over ten years of follow-up, the cumulative incidence of CIN2+/CIN3+ did not significantly differ between the DNA-based assays (HR=0.95 (95% CI=0.84-1.06), p=0.35 and 0.82","[{'ForeName': 'Talia H R', 'Initials': 'THR', 'LastName': 'Strang', 'Affiliation': ""Women's Health Research Institute, BC Women's Hospital and Health Service, Vancouver, British Columbia, Canada; Faculty of Health Sciences, Simon Fraser University, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gottschlich', 'Affiliation': ""Women's Health Research Institute, BC Women's Hospital and Health Service, Vancouver, British Columbia, Canada; Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Darrel A', 'Initials': 'DA', 'LastName': 'Cook', 'Affiliation': 'British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Laurie W', 'Initials': 'LW', 'LastName': 'Smith', 'Affiliation': ""Women's Health Research Institute, BC Women's Hospital and Health Service, Vancouver, British Columbia, Canada; Cancer Control Research, BC Cancer, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Lovedeep', 'Initials': 'L', 'LastName': 'Gondara', 'Affiliation': 'Cancer Surveillance and Outcomes, BC Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Franco', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Niekerk', 'Affiliation': 'Cervix Screening Program, BC Cancer, Vancouver, British Columbia, Canada; Lower Mainland Laboratories, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Gina S', 'Initials': 'GS', 'LastName': 'Ogilvie', 'Affiliation': ""Women's Health Research Institute, BC Women's Hospital and Health Service, Vancouver, British Columbia, Canada; Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Krajden', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada; Lower Mainland Laboratories, Vancouver, British Columbia, Canada. Electronic address: mel.krajden@bccdc.ca.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.05.038']
1294,34086067,"A phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX04 to reference bevacizumab sourced from the United States, the European Union, and China in healthy Chinese male volunteers.","PURPOSE


To compare the pharmacokinetic profiles, safety and immunogenicity of proposed bevacizumab biosimilar HLX04 with reference bevacizumab in healthy Chinese males.
METHODS


In this double-blind Phase 1 study, healthy volunteers (N = 208) were randomized 1:1:1:1 to a single 3 mg/kg intravenous infusion of HLX04 or reference bevacizumab sourced from the United States (bevacizumab-US), the European Union (bevacizumab-EU) or China (bevacizumab-CN). Co-primary endpoints were area under the serum concentration-time profile (AUC) from time zero extrapolated to infinity (AUC 0-inf ) and from zero to last quantifiable concentration (AUC last ). Secondary endpoint was the maximum serum drug concentration (C max ). Study participants were monitored for treatment-emergent adverse events (TEAEs) and samples were collected for anti-drug antibody (ADA) testing throughout the study.
RESULTS


Pharmacokinetic parameters were similar across groups. The respective geometric least-squares mean ratios (GLSMR) of AUC 0-inf , AUC last  and C max  were: 95.7%, 96.0% and 101.8% for HLX04 versus bevacizumab-US; 94.3%, 94.6% and 100.5% for HLX04 versus bevacizumab-EU; and 90.0%, 90.4% and 98.2% for HLX04 versus bevacizumab-CN. For all test-to-reference comparisons, two-sided 90% confidence intervals of GLSMR for AUC 0-inf , AUC last  and C max  fell in the pre-specified bioequivalence range (80-125%). There were no notable differences in the frequency, nature and/or grade of TEAEs. No deaths were reported and no ADAs were detected during the study.
CONCLUSION


HLX04 had similar safety and pharmacokinetic profiles to reference bevacizumab in healthy Chinese males, supporting the confirmatory Phase 3 study investigating the efficacy and safety equivalence between HLX04 and bevacizumab in patients with metastatic colorectal cancer (NCT03511963).
CLINICAL TRIAL REGISTRATION


The study was registered with Clinicaltrials.gov, NCT03483649.",2021,AUC last  and C max  fell in the pre-specified bioequivalence range (80-125%).,"['healthy volunteers (N\u2009=\u2009208', 'patients with metastatic colorectal cancer (NCT03511963', 'healthy Chinese males', 'healthy Chinese male volunteers']","['HLX04', 'bevacizumab-CN', 'HLX04 and bevacizumab', 'bevacizumab', 'HLX04 to reference bevacizumab', 'bevacizumab-EU', 'HLX04 or reference bevacizumab sourced from the United States (bevacizumab-US), the European Union (bevacizumab-EU) or China (bevacizumab-CN', 'bevacizumab biosimilar HLX04 with reference bevacizumab']","['AUC last  and C max  fell', 'frequency, nature and/or grade of TEAEs', 'safety and pharmacokinetic profiles', 'respective geometric least-squares mean ratios (GLSMR) of AUC 0-inf , AUC last  and C max', 'area under the serum concentration-time profile (AUC) from time zero extrapolated to infinity (AUC 0-inf ) and from zero to last quantifiable concentration (AUC last ', 'pharmacokinetic profiles, safety and immunogenicity', 'maximum serum drug concentration (C max ', 'efficacy and safety equivalence']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",208.0,0.102627,AUC last  and C max  fell in the pre-specified bioequivalence range (80-125%).,"[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'The First Hospital of Jilin University, No. 1 Xinmin Street, Chaoyang District, Changchun, Jilin, China.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Qian', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Jixuan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'The First Hospital of Jilin University, No. 1 Xinmin Street, Chaoyang District, Changchun, Jilin, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'The First Hospital of Jilin University, No. 1 Xinmin Street, Chaoyang District, Changchun, Jilin, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'The First Hospital of Jilin University, No. 1 Xinmin Street, Chaoyang District, Changchun, Jilin, China.'}, {'ForeName': 'Xiaodi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Chai', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, No. 1 Xinmin Street, Chaoyang District, Changchun, Jilin, China. xiaojiaoli@jlu.edu.cn.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-021-04297-z']
1295,34014324,Effect of Community Health Workers on 30-Day Hospital Readmissions in an Accountable Care Organization Population: A Randomized Clinical Trial.,"Importance


Value-based care within accountable care organizations (ACOs) has magnified the importance of reducing preventable hospital readmissions. Community health worker (CHW) interventions may address patients' unmet psychosocial and clinical care needs but have been underused in inpatient and postdischarge care.
Objective


To determine if pairing hospitalized patients with ACO insurance with CHWs would reduce 30-day readmission rates.
Design, Setting, and Participants


This randomized clinical trial was conducted in 6 general medicine hospital units within 1 academic medical center in Boston, Massachusetts. Participants included adults hospitalized from April 1, 2017, through March 31, 2019, who had ACO insurance and were at risk for 30-day readmission based on a hospital readmission algorithm. The main inclusion criterion was frequency of prior nonelective hospitalizations (≥2 in the past 3 months or ≥3 in the 12 months prior to enrollment). Data were analyzed from February 1, 2018, through March 3, 2021.
Intervention


CHWs met with intervention participants prior to discharge and maintained contact for 30 days postdischarge to assist participants with clinical access and social resources via telephone calls, text messages, and field visits. CHWs additionally provided psychosocial support and health coaching, using motivational interviewing, goal-setting, and other behavioral strategies. The control group received usual care, which included routine care from primary care clinics and any outpatient referrals made by hospital case management or social work at the time of discharge.
Main Outcomes and Measures


The primary outcome was 30-day hospital readmissions. Secondary outcomes included 30-day missed primary care physician or specialty appointments.
Results


A total of 573 participants were enrolled, and 550 participants (mean [SD] age, 70.1 [15.7] years; 266 [48.4%] women) were included in analysis, with 277 participants randomized to the intervention group and 273 participants randomized to the control group. At baseline, participants had a mean (SD) of 3 (0.8) hospitalizations in the prior 12 months. There were 432 participants (78.5%) discharged home and 127 participants (23.1%) discharged to a short rehabilitation stay prior to returning home. Compared with participants in the control group, participants in the intervention group were less likely to be readmitted within 30 days (odds ratio [OR], 0.44; 95% CI, 0.28-0.90) and to miss clinic appointments within 30 days (OR, 0.56; 95% CI, 0.38-0.81). A post hoc subgroup analysis showed that compared with control participants, intervention participants discharged to rehabilitation had a reduction in readmissions (OR, 0.09; 95% CI, 0.03-0.31), but there was no significant reduction for those discharged home (OR, 0.68; 95% CI, 0.41-1.12).
Conclusions and Relevance


This randomized clinical trial found that pairing ACO-insured inpatient adults with CHWs reduced readmissions and missed outpatient visits 30 days postdischarge. The effect was significant for those discharged to short-term rehabilitation but not for those discharged home.
Trial Registration


ClinicalTrials.gov Identifier: NCT03085264.",2021,"A post hoc subgroup analysis showed that compared with control participants, intervention participants discharged to rehabilitation had a reduction in readmissions (OR, 0.09; 95% CI, 0.03-0.31), but there was no significant reduction for those discharged home (OR, 0.68; 95% CI, 0.41-1.12).
","['Participants included adults hospitalized from April 1, 2017, through March 31, 2019, who had ACO insurance and were at risk for 30-day readmission based on a hospital readmission algorithm', '432 participants (78.5%) discharged home and 127 participants (23.1%) discharged to a short rehabilitation stay prior to returning home', 'pairing hospitalized patients with ACO insurance with', 'pairing ACO-insured inpatient adults with CHWs reduced readmissions and missed outpatient visits 30 days postdischarge', '6 general medicine hospital units within 1 academic medical center in Boston, Massachusetts', '573 participants were enrolled, and 550 participants (mean [SD] age, 70.1 [15.7] years; 266 [48.4%] women) were included in analysis, with 277 participants randomized to the intervention group and 273 participants randomized to the control group', 'Accountable Care Organization Population']","['Community health worker (CHW) interventions', 'usual care, which included routine care from primary care clinics and any outpatient referrals made by hospital case management or social work at the time of discharge', 'CHWs', 'Community Health Workers']","['readmissions', 'frequency of prior nonelective hospitalizations', '30-day missed primary care physician or specialty appointments', '30-day readmission rates', '30-day hospital readmissions', '30-Day Hospital Readmissions']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0579192', 'cui_str': 'Returned home'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0019988', 'cui_str': 'Hospital Units'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3179030', 'cui_str': 'Accountable Care Organization'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}]",573.0,0.390478,"A post hoc subgroup analysis showed that compared with control participants, intervention participants discharged to rehabilitation had a reduction in readmissions (OR, 0.09; 95% CI, 0.03-0.31), but there was no significant reduction for those discharged home (OR, 0.68; 95% CI, 0.41-1.12).
","[{'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Walton', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Liyang', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Donelan', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.10936']
1296,34018430,A Radio Drama's Effects on HIV Attitudes and Policy Priorities: A Field Experiment in Tanzania.,"A growing body of evidence investigates how entertainment education influences knowledge about HIV, stigma toward those with HIV, and openness to disclosing one's HIV status. The present study shows that in addition to these effects, mass media interventions may influence audiences' policy priorities, such as their demand for local access to HIV/AIDS medical care. A condensed (2 hours) version of a popular Swahili radio drama was presented to rural Tanzanians as part of a placebo-controlled experiment, clustered at the village level. A random sample comprising 1,200 participants were interviewed at baseline and invited to attend a presentation of the radio drama, and 83% attended. Baseline respondents were reinterviewed 2 weeks later with a response rate of 95%. In addition to increasing listeners' knowledge and support for disclosure of HIV status, the radio drama produced sizable and statistically significant effects on listeners' preference for hypothetical candidates promising improved HIV/AIDS treatment.",2021,"A condensed (2 hours) version of a popular Swahili radio drama was presented to rural Tanzanians as part of a placebo-controlled experiment, clustered at the village level.","['1,200 participants were interviewed at baseline and invited to attend a presentation of the radio drama, and 83% attended', 'Tanzania']",[],"['HIV Attitudes and Policy Priorities', ""listeners' preference""]","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0013109', 'cui_str': 'Drama'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]",1200.0,0.0991281,"A condensed (2 hours) version of a popular Swahili radio drama was presented to rural Tanzanians as part of a placebo-controlled experiment, clustered at the village level.","[{'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Green', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Dylan W', 'Initials': 'DW', 'LastName': 'Groves', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Manda', 'Affiliation': 'Yale University, New Haven, CT, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/10901981211010421']
1297,34021353,Protecting Children From Tobacco Smoke Exposure: A Randomized Controlled Trial of Project Zero Exposure.,"INTRODUCTION


Young children are vulnerable to harm from tobacco smoke exposure (TSE). This study assessed the effect of Project Zero Exposure-an intervention program designed to help parents protect children from TSE-on children's exposure.
METHODS


Randomized controlled trial of a home-based, theory-driven intervention. Parents of young children (<8 y) in families with a smoking parent were eligible. The intervention included feedback on child TSE (hair nicotine), and home air quality (PM2.5), with motivational interviewing. Families were randomized to: intervention group (IG, N = 69), regular control group (RCG, N = 70), or to a secondary enhanced control group, (ECG, N = 20). Child hair samples were taken at baseline and follow-up. We report on child TSE in the IG versus RCG at six months.
RESULTS


Most enrolled families completed the trial (IG: 98.6%[68/69], RCG: 97.1%[68/70]). Log hair nicotine (LHN [ng/mg]) decreased in both the IG (Baseline: -1.78 ± 1.91, Follow-up: -2.82 ± 1.87, p = .003) and RCG (Baseline: -1.79 ± 1.54, Follow-up: -2.85 ± 1.73, p = .002), but did not differ between groups at study end (p = .635). Three of five parentally-reported outcomes showed improvement over time in the IG, and one in the RCG. Among IG participants, 90% found hair nicotine feedback useful.
CONCLUSIONS


No difference between the intervention and control groups was found on the objective biomarker, LHN. Child TSE decreased during the trial in intervention and control groups. Trial participation, which included hair nicotine monitoring, may have contributed to decreasing exposure in both groups. Concurrent control group improvements may partially explain lack of proven intervention benefit. Biomarker monitoring warrants further investigation for reduction of child TSE.
IMPLICATIONS


Project Zero Exposure is an intervention program designed to help parents protect their children from TSE. Results from the randomized controlled trial of the program showed no difference between groups at study end, but a clear and substantial reduction in child exposure to tobacco smoke from beginning to end of the trial, in both intervention and control groups. Biomarker monitoring, a key element of the trial, was used with all participants. Biomarker monitoring of child exposure to tobacco smoke may help parents become aware of their child's exposure and better protect them, and should be explored as a means to reduce child TSE. Clinical Trial Registration: NCT02867241.",2021,"No difference between the intervention and control groups was found on the objective biomarker, LHN.","['Protecting children from tobacco smoke exposure', 'Parents of young children (< 8 years) in families with a smoking parent were eligible', ""parents protect children from TSE - on children's exposure""]","['LHN', 'regular control group (RCG, N=70), or to a secondary enhanced control group', 'Project Zero Exposure - an intervention program', 'intervention included feedback on child TSE (hair nicotine), and home air quality (PM2.5), with motivational interviewing']","['objective biomarker, LHN', 'Child tobacco smoke exposure', 'hair nicotine feedback useful']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.0975728,"No difference between the intervention and control groups was found on the objective biomarker, LHN.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rosen', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zucker', 'Affiliation': 'Department of Statistics, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Nurit', 'Initials': 'N', 'LastName': 'Guttman', 'Affiliation': 'Department of Communications, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Bitan', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rule', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Mati', 'Initials': 'M', 'LastName': 'Berkovitch', 'Affiliation': ""Assaf Harofeh Medical Center, Be'er Ya'akov, Israel.""}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Myers', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab106']
1298,34019431,Secondary Cytoreduction and Carboplatin Hyperthermic Intraperitoneal Chemotherapy for Platinum-Sensitive Recurrent Ovarian Cancer: An MSK Team Ovary Phase II Study.,"PURPOSE


The purpose of this phase II study was to evaluate hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin for recurrent ovarian cancer during secondary cytoreductive surgery.
MATERIALS AND METHODS


Patients were intraoperatively randomly assigned to carboplatin HIPEC (800 mg/m 2  for 90 minutes) or no HIPEC, followed by five or six cycles of postoperative IV carboplatin-based chemotherapy, respectively. Based on a binomial single-stage pick-the-winner design, an arm was considered winner if ≥ 17 of 49 patients were without disease progression at 24 months post-surgery. Secondary objectives included postoperative toxicity and HIPEC pharmacokinetics.
RESULTS


Of 98 patients, 49 (50%) received HIPEC. Complete gross resection was achieved in 82% of the HIPEC patients and 94% of the standard-arm patients. Bowel resection was performed in 37% of patients in the HIPEC arm compared with 65% in the standard ( P  = .008). There was no perioperative mortality and no difference in use of ostomies, length of stay, or postoperative toxicity. At 24 months, eight patients (16.3%; 1-sided 90% CI, 9.7 to 100) were without progression or death in the HIPEC arm and 12 (24.5%; 1-sided 90% CI, 16.5 to 100) in the standard arm. With a medium follow-up of 39.5 months, 82 patients progressed and 37 died. The median progression-free survival in the HIPEC and standard arms were 12.3 and 15.7 months, respectively (hazard ratio, 1.54; 95% CI, 1 to 2.37;  P  = .05). There was no significant difference in median overall survival (52.5  v  59.7 months, respectively; hazard ratio, 1.39; 95% CI, 0.73 to 2.67;  P  = .31). These analyses were exploratory.
CONCLUSION


HIPEC with carboplatin was well tolerated but did not result in superior clinical outcomes. This study does not support the use of HIPEC with carboplatin during secondary cytoreductive surgery for platinum-sensitive recurrent ovarian cancer.",2021,Bowel resection was performed in 37% of patients in the HIPEC arm compared with 65% in the standard ( P  = .008).,"['Patients', 'recurrent ovarian cancer during secondary cytoreductive surgery', 'platinum-sensitive recurrent ovarian cancer', 'Platinum-Sensitive Recurrent Ovarian Cancer']","['carboplatin HIPEC', 'Carboplatin Hyperthermic Intraperitoneal Chemotherapy', 'no HIPEC, followed by five or six cycles of postoperative IV carboplatin-based chemotherapy', 'hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin', 'HIPEC with carboplatin', 'HIPEC']","['median progression-free survival', 'postoperative toxicity and HIPEC pharmacokinetics', 'Bowel resection', 'Complete gross resection', 'perioperative mortality', 'progression or death', 'median overall survival', 'ostomies, length of stay, or postoperative toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0029473', 'cui_str': 'Construction of stoma'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.232662,Bowel resection was performed in 37% of patients in the HIPEC arm compared with 65% in the standard ( P  = .008).,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Chi', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Iasonos', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Konner', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Makker', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Grisham', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Brown', 'Affiliation': 'Hartford Healthcare Cancer Institute, Hartford, CT.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Nerenstone', 'Affiliation': 'Hartford Healthcare Cancer Institute, Hartford, CT.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Diaz', 'Affiliation': 'Miami Cancer Institute, Miami, FL.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Schroeder', 'Affiliation': 'Miami Cancer Institute, Miami, FL.'}, {'ForeName': 'Carrie L', 'Initials': 'CL', 'LastName': 'Langstraat', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Viktoriya', 'Initials': 'V', 'LastName': 'Paroder', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Lakhman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Krysten', 'Initials': 'K', 'LastName': 'Soldan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Su', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Ginger J', 'Initials': 'GJ', 'LastName': 'Gardner', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Vaagn', 'Initials': 'V', 'LastName': 'Andikyan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Jianxia', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Jewell', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Long Roche', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Troso-Sandoval', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Lichtman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Lea A', 'Initials': 'LA', 'LastName': 'Moukarzel', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Dessources', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Nadeem R', 'Initials': 'NR', 'LastName': 'Abu-Rustum', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Tew', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beumer', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Sonoda', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Roisin E', 'Initials': 'RE', 'LastName': ""O'Cearbhaill"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.00605']
1299,34389170,Lifting the lid on perioperative goal-directed therapy.,The complex cellular interactions that underlie pathologies related to reduced oxygen delivery after surgery are poorly defined and difficult to measure. Heywood and colleagues explored the patterns of protein expression in skin biopsies taken from a subgroup of patients enrolled in a randomised trial designed to evaluate perioperative goal-directed therapy. One of their key findings was that a failure of participants to maintain preoperative systemic oxygen delivery was associated with an upregulation of intracellular proteins involved in counteracting oxidative stress. Their study highlights the importance of oxidative stress in the perioperative setting and suggests that maintenance of baseline oxygen delivery might be an important regulator of redox balance.,2021,One of their key findings was that a failure of participants to maintain preoperative systemic oxygen delivery was associated with an upregulation of intracellular proteins involved in counteracting oxidative stress.,[],[],[],[],[],[],,0.18048,One of their key findings was that a failure of participants to maintain preoperative systemic oxygen delivery was associated with an upregulation of intracellular proteins involved in counteracting oxidative stress.,"[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Martin', 'Affiliation': 'Peninsula Medical School, University of Plymouth, Plymouth, UK. Electronic address: daniel.martin@plymouth.ac.uk.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.07.009']
1300,34389168,Goal-directed fluid therapy in emergency abdominal surgery: a randomised multicentre trial.,"BACKGROUND


More than 50% of patients have a major complication after emergency gastrointestinal surgery. Intravenous (i.v.) fluid therapy is a life-saving part of treatment, but evidence to guide what i.v. fluid strategy results in the best outcome is lacking. We hypothesised that goal-directed fluid therapy during surgery (GDT group) reduces the risk of major complications or death in patients undergoing major emergency gastrointestinal surgery compared with standard i.v. fluid therapy (STD group).
METHODS


In a randomised, assessor-blinded, two-arm, multicentre trial, we included 312 adult patients with gastrointestinal obstruction or perforation. Patients in the GDT group received i.v. fluid to near-maximal stroke volume. Patients in the STD group received i.v. fluid following best clinical practice. Postoperative target was 0-2 L fluid balance. The primary outcome was a composite of major complications or death within 90 days. Secondary outcomes were time in intensive care, time on ventilator, time in dialysis, hospital stay, and minor complications.
RESULTS


In a modified intention-to-treat analysis, we found no difference in the primary outcome between groups: 45 (30%) (GDT group) vs 39 (25%) (STD group) (odds ratio=1.24; 95% confidence interval, 0.75-2.05; P=0.40). Hospital stay was longer in the GDT group: median (inter-quartile range), 7 (4-12) vs 6 days (4-8.5) (P=0.04); no other differences were found.
CONCLUSION


Compared with pressure-guided i.v. fluid therapy (STD group), flow-guided fluid therapy to near-maximal stroke volume (GDT group) did not improve the outcome after surgery for bowel obstruction or gastrointestinal perforation but may have prolonged hospital stay.
CLINICAL TRIAL REGISTRATION


EudraCT number 2015-000563-14; the Danish Scientific Ethics Committee and the Danish Data Protection Agency (REG-18-2015).",2021,"Hospital stay was longer in the GDT group: median (inter-quartile range), 7 (4-12) vs 6 days (4-8.5) (P=0.04); no other differences were found.
","['312 adult patients with gastrointestinal obstruction or perforation', 'patients undergoing major emergency gastrointestinal surgery', 'emergency abdominal surgery']","['Goal-directed fluid therapy', 'goal-directed fluid therapy during surgery (GDT group', 'fluid therapy (STD group), flow-guided fluid therapy to near-maximal stroke volume (GDT group', 'GDT', 'Intravenous (i.v.) fluid therapy']","['risk of major complications or death', 'Hospital stay', 'composite of major complications or death within 90 days', 'time in intensive care, time on ventilator, time in dialysis, hospital stay, and minor complications']","[{'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0236124', 'cui_str': 'Gastrointestinal obstruction'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2603364', 'cui_str': 'On ventilator'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",312.0,0.659272,"Hospital stay was longer in the GDT group: median (inter-quartile range), 7 (4-12) vs 6 days (4-8.5) (P=0.04); no other differences were found.
","[{'ForeName': 'Anne A', 'Initials': 'AA', 'LastName': 'Aaen', 'Affiliation': 'Department of Anaesthesia, Holbæk Hospital, Part of Copenhagen University Hospitals, Holbaek, Denmark. Electronic address: aaaa@regionsjaelland.dk.'}, {'ForeName': 'Anders W', 'Initials': 'AW', 'LastName': 'Voldby', 'Affiliation': 'Department of Surgery, Holbæk Hospital, Part of Copenhagen University Hospitals, Holbaek, Denmark.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Storm', 'Affiliation': 'Department of Surgery, Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'Jeppe', 'Initials': 'J', 'LastName': 'Kildsig', 'Affiliation': 'Department of Surgery, Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'Egon G', 'Initials': 'EG', 'LastName': 'Hansen', 'Affiliation': 'Department of Anaesthesia, Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Zimmermann-Nielsen', 'Affiliation': 'Department of Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Jensen', 'Affiliation': 'Department of Anaesthesia, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Tibæk', 'Affiliation': 'Department of Surgery, Slagelse Hospital, Part of Copenhagen University Hospitals, Slagelse, Zealand, Denmark.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Mortensen', 'Affiliation': 'Department of Anaesthesia, Slagelse Hospital, Part of Copenhagen University Hospitals, Slagelse, Zealand, Denmark.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Møller', 'Affiliation': 'Department of Anaesthesia, Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Brandstrup', 'Affiliation': 'Department of Surgery, Holbæk Hospital, Part of Copenhagen University Hospitals, Holbaek, Denmark.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.06.031']
1301,34042178,Does learning to code influence cognitive skills of elementary school children? Findings from a randomized experiment.,"BACKGROUND


Coding has been added to school curricula in several countries, being one of the necessary competencies of the 21st century. Although it has also been suggested to foster the development of several cognitive skills such as computational thinking and problem-solving, studies on the effects of coding are very limited, provide mixed results, and lack causal evidence.
AIM


This study aims to evaluate the impact of a learn-to-code programme on three cognitive skills in children: computational thinking, fluid intelligence, and spatial orientation, using a randomized trial.
SAMPLE


One hundred seventy-four (n = 81 girls) 4th-grade children participated in the study.
METHODS


Children were randomly assigned to one of the three 10-week learning programmes: learn-to-code (treatment of interest), mathematics (another STEM-related comparison treatment), and reading (control). Children responded to paper-pencil computational thinking, and spatial orientation measurements, and face-to-face matrix reasoning task at pre- and post-tests.
RESULTS


Results showed that children's computational thinking scores increased significantly only in the learn-to-code condition. Fluid intelligence significantly increased in all conditions, possibly due to a practice effect. The spatial orientation did not improve in any of the conditions.
CONCLUSION


These findings suggested that learning to code can be selectively beneficial for the development of computational thinking skills while not effective for spatial reasoning and fluid intelligence.",2021,"The spatial orientation did not improve in any of the conditions.
","['children', 'One hundred seventy-four (n\xa0=\xa081 girls', '4th-grade children participated in the study', 'elementary school children', 'Children']","['learn-to-code programme', 'learning programmes: learn-to-code (treatment of interest), mathematics (another STEM-related comparison treatment), and reading (control']","['computational thinking scores', 'Fluid intelligence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}]",174.0,0.0670202,"The spatial orientation did not improve in any of the conditions.
","[{'ForeName': 'Meryem Şeyda', 'Initials': 'MŞ', 'LastName': 'Özcan', 'Affiliation': 'Department of Psychology, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Çetinkaya', 'Affiliation': 'Department of Psychology, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Tilbe', 'Initials': 'T', 'LastName': 'Göksun', 'Affiliation': 'Department of Psychology, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Kisbu-Sakarya', 'Affiliation': 'Department of Psychology, Koç University, Istanbul, Turkey.'}]",The British journal of educational psychology,['10.1111/bjep.12429']
1302,34041713,Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog ®  Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data.,"BACKGROUND AND OBJECTIVE


Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This pooled analysis compared the pharmacokinetics and glucodynamics between URLi and Humalog ®  in healthy subjects and patients with type 1 or type 2 diabetes mellitus.
METHODS


The analysis included four randomized, double-blind, crossover, single-dose studies (healthy subjects [n = 74], patients with type 1 diabetes [n = 78], and type 2 diabetes [n = 38]) evaluating subcutaneous doses of 7, 15, or 30 U of URLi and Humalog during an 8- to 10-h euglycemic clamp procedure.
RESULTS


The pooled analysis showed an ~ 5-min faster onset of appearance, an ~8-fold greater exposure in the first 15 min, a 43% reduction in exposure beyond 3 h, and a 68-min shorter exposure duration with URLi vs Humalog across all study populations and dose range. Compared with Humalog, URLi had a 10-min faster onset of action, a 3-fold greater insulin action in the first 30 min, a 35% reduction in insulin action beyond 4 h, and a 44-min shorter duration of action across all populations and dose range. Overall exposure and insulin action were similar between URLi and Humalog for each dose level and study population.
CONCLUSIONS


Across the studied populations and dose range, URLi consistently demonstrated a faster absorption, reduced late exposure, and overall shorter exposure duration compared with Humalog. Similarly, URLi demonstrated earlier insulin action while reducing late insulin action and shorter insulin action compared with Humalog across the study populations and dose range.
CLINICAL TRIAL REGISTRATION


NCT02942654 (registered: 21 October, 2016), NCT03286751 (registered: 15 September, 2017), NCT03166124 (registered: 23 May, 2017), and NCT03305822 (registered: 5 October, 2017).",2021,"Across the studied populations and dose range, URLi consistently demonstrated a faster absorption, reduced late exposure, and overall shorter exposure duration compared with Humalog.","['healthy subjects and patients with type 1 or type 2 diabetes mellitus', 'Across Study Populations', 'healthy subjects [n = 74], patients with type 1 diabetes [n = 78], and type 2 diabetes [n = 38']","['Ultra Rapid Lispro (URLi', 'Humalog, URLi', 'evaluating subcutaneous doses of 7, 15, or 30 U of URLi and Humalog during an 8- to 10-h euglycemic clamp procedure']","['insulin action', 'late insulin action and shorter insulin action', 'Overall exposure and insulin action']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.137667,"Across the studied populations and dose range, URLi consistently demonstrated a faster absorption, reduced late exposure, and overall shorter exposure duration compared with Humalog.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. leohr_jennifer_k@lilly.com.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Kallin', 'Initials': 'K', 'LastName': 'Carter', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-021-01030-0']
1303,34044366,Dose-Response Relationship Between Velocity Loss During Resistance Training and Changes in the Squat Force-Velocity Relationship.,"PURPOSE


This study aimed to compare the adaptations provoked by various velocity loss (VL) thresholds used in resistance training on the squat force-velocity (F-V) relationship.
METHODS


Sixty-four resistance-trained young men were randomly assigned to one of four 8-week resistance training programs (all 70%-85% 1-repetition maximum) using different VL thresholds (VL0 = 0%, VL10 = 10%, VL20 = 20%, and VL40 = 40%) in the squat exercise. The F-V relationship was assessed under unloaded and loaded conditions in squat. Linear and hyperbolic (Hill) F-V equations were used to calculate force at zero velocity (F0), velocity at zero force (V0), maximum muscle power (Pmax), and force produced at mean velocities ranging from 0.0 to 2.0 m·s-1. Changes in parameters derived from the F-V relationship were compared among groups using linear mixed models.
RESULTS


Linear equations showed increases in F0 (120.7 N [89.4 to 152.1]) and Pmax (76.2 W [45.3 to 107.2]) and no changes in V0 (-0.02 m·s-1 [-0.11 to 0.06]) regardless of VL. Hyperbolic equations depicted increases in F0 (120.7 N [89.4 to 152.1]), V0 (1.13 m·s-1 [0.78 to 1.48]), and Pmax (198.5 W [160.5 to 236.6]) with changes in V0 being greater in VL0 and VL10 versus VL40 (both P < .001). All groups similarly improved force at 0.0 to 2.0 m·s-1 (all P < .001), although in general, effect sizes were greater in VL10 and VL20 versus VL0 and VL40 at velocities ≤0.5 m·s-1.
CONCLUSIONS


All groups improved linear and hyperbolic F0 and Pmax and hyperbolic V0 (except VL40). The dose-response relationship exhibited an inverted U-shape pattern at velocities ≤0.5 m·s-1 with VL10 and VL20 showing the greatest standardized changes.",2021,The dose-response relationship exhibited an inverted U-shape pattern at velocities ≤0.5 m·s-1 with VL10 and VL20 showing the greatest standardized changes.,['Sixty-four resistance-trained young men'],['squat exercise'],"['calculate force at zero velocity (F0), velocity at zero force (V0), maximum muscle power (Pmax), and force produced at mean velocities', 'VL10 and VL20 versus VL0 and VL40 at velocities ≤0.5', 'linear and hyperbolic F0 and Pmax and hyperbolic V0 (except VL40', 'Velocity Loss', 'F0', 'Linear and hyperbolic (Hill) F-V equations']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",64.0,0.0297932,The dose-response relationship exhibited an inverted U-shape pattern at velocities ≤0.5 m·s-1 with VL10 and VL20 showing the greatest standardized changes.,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Alcazar', 'Affiliation': ''}, {'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Cornejo-Daza', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sánchez-Valdepeñas', 'Affiliation': ''}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Alegre', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pareja-Blanco', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0692']
1304,34044355,[I-Gel® laryngeal mask versus bag-valve-mask in instrumental cardiopulmonary resuscitation under capnographic monitoring: Cluster-randomized pilot clinical trial].,"OBJECTIVE


To compare the basic airway and the advanced airway with the supraglottic device I-Gel®, by means of capnography during intermediate CPR.
DESIGN


Randomized experimental pilot study by groups.
SETTING


Out-hospital care basic life support units on the Island of Mallorca.
PARTICIPANTS


Adults attended after cardiorespiratory arrest of non-traumatic origin.
INTERVENTIONS


Advanced airway management during instrumental CPR with I-Gel® or basic CPR with bag-valve-mask, under capnographic monitoring.
MAIN MEASUREMENTS


Capnometric levels obtained according to the device used, number of insertions of the I-Gel®, cases without achieving correct insertion/ventilation by branches, achievement of ROSC in CPR and number of hospital live admissions.
RESULTS


Twenty-three cases were recruited for analysis. The insertion success rate of the I-Gel® was 92.9% at the first attempt, the mean capnometric values were 16.3mmHg in the control group and 27.4% in the intervention group. 34.8% (n=8) of the patients achieved spontaneous circulation recovery at some point and 26.1% (n=6) were admitted to hospital alive. The survival analysis, taking into account the arrival of the unit and the first minute of ventilations recorded together with the variable hospital admission, suggests a certain trend of greater survival in the intervention branch (P=.066).
CONCLUSIONS


The use of I-Gel® raises an improvement in the ventilation of the patients in PCR, evidenced by the mean capnometric values in the intervention group, finding no correlation with CPR outcome variables.",2021,"The insertion success rate of the I-Gel® was 92.9% at the first attempt, the mean capnometric values were 16.3mmHg in the control group and 27.4% in the intervention group.","['Out-hospital care basic life support units on the Island of Mallorca', 'Adults attended after cardiorespiratory arrest of non-traumatic origin', 'Twenty-three cases were recruited for analysis']",['Gel® laryngeal mask versus bag-valve-mask'],"['Capnometric levels obtained according to the device used, number of insertions of the I-Gel®, cases without achieving correct insertion/ventilation by branches, achievement of ROSC in CPR and number of hospital live admissions', 'spontaneous circulation recovery', 'insertion success rate', 'mean capnometric values']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0454825', 'cui_str': 'Mallorca'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0600228', 'cui_str': 'Cardiorespiratory arrest'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1298904', 'cui_str': 'Device used'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",23.0,0.0147762,"The insertion success rate of the I-Gel® was 92.9% at the first attempt, the mean capnometric values were 16.3mmHg in the control group and 27.4% in the intervention group.","[{'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Cereceda-Sánchez', 'Affiliation': 'Gerencia SAMU 061 Baleares, Palma de Mallorca, Islas Baleares, España. Electronic address: frajocesa@gmail.com.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Clar-Terradas', 'Affiliation': 'Gerencia SAMU 061 Baleares, Palma de Mallorca, Islas Baleares, España.'}, {'ForeName': 'Rut', 'Initials': 'R', 'LastName': 'Moros-Albert', 'Affiliation': 'Gerencia SAMU 061 Baleares, Palma de Mallorca, Islas Baleares, España.'}, {'ForeName': 'Andreu', 'Initials': 'A', 'LastName': 'Mascaró-Galmés', 'Affiliation': 'Gerencia SAMU 061 Baleares, Palma de Mallorca, Islas Baleares, España.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Navarro-Miró', 'Affiliation': 'Gerencia SAMU 061 Baleares, Palma de Mallorca, Islas Baleares, España.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Molina-Mula', 'Affiliation': 'Universidad de las Islas Baleares.'}]",Atencion primaria,['10.1016/j.aprim.2021.102062']
1305,34029235,Shockwave Therapy Plus Eccentric Exercises Versus Isolated Eccentric Exercises for Achilles Insertional Tendinopathy: A Double-Blinded Randomized Clinical Trial.,"BACKGROUND


There remains a lack of consensus regarding the treatment of Achilles insertional tendinopathy. The condition is typically treated with eccentric exercises despite the absence of satisfactory and sustained results. Shockwave therapy was presented as an alternative, but there is a paucity of literature, with good outcomes, supporting its use. The purpose of the present single-center, double-blinded, placebo-controlled, randomized trial was to determine if the use of shockwave therapy in combination with eccentric exercises improves pain and function in patients with Achilles insertional tendinopathy.
METHODS


A total of 119 patients with Achilles insertional tendinopathy were evaluated and enrolled in the study from February 2017 to February 2019. Patients were allocated to 1 of 2 treatment groups, eccentric exercises with extracorporeal shockwave therapy (SWT group) and eccentric exercises with sham shockwave therapy (control group). Three sessions of radial shockwaves (or sham treatment) were performed every 2 weeks and eccentric exercises were undertaken for 3 months. The primary outcome was the Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A) at 24 weeks. Secondary outcomes included the visual analogue scale, algometry, the Foot and Ankle Outcome Score, and the 12-Item Short Form Health Survey.
RESULTS


Both groups showed significant improvement during the study period; however, there were no between-group differences in any of the outcomes (all p >0.05). At the 24-week evaluation, the SWT group exhibited a mean VISA-A of 63.2 (95% confidence interval, 8.0) compared with 62.3 (95% confidence interval, 6.9) in the control group (p = 0.876). There was a higher rate of failure (38.3%) but a lower rate of recurrence (17.0%) in the SWT group compared with the control group (11.5% and 34.6%, respectively; p = 0.002 and p = 0.047). There were no complications reported for either group.
CONCLUSIONS


Extracorporeal shockwave therapy does not potentiate the effects of eccentric strengthening in the management of Achilles insertional tendinopathy.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2021,"There were no complications reported for either group.
","['Achilles Insertional Tendinopathy', '119 patients with Achilles insertional tendinopathy were evaluated and enrolled in the study from February 2017 to February 2019', 'patients with Achilles insertional tendinopathy']","['Shockwave therapy', 'Extracorporeal shockwave therapy', 'Shockwave Therapy Plus Eccentric Exercises', 'SWT', 'eccentric exercises', 'Isolated Eccentric Exercises', 'shockwave therapy', 'placebo', 'eccentric exercises with extracorporeal shockwave therapy (SWT group) and eccentric exercises with sham shockwave therapy (control group']","['visual analogue scale, algometry, the Foot and Ankle Outcome Score, and the 12-Item Short Form Health Survey', 'Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A', 'rate of recurrence', 'rate of failure', 'pain and function']","[{'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2960382', 'cui_str': 'Victorian Institute of Sport Assessment-Achilles questionnaire'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",119.0,0.275469,"There were no complications reported for either group.
","[{'ForeName': 'Nacime Salomão Barbachan', 'Initials': 'NSB', 'LastName': 'Mansur', 'Affiliation': 'Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fabio Teruo', 'Initials': 'FT', 'LastName': 'Matsunaga', 'Affiliation': ''}, {'ForeName': 'Oreste Lemos', 'Initials': 'OL', 'LastName': 'Carrazzone', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Schiefer Dos Santos', 'Affiliation': ''}, {'ForeName': 'Carlos Gilberto', 'Initials': 'CG', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Bruno Takeshi', 'Initials': 'BT', 'LastName': 'Aoyama', 'Affiliation': ''}, {'ForeName': 'Paulo Roberto', 'Initials': 'PR', 'LastName': 'Dias Dos Santos', 'Affiliation': ''}, {'ForeName': 'Flávio', 'Initials': 'F', 'LastName': 'Faloppa', 'Affiliation': ''}, {'ForeName': 'Marcel Jun Sugawara', 'Initials': 'MJS', 'LastName': 'Tamaoki', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.01826']
1306,34029219,Virtual reality-based preprocedural education increases preparedness and satisfaction of patients about the catheter ablation of atrial fibrillation.,"BACKGROUND


A recent study suggested to develop and implement more interacted material for preprocedural education to decrease patients' anxiety about the atrial fibrillation (AF) ablation. This study compared the effectiveness of using either newly developed virtual reality (VR) materials (VR group) or paper-based materials (paper group) on giving AF preprocedural education.
METHODS


This study consequentially enrolled 33 AF patients preparing for ablation from November 2019 to October 2020. After enrollment, patients were randomized as either paper (n = 22) or VR (n = 11) groups.
RESULTS


In comparison with the baseline stage, at the posteducation stage, the degree of improvement in patients' self-assessed self-efficacy on AF ablation knowledge was higher among VR group patients than those in the paper group. At the posteducation stage, the patients' satisfaction to preprocedural education and used materials were higher among the VR group than that among the paper group. In addition to meet their needs and give accurate medical information, VR group patients reported that VR materials increased the effectiveness of education, increased their preparedness for AF catheter ablation, achieved paperless purposes, and willing to recommend VR materials to others. Operators subjectively reported that the periprocedure cooperation was increased both among paper and VR group patients after preprocedural education for the details of procedure. Better preparedness of VR group patients was supported by less periprocedure pain, anxiety, and impatience than those among paper group patients.
CONCLUSION


Interactive VR-based materials are superior to the paper-based materials to provide patients immerse and imagine the journey and detail knowledge of AF catheter ablation before the procedure and better prepared patients for the procedure.",2021,Operators subjectively reported that the peri-procedure cooperation was increased both among paper and VR group patients after preprocedural education for the details of procedure.,['33 AF patients preparing for Ablation from November 2019 to October 2020'],"['VR', 'newly developed virtual reality (VR) materials (VR group) or paper-based materials (paper group) on giving AF pre-procedural education', 'VR-based pre-procedural education']","['peri-procedure pain, anxiety, and impatience', 'patients self-assessed self-efficacy on AF ablation knowledge', 'peri-procedure cooperation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0919568', 'cui_str': 'Impatience'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",33.0,0.0066215,Operators subjectively reported that the peri-procedure cooperation was increased both among paper and VR group patients after preprocedural education for the details of procedure.,"[{'ForeName': 'Shih-Lin', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': 'Heart Rhythm Center, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ming-Jen', 'Initials': 'MJ', 'LastName': 'Kuo', 'Affiliation': 'Heart Rhythm Center, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Yenn-Jiang', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Heart Rhythm Center, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shih-Ann', 'Initials': 'SA', 'LastName': 'Chen', 'Affiliation': 'Heart Rhythm Center, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chung-Ting', 'Initials': 'CT', 'LastName': 'Chen', 'Affiliation': 'Faculty of Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': 'Faculty of Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Yang', 'Affiliation': 'Faculty of Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shou-Yen', 'Initials': 'SY', 'LastName': 'Kao', 'Affiliation': 'Department of Stomatology, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Shulruf', 'Affiliation': 'New South Wales Sydney University, Australia.'}, {'ForeName': 'Fa-Yauh', 'Initials': 'FY', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000555']
1307,34047177,Increments in DNA-thioguanine level during thiopurine-enhanced maintenance therapy of acute lymphoblastic leukemia.,"Maintenance therapy containing methotrexate and 6-mercapto - purine is essential to cure acute lymphoblastic leukemia (ALL). Cytotoxicity is elicited by incorporation of thioguanine nucleotides into DNA (DNA-TG), and higher leukocyte DNA-TG is associated with increased relapse-free survival. As 6-thioguanine provides 6- fold higher cytosolic levels of thioguanine nucleotides than does 6- mercapto purine, we added low-dose 6-thioguanine to methotrexate/6- mercapto purine maintenance therapy to explore if this combination results in significantly higher DNA-TG. The target population of the ""Thiopurine Enhanced ALL Maintenance therapy"" (TEAM) study was 30 patients with non-high-risk ALL, aged 1-45 years on methotrexate/6-mercaptopurine maintenance therapy receiving no other systemic chemotherapy. Incremental doses of 6-thioguanine were added to methotrexate/6-mercaptopurine maintenance therapy (starting 6-thioguanine dose: 2.5 mg/m2/day, maximum: 12.5 mg/m2/day). The primary endpoint was DNA-TG increments. Thirty-four patients were included, and 30 patients completed maintenance therapy according to the TEAM strategy. Of these 30 patients, 26 (87%) tolerated 10.0-12.5 mg/m2/day as the maximum 6-thioguanine dose. TEAM resulted in significantly higher DNA-TG levels compared to those in both TEAM patients before their inclusion in TEAM (on average 251 fmol/mg DNA higher [95% confidence interval: 160-341; P<0.0001]), and with historical patients receiving standard methotrexate/6-mercapto - purine maintenance therapy (on average 272 fmol/mg DNA higher [95% confidence interval: 147-398; P<0.0001]). TEAM did not increase myelotoxicity or hepatotoxicity. In conclusion, TEAM is an innovative and feasible approach to improve maintenance therapy and results in higher DNA-TG levels without inducing additional toxicity. It may therefore be an effective strategy to reduce the risk of ALL relapse through increased DNA-TG. This will be tested in a randomized ALLTogether-1 substudy.",2021,"TEAM resulted in significantly higher DNA-TG, when compared with both TEAM patients before TEAM inclusion (on average 251 fmol/μg DNA higher (95% CI 160-341; P<0.0001), and with historical patients receiving standard MTX/6MP maintenance therapy (on average 272 fmol/μg DNA higher (95% CI 147-398; P<0.0001).","['n=30', 'acute lymphoblastic leukemia', 'Thirty-four patients were included, and 30 patients completed maintenance therapy according to TEAM strategy', 'patients, with non-high risk ALL, aged 1-45 years on MTX/6MP maintenance therapy receiving no other systemic chemotherapy']","['Methotrexate (MTX) and 6-Mercaptopurine (6MP', '6-Thioguanine (6TG', 'MTX/6MP maintenance therapy', 'standard MTX/6MP maintenance therapy', 'thiopurine', '6TG']","['myelotoxicity or hepatotoxicity', 'DNA-TG increments', 'DNA-TG']","[{'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0039902', 'cui_str': 'Thioguanine'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}]",34.0,0.0729541,"TEAM resulted in significantly higher DNA-TG, when compared with both TEAM patients before TEAM inclusion (on average 251 fmol/μg DNA higher (95% CI 160-341; P<0.0001), and with historical patients receiving standard MTX/6MP maintenance therapy (on average 272 fmol/μg DNA higher (95% CI 147-398; P<0.0001).","[{'ForeName': 'Rikke Hebo', 'Initials': 'RH', 'LastName': 'Larsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Utke Rank', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen; Department of Hematology, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Grell', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen; Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Nørgaard Møller', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Malthe Overgaard', 'Affiliation': 'Department of Hematology, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kampmann', 'Affiliation': 'Department of Hematology, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Nersting', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Degn', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Nygaard Nielsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Holst', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Klug Albertsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Aarhus University, Aarhus; Department of Clinical Medicine, Aarhus University, Health, Aarhus.'}, {'ForeName': 'Peder', 'Initials': 'P', 'LastName': 'Skov Wehner', 'Affiliation': ""Department of Pediatric Hematology and Oncology, H.C. Andersen Children's Hospital, Odense University Hospital, Odense.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thude Callesen', 'Affiliation': ""Department of Pediatric Hematology and Oncology, H.C. Andersen Children's Hospital, Odense University Hospital, Odense.""}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Kanerva', 'Affiliation': ""HUS, Helsinki University Hospital, University of Helsinki, New Children's Hospital, Helsinki.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Leth Frandsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Als-Nielsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lyngsie Hjalgrim', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Schmiegelow', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen; Institute of Clinical Medicine, Faculty of Medicine, University of Copenhagen, Copenhagen.'}]",Haematologica,['10.3324/haematol.2020.278166']
1308,34050763,Effects of Synbiotic Supplementation and Lifestyle Modifications on Women With Polycystic Ovary Syndrome.,"CONTEXT


Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age.
OBJECTIVE


This study was designed to evaluate effects of lifestyle modifications and synbiotic supplementation on PCOS.
DESIGN


A randomized (1:1) double-blind, placebo-controlled trial.
SETTING


Academic hospital.
PATIENTS OR OTHER PARTICIPANTS


Overweight and obese women with PCOS were identified according to the Rotterdam criteria. Evaluations were performed at baseline and repeated after 3 months of treatment.
INTERVENTION


Lifestyle modifications in combination with synbiotic supplementation or placebo.
MAIN OUTCOME MEASURES


Change in body mass index (BMI) and testosterone level.
RESULTS


In the placebo group, a 5% decrease in BMI was accompanied by significant decreases of the waist, hip, and thigh circumferences. The synbiotic group experienced an 8% decrease in BMI, which was significantly greater than that in the control group (P = 0.03) and was accompanied by decreases in the waist, hip, and thigh circumferences. Testosterone did not decrease significantly in the placebo group (decrease of 6%), whereas in the synbiotic group it decreased by 32% (P < 0.0001). The decrease of testosterone was significantly greater in the synbiotic group than in the placebo group (P = 0.016).
CONCLUSIONS


Synbiotic supplementation potentiated effects of lifestyle modifications on weight loss and led to significant reduction of serum testosterone.",2021,"The Synbiotic Group experienced an 8% decrease in BMI, which was significantly greater than that in the Control Group (P=0.03) and was accompanied by decreases in the waist, hip, and thigh circumferences.","['Academic hospital', 'Overweight and obese women with PCOS', 'women with polycystic ovary syndrome']","['Synbiotic supplementation', 'synbiotic supplementation', 'synbiotic supplementation or placebo', 'Placebo', 'placebo']","['waist, hip, and thigh circumferences', 'weight loss', 'serum testosterone', 'decrease of testosterone', 'BMI', 'Testosterone', 'BMI and testosterone level']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]",,0.237899,"The Synbiotic Group experienced an 8% decrease in BMI, which was significantly greater than that in the Control Group (P=0.03) and was accompanied by decreases in the waist, hip, and thigh circumferences.","[{'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Chudzicka-Strugała', 'Affiliation': 'Department of Medical Microbiology, Poznan University of Medical Sciences, Poznan,Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kubiak', 'Affiliation': 'Division of Infertility and Reproductive Endocrinology, Department of Gynecology, Obstetrics and Gynecological Oncology, Poznan University of Medical Sciences, Poznan,Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Banaszewska', 'Affiliation': 'Division of Infertility and Reproductive Endocrinology, Department of Gynecology, Obstetrics and Gynecological Oncology, Poznan University of Medical Sciences, Poznan,Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Zwozdziak', 'Affiliation': 'Department of Medical Microbiology, Poznan University of Medical Sciences, Poznan,Poland.'}, {'ForeName': 'Martyna', 'Initials': 'M', 'LastName': 'Siakowska', 'Affiliation': 'Division of Infertility and Reproductive Endocrinology, Department of Gynecology, Obstetrics and Gynecological Oncology, Poznan University of Medical Sciences, Poznan,Poland.'}, {'ForeName': 'Leszek', 'Initials': 'L', 'LastName': 'Pawelczyk', 'Affiliation': 'Division of Infertility and Reproductive Endocrinology, Department of Gynecology, Obstetrics and Gynecological Oncology, Poznan University of Medical Sciences, Poznan,Poland.'}, {'ForeName': 'Antoni J', 'Initials': 'AJ', 'LastName': 'Duleba', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, La Jolla, CA, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab369']
1309,34091568,Effectiveness of a Nurse-Delivered Intervention on Illness Perceptions and Quality of Life in Patients With Injury.,"BACKGROUND


Research has shown that nursing interventions are able to affect short-term outcomes in patients with injury. However, evidence based on a comprehensive nurse-led intervention may be beneficial for trauma care.
PURPOSE


This study was designed to assess the effect of a nursing intervention on the illness perceptions and quality of life of patients with injury.
METHODS


A two-group experimental design and a follow-up period of 12 months were used. Ninety-four patients were randomly assigned to either the experimental group or the control group. A nurse-led cognitive behavioral therapy intervention was used to improve outcomes.
RESULTS


The illness perception variables of ""personal control"" and ""treatment control"" were found to be significantly improved in the experimental group at 3 months after discharge, whereas ""emotional perception"" was significantly improved at 6 months after discharge. The intervention was also shown to improve ""social quality of life"" at 6 and 12 months after injury.
CONCLUSIONS


This study adds new knowledge related to nursing interventions for patients with injury in terms of the intervention achieving longer-term effects than the interventions examined in previous studies. The results highlight the importance of providing interprofessional collaborative care. However, the intervention protocol should be tested further in future studies.",2021,"The illness perception variables of ""personal control"" and ""treatment control"" were found to be significantly improved in the experimental group at 3 months after discharge, whereas ""emotional perception"" was significantly improved at 6 months after discharge.","['patients with injury', 'Patients With Injury', 'Ninety-four patients']","['nursing intervention', 'cognitive behavioral therapy intervention', 'Nurse-Delivered Intervention']","['social quality of life', 'illness perception variables of ""personal control"" and ""treatment control', 'emotional perception', 'illness perceptions and quality of life', 'Illness Perceptions and Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",94.0,0.0208963,"The illness perception variables of ""personal control"" and ""treatment control"" were found to be significantly improved in the experimental group at 3 months after discharge, whereas ""emotional perception"" was significantly improved at 6 months after discharge.","[{'ForeName': 'Wen-Chih', 'Initials': 'WC', 'LastName': 'Fann', 'Affiliation': 'MSc, MD, Attending Physician, Department of Emergency Medicine, Chia-Yi Chang Gung Memorial Hospital, Taiwan.'}, {'ForeName': 'Chang-Chiao', 'Initials': 'CC', 'LastName': 'Hung', 'Affiliation': 'PhD, RN, Associate Professor, Department of Nursing, Chang Gung University of Science and Technology, and Associate Research Fellow, Department of Nursing, Chia-Yi Chang Gung Memorial Hospital, Taiwan.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Chaboyer', 'Affiliation': 'PhD, RN, Professor, School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, Queensland, Australia.'}, {'ForeName': 'Bih-O', 'Initials': 'BO', 'LastName': 'Lee', 'Affiliation': 'PhD, RN, Professor, College of Nursing, Kaohsiung Medical University, Taiwan, and Adjunct Professor, Faculty of Nursing, Universitas Airlangga, Indonesia.'}]",The journal of nursing research : JNR,['10.1097/JNR.0000000000000439']
1310,34023938,Effects of daily consumption of wild blueberry on cognition and urinary metabolites in school-aged children: a pilot study.,"PURPOSE


Acute intervention with wild blueberry (WBB) has previously revealed positive cognitive and mood effects in typically developing children; however, it is unclear whether effects persist after daily supplementation. In addition, no data have been published exploring the metabolite profiles of children following berry consumption, to our knowledge. A study of this kind could provide insight into a mechanism of action for the cognitive and mood improvements observed previously in children. The aim of this pilot study was to assess cognitive performance and urinary metabolite concentrations in healthy 7-10-year-old children across a 4 week daily WBB drink intervention.
METHODS


This pilot study examined the effects of daily WBB consumption for 4 weeks (766 mg total polyphenols; 253 mg anthocyanins; equivalent to 240 g fresh blueberries per day) on cognition and mood in 15 healthy 7-10-year-old children. Polyphenol metabolites were measured in 24 h urine before and after the 4 week intervention.
RESULTS


Chronic WBB-related benefits were seen on cognitively demanding trials on the modified attention network task, a task measuring executive functioning. Specifically, the WBB group maintained significantly higher accuracy on incongruent trials (96%; SE 0.03) compared with placebo participants (85%; SE 0.03; p = 0.038) after the 4 week intervention, suggesting WBB was of most benefit on the more difficult aspects of the task. No significant WBB-related effects were observed on the auditory verbal learning task or the child's version of the positive and negative affect schedule. Urinary metabolite analyses indicated significant increases in different metabolites in WBB and placebo groups after 4 week consumption.
CONCLUSION


The research demonstrates 24 h WBB bioavailability in a child cohort for the first time with increases in urinary hippuric acid excretion during 2 week daily WBB consumption. This study highlights the importance of conducting a larger study in children investigating the mechanism of action behind cognitive effects using bioavailability data.",2021,"Specifically, the WBB group maintained significantly higher accuracy on incongruent trials (96%; SE 0.03) compared with placebo participants (85%; SE 0.03; p = 0.038) after the 4 week intervention, suggesting WBB was of most benefit on the more difficult aspects of the task.","['school-aged children', 'children', 'healthy 7-10-year-old children across a 4\xa0week daily WBB drink intervention', '15 healthy 7-10-year-old children']","['wild blueberry (WBB', 'daily WBB consumption', 'total polyphenols; 253\xa0mg anthocyanins', 'daily consumption of wild blueberry', 'placebo']","['Polyphenol metabolites', 'cognition and urinary metabolites', 'cognitive performance and urinary metabolite concentrations', 'urinary hippuric acid excretion', ""auditory verbal learning task or the child's version of the positive and negative affect schedule""]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0950037', 'cui_str': 'Blueberries'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0950037', 'cui_str': 'Blueberries'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0062725', 'cui_str': 'Hippuric acid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}]",,0.0745389,"Specifically, the WBB group maintained significantly higher accuracy on incongruent trials (96%; SE 0.03) compared with placebo participants (85%; SE 0.03; p = 0.038) after the 4 week intervention, suggesting WBB was of most benefit on the more difficult aspects of the task.","[{'ForeName': 'Katie Louise', 'Initials': 'KL', 'LastName': 'Barfoot', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley Gate, Whiteknights Road, Reading, UK.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Istas', 'Affiliation': 'Department of Nutritional Sciences, School of Life Course Sciences, Kings College London, London, UK.'}, {'ForeName': 'Rodrigo Pedro', 'Initials': 'RP', 'LastName': 'Feliciano', 'Affiliation': 'Division of Cardiology, Pulmonology, and Vascular Medicine, University Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Daniel Joseph', 'Initials': 'DJ', 'LastName': 'Lamport', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley Gate, Whiteknights Road, Reading, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Riddell', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley Gate, Whiteknights Road, Reading, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Mateos', 'Affiliation': 'Department of Nutritional Sciences, School of Life Course Sciences, Kings College London, London, UK.'}, {'ForeName': 'Claire Michelle', 'Initials': 'CM', 'LastName': 'Williams', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley Gate, Whiteknights Road, Reading, UK. claire.williams@reading.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-021-02588-y']
1311,34038624,Leisure walks modulate the cognitive and affective representation of the corona pandemic: Employing Cognitive-Affective Maps within a randomized experimental design.,"In response to the corona pandemic, many leisure activities have been restricted while walking has been explicitly endorsed by health authorities. We investigated how leisure walking affects individuals' attitudes to the pandemic. We used Cognitive-Affective Maps (CAMs) to measure individual's cognitive and affective attitudes toward the corona pandemic and related issues. In a controlled randomized experiment, we asked (N = 66) participants to draw a CAM before and after a walk. Participants in a control group drew CAMs before and after any self-chosen activity at home. We found that walking led to a more negative evaluation of the pandemic itself, likely due to a more intense reflection, while in everyday routines one has already adapted to it. In further qualitative post hoc assessments of the CAMs, we observed that negative concepts other than corona disappeared after walking. We conclude that leisure walks have complex effects on individuals' cognitive and affective conceptualization of the corona pandemic. Hence, the exact mechanisms of these effects need to be examined in future research. Our study has also shown that CAMs are a promising tool for measuring experimental interventions in health psychology.",2021,"We found that walking led to a more negative evaluation of the pandemic itself, likely due to a more intense reflection, while in everyday routines one has already adapted to it.",[],"['Cognitive-Affective Maps (CAMs', 'Leisure walks modulate the cognitive and affective representation of the corona pandemic', 'CAMs', 'leisure walking']",[],[],"[{'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]",[],66.0,0.0241158,"We found that walking led to a more negative evaluation of the pandemic itself, likely due to a more intense reflection, while in everyday routines one has already adapted to it.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Reuter', 'Affiliation': 'Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Fenn', 'Affiliation': 'Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Tobias Andreas', 'Initials': 'TA', 'LastName': 'Bilo', 'Affiliation': 'Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schulz', 'Affiliation': 'Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Annemarie Lina', 'Initials': 'AL', 'LastName': 'Weyland', 'Affiliation': 'Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kiesel', 'Affiliation': 'Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Thomaschke', 'Affiliation': 'Institute of Psychology, University of Freiburg, Freiburg, Germany.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12283']
1312,34042314,"Efficacy, Safety, and Pharmacodynamic Effects of the Bruton's Tyrosine Kinase Inhibitor Fenebrutinib (GDC-0853) in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Trial.","OBJECTIVE


Fenebrutinib (GDC-0853) is a noncovalent, oral, and highly selective inhibitor of Bruton's tyrosine kinase (BTK). The efficacy, safety, and pharmacodynamics of fenebrutinib in systemic lupus erythematosus (SLE) were assessed in this phase II, multicenter, randomized, placebo-controlled study.
METHODS


Patients who had moderately to severely active SLE while receiving background standard therapy were randomized to receive placebo, fenebrutinib 150 mg once daily, or fenebrutinib 200 mg twice daily. Glucocorticoid taper was recommended from weeks 0 to 12 and from weeks 24 to 36. The primary end point was the SLE Responder Index 4 (SRI-4) response at week 48.
RESULTS


Patients (n = 260) were enrolled from 44 sites in 12 countries, with the majority from Latin America, the US, and Western Europe. The SRI-4 response rates at week 48 were 51% for fenebrutinib 150 mg once daily (P = 0.37 versus placebo), 52% for fenebrutinib 200 mg twice daily (P = 0.34 versus placebo), and 44% for placebo. British Isles Lupus Assessment Group-based Combined Lupus Assessment response rates at week 48 were 53% for fenebrutinib 150 mg once daily (P = 0.086 versus placebo), 42% for fenebrutinib 200 mg twice daily (P = 0.879 versus placebo), and 41% for placebo. Safety results were similar across all arms, although serious adverse events were more frequent with fenebrutinib 200 mg twice daily. By week 48, patients treated with fenebrutinib had reduced levels of a BTK-dependent plasmablast RNA signature, anti-double-stranded DNA autoantibodies, total IgG, and IgM, as well as increased complement C4 levels, all relative to placebo.
CONCLUSION


While fenebrutinib had an acceptable safety profile, the primary end point, SRI-4 response, was not met despite evidence of strong pathway inhibition.",2021,"BICLA response rates at W48 were 53% (p=0.086, versus placebo) for FEN 150 mg QD, 42% (p=0.879, versus placebo) for FEN 200 mg BID, and 41% for placebo.","['Systemic Lupus Erythematosus', 'Patients (N=260) were enrolled from 44 sites in 12 countries, with the majority from Latin America, USA, and Western Europe', 'Patients with moderate-to-severely active systemic lupus erythematosus on background standard of care therapy']","[""Bruton's Tyrosine Kinase Inhibitor, Fenebrutinib (GDC-0853"", 'FEN', 'placebo', 'placebo, FEN 150 mg QD, or FEN']","['SRI-4 at W48', 'Efficacy, Safety, and Pharmacodynamic Effects', 'SRI-4 response rates', 'BICLA response rates', 'acceptable safety profile', 'serious adverse events', 'reduced levels of a BTK-dependent plasmablast RNA signature, anti-dsDNA autoantibodies, total IgG, and IgM', 'efficacy, safety, and pharmacodynamics of FEN']","[{'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0043129', 'cui_str': 'West European country'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4521488', 'cui_str': 'Non-specific protein-tyrosine kinase inhibitor'}, {'cui': 'C3896852', 'cui_str': 'GDC-0853'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0218158', 'cui_str': ""Bruton's Tyrosine Kinase""}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0229657', 'cui_str': 'Plasmablast'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}]",260.0,0.193596,"BICLA response rates at W48 were 53% (p=0.086, versus placebo) for FEN 150 mg QD, 42% (p=0.879, versus placebo) for FEN 200 mg BID, and 41% for placebo.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Isenberg', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Furie', 'Affiliation': 'Northwell Health, Great Neck, New York.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Jones', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Guibord', 'Affiliation': 'Hoffmann-La Roche, Mississauga, Ontario, Canada.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Galanter', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Chin', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGregor', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Toth', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Rae', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Hwang', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Desai', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Armend', 'Initials': 'A', 'LastName': 'Lokku', 'Affiliation': 'Hoffmann-La Roche, Mississauga, Ontario, Canada.'}, {'ForeName': 'Nandhini', 'Initials': 'N', 'LastName': 'Ramamoorthi', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Hackney', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Miranda', 'Affiliation': 'Centro Estudios Reumatologicos, Santiago, Chile.'}, {'ForeName': 'Viviane A', 'Initials': 'VA', 'LastName': 'de Souza', 'Affiliation': 'Centro Mineiro de Pesquisas, Juiz de Fora, Brazil.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Jaller-Raad', 'Affiliation': 'Centro de Reumatologia y Ortopedia, Cimedical, Barranquilla, Colombia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Maura Fernandes', 'Affiliation': 'Mario Covas Hospital, Santo Andre, Sao Paulo, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Garcia Salinas', 'Affiliation': 'Hospital Italiano de La Plata, Buenos Aires, Argentina.'}, {'ForeName': 'Leslie W', 'Initials': 'LW', 'LastName': 'Chinn', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Townsend', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Morimoto', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Tuckwell', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41811']
1313,34390923,Concentric not eccentric cycling sprint intervals acutely impair balance and jump performance in healthy active young adults: A randomized controlled cross-over study.,"INTRODUCTION


Moderate aerobic, high-intensity and sprint running or cycling training can transiently impair postural control. However, the acute effects of modified sprint interval training (mSIT) at different muscle working modes have not yet been examined. Thus, this study aimed at investigating acute effects of time-matched eccentric (ECC) versus concentric mSIT cycling session (CON) on jumping and functional balance performance.
METHODS


Twenty-five healthy and active males (30.0 ± 6.0 years; 80.1 ± 9.1 kg; V̇O 2max : 64.2 ± 7.9 mL kg -1  min -1 ) were enrolled in this acute randomized controlled crossover trial. Counter-Movement-Jump (CMJ) and functional balance testing (Y-Balance-Test composite score [YBT CS ]; Posturomed total distance: Posturomed TD ) were assessed as primary outcomes before, and immediately after cessation of ECC and CON (10 × 10 s maximum sprints and 50 s of active recovery).
RESULTS


A significant mode × time interaction effect for CMJ (F = 9.620, p = 0.005, η p 2  = 0.29) was observed. Subsequent post-hoc testing revealed significant moderate reductions in jumping height after CON (0.31 ± 0.06 vs. 0.27 ± 0.06m; p = 0.004, SMD = 0.59), whilst ECC remained unchanged. YBT CS  (mode × time interaction: F = 6.880, p = 0.015, η p 2  = 0.22) showed small but significant balance impairments after CON (0.964 ± 0.068 vs. 0.960 ± 0.063 AU; p = 0.009, SMD = 0.28) and did not significantly change after ECC. Although large significant interaction effects (p = 0.029, η p 2  = 0.18) were observed for Posturomed TD , follow up post-hoc testing did not reveal relevant pre-post differences, neither for ECC nor CON.
CONCLUSION


Both functional balance and jumping performance are deteriorated after acute concentric but not eccentric mSIT cycling. Although higher pedal forces at lower perceived efforts and heart rates during eccentric mSIT were observed, it seems that the cardiocirculatory demanding CON session elicited more pronounced balance and jump performance impairments than eccentric cycling.",2021,"A significant mode × time interaction effect for CMJ (F = 9.620, p = 0.005, η p 2  = 0.29) was observed.","['Twenty-five healthy and active males (30.0\u2009±\u20096.0 years; 80.1\u2009±\u20099.1\u2009kg; V̇O 2max : 64.2\u2009±\u20097.9\u2009mL\u2009kg -1 \u2009min -1 ', 'healthy active young adults']","['modified sprint interval training (mSIT', 'Counter-Movement-Jump (CMJ) and functional balance testing (Y-Balance-Test composite score [YBT CS ', 'Concentric not eccentric cycling sprint', 'Moderate aerobic, high-intensity and sprint running or cycling training', 'time-matched eccentric (ECC) versus concentric mSIT cycling session (CON']",[],"[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]",[],25.0,0.0826088,"A significant mode × time interaction effect for CMJ (F = 9.620, p = 0.005, η p 2  = 0.29) was observed.","[{'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Rappelt', 'Affiliation': 'Intervention Research in Exercise Training, German Sports University Cologne, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'Intervention Research in Exercise Training, German Sports University Cologne, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Donath', 'Affiliation': 'Intervention Research in Exercise Training, German Sports University Cologne, Germany. Electronic address: l.donath@dshs-koeln.de.'}]",Gait & posture,['10.1016/j.gaitpost.2021.08.006']
1314,34045241,"Dose-Dependent Associations of Dietary Glycemic Index, Glycemic Load, and Fiber With 3-Year Weight Loss Maintenance and Glycemic Status in a High-Risk Population: A Secondary Analysis of the Diabetes Prevention Study PREVIEW.","OBJECTIVE


To examine longitudinal and dose-dependent associations of dietary glycemic index (GI), glycemic load (GL), and fiber with body weight and glycemic status during 3-year weight loss maintenance (WLM) in adults at high risk of type 2 diabetes.
RESEARCH DESIGN AND METHODS


In this secondary analysis we used pooled data from the PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World (PREVIEW) randomized controlled trial, which was designed to test the effects of four diet and physical activity interventions. A total of 1,279 participants with overweight or obesity (age 25-70 years and BMI ≥25 kg ⋅ m -2 ) and prediabetes at baseline were included. We used multiadjusted linear mixed models with repeated measurements to assess longitudinal and dose-dependent associations by merging the participants into one group and dividing them into GI, GL, and fiber tertiles, respectively.
RESULTS


In the available-case analysis, each 10-unit increment in GI was associated with a greater regain of weight (0.46 kg ⋅ year -1 ; 95% CI 0.23, 0.68;  P  < 0.001) and increase in HbA 1c . Each 20-unit increment in GL was associated with a greater regain of weight (0.49 kg ⋅ year -1 ; 0.24, 0.75;  P  < 0.001) and increase in HbA 1c . The associations of GI and GL with HbA 1c  were independent of weight change. Compared with those in the lowest tertiles, participants in the highest GI and GL tertiles had significantly greater weight regain and increases in HbA 1c . Fiber was inversely associated with increases in waist circumference, but the associations with weight regain and glycemic status did not remain robust in different analyses.
CONCLUSIONS


Dietary GI and GL were positively associated with weight regain and deteriorating glycemic status. Stronger evidence on the role of fiber is needed.",2021,"Compared with those in the lowest tertiles, participants in the highest GI and GL tertiles had significantly greater weight regain and increases in HbA 1c .","['1,279 participants with overweight or obesity (age 25-70 years and BMI ≥25 kg ⋅ m -2 ) and prediabetes at baseline were included', 'a High-Risk Population', 'adults at high risk of type 2 diabetes']",[],"['weight regain and deteriorating glycemic status', 'weight regain and increases in HbA 1c ', 'waist circumference', 'dietary glycemic index (GI), glycemic load (GL), and fiber with body weight and glycemic status during 3-year weight loss maintenance (WLM', 'HbA 1c ', 'regain of weight', 'Dietary Glycemic Index, Glycemic Load, and Fiber With 3-Year Weight Loss Maintenance and Glycemic Status', 'weight regain and glycemic status']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1444752', 'cui_str': 'Status during'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",1279.0,0.149482,"Compared with those in the lowest tertiles, participants in the highest GI and GL tertiles had significantly greater weight regain and increases in HbA 1c .","[{'ForeName': 'Ruixin', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Fogelholm', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Sally D', 'Initials': 'SD', 'LastName': 'Poppitt', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Pia S', 'Initials': 'PS', 'LastName': 'Vestentoft', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marta P', 'Initials': 'MP', 'LastName': 'Silvestre', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Jalo', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Navas-Carretero', 'Affiliation': 'Centre for Nutrition Research, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Huttunen-Lenz', 'Affiliation': 'Institute for Nursing Science, University of Education Schwäbisch Gmünd, Schwäbisch Gmünd, Germany.'}, {'ForeName': 'Moira A', 'Initials': 'MA', 'LastName': 'Taylor', 'Affiliation': ""Division of Physiology, Pharmacology and Neuroscience, School of Life Sciences, Queen's Medical Centre, Nottingham, U.K.""}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Stratton', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, Swansea University, Swansea, U.K.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Swindell', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, Swansea University, Swansea, U.K.'}, {'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Drummen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Tanja C', 'Initials': 'TC', 'LastName': 'Adam', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jouko', 'Initials': 'J', 'LastName': 'Sundvall', 'Affiliation': 'Department of Government Services, Forensic Toxicology Unit, Biochemistry Laboratory, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Liisa M', 'Initials': 'LM', 'LastName': 'Valsta', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Brodie', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Handjieva-Darlenska', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Svetoslav', 'Initials': 'S', 'LastName': 'Handjiev', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': 'Centro de Investigacion Biomedica en Red Area de Fisiologia de la Obesidad y la Nutricion (CIBEROBN), Madrid, Spain.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Macdonald', 'Affiliation': ""Division of Physiology, Pharmacology and Neuroscience, School of Life Sciences, Queen's Medical Centre, MRC/ARUK Centre for Musculoskeletal Ageing Research, ARUK Centre for Sport, Exercise and Osteoarthritis, National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham, U.K.""}, {'ForeName': 'Margriet S', 'Initials': 'MS', 'LastName': 'Westerterp-Plantenga', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Brand-Miller', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark ara@nexs.ku.dk.'}]",Diabetes care,['10.2337/dc20-3092']
1315,34032304,Oxytocin facilitates socially directed attention.,"Socially directed gaze following is an important component of social interaction and communication, allowing us to attend mutually with others to objects or people so that we can share their experience and also learn from them. This type of joint social attention is impaired in disorders such as autism. Previous research has demonstrated that the neuropeptide oxytocin can facilitate attention toward social cues, although to date no study in humans has investigated its influence on socially directed gaze or on associations of the latter with autistic and empathic traits. In a within-subject, randomized, placebo-controlled trial we used eye-tracking to investigate the effects of intranasal oxytocin (24 IU) on socially directed gaze toward one of two objects in 40 adult male subjects. Subjects viewed videos of an actor and actress directing their gaze toward one of two objects by either moving only their eyes, moving both their eyes and head, or moving their eyes and head and pointing with a finger. Results showed that OXT increased the proportion of time subjects viewed the object the actor or actress were looking/pointing at across all three conditions, although unexpectedly we found no associations with trait autism or empathy under either placebo or OXT treatments. These findings demonstrate that OXT can facilitate socially directed gaze following to promote mutual attention toward objects which may be potentially beneficial therapeutically in disorders with impaired social communication and interaction.",2021,"Results showed that OXT increased the proportion of time subjects viewed the object the actor or actress were looking/pointing at across all three conditions, although unexpectedly we found no associations with trait autism or empathy under either placebo or OXT treatments.",['40 adult male subjects'],"['videos of an actor and actress directing their gaze toward one of two objects by either moving only their eyes, moving both their eyes and head, or moving their eyes and head and pointing with a finger', 'Oxytocin', 'intranasal oxytocin', 'neuropeptide oxytocin', 'placebo', 'OXT']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],40.0,0.0600945,"Results showed that OXT increased the proportion of time subjects viewed the object the actor or actress were looking/pointing at across all three conditions, although unexpectedly we found no associations with trait autism or empathy under either placebo or OXT treatments.","[{'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Le', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Kou', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Meina', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}]",Psychophysiology,['10.1111/psyp.13852']
1316,34049323,Residual SYNTAX II Score and long-term outcomes post-ST-elevation myocardial infarction in an urban US cohort: the Montefiore STEMI Registry.,"BACKGROUND


Higher residual anatomic disease was associated with increased mortality in a recent randomized controlled trial of revascularization after ST-elevation myocardial infarction (STEMI). Less is known about the impact of residual disease post-STEMI in race-ethnic minorities.
METHODS


Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX)- II (SS-II) score is an established scoring method for anatomic disease and prevalent co-morbidities to describe patient complexity. We evaluated residual (r) SS-II in 165 patients from a single center urban US registry (n = 1208) presenting for primary percutaneous coronary intervention of STEMI and treated for 3-vessel or left main and any combination of 0, 1, 2 or 3-vessel disease.
RESULTS


The median age was 62 years (IQR 52-70), 29.1% women, 44.9% Hispanic/Latino and 19.4% non-Hispanic Black. Over median of 4.9 years (IQR 2.9-6.3), higher rSS-II was associated with increased death [hazard ratio 2.46 per SD increment in log rSS-II (~1.five-fold increment on the original scale) 95% CI 1.51, 3.99], death or all-cause readmission (hazard ratio 1.37 per SD increment in log rSS-II 95% CI, 1.11-1.70) and death or cardiovascular disease readmission (hazard rati 1.46 per SD increment in log rSS-II 95% CI, 1.14-1.88). rSS-II was higher in older women with more co-morbidities, but not different by race-ethnicity.
CONCLUSIONS


In summary, higher rSS-II was associated with long-term outcomes post-STEMI in a prospective urban, minority cohort, suggesting a potential role for risk stratification with this measure in a non-trial setting.",2021,"rSS-II was higher in older women with more co-morbidities, but not different by race-ethnicity.
","['165 patients from a single center urban US registry (n\u2009=\u20091208) presenting for primary percutaneous coronary intervention of STEMI and treated for 3-vessel or left main and any combination of 0, 1, 2 or 3-vessel disease', 'The median age was 62\u2009years (IQR 52-70), 29.1% women, 44.9% Hispanic/Latino and 19.4% non-Hispanic Black']",['Percutaneous Coronary Intervention With Taxus and Cardiac Surgery'],"['death or all-cause readmission', 'death or cardiovascular disease readmission', 'SYNTAX)- II (SS-II) score']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1208.0,0.131743,"rSS-II was higher in older women with more co-morbidities, but not different by race-ethnicity.
","[{'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Bortnick', 'Affiliation': 'Department of Medicine, Division of Cardiology Department of Medicine, Division of Geriatrics, Montefiore Medical Center Albert Einstein College of Medicine, Bronx, New York Department of Medicine, Cardiology Section, San Francisco Veterans Affairs Health Care System, and Department of Medicine, University of California San Francisco, San Francisco, California Division of Cardiology, Department of Medicine, MedStar Washington Hospital Center and Georgetown University, Washington DC Sorin Medical, P.C., Brooklyn Division of Cardiovascular Medicine, Department of Medicine, University at Buffalo, Buffalo, New York Department of Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio Department of Medicine, Division of Cardiology, New York Presbyterian Hospital, New York Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Sanyog G', 'Initials': 'SG', 'LastName': 'Shitole', 'Affiliation': ''}, {'ForeName': 'Hayder', 'Initials': 'H', 'LastName': 'Hashim', 'Affiliation': ''}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Khullar', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weinreich', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Seibert', 'Affiliation': ''}, {'ForeName': 'Judah', 'Initials': 'J', 'LastName': 'Rauch', 'Affiliation': ''}, {'ForeName': 'Giora', 'Initials': 'G', 'LastName': 'Weisz', 'Affiliation': ''}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Kizer', 'Affiliation': ''}]",Coronary artery disease,['10.1097/MCA.0000000000001074']
1317,34052007,"Effects of Ivermectin in Patients With COVID-19: A Multicenter, Double-blind, Randomized, Controlled Clinical Trial.","PURPOSE


Given the coronavirus disease 2019 (COVID-19) pandemic, there is a global urgency to discover an effective treatment for patients withthis disease. This study aimed to evaluate the effects of the widely used antiparasitic drug ivermectin on outcomes in patients with COVID-19.
METHODS


In this randomized, double-blind clinical trial, patients with COVID-19 admitted to 2 referral tertiary hospitals in Mazandaran, Iran, were randomly divided into 2 groups: intervention and control. In addition to standard treatment for COVID-19, the intervention group received a single weight-based dose (0.2 mg/kg) of ivermectin; the control group received the standard of care. Demographic, clinical, laboratory, and imaging data from participants were recorded at baseline. Patients were assessed daily for symptoms and disease progression. The primary clinical outcome measures were the durations of hospital stay, fever, dyspnea, and cough; and overall clinical improvement.
FINDINGS


Sixty-nine patients were enrolled (mean [SD] ages: ivermectin, 47.63 [22.20] years; control, 45.18 [23.11] years; P = 0.65). Eighteen patients (51.4%) in the ivermectin group and 18 (52.9%) in control group were male (P = 0.90). The mean durations of dyspnea were 2.6 (0.4) days in the ivermectin group and 3.8 (0.4) days in the control group (P = 0.048). Also, persistent cough lasted for 3.1 (0.4) days in the ivermectin group compared to 4.8 (0.4) days in control group (PP = 0.019). The mean durations of hospital stay were 7.1 (0.5) days versus 8.4 (0.6) days in the ivermectin and control groups, respectively (P = 0.016). Also, the frequency of lymphopenia decreased to 14.3% in the ivermectin group and did not change in the control group (P = 0.007).
IMPLICATIONS


A single dose of ivermectin was well-tolerated in symptomatic patients with COVID-19, and important clinical features of COVID-19 were improved with ivermectin use, including dyspnea, cough, and lymphopenia. Further studies with larger sample sizes, different drug dosages, dosing intervals and durations, especially in different stages of the disease, may be useful in understanding the potential clinical benefits ivermectin. Iranian Registry of Clinical Trials identifier: IRCT20111224008507N3.",2021,"Also, the frequency of lymphopenia decreased to 14.3% in the ivermectin group and did not change in the control group (P = 0.007).
","['patients with COVID-19 admitted to 2 referral tertiary hospitals in Mazandaran, Iran', 'patients withthis disease', 'Sixty-nine patients were enrolled (mean [SD] ages: ivermectin, 47.63 [22.20] years; control, 45.18 [23.11] years; P\xa0=\xa00.65', 'Patients With COVID-19', 'patients with COVID-19']","['intervention and control', 'Ivermectin', 'ivermectin']","['frequency of lymphopenia', 'mean durations of dyspnea', 'symptoms and disease progression', 'mean durations of hospital stay', 'durations of hospital stay, fever, dyspnea, and cough; and overall clinical improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517471', 'cui_str': '0.65'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",69.0,0.285314,"Also, the frequency of lymphopenia decreased to 14.3% in the ivermectin group and did not change in the control group (P = 0.007).
","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Shahbaznejad', 'Affiliation': 'Pediatric Infectious Diseases Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Davoudi', 'Affiliation': 'Antimicrobial Resistance Research Center, Department of Infectious Diseases, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Gohar', 'Initials': 'G', 'LastName': 'Eslami', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Cardiovascular Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Markowitz', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, Center for Pharmacogenomics and Precision Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Navaeifar', 'Affiliation': 'Pediatric Infectious Diseases Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Pediatric Infectious Diseases Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Faeze Sadat', 'Initials': 'FS', 'LastName': 'Movahedi', 'Affiliation': 'Student Research Committee, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Rezai', 'Affiliation': 'Pediatric Infectious Diseases Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: drmsrezaii@yahoo.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2021.04.007']
1318,34057133,"Comparative effects of different manual techniques on electromyography activity, kinematics, and muscle force in limited ankle dorsiflexion syndrome.","BACKGROUND


Although the instrument-assisted manual (IM) technique has been widely utilised to improve soft tissue and joint mobility, its therapeutic benefits and underlying neuromechanical mechanisms remain unknown compared to those of conventional static stretching (SS) and hold-relax (HR) manual techniques.
OBJECTIVE


This study aimed to compare the effects of the SS, HR, and IM techniques on muscle activity, kinematics, and strength during deep squatting in limited ankle dorsiflexion (DF) syndrome.
METHODS


This was a cross-sectional randomised controlled study including 39 adults divided into three groups: SS group: 13, HR group: 13, IM group: 13. Outcome measures were the tibialis anterior (TA): gastrocnemius (GCM) balance ratio and ankle, knee, hip and thoracolumbar junction angles. TA muscle strength was analysed to evaluate the limited ankle DF. Analysis of variance was performed, with P< 0.05.
RESULTS


The TA:GCM balance ratio, ranges of motion of ankle DF and knee flexion, and TA muscle strength in the IM group improved significantly compared to that in either the SS group or HR group (P< 0.05).
CONCLUSIONS


Our novel results demonstrated that IM was most effective in normalising TA:GCM balance, ankle DF range of motion, and TA muscle strength during deep squatting in adults with limited ankle DF.",2021,"The TA:GCM balance ratio, ranges of motion of ankle DF and knee flexion, and TA muscle strength in the IM group improved significantly compared to that in either the SS group or HR group (P< 0.05).
","['39 adults divided into three groups: SS group: 13, HR group: 13, IM group: 13', 'limited ankle dorsiflexion syndrome', 'normalising TA', 'adults with limited ankle DF']","['SS, HR, and IM techniques', 'conventional static stretching (SS']","['electromyography activity, kinematics, and muscle force', 'muscle activity, kinematics, and strength', 'TA:GCM balance ratio, ranges of motion of ankle DF and knee flexion, and TA muscle strength', 'tibialis anterior (TA): gastrocnemius (GCM) balance ratio and ankle, knee, hip and thoracolumbar junction angles', 'GCM balance, ankle DF range of motion, and TA muscle strength', 'TA muscle strength']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",39.0,0.0217678,"The TA:GCM balance ratio, ranges of motion of ankle DF and knee flexion, and TA muscle strength in the IM group improved significantly compared to that in either the SS group or HR group (P< 0.05).
","[{'ForeName': 'Jihoon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Sports Movement Artificial-Intelligence Robotics Technology (SMART) Institute, Department of Physical Therapy, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Chanhee', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Sports Movement Artificial-Intelligence Robotics Technology (SMART) Institute, Department of Physical Therapy, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Youngjoo', 'Initials': 'Y', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, Cheju Halla University, Jeju, Korea.'}, {'ForeName': 'Joshua Sung H', 'Initials': 'JSH', 'LastName': 'You', 'Affiliation': 'Sports Movement Artificial-Intelligence Robotics Technology (SMART) Institute, Department of Physical Therapy, Yonsei University, Wonju, Korea.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200257']
1319,34057129,The clinical effects of mobilization with passive ankle dorsiflexion using a passive ankle dorsiflexion apparatus on older patients with knee osteoarthritis: A randomized trial.,"BACKGROUND


Active exercise is the only proven effective intervention for knee osteoarthritis (OA). The addition of manual therapy has shown to improve outcome of exercises. Passive mobilization with submaximal bilateral passive ankle dorsiflexion was examined in a double-blinded randomized controlled clinical trial. A passive ankle dorsiflexion apparatus was used to standardize the frequency, range of motion, and duration parameters.
OBJECTIVES


The purpose of the study was to determine whether a simple standardised mobilization technique could be incorporated as a safe and unsupervised conservative treatment for knee OA.
METHODS


In total, 73 participants were randomly assigned to the experimental (n= 37) or control group (n= 36). All participants performed active exercises and received six sessions of 10-minute dorsiflexion intervention, either real or sham, for two weeks. Pre- and post-experimental assessments for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analog scale (VAS) for pain, and range of motion of the knee were conducted.
RESULTS


Results were analyzed using two-way repeated measures analysis of variance and Independent-Samples Mann-Whitney U Test. The mean score of WOMAC for the experimental and control groups changed from 31.84 to 18.19 and 34.74 to 21.06, respectively, after the intervention. The VAS also showed significant improvements. Significant improvements were observed in WOMAC in both groups after the intervention; however, differences between the groups were not statistically significant.
CONCLUSIONS


Exercise with either 30∘ or 5∘ of passive dorsiflexion yielded favorable clinical effects. Although submaximal bilateral ankle dorsiflexion was proven to be safe for elderly participants with osteoarthritis of the knee, whether it provided extra benefits to exercises alone was unclear. Further research is required to determine the effectiveness of dorsiflexion and optimal range of mobilization.",2021,"Although submaximal bilateral ankle dorsiflexion was proven to be safe for elderly participants with osteoarthritis of the knee, whether it provided extra benefits to exercises alone was unclear.","['older patients with knee osteoarthritis', 'elderly participants with osteoarthritis of the knee', '73 participants']","['mobilization with passive ankle dorsiflexion using a passive ankle dorsiflexion apparatus', 'active exercises and received six sessions of 10-minute dorsiflexion intervention, either real or sham', 'Passive mobilization with submaximal bilateral passive ankle dorsiflexion', 'submaximal bilateral ankle dorsiflexion']","['mean score of WOMAC', 'WOMAC', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analog scale (VAS) for pain, and range of motion of the knee']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0419117', 'cui_str': 'Active exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",73.0,0.163643,"Although submaximal bilateral ankle dorsiflexion was proven to be safe for elderly participants with osteoarthritis of the knee, whether it provided extra benefits to exercises alone was unclear.","[{'ForeName': 'Kerry W Y', 'Initials': 'KWY', 'LastName': 'Fung', 'Affiliation': 'Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Daniel H K', 'Initials': 'DHK', 'LastName': 'Chow', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'W C', 'Initials': 'WC', 'LastName': 'Shae', 'Affiliation': 'Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191799']
1320,34059080,"Safety and efficacy of umbilical cord-derived Wharton's jelly compared to hyaluronic acid and saline for knee osteoarthritis: study protocol for a randomized, controlled, single-blind, multi-center trial.","BACKGROUND


Osteoarthritis (OA) is the most common joint disorder in the United States of America (USA) with a fast-rising prevalence. Current treatment modalities are limited, and total knee replacement surgeries have shown disadvantages, especially for grade II/III OA. The interest in the use of biologics, including umbilical cord (UC)-derived Wharton's jelly (WJ), has grown in recent years. The results from a preliminary study demonstrated the presence of essential components of regenerative medicine, namely growth factors, cytokines, hyaluronic acid (HA), and extracellular vesicles, including exosomes, in WJ. The proposed study aims to evaluate the safety and efficacy of intra-articular injection of UC-derived WJ for the treatment of knee OA symptoms.
METHODS


A randomized, controlled, single-blind, multi-center, prospective study will be conducted in which the safety and efficacy of intra-articular administration of UC-derived WJ are compared to HA (control) and saline (placebo control) in patients suffering from grade II/III knee OA. A total of 168 participants with grade II or III knee OA on the KL scale will be recruited across 53 sites in the USA with 56 participants in each arm and followed for 1 year post-injection. Patient satisfaction, Numeric Pain Rating Scale, Knee Injury and Osteoarthritis Outcome Score, 36-Item Short Form Survey (SF-36), and 7-point Likert Scale will be used to assess the participants. Physical exams, X-rays, and MRI with Magnetic Resonance Observation of Cartilage Repair Tissue score will be used to assess improvement in associated anatomy.
DISCUSSION


The study results will provide valuable information into the safety and efficacy of intra-articular administration of Wharton's jelly for grade II/III knee osteoarthritis. The results of this study will also add to the treatment options available for grade II/III OA as well as help facilitate the development of a more focused treatment strategy for patients.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04711304 . Registered on January 15, 2021.",2021,The study results will provide valuable information into the safety and efficacy of intra-articular administration of Wharton's jelly for grade II/III knee osteoarthritis.,"['knee osteoarthritis', '168 participants with grade II or III knee OA on the KL scale will be recruited across 53 sites in the USA with 56 participants in each arm and followed for 1 year post-injection', 'patients suffering from grade II/III knee OA', 'grade II/III knee osteoarthritis', 'knee OA symptoms']","['UC-derived WJ', 'HA (control) and saline (placebo control', 'hyaluronic acid and saline', ""umbilical cord-derived Wharton's jelly""]","['Safety and efficacy', 'safety and efficacy', 'presence of essential components of regenerative medicine, namely growth factors, cytokines, hyaluronic acid (HA), and extracellular vesicles, including exosomes, in WJ', 'Patient satisfaction, Numeric Pain Rating Scale, Knee Injury and Osteoarthritis Outcome Score, 36-Item Short Form Survey (SF-36), and 7-point Likert Scale']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0230987', 'cui_str': ""Structure of Wharton's jelly""}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1257974', 'cui_str': 'Regenerative medicine'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2350332', 'cui_str': 'Exosomes'}, {'cui': 'C0230987', 'cui_str': ""Structure of Wharton's jelly""}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",168.0,0.0950468,The study results will provide valuable information into the safety and efficacy of intra-articular administration of Wharton's jelly for grade II/III knee osteoarthritis.,"[{'ForeName': 'Ashim', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'BioIntegrate, Lawrenceville, GA, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Maffulli', 'Affiliation': 'Department of Musculoskeletal Disorders, School of Medicine and Surgery, University of Salerno, Fisciano, Italy.'}, {'ForeName': 'Hugo C', 'Initials': 'HC', 'LastName': 'Rodriguez', 'Affiliation': 'Future Biologics, Lawrenceville, GA, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Carson', 'Affiliation': 'Department of Orthopaedic Surgery, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Randa A', 'Initials': 'RA', 'LastName': 'Bascharon', 'Affiliation': 'Orthopedic & Sports Medicine Institute of Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Delfino', 'Affiliation': 'Southern Illinois University, School of Medicine, Springfield, IL, USA.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Levy', 'Affiliation': 'BioIntegrate, Lawrenceville, GA, USA.'}, {'ForeName': 'Saadiq F', 'Initials': 'SF', 'LastName': 'El-Amin', 'Affiliation': 'BioIntegrate, Lawrenceville, GA, USA. dr.saadiqelamin@gmail.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-021-02475-6']
1321,34059401,Low Dose Lithium Treatment of Behavioral Complications in Alzheimer's Disease: Lit-AD Randomized Clinical Trial.,"BACKGROUND


A case series suggested efficacy for lithium to treat agitation in dementia, but no placebo-controlled trials have been conducted.
OBJECTIVES


To evaluate low-dose lithium treatment of agitation in Alzheimer's disease (AD).
METHOD


In a four-site trial, patients with AD and agitation/aggression score ≥4 on the Neuropsychiatric Inventory (NPI) were randomized, double-blind, to lithium carbonate 150-600 mg daily or placebo for 12 weeks. Primary efficacy outcome was change in NPI agitation/aggression; secondary efficacy outcome was treatment response (30% reduction in NPI score for agitation/aggression plus psychosis and a Clinical Global Impression (CGI) score of much or very much improved). Safety profile of lithium was assessed.
RESULTS


Fifty-eight of 77 patients (75.3%) completed the trial. In linear mixed effects model analyses, lithium was not significantly superior to placebo for agitation/aggression. Proportion of responders was 31.6% on lithium and 17.9% on placebo (χ 2 =1.26, p = 0.26). Moderate or marked improvement (CGI) was greater on lithium (10/38=36.8%) than placebo (0/39=0%, Fisher's exact test p <0.001). In exploratory analyses, improvement on lithium was greater than placebo on NPI delusions and irritability/lability (p's<0.05). Lithium showed greater reduction than placebo in patients with high Young Mania Rating Scale scores (β=5.06; 95%CI,1.18 to 8.94, p = 0.01). Oral dose and serum levels demonstrated similar associations with efficacy outcomes. Lithium did not differ significantly from placebo on safety outcomes.
CONCLUSIONS


Low-dose lithium was not efficacious in treating agitation but was associated with global clinical improvement and excellent safety. A larger trial may be warranted of likely lithium-responsive behavioral symptoms that overlap with mania.",2021,"In exploratory analyses, improvement on lithium was greater than placebo on NPI delusions and irritability/lability (p's<0.05).","['patients with AD and agitation/aggression score ≥4 on the Neuropsychiatric Inventory (NPI', ""Alzheimer's Disease"", ""Alzheimer's disease (AD"", 'Fifty-eight of 77 patients (75.3%) completed the trial']","['Low Dose Lithium', 'lithium', 'Lithium', 'lithium carbonate 150-600 mg daily or placebo', 'placebo']","['NPI agitation/aggression; secondary efficacy outcome', 'NPI score for agitation/aggression plus psychosis and a Clinical Global Impression (CGI) score of much or very much improved', 'safety outcomes', 'NPI delusions and irritability/lability', 'Moderate or marked improvement (CGI', 'global clinical improvement and excellent safety', 'Young Mania Rating Scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0085217', 'cui_str': 'Lithium Carbonate'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}]",,0.577671,"In exploratory analyses, improvement on lithium was greater than placebo on NPI delusions and irritability/lability (p's<0.05).","[{'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY. Electronic address: dpd3@cumc.columbia.edu.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Crocco', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}, {'ForeName': 'Brent P', 'Initials': 'BP', 'LastName': 'Forester', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}, {'ForeName': 'Mustafa M', 'Initials': 'MM', 'LastName': 'Husain', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}, {'ForeName': 'Seonjoo', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}, {'ForeName': 'Ipsit V', 'Initials': 'IV', 'LastName': 'Vahia', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Andrews', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Simon-Pearson', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Imran', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Luca', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Huey', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Deliyannides', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}, {'ForeName': 'Gregory H', 'Initials': 'GH', 'LastName': 'Pelton', 'Affiliation': ""Division of Geriatric Psychiatry (DPD, LSP, EDH, DAD, GHP), New York State Psychiatric Institute, NY; Department of Psychiatry (DPD, SL, HA, EDH, BAD, GHP), Columbia University Medical Center, NY; Department of Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, (DPD, EDH), Columbia University Medical Center, NY; Center for Cognitive Neuroscience and Aging, Department of Psychiatry and Behavioral Sciences (EC, LL), University of Miami Miller School of Medicine Miami, FL; Division of Geriatric Psychiatry (BPF, IVV), McLean Hospital, Harvard Medical School, MA; Departments of Psychiatry and Neurology (MMH, NI), University of Texas Southwestern Medical Center, TX; Mental Health Data Science, Department of Psychiatry (SL, HA), Columbia University Medical Center and New York State Psychiatric Institute, NY.""}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2021.04.014']
1322,34077818,Plasma androgen receptor and response to adapted and standard docetaxel regimen in castration-resistant prostate cancer: A multicenter biomarker study.,"BACKGROUND


Plasma AR status has been identified as a potential biomarker of response in metastatic castration-resistant prostate cancer (mCRPC) patients receiving docetaxel or AR-targeted therapies. However, the relevance of plasma AR in the overall management of CRPC patients receiving different docetaxel doses is unknown.
PATIENTS AND METHODS


This was a multi-institution study of associations between baseline plasma AR copy number status, assessed by droplet digital PCR, and outcome in 325 mCRPC patients receiving docetaxel at standard or adapted regimen at the discretion of the treating physician. Upon analysis, patients were assigned randomly to either a training (n = 217) or validation (n = 108) cohort.
RESULTS


In the training cohort, AR-gained patients treated with adapted docetaxel regimen had a significantly worse median progression-free survival (PFS) (3.8 vs 6.3 months, hazard ratio [HR] 2.58, 95% confidence interval [CI] 1.34-4.95, p < 0.0001), median overall survival (10.8 vs 20.6 months, HR 1.98, 95% CI 1.09-3.62, p = 0.0064) and PSA response (PSA > -50%: odds ratio 4.88 95%CI 1.55-14.32, p = 0.013) as compared to plasma AR normal patients. These findings were all confirmed in the validation cohort. However, in patients treated with standard docetaxel regimen, these differences were not seen. The interaction between AR CN status and dose reduction of docetaxel was considered as independent factor for PFS in both the training and validation cohort (HR 2.84, 95% CI 1.41-5.73, p = 0.003, and HR 4.79, 95% CI 1.79-12.82, p = 0.002).
CONCLUSION


Despite the retrospective non-randomised design of this study, our hypothesis-generating findings could suggest plasma AR as a potential biomarker for optimal docetaxel timing and dose in mCRPC patients. Prospective trials are warranted.",2021,"In the training cohort, AR-gained patients treated with adapted docetaxel regimen had a significantly worse median progression-free survival (PFS) (3.8 vs 6.3 months, hazard ratio [HR]","['mCRPC patients', '325 mCRPC patients receiving docetaxel at standard or adapted regimen at the discretion of the treating physician', 'metastatic castration-resistant prostate cancer (mCRPC) patients receiving', 'castration-resistant prostate cancer']","['docetaxel', 'adapted docetaxel', 'standard docetaxel']","['median progression-free survival (PFS', 'median overall survival', 'PSA response', 'hazard ratio [HR']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",325.0,0.11222,"In the training cohort, AR-gained patients treated with adapted docetaxel regimen had a significantly worse median progression-free survival (PFS) (3.8 vs 6.3 months, hazard ratio [HR]","[{'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Conteduca', 'Affiliation': 'IRCCS Istituto Romagnolo per Lo Studio Dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy. Electronic address: vincenza.conteduca@irst.emr.it.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wetterskog', 'Affiliation': 'University College London Cancer Institute, London, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Castro', 'Affiliation': 'Prostate Cancer Research Unit, Spanish National Cancer Research Centre.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Scarpi', 'Affiliation': 'IRCCS Istituto Romagnolo per Lo Studio Dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Romero-Laorden', 'Affiliation': 'Medical Oncology Department, Hospital Universitario La Princesa, Madrid, Spain.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Gurioli', 'Affiliation': 'IRCCS Istituto Romagnolo per Lo Studio Dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Jayaram', 'Affiliation': 'University College London Cancer Institute, London, UK.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Lolli', 'Affiliation': 'IRCCS Istituto Romagnolo per Lo Studio Dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Schepisi', 'Affiliation': 'IRCCS Istituto Romagnolo per Lo Studio Dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wingate', 'Affiliation': 'University College London Cancer Institute, London, UK.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Casadei', 'Affiliation': 'IRCCS Istituto Romagnolo per Lo Studio Dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Lozano', 'Affiliation': 'Centro Nacional Investigaciones Oncologica, Madrid, Spain.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Brighi', 'Affiliation': 'IRCCS Istituto Romagnolo per Lo Studio Dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Isabel M', 'Initials': 'IM', 'LastName': 'Aragón', 'Affiliation': 'Genitourinary Translational Research Unit, Institute of Biomedical Research, Malaga, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Marin-Aguilera', 'Affiliation': 'Medical Oncology Department, IDIBAPS, Hospital Clínico y Provincial, Barcelona, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gonzalez-Billalabeitia', 'Affiliation': 'Department of Hematology & Medical Oncology, Hospital Universitario Morales Meseguer, IMIB-Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Mellado', 'Affiliation': 'Medical Oncology Department, IDIBAPS, Hospital Clínico y Provincial, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': 'Prostate Cancer Research Unit, Spanish National Cancer Research Centre.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'University College London Cancer Institute, London, UK. Electronic address: g.attard@ucl.ac.uk.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'IRCCS Istituto Romagnolo per Lo Studio Dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.04.025']
1323,34093444,Levothyroxine Treatment and Cardiovascular Outcomes in Older People With Subclinical Hypothyroidism: Pooled Individual Results of Two Randomised Controlled Trials.,"Background


The cardiovascular effects of treating older adults with subclinical hypothyroidism (SCH) are uncertain. Although concerns have been raised regarding a potential increase in cardiovascular side effects from thyroid hormone replacement, undertreatment may also increase the risk of cardiovascular events, especially for patients with cardiovascular disease (CVD).
Objective


To determine the effects of levothyroxine treatment on cardiovascular outcomes in older adults with SCH.
Methods


Combined data of two parallel randomised double-blind placebo-controlled trials TRUST (Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial) and IEMO80+ (the Institute for Evidence-Based Medicine in Old Age 80-plus thyroid trial) were analysed as one-stage individual participant data. Participants aged ≥65 years for TRUST (n=737) and ≥80 years for IEMO80+ (n=105) with SCH, defined by elevated TSH with fT4 within the reference range, were included. Participants were randomly assigned to receive placebo or levothyroxine, with titration of the dose until TSH level was within the reference range. Cardiovascular events and cardiovascular side effects of overtreatment (new-onset atrial fibrillation and heart failure) were investigated, including stratified analyses according to CVD history and age.
Results


The median [IQR] age was 75.0 [69.7-81.1] years, and 448 participants (53.2%) were women. The mean TSH was 6.38± SD 5.7 mIU/L at baseline and decreased at 1 year to 5.66 ± 3.3 mIU/L in the placebo group, compared with 3.66 ± 2.1 mIU/L in the levothyroxine group (p<0.001), at a median dose of 50 μg. Levothyroxine did not significantly change the risk of any of the prespecified cardiovascular outcomes, including cardiovascular events (HR 0.74 [0.41-1.25]), atrial fibrillation (HR 0.69 [0.32-1.52]), or heart failure (0.41 [0.13-1.35]), or all-cause mortality (HR 1.28 [0.54-3.03]), irrespective of history of CVD and age.
Conclusion


Treatment with levothyroxine did not significantly change the risk of cardiovascular outcomes in older adults with subclinical hypothyroidism, irrespective of a history of cardiovascular disease and age.
Clinical Trial Registration


[ClinicalTrials.gov], identifier [NCT01660126] (TRUST); Netherlands Trial Register: NTR3851 (IEMO80+).",2021,"Levothyroxine did not significantly change the risk of any of the prespecified cardiovascular outcomes, including cardiovascular events (HR 0.74 [0.41-1.25]), atrial fibrillation (HR 0.69 [0.32-1.52]), or heart failure (0.41 [0.13-1.35]), or all-cause mortality (HR 1.28 [0.54-3.03]), irrespective of history of CVD and age.
","['Older People With Subclinical Hypothyroidism', 'The median [IQR] age was 75.0 [69.7-81.1] years, and 448 participants (53.2%) were women', 'Participants aged ≥65 years for TRUST (n=737) and ≥80 years for IEMO80+ (n=105) with SCH, defined by elevated TSH with fT4 within the reference range, were included', 'older adults with SCH', 'Untreated older adults with Subclinical hypothyroidism - a randomised', 'older adults with subclinical hypothyroidism (SCH', 'older adults with subclinical hypothyroidism', 'patients with cardiovascular disease (CVD']","['placebo-controlled trials TRUST ', 'Thyroid hormone Replacement', 'levothyroxine', 'placebo or levothyroxine', 'IEMO80', 'placebo', 'Levothyroxine']","['risk of cardiovascular outcomes', 'Cardiovascular events and cardiovascular side effects of overtreatment (new-onset atrial fibrillation and heart failure', 'heart failure', 'cardiovascular outcomes', 'cardiovascular events', 'Cardiovascular Outcomes', 'mean TSH', 'atrial fibrillation']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0586553', 'cui_str': 'Raised TSH level'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C4046039', 'cui_str': 'Overtreatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]",,0.586777,"Levothyroxine did not significantly change the risk of any of the prespecified cardiovascular outcomes, including cardiovascular events (HR 0.74 [0.41-1.25]), atrial fibrillation (HR 0.69 [0.32-1.52]), or heart failure (0.41 [0.13-1.35]), or all-cause mortality (HR 1.28 [0.54-3.03]), irrespective of history of CVD and age.
","[{'ForeName': 'Laurien E', 'Initials': 'LE', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Rudi G J', 'Initials': 'RGJ', 'LastName': 'Westendorp', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Du Puy', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Rosalinde K E', 'Initials': 'RKE', 'LastName': 'Poortvliet', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': ""O'Keeffe"", 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Olaf M', 'Initials': 'OM', 'LastName': 'Dekkers', 'Affiliation': 'Department of Endocrinology and Metabolic Disorders, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Blum', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetology, Nutrition and Therapeutic Education, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': 'Quinn', 'Affiliation': 'The Academic Section of Geriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Faculty of Medicine, Glasgow, United\xa0Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Trompet', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Wendy P J', 'Initials': 'WPJ', 'LastName': 'den Elzen', 'Affiliation': 'Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Mooijaart', 'Affiliation': 'Department of Internal Medicine, Section of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, Netherlands.'}]",Frontiers in endocrinology,['10.3389/fendo.2021.674841']
1324,34092590,Is it appropriate to use external loads during side-lying hip abduction exercise for weakened gluteus medius?,"BACKGROUND


Side-lying hip abduction exercise could be beneficial to improve the neuromuscular control of the hip abductor; however, there has been limited information available to determine the exercise load during the exercise.
OBJECTIVE


This study aimed to demonstrate the effects of using external loads on the hip abductor muscles during side-lying hip abduction exercises in females with gluteus medius (GM) weakness.
METHODS


This study enrolled 24 females with weakness in the GM. Electromyographic (EMG) data of the quadratus lumborum (QL) and GM muscles were recorded during the exercise under three load conditions: no-load, external load-1 (3% of body weight), and external load-2 (5% of body weight).
RESULTS


During the exercise, the EMG activities of the QL were significantly different under all three conditions (p< 0.05), with greater activity observed in the external load-2 condition (92.05 ± 65.93% maximal voluntary isometric contraction [MVIC]) as compared to the others, and in the external load-1 condition (82.47 ± 57.36% MVIC) as compared to the no-load condition (48.94 ± 45.09% MVIC). Furthermore, the GM/QL ratios showed significant differences between no-load (1.78 ± 1.47) and external load-1 conditions (0.93 ± 0.60), and between no-load and external load-2 (0.85 ± 0.45) conditions (p< 0.05).
CONCLUSION


These findings suggest that greater load could be a factor to increase the QL activity during the exercise in females with weakened GM.",2021,"During the exercise, the EMG activities of the QL were significantly different under all three conditions (p< 0.05), with greater activity observed in the external load-2 condition (92.05 ± 65.93% maximal voluntary isometric contraction [MVIC]) as compared to the others, and in the external load-1 condition (82.47 ± 57.36% MVIC) as compared to the no-load condition (48.94 ± 45.09% MVIC).","['24 females with weakness in the GM', 'females with gluteus medius (GM) weakness', 'females with weakened GM']",['side-lying hip abduction exercises'],"['EMG activities of the QL', 'external load-1 conditions', 'Electromyographic (EMG) data of the quadratus lumborum (QL) and GM muscles', 'QL activity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0224425', 'cui_str': 'Structure of gluteus medius muscle'}]","[{'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0224425', 'cui_str': 'Structure of gluteus medius muscle'}]",24.0,0.0411903,"During the exercise, the EMG activities of the QL were significantly different under all three conditions (p< 0.05), with greater activity observed in the external load-2 condition (92.05 ± 65.93% maximal voluntary isometric contraction [MVIC]) as compared to the others, and in the external load-1 condition (82.47 ± 57.36% MVIC) as compared to the no-load condition (48.94 ± 45.09% MVIC).","[{'ForeName': 'Soo-Jin', 'Initials': 'SJ', 'LastName': 'Nam', 'Affiliation': 'Operation and Support Team, CJ Corporation, Seoul, South Korea.'}, {'ForeName': 'Duck-Won', 'Initials': 'DW', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Cheongju University, Cheongju, South Korea.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200108']
1325,34092587,Fascial treatment versus manual therapy (HVLA) in patients with chronic neck pain: A randomized controlled trial.,"BACKGROUND


Chronic neck pain (CNP) is a common health problem in western industrialized nations. In recent years, the fascial tissue has attracted the attention of therapists, and a treatment of the fasciae promises to be a meaningful approach in the therapy of patients with CNP.
OBJECTIVE


The aim of this study was to investigate the effectiveness of a fascial treatment (FT) compared to manual therapy (MT) and to no intervention (control group, CG) in patients with CNP.
METHODS


Sixty participants with CNP were randomized into three groups. Primary outcome parameters were pain intensity as measured by the visual analogue scale (VAS), and severity of illness as measured by the Neck Pain and Disability Scale (NPAD). Secondary outcome parameter was the range of motion (ROM) of the cervical spine.
RESULTS


Repeated measures t-tests demonstrated significant decreases with medium to large effect sizes for the FT (VAS: dR⁢M= 1.14; NPAD: dR⁢M= 0.51) and for the MT (VAS: dR⁢M= 1.15; NPAD: dR⁢M= 0.72).
CONCLUSION


Our results confirmed the effectiveness of MT on pain and severity of illness in the treatment of patients suffering from CNP. Furthermore, the results demonstrated the effectiveness and clinical relevance of FT for this population.",2021,"RESULTS


Repeated measures t-tests demonstrated significant decreases with medium to large effect sizes for the FT (VAS: dR⁢M= 1.14; NPAD: dR⁢M= 0.51) and for the MT (VAS: dR⁢M= 1.15; NPAD:","['patients with chronic neck pain', 'Chronic neck pain (CNP', 'patients suffering from CNP', 'Sixty participants with CNP', 'patients with CNP']","['fascial treatment (FT', 'MT', 'manual therapy (MT) and to no intervention (control group, CG', 'Fascial treatment versus manual therapy (HVLA']","['pain intensity as measured by the visual analogue scale (VAS), and severity of illness as measured by the Neck Pain and Disability Scale (NPAD', 'pain and severity of illness', 'range of motion (ROM) of the cervical spine']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}]",60.0,0.0481707,"RESULTS


Repeated measures t-tests demonstrated significant decreases with medium to large effect sizes for the FT (VAS: dR⁢M= 1.14; NPAD: dR⁢M= 0.51) and for the MT (VAS: dR⁢M= 1.15; NPAD:","[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Brück', 'Affiliation': 'Praxis für Osteopathie und Naturheilkunde, Geestland, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Jacobi', 'Affiliation': 'Faszium GbR, Altenholz, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schmidt', 'Affiliation': 'Department of General Practice, University Medical Center Göttingen, Göttingen, Germany.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191731']
1326,34091741,Evaluation of a novel technique of bladder neck and supramontanal sparing ejaculatory preserving transurethral prostatectomy.,"PURPOSE


Transurethral resection of the prostate (TURP) can achieve highly satisfying symptomatic and functional outcomes but the loss of antegrade ejaculation represents a major reason for the avoidance of surgical treatment to preserve normal ejaculation and paternity. We present a novel technique to duplicate both bladder neck sparing and supramontanal sparing with resection of apical tissues to improve voiding and antegrade ejaculation.
METHODS


A prospective study done from June 2018 to June 2020 on 60 consecutive male patients with normal sexual activity diagnosed with benign prostatic enlargement. These patients were randomized into two groups; 30 patients in each group. Group 1 underwent bladder neck and supramontanal sparing ejaculatory preserving transurethral bipolar resection of prostate (ep-TUBRP) and Group 2 underwent classic transurethral bipolar resection of prostate (c-TUBRP). All patients were evaluated pre- and postoperatively (after 3 months) using IPSS, Qmax and by IIEF-5.
RESULTS


In both groups, there were significant improvements 3 months postoperative in Qmax [7.97 mL/s to 18.47 mL/s (group A) and 7.8 to 20.7 mL/s (group B)] and in micturition symptoms according to reductions in IPSS score [24 to 7.5 (group A) and 25 to 8.5 (group B)]. IIEF-5 score improved significantly from a mean of 12.9 to 18.6 (group A) and from 11.6 to 16.4 (group B). Antegrade ejaculation reported in 80% of patients in group A and 27% in group B which was significant (p < 0.001). Postoperative period did not reveal acute urinary retention, stress urinary incontinence, or serious adverse events.
CONCLUSIONS


On short-term results, bladder neck and supramontanal ejaculation preserving transurethral bipolar resection of the prostate is superior to classic TURP in preservation of forward ejaculation with comparable efficacy in micturition parameters.",2021,"In both groups, there were significant improvements 3 months postoperative in Qmax [7.97 mL",['A prospective study done from June 2018 to June 2020 on 60 consecutive male patients with normal sexual activity diagnosed with benign prostatic enlargement'],"['bladder neck sparing and supramontanal sparing with resection of apical tissues', 'novel technique of bladder neck and supramontanal sparing ejaculatory preserving transurethral prostatectomy', 'mL', 'Transurethral resection of the prostate (TURP', 'bladder neck and supramontanal ejaculation preserving transurethral bipolar resection', 'bladder neck and supramontanal sparing ejaculatory preserving transurethral bipolar resection of prostate (ep-TUBRP) and Group 2 underwent classic transurethral bipolar resection of prostate (c-TUBRP']","['Antegrade ejaculation', 'IIEF-5 score', 'IPSS score', 'acute urinary retention, stress urinary incontinence, or serious adverse events']","[{'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0426732', 'cui_str': 'Large prostate'}]","[{'cui': 'C0227716', 'cui_str': 'Structure of neck of urinary bladder'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439658', 'cui_str': 'Classic'}]","[{'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.0153968,"In both groups, there were significant improvements 3 months postoperative in Qmax [7.97 mL","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elshazly', 'Affiliation': 'Department of Urology, Menoufia University Hospitals, Shebeen el kom, Egypt.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Sultan', 'Affiliation': 'Department of Urology, Menoufia University Hospitals, Shebeen el kom, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Shaban', 'Affiliation': 'Department of Urology, Nasser Institute for Research and Treatment, Cairo, Egypt.'}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Zanaty', 'Affiliation': 'Department of Urology, Menoufia University Hospitals, Shebeen el kom, Egypt. drfouad80@gmail.com.'}]",World journal of urology,['10.1007/s00345-021-03752-z']
1327,34096759,Initial evaluation of domain-specific episodic future thinking on delay discounting and cannabis use.,"Episodic Future Thinking (EFT), mental simulation of personally relevant and positive future events, may modulate delay discounting (DD) in cannabis users. Whether EFT impacts cannabis use, whether DD mediates this effect, and whether EFT can be enhanced by prompting future events across specific life domains is unknown. Active, adult cannabis users (n = 90) recruited from Amazon mTurk and Qualtrics Panels were administered an Episodic Specificity Induction (ESI) to enhance quality of imagined events before being randomized to EFT, domain-specific-EFT (DS-EFT), or Episodic Recent Thinking (ERT). All participants created four, positive life events; DS-EFT participants imagined social, leisure, health, and financial events. Event-quality ratings were assessed (e.g., enjoyment). DD was assessed at baseline (Day 1), post-intervention (Days 2-4), and follow-up (Days 9-12). Cannabis use was assessed at baseline and follow-up. Differences in change in days and grams of cannabis use between conditions and mediation of changes in use by DD were examined. No differences in DD were observed between conditions. DS-EFT, but not EFT, showed significantly greater reductions in grams (d = .54) and days of cannabis use (d = .50) than ERT. DS-EFT and EFT demonstrated significantly greater event-quality ratings than ERT (ds > .55). EFT-based interventions showed potential for reducing cannabis use. Unexpectedly, effects on DD did not mediate this effect. Further testing with larger samples of cannabis users is needed to better understand EFT's mechanisms of action and determine optimal implementation strategies. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,DS-EFT and EFT demonstrated significantly greater event-quality ratings than ERT (ds > .55).,"['cannabis users', 'adult cannabis users (n = 90) recruited from']","['DS-EFT and EFT', 'Amazon mTurk and Qualtrics Panels were administered an Episodic Specificity Induction (ESI', 'EFT, domain-specific-EFT (DS-EFT), or Episodic Recent Thinking (ERT', 'EFT-based interventions', 'EFT']","['DD', 'positive life events; DS-EFT participants imagined social, leisure, health, and financial events', 'Event-quality ratings', 'event-quality ratings']","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0557155', 'cui_str': 'Life event observable'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",90.0,0.0429426,DS-EFT and EFT demonstrated significantly greater event-quality ratings than ERT (ds > .55).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sofis', 'Affiliation': 'Geisel School of Medicine, Dartmouth College, Center for Technology and Behavioral Health.'}, {'ForeName': 'Shea M', 'Initials': 'SM', 'LastName': 'Lemley', 'Affiliation': 'Geisel School of Medicine, Dartmouth College, Center for Technology and Behavioral Health.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Jacobson', 'Affiliation': 'Geisel School of Medicine, Dartmouth College, Center for Technology and Behavioral Health.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Budney', 'Affiliation': 'Geisel School of Medicine, Dartmouth College, Center for Technology and Behavioral Health.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000501']
1328,34022697,"Docetaxel, cisplatin and 5-FU compared with docetaxel, cisplatin and cetuximab as induction chemotherapy in advanced squamous cell carcinoma of the head and neck: Results of a randomised phase II AGMT trial.","PURPOSE


Induction chemotherapy (ICT) with cisplatin (P), 5-FU (F) and taxanes (T) is a therapeutical option in patients suffering from locally advanced or unresectable stage III or IV squamous cell carcinoma of the head and neck (SCCHN). The role of ICT is controversial, and toxicity and/or delay of radiotherapy (RT) may reduce the potential benefit of this treatment regimen. Here, we report the results of a randomised phase II trial comparing TPF with TP + cetuximab (C).
PATIENTS AND METHODS


In this trial, 100 patients with locally advanced stage III or IV SCCHN were included in the analysis. Patients were randomly assigned to either TPF-ICT (N = 49) or TPC-ICT (N = 51), both followed by RT + C. The primary end-point of the study was overall response rate (ORR) three months after RT + C was finished.
RESULTS


On an intention-to-treat basis, the ORR (complete remission + partial remission) was 74.5% in the TPC arm compared with 63.3% in the TPF arm (p = 0.109). OS was similar in both arms 400 days after treatment was initiated (86.1% [95% confidence interval {CI}, 73.0-93.1%] in the TPC arm and 78.5% [95% CI, 63.7-87.8%] in the TPF arm). TPC resulted in slightly less serious adverse events and in less haematological, but more skin toxicities. Two patients randomised in the TPC arm died during ICT and RT. Four patients in the TPF arm died after completion of RT. No delay from the end of ICT to RT + C was observed. A total of 83.1% of patients (80% in the TPC arm; 86% in the TPF arm) received RT without dose reduction and/or modification.
CONCLUSION


TPC-containing ICT for patients with locally advanced SCCHN was found to be an effective and tolerable one-day regimen. Further prospective evidence from larger trials is warranted.",2021,"OS was similar in both arms 400 days after treatment was initiated (86.1% [95% confidence interval {CI}, 73.0-93.1%] in the TPC arm and 78.5% [95% CI, 63.7-87.8%] in the TPF arm).","['advanced squamous cell carcinoma of the head and neck', '100 patients with locally advanced stage III or IV SCCHN were included in the analysis', 'patients suffering from locally advanced or unresectable stage III or IV squamous cell carcinoma of the head and neck (SCCHN']","['docetaxel, cisplatin and cetuximab', 'ICT', 'TPF with TP\xa0+\xa0cetuximab (C', 'Induction chemotherapy (ICT) with cisplatin (P), 5-FU (F) and taxanes (T', 'TPC-containing ICT', 'TPC-ICT (N\xa0=\xa051), both followed by RT\xa0+\xa0C', 'TPC', 'RT', 'TPF-ICT', 'Docetaxel, cisplatin and 5-FU', 'radiotherapy (RT']","['skin toxicities', 'ORR (complete remission\xa0+\xa0partial remission', 'overall response rate (ORR', 'OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",100.0,0.041474,"OS was similar in both arms 400 days after treatment was initiated (86.1% [95% confidence interval {CI}, 73.0-93.1%] in the TPC arm and 78.5% [95% CI, 63.7-87.8%] in the TPF arm).","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Keil', 'Affiliation': 'Medical Dept. Int. Med. 3, Hematology and Oncology, Hanusch-Krankenhaus, Heinrich-Collin-Straße 30, Wien, A-1140, Austria. Electronic address: felix.keil@oegk.at.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Hartl', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Hospital of Bamherzigen Schwestern, Linz, Seilerstätte 4, Linz, A-4010, Austria.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Altorjai', 'Affiliation': 'Medical University Vienna, University Clinic of Radiation Therapy and Radiation Biology, General Hospital of Vienna, Währinger Gürtel 18-20, Wien, A-1090, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Berghold', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University Graz, Auenbruggerplatz 2, Graz, A-8036, Austria.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Riedl', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University Graz, Auenbruggerplatz 2, Graz, A-8036, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pecherstorfer', 'Affiliation': 'University Clinic of Internal Medicine II, Department of Hematology and Oncology, Mitterweg 10, Krems, A-3500, Austria.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Mayrbäurl', 'Affiliation': 'Department of Internal Medicine IV, Hematology, Internal Oncology and Palliative Medicine, Nephrology and Dialysis, Hospital of Wels-Grieskirchen, Grieskirchner Straße 42, Wels, A-4600, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'De Vries', 'Affiliation': 'Radiation Therapy LKH Feldkirch, Carinagasse 47, Feldkirch, A-6807, Austria.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Schuster', 'Affiliation': 'Arbeitsgemeinschaft Medikamento¨se Tumortherapie gemeinnu¨tzige GmbH, Wolfsgartenweg 31, A-5020 Salzburg, Austria.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Hackl', 'Affiliation': 'Kepler University Clinic of Internal Medicine II, Department of Hematology and Oncology, Krankenhausstraße 7a, Linz, A-4020, Austria.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Füreder', 'Affiliation': 'Medical University of Vienna, Department of Internal Medicine I & Comprehensive Cancer Center Division of Oncology, General Hospital of Vienna, Währinger Gürtel 18-20, Wien, A-1090, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Melchardt', 'Affiliation': '3rd Medical Department with Hematology and Medical Oncology, Paracelsus Medical University Salzburg and Salzburg Cancer Research Institute-CCCIT, Salzburg, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Burian', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Hospital of Bamherzigen Schwestern, Linz, Seilerstätte 4, Linz, A-4010, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Paracelsus Medical University, Internal Medicine III, Hematology & Medical Oncology, Mu¨llner Hauptstraße 48, A-5020 Salzburg, Austria; Salzburg Cancer Research Institute-CCCIT and Cancer Cluster Salzburg, Austria.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.03.051']
1329,34049443,Facilitators of and barriers to implementing a traditional Chinese medicine collaborative model of care for axial spondyloarthritis: a qualitative study.,"BACKGROUND


Conventional therapy may be inadequate for many patients with axial spondyloarthritis (axSpA). Traditional Chinese medicine (TCM) may be a viable alternative, but its effectiveness for axSpA is unknown. We are currently conducting a pragmatic randomised controlled trial (RCT) to investigate the effectiveness of a TCM collaborative model of care (TCMCMC), which combines usual rheumatologic care with acupuncture for patients with axSpA. This nested qualitative sub-study aims to identify facilitators of and barriers to the implementation of the TCMCMC.
METHODS


We conducted individual in-depth interviews with participants who had completed the acupuncture regimen to elicit opinions on the facilitators of and barriers to the implementation of the TCMCMC. The interviews were transcribed and analysed using thematic analysis.
RESULTS


Twelve participants were included, with data saturation occurring after 10 interviews. The analysis revealed both a number of important 'facilitators' and 'barriers'. Facilitators to the implementation of the TCMCMC included effectiveness of TCM to relieve symptoms, inadequacy of conventional treatment and positive social perceptions of TCM. Barriers included scepticism towards TCM, inability of TCM to provide instant relief, needle-related discomfort, variable effectiveness of TCM influenced by physicians' skills and experience and the high cost of TCM. Recommendations to overcome barriers included further patient education about TCM.
CONCLUSION


Policymakers should take into account the various feasibility factors identified in this study when developing and implementing a TCMCMC.
TRIAL REGISTRATION NUMBER


NCT03420404 (ClinicalTrials.gov).",2021,"We are currently conducting a pragmatic randomised controlled trial (RCT) to investigate the effectiveness of a TCM collaborative model of care (TCMCMC), which combines usual rheumatologic care with acupuncture for patients with axSpA. This nested qualitative sub-study aims to identify facilitators of and barriers to the implementation of the TCMCMC.
","['participants who had completed the acupuncture regimen to elicit opinions on the facilitators of and barriers to the implementation of the TCMCMC', 'Twelve participants were included, with data saturation occurring after 10 interviews', 'patients with axial spondyloarthritis (axSpA']","['acupuncture', 'TCM collaborative model of care (TCMCMC', 'TCM', 'Traditional Chinese medicine (TCM']",[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",[],12.0,0.0848795,"We are currently conducting a pragmatic randomised controlled trial (RCT) to investigate the effectiveness of a TCM collaborative model of care (TCMCMC), which combines usual rheumatologic care with acupuncture for patients with axSpA. This nested qualitative sub-study aims to identify facilitators of and barriers to the implementation of the TCMCMC.
","[{'ForeName': 'Yu Heng', 'Initials': 'YH', 'LastName': 'Kwan', 'Affiliation': 'Program in Health Systems and Services Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Fong', 'Affiliation': 'Department of Rheumatology and Immunology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Xiang Ling', 'Initials': 'XL', 'LastName': 'Ang', 'Affiliation': 'Singapore Thong Chai Medical Institution, Singapore.'}, {'ForeName': 'Xiu Yan', 'Initials': 'XY', 'LastName': 'Chew', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore.'}, {'ForeName': 'Sungwon', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Program in Health Systems and Services Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Chuen Seng', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Youyi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Internal Medicine Residency, SingHealth, Singapore.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bilger', 'Affiliation': 'Health Economics and Policy Group, Vienna University of Economics and Business, Vienna, Austria.'}, {'ForeName': 'Jie Kie', 'Initials': 'JK', 'LastName': 'Phang', 'Affiliation': 'Department of Rheumatology and Immunology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Hui Chin', 'Initials': 'HC', 'LastName': 'Tan', 'Affiliation': 'Singapore Thong Chai Medical Institution, Singapore.'}, {'ForeName': 'Su-An', 'Initials': 'SA', 'LastName': 'Quek', 'Affiliation': 'Singapore Thong Chai Medical Institution, Singapore.'}, {'ForeName': 'Sing Yee Clara', 'Initials': 'SYC', 'LastName': 'Eng', 'Affiliation': 'Singapore Thong Chai Medical Institution, Singapore.'}, {'ForeName': 'Choy Tip', 'Initials': 'CT', 'LastName': 'Tan', 'Affiliation': 'Singapore Thong Chai Medical Institution, Singapore.'}, {'ForeName': 'Bao Qiang', 'Initials': 'BQ', 'LastName': 'Dong', 'Affiliation': ""Liaoning University of Traditional Chinese Medicine, Shenyang, People's Republic of China.""}, {'ForeName': 'Hwee Ling', 'Initials': 'HL', 'LastName': 'Koh', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore.'}, {'ForeName': 'Ying Ying', 'Initials': 'YY', 'LastName': 'Leung', 'Affiliation': 'Department of Rheumatology and Immunology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Swee Cheng', 'Initials': 'SC', 'LastName': 'Ng', 'Affiliation': 'Department of Rheumatology and Immunology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Kok Yong', 'Initials': 'KY', 'LastName': 'Fong', 'Affiliation': 'Department of Rheumatology and Immunology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Thumboo', 'Affiliation': 'Program in Health Systems and Services Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Østbye', 'Affiliation': 'Program in Health Systems and Services Research, Duke-NUS Medical School, Singapore.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/09645284211009543']
1330,34052092,"Normal saline and lung recruitment with paediatric endotracheal suction (NARES): A pilot, factorial, randomised controlled trial.","BACKGROUND/OBJECTIVE


Endotracheal suction is one of the most common and harmful procuedres performed on mechanically ventilated children. The aim of the study was to establish the feasibility of a randomised controlled trial (RCT) examining the effectiveness of normal saline instillation (NSI) and a positive end-expiratory pressure recruitment manoeuvre (RM) with endotracheal suction in the paediatric intensive care unit.
METHODS


Pilot 2 × 2 factorial RCT. The study was conducted at a 36-bed tertiary paediatric intensive care unit in Australia. Fifty-eight children aged less than 16 years undergoing tracheal intubation and invasive mechanical ventilation. (i) NSI or no NSI and (ii) RM or no RM with endotracheal suction . The primary outcome was feasibility; secondary outcomes were ventilator-associated pneumonia (VAP), change in end-expiratory lung volume assessed by electrical impedance tomography, dynamic compliance, and oxygen saturation-to-fraction of inspired oxygen (SpO 2 /FiO 2 ) ratio.
RESULTS/FINDINGS


Recruitment, retention, and missing data feasibility criteria were achieved. Eligibility and protocol adherence criteria were not achieved, with 818 patients eligible and 58 enrolled; cardiac surgery was the primary reason for exclusion. Approximately 30% of patients had at least one episode of nonadherence. Children who received NSI had a reduced incidence of VAP; however, this did not reach statistical significance (incidence rate ratio = 0.12, 95% confidence interval = 0.01-1.10; p = 0.06). NSI was associated with a significantly reduced SpO 2 /FiO 2  ratio up to 10 min after suction. RMs were not associated with a reduced VAP incidence (incidence rate ratio = 0.31, 95% confidence interval = 0.05-1.88), but did significantly improve end-expiratory lung volume at 2 and 5 min after suction, dynamic compliance, and SpO 2 /FiO 2  ratio.
CONCLUSION


RMs provided short-term improvements in end-expiratory lung volume and oxygenation. NSI with suction led to a reduced incidence of VAP; however, a definitive RCT is needed to test statistical differences. A RCT of study interventions is worthwhile and may be feasible with protocol modifications including the widening of participant eligibility.",2021,"Children who received NSI had a reduced incidence of VAP; however, this did not reach statistical significance (incidence rate ratio = 0.12, 95% confidence interval = 0.01-1.10; p = 0.06).","['36-bed tertiary paediatric intensive care unit in Australia', 'Pilot 2', 'Fifty-eight children aged less than 16 years undergoing tracheal intubation and invasive mechanical ventilation', '818 patients eligible and 58 enrolled; cardiac surgery was the primary reason for exclusion', 'mechanically ventilated children']","['NSI or no NSI and (ii) RM or no RM with endotracheal suction ', 'normal saline instillation (NSI) and a positive end-expiratory pressure recruitment manoeuvre (RM) with endotracheal suction', 'Normal saline and lung recruitment with paediatric endotracheal suction (NARES', 'NSI']","['feasibility; secondary outcomes were ventilator-associated pneumonia (VAP), change in end-expiratory lung volume assessed by electrical impedance tomography, dynamic compliance, and oxygen saturation-to-fraction of inspired oxygen (SpO 2 /FiO 2 ) ratio', 'incidence of VAP', 'VAP', 'reduced VAP incidence', 'end-expiratory lung volume']","[{'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",58.0,0.459981,"Children who received NSI had a reduced incidence of VAP; however, this did not reach statistical significance (incidence rate ratio = 0.12, 95% confidence interval = 0.01-1.10; p = 0.06).","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Schults', 'Affiliation': ""Paediatric Intensive Care Unit, Queensland Children's Hospital, South Brisbane, Queensland, Australia; Menzies Health Institute Queensland, School of Nursing and Midwifery, Griffith University, Queensland, Australia; Paediatric Critical Care Research Group, Centre for Children's Health Research, The University of Queensland, South Brisbane, Queensland, Australia. Electronic address: j.schults@griffith.edu.au.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Cooke', 'Affiliation': 'Menzies Health Institute Queensland, School of Nursing and Midwifery, Griffith University, Queensland, Australia.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': ""Paediatric Intensive Care Unit, Queensland Children's Hospital, South Brisbane, Queensland, Australia; Menzies Health Institute Queensland, School of Nursing and Midwifery, Griffith University, Queensland, Australia; Paediatric Critical Care Research Group, Centre for Children's Health Research, The University of Queensland, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schibler', 'Affiliation': ""Paediatric Intensive Care Unit, Queensland Children's Hospital, South Brisbane, Queensland, Australia; Paediatric Critical Care Research Group, Centre for Children's Health Research, The University of Queensland, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Charles', 'Affiliation': 'Menzies Health Institute Queensland, School of Nursing and Midwifery, Griffith University, Queensland, Australia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Irwin', 'Affiliation': ""UQ Centre for Clinical Research, The University of Queensland, Australia; Infection Management and Prevention Service, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Marion L', 'Initials': 'ML', 'LastName': 'Mitchell', 'Affiliation': 'Menzies Health Institute Queensland, School of Nursing and Midwifery, Griffith University, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Queensland, Australia.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2021.01.006']
1331,34040056,Effectiveness of simulation-based training for manual small incision cataract surgery among novice surgeons: a randomized controlled trial.,"This study was designed to determine the effect of a novel simulation-based training curriculum for scleral tunnel construction in manual small incision cataract surgery (MSICS) compared with traditional training. In this multicenter, investigator-masked, randomized clinical trial, resident surgeons within 3 months of matriculation with minimal or no prior experience with MSICS were assigned either to simulation-based training, the Experimental Group (EG), or to conventional training, the Control Group (CG). EG residents were trained to perform scleral tunnel construction using a simulation-based curriculum (HelpMeSee Eye Surgery Simulator), while residents in the CG followed institution-specific curriculum before progressing to live surgery. Surgical videos of the first 20 attempts at tunnel construction were reviewed by masked video raters. The primary outcome was the total number of any of 9 pre-specified errors. On average, the total number of errors was 9.25 (95% CI 0-18.95) in the EG and 17.56 (95% CI 6.63-28.49) in the CG (P = 0.05); the number of major errors was 4.86 (95% CI 0.13-9.59) in the EG and 10.09 (95% CI 4.76-15.41) in the CG (P = 0.02); and the number of minor errors was 4.39 (95% CI 0-9.75) in the EG and 7.47 (95% CI 1.43-13.51) in the CG (P = 0.16). These results support that novice surgeons trained using the novel simulation-based curriculum performed fewer errors in their first 20 attempts at tunnel construction compared to those trained with a conventional curriculum.",2021,These results support that novice surgeons trained using the novel simulation-based curriculum performed fewer errors in their first 20 attempts at tunnel construction compared to those trained with a conventional curriculum.,"['manual small incision cataract surgery among novice surgeons', 'resident surgeons within 3\xa0months of matriculation with minimal or no prior experience with MSICS']","['scleral tunnel construction using a simulation-based curriculum (HelpMeSee Eye Surgery Simulator), while residents in the CG followed institution-specific curriculum before progressing to live surgery', 'novel simulation-based training curriculum', 'simulation-based training', 'manual small incision cataract surgery (MSICS', 'simulation-based training, the Experimental Group (EG), or to conventional training, the Control Group (CG', 'traditional training']","['number of minor errors', 'number of major errors', 'total number of errors', 'total number of any of 9 pre-specified errors']","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0442612', 'cui_str': 'Tunnel construction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0038901', 'cui_str': 'Ophthalmologic Surgical Procedure'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.305824,These results support that novice surgeons trained using the novel simulation-based curriculum performed fewer errors in their first 20 attempts at tunnel construction compared to those trained with a conventional curriculum.,"[{'ForeName': 'Akshay Gopinathan', 'Initials': 'AG', 'LastName': 'Nair', 'Affiliation': 'HelpMeSee Inc., 703 A, Supreme Business Park, Powai, Hiranandani, Mumbai, 400 076, India. akshay@helpmesee.org.'}, {'ForeName': 'Chetan', 'Initials': 'C', 'LastName': 'Ahiwalay', 'Affiliation': 'HelpMeSee Inc., 703 A, Supreme Business Park, Powai, Hiranandani, Mumbai, 400 076, India.'}, {'ForeName': 'Ashish E', 'Initials': 'AE', 'LastName': 'Bacchav', 'Affiliation': 'HelpMeSee Inc., 703 A, Supreme Business Park, Powai, Hiranandani, Mumbai, 400 076, India.'}, {'ForeName': 'Tejas', 'Initials': 'T', 'LastName': 'Sheth', 'Affiliation': 'HelpMeSee Inc., 703 A, Supreme Business Park, Powai, Hiranandani, Mumbai, 400 076, India.'}, {'ForeName': 'Van Charles', 'Initials': 'VC', 'LastName': 'Lansingh', 'Affiliation': 'HelpMeSee Inc., New York, USA.'}, {'ForeName': 'S Swaroop', 'Initials': 'SS', 'LastName': 'Vedula', 'Affiliation': 'HelpMeSee Inc., 703 A, Supreme Business Park, Powai, Hiranandani, Mumbai, 400 076, India.'}, {'ForeName': 'Venudhar', 'Initials': 'V', 'LastName': 'Bhatt', 'Affiliation': 'HelpMeSee Inc., 703 A, Supreme Business Park, Powai, Hiranandani, Mumbai, 400 076, India.'}, {'ForeName': 'Jagadesh C', 'Initials': 'JC', 'LastName': 'Reddy', 'Affiliation': 'L V Prasad Eye Institute, Banjara Hills, Hyderabad, India.'}, {'ForeName': 'Pravin K', 'Initials': 'PK', 'LastName': 'Vadavalli', 'Affiliation': 'L V Prasad Eye Institute, Banjara Hills, Hyderabad, India.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Praveen', 'Affiliation': 'Sankara Nethralaya, Nungambakkam, Chennai, India.'}, {'ForeName': 'Nikhilesh Anil', 'Initials': 'NA', 'LastName': 'Wairagade', 'Affiliation': 'Mahatme Eye Bank and Eye Hospital, Somalwada, Nagpur, India.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Pettey', 'Affiliation': 'John A. Moran Eye Center, Salt Lake City, UT, USA.'}]",Scientific reports,['10.1038/s41598-021-90410-4']
1332,34053852,Smartphone-based lifestyle coaching modifies behaviours in women with subfertility or recurrent miscarriage: a randomized controlled trial.,"RESEARCH QUESTION


Is an online lifestyle coaching platform more effective at modifying periconceptional behaviours than standard advice offered by the UK National Health Service (NHS)?
DESIGN


Women with subfertility or recurrent miscarriage were recruited to a two-centre randomized controlled trial. They were randomized to either the online lifestyle coaching platform Smarter Pregnancy (intervention) or periconceptional advice provided by NHS websites (control). Participants completed a lifestyle questionnaire at baseline, 6, 12, 18 and 24 weeks, and the results were used to tailor lifestyle coaching in the intervention group. At baseline, 12 and 24 weeks, composite risk scores (CRS) were calculated. A lower CRS corresponds to a healthier lifestyle.
RESULTS


Of the 400 women recruited, 262 women were randomized (131 in each arm). At 12 weeks, a reduction in CRS (includes risk score for intake of folic acid, vegetables and fruits, smoking and alcohol) was observed in the intervention versus control arms. After correcting for baseline, the difference in the CRS between intervention and control was -0.47 (95% CI -0.97 to 0.02) at 12 weeks and -0.32 (95% CI -0.82 to 0.15) at 24 weeks. A statistically significant reduction in lifestyle risk scores was found in women with a body mass index (BMI) of 25 kg/m 2  or above compared with those with a BMI below 25kg/m 2 . The odds of being pregnant at 24 weeks was increased in the intervention versus control (OR 2.83, 95% CI 0.35 to 57.76).
CONCLUSIONS


The Smarter Pregnancy coaching platform is more effective in delivering lifestyle advice and modulating behaviours to support women with a history of subfertility or recurrent miscarriage than standard online NHS advice.",2021,"The odds of being pregnant at 24 weeks was increased in the intervention versus control (OR 2.83, 95% CI 0.35 to 57.76).
","['women with subfertility or recurrent miscarriage', 'Women with subfertility or recurrent miscarriage', '400 women recruited, 262 women were randomized (131 in each arm']","['Smartphone-based lifestyle coaching modifies behaviours', 'online lifestyle coaching platform Smarter Pregnancy (intervention) or periconceptional advice provided by NHS websites (control']","['lifestyle risk scores', 'composite risk scores (CRS', 'reduction in CRS (includes risk score for intake of folic acid, vegetables and fruits, smoking and alcohol']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341869', 'cui_str': 'Sub-Fertility, Female'}, {'cui': 'C0000809', 'cui_str': 'Recurrent miscarriage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]",400.0,0.135452,"The odds of being pregnant at 24 weeks was increased in the intervention versus control (OR 2.83, 95% CI 0.35 to 57.76).
","[{'ForeName': 'Ka Ying Bonnie', 'Initials': 'KYB', 'LastName': 'Ng', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton SO16 6YD, UK; Department of Obstetrics and Gynaecology, Princess Anne Hospital, Room F86, Level F, Coxford Road, Southampton SO16 5YA, UK. Electronic address: bonnie.ng@doctors.org.uk.'}, {'ForeName': 'Régine', 'Initials': 'R', 'LastName': 'Steegers-Theunissen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Willemsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands; Department of Epidemiology, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wellstead', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton SO16 6YD, UK; Department of Obstetrics and Gynaecology, Princess Anne Hospital, Room F86, Level F, Coxford Road, Southampton SO16 5YA, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton SO16 6YD, UK; Department of Obstetrics and Gynaecology, Princess Anne Hospital, Room F86, Level F, Coxford Road, Southampton SO16 5YA, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Macklon', 'Affiliation': ""Reprohealth, Zealand University Hospital, University of Copenhagen, Denmark; London Women's Clinic, London, UK.""}]",Reproductive biomedicine online,['10.1016/j.rbmo.2021.04.003']
1333,34053824,Online interventions to reduce stigma towards population groups affected by blood borne viruses in Australia.,"BACKGROUND


Stigmatising attitudes and behaviours by others can have a range of negative effects for population groups and individual people affected by blood borne viruses. The reduction of stigma is a major goal within current Australian national health strategies, however, there is a lack of evidence regarding effective interventions to achieve this goal. Drawing on Allport's (1954) intergroup contact theory, this study aimed to evaluate the effectiveness of an online stigma reduction intervention implemented with the Australian public.
METHODS


The study was conducted between February and May 2020. Australian adults recruited via Facebook advertising were randomly allocated to a control group (n=316) or one of five intervention groups: people living with HIV (n=320), people living with hepatitis C (n=347), people living with hepatitis B (n=333), people who inject drugs (n=316), or sex workers (n=296). Participants viewed a short video depicting lived experiences of their assigned group. Participants completed attitudinal measures about the group before and immediately after the video, and then at three-month follow-up. These measures related to overall attitudes towards the group, controllability of the stigmatised condition/behaviour, desire to maintain personal distance from the group, and opinions regarding treatment of the group in health care and public policy. Longitudinal changes in attitudes were analysed using a mixed effects regression model with maximum likelihood estimation.
RESULTS


Across each of the intervention groups, reductions in negative attitudes were found immediately after watching the videos on almost all outcome measures. By three-month follow-up, the HIV intervention group demonstrated long-term improvements in relation to personal distance compared to the control group, and the hepatitis B intervention group demonstrated long-term improvements in relation to attitudes and personal distance compared to the control group. Across intervention and control groups, long-term reductions in negative attitudes were found in relation to HIV controllability, hepatitis B controllability and opinions, hepatitis C controllability and opinions, and injecting drug use attitudes and opinions.
CONCLUSION


Brief online videos depicting priority populations groups demonstrated positive results in terms of reducing some stigmatising attitudes towards those groups amongst members of the Australian public. Online contact interventions have the potential to be scaled up and rolled out across jurisdictions at national and international levels. These findings suggest that these interventions could be an effective way to contribute to the reduction of stigma and discrimination towards populations affected by blood borne viruses.",2021,"Across each of the intervention groups, reductions in negative attitudes were found immediately after watching the videos on almost all outcome measures.","['Australian adults recruited via Facebook advertising were randomly allocated to a control group (n=316) or one of five intervention groups: people living with HIV (n=320), people living with hepatitis C (n=347), people living with hepatitis B (n=333), people who inject drugs (n=316), or sex workers (n=296']",['online stigma reduction intervention'],"['negative attitudes', 'relation to personal distance', 'HIV controllability, hepatitis B controllability and opinions, hepatitis C controllability and opinions, and injecting drug use attitudes and opinions', 'relation to attitudes and personal distance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0240816', 'cui_str': 'Sex worker'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262620', 'cui_str': 'Negative attitude'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.00798119,"Across each of the intervention groups, reductions in negative attitudes were found immediately after watching the videos on almost all outcome measures.","[{'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Broady', 'Affiliation': 'Centre for Social Research in Health, UNSW Sydney, Australia. Electronic address: t.broady@unsw.edu.au.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Brener', 'Affiliation': 'Centre for Social Research in Health, UNSW Sydney, Australia.'}, {'ForeName': 'Thu', 'Initials': 'T', 'LastName': 'Vuong', 'Affiliation': 'Social Policy Research Centre, UNSW Sydney, Australia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cama', 'Affiliation': 'Centre for Social Research in Health, UNSW Sydney, Australia.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Treloar', 'Affiliation': 'Centre for Social Research in Health, UNSW Sydney, Australia.'}]",The International journal on drug policy,['10.1016/j.drugpo.2021.103292']
1334,34058256,The Influence of Patient-Provider Language Concordance in Cancer Care: Results of the Hispanic Outcomes by Language Approach (HOLA) Randomized Trial.,"PURPOSE


Delivering linguistically competent care is critical to serving patients who have limited English proficiency (LEP) and represents a key national strategy to help reduce health disparities. Current acceptable standards of communication with patients who have LEP include providers communicating through professional interpretive services or bilingual providers speaking the patients' preferred language directly. This randomized clinical trial tests the effect of patient-provider language concordance on patient satisfaction.
METHODS AND MATERIALS


Eighty-three adult Spanish-speaking patients with cancer were randomly assigned to receive care from either (1) 1 of 2 bilingual physicians speaking to the patient directly in Spanish or (2) the same physicians speaking English and using a professional interpreter service. Validated questionnaires were administered to assess patient-reported satisfaction with both provider communication and overall care. Transcripts of initial consultations were analyzed for content variations.
RESULTS


Compared with patients receiving care through professional interpretive services, patients cared for in direct Spanish reported significantly improved general satisfaction, technical quality of care (mean composite score [MCS], 4.41 vs 4.06; P = .005), care team interpersonal manner (MCS, 4.37 vs 3.88; P = .004), communication (MCS, 4.50 vs 4.25; P = .018), and time spent with patient,(MCS, 4.30 vs 3.92; P = .028). Specific to physician communication, patients rated direct-Spanish care more highly in perceived opportunity to disclose concerns (MCS 4.91 vs 4.62; P = .001), physician empathy (MCS, 4.94 vs 4.59; P <.001), confidence in physician abilities (MCS, 4.84 vs 4.51; P = .001), and general satisfaction with their physician (MCS, 4.88 vs 4.59; P <.001). Analyzing the content of consultation encounters revealed differences between study arms, with the direct-Spanish arm having more physician speech related to patient history verification (mean number of utterances, 13 vs 9; P = .01) and partnering activities (mean utterances, 16 vs 5; P <.001). Additionally, patients in the direct-Spanish arm were more likely to initiate unprompted speech (mean utterances, 11 vs 3; P <.001) and asked their providers more questions (mean utterances, 11 vs 4; P = .007).
CONCLUSIONS


This study shows improved patient-reported satisfaction among patients with cancer who had LEP and were cared for in direct Spanish compared with interpreter-based communication. Further research into interventions to mitigate the patient-provider language barrier is necessary to optimize care for this population.",2021,"Specific to physician communication, patients rated direct Spanish care more highly in perceived opportunity to disclose concerns (MCS 4.91 vs 4.62, p=0.001), physician empathy (MCS 4.94 vs 4.59, p<0.001), confidence in physician abilities (MCS 4.84 vs 4.51, p=0.001), and general satisfaction with their physician (MCS 4.88 vs 4.59, p<0.001).","['patient-provider language concordance in cancer care', 'Eighty-three adult Spanish-speaking cancer patients', 'patient-provider language concordance on patient satisfaction']",['bilingual physician speaking to the patient directly in Spanish or 2) the same physicians speaking English and using a professional interpreter service'],"['care team interpersonal manner', 'partnering activities', 'general satisfaction', 'general satisfaction, technical quality of care', 'physician empathy', 'initiate unprompted speech', 'confidence in physician abilities', 'time spent']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0150646', 'cui_str': 'Interpreter'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",83.0,0.149638,"Specific to physician communication, patients rated direct Spanish care more highly in perceived opportunity to disclose concerns (MCS 4.91 vs 4.62, p=0.001), physician empathy (MCS 4.94 vs 4.59, p<0.001), confidence in physician abilities (MCS 4.84 vs 4.51, p=0.001), and general satisfaction with their physician (MCS 4.88 vs 4.59, p<0.001).","[{'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Seible', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California, San Diego, California.'}, {'ForeName': 'Souma', 'Initials': 'S', 'LastName': 'Kundu', 'Affiliation': 'School of Medicine, University of California, San Diego, California.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Azuara', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California, San Diego, California.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Cherry', 'Affiliation': 'School of Medicine, University of California, San Diego, California.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Arias', 'Affiliation': 'School of Medicine, University of California, San Diego, California.'}, {'ForeName': 'Vinit V', 'Initials': 'VV', 'LastName': 'Nalawade', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California, San Diego, California.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cruz', 'Affiliation': 'School of Medicine, University of California, San Diego, California.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Arreola', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California, San Diego, California.'}, {'ForeName': 'Maria Elena', 'Initials': 'ME', 'LastName': 'Martinez', 'Affiliation': 'Department of Family and Preventive Medicine, University of California, San Diego, California.'}, {'ForeName': 'Jesse N', 'Initials': 'JN', 'LastName': 'Nodora', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, California.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Rahn', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California, San Diego, California.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Murphy', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California, San Diego, California. Electronic address: j2murphy@ucsd.edu.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.05.122']
1335,34074227,Effects of Nordic hamstring exercise combined with glider exercise on hip flexion flexibility and hamstring passive stiffness.,"Eccentric training proved to be effective in hamstring injury prevention; however, little is known about effects of eccentric hamstring training at long muscle length on hamstring flexibility. Hence, the aim was to evaluate the effect of eccentric training at long muscle lengths on flexibility and passive properties of the hamstring muscles. 34 physically active young adults were randomized to either the control or intervention group (6 weeks of eccentric hamstring training at long muscle length; control group resumed with their usual activities). Maximal passive hip flexion range of motion (ROM), passive hamstring stiffness, shear modulus and tendon length of the biceps femoris long head (BFlh) were measured pre- and post-intervention. A significant time × group effect was observed for maximal passive hip ROM. Post-hoc testing revealed a significant increase in the intervention group (+11.2%; p < 0.001; d = 1.55). Additionally, a significant time effect was shown for shear modulus in a relaxed position (p < 0.001). No significant interaction was shown for other parameters. Results indicate that eccentric hamstring training at long muscle length elicits large gains in hamstring flexibility, which are most likely not related to changes in passive hamstring stiffness or BFlh distal tendon length.",2021,"Additionally, a significant time effect was shown for shear modulus in a relaxed position (p < 0.001).",['34 physically active young adults'],"['Eccentric training', 'eccentric training', 'control or intervention group (6\xa0weeks of eccentric hamstring training at long muscle length; control group resumed with their usual activities', 'Nordic hamstring exercise combined with glider exercise', 'eccentric hamstring training']","['maximal passive hip ROM', 'Maximal passive hip flexion range of motion (ROM), passive hamstring stiffness, shear modulus and tendon length of the biceps femoris long head (BFlh', 'hip flexion flexibility and hamstring passive stiffness']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0336863', 'cui_str': 'Glider'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",34.0,0.0112658,"Additionally, a significant time effect was shown for shear modulus in a relaxed position (p < 0.001).","[{'ForeName': 'Rok', 'Initials': 'R', 'LastName': 'Vatovec', 'Affiliation': 'University of Primorska, Faculty of Health Sciences, Izola, Slovenia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Marušič', 'Affiliation': 'University of Primorska, Faculty of Health Sciences, Izola, Slovenia.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Marković', 'Affiliation': 'University of Zagreb, Faculty of Kinesiology, Zagreb, Croatia.'}, {'ForeName': 'Nejc', 'Initials': 'N', 'LastName': 'Šarabon', 'Affiliation': 'University of Primorska, Faculty of Health Sciences, Izola, Slovenia.'}]",Journal of sports sciences,['10.1080/02640414.2021.1933350']
1336,34081045,Comparison of the Spectral Features of the Frontal Electroencephalogram in Patients Receiving Xenon and Sevoflurane General Anesthesia.,"BACKGROUND


Depth-of-anesthesia monitoring is often utilized for patients receiving xenon anesthesia. Processed electroencephalogram (EEG) depth-of-anesthesia monitoring relies to a significant extent on frequency domain analysis of the frontal EEG, and there is evidence that the spectral features observed under anesthesia vary significantly between anesthetic agents. The spectral features of the EEG during xenon anesthesia for a surgical procedure have not previously been described.
METHODS


Twenty-four participants scheduled for general anesthesia for lithotripsy were randomized to receive either xenon anesthesia or sevoflurane anesthesia. Frontal EEG recordings were obtained from each participant via the Brain Anesthesia Response Monitor (BARM). Twenty-two EEG recordings were suitable for analysis: 11 in participants who received sevoflurane and 11 in participants who received xenon. Spectrograms for the duration of the anesthetic episode were produced for each participant. Group-level spectral analysis was calculated for two 30-second EEG epochs: one recorded at awake baseline and the other during maintenance anesthesia. A linear mixed-effects model was utilized to compare the changes in 5 frequency bands from baseline to maintenance between the 2 groups.
RESULTS


The spectrograms of sevoflurane participants illustrate an increase in frontal delta (0.5-4 Hz), theta (4-8 Hz), and alpha (8-13 Hz) band power during maintenance anesthesia. In contrast, spectrograms of the xenon participants did not illustrate an increase in alpha power. The results of the linear mixed-effects model indicate that both agents were associated with a significant increase in delta power from baseline to maintenance. There was no significant difference in the magnitude of this increase observed between the agents. In contrast, sevoflurane anesthesia was associated with significantly greater absolute power in the theta, alpha, and beta (13-30 Hz) bands when compared to xenon. In terms of relative power, xenon was associated with a significant increase in delta power compared to sevoflurane, while sevoflurane was associated with greater increases in relative theta, alpha, and beta power.
CONCLUSIONS


Both xenon anesthesia and sevoflurane anesthesia were associated with significant increases in delta power. Sevoflurane anesthesia was also associated with increases in theta, alpha, and beta power, while xenon anesthesia was associated with greater consolidation of power in the delta band. Xenon anesthesia and sevoflurane anesthesia are associated with distinct spectral features. These findings suggest that appropriate depth-of-anesthesia monitoring may require the development of agent-specific spectral measures of unconsciousness.",2021,"In terms of relative power, xenon was associated with a significant increase in delta power compared to sevoflurane, while sevoflurane was associated with greater increases in relative theta, alpha, and beta power.
","['Patients Receiving Xenon and Sevoflurane General Anesthesia', 'Twenty-four participants scheduled for general anesthesia for lithotripsy', 'patients receiving xenon anesthesia']","['xenon', 'Xenon anesthesia and sevoflurane anesthesia', 'xenon anesthesia or sevoflurane anesthesia', 'sevoflurane', 'Sevoflurane anesthesia', 'sevoflurane anesthesia']","['alpha power', 'delta power', 'relative theta, alpha, and beta power', 'frontal delta', 'theta, alpha, and beta power, while xenon anesthesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",24.0,0.0282645,"In terms of relative power, xenon was associated with a significant increase in delta power compared to sevoflurane, while sevoflurane was associated with greater increases in relative theta, alpha, and beta power.
","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McGuigan', 'Affiliation': ""From the Department of Anesthesia and Acute Pain Medicine, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Evered', 'Affiliation': ""From the Department of Anesthesia and Acute Pain Medicine, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Silbert', 'Affiliation': ""From the Department of Anesthesia and Acute Pain Medicine, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Scott', 'Affiliation': ""From the Department of Anesthesia and Acute Pain Medicine, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Cormack', 'Affiliation': ""From the Department of Anesthesia and Acute Pain Medicine, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Abarna', 'Initials': 'A', 'LastName': 'Devapalasundaram', 'Affiliation': ""From the Department of Anesthesia and Acute Pain Medicine, St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'David T J', 'Initials': 'DTJ', 'LastName': 'Liley', 'Affiliation': 'the Department of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005608']
1337,34086190,Population Pharmacokinetics and Pharmacodynamics of Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.,"BACKGROUND


Vericiguat, a stimulator of soluble guanylate cyclase, has been developed as a first-in-class therapy for worsening chronic heart failure in adults with left ventricular ejection fraction < 45%.
OBJECTIVE


The objective of this article was to characterize the pharmacokinetics and pharmacokinetic variability of vericiguat combined with guideline-directed medical therapy (standard of care), and identify exposure-response relationships for safety (hemodynamics) and pharmacodynamic markers of efficacy (N-terminal pro-B-type natriuretic peptide concentration [NT-proBNP]) in patients with heart failure and left ventricular ejection fraction < 45% in the SOCRATES-REDUCED study (NCT01951625).
METHODS


Vericiguat and NT-proBNP plasma concentrations in 454 and 432 patients in SOCRATES-REDUCED, respectively, were analyzed using nonlinear mixed-effects modeling.
RESULTS


Vericiguat pharmacokinetics were well described by a one-compartment model with apparent clearance, apparent volume of distribution, and absorption rate constant. Age, bodyweight, plasma bilirubin, and creatinine clearance were identified as significant covariates on apparent clearance; sex and bodyweight on apparent volume of distribution; and bodyweight and plasma albumin level on absorption rate constant. Pharmacokinetic/pharmacodynamic analysis showed initial minor and transient effects of vericiguat on blood pressure with low clinical impact. There were no changes in heart rate following initial or repeated vericiguat administration. An exposure-dependent and time-dependent turnover pharmacokinetic/pharmacodynamic model for NT-proBNP described production and elimination rates and an demonstrated exposure-dependent reduction in [NT-proBNP] by vericiguat plus standard of care compared with placebo plus standard of care. This effect was dependent on baseline [NT-proBNP].
CONCLUSIONS


Vericiguat has predictable pharmacokinetics, with no long-term effects on blood pressure in patients with heart failure and left ventricular ejection fraction < 45%. A pharmacokinetic/pharmacodynamic model described a vericiguat exposure-dependent reduction of NT-proBNP.
CLINICAL TRIAL IDENTIFIER


NCT01951625.",2021,Pharmacokinetic/pharmacodynamic analysis showed initial minor and transient effects of vericiguat on blood pressure with low clinical impact.,"['Patients with Heart Failure and Reduced Ejection Fraction', 'patients with heart failure and left ventricular ejection fraction < 45', '454 and 432 patients in SOCRATES', 'adults with left ventricular ejection fraction < 45', 'patients with heart failure and left ventricular ejection fraction < 45% in the SOCRATES-REDUCED study (NCT01951625']","['placebo', 'vericiguat combined with guideline-directed medical therapy (standard of care']","['heart rate', 'Age, bodyweight, plasma bilirubin, and creatinine clearance', 'apparent clearance; sex and bodyweight on apparent volume of distribution; and bodyweight and plasma albumin level on absorption rate constant', 'volume of distribution, and absorption rate constant', 'blood pressure', 'safety (hemodynamics) and pharmacodynamic markers of efficacy (N-terminal pro-B-type natriuretic peptide concentration [NT-proBNP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0858046', 'cui_str': 'Plasma bilirubin'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1272106', 'cui_str': 'Plasma albumin level'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0692414,Pharmacokinetic/pharmacodynamic analysis showed initial minor and transient effects of vericiguat on blood pressure with low clinical impact.,"[{'ForeName': 'Hauke', 'Initials': 'H', 'LastName': 'Ruehs', 'Affiliation': 'Pharmacometrics, Bayer AG, Aprather Weg 18a, 42113, Wuppertal, Germany.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Klein', 'Affiliation': 'Pharmacometrics, Bayer AG, Aprather Weg 18a, 42113, Wuppertal, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Frei', 'Affiliation': 'Pharmacometrics, Bayer AG, Aprather Weg 18a, 42113, Wuppertal, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Grevel', 'Affiliation': 'BAST Inc. Limited, Loughborough, UK.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Austin', 'Affiliation': 'BAST Inc. Limited, Loughborough, UK.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Clinical Pharmacology, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Clinical Development, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité University Medicine, Campus Virchow-Klinikum, and German Heart Center, Berlin, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Garmann', 'Affiliation': 'Pharmacometrics, Bayer AG, Aprather Weg 18a, 42113, Wuppertal, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Pharmacometrics, Bayer AG, Aprather Weg 18a, 42113, Wuppertal, Germany. michaela.meyer@bayer.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-021-01024-y']
1338,34086101,Long-term effects of lifestyle and metformin interventions in DPP on bone density.,"In the Diabetes Prevention Program Outcome Study (DPPOS), a cohort at high risk of diabetes, randomization to intensive lifestyle intervention or metformin, both associated with weight loss, did not have long-term negative effects on BMD compared with the placebo group. Potential positive effects of metformin on bone warrant further investigation.
INTRODUCTION


Randomization to lifestyle intervention (ILS) or metformin in the Diabetes Prevention Program (DPP) resulted in weight loss and reduced progression to diabetes. Weight loss is associated with reduced bone mineral density (BMD), but the long-term effects of these interventions on BMD are unknown. In the DPP Outcome Study (DPPOS), we determined if randomization to ILS or metformin, compared with placebo, was associated with differences in BMD approximately 16 years later.
METHODS


Of 3234 DPP participants, 2779 continued in DPPOS and were offered ILS in group format. Those randomized to metformin were offered unmasked metformin. At DPPOS year 12, 1367 participants had dual-energy X-ray absorptiometry scans. BMD in metformin and ILS groups was compared to placebo using sex-specific linear regression models, adjusted for age, race/ethnicity, and weight and weight-bearing activity at DPP baseline.
RESULTS


At DPPOS year 12, mean age was 66.5 (±9.5) years. Femoral neck BMD was similar in the ILS and placebo groups in men (difference = -0.021 g/cm 2 , 95%CI (-0.063, 0.021)) and in women (+0.014 g/cm 2 , 95%CI (-0.014, 0.042)). Femoral neck BMD was higher in the metformin compared to placebo group although not statistically different in men (+0.017 g/cm 2 , 95% CI (-0.023, 0.058)) and in women (+0.019 g/cm 2 , 95% CI (-0.009, 0.047)). Prevalence of osteoporosis was low and similar across treatment groups in men (0.9%; p=0.745) and women (2.4%; p=0.466).
CONCLUSION


In a cohort at high risk of diabetes, lifestyle intervention or metformin did not appear to have long-term negative effects on BMD. Potential positive effects of metformin on bone warrant further research.",2021,"Femoral neck BMD was higher in the metformin compared to placebo group although not statistically different in men (+0.017 g/cm 2 , 95% CI (-0.023, 0.058)) and in women (+0.019 g/cm 2 , 95% CI (-0.009, 0.047)).","['1367 participants had dual-energy X-ray absorptiometry scans', 'Of 3234 DPP participants, 2779 continued in DPPOS and were offered']","['metformin', 'lifestyle intervention (ILS) or metformin', 'lifestyle and metformin interventions', 'placebo', 'ILS']","['BMD', 'weight loss', 'weight loss and reduced progression to diabetes', 'bone density', 'Prevalence of osteoporosis', 'Femoral neck BMD', 'Weight loss', 'bone mineral density (BMD']","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]",3234.0,0.0965003,"Femoral neck BMD was higher in the metformin compared to placebo group although not statistically different in men (+0.017 g/cm 2 , 95% CI (-0.023, 0.058)) and in women (+0.019 g/cm 2 , 95% CI (-0.009, 0.047)).","[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Schwartz', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA. Ann.Schwartz@ucsf.edu.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Pan', 'Affiliation': 'Department of Statistics and The Biostatistics Center, George Washington University, Washington, D.C., USA.'}, {'ForeName': 'V R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD, USA.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Albert Einstein College of Medicine, New York City, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kriska', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Piromalli', 'Affiliation': 'Southcentral Foundation, Anchorage, AK, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wallia', 'Affiliation': 'Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Temprosa', 'Affiliation': 'Department of Biostatistics and Bioinformatics and The Biostatistics Center, George Washington University, Washington, D.C., USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Florez', 'Affiliation': 'Department of Public Health Sciences and Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-021-05989-1']
1339,34089152,"Preemptive Intravenous Nalbuphine for the Treatment of Post-Operative Visceral Pain: A Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial.","INTRODUCTION


Post-operative visceral pain is common in early postoperative period after laparoscopic surgery. As a kappa opioid receptor agonist, the antinociceptive effects of nalbuphine in visceral pain are consistent across a multitude of experimental conditions irrespective of species. We hypothesized that preemptive nalbuphine can decrease the visceral pain for patients with incisional infiltration of ropivacaine after laparoscopic cholecystectomy.
METHODS


In a multicenter, prospective, double-blind, placebo-controlled, randomized clinical trial, 2094 participants scheduled for laparoscopic cholecystectomy were randomly assigned to receive nalbuphine (Nal group, n = 1029) or placebo (Con group, n = 1027). The Nal group received intravenous nalbuphine 0.2 mg·kg -1  and the Con group received saline in a similar way. The primary endpoint was the effect of nalbuphine on post-operative visceral pain intensity scores within 24 h postoperatively. The total amount of analgesic as well as complications were recorded.
RESULTS


A total of 1934 participants were analyzed. Nalbuphine reduced the visceral pain both at rest (β = - 0.1189, 95% CI - 0.23 to - 0.01, P = 0.037) and movement (β = - 0.1076, 95% CI - 0.21 to - 0.01, P = 0.040) compared with placebo. Patients in the Nal group required less frequent supplemental analgesic administration during the first 24 h after surgery. There were fewer patients in the Nal group who experienced nausea and vomiting (PONV) (P = 0.008).
CONCLUSIONS


Preemptive nalbuphine administered at a dose of 0.2 mg·kg -1  was safe and effective at reducing the postoperative visceral pain and supplemental analgesic use in patients undergoing laparoscopic cholecystectomy.
TRIAL REGISTRATION


Chinese Clinical Trial Registry; ChiCTR1800014379.",2021,"Nalbuphine reduced the visceral pain both at rest (β = - 0.1189, 95% CI - 0.23 to - 0.01, P = 0.037) and movement (β = - 0.1076, 95% CI - 0.21 to - 0.01, P = 0.040) compared with placebo.","['Post-Operative Visceral Pain', 'patients with incisional infiltration of ropivacaine after laparoscopic cholecystectomy', 'A total of 1934 participants were analyzed', '2094 participants scheduled for laparoscopic cholecystectomy', 'patients undergoing laparoscopic cholecystectomy']","['intravenous nalbuphine 0.2\xa0mg·kg -1  and the Con group received saline', 'nalbuphine (Nal group, n\u2009=\u20091029) or placebo', 'Placebo', 'Nalbuphine', 'preemptive nalbuphine', 'Preemptive Intravenous Nalbuphine', 'placebo', 'Preemptive nalbuphine']","['visceral pain', 'postoperative visceral pain', 'effect of nalbuphine on post-operative visceral pain intensity scores', 'frequent supplemental analgesic administration', 'nausea and vomiting (PONV']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0234245', 'cui_str': 'Visceral pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0234245', 'cui_str': 'Visceral pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",2094.0,0.482716,"Nalbuphine reduced the visceral pain both at rest (β = - 0.1189, 95% CI - 0.23 to - 0.01, P = 0.037) and movement (β = - 0.1076, 95% CI - 0.21 to - 0.01, P = 0.040) compared with placebo.","[{'ForeName': 'Xiaofen', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, and The Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, The Second Hospital of Anhui Medical University, 678 Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, and The Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, The Second Hospital of Anhui Medical University, 678 Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Xianwen', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, and The Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, The Second Hospital of Anhui Medical University, 678 Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, and The Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, The Second Hospital of Anhui Medical University, 678 Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, and The Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, The Second Hospital of Anhui Medical University, 678 Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': 'Department of Anaesthesiology, University of Hong Kong, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, and The Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, The Second Hospital of Anhui Medical University, 678 Furong Road, Hefei, Anhui Province, China. zhangy@ahmu.edu.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pain and therapy,['10.1007/s40122-021-00275-8']
1340,34101714,Neuroprotective effects of intraoperative dexmedetomidine versus saline infusion combined with goal-directed haemodynamic therapy for patients undergoing cranial surgery: A randomised controlled trial.,"BACKGROUND


By inhibiting neuroinflammation dexmedetomidine may be neuroprotective in patients undergoing cranial surgery, but it reduces cardiac output and cerebral blood flow.
OBJECTIVE


To investigate whether intra-operative dexmedetomidine combined with goal-directed haemodynamic therapy (GDHT) has neuroprotective effects in cranial surgery.
DESIGN


A double-blind, single-institution, randomised controlled trial.
SETTING


A single university hospital, from April 2017 to April 2020.
PATIENTS


A total of 160 adults undergoing elective cranial surgery.
INTERVENTION


Infusion of dexmedetomidine (0.5 μg kg-1 h-1) or saline combined with GDHT to optimise stroke volume during surgery.
MAIN OUTCOME MEASURES


The proportion who developed postoperative neurological complications was compared. Postoperative disability was assessed using the Barthel Index at time points between admission and discharge, and also the 30-day modified Rankin Scale (mRS). Postoperative delirium was assessed. The concentration of a peri-operative serum neuroinflammatory mediator, high-mobility group box 1 protein (HMGB1), was compared.
RESULTS


Fewer patients in the dexmedetomidine group developed new postoperative neurological complications (26.3% vs. 43.8%; P = 0.031), but the number of patients developing severe neurological complications was comparable between the two groups (11.3% vs. 20.0%; P = 0.191). In the dexmedetomidine group the Barthel Index reduction [0 (-10 to 0)] was less than that in the control group [-5 (-15 to 0)]; P = 0.023, and there was a more favourable 30-day mRS (P = 0.013) with more patients without postoperative delirium (84.6% vs. 64.2%; P = 0.012). Furthermore, dexmedetomidine induced a significant reduction in peri-operative serum HMGB1 level from the baseline (222.5 ± 408.3 pg ml-1) to the first postoperative day (152.2 ± 280.0 pg ml-1) P = 0.0033. There was no significant change in the control group. The dexmedetomidine group had a lower cardiac index than did the control group (3.0 ± 0.8 vs. 3.4 ± 1.8 l min-1 m-2; P = 0.0482) without lactate accumulation.
CONCLUSIONS


Dexmedetomidine infusion combined with GDHT may mitigate neuroinflammation without undesirable haemodynamic effects during cranial surgery and therefore be neuroprotective.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT02878707.",2021,"Furthermore, dexmedetomidine induced a significant reduction in peri-operative serum HMGB1 level from the baseline (222.5 ± 408.3 pg ml-1) to the first postoperative day (152.2 ± 280.0 pg ml-1)","['A total of 160 adults undergoing elective cranial surgery', 'A single university hospital, from April 2017 to April 2020', 'patients undergoing cranial surgery']","['dexmedetomidine combined with goal-directed haemodynamic therapy (GDHT', 'dexmedetomidine', 'intraoperative dexmedetomidine infusion combined with goal-directed haemodynamic therapy', 'saline combined with GDHT', 'Dexmedetomidine infusion combined with GDHT', 'neuroinflammation dexmedetomidine']","['Postoperative disability', 'postoperative delirium', 'peri-operative serum HMGB1 level', 'favourable 30-day mRS', 'severe neurological complications', 'Postoperative delirium', '30-day modified Rankin Scale (mRS', 'lower cardiac index', 'new postoperative neurological complications', 'postoperative neurological complications', 'cardiac output and cerebral blood flow', 'Barthel Index reduction [0']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",160.0,0.427198,"Furthermore, dexmedetomidine induced a significant reduction in peri-operative serum HMGB1 level from the baseline (222.5 ± 408.3 pg ml-1) to the first postoperative day (152.2 ± 280.0 pg ml-1)","[{'ForeName': 'Pin-Hsin', 'Initials': 'PH', 'LastName': 'Chen', 'Affiliation': 'From the Department of Anaesthesiology, National Taiwan University Hospital, Taipei, Taiwan (P-HC, C-TL, Y-CY, H-LC, T-SL, Y-WC, Y-JC, C-YW) and Division of Neurosurgery, Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan (F-YT).'}, {'ForeName': 'Fon-Yih', 'Initials': 'FY', 'LastName': 'Tsuang', 'Affiliation': ''}, {'ForeName': 'Chen-Tse', 'Initials': 'CT', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Yu-Chang', 'Initials': 'YC', 'LastName': 'Yeh', 'Affiliation': ''}, {'ForeName': 'Hsiao-Liang', 'Initials': 'HL', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Tzong-Shiun', 'Initials': 'TS', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Ya-Wen', 'Initials': 'YW', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Ya-Jung', 'Initials': 'YJ', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Chun-Yu', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001532']
1341,34105396,Evaluation of electroacupuncture for symptom modification in a rodent model of spontaneous osteoarthritis.,"OBJECTIVE


Faced with the frustration of chronic discomfort and restricted mobility due to osteoarthritis (OA), many individuals have turned to acupuncture for relief. However, the efficacy of acupuncture for OA is uncertain, as much of the evidence is inconclusive. The purpose of this study was to evaluate electroacupuncture (EA) in a rodent model of OA such that conclusions regarding its effectiveness for symptom or disease modification could be drawn.
METHODS


Ten 12-month-old male Hartley guinea pigs-which characteristically have moderate to advanced OA at this age-were randomly assigned to receive EA for knee OA (n = 5) or anesthesia only (control group, n = 5). Treatments were performed three times weekly for 3 weeks, followed by euthanasia 2 weeks later. Gait analysis and enclosure monitoring were performed weekly to evaluate changes in movement. Serum was collected for inflammatory biomarker testing. Knee joints were collected for histology and gene expression.
RESULTS


Animals receiving EA had significantly greater changes in movement parameters compared to those receiving anesthesia only. There was a tendency toward decreased serum protein concentrations of complement component 3 (C3) in the EA group compared to the control group. Structural and antioxidant gene transcripts in articular cartilage were increased by EA. There was no significant difference in total joint histology scores between groups.
CONCLUSION


This study provides evidence that EA has a positive effect on symptom, but not disease, modification in a rodent model of OA. Further investigations into mechanistic pathways that may explain the efficacy of EA in this animal model are needed.",2021,There was a tendency toward decreased serum protein concentrations of complement component 3 (C3) in the EA group compared to the control group.,"['Ten 12-month-old male Hartley guinea pigs-which characteristically have moderate to advanced OA at this age', 'osteoarthritis (OA']","['acupuncture', 'EA for knee OA (n = 5) or anesthesia', 'electroacupuncture', 'electroacupuncture (EA']","['movement parameters', 'serum protein concentrations', 'Structural and antioxidant gene transcripts in articular cartilage', 'total joint histology scores']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0324525', 'cui_str': 'Hartley guinea pig'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036825', 'cui_str': 'Serum protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0007303', 'cui_str': 'Structure of articular cartilage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0453391,There was a tendency toward decreased serum protein concentrations of complement component 3 (C3) in the EA group compared to the control group.,"[{'ForeName': 'Alexa P', 'Initials': 'AP', 'LastName': 'Spittler', 'Affiliation': 'Department of Microbiology, Immunology, & Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Maryam F', 'Initials': 'MF', 'LastName': 'Afzali', 'Affiliation': 'Department of Microbiology, Immunology, & Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Martinez', 'Affiliation': 'Department of Microbiology, Immunology, & Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Culver', 'Affiliation': 'Department of Microbiology, Immunology, & Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Leavell', 'Affiliation': 'Department of Microbiology, Immunology, & Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Ariel E', 'Initials': 'AE', 'LastName': 'Timkovich', 'Affiliation': 'Department of Microbiology, Immunology, & Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Sanford', 'Affiliation': 'Department of Microbiology, Immunology, & Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Melinda R', 'Initials': 'MR', 'LastName': 'Story', 'Affiliation': 'Department of Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Kelly S', 'Initials': 'KS', 'LastName': 'Santangelo', 'Affiliation': 'Department of Microbiology, Immunology, & Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO, USA.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/09645284211020755']
1342,34109485,Brain connectivity markers in advanced Parkinson's disease for predicting mild cognitive impairment.,"OBJECTIVES


Mild cognitive impairment (MCI) is a well-defined non-motor manifestation and a harbinger of dementia in Parkinson's disease. This study is to investigate brain connectivity markers of MCI using diffusion tensor imaging and resting-state functional MRI, and help MCI diagnosis in PD patients.
METHODS


We evaluated 131 advanced PD patients (disease duration > 5 years; 59 patients with MCI) and 48 healthy control subjects who underwent a diffusion-weighted and resting-state functional MRI scanning. The patients were randomly assigned to training (n = 100) and testing (n = 31) groups. According to the Brainnetome Atlas, ROI-based structural and functional connectivity analysis was employed to extract connectivity features. To identify features with significant discriminative power for patient classification, all features were put into an all-relevant feature selection procedure within cross-validation loops.
RESULTS


Nine features were identified to be significantly relevant to patient classification. They showed significant differences between PD patients with and without MCI and positively correlated with the MoCA score. Five of them did not differ between general MCI subjects and healthy controls from the ADNI database, which suggested that they could uniquely play a part in the MCI diagnosis of PD. On basis of these relevant features, the random forest model constructed from the training group achieved an accuracy of 83.9% in the testing group, to discriminate patients with and without MCI.
CONCLUSIONS


The results of our study provide preliminary evidence that structural and functional connectivity abnormalities may contribute to cognitive impairment and allow to predict the outcome of MCI diagnosis in PD.
KEY POINTS


• Nine MCI markers were identified using an all-relevant feature selection procedure. • Five of nine markers differed between MCI and NC in PD, but not in general persons. • A random forest model achieved an accuracy of 83.9% for MCI diagnosis in PD.",2021,"On basis of these relevant features, the random forest model constructed from the training group achieved an accuracy of 83.9% in the testing group, to discriminate patients with and without MCI.
","[""advanced Parkinson's disease for predicting mild cognitive impairment"", '131 advanced PD patients (disease duration > 5 years; 59 patients with MCI) and 48 healthy control subjects who underwent a diffusion-weighted and resting-state functional MRI scanning', 'PD patients']",[],['MoCA score'],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",[],"[{'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}]",131.0,0.0406964,"On basis of these relevant features, the random forest model constructed from the training group achieved an accuracy of 83.9% in the testing group, to discriminate patients with and without MCI.
","[{'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ""Department of Neurosurgery, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, 3002# Sungang West Road, Futian District, Shenzhen, 518035, China.""}, {'ForeName': 'Zesi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, 3002# Sungang West Road, Futian District, Shenzhen, 518035, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Brain Cognition and Brain Disease Institute, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, China.'}, {'ForeName': 'Doudou', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, 3002# Sungang West Road, Futian District, Shenzhen, 518035, China.""}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, 3002# Sungang West Road, Futian District, Shenzhen, 518035, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Neurosurgery, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, 3002# Sungang West Road, Futian District, Shenzhen, 518035, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Neurosurgery, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, 3002# Sungang West Road, Futian District, Shenzhen, 518035, China.""}, {'ForeName': 'Qiusheng', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, 3002# Sungang West Road, Futian District, Shenzhen, 518035, China. shinezqs@163.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': ""Department of Neurosurgery, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, 3002# Sungang West Road, Futian District, Shenzhen, 518035, China. 13632660199@139.com.""}]",European radiology,['10.1007/s00330-021-08086-3']
1343,34108078,"The 90% Effective Dose of Sufentanil for Epidural Analgesia in the Early First Stage of Labor: A Double-blind, Sequential Dose-Finding Study.","PURPOSE


Epidural analgesia in the latent phase of the first stage of labor has been recognized and accepted by anesthesiologists worldwide. However, there is no unified consensus on the exact dosage of sufentanil with the combination of ropivacaine in the induction of epidural analgesia in the early first stage of labor. In this sequential dose-finding study, the 90% effective dose (ED 90 ) of sufentanil for epidural administration in the early first stage of labor was estimated to minimize the adverse effects of using higher doses.
METHODS


Forty parturients with cervical dilatation of 2 to 4 cm who requested epidural analgesia were enrolled in this study. Parturients received 15 mL of a combination of ropivacaine 13 mg and the test dose of sufentanil. The initial dose of sufentanil in epidural administration was 1 μg, and the dose of sufentanil for the next parturient was based on the response of the preceding participant as per a biased coin up-and-down design. The primary outcome was the dose of sufentanil that resulted in successful epidural administration by maintaining the parturients' visual analog scale scores at ≤30 mm in the first 15, 30, and 45 minutes of induction. The ED 90  and 95% CIs were estimated using isotonic regression methods and bootstrapping.
FINDINGS


The estimated ED 90  of sufentanil in epidural administration in the early first stage of labor was 1.91 μg (95% CI, 1.82-2.35 μg) in this sequential dose-finding study.
IMPLICATIONS


Sufentanil at a dosage of 2 μg is recommended for the administration of epidural analgesia in parturients in the early first stage of labor. ChiCTR.org.cn identifier: 1900021683.",2021,"The primary outcome was the dose of sufentanil that resulted in successful epidural administration by maintaining the parturients' visual analog scale scores at ≤30 mm in the first 15, 30, and 45 minutes of induction.","['Forty parturients with cervical dilatation of 2 to 4 cm who requested epidural analgesia were enrolled in this study', 'parturients in the early first stage of labor']","['sufentanil', 'ropivacaine', 'Sufentanil']","[""successful epidural administration by maintaining the parturients' visual analog scale scores""]","[{'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.154391,"The primary outcome was the dose of sufentanil that resulted in successful epidural administration by maintaining the parturients' visual analog scale scores at ≤30 mm in the first 15, 30, and 45 minutes of induction.","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China; Shanghai Key Laboratory of Embryo Original Diseases, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China; Shanghai Key Laboratory of Embryo Original Diseases, Shanghai, China.'}, {'ForeName': 'Zifeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China; Shanghai Key Laboratory of Embryo Original Diseases, Shanghai, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Key Laboratory of Embryo Original Diseases, Shanghai, China; Department of Biostatistics, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Shanghai Key Laboratory of Embryo Original Diseases, Shanghai, China; Department of Labor Room, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. Electronic address: woaiwojia217918@163.com.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China; Shanghai Key Laboratory of Embryo Original Diseases, Shanghai, China. Electronic address: towerxutao@163.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2021.05.002']
1344,34050768,"Posaconazole for prevention of invasive pulmonary aspergillosis in critically ill influenza patients (POSA-FLU): a randomised, open-label, proof-of-concept trial.","PURPOSE


Influenza-associated pulmonary aspergillosis (IAPA) is a frequent complication in critically ill influenza patients, associated with significant mortality. We investigated whether antifungal prophylaxis reduces the incidence of IAPA.
METHODS


We compared 7 days of intravenous posaconazole (POS) prophylaxis with no prophylaxis (standard-of-care only, SOC) in a randomised, open-label, proof-of-concept trial in patients admitted to an intensive care unit (ICU) with respiratory failure due to influenza (ClinicalTrials.gov, NCT03378479). Adult patients with PCR-confirmed influenza were block randomised (1:1) within 10 days of symptoms onset and 48 h of ICU admission. The primary endpoint was the incidence of IAPA during ICU stay in patients who did not have IAPA within 48 h of ICU admission (modified intention-to-treat (MITT) population).
RESULTS


Eighty-eight critically ill influenza patients were randomly allocated to POS or SOC. IAPA occurred in 21 cases (24%), the majority of which (71%, 15/21) were diagnosed within 48 h of ICU admission, excluding them from the MITT population. The incidence of IAPA was not significantly reduced in the POS arm (5.4%, 2/37) compared with SOC (11.1%, 4/36; between-group difference 5.7%; 95% CI - 10.8 to 21.7; p = 0.32). ICU mortality of early IAPA was high (53%), despite rapid antifungal treatment.
CONCLUSION


The higher than expected incidence of early IAPA precludes any definite conclusion on POS prophylaxis. High mortality of early IAPA, despite timely antifungal therapy, indicates that alternative management strategies are required. After 48 h, still 11% of patients developed IAPA. As these could benefit from prophylaxis, differentiated strategies are likely needed to manage IAPA in the ICU.",2021,"The incidence of IAPA was not significantly reduced in the POS arm (5.4%, 2/37) compared with SOC (11.1%, 4/36; between-group difference 5.7%; 95% CI - 10.8 to 21.7; p = 0.32).","['Eighty-eight critically ill influenza patients', 'patients admitted to an intensive care unit (ICU) with respiratory failure due to influenza (ClinicalTrials.gov, NCT03378479', 'critically ill influenza patients (POSA-FLU', 'patients who did not have IAPA within 48\xa0h of ICU admission (modified intention-to-treat (MITT) population', 'critically ill influenza patients', 'Adult patients with PCR-confirmed influenza']","['intravenous posaconazole (POS) prophylaxis with no prophylaxis (standard-of-care only, SOC', 'POS or SOC', 'Posaconazole']","['ICU mortality of early IAPA', 'incidence of IAPA during ICU stay', 'IAPA', 'incidence of IAPA']","[{'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2350529', 'cui_str': 'Pulmonary aspergillosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0936148', 'cui_str': 'posaconazole'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2350529', 'cui_str': 'Pulmonary aspergillosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",88.0,0.0704603,"The incidence of IAPA was not significantly reduced in the POS arm (5.4%, 2/37) compared with SOC (11.1%, 4/36; between-group difference 5.7%; 95% CI - 10.8 to 21.7; p = 0.32).","[{'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Vanderbeke', 'Affiliation': 'Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Nico A F', 'Initials': 'NAF', 'LastName': 'Janssen', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Dennis C J J', 'Initials': 'DCJJ', 'LastName': 'Bergmans', 'Affiliation': 'Department of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bourgeois', 'Affiliation': 'Department of Intensive Care, Algemeen Ziekenhuis Sint-Jan Brugge-Oostende, Brugge, Belgium.'}, {'ForeName': 'Jochem B', 'Initials': 'JB', 'LastName': 'Buil', 'Affiliation': 'Center of Expertise in Mycology Radboudumc/CWZ, Radboudumc Center for Infectious Diseases (RCI), Nijmegen, The Netherlands.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Debaveye', 'Affiliation': 'Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Depuydt', 'Affiliation': 'Department of Intensive Care Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Feys', 'Affiliation': 'Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Hermans', 'Affiliation': 'Medical Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Hoiting', 'Affiliation': 'Department of Intensive Care Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'van der Hoven', 'Affiliation': 'Department of Intensive Care Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Cato', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': 'Medical Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Lagrou', 'Affiliation': 'Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Lemiale', 'Affiliation': 'Department of Intensive Care Medicine, Saint-Louis Hospital, Paris, France.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Lormans', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Algemeen Ziekenhuis Delta, Roeselare, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Maertens', 'Affiliation': 'Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Meersseman', 'Affiliation': 'Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Mégarbane', 'Affiliation': 'Department of Medical and Toxicological Critical Care, Lariboisière Hospital, INSERM UMRS-1144, University of Paris, Paris, France.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Nseir', 'Affiliation': 'Department of Intensive Care Medicine, Critical Care Center, University Hospital Lille, INSERM U995-E2, Lille Inflammation Research International Center, University of Lille, Lille, France.'}, {'ForeName': 'Jos A H', 'Initials': 'JAH', 'LastName': 'van Oers', 'Affiliation': 'Department of Intensive Care Medicine, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Reynders', 'Affiliation': 'Department of Laboratory Medicine, Algemeen Ziekenhuis Sint-Jan Brugge-Oostende, Brugge, Belgium.'}, {'ForeName': 'Bart J A', 'Initials': 'BJA', 'LastName': 'Rijnders', 'Affiliation': 'Department of Internal Medicine, Section of Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jeroen A', 'Initials': 'JA', 'LastName': 'Schouten', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Spriet', 'Affiliation': 'Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Thevissen', 'Affiliation': 'Department of Microbial and Molecular Systems, Center of Microbial and Plant Genetics (CMPG), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital Poitiers, Poitiers, France.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Van Daele', 'Affiliation': 'Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'van de Veerdonk', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Verweij', 'Affiliation': 'Center of Expertise in Mycology Radboudumc/CWZ, Radboudumc Center for Infectious Diseases (RCI), Nijmegen, The Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wilmer', 'Affiliation': 'Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Roger J M', 'Initials': 'RJM', 'LastName': 'Brüggemann', 'Affiliation': 'Center of Expertise in Mycology Radboudumc/CWZ, Radboudumc Center for Infectious Diseases (RCI), Nijmegen, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Wauters', 'Affiliation': 'Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium. joost.wauters@uzleuven.be.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-021-06431-0']
1345,34051122,Tapentadol results in less deterioration of gastrointestinal function and symptoms than standard opioid therapy in healthy male volunteers.,"BACKGROUND


Tapentadol is a combined opioid agonist and norepinephrine reuptake inhibitor with fewer gastrointestinal side effects at equianalgesic doses compared with classical strong opioids. Previous studies on tapentadol have included multi-morbid patients in whom confounders exclude detailed assessment of the mechanistic effects and strict comparison with other opioids or placebo. This study aimed at investigating the effects of tapentadol and oxycodone on gastrointestinal motility and gastrointestinal side effects.
METHODS


21 healthy males participated in a randomized, double-blind, placebo-controlled, crossover study. Tapentadol (50 mg twice daily), oxycodone (10 mg twice daily), or placebo tablets were administered for 14 days. Segmental gastrointestinal transit times and colonic motility parameters were measured with electromagnetic capsules. Gastrointestinal side effects were assessed using questionnaires.
KEY RESULTS


During dosing with tapentadol, gastrointestinal side effects and motility parameters were on placebo level. Compared with tapentadol, oxycodone increased whole gut transit time by 17.9 hours (p = .015) and rectosigmoid transit time by 6.5 hours (p = .005). Compared with tapentadol, oxycodone also reduced long, fast antegrade colonic movements (p = .001). In comparison with placebo, oxycodone prolonged whole gut transit time by 31.6 hours, (p < .001). Moreover, less long, fast antegrade colonic movements (p = .002) were observed during oxycodone. For oxycodone only, slow colonic movements were associated with gastrointestinal side effects.
CONCLUSIONS & INFERENCES


In this mechanistic study, tapentadol caused significantly less colonic dysmotility and gastrointestinal side effects as compared with oxycodone in equianalgesic doses.",2021,"Moreover, less long, fast antegrade colonic movements (p = .002) were observed during oxycodone.","['healthy male volunteers', '21 healthy males']","['tapentadol', 'standard opioid therapy', 'placebo', 'Tapentadol', 'oxycodone', 'tapentadol, oxycodone', 'placebo, oxycodone', 'placebo tablets', 'tapentadol and oxycodone']","['colonic dysmotility and gastrointestinal side effects', 'Gastrointestinal side effects', 'whole gut transit time', 'gut transit time', 'rectosigmoid transit time', 'fast antegrade colonic movements', 'gastrointestinal function and symptoms', 'long, fast antegrade colonic movements', 'gastrointestinal motility and gastrointestinal side effects', 'Segmental gastrointestinal transit times and colonic motility parameters']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C2001271', 'cui_str': 'tapentadol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521377', 'cui_str': 'Rectosigmoid structure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0232484', 'cui_str': 'Gastrointestinal transit time'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",21.0,0.024667,"Moreover, less long, fast antegrade colonic movements (p = .002) were observed during oxycodone.","[{'ForeName': 'Esben Bolvig', 'Initials': 'EB', 'LastName': 'Mark', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Rasmus Bach', 'Initials': 'RB', 'LastName': 'Nedergaard', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Tine Maria', 'Initials': 'TM', 'LastName': 'Hansen', 'Affiliation': 'Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Thomas Dahl', 'Initials': 'TD', 'LastName': 'Nissen', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens Brøndum', 'Initials': 'JB', 'LastName': 'Frøkjaer', 'Affiliation': 'Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'S Mark', 'Initials': 'SM', 'LastName': 'Scott', 'Affiliation': 'Neurogastroenterology Group (GI Physiology Unit), Centre for Neuroscience, Surgery & Trauma, Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Krogh', 'Affiliation': 'Neurogastroenterology Unit, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Asbjørn Mohr', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14131']
1346,34051120,Randomized controlled trial of home biofeedback therapy versus office biofeedback therapy for fecal incontinence.,"BACKGROUND


Biofeedback therapy is useful for treatment of fecal incontinence (FI), but is not widely available and labor intensive. We investigated if home biofeedback therapy (HBT) is non-inferior to office biofeedback therapy (OBT).
METHODS


Patients with FI (≥1 episode/week) were randomized to HBT or OBT for 6 weeks. HBT was performed daily using novel device that provided resistance training and electrical stimulation with voice-guided instructions. OBT consisted of six weekly sessions. Both methods involved anal strength, endurance, and coordination training. Primary outcome was change in weekly FI episodes. FI improvement was assessed with stool diaries, validated instruments (FISI, FISS, and ICIQ-B), and anorectal manometry using intention-to-treat analysis.
KEY RESULTS


Thirty (F/M = 26/4) FI patients (20 in HBT, 10 in OBT) participated. Weekly FI episodes decreased significantly after HBT (Δ ± 95% confidence interval: 4.7 ± 1.8, compared with baseline, p = 0.003) and OBT (3.7 ± 1.6, p = 0.0003) and HBT was non-inferior to OBT (p = 0.2). The FISI and FISS scores improved significantly in HBT group (p < 0.02). Bowel pattern, bowel control, and quality of life (QOL) domains (ICIQ-B) improved significantly in HBT arm (p < 0.023). Resting and maximum squeeze sphincter pressures significantly improved in both HBT and OBT groups and sustained squeeze pressure in HBT, without group differences.
CONCLUSIONS & INFERENCES


Home biofeedback therapy is non-inferior to OBT for FI treatment. Home biofeedback is safe, effective, improves QOL, and through increased access could facilitate improved management of FI.",2021,"Resting and maximum squeeze sphincter pressures significantly improved in both HBT and OBT groups and sustained squeeze pressure in HBT, without group differences.
","['Patients with FI (≥1 episode/week', 'Thirty (F/M\xa0=\xa026/4', 'fecal incontinence']","['HBT', 'home biofeedback therapy versus office biofeedback therapy', 'Biofeedback therapy', 'HBT and OBT', 'home biofeedback therapy (HBT', 'HBT or OBT']","['change in weekly FI episodes', 'HBT', 'stool diaries, validated instruments (FISI, FISS, and ICIQ-B), and anorectal manometry using intention-to-treat analysis', 'Resting and maximum squeeze sphincter pressures', 'Weekly FI episodes', 'anal strength, endurance, and coordination training', 'OBT', 'Bowel pattern, bowel control, and quality of life (QOL) domains (ICIQ-B', 'safe, effective, improves QOL', 'FISI and FISS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0419112', 'cui_str': 'Coordination training'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1290944', 'cui_str': 'Anorectal continence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0838235,"Resting and maximum squeeze sphincter pressures significantly improved in both HBT and OBT groups and sustained squeeze pressure in HBT, without group differences.
","[{'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Tanisa', 'Initials': 'T', 'LastName': 'Patcharatrakul', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Tennekoon', 'Initials': 'T', 'LastName': 'Karunaratne', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Parr', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Deepak Nag', 'Initials': 'DN', 'LastName': 'Ayyala', 'Affiliation': 'Department of Population Health Sciences, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Department of Population Health Sciences, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14168']
1347,34059737,Effect of smartphone-based stress management programs on depression and anxiety of hospital nurses in Vietnam: a three-arm randomized controlled trial.,"There are growing concerns on stress among nurses in low- and middle-income countries (LMICs) in South-East Asia. It is important to improve mental health among nurses in these countries. The objective of this study was to examine the efficacy of two types of newly developed smartphone-based stress management programs in improving depressive and anxiety symptoms among hospital nurses in Vietnam. This study was a three-arm (including two intervention groups and one control group) randomized trial. Participants were recruited from nurses in a large general hospital in Hanoi, Vietnam. Two types (free-choice and fixed sequential order) of smartphone-based stress management programs were developed. Participants were randomly allocated to Program A (a free-choice, multimodule stress management), Program B (a fixed-order, internet cognitive behavioral therapy, iCBT), or a control group (treatment as usual). The depressive and anxiety symptoms were measured by using the Depression Anxiety and Stress Scales at baseline, 3-, and 7-month follow-up surveys. 951 participants were randomly allocated to each of the three groups. Program B showed a statistically significant effect on improving depressive symptoms at 3-month (p = 0.048), but not at 7-month (p = 0.92); Cohen's d was - 0.18 (95% CI - 0.34 to - 0.02) and 0.03 (95% CI - 1.00 to 1.05), respectively. Program A failed to show a significant intervention effect on any of the outcomes at 3- or 7-month follow-up (p > 0.05). Despite the small effect size, the present fixed-order iCBT program seems effective in improving depression of hospital nurses in Vietnam. A public health impact of the intervention can be scalable, when considering its accessibility and minimal cost.Trial registration number: The study protocol is registered at the UMIN Clinical Trials Registry (UMINCTR; ID = UMIN000033139). Registered date of the protocol is 1st Jul. 2018. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037796.",2021,"Program B showed a statistically significant effect on improving depressive symptoms at 3-month (p = 0.048), but not at 7-month (p = 0.92); Cohen's d was - 0.18 (95% CI - 0.34 to - 0.02) and 0.03 (95% CI - 1.00 to 1.05), respectively.","['hospital nurses in Vietnam', 'Participants were recruited from nurses in a large general hospital in Hanoi, Vietnam', '951 participants']","['smartphone-based stress management programs', 'Program A (a free-choice, multimodule stress management), Program B (a fixed-order, internet cognitive behavioral therapy, iCBT), or a control group (treatment as usual']","['depression and anxiety', 'depressive symptoms', 'Depression Anxiety and Stress Scales', 'depressive and anxiety symptoms']","[{'cui': 'C1271036', 'cui_str': 'Hospital nurse'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",951.0,0.0277235,"Program B showed a statistically significant effect on improving depressive symptoms at 3-month (p = 0.048), but not at 7-month (p = 0.92); Cohen's d was - 0.18 (95% CI - 0.34 to - 0.02) and 0.03 (95% CI - 1.00 to 1.05), respectively.","[{'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Imamura', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Thuy Thi Thu', 'Initials': 'TTT', 'LastName': 'Tran', 'Affiliation': 'Department of Occupational Health and Safety, Faculty of Environmental and Occupational Health, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Huong Thanh', 'Initials': 'HT', 'LastName': 'Nguyen', 'Affiliation': 'Faculty of Social and Behavioral Sciences, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Natsu', 'Initials': 'N', 'LastName': 'Sasaki', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Kuribayashi', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Graduate School of Health Care Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Sakuraya', 'Affiliation': ""Division of Public Health, Department of Hygiene and Public Health, School of Medicine, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Thu Minh', 'Initials': 'TM', 'LastName': 'Bui', 'Affiliation': 'Nursing Office, Bach Mai Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Anh Quoc', 'Initials': 'AQ', 'LastName': 'Nguyen', 'Affiliation': 'Bach Mai hospital, Hanoi, Vietnam.'}, {'ForeName': 'Quynh Thuy', 'Initials': 'QT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Occupational Health and Safety, Faculty of Environmental and Occupational Health, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Nga Thi', 'Initials': 'NT', 'LastName': 'Nguyen', 'Affiliation': 'Faculty of Social and Behavioral Sciences, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Kien Trung', 'Initials': 'KT', 'LastName': 'Nguyen', 'Affiliation': 'Faculty of Social and Behavioral Sciences, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Giang Thi Huong', 'Initials': 'GTH', 'LastName': 'Nguyen', 'Affiliation': 'Nursing Office, Bach Mai Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Xuyen Thi Ngoc', 'Initials': 'XTN', 'LastName': 'Tran', 'Affiliation': 'Nursing Office, Bach Mai Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Tien Quang', 'Initials': 'TQ', 'LastName': 'Truong', 'Affiliation': 'Faculty of Social and Behavioral Sciences, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Melvyn Weibin', 'Initials': 'MW', 'LastName': 'Zhang', 'Affiliation': 'National Addiction Management Service, Institute of Mental Health, Singapore, Singapore.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Minas', 'Affiliation': 'Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sekiya', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Public Health, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Akizumi', 'Initials': 'A', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Public Health, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakami', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. nkawakami@m.u-tokyo.ac.jp.'}]",Scientific reports,['10.1038/s41598-021-90320-5']
1348,34059720,A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin.,"Sodium-glucose cotranspsorter-2 (SGLT2) inhibitors (SGLT2i) involve loss of skeletal muscle mass, potentially leading to inadequate HbA1c reduction in type 2 diabetes (T2DM), since muscle mass is related to insulin sensitivity. The benefit of protein-enriched diet for improving HbA1c in SGLT2i-treated T2DM patients remains unclear. We conducted a multicenter, double-blind, randomized, controlled, investigator-initiated clinical trial. 130 T2DM patients treated with dapagliflozin (5 mg) were randomized to isoenergic protein-rich formula diet (P-FD) or fat-rich FD (F-FD) (1:1 allocation) to replace one of three meals/day for 24 weeks. Primary outcome was change in HbA1c. Secondary outcomes were changes in serum insulin, body composition and other metabolic parameters. Although HbA1c decreased significantly in both groups [mean (95% confidence interval) - 0.7% (- 0.9 to - 0.5) in P-FD, - 0.6% (- 0.8 to - 0.5) in F-FD], change in HbA1c was not significantly different between the two groups (P = 0.4474). Fasting insulin and body fat mass decreased, while HDL-cholesterol increased significantly in P-FD, and these changes were significantly greater compared with F-FD (all, P < 0.05). In T2DM treated with dapagliflozin, protein-enriched diet does not contribute to HbA1c reduction, although it decreases serum insulin and body fat mass, and increases HDL-cholesterol compared with fat-enriched diet with identical calories and carbohydrate ratio.",2021,"Fasting insulin and body fat mass decreased, while HDL-cholesterol increased significantly in P-FD, and these changes were significantly greater compared with F-FD (all, P < 0.05).","['patients with type 2 diabetes treated with', '130 T2DM patients treated with']","['protein-enriched diet', 'Sodium-glucose cotranspsorter-2', 'dapagliflozin, protein-enriched diet', 'isoenergic protein-rich formula diet (P-FD) or fat-rich FD (F-FD', 'dapagliflozin', 'SGLT2) inhibitors (SGLT2i', 'diets enriched with protein or fat']","['Fasting insulin and body fat mass decreased, while HDL-cholesterol', 'changes in serum insulin, body composition and other metabolic parameters', 'serum insulin and body fat mass, and increases HDL-cholesterol', 'change in HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0853084', 'cui_str': 'High density lipoprotein increased'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",130.0,0.0435424,"Fasting insulin and body fat mass decreased, while HDL-cholesterol increased significantly in P-FD, and these changes were significantly greater compared with F-FD (all, P < 0.05).","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura-shi, Chiba, 285-8741, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Suzuki', 'Affiliation': 'Suzuki Diabetes Clinic, 1-3-24 Aikoh, Atsugi-shi, Kanagawa, 243-0035, Japan.'}, {'ForeName': 'Nobuichi', 'Initials': 'N', 'LastName': 'Kuribayashi', 'Affiliation': 'Misaki Naika Clinic, 6-44-9 Futawahigashi, Funabashi-shi, Chiba, 274-0805, Japan.'}, {'ForeName': 'Daigaku', 'Initials': 'D', 'LastName': 'Uchida', 'Affiliation': 'Hotaruno Central Naika, 3-30-3 Hotaruno, Kisarazu-shi, Chiba, 292-0038, Japan.'}, {'ForeName': 'Mitsutoshi', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Kato Clinic of Internal Medicine, 3-11-14 Takasago, Katsushika-Ku, Tokyo, 125-0054, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ohashi', 'Affiliation': 'Oyama East Clinic, 1-32-1 Ekihigashidori, Oyama-shi, Tochigi, 323-0022, Japan.'}, {'ForeName': 'Daiji', 'Initials': 'D', 'LastName': 'Nagayama', 'Affiliation': 'Nagayama Clinic, 2-12-22 Tenjincho, Oyama-shi, Tochigi, 323-0032, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura-shi, Chiba, 285-8741, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ohira', 'Affiliation': 'Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura-shi, Chiba, 285-8741, Japan.'}, {'ForeName': 'Atsuhito', 'Initials': 'A', 'LastName': 'Saiki', 'Affiliation': 'Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura-shi, Chiba, 285-8741, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Tatsuno', 'Affiliation': 'Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura-shi, Chiba, 285-8741, Japan. ichirotatsuno@gmail.com.'}]",Scientific reports,['10.1038/s41598-021-90879-z']
1349,34059692,Therapeutic effects and prognostic factors of  125 I brachytherapy for pelvic recurrence after early cervical cancer surgery.,"To investigate the efficacy of  125 I seed implantation in the treatment regimen of pelvic recurrence after early cervical cancer surgery and to analyse prognostic factors. To evaluate efficacy and analyse prognostic factors of  125 I seed implantation for pelvic recurrence after early cervical cancer surgery. A prospective study was conducted on 62 patients who experienced pelvic recurrence after early cervical cancer surgery between August 2005 and September 2015. The 62 patients were treated and assessed in 2 groups (n = 30). All 62 patients were randomized into two groups that received two different treatment regimens: the treatment group (n = 30), which received  125 I particle implantation therapy, and the control group (n = 32), which received whole-pelvic irradiation using the anteroposterior/posteroanterior field and cisplatin-based concurrent chemoradiation therapy. The efficacy/efficiency of  125 I seed implantation and prognostic factors were analysed by logistic regression. Overall survival was determined by Kaplan-Meier analysis. Multivariate analysis results were obtained by the Cox proportional hazards regression model. The effective control rates at 1, 3, 6 and 12 months were 76.7%, 80.0%, 83.3%, and 86.7% in the  125 I particle implantation group. The total effective control rates at 1, 3, 6 and 12 months were 65.6%, 65.5%, 62.5%, and 71.9% in the chemoradiotherapy group. Significant differences were observed between the two groups. The overall survival rates at 1, 2, 3, 4, and 5 years and the median overall were 96.7%, 93.3%, 86.7%, 71.9%, 65.6% and 4.34 years, respectively, in the  125 I seed implantation group and 81.3%, 71.9%, 62.5%, 56.3%, 53.1% and 3.59 years, respectively, in the control group. There were statistically significant differences in survival rates depending on the diameter of the largest recurrent pelvic tumour (χ 2  = 6.611, P = 0.010). The multivariate analysis showed that the survival rates were related to the diameter of the largest recurrent pelvic tumour (χ 2  = 4.538, P = 0.033).  125 I implantation is an effective, safe, and promising method for the treatment of pelvic recurrence after early cervical cancer surgery. The diameter of the recurrent pelvic tumour was identified as a significant independent prognostic factor in patients who received  125 I implantation.",2021,"There were statistically significant differences in survival rates depending on the diameter of the largest recurrent pelvic tumour (χ 2  = 6.611, P = 0.010).","['pelvic recurrence after early cervical cancer surgery', 'All 62 patients', '125', '62 patients who experienced pelvic recurrence after early cervical cancer surgery between August 2005 and September 2015', '62 patients were treated and assessed in 2 groups (n\u2009=\u200930']","['125 I particle implantation therapy, and the control group (n\u2009=\u200932), which received whole-pelvic irradiation using the anteroposterior/posteroanterior field and cisplatin-based concurrent chemoradiation therapy', 'I brachytherapy', 'chemoradiotherapy', 'I seed implantation']","['efficacy/efficiency of', 'effective control rates', 'median overall', 'overall survival rates', 'survival rates', 'Overall survival', 'total effective control rates']","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",62.0,0.0550517,"There were statistically significant differences in survival rates depending on the diameter of the largest recurrent pelvic tumour (χ 2  = 6.611, P = 0.010).","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, 510080, Guangdong, China.'}, {'ForeName': 'Jinhu', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Gynecology, GuangZhou Red Cross Hospital, Jinan University, Guangzhou, 510220, Guangdong, China. zhujinhu421@163.com.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, 510080, Guangdong, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Gynecology, GuangZhou Red Cross Hospital, Jinan University, Guangzhou, 510220, Guangdong, China.'}, {'ForeName': 'Cairu', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'Department of Gynecology, GuangZhou Red Cross Hospital, Jinan University, Guangzhou, 510220, Guangdong, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liang', 'Affiliation': 'Department of Gynecology, GuangZhou Red Cross Hospital, Jinan University, Guangzhou, 510220, Guangdong, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Gynecology, GuangZhou Red Cross Hospital, Jinan University, Guangzhou, 510220, Guangdong, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecology, GuangZhou Red Cross Hospital, Jinan University, Guangzhou, 510220, Guangdong, China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, 510080, Guangdong, China.'}]",Scientific reports,['10.1038/s41598-021-90007-x']
1350,34074291,Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty: an open-label randomized control trial.,"BACKGROUND


The postoperative pain after total knee arthroplasty (TKA) remains a critical issue. The aim of this study was to assess the clinical effectiveness of percutaneous periarticular injection at 1 day following simultaneous bilateral TKA.
METHODS


A total of 88 knees in 44 patients who underwent simultaneous bilateral TKA were randomly assigned to receive a percutaneous periarticular injection at 1 day following surgery (n = 22 patients) or no injection (n = 22 patients). In the additional injection group, we injected a solution including methylprednisolone, ropivacaine, and epinephrine into the muscle belly of the vastus medialis at 1 day after surgery. In both groups, patients received an intraoperative periarticular multi-drug injection and postoperative intravenous and oral nonsteroidal anti-inflammatory drugs. The primary outcome measure was the postoperative pain at rest using a visual analog scale (VAS) and analyzed with Student's t test.
RESULTS


Compared to the no additional injection group, the additional periarticular injection group had significantly lower VAS score at 8:00 PM postoperative day 1, 6:00 AM postoperative day 2, 12:00 PM postoperative day 2, 6:00 AM postoperative day 5, 12:00 PM postoperative day 5, and 8:00 PM postoperative day 5 (p < 0.05). The rate of complication did not differ between groups (p > 0.05).
CONCLUSION


Additional percutaneous periarticular injection at 1 day following TKA adding to intraoperative periarticular injection provided better postoperative pain relief.
TRIAL REGISTRATION


Registered at the University Hospital Medical Information Network (registration number: UMIN000029759 ).",2021,"The rate of complication did not differ between groups (p > 0.05).
","['A total of 88 knees in 44 patients who underwent simultaneous bilateral TKA', 'Registered at the University Hospital Medical Information Network (registration number', 'simultaneous bilateral total knee arthroplasty']","['percutaneous periarticular injection', 'Percutaneous periarticular analgesic injection', 'intraoperative periarticular multi-drug injection and postoperative intravenous and oral nonsteroidal anti-inflammatory drugs', 'total knee arthroplasty (TKA', 'TKA adding to intraoperative periarticular injection', 'methylprednisolone, ropivacaine, and epinephrine', 'no injection']","[""postoperative pain at rest using a visual analog scale (VAS) and analyzed with Student's t test"", 'VAS score', 'rate of complication', 'postoperative pain relief']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",88.0,0.246964,"The rate of complication did not differ between groups (p > 0.05).
","[{'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Iseki', 'Affiliation': 'Department of Orthopaedic Surgery, Nekoyama Miyao Hospital, 14-7 Konan, Chuo-ku, 950-1151, Niigata, Japan. takuyaiseki@gmail.com.'}, {'ForeName': 'Sachiyuki', 'Initials': 'S', 'LastName': 'Tsukada', 'Affiliation': 'Department of Orthopaedic Surgery, Nekoyama Miyao Hospital, 14-7 Konan, Chuo-ku, 950-1151, Niigata, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Wakui', 'Affiliation': 'Department of Orthopaedic Surgery, Nekoyama Miyao Hospital, 14-7 Konan, Chuo-ku, 950-1151, Niigata, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kurosaka', 'Affiliation': 'Department of Orthopaedic Surgery, Houksuikai Kinen Hospital, 3-2-1 Higashihara, Mito, 310-0035, Ibaraki, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Yoshiya', 'Affiliation': 'Department of Orthopaedic Surgery, Nishinomiya Kaisei Hospital, 1-4 Ohama-cho, Nishinomiya, 662-0957, Hyogo, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Tachibana', 'Affiliation': 'Department of Orthopaedic Surgery, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-021-02507-1']
1351,34077270,Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial.,"PURPOSE


The ATEMPT trial was designed to determine if treatment with trastuzumab emtansine (T-DM1) caused less toxicity than paclitaxel plus trastuzumab (TH) and yielded clinically acceptable invasive disease-free survival (iDFS) among patients with stage I human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC).
METHODS


Patients with stage I centrally confirmed HER2+ BC were randomly assigned 3:1 to T-DM1 or TH and received T-DM1 3.6 mg/kg IV every 3 weeks for 17 cycles or T 80 mg/m 2  IV with H once every week × 12 weeks (4 mg/kg load →2 mg/kg), followed by H × 39 weeks (6 mg/kg once every 3 weeks). The co-primary objectives were to compare the incidence of clinically relevant toxicities (CRTs) in patients treated with T-DM1 versus TH and to evaluate iDFS in patients receiving T-DM1.
RESULTS


The analysis population includes all 497 patients who initiated protocol therapy (383 T-DM1 and 114 TH). CRTs were experienced by 46% of patients on T-DM1 and 47% of patients on TH ( P  = .83). The 3-year iDFS for T-DM1 was 97.8% (95% CI, 96.3 to 99.3), which rejected the null hypothesis ( P  < .0001). Serially collected patient-reported outcomes indicated that patients treated with T-DM1 had less neuropathy and alopecia and better work productivity compared with patients on TH.
CONCLUSION


Among patients with stage I HER2+ BC, one year of adjuvant T-DM1 was associated with excellent 3-year iDFS, but was not associated with fewer CRT compared with TH.",2021,CRTs were experienced by 46% of patients on T-DM1 and 47% of patients on TH ( P  = .83).,"['patients with stage I human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC', '497 patients who initiated protocol therapy (383 T-DM1 and 114 TH', 'Patients with stage I centrally confirmed HER2+ BC', 'patients with stage', 'I HER2-Positive Breast Cancer']","['Adjuvant Trastuzumab Emtansine Versus Paclitaxel', 'paclitaxel plus trastuzumab (TH', 'trastuzumab emtansine (T-DM1', 'ATEMPT', 'Trastuzumab']","['3-year iDFS for T-DM1', 'incidence of clinically relevant toxicities (CRTs', 'toxicity', 'CRTs', 'neuropathy and alopecia and better work productivity', 'excellent 3-year iDFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}]",497.0,0.283611,CRTs were experienced by 46% of patients on T-DM1 and 47% of patients on TH ( P  = .83).,"[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Nabihah', 'Initials': 'N', 'LastName': 'Tayob', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Chau', 'Initials': 'C', 'LastName': 'Dang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': 'Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Isakoff', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Valero', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Faggen', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Mulvey', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Bose', 'Affiliation': 'Washington University, St Louis, MO.'}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Weckstein', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins Sidney Kimmel Cancer Center, Washington, DC.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Reeder-Hayes', 'Affiliation': 'UNC Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'UCSF, San Francisco, CA.'}, {'ForeName': 'Bhuvaneswari', 'Initials': 'B', 'LastName': 'Ramaswamy', 'Affiliation': 'OSU Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zuckerman', 'Affiliation': ""St Luke's Mountain States Tumor Institute, Boise, ID.""}, {'ForeName': 'Lowell', 'Initials': 'L', 'LastName': 'Hart', 'Affiliation': 'Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'Vijayakrishna K', 'Initials': 'VK', 'LastName': 'Gadi', 'Affiliation': 'University of Washington, Seattle, WA. Currently at University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Constantine', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'North Shore-LIJ Cancer Institute, Lake Success, NY.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Briccetti', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Schneider', 'Affiliation': 'IU School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Audrey Merrill', 'Initials': 'AM', 'LastName': 'Garrett', 'Affiliation': 'Northern Light Cancer Care, Brewer, ME.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Marcom', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Albain', 'Affiliation': 'Loyola University Medical Center, Maywood, IL.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'DeFusco', 'Affiliation': 'Hartford Healthcare Cancer Institute, Hartford, CT.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Tung', 'Affiliation': 'Harvard Medical School, Boston, MA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Ardman', 'Affiliation': 'Lowell General Hospital, Lowell, MA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Jankowitz', 'Affiliation': 'Abramsom Cancer Center, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Mothaffar', 'Initials': 'M', 'LastName': 'Rimawi', 'Affiliation': 'Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Abramson', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Pohlmann', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Van Poznak', 'Affiliation': 'Rogel Cancer Center, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'Kirklin UAB Hematology Oncology, Birmingham, AL.'}, {'ForeName': 'Minetta', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Ruddy', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Shoshana M', 'Initials': 'SM', 'LastName': 'Rosenberg', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Trippa', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barry', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'DeMeo', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Burstein', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Partridge', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Krop', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.03398']
1352,34077243,Slow-Stroke Back Massage Compared With Music Therapy for Leukemia-Related Pain and Fatigue: A Randomized Controlled Trial.,"PURPOSE


Comparison of two safe complementary medicine methods to treat cancer-related pain and fatigue in adult patients with acute leukemia during active treatment with chemotherapy.
METHODS


A randomized trial with three groups (light massage, music therapy, and standard care) in Ahvaz, Iran, between 2018 and 2019. A total of 104 participants of the massage and music therapy groups received 15-minute intervention sessions, thrice weekly for 4 weeks, and participants of the control group received standard care. Cancer-related pain and fatigue intensity were measured by numeric self-report rating scales. During the 4 weeks of the interventions, pain and fatigue intensity were measured weekly. All the groups were followed up for 2 weeks after the end of the intervention.
RESULTS


Pain and fatigue intensity decreased significantly over time between the intervention groups compared with the standard care group. In the massage and music therapy groups, a progressive reduction of pain and fatigue intensity over time (from the baseline to the fourth week) was observed. Fatigue intensity did not differ between the two intervention groups. Pain intensity decreased more in the massage group compared with the music therapy group. The durable effects of the massage therapy were greater compared with the music therapy 2 weeks after the intervention was completed.
CONCLUSION


Light massage was more effective and persisted longer than the music therapy for controlling leukemia-related pain and fatigue in adult patients with acute leukemia.",2021,"In the massage and music therapy groups, a progressive reduction of pain and fatigue intensity over time (from the baseline to the fourth week) was observed.","['adult patients with acute leukemia during active treatment with chemotherapy', 'Ahvaz, Iran, between 2018 and 2019', '104 participants of the massage and music therapy groups received', 'adult patients with acute leukemia']","['control group received standard care', 'music therapy', 'Music Therapy', 'Light massage', '15-minute intervention sessions', 'Slow-Stroke Back Massage']","['Leukemia-Related Pain and Fatigue', 'pain and fatigue intensity', 'Pain and fatigue intensity', 'Cancer-related pain and fatigue intensity', 'Fatigue intensity', 'Pain intensity', 'progressive reduction of pain and fatigue intensity over time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",104.0,0.0633123,"In the massage and music therapy groups, a progressive reduction of pain and fatigue intensity over time (from the baseline to the fourth week) was observed.","[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Miladinia', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Joachim G', 'Initials': 'JG', 'LastName': 'Voss', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Molavynejad', 'Affiliation': 'Nursing Care Research Center in Chronic Diseases, School of Nursing & Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Amal Saki', 'Initials': 'AS', 'LastName': 'Malehi', 'Affiliation': 'Nursing Care Research Center in Chronic Diseases, School of Nursing & Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Kourosh', 'Initials': 'K', 'LastName': 'Zarea', 'Affiliation': 'Nursing Care Research Center in Chronic Diseases, School of Nursing & Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Elham Mousavi', 'Initials': 'EM', 'LastName': 'Nouri', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Ahmadzadeh', 'Affiliation': 'Thalassemia and Hemoglobinopathy Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",JCO oncology practice,['10.1200/OP.21.00156']
1353,34085318,Pilot study of the effects of ventilation and ventilation noise on sleep quality in the young and elderly.,"Three conditions were established to investigate the effects of ventilation and related ventilation noise on sleep quality: No mechanical ventilation/low noise (A); Mechanical ventilation /low noise (B); Mechanical ventilation/high noise (C). The interventions were achieved by idling a mechanical ventilation system or operating it in two different modes. Nine young people and nine older people were all exposed to each of the three conditions for a whole night's sleep, but data from only 15 subjects were analyzed as three young subjects apparently slept with open windows in condition A. Sleep quality was measured objectively with polysomnography (PSG), which monitored signals of electroencephalogram (EEG), bilateral electrooculogram (EOG), and chin electromyogram (EMG) continuously during the sleeping period. Saliva samples were collected before sleep at night and after waking in the morning, and the concentrations of cortisol and lysozyme in them were determined. Without mechanical ventilation, the indoor CO 2  level averaged about 1400 ppm during the night. Operating the mechanical ventilation decreased the indoor CO 2  to below 1000 ppm, which improved objectively measured sleep quality: wake time after sleep onset (WASO) decreased on average by 15 min (p < 0.05) and sleep efficiency (SE) increased on average by about 4% (p < 0.05). Increased ventilation noise level (50.8dB(A) vs. 34.7dB(A); 54.9dB(C) vs. 48dB(C)) did not significantly change SE or WASO but did change the duration of sleep stages: It decreased the duration of deep sleep by 11min (p < 0.05) and REM sleep by 17 min (p < 0.01) and increased the duration of light sleep by 17 min (p < 0.05). The ventilation noise significantly increased the concentration of lysozyme in the elderly (p < 0.05) although no significant effects on cortisol could be shown. These results confirm that a low ventilation rate has negative effects on sleep quality and that ventilation noise at or above 50dB(A) may disrupt sleep.",2021,The ventilation noise significantly increased the concentration of lysozyme in the elderly (p < 0.05) although no significant effects on cortisol could be shown.,"['young and elderly', 'Nine young people and nine older people']","['ventilation and related ventilation noise', 'ventilation and ventilation noise', 'slept with open windows in condition A. Sleep quality was measured objectively with polysomnography (PSG', 'mechanical ventilation/low noise (A); Mechanical ventilation /low noise (B); Mechanical ventilation/high noise (C']","['duration of deep sleep', 'duration of light sleep', 'concentrations of cortisol and lysozyme', 'objectively measured sleep quality: wake time after sleep onset (WASO', 'concentration of lysozyme', 'duration of sleep stages', 'sleep efficiency (SE', 'REM sleep', 'change SE or WASO', 'Increased ventilation noise level (50.8dB(A) vs. 34.7dB(A); 54.9dB(C) vs. 48dB(C', 'sleep quality', 'monitored signals of electroencephalogram (EEG), bilateral electrooculogram (EOG), and chin electromyogram (EMG']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0278182', 'cui_str': 'Light sleep'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0026794', 'cui_str': 'Muramidase'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0013854', 'cui_str': 'Electro-oculogram examination'}, {'cui': 'C0008114', 'cui_str': 'Chin structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",9.0,0.00640344,The ventilation noise significantly increased the concentration of lysozyme in the elderly (p < 0.05) although no significant effects on cortisol could be shown.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Department of Architecture, School of Design, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yuxiang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Architecture, School of Design, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Wyon', 'Affiliation': 'Department of Civil Engineering, International Centre for Indoor Environment and Energy, Technical University of Denmark (DTU), Lyngby, Denmark.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Wargocki', 'Affiliation': 'Department of Civil Engineering, International Centre for Indoor Environment and Energy, Technical University of Denmark (DTU), Lyngby, Denmark.'}]",Indoor air,['10.1111/ina.12861']
1354,34087229,Defining mechanisms of recurrence following apical prolapse repair based on imaging criteria.,"BACKGROUND


Prolapse recurrence after transvaginal surgical repair is common; however, its mechanisms are ill-defined. A thorough understanding of how and why prolapse repairs fail is needed to address their high rate of anatomic recurrence and to develop novel therapies to overcome defined deficiencies.
OBJECTIVE


This study aimed to identify mechanisms and contributors of anatomic recurrence after vaginal hysterectomy with uterosacral ligament suspension (native tissue repair) vs transvaginal mesh (VM) hysteropexy surgery for uterovaginal prolapse.
STUDY DESIGN


This multicenter study was conducted in a subset of participants in a randomized clinical trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Overall, 94 women with uterovaginal prolapse treated via native tissue repair (n=48) or VM hysteropexy (n=46) underwent pelvic magnetic resonance imaging at rest, maximal strain, and poststrain rest (recovery) 30 to 42 months after surgery. Participants who desired reoperation before 30 to 42 months were imaged earlier to assess the impact of the index surgery. Using a novel 3-dimensional pelvic coordinate system, coregistered midsagittal images were obtained to assess study outcomes. Magnetic resonance imaging-based anatomic recurrence (failure) was defined as prolapse beyond the hymen. The primary outcome was the mechanism of failure (apical descent vs anterior vaginal wall elongation), including the frequency and site of failure. Secondary outcomes included displacement of the vaginal apex and perineal body and change in the length of the anterior wall, posterior wall, vaginal perimeter, and introitus of the vagina from rest to strain and rest to recovery. Group differences in the mechanism, frequency, and site of failure were assessed using the Fisher exact tests, and secondary outcomes were compared using Wilcoxon rank-sum tests.
RESULTS


Of the 88 participants analyzed, 37 (42%) had recurrent prolapse (VM hysteropexy, 13 of 45 [29%]; native tissue repair, 24 of 43 [56%]). The most common site of failure was the anterior compartment (VM hysteropexy, 38%; native tissue repair, 92%). The primary mechanism of recurrence was apical descent (VM hysteropexy, 85%; native tissue repair, 67%). From rest to strain, failures (vs successes) had greater inferior displacement of the vaginal apex (difference, -12 mm; 95% confidence interval, -19 to -6) and perineal body (difference, -7 mm; 95% confidence interval, -11 to -4) and elongation of the anterior vaginal wall (difference, 12 mm; 95% confidence interval, 8-16) and vaginal introitus (difference, 11 mm; 95% confidence interval, 7-15).
CONCLUSION


The primary mechanism of prolapse recurrence following vaginal hysterectomy with uterosacral ligament suspension or VM hysteropexy was apical descent. In addition, greater inferior descent of the vaginal apex and perineal body, lengthening of the anterior vaginal wall, and increased size of the vaginal introitus with strain were associated with anatomic failure. Further studies are needed to provide additional insight into the mechanism by which these factors contribute to anatomic failure.",2021,"From rest to strain, failures (vs successes) had greater inferior displacement of the vaginal apex (difference = -12 mm; 95%CI = -19 to -6) and perineal body (difference = -7 mm; 95%CI = -11 to -4), and elongation of the anterior vaginal wall (difference = 12 mm; 95%CI = 8 to 16) and vaginal introitus (difference = 11 mm; 95%CI = 7 to 15).
","['Ninety-four women with uterovaginal prolapse treated via NTR (N=48) or VM (N=46) underwent', 'subset of participants in a randomized clinical trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network']","['pelvic magnetic resonance imaging (MRI) at rest, maximal strain, and post-strain rest (recovery', 'vaginal hysterectomy with uterosacral ligament suspension or vaginal mesh hysteropexy', 'Apical Prolapse Repair', 'vaginal hysterectomy with uterosacral ligament suspension (native tissue repair [NTR]) vs (2) vaginal mesh hysteropexy (VM) surgery']","['vaginal introitus', 'recurrent prolapse', 'mechanism, frequency, and site of failure', 'mechanism of failure (apical descent vs anterior vaginal wall elongation), including the frequency and site of failure', 'prolapse recurrence', 'perineal body', 'elongation of the anterior vaginal wall', 'MRI-based anatomic recurrence (failure', 'greater inferior descent of the vaginal apex and perineal body, lengthening of the anterior vaginal wall, and increased size of the vaginal introitus with strain', 'displacement of the vaginal apex and perineal body, and change in length of the anterior wall, posterior wall, vaginal perimeter, and introitus of the vagina from (1) rest to strain and (2) rest to recovery', 'inferior displacement of the vaginal apex']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156353', 'cui_str': 'Uterovaginal prolapse'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C3178892', 'cui_str': 'Pelvic Floor Diseases'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0458952', 'cui_str': 'Vaginal introitus structure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0447612', 'cui_str': 'Vaginal wall'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0225030', 'cui_str': 'Structure of perineal body'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0227794', 'cui_str': 'Structure of fornix of vagina'}, {'cui': 'C0392744', 'cui_str': 'Lengthened'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0442070', 'cui_str': 'Anterior wall'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",94.0,0.3212,"From rest to strain, failures (vs successes) had greater inferior displacement of the vaginal apex (difference = -12 mm; 95%CI = -19 to -6) and perineal body (difference = -7 mm; 95%CI = -11 to -4), and elongation of the anterior vaginal wall (difference = 12 mm; 95%CI = 8 to 16) and vaginal introitus (difference = 11 mm; 95%CI = 7 to 15).
","[{'ForeName': 'Shaniel T', 'Initials': 'ST', 'LastName': 'Bowen', 'Affiliation': 'Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Moalli', 'Affiliation': 'Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA; Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Magee-Womens Research Institute, Pittsburgh, PA. Electronic address: moalpa@upmc.edu.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Abramowitch', 'Affiliation': 'Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Lockhart', 'Affiliation': 'Department of Radiology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Weidner', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Cecile A', 'Initials': 'CA', 'LastName': 'Ferrando', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Nager', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, UC San Diego Health, San Diego, CA.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Rardin', 'Affiliation': 'Division of Urogyneology, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Yuko M', 'Initials': 'YM', 'LastName': 'Komesu', 'Affiliation': 'University of New Mexico, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Harvie', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Amaanti', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.05.041']
1355,34112656,"Comparison of two dose escalation strategies of methotrexate in active rheumatoid arthritis: a multicentre, parallel group, randomised controlled trial.","OBJECTIVES


There are no head-to-head trials of different dose escalation strategies of methotrexate (MTX) in RA. We compared the efficacy, safety and tolerability of 'usual' (5 mg every 4 weeks) versus 'fast' (5 mg every 2 weeks) escalation of oral MTX.
METHODS


This multicentre, open-label (assessor blinded) RCT included patients 18-55 years of age having active RA with disease duration <5 years, and not on DMARDs. Patients were randomized 1:1 into usual or fast escalation groups, both groups starting MTX at 15 mg/week till a maximum of 25 mg/week. Primary outcome was EULAR good response at 16 weeks, secondary outcomes were ΔDAS28 and adverse effects (AE). Analyses were intention-to-treat.
RESULTS


178 patients with mean DAS28-CRP of 5.4(1.1) were randomized to usual (n=89) or fast escalation groups (n=89). At 16 weeks, there was no difference in good EULAR response in the usual (28.1%) or fast escalation (22.5%) groups (p=0.8). There was no difference in mean ΔDAS28-CRP at 8 weeks (-0.9, -0.8, p=0.72) or 16 weeks (-1.3, -1.3, p=0.98). Even at 24 weeks (extended follow-up), responses were similar. There were no inter-group differences in ΔHAQ, or MTX-polyglutamates 1-3 levels at 8 or 16 weeks. Gastrointestinal AE were higher in the fast escalation group over initial 8 weeks (27%, 40%, p=0.048), but not over 16 weeks. There was no difference in cytopenias, transaminitis, or drug discontinuation/dose reduction between the groups. No serious AE were seen.
CONCLUSION


A faster MTX escalation strategy in RA was not more efficacious over 16-24 weeks, and did not significantly increase AE, except higher gastrointestinal AE initially.
TRIAL REGISTRATION NUMBER


CTRI/2018/12/016549.",2021,"There were no inter-group differences in ΔHAQ, or MTX-polyglutamates 1-3 levels at 8 or 16 weeks.","['active rheumatoid arthritis', 'patients 18-55 years of age having active RA with disease duration <5 years, and not on DMARDs', '178 patients with mean DAS28-CRP of 5.4(1.1']","['RCT', 'oral MTX', 'methotrexate', 'MTX', 'methotrexate (MTX']","['ΔDAS28 and adverse effects (AE', 'mean ΔDAS28-CRP', 'good EULAR response', 'EULAR good response', 'ΔHAQ, or MTX-polyglutamates 1-3 levels', 'Gastrointestinal AE', 'efficacy, safety and tolerability', 'cytopenias, transaminitis, or drug discontinuation/dose reduction']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0066146', 'cui_str': 'methotrexate polyglutamate'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010828', 'cui_str': 'Cytopenia'}, {'cui': 'C2242708', 'cui_str': 'Hypertransaminasaemia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",178.0,0.17349,"There were no inter-group differences in ΔHAQ, or MTX-polyglutamates 1-3 levels at 8 or 16 weeks.","[{'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Dhir', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India varundhir@gmail.com.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Rheumatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Bidyalaxmi', 'Initials': 'B', 'LastName': 'Leishangthem', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Naidu', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Aastha', 'Initials': 'A', 'LastName': 'Khullar', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Maurya', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Dhawan', 'Affiliation': 'Department of Experimental Medicine and Biotechnology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Shefali Khanna', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2021-220512']
1356,34115318,"The Effects of Limosilactobacillus reuteri LR-99 Supplementation on Body Mass Index, Social Communication, Fine Motor Function, and Gut Microbiome Composition in Individuals with Prader-Willi Syndrome: a Randomized Double-Blinded Placebo-Controlled Trial.","Prader-Willi syndrome (PWS) is a rare genetic disorder associated with developmental delay, obesity, and neuropsychiatric comorbidities. Limosilactobacillus reuteri (Lactobacillus reuteri, Lact. reuteri) has demonstrated anti-obesity and anti-inflammatory effects in previous studies. In the present study, we aim to evaluate the effects of Lact. reuteri supplementation on body mass index (BMI), social behaviors, and gut microbiota in individuals with PWS. We conducted a 12-week, randomized, double-blind, placebo-controlled trial in 71 individuals with PWS aged 6 to 264 months (64.4 ± 51.0 months). Participants were randomly assigned to either receive daily Lact. reuteri LR-99 probiotic (6 × 10 10  colony forming units) or a placebo sachet. Groupwise differences were assessed for BMI, ASQ-3, and GARS-3 at baseline, 6 weeks, and 12 weeks into treatment. Gut microbiome data was analyzed with the QIIME2 software package, and predictive functional profiling was conducted with PICRUSt-2. We found a significant reduction in BMI for the probiotic group at both 6 weeks and 12 weeks relative to the baseline (P < 0.05). Furthermore, we observed a significant improvement in social communication and interaction, fine motor function, and total ASQ-3 score in the probiotics group compared to the placebo group (P < 0.05). Altered gut microbiota was observed in the probiotic group to favor weight loss and improve gut health. The findings suggest a novel therapeutic potential for Lact. reuteri LR-99 probiotic to modulate BMI, social behaviors, and gut microbiota in Prader-Willi syndrome patients, although further investigation is warranted.Trial registration Chinese Clinical Trial Registry: ChiCTR1900022646.",2021,We found a significant reduction in BMI for the probiotic group at both 6 weeks and 12 weeks relative to the baseline (P < 0.05).,"['Prader-Willi syndrome patients', 'individuals with PWS', '71 individuals with PWS aged 6 to 264\xa0months (64.4\u2009±\u200951.0\xa0months', 'Individuals with Prader-Willi Syndrome']","['Limosilactobacillus reuteri LR-99 Supplementation', 'reuteri LR-99 probiotic', 'reuteri supplementation', 'Lact', 'Placebo', 'placebo', 'daily Lact', 'placebo sachet']","['social communication and interaction, fine motor function, and total ASQ-3 score', 'BMI, ASQ-3, and GARS-3', 'body mass index (BMI), social behaviors, and gut microbiota', 'weight loss and improve gut health', 'BMI, social behaviors, and gut microbiota', 'BMI', 'Body Mass Index, Social Communication, Fine Motor Function, and Gut Microbiome Composition']","[{'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0562229', 'cui_str': 'Fine motor functions'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0327763', 'cui_str': 'Family Lepisosteidae - gar'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",71.0,0.488507,We found a significant reduction in BMI for the probiotic group at both 6 weeks and 12 weeks relative to the baseline (P < 0.05).,"[{'ForeName': 'Xue-Jun', 'Initials': 'XJ', 'LastName': 'Kong', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, USA. xkong1@mgh.harvard.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Zhuang', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ruiyi', 'Initials': 'R', 'LastName': 'Tian', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cullen', 'Initials': 'C', 'LastName': 'Clairmont', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'PWS Care and Support Center, Hangzhou, China.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Sherman', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Junli', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Yelan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Fong', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bryan K', 'Initials': 'BK', 'LastName': 'Wang', 'Affiliation': 'Brandeis University, Waltham, MA, USA.'}, {'ForeName': 'Jinghan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Zhehao', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China.'}, {'ForeName': 'Hanyu', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China.'}, {'ForeName': 'Guobin', 'Initials': 'G', 'LastName': 'Wan', 'Affiliation': 'Shenzhen Maternity and Child Healthcare Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-021-09800-9']
1357,34081322,It's all in the name: Does nomenclature for indolent prostate cancer impact management and anxiety?,"BACKGROUND


Despite consensus guidelines, many men with low-grade prostate cancer are not managed with active surveillance. Patient perception of the nomenclature used to describe low-grade prostate cancers may partly explain this discrepancy.
METHODS


A randomized online survey was administered to men without a history of prostate cancer, presenting a hypothetical clinical scenario in which they are given a new diagnosis of low-grade prostate cancer. The authors determined whether diagnosis nomenclature was associated with management preference and diagnosis-related anxiety using ratings given on a scale from 1 to 100, adjusting for participant characteristics through multivariable linear regression.
RESULTS


The survey was completed by 718 men. Compared with Gleason 6 out of 10 prostate cancer, the term grade group 1 out of 5 prostate cancer was associated with lower preference for immediate treatment versus active surveillance (β = -9.3; 95% CI, -14.4, -4.2; P < .001), lower diagnosis-related anxiety (β = -8.3; 95% CI, -12.8, -3.8; P < .001), and lower perceived disease severity (β = -12.3; 95% CI, -16.5, -8.1; P < .001) at the time of initial diagnosis. Differences decreased as participants received more disease-specific education. Indolent lesion of epithelial origin, a suggested alternative term for indolent tumors, was not associated with differences in anxiety or preference for active surveillance.
CONCLUSIONS


Within a hypothetical clinical scenario, nomenclature for low-grade prostate cancer affects initial perception of the disease and may alter subsequent decision making, including preference for active surveillance. Disease-specific education reduces the differential impact of nomenclature use, reaffirming the importance of comprehensive counseling and clear communication between the clinician and patient.",2021,"Indolent lesion of epithelial origin, a suggested alternative term for indolent tumors, was not associated with differences in anxiety or preference for active surveillance.
","['men with low-grade prostate cancer', 'men without a history of prostate cancer, presenting a hypothetical clinical scenario in which they are given a new diagnosis of low-grade prostate cancer', '718 men']",[],"['disease severity', 'lower diagnosis-related anxiety']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}]",[],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",10.0,0.0718877,"Indolent lesion of epithelial origin, a suggested alternative term for indolent tumors, was not associated with differences in anxiety or preference for active surveillance.
","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Hudnall', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Anuj S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Kyle P', 'Initials': 'KP', 'LastName': 'Tsai', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Weiner', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Amanda X', 'Initials': 'AX', 'LastName': 'Vo', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Oliver S', 'Initials': 'OS', 'LastName': 'Ko', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Schaeffer', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Shilajit D', 'Initials': 'SD', 'LastName': 'Kundu', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Cancer,['10.1002/cncr.33621']
1358,34390604,The Impact of Enriched Resistant Starch Type-2 Cookies on the Gut Microbiome in Hemodialysis Patients: A Randomized Controlled Trial.,"INTRODUCTION


Resistant starch type-2 (RS2) can mitigate inflammation and oxidative stress in hemodialysis (HD) patients. However, there is still a lack of knowledge on the impact of the RS2 on the gut microbiota community in these patients. Thus, this study aims to evaluate the effects of enriched RS2 cookies on the gut microbiome in HD patients.
METHODS AND RESULTS


This comprises a randomized, double-blind, placebo-controlled trial of age-, sex-, and BMI-matched patients and controls. The RS2 group receives enriched RS2 cookies (16 g d -1  of Hi-Maize 260, Ingredion) for 4 weeks, while the placebo group received cookies made with manioc flour. Fecal microbiota composition is evaluated by the 16S ribosomal RNA gene. Analysis of the microbiota reveals that Pielou's evenness is significantly decreased after RS2 supplementation. Notably, it is observed that RS2 intervention upregulates significantly 8 Amplicon Sequencing Variants (ASV's), including Roseburia and Ruminococcus gauvreauii, which are short-chain fatty acids (SCFA) producers. Furthermore, it is associated with the downregulation of 11 ASVs, such as the pro-inflammatory Dialister.
CONCLUSIONS


RS2 intervention for 4 weeks in HD patients effectively alters SCFA producers in the gut microbiota, suggesting that it could be a good nutritional strategy for patients with chronic kidney disease (CKD) on HD.",2021,"SCOPE


Resistant starch type-2 (RS2), can mitigate inflammation and oxidative stress in hemodialysis (HD) patients.","['hemodialysis (HD) patients', 'HD patients', 'controlled trial of age-, sex-, and BMI-matched patients and controls', 'Hemodialysis Patients', 'patients with CKD on HD']","['Enriched Resistant Starch Type-2 Cookies', 'RS2 intervention', 'SCOPE\n\n\nResistant starch type-2 (RS2', 'placebo', 'cookies made with manioc flour', 'RS2 cookies']","[""Pielou's evenness"", 'Fecal microbiota composition']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007335', 'cui_str': 'Manihot esculenta'}, {'cui': 'C0016260', 'cui_str': 'Flour'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.160275,"SCOPE


Resistant starch type-2 (RS2), can mitigate inflammation and oxidative stress in hemodialysis (HD) patients.","[{'ForeName': 'Julie Ann', 'Initials': 'JA', 'LastName': 'Kemp', 'Affiliation': 'Graduate Program in Cardiovascular Sciences, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Regis de Paiva', 'Affiliation': 'Graduate Program in Cardiovascular Sciences, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Fragoso Dos Santos', 'Affiliation': 'Department of Marine Biology, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Emiliano de Jesus', 'Affiliation': 'Department of Marine Biology, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Craven', 'Affiliation': 'Wolfson Wohl Translational Research Centre, Institute of Cancer Sciences, University of Glasgow, Bearsden, Glasgow, UK.'}, {'ForeName': 'Umer', 'Initials': 'U', 'LastName': 'Z Ijaz', 'Affiliation': 'School of Engineering University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Alvarenga Borges', 'Affiliation': 'Graduate Program in Cardiovascular Sciences, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'G Shiels', 'Affiliation': 'Wolfson Wohl Translational Research Centre, Institute of Cancer Sciences, University of Glasgow, Bearsden, Glasgow, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Mafra', 'Affiliation': 'Graduate Program in Cardiovascular Sciences, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}]",Molecular nutrition & food research,['10.1002/mnfr.202100374']
1359,34083148,Impact of a Yin Yoga and meditation intervention on pharmacy faculty and student well-being.,"BACKGROUND


Student pharmacists and faculty exhibit high levels of stress, independent of the current coronavirus 2019 pandemic, and their path toward wellness, including a reduction in stress and anxiety, is of the utmost importance. Yoga and meditation are proven interventions to reduce stress and anxiety and increase wellness. Yin yoga is an adaptable, quiet practice ideal for those lacking previous yoga experience, flexibility, and time.
OBJECTIVE


To evaluate the impact of a 6-week yin yoga and meditation intervention on College of Pharmacy faculty and students' stress perception, anxiety levels, and mindfulness skills.
METHODS


Faculty and students participated in a 6-week pilot program comprising a once-weekly yin yoga class followed by guided meditation. Yin yoga was selected for its quiet meditative style. Participants completed a pre- and postquestionnaire at 6 weeks and 3 and 6 months to evaluate potential changes in perceived stress scores, anxiety scores, and mindfulness skills. The questionnaire was composed of 3 self-reporting tools: Beck Anxiety Inventory (BAI), Perceived Stress Scale, and the Five Facet Mindfulness Questionnaire.
RESULTS


Twenty participants, 12 students and 8 faculty (ages 18-66 years), completed the study. Anxiety and stress scores decreased, and mindfulness increased at 6 weeks, 3 months and 6 months, with all changes reaching statistical significance. No participants reported being in the ""high"" category of anxiety after intervention using BAI categorical data, although this finding was not statistically significant.
CONCLUSION


Faculty and students demonstrated a reduction in stress and anxiety levels and an increase in mindfulness after a 6-week yin yoga and meditation program. Outcomes suggest that inclusion of an adaptable, meditative practice, which may easily be replicated at home, for as little as once per week for 6 weeks may reduce stress and anxiety and increase mindfulness long term. Creating a culture of wellness should be a priority for all Colleges of Pharmacy.",2021,"Anxiety and stress scores decreased, and mindfulness increased at 6 weeks, 3 months and 6 months, with all changes reaching statistical significance.","['Faculty and students participated in a 6-week pilot program comprising a', 'College of Pharmacy faculty and students', 'Twenty participants, 12 students and 8 faculty (ages 18-66 years']","['yin yoga and meditation intervention', 'once-weekly yin yoga class followed by guided meditation', 'Yin yoga', 'Yin Yoga and meditation intervention']","['stress scores, anxiety scores, and mindfulness skills', 'stress and anxiety levels', 'stress and anxiety', 'Beck Anxiety Inventory (BAI), Perceived Stress Scale, and the Five Facet Mindfulness Questionnaire', 'stress and anxiety and increase wellness', 'high"" category of anxiety', 'Anxiety and stress scores', 'stress perception, anxiety levels, and mindfulness skills']","[{'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0015539', 'cui_str': 'Pharmacy Faculty'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0197595,"Anxiety and stress scores decreased, and mindfulness increased at 6 weeks, 3 months and 6 months, with all changes reaching statistical significance.","[{'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Lemay', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hoolahan', 'Affiliation': ''}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Buchanan', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2021.05.008']
1360,34085117,A study on comparative outcomes of totally ultrasonography-guided percutaneous nephrolithotomy in prone versus flank position: a randomized clinical trial.,"PURPOSE


The percutaneous nephrolithotomy (PCNL) has become the gold-standard for treating patients with the larger renal stones and staghorn calculi. This study was designed to evaluate the outcomes of flank versus prone position in patients underwent ultrasonic-guided PCNL for treatment of large kidney stones.
METHODS


This prospective randomized clinical trial was conducted from September 2017 to September 2019 in the department of Urology, Labbafinejad University hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Two hundred patients with kidney stones larger than 2 cm underwent PCNLs in prone (n = 100) or flank position (n = 100). Success rate, operative time, access time, hemoglobin and creatinine changes, hospital stay, auxiliary procedure and surgical complications were compared between the two groups.
RESULTS


The two groups were similar in their baseline characteristics. The success rates in prone (87%) versus flank position (85%) were not significantly different at the first post-operative follow-up (p = 0.91). At the three-month follow-up, the overall stone free rates for the prone position PCNLs and flank position PCNLs were 94/100 (94%) and 90/100 (90%) (p = 0.96). There were no significant difference between the groups in operative time (p = 0.42), access time (p = 0.66), hemoglobin (p = 0.46) and creatinine (p = 0.22) changes, hospital stay (p = 0.05), auxiliary procedures (p = 0.75) and surgical complications.
CONCLUSION


Overall, there is no significant difference between prone and flank positions in success rate and complications. More prospective studies must be carried out to identify patient populations who are most apt to benefit from one position over the other.
TRIAL REGISTRATION NUMBER


IRCT20200902048597N1 DATE OF REGISTRATION: 2020-11-21, retrospectively registered.",2021,"There were no significant difference between the groups in operative time (p = 0.42), access time (p = 0.66), hemoglobin (p = 0.46) and creatinine (p = 0.22) changes, hospital stay (p = 0.05), auxiliary procedures (p = 0.75) and surgical complications.
","['September 2017 to September 2019 in the department of Urology, Labbafinejad University hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran', 'patients with the larger renal stones and staghorn calculi', 'Two hundred patients with kidney stones larger than 2 cm underwent PCNLs in prone (n\u2009=\u2009100) or flank position (n\u2009=\u2009100', 'patients underwent']","['percutaneous nephrolithotomy (PCNL', 'ultrasonic-guided PCNL', 'totally ultrasonography-guided percutaneous nephrolithotomy']","['overall stone free rates', 'success rate and complications', 'Success rate, operative time, access time, hemoglobin and creatinine changes, hospital stay, auxiliary procedure and surgical complications', 'success rates', 'operative time', 'access time', 'hemoglobin', 'hospital stay', 'surgical complications']","[{'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0333014', 'cui_str': 'Staghorn calculus'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",200.0,0.0389652,"There were no significant difference between the groups in operative time (p = 0.42), access time (p = 0.66), hemoglobin (p = 0.46) and creatinine (p = 0.22) changes, hospital stay (p = 0.05), auxiliary procedures (p = 0.75) and surgical complications.
","[{'ForeName': 'Moahmmad Hadi', 'Initials': 'MH', 'LastName': 'Radfar', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoudreza', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Urology and Nephrology Research Center, 9th Boostan, Pasdaran Avenue, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Shemshaki', 'Affiliation': 'Urology and Nephrology Research Center, 9th Boostan, Pasdaran Avenue, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sarhangnejad', 'Affiliation': 'Urology and Nephrology Research Center, 9th Boostan, Pasdaran Avenue, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Dadpour', 'Affiliation': 'Urology and Nephrology Research Center, 9th Boostan, Pasdaran Avenue, Tehran, Iran. mehdi_dadpour@yahoo.com.'}]",World journal of urology,['10.1007/s00345-021-03744-z']
1361,34088224,Laser acupuncture versus oral glucose administration for pain prevention in term neonates: an observer-blinded non-inferiority randomized controlled clinical trial.,"BACKGROUND


Neonates undergoing intensive care are routinely submitted to minor painful procedures such as heel lances. Pharmacological treatment is limited in neonatal care and not recommended for minor painful interventions. Hence, non-pharmacological acute pain management is an important subject. Acupuncture could be a new strategy for neonatal pain prevention. Accordingly, the aim of the present study was to investigate whether laser acupuncture is non-inferior to oral sweet solutions in pain prevention.
METHODS


In total, 96 healthy term neonates were randomly assigned to receive either laser acupuncture with 10 mW at LI4 bilaterally (AG, acupuncture group) or 30% oral glucose solution (GG, glucose group) before heel lance for metabolic screening. The primary outcome was the difference in premature infant pain profile (PIPP) score between groups in a non-inferiority concept. Secondary outcomes were changes in heart rate and crying time.
RESULTS


Median (interquartile range) PIPP scores were comparable in the AG and GG (12 (10-14) vs 12 (9-14), p = 0.981). Nevertheless, the 95% confidence interval (CI) of location shift exceeded the predefined margin for non-inferiority of 1 (95% CI: -1.000006 to 1.000059). Heart rate was found to be significantly lower after intervention (p = 0.048) and after heel lance (p = 0.015) in the AG versus GG. There was no difference in crying time between groups (p = 0.890).
CONCLUSION


Laser acupuncture was not shown to be non-inferior to an oral glucose solution, possibly due to the higher than expected variability in PIPP scores within the studied groups. Future neonatal laser acupuncture studies for pain prevention with higher sample sizes are therefore warranted.",2021,Heart rate was found to be significantly lower after intervention (p = 0.048) and after heel lance (p = 0.015) in the AG versus GG.,"['96 healthy term neonates', 'Neonates undergoing intensive care', 'pain prevention in term neonates']","['Laser acupuncture versus oral glucose administration', 'Laser acupuncture', 'laser acupuncture with 10\u2009mW at LI4 bilaterally (AG, acupuncture group) or 30% oral glucose solution (GG, glucose group) before heel lance for metabolic screening', 'Acupuncture', 'laser acupuncture']","['heart rate and crying time', 'crying time', 'premature infant pain profile (PIPP) score', 'PIPP scores', 'Heart rate']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0394654', 'cui_str': 'Laser acupuncture'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0450480', 'cui_str': 'LI4'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0522666', 'cui_str': 'Lance'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",96.0,0.603273,Heart rate was found to be significantly lower after intervention (p = 0.048) and after heel lance (p = 0.015) in the AG versus GG.,"[{'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Stadler', 'Affiliation': 'Division of Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Avian', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Graz, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Pichler', 'Affiliation': 'Division of Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Posch', 'Affiliation': 'Division of Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Berndt', 'Initials': 'B', 'LastName': 'Urlesberger', 'Affiliation': 'Division of Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Raith', 'Affiliation': 'Division of Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/09645284211009544']
1362,34086911,"Time Course of Metabolic, Neuroendocrine, and Adipose Effects During 2 Years of Follow-up After Gastric Bypass in Patients With Type 2 Diabetes.","CONTEXT


Roux-en-Y gastric bypass surgery (RYGB) markedly improves glycemia in patients with type 2 diabetes (T2D), but underlying mechanisms and changes over time are incompletely understood.
OBJECTIVE


Integrated assessment of neuroendocrine and metabolic changes over time in T2D patients undergoing RYGB.
DESIGN AND SETTING


Follow-up of single-center randomized study.
PATIENTS


Thirteen patients with obesity and T2D compared to 22 healthy subjects.
INTERVENTIONS


Blood chemistry, adipose biopsies, and heart rate variability were obtained before and 4, 24, and 104 weeks post-RYGB.
RESULTS


After RYGB, glucose-lowering drugs were discontinued and hemoglobin A1c fell from mean 55 to 41 mmol/mol by 104 weeks (P < 0.001). At 4 weeks, morning cortisol (P < 0.05) and adrenocorticotropin (P = 0.09) were reduced by 20%. Parasympathetic nerve activity (heart rate variability derived) increased at 4 weeks (P < 0.05) and peaked at 24 weeks (P < 0.01). C-reactive protein (CRP) and white blood cells were rapidly reduced (P < 0.01). At 104 weeks, basal and insulin-stimulated adipocyte glucose uptake increased by 3-fold vs baseline and expression of genes involved in glucose transport, fatty acid oxidation, and adipogenesis was upregulated (P < 0.01). Adipocyte volume was reduced by 4 weeks and more markedly at 104 weeks, by about 40% vs baseline (P < 0.01).
CONCLUSIONS


We propose this order of events: (1) rapid glucose lowering (days); (2) attenuated cortisol axis activity and inflammation and increased parasympathetic tone (weeks); and (3) body fat and weight loss, increased adipose glucose uptake, and whole-body insulin sensitivity (months-years; similar to healthy controls). Thus, neuroendocrine pathways can partly mediate early glycemic improvement after RYGB, and adipose factors may promote long-term insulin sensitivity and normoglycemia.",2021,Parasympathetic nerve activity (HRV-derived) increased at 4 weeks (p<0.05) and peaked at 24 weeks (p<0.01).,"['Follow-up of single-center randomized study', 'patients with type 2 diabetes (T2D', 'Thirteen patients with obesity and T2D compared to 22 healthy subjects', 'patients with T2D', 'T2D patients undergoing RYGB']",['Roux-en-Y gastric bypass surgery (RYGB'],"['Body fat and weight loss, increased adipose glucose uptake and whole-body insulin sensitivity', 'Time course of metabolic, neuroendocrine and adipose effects', 'CRP and white blood cells', 'basal and insulin-stimulated adipocyte glucose uptake', 'Adipocyte volume', 'cortisol axis activity and inflammation, increased parasympathetic tone (weeks', 'expression of genes involved in glucose transport, fatty acid oxidation and adipogenesis', 'Parasympathetic nerve activity (HRV-derived', 'morning cortisol (p<0.05) and ACTH']","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0596843', 'cui_str': 'Adipogenesis'}, {'cui': 'C0459522', 'cui_str': 'Parasympathetic nerve structure'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}]",22.0,0.0369209,Parasympathetic nerve activity (HRV-derived) increased at 4 weeks (p<0.05) and peaked at 24 weeks (p<0.01).,"[{'ForeName': 'Kristina E', 'Initials': 'KE', 'LastName': 'Almby', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Katsogiannos', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Pereira', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'F Anders', 'Initials': 'FA', 'LastName': 'Karlsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Sundbom', 'Affiliation': 'Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Wiklund', 'Affiliation': 'Department of Radiation Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Prasad G', 'Initials': 'PG', 'LastName': 'Kamble', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Eriksson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab398']
1363,34078971,Mortality and microbial diversity after allogeneic hematopoietic stem cell transplantation: secondary analysis of a randomized nutritional intervention trial.,"Gut mucosal barrier injury is common following allogeneic hematopoietic stem cell transplantation (allo-HSCT) and associated with poor clinical outcomes. Diet is critical for microbial diversity, but whether nutritional support affects microbiota and outcome after allo-HSCT is unknown. We present a secondary analysis of a randomized controlled nutritional intervention trial during allo-HSCT. We investigated if the intervention influenced gut microbiota, short-chain fatty acids (SCFAs), and markers of gut barrier functions, and if these parameters were associated with clinical outcomes. Fecal specimens were available from 47 recipients, and subjected to 16S rRNA gene sequencing. We found no significant differences between the intervention group and controls in investigated parameters. We observed a major depletion of microbiota, SCFAs, and altered markers of gut barrier function from baseline to 3 weeks post-transplant. One-year mortality was significantly higher in patients with lower diversity at 3 weeks post-HSCT, but not related to diversity at baseline. The relative abundance of Blautia genus at 3 weeks was higher in survivors. Fecal propionic acid was associated with survival. Markers of gut barrier functions were less strongly associated with clinical outcomes. Possibly, other strategies than dietary intervention are needed to prevent negative effects of gut microbiota and clinical outcomes after allo-HSCT.ClinicalTrials.gov (NCT01181076).",2021,"One-year mortality was significantly higher in patients with lower diversity at 3 weeks post-HSCT, but not related to diversity at baseline.",[],"['allogeneic hematopoietic stem cell transplantation (allo-HSCT', 'allogeneic hematopoietic stem cell transplantation']","['relative abundance of Blautia genus', 'Mortality and microbial diversity', 'Markers of gut barrier functions', 'Fecal propionic acid', 'One-year mortality', 'gut microbiota, short-chain fatty acids (SCFAs), and markers of gut barrier functions', 'major depletion of microbiota, SCFAs, and altered markers of gut barrier function']",[],"[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C2658870', 'cui_str': 'Blautia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",,0.322548,"One-year mortality was significantly higher in patients with lower diversity at 3 weeks post-HSCT, but not related to diversity at baseline.","[{'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Skaarud', 'Affiliation': 'Department of Haematology, Oslo University Hospital, P.O. Box 4950 Nydalen, 0424, Oslo, Norway. kskaarud@ous-hf.no.'}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Hov', 'Affiliation': 'Section of Gastroenterology, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Simen H', 'Initials': 'SH', 'LastName': 'Hansen', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kummen', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Valeur', 'Affiliation': 'Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ingebjørg', 'Initials': 'I', 'LastName': 'Seljeflot', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Vemund', 'Initials': 'V', 'LastName': 'Paulsen', 'Affiliation': 'Section of Gastroenterology, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Knut E A', 'Initials': 'KEA', 'LastName': 'Lundin', 'Affiliation': 'Section of Gastroenterology, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Trøseid', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Geir E', 'Initials': 'GE', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Haematology, Oslo University Hospital, P.O. Box 4950 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Per Ole', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Haematology, Oslo University Hospital, P.O. Box 4950 Nydalen, 0424, Oslo, Norway.'}]",Scientific reports,['10.1038/s41598-021-90976-z']
1364,34091420,"Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: Results from a multicentre, open-label, randomised, phase III study (COLUMBUS).","BACKGROUND


In COLUMBUS, treatment with encorafenib plus binimetinib in patients with advanced BRAF-mutant melanoma showed improved progression-free and overall survival with favourable tolerability compared to vemurafenib treatment. Here, results on health-related quality of life (HRQoL) are presented.
METHODS


COLUMBUS was a two-part, open-label, randomised, phase III study in patients with BRAF-mutant melanoma. In PART-I, 577 patients were randomised (1:1:1) to encorafenib plus binimetinib, encorafenib or vemurafenib. The primary objective was to assess progression-free survival. As a secondary objective, HRQoL was assessed by the EQ-5D, the EORTC QLQ-C30 and the FACT-M questionnaires. Furthermore, time to definitive 10% deterioration was estimated with a Kaplan-Meier analysis and differences in mean scores between groups were calculated with a mixed-effect model for repeated measures. Hospitalisation rate and the impact of hospitalisation on HRQoL were also assessed.
RESULTS


Patients receiving the combination treatment showed improvement of their FACT-M and EORTC QLQ-C30 global health status scores, compared to those receiving vemurafenib (post-baseline score differences: 3.03 [p < 0.0001] for FACT M and 5.28 [p = 0.0042] for EORTC QLQ-C30), indicative of a meaningful change in patient's status. Furthermore, a delay in the deterioration of QoL was observed in non-hospitalised patients compared to hospitalised patients (hazard ratio [95% CI]: 1.16 [0.80; 1.68] for EORTC QLQ-C30 and 1.27 [0.81; 1.99] for FACT-M) and a risk reduction of 10% deterioration, favoured the combination in both groups.
CONCLUSION


The improved efficacy of encorafenib plus binimetinib compared to vemurafenib, translates into a positive impact on the perceived health status as assessed by the HRQoL questionnaires. The study is registered with ClinicalTrials.gov, number NCT01909453 and EudraCT number 2013-001176-38.",2021,"RESULTS


Patients receiving the combination treatment showed improvement of their FACT-M and EORTC QLQ-C30 global health status scores, compared to those receiving vemurafenib (post-baseline score differences: 3.03 [p < 0.0001] for FACT M and 5.28 [p = 0.0042] for EORTC QLQ-C30), indicative of a meaningful change in patient's status.","['577 patients', 'patients with BRAF-mutant melanoma', 'patients with BRAF-mutant melanoma receiving the', 'patients with advanced BRAF-mutant melanoma']","['encorafenib plus binimetinib', 'combination encorafenib plus binimetinib', 'vemurafenib', 'encorafenib plus binimetinib, encorafenib or vemurafenib']","['Hospitalisation rate', 'deterioration of QoL', 'progression-free survival', 'Quality of life', 'improvement of their FACT-M and EORTC QLQ-C30 global health status scores', 'progression-free and overall survival', 'health-related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C4079208', 'cui_str': 'encorafenib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3899947', 'cui_str': 'Binimetinib'}, {'cui': 'C3192263', 'cui_str': 'Vemurafenib'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",577.0,0.364988,"RESULTS


Patients receiving the combination treatment showed improvement of their FACT-M and EORTC QLQ-C30 global health status scores, compared to those receiving vemurafenib (post-baseline score differences: 3.03 [p < 0.0001] for FACT M and 5.28 [p = 0.0042] for EORTC QLQ-C30), indicative of a meaningful change in patient's status.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'National and Kapodistrian University of Athens, Laikon Hospital, Athens, Greece. Electronic address: helgogas@gmail.com.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University Hospital Zürich Skin Cancer Center, Zürich, Switzerland.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Unit of Medical Oncology, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Liszkay', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Eberhard Karls University, Tuebingen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Krajsová', 'Affiliation': 'University Hospital Prague and Charles University First Medical Faculty, Prague, Czech Republic.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Vanna Chiarion', 'Initials': 'VC', 'LastName': 'Sileni', 'Affiliation': 'Oncology Institute of Veneto IRCCS, Padua, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'University Hospital Centre Bordeaux, Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'University Medical Center, Mainz, Germany.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Queirolo', 'Affiliation': 'Division of Medical Oncology for Melanoma, Sarcoma, and Rare Tumors, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Groot', 'Initials': 'G', 'LastName': 'Jan de Willem', 'Affiliation': 'Department of Medical Oncology, Isala Oncological Center, Zwolle, Netherlands.'}, {'ForeName': 'Abir Tadmouri', 'Initials': 'AT', 'LastName': 'Sellier', 'Affiliation': 'Pierre Fabre Medicament, Boulogne-Billancourt, France.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Suissa', 'Affiliation': 'Pierre Fabre Medicament, Boulogne-Billancourt, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Murris', 'Affiliation': 'Pierre Fabre Medicament, Boulogne-Billancourt, France.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Gollerkeri', 'Affiliation': 'At Time of Research: Pfizer Inc., Boulder, CO, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Institute Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.04.028']
1365,34091060,"Extracorporeal shock wave therapy for treating dyspareunia: A prospective, randomized, double-blind, placebo-controlled study.","BACKGROUND


Dyspareunia is a genital pain during or after penile-vaginal sexual intercourse. It is a painful spasm of the pelvic muscles that partly or entirely disables vaginal penetration.
OBJECTIVES


We examined the effect of extracorporeal shock wave therapy (ESWT) on idiopathic non-organic dyspareunia in women. A prospective, randomized, double-blind, placebo-controlled study was conducted.
METHODS


The study included 62 women who reported dyspareunia. Patients in the treatment and placebo groups received ESWT perineally weekly for 4 consecutive weeks; placebo patients received placebo stand-off treatment. The grade of dyspareunia was estimated by using the Marinoff Dyspareunia Scale and subjective pain intensity on a visual analog scale (VAS) before and after treatment. Follow-ups were conducted 1, 4 and 12 weeks after the final ESWT session.
RESULTS


The study included 61 women. The treatment but not placebo group differed by the Marinoff Dyspareunia Scale and VAS. Differences before and after treatment within groups were all P<0.001 and between groups, P<0.001. Pain reduction was always>30%. The effect sizes were both large: Marinoff 0.825 and VAS 0.883.
CONCLUSIONS


ESWT significantly reduced subjective pain in our women treated for dyspareunia.",2021,"Differences before and after treatment within groups were all p<0.001 and between groups, p<0.001.","['62 women who reported dyspareunia', 'idiopathic non-organic dyspareunia in women', '61 women', 'treating dyspareunia']","['extracorporeal shock wave therapy (ESWT', 'ESWT', 'Extracorporeal shock wave therapy', 'placebo stand-off treatment', 'placebo']","['subjective pain', 'grade of dyspareunia', 'Marinoff Dyspareunia Scale and VAS', 'Pain reduction', 'Marinoff Dyspareunia Scale and subjective pain intensity on a visual analog scale (VAS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0522650', 'cui_str': 'External prosthesis for sonographic procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",62.0,0.148631,"Differences before and after treatment within groups were all p<0.001 and between groups, p<0.001.","[{'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Hurt', 'Affiliation': 'Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University, Budinova 2, 18000 Prague, Czech Republic. Electronic address: hurt@prahainfo.com.'}, {'ForeName': 'Frantisek', 'Initials': 'F', 'LastName': 'Zahalka', 'Affiliation': 'Sports Motoric Laboratory, Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Halaska', 'Affiliation': 'Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University, Budinova 2, 18000 Prague, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Rakovicova', 'Affiliation': 'OBGYN Department, Amedeana, Prague, Czech Republic.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Rakovic', 'Affiliation': 'OBGYN Department, Amedeana, Prague, Czech Republic.'}, {'ForeName': 'Vaclav', 'Initials': 'V', 'LastName': 'Cmelinsky', 'Affiliation': 'OBGYN Department, Gynport, Prague, Czech Republic.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2021.101545']
1366,34096066,Correct response negativity may reflect subjective value of reaction time under regulatory fit in a speed-rewarded task.,"Error-related negativity (ERN), an electroencephalogram (EEG) component following an erroneous response, has been associated with the subjective motivational relevance of error commission. A smaller EEG event, the correct response negativity (CRN), occurs after a correct response. It is unclear why correct behavior evokes a neural response similar to error commission. CRN might reflect suboptimal performance: in tasks where speed is motivationally relevant (i.e., incentivized), a correct but slow response may be experienced as a minor error. The literature is mixed on the relationship between CRN and response time (RT), possibly due to different motivational structures, tasks, or individual traits. We examined ERN and CRN in a go/no-go task where correctness and speed were encouraged using a points-based feedback system. A key individual trait, regulatory focus, describes a person's tendency to seek gains (promotion focus) and avoid losses (prevention focus). Trait regulatory focus was measured, and participants were randomly assigned to one of three conditions: points gain, points loss, and informative-only feedback. Participants committed too few errors to reliably model ERN effects. CRN amplitude related to RT in all feedback conditions, with slower responses having larger CRN. Participants with stronger promotion focus had a more exaggerated RT/CRN relationship in the point gain condition, suggesting that regulatory fit influences the motivational relevance of speed and thus the negative subjective experience and CRN for slower responses. These findings are consistent with the claim that CRN reflects RT when RT is motivationally relevant and that the CRN/RT relationship reflects the degree of subjective motivational relevance.",2021,"CRN amplitude related to RT in all feedback conditions, with slower responses having larger CRN.",[],['CRN'],"['CRN and response time (RT', 'correct response negativity (CRN', 'exaggerated RT/CRN relationship', 'Error-related negativity (ERN), an electroencephalogram (EEG) component']",[],"[{'cui': 'C0205202', 'cui_str': 'Corrected'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0182179,"CRN amplitude related to RT in all feedback conditions, with slower responses having larger CRN.","[{'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Files', 'Affiliation': 'US Army Combat Capabilities Development Command Army Research Laboratory, Los Angeles, CA, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Pollard', 'Affiliation': 'US Army Combat Capabilities Development Command Army Research Laboratory, Los Angeles, CA, USA.'}, {'ForeName': 'Ashley H', 'Initials': 'AH', 'LastName': 'Oiknine', 'Affiliation': 'DCS Corporation, Los Angeles, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Khooshabeh', 'Affiliation': 'US Army Combat Capabilities Development Command Army Research Laboratory, Los Angeles, CA, USA.'}, {'ForeName': 'Antony D', 'Initials': 'AD', 'LastName': 'Passaro', 'Affiliation': 'US Army Combat Capabilities Development Command Army Research Laboratory, Los Angeles, CA, USA.'}]",Psychophysiology,['10.1111/psyp.13856']
1367,34092597,Dynamic fixation using rigid tape in rehabilitation after surgery of terrible triad injury of the elbow: A randomized trial.,"OBJECTIVE


The aim of the study was to identify the efficacy of dynamic fixation using rigid tape (RT) in rehabilitation after surgery of terrible triad injury of the elbow (TTIE).
METHODS


Sixty patients who underwent surgery of TTIE were equally randomly divided into RT group and hinged external fixation brace (HEFB) group. Dynamic fixations were applied for 8 weeks. General rehabilitation programs were performed for 3 months, 5 times a week. Follow-up (FU) was at six months. Main outcomes included pain (Visual Analogue Scale, VAS), muscle strength, range of motion (ROM), Elbow Function (Mayo Elbow Performance Index, MEPI), Quality of Life (QOL) (Short Form 36 Questionnaire, SF-36).
RESULTS


There were significant time x group interactions for pain, ROM, MEPI, SF-36 (all p= 0.000), which demonstrated positive efficacy of both the two interventions. Difference at each time-point (except for baseline) of pain and ROM between the two groups was statistically significant (all p< 0.05). Some differences between the two groups were not statistically significant which at 14d on MEPI (p= 0.108) and at 21d (p= 0.259) and FU (p= 0.402) on QOL. Moreover, the increased muscle strength at each time-point had no statistically significant difference between the two groups (all p> 0.05).
CONCLUSIONS


Both RT and HEFB could significantly improve the postoperative functional outcomes of the TTIE. However, early rehabilitation intervention could increase pain, which affected the corresponding function (MEPI) and QOL. Note that this kind of impact was short-term and reversible. The muscle strength and ROM were not affected by the increased severe pain, maintaining a trend of improvement. In addition, the subjects in the RT group improved faster and more efficiently and had better results with pain, ROM, MEPI, and QOL compared to the subjects in the HEFB group.",2021,"There were significant time x group interactions for pain, ROM, MEPI, SF-36 (all p= 0.000), which demonstrated positive efficacy of both the two interventions.","['rehabilitation after surgery of terrible triad injury of the elbow', 'Sixty patients who underwent surgery of TTIE']","['Dynamic fixation using rigid tape', 'dynamic fixation using rigid tape (RT', 'RT group and hinged external fixation brace (HEFB']","['pain, ROM, MEPI, SF-36', 'postoperative functional outcomes', 'corresponding function (MEPI) and QOL', 'pain, ROM, MEPI, and QOL', 'pain and ROM', 'severe pain', 'pain', 'increased muscle strength', 'muscle strength and ROM', 'QOL', 'pain (Visual Analogue Scale, VAS), muscle strength, range of motion (ROM), Elbow Function (Mayo Elbow Performance Index, MEPI), Quality of Life (QOL) (Short Form 36 Questionnaire, SF-36']","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0076994', 'cui_str': 'Triad resin'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0457406', 'cui_str': 'Hinge'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0006086', 'cui_str': 'Brace'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.0282864,"There were significant time x group interactions for pain, ROM, MEPI, SF-36 (all p= 0.000), which demonstrated positive efficacy of both the two interventions.","[{'ForeName': 'Shenxing', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': ""Department of Rehabilitation, Dongyang People's Hospital, Dongyang, Zhejiang, China.""}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Department of Orthopedics, Dongyang People's Hospital, Dongyang, Zhejiang, China.""}, {'ForeName': 'Bangjian', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Department of Orthopedic Surgery, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'Department of Rehabilitation, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Eryuan', 'Initials': 'E', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Department of Rehabilitation, Dongyang People's Hospital, Dongyang, Zhejiang, China.""}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200279']
1368,34091818,"A Comparison of 1000 Hz to 30 Hz Spinal Cord Stimulation Strategies in Patients with Unilateral Neuropathic Leg Pain Due to Failed Back Surgery Syndrome: A Multicenter, Randomized, Double-Blinded, Crossover Clinical Study (HALO).","INTRODUCTION


Multicenter, randomized, double-blinded crossover study. The Netherlands (ClinicalTrials.gov NCT02112474). We hypothesized that the pain suppressive effects of 1000 Hz and 30 Hz spinal cord stimulation (SCS) strategies are equally effective in patients with chronic, neuropathic, unilateral leg pain after back surgery.
METHODS


Thirty-two patients (18-70 years, minimum leg pain 50 mm on 100 mm visual analog scale (VAS), minimal back pain) were randomized (1:1) to start 1000 Hz or 30 Hz neurostimulation for 9 days. After a 5-day washout, they crossed over, for another 9 days. Primary outcome was pain suppression (mean of VAS scores 4×/day) during the crossover period. The main investigators were blinded to strategy allocation, patients were blinded to the outcome, a blinded assessor analyzed the primary outcome.
RESULTS


The primary outcome was analyzed in 26 patients. There was no period effect (delta 4 mm, p = 0.42, 95% CI [- 5, 13]), allowing direct intrapatient comparison of the treatment effect (delta 1 mm, p = 0.92, 95% CI [- 13, 14]). Ninety-two percent of patients in both periods experienced greater than 34% pain suppression (minimal clinically important difference, MCID). Secondary outcomes (22 patients): pain suppression and improved quality of life were sustained at 12 months; both were statistically significant and clinically relevant. Fifty percent of patients had greater than 80% pain suppression (p < 0.001). At study termination, all events were resolved; no unanticipated events were reported. Medtronic provided a grant for additional study costs.
CONCLUSION


We conclude that our hypothesis regarding the effect of 1000 Hz and 30 Hz stimulation strategies on pain suppression was confirmed. Both stimulation strategies led to a large, sustainable, clinically relevant pain suppression and improvement in quality of life.",2021,"There was no period effect (delta 4 mm, p = 0.42, 95% CI","['26 patients', 'Patients with Unilateral Neuropathic Leg Pain Due to Failed Back Surgery Syndrome', 'patients with chronic, neuropathic, unilateral leg pain after back surgery', 'Thirty-two patients (18-70\xa0years, minimum leg pain 50\xa0mm on', '1000\xa0Hz to 30']","['1000\xa0Hz and 30\xa0Hz spinal cord stimulation (SCS) strategies', 'Hz Spinal Cord Stimulation Strategies']","['100\xa0mm visual analog scale (VAS), minimal back pain', 'pain suppression (mean of VAS scores 4×/day', 'pain suppression and improved quality of life', 'quality of life', 'pain suppressive effects', 'pain suppression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0948842', 'cui_str': 'Unilateral leg pain'}, {'cui': 'C0741419', 'cui_str': 'Back surgery'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450400', 'cui_str': '50mm'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.252893,"There was no period effect (delta 4 mm, p = 0.42, 95% CI","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Breel', 'Affiliation': 'Departments of Anesthesiology, Amsterdam University Medical Centers, Location AMC, H1-156, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. j.s.breel@amsterdamumc.nl.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wille', 'Affiliation': 'Departments of Anesthesiology, Amsterdam University Medical Centers, Location AMC, H1-156, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Agnes G C L', 'Initials': 'AGCL', 'LastName': 'Wensing', 'Affiliation': 'Departments of Anesthesiology, Amsterdam University Medical Centers, Location AMC, H1-156, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan Willem', 'Initials': 'JW', 'LastName': 'Kallewaard', 'Affiliation': 'Departments of Anesthesiology, Amsterdam University Medical Centers, Location AMC, H1-156, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Harmen', 'Initials': 'H', 'LastName': 'Pelleboer', 'Affiliation': 'Departments of Anesthesiology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands.'}, {'ForeName': 'Xander', 'Initials': 'X', 'LastName': 'Zuidema', 'Affiliation': 'Departments of Anesthesiology, Amsterdam University Medical Centers, Location AMC, H1-156, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bürger', 'Affiliation': 'Departments of Anesthesiology, Alrijne Hospital, Leiderdorp, The Netherlands.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'de Graaf', 'Affiliation': 'Departments of Anesthesiology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Departments of Anesthesiology, Amsterdam University Medical Centers, Location AMC, H1-156, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}]",Pain and therapy,['10.1007/s40122-021-00268-7']
1369,34097062,"Exenatide, Dapagliflozin, or Phentermine/Topiramate Differentially Affect Metabolic Profiles in Polycystic Ovary Syndrome.","CONTEXT


Glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors reduce weight and improve insulin sensitivity via different mechanisms.
OBJECTIVE


The efficacy of once-weekly exenatide (EQW) and dapagliflozin (DAPA) alone and coadministered (EQW/DAPA), DAPA/extended-release (ER) metformin (DAPA/MET), and phentermine topiramate extended release (PHEN/TPM) on metabolic parameters, body composition, and sex hormones were examined in obese women with PCOS.
METHODS


Nondiabetic women (n = 119; aged 18-45 years) with a body mass index (BMI) greater than 30 and less than 45 and polycystic ovary syndrome (National Institutes of Health criteria) were randomly assigned in a single-blinded fashion to EQW (2 mg weekly); DAPA (10 mg daily), EQW/DAPA (2 mg weekly/10 mg daily), DAPA (10 mg)/MET (2000 mg XR daily), or PHEN (7.5 mg)/TPM (46 mg ER daily) treatment for 24 weeks. Study visits at baseline and 24 weeks included weight, blood pressure (BP), waist (WC) measures, and body composition evaluated by dual-energy x-ray absorptiometry (DXA). Oral glucose tolerance tests were conducted to assess glycemia and mean blood glucose (MBG), and compute insulin sensitivity (SI) and secretion (IS) measures. Sex steroids, free androgen index (FAI), and lipid profiles were measured in the fasting sample.
RESULTS


EQW/DAPA and PHEN/TPM resulted in the most loss of weight and total body fat by DXA, and WC. Despite equivalent reductions in BMI and WC with PHEN/TPM, only EQW/DAPA and EQW resulted in significant improvements in MBG, SI, and IS. Reductions in fasting glucose, testosterone, FAI, and BP were seen with all drugs.
CONCLUSION


Dual therapy with EQW/DAPA was superior to either alone, DAPA/MET and PHEN/TPM in terms of clinical and metabolic benefits in this patient population.",2021,"Reductions in fasting glucose, testosterone, FAI and BP were seen with all drugs.
","['Non-diabetic women (n=119; 18-45y) with BMI>30 <45 and PCOS (NIH criteria', 'polycystic ovary syndrome', 'obese women with PCOS']","['DAPA ', 'PHEN', 'EQW', 'EQW/DAPA', 'EQW/DAPA ', 'exenatide (EQW) and dapagliflozin (DAPA) alone and co-administered (EQW/DAPA), DAPA/extended release metformin (DAPA/MET', 'DAPA', 'Exenatide, dapagliflozin or phentermine/topiramate']","['Sex steroids, free androgen index (FAI) and lipid profiles', 'weight, total body fat by DXA, and WC', 'Oral glucose tolerance tests (OGTT', 'glycemia, mean blood glucose (MBG), and compute insulin sensitivity (SI) and secretion (IS) measures', 'MBG, SI and IS', 'fasting glucose, testosterone, FAI and BP', 'weight, blood pressure (BP), waist (WC) measures and body composition evaluated by dual-energy X-ray absorptiometry (DXA', 'metabolic parameters, body composition, and sex hormones', 'metabolic profiles']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C3475162', 'cui_str': 'Phentermine / topiramate'}]","[{'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",,0.0916014,"Reductions in fasting glucose, testosterone, FAI and BP were seen with all drugs.
","[{'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Elkind-Hirsch', 'Affiliation': ""Woman's Hospital Research Center, Woman's Hospital, Baton Rouge, Louisiana, USA.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Chappell', 'Affiliation': ""Fertility Answers, Woman's Hospital, Baton Rouge, Louisiana, USA.""}, {'ForeName': 'Ericka', 'Initials': 'E', 'LastName': 'Seidemann', 'Affiliation': ""Woman's Hospital Research Center, Woman's Hospital, Baton Rouge, Louisiana, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Storment', 'Affiliation': ""Fertility Answers, Woman's Hospital, Baton Rouge, Louisiana, USA.""}, {'ForeName': 'Drake', 'Initials': 'D', 'LastName': 'Bellanger', 'Affiliation': ""Woman's Weight Loss and Metabolic Clinic, Woman's Hospital, Baton Rouge, Louisiana, USA.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab408']
1370,34101004,Body weight and metabolic risk factors in patients with type 2 diabetes on a self-selected high-protein low-carbohydrate diet.,"PURPOSE


We previously reported beneficial glucoregulatory effects of a fully provided carbohydrate-reduced, high-protein (CRHP) diet in patients with type 2 diabetes mellitus (T2DM) in a crossover 2 × 6-week trial, in which patients maintained their body weight. Here, we investigated physiological changes during an additional 6-month period on a self-selected and self-prepared CRHP diet.
METHODS


Twenty-eight patients with T2DM were instructed to consume a CRHP diet (30% of energy from carbohydrate and 30% from protein) for 24 weeks, after an initial 2 × 6-week trial when all food was prepared and provided to them. Patients received dietary advice every 2 weeks. At weeks 0, 6, 12 and 36, they underwent a 3-h intravenous glucose tolerance test, a 4-h mixed meal test, and a 48-h continuous glucose monitoring. Liver, muscle, pancreas, and visceral fat contents were measured by magnetic resonance imaging.
RESULTS


During the 24-week self-selected diet period (weeks 12-36), body weight, visceral fat, liver fat, and glycated haemoglobin were maintained at the same levels achieved at the end of the fully provided diet period, and were still lower than at baseline (P < 0.05). Postprandial insulinaemia and insulin secretion were significantly greater (P < 0.05). At week 36, fasting insulin and C-peptide levels increased (P < 0.01) and daily glycaemia decreased further (P < 0.05) when compared with the end of the fully provided diet period.
CONCLUSION


Substituting dietary carbohydrate for protein and fat has metabolic benefits in patients with T2DM. These beneficial effects are maintained or augmented over the next 6 months when patients self-select and self-prepare this diet in a dietitian-supported setting.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02764021.",2021,"At week 36, fasting insulin and C-peptide levels increased (P < 0.01) and daily glycaemia decreased further (P < 0.05) when compared with the end of the fully provided diet period.
","['patients with type 2 diabetes mellitus (T2DM', 'Twenty-eight patients with T2DM', 'patients with T2DM', 'patients with type 2 diabetes on a self-selected high-protein low-carbohydrate diet']","['carbohydrate-reduced, high-protein (CRHP) diet', 'CRHP diet (30% of energy from carbohydrate and 30% from protein']","['Postprandial insulinaemia and insulin secretion', 'Body weight and metabolic risk factors', 'Liver, muscle, pancreas, and visceral fat contents', 'fasting insulin and C-peptide levels', 'body weight, visceral fat, liver fat, and glycated haemoglobin', 'daily glycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4505336', 'cui_str': 'High-Protein Low-Carbohydrate Diets'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",28.0,0.0128545,"At week 36, fasting insulin and C-peptide levels increased (P < 0.01) and daily glycaemia decreased further (P < 0.05) when compared with the end of the fully provided diet period.
","[{'ForeName': 'Ahmad H', 'Initials': 'AH', 'LastName': 'Alzahrani', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Københavns Universitet, Copenhagen, Denmark.'}, {'ForeName': 'Mads J', 'Initials': 'MJ', 'LastName': 'Skytte', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Amirsalar', 'Initials': 'A', 'LastName': 'Samkani', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Mads N', 'Initials': 'MN', 'LastName': 'Thomsen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Københavns Universitet, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Københavns Universitet, Copenhagen, Denmark.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Chabanova', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Herlev Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Frystyk', 'Affiliation': 'Department of Clinical Medicine, Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research and Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik S', 'Initials': 'HS', 'LastName': 'Thomsen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Herlev Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research and Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Steen B', 'Initials': 'SB', 'LastName': 'Haugaard', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Thure', 'Initials': 'T', 'LastName': 'Krarup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Københavns Universitet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Meinert', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Københavns Universitet, Copenhagen, Denmark.'}, {'ForeName': 'Faidon', 'Initials': 'F', 'LastName': 'Magkos', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Københavns Universitet, Copenhagen, Denmark. fma@nexs.ku.dk.'}]",European journal of nutrition,['10.1007/s00394-021-02605-0']
1371,34438060,Improved durable pulmonary vein isolation with shorter procedure times and lower energy levels using RF ablation with ablation index and a stringent lesion contiguity.,"BACKGROUND


The single procedure success rates of durable pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) varies between 80 and 90%. Ablation index, incorporating contact force, stability, time and power is a more profound parameter of significant lesion size and has been established. Equally important is a stringent contiguity of the lesion set.
METHODS AND RESULTS


A total number of 100 consecutive patients undergoing de-novo catheter ablation for paroxysmal atrial fibrillation (PAF) were analyzed between 2016 and 2019. In the first 50 patients (group A) PVI was performed using a surround flow, contact force catheter (Biosense Webster Thermocool STSF, Biosense Webster, USA) with a drag-and-ablate technique to encircle the PVs. In the following 50 patients (group B), PVI was performed using ablation index and a stringent lesion contiguity with an interlesion distance (ILD) of <5 mm. The baseline characteristics showed no significant differences between both groups. During a mean follow-up of 18 ± 3 months after a single procedure, 36 (72%) patients of group A were free of arrhythmia recurrence versus 43 (86%) patients in group B (p = 0.047). A total of 14 patients (group A: 10 (20%), group B: 4 (8%); underwent a redo-procedure. 7 patients of group A (14%) and 2 patients of group B (4%) showed recovered veins. In 3 patients of group A and 2 patients of group B the PVs were durably isolated. In these patients persistent AF recurrence was caused by extra-PV AF sources. Four patients of group A and three patients of group B had continued paroxysmal or persistent AF but did not undergo redo-procedure. With regard to the procedural data, the procedure time, the total energy and the fluoroscopy time were significantly lower in group B (AI and ILD <5 mm) (128.86 ± 18.19 versus 115.35 ± 15.38; p < 0.05; 1619.16 ± 988.56 versus 1186.26 ± 756.34; p < 0.05; 11.49 ± 3.20 versus 9.66 ± 3.86; p = 0.04). Both procedures were performed with a low number of complications, no pericardial effusion was seen in either group.
CONCLUSIONS


PVI using ablation index in combination with a stringent lesion contiguity improves clinical outcome after first-time PVI with lower PVI recovery, shorter procedure times, lower total energy and shorter fluoroscopy times and therefore, is more efficient.",2021,"With regard to the procedural data, the procedure time, the total energy and the fluoroscopy time were significantly lower in group B (AI and ILD <5 mm) (128.86 ± 18.19 versus 115.35 ± 15.38; p < 0.05; 1619.16 ± 988.56 versus 1186.26 ± 756.34; p < 0.05; 11.49 ± 3.20 versus 9.66 ± 3.86; p = 0.04).",['100 consecutive patients undergoing de-novo catheter ablation for paroxysmal atrial fibrillation (PAF) were analyzed between 2016 and 2019'],[],"['free of arrhythmia recurrence', 'AF recurrence', 'total energy and shorter fluoroscopy times', 'total energy and the fluoroscopy time', 'continued paroxysmal or persistent AF', 'pericardial effusion']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]",[],"[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0031039', 'cui_str': 'Pericardial effusion'}]",14.0,0.0270687,"With regard to the procedural data, the procedure time, the total energy and the fluoroscopy time were significantly lower in group B (AI and ILD <5 mm) (128.86 ± 18.19 versus 115.35 ± 15.38; p < 0.05; 1619.16 ± 988.56 versus 1186.26 ± 756.34; p < 0.05; 11.49 ± 3.20 versus 9.66 ± 3.86; p = 0.04).","[{'ForeName': 'Cathrin', 'Initials': 'C', 'LastName': 'Theis', 'Affiliation': 'Department of Cardiology, Robert Bosch Hospital Stuttgart, Germany. Electronic address: cathrin.theis@rbk.de.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Huber', 'Affiliation': 'Department of Cardiology, Robert Bosch Hospital Stuttgart, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Kaiser', 'Affiliation': 'Department of Cardiology, Robert Bosch Hospital Stuttgart, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kaesemann', 'Affiliation': 'Department of Cardiology, Robert Bosch Hospital Stuttgart, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hui', 'Affiliation': 'Department of Cardiology, Robert Bosch Hospital Stuttgart, Germany.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Pirozzolo', 'Affiliation': 'Department of Cardiology, Robert Bosch Hospital Stuttgart, Germany.'}, {'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Bekeredjian', 'Affiliation': 'Department of Cardiology, Robert Bosch Hospital Stuttgart, Germany.'}]",Indian pacing and electrophysiology journal,['10.1016/j.ipej.2021.08.005']
1372,34436928,"Veliparib in Combination With Platinum-Based Chemotherapy for First-Line Treatment of Advanced Squamous Cell Lung Cancer: A Randomized, Multicenter Phase III Study.","PURPOSE


Squamous non-small-cell lung cancer (sqNSCLC) is genetically complex with evidence of DNA damage. This phase III study investigated the efficacy and safety of poly (ADP-ribose) polymerase inhibitor veliparib in combination with conventional chemotherapy for advanced sqNSCLC (NCT02106546).
PATIENTS AND METHODS


Patients age ≥ 18 years with untreated, advanced sqNSCLC were randomly assigned 1:1 to carboplatin and paclitaxel with veliparib 120 mg twice daily (twice a day) or placebo twice a day for up to six cycles. The primary end point was overall survival (OS) in the veliparib arm versus the control arm in current smokers, based on phase II findings. Archival tumor samples were provided for biomarker analysis using a 52-gene expression histology classifier (LP52).
RESULTS


Overall, 970 patients were randomly assigned to carboplatin and paclitaxel plus either veliparib (n = 486) or placebo (n = 484); 57% were current smokers. There was no significant OS benefit with veliparib in current smokers, with median OS 11.9 versus 11.1 months (hazard ratio [HR], 0.905; 95% CI, 0.744 to 1.101;  P  = .266). In the overall population, OS favored veliparib; median OS was 12.2 versus 11.2 months (HR, 0.853; 95% CI, 0.747 to 0.974), with no difference in progression-free survival (median 5.6 months per arm). In patients with biomarker-evaluable tumor samples (n = 360), OS favored veliparib in the LP52-positive population (median 14.0  v  9.6 months; HR, 0.66; 95% CI, 0.49 to 0.89), but favored placebo in the LP52-negative population (median 11.0  v  14.4 months; HR, 1.33; 95% CI, 0.95 to 1.86). No new safety signals were observed in the experimental arm.
CONCLUSION


In current smokers with advanced sqNSCLC, there was no therapeutic benefit of adding veliparib to first-line chemotherapy. The LP52 signature may identify a subgroup of patients likely to derive benefit from veliparib with chemotherapy.",2021,"In the overall population, OS favored veliparib; median OS was 12.2 versus 11.2 months (HR, 0.853; 95% CI, 0.747 to 0.974), with no difference in progression-free survival (median 5.6 months per arm).","['Advanced Squamous Cell Lung Cancer', '970 patients', 'Squamous non-small-cell lung cancer (sqNSCLC', 'Patients age ≥ 18 years with untreated, advanced sqNSCLC']","['carboplatin and paclitaxel with veliparib 120 mg twice daily (twice a day) or placebo', 'carboplatin and paclitaxel plus either veliparib', 'poly (ADP-ribose) polymerase inhibitor veliparib', 'placebo', 'Veliparib in Combination With Platinum-Based Chemotherapy']","['new safety signals', 'efficacy and safety', 'overall survival (OS', 'progression-free survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0149782', 'cui_str': 'Squamous cell carcinoma of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",970.0,0.335613,"In the overall population, OS favored veliparib; median OS was 12.2 versus 11.2 months (HR, 0.853; 95% CI, 0.747 to 0.974), with no difference in progression-free survival (median 5.6 months per arm).","[{'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, University of Turin, AOU San Luigi Gonzaga, Orbassano, Torino, Italy.'}, {'ForeName': 'Salih Zeki', 'Initials': 'SZ', 'LastName': 'Guclu', 'Affiliation': 'Chest Diseases Clinic, Izmir Chest Diseases Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Bentsion', 'Affiliation': 'Sverdlovsk Regional Oncology Center, Yekaterinburg, Russia.'}, {'ForeName': 'Zanete', 'Initials': 'Z', 'LastName': 'Zvirbule', 'Affiliation': 'Riga Eastern Clinical University Hospital, Latvian Oncology Center, Riga, Latvia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Szilasi', 'Affiliation': 'Department for Pulmonology, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Reyes', 'Initials': 'R', 'LastName': 'Bernabe', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Seville, Spain.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Syrigos', 'Affiliation': '3rd Department of Medicine, National & Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Lauren Averett', 'Initials': 'LA', 'LastName': 'Byers', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clingan', 'Affiliation': 'Southern Medical Day Care Centre, Wollongong, NSW, Australia.'}, {'ForeName': 'Jair', 'Initials': 'J', 'LastName': 'Bar', 'Affiliation': 'Institute of Oncology, Sheba Medical Center, Tel HaShomer, Ramat Gan, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Everett E', 'Initials': 'EE', 'LastName': 'Vokes', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Ramaswamy', 'Initials': 'R', 'LastName': 'Govindan', 'Affiliation': 'Washington University, St Louis, MO.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dunbar', 'Affiliation': 'AbbVie Inc, North Chicago, IL.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ansell', 'Affiliation': 'AbbVie Inc, North Chicago, IL.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'AbbVie Inc, North Chicago, IL.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'AbbVie Inc, North Chicago, IL.'}, {'ForeName': 'Vasudha', 'Initials': 'V', 'LastName': 'Sehgal', 'Affiliation': 'AbbVie Inc, North Chicago, IL.'}, {'ForeName': 'Jaimee', 'Initials': 'J', 'LastName': 'Glasgow', 'Affiliation': 'AbbVie Inc, North Chicago, IL.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Bach', 'Affiliation': 'AbbVie Inc, North Chicago, IL.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Toulouse University Hospital, Institut Universitaire du Cancer, Université Paul Sabatier, Toulouse, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.03318']
1373,34088883,Variability in Submaximal Self-Paced Exercise Bouts of Different Intensity and Duration.,"PURPOSE


Rating of perceived exertion (RPE) as a training-intensity prescription has been extensively used by athletes and coaches. However, individual variability in the physiological response to exercise prescribed using RPE has not been investigated.
METHODS


Twenty well-trained competitive cyclists (male = 18, female = 2, maximum oxygen consumption =55.07 [11.06] mL·kg-1·min-1) completed 3 exercise trials each consisting of 9 randomized self-paced exercise bouts of either 1, 4, or 8 minutes at RPEs of 9, 13, and 17. Within-athlete variability (WAV) and between-athletes variability (BAV) in power and physiological responses were calculated using the coefficient of variation. Total variability was calculated as the ratio of WAV to BAV.
RESULTS


Increased RPEs were associated with higher power, heart rate, work, volume of expired oxygen (VO2), volume of expired carbon dioxide (VCO2), minute ventilation (VE), deoxyhemoglobin (ΔHHb) (P < .001), and lower tissue saturation index (ΔTSI%) and ΔO2Hb (oxyhaemoglobin; P < .001). At an RPE of 9, shorter durations resulted in lower VO2 (P < .05) and decreased ΔTSI%, and the ΔHHb increased as the duration increased (P < .05). At an RPE of 13, shorter durations resulted in lower VO2, VE, and percentage of maximum oxygen consumption (P < .001), as well as higher power, heart rate, ΔHHb (P < .001), and ΔTSI% (P < .05). At an RPE of 17, power (P < .001) and ΔTSI% (P < .05) increased as duration decreased. As intensity and duration increased, WAV and BAV in power, work, heart rate, VO2, VCO2, and VE decreased, and WAV and BAV in near-infrared spectroscopy increased.
CONCLUSIONS


Self-paced intensity prescriptions of high effort and long duration result in the greatest consistency on both a within- and between-athletes basis.",2021,"At an RPE of 9, shorter durations resulted in lower VO2 (P < .05) and decreased ΔTSI%, and the ΔHHb increased as the duration increased (P < .05).","['Twenty well-trained competitive cyclists (male = 18, female = 2, maximum oxygen consumption =55.07']","['ΔTSI', 'perceived exertion (RPE']","['heart rate, work, volume of expired oxygen (VO2), volume of expired carbon dioxide\xa0(VCO2), minute ventilation\xa0(VE), deoxyhemoglobin (ΔHHb', 'intensity and duration increased, WAV and BAV in power, work, heart rate, VO2, VCO2, and VE decreased, and WAV and BAV', 'lower tissue saturation index (ΔTSI%) and ΔO2Hb (oxyhaemoglobin', 'higher power, heart rate, ΔHHb', 'Total variability', 'ΔTSI', 'lower VO2, VE, and percentage of maximum oxygen consumption', 'lower VO2']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0057437', 'cui_str': 'Deoxyhemoglobin'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",20.0,0.020011,"At an RPE of 9, shorter durations resulted in lower VO2 (P < .05) and decreased ΔTSI%, and the ΔHHb increased as the duration increased (P < .05).","[{'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': ""O'Grady"", 'Affiliation': ''}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Passfield', 'Affiliation': ''}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Hopker', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0785']
1374,34088701,"Effect of Recombinant Human Parathyroid Hormone (1-84) on Resolution of Active Charcot Neuro-osteoarthropathy in Diabetes: A Randomized, Double-Blind, Placebo-Controlled Study.","OBJECTIVE


Fractures in Charcot neuro-osteoarthropathy (CN) often fail to heal despite prolonged immobilization with below-knee casting. The aim of the study was to assess the efficacy of recombinant human parathyroid hormone (PTH) in reducing time to resolution of CN and healing of fractures.
RESEARCH DESIGN AND METHODS


People with diabetes and acute (active) Charcot foot were randomized (double-blind) to either full-length PTH (1-84) or placebo therapy, both in addition to below-knee casting and calcium and vitamin D3 supplementation. The primary outcome was resolution of CN, defined as a skin foot temperature difference >2°C at two consecutive monthly visits.
RESULTS


Median time to resolution was 5 months (95% CI 4, 12) in intervention and 6 months (95% CI 2, 9) in control. On univariate mixed Cox and logistic regression, there was no significant difference in time to resolution between the groups ( P  = 0.64) or in the likelihood of resolution ( P  = 0.66). The hazard ratio of resolution was 0.84 (95% CI 0.41, 1.74;  P  = 0.64), and the odds ratio of resolution by 12 months was 0.80 (95% CI 0.3, 2.13;  P  = 0.66) (intervention vs. control). On linear regression analysis, there were no significant differences in the effect of treatment on fracture scores quantitated on MRI scans (coefficient 0.13 [95% CI -0.62, 0.88];  P  = 0.73) and on foot and ankle X-rays (coefficient 0.30 [95% CI -0.03, 0.63];  P  = 0.07).
CONCLUSIONS


This double-blind placebo-controlled trial did not reduce time to resolution or enhance fracture healing of CN. There was no added benefit of daily intervention with PTH (1-84) to below-knee casting in achieving earlier resolution of CN.",2021,"On linear regression analysis, there were no significant differences in the effect of treatment on fracture scores quantitated on MRI scans (coefficient 0.13","['People with diabetes and acute (active', 'Diabetes']","['full-length PTH (1-84) or placebo therapy, both in addition to below-knee casting and calcium and vitamin D3 supplementation', 'Recombinant Human Parathyroid Hormone', 'Placebo', 'recombinant human parathyroid hormone (PTH', 'placebo']","['resolution of CN, defined as a skin foot temperature difference >2°C', 'odds ratio of resolution', 'Median time to resolution', 'hazard ratio of resolution', 'time to resolution or enhance fracture healing of CN', 'time to resolution', 'fracture scores quantitated on MRI scans']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]","[{'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0263661', 'cui_str': 'Disorder of skeletal system'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",,0.6896,"On linear regression analysis, there were no significant differences in the effect of treatment on fracture scores quantitated on MRI scans (coefficient 0.13","[{'ForeName': 'Nina L', 'Initials': 'NL', 'LastName': 'Petrova', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, U.K nina.petrova@nhs.net.""}, {'ForeName': 'Nicholas K', 'Initials': 'NK', 'LastName': 'Donaldson', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, U.K.""}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Bates', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, U.K.""}, {'ForeName': 'Wegin', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, U.K.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Jemmott', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, U.K.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Morris', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, U.K.""}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Dew', 'Affiliation': ""Department of Clinical Biochemistry, King's College Hospital NHS Foundation Trust, London, U.K.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Meacock', 'Affiliation': ""Department of Radiology, King's College Hospital NHS Foundation Trust, London, U.K.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Elias', 'Affiliation': ""Department of Radiology, King's College Hospital NHS Foundation Trust, London, U.K.""}, {'ForeName': 'Cajetan F', 'Initials': 'CF', 'LastName': 'Moniz', 'Affiliation': ""Department of Clinical Biochemistry, King's College Hospital NHS Foundation Trust, London, U.K.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Edmonds', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, U.K.""}]",Diabetes care,['10.2337/dc21-0008']
1375,34086751,Effectiveness of attentional bias modification training as add-on to regular treatment in alcohol and cannabis use disorder: A multicenter randomized control trial.,"BACKGROUND


Attentional bias for substance-relevant cues has been found to contribute to the persistence of addiction. Attentional bias modification (ABM) interventions might, therefore, increase positive treatment outcome and reduce relapse rates. The current study investigated the effectiveness of a newly developed home-delivered, multi-session, internet-based ABM intervention, the Bouncing Image Training Task (BITT), as an add-on to treatment as usual (TAU).
METHODS


Participants (N = 169), diagnosed with alcohol or cannabis use disorder, were randomly assigned to one of two conditions: the experimental ABM group (50%; TAU+ABM); or the control group (50%; split in two subgroups the TAU+placebo group and TAU-only group, 25% each). Participants completed baseline, post-test, and 6 and 12 months follow-up measures of substance use and craving allowing to assess long-term treatment success and relapse rates. In addition, attentional bias (both engagement and disengagement), as well as secondary physical and psychological complaints (depression, anxiety, and stress) were assessed.
RESULTS


No significant differences were found between conditions with regard to substance use, craving, relapse rates, attentional bias, or physical and psychological complaints.
CONCLUSIONS


The findings may reflect unsuccessful modification of attentional bias, the BITT not targeting the relevant process (engagement vs. disengagement bias), or may relate to the diverse treatment goals of the current sample (i.e., moderation or abstinence). The current findings provide no support for the efficacy of this ABM approach as an add-on to TAU in alcohol or cannabis use disorder. Future studies need to delineate the role of engagement and disengagement bias in the persistence of addiction, and the role of treatment goal in the effectiveness of ABM interventions.",2021,"No significant differences were found between conditions with regard to substance use, craving, relapse rates, attentional bias, or physical and psychological complaints.
","['alcohol and cannabis use disorder', 'Participants (N = 169), diagnosed with alcohol or cannabis use disorder']","['attentional bias modification training', 'Attentional bias modification (ABM) interventions', 'TAU+placebo group and TAU', 'newly developed home-delivered, multi-session, internet-based ABM intervention, the Bouncing Image Training Task (BITT']","['substance use, craving, relapse rates, attentional bias, or physical and psychological complaints', 'relapse rates', 'substance use and craving allowing to assess long-term treatment success and relapse rates', 'secondary physical and psychological complaints (depression, anxiety, and stress']","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",169.0,0.0912504,"No significant differences were found between conditions with regard to substance use, craving, relapse rates, attentional bias, or physical and psychological complaints.
","[{'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Heitmann', 'Affiliation': 'Verslavingszorg Noord Nederland, Groningen, The Netherlands.'}, {'ForeName': 'Madelon E', 'Initials': 'ME', 'LastName': 'van Hemel-Ruiter', 'Affiliation': 'Bureau Gedragsstrategie, Assen, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Huisman', 'Affiliation': 'Department of Sociology/ICS, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Ostafin', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Addiction Development and Psychopathology (ADAPT)-LAB, Department of Psychology, and Centre for Urban Mental Health, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'MacLeod', 'Affiliation': 'School of Psychological Science, The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'DeFuentes-Merillas', 'Affiliation': 'Novadic-Kentron, Network for Addiction Treatment Services, Vught, The Netherlands.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Fledderus', 'Affiliation': 'Stichting Philadelphia Zorg, Amersfoort, The Netherlands.'}, {'ForeName': 'Wiebren', 'Initials': 'W', 'LastName': 'Markus', 'Affiliation': 'Iriszorg, Arnhem, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0252494']
1376,34086740,Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol.,"The occurrence of adverse events frequently accompanies tumor treatments. Side effects should be detected and treated as soon as possible to maintain the best possible treatment outcome. Besides the standard reporting system Common Terminology Criteria for Adverse Events (CTCAE), physicians have recognized the potential of patient-reporting systems. These are based on a more subjective description of current patient reporting symptoms. Patient-reported symptoms are essential to define the impact of a given treatment on the quality of life and the patient's wellbeing. They also act against an underreporting of side effects which are paramount to define the actual value of a treatment for the individual patient. Here, we present a study protocol for a clinical trial that assesses the potential of a smartphone application for CTCAE conform symptom reporting and tracking that is adjusted to the standard clinical reporting system rather than symptom oriented descriptive trial tools. The presented study will be implemented in two parts, both lasting over six months. The first part will assess the feasibility of the application with 30 patients non-randomly divided into three equally-sized age groups (<55years, 55-75years, >75years). In the second part 36 other patients will be randomly assigned to two groups, one reporting using the smartphone and one not. This prospective second part will compare the impact of smartphone reported adverse events regarding applied therapy doses and quality of life to those of patients receiving standard care. We aim for early detection and treatment of adverse events in oncological treatment to improve patients' safety and outcomes. For this purpose, we will capture frequent adverse events of chemotherapies, immunotherapies, or other targeted therapies with our smartphone application. The presented trial is registered at the U.S. National Library of Medicine ClinicalTrials.gov (NCT04493450) on July 30, 2020.",2021,"The first part will assess the feasibility of the application with 30 patients non-randomly divided into three equally-sized age groups (<55years, 55-75years, >75years).","['30 patients non-randomly divided into three equally-sized age groups (<55years, 55-75years, >75years', 'patients receiving standard care']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],[],,0.0531703,"The first part will assess the feasibility of the application with 30 patients non-randomly divided into three equally-sized age groups (<55years, 55-75years, >75years).","[{'ForeName': 'Angelika M R', 'Initials': 'AMR', 'LastName': 'Kestler', 'Affiliation': 'Department of Internal Medicine I, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Silke D', 'Initials': 'SD', 'LastName': 'Kühlwein', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Johann M', 'Initials': 'JM', 'LastName': 'Kraus', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Julian D', 'Initials': 'JD', 'LastName': 'Schwab', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Szekely', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Thiam', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Hühne', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jahn', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Fürstberger', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Nensi', 'Initials': 'N', 'LastName': 'Ikonomi', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Balig', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Schuler', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kuhn', 'Affiliation': 'Comprehensive Cancer Center, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Steger', 'Affiliation': 'Institute of the History, Philosophy and Ethics of Medicine, Ulm University, Ulm, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Department of Internal Medicine I, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Kestler', 'Affiliation': 'Institute of Medical Systems Biology, Ulm University, Ulm, Germany.'}]",PloS one,['10.1371/journal.pone.0252493']
1377,34062484,"Randomised phase 2 study comparing the efficacy and safety of the oral tyrosine kinase inhibitor nintedanib with single agent ifosfamide in patients with advanced, inoperable, metastatic soft tissue sarcoma after failure of first-line chemotherapy: EORTC-1506-STBSG ""ANITA"".","PURPOSE


EORTC-1506-STBSG was a prospective, multicentric, randomised, open-label phase 2 trial to assess the efficacy and safety of second-line nintedanib versus ifosfamide in patients with advanced, inoperable metastatic soft tissue sarcoma (STS). The primary end-point was progression-free survival.
PATIENTS/METHODS


Patients with a variety of STS subtypes were randomised 1:1 to nintedanib (200 mg b.i.d. p.o. until disease progression) or ifosfamide (3 g/m 2  i.v. days 1-3, every 21 days for ≤6 cycles). A Korn design was applied aiming to detect an improvement in median progression-free survival (mPFS) from 3 to 4.5 months (HR = 0.667). An interim look was incorporated to stop the trial for futility if <19 of the first 36 patients treated with nintedanib were progression-free at week 12.
RESULTS


At the interim analysis, among the first 36 eligible and evaluable patients randomised for nintedanib, only 13 (36%) were progression-free at week 12. The trial was closed for further accrual as per protocol. In total, 80 patients were randomised (40 per treatment group). The mPFS was 2.5 months (95% CI: 1.5-3.4) for nintedanib and 4.4 months (95% CI: 2.9-6.7) on ifosfamide (adjusted HR = 1.56 [80% CI: 1.14-2.13], p = 0.070). The median overall survival was 13.7 months (95% CI: 9.4-23.4) on nintedanib and 24.1 months (95% CI: 10.9-NE) on ifosfamide (adjusted HR = 1.65 [95%CI:0.89-3.06], p = 0.111). The clinical benefit rate for nintedanib and ifosfamide was 50% versus 62.5% (p = 0.368), respectively. Common treatment-related adverse events (all grades) were diarrhoea (35.9% of patients), fatigue (25.6%) and nausea (20.5%) for nintedanib; and fatigue (52.6%), nausea (44.7%) and vomiting, anorexia and alopecia (28.9% each) for ifosfamide.
CONCLUSION


The trial was stopped for futility. The activity of nintedanib did not warrant further exploration in non-selected, advanced STSs.",2021,The mPFS was 2.5 months (95% CI: 1.5-3.4) for nintedanib and 4.4 months,"['patients with advanced, inoperable metastatic soft tissue sarcoma (STS', 'Patients with a variety of STS subtypes', 'patients with advanced, inoperable, metastatic soft tissue sarcoma after failure of first-line chemotherapy']","['nintedanib and ifosfamide', 'oral tyrosine kinase inhibitor nintedanib with single agent ifosfamide', 'second-line nintedanib versus ifosfamide', 'ifosfamide', 'nintedanib']","['efficacy and safety', 'progression-free survival', 'vomiting, anorexia\xa0and alopecia', 'nausea', 'adverse events', 'diarrhoea', 'median overall survival', 'fatigue', 'median progression-free survival (mPFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",80.0,0.345269,The mPFS was 2.5 months (95% CI: 1.5-3.4) for nintedanib and 4.4 months,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium; Department of Oncology, KU Leuven, Laboratory of Experimental Oncology, Leuven, Belgium. Electronic address: patrick.schoffski@uzleuven.be.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Toulmonde', 'Affiliation': 'Sarcoma Unit, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Estival', 'Affiliation': 'Department of Medical Oncology, Catalan Institute of Oncology (ICO) Badalona / Hospital Germans Trias I Pujol. B-ARGO, Barcelona, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Marquina', 'Affiliation': 'Department of General Medical Oncology, Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Dudzisz-Śledź', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Brahmi', 'Affiliation': 'Centre Léon Bérard, Université Cl. Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Neeltje', 'Initials': 'N', 'LastName': 'Steeghs', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Karavasilis', 'Affiliation': 'University College Hospital, London, United Kingdom.'}, {'ForeName': 'Jacco', 'Initials': 'J', 'LastName': 'de Haan', 'Affiliation': 'University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Wozniak', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium; Department of Oncology, KU Leuven, Laboratory of Experimental Oncology, Leuven, Belgium.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Cousin', 'Affiliation': 'Sarcoma Unit, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Domènech', 'Affiliation': 'Department of Medical Oncology, Catalan Institute of Oncology (ICO) Badalona / Hospital Germans Trias I Pujol. B-ARGO, Barcelona, Spain.'}, {'ForeName': 'Judith V M G', 'Initials': 'JVMG', 'LastName': 'Bovée', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Charon-Barra', 'Affiliation': 'Department of Pathology, Centre Georges-François Leclerc, Dijon, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Litière', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Meulemeester', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Olungu', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.04.015']
1378,34092112,Randomized Phase III Postoperative Trial of Platinum-Based Chemotherapy Versus Capecitabine in Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy: ECOG-ACRIN EA1131.,"PURPOSE


Patients with triple-negative breast cancer (TNBC) and residual invasive disease (RD) after completion of neoadjuvant chemotherapy (NAC) have a high-risk for recurrence, which is reduced by adjuvant capecitabine. Preclinical models support the use of platinum agents in the TNBC basal subtype. The EA1131 trial hypothesized that invasive disease-free survival (iDFS) would not be inferior but improved in patients with basal subtype TNBC treated with adjuvant platinum compared with capecitabine.
PATIENTS AND METHODS


Patients with clinical stage II or III TNBC with ≥ 1 cm RD in the breast post-NAC were randomly assigned to receive platinum (carboplatin or cisplatin) once every 3 weeks for four cycles or capecitabine 14 out of 21 days every 3 weeks for six cycles. TNBC subtype (basal  v  nonbasal) was determined by PAM50 in the residual disease. A noninferiority design with superiority alternative was chosen, assuming a 4-year iDFS of 67% with capecitabine.
RESULTS


Four hundred ten of planned 775 participants were randomly assigned to platinum or capecitabine between 2015 and 2021. After median follow-up of 20 months and 120 iDFS events (61% of full information) in the 308 (78%) patients with basal subtype TNBC, the 3-year iDFS for platinum was 42% (95% CI, 30 to 53) versus 49% (95% CI, 39 to 59) for capecitabine. Grade 3 and 4 toxicities were more common with platinum agents. The Data and Safety Monitoring Committee recommended stopping the trial as it was unlikely that further follow-up would show noninferiority or superiority of platinum.
CONCLUSION


Platinum agents do not improve outcomes in patients with basal subtype TNBC RD post-NAC and are associated with more severe toxicity when compared with capecitabine. Participants had a lower than expected 3-year iDFS regardless of study treatment, highlighting the need for better therapies in this high-risk population.",2021,"Participants had a lower than expected 3-year iDFS regardless of study treatment, highlighting the need for better therapies in this high-risk population.","['Four hundred ten of planned 775 participants', 'Patients with clinical stage II or III TNBC with ≥ 1 cm RD in the breast post-NAC', 'Patients with triple-negative breast cancer (TNBC) and residual invasive disease (RD) after completion of', 'patients with basal subtype TNBC treated with', 'Patients With Residual Triple-Negative Breast Cancer']","['capecitabine', 'neoadjuvant chemotherapy (NAC', 'adjuvant platinum', 'platinum (carboplatin or cisplatin', 'Platinum-Based Chemotherapy Versus Capecitabine', 'platinum or capecitabine']","['Grade 3 and 4 toxicities', 'invasive disease-free survival (iDFS', 'severe toxicity', '3-year iDFS for platinum']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4517874', 'cui_str': '775'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205571', 'cui_str': 'Clinical stage II'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]",775.0,0.2163,"Participants had a lower than expected 3-year iDFS regardless of study treatment, highlighting the need for better therapies in this high-risk population.","[{'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Fengmin', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Dana-Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Arteaga', 'Affiliation': 'UT Southwestern Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Symmans', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Ben H', 'Initials': 'BH', 'LastName': 'Park', 'Affiliation': 'Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Burnette', 'Affiliation': 'Cancer Research of Wisconsin and Northern Michigan (CROWN) NCORP, Green Bay, WI.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, WI.'}, {'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Garcia', 'Affiliation': 'Northwestern University, Evanston, IL.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Smith', 'Affiliation': 'Johns Hopkins University, Sidney Kimmel Cancer Center, Baltimore, MD.'}, {'ForeName': 'Della F', 'Initials': 'DF', 'LastName': 'Makower', 'Affiliation': 'Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Block', 'Affiliation': 'Alegent Health Bergan Mercy Medical Center, Omaha, NE.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Morley', 'Affiliation': 'Saint Joseph Mercy Hospital, Ann Arbor, MI.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Jani', 'Affiliation': 'Phoebe Putney Memorial Hospital, Albany, GA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Mescher', 'Affiliation': 'Metro-Minnesota Community Oncology Research Consortium, St Louis Park, MN.'}, {'ForeName': 'Shabana J', 'Initials': 'SJ', 'LastName': 'Dewani', 'Affiliation': 'Columbus Oncology and Hematology Associates Inc, Columbus, OH.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Tawfik', 'Affiliation': 'University of New Mexico Cancer Center, Albuquerque, NM.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Flaum', 'Affiliation': 'Northwestern University, Evanston, IL.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Mayer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Sikov', 'Affiliation': 'Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Eve T', 'Initials': 'ET', 'LastName': 'Rodler', 'Affiliation': 'University of California, Davis, Davis, CA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston-Salem, NC.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'DeMichele', 'Affiliation': 'University of Pennsylvania/Abramson Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins University, Sidney Kimmel Cancer Center, Baltimore, MD.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.00976']
1379,34098030,Randomized Trial of Radiation Therapy With Weekly Cisplatin or Cetuximab in Low-Risk HPV-Associated Oropharyngeal Cancer (TROG 12.01) - A Trans-Tasman Radiation Oncology Group Study.,"PURPOSE


The excellent prognosis of patients with low-risk human papillomavirus (HPV)- associated oropharyngeal squamous cell carcinoma has led to concerns about overtreatment and excessive toxicity with radiation therapy and cisplatin, leading to interest in de-intensification trials. We investigated whether cetuximab, an epidermal growth factor receptor targeting antibody, when combined with radiation therapy would result in a decrease in symptom burden and toxicity with similar efficacy compared with weekly cisplatin.
METHODS AND MATERIALS


TROG12.01, a randomized, multicenter trial involving 15 sites in Australia and New Zealand enrolled patients with HPV-associated oropharyngeal squamous cell carcinoma, American Joint Committee on Cancer 7th edition stage III (excluding T1-2N1) or stage IV (excluding T4 and/or N3 and/or N2b-c if smoking history >10 pack years and/or distant metastases). Patients were randomized (1:1) to receive radiation therapy (70 Gy in 35 fractions) with either weekly cisplatin, 7 doses of 40 mg/m 2 , or cetuximab, loading dose of 400 mg/m 2  followed by 7 weekly doses of 250 mg/m 2 . The primary outcome was symptom severity assessed by the MD Anderson Symptom Inventory Head and Neck Symptom Severity Scale from baseline to 13 weeks postcompletion of radiation therapy using the area under the curve. Trial was registered on ClinicalTrials.gov: NCT01855451.
RESULTS


Between June 17, 2013, and June 7, 2018, 189 patients were enrolled, with 92 in cisplatin arm and 90 in cetuximab included in the main analysis. There was no difference in the primary endpoint of symptom severity; difference in area under the curve cetuximab-cisplatin was 0.05 (95% confidence interval [CI], -0.19, 0.30), P = .66. The T-score (mean number of ≥grade 3 acute adverse events) was 4.35 (standard deviation 2.48) in the cisplatin arm and 3.82 (standard deviation 1.8) in the cetuximab arm, P = .108. The 3-year failure-free survival rates were 93% (95% CI, 86%-97%) in the cisplatin arm and 80% (95% CI, 70%-87%) in the cetuximab arm (hazard ratio = 3.0 [95% CI, 1.2-7.7]); P = .015.
CONCLUSIONS


For patients with low-risk HPV-associated oropharyngeal cancer, radiation therapy and cetuximab had inferior failure-free survival without improvement in symptom burden or toxicity compared with radiation therapy and weekly cisplatin. Radiation therapy and cisplatin remain the standard of care.",2021,The 3 -year failure-free survival rates were 93% (95% CI: 86-97%) in the cisplatin arm and 80% (95% CI: 70-87%) in the cetuximab arm (hazard ratio = 3.0 (95% CI: 1.2-7.7);,"['and/or N2b-c if smoking history >10 pack years and/or distant metastases', 'low risk HPV associated oropharyngeal cancer (TROG 12.01) - a Trans-Tasman Radiation Oncology Group study', 'patients with low risk HPV associated oropharyngeal squamous cell carcinoma', 'Between 17 th  June 2013 and 7 th  June 2018, 189 patients were enrolled, with 92 on cisplatin arm and 90 on cetuximab included in the main analysis', 'enrolled patients with HPV associated oropharyngeal squamous cell carcinoma, AJCC 7 th  edition Stage III (excluding T1-2N1) or stage IV (excluding T4 and/or N3']","['radiotherapy', 'cetuximab', 'radiotherapy with weekly cisplatin or cetuximab', 'XXXX', 'radiotherapy and cisplatin', 'Radiotherapy and cisplatin', 'cisplatin', 'radiotherapy (70Gy in 35 fractions) with either weekly cisplatin', 'radiotherapy and weekly cisplatin']","['symptom burden and toxicity', '3 -year failure-free survival rates', 'symptom severity assessed by the MD Anderson Symptom Inventory Head and Neck Symptom Severity Scale', 'area under the curve (AUC', 'inferior failure-free survival']","[{'cui': 'C0445080', 'cui_str': 'Node stage N2b'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0243005', 'cui_str': 'Radiation oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2828150', 'cui_str': 'HPV positive oropharyngeal squamous cell carcinoma'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",189.0,0.276829,The 3 -year failure-free survival rates were 93% (95% CI: 86-97%) in the cisplatin arm and 80% (95% CI: 70-87%) in the cetuximab arm (hazard ratio = 3.0 (95% CI: 1.2-7.7);,"[{'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia. Electronic address: danny.rischin@petermac.org.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'University of Sydney, School of Psychology, Sydney Quality of Life Office, Sydney, Australia.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Kenny', 'Affiliation': ""Department of Radiation Oncology, Royal Brisbane & Women's Hospital, Brisbane, Australia; Faculty of Medicine, University of Queensland, Brisbane, Australia.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Porceddu', 'Affiliation': 'Faculty of Medicine, University of Queensland, Brisbane, Australia; Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wratten', 'Affiliation': 'Department of Radiation Oncology, Calvary Mater Hospital and University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Macann', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital and University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Jackson', 'Affiliation': 'Icon Cancer Centres, Gold Coast, Australia.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Bressel', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fisher', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Tsien', 'Initials': 'T', 'LastName': 'Fua', 'Affiliation': 'Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': ""Department of Radiation Oncology, Royal Brisbane & Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Brett G M', 'Initials': 'BGM', 'LastName': 'Hughes', 'Affiliation': ""Faculty of Medicine, University of Queensland, Brisbane, Australia; Department of Medical Oncology, Royal Brisbane & Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McGrath', 'Affiliation': 'Department of Medical Oncology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Lachlan', 'Initials': 'L', 'LastName': 'McDowell', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Corry', 'Affiliation': ""Genesiscare St Vincent's Hospital, Melbourne, Australia; Department of Medicine, University of Melbourne, Melbourne, Australia.""}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.04.015']
1380,34102298,Phase 3 Randomized Trial of Topical Steroid Versus Placebo for Prevention of Radiation Dermatitis in Patients With Head and Neck Cancer Receiving Chemoradiation.,"PURPOSE


Radiation dermatitis is one of the most common acute toxicities induced by chemoradiation therapy (CRT) for head and neck cancer (HNC). The benefit of topical steroids in the management of radiation dermatitis is still unclear. This phase 3, multi-institutional, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of topical steroids for radiation dermatitis in patients with locally advanced HNC receiving CRT.
METHODS AND MATERIALS


Eligible patients were scheduled to receive bilateral neck irradiation (≥66 Gy) with concurrent cisplatin (≥200 mg/m 2 ) as definitive or postoperative CRT. Patients were randomly assigned to receive either topical steroid or placebo when grade 1radiation dermatitis was observed or the total radiation dose reached 30 Gy. Basic skin care including gentle washing and moistening in the head and neck region was performed in both groups. The primary endpoint was the frequency of grade ≥2 radiation dermatitis, in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Grading of radiation dermatitis was performed by independent central review using photographs taken weekly.
RESULTS


A total of 211 patients were enrolled (intention to treat: steroid 101 and placebo 102). The frequency of grade ≥2 radiation dermatitis was not significantly reduced with the steroid (73.3%; 95% confidence interval, 64.6%-81.9%) compared with the placebo (80.4%; 95% confidence interval, 72.7%-88.1%; P = .23), whereas the steroid significantly reduced the frequency of grade ≥3 radiation dermatitis (13.9% vs 25.5%; P = .034). No significant differences in adverse events, including local infection or compliance with CRT, were observed between the groups.
CONCLUSIONS


Topical steroid may reduce the severity of radiation dermatitis in patients with HNC and thus may become an important therapeutic tool in the management of radiation dermatitis.",2021,"No significant differences in adverse events including local infection or in CRT compliance were seen between the groups.
","['head and neck cancer patients receiving chemoradiation', 'head and neck cancer (HNC', 'patients with locally advanced HNC receiving CRT', 'HNC patients', 'Eligible patients were scheduled to receive', '211 patients were enrolled (intention to treat: steroid 101 and placebo 102']","['topical steroids', 'chemoradiotherapy (CRT', 'placebo', 'topical steroid or placebo', 'bilateral neck irradiation (≥ 66 Gy) with concurrent cisplatin (≥ 200 mg/m2) as definitive or postoperative CRT', 'topical steroid']","['adverse events including local infection or in CRT compliance', 'efficacy and safety', 'frequency of ≥ grade 2 radiation dermatitis', 'severity of radiation dermatitis', 'frequency of ≥ grade 2 radiation dermatitis, in accordance with NCI Common Terminology Criteria for Adverse Events version 4.0', 'Grading of radiation dermatitis', 'frequency of ≥ grade 3 radiation dermatitis']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",211.0,0.258001,"No significant differences in adverse events including local infection or in CRT compliance were seen between the groups.
","[{'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Yokota', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Japan.'}, {'ForeName': 'Sadamoto', 'Initials': 'S', 'LastName': 'Zenda', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: szenda@east.ncc.go.jp.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Ota', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Head & Neck Oncology, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Takenori', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tachibana', 'Affiliation': 'Division of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Toshiyasu', 'Affiliation': 'Department of Radiation Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Homma', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tempei', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Department of Clinical Trial Data Management, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Mashiko', 'Affiliation': 'Suxac Inc, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hamauchi', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Japan.'}, {'ForeName': 'Kuniko', 'Initials': 'K', 'LastName': 'Tominaga', 'Affiliation': 'Division of Nursing, Shizuoka Cancer Center, Sunto-gun, Japan.'}, {'ForeName': 'Shinobu', 'Initials': 'S', 'LastName': 'Ishii', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Otani', 'Affiliation': 'Division of Nursing, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Orito', 'Affiliation': 'Division of Nursing, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Tokyo, Japan.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.05.133']
1381,34114619,"Response to the Letter to the Editor from Valdemar Grill et al: ""Islet Function and Insulin Sensitivity in Latent Autoimmune Diabetes in Adults Taking Sitagliptin: A Randomized Trial"".",,2021,,['latent autoimmune diabetes in adults taking sitagliptin'],[],['Islet function and insulin sensitivity'],"[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0443146', 'cui_str': 'Autoimmune reaction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]",[],"[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",,0.109723,,"[{'ForeName': 'Huiying', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiangbing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Endocrinology, Metabolism and Nutrition, Rutgers University-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab413']
1382,34111992,Short-term Efficacy of Ultrasonographic Guidance for Intra-articular Corticosteroid Injection in Hallux Rigidus: A Single-Blind Randomized Controlled Trial.,"BACKGROUND


Multiple considerations should be taken before standardizing a clinical procedure such as efficacy, safety, or the cost. The aim of this study was to compare the effects of landmark-guided vs ultrasonography-guided intra-articular injection of corticosteroid into the first metatarsophalangeal joint cavity to reduce pain and dysfunction in patients with hallux rigidus.
METHODS


We carried out a single-blind randomized controlled trial with 2 parallel arms in an outpatient clinic affiliated with a medical university. In total, 50 participants (35 women) with the mean (SD) age of 49.8 (10.3) years were randomly allocated to landmark-guided or ultrasonography-guided groups (each n = 25). Each patient received a single intra-articular injection of 40-mg methylprednisolone plus 1 mL lidocaine into the affected first metatarsophalangeal joint. The primary outcome was joint pain and the secondary outcome was the American Orthopaedic Foot & Ankle Society score. We measured the outcomes at baseline and 2 and 6 weeks after the intervention.
RESULTS


Six weeks after the injections, there were no statistically significant differences between the study groups in pain reduction and increase in the American Orthopaedic Foot & Ankle Society scores ( P  = .131 and .241, respectively). We did not find any complications for the injections in both groups. There were statistically significant changes within each group in pain and the scores for the landmark ( P  < .001, and  P  = .007), and ultrasonography groups (both  P  < .001).
CONCLUSION


Landmark guidance is as effective as ultrasonographic guidance for intra-articular injection in patients with hallux rigidus. A single intra-articular injection of 40 mg methylprednisolone plus 1 mL lidocaine is an efficient and safe therapeutic measure for decreasing joint pain and maintaining its function, at least for 6 weeks.
LEVEL OF EVIDENCE


Level I, high-quality prospective randomized study.",2021,", there were no statistically significant differences between the study groups in pain reduction and increase in the American Orthopaedic Foot & Ankle Society scores ( P  = .131 and .241, respectively).","['Hallux Rigidus', '50 participants (35 women) with the mean (SD) age of 49.8 (10.3) years', 'patients with hallux rigidus', 'outpatient clinic affiliated with a medical university']","['methylprednisolone plus 1 mL lidocaine', 'landmark-guided or ultrasonography-guided groups', 'landmark-guided vs ultrasonography-guided intra-articular injection of corticosteroid', 'Ultrasonographic Guidance']","['American Orthopaedic Foot & Ankle Society score', 'joint pain', 'pain and dysfunction', 'American Orthopaedic Foot & Ankle Society scores', 'pain', 'Level', 'pain reduction', 'joint pain and maintaining its function']","[{'cui': 'C0264134', 'cui_str': 'Acquired hallux rigidus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",50.0,0.204823,", there were no statistically significant differences between the study groups in pain reduction and increase in the American Orthopaedic Foot & Ankle Society scores ( P  = .131 and .241, respectively).","[{'ForeName': 'Seyede Zahra', 'Initials': 'SZ', 'LastName': 'Emami Razavi', 'Affiliation': 'Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohaddeseh', 'Initials': 'M', 'LastName': 'Azadvari', 'Affiliation': 'Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid R', 'Initials': 'HR', 'LastName': 'Fateh', 'Affiliation': 'Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Ghahvechi Akbari', 'Affiliation': ""Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Shahrbanoo', 'Initials': 'S', 'LastName': 'Kazemi', 'Affiliation': 'Ziaeian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Rezaee', 'Affiliation': 'Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Foot & ankle international,['10.1177/10711007211015988']
1383,34110840,Brief Alcohol Screening and Intervention for Community College Students (BASICCS): Feasibility and preliminary efficacy of web-conferencing BASICCS and supporting automated text messages.,"Objective:  The Brief Alcohol Screening and Intervention for College Students (BASICS; Dimeff et al., 1999) is an evidence-based approach to reduce high-risk drinking and associated harms; however, implementation may present challenges for community colleges (CCs) that have limited budgets and mostly non-residential students. We examined feasibility, acceptability, and efficacy of BASICS for CC students (BASICCS) delivered remotely via web-conferencing with supporting automated text messages.  Method:  Participants included 142 CC students who reported exceeding National Institute on Alcohol Abuse and Alcoholism (NIAAA's) weekly low-risk drinking recommendations and/or heavy episodic drinking (HED). Participants were randomized to BASICCS or assessment-only control (AOC) and completed 1- and 3-month follow-up assessments.  Results:  Most students liked the personalized information in the program and found the web-conferencing platform useful, however intervention completion rate was 56%. Significant differences were found between BASICCS and AOC. At 1-month, individuals in BASICCS had 33% fewer alcohol consequences than those in AOC. At 3-month follow-up, individuals in BASICCS had lower estimated peak blood alcohol concentration, 29% fewer drinks per week, 62% fewer episodes of HED, and 24% fewer consequences than those in AOC.  Conclusions:  BASICCS showed evidence of being acceptable and the technology proved feasible, although the intervention completion rate in the non-treatment-seeking volunteer sample was modest. Preliminary evidence does suggest BASICCS shows promise in reducing alcohol use and consequences. Technology-based platforms could be a viable prevention solution for CC students. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Most students liked the personalized information in the program and found the web-conferencing platform useful, however intervention completion rate was 56%.","[""Participants included 142 CC students who reported exceeding National Institute on Alcohol Abuse and Alcoholism (NIAAA's) weekly low-risk drinking recommendations and/or heavy episodic drinking (HED"", 'Community College Students (BASICCS']","['BASICCS or assessment-only control (AOC) and completed 1- and 3-month follow-up assessments', 'Alcohol Screening and Intervention', 'Brief Alcohol Screening and Intervention', 'web-conferencing BASICCS and supporting automated text messages']","['peak blood alcohol concentration', 'alcohol consequences']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1955975', 'cui_str': 'National Institute on Alcohol Abuse and Alcoholism'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0557812', 'cui_str': 'Community college'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}]",,0.0254259,"Most students liked the personalized information in the program and found the web-conferencing platform useful, however intervention completion rate was 56%.","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Cadigan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Kilmer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Cronce', 'Affiliation': 'Department of Counseling Psychology and Human Services, University of Oregon.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Walter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Department of Health Behavior and Health Systems, University of North Texas Health Science Center.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000745']
1384,34117592,Correlates of Adherence to the Dapivirine Vaginal Ring for HIV-1 Prevention.,"Understanding characteristics associated with adherence to pre-exposure prophylaxis (PrEP) methods for HIV-1 prevention may assist with optimizing implementation efforts. The dapivirine vaginal ring is a novel topical PrEP delivery method. Using data from a randomized, double-blind, placebo-controlled, phase III trial of the dapivirine vaginal ring conducted in four African countries, generalized estimating equation models were used to evaluate correlates of ring adherence. Two levels of quarterly dapivirine blood plasma, and dapivirine released from returned rings defined measures of adherence for recent and cumulative use, respectively. Time on study, calendar time, primary partner knowledge that the participant was taking part in the study, and use of long-acting contraceptive methods were associated with ring adherence whereas younger age, ring worries, condom use, episodes of menstrual bleeding and vaginal washing were associated with non-adherence. These findings may be useful for recruitment into future clinical studies and dapivirine ring implementation efforts.",2021,"Two levels of quarterly dapivirine blood plasma, and dapivirine released from returned rings defined measures of adherence for recent and cumulative use, respectively.",[],['placebo'],"['ring worries, condom use, episodes of menstrual bleeding and vaginal washing', 'quarterly dapivirine blood plasma, and dapivirine']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.100636,"Two levels of quarterly dapivirine blood plasma, and dapivirine released from returned rings defined measures of adherence for recent and cumulative use, respectively.","[{'ForeName': 'Marla J', 'Initials': 'MJ', 'LastName': 'Husnik', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'Sufia S', 'Initials': 'SS', 'LastName': 'Dadabhai', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Blantyre, Malawi.'}, {'ForeName': 'Zakir', 'Initials': 'Z', 'LastName': 'Gaffoor', 'Affiliation': 'South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Nitesha', 'Initials': 'N', 'LastName': 'Jeenarain', 'Affiliation': 'South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Flavia Matovu', 'Initials': 'FM', 'LastName': 'Kiweewa', 'Affiliation': 'MU-JHU Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Livant', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, USA.'}, {'ForeName': 'Leila E', 'Initials': 'LE', 'LastName': 'Mansoor', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.'}, {'ForeName': 'Brenda Gati', 'Initials': 'BG', 'LastName': 'Mirembe', 'Affiliation': 'MU-JHU Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, School of Clinical Medicine, Johannesburg, South Africa.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Siva', 'Affiliation': 'South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'National Institutes of Health, Bethesda, USA.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""RTI International, Women's Global Health Imperative, San Francisco, CA, USA.""}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'University of Washington, Seattle, USA. jbaeten@uw.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-021-03231-x']
1385,34117198,Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Tdap Vaccine: Randomized Phase IIIb Trial in Healthy Participants 9-60 Years of Age in the Philippines.,"BACKGROUND


Incorporating dengue vaccination into existing childhood vaccination programs could increase vaccine coverage. This study assessed the safety and immunogenicity of concomitant versus sequential administration of the combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine and the tetravalent dengue vaccine (CYD-TDV).
METHODS


This phase IIIb, randomized, open-label, multicenter study was conducted in the Philippines in individuals 9-≤60 years of age (NCT02992418). Participants were to receive 3 CYD-TDV doses 6 months apart, the first dose administered either concomitantly or sequentially (28 days post-Tdap). Antibody levels were measured at baseline and 28 days post-first doses of Tdap vaccine and CYD-TDV, using enzyme-linked immunosorbent assay (pertussis, tetanus), micrometabolic inhibition test-toxin neutralization assay (diphtheria) and plaque reduction neutralization test (dengue). Immunogenicity was assessed for all participants, and statistical analysis reported for baseline dengue seropositive participants. Safety was assessed throughout.
RESULTS


Among 688 randomized participants, 629 (91.4%) were baseline dengue seropositive (concomitant group, n = 314 and sequential group, n = 315). After the first dose, non-inferiority of immune responses between concomitant and sequential vaccination was achieved; between-group geometric mean antibody concentration ratios were close to 1 for anti-PT, anti-FHA, anti-PRN and anti-FIM, between-group differences in percent achieving seroprotection (titers ≥0.1 IU/mL) were 0.26% (diphtheria) and 0.66% (tetanus), and between-group geometric mean antibody titer ratios were close to 1 for dengue serotypes 1-4. Safety profiles in both study groups were comparable.
CONCLUSIONS


CYD-TDV and Tdap vaccine administered concomitantly or sequentially in baseline dengue seropositive participants elicited comparable immunogenicity and safety profiles.",2021,"Antibody levels were measured at baseline and 28 days post-first doses of Tdap vaccine and CYD-TDV, using enzyme-linked immunosorbent assay (pertussis, tetanus), micrometabolic inhibition test-toxin neutralization assay (diphtheria) and plaque reduction neutralization test (dengue).","['Philippines in individuals 9-≤60 years of age (NCT02992418', 'Healthy Participants 9-60 Years of Age in the Philippines', '688 randomized participants, 629 (91.4%) were baseline dengue seropositive (concomitant group, n = 314 and sequential group, n = 315']","['Tdap Vaccine', 'CYD-TDV and Tdap vaccine', 'Tetravalent Dengue Vaccine', 'combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine and the tetravalent dengue vaccine (CYD-TDV', 'Tdap vaccine and CYD-TDV, using enzyme-linked immunosorbent assay (pertussis, tetanus), micrometabolic inhibition test-toxin neutralization assay (diphtheria) and plaque reduction neutralization test (dengue']","['geometric mean antibody concentration ratios', 'immunogenicity and safety profiles', 'Immunogenicity and Safety', 'safety and immunogenicity', 'geometric mean antibody titer ratios', 'Safety', 'Immunogenicity', 'Antibody levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040555', 'cui_str': 'Toxoid'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0201783', 'cui_str': 'Inhibition test'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027944', 'cui_str': 'Neutralization Tests'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",688.0,0.268866,"Antibody levels were measured at baseline and 28 days post-first doses of Tdap vaccine and CYD-TDV, using enzyme-linked immunosorbent assay (pertussis, tetanus), micrometabolic inhibition test-toxin neutralization assay (diphtheria) and plaque reduction neutralization test (dengue).","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Santos', 'Affiliation': ""From the Philippine Children's Medical Center, Quezon City, The Philippines.""}, {'ForeName': 'May Emmeline', 'Initials': 'ME', 'LastName': 'Montellano', 'Affiliation': 'Far Eastern University Nicanor Reyes Medical Foundation, Quezon City, The Philippines.'}, {'ForeName': 'Rontgene', 'Initials': 'R', 'LastName': 'Solante', 'Affiliation': 'Medical Center Manila, Manila, The Philippines.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Perreras', 'Affiliation': 'Research Institute for Tropical Medicine, Alabang Muntinlupa City, The Philippines.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Meyer', 'Affiliation': 'Sanofi Pasteur, France.'}, {'ForeName': 'Myew-Ling', 'Initials': 'ML', 'LastName': 'Toh', 'Affiliation': 'Sanofi Pasteur, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Zocchetti', 'Affiliation': 'Sanofi Pasteur, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vigne', 'Affiliation': 'Sanofi Pasteur, France.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Mascareñas', 'Affiliation': 'Sanofi Pasteur, Mexico City, Mexico.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000003220']
1386,34446469,Early high antibody-titre convalescent plasma for hospitalised COVID-19 patients: DAWn-plasma.,"BACKGROUND


Several randomised clinical trials have studied convalescent plasma (CP) for COVID-19 using different protocols, with different SARS-CoV-2 neutralising-antibody-titres, at different time-points and severities of illness.
METHODS


In the prospective multicentre DAWN-plasma trial, adult patients hospitalised with COVID-19 were randomised to 4 units of open-label convalescent plasma combined with standard of care (intervention group) or standard of care alone (control group). Plasma from donors with neutralising-antibody-titres (NT50) ≥1/320 was the product of choice for the study.
RESULTS


Between May 2nd, 2020 and January 26th, 2021, 320 patients were randomised to convalescent plasma and 163 patients to the control group according to a 2:1 allocation scheme. A median volume of 884 mL convalescent plasma (IQR 806-906 mL) was administered, and 80.68% of the units came from donors with neutralising-antibody-titres (NT50) ≥1/320. Median time from onset of symptoms to randomisation was 7 days. The proportion of patients alive and free of mechanical ventilation on Day 15 was not different between both groups (convalescent plasma: 83.74% (n=267)  versus  control: 84.05% (n=137) - Odds ratio 0.99 (0.59-1.66) - p-value=0.9772). The intervention did not change the natural course of antibody titres. The number of serious or severe adverse events was similar in both study arms, and transfusion-related side effects were reported in 19/320 patients in the intervention group (5.94%).
CONCLUSIONS


Transfusion of 4 units of convalescent plasma with high neutralising-antibody-titres early in hospitalised COVID-19 patients did not result in a significant improvement of the clinical status, or a reduced mortality.",2021,"The number of serious or severe adverse events was similar in both study arms, and transfusion-related side effects were reported in 19/320 patients in the intervention group (5.94%).
","['adult patients hospitalised with COVID-19', 'hospitalised COVID-19 patients', 'Between May 2nd, 2020 and January 26th, 2021, 320 patients were randomised to convalescent plasma and 163 patients to the control group according to a 2:1 allocation scheme']",['open-label convalescent plasma combined with standard of care (intervention group) or standard of care alone (control group'],"['natural course of antibody titres', 'transfusion-related side effects', 'Median time', 'number of serious or severe adverse events', 'proportion of patients alive and free of mechanical ventilation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",320.0,0.0586794,"The number of serious or severe adverse events was similar in both study arms, and transfusion-related side effects were reported in 19/320 patients in the intervention group (5.94%).
","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Devos', 'Affiliation': 'Department of Hematology, University Hospitals Leuven and Department of Microbiology and Immunology, Laboratory of Molecular Immunology (Rega Institute), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Van Thillo', 'Affiliation': 'Center for Cancer Biology, Vlaams Instituut voor Biotechnologie (VIB), Leuven and Center for Human Genetics, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Compernolle', 'Affiliation': 'Belgian Red Cross, Blood Services, Mechelen, Belgium. Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Tomé', 'Initials': 'T', 'LastName': 'Najdovski', 'Affiliation': 'Belgian Red Cross, Service du Sang, Namur, Belgium.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Romano', 'Affiliation': 'Immune Response Service; Infectious Diseases in Humans Scientific Directorate, Sciensano, Brussels, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dauby', 'Affiliation': 'Department of Infectious Diseases, CHU Saint-Pierre, Universite Libre de Bruxelles (ULB), School of Public Health, Universite Libre de Bruxelles (ULB), Institute for Medical Immunology, Universite Libre de Bruxelles (ULB), Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Jadot', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, and Department of Infectious diseases, CHC Mont Legia, Liege, Belgium.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Leys', 'Affiliation': 'Department of Pulmonary Medicine, AZ Groeninge, Kortrijk, Belgium.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Maillart', 'Affiliation': 'Department of Infectious Diseases, Brugmann University Hospital, Brussels, Belgium.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Loof', 'Affiliation': 'Department of Respiratory Medicine, AZ Maria Middelares Gent, Ghent, Belgium. Department of Respiratory Medicine, AZ Sint-Vincentius Deinze, Deinze, Belgium.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Seyler', 'Affiliation': 'Department of Infectious Diseases and Internal Medicine, UZ Brussel Hospital, Brussels, Belgium.'}, {'ForeName': 'Martial', 'Initials': 'M', 'LastName': 'Moonen', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Centre Hospitalier Regional (CHR), Liege, Belgium.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Moutschen', 'Affiliation': 'Infectious Diseases and General Internal Medicine, CHU de Liege, ULiege, Belgium.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Van Regenmortel', 'Affiliation': 'Department of Intensive Care Medicine, Ziekenhuis Netwerk Antwerpen Campus Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Ariën', 'Affiliation': 'Virology Unit, Institute of Tropical Medicine Antwerp, Antwerp and Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Barbezange', 'Affiliation': 'National Influenza Centre, Sciensano, Brussels, Belgium.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Betrains', 'Affiliation': 'Department of General Internal Medicine, University Hospitals Leuven, Leuven and Department of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Mutien', 'Initials': 'M', 'LastName': 'Garigliany', 'Affiliation': 'University of Liege, Faculty of Veterinary Medicine, Animal Pathology, Liege, Belgium.'}, {'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Engelen', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Iwein', 'Initials': 'I', 'LastName': 'Gyselinck', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Respiratory Diseases UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Maes', 'Affiliation': 'KU Leuven, Rega Institute for Medical Research, Clinical and Epidemiological Virology, Leuven, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schauwvlieghe', 'Affiliation': 'Department of Haematology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Liesenborghs', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': 'I-BioStat, KU Leuven, Leuven, Belgium and University Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Meyfroidt', 'Affiliation': 'Department of Intensive Care Medicine, University Hospitals Leuven, and Department of Cellular and Molecular Medicine, Laboratory of Intensive Care Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.01724-2021']
1387,34446390,Ticagrelor or Prasugrel in Patients With Acute Coronary Syndrome in Relation to Estimated Glomerular Filtration Rate.,"OBJECTIVES


The aim of this study was to assess the safety and efficacy of ticagrelor versus prasugrel for patients with acute coronary syndrome (ACS) according to their estimated glomerular filtration rates (eGFRs).
BACKGROUND


The outcomes of ticagrelor versus prasugrel in patients with ACS according to eGFR have not been defined.
METHODS


Patients (n = 4,012) were categorized into 3 groups: low eGFR (<60 mL/min/1.73 m 2 ), intermediate eGFR (≥60 and <90 mL/min/1.73 m 2 ), and high eGFR (≥90 mL/min/1.73 m 2 ). The primary endpoint was a composite of all-cause death, myocardial infarction, and stroke; the secondary safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding, both at 1 year.
RESULTS


Patients with low eGFRs had a higher risk for the primary endpoint compared with patients with intermediate eGFRs (adjusted HR: 1.89; 95% CI: 1.46-2.46]) and those with high eGFRs (adjusted HR: 2.33; 95% CI: 1.57-3.46). A risk excess for low eGFR was also observed for bleeding (adjusted HR: 1.55 [95% CI: 1.12-2.13] vs intermediate eGFR; adjusted HR: 1.59 [95% CI: 1.01-2.50] vs high eGFR). However, eGFR did not affect the relative efficacy and safety of ticagrelor versus prasugrel. In patients with low eGFR, the primary endpoint occurred in 20.5% with ticagrelor and in 14.7% with prasugrel (HR: 1.47; 95% CI: 1.04-2.08; P = 0.029); there was no significant difference in bleeding.
CONCLUSIONS


These results show that among patients with ACS, reduction of eGFR is associated with increased risk for ischemic and bleeding events but has no significant impact on the relative efficacy and safety of ticagrelor versus prasugrel. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome [ISAR-REACT 5]; NCT01944800).",2021,"RESULTS


Patients with low eGFRs had a higher risk for the primary endpoint compared with patients with intermediate eGFRs (adjusted hazard ratio [HR]: 1.89; 95% confidence interval [CI]: 1.46-2.46]) and those with high eGFRs (adjusted HR: 2.33; 95% CI: 1.57-3.46).","['Patients With Acute Coronary Syndrome [ISAR-REACT 5', 'Patients With Acute Coronary Syndrome', 'patients with ACS', 'Patients (n\xa0=\xa04,012) were categorized into 3 groups: low eGFR (<60', 'patients with acute coronary syndrome (ACS']","['Ticagrelor or Prasugrel', 'ticagrelor versus prasugrel', 'prasugrel', 'ticagrelor', 'Ticagrelor Versus Prasugrel']","['safety and efficacy', 'composite of all-cause death, myocardial infarction, and stroke; the secondary safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding, both at 1 year', 'relative efficacy and safety', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",4012.0,0.0919195,"RESULTS


Patients with low eGFRs had a higher risk for the primary endpoint compared with patients with intermediate eGFRs (adjusted hazard ratio [HR]: 1.89; 95% confidence interval [CI]: 1.46-2.46]) and those with high eGFRs (adjusted HR: 2.33; 95% CI: 1.57-3.46).","[{'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'Department of Cardiology and Intensive Care, Medical Campus Lake Constance, Friedrichshafen, Germany. Electronic address: jochen.wohrle@t-online.de.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Seeger', 'Affiliation': 'Department of Cardiology and Intensive Care, Medical Campus Lake Constance, Friedrichshafen, Germany.'}, {'ForeName': 'Shqipdona', 'Initials': 'S', 'LastName': 'Lahu', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Bernlochner', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Senta', 'Initials': 'S', 'LastName': 'Gewalt', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Menichelli', 'Affiliation': 'Ospedale Fabrizio Spaziani, Cardiology, Frosinone, Italy.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Helios Amper-Klinikum Dachau, Cardiology & Pneumology, Dachau, Germany.'}, {'ForeName': 'Willibald', 'Initials': 'W', 'LastName': 'Hochholzer', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Center Freiburg Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany; Klinik der Universität München, Ludwig-Maximilians-University, Cardiology, Munich, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, USA.'}, {'ForeName': 'Rayyan', 'Initials': 'R', 'LastName': 'Hemetsberger', 'Affiliation': 'Heart Center Bad Segeberg, Bad Segeberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Valina', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Center Freiburg Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}, {'ForeName': 'Erion', 'Initials': 'E', 'LastName': 'Xhepa', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hapfelmeier', 'Affiliation': 'Technical University of Munich, School of Medicine, Institute of General Practice and Health Services Research, Munich, Germany.'}, {'ForeName': 'Hendrik B', 'Initials': 'HB', 'LastName': 'Sager', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joner', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Center Bad Segeberg, Bad Segeberg, Germany.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Franz Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Center Freiburg Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schüpke', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Gjin', 'Initials': 'G', 'LastName': 'Ndrepepa', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2021.06.028']
1388,34450361,The effects of active break and postural shift interventions on recovery from and recurrence of neck and low back pain in office workers: A 3-arm cluster-randomized controlled trial.,"OBJECTIVES


To investigate the efficacy of active break and postural shift interventions aimed to reduce sitting discomfort on recovery duration and recurrence of neck and low back pain among high-risk office workers.
METHODS


A 3-arm cluster-randomized controlled trial with 12-month follow-up was conducted in 193 healthy but high-risk office workers. Participants in the intervention groups received custom-designed apparatus to facilitate either active breaks or postural shifts to reduce sitting discomfort at work. Participants in a control group received a placebo seat pad. Incidence of neck and low back pain with pain intensity and disability level was recorded monthly. Main outcome measures were recovery time and recurrent rate of neck and low back pain. Analyses were performed using log rank test and Cox proportional hazard models.
RESULTS


Median time to recovery in those receiving active break and postural shift interventions (1 month) was significantly shorter than those in the control group (2 months). Neck and low back pain recurrent rates for the active break, postural shift, and control groups were 21%, 18%, and 44%, respectively. Hazard rate (HR) ratios after adjusting for biopsychosocial factors indicated a protective effect of active break and postural shift interventions for neck and low back pain recurrence (HR adj  0.22, 95% CI 0.06-0.83 for active breaks and HR adj  0.35, 95% CI 0.16-0.77 for postural shift).
CONCLUSION


Active break and postural shift interventions shortened recovery time and reduced recurrence of neck and low back pain among high-risk office workers.",2021,"Neck and low back pain recurrent rates for the active break, postural shift, and control groups were 21%, 18%, and 44%, respectively.","['office workers', 'high-risk office workers', '193 healthy but high-risk office workers']","['custom-designed apparatus to facilitate either active breaks or postural shifts to reduce sitting discomfort at work', 'placebo seat pad', 'active break and postural shift interventions', 'Active break and postural shift interventions']","['Incidence of neck and low back pain with pain intensity and disability level', 'Hazard rate (HR) ratios', 'recovery time and recurrent rate of neck and low back pain', 'recovery duration and recurrence of neck and low back pain', 'Neck and low back pain recurrent rates', 'recovery time and reduced recurrence of neck and low back pain', 'recovery from and recurrence of neck and low back pain', 'protective effect of active break and postural shift interventions for neck and low back pain recurrence']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.14121,"Neck and low back pain recurrent rates for the active break, postural shift, and control groups were 21%, 18%, and 44%, respectively.","[{'ForeName': 'Nipaporn', 'Initials': 'N', 'LastName': 'Akkarakittichoke', 'Affiliation': 'Inter-Department Program of Biomedical Sciences, Faculty of Graduate School, Chulalongkorn University, Bangkok, Thailand. Electronic address: nipaporn.pt@gmail.com.'}, {'ForeName': 'Pooriput', 'Initials': 'P', 'LastName': 'Waongenngarm', 'Affiliation': 'Faculty of Health Science Technology, HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand; Department of Physical Therapy, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok, Thailand. Electronic address: golffy_pw@hotmail.com.'}, {'ForeName': 'Prawit', 'Initials': 'P', 'LastName': 'Janwantanakul', 'Affiliation': 'Department of Physical Therapy, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok, Thailand. Electronic address: prawit.j@chula.ac.th.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2021.102451']
1389,34454281,Cortical mechanisms underlying variability in intermittent theta-burst stimulation-induced plasticity: A TMS-EEG study.,"OBJECTIVE


To test the hypothesis that intermittent theta burst stimulation (iTBS) variability depends on the ability to engage specific neurons in the primary motor cortex (M1).
METHODS


In a sham-controlled interventional study on 31 healthy volunteers, we used concomitant transcranial magnetic stimulation (TMS) and electroencephalography (EEG). We compared baseline motor evoked potentials (MEPs), M1 iTBS-evoked EEG oscillations, and resting-state EEG (rsEEG) between subjects who did and did not show MEP facilitation following iTBS. We also investigated whether baseline MEP and iTBS-evoked EEG oscillations could explain inter and intraindividual variability in iTBS aftereffects.
RESULTS


The facilitation group had smaller baseline MEPs than the no-facilitation group and showed more iTBS-evoked EEG oscillation synchronization in the alpha and beta frequency bands. Resting-state EEG power was similar between groups and iTBS had a similar non-significant effect on rsEEG in both groups. Baseline MEP amplitude and beta iTBS-evoked EEG oscillation power explained both inter and intraindividual variability in MEP modulation following iTBS.
CONCLUSIONS


The results show that variability in iTBS-associated plasticity depends on baseline corticospinal excitability and on the ability of iTBS to engage M1 beta oscillations.
SIGNIFICANCE


These observations can be used to optimize iTBS investigational and therapeutic applications.",2021,Resting-state EEG power was similar between groups and iTBS had a similar non-significant effect on rsEEG in both groups.,['31 healthy volunteers'],"['concomitant transcranial magnetic stimulation (TMS) and electroencephalography (EEG', 'intermittent theta burst stimulation (iTBS']","['Resting-state EEG power', 'Baseline MEP amplitude and beta iTBS-evoked EEG oscillation', 'baseline motor evoked potentials (MEPs), M1 iTBS-evoked EEG oscillations, and resting-state EEG (rsEEG', 'iTBS-evoked EEG oscillation synchronization', 'smaller baseline MEPs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",31.0,0.0429334,Resting-state EEG power was similar between groups and iTBS had a similar non-significant effect on rsEEG in both groups.,"[{'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Leodori', 'Affiliation': 'I.R.C.C.S Neuromed, Pozzilli, Italy; Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fabbrini', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Maria Ilenia', 'Initials': 'MI', 'LastName': 'De Bartolo', 'Affiliation': 'I.R.C.C.S Neuromed, Pozzilli, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Costanzo', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Asci', 'Affiliation': 'I.R.C.C.S Neuromed, Pozzilli, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Palma', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Belvisi', 'Affiliation': 'I.R.C.C.S Neuromed, Pozzilli, Italy; Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Conte', 'Affiliation': 'I.R.C.C.S Neuromed, Pozzilli, Italy; Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Berardelli', 'Affiliation': 'I.R.C.C.S Neuromed, Pozzilli, Italy; Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy. Electronic address: alfredo.berardelli@uniroma1.it.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2021.06.021']
1390,34454260,The effects of tapentadol and oxycodone on central processing of tonic pain.,"OBJECTIVE


The present study investigated differences between opioids to experimental tonic pain in healthy men.
METHODS


Twenty-one males participated in this cross-over-trial. Interventions twice daily were oxycodone (10 mg), tapentadol (50 mg) and placebo for 14 days. Tonic pain was induced on day 1, 4 and 14 by immersing the hand in 2 °C water for 120 s. Electroencephalography was recorded during test pain at baseline and after 14 days. Spectral analysis and source localization were investigated in predefined frequency bands.
RESULTS


A decreased perception of pain on day 4 persisted throughout the 14 days compared to baseline (p < 0.006). Oxycodone decreased the electroencephalography spectral power in the delta and theta bands and increased power in the alpha1, alpha2 and beta1 bands (p < 0.03). Tapentadol increased spectral power in the alpha1 band (p < 0.001). Source localization revealed that oxycodone decreased activity of the temporal and limbic region in the delta band, and frontal lobe in the alpha2 and beta1 bands, whereas tapentadol decreased alpha1 band activity in the temporal lobe compared to placebo.
CONCLUSION


Oxycodone and tapentadol reduced pain perception and changed the central processing of tonic pain.
SIGNIFICANCE


Different mechanisms of action were involved, where oxycodone affected cortical structures more than tapentadol.",2021,"Oxycodone decreased the electroencephalography spectral power in the delta and theta bands and increased power in the alpha1, alpha2 and beta1 bands (p < 0.03).","['Twenty-one males participated in this cross-over-trial', 'healthy men']","['tapentadol', 'placebo', 'Tapentadol', 'oxycodone', 'Oxycodone', 'opioids', 'Oxycodone and tapentadol', 'tapentadol and oxycodone']","['Tonic pain', 'perception of pain', 'alpha1 band activity', 'central processing of tonic pain', 'electroencephalography spectral power', 'pain perception', 'spectral power']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C2001271', 'cui_str': 'tapentadol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",21.0,0.0687352,"Oxycodone decreased the electroencephalography spectral power in the delta and theta bands and increased power in the alpha1, alpha2 and beta1 bands (p < 0.03).","[{'ForeName': 'Rasmus Bach', 'Initials': 'RB', 'LastName': 'Nedergaard', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Tine Maria', 'Initials': 'TM', 'LastName': 'Hansen', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Thomas Dahl', 'Initials': 'TD', 'LastName': 'Nissen', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Esben Bolvig', 'Initials': 'EB', 'LastName': 'Mark', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brock', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Asbjørn Mohr', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: amd@rn.dk.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2021.07.021']
1391,34087659,Perioperative supplemental oxygen and NT-proBNP concentrations after major abdominal surgery - A prospective randomized clinical trial.,"STUDY OBJECTIVE


Supplemental oxygen is a simple method to improve arterial oxygen saturation and might therefore improve myocardial oxygenation. Thus, we tested whether intraoperative supplemental oxygen reduces the risk of impaired cardiac function diagnosed with NT-proBNP and myocardial injury after noncardiac surgery (MINS) diagnosed with high-sensitivity Troponin T.
DESIGN


Parallel-arm double-blinded single-centre superiority randomized trial.
SETTING


Operating room and postoperative recovery area.
PATIENTS


260 patients over the age of 45 years at-risk for cardiovascular complications undergoing major abdominal surgery.
INTERVENTION


Administration of 80% versus 30% oxygen throughout surgery and for the first two postoperative hours.
MEASUREMENTS


The primary outcome was the postoperative maximum NT-proBNP concentration in both groups, which was assessed within 2 h after surgery, and on the first and third postoperative day. The secondary outcome was the incidence of MINS in both groups.
MAIN RESULTS


128 patients received 80% oxygen and 130 received 30% oxygen throughout surgery and for the first two postoperative hours. There was no significant difference in the median postoperative maximum NT-proBNP concentration between the 80% and the 30% oxygen group (989 pg.mL -1  [IQR 499; 2005] and 810 pg.mL -1  [IQR 409; 2386], effect estimate: 159 pg.mL -1 , 95%CI -123, 431, p = 0.704). There was no difference in the incidence of MINS between both groups. (p = 0.703).
CONCLUSIONS


There was no beneficial effect of perioperative supplemental oxygen administration on postoperative NT-proBNP concentration and MINS. It seems likely that supplemental oxygen has no effect on the release of NT-proBNP in patients at-risk for cardiovascular complications undergoing major abdominal surgery.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03366857. https://clinicaltrials.gov/ct2/results?cond=NCT+03366857&term=&cntry=&state=&city=&dist=.",2021,"There was no significant difference in the median postoperative maximum NT-proBNP concentration between the 80% and the 30% oxygen group (989 pg.mL -1  [IQR 499; 2005] and 810 pg.mL -1  [IQR 409; 2386], effect estimate: 159 pg.mL -1 , 95%CI -123, 431, p = 0.704).","['impaired cardiac function diagnosed with NT-proBNP and myocardial injury after noncardiac surgery (MINS) diagnosed with high-sensitivity Troponin T', '128 patients', 'patients at-risk for cardiovascular complications undergoing major abdominal surgery', '260 patients over the age of 45\xa0years at-risk for cardiovascular complications undergoing major abdominal surgery', 'after major abdominal surgery']","['Perioperative supplemental oxygen and NT-proBNP concentrations', 'intraoperative supplemental oxygen']","['incidence of MINS', 'arterial oxygen saturation', 'myocardial oxygenation', 'postoperative maximum NT-proBNP concentration', 'postoperative NT-proBNP concentration and MINS', 'median postoperative maximum NT-proBNP concentration']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.800838,"There was no significant difference in the median postoperative maximum NT-proBNP concentration between the 80% and the 30% oxygen group (989 pg.mL -1  [IQR 499; 2005] and 810 pg.mL -1  [IQR 409; 2386], effect estimate: 159 pg.mL -1 , 95%CI -123, 431, p = 0.704).","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reiterer', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kabon', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria. Electronic address: barbara.kabon@meduniwien.ac.at.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Taschner', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Falkner von Sonnenburg', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Graf', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Adamowitsch', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Starlinger', 'Affiliation': 'Department of Surgery, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Goshin', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Fraunschiel', 'Affiliation': 'IT Systems and Communications, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110379']
1392,34086752,Randomized controlled evaluation of the psychophysiological effects of social support stress management in healthy women.,"Considering the high and increasing prevalence of stress, approaches to mitigate stress-related biological processes become a matter of public health. Since supportive social interactions contribute substantially to mental and physical health, we set out to develop a social support stress management intervention and examined its effects on psychophysiological stress responses as well as self-reported stress in healthy women. In a parallel-group randomized controlled trial, registered in the DSRK (DRKS00017427), 53 healthy women were randomly assigned to a social support stress management or a waitlist control condition. All participants underwent a standardized psychosocial stress test where physiological and emotional stress responses were assessed by repeated measurements of cortisol, heart rate, heart rate variability and state anxiety. Also, all participants completed self-report questionnaires of perceived stress and social support at pre-intervention, post-intervention and follow-up four weeks later. Participants in the social support stress management showed a significantly attenuated integrated state anxiety response in comparison to those in the control condition, but conditions did not differ in any of the assessed physiological stress responses. The intervention significantly reduced perceived stress in comparison to the control condition, but perceived stress levels returned to baseline at follow-up. Our results indicated that the intervention had no effect on physiological responses to acute psychosocial stress, even though anxiety responses to stress were attenuated. However, the social support stress management intervention had a significant, albeit transient impact on perceived stress.",2021,"Participants in the social support stress management showed a significantly attenuated integrated state anxiety response in comparison to those in the control condition, but conditions did not differ in any of the assessed physiological stress responses.","['53 healthy women', 'healthy women']","['social support stress management or a waitlist control condition', 'social support stress management']","['integrated state anxiety response', 'physiological responses to acute psychosocial stress', 'physiological stress responses', 'cortisol, heart rate, heart rate variability and state anxiety', 'physiological and emotional stress responses', 'stress levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C2350025', 'cui_str': 'Physiological Stress Reaction'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0086209', 'cui_str': 'Emotional stress'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",53.0,0.00907514,"Participants in the social support stress management showed a significantly attenuated integrated state anxiety response in comparison to those in the control condition, but conditions did not differ in any of the assessed physiological stress responses.","[{'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Heimgartner', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Meier', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Grolimund', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Ponti', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Arpagaus', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Flurina', 'Initials': 'F', 'LastName': 'Kappeler', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gaab', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.'}]",PloS one,['10.1371/journal.pone.0252568']
1393,34082190,Does a short intervention with vibration foam roller recover lifeguards better after a water rescue? A pilot study.,"PURPOSE


The aim of this study was to analyze the effects of a recovery program based on foam roller with and without vibration on blood lactate clearance and perceived fatigue after a water rescue.
METHODS


A quasi-experimental crossover design was carried out to compare passive (PR) recovery and a short protocol of foam roller (FR) and vibration foam roller (VFR) recovery after a 100 m water rescue in 7 volunteer lifeguards. Blood lactate and perceived exertion were measured before and after the rescue, and also after the 5-min recovery intervention.
RESULTS


Blood lactate levels decrease significantly with foam roller (p = 0.013; effect size = 0.97) and vibration foam roller recovery (p < 0.001; effect size = 1.62). Passive recovery did not show significant differences clearing out blood lactate. Fatigue perceived decrease significantly with all the recovery methods, but foam roller has higher effects on the global fatigue and VFR on the legs.
CONCLUSION


FR and VFR clear out more blood lactate and decrease fatigue more than PR, with the subsequently increase of the physical conditioning to perform another effort.",2021,"RESULTS


Blood lactate levels decrease significantly with foam roller (p = 0.013; effect size = 0.97) and vibration foam roller recovery (p < 0.001; effect size = 1.62).",['7 volunteer lifeguards'],"['passive (PR) recovery and a short protocol of foam roller (FR) and vibration foam roller (VFR', 'recovery program based on foam roller with and without vibration']","['global fatigue and VFR on the legs', 'blood lactate and decrease fatigue', 'blood lactate clearance and perceived fatigue', 'Blood lactate and perceived exertion', 'blood lactate', 'Blood lactate levels', 'vibration foam roller recovery']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}]",,0.11503,"RESULTS


Blood lactate levels decrease significantly with foam roller (p = 0.013; effect size = 0.97) and vibration foam roller recovery (p < 0.001; effect size = 1.62).","[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Alonso-Calvete', 'Affiliation': 'REMOSS Research group, Facultade de Ciencias da Educación e do Deporte, Universidade de Vigo, Spain.'}, {'ForeName': 'Antón', 'Initials': 'A', 'LastName': 'Lage-Rey', 'Affiliation': 'REMOSS Research group, Facultade de Ciencias da Educación e do Deporte, Universidade de Vigo, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Lorenzo-Martínez', 'Affiliation': 'REMOSS Research group, Facultade de Ciencias da Educación e do Deporte, Universidade de Vigo, Spain. Electronic address: miguel.lorenzo.martinez@uvigo.es.'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Rey', 'Affiliation': 'REMOSS Research group, Facultade de Ciencias da Educación e do Deporte, Universidade de Vigo, Spain.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.04.089']
1394,34099518,"Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes.","OBJECTIVE


Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets.
RESEARCH DESIGN AND METHODS


This single-arm, multicenter, prospective study enrolled 112 children (age 6-13.9 years) and 129 adults (age 14-70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA 1c  and percent time in sensor glucose range 70-180 mg/dL (""time in range"").
RESULTS


A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA 1c  was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% [60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol],  P  < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol],  P  < 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both  P  < 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75],  P  < 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure.
CONCLUSIONS


This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA 1c  levels and time in target glucose range with a very low occurrence of hypoglycemia.",2021,This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA 1c  levels and time in target glucose range with a very low occurrence of hypoglycemia.,"['235 participants (98% of enrolled, including 111 children and 124 adults) completed the study', 'Pediatric and Adult Participants With Type 1 Diabetes', '112 children (age 6-13.9 years) and 129 adults (age 14-70 years']","['Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets']","['incidence of severe hypoglycemia and diabetic ketoacidosis', 'severe hypoglycemia events', 'HbA 1c', 'time in hypoglycemia', 'change in HbA 1c  and percent time in sensor glucose range 70-180 mg/dL (""time in range']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0336563', 'cui_str': 'Artificial pancreas'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}]",112.0,0.05499,This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA 1c  levels and time in target glucose range with a very low occurrence of hypoglycemia.,"[{'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': 'Division of Endocrinology, Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, GA.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Levy', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Criego', 'Affiliation': 'International Diabetes Center, Park Nicollet Pediatric Endocrinology, Minneapolis, MN.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hansen', 'Affiliation': 'Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY.'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Anders L', 'Initials': 'AL', 'LastName': 'Carlson', 'Affiliation': 'International Diabetes Center, Park Nicollet, HealthPartners, Minneapolis, MN.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center, Park Nicollet, HealthPartners, Minneapolis, MN.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Sherr', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Sanjeev N', 'Initials': 'SN', 'LastName': 'Mehta', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Viral N', 'Initials': 'VN', 'LastName': 'Shah', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Department of Research, Iowa Diabetes Research, West Des Moines, IA.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'Department of Medicine, SUNY Upstate Medical University, Syracuse, NY.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'MacLeish', 'Affiliation': ""Department of Pediatrics, University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital, Cleveland, OH.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'DeSalvo', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Jones', 'Affiliation': 'Department of Research, East Coast Institute for Research at The Jones Center, Macon, GA.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Aleppo', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Endocrinology, Stanford University, Stanford, CA.'}, {'ForeName': 'Trang T', 'Initials': 'TT', 'LastName': 'Ly', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc21-0172']
1395,34097943,Miniaturized Ambulatory Percutaneous Nephrolithotomy Versus Flexible Ureteroscopy in the Management of Lower Calyceal Renal Stones 10-20 mm: A Propensity Score Matching Analysis.,"OBJECTIVE


To evaluate the efficacy of ambulatory mini percutaneous nephrolithotomy (Mini-PCNL) and flexible ureteroscope (F-URS) in treating 10-20 mm lower calyceal stones using propensity score matching analysis (PSM).
PATIENTS AND METHODS


A retrospective analysis of 136 adult patients that underwent Mini-PCNL or F-URS for a single lower calyx calculus. Participants that underwent F-URS were allocated to Group I, while those who underwent Mini-PCNL were assigned to Group II. Patients were discharged on the same day and followed up by CT after 3 months. Both groups were matched by stone size and density using propensity stone matching (PSM) and the matched group were further compared.
RESULTS


Before matching, there were statistical differences in stone size (P = .02), preoperative hydronephrosis (P = .004), and Hounsfield Unit (P = .04) between both groups. A logistic regression model was created between independent variables such as stone size and density. The new groups following PSM were statistically similar in terms of age, BMI, stone size, and HFU (P = .43, P = .74, P = .49, P = .36). The stone-free rates after PSM was not significantly higher in the Mini-PCNL group than the F-URS group (91.7% vs 81.7%, respectively P = .1) while the operative time for the F-URS group was significantly shorter than the Mini-PCNL group 54 (49-64.3) minutes vs 68.2 (62-73.5) minutes, respectively, P = .045.
CONCLUSION


Ambulatory Mini-PCNL and F-URS have a comparable hospital stay, stone-free rates, and complication rates for treating lower calyceal stones 10-20 mm. Both techniques may be considered acceptable treatment options, with a prolonged operative time in Mini-PCNL.",2021,"The SFR after PSM was not significantly higher in the Mini-PCNL group than the F-URS group (91.7% vs. 81.7%, respectively p=0.1) while the operative time for the F-URS group was significantly shorter than the Mini-PCNL group 54(49-64.3) min vs. 68.2(62-73.5) min, respectively, p=0.045.
","['Participants that underwent F-URS', '136 adult patients that underwent Mini-PCNL or F-URS for a single lower calyx calculus']","['Mini-PCNL', 'Ambulatory Mini-PCNL and F-URS', 'Miniaturized Ambulatory Percutaneous Nephrolithotomy versus Flexible Ureteroscopy', 'ambulatory mini percutaneous nephrolithotomy (Mini-PCNL) and flexible ureteroscope (F-URS']","['SFR after PSM', 'age, BMI, stone size, and HFU', 'stone size', 'hospital stay, SFR, and complication rates', 'operative time', 'preoperative hydronephrosis']","[{'cui': 'C0392306', 'cui_str': 'Flexible ureteroscope'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022651', 'cui_str': 'Renal calyx'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0392306', 'cui_str': 'Flexible ureteroscope'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C1841679', 'cui_str': 'Hand-foot-genital syndrome'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}]",136.0,0.115872,"The SFR after PSM was not significantly higher in the Mini-PCNL group than the F-URS group (91.7% vs. 81.7%, respectively p=0.1) while the operative time for the F-URS group was significantly shorter than the Mini-PCNL group 54(49-64.3) min vs. 68.2(62-73.5) min, respectively, p=0.045.
","[{'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Shabana', 'Affiliation': 'Urology Department, Northern Ontario School of Medicine, Thunder bay, Ontario, Canada.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Oquendo', 'Affiliation': 'Urology Department, Northern Ontario School of Medicine, Thunder bay, Ontario, Canada.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Hodhod', 'Affiliation': 'Urology Department, Northern Ontario School of Medicine, Thunder bay, Ontario, Canada.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'Urology Department, Northern Ontario School of Medicine, Thunder bay, Ontario, Canada.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Alaref', 'Affiliation': 'Radiology Departmet, Northern Ontario School of Medicine, Thuder Bay, Ontario, Canada.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Trigo', 'Affiliation': 'Urology Department, Northern Ontario School of Medicine, Thunder bay, Ontario, Canada.'}, {'ForeName': 'Ruba Abdul', 'Initials': 'RA', 'LastName': 'Hadi', 'Affiliation': 'Urology Department, Northern Ontario School of Medicine, Thunder bay, Ontario, Canada.'}, {'ForeName': 'Hani H', 'Initials': 'HH', 'LastName': 'Nour', 'Affiliation': 'Department of Urology, Theodor Bilharz Research Institute, Giza, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Kotb', 'Affiliation': 'Urology Department, Northern Ontario School of Medicine, Thunder bay, Ontario, Canada.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Shahrour', 'Affiliation': 'Urology Department, Northern Ontario School of Medicine, Thunder bay, Ontario, Canada.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Elmansy', 'Affiliation': 'Urology Department, Northern Ontario School of Medicine, Thunder bay, Ontario, Canada. Electronic address: hazem.mansy@rocketmail.com.'}]",Urology,['10.1016/j.urology.2021.05.041']
1396,34101496,Randomized Study on Dose Escalation in Definitive Chemoradiation for Patients With Locally Advanced Esophageal Cancer (ARTDECO Study).,"PURPOSE


To analyze the effect of radiation dose escalation to the primary tumor on local tumor control in definitive chemoradiation (dCRT) for patients with esophageal cancer.
PATIENTS AND METHODS


Patients with medically inoperable and/or irresectable esophageal carcinoma, referred for dCRT, were randomly assigned between a standard dose (SD) of 50.4 Gy/1.8 Gy for 5.5 weeks to the tumor and regional lymph nodes and a high dose (HD) up to a total dose of 61.6 Gy to the primary tumor. Chemotherapy consisted of courses of concurrent carboplatin (area under the curve 2) and paclitaxel (50 mg/m 2 ) in both arms once a week for 6 weeks. The primary end point was local progression-free survival.
RESULTS


Between September 2012 and June 2018, 260 patients were included. Squamous cell carcinoma (SCC) was present in 61% of patients, and 39% had adenocarcinoma (AC). Radiation treatment was completed by 94%, and 85% had at least five courses of chemotherapy. The median follow-up time for all patients was 50 months. The 3-year local progression-free survival (LPFS) was 70% in the SD arm versus 73% in the HD arm (not significant). The LPFS for SCC and AC was 75% versus 79% and 61% versus 61% for SD and HD, respectively (not significant). The 3-year locoregional progression-free survival was 52% and 59% for the SD and HD arms, respectively ( P  = .08). Overall, grade 4 and 5 common toxicity criteria were 12% and 5% in the SD arm versus 14% and 10% in the HD arm, respectively ( P  = .15).
CONCLUSION


In dCRT for esophageal cancer, radiation dose escalation up to 61.6 Gy to the primary tumor did not result in a significant increase in local control over 50.4 Gy. The absence of a dose effect was observed in both AC and SCC.",2021,"The 3-year locoregional progression-free survival was 52% and 59% for the SD and HD arms, respectively ( P  = .08).","['Patients', 'Patients with medically inoperable and/or irresectable esophageal carcinoma, referred for dCRT', 'Between September 2012 and June 2018, 260 patients were included', 'patients with esophageal cancer', 'Squamous cell carcinoma (SCC) was present in 61% of patients, and 39% had adenocarcinoma (AC']","['definitive chemoradiation (dCRT', 'concurrent carboplatin', 'paclitaxel']","['local control', 'local progression-free survival', '3-year locoregional progression-free survival', '3-year local progression-free survival (LPFS', 'Overall, grade 4 and 5 common toxicity criteria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0152018', 'cui_str': 'Carcinoma of esophagus'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}]",260.0,0.156758,"The 3-year locoregional progression-free survival was 52% and 59% for the SD and HD arms, respectively ( P  = .08).","[{'ForeName': 'Maarten C C M', 'Initials': 'MCCM', 'LastName': 'Hulshof', 'Affiliation': 'Department of Radiotherapy, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Elisabeth D', 'Initials': 'ED', 'LastName': 'Geijsen', 'Affiliation': 'Department of Radiotherapy, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Rozema', 'Affiliation': 'Verbeeten Institute, Tilburg, the Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Oppedijk', 'Affiliation': 'Radiotherapeutisch Instituut Friesland, Leeuwarden, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Buijsen', 'Affiliation': 'Department of Radiation Oncology, School for Oncology and Developmental Biology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Neelis', 'Affiliation': 'Leids Universitair Medisch Centrum, Leiden, the Netherlands.'}, {'ForeName': 'Joost J M E', 'Initials': 'JJME', 'LastName': 'Nuyttens', 'Affiliation': 'Department of Radiotherapy, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Maurice J C', 'Initials': 'MJC', 'LastName': 'van der Sangen', 'Affiliation': 'Department of Radiotherapy, Catharina Ziekenhuis, Eindhoven, the Netherlands.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Jeene', 'Affiliation': 'Radiotherapiegroep, Deventer, the Netherlands.'}, {'ForeName': 'Jannie G', 'Initials': 'JG', 'LastName': 'Reinders', 'Affiliation': 'Department of Radiotherapy, Zeeuws Radiotherapeutisch Instituut, Vlissingen, the Netherlands.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Thano', 'Affiliation': 'Department of Biostatistic, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeanin E', 'Initials': 'JE', 'LastName': 'van Hooft', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Hanneke W M', 'Initials': 'HWM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Ate', 'Initials': 'A', 'LastName': 'van der Gaast', 'Affiliation': 'Department of Medical Oncology, Erasmus MC, Rotterdam, the Netherlands.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.03697']
1397,34103538,Effect of metformin versus placebo on metabolic factors in the MA.32 randomized breast cancer trial.,"Metformin may exert anticancer effects through indirect (mediated by metabolic changes) or direct mechanisms. The goal was to examine metformin impact on metabolic factors in non-diabetic subjects and determine whether this impact varies by baseline BMI, insulin, and rs11212617 SNP in CCTG MA.32, a double-blind placebo-controlled randomized adjuvant breast cancer (BC) trial. 3649 subjects with T1-3, N0-3, M0 BC were randomized; pretreatment and 6-month on-treatment fasting plasma was centrally assayed for insulin, leptin, highly sensitive C-reactive protein (hsCRP). Glucose was measured locally and homeostasis model assessment (HOMA) calculated. Genomic DNA was analyzed for the rs11212617 SNP. Absolute and relative change of metabolic factors (metformin versus placebo) were compared using Wilcoxon rank and t-tests. Regression models were adjusted for baseline differences and assessed interactions with baseline BMI, insulin, and the SNP. Mean age was 52 years. The majority had T2/3, node positive, hormone receptor positive, HER2 negative BC treated with (neo)adjuvant chemotherapy and hormone therapy. Median baseline body mass index (BMI) was 27.4 kg/m 2  (metformin) and 27.3 kg/m 2  (placebo). Median weight change was -1.4 kg (metformin) vs +0.5 kg (placebo). Significant improvements were seen in all metabolic factors, with 6 month standardized ratios (metformin/placebo) of 0.85 (insulin), 0.83 (HOMA), 0.80 (leptin), and 0.84 (hsCRP), with no qualitative interactions with baseline BMI or insulin. Changes did not differ by rs11212617 allele. Metformin (vs placebo) led to significant improvements in weight and metabolic factors; these changes did not differ by rs11212617 allele status.",2021,"Significant improvements were seen in all metabolic factors, with 6 month standardized ratios (metformin/placebo) of 0.85 (insulin), 0.83 (HOMA), 0.80 (leptin), and 0.84 (hsCRP), with no qualitative interactions with baseline BMI or insulin.","['3649 subjects with T1-3, N0-3, M0 BC', 'Mean age was 52 years', 'non-diabetic subjects']","['metformin', 'Metformin', 'Metformin (vs placebo', 'metformin versus placebo', 'placebo']","['Genomic DNA', 'weight and metabolic factors', 'metabolic factors', 'Median baseline body mass index (BMI', 'Median weight change']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",3649.0,0.449194,"Significant improvements were seen in all metabolic factors, with 6 month standardized ratios (metformin/placebo) of 0.85 (insulin), 0.83 (HOMA), 0.80 (leptin), and 0.84 (hsCRP), with no qualitative interactions with baseline BMI or insulin.","[{'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Goodwin', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, and Department of Medicine, University of Toronto, Toronto, ON, Canada. Pamela.Goodwin@sinaihealthsystem.ca.'}, {'ForeName': 'Ryan J O', 'Initials': 'RJO', 'LastName': 'Dowling', 'Affiliation': 'Hoffman-La Roche Limited, Mississauga, ON, Canada.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Ennis', 'Affiliation': 'Applied Statistician, Markham, ON, Canada.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Wendy R', 'Initials': 'WR', 'LastName': 'Parulekar', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Shepherd', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Margot J', 'Initials': 'MJ', 'LastName': 'Burnell', 'Affiliation': 'Department of Oncology, Saint John Regional Hospital, St. John, NB, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Vander Meer', 'Affiliation': 'Department of Oncology, Niagara Health System, St. Catharines, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Molckovsky', 'Affiliation': 'Department of Medical Oncology, Grand River Regional Cancer Centre, Kitchener, ON, Canada.'}, {'ForeName': 'Anagha', 'Initials': 'A', 'LastName': 'Gurjal', 'Affiliation': 'Abbotsford Centre, British Columbia Cancer Agency, Abbotsford, BC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'University of British Columbia, BC Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, Columbia, NY, USA.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'McMaster University, Juravinski Cancer Centre, Hamilton, ON, Canada.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Hobday', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NRG Oncology and University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Rabaglio-Poretti', 'Affiliation': 'IBCSG and Department of Oncology, Bern University Hospital, University of Bern, Berne, Switzerland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lemieux', 'Affiliation': 'CHU de Québec-Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Rea', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Vuk', 'Initials': 'V', 'LastName': 'Stambolic', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.'}]",NPJ breast cancer,['10.1038/s41523-021-00275-z']
1398,34109764,Effect of Upadacitinib on the Pharmacokinetics of Rosuvastatin or Atorvastatin in Healthy Subjects.,"This phase 1, 2-part, 2-period, open-label, drug-drug interaction study evaluated the potential for pharmacokinetic interactions between upadacitinib and rosuvastatin, an organic anion transporting polypeptide (OATP) 1B1 and breast cancer resistance protein substrate, or atorvastatin, a cytochrome P450 3A, OATP1B1, and OATP1B3 substrate, in 36 healthy volunteers. During period 1, a single dose of rosuvastatin (5 mg; part 1) or atorvastatin (10 mg; part 2) was administered on day 1, followed by a washout period of 5 days. During period 2, once-daily doses of upadacitinib extended-release (30 mg) were administered on days 1 to 10, and a single dose of rosuvastatin (5 mg; part 1) or atorvastatin (10 mg; part 2) was administered 1 hour after the upadacitinib dose on day 7. Serial blood samples were collected for assays of drug concentrations. In Part 1, rosuvastatin maximum observed plasma concentration (C max  ) and area under the plasma concentration-time curve from time 0 to infinity (AUC inf  ) were 23% and 33% lower, respectively, when administered with upadacitinib relative to when administered alone. In part 2, atorvastatin C max  and AUC inf  was 11% and 23% lower, respectively, when administered with upadacitinib relative to when administered alone. The C max  and AUC inf  of the active metabolite ortho-hydroxyatorvastatin remained unchanged. Administration of a single 5-mg dose of rosuvastatin or a single 10-mg dose of atorvastatin had no relevant effect on upadacitinib C max  or area under the plasma concentration-time curve. These results demonstrated that upadacitinib has no clinically relevant effect on the pharmacokinetics of rosuvastatin and atorvastatin or on substrates transported by OATP1B or breast cancer resistance protein.",2021,The C max  and AUC inf  of the active metabolite ortho-hydroxyatorvastatin remained unchanged.,"['Healthy Subjects', '36 healthy volunteers']","['rosuvastatin and atorvastatin', 'atorvastatin', 'Rosuvastatin or Atorvastatin', 'rosuvastatin']","['atorvastatin C max  and AUC inf', 'C max  and AUC inf  of the active metabolite ortho-hydroxyatorvastatin', 'plasma concentration (C max  ) and area under the plasma concentration-time curve', 'upadacitinib C max  or area under the plasma concentration-time curve']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1870242', 'cui_str': '2-hydroxyatorvastatin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}]",36.0,0.0584708,The C max  and AUC inf  of the active metabolite ortho-hydroxyatorvastatin remained unchanged.,"[{'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Coppola', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Camp', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.957']
1399,34108192,Aqueous chlorhexidine 1% versus 2% for neonatal skin antisepsis: a randomised non-inferiority trial.,"OBJECTIVE


To evaluate whether 1% aqueous chlorhexidine gluconate (CHG) when compared with 2% aqueous chlorhexidine gluconate is non-inferior for neonatal skin antisepsis.
DESIGN


Parallel, blinded, non-inferiority randomised trial.
SETTING


Level III, academic, neonatal intensive care unit.
PATIENTS


Infants born at 26 0/7  to 42 6/7  weeks of gestation from June 2019 to December 2019.
INTERVENTIONS


Participants were randomised to skin antisepsis by either 1% aqueous CHG or 2% aqueous CHG.
MAIN OUTCOME MEASURES


The primary outcome was the proportion of negative skin swab cultures after skin antisepsis. Secondary outcomes were local skin reactions at 0, 6, 12 and 24 hours and plasma chlorhexidine levels in a subset of the study population.
RESULTS


A total of 308 neonates with a median gestation age of 34 (31-37) weeks and mean birth weight of 2029 g were randomised on 685 occasions (1% CHG: n=341; 2% CHG: n=344). 93.0% of the post-antisepsis skin swabs were sterile in 1% CHG group compared with 95.6% of the swabs in the 2% CHG group (risk difference -2.7%, 95% CI -6.2% to +0.8%). The lower bound of 95% CI crossed the pre-specified absolute non-inferiority limit of 5%. Neonates developed mild dermatitis on 16 (2.3%) occasions. There was no significant difference in median plasma CHG levels in the two groups, 19.6 (12.5-36.4) and 12.6 (8.7-26.6) ng/mL, respectively.
CONCLUSIONS


Application of 1% aqueous CHG was not shown to be non-inferior to 2% chlorhexidine aqueous for skin antisepsis in neonates. There were no severe skin-related adverse events in either of the two groups.
TRIAL REGISTRATION NUMBER


CTRI/2019/06/019822; (http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=33453&EncHid=&userName=CTRI/2019/06/019822).",2021,"There were no severe skin-related adverse events in either of the two groups.
","['Infants born at 26 0/7  to 42 6/7  weeks of gestation from June 2019 to December 2019', 'Level III, academic, neonatal intensive care unit', 'neonatal skin antisepsis', 'neonates', '308 neonates with a median gestation age of 34 (31-37) weeks and mean birth weight of 2029\u2009g']","['chlorhexidine gluconate (CHG', 'chlorhexidine', 'chlorhexidine gluconate', 'skin antisepsis by either 1% aqueous CHG or 2% aqueous CHG', 'Aqueous chlorhexidine']","['median plasma CHG levels', 'mild dermatitis', 'local skin reactions at 0, 6, 12 and 24 hours and plasma chlorhexidine levels', 'severe skin-related adverse events', 'proportion of negative skin swab cultures']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]","[{'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0444102', 'cui_str': 'Skin swab'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]",308.0,0.45867,"There were no severe skin-related adverse events in either of the two groups.
","[{'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Srikant', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Thukral', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'M Jeeva', 'Initials': 'MJ', 'LastName': 'Sankar', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India ra.aiims@gmail.com.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Deorari', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Mohapatra', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Thirumurthy', 'Initials': 'T', 'LastName': 'Velpandian', 'Affiliation': 'Department of Ocular Pharmacology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Minu', 'Initials': 'M', 'LastName': 'Bajpai', 'Affiliation': 'Department of Pediatric Surgery, All India Institute of Medical Sciences, New Delhi, India.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2020-321174']
1400,34106974,Integrating a problem-solving intervention with routine care to improve psychosocial functioning among mothers of children with sickle cell disease: A randomized controlled trial.,"OBJECTIVE


To assess the feasibility of a problem-solving skills training intervention in improving psychological outcomes in mothers of infants with sickle cell disease (SCD).
DESIGN AND METHODS


This parallel randomized controlled trial recruited 64 babies with SCD, 6 to 12 months of age, and their mothers. Baseline measurements assessed mothers' coping and problem-solving skills, depression, and parental stress before random assignment to intervention or control groups (n = 32 each). Problem-solving skills intervention was delivered through 6 monthly sessions, when babies attended for routine penicillin prophylaxis. All measurements were repeated for both groups at the end of the intervention period. Intention to treat analysis used repeated measures mixed models with the restricted estimation maximum likelihood approach.
RESULTS


The problem-solving intervention had no significant effect on mothers' problem-solving skills (adjusted treatment effect: -1.69 points (95% CI:-5.62 to 2.25)), coping behaviours (adjusted treatment effect: 0.65 points (95% CI:- -7.13 to 8.41)) or depressive symptoms (adjusted treatment effect: -0.41 (95% CI: -6.00 to 5.19)). It reduced mothers' level of difficulty in managing stressful events by 9.5 points (95% CI (-16.86 to -2.16); effect size: 0.21 SD). In the subgroup of mothers at risk of depression (n = 31 at baseline), the intervention reduced depression scores with treatment effect of 10.4 points (95%CI: -18.83 to -1.88; effect size: 0.67 SD).
CONCLUSION


This problem-solving skills intervention study suggests feasibility and possible efficacy in improving some maternal outcomes. Further refinement and culturally appropriate adaptations of the intervention could lead to stronger effects.",2021,"The problem-solving intervention had no significant effect on mothers' problem-solving skills (adjusted treatment effect: -1.69 points (95% CI:-5.62 to 2.25)), coping behaviours (adjusted treatment effect: 0.65 points (95% CI:- -7.13 to 8.41)) or depressive symptoms (adjusted treatment effect: -0.41 (95% CI: -6.00 to 5.19)).","['64 babies with SCD, 6 to 12 months of age, and their mothers', 'mothers of infants with sickle cell disease (SCD', 'mothers of children with sickle cell disease']","['problem-solving skills training intervention', 'problem-solving intervention with routine care', 'Problem-solving skills intervention']","[""mothers' problem-solving skills"", 'psychosocial functioning', 'coping behaviours', 'depressive symptoms', ""mothers' coping and problem-solving skills, depression, and parental stress"", 'depression scores', 'psychological outcomes']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",64.0,0.165327,"The problem-solving intervention had no significant effect on mothers' problem-solving skills (adjusted treatment effect: -1.69 points (95% CI:-5.62 to 2.25)), coping behaviours (adjusted treatment effect: 0.65 points (95% CI:- -7.13 to 8.41)) or depressive symptoms (adjusted treatment effect: -0.41 (95% CI: -6.00 to 5.19)).","[{'ForeName': 'Monika R', 'Initials': 'MR', 'LastName': 'Asnani', 'Affiliation': 'Caribbean Institute for Health Research, The University of the West Indies, Kingston, Jamaica.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Francis', 'Affiliation': 'School of Health and Human Performance, Georgia College, Milledgeville, Georgia, United States of America.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Knight-Madden', 'Affiliation': 'Caribbean Institute for Health Research, The University of the West Indies, Kingston, Jamaica.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chang-Lopez', 'Affiliation': 'Caribbean Institute for Health Research, The University of the West Indies, Kingston, Jamaica.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'King', 'Affiliation': 'Caribbean Institute for Health Research, The University of the West Indies, Kingston, Jamaica.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Caribbean Institute for Health Research, The University of the West Indies, Kingston, Jamaica.'}]",PloS one,['10.1371/journal.pone.0252513']
1401,34114522,Could the Valsalva manoeuvre be an alternative to the tenaculum for intrauterine device insertion?,"OBJECTIVES


This study investigated whether the Valsalva manoeuvre (VM) could be an alternative to use of the tenaculum for intrauterine device (IUD) insertion. The aims were to establish whether VM could provide good patient comfort and enable the insertion to be performed successfully with adequate pain control in cases where the cervix could not be passed spontaneously.
METHODS


Women who attended the outpatient clinic of Alanya Education and Research Hospital between November 2017 and December 2020 for IUD insertion were randomly assigned to the VM ( n  = 52) or tenaculum ( n  = 55) group. Insertion in the latter group was carried out by grasping the cervix with a single-toothed tenaculum. In the VM group, no tenaculum was used to grasp the cervix; instead, the woman was asked to perform VM during insertion.
RESULTS


IUD insertion success rates were similar between the groups. Procedural anxiety scores were slightly higher in the tenaculum group. Pain scores measured during the procedure were significantly higher in the tenaculum group compared with the VM group. Severe pain was reported by 58.2% of women in the tenaculum group, whereas 57.7% of women in the VM group reported no pain.
CONCLUSION


In cases where an IUD cannot be passed through the cervical canal spontaneously, the procedure should be attempted using VM before using a tenaculum. The use of VM may lead to lower pain and anxiety levels as well as increased patient comfort.",2021,Pain scores measured during the procedure were significantly higher in the tenaculum group compared with the VM group.,['Women who attended the outpatient clinic of Alanya Education and Research Hospital between November 2017 and December 2020 for IUD insertion'],"['Valsalva manoeuvre (VM', 'VM ( n \u2009=\u200952) or tenaculum']","['pain and anxiety levels', 'Severe pain', 'Pain scores', 'IUD insertion success rates', 'pain', 'Procedural anxiety scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0042293', 'cui_str': 'Valsalva maneuver'}, {'cui': 'C0180964', 'cui_str': 'Tenaculum'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0365573,Pain scores measured during the procedure were significantly higher in the tenaculum group compared with the VM group.,"[{'ForeName': 'Meral Tugba', 'Initials': 'MT', 'LastName': 'Cimsir', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Alaaddin Keykubat University, Alanya, Turkey.'}, {'ForeName': 'Muhammet Serhat', 'Initials': 'MS', 'LastName': 'Yildiz', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alanya Education and Research Hospital, Alanya, Turkey.'}]",The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception,['10.1080/13625187.2021.1934442']
1402,34111193,"Investigating contributors to performance evaluations in small groups: Task competence, speaking time, physical expressiveness, and likability.","This study compared the impacts of actual individual task competence, speaking time and physical expressiveness as indicators of verbal and nonverbal communication behavior, and likability on performance evaluations in a group task. 164 participants who were assigned to 41 groups first solved a problem individually and later solved it as a team. After the group interaction, participants' performance was evaluated by both their team members and qualified external observers. We found that these performance evaluations were significantly affected not only by task competence but even more by speaking time and nonverbal physical expressiveness. Likability also explained additional variance in performance evaluations. The implications of these findings are discussed for both the people being evaluated and the people doing the evaluating.",2021,We found that these performance evaluations were significantly affected not only by task competence but even more by speaking time and nonverbal physical expressiveness.,['164 participants who were assigned to 41 groups first solved a problem individually and later solved it as a team'],[],"['actual individual task competence, speaking time and physical expressiveness as indicators of verbal and nonverbal communication behavior, and likability on performance evaluations', 'speaking time and nonverbal physical expressiveness']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0028325', 'cui_str': 'Nonverbal Communication'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",164.0,0.0311492,We found that these performance evaluations were significantly affected not only by task competence but even more by speaking time and nonverbal physical expressiveness.,"[{'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Nikoleizig', 'Affiliation': 'University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Stefan C', 'Initials': 'SC', 'LastName': 'Schmukle', 'Affiliation': 'University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Maurin', 'Initials': 'M', 'LastName': 'Griebenow', 'Affiliation': 'University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'University of Leipzig, Leipzig, Germany.'}]",PloS one,['10.1371/journal.pone.0252980']
1403,34111160,No benefit for elbow blocking on conservative treatment of distal radius fractures: A 6-month randomized controlled trial.,"PURPOSE


For displaced distal radius fracture, this trial aimed to compare an above-elbow (AE) and below-elbow (BE) cast at the end of a 24-week follow-up using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire as a primary outcome.
METHODS


This is a clinical trial with parallel groups (1:1) and a blinded evaluator. There are two non-surgical interventions: AE and BE. A total of 128 adult patients with acute (up to 7 days) displaced distal radius fracture of type A2-3, C1-3 by the AO classification were included. The follow-up was 24 weeks. The primary outcome was the DASH questionnaire at 24 weeks. Secondary outcomes were the maintenance of reduction by the evaluation of radiographic parameters, pain measured by VAS, PRWE, objective functional evaluation and rate of adverse effects.
RESULTS


The difference between the two groups in the DASH score at 24 weeks was not significant, with the mean (95% CI) DASH score being AE: 9.44 (2.70 to 16.17) vs. BE: 9.88 (3.19 to 16.57) (p = 0.895). The above-elbow group had a significantly greater worsening of the mean DASH score from baseline to 2 weeks (p < 0.001). No statistically significant differences were found between the 2 groups in any of the other follow-up assessments. Objective functional evaluation, PRWE, radiographical measures and rates of reduction loss were similar between groups. Above-elbow casting resulted in more adverse effects (mostly shoulder pain; 19 events vs. 9 events); RR = 0.39 (0.19-0.94); p = 0.033 at the end of six-month follow-up.
CONCLUSIONS


This study did not demonstrate a difference between above-elbow and below-elbow cast in terms of DASH outcome at 6 months in non-surgical treatment of deviated distal radius fractures. However, below-elbow casting is less debilitating during the treatment period, has comparable performance in maintaining the reduction, and is related to fewer minor adverse effects than above-elbow casting.",2021,This study did not demonstrate a difference between above-elbow and below-elbow cast in terms of DASH outcome at 6 months in non-surgical treatment of deviated distal radius fractures.,"['distal radius fractures', '128 adult patients with acute (up to 7 days) displaced distal radius fracture of type A2-3, C1-3 by the AO classification were included']",['elbow blocking'],"['maintenance of reduction by the evaluation of radiographic parameters, pain measured by VAS, PRWE, objective functional evaluation and rate of adverse effects', 'DASH questionnaire', 'adverse effects', 'Objective functional evaluation, PRWE, radiographical measures and rates of reduction loss', 'mean DASH score', 'DASH score']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",128.0,0.240928,This study did not demonstrate a difference between above-elbow and below-elbow cast in terms of DASH outcome at 6 months in non-surgical treatment of deviated distal radius fractures.,"[{'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Okamura', 'Affiliation': 'Department of Orthopaedics and Traumatology, Unit of Hand Surgery, Universidade Federal de São Paulo (Unifesp -EPM), São Paulo, Brazil.'}, {'ForeName': 'Vinícius Ynoe', 'Initials': 'VY', 'LastName': 'de Moraes', 'Affiliation': 'Department of Orthopaedics and Traumatology, Unit of Hand Surgery, Universidade Federal de São Paulo (Unifesp -EPM), São Paulo, Brazil.'}, {'ForeName': 'Jorge Raduan', 'Initials': 'JR', 'LastName': 'Neto', 'Affiliation': 'Department of Orthopaedics and Traumatology, Unit of Hand Surgery, Universidade Federal de São Paulo (Unifesp -EPM), São Paulo, Brazil.'}, {'ForeName': 'Marcel Jun', 'Initials': 'MJ', 'LastName': 'Tamaoki', 'Affiliation': 'Department of Orthopaedics and Traumatology, Unit of Hand Surgery, Universidade Federal de São Paulo (Unifesp -EPM), São Paulo, Brazil.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Faloppa', 'Affiliation': 'Department of Orthopaedics and Traumatology, Unit of Hand Surgery, Universidade Federal de São Paulo (Unifesp -EPM), São Paulo, Brazil.'}, {'ForeName': 'João Carlos', 'Initials': 'JC', 'LastName': 'Belloti', 'Affiliation': 'Department of Orthopaedics and Traumatology, Unit of Hand Surgery, Universidade Federal de São Paulo (Unifesp -EPM), São Paulo, Brazil.'}]",PloS one,['10.1371/journal.pone.0252667']
1404,34111152,A randomized controlled trial comparing non-steroidal anti-inflammatory and fusion protein inhibitors singly and in combination on the histopathology of bovine respiratory syncytial virus infection.,"Bovine respiratory syncytial virus (RSV) has substantial morbidity in young calves, and closely parallels human RSV in infants. We performed a randomized controlled trial in five to six-week-old Holstein calves (Bos taurus). comparing fusion protein inhibitor (FPI) and non-steroidal anti-inflammatory drug (NSAID) singly and in combination at three and five days after experimental BRSV infection. Thirty-six calves received one of six treatments; Ibuprofen started on day 3, Ibuprofen started on day 5, FPI started on day 5, FPI and Ibuprofen started on day 3, FPI and Ibuprofen started on day 5, or placebo. We have previously reported significant clinical benefits when combined FPI and NSAID treatment was started at three and five days after bovine RSV infection. Necropsy was performed on Day 10 following infection and hematoxylin and eosin staining was performed on sections from each lobe. Histology was described using a four-point scale. We performed canonical discrimination analysis (CDA) to determine the structural level where differences between treatments occurred and mixed effects regression to estimate effect sizes. Separation from placebo was maximal for dual therapy at the levels of the alveolus, septum, and bronchus in CDA. We found that the clinical benefits of combined FPI and NSAID treatment of BRSV extend at least partially from histopathological changes in the lung when treatment was started three days after infection. We found decreased lung injury when ibuprofen was started as monotherapy on day 3, but not day 5 following infection. Combined therapy with both an FPI and ibuprofen was always better than ibuprofen alone. We did not prove that the clinical benefits seen starting FPI and ibuprofen five days after infection can be solely explained by histopathological differences as identified on H&E staining.",2021,"Separation from placebo was maximal for dual therapy at the levels of the alveolus, septum, and bronchus in CDA.","['bovine respiratory syncytial virus infection', 'Thirty-six calves', 'young calves', 'five to six-week-old Holstein calves (Bos taurus']","['ibuprofen', 'fusion protein inhibitor (FPI) and non-steroidal anti-inflammatory drug (NSAID', 'Ibuprofen started on day 5, FPI started on day 5, FPI and Ibuprofen started on day 3, FPI and Ibuprofen started on day 5, or placebo', 'Bovine respiratory syncytial virus (RSV', 'Ibuprofen', 'FPI and ibuprofen', 'placebo', 'steroidal anti-inflammatory and fusion protein inhibitors singly and in combination']",['lung injury'],"[{'cui': 'C0206544', 'cui_str': 'Bovine respiratory syncytial virus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0206544', 'cui_str': 'Bovine respiratory syncytial virus'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0273115', 'cui_str': 'Injury of lung'}]",,0.234666,"Separation from placebo was maximal for dual therapy at the levels of the alveolus, septum, and bronchus in CDA.","[{'ForeName': 'Francisco R', 'Initials': 'FR', 'LastName': 'Carvallo Chaigneau', 'Affiliation': 'Division of Veterinary Pathology, Department of Biomedical Sciences & Pathobiology Virginia Tech, Blacksburg, VA, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Walsh', 'Affiliation': 'Pediatric Emergency Medicine, The Sutter Medical Center Sacramento, Sacramento, CA, United States of America.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Lebedev', 'Affiliation': 'Dept. of Pathology, Microbiology & Immunology, School of Veterinary Medicine, University of California, Davis, Davis, CA, United States of America.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Mutua', 'Affiliation': 'Dept. of Pathology, Microbiology & Immunology, School of Veterinary Medicine, University of California, Davis, Davis, CA, United States of America.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McEligot', 'Affiliation': 'Dept. of Pathology, Microbiology & Immunology, School of Veterinary Medicine, University of California, Davis, Davis, CA, United States of America.'}, {'ForeName': 'Heejung', 'Initials': 'H', 'LastName': 'Bang', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of California Davis, Davis, CA, United States of America.'}, {'ForeName': 'Laurel J', 'Initials': 'LJ', 'LastName': 'Gershwin', 'Affiliation': 'Dept. of Pathology, Microbiology & Immunology, School of Veterinary Medicine, University of California, Davis, Davis, CA, United States of America.'}]",PloS one,['10.1371/journal.pone.0252455']
1405,34455111,The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain.,"Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical trial entitled OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness). OPTIMUM is offered online via telehealth and includes medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR for persons with cLBP. In diverse health-care settings in the US, such as a safety net hospital, federally qualified health centers, and a large academic health system, 450 patients will be assigned randomly to the MGV + MBSR or to usual PCP care alone. Participants will complete self-report surveys at baseline, following the 8-week program, and at 6- and 12-month follow-up. Health care utilization data will be obtained through electronic health records and via brief monthly surveys completed by participants. The primary outcome measure is the PEG (Pain, enjoyment, and general activity) at the 6-month follow-up. Additionally, we will assess psychological function, healthcare resource use, and opioid prescriptions. This trial, which is part of the NIH HEAL Initiative, has the potential to enhance primary care treatment of cLBP by combining PCP visits with a non-pharmacological treatment modeled on MBSR. Because it is offered online and integrated into primary care, it is expected to be scalable and accessible to underserved patients. Clinical Trials.gov: NCT04129450.",2021,"Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics.","['persons with chronic low back pain', '450 patients', 'Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients', 'persons with cLBP', 'underserved patients']","['Telehealth group mindfulness program', 'Mindfulness-based stress reduction (MBSR']","['PEG (Pain, enjoyment, and general activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0441655', 'cui_str': 'Activity'}]",450.0,0.131325,"Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics.","[{'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Greco', 'Affiliation': 'Department of Psychiatry and Physical Therapy, University of Pittsburgh School of Medicine and School of Health and Rehabilitation Sciences, PA, United States of America.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Gaylord', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Faurot', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Weinberg', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, MA, United States of America.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Gardiner', 'Affiliation': 'Department of Family Medicine and Community Health, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Roth', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Barnhill', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Holly N', 'Initials': 'HN', 'LastName': 'Thomas', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, PA, United States of America.'}, {'ForeName': 'Sayali C', 'Initials': 'SC', 'LastName': 'Dhamne', 'Affiliation': 'Boston University School of Public Health, Boston Medical Center, MA, United States of America.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lathren', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Jose E', 'Initials': 'JE', 'LastName': 'Baez', 'Affiliation': 'General Internal Medicine, Boston Medical Center, MA, United States of America.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lawrence', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, PA, United States of America.'}, {'ForeName': 'Tuhina', 'Initials': 'T', 'LastName': 'Neogi', 'Affiliation': 'Section of Rheumatology, Department of Medicine, Boston University School of Medicine, United States of America.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, Boston Medical Center, Boston University School of Medicine, Boston, MA, United States of America.'}, {'ForeName': 'Maria Gabriela', 'Initials': 'MG', 'LastName': 'Castro', 'Affiliation': 'Siler City Community Health Center, Piedmont Health Services, Department of Family Medicine, University of North Carolina at Chapel Hill, NC, United States of America.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'White', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, PA, United States of America.'}, {'ForeName': 'Sandra Jean', 'Initials': 'SJ', 'LastName': 'Simmons', 'Affiliation': 'Private practice, Raleigh, NC, United States of America.'}, {'ForeName': 'Cleopatra', 'Initials': 'C', 'LastName': 'Ferrao', 'Affiliation': 'General Internal Medicine, Boston Medical Center, MA, United States of America.'}, {'ForeName': 'Dhanesh D', 'Initials': 'DD', 'LastName': 'Binda', 'Affiliation': 'Boston University School of Medicine, Boston, MA, United States of America.'}, {'ForeName': 'Nandie', 'Initials': 'N', 'LastName': 'Elhadidy', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Eason', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McTigue', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, PA, United States of America.'}, {'ForeName': 'Natalia E', 'Initials': 'NE', 'LastName': 'Morone', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, Boston Medical Center, Boston University School of Medicine, Boston, MA, United States of America. Electronic address: natalia.morone@bmc.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106545']
1406,34459659,"Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial.","BACKGROUND


Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with nonvalvular atrial fibrillation. The Amulet IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman device.
METHODS


Patients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device. The primary end points included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and the rate of LAA occlusion at 45 days. Prespecified secondary end points included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the 3 primary end points.
RESULTS


A total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety end point (14.5% versus 14.7%; difference=-0.14 [95% CI, -3.42 to 3.13];  P <0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% versus 10.0% and 3.9% versus 5.1%, respectively). Procedure-related complications were higher for the Amulet occluder (4.5% versus 2.5%), largely related to more frequent pericardial effusion and device embolization. The Amulet occluder was noninferior to the Watchman device for the primary effectiveness end point (2.8% versus 2.8%; difference=0.00 [95% CI, -1.55 to 1.55];  P <0.001 for noninferiority), and the composite of stroke, systemic embolism, or cardiovascular/unexplained death (5.6% versus 7.7%, difference=-2.12 [95% CI, -4.45 to 0.21];  P <0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% versus 12.3%; difference=-0.71 [95% CI, -3.72 to 2.31];  P =0.32 for superiority). LAA occlusion was higher for the Amulet occluder than for the Watchman device (98.9% versus 96.8%; difference=2.03 [95% CI, 0.41-3.66];  P <0.001 for noninferiority;  P =0.003 for superiority).
CONCLUSIONS


The Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular atrial fibrillation compared with the Watchman device and superior for LAA occlusion. Procedure-related complications were higher with the Amulet occluder and decreased with operator experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02879448.",2021,"The Amulet occluder was non-inferior for safety and effectiveness of stroke prevention for NVAF compared with the Watchman device, and superior for LAA occlusion.","['patients with non-valvular atrial fibrillation (NVAF', 'Patients with NVAF at increased risk of stroke', '1878 patients were enrolled']","['URL', ':  Percutaneous closure of the left atrial appendage (LAA', 'percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device']","['safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months) and effectiveness (composite of ischemic stroke or systemic embolism at 18 months) and the rate of LAA occlusion', 'LAA occlusion', 'safety and effectiveness', 'Procedure-related complications', 'Major bleeding and all-cause death', 'rate of major bleeding', 'composite of stroke, systemic embolism or cardiovascular/unexplained death', 'composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0225832', 'cui_str': 'Structure of auricular appendage'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0335390', 'cui_str': 'Watchman'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0277589', 'cui_str': 'Death of unknown cause'}]",1878.0,0.351319,"The Amulet occluder was non-inferior for safety and effectiveness of stroke prevention for NVAF compared with the Watchman device, and superior for LAA occlusion.","[{'ForeName': 'Dhanunjaya', 'Initials': 'D', 'LastName': 'Lakkireddy', 'Affiliation': 'Kansas City Heart Rhythm Institute and Research Foundation, Overland Park (D.L.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thaler', 'Affiliation': 'Tufts Medical Center, Boston, MA (D.T.).'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Ellis', 'Affiliation': 'Vanderbilt Heart Institute, Nashville, TN (C.R.E).'}, {'ForeName': 'Vijendra', 'Initials': 'V', 'LastName': 'Swarup', 'Affiliation': 'Arizona Cardiovascular Research Center, Phoenix (V.S.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Sondergaard', 'Affiliation': 'Righospitalet, Copenhagen, Denmark (L.S.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'University of Colorado Hospital, Anschultz Medical Campus, Aurora (J.C.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Gold', 'Affiliation': 'Medical University of South Carolina, Charleston (M.R.G.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hermiller', 'Affiliation': 'St. Vincent Medical Group Inc, Indianapolis, IN (J.H.).'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'University Duisburg-Essen, Germany (H.-C.D.).'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Schmidt', 'Affiliation': 'Cardioangiologisches Centrum Bethanien, Frankfurt, Germany (B.S.).'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'MacDonald', 'Affiliation': 'South Denver Cardiology Associates P.C., Littleton, CO (L.M.).'}, {'ForeName': 'Moussa', 'Initials': 'M', 'LastName': 'Mansour', 'Affiliation': 'Massachusetts General Hospital, Boston (M.M.).'}, {'ForeName': 'Brijeshwar', 'Initials': 'B', 'LastName': 'Maini', 'Affiliation': 'Delray Medical Center, FL (B.M.).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': ""O'Brien"", 'Affiliation': 'Abbott Structural Heart, Plymouth, MN (L.O.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Inselspital, University of Bern, Switzerland (S.W.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.057063']
1407,34098331,"10% Lidocaine spray as a local anesthetic in blood gas sampling: A randomized, double-blind, placebo-controlled study.","AIM


Radial artery blood gas sampling is a very common procedure undertaken in the emergency department to evaluate respiratory and metabolic parameters. This intervention causes both anxiety and pain for the patient. Therefore, the current study aimed to examine the analgesic efficacy of lidocaine spray compared to a placebo during radial artery blood gas sampling.
METHODS


This study was conducted in the emergency department of a tertiary hospital with a randomized, double-blind, placebo-controlled design. A total of 144 patients were randomly divided into two groups: One group (n = 72) received 10% lidocaine spray and the other (n = 72) was the placebo group. The analgesic efficacy of the 10% lidocaine spray was compared with the placebo group using the Visual Analog Scale (VAS).
RESULTS


In the evaluation of the analgesic efficacy of the 10% lidocaine spray, the VAS score was 1.5 [interquartile range (IQR): 2.0] for the lidocaine group and 5 (IQR: 2.0) for the placebo group. The role of lidocaine spray in reducing pain was statistically significant compared to the placebo (p = 0.000).
CONCLUSION


In blood gas sampling, 10% lidocaine spray has analgesic efficacy. Therefore, we recommend the use of lidocaine spray while performing arterial blood gas sampling in emergency departments.",2021,"The role of lidocaine spray in reducing pain was statistically significant compared to the placebo (p = 0.000).
","['emergency department of a tertiary hospital', '144 patients']","['lidocaine spray', 'lidocaine', 'Lidocaine spray', 'Radial artery blood gas sampling', 'placebo']","['analgesic efficacy', 'VAS score', 'anxiety and pain', 'blood gas sampling', 'pain', 'Visual Analog Scale (VAS']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",144.0,0.371424,"The role of lidocaine spray in reducing pain was statistically significant compared to the placebo (p = 0.000).
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Gur', 'Affiliation': 'Ataturk University School of Medicine, Clinical Research, Development and Design Application and Research Center, Erzurum, Turkey; Department of Emergency, School of Medicine, Ataturk University, Erzurum, Turkey. Electronic address: aligur@atauni.edu.tr.'}, {'ForeName': 'Erdal', 'Initials': 'E', 'LastName': 'Tekin', 'Affiliation': 'Department of Emergency, School of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.05.060']
1408,34110925,Children's Oncology Group Phase III Trial of Reduced-Dose and Reduced-Volume Radiotherapy With Chemotherapy for Newly Diagnosed Average-Risk Medulloblastoma.,"PURPOSE


Children with average-risk medulloblastoma (MB) experience survival rates of ≥ 80% at the expense of adverse consequences of treatment. Efforts to mitigate these effects include deintensification of craniospinal irradiation (CSI) dose and volume.
METHODS


ACNS0331 (ClinicalTrials.gov identifier: NCT00085735) randomly assigned patients age 3-21 years with average-risk MB to receive posterior fossa radiation therapy (PFRT) or involved field radiation therapy (IFRT) following CSI. Young children (3-7 years) were also randomly assigned to receive standard-dose CSI (SDCSI; 23.4 Gy) or low-dose CSI (LDCSI; 18 Gy). Post hoc molecular classification and mutational analysis contextualized outcomes according to known biologic subgroups (Wingless, Sonic Hedgehog, group 3, and group 4) and genetic biomarkers. Neurocognitive changes and ototoxicity were monitored over time.
RESULTS


Five hundred forty-nine patients were enrolled on study, of which 464 were eligible and evaluable to compare PFRT versus IFRT and 226 for SDCSI versus LDCSI. The five-year event-free survival (EFS) was 82.5% (95% CI, 77.2 to 87.8) and 80.5% (95% CI, 75.2 to 85.8) for the IFRT and PFRT regimens, respectively, and 71.4% (95% CI, 62.8 to 80) and 82.9% (95% CI, 75.6 to 90.2) for the LDCSI and SDCSI regimens, respectively. IFRT was not inferior to PFRT (hazard ratio, 0.97; 94% upper CI, 1.32). LDCSI was inferior to SDCSI (hazard ratio, 1.67%; 80% upper CI, 2.10). Improved EFS was observed in patients with Sonic Hedgehog MB who were randomly assigned to the IFRT arm ( P  = .018). Patients with group 4 MB receiving LDCSI exhibited inferior EFS ( P  = .047). Children receiving SDCSI exhibited greater late declines in IQ (estimate = 5.87;  P  = .021).
CONCLUSION


Reducing the radiation boost volume in average-risk MB is safe and does not compromise survival. Reducing CSI dose in young children with average-risk MB results in inferior outcomes, possibly in a subgroup-dependent manner, but is associated with better neurocognitive outcome. Molecularly informed patient selection warrants further exploration for children with MB to be considered for late-effect sparing approaches.",2021,"Children receiving SDCSI exhibited greater late declines in IQ (estimate = 5.87;  P  = .021).
","['Five hundred forty-nine patients were enrolled on study, of which 464 were eligible and evaluable to compare', 'randomly assigned patients age 3-21 years with average-risk MB to receive', 'patients with Sonic Hedgehog MB', 'Young children (3-7 years']","['Reduced-Dose and Reduced-Volume Radiotherapy With Chemotherapy', 'standard-dose CSI (SDCSI; 23.4 Gy) or low-dose CSI', 'PFRT versus IFRT', 'posterior fossa radiation therapy (PFRT) or involved field radiation therapy (IFRT) following CSI', 'IFRT']","['average-risk medulloblastoma (MB) experience survival rates', 'Improved EFS', 'five-year event-free survival (EFS', 'Neurocognitive changes and ototoxicity']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0025149', 'cui_str': 'Medulloblastoma'}, {'cui': 'C0018866', 'cui_str': 'Erinaceidae'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3494227', 'cui_str': 'Spinocranial Irradiation'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0325079', 'cui_str': 'Cryptoprocta ferox'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0025149', 'cui_str': 'Medulloblastoma'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0235280', 'cui_str': 'Ototoxicity'}]",549.0,0.15037,"Children receiving SDCSI exhibited greater late declines in IQ (estimate = 5.87;  P  = .021).
","[{'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Michalski', 'Affiliation': 'Department of Radiation Oncology, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Anna J', 'Initials': 'AJ', 'LastName': 'Janss', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'L Gilbert', 'Initials': 'LG', 'LastName': 'Vezina', 'Affiliation': ""Division of Diagnostic Imaging and Radiology, Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Kyle S', 'Initials': 'KS', 'LastName': 'Smith', 'Affiliation': ""Department of Developmental Neurobiology, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Billups', 'Affiliation': ""Department of Biostatistics, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Burger', 'Affiliation': 'Department of Neuropathology, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Embry', 'Affiliation': 'Department of Pediatrics, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Cullen', 'Affiliation': 'Loretto Heights School of Nursing, Regis University, Denver, CO.'}, {'ForeName': 'Kristina K', 'Initials': 'KK', 'LastName': 'Hardy', 'Affiliation': ""Division of Neuropsychology, Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Pomeroy', 'Affiliation': 'Department of Neurology, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Johnnie K', 'Initials': 'JK', 'LastName': 'Bass', 'Affiliation': ""Department of Rehabilitation Services, St Jude's Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Perkins', 'Affiliation': 'Department of Radiation Oncology, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Merchant', 'Affiliation': ""Department of Radiation Oncology, St Jude's Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Colte', 'Affiliation': ""Division of Hematology/Oncology/BMT, Primary Children's Hospital, Aurora, CO.""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Fitzgerald', 'Affiliation': 'Image and Radiation Oncology Core-Rhode Island, Lincoln, RI.'}, {'ForeName': 'Timothy N', 'Initials': 'TN', 'LastName': 'Booth', 'Affiliation': 'Department of Radiology, UT Southwestern/Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Cherlow', 'Affiliation': ""Department of Radiation Oncology, Miller Children's and Women's Hospital Long Beach, Long Beach, CA.""}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Muraszko', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hadley', 'Affiliation': ""Department of Developmental Neurobiology, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ""Department of Developmental Neurobiology, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Biostatistics, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Tarbell', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Fouladi', 'Affiliation': 'Department of Pediatrics, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Ian F', 'Initials': 'IF', 'LastName': 'Pollack', 'Affiliation': ""Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, PA.""}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Packer', 'Affiliation': ""Center for Neuroscience and Behavioral Medicine, Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Yimei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Biostatistics, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Gajjar', 'Affiliation': ""Department of Oncology, St Jude's Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Northcott', 'Affiliation': ""Department of Developmental Neurobiology, St Jude Children's Research Hospital, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02730']
1409,34115959,Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial.,"Background:  Closed-loop control (CLC) has been shown to improve glucose time in range and other glucose metrics; however, randomized trials >3 months comparing CLC with sensor-augmented pump (SAP) therapy are limited. We recently reported glucose control outcomes from the 6-month international Diabetes Closed-Loop (iDCL) trial; we now report patient-reported outcomes (PROs) in this iDCL trial.  Methods:  Participants were randomized 2:1 to CLC ( N  = 112) versus SAP ( N  = 56) and completed questionnaires, including Hypoglycemia Fear Survey, Diabetes Distress Scale (DDS), Hypoglycemia Awareness, Hypoglycemia Confidence, Hyperglycemia Avoidance, and Positive Expectancies of CLC (INSPIRE) at baseline, 3, and 6 months. CLC participants also completed Diabetes Technology Expectations and Acceptance and System Usability Scale (SUS).  Results:  The Hypoglycemia Fear Survey Behavior subscale improved significantly after 6 months of CLC compared with SAP. DDS did not differ except for powerless subscale scores, which worsened at 3 months in SAP. Whereas Hypoglycemia Awareness and Hyperglycemia Avoidance did not differ between groups, CLC participants showed a tendency toward improved confidence in managing hypoglycemia. The INSPIRE questionnaire showed favorable scores in the CLC group for teens and parents, with a similar trend for adults. At baseline and 6 months, CLC participants had high positive expectations for the device with Diabetes Technology Acceptance and SUS showing high benefit and low burden scores.  Conclusion:  CLC improved some PROs compared with SAP. Participants reported high benefit and low burden with CLC. Clinical Trial Identifier: NCT03563313.",2021,"Whereas Hypoglycemia Awareness and Hyperglycemia Avoidance did not differ between groups, CLC participants showed a tendency towards improved confidence in managing hypoglycemia.",['Participants'],"['SAP', 'CLC with sensor-augmented pump (SAP) therapy', 'CLC', 'Closed-Loop Control', 'Closed-Loop Control (CLC']","['Diabetes Technology Expectations and Acceptance and System Usability Scales (SUS', 'Hypoglycemia Fear Survey Behavior subscale', 'Hypoglycemia Fear Survey, Diabetes Distress Scale (DDS), Hypoglycemia Awareness, Hypoglycemia Confidence, Hyperglycemia Avoidance, and Positive Expectancies of CLC (INSPIRE', 'powerless subscale scores', 'confidence in managing hypoglycemia', 'Hypoglycemia Awareness and Hyperglycemia Avoidance']",[],"[{'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]",,0.324411,"Whereas Hypoglycemia Awareness and Hyperglycemia Avoidance did not differ between groups, CLC participants showed a tendency towards improved confidence in managing hypoglycemia.","[{'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': 'University of Virginia Center for Diabetes Technology, Charlottesville, Virginia, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, California, USA.'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Levy', 'Affiliation': 'Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Laurel H', 'Initials': 'LH', 'LastName': 'Messer', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Boris P', 'Initials': 'BP', 'LastName': 'Kovatchev', 'Affiliation': 'University of Virginia Center for Diabetes Technology, Charlottesville, Virginia, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Lum', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gonder-Frederick', 'Affiliation': 'University of Virginia Center for Diabetes Technology, Charlottesville, Virginia, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes technology & therapeutics,['10.1089/dia.2021.0089']
1410,34433114,Mental imagery-based episodic simulation amplifies motivation and behavioural engagement in planned reward activities.,"Preliminary evidence suggests mental imagery-based episodic simulation of planned reward activities may amplify motivation and promote greater behavioural engagement, particularly for activities with high motivational barriers (Renner, Murphy, Ji, Manly, & Holmes, 2019). This study conducted a conceptual replication and extension of Renner et al. (2019). N = 81 first-year university students self-selected and scheduled two reward activities (one hedonic, one mastery) for the following week before being randomly allocated to either an Imagery-Experiential elaboration condition (n = 27), a Verbal-Reasoning elaboration condition (n = 28), or a Scheduling-only Control condition (n = 26). Following the lab session, all participants received standardized daily prompts to complete daily activity diaries online for seven days. The Imagery-Experiential condition reported greater increases in anticipatory pleasure (state mood), anticipated pleasure, and self-reported motivation compared to the Scheduling-only Control condition, and greater increases in anticipatory pleasure (state mood), but not anticipated pleasure or motivation, relative to the Verbal-Reasoning condition. Consistent with Renner et al. (2019), the Imagery-Experiential condition, but not the Verbal-Reasoning condition, reported more frequent engagement in high motivational barrier activities than the Scheduling-only Control condition. Exploratory mediational analyses suggested that mental imagery may exert unique motivational impacts via its impact on anticipatory pleasure (state mood), although indirect effects were only observed for self-reported motivation change in the lab, with real world behavioural effects falling short of statistical significance.",2021,"The Imagery-Experiential condition reported greater increases in anticipatory pleasure (state mood), anticipated pleasure, and self-reported motivation compared to the Scheduling-only Control condition, and greater increases in anticipatory pleasure (state mood), but not anticipated pleasure or motivation, relative to the Verbal-Reasoning condition.","['N\xa0=\xa081 first-year university students self-selected and scheduled two reward activities (one hedonic, one mastery']","['Mental imagery-based episodic simulation', 'Imagery-Experiential elaboration condition (n\xa0=\xa027), a Verbal-Reasoning elaboration condition (n\xa0=\xa028), or a Scheduling-only Control condition']","['anticipatory pleasure (state mood', 'frequent engagement in high motivational barrier activities', 'pleasure or motivation, relative to the Verbal-Reasoning condition', 'anticipatory pleasure (state mood), anticipated pleasure, and self-reported motivation']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.0201437,"The Imagery-Experiential condition reported greater increases in anticipatory pleasure (state mood), anticipated pleasure, and self-reported motivation compared to the Scheduling-only Control condition, and greater increases in anticipatory pleasure (state mood), but not anticipated pleasure or motivation, relative to the Verbal-Reasoning condition.","[{'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Ji', 'Affiliation': 'School of Psychological Science, University of Western Australia, Australia. Electronic address: julie.ji@uwa.edu.au.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Geiles', 'Affiliation': 'School of Psychological Science, University of Western Australia, Australia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Saulsman', 'Affiliation': 'School of Psychological Science, University of Western Australia, Australia.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103947']
1411,34448856,Facilitators and barriers to implementing lifestyle intervention programme to prevent cognitive decline.,"BACKGROUND


The Finnish Intervention Study to Prevent Cognitive Impairment and Disability is a randomized controlled trial that has tested the efficacy of a multidomain intervention targeting modifiable risk factors to prevent cognitive impairment/dementia. A combination of healthy diet, physical, social and cognitive activity, and management of cardiovascular risks was shown to be an effective model to promote brain health among older people. The aim of this qualitative study was to explore healthcare professionals' perceptions of facilitators and barriers to implementing this lifestyle programme into health care.
METHODS


Four semi-structured focus group interviews were conducted among healthcare professionals working in primary care and in non-governmental organizations (N=27). Participants were asked to discuss their perceptions of facilitators and barriers for implementing the multidomain intervention into clinical practice. Interviews were analyzed using content analysis.
RESULTS


Barriers and facilitators described by the healthcare professionals were related to infrastructure and resources, client's personal characteristics and the lifestyle intervention itself. These main categories included several sub-categories related to knowledge, motivation, resources, individualization and collaboration. The interviewees pointed out that more education on dementia prevention is needed, the work should be coordinated efficiently, resources to provide preventive health care should be adequate and multiprofessional collaboration is needed.
CONCLUSIONS


Transferring a lifestyle intervention from a trial-setting to real life requires knowledge about the factors that influence effective implementation. Identifying drivers and constraints of successful implementation helps to design and tailor future prevention programmes, increases motivation and adherence and supports system change.",2021,"Identifying drivers and constraints of successful implementation helps to design and tailor future prevention programmes, increases motivation and adherence and supports system change.",['older people'],"['implementing lifestyle intervention programme', 'multidomain intervention', 'healthcare professionals working in primary care and in non-governmental organizations']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0282271', 'cui_str': 'Nongovernmental Organizations'}]",[],,0.0265926,"Identifying drivers and constraints of successful implementation helps to design and tailor future prevention programmes, increases motivation and adherence and supports system change.","[{'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Kulmala', 'Affiliation': 'Faculty of Social Sciences (Health Sciences) and Gerontology Research Center (GEREC), Tampere University, Tampere, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosenberg', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Ngandu', 'Affiliation': 'Department of Public Health and Welfare, Population Health Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Hemiö', 'Affiliation': 'Department of Public Health and Welfare, Population Health Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Tenkula', 'Affiliation': 'Southern Ostrobothnia Central Hospital, Seinäjoki, Finland.'}, {'ForeName': 'Arja', 'Initials': 'A', 'LastName': 'Hyytiä', 'Affiliation': 'Southern Ostrobothnia Central Hospital, Seinäjoki, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Vienola', 'Affiliation': 'Härmä Rehabilitation Center, Ylihärmä, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Huhtamäki-Kuoppala', 'Affiliation': 'South Ostrobothnia Memory Association, Ylihärmä, Finland.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Saarinen', 'Affiliation': 'City of Seinäjoki, Finland.'}, {'ForeName': 'Saana', 'Initials': 'S', 'LastName': 'Korkki', 'Affiliation': 'Department of Psychology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Department of Public Health and Welfare, Population Health Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Department of Public Health and Welfare, Population Health Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}]",European journal of public health,['10.1093/eurpub/ckab087']
1412,34450326,A flexible sample size solution for longitudinal and crossover cluster randomized trials with continuous outcomes.,"Longitudinal cluster randomized trial (LCRT) and crossover cluster randomized trial (CCRT) are two variants of cluster randomized trials. In LCRTs, clusters of subjects are randomly assigned to different treatment groups and each subject has repeated measurements over the study period. In CCRTs, clusters of subjects are randomly assigned to different sequences. Within each sequence, clusters receive all treatments in a particular order. Both LCRTs and CCRTs lead to complicated correlation structures that involve longitudinal and intracluster correlations. Generalized linear mixed model (GLMM) and generalized estimating equation (GEE) approaches have been frequently employed in data analysis and sample size estimation. In this study we propose closed-form sample size and power formulas for LCRTs and CCRTs based on the GEE approach. These formulas are flexible to incorporate unbalanced randomization, different missing patterns, arbitrary correlation structures, and randomly varying cluster sizes, providing a practical yet robust sample size solution. Simulation studies show that the proposed methods achieve good performance with empirical powers and type I errors close to their nominal values.",2021,Simulation studies show that the proposed methods achieve good performance with empirical powers and type I errors close to their nominal values.,[],['Generalized linear mixed model (GLMM) and generalized estimating equation (GEE'],[],[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",[],,0.0945997,Simulation studies show that the proposed methods achieve good performance with empirical powers and type I errors close to their nominal values.,"[{'ForeName': 'Jijia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Applied Clinical Research, UT Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Statistical Science, Southern Methodist University, Dallas, TX, United States of America.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Population and Data Sciences, UT Southwestern Medical Center, Dallas, TX, United States of America. Electronic address: song.zhang@utsouthwestern.edu.'}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Department of Population and Data Sciences, UT Southwestern Medical Center, Dallas, TX, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106543']
1413,34450277,"Regarding ""Optimal Dose of Pituitrin in Laparoscopic Uterine Myomectomy: A Prospective, Double-Blinded, Randomized Controlled Trial"".",,2021,,['Laparoscopic Uterine Myomectomy'],['Pituitrin'],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}]","[{'cui': 'C0032023', 'cui_str': 'Pituitrin'}]",[],,0.896372,,"[{'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2021.08.013']
1414,34454044,"Hydroxychloroquine plus azithromycin early treatment of mild COVID-19 in an outpatient setting: a randomized, double-blinded, placebo-controlled clinical trial evaluating viral clearance.","BACKGROUND


Hydroxychloroquine has shown potential to block viral replication of SARS-CoV-2 in some in vitro studies. This randomised, double-blinded, placebo controlled clinical trial evaluated the efficacy of hydroxychloroquine plus azithromycin (HCQ/AZT) in reducing viral loads in patients with early and mild SARS-CoV-2 infection.
METHODS


A single-centre randomised placebo-controlled clinical trial was conducted with outpatients with early and mild SARS-CoV-2 infection. Inclusion criteria were: patients aged 18-65 years with symptoms suggestive of COVID-19 for < 5 days, no significant comorbidities, and positive nasopharyngeal/oropharyngeal swab screening tests (POCT-PCR). Randomised patients received either hydroxychloroquine for 7 days plus azithromycin for 5 days or placebo. The primary endpoint was viral clearance within a 9-day period. Secondary endpoints included viral load reduction, clinical evolution, hospitalization rates, chest computed tomography evolution, and adverse effects.
RESULTS


From 107 potential trial participants, 84 were enrolled following predetermined criteria. Statistical analyses were performed on an intention-to-treat (N = 84) and per-protocol (PP) basis (N = 70). On the PP analysis, the treatment (N = 36) and placebo (N = 34) groups displayed similar demographic characteristics. At 95% CI, no statistically significant between-group differences were found in viral clearance rates within 9 days following enrolment (P = 0.26).
CONCLUSIONS


This randomised, double-blinded, placebo-controlled clinical trial evaluating outpatients with early and mild COVID-19 showed that viral clearance rates within a 9-day period from enrolment did not change with HCQ/AZT treatment compared with placebo, although no major cardiovascular events were observed in participants without comorbidities. Secondary outcomes were also not significantly improved with HCQ/AZT treatment compared with placebo. These findings do not support use of HCQ/AZT in this setting.",2021,These findings do not support use of HCQ,"['patients with early and mild SARS-CoV-2 infection', 'outpatients with early and mild COVID-19, the use of HCQ', 'patients aged between 18 to 65 years with symptoms suggestive of COVID-19 for fewer than five days, no significant comorbidities, and positive naso/oropharyngeal swab screening tests (POCT-PCR', 'From 107 potential trial participants, 84 were enrolled following pre-determined criteria', 'mild COVID-19 in outpatient setting', 'outpatients with early and mild SARS-CoV-2 infection was conducted']","['Hydroxychloroquine plus azithromycin', 'azithromycin', 'Hydroxychloroquine', 'hydroxychloroquine plus azithromycin', 'placebo', 'HCQ', 'hydroxychloroquine']","['viral clearance', 'time to viral clearance', 'viral clearance rates', 'viral loads', 'viral load reduction, clinical evolution, hospitalization rates, chest computed tomography evolution and adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0074744', 'cui_str': 'sodium metabisulfite'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",84.0,0.869387,These findings do not support use of HCQ,"[{'ForeName': 'Cristhieni', 'Initials': 'C', 'LastName': 'Rodrigues', 'Affiliation': 'Hospital Infection Control Committee, Hospital Santa Paula, Ímpar Serviços Hospitalares S.A., São Paulo, São Paulo, Brazil. Electronic address: cristhieni@uol.com.br.'}, {'ForeName': 'Rodrigo S', 'Initials': 'RS', 'LastName': 'Freitas-Santos', 'Affiliation': 'Institute for Education and Research, Hospital Santa Paula, Ímpar Serviços Hospitalares S.A., São Paulo, São Paulo, Brazil. Electronic address: rodrigo.santos@santapaula.com.br.'}, {'ForeName': 'José Eduardo', 'Initials': 'JE', 'LastName': 'Levi', 'Affiliation': 'Research and Development Department, Diagnósticos da América S.A. (Dasa), Brazil.'}, {'ForeName': 'Andreza A', 'Initials': 'AA', 'LastName': 'Senerchia', 'Affiliation': 'Clinical Research Department, Diagnósticos da América S.A. (Dasa), Brazil.'}, {'ForeName': 'Ana Tarina A', 'Initials': 'ATA', 'LastName': 'Lopes', 'Affiliation': 'Institute for Education and Research, Hospital Santa Paula, Ímpar Serviços Hospitalares S.A., São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sergio R', 'Initials': 'SR', 'LastName': 'Santos', 'Affiliation': 'Strategy Board, Diagnósticos da América S.A. (Dasa), Brazil.'}, {'ForeName': 'Rinaldo F', 'Initials': 'RF', 'LastName': 'Siciliano', 'Affiliation': 'Heart Institute (InCor), Medical School, Universidade de São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lígia C', 'Initials': 'LC', 'LastName': 'Pierrotti', 'Affiliation': 'Infectious Diseases Division, Hospital das Clínicas, Universidade de São Paulo, São Paulo, São Paulo, Brazil; Infectious Diseases Department, Diagnósticos da América S.A. (Dasa), Brazil.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2021.106428']
1415,34456060,"A Phase I, Open-label, Randomized, 2-Way Crossover Study to Evaluate the Relative Bioavailability of Intranasal and Oral Varenicline.","PURPOSE


To estimate the systemic bioavailability of OC-01 (varenicline) nasal spray, an investigational treatment for dry eye disease, relative to oral varenicline approved for smoking cessation.
METHODS


The Study to Evaluate the Relative Bioavailability of Varenicline Administered as OC-01 (Varenicline) Nasal Spray as Compared to Varenicline Administered Orally as Chantix (ZEN study) was a Phase I, open-label, randomized, single-center, 2-way crossover study. On day 1, 22 healthy participants were randomized 1:1 to a single intranasal dose of varenicline 0.12 mg in OC-01 nasal spray or a single oral dose of varenicline 1 mg. On day 15, all participants crossed over to receive a single dose of the alternate treatment. Plasma samples were collected for 6 days after each dose, and pharmacokinetic parameters were estimated using noncompartmental analysis. Tolerability was monitored throughout.
FINDINGS


After a single dose of intranasal varenicline 0.12 mg in OC-01 nasal spray, peak systemic exposure (mean plasma C max ) was 0.34 ng/mL, which occurred at a median T max  of 2.0 hours. In comparison, mean plasma C max  after oral varenicline 1 mg was 4.63 ng/mL at a median T max  of 3.0 hours. On the basis of geometric mean ratio point estimates, peak exposure (C max ) and total exposure (AUC 0-∞ ) after intranasal varenicline 0.12 mg were 7.0% and 7.5%, respectively, of the systemic exposure associated with oral varenicline 1 mg. Dose-normalized C max  and AUC 0-∞  for intranasal varenicline remained 39% and 33% lower versus oral varenicline, respectively. No new or unexpected tolerability signals were detected.
IMPLICATIONS


At its highest intended single dose in OC-01 nasal spray, intranasal varenicline delivered less drug to the systemic circulation than oral varenicline at its highest approved single dose. ClinicalTrials.gov identifier: NCT04072146.",2021,"Dose-normalized C max  and AUC 0-∞  for intranasal varenicline remained 39% and 33% lower versus oral varenicline, respectively.",['22 healthy participants'],"['Varenicline', 'varenicline 0.12 mg in OC-01 nasal spray or a single oral dose of varenicline 1 mg', 'varenicline', 'Intranasal and Oral Varenicline', 'intranasal varenicline', 'Varenicline Administered as OC-01 (Varenicline) Nasal Spray', 'OC-01 (varenicline) nasal spray']","['geometric mean ratio point estimates, peak exposure (C max ) and total exposure (AUC 0-∞ ', 'Tolerability', 'mean plasma C max', 'peak systemic exposure (mean plasma C max ']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1711888', 'cui_str': 'varenicline 1 MG'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",22.0,0.0790185,"Dose-normalized C max  and AUC 0-∞  for intranasal varenicline remained 39% and 33% lower versus oral varenicline, respectively.","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Nau', 'Affiliation': 'Oyster Point Pharma, Inc., Princeton, New Jersey. Electronic address: jnau@oysterpointrx.com.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Wyatt', 'Affiliation': 'Syneos Health, Inc., Morrisville, North Carolina.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Rollema', 'Affiliation': 'Rollema Biomedical Consulting, Mystic, Connecticut.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Crean', 'Affiliation': 'Xyzagen, Inc., Pittsboro, Connecticut.'}]",Clinical therapeutics,['10.1016/j.clinthera.2021.07.020']
1416,34455583,First-in-Human Study of Bamlanivimab in a Randomized Trial of Hospitalized Patients With COVID-19.,"Therapeutics for patients hospitalized with coronavirus disease 2019 (COVID-19) are urgently needed during the pandemic. Bamlanivimab is a potent neutralizing monoclonal antibody that blocks severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) attachment and entry into human cells, which could potentially lead to therapeutic benefit. J2W-MC-PYAA was a randomized, double-blind, sponsor unblinded, placebo-controlled, single ascending dose first-in-human trial (NCT04411628) in hospitalized patients with COVID-19. A total of 24 patients received either placebo or a single dose of bamlanivimab (700 mg, 2,800 mg, or 7,000 mg). The primary objective was assessment of safety and tolerability, including adverse events and serious adverse events, with secondary objectives of pharmacokinetic (PK) and pharmacodynamic analyses. Treatment-emergent adverse event (TEAE) rates were identical in the placebo and pooled bamlanivimab groups (66.7%). There were no apparent dose-related increases in the number or severity of TEAEs. There were no serious adverse events or deaths during the study, and no discontinuations due to adverse events. PKs of bamlanivimab is linear and exposure increased proportionally with dose following single i.v. administration. The half-life was ~ 17 days. These results demonstrate the favorable safety profile of bamlanivimab, and provided the initial critical evaluation of safety, tolerability, and PKs in support of the development of bamlanivimab in several ongoing clinical trials.",2021,"There were no serious adverse events or deaths during the study, and no discontinuations due to adverse events.","['Hospitalized Patients with COVID-19', 'patients hospitalized with COVID-19', 'hospitalized patients with COVID-19']","['bamlanivimab', 'placebo', 'Bamlanivimab']","['Treatment-emergent adverse event (TEAE) rates', 'serious adverse events or deaths', 'safety and tolerability, including adverse events and serious adverse events, with secondary objectives of pharmacokinetic (PK) and pharmacodynamic (PD) analyses', 'number or severity of TEAEs']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",24.0,0.507601,"There were no serious adverse events or deaths during the study, and no discontinuations due to adverse events.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.""}, {'ForeName': 'Gourab', 'Initials': 'G', 'LastName': 'Datta', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Grace Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chien', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Price', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Chigutsa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Brown-Augsburger', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Poorbaugh', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Fill', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Benschop', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Rouphael', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Kay', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Fischer', 'Affiliation': 'The University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dougan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Benson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2405']
1417,34455106,Influence of 35% hydrogen peroxide gel renewal on color change during in-office dental photobleaching with violet LED: A split-mouth randomized controlled clinical trial.,"BACKGROUND


To clinically evaluate the effect of 35% hydrogen peroxide gel renewal in association with violet LED (405-410nm) through a split-mouth randomized controlled clinical trial.
METHODS


The treatment consisted in 3 bleaching sessions of 15 min each, with an interval of 7 days between them, using 35% hydrogen peroxide combined to violet LED irradiation. Selected patients had two experimental segments for the split-mouth design: No change of the bleaching gel during each session (NBGR) and 3 changes of the bleaching gel every 5 min for each session (BGR). During the 3 bleaching sessions, the selected quadrant received the same treatment. Patients had their upper canines and central incisors teeth color measured with a subjective (color scale - VITA Classical) and an objective (spectrophotometer - VITA Easyshade) method and their teeth sensitivity measured using a Visual Analog Scale (VAS) before, immediately after each bleaching session, and 14 days and 2 months (60 days) after the end of the treatment.
RESULTS


The protocol adopted in the present study reached satisfactory results regarding color change. No statistical difference between groups was observed immediately after the end of the treatment and in the follow-up analysis for both subjective and objective color evaluation. No difference in tooth sensitivity between segments was observed.
CONCLUSION


There is no need for bleaching gel renewal when following the clinical protocol of 3 sessions of 15 min in a bleaching protocol of 35% hydrogen peroxide combined with violet LED.",2021,No statistical difference between groups was observed immediately after the end of the treatment and in the follow-up analysis for both subjective and objective color evaluation.,['color change during in-office dental photobleaching with violet LED'],"['bleaching gel', 'hydrogen peroxide combined to violet LED irradiation', '35% hydrogen peroxide gel', '35% hydrogen peroxide gel renewal']","['upper canines and central incisors teeth color measured with a subjective (color scale - VITA Classical) and an objective (spectrophotometer - VITA Easyshade) method and their teeth sensitivity measured using a Visual Analog Scale (VAS', 'tooth sensitivity']","[{'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0405339,No statistical difference between groups was observed immediately after the end of the treatment and in the follow-up analysis for both subjective and objective color evaluation.,"[{'ForeName': 'Shady A', 'Initials': 'SA', 'LastName': 'Youssef', 'Affiliation': 'Universidade Ibirapuera, Av. Interlagos, 1329, São Paulo, SP 04661-100, Brazil.'}, {'ForeName': 'Sandra Ribeiro', 'Initials': 'SR', 'LastName': 'Cunha', 'Affiliation': 'College of Dentistry, University of Iowa, 801 Newton Road, Iowa City, IA, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Mayer-Santos', 'Affiliation': 'Laboratório Especial de Laser em Odontologia (LELO), Universidade de São Paulo, Faculdade de Odontologia, Av. Professor Lineu Prestes, 2227, São Paulo, SP, Brazil.'}, {'ForeName': 'Sara Alves', 'Initials': 'SA', 'LastName': 'Brito', 'Affiliation': 'Universidade Ibirapuera, Av. Interlagos, 1329, São Paulo, SP 04661-100, Brazil.'}, {'ForeName': 'Patrícia Moreira', 'Initials': 'PM', 'LastName': 'de Freitas', 'Affiliation': 'Laboratório Especial de Laser em Odontologia (LELO), Universidade de São Paulo, Faculdade de Odontologia, Av. Professor Lineu Prestes, 2227, São Paulo, SP, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Ramalho', 'Affiliation': 'Universidade Ibirapuera, Av. Interlagos, 1329, São Paulo, SP 04661-100, Brazil.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Morimoto', 'Affiliation': 'Universidade Ibirapuera, Av. Interlagos, 1329, São Paulo, SP 04661-100, Brazil.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Gonçalves', 'Affiliation': 'Universidade Ibirapuera, Av. Interlagos, 1329, São Paulo, SP 04661-100, Brazil.'}, {'ForeName': 'Karen Müller', 'Initials': 'KM', 'LastName': 'Ramalho', 'Affiliation': 'Universidade Ibirapuera, Av. Interlagos, 1329, São Paulo, SP 04661-100, Brazil. Electronic address: karenramalho@hotmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102509']
1418,34110603,Influences of Gender on Intravenous Nalbuphine Actions After Major Abdominal Surgery: A Multicenter Study.,"INTRODUCTION


Nalbuphine, a synthetic kappa-opioid receptor (KOR) agonist and a partial µ-opioid receptor (MOR) antagonist, has been used for years as an effective analgesic. It has been shown to have a better safety profile than morphine. Considering the long history of use of this drug, it is interesting that only a limited amount of information exists on how gender differences influence nalbuphine responses. In this randomized double-blind comparative trial after major abdominal surgery, the analgesic effects of two doses of continuous intravenous infusion of nalbuphine were evaluated based on gender.
METHODS


Enrolled patients were divided into four groups (two females and two males with 32 patients in each group). Two of them (groups A1 and A2), one male and one female, received postoperative continuous intravenous infusions of nalbuphine at 2 mg/h via patient-controlled analgesia (PCA). Each patient had the potential of receiving a rescue bolus of 1 mg of nalbuphine with a lock out time of 15 min. The other two groups (groups B1 and B2) received half the infusion dose, 1 mg/h, and half the nalbuphine rescue dose with the PCA pump, 0.5 mg maximum every 15 min as needed. Patients' vital signs, numerical pain rating scores, rescue nalbuphine, and incidence of side effects were assessed immediately after the operation, and every 3 h during the first 12 h.
RESULTS


Nalbuphine 2 mg/h dosing led to significantly lower pain scores amongst females compared to males at 6, 9, and 12 h; while the 1 mg/h infusion pain scores were only lower at the 9-h time period. Females receiving the nalbuphine 2 mg dose at 6 h, and the 1 mg dose at 6, 9, and 12-h measurements needed significantly lower doses of rescue nalbuphine. Females on the 1 mg dose experienced significantly more nausea, vomiting, and sedation at the 6-, 9-, and 12-h measurement times. In the multivariate analysis, female gender was a negative predictor at all measurement times.
CONCLUSIONS


The current study supports the hypothesis that although nalbuphine was found to be an effective and well-tolerated analgesic after major abdominal surgery, females were statistically more responsive than males.
TRIAL REGISTRATION


The study was registered at the Pan African Clinical trials Registry PACTR201304000486309, and approved for the Ethical aspects.",2021,"Patients' vital signs, numerical pain rating scores, rescue nalbuphine, and incidence of side effects were assessed immediately after the operation, and every 3 h during the first 12 h.
RESULTS


Nalbuphine 2 mg/h dosing led to significantly lower pain scores amongst females compared to males at 6, 9, and 12 h; while the 1 mg/h infusion pain scores were only lower at the 9-h time period.",['Enrolled patients were divided into four groups (two females and two males with 32 patients in each group'],"['nalbuphine', 'nalbuphine rescue dose with the PCA pump', 'Nalbuphine, a synthetic kappa-opioid receptor (KOR) agonist and a partial µ-opioid receptor (MOR) antagonist', 'Nalbuphine Actions', 'postoperative continuous intravenous infusions of nalbuphine at 2\xa0mg/h via patient-controlled analgesia (PCA', 'morphine']","['analgesic effects', 'nausea, vomiting, and sedation', 'infusion pain scores', ""Patients' vital signs, numerical pain rating scores, rescue nalbuphine, and incidence of side effects"", 'effective and well-tolerated analgesic', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0064239', 'cui_str': 'kappa Opioid Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439421', 'cui_str': 'mg/h'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",1.0,0.0536537,"Patients' vital signs, numerical pain rating scores, rescue nalbuphine, and incidence of side effects were assessed immediately after the operation, and every 3 h during the first 12 h.
RESULTS


Nalbuphine 2 mg/h dosing led to significantly lower pain scores amongst females compared to males at 6, 9, and 12 h; while the 1 mg/h infusion pain scores were only lower at the 9-h time period.","[{'ForeName': 'Amany E', 'Initials': 'AE', 'LastName': 'Ayad', 'Affiliation': 'Department of Anesthesia ICU and Pain, Cairo University, Cairo, 11566, Egypt.'}, {'ForeName': 'Ossama H', 'Initials': 'OH', 'LastName': 'Salman', 'Affiliation': 'Department of Anesthesiology, South Valley University, Qena, 83511, Egypt.'}, {'ForeName': 'Ahmed Mokhtar Fathy', 'Initials': 'AMF', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anesthesiology, Assiut University, Assiut, 71515, Egypt.'}, {'ForeName': 'Waleed A M', 'Initials': 'WAM', 'LastName': 'Al-Taher', 'Affiliation': 'Department of Anesthesiology, Ain Shams University, Cairo, 11566, Egypt.'}, {'ForeName': 'Adel M', 'Initials': 'AM', 'LastName': 'Mishriky', 'Affiliation': 'Department of Community Medicine, Suez Canal University, Ismailia, 41511, Egypt.'}, {'ForeName': 'Joseph V', 'Initials': 'JV', 'LastName': 'Pergolizzi', 'Affiliation': 'NEMA Research Group, Research and Development, Naples, FL, 34101, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Viswanath', 'Affiliation': 'Department of Anesthesiology, University of Arizona, Phoenix, AZ, 85003, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Urits', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MS, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rekatsina', 'Affiliation': 'Whipps Cross Hospital, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Peppin', 'Affiliation': 'College of Osteopathic Medicine, Pikeville University, Pikeville, KT, USA.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Paladini', 'Affiliation': ""Department of MESVA, University of L'Aquila, 67100, L'Aquila, Italy.""}, {'ForeName': 'Giustino', 'Initials': 'G', 'LastName': 'Varrassi', 'Affiliation': 'Research and Development, Paolo Procacci Foundation, via Tacito 7, 00193, Rome, Italy. giuvarr@gmail.com.'}]",Pain and therapy,['10.1007/s40122-021-00277-6']
1419,34114012,"Letter to the Editor From Grill et al: ""Islet Function and Insulin Sensitivity in Latent Autoimmune Diabetes in Adults Taking Sitagliptin: A Randomized Trial"".",,2021,,['latent autoimmune diabetes in adults taking sitagliptin'],[],['Islet function and insulin sensitivity'],"[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0443146', 'cui_str': 'Autoimmune reaction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]",[],"[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",,0.147971,,"[{'ForeName': 'Valdemar', 'Initials': 'V', 'LastName': 'Grill', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Björklund', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Hals', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab411']
1420,34116270,Chemotherapy-induced ovarian failure in young women with early breast cancer: Prospective analysis of four randomised neoadjuvant/adjuvant breast cancer trials.,"BACKGROUND


Young women receiving chemotherapy for early breast cancer (EBC) have a high probability for ovarian failure, defined by chemotherapy-induced amenorrhea (CIA) as a surrogate. CIA is insufficiently reliable and reproducible. We analysed chemotherapy-induced ovarian failure (CIOF) by assessing hormone parameters, CIA, and antral follicle count (AFC).
METHODS


Blood samples of women aged ≤45 years treated with anthracycline/taxane-based chemotherapy for EBC from four neoadjuvant/adjuvant trials were collected at baseline, at the end of treatment (EOT), and at 6, 12, 18, and 24 months after EOT. Centrally assessed oestradiol (cutoff <52.2 ng/L) and follicle-stimulating hormone (cutoff >12.4IU/L) were used to define CIOF for patients with baseline premenopausal hormone levels, anti-Müllerian hormone (AMH), and AFC to assess ovarian reserve. Further analyses included CIA, regain of premenopausal hormone levels, and disease-free survival (DFS) also in subgroups.
RESULTS


Six hundred ninety-six patients aged ≤45 years had premenopausal hormone levels at baseline. Overall, 85.1% (592/696) experienced CIOF at EOT, and 147 of 592 had further hormone measurements after EOT. Of those, 32.7% (48/147) regained premenopausal hormone levels after 6 months, 57.9% (66/114) regained premenopausal hormone levels after 12 months, 83.0% (73/88) regained premenopausal hormone levels after 18 months, and 89.2% (74/83) regained premenopausal hormone levels after 24 months. After 24 months, 72.4% (21/29) of patients without CIOF and 100% (14/14) with CIOF had low AMH levels. Four-year DFS without CIOF versus CIOF was 65.9% versus 84.6% (hazard ratio [HR] = 2.09, 95% confidence interval [CI]: 1.37-3.19; P < 0.001); in hormone receptor positive 61.8% versus 87.5% (HR = 2.69, 95% CI: 1.57-4.60; P < 0.001); in <30 years 68.3% versus 92.6% (HR = 4.87, 95% CI: 1.05-22.63; P = 0.026).
CONCLUSION


Most premenopausal women experienced CIOF after chemotherapy for EBC. After 2 years, nearly all regain premenopausal hormone levels. CIOF was associated with better DFS, especially in patients with hormone receptor-positive EBC or aged <30 years.",2021,"CIOF was associated with better DFS, especially in patients with hormone receptor-positive EBC or aged <30 years.","['patients with hormone receptor-positive EBC or aged <30 years', 'Young women receiving chemotherapy for early breast cancer (EBC', 'Six hundred ninety-six patients aged ≤45 years', 'young women with early breast cancer', 'Blood samples of women aged ≤45 years treated with']","['CIA', 'anthracycline/taxane-based chemotherapy for EBC', 'Chemotherapy-induced ovarian failure']","['premenopausal hormone levels', 'CIA, regain of premenopausal hormone levels, and disease-free survival (DFS', 'hormone parameters, CIA, and antral follicle count (AFC', 'low AMH levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0747102', 'cui_str': 'Ovarian failure'}]","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",696.0,0.325359,"CIOF was associated with better DFS, especially in patients with hormone receptor-positive EBC or aged <30 years.","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Furlanetto', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany. Electronic address: Jenny.Furlanetto@gbg.de.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Universitätsfrauenklinik Mannheim, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Seiler', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thode', 'Affiliation': 'Amedes MVZ Wagnerstibbe für Laboratoriumsmedizin, Medizinische Mikrobiologie und Immunologie, Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Kliniken Berlin-Buch, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schmatloch', 'Affiliation': 'Elisabeth Krankenhaus Kassel, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Disease, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bassy', 'Affiliation': 'Amedes MVZ Wagnerstibbe für Laboratoriumsmedizin, Medizinische Mikrobiologie und Immunologie, Göttingen, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen, Germany.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Strik', 'Affiliation': 'Endokrinologikum, Berlin, Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': 'Uniklinik RWTH Aachen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': 'Mammazentrum Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Karn', 'Affiliation': 'Universitätsklinikum Frankfurt, Germany.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': 'Universitätsklinikum Tübingen, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Institut für Pathologie Philipps-Universität Marburg, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'van Mackelenbergh', 'Affiliation': 'Universitätsklinikum Schleswig-Holstein, Klinik für Gynäkologie und Geburtshilfe, Schleswig-Holstein, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Universitätsklinikum Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.04.038']
1421,34432899,A Phase 1 Trial to Evaluate the Relationship Between Fluoride Intake and Urinary Fluoride Excretion in Healthy Participants.,"Chronic overexposure to fluoride can have deleterious effects in the musculoskeletal system. Some fluorine-containing therapeutics, such as voriconazole, release fluoride through metabolism. Therefore, drug-related fluoride exposure should be assessed for novel therapeutics suspected of releasing fluoride through metabolism. Two trials were conducted to identify the optimal method of assessing drug-related fluoride exposure. In trial 1, designed to assess reproducibility of fluoride pharmacokinetics in urine and plasma, 14 participants were administered a fluoride-restricted diet and once-daily doses of sodium fluoride (2.2 mg [1 mg of fluoride] on days 1 and 2; and 13.2 mg of sodium fluoride [6 mg of fluoride] on days 3 and 4). In trial 2, designed to confirm the selected method for fluoride detection, 12 participants were administered a fluoride-restricted diet and randomized to receive voriconazole (400 mg twice, 12 hours apart, on day 1 [131 mg/d of fluoride maximum], then 3 doses of 200 mg every 12 hours [65.3 mg/d of fluoride maximum]) or placebo. Plasma fluoride concentrations and urinary fluoride excretion were assessed in each trial. Assessment of plasma fluoride concentrations in trial 1 was limited by 301 of 854 samples (35.2%) below the lower limit of quantitation. Urine fluoride excretion was readily measured and demonstrated a decrease from baseline during the fluoride-restricted diet phase, as well as dose-proportional increases with fluoride administration. In trial 2, increases in urine fluoride were successfully observed in participants administered voriconazole. In conclusion, fluoride exposure was optimally assessed by urinary fluoride excretion in conjunction with strict dietary fluoride restrictions, as measurements were consistent and reproducible.",2021,"Urine fluoride excretion was readily measured and demonstrated a decrease from baseline during the fluoride-restricted diet phase, as well as dose-proportional increases with fluoride administration.","['12 participants were administered a', 'urine and plasma, 14 participants', 'Healthy Participants']","['fluoride-restricted diet and randomized to receive voriconazole', 'fluoride-restricted diet and once-daily doses of sodium fluoride (2.2 mg [1 mg fluoride', 'placebo', 'sodium fluoride [6 mg fluoride', 'voriconazole']","['Plasma fluoride concentrations and urinary fluoride excretion', 'urine fluoride', 'plasma fluoride concentrations', 'Urine fluoride excretion']","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0042036', 'cui_str': 'Urine'}]",14.0,0.0573416,"Urine fluoride excretion was readily measured and demonstrated a decrease from baseline during the fluoride-restricted diet phase, as well as dose-proportional increases with fluoride administration.","[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Gillespie', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Jackson Rudd', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Saijuan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaeffer', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Tomek', 'Affiliation': 'Celerion, Lincoln, Nebraska, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Larson', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1956']
1422,34435371,"Fluoride Pharmacokinetics in Urine and Plasma Following Multiple Doses of MK-8507, an Investigational, Oral, Once-Weekly Nonnucleoside Reverse Transcriptase Inhibitor.","MK-8507 is an investigational HIV-1 nonnucleoside reverse transcriptase inhibitor being developed for the treatment of HIV-1 infection. MK-8507 contains 2 trifluoromethyl groups that may result in fluoride release through metabolism, but the extent of MK-8507-related fluoride release in humans has yet to be determined. This double-blind, placebo-controlled, 2-period, parallel-group, multiple-dose trial in healthy participants without HIV-1 who were administered a fluoride-restricted diet and once-weekly doses of MK-8507 aimed to estimate the relationship between MK-8507 dose and fluoride exposure. A total of 15 adult male and 3 adult female (of non-childbearing potential) participants were randomized to receive MK-8507 200 mg (n = 6), MK-8507 800 mg (n = 6), or placebo (n = 6). Change from baseline in mean daily fluoride excretion averaged over 7 days following the administration of MK-8507 200 mg resulted in a net mean increase of 19.8 μmol (90% confidence interval, 12.2-27.4) relative to placebo and did not exceed 57 μmol, a threshold related to the mean difference between the daily reference dose set by the US Environmental Protection Agency and the average dietary fluoride intake in the United States. However, daily urinary fluoride excretion exceeded the threshold following administration of 800 mg MK-8507 (75.1 μmol [90% confidence interval, 67.5-82.7]). Assuming a linear relationship between MK-8507 dose and estimated mean daily fluoride released at steady-state, data interpolation suggests that the US Environmental Protection Agency reference dose for fluoride would not be exceeded in most patients when administering MK-8507 at doses currently under clinical investigation (≤400 mg once weekly).",2021,"However, daily urinary fluoride excretion exceeded the threshold following administration of 800 mg MK-8507 (75.1 μmol [90% CI: 67.5, 82.7]).","['Fifteen adult male and 3 adult female (of non-childbearing potential) participants', 'healthy participants without HIV-1 administered a']","['placebo', 'fluoride-restricted diet', 'MK-8507']","['mean daily fluoride excretion', 'daily urinary fluoride excretion']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",15.0,0.161492,"However, daily urinary fluoride excretion exceeded the threshold following administration of 800 mg MK-8507 (75.1 μmol [90% CI: 67.5, 82.7]).","[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Gillespie', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Jackson Rudd', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Saijuan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaeffer', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Tomek', 'Affiliation': 'Celerion, Lincoln, Nebraska, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Larson', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1957']
1423,34440684,Exercise Training Enhances Angiogenesis-Related Gene Responses in Skeletal Muscle of Patients with Chronic Heart Failure.,"Peripheral myopathy consists of a hallmark of heart failure (HF). Exercise enhanced skeletal muscle angiogenesis, and thus, it can be further beneficial towards the HF-induced myopathy. However, there is limited evidence regarding the exercise type that elicits optimum angiogenic responses of skeletal muscle in HF patients. This study aimed to (a) compare the effects of a high-intensity-interval-training (HIIT) or combined HIIT with strength training (COM) exercise protocol on the expression of angiogenesis-related factors in skeletal muscle of HF patients, and (b) examine the potential associations between the expression of those genes and capillarization in the trained muscles. Thirteen male patients with chronic HF (age: 51 ± 13 y; BMI: 27 ± 4 kg/m 2 ) were randomly assigned to a 3-month exercise program that consisted of either HIIT ( N  = 6) or COM training ( N  = 7). Vastus lateralis muscle biopsies were performed pre- and post-training. RT-PCR was used to quantify the fold changes in mRNA expression of vascular endothelial growth factor (VEGF), vascular endothelial growth factor receptor 2 (VEGFR-2), hypoxia-inducible factor 1 alpha (HIF-1α), angiopoietin 1 (Ang-1), angiopoietin 2 (Ang-2), angiopoietin receptor (Tie2), and matrix metallopeptidase 9 (MMP-9), and immunohistochemistry to assess capillarization in skeletal muscle post-training. There was an overall increase in the expression levels of VEGF, VEGFR-2, HIF-1α, Ang2, and MMP9 post-training, while these changes were not different among groups. Changes in capillary-to-fibre ratio were found to be strongly associated with Tie2 and HIF-1α expression. This was the first study demonstrating that both HIIT and combined HIIT with strength training enhanced similarly the expression profile of angiogenic factors in skeletal muscle of HF patients, possibly driving the angiogenic program in the trained muscles, although those gene expression increases were found to be only partially related with muscle capillarization.",2021,Changes in capillary-to-fibre ratio were found to be strongly associated with Tie2 and HIF-1α expression.,"['Patients with Chronic Heart Failure', 'Thirteen male patients with chronic HF (age: 51 ± 13 y; BMI: 27 ± 4 kg/m 2 ', 'HF patients']","['high-intensity-interval-training (HIIT) or combined HIIT with strength training (COM) exercise protocol', 'Exercise Training', 'exercise program that consisted of either HIIT ( N  = 6) or COM training']","['expression levels of VEGF, VEGFR-2, HIF-1α, Ang2, and MMP9 post-training', 'mRNA expression of vascular endothelial growth factor (VEGF), vascular endothelial growth factor receptor 2 (VEGFR-2), hypoxia-inducible factor 1 alpha (HIF-1α), angiopoietin 1 (Ang-1), angiopoietin 2 (Ang-2), angiopoietin receptor (Tie2), and matrix metallopeptidase 9 (MMP-9']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0378796', 'cui_str': 'KDR Tyrosine Kinase'}, {'cui': 'C3849511', 'cui_str': 'ANGPT2 protein, human'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C1528322', 'cui_str': 'HIF1A protein, human'}, {'cui': 'C0533668', 'cui_str': 'ANGPT1 protein, human'}, {'cui': 'C0540511', 'cui_str': 'Angiopoietin 2'}, {'cui': 'C1113649', 'cui_str': 'Angiopoietins'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C2736430', 'cui_str': 'Matrix metallopeptidase 9'}]",13.0,0.00713891,Changes in capillary-to-fibre ratio were found to be strongly associated with Tie2 and HIF-1α expression.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tryfonos', 'Affiliation': 'Department of Physiology, Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Giorgos', 'Initials': 'G', 'LastName': 'Tzanis', 'Affiliation': 'Clinical Ergospirometry, Exercise & Rehabilitation Laboratory, Evaggelismos Hospital, National and Kapodistrian University of Athens, 10676 Athens, Greece.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Pitsolis', 'Affiliation': 'First Department of Intensive Care, Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Karatzanos', 'Affiliation': 'Clinical Ergospirometry, Exercise & Rehabilitation Laboratory, Evaggelismos Hospital, National and Kapodistrian University of Athens, 10676 Athens, Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koutsilieris', 'Affiliation': 'Department of Physiology, Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Serafim', 'Initials': 'S', 'LastName': 'Nanas', 'Affiliation': 'Clinical Ergospirometry, Exercise & Rehabilitation Laboratory, Evaggelismos Hospital, National and Kapodistrian University of Athens, 10676 Athens, Greece.'}, {'ForeName': 'Anastassios', 'Initials': 'A', 'LastName': 'Philippou', 'Affiliation': 'Department of Physiology, Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece.'}]",Cells,['10.3390/cells10081915']
1424,34448282,"The impact of Helicobacter pylori infection, eradication therapy, and probiotics intervention on gastric microbiota in young adults.","BACKGROUND


The impact of probiotics on non-Helicobacter pylori gastric microbiota and its role in microbial restoration after eradication were relatively unknown. We aimed to explore the effect of H. pylori eradication and probiotic intervention on gastric microbiota in young adults.
METHODS


Fifty-six H. pylori-negative and 95 H. pylori-positive subjects aged 19-30 were included in this study. H. pylori-infected individuals were randomly assigned to quadruple therapy, probiotics supplemented quadruple therapy, or probiotics monotherapy group. Gastric mucosa and gastric juice samples were collected before and 2 months after treatment for 16SrRNA gene sequencing.
RESULTS


The gastric microbial community structure and composition differed from H. pylori-negative subjects 2 months after successful H. pylori eradication. The α diversity of gastric mucosal microbiota significantly increased and was higher than H. pylori-negative subjects, while the α diversity of gastric juice microbiota decreased and was lower than the H. pylori-negative. After probiotics supplemented eradication treatment, Bifidobacterium was enriched in gastric mucosa, Lactobacillus was enriched in gastric juice, potentially pathogenic bacteria such as Fusobacterium and Campylobacter decreased, and the microbial diversity was closer to that of H. pylori-negative subjects compared to quadruple therapy group. Probiotics monotherapy significantly altered the diversity, community structure, and composition of gastric microbiota but showed no advantage in H. pylori inhibition and upregulating beneficial bacteria such as Bifidobacterium and Lactobacillus and related metabolism pathways. Certain potentially pathogenic bacteria such as Fusobacterium increased after probiotic monotherapy.
CONCLUSION


H. pylori eradication significantly disrupted gastric microbiota in young adults and could not be restored in a short time. Probiotics supplementation partially helped restore the gastric dysbiosis caused by eradication therapy, but it might be unnecessary for H. pylori-infected young adults to take probiotics alone.",2021,The gastric microbial community structure and composition differed from H. pylori-negative subjects 2 months after successful H. pylori eradication.,"['pylori-negative and 95 H.\xa0pylori-positive subjects aged 19-30', 'Fifty-six H', 'H.\xa0pylori-infected individuals', 'young adults']","['probiotic intervention', 'Probiotics supplementation', 'Probiotics monotherapy', 'probiotics intervention', 'quadruple therapy, probiotics supplemented quadruple therapy, or probiotics monotherapy']","['Gastric mucosa and gastric juice samples', 'gastric microbiota', 'α diversity of gastric mucosal microbiota', 'diversity, community structure, and composition of gastric microbiota', 'α diversity of gastric juice microbiota']","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0017136', 'cui_str': 'Gastric mucous membrane structure'}, {'cui': 'C0444139', 'cui_str': 'Gastric fluid sample'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0017133', 'cui_str': 'Gastric juice'}]",,0.0260263,The gastric microbial community structure and composition differed from H. pylori-negative subjects 2 months after successful H. pylori eradication.,"[{'ForeName': 'Ziying', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Shiyu', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Sizhu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Baojun', 'Initials': 'B', 'LastName': 'Suo', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Lingmei', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Zuojing', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}]",Helicobacter,['10.1111/hel.12848']
1425,34446791,Neurofeedback training improves episodic and semantic long-term memory performance.,"Understanding and improving memory are vital to enhance human life. Theta rhythm is associated with memory consolidation and coding, but the trainability and effects on long-term memory of theta rhythm are unknown. This study investigated the ability to improve long-term memory using a neurofeedback (NFB) technique reflecting the theta/low-beta power ratio on an electroencephalogram (EEG). Our study consisted of three stages. First, the long-term memory of participants was measured. In the second stage, the participants in the NFB group received 3 days of theta/low-beta NFB training. In the third stage, the long-term memory was measured again. The NFB group had better episodic and semantic long-term memory than the control group and significant differences in brain activity between episodic and semantic memory during the recall tests were revealed. These findings suggest that it is possible to improve episodic and semantic long-term memory abilities through theta/low-beta NFB training.",2021,The NFB group had better episodic and semantic long-term memory than the control group and significant differences in brain activity between episodic and semantic memory during the recall tests were revealed.,[],"['NFB', 'neurofeedback (NFB) technique reflecting the theta/low-beta power ratio', 'Neurofeedback training']","['episodic and semantic long-term memory abilities', 'brain activity between episodic and semantic memory', 'episodic and semantic long-term memory performance', 'episodic and semantic long-term memory']",[],"[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0423909', 'cui_str': 'Long-term memory performance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0542312', 'cui_str': 'Semantic memory'}]",,0.0382539,The NFB group had better episodic and semantic long-term memory than the control group and significant differences in brain activity between episodic and semantic memory during the recall tests were revealed.,"[{'ForeName': 'Yu-Hsuan', 'Initials': 'YH', 'LastName': 'Tseng', 'Affiliation': 'Graduate School of Systems Life Sciences, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Faculty of Information Engineering, Fukuoka Institute of Technology, 3-30-1 Wajiro-higashi, Higashi-ku, Fukuoka, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Graduate School of Systems Life Sciences, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka, Japan. okamoto@artsci.kyushu-u.ac.jp.'}]",Scientific reports,['10.1038/s41598-021-96726-5']
1426,34453996,The impact of the nutri-score on food choice: A choice experiment in a Dutch supermarket.,"Front-of-package (FOP) nutrition labels are placed on products to help consumers make healthy food choices. A lab-in-field experiment was conducted to test the effectiveness of two FOP labels in promoting healthy food choices among Dutch consumers, and to examine whether dieters and health conscious shoppers are more likely to use the FOP labels. In addition, it was examined whether the placement of relatively ""good"" FOP label scores on products might inadvertently lead to increases in serving sizes. Participants (N = 300) consisted of Dutch consumers shopping for groceries in a local supermarket. They were randomly assigned to one of three conditions (Nutri-score, Multiple Traffic Light (MTL) label, or no label control condition), presented with six different (labeled) cereals, and asked to make a choice. Next, participants were shown a product with a relatively good label score and selected their desired serving size. The results show that the Nutri-score promotes choice of the healthiest cereal. Dieting behaviour and health conscious shopping did not moderate this effect, and the labels did not affect serving size selection. Overall, the study provides evidence for the Nutri-score to promote healthy food choices among Dutch consumers.",2021,"Dieting behaviour and health conscious shopping did not moderate this effect, and the labels did not affect serving size selection.","['a Dutch supermarket', 'Participants (N\u202f=\u202f300) consisted of Dutch consumers shopping for groceries in a local supermarket']","['FOP labels', 'Front-of-package (FOP) nutrition labels', 'Multiple Traffic Light (MTL) label, or no label control condition), presented with six different (labeled) cereals']",[],"[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}]",[],,0.0414182,"Dieting behaviour and health conscious shopping did not moderate this effect, and the labels did not affect serving size selection.","[{'ForeName': 'Karolien', 'Initials': 'K', 'LastName': 'van den Akker', 'Affiliation': 'CentERdata, Tilburg University, Intermezzo Building, Professor de Moorplein 524-525, P.O. Box 90153, 5037 DR, Tilburg, the Netherlands. Electronic address: karolien.van.den.akker@centerdata.nl.'}, {'ForeName': 'Dimona', 'Initials': 'D', 'LastName': 'Bartelet', 'Affiliation': 'Laboratory of Behavioural Gastronomy, Centre for Healthy Eating and Food Innovation, Maastricht University Campus Venlo, the Netherlands.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Brouwer', 'Affiliation': 'CentERdata, Tilburg University, Intermezzo Building, Professor de Moorplein 524-525, P.O. Box 90153, 5037 DR, Tilburg, the Netherlands.'}, {'ForeName': 'Syrah', 'Initials': 'S', 'LastName': 'Luijpers', 'Affiliation': 'CentERdata, Tilburg University, Intermezzo Building, Professor de Moorplein 524-525, P.O. Box 90153, 5037 DR, Tilburg, the Netherlands.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nap', 'Affiliation': 'CentERdata, Tilburg University, Intermezzo Building, Professor de Moorplein 524-525, P.O. Box 90153, 5037 DR, Tilburg, the Netherlands.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Havermans', 'Affiliation': 'Laboratory of Behavioural Gastronomy, Centre for Healthy Eating and Food Innovation, Maastricht University Campus Venlo, the Netherlands.'}]",Appetite,['10.1016/j.appet.2021.105664']
1427,34453917,Sustained Inflation Versus Intermittent Positive Pressure Ventilation for Preterm Infants at Birth: Respiratory Function and Vital Sign Measurements.,"OBJECTIVE


To characterize respiratory function monitor (RFM) measurements of sustained inflations and intermittent positive pressure ventilation (IPPV) delivered noninvasively to infants in the Sustained Aeration of Infant Lungs (SAIL) trial and to compare vital sign measurements between treatment arms.
STUDY DESIGN


We analyzed RFM data from SAIL participants at 5 trial sites. We assessed tidal volumes, rates of airway obstruction, and mask leak among infants allocated to sustained inflations and IPPV, and we compared pulse rate and oxygen saturation measurements between treatment groups.
RESULTS


Among 70 SAIL participants (36 sustained inflations, 34 IPPV) with RFM measurements, 40 (57%) were spontaneously breathing prior to the randomized intervention. The median expiratory tidal volume of sustained inflations administered was 5.3 mL/kg (IQR 1.1-9.2). Significant mask leak occurred in 15% and airway obstruction occurred during 17% of sustained inflations. Among 34 control infants, the median expiratory tidal volume of IPPV inflations was 4.3 mL/kg (IQR 1.3-6.6). Mask leak was present in 3%, and airway obstruction was present in 17% of IPPV inflations. There were no significant differences in pulse rate or oxygen saturation measurements between groups at any point during resuscitation.
CONCLUSION


Expiratory tidal volumes of sustained inflations and IPPV inflations administered in the SAIL trial were highly variable in both treatment arms. Vital sign values were similar between groups throughout resuscitation. Sustained inflation as operationalized in the SAIL trial was not superior to IPPV to promote lung aeration after birth in this study subgroup.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT02139800.",2021,"There were no significant differences in pulse rate or SpO 2  measurements between groups at any point during resuscitation.
","['34 control infants', 'Preterm Infants at Birth', '70 SAIL participants (36 SI, 34 IPPV) with RFM measurements, 40 (57%) were spontaneously breathing prior to the randomized intervention']","['sustained inflations and intermittent positive pressure ventilation (IPPV', 'Sustained Inflation Versus Intermittent Positive Pressure Ventilation']","['median Vte of IPPV inflations', 'Expiratory tidal volumes of SI and IPPV inflations', 'Significant mask leak', 'Mask leak', 'pulse rate and oxygen saturation (SpO 2 ) measurements', 'pulse rate or SpO 2  measurements', 'tidal volumes, rates of airway obstruction and mask leak', 'median expiratory tidal volume (Vte) of SIs', 'airway obstruction', 'Vital sign values']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",70.0,0.0980102,"There were no significant differences in pulse rate or SpO 2  measurements between groups at any point during resuscitation.
","[{'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Foglia', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Electronic address: foglia@chop.edu.'}, {'ForeName': 'Haresh', 'Initials': 'H', 'LastName': 'Kirpalani', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Ratcliffe', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Davis', 'Affiliation': ""Newborn Research Center, The Royal Women's Hospital and The University of Melbourne, Victoria, Australia.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Thio', 'Affiliation': ""Newborn Research Center, The Royal Women's Hospital and The University of Melbourne, Victoria, Australia.""}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hummler', 'Affiliation': 'Department of Pediatrics, Sidra Medicine, Doha, Qatar.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Lista', 'Affiliation': 'Department of Pediatrics, NICU, Ospedale dei Bambini V.Buzzi ASST-FBF-Sacco, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cavigioli', 'Affiliation': 'Department of Pediatrics, NICU, Ospedale dei Bambini V.Buzzi ASST-FBF-Sacco, Milan, Italy.'}, {'ForeName': 'Georg M', 'Initials': 'GM', 'LastName': 'Schmölzer', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Keszler', 'Affiliation': 'Department of Pediatrics, Alpert Medical School of Brown University, Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Arjan B', 'Initials': 'AB', 'LastName': 'Te Pas', 'Affiliation': 'Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2021.08.038']
1428,34459211,"Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.","BACKGROUND


Observational and small, randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease.
METHODS


We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI; 99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary end point was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary end points: all-cause death, cardiovascular death, MI, and stent thrombosis.
RESULTS


Because of the COVID-19 pandemic, the data safety and monitoring board recommended to halt the trial before attaining the prespecified sample size. Between October 1, 2016, and March 1, 2020, 2571 participants were randomized at 30 centers across 8 countries. Participants assigned to influenza vaccine totaled 1290 and individuals assigned to placebo equaled 1281; of these, 2532 received the study treatment (1272 influenza vaccine and 1260 placebo) and were included in the modified intention to treat analysis. Over the 12-month follow-up, the primary outcome occurred in 67 participants (5.3%) assigned influenza vaccine and 91 participants (7.2%) assigned placebo (hazard ratio, 0.72 [95% CI, 0.52-0.99];  P =0.040). Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59 [95% CI, 0.39-0.89];  P =0.010), rates of cardiovascular death were 2.7% and 4.5%, (hazard ratio, 0.59 [95% CI, 0.39-0.90];  P =0.014), and rates of MI were 2.0% and 2.4% (hazard ratio, 0.86 [95% CI, 0.50-1.46];  P =0.57) in the influenza vaccine and placebo groups, respectively.
CONCLUSIONS


Influenza vaccination early after an MI or in high-risk coronary heart disease resulted in a lower risk of a composite of all-cause death, MI, or stent thrombosis, and a lower risk of all-cause death and cardiovascular death, as well, at 12 months compared with placebo. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02831608.",2021,"Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59; 0.39 to 0.89; P=0.010), of cardiovascular death 2.7% and 4.5%, (hazard ratio, 0.59; 0.39 to 0.90; P=0.014), and of MI 2.0% and 2.4% (hazard ratio, 0.86; 0.50 to 1.46, P=0.57) in the influenza vaccine and placebo groups, respectively.  ","['patients with cardiovascular disease', 'Between October 1, 2016, and March 1, 2020, 2571 participants were randomized at 30 centers across eight countries; 1290 assigned to', 'myocardial infarction (MI) (99.7% of patients) or high-risk stable coronary heart disease (0.3', 'after Myocardial Infarction']","['Influenza Vaccination', 'inactivated influenza vaccine with saline placebo', 'Placebo', 'influenza vaccine', 'placebo']","['cardiovascular death', 'death, cardiovascular death, MI, and stent thrombosis', 'composite of all-cause death, MI, or stent thrombosis', 'Rates of all-cause death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4068885', 'cui_str': '0.3'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",2571.0,0.954969,"Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59; 0.39 to 0.89; P=0.010), of cardiovascular death 2.7% and 4.5%, (hazard ratio, 0.59; 0.39 to 0.90; P=0.014), and of MI 2.0% and 2.4% (hazard ratio, 0.86; 0.50 to 1.46, P=0.57) in the influenza vaccine and placebo groups, respectively.  ","[{'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Örebro University, Faculty of Health, Department of Cardiology, Sweden (O.F., F.C.).'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Götberg', 'Affiliation': 'Department of Cardiology, Skane University Hospital, Clinical Sciences, Lund University, Sweden (M.G., D.E., A.M.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Skane University Hospital, Clinical Sciences, Lund University, Sweden (M.G., D.E., A.M.).'}, {'ForeName': 'Zubair', 'Initials': 'Z', 'LastName': 'Akhtar', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka (Z.A.).'}, {'ForeName': 'Evald H', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Denmark (E.H.C., L.J.).'}, {'ForeName': 'Chandini R', 'Initials': 'CR', 'LastName': 'MacIntyre', 'Affiliation': 'The Kirby Institute, UNSW Medicine, University of New South Wales, Sydney, Australia (C.R.M.).'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom, and West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (K.G.O.).'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Motovska', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University, and University Hospital Kralovske Vinohrady, Prague, Czech Republic (Z.M.).'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Pauls Stradins Clinical University Hospital, University of Latvia, Riga (A.E.).'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Moer', 'Affiliation': 'LHL-sykehuset Gardermoen, Oslo, Norway (R.M.).'}, {'ForeName': 'Ota', 'Initials': 'O', 'LastName': 'Hlinomaz', 'Affiliation': 'International clinical research center, St. Anne University Hospital and Masaryk University, Brno, Czech Republic (O.H.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Denmark (E.H.C., L.J.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Denmark (T.E.).'}, {'ForeName': 'Lisette O', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.O.J., C.O.F.).'}, {'ForeName': 'Christian O', 'Initials': 'CO', 'LastName': 'Fallesen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.O.J., C.O.F.).'}, {'ForeName': 'Svend E', 'Initials': 'SE', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, and Department of Clinical Medicine, Aalborg University, Denmark (S.E.J.).'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Angerås', 'Affiliation': 'Sahlgrenska University Hospital and Institute of Medicine, Department of molecular and clinical medicine, Gothenburg University, Sweden (O.A.).'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Calais', 'Affiliation': 'Örebro University, Faculty of Health, Department of Cardiology, Sweden (O.F., F.C.).'}, {'ForeName': 'Amra', 'Initials': 'A', 'LastName': 'Kåregren', 'Affiliation': 'Västmanlands sjukhus Västerås, Sweden (A.K.).'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Lauermann', 'Affiliation': 'Department of Cardiology, Jönköping, Region Jönköping County, and Department of Health, Medicine and Caring, Linköping University, Sweden (J.L.).'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mokhtari', 'Affiliation': 'Department of Cardiology, Skane University Hospital, Clinical Sciences, Lund University, Sweden (M.G., D.E., A.M.).'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Nilsson', 'Affiliation': 'Cardiology, Heart Centre, Department of Public Health and Clinical Medicine, Umeå University, Sweden (J.N.).'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden (J. Persson).'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Stalby', 'Affiliation': 'Department of Cardiology, Karlstad Central Hospital, Sweden (P.S.).'}, {'ForeName': 'Abu K M M', 'Initials': 'AKMM', 'LastName': 'Islam', 'Affiliation': 'National Institute of Cardiovascular Diseases, Sher-e-Bangla Nagar, Dhaka, Bangladesh (A.K.K.M.I., A.R.).'}, {'ForeName': 'Afzalur', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'National Institute of Cardiovascular Diseases, Sher-e-Bangla Nagar, Dhaka, Bangladesh (A.K.K.M.I., A.R.).'}, {'ForeName': 'Fazila', 'Initials': 'F', 'LastName': 'Malik', 'Affiliation': 'National Heart Foundation Hospital and Research Institute, Dhaka, Bangladesh (F.M., S.C.).'}, {'ForeName': 'Sohel', 'Initials': 'S', 'LastName': 'Choudhury', 'Affiliation': 'National Heart Foundation Hospital and Research Institute, Dhaka, Bangladesh (F.M., S.C.).'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Collier', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (T.C., S.J.P.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (T.C., S.J.P.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pernow', 'Affiliation': 'Cardiology Unit, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden (J. Pernow).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.057042']
1429,34455355,#Beautyunedited: Is labeling unedited selfies helpful for body image and mood among young women?,"Research has shown that social media content that has not been digitally altered may help support positive body image. However, the effects of adding labels to such images has received little research attention. This study compared the effects of selfies that were: edited, unedited, and unedited + labeled. A sample of 350 young women, mean age (SD) = 21.87 (2.28) years, were randomly allocated to one of three conditions and completed pre and post exposure measures of state body image and mood, as well as trait risk and protective factors. Findings revealed that participants allocated to the unedited + labeled condition reported greater increases in state appearance satisfaction as compared to those who viewed the edited selfies. In addition, participants with higher levels of social media literacy benefited most from the unedited + labeled selfies. Findings suggest that selfies bearing a label indicating that they have not been edited may be more helpful for body image among young women as comapred to edited selfies. Thus, labels could represent useful social marketing tools on social media and contribute to efforts to increase the realism of social media imagery.",2021,Findings revealed that participants allocated to the unedited + labeled condition reported greater increases in state appearance satisfaction as compared to those who viewed the edited selfies.,"['\u202f21.87 (2.28) years', 'young women', '350 young women, mean age (SD']",[],"['state appearance satisfaction', 'social media literacy']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]",350.0,0.016397,Findings revealed that participants allocated to the unedited + labeled condition reported greater increases in state appearance satisfaction as compared to those who viewed the edited selfies.,"[{'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Rodgers', 'Affiliation': 'APPEAR, Department of Applied Psychology, Northeastern University, Boston, USA; Department of Psychiatric Emergency & Acute Care, Lapeyronie Hospital, CHRU Montpellier, France. Electronic address: r.rodgers@northeastern.edu.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Lowy', 'Affiliation': 'APPEAR, Department of Applied Psychology, Northeastern University, Boston, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Kodama', 'Affiliation': 'APPEAR, Department of Applied Psychology, Northeastern University, Boston, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bujold', 'Affiliation': 'APPEAR, Department of Applied Psychology, Northeastern University, Boston, USA.'}]",Body image,['10.1016/j.bodyim.2021.08.001']
1430,34460973,Randomised clinical trial: the effects of pregabalin vs placebo on functional dyspepsia.,"BACKGROUND


Currently, central neuromodulators are among the therapeutic options for the treatment of functional dyspepsia (FD). Pregabalin, a gabapentinoid, is a neuromodulator that could potentially improve visceral hypersensitivity in FD patients.
AIM


To assess the efficacy and safety of pregabalin for the treatment of FD METHODS: We performed a randomised placebo-controlled study including FD patients who did not respond to proton pump inhibitors. Patients were randomly assigned to receive pregabalin (75 mg daily) or placebo for 8 weeks. The primary outcome was an adequate relief response rate. The secondary outcomes were improvement in quality of life, pain scores in divided categories, and safety profile.
RESULTS


Of 72 patients enrolled, 34 received pregabalin and 38 received placebo. The self-reported adequate relief rates in the pregabalin and placebo groups were 70.6% and 42.1% at week 4 (P = 0.02), and 70.6% and 44.7% at week 8 (P = 0.03), respectively. The reduction in global symptoms in the pregabalin and placebo groups were 11.7 ± 10.6 and 3.7 ± 8.9 points at week 4 (P < 0.01) and 15.1 ± 12.2 and 8.0 ± 10.2 points at week 8 (P = 0.01), respectively. Pregabalin improved the overall quality of life (P = 0.03). The most common adverse event with pregabalin was dizziness, occurring in 51.6% of patients.
CONCLUSIONS


Pregabalin led to significant alleviation of dyspeptic symptoms, especially in patients with predominant epigastric pain . Thaiclinicaltrials.org #TCTR20200404002.",2021,"The most common adverse event with pregabalin was dizziness, occurring in 51.6% of patients.
","['FD patients who did not respond to proton pump inhibitors', 'FD patients', '72 patients enrolled, 34 received', 'patients with predominant epigastric pain ']","['pregabalin', 'Pregabalin', 'placebo', 'pregabalin vs placebo']","['global symptoms', 'efficacy and safety', 'functional dyspepsia', 'overall quality of life', 'quality of life, pain scores in divided categories, and safety profile', 'visceral hypersensitivity', 'adequate relief rates', 'dyspeptic symptoms', 'adequate relief response rate', 'dizziness']","[{'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",72.0,0.346601,"The most common adverse event with pregabalin was dizziness, occurring in 51.6% of patients.
","[{'ForeName': 'Isariyaphong', 'Initials': 'I', 'LastName': 'Kotikula', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Nithi', 'Initials': 'N', 'LastName': 'Thinrungroj', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Pinyopornpanish', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Phuripong', 'Initials': 'P', 'LastName': 'Kijdamrongthum', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Apinya', 'Initials': 'A', 'LastName': 'Leerapun', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Taned', 'Initials': 'T', 'LastName': 'Chitapanarux', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Satawat', 'Initials': 'S', 'LastName': 'Thongsawat', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Ong-Ard', 'Initials': 'OA', 'LastName': 'Praisontarangkul', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16588']
1431,34464847,Positive effects of the enhanced recovery after surgery (ERAS) protocol in DIEP flap breast reconstruction.,"BACKGROUND


Enhanced recovery after surgery protocols are successfully implemented in different surgical specialties, but a specific protocol for autologous breast reconstruction is missing. The aim of this study was to determine whether an enhanced recovery after surgery (ERAS) protocol contributes to a reduced length of stay without an increase in postoperative complications for patients undergoing a DIEP flap breast reconstruction.
MATERIALS EN METHODS


The effect of the ERAS protocol was examined using a single-center patient-control study comparing two groups of patients. Patients who underwent surgery between November 2017 and November 2018 using the ERAS protocol were compared with a historical control group (pre-ERAS) who underwent surgery between November 2016 and November 2017. The primary outcome measure was hospital length of stay. Secondary outcome measures were postoperative pain and postoperative complications.
RESULTS


152 patients were included (ERAS group, n = 73; control group, n = 79). Mean hospital length of stay was significantly shorter in the ERAS group than in the control group (5 vs. 6 days, p < 0.001). The average pain score was 1.73 in de the ERAS group compared to 2.17 in the control group (p = 0.032). There were no significant differences between the groups in postoperative complications. The ERAS group experienced less constipation (41 vs. 25 patients, p = 0.028).
CONCLUSION


An enhanced recovery after surgery protocol contributes an accelerated postoperative recovery of patients undergoing a DIEP flap breast reconstruction. In this study a significant decrease was found in hospital length of stay, patient-reported pain score and adverse health issues.",2021,"In this study a significant decrease was found in hospital length of stay, patient-reported pain score and adverse health issues.","['DIEP flap breast reconstruction', '152 patients were included (ERAS group, n\xa0=\xa073; control group, n\xa0=\xa079', 'Patients who underwent surgery between November 2017 and November 2018 using the ERAS protocol were compared with a historical control group (pre-ERAS) who underwent surgery between November 2016 and November 2017', 'patients undergoing a DIEP flap breast reconstruction']","['surgery (ERAS) protocol', 'ERAS']","['average pain score', 'constipation', 'hospital length of stay', 'postoperative pain and postoperative complications', 'Mean hospital length of stay', 'postoperative complications', 'hospital length of stay, patient-reported pain score and adverse health issues']","[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",152.0,0.145837,"In this study a significant decrease was found in hospital length of stay, patient-reported pain score and adverse health issues.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gort', 'Affiliation': 'Radboud University Medical Center, Dept. of Plastic Surgery, Nijmegen, the Netherlands. Electronic address: nienke.gort@radboudumc.nl.'}, {'ForeName': 'B G I', 'Initials': 'BGI', 'LastName': 'van Gaal', 'Affiliation': 'HAN University of Applied Sciences, School of Health Studies, Nijmegen, the Netherlands; Radboud University Medical Center, Radboud Institute for Health Science, IQ Healthcare, Nijmegen, the Netherlands.'}, {'ForeName': 'H J P', 'Initials': 'HJP', 'LastName': 'Tielemans', 'Affiliation': 'Radboud University Medical Center, Dept. of Plastic Surgery, Nijmegen, the Netherlands.'}, {'ForeName': 'D J O', 'Initials': 'DJO', 'LastName': 'Ulrich', 'Affiliation': 'Radboud University Medical Center, Dept. of Plastic Surgery, Nijmegen, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hummelink', 'Affiliation': 'Radboud University Medical Center, Dept. of Plastic Surgery, Nijmegen, the Netherlands.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2021.08.010']
1432,34433362,Switching COPD patients from the disposable to the new reusable Respimat soft mist inhaler: a real-world study from Switzerland.,"OBJECTIVE


The aims of the survey were to assess first experiences of Swiss COPD patients switching from the disposable to the new reusable Respimat inhaler, and to evaluate physicians´ and patients´ views of the new training material.
METHODS


Patients with a confirmed diagnosis of COPD using a disposable Respimat inhaler for at least three months were included. Patients´ demographics, COPD stage, current treatment, and comorbidities relevant for the handling of the device were assessed. Further, patients were trained on the reusable Respimat by placebo inhaler, patient brochure, video cards/demo films and SMS reminder service. After at least one cartridge change, patients gave comprehensive feedback on their satisfaction with the reusable Respimat and physicians evaluated the need for re-training.
RESULTS


235 patients participated in the survey. Of these, 37% suffered from comorbidities restricting the handling of the Respimat. 216 (92%) patients had a better overall satisfaction with the reusable than with the disposable Respimat. Dose counter (86%), monthly preparation (81%) and daily handling (77%) were also assessed as better by most of the patients. In 80% of cases, the user ability was stated as better than for the disposable Respimat. Less than 15% of the patients required further training. Placebo inhaler was the mostly preferred training material by both, physicians (in 86% of the patients) and patients (75%). In patients with comorbidities affecting inhaler handling, overall satisfaction was also better in 86% of the patients.
CONCLUSION


The majority of patients were satisfied with the new reusable Respimat device and proper handling could be attained using the provided training material, even in patients with restricting comorbidities.",2021,"The majority of patients were satisfied with the new reusable Respimat ®  device and proper handling could be attained using the provided training material, even in patients with restricting comorbidities.","['Patients with a confirmed diagnosis of COPD using a disposable Respimat ®  inhaler for at least three months were included', '235 patients participated in the survey', 'Swiss COPD patients', '216']",['Placebo'],['overall satisfaction'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C4708905', 'cui_str': '216'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",235.0,0.0309212,"The majority of patients were satisfied with the new reusable Respimat ®  device and proper handling could be attained using the provided training material, even in patients with restricting comorbidities.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tschacher', 'Affiliation': 'University Clinic of Medicine, Cantonal Hospital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Cadus', 'Affiliation': 'University Clinic of Medicine, Cantonal Hospital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schildge', 'Affiliation': 'Boehringer Ingelheim GmbH, Basel, Switzerland.'}, {'ForeName': 'Jens Peter', 'Initials': 'JP', 'LastName': 'Diedrich', 'Affiliation': 'Boehringer Ingelheim GmbH, Basel, Switzerland.'}, {'ForeName': 'Prashant N', 'Initials': 'PN', 'LastName': 'Chhajed', 'Affiliation': 'University Clinic of Medicine, Cantonal Hospital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Leuppi-Taegtmeyer', 'Affiliation': 'University Clinic of Medicine, Cantonal Hospital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Jörg Daniel', 'Initials': 'JD', 'LastName': 'Leuppi', 'Affiliation': 'University Clinic of Medicine, Cantonal Hospital Baselland, Liestal, Switzerland.'}]",Current medical research and opinion,['10.1080/03007995.2021.1969354']
1433,34438469,Colchicine for acute gout.,"BACKGROUND


This is an updated Cochrane Review, first published in 2006 and updated in 2014. Gout is one of the most common rheumatic diseases worldwide. Despite the use of colchicine as one of the first-line therapies for the treatment of acute gout, evidence for its benefits and harms is relatively limited.
OBJECTIVES


To update the available evidence of the benefits and harms of colchicine for the treatment of acute gout.
SEARCH METHODS


We updated the search of CENTRAL, MEDLINE, Embase, Clinicaltrials.gov and WHO ICTRP registries to 28 August 2020. We did not impose any date or language restrictions in the search.
SELECTION CRITERIA


We considered published randomised controlled trials (RCTs) and quasi-randomised controlled trials (quasi-RCTs) evaluating colchicine therapy compared with another therapy (placebo or active) in acute gout; low-dose colchicine at clinically relevant doses compared with placebo was the primary comparison. The major outcomes were pain, participant global assessment of treatment success (proportion with 50% or greater decrease in pain from baseline up to 32 to 36 hours), reduction of inflammation, function of target joint, serious adverse events, total adverse events and withdrawals due to adverse events.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures as expected by Cochrane in this review update.
MAIN RESULTS


We included four trials (803 randomised participants), including two new trials, in this updated review. One three-arm trial compared high-dose colchicine (52 participants), low-dose colchicine (74 participants) and placebo (59 participants); one trial compared high-dose colchicine with placebo (43 participants); one trial compared low-dose colchicine with non-steroidal anti-inflammatory drugs (NSAIDs) (399 participants); and one trial compared low-dose colchicine with Chuanhu anti-gout mixture (traditional Chinese Medicine compound) (176 participants). We did not identify any trials comparing colchicine to glucocorticoids (by any route). The mean age of participants ranged from 51.2 to 70 years, and trial duration from 48 hours to 12 weeks. Two trials were at low risk of bias, one was possibly susceptible to selection bias (random sequence generation), reporting bias and other bias, and one open-label trial was at high risk of performance and detection bias. For the primary comparison, low-quality evidence from one trial (103 participants, downgraded for imprecision and bias) suggests low-dose colchicine may improve treatment outcome compared to placebo with little or no increased risk of adverse events. The number of people who reported treatment success (50% or greater pain reduction) at 32 to 36 hours was slightly larger with low-dose colchicine (418 per 1000) compared with placebo (172 per 1000; risk ratio (RR) 2.43, 95% confidence interval (CI) 1.05 to 5.64; absolute improvement 25% more reported success (7% more to 42% more, the 95% CIs include both a clinically important and unimportant benefit); relative change of 143% more people reported treatment success (5% more to 464% more). The incidence of total adverse events was 364 per 1000 with low-dose colchicine compared with 276 per 1000 with placebo: RR 1.32, 95% CI 0.68 to 2.56; absolute difference 9% more events with low-dose colchicine (9% fewer to 43% more, the 95% CIs include both a clinically important effect and no effect); relative change of 32% more events (32% fewer to 156% more). No participants withdrew due to adverse events or reported any serious adverse events. Pain, inflammation and function were not reported. Low-quality evidence (downgraded for imprecision and bias) from two trials (124 participants) suggests that high-dose colchicine compared to placebo may improve symptoms, but with increased risk of harms. More participants reported treatment success at 32 to 36 hours with high-dose colchicine (518 per 1000) compared with placebo (240 per 1000): RR 2.16, 95% CI 1.28 to 3.65, absolute improvement 28% (8% more to 46% more); more also had reduced inflammation at this time point with high-dose colchicine (504 per 1000) compared with placebo (48 per 1000): RR 10.50, 95% CI 1.48 to 74.38; absolute improvement 45% greater (22% greater to 68% greater); but more adverse events were reported with high-dose colchicine (829 per 1000 compared with 260 per 1000): RR 3.21, 95% CI 2.01 to 5.11, absolute difference 57% (26% more to 74% more). Pain and function were not reported. Low-quality evidence from a single trial comparing high-dose to low-dose colchicine indicates there may be little or no difference in benefit in terms of treatment success at 32 to 36 hours but more adverse events associated with the higher dose. Similarly, low-quality evidence from a single trial indicates there may also be little or no benefit of low-dose colchicine over NSAIDs in terms of treatment success and pain reduction at seven days, with a similar number of adverse events reported at four weeks follow-up. Reduction of inflammation, function of target joint and withdrawals due to adverse events were not reported in either of these trials, and pain was not reported in the high-dose versus low-dose colchicine trial. We were unable to estimate the risk of serious adverse events for most comparisons as there were few events reported in the trials. One trial (399 participants) reported three serious adverse (one in a participant receiving low-dose colchicine and two in participants receiving NSAIDs), due to reasons unrelated to the trial (low-quality evidence downgraded for bias and imprecision).
AUTHORS' CONCLUSIONS


We found low-quality evidence that low-dose colchicine may be an effective treatment for acute gout when compared to placebo and low-quality evidence that its benefits may be similar to NSAIDs. We downgraded the evidence for bias and imprecision. While both high- and low-dose colchicine improve pain when compared to placebo, low-quality evidence suggests that high-dose (but not low-dose) colchicine may increase the number of adverse events compared to placebo, while low-quality evidence indicates that the number of adverse events may be similar with low-dose colchicine and NSAIDs. Further trials comparing colchicine to placebo or other treatment will likely have an important impact on our confidence in the effect estimates and may change the conclusions of this review. There are no trials reporting the effect of colchicine in populations with comorbidities or in comparison with other commonly used treatments, such as glucocorticoids.",2021,"Reduction of inflammation, function of target joint and withdrawals due to adverse events were not reported in either of these trials, and pain was not reported in the high-dose versus low-dose colchicine trial.","['acute gout', 'The mean age of participants ranged from 51.2 to 70 years, and trial duration from 48 hours to 12 weeks']","['colchicine to glucocorticoids', 'colchicine with placebo', 'colchicine therapy', 'another therapy (placebo or active', 'colchicine', 'colchicine with non-steroidal anti-inflammatory drugs (NSAIDs) (399 participants); and one trial compared low-dose colchicine with Chuanhu anti-gout mixture (traditional Chinese Medicine compound', 'placebo', 'Colchicine']","['treatment success', 'reduced inflammation', 'pain, participant global assessment of treatment success', 'Pain and function', 'risk of adverse events', 'adverse events', 'Pain, inflammation and function', 'Reduction of inflammation, function of target joint and withdrawals due to adverse events', 'reduction of inflammation, function of target joint, serious adverse events, total adverse events and withdrawals due to adverse events', 'pain', 'serious adverse events', 'serious adverse', 'number of adverse events', 'pain reduction', 'incidence of total adverse events']","[{'cui': 'C0149896', 'cui_str': 'Primary gout'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0205198', 'cui_str': 'Compound'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",103.0,0.681502,"Reduction of inflammation, function of target joint and withdrawals due to adverse events were not reported in either of these trials, and pain was not reported in the high-dose versus low-dose colchicine trial.","[{'ForeName': 'Bayden J', 'Initials': 'BJ', 'LastName': 'McKenzie', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health, Melbourne, Australia.'}, {'ForeName': 'Mihir D', 'Initials': 'MD', 'LastName': 'Wechalekar', 'Affiliation': 'Rheumatology Unit, Repatriation General Hospital, Daw Park, Australia.'}, {'ForeName': 'Renea V', 'Initials': 'RV', 'LastName': 'Johnston', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health, Melbourne, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Schlesinger', 'Affiliation': 'Division of Rheumatology, Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Buchbinder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health, Melbourne, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006190.pub3']
1434,34440352,Muscle Work and Its Relationship with  ACE  and  ACTN3  Polymorphisms Are Associated with the Improvement of Explosive Strength.,"BACKGROUND


The potential influence of genetics in athletic performance allows the search for genetic profiles associated with muscular work for the orientation of strength training and sports selection. The purpose of the study was to analyze four muscular exercises for effectiveness in improving explosive strength variables, associated to the genetics in Angiotensin Converting Enzyme ( ACE ) and α-actinin-3 ( ACTN3 ) polymorphisms.
METHODS


A randomized controlled trial was conducted on a sample of 80 subjects allocated into four groups: concentric muscle work (CMW), eccentric muscle work (EMW), concentric-eccentric muscle (C-EMW) work and isometric muscular work (IMW), by block and gender randomization. Vertical jump, long jump, power jump, and speed were measured to study explosive strength. Genotypic frequencies of  ACE  (rs4646994) and  ACTN3  (rs1815739) were obtained by polymerase chain reaction.
RESULTS


ACE  gen showed significant improvements regarding the DD genotype in the Sargent test ( p  = 0.003) and sprint velocity test ( p  = 0.017). In the  ACTN3  gene, the RR variable obtained improvement results with regard to RX and XX variables in long jump ( p  < 0.001), Sargent test ( p  < 0.001) and power jump ( p  = 0.004).
CONCLUSIONS


The selected genes demonstrated an influence on the muscle work and the improvement in explosive strength variables with a decisive role regarding the type of muscle work performed.",2021,"RESULTS


ACE  gen showed significant improvements regarding the DD genotype in the Sargent test ( p  = 0.003) and sprint velocity test ( p  = 0.017).",['80 subjects allocated into four groups'],"['concentric muscle work (CMW), eccentric muscle work (EMW), concentric-eccentric muscle (C-EMW) work and isometric muscular work (IMW), by block and gender randomization']","['Vertical jump, long jump, power jump, and speed', 'Genotypic frequencies of  ACE  (rs4646994) and  ACTN3  (rs1815739', 'sprint velocity test']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",80.0,0.0689627,"RESULTS


ACE  gen showed significant improvements regarding the DD genotype in the Sargent test ( p  = 0.003) and sprint velocity test ( p  = 0.017).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Melián Ortiz', 'Affiliation': 'Department of Physical Therapy, FREMAP-Majadahonda Hospital, 28222 Madrid, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Laguarta-Val', 'Affiliation': 'Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine, Faculty of Health Sciences, Rey Juan Carlos University, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Varillas-Delgado', 'Affiliation': 'Department of Sports Sciences, Faculty of Health Sciences, Universidad Francisco de Vitoria, Pozuelo de Alarcon, 28223 Madrid, Spain.'}]",Genes,['10.3390/genes12081177']
1435,34453234,"Efficacy and Safety of Favipiravir in Moderate COVID-19 Pneumonia Patients without Oxygen Therapy: A Randomized, Phase III Clinical Trial.","INTRODUCTION


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), is an enveloped, single-stranded RNA virus. Favipiravir is an orally administrable antiviral drug whose mechanism of action is to selectively inhibit RNA-dependent RNA polymerase. A preliminary trial in COVID-19 patients reported significant improvements across a multitude of clinical parameters, but these findings have not been confirmed in an adequate well-controlled trial. We conducted a randomized, single-blind, placebo-controlled Phase III trial assessing the efficacy and safety of favipiravir in patients with moderate pneumonia not requiring oxygen therapy.
METHODS


COVID-19 patients with moderate pneumonia (SpO 2  ≥ 94%) within 10 days of onset of fever (temperature ≥ 37.5 °C) were assigned to receive either placebo or favipiravir (1800 mg twice a day on Day 1, followed by 800 mg twice a day for up to 13 days) in a ratio of 1:2. An adaptive design was used to re-estimate the sample size. The primary endpoint was a composite outcome defined as the time to improvement in temperature, oxygen saturation levels (SpO 2 ), and findings on chest imaging, and recovery to SARS-CoV-2-negative. This endpoint was re-examined by the Central Committee under blinded conditions.
RESULTS


A total of 156 patients were randomized. The median time of the primary endpoint was 11.9 days in the favipiravir group and 14.7 days in the placebo group, with a significant difference (p = 0.0136). Favipiravir-treated patients with known risk factors such as obesity or coexisting conditions provided better effects. Furthermore, patients with early-onset in the favipiravir group showed higher odds ratio. No deaths were documented. Although adverse events in the favipiravir group were predominantly transient, the incidence was significantly higher.
CONCLUSIONS


The results suggested favipiravir may be one of options for moderate COVID-19 pneumonia treatment. However, the risk of adverse events, including hyperuricemia, should be carefully considered.
TRIAL REGISTRATION


Clinicaltrials.jp number: JapicCTI-205238.",2021,No deaths were documented.,"['patients with moderate pneumonia not requiring oxygen therapy', '156 patients were randomized', 'Moderate COVID-19 Pneumonia Patients without Oxygen Therapy', 'COVID-19 patients with moderate pneumonia (SpO 2']","['placebo or favipiravir', 'placebo', 'favipiravir', 'Favipiravir']","['efficacy and safety', 'Efficacy and Safety', 'median time of the primary endpoint', 'adverse events', 'time to improvement in temperature, oxygen saturation levels (SpO 2 ), and findings on chest imaging, and recovery to SARS-CoV-2-negative', 'onset of fever']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1531652', 'cui_str': 'Chest imaging'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",156.0,0.286017,No deaths were documented.,"[{'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Shinkai', 'Affiliation': 'Department of Respiratory Medicine, Tokyo Shinagawa Hospital, 6-3-22 Higashioi, Shinagawa-ku, Tokyo, 140-8522, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsushima', 'Affiliation': 'Department of Pulmonary Medicine, School of Medicine, International University of Health and Welfare, 852 Hatakeda, Narita, Chiba, 286-8520, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Otolaryngology, Self-Defense Forces Central Hospital, 1-2-24 Ikejiri, Setagaya-ku, Tokyo, 154-8532, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Hagiwara', 'Affiliation': 'Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 6-16-1 Tomiokahigashi, Kanazawa-ku, Yokohama, Kanagawa, 236-0051, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Tarumoto', 'Affiliation': 'Department of Infectious Disease and Infection control, Saitama Medical University Hospital, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Kawada', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Hirai', 'Affiliation': 'Department of Infectious Diseases, Tokyo Medical University Hachioji Medical Center, 1163 Tatemachi, Hachioji, Tokyo, 193-0998, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Infectious Diseases, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Komase', 'Affiliation': 'Department of Respiratory Internal Medicine, St. Marianna University Yokohama City Seibu Hospital, 1197-1 Yasashi-cho, Asahi-ku, Yokohama, Kanagawa, 241-0811, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Saraya', 'Affiliation': 'Department of Respiratory Medicine, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Hidefumi', 'Initials': 'H', 'LastName': 'Koh', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Tachikawa Hospital, 4-2-22 Nishiki-cho, Tachikawa, Tokyo, 190-8531, Japan.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Kagiyama', 'Affiliation': 'Department of Respiratory Medicine, Saitama Cardiovascular and Respiratory Center, 1696 Itai, Kumagaya, Saitama, 360-0197, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Shimada', 'Affiliation': 'Department of General Internal Medicine, Tokai University Oiso Hospital, 21-1 Gakkyo, Oiso-machi, Naka-gun, Kanagawa, 259-0198, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Kanou', 'Affiliation': 'Department of Respiratory Internal Medicine, Yokohama Rosai Hospital, 3211 Kozukue-cho, Kohoku-ku, Yokohama, Kanagawa, 222-0036, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Antoku', 'Affiliation': 'Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, 2-24-18 Higashikoiwa, Edogawa-ku, Tokyo, 133-0052, Japan.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Department of General Medicine, Kitakyushu Municipal Medical Center, 2-1-1 Bashaku, Kokurakita-ku, Kitakyushu, Fukuoka, 802-8561, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Tokue', 'Affiliation': 'Infection Control and Prevention Center, Gunma University Hospital, 3-39-15 Showamachi, Maebashi, Gunma, 371-8511, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Takamori', 'Affiliation': 'Department of Respiratory Medicine, Tokyo Metropolitan Tama Medical Center, 2-8-29 Musashidai, Fuchu, Tokyo, 183-8524, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Gon', 'Affiliation': 'Department of Respiratory Medicine, Nihon University Itabashi Hospital, 30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Ie', 'Affiliation': 'Department of General Internal Medicine, Kawasaki Municipal Tama Hospital, 1-30-37 Shukugawara, Tama-ku, Kawasaki, Kanagawa, 214-8525, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nagano Prefectural Shinshu Medical Center, 1332 Suzaka, Suzaka, Nagano, 382-8577, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Cardiology, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Miyao', 'Affiliation': 'Department of Internal Medicine, Nippon Koukan Hospital, 1-2-1 Kokandori, Kawasaki-ku, Kawasaki, Kanagawa, 210-0852, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Naka', 'Affiliation': 'Department of Neurology, Higashiosaka City Medical Center, 3-4-5 Nishiiwata, Higashiosaka, Osaka, 578-8588, Japan.'}, {'ForeName': 'Mitsunaga', 'Initials': 'M', 'LastName': 'Iwata', 'Affiliation': 'Department of Emergency and General Internal Medicine, Fujita Health University Hospital, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Respiratory Medicine, Kobe City Medical Center General Hospital, 2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Hiyama', 'Affiliation': 'Department of Infectious Diseases, National Hospital Organization Fukuokahigashi Medical Center, 1-1-1 Chidori, Koga, Fukuoka, 811-3195, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Infectious Diseases, Sakai City Medical Center, 1-1-1 Ebarajicho, Nishi-ku, Sakai, Osaka, 593-8304, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shinoda', 'Affiliation': 'Department of Respiratory Medicine, Tokyo Shinagawa Hospital, 6-3-22 Higashioi, Shinagawa-ku, Tokyo, 140-8522, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ota', 'Affiliation': 'Department of Respiratory Medicine, Tokyo Shinagawa Hospital, 6-3-22 Higashioi, Shinagawa-ku, Tokyo, 140-8522, Japan.'}, {'ForeName': 'Takatomo', 'Initials': 'T', 'LastName': 'Hirouchi', 'Affiliation': 'Department of Respiratory Medicine, Tokyo Shinagawa Hospital, 6-3-22 Higashioi, Shinagawa-ku, Tokyo, 140-8522, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Terada', 'Affiliation': 'Department of Pulmonary Medicine, School of Medicine, International University of Health and Welfare, 852 Hatakeda, Narita, Chiba, 286-8520, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Kawano', 'Affiliation': 'Department of Internal Medicine, Self-Defense Forces Central Hospital, 1-2-24 Ikejiri, Setagaya-ku, Tokyo, 154-8532, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogura', 'Affiliation': 'Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 6-16-1 Tomiokahigashi, Kanazawa-ku, Yokohama, Kanagawa, 236-0051, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Sakurai', 'Affiliation': 'Scientific Information Department, FujiFilm Toyama Chemical Co., Ltd., 3-4-8 Hatchobori, Chuo-ku, Tokyo, 104-0032, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Matsumoto', 'Affiliation': 'Scientific Information Department, FujiFilm Toyama Chemical Co., Ltd., 3-4-8 Hatchobori, Chuo-ku, Tokyo, 104-0032, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kunishima', 'Affiliation': 'Department of Infectious Diseases, School of Medicine, St. Marianna University, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Infectious Diseases, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Iwata', 'Affiliation': 'Department of Infectious Diseases, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. siwata@ncc.go.jp.'}]",Infectious diseases and therapy,['10.1007/s40121-021-00517-4']
1436,34455213,Effects of intranasal oxytocin on threat- and reward-related functional connectivity in men and women with and without childhood abuse-related PTSD.,"Novel treatments that target neurobiological alterations associated with childhood trauma, particularly among those with posttraumatic stress disorder (PTSD), could mitigate negative outcomes for these at-risk individuals. PTSD is characterized by abnormalities within the brain's salience network and reward circuitry, which are modulated by intranasal oxytocin. Using a double-blind, randomized, placebo-controlled crossover design, we tested whether intranasal oxytocin (24 international units) influenced functional coupling of the amygdala with the anterior insula (AI), dorsal anterior cingulate cortex, and nucleus accumbens in response to implicitly presented fearful, angry, and happy faces among childhood trauma-exposed individuals with (n = 16, 9 women) and without PTSD (n = 18, 12 women). Psychophysiological interaction analyses revealed that oxytocin effects were limited to amygdala-AI connectivity in the fear condition, distinct for men and women, and not impacted by PTSD diagnosis. In response to fear faces, oxytocin reduced left amygdala-left AI connectivity for women but not men; reduced left amygdala-right AI connectivity among women, but increased this connectivity in men; and reduced right amygdala-right anterior insula connectivity for men, but increased it for women. Results suggest that intranasal oxytocin modulates threat salience among childhood trauma-exposed individuals and that these effects vary as a function of gender and hemisphere.",2021,"In response to fear faces, oxytocin reduced left amygdala-left AI connectivity for women but not men; reduced left amygdala-right AI connectivity among women, but increased this connectivity in men; and reduced right amygdala-right anterior insula connectivity for men, but increased it for women.","['men and women with and without childhood abuse-related PTSD', 'childhood trauma-exposed individuals with (n\xa0=\xa016, 9 women) and without PTSD (n\xa0=\xa018, 12 women']","['oxytocin', 'placebo', 'intranasal oxytocin']","['left amygdala-right AI connectivity', 'left amygdala-left AI connectivity', 'threat- and reward-related functional connectivity', 'right amygdala-right anterior insula connectivity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0441998', 'cui_str': 'Left anterior'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205090', 'cui_str': 'Right'}]",,0.0876802,"In response to fear faces, oxytocin reduced left amygdala-left AI connectivity for women but not men; reduced left amygdala-right AI connectivity among women, but increased this connectivity in men; and reduced right amygdala-right anterior insula connectivity for men, but increased it for women.","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Sippel', 'Affiliation': 'National Center for PTSD, White River Junction, VT, USA; Department of Psychiatry, Geisel School of Medicine at Dartmouth, Hanover, NH, USA. Electronic address: lauren.m.sippel@dartmouth.edu.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Holtzheimer', 'Affiliation': 'National Center for PTSD, White River Junction, VT, USA; Department of Psychiatry, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Moran-Santa-Maria', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Neuroscience, Medical University of South Carolina, Charleston, SC, USA.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2021.111368']
1437,34454710,Voice alerting as a medical alarm modality for next-generation patient monitoring: a randomised international multicentre trial.,"BACKGROUND


Acoustic alarms in medical devices are vital for patient safety. State-of-the-art patient monitoring alarms are indistinguishable and contribute to alarm fatigue. There are two promising new sound modalities for vital sign alarms. Auditory icons convey alarms as brief metaphorical sounds, and voice alerts transmit information using a clear-spoken language. We compared how reliably healthcare professionals identified alarms using these two modalities.
METHODS


This investigator-initiated computer-based multicentre simulation study included 28 anaesthesia providers who were asked to identify vital sign alarms in randomised order, once with voice alerts and once with auditory icons. We further assessed time to decision, diagnostic confidence, and perceived helpfulness. We analysed the results using mixed models, adjusted for possible confounders.
RESULTS


We assessed 14 alarms for each modality, resulting in 392 comparisons across all participants. Compared with auditory icons, healthcare providers had 58 times higher odds of correctly identifying alarms using voice alerts (odds ratio 58.0; 95% confidence interval [CI]: 25.1-133.6; P<0.001), made their decisions about 14 s faster (coefficient -13.9; 95% CI: -15.8 to -12.1 s; P<0.001), perceived higher diagnostic confidence (100% [392 of 392] vs 43% [169 of 392; P<0.001]), and rated voice alerts as more helpful (odds ratio 138.2; 95% CI: 64.9-294.1; P<0.001). The participants were able to identify significantly higher proportions of alarms with voice alerts (98.5%; P<0.001) and auditory icons (54.1%; P<0.001) compared with state-of-the-art alarms (17.9%).
CONCLUSIONS


Voice alerts were superior to auditory icons, and both were superior to current state-of-the-art auditory alarms. These findings demonstrate the potential that voice alerts hold for patient monitoring.",2021,"The participants were able to identify significantly higher proportions of alarms with voice alerts (98.5%; P<0.001) and auditory icons (54.1%; P<0.001) compared with state-of-the-art alarms (17.9%).
","['28 anaesthesia providers who were asked to identify vital sign alarms in randomised order, once with']",['voice alerts and once with auditory icons'],"['time to decision, diagnostic confidence, and perceived helpfulness', 'diagnostic confidence', 'proportions of alarms with voice alerts', 'auditory icons']","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0243020', 'cui_str': 'Immunoconjugate'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0243020', 'cui_str': 'Immunoconjugate'}]",28.0,0.294637,"The participants were able to identify significantly higher proportions of alarms with voice alerts (98.5%; P<0.001) and auditory icons (54.1%; P<0.001) compared with state-of-the-art alarms (17.9%).
","[{'ForeName': 'Tadzio R', 'Initials': 'TR', 'LastName': 'Roche', 'Affiliation': 'Institute of Anaesthesiology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Departments of Epidemiology and Biostatistics, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Ganter', 'Affiliation': 'Institute of Anaesthesiology and Pain Therapy, Cantonal Hospital Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, University of Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Herrmann', 'Affiliation': 'Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, University of Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zacharowski', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Florian J', 'Initials': 'FJ', 'LastName': 'Raimann', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Piekarski', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Donat R', 'Initials': 'DR', 'LastName': 'Spahn', 'Affiliation': 'Institute of Anaesthesiology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christoph B', 'Initials': 'CB', 'LastName': 'Nöthiger', 'Affiliation': 'Institute of Anaesthesiology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Tscholl', 'Affiliation': 'Institute of Anaesthesiology, University of Zurich and University Hospital Zurich, Zurich, Switzerland. Electronic address: david.tscholl@usz.ch.'}, {'ForeName': 'Sadiq', 'Initials': 'S', 'LastName': 'Said', 'Affiliation': 'Institute of Anaesthesiology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.07.015']
1438,34454654,"Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial.","BACKGROUND


Previous studies indicate that isoflurane could be useful for the sedation of patients in the intensive care unit (ICU), but prospective studies evaluating isoflurane's efficacy have been small. The aim of this study was to test whether the sedation with isoflurane was non-inferior to sedation with propofol.
METHODS


This phase 3, randomised, controlled, open-label non-inferiority trial evaluated the efficacy and safety of up to 54 h of isoflurane compared with propofol in adults (aged ≥18 years) who were invasively ventilated in ICUs in Germany (21 sites) and Slovenia (three sites). Patients were randomly assigned (1:1) to isoflurane inhalation via the Sedaconda anaesthetic conserving device (ACD; Sedana Medical AB, Danderyd, Sweden; ACD-L [dead space 100 mL] or ACD-S [dead space 50 mL]) or intravenous propofol infusion (20 mg/mL) for 48 h (range 42-54) using permuted block randomisation with a centralised electronic randomisation system. The primary endpoint was percentage of time in Richmond Agitation-Sedation Scale (RASS) range -1 to -4, assessed in eligible participants with at least 12 h sedation (the per-protocol population), five or more RASS measurements, and no major protocol violations, with a non-inferiority margin of 15%. Key secondary endpoints were opioid requirements, spontaneous breathing, time to wake-up and extubation, and adverse events. Safety was assessed in all patients who received at least one dose. The trial is complete and registered with EudraCT, 2016-004551-67.
FINDINGS


Between July 2, 2017, and Jan 12, 2020, 338 patients were enrolled and 301 (89%) were randomly assigned to isoflurane (n=150) or propofol (n=151). 146 patients (97%) in each group completed the 24-h follow-up. 146 (97%) patients in the isoflurane group and 148 (98%) of patients in the propofol group were included in the per-protocol analysis of the primary endpoint. Least-squares mean percentage of time in RASS target range was 90·7% (95% CI 86·8-94·6) for isoflurane and 91·1% (87·2-95·1) for propofol. With isoflurane sedation, opioid dose intensity was 29% lower than with propofol for the overall sedation period (0·22 [0·12-0·34] vs 0·32 [0·21-0·42] mg/kg per h morphine equivalent dose, p=0·0036) and spontaneous breathing was more frequent on day 1 (odds ratio [OR] 1·72 [1·12-2·64], generalised mixed linear model p=0·013, with estimated rates of 50% of observations with isoflurane vs 37% with propofol). Extubation times were short and median wake-up was significantly faster after isoflurane on day 2 (20 min [IQR 10-30] vs 30 min [11-120]; Cox regression p=0·0011). The most common adverse events by treatment group (isoflurane vs propofol) were: hypertension (ten [7%] of 150 vs two [1%] of 151), delirium (eight [5%] vs seven [5%]), oliguria (seven [5%] vs six [4%]), and atrial fibrillation (five [3%] vs four [3%]).
INTERPRETATION


These results support the use of isoflurane in invasively ventilated patients who have a clinical need for sedation.
FUNDING


Sedana Medical AB.",2021,Extubation times were short and median wake-up was significantly faster after isoflurane on day 2 (20 min [IQR 10-30] vs 30 min [11-120]; Cox regression p=0·0011).,"['adults (aged ≥18 years) who were invasively ventilated in ICUs in Germany (21 sites) and Slovenia (three sites', 'invasively ventilated patients in intensive care units in Germany and Slovenia', 'invasively ventilated patients who have a clinical need for sedation', '146 patients (97%) in each group completed the 24-h follow-up', 'patients in the intensive care unit (ICU', 'Between July 2, 2017, and Jan 12, 2020, 338 patients were enrolled and 301 (89']","['isoflurane', 'Inhaled isoflurane', 'isoflurane inhalation via the Sedaconda anaesthetic conserving device (ACD; Sedana Medical AB, Danderyd, Sweden; ACD-L [dead space 100 mL] or ACD-S [dead space 50 mL]) or intravenous propofol infusion', 'anaesthetic conserving device versus propofol', 'propofol']","['spontaneous breathing', 'efficacy and safety', 'delirium', 'percentage of time in Richmond Agitation-Sedation Scale (RASS) range -1 to -4, assessed in eligible participants with at least 12 h sedation', 'oliguria', 'Extubation times', 'opioid requirements, spontaneous breathing, time to wake-up and extubation, and adverse events', 'Safety', 'hypertension', 'atrial fibrillation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0037334', 'cui_str': 'Slovenia'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0028961', 'cui_str': 'Oliguria'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",338.0,0.064758,Extubation times were short and median wake-up was significantly faster after isoflurane on day 2 (20 min [IQR 10-30] vs 30 min [11-120]; Cox regression p=0·0011).,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meiser', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Therapy, Saarland University Medical Center and Saarland University Faculty of Medicine, Homburg, Germany. Electronic address: andreas.meiser@uks.eu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Volk', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Therapy, Saarland University Medical Center and Saarland University Faculty of Medicine, Homburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wallenborn', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Helios Klinikum Aue, Aue, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Guenther', 'Affiliation': 'University Clinic of Anaesthesiology, Intensive Care, Emergency Medicine, Pain Therapy, Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Becher', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Bracht', 'Affiliation': 'Department of Emergency Medicine, and Department of Anesthesiology and Intensive Care, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Schwarzkopf', 'Affiliation': 'Department of Anesthesia and Intensive Care, Klinikum Saarbrücken, Saarbrücken, Germany.'}, {'ForeName': 'Rihard', 'Initials': 'R', 'LastName': 'Knafelj', 'Affiliation': 'University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Faltlhauser', 'Affiliation': 'Medical Department, Klinikum Weiden, Weiden, Germany.'}, {'ForeName': 'Serge C', 'Initials': 'SC', 'LastName': 'Thal', 'Affiliation': 'Helios University Hospital Wuppertal, University of Witten-Herdecke, Department of Anesthesiology, Wuppertal, Germany; University Medical Center of the Johannes Gutenberg-University Mainz, Department of Anesthesiology, Mainz, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Soukup', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Palliative Care Medicine, Carl-Thiem-Hospital, Cottbus, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kellner', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Lübeck, University Medical Center Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Drüner', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Emden Hospital, Emden, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Vogelsang', 'Affiliation': 'St Josef-Hospital Bochum, Department of Anaesthesiology and Intensive Care Medicine, University Hospital of the Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bellgardt', 'Affiliation': 'St Josef-Hospital Bochum, Department of Anaesthesiology and Intensive Care Medicine, University Hospital of the Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sackey', 'Affiliation': 'Department of Physiology and Pharmacology, Unit of Anesthesiology and Intensive Care, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00323-4']
1439,34461322,Design and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial.,"BACKGROUND


Despite improvement in the standard of care (SOC) for hospitalized COVID-19 patients, rates of morbidity and mortality remain high. There continues to be a need for easily available and cost-effective treatments. Colchicine and rosuvastatin are both safe and well-studied medications with anti-inflammatory and other pleiotropic effects that may provide additional benefits to hospitalized COVID-19 patients.
METHODS AND RESULTS


The Colchicine/Statin for the Prevention of COVID-19 Complications (COLSTAT) trial is a pragmatic, open-label, multicenter, randomized trial comparing the combination of colchicine and rosuvastatin in addition to SOC to SOC alone in hospitalized COVID-19 patients. Four centers in the Yale New Haven Health network will enroll a total of 466 patients with 1:1 randomization. The trial will utilize the electronic health record (Epic® Systems, Verona, Wisconsin, USA) at all stages including screening, randomization, intervention, event ascertainment, and follow-up. The primary endpoint is the 30-day composite of progression to severe COVID-19 disease as defined by the World Health Organization ordinal scale of clinical improvement and arterial/venous thromboembolic events. The secondary powered endpoint is the 30-day composite of death, respiratory failure requiring intubation, and myocardial injury.
CONCLUSIONS


The COLSTAT trial will provide evidence on the efficacy of repurposing colchicine and rosuvastatin for the treatment of hospitalized COVID-19 patients. Moreover, it is designed to be a pragmatic trial that will demonstrate the power of using electronic health records to improve efficiency and enrollment in clinical trials in an adapting landscape.
CLINICAL TRIAL REGISTRATION


NCT04472611 (https://clinicaltrials.gov/ct2/show/NCT04472611).",2021,"The trial will utilize the electronic health record (Epic® Systems, Verona, Wisconsin, USA) at all stages including screening, randomization, intervention, event ascertainment, and follow-up.","['hospitalized COVID-19 patients', 'Four centers in the Yale New Haven Health network will enroll a total of 466 patients with 1:1 randomization']","['Colchicine/Statin', 'Colchicine and rosuvastatin', 'colchicine/statin', 'COLSTAT', 'colchicine and rosuvastatin']","['30-day composite of death, respiratory failure requiring intubation, and myocardial injury', '30-day composite of progression to severe COVID-19 disease as defined by the World Health Organization ordinal scale of clinical improvement and arterial/venous thromboembolic events', 'COVID-19 Complications']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",466.0,0.335721,"The trial will utilize the electronic health record (Epic® Systems, Verona, Wisconsin, USA) at all stages including screening, randomization, intervention, event ascertainment, and follow-up.","[{'ForeName': 'Tayyab', 'Initials': 'T', 'LastName': 'Shah', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'McCarthy', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.'}, {'ForeName': 'Irem', 'Initials': 'I', 'LastName': 'Nasir', 'Affiliation': 'Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.'}, {'ForeName': 'Herb', 'Initials': 'H', 'LastName': 'Archer', 'Affiliation': 'Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Ragheb', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kluger', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Nitu', 'Initials': 'N', 'LastName': 'Kashyap', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Paredes', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Kandel', 'Affiliation': 'Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.'}, {'ForeName': 'Faheem', 'Initials': 'F', 'LastName': 'Ul Haq', 'Affiliation': 'Yale New Haven Health System, CT, United States of America; Bridgeport Hospital, Bridgeport, CT, United States of America.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Howes', 'Affiliation': 'Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cambi', 'Affiliation': 'Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.'}, {'ForeName': 'Gilead', 'Initials': 'G', 'LastName': 'Lancaster', 'Affiliation': 'Yale New Haven Health System, CT, United States of America; Bridgeport Hospital, Bridgeport, CT, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cleman', 'Affiliation': 'Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Dela Cruz', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parise', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lansky', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America. Electronic address: alexandra.lansky@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106547']
1440,34463425,Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials.,"AIM


To evaluate 26 weeks of liraglutide treatment in type 1 diabetes (T1D) by subgroups in the ADJUNCT ONE and ADJUNCT TWO trials.
MATERIALS AND METHODS


ADJUNCT ONE and ADJUNCT TWO were randomized controlled phase 3 trials in 1398 and 835 participants with T1D treated with liraglutide (1.8, 1.2, or 0.6 mg) or placebo (adjuncts to insulin). This post hoc analysis evaluated treatment effects by subgroups: HbA1c (< or ≥8.5%), body mass index (BMI; < or ≥27 kg/m 2  ), and insulin regimen (basal bolus or continuous subcutaneous insulin infusion).
RESULTS


In both trials at week 26, reductions in HbA1c, body weight, and daily insulin dose did not differ significantly (P > .05) by baseline HbA1c or BMI. Risk of clinically significant hypoglycaemia or hyperglycaemia with ketosis did not differ significantly (P > .05) by baseline HbA1c, BMI, or insulin regimen. At week 26 in ADJUNCT ONE, these risks did not differ (P > .05) between treatment groups. Placebo-adjusted reductions in HbA1c, body weight, and insulin dose (-0.30%-points, -5.0 kg, and -12%, respectively, with liraglutide 1.8 mg), were significant (P < .05), greater than at week 52, and similar to those in ADJUNCT TWO (-0.35%, -4.8 kg, and -10%, respectively, with liraglutide 1.8 mg).
CONCLUSIONS


In ADJUNCT ONE and ADJUNCT TWO, the efficacy and glycaemic safety of liraglutide did not depend on subgroups, leaving residual beta-cell function as the only identified variable impacting the effect of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in T1D. These findings support a role for GLP-1 RAs as adjuncts to insulin in T1D, warranting further study.",2021,"In both trials at week 26, reductions in HbA 1c  , body weight and daily insulin dose did not differ significantly (p>0.05) by baseline HbA 1c  or BMI.","['1,398 and 835 participants with T1D treated with', '1.8, 1.2 or 0.6 mg) or']","['insulin regimen (basal bolus or continuous subcutaneous insulin infusion', 'liraglutide', 'placebo (adjuncts to insulin', 'Placebo', 'Liraglutide']","['efficacy and glycemic safety', 'Efficacy and Safety', 'HbA 1c  , body weight and insulin dose', 'reductions in HbA 1c  , body weight and daily insulin dose', 'hypoglycemia or hyperglycemia with ketosis']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C4068883', 'cui_str': '0.6'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}]",,0.252751,"In both trials at week 26, reductions in HbA 1c  , body weight and daily insulin dose did not differ significantly (p>0.05) by baseline HbA 1c  or BMI.","[{'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Dejgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Bernt J', 'Initials': 'BJ', 'LastName': 'von Scholten', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Christiansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Frederik F', 'Initials': 'FF', 'LastName': 'Kreiner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bardtrum', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'von Herrath', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Hvidovre University Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.14532']
1441,34462887,Knee Osteoarthritis Pain Management with an Innovative High and Low Molecular Weight Hyaluronic Acid Formulation (HA-HL): A Randomized Clinical Trial.,"INTRODUCTION


The objective of this study was to compare a single intra-articular injection of an innovative high and low molecular weight hyaluronic acid formulation (HA-HL) versus placebo in treating moderate-to-severe symptomatic knee osteoarthritis.
METHODS


Subjects with primary osteoarthritis knee pain (Kellgren and Lawrence grade 2-3) were randomly assigned to intra-articular HA-HL or placebo in a prospective, double-blind, 24-week study. The primary outcome variable was change from screening to week 24 of a Visual Analogue Scale (VAS) pain score. Secondary outcomes included Lequesne's algofunctional index, EuroQol 5-Dimension Questionnaire, 5-level version (EQ-5D-5L), Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) response and rescue medication usage.
RESULTS


In a total of 692 randomized patients, a rapid decrease was observed in mean VAS pain score from baseline to week 1 (26 ± 24 mm in the HA-HL group vs. 23 ± 23 mm in the placebo group); pain intensity continued to decrease during 24 weeks of follow-up, reaching a mean change from baseline of 35 ± 28 mm vs. 32 ± 27 mm at week 24. Mixed model analysis demonstrated statistically significant differences between groups in favor of the HA-HL group at weeks 1, 6, 12, and 24. HA-HL was also more effective than placebo in improving Lequesne's algofunctional index, OMERACT-OARSI response, and health-related quality of life. The use of rescue medication (paracetamol 500 mg tablets; ≤ 6 per day) was lower in the HA-HL group. Both treatments were similarly well tolerated.
CONCLUSIONS


A single intra-articular injection of an innovative high and low molecular weight hyaluronic acid formulation (HA-HL) is effective in providing fast, sustained, and clinically relevant reductions in pain, functional limitation, and health-related quality of life that were apparent at 1 week after the intra-articular injection and maintained throughout the 24-week follow-up in subjects with painful knee osteoarthritis, with a good safety profile.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03200288.",2021,"HA-HL was also more effective than placebo in improving Lequesne's algofunctional index, OMERACT-OARSI response, and health-related quality of life.",['Subjects with primary osteoarthritis knee pain (Kellgren and Lawrence grade 2-3'],"['innovative high and low molecular weight hyaluronic acid formulation (HA-HL', 'Innovative High and Low Molecular Weight Hyaluronic Acid Formulation (HA-HL', 'intra-articular HA-HL or placebo', 'placebo', 'rescue medication (paracetamol']","['mean VAS pain score', 'pain intensity', 'tolerated', 'change from screening to week 24 of a Visual Analogue Scale (VAS) pain score', ""Lequesne's algofunctional index, EuroQol 5-Dimension Questionnaire, 5-level version (EQ-5D-5L), Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) response and rescue medication usage"", ""Lequesne's algofunctional index, OMERACT-OARSI response, and health-related quality of life""]","[{'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451868', 'cui_str': 'Localized osteoporosis - Lequesne'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",692.0,0.187964,"HA-HL was also more effective than placebo in improving Lequesne's algofunctional index, OMERACT-OARSI response, and health-related quality of life.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Migliore', 'Affiliation': 'Rheumatology Unit, S. Pietro FBF Hospital, Via Cassia 600, 00189, Rome, Italy. migliore.alberto60@gmail.com.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Blicharski', 'Affiliation': 'Chair and Department of Rehabilitation and Orthopaedics, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Plebanski', 'Affiliation': 'Klinika Zdrowej Kości, Lodz, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Zegota', 'Affiliation': 'SOLB, Zbigniew Zegota, Ostroda, Poland.'}, {'ForeName': 'Győrfi', 'Initials': 'G', 'LastName': 'Gyula', 'Affiliation': 'Swan Med Hungary Kft, Létavértes, Hungary.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Rannou', 'Affiliation': 'Faculté de Médecine Paris Descartes, Université de Paris, Sorbonne Paris Cité, 75006, Paris, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'Division of Public Health, Epidemiology and Health Economics, University of Liège, Liège, Belgium.'}]",Rheumatology and therapy,['10.1007/s40744-021-00363-3']
1442,34462881,Association Between Spreading Depolarization and Delayed Cerebral Ischemia After Subarachnoid Hemorrhage: Post Hoc Analysis of a Randomized Trial of the Effect of Cilostazol on Delayed Cerebral Ischemia.,"BACKGROUND


Delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH) remains an important problem with a complex pathophysiology. We used data from a single-center randomized trial to assess the effect of a phosphodiesterase inhibitor, cilostazol, in patients with aneurysmal SAH to explore the relationships of DCI with vasospasm, spreading depolarization (SD) and microcirculatory disturbance.
METHODS


A post hoc analysis of a single-center, prospective, randomized trial of the effect of cilostazol on DCI and SD after aneurysmal SAH was performed. From all randomized cohorts, patients who underwent both SD monitoring and digital subtraction angiography (DSA) on day 9 ± 2 from onset were included. Cerebral circulation time (CCT), which was divided into proximal CCT and peripheral CCT (as a measure of microcirculatory disturbance), was obtained from DSA. Logistic regression was conducted to determine factors associated with DCI.
RESULTS


Complete data were available for 28 of 50 patients. Of the 28 patients, 8 (28.5%) had DCI during the study period. Multivariate analysis indicated a strong association between the number of SDs on the day DSA was performed (i.e., a delayed time point after SAH onset) and DCI (odds ratio 2.064, 95% confidence interval 1.045-4.075, P = 0.037, area under the curve 0.836), whereas the degree of angiographic vasospasm and peripheral CCT were not significant factors for DCI.
CONCLUSIONS


There is a strong association between SD and DCI. Our results suggest that SD is an important therapeutic target and a potentially useful biomarker for DCI.",2021,"Multivariate analysis indicated a strong association between the number of SDs on the day DSA was performed (i.e., a delayed time point after SAH onset) and DCI (odds ratio 2.064, 95% confidence interval 1.045-4.075, P = 0.037, area under the curve 0.836), whereas the degree of angiographic vasospasm and peripheral CCT were not significant factors for DCI.
","['patients who underwent both SD monitoring and digital subtraction angiography (DSA) on day 9\u2009±\u20092 from onset were included', 'patients with aneurysmal SAH to explore the relationships of DCI with vasospasm, spreading depolarization (SD) and microcirculatory disturbance', 'Delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH', 'After Subarachnoid Hemorrhage']","['Cilostazol', 'cilostazol', 'phosphodiesterase inhibitor, cilostazol']","['degree of angiographic vasospasm and peripheral CCT', 'Delayed Cerebral Ischemia', 'Cerebral circulation time (CCT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}]","[{'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0031638', 'cui_str': 'Phosphodiesterase inhibitor'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}]",,0.057498,"Multivariate analysis indicated a strong association between the number of SDs on the day DSA was performed (i.e., a delayed time point after SAH onset) and DCI (odds ratio 2.064, 95% confidence interval 1.045-4.075, P = 0.037, area under the curve 0.836), whereas the degree of angiographic vasospasm and peripheral CCT were not significant factors for DCI.
","[{'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Kawano', 'Affiliation': 'Department of Neurosurgery, Yamaguchi University School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Neurosurgery, Yamaguchi University School of Medicine, Yamaguchi, Japan. sugi1010@yamaguchi-u.ac.jp.'}, {'ForeName': 'Sadahiro', 'Initials': 'S', 'LastName': 'Nomura', 'Affiliation': 'Department of Neurosurgery, Yamaguchi University School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Neurosurgery, Yamaguchi University School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Reo', 'Initials': 'R', 'LastName': 'Kawano', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Oka', 'Affiliation': 'Department of Neurosurgery, Yamaguchi University School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Sadahiro', 'Affiliation': 'Department of Neurosurgery, Yamaguchi University School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ishihara', 'Affiliation': 'Department of Neurosurgery, Yamaguchi University School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Michiyasu', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Neurosurgery, Yamaguchi University School of Medicine, Yamaguchi, Japan.'}]",Neurocritical care,['10.1007/s12028-021-01330-0']
1443,34472698,"Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A post hoc subgroup analysis of the PIONEER 1, 3, 4 and 8 trials.","AIMS


To evaluate, through exploratory post hoc subgroup analyses, the efficacy and safety of oral semaglutide versus comparators in Japanese patients enrolled in the global PIONEER 1, 3, 4 and 8 clinical trials.
MATERIALS AND METHODS


Patients were randomized to once-daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg). Change from baseline in glycated haemoglobin (HbA1c) and body weight, and proportions of patients attaining HbA1c <7.0% (53 mmol/mol) and body weight loss ≥5%, were analysed at week 26 for all Japanese patients in each trial separately using the treatment policy estimand (regardless of treatment discontinuation or rescue medication use). Adverse events (AEs) were analysed descriptively.
RESULTS


Reductions in HbA1c from baseline in Japanese patients were 1.0% to 1.2% (11.3 mmol/mol to 13.3 mmol/mol) and 1.4% to 1.7% (15.7 mmol/mol to 18.3 mmol/mol) for oral semaglutide 7 mg and 14 mg, respectively. HbA1c reductions were similar or greater than with comparators. Body weight reductions were 1.0% to 2.7% and 3.7% to 4.7% for oral semaglutide 7 mg and 14 mg, respectively, and were generally greater with oral semaglutide than comparators. As expected, the main class of AEs was gastrointestinal, and these AEs comprised most commonly mild-to-moderate constipation, nausea and diarrhoea.
CONCLUSIONS


Oral semaglutide appears efficacious and well tolerated in Japanese patients across the type 2 diabetes spectrum.",2021,"Body weight reductions were 1.0-2.7% and 3.7-4.7% for oral semaglutide 7 and 14 mg, respectively, and were generally greater with oral semaglutide than comparators.","['Patients', 'Japanese patients enrolled in the global PIONEER 1, 3, 4 and 8 clinical trials', 'Japanese patients with type 2 diabetes', 'adults with type 2 diabetes (T2D) in Japan', 'Japanese patients across the T2D spectrum']","['oral semaglutide', 'glucagon-like peptide-1 receptor agonist, oral semaglutide', 'daily oral semaglutide 3, 7 or 14 mg or comparator (placebo, sitagliptin 100 mg or liraglutide']","['glycated haemoglobin (HbA1c) and body weight, and proportions', 'efficacy and safety', 'Efficacy and safety', 'Adverse events (AEs', 'Body weight reductions', 'HbA1c reductions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.139643,"Body weight reductions were 1.0-2.7% and 3.7-4.7% for oral semaglutide 7 and 14 mg, respectively, and were generally greater with oral semaglutide than comparators.","[{'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': 'Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Terauchi', 'Affiliation': 'Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Deenadayalan', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Christiansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Horio', 'Affiliation': 'Novo Nordisk Pharma Ltd, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kadowaki', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14536']
1444,34472676,Effectiveness of an optimized text message and Internet intervention for smoking cessation: A randomized controlled trial.,"AIMS


To evaluate the effectiveness of a combined internet and text message intervention for smoking cessation compared with an internet intervention alone. The text message intervention was optimized for engagement in an earlier multiphase optimization (MOST) screening phase.
DESIGN


A parallel, two-group, individually randomized clinical trial (RCT) was conducted in a MOST confirming phase. Recruitment spanned December 2018 to March 2019. Follow-up was conducted at 3 and 9 months, beginning March 2019 and ending January 2020.
SETTING


United States: a digital study conducted among new registrants on a free tobacco cessation website.
PARTICIPANTS


Eligible individuals were 618 adult current smokers in the United States, age 18 years or older who signed up for text messages during website registration (67.2% female, 70.4% white).
INTERVENTIONS


The treatment arm (WEB+TXT; n = 311) received access to the website and text messaging. The control arm (WEB; n = 307) received access to the website alone.
MEASUREMENTS


The primary outcome was self-reported 30-day point prevalence abstinence (ppa) at 9 months post-randomization analyzed under intent to treat (ITT), counting non-responders as smoking. Secondary outcomes included 3-month measures of 30-day ppa, intervention engagement and intervention satisfaction.
FINDINGS


Abstinence rates at 9 months were 23.1% among WEB+TXT and 23.2% among WEB (OR = 1.00, 95% CI = 0.69-1.45; P = 0.99). WEB+TXT increased engagement with 5 of 6 interactive features (standardized mean difference (SMD) = 0.26-0.47, all P < 0.001) and repeat website visits (48.7% vs 38.9%, SMD = 0.14, P = 0.02). Satisfaction metrics favored WEB+TXT (satisfied: 96.3% vs 90.5%, SMD = 0.17, P = 0.008; recommend to friend: 95.9% vs 90.1%, SMD = 0.16, P = 0.028).
CONCLUSIONS


A randomized controlled trial found no evidence that a combined internet and text message intervention for smoking cessation compared with an internet intervention alone increased 9-month abstinence rates among adult current smokers in the United States, despite evidence of higher levels of intervention engagement and satisfaction at 3 months.",2021,"WEB+TXT increased engagement with 5 of 6 interactive features (Standardized Mean Difference (SMD)=.26-.47, all p<.001) and repeat website visits (48.7% vs 38.9%, SMD=.14, p=.02).","['Eligible individuals were 618 adult current smokers in the U.S., age 18 years or older who signed up for text messages during website registration (67.2% female, 70.4% white', 'United States: a digital study conducted among new registrants on a free tobacco cessation website', 'adult current smokers', 'smoking cessation']","['Internet intervention alone', 'access to the website alone', 'WEB+TXT', 'combined Internet and text message intervention', 'optimized text message and Internet intervention']","['3-month measures of 30-day ppa, intervention engagement and intervention satisfaction', '9-month abstinence rates', 'repeat website visits', 'Abstinence rates', 'self-reported 30-day point prevalence abstinence (ppa) at 9 months post-randomization analyzed under intent to treat (ITT), counting non-responders as smoking']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]",,0.240828,"WEB+TXT increased engagement with 5 of 6 interactive features (Standardized Mean Difference (SMD)=.26-.47, all p<.001) and repeat website visits (48.7% vs 38.9%, SMD=.14, p=.02).","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Graham', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Papandonatos', 'Affiliation': 'Center for Statistical Sciences, Brown University, Providence, RI, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cha', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Amato', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Jacobs', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Cohn', 'Affiliation': 'Health Promotion Research Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Lorien C', 'Initials': 'LC', 'LastName': 'Abroms', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}]","Addiction (Abingdon, England)",['10.1111/add.15677']
1445,34455287,A theory-based adaptive E-learning program aimed at increasing intentions to provide brief behavior change counseling: Randomized controlled trial.,"BACKGROUND


Unhealthy behaviors are significant contributors to non-communicable diseases. Nurses can support patient health behavior change by providing brief behavior change counseling. However, training programs in brief counseling are generally not personalized, or adapted, to the barriers and theoretical determinants of its provision in clinical practice.
OBJECTIVE


This study aimed to evaluate the effectiveness of the E_MOTIV A  theory-based adaptive e-learning program on nurses' and nursing students' intentions to provide brief counseling for smoking, unhealthy eating habits and medication nonadherence.
DESIGN AND METHODS


A randomized controlled trial was conducted with nurses and nursing students in Canada. Experimental group participants were allocated to the E_MOTIV A  theory-based adaptive e-learning program. Control group participants were allocated to the E_MOTIV B  knowledge-based standardized e-learning program. E_MOTIV A  was designed to influence the constructs of the Theory of Planned Behavior (e.g., attitude, subjective norms) in relation to brief counseling. Outcomes were improvement in intention to provide brief counseling, improvement in other Theory of Planned Behavior variables, as well as cognitive load and engagement related to e-learning.
RESULTS


A total of 102 participants were randomized to the experimental (n = 51) and control (n = 51) groups. End of study questionnaires were completed by 27 experimental group and 38 control group participants. Analyses indicated no significant differences between groups in the change of scores for intention to provide brief counseling. However, while not significant, the change of score was greater in the experimental group (10.22 ± 3.34 versus 9.04 ± 2.80; p = 0.787). Scores in both groups improved significantly for attitude, subjective norms, perceived behavioral control, behavioral beliefs, and control beliefs. However, there were no statistically significant differences between groups for these variables as well as for cognitive load and engagement.
CONCLUSIONS


Both e-learning programs had a similar positive effect on nurses' and nursing students' intentions to provide brief counseling and on Theory of Planned Behavior variables.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN32603572; http://www.isrctn.com/ISRCTN32603572.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/18894; https://doi.org/10.2196/18894.",2021,"Both e-learning programs had a similar positive effect on nurses' and nursing students' intentions to provide brief counseling and on Theory of Planned Behavior variables.
","['nurses and nursing students in Canada', '102 participants', ""nurses' and nursing students' intentions""]",['theory-based adaptive e-learning program'],"['attitude, subjective norms, perceived behavioral control, behavioral beliefs, and control beliefs', 'intention to provide brief counseling, improvement in other Theory of Planned Behavior variables, as well as cognitive load and engagement related to e-learning', 'cognitive load and engagement', 'change of score']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",102.0,0.0558633,"Both e-learning programs had a similar positive effect on nurses' and nursing students' intentions to provide brief counseling and on Theory of Planned Behavior variables.
","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Fontaine', 'Affiliation': 'Faculty of Nursing, Université de Montréal, 2375 Chemin de la Côte-Sainte-Catherine, Montréal, QC H3T 1A8, Canada; Montreal Heart Institute Research Center, 5000 Bélanger, Montréal, QC H1T 1C8, Canada. Electronic address: guillaume.fontaine@umontreal.ca.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Cossette', 'Affiliation': 'Faculty of Nursing, Université de Montréal, 2375 Chemin de la Côte-Sainte-Catherine, Montréal, QC H3T 1A8, Canada; Montreal Heart Institute Research Center, 5000 Bélanger, Montréal, QC H1T 1C8, Canada. Electronic address: sylvie.cossette.inf@umontreal.ca.'}]",Nurse education today,['10.1016/j.nedt.2021.105112']
1446,34455218,The effect of Origanum majorana tea on motor and non-motor symptoms in patients with idiopathic Parkinson's disease: A randomized controlled pilot study.,"AIMS


The effect of Origanum majorana tea consumption on motor and non-motor symptoms was investigated in patients with idiopathic Parkinson's disease, measured by validated tools.
METHODS


Sixty patients with idiopathic Parkinson's disease and under conventional medication were enrolled voluntarily in the study. All participants were randomized on double-blind to placebo or Origanum majorana. Clinical assessment with validated tools (UPDRSIII, NMSS, and BDI) was done before Origanum majorana or placebo consumption (Day 0) and at the end of the experiment (Day 30).
RESULTS


The treatment groups were similar at baseline on demographic and clinical variables. During the course of study, nine participants withdrew for reasons of noncompliance and inability to follow-up. Fifty-one participants completed the study. Upon completion of 30 days of treatment, Origanum majorana tea consumption did not decrease the UPDRSIII score ([UPDRSIII ]  D0 = 18.76 ± 8.58, D30 = 16.52 ± 7.96, p = 0.069) at the p value was 0.07. However, a statistically significant improvement was noted in NMSS and BDI scores (p < 0.0001 and p < 0.0001, respectively). Assessment of the UPDRSIII, NMSS and BDI scores of the patients did not reflect any improvement with placebo. No side effect was detected during the study .  CONCLUSION: These findings show improvement of depressive and non-motor signs in patients with Parkinson's disease in the group that consumed Origanum majorana tea in combination with conventional therapy. Improvement of motor signs may need an extended treatment period. However, more research with a large number of participants and lasting longer than 1 month is needed to argue these findings.",2021,"Assessment of the UPDRSIII, NMSS and BDI scores of the patients did not reflect any improvement with placebo.","['Fifty-one participants completed the study', ""patients with idiopathic Parkinson's disease, measured by validated tools"", ""Sixty patients with idiopathic Parkinson's disease and under conventional medication were enrolled voluntarily in the study"", ""patients with idiopathic Parkinson's disease"", ""patients with Parkinson's disease""]","['Origanum majorana tea consumption', 'Origanum majorana tea', 'placebo or Origanum majorana', 'placebo']","['UPDRSIII score', 'UPDRSIII, NMSS and BDI scores', 'NMSS and BDI scores', 'depressive and non-motor signs', 'side effect', 'motor and non-motor symptoms']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C1445344', 'cui_str': 'Origanum majorana extract'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}]",60.0,0.351525,"Assessment of the UPDRSIII, NMSS and BDI scores of the patients did not reflect any improvement with placebo.","[{'ForeName': 'Chbili', 'Initials': 'C', 'LastName': 'Chahra', 'Affiliation': 'Metabolic Biophysics and Applied Pharmacology Laboratory, Faculty of Medicine Ibn El Jazzar Sousse, Sousse University, Tunisia; University of Sousse, Faculty of Medicine Ibn El Jazzar, Sousse, Tunisia. Electronic address: chahrachbili@yahoo.fr.'}, {'ForeName': 'Hassine', 'Initials': 'H', 'LastName': 'Anis', 'Affiliation': 'Neurology Department, Sahloul Teaching Hospital, Sousse, Tunisia; University of Sousse, Faculty of Medicine Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Douma', 'Initials': 'D', 'LastName': 'Bissene', 'Affiliation': 'Neurology Department, Sahloul Teaching Hospital, Sousse, Tunisia; University of Sousse, Faculty of Medicine Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Selmi', 'Initials': 'S', 'LastName': 'Mejda', 'Affiliation': 'Metabolic Biophysics and Applied Pharmacology Laboratory, Faculty of Medicine Ibn El Jazzar Sousse, Sousse University, Tunisia; University of Sousse, Faculty of Medicine Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Maatoug', 'Initials': 'M', 'LastName': 'Jihène', 'Affiliation': 'Department of Epidemiology, University Hospital Farhat Hached, Sousse, Tunisia; University of Sousse, Faculty of Medicine Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Naija', 'Initials': 'N', 'LastName': 'Salma', 'Affiliation': 'Neurology Department, Sahloul Teaching Hospital, Sousse, Tunisia; University of Sousse, Faculty of Medicine Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Nouira', 'Initials': 'N', 'LastName': 'Manel', 'Affiliation': 'Metabolic Biophysics and Applied Pharmacology Laboratory, Faculty of Medicine Ibn El Jazzar Sousse, Sousse University, Tunisia; University of Sousse, Faculty of Medicine Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Ben Amor', 'Initials': 'BA', 'LastName': 'Sana', 'Affiliation': 'Neurology Department, Sahloul Teaching Hospital, Sousse, Tunisia; University of Sousse, Faculty of Medicine Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Khairi', 'Initials': 'K', 'LastName': 'Hedi', 'Affiliation': 'University of Sousse, Faculty of Medicine Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Ben Fredj', 'Initials': 'BF', 'LastName': 'Maha', 'Affiliation': 'Metabolic Biophysics and Applied Pharmacology Laboratory, Faculty of Medicine Ibn El Jazzar Sousse, Sousse University, Tunisia; University of Sousse, Faculty of Medicine Ibn El Jazzar, Sousse, Tunisia.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2021.08.013']
1447,34460132,"Melatonin effects on sleep quality and outcomes of COVID-19 patients: An open-label, randomized, controlled trial.","This trial aims to evaluate the effectiveness of adding melatonin to the treatment protocol of hospitalized coronavirus disease 2019 (COVID-19) patients. This was an open-label, randomized controlled clinical trial in hospitalized COVID-19 patients. Patients were randomized into a treatment arm receiving melatonin plus standard care or a control arm receiving standard care alone. The trial's primary endpoint was sleep quality examined by the Leeds Sleep Evaluation Questionnaire (LSEQ). The trial's secondary endpoints were symptoms alleviation by Day 7, intensive care unit admission, 10-day mortality, white blood cell count, lymphocyte count, C-reactive protein status, and peripheral capillary oxygen saturation. Ninety-six patients were recruited and allocated to either the melatonin arm (n = 48) or control arm (n = 48). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms on Day 7. The mean of the LSEQ scores was significantly higher in the melatonin group (p < 0.001). There was no significant difference in laboratory data, except for blood oxygen saturation, which has improved significantly in the melatonin group compared with the control group (95.81% vs. 93.65% respectively, p = 0.003). This clinical trial study showed that the combination of oral melatonin tablets and standard treatment could substantially improve sleep quality and blood oxygen saturation in hospitalized COVID-19 patients.",2022,"There was no significant difference in laboratory data, except for blood oxygen saturation, which has improved significantly in the melatonin group compared to the control group (95.81% vs. 93.65% respectively, p=0.003).
","['Ninety-six patients', 'hospitalized COVID-19 patients', 'arm (n=48) or control arm (n=48', 'COVID-19 patients']","['melatonin', 'melatonin plus standard care or a control arm receiving standard care alone', 'Melatonin', 'oral melatonin tablets']","['mean of the LSEQ scores', 'laboratory data', 'symptoms alleviation by day seven, ICU admission, ten-day mortality, white blood cell count, lymphocyte count, C-reactive protein status, and peripheral capillary oxygen saturation', 'sleep quality and blood oxygen saturation', 'sleep quality examined by the Leeds Sleep Evaluation Questionnaire (LSEQ', 'sleep quality', 'blood oxygen saturation']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]",96.0,0.206219,"There was no significant difference in laboratory data, except for blood oxygen saturation, which has improved significantly in the melatonin group compared to the control group (95.81% vs. 93.65% respectively, p=0.003).
","[{'ForeName': 'Seyed Abbas', 'Initials': 'SA', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychiatry, Psychiatry and Behavioral Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Heydari', 'Affiliation': 'Gastrointestinal Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Mehravaran', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Internal Medicine, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Pharmaceutical Sciences Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Alizadeh-Navaei', 'Affiliation': 'Gastrointestinal Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hedayatizadeh-Omran', 'Affiliation': 'Gastrointestinal Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Shamshirian', 'Affiliation': 'Gastrointestinal Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}]",Journal of medical virology,['10.1002/jmv.27312']
1448,34460089,"Correction to: Repository Corticotropin Injection for Persistently Active Systemic Lupus Erythematosus: Results from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.",,2021,,['Persistently Active Systemic Lupus Erythematosus'],"['Repository Corticotropin Injection', 'Placebo']",[],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}]","[{'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.882552,,"[{'ForeName': 'Anca D', 'Initials': 'AD', 'LastName': 'Askanase', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA. ada20@cumc.columbia.edu.'}, {'ForeName': 'Enxu', 'Initials': 'E', 'LastName': 'Zhao', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Bilyk', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Furie', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}]",Rheumatology and therapy,['10.1007/s40744-021-00353-5']
1449,34460083,Reversal of SARS-CoV2-Induced Hypoxia by Nebulized Sodium Ibuprofenate in a Compassionate Use Program.,"INTRODUCTION


Sodium ibuprofenate in hypertonic saline (NaIHS) administered directly to the lungs by nebulization and inhalation has antibacterial and anti-inflammatory effects, with the potential to deliver these benefits to hypoxic patients. We describe a compassionate use program that offered this therapy to hospitalized COVID-19 patients.
METHODS


NaIHS (50 mg ibuprofen, tid) was provided in addition to standard of care (SOC) to hospitalized COVID-19 patients until oxygen saturation levels of > 94% were achieved on ambient air. Patients wore a containment hood to diminish aerosolization. Outcome data from participating patients treated at multiple hospitals in Argentina between April 4 and October 31, 2020, are summarized. Results were compared with a retrospective contemporaneous control (CC) group of hospitalized COVID-19 patients with SOC alone during the same time frame from a subset of participating hospitals from Córdoba and Buenos Aires.
RESULTS


The evolution of 383 patients treated with SOC + NaIHS [56 on mechanical ventilation (MV) at baseline] and 195 CC (21 on MV at baseline) are summarized. At baseline, NaIHS-treated patients had basal oxygen saturation of 90.7 ± 0.2% (74.3% were on supplemental oxygen at baseline) and a basal respiratory rate of 22.7 ± 0.3 breath/min. In the CC group, basal oxygen saturation was 92.6 ± 0.4% (52.1% were on oxygen supplementation at baseline) and respiratory rate was 19.3 ± 0.3 breath/min. Despite greater pulmonary compromise at baseline in the NaIHS-treated group, the length of treatment (LOT) was 9.1 ± 0.2 gs with an average length of stay (ALOS) of 11.5 ± 0.3 days, in comparison with an ALOS of 13.3 ± 0.9 days in the CC group. In patients on MV who received NaIHS, the ALOS was lower than in the CC group. In both NaIHS-treated groups, a rapid reversal of deterioration in oxygenation and NEWS2 scores was observed acutely after initiation of NaIHS therapy. No serious adverse events were considered related to ibuprofen therapy. Mortality was lower in both NaIHS groups compared with CC groups.
CONCLUSIONS


Treatment of COVID-19 pneumonitis with inhalational nebulized NaIHS was associated with rapid improvement in hypoxia and vital signs, with no serious adverse events attributed to therapy. Nebulized NaIHS s worthy of further study in randomized, placebo-controlled trials (ClinicalTrials.gov: NCT04382768).",2021,"Mortality was lower in both NaIHS groups compared with CC groups.
","['hospitalized COVID-19 patients', 'participating patients treated at multiple hospitals in Argentina between April 4 and October 31, 2020, are summarized', '383 patients treated with']","['ibuprofen, tid', 'Nebulized Sodium Ibuprofenate', 'SOC\xa0+\xa0NaIHS [56 on mechanical ventilation (MV', 'hypertonic saline (NaIHS', 'placebo']","['rapid reversal of deterioration in oxygenation and NEWS2 scores', 'pulmonary compromise', 'hypoxia and vital signs', 'Mortality', 'ALOS', 'basal oxygen saturation', 'serious adverse events', 'respiratory rate']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",,0.0868195,"Mortality was lower in both NaIHS groups compared with CC groups.
","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Salva', 'Affiliation': 'Clínica Independencia, Munro, Buenos Aires, Argentina.'}, {'ForeName': 'Pablo A', 'Initials': 'PA', 'LastName': 'Doreski', 'Affiliation': 'Fundación Respirar, Belgrano, Buenos Aires, Argentina.'}, {'ForeName': 'Celia S', 'Initials': 'CS', 'LastName': 'Giler', 'Affiliation': 'Clínica Independencia, Munro, Buenos Aires, Argentina.'}, {'ForeName': 'Dario C', 'Initials': 'DC', 'LastName': 'Quinodoz', 'Affiliation': 'Sanatorio de la Cañada, Villa Maria, Córdoba, Argentina.'}, {'ForeName': 'Lucia G', 'Initials': 'LG', 'LastName': 'Guzmán', 'Affiliation': 'Sanatorio de la Cañada, Villa Maria, Córdoba, Argentina.'}, {'ForeName': 'Sonia E', 'Initials': 'SE', 'LastName': 'Muñoz', 'Affiliation': 'Instituto de Investigaciones en Ciencias de la Salud, Ciudad Universitaria, Córdoba, Argentina.'}, {'ForeName': 'Mariana N', 'Initials': 'MN', 'LastName': 'Carrillo', 'Affiliation': 'Instituto de Investigaciones en Ciencias de la Salud, Ciudad Universitaria, Córdoba, Argentina.'}, {'ForeName': 'Daniela J', 'Initials': 'DJ', 'LastName': 'Porta', 'Affiliation': 'Instituto de Investigaciones en Ciencias de la Salud, Ciudad Universitaria, Córdoba, Argentina.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Ambasch', 'Affiliation': 'Sanatorio Mayo Privado SA, Ciudad de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Coscia', 'Affiliation': 'Sanatorio Mayo Privado SA, Ciudad de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Jorge L Tambini', 'Initials': 'JLT', 'LastName': 'Diaz', 'Affiliation': 'Sanatorio Mayo Privado SA, Ciudad de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Germán D', 'Initials': 'GD', 'LastName': 'Bueno', 'Affiliation': 'Sanatorio Mayo Privado SA, Ciudad de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Jorge O', 'Initials': 'JO', 'LastName': 'Fandi', 'Affiliation': 'Clínica Independencia, Munro, Buenos Aires, Argentina.'}, {'ForeName': 'Miriam A', 'Initials': 'MA', 'LastName': 'Maldonado', 'Affiliation': 'Hospital San Roque, Ciudad de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Leandro E', 'Initials': 'LE', 'LastName': 'Peña Chiappero', 'Affiliation': 'Hospital San Roque, Ciudad de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Fournier', 'Affiliation': 'Clínica Francesa, Ciudad de Mendoza, Mendoza, Argentina.'}, {'ForeName': 'Hernán A', 'Initials': 'HA', 'LastName': 'Pérez', 'Affiliation': 'Sanatorio Alive, Ciudad de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Mauro A', 'Initials': 'MA', 'LastName': 'Quiroga', 'Affiliation': 'Instituto Modelo de Cardiología, Ciudad de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Sala Mercado', 'Affiliation': 'Instituto Modelo de Cardiología, Ciudad de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Martínez Picco', 'Affiliation': 'Clínica del Sol, Ciudad de Rivadavia, Mendoza, Argentina.'}, {'ForeName': 'Marcelo Alejandro', 'Initials': 'MA', 'LastName': 'Beltrán', 'Affiliation': 'Hospital Dr. Alberto Duhau, José C Paz, Buenos Aires, Argentina.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Argañarás', 'Affiliation': 'Química Luar SRL, Ciudad de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Nicolás Martínez', 'Initials': 'NM', 'LastName': 'Ríos', 'Affiliation': 'Química Luar SRL, Ciudad de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Galia I', 'Initials': 'GI', 'LastName': 'Kalayan', 'Affiliation': 'CEPROCOR, Ciudad de Santa María de Punilla, Córdoba, Argentina.'}, {'ForeName': 'Dante M', 'Initials': 'DM', 'LastName': 'Beltramo', 'Affiliation': 'CEPROCOR, Ciudad de Santa María de Punilla, Córdoba, Argentina.'}, {'ForeName': 'Néstor H', 'Initials': 'NH', 'LastName': 'García', 'Affiliation': 'Instituto de Investigaciones en Ciencias de la Salud, Ciudad Universitaria, Córdoba, Argentina. garcia.nestor@conicet.gov.ar.'}]",Infectious diseases and therapy,['10.1007/s40121-021-00527-2']
1450,34461042,Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial.,"BACKGROUND


Previous studies have suggested that haemodynamic-guided management using an implantable pulmonary artery pressure monitor reduces heart failure hospitalisations in patients with moderately symptomatic (New York Heart Association [NYHA] functional class III) chronic heart failure and a hospitalisation in the past year, irrespective of ejection fraction. It is unclear if these benefits extend to patients with mild (NYHA functional class II) or severe (NYHA functional class IV) symptoms of heart failure or to patients with elevated natriuretic peptides without a recent heart failure hospitalisation. This trial was designed to evaluate whether haemodynamic-guided management using remote pulmonary artery pressure monitoring could reduce heart failure events and mortality in patients with heart failure across the spectrum of symptom severity (NYHA funational class II-IV), including those with elevated natriuretic peptides but without a recent heart failure hospitalisation.
METHODS


The randomised arm of the haemodynamic-GUIDEed management of Heart Failure (GUIDE-HF) trial was a multicentre, single-blind study at 118 centres in the USA and Canada. Following successful implantation of a pulmonary artery pressure monitor, patients with all ejection fractions, NYHA functional class II-IV chronic heart failure, and either a recent heart failure hospitalisation or elevated natriuretic peptides (based on a-priori thresholds) were randomly assigned (1:1) to either haemodynamic-guided heart failure management based on pulmonary artery pressure or a usual care control group. Patients were masked to their study group assignment. Investigators were aware of treatment assignment but did not have access to pulmonary artery pressure data for control patients. The primary endpoint was a composite of all-cause mortality and total heart failure events (heart failure hospitalisations and urgent heart failure hospital visits) at 12 months assessed in all randomly assigned patients. Safety was assessed in all patients. A pre-COVID-19 impact analysis for the primary and secondary outcomes was prespecified. This study is registered with ClinicalTrials.gov, NCT03387813.
FINDINGS


Between March 15, 2018, and Dec 20, 2019, 1022 patients were enrolled, with 1000 patients implanted successfully, and follow-up was completed on Jan 8, 2021. There were 253 primary endpoint events (0·563 per patient-year) among 497 patients in the haemodynamic-guided management group (treatment group) and 289 (0·640 per patient-year) in 503 patients in the control group (hazard ratio [HR] 0·88, 95% CI 0·74-1·05; p=0·16). A prespecified COVID-19 sensitivity analysis using a time-dependent variable to compare events before COVID-19 and during the pandemic suggested a treatment interaction (p interaction =0·11) due to a change in the primary endpoint event rate during the pandemic phase of the trial, warranting a pre-COVID-19 impact analysis. In the pre-COVID-19 impact analysis, there were 177 primary events (0·553 per patient-year) in the intervention group and 224 events (0·682 per patient-year) in the control group (HR 0·81, 95% CI 0·66-1·00; p=0·049). This difference in primary events almost disappeared during COVID-19, with a 21% decrease in the control group (0·536 per patient-year) relative to pre-COVID-19, virtually no change in the treatment group (0·597 per patient-year), and no difference between groups (HR 1·11, 95% CI 0·80-1·55; p=0·53). The cumulative incidence of heart failure events was not reduced by haemodynamic-guided management (0·85, 0·70-1·03; p=0·096) in the overall study analysis but was significantly decreased in the pre-COVID-19 impact analysis (0·76, 0·61-0·95; p=0·014). 1014 (99%) of 1022 patients had freedom from device or system-related complications.
INTERPRETATION


Haemodynamic-guided management of heart failure did not result in a lower composite endpoint rate of mortality and total heart failure events compared with the control group in the overall study analysis. However, a pre-COVID-19 impact analysis indicated a possible benefit of haemodynamic-guided management on the primary outcome in the pre-COVID-19 period, primarily driven by a lower heart failure hospitalisation rate compared with the control group.
FUNDING


Abbott.",2021,"The cumulative incidence of heart failure events was not reduced by haemodynamic-guided management (0·85, 0·70-1·03; p=0·096) in the overall study analysis but was significantly decreased in the pre-COVID-19 impact analysis (0·76, 0·61-0·95; p=0·014).","['Between March 15, 2018, and Dec 20, 2019, 1022 patients were enrolled, with 1000 patients implanted successfully, and follow-up was completed on Jan 8, 2021', '118 centres in the USA and Canada', 'patients with moderately symptomatic (New York Heart Association [NYHA] functional class III) chronic heart failure', 'patients with heart failure across the spectrum of symptom severity (NYHA funational class II-IV), including those with elevated natriuretic peptides but without a recent heart failure hospitalisation', '1014', 'patients with all ejection fractions, NYHA functional class II-IV chronic heart failure, and either a recent heart failure hospitalisation or elevated natriuretic peptides (based on a-priori thresholds', 'patients with mild (NYHA functional class II) or severe (NYHA functional class IV) symptoms of heart failure or to patients with elevated natriuretic peptides without a recent heart failure hospitalisation']","['Haemodynamic-guided management', 'implantable pulmonary artery pressure monitor', 'haemodynamic-guided management using remote pulmonary artery pressure monitoring', 'haemodynamic-guided heart failure management based on pulmonary artery pressure or a usual care control group']","['mortality and total heart failure events', 'freedom from device or system-related complications', 'composite of all-cause mortality and total heart failure events (heart failure hospitalisations and urgent heart failure hospital visits', 'cumulative incidence of heart failure events', 'Safety', 'heart failure hospitalisation rate']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0199629', 'cui_str': 'Pulmonary artery pressure monitoring'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1022.0,0.22255,"The cumulative incidence of heart failure events was not reduced by haemodynamic-guided management (0·85, 0·70-1·03; p=0·096) in the overall study analysis but was significantly decreased in the pre-COVID-19 impact analysis (0·76, 0·61-0·95; p=0·014).","[{'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt Heart and Vascular Institute, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: joann.lindenfeld@vumc.org.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina, RJH Department of Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Kunjan', 'Initials': 'K', 'LastName': 'Bhatt', 'Affiliation': 'Austin Heart, Austin, TX, USA.'}, {'ForeName': 'Anique', 'Initials': 'A', 'LastName': 'Ducharme', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Horstmanshof', 'Affiliation': 'Integris Baptist Medical Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Selim R', 'Initials': 'SR', 'LastName': 'Krim', 'Affiliation': 'John Ochsner Heart and Vascular Institute, Ochsner Medical Center, New Orleans, LA, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Maisel', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Catawba Valley Health System, Conover, NC, USA.'}, {'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Sears', 'Affiliation': 'East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sauer', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smart', 'Affiliation': 'Louisiana State University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Zughaib', 'Affiliation': 'Providence Hospital, Southfield, MI, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Castaneda', 'Affiliation': 'Austin Heart, Austin, TX, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Providence Hospital, Southfield, MI, USA.'}, {'ForeName': 'Nessa', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': 'Abbott, Abbott Park, IL, USA.'}, {'ForeName': 'Poornima', 'Initials': 'P', 'LastName': 'Sood', 'Affiliation': 'Abbott, Abbott Park, IL, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Ginn', 'Affiliation': 'Abbott, Abbott Park, IL, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Abbott, Abbott Park, IL, USA.'}, {'ForeName': 'Philip B', 'Initials': 'PB', 'LastName': 'Adamson', 'Affiliation': 'Abbott, Abbott Park, IL, USA.'}, {'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Costanzo', 'Affiliation': 'Advocate Heart Institute, Naperville, IL, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(21)01754-2']
1451,34465469,Anaesthetic depth and delirium after major surgery: a randomised clinical trial.,"BACKGROUND


Postoperative delirium is a serious complication of surgery associated with prolonged hospitalisation, long-term cognitive decline, and mortality. This study aimed to determine whether targeting bispectral index (BIS) readings of 50 (light anaesthesia) was associated with a lower incidence of POD than targeting BIS readings of 35 (deep anaesthesia).
METHODS


This multicentre randomised clinical trial of 655 at-risk patients undergoing major surgery from eight centres in three countries assessed delirium for 5 days postoperatively using the 3 min confusion assessment method (3D-CAM) or CAM-ICU, and cognitive screening using the Mini-Mental State Examination at baseline and discharge and the Abbreviated Mental Test score (AMTS) at 30 days and 1 yr. Patients were assigned to light or deep anaesthesia. The primary outcome was the presence of postoperative delirium on any of the first 5 postoperative days. Secondary outcomes included mortality at 1 yr, cognitive decline at discharge, cognitive impairment at 30 days and 1 yr, unplanned ICU admission, length of stay, and time in electroencephalographic burst suppression.
RESULTS


The incidence of postoperative delirium in the BIS 50 group was 19% and in the BIS 35 group was 28% (odds ratio 0.58 [95% confidence interval: 0.38-0.88]; P=0.010). At 1 yr, those in the BIS 50 group demonstrated significantly better cognitive function than those in the BIS 35 group (9% with AMTS ≤6 vs 20%; P<0.001).
CONCLUSIONS


Among patients undergoing major surgery, targeting light anaesthesia reduced the risk of postoperative delirium and cognitive impairment at 1 yr.
CLINICAL TRIAL REGISTRATION


ACTRN12612000632897.",2021,"At 1 yr, those in the BIS 50 group demonstrated significantly better cognitive function than those in the BIS 35 group (9% with AMTS ≤6 vs 20%; P<0.001).
","['after major surgery', '655 at-risk patients undergoing major surgery from eight centres in three countries assessed delirium for 5 days postoperatively using the 3 min confusion assessment method (3D-CAM) or CAM-ICU, and cognitive screening using the Mini-Mental State Examination at baseline and discharge and the Abbreviated Mental Test score (AMTS) at 30 days and 1 yr', 'patients undergoing major surgery']","['light or deep anaesthesia', 'light anaesthesia']","['bispectral index (BIS) readings', 'cognitive function', 'risk of postoperative delirium and cognitive impairment', 'incidence of postoperative delirium', 'Anaesthetic depth and delirium', 'presence of postoperative delirium', 'mortality at 1 yr, cognitive decline at discharge, cognitive impairment at 30 days and 1 yr, unplanned ICU admission, length of stay, and time in electroencephalographic burst suppression']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0450977', 'cui_str': 'Abbreviated mental test'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0475747', 'cui_str': 'Deep anesthesia'}, {'cui': 'C0475746', 'cui_str': 'Light anesthesia'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429306', 'cui_str': 'Burst suppression'}]",655.0,0.451452,"At 1 yr, those in the BIS 50 group demonstrated significantly better cognitive function than those in the BIS 35 group (9% with AMTS ≤6 vs 20%; P<0.001).
","[{'ForeName': 'Lisbeth A', 'Initials': 'LA', 'LastName': 'Evered', 'Affiliation': ""Department of Anesthesiology, Weill Cornell Medicine, New York, NY, USA; Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, VIC, Australia; Department of Critical Care Medicine, University of Melbourne, Melbourne, VIC, Australia. Electronic address: lae4004@med.cornell.edu.""}, {'ForeName': 'Matthew T V', 'Initials': 'MTV', 'LastName': 'Chan', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Ruquan', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital and Capital Medical University, Beijing, China.'}, {'ForeName': 'Mandy H M', 'Initials': 'MHM', 'LastName': 'Chu', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Benny P', 'Initials': 'BP', 'LastName': 'Cheng', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Scott', 'Affiliation': ""Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, VIC, Australia; Department of Critical Care Medicine, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Kane O', 'Initials': 'KO', 'LastName': 'Pryor', 'Affiliation': 'Department of Anesthesiology, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Veselis', 'Affiliation': 'Department of Anesthesiology, Weill Cornell Medicine, New York, NY, USA; Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sumner', 'Affiliation': 'Department of Anaesthesiology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Ade', 'Initials': 'A', 'LastName': 'Ayeni', 'Affiliation': 'Department of Anaesthesiology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Myles', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Department of Anaesthesiology, Auckland City Hospital, Auckland, New Zealand; Department of Anaesthesiology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': 'Department of Critical Care Medicine, University of Melbourne, Melbourne, VIC, Australia; Department of Anaesthesia and Pain Medicine, Royal Melbourne Hospital, Melbourne, VIC, Australia; Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Short', 'Affiliation': 'Department of Anaesthesiology, Auckland City Hospital, Auckland, New Zealand; Department of Anaesthesiology, University of Auckland, Auckland, New Zealand.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.07.021']
1452,34469793,"Bond assessment of enamel conditioned with Er, Cr: YSGG laser and methylene blue photosensitizer activated by photodynamic therapy to orthodontic metallic brackets.","AIM


To assess bond integrity and failure mode after enamel pretreated with conventional and contemporary conditioning methods were bonded to metallic brackets (MB).
MATERIAL AND METHODS


Forty maxillary central incisors were selected and disinfected. All specimens were mounted up to the cement-o-enamel junction and divided into four experimental groups randomly based on the enamel conditioning technique. Photodynamic therapy (PDT) was used to condition enamel in group 1, Total-etch and rinse (TER) was used to treat samples in group 2, Specimens in group 3 were conditioned with ECL, and samples in group 4 surface pretreated with SEP. Bonding of MB was performed on the surfaces of all the specimens with a Transbond XT. Specimens from all investigated groups were positioned on a universal testing machine maintaining buccal surfaces similar to the direction of the force. After bracket debonding bond failure was assessed using ARI. The bond integrity of all four groups was compared using analysis of variance (ANOVA). Post hoc Tukey test was used for pairwise comparison among different groups.
RESULTS


Group 2, TER+MB (15.38±0.14 MPa) displayed the highest bond value whereas the lowest values of SBS were exhibited by group 1, PDT+MB (10.11±0.17 MPa). The inter-group comparison revealed that specimens of group 2 and group 3, ECL+MB (14.61±0.55 MPa) demonstrated comparable bond strength (p>0.05).
CONCLUSION


Enamel conditioned with TER and ECL demonstrated comparable SBS. However, bond integrity after PDT and SEP (self-etch primer) surface treatment of enamel bonded with MB significantly lowered bond values.",2021,"However, bond integrity after PDT and SEP (self-etch primer) surface treatment of enamel bonded with MB significantly lowered bond values.","['orthodontic metallic brackets', 'Forty maxillary central incisors']","['ECL+MB', 'Photodynamic therapy (PDT', 'SEP', 'TER+MB', 'enamel conditioned with Er, Cr: YSGG laser and methylene blue photosensitizer', 'Total-etch and rinse (TER']",['bond integrity'],"[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205266', 'cui_str': 'Intact'}]",40.0,0.067417,"However, bond integrity after PDT and SEP (self-etch primer) surface treatment of enamel bonded with MB significantly lowered bond values.","[{'ForeName': 'Mohammad Shahul', 'Initials': 'MS', 'LastName': 'Hameed', 'Affiliation': 'Diagnostic Sciences and Oral Biology, College of Dentistry, King Khalid University, Abha, Saudi Arabia. Electronic address: mhmead@kku.edu.sa.'}, {'ForeName': 'Zuhair M', 'Initials': 'ZM', 'LastName': 'Alkahtani', 'Affiliation': 'Pediatric Dentistry and Orthodontic Sciences, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Ajmal', 'Affiliation': 'Diagnostic Sciences and Oral Biology, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Muhammad Abdullah', 'Initials': 'MA', 'LastName': 'Kamran', 'Affiliation': 'Pediatric Dentistry and Orthodontic Sciences, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Master Luqman', 'Initials': 'ML', 'LastName': 'Mannakandath', 'Affiliation': 'Diagnostic Sciences and Oral Biology, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alshahrani', 'Affiliation': 'Pediatric Dentistry and Orthodontic Sciences, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102513']
1453,34469763,Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy.,"BACKGROUND


Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence.
METHODS


ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362.
FINDINGS


Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86-1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91-1·32; p=0·21).
INTERPRETATION


Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable.
FUNDING


UK Medical Research Council and Health Technology Assessment Programme.",2021,"Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86-1·57; p=0·33).","['Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres', 'Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure', 'asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either', 'asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials']","['CAS', 'CAS or CEA', 'carotid artery stenting versus carotid endarterectomy', 'carotid artery stenting (CAS) or carotid endarterectomy (CEA']","['disabling stroke or death', 'fatal or disabling stroke', 'non-disabling procedural stroke', '5-year non-procedural stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C4047792', 'cui_str': 'Bilateral carotid artery stenosis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1285553', 'cui_str': 'Interprets'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0850458', 'cui_str': 'Carotid stent'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0439234', 'cui_str': 'year'}]",3625.0,0.147767,"Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86-1·57; p=0·33).","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Halliday', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK; Nuffield Department of Surgery, University of Oxford, Oxford, UK. Electronic address: alison.halliday@ndph.ox.ac.uk.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bulbulia', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK; Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Bonati', 'Affiliation': 'Department of Neurology, University Hospital, Basel, Switzerland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Chester', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cradduck-Bamford', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Peto', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hongchao', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK; Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)01910-3']
1454,34469767,"Initial treatment with a single pill containing quadruple combination of quarter doses of blood pressure medicines versus standard dose monotherapy in patients with hypertension (QUARTET): a phase 3, randomised, double-blind, active-controlled trial.","BACKGROUND


Treatment inertia is a recognised barrier to blood pressure control, and simpler, more effective treatment strategies are needed. We hypothesised that a hypertension management strategy starting with a single pill containing ultra-low-dose quadruple combination therapy would be more effective than a strategy of starting with monotherapy.
METHODS


QUARTET was a multicentre, double-blind, parallel-group, randomised, phase 3 trial among Australian adults (≥18 years) with hypertension, who were untreated or receiving monotherapy. Participants were randomly assigned to either treatment, that started with the quadpill (containing irbesartan at 37·5 mg, amlodipine at 1·25 mg, indapamide at 0·625 mg, and bisoprolol at 2·5 mg) or an indistinguishable monotherapy control (irbesartan 150 mg). If blood pressure was not at target, additional medications could be added in both groups, starting with amlodipine at 5 mg. Participants were randomly assigned using an online central randomisation service. There was a 1:1 allocation, stratified by site. Allocation was masked to all participants and study team members (including investigators and those assessing outcomes) except the manufacturer of the investigational product and one unmasked statistician. The primary outcome was difference in unattended office systolic blood pressure at 12 weeks. Secondary outcomes included blood pressure control (standard office blood pressure <140/90 mm Hg), safety, and tolerability. A subgroup continued randomly assigned allocation to 12 months to assess long-term effects. Analyses were per intention to treat. This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry, ACTRN12616001144404, and is now complete.
FINDINGS


From June 8, 2017, to Aug 31, 2020, 591 participants were recruited, with 743 assessed for eligibility, 152 ineligible or declined, 300 participants randomly assigned to intervention of initial quadpill treatment, and 291 to control of initial standard dose monotherapy treatment. The mean age of the 591 participants was 59 years (SD 12); 356 (60%) were male and 235 (40%) were female; 483 (82%) were White, 70 (12%) were Asian, and 38 (6%) reported as other ethnicity; and baseline mean unattended office blood pressure was 141 mm Hg (SD 13)/85 mm Hg (SD 10). By 12 weeks, 44 (15%) of 300 participants had additional blood pressure medications in the intervention group compared with 115 (40%) of 291 participants in the control group. Systolic blood pressure was lower by 6·9 mm Hg (95% CI 4·9-8·9; p<0·0001) and blood pressure control rates were higher in the intervention group (76%) versus control group (58%; relative risk [RR] 1·30, 95% CI 1·15-1·47; p<0·0001). There was no difference in adverse event-related treatment withdrawals at 12 weeks (intervention 4·0% vs control 2·4%; p=0·27). Among the 417 patients who continued, uptitration occurred more frequently among control participants than intervention participants (p<0·0001). However, at 52 weeks mean unattended systolic blood pressure remained lower by 7·7 mm Hg (95% CI 5·2-10·3) and blood pressure control rates higher in the intervention group (81%) versus control group (62%; RR 1·32, 95% CI 1·16-1·50). In all randomly assigned participants up to 12 weeks, there were seven (3%) serious adverse events in the intervention group and three (1%) serious adverse events in the control group.
INTERPRETATION


A strategy with early treatment of a fixed-dose quadruple quarter-dose combination achieved and maintained greater blood pressure lowering compared with the common strategy of starting monotherapy. This trial demonstrated the efficacy, tolerability, and simplicity of a quadpill-based strategy.
FUNDING


National Health and Medical Research Council, Australia.",2021,There was no difference in adverse event-related treatment withdrawals at 12 weeks (intervention 4·0% vs control 2·4%; p=0·27).,"['The mean age of the 591 participants was 59 years (SD 12); 356 (60%) were male and 235 (40%) were female; 483 (82%) were', 'patients with hypertension (QUARTET', '417 patients', 'From June 8, 2017, to Aug 31, 2020, 591 participants were recruited, with 743 assessed for eligibility, 152 ineligible or declined, 300 participants randomly assigned to', 'Australian adults (≥18 years) with hypertension, who were untreated or receiving']","['amlodipine', 'blood pressure medicines versus standard dose monotherapy', 'quadpill (containing irbesartan at 37·5 mg, amlodipine at 1·25 mg, indapamide at 0·625 mg, and bisoprolol at 2·5 mg) or an indistinguishable monotherapy control (irbesartan 150 mg', 'intervention of initial quadpill treatment', 'monotherapy']","['Systolic blood pressure', 'systolic blood pressure', 'blood pressure lowering', 'blood pressure control (standard office blood pressure <140/90 mm Hg), safety, and tolerability', 'unattended office systolic blood pressure', 'adverse event-related treatment withdrawals', 'blood pressure control rates', 'efficacy, tolerability, and simplicity', 'serious adverse events', 'additional blood pressure medications', 'office blood pressure', 'blood pressure']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0986849', 'cui_str': 'irbesartan 150 MG'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1701941', 'cui_str': 'Treatment withdrawal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1454365', 'cui_str': 'Simplicity (adhesive)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",591.0,0.479941,There was no difference in adverse event-related treatment withdrawals at 12 weeks (intervention 4·0% vs control 2·4%; p=0·27).,"[{'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia. Electronic address: clara.chow@sydney.edu.au.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Atkins', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Hillis', 'Affiliation': 'Royal Perth Hospital and Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health & Preventive Medicine Monash University, Melbourne, VIC, Australia; School of Population Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Markus P', 'Initials': 'MP', 'LastName': 'Schlaich', 'Affiliation': 'Dobney Hypertension Centre, Royal Perth Hospital Research Foundation, Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hay', 'Affiliation': 'Castle Hill Medical Centre, Sydney, NSW, Australia.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rogers', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia; Graduate School of Health, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Burke', 'Affiliation': 'School of Medicine, Western Sydney University, Sydney, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia; School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Usherwood', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Webster', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia; Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)01922-X']
1455,34477931,Different endurance exercises modulate NK cell cytotoxic and inhibiting receptors.,"PURPOSE


Induction of IDO depends on the activation of AhR forming the AhR/IDO axis. Activated AhR can transcribe various target genes including cytotoxic and inhibiting receptors of NK cells. We investigated whether AhR and IDO levels as well as activating (NKG2D) and inhibiting (KIR2DL1) NK cell receptors are influenced by acute exercise and different chronic endurance exercise programs.
METHODS


21 adult breast and prostate cancer patients of the TOP study (NCT02883699) were randomized to intervention programs of 12 weeks of (1) endurance standard training or (2) endurance polarized training after a cardiopulmonary exercise test (CPET). Serum was collected pre-CPET, immediately post-CPET, 1 h post-CPET and after 12 weeks post-intervention. Flow cytometry analysis was performed on autologous serum incubated NK-92 cells for: AhR, IDO, KIR2DL1 and NKG2D. Differences were investigated using analysis-of-variance for acute and analysis-of-covariance for chronic effects.
RESULTS


Acute exercise: IDO levels changed over time with a significant increase from post-CPET to 1 h post-CPET (p = 0.03). KIR2DL1 levels significantly decreased over time (p < 0.01). NKG2D levels remained constant (p = 0.31). Chronic exercise: for both IDO and NKG2D a significant group × time interaction, a significant time effect and a significant difference after 12 weeks of intervention were observed (IDO: all p < 0.01, NKG2D: all p > 0.05).
CONCLUSION


Both acute and chronic endurance training may regulate NK cell function via the AhR/IDO axis. This is clinically relevant, as exercise emerges to be a key player in immune regulation.",2021,KIR2DL1 levels significantly decreased over time (p < 0.01).,['21 adult breast and prostate cancer patients of the TOP study (NCT02883699'],"['chronic endurance training', 'endurance standard training or (2) endurance polarized training\xa0after a cardiopulmonary exercise test (CPET']","['activating (NKG2D) and inhibiting (KIR2DL1', 'NKG2D levels', 'KIR2DL1 levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C1430233', 'cui_str': 'KIR2DL1 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",21.0,0.0321925,KIR2DL1 levels significantly decreased over time (p < 0.01).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pal', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schlüter', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Steindorf', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wiskemann', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rosenberger', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Institute for Sport and Sport Science, Division of ""Performance and Health (Sports Medicine)"" , TU Dortmund University, August-Schmidt-Straße 4, 44227, Dortmund, Germany. philipp.zimmer@tu-dortmund.de.'}]",European journal of applied physiology,['10.1007/s00421-021-04735-z']
1456,34478577,Safety and efficacy of a platelet glycoprotein Ib inhibitor for patients with non-ST segment elevation myocardial infarction: A phase Ib/IIa study.,"STUDY OBJECTIVE


This study aimed to determine the safety and efficacy of a novel GP Ib receptor inhibitor in patients with non-ST segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI).
DESIGN AND SETTING


Multicenter, randomized, double-blind, placebo-controlled, dose-escalating, phase Ib-IIa clinical trial. Eligible patients were randomly assigned to the low-dose (n=20, 2 IU/60 kg), moderate-dose (n=20, 3 IU/60 kg), or high-dose anfibatide group (n=20, 5 IU/60 kg), or the placebo group (n=30). Anfibatide was administered for up to 48 hours along with standard aspirin and clopidogrel therapy.
PATIENTS


Ninety patients with NSTEMI who underwent PCI at six academic hospitals in China.
MEASUREMENTS AND MAIN RESULTS


All three doses of anfibatide showed dose-dependent antiplatelet activity as measured by ex vivo platelet aggregation at 5 minutes, 24 hours, and 48 hours during infusion, and 4 hours post-infusion compared with placebo. Higher inhibition of platelet aggregation occurred in all anfibatide groups compared with the placebo group. The post-procedural TIMI grade flow, myocardial blush grade, and corrected TIMI frame count were not significantly different among the four groups. Thirty-day mortality, non-fatal myocardial infarction, and major bleeding were rare and comparable between patients who received anfibatide and placebo. There was no significant difference in the platelet count among the groups during follow-up.
CONCLUSIONS


This study shows that intravenous administration of the platelet receptor GP Ib antagonist anfibatide is feasible and safe to inhibit platelet aggregation without increasing the risk of bleeding and thrombocytopenia in patients with NSTEMI undergoing PCI.",2021,"All three doses of anfibatide showed dose-dependent antiplatelet activity as measured by ex vivo platelet aggregation at 5 minutes, 24 hours, and 48 hours during infusion, and 4 hours post-infusion compared with placebo.","['patients with non-ST segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI', 'Patients with Non-ST Segment Elevation Myocardial Infarction', 'Ninety Chinese patients with NSTEMI who underwent PCI at six Chinese hospitals']","['aspirin and clopidogrel therapy', 'placebo', 'GP Ib receptor inhibitor, anfibatide', 'Platelet Glycoprotein Ib Inhibitor']","['platelet count', 'safety and efficacy', 'Thirty-day mortality, non-fatal myocardial infarction, and major bleeding', 'post-procedural TIMI grade flow, myocardial blush grade, and corrected TIMI frame count', 'Safety and Efficacy', 'platelet aggregation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032190', 'cui_str': 'Glycoprotein Ib'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0086816', 'cui_str': 'Platelet Glycoproteins'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}]",90.0,0.128497,"All three doses of anfibatide showed dose-dependent antiplatelet activity as measured by ex vivo platelet aggregation at 5 minutes, 24 hours, and 48 hours during infusion, and 4 hours post-infusion compared with placebo.","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Dingcheng', 'Initials': 'D', 'LastName': 'Xiang', 'Affiliation': 'Department of Cardiology, General Hospital of Southern Theater Command, Guangzhou, China.'}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Hesong', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Department of Cardiology, Tongji Medical College, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiangrong', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'Zhaoke Pharmaceutical (Hefei) Co., Ltd., Hefei, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Zhaoke Pharmaceutical (Hefei) Co., Ltd., Hefei, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}]",Pharmacotherapy,['10.1002/phar.2620']
1457,34479045,Longitudinal effect of nutritional intervention on body weight: A randomized controlled trial.,"OBJECTIVES


This study evaluates, in the medium and long term (12, 36, and 48 mo), the effect of an intervention to promote consumption of fruit and vegetables on the body weight of Brazilian primary health care users.
METHODS


A follow-up with participants (n = 3414) in a controlled randomized trial was performed in a primary health care service. Those in the control group performed the service's usual intervention (guided physical exercise 3 times/wk), and those in the intervention group additionally participated for 7 mo in collective activities to promote consumption of fruit and vegetables. Sociodemographic, health, and body weight data were collected by face-to-face interview at baseline and after 12 mo. At 36 and 48 mo, weight was obtained by telephone interview and was validated. Adherence to the intervention was assessed by the presence of the actions. Weight change (Δ) was measured by subtracting the weight at each follow-up time from the baseline measurement.
RESULTS


Participants in both groups had a minor weight loss of about 0.1 kg over 12, 36, and 48 mo. The addition of an intervention for consumption of fruit and vegetables did not enhance this effect. Higher weight loss was observed in individuals with obesity classes II and III with low adherence in the intervention and after 36 mo (Δ = -27.1 kg; P = 0.024).
CONCLUSIONS


Participating in the primary health care service contributed to a small reduction in weight, and the intervention for consumption of fruit and vegetables did not enhance this effect. However, greater weight loss was observed in participants with obesity and those who adhered to the intervention.",2021,"Higher weight loss was observed in individuals with obesity classes II and III with low adherence in the intervention and after 36 mo (Δ = -27.1 kg; P = 0.024).
",['Brazilian primary health care users'],"['nutritional intervention', ""service's usual intervention (guided physical exercise 3 times/wk), and those in the intervention group additionally participated for 7 mo in collective activities to promote consumption of fruit and vegetables""]","['Sociodemographic, health, and body weight data', 'weight loss', 'Higher weight loss', 'body weight', 'minor weight loss']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",,0.0426848,"Higher weight loss was observed in individuals with obesity classes II and III with low adherence in the intervention and after 36 mo (Δ = -27.1 kg; P = 0.024).
","[{'ForeName': 'Aline Cristine Souza', 'Initials': 'ACS', 'LastName': 'Lopes', 'Affiliation': 'Department of Nutrition, Universidade Federal de Minas Gerais, Research Group in Nutrition Interventions (GIN-UFMG), Santa Efigênia, Brazil. Electronic address: alinelopesenf@gmail.com.'}, {'ForeName': 'Mariana Souza', 'Initials': 'MS', 'LastName': 'Lopes', 'Affiliation': 'Department of Nutrition, Universidade Federal de Minas Gerais, Research Group in Nutrition Interventions (GIN-UFMG), Santa Efigênia, Brazil.'}, {'ForeName': 'Camila Kummel', 'Initials': 'CK', 'LastName': 'Duarte', 'Affiliation': 'Department of Nutrition, Universidade Federal de Minas Gerais, Research Group in Nutrition Interventions (GIN-UFMG), Santa Efigênia, Brazil.'}, {'ForeName': 'Patrícia Pinheiro', 'Initials': 'PP', 'LastName': 'de Freitas', 'Affiliation': 'Department of Preventive and Social Medicine, Universidade Federal de Minas Gerais, Research Group in Nutrition Interventions (GIN-UFMG), Santa Efigênia, Brazil.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2021.111436']
1458,34463947,Use of a Digital Chronic Obstructive Pulmonary Disease Respiratory Tracker in a Primary Care Setting: A Feasibility Study.,"INTRODUCTION


Telemonitoring is a promising self-management strategy to improve health care outcomes. This study evaluated real-world adoption of the chronic obstructive pulmonary disease (COPD) Co-Pilot daily symptom monitoring tool by patients and primary care providers (PCPs).
METHODS


An open-label, 6-month, single-arm, multicenter, noninterventional feasibility study enrolled 97 patients aged ≥ 40 years with symptomatic or poorly controlled COPD and ≥ 10 pack-year smoking history. Patients received smartphones and training to use the COPD Co-Pilot application. During the study, patients tracked symptoms daily; an increase in symptom score of ≥ 1.0 point from baseline (symptom alert) prompted patients to contact their PCP via toll-free number. The primary endpoint was time to clinical recommendation (TTCR) from a symptom alert; adherence to completing daily symptom reports through the COPD Co-Pilot application and patient satisfaction were also measured.
RESULTS


Overall, 87 of 96 patients (90.6%) received 2142 symptom alerts; 42 alerts (equivalent to 2% of all symptom alerts) resulted in 23 patients contacting their PCP. Median TTCR was 7.1 h (interquartile range [IQR]: 4.0-29.9). Among 15 patients using the toll-free number, median TTCR was 2.1 h (IQR 0.0-7.2) versus 19.6 h (IQR 4.5-45.2) for eight patients using other contact methods. Average COPD Co-Pilot adherence overall was 75.2% (95% CI 74.6-75.9). Patients responded favorably regarding the application's ease of use, functionality, and information provided.
CONCLUSIONS


The COPD Co-Pilot tool was associated with relatively high levels of adherence, suggesting patients' willingness to monitor symptoms daily. Although a limited number of patients initiated PCP contact, patients who used the study-provided toll-free number had substantially shorter median TTCR, suggesting that this tool could help empower patients to better manage their COPD.",2021,Average COPD Co-Pilot adherence overall was 75.2% (95% CI 74.6-75.9).,"['97 patients aged\u2009≥', '40\xa0years with symptomatic or poorly controlled COPD and\u2009≥\u200910 pack-year smoking history', 'patients and primary care providers (PCPs']","['Digital Chronic Obstructive Pulmonary Disease Respiratory Tracker', 'smartphones and training to use the COPD Co-Pilot application']","['symptom score', 'Average COPD Co-Pilot adherence overall', 'median TTCR', 'Median TTCR', 'time to clinical recommendation (TTCR) from a symptom alert; adherence to completing daily symptom reports through the COPD Co-Pilot application and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",97.0,0.10413,Average COPD Co-Pilot adherence overall was 75.2% (95% CI 74.6-75.9).,"[{'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Temple University Hospital, Philadelphia, PA, USA. gerard.criner@tuhs.temple.edu.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Cole', 'Affiliation': 'IQVIA, Rockville, MD, USA.'}, {'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Hahn', 'Affiliation': 'IQVIA, Cambridge, MA, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kastango', 'Affiliation': 'IQVIA, Cambridge, MA, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Eudicone', 'Affiliation': 'AstraZeneca, Wilmington, DE, USA.'}, {'ForeName': 'Ileen', 'Initials': 'I', 'LastName': 'Gilbert', 'Affiliation': 'AstraZeneca, Wilmington, DE, USA.'}]",Pulmonary therapy,['10.1007/s41030-021-00168-3']
1459,34463869,Phase III study of adjuvant gemcitabine compared with adjuvant uracil-tegafur in patients with completely resected pathological stage IB-IIIA non-small cell lung cancer (WJTOG0101).,"BACKGROUND


Adjuvant oral uracil-tegafur (UFT) has led to significantly longer postoperative survival among patients with non-small-cell lung cancer (NSCLC). Gemcitabine (GEM) monotherapy is also reportedly effective for NSCLC and has minor adverse events (AEs). This study compared the efficacy of GEM- versus UFT-based adjuvant regimens in patients with completely resected pathological stage (p-stage) IB-IIIA NSCLC.
PATIENTS AND METHODS


Patients with completely resected p-stage IB-IIIA NSCLC were randomly assigned to GEM or UFT. The primary endpoint was overall survival (OS); secondary endpoints were disease-free survival (DFS), and AEs.
RESULTS


We assigned 305 patients to the GEM group and 303 to the UFT group. Baseline factors were balanced between the arms. Of the 608 patients, 293 (48.1%) had p-stage IB disease, 195 (32.0%) had p-stage II disease and 121 (19.9%) had p-stage IIIA disease. AEs were generally mild in both groups, and only one death occurred, in the GEM group. After a median follow-up of 6.8 years, the two groups did not significantly differ in survival: 5 year OS rates were GEM: 70.0%, UFT: 68.8% (hazard ratio 0.948; 95% confidence interval 0.73-1.23; P = 0.69).
CONCLUSION


Although GEM-based adjuvant therapy for patients with completely resected stage IB-IIIA NSCLC was associated with acceptable toxicity, it did not provide longer OS than did UFT.",2021,"After a median follow-up of 6.8 years, the two groups did not significantly differ in survival: 5 year OS rates were GEM: 70.0%, UFT: 68.8% (hazard ratio 0.948; 95% confidence interval 0.73-1.23; P = 0.69).
","['patients with non-small-cell lung cancer (NSCLC', '305 patients to the GEM group and 303 to the UFT group', 'patients with completely resected pathological stage (p-stage', 'patients with completely resected pathological stage IB-IIIA non-small cell lung cancer (WJTOG0101', 'patients with completely resected stage IB-IIIA NSCLC', 'Patients with completely resected p-stage IB-IIIA NSCLC']","['uracil-tegafur (UFT', 'adjuvant gemcitabine', 'GEM or UFT', 'GEM-based adjuvant therapy', 'Gemcitabine (GEM) monotherapy', 'adjuvant uracil-tegafur', 'GEM- versus UFT-based adjuvant regimens']","['death', 'postoperative survival', 'overall survival (OS); secondary endpoints were disease-free survival (DFS), and AEs', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1446539', 'cui_str': 'Tegafur- and uracil-containing product'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}]","[{'cui': 'C0041917', 'cui_str': 'Uracil'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C1446539', 'cui_str': 'Tegafur- and uracil-containing product'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",305.0,0.652267,"After a median follow-up of 6.8 years, the two groups did not significantly differ in survival: 5 year OS rates were GEM: 70.0%, UFT: 68.8% (hazard ratio 0.948; 95% confidence interval 0.73-1.23; P = 0.69).
","[{'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka City, Fukuoka, Japan.'}, {'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Thoracic Surgery, Osaka City General Hospital, Osaka City, Osaka, Japan. htada@asahi.email.ne.jp.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Mitsudomi', 'Affiliation': 'Department of Thoracic Surgery, Aichi Cancer Center, Nagoya City, Aichi, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka City, Fukuoka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Yokoi', 'Affiliation': 'Department of Thoracic Surgery, Nagoya University School of Medicine, Nagoya City, Aichi, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Katakami', 'Affiliation': 'Division of Pulmonary Medicine, Kobe City Medical Center General Hospital, Kobe City, Hyogo, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kinki University School of Medicine, Osakasayama City, Osaka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Oda', 'Affiliation': 'Department of Thoracic Surgery, Kanazawa University School of Medicine, Kanazawa City, Ishikawa, Japan.'}, {'ForeName': 'Mitsunori', 'Initials': 'M', 'LastName': 'Ohta', 'Affiliation': 'Department of Thoracic Surgery, Osaka Habikino Medical Center, Habikino City, Osaka, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Sawa', 'Affiliation': 'Department of Pulmonary Medicine, Gifu Municipal Hospital, Gifu City, Gifu, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Yamashita', 'Affiliation': 'Department of Thoracic Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama City, Ehime, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Iked', 'Affiliation': 'Department of Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'Department of Pulmonary Medicine, National Hospital Organization Nagoya Hospital, Nagoya City, Aichi, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Higashiyama', 'Affiliation': 'Department of General Thoracic Surgery, Osaka International Cancer Institute, Osaka City, Osaka, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nomori', 'Affiliation': 'Department of Thoracic Surgery, School of Medicine, Kumamoto University, Kumamoto City, Kumamoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Semba', 'Affiliation': 'Division of Respiratory Disease, Kumamoto Regional Medical Center, Kumamoto City, Kumamoto, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Negoro', 'Affiliation': 'Department of Medical Oncology, Hyogo Cancer Center, Akashi City, Hyogo, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Chiba', 'Affiliation': 'Division of Biostatistics, Clinical Research Center, Kinki University School of Medicine, Osakasayama CIty, Osaka, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Biostatistics, Yamaguchi University School of Medicine, Yamaguchi City, Yamaguchi, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Fukuoka', 'Affiliation': 'Department of Medical Oncology, Kinki University School of Medicine, Osakasayama City, Osaka, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakanishi', 'Affiliation': 'Research Institute for Diseases of the Chest, Kyushu University, Fukuoka City, Fukuoka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of clinical oncology,['10.1007/s10147-021-02012-9']
1460,34463420,Glycaemic efficacy of an expanded dose range of dulaglutide according to baseline glycated haemoglobin (HbA1c) subgroup: Post hoc analysis of AWARD-11.,"The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin. This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%). Mean reductions in HbA1c were observed across all baseline HbA1c subgroups at 36 weeks (range of HbA1c change: 1.5 mg: -1.0% to -2.2%; 3.0 mg: -1.2% to -2.5%; and 4.5 mg: -1.2% to -3.2%). More patients randomized to 3.0 mg or 4.5 mg (vs. 1.5 mg) achieved HbA1c <7% at 36 weeks regardless of baseline HbA1c; the difference in proportions was greater at higher baseline HbA1c (P-interaction = 0.096). Similar patterns in glycaemic improvement and proportions achieving HbA1c <7% were observed at 52 weeks. Hypoglycaemia and gastrointestinal adverse events were similar among the HbA1c subgroups. Glycaemic control was improved with dulaglutide dose escalation from 1.5 mg to 3.0 mg or 4.5 mg across baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).",2021,More patients randomized to 3.0 or 4.5 mg (vs. 1.5 mg) achieved HbA1c <7% at 36 weeks regardless of baseline HbA1c; the difference in proportions was greater at higher baseline HbA1c (p-interaction = 0.096).,['patients with type 2 diabetes inadequately controlled with'],['metformin'],"['Hypoglycemia and gastrointestinal adverse events', 'Glycemic control', 'safety and efficacy', 'Glycemic Efficacy', 'glycemic improvement and proportions achieving HbA1c', 'Mean reductions in HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.190142,More patients randomized to 3.0 or 4.5 mg (vs. 1.5 mg) achieved HbA1c <7% at 36 weeks regardless of baseline HbA1c; the difference in proportions was greater at higher baseline HbA1c (p-interaction = 0.096).,"[{'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Bonora', 'Affiliation': 'University and University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cox', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'M Angelyn', 'Initials': 'MA', 'LastName': 'Bethel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Anita Y M', 'Initials': 'AYM', 'LastName': 'Kwan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sohini', 'Initials': 'S', 'LastName': 'Raha', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Raleigh E', 'Initials': 'RE', 'LastName': 'Malik', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14533']
1461,34463415,Potential contribution of haemoconcentration to changes in lipid variables with empagliflozin in patients with type 2 diabetes: A post hoc analysis of pooled data from four phase 3 randomized clinical trials.,"AIM


To examine the association between changes in lipids and markers of haemoconcentration (haematocrit and serum albumin) with empagliflozin, a sodium-glucose co-transporter-2 inhibitor, in patients with type 2 diabetes (T2D) using pooled data from four phase 3 randomized trials.
MATERIALS AND METHODS


Patients with T2D received placebo (n = 825), empagliflozin 10 mg (n = 830) or 25 mg (n = 822) for 24 weeks. In post hoc mediation analyses, we assessed total changes in LDL-cholesterol, HDL-cholesterol, triglycerides, apolipoprotein (Apo) B, and Apo A-I, and changes in these variables associated with, and independent of, changes in haematocrit and serum albumin at week 24 using ANCOVA models.
RESULTS


Empagliflozin versus placebo increased serum LDL-cholesterol, HDL-cholesterol, and Apo A-I, decreased triglycerides (empagliflozin 10 mg only), and (non-significantly) increased Apo B. Empagliflozin modestly increased haematocrit and serum albumin. In mediation analyses, haematocrit changes (increases) with empagliflozin were associated with significant changes (increases) in all lipid variables, including Apo B. Except for triglycerides (non-significant), similar lipid variable associations were observed with serum albumin changes. Haematocrit- and serum albumin-independent changes in lipids with empagliflozin were significant for HDL-cholesterol (increases), mostly significant for triglycerides (decreases), and less so for other lipid fractions.
CONCLUSION


Haematocrit and serum albumin increases were associated with increases in lipid fractions with empagliflozin. Empagliflozin-associated changes in serum lipids, particularly LDL-cholesterol increases, may be partly attributable to haemoconcentration resulting from increased urinary volume and subsequent volume contraction.",2021,"Haematocrit- and serum albumin-independent changes in lipids with empagliflozin were significant for HDL-cholesterol (increases), mostly significant for triglycerides (decreases), and less so for other lipid fractions.
","['type 2 diabetes mellitus (T2DM) patients', 'patients with type 2 diabetes mellitus', 'T2DM patients received']","['placebo', 'Empagliflozin', 'selective sodium-glucose cotransporter 2 inhibitor empagliflozin', 'empagliflozin']","['serum LDL-cholesterol, HDL-cholesterol, and Apo A-I, decreased triglycerides', 'urinary glucose, sodium excretion, and urinary volume, and reduces plasma glucose', 'total changes in LDL-cholesterol, HDL-cholesterol, triglycerides, apolipoprotein (Apo) B, and Apo A-I, and changes', 'HDL-cholesterol', 'lipid fractions', 'serum lipids, particularly LDL-cholesterol increases', 'haematocrit and serum albumin', 'haematocrit changes', 'Haematocrit- and serum albumin', 'Apo B']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0549399', 'cui_str': 'Low density lipoprotein increased'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}]",,0.0357879,"Haematocrit- and serum albumin-independent changes in lipids with empagliflozin were significant for HDL-cholesterol (increases), mostly significant for triglycerides (decreases), and less so for other lipid fractions.
","[{'ForeName': 'Søren S', 'Initials': 'SS', 'LastName': 'Lund', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Salsali', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut, USA.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Neubacher', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Henry N', 'Initials': 'HN', 'LastName': 'Ginsberg', 'Affiliation': 'Vagelos College of Physicians and Surgeons of Columbia University, New York, New York, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14534']
1462,34463409,Effects of empagliflozin on insulin initiation or intensification in patients with type 2 diabetes and cardiovascular disease: Findings from the EMPA-REG OUTCOME trial.,"AIM


To evaluate the effects of empagliflozin versus placebo on subsequent insulin initiation or dosing changes in a large cardiovascular outcomes trial.
MATERIALS AND METHODS


In EMPA-REG OUTCOME, 7020 patients with type 2 diabetes and cardiovascular disease received empagliflozin 10 mg, 25 mg, or placebo. Median follow-up was 3.1 years. After 12 weeks of treatment, changes in background antihyperglycaemic therapy were permitted. Among insulin-naïve patients, we assessed the effects of pooled empagliflozin arms versus placebo on time to initiation of insulin. Among insulin-treated patients, we assessed effects on time to an increase or decrease in insulin dose of more than 20%.
RESULTS


In 3633 (52%) participants not treated with insulin at baseline, empagliflozin reduced new use of insulin versus placebo by 60% (7.1% vs. 16.4%; adjusted HR 0.40 [95% CI 0.32-0.49]; P < .0001). In 3387 (48%) patients using insulin at baseline, empagliflozin reduced the need for a greater than 20% insulin dose increase by 58% (14.4% vs. 29.3%; adjusted HR 0.42 [95% CI 0.36-0.49]; P < .0001) and increased the proportion achieving sustained greater than 20% insulin dose reductions without subsequent increases in HbA1c compared with placebo (9.2% vs. 4.9%; adjusted HR 1.87 [95% CI: 1.39-2.51]; P < .0001). Sensitivity analyses confirmed consistent findings when insulin dose changes of more than 10% or more than 30% were considered.
CONCLUSIONS


In patients with type 2 diabetes and cardiovascular disease, empagliflozin markedly and durably delays insulin initiation and substantial increases in insulin dose, while facilitating sustained reductions in insulin requirements over time.",2021,"In 3,387 (48%) patients using insulin at baseline, empagliflozin reduced need for a >20% insulin dose increase by 58% (14.4% vs. 29.3%; adjusted HR 0.42","['Patients with Type 2 Diabetes and Cardiovascular Disease', '7,020 patients with type 2 diabetes and cardiovascular disease received']","['insulin vs. placebo', 'placebo', 'Empagliflozin', 'empagliflozin']","['time to initiation of insulin', 'Insulin Initiation or Intensification', 'proportion achieving sustained >20% insulin dose reductions without subsequent increases in HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",7020.0,0.251523,"In 3,387 (48%) patients using insulin at baseline, empagliflozin reduced need for a >20% insulin dose increase by 58% (14.4% vs. 29.3%; adjusted HR 0.42","[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fitchett', 'Affiliation': ""Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Medical Department, Boehringer Ingelheim KS, Asker, Norway.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mattheus', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Internal Medicine I, Nephrology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, Mississippi, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14535']
1463,34472416,Computerized Working Memory Training for Children With Neurofibromatosis Type 1 (NF1): A Pilot Study.,"INTRODUCTION


The present study aimed to evaluate the feasibility and efficacy of  CogmedRM,  a computerized, home-based working memory (WM) training program, in children with NF1.
METHOD


A pre-post design was used to evaluate changes in performance-based measures of attention and WM, and parent-completed ratings of executive functioning. Children meeting eligibility criteria completed  CogmedRM  over 9 weeks. Primary outcomes included compliance statistics and change in attention and WM scores.
RESULTS


Thirty-one children (52% male; M age = 10.97 ± 2.51), aged 8-15, were screened for participation; 27 children (87%) evidenced WM difficulties and participated in  CogmedRM  training. On average, participants completed 19.7 out of 25 prescribed sessions, with an adherence rate of 69%. Participants demonstrated improvements in short-term memory, attention, and executive functioning (all  Ps  < .05).
CONCLUSION


Results suggest that computerized, home-based WM training programs may be both feasible and efficacious for children with NF1 and cognitive deficits.",2021,"Participants demonstrated improvements in short-term memory, attention, and executive functioning (all  Ps  < .05).
","['Children With Neurofibromatosis Type 1', 'Thirty-one children (52% male; M age = 10.97 ± 2.51), aged 8-15, were screened for participation; 27 children (87%) evidenced WM difficulties and participated in  CogmedRM  training', 'children with NF1 and cognitive deficits', 'children with NF1']","['CogmedRM,  a computerized, home-based working memory (WM) training program', 'NF1', 'Computerized Working Memory Training']","['short-term memory, attention, and executive functioning', 'performance-based measures of attention and WM, and parent-completed ratings of executive functioning', 'compliance statistics and change in attention and WM scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",31.0,0.0213113,"Participants demonstrated improvements in short-term memory, attention, and executive functioning (all  Ps  < .05).
","[{'ForeName': 'Kristina K', 'Initials': 'KK', 'LastName': 'Hardy', 'Affiliation': ""Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Berger', 'Affiliation': ""Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Griffin', 'Affiliation': ""Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Walsh', 'Affiliation': ""Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Sharkey', 'Affiliation': ""Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Weisman', 'Affiliation': ""Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gioia', 'Affiliation': ""Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Packer', 'Affiliation': ""Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Acosta', 'Affiliation': 'National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}]",Journal of child neurology,['10.1177/08830738211038083']
1464,34476464,Problem-solving therapy-induced amygdala engagement mediates lifestyle behavior change in obesity with comorbid depression: a randomized proof-of-mechanism trial.,"BACKGROUND


Depression hinders obesity treatment; elucidating mechanisms may enable treatment enhancements.
OBJECTIVES


The aim was to investigate whether changes in neural targets in the negative affect circuit following psychotherapy mediate subsequent changes in weight and behaviors.
METHODS


Adults (n = 108) with obesity and depression were randomly assigned to usual care or an intervention that delivered problem-solving therapy (PST) for depression over 2 mo. fMRI for brain imaging was performed at baseline and 2 mo. BMI, physical activity, and diet were measured at baseline and 12 mo. Mediation analysis assessed between-group differences in neural target changes using t test and correlations between neural target changes and outcome changes (simple and interaction effect) using ordinary least-squares regression.
RESULTS


Compared with usual care, PST led to reductions in left amygdala activation (-0.75; 95% CI: -1.49, -0.01) and global scores of the negative affect circuit (-0.43; -0.81, -0.06), engaged by threat stimuli. Increases in amygdala activation and global circuit scores at 2 mo correlated with decreases in physical activity outcomes at 12 mo in the usual-care group; these relations were altered by PST. In relation to change in leisure-time physical activity, standardized β-coefficients were -0.67 in usual care and -0.01 in the intervention (between-group difference: 0.66; 0.02, 1.30) for change in left amygdala activation and -2.02 in usual care and -0.11 in the intervention (difference: 1.92; 0.64, 3.20) for change in global circuit scores. In relation to change in total energy expenditure, standardized β-coefficients were -0.65 in usual care and 0.08 in the intervention (difference: 0.73; 0.29, 1.16) for change in left amygdala activation and -1.65 in usual care and 0.08 in the intervention (difference: 1.74; 0.85, 2.63) for change in global circuit scores. Results were null for BMI and diet.
CONCLUSIONS


Short-term changes in the negative affect circuit engaged by threat stimuli following PST for depression mediated longer-term changes in physical activity. This trial was registered at www.clinicaltrials.gov as NCT02246413 (https://clinicaltrials.gov/ct2/show/NCT02246413).",2021,"Compared with usual care, PST led to reductions in left amygdala activation (-0.75; 95% CI: -1.49, -0.01) and global scores of the negative affect circuit (-0.43; -0.81, -0.06), engaged by threat stimuli.","['obesity with comorbid depression', 'Adults (n\xa0=\xa0108) with obesity and depression']","['Problem-solving therapy-induced amygdala engagement', 'usual care or an intervention that delivered problem-solving therapy (PST']","['BMI, physical activity, and diet', 'weight and behaviors', 'global scores of the negative affect circuit', 'leisure-time physical activity, standardized β-coefficients', 'left amygdala activation', 'total energy expenditure, standardized β-coefficients', 'amygdala activation and global circuit scores', 'global circuit scores', 'physical activity outcomes']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",108.0,0.0358485,"Compared with usual care, PST led to reductions in left amygdala activation (-0.75; 95% CI: -1.49, -0.01) and global scores of the negative affect circuit (-0.43; -0.81, -0.06), engaged by threat stimuli.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Wesley K', 'Initials': 'WK', 'LastName': 'Lefferts', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wielgosz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Simmons', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Departments of Biobehavioral Health and Medicine, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stetz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Center for Communication Science, RTI International, Seattle, WA, USA.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Harborview Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Olusola A', 'Initials': 'OA', 'LastName': 'Ajilore', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab280']
1465,34479835,Use of a combination of N-acetylcysteine and clonazepam to treat burning mouth syndrome.,"OBJECTIVE


This study was intended to evaluate the clinical efficacy of a combination of N-acetylcysteine (NAC) and clonazepam for treatment of burning mouth syndrome (BMS).
STUDY DESIGN


A total of 160 patients with BMS were divided into 3 groups: group 1 received NAC (400 mg/d), group 2 received clonazepam (0.5 mg/d), and group 3 received both NAC and clonazepam. We evaluated symptom relief after 8 weeks of treatment using a visual analog scale (VAS). To assess oral health-related quality of life, we used the validated Korean version of an oral health impact profile (OHIP-14K).
RESULTS


The overall response rates of the 3 groups were 60.3%, 51.3%, and 80.0%, respectively. The mean VAS and OHIP-14K scores significantly decreased in all groups after the 8-week treatments. The VAS score changes were -12.2 ± 19.5, -10.0 ± 14.1, and -21.0 ± 24.6, respectively (P = .001), in the 3 groups and the OHIP-14K changes were -2.3 ± 9.2, -4.4 ± 6.9, and -8.7 ± 10.3, respectively (P = .020). Group 3 showed significantly larger differences in VAS and OHIP-14K scores than group 2, before and after treatment.
CONCLUSIONS


In the treatment of BMS, the NAC/clonazepam combination therapy was more effective than either monotherapy.",2021,"Group 3 showed significantly larger differences in VAS and OHIP-14K scores than group 2, before and after treatment.
","['160 patients with BMS', 'burning mouth syndrome (BMS']","['combination of N-acetylcysteine (NAC) and clonazepam', 'NAC', 'combination of N-acetylcysteine and clonazepam', 'NAC and clonazepam', 'clonazepam']","['visual analog scale (VAS', 'mean VAS and OHIP-14K scores', 'VAS score changes', 'VAS and OHIP-14K scores', 'overall response rates', 'symptom relief']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006430', 'cui_str': 'Burning mouth syndrome'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0009011', 'cui_str': 'Clonazepam'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",160.0,0.022023,"Group 3 showed significantly larger differences in VAS and OHIP-14K scores than group 2, before and after treatment.
","[{'ForeName': 'Sungjun', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': ""Clinical Assistant Professor, Department of Otolaryngology-Head and Neck Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Ji-Hyung', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': ""Doctor, Department of Otolaryngology-Head and Neck Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jooin', 'Initials': 'J', 'LastName': 'Bang', 'Affiliation': ""Doctor, Department of Otolaryngology-Head and Neck Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jung-Hae', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': ""Assistant Professor, Department of Otolaryngology-Head and Neck Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: junghae.cho@gmail.com.""}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2021.07.016']
1466,34478869,Changing Talk Online: Protocol for a cluster pragmatic trial testing communication education to reduce behavioral and psychological symptoms of dementia in nursing home care.,"Nursing home (NH) care of persons living with dementia is often made challenging by behavioral and psychological symptoms of dementia (BPSD) such as aggression, vocal outbursts, wandering, and withdrawal that occur due to cognitive and communication changes. Staff frequently communicate to NH residents using ""elderspeak"" which is patronizing speech similar to baby talk. Residents respond to elderspeak with increased BPSD that prompts use of psychotropic medication to control symptoms. The Changing Talk (CHAT) training educates staff about effective, person-centered communication strategies and reduces elderspeak by staff and subsequent BPSD among residents. This study will test effects of an adapted online version (CHATO) increasing access and dissemination of education to busy staff across diverse care settings. Nursing homes (N = 128) will be stratified and then randomized to CHATO education (n = 64) or to the control group (n = 64). Data on behavioral symptoms (primary outcomes) and psychotropic medication use (secondary outcomes) will be extracted from the Center for Medicare and Medicaid Services Minimum Data Set before and after education and will be compared between the groups using generalized linear mixed modeling. It is hypothesized that after completing the CHATO education residents will have reduced behavioral symptoms and psychotropic medication use compared to residents in control NHs. Additionally, factors related to NH participation and cost of the intervention will be determined. The overall goal of this study is to prepare for large scale dissemination and implementation of the evidence-based nonpharmacological CHATO intervention to reduce BPSD in residents with dementia across long-term care settings.",2021,"The Changing Talk (CHAT) training educates staff about effective, person-centered communication strategies and reduces elderspeak by staff and subsequent BPSD among residents.","['dementia in nursing home care', 'persons living with dementia', 'residents with dementia across long-term care settings', 'Nursing homes (N\u202f=\u202f128']","['Nursing home (NH) care', 'adapted online version (CHATO']",[],"[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",[],128.0,0.0337142,"The Changing Talk (CHAT) training educates staff about effective, person-centered communication strategies and reduces elderspeak by staff and subsequent BPSD among residents.","[{'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'University of Kansas Medical Center School of Nursing, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: Kwilliams1@kumc.edu.'}, {'ForeName': 'Carissa K', 'Initials': 'CK', 'LastName': 'Coleman', 'Affiliation': 'University of Kansas Medical Center School of Nursing, 3901 Rainbow Blvd, Kansas City, KS 66160, USA.'}, {'ForeName': 'Clarissa A', 'Initials': 'CA', 'LastName': 'Shaw', 'Affiliation': 'University of Iowa College of Nursing, 50 Newton Rd, Iowa City, IA 52242, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Perkhounkova', 'Affiliation': 'University of Iowa College of Nursing, 50 Newton Rd, Iowa City, IA 52242, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'University of Iowa College of Nursing, 50 Newton Rd, Iowa City, IA 52242, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Cramer', 'Affiliation': 'University of Kansas Medical Center School of Nursing, 3901 Rainbow Blvd, Kansas City, KS 66160, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Beachy', 'Affiliation': 'University of Iowa College of Public Health, 200 Newton Rd, Iowa City, IA 52242, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Berkley', 'Affiliation': 'University of Kansas Medical Center School of Nursing, 3901 Rainbow Blvd, Kansas City, KS 66160, USA.'}, {'ForeName': 'Michalis', 'Initials': 'M', 'LastName': 'Kantartjis', 'Affiliation': 'University of Iowa Interdisciplinary Graduate Program in Health Informatics, 201 Gilmore Hall, Iowa City, IA 52242, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106550']
1467,34482412,Pulmonary Recruitment Maneuver Reduces Shoulder Pain and Nausea After Laparoscopic Cholecystectomy: A Randomized Controlled Trial.,"BACKGROUND


Pain and nausea are common after laparoscopic surgery. This prospective, randomized, controlled trial aimed to investigate postoperative pain and as a secondary endpoint nausea, when performing a ventilator-piloted Pulmonary Recruitment Maneuvre (PRM) at the end of laparoscopic cholecystectomy.
METHOD


Patients having elective laparoscopic cholecystectomy were randomized to either ordinary exsufflation or ventilator-piloted PRM, to evacuate intra-abdominal carbon dioxide (CO 2 ) before abdominal closure. A questionnaire with numeric rating scales (NRS) was utilized to evaluate pain and nausea at five occasions during 48 h following surgery. Analgesic and antiemetic treatment was also analyzed.
RESULTS


147 patients were analyzed, 76 receiving PRM and 71 controls. Overall pain was well controlled, with no significant difference between the groups regarding incidence (P=0.149) nor intensity (P=0.739). Incidence of shoulder pain was lower in the PRM group during the 48 postoperative hours, 44.7% versus 63.4% (P=0.023). The number needed to treat (NNT) to reduce shoulder pain was 6 (95% Confidence Interval, CI, 2.9-35.5) for the 48-h period. Incidence of nausea was lower in the PRM group during the 48-h period, 51.3% versus 70.4% (P=0.018). NNT was 6 (95% CI 2.9-27.4) for the 48-h period. Nausea intensity was lower in the PRM group during the 48 h (P=0.025). Fewer in the PRM population required antiemetics, 25.0% versus 42.3% (P=0.027).
CONCLUSION


A ventilator-piloted PRM at the end of laparoscopic cholecystectomy reduced incidence of shoulder pain, and incidence and intensity of nausea. Clinical trial registration www.clinicaltrials.gov . Identifier: NCT03026543.",2021,"Overall pain was well controlled, with no significant difference between the groups regarding incidence (P=0.149) nor intensity (P=0.739).","['Patients having elective laparoscopic cholecystectomy', '147 patients were analyzed, 76 receiving PRM and 71 controls']","['Laparoscopic Cholecystectomy', 'ordinary exsufflation or ventilator-piloted PRM, to evacuate intra-abdominal carbon dioxide (CO 2 ) before abdominal closure', 'PRM']","['shoulder pain', 'pain and nausea', 'Shoulder Pain and Nausea', 'shoulder pain, and incidence and intensity of nausea', 'Incidence of nausea', 'Overall pain', 'Nausea intensity', 'Incidence of shoulder pain']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",147.0,0.184804,"Overall pain was well controlled, with no significant difference between the groups regarding incidence (P=0.149) nor intensity (P=0.739).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kihlstedt Pasquier', 'Affiliation': 'Department of Surgery, Vrinnevi Hospital, Gamla Övägen 25, 603 79, Norrköping, Sweden. kihlstedt@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Department of Surgery and Department of Clinical and Experimental Medicine, Linköping University, Norrköping, Sweden.'}]",World journal of surgery,['10.1007/s00268-021-06262-6']
1468,34465252,Long-term safety and efficacy of dimethyl fumarate for up to 13 years in patients with relapsing-remitting multiple sclerosis: Final ENDORSE study results.,"BACKGROUND


Dimethyl fumarate (DMF) demonstrated favorable benefit-risk in relapsing-remitting multiple sclerosis (RRMS) patients in phase-III DEFINE and CONFIRM trials, and ENDORSE extension.
OBJECTIVE


The main aim of this study is assessing DMF safety/efficacy up to 13 years in ENDORSE.
METHODS


Randomized patients received DMF 240 mg twice daily or placebo (PBO; Years 0-2), then DMF (Years 3-10; continuous DMF/DMF or PBO/DMF); maximum follow-up (combined studies), 13 years.
RESULTS


By January 2020, 1736 patients enrolled/dosed in ENDORSE (median follow-up 8.76 years (ENDORSE range: 0.04-10.98) in DEFINE/CONFIRM and ENDORSE); 52% treated in ENDORSE for ⩾6 years. Overall, 551 (32%) patients experienced serious adverse events (mostly multiple sclerosis (MS) relapse or fall; one progressive multifocal leukoencephalopathy); 243 (14%) discontinued treatment due to adverse events (4% gastrointestinal (GI) disorders). Rare opportunistic infections, malignancies, and serious herpes zoster occurred, irrespective of lymphocyte count. For DMF/DMF ( n  = 501), overall annualized relapse rate (ARR) remained low (0.143 (95% confidence interval (CI), 0.120-0.169)), while for PBO/DMF ( n  = 249), ARR decreased after initiating DMF and remained low throughout (ARR 0-2 years, 0.330 (95% CI, 0.266-0.408); overall ARR (ENDORSE, 0.151 (95% CI, 0.118-0.194)). Over 10 years, 72% DMF/DMF and 73% PBO/DMF had no 24-week confirmed disability worsening.
CONCLUSION


Sustained DMF safety/efficacy was observed in patients followed up to 13 years, supporting DMF's positive benefit/risk profile for long-term RRMS treatment.",2021,"For DMF/DMF ( n  = 501), overall annualized relapse rate (ARR) remained low (0.143 (95% confidence interval (CI), 0.120-0.169)), while for PBO/DMF ( n  = 249), ARR decreased after initiating DMF and remained low throughout (ARR 0-2 years, 0.330 (95% CI, 0.266-0.408); overall ARR (ENDORSE, 0.151 (95% CI, 0.118-0.194)).","['patients with relapsing-remitting multiple sclerosis', 'By January 2020, 1736 patients enrolled/dosed in ENDORSE (median follow-up 8.76\u2009years (ENDORSE range: 0.04-10.98) in DEFINE/CONFIRM and ENDORSE); 52% treated in ENDORSE for ⩾6\u2009years']","['DMF 240 mg twice daily or placebo', 'Dimethyl fumarate (DMF', 'DMF (Years 3-10; continuous DMF/DMF or PBO/DMF); maximum follow-up (combined studies), 13\u2009years', 'dimethyl fumarate']","['overall annualized relapse rate (ARR', 'overall ARR', 'DMF safety/efficacy', 'serious adverse events', 'ARR', 'PBO/DMF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517407', 'cui_str': '0.04'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3556566', 'cui_str': 'dimethyl fumarate 240 MG [Tecfidera]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",1736.0,0.0960172,"For DMF/DMF ( n  = 501), overall annualized relapse rate (ARR) remained low (0.143 (95% confidence interval (CI), 0.120-0.169)), while for PBO/DMF ( n  = 249), ARR decreased after initiating DMF and remained low throughout (ARR 0-2 years, 0.330 (95% CI, 0.266-0.408); overall ARR (ENDORSE, 0.151 (95% CI, 0.118-0.194)).","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gold', 'Affiliation': 'Department of Neurology, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute-Hospital, McGill University and NeuroRx Research, Montreal, QC, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'Center for Neuroinflammation and Experimental Therapeutics, Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Fox', 'Affiliation': 'Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Mokliatchouk', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lyons', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/13524585211037909']
1469,34467834,"Effect of resveratrol administration on ovarian morphology, determined by transvaginal ultrasound for the women with polycystic ovary syndrome (PCOS).","Intake of resveratrol has been associated with improved ovarian morphology under in vitro and in the animal models; however, this finding has not been confirmed in trials. The aim of our study was, therefore, to use a placebo-controlled approach with the detailed assessment of the ovarian morphology by applying transvaginal ultrasound to examine the effectiveness of this therapeutic approach in this group of women. The mean age of all participants was 28·61 (sd 4·99) years, with the mean BMI of 28·26 (sd 5·62) kg/m2. Resveratrol therapy, as compared with placebo, was associated with a significantly higher rate of improvement in the ovarian morphology (P = 0·02). Women who received resveratrol had a more dominant follicle than those getting placebo, with a significant reduction in the ovarian volume (P < 0·05). However, the number of follicle count per ovary (FNPO), stromal area (SA), ovarian echogenicity and distribution of follicles were not significantly altered (P > 0·05). Forty-one women with polycystic ovary syndrome (PCOS) were randomly assigned (1:1) to 3 months of daily 1000 mg resveratrol or placebo. Random assignment was done by blocked randomisation. Our primary endpoints were the change in the ovarian volume, SA and antral FNPO from the baseline to 3 months. Secondary endpoints were improvement in the distribution of follicles and ovarian echogenicity. Differences between the resveratrol and control groups were evaluated by Chi-square, Fisher's exact test and repeated-measures ANOVA. Treatment with resveratrol significantly reduced the ovarian volume and polycystic ovarian morphology, thus suggesting a disease-modifying effect in PCOS.",2021,"However, the number of FNPO, stromal area, ovarian echogenicity and distribution of follicles were not significantly altered (P>0.05).
","['Forty-one women with polycystic ovary syndrome (PCOS', 'The mean age of all participants was 28.61 ± 4.99 years, with the mean BMI of 28.26 ± 5.62 kg/m2', 'group of women', 'women with PCOS']","['daily 1000 mg resveratrol or placebo', 'placebo', 'resveratrol administration']","['ovarian volume and PCOM', 'number of FNPO, stromal area, ovarian echogenicity and distribution of follicles', 'ovarian morphology', 'distribution of follicles and ovarian echogenicity', 'ovarian volume', 'change in the ovarian volume, stromal area and antral follicle count per ovary (FNPO']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0029939', 'cui_str': 'Ovarian structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}]",41.0,0.309208,"However, the number of FNPO, stromal area, ovarian echogenicity and distribution of follicles were not significantly altered (P>0.05).
","[{'ForeName': 'Amir Pejman', 'Initials': 'AP', 'LastName': 'Hashemi Taheri', 'Affiliation': 'Radiology Department, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Moradi', 'Affiliation': 'Department of Radiology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Radmard', 'Affiliation': 'Radiology Department, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Sanginabadi', 'Affiliation': 'Radiology Department, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Qorbani', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohajeri-Tehrani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Shirzad', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Hosseini', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Asadi', 'Affiliation': ""Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Samadi', 'Affiliation': 'Radiology Department, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Asieh', 'Initials': 'A', 'LastName': 'Mansour', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",The British journal of nutrition,['10.1017/S0007114521003330']
1470,34469801,Randomized control trial of unconditional versus conditional incentives to increase study enrollment rates in participants at increased risk of lung cancer.,"INTRODUCTION


Understanding how incentives and their timing influence study enrollment rates is important to efficient study design and increasing the generalizability of findings. This 2-arm, parallel randomized trial evaluated how conditional vs. unconditional mailed incentives of a $20 gift card affected study enrollment in a sample of participants screened for lung cancer screening.
METHODS


Eligible participants included Black and White adults who underwent lung cancer screening with low-dose CT and had negative screening results at two North Carolina imaging facilities in 2018. We used a stratified randomization scheme, by sex and race, to assign incentive type (conditional vs. unconditional). We used the Tailored Design Method with six points of mailed contact to engage participants. We compared study enrollment rates using chi-square tests and logistic regression analyses.
RESULTS


After adjusting for sex, race, age, smoking status, participant residence, and screening site, participants who received unconditional incentives were 74% more likely to enroll than those who received conditional incentives (adjusted OR = 1.74 (95% CI: 1.01, 3.00).
CONCLUSIONS


Type of incentive can play a role in increasing study enrollment, especially mailed surveys that target individuals who currently or previously smoked. Unconditional incentives may be worth the initial cost to engage study participants.",2021,"After adjusting for sex, race, age, smoking status, participant residence, and screening site, participants who received unconditional incentives were 74% more likely to enroll than those who received conditional incentives (adjusted OR= 1.74 (95% CI: 1.01, 3.00).
","['Eligible participants included Black and White adults who underwent lung cancer screening with low-dose CT and had negative screening results at two North Carolina imaging facilities in 2018', 'unconditional mailed incentives of a $20 gift card affected study enrollment in a sample of participants screened for lung cancer screening', 'Participants at Increased Risk of Lung Cancer']",[],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0016999', 'cui_str': 'Gamete intrafallopian transfer'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]",[],[],,0.148265,"After adjusting for sex, race, age, smoking status, participant residence, and screening site, participants who received unconditional incentives were 74% more likely to enroll than those who received conditional incentives (adjusted OR= 1.74 (95% CI: 1.01, 3.00).
","[{'ForeName': 'Anjali D', 'Initials': 'AD', 'LastName': 'Kumar', 'Affiliation': 'Department of Epidemiology, University of North Carolina, Chapel Hill. Electronic address: anjali.kumar@unc.edu.'}, {'ForeName': 'Danielle D', 'Initials': 'DD', 'LastName': 'Durham', 'Affiliation': 'Department of Radiology, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Lane', 'Affiliation': 'Department of Radiology, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Pasangi', 'Initials': 'P', 'LastName': 'Perera', 'Affiliation': 'Department of Radiology, University of North Carolina, Chapel Hill.'}, {'ForeName': 'M Patricia', 'Initials': 'MP', 'LastName': 'Rivera', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of North Carolina, Chapel Hill; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Henderson', 'Affiliation': 'Department of Epidemiology, University of North Carolina, Chapel Hill; Department of Radiology, University of North Carolina, Chapel Hill; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2021.08.027']
1471,34469795,LED/laser photoactivation enhances the whitening efficacy of low concentration hydrogen peroxide without microstructural enamel changes.,"BACKGROUND


The association of low concentration hydrogen peroxide (HP) and a light source has been widely used to achieve efficient bleaching. We investigated the colorimetric and microstructural changes of bovine enamel bleached with 6% HP associated or not with a hybrid light source system of violet light and laser (LED/laser).
METHODS


Twenty bovine crowns were used to obtain specimens of 7 × 7 × 2 mm. Then, they were randomized in two groups (n=10): 6% HP and 6% HP + LED/laser. After staining with dark tea solution, three bleaching sessions were performed. Colorimetric evaluation (∆L*, ∆a*, ∆b*, ∆E 00  [CIEDE2000] and WI D ) after 24 hours of each session and 7 days after the final bleaching session was performed. Enamel Vickers microhardness at baseline, 24 hours and 7 days after the last bleaching session were also evaluated. Two-way repeated measures ANOVA and Bonferroni post-test was used at a significance level of 5%.
RESULTS


6% HP and 6% + HP LED/laser showed satisfactory bleaching results. The group photoactivated showed higher WI D  values (p<0.05). Differences between groups were observed for ∆E 00 , ∆L* and ∆a* (p<0.05), except for ∆b* (p>0.05). Intra-group differences were also found (p<0.05). Regarding microhardness, no inter or intra-group differences were observed (p>0.05).
CONCLUSIONS


The photoactivation with LED/laser enhanced the whitening efficacy of 6% HP compared to the group without photoactivation. Thus, the LED/laser activation appears to be a good option when using low concentration HP-based agents. In addition, both bleaching protocols did not cause changes on enamel microhardness.",2021,"Differences between groups were observed for ∆E 00 , ∆L* and ∆a",['Twenty bovine crowns were used to obtain specimens of 7\u202f×\u202f7\u202f×\u202f2 mm'],"['low concentration hydrogen peroxide (HP', 'violet light and laser (LED/laser', '6% HP and 6% HP\u202f+\u202fLED/laser']","['enamel microhardness', 'higher WI D  values', 'whitening efficacy']","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0284654,"Differences between groups were observed for ∆E 00 , ∆L* and ∆a","[{'ForeName': 'Joatan Lucas de Sousa Gomes', 'Initials': 'JLSG', 'LastName': 'Costa', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Araraquara, São Paulo State University - UNESP, 3rd floor, Humaitá Street, 1680 - Centro, Mail Box: 331, Araraquara, São Paulo 14801-903, Brazil. Electronic address: joatan_costa@hotmail.com.'}, {'ForeName': 'João Felipe', 'Initials': 'JF', 'LastName': 'Besegato', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Araraquara, São Paulo State University - UNESP, 3rd floor, Humaitá Street, 1680 - Centro, Mail Box: 331, Araraquara, São Paulo 14801-903, Brazil. Electronic address: besegato@outlook.com.'}, {'ForeName': 'Joissi Ferrari', 'Initials': 'JF', 'LastName': 'Zaniboni', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Araraquara, São Paulo State University - UNESP, 3rd floor, Humaitá Street, 1680 - Centro, Mail Box: 331, Araraquara, São Paulo 14801-903, Brazil. Electronic address: joissizaniboni@gmail.com.'}, {'ForeName': 'Milton Carlos', 'Initials': 'MC', 'LastName': 'Kuga', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Araraquara, São Paulo State University - UNESP, 3rd floor, Humaitá Street, 1680 - Centro, Mail Box: 331, Araraquara, São Paulo 14801-903, Brazil. Electronic address: milton.kuga@unesp.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102511']
1472,34475473,Selective T 3 -T 4  sympathicotomy versus gray ramicotomy on outcome and quality of life in hyperhidrosis patients: a randomized clinical trial.,"Compensatory hyperhidrosis is the leading cause of patients' dissatisfaction after thoracic sympathicotomy. The study aimed to reduce compensatory hyperhidrosis to increase patients' satisfaction. A prospective randomized study on palmar hyperhidrosis, May 2016-September 2019. Twenty-one patients T 3 -T 4  sympathicotomy and 21 T 3 -T 4  gray ramicotomy. Data prospectively collected. Analysis at study's end. Focus on the sweating, temperature, quality of life baseline and postoperatively, compensatory hyperhidrosis, hand dryness, patients' satisfaction, and if they would undergo the procedure again and recommend it. No baseline differences between groups. Hyperhidrosis was controlled postoperatively in all patients. No mortality, serious complications, or recurrences. Sympathicotomy worse postoperative quality of life (49.05 (SD: 15.66, IR: 35.50-63.00) versus ramicotomy 24.30 (SD: 6.02, IR: 19.75-27.25). After ramicotomy, some residual sweating on the face, hands, and axillae. Compensatory sweating worse with sympathicotomy. Satisfaction higher with ramicotomy. Better results with ramicotomy than sympathicotomy regarding hand dryness, how many times a day the patients had to shower or change clothes, intention to undergo the procedure again or recommend it to somebody else, and how bothersome compensatory hyperhidrosis was. T 3 -T 4  gray ramicotomy had better results than T 3 -T 4  sympathicotomy, with less compensatory sweating and higher patients' satisfaction.",2021,"T 3 -T 4  gray ramicotomy had better results than T 3 -T 4  sympathicotomy, with less compensatory sweating and higher patients' satisfaction.","['palmar hyperhidrosis, May 2016-September 2019', 'hyperhidrosis patients']","['Selective T 3 -T 4  sympathicotomy versus gray ramicotomy', 'ramicotomy']","['Compensatory sweating', ""sweating, temperature, quality of life baseline and postoperatively, compensatory hyperhidrosis, hand dryness, patients' satisfaction"", 'postoperative quality of life', 'compensatory sweating', 'No mortality, serious complications, or recurrences', 'quality of life']","[{'cui': 'C1184147', 'cui_str': 'Palmar'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0556636', 'cui_str': 'Gy'}]","[{'cui': 'C1735334', 'cui_str': 'Compensatory sweating'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1274746', 'cui_str': 'Compensatory hyperhidrosis'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.06674,"T 3 -T 4  gray ramicotomy had better results than T 3 -T 4  sympathicotomy, with less compensatory sweating and higher patients' satisfaction.","[{'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Vanaclocha', 'Affiliation': 'Department of Neurosurgery, Hospital General Universitario de Valencia and Department of Surgery, Faculty of Medicine, University of Valencia, Avenida Blasco Ibáñez 15, 46010, Valencia, Spain. vvanaclo@hotmail.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Guijarro-Jorge', 'Affiliation': 'Department of Thoracic Surgery, Hospital General Universitario de Valencia and Department of Surgery, Faculty of Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Nieves', 'Initials': 'N', 'LastName': 'Saiz-Sapena', 'Affiliation': 'Department of Anesthesiology, Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Granell-Gil', 'Affiliation': 'Department of Anesthesiology, Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Ortiz-Criado', 'Affiliation': 'Instituto de Medicina Legal de Valencia (IMLV) and Department of Anatomy, Faculty of Medicine, Catholic University St. Vincent Martyr of Valencia, Valencia, Spain.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Mascarós', 'Affiliation': 'Mathematician With a Master in Statistics, Department of Statistics, Research Foundation, Hospital General Universitario, Valencia, Spain.'}, {'ForeName': 'Leyre', 'Initials': 'L', 'LastName': 'Vanaclocha', 'Affiliation': 'Medical School, University College London, London, UK.'}]",Scientific reports,['10.1038/s41598-021-96972-7']
1473,34474006,Influence of Appetite and Perceived Ability to Control Cravings on Excessive Gestational Weight Gain.,"OBJECTIVE


To explore whether appetite is associated with gestational weight gain (GWG) and to assess the effect of perceived ability to control cravings on excessive GWG.
DESIGN


Secondary data analysis.
SETTING


Rochester, New York, United States.
PARTICIPANTS


Women who were pregnant (N = 1,005) and participated in a randomized controlled trial to test the effect of electronically mediated interventions to prevent excessive GWG and postpartum weight retention.
METHODS


We used two questions to assess appetite and perceived ability to control cravings before 28 weeks gestation: ""How would you describe your appetite now compared to times when you are not pregnant?"" and ""How sure are you that you will be able to avoid overeating when you have cravings?"" We conducted logistic regression to assess the relationships between appetite, perceived ability to control cravings, and excessive GWG.
RESULTS


More than 47% of participants gained excessive weight during pregnancy. Approximately 62% of participants reported being hungrier, and more than 42% indicated that they were unsure they could avoid overeating with cravings. Participants who reported similar/less appetite than before pregnancy were less likely to gain excessive weight (p < .05). Participants who were sure they could control cravings were less likely to gain excessive weight (p = .02).
CONCLUSION


Our results show that appetite and perceived ability to control cravings may affect GWG. Additional research is needed to assess if interventions targeting appetite and craving control could limit GWG.",2021,"Participants who were sure they could control cravings were less likely to gain excessive weight (p = .02).
","['Women who were pregnant (N\xa0= 1,005', 'Rochester, New York, United States']",['electronically mediated interventions to prevent excessive GWG and postpartum weight retention'],"['gain excessive weight', 'excessive weight', 'Excessive Gestational Weight Gain', 'appetite', 'gestational weight gain (GWG']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}]","[{'cui': 'C0000765', 'cui_str': 'Excessive weight gain'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}]",,0.182987,"Participants who were sure they could control cravings were less likely to gain excessive weight (p = .02).
","[{'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Groth', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': ''}, {'ForeName': 'Kuan-Lin', 'Initials': 'KL', 'LastName': 'Yeh', 'Affiliation': ''}, {'ForeName': 'I Diana', 'Initials': 'ID', 'LastName': 'Fernandez', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2021.08.097']
1474,34473963,"Preoperative pudendal block with liposomal and plain bupivacaine reduces pain associated with posterior colporrhaphy: a double-blinded, randomized controlled trial.","BACKGROUND


Pelvic reconstructive surgery may cause significant postoperative pain, especially with posterior colporrhaphy, contributing to a longer hospital stay and increased pain medication utilization. Regional blocks are being increasingly utilized in gynecologic surgery to improve postoperative pain and decrease opioid usage, yet preoperative pudendal blocks have not been used routinely during posterior colporrhaphy.
OBJECTIVE


This study aimed to compare the effect of preoperative regional pudendal nerve block using a combination of 1.3% liposomal and 0.25% plain bupivacaine vs 0.25% plain bupivacaine alone on vaginal pain after posterior colporrhaphy on postoperative days 1, 2, and 3. We hypothesized that there would be a reduction in vaginal pain scores for the study group vs the control group over the first 72 hours.
STUDY DESIGN


This was a double-blinded, randomized controlled trial that included patients undergoing a posterior colporrhaphy, either independently or in conjunction with other vaginal or abdominal reconstructive procedures. Patients were block randomized to receive 20 mL of either a combination of 1.3% liposomal and 0.25% plain bupivacaine (study) or 20 mL of 0.25% plain bupivacaine (control) in a regional pudendal block before the start of surgery. Double blinding was achieved by covering four 5-mL syringes containing the randomized local anesthetic. After induction of anesthesia, a pudendal nerve block was performed per standard technique (5 mL superiorly and 5 mL inferiorly each ischial spine) using a pudendal kit. The primary outcome was to evaluate postoperative vaginal pain using a visual analog scale on postoperative days 1, 2, and 3. Secondary outcomes included total analgesic medication usage through postoperative day 3, postoperative voiding and defecatory dysfunction, and impact of vaginal pain on quality of life factors.
RESULTS


A total of 120 patients were enrolled (60 in each group). There were no significant differences in demographic data, including baseline vaginal pain (P=.88). Postoperative vaginal pain scores were significantly lower in the combined liposomal and bupivacaine group at all time points vs the plain bupivacaine group. Median pain scores for the study and control groups, respectively, were 0 (0-2) and 2 (0-4) for postoperative day 1 (P=.03), 2 (1-4) and 3 (2-5) for postoperative day 2 (P=.05), and 2 (1-4) and 3 (2-5) for postoperative day 3 (P=.02). Vaginal pain scores increased from postoperative day 1 to postoperative days 2 and 3 in both groups. There was a significant decrease in ibuprofen (P=.01) and acetaminophen (P=.03) usage in the study group; however, there was no difference between groups in total opioid consumption through postoperative day 3 (P=.82). There was no difference in successful voiding trials (study 72%, control 82%, P=.30), return of bowel function (P>.99), or quality of life factors (sleep, stress, mood, and activity).
CONCLUSION


Preoperative regional pudendal block with a combination of liposomal and plain bupivacaine provided more effective vaginal pain control than plain bupivacaine alone for reconstructive surgery that included posterior colporrhaphy. Given the statistically significant decrease in vaginal pain in the study group, this block may be considered as a potential adjunct for multimodal pain reduction in this patient population.",2021,"There was no difference in successful voiding trials (study 72%, control 82%, p=.30), return of bowel function (p>.99), or quality of life factors (sleep, stress, mood, and activity).
","['patients undergoing a posterior colporrhaphy, either independently or in conjunction with other vaginal or abdominal reconstructive procedures', 'One hundred and twenty patients were enrolled (60 in each group', 'reconstructive surgery that included posterior colporrhaphy', 'pain associated with posterior colporrhaphy']","['plain bupivacaine', 'ibuprofen', 'liposomal and plain bupivacaine', 'combination of 1.3% liposomal and 0.25% plain bupivacaine (study) or 20ml of 0.25% plain bupivacaine (control', 'acetaminophen', 'bupivacaine', 'preoperative regional pudendal nerve block using a combination of 1.3% liposomal and 0.25% plain bupivacaine']","['total analgesic medication usage through POD 3, postoperative voiding and defecatory dysfunction, in addition to the impact of vaginal pain on quality of life factors', 'postoperative vaginal pain using a visual analog scale on POD 1, 2, and 3', 'vaginal pain scores', 'return of bowel function (p>.99), or quality of life factors (sleep, stress, mood, and activity', 'successful voiding trials', 'Vaginal pain scores', 'total opioid consumption', 'effective vaginal pain control', 'Median pain scores', 'demographic data including baseline vaginal pain', 'vaginal pain', 'Postoperative vaginal pain scores', 'POD 2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0195230', 'cui_str': 'Posterior repair of vagina'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0236082', 'cui_str': 'Vaginal pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",120.0,0.384698,"There was no difference in successful voiding trials (study 72%, control 82%, p=.30), return of bowel function (p>.99), or quality of life factors (sleep, stress, mood, and activity).
","[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Dengler', 'Affiliation': 'Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, MD. Electronic address: katidengler13@gmail.com.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Craig', 'Affiliation': 'Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, MD.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'DiCarlo-Meacham', 'Affiliation': 'Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, MD.'}, {'ForeName': 'Eva K', 'Initials': 'EK', 'LastName': 'Welch', 'Affiliation': 'Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, MD.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Brooks', 'Affiliation': 'Department of Research Programs, Walter Reed National Military Medical Center, Bethesda, MD.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Vaccaro', 'Affiliation': 'Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, MD.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Gruber', 'Affiliation': 'Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, MD; Urogynecology Department, Sibley Memorial Hospital, Johns Hopkins Medicine, Washington, DC.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.08.034']
1475,34477812,Matrix structure of dairy products results in different postprandial lipid responses: a randomized crossover trial.,"BACKGROUND


The dairy matrix may influence digestion and absorption of lipids and thereby risk of cardiovascular diseases (CVDs). However, few postprandial studies have compared dairy products that differed only in terms of their matrix.
OBJECTIVES


We aimed to investigate acute 8-h postprandial lipid, glycemic, and appetite responses after intake of isoenergetic dairy meals with different matrixes, but similar nutritional composition.
METHODS


Twenty-five normal-weight men (18-40 y old) were enrolled in a randomized controlled crossover trial. On 4 test days, a meal with 1 of 4 dairy products was served: cheddar cheese (Cheese), homogenized Cheese (Hom. Cheese), micellar casein isolate (MCI) with cream (MCI Drink), and a gel produced from the MCI Drink by addition of Glucono Delta-Lactone (MCI Gel). The fat- and protein-matched dairy products differed in terms of their casein network, fat droplet size, and/or texture. Blood biochemistry and appetite responses were collected.
RESULTS


Eighteen participants completed the trial. Postprandial triglycerides (TGs) (primary outcome) increased by (mean ± SEM) 0.24 ± 0.07 and 0.19 ± 0.07 mmol/L after MCI Gel compared with Cheese and Hom. Cheese, respectively (both P ≤ 0.05). Likewise, MCI Gel increased TG incremental AUC compared with Cheese and Hom. Cheese (both P < 0.05), and peak compared with Cheese (P < 0.05). ApoB-48 (primary outcome) was unaffected by dairy matrix. For free fatty acids (FFAs), glucose, and insulin, time × meal interactions were observed (all P < 0.001). During the first 2 h, FFAs were lower for Cheese than for MCI products, whereas the opposite was observed for glucose and insulin.
CONCLUSIONS


Postprandial TG but not apoB-48 response was higher after MCI Gel, indicating that the type of casein network influences lipid responses. This suggests that the dairy matrix may also affect risk factors for CVDs. Reducing fat droplet size (i.e., Hom. Cheese) did not affect blood biochemistry.This trial was registered at clinicaltrials.gov as NCT03656367.",2021,"For free fatty acids (FFAs), glucose, and insulin, time × meal interactions were observed (all P < 0.001).","['Eighteen participants completed the trial', 'Twenty-five normal-weight men (18-40 y old']","['ApoB-48', 'meal with 1 of 4 dairy products was served: cheddar cheese (Cheese), homogenized Cheese (Hom. Cheese), micellar casein isolate (MCI) with cream (MCI Drink), and a gel produced from the MCI Drink by addition of Glucono Delta-Lactone (MCI Gel']","['free fatty acids (FFAs), glucose, and insulin, time × meal interactions', 'Likewise, MCI Gel increased TG incremental AUC', 'postprandial lipid responses', 'blood biochemistry', 'Postprandial triglycerides (TGs', 'Blood biochemistry and appetite responses']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0103839', 'cui_str': 'Apolipoprotein B-48'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C0452767', 'cui_str': 'Cheddar cheese'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0061387', 'cui_str': 'Gluconolactone'}]","[{'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}]",18.0,0.159139,"For free fatty acids (FFAs), glucose, and insulin, time × meal interactions were observed (all P < 0.001).","[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kjølbæk', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Jesper M', 'Initials': 'JM', 'LastName': 'Schmidt', 'Affiliation': 'Department of Food Science, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Emilien', 'Initials': 'E', 'LastName': 'Rouy', 'Affiliation': 'Arla Innovation Center, Aarhus, Denmark.'}, {'ForeName': 'Klaus J', 'Initials': 'KJ', 'LastName': 'Jensen', 'Affiliation': 'Arla Innovation Center, Aarhus, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Hanne C', 'Initials': 'HC', 'LastName': 'Bertram', 'Affiliation': 'Department of Food Science, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Hammershøj', 'Affiliation': 'Department of Food Science, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab220']
1476,34483297,Site-Randomized Controlled Trial of a Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among Youth Living With HIV in the United States.,"BACKGROUND


Depression is frequent among youth living with HIV (YLWH). Studies suggest that manualized treatment guided by symptom measurement is more efficacious than usual care.
SETTING


This study evaluated manualized, measurement-guided depression treatment among YLWH, aged 12-24 years at 13 US sites of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network.
METHODS


Using restricted randomization, sites were assigned to either a 24-week, combination cognitive behavioral therapy and medication management algorithm (COMB-R) tailored for YLWH or to enhanced standard of care, which provided standard psychotherapy and medication management. Eligibility included diagnosis of nonpsychotic depression and current depressive symptoms. Arm comparisons used t tests on site-level means.
RESULTS


Thirteen sites enrolled 156 YLWH, with a median of 13 participants per site (range 2-16). At baseline, there were no significant differences between arms on demographic factors, severity of depression, or HIV status. The average site-level participant characteristics were as follows: mean age of 21 years, 45% male, 61% Black, and 53% acquired HIV through perinatal transmission. At week 24, youth at COMB-R sites, compared with enhanced standard of care sites, reported significantly fewer depressive symptoms on the Quick Inventory for Depression Symptomatology Self-Report (QIDS-SR score 6.7 vs. 10.6, P = 0.01) and a greater proportion in remission (QIDS-SR score ≤ 5; 47.9% vs. 17.0%, P = 0.01). The site mean HIV viral load and CD4 T-cell level were not significantly different between arms at week 24.
CONCLUSIONS


A manualized, measurement-guided psychotherapy and medication management algorithm tailored for YLWH significantly reduced depressive symptoms compared with standard care at HIV clinics.",2021,"The site mean HIV viral load and CD4 T-cell level were not significantly different between arms at Week 24.
","['Youth Living with HIV in the United States', 'YLWH, ages 12-24 years at thirteen United States sites of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT', 'The average site-level participant characteristics were: mean age of 21 years; 45% male, 61% Black, and 53% acquired HIV through perinatal transmission', 'Thirteen sites enrolled 156 YLWH, with a median of 13 participants per site (range 2-16', 'youth living with HIV (YLWH']","['Combined Cognitive Behavioral Therapy and a Medication Management Algorithm', 'psychotherapy and medication management algorithm', 'YLWH', 'combination cognitive behavioral therapy and medication management algorithm (COMB-R) tailored for YLWH or to Enhanced Standard of Care (ESC), which provided standard psychotherapy and medication management']","['depressive symptoms', 'Depression Symptomatology Self-Report', 'demographic factors, severity of depression, or HIV status', 'site mean HIV viral load and CD4 T-cell level']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376161', 'cui_str': 'Comb'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011292', 'cui_str': 'Demographic Factors'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",156.0,0.101853,"The site mean HIV viral load and CD4 T-cell level were not significantly different between arms at Week 24.
","[{'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Chernoff', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Betsy D', 'Initials': 'BD', 'LastName': 'Kennard', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas, TX.'}, {'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'Emslie', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas, TX.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lypen', 'Affiliation': 'FHI 360, Durham, NC.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Buisson', 'Affiliation': 'FHI 360, Durham, NC.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weinberg', 'Affiliation': ""Pediatrics-Infectious Diseases, School of Medicine, University of Colorado, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Whiteley', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Traite', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Krotje', 'Affiliation': 'Frontier Science Foundation, Amherst, NY.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Harriff', 'Affiliation': 'Frontier Science Foundation, Amherst, NY.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Townley', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Bunch', 'Affiliation': ""Pediatrics-Infectious Diseases, School of Medicine, University of Colorado, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Murli', 'Initials': 'M', 'LastName': 'Purswani', 'Affiliation': 'BronxCare Health System, Division of Pediatric Infectious Disease, Icahn School of Medicine at Mount Sinai, Bronx, NY.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Shaw', 'Affiliation': 'Jacobi Medical Center, Bronx, NY.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Spector', 'Affiliation': 'Division of Pediatric Infectious Diseases, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Agwu', 'Affiliation': 'Pediatric Infectious Diseases, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Shapiro', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002790']
1477,34482211,Associations between duration of active second stage of labour and adverse maternal and neonatal outcomes: A cohort study of nulliparous women with spontaneous onset of labour.,"OBJECTIVE


To investigate associations between the duration of the active second stage of labour and adverse maternal and neonatal outcomes.
METHOD


This cohort study is based on data from a cluster randomised controlled trial (RCT) undertaken at 14 Norwegian birth clinics in Norway from 2014 to 2017. The final sample involved 6804 nulliparous women with a singleton fetus, cephalic presentation, spontaneous onset of labour at term, vaginal delivered and with an active second stage of labour. The women were grouped to active second stage of labour ≤ 60 min and active second stage of labour > 60 min. Binary logistic regression was used to estimate crude and adjusted odds ratios (ORs) of the maternal and neonatal outcomes with an associated 95% confidence intervals (CIs), comparing women in the two groups.
RESULTS


There was an increased risk of postpartum haemorrhage > 1000 ml with an adjusted OR 1.31 (95% CI: 1.01-1.69) when the active second stage of labour exceeded 60 min. There was no significant difference in the risk of obstetric anal sphincter injuries (adjusted OR 0.93 [95% CI: 0.65-1.39]), Apgar scores < 7 at 5 min age (adjusted OR 1.13 [95% CI: 0.65-1.97]) or admission to the neonatal intensive care unit (adjusted OR 1.46 [95% CI: 0.61-3.51]) between the study groups.
CONCLUSION


Women with an active second stage of labour that exceeds 60 min had an increased risk of postpartum haemorrhage > 1000 ml. We found no association between duration of active stage of labour and obstetric anal sphincter injuries or adverse neonatal outcomes.",2021,There was no significant difference in the risk of obstetric anal sphincter injuries (adjusted OR 0.93,"['Women with an active second stage of labour', '6804 nulliparous women with a singleton fetus, cephalic presentation, spontaneous onset of labour at term, vaginal delivered and with an active second stage of labour', '14 Norwegian birth clinics in Norway from 2014 to 2017', 'nulliparous women with spontaneous onset of labour']",[],"['duration of active second stage of labour and adverse maternal and neonatal outcomes', 'duration of active stage of labour and obstetric anal sphincter injuries or adverse neonatal outcomes', 'Apgar scores', 'risk of postpartum haemorrhage\xa0', 'risk of obstetric anal sphincter injuries']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1142258', 'cui_str': 'Anal sphincter injury'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}]",6804.0,0.152333,There was no significant difference in the risk of obstetric anal sphincter injuries (adjusted OR 0.93,"[{'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Dalbye', 'Affiliation': 'Department of Obstetrics and Gynaecology, Østfold Hospital Trust, Gralum, Norway; Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway. Electronic address: rebecka.dalbye@so-hf.no.'}, {'ForeName': 'Ingvill', 'Initials': 'I', 'LastName': 'Aursund', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Volent', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Moe Eggebø', 'Affiliation': 'National Centre for Fetal Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Obstetrics and Gynaecology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Pal', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital of North Norway, Norway, Tromsø, Norway.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Bernitz', 'Affiliation': 'Department of Obstetrics and Gynaecology, Østfold Hospital Trust, Gralum, Norway; Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway.'}]",Sexual & reproductive healthcare : official journal of the Swedish Association of Midwives,['10.1016/j.srhc.2021.100657']
1478,34481881,Anodal tDCS accelerates on-line learning of dart throwing.,"Transcranial direct current stimulation (tDCS) has been shown to enhance or block online learning of motor skills, depending on the current direction. However, most research on the use of tDCS has been limited to the study of relatively simple motor tasks. The purpose of the present study was to examine the influence of anodal (a-tDCS) and cathodal (c-tDCS) direct current stimulation on the online learning during a single session of dart throwing. Fifty-eight young adults were randomized to a-tDCS, c-tDCS, or SHAM groups and completed a pre-test block of dart throws, a 20-minute practice block of throws while receiving their stimulation condition, and a post-test block of dart throws. The results showed that a-tDCS accelerated the skill learning of dart throwing more than SHAM and c-tDCS conditions. The SHAM and c-tDCS conditions were not different. We conclude that a-tDCS may have a positive effect in a single training session which would be ideal in a recreational game environment where repeated practice is not common.",2021,The results showed that a-tDCS accelerated the skill learning of dart throwing more than SHAM and c-tDCS conditions.,['Fifty-eight young adults'],"['anodal (a-tDCS) and cathodal (c-tDCS) direct current stimulation', 'tDCS, c-tDCS, or SHAM groups and completed a pre-test block of dart throws, a 20-minute practice block of throws while receiving their stimulation condition, and a post-test block of dart throws', 'Transcranial direct current stimulation (tDCS', 'tDCS']","['Anodal tDCS accelerates on-line learning of dart throwing', 'skill learning']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0336707', 'cui_str': 'Dart'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0336707', 'cui_str': 'Dart'}]",58.0,0.0704114,The results showed that a-tDCS accelerated the skill learning of dart throwing more than SHAM and c-tDCS conditions.,"[{'ForeName': 'Anthony W', 'Initials': 'AW', 'LastName': 'Meek', 'Affiliation': 'School of Health and Human Sciences, Indiana University Purdue University Indianapolis, Indianapolis, IN, USA.'}, {'ForeName': 'Davin', 'Initials': 'D', 'LastName': 'Greenwell', 'Affiliation': 'School of Health and Human Sciences, Indiana University Purdue University Indianapolis, Indianapolis, IN, USA.'}, {'ForeName': 'Brach', 'Initials': 'B', 'LastName': 'Poston', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Riley', 'Affiliation': 'School of Health and Human Sciences, Indiana University Purdue University Indianapolis, Indianapolis, IN, USA. Electronic address: zariley@iu.edu.'}]",Neuroscience letters,['10.1016/j.neulet.2021.136211']
1479,34487875,"Influence of methylthioninium chloride, curcumin and Er, Cr: YSGG on caries affected dentin bonded to bioactive and conventional bulk fill dental restorative material.","AIM


The study aimed to determine the influence of Er, Cr: YSGG (ECL), methylene blue photosensitizer (MBP), and curcumin photosensitizer (CP) disinfection on CAD and its bond strength and microleakage to bioactive (BA) and multicore (MC) bulk-fill composite.
MATERIALS AND METHODS


Sixty carious mandibular molars were collected based on the criteria of ICDAS Code 6 (International Caries Detection and Assessment system). Specimens were embedded in polyvinyl pipes up to CEJ and subjected to preparation of standard class II cavity leaving CAD in situ for bonding. All samples were randomly assigned to eight groups based on disinfection regimes and type of bulk-fill material. Samples in group 5 and 6 didn't undergo any disinfection; group 1: ECL + BA, group 2: ECL+ MC; group 3 MBP + BA, group 4: MBP + MC; group 5: Conventional Etch and Rinse + BA (Control), group 6 Conventional Etch and Rinse + MC (Control); group 7: CP +BA and group 8 CP+MC. Specimens were tested for SBS using a universal testing machine and the debonded surfaces were evaluated under a stereomicroscope to determine modes of failure. A dye penetration test was performed for microleakage assessment. For intergroup comparison test analysis of variance (ANOVA) was performed using means and standard deviation from each group. Tukey HSD was used for multiple group comparison tests. The level of significance was established at p < 0.05.
RESULTS


The maximum mean bond strength was shown by group 6 (18.96 ± 0.31 MPa) conventional etch and rinse+ MC (control). Whereas, the minimum SBS was recorded in specimens of group 7 CP +BA (13.04 ± 0.81 MPa). SBS values among group 3 (14.05 ± 0.10 MPa- MBP+BA), group 4 (13.66 ± 0.39- MBP+MC) group 7 (13.04 ± 0.81 MPa- CP +BA and group 8 (14.21 ± 0.59 MPa- CP+MC) were found to be comparable (p>0.05). There was no statistically significant difference among the study groups concerning microleakage (p >0.05).
CONCLUSION


CAD treated with ECL for the adhesive bonding of BA and conventional bulk-fill composite MC has shown potential to be used clinically. Moreover, MBP and CP for conditioning of CAD need further investigation.",2021,The maximum mean bond strength was shown by group 6 (18.96 ± 0.31 MPa) conventional etch and rinse+ MC (control).,"['Sixty carious mandibular molars were collected based on the criteria of ICDAS Code 6 (International Caries Detection and Assessment system', 'caries affected dentin bonded to bioactive and conventional bulk fill dental restorative material']","['ECL', 'MBP\u202f+\u202fMC', 'CP +BA and group 8 CP+MC', 'Er, Cr: YSGG (ECL), methylene blue photosensitizer (MBP), and curcumin photosensitizer (CP) disinfection', 'methylthioninium chloride, curcumin and Er, Cr: YSGG', 'Conventional Etch and Rinse\u202f+\u202fBA (Control), group 6 Conventional Etch and Rinse\u202f+\u202fMC (Control', 'ECL+ MC']","['maximum mean bond strength', 'minimum SBS', 'SBS values', 'CAD and its bond strength and microleakage to bioactive (BA) and multicore (MC']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}]","[{'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}, {'cui': 'C0270962', 'cui_str': 'Multi-core congenital myopathy'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0270962', 'cui_str': 'Multi-core congenital myopathy'}]",60.0,0.0356639,The maximum mean bond strength was shown by group 6 (18.96 ± 0.31 MPa) conventional etch and rinse+ MC (control).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alrahlah', 'Affiliation': 'Department of Restorative Dental Sciences, College of Dentistry, King Saud University, P. O. Box 60169, Riyadh 11545, Saudi Arabia; Engr. Abdullah Bugshan research chair for Dental and Oral Rehabilitation, King Saud University, Riyadh 11545, Saudi Arabia. Electronic address: aalrahlah@ksu.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102512']
1480,34487871,"Ablative fractional laser-assisted photodynamic therapy vs. ablative fractional laser for oral leukoplakia treatment: A randomized, controlled pilot study.","BACKGROUND


Ablative fractional laser-assisted photodynamic therapy (AFL-PDT) is explored as an effective method in some premalignant diseases, whereas the effect of AFL-PDT on oral leukoplakia (OL), the best-known precursor of oral squamous cell carcinoma, remains undetermined.
METHODS


Forty-eight patients, histologically diagnosed with OL, were randomized (1:1) to receive either AFL-PDT or ablative fractional laser (AFL) treatment. All patients were followed up at 1, 3, 6 and 12 months postoperatively. The primary endpoints of efficacy and clinical recurrence and the secondary endpoint of side effects were assessed.
RESULTS


Forty-four patients completed the study. The 100% effective cure rate in the AFL-PDT group was higher than that in AFL group (80.9%, P<0.05) with 19.1% difference (95%CI: 0.7-40.0%). Compared to AFL group, recurrence observed at 6 and 12 months post-treatment tended to occur in fewer patients in the AFL-PDT group (P<0.05). No severe adverse events or systemic side effects were observed in either group.
CONCLUSIONS


AFL-PDT may effectively reduce recurrence of OL with high clinical efficacy and good tolerability, suggesting it may be a promising treatment for OL.",2021,"No severe adverse events or systemic side effects were observed in either group.
","['Forty-four patients completed the study', 'Forty-eight patients, histologically diagnosed with OL']","['AFL', 'Ablative fractional laser-assisted photodynamic therapy vs. ablative fractional laser', 'AFL-PDT', 'AFL-PDT or ablative fractional laser (AFL) treatment', 'Ablative fractional laser-assisted photodynamic therapy (AFL-PDT']","['effective cure rate', 'severe adverse events or systemic side effects', 'recurrence', 'efficacy and clinical recurrence and the secondary endpoint of side effects']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023532', 'cui_str': 'Leukoplakia of oral mucosa'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.101272,"No severe adverse events or systemic side effects were observed in either group.
","[{'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; National Clinical Research Center for Oral Diseases, Shanghai 200011, China; Shanghai Key Laboratory of Stomatology, Shanghai 200011, China.""}, {'ForeName': 'Linjun', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; National Clinical Research Center for Oral Diseases, Shanghai 200011, China; Shanghai Key Laboratory of Stomatology, Shanghai 200011, China.""}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; National Clinical Research Center for Oral Diseases, Shanghai 200011, China; Shanghai Key Laboratory of Stomatology, Shanghai 200011, China.""}, {'ForeName': 'Xuemin', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': ""Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; College of Stomatology, Shanghai Jiao Tong University, Shanghai 200011, China; National Center for Stomatology, Shanghai 200011, China.""}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': ""Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; National Clinical Research Center for Oral Diseases, Shanghai 200011, China; Shanghai Key Laboratory of Stomatology, Shanghai 200011, China.""}, {'ForeName': 'Guoyao', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': ""Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; College of Stomatology, Shanghai Jiao Tong University, Shanghai 200011, China; National Center for Stomatology, Shanghai 200011, China; National Clinical Research Center for Oral Diseases, Shanghai 200011, China; Shanghai Key Laboratory of Stomatology, Shanghai 200011, China.. Electronic address: tanggy@shsmu.edu.cn.""}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; National Clinical Research Center for Oral Diseases, Shanghai 200011, China; Shanghai Key Laboratory of Stomatology, Shanghai 200011, China.. Electronic address: teana_wu@sina.com.""}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102523']
1481,34489189,Implementation and Impact of the Pulmonary Specialist Health Coach Consultation Model to Improve Care for Patients with COPD.,"BACKGROUND


Health coaching has emerged as an important tool for improving patient-centered care in primary care practice but has not specifically been evaluated for patients whose care is shared by a primary care provider (PCP) and specialist.
METHODS


As part of a nine-month randomized controlled trial comparing health coaching to usual care for patients with chronic obstructive pulmonary disease (COPD), the authors developed the Pulmonary Specialist Health Coach Consultation (PuSHCon). In this novel model, health coaches facilitated pulmonary specialist consultations for patients with COPD without the need for an in-person visit. Observational data from the randomized controlled trial were analyzed to study the implementation, adoption, and impact of the PuSHCon model for 70 of 92 patients randomized to the health coaching arm and for 17 of 100 patients in the control arm (who received PuSHCon after the end of the study). Quality of care was measured using the Patient Assessment of Chronic Illness Care (PACIC).
RESULTS


Of 87 patients who participated in PuSHCon, 74 (85.1%) received one or more specialist recommendations, of which 86.8% were implemented. Only 12 patients (13.8%) subsequently required an in-person visit with the PuSHCon specialist. The proportion of PuSHCon participants receiving guideline-concordant care increased from 64.7% to 94.1% (p < 0.001). The mean PACIC item score increased from 3.48 to 3.74 (p = 0.03).
CONCLUSION


The PuSHCon model facilitated consultations that resulted in changes in care, which were implemented for a majority of patients. Guideline-concordant care and patient-reported quality of care increased over nine months. This model could potentially be expanded to help patients with other chronic conditions when PCPs and specialists share patient care.",2021,"The mean PACIC item score increased from 3.48 to 3.74 (p = 0.03).
","['Only 12 patients (13.8%) subsequently required an in-person visit with the PuSHCon specialist', '70 of 92 patients randomized to the health coaching arm and for 17 of 100 patients in the control arm (who received PuSHCon after the end of the study', '87 patients who participated in PuSHCon, 74 (85.1%) received one or more specialist recommendations, of which 86.8% were implemented', 'patients with COPD without the need for an in-person visit', 'Patients with COPD', 'patients with chronic obstructive pulmonary disease (COPD), the authors developed the Pulmonary Specialist Health Coach Consultation (PuSHCon']",['health coaching to usual care'],"['mean PACIC item score', 'quality of care', 'Quality of care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0586859', 'cui_str': 'Pulmonologist'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C3812881', 'cui_str': 'Author'}]","[{'cui': 'C2317129', 'cui_str': 'Health coach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}]",,0.0814326,"The mean PACIC item score increased from 3.48 to 3.74 (p = 0.03).
","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tsao', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Willard-Grace', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Chirinos', 'Affiliation': ''}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'De Vore', 'Affiliation': ''}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Thom', 'Affiliation': ''}]",Joint Commission journal on quality and patient safety,['10.1016/j.jcjq.2021.08.003']
1482,34495285,Effect of Online 1-Day Cognitive Behavioral Therapy-Based Workshops Plus Usual Care vs Usual Care Alone for Postpartum Depression: A Randomized Clinical Trial.,"Importance


Postpartum depression (PPD) affects as many as 20% of mothers, yet just 1 in 10 of these women receives evidence-based treatment. The COVID-19 pandemic has increased PPD risk, reduced treatment access, and shifted preferences toward virtual care.
Objective


To determine whether an online 1-day cognitive behavioral therapy (CBT)-based workshop added to treatment as usual improves PPD, anxiety, social support, mother-infant relationship quality, and infant temperament more than treatment as usual alone.
Design, Setting, and Participants


This randomized clinical trial included 403 women with PPD who were recruited across Ontario, Canada, during the COVID-19 pandemic (April 20 to October 4, 2020). Women with Edinburgh Postnatal Depression Scale (EPDS) scores of at least 10 who were 18 years or older and had an infant younger than 12 months were eligible.
Interventions


Women were randomly assigned to receive a live, interactive online 1-day CBT-based workshop delivered by a registered psychotherapist, psychiatrist, or clinical psychology graduate student in addition to treatment as usual (n = 202) or to receive treatment as usual and wait-listed to receive the workshop 12 weeks later (n = 201).
Main Outcomes and Measures


The primary outcome was change in PPD (EPDS scores) in experimental and wait list control groups 12 weeks after baseline. Secondary outcomes included maternal anxiety (7-item Generalized Anxiety Disorder Questionnaire [GAD-7]), social support (Social Provisions Scale), quality of the mother-infant relationship (Postpartum Bonding Questionnaire), and infant temperament (Infant Behavior Questionnaire-Revised Very Short Form).
Results


Participants all identified as women with a mean (SD) age of 31.8 (4.4) years. The workshop led to significant mean (SD) reductions in EPDS scores (from 16.47 [4.41] to 11.65 [4.83]; B = -4.82; P < .001) and was associated with a higher odds of exhibiting a clinically significant decrease in EPDS scores (odds ratio, 4.15; 95% CI, 2.66-6.46). The mean (SD) GAD-7 scores decreased from 12.41 (5.12) to 7.97 (5.54) after the workshop (B = -4.44; 95% CI, -5.47 to -3.38; P < .001) and participants were more likely to experience a clinically significant change (odds ratio, 3.09; 95% CI, 1.99-4.81). Mothers also reported improvements in bonding (B = -3.22; 95% CI, -4.72 to -1.71; P < .001), infant-focused anxiety (B = -1.64; 95% CI, -2.25 to 1.00; P < .001), social support (B = 3.31; 95% CI, 1.04 to 5.57; P < .001), and positive affectivity/surgency in infants (B = 0.31; 95% CI, 0.05 to 0.56; P < .001).
Conclusions and Relevance


In this randomized clinical trial, an online 1-day CBT-based workshop for PPD provides an effective, brief option for mothers, reducing PPD and anxiety as well as improving social support, the mother-infant relationship, and positive affectivity/surgency in offspring.
Trial Registration


ClinicalTrials.gov Identifier: NCT04485000.",2021,"Mothers also reported improvements in bonding (B = -3.22; 95% CI, -4.72 to -1.71; P < .001), infant-focused anxiety (B = -1.64; 95% CI, -2.25 to 1.00; P < .001), social support (B = 3.31; 95% CI, 1.04 to 5.57; P < .001), and positive affectivity/surgency in infants (B = 0.31; 95% CI, 0.05 to 0.56; P < .001).
","['Results\n\n\nParticipants all identified as women with a mean (SD) age of 31.8 (4.4) years', 'Interventions\n\n\nWomen', 'Women with Edinburgh Postnatal Depression Scale (EPDS) scores of at least 10 who were 18 years or older and had an infant younger than 12 months were eligible', 'Postpartum Depression', '403 women with PPD who were recruited across Ontario, Canada, during the COVID-19 pandemic (April 20 to October 4, 2020']","['online 1-day cognitive behavioral therapy (CBT)-based workshop', 'Online 1-Day Cognitive Behavioral Therapy-Based Workshops Plus Usual Care vs Usual Care Alone', 'live, interactive online 1-day CBT-based workshop delivered by a registered psychotherapist, psychiatrist, or clinical psychology graduate student in addition to treatment as usual (n\u2009=\u2009202) or to receive treatment as usual and wait-listed to receive the workshop 12 weeks later (n\u2009=\u2009201']","['infant-focused anxiety', 'positive affectivity/surgency', 'mean (SD) GAD-7 scores', 'change in PPD (EPDS scores', 'PPD, anxiety, social support, mother-infant relationship quality, and infant temperament', 'social support', 'EPDS scores', 'maternal anxiety (7-item Generalized Anxiety Disorder Questionnaire [GAD-7]), social support (Social Provisions Scale), quality of the mother-infant relationship (Postpartum Bonding Questionnaire), and infant temperament (Infant Behavior Questionnaire-Revised Very Short Form']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0557555', 'cui_str': 'Psychotherapist'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0033912', 'cui_str': 'Clinical Psychology'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0242952', 'cui_str': 'Behavior, Infant'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",403.0,0.50106,"Mothers also reported improvements in bonding (B = -3.22; 95% CI, -4.72 to -1.71; P < .001), infant-focused anxiety (B = -1.64; 95% CI, -2.25 to 1.00; P < .001), social support (B = 3.31; 95% CI, 1.04 to 5.57; P < .001), and positive affectivity/surgency in infants (B = 0.31; 95% CI, 0.05 to 0.56; P < .001).
","[{'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Van Lieshout', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Layton', 'Affiliation': 'Health Research Methodology Graduate Program, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Calan D', 'Initials': 'CD', 'LastName': 'Savoy', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'June S L', 'Initials': 'JSL', 'LastName': 'Brown', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ferro', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Bieling', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Feller', 'Affiliation': 'Public Health and Emergency Services, Regional Municipality of Niagara, Thorold, Ontario, Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hanna', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2021.2488']
1483,34495283,Patient-Centered Decision-making for Postoperative Narcotic-Free Endocrine Surgery: A Randomized Clinical Trial.,"Importance


Historically, opioid pain medications have been overprescribed following thyroid and parathyroid surgery. Many narcotic prescriptions are incompletely consumed, creating waste and opportunities for abuse.
Objective


To determine whether limiting opioid prescriptions after outpatient thyroid and parathyroid surgery to patients who opt in to narcotic treatment reduces opioid consumption without increasing postoperative pain compared with usual care (routine narcotic prescriptions).
Design, Setting, and Participants


A randomized clinical trial of Postoperative Opt-In Narcotic Treatment (POINT) or routine narcotic prescription (control) was conducted at a single tertiary referral center from June 1 to December 30, 2020. A total of 180 adults undergoing ambulatory cervical endocrine surgery, excluding patients currently receiving opioids, were assessed for eligibility. POINT patients received perioperative pain management counseling and were prescribed opioids only on patient request. Patients reported pain scores (0-10) and medication use through 7 daily postoperative surveys. Logistic regression was used to determine factors associated with opioid consumption.
Interventions


Patients in the POINT group were able to opt in or out of receiving prescriptions for opioid pain medication on discharge. Control patients received routine opioid prescriptions on discharge.
Main Outcomes and Measures


Daily peak pain score through postoperative day 7 was the primary outcome. Noninferiority was defined as a difference less than 2 on an 11-point numeric rating scale from 0 to 10. Analysis was conducted on the evaluable population.
Results


Of the 180 patients assessed for eligibility, the final study cohort comprised 102 patients: 48 randomized to POINT and 54 to control. Of these, 79 patients (77.5%) were women and median age was 52 (interquartile range, 43-62) years. A total of 550 opioid tablets were prescribed to the control group, and 230 tablets were prescribed to the POINT group, in which 23 patients (47.9%) opted in for an opioid prescription. None who opted out subsequently required rescue opioids. In the first postoperative week, 17 POINT patients (35.4% of survey responders in the POINT group) reported consuming opioids compared with 27 (50.0%) control patients (P = .16). Median peak outpatient pain scores were 6 (interquartile range, 4-8) in the control group vs 6 (interquartile range, 5-7) in the POINT group (P = .71). In multivariate analysis, patients with a history of narcotic use were 7.5 times more likely to opt in (95% CI, 1.61-50.11; P = .02) and 4.8 times more likely to consume opioids (95% CI, 1.04-1.52; P = .01). Higher body mass index (odds ratio, 1.11; 95% CI, 1.01-1.23; P = .03) and highest inpatient postoperative pain score (odds ratio, 1.24; 95% CI, 1.04-1.52; P = .02) were also associated with opioid consumption.
Conclusions and Relevance


In this trial, an opt-in strategy for postoperative narcotics reduced opioid prescription without increasing pain after cervical endocrine surgery.
Trial Registration


ClinicalTrials.gov Identifier: NCT04710069.",2021,"Higher body mass index (odds ratio, 1.11; 95% CI, 1.01-1.23; P = .03) and highest inpatient postoperative pain score (odds ratio, 1.24; 95% CI, 1.04-1.52; P = .02) were also associated with opioid consumption.
","['180 patients assessed for eligibility, the final study cohort comprised 102 patients: 48 randomized to POINT and 54 to control', 'patients who opt in to narcotic treatment reduces opioid consumption without increasing postoperative pain compared with usual care (routine narcotic prescriptions', '180 adults undergoing', '79 patients (77.5%) were women and median age was 52 (interquartile range, 43-62) years']","['Postoperative Narcotic-Free Endocrine Surgery', 'ambulatory cervical endocrine surgery', 'Narcotic Treatment (POINT) or routine narcotic prescription (control', 'routine opioid prescriptions', 'perioperative pain management counseling', 'Postoperative Opt']","['Main Outcomes and Measures\n\n\nDaily peak pain score', 'Median peak outpatient pain scores', '11-point numeric rating scale', 'Higher body mass index', 'highest inpatient postoperative pain score', 'pain scores']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038900', 'cui_str': 'Operation on endocrine system'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",180.0,0.411397,"Higher body mass index (odds ratio, 1.11; 95% CI, 1.01-1.23; P = .03) and highest inpatient postoperative pain score (odds ratio, 1.24; 95% CI, 1.04-1.52; P = .02) were also associated with opioid consumption.
","[{'ForeName': 'Catherine Y', 'Initials': 'CY', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Schumm', 'Affiliation': 'Department of General Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Theodore X', 'Initials': 'TX', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Dalena T', 'Initials': 'DT', 'LastName': 'Nguyen', 'Affiliation': 'Department of General Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Jiyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics, UCLA School of Public Health, Los Angeles, California.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Anne Y', 'Initials': 'AY', 'LastName': 'Lin', 'Affiliation': 'Department of General Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Yeh', 'Affiliation': 'Department of General Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Masha J', 'Initials': 'MJ', 'LastName': 'Livhits', 'Affiliation': 'Department of General Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'James X', 'Initials': 'JX', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}]",JAMA surgery,['10.1001/jamasurg.2021.4287']
1484,34470816,Comparative Effectiveness of Clinical and Community-Based Approaches to Healthy Weight.,"OBJECTIVES


The objective was to evaluate if 2 pediatric weight management interventions delivered to Hispanic, low-income children (one in a health center the other in a Young Men's Christian Association) were effective in reducing BMI. We hypothesized that they would be equally effective.
METHODS


A total 407 children aged 6 to 12 years with BMI ≥ 85th percentile receiving care at 2 health centers were randomly assigned to a healthy weight clinic (HWC) at the health center or to a modified Healthy Weight and Your Child (M-HWYC) intervention delivered in Young Men's Christian Associations. A total of 4037 children served as the comparison group. We completed a noninferiority test comparing the M-HWYC with the HWC, which was supported if the bounds of the 90% confidence interval (CI) for the difference in percentage of the 95th percentile (%BMIp 95 ) change did not contain what we considered a minimally clinically important difference, on the basis of previous data (0.87). Then, using linear mixed models, we assessed yearly changes in BMI among intervention participants compared with the comparison sites.
RESULTS


The mean difference in %BMIp 95  between the M-HWYC and the HWC was 0.75 (90% CI: 0.07 to 1.43), which did not support noninferiority. Compared with the comparison sites, per year, children in the HWC had a -0.23 (95% CI: -0.36 to -0.10) decrease in BMI and a -1.03 (95% CI -1.61 to -0.45) %BMIp 95  decrease. There was no BMI effect in the M-HWYC.
CONCLUSIONS


We were unable to establish noninferiority of the M-HWYC. The HWC improved BMI, offering an effective treatment of those disproportionately affected.",2021,"There was no BMI effect in the M-HWYC.
","['A total 407 children aged 6 to 12 years with BMI ≥ 85th percentile receiving care at 2 health centers', 'Healthy Weight', '4037 children served as the comparison group', ""2 pediatric weight management interventions delivered to Hispanic, low-income children (one in a health center the other in a Young Men's Christian Association""]",['healthy weight clinic (HWC) at the health center or to a modified Healthy Weight and Your Child (M-HWYC) intervention'],"['HWC improved BMI', 'BMI effect', 'BMI']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008532', 'cui_str': 'Christian religion'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",4037.0,0.0397836,"There was no BMI effect in the M-HWYC.
","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fiechtner', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children, Boston, Massachusetts lfiechtner@mgh.harvard.edu.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Perkins', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children, Boston, Massachusetts.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Biggs', 'Affiliation': 'Department of Pediatrics, Holyoke Community Health Center, Holyoke, Massachusetts.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Langhans', 'Affiliation': 'Department of Pediatrics, Greater New Bedford Community Health Center, New Bedford, Massachusetts.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Sharifi', 'Affiliation': 'Section of General Pediatrics, Department of Pediatrics, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Price', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children, Boston, Massachusetts.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children, Boston, Massachusetts.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Locascio', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Katherine H', 'Initials': 'KH', 'LastName': 'Hohman', 'Affiliation': ""Young Men's Christian Association of the United States of America, Chicago, Illinois.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hodge', 'Affiliation': ""Young Men's Christian Association of the United States of America, Chicago, Illinois.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Gortmaker', 'Affiliation': 'Departments of Social and Behavioral Sciences.'}, {'ForeName': 'Shioban', 'Initials': 'S', 'LastName': 'Torres', 'Affiliation': 'Bureau of Community Health and Prevention, Massachusetts Department of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Elsie M', 'Initials': 'EM', 'LastName': 'Taveras', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children, Boston, Massachusetts.'}]",Pediatrics,['10.1542/peds.2021-050405']
1485,34481342,"The effectiveness of Kinesio taping on playing-related pain, function and muscle strength in violin players: A randomized controlled clinical trial.","OBJECTIVES


This study aimed to investigate the effectiveness of Kinesio taping (KT) on playing-related pain, upper extremity and hand function, grip and pinch strength in violin players.
DESIGN


Randomized controlled trial.
SETTING


Faculty of health sciences.
PARTICIPANTS


One hundred seventeen participants who were professional violinists for at least two years (82 women; mean age, 22.76 ± 3.87 years) were randomized to receive either therapeutic tape application (KT group), a sham tape application (placebo group), or no application (control group) for one week.
OUTCOME MEASURES


The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) in one week. The secondary outcomes were the Visual Analogue Scale (VAS), the Purdue Pegboard Test, grip and pinch strength. Outcome measures were performed at baseline, immediately after the intervention, and one week later (follow-up). Participants were asked to play the ""Violin Concerto No.2, Op.35 (Rieding, Oskar)""; pre-and post-performance pain and grip and pinch strength were assessed.
RESULTS


The overall group-by-time interaction was not significant for DASH, but the improvement in the mean VAS-playing was slightly better in the KT group than in others (p < 0.05). The mean post-performance VAS-playing remained similar in the KT group while slightly increasing in the other groups (p < 0.05). In addition, a decrease in the mean post-performance grip strength of the left hand was significantly lower in the KT group than in the other groups (p < 0.05).
CONCLUSIONS


Violin players receiving an application of KT represented minor improvements in playing-related pain, and post-performance pain intensity and grip strength of the left hand slightly remained after 1 week kT application. The possible post-performance effect of the tape on the pain intensity and grip strength must also be considered because KT can be used during the performance.",2021,The mean post-performance VAS-playing remained similar in the KT group while slightly increasing in the other groups (p < 0.05).,"['violin players', 'One hundred seventeen participants who were professional violinists for at least two years (82 women; mean age, 22.76\xa0±\xa03.87 years', 'Faculty of health sciences']","['Kinesio taping (KT', 'Kinesio taping', 'therapeutic tape application (KT group), a sham tape application (placebo group), or no application (control group) for one week']","['mean post-performance VAS-playing', 'pain intensity and grip strength', 'Visual Analogue Scale (VAS), the Purdue Pegboard Test, grip and pinch strength', 'playing-related pain, upper extremity and hand function, grip and pinch strength', 'mean VAS-playing', 'playing-related pain, function and muscle strength', 'mean post-performance grip strength', 'Disabilities of the Arm, Shoulder and Hand (DASH', 'playing-related pain, and post-performance pain intensity and grip strength']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0204462', 'cui_str': 'Purdue pegboard test'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",117.0,0.052028,The mean post-performance VAS-playing remained similar in the KT group while slightly increasing in the other groups (p < 0.05).,"[{'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Topdemir', 'Affiliation': 'Istanbul Aydın University, Institute of Health Science, Turkey.'}, {'ForeName': 'Tansu', 'Initials': 'T', 'LastName': 'Birinci', 'Affiliation': 'Istanbul Medeniyet University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Turkey.'}, {'ForeName': 'Hanifegül', 'Initials': 'H', 'LastName': 'Taşkıran', 'Affiliation': 'Istanbul Aydın University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Turkey.'}, {'ForeName': 'Ebru Kaya', 'Initials': 'EK', 'LastName': 'Mutlu', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Turkey. Electronic address: fztebrukaya@hotmail.com.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.08.010']
1486,34490700,Degludec hospital trial: A randomized controlled trial comparing insulin degludec U100 and glargine U100 for the inpatient management of patients with type 2 diabetes.,"AIMS


Limited data exist about the use of insulin degludec in the hospital. This multicentre, non-inferiority, open-label, prospective randomized trial compared the safety and efficacy of insulin degludec-U100 and glargine-U100 for the management of hospitalized patients with type 2 diabetes.
METHODS


In total, 180 general medical and surgical patients with an admission blood glucose (BG) between 7.8 and 22.2 mmol/L, treated with oral agents or insulin before hospitalization were randomly allocated (1:1) to a basal-bolus regimen using degludec (n = 92) or glargine (n = 88), as basal and aspart before meals. Insulin dose was adjusted daily to a target BG between 3.9 and 10.0 mmol/L. The primary endpoint was the difference in mean hospital daily BG between groups.
RESULTS


Overall, the randomization BG was 12.2 ± 2.9 mmol/L and glycated haemoglobin 84 mmol/mol (9.8% ± 2.0%). There were no differences in mean daily BG (10.0 ± 2.1 vs. 10.0 ± 2.5 mmol/L, p = .9), proportion of BG in target range (54·5% ± 29% vs. 55·3% ± 28%, p = .85), basal insulin (29.6 ± 13 vs. 30.4 ± 18 units/day, p = .85), length of stay [median (IQR): 6.7 (4.7-10.5) vs. 7.5 (4.7-11.6) days, p = .61], hospital complications (23% vs. 23%, p = .95) between treatment groups. There were no differences in the proportion of patients with BG <3.9 mmol/L (17% vs. 19%, p = .75) or <3.0 mmol/L (3.7% vs. 1.3%, p = .62) between degludec and glargine.
CONCLUSION


Hospital treatment with degludec-U100 or glargine-U100 is equally safe and effective for the management of hyperglycaemia in general medical and surgical patients with type 2 diabetes.",2021,"CONCLUSION


Hospital treatment with degludec-U100 or glargine-U100 are equally safe and effective for the management of hyperglycaemia in general medicine and surgery patients with type 2 diabetes.","['surgery patients with type 2 diabetes', 'Patients with Type 2 Diabetes', 'hospitalized patients with type 2 diabetes', '180 general medicine and surgery patients with an admission blood glucose (BG) between 7·8 - 22·2\u2009mmol/L, treated with oral agents or insulin prior to hospitalization']","['insulin degludec-U100 and glargine-U100', 'Insulin Degludec U100 and Glargine U100', 'basal bolus regimen using degludec (n=92) or glargine']","['hospital complications', 'mean daily BG', 'mean hospital daily BG', 'length of stay']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",180.0,0.0452683,"CONCLUSION


Hospital treatment with degludec-U100 or glargine-U100 are equally safe and effective for the management of hyperglycaemia in general medicine and surgery patients with type 2 diabetes.","[{'ForeName': 'Rodolfo J', 'Initials': 'RJ', 'LastName': 'Galindo', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Radica', 'Initials': 'R', 'LastName': 'Alicic', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Lam', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Migdal', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Urrutia', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Citlalli', 'Initials': 'C', 'LastName': 'Perez-Guzman', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Karla Walkiria', 'Initials': 'KW', 'LastName': 'Zamudio-Coronado', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Biostatistics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Tuttle', 'Affiliation': 'Providence Health Care, Spokane, Washington, USA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.14544']
1487,34489516,"Nurse-led, telephone-based follow-up after acute coronary syndrome yields improved risk factors after 36 months: the randomized controlled NAILED-ACS trial.","We investigated whether a nurse-led, telephone-based follow-up including medical titration was superior to usual care in improving blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) values 36 months after acute coronary syndrome (ACS). We screened all patients admitted with ACS at Östersund hospital, Sweden, between January 1, 2010, and December 31, 2014, for inclusion based on ability to participate in a telephone-based follow-up. Participants were randomly allocated to usual care or an intervention group that received counselling and medical titration to target BP < 140/< 90 mmHg and LDL-C < 2.5/< 1.8 mmol/L. The primary outcome was LDL-C at 36 months. Of 962 patients, 797 (83%) were available for analysis after 36 months. Compared to controls, the intervention group had a mean systolic BP (SBP) 4.1 mmHg lower (95% confidence interval [CI] 1.9-6.5), mean diastolic BP (DBP) 2.9 mmHg lower (95% CI 1.5-4.5), and mean LDL-C 0.28 mmol/L lower (95% CI 0.135-0.42). All P < 0.001. A significantly greater proportion of patients reached treatment targets with the intervention. After 36 months of follow-up, compared to usual care, the nurse-led, telephone-based intervention led to significantly lower SBP, DBP, and LDL-C and to a larger proportion of patients meeting target values.Trial registration: ISRCTN registry. Trial number ISRCTN96595458. Retrospectively registered.",2021,"After 36 months of follow-up, compared to usual care, the nurse-led, telephone-based intervention led to significantly lower SBP, DBP, and LDL-C and to a larger proportion of patients meeting target values.","['patients admitted with ACS at Östersund hospital, Sweden, between January 1, 2010, and December 31, 2014, for inclusion based on ability to participate in a telephone-based follow-up', 'Of 962 patients, 797 (83%) were available for analysis after 36\xa0months']","['nurse-led, telephone-based follow-up including medical titration was superior to usual care', 'usual care or an intervention group that received counselling and medical titration to target BP\u2009<\u2009140/<\u200990\xa0mmHg and LDL-C\u2009']","['LDL-C', 'blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C', 'SBP, DBP, and LDL-C', 'mean diastolic BP', 'mean systolic BP (SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.059467,"After 36 months of follow-up, compared to usual care, the nurse-led, telephone-based intervention led to significantly lower SBP, DBP, and LDL-C and to a larger proportion of patients meeting target values.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Henriksson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Östersund, Umeå, Sweden. Robin.henriksson@regionjh.se.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Huber', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Östersund, Umeå, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mooe', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Östersund, Umeå, Sweden.'}]",Scientific reports,['10.1038/s41598-021-97239-x']
1488,34491885,Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome: : A Randomized Pilot Study.,,2021,,['COVID-19-induced Acute Respiratory Distress Syndrome: '],[],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]",[],[],,0.0188119,,"[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Page', 'Affiliation': 'The University of Alabama at Birmingham School of Medicine, 9967, Emergency Medicine , Birmingham, Alabama, United States.'}, {'ForeName': 'Kadambari', 'Initials': 'K', 'LastName': 'Vijaykumar', 'Affiliation': 'The University of Alabama at Birmingham School of Medicine, 9967, Medicine; Division of Pulmonary, Allergy and Critical Care Medicine, Birmingham, Alabama, United States.'}, {'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Russell', 'Affiliation': 'The University of Alabama at Birmingham School of Medicine, 9967, Medicine; Division of Pulmonary, Allergy and Critical Care Medicine, Birmingham, Alabama, United States.'}, {'ForeName': 'Sheetal', 'Initials': 'S', 'LastName': 'Gandotra', 'Affiliation': 'The University of Alabama at Birmingham School of Medicine, 9967, Medicine; Division of Pulmonary, Allergy and Critical Care Medicine, Birmingham, Alabama, United States.'}, {'ForeName': 'Joe W', 'Initials': 'JW', 'LastName': 'Chiles', 'Affiliation': 'The University of Alabama at Birmingham School of Medicine, 9967, Medicine; Division of Pulmonary, Allergy and Critical Care Medicine, Birmingham, Alabama, United States.'}, {'ForeName': 'Micah R', 'Initials': 'MR', 'LastName': 'Whitson', 'Affiliation': 'The University of Alabama at Birmingham School of Medicine, 9967, Medicine; Division of Pulmonary, Allergy and Critical Care Medicine, Birmingham, Alabama, United States.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'The University of Alabama at Birmingham School of Medicine, 9967, Medicine; Division of Pulmonary, Allergy and Critical Care Medicine, Birmingham, Alabama, United States.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202104-498RL']
1489,34491840,Prevention of Choroidal Thinning by 0.01% Atropine Administered 24 h Before Exposure to Hyperopic Blur in Young Myopes.,"Purpose:  To evaluate the persistence of atropine's effect upon choroidal thickness and ocular biometrics and its interaction with hyperopic blur in a population of young adult myopes.  Methods:  Twenty young (aged 18-35 years) myopic participants with spherical equivalent refractive error of -0.75 to -6.00 D (mean ± SD -2.85 ± 1.64 D) had subfoveal choroidal thickness (SFCT) measurements derived from scans collected from the right eye only with a SD-OCT instrument (Copernicus SOCT-HR) before, as well as 60 min following the introduction of 3 testing conditions: (1) placebo/hyperopic (-3 D) blur, (2) placebo/hyperopic blur one day after administration of 0.01% atropine, and (3) placebo/no blur. Each combination of blur and pharmacological agent was tested on a separate day at approximately the same time of day between 9 am and 2 pm.  Results:  Repeated measures ANOVA revealed that hyperopic blur and placebo were associated  with  a decrease in choroidal thickness (mean change: -10.7 ± 2.7 μm,  P  < 0.001 after 60 min), whereas administration of 0.01% atropine one day before the introduction of hyperopic blur prevented the thinning of the choroid (mean change of +1.1 ± 3.7 μm after 60 min) compared to baseline (both,  P  > 0.05). There was also no significant difference between the baseline choroidal thickness measurements for any of the conditions tested.  Conclusion:  Low dose atropine can inhibit signals associated with hyperopic defocus that cause thinning of the choroid for at least 24 h after initial instillation .",2021,There was also no significant difference between the baseline choroidal thickness measurements for any of the conditions tested.  ,"['Young Myopes', 'Twenty young (aged 18-35 years) myopic participants with spherical equivalent refractive error of -0.75 to -6.00']","['atropine', 'placebo/hyperopic blur one day after administration of 0.01% atropine, and (3) placebo/no blur', 'Atropine', ""atropine's""]","['choroidal thickness', 'subfoveal choroidal thickness (SFCT) measurements', 'baseline choroidal thickness measurements']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4517393', 'cui_str': '0.01'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.460161,There was also no significant difference between the baseline choroidal thickness measurements for any of the conditions tested.  ,"[{'ForeName': 'Beata P', 'Initials': 'BP', 'LastName': 'Sander', 'Affiliation': 'Contact Lens and Visual Optics Laboratory, School of Optometry and Vision Science, Queensland University of Technology, Brisbane, Australia.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2021.0006']
1490,34494280,Comparison of outcomes between neoadjuvant imatinib and upfront surgery in patients with localized rectal GIST: An inverse probability of treatment weighting analysis.,"BACKGROUND AND OBJECTIVES


This study aimed to compare outcomes between neoadjuvant imatinib and upfront surgery in patients with localized rectal gastrointestinal stromal tumors (GIST) patients.
METHODS


Eighty-five patients with localized rectal GIST were divided into two groups: upfront surgery ± adjuvant imatinib (Group A, n = 33) and the neoadjuvant imatinib + surgery + adjuvant imatinib (Group B, n = 52). Baseline characteristics between groups were controlled for with inverse probability of treatment weighting (IPTW) adjusted analysis.
RESULTS


The response rate to neoadjuvant imatinib was 65.9%. After the IPTW-adjusted analysis, patients who underwent neoadjuvant therapy had better distant recurrence-free survival (DRFS) and disease-specific survival (DSS) compared with those who underwent upfront surgery (5-year DRFS 97.8 vs. 71.9%, hazard ratio [HR], 0.15; 95% CI, 0.03-0.87; p = 0.03; 5-year DSS 100 vs. 77.1%; HR, 0.11; 95% CI, 0.01-0.92; p = 0.04). While no significant association was found between overall survival (OS) and treatment groups (p = 0.07), 5-year OS was higher for the neoadjuvant group than upfront surgery group (97.8% vs. 71.9%; HR, 0.2; 95% CI, 0.03-1.15).
CONCLUSIONS


In patients with localized rectal GIST, neoadjuvant imatinib not only shrunk the tumor size but also decreased the risk of metastasis and tumor-related deaths when compared to upfront surgery and adjuvant imatinib alone.",2021,"While no significant association was found between overall survival (OS) and treatment groups (p = 0.07), 5-year OS was higher for the neoadjuvant group than upfront surgery group (97.8% vs. 71.9%; HR, 0.2; 95% CI, 0.03-1.15).
","['patients with localized rectal GIST', 'patients with localized rectal gastrointestinal stromal tumors (GIST) patients', 'Eighty-five patients with localized rectal GIST']","['neoadjuvant imatinib\u2009+\u2009surgery\u2009+\u2009adjuvant imatinib', 'upfront surgery\u2009±\u2009adjuvant imatinib', 'neoadjuvant imatinib and upfront surgery']","['overall survival (OS', 'distant recurrence-free survival (DRFS) and disease-specific survival (DSS', 'risk of metastasis and tumor-related deaths', '5-year OS', 'response rate to neoadjuvant imatinib']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C4517892', 'cui_str': '85'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]",85.0,0.174504,"While no significant association was found between overall survival (OS) and treatment groups (p = 0.07), 5-year OS was higher for the neoadjuvant group than upfront surgery group (97.8% vs. 71.9%; HR, 0.2; 95% CI, 0.03-1.15).
","[{'ForeName': 'Jia-Yu', 'Initials': 'JY', 'LastName': 'Ling', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Miao-Miao', 'Initials': 'MM', 'LastName': 'Ding', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zi-Feng', 'Initials': 'ZF', 'LastName': 'Yang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, China.'}, {'ForeName': 'Yan-Dong', 'Initials': 'YD', 'LastName': 'Zhao', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, China.'}, {'ForeName': 'Xiao-Yu', 'Initials': 'XY', 'LastName': 'Xie', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Li-Shuo', 'Initials': 'LS', 'LastName': 'Shi', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, China.'}, {'ForeName': 'Huai-Ming', 'Initials': 'HM', 'LastName': 'Wang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, China.'}, {'ForeName': 'Wu-Teng', 'Initials': 'WT', 'LastName': 'Cao', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hua-Bin', 'Initials': 'HB', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, China.'}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}]",Journal of surgical oncology,['10.1002/jso.26664']
1491,34493827,Impact of exogenous estradiol on task-based and resting-state neural signature during and after fear extinction in healthy women.,"Fluctuations of endogenous estrogen modulates fear extinction, but the influence of exogenous estradiol is less studied. Moreover, little focus has been placed on the impact of estradiol on broad network connectivity beyond the fear extinction circuit. Here, we examined the effect of acute exogenous estradiol administration on fear extinction-induced brain activation, whole-brain functional connectivity (FC) during the fear extinction task and post-extinction resting-state. Ninety healthy women (57 using oral contraceptives [OC], 33 naturally cycling [NC]) were fear conditioned on day 1. They ingested an estradiol or placebo pill prior to extinction learning on day 2 (double-blind design). Extinction memory was assessed on day 3. Task-based functional MRI data were ascertained on days 2 and 3 and resting-state data were collected post-extinction on day 2 and pre-recall on day 3. Estradiol administration significantly modulated the neural signature associated with fear extinction learning and memory, consistent with prior studies. Importantly, estradiol administration induced significant changes in FC within multiple networks, including the default mode and somatomotor networks during extinction learning, post-extinction, and during extinction memory recall. Exploratory analyses revealed that estradiol impacted ventromedial prefrontal cortex (vmPFC) activation and FC differently in the NC and OC women. The data implicate a more diffused and significant effect of acute estradiol administration on multiple networks. Such an effect might be beneficial to modulating attention and conscious processes in addition to engaging neural processes associated with emotional learning and memory consolidation.",2021,"Importantly, estradiol administration induced significant changes in FC within multiple networks, including the default mode and somatomotor networks during extinction learning, post-extinction, and during extinction memory recall.","['healthy women', 'Ninety healthy women (57 using oral contraceptives [OC], 33 naturally cycling [NC']","['Estradiol', 'estradiol or placebo pill prior to extinction learning', 'acute exogenous estradiol', 'exogenous estradiol']","['estradiol impacted ventromedial prefrontal cortex (vmPFC) activation and FC', 'fear extinction-induced brain activation, whole-brain functional connectivity (FC', 'Extinction memory', 'FC within multiple networks, including the default mode and somatomotor networks during extinction learning, post-extinction, and during extinction memory recall']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0679063', 'cui_str': 'Memory recall'}]",90.0,0.0725527,"Importantly, estradiol administration induced significant changes in FC within multiple networks, including the default mode and somatomotor networks during extinction learning, post-extinction, and during extinction memory recall.","[{'ForeName': 'Zhenfu', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Mira Z', 'Initials': 'MZ', 'LastName': 'Hammoud', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'J Cobb', 'Initials': 'JC', 'LastName': 'Scott', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jagan', 'Initials': 'J', 'LastName': 'Jimmy', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Marin', 'Affiliation': 'Departement of Psychology, Université du Québec à Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Asnaani', 'Affiliation': 'Department of Psychology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mohammed R', 'Initials': 'MR', 'LastName': 'Milad', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, NY, USA. Mohammed.Milad@nyulangone.org.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01158-4']
1492,34497023,Randomized controlled trial on the performance of direct and indirect composite restorations in patients with severe tooth wear.,"OBJECTIVE


The study aimed to evaluate survival and failure behavior of Direct Composite Restorations (DRC) and Indirect Composite Restorations (ICR) on molars and anterior teeth, in a Randomized Controlled Trial (RCT).
METHODS


Patients with generalized severe tooth wear were included, and randomly assigned to one of 2 protocols: (1) DCR: All teeth were restored with directly applied micro-hybrid composite restorations (Clearfil AP-X, Kuraray) for load bearing areas and nano-hybrid composite restorations (IPS Empress Direct, Ivoclar Vivadent) for buccal veneers; (2) ICR: First molars were restored with indirect composite 'tabletop' restorations and maxillary anterior teeth were restored with indirect palatal veneer restorations (Clearfil Estenia C&B, cemented with Panavia F, Kuraray). Remaining teeth were restored directly. Restorations were evaluated after 3 years, focusing on clinical acceptability. Statistical analysis was performed using Kaplan Meier curves, Annual Failure Rates (AFRs), and univariate Cox regression analyses (p < 0.05).
RESULTS


41 patients (age: 36.6 ± 6.6y) were evaluated after 3 years (40.0 ± 2.2 m). 408 restorations on first molars and palatal veneers on maxillary anterior teeth were part of this RCT, with 220 DCRs and 188 ICRs. No differences in survival between treatment modality for palatal veneers for any failure criteria were found. Tabletop restorations on first molars showed a considerable higher failure rate for ICR compared to DCR (p = 0.026, HR: 3.37, 95%CI = 1.16-9.81).
SIGNIFICANCE


In this RCT, directly applied composite restorations showed superior behavior compared to the indirect composite restorations, when used in the molar region.",2021,"Tabletop restorations on first molars showed a considerable higher failure rate for ICR compared to DCR (p = 0.026, HR: 3.37, 95%CI = 1.16-9.81).
","['41 patients (age: 36.6 ± 6.6y) were evaluated after 3 years (40.0 ± 2.2 m', 'patients with severe tooth wear', 'molars and anterior teeth', '408 restorations on first molars and palatal veneers on maxillary anterior teeth were part of this RCT, with 220 DCRs and 188 ICRs', 'Patients with generalized severe tooth wear']","['Direct Composite Restorations (DRC) and Indirect Composite Restorations (ICR', 'direct and indirect composite restorations', 'DCR', ""indirect composite 'tabletop' restorations and maxillary anterior teeth were restored with indirect palatal veneer restorations (Clearfil Estenia C&B, cemented with Panavia F, Kuraray""]","['Kaplan Meier curves, Annual Failure Rates (AFRs), and univariate Cox regression analyses', 'failure rate', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0559953', 'cui_str': 'Veneer'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0025925', 'cui_str': 'Mouse, Inbred ICR'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0559953', 'cui_str': 'Veneer'}, {'cui': 'C1138154', 'cui_str': 'Estenia'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C1098778', 'cui_str': 'Panavia-Fluoro'}]","[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0034980', 'cui_str': 'Analysis, Regression'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",408.0,0.0799292,"Tabletop restorations on first molars showed a considerable higher failure rate for ICR compared to DCR (p = 0.026, HR: 3.37, 95%CI = 1.16-9.81).
","[{'ForeName': 'L A M J', 'Initials': 'LAMJ', 'LastName': 'Crins', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Dentistry, The Netherlands. Electronic address: Luuk.Crins@radboudumc.nl.'}, {'ForeName': 'N J M', 'Initials': 'NJM', 'LastName': 'Opdam', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Dentistry, The Netherlands.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Kreulen', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Dentistry, The Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Bronkhorst', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Dentistry, The Netherlands.'}, {'ForeName': 'B A M M', 'Initials': 'BAMM', 'LastName': 'Sterenborg', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Dentistry, The Netherlands.'}, {'ForeName': 'M C D N J M', 'Initials': 'MCDNJM', 'LastName': 'Huysmans', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Dentistry, The Netherlands.'}, {'ForeName': 'B A C', 'Initials': 'BAC', 'LastName': 'Loomans', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Dentistry, The Netherlands.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2021.08.018']
1493,34496357,Bursted auricular vagus nerve stimulation alters heart rate variability in healthy subjects.,"Objective. Recent research suggests that percutaneous auricular vagus nerve stimulation (pVNS) beneficially modulates the autonomic nervous system (ANS). Bursted pVNS seems to be efficient for nerve excitation. Bursted pVNS effects on cardiac autonomic modulation are not disclosed yet. Approach. For the first time, the present study evaluates the effect of pVNS on cardiac autonomic modulation in healthy subjects ( n  = 9) using two distinct bursted stimulation patterns (biphasic and triphasic stimulation) and heart rate variability analysis (HRV). Stimulation was delivered via four needle electrodes in vagally innervated regions of the right auricle. Each of the two bursted stimulation patterns was applied twice in randomized order over four consecutive stimulation sessions per subject. Main results. Bursted pVNS did not change heart rate, blood pressure, and inflammatory parameters in study subjects. pVNS significantly increased the standard deviation of heart inter-beat intervals, from 46.39 ± 10.4 ms to 63.46 ± 22.47 ms ( p  < 0.05), and the total power of HRV, from 1475.7 ± 616.13 ms 2 to 3190.5 ± 2037.0 ms 2 ( p  < 0.05). The high frequency ( HF ) power, the low frequency ( LF ) power, and the LF/HF ratio did not change during bursted pVNS. Both stimulation patterns did not show any significant differences in cardiac autonomic modulation. Stimulation intensity to reach a tingling sensation was significantly lower in triphasic compared to biphasic stimulation ( p < 0.05). Bursted stimulation was well tolerated. Significance. Bursted pVNS seems to affect cardiac autonomic modulation in healthy subjects, with no difference between biphasic and triphasic stimulation, the latter requiring lower stimulation intensities. These findings foster implementation of more efficient pVNS stimulation.",2021,Stimulation intensity to reach a tingling sensation was significantly lower in triphasic compared to biphasic stimulation (p<0.05).,"['healthy subjects (n=9) using two distinct bursted stimulation patterns (biphasic and triphasic stimulation) and heart rate variability analysis (HRV', 'healthy subjects']","['Bursted auricular vagus nerve stimulation', 'pVNS', 'percutaneous auricular vagus nerve stimulation (pVNS']","['total power of HRV', 'standard deviation of heart inter-beat intervals', 'tolerated', 'high frequency (HF) power, the low frequency (LF) power, and the LF/HF ratio', 'change heart rate, blood pressure, and inflammatory parameters', 'cardiac autonomic modulation', 'Stimulation intensity to reach a tingling sensation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0205185', 'cui_str': 'Triphasic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C2242996', 'cui_str': 'Has tingling sensation'}]",,0.015955,Stimulation intensity to reach a tingling sensation was significantly lower in triphasic compared to biphasic stimulation (p<0.05).,"[{'ForeName': 'Jozsef C', 'Initials': 'JC', 'LastName': 'Széles', 'Affiliation': 'Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kampusch', 'Affiliation': 'SzeleSTIM GmbH, Vienna, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Thürk', 'Affiliation': 'Institute of Electrodynamics, Microwave and Circuit Engineering, TU Wien, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Clodi', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Fichtenbauer', 'Affiliation': 'Institute of Electrodynamics, Microwave and Circuit Engineering, TU Wien, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schwanzer', 'Affiliation': 'Institute of Electrodynamics, Microwave and Circuit Engineering, TU Wien, Vienna, Austria.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schwarzenberger', 'Affiliation': 'Institute of Electrodynamics, Microwave and Circuit Engineering, TU Wien, Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Neumayer', 'Affiliation': 'Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Eugenijus', 'Initials': 'E', 'LastName': 'Kaniusas', 'Affiliation': 'Institute of Electrodynamics, Microwave and Circuit Engineering, TU Wien, Vienna, Austria.'}]",Physiological measurement,['10.1088/1361-6579/ac24e6']
1494,32476624,"""I Quit"": Testing the Added Value and Sequencing Effects of an Efficacy-focused Message among Cigarette Warning Labels.","Many emotional appeal theorists argue that negative affect and efficacy work together to promote adaptive behavioral responses to a threat, yet most research on cigarette warning label messages has not examined the intersection between negative affect, hope, and efficacy. The current study tests effects of exposure, at different points in a sequence, to an efficacy-focused warning label in the context of threat-focused warning labels. We conducted an online, between- and within-subjects experiment with 398 adult smokers, testing the effects of warning label exposure on negative affect, hope, efficacy beliefs, and intentions to quit. Exposure to the efficacy-focused ""Quit"" label aroused higher levels of reported hope and lower levels of reported negative affect than threat-focused labels. Negative affect increased with each additional exposure to a threat-focused warning label, regardless of the order in which respondents saw the ""Quit"" label. Exposure to the ""Quit"" label (within a larger set of three threat-focused labels) led to greater self-efficacy but did not influence response efficacy or intentions to quit. We conclude that ""Quit"" messaging on warning labels can inspire both hopeful feelings and efficacy beliefs. Future research should identify the optimal balance between threat-focused and hopeful quit messages.",2020,"Negative affect increased with each additional exposure to a threat-focused warning label, regardless of the order in which respondents saw the ""Quit"" label.",['398 adult smokers'],"['I Quit', 'Quit"" messaging', 'Quit"" label']","['efficacy beliefs, and intentions to quit']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",398.0,0.0197348,"Negative affect increased with each additional exposure to a threat-focused warning label, regardless of the order in which respondents saw the ""Quit"" label.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Jesch', 'Affiliation': 'Department of Communication, Cornell University , Ithaca, NY, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Niederdeppe', 'Affiliation': 'Department of Communication, Cornell University , Ithaca, NY, USA.'}, {'ForeName': 'Andy J', 'Initials': 'AJ', 'LastName': 'King', 'Affiliation': 'Greenlee School Journalism and Communication, Iowa State University , Ames, IA, USA.'}, {'ForeName': 'Amelia Greiner', 'Initials': 'AG', 'LastName': 'Safi', 'Affiliation': 'Department of Communication, Cornell University , Ithaca, NY, USA.'}, {'ForeName': 'Sahara', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Department of Communication, Cornell University , Ithaca, NY, USA.'}]",Journal of health communication,['10.1080/10810730.2020.1767236']
1495,34499570,Toward a Just-in-Time Adaptive Intervention to Reduce Emerging Adult Alcohol Use: Testing Approaches for Identifying When to Intervene.,"ABBREVIATIONS


JITAI: Just-in-time adaptive intervention; ROC: receiver operating characteristic; AUC: area under the curve; MRT: micro-randomized trial.",2021,"ABBREVIATIONS


JITAI: Just-in-time adaptive intervention; ROC: receiver operating characteristic; AUC: area under the curve; MRT: micro-randomized trial.",['Emerging Adult Alcohol Use'],[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",[],[],,0.0894484,"ABBREVIATIONS


JITAI: Just-in-time adaptive intervention; ROC: receiver operating characteristic; AUC: area under the curve; MRT: micro-randomized trial.","[{'ForeName': 'Lara N', 'Initials': 'LN', 'LastName': 'Coughlin', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Philyaw-Kotov', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Mashfiqui', 'Initials': 'M', 'LastName': 'Rabbi', 'Affiliation': 'Department of Statistics, Harvard University, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Klasnja', 'Affiliation': 'School of Information, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}]",Substance use & misuse,['10.1080/10826084.2021.1972314']
1496,34505215,Assessing the Effects of a Real-Life Contact Intervention on Prejudice Toward LGBT People.,"Prejudice against sexual and gender minorities (e.g., LGBT people) is quite prevalent and is harmful. We examined an existing-and often-used-contact intervention in pre-existing groups in an educational setting and assessed its effectiveness in reducing different forms of LGBT negativity. We focused particularly on modern LGBT negativity: a relatively subtle form of prejudice, involving ambivalence, denial, and/or the belief that there is too much attention for LGBT prejudice. We used a mixed design in which condition (experimental vs. control group) was the between-participants factor, which was randomized at the group level, and time (pretest vs. posttest vs. follow-up) was the within-participants factor (N = 117). Interventions were video recorded and the behavior of LGBT educators and participants was coded. Participants responded positively to the intervention, especially to the LGBT educator's ""coming-out story."" Exploratory analysis of the video data indicated that the perceived effectiveness of the intervention was higher in groups where participants were more engaged, although caution is necessary in interpreting this finding. The most important measure indicated that modern LGBT negativity decreased in the intervention groups directly after the intervention, but returned to baseline levels one week later. However, in the control condition, modern LGBT negativity had increased over time. Taken together, this suggests that an actual reduction in modern LGBT negativity was short-lived (i.e., the intervention effect disappeared within 7 days).",2021,"Exploratory analysis of the video data indicated that the perceived effectiveness of the intervention was higher in groups where participants were more engaged, although caution is necessary in interpreting this finding.",['Prejudice Toward LGBT People'],['Real-Life Contact Intervention'],['modern LGBT negativity'],"[{'cui': 'C0033023', 'cui_str': 'Prejudice'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.016557,"Exploratory analysis of the video data indicated that the perceived effectiveness of the intervention was higher in groups where participants were more engaged, although caution is necessary in interpreting this finding.","[{'ForeName': 'Florien M', 'Initials': 'FM', 'LastName': 'Cramwinckel', 'Affiliation': 'Department of Interdisciplinary Social Science: Youth Studies, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Daan T', 'Initials': 'DT', 'LastName': 'Scheepers', 'Affiliation': 'Social, Economic and Organizational Psychology, Leiden University, Wassenaarseweg 52, 2333 AK, Leiden, The Netherlands. scheepersdt@fsw.leidenuniv.nl.'}, {'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Wilderjans', 'Affiliation': 'Methodology and Statistics Unit, Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Robert-Jan B', 'Initials': 'RB', 'LastName': 'de Rooij', 'Affiliation': 'Social, Economic and Organizational Psychology, Leiden University, Wassenaarseweg 52, 2333 AK, Leiden, The Netherlands.'}]",Archives of sexual behavior,['10.1007/s10508-021-02046-0']
1497,34506630,The effect of 1-year mean step count on the change in the atherosclerotic cardiovascular disease risk calculation in patients with high cardiovascular risk: a sub-study of the LIGHT randomized clinical trial.,,2021,,['patients with high cardiovascular risk'],[],['ASCVD risk calculation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}]",,0.162889,,"[{'ForeName': 'Mert İlker', 'Initials': 'Mİ', 'LastName': 'Hayıroğlu', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey. mertilkerh@yahoo.com.'}, {'ForeName': 'Tufan', 'Initials': 'T', 'LastName': 'Çınar', 'Affiliation': 'Department of Cardiology, Haydarpasa Sultan II. Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Göksel', 'Initials': 'G', 'LastName': 'Çinier', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Karakaya', 'Affiliation': 'Department of Cardiology, Haydarpasa Sultan II. Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Muhammet', 'Initials': 'M', 'LastName': 'Yıldırım', 'Affiliation': 'Department of Cardiology, Haydarpasa Sultan II. Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Başak Çakır', 'Initials': 'BÇ', 'LastName': 'Güney', 'Affiliation': 'Department of Cardiology, Haydarpasa Sultan II. Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Öz', 'Affiliation': 'Department of Cardiology, Haydarpasa Sultan II. Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Pınar Demir', 'Initials': 'PD', 'LastName': 'Gündoğmuş', 'Affiliation': 'Department of Cardiology, Haydarpasa Sultan II. Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Altuğ', 'Initials': 'A', 'LastName': 'Ösken', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Asibe', 'Initials': 'A', 'LastName': 'Özkan', 'Affiliation': 'Department of Medical Nursing, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Karabağ', 'Affiliation': 'Department of Cardiology, Kafkas University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Selin Cilli', 'Initials': 'SC', 'LastName': 'Hayıroğlu', 'Affiliation': 'Department of Rheumatology, Marmara University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kaplan', 'Affiliation': 'Department of Cardiology, Haydarpasa Sultan II. Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Altundaş', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ahmet İlker', 'Initials': 'Aİ', 'LastName': 'Tekkeşin', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}]",Kardiologia polska,['10.33963/KP.a2021.0108']
1498,34506343,Out-of-Facility Multimonth Dispensing of Antiretroviral Treatment: A Pooled Analysis Using Individual Patient Data From Cluster-Randomized Trials in Southern Africa.,"BACKGROUND


Out-of-facility multi-month dispensing (MMD) is a differentiated service delivery model which provides antiretroviral treatment (ART) at intervals of up to 6 monthly in the community. Limited randomized evidence investigating out-of-facility MMD is available. We evaluated participant outcomes and compared out-of-facility MMD models using data from cluster-randomized trials in Southern Africa.
SETTING


Eight districts in Zimbabwe and Lesotho.
METHODS


Individual-level participant data from 2 cluster-randomized trials that included stable adults receiving ART at 60 facilities were pooled. Both trials had 3 arms: ART collected 3-monthly at healthcare facilities (3MF, control); ART provided three-monthly in community ART groups (CAGs) (3MC); and ART provided 6-monthly in either CAGs or on an individual provider-patient basis (6MC). Participant retention, viral suppression and incidence of unscheduled facility visits were compared.
RESULTS


Ten thousand one hundred thirty-six participants were included, 3817 (37.7%), 2893 (28.5%) and 3426 (33.8%) in arms 3MF, 3MC and 6MC, respectively. After 12 months, retention was non-inferior for 3MC (95.7%) vs. 3MF (95.0%) {adjusted risk difference (aRD) = 0.3 [95% confidence interval (CI): -0.8 to 1.4]}; and 6MC (95.1%) vs. 3MF [aRD = -0.2 (95% CI: -1.4 to 1.0)]. Retention was greater amongst intervention arm participants in CAGs versus 6MC participants not in CAGs, aRD = 1.5% (95% CI: 0.2% to 2.9%). Viral suppression was excellent (≥98%) and unscheduled facility visits were not increased in the intervention arms.
CONCLUSIONS


Three and 6-monthly out-of-facility MMD was non-inferior versus facility-based care for stable ART patients. Out-of-facility 6-monthly MMD should incorporate small group peer support whenever possible.
CLINICALTRIAL REGISTRATION


ClinicalTrials.gov NCT03238846 and NCT03438370.",2021,"Retention was greater amongst intervention arm participants in CAGs versus 6MC participants not in CAGs, aRD= 1.5% (95% CI: 0.2% to 2.9%).","['10,136 participants were included, 3817 (37.7%), 2893 (28.5%) and 3426 (33.8%) in arms 3MF, 3MC and 6MC, respectively', 'Eight districts in Zimbabwe and Lesotho', 'Southern Africa', 'Individual-level participant data from two cluster-randomized trials that included stable adults receiving ART at 60 facilities were pooled']",['Antiretroviral Treatment'],"['unscheduled facility visits', 'Retention', 'Participant retention, viral suppression (VS) and incidence of unscheduled facility visits']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C0001746', 'cui_str': 'Southern Africa'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",10136.0,0.422737,"Retention was greater amongst intervention arm participants in CAGs versus 6MC participants not in CAGs, aRD= 1.5% (95% CI: 0.2% to 2.9%).","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lopes', 'Affiliation': 'Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Grimwood', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa.""}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Ngorima-Mabhena', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa.""}, {'ForeName': 'Appolinaire', 'Initials': 'A', 'LastName': 'Tiam', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Washington DC, United States.'}, {'ForeName': 'Betty Bawuba', 'Initials': 'BB', 'LastName': 'Tukei', 'Affiliation': 'Right to Care/EQUIP Health, Maseru, Lesotho.'}, {'ForeName': 'Tonderai', 'Initials': 'T', 'LastName': 'Kasu', 'Affiliation': 'Ministry of Health and Child Care, Zimbabwe.'}, {'ForeName': 'Nyika', 'Initials': 'N', 'LastName': 'Mahachi', 'Affiliation': 'Zimbabwe College of Public Health Physicians, Harare, Zimbabwe.'}, {'ForeName': 'Eula', 'Initials': 'E', 'LastName': 'Mothibi', 'Affiliation': 'Right to Care/EQUIP Health, Centurion, South Africa.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Tukei', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Maseru, Lesotho.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chasela', 'Affiliation': 'Right to Care/EQUIP Health, Centurion, South Africa.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Fatti', 'Affiliation': 'Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002797']
1499,34507338,Pilot Testing of a Nurse-Led Basic Symptom Self-management Support for Patients Receiving First-Line Systemic Outpatient Anticancer Treatment: A Cluster-Randomized Study (Symptom Navi Pilot Study).,"BACKGROUND


The Symptom Navi Program (SNP) is a nurse-led intervention supporting basic symptom self-management for patients with any cancer diagnosis. The SNP has been accepted by patients and healthcare professionals alike.
OBJECTIVE


The aims of this study were to pilot the SNP and evaluate patient-reported symptom outcomes, nursing support for symptom management, and patient safety.
METHODS


Using a cluster-randomized design, we randomized centers to the intervention (SNP) or control group (usual care). Adult patients starting first-line systemic cancer treatment were included. The primary outcome was the change in symptom interference with daily functions from treatment onset to 16 weeks. Secondary outcomes included changes in symptom severity, symptom burden, self-efficacy, and perceived symptom management support and patient safety. We used linear and logistic mixed-effects models to pilot-test differences in mean changes between groups. The trial was registered with ClinicalTrials.gov (NCT03649984).
RESULTS


Changes in symptom interference with daily functions did not differ (mean difference at 16 weeks: -0.50; 95% confidence interval, -1.38 to 0.38; P = 0.25) between SNP (3 centers, 49 patients) and control (5 centers, 85 patients) as for all other outcomes. No adverse events were reported.
CONCLUSIONS


Our preliminary findings did not indicate an effect of the SNP on patient-reported symptom outcomes, self-efficacy, or symptom management support. Inadequate power and SNP components (eg, insufficient training, low number of follow-up consultations) may be attributed to the lack of an observed effect.
IMPLICATIONS FOR PRACTICE


The SNP training content and intervention procedures merit reconsideration.",2021,"RESULTS


Changes in symptom interference with daily functions did not differ (mean difference at 16 weeks:","['patients with any cancer diagnosis', 'Adult patients starting first-line systemic cancer treatment were included', 'Patients Receiving First-Line Systemic Outpatient Anticancer Treatment']","['intervention (SNP) or control group (usual care', 'Symptom Navi Program (SNP', 'Nurse-Led Basic Symptom Self-management Support']","['adverse events', 'changes in symptom severity, symptom burden, self-efficacy, and perceived symptom management support and patient safety', 'change in symptom interference with daily functions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0997267,"RESULTS


Changes in symptom interference with daily functions did not differ (mean difference at 16 weeks:","[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Bana', 'Affiliation': 'Author affiliations: School of Health Sciences, University of Applied Sciences and Arts Western Switzerland-Fribourg (Dr Bana); Institute of Higher Education and Research in Health Care IUFRS, University of Lausanne and Lausanne University Hospital, Faculty of Biology and Medicine (Drs Bana, Ribi, and Eicher); International Breast Cancer Study Group (Dr Ribi); Hospital Group Lindenhof, Bern (Mmes Kropf-Staub and Zürcher-Florin); Department of Practice Development in Nursing, Solothurner Spitäler (Mr Näf); Departement Onkologie/Hämatologie Kantonsspital Graubünden, Chur (Mrs Stoffel); Gynäkologisches Tumorzentrum, Universitätsspital Basel (Dr Bläuer); Brustzentrum Bern, Oncocare (Dr Borner); rundum Onkologie am Bahnhofplatz, Sargans (Mrs Malin); Tumorzentrum ZeTuP Rapperswil-Jona (Mrs Biber); freiburger spital HFR (Dr Betticher); Onkologie- und Hämatologiezentrum Thun-Berner Oberland (Mrs Kuhn-Bächler); Division Onkologie, Hämatologie und Transfusionsmedizin, Kantonsspital Aarau (Dr Cantoni and Mr Seeger); Universität Bern, CTU (Dr Butikofer); and Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne (Drs Peters and Eicher), Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ribi', 'Affiliation': ''}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Kropf-Staub', 'Affiliation': ''}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Näf', 'Affiliation': ''}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Zürcher-Florin', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stoffel', 'Affiliation': ''}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Blaeuer', 'Affiliation': ''}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Borner', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Malin', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Biber', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Betticher', 'Affiliation': ''}, {'ForeName': 'Trudy', 'Initials': 'T', 'LastName': 'Kuhn-Bächler', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cantoni', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seeger', 'Affiliation': ''}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Bütikofer', 'Affiliation': ''}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Eicher', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000995']
1500,34449185,Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk.,"BACKGROUND


The appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear.
METHODS


One month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least 2 additional months (standard therapy). The three ranked primary outcomes were net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences were assessed at 335 days. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population.
RESULTS


Among the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, -0.23 percentage points; 95% confidence interval [CI], -1.80 to 1.33; P<0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P = 0.001 for noninferiority). Among the 4579 patients in the intention-to-treat population, major or clinically relevant nonmajor bleeding occurred in 148 patients (6.5%) in the abbreviated-therapy group and in 211 (9.4%) in the standard-therapy group (difference, -2.82 percentage points; 95% CI, -4.40 to -1.24; P<0.001 for superiority).
CONCLUSIONS


One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding. (Funded by Terumo; MASTER DAPT ClinicalTrials.gov number, NCT03023020.).",2021,"A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P = 0.001 for noninferiority).","['patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear', 'Patients at High Bleeding Risk', 'One month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to']",['discontinue dual antiplatelet therapy immediately (abbreviated therapy'],"['intention-to-treat population', 'major adverse cardiac or cerebral event', 'net adverse clinical events', 'relevant nonmajor bleeding', 'net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",133.0,0.185092,"A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P = 0.001 for noninferiority).","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Frigoli', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tijssen', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Pim A L', 'Initials': 'PAL', 'LastName': 'Tonino', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Roffi', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Lesiak', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Bartunek', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hildick-Smith', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Stanković', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Schultz', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Paul J L', 'Initials': 'PJL', 'LastName': 'Ong', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Mirvat', 'Initials': 'M', 'LastName': 'Alasnag', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Alfredo E', 'Initials': 'AE', 'LastName': 'Rodriguez', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Moschovitis', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Peep', 'Initials': 'P', 'LastName': 'Laanmets', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Donahue', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': ""From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2108749']
1501,34473848,Should we individualize training based on force-velocity profiling to improve physical performance in athletes?,"The present study aimed to examine the effectiveness of an individualized training program based on force-velocity (FV) profiling on jumping, sprinting, strength, and power in athletes. Forty national level team sport athletes (20 ± 4years, 83 ± 13 kg) from ice-hockey, handball, and soccer completed a 10-week training intervention. A theoretical optimal squat jump (SJ)-FV-profile was calculated from SJ with five different loads (0, 20, 40, 60, and 80 kg). Based on their initial FV-profile, athletes were randomized to train toward, away, or irrespective (balanced training) of their initial theoretical optimal FV-profile. The training content was matched between groups in terms of set x repetitions but varied in relative loading to target the different aspects of the FV-profile. The athletes performed 10 and 30 m sprints, SJ and countermovement jump (CMJ), 1 repetition maximum (1RM) squat, and a leg-press power test before and after the intervention. There were no significant group differences for any of the performance measures. Trivial to small changes in 1RM squat (2.9%, 4.6%, and 6.5%), 10 m sprint time (1.0%, -0.9%, and -1.7%), 30 m sprint time (0.9%, -0.6%, and -0.4%), CMJ height (4.3%, 3.1%, and 5.7%), SJ height (4.8%, 3.7%, and 5.7%), and leg-press power (6.7%, 4.2%, and 2.9%) were observed in the groups training toward, away, or irrespective of their initial theoretical optimal FV-profile, respectively. Changes toward the optimal SJ-FV-profile were negatively correlated with changes in SJ height (r = -0.49, p < 0.001). Changes in SJ-power were positively related to changes in SJ-height (r = 0.88, p < 0.001) and CMJ-height (r = 0.32, p = 0.044), but unrelated to changes in 10 m (r = -0.02, p = 0.921) and 30 m sprint time (r = -0.01, p = 0.974). The results from this study do not support the efficacy of individualized training based on SJ-FV profiling.",2021,There were no significant group differences for any of the performance measures.,"['Forty national level team sport athletes (20±4yrs, 83±13 kg) from ice-hockey, handball, and soccer completed a', 'athletes']","['10-week training intervention', 'SJ and countermovement jump (CMJ), 1 repetition maximum (1RM) squat, and a leg-press power test', 'individualized training program']","['CMJ height', '1RM squat', '30 m sprint time', 'CMJ-height', 'SJ height', 'leg press power', '10 m sprint time', 'SJ-height', 'optimal SJ-FV-profile']","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0020748', 'cui_str': 'Ice hockey'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",,0.0223459,There were no significant group differences for any of the performance measures.,"[{'ForeName': 'Kolbjørn', 'Initials': 'K', 'LastName': 'Lindberg', 'Affiliation': 'Department of Sport Science and Physical Education, Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Solberg', 'Affiliation': 'Norwegian Olympic Federation, Oslo, Norway.'}, {'ForeName': 'Bent R', 'Initials': 'BR', 'LastName': 'Rønnestad', 'Affiliation': 'Department of Health and Exercise Physiology, Faculty of Social Sciences, Inland Norway, University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Martin Thorsen', 'Initials': 'MT', 'LastName': 'Frank', 'Affiliation': 'Department of Sport Science and Physical Education, Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Larsen', 'Affiliation': 'Department of Sport Science and Physical Education, Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Gøran', 'Initials': 'G', 'LastName': 'Abusdal', 'Affiliation': 'Department of Sport Science and Physical Education, Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Department of Sport Science and Physical Education, Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Gøran', 'Initials': 'G', 'LastName': 'Paulsen', 'Affiliation': 'Norwegian Olympic Federation, Oslo, Norway.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Sveen', 'Affiliation': 'Østfold University College, Halden, Norway.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Seynnes', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bjørnsen', 'Affiliation': 'Department of Sport Science and Physical Education, Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.14044']
1502,34473834,"Patients' preferred place of death: patients are willing to consider their preferences, but someone has to ask them.","BACKGROUND


end-of-life care is not always in line with end-of-life preferences, so patients do not always die at their preferred place of death (PPD). This study aims to identify factors associated with patients' PPD and changes in PPD.
METHODS


we prospectively collected data on PPD at four time points within 6 months from 230 acutely hospitalised older patients who were part of the control group in a stepped-wedge randomised controlled trial. Associations between patient characteristics and preferences were calculated using multivariable (multinomial) logistic regression analysis.
RESULTS


the mean age of participants was 80.7 years. 47.8% of the patients had no PPD at hospital admission. Patients previously admitted to hospital preferred to die at home (home versus no preference: odds ratio [OR] 2.38, 95% confidence interval [CI] 1.15-4.92; home versus healthcare facility: OR 3.25, 95% CI 1.15-9.16). Patients with more chronic diseases preferred the healthcare facility as their PPD (healthcare facility versus no preference: OR 1.33, 95% CI 1.09-1.61; healthcare facility versus home: OR 1.21, 95% CI 1.00-1.47). 32 of 65 patients changed their preference during follow-up, and most of these had no PPD at hospital admission (home versus no preference: OR 0.005, 95% CI ≤0.001-0.095) and poorer self-rated well-being (OR 1.82, 95% CI 1.07-3.08).
CONCLUSIONS


almost half of the patients had no PPD at baseline. Previous hospital admission, having more chronic diseases and living alone are associated with having a PPD. Introducing PPD could make older people aware of PPD and facilitate optimal palliative care.",2021,"32 of 65 patients changed their preference during follow-up, and most of these had no PPD at hospital admission (home versus no preference: OR","['32 of 65 patients changed their preference during follow-up, and most of these had no PPD at hospital admission (home versus no preference: OR', 'we prospectively collected data on PPD at four time points within 6 months from 230 acutely hospitalised older patients who were part of the control group in a stepped-wedge randomised controlled trial']",[],['place of death'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1273399', 'cui_str': 'Preferred place of death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4520464', 'cui_str': 'No preference'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0421611', 'cui_str': 'Place of death'}]",230.0,0.198954,"32 of 65 patients changed their preference during follow-up, and most of these had no PPD at hospital admission (home versus no preference: OR","[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'van Doorne', 'Affiliation': 'Section of Geriatric Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Marjon', 'Initials': 'M', 'LastName': 'van Rijn', 'Affiliation': 'Section of Geriatric Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Sjoerd M', 'Initials': 'SM', 'LastName': 'Dofferhoff', 'Affiliation': 'Section of Geriatric Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Dick L', 'Initials': 'DL', 'LastName': 'Willems', 'Affiliation': 'Section of Medical Ethics, Department of General Practice, Amsterdam Public Health Research Institute, Amsterdam University Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Bianca M', 'Initials': 'BM', 'LastName': 'Buurman', 'Affiliation': 'Section of Geriatric Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}]",Age and ageing,['10.1093/ageing/afab176']
1503,34480075,The effect of trichlormethiazide in autosomal dominant polycystic kidney disease patients receiving tolvaptan: a randomized crossover controlled trial.,"The vasopressin V2 receptor antagonist tolvaptan delays the progression of autosomal dominant polycystic kidney disease (ADPKD). However, some patients discontinue tolvaptan because of severe adverse aquaretic events. This open-label, randomized, controlled, counterbalanced, crossover trial investigated the effects of trichlormethiazide, a thiazide diuretic, in patients with ADPKD receiving tolvaptan (n = 10) who randomly received antihypertensive therapy with or without trichlormethiazide for 12 weeks. The primary and secondary outcomes included amount and osmolarity of 24-h urine and health-related quality-of-life (HRQOL) parameters assessed by the Kidney Disease Quality of Life-Short Form questionnaire, renal function slope, and plasma/urinary biomarkers associated with disease progression. There was a significant reduction in urine volume (3348 ± 584 vs. 4255 ± 739 mL; P < 0.001) and a significant increase in urinary osmolarity (182.5 ± 38.1 vs. 141.5 ± 38.1 mOsm; P = 0.001) in patients treated with trichlormethiazide. Moreover, trichlormethiazide improved the following HRQOL subscales: effects of kidney disease, sleep, emotional role functioning, social functioning, and role/social component summary. No significant differences were noted in renal function slope or plasma/urinary biomarkers between patients treated with and without trichlormethiazide. In patients with ADPKD treated with tolvaptan, trichlormethiazide may improve tolvaptan tolerability and HRQOL parameters.",2021,"Moreover, trichlormethiazide improved the following HRQOL subscales: effects of kidney disease, sleep, emotional role functioning, social functioning, and role/social component summary.","['autosomal dominant polycystic kidney disease patients receiving', 'patients with ADPKD receiving tolvaptan (n\u2009=\u200910']","['tolvaptan', 'trichlormethiazide', 'vasopressin V2 receptor antagonist tolvaptan', 'trichlormethiazide, a thiazide diuretic', 'tolvaptan, trichlormethiazide', 'antihypertensive therapy with or without trichlormethiazide']","['renal function slope or plasma/urinary biomarkers', 'tolvaptan tolerability and HRQOL parameters', 'HRQOL subscales: effects of kidney disease, sleep, emotional role functioning, social functioning, and role/social component summary', 'amount and osmolarity of 24-h urine and health-related quality-of-life (HRQOL) parameters assessed by the Kidney Disease Quality of Life-Short Form questionnaire, renal function slope, and plasma/urinary biomarkers associated with disease progression', 'urine volume', 'urinary osmolarity']","[{'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0040899', 'cui_str': 'Trichlormethiazide'}, {'cui': 'C0162829', 'cui_str': 'V2 Receptors'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}]",,0.0180006,"Moreover, trichlormethiazide improved the following HRQOL subscales: effects of kidney disease, sleep, emotional role functioning, social functioning, and role/social component summary.","[{'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Uchiyama', 'Affiliation': 'Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. kiyo.0817.piyo@gmail.com.'}, {'ForeName': 'Chigusa', 'Initials': 'C', 'LastName': 'Kitayama', 'Affiliation': 'Department of Nephrology, Japan Community Health Care Organization (JCHO) Sendai Hospital, Miyagi, 981-8501, Japan.'}, {'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Yanai', 'Affiliation': 'Department of Nephrology, Tokyo Shinagawa Hospital, Tokyo, 140-8522, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Ishibashi', 'Affiliation': 'Division of Nephrology, Japanese Red Cross Medical Center, 4-1-22 Hiroo, Shibuya-ku, Tokyo, 150-8935, Japan.'}]",Scientific reports,['10.1038/s41598-021-97113-w']
1504,34480960,Quality of life after simultaneously integrated boost with intensity-modulated versus conventional radiotherapy with sequential boost for adjuvant treatment of breast cancer: 2-year results of the multicenter randomized IMRT-MC2 trial.,"BACKGROUND


We recently published 2-year results of the prospective, randomized IMRT-MC2 trial, showing non-inferior local control and cosmesis in breast cancer patients after conventionally fractionated intensity-modulated radiotherapy with simultaneously integrated boost (IMRT-SIB), compared to 3D-conformal radiotherapy with sequential boost (3D-CRT-seqB). Here, we report on 2-year quality of life results.
PATIENTS AND METHODS


502 patients were enrolled and randomized to IMRT-SIB (50.4 Gy in 1.8 Gy fractions with a 64.4 Gy SIB to the tumor bed) or to 3D-CRT-seqB (50.4 Gy in 1.8 Gy fractions, followed by a sequential boost of 16 Gy in 2 Gy fractions). For quality of life (QoL) assessment, patients completed the QLQ-C30 and QLQ-BR23 questionnaires at baseline, 6 weeks and 2 years after radiotherapy.
RESULTS


Significant differences between treatment arms were seen 6 weeks after radiotherapy for pain (22.3 points for IMRT vs. 27.0 points for 3D-CRT-seqB; p = 0.033) and arm symptoms (18.1 points for IMRT vs. 23.6 points for 3D-CRT-seqB; p = 0.013), both favoring IMRT-SIB. Compared to baseline values, both arms showed significant improvement in global score (IMRT: p = 0.009; 3D-CRT: p = 0.001) after 2 years, with slight deterioration on the role (IMRT: p = 0.008; 3-D-CRT: p = 0.001) and social functioning (IMRT: p = 0.013, 3D-CRT: p = 0.001) as well as the future perspectives scale (IMRT: p = 0.003; 3D-CRT: p = 0.0034).
CONCLUSION


This is the first randomized phase III trial demonstrating that IMRT-SIB was associated with slightly superior QoL compared to 3-D-CRT-seqB. These findings further support the clinical implementation of SIB in adjuvant breast cancer treatment.",2021,"Compared to baseline values, both arms showed significant improvement in global score (IMRT: p=0.009; 3D-CRT: p=0.001,) after 2 years, with slight deterioration on the role (IMRT: p=0.008; 3-D-CRT: p=0.001,) and social functioning (IMRT: p=0.013, 3D-CRT: p=0.001) as well as the future perspectives scale (IMRT: p=0.003; 3D-CRT: p=0.0034).
","['breast cancer', '502 patients were enrolled and randomized to IMRT-SIB (50.4 Gy in 1.8 Gy fractions with a 64.4 Gy SIB to the tumor bed) or to', 'breast cancer patients after']","['conventionally fractionated intensity-modulated radiotherapy with simultaneously integrated boost (IMRT-SIB', '3D-CRT-seqB', 'intensity-modulated versus conventional radiotherapy']","['2-year quality of life results', 'For quality of life (QoL) assessment', 'global score', 'Quality of life', 'QLQ-C30 and QLQ-BR23 questionnaires', 'pain', 'social functioning']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",502.0,0.0491595,"Compared to baseline values, both arms showed significant improvement in global score (IMRT: p=0.009; 3D-CRT: p=0.001,) after 2 years, with slight deterioration on the role (IMRT: p=0.008; 3-D-CRT: p=0.001,) and social functioning (IMRT: p=0.013, 3D-CRT: p=0.001) as well as the future perspectives scale (IMRT: p=0.003; 3D-CRT: p=0.0034).
","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Forster', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Hommertgen', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Matthias Felix', 'Initials': 'MF', 'LastName': 'Häfner', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Arians', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'König', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Semi Ben', 'Initials': 'SB', 'LastName': 'Harrabi', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Schlampp', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Köhler', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Meixner', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Heinrich', 'Affiliation': 'Department of Radiation Oncology, Eberhard-Karls-University Tuebingen, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Weidner', 'Affiliation': 'Department of Radiation Oncology, Eberhard-Karls-University Tuebingen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hüsing', 'Affiliation': 'Division of Biostatistics, Coordination Centre for Clinical Trials, University of Heidelberg, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Sohn', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Heidelberg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Golatta', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Heidelberg, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Hof', 'Affiliation': 'Strahlentherapie Rhein-Pfalz, Neustadt, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany; Department of Radiation Oncology, University Hospital Schleswig Holstein, Kiel, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany; Department of Radiation Oncology, University Hospital Schleswig Holstein, Kiel, Germany; Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg Ion-Beam Therapy Center (HIT), Department of Radiation Oncology, Heidelberg University Hospital, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Hörner-Rieber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany; Department of Radiation Oncology, University Hospital Schleswig Holstein, Kiel, Germany; German Cancer Consortium (DKTK), partner site, Heidelberg, Germany. Electronic address: juliane.hoerner-rieber@med.uni-heidelberg.de.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.08.019']
1505,34480873,The impact of preoperative pelvic pain on outcomes after vaginal reconstructive surgery.,"BACKGROUND


Pelvic pain is a debilitating condition that is common among women with pelvic floor disorders. Limited information is known about the impact of preoperative pelvic pain on outcomes after vaginal reconstructive surgery.
OBJECTIVE


This study aimed to compare the outcomes after vaginal reconstructive surgery between women with and without preoperative pelvic pain.
STUDY DESIGN


Baseline and postoperative data were analyzed from the ""Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial."" The multicenter trial involved women with anterior prolapse without symptoms of stress incontinence randomized to receive either a midurethral sling or sham incisions during a vaginal reconstructive surgery. Participants completed the visual analog scale adapted for suprapubic pain and Pelvic Floor Distress Inventory at baseline, 3 months, and 12 months. Preoperative pelvic pain was defined as a response of ""5"" or greater on pain on the visual analog scale or answering ""moderately"" or ""quite a bit"" on the Pelvic Floor Distress Inventory question, ""Do you usually experience pain in the lower abdomen or genital area?"" Outcomes and complication rates were compared between women with and without pelvic pain.
RESULTS


The ""Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial"" participants included 112 women with pelvic pain (58 had a midurethral sling and 54 had sham incisions) and 212 women without pelvic pain (105 had a midurethral sling and 107 had sham incisions). Women who had a midurethral sling and pelvic pain were younger than women without pelvic pain (60.3±12.1 vs 65.1±8.6; P=.004). Women who had sham incisions and pelvic pain were more likely of Hispanic ethnicity than women without pelvic pain (27.8% vs 9.4%; P=.002). Patient improvement based on the Patient Global Impression of Improvement scale did not differ between arms. Women with pelvic pain had greater improvement on the visual analog scale pain scores after a surgical procedure at 3 months (-3.1±2.9 vs -0.4±1.6; P<.001) and at 12 months (-3.4±3.0 vs -0.6±1.6; P<.001) than women without pain, although their pain scores remained higher than those without preoperative pelvic pain at all time points (P<.001 for all). Similar improvements were found on the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. The differences observed were not affected by whether women were in the midurethral sling or sham arm of the trial. Postoperative urinary tract infection and incomplete bladder emptying did not differ between the groups.
CONCLUSION


Women with preoperative pelvic pain experienced significant improvements in pain and pelvic floor symptoms with vaginal reconstructive surgery and had similar subjective improvement postoperatively compared with women without preoperative pelvic pain. Reassuringly, the performance of a midurethral sling did not have an impact on the results.",2021,The differences observed were not affected by whether women were in the midurethral sling or sham arm of the trial.,"['women with and without preoperative pelvic pain', 'women with pelvic floor disorders', 'OPUS participants included 112 women with pelvic pain (58 had a midurethral sling and 54 had sham incisions) and 212 women without pelvic pain (105 had a midurethral sling and 107 had sham incisions', 'women with anterior prolapse without symptoms of stress incontinence']","['Vaginal Prolapse Repair and Midurethral Sling', 'vaginal reconstructive surgery', 'Preoperative Pelvic Pain', 'midurethral sling or sham incisions during surgery', 'Vaginal Reconstructive Surgery']","['pelvic pain', 'Postoperative urinary tract infection, and incomplete bladder emptying', 'Patient Global Impression of Improvement', ' Outcomes and complication rates', 'pain and pelvic floor symptoms', 'PFDI and pelvic floor impact questionnaires', 'pain VAS scores', 'Hispanic ethnicity', 'visual analogue pain scale adapted for suprapubic pain (VAS) and Pelvic Floor Distress Inventory (PFDI) questionnaire', 'midurethral sling and pelvic pain', 'Preoperative pelvic pain', 'pain scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C3178892', 'cui_str': 'Pelvic Floor Diseases'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2938890', 'cui_str': 'Vaginal prolapse repair'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}]","[{'cui': 'C2938890', 'cui_str': 'Vaginal prolapse repair'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0403709', 'cui_str': 'Postoperative urinary tract infection'}, {'cui': 'C0344365', 'cui_str': 'Incomplete emptying of bladder'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0241310', 'cui_str': 'Suprapubic pain'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",112.0,0.175937,The differences observed were not affected by whether women were in the midurethral sling or sham arm of the trial.,"[{'ForeName': 'Elisabeth C', 'Initials': 'EC', 'LastName': 'Sappenfield', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Hartford Hospital, Hartford, CT. Electronic address: elisabeth.sappenfield@hhchealth.org.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Tulikangas', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Hartford Hospital, Hartford, CT.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.08.040']
1506,34509972,Minimal clinically important difference of modified dynamic gait index in people with neurological disorders.,"BACKGROUND


The minimal clinically important difference (MCID) of modified Dynamic Gait Index (mDGI) has not yet been determined for People with Neurological Disorders (PwND).
RESEARCH QUESTION


To establish the MCID of the mDGI to determine clinically meaningful improvement in balance and gait in PwND.
METHODS


In this longitudinal study from a randomised clinical trial, 55 participants both in and outpatients with neurological disorders, received fifteen 40-minute rehabilitation sessions. Inpatients received daily treatments over a period of three weeks while outpatients received three treatments/week over a period of five weeks. An anchor-based method using percentage rating of improvement in balance (Activities Balance Confidence scale, ABC) was used to determine the MCID of mDGI. The MCID was defined as the minimum change in mDGI total score (post - pre intervention) that was needed to perceive at least a 10 % improvement on the ABC scale. A Receiver Operating Characteristic curve was used to define the cut-off for the optimal MCID of the mDGI discriminating between improved and not improved participants.
RESULTS


The MCID of the mDGI total score was 6 points and Area under the Curve was 0.64. For the mDGI time sub-scores the MCID was 2 points and Area under the Curve was 0.6.
SIGNIFICANCE


The MCID of balance and gait improvement measured by mDGI was prudently establish at ≥7 points, meaning that this is the minimum improvement score PwND need to get to perceive a clinically relevant change in their balance and gait confidence. These reference values can be a tool incorporated into clinicians daily practice to interpret mDGI change scores helping to determine whether the intervention is effective; to develop clinical tailored intervention goals and to establish meaningful perceived change in PwND.",2021,"For the mDGI time sub-scores the MCID was 2 points and Area under the Curve was 0.6.
","['people with neurological disorders', 'People with Neurological Disorders (PwND', '55 participants both in and outpatients with neurological disorders, received fifteen 40-minute rehabilitation sessions']",[],"['MCID of the mDGI total score', 'ABC scale', 'mDGI total score', 'modified dynamic gait index', 'balance (Activities Balance Confidence scale, ABC']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]",[],"[{'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",55.0,0.0436036,"For the mDGI time sub-scores the MCID was 2 points and Area under the Curve was 0.6.
","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Corrini', 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro, 66-20148, Milano, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Torchio', 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro, 66-20148, Milano, Italy.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Anastasi', 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro, 66-20148, Milano, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Parelli', 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro, 66-20148, Milano, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Meotti', 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro, 66-20148, Milano, Italy.'}, {'ForeName': 'Albino', 'Initials': 'A', 'LastName': 'Spedicato', 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro, 66-20148, Milano, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Groppo', 'Affiliation': 'U.O. Clinica Neurologica, III Ospedale San Paolo Via Antonio di Rudini 8, 20142, Milano, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': ""D'Arma"", 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro, 66-20148, Milano, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Grosso', 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro, 66-20148, Milano, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Montesano', 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro, 66-20148, Milano, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Cattaneo', 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro, 66-20148, Milano, Italy; Department of Pathophysiology and Transplantation, University of Milan 20100, Milan, Italy. Electronic address: dcattaneo@dongnocchi.it.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Gervasoni', 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro, 66-20148, Milano, Italy.'}]",Gait & posture,['10.1016/j.gaitpost.2021.08.024']
1507,34509883,Safety and efficacy of rufinamide in children and adults with Lennox-Gastaut syndrome: A post hoc analysis from Study 022.,"BACKGROUND


Lennox-Gastaut syndrome (LGS) is a developmental and epileptic encephalopathy with the first symptoms usually appearing during early childhood. Due to the highly variable underlying etiologies, LGS cannot be considered as one disease but as an electro-clinical entity, often challenging to diagnose early and treat accordingly. The anti-seizure medication, rufinamide, is indicated for the adjunctive treatment of patients with LGS aged ≥1 year. This post hoc analysis assessed the safety and efficacy of adjunctive rufinamide for total and tonic-atonic seizures during Study 022 in children (aged <16 years) and adults (aged ≥16 years).
METHODS


Randomized, placebo-controlled, phase III Study 022 included patients with a diagnosis of LGS and a history of multiple seizure types (including tonic-atonic or astatic seizures and atypical absence seizures; ≥90 seizures in the month prior to baseline). Assessments included monitoring of treatment-emergent adverse events (TEAEs), percent change in tonic-atonic seizure frequency/28 days during the double-blind phase relative to study baseline (a primary endpoint), and percentage of patients with ≥25%, ≥50%, or ≥75% reduction in seizure frequency relative to baseline.
RESULTS


Of 138 enrolled patients, 74 received rufinamide (<16 years, n = 49 [66%]) and 64 received placebo (<16 years, n = 43 [67%]). Incidence of TEAEs was generally similar between age groups. The frequency (per 28 days) of tonic-atonic seizures was reduced with rufinamide (vs. placebo) in both younger and older patients: age <16 years (-41% vs. -6%), age ≥16 years (-55% vs. +16%) (p < 0.025; both age groups). In patients aged <16 years receiving rufinamide, 38% and 17% achieved ≥50% and ≥75% reductions in tonic-atonic seizure frequency vs. 18% and 3% with placebo, respectively. Corresponding responder rates for patients aged ≥16 years were 52% and 32% (rufinamide) vs. 15% and 5% (placebo), respectively.
CONCLUSIONS


In this post hoc analysis, adjunctive rufinamide was well tolerated and improved seizure control in patients with LGS, irrespective of age.",2021,"In this post hoc analysis, adjunctive rufinamide was well tolerated and improved seizure control in patients with LGS, irrespective of age.","['patients with LGS aged ≥1\u202fyear', 'total and tonic-atonic seizures during Study 022 in children (aged <16\u202fyears) and adults (aged ≥16\u202fyears', 'children and adults with Lennox-Gastaut syndrome', 'phase III Study 022 included patients with a diagnosis of LGS and a history of multiple seizure types (including tonic-atonic or astatic seizures and atypical absence seizures; ≥90 seizures in the month prior to baseline', '138 enrolled patients, 74 received rufinamide (<16\u202fyears, n\u202f=\u202f49 [66%]) and 64 received']","['placebo', 'rufinamide (vs. placebo', 'adjunctive rufinamide', 'rufinamide']","['Safety and efficacy', 'safety and efficacy', 'Incidence of TEAEs', 'tonic-atonic seizures', 'monitoring of treatment-emergent adverse events (TEAEs), percent change in tonic-atonic seizure frequency/28\u202fdays', 'tolerated and improved seizure control', 'tonic-atonic seizure frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0270846', 'cui_str': 'Epileptic drop attack'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0595948', 'cui_str': 'Atypical absence seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0213404', 'cui_str': 'rufinamide'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0213404', 'cui_str': 'rufinamide'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0270846', 'cui_str': 'Epileptic drop attack'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",138.0,0.518787,"In this post hoc analysis, adjunctive rufinamide was well tolerated and improved seizure control in patients with LGS, irrespective of age.","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Arzimanoglou', 'Affiliation': ""Department of Paediatric Clinical Epileptology, Sleep Disorders and Functional Neurology, Member of the ERN EpiCARE, University Hospitals of Lyon (HCL), Lyon 60700, France; Epilepsy Research Coordinator, Children's Hospital San Juan de Dios, Member of the ERN EpiCARE, Barcelona 08950, Spain. Electronic address: aarzimanoglou@orange.fr.""}, {'ForeName': 'Milka', 'Initials': 'M', 'LastName': 'Pringsheim', 'Affiliation': 'Clinic for Neuropediatrics and Neurological Rehabilitation, Epilepsy Center for Children and Adolescents, Krankenhausstr, Vogtareuth 20 83569, Germany; Research Institute for Rehabilitation, Transition and Palliation, PMU Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Gerhard Josef', 'Initials': 'GJ', 'LastName': 'Kluger', 'Affiliation': 'Clinic for Neuropediatrics and Neurological Rehabilitation, Epilepsy Center for Children and Adolescents, Krankenhausstr, Vogtareuth 20 83569, Germany; Research Institute for Rehabilitation, Transition and Palliation, PMU Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Genton', 'Affiliation': 'Department of Neurology, Centre Hospitalier, Avenue des Tamaris, 13100 Aix-en-Provence, France.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Perdomo', 'Affiliation': 'Eisai Inc., 100 Tice Boulevard, Woodcliff Lake, NJ 07677, United States.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., 100 Tice Boulevard, Woodcliff Lake, NJ 07677, United States.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.108275']
1508,34507009,Moderator effects in a randomized controlled trial of the Common Elements Treatment Approach (CETA) for intimate partner violence and hazardous alcohol use in Zambia.,"BACKGROUND


Intimate partner violence (IPV) and hazardous alcohol use are prevalent and co-occurring problems in low- and middle-income countries (LMICs). While limited evidence suggests that cognitive behavioral therapy (CBT) interventions can help address these problems, few randomized trials in LMICs have investigated moderators of treatment effectiveness. This study explores moderating factors impacting responsiveness to a CBT-based intervention for IPV and hazardous alcohol use among couples in Zambia.
METHODS


Data were obtained from a completed randomized trial of a CBT-based intervention, the Common Elements Treatment Approach (CETA), among 248 couples in Lusaka. Female experiences of IPV and male alcohol use were measured at baseline and 12 months post-baseline. Mixed effects regression models were used to evaluate each moderator: age, educational attainment, employment status, marital status, physical disability, HIV status, trauma exposure, depression, post-traumatic stress disorder, alcohol use disorder, and substance use.
RESULTS


Treatment effectiveness for male alcohol use was moderated by female substance use, with greater reductions among men whose partners reported using non-alcohol substances (e.g., cannabis) (p < 0.01). Other marginally significant moderators (p < 0.15) of change in male alcohol use included female education and male depression, substance use, and moderate-to-severe alcohol use at baseline. Female HIV status and depression were marginally significant moderators of change in IPV.
CONCLUSIONS


This study suggests that CETA may be especially effective for highly symptomatic individuals with comorbid mental and behavioral health problems, a promising finding given that such comorbidity is widespread in LMICs. Psychotherapeutic treatments that can flexibly and simultaneously address co-occurring problems are needed.",2021,"This study explores moderating factors impacting responsiveness to a CBT-based intervention for IPV and hazardous alcohol use among couples in Zambia.
","['248 couples in Lusaka', 'intimate partner violence and hazardous alcohol use in Zambia', 'couples in Zambia', 'highly symptomatic individuals with comorbid mental and behavioral health problems']","['Common Elements Treatment Approach (CETA', 'CETA', 'CBT-based intervention, the Common Elements Treatment Approach (CETA', 'CBT-based intervention', 'cognitive behavioral therapy (CBT) interventions']","['Female HIV status and depression', 'educational attainment, employment status, marital status, physical disability, HIV status, trauma exposure, depression, post-traumatic stress disorder, alcohol use disorder, and substance use']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",248.0,0.0114574,"This study explores moderating factors impacting responsiveness to a CBT-based intervention for IPV and hazardous alcohol use among couples in Zambia.
","[{'ForeName': 'Shoshanna L', 'Initials': 'SL', 'LastName': 'Fine', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: slfine@jhu.edu.'}, {'ForeName': 'Jeremy C', 'Initials': 'JC', 'LastName': 'Kane', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Epidemiology, Columbia Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Skavenski', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108995']
1509,34506596,"Effects of an equol-containing supplement on advanced glycation end products, visceral fat and climacteric symptoms in postmenopausal women: A randomized controlled trial.","INTRODUCTION


Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered a potentially effective agent for relieving climacteric symptoms, for the prevention of lifestyle-related diseases, and for aging care in postmenopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging and climacteric symptoms with respect to internally produced equol in postmenopausal women.
METHODS


A single-center, randomized controlled trial (registration number: UMIN000030975) on 57 postmenopausal Japanese women (mean age: 56±5.37 years) was conducted. Twenty-seven women received the equol supplement, while the remaining received control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese postmenopausal women.
RESULTS


Three months post-intervention, the treatment group showed significant improvement in climacteric symptoms compared to the control group (81% vs. 53%, respectively, p = 0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations, significant improvement in skin autofluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers.
CONCLUSION


Women receiving equol supplementation showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously produced equol to improve skin aging and visceral fat in certain populations.",2021,"Three months post-intervention, the treatment group showed significant improvement in climacteric symptoms compared to the control group (81% vs. 53%, respectively, p = 0.045).","['postmenopausal women', 'Japanese postmenopausal women', 'Twenty-seven women received the', '57 postmenopausal Japanese women (mean age: 56±5.37 years']","['supplemented equol and endogenously produced equol', 'equol-containing supplement', 'equol supplementation', 'equol supplement']","['advanced glycation end products, visceral fat and climacteric symptoms', 'Climacteric symptoms', 'climacteric symptoms', 'metabolism and aging and climacteric symptoms', 'skin autofluorescence', 'skin aging and visceral fat']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0059497', 'cui_str': 'Equol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1306878', 'cui_str': 'Climacteric discomfort'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0544711', 'cui_str': 'Autofluorescence'}]",57.0,0.0443922,"Three months post-intervention, the treatment group showed significant improvement in climacteric symptoms compared to the control group (81% vs. 53%, respectively, p = 0.045).","[{'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Yoshikata', 'Affiliation': 'Hamasite Clinic, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Khin Zay Yar', 'Initials': 'KZY', 'LastName': 'Myint', 'Affiliation': 'Tokyo Midtown Medical Center, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ohta', 'Affiliation': 'Sanno Medical Center, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Ishigaki', 'Affiliation': 'Sendai Medical Center, Sendai-shi, Miyagi, Japan.'}]",PloS one,['10.1371/journal.pone.0257332']
1510,34506563,A novel noninvasive formula for predicting cirrhosis in patients with chronic hepatitis C.,"Evaluating liver fibrosis is crucial for disease severity assessment, treatment decisions, and hepatocarcinogenic risk prediction among patients with chronic hepatitis C. In this retrospective multicenter study, we aimed to construct a novel model formula to predict cirrhosis. A total of 749 patients were randomly allocated to training and validation sets at a ratio of 2:1. Liver stiffness measurement (LSM) was made via transient elastography using FibroScan. Patients with LSM ≥12.5 kPa were regarded as having cirrhosis. The best model formula for predicting cirrhosis was constructed based on factors significantly and independently associated with LSM (≥12.5 kPa) using multivariate regression analysis. Among the 749 patients, 198 (26.4%) had LSM ≥12.5 kPa. In the training set, multivariate analysis identified logarithm natural (ln) type IV collagen 7S, ln hyaluronic acid, and ln Wisteria floribunda agglutinin positive Mac-2-binding protein (WFA+-Mac-2 BP) as the factors that were significantly and independently associated with LSM ≥12.5 kPa. Thus, the formula was constructed as follows: score = -6.154 + 1.166 × ln type IV collagen 7S + 0.526 × ln hyaluronic acid + 1.069 × WFA+-Mac-2 BP. The novel formula yielded the highest area under the curve (0.882; optimal cutoff, -0.381), specificity (81.5%), positive predictive values (62.6%), and predictive accuracy (81.6%) for predicting LSM ≥12.5 kPa among fibrosis markers and indices. These results were almost similar to those in the validated set, indicating the reproducibility and validity of the novel formula. The novel formula scores were significantly, strongly, and positively correlated with LSM values in both the training and validation data sets (correlation coefficient, 0.721 and 0.762; p = 2.67 × 10-81 and 1.88 × 10-48, respectively). In conclusion, the novel formula was highly capable of diagnosing cirrhosis in patients with chronic hepatitis C and exhibited better diagnostic performance compared to conventional fibrosis markers and indices.",2021,"The novel formula scores were significantly, strongly, and positively correlated with LSM values in both the training and validation data sets (correlation coefficient, 0.721 and 0.762; p = 2.67","['patients with chronic hepatitis C', '749 patients, 198 (26.4%) had LSM ≥12.5 kPa', '749 patients']",[],"['Liver stiffness measurement (LSM', 'LSM values', 'logarithm natural (ln) type IV collagen 7S, ln hyaluronic acid, and ln Wisteria floribunda agglutinin positive Mac-2-binding protein (WFA+-Mac-2 BP', 'positive predictive values', 'predictive accuracy', 'novel formula scores', 'diagnostic performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}]",[],"[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0009333', 'cui_str': 'Collagen type IV'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0078501', 'cui_str': 'Wisteria floribunda lectin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0217525', 'cui_str': 'LGALS3BP protein, human'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",749.0,0.0339022,"The novel formula scores were significantly, strongly, and positively correlated with LSM values in both the training and validation data sets (correlation coefficient, 0.721 and 0.762; p = 2.67","[{'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Atsukawa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsubota', 'Affiliation': 'Core Research Facilities, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Kondo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Sawako', 'Initials': 'S', 'LastName': 'Uchida-Kobayashi', 'Affiliation': 'Department of Hepatology, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takaguchi', 'Affiliation': 'Department of Hepatology, Kagawa Prefectural Central Hospital, Kagawa, Japan.'}, {'ForeName': 'Akemi', 'Initials': 'A', 'LastName': 'Tsutsui', 'Affiliation': 'Department of Hepatology, Kagawa Prefectural Central Hospital, Kagawa, Japan.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Nozaki', 'Affiliation': 'Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Chuma', 'Affiliation': 'Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Hidaka', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Motoh', 'Initials': 'M', 'LastName': 'Iwasa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mie University School of Medicine, Mie, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tamai', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mie University School of Medicine, Mie, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Tobari', 'Affiliation': ""Department of Internal Medicine and Gastroenterology, Tokyo Women's Medical University Yachiyo Medical Center, Chiba, Japan.""}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Matsuura', 'Affiliation': 'Department of Virology and Liver Unit, Nagoya City University, Graduate School of Medical Sciences, Aichi, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Nagura', 'Affiliation': 'Department of Virology and Liver Unit, Nagoya City University, Graduate School of Medical Sciences, Aichi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Abe', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, Shinmatusdo Central General Hospital, Matsudo, Japan.'}, {'ForeName': 'Keizo', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, Shinmatusdo Central General Hospital, Matsudo, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Okubo', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Chiba Hokusoh Hospital, Chiba, Chiba, Japan.'}, {'ForeName': 'Taeang', 'Initials': 'T', 'LastName': 'Arai', 'Affiliation': 'Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Itokawa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Toyoda', 'Affiliation': 'Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Enomoto', 'Affiliation': 'Department of Hepatology, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Tamori', 'Affiliation': 'Department of Hepatology, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Norifumi', 'Initials': 'N', 'LastName': 'Kawada', 'Affiliation': 'Department of Hepatology, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Takei', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mie University School of Medicine, Mie, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0257166']
1511,34478124,"Post Hoc Biomarker Analyses from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar® Gel) for Persistently Active Systemic Lupus Erythematosus.","INTRODUCTION


We conducted post hoc analyses of biomarker results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar® Gel) in patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids.
METHODS


Adults with active SLE and moderate to severe rash and/or arthritis were enrolled in the primary study. Patients had active SLE despite treatment with stable glucocorticoids, antimalarials, and nonsteroidal anti-inflammatory drugs and/or immunosuppressants. Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day for 4 weeks and then twice weekly through week 24. Blood samples were analyzed for serum cytokines and complement proteins using enzyme-linked immunosorbent or Luminex assays and for circulating leukocytes using flow cytometry. Biomarker levels were reported as percentages of the baseline and were further evaluated in subgroups stratified by baseline SLE Disease Activity Index-2000 (SLEDAI-2K) scores (< 10 vs. ≥ 10), baseline anti-double-stranded DNA levels (< 15 IU/mL vs. ≥ 15 IU/mL), and BILAG-based Combined Lupus Assessment (BICLA) responses at week 20 and 24.
RESULTS


RCI treatment resulted in reduced levels of B cell-activating factor and interleukin-6 cytokines in all subgroups compared with placebo. RCI treatment also resulted in lower levels of CD19 +  B cells and CD19 + IgD - CD27 - CD95 +  atypical activated memory B cells than did placebo in the higher baseline disease activity subgroups and in BICLA non-responders. Furthermore, RCI treatment led to greater increases in complement component (C)3 and C4 levels than did placebo in the higher baseline disease activity subgroups and in BICLA responders.
CONCLUSIONS


RCI may reduce inflammation through B cell immunomodulation in patients with persistently active SLE, particularly in those with higher disease activity.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT02953821.",2021,"RESULTS


RCI treatment resulted in reduced levels of B cell-activating factor and interleukin-6 cytokines in all subgroups compared with placebo.","['Adults with active SLE and moderate to severe rash and/or arthritis were enrolled in the primary study', 'patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids', 'Patients had active SLE despite treatment with stable glucocorticoids, antimalarials, and nonsteroidal anti-inflammatory drugs and/or immunosuppressants', 'Persistently Active Systemic Lupus Erythematosus']","['repository corticotropin injection (RCI; Acthar® Gel', 'Repository Corticotropin Injection (Acthar® Gel', 'RCI or placebo', 'Placebo', 'placebo']","['lower levels of CD19 +  B cells and CD19 + IgD - CD27 - CD95 +  atypical activated memory B cells', 'complement component (C)3 and C4 levels', 'Biomarker levels', 'levels of B cell-activating factor and interleukin-6 cytokines', 'baseline SLE Disease Activity Index-2000 (SLEDAI-2K) scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}]","[{'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0718234', 'cui_str': 'Acthar'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0020843', 'cui_str': 'Immunoglobulin D'}, {'cui': 'C0054949', 'cui_str': 'Lymphocyte antigen CD27'}, {'cui': 'C0245662', 'cui_str': 'Lymphocyte antigen CD95'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0009506', 'cui_str': 'Complement component C3'}, {'cui': 'C0446414', 'cui_str': 'Level of the fourth cervical vertebra'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.675524,"RESULTS


RCI treatment resulted in reduced levels of B cell-activating factor and interleukin-6 cytokines in all subgroups compared with placebo.","[{'ForeName': 'Anca D', 'Initials': 'AD', 'LastName': 'Askanase', 'Affiliation': 'Columbia University Medical Center, 630 West 168th Street, P&S 3-3450, New York, NY, 10032, USA. ada20@cumc.columbia.edu.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Wright', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Enxu', 'Initials': 'E', 'LastName': 'Zhao', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Bilyk', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Furie', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}]",Rheumatology and therapy,['10.1007/s40744-021-00351-7']
1512,34480632,Bolus intravenous 0.9% saline leads to interstitial permeability pulmonary edema in healthy volunteers.,"PURPOSE


Bolus intravenous administration of 0.9% saline has been associated with the development of pulmonary edema, and increased mortality. An animal model has previously demonstrated that rapid intravenous administration of 0.9% saline was associated with non-hydrostatic lung injury with increased lung lavage protein. We hypothesized that this non-hydrostatic effect would also occur in human volunteers.
METHODS


In a randomized, cross-over study of 14 healthy male subjects, the lung lavage protein concentration and cardiorespiratory effects of an intervention with rapid intravenous administration of 30 mL/kg of 0.9% saline were compared with sham intervention. Bronchoalveolar lavage (BAL) was performed after fluid administration. Doppler echocardiography, lung ultrasound, pulmonary function tests, and blood sampling were performed before and after each intervention.
RESULTS


The BAL total protein concentration was greater after 0.9% saline administration than with sham (196.1 µg/mL (SD 87.6) versus 129.8 µg/mL (SD 55.4), respectively (p = 0.020). Plasma angiopoietin-2 concentration was also increased to 2.26 ng/mL (SD 0.87) after 0.9% saline administration compared with sham 1.53 ng/mL (SD 0.69) (p < 0.001). There were small increases in stroke volume (from 58 mL (IQR 51-74) to 66 mL (IQR 58-74), p = 0.045) and Doppler echocardiography left ventricle E/e' ratio (from 5.0 (IQR 4.5-6.0) to 5.7 (IQR 5.3-6.3), p = 0.007), but no changes to right ventricular function.
CONCLUSION


Rapid intravenous administration of 0.9% saline leads to interstitial permeability pulmonary edema in healthy human volunteers. Further research is now warranted to understand these effects in critically ill patients.",2021,"The BAL total protein concentration was greater after 0.9% saline administration than with sham (196.1 µg/mL (SD 87.6) versus 129.8 µg/mL (SD 55.4), respectively (p = 0.020).","['critically ill patients', '14 healthy male subjects', 'healthy volunteers', 'human volunteers', 'healthy human volunteers']",['rapid intravenous administration of 30\xa0mL/kg of 0.9% saline'],"['lung lavage protein concentration and cardiorespiratory effects', 'stroke volume', 'Doppler echocardiography, lung ultrasound, pulmonary function tests, and blood sampling', 'interstitial permeability pulmonary edema', ""Doppler echocardiography left ventricle E/e' ratio"", 'BAL total protein concentration', 'Plasma angiopoietin-2 concentration', 'Bronchoalveolar lavage (BAL']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0427716', 'cui_str': 'Protein concentration, test strip measurement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0540511', 'cui_str': 'Angiopoietin 2'}]",14.0,0.15655,"The BAL total protein concentration was greater after 0.9% saline administration than with sham (196.1 µg/mL (SD 87.6) versus 129.8 µg/mL (SD 55.4), respectively (p = 0.020).","[{'ForeName': 'Hanmo', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Bedford Park, SA, 5042, Australia. Hanmo.Li@sa.gov.au.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bersten', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Bedford Park, SA, 5042, Australia.'}, {'ForeName': 'Ubbo', 'Initials': 'U', 'LastName': 'Wiersema', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Bedford Park, SA, 5042, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schembri', 'Affiliation': 'Respiratory Functions Laboratory, Flinders Medical Centre, Bedford Park, SA, Australia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cavallaro', 'Affiliation': 'Department of Critical Care Medicine, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Dani-Louise', 'Initials': 'DL', 'LastName': 'Dixon', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Bedford Park, SA, 5042, Australia.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Bedford Park, SA, 5042, Australia.'}]",European journal of applied physiology,['10.1007/s00421-021-04805-2']
1513,34481311,By utilizing technology can nursing students gain more confidence and decrease anxiety when communicating with chronically ill patients about their sexual relationship?,"INTRODUCTION


Effective communication is an essential part of nursing care. Nurses need to effectively communicate with patients, families, providers and staff. The purpose of this study was to show how the use of technology (i.e., video conferencing on an electronic device) could assist nursing students to gain more confidence and reduce anxiety when discussing difficult topics such as sexual intimacy.
METHODS


Pre-licensure nursing students were recruited to participate as part of regular class activities. A pre- and post-survey asking about their confidence and anxiety in communicating with patients was completed; then subjects were randomly placed into groups of 4 to 5 utilizing an electronic device. Student groups were able to communicate with a patient diagnosed with a medical condition that affected their intimacy by video conferencing in a breakout session for 15-20 min.
RESULTS


A total of 112 students participated. The majority of students stated that communicating about relationships and intimacy issues with chronically ill patients was not as difficult as they anticipated. About 82% of students liked using a video conferencing tool although about half (n = 62) reported they still preferred a face-to-face in-person interaction. Results demonstrated a significant increase in confidence and decrease in anxiety score (p = .001) before and after the intimacy communication activity.
CONCLUSIONS


In conclusion, the use of technology can be an effective learning tool to teach pre-licensure nursing students on how to communicate with patients effectively, especially for those difficult topics such as sexual intimacy.",2021,"Student groups were able to communicate with a patient diagnosed with a medical condition that affected their intimacy by video conferencing in a breakout session for 15-20 min.
","['112 students participated', 'Pre-licensure nursing students']",['electronic device'],['anxiety score'],"[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0023641', 'cui_str': 'Licensures, Nursing'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",112.0,0.0118929,"Student groups were able to communicate with a patient diagnosed with a medical condition that affected their intimacy by video conferencing in a breakout session for 15-20 min.
","[{'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Rickman Patrick', 'Affiliation': 'The Valley Foundation School of Nursing, San Jose State University, United States of America. Electronic address: sheri.rickmanpatrick@sjsu.edu.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Butzlaff', 'Affiliation': 'The Valley Foundation School of Nursing, San Jose State University, United States of America.'}]",Nurse education today,['10.1016/j.nedt.2021.105084']
1514,34481303,Standardized vs peer-played patients for learning how to break bad news in lung cancer: A prospective crossover study.,"CONTEXT


Residents in respiratory medicine are often confronted with breaking bad news to patients. In communication skill training, a recurring question is whether to use standardized or peer-played patients for simulation METHODS: In this prospective single-center crossover study in pulmonology residents, a range of scenarios were performed during training sessions using standardized or peer-played patients. The aim was to assess whether patient type did alter the quality of the role-play. The residents completed post-scenario questionnaires about the role-play of each scenario, but also pre- and post-session questionnaires about their perception of the effectiveness of both modalities, and pre- and post-testing questionnaires about the psychological impact of the training.
RESULTS


Collectively, 4 scenarios were performed 52 times and evaluated 208 times by 52 residents. The use of standardized patients appeared to improve the quality of the patient role (8.8 ± 1.0 vs. 8.3 ± 1.1; p = 0.001) and the general quality of role-play (8.8 ± 1.0 vs. 8.2 ± 0.9; p = 0.008), without affecting the quality of the physician role played by the resident. There were no significant differences between standardized and peer-played patients regarding learning interest or psychological impact. Regardless of the modality, the training sessions did appear to significantly affect the residents' evaluations of their ability to break bad news to patients (5.7 ± 1.1 vs. 7.4 ± 1.1; p < 10-4).
CONCLUSION


Our results did not point to a superiority of either of these modalities for learning how to break bad news. Both may be used, depending on the local resources.",2021,"Regardless of the modality, the training sessions did appear to significantly affect the residents' evaluations of their ability to break bad news to patients (5.7 ± 1.1 vs. 7.4 ± 1.1; p < 10-4).
","['lung cancer', 'pulmonology residents']",[],['general quality of role-play'],"[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0034060', 'cui_str': 'Pulmonary medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",4.0,0.00819287,"Regardless of the modality, the training sessions did appear to significantly affect the residents' evaluations of their ability to break bad news to patients (5.7 ± 1.1 vs. 7.4 ± 1.1; p < 10-4).
","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Darrason', 'Affiliation': 'Service de Pneumologie Aigue et Cancérologie Thoracique, Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France; Institut de Recherches Philosophiques de Lyon, Université Lyon 3, Lyon, France. Electronic address: marie.darrason@chu-lyon.fr.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Service de Pneumologie Aigue et Cancérologie Thoracique, Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Couraud', 'Affiliation': 'Service de Pneumologie Aigue et Cancérologie Thoracique, Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France; Plateforme Lyon Sud de Simulation en Santé (PL3S), Faculté de médecine et de maïeutique Lyon Sud, Université de Lyon, Lyon, France.'}]",Respiratory medicine and research,['10.1016/j.resmer.2021.100856']
1515,34481264,Disrupted somatosensory input alters postural control strategies during the Star Excursion Balance Test (SEBT) in healthy people.,"BACKGROUND


Chronic adaptations, including persistent sensorimotor deficits, remain in individuals with a history of ankle instability, resulting in altered postural control strategies during functional tasks such as gait, running, or landing. However, we do not know the contribution of the altered somatosensory input on postural control strategies during a dynamic balance task such as the Star Excursion Balance Test (SEBT).
RESEARCH QUESTION


The purpose of this study was to characterize postural control strategies with and without disrupted somatosensory input during a dynamic balance task in people without chronic ankle sprain.
METHODS


This study was a crossover study design. Twenty healthy young adults (10 men, 10 women; age = 23.9 ± 3.0 years, height = 174.2 ± 7.4 cm, mass = 71.2 ± 16.7 kg) performed the posteromedial reach test during the SEBT while standing on the ground and on foam. We measured the maximum reach distance (MRD); joint angles of the ankle, knee, hip, and trunk in the sagittal, frontal, and transverse planes; and position and displacement of the center of mass (COM) and center of pressure (COP) during the posteromedial reach task.
RESULTS


The MRD was shorter when standing on the foam than on the ground (p < 0.001). There was a condition by phase interaction for ankle dorsiflexion; tibia internal rotation; and trunk flexion (p < 0.001; p = 0.03; p = 0.01, respectively). The COM and COP were positioned more laterally on the foam (p < 0.001). The COM and COP anterior-posterior displacements were more anterior during the foam condition (p = 0.017).
SIGNIFICANCE


By using a foam pad to disrupt somatosensory information, participants demonstrated altered strategies to control the joint kinematics, COM, and COP, as a function of posteromedial distance. Ankle and trunk movement strategies may influence the posteromedial reach distance. This model may simulate changes that occur with chronic ankle instability.",2021,"The COM and COP anterior-posterior displacements were more anterior during the foam condition (p = 0.017).
","['people without chronic ankle sprain', 'Twenty healthy young adults (10 men, 10 women; age = 23.9 ± 3.0 years, height = 174.2 ± 7.4 cm, mass = 71.2 ± 16.7 kg) performed the posteromedial reach test during the SEBT while standing on the ground and on foam', 'healthy people']",['Star Excursion Balance Test (SEBT'],"['MRD', 'maximum reach distance (MRD); joint angles of the ankle, knee, hip, and trunk in the sagittal, frontal, and transverse planes; and position and displacement of the center of mass (COM) and center of pressure (COP', 'COM and COP anterior-posterior displacements', 'ankle dorsiflexion; tibia internal rotation; and trunk flexion', 'COM and COP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0333044', 'cui_str': 'Posterior displacement'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",20.0,0.0489528,"The COM and COP anterior-posterior displacements were more anterior during the foam condition (p = 0.017).
","[{'ForeName': 'Shojiro', 'Initials': 'S', 'LastName': 'Nozu', 'Affiliation': 'Graduate School of Comprehensive Human Sciences. University of Tsukuba, 1-1-1 Tennodai, Tsukuba City, Ibaraki, 305-8574, Japan. Electronic address: s.nozu.hw@juntendo.ac.jp.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Johnson', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, 1-252 Medical Education Building, Iowa City, IA, 52242, USA. Electronic address: kristin-a-johnson@uiowa.edu.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Takemura', 'Affiliation': 'Graduate School of Comprehensive Human Sciences. University of Tsukuba, 1-1-1 Tennodai, Tsukuba City, Ibaraki, 305-8574, Japan. Electronic address: takemura.masahiro.gw@u.tsukuba.ac.jp.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Shields', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, 1-252 Medical Education Building, Iowa City, IA, 52242, USA. Electronic address: richard-shields@uiowa.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2021.08.023']
1516,34482050,Neuromuscular training after concussion to improve motor and psychosocial outcomes: A feasibility trial.,"OBJECTIVE


To determine the feasibility of an 8-week neuromuscular training program initiated upon return-to-play clearance following concussion.
DESIGN


Feasibility trial.
SETTING


A single sports medicine center.
PARTICIPANTS


We approached n = 54 patients; n = 32 agreed to participate (59%). N = 27 participants returned for their second visit at return-to-play clearance (84%) and were randomized to neuromuscular training (n = 13) or standard-of-care (n = 14).
MAIN OUTCOME MEASURES


Participants completed three assessments: within 14 days post-concussion, immediately after return-to-play clearance, and 8-weeks following return-to-play clearance. The intervention aimed to achieve positive neuromuscular adaptations and occurred 2x/week for 8 weeks under supervision.
RESULTS


N = 2 participants randomized to the intervention elected not to participate, both due to schedule conflicts (e.g., time required to meet with the study team). Participants began the intervention an average of 11 days after return-to-play clearance, the majority (91%) completed >75% of training sessions, and training sessions lasted an average of 18.2 ± 4.8 min. One participant stopped the intervention after 7 training sessions due to time availability.
CONCLUSION


It is feasible to initiate a neuromuscular training program for most athletes shortly after returning to play following concussion. Clinicians and researchers may consider this approach to mitigate the increased musculoskeletal injury risk for concussion patients returning to sports.",2021,"Participants began the intervention an average of 11 days after return-to-play clearance, the majority (91%) completed >75% of training sessions, and training sessions lasted an average of 18.2 ± 4.8 min.","['We approached n\xa0=\xa054 patients; n\xa0=\xa032 agreed to participate (59', '27 participants returned for their second visit at return-to-play clearance (84%) and were randomized to', 'A single sports medicine center']","['Neuromuscular training', 'neuromuscular training (n\xa0=\xa013) or standard-of-care', 'neuromuscular training program']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],2.0,0.0344189,"Participants began the intervention an average of 11 days after return-to-play clearance, the majority (91%) completed >75% of training sessions, and training sessions lasted an average of 18.2 ± 4.8 min.","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Howell', 'Affiliation': ""Sports Medicine Center, Children's Hospital Colorado, Aurora, CO, USA; Department of Orthopedics, University of Colorado School of Medicine, Aurora, CO, USA. Electronic address: David.Howell@CUAnschutz.edu.""}, {'ForeName': 'Corrine N', 'Initials': 'CN', 'LastName': 'Seehusen', 'Affiliation': ""Sports Medicine Center, Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Walker', 'Affiliation': ""Sports Medicine Center, Children's Hospital Colorado, Aurora, CO, USA; Department of Orthopedics, University of Colorado School of Medicine, Aurora, CO, USA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Reinking', 'Affiliation': ""Sports Medicine Center, Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Wilson', 'Affiliation': ""Sports Medicine Center, Children's Hospital Colorado, Aurora, CO, USA; Department of Orthopedics, University of Colorado School of Medicine, Aurora, CO, USA; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, USA.""}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.05.014']
1517,34491227,An Adaptive Intervention Trial Design for Finding the Optimal Integrated Strategies for Malaria Control and Elimination in Africa: A Model Simulation Study.,"There are a number of available and emerging malaria intervention tools that require innovative trial designs to find the optimal combinations at given epidemiologic settings. We simulated intervention strategies based on adaptive interventions, which included long-lasting insecticidal nets (LLINs), piperonyl butoxide-treated LLINs (PBO-LLINs), indoor residual spraying (IRS), and long-lasting microbial larviciding (LLML). The aims were to determine if PBO-LLINs or LLIN+IRS combination is more effective for initial interventions than LLINs and to identify the most effective intervention. We used a clustered, randomized adaptive trial design with malaria infection prevalence (MIP) as the outcome variable. The results indicate that during the initial stage of interventions, compared with regular LLINs, PBO-LLINs (relative reduction [RR]: 29.3%) and LLIN plus IRS with alternative-insecticide (RR: 26.8%) significantly reduced MIP. In the subsequent interventions, adding alternative insecticide IRS (RR: 23.8%) or LLML (RR: 31.2%) to existing PBO-LLIN was effective in further reducing MIP. During the next stage of interventions, adding LLML on top of PBO-LLIN+IRS (with alternative insecticides) had a significant impact on MIP (RR: 39.2%). However, adding IRS (with alternative insecticides) on top of PBO-LLIN+LLML did not significantly reduce MIP (11.6%). Overall, in clusters initiated with PBO-LLIN, adding LLML would be the most effective strategy in reducing MIP; in clusters initiated with LLIN+IRS, replacing LLIN+IRS with PBO-LLIN and LLML would be the most effective in reducing MIP. This study provides a new pathway for informing the optimal integrated malaria vector interventions, and the new strategy can be tested in field trials.",2021,"In the subsequent interventions, adding alternative insecticide IRS (RR: 23.8%) or LLML (RR: 31.2%) to existing PBO-LLIN was effective in further reducing MIP.",['Malaria Control and Elimination in Africa'],"['adaptive interventions, which included long-lasting insecticidal nets (LLINs), piperonyl butoxide-treated LLINs (PBO-LLINs), indoor residual spraying (IRS), and long-lasting microbial larviciding (LLML', 'LLML', 'LLIN+IRS combination']","['MIP', 'regular LLINs, PBO-LLINs']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}]",,0.035442,"In the subsequent interventions, adding alternative insecticide IRS (RR: 23.8%) or LLML (RR: 31.2%) to existing PBO-LLIN was effective in further reducing MIP.","[{'ForeName': 'Guofa', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Ming-Chieh', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Daibin', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hemming-Schroeder', 'Affiliation': ''}, {'ForeName': 'Guiyun', 'Initials': 'G', 'LastName': 'Yan', 'Affiliation': ''}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0254']
1518,34495393,Metformin in Pregnancy for Women with Type 2 Diabetes: a Review.,"PURPOSE OF REVIEW


To review the current evidence for the use of metformin in pregnancy for women with type 2 diabetes.
RECENT FINDINGS


A large, multicenter, double-blind randomized controlled trial found that women with type 2 diabetes in pregnancy treated with metformin as an adjunct to insulin therapy had less gestational weight gain, insulin requirements, caesarian sections, macrosomia, and neonatal adiposity, but more neonates were small for gestational age (SGA) compared with insulin alone. It is unclear if the higher number of SGA infants are a direct result of metformin exposure or mediated through other effects such as less gestational weight gain and improved glycemic control. Additional follow-up studies of offspring exposed to metformin in utero are required. Metformin may be a useful adjunctive treatment for women with type 2 diabetes in pregnancy to help meet glycemic targets if there are no concerns for or indications of SGA.",2021,Metformin may be a useful adjunctive treatment for women with type 2 diabetes in pregnancy to help meet glycemic targets if there are no concerns for or indications of SGA.,"['women with type 2 diabetes in pregnancy', 'women with type 2 diabetes', 'Women with Type 2 Diabetes', 'women with type 2 diabetes in pregnancy treated with']","['insulin therapy', 'metformin', 'insulin alone', 'Metformin']","['gestational weight gain and improved glycemic control', 'gestational weight gain, insulin requirements, caesarian sections, macrosomia, and neonatal adiposity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.195199,Metformin may be a useful adjunctive treatment for women with type 2 diabetes in pregnancy to help meet glycemic targets if there are no concerns for or indications of SGA.,"[{'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Benham', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Donovan', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. jennifer.yamamoto@umanitoba.ca.'}]",Current diabetes reports,['10.1007/s11892-021-01409-0']
1519,34496275,Intranasal oxytocin reduces attentional bias to food stimuli.,"Attentional biases to food-related stimuli have been demonstrated in response to hunger as well as during restrained eating. Such biases are often associated with obesity, but healthy-weight individuals who do not self-report hunger have also demonstrated attentional biases to stimuli signalling food using laboratory-based cognitive tasks. Levels of the anorectic neuropeptide oxytocin are elevated by food intake and, when administered intranasally, oxytocin inhibits food intake in the laboratory. To investigate whether oxytocin can affect appetite via an action on attentional processes, 40 adults (29 women; mean age 24.0 years old) self-administered 24 IU of oxytocin or placebo intranasally. Forty minutes after administration, participants ate a small snack to maintain alertness and ameliorate deprivation-induced hunger before starting a computerized dot-probe attentional bias task that presented 180 trials of paired visual stimuli comprising neutral, food, social and/or romantic images (500 ms presentation time). Reaction times to probe stimuli that appeared after the offset of the visual images indicated a significant attentional bias to food pictures after placebo; this effect was significantly attenuated by oxytocin, p < .001. The effect of oxytocin on attentional bias to the food pictures was not altered by the type of stimulus paired with the food image, and was independent of BMI, age, sex, self-rated eating behaviour, and self-reported parental bonding; however, the effect was modulated by self-reported food cravings and trait stress. The findings support and extend previous work which has suggested that oxytocin can counteract attentional biases to food-related stimuli in a sample with anorexia by demonstrating the same effect for the first time in a cohort who do not have an eating disorder.",2021,"The effect of oxytocin on attentional bias to the food pictures was not altered by the type of stimulus paired with the food image, and was independent of BMI, age, sex, self-rated eating behaviour, and self-reported parental bonding; however, the effect was modulated by self-reported food cravings and trait stress.",['40 adults (29 women; mean age 24.0 years old) self-administered 24 IU of'],"['Intranasal oxytocin', 'small snack to maintain alertness and ameliorate deprivation-induced hunger before starting a computerized dot-probe attentional bias task that presented 180 trials of paired visual stimuli comprising neutral, food, social and/or romantic images', 'oxytocin or placebo', 'oxytocin', 'placebo']","['attentional bias to food pictures', 'attentional bias to the food pictures']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",,0.0662482,"The effect of oxytocin on attentional bias to the food pictures was not altered by the type of stimulus paired with the food image, and was independent of BMI, age, sex, self-rated eating behaviour, and self-reported parental bonding; however, the effect was modulated by self-reported food cravings and trait stress.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Burmester', 'Affiliation': 'Faculty of Medicine, Department of Brain Sciences, Imperial College London, 7N11c Commonwealth Building Hammersmith Hospital, 72 Du Road, London W12 0NN, UK. Electronic address: v.burmester@imperial.ac.uk.'}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Butler', 'Affiliation': 'Department of Psychology, School of Law, Social and Behavioural Sciences, Kingston University, Penrhyn Road, Kingston Upon Thames, Surrey KT1 2EE, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Terry', 'Affiliation': 'Department of Psychology, School of Law, Social and Behavioural Sciences, Kingston University, Penrhyn Road, Kingston Upon Thames, Surrey KT1 2EE, UK.'}]",Appetite,['10.1016/j.appet.2021.105684']
1520,34496274,"Should you ""picture"" this? Effects of picture-taking features of food diary apps on memory, liking, and wanting.","Picture-taking functions are commonly available features in food diaries and other mobile applications that may influence how we think about the very food we consume. Because memories of food (Higgs & Donohoe, 2011) and the act of recording food consumption (Turk et al., 2013) have been shown to influence desire for and consumption of food, this paper investigated the effects of using the picture-taking feature of a food diary app on liking, wanting, and memory of food. Using a simple food diary app with a picture-taking feature loaded onto iPads, participants took part in a lab experiment where they either did or did not use the picture-taking feature of the app as they ate a snack. To capture the changes in liking and wanting that naturally occur as more food is consumed, participants were also randomly assigned to receive either larger or smaller portions of the snack. The results indicate that picture-taking while eating is associated with greater wanting of the food following consumption. Furthermore, for smaller portions of food, taking pictures during consumption is associated with greater liking of the food. However, taking pictures in the smaller portion size condition was also associated with less detailed recall of food's sensory properties.",2021,"However, taking pictures in the smaller portion size condition was also associated with less detailed recall of food's sensory properties.",[],[],"['memory, liking, and wanting']",[],[],"[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}]",,0.0808361,"However, taking pictures in the smaller portion size condition was also associated with less detailed recall of food's sensory properties.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bayliss', 'Affiliation': 'Department of Communication Arts, College of Arts and Humanities, Georgia Southern University, USA. Electronic address: lbayliss@georgiasouthern.edu.'}, {'ForeName': 'Linwan', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'School of Journalism and Mass Communications, College of Information and Communications, University of South Carolina, USA.'}]",Appetite,['10.1016/j.appet.2021.105682']
1521,34499672,Maternal PCOS status and metformin in pregnancy: Steroid hormones in 5-10 years old children from the PregMet randomized controlled study.,"OBJECTIVE


Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with potential effects on offspring both genetically and through altered intrauterine environment. Metformin, which ameliorate hormonal disturbances in non-pregnant women with PCOS is increasingly used in pregnancy. It passes the placenta, and the evidence on potential consequences for offspring endocrine development is scarce. We explore the potential effects of maternal PCOS status and intrauterine metformin exposure on offspring steroid hormone levels.
DESIGN


This is a follow-up study of 5-10 years old children from the PregMet-study-a randomized controlled trial comparing metformin (2000 mg/day) to placebo during PCOS pregnancies. Of the 255 children invited, 117 (46%) were included.
METHODS


There was no intervention in this follow-up study. Outcomes were serum levels of androstenedione, testosterone, SHBG, cortisol, 17-hydroxyprogesterone, 11-deoxycortisol and calculated free testosterone converted to gender-and age adjusted z-scores from a Norwegian reference population. These were compared in i) placebo-exposed children versus children from the reference population (z-score zero) by the deviation in z-score by one-sample t-tests and ii) metformin versus placebo-exposed children by two-sample t-tests. Holm-Bonferroni adjustments were performed to account for multiple endpoints.
RESULTS


Girls of mothers with PCOS (n = 30) had higher mean z-scores of androstenedione (0.73 (95% confidence interval (CI) 0.41 to 1.06), p<0.0001), testosterone (0.76 (0.51 to 1.00), p<0.0001), and free testosterone (0.99 (0.67 to 1.32), p<0.0001) than the reference population. Metformin-exposed boys (n = 31) tended to have higher 11-deoxycortisol z-score than placebo-exposed boys (n = 24) (mean difference 0.65 (95% CI 0.14-1.17), p = 0.014).
CONCLUSION


Maternal PCOS status was associated with elevated androgens in 5- to 10-year-old daughters, which might indicate earlier maturation and increased risk of developing PCOS. An impact of metformin in pregnancy on steroidogenesis in children born to mothers with PCOS cannot be excluded. Our findings need confirmation in studies that include participants that have entered puberty.",2021,"Metformin-exposed boys (n = 31) tended to have higher 11-deoxycortisol z-score than placebo-exposed boys (n = 24) (mean difference 0.65 (95% CI 0.14-1.17), p = 0.014).
","['children born to mothers with PCOS', '5-10 years old children', '5-10 years old children from the PregMet-study', 'Polycystic ovary syndrome (PCOS', 'Girls of mothers with PCOS (n = 30', '255 children invited, 117 (46%) were included', 'non-pregnant women with PCOS']","['placebo', 'metformin', 'Metformin', 'metformin versus placebo']","['testosterone', 'hormonal disturbances', 'mean z-scores of androstenedione', 'serum levels of androstenedione, testosterone, SHBG, cortisol, 17-hydroxyprogesterone, 11-deoxycortisol and calculated free testosterone converted to gender-and age adjusted z-scores', '11-deoxycortisol z-score', 'free testosterone', 'Maternal PCOS status']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0045010', 'cui_str': '17-alpha-Hydroxyprogesterone'}, {'cui': 'C0010139', 'cui_str': '11-deoxycortisol'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",255.0,0.317511,"Metformin-exposed boys (n = 31) tended to have higher 11-deoxycortisol z-score than placebo-exposed boys (n = 24) (mean difference 0.65 (95% CI 0.14-1.17), p = 0.014).
","[{'ForeName': 'Liv Guro Engen', 'Initials': 'LGE', 'LastName': 'Hanem', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Madsen', 'Affiliation': 'Hormone Laboratory, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jørn V', 'Initials': 'JV', 'LastName': 'Sagen', 'Affiliation': 'Hormone Laboratory, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Mellgren', 'Affiliation': 'Hormone Laboratory, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Petur Benedikt', 'Initials': 'PB', 'LastName': 'Juliusson', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Sven Magnus', 'Initials': 'SM', 'LastName': 'Carlsen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Vanky', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Rønnaug', 'Initials': 'R', 'LastName': 'Ødegård', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}]",PloS one,['10.1371/journal.pone.0257186']
1522,34506512,Multilevel factor analysis of flipped classroom in dental education: A 3-year randomized controlled trial.,"PURPOSE


Previous studies have rarely attempted to test the confounding factors that may affect learning outcomes of the flipped classroom. The purpose of this study was to assess how flipped classrooms affect the acquisition of knowledge in clinical dental education based on multilevel factor analysis.
METHOD


The authors conducted a 3-year (2017, 2018, and 2019) randomized controlled trial in a series of introductory prosthodontics courses in dental education. A total of 137 participants were randomly assigned to flipped classroom (n = 70, 51%) or lecture (n = 67, 49%) formats. The flipped group was instructed to self-learn knowledge-based content through online preparation materials, including videos and text, while the lecture group was given text only. Both groups were provided with the same study content and opportunities for different styles of learning. The session attendance rate and number of times the materials were accessed were monitored. Individual and team readiness assurance tests (IRAT/TRAT) were conducted to evaluate knowledge acquisition. A multilevel linear regression analysis was conducted on both instructional styles (flipped vs. lecture) as an intervention factor, and confounding factors that could affect the outcomes were implemented.
RESULTS


The average number of online accesses was 2.5 times per session in the flipped group and 1.2 in the lecture group, with a significant difference (p < .05). The average IRAT score was significantly higher in the flipped than in the lecture group (effect size [ES] 0.58, p < .001). The number of online accesses was significantly and positively correlated with IRAT scores (0.6 [0.4, 0.8]). The instructional style was significantly and positively correlated with TRAT scores (coefficient [95% confidence interval]: 4.6 [2.0, 7.3]), but it was not correlated with IRAT (4.3 [-0.45, 9.0]).
CONCLUSIONS


The flipped classroom was more effective than the lecture format regarding knowledge acquisition; however, the decisive factor was not the instructional style but the number of individual learning occasions. The employment of the flipped classroom was the decisive factor for team-based learning outcomes.",2021,"The average IRAT score was significantly higher in the flipped than in the lecture group (effect size [ES] 0.58, p < .001).","['A total of 137 participants', 'dental education', '3-year (2017, 2018, and 2019) randomized controlled trial in a series of introductory prosthodontics courses in dental education']","['Individual and team readiness assurance tests (IRAT/TRAT', 'flipped classroom']","['average IRAT score', 'number of online accesses', 'average number of online accesses', 'session attendance rate and number of times the materials', 'IRAT scores', 'TRAT scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0013627', 'cui_str': 'Dental Education'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0033590', 'cui_str': 'Prosthodontics'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0520510', 'cui_str': 'Material'}]",137.0,0.0670937,"The average IRAT score was significantly higher in the flipped than in the lecture group (effect size [ES] 0.58, p < .001).","[{'ForeName': 'Zuo', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'Eiko Yoshida', 'Initials': 'EY', 'LastName': 'Kohno', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Fueki', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Inamochi', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Takada', 'Affiliation': 'Department of Professional Development in Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Wakabayashi', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0257208']
1523,34504196,Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection.,"The objective of this randomized controlled trial (RCT) was to assess the impact of rifaximin on the course of liver function, liver regeneration and volumetric recovery in patients undergoing major hepatectomy. The ARROW trial was an investigator initiated, single-center, open-label, phase 3 RCT with two parallel treatment groups, conducted at our hepatobiliary center from 03/2016 to 07/2020. Patients undergoing major hepatectomy were eligible and randomly assigned 1:1 to receive oral rifaximin (550 mg twice daily for 7-10 or 14-21 days in case of portal vein embolization preoperatively and 7 days postoperatively) versus no intervention. Primary endpoint was the relative increase in postoperative liver function measured by LiMAx from postoperative day (POD) 4 to 7. Secondary endpoint were the course of liver function and liver volume during the study period as well as postoperative morbidity and mortality. Between 2016 and 2020, 45 patients were randomized and 35 patients (16 individuals in the rifaximin and 19 individuals in the control group) were eligible for per-protocol analysis. The study was prematurely terminated following interim analysis, due to the unlikelihood of reaching a significant primary endpoint. The median relative increase in liver function from POD 4 to POD 7 was 27% in the rifaximin group and 41% in the control group (p = 0.399). Further, no significant difference was found in terms of any other endpoints of functional liver- and volume regeneration or perioperative surgical complications following the application of rifaximin versus no intervention. Perioperative application of rifaximin has no effect on functional or volumetric regeneration after major hepatectomy (NCT02555293; EudraCT 2013-004644-28).",2021,Perioperative application of rifaximin has no effect on functional or volumetric regeneration after major hepatectomy (NCT02555293; EudraCT 2013-004644-28).,"['patients undergoing major hepatectomy', 'Patients undergoing major hepatectomy', 'Between 2016 and 2020, 45 patients were randomized and 35 patients (16 individuals in the rifaximin and 19 individuals in the control group) were eligible for per-protocol analysis']","['oral rifaximin', 'rifaximin', 'portal vein embolization preoperatively and 7\xa0days postoperatively) versus no intervention']","['functional liver- and volume regeneration or perioperative surgical complications', 'liver function, liver regeneration and volumetric recovery', 'course of liver function and liver volume during the study period as well as postoperative morbidity and mortality', 'postoperative liver function', 'liver function', 'functional or volumetric regeneration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C0578122', 'cui_str': 'Embolization of portal vein'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0023907', 'cui_str': 'Liver Regeneration'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",45.0,0.0951554,Perioperative application of rifaximin has no effect on functional or volumetric regeneration after major hepatectomy (NCT02555293; EudraCT 2013-004644-28).,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bednarsch', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Czigany', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Sven H', 'Initials': 'SH', 'LastName': 'Loosen', 'Affiliation': 'Department of Medicine III, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Heij', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Ruckgaber', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Maes', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Jan-Pit', 'Initials': 'JP', 'LastName': 'Krause', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Reen', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Toteva', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Vosdellen', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Bruners', 'Affiliation': 'Department of Radiology, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Sven Arke', 'Initials': 'SA', 'LastName': 'Lang', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Tom Florian', 'Initials': 'TF', 'LastName': 'Ulmer', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Roderburg', 'Affiliation': 'Department of Medicine III, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Luedde', 'Affiliation': 'Department of Medicine III, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Ulf Peter', 'Initials': 'UP', 'LastName': 'Neumann', 'Affiliation': 'Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany. uneumann@ukaachen.de.'}]",Scientific reports,['10.1038/s41598-021-97442-w']
1524,34517392,"Comparison of the Conventional Downward and Modified Upward Laryngeal Handshake Techniques to Identify the Cricothyroid Membrane: A Randomized, Comparative Study.","BACKGROUND


Accurate identification of the cricothyroid membrane is crucial for successful cricothyroidotomy. The aim of this study was to compare the conventional downward and modified upward laryngeal handshake techniques in terms of accuracy to identify the cricothyroid membrane in nonobese female patients.
METHODS


In 198 anesthetized female patients, the cricothyroid membrane was identified by either the conventional downward laryngeal handshake technique (n = 99) or the modified upward laryngeal handshake technique (n = 99). According to the conventional downward laryngeal handshake technique, the cricothyroid membrane was identified by palpating the neck downward from the greater cornu of the hyoid bone, thyroid laminae, and cricoid cartilage. According to the modified upward laryngeal handshake technique, the cricothyroid membrane was located by moving up from the sternal notch. The primary outcome was the accuracy of identifying the cricothyroid membrane. Secondary outcomes included the accuracy of midline identification and time taken to locate what participants believed to be the cricothyroid membrane. The primary and secondary outcomes according to the technique were analyzed using generalized estimating equations.
RESULTS


The cricothyroid membrane could be identified more accurately by the modified upward laryngeal handshake technique than by the conventional downward technique (84% vs 56%, respectively; odds ratio [OR], 4.36; 95% confidence interval [CI], 2.13-8.93; P < .001). Identification of the midline was also more accurate by the modified laryngeal handshake than by the conventional technique (96% vs 83%, respectively; OR, 4.98; 95% CI, 1.65-15.01; P = .004). The time taken to identify the cricothyroid membrane was not different between the conventional and modified techniques (20.2 [16.2-26.6] seconds vs 19.0 [14.5-26.4] seconds, respectively; P = .83).
CONCLUSIONS


The modified upward laryngeal handshake technique that involved tracing the trachea and laryngeal structures upward from the sternal notch was more accurate in identifying the cricothyroid membrane than the conventional downward technique in anesthetized female patients.",2021,"Identification of the midline was also more accurate by the modified laryngeal handshake than by the conventional technique (96% vs 83%, respectively; OR, 4.98; 95% CI, 1.65-15.01; P = .004).","['anesthetized female patients', 'Cricothyroid Membrane', 'nonobese female patients', '198 anesthetized female patients, the cricothyroid membrane was identified by either the conventional downward laryngeal handshake technique (n = 99) or the modified upward laryngeal handshake technique (n = 99']",['conventional downward and modified upward laryngeal handshake techniques'],"['accuracy of identifying the cricothyroid membrane', 'accuracy of midline identification and time taken to locate what participants believed to be the cricothyroid membrane', 'time taken to identify the cricothyroid membrane']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458560', 'cui_str': 'Cricothyroid membrane'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205104', 'cui_str': 'Down'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1282911', 'cui_str': 'Upward'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205104', 'cui_str': 'Down'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1282911', 'cui_str': 'Upward'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0458560', 'cui_str': 'Cricothyroid membrane'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",198.0,0.0888023,"Identification of the midline was also more accurate by the modified laryngeal handshake than by the conventional technique (96% vs 83%, respectively; OR, 4.98; 95% CI, 1.65-15.01; P = .004).","[{'ForeName': 'Jee-Eun', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': 'From the Department of Anesthesiology & Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hyerim', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology & Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Dongwook', 'Initials': 'D', 'LastName': 'Won', 'Affiliation': 'From the Department of Anesthesiology & Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Man', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'From the Department of Anesthesiology & Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Kyong', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology & Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Seong-Won', 'Initials': 'SW', 'LastName': 'Min', 'Affiliation': 'From the Department of Anesthesiology & Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Young', 'Initials': 'JY', 'LastName': 'Hwang', 'Affiliation': 'From the Department of Anesthesiology & Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005744']
1525,34516956,The effects of acute exercise on appetite and energy intake in men and women.,"PURPOSE


To compare energy intake (EI) and appetite regulation responses between men and women following acute bouts of aerobic (AEx), resistance exercise (REx), and a sedentary control (CON).
METHODS


Men and women (n = 24; 50% male) with overweight/obesity, matched on age (32.3 ± 2 vs. 36.8 ± 2 yrs, p = 0.14) and BMI (28.1 ± 1.2 vs 29.0 ± 1.5 kg/m2, p = 0.64) completed 3 conditions: 1) AEx (65-70% of age-predicted maximum heart rate for 45 min); 2) REx (1-set to failure on 12 exercises); and 3) CON. Each condition was initiated in the post-prandial state (35 min following consumption of a standardized breakfast). Appetite (visual analog scale for hunger, satiety, and prospective food consumption [PFC]) and hormones (ghrelin, PYY, and GLP-1) were measured in the fasted state and every 30 min post-prandially for 3 h. Post-exercise ad libitum EI at the lunch meal was also measured.
RESULTS


Men reported higher levels of hunger compared to women across all study conditions (AEx: Men: 7815.00 ± 368.3; Women: 5428.50 ± 440.0 mm x 180 min; p = 0.025; REx: Men: 7110.00 ± 548.4; Women: 6086.25 ± 482.9 mm x 180 min; p = 0.427; CON: Men: 8315.00 ± 429.8; Women: 5311.25 ± 543.1 mm x 180 min; p = 0.021) and consumed a greater absolute caloric load than women at the ad libitum lunch meal (AEx: Men: 1021.6 ± 105.4; Women: 851.7 ± 70.5 kcals; p = 0.20; REx: Men: 1114.7 ± 104.0; Women: 867.7 ± 76.4 kcals; p = 0.07; CON: Men: 1087.0 ± 98.8; Women: 800.5 ± 102.3 kcals; p = 0.06). However, when adjusted for relative energy needs, there was no difference in relative ad libitum EI observed between men and women. No differences in Area Under the Curve for Satiety, PFC, ghrelin, PYY, and GLP-1 were noted between men and women following acute exercise (all p > 0.05).
CONCLUSIONS


These data suggest that women report lower ratings of appetite following an acute bout of exercise or sedentary time when compared to men, yet have similar relative EI. Future work is needed to examine whether sex-based differences in appetite regulation and EI are present with chronic exercise of differing modalities.",2021,"No differences in Area Under the Curve for Satiety, PFC, ghrelin, PYY, and GLP-1 were noted between men and women following acute exercise (all p>0.05).
","['Men: 8315.00 ± 429.8; Women: 5311.25 ± 543.1 mm x 180 min; p= 0.021) and consumed a greater absolute caloric load than women at the ad libitum lunch meal (AEx: Men: 1021.6 ± 105.4; Women: 851.7 ± 70.5 kcals; p=0.20; REx: Men: 1114.7 ± 104.0; Women: 867.7 ± 76.4 kcals; p=0.07; CON: Men: 1087.0 ± 98.8; Women: 800.5 ± 102.3 kcals; p= 0.06', 'men and women following acute bouts of aerobic (AEx), resistance exercise (REx), and a sedentary control (CON', 'Men and women (n=24; 50% male) with overweight/obesity matched on age (32.3±2 vs. 36.8±2 yrs, p=0.14) and BMI (28.1±1.2 vs 29.0±1.5 kg/m2, p=0.64) completed\xa03\xa0conditions: 1) AEx (65-70% of age-predicted maximum heart rate for 45 min); 2) REx (1-set to failure on 12 exercises); and 3) CON', 'Men and Women', 'Men: 7815.00 ± 368.3; Women: 5428.50 ± 440.0 mm x 180 min; p=0.025; REx: Men: 7110.00 ± 548.4; Women: 6086.25 ± 482.9 mm x 180 min; p=0.427; CON']",['Acute Exercise'],"['Appetite and Energy Intake', 'Appetite (visual analog scale for hunger, satiety, and prospective food consumption [PFC]) and hormones (ghrelin, PYY, and GLP-1', 'levels of hunger', 'energy intake (EI) and appetite regulation responses', 'Area Under the Curve for Satiety, PFC, ghrelin, PYY, and GLP-1']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003622', 'cui_str': 'Appetite control'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]",,0.155756,"No differences in Area Under the Curve for Satiety, PFC, ghrelin, PYY, and GLP-1 were noted between men and women following acute exercise (all p>0.05).
","[{'ForeName': 'Selene Y', 'Initials': 'SY', 'LastName': 'Tobin', 'Affiliation': 'Department of Health and Kinesiology, College of Health, University of Utah, 250 S 1850 E., Salt Lake City, UT 84112, United States.'}, {'ForeName': 'Marc-Andre', 'Initials': 'MA', 'LastName': 'Cornier', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States; Anschutz Health & Wellness Center at the University of Colorado, Anschutz Medical Campus, Aurora, Colorado, United States; Rocky Mountain Regional Veterans Administration, Aurora, Colorado, United States.'}, {'ForeName': 'Mollie H', 'Initials': 'MH', 'LastName': 'White', 'Affiliation': 'Anschutz Health & Wellness Center at the University of Colorado, Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Allison K', 'Initials': 'AK', 'LastName': 'Hild', 'Affiliation': 'Anschutz Health & Wellness Center at the University of Colorado, Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Simonsen', 'Affiliation': 'College of Nursing, University of Utah, Salt Lake City, United States.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States; Rocky Mountain Regional Veterans Administration, Aurora, Colorado, United States; Division of Geriatric Medicine, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Halliday', 'Affiliation': 'Department of Health and Kinesiology, College of Health, University of Utah, 250 S 1850 E., Salt Lake City, UT 84112, United States; Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States. Electronic address: tanya.halliday@utah.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2021.113562']
1526,34516760,The Relationships Between Reduced Alcohol Use and Decreased Burnout Following Mindfulness-Based Resilience Training in Law Enforcement Officers.,"Objective:  This study is a secondary analysis of data collected in an earlier clinical trial of mindfulness-based resilience training (MBRT) (ClinicalTrials.gov registration number 02521454), where the MBRT condition demonstrated a significant reduction in self-reported burnout and trend-level reductions in alcohol use in law enforcement officers (LEOs). Given that MBRT is not designed to be a substance use intervention and does not contain explicit substance-related content, this study sought to clarify these findings by exploring whether improved burnout mediates reduced alcohol use.  Method:  Participants ( n  = 61) were sworn LEOs (89% male, 85% White, 8% Hispanic/Latinx) recruited from departments in a large urban metro area of the northwestern United States, and were randomized to either MBRT ( n  = 31) or no intervention control group ( n  = 30) during the trial.  Results:  MBRT group assignment predicted reduced burnout ( b  = 0.43, standard error [SE] = 0.14,  p  = 0.004), which subsequently predicted reduced alcohol use ( b  = 1.69, SE = 0.81,  p  = 0.045). Results suggest that reduced alcohol use was indirectly related to a reduction in burnout post-MBRT.  Conclusion:  Given that MBRT does not explicitly address substance use, these findings were interpreted to suggest that officers in the training acquired a new set of coping skills to deal with the operational and organizational stressors of police work.",2021,"Results:  MBRT group assignment predicted reduced burnout ( b  = 0.43, standard error [SE] = 0.14,  p  = 0.004), which subsequently predicted reduced alcohol use ( b  = 1.69, SE = 0.81,  p  = 0.045).","['Method:  Participants ( n \u2009=\u200961) were sworn LEOs (89% male, 85% White, 8% Hispanic/Latinx) recruited from departments in a large urban metro area of the northwestern United States']","['MBRT', 'mindfulness-based resilience training (MBRT', 'no intervention control group']",[],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0233730', 'cui_str': 'Swearing'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0165186,"Results:  MBRT group assignment predicted reduced burnout ( b  = 0.43, standard error [SE] = 0.14,  p  = 0.004), which subsequently predicted reduced alcohol use ( b  = 1.69, SE = 0.81,  p  = 0.045).","[{'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Rehder', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Eddy', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Kaplan', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Bergman', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christopher', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2021.0052']
1527,34516591,"Effects of full-body mirror exposure on eating pathology, body image and emotional states: Comparison between positive and negative verbalization.","Mirror exposure (ME) is an effective technique to improve body image. However, evidence on the underlying mechanisms and the optimal verbalization instruction during ME is lacking. Therefore, this experimental study analyzed mechanisms of ME and therapeutic outcomes by comparing positive (PV) and negative (NV) full-body verbalization. N = 73 healthy females were randomized to a PV or an NV condition. PV participants verbalized positively while NV participants verbalized negatively about their whole body. Each participant underwent three standardized ME sessions. Before and after each ME session, positive affect, negative affect and body satisfaction were assessed. Before the first and after the third ME, participants completed questionnaires on cognitive-affective and behavioral aspects of body image, eating pathology and self-esteem. Regarding within-ME changes, the results indicate that positive affect and body satisfaction decreased while negative affect increased in the NV group but not in the PV group. In contrast, regarding between-ME changes, decreased negative affect as well as positive affect and increased body satisfaction were observed in both groups. However, eating pathology remained stable, whereas body-checking behavior increased and the PV condition was followed by higher levels of self-esteem compared to the NV condition. These findings suggest that both PV and NV improve negative affect and body satisfaction between-ME, and thus seem to be effective ME instructions. Given that NV led to increased negative affect within-ME and did not influence self-esteem, PV might represent the favorable instruction during ME for body-satisfied women.",2021,"However, eating pathology remained stable, whereas body-checking behavior increased and the PV condition was followed by higher levels of self-esteem compared to the NV condition.",['N = 73 healthy females'],"['full-body mirror exposure', 'Mirror exposure (ME']","['eating pathology, body image and emotional states', 'positive affect, negative affect and body satisfaction', 'body satisfaction', 'cognitive-affective and behavioral aspects of body image, eating pathology and self-esteem', 'body-checking behavior']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}]",73.0,0.00304814,"However, eating pathology remained stable, whereas body-checking behavior increased and the PV condition was followed by higher levels of self-esteem compared to the NV condition.","[{'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Tanck', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Osnabrück University, Osnabrück, Germany.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Hartmann', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Osnabrück University, Osnabrück, Germany.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Svaldi', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Tübingen University, Tübingen, Germany.'}, {'ForeName': 'Silja', 'Initials': 'S', 'LastName': 'Vocks', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Osnabrück University, Osnabrück, Germany.'}]",PloS one,['10.1371/journal.pone.0257303']
1528,34519717,Effect of Aerobic Exercise-induced Weight Loss on the Components of Daily Energy Expenditure.,"INTRODUCTION


Exercise usually results in less weight loss than expected. This suggests increased energy intake and/or deceased expenditure counteract the energy deficit induced by exercise. The aim of this study was to evaluate changes in components of daily energy expenditure (doubly labeled water and room calorimetry) after 24 wk of exercise training with two doses of aerobic exercise.
METHODS


This was an ancillary study in 42 (29 women, 13 men) sedentary, middle-age (47.8 ± 12.5 yr) individuals with obesity (35 ± 3.7 kg·m-2) enrolled in the Examination of Mechanisms of Exercise-induced Weight Compensation study. Subjects were randomized to three groups: healthy living control group (n = 13), aerobic exercise that expended 8 kcal·kg-1 of body weight per week (8 KKW, n = 14), or aerobic exercise that expended 20 kcal per kilogram of weight per week (20 KKW, n = 15). Total daily energy expenditure (TDEE) was measured in free-living condition by doubly labeled water and in sedentary conditions in a metabolic chamber over 24 h (24EE). Energy intake was calculated over 14 d from TDEE before and after the intervention using the intake-balance method.
RESULTS


Significant weight loss occurred with 20 KKW (-2.1 ± 0.7 kg, P = 0.04) but was only half of expected. In the 20 KKW group free-living TDEE increased by ~4% (P = 0.03), which is attributed to the increased exercise energy expenditure (P = 0.001), while 24EE in the chamber decreased by ~4% (P = 0.04). Aerobic exercise at 8 KKW did not induce weight change, and there was no significant change in any component of EE. There was no significant change in energy intake for any group (P = 0.53).
CONCLUSIONS


Structured aerobic exercise at a dose of 20 KKW produced less weight loss than expected possibly due to behavioral adaptations leading to reduced 24EE in a metabolic chamber without any change in energy intake.",2021,"In the 20 KKW group free-living TDEE increased by ~4% (P = 0.03), which is attributed to the increased exercise energy expenditure (P = 0.001), while 24EE in the chamber decreased by ~4% (P = 0.04).","['42 (29 women, 13 men) sedentary, middle-age (47.8 ± 12.5 yr) individuals with obesity (35 ± 3.7 kg·m-2) enrolled in the Examination of Mechanisms of Exercise-induced Weight Compensation study']","['daily energy expenditure (doubly labeled water and room calorimetry', 'Aerobic Exercise-induced Weight Loss', 'aerobic exercise', 'Structured aerobic exercise', 'healthy living control group (n = 13), aerobic exercise']","['exercise energy expenditure', 'energy intake', 'weight change', 'weight loss', 'free-living TDEE', 'Total daily energy expenditure (TDEE', 'component of EE', 'Energy intake']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0006779', 'cui_str': 'Calorimetry'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.00964689,"In the 20 KKW group free-living TDEE increased by ~4% (P = 0.03), which is attributed to the increased exercise energy expenditure (P = 0.001), while 24EE in the chamber decreased by ~4% (P = 0.04).","[{'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Broskey', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Burton', 'Affiliation': ''}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Church', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': ''}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002689']
1529,34487947,Immediate functional progression program in adolescent athletes with a spondylolysis.,"OBJECTIVE


To assess the preliminary evidence for the efficacy and safety of an immediate functional progression program to treat adolescent athletes with an active spondylolysis.
DESIGN


Prospective single-arm trial.
SETTING


Hospital-based sports medicine and physical therapy clinic.
PARTICIPANTS


Twelve adolescent athletes (14.2 ± 2 years, 25% female) with an active spondylolysis.
MAIN OUTCOME MEASURES


Clinical outcomes included time out of sport, Micheli Functional Scale (Function and Pain) and adverse reactions. Clinical outcomes were assessed at baseline, 1 month, 3 months and 6 months. Magnetic resonance imaging was performed at baseline and 3 months to confirm diagnosis and assess healing of lesion.
RESULTS


Eleven participants (92%) fully returned to sport in a median time of 2.5 months (75 days; interquartile range 55 days, 85 days). All participants demonstrated marked improvements in pain and function by the end of the program. One participant (8%) had an adverse reaction during care with a significant recurrence of LBP and had not returned to sport by 6 months. Magnetic resonance imaging demonstrated improvement of the spondylolytic lesion in all but one participant.
CONCLUSION


The immediate functional progression program appears a viable method for treating active spondylolysis and warrants future research.",2021,"RESULTS


Eleven participants (92%) fully returned to sport in a median time of 2.5 months (75 days; interquartile range 55 days, 85 days).","['adolescent athletes with a spondylolysis', 'Twelve adolescent athletes (14.2\xa0±\xa02 years, 25% female) with an active spondylolysis', 'adolescent athletes with an active spondylolysis', 'Hospital-based sports medicine and physical therapy clinic']","['Magnetic resonance imaging', 'Immediate functional progression program', 'immediate functional progression program']","['efficacy and safety', 'adverse reaction', 'healing of lesion', 'spondylolytic lesion', 'time out of sport, Micheli Functional Scale (Function and Pain) and adverse reactions', 'pain and function']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0038018', 'cui_str': 'Spondylolysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",12.0,0.19845,"RESULTS


Eleven participants (92%) fully returned to sport in a median time of 2.5 months (75 days; interquartile range 55 days, 85 days).","[{'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Selhorst', 'Affiliation': ""Sports and Orthopedic Physical Therapy, Nationwide Children's Hospital, Columbus, OH, USA. Electronic address: Mitchell.Selhorst@Nationwidechildrens.org.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacDonald', 'Affiliation': ""Division of Sports Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Martin', 'Affiliation': ""Department of Radiology, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rodenberg', 'Affiliation': ""Division of Sports Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Ramkumar', 'Initials': 'R', 'LastName': 'Krishnamurthy', 'Affiliation': ""Department of Radiology, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Reno', 'Initials': 'R', 'LastName': 'Ravindran', 'Affiliation': ""Division of Sports Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Fischer', 'Affiliation': ""Division of Sports Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.08.009']
1530,34492426,Comparison between postauricular steroid injection and intratympanic steroid perfusion for refractory severe and profound sudden sensorineural hearing loss.,"BACKGROUND


To analyze the clinical efficacy of intratympanic steroid perfusion (ISP) and postauricular steroid injection (PSI) for refractory severe and profound sudden sensorineural hearing loss (SSNHL).
METHODS


SSNHL patients who failed a conventional treatment with severe to profound hearing loss [pure tone average (PTA, 0.25-8 kHz) > 60 dB] were treated with ISP or PSI plus antioxidant and neurotrophin for 10 consecutive days. Antioxidant and neurotrophin were administrated either intravenously and/or orally. All patients were assigned into the ISP group or the PSI group and followed up for more than three months. The changes in PTA, effective rate and side effects were analyzed in the two groups.
RESULTS


Similar hearing improvements and effective rates were observed in the two groups. However, a slightly better efficacy was observed in the PSI group compared to the ISP group. Patients with shorter intervals from onset to treatment had significantly more hearing improvements. The route of antioxidant and neurotrophin administration had no impact on treatment effects.
CONCLUSION


Both ISP and PSI could be used as salvage treatments for refractory SSNHL. These salvage treatments should be started as soon as possible once SSNHL patients fail a conventional treatment.",2021,Patients with shorter intervals from onset to treatment had significantly more hearing improvements.,"['SSNHL patients who failed a conventional treatment with severe to profound hearing loss [pure tone average (PTA, 0.25-8\xa0kHz)\xa0', '60\xa0dB']","['intratympanic steroid perfusion (ISP) and postauricular steroid injection (PSI', 'Antioxidant and neurotrophin', 'postauricular steroid injection and intratympanic steroid perfusion', 'ISP or PSI plus antioxidant and neurotrophin', 'antioxidant and neurotrophin', 'ISP']","['changes in PTA, effective rate and side effects', 'hearing improvements and effective rates', 'hearing improvements']","[{'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0556965', 'cui_str': 'kHz'}]","[{'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0442168', 'cui_str': 'Postauricular'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",,0.0525055,Patients with shorter intervals from onset to treatment had significantly more hearing improvements.,"[{'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University, Nanjing, China; Department of Otorhinolaryngology-Head and Neck Surgery, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian, China.""}, {'ForeName': 'Ziwen', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jianbing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Yancheng City Dafeng People's Hospital, Yancheng, China.""}, {'ForeName': 'Yuanling', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, The Affiliated Hospital of Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Jiangsu Provincial Key Medical Discipline, Nanjing, China.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University, Nanjing, China; Department of Otorhinolaryngology-Head and Neck Surgery, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian, China.""}, {'ForeName': 'Zhibiao', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University, Nanjing, China; Department of Otorhinolaryngology-Head and Neck Surgery, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian, China.""}, {'ForeName': 'Zhengqun', 'Initials': 'Z', 'LastName': 'Bai', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Yancheng City Dafeng People's Hospital, Yancheng, China. Electronic address: dafengbzq@163.com.""}, {'ForeName': 'Wandong', 'Initials': 'W', 'LastName': 'She', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University, Nanjing, China; Department of Otorhinolaryngology-Head and Neck Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Jiangsu Provincial Key Medical Discipline, Nanjing, China. Electronic address: shewandong@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.103189']
1531,34500081,"Milrinone is better choice for controlled low central venous pressure during hepatectomy: A randomized, controlled trial comparing with nitroglycerin.","BACKGROUND


To explore the feasibility and effectiveness of controlled low central venous pressure(CLCVP)induced by milrinone during hepatectomy, and its influence on perioperative hemodynamics, blood loss and patients' recovery, comparing with the traditional method by nitroglycerin.
METHODS


52 patients who underwent elective open hepatectomy were enrolled in the study and randomly divided into two groups: milrinone (M) group and nitroglycerin (NG) group. Milrinone was infused with the rate of 0.5 μg/kg/min in group M, while nitroglycerin was given 0.2-0.5 μg/kg/min in group NG to maintain CVP≤ 5 mmHg during liver resection. The demographic variables, data of the operative procedure and intraoperative hemodynamics were recorded. The postoperative recovery profiles and pre- and post-operative haematological markers of vital organs were also collected and compared.
RESULTS


1. The blood loss of group M, no matter during liver resection or in the whole procedure, was both less than that of group NG (P < 0.05), so did the hemoglobin detected by blood gas analysis (P < 0.05). Meanwhile, time of hepatectomy and hepatic hilum occlusion were shorter in group M (P < 0.05). 2. Compared with the NG group, cardiac index (CI) and stroke volume index (SVR) were higher in group M in the operation. The norepinephrine dosage necessary in the operation was of no difference in two groups (P > 0.05). 3. Drainage indwelling time and postoperative hospital stay of group M were shorter than that of group NG (P < 0.05). Most of the blood biomarkers increased on postoperative day (POD)-1, and returned to the preoperative level on POD-7 without inter-group difference (P > 0.05). Brain natriuretic peptide precursor (Pro-BNP) in group M was higher than NG group on POD-1 (P < 0.05), and the statistical difference disappeared on POD-7.
CONCLUSION


Milrinone can effectively maintain a controlled low central venous pressure during hepatectomy. Compared with nitroglycerin, milrinone can reduce the amount of blood loss, with the benefit of better manifestation of hemodynamics and enhanced postoperative recovery.",2021,"Brain natriuretic peptide precursor (Pro-BNP) in group M was higher than NG group on POD-1 (P < 0.05), and the statistical difference disappeared on POD-7.
",['52 patients who underwent elective open hepatectomy'],"['milrinone', 'nitroglycerin', 'milrinone (M) group and nitroglycerin (NG', 'Milrinone', 'nitroglycerin, milrinone']","['blood loss', 'Meanwhile, time of hepatectomy and hepatic hilum occlusion', 'Drainage indwelling time and postoperative hospital stay', 'cardiac index (CI) and stroke volume index (SVR', 'Brain natriuretic peptide precursor (Pro-BNP', 'postoperative recovery profiles and pre- and post-operative haematological markers of vital organs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0128513', 'cui_str': 'Milrinone'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0442732', 'cui_str': 'Vital'}]",52.0,0.046005,"Brain natriuretic peptide precursor (Pro-BNP) in group M was higher than NG group on POD-1 (P < 0.05), and the statistical difference disappeared on POD-7.
","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Sun Yat-sen University, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'The First Affiliated Hospital of Sun Yat-sen University, China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Sun Yat-sen University, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'The First Affiliated Hospital of Sun Yat-sen University, China.'}, {'ForeName': 'Binghan', 'Initials': 'B', 'LastName': 'Hai', 'Affiliation': 'The First Affiliated Hospital of Sun Yat-sen University, China.'}, {'ForeName': 'Xiongqing', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'The First Affiliated Hospital of Sun Yat-sen University, China. Electronic address: Huangxq@mail.sysu.edu.cn.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106080']
1532,34499961,The modulation of salience and central executive networks by acute stress in healthy males: An EEG microstates study.,"EEG microstate analysis involves the examination of topographies of the scalp potential fields to indicate the temporal dynamics of resting-state networks on a millisecond time scale, through which we can investigate the subsecond brain dynamics of stress in individuals. The present study implemented the EEG microstate method to explore the temporal dynamic changes of the large-scale brain networks induced by acute stress. The participants (n = 51) were randomly exposed to a stress condition (n = 25) (induced by Trier Social Stress Test, TSST) or a control condition (n = 26). Two 4-min blocks of resting EEG data were recorded before and after the stress/control test to reflect the stress effect on temporal dynamics of EEG microstates. The results showed that the stress group had larger occurrences and coverage of microstate class C during the post-test session than during the pre-test session. This pattern was reversed in the control group. Further, the microstate class C showed positive correlations with negative affect and perceived stress levels following acute stress. The transition probability between the microstates C and D was larger during the post-test session than during the pre-test session in the stress group, but not different in the control group. In addition, the microstate pairs C and D were positively correlated with negative affect and perceived stress levels. The proportion and sequence of EEG microstates class C and D reflected deviations of salience and executive functions following acute stress. We further proposed that the coordination between salience and executive functions was promoted by acute stress.",2021,The results showed that the stress group had larger occurrences and coverage of microstate class C during the post-test session than during the pre-test session.,"['healthy males', 'participants (n\u202f=\u202f51']","['stress condition (n\u202f=\u202f25) (induced by Trier Social Stress Test, TSST) or a control condition']","['larger occurrences and coverage of microstate class C', 'negative affect and perceived stress levels']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",51.0,0.0152708,The results showed that the stress group had larger occurrences and coverage of microstate class C during the post-test session than during the pre-test session.,"[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'School of Preschool & Special Education, Kunming University, Kunming, China.'}, {'ForeName': 'Quanshan', 'Initials': 'Q', 'LastName': 'Long', 'Affiliation': 'Faculty of Education, Yunnan Normal University, Kunming, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'School of Linguistics and Arts, Collaborative Innovation Center for Language Competence, Jiang Su Normal University, Xuzhou, China.'}, {'ForeName': 'Yilu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China; Nanchong Senior High School.'}, {'ForeName': 'Antao', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: xscat@swu.edu.cn.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Huo', 'Affiliation': 'Jeonju University, Child & Special Needs Education School, Jeonju, South Korea.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Jeonju University, Education School, Jeonju, South Korea.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Preschool & Special Education, Kunming University, Kunming, China.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2021.09.001']
1533,34499874,"Gemcitabine with or without ramucirumab as second-line treatment for malignant pleural mesothelioma (RAMES): a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


There is a preclinical rationale for inhibiting angiogenesis in mesothelioma. We aimed to assess the efficacy and safety of the anti-VEGFR-2 antibody ramucirumab combined with gemcitabine in patients with pretreated malignant pleural mesothelioma.
METHODS


RAMES was a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial done at 26 hospitals in Italy. Eligible patients were aged 18 years or older, had Eastern Cooperative Oncology Group performance status 0-2, and histologically proven malignant pleural mesothelioma progressing during or after first-line treatment with pemetrexed plus platinum. Patients were randomly assigned (1:1) to receive intravenous gemcitabine 1000 mg/m 2  on days 1 and 8 every 3 weeks plus either intravenous placebo (gemcitabine plus placebo group) or ramucirumab 10 mg/kg (gemcitabine plus ramucirumab group) on day 1 every 3 weeks, until tumour progression or unacceptable toxicity. Central randomisation was done according to a minimisation algorithm method, associated with a random element using the following stratification factors: ECOG performance status, age, histology, and first-line time-to-progression. The primary endpoint was overall survival, measured from the date of randomisation to the date of death from any cause. Efficacy analyses were assessed in all patients who had been correctly randomised and received their allocated treatment, and safety analyses were assessed in all patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT03560973, and with EudraCT, 2016-001132-36.
FINDINGS


Between Dec 22, 2016, and July 30, 2018, of 165 patients enrolled 161 were correctly assigned and received either gemcitabine plus placebo (n=81) or gemcitabine plus ramucirumab (n=80). At database lock (March 8, 2020), with a median follow-up of 21·9 months (IQR 17·7-28·5), overall survival was longer in the ramucirumab group (HR 0·71, 70% CI 0·59-0·85; p=0·028). Median overall survival was 13·8 months (70% CI 12·7-14·4) in the gemcitabine plus ramucirumab group and 7·5 months (6·9-8·9) in the gemcitabine plus placebo group. Grade 3-4 treatment-related adverse events were reported in 35 (44%) of 80 patients in the gemcitabine plus ramucirumab group and 24 (30%) of 81 in the gemcitabine plus placebo group. The most common treatment-related grade 3-4 adverse events were neutropenia (16 [20%] for gemcitabine plus ramucirumab vs ten [12%] for gemcitabine plus placebo) and hypertension (five [6%] vs none). Treatment-related serious adverse events were reported in five (6%) in the gemcitabine plus ramucirumab group and in four (5%) patients in the gemcitabine plus placebo group; the most common was thromboembolism (three [4%] for gemcitabine plus ramucirumab vs two [2%] for gemcitabine plus placebo). There were no treatment-related deaths.
INTERPRETATION


Ramucirumab plus gemcitabine significantly improved overall survival after first-line standard chemotherapy, with a favourable safety profile. This combination could be a new option in this setting.
FUNDING


Eli Lilly Italy.
TRANSLATION


For the Italian translation of the abstract see Supplementary Materials section.",2021,Median overall survival was 13·8 months (70% CI 12·7-14·4) in the gemcitabine plus ramucirumab group and 7·5 months (6·9-8·9) in the gemcitabine plus placebo group.,"['26 hospitals\u2009in Italy', 'Eligible patients were aged 18 years or older, had Eastern Cooperative Oncology Group performance status 0-2, and histologically proven malignant pleural mesothelioma progressing during or after first-line treatment with', 'Between Dec 22, 2016, and July 30, 2018', 'patients with pretreated malignant pleural mesothelioma', '165 patients enrolled 161', 'malignant pleural mesothelioma (RAMES']","['placebo', 'pemetrexed plus platinum', 'gemcitabine', 'gemcitabine plus placebo', 'ramucirumab 10 mg/kg (gemcitabine plus ramucirumab', 'placebo (gemcitabine plus placebo', 'gemcitabine plus ramucirumab', 'anti-VEGFR-2 antibody ramucirumab combined with gemcitabine', 'intravenous gemcitabine', 'Gemcitabine with or without ramucirumab']","['neutropenia', 'adverse events', 'thromboembolism', 'serious adverse events', 'efficacy and safety', 'Median overall survival', 'overall survival']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C4319555', 'cui_str': '165'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0378796', 'cui_str': 'KDR Tyrosine Kinase'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",161.0,0.277597,Median overall survival was 13·8 months (70% CI 12·7-14·4) in the gemcitabine plus ramucirumab group and 7·5 months (6·9-8·9) in the gemcitabine plus placebo group.,"[{'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Pinto', 'Affiliation': 'Medical Oncology Unit, Clinical Cancer Centre, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Paolo Andrea', 'Initials': 'PA', 'LastName': 'Zucali', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Milan, Italy; Department of Oncology, IRCCS Humanitas Research Hospital, Milan, Italy. Electronic address: paolo.zucali@hunimed.eu.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pagano', 'Affiliation': 'Medical Oncology Unit, Clinical Cancer Centre, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Grosso', 'Affiliation': 'Mesothelioma Unit, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy; Infrastruttura Ricerca Formazione e Innovazione, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Pasello', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy; Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padua, Italy.'}, {'ForeName': 'Marina Chiara', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Thoracic Oncology Unit, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tiseo', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy; Medical Oncology Unit, University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Soto Parra', 'Affiliation': 'Medical Oncology Unit, AOU Policlinico Vittorio Emanuele, Catania, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Grossi', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore, Milan, Italy; Medical Oncology Unit, University of Insubria, Varese, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Cappuzzo', 'Affiliation': 'Medical Oncology Unit, IRCCS Istituto Nazionale Tumori Regina Elena, Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': 'Thoracic Oncology Division, Istituto Europeo di Oncologia IRCCS, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pedrazzoli', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Department of Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bonomi', 'Affiliation': 'Department of Oncology, Cliniche Humanitas Gavazzeni, Bergamo, Italy; Department of Oncology, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Gianoncelli', 'Affiliation': 'Department of Oncology, Cliniche Humanitas Gavazzeni, Bergamo, Italy; Department of Oncology, Ospedale San Paolo, Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Perrino', 'Affiliation': 'Department of Oncology, IRCCS Humanitas Research Hospital, Milan, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Milan, Italy; Department of Oncology, IRCCS Humanitas Research Hospital, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zanelli', 'Affiliation': 'Medical Oncology Unit, Clinical Cancer Centre, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Candida', 'Initials': 'C', 'LastName': 'Bonelli', 'Affiliation': 'Medical Oncology Unit, Clinical Cancer Centre, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Maconi', 'Affiliation': 'Infrastruttura Ricerca Formazione e Innovazione, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Frega', 'Affiliation': 'Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padua, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Gervasi', 'Affiliation': 'Medical Oncology Unit, Clinical Cancer Centre, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Giovanni Luca', 'Initials': 'GL', 'LastName': 'Ceresoli', 'Affiliation': 'Department of Oncology, Cliniche Humanitas Gavazzeni, Bergamo, Italy.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00404-6']
1534,34507261,Educational program on sexuality and contraceptive methods in nursing degree students.,"BACKGROUND


Previous educational programs about sexuality and contraceptive methods are delivered through vertical teaching methodology and use an increase in knowledge level as an indicator of effectiveness; however, attitudes towards contraceptive use are not addressed.
OBJECTIVES


This study aimed to evaluate the effect of a peer-educational intervention to improve knowledge level and attitudes regarding contraceptive methods in university students.
DESIGN


A pre-post quasi-experimental study.
SETTINGS


Young university students from a Spanish university.
PARTICIPANTS


131 students in their second year of the Nursing degree program.
METHODS


An intervention consisting of two 3-hour sessions was conducted. The first session introduced the main aspects of contraceptive methods and was conducted by the teacher. The second session began with student presentations about contraceptive methods, followed by clinical simulations of a family planning service that the students had to implement and solve.
RESULTS


There was a 71.43% improvement in the knowledge level scale score and a 2.17% improvement in the attitudes towards the use of contraceptive methods; both were statistically significant (p < 0.001). For 11 of the 15 items in the knowledge scale, a significantly higher proportion of success was found after the intervention.
CONCLUSION


Peer-educational intervention was effective in improving knowledge level and attitudes about contraceptive methods.",2021,There was a 71.43% improvement in the knowledge level scale score and a 2.17% improvement in the attitudes towards the use of contraceptive methods; both were statistically significant (p < 0.001).,"['nursing degree students', 'Young university students from a Spanish university', 'university students', '131 students in their second year of the Nursing degree program']","['Peer-educational intervention', 'Educational program', 'peer-educational intervention']","['knowledge level scale score', 'knowledge level and attitudes regarding contraceptive methods']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}]",131.0,0.0313725,There was a 71.43% improvement in the knowledge level scale score and a 2.17% improvement in the attitudes towards the use of contraceptive methods; both were statistically significant (p < 0.001).,"[{'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Sanz-Martos', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, Building B3, office 214, Campus Las Lagunillas, 23071 Jaén, Spain. Electronic address: ssanz@ujaen.es.'}, {'ForeName': 'Isabel M', 'Initials': 'IM', 'LastName': 'López-Medina', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, Building B3, office 265, Campus Las Lagunillas, 23071 Jaén, Spain. Electronic address: imlopez@ujaen.es.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Álvarez-García', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, Building B3, office 241, Campus Las Lagunillas, 23071 Jaén, Spain. Electronic address: cagarcia@ujaen.es.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Álvarez-Nieto', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, Building B3, office 243, Campus Las Lagunillas, 23071 Jaén, Spain. Electronic address: calvarez@ujaen.es.'}]",Nurse education today,['10.1016/j.nedt.2021.105114']
1535,34507245,Simulated nature and positive body image: A comparison of the impact of exposure to images of blue and green spaces.,"Previous research has shown that exposure to simulated natural environments, such as still images and film, promotes more positive state body image. However, this body of work has not distinguished between different types of natural environment, with the distinction between blue and green spaces being notable. Here, we asked a sample of 168 university students from the United Kingdom to complete a measure of state body appreciation before and after being randomly assigned to one of three groups in which they viewed images of blue spaces, green spaces, or built environments, respectively. A mixed analysis of variance showed that exposure to images of the natural environments, but not the built environments, significantly elevated state body appreciation. In addition, exposure to images of blue spaces had a stronger effect on state body appreciation than exposure to images of green spaces. These results replicate previous work showing that exposure to simulated natural environments promotes more positive state body image, but additionally shows that blue spaces may be more effective than green spaces. Implications of the present findings for the development of imagery-based interventions aimed at promoting healthier body image are discussed.",2021,"A mixed analysis of variance showed that exposure to images of the natural environments, but not the built environments, significantly elevated state body appreciation.",['168 university students from the United Kingdom to complete a measure of state body appreciation before'],['Simulated nature and positive body image'],[],"[{'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",[],,0.0221738,"A mixed analysis of variance showed that exposure to images of the natural environments, but not the built environments, significantly elevated state body appreciation.","[{'ForeName': 'Nat', 'Initials': 'N', 'LastName': 'Rygal', 'Affiliation': 'School of Psychology and Sport Science, Anglia Ruskin University, Cambridge, United Kingdom.'}, {'ForeName': 'Viren', 'Initials': 'V', 'LastName': 'Swami', 'Affiliation': 'School of Psychology and Sport Science, Anglia Ruskin University, Cambridge, United Kingdom; Centre for Psychological Medicine, Perdana University, Kuala Lumpur, Malaysia. Electronic address: viren.swami@aru.ac.uk.'}]",Body image,['10.1016/j.bodyim.2021.08.004']
1536,34508694,Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms.,"BACKGROUND


Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized.
METHODS


Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary.
RESULTS


Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P <0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 -14.2, P <0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months (P <0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P <0.001).
CONCLUSIONS


In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms.
TRIAL REGISTRATION


ClinicalTrials.gov number: NCT01803438.",2021,"Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint.","['107 patients', 'Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy']","['Initial Rhythm Control with Cryoballoon Ablation versus Drug Therapy', 'Cryoballoon ablation (CBA']","['AFEQT summary, subscale and treatment satisfaction scores', 'EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires', 'Quality of Life and Symptoms', 'incidence rate of symptomatic palpitations', 'AFEQT summary score', 'EHRA class', 'Symptomatic palpitations', 'Symptoms and QoL', 'SF-36 physical and mental component scores']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",107.0,0.0835865,"Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint.","[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Pavlovic', 'Affiliation': 'Sestre Milosrdnice University Hospital Centre, Zagreb, Croatia; University Hospital Dubrava, Zagreb, Croatia. Electronic address: nikolap12@yahoo.com.'}, {'ForeName': 'Gian-Battista', 'Initials': 'GB', 'LastName': 'Chierchia', 'Affiliation': 'Heart Rhythm Management Centre, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Vedran', 'Initials': 'V', 'LastName': 'Velagic', 'Affiliation': 'University Hospital Centre Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Jean Sylvain', 'Initials': 'JS', 'LastName': 'Hermida', 'Affiliation': ""Centre Hospitalier Universitaire d'Amiens-Picardie, France.""}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Healey', 'Affiliation': 'Monash Health, Clayton, Australia.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Arena', 'Affiliation': 'Ospedale Apuane, Massa Carrara, Italy.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Badenco', 'Affiliation': 'AP-HP Sorbonne Université, ICAN Institute, Hospital Pitié-Salpétrière, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Cardiac Neuro- and Electrophysiology Research Consortium, EVK Düsseldorf, University Heart Center, Hamburg, Germany.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Haukeland University Hospital, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Iacopino', 'Affiliation': 'GVM Care&Research, Maria Cecilia Hospital, Cotignola, Italy.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Anselme', 'Affiliation': 'CHU de Rouen, Rouen, France.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Dekker', 'Affiliation': 'Catharina Ziekenhuis, Eindhoven, The Netherlands.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Scazzuso', 'Affiliation': 'Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Packer', 'Affiliation': ""Mayo Clinic Hospital - St. Mary's Campus, Rochester, Minnesota, USA.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'de Asmundis', 'Affiliation': 'Heart Rhythm Management Centre, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Heinz-Friedrich', 'Initials': 'HF', 'LastName': 'Pitschner', 'Affiliation': 'Kerckhoff Heart Center, Bad Nauheim, Germany.'}, {'ForeName': 'Fabio Di', 'Initials': 'FD', 'LastName': 'Piazza', 'Affiliation': 'Medtronic, Core Clinical Solutions, Study and Scientific Solutions, Rome, Italy.'}, {'ForeName': 'Rachelle E', 'Initials': 'RE', 'LastName': 'Kaplon', 'Affiliation': 'Medtronic, Cardiac Ablation Solutions, Minneapolis, Minnesota.'}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Kuniss', 'Affiliation': 'Kerckhoff Heart Center, Bad Nauheim, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2021.08.007']
1537,34508693,Inhibition of p38 MAP kinase in patients with ST-elevation myocardial infarction - findings from the LATITUDE-TIMI 60 trial.,"BACKGROUND


p38 mitogen activated kinase (MAPK) mediates the response to pro-inflammatory cytokines following myocardial infarction (MI) and is inhibited by losmapimod.
METHODS


LATITUDE-TIMI 60 (ClinicalTrials.gov NCT02145468) randomized patients with MI to losmapimod or placebo for 12 weeks (24 weeks total follow-up). In this pre-specified analysis, we examined outcomes based on MI type [ST-segment elevation MI (STEMI) (865, 25%) and non-STEMI (2624, 75%)].
RESULTS


In patients with STEMI, inflammation, measured by hs-CRP, was significantly attenuated with losmapimod at 48 hours (P <0.001) and week 12 (P = 0.01). Losmapimod lowered NT-proBNP in patients with STEMI at 48 hours (P = 0.04) and week 12 (P = 0.02). The effects of losmapimod on CV death (CVD), MI, or severe recurrent ischemia requiring urgent coronary artery revascularization at 24 weeks [MACE] differed in patients with STEMI (7.0% vs 10.8%; HR 0.65, 95%CI 0.41 - 1.03; P= 0.06) and NSTEMI (11.4% vs 8.5%; HR 1.30, 95%CI 1.02 - 1.66; P = 0.04; p[int] = 0.009). CVD or HHF among patients with STEMI were 5.6% (losmapimod) and 8.3% (placebo) (HR 0.66; 95%CI 0.40 - 1.11; P = 0.12) and in NSTEMI were 4.8% (losmapimod) and 4.4% (placebo) (HR 1.09; 95%CI 0.76 - 1.56) in patients with NSTEMI.
CONCLUSIONS


Patients with STEMI treated with losmapimod had an attenuated inflammatory response. Our collective findings raise the hypothesis that mitigating the inflammatory response may result in different outcomes in patients with STEMI and NSTEMI. While the difference in outcomes is exploratory, these findings do support separate examination of patients with STEMI and NSTEMI and increased emphasis on heart failure in future investigation of modulators of inflammation in MI.",2021,Losmapimod lowered NT-proBNP in patients with STEMI at 48 hours (p=0.04) and week 12 (p=0.02).,"['LATITUDE-TIMI 60 (ClinicalTrials.gov', 'Patients with ST-Elevation Myocardial Infarction - Findings from the LATITUDE TIMI 60 Trial', 'patients with STEMI and NSTEMI']","['p38 MAP Kinase', 'MI to losmapimod or placebo', 'p38 mitogen activated kinase (MAPK']","['CV death (CVD), MI, or severe recurrent ischemia requiring urgent coronary artery revascularization', 'CVD or HHF', 'MI type [ST-segment elevation MI (STEMI', 'inflammatory response', 'Losmapimod lowered NT-proBNP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C4255010', 'cui_str': 'Non-ST-Elevation Myocardial Infarction'}]","[{'cui': 'C0257535', 'cui_str': 'CSAID-Binding Protein'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0076899', 'cui_str': 'transactivator protein p38(tax)'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",,0.320193,Losmapimod lowered NT-proBNP in patients with STEMI at 48 hours (p=0.04) and week 12 (p=0.02).,"[{'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Cavender', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': ""O'Donoghue"", 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts; TIMI Study Group, Boston, Massachusetts.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aylward', 'Affiliation': 'South Australian Health and Medical Research Institute, Flinders University and Medical Centre, Adelaide, Australia.'}, {'ForeName': 'Keith Aa', 'Initials': 'KA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland.'}, {'ForeName': 'Ruchira X', 'Initials': 'RX', 'LastName': 'Glaser', 'Affiliation': 'Metabolic Pathways and Cardiovascular Unit, Research and Development, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'Jeong-Gun', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts; TIMI Study Group, Boston, Massachusetts.""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Sendon', 'Affiliation': 'University Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Ph Gabriele', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Université Paris-Diderot, Paris, France, Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Université Paris-Diderot, Paris, France; National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts; TIMI Study Group, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts; TIMI Study Group, Boston, Massachusetts. Electronic address: dmorrow@partners.org.""}]",American heart journal,['10.1016/j.ahj.2021.08.022']
1538,34510454,Impact of preoperative transcatheter rectal arterial chemoembolization with concurrent chemoradiotherapy on surgery and prognosis of patients with locally advanced rectal cancer.,"BACKGROUND AND OBJECTIVES


To analyze and evaluate the impact of preoperative transcatheter rectal arterial chemoembolization (TRACE) with concurrent chemoradiotherapy on surgery and prognosis of locally advanced rectal cancer (LARC).
METHODS


A total of 118 patients with LARC were enrolled in this nonrandomized prospective study. They were assigned into the experimental group receiving preoperative TRACE with concurrent chemoradiotherapy (TRACE-CRT group, N = 60) and the control group receiving only neoadjuvant chemoradiotherapy (CRT group, N = 58). All patients underwent surgery after their preoperative treatments.
RESULTS


All patients successfully completed the surgical operation. No significant differences were found in sphincter preservation rate and R0 resection rate between TRACE-CRT group and CRT group (p > 0.05). No significant differences were found between the two groups in terms of the perioperative indicators and postoperative complications except mean operation time (165.8 vs. 196.6 min, p < 0.001). Local recurrence occurred in 8 and 5 patients, respectively (p > 0.05). Distant metastasis occurred in 5 and 11 patients, respectively (p < 0.05).
CONCLUSIONS


Adding TRACE in the preoperative standard treatment for LARC did not increase perioperative complications. In addition, it has the potential advantage of preventing distant metastasis. It is worthy of further application and promotion in clinical practice.",2021,No significant differences were found in sphincter preservation rate and R0 resection rate between TRACE-CRT group and CRT group (p > 0.05).,"['patients with locally advanced rectal cancer', 'locally advanced rectal cancer (LARC', '118 patients with LARC']","['preoperative TRACE with concurrent chemoradiotherapy (TRACE-CRT group, N\u2009=\u200960) and the control group receiving only neoadjuvant chemoradiotherapy (CRT', 'preoperative transcatheter rectal arterial chemoembolization with concurrent chemoradiotherapy', 'preoperative transcatheter rectal arterial chemoembolization (TRACE) with concurrent chemoradiotherapy']","['sphincter preservation rate and R0 resection rate', 'Distant metastasis', 'Local recurrence', 'perioperative indicators and postoperative complications except mean operation time', 'perioperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",118.0,0.0704869,No significant differences were found in sphincter preservation rate and R0 resection rate between TRACE-CRT group and CRT group (p > 0.05).,"[{'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Meng', 'Affiliation': 'Department of Gastrointestinal Surgery, Yongchuan Hospital, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Cancer Center, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Department of General Surgery, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Cancer Center, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Cancer Center, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jian', 'Affiliation': 'Department of Cancer Center, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Department of Cancer Center, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Cancer Center, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Chunxue', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Surgery, Yongchuan Hospital, Chongqing Medical University, Chongqing, China.'}]",Journal of surgical oncology,['10.1002/jso.26673']
1539,34510104,Heterogeneity of Treatment Effects Among Patients With Type 2 Diabetes and Elevated Body Mass Index in a Study Comparing Group Medical Visits Focused on Weight Management and Medication Intensification.,"BACKGROUND


Illuminating heterogeneity of treatment effect (HTE) within trials is important for identifying target populations for implementation.
OBJECTIVE


The aim of this study was to examine HTE in a trial of group medical visits (GMVs) for patients with type 2 diabetes and elevated body mass index.
RESEARCH DESIGN AND MEASURES


Participants (n=263) were randomized to GMV-based medication management plus low carbohydrate diet-focused weight management (WM/GMV; n=127) or GMV-based medication management alone (GMV; n=136) for diabetes control. We used QUalitative INteraction Trees, a tree-based clustering method, to identify subgroups with greater improvement in hemoglobin A1c (HbA1c) and weight from either WM/GMV or GMV. Subgroup predictors included 32 baseline demographic, clinical, and psychosocial factors. Internal validation was conducted to estimate bias in the range of mean outcome differences between arms.
RESULTS


QUalitative INteraction Trees analyses indicated that for patients who had not previously attempted weight loss, WM/GMV resulted in better glycemic control than GMV (mean difference in HbA1c improvement=1.48%). For patients who had previously attempted weight loss and had lower cholesterol and blood urea nitrogen, GMV was better than WM/GMV (mean difference in HbA1c improvement=1.51%). No treatment-subgroup effects were identified for weight. Internal validation resulted in moderate corrections in mean HbA1c differences between arms; however, differences remained in the clinically significant range.
CONCLUSION


This work represents a novel step toward targeting care approaches for patients to maximize benefit based on individual patient characteristics.",2021,"For patients who had previously attempted weight loss and had lower cholesterol and blood urea nitrogen, GMV was better than WM/GMV (mean difference in HbA1c improvement=1.51%).","['patients with type 2 diabetes and elevated body mass index', 'Participants (n=263']",['GMV-based medication management plus low carbohydrate diet-focused weight management (WM/GMV; n=127) or GMV-based medication management alone (GMV; n=136) for diabetes control'],"['weight loss', 'cholesterol and blood urea nitrogen, GMV', 'hemoglobin A1c (HbA1c) and weight from either WM/GMV or GMV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",263.0,0.0376951,"For patients who had previously attempted weight loss and had lower cholesterol and blood urea nitrogen, GMV was better than WM/GMV (mean difference in HbA1c improvement=1.51%).","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kobe', 'Affiliation': 'Duke University School of Medicine.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Jeffreys', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Duke University School of Medicine.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Zervakis', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}, {'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'William S Middleton Memorial Veterans Hospital.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Duke University School of Medicine.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}]",Medical care,['10.1097/MLR.0000000000001642']
1540,34508882,A randomized pilot study using calcitriol in hospitalized COVID-19 patients.,"The systemic illness associated with SARS-CoV-2 infection results in hospitalization rate of 380.3 hospitalizations per 100,000 population, overwhelming health care systems. Vitamin D regulates expression of approximately 11,000 genes spanning many physiologic functions that include regulation of both innate and adaptive immune function. We investigate potential benefit of calcitriol therapy given to patients hospitalized with COVID-19. This was an open label, randomized clinical trial of calcitriol or no treatment given to hospitalized adult patients with COVID-19. Subjects were randomly assigned treatment with calcitriol 0.5 μg daily for 14 days or hospital discharge; or no treatment (1:1) at time of enrollment. We enrolled 50 consecutive patients, 25 per trial arm. The change in peripheral arterial oxygen saturation to the inspired fraction of oxygen (SaO2/FIO2 ratio) was calculated on admission and discharge between the groups. The control group had an average increase of +13.2 (±127.7) on discharge and the calcitriol group had an increase of +91.04 (±119.08) (p = .0305), suggesting an improvement in oxygenation among subjects who received calcitriol. Additionally, 12 patients in the control group required oxygen supplementation on admission and 21 of them were discharged on room air. 14 subjects needed oxygen supplementation in the calcitriol group on admission while all 25 were discharged on room air. Other clinical markers showed the average length of stay was 9.24 (±9.4) in the control group compared to 5.5 (±3.9) days in the calcitriol group (p = .14). The need for ICU transfer was 8 in the control group and 5 in the calcitriol group. There were 3 deaths and 4 readmissions in the control group and 0 deaths and 2 readmissions in the calcitriol group. This pilot study illustrates improvement in oxygenation among hospitalized patients with COVID-19 treated with calcitriol and suggests the need for a larger randomized trial.",2021,There were 3 deaths and 4 readmissions in the control group and 0 deaths and 2 readmissions in the calcitriol group.,"['hospitalized adult patients with COVID-19', 'patients hospitalized with COVID-19', '14 subjects needed oxygen supplementation in the calcitriol group on admission while all 25 were discharged on room air', 'Hospitalized Patients', 'hospitalized patients with COVID-19 treated with', '50 consecutive patients, 25 per trial arm']","['Calcitriol', 'Vitamin D', 'calcitriol 0.5 mcg daily for 14 days or hospital discharge', 'calcitriol therapy', 'calcitriol', 'oxygen supplementation']","['deaths and 4 readmissions', 'peripheral arterial oxygen saturation to the inspired fraction of oxygen (SaO2/FIO2 ratio) on admission and discharge', 'average length of stay', 'ICU transfer']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",50.0,0.0601653,There were 3 deaths and 4 readmissions in the control group and 0 deaths and 2 readmissions in the calcitriol group.,"[{'ForeName': 'Yasmine M', 'Initials': 'YM', 'LastName': 'Elamir', 'Affiliation': 'Division of Endocrinology Diabetes and Bone Disease, Icahn School of Medicine at Mount Sinai Beth Israel, Mount Sinai Morningside, Mount Sinai West, United States of America.'}, {'ForeName': 'Hajira', 'Initials': 'H', 'LastName': 'Amir', 'Affiliation': 'Division of Endocrinology Diabetes and Bone Disease, Icahn School of Medicine at Mount Sinai Beth Israel, Mount Sinai Morningside, Mount Sinai West, United States of America. Electronic address: hajira.amir@gmail.com.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Division of Internal Medicine at Mount Sinai Beth Israel, United States of America.'}, {'ForeName': 'Yesha Patel', 'Initials': 'YP', 'LastName': 'Rana', 'Affiliation': 'Division of Internal Medicine at Mount Sinai Beth Israel, United States of America.'}, {'ForeName': 'Carolina Gonzalez', 'Initials': 'CG', 'LastName': 'Lopez', 'Affiliation': 'Division of Internal Medicine at Mount Sinai Beth Israel, United States of America.'}, {'ForeName': 'Natalia Viera', 'Initials': 'NV', 'LastName': 'Feliciano', 'Affiliation': 'Division of Internal Medicine at Mount Sinai Beth Israel, United States of America.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Omar', 'Affiliation': 'Division of Internal Medicine at Mount Sinai Beth Israel, United States of America.'}, {'ForeName': 'William Paul', 'Initials': 'WP', 'LastName': 'Grist', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine at St Joseph's University Medical Center, United States of America.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Via', 'Affiliation': 'Division of Endocrinology Diabetes and Bone Disease, Icahn School of Medicine at Mount Sinai Beth Israel, Mount Sinai Morningside, Mount Sinai West, United States of America.'}]",Bone,['10.1016/j.bone.2021.116175']
1541,34507235,Endoscopic inlay cartilage and perichondrium myringoplasty for repairing large perforations in teenagers.,"OBJECTIVE


This study compared the long-term graft success rates and hearing outcomes of overlay-underlay and underly cartilage myringoplasty for repairing large perforations in Teenagers.
STUDY DESIGN


prospective, randomized study.
SETTING


Tertiary referral center.
METHODS


Pediatric patients older than 12 years with chronic perforations were randomly divided into two groups:intervention group (n = 39) and control group (n = 41). The graft success rate, hearing improvement, and complications were compared between the two groups.
RESULTS


A total of 80 patients were included in this study. The graft success rate was 100% in the intervention group and 95.1% in the control group at postoperative 3 months, the difference wasn't significant (P = 0.496). Also, the graft success rate was not significantly different between the two groups at 12 months postoperatively (100.0% vs 87.8%, p = 0.073). However, the difference of graft success rate was significant between the two groups at 24 months postoperatively (97.4% vs 75.6%, p = 0.012). CT examination revealed well-pneumatized middle ears 24 months after surgery in both group. However, epithelial pearls near the umbo were seen at 31 months postoperatively in one patient in the observation group.
CONCLUSIONS


Compared to the endoscopic cartilage with perichondrium composite graft underlay technique, endoscopic perichondrial graft overlay and cartilage underlay had a better long-term graft success rate and lower rate of long-term re-perforation in teenagers. However, the graft technique had no effect on hearing outcome.",2021,"The graft success rate was 100% in the intervention group and 95.1% in the control group at postoperative 3 months, the difference wasn't significant (P = 0.496).","['teenagers', 'A total of 80 patients were included in this study', 'Teenagers', 'Pediatric patients older than 12 years with chronic perforations', 'Tertiary referral center']","['overlay-underlay and underly cartilage myringoplasty', 'Endoscopic inlay cartilage and perichondrium myringoplasty']","['CT examination', 'hearing outcome', 'graft success rate', 'graft success rate, hearing improvement, and complications']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0444456', 'cui_str': 'Overlay'}, {'cui': 'C0444455', 'cui_str': 'Underlay'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0225361', 'cui_str': 'Perichondrium'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",80.0,0.0407142,"The graft success rate was 100% in the intervention group and 95.1% in the control group at postoperative 3 months, the difference wasn't significant (P = 0.496).","[{'ForeName': 'Zhengcai', 'Initials': 'Z', 'LastName': 'Lou', 'Affiliation': 'Department of Otorhinolaryngology, Yiwu Central Hospital, Yiwu City, 322000, Zhejiang province, China. Electronic address: louzhengcai@163.com.'}, {'ForeName': 'Kangfeng', 'Initials': 'K', 'LastName': 'Jin', 'Affiliation': 'Department of Otorhinolaryngology, Yiwu Central Hospital, Yiwu City, 322000, Zhejiang province, China.'}, {'ForeName': 'Junzhi', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Otorhinolaryngology, Yiwu Central Hospital, Yiwu City, 322000, Zhejiang province, China.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2021.110915']
1542,34507046,Effects of dry needling on mechanical and contractile properties of the upper trapezius with latent myofascial trigger points: A randomized controlled trial.,"BACKGROUND


Latent trigger point (LTrP) can cause motor dysfunction and disturb normal patterns of motor recruitment.
OBJECTIVE


To analyze the effects of DN in the upper trapezius (UT) LTrP on pain and the mechanical and contractile properties of the muscle.
DESIGN


A randomized, double-blinded, parallel-group-trial.
METHODS


Fifty healthy volunteers with LTrPs in the UT were randomly divided into a DN-group (n = 26) and a Sham-DN-group (n = 24) and received one session of DN or placebo treatment. Mechanical and contractile properties of the muscle and pressure pain perception (PPP) were evaluated before treatment and in a 30min, 24 h and 72 h follow-up after treatment.
RESULTS


In the mechanical properties, the DN-group showed lower values than the Sham-DN-group for dynamic stiffness at 72 h (p = 0.04). The DN-group showed lower values for dynamic stiffness at 72 h from baseline (278.74 ± 38.40 to 261.54 ± 33.64 N/m; p = 0.01) and for tone at 72 h from 30min (16.62 ± 1.27 to 15.88 ± 1.31 Hz; p = 0.01). In the contractile properties, the DN-group showed higher values for maximal radial displacement (Dm) of the muscle belly at 72 h from baseline (5.38 ± 1.67 to 6.13 ± 1.70 mm; p = 0.04), higher values for contraction time at 30min (28.53 ± 8.80 s; p = 0.03) and lower ones at 72 h (24.74 ± 4.36 s; p = 0.04) from baseline (26.97 ± 6.63 s). The DN-group showed a decrease of PPP from baseline to 72 h after treatment (5.16 ± 1.33 to 4.02 ± 0.97 mm; p < 0.01).
CONCLUSION


The application of DN in healthy volunteers over LTrPs in the UT decreased dynamic stiffness, tone and contraction time and increased Dm at 72 h after treatment. Additionally, the PPP showed a decrease at 72 h after needling. CLINICALTRIALS.GOV: NCT04466813.",2021,"In the contractile properties, the DN-group showed higher values for maximal radial displacement (Dm) of the muscle belly at 72 h from baseline (5.38 ± 1.67 to 6.13 ± 1.70 mm; p = 0.04), higher values for contraction time at 30min (28.53 ± 8.80 s; p = 0.03) and lower ones at 72 h (24.74 ± 4.36 ","['healthy volunteers', 'Fifty healthy volunteers with LTrPs in the UT', 'upper trapezius with latent myofascial trigger points']","['Latent trigger point (LTrP', 'Sham-DN-group (n\xa0=\xa024) and received one session of DN or placebo treatment', 'dry needling']","['maximal radial displacement (Dm) of the muscle belly', 'contraction time', 'PPP', 'dynamic stiffness, tone and contraction time and increased Dm', 'Mechanical and contractile properties of the muscle and pressure pain perception (PPP', 'dynamic stiffness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}]","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0224086', 'cui_str': 'Belly of skeletal muscle'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",50.0,0.450111,"In the contractile properties, the DN-group showed higher values for maximal radial displacement (Dm) of the muscle belly at 72 h from baseline (5.38 ± 1.67 to 6.13 ± 1.70 mm; p = 0.04), higher values for contraction time at 30min (28.53 ± 8.80 s; p = 0.03) and lower ones at 72 h (24.74 ± 4.36 ","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sánchez-Infante', 'Affiliation': 'Performance and Sport Rehabilitation Laboratory, Faculty of Sport Sciences, University of Castilla-La Mancha, Toledo, Spain; Hospital Universitario de Toledo, Castilla La Mancha, Toledo, Spain. Electronic address: Jorge.fisio.uclm@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bravo-Sánchez', 'Affiliation': 'Performance and Sport Rehabilitation Laboratory, Faculty of Sport Sciences, University of Castilla-La Mancha, Toledo, Spain. Electronic address: Alfredo_Recas@gmail.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Jiménez', 'Affiliation': 'Performance and Sport Rehabilitation Laboratory, Faculty of Sport Sciences, University of Castilla-La Mancha, Toledo, Spain. Electronic address: JoseFernando.Jimenez@uclm.es.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Abián-Vicén', 'Affiliation': 'Performance and Sport Rehabilitation Laboratory, Faculty of Sport Sciences, University of Castilla-La Mancha, Toledo, Spain. Electronic address: javier.abian@uclm.es.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2021.102456']
1543,34529114,"Caffeine, genetic variation and anaerobic performance in male athletes: a randomized controlled trial.","PURPOSE


The effect of caffeine on anaerobic performance is unclear and may differ depending on an individual's genetics. The goal of this study was to determine whether caffeine influences anaerobic performance in a 30 s Wingate test, and if 14 single nucleotide polymorphisms (SNPs) in nine genes, associated with caffeine metabolism or response, modify caffeine's effects.
METHODS


Competitive male athletes (N = 100; 25 ± 4 years) completed the Wingate under three conditions: 0, 2, or 4 mg of caffeine per kg of body mass (mg kg -1 ), using a double-blinded, placebo-controlled design. Using saliva samples, participants were genotyped for the 14 SNPs. The outcomes were peak power (Watts [W]), average power (Watts [W]), and fatigue index (%).
RESULTS


There was no main effect of caffeine on Wingate outcomes. One significant caffeine-gene interaction was observed for CYP1A2 (rs762551, p = 0.004) on average power. However, post hoc analysis showed no difference in caffeine's effects within CYP1A2 genotypes for average power performance. No significant caffeine-gene interactions were observed for the remaining SNPs on peak power, average power and fatigue index.
CONCLUSION


Caffeine had no effect on anaerobic performance and variations in several genes did not modify any effects of caffeine.
TRIAL REGISTRATION


This study was registered with clinicaltrials.gov (NCT02109783).",2021,"However, post hoc analysis showed no difference in caffeine's effects within CYP1A2 genotypes for average power performance.","['male athletes', 'Competitive male athletes (N\u2009=\u2009100; 25\u2009±\u20094\xa0years']","['Caffeine', 'caffeine', 'placebo-controlled design']","['peak power, average power and fatigue index', 'anaerobic performance', 'peak power (Watts [W]), average power (Watts [W]), and fatigue index ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439261', 'cui_str': 'watt'}]",,0.244383,"However, post hoc analysis showed no difference in caffeine's effects within CYP1A2 genotypes for average power performance.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sicova', 'Affiliation': ""Temerty Faculty of Medicine, Department of Nutritional Sciences, University of Toronto, 1 King's College Circle, Room 5326A, Toronto, ON, M5S 1A8, Canada.""}, {'ForeName': 'Nanci S', 'Initials': 'NS', 'LastName': 'Guest', 'Affiliation': ""Temerty Faculty of Medicine, Department of Nutritional Sciences, University of Toronto, 1 King's College Circle, Room 5326A, Toronto, ON, M5S 1A8, Canada.""}, {'ForeName': 'Pascal N', 'Initials': 'PN', 'LastName': 'Tyrrell', 'Affiliation': 'Faculty of Arts and Science, Department of Statistical Sciences, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Sohemy', 'Affiliation': ""Temerty Faculty of Medicine, Department of Nutritional Sciences, University of Toronto, 1 King's College Circle, Room 5326A, Toronto, ON, M5S 1A8, Canada. a.el.sohemy@utoronto.ca.""}]",European journal of applied physiology,['10.1007/s00421-021-04799-x']
1544,34481910,Comparison of efficacy between dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter 2 inhibitor on metabolic risk factors in Japanese patients with type 2 diabetes mellitus: Results from the CANTABILE study.,"AIMS


The aim of this study was to compare the effectiveness of teneligliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and canagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, at reducing a composite outcome of three metabolic risk factors (obesity, hypertension, and dyslipidemia) in Japanese patients with type 2 diabetes mellitus (T2DM) and metabolic risks.
METHODS


In this prospective, multicenter, open-label, randomized, parallel-group comparison study, 162 patients with T2DM and one or more metabolic risk factors were randomized into a teneligliptin or canagliflozin group and treated for 24 weeks. The primary endpoint was the composite percentage of subjects who experienced an improvement in at least one metabolic risk after 24 weeks of treatment.
RESULTS


The primary endpoint was achieved significantly by more patients in the canagliflozin group than in the teneligliptin group (62.2% vs. 31.3%, p = 0.0004). A ≥ 3% body weight loss was also achieved by significantly more participants in the canagliflozin group than in the teneligliptin group (55.9% vs. 10.5%, p < 0.0001).
CONCLUSIONS


This study showed canagliflozin to be more effective at reducing metabolic risks than teneligliptin. In Japanese patients with T2DM and metabolic risk factors, SGLT2 inhibitors may be superior to DPP-4 inhibitors at controlling multiple metabolic risk.",2021,"A ≥3% body weight loss was also achieved by significantly more participants in the canagliflozin group than in the teneligliptin group (55.9% vs. 10.5%, p < 0.0001).
","['Japanese patients with type 2 diabetes mellitus (T2DM) and metabolic risks', '162 patients with T2DM and one or more metabolic risk factors', 'Japanese patients with T2DM and metabolic risk factors', 'Japanese Patients with Type 2 Diabetes Mellitus']","['Dipeptidyl Peptidase-4 Inhibitor and Sodium-Glucose', 'Cotransporter 2 Inhibitor', 'canagliflozin', 'teneligliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and canagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor', 'teneligliptin', 'teneligliptin or canagliflozin']","['metabolic risks', 'metabolic risk factors (obesity, hypertension, and dyslipidemia', 'Metabolic Risk Factors', 'composite percentage of subjects who experienced an improvement in at least one metabolic risk', 'body weight loss']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",162.0,0.0125341,"A ≥3% body weight loss was also achieved by significantly more participants in the canagliflozin group than in the teneligliptin group (55.9% vs. 10.5%, p < 0.0001).
","[{'ForeName': 'Cheol', 'Initials': 'C', 'LastName': 'Son', 'Affiliation': 'Division of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Division of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kasahara', 'Affiliation': 'Nara Medical University Hospital, Kashihara, Japan. Electronic address: kasa@naramed-u.ac.jp.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Department of Preventive Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Taneda', 'Affiliation': 'Manda Memorial Hospital, Sapporo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nishimura', 'Affiliation': 'Takanohara Central Hospital, Nara, Japan.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Kasama', 'Affiliation': 'Nara Medical University Hospital, Kashihara, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kiminori', 'Initials': 'K', 'LastName': 'Hosoda', 'Affiliation': 'Division of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Suita, Japan.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2021.109037']
1545,34496085,Do postoperative antibiotics influence one-year peri-implant crestal bone remodelling and morbidity? A double-blinded randomized clinical trial.,"OBJECTIVES


The primary objective of this study was to assess whether giving postoperative antibiotics to healthy patients after straightforward platform-switched implant placement would influence peri-implant crestal bone levels and postoperative morbidity after 1 year.
METHODS


Thirty-eight healthy individuals were recruited in this pilot, randomized, double-blinded, placebo-controlled clinical trial. The intervention group (n = 18) received two grams of amoxicillin one hour before implant placement followed by a 7 days postoperative regimen (500 mg tid). The control group (n = 20) took the same preoperative dose of amoxicillin and an identical placebo postoperatively. Mesial and distal peri-implant crestal bone levels were measured at baseline, four months and one year later with standardized periapical radiographs. Postoperative pain severity was assessed through self-administered questionnaires for 7 days. Surgery-associated morbidities were evaluated after one, three, 16 weeks and 1 year. Descriptive and bivariate analyses were used.
RESULTS


Thirty-seven participants completed the trial. At the one-year follow-up, the mean combined peri-implant crestal bone changes for the intervention (n = 18) and control (n = 19) groups were - 0.44 ± 0.41 mm and - 0.27 ± 0.56 mm, respectively. The difference between the groups (intervention-control) for mean combined crestal bone level changes was not statistically significant. There were no significant differences in surgery-associated morbidities between the intervention and control groups. The one-year implant survival rate was 100% in both groups.
CONCLUSIONS


Study results suggest that a routine postoperative antibiotic regimen for healthy patients undergoing straightforward platform-switched implant placement might not be necessary to prevent postoperative peri-implant bone loss and complications.",2021,The difference between the groups (intervention-control) for mean combined crestal bone level changes was not statistically significant.,"['healthy patients after', 'Thirty-eight healthy individuals', 'Thirty-seven participants completed the trial', 'healthy patients undergoing']","['amoxicillin and an identical placebo', 'placebo', 'straightforward platform-switched implant placement', 'amoxicillin']","['Postoperative pain severity', 'peri-implant crestal bone levels and postoperative morbidity', 'Mesial and distal peri-implant crestal bone levels', 'mean combined crestal bone level changes', 'surgery-associated morbidities', 'Surgery-associated morbidities', 'implant survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1272701', 'cui_str': 'Straightforward'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",38.0,0.220998,The difference between the groups (intervention-control) for mean combined crestal bone level changes was not statistically significant.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Durand', 'Affiliation': 'Department of Oral Health, Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Kersheh', 'Affiliation': 'Department of Oral Health, Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Marcotte', 'Affiliation': 'Department of Oral Health, Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boudrias', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Schmittbuhl', 'Affiliation': 'Department of Dental Medicine, Université de Montréal Hospital Center (CHUM), Montreal, QC, Canada.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Cresson', 'Affiliation': 'Université de Montréal Hospital Research Center (CR-CHUM), Montreal, QC, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Rei', 'Affiliation': 'Department of Stomatology, Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Pierre H', 'Initials': 'PH', 'LastName': 'Rompré', 'Affiliation': 'Department of Oral Health, Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Voyer', 'Affiliation': 'Department of Oral Health, Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}]",Clinical oral implants research,['10.1111/clr.13832']
1546,34499396,Assessment of ECG during hybrid comprehensive telerehabilitation in heart failure patients-Subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) randomized clinical trial.,"BACKGROUND


Exercise training in heart failure (HF) patients should be monitored to ensure patients' safety. Electrocardiographic (ECG) telemonitoring was used to assess the safety of hybrid comprehensive telerehabilitation (HCTR).
OBJECTIVE


Analysis of ECG recorded during HCTR in HF patients.
METHODS


The TELEREH-HF multicenter, randomized, controlled trial enrolled 850 HF patients with New York Heart Association class I-III and left ventricular ejection fraction of ≤40%. This subanalysis focuses on 386 patients (aged 62 ± 11 years, LVEF 31 ± 7%) randomized to HCTR. HCTR was telemonitored with a device allowing to record 16-s fragments of ECG and to transmit the data via mobile phone network to the monitoring center. ResultsIn 386 patients, 16,622 HCTR sessions were recorded and 66,488 ECGs fragments were evaluated. Sinus rhythm was present in 320 (83%) and permanent atrial fibrillation (AF) in 66 (17%) patients, respectively. The most common arrhythmias were ventricular and atrial premature beats, recorded in 76.4% and 27.7% of the patients, respectively. Non-sustained ventricular tachycardia (21 episodes in 8 patients) and paroxysmal AF episodes (6 in 4 patients) were rare. None of the analyzed demographic and clinical characteristics was predictive for onset of the new arrhythmias on exercise.
CONCLUSION


Telerehabilitation in HF patients was safe without the evidence for symptomatic arrhythmias requiring discontinuation of telerehabilitation. Only one mildly symptomatic paroxysmal AF episode led to the short-term suspension of the training program. The most common arrhythmias were atrial and ventricular premature beats. These arrhythmias did not result in any changes in rehabilitation and therapy regimens.",2021,Telerehabilitation in HF patients was safe without the evidence for symptomatic arrhythmias requiring discontinuation of telerehabilitation.,"['heart failure patients-Subanalysis of the Telerehabilitation in Heart Failure Patients', 'heart failure (HF) patients', 'HF patients', '386 patients (aged 62\xa0±\xa011\xa0years, LVEF 31\xa0±\xa07%) randomized to', '850 HF patients with New York Heart Association class I-III and left ventricular ejection fraction of ≤40', 'ResultsIn 386 patients, 16,622 HCTR sessions were recorded and 66,488 ECGs fragments were evaluated']","['HCTR', 'hybrid comprehensive telerehabilitation (HCTR', 'Exercise training', 'ECG during hybrid comprehensive telerehabilitation']","['mildly symptomatic paroxysmal AF episode', 'Sinus rhythm', 'permanent atrial fibrillation (AF', 'ventricular and atrial premature beats', 'paroxysmal AF episodes']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C2586056', 'cui_str': 'Permanent atrial fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}]",850.0,0.0852958,Telerehabilitation in HF patients was safe without the evidence for symptomatic arrhythmias requiring discontinuation of telerehabilitation.,"[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Orzechowski', 'Affiliation': 'Telecardiology Center, National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Piotrowicz', 'Affiliation': 'Department of Coronary Disease and Rehabilitation, National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zaręba', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Główczyńska', 'Affiliation': '1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Szalewska', 'Affiliation': 'Chair and Clinic of Rehabilitation Medicine, Faculty of Health Sciences, Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Pluta', 'Affiliation': 'Silesian Center for Heart Diseases, Zabrze, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Irzmański', 'Affiliation': 'Department of Internal Medicine and Cardiac Rehabilitation, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Kalarus', 'Affiliation': 'Department of Cardiology, DMS in Zabrze, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': 'Department of Hypertension, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Opolski', 'Affiliation': '1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Pencina', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Kowalik', 'Affiliation': 'National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Piotrowicz', 'Affiliation': 'Telecardiology Center, National Institute of Cardiology, Warsaw, Poland.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12887']
1547,34498944,Aerobic exercise with blood flow restriction causes local and systemic hypoalgesia and increases circulating opioid and endocannabinoid levels.,"This study examined the effect of aerobic exercise with and without blood flow restriction (BFR) on exercise-induced hypoalgesia and endogenous opioid and endocannabinoid systems. In a randomized crossover design, pain-free individuals performed 20 min of cycling in four experimental trials:  1 ) low-intensity aerobic exercise (LI-AE) at 40% V̇o 2max ;  2 ) LI-AE with low-pressure BFR (BFR40);  3 ) LI-AE with high-pressure BFR (BFR80); and  4 ) high-intensity aerobic exercise (HI-AE) at 70% V̇o 2max . Pressure pain thresholds (PPTs) were assessed before and 5 min postexercise. Circulating concentrations of beta-endorphin and 2-arachidonoylglycerol were assessed before and 10 min postexercise. In the exercising legs, postexercise PPTs were increased following BFR40 and BFR80 compared with LI-AE (23-32% vs. 1-2% increase, respectively). The increase in PPTs was comparable to HI-AE (17-20% increase) with BFR40 and greater with BFR80 (30-32% increase). Both BFR80 and HI-AE increased PPTs in remote areas of the body (increase of 26-28% vs. 19-21%, respectively). Postexercise circulating beta-endorphin concentration was increased following BFR40 (11%) and HI-AE (14%), with the greatest change observed following BFR80 (29%). Postexercise circulating 2-arachidonoylglycerol concentration was increased following BFR40 (22%) and BFR80 (20%), with the greatest change observed following HI-AE (57%). Addition of BFR to LI-AE can trigger both local and systemic hypoalgesia that is not observed follow LI-AE alone and activate endogenous opioid and endocannabinoid systems of pain inhibition. Compared with HI-AE, local and systemic hypoalgesia following LI-AE with high-pressure BFR is greater and comparable, respectively. LI-AE with BFR may help pain management in load-compromised individuals. NEW & NOTEWORTHY  We have shown that performing blood flow restriction (BFR) during low-intensity aerobic exercise can trigger local and systemic hypoalgesia, which is not typically observed with this intensity of exercise. High-pressure BFR triggers greater and comparable hypoalgesia than high-intensity aerobic exercise in the exercising limbs and remote areas of the body, respectively. Performing BFR during low-intensity aerobic exercise activates the opioid and endocannabinoid systems, providing novel insight into potential mechanisms of hypoalgesia with BFR exercise.",2021,"Post-exercise circulating 2-arachidonoylglycerol concentration was increased following BFR40 (22%) and BFR80 (20%), with the greatest change observed following HI-AE (57%).
",[],"['LI-AE with BFR', 'aerobic exercise with and without blood flow restriction', 'Aerobic exercise with blood flow restriction', 'Low intensity aerobic exercise (LI-AE) at 40% V̇O 2max ; 2) LI-AE with low pressure BFR (BFR40); 3) LI-AE with high pressure BFR (BFR80); and 4) High intensity aerobic exercise (HI-AE) 70% V̇O 2max ', 'BFR80 and HI-AE']","['Post-exercise circulating beta-endorphin concentration', 'Circulating concentrations of beta-endorphin and 2-arachidonoylglycerol', 'BFR40 and BFR80', 'Pressure pain thresholds (PPT', 'Post-exercise circulating 2-arachidonoylglycerol concentration', 'systemic hypoalgesia']",[],"[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005210', 'cui_str': 'Beta endorphin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0299477', 'cui_str': 'glyceryl 2-arachidonate'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia'}]",,0.0657746,"Post-exercise circulating 2-arachidonoylglycerol concentration was increased following BFR40 (22%) and BFR80 (20%), with the greatest change observed following HI-AE (57%).
","[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Hughes', 'Affiliation': ""Centre for Applied Performance Sciences, Faculty of Sport, Allied Health, and Performance Sciences, St. Mary's University, London, United Kingdom.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Grant', 'Affiliation': ""Centre for Applied Performance Sciences, Faculty of Sport, Allied Health, and Performance Sciences, St. Mary's University, London, United Kingdom.""}, {'ForeName': 'Stephen David', 'Initials': 'SD', 'LastName': 'Patterson', 'Affiliation': ""Centre for Applied Performance Sciences, Faculty of Sport, Allied Health, and Performance Sciences, St. Mary's University, London, United Kingdom.""}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00543.2021']
1548,34498135,Maximal strength training-induced increase in efferent neural drive is not reflected in relative protein expression of SERCA.,"INTRODUCTION


Maximal strength training (MST), performed with heavy loads (~ 90% of one repetition maximum; 1RM) and few repetitions, yields large improvements in efferent neural drive, skeletal muscle force production, and skeletal muscle efficiency. However, it is elusive whether neural adaptations following such high intensity strength training may be accompanied by alterations in energy-demanding muscular factors.
METHODS


Sixteen healthy young males (24 ± 4 years) were randomized to MST 3 times per week for 8 weeks (n = 8), or a control group (CG; n = 8). Measurements included 1RM and rate of force development (RFD), and evoked potentials recordings (V-wave and H-reflex normalized to M-wave (M) in the soleus muscle) applied to assess efferent neural drive to maximally contracting skeletal muscle. Biopsies were obtained from vastus lateralis and analyzed by western blots and real-time PCR to investigate the relative protein expression and mRNA expression of Sarcoplasmic Reticulum Ca 2+  ATPase (SERCA) 1 and SERCA2.
RESULTS


Significant improvements in 1RM (17 ± 9%; p < 0.001) and early (0-100 ms), late (0-200 ms) and maximal RFD (31-53%; p < 0.01) were observed after MST, accompanied by increased maximal V max /M sup -ratio (9 ± 14%; p = 0.046), with no change in H-reflex to M-wave ratio. No changes were observed in the CG. No pre- to post-training differences were found in mRNA or protein expressions of SERCA1 and SERCA2 in either group.
CONCLUSION


MST increased efferent neural drive to maximally contracting skeletal muscle, causing improved force production. No change was observed in SERCA expression, indicating that responses to high intensity strength training may predominantly be governed by neural adaptations.",2021,"No pre- to post-training differences were found in mRNA or protein expressions of SERCA1 and SERCA2 in either group.
","['Sixteen healthy young males (24\u2009±\u20094\xa0years', 'sup']","['Maximal strength training (MST', 'MST']","['maximal V max /M', '1RM', 'mRNA or protein expressions of SERCA1 and SERCA2', 'maximal RFD', 'SERCA expression', '1RM and rate of force development (RFD), and evoked potentials recordings (V-wave and H-reflex normalized to M-wave (M', 'ratio']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1451765', 'cui_str': 'SNAP25 protein, human'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0916183', 'cui_str': 'Sarcoplasmic-Endoplasmic Reticulum Calcium ATPase 2'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C4301968', 'cui_str': 'v wave'}, {'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",16.0,0.0140174,"No pre- to post-training differences were found in mRNA or protein expressions of SERCA1 and SERCA2 in either group.
","[{'ForeName': 'Tiril', 'Initials': 'T', 'LastName': 'Tøien', 'Affiliation': 'Department of Health and Social Sciences, Molde University College, Britvegen 2, 6410, Molde, Norway. tiril.toien@himolde.no.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Haglo', 'Affiliation': 'Department of Health and Social Sciences, Molde University College, Britvegen 2, 6410, Molde, Norway.'}, {'ForeName': 'Stian Kwak', 'Initials': 'SK', 'LastName': 'Nyberg', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Shalini Vasudev', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Astrid Kamilla', 'Initials': 'AK', 'LastName': 'Stunes', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Mats Peder', 'Initials': 'MP', 'LastName': 'Mosti', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Health and Social Sciences, Molde University College, Britvegen 2, 6410, Molde, Norway.'}]",European journal of applied physiology,['10.1007/s00421-021-04807-0']
1549,34504252,Effect of changes in inspired oxygen fraction on oxygen delivery during cardiac surgery: a substudy of the CARROT trial.,"When hemoglobin (Hb) is fully saturated with oxygen, the additional gain in oxygen delivery (DO 2 ) achieved by increasing the fraction of inspired oxygen (FiO 2 ) is often considered clinically insignificant. In this study, we evaluated the change in DO 2 , interrogated by mixed venous oxygen saturation (SvO 2 ), in response to a change in FiO 2  of 0.5 during cardiac surgery. When patients were hemodynamically stable, FiO 2  was alternated between 0.5 and 1.0 in on-pump cardiac surgery patients (pilot study), and between 0.3 and 0.8 in off-pump coronary artery bypass grafting patients (substudy of the CARROT trial). After the patient had stabilized, a blood gas analysis was performed to measure SvO 2 . The observed change in SvO 2  (ΔSvO 2 ) was compared to the expected ΔSvO 2  calculated using Fick's equation. A total 106 changes in FiO 2  (two changes per patient; total 53 patients; on-pump, n = 36; off-pump, n = 17) were finally analyzed. While Hb saturation remained near 100% (on-pump, 100%; off-pump, mean [SD] = 98.1% [1.5] when FiO 2  was 0.3 and 99.9% [0.2] when FiO 2  was 0.8), SvO 2  changed significantly as FiO 2  was changed (the first and second changes in on-pump, 7.7%p [3.8] and 7.6%p [3.5], respectively; off-pump, 7.9%p [4.9] and 6.2%p [3.9]; all P < 0.001). As a total, regardless of the surgery type, the observed ΔSvO 2  after the FiO 2  change of 0.5 was ≥ 5%p in 82 (77.4%) changes and ≥ 10%p in 31 (29.2%) changes (mean [SD], 7.5%p [3.9]). Hb concentration was not correlated with the observed ΔSvO 2  (the first changes, r =  - 0.06, P = 0.677; the second changes, r =  - 0.21, P = 0.138). The mean (SD) residual ΔSvO 2  (observed - expected ΔSvO 2 ) was 0%p (4). Residual ΔSvO 2  was more than 5%p in 14 (13.2%) changes and exceeded 10%p in 2 (1.9%) changes. Residual ΔSvO 2  was greater in patients with chronic kidney disease than in those without (median [IQR], 5%p [0 to 7] vs. 0%p [- 3 to 2]; P = 0.049). DO 2 , interrogated by SvO 2 , may increase to a clinically significant degree as FiO 2  is increased during cardiac surgery, and the increase of SvO 2  is not related to Hb concentration. SvO 2  increases more than expected in patients with chronic kidney disease. Increasing FiO 2  can be used to increase DO 2  during cardiac surgery.",2021,"DO 2 , interrogated by SvO 2 , may increase to a clinically significant degree as FiO 2  is increased during cardiac surgery, and the increase of SvO 2  is not related to Hb concentration.","['patients were hemodynamically stable, FiO 2  was alternated between 0.5 and 1.0 in on-pump cardiac surgery patients (pilot study), and between 0.3 and 0.8 in off-pump coronary artery bypass grafting patients (substudy of the CARROT trial', 'cardiac surgery', 'patients with chronic kidney disease']",['inspired oxygen fraction'],"['changes and\u2009≥', 'Residual ΔSvO 2', 'While Hb saturation', 'mean (SD) residual ΔSvO 2', 'Hb concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C1141640', 'cui_str': 'Carrot'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}]",106.0,0.0900008,"DO 2 , interrogated by SvO 2 , may increase to a clinically significant degree as FiO 2  is increased during cardiac surgery, and the increase of SvO 2  is not related to Hb concentration.","[{'ForeName': 'Karam', 'Initials': 'K', 'LastName': 'Nam', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, 03080, Korea.'}, {'ForeName': 'Hye-Bin', 'Initials': 'HB', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, 03722, Korea.'}, {'ForeName': 'Young-Lan', 'Initials': 'YL', 'LastName': 'Kwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, 03722, Korea.'}, {'ForeName': 'Young Hyun', 'Initials': 'YH', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, 03080, Korea.'}, {'ForeName': 'Jae-Woo', 'Initials': 'JW', 'LastName': 'Ju', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, 03080, Korea.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, 03080, Korea.'}, {'ForeName': 'Seohee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, 03080, Korea.'}, {'ForeName': 'Youn Joung', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, 03080, Korea.'}, {'ForeName': 'Jae-Kwang', 'Initials': 'JK', 'LastName': 'Shim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, 03722, Korea. aneshim@yuhs.ac.'}, {'ForeName': 'Yunseok', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, 03080, Korea. jeonyunseok@gmail.com.'}]",Scientific reports,['10.1038/s41598-021-97555-2']
1550,34500356,"Comparison of three different bulk-filling techniques for restoring class II cavities: μCT, SEM-EDS combined analyses for margins and internal fit assessments.","OBJECTIVE


Evaluation of the behavior of three different bulk-filling techniques in terms of internal adaptation and external marginal sealing for restoring class II cavities.
METHODS


Fifteen extracted sound molar teeth were used. Two standardized class II mesio/disto-occlusal (MO/DO) slot cavities, 4 mm long, 4 mm wide and 3 mm deep were prepared in each tooth, obtaining n=30 cavity preparations. The cavities were randomly assigned into three groups (n=10 per group) according to three bulk filling techniques: Bulk Traditional (BT), Bulk&Go (BG) and Bulk&Flow (BF). The teeth were analyzed by scanning electron microscopy (SEM) to investigate the external marginal seal. Thereafter, the chemical composition of tooth-restoration interface was analyzed by energy-dispersive X-ray spectroscopy (EDS). Complementary information to the SEM and EDS were obtained by micro-computed tomography (μCT) to assess the internal fit.
RESULTS


SEM analysis showed a proper external marginal seal for all groups tested as confirmed by the EDS investigation, highlighting the presence of adhesive layer at the tooth-restoration interface. The internal marginal adaptation by means of μCT analysis revealed gaps formation at the tooth-restoration interface only for BT group, while an intimate contact free of gaps were found in the other two groups. Moreover, in BT and BF groups voids were present within the restoration.
SIGNIFICANCE


BG and BF techniques can be considered as reliable alternatives to BT technique, as they simplify the class II restoration without transforming it into class I, thus ensuring a successful result.",2021,"The internal marginal adaptation by means of μCT analysis revealed gaps formation at the tooth-restoration interface only for BT group, while an intimate contact free of gaps were found in the other two groups.","['Fifteen extracted sound molar teeth were used', 'n=30 cavity preparations']","['three bulk filling techniques: Bulk Traditional (BT), Bulk&Go (BG) and Bulk&Flow (BF', 'Two standardized class II mesio/disto-occlusal (MO/DO']",[],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}]",[],15.0,0.0247761,"The internal marginal adaptation by means of μCT analysis revealed gaps formation at the tooth-restoration interface only for BT group, while an intimate contact free of gaps were found in the other two groups.","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Putignano', 'Affiliation': 'Department of Clinical Sciences and Stomatology (DISCO), Polytechnic University of Marche, Via Toronto 10/a, 60126, Ancona, Italy. Electronic address: a.putignano@univpm.it.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Tosco', 'Affiliation': 'Department of Clinical Sciences and Stomatology (DISCO), Polytechnic University of Marche, Via Toronto 10/a, 60126, Ancona, Italy. Electronic address: v.tosco@pm.univpm.it.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Monterubbianesi', 'Affiliation': 'Department of Clinical Sciences and Stomatology (DISCO), Polytechnic University of Marche, Via Toronto 10/a, 60126, Ancona, Italy. Electronic address: r.monterubbianesi@pm.univpm.it.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Vitiello', 'Affiliation': 'Department of Clinical Sciences and Stomatology (DISCO), Polytechnic University of Marche, Via Toronto 10/a, 60126, Ancona, Italy. Electronic address: flavit94@libero.it.'}, {'ForeName': 'Maria Laura', 'Initials': 'ML', 'LastName': 'Gatto', 'Affiliation': 'Department of Materials, Environmental Sciences and Urban Planning (SIMAU), Polytechnic University of Marche, Via Brecce Bianche 12, 60131, Ancona, Italy. Electronic address: m.l.gatto@pm.univpm.it.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Furlani', 'Affiliation': 'Department of Clinical Sciences and Stomatology (DISCO), Polytechnic University of Marche, Via Toronto 10/a, 60126, Ancona, Italy. Electronic address: m.furlani@pm.univpm.it.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Giuliani', 'Affiliation': 'Department of Clinical Sciences and Stomatology (DISCO), Polytechnic University of Marche, Via Toronto 10/a, 60126, Ancona, Italy. Electronic address: a.giuliani@univpm.it.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Orsini', 'Affiliation': 'Department of Clinical Sciences and Stomatology (DISCO), Polytechnic University of Marche, Via Toronto 10/a, 60126, Ancona, Italy. Electronic address: g.orsini@univpm.it.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2021.104812']
1551,34500245,Integrating social media inspired features into a personalized normative feedback intervention combats social media-based alcohol influence.,"BACKROUND


Research suggests that the social media platforms popular on college campuses may reflect, reinforce, and even exacerbate heavy drinking practices among students. The present study was designed to directly examine: (1) whether exposure to alcohol-related content on social media diminishes the efficacy of a traditional web-based personalized normative feedback (PNF) alcohol intervention among first-year drinkers; and (2) if social media inspired features and digital game mechanics can be integrated into a PNF intervention to combat social media-based alcohol influence and increase efficacy.
METHOD


Alcohol experienced first-year college students (N = 223) completed a pre-survey that assessed exposure to alcohol-related content and social media and were randomized to 1 of 3 web-based alcohol PNF conditions (traditional, gamified only, or social media inspired gamified). One month later, participants' alcohol consumption was reassessed.
RESULTS


Among participants who received traditional PNF, social media-based alcohol exposure interacted with pre-intervention drinking such that traditional PNF was less effective in reducing drinking among heavier drinkers reporting greater exposure to alcohol-related social media content. Further, when regression models compared the efficacy of all three conditions, the social media inspired gamified PNF condition was significantly more effective in reducing drinking than was traditional PNF among moderate and heavy drinkers reporting greater exposure to alcohol on social media.
CONCLUSION


Although additional research is needed, these findings suggest that representing the population of students on whom normative statistics are based with social media-like user avatars and profiles may enhance the degree to which alcohol PNF is relatable and believable among high-risk students.",2021,"Further, when regression models compared the efficacy of all three conditions, the social media inspired gamified PNF condition was significantly more effective in reducing drinking than was traditional PNF among moderate and heavy drinkers reporting greater exposure to alcohol on social media.
",['Alcohol experienced first-year college students (N\u2009=\u2009223) completed a'],"['traditional web-based personalized normative feedback (PNF) alcohol intervention', 'traditional PNF, social media-based alcohol exposure interacted with pre-intervention drinking such that traditional PNF', 'pre-survey that assessed exposure to alcohol-related content and social media and were randomized to 1 of 3 web-based alcohol PNF conditions (traditional, gamified only, or social media inspired gamified']",[],"[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4038778', 'cui_str': 'Exposure to alcohol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]",[],,0.00582168,"Further, when regression models compared the efficacy of all three conditions, the social media inspired gamified PNF condition was significantly more effective in reducing drinking than was traditional PNF among moderate and heavy drinkers reporting greater exposure to alcohol on social media.
","[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Boyle', 'Affiliation': 'Loyola Marymount University, Department of Psychology, Los Angeles, CA, 90045, United States. Electronic address: sarah.boyle@lmu.edu.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'LaBrie', 'Affiliation': 'Loyola Marymount University, Department of Psychology, Los Angeles, CA, 90045, United States.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Baez', 'Affiliation': 'Loyola Marymount University, Department of Psychology, Los Angeles, CA, 90045, United States.'}, {'ForeName': 'J Eason', 'Initials': 'JE', 'LastName': 'Taylor', 'Affiliation': 'Loyola Marymount University, Department of Psychology, Los Angeles, CA, 90045, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109007']
1552,34500234,"The ""alcoholic other"": Harmful drinkers resist problem recognition to manage identity threat.","OBJECTIVE


Harmful drinkers represent an important Alcohol Use Disorder (AUD) group in public health terms, accounting for significant health and social costs. However, harmful drinkers are characterized by low problem recognition; they tend to construct their drinking identity as positive and problem-free, actively setting themselves apart from the stigmatised 'alcoholic other'. As such, harmful drinkers rarely engage in treatment and represent an important opportunity for lower threshold interventions and self-change. The present study sought to explore AUD problem framing and stigma effects on problem recognition.
METHODS


Harmful drinkers without perceived addiction experience recruited online (n = 244, 54% male, 46% female, 96% British) were randomised to one of six conditions comprising beliefs about alcohol problems (control, continuum, binary disease model) and stigma (stigma, non-stigma), and completed measures relating to problem recognition.
RESULTS


As predicted, results found that harmful drinkers exposed to binary disease model beliefs and stigmatising language had significantly lower problem recognition than those in other conditions. However, no support was found for the prediction that continuum beliefs would be associated with higher problem recognition. Results suggest that the interaction of binary disease model beliefs and stigma prompted alcoholic label avoidance.
CONCLUSION


These findings suggest that problem framing has important consequences for harmful drinkers. Implications for behaviour change amongst harmful drinkers through mechanisms of problem framing and identity are discussed.",2022,"As predicted, results found that harmful drinkers exposed to binary disease model beliefs and stigmatising language had significantly lower problem recognition than those in other conditions.","['Harmful drinkers without perceived addiction experience recruited online (n\xa0=\xa0244, 54% male, 46% female, 96% British']","['six conditions comprising beliefs about alcohol problems (control, continuum, binary disease model) and stigma (stigma, non-stigma), and completed measures relating to problem recognition']",['problem recognition'],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",,0.025237,"As predicted, results found that harmful drinkers exposed to binary disease model beliefs and stigmatising language had significantly lower problem recognition than those in other conditions.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Centre for Addictive Behaviours Research, School of Applied Sciences, London South Bank University, United Kingdom. Electronic address: morrij24@lsbu.ac.uk.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Moss', 'Affiliation': 'Centre for Addictive Behaviours Research, School of Applied Sciences, London South Bank University, United Kingdom.'}, {'ForeName': 'I P', 'Initials': 'IP', 'LastName': 'Albery', 'Affiliation': 'Centre for Addictive Behaviours Research, School of Applied Sciences, London South Bank University, United Kingdom.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Heather', 'Affiliation': 'Faculty of Health & Life Sciences, Northumbria University, United Kingdom.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.107093']
1553,34510154,The Equivalency of the Binocular Indirect Ophthalmoscope Simulator to Peer Practice: A Pilot Study.,"SIGNIFICANCE


Optometric educators are constantly looking for learning and teaching approaches to improve clinical skills training. In addition, the COVID-19 pandemic has made educators scrutinize the time allocated to face-to-face teaching and practice. Simulation learning is an option, but its use must first be evaluated against traditional learning methods.
PURPOSE


The purpose of this study was to compare the training of binocular indirect ophthalmoscopy skills achieved by students and optometrists through deliberate practice on the Eyesi Indirect Ophthalmoscope simulator with deliberate practice using a peer.
METHODS


Students and optometrists were randomly allocated to practice on either the simulator or a peer. Binocular indirect ophthalmoscopy performance was assessed using a peer and the simulator as the patients at different time points. Knowledge and confidence were examined before and following all practice sessions using a quiz and survey.
RESULTS


Significant improvements in binocular indirect ophthalmoscopy performance using either a peer or the simulator as the patient for assessment were seen after 8 hours of student practice (P < .001) and after a half-hour practice time for optometrists (P < .001). There was no significant difference in performance overall between those practicing on a simulator and those practicing on a peer (P > .05). Confidence in ability to perform the technique was lower for students who had practiced on the simulator.
CONCLUSIONS


The simulator has similar efficacy to peer practice for teaching binocular indirect ophthalmoscopy to students and maintenance of this clinical skill for optometrists. Simulation does not replace the need for peer practice but may be a useful adjunct reducing the face-to-face hours required. These findings present a need for further research regarding diverse applications of the Eyesi Indirect Ophthalmoscope simulator in the curriculum for training optometry students and as a continuing professional development offering for optometrists, given the short exposure duration required to observe a significant improvement in skill.",2021,There was no significant difference in performance overall between those practicing on a simulator and those practicing on a peer (P > .05).,"['students and optometrists through deliberate practice on the Eyesi Indirect Ophthalmoscope simulator with deliberate practice using a peer', 'students who had practiced on the simulator', 'Students and optometrists']","['Binocular Indirect Ophthalmoscope Simulator', 'binocular indirect ophthalmoscopy skills']","['Binocular indirect ophthalmoscopy performance', 'performance overall', 'binocular indirect ophthalmoscopy performance']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0029146', 'cui_str': 'Optometrist'}, {'cui': 'C0182048', 'cui_str': 'Indirect ophthalmoscope'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C1444585', 'cui_str': 'Binocular indirect ophthalmoscope'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C1444584', 'cui_str': 'Binocular indirect ophthalmoscopy'}]","[{'cui': 'C1444584', 'cui_str': 'Binocular indirect ophthalmoscopy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0427719,There was no significant difference in performance overall between those practicing on a simulator and those practicing on a peer (P > .05).,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Douglass', 'Affiliation': ''}, {'ForeName': 'Kwang Meng', 'Initials': 'KM', 'LastName': 'Cham', 'Affiliation': 'Department of Optometry and Vision Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jaworski', 'Affiliation': ''}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Maillet', 'Affiliation': 'Department of Optometry, Deakin University, Waurn Ponds, Victoria, Australia.'}, {'ForeName': 'Anthea', 'Initials': 'A', 'LastName': 'Cochrane', 'Affiliation': 'Department of Optometry and Vision Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Armitage', 'Affiliation': ''}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001799']
1554,34510143,Correction of Ocular Aberrations with Prismatic Rigid Gas-permeable Contact Lenses in Keratoconic Eyes.,"SIGNIFICANCE


A base-down prism was incorporated on the anterior surface of rigid gas-permeable (RGP) contact lenses to explore potential effects on the residual ocular aberrations after contact lens fitting in keratoconic eyes.
PURPOSE


This study aimed to evaluate the correction of ocular aberrations with corneal prismatic RGP contact lenses in keratoconic eyes and their impact on visual function.
METHODS


A cross-sectional and randomized study was performed. Seventeen eyes of 17 keratoconus patients (34.6 ± 11.1 years) were evaluated. Two designs (standard and prismatic) of a corneal RGP contact lens (KAKC; Conoptica, Barcelona, Spain) were fitted to the same eye of each patient in a random order: a standard RGP contact lens as control and a prismatic RGP contact lens with a base-down prism of 1.6 prism diopters. Ocular aberrations were measured for a pupil diameter of 3 mm with and without both contact lenses, whereas high-contrast distance visual acuity, low-contrast distance visual acuity, and contrast sensitivity were measured under photopic and mesopic conditions.
RESULTS


Both contact lenses improved oblique primary astigmatism, defocus, vertical coma, coma-like, and root-mean-square higher-order aberrations compared with the unaided eyes (P < .05). Furthermore, the prismatic RGP contact lenses offered lower values of vertical coma and root-mean-square higher-order aberrations than the standard RGP contact lenses (P < .05). Both designs (standard and prismatic) produced a positive vertical coma of lower magnitude than the negative vertical coma of the unaided eyes. On the other hand, the improvement achieved in all visual function variables was the same for both contact lens designs (P ≥ .05).
CONCLUSIONS


The prismatic RGP contact lenses corrected higher levels of higher-order aberrations compared with the standard RGP contact lenses. However, both contact lens designs with the same refractive power were equally efficient at improving visual function.",2021,"Both contact lenses improved oblique primary astigmatism, defocus, vertical coma, coma-like, and RMS higher-order aberrations compared with the unaided eyes (P < .05).","['Keratoconic Eyes', 'Seventeen eyes of 17 keratoconus patients (34.6 ± 11.1 years']","['corneal RGP contact lens (KAKC', 'corneal prismatic RGP contact lenses', 'prismatic RGP contact lenses', 'standard rigid-gas-permeable contact lens as control and a prismatic RGP contact lens with a base-down prism of 1.6 prism diopters', 'Prismatic Rigid-gas-permeable Contact Lenses']","['oblique primary astigmatism, defocus, vertical coma, coma-like, and RMS higher-order aberrations', 'visual function', 'vertical coma and RMS higher-order aberrations', 'Ocular aberrations', 'visual function variables', 'high-contrast distance visual acuity, low-contrast distance visual acuity, and contrast sensitivity']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0444946', 'cui_str': 'Gas permeable'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0730376', 'cui_str': 'Gas-permeable contact lens'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1143779', 'cui_str': '2-amino-7-deazaadenine'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439487', 'cui_str': 'prism diopters'}]","[{'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}]",17.0,0.0508889,"Both contact lenses improved oblique primary astigmatism, defocus, vertical coma, coma-like, and RMS higher-order aberrations compared with the unaided eyes (P < .05).","[{'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Carballo-Alvarez', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Caballero-Magro', 'Affiliation': 'Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cortes-Escudero', 'Affiliation': 'Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carpena-Torres', 'Affiliation': 'Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001801']
1555,34509736,"Effects of the ""Unplugged"" school-based substance use prevention program in Nigeria: A cluster randomized controlled trial.","BACKGROUND


School-based programs are the most convenient interventions to tackle substance use among youth. ""Unplugged"" is a Social Influence universal school curriculum developed and tested in the ""EU-Dap"" project. In 2015, Nigeria implemented a large-scale project to promote healthy lifestyles in schools, families and communities. Within the project, the effectiveness of ""Unplugged"" was evaluated through a cluster randomized controlled trial.
METHODS


The program was adapted to the Nigerian context, assembling suggestions from monitoring forms and interviews, and performing fidelity checks on content and method. Thirty-two secondary schools were extracted from a list provided by the Federal Ministry of Education, and randomly allocated to intervention and control arms. A self-completed anonymous questionnaire was used for baseline and follow-up surveys. The analysis sample finally included 2685 pupils (mean age 14.2 years). Multilevel models were run to estimate program effects on prevalence of self-reported cigarettes, alcohol, and marijuana use. Mediation analysis was performed to identify possible mediators of program effect on alcohol use.
RESULTS


Unplugged significantly reduced the prevalence of recent alcohol use in intervention vs control pupils. The effect on prevalence of cigarette and marijuana use was not statistically significant. The program prevented progress and encouraged regress across stages of intensity of alcohol use. Negative beliefs, risk perceptions, and class climate mediated the effect of Unplugged on alcohol use.
CONCLUSIONS


Unplugged was effective in preventing alcohol use improving beliefs, class climate and risk perceptions among Nigerian students. The implementation of the program at a larger scale in the country should be supported.",2021,"CONCLUSIONS


Unplugged was effective in preventing alcohol use improving beliefs, class climate and risk perceptions among Nigerian students.","['Thirty-two secondary schools were extracted from a list provided by the Federal Ministry of Education', 'Nigerian students', 'Nigeria', '2685 pupils (mean age 14.2 years']","['Unplugged"" school-based substance use prevention program']","['prevalence of cigarette and marijuana use', 'prevalence of recent alcohol use', 'alcohol use improving beliefs, class climate and risk perceptions']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150358', 'cui_str': 'Substance use prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.00377026,"CONCLUSIONS


Unplugged was effective in preventing alcohol use improving beliefs, class climate and risk perceptions among Nigerian students.","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Vigna-Taglianti', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Torino, Regione Gonzole 10, 10043, Orbassano, Torino, Italy; Piedmont Centre for Drug Addiction Epidemiology, ASL TO3, Via Sabaudia 164, 10095, Grugliasco, Torino, Italy. Electronic address: federica.vignataglianti@unito.it.'}, {'ForeName': 'Emina', 'Initials': 'E', 'LastName': 'Mehanović', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Torino, Regione Gonzole 10, 10043, Orbassano, Torino, Italy; Piedmont Centre for Drug Addiction Epidemiology, ASL TO3, Via Sabaudia 164, 10095, Grugliasco, Torino, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Alesina', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Torino, Regione Gonzole 10, 10043, Orbassano, Torino, Italy; Piedmont Centre for Drug Addiction Epidemiology, ASL TO3, Via Sabaudia 164, 10095, Grugliasco, Torino, Italy.'}, {'ForeName': 'Ljiljana', 'Initials': 'L', 'LastName': 'Damjanović', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Torino, Regione Gonzole 10, 10043, Orbassano, Torino, Italy; Piedmont Centre for Drug Addiction Epidemiology, ASL TO3, Via Sabaudia 164, 10095, Grugliasco, Torino, Italy.'}, {'ForeName': 'Akanidomo', 'Initials': 'A', 'LastName': 'Ibanga', 'Affiliation': 'United Nations Office on Drugs and Crime, Project Office, NDLEA Headquarters, 4 Onilegbale Road, Ikoyi, Lagos, Nigeria.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Pwajok', 'Affiliation': 'University of Jos, P.M.B. 2084, 93001, Jos, Nigeria.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Prichard', 'Affiliation': 'United Nations Office on Drugs and Crime, Project Office, NDLEA Headquarters, 4 Onilegbale Road, Ikoyi, Lagos, Nigeria.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'van der Kreeft', 'Affiliation': 'Faculty of Education, Health and Social Work, University College Ghent, Valentin Vaerwyckweg 1, 9000, Ghent, Belgium.'}, {'ForeName': 'Harsheth Kaur', 'Initials': 'HK', 'LastName': 'Virk', 'Affiliation': 'United Nations Office on Drugs and Crime, Project Office, NDLEA Headquarters, 4 Onilegbale Road, Ikoyi, Lagos, Nigeria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108966']
1556,34507259,Impact of exemplar education program on the professional commitment of nursing students: A quasi-experimental study.,"BACKGROUND


High attrition rate and nursing workforce shortage have been a prevailing world challenge. Professional commitment is a known key factor for attracting and retaining the nursing workforce.
OBJECTIVE


To design, implement and evaluate the impact of a one-week structured education program, underpinned by the exemplar education strategy, on the professional commitment of undergraduate nursing students.
DESIGN


A quasi-experimental study was designed with pre- and post-intervention measurements. The intervention was a structured, four module education program underpinned by the exemplar education strategy.
SETTING


Department of Nursing, Qianjiang College, Hangzhou Normal University, Zhejiang, China.
PARTICIPANTS


152 third-year nursing students who attended the education program and consented to participate were enrolled in the research.
METHODS


The intervention, the education program, was delivered over 16 h in one week of an 18-week semester. It was sequenced in four modules: expert lectures (3 h each), visiting a hospital (3 h), alumni salon (3 h), and submitting a reflection report (4 h). Professional commitment was measured by the Nursing Professional Commitment Scale (NPCS) administered both pre- and post-intervention.
RESULTS


The total professional commitment measurement score was significantly improved after the intervention. There were statistically significant differences before and after intervention in the four dimensions of professional commitment, namely, belief in goals and values, willingness to make an effort, desire to stay in the profession, and intrinsic positive value of work.
CONCLUSION


The one-week professional education program underpinned by the exemplar education strategy effectively improved the level of professional commitment of the undergraduate nursing students. The program can be transferred into the curriculum to improve nursing students' professional commitment. The methodology can be applied in other aspects of nursing professional development.",2021,"There were statistically significant differences before and after intervention in the four dimensions of professional commitment, namely, belief in goals and values, willingness to make an effort, desire to stay in the profession, and intrinsic positive value of work.
","['152 third-year nursing students who attended the education program and consented to participate were enrolled in the research', 'Department of Nursing, Qianjiang College, Hangzhou Normal University, Zhejiang, China', 'nursing students', 'undergraduate nursing students']",['exemplar education program'],"['level of professional commitment', 'professional commitment, namely, belief in goals and values, willingness to make an effort, desire to stay in the profession, and intrinsic positive value of work', 'total professional commitment measurement score', 'Nursing Professional Commitment Scale (NPCS']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",,0.0190395,"There were statistically significant differences before and after intervention in the four dimensions of professional commitment, namely, belief in goals and values, willingness to make an effort, desire to stay in the profession, and intrinsic positive value of work.
","[{'ForeName': 'Liqi', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Nursing Department, Qianjiang College, Hangzhou Normal University, Hangzhou, Zhejiang, China. Electronic address: 51358077@qq.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Centre for Digital Transformation, School of Computing and Information Technology, Universtiy of Wollongong, Wollongong, NSW 2522, Australia. Electronic address: ping@uow.edu.au.'}]",Nurse education today,['10.1016/j.nedt.2021.105118']
1557,34506311,Age-related Opioid Exposure in Trauma: A Secondary Analysis of the Multimodal Analgesia Strategies for Trauma (MAST) Randomized Trial.,"OBJECTIVE


Evaluate the effect of age on opioid consumption after traumatic injury.
SUMMARY BACKGROUND DATA


Older trauma patients receive fewer opioids due to decreased metabolism and increased complications, but adequacy of pain control is unknown. We hypothesized that older trauma patients require fewer opioids to achieve adequate pain control.
METHODS


A secondary analysis of the multimodal analgesia strategies for trauma Trial evaluating the effectiveness of 2 multimodal pain regimens in 1561 trauma patients aged 16 to 96 was performed. Older patients (≥55 years) were compared to younger patients. Median daily oral morphine milligram equivalents (MME) consumption, average numeric rating scale pain scores, complications, and death were assessed. Multivariable analyses were performed.
RESULTS


Older patients (n = 562) had a median age of 68 years (interquartile range 61-78) compared to 33 (24-43) in younger patients. Older patients had lower injury severity scores (13 [9-20] vs 14 [9-22], P = 0.004), lower average pain scores (numeric rating scale 3 [1-4] vs 4 [2-5], P < 0.001), and consumed fewer MME/day (22 [10-45] vs 52 [28-78], P < 0.001). The multimodal analgesia strategies for trauma multi-modal pain regimen was effective at reducing opioid consumption at all ages. Additionally, on multivariable analysis including pain score adjustment, each decade age increase after 55 years was associated with a 23% reduction in MME/day consumed.
CONCLUSIONS


Older trauma patients required fewer opioids than younger patients with similar characteristics and pain scores. Opioid dosing for post-traumatic pain should consider age. A 20 to 25% dose reduction per decade after age 55 may reduce opioid exposure without altering pain control.",2021,"Older patients had lower injury severity scores (13 [9-20] vs 14 [9-22], P = 0.004), lower average pain scores (numeric rating scale 3 [1-4] vs 4 [2-5], P < 0.001), and consumed fewer MME/day (22 [10-45] vs 52 [28-78], P < 0.001).","['Age-related Opioid Exposure in Trauma', '1561 trauma patients aged 16 to 96 was performed', 'older trauma patients', 'Older patients (n = 562) had a median age of 68\u200ayears (interquartile range 61-78) compared to 33 (24-43) in younger patients', 'Older patients (≥55\u200ayears', 'Older trauma patients', 'Trauma (MAST']","['Opioid', 'multimodal pain regimens']","['injury severity scores', 'Median daily oral morphine milligram equivalents (MME) consumption, average numeric rating scale pain scores, complications, and death', 'pain score adjustment', 'pain scores', 'average pain scores (numeric rating scale', 'opioid consumption']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332666', 'cui_str': 'Old injury'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0282185', 'cui_str': 'Antishock wear system trousers'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",,0.177249,"Older patients had lower injury severity scores (13 [9-20] vs 14 [9-22], P = 0.004), lower average pain scores (numeric rating scale 3 [1-4] vs 4 [2-5], P < 0.001), and consumed fewer MME/day (22 [10-45] vs 52 [28-78], P < 0.001).","[{'ForeName': 'Gabrielle E', 'Initials': 'GE', 'LastName': 'Hatton', 'Affiliation': 'Department of Surgery, Division of Acute Care Surgery, McGovern Medical School at UTHealth, Houston, Texas.'}, {'ForeName': 'Heather R', 'Initials': 'HR', 'LastName': 'Kregel', 'Affiliation': 'Department of Surgery, Division of Acute Care Surgery, McGovern Medical School at UTHealth, Houston, Texas.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, Texas.'}, {'ForeName': 'Thaddeus J', 'Initials': 'TJ', 'LastName': 'Puzio', 'Affiliation': 'Department of Surgery, Division of Acute Care Surgery, McGovern Medical School at UTHealth, Houston, Texas.'}, {'ForeName': 'Sasha D', 'Initials': 'SD', 'LastName': 'Adams', 'Affiliation': 'Department of Surgery, Division of Acute Care Surgery, McGovern Medical School at UTHealth, Houston, Texas.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': 'Department of Surgery, Division of Acute Care Surgery, McGovern Medical School at UTHealth, Houston, Texas.'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'Department of Surgery, Division of Acute Care Surgery, McGovern Medical School at UTHealth, Houston, Texas.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Harvin', 'Affiliation': 'Department of Surgery, Division of Acute Care Surgery, McGovern Medical School at UTHealth, Houston, Texas.'}]",Annals of surgery,['10.1097/SLA.0000000000005065']
1558,34498484,"Rationale and design of a prospective, multicenter, randomized controlled trial of postoperative venous thromboembolism prophylaxis in Chinese adult patients with inguinal hernia (CHAT-3 trial).","BACKGROUND


Venous thromboembolism (VTE) is one of the most common causes of preventable harm for patients in hospitals. Nearly half of all VTE events was estimated to occur after surgical procedure. The Caprini risk score is the most extensively used risk assessment tool in predicting postoperative VTE, which is too complicate for surgeons to use properly in their clinical practice.
METHODS


The CHAT-3 trial will be a prospective, multicenter, randomized, parallel-group trial, which is designed to identify patients at moderate or high risk of VTE after inguinal hernia surgery using the previously established three-factor model, and to use low molecular weight heparin (LMWH) for VTE prevention, in comparison to the current routine assessment and practice used in those patients. Totally, 1,008 patients planned to undergo inguinal hernia surgery will be enrolled, with cluster randomization at 1:1 ratio into intervention arm and control arm. The primary outcomes are the accordance of perioperative VTE prophylaxis based on current guidelines and the rate of pharmacological prophylaxis for VTE. The secondary outcomes are the occurrences of perioperative VTE, major bleeding, mortality of patients after inguinal hernia surgery, and trend of D-dimer during the follow-up period.
DISCUSSION


This study will create evidence that whether the administration based on a simple model is of efficacy and safety for VTE prophylaxis among Chinese patients underwent inguinal hernia surgery.
TRIAL REGISTRATION


The CHAT-3 trial (Trial registration number: ChiCTR2000033769).",2021,"The secondary outcomes are the occurrences of perioperative VTE, major bleeding, mortality of patients after inguinal hernia surgery, and trend of D-dimer during the follow-up period.
","['Chinese patients underwent inguinal hernia surgery', 'Chinese adult patients with inguinal hernia (CHAT-3 trial', '1,008 patients planned to undergo inguinal hernia surgery will be enrolled, with cluster randomization at 1:1 ratio into intervention arm and control arm', 'patients in hospitals', 'patients at moderate or high risk of VTE after inguinal hernia surgery']",['postoperative venous thromboembolism prophylaxis'],"['Caprini risk score', 'occurrences of perioperative VTE, major bleeding, mortality of patients after inguinal hernia surgery, and trend of D-dimer', 'accordance of perioperative VTE prophylaxis based on current guidelines and the rate of pharmacological prophylaxis for VTE']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0199242', 'cui_str': 'Anticoagulant prophylaxis'}]","[{'cui': 'C4523833', 'cui_str': 'Caprini risk score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0199242', 'cui_str': 'Anticoagulant prophylaxis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]",,0.105436,"The secondary outcomes are the occurrences of perioperative VTE, major bleeding, mortality of patients after inguinal hernia surgery, and trend of D-dimer during the follow-up period.
","[{'ForeName': 'Jin-Xin', 'Initials': 'JX', 'LastName': 'Cao', 'Affiliation': 'Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hang-Yu', 'Initials': 'HY', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Guang-Yong', 'Initials': 'GY', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, The Fourth Affiliated Hospital, China Medical University, Shenyang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Che', 'Affiliation': 'NHC Key Lab of Reproduction Regulation (Shanghai Institute for Biomedical and Pharmaceutical Technologies), Fudan University, Shanghai, China.'}, {'ForeName': 'Zhi-Chun', 'Initials': 'ZC', 'LastName': 'Gu', 'Affiliation': 'Department of Pharmacy, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ming-Gang', 'Initials': 'MG', 'LastName': 'Wang', 'Affiliation': 'Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of palliative medicine,['10.21037/apm-21-1594']
1559,34498475,Resistance and aerobic exercise intervention during chemotherapy in patients with metastatic cancer: a pilot study in South Korea.,"BACKGROUND


We investigated the feasibility and safety of an exercise intervention in patients with metastatic solid cancer.
METHODS


Patients scheduled to receive first-line chemotherapy for metastatic cancer with a life expectancy of ≥4 months, no brain metastases, and no high risk of fracture were recruited to participate in a 12-week, combined resistance and aerobic exercise program consisting of supervised, hospital-based (2×/week) and home-based training (3×/week) during palliative chemotherapy. Feasibility and safety of the exercise intervention were the primary outcomes. The secondary outcomes were skeletal muscle mass and strength, functional capacity, quality of life (QoL), and fatigue.
RESULTS


Nineteen patients were enrolled in this pilot study. Five patients withdrew consent before the exercise intervention due to fear of exacerbating cancer-related symptoms (n=2), transportation issues (n=2), and unknown reasons (n=1). Ten patients (71.4%) completed the 12-week exercise program. Mean attendance rate of the supervised exercise sessions was 64.9% (range, 16.7-95.8%). No adverse events or skeletal complications occurred during the supervised exercise sessions. Among participants, there were no significant changes in muscle area at the third lumbar level (mean change =-0.7 cm2, P=0.869) or appendicular skeletal muscle mass (mean change =0.1 kg, P=0.661). The overall QoL assessed using the Functional Assessment of Cancer Therapy-General significantly improved post-exercise interventions (P=0.037). There were significant improvements in the QoL subdomains of emotional well-being and physical, social, and cognitive functions.
CONCLUSIONS


Exercise interventions are feasible and safe in patients with metastatic cancer. Exercise interventions can improve QoL and prevent skeletal muscle loss during palliative chemotherapy.",2021,"There were significant improvements in the QoL subdomains of emotional well-being and physical, social, and cognitive functions.
","['Nineteen patients', 'for metastatic cancer with a life expectancy of ≥4 months, no brain metastases, and no high risk of fracture were recruited to participate in a 12-week', 'patients with metastatic cancer', 'patients with metastatic solid cancer', 'Patients scheduled to']","['receive first-line chemotherapy', 'Exercise interventions', 'Resistance and aerobic exercise intervention', 'combined resistance and aerobic exercise program consisting of supervised, hospital-based (2×/week) and home-based training (3×/week) during palliative chemotherapy', 'exercise intervention']","['skeletal muscle mass and strength, functional capacity, quality of life (QoL), and fatigue', 'Feasibility and safety', 'overall QoL assessed using the Functional Assessment of Cancer Therapy-General significantly improved post-exercise interventions', 'adverse events or skeletal complications', 'QoL subdomains of emotional well-being and physical, social, and cognitive functions', 'skeletal muscle loss', 'Mean attendance rate', 'appendicular skeletal muscle mass', 'muscle area at the third lumbar level']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",19.0,0.0385645,"There were significant improvements in the QoL subdomains of emotional well-being and physical, social, and cognitive functions.
","[{'ForeName': 'Joo-Hwan', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.'}, {'ForeName': 'Ki Deok', 'Initials': 'KD', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.'}, {'ForeName': 'Jin-Hong', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ""Clinical Rehabilitation Research Center, Korea Worker's Compensation & Welfare Service, Incheon Hospital, Incheon, South Korea.""}, {'ForeName': 'Young Saing', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.'}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.'}, {'ForeName': 'Hee Kyung', 'Initials': 'HK', 'LastName': 'Ahn', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.'}, {'ForeName': 'Inkeun', 'Initials': 'I', 'LastName': 'Park', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.'}, {'ForeName': 'Sun Jin', 'Initials': 'SJ', 'LastName': 'Sym', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.'}]",Annals of palliative medicine,['10.21037/apm-21-1432']
1560,34514842,LVS-HARMED Risk Score for Incident Heart Failure in Patients With Atrial Fibrillation Who Present to the Emergency Department: Data from a World-Wide Registry.,"Background Heart failure (HF) is a common complication to atrial fibrillation (AF), leading to rehospitalization and death. Early identification of patients with AF at risk for HF might improve outcomes. We aimed to derive a score to predict 1-year risk of new-onset HF after an emergency department (ED) visit with AF. Methods and Results The RE-LY AF (Randomized Evaluation of Long-Term Anticoagulant Therapy) registry enrolled patients with AF presenting to an ED in 47 countries, and followed them for a year. The end point was HF hospitalization and/or HF death. Among 15 400 ED patients, 9765 had no prior HF (mean age, 64.9±14.9 years). Within 1 year, new-onset HF developed in 6.8% of patients, of whom 21% died of HF. Independent predictors of HF included left ventricular hypertrophy (odds ratio [OR], 1.47; 95% CI, 1.19-1.82), valvular heart disease (OR, 1.55; 95% CI, 1.18-2.04), smoking (OR, 1.42; 95% CI, 1.12-1.78), height (OR, 0.93; 95% CI, 0.90-0.95 per 3 cm), age (OR, 1.11; 95% CI, 1.07-1.15 per 5 years), rheumatic heart disease (OR, 1.77, 95% CI, 1.24-2.51), prior myocardial infarction (OR, 1.85; 95% CI, 1.45-2.36), remaining in AF at ED discharge (OR, 1.86; 95% CI, 1.46-2.36), and diabetes (OR, 1.33; 95% CI, 1.09-1.64). A continuous risk prediction score (LVS-HARMED [left ventricular, valvular heart disease, smoking or other tobacco use, height, age, rheumatic heart disease, myocardial infarction, emergency department discharge rhythm, and diabetes]) had good discrimination (C statistic, 0.735; 95% CI, 0.716-0.755). Validation was conducted internally using bootstrapping (optimism-corrected C statistic, 0.705) and externally (C statistic, 0.699). The 1-year incidence of HF hospitalization and/or HF death across quartile groups of the score was 1.1%, 4.5%, 6.9%, and 14.4%, respectively. LVS-HARMED also predicted incident stroke (C statistic, 0.753; 95% CI, 0.728-0.778). Conclusions The LVS-HARMED score predicts new-onset HF after an ED visit for AF. Preventative strategies should be considered in patients with high LVS-HARMED HF risk.",2021,"LVS-HARMED also predicted incident stroke (C statistic, 0.753; 95% CI, 0.728-0.778).","['patients with high LVS-HARMED HF risk', 'enrolled patients with AF presenting to an ED in 47 countries, and followed them for a year', 'patients with AF at risk for HF', 'Patients With Atrial Fibrillation', 'Among 15\xa0400 ED patients, 9765 had no prior HF (mean age, 64.9±14.9\xa0years']",[],"['left ventricular hypertrophy', 'rheumatic heart disease', 'HF hospitalization and/or HF death', 'prior myocardial infarction', 'valvular heart disease', '1-year incidence of HF hospitalization and/or HF death', 'continuous risk prediction score (LVS-HARMED [left ventricular, valvular heart disease, smoking or other tobacco use, height, age, rheumatic heart disease, myocardial infarction, emergency department discharge rhythm, and diabetes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3662281', 'cui_str': 'At risk for heart failure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}, {'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0018824', 'cui_str': 'Heart valve disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",15400.0,0.295228,"LVS-HARMED also predicted incident stroke (C statistic, 0.753; 95% CI, 0.728-0.778).","[{'ForeName': 'Linda S B', 'Initials': 'LSB', 'LastName': 'Johnson', 'Affiliation': 'Department of Clinical Physiology Skåne University Hospital Department of Clinical Sciences Lund University Malmö Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology Uppsala University Uppsala Sweden.'}, {'ForeName': 'Tyler W', 'Initials': 'TW', 'LastName': 'Barrett', 'Affiliation': 'Department of Emergency Medicine Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Candace D', 'Initials': 'CD', 'LastName': 'McNaughton', 'Affiliation': 'Department of Emergency Medicine Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Wong', 'Affiliation': 'Population Health Research Institute McMaster University Hamilton Onatrio Canada.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'McIntyre', 'Affiliation': 'Population Health Research Institute McMaster University Hamilton Onatrio Canada.'}, {'ForeName': 'Clifford L', 'Initials': 'CL', 'LastName': 'Freeman', 'Affiliation': 'Department of Emergency Medicine Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Murphy', 'Affiliation': 'Department of Emergency Medicine Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Engström', 'Affiliation': 'Department of Clinical Physiology Skåne University Hospital Department of Clinical Sciences Lund University Malmö Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ezekowitz', 'Affiliation': 'Sidney Kimmel Medical College Bryn Mawr HospitalLankenau Heart Center Wynnewood PA.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute McMaster University Hamilton Onatrio Canada.'}, {'ForeName': 'Lizhen', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Population Health Research Institute McMaster University Hamilton Onatrio Canada.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Nakamya', 'Affiliation': 'Population Health Research Institute McMaster University Hamilton Onatrio Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': 'Population Health Research Institute McMaster University Hamilton Onatrio Canada.'}, {'ForeName': 'Shrikant I', 'Initials': 'SI', 'LastName': 'Bangdiwala', 'Affiliation': 'Population Health Research Institute McMaster University Hamilton Onatrio Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute McMaster University Hamilton Onatrio Canada.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute McMaster University Hamilton Onatrio Canada.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017735']
1561,34514815,Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials.,"BACKGROUND In acute heart failure (AHF), systolic blood pressure (SBP) is an important clinical variable. This study assessed the association between SBP and short-term and long-term outcomes in a large cohort of patients with AHF. METHODS AND RESULTS This is an analysis of 4 randomized controlled trials investigating serelaxin versus placebo in patients admitted with AHF and SBPs from 125 to 180 mm Hg. Outcomes were 180-day all-cause mortality and a composite end point of all-cause mortality, worsening heart failure, or hospital readmission for heart failure the first 14 days. Left ventricular ejection fraction (LVEF) was examined as LVEF<40% and LVEF≥40%. Multivariable Cox regression models were adjusted for known confounders of outcomes in AHF. A total of 10 533 patients with a mean age of 73 (±12) years and a mean SBP of 145 (±7) mm Hg were included. LVEF was assessed in 9863 patients (93%); 4737 patients (45%) had LVEF<40%. Increasing SBP was inversely associated with 180-day mortality (adjusted hazard ratio [HR adjusted ], 0.93; 95% CI, 0.89-0.98;  P =0.008 per 10 mm Hg increase) and with the composite end point (HR adjusted , 0.90; 95% CI, 0.85-0.94;  P <0.001 per 10 mm Hg increase). A significant interaction with LVEF was observed, revealing that SBP was not associated with mortality in patients with LVEF≥40% (HR adjusted , 0.98; 95% CI, 0.91-1.04; per 10 mm Hg increase), but was strongly associated with increased mortality in LVEF<40% (HR adjusted , 0.84; 95% CI, 0.77-0.92; per 10 mm Hg increase). CONCLUSIONS Elevated SBP is associated with favorable short-term and long-term outcomes in patients with AHF. In our predefined subgroup analysis, we found that baseline SBP was not associated with mortality in LVEF≥40%, but was strongly associated with mortality in patients with LVEF<40%.",2021,"Increasing SBP was inversely associated with 180-day mortality (adjusted hazard ratio [HR adjusted ], 0.93; 95% CI, 0.89-0.98;  P =0.008 per 10 mm ","['patients admitted with AHF and SBPs from 125 to 180\xa0mm', '9863 patients (93', 'patients with AHF', 'A total of 10\xa0533 patients with a mean age of 73 (±12) years and a mean SBP of 145 (±7) mm', 'Patients Admitted With Acute Heart Failure', '4737 patients (45%) had LVEF<40']",['serelaxin versus placebo'],"['mortality', 'Increasing SBP', '180-day all-cause mortality and a composite end point of all-cause mortality, worsening heart failure, or hospital readmission for heart failure the first 14\xa0days', 'LVEF', 'Systolic Blood Pressure and Outcome', '180-day mortality', 'Left ventricular ejection fraction (LVEF', 'systolic blood pressure (SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C2733340', 'cui_str': 'Ventricular ejection'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0277884', 'cui_str': 'Increased systolic arterial pressure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",10533.0,0.523669,"Increasing SBP was inversely associated with 180-day mortality (adjusted hazard ratio [HR adjusted ], 0.93; 95% CI, 0.89-0.98;  P =0.008 per 10 mm ","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Grand', 'Affiliation': 'Department of Cardiology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Miger', 'Affiliation': 'Department of Cardiology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sajadieh', 'Affiliation': 'Department of Cardiology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Cardiology Hillerød Hospital Hillerød Denmark.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Ertl', 'Affiliation': 'Comprehensive Heart Failure Center University Hospital Würzburg Germany.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López-Sendón', 'Affiliation': 'Department of Cardiology Hospital La PazIdiPazUniversidad Autonoma de Madrid Madrid Spain.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Pietro Maggioni', 'Affiliation': 'Department of Cardiology Hospital La PazIdiPazUniversidad Autonoma de Madrid Madrid Spain.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Department of Cardiology University of CaliforniaSan FranciscoSan Francisco VA Medical Center Cardiology San Francisco CA.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiovascular Medicine Kawaguchi Cardiovascular and Respiratory Hospital Saitama Japan.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gimpelewicz', 'Affiliation': 'Novartis Pharma AG Basel Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology Department of Medical and Surgical Specialties Cardiothoracic Department Radiological Sciences and Public Health Civil HospitalsUniversity of Brescia Brescia Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Holbro', 'Affiliation': 'Novartis Pharma AG Basel Switzerland.'}, {'ForeName': 'Olav W', 'Initials': 'OW', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.022288']
1562,34523232,Phase I/II study of biweekly nab-paclitaxel in patients with platinum-pretreated non-small cell lung cancer: NJLCG1402.,"BACKGROUND


NJLCG1402 was a phase I/II trial investigating biweekly nanoparticle albumin-bound paclitaxel (nab-PTX) in patients with advanced non-small cell lung cancer (NSCLC).
METHODS


The study included patients aged ≥20 years with previously treated NSCLC. Nab-PTX (100-150 mg/m 2  ) was administered biweekly in a 28-day cycle. The phase I portion was performed to determine the recommended phase II dose of nab-PTX. In the phase II portion, the primary endpoint was the objective response rate. Secondary endpoints were disease control rate, progression-free survival, overall survival, and safety.
RESULTS


A total of 15 patients received biweekly nab-PTX (100-150 mg/m 2  ) and 12 patients in phase II were treated with 150 mg/m 2  . In the phase I portion, 150 mg/m 2  was determined as the recommended dose. Among those treated with 150 mg/m 2  , the objective response rate was 22%, and the median progression-free and overall survival was 3.6 and 11.2 months, respectively. Adverse events grade ≥3 were observed in 39% of patients.
CONCLUSIONS


Biweekly nab-PTX monotherapy was well tolerated and exhibited favorable antitumor activity in patients with previously treated NSCLC.",2021,"Adverse events grade ≥3 were observed in 39% of patients.
","['patients with previously treated NSCLC', 'patients aged ≥20\u2009years with previously treated NSCLC', '15 patients received', 'patients with platinum-pretreated non-small cell lung cancer', 'patients with advanced non-small cell lung cancer (NSCLC']","['nanoparticle albumin-bound paclitaxel (nab-PTX', 'Biweekly nab-PTX monotherapy', 'Nab-PTX', 'biweekly nab-PTX', 'NJLCG1402', 'biweekly nab-paclitaxel']","['disease control rate, progression-free survival, overall survival, and safety', 'tolerated and exhibited favorable antitumor activity', 'median progression-free and overall survival', 'objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",15.0,0.15969,"Adverse events grade ≥3 were observed in 39% of patients.
","[{'ForeName': 'Eisaku', 'Initials': 'E', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Respiratory Medicine, Hirosaki University Hospital, Hirosaki, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Respiratory Medicine, Sendai Kosei Hospital, Sendai, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, JCHO Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Thoracic Surgery, Omagari Kosei Medical Center, Omagari, Japan.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Morita', 'Affiliation': 'Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Jingu', 'Affiliation': 'Department of Respiratory Medicine, Saka General Hospital, Shiogama, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Kuda', 'Affiliation': 'Department of Respiratory Medicine, Naha City Hospital, Naha, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Gamou', 'Affiliation': 'Department of Respiratory Medicine, Kesennuma City Hospital, Kesennuma, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Saito', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Department of Palliative Medicine, Tohoku University School of Medicine, Sendai, Japan.'}]",Thoracic cancer,['10.1111/1759-7714.14149']
1563,34521417,Effects of canagliflozin on NT-proBNP stratified by left ventricular diastolic function in patients with type 2 diabetes and chronic heart failure: a sub analysis of the CANDLE trial.,"BACKGROUND


Identification of the effective subtypes of treatment for heart failure (HF) is an essential topic for optimizing treatment of the disorder. We hypothesized that the beneficial effect of SGLT2 inhibitors (SGLT2i) on the levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) might depend on baseline diastolic function. To elucidate the effects of SGLT2i in type 2 diabetes mellitus (T2DM) and chronic HF we investigated, as a post-hoc sub-study of the CANDLE trial, the effects of canagliflozin on NT-proBNP levels from baseline to 24 weeks, with the data stratified by left ventricular (LV) diastolic function at baseline.
METHODS


Patients (n = 233) in the CANDLE trial were assigned randomly to either an add-on canagliflozin (n = 113) or glimepiride treatment groups (n = 120). The primary endpoint was a comparison between the two groups of the changes from baseline to 24 weeks in NT-pro BNP levels, stratified according to baseline ventricular diastolic function.
RESULTS


The change in the geometric mean of NT-proBNP level from baseline to 24 weeks was 0.98 (95% CI 0.89-1.08) in the canagliflozin group and 1.07 (95% CI 0.97-1.18) in the glimepiride group. The ratio of change with canagliflozin/glimepiride was 0.93 (95% CI 0.82-1.05). Responder analyses were used to investigate the response of an improvement in NT-proBNP levels. Although the subgroup analyses for septal annular velocity (SEP-e') showed no marked heterogeneity in treatment effect, the subgroup with an SEP-e' < 4.7 cm/s indicated there was an association with lower NT-proBNP levels in the canagliflozin group compared with that in the glimepiride group (ratio of change with canagliflozin/glimepiride (0.83, 95% CI 0.66-1.04).
CONCLUSIONS


In the subgroup with a lower LV diastolic function, canagliflozin showed a trend of reduced NT-pro BNP levels compared to that observed with glimepiride. This study suggests that the beneficial effects of canagliflozin treatment may be different in subgroups classified by the severity of LV diastolic dysfunction.",2021,The change in the geometric mean of NT-proBNP level from baseline to 24 weeks was 0.98 (95% CI 0.89-1.08) in the canagliflozin group and 1.07 (95% CI 0.97-1.18) in the glimepiride group.,"['Patients (n\u2009=\u2009233) in the CANDLE trial', 'patients with type 2 diabetes and chronic heart failure']","['glimepiride', 'SGLT2i', 'canagliflozin', 'canagliflozin/glimepiride', 'SGLT2 inhibitors (SGLT2i']","['lower NT-proBNP levels', 'geometric mean of NT-proBNP level', 'reduced NT-pro BNP levels', 'septal annular velocity', 'NT-pro BNP levels, stratified according to baseline ventricular diastolic function', 'NT-proBNP levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1850568', 'cui_str': 'Nakajo-Nishimura syndrome'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.186903,The change in the geometric mean of NT-proBNP level from baseline to 24 weeks was 0.98 (95% CI 0.89-1.08) in the canagliflozin group and 1.07 (95% CI 0.97-1.18) in the glimepiride group.,"[{'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Kusunose', 'Affiliation': 'Department of Cardiovascular Medicine, Tokushima University Hospital, 2-50-1 Kuramoto, Tokushima, Japan. kusunosek@tokushima-u.ac.jp.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Dohi', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Shiina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Devision of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kida', 'Affiliation': 'Department of Pharmacology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Eguchi', 'Affiliation': 'Department of General Internal Medicine, Saitama Red Cross Hospital, Saitama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Teragawa', 'Affiliation': 'Department of Cardiovascular Medicine, JR Hiroshima Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yasuchika', 'Initials': 'Y', 'LastName': 'Takeishi', 'Affiliation': 'Department of Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Ohte', 'Affiliation': 'Department of Cardiovascular Medicine, Nagoya City University East Medical Center, Nagoya, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Yamada', 'Affiliation': 'Department of Community Medicine for Cardiology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sata', 'Affiliation': 'Department of Cardiovascular Medicine, Tokushima University Hospital, 2-50-1 Kuramoto, Tokushima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular diabetology,['10.1186/s12933-021-01380-w']
1564,34526745,The Effect of Mindfulness on Quality of Life among Women with Premature Ovarian Insufficiency: A Randomized Clinical Trial.,"Background


Premature ovarian insufficiency may impair the quality of life and expose women to disorders such as cardiovascular disease, osteoporosis, and depression. This study aimed to evaluate the effect of mindfulness on the quality of life in women with premature ovarian insufficiency.
Methods


This study involved 62 women who were randomly allocated into two groups of mindfulness and control. The mindfulness group received eight sessions of training. A demographic questionnaire, menopause-specific quality of life and a checklist (for assessing hot flashes) were used to collect the data. The quality of life, frequency, and intensity of hot flashes were measured before the intervention, immediately, and 3 months after it. Independent  t -test, the Chi-square test, and the repeated measure test were used for data analysis.
Results


The scores of quality of life dropped from 95.6 ± 9.77 at baseline to 77.32 ± 7.93 after intervention and 48.32 ± 4.96 at 3-months follow-up in the mindfulness group but rose from 99.5 ± 16.1 at baseline to 100.2 ± 15.33 after intervention, and 102.6 ± 14.9 3-months after it in the control group,  P  < 0.001. The scores of vasomotor, psychological, physical, and sexual domains also improved significantly in the mindfulness group compared to the control group. The mean of hot flashes in the mindfulness group was 1.30 ± 0.69 and decreased to 1.1 ± 0.56 and 0.66 ± 0.58 immediately and in 3 months after intervention, respectively. The frequency of hot flashes was 14.74 ± 10.4 per week before intervention in the mindfulness group which reduced to 12.38 ± 8.66 and 6.74 ± 6.34 per week, immediately and 3 months after the intervention, while in the control group, there was an increase in the frequency of hot flashes ( P  < 0.0001).
Conclusion


According to the results of this study, mindfulness could improve quality of life and reduce hot flashes, so mindfulness training for women with premature ovarian insufficiency is strongly recommended.",2021,"The frequency of hot flashes was 14.74 ± 10.4 per week before intervention in the mindfulness group which reduced to 12.38 ± 8.66 and 6.74 ± 6.34 per week, immediately and 3 months after the intervention, while in the control group, there was an increase in the frequency of hot flashes ( P  < 0.0001).
","['62 women who were randomly allocated into two groups of mindfulness and control', 'Women with Premature Ovarian Insufficiency', 'women with premature ovarian insufficiency']",['Mindfulness'],"['quality of life and reduce hot flashes', 'mean of hot flashes', 'Quality of Life', 'scores of vasomotor, psychological, physical, and sexual domains', 'quality of life', 'demographic questionnaire, menopause-specific quality of life and a checklist (for assessing hot flashes', 'scores of quality of life', 'quality of life, frequency, and intensity of hot flashes', 'frequency of hot flashes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",62.0,0.0354047,"The frequency of hot flashes was 14.74 ± 10.4 per week before intervention in the mindfulness group which reduced to 12.38 ± 8.66 and 6.74 ± 6.34 per week, immediately and 3 months after the intervention, while in the control group, there was an increase in the frequency of hot flashes ( P  < 0.0001).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Pyri', 'Affiliation': 'Department of Midwifery, Menopause Andropause Research Centre, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Abedi', 'Affiliation': 'Department of Midwifery, Menopause Andropause Research Centre, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Maraghi', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Maryam Gholamzadeh', 'Initials': 'MG', 'LastName': 'Jefreh', 'Affiliation': 'Department of Counseling, Ahvaz Branch, Islamic Azad University, Ahvaz, Iran.'}]",Journal of mid-life health,['10.4103/jmh.JMH_66_20']
1565,34526698,Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis.,"The emergence of SARS-CoV-2 variants of concern (VOCs) and variants of interest (VOIs) with decreased susceptibility to neutralization has generated interest in assessments of booster doses and variant-specific vaccines. Clinical trial participants who received a two-dose primary series of the COVID-19 vaccine mRNA-1273 approximately 6 months earlier entered an open-label phase 2a study ( NCT04405076 ) to evaluate the primary objectives of safety and immunogenicity of a single booster dose of mRNA-1273 or variant-modified mRNAs, including multivalent mRNA-1273.211. As the trial is currently ongoing, this exploratory interim analysis includes preliminary descriptive results only of four booster groups (n = 20 per group). Immediately before the booster dose, neutralizing antibodies against wild-type D614G virus had waned (P < 0.0001) relative to peak titers against wild-type D614G measured 1 month after the primary series, and neutralization titers against B.1.351 (Beta), P.1 (Gamma) and B.1.617.2 (Delta) VOCs were either low or undetectable. Both the mRNA-1273 booster and variant-modified boosters were safe and well-tolerated. All boosters, including mRNA-1273, numerically increased neutralization titers against the wild-type D614G virus compared to peak titers against wild-type D614G measured 1 month after the primary series; significant increases were observed for mRNA-1273 and mRNA-1273.211 (P < 0.0001). In addition, all boosters increased neutralization titers against key VOCs and VOIs, including B.1.351, P.1. and B.1.617.2, that were statistically equivalent to peak titers measured after the primary vaccine series against wild-type D614G virus, with superior titers against some VOIs. This trial is ongoing.",2021,"All boosters, including mRNA-1273, numerically increased neutralization titers against the wild-type D614G virus compared to peak titers against wild-type D614G measured 1 month after the primary series; significant increases were observed for mRNA-1273 and mRNA-1273.211 (P < 0.0001).","['healthy adults', 'Clinical trial participants who received a two-dose primary series of the']","['mRNA-1273 or variant-modified mRNAs, including multivalent mRNA-1273.211', 'COVID-19 vaccine mRNA-1273', 'SARS-CoV-2 variant mRNA vaccine boosters']","['neutralization titers against B.1.351 (Beta), P.1 (Gamma) and B.1.617.2 (Delta', 'peak titers', 'safe and well-tolerated', 'neutralization titers against key VOCs and VOIs', 'neutralization titers']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205549', 'cui_str': 'Series'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",,0.0907645,"All boosters, including mRNA-1273, numerically increased neutralization titers against the wild-type D614G virus compared to peak titers against wild-type D614G measured 1 month after the primary series; significant increases were observed for mRNA-1273 and mRNA-1273.211 (P < 0.0001).","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Choi', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Chu', 'Affiliation': 'Benchmark Research, Austin, TX, USA.'}, {'ForeName': 'LingZhi', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Nunna', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Wenmei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Oestreicher', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Colpitts', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Bennett', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Legault', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Yamuna', 'Initials': 'Y', 'LastName': 'Paila', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Biliana', 'Initials': 'B', 'LastName': 'Nestorova', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Baoyu', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montefiori', 'Affiliation': 'Immune Assay Team at Duke University Medical Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Pajon', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Leav', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carfi', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'McPhee', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA.'}, {'ForeName': 'Darin K', 'Initials': 'DK', 'LastName': 'Edwards', 'Affiliation': 'Moderna Inc., Cambridge, MA, USA. darin.edwards@modernatx.com.'}]",Nature medicine,['10.1038/s41591-021-01527-y']
1566,34530112,Consumption of 85% cocoa dark chocolate improves mood in association with gut microbial changes in healthy adults: a randomized controlled trial.,"Dark chocolate has long been recognized for its mood-altering properties; however, the evidence regarding the emotional effects of daily dark chocolate intake is limited. Therefore, we aimed to investigate the effects of dark chocolate intake on mood in everyday life, with special emphasis on the gut-brain axis. Two different dark chocolates (85% and 70% cocoa content) were tested in this study. In a randomized controlled trial, healthy adults (20-30 y) consumed either 30 g/d of 85% cocoa chocolate (DC85, n=18); 70% cocoa chocolate (DC70, n=16); or no chocolate (control group, CON; n=14); for 3 weeks. Mood states were measured using the Positive and Negative Affect Schedule (PANAS). Daily consumption of dark chocolate significantly reduced negative affect in DC85, but not in DC70. To assess the association between the mood-altering effects of dark chocolate and the gut microbiota, we performed fecal 16S rRNA sequencing analysis for the DC85 and CON groups. Gut microbial diversity was significantly higher in DC85 than CON (P<.05). Blautia obeum levels were significantly elevated and Faecalibacterium prausnitzii levels were reduced in DC85 compared to CON (P<.05). Furthermore, we found that the observed changes in negative affect scores were negatively correlated with diversity and relative abundance of Blautia obeum (P<.05). These findings indicate that dark chocolate exerts prebiotic effects, as evidenced by its ability to restructure the diversity and abundance of intestinal bacteria; thus, it may improve negative emotional states via the gut-brain axis.",2021,Blautia obeum levels were significantly elevated and Faecalibacterium prausnitzii levels were reduced in DC85 compared to CON (p < 0.05).,"['healthy adults', 'healthy adults (20-30 y']","['dark chocolate intake', 'consumed either 30 g/d of 85% cocoa chocolate (DC85, n\u202f=\u202f18); 70% cocoa chocolate (DC70, n\u202f=\u202f16); or no chocolate (control group, CON', 'Consumption of 85% cocoa dark chocolate']","['Gut microbial diversity', 'diversity and relative abundance of Blautia obeum', 'Faecalibacterium prausnitzii levels', 'Mood states']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C3853217', 'cui_str': 'Dark chocolate'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0318080', 'cui_str': 'Ruminococcus obeum'}, {'cui': 'C0317558', 'cui_str': 'Faecalibacterium prausnitzii'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.169721,Blautia obeum levels were significantly elevated and Faecalibacterium prausnitzii levels were reduced in DC85 compared to CON (p < 0.05).,"[{'ForeName': 'Ji-Hee', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea; Research Group of Healthcare, Korea Food Research Institute, Jeollabuk-do, Republic of Korea.'}, {'ForeName': 'Chong-Su', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Cha', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Sojeong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Seokoh', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Suyeon', 'Initials': 'S', 'LastName': 'Chae', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Woo Young', 'Initials': 'WY', 'LastName': 'Chun', 'Affiliation': 'Department of Psychology, Chungnam National University, Daejeon, Republic of Korea. Electronic address: wooyoung@cnu.ac.kr.'}, {'ForeName': 'Dong-Mi', 'Initials': 'DM', 'LastName': 'Shin', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea; Research Institution of Human Ecology, Seoul National University, Seoul, Republic of Korea. Electronic address: shindm@snu.ac.kr.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2021.108854']
1567,34529735,A low-threshold intervention to increase physical activity and reduce physical inactivity in a group of healthy elderly people in Germany: Results of the randomized controlled MOVING study.,"BACKGROUND


Lack of physical activity (PA) and a high level of physical inactivity (PI) are associated with a higher risk for mortality and responsible for several non-communicable diseases including cardiovascular disease. Higher age is associated with a decrease of PA and an increasing level of PI. Studies have shown that interventions in the elderly have the potential to increase the amount of PA and to decrease the level of PI. However, most interventions are complex, elaborated, time- and resource-consuming. Here, we examined the effect of individual feedback-letters reporting the measured PA and PI in a sample of elderly people in Germany. Primary outcomes of the study were overall PA and PI after 6 months in the intervention group compared to a control group.
METHODS


We examined data from the MOVING intervention study (RCT) for people aged ≥ 65 years living in the northeast of Germany. At baseline, 3 and 6-months follow-up, all study participants wore a 3-axis accelerometer over a period of seven consecutive days. After the baseline measurement, the participants were randomized into intervention and control group. Participants in the intervention group received automatically generated, individualized feedback letters reporting their PA and PI by mail after the baseline measurement and after the 3-months follow-up. A Two-Way Mixed ANOVA with repeated measures was calculated with light, moderate and overall PA as well as PI as dependent variables, and group (between subject) and time (inner subject) as factors. The analysis based on retrospective data from the MOVING study (2016-2018).
RESULTS


N = 258 patients were recruited. N = 166 participants could be included in the analysis, thereof N = 97 women (58.4%). The mean age was 70.8 years (SD 4.8). At baseline, the participants had a mean wearing time of 5,934.5 minutes (SD = 789.5) per week, which corresponds to about 14 hours daily on average. The overall PA in the intervention group at the 6-months follow up was 2488.8 (95% CI 2358.9-2618.2) minutes and 2408.2 (95% CI 2263.0-2553.4) minutes in the control group. There was no statistically significant interaction effect (time*group) between the intervention and control group for the depending variables. Sensitivity analyses showed significant small positive effects of the interaction time*partnership, F(2, 300) = 3.020, p = 0.05, partial η2 = 0.020.
DISCUSSION


On average, study participants had high levels of PA at baseline and showed a good adherence in wearing the accelerometer. Both is likely due to selection in the convenience study sample. Thus, some ceiling effect reduced the overall intervention effect somewhat. At baseline, the weekly average of PI was 3436.7 minutes, which correspondents to about 8.2 hours per day and about 57% of participants' daily waking time. The average level of PI could be slightly decreased in both study groups.
TRIAL REGISTRATION NUMBER


DRKS00010410, 17 May 2017.",2021,There was no statistically significant interaction effect (time*group) between the intervention and control group for the depending variables.,"['elderly people in Germany', 'N = 258 patients were recruited', 'N = 166 participants could be included in the analysis, thereof N = 97 women (58.4', 'people aged ≥ 65 years living in the northeast of Germany', 'healthy elderly people in Germany']",['individual feedback-letters reporting the measured PA and PI'],"['overall PA and PI', 'physical activity and reduce physical inactivity', 'overall PA', 'average level of PI', 'level of PI', 'mean wearing time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",258.0,0.0747418,There was no statistically significant interaction effect (time*group) between the intervention and control group for the depending variables.,"[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Kleinke', 'Affiliation': 'Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Ulbricht', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Greifswald, Greifswald, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Dörr', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Greifswald, Greifswald, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Penndorf', 'Affiliation': 'Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hoffmann', 'Affiliation': 'Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Neeltje', 'Initials': 'N', 'LastName': 'van den Berg', 'Affiliation': 'Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany.'}]",PloS one,['10.1371/journal.pone.0257326']
1568,34530316,"VOICES: An efficacious trauma-informed, gender-responsive cannabis use intervention for justice and school-referred girls with lifetime substance use history.","BACKGROUND


Girls have unique developmental pathways to substance use and justice system involvement, warranting gender-responsive intervention. We tested the efficacy of VOICES (a 12-session, weekly trauma-informed, gender-responsive substance use intervention) in reducing substance use and HIV/STI risk behaviors among justice- and school-referred girls.
METHODS


Participants were 113 girls (M age  = 15.7 years, SD = 1.4; 12 % White, 19 % Black, 15 % multi-racial; 42 % Latinx) with a history of substance use referred from juvenile justice (29 %) and school systems (71 %). Study assessments were completed at baseline, 3-, 6- and 9-months follow-up. Primary outcomes included substance use and HIV/STI risk behaviors; secondary outcomes included psychiatric symptoms (including posttraumatic stress) and delinquent acts. We hypothesized that girls randomized to the VOICES (n = 51) versus GirlHealth (attention control; n = 62) condition would report reduced alcohol, cannabis and other substance use, HIV/STI risk behaviors, psychiatric symptoms, and delinquent acts.
RESULTS


Girls randomized to VOICES reported significantly less cannabis use over 9-month follow-up relative to the control condition (time by intervention, p < .01), but there were no between group differences over time in HIV/STI risk behavior. Girls in both conditions reported fewer psychiatric symptoms and delinquent acts over time.
CONCLUSIONS


Data support the use of a trauma-informed, gender-responsive intervention to reduce cannabis use among girls with a substance use history and legal involvement; reducing cannabis use in this population has implications for preventing future justice involvement and improving public health outcomes for girls and young women, who are at disproportionate health and legal risk relative to their male counterparts.",2021,"RESULTS


Girls randomized to VOICES reported significantly less cannabis use over 9-month follow-up relative to the control condition (time by intervention, p < .01), but there were no between group differences over time in HIV/STI risk behavior.","['justice and school-referred girls with lifetime substance use history', 'justice- and school-referred girls', 'Participants were 113 girls (M age  = 15.7 years, SD = 1.4; 12 % White, 19 % Black, 15 % multi-racial; 42 % Latinx) with a history of substance use referred from juvenile justice (29 %) and school systems (71 ', 'girls and young women, who are at disproportionate health and legal risk relative to their male counterparts']",['VOICES'],"['time in HIV/STI risk behavior', 'substance use and HIV/STI risk behaviors', 'psychiatric symptoms and delinquent acts over time', 'substance use and HIV/STI risk behaviors; secondary outcomes included psychiatric symptoms (including posttraumatic stress) and delinquent acts']","[{'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C1311631', 'cui_str': 'AM 113'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205350', 'cui_str': 'Disproportionate'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0522175', 'cui_str': 'Delinquent'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",113.0,0.0563177,"RESULTS


Girls randomized to VOICES reported significantly less cannabis use over 9-month follow-up relative to the control condition (time by intervention, p < .01), but there were no between group differences over time in HIV/STI risk behavior.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Tolou-Shams', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry and Behavioral Sciences, 1001 Potrero Ave, San Francisco, CA, 94110, United States. Electronic address: marina.tolou-shams@ucsf.edu.'}, {'ForeName': 'Emily F', 'Initials': 'EF', 'LastName': 'Dauria', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry and Behavioral Sciences, 1001 Potrero Ave, San Francisco, CA, 94110, United States. Electronic address: emily.dauria@ucsf.edu.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Folk', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry and Behavioral Sciences, 1001 Potrero Ave, San Francisco, CA, 94110, United States. Electronic address: johanna.folk@ucsf.edu.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Shumway', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry and Behavioral Sciences, 1001 Potrero Ave, San Francisco, CA, 94110, United States. Electronic address: martha.shumway@ucsf.edu.'}, {'ForeName': 'Brandon D L', 'Initials': 'BDL', 'LastName': 'Marshall', 'Affiliation': 'Brown University School of Public Health, Department of Epidemiology, 121 South Main Street, Providence, RI, 02912, United States. Electronic address: Brandon_Marshall@brown.edu.'}, {'ForeName': 'Christie J', 'Initials': 'CJ', 'LastName': 'Rizzo', 'Affiliation': 'Department of Applied Psychology, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA, 02115, United States. Electronic address: c.rizzo@northeastern.edu.'}, {'ForeName': 'Nena', 'Initials': 'N', 'LastName': 'Messina', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, 11075 Santa Monica Blvd., Suite 200, Los Angeles, CA, 90025, United States. Electronic address: nmessina@g.ucla.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Covington', 'Affiliation': 'Center for Gender and Justice, La Jolla, CA, United States. Electronic address: sc@stephaniecovington.com.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Haack', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry and Behavioral Sciences, 1001 Potrero Ave, San Francisco, CA, 94110, United States.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Chaffee', 'Affiliation': 'University of California, San Francisco, Department of Pediatrics, 1001 Potrero Ave, San Francisco, CA, 94110, United States. Electronic address: tonya.chaffee@ucsf.edu.'}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, 222 Richmond St, Providence, RI, 02903, United States. Electronic address: LKBrown@lifespan.org.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108934']
1569,34530310,Effects of assistive devices on postural control following a balance disturbance along the anterior-posterior direction.,"BACKGROUND


Assistive devices provide balance and stability to those who require a greater base of support, especially during ambulation or in tasks essential to functional daily living. In ambulatory assistive device use, center of pressure (COP) movement as one of the measurements of postural control is a factor when assessing fall risk, with an overall goal of maintaining postural equilibrium. There is a lack of research on assistive devices, such as walkers, regarding measurable outcome variables related to fall risk. The purpose of this study was to determine how much the postural control in single limb stance during a balance perturbance is affected by utilizing three different walker types designed to promote stability: the standard walker, the front-wheeled walker with straight wheels and the front-wheeled walker with caster wheels.
RESEARCH QUESTION


Is postural sway control in single limb stance during a balance perturbance affected by walker type?
METHODS


Twenty-three healthy adults participated and gave consent. The NeuroCom® SMART EquiTest® system was utilized to simulate forward falls. Subjects stood on the system's force plate, which was tipped backwards quickly, forcing subjects to attempt to maintain balance. Each participant experienced 18 simulated perturbations, during which they were asked to maintain balance while using one of three walkers in single-limb stance. Each trial was completed using random assignment of three different walker types. Leg dominance of the stance leg was also randomized for each trial.
RESULTS


The type of walker and the leg dominance in the standing limb significantly affected postural control in a balance perturbance in the A-P direction. The walker type significantly affected the COP maximum displacement in anterior-posterior (AP) direction. However, the leg dominance significantly affected COP maximum displacement in AP and medio-lateral (ML) directions and COP velocity in AP direction.
SIGNIFICANCE


The findings suggest that when fully grounded, a standard walker is more stable than the front-wheeled walker. However, this does not indicate that the standard walker is more stable than other types of walkers when it is being picked up and moved forward during normal use.",2021,"However, the leg dominance significantly affected COP maximum displacement in AP and medio-lateral (ML) directions and COP velocity in AP direction.
",['Twenty-three healthy adults participated and gave consent'],['assistive devices'],"['COP maximum displacement', 'Leg dominance', 'COP maximum displacement in AP and medio-lateral (ML) directions and COP velocity']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0036605', 'cui_str': 'Assistive equipment'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",23.0,0.0184971,"However, the leg dominance significantly affected COP maximum displacement in AP and medio-lateral (ML) directions and COP velocity in AP direction.
","[{'ForeName': 'Yunju', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Grand Valley State University, Grand Rapids, MI, USA; School of Engineering, Grand Valley State University, Grand Rapids, MI, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Badr', 'Affiliation': 'Department of Physical Therapy, Grand Valley State University, Grand Rapids, MI, USA.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Bove', 'Affiliation': 'Department of Physical Therapy, Grand Valley State University, Grand Rapids, MI, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jewett', 'Affiliation': 'Department of Physical Therapy, Grand Valley State University, Grand Rapids, MI, USA.'}, {'ForeName': 'Meri', 'Initials': 'M', 'LastName': 'Goehring', 'Affiliation': 'Department of Physical Therapy, Grand Valley State University, Grand Rapids, MI, USA. Electronic address: goehrinm@gvsu.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2021.09.169']
1570,34530287,The memory benefits of two naps per day during infancy: A pilot investigation.,"In infancy, sleep occurs in multiple nap and overnight bouts that change developmentally in quantity and distribution. Though studies suggest that infant memory benefits from a single nap, no work has assessed the relative benefits of different naps (morning vs. afternoon), nor how multiple naps support memory across the day. We investigated the memory benefit of a morning nap, relative to morning wake, and the effect of these intervals on afternoon nap function in 9-month-olds (n = 15). Infants participated in two within-subjects conditions (separated by 1-2 weeks). In the Nap-Nap condition, infants took their morning and afternoon naps; in the Wake-Nap condition, infants were kept awake during morning naptime, but napped unrestricted in the afternoon. Before each nap/wake interval, infants completed an imitation memory task, with memory assessed again shortly after the nap/wake interval. In the Nap-Nap condition, infants showed memory retention across morning and afternoon naps. In contrast, infants tended to forget items learned across morning wake in the Wake-Nap condition. Moreover, morning wake was associated with a significant decline in post-nap retention of items learned in the afternoon. Furthermore, relations between nap slow-wave activity (SWA) and memory varied across naps, with SWA either not predicting (morning naps) or positively predicting (afternoon naps) memory change in the Nap-Nap condition, but negatively predicting afternoon memory change in the Wake-Nap condition. We conclude that two naps per day (rather than one) aids memory at 9 months, and that skipping the morning nap may moderate relations between afternoon nap physiology and memory.",2021,"Furthermore, relations between nap slow-wave activity (SWA) and memory varied across naps, with SWA either not predicting (morning naps) or positively predicting (afternoon naps) memory change in the Nap-Nap condition, but negatively predicting afternoon memory change in the Wake-Nap condition.",['9-month-olds (n = 15'],[],"['afternoon nap function', 'memory retention across morning and afternoon naps', 'Furthermore, relations between nap slow-wave activity (SWA) and memory varied across naps, with SWA either not predicting (morning naps) or positively predicting (afternoon naps) memory change']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",15.0,0.0320865,"Furthermore, relations between nap slow-wave activity (SWA) and memory varied across naps, with SWA either not predicting (morning naps) or positively predicting (afternoon naps) memory change in the Nap-Nap condition, but negatively predicting afternoon memory change in the Wake-Nap condition.","[{'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Mason', 'Affiliation': 'Department of Psychological & Brain Sciences, United States; Neuroscience & Behavior Program, University of Massachusetts, Amherst, United States.'}, {'ForeName': 'Laura B F', 'Initials': 'LBF', 'LastName': 'Kurdziel', 'Affiliation': 'Department of Psychology, Merrimack College, United States.'}, {'ForeName': 'Rebecca M C', 'Initials': 'RMC', 'LastName': 'Spencer', 'Affiliation': 'Department of Psychological & Brain Sciences, United States; Neuroscience & Behavior Program, University of Massachusetts, Amherst, United States; Institute for Applied Life Sciences, University of Massachusetts, Amherst, United States. Electronic address: rspencer@umass.edu.'}]",Infant behavior & development,['10.1016/j.infbeh.2021.101647']
1571,34534863,Optimizing opioid use disorder treatment with naltrexone or buprenorphine.,"BACKGROUND


Relapse rates during opioid use disorder (OUD) treatment remain unacceptably high. It is possible that optimally matching patients with medication type would reduce risk of relapse. Our objective was to learn a rule by which to assign type of medication for OUD to reduce risk of relapse, and to estimate the extent to which risk of relapse would be reduced if such a rule were used.
METHODS


This was a secondary analysis of an open-label randomized controlled, 24-week comparative effectiveness trial of injection extended-release naltrexone (XR-NTX), delivered approximately every 28 days, or daily sublingual buprenorphine-naloxone (BUP-NX) for treating OUD, 2014-2017 (N = 570). Outcome was a binary indicator of relapse to regular opioid use during the 24 weeks of outpatient treatment.
RESULTS


We found that applying an estimated individualized treatment rule-i.e., a rule that assigns patients with OUD to either XR-NTX or BUP-NX based on their individual characteristics in such a way that risk of relapse is minimized-would reduce risk of relapse by 24 weeks by 12% compared to randomly assigned treatment.
CONCLUSIONS


The number-needed-to-treat with the estimated treatment rule to prevent a single relapse is 14. A simpler, alternative estimated rule in which homeless participants would be treated with XR-NTX and stably housed participants would be treated with BUP-NX performed similarly. These results provide an estimate of the amount by which a relatively simple change in clinical practice could be expected to improve prevention of OUD relapse.",2021,"We found that applying an estimated individualized treatment rule-i.e., a rule that assigns patients with OUD to either XR-NTX or BUP-NX based on their individual characteristics in such a way that risk of relapse is minimized-would reduce risk of relapse by 24 weeks by 12% compared to randomly assigned treatment.
",['homeless participants'],"['XR-NTX', 'injection extended-release naltrexone (XR-NTX', 'buprenorphine-naloxone (BUP-NX', 'naltrexone or buprenorphine']",['risk of relapse'],"[{'cui': 'C0237154', 'cui_str': 'Homeless'}]","[{'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.137548,"We found that applying an estimated individualized treatment rule-i.e., a rule that assigns patients with OUD to either XR-NTX or BUP-NX based on their individual characteristics in such a way that risk of relapse is minimized-would reduce risk of relapse by 24 weeks by 12% compared to randomly assigned treatment.
","[{'ForeName': 'Kara E', 'Initials': 'KE', 'LastName': 'Rudolph', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, United States. Electronic address: kr2854@cumc.columbia.edu.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Díaz', 'Affiliation': 'Division of Biostatistics, Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, United States.'}, {'ForeName': 'Sean X', 'Initials': 'SX', 'LastName': 'Luo', 'Affiliation': 'Department of Psychiatry, School of Medicine, Columbia University, and New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Department of Psychiatry, School of Medicine, New York University, New York, NY, United States.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry, School of Medicine, Columbia University, and New York State Psychiatric Institute, New York, NY, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109031']
1572,34534800,A pilot study of intensive 7-day internet-based cognitive behavioral therapy for social anxiety disorder.,"Accessible, affordable cognitive behavioral therapy (CBT) options for Social Anxiety Disorder (SAD) that allow for rapid symptom improvement are needed. The present study investigated the first intensive, 7-day internet-based CBT for SAD. An open pilot trial was conducted to test the acceptability, feasibility and preliminary outcomes of the program in a sample of 16 participants (9 females, M age = 40.34, SD = 10.55) with a DSM-5 diagnosis of SAD. Participants were enrolled into the 6-lesson online program, and completed the Social Phobia Scale [SPS], Social Interaction Anxiety Scale [SIAS], Patient Health Questionnaire-9 (PHQ-9), and Work and Social Adjustment Scale (WSAS) at baseline, post and one month follow-up. We found support for the feasibility and acceptability of the program; 15 participants (93.8%) completed the program, and all participants reported the program was satisfactory. Large, significant reductions in social anxiety severity on both the SPS and SIAS (Hedges' g s  = 1.26-1.9) and functional impairment (WSAS; g s  = 0.88-0.98) were found at post-treatment and follow-up. Medium, significant reductions in depressive symptom severity were also found (g s  = 0.88-0.98 at post and follow-up, respectively). A third of participants scored below the clinical cut-off on both the SPS and SIAS at post-treatment and follow-up. A randomized controlled trial with longer follow-up is needed to evaluate the efficacy of this intensive internet-based treatment for SAD. Implications and future research directions are discussed.",2021,"We found support for the feasibility and acceptability of the program; 15 participants (93.8%) completed the program, and all participants reported the program was satisfactory.","['social anxiety disorder', '16 participants (9 females, M age\xa0=\xa040.34, SD\xa0=\xa010.55) with a DSM-5 diagnosis of SAD']","['intensive 7-day internet-based cognitive behavioral therapy', 'cognitive behavioral therapy (CBT']","['Social Phobia Scale [SPS], Social Interaction Anxiety Scale [SIAS], Patient Health Questionnaire-9', 'depressive symptom severity', 'social anxiety severity', 'PHQ-9), and Work and Social Adjustment Scale (WSAS', 'functional impairment', 'feasibility and acceptability']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",16.0,0.0262912,"We found support for the feasibility and acceptability of the program; 15 participants (93.8%) completed the program, and all participants reported the program was satisfactory.","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': ""School of Psychology, University of New South Wales Sydney, New South Wales 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Stech', 'Affiliation': ""School of Psychology, University of New South Wales Sydney, New South Wales 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia.""}, {'ForeName': 'Ashlee B', 'Initials': 'AB', 'LastName': 'Grierson', 'Affiliation': ""School of Psychiatry, University of New South Wales Sydney, New South Wales 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia.""}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Sharrock', 'Affiliation': ""School of Psychiatry, University of New South Wales Sydney, New South Wales 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Li', 'Affiliation': ""School of Psychiatry, University of New South Wales Sydney, New South Wales 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia.""}, {'ForeName': 'Alison E J', 'Initials': 'AEJ', 'LastName': 'Mahoney', 'Affiliation': ""School of Psychiatry, University of New South Wales Sydney, New South Wales 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia.""}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Newby', 'Affiliation': 'School of Psychology, University of New South Wales Sydney, New South Wales 2052, Australia; Black Dog Institute, Randwick, New South Wales 2031, Australia. Electronic address: j.newby@unsw.edu.au.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2021.102473']
1573,34534493,Rationale and Design of the Groningen Intervention Study for the Preservation of Cardiac Function with Sodium Thiosulfate after St-segment Elevation Myocardial Infarction (GIPS-IV) trial.,"BACKGROUND


Ischemia and subsequent reperfusion cause myocardial injury in patients presenting with ST-segment elevation myocardial infarction (STEMI). Hydrogen sulfide (H 2 S) reduces ""ischemia-reperfusion injury"" in various experimental animal models, but has not been evaluated in humans. This trial will examine the efficacy and safety of the H 2 S-donor sodium thiosulfate (STS) in patients presenting with a STEMI.
STUDY DESIGN


The Groningen Intervention study for the Preservation of cardiac function with STS after STEMI (GIPS-IV) trial (NCT02899364) is a double-blind, randomized, placebo-controlled, multicenter trial, which will enroll 380 patients with a first STEMI. Patients receive STS 12.5 grams intravenously or matching placebo in addition to standard care immediately at arrival at the catheterization laboratory after providing consent. A second dose is administered 6 hours later at the coronary care unit. The primary endpoint is myocardial infarct size as quantified by cardiac magnetic resonance imaging 4 months after randomization. Secondary endpoints include the effect of STS on peak CK-MB during admission and left ventricular ejection fraction and NT-proBNP levels at 4 months follow-up. Patients will be followed-up for 2 years to assess clinical endpoints.
CONCLUSIONS


The GIPS-IV trial is the first study to determine the effect of a H 2 S-donor on myocardial infarct size in patients presenting with STEMI.",2021,"Hydrogen sulfide (H 2 S) reduces ""ischemia-reperfusion injury"" in various experimental animal models, but has not been evaluated in humans.","['patients presenting with STEMI', 'patients presenting with a STEMI', 'patients presenting with ST-segment elevation myocardial infarction (STEMI', '380 patients with a first STEMI']","['Hydrogen sulfide (H 2 S', 'STS 12.5 gram intravenously or matching placebo', 'placebo', 'H 2 S-donor sodium thiosulfate (STS']","['effect of STS on peak CK-MB during admission and left ventricular ejection fraction and NT-proBNP levels', 'efficacy and safety', 'myocardial infarct size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C4319693', 'cui_str': '380'}]","[{'cui': 'C0020282', 'cui_str': 'Hydrogen sulfide'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0074774', 'cui_str': 'sodium thiosulfate'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0074774', 'cui_str': 'sodium thiosulfate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0585045', 'cui_str': 'During admission'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",380.0,0.238698,"Hydrogen sulfide (H 2 S) reduces ""ischemia-reperfusion injury"" in various experimental animal models, but has not been evaluated in humans.","[{'ForeName': 'Marie-Sophie Ly', 'Initials': 'ML', 'LastName': 'de Koning', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. Electronic address: m.s.l.y.de.koning@umcg.nl.'}, {'ForeName': 'Paulien', 'Initials': 'P', 'LastName': 'van Dorp', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Assa', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Minke Ht', 'Initials': 'MH', 'LastName': 'Hartman', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, Division of Heart & Lungs, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Rutger L', 'Initials': 'RL', 'LastName': 'Anthonio', 'Affiliation': 'Department of Cardiology, Treant hospital location Scheper, Emmen, the Netherlands.'}, {'ForeName': 'Duco', 'Initials': 'D', 'LastName': 'Veen', 'Affiliation': 'Department of Methodology and Statistics, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Gabija', 'Initials': 'G', 'LastName': 'Pundziute-Do Prado', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Leiner', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'van Goor', 'Affiliation': 'Department of Pathology and Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Meer', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lipsic', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Department of Cardiology, Division of Heart & Lungs, University Medical Center Utrecht, Utrecht, the Netherlands.'}]",American heart journal,['10.1016/j.ahj.2021.08.012']
1574,34534429,"Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer.","BACKGROUND


Pembrolizumab has efficacy in programmed death ligand 1 (PD-L1)-positive metastatic or unresectable cervical cancer that has progressed during chemotherapy. We assessed the relative benefit of adding pembrolizumab to chemotherapy with or without bevacizumab.
METHODS


In a double-blind, phase 3 trial, we randomly assigned patients with persistent, recurrent, or metastatic cervical cancer in a 1:1 ratio to receive pembrolizumab (200 mg) or placebo every 3 weeks for up to 35 cycles plus platinum-based chemotherapy and, per investigator discretion, bevacizumab. The dual primary end points were progression-free survival and overall survival, each tested sequentially in patients with a PD-L1 combined positive score of 1 or more, in the intention-to-treat population, and in patients with a PD-L1 combined positive score of 10 or more. The combined positive score is defined as the number of PD-L1-staining cells divided by the total number of viable tumor cells, multiplied by 100. All results are from the protocol-specified first interim analysis.
RESULTS


In 548 patients with a PD-L1 combined positive score of 1 or more, median progression-free survival was 10.4 months in the pembrolizumab group and 8.2 months in the placebo group (hazard ratio for disease progression or death, 0.62; 95% confidence interval [CI], 0.50 to 0.77; P<0.001). In 617 patients in the intention-to-treat population, progression-free survival was 10.4 months and 8.2 months, respectively (hazard ratio, 0.65; 95% CI, 0.53 to 0.79; P<0.001). In 317 patients with a PD-L1 combined positive score of 10 or more, progression-free survival was 10.4 months and 8.1 months, respectively (hazard ratio, 0.58; 95% CI, 0.44 to 0.77; P<0.001). Overall survival at 24 months was 53.0% in the pembrolizumab group and 41.7% in the placebo group (hazard ratio for death, 0.64; 95% CI, 0.50 to 0.81; P<0.001), 50.4% and 40.4% (hazard ratio, 0.67; 95% CI, 0.54 to 0.84; P<0.001), and 54.4% and 44.6% (hazard ratio, 0.61; 95% CI, 0.44 to 0.84; P = 0.001), respectively. The most common grade 3 to 5 adverse events were anemia (30.3% in the pembrolizumab group and 26.9% in the placebo group) and neutropenia (12.4% and 9.7%, respectively).
CONCLUSIONS


Progression-free and overall survival were significantly longer with pembrolizumab than with placebo among patients with persistent, recurrent, or metastatic cervical cancer who were also receiving chemotherapy with or without bevacizumab. (Funded by Merck Sharp and Dohme; KEYNOTE-826 ClinicalTrials.gov number, NCT03635567.).",2021,"Overall survival at 24 months was 53.0% in the pembrolizumab group and 41.7% in the placebo group (hazard ratio for death, 0.64; 95% CI, 0.50 to 0.81; P<0.001), 50.4% and 40.4% (hazard ratio, 0.67; 95% CI, 0.54 to 0.84; P<0.001), and 54.4% and 44.6% (hazard ratio, 0.61; 95% CI, 0.44 to 0.84; P = 0.001), respectively.","['patients with persistent, recurrent, or metastatic cervical cancer in a 1:1 ratio to receive', 'patients with persistent, recurrent, or metastatic cervical cancer who were also receiving chemotherapy with or without']","['bevacizumab', 'pembrolizumab', 'pembrolizumab to chemotherapy with or without bevacizumab', 'platinum-based chemotherapy and, per investigator discretion, bevacizumab', 'Pembrolizumab', 'placebo']","['progression-free survival and overall survival', 'median progression-free survival', 'Overall survival', 'neutropenia', 'progression-free survival', 'anemia', 'Progression-free and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0278584', 'cui_str': 'Cervix cancer metastatic'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",548.0,0.959872,"Overall survival at 24 months was 53.0% in the pembrolizumab group and 41.7% in the placebo group (hazard ratio for death, 0.64; 95% CI, 0.50 to 0.81; P<0.001), 50.4% and 40.4% (hazard ratio, 0.67; 95% CI, 0.54 to 0.84; P<0.001), and 54.4% and 44.6% (hazard ratio, 0.61; 95% CI, 0.44 to 0.84; P = 0.001), respectively.","[{'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Coraline', 'Initials': 'C', 'LastName': 'Dubot', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'M Valeria', 'Initials': 'MV', 'LastName': 'Caceres', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Kosei', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Shapira-Frommer', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Salman', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Hoyos Usta', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Yañez', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Mivael', 'Initials': 'M', 'LastName': 'Olivera Hurtado de Mendoza', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Samouëlian', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Castonguay', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Arkhipov', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Sarper', 'Initials': 'S', 'LastName': 'Toker', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Keefe', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': ""From the University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) - both in Italy; Institut Curie Saint-Cloud, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel (R.S.-F.); the University of California, Irvine, Orange (K.S.T.); Oncovida Cancer Center, Providencia (P.S.), and Universidad de la Frontera, Temuco (E.Y.) - both in Chile; IMAT (Instituto Médico de Alta Tecnología) Oncomedica, Monteria, Colombia (E.H.U.); Istanbul Medeniyet University Hospital, Istanbul, Turkey (M.G.); Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (M.O.H.M.); Centre Hospitalier de l'Université de Montréal, Centre de Recherche de l'Université de Montréal, Université de Montréal, Montreal (V.S.), and Centre Hospitalier Universitaire de Québec, Université Laval, Quebec (V.C.) - both in Quebec, Canada; the Medical Rehabilitation Center of the Ministry of Health of the Russian Federation, Moscow (A.A.); Merck, Kenilworth, NJ (S.T., K.L., S.M.K.); and Arizona Oncology (U.S. Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2112435']
1575,34537477,A mindfulness meditation mobile app improves depression and anxiety in adults with sleep disturbance: Analysis from a randomized controlled trial.,"OBJECTIVE


The objective of this study was to 1) determine the effects of a meditation app on depression and anxiety in adults with sleep disturbance, and 2) explore the potential mediating effects of fatigue, daytime sleepiness, and pre-sleep arousal on the relationship between use of the meditation app and changes in depression and anxiety.
METHODS


Participants were 239 adults with elevated insomnia symptoms (i.e., scores ≥ 10 on the Insomnia Severity Index) and limited or no previous experience with meditation. Depression, anxiety, fatigue, daytime sleepiness, and pre-sleep arousal were assessed at baseline, four weeks, and eight weeks. Repeated-measures ANCOVAs assessed intervention effects on depression and anxiety. Mediation models were estimated using the PROCESS macro.
RESULTS


Participants in the meditation group had more improvement in depression and anxiety symptoms during the intervention period than did those in the control group. Changes in somatic and cognitive pre-sleep arousal at mid-intervention fully mediated effects on depression and partially mediated effects on anxiety. There were no significant indirect effects of fatigue and daytime-sleepiness on changes in mental health.
CONCLUSIONS


A meditation app may improve depression and anxiety in adults with sleep disturbance, with effects being driven by improvements in pre-sleep arousal. Future studies should consider targeting pre-sleep arousal to improve mental health in this population.",2021,"There were no significant indirect effects of fatigue and daytime-sleepiness on changes in mental health.
","['adults with sleep disturbance', 'Participants were 239 adults with elevated insomnia symptoms (i.e., scores\xa0≥\xa010 on the Insomnia Severity Index) and limited or no previous experience with meditation', 'adults with sleep disturbance, and 2']",['meditation app'],"['depression and anxiety', 'depression and anxiety symptoms', 'anxiety', 'fatigue and daytime-sleepiness', 'Depression, anxiety, fatigue, daytime sleepiness, and pre-sleep arousal', 'somatic and cognitive pre-sleep arousal']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}]",239.0,0.0855749,"There were no significant indirect effects of fatigue and daytime-sleepiness on changes in mental health.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Huberty', 'Affiliation': 'College of Health Solutions, Arizona State University, 500 N. 3rd St., Phoenix, AZ 85004, USA. Electronic address: jhuberty@asu.edu.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Puzia', 'Affiliation': 'Behavioral Research and Analytics, LLC, 154 S St., Salt Lake City, UT 84103, USA.'}, {'ForeName': 'Jeni', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'College of Health Solutions, Arizona State University, 500 N. 3rd St., Phoenix, AZ 85004, USA. Electronic address: Jeni.green@asu.edu.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Vlisides-Henry', 'Affiliation': 'Department of Psychology, University of Utah, 380 S. 1530 E., Salt Lake City, UT 84112, USA. Electronic address: robert.vlisideshenry@psych.utah.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Larkey', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 N. 3rd St., Phoenix, AZ 85004, USA. Electronic address: Linda.larkey@asu.edu.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Cousins Center for Psychoneuroimmunology and Mindful Awareness Research Center, Terry Semel Institute for Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, Los Angeles, CA 90095, USA; Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, 300 UCLA Medical Plaza #3109, Los Angeles, CA 90095, USA. Electronic address: Mirwin1@ucla.edu.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA 02114, USA. Electronic address: avranceanu@mgh.harvard.edu.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2021.09.004']
1576,34535524,"Successful Trial of Practice Facilitation for Plan, Do, Study, Act Quality Improvement.","BACKGROUND


Practice facilitation (PF) is a promising but relatively new intervention supporting data-driven practice change. There is a need to better detail research-based facilitation methods, which must balance intervention fidelity and time restrictions with the flexibility required for the intervention. As part of a multi-level 4-armed cluster randomized clinical trial (RCT), 32 rural primary care practices received PF for 1 year. We evaluated the feasibility of having facilitators guide practices to perform 4 key driver domain activities, implemented as Plan-Do-Study-Act (PDSA) cycles, to better understand facilitation ""exposure."" We describe the intervention and activity length such that our experiences may be useful to other PF research efforts.
METHODS


Thirty-two practices serving rural patients involved in the Southeastern Collaboration to Improvement Blood Pressure Control engaged with a facilitator to develop and implement PDSAs nested within key drivers of change domains. Numbers of months practices worked on activities deemed most likely to be sustained were captured along with practice satisfaction data.
RESULTS


All practices engaged in at least 4 domain-level activities, and 59% of the PDSAs were active for at least 3 months. There was variation by domain in the average length of the PDSA activities. Ninety-seven percent (31 of 32) of practices recommended similarly structured facilitation services to other primary care practices, and 84% (27 of 32) noted substantive changes in their care processes.
CONCLUSION


In this trial, it was feasible for PFs to engage practices in at least 4 Key Driver quality improvement activities within 1 year, which will inform PF methods and protocol development in future trials.",2021,"Ninety-seven percent (31 of 32) of practices recommended similarly structured facilitation services to other primary care practices, and 84% (27 of 32) noted substantive changes in their care processes.
","['32 rural primary care practices received PF for 1 year', 'Thirty-two practices serving rural patients involved in the Southeastern Collaboration to Improvement Blood Pressure Control engaged with a facilitator to develop and implement PDSAs nested within key drivers of change domains']",[],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",[],[],32.0,0.170411,"Ninety-seven percent (31 of 32) of practices recommended similarly structured facilitation services to other primary care practices, and 84% (27 of 32) noted substantive changes in their care processes.
","[{'ForeName': 'Kent F', 'Initials': 'KF', 'LastName': 'Sutton', 'Affiliation': 'From the University of North Carolina at Chapel Hill, Cecil G. Sheps Center for Health Services Research (KFS, ELR, JRH); Duke University School of Medicine, Durham, NC (KFS); University of North Carolina at Chapel Hill, North Carolina Translational and Clinical Sciences (JRR); University of Alabama at Birmingham, Birmingham, AL (LLP, MMC); Samford University, Birmingham, AL (LLP, SHP); East Carolina University, Greenville, NC (MM); Area L Area Health Education Center, Rocky Mount, NC (JRH).'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Richman', 'Affiliation': 'From the University of North Carolina at Chapel Hill, Cecil G. Sheps Center for Health Services Research (KFS, ELR, JRH); Duke University School of Medicine, Durham, NC (KFS); University of North Carolina at Chapel Hill, North Carolina Translational and Clinical Sciences (JRR); University of Alabama at Birmingham, Birmingham, AL (LLP, MMC); Samford University, Birmingham, AL (LLP, SHP); East Carolina University, Greenville, NC (MM); Area L Area Health Education Center, Rocky Mount, NC (JRH). elr@email.unc.edu.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Rees', 'Affiliation': 'From the University of North Carolina at Chapel Hill, Cecil G. Sheps Center for Health Services Research (KFS, ELR, JRH); Duke University School of Medicine, Durham, NC (KFS); University of North Carolina at Chapel Hill, North Carolina Translational and Clinical Sciences (JRR); University of Alabama at Birmingham, Birmingham, AL (LLP, MMC); Samford University, Birmingham, AL (LLP, SHP); East Carolina University, Greenville, NC (MM); Area L Area Health Education Center, Rocky Mount, NC (JRH).'}, {'ForeName': 'Liza L', 'Initials': 'LL', 'LastName': 'Pugh-Nicholson', 'Affiliation': 'From the University of North Carolina at Chapel Hill, Cecil G. Sheps Center for Health Services Research (KFS, ELR, JRH); Duke University School of Medicine, Durham, NC (KFS); University of North Carolina at Chapel Hill, North Carolina Translational and Clinical Sciences (JRR); University of Alabama at Birmingham, Birmingham, AL (LLP, MMC); Samford University, Birmingham, AL (LLP, SHP); East Carolina University, Greenville, NC (MM); Area L Area Health Education Center, Rocky Mount, NC (JRH).'}, {'ForeName': 'Macie M', 'Initials': 'MM', 'LastName': 'Craft', 'Affiliation': 'From the University of North Carolina at Chapel Hill, Cecil G. Sheps Center for Health Services Research (KFS, ELR, JRH); Duke University School of Medicine, Durham, NC (KFS); University of North Carolina at Chapel Hill, North Carolina Translational and Clinical Sciences (JRR); University of Alabama at Birmingham, Birmingham, AL (LLP, MMC); Samford University, Birmingham, AL (LLP, SHP); East Carolina University, Greenville, NC (MM); Area L Area Health Education Center, Rocky Mount, NC (JRH).'}, {'ForeName': 'Shannon H', 'Initials': 'SH', 'LastName': 'Peaden', 'Affiliation': 'From the University of North Carolina at Chapel Hill, Cecil G. Sheps Center for Health Services Research (KFS, ELR, JRH); Duke University School of Medicine, Durham, NC (KFS); University of North Carolina at Chapel Hill, North Carolina Translational and Clinical Sciences (JRR); University of Alabama at Birmingham, Birmingham, AL (LLP, MMC); Samford University, Birmingham, AL (LLP, SHP); East Carolina University, Greenville, NC (MM); Area L Area Health Education Center, Rocky Mount, NC (JRH).'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Mackey', 'Affiliation': 'From the University of North Carolina at Chapel Hill, Cecil G. Sheps Center for Health Services Research (KFS, ELR, JRH); Duke University School of Medicine, Durham, NC (KFS); University of North Carolina at Chapel Hill, North Carolina Translational and Clinical Sciences (JRR); University of Alabama at Birmingham, Birmingham, AL (LLP, MMC); Samford University, Birmingham, AL (LLP, SHP); East Carolina University, Greenville, NC (MM); Area L Area Health Education Center, Rocky Mount, NC (JRH).'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Halladay', 'Affiliation': 'From the University of North Carolina at Chapel Hill, Cecil G. Sheps Center for Health Services Research (KFS, ELR, JRH); Duke University School of Medicine, Durham, NC (KFS); University of North Carolina at Chapel Hill, North Carolina Translational and Clinical Sciences (JRR); University of Alabama at Birmingham, Birmingham, AL (LLP, MMC); Samford University, Birmingham, AL (LLP, SHP); East Carolina University, Greenville, NC (MM); Area L Area Health Education Center, Rocky Mount, NC (JRH).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2021.05.210140']
1577,34515160,Outcomes of Remote Patient Monitoring for Automated Peritoneal Dialysis: A Randomized Controlled Trial.,"INTRODUCTION


We hypothesize that remote patient monitoring (RPM) for automated peritoneal dialysis (APD) and feedback could enhance patient self-management and improve outcomes. The aim of this study was to evaluate the efficacy of RPM-APD compared to traditional APD (T-APD) without RPM.
METHODS


In this multicenter, randomized controlled trial, patients on APD were randomized to T-APD (n = 29) or RPM-APD (n = 28) at 12 weeks and followed until 25 weeks. Health-related quality of life (HRQOL), patient and medical staff satisfaction with RPM-APD, and dialysis-related outcomes were compared between the 2 groups.
RESULTS


We found no significant differences in HRQOL scores at the time of enrollment and randomization between RPM-APD and T-APD. At the end of the study, the RPM-APD group showed better HRQOL for the sleep domain (p = 0.049) than the T-APD group and the T-APD group showed better HRQOL for the sexual function domain (p = 0.030) than the RPM-APD group. However, we found no significant interactions between the time and groups in terms of HRQOL. Different HRQOL domains significantly improved over time in patients undergoing RPM-APD (effects of kidney disease, p = 0.025) and T-APD (burden of kidney disease, p = 0.029; physical component summary, p = 0.048). Though medical staff satisfaction with RPM-APD was neutral, most patients were quite satisfied with RPM-APD (median score 82; possible total score 105 on 21 5-item scales) and the rating scores were maintained during the study period. We found no significant differences in dialysis adherence, accuracy, adequacy, overhydration status, blood pressure, or the number of unplanned visits between the 2 groups.
DISCUSSION/CONCLUSION


Although HRQOL and dialysis-related outcomes were comparable between RPM-APD and T-APD, RPM-APD was positive in terms of patient satisfaction. Further long-term and large-scale studies will be required to determine the efficacy of RPM-APD.
TRIAL REGISTRATION


CRIS identifier: KCT0003390, registered on December 14, 2018 - retrospectively registered, https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=12348.",2021,"Different HRQOL domains significantly improved over time in patients undergoing RPM-APD (effects of kidney disease, p = 0.025) and T-APD (burden of kidney disease, p = 0.029; physical component summary, p = 0.048).","['patients on APD', 'CRIS identifier', 'registered on December 14, 2018 - retrospectively registered, https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=12348']","['Remote Patient Monitoring for Automated Peritoneal Dialysis', 'T-APD', 'RPM-APD', 'traditional APD (T-APD']","['Health-related quality of life (HRQOL), patient and medical staff satisfaction with RPM-APD, and dialysis-related outcomes', 'dialysis adherence, accuracy, adequacy, overhydration status, blood pressure, or the number of unplanned visits', 'HRQOL scores', 'HRQOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997821', 'cui_str': 'Automated peritoneal dialysis'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1997821', 'cui_str': 'Automated peritoneal dialysis'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1997821', 'cui_str': 'Automated peritoneal dialysis'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0392689', 'cui_str': 'Overhydration'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0955256,"Different HRQOL domains significantly improved over time in patients undergoing RPM-APD (effects of kidney disease, p = 0.025) and T-APD (burden of kidney disease, p = 0.029; physical component summary, p = 0.048).","[{'ForeName': 'Hee-Yeon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea, hy-jung@knu.ac.kr.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Statistics, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Yon Su', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Ki', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Pyo', 'Initials': 'JP', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Jeong', 'Initials': 'EJ', 'LastName': 'Ko', 'Affiliation': 'Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dong-Ryeol', 'Initials': 'DR', 'LastName': 'Ryu', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Shin-Wook', 'Initials': 'SW', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Tak', 'Initials': 'JT', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Jang-Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Chan-Duck', 'Initials': 'CD', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Yong-Lim', 'Initials': 'YL', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Sun-Hee', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}]",Nephron,['10.1159/000518364']
1578,34511184,"In Vitro and Clinical Pharmacokinetic Studies of the Effects of Iron-containing Agents on Vadadustat, an Oral Hypoxia-inducible Factor-Prolyl Hydroxylase Inhibitor.","PURPOSE


Vadadustat is an oral hypoxia-inducible factor-prolyl hydroxylase inhibitor approved in Japan for the treatment of anemia in chronic kidney disease. This study investigated drug-drug interactions between vadadustat and oral iron supplements or iron-containing phosphate binders commonly used in Japanese clinical practice by conducting in vitro mechanistic and clinical pharmacokinetic studies.
METHODS


In the in vitro assessment, chelate formation of vadadustat with iron-containing agents was investigated in water and in a fed-state simulated intestinal fluid. Chelate formation was assessed by observation of a chelate-specific color, and the concentration of vadadustat was determined. In the single-dose, open-label, randomized, crossover clinical study, healthy male participants received 150 mg of vadadustat with or without oral iron-containing agents. Pharmacokinetic data were collected for up to 24 hours after vadadustat administration. Participants were monitored for adverse events during the study.
FINDINGS


Vadadustat formed a chelate precipitate with ferrous sulfate and ferric nitrate, as shown by development of a specific bright orange color in water. The proportions of vadadustat dissolved in the supernatant were 2% and 18%, respectively. Vadadustat did not form a chelate precipitate in a fed-state simulated intestinal fluid in the presence of sodium ferrous citrate, ferric citrate hydrate, or sucroferric oxyhydroxide; the proportion of vadadustat in supernatant ranged from 63% to 89%. In the clinical pharmacokinetic study, coadministration of vadadustat with sodium ferrous citrate, ferric citrate hydrate, sucroferric oxyhydroxide, or ferrous sulfate decreased the AUC 0-∞  by 54.0% to 89.7% and C max  by 42.1% to 91.9%. No serious adverse events were reported.
IMPLICATIONS


Chelate formation of vadadustat with iron-containing agents was confirmed by in vitro analysis and depended on the type of iron-containing agent. The AUC 0-∞  and C max  of vadadustat decreased when coadministered with oral iron-containing agents. Our data suggest that the decreases in AUC 0-∞  and C max  are a result of chelation in the gastrointestinal tract; therefore, coadministration of iron-containing agents with vadadustat should use a dosing interval. ClinicalTrials.gov Identifier: NCT03645863.",2021,The AUC 0-∞  and C max  of vadadustat decreased when coadministered with oral iron-containing agents.,['healthy male participants received'],"['150 mg of vadadustat with or without oral iron-containing agents', 'vadadustat with sodium ferrous citrate, ferric citrate hydrate, sucroferric oxyhydroxide, or ferrous sulfate', 'vadadustat and oral iron supplements or iron-containing phosphate binders']","['adverse events', 'serious adverse events', 'AUC 0-∞  and C max  of vadadustat', 'Chelate formation']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4519730', 'cui_str': 'vadadustat'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0066752', 'cui_str': 'monoferrous acid citrate'}, {'cui': 'C0060231', 'cui_str': 'ferric citrate'}, {'cui': 'C3696416', 'cui_str': 'sucroferric oxyhydroxide'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0721124', 'cui_str': 'Iron supplement'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0179302', 'cui_str': 'Binder'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C4519730', 'cui_str': 'vadadustat'}, {'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.0821201,The AUC 0-∞  and C max  of vadadustat decreased when coadministered with oral iron-containing agents.,"[{'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Kokado', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Kawai', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan. Electronic address: kawai.kouji@me.mt-pharma.co.jp.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Nanjo', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Kinoshita', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Kazuoki', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2021.06.013']
1579,34517135,Steroid pretreatment of deceased donors and liver allograft function - Ten years follow-up of a blinded randomized placebo controlled trial.,"BACKGROUND


Within the last decade numerous attempts have been reported in order to expand the donor pool and alleviate organ shortage in the setting of liver transplantation. Aim of this blinded randomized controlled trial was to evaluate the effect of donor steroid pretreatment on outcomes after liver transplantation.
METHODS


We performed an international, multi-center double-blinded randomized placebo controlled trial. Donors received 1000 mg methylprednisone or placebo before organ procurement. Primary endpoint were patient and graft survival. Secondary end points were rate of BPAR and liver functions trajectories after transplantation. Follow up was 10 years.
RESULTS


There was no effect of steroid pretreatment vs. placebo on overall patient survival (50% vs. 46%, p = n.s.) as well as graft survival (47% vs. 51%, p= n.s.). Further donor steroid pretreatment did not alter the rate of biopsy proven acute rejections (34% steroid group vs. 36% placebo, p = n.s.). Evaluating short term and long term graft function, steroid pretreatment had minor effect on immediate liver function trajectories within the first 2 weeks after transplantation. This was not seen in long-term follow up.
CONCLUSION


In conclusion we found no evidence that donor steroid pretreatment translates in improved outcomes after liver transplantation.",2021,"Evaluating short term and long term graft function, steroid pretreatment had minor effect on immediate liver function trajectories within the first 2 weeks after transplantation.",['deceased donors and liver allograft function '],"['placebo', 'methylprednisone or placebo', 'donor steroid pretreatment']","['overall patient survival', 'rate of biopsy proven acute rejections', 'rate of BPAR and liver functions trajectories', 'patient and graft survival', 'immediate liver function trajectories', 'graft survival']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",,0.773449,"Evaluating short term and long term graft function, steroid pretreatment had minor effect on immediate liver function trajectories within the first 2 weeks after transplantation.","[{'ForeName': 'Georg P', 'Initials': 'GP', 'LastName': 'Györi', 'Affiliation': 'Division of Transplantation, Department of Surgery, Medical University of Vienna, Austria. Electronic address: georg.gyoeri@meduniwien.ac.at.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Mathe', 'Affiliation': 'Division of Transplantation, Department of Surgery, Medical University of Vienna, Austria; Semmelweis University Budapest, Dept. of Transplantation and Surgery, Budapest, Hungary.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Jelencsics', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine III, Medical University of Vienna, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Geroldinger', 'Affiliation': 'Center for Medical Statistics and Informatics, Medical University of Vienna, Austria.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Gerlei', 'Affiliation': 'Semmelweis University Budapest, Dept. of Transplantation and Surgery, Budapest, Hungary.'}, {'ForeName': 'Gabriela A', 'Initials': 'GA', 'LastName': 'Berlakovich', 'Affiliation': 'Division of Transplantation, Department of Surgery, Medical University of Vienna, Austria.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106095']
1580,34518035,Efficacy of intermittent topical 5-fluorouracil 5% and oral nicotinamide in the skin field cancerization: a randomized clinical trial.,,2021,,['skin field cancerization'],"['intermittent topical 5-fluorouracil', 'oral nicotinamide']",[],"[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C3215191', 'cui_str': 'Fluorouracil-containing product in cutaneous dose form'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}]",[],,0.185027,,"[{'ForeName': 'Eliane Roio', 'Initials': 'ER', 'LastName': 'Ferreira', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Universidade Estadual Paulista, São Paulo, SP, Brazil.'}, {'ForeName': 'Anna Carolina', 'Initials': 'AC', 'LastName': 'Miola', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Universidade Estadual Paulista, São Paulo, SP, Brazil. Electronic address: anna.c.miola@unesp.br.'}, {'ForeName': 'Thania Rios Rossi', 'Initials': 'TRR', 'LastName': 'Lima', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Universidade Estadual Paulista, São Paulo, SP, Brazil.'}, {'ForeName': 'Juliano Vilaverde', 'Initials': 'JV', 'LastName': 'Schmitt', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Universidade Estadual Paulista, São Paulo, SP, Brazil.'}, {'ForeName': 'Luciana Patricia Fernandes', 'Initials': 'LPF', 'LastName': 'Abbade', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Universidade Estadual Paulista, São Paulo, SP, Brazil.'}, {'ForeName': 'Hélio Amante', 'Initials': 'HA', 'LastName': 'Miot', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Universidade Estadual Paulista, São Paulo, SP, Brazil.'}]",Anais brasileiros de dermatologia,['10.1016/j.abd.2020.09.012']
1581,34523108,The association of prothrombin complex concentrates with postoperative outcomes in cardiac surgery: an observational substudy of the FIBRES randomized controlled trial.,"PURPOSE


The mainstay of therapy for coagulation factor deficiency in cardiac surgical patients is frozen plasma (FP); however, prothrombin complex concentrates (PCCs) may offer logistical and safety advantages. As there is limited comparative evidence, we conducted this study to explore the association of comparable PCC or FP doses with transfusion and outcomes.
METHODS


This was a post hoc analysis of a multicentre randomized trial comparing fibrinogen concentrate with cryoprecipitate (FIBRES trial) in bleeding cardiac surgical patients. This analysis included 415 patients who received only PCC (n = 72; 17%) or only FP (n = 343; 83%) for factor replacement. The main outcomes of interest were red blood cell (RBC) and platelet transfusion within 24 hr of cardiopulmonary bypass. Secondary outcomes included postoperative adverse events. Associations were examined by hierarchical generalized estimating equation models adjusted for demographic and surgical characteristics.
RESULTS


The median [interquartile range (IQR)] PCC dose was 1,000 [1,000-2,000] units, while the median [IQR] FP dose was 4 [2-6] units. Each unit of FP was independently associated with increased adjusted odds of RBC (1.60; 95% confidence interval [CI], 1.36 to 1.87; P < 0.01) and platelet transfusion (1.40; 95% CI, 1.15 to 1.69; P < 0.01) while each 500 units of PCC was independently associated with reduced adjusted odds of RBC (0.67; 95% CI, 0.50 to 0.90; P < 0.01) and platelet transfusion (0.80; 95% CI, 0.70 to 0.92; P < 0.01). Adverse event rates were comparable.
CONCLUSIONS


In cardiac surgical patients with post-cardiopulmonary bypass bleeding, PCC use was associated with lower RBC and platelet transfusion than FP use was. Prospective, randomized clinical trials comparing FP with PCC in this setting are warranted.",2021,"In cardiac surgical patients with post-cardiopulmonary bypass bleeding, PCC use was associated with lower RBC and platelet transfusion than FP use was.","['bleeding cardiac surgical patients', 'cardiac surgery', 'cardiac surgical patients', '415 patients who received only PCC (n = 72; 17%) or only FP (n = 343; 83%) for factor replacement']","['fibrinogen concentrate with cryoprecipitate (FIBRES trial', 'prothrombin complex concentrates', 'PCC', 'FP with PCC']","['red blood cell (RBC) and platelet transfusion within 24 hr of cardiopulmonary bypass', 'postoperative adverse events', 'Adverse event rates', 'platelet transfusion', 'median [interquartile range (IQR', 'RBC and platelet transfusion']","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4048712', 'cui_str': 'factor IX complex'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0086818', 'cui_str': 'Platelet transfusion'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",415.0,0.170787,"In cardiac surgical patients with post-cardiopulmonary bypass bleeding, PCC use was associated with lower RBC and platelet transfusion than FP use was.","[{'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Bartoszko', 'Affiliation': ""Department of Anesthesia and Pain Management, Toronto General Hospital - University Health Network, Sinai Health System, Women's College Hospital,, University of Toronto, 200 Elizabeth Street, 3EN-464, Toronto, ON, M5G 2C4, Canada. Justyna.bartoszko@uhn.ca.""}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Callum', 'Affiliation': 'Department of Pathology and Molecular Medicine, Kingston Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Karkouti', 'Affiliation': ""Department of Anesthesia and Pain Management, Toronto General Hospital - University Health Network, Sinai Health System, Women's College Hospital,, University of Toronto, 200 Elizabeth Street, 3EN-464, Toronto, ON, M5G 2C4, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-021-02100-4']
1582,34521554,"Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL).","OBJECTIVE


The randomized phase 3 CORAIL trial evaluated whether lurbinectedin improved progression-free survival (PFS) compared to pegylated liposomal doxorubicin (PLD) or topotecan in patients with platinum-resistant ovarian cancer.
METHODS


Patients were randomly assigned (1:1) to lurbinectedin 3.2 mg/m 2  1-h i.v. infusion q3wk (experimental arm), versus PLD 50 mg/m 2  1-h i.v. infusion q4wk or topotecan 1.50 mg/m 2  30-min i.v. infusion Days 1-5 q3wk (control arm). Stratification factors were PS (0 vs. ≥1), prior PFI (1-3 months vs. >3 months), and prior chemotherapy lines (1-2 vs. 3). The primary endpoint was PFS by Independent Review Committee in all randomized patients. This study was registered with ClinicalTrials.gov, NCT02421588.
RESULTS


442 patients were randomized: 221 in lurbinectedin arm and 221 in control arm (127 PLD and 94 topotecan). With a median follow-up of 25.6 months, median PFS was 3.5 months (95% CI, 2.1-3.7) in the lurbinectedin arm and 3.6 months (95% CI, 2.7-3.8) in the control arm (stratified log-rank p = 0.6294; HR = 1.057). Grade ≥ 3 treatment-related adverse events (AEs) were most frequent in the control arm: 64.8% vs. 47.9% (p = 0.0005), mainly due to hematological toxicities. The most common grade ≥ 3 AEs were: fatigue (7.3% of patients) and nausea (5.9%) with lurbinectedin; mucosal inflammation (8.5%) and fatigue (8.0%) in the control arm.
CONCLUSIONS


The primary endpoint of improvement in PFS was not met. Lurbinectedin showed similar antitumor efficacy and was better tolerated than current standard of care in patients with platinum-resistant ovarian cancer.",2021,Grade ≥ 3 treatment-related adverse events (AEs) were most frequent in the control arm: 64.8% vs. 47.9% (,"['patients with platinum-resistant ovarian cancer', 'Patients', '442 patients were randomized: 221 in']","['pegylated liposomal doxorubicin (PLD) or topotecan', 'Lurbinectedin versus pegylated liposomal doxorubicin or topotecan', 'lurbinectedin 3.2\xa0mg/m 2  1-h i.v', 'PLD 50', 'lurbinectedin', 'infusion q4wk or topotecan 1.50', 'Lurbinectedin']","['Grade\xa0≥\xa03 treatment-related adverse events (AEs', 'progression-free survival (PFS', 'antitumor efficacy', 'PFS', 'hematological toxicities', 'nausea', 'median PFS', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C1449035', 'cui_str': 'SPRR2A protein, human'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",442.0,0.120645,Grade ≥ 3 treatment-related adverse events (AEs) were most frequent in the control arm: 64.8% vs. 47.9% (,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gaillard', 'Affiliation': 'Duke Cancer Institute, Durham, USA. Electronic address: stephanie.gaillard@jhmi.edu.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'GINECO, Centre Léon Bérard and University Claude Bernard, Lyon, France.'}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'University of Milan-Bicocca and European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Fernandez', 'Affiliation': 'Pharma Mar S.A., Clinical R&D, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Alfaro', 'Affiliation': 'Pharma Mar S.A., Clinical R&D, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Kahatt', 'Affiliation': 'Pharma Mar S.A., Clinical R&D, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nieto', 'Affiliation': 'Pharma Mar S.A., Clinical R&D, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zeaiter', 'Affiliation': 'Pharma Mar S.A., Clinical R&D, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Aracil', 'Affiliation': 'Pharma Mar S.A., Clinical R&D, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vidal', 'Affiliation': 'Syneos Health, Barcelona, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Pardo-Burdalo', 'Affiliation': 'Institut Catala Oncologia, Hospital Duran i Reynals, Barcelona, Spain.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Papai', 'Affiliation': 'Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kristeleit', 'Affiliation': 'University College of London Hospital; London, United Kingdom.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'James Comprehensive Cancer Center - Wexner Medical Center, The Ohio State University, Columbus, USA.'}, {'ForeName': 'Ivor', 'Initials': 'I', 'LastName': 'Benjamin', 'Affiliation': 'Arizona Center for Cancer Care, Glendale, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pautier', 'Affiliation': 'Institut Gustave-Roussy, Villejuif, France.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano, and Fondazione Policlinico Gemelli IRCCS, Rome, Italy.'}]",Gynecologic oncology,['10.1016/j.ygyno.2021.08.032']
1583,34521390,Body weight changes in patients with type 2 diabetes and a recent acute coronary syndrome: an analysis from the EXAMINE trial.,"BACKGROUND


Patients with type 2 diabetes (T2D) may experience frequent body weight changes over time. The prognostic impact of these weight changes (gains or losses) requires further study.
AIMS


To study the associations between changes in body weight (intentional or unintentional) with subsequent outcomes.
METHODS


The EXAMINE trial included 5380 patients with T2D and a recent acute coronary syndrome, who were randomized to alogliptin or placebo. Time-updated Cox models and mixed effects models were used to test the associations between changes in body weight and subsequent outcomes over a median follow-up of 1.6 (1.0-2.1) years.
RESULTS


During the post-randomization follow-up period, 1044 patients (19.4%) experienced a weight loss ≥ 5% of baseline weight, 2677 (49.8%) had a stable weight, and 1659 (30.8%) had a ≥ 5 % weight gain. Patients with weight loss were more frequently women and had more co-morbid conditions. In contrast, patients who gained ≥ 5% weight were more frequently men with less co-morbid conditions. A weight loss ≥ 5% was independently associated with a higher risk of subsequent adverse outcomes, including all-cause mortality: adjusted HR (95% CI) = 1.79 (1.33-2.42), P < 0.001. Similar associations were found for cardiovascular mortality, the composite of cardiovascular mortality or heart failure hospitalization, and the primary outcome. A weight gain ≥ 5% was independently associated with an increase in the risk of subsequent cardiovascular mortality or heart failure hospitalization only: adjusted HR (95% CI) = 1.34 (1.02-1.76), P = 0.033.
CONCLUSIONS


In patients with T2D who had a recent ACS/MI, a ≥ 5% loss of body weight was associated with a higher risk of subsequent cardiovascular events and mortality.",2021,"A weight loss ≥ 5% was independently associated with a higher risk of subsequent adverse outcomes, including all-cause mortality: adjusted HR (95% CI) = 1.79 (1.33-2.42), P < 0.001.","['Patients with type 2 diabetes (T2D', '5380 patients with T2D and a recent acute coronary syndrome', 'patients with T2D who had a recent ACS/MI', 'patients with type 2 diabetes and a recent acute coronary syndrome']",['alogliptin or placebo'],"['cardiovascular mortality, the composite of cardiovascular mortality or heart failure hospitalization', 'subsequent cardiovascular events and mortality', 'risk of subsequent cardiovascular mortality', 'body weight (intentional or unintentional', 'weight loss', 'Body weight changes', 'body weight', 'body weight and subsequent outcomes', 'stable weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}]","[{'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",5380.0,0.125649,"A weight loss ≥ 5% was independently associated with a higher risk of subsequent adverse outcomes, including all-cause mortality: adjusted HR (95% CI) = 1.79 (1.33-2.42), P < 0.001.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Centre DInvestigation Clinique-Plurithématique Inserm CIC-P 1433, Inserm U1116, CHRU Nancy hopitaux de Brabois, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Université de Lorraine, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu, 4 Rue du Morvan, 54500, Vandoeuvre lès Nancy, France. j.ferreira@chru-nancy.fr.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'Centre DInvestigation Clinique-Plurithématique Inserm CIC-P 1433, Inserm U1116, CHRU Nancy hopitaux de Brabois, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Université de Lorraine, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu, 4 Rue du Morvan, 54500, Vandoeuvre lès Nancy, France.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'Cytel Corporation, Cambridge, MA, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Centre DInvestigation Clinique-Plurithématique Inserm CIC-P 1433, Inserm U1116, CHRU Nancy hopitaux de Brabois, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Université de Lorraine, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu, 4 Rue du Morvan, 54500, Vandoeuvre lès Nancy, France.'}]",Cardiovascular diabetology,['10.1186/s12933-021-01382-8']
1584,34520881,Evaluation of the effectiveness in teeth whitening of a single session with 6% hydrogen peroxide Laser/LED system.,"BACKGROUND


Due to the current importance of dental whitening, multiple studies have been carried out in order to achieve an efficient, effective, and innocuous procedure. This study aimed to compare the effectiveness and sensitivity of in-office dental bleaching with one versus two applications of 6% hydrogen peroxide (HP) gel with nitrogen titanium dioxide (TiO 2 ) nanoparticles activated by LED/Laser lamp in a single-session.
METHODS


This RCT with a split-mouth design was performed in twenty-seven volunteers. The in-office dental bleaching technique was performed using 6% HP with nitrogen TiO 2  nanoparticles. In each patient, groups were randomized by hemiarch: Group 1 received one application of 72 minutes and Group 2 received two applications of 36 minutes, both groups in a single-session.
RESULTS


There were no significant differences in the effectiveness of a single-session with one or two applications of 6% HP with nitrogen TiO 2  nanoparticles between both groups(p>0.05). A positive and increase of ∆E value was observed in both groups. Group 1 showed an increase of 4.45 in the immediate measurement, remaining at 4.41 until the one-week control, to increase up to an ∆E of 4.99 at one-month control. Group 2 showed a sustained increase of 4.02 units in the immediate control until reaching the maximum value of 5.46 units of ∆E at one-month control.
CONCLUSION


One session single application protocol of 6% Hydrogen Peroxide gel with nanoparticulate TiO 2  activated by LED/Laser is effective and efficient for dental bleaching.",2021,There were no significant differences in the effectiveness of a single-session with one or two applications of 6% HP with nitrogen TiO 2  nanoparticles between both groups(p>0.05).,['twenty-seven volunteers'],"['hydrogen peroxide Laser/LED system', '6% hydrogen peroxide (HP) gel with nitrogen titanium dioxide (TiO 2 ) nanoparticles activated by LED/Laser lamp', 'Hydrogen Peroxide gel with nanoparticulate TiO 2  activated by LED']",['∆E value'],"[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0076733', 'cui_str': 'titanium dioxide'}, {'cui': 'C2355432', 'cui_str': 'oxo(5,10,15,20-tetra(4-pyridyl)porphyrinato)titanium(IV)'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}]",27.0,0.0145314,There were no significant differences in the effectiveness of a single-session with one or two applications of 6% HP with nitrogen TiO 2  nanoparticles between both groups(p>0.05).,"[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Bersezio', 'Affiliation': 'Restorative Dentistry Departament, Faculty of Dentistry, University of Chile. Electronic address: cberseziom@odontologia.uchile.cl.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Pardo', 'Affiliation': 'PhD program, Faculty of Dentistry, University of Chile, Chile; Faculty of Dentistry, Universidad de Los Andes, Santiago, Chile; Universidad de Valparaíso, Faculty of Dentistry, Valparaíso, Chile.. Electronic address: carolinapa@gmail.com.'}, {'ForeName': 'Scarlet', 'Initials': 'S', 'LastName': 'Miranda', 'Affiliation': 'Restorative Dentistry Departament, Faculty of Dentistry, University of Chile. Electronic address: scarlette.miranda@ug.uchile.cl.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Medeiros Maran', 'Affiliation': 'Universidad de Valparaíso, Faculty of Dentistry, Valparaíso, Chile.; Department of Restorative Dentistry, School of Dentistry, State University of Western Paraná, Cascavel, PR, Brazil. Electronic address: medeiros.bianca@hotmail.com.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Jorquera', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, Universidad de Los Andes, Santiago, Chile. Electronic address: gjorquera@uandes.cl.'}, {'ForeName': 'Aurélio', 'Initials': 'A', 'LastName': 'Rosa da Silva', 'Affiliation': 'Postgraduate Program in Integrated Dental Sciences, University of Cuiaba´, Brazil. Electronic address: aurelio_rsj@hotmail.com.'}, {'ForeName': 'Mateus', 'Initials': 'M', 'LastName': 'Tonetto Rodrigues', 'Affiliation': 'Postgraduate Program in Integrated Dental Sciences, University of Cuiaba´, Brazil. Electronic address: mateus_brt@hotmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Fernández', 'Affiliation': 'Restorative Dentistry Departament, Faculty of Dentistry, University of Chile; Instituto de Ciencias Biomédicas, Universidad Autónoma de Chile, Chile. Electronic address: edofdez@yahoo.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102532']
1585,34524086,A Social Media Group Cognitive Behavioral Therapy Intervention to Prevent Depression in Perinatal Youth: Stakeholder Interviews and Intervention Design.,"BACKGROUND


Adolescents and young adults aged <25 years (youth) are at a higher risk of perinatal depression than older adults, and they experience elevated barriers to in-person care. Digital platforms such as social media offer an accessible avenue to deliver group cognitive behavioral therapy (CBT) to perinatal youth.
OBJECTIVE


We aim to develop the Interactive Maternal Group for Information and Emotional Support (IMAGINE) intervention, a facilitated social media group CBT intervention to prevent perinatal depression in youth in the United States, by adapting the Mothers and Babies (MB) course, an evidence-based in-person group CBT intervention. In this study, we report perspectives of youth and health care providers on perinatal youths' mental health needs and document how they informed IMAGINE design.
METHODS


We conducted 21 semistructured in-depth individual interviews with 10 pregnant or postpartum youths aged 14-24 years and 6 health care workers. All interviews were recorded, transcribed, and analyzed using deductive and inductive approaches to characterize perceptions of challenges and facilitators of youth perinatal mental health. Using a human-centered design approach, stakeholder perspectives were incorporated into the IMAGINE design. We classified MB adaptations to develop IMAGINE according to the Framework for Modification and Adaptation, reporting the nature, timing, reason, and goal of the adaptations.
RESULTS


Youth and health care workers described stigma associated with young pregnancy and parenting, social isolation, and lack of material resources as significant challenges to youth mental wellness. They identified nonjudgmental support, peer companionship, and access to step-by-step guidance as facilitators of youth mental wellness. They endorsed the use of a social media group to prevent perinatal depression and recommended that IMAGINE facilitate peer support, deliver content asynchronously to accommodate varied schedules, use a confidential platform, and facilitate the discussion of topics beyond the MB curriculum, such as navigating support resources or asking medical questions. IMAGINE was adapted from MB to accommodate stakeholder recommendations and facilitate the transition to web-based delivery. Content was tailored to be multimodal (text, images, and video), and the language was shortened and simplified. All content was designed for asynchronous engagement, and redundancy was added to accommodate intermittent access. The structure was loosened to allow the intervention facilitator to respond in real time to topics of interest for youth. A social media platform was selected that allows multiple conversation channels and conceals group member identity. All adaptations sought to preserve the fidelity of the MB core components.
CONCLUSIONS


Our findings highlight the effect of stigmatization of young pregnancy and social determinants of health on youth perinatal mental health. Stakeholders supported the use of a social media group to create a supportive community and improve access to evidence-based depression prevention. This study demonstrates how a validated intervention can be tailored to this unique group.",2021,"RESULTS


Youth and health care workers described stigma associated with young pregnancy and parenting, social isolation, and lack of material resources as significant challenges to youth mental wellness.","['10 pregnant or postpartum youths aged 14-24 years and 6 health care workers', ""youth and health care providers on perinatal youths' mental health needs"", 'Perinatal Youth', 'Adolescents and young adults aged <25 years (youth']","['Interactive Maternal Group for Information and Emotional Support (IMAGINE) intervention, a facilitated social media group CBT intervention', 'Social Media Group Cognitive Behavioral Therapy Intervention']",[],"[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.014885,"RESULTS


Youth and health care workers described stigma associated with young pregnancy and parenting, social isolation, and lack of material resources as significant challenges to youth mental wellness.","[{'ForeName': 'Anupa', 'Initials': 'A', 'LastName': 'Gewali', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Dachelet', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Healy', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Marimirca', 'Initials': 'M', 'LastName': 'Jean-Baptiste', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Harridan', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Evans', 'Affiliation': ""Division of Adolescent Medicine, Seattle Children's Hospital, Seattle, WA, United States.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Unger', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Amritha', 'Initials': 'A', 'LastName': 'Bhat', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Tandon', 'Affiliation': 'Department of Medical Social Sciences, Northwestern Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Keshet', 'Initials': 'K', 'LastName': 'Ronen', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}]",JMIR mental health,['10.2196/26188']
1586,34526255,"Endoscopic treatment of primary vesicoureteral reflux in children with two different bulking agents, high success and low complication rates: Comparison of Dexell and Vantris.","INTRODUCTION AND OBJECTIVES


To compare the results in terms of efficacy and safety of the endoscopic management for vesicoureteral reflux (VUR) in two different standardized primary VUR cohorts treated with Dexell and Vantris.
PATIENTS


128 refluxing renal units (RRU) in 87 patients with primary VUR (64 females, 23 males). Patients with secondary VUR and severe bladder and bowel dysfunction were excluded. A total of 22 continent children with mild bladder-bowel dysfunction underwent bladder-bowel training before the implantation. All procedures were performed in the presence of sterile urine using a conventional subureteral transurethral injection technique.
RESULTS


There were no statistically significant differences between groups in terms of mean age, sex, RRU side,  99m Tc-DMSA uptake, and reflux grade. The overall resolution rates based on the number of RRUs for up to three endoscopic treatments were 80% (56/70) in Dexell group and 94.8% (55/58) in Vantris group (P = .012). No postoperative recurrences or vesicoureteral junction obstructions were seen in any group.
CONCLUSIONS


Dexell and Vantris provided an effective and safe endoscopic VUR treatment in the early and mid-term follow up of children with primary VUR. The effectiveness of these substances, which can produce different mass effects with different particle sizes, in safe VUR resolution, needs further investigations.",2021,"There were no statistically significant differences between groups in terms of mean age, sex, RRU side,  99m Tc-DMSA uptake, and reflux grade.","['Patients with secondary VUR and severe bladder and bowel dysfunction were excluded', '22 continent children with mild bladder-bowel dysfunction underwent bladder-bowel training before the implantation', 'vesicoureteral reflux (VUR) in two different standardized primary VUR cohorts treated with Dexell and Vantris', '128 refluxing renal units (RRU) in 87 patients with primary VUR (64 females, 23 males']","['endoscopic management', 'conventional subureteral transurethral injection technique']","['mean age, sex, RRU side,  99m Tc-DMSA uptake, and reflux grade', 'postoperative recurrences or vesicoureteral junction obstructions', 'efficacy and safety', 'overall resolution rates', 'number of RRUs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteric reflux'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0150156', 'cui_str': 'Bowel training'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2355419', 'cui_str': 'Vantris'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0303611', 'cui_str': 'Technetium 99m'}, {'cui': 'C0012384', 'cui_str': 'Succimer'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",87.0,0.0167199,"There were no statistically significant differences between groups in terms of mean age, sex, RRU side,  99m Tc-DMSA uptake, and reflux grade.","[{'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Doğan', 'Affiliation': 'Departamento de Cirugía Pediátrica, Facultad de Medicina, Universidad Erciyes, Kayseri, Turkey. Electronic address: drkarden@gmail.com.'}, {'ForeName': 'K U', 'Initials': 'KU', 'LastName': 'Özkan', 'Affiliation': 'Departamento de Cirugía Pediátrica, Facultad de Medicina, Universidad Erciyes, Kayseri, Turkey.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Güler', 'Affiliation': 'Departamento de Cirugía Pediátrica, Facultad de Medicina, University of Sütçü İmam, Kahramanmaras, Turkey.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Karakaya', 'Affiliation': 'Departamento de Cirugía Pediátrica, Facultad de Medicina, University of Sütçü İmam, Kahramanmaras, Turkey.'}]",Actas urologicas espanolas,['10.1016/j.acuroe.2021.07.002']
1587,34528337,Effect of Helicobacter pylori eradication therapy on clinical and laboratory biomarkers associated with gastric damage in healthy school-aged children: A randomized non-blinded trial.,"OBJECTIVES


Helicobacter pylori (H. pylori) is the primary cause of gastric cancer and eradication in healthy adults has proven effective in decreasing cancer incidence. H. pylori is acquired largely in early childhood, however, the benefits of eradication in children are controversial. We aimed to determine the effect of H. pylori eradication on clinical and laboratory markers associated with gastric damage in apparently healthy school-aged children.
METHODS


This was a pilot non-blinded trial including 61 children persistently infected with H. pylori who were randomized to eradication/no treatment and followed for at least 12 months, evaluating clinical and blood markers (Pepsinogen I (PGI) and II (PGII) determined by ELISA) associated with gastric damage. The treatment consisted of a sequential scheme including 7 days of omeprazole + amoxicillin followed by 7 days of omeprazole + clarithromycin + metronidazole; adherence and tolerance were surveyed. Eradication rates were assessed by stool antigen detection or urea breath test 1 month following treatment every 4 months thereafter to detect reinfection.
RESULTS


Eradication occurred in 30/31 treated children (median age: 8.8, range: 7.9-10.8) and in 0/30 non-treated controls (median age: 8.6, range: 7.9-11) (p < .001). Treatment was associated with mild transient symptoms (altered taste, nocturnal upper abdominal pain, nausea, and diarrhea). Baseline frequency of symptoms was low and eradication did not change symptoms compared to controls. PGI, PGII, and anti-H. pylori seropositivity were similar in both groups at baseline and significantly decreased only in eradicated patients; PGI (92.5 vs. 74.4, p < .001), PGII (15.2 vs. 8.9, p < .001) levels, and frequency of anti-H. pylori seropositivity (100 vs. 68%, p < .001) respectively. Four eradicated children (13%) were reinfected during follow-up.
CONCLUSIONS


H. pylori eradication therapy in apparently asymptomatic school-aged children was well tolerated and associated with decreased serum PGI and PGII levels. Future studies should expand on the middle-long-term effect of early H. pylori eradication, especially on preventing gastric cancer.",2021,"PGI, PGII, and anti-H. pylori seropositivity were similar in both groups at baseline and significantly decreased only in eradicated patients; PGI (92.5 vs. 74.4, p < .001), PGII (15.2 vs. 8.9, p < .001) levels, and frequency of anti-H. pylori seropositivity (100 vs. 68%, p < .001) respectively.","['healthy adults', 'healthy school-aged children', 'apparently healthy school-aged children', 'apparently asymptomatic school-aged children', '61 children persistently infected with H.\xa0pylori']","['omeprazole\xa0+\xa0clarithromycin\xa0+\xa0metronidazole', 'Helicobacter pylori eradication therapy', 'omeprazole\xa0+\xa0amoxicillin']","['Eradication', 'clinical and blood markers (Pepsinogen I (PGI) and II (PGII) determined by ELISA) associated with gastric damage', 'mild transient symptoms (altered taste, nocturnal upper abdominal pain, nausea, and diarrhea', 'PGII', 'frequency of anti-H.\xa0pylori seropositivity', 'Eradication rates', 'serum PGI and PGII levels', 'PGI, PGII, and anti-H.\xa0pylori seropositivity']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0077923', 'cui_str': 'Pepsinogen I'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0232492', 'cui_str': 'Upper abdominal pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0523817', 'cui_str': 'Pepsinogen II measurement'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",61.0,0.0854024,"PGI, PGII, and anti-H. pylori seropositivity were similar in both groups at baseline and significantly decreased only in eradicated patients; PGI (92.5 vs. 74.4, p < .001), PGII (15.2 vs. 8.9, p < .001) levels, and frequency of anti-H. pylori seropositivity (100 vs. 68%, p < .001) respectively.","[{'ForeName': 'Yalda', 'Initials': 'Y', 'LastName': 'Lucero', 'Affiliation': 'Microbiology and Mycology Program, Institute of Biomedical Sciences, Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Anne J', 'Initials': 'AJ', 'LastName': 'Lagomarcino', 'Affiliation': 'Microbiology and Mycology Program, Institute of Biomedical Sciences, Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Torres', 'Affiliation': 'Department of Pediatrics and Pediatric Surgery (Eastern Campus), Hospital Dr. Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Roessler', 'Affiliation': 'Clínica Alemana de Santiago, Faculty of Medicine, Universidad del Desarrollo-Clínica Alemana, Santiago, Chile.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Mamani', 'Affiliation': 'Microbiology and Mycology Program, Institute of Biomedical Sciences, Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Sergio A', 'Initials': 'SA', 'LastName': 'George', 'Affiliation': 'Microbiology and Mycology Program, Institute of Biomedical Sciences, Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Huerta', 'Affiliation': 'Microbiology and Mycology Program, Institute of Biomedical Sciences, Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Department of Pediatrics and Pediatric Surgery (Northern Campus), Hospital Dr. Roberto del Río Hospital, Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': ""O'Ryan G"", 'Affiliation': 'Microbiology and Mycology Program, Institute of Biomedical Sciences, Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}]",Helicobacter,['10.1111/hel.12853']
1588,34547486,Immunogenicity of 2-dose pre-exposure rabies vaccine co-administered with quadrivalent influenza vaccine in children.,"OBJECTIVES


The World Health Organization recommends a 2-dose rabies pre-exposure prophylaxis (PrEP) regimen. This study aimed to compare the immunogenicity of rabies PrEP regimens co-administered with inactivated quadrivalent influenza vaccine (IIV4).
METHODS


Children aged 3 to 9 years were randomly assigned (2:2:1) to receive 0.25 mL of chromatographically purified Vero cell rabies vaccine intramuscularly: Group A at day 0, 7 with IIV4; Group B at day 0, 28 with IIV4; Group C at day 0, 7. A booster-dose of CPRV was given on day 365. Primary outcome was the proportion of children with protective rabies virus neutralizing antibody (RVNA) ≥ 0.5 IU/mL, on day 42 and 7 days post-booster.
RESULTS


From November 2019 to January 2020; 100 children with a median age (IQR) of 5.4 years (4.8-7.3) were enrolled. All participants achieved protective RVNA titers on day 42 and 7-days post booster. Geometric mean titers (GMT) at day 42 were Group A, 8.98(95%CI 7.06-11.42); Group B, 23.89(95%CI 19.33-29.51); Group C, 9.94(95%CI 7.03-14.06). Likewise, RVNA GMT at 7 days post-booster were Group A, 42.53(95%CI 18.41-66.64); Group B, 23.19(95%CI 17.28-29.10); Group C, 57.75 (95%CI 35.86-79.67).
CONCLUSIONS


The 2-dose PrEP regimen of rabies vaccine produces adequate immune response either 0,7 or 0, 28 regimens.",2021,"Primary outcome was the proportion of children with protective rabies virus neutralizing antibody (RVNA) ≥ 0.5 IU/mL, on day 42 and 7 days post-booster.
","['From November 2019 to January 2020; 100 children with a median age (IQR) of 5.4 years (4.8-7.3) were enrolled', 'Children aged 3 to 9 years', 'children']","['chromatographically purified Vero cell rabies vaccine intramuscular', '2-dose pre-exposure rabies vaccine co-administered with quadrivalent influenza vaccine', 'rabies vaccine', 'CPRV', 'rabies PrEP regimens co-administered with inactivated quadrivalent influenza vaccine (IIV4']","['protective RVNA titers', 'Geometric mean titer (GMT', 'proportion of children with protective rabies virus neutralizing antibody (RVNA) ≥ 0.5 IU/mL, on day 42 and 7 days post-booster', 'Immunogenicity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517765', 'cui_str': '4.8'}]","[{'cui': 'C0042542', 'cui_str': 'Vero Cells'}, {'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0034494', 'cui_str': 'Rabies'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0034497', 'cui_str': 'Rabies virus'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]",100.0,0.195156,"Primary outcome was the proportion of children with protective rabies virus neutralizing antibody (RVNA) ≥ 0.5 IU/mL, on day 42 and 7 days post-booster.
","[{'ForeName': 'Napaporn', 'Initials': 'N', 'LastName': 'Chantasrisawad', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Watsamon', 'Initials': 'W', 'LastName': 'Jantarabenjakul', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Thai Red Cross Emerging Infectious Diseases Clinical Center (TRC-EID), King Chulalongkorn Memorial Hospital, Bangkok, Thailand. Electronic address: Watsamon.j@chula.ac.th.'}, {'ForeName': 'Suvaporn', 'Initials': 'S', 'LastName': 'Anugulruengkitt', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Suda', 'Initials': 'S', 'LastName': 'Punrin', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Kornvika', 'Initials': 'K', 'LastName': 'Limsuwun', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Panadda', 'Initials': 'P', 'LastName': 'Sawangsinth', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Chayapa', 'Initials': 'C', 'LastName': 'Phasomsap', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Jiratchaya', 'Initials': 'J', 'LastName': 'Sophonphan', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Chitsanu', 'Initials': 'C', 'LastName': 'Pancharoen', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.09.025']
1589,34547471,Photodynamic therapy using methylene blue and intense pulsed light versus intense pulsed light alone in treatment of verruca: A randomized controlled study.,"BACKGROUND


Many therapeutic modalities are available for treatment of warts, but no single therapy is universally effective. Photodynamic therapy (PDT) using intralesional methylene blue (MB) followed by intense pulsed light (IPL) could be a successful option for treatment by several mechanisms.
METHODS


This prospective randomized controlled trial was carried out on eighty patients with verrucae. Patients were randomized into three groups; group A (30 patients) received MB/IPL/PDT sessions, group B (30 Patients) received IPL sessions, and group C (control). Response was assessed by clinical and dermoscopy score (0,1, 2, or 3 according to extent of clinical and dermoscopic resolution), cure rate (percent of verrucae clinically and dermoscopy cleared), and imageJ analysis (surface area of wart and haemorrhagic structures or vessels).
RESULTS


Clinical and dermoscopic clearance was achieved in 43.3% and 20% of patients in groups A and B respectively. Cure rate was 40.9% for group A compared to 23.4% for group B. ImageJ analysis revealed more reduction of surface area in group A being 80.05 ± 27.12% for verrucae and 89.28 ± 19.19% for vessels and haemorrhagic dots compared to 48.16 ± 34.21% and 65.99 ± 30.58% in group B.
CONCLUSIONS


MB/IPL/PDT is an effective option for treatment of warts with a success rate of around 40%, based on clinical and dermoscopic assessment. The efficacy was found to be higher on using imageJ utilizing both the surface area of the wart and surface area of vessels and haemorrhagic dots with the latter being more effected by treatment.",2021,"RESULTS


Clinical and dermoscopic clearance was achieved in 43.3% and 20 % of patients in groups A and B respectively.","['verruca', 'eighty patients with verrucae']","['Photodynamic therapy using methylene blue and intense pulsed light versus intense pulsed light alone', 'MB/IPL/PDT sessions', 'IPL sessions', 'Photodynamic therapy (PDT) using intralesional methylene blue (MB) followed by intense pulsed light (IPL']","['cure rate (percent of verrucae clinically and dermoscopy cleared), and imageJ analysis (surface area of wart and haemorrhagic structures or vessels', 'Cure rate', 'dermoscopic clearance', 'reduction of surface area']","[{'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C1449565', 'cui_str': 'Dermatoscopy'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",80.0,0.0331359,"RESULTS


Clinical and dermoscopic clearance was achieved in 43.3% and 20 % of patients in groups A and B respectively.","[{'ForeName': 'Sarah Nour Eldin', 'Initials': 'SNE', 'LastName': 'Hassan', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, University of Alexandria, Elkartoum Square, Elmessalah 21521 Alexandria, Egypt.'}, {'ForeName': 'Tarek Mahmoud', 'Initials': 'TM', 'LastName': 'Hussein', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, University of Alexandria, Elkartoum Square, Elmessalah 21521 Alexandria, Egypt.'}, {'ForeName': 'Marwa ELsaeed', 'Initials': 'ME', 'LastName': 'Eldeeb', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, University of Alexandria, Elkartoum Square, Elmessalah 21521 Alexandria, Egypt. Electronic address: marwa.eldeeb16@alexmed.edu.eg.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102541']
1590,34547400,Anterior insula morphology and vulnerability to psychopathology-related symptoms in response to acute inflammation.,"INTRODUCTION


The role of inflammation in common psychiatric diseases is now well acknowledged. However, the factors and mechanisms underlying inter-individual variability in the vulnerability to develop psychopathology-related symptoms in response to inflammation are not well characterized. Herein, we aimed at investigating morphological brain regions central for interoception and emotion regulation, and if these are associated with acute inflammation-induced sickness and anxiety responses.
METHODS


Systemic inflammation was induced using an intravenous injection of lipopolysaccharide (LPS) at a dose of 0.6 ng/kg body weight in 28 healthy individuals, while 21 individuals received an injection of saline (placebo). Individuals' gray matter volume was investigated by automated voxel-based morphometry technique on T1-weighted anatomical images derived from magnetic resonance imaging (MRI). Plasma concentrations of TNF-α and IL-6, sickness symptoms (SicknessQ), and state anxiety (STAI-S) were measured before and after the injection.
RESULTS


A stronger sickness response to LPS was significantly associated with a larger anterior insula gray matter volume, independently from increases in cytokine concentrations, age, sex and body mass index (R 2  = 65.6%). Similarly, a greater LPS-induced state anxiety response was related to a larger anterior insula gray matter volume, and also by a stronger increase in plasma TNF-α concentrations (R 2  = 40.4%).
DISCUSSION


Anterior insula morphology appears central in the sensitivity to develop symptoms of sickness and anxiety in response to inflammation, and could thus be one risk factor in inflammation-related psychopathologies. Because of the limited sample size, the current results need to be replicated.",2021,"A stronger sickness response to LPS was significantly associated with a larger anterior insula gray matter volume, independently from increases in cytokine concentrations, age, sex and body mass index (R 2 =65.6%).","['28 healthy individuals, while 21 individuals received an']","['injection of saline (placebo', 'lipopolysaccharide (LPS']","['Plasma concentrations of TNF-α and IL-6, sickness symptoms (SicknessQ), and state anxiety (STAI-S', 'plasma TNF-α concentrations', 'state anxiety response', 'cytokine concentrations, age, sex and body mass index']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",28.0,0.0240241,"A stronger sickness response to LPS was significantly associated with a larger anterior insula gray matter volume, independently from increases in cytokine concentrations, age, sex and body mass index (R 2 =65.6%).","[{'ForeName': 'Kristoffer N T', 'Initials': 'KNT', 'LastName': 'Månsson', 'Affiliation': 'Center for Lifespan Psychology, Max Planck Institute for Human Development, Berlin, Germany; Max Planck UCL Centre for Computational Psychiatry and Ageing Research, Berlin/London, Germany/United Kingdom; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Center for Cognitive and Computational Neuropsychiatry, Karolinska Institutet, Stockholm, Sweden. Electronic address: kristoffer.mansson@ki.se.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lasselin', 'Affiliation': 'Stress Research Institute, Department of Psychology, Stockholm University, Stockholm, Sweden; Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Osher Center for Integrative Medicine, ME Neuroradiologi, Karolinska Universitetssjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Bianka', 'Initials': 'B', 'LastName': 'Karshikoff', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Stress Research Institute, Department of Psychology, Stockholm University, Stockholm, Sweden; Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Engler', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, Center for Translational Neuro- and Behavioral Sciences, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Institute of Medical Psychology and Behavioral Immunobiology, Center for Translational Neuro- and Behavioral Sciences, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, Center for Translational Neuro- and Behavioral Sciences, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Petrovic', 'Affiliation': 'Center for Cognitive and Computational Neuropsychiatry, Karolinska Institutet, Stockholm, Sweden; Neuro Division, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Stress Research Institute, Department of Psychology, Stockholm University, Stockholm, Sweden; Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Osher Center for Integrative Medicine, ME Neuroradiologi, Karolinska Universitetssjukhuset, Stockholm, Sweden.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2021.09.007']
1591,34541685,"Synergistic antimicrobial effect of photodynamic therapy and chitosan on the titanium-adherent biofilms of Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa: An in vitro study.","BACKGROUND


To date, no studies on the combined use of photodynamic therapy (PDT) and chitosan against peri-implantitis have been published. The aim of this study was to evaluate the possible synergistic antimicrobial effect of PDT and chitosan on the titanium-adherent biofilms of Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa.
METHODS


A total of 60 titanium discs were included in this study. The discs were randomized into three bacterial contaminations (n = 20 discs per bacterium). After being cultured (incubated for 48 hours) they were randomized again into four different disinfection modalities (n = 5 discs per treatment): control (without treatment), PDT, chitosan 3 mg/mL, and PDT + chitosan 3 mg/mL. After the treatments, the colony forming units (CFU) were measured to determine antimicrobial effects, and field emission scanning electron microscopy (FESEM) was used to study cell morphology and titanium adherence.
RESULTS


For all the evaluated bacteria and all the variables studied the order from highest to lowest antimicrobial effectiveness was: PDT + chitosan 3 mg/mL > chitosan 3 mg/mL > PDT > control. Although, all disinfection methods were significantly effective when compared to control, the combined treatment of PDT + chitosan 3 mg/mL had the greatest antimicrobial effect against the three studied bacteria.
CONCLUSIONS


The combination of PDT and chitosan has a synergistic antimicrobial effect against the bacteria S. aureus, E. coli, and P. aeruginosa, all closely related to peri-implantitis. However, further in vivo studies are needed because this study provides data based on an in vitro scenario that might not be extrapolated to patients with peri-implantitis.",2021,"The combination of PDT and chitosan has a synergistic antimicrobial effect against the bacteria S. aureus, E. coli and P. aeruginosa, all closely related to peri-implantitis.","['A total of 60 titanium discs', 'patients with peri-implantitis']","['PDT and chitosan', 'photodynamic therapy (PDT', 'photodynamic therapy and chitosan', 'PDT, chitosan 3 mg/ml, and PDT + chitosan 3 mg/ml']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]",[],,0.0671106,"The combination of PDT and chitosan has a synergistic antimicrobial effect against the bacteria S. aureus, E. coli and P. aeruginosa, all closely related to peri-implantitis.","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Camacho-Alonso', 'Affiliation': 'Department of Oral Surgery, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Salinas', 'Affiliation': 'Department of Animal Health, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sánchez-Siles', 'Affiliation': 'Private dental practice, Murcia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Pato-Mourelo', 'Affiliation': 'Private dental practice, Galicia, Spain.'}, {'ForeName': 'Brian Davis', 'Initials': 'BD', 'LastName': 'Cotrina-Veizaga', 'Affiliation': 'Private dental practice, Murcia, Spain.'}, {'ForeName': 'Nieves', 'Initials': 'N', 'LastName': 'Ortega', 'Affiliation': 'Department of Animal Health, University of Murcia, Murcia, Spain.'}]",Journal of periodontology,['10.1002/JPER.21-0306']
1592,34538851,Benefit of Higher Maximum Force Output in Bone Anchored Hearing Systems: A Crossover Study.,"OBJECTIVE


To investigate how higher maximum force output (MFO) in bone anchored hearing systems (BAHS) affects perceived benefit and the subjective experience of sound as well as hearing outcomes in subjects with mixed hearing loss.
STUDY DESIGN


Prospective single-center, randomized crossover design (A-B-A) with within-subject control design.
PATIENTS


The study included 19 experienced BAHS users with mixed hearing loss in the fitting range of a standard BAHS.
INTERVENTIONS


The study evaluated two sound processors with differing MFOs and sizes-Device A: standard sound processor with a lower MFO and Device B: superpower sound processor with a higher MFO.
OUTCOME MEASURES


Speech recognition in noise at different signal to noise ratios, aided thresholds, and questionnaires.
RESULTS


Speech recognition test showed significant improvements using Device B compared with Device A at both 78 dB SPL (mean difference: 9%) and 75 dB SPL (mean difference: 12%) (p < 0.05). Moreover, speech, spatial and qualities of hearing scale (SSQ12-C) showed a significantly greater perceived benefit with Device B concerning spatial abilities (mean: 0.5-0.6) (p < 0.05). At the conclusion of the study, 58% of participants chose to keep Device A for further use. The main reasons for this were the size of the sound processor and a more comfortable sound experience.
CONCLUSIONS


A BAHS sound processor with a higher MFO leads to improved speech-in-noise performance in loud/noisy listening situations and is perceived as significantly better to process spatial information in daily listening situations. However, the relation between cosmetics and performance is not straightforward, and several factors seem to affect the selection process of BAHS.",2021,"Moreover, speech, spatial and qualities of hearing scale (SSQ12-C) showed a significantly greater perceived benefit with Device B concerning spatial abilities (mean: 0.5-0.6) (p < 0.05).","['19 experienced BAHS users with mixed hearing loss in the fitting range of a standard BAHS', 'Bone Anchored Hearing Systems', 'subjects with mixed hearing loss']",['MFOs and sizes-Device A: standard sound processor with a lower MFO and Device B: superpower sound processor with a higher MFO'],"['Speech recognition in noise at different signal to noise ratios, aided thresholds, and questionnaires', 'benefit with Device B concerning spatial abilities', 'speech, spatial and qualities of hearing scale (SSQ12-C']","[{'cui': 'C1720978', 'cui_str': 'Bone Anchors'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0155552', 'cui_str': 'Mixed conductive AND sensorineural hearing loss'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0679024', 'cui_str': 'Spatial Ability'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",19.0,0.0651809,"Moreover, speech, spatial and qualities of hearing scale (SSQ12-C) showed a significantly greater perceived benefit with Device B concerning spatial abilities (mean: 0.5-0.6) (p < 0.05).","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Bergius', 'Affiliation': 'Region Västra Götaland, Habilitation & Health, Hearing Organization, Gothenburg, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Philipsson', 'Affiliation': 'Oticon Medical AB, Askim, Sweden.'}, {'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Rosenbom', 'Affiliation': 'Oticon Medical AB, Askim, Sweden.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Region Västra Götaland, Habilitation & Health, Hearing Organization, Gothenburg, Sweden.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000003331']
1593,34537951,Clinical Efficacy of Conservative Treatment with Micronized Purified Flavonoid Fraction in Female Patients with Pelvic Congestion Syndrome.,"INTRODUCTION


Pelvic congestion syndrome (PCS) may be effectively managed with conservative treatment in certain patients. Treatment with venoactive drugs is common, but supportive data are limited. This study evaluated the clinical efficacy of micronized purified flavonoid fraction (MPFF) in women with PCS.
METHODS


In a single-blind, placebo-controlled study, women with duplex ultrasound diagnosis of pelvic varicose veins (PVV) and PCS were randomized to MPFF 1000 mg once daily or placebo for 2 months. Clinical manifestations of PCS were evaluated at baseline and end of treatment (M2) using three assessment tools: disease-specific quality of life (QoL) Pelvic Varicose Vein Questionnaire (PVVQ), Pelvic Venous Clinical Severity Score (PVCSS), and the Visual Analog Scale (VAS) for the main symptoms of the disease.
RESULTS


A total of 83 women were included, 42 received MPFF and 41 received placebo. In the MPFF group, the mean global PVVQ QoL index decreased significantly from 45.1 ± 14.7 at baseline to 36.6 ± 10.6 at M2 (mean change: 8.2 ± 10.4); no significant change was observed in the control group (mean change: - 0.3 ± 4.0). The between-group difference was statistically significant (P < 0.001). Compared with control, significant improvements were observed in all four QoL parameters (pain, physical, social, psychological, all P < 0.001). The mean PVCSS summary score decreased significantly by 3.4 ± 3.4 in the MPFF group (P < 0.001) compared with a non-significant change of - 0.2 ± 1.6 in the control group (between-group difference P < 0.001). In the MPFF group, improvements were statistically significant for 6 out of 10 clinical manifestations of PCS measured using the PVCSS, including pain (mean change from baseline: 0.5 ± 0.7) heaviness (0.4 ± 0.7), discomfort (0.6 ± 0.7) and tenderness (0.3 ± 0.5). No significant improvements were observed in the control group. When measured by VAS, between-group differences were statistically significant for the overall summary score (P < 0.001) and for 8 out of 10 PCS symptoms, including: pain (mean MPFF change from baseline: 2.0 ± 2.2), heaviness (1.3 ± 2.1), discomfort (1.5 ± 2.0), tenderness (0.9 ± 1.9), and edema (1.3 ± 2.1).
CONCLUSION


In women with PCS, conservative treatment with MPFF was associated with improved QoL and reduced symptom severity. MPFF may be considered an effective and safe treatment option for PCS in routine clinical practice.",2021,"Compared with control, significant improvements were observed in all four QoL parameters (pain, physical, social, psychological, all P < 0.001).","['women with duplex ultrasound diagnosis of pelvic varicose veins (PVV) and PCS', 'A total of 83 women were included, 42 received MPFF and 41 received', 'women with PCS', 'Female Patients with Pelvic Congestion Syndrome']","['MPFF 1000\xa0mg once daily or placebo', 'MPFF', 'Micronized Purified Flavonoid Fraction', 'placebo', 'micronized purified flavonoid fraction (MPFF']","['pain', 'improved QoL and reduced symptom severity', 'heaviness', 'QoL parameters (pain, physical, social, psychological', 'mean PVCSS summary score', 'disease-specific quality of life (QoL) Pelvic Varicose Vein Questionnaire (PVVQ), Pelvic Venous Clinical Severity Score (PVCSS), and the Visual Analog Scale (VAS', 'mean global PVVQ QoL index', 'discomfort', 'overall summary score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242845', 'cui_str': 'Duplex ultrasound'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0155795', 'cui_str': 'Pelvic varices'}, {'cui': 'C0152078', 'cui_str': 'Pelvic congestion syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0155795', 'cui_str': 'Pelvic varices'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",83.0,0.0701673,"Compared with control, significant improvements were observed in all four QoL parameters (pain, physical, social, psychological, all P < 0.001).","[{'ForeName': 'Rustem V', 'Initials': 'RV', 'LastName': 'Akhmetzianov', 'Affiliation': 'Interregional Clinical Diagnostic Center, Department of Vascular Surgery, Kazan, Russia. arustemv@mail.ru.'}, {'ForeName': 'Roman A', 'Initials': 'RA', 'LastName': 'Bredikhin', 'Affiliation': 'Interregional Clinical Diagnostic Center, Department of Vascular Surgery, Kazan, Russia.'}]",Pain and therapy,['10.1007/s40122-021-00312-6']
1594,34537876,Carbohydrate hastens hypervolemia achieved through ingestion of aqueous sodium solution in resting euhydrated humans.,"PURPOSE


Ingesting beverages containing a high concentration of sodium under euhydrated conditions induces hypervolemia. Because carbohydrate can enhance interstitial fluid absorption via the sodium-glucose cotransporter and insulin-dependent renal sodium reabsorption, adding carbohydrate to high-sodium beverages may augment the hypervolemic response.
METHODS


To test this hypothesis, we had nine healthy young males ingest 1087 ± 82 mL (16-17 mL per kg body weight) of water or aqueous solution containing 0.7% NaCl, 0.7% NaCl + 6% dextrin, 0.9% NaCl, or 0.9% NaCl + 6% dextrin under euhydrated conditions. Each drink was divided into six equal volumes and ingested at 10-min intervals. During each trial, participants remained resting for 150 min. Measurements were made at baseline and every 30 min thereafter.
RESULTS


Plasma osmolality decreased with water ingestion (P ≤ 0.023), which increased urine volume such that there was no elevation in plasma volume from baseline (P ≥ 0.059). The reduction in plasma osmolality did not occur with ingestion of solution containing 0.7% or 0.9% NaCl (P ≥ 0.051). Consequently, urine volume was 176-288 mL smaller than after water ingestion and resulted in plasma volume expansion at 60 min and later times (P ≤ 0.042). In addition, net fluid balance was 211-329 mL greater than after water ingestion (P ≤ 0.028). Adding 6% dextrin to 0.7% or 0.9% NaCl solution resulted in plasma volume expansion within as little as 30 min (P ≤ 0.026), though the magnitudes of the increases in plasma volume were unaffected (P ≥ 0.148).
CONCLUSION


Dextrin mediates an earlier hypervolemic response associated with ingestion of high-sodium solution in resting euhydrated young men. (247/250 words).",2021,"In addition, net fluid balance was 211-329 mL greater than after water ingestion (P ≤ 0.028).","['resting euhydrated humans', 'resting euhydrated young men', 'nine healthy young males ingest 1087\u2009±\u200982\xa0mL (16-17\xa0mL per kg body weight) of']","['water or aqueous solution containing 0.7% NaCl, 0.7% NaCl\u2009+\u20096% dextrin, 0.9% NaCl, or 0.9% NaCl\u2009+\u20096% dextrin under euhydrated conditions']","['plasma volume expansion', 'plasma osmolality', 'net fluid balance', 'plasma volume', 'urine volume', 'Plasma osmolality']","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0011808', 'cui_str': 'Dextrins'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}]",9.0,0.0512312,"In addition, net fluid balance was 211-329 mL greater than after water ingestion (P ≤ 0.028).","[{'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Ibaraki, 305-8574, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sugihara', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Ibaraki, 305-8574, Japan.'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Ibaraki, 305-8574, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Niwa', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Ibaraki, 305-8574, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Katagiri', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Ibaraki, 305-8574, Japan.'}, {'ForeName': 'Shodai', 'Initials': 'S', 'LastName': 'Moriyama', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Ibaraki, 305-8574, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Miyanagi', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Ibaraki, 305-8574, Japan.'}, {'ForeName': 'Jumpei', 'Initials': 'J', 'LastName': 'Kojima', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Ibaraki, 305-8574, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nishiyasu', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Ibaraki, 305-8574, Japan. nishiyasu.takeshi.fw@u.tsukuba.ac.jp.'}]",European journal of applied physiology,['10.1007/s00421-021-04788-0']
1595,34518157,Lower extremity MRI following 10-week supervised exercise intervention in patients with diabetic peripheral neuropathy.,"INTRODUCTION


The purpose of this study was to characterize using MRI the effects of a 10-week supervised exercise program on lower extremity skeletal muscle composition, nerve microarchitecture, and metabolic function in individuals with diabetic peripheral neuropathy (DPN).
RESEARCH DESIGN AND METHODS


Twenty participants with DPN completed a longitudinal trial consisting of a 30-day control period, during which subjects made no change to their lifestyle, followed by a 10-week intervention program that included three supervised aerobic and resistance exercise sessions per week targeting the upper and lower extremities. The participants' midcalves were scanned with multinuclear MRI two times prior to intervention (baseline 1  and baseline 2 ) and once following intervention to measure relaxation times (T1, T1ρ, and T2), phosphocreatine recovery, fat fraction, and diffusion parameters.
RESULTS


There were no changes between baseline 1  and baseline 2  MRI metrics (p>0.2). Significant changes (p<0.05) between baseline 2  and postintervention MRI metrics were: gastrocnemius medialis (GM) T1 -2.3%±3.0% and soleus T2 -3.2%±3.1%. Trends toward significant changes (0.05<p<0.1) between baseline 2  and postintervention MRI metrics were: calf adipose infiltration -2.6%±6.4%, GM T1ρ -4.1%±7.7%, GM T2 -3.5%±6.4%, and gastrocnemius lateral T2 -4.6±7.4%. Insignificant changes were observed in gastrocnemius phosphocreatine recovery rate constant (p>0.3) and tibial nerve fractional anisotropy (p>0.6) and apparent diffusion coefficient (p>0.4).
CONCLUSIONS


The 10-week supervised exercise intervention program successfully reduced adiposity and altered resting tissue properties in the lower leg in DPN. Gastrocnemius mitochondrial oxidative capacity and tibial nerve microarchitecture changes were not observed, either due to lack of response to therapy or to lack of measurement sensitivity.",2021,Significant changes (p<0.05) between baseline 2  and postintervention MRI metrics were: gastrocnemius medialis (GM) T1 -2.3%±3.0% and soleus T2 -3.2%±3.1%.,"['patients with diabetic peripheral neuropathy', 'Twenty participants with DPN completed a longitudinal trial consisting of a 30-day control period, during which subjects made no change to their lifestyle, followed by a 10-week intervention program that included three', 'individuals with diabetic peripheral neuropathy (DPN']","['supervised exercise intervention program', 'supervised exercise program', 'supervised aerobic and resistance exercise sessions', 'supervised exercise intervention']","['gastrocnemius phosphocreatine recovery rate constant (p>0.3) and tibial nerve fractional anisotropy (p>0.6) and apparent diffusion coefficient (p>0.4', 'lower extremity skeletal muscle composition, nerve microarchitecture, and metabolic function', 'Gastrocnemius mitochondrial oxidative capacity and tibial nerve microarchitecture changes', 'Lower extremity MRI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205449', 'cui_str': '3'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0031634', 'cui_str': 'fosfocreatine'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",20.0,0.0418049,Significant changes (p<0.05) between baseline 2  and postintervention MRI metrics were: gastrocnemius medialis (GM) T1 -2.3%±3.0% and soleus T2 -3.2%±3.1%.,"[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Department of Radiology, New York University Grossman School of Medicine, New York City, New York, USA Ryan.Brown@nyulangone.org.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Sharafi', 'Affiliation': 'Department of Radiology, New York University Grossman School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Slade', 'Affiliation': 'Department of Radiology, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Convit', 'Affiliation': 'Department of Psychiatry, New York University Grossman School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Davis', 'Affiliation': 'Department of Osteopathic Medicine, New York Institute of Technology, Old Westbury, New York, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Baete', 'Affiliation': 'Department of Radiology, New York University Grossman School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Milton', 'Affiliation': 'Sports Performance Center, New York University Langone Health, New York City, New York, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mroczek', 'Affiliation': 'Department of Orthopedic Surgery, New York University Grossman School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kluding', 'Affiliation': 'Department of Physical Therapy, Rehabilitation Science, and Athletic Training, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Ravinder R', 'Initials': 'RR', 'LastName': 'Regatte', 'Affiliation': 'Department of Radiology, New York University Grossman School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Prodromos', 'Initials': 'P', 'LastName': 'Parasoglou', 'Affiliation': 'Department of Radiology, New York University Grossman School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Physical Therapy, New York University, New York City, New York, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2021-002312']
1596,34521624,Evaluating Serum Thymidine Kinase 1 in Patients with Hormone Receptor-Positive Metastatic Breast Cancer Receiving First-line Endocrine Therapy in the SWOG S0226 Trial.,"PURPOSE


Serum thymidine kinase 1 (sTK1) activity is associated with poor prognosis in metastatic breast cancer (MBC). We assessed the prognostic effect of sTK1 in patients with hormone receptor-positive MBC treated on a prospective randomized trial of anastrozole (A) versus A plus fulvestrant (A + F).
EXPERIMENTAL DESIGN


sTK1 was assessed in 1,726 serums [baseline (BL), cycles 2, 3, 4, and 7] using the DiviTum assay. A prespecified cutoff of ≥200 Du/L was considered high. Progression-free survival (PFS) and overall survival (OS) were analyzed by Kaplan-Meier, log-rank tests, and Cox regression.
RESULTS


BL sTK1 was elevated in 171 (40%) of 432 patients. Patients with high versus low BL sTK1 had significantly worse PFS [median 11.2 vs. 17.3 months, HR = 1.76; 95% confidence interval (CI; 1.43-2.16);  P  < 0.0001] and OS [median 30 vs. 58 months, HR = 2.38; 95% CI (1.91-2.98);  P  < 0.0001]. OS was significantly better for patients with high sTK1 who did not have prior adjuvant tamoxifen and who received A + F versus A alone [median 46 vs. 21 months, HR = 0.58; 95% CI (0.38-0.87);  P  = 0.0087]. Patients with low sTK1 had no difference in outcomes by therapy ( P  = 0.44). At serial timepoints, high versus low sTK1 had significantly worse subsequent PFS and OS [at cycle 2: PFS HR = 1.70, 95% CI (1.34-2.17);  P  < 0.0001, OS HR = 2.51, 95% CI (1.93-3.26);  P  < 0.0001].
CONCLUSIONS


High sTK1 at BL and subsequent timepoints is associated with worse prognosis in patients with MBC starting first-line endocrine therapy (ET). Patients with low sTK1 at BL have comparable outcomes on single-agent or combination ET.",2021,"sTK1 had significantly worse PFS [median 11.2 versus 17.3 months, hazard ratio (HR)= 1.76; 95% CI (1.43-2.16); p<0.0001] and OS (median 30 versus 58 months, HR=2.38; 95% CI (1.91-2.98); p<0.0001).","['sTK1 was assessed in 1,726 serums [baseline (BL), cycles 2, 3, 4, and 7] using the DiviTum® assay', 'Hormone Receptor Positive Metastatic Breast Cancer Patients Receiving First Line Endocrine Therapy in the SWOG S0226 Trial', 'metastatic breast cancer (MBC', 'Patients with high vs. low', 'patients with hormone receptor-positive MBC']","['anastrozole (A) vs. A plus fulvestrant (A+F', 'tamoxifen', 'sTK1', 'BL']","['Progression-free survival (PFS) and overall survival (OS', 'subsequent PFS and OS', 'PFS', 'OS', 'BL sTK1']","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0295748', 'cui_str': 'thymidine kinase 1'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0295748', 'cui_str': 'thymidine kinase 1'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0295748', 'cui_str': 'thymidine kinase 1'}]",1726.0,0.100264,"sTK1 had significantly worse PFS [median 11.2 versus 17.3 months, hazard ratio (HR)= 1.76; 95% CI (1.43-2.16); p<0.0001] and OS (median 30 versus 58 months, HR=2.38; 95% CI (1.91-2.98); p<0.0001).","[{'ForeName': 'Costanza', 'Initials': 'C', 'LastName': 'Paoletti', 'Affiliation': 'University of Michigan Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'SWOG Statistical Center, Seattle, Washington.'}, {'ForeName': 'Erin F', 'Initials': 'EF', 'LastName': 'Cobain', 'Affiliation': 'University of Michigan Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Bergqvist', 'Affiliation': 'Biovica International, Uppsala, Sweden.'}, {'ForeName': 'Rita S', 'Initials': 'RS', 'LastName': 'Mehta', 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange, California.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'Seattle Cancer Care Alliance and University of Washington Medical Center, Seattle, Washington.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, Illinois.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': 'Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Godwin', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Dan L Duncan Cancer Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'University of Michigan Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Rae', 'Affiliation': 'University of Michigan Rogel Cancer Center, Ann Arbor, Michigan. jimmyrae@umich.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-1562']
1597,34521615,Improving the Follow-up Rate for Pediatric Patients (0-16 years) of an Eye Hospital in Nepal: Protocol for a Public Health Intervention Study.,"BACKGROUND


The follow-up of pediatric patients ensures regular ocular morbidity monitoring and better treatment outcome. Hiralal Santudevi Pradhan Institute of Ophthalmic Science (Bharatpur Eye Hospital [BEH]) noticed that the follow-up rate was only 22% among its pediatric patients. Several factors like lack of awareness and forgetfulness among patients may contribute to a lower number of follow-up visits. Therefore, BEH decided to find if counseling and reminders through SMS text messaging and phone calls would improve the follow-up rates.
OBJECTIVE


This study aims to evaluate the impact of interventions like counseling and reminder SMS text messaging and phone calls in improving the follow-up rate of pediatric patients.
METHODS


This is a public health intervention study being conducted using quantitative analysis. All children (0-16 years) with ocular conditions requiring at least 3 follow-up visits in the study period will be included. In all, 264 participants will be allocated to 3 groups: routine standard care, counseling, and reminders with SMS text messaging and phone calls. In counseling, patients will take part in 20-minute counseling sessions with trained counselors at each visit, and information leaflets will be provided to them. In the reminder SMS text messaging and phone call group, patients will receive an SMS text message 3 days prior and a phone call 1 day prior to their scheduled visits. Patients attending within 2 days of the scheduled date will be considered compliant to follow-up. The proportion of patients completing all the follow-up visits in each group will be assessed. Informed consent will be taken from parents and children. Univariate and multivariate analyses will be conducted.
RESULTS


The ethical approval for this study has been obtained from the Ethical Review Board (ERB) of Nepal Health Research Council (ERB protocol registration #761/2020 P). The data collection was initiated on January, 24, 2021, but due to the COVID-19 pandemic, as of September 2021, we have only been able to enroll 154 of the planned 264 participants (58.3% of the sample size).
CONCLUSIONS


This study will reliably document not only the factors associated with follow-up rate through an intervention package (counseling and reminders through SMS text messaging and phone calls) but also the cost effectiveness of the intervention package, which can be applied in all the departments of the hospital.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04837534; https://clinicaltrials.gov/ct2/show/NCT04837534.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/31578.",2021,"Two hundred and sixty four participants will be allocated to three groups: routine standard care, counseling and reminders with SMS and phone calls.","['pediatric patients', 'Two hundred and sixty four participants will be allocated to three groups', 'All children (0-16 years) with ocular conditions requiring at least 3 follow ups in the study period will be included', '154 participants (58% of the sample size', 'pediatric patients (0-16 years) attending Bharatpur Eye Hospital, Bharatpur, Chitwan, Nepal']","['Ophthalmic Science', 'routine standard care, counseling and reminders with SMS and phone calls', 'interventions like counselling and reminder SMS and phone call']","['Bharatpur Eye Hospital (BEH', 'regular ocular morbidity monitoring']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",264.0,0.0917673,"Two hundred and sixty four participants will be allocated to three groups: routine standard care, counseling and reminders with SMS and phone calls.","[{'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Shrestha', 'Affiliation': 'Bharatpur Eye Hospital, Chitwan, Nepal.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Bhandari', 'Affiliation': 'Bharatpur Eye Hospital, Chitwan, Nepal.'}, {'ForeName': 'Suresh Kumar', 'Initials': 'SK', 'LastName': 'Rathi', 'Affiliation': 'Indian Institute of Public Health, Hyderabad, India.'}, {'ForeName': 'Anirudh Gaurang', 'Initials': 'AG', 'LastName': 'Gudlavalleti', 'Affiliation': 'Indian Institute of Public Health, Hyderabad, India.'}, {'ForeName': 'Binod', 'Initials': 'B', 'LastName': 'Pandey', 'Affiliation': 'Bharatpur Eye Hospital, Chitwan, Nepal.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Ghimire', 'Affiliation': 'Bharatpur Eye Hospital, Chitwan, Nepal.'}, {'ForeName': 'Daman', 'Initials': 'D', 'LastName': 'Ale', 'Affiliation': 'Bharatpur Eye Hospital, Chitwan, Nepal.'}, {'ForeName': 'Sajani', 'Initials': 'S', 'LastName': 'Kayastha', 'Affiliation': 'Bharatpur Eye Hospital, Chitwan, Nepal.'}, {'ForeName': 'Daya Shankar', 'Initials': 'DS', 'LastName': 'Chaudhary', 'Affiliation': 'Bharatpur Eye Hospital, Chitwan, Nepal.'}, {'ForeName': 'Raghunandan', 'Initials': 'R', 'LastName': 'Byanju', 'Affiliation': 'Bharatpur Eye Hospital, Chitwan, Nepal.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""See Authors' Contributions, .""}]",JMIR research protocols,['10.2196/31578']
1598,34520250,"A Randomized, Double-Blind, Controlled Trial of Lithium Versus Quetiapine for the Treatment of Acute Mania in Youth with Early Course Bipolar Disorder.","Objective:  To compare the efficacy and tolerability of lithium versus quetiapine for the treatment of manic or mixed episodes in youths with early course bipolar I disorder.  Methods:  Six-week, randomized, double-blind clinical trial of lithium versus quetiapine for the treatment of adolescents with acute manic/mixed episode. Target dose of quetiapine dose was adjusted to a target dose of 400-600 mg and target serum level for lithium was 1.0-1.2 mEq/L. Primary outcome measure was baseline-to-endpoint change in the Young Mania Rating Scale (YMRS). Secondary outcomes were treatment response (50% or more decrease from baseline in YMRS score) and remission (YMRS score ≤12, Children's Depression Rating Scale-Revised [CDRS-R] total score ≤28 and Clinical Global Impression Bipolar Severity Scale [CGI-BP-S] overall score of ≤3, respectively).  Results:  A total of 109 patients were randomized (quetiapine = 58 and lithium = 51). Participants in the quetiapine treatment group showed a significantly greater reduction in YMRS score than those in the lithium group (-11.0 vs. -13.2;  p  < 0.001; effect size 0.39). Response rate was 72% in the quetiapine group and 49% in the lithium group ( p  = 0.012); no differences in remission rates between groups were observed. Most frequent side effects for lithium were headaches (60.8%), nausea (39.2%), somnolence (27.5%), and tremor (27.5%); for quetiapine somnolence (63.8%), headaches (55.2%), tremor (36.2%), and dizziness (36.2%) were evidenced. Participants receiving quetiapine experienced more somnolence ( p  < 0.001), dizziness ( p  < 0.05), and weight gain ( p  < 0.05).  Conclusions:  Treatment with both lithium and quetiapine led to clinical improvement. Most study participants in this study experienced a clinical response; however, less than half of the participants in this study achieved symptomatic remission. The head-to-head comparison of both treatment groups showed quetiapine was associated with a statistically significant greater rate of response and overall symptom reduction compared with lithium. Trial registration: clinicaltrials.gov NCT00893581.",2021,Participants in the quetiapine treatment group showed a significantly greater reduction in YMRS score than those in the lithium group (-11.0 vs. -13.2;  p  < 0.001; effect size 0.39).,"['youths with early course bipolar I disorder', 'Acute Mania in Youth with Early Course Bipolar Disorder', 'A total of 109 patients were randomized (quetiapine\u2009=\u200958 and lithium\u2009=\u200951', 'adolescents with acute manic/mixed episode']","['lithium and quetiapine', 'quetiapine', 'lithium versus quetiapine', 'Lithium Versus Quetiapine', 'lithium']","['YMRS score', 'Response rate', 'dizziness', 'weight gain', 'rate of response and overall symptom reduction', 'quetiapine somnolence', 'symptomatic remission', 'nausea', 'Young Mania Rating Scale (YMRS', 'somnolence', 'efficacy and tolerability', ""YMRS score) and remission (YMRS score ≤12, Children's Depression Rating Scale-Revised [CDRS-R] total score ≤28 and Clinical Global Impression Bipolar Severity Scale [CGI-BP-S] overall score of ≤3, respectively"", 'headaches', 'remission rates']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder'}, {'cui': 'C0235165', 'cui_str': 'Mania acute'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}]","[{'cui': 'C3640523', 'cui_str': 'YMRS'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",109.0,0.305495,Participants in the quetiapine treatment group showed a significantly greater reduction in YMRS score than those in the lithium group (-11.0 vs. -13.2;  p  < 0.001; effect size 0.39).,"[{'ForeName': 'Luis R', 'Initials': 'LR', 'LastName': 'Patino', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Blom', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Maxwell J', 'Initials': 'MJ', 'LastName': 'Tallman', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Caleb M', 'Initials': 'CM', 'LastName': 'Adler', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Welge', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'DelBello', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2021.0039']
1599,34520219,Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma.,"PURPOSE


To address the role of consolidation treatment for newly diagnosed, transplant eligible patients with multiple myeloma in a controlled clinical trial.
PATIENTS AND METHODS


The EMN02/HOVON95 trial compared consolidation treatment with two cycles of bortezomib, lenalidomide, and dexamethasone (VRD) or no consolidation after induction and intensification therapy, followed by continuous lenalidomide maintenance. Primary study end point was progression-free survival (PFS).
RESULTS


Eight hundred seventy-eight eligible patients were randomly assigned to receive VRD consolidation (451 patients) or no consolidation (427 patients). At a median follow-up of 74.8 months, median PFS with adjustment for pretreatment was prolonged in patients randomly assigned to VRD consolidation (59.3  v  42.9 months, hazard ratio [HR] = 0.81; 95% CI, 0.68 to 0.96;  P  = .016). The PFS benefit was observed across most predefined subgroups, including revised International Staging System (ISS) stage, cytogenetics, and prior treatment. Revised ISS3 stage (HR, 2.00; 95% CI, 1.41 to 2.86) and ampl1q (HR, 1.67; 95% CI, 1.37 to 2.04) were significant adverse prognostic factors. The median duration of maintenance was 33 months (interquartile range 13-86 months). Response ≥ complete response (CR) after consolidation versus no consolidation before start of maintenance was 34% versus 18%, respectively ( P  < .001). Response ≥ CR on protocol including maintenance was 59% with consolidation and 46% without ( P  < .001). Minimal residual disease analysis by flow cytometry in a subgroup of 226 patients with CR or stringent complete response or very good partial response before start of maintenance demonstrated a 74% minimal residual disease-negativity rate in VRD-treated patients. Toxicity from VRD was acceptable and manageable.
CONCLUSION


Consolidation treatment with VRD followed by lenalidomide maintenance improves PFS and depth of response in newly diagnosed patients with multiple myeloma as compared to maintenance alone.",2021,Response ≥ CR on protocol including maintenance was 59% with consolidation and 46% without ( P  < .001).,"['newly diagnosed, transplant eligible patients with multiple myeloma in a controlled clinical trial', 'Eight hundred seventy-eight eligible patients', 'Newly Diagnosed Multiple Myeloma', 'newly diagnosed patients with multiple myeloma']","['lenalidomide maintenance', 'bortezomib, lenalidomide, and dexamethasone (VRD', 'VRD consolidation (451 patients) or no consolidation']","['progression-free survival (PFS', 'Toxicity', 'PFS and depth of response', 'Response ≥ complete response (CR', 'residual disease-negativity rate', 'median duration of maintenance', 'median PFS']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",878.0,0.171403,Response ≥ CR on protocol including maintenance was 59% with consolidation and 46% without ( P  < .001).,"[{'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'Department of Hematology, HOVON Data Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aquino', 'Affiliation': 'IRCCS Azienda Ospedaliera Universitaria San Martino, IST Instituto Nazionale per la Ricerca sul Cancro, Genova, Italy.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Ludwig', 'Affiliation': 'Wilhelminen Cancer Research Institute, c/o Wilhelminenspital, Vienna, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Department of Hematology, Amsterdam UMC, Cancer Center Amsterdam, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Zander', 'Affiliation': 'Medical Oncology, Luzerner Kantonshospital, Luzern, Switzerland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zamagni', 'Affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia ""Seràgnoli"" and Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wester', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hajek', 'Affiliation': 'University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Pantani', 'Affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia ""Seràgnoli,"" Bologna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dozza', 'Affiliation': 'Department of Experimental, Diagnostic and Experimental Medicine, Seràgnoli Institute of Hematology, Bologna University School of Medicine, S. Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gay', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'AnneMaria', 'Initials': 'A', 'LastName': 'Cafro', 'Affiliation': 'ASST Grande Ospedale Metropolitano, Niguarda, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'De Rosa', 'Affiliation': 'Ospedale San Camillo Forlanini, Rome, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Morelli', 'Affiliation': 'Department of Hematology, Transfusion Medicine and Biotechnology Santo Spirito, Civic Hospital, Pescara, Italy.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Gregersen', 'Affiliation': 'Department of Haematology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gulbrandsen', 'Affiliation': 'Department of Hematology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Cornelisse', 'Affiliation': 'HOVON Data Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Rosella', 'Initials': 'R', 'LastName': 'Troia', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Oliva', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'van de Velden', 'Affiliation': 'Department of Immunology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'KaLung', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Paula F', 'Initials': 'PF', 'LastName': 'Ypma', 'Affiliation': 'Department of Hematology, Haga Ziekenhuis, The Hague, the Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bos', 'Affiliation': 'Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Driessen', 'Affiliation': 'Department of Oncology/Hematology, Kantonsspital, St Gallen, Switzerland.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Broijl', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Croockewit', 'Affiliation': 'Department of Hematology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Monique C', 'Initials': 'MC', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Waage', 'Affiliation': 'Department of Hematology, St Olav Hospital, Trondheim, Norway.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Hveding', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Department of Hematology, Amsterdam UMC, Cancer Center Amsterdam, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Offidani', 'Affiliation': 'Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy.'}, {'ForeName': 'Giuseppe A', 'Initials': 'GA', 'LastName': 'Palumbo', 'Affiliation': 'Department of Scienze Mediche Chirurgiche e Tecnologie Avanzate ""G.F. Ingrassia,"" University of Catania, Catania, Italy.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Department of Haematology, Alfred Hospital-Monash University, Melbourne, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'IRCCS S.Orsola-Malpighi, Istituto di Ematologia ""Seràgnoli,"" Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università degli Studi di Bologna, Bologna, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01045']
1600,34528132,Hypohydration produced by high-intensity intermittent running increases biomarkers of renal injury in males.,"PURPOSE


Whilst there is evidence to suggest that hypohydration caused by physical work in the heat increases renal injury, whether this is the case during exercise in temperate conditions remains unknown. This study investigated the effect of manipulating hydration status during high-intensity intermittent running on biomarkers of renal injury.
METHODS


After familiarisation, 14 males (age: 33 ± 7 years; V̇O 2peak : 57.1 ± 8.6 ml/kg/min; mean ± SD) completed 2 trials in a randomised cross-over design, each involving 6, 15 min blocks of shuttle running (modified Loughborough Intermittent Shuttle Test protocol) in temperate conditions (22.3 ± 1.0 °C; 47.9 ± 12.9% relative humidity). During exercise, subjects consumed either a volume of water equal to 90% of sweat losses (EU) or 75 mL water (HYP). Body mass, blood and urine samples were taken pre-exercise (baseline/pre), 30 min post-exercise (post) and 24 h post-baseline (24 h).
RESULTS


Post-exercise, body mass loss, serum osmolality and urine osmolality were greater in HYP than EU (P ≤ 0.024). Osmolality-corrected urinary kidney injury molecule-1 (uKIM-1) concentrations were increased post-exercise (P ≤ 0.048), with greater concentrations in HYP than EU (HYP: 2.76 [1.72-4.65] ng/mOsm; EU: 1.94 [1.1-2.54] ng/mOsm; P = 0.003; median [interquartile range]). Osmolality-corrected urinary neutrophil gelatinase-associated lipocalin (uNGAL) concentrations were increased post-exercise (P < 0.001), but there was no trial by time interaction effect (P = 0.073).
CONCLUSION


These results suggest that hypohydration produced by high-intensity intermittent running increases renal injury, compared to when euhydration is maintained, and that the site of this increased renal injury is at the proximal tubules.",2021,"Osmolality-corrected urinary kidney injury molecule-1 (uKIM-1) concentrations were increased post-exercise (P ≤ 0.048), with greater concentrations in HYP than EU (HYP: 2.76 [1.72-4.65] ng/mOsm; EU: 1.94 [1.1-2.54] ng/mOsm; P = 0.003; median [interquartile range]).","['14 males (age: 33\u2009±\u20097\xa0years; V̇O 2peak : 57.1\u2009±\u20098.6\xa0ml/kg/min; mean\u2009±\u2009SD', 'renal injury in males']","['pre-exercise (baseline/pre), 30\xa0min post-exercise (post) and 24\xa0h post-baseline (24\xa0h', 'volume of water equal to 90% of sweat losses (EU) or 75\xa0mL water (HYP', 'shuttle running (modified Loughborough Intermittent Shuttle Test protocol']","['Osmolality-corrected urinary kidney injury molecule-1 (uKIM-1) concentrations', 'Body mass, blood and urine samples', 'body mass loss, serum osmolality and urine osmolality', 'Osmolality-corrected urinary neutrophil gelatinase-associated lipocalin (uNGAL) concentrations']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0733682', 'cui_str': 'Hypophosphatemic Rickets, X-Linked Dominant'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0430518', 'cui_str': 'Shuttle test'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0202151', 'cui_str': 'Osmolality measurement, serum'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}]",,0.0410102,"Osmolality-corrected urinary kidney injury molecule-1 (uKIM-1) concentrations were increased post-exercise (P ≤ 0.048), with greater concentrations in HYP than EU (HYP: 2.76 [1.72-4.65] ng/mOsm; EU: 1.94 [1.1-2.54] ng/mOsm; P = 0.003; median [interquartile range]).","[{'ForeName': 'Loris A', 'Initials': 'LA', 'LastName': 'Juett', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Katharine L', 'Initials': 'KL', 'LastName': 'Midwood', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Funnell', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Mears', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK. S.A.Mears@lboro.ac.uk.'}]",European journal of applied physiology,['10.1007/s00421-021-04804-3']
1601,34547521,Romosozumab reduces incidence of new vertebral fractures across severity grades among postmenopausal women with osteoporosis.,"Vertebral fractures (VFs) are the most common type of osteoporotic fracture, and their prevalence and severity are key risk factors for future fragility fractures. Here, we assess the treatment effect of romosozumab on the incidence of new on-study VFs according to Genant severity grades (mild, moderate, and severe). Data are reported from two phase 3 clinical studies for patients who received romosozumab versus placebo through 12 months, followed by denosumab through 24 months (FRAME: NCT01575834), and for patients who received romosozumab through 12 months, followed by alendronate through 24 months, versus alendronate only through 24 months (ARCH: NCT01631214). The treatment effect of romosozumab is reported for all included patients, and for patients with prevalent and severe baseline VFs. The incidence of new moderate-or-severe VFs was reduced through 12 months for patients treated with romosozumab versus placebo (FRAME; 0.25% versus 1.42%, respectively; p < 0.001) or alendronate (ARCH; 2.78% versus 4.00%, respectively; p = 0.042). Furthermore, the treatment effect of romosozumab on the incidence of new VFs across moderate and severe severity grades was independent of baseline VF prevalence or severity; through 12 months, consistent reductions in new moderate-or-severe VFs were observed regardless of prevalent (FRAME; p = 0.18) or severe (ARCH; p = 0.52) VFs at baseline. Reductions in the incidence of new moderate and severe VFs were sustained through 24 months, after transition from romosozumab to denosumab or alendronate, independent of baseline VF prevalence or severity; no significant interactions were observed between the incidence of new moderate-or-severe VFs and the presence of prevalent (FRAME; p = 0.81) or severe (ARCH; p = 0.99) VFs at baseline. With increasing recommendations for initial treatment with bone-forming agents for postmenopausal women with osteoporosis, these analyses will help to inform treatment decisions for patients at very high risk of VF.",2021,"The incidence of new moderate-or-severe VFs was reduced through 12 months for patients treated with romosozumab versus placebo (FRAME; 0.25% versus 1.42%, respectively; p<0.001) or alendronate (ARCH; 2.78% versus 4.00%, respectively; p=0.042).","['postmenopausal women with osteoporosis', 'Postmenopausal Women with Osteoporosis', 'patients with prevalent and severe baseline VFs']","['alendronate', 'romosozumab versus placebo', 'romosozumab', 'Romosozumab']","['new moderate-or-severe VFs', 'incidence of new moderate-or-severe VFs', 'incidence of new moderate and severe VFs']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.080917,"The incidence of new moderate-or-severe VFs was reduced through 12 months for patients treated with romosozumab versus placebo (FRAME; 0.25% versus 1.42%, respectively; p<0.001) or alendronate (ARCH; 2.78% versus 4.00%, respectively; p=0.042).","[{'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Geusens', 'Affiliation': 'Maastricht University Medical Center, Maastricht, the Netherlands; University Hasselt, Belgium. Electronic address: drpgeusens@gmail.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Senior Clinical Trials, Inc, Laguna Hills, CA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Oates', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': 'Hopital Nord, CHU Saint-Etienne, Saint-Etienne and INSERM 1059, Universite de Lyon, Saint-Etienne, France.'}, {'ForeName': 'Polyzois', 'Initials': 'P', 'LastName': 'Makras', 'Affiliation': '251 Hellenic Air Force & VA-General Hospital, Athens, Greece.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Jakob', 'Affiliation': 'University of Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Zhenxun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rojeski', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}]",Bone,['10.1016/j.bone.2021.116209']
1602,34528335,Relationship between primary stroke center volume and time to endovascular thrombectomy in acute ischemic stroke.,"BACKGROUND AND PURPOSE


We investigated whether the annual volume of patients with acute ischemic stroke referred from a primary stroke center (PSC) for endovascular treatment (EVT) is associated with treatment times and functional outcome.
METHODS


We used data from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) registry (2014-2017). We included patients with acute ischemic stroke of the anterior circulation who were transferred from a PSC to a comprehensive stroke center (CSC) for EVT. We examined the association between EVT referral volume of PSCs and treatment times and functional outcome using multivariable regression modeling. The main outcomes were time from arrival at the PSC to groin puncture (PSC-door-to-groin time), adjusted for estimated ambulance travel times, time from arrival at the CSC to groin puncture (CSC-door-to-groin time), and modified Rankin Scale (mRS) score at 90 days after stroke.
RESULTS


Of the 3637 patients in the registry, 1541 patients (42%) from 65 PSCs were included. Mean age was 71 years (SD ± 13.3), median National Institutes of Health Stroke Scale score was 16 (interquartile range [IQR]: 12-19), and median time from stroke onset to arrival at the PSC was 53 min (IQR: 38-90). Eighty-three percent had received intravenous thrombolysis. EVT referral volume was not associated with PSC-door-to-groin time (adjusted coefficient: -0.49 min/annual referral, 95% confidence interval [CI]: -1.27 to 0.29), CSC-door-to-groin time (adjusted coefficient: -0.34 min/annual referral, 95% CI: -0.69 to 0.01) or 90-day mRS score (adjusted common odds ratio: 0.99, 95% CI: 0.96-1.01).
CONCLUSIONS


In patients transferred from a PSC for EVT, higher PSC volumes do not seem to translate into better workflow metrics or patient outcome.",2021,"EVT referral volume was not associated with PSC-door-to-groin time (adjusted coefficient: -0.49 min/annual referral, 95% confidence interval [CI]: -1.27 to 0.29), CSC-door-to-groin time (adjusted coefficient: -0.34 min/annual referral, 95% CI: -0.69 to 0.01) or 90-day mRS score (adjusted common odds ratio: 0.99, 95% CI: 0.96-1.01).
","['Acute Ischemic Stroke in the Netherlands (MR CLEAN) registry (2014-2017', 'patients with acute ischemic stroke of the anterior circulation who were transferred from a PSC to a comprehensive stroke center (CSC) for EVT', 'patients with acute ischemic stroke referred from a primary stroke center (PSC) for endovascular treatment (EVT', '3637 patients in the registry, 1541 patients (42%) from 65 PSCs were included', 'acute ischemic stroke', 'Mean age was 71\xa0years (SD\xa0±\xa013.3), median National Institutes of Health Stroke Scale score was 16 (interquartile range [IQR]: 12-19), and median time from stroke onset to arrival at the PSC was 53\xa0min (IQR: 38-90']","['intravenous thrombolysis', 'Endovascular Treatment']","['EVT referral volume', '90-day mRS score', 'time from arrival at the PSC to groin puncture (PSC-door-to-groin time), adjusted for estimated ambulance travel times, time from arrival at the CSC to groin puncture (CSC-door-to-groin time), and modified Rankin Scale (mRS) score', 'PSC-door-to-groin time', 'CSC-door-to-groin time']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0040802', 'cui_str': 'Travel'}]",3637.0,0.182777,"EVT referral volume was not associated with PSC-door-to-groin time (adjusted coefficient: -0.49 min/annual referral, 95% confidence interval [CI]: -1.27 to 0.29), CSC-door-to-groin time (adjusted coefficient: -0.34 min/annual referral, 95% CI: -0.69 to 0.01) or 90-day mRS score (adjusted common odds ratio: 0.99, 95% CI: 0.96-1.01).
","[{'ForeName': 'Laura C C', 'Initials': 'LCC', 'LastName': 'van Meenen', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Sanne J', 'Initials': 'SJ', 'LastName': 'den Hartog', 'Affiliation': 'Department of Neurology, Erasmus Medical Center, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Adrien E', 'Initials': 'AE', 'LastName': 'Groot', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Smeekes', 'Affiliation': 'Emergency Medical Services North-Holland North, Alkmaar, the Netherlands.'}, {'ForeName': 'Arjen', 'Initials': 'A', 'LastName': 'Siegers', 'Affiliation': 'Ambulance Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'Kommer', 'Affiliation': 'Center for Nutrition, Prevention, and Health Services, National Institute of Public Health and the Environment, Bilthoven, the Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Adriaan C G M', 'Initials': 'ACGM', 'LastName': 'van Es', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Diederik W', 'Initials': 'DW', 'LastName': 'Dippel', 'Affiliation': 'Department of Neurology, Erasmus Medical Center, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'H Bart', 'Initials': 'HB', 'LastName': 'van der Worp', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health, Erasmus Medical Center, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'Department of Neurology, Erasmus Medical Center, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of neurology,['10.1111/ene.15107']
1603,34530059,Child discomfort and parental acceptability of silver diamine fluoride and alternative restorative treatment: A randomized controlled clinical trial.,"OBJECTIVES


To compare pain perception of young children treated with SDF and ART, as well as their parents' acceptability of both modalities.
METHODS


Eighty, 3 to 8-years old children, having at least one deciduous asymptomatic tooth with active caries, as defined by the ICDAS II scores 4, 5, 6 were randomly assigned into two groups; SDF for caries arresting in the test group, and ART for caries removal in the control group. Pain perception was assessed using Sound, Eye, Motor scale (SEM), whereas parental acceptability was assessed using a self-administered questionnaire.
RESULTS


Patients treated with SDF reported significantly less discomfort and pain compared to the ART group, with a mean SEM of 3.70 ± 1.47 and 6.18 ± 3.06, respectively (p < 0.001). A significantly higher mean parental acceptability score was detected for SDF treatment (31.85 ± 2.30) than ART treatment (26.75 ± 3.60), p < 0.001, with regard to the treatment duration, child comfortability and quality of treatment (p < 0.001). The only dimension showing more satisfaction for the ART treatment was esthetics of anterior teeth (p= 0.01).
CONCLUSIONS


Parental acceptability was higher for the SDF caries treatment of primary teeth compared to ART treatment, especially in relation to the shorter intervention time, child comfortability and acceptance as well as quality of treatment.
CLINICAL SIGNIFICANCE


The shorter average time needed and the ease of application of SDF on cavitated primary lesions, in addition to parental acceptability, place SDF in an advantageous position over the ART on clinical level.",2021,"The only dimension showing more satisfaction for the ART treatment was esthetics of anterior teeth (p = 0.01).
","['Eighty, 3 to 8-years old children, having at least one deciduous asymptomatic tooth with active caries, as defined by the ICDAS II scores 4, 5, 6', 'young children treated with']","['Silver Diamine Fluoride and Alternative Restorative Treatment', 'SDF', 'SDF and ART']","['treatment duration, child comfortability and quality of treatment', 'Child Discomfort and Parental Acceptability', 'discomfort and pain', 'Pain perception', 'Sound, Eye, Motor scale (SEM', 'parental acceptability', 'pain perception', 'mean parental acceptability score']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0429170', 'cui_str': 'Caries active'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0415952,"The only dimension showing more satisfaction for the ART treatment was esthetics of anterior teeth (p = 0.01).
","[{'ForeName': 'Amel Mahmoud', 'Initials': 'AM', 'LastName': 'Ali', 'Affiliation': 'Faculty of Dentistry, Alexandria University, Alexandria, Egypt and College of Dentistry, Preventive Dental Sciences Department, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hoda Mahmoud', 'Initials': 'HM', 'LastName': 'Abdellatif', 'Affiliation': 'College of Dentistry, Preventive Dental Sciences Department, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sarah Ibrahim', 'Initials': 'SI', 'LastName': 'Baghdady', 'Affiliation': 'Faculty of Dentistry, Alexandria University, Champollion Street, Azaritah, Alexandria, Egypt. Electronic address: sara.baghdady@alexu.edu.eg.'}, {'ForeName': 'Wafaa Essameldin', 'Initials': 'WE', 'LastName': 'Abdelaziz', 'Affiliation': 'Faculty of Dentistry, Alexandria University, Champollion Street, Azaritah, Alexandria, Egypt.'}, {'ForeName': 'Mona Abdallah', 'Initials': 'MA', 'LastName': 'Elkateb', 'Affiliation': 'Faculty of Dentistry, Alexandria University, Alexandria, Egypt and College of Dentistry, Preventive Dental Sciences Department, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103811']
1604,34529503,"Prevention of Sexually Transmitted Diseases and Pregnancy Prevention Among Native American Youths: A Randomized Controlled Trial, 2016-2018.","Objectives.  To evaluate the efficacy of the Respecting the Circle of Life program (RCL) among Native American youths 11 to 19 years of age residing in a rural reservation community in the southwestern United States.  Methods.  Between 2016 and 2018, we conducted a randomized controlled trial of the RCL program with 534 Native youths. Participants completed assessments at baseline and 9 and 12 months after the intervention. We conducted intention-to-treat analyses based on study group randomization.  Results.  At 9 months, intervention participants had significantly better condom use self-efficacy ( P  < .001), higher intentions to use condoms ( P  = .024) and abstain from sex ( P  = .008), and better contraceptive use self-efficacy ( P  < .001) than control participants, as well as better condom use ( P  = .032) and contraceptive use ( P  = .002) negotiation skills. At 12 months, intervention participants had significantly better sexual and reproductive health knowledge ( P  = .021), condom use self-efficacy ( P  < .001), contraceptive use self-efficacy ( P  < .001), and contraceptive use negotiation skills ( P  = .004) than control participants. Intervention participants reported significantly more communication with their parents about sexual and reproductive health than control participants at both 9 and 12 months ( P  = .042 and  P  = .001, respectively).  Conclusions.  The RCL program has a significant impact on key factors associated with pregnancy prevention among Native youths and should be used as an adolescent pregnancy prevention strategy.  Trial Registration.   Clinical Trials.gov identifier: NCT02904629. ( Am J Public Health . 2021;111(10): 1874-1884. https://doi.org/10.2105/AJPH.2021.306447).",2021,"Intervention participants reported significantly more communication with their parents about sexual and reproductive health than control participants at both 9 and 12 months ( P  = .042 and  P  = .001, respectively).  ","['Native American Youths', 'Native American youths 11 to 19 years of age residing in a rural reservation community in the southwestern United States', '2016-2018', '534 Native youths']","['Respecting the Circle of Life program (RCL', 'RCL']","['contraceptive use self-efficacy', 'contraceptive use negotiation skills', 'better sexual and reproductive health knowledge', 'condom use self-efficacy', 'communication with their parents about sexual and reproductive health', 'higher intentions to use condoms']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}]","[{'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0877959,"Intervention participants reported significantly more communication with their parents about sexual and reproductive health than control participants at both 9 and 12 months ( P  = .042 and  P  = .001, respectively).  ","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Tingey', 'Affiliation': 'The authors are with the Bloomberg School of Public Health, Center for American Indian Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Chambers', 'Affiliation': 'The authors are with the Bloomberg School of Public Health, Center for American Indian Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Hima', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'The authors are with the Bloomberg School of Public Health, Center for American Indian Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Littlepage', 'Affiliation': 'The authors are with the Bloomberg School of Public Health, Center for American Indian Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Shauntel', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'The authors are with the Bloomberg School of Public Health, Center for American Indian Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Angelita', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'The authors are with the Bloomberg School of Public Health, Center for American Indian Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Davette', 'Initials': 'D', 'LastName': 'Susan', 'Affiliation': 'The authors are with the Bloomberg School of Public Health, Center for American Indian Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Melgar', 'Affiliation': 'The authors are with the Bloomberg School of Public Health, Center for American Indian Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Slimp', 'Affiliation': 'The authors are with the Bloomberg School of Public Health, Center for American Indian Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Rosenstock', 'Affiliation': 'The authors are with the Bloomberg School of Public Health, Center for American Indian Health, Johns Hopkins University, Baltimore, MD.'}]",American journal of public health,['10.2105/AJPH.2021.306447']
1605,34533832,Clinico-radiographic comparative evaluation of 1% metformin gel plus platelet-rich fibrin over platelet-rich fibrin alone in treatment of Grade II furcation defects: A randomized controlled double-blind clinical trial.,"BACKGROUND


The present study was aimed to evaluate and compare the effects of 1% MF plus PRF over PRF alone in treatment of Grade II furcation defects, clinically and radiographically by using cone-beam computed tomography.
METHODS


This split-mouth clinical trial randomly allotted 21 patients with 42 bilateral Grade II furcation defects into two groups. Group I was treated with PRF alone while Group II with 1% MF gel and PRF. The primary outcome parameters were clinical attachment level (CAL) and horizontal probing depth (HPD) while the secondary outcome parameters were probing depth (PD) and defect volume (DV). The clinical parameters were evaluated at 3, 6, and 12 months and the radiographic parameters at 12 months.
RESULTS


Both the study groups yielded improvements in assessed parameters; however, significantly greater mean reduction of PD, HPD, and CAL gain was observed in Group II (3.90 ± 0.78 mm, 2.94 ± 0.80 mm, and 3.42 ± 0.93 mm) in comparison with Group I (3.23 ± 0.90 mm, 1.96 ± 0.80 mm, and 2.67 ± 0.88 mm) at 12 months, respectively. A significant reduction of DV was exhibited radiographically in Group II (12.61 ± 4.01 mm 3  ) as compared with Group I (9.14 ± 4.31 mm 3  ) at the end of 12 months.
CONCLUSIONS


Better clinical and radiographic findings in terms of reduction in PD, HPD, CAL gain, and significant reduction in DV in Group II patients indicated that the combination therapy of 1% MF + PRF promotes regenerative ability within the periodontal tissues in Grade II furcation defects to a greater extent.",2021,"Both the study groups yielded improvements in assessed parameters however, significantly greater mean reduction of PPD, HPD and CAL gain was observed in Group II (3.90 ± 0.78mm, 2.94 ± 0.80mm and 3.42 ± 0.93mm) in comparison to Group I (3.23 ± 0.90mm, 1.96 ± 0.80mm and 2.67 ± 0.88mm) at 12 months respectively.","['Grade II Furcation Defects', '21 patients with 42 bilateral Grade II furcation defects into two groups']","['Metformin gel plus Platelet Rich Fibrin over Platelet Rich Fibrin alone', 'PRF alone while Group II with 1%MF gel and PRF', '1%MF plus PRF', '1%MF + PRF']","['PPD and HPD, CAL gain', 'Probing pocket depth (PPD) and Defect volume (DV', 'Clinical attachment level (CAL) and Horizontal probing depth (HPD', 'mean reduction of PPD, HPD and CAL gain', 'DV']","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0206306', 'cui_str': 'Furcation Defects'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0033374', 'cui_str': 'Prolactin releasing factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",21.0,0.0210051,"Both the study groups yielded improvements in assessed parameters however, significantly greater mean reduction of PPD, HPD and CAL gain was observed in Group II (3.90 ± 0.78mm, 2.94 ± 0.80mm and 3.42 ± 0.93mm) in comparison to Group I (3.23 ± 0.90mm, 1.96 ± 0.80mm and 2.67 ± 0.88mm) at 12 months respectively.","[{'ForeName': 'Renuka K', 'Initials': 'RK', 'LastName': 'Swami', 'Affiliation': 'Department of Periodontics & Implantology, VSPM Dental College and Research Centre, Nagpur, Maharashtra, India.'}, {'ForeName': 'Abhay P', 'Initials': 'AP', 'LastName': 'Kolte', 'Affiliation': 'Department of Periodontics & Implantology, VSPM Dental College and Research Centre, Nagpur, Maharashtra, India.'}, {'ForeName': 'Rajashri A', 'Initials': 'RA', 'LastName': 'Kolte', 'Affiliation': 'Department of Periodontics & Implantology, VSPM Dental College and Research Centre, Nagpur, Maharashtra, India.'}]",Journal of periodontology,['10.1002/JPER.21-0233']
1606,34536218,Articular and Extra-Articular Benefits in ACR20 Non-responders at Week 104 Treated With Apremilast: Pooled Analysis of Three Randomized Controlled Trials.,"INTRODUCTION


PALACE 1, 2, and 3 were phase 3 studies aimed to evaluate apremilast efficacy and safety in patients with active psoriatic arthritis (PsA) despite prior treatment with conventional disease-modifying anti-rheumatic drugs and/or biologics. The pooled analysis reported here further characterized the clinical outcomes associated with long-term apremilast exposure in patients failing to achieve ≥ 20% improvement in the American College of Rheumatology response criteria (ACR20) at Week 104.
METHODS


Patients randomized to apremilast 30 mg twice daily at baseline and classified as ACR20 non-responders (ACR20NRs) or ACR20 responders (ACR20Rs) at Week 104 were included. Efficacy outcomes included change from baseline to Week 104 in ACR core components and other endpoints.
RESULTS


At Week 104, a total of 109 patients were ACR20NRs and 193 were ACR20Rs. As expected, the ACR20R group had improvements in all indices assessed. The ACR20NR group demonstrated substantial mean improvements from baseline in swollen joint count (SJC; - 58%), tender joint count (TJC; - 42%), and Physician's Global Assessment of Disease Activity (PhGA; - 44%); resolution of enthesitis (34%) and dactylitis (68%); and achievement of ≥ 75% reduction from baseline Psoriasis Area and Severity Index scores (among patients with psoriasis involving ≥ 3% of the body surface area) (36%).
CONCLUSION


Despite not fulfilling a formal ACR20 response at Week 104, ACR20NRs experienced sustained improvements in several PsA core domains, including SJC, TJC, enthesitis, dactylitis, and psoriasis, as well as the PhGA (visual analog scale) scores, with apremilast treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01172938, NCT01212757, and NCT01212770.",2021,"The ACR20NR group demonstrated substantial mean improvements from baseline in swollen joint count (SJC; - 58%), tender joint count (TJC; - 42%), and Physician's Global Assessment of Disease Activity","['Patients randomized to apremilast 30', 'patients with active psoriatic arthritis (PsA) despite prior treatment with conventional disease-modifying anti-rheumatic drugs and/or biologics']",['Apremilast'],"['baseline Psoriasis Area and Severity Index scores', 'swollen joint count', 'resolution of enthesitis', 'tender joint count', ""Physician's Global Assessment of Disease Activity"", 'several PsA core domains, including SJC, TJC, enthesitis, dactylitis, and psoriasis, as well as the PhGA (visual analog scale) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1678805', 'cui_str': 'apremilast'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C1678805', 'cui_str': 'apremilast'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C0163803', 'cui_str': 'N-phthaloylglutamic acid'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",109.0,0.212734,"The ACR20NR group demonstrated substantial mean improvements from baseline in swollen joint count (SJC; - 58%), tender joint count (TJC; - 42%), and Physician's Global Assessment of Disease Activity","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, USA. pmease@philipmease.com.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California, San Diego, School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'McGonagle', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Griffith University School of Medicine, Brisbane, QLD, Australia.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Guerette', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Nakasato', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Brunori', 'Affiliation': 'Amgen Europe GmbH, Rotkreuz, Switzerland.'}, {'ForeName': 'Lichen', 'Initials': 'L', 'LastName': 'Teng', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}]",Rheumatology and therapy,['10.1007/s40744-021-00369-x']
1607,34543081,"Neurocognitive Outcomes from Memantine: A Pilot, Double-Blind, Placebo-Controlled Trial in Children with Autism Spectrum Disorder.","Objective:  Studies interrogating therapeutics which alter the excitation-inhibition balance in the treatment of autism spectrum disorder (ASD) have reported mixed results on social and behavioral outcomes.  Methods:  The aim of this randomized, double-blind placebo-controlled pilot trial was to evaluate neurocognitive effects of memantine over a 24-week trial. Twenty-three children ages 6-12 years old with ASD were randomized to memantine or placebo. Primary outcomes included measures of apraxia and expressive language with evaluations at midpoint (week 12) and endpoint (week 24). Secondary outcomes included memory and adaptive behavior measures. Exploratory outcomes included changes in overall cognitive functioning and behavior (e.g., Aberrant Behavior Checklist).  Results:  Results suggest that memantine was well-tolerated. Dropout rates were high across groups with only 14 participants completing the 6-month trial. Memantine was not associated with improvements in apraxia and expressive language. Treatment with memantine was associated with improvements in verbal recognition memory as measured by the Narrative Memory-Recognition (NEPSY-II) ( F  = 5.05,  p  = .03). In addition, exploratory analyses of changes in Intelligence quotient (IQ) suggest improvements on verbal IQ ( d  = 1.8).  Conclusions:  Results suggest future studies of memantine in ASD may benefit from shifting treatment targets from social and behavioral outcomes to exploration of effects of memantine on cognition, potentially as an adjunct to learning and educational interventions. ClinicalTrials.gov: NCT01372449.",2021,Treatment with memantine was associated with improvements in verbal recognition memory as measured by the Narrative Memory-Recognition (NEPSY-II) (,"['autism spectrum disorder (ASD', 'Children with Autism Spectrum Disorder', 'Twenty-three children ages 6-12 years old with ASD']","['Placebo', 'memantine', 'Memantine', 'placebo', 'memantine or placebo']","['measures of apraxia and expressive language with evaluations', 'Dropout rates', 'apraxia and expressive language', 'Narrative Memory-Recognition (NEPSY-II) ', 'verbal IQ', 'verbal recognition memory', 'neurocognitive effects', 'tolerated', 'overall cognitive functioning and behavior (e.g., Aberrant Behavior Checklist', 'memory and adaptive behavior measures']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003635', 'cui_str': 'Apraxia'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0085880', 'cui_str': 'Adaptation behavior'}]",23.0,0.558468,Treatment with memantine was associated with improvements in verbal recognition memory as measured by the Narrative Memory-Recognition (NEPSY-II) (,"[{'ForeName': 'Latha Valluripalli', 'Initials': 'LV', 'LastName': 'Soorya', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fogg', 'Affiliation': 'Department of Nursing, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Ocampo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Printen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Youngkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Halpern', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine, New York, New York, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine, New York, New York, USA.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grodberg', 'Affiliation': 'Child Study Center, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Evdokia', 'Initials': 'E', 'LastName': 'Anagnostou', 'Affiliation': ""Holland Bloorview Children's Rehabilitation Hospital, Ontario, Canada.""}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2021.0010']
1608,34520520,"Intrathecal Morphine for Analgesia in Minimally Invasive Cardiac Surgery: A Randomized, Placebo-controlled, Double-blinded Clinical Trial.","BACKGROUND


Intrathecal morphine decreases postoperative pain in standard cardiac surgery. Its safety and effectiveness have not been adequately evaluated in minimally invasive cardiac surgery. The authors hypothesized that intrathecal morphine would decrease postoperative morphine consumption after minimally invasive cardiac surgery.
METHODS


In this randomized, placebo-controlled, double-blinded clinical trial, patients undergoing robotic totally endoscopic coronary artery bypass received either intrathecal morphine (5 mcg/kg) or intrathecal saline before surgery. The primary outcome was postoperative morphine equivalent consumption in the first 24 h after surgery; secondary outcomes included pain scores, side effects, and patient satisfaction. Pain was assessed via visual analog scale at 1, 2, 6, 12, 24, and 48 h after intensive care unit arrival. Opioid-related side effects (nausea/vomiting, pruritus, urinary retention, respiratory depression) were assessed daily. Patient satisfaction was evaluated with the Revised American Pain Society Outcome Questionnaire.
RESULTS


Seventy-nine patients were randomized to receive intrathecal morphine (n = 37) or intrathecal placebo (n = 42), with 70 analyzed (morphine 33, placebo 37). Intrathecal morphine patients required significantly less median (25th to 75th percentile) morphine equivalents compared to placebo during first postoperative 24 h (28 [16 to 46] mg vs. 59 [41 to 79] mg; difference, -28 [95% CI, -40 to -18]; P < 0.001) and second postoperative 24 h (0 [0 to 2] mg vs. 5 [0 to 6] mg; difference, -3.3 [95% CI, -5 to 0]; P < 0.001), exhibited significantly lower visual analog scale pain scores at rest and cough at all postoperative timepoints (overall treatment effect, -4.1 [95% CI, -4.9 to -3.3] and -4.7 [95% CI, -5.5 to -3.9], respectively; P < 0.001), and percent time in severe pain (10 [0 to 40] vs. 40 [20 to 70]; P = 0.003) during the postoperative period. Mild nausea was more common in the intrathecal morphine group (36% vs. 8%; P = 0.004).
CONCLUSIONS


When given before induction of anesthesia for totally endoscopic coronary artery bypass, intrathecal morphine decreases use of postoperative opioids and produces significant postoperative analgesia for 48 h.
EDITOR’S PERSPECTIVE


",2021,"Mild nausea was more common in the intrathecal morphine group (36% vs. 8%; P = 0.004).
","['patients undergoing robotic totally endoscopic coronary artery bypass', 'standard cardiac surgery', 'Seventy-nine patients']","['placebo', 'intrathecal morphine', 'intrathecal placebo', '70 analyzed (morphine 33, placebo', 'Invasive Cardiac Surgery', 'morphine', 'Intrathecal Morphine', 'intrathecal saline', 'Placebo', 'Intrathecal morphine']","['Opioid-related side effects (nausea/vomiting, pruritus, urinary retention, respiratory depression', 'postoperative morphine consumption', 'Patient satisfaction', 'percent time in severe pain', 'Mild nausea', 'pain scores, side effects, and patient satisfaction', 'Pain', 'visual analog scale pain scores', 'postoperative pain', 'postoperative morphine equivalent consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",79.0,0.753323,"Mild nausea was more common in the intrathecal morphine group (36% vs. 8%; P = 0.004).
","[{'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Dhawan', 'Affiliation': 'From the Department of Anesthesia and Critical Care, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Danisa', 'Initials': 'D', 'LastName': 'Daubenspeck', 'Affiliation': 'From the Department of Anesthesia and Critical Care, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Kristen E', 'Initials': 'KE', 'LastName': 'Wroblewski', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John-Henry', 'Initials': 'JH', 'LastName': 'Harrison', 'Affiliation': 'Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'McCrorey', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Husam H', 'Initials': 'HH', 'LastName': 'Balkhy', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Chaney', 'Affiliation': 'From the Department of Anesthesia and Critical Care, University of Chicago Medicine, Chicago, Illinois.'}]",Anesthesiology,['10.1097/ALN.0000000000003963']
1609,34520506,"The influence of neuromuscular blockade on phase lag entropy and bispectral index: A randomized, controlled trial.","The aim of this study is to compare the effects of neuromuscular blockade (NMB) on phase lag entropy (PLE) and the bispectral index (BIS). We recorded the BIS, electromyograph (EMG) activity on a BIS monitor (EMG_BIS), PLE, and EMG activity on a PLE monitor (EMG_PLE) in 40 patients receiving general anesthesia. During the awake state, we analyzed the changes in parameters before and 2 min after the eyes were closed. During sedation, we compared the changes in the parameters before and at 4 min after injecting rocuronium (group R) or normal saline (group C) between the two groups. During anesthesia, we compared the changes in parameters before and at 4 min after injecting sugammadex (group B) or normal saline (group D) between the two groups. During the awake state, the BIS, EMG_BIS, and EMG_PLE, but not PLE, decreased significantly with closed eyes. An effect of EMG on the BIS was evident, but not on PLE. During sedation, the BIS decreased with the decrease in EMG_BIS regardless of NMB caused by rocuronium, but NMB decreased PLE, although the degree of the decrease in EMG_PLE after NMB was similar to that after placebo. To determine the effect of NMB on electroencephalograms (EEGs) in groups R and C, we plotted the power spectra before and at 4 min after injecting rocuronium or normal saline. Changes in slow and delta frequency bands were observed at 4 min after injecting rocuronium relative to before injecting rocuronium. There was no effect of EMG on either the BIS or PLE during anesthesia. In conclusion, the effect of electromyograph activity and/or neuromuscular blockade on BIS or PLE depends on the level of consciousness.",2021,Changes in slow and delta frequency bands were observed at 4 min after injecting rocuronium relative to before injecting rocuronium.,['40 patients receiving general anesthesia'],"['normal saline', 'NMB', 'rocuronium or normal saline', 'rocuronium', 'EMG', 'neuromuscular blockade', 'neuromuscular blockade (NMB']","['Changes in slow and delta frequency bands', 'BIS, electromyograph (EMG) activity on a BIS monitor (EMG_BIS), PLE, and EMG activity on a PLE monitor (EMG_PLE', 'phase lag entropy (PLE) and the bispectral index (BIS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0180677', 'cui_str': 'Electromyograph'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0180677', 'cui_str': 'Electromyograph'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2717896', 'cui_str': 'Bispectral Index Monitor'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0449200', 'cui_str': 'PLE'}]",40.0,0.053875,Changes in slow and delta frequency bands were observed at 4 min after injecting rocuronium relative to before injecting rocuronium.,"[{'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei Barun Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Jung', 'Initials': 'HJ', 'LastName': 'Baik', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, Ewha Womans University, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sooyoung', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, Ewha Womans University, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Rack Kyung', 'Initials': 'RK', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, Ewha Womans University, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung Ae', 'Initials': 'KA', 'LastName': 'Kong', 'Affiliation': 'Department of Preventive Medicine, College of Medicine, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Youn Jin', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, Ewha Womans University, Ewha Womans University Seoul Hospital, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0257467']
1610,34523948,Gut Microbiota Serves a Predictable Outcome of Short-Term Low-Carbohydrate Diet (LCD) Intervention for Patients with Obesity.,"To date, much progress has been made in dietary therapy for obese patients. A low-carbohydrate diet (LCD) has reached a revival in its clinical use during the past decade with undefined mechanisms and debatable efficacy. The gut microbiota has been suggested to promote energy harvesting. Here, we propose that the gut microbiota contributes to the inconsistent outcome under an LCD. To test this hypothesis, patients with obesity or patients who were overweight were randomly assigned to a normal diet (ND) or an LCD group with  ad libitum  energy intake for 12 weeks. Using matched sampling, the microbiome profile at baseline and end stage was examined. The relative abundance of butyrate-producing bacteria, including  Porphyromonadaceae Parabacteroides  and  Ruminococcaceae Oscillospira , was markedly increased after LCD intervention for 12 weeks. Moreover, within the LCD group, participants with a higher relative abundance of  Bacteroidaceae Bacteroides  at baseline exhibited a better response to LCD intervention and achieved greater weight loss outcomes. Nevertheless, the adoption of an artificial neural network (ANN)-based prediction model greatly surpasses a general linear model in predicting weight loss outcomes after LCD intervention. Therefore, the gut microbiota served as a positive outcome predictor and has the potential to predict weight loss outcomes after short-term LCD intervention. Gut microbiota may help to guide the clinical application of short-term LCD intervention to develop effective weight loss strategies. (This study has been registered at the China Clinical Trial Registry under approval no. ChiCTR1800015156).  IMPORTANCE  Obesity and its related complications pose a serious threat to human health. Short-term low-carbohydrate diet (LCD) intervention without calorie restriction has a significant weight loss effect for overweight/obese people. Furthermore, the relative abundance of  Bacteroidaceae Bacteroides  is a positive outcome predictor of individual weight loss after short-term LCD intervention. Moreover, leveraging on these distinct gut microbial structures at baseline, we have established a prediction model based on the artificial neural network (ANN) algorithm that could be used to estimate weight loss potential before each clinical trial (with Chinese patent number 2021104655623). This will help to guide the clinical application of short-term LCD intervention to improve weight loss strategies.",2021,"The relative abundance of butyrate-producing bacteria, including  Porphyromonadaceae Parabacteroides  and  Ruminococcaceae Oscillospira , was markedly increased after LCD intervention for 12 weeks.","['Patients with Obesity', 'overweight/obese people', 'obese patients', 'patients with obesity or patients who were overweight']","['Short-term low-carbohydrate diet ', 'LCD intervention', 'low-carbohydrate diet (LCD', 'Carbohydrate Diet (LCD) Intervention', 'LCD) intervention without calorie restriction', 'normal diet (ND) or an LCD group with  ad libitum  energy intake']","['individual weight loss', 'weight loss outcomes', 'relative abundance of butyrate-producing bacteria, including  Porphyromonadaceae Parabacteroides  and  Ruminococcaceae Oscillospira']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1080665', 'cui_str': 'Porphyromonadaceae'}, {'cui': 'C1927848', 'cui_str': 'Parabacteroides'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C1057550', 'cui_str': 'Oscillospira'}]",,0.0407774,"The relative abundance of butyrate-producing bacteria, including  Porphyromonadaceae Parabacteroides  and  Ruminococcaceae Oscillospira , was markedly increased after LCD intervention for 12 weeks.","[{'ForeName': 'Susu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}, {'ForeName': 'Peili', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}, {'ForeName': 'Bingdong', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Applied Microbiology Southern China, Guangdong Provincial Key Laboratory of Microbial Culture Collection and Application, Guangdong Open Laboratory of Applied Microbiology, Institute of Microbiology, Guangdong Academy of Sciences, Guangzhou, China.'}, {'ForeName': 'Liujing', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Applied Microbiology Southern China, Guangdong Provincial Key Laboratory of Microbial Culture Collection and Application, Guangdong Open Laboratory of Applied Microbiology, Institute of Microbiology, Guangdong Academy of Sciences, Guangzhou, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Applied Microbiology Southern China, Guangdong Provincial Key Laboratory of Microbial Culture Collection and Application, Guangdong Open Laboratory of Applied Microbiology, Institute of Microbiology, Guangdong Academy of Sciences, Guangzhou, China.'}, {'ForeName': 'Nie', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Nephrology Center of Integrated Traditional Chinese and Western Medicine, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}, {'ForeName': 'Zongbing', 'Initials': 'Z', 'LastName': 'Cui', 'Affiliation': 'State Key Laboratory of Applied Microbiology Southern China, Guangdong Provincial Key Laboratory of Microbial Culture Collection and Application, Guangdong Open Laboratory of Applied Microbiology, Institute of Microbiology, Guangdong Academy of Sciences, Guangzhou, China.'}, {'ForeName': 'HongWei', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Organ Failure Research, Microbiome Medicine Center, Division of Laboratory Medicine, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical Universitygrid.284723.8, Guangzhou, China.'}]",Microbiology spectrum,['10.1128/Spectrum.00223-21']
1611,34525239,"A prospective, randomized, controlled clinical study on the effectiveness of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of diabetic ulcers of the lower extremities.","A multicenter, phase 4, randomized, comparative-efficacy study in subjects with lower extremity wounds was carried out to compare wound closure rates, for a single-use negative pressure wound therapy (s-NPWT) versus traditional NPWT (t-NPWT) systems over a 12-week treatment period. From the initial population of patients with diabetic foot ulcers (DFU) and venous leg ulcers (VLU), we analyzed a subgroup of patients with diabetes mellitus and leg and foot ulcers (either DFUs or VLUs in diabetics), termed, the diabetic lower extremity ulcers (DLEU). In the DLEU group, there were 95 patients in intention-to-treat (ITT) and 61 patients in per protocol (PP) populations, respectively. We found a significant difference in favor of s-NPWT over t-NPWT in the confirmed wound closures at 12 weeks both in ITT (p < 0.001) and PP populations (p = 0.017). Significantly higher wound closure rates in s-NPWT group suggest that s-NPWT should be preferred NPWT option for DLEU.",2021,We found a significant difference in favor of s-NPWT over t-NPWT in the confirmed wound closures at 12 weeks both in ITT (p < 0.001) and PP populations (p = 0.017).,"['diabetic ulcers of the lower extremities', 'subjects with lower extremity wounds', 'patients with diabetes mellitus and leg and foot ulcers (either DFUs or VLUs in diabetics), termed, the diabetic lower extremity ulcers (DLEU', 'patients with diabetic foot ulcers (DFU) and venous leg ulcers (VLU']","['traditional negative pressure wound therapy', 'single-use negative pressure wound therapy system', 'single-use negative pressure wound therapy (s-NPWT) versus traditional NPWT (t-NPWT) systems']",['wound closure rates'],"[{'cui': 'C0743150', 'cui_str': 'Diabetic ulcer'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0023223', 'cui_str': 'Ulcer of lower extremity'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",95.0,0.00919513,We found a significant difference in favor of s-NPWT over t-NPWT in the confirmed wound closures at 12 weeks both in ITT (p < 0.001) and PP populations (p = 0.017).,"[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kirsner', 'Affiliation': 'Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Zimnitsky', 'Affiliation': 'Global Clinical Strategy, Smith+Nephew, Cary, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Global Data Analytics, Smith+Nephew, Hull, UK.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12966']
1612,34547193,Mirabegron improves the irritative symptoms caused by BCG immunotherapy after transurethral resection of bladder tumors.,"BACKGROUND


This study aims to explore the efficacy and safety of mirabegron in treating irritative symptoms induced by intravesical immunotherapy with Bacillus Calmette-Guerin (BCG) after transurethral resection of bladder tumors (TURBT).
METHODS


A total of 160 patients subjected to TURBT was randomly divided into the mirabegron group and placebo group with 80 patients in each group. Then, the patients were administered 25 mg mirabegron or placebo daily, starting the first day after BCG infusion. The first BCG perfusion was conducted at least 2 weeks after TURBT. The 3-day bladder diaries were completed in all patients, 1 day before BCG perfusion, and on the 1st, 6th, and 13th days after the first BCG perfusion. Overactive bladder symptom scores were completed 1 day before BCG perfusion, and on the 6th and 13th days after the first BCG perfusion.
RESULTS


Symptom scores of bladder hyperactivity were significantly different between the two groups (p < 0.001). Also, the frequency of nocturia, pollakiuria, micturition urgency, urinary incontinence and was significantly lower in group 1 than that in group two (p < 0.05).
CONCLUSION


Our findings demonstrate that mirabegron is a valuable clinical drug for the management of irritative symptoms after TURBT with subsequent intravesical BCG perfusion.",2021,"RESULTS


Symptom scores of bladder hyperactivity were significantly different between the two groups (p < 0.001).",['160 patients subjected to TURBT'],"['intravesical immunotherapy with Bacillus Calmette-Guerin (BCG', 'placebo', 'BCG immunotherapy']","['Symptom scores of bladder hyperactivity', 'irritative symptoms', 'frequency of nocturia, pollakiuria, micturition urgency, urinary incontinence', 'Overactive bladder symptom scores', '3-day bladder diaries']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}]","[{'cui': 'C4552477', 'cui_str': 'Intravesical immunotherapy'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}]",160.0,0.0511188,"RESULTS


Symptom scores of bladder hyperactivity were significantly different between the two groups (p < 0.001).","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.'}, {'ForeName': 'Tianqi', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.'}, {'ForeName': 'Jitao', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.'}, {'ForeName': 'Jipeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.'}]",Cancer medicine,['10.1002/cam4.4278']
1613,34551263,Effects of a Health Promotion Intervention on Physical Activity in African American Men Living with HIV: Randomized Controlled Trial.,"HIV and its treatment with antiretroviral therapy increase the risk of noncommunicable diseases (NCDs) tied to physical inactivity. Older African American men are also at high risk for NCDs. We tested the efficacy of a theory-based intervention to increase adherence to federal aerobic and muscle-strengthening physical activity (PA) guidelines among African American men aged 40 years and older living with HIV. We randomized African American men aged 40 years and older living with HIV to a three-session social cognitive theory-informed health promotion intervention targeting PA or a one-session health awareness control condition. The primary outcome was PA guideline adherence assessed (self-reported) preintervention, immediate postintervention, and 3, 6, and 12 months postintervention. Secondary outcomes were the number of days on which participants reported moderate-intensity aerobic PA, vigorous-intensity aerobic PA, and muscle-strengthening PA in the past 7 days. Of 302 participants, 255 completed the 12-month postintervention measures. Generalized estimated equation logistic regression indicated that the health promotion intervention participants had higher odds of meeting PA guidelines than health awareness control participants, adjusting for baseline adherence ( p  = 0.011). Health promotion intervention participants also reported more muscle-strengthening PA ( p  = 0.001), vigorous-intensity aerobic PA ( p  = 0.049), and moderate-intensity aerobic PA ( p  = 0.010) than control participants. The rise in self-reported adherence to PA guidelines and improvements in muscle-strengthening and aerobic PA considered separately suggest that a relatively brief behavioral intervention can increase PA among African American men aged 40 years and older living with HIV and potentially curb their risk of NCDs that PA can prevent.",2021,"Health promotion intervention participants also reported more muscle-strengthening PA ( p  = 0.001), vigorous-intensity aerobic PA ( p  = 0.049), and moderate-intensity aerobic PA ( p  = 0.010) than control participants.","['Of 302 participants, 255 completed the 12-month postintervention measures', 'Older African American men', 'African American Men Living with HIV', 'African American men aged 40 years and older living with HIV', 'African American men aged 40 years and older living with HIV to a three-session social cognitive theory-informed health promotion intervention targeting PA or a one-session health awareness control condition']","['antiretroviral therapy', 'behavioral intervention', 'Health Promotion Intervention', 'theory-based intervention', 'federal aerobic and muscle-strengthening physical activity (PA) guidelines']","['vigorous-intensity aerobic PA', 'moderate-intensity aerobic PA', 'muscle-strengthening PA', 'number of days on which participants reported moderate-intensity aerobic PA, vigorous-intensity aerobic PA, and muscle-strengthening PA in the past 7 days', 'PA guideline adherence assessed (self-reported) preintervention, immediate postintervention', 'Physical Activity']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",302.0,0.0390968,"Health promotion intervention participants also reported more muscle-strengthening PA ( p  = 0.001), vigorous-intensity aerobic PA ( p  = 0.049), and moderate-intensity aerobic PA ( p  = 0.010) than control participants.","[{'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Jemmott', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Loretta S', 'Initials': 'LS', 'LastName': 'Jemmott', 'Affiliation': 'College of Nursing and Health Professions, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Communication and University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Icard', 'Affiliation': 'School of Social Work, College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Terri-Ann', 'Initials': 'TA', 'LastName': 'Kelly', 'Affiliation': 'School of Nursing, Rutgers University, Camden, New Jersey, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Scarlett L', 'Initials': 'SL', 'LastName': 'Bellamy', 'Affiliation': 'Department of Epidemiology and Biostatistics, Dornsife School of Public Health, Drexel University, Philadelphia, Pennsylvania, USA.'}]",AIDS patient care and STDs,['10.1089/apc.2021.0039']
1614,34554352,"Pharmacokinetics and Safety of Intravenous and Subcutaneous Auto-injector Single-dose Belimumab in Healthy Chinese Volunteers: A phase 1, Randomized, Open-label Study.","INTRODUCTION


Belimumab is a recombinant human immunoglobulin G1λ monoclonal antibody indicated as an intravenous (IV) 10 mg/kg and subcutaneous (SC) 200-mg dose for the treatment of systemic lupus erythematosus (SLE). Belimumab 10 mg/kg IV has been approved for the treatment of patients with SLE in China. This phase 1 study investigated the pharmacokinetics (PK), safety, and tolerability of belimumab 200 mg SC and the approved IV formulation in a healthy Chinese population.
METHODS


This was a 13-week open-label, randomized, parallel-group study in healthy Chinese volunteers. Eligible volunteers were randomized (1:2) to receive a single dose of IV or SC (via auto-injector) belimumab 200 mg. PK and safety endpoints were evaluated using descriptive statistics.
RESULTS


Thirty-six healthy Chinese volunteers were enrolled and all completed the study. Concentration-time profiles were as expected for both formulations. Overall, 130 adverse events (AEs) were reported, with 28 AEs reported in 11 (91.7%) volunteers in the IV group and 102 AEs in 24 (100%) volunteers in the SC group. Of the 130 AEs, 104 (80.0%) were considered to be treatment-related (27 [20.8% of total AEs] treatment-related AEs in the IV group; 77 [59.2% of total AEs] in the SC group). Although the occurrence of AEs was higher in the SC group, most volunteers (91.7%) experienced AEs of mild intensity. The most frequently reported AEs included injection site pain (n = 19 [79.2%]) and oropharyngeal pain (n = 5 [20.8%]) in the SC group, and positive bacterial test, upper respiratory tract infection, blood uric acid increase, white blood cell count increase, asthenia, and diarrhea (n = 2 [16.7%], each) in the IV group.
CONCLUSIONS


PK profiles of 200 mg SC and IV belimumab administrations were similar to previous studies, and safety profiles were acceptable, supporting the use of the SC dose in Chinese patients with SLE.
TRIAL REGISTRATION


NCT04136145.",2021,"Overall, 130 adverse events (AEs) were reported, with 28 AEs reported in 11 (91.7%) volunteers in the IV group and 102 AEs in 24 (100%) volunteers in the SC group.","['healthy Chinese population', 'Thirty-six healthy Chinese volunteers', 'Chinese patients with SLE', 'Healthy Chinese Volunteers', 'Eligible volunteers', 'healthy Chinese volunteers', 'patients with SLE in China']","['Intravenous and Subcutaneous Auto-injector Single-dose Belimumab', 'belimumab 200\xa0mg SC', 'SC (via auto-injector) belimumab 200\xa0mg']","['Pharmacokinetics and Safety', 'Concentration-time profiles', 'oropharyngeal pain', 'PK and safety endpoints', 'occurrence of AEs', 'positive bacterial test, upper respiratory tract infection, blood uric acid increase, white blood cell count increase, asthenia, and diarrhea', 'injection site pain', 'pharmacokinetics (PK), safety, and tolerability']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C2984091', 'cui_str': 'Auto-Injector'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2363731', 'cui_str': 'Oropharyngeal pain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C2242638', 'cui_str': 'Bacterial test'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0235416', 'cui_str': 'Blood urate raised'}, {'cui': 'C0750426', 'cui_str': 'Increased blood leukocyte number'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}]",36.0,0.170738,"Overall, 130 adverse events (AEs) were reported, with 28 AEs reported in 11 (91.7%) volunteers in the IV group and 102 AEs in 24 (100%) volunteers in the SC group.","[{'ForeName': 'Xianmin', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Pharmacy, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Shunquan', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'R&D, GlaxoSmithKline, Shanghai, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Pu', 'Affiliation': 'R&D, GlaxoSmithKline, Shanghai, China.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'R&D, GlaxoSmithKline, Shanghai, China.'}, {'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Fang', 'Affiliation': 'R&D, GlaxoSmithKline, Shanghai, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Shanghai, China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Rd, Jinshan District, Shanghai, China. luhongzhou@fudan.edu.cn.'}]",Rheumatology and therapy,['10.1007/s40744-021-00366-0']
1615,34554308,Displaced three and four part proximal humeral fractures: prospective controlled randomized open-label two-arm study comparing intramedullary nailing and locking plate.,"PURPOSE


The aim of this study was (1) to compare clinical and radiological outcomes of 3- and 4-part proximal humeral fractures using either IMN or LP (2) and to report complications related to each technique.
METHODS


A prospective controlled randomized open-label two-arm study was performed. Ninety-nine consecutive adult patients with a 3- and 4-part displaced acute proximal humeral fractures were randomized to be treated with IMN (n = 49) or LP (n = 50). Constant, ASES and SST scores were recorded by the surgeon. Range of motion was evaluated. A visual analog scale (VAS) was used to assess shoulder pain. Complications and revision surgeries were reported.
RESULTS


Eighty-five patients were analyzed, nine were lost, and five died during the follow-up period. The mean age was 73.7 years (± 13.3,, and the mean follow-up was 66 months (± 13.5). At last follow-up, VAS was lower in the IMN group (0.9 (± 1.1) vs. 1.9 (± 1.7), p = 0.001). The median Constant score was significantly higher in the IMN group (81.6 (± 10.9) points) vs. in the LP group (75.6 (± 19.5) points) (p = 0.043), and ASES score was also significantly higher in the IMN group (86.3 (± 9.5) vs. 75.2 (± 19.6), p = 0.001). There was no difference in the range of motion or SST scores between the two groups. Complications were seen higher in the LP group (9 (21%) vs. 22 (52%), p = 0.003). Revision surgery was higher in the LP group (37% vs. 21%).
CONCLUSION


Satisfactory results were accomplished in both groups according to the reported clinical outcomes. Complication and revision rates were higher in LP group.",2021,"Complications were seen higher in the LP group (9 (21%) vs. 22 (52%), p = 0.003).","['The mean age was 73.7\xa0years (±\u200913.3,, and the mean follow-up was 66\xa0months (±\u200913.5', 'Ninety-nine consecutive adult patients with a 3- and 4-part displaced acute proximal humeral fractures', 'Displaced three and four part proximal humeral fractures']","['IMN', 'IMN or LP (2', 'LP', 'intramedullary nailing and locking plate']","['ASES score', 'visual analog scale (VAS', 'median Constant score', 'range of motion or SST scores', 'Complications and revision surgeries', 'shoulder pain', 'Complications', 'VAS', 'Complication and revision rates', 'Constant, ASES and SST scores', 'Revision surgery']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037006', 'cui_str': 'Fracture of shoulder'}]","[{'cui': 'C0022132', 'cui_str': 'Isle of Man'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037659', 'cui_str': 'Somatostatin'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}]",99.0,0.0242084,"Complications were seen higher in the LP group (9 (21%) vs. 22 (52%), p = 0.003).","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Boyer', 'Affiliation': 'Orthopaedic Surgery Department, Université de Paris, Hôpital, Bichat 46 Henri Huchard, 75018, Paris, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Couffignal', 'Affiliation': 'Clinical Research, Biostatistics and Epidemiology Department, AP-HP, Hôpital Bichat, F-75018, Paris, France.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bahman', 'Affiliation': 'Alrazi Hospital, University of Kuwait, Al Sabah Medical Area, Kuwait, Kuwait.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Mylle', 'Affiliation': 'Clinique Hartmann, Neuilly Sur Seine, France.'}, {'ForeName': 'Marc-Antoine', 'Initials': 'MA', 'LastName': 'Rousseau', 'Affiliation': 'Orthopaedic Surgery Department, Université de Paris, Hôpital, Bichat 46 Henri Huchard, 75018, Paris, France.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Dukan', 'Affiliation': 'Orthopaedic Surgery Department, Université de Paris, Hôpital, Bichat 46 Henri Huchard, 75018, Paris, France. ruben.dukan@gmail.com.'}]",International orthopaedics,['10.1007/s00264-021-05217-9']
1616,34529944,Effect of intensive versus limited monitoring on clinical trial conduct and outcomes: A randomized trial.,"BACKGROUND


Regulatory agencies have endorsed more limited approaches to clinical trial site monitoring. However, the impact of different monitoring strategies on trial conduct and outcomes is unclear.
METHODS


We conducted a patient-level block-randomized controlled trial evaluating the effect of intensive versus limited monitoring on cardiovascular clinical trial conduct and outcomes nested within the CoreValve Continued Access and Expanded Use Studies. Intensive monitoring included complete source data verification of all critical datapoints whereas limited monitoring included automated data checks only. This study's endpoints included clinical trial outcome ascertainment as well as monitoring action items, protocol deviations, and adverse event ascertainment.
RESULTS


A total of 2,708 patients underwent transcatheter aortic valve replacement (TAVR) and were randomized to either intensive monitoring (n = 1,354) or limited monitoring (n = 1,354). Monitoring action items were more common with intensive monitoring (52% vs 15%; P < .001), but there was no difference in the percentage of patients with any protocol deviation (91.6% vs 90.4%; P = .314). The reported incidence of trial outcomes between intensive and limited monitoring was similar for mortality (30 days: 4.8% vs 5.5%, P = .442; 1 year: 20.3% vs 21.3%, P = .473) and stroke (30 days: 2.8% vs 2.4%, P = .458), as well as most secondary trial outcomes with the exception of bleeding (intensive: 36.3% vs limited: 32.0% at 30 days, P = .019). There was a higher reported incidence of cardiac adverse events reported in the intensive monitoring group at 1 year (76.7% vs 72.4%; P = .019).
CONCLUSIONS


Tailored limited monitoring strategies can be implemented without influencing the integrity of TAVR trial outcomes.",2021,"Monitoring action items were more common with intensive monitoring (52% vs 15%; p<0.001), but there was no difference in the percentage of patients with any protocol deviation (91.6% vs 90.4%; p=0.314).",['2708 patients underwent'],"['intensive versus limited monitoring', 'intensive monitoring (n=1354) or limited monitoring', 'transcatheter aortic valve replacement (TAVR']","['stroke', 'monitoring action items, protocol deviations, and adverse event ascertainment', 'cardiac adverse events', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1283169', 'cui_str': 'Monitoring - action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",2708.0,0.253619,"Monitoring action items were more common with intensive monitoring (52% vs 15%; p<0.001), but there was no difference in the percentage of patients with any protocol deviation (91.6% vs 90.4%; p=0.314).","[{'ForeName': 'Neel M', 'Initials': 'NM', 'LastName': 'Butala', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA; Department of Medicine, Cardiology Division, Massachusetts General Hospital, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA.'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA; Biogen Inc, Cambridge, MA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY; St. Francis Hospital, Roslyn, NY.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Yeh', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA; Harvard Medical School, Boston, MA. Electronic address: ryeh@bidmc.harvard.edu.'}]",American heart journal,['10.1016/j.ahj.2021.09.002']
1617,34529931,"Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial.","BACKGROUND


CASSIOPEIA part 1 showed superior depth of response and significantly improved progression-free survival with daratumumab, bortezomib, thalidomide, and dexamethasone (D-VTd) versus bortezomib, thalidomide, and dexamethasone (VTd) as induction and consolidation in patients with autologous stem-cell transplant (ASCT)-eligible newly diagnosed multiple myeloma. In part 2, we compared daratumumab maintenance versus observation only.
METHODS


CASSIOPEIA is a two-part, open-label, randomised, phase 3 trial of patients aged 18-65 years with newly diagnosed multiple myeloma and Eastern Cooperative Oncology Group performance status 0-2, done in 111 European academic and community practice centres. In part 1, patients were randomly assigned (1:1) to induction and consolidation with D-VTd or VTd. Patients still on study who had a partial response or better were randomly assigned (1:1) by an interactive web-response system to daratumumab 16 mg/kg intravenously every 8 weeks (a reduced frequency compared with standard daratumumab long-term dosing) or observation only for up to 2 years. Stratification factors were induction treatment and depth of response in part 1. The part 2 primary endpoint was progression-free survival from second randomisation. This preplanned interim analysis of progression-free survival was done after 281 events and shall be considered the primary analysis of progression-free survival. Sponsor personnel and designees who were involved in the analysis were masked to treatment group until the independent data monitoring committee recommended that the preplanned interim analysis be considered the main analysis of progression-free survival in part 2. Otherwise, treatment assignments were unmasked. The interaction between induction and consolidation and maintenance was tested at a two-sided significance level of 0·05 by a stratified Cox regression model that included the interaction term between maintenance treatment and induction and consolidation treatment. Efficacy analyses were done in the maintenance-specific intention-to-treat population, which comprised all patients who underwent second randomisation. Safety was analysed in all patients in the daratumumab group who received at least one dose and all patients randomly assigned to observation only. This trial is registered with ClinicalTrials.gov, NCT02541383. Long-term follow-up is ongoing and the trial is closed to new participants.
FINDINGS


Between May 30, 2016, and June 18, 2018, 886 patients (458 [84%] of 543 in the D-VTd group and 428 [79%] of 542 in the VTd group) were randomly assigned to daratumumab maintenance (n=442) or observation only (n=444). At a median follow-up of 35·4 months (IQR 30·2-39·9) from second randomisation, median progression-free survival was not reached (95% CI not evaluable [NE]-NE) with daratumumab versus 46·7 months (40·0-NE) with observation only (hazard ratio 0·53, 95% CI 0·42-0·68, p<0·0001). A prespecified analysis of progression-free survival results showed a significant interaction between maintenance and induction and consolidation therapy (p<0·0001). The most common grade 3 or 4 adverse events were lymphopenia (16 [4%] of 440 patients in the daratumumab group vs eight [2%] of 444 patients in the observation-only group), hypertension (13 [3%] vs seven [2%]), and neutropenia (nine [2%] vs ten [2%]). Serious adverse events occurred in 100 (23%) patients in the daratumumab group and 84 (19%) patients in the observation-only group. In the daratumumab group, two adverse events led to death (septic shock and natural killer-cell lymphoblastic lymphoma); both were related to treatment.
INTERPRETATION


Daratumumab maintenance every 8 weeks for 2 years significantly reduced the risk of disease progression or death compared with observation only. Longer follow-up and other ongoing studies will shed further light on the optimal daratumumab-containing post-ASCT maintenance treatment strategy.
FUNDING


Janssen Research & Development, the Intergroupe Francophone du Myélome, and the Dutch-Belgian Cooperative Trial Group for Hematology Oncology.",2021,"BACKGROUND


CASSIOPEIA part 1 showed superior depth of response and significantly improved progression-free survival with daratumumab, bortezomib, thalidomide, and dexamethasone (D-VTd) versus bortezomib, thalidomide, and dexamethasone (VTd) as induction and consolidation in patients with autologous stem-cell transplant (ASCT)-eligible newly diagnosed multiple myeloma.","['patients with newly diagnosed multiple myeloma (CASSIOPEIA', 'Between May 30, 2016, and June 18, 2018', 'patients with autologous stem-cell transplant (ASCT)-eligible newly diagnosed multiple myeloma', 'Patients still on study who had a partial response or better', 'patients aged 18-65 years with newly diagnosed multiple myeloma and Eastern Cooperative Oncology Group performance status 0-2, done in 111 European academic and community practice centres', '886 patients (458 [84%] of 543 in the D-VTd group and 428 [79%] of 542 in the VTd group', 'n=442) or observation only (n=444']","['bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant', 'induction and consolidation with D-VTd or VTd', 'daratumumab maintenance', 'daratumumab, bortezomib, thalidomide, and dexamethasone (D-VTd) versus bortezomib, thalidomide, and dexamethasone (VTd']","['hypertension', 'median progression-free survival', 'neutropenia', 'Safety', 'progression-free survival', 'lymphopenia', 'Serious adverse events', 'death (septic shock and natural killer-cell lymphoblastic lymphoma', 'risk of disease progression or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0303403', 'cui_str': 'Indium-111'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517775', 'cui_str': '428'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1142155', 'cui_str': 'Natural killer-cell lymphoblastic lymphoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.446996,"BACKGROUND


CASSIOPEIA part 1 showed superior depth of response and significantly improved progression-free survival with daratumumab, bortezomib, thalidomide, and dexamethasone (D-VTd) versus bortezomib, thalidomide, and dexamethasone (VTd) as induction and consolidation in patients with autologous stem-cell transplant (ASCT)-eligible newly diagnosed multiple myeloma.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology Clinic, University Hospital Hôtel-Dieu, Nantes, France. Electronic address: philippe.moreau@chu-nantes.fr.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Hulin', 'Affiliation': 'Bordeaux University Hospital Center, Bordeaux, France.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Perrot', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Arnulf', 'Affiliation': 'Hematology and Oncology, Hôpital Saint Louis, APHP, Paris, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Belhadj', 'Affiliation': 'Hôpital Henri Mondor, Creteil, France.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': 'Tours University Hospital, Hôpital de Bretonneau, Tours, France.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Béné', 'Affiliation': 'Hematology Biology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Caillon', 'Affiliation': 'Biochemistry Laboratory, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Caillot', 'Affiliation': 'Dijon University Hospital, Hôpital du Bocage, Dijon, France.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Corre', 'Affiliation': 'Unité de Genomique du Myélome, IUC-T Oncopole, Toulouse, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Delforge', 'Affiliation': 'Department of Hematology, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dejoie', 'Affiliation': 'Biochemistry Laboratory, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Doyen', 'Affiliation': 'Université Catholique de Louvain, CHU UCL Namur, Yvoir, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Sonntag', 'Affiliation': 'University Hospital, Hôpital Hautepierre, Strasbourg, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Fontan', 'Affiliation': 'University Hospital Jean Minjoz, Besancon, France.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Mohty', 'Affiliation': 'Hematology and Cellular Therapy Department of Saint-Antoine Hospital, Sorbonne University, Paris, France.'}, {'ForeName': 'Kon-Siong', 'Initials': 'KS', 'LastName': 'Jie', 'Affiliation': 'Zuyderland MC, Sittard, Netherlands.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Karlin', 'Affiliation': 'Lyon University Hospital, Hematology Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Kuhnowski', 'Affiliation': 'Institut Curie Paris, Paris, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Lambert', 'Affiliation': 'Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'Poitiers University Hospital, CHU la Milétrie, Poitiers, France.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Macro', 'Affiliation': 'Caen University Hospital, Caen, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Orsini-Piocelle', 'Affiliation': 'Centre Hospitalier Annecy Genevois, Pringy, France.'}, {'ForeName': 'Murielle', 'Initials': 'M', 'LastName': 'Roussel', 'Affiliation': 'CHU Dupuytren, Limoges, France.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Stoppa', 'Affiliation': 'Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Wuillème', 'Affiliation': 'Hematology Biology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Broijl', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Touzeau', 'Affiliation': 'Hematology Clinic, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Tiab', 'Affiliation': 'Centre Hospitalier Départemental Vendée, La Roche sur Yon, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Marolleau', 'Affiliation': 'Hematology Clinic, Amiens University Hospital, Amiens, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Meuleman', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Marie-Christiane', 'Initials': 'MC', 'LastName': 'Vekemans', 'Affiliation': 'Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Westerman', 'Affiliation': 'Northwest Clinics, Alkmaar, Netherlands.'}, {'ForeName': 'Saskia K', 'Initials': 'SK', 'LastName': 'Klein', 'Affiliation': 'Meander Medical Centre, Amersfoort, Netherlands.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Albert Schweitzer Ziekenhuis, Dordrecht, Netherlands.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Escoffre-Barbe', 'Affiliation': 'Rennes University Hospital, Hôpital de Pontchaillou, Rennes, France.'}, {'ForeName': 'Jean-Richard', 'Initials': 'JR', 'LastName': 'Eveillard', 'Affiliation': 'Brest University Hospital, Hôpital A Morvan, Brest, France.'}, {'ForeName': 'Réda', 'Initials': 'R', 'LastName': 'Garidi', 'Affiliation': 'Saint-Quentin Hospital Center, Saint Quentin, France.'}, {'ForeName': 'Tahamtan', 'Initials': 'T', 'LastName': 'Ahmadi', 'Affiliation': 'Genmab, Princeton, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Krevvata', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'de Boer', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, Netherlands.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Vara', 'Affiliation': 'Janssen Research & Development, High Wycombe, UK.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kampfenkel', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, Netherlands.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Vanquickelberghe', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, Netherlands.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Unité de Genomique du Myélome, IUC-T Oncopole, Toulouse, France.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00428-9']
1618,34532775,Running exercise with end-expiratory breath holding up to the breaking point induces large and early fall in muscle oxygenation.,"PURPOSE


The goal of this study was to assess the effects of repeated running bouts with end-expiratory breath holding (EEBH) up to the breaking point on muscle oxygenation.
METHODS


Eight male runners participated in three randomised sessions each including two exercises on a motorised treadmill. The first exercise consisted in performing 10-12 running bouts with EEBH of maximum duration either (separate sessions) at 60% (active recovery), 80% (passive recovery) or 100% (passive recovery) of the maximal aerobic velocity (MAV). Each repetition started at the onset of EEBH and ended at its release. In the second exercise of the session, subjects replicated the same procedure but with normal breathing (NB). Arterial oxygen saturation (SpO 2 ), heart rate (HR) and the change in vastus lateralis muscle deoxy-haemoglobin/myoglobin (Δ[HHb/Mb]) and total haemoglobin/myoglobin (Δ[THb/Mb]) were continuously monitored throughout exercises.
RESULTS


On average, the EEBHs were maintained for 10.1 ± 1.1 s, 13.2 ± 1.8 s and 12.2 ± 1.7 s during exercise at 60%, 80% and 100% of MAV, respectively. In the three exercise intensities, SpO 2  (mean nadir values: 76.3 ± 2.5 vs 94.5 ± 2.5%) and HR were lower with EEBH than with NB at the end of the repetitions; whereas, the mean Δ[HHb/Mb] (12.6 ± 5.2 vs 7.7 ± 4.4 µm) and Δ[THb/Mb] (- 0.6 ± 2.3 vs 3.8 ± 2.6 µm) were, respectively, higher and lower with EEBH (p < 0.05).
CONCLUSION


This study showed that performing repeated bouts of running exercises with EEBH up to the breaking point induced a large and early drop in muscle oxygenation compared with the same exercise with NB. This phenomenon was probably the consequence of the strong arterial oxygen desaturation induced by the maximal EEBHs.",2021,"In the three exercise intensities, SpO 2  (mean nadir values: 76.3 ± 2.5 vs 94.5 ± 2.5%) and HR were lower with EEBH than with NB at the end of the repetitions; whereas, the mean Δ[HHb/Mb] (12.6 ± 5.2 vs 7.7 ± 4.4 µm) and Δ[THb/Mb] (- 0.6 ± 2.3 vs 3.8 ± 2.6 µm) were, respectively, higher and lower with EEBH (p < 0.05).
",['Eight male runners'],"['Running exercise with end-expiratory breath holding', 'maximal aerobic velocity (MAV', 'repeated running bouts with end-expiratory breath holding (EEBH']","['Arterial oxygen saturation (SpO 2 ), heart rate (HR) and the change in vastus lateralis muscle deoxy-haemoglobin/myoglobin (Δ[HHb/Mb]) and total haemoglobin/myoglobin (Δ[THb/Mb']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",8.0,0.0627679,"In the three exercise intensities, SpO 2  (mean nadir values: 76.3 ± 2.5 vs 94.5 ± 2.5%) and HR were lower with EEBH than with NB at the end of the repetitions; whereas, the mean Δ[HHb/Mb] (12.6 ± 5.2 vs 7.7 ± 4.4 µm) and Δ[THb/Mb] (- 0.6 ± 2.3 vs 3.8 ± 2.6 µm) were, respectively, higher and lower with EEBH (p < 0.05).
","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Woorons', 'Affiliation': ""Univ. Lille, Univ. Artois, Univ. Littoral Côte d'Opale, EA 7369 - URePSSS - Unité de Recherche Pluridisciplinaire Sport Santé Société, 59000, Lille, France. xavier.woorons@gmail.com.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Billaut', 'Affiliation': 'Département de Kinésiologie, Faculté de Médecine, Université Laval, Québec, QC, G1V 0S6, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lamberto', 'Affiliation': 'UFR de Santé, Médecine et Biologie Humaine, Université Paris 13, Bobigny, France.'}]",European journal of applied physiology,['10.1007/s00421-021-04813-2']
1619,34535615,Prevalence of high-risk HPV by RNA assay in home self-collected samples among underscreened people in North Carolina.,"BACKGROUND


Low-income and uninsured people with a cervix (PWC) are at highest risk of being underscreened for cervical cancer. We evaluated the prevalence of high-risk HPV (hrHPV) on home self-collected samples, as well as rates of in-clinic follow-up and risk factors associated with hrHPV positivity in this at-risk population.
METHODS


My-Body-My-Test-3 was conducted between 2016-2019 in North Carolina among individuals aged 25-64 years, overdue for cervical cancer screening, and with incomes of <250% of the U.S. Federal Poverty Level. Our analytic sample included participants randomized to the self-collection arm who returned self-collected cervico-vaginal brush samples for HPV testing (n = 329). Samples were tested for 14 hrHPV types by an HPV RNA assay and further genotyped for HPV 16 and HPV 18/45. We examined behavioral risk factors for hrHPV positivity using logistic regression and between-subjects t-tests.
RESULTS


HrHPV RNA prevalence was 16% (n = 52/329) in self-collected samples. Of the hrHPV-positive participants, 24 (46%) presented for in-clinic cervical cancer screening, compared to 56 (20%) of hrHPV-negative participants. Those with ≥2 sexual partners in the past year were twice as likely to be hrHPV positive in adjusted analyses (adjusted OR = 2.00 (95% CI: 1.03-3.88). HrHPV-positive and negative participants had similar attitudes towards screening, with the exception of hrHPV-positive participants who reported a lower perceived risk of cervical cancer than those who were hrHPV-negative (p < .05).
CONCLUSION


The hrHPV RNA prevalence was similar to findings in other underscreened PWC in the US. Efforts to reach underscreened PWC is critical for cervical cancer prevention. Future studies aimed at home self-collection should address methods of increasing clinic attendance and completion of treatment among those with HPV-positive results.",2021,"HrHPV-positive and negative participants had similar attitudes towards screening, with the exception of hrHPV-positive participants who reported a lower perceived risk of cervical cancer than those who were hrHPV-negative (p < .05).
","['Low-income and uninsured people with a cervix (PWC', 'participants randomized to the self-collection arm who returned self-collected cervico-vaginal brush samples for HPV testing (n = 329', 'My-Body-My-Test-3 was conducted between 2016-2019 in North Carolina among individuals aged 25-64 years, overdue for cervical cancer screening, and with incomes of <250% of the U.S. Federal Poverty Level', 'underscreened people in North Carolina']",[],"['risk of cervical cancer', 'prevalence of high-risk HPV (hrHPV']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205064', 'cui_str': 'Cervical'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]",,0.100982,"HrHPV-positive and negative participants had similar attitudes towards screening, with the exception of hrHPV-positive participants who reported a lower perceived risk of cervical cancer than those who were hrHPV-negative (p < .05).
","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC Lineberger Comprehensive Cancer Center, University of North Carolina Department of Health Behavior, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, NC, USA American Sexual Health Association, Research Triangle Park, NC, USA Laboratory Corporation of America Holdings, Burlington, NC, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Bukowski', 'Affiliation': ''}, {'ForeName': 'Lisa P', 'Initials': 'LP', 'LastName': 'Spees', 'Affiliation': ''}, {'ForeName': 'Stephanie B', 'Initials': 'SB', 'LastName': 'Wheeler', 'Affiliation': ''}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': ''}, {'ForeName': 'Busola', 'Initials': 'B', 'LastName': 'Sanusi', 'Affiliation': ''}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Hudgens', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Barclay', 'Affiliation': ''}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Smith', 'Affiliation': ''}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001557']
1620,34534770,Impacts of dietary self-monitoring via MyFitnessPal to undergraduate women: A qualitative study.,"The present study explored college women's perceptions of how dietary self-monitoring alters eating and body image-related cognitions and behaviors. The sample consisted of undergraduate women (N = 20), aged ≥ 18 (mean = 21.9 ± 6.6 years) from a cross-sectional qualitative study using semi-structured interviews conducted upon participants' completion of a randomized controlled trial testing the effects of dietary self-monitoring via the smartphone app, MyFitnessPal. Inductive content analysis was utilized to identify participants' perceptions of how engaging in dietary self-monitoring for one month impacted them. Participants' experiences dietary self-monitoring was highly variable, with some participants reporting increased negative feelings (n = 9), positive feelings (n = 7), or both (n = 2). Other notable findings included increases in weight and/or shape concerns (n = 10) and a number of changes in dietary intake and other behaviors. Participants indicated that dietary self-monitoring may be helpful when trying to lose weight but harmful if the behavior becomes obsessive or if the user has poor body image. Individual experiences with dietary self-monitoring varies widely, and while dietary self-monitoring may be a useful tool for some college women, use should be monitored to avoid possible harmful side effects.",2021,"Participants' experiences dietary self-monitoring was highly variable, with some participants reporting increased negative feelings (n = 9), positive feelings (n = 7), or both (n = 2).","['to undergraduate women', 'college women', ""college women's perceptions of how dietary self-monitoring alters eating and body image-related cognitions and behaviors"", ""undergraduate women (N\u202f=\u202f20), aged ≥ 18 (mean\u202f=\u202f21.9\u202f±\u202f6.6 years) from a cross-sectional qualitative study using semi-structured interviews conducted upon participants' completion""]","['dietary self-monitoring via the smartphone app, MyFitnessPal', 'dietary self-monitoring via MyFitnessPal']","['negative feelings', 'weight and/or shape concerns']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0949415', 'cui_str': 'Qualitative Research'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]",,0.0481638,"Participants' experiences dietary self-monitoring was highly variable, with some participants reporting increased negative feelings (n = 9), positive feelings (n = 7), or both (n = 2).","[{'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Hahn', 'Affiliation': 'Department of Nutritional Sciences, University of Michigan School of Public Health, United States; Division of Epidemiology & Community Health, University of Minnesota School of Public Health, United States; Department of Psychiatry & Behavioral Sciences, University of Minnesota Medical School, United States. Electronic address: hahn0203@umn.edu.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Linxwiler', 'Affiliation': 'Department of Nutritional Sciences, University of Michigan School of Public Health, United States.'}, {'ForeName': 'Tran', 'Initials': 'T', 'LastName': 'Huynh', 'Affiliation': 'Department of Nutritional Sciences, University of Michigan School of Public Health, United States.'}, {'ForeName': 'Kelsey L', 'Initials': 'KL', 'LastName': 'Rose', 'Affiliation': ""Department of Nutritional Sciences, University of Michigan School of Public Health, United States; Division of Adolescent Medicine, Boston Children's Hospital, United States.""}, {'ForeName': 'Katherine W', 'Initials': 'KW', 'LastName': 'Bauer', 'Affiliation': 'Department of Nutritional Sciences, University of Michigan School of Public Health, United States.'}, {'ForeName': 'Kendrin R', 'Initials': 'KR', 'LastName': 'Sonneville', 'Affiliation': 'Department of Nutritional Sciences, University of Michigan School of Public Health, United States.'}]",Body image,['10.1016/j.bodyim.2021.08.010']
1621,34534672,Effectiveness of inhalation technique assessment service for patients with Respimat® inhaler.,"OBJECTIVES


The objective of this study was to examine how Inhalation Technique Assessment Service (ITAS) by community pharmacies affect patients' inhalation techniques when using the Respimat® soft mist inhaler. The inhaler was simultaneously updated into a reusable inhaler. The study focused on the Respimat® inhaler because its use is known to be challenging for patients.
METHODS


The study was performed as a pre-post design in 33 community pharmacies (CPs) in Finland. Patients' inhalation technique was assessed before ITAS (baseline) and immediately after ITAS (follow-up 1). Follow-up 2 was performed when the patient came to the pharmacy for a refill (1-3 months after the baseline and the follow-up 1). A Respimat specific twenty item checklist was used to assess inhalation technique. The checklist included 1) preparation steps before the first use of the Respimat® inhaler (8 items) and 2) daily use steps of the Respimat® inhaler (12 items). After ITAS, the patients received a brief questionnaire to assess their asthma/COPD history.
RESULTS


A total of 228 patients were enrolled at the first visit (mean age 67.8 years, 61.0% female, 85.5% had previous Respimat® use experience) and 42 of them attended the follow-up 2, 1-3 months later (mean age 70.1 years, 69.0% female, 92.9% had previous Respimat® use experience. The median number of the steps performed correctly increased from 17/20 at the baseline to all the 20 steps at the follow-up 1 (p < 0.001). At the baseline, 27.6% of the patients (n = 228) performed all preparation steps correctly, while 87.3% at the follow-up 1 and 71.4% at the follow-up 2. The percentage of the patients with acceptable inhalation technique (all critical daily use steps correct) increased from 69.7% at the baseline to 93.0% at the follow-up 1 (p < 0.001). The corresponding figure at the follow-up 2 was 69.0%. At the baseline, 30.3% of patients had optimal inhalation technique (all daily use steps correct). At the follow-up 1 corresponding figure was 85.1%, and 54.8% at the follow-up 2.
CONCLUSIONS


A pharmacist-led intervention significantly improved asthma and COPD patients' inhalation technique with the Respimat® inhaler. Significant improvements were found in the daily use steps and the preparation steps before the first use.",2021,"CONCLUSIONS


A pharmacist-led intervention significantly improved asthma and COPD patients' inhalation technique with the Respimat® inhaler.","['228 patients were enrolled at the first visit (mean age 67.8 years, 61.0% female, 85.5% had previous Respimat® use experience) and 42 of them attended the follow-up 2, 1-3 months later (mean age 70.1 years, 69.0% female, 92,9% had previous Respimat® use experience', '33 community pharmacies (CPs) in Finland', 'Patients with Respimat® inhaler']","['Inhalation Technique Assessment Service', 'Inhalation Technique Assessment Service (ITAS']",['median number of the steps performed correctly'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}]","[{'cui': 'C1998547', 'cui_str': 'Inhalation technique'}, {'cui': 'C0587538', 'cui_str': 'Assessment service'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",228.0,0.0226942,"CONCLUSIONS


A pharmacist-led intervention significantly improved asthma and COPD patients' inhalation technique with the Respimat® inhaler.","[{'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Rossi', 'Affiliation': 'Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland. Electronic address: vilmamaria.rossi@hotmail.com.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Salimäki', 'Affiliation': 'Association of Finnish Pharmacies, Helsinki, Finland.'}, {'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Sandler', 'Affiliation': 'Association of Finnish Pharmacies, Helsinki, Finland.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Airaksinen', 'Affiliation': 'Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kauppi', 'Affiliation': 'Department of Pulmonary Diseases, Helsinki University Hospital, Helsinki, Finland; Department of Allergy, Skin and Allergy Hospital, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2021.102077']
1622,34536915,Evaluation of the impact of deep neuromuscular blockade on surgical conditions for laryngeal microsurgery with High Frequency Jet Ventilation. A comparison with no block during intravenous general anesthesia with topical lidocaine.,"OBJECTIVE


Laryngeal transoral surgery classically requires a neuromuscular block (NMB) to facilitate tracheal intubation and to improve surgical conditions. However, the short duration of most procedures and the potential complications of residual NMB lead to consider a no block approach. The hypothesis that intravenous anesthesia (remifentanil and propofol infusions) without NMB but including glottis topical lidocaine anesthesia would allow clinically acceptable laryngeal exposure and good surgical conditions was tested in the specific context of procedures undergone with High Frequency Jet Ventilation (HFJV).
STUDY DESIGN


A prospective randomized clinical comparison.
METHODS


66 consenting patients were planned to receive 0.6 mg·kg -1  rocuronium or saline at random. The outcome measurements included the time and conditions to complete suspended laryngoscopy, and the surgical conditions rated by the surgeon. Any vocal cord movement or coughing was recorded. Data were compared using a Wilcoxon rank-sum test for numerical variables and chi-square test for categorical ones. Treatment failure was defined as an impossible laryngoscopy or a grade 4 surgical field occurring at any time during surgery and was compared to its null theoretical value by a general z-test. An interim analysis after completion of 50% patients was performed using Pocock boundaries at 0.0294 significance levels.
RESULTS


A significant failure rate occurred in the non paralysed group (27%, p < 0.001). No coughing and no vocal cords movement occurred in the NMB group. Poorer surgical conditions were obtained without NMB (p = 0.011).
CONCLUSION


Inducing a deep NMB ensured improved conditions during direct laryngeal microsurgery with HFJV.",2021,"A significant failure rate occurred in the non paralysed group (27%, p < 0.001).","['laryngeal microsurgery with High Frequency Jet Ventilation', 'consenting patients', '66']","['rocuronium or saline', 'Laryngeal transoral surgery classically requires a neuromuscular block (NMB', 'NMB', 'lidocaine anesthesia', 'topical lidocaine', 'intravenous anesthesia (remifentanil']","['time and conditions to complete suspended laryngoscopy, and the surgical conditions rated by the surgeon', 'failure rate', 'No coughing and no vocal cords movement', 'vocal cord movement or coughing', 'Poorer surgical conditions']","[{'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C0019540', 'cui_str': 'High frequency jet ventilation'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",66.0,0.07105,"A significant failure rate occurred in the non paralysed group (27%, p < 0.001).","[{'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Putz', 'Affiliation': 'Université catholique de Louvain, CHU UCL Namur, Department of Anesthesiology, Avenue Dr G Thérasse 1, 5530 Yvoir, Belgium. Electronic address: laurie.putz@uclouvain.be.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Lovqvist', 'Affiliation': 'Université catholique de Louvain, CHU UCL Namur, Department of Anesthesiology, Avenue Dr G Thérasse 1, 5530 Yvoir, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Bachy', 'Affiliation': 'Université catholique de Louvain, CHU UCL Namur, Department of Oto-rhino-laryngology, Avenue Dr G Thérasse 1, 5530 Yvoir, Belgium.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Van der Vorst', 'Affiliation': 'Université catholique de Louvain, CHU UCL Namur, Department of Oto-rhino-laryngology, Avenue Dr G Thérasse 1, 5530 Yvoir, Belgium.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Jamart', 'Affiliation': 'Université catholique de Louvain, CHU UCL Namur, Scientific Support Unit, Avenue Dr G Thérasse 1, 5530 Yvoir, Belgium.'}, {'ForeName': 'Philippe E', 'Initials': 'PE', 'LastName': 'Dubois', 'Affiliation': 'Université catholique de Louvain, CHU UCL Namur, Department of Anesthesiology, Avenue Dr G Thérasse 1, 5530 Yvoir, Belgium.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.103187']
1623,34529768,Long-term quality of life of patients with acute promyelocytic leukemia treated with arsenic trioxide vs chemotherapy.,"The main objective of this study was to compare the long-term health-related quality of life of patients with acute promyelocytic leukemia (APL) treated with all-trans retinoic acid (ATRA) plus arsenic trioxide (ATO) vs ATRA plus standard chemotherapy. Patients previously enrolled in the randomized controlled trial APL0406 were considered eligible for this follow-up study. The following patient-reported outcome measures were used: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30), the EORTC Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20), and the Short Form Health Survey 36 (SF-36). The prevalence of late comorbidities and health problems was also assessed. The clinical significance of differences was evaluated based on predefined thresholds. A total of 161 of 232 potentially eligible patients were analyzed, of whom 83 were treated with ATRA-ATO and 78 were treated with ATRA chemotherapy. The median time since diagnosis of the study sample was 8 years. The 2 largest clinically meaningful differences in the EORTC QLQ-C30 were observed for role functioning (Δ = 8.4; 95% confidence interval [CI], 0.5 to 16.3) and dyspnea (Δ = -8.5; 95% CI, -16.4 to -0.7), favoring patients treated with ATRA-ATO. With regard to the SF-36 results, a clinically relevant better physical component score (Δ = 4.6; 95% CI, 1.3 to 7.8) was observed in patients treated with ATRA-ATO, but this was not the case for the mental component score. The 2 groups showed similar profiles in the scores of the EORTC QLQ-CIPN20 scales and in the prevalence of late comorbidities. Overall, our findings suggest that the greater and more sustained antileukemic efficacy of ATRA-ATO is also associated with better long-term patient-reported outcomes than ATRA chemotherapy. This study was registered at www.clinicaltrials.gov as #NCT03096496.",2021,The two groups showed similar profiles in the scores of the EORTC QLQ-CIPN20 scales and in the prevalence of late comorbidities.,"['Acute Promyelocytic Leukemia Patients Treated with', 'One hundred sixty-one out of 232 potentially eligible patients were analyzed, of whom 83 were treated with ATRA-ATO and 78 were treated with', 'patients with acute promyelocytic leukemia (APL) treated with']","['ATRA-chemotherapy', 'Arsenic Trioxide versus Chemotherapy', 'all-trans retinoic acid (ATRA) plus arsenic trioxide (ATO) versus ATRA plus standard chemotherapy']","['prevalence of late comorbidities and health problems', 'dyspnea', 'physical component score', 'scores of the EORTC QLQ-CIPN20 scales', 'EORTC QLQ-C30, the EORTC QLQ-CIPN20 and the SF-36', 'median time since diagnosis', 'EORTC QLQ-C30']","[{'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0052416', 'cui_str': 'arsenic trioxide'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0052416', 'cui_str': 'arsenic trioxide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",232.0,0.0994956,The two groups showed similar profiles in the scores of the EORTC QLQ-CIPN20 scales and in the prevalence of late comorbidities.,"[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Efficace', 'Affiliation': 'Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Platzbecker', 'Affiliation': 'Medical Clinic and Polyclinic I, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Breccia', 'Affiliation': 'Hematology, Department of Translational and Precision Medicine, University Sapienza Rome, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cottone', 'Affiliation': 'Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Carluccio', 'Affiliation': 'Hematology and Bone Marrow Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.'}, {'ForeName': 'Prassede', 'Initials': 'P', 'LastName': 'Salutari', 'Affiliation': 'Haematology, Pescara Hospital, Pescara, Italy.'}, {'ForeName': 'Eros', 'Initials': 'E', 'LastName': 'Di Bona', 'Affiliation': 'Division of Hematology, San Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Borlenghi', 'Affiliation': 'Hematology, ASST-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Autore', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Levato', 'Affiliation': 'Department of Hematology-Oncology, Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy.'}, {'ForeName': 'Olimpia', 'Initials': 'O', 'LastName': 'Finizio', 'Affiliation': 'Division of Hematology, Cardarelli General Hospital, Naples, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Mancini', 'Affiliation': 'Department of Hematology and Oncology, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': ""D'Ardia"", 'Affiliation': 'Division of Hematology, Department of Oncology, Presidio Molinette, AOU Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Melillo', 'Affiliation': 'Division of Hematology, IRCCS ""Casa Sollievo della Sofferenza"" Hospital, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Fumagalli', 'Affiliation': 'Hematology, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiedler', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Germana', 'Initials': 'G', 'LastName': 'Beltrami', 'Affiliation': 'Hematology and Bone Marrow Transplantation Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Nicola Stefano', 'Initials': 'NS', 'LastName': 'Fracchiolla', 'Affiliation': ""Hematology, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Bernardi', 'Affiliation': 'Hematology and Bone Marrow Transplantation Unit, San Raffaele Scientific, Milano, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Fazi', 'Affiliation': 'Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.'}, {'ForeName': 'Ombretta', 'Initials': 'O', 'LastName': 'Annibali', 'Affiliation': 'Hematology and Stem Cell Transplantation Unit, Campus Bio-Medico University, Roma, Italy.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Bonn, Bonn, Germany; and.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Voso', 'Affiliation': 'Department of Biomedicine and Prevention, Università di Roma ""Tor Vergata"", Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Vignetti', 'Affiliation': 'Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.'}]",Blood advances,['10.1182/bloodadvances.2021004649']
1624,34560612,Motor competence in fundamental motor skills and sport skill learning: Testing the proficiency barrier hypothesis.,"We investigated whether motor competence in fundamental motor skills influences sports motor skill learning. Motor competence in fundamental motor skills related to the overhead volleyball serve (i.e., throwing and volleying) was evaluated in 38 children (aged 9-10 yrs) and participants were divided into lower and higher motor competence groups. The groups practiced the volleyball serve under random or constant-random conditions during an acquisition phase and then assessed in pre-test, intermediate, and retention tests. A three-way repeated-measures ANOVA showed performance improvement from pre-test to retention test only for high motor competence groups in fundamental motor skills. Initial competence in fundamental motor skills influences sport skills learning and demonstrates a potential proficiency barrier to learning complex-sports motor skills.",2021,A three-way repeated-measures ANOVA showed performance improvement from pre-test to retention test only for high motor competence groups in fundamental motor skills.,['38 children (aged 9-10\xa0yrs) and participants were divided into lower and higher motor competence groups'],['sport skill learning'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",[],38.0,0.0652788,A three-way repeated-measures ANOVA showed performance improvement from pre-test to retention test only for high motor competence groups in fundamental motor skills.,"[{'ForeName': 'Cicero L A', 'Initials': 'CLA', 'LastName': 'Costa', 'Affiliation': 'Department of Physical Education and Sport, Instituto Federal de Educação, Ciência e Tecnologia do Ceará, Limoeiro do Norte, Brazil.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Cattuzzo', 'Affiliation': 'Higher School of Physical Education, Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Stodden', 'Affiliation': 'Department of Physical Education, University of South Carolina, Columbia, USA.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Ugrinowitsch', 'Affiliation': 'School of Physical Education, Physiotherapy and Occupational Therapy, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil. Electronic address: herbertu@ufmg.br.'}]",Human movement science,['10.1016/j.humov.2021.102877']
1625,34563097,"Effectiveness of a synthetic human recombinant epidermal growth factor in diabetic patients wound healing: Pilot, double-blind, randomized clinical controlled trial.","To investigate whether the addition of human recombinant epidermal growth factor (h-EGF) to 2% carboxymethyl cellulose gel is more effective in diabetic wound healing than standard treatment, a pilot, double-blind, randomized and controlled clinical trial with therapeutic intervention was performed at a university hospital. The sample consisted of 25 patients (14 in the intervention group that used rh-EGF and 11 in the control group that used 2% carboxymethyl cellulose gel). Data were tabulated in SPSS and analysed by intention to treat, without loss or exclusion of participants. Twenty-five subjects participated with a mean age of 60.6 years, a predominance of males in both groups and 100% prevalence of type-2 diabetes. Within 12 weeks, complete wound healing occurred in three ulcers in the intervention group versus one ulcer in the control group. The percent reduction in the wound area was significantly higher in the intervention group than in the control group (p = 0.049). Concerning the types of tissue, an increase in granulation and epithelial tissue and a reduction in exudate levels were observed in both groups. Decreased slough occurred only in the intervention group. No participant experienced serious or local adverse events during the study period. This study shows that h-EGF is effective, with a statistically significant reduction in wound area, improvement of tissue quality, and safe treatment of chronic wounds. In addition, this study demonstrated that blinding of participants during research using h-EGF is feasible.",2021,"Concerning the types of tissue, an increase in granulation and epithelial tissue and a reduction in exudate levels were observed in both groups.","['diabetic patients wound healing', 'Twenty-five subjects participated with a mean age of 60.6\u2009years, a predominance of males in both groups and 100% prevalence of type-2 diabetes']","['human recombinant epidermal growth factor (h-EGF) to 2% carboxymethyl cellulose gel', 'synthetic human recombinant epidermal growth factor', 'rh-EGF and 11 in the control group that used 2% carboxymethyl cellulose gel']","['Decreased slough', 'complete wound healing', 'serious or local adverse events', 'granulation and epithelial tissue and a reduction in exudate levels', 'tissue quality', 'wound area']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0027544', 'cui_str': 'Necrotic debris'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",25.0,0.0176815,"Concerning the types of tissue, an increase in granulation and epithelial tissue and a reduction in exudate levels were observed in both groups.","[{'ForeName': 'Bianca Campos', 'Initials': 'BC', 'LastName': 'Oliveira', 'Affiliation': 'Doctoral student in Health Care Sciences, Federal Fluminense University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Beatriz Guitton Renaud Baptista', 'Initials': 'BGRB', 'LastName': 'de Oliveira', 'Affiliation': 'Full Professor at Universidade Federal Fluminense, Coordinator of the Graduate Program in Health Care Sciences, Federal Fluminense University, Health Area Coordinator - FAPERJ, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Deutsch', 'Affiliation': 'PhD in Sciences Applied to Health Products, Federal Fluminense University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fernanda Soares', 'Initials': 'FS', 'LastName': 'Pessanha', 'Affiliation': 'PhD in Health Care Sciences, Federal Fluminense University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Selma Rodrigues', 'Initials': 'SR', 'LastName': 'de Castilho', 'Affiliation': 'Full Professor at Federal Fluminense University, Director of the College of Pharmacy, Federal Fluminense University, Niterói, Rio de Janeiro, Brazil.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12969']
1626,34561221,"ConCerv: a prospective trial of conservative surgery for low-risk early stage cervical cancer, by Schmeler  et al .",,2021,,[],['conservative surgery'],[],[],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],,0.0546229,,"[{'ForeName': 'Nadeem R', 'Initials': 'NR', 'LastName': 'Abu-Rustum', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA abu-rusn@mskcc.org.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2021-003008']
1627,34533039,Glutathione Infusion Before and 3 Days After Primary Angioplasty Blunts Ongoing NOX2-Mediated Inflammatory Response.,"Background Glutathione is a water-soluble tripeptide with a potent oxidant scavenging activity. We hypothesized that glutathione administration immediately before and after primary angioplasty (primary percutaneous coronary intervention) could be effective in modulating immune cell activation, thereby preventing infarct expansion. Methods and Results One hundred consecutive patients with ST-segment-elevation myocardial infarction, scheduled to undergo primary percutaneous coronary intervention were randomly assigned before the intervention to receive an infusion of glutathione (2500 mg/25 mL over 10 minutes), followed by drug administration at the same doses at 24, 48, and 72 hours elapsing time or placebo. Total leukocytes, NOX2 (nicotinamide adenine dinucleotide phosphate oxidase 2) activation, NO bioavailability, cTpT (serum cardiac troponin T), hsCRP (high-sensitivity C-reactive protein), and TNF-α (tumor necrosis factor α) levels were measured. Left ventricular size and function were assessed within 120 minutes, 5 days, and 6 months from percutaneous coronary intervention. Following reperfusion, a significant reduction of neutrophil to lymphocyte ratio ( P <0.0001), hsCRP generation ( P <0.0001), NOX2 activation ( P <0.0001), TNF-α levels ( P <0.001), and cTpT release ( P <0.0001) were found in the glutathione group compared with placebo. In treated patients, blunted inflammatory response was linked to better left ventricular size and function at follow-up ( r =0.78,  P <0.005). Conclusions Early and prolonged glutathione infusion seems able to protect vital myocardial components and endothelial cell function against harmful pro-oxidant and inflammatory environments, thus preventing maladaptive cardiac repair and left ventricular adverse remodeling. Registration URL: https://www.clinicaltrialsregister.eu; Unique identifier: 2014-004486-25.",2021,"Following reperfusion, a significant reduction of neutrophil to lymphocyte ratio ( P <0.0001), hsCRP generation ( P <0.0001), NOX2 activation ( P <0.0001), TNF-α levels ( P <0.001), and cTpT release ( P <0.0001) were found in the glutathione group compared with placebo.","['One hundred consecutive patients with ST-segment-elevation myocardial infarction, scheduled to undergo primary percutaneous coronary intervention']","[' Glutathione', 'Glutathione Infusion', 'glutathione', 'placebo', 'infusion of glutathione']","['Total leukocytes, NOX2 (nicotinamide adenine dinucleotide phosphate oxidase 2) activation, NO bioavailability, cTpT', 'cTpT release', 'hsCRP generation', 'serum cardiac troponin T), hsCRP (high-sensitivity C-reactive protein), and TNF-α (tumor necrosis factor α) levels', 'Left ventricular size and function', 'blunted inflammatory response', 'neutrophil to lymphocyte ratio', 'NOX2-Mediated Inflammatory Response', 'TNF-α levels', 'NOX2 activation']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027303', 'cui_str': 'Nicotinamide adenine dinucleotide phosphate'}, {'cui': 'C0242417', 'cui_str': 'Oxidase'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]",100.0,0.103276,"Following reperfusion, a significant reduction of neutrophil to lymphocyte ratio ( P <0.0001), hsCRP generation ( P <0.0001), NOX2 activation ( P <0.0001), TNF-α levels ( P <0.001), and cTpT release ( P <0.0001) were found in the glutathione group compared with placebo.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Tanzilli', 'Affiliation': 'Department of Clinical, Internal Medicine, Anesthesiology, and Cardiovascular Sciences Sapienza University of Rome Rome Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Arrivi', 'Affiliation': 'Department of Cardiology Interventional Cardiology Unit, ""Santa Maria"" Hospital Terni Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Placanica', 'Affiliation': 'Department of Cardiology ""San Giovanni Evangelista"" Hospital Tivoli Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Viceconte', 'Affiliation': 'Department of Clinical, Internal Medicine, Anesthesiology, and Cardiovascular Sciences Sapienza University of Rome Rome Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Cammisotto', 'Affiliation': 'Department of General Surgery and Surgical Specialty Paride Stefanini Sapienza University of Rome Rome Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Nocella', 'Affiliation': 'Department of Clinical, Internal Medicine, Anesthesiology, and Cardiovascular Sciences Sapienza University of Rome Rome Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Barillà', 'Affiliation': 'Department of Clinical, Internal Medicine, Anesthesiology, and Cardiovascular Sciences Sapienza University of Rome Rome Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Torromeo', 'Affiliation': 'Department of Clinical, Internal Medicine, Anesthesiology, and Cardiovascular Sciences Sapienza University of Rome Rome Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Pucci', 'Affiliation': 'Internal Medicine Unit, ""Santa Maria"" Hospital Terni Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Acconcia', 'Affiliation': 'Department of Clinical, Internal Medicine, Anesthesiology, and Cardiovascular Sciences Sapienza University of Rome Rome Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Granatelli', 'Affiliation': 'Department of Cardiology ""San Giovanni Evangelista"" Hospital Tivoli Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Basili', 'Affiliation': 'Department of Translational and Precision Medicine SapienzaUniversity of Rome Rome Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Dominici', 'Affiliation': 'Department of Cardiology Interventional Cardiology Unit, ""Santa Maria"" Hospital Terni Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Gaudio', 'Affiliation': 'Department of Clinical, Internal Medicine, Anesthesiology, and Cardiovascular Sciences Sapienza University of Rome Rome Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carnevale', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies Sapienza University Latina Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Mangieri', 'Affiliation': 'Department of Clinical, Internal Medicine, Anesthesiology, and Cardiovascular Sciences Sapienza University of Rome Rome Italy.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.020560']
1628,34534371,Community sharing: Contextualizing Western research notions of contamination within an Indigenous research paradigm.,"Báa nnilah is a chronic illness self-management program designed by and for the Apsáalooke (Crow) community. Arising from a collaboration between an Indigenous nonprofit organization and a university-based research team, Báa nnilah's development, implementation, and evaluation have been influenced by both Indigenous and Western research paradigms (WRPs). Báa nnilah was evaluated using a randomized wait-list control group design. In a WRP, contamination, or intervention information shared by the intervention group with the control group, is actively discouraged as it makes ascertaining causality difficult, if not impossible. This approach is not consonant with Apsáalooke cultural values that include the encouragement of sharing helpful information with others, supporting an Indigenous research paradigm's (IRP) goal of benefiting the community. The purpose of this paper is to address contamination and sharing as an area of tension between WRP and IRP. We describe how the concepts of contamination and sharing within Báa nnilah's implementation and evaluation are interpreted differently when viewed from these contrasting paradigms, and set forth a call for greater exploration of Indigenous research approaches for developing, implementing, and evaluating intervention programs in Indigenous communities. (Improving Chronic Illness Management with the Apsáalooke Nation: The Báa nnilah Project.: NCT03036189), ClinicalTrials. gov: NCT03036189).",2021,"We describe how the concepts of contamination and sharing within Báa nnilah's implementation and evaluation are interpreted differently when viewed from these contrasting paradigms, and set forth a call for greater exploration of Indigenous research approaches for developing, implementing, and evaluating intervention programs in Indigenous communities.",['Community sharing'],[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}]",[],[],,0.0148074,"We describe how the concepts of contamination and sharing within Báa nnilah's implementation and evaluation are interpreted differently when viewed from these contrasting paradigms, and set forth a call for greater exploration of Indigenous research approaches for developing, implementing, and evaluating intervention programs in Indigenous communities.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Family Life and Human Development, Southern Utah University, Cedar City, Utah, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'Health and Human Development, Montana State University, Bozeman, Montana, USA.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Milne-Price', 'Affiliation': 'Contra Costa Health Services, Contra Costa Family Medicine Residency, University of Washington School of Medicine, Martinez, California, USA.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'McCormick', 'Affiliation': 'Executive Director of Messengers for Health, Messengers for Health, Crow Agency, Montana, USA.'}, {'ForeName': 'Du', 'Initials': 'D', 'LastName': 'Feng', 'Affiliation': 'Department of Nursing, University of Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Inouye', 'Affiliation': 'John Burns School of Medicine, University of Hawaii, Honolulu, Hawaii, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schure', 'Affiliation': 'Health and Human Development, Montana State University, Bozeman, Montana, USA.'}, {'ForeName': 'Dottie', 'Initials': 'D', 'LastName': 'Castille', 'Affiliation': 'National Institute on Minority Health and Health Disparities, Division of Community Health and Population Sciences, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Rae B', 'Initials': 'RB', 'LastName': 'Howe', 'Affiliation': 'Executive Director of Messengers for Health, Messengers for Health, Crow Agency, Montana, USA.'}, {'ForeName': 'Mikayla', 'Initials': 'M', 'LastName': 'Pitts', 'Affiliation': 'Health and Human Development, Montana State University, Bozeman, Montana, USA.'}, {'ForeName': 'Shannen', 'Initials': 'S', 'LastName': 'Keene', 'Affiliation': 'Division of the Seattle Indian Health Board, Urban Indian Health Institute, Seattle, Washington, USA.'}, {'ForeName': 'Lorenda', 'Initials': 'L', 'LastName': 'Belone', 'Affiliation': 'Health Sciences Center: Center for Participatory Research, University of New Mexico, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wallerstein', 'Affiliation': 'Health Sciences Center: Center for Participatory Research, University of New Mexico, Albuquerque, New Mexico, USA.'}]",American journal of community psychology,['10.1002/ajcp.12552']
1629,34536693,A comparison of young children's spatiotemporal gait measures in three common types of footwear with different sole hardness.,"BACKGROUND


It is unknown what the impact of sole hardness is on young children's gait. Yet, this feature is commonly marketed as having differing benefits for young children's walking and development.
RESEARCH QUESTION


What are the differences in spatiotemporal measures of gait during walking and running in three common types of young children's footwear with a soft sole, compared to a hard sole?
METHODS


The study used a quasi-experimental design, with the condition order randomised using a Latin square sequence. Forty-seven children were recruited (aged 2-4 years). Participants walked or ran the length of a GAITRite mat in a randomized order in a soft (Shore 48-53) or hard soled (Shore 60-65) sneaker, boot and sandal condition. Linear regression analyses were used to investigate the difference between footwear for the different gait parameters including velocity, cadence, step time, swing percentage, stance percentage, double support time and the toe in/out angle.
RESULTS


Children walked with a shorter stride length in the hard-soled sandals compared to the soft- soled sandals (p < 0.05). There were no other differences in spatiotemporal variables in the soft versus hard soled sandals during walking or running (p > 0.05). There were no differences in any spatiotemporal gait variables during walking or running in soft versus hard- soled runners and no differences in walking or running in soft versus hard-soled boots (p > 0.05).
SIGNIFICANCE


There were few differences in spatiotemporal parameters between soft and hard-soled footwear in both walking and running in three different types of footwear. This may be a positive finding for footwear designers and manufacturers, as a harder sole appeared to have limited impact on spatiotemporal gait parameters.",2021,"There were no differences in any spatiotemporal gait variables during walking or running in soft versus hard- soled runners and no differences in walking or running in soft versus hard-soled boots (p > 0.05).
","['Forty-seven children were recruited (aged 2-4 years', ""young children's"", 'Participants walked or ran the length of a GAITRite mat in a randomized order in a soft (Shore 48-53) or hard soled (Shore 60-65) sneaker, boot and sandal condition', ""young children's gait""]",[],"['spatiotemporal gait variables', 'spatiotemporal variables', 'walking or running in soft versus hard-soled boots', 'spatiotemporal gait measures', 'shorter stride length', 'velocity, cadence, step time, swing percentage, stance percentage, double support time and the toe in/out angle']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0453964', 'cui_str': 'Sandals'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",[],"[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0231791', 'cui_str': 'Toeing-in'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",47.0,0.0507853,"There were no differences in any spatiotemporal gait variables during walking or running in soft versus hard- soled runners and no differences in walking or running in soft versus hard-soled boots (p > 0.05).
","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Cranage', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia; Peninsula Health, Melbourne, Victoria, Australia. Electronic address: simone.cranage@monash.edu.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Perraton', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kelly-Ann', 'Initials': 'KA', 'LastName': 'Bowles', 'Affiliation': 'Department of Paramedicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Cylie', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia; Peninsula Health, Melbourne, Victoria, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2021.09.165']
1630,34536606,Effect of a novel laser-initiated photoacoustic activation of a solvent or sodium hypochlorite in the removal of filling remnants after retreatment of curved root canals.,"BACKGROUND


This study aimed to evaluate the effect of Er:YAG laser-initiated shockwave-enhanced emission of photoacoustic streaming (SWEEPS®) and passive ultrasonic irrigation (PUI) combining thymol-based solvent or sodium hypochlorite (NaOCl) in the removal of filling remnants from curved canals.
METHODS


Forty-eight curved root canals were instrumented and filled with an epoxy-resin-based sealer and gutta-percha. The canals were retreated with a Wave One Gold primary file (tip size 25; variable taper) and sodium hypochlorite (NaOCl). After the retreatment, the samples were randomly divided into four groups according to the additional irrigation protocol: PUI/NaOCl, PUI/solvent, SWEEPS®/NaOCl or SWEEPS®/solvent. The volume of filling material in root canal was measured after root canal filling, after mechanical retreatment, after final irrigation protocol and after additional irrigation protocol, using micro-CT. The results were analyzed using Kruskal-Wallis test with the post-hoc Mann-Whitney U test and Wilcoxon test (α=0.05).
RESULTS


In the PUI group, irrigation with the solvent or NaOCl resulted in similar filling reduction (p = 0.224). In the SWEEPS® group, irrigation with NaOCl resulted in a significantly greater filling reduction compared to the solvent (p = 0.021). The SWEEPS®/NaOCl group was more effective than the PUI/NaOCl group (p = 0.008). No significant differences were found between PUI/solvent and SWEEPS® groups (p>0.05) and PUI/NaOCl and SWEEPS®/solvent group (p>0.05).
CONCLUSION


Although all tested protocols improved the removal of filling remnants from curved root canal, the SWEEPS® was more successful than PUI when NaOCl was used. Both tested techniques showed similar efficacy when in combination with the solvent.",2021,"Although all tested protocols improved the removal of filling remnants from curved root canal, the SWEEPS® was more successful than PUI when NaOCl was used.","['after retreatment of curved root canals', 'Forty-eight curved root canals']","['sodium hypochlorite (NaOCl', 'novel laser-initiated photoacoustic activation of a solvent or sodium hypochlorite', 'additional irrigation protocol: PUI/NaOCl, PUI/solvent, SWEEPS®/NaOCl or SWEEPS®/solvent', 'epoxy-resin-based sealer and gutta-percha', 'Er:YAG laser-initiated shockwave-enhanced emission of photoacoustic streaming (SWEEPS®) and passive ultrasonic irrigation (PUI) combining thymol-based solvent or sodium hypochlorite (NaOCl']","['removal of filling remnants', 'filling reduction', 'volume of filling material in root canal']","[{'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0037638', 'cui_str': 'Solvent'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0014631', 'cui_str': 'Epoxy resin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040096', 'cui_str': 'Thymol'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0440137', 'cui_str': 'Filling material'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}]",,0.0371987,"Although all tested protocols improved the removal of filling remnants from curved root canal, the SWEEPS® was more successful than PUI when NaOCl was used.","[{'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Bago', 'Affiliation': 'Department of Endodontics and Restorative Dentistry, School of Dental Medicine, University of Zagreb, Croatia. Electronic address: bago@sfzg.hr.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Plotino', 'Affiliation': 'Private Practice, Grande Plotino & Torsello - Studio di Odontoiatria, Via Calabria 25, Rome, Italy.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Katić', 'Affiliation': 'Department of Quality - National Laboratory for Length, Faculty of Mechanical Engineering and Naval Architecture, University of Zagreb, Croatia.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Ferenac', 'Affiliation': 'Student of the 5th year of the School of Dental Medicine University of Zagreb, Croatia.'}, {'ForeName': 'Gabrijela Kapetanović', 'Initials': 'GK', 'LastName': 'Petričević', 'Affiliation': 'Department of Endodontics and Restorative Dentistry, School of Dental Medicine, University of Zagreb, Croatia.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Gabrić', 'Affiliation': 'Department of Oral Surgery, School of Dental Medicine University of Zagreb, Croatia.'}, {'ForeName': 'Ivica', 'Initials': 'I', 'LastName': 'Anić', 'Affiliation': 'Department of Endodontics and Restorative Dentistry, School of Dental Medicine, University of Zagreb, Croatia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102535']
1631,34530196,Covid-19 given opportunity to use ultrasound in the plaster room to continue secondary fracture prevention care: A retrospective Fracture Liaison Service study.,"INTRODUCTION


Fracture Liaison Service (FLS) managed secondary fracture prevention services have been hampered during the COVID-19 pandemic. A challenging opportunity is to use pulse-echo ultrasound (P-EU) in the plaster room. The study had two objectives: can P-EU help our decision to justly avoid DXA/VFA scans in plaster treated women (50-70 years) after fracture and whether its use can encourage or nudge all plaster treated patients (>50 years) who need DXA/VFA scans.
PATIENTS AND METHODS


1307 patients (cohort: pre-COVID-19) and 1056 patients (cohort: peri-COVID-19), each of them ≥ 50 years after recent fracture, were studied. Only in women aged 50-70 years, we used a P-EU decision threshold (DI) >= 0.896 g/cm 2  to rule out further analysis by means of DXA/VFA. All other plaster patients received P-EU as part of patient information. Peri-Covid-19, all performed DXA/VFA scans were counted until three months post-study closure. By then each patient still waiting for a DXA/VFA had received a scan.
RESULTS


Peri-COVID-19, 69 out of 191 plaster-treated women aged 50-70 years were ruled out (36%), for plaster and not in-plaster treated women aged 50-70 years, it was 27%. Comparing all peri-to pre-COVID-19 plaster-treated women and men, a significant P-EU nudging effect was found (difference in proportions: 8.8%) P = .001.
CONCLUSION


The combination of patient information and P-EU in the plaster room is effective to reduce DXA/VFA scans and allow extra patients to undergo DXA/VFA. After all, more than a quarter of 50-70 years old women in plaster did not need to be scanned.",2021,The combination of patient information and P-EU in the plaster room is effective to reduce DXA/VFA scans and allow extra patients to undergo DXA/VFA.,"['women aged 50-70 years', 'plaster treated women (50-70 years) after fracture and whether its use can encourage or nudge all plaster treated patients (>50 years) who need DXA/VFA scans', '1307 patients (cohort: pre-COVID-19) and 1056 patients (cohort: peri-COVID-19), each of them\xa0≥\xa050 years after recent fracture, were studied', '69 out of 191 plaster-treated women aged 50-70 years were ruled out (36%), for plaster and not in-plaster treated women aged 50-70 years, it was 27']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",[],[],1307.0,0.0417516,The combination of patient information and P-EU in the plaster room is effective to reduce DXA/VFA scans and allow extra patients to undergo DXA/VFA.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van den Berg', 'Affiliation': 'Dept. of Orthopedics and Surgery, Fracture Liaison Service, Reinier de Graaf Gasthuis, Delft, the Netherlands. Electronic address: p.vandenberg@rdgg.nl.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'van Leerdam', 'Affiliation': 'Bare Statistics, the Netherlands. Electronic address: http://www.barestatistics.nl.'}, {'ForeName': 'Dave H', 'Initials': 'DH', 'LastName': 'Schweitzer', 'Affiliation': 'Dept. of Internal Medicine and Endocrinology, Reinier the Graaf Gasthuis, Delft, the Netherlands.'}]",International journal of orthopaedic and trauma nursing,['10.1016/j.ijotn.2021.100899']
1632,34542671,Contralateral strength training attenuates muscle performance loss following anterior cruciate ligament (ACL) reconstruction: a randomised-controlled trial.,"PURPOSE


To investigate the effects of cross-education (CE) exercise on strength and performance at 10 and 24 weeks post anterior cruciate ligament (ACL) surgery.
METHODS


Design: randomised controlled trial. N = 44 ACL-reconstruction patients, randomly-allocated into: CE: strength training of the non-operative limb, or CON: sham exercise of upper limb stretching. Each patient underwent standardised ACL rehabilitation, plus 8 weeks of thrice weekly CE or CON, commencing at 2 weeks post surgery. The primary outcome was quadriceps peak force (QPF) of the ACL-reconstructed limb at 10 weeks post surgery. Secondary measures were hamstrings peak force (HPF), rate of force development (RFD) and International Knee Documentation Committee score (IKDC) at 10 and 24 weeks; QPF and hop for distance (HOP) at 24 weeks post surgery.
RESULTS


CE significantly attenuated the decline in QPF of the ACL-reconstructed limb at 10 weeks compared to CON (16.6% decrease vs. 32.0%, respectively); that advantage was not retained at 24 weeks. A training effect was observed in the trained limb for HPF and QPF, which was retained at 24 weeks. No significant differences were observed for IKDC, HOP, RFD, or HPF of the reconstructed limb. Inter-limb symmetry (ILS) ranged from 0.78 to 0.89 and was not significantly different between groups.
CONCLUSION


High-intensity CE strength training attenuated the post-operative decline in QPF and should be considered in early-phase ACL rehabilitation. ILS data showed good symmetry, but it masked significantly inferior performance between groups and should be used with caution.
TRIAL REGISTRATION NUMBER


NCT02722876.",2021,"Inter-limb symmetry (ILS) ranged from 0.78 to 0.89 and was not significantly different between groups.
","['at 10 and 24\xa0weeks post anterior cruciate ligament (ACL) surgery', 'anterior cruciate ligament (ACL) reconstruction', 'N\u2009=\u200944 ACL-reconstruction patients']","['standardised ACL rehabilitation, plus 8\xa0weeks of thrice weekly CE or CON', 'cross-education (CE) exercise', 'CE: strength training of the non-operative limb, or CON: sham exercise of upper limb stretching', 'High-intensity CE strength training', 'Contralateral strength training']","['strength and performance', 'hamstrings peak force (HPF), rate of force development (RFD) and International Knee Documentation Committee score (IKDC', 'quadriceps peak force (QPF) of the ACL-reconstructed limb', 'QPF of the ACL-reconstructed limb', 'IKDC, HOP, RFD, or HPF of the reconstructed limb']","[{'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0556819', 'cui_str': 'Upper limb stretching'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}]","[{'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.0691239,"Inter-limb symmetry (ILS) ranged from 0.78 to 0.89 and was not significantly different between groups.
","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Minshull', 'Affiliation': 'Research Department, RJAH Orthopaedic Hospital NHS Foundation Trust, Oswestry, SY10 7AG, UK. minshullc@hotmail.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gallacher', 'Affiliation': 'Research Department, RJAH Orthopaedic Hospital NHS Foundation Trust, Oswestry, SY10 7AG, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Roberts', 'Affiliation': 'Research Department, RJAH Orthopaedic Hospital NHS Foundation Trust, Oswestry, SY10 7AG, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Barnett', 'Affiliation': 'Research Department, RJAH Orthopaedic Hospital NHS Foundation Trust, Oswestry, SY10 7AG, UK.'}, {'ForeName': 'Jan Herman', 'Initials': 'JH', 'LastName': 'Kuiper', 'Affiliation': 'Research Department, RJAH Orthopaedic Hospital NHS Foundation Trust, Oswestry, SY10 7AG, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': 'Research Department, RJAH Orthopaedic Hospital NHS Foundation Trust, Oswestry, SY10 7AG, UK.'}]",European journal of applied physiology,['10.1007/s00421-021-04812-3']
1633,34546088,Early Intensified Rehabilitation Training with Hyperbaric Oxygen Therapy Improves Functional Disorders and Prognosis of Patients with Traumatic Brain Injury.,"Objective:  Traumatic brain injury (TBI) is a global public health problem. Hyperbaric oxygen (HBO) therapy may be beneficial for TBI because it improves cerebral blood flow into tissues exhibiting low blood flow. This was done to observe the clinical therapeutic effect of different intensities of rehabilitation training and HBO therapy in early stages of TBI.  Approach:  In this multicenter, randomized, stratified case-controlled prospective clinical trial, we selected 158 patients with moderate-severe TBI and assigned them into (1) a control group receiving routine once-daily (1/d) rehabilitation training without HBO, (2) study group A receiving routine 1/d rehabilitation training with HBO, (3) study group B receiving twice-daily (2/d) intensified rehabilitation training with HBO, and (4) study group C receiving 2/d intensified rehabilitation training without HBO, all for 3 months. The cognitive ability, activities of daily life (ADL), and movement ability were assessed before and after training with the Fugl-Meyer Assessment (FMA), Functional Independence Measure (FIM), Modified Barthel Index (MBI), and Mini-Mental State Examination (MMSE).  Results:  FIM, FMA, MBI, and MMSE scores were improved significantly after 1-, 2-, and 3-month rehabilitation training in all TBI patients ( p  < 0.01), and this improvement was especially remarkable in patients who received 2/d intensified rehabilitation training with HBO ( p  < 0.01).  Innovation:  With extensive and intensive research on TBI rehabilitation, it was proved that TBI rehabilitation intervention should be initiated as early as possible.  Conclusion:  Early intensified rehabilitation training in combination with HBO is more beneficial to the recovery of cognitive, ADL, and movement abilities of TBI patients.",2021,"The cognitive ability, activities of daily life (ADL), and movement ability were assessed before and after training with the Fugl-Meyer Assessment (FMA), Functional Independence Measure (FIM), Modified Barthel Index (MBI), and Mini-Mental State Examination (MMSE).  ","['Patients with Traumatic Brain Injury', '158 patients with moderate-severe TBI and assigned them into (1) a']","['rehabilitation training and HBO therapy', 'Hyperbaric oxygen (HBO) therapy', 'Traumatic brain injury (TBI', 'control group receiving routine once-daily (1/d) rehabilitation training without HBO, (2) study group A receiving routine 1/d rehabilitation training with HBO, (3) study group B receiving twice-daily (2/d) intensified rehabilitation training with HBO, and (4) study group C receiving 2/d intensified rehabilitation training without HBO', 'Hyperbaric Oxygen Therapy']","['Fugl-Meyer Assessment (FMA), Functional Independence Measure (FIM), Modified Barthel Index (MBI), and Mini-Mental State Examination (MMSE', 'Results:  FIM, FMA, MBI, and MMSE scores', 'cognitive ability, activities of daily life (ADL), and movement ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",158.0,0.0041672,"The cognitive ability, activities of daily life (ADL), and movement ability were assessed before and after training with the Fugl-Meyer Assessment (FMA), Functional Independence Measure (FIM), Modified Barthel Index (MBI), and Mini-Mental State Examination (MMSE).  ","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'College of Biology and Environmental Engineering, Zhejiang Shuren University, Hangzhou, China.'}, {'ForeName': 'Xianshan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Traumatic Rehabilitation Center of Hangzhou Sanatorium, Hangzhou, China.'}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Departments of Neurology and Surgery, Bengbu, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'College of Biology and Environmental Engineering, Zhejiang Shuren University, Hangzhou, China.'}]",Advances in wound care,['10.1089/wound.2018.0876']
1634,34536763,Effect of ultrasound-guided selective sensory nerve blockade of the knee on pain management compared with periarticular injection for patients undergoing total knee arthroplasty: A prospective randomized controlled trial.,"BACKGROUND


Ultrasound-guided selective sensory nerve blockade (SSNB) of the knee, including an adductor canal block (ACB), anterior femoral cutaneous nerve block, and infiltration between the popliteal artery and posterior capsule of the knee may provide effective motor-sparing knee analgesia for total knee arthroplasty (TKA). We hypothesized that the SSNB would manage pain better on ambulation 24 hours postoperatively compared to periarticular infiltration (PAI), when combined with postoperative continuous ACB.
METHODS


Seventy-two patients undergoing elective TKA under spinal anesthesia were randomly assigned to either SSNB (SSNB group) or intraoperative PAI (PAI group). All patients received postoperative multimodal analgesia, including continuous ACB. The primary outcome was pain on ambulation 24 hours postoperatively. Secondary outcomes included rest and dynamic numerical rating scale pain score, intravenous morphine requirement, functional performance measures, adverse events, satisfaction, and length of stay.
RESULTS


There was no difference in pain score during movement between the groups (mean difference -0.48 [-1.38 to 0.42], p = 0.3) and other immediate overall pain scores 24 hours postoperatively. Patients in the SSNB group had significantly lower intravenous morphine requirement than the PAI group for 48 hours postoperatively (0 [0, 0] vs. 0 [0, 2]; p = 0.008). There was no intergroup difference in the performance-based measures, satisfaction, and length of stay.
CONCLUSIONS


The SSNB did not provide superior postoperative analgesia, or improvement in immediate functional performance. However, it may result in lower opioid consumption postoperatively when compared with the intraoperative PAI.",2021,There was no difference in pain score during movement between the groups (mean difference -0.48,"['patients undergoing total knee arthroplasty', 'total knee arthroplasty (TKA', 'Seventy-two patients undergoing elective TKA under spinal anesthesia']","['Ultrasound-guided selective sensory nerve blockade (SSNB', 'SSNB', 'periarticular injection', 'SSNB (SSNB group) or intraoperative PAI (PAI group', 'postoperative multimodal analgesia, including continuous ACB', 'ultrasound-guided selective sensory nerve blockade']","['intravenous morphine requirement', 'immediate overall pain scores', 'immediate functional performance', 'pain score', 'rest and dynamic numerical rating scale pain score, intravenous morphine requirement, functional performance measures, adverse events, satisfaction, and length of stay', 'pain on ambulation 24 hours postoperatively', 'performance-based measures, satisfaction, and length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",72.0,0.322986,There was no difference in pain score during movement between the groups (mean difference -0.48,"[{'ForeName': 'Wirinaree', 'Initials': 'W', 'LastName': 'Kampitak', 'Affiliation': 'Department of Anesthesiology, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: wireena.K@chula.ac.th.'}, {'ForeName': 'Aree', 'Initials': 'A', 'LastName': 'Tanavalee', 'Affiliation': 'Department of Orthopedics, King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Srihatach', 'Initials': 'S', 'LastName': 'Ngarmukos', 'Affiliation': 'Department of Orthopedics, King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Chanida', 'Initials': 'C', 'LastName': 'Cholwattanakul', 'Affiliation': 'Department of Anesthesiology, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Lalita', 'Initials': 'L', 'LastName': 'Lertteerawattana', 'Affiliation': 'Department of Anesthesiology, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Supreeda', 'Initials': 'S', 'LastName': 'Dowkrajang', 'Affiliation': 'Department of Anesthesiology, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",The Knee,['10.1016/j.knee.2021.08.024']
1635,34535938,Earliest pulmonary vein potential-guided cryoballoon ablation is associated with better clinical outcomes than conventional cryoballoon ablation: A result from two randomized clinical studies.,"INTRODUCTION


With regard to short-term outcome in atrial fibrillation (AF), the benefit of cryoballoon ablation (CBA) by pressing a balloon against the earliest pulmonary vein (PV) potential site during PV isolation (earliest potential [EP]-guided CBA) has been previously demonstrated. The present study aimed to evaluate the long-term outcome of the EP-guided CBA.
METHODS AND RESULTS


This study included 136 patients from two randomized studies, who underwent CBA for paroxysmal AF for the first time. Patients were randomly assigned to the EP-guided and conventional CBA groups in each study. In the EP-guided CBA group, we pressed a balloon against the EP site when the time-to-isolation (TTI) after cryoapplication exceeded 60 and 45 s in the first and second studies, respectively. We compared the clinical outcomes for 1 year after the procedure between the EP-guided CBA group (68 patients) and the conventional CBA group (68 patients). The primary endpoint was the recurrence of atrial arrhythmia after ablation. No significant differences in baseline characteristics were observed between the two groups. Compared with the conventional CBA group, the EP-guided CBA group had a significantly higher success rate at TTI ≤ 90 s (98.5% vs. 90.0%, p < .001); lower touch-up rate and total cryoapplication; and shorter procedure time, and fluoroscopy time. The recurrence at 1 year after ablation was significantly lower in the EP-guided CBA group than in the conventional CBA group (6.0% vs. 19.4%; p = .019).
CONCLUSIONS


The EP-guided CBA approach can facilitate the ablation procedure and achieve low recurrence at 1 year after ablation.",2021,"The recurrence at 1 year after ablation was significantly lower in the EP-guided CBA group than in the conventional CBA group (6.0% vs. 19.4%; p = .019).
","['136 patients from two randomized studies, who underwent CBA for paroxysmal AF for the first time']","['conventional cryoballoon ablation', 'conventional CBA', 'EP-guided and conventional CBA', 'cryoballoon ablation (CBA', 'EP-guided CBA']","['touch-up rate and total cryoapplication; and shorter procedure time, and fluoroscopy time', 'baseline characteristics', 'success rate', 'recurrence of atrial arrhythmia after ablation', 'recurrence']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",136.0,0.0627126,"The recurrence at 1 year after ablation was significantly lower in the EP-guided CBA group than in the conventional CBA group (6.0% vs. 19.4%; p = .019).
","[{'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Mizutani', 'Affiliation': 'Department of Cardiology, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yanagisawa', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Kanashiro', 'Affiliation': 'Department of Cardiology, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Yamashita', 'Affiliation': 'Department of Cardiology, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yonekawa', 'Affiliation': 'Department of Cardiology, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Makino', 'Affiliation': 'Department of Cardiology, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Takatsugu', 'Initials': 'T', 'LastName': 'Hiramatsu', 'Affiliation': 'Department of Cardiology, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ichimiya', 'Affiliation': 'Department of Cardiology, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Department of Cardiology, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiology, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ichimiya', 'Affiliation': 'Department of Cardiology, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Yasuya', 'Initials': 'Y', 'LastName': 'Inden', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.15246']
1636,34535716,Effect of liraglutide on expression of inflammatory genes in type 2 diabetes.,"Anti-inflammatory effects of glucagon-like peptide 1 receptor agonist (GLP-1 RA) treatment in T2D may contribute to the cardiovascular benefits observed with GLP-1 RAs in outcome studies. We investigated if the GLP-1 RA liraglutide exerts anti-inflammatory effects through modulation of inflammatory gene expression in peripheral blood mononuclear cells (PBMCs). From 54 participants of a double-blinded trial where individuals with type 2 diabetes (T2D) were randomized to liraglutide (1.8 mg/day) or placebo for 26 weeks, a sub-study was performed in which PBMCs were extracted from fresh blood at study start and at end-of-treatment. The expression of selected inflammatory genes in PBMCs were measured by quantitative real-time polymerase chain reaction (PCR). Moreover, the expression of the GLP-1 receptor (GLP1R) was examined in a subset (n = 40) of the PBMC samples. The human monocytic cell line THP-1 was used for in vitro GLP-1 exposure experiments. The expression of tumor necrosis factor-α (TNFA) (p = 0.004) and interleukin-1β (IL1B) was downregulated (p = 0.046) in the liraglutide-treated group (n = 31), and unchanged in the placebo group (n = 21, p ≥ 0.11), with no significant differences between the two groups (p ≥ 0.67). The expression of interferon-γ (IFNG) and cluster of differentiation 163 (CD163) were upregulated in both groups (p ≤ 0.006) with no differences between groups (p ≥ 0.47). C-C Motif Chemokine Ligand 5 (CCL5) was upregulated in the liraglutide-treated group (p = 0.002) and unchanged in the placebo group (p = 0.14), with no significant difference between groups (p = 0.36). Intercellular adhesion molecule 1 (ICAM1) was unchanged in both groups (p ≥ 0.43). GLP1R expression in the PBMCs was undetectable. In vitro experiments showed no effect of GLP-1 treatment on inflammatory gene expression in THP-1 cells. GLP1R expression in THP-1 cells was not detectable. In summary, we observed a discrete modulatory effect of liraglutide on the expression of inflammatory genes in PBMCs. The lack of evidence for GLP1R expression in PBMCs and THP-1 cells suggests that possible effects of liraglutide on the PBMCs' gene expression are most likely indirect. Further investigations are needed to establish the anti-inflammatory potential of GLP-1 RAs.",2021,The expression of interferon-γ (IFNG) and cluster of differentiation 163 (CD163) were upregulated in both groups (p ≤ 0.006) with no differences between groups (p ≥ 0.47).,"['54 participants\xa0of a double-blinded trial where individuals with type 2 diabetes (T2D', 'type 2 diabetes']","['GLP-1 RA liraglutide', 'GLP-1', 'liraglutide', 'glucagon-like peptide 1 receptor agonist (GLP-1 RA', 'placebo']","['GLP1R expression', 'GLP1R expression in THP-1 cells', 'C-C Motif Chemokine Ligand 5 (CCL5', 'Intercellular adhesion molecule 1 (ICAM1', 'expression of interferon-γ (IFNG) and cluster of differentiation 163 (CD163', 'interleukin-1β (IL1B', 'expression of tumor necrosis factor-α (TNFA', 'expression of the GLP-1 receptor (GLP1R']","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C4505192', 'cui_str': 'THP-1 Cell Line'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",,0.11154,The expression of interferon-γ (IFNG) and cluster of differentiation 163 (CD163) were upregulated in both groups (p ≤ 0.006) with no differences between groups (p ≥ 0.47).,"[{'ForeName': 'Emilie H', 'Initials': 'EH', 'LastName': 'Zobel', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820, Gentofte, Denmark. emilie.hein.zobel@regionh.dk.'}, {'ForeName': 'Rasmus S', 'Initials': 'RS', 'LastName': 'Ripa', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bernt J', 'Initials': 'BJ', 'LastName': 'von Scholten', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820, Gentofte, Denmark.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Rotbain Curovic', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820, Gentofte, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kjaer', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tine W', 'Initials': 'TW', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820, Gentofte, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820, Gentofte, Denmark.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Størling', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820, Gentofte, Denmark.'}]",Scientific reports,['10.1038/s41598-021-97967-0']
1637,34533034,Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre-Specified Analysis of the GLOBAL LEADERS Trial.,"Background The optimal duration of dual antiplatelet therapy after coronary drug-eluting stent placement in adults with stable coronary artery disease (SCAD) versus acute coronary syndromes (ACS) remains uncertain. Methods and Results This was a prespecified subgroup analysis of the GLOBAL LEADERS trial. Participants were randomly assigned 1:1 to the experimental or reference strategy, stratified by ACS (experimental, n=3750; reference, n=3737) versus SCAD (experimental, n=4230; reference, n=4251). The experimental strategy was 75 to 100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy. The reference strategy was 75 to 100 mg aspirin daily plus either 75 mg clopidogrel daily (for SCAD) or 90 mg ticagrelor twice daily (for ACS) for 12 months, followed by aspirin monotherapy for 12 months. The primary end point at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction. The key secondary safety end point was site-reported Bleeding Academic Research Consortium grade 3 or 5 bleeding. The primary end point occurred in 147 (3.92%) versus 169 (4.52%) patients with ACS (rate ratio [RR], 0.86; 95% CI, 0.69-1.08;  P =0.189), and in 157 (3.71%) versus 180 (4.23%) patients with SCAD (RR, 0.87; 95% CI, 0.71-1.08;  P =0.221) with experimental and reference strategy, respectively ( P -interaction=0.926). Bleeding Academic Research Consortium grade 3 or 5 bleeding occurred in 73 (1.95%) versus 100 (2.68%) patients with ACS (RR, 0.73; 95% CI, 0.54-0.98;  P =0.037), and in 90 (2.13%) versus 69 (1.62%) patients with SCAD (RR, 1.32; 95% CI, 0.97-1.81;  P =0.081;  P -interaction=0.007). Conclusions While there was no evidence for differences in efficacy between treatment strategies by subgroup, the experimental strategy appeared to reduce bleeding risk in patients with ACS but not in patients with SCAD. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.",2021,"While there was no evidence for differences in efficacy between treatment strategies by subgroup, the experimental strategy appeared to reduce bleeding risk in patients with ACS but not in patients with SCAD.",['adults with stable coronary artery disease (SCAD) versus acute coronary syndromes (ACS'],"['aspirin daily plus 90\xa0mg ticagrelor', 'coronary drug-eluting stent placement', 'ticagrelor', 'aspirin', 'Ticagrelor Monotherapy', 'ticagrelor monotherapy', 'aspirin monotherapy']","['Bleeding Academic Research Consortium grade 3 or 5 bleeding', 'Efficacy and Safety', 'composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction', 'bleeding risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C4286029', 'cui_str': 'Drug-eluting stent placement'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.241642,"While there was no evidence for differences in efficacy between treatment strategies by subgroup, the experimental strategy appeared to reduce bleeding risk in patients with ACS but not in patients with SCAD.","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Jessa Ziekenhuis Faculty of Medicine and Life Sciences at the Hasselt University Hasselt Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology University of BernInselspital Bern Switzerland.'}, {'ForeName': 'Ayodele', 'Initials': 'A', 'LastName': 'Odutayo', 'Affiliation': ""Department of Medicine and Institute of Health Policy, Management and Evaluation Applied Health Research CentreLi Ka Shing Knowledge Institute of St. Michael's HospitalUniversity of Toronto Canada.""}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College London London United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart and Thorax Center Bad Nauheim Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'INSERM U-1148 FACT (French Alliance for Cardiovascular Trials) Hôpital BichatAssistance Publique-Hôpitaux de ParisUniversité de Paris France.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Clinical Trials Unit University of Bern Switzerland.'}, {'ForeName': 'Eugene P', 'Initials': 'EP', 'LastName': 'Mc Fadden', 'Affiliation': 'Cork University Hospital Cork Ireland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Cardialysis Rotterdam The Netherlands.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Benit', 'Affiliation': 'Jessa Ziekenhuis Faculty of Medicine and Life Sciences at the Hasselt University Hasselt Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Imeldaziekenhuis Bonheiden Belgium.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Erasmus Medical Center Rotterdam The Netherlands.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Ferrario', 'Affiliation': 'UOC Cardiologia Fondazione IRCCS Policlinico San Matteo Pavia Italy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine Medical Faculty Wilhelminen Hospital and Sigmund Freud University Vienna Austria.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Department of Cardiology University of BernInselspital Bern Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology University of BernInselspital Bern Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Department of Medicine and Institute of Health Policy, Management and Evaluation Applied Health Research CentreLi Ka Shing Knowledge Institute of St. Michael's HospitalUniversity of Toronto Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.119.015560']
1638,34555333,"Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial.","BACKGROUND


Novel adjuvant strategies are needed to optimise outcomes after complete surgical resection in patients with early-stage non-small-cell lung cancer (NSCLC). We aimed to evaluate adjuvant atezolizumab versus best supportive care after adjuvant platinum-based chemotherapy in these patients.
METHODS


IMpower010 was a randomised, multicentre, open-label, phase 3 study done at 227 sites in 22 countries and regions. Eligible patients were 18 years or older with completely resected stage IB (tumours ≥4 cm) to IIIA NSCLC per the Union Internationale Contre le Cancer and American Joint Committee on Cancer staging system (7th edition). Patients were randomly assigned (1:1) by a permuted-block method (block size of four) to receive adjuvant atezolizumab (1200 mg every 21 days; for 16 cycles or 1 year) or best supportive care (observation and regular scans for disease recurrence) after adjuvant platinum-based chemotherapy (one to four cycles). The primary endpoint, investigator-assessed disease-free survival, was tested hierarchically first in the stage II-IIIA population subgroup whose tumours expressed PD-L1 on 1% or more of tumour cells (SP263), then all patients in the stage II-IIIA population, and finally the intention-to-treat (ITT) population (stage IB-IIIA). Safety was evaluated in all patients who were randomly assigned and received atezolizumab or best supportive care. IMpower010 is registered with ClinicalTrials.gov, NCT02486718 (active, not recruiting).
FINDINGS


Between Oct 7, 2015, and Sept 19, 2018, 1280 patients were enrolled after complete resection. 1269 received adjuvant chemotherapy, of whom 1005 patients were eligible for randomisation to atezolizumab (n=507) or best supportive care (n=498); 495 in each group received treatment. After a median follow-up of 32·2 months (IQR 27·4-38·3) in the stage II-IIIA population, atezolizumab treatment improved disease-free survival compared with best supportive care in patients in the stage II-IIIA population whose tumours expressed PD-L1 on 1% or more of tumour cells (HR 0·66; 95% CI 0·50-0·88; p=0·0039) and in all patients in the stage II-IIIA population (0·79; 0·64-0·96; p=0·020). In the ITT population, HR for disease-free survival was 0·81 (0·67-0·99; p=0·040). Atezolizumab-related grade 3 and 4 adverse events occurred in 53 (11%) of 495 patients and grade 5 events in four patients (1%).
INTERPRETATION


IMpower010 showed a disease-free survival benefit with atezolizumab versus best supportive care after adjuvant chemotherapy in patients with resected stage II-IIIA NSCLC, with pronounced benefit in the subgroup whose tumours expressed PD-L1 on 1% or more of tumour cells, and no new safety signals. Atezolizumab after adjuvant chemotherapy offers a promising treatment option for patients with resected early-stage NSCLC.
FUNDING


F Hoffmann-La Roche and Genentech.",2021,"In the ITT population, HR for disease-free survival was 0·81 (0·67-0·99; p=0·040).","['patients with early-stage non-small-cell lung cancer (NSCLC', 'Between Oct 7, 2015, and Sept 19, 2018, 1280 patients were enrolled after complete resection', 'IMpower010 was a randomised, multicentre, open-label, phase 3 study done at 227 sites in 22 countries and regions', '1005 patients were eligible for randomisation to atezolizumab (n=507) or best supportive care (n=498); 495 in each group received treatment', 'resected stage IB-IIIA non-small-cell lung cancer (IMpower010', 'patients with resected early-stage NSCLC', 'Eligible patients were 18 years or older with completely resected stage IB (tumours ≥4 cm) to IIIA NSCLC per the Union Internationale Contre le Cancer and American Joint Committee on Cancer staging system (7th edition']","['permuted-block method (block size of four) to receive adjuvant atezolizumab', 'adjuvant chemotherapy', 'atezolizumab', 'supportive care (observation and regular scans for disease recurrence) after adjuvant platinum-based chemotherapy', 'atezolizumab or best supportive care', 'Adjuvant atezolizumab', 'Atezolizumab', 'adjuvant platinum-based chemotherapy']","['disease-free survival', 'investigator-assessed disease-free survival', 'Atezolizumab-related grade 3 and 4 adverse events', 'HR for disease-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C1310510', 'cui_str': 'POU3F2 protein, human'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}, {'cui': 'C0441792', 'cui_str': 'Editions'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1280.0,0.612918,"In the ITT population, HR for disease-free survival was 0·81 (0·67-0·99; p=0·040).","[{'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain. Electronic address: efelip@vhio.net.""}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Altorki', 'Affiliation': 'Division of Thoracic Surgery, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, NY, USA.'}, {'ForeName': 'Caicun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, Tongji University Affiliated Shanghai Pulmonary Hospital, Shanghai, China.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csőszi', 'Affiliation': 'Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet, Szolnok, Hungary.'}, {'ForeName': 'Ihor', 'Initials': 'I', 'LastName': 'Vynnychenko', 'Affiliation': 'Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary, Sumy State University, Sumy, Ukraine.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Goloborodko', 'Affiliation': 'MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology, Zaporizhzhya, Ukraine.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Thoracic Surgery, Leningrad Regional Clinical Hospital, Saint Petersburg, Russia.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Akopov', 'Affiliation': 'Research Institute of Pulmonology, Pavlov State Medical University, Saint Petersburg, Russia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Martinez-Marti', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Kenmotsu', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yuh-Min', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital and National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Chella', 'Affiliation': 'Pneumology Unit, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Voong', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Roche (China) Holding, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yi', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McCleland', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bennett', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gitlitz', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Wakelee', 'Affiliation': 'Department of Medicine, Division of Oncology, Stanford University School of Medicine and Stanford Cancer Institute, Stanford, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)02098-5']
1639,34554689,Viable Disc Tissue Allograft Supplementation; One- and Two-level Treatment of Degenerated Intervertebral Discs in Patients with Chronic Discogenic Low Back Pain: One Year Results of the VAST Randomized Controlled Trial.,,2021,,['Patients with Chronic Discogenic Low Back Pain'],"['Viable Disc Tissue Allograft Supplementation', 'One- and Two-level Treatment of Degenerated Intervertebral Discs']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0021815', 'cui_str': 'Structure of intervertebral disc'}]",[],,0.199836,,"[{'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Beall', 'Affiliation': 'Department of Radiology, Summit Medical Center, Edmond, OK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Davis', 'Affiliation': 'Source Healthcare, Santa Monica, CA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'DePalma', 'Affiliation': 'Virginia iSpine Physicians, Richmond, VA.'}, {'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Amirdelfan', 'Affiliation': 'IPM Medical Group, Inc., Walnut Creek, CA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Yoon', 'Affiliation': 'Department of Radiology, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Wilson', 'Affiliation': 'Invictus Healthcare, Tulsa, OK.'}, {'ForeName': 'Randolph', 'Initials': 'R', 'LastName': 'Bishop', 'Affiliation': 'Advanced Neurosurgical Solutions, Savannah, GA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Tally', 'Affiliation': 'Athens Orthopedic Clinic, Spinal Division, Athens, GA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Gershon', 'Affiliation': 'Gershon Pain Specialists, Virginia Beach, VA.'}, {'ForeName': 'Morgan P', 'Initials': 'MP', 'LastName': 'Lorio', 'Affiliation': 'Advanced Orthopedics & Spine Surgery, Altamonte Springs, FL.'}, {'ForeName': 'Hans Joerg', 'Initials': 'HJ', 'LastName': 'Meisel', 'Affiliation': 'Center of Neurosciences/Department of Neurosurgery, BG Klinikum Bergmannstrost, Halle, Germany.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Langhorst', 'Affiliation': 'Spinal Diagnostics & therapeutics OrthoIndy, Fishers, IN.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Ganey', 'Affiliation': 'VIVEX Biologics, Inc., Miami, FL.'}, {'ForeName': 'Corey W', 'Initials': 'CW', 'LastName': 'Hunter', 'Affiliation': 'Dept. Physical Medicine and Rehabilitation, Ainsworth Institute of Pain Management, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",Pain physician,[]
1640,34547084,Effect of School Integrated Pest Management or Classroom Air Filter Purifiers on Asthma Symptoms in Students With Active Asthma: A Randomized Clinical Trial.,"Importance


School and classroom allergens and particles are associated with asthma morbidity, but the benefit of environmental remediation is not known.
Objective


To determine whether use of a school-wide integrated pest management (IPM) program or high-efficiency particulate air (HEPA) filter purifiers in the classrooms improve asthma symptoms in students with active asthma.
Design, Setting, and Participants


Factorial randomized clinical trial of a school-wide IPM program and HEPA filter purifiers in the classrooms was conducted from 2015 to 2020 (School Inner-City Asthma Intervention Study). There were 236 students with active asthma attending 41 participating urban elementary schools located in the Northeastern US who were randomized to IPM by school and HEPA filter purifiers by classroom. The date of final follow-up was June 20, 2020.
Interventions


The school-wide IPM program consisted of application of rodenticide, sealing entry points, trap placement, targeted cleaning, and brief educational handouts for school staff. Infestation was assessed every 3 months, with additional treatments as needed. Control schools received no IPM, cleaning, or education. Classroom portable HEPA filter purifiers were deployed and the filters were changed every 3 months. Control classrooms received sham HEPA filters that looked and sounded like active HEPA filter purifiers. Randomization was done independently (split-plot design), with matching by the number of enrolled students to ensure a nearly exact 1:1 student ratio for each intervention with 118 students randomized to each group. Participants, investigators, and those assessing outcomes were blinded to the interventions.
Main Outcomes and Measures


The primary outcome was the number of symptom-days with asthma during a 2-week period. Symptom-days were assessed every 2 months during the 10 months after randomization.
Results


Among the 236 students who were randomized (mean age, 8.1 [SD, 2.0] years; 113 [48%] female), all completed the trial. At baseline, the 2-week mean was 2.2 (SD, 3.9) symptom-days with asthma and 98% of the classrooms had detectable levels of mouse allergen. The results were pooled because there was no statistically significant difference between the 2 interventions (P = .18 for interaction). During a 2-week period, the mean was 1.5 symptom-days with asthma after use of the school-wide IPM program vs 1.9 symptom-days after no IPM across the school year (incidence rate ratio, 0.71 [95% CI, 0.38-1.33]), which was not statistically significantly different. During a 2-week period, the mean was 1.6 symptom-days with asthma after use of HEPA filter purifiers in the classrooms vs 1.8 symptom-days after use of sham HEPA filter purifiers across the school year (incidence rate ratio, 1.47 [95% CI, 0.79-2.75]), which was not statistically significantly different. There were no intervention-related adverse events.
Conclusions and Relevance


Among children with active asthma, use of a school-wide IPM program or classroom HEPA filter purifiers did not significantly reduce symptom-days with asthma. However, interpretation of the study findings may need to consider allergen levels, particle exposures, and asthma symptoms at baseline.
Trial Registration


ClinicalTrials.gov Identifier: NCT02291302.",2021,The results were pooled because there was no statistically significant difference between the 2 interventions (P = .18 for interaction).,"['children with active asthma', 'students with active asthma', 'Students With Active Asthma', '236 students with active asthma attending 41 participating urban elementary schools located in the Northeastern US who were randomized to IPM by school and HEPA filter purifiers by classroom', 'purifiers in the classrooms was conducted from 2015 to 2020 (School Inner-City Asthma Intervention Study', '236 students who were randomized (mean age, 8.1 [SD, 2.0] years; 113 [48%] female']","['school-wide IPM program and HEPA filter', 'school-wide integrated pest management (IPM) program or high-efficiency particulate air (HEPA) filter purifiers', 'sham HEPA filters', 'School Integrated Pest Management or Classroom Air Filter Purifiers']","['asthma symptoms', 'Infestation', 'detectable levels of mouse allergen', 'number of symptom-days with asthma']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0031249', 'cui_str': 'Pest control'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0180861', 'cui_str': 'Air filter'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0031249', 'cui_str': 'Pest control'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0180861', 'cui_str': 'Air filter'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030499', 'cui_str': 'Disease caused by parasite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",236.0,0.140205,The results were pooled because there was no statistically significant difference between the 2 interventions (P = .18 for interaction).,"[{'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Allergy and Immunology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Koutrakis', 'Affiliation': 'Department of Environmental Health, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Coull', 'Affiliation': 'Department of Environmental Health, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Carter R', 'Initials': 'CR', 'LastName': 'Petty', 'Affiliation': ""Biostatistics and Research Design Center, Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Gaffin', 'Affiliation': 'Harvard University Medical School, Boston, Massachusetts.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sheehan', 'Affiliation': ""Division of Allergy and Immunology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Peggy S', 'Initials': 'PS', 'LastName': 'Lai', 'Affiliation': 'Harvard University Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Bartnikas', 'Affiliation': ""Division of Allergy and Immunology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Choong-Min', 'Initials': 'CM', 'LastName': 'Kang', 'Affiliation': 'Department of Environmental Health, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Wolfson', 'Affiliation': 'Department of Environmental Health, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Mihail', 'Initials': 'M', 'LastName': 'Samnaliev', 'Affiliation': ""Biostatistics and Research Design Center, Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Amparito', 'Initials': 'A', 'LastName': 'Cunningham', 'Affiliation': ""Division of Allergy and Immunology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sachin N', 'Initials': 'SN', 'LastName': 'Baxi', 'Affiliation': ""Division of Allergy and Immunology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Perdita', 'Initials': 'P', 'LastName': 'Permaul', 'Affiliation': 'Division of Pediatric Allergy and Immunology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Hauptman', 'Affiliation': 'Harvard University Medical School, Boston, Massachusetts.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Division of Pediatric Pulmonology and Department of Population and Quantitative Health Sciences, University of Massachusetts Memorial Medical School, Worcester.'}, {'ForeName': 'Margee', 'Initials': 'M', 'LastName': 'Louisias', 'Affiliation': ""Division of Allergy and Immunology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Biostatistics, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Thorne', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City.'}, {'ForeName': 'Nervana', 'Initials': 'N', 'LastName': 'Metwali', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Adamkiewicz', 'Affiliation': 'Department of Environmental Health, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': 'Department of Environmental Health, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Baccarelli', 'Affiliation': 'Department of Environmental Health, School of Public Health, Columbia University, New York, New York.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': 'Harvard University Medical School, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2021.11559']
1641,34560383,Quality of life in patients with locally advanced head and neck cancer treated with concurrent chemoradiation with cisplatin and nimotuzumab versus cisplatin alone - Additional data from a phase 3 trial.,"INTRODUCTION


The addition of Nimotuzumab to radical chemoradiation (CRT) improved outcomes in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing radical CRT in a phase 3 randomized trial. The current study focuses on the quality of life (QoL) of patients in this trial.
METHODS


In this phase III randomized trial, patients with newly diagnosed, nonmetastatic, stage III/IV LAHNSCC of the oral cavity, oropharynx, hypopharynx, or larynx were randomized to receive cisplatin 30 mg/m 2  or cisplatin 30 mg/m 2  with nimotuzumab once a week with curative radiotherapy. The primary end point of the trial was PFS. The aim of the current study was to compare the QoL between the two arms. QoL was assessed using the EORTC QLQ-C30 (v3.0) and HN-35 (v1.0). The linear mixed-effects model was used for longitudinal analysis of QoL.
RESULTS


536 patients were randomized in this trial (268 in each arm) and 423 patients were included for QoL analysis. There was a significant change in the global health status QoL scores over time (p = 0.0016) with no difference between the two arms (p = 0.396). On longitudinal analysis there was a significant difference in the QoL scores in most of the function & symptom scales over time, but there was no significant difference in these scores between the two arms. QoL scores for most symptom scales worsened during treatment and improved thereafter in both arms.
CONCLUSION


The addition of nimotuzumab to cisplatin based chemoradiation in LAHNSCC improved PFS, LRC and DFS without negatively impacting QoL.",2021,"On longitudinal analysis there was a significant difference in the QoL scores in most of the function & symptom scales over time, but there was no significant difference in these scores between the two arms.","['patients with newly diagnosed, nonmetastatic, stage III/IV LAHNSCC of the oral cavity, oropharynx, hypopharynx, or larynx', 'patients with locally advanced head and neck cancer treated with', '536 patients were randomized in this trial (268 in each arm) and 423 patients were included for QoL analysis', 'patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing']","['nimotuzumab to cisplatin', 'concurrent chemoradiation with cisplatin and nimotuzumab versus cisplatin', 'nimotuzumab', 'radical CRT', 'Nimotuzumab to radical chemoradiation (CRT', 'cisplatin 30']","['quality of life (QoL', 'PFS, LRC and DFS without negatively impacting QoL', 'Quality of life', 'global health status QoL scores', 'QoL scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1570308', 'cui_str': 'Nimotuzumab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",536.0,0.114205,"On longitudinal analysis there was a significant difference in the QoL scores in most of the function & symptom scales over time, but there was no significant difference in these scores between the two arms.","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Menon', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Patil', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Atanu', 'Initials': 'A', 'LastName': 'Bhattacharjee', 'Affiliation': 'Section of Biostatistics, Centre for Cancer Epidemiology, Advanced Centre for Treatment, Research and Edcation in Cancer, Navi Mumbai, India.'}, {'ForeName': 'Balajirao J', 'Initials': 'BJ', 'LastName': 'Satam', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Vijayalakshmi', 'Initials': 'V', 'LastName': 'Mathrudev', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Sarbani', 'Initials': 'S', 'LastName': 'Ghosh Laskar', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India. Electronic address: kumarprabhashtmh@gmail.com.'}]",Oral oncology,['10.1016/j.oraloncology.2021.105517']
1642,34560319,A randomized sham controlled comparison of once vs twice-daily intermittent theta burst stimulation in depression: A Canadian rTMS treatment and biomarker network in depression (CARTBIND) study.,"BACKGROUND


Intermittent theta burst stimulation (iTBS) is a newer form of repetitive transcranial magnetic stimulation (rTMS) for patients with treatment resistant depression (TRD). Applying multiple daily iTBS sessions may enable patients to achieve remission more rapidly.
OBJECTIVE


We compared the efficacy and tolerability of a twice-daily versus once-daily iTBS protocol in patients with TRD. We hypothesized that twice-daily iTBS would result in a greater improvement in depression scores compared to once-daily iTBS.
METHODS


208 participants (131 females) with TRD were randomized to receive either iTBS (600 pulses) delivered twice-daily with a 54-min interval between treatments or once-daily (1200 pulses) with 1 sham treatment with the same interval between treatments, to ensure equal levels of daily therapeutic contact and blinding of patients and raters. The primary outcome measure was change in depression scores on the Hamilton Rating Scale for Depression (HRSD-17) after 10 days of treatment and 30 days of treatments.
RESULTS


HRSD-17 scores improved in both the twice-daily and once-daily iTBS groups; however, these improvements did not significantly differ between the two groups at either the 10-day or 30-day timepoints. Response and remission rates were low (<10%) in both groups after 10 days and consistent with prior reports at 30 days; these rates did not differ between the treatment groups.
CONCLUSIONS


These results suggest that twice-daily iTBS does not accelerate response to iTBS and is not different from once-daily treatment in terms of improving depressive symptoms in patients with TRD. Clinicaltrials.gov ID: NCT02729792 (https://clinicaltrials.gov/ct2/show/NCT02729792).",2021,"RESULTS


HRSD-17 scores improved in both the twice-daily and once-daily iTBS groups; however, these improvements did not significantly differ between the two groups at either the 10-day or 30-day timepoints.","['patients with TRD', 'depression', '208 participants (131 females) with TRD', 'patients with treatment resistant depression (TRD']","['Hypothesis', 'repetitive transcranial magnetic stimulation (rTMS', 'Intermittent theta burst stimulation (iTBS', 'iTBS']","['efficacy and tolerability', 'depression scores', 'change in depression scores on the Hamilton Rating Scale for Depression (HRSD-17', 'Response and remission rates', 'HRSD-17 scores', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",208.0,0.162221,"RESULTS


HRSD-17 scores improved in both the twice-daily and once-daily iTBS groups; however, these improvements did not significantly differ between the two groups at either the 10-day or 30-day timepoints.","[{'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, M6J1H4, Canada; Department of Psychiatry and Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, M5S 1A8, Canada. Electronic address: daniel.blumberger@camh.ca.'}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Vila-Rodriguez', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, V6T 2A1, Canada.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, M6J1H4, Canada; College of Public Health, University of South Florida, Tampa, 33612, USA.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, M6J1H4, Canada; Department of Psychiatry and Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, M5S 1A8, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Butterfield', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, V6T 2A1, Canada.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Noda', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Shahak', 'Initials': 'S', 'LastName': 'Yariv', 'Affiliation': 'Department of Psychiary, Emek Medical Center General Hospital, Afula, 1834111, Israel; Faculty of Medicine, Technion- Israel Institute of Technology, Haifa, 3525433, Israel.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Isserles', 'Affiliation': 'The Jerusalem Center for Mental Health, Jerusalem, 91060, Israel.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, M6J1H4, Canada; Department of Psychiatry and Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, M5S 1A8, Canada.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Ainsworth', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, V6T 2A1, Canada.'}, {'ForeName': 'Sidney H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': 'Department of Psychiatry and Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, M5S 1A8, Canada; St. Michaels Hospital, Unity Health, Toronto, ON, M5B 1W8, Canada; Centre for Mental Health and Krembil Research Institute, University Health Network, Toronto, M5T 0S8, Canada.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, V6T 2A1, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Psychiatry, University of California San Diego, California, USA, 92093.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Department of Psychiatry and Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, M5S 1A8, Canada; Centre for Mental Health and Krembil Research Institute, University Health Network, Toronto, M5T 0S8, Canada.'}]",Brain stimulation,['10.1016/j.brs.2021.09.003']
1643,34560141,Cooperate or aggress? An opponent's tendency to cooperate modulates the neural dynamics of interpersonal cooperation.,"Humans are social animals and need to cooperate to survive. However, individuals are not cooperative in every social interaction, and their cooperation may depend on social context. The present study used a social dilemma game to investigate whether an opponent's tendency to be cooperative over time influenced a player's behavior and neural response to outcomes in the game. University students (""players"") thought they were playing against other students (""opponents"") in the Chicken Game but were actually playing against a programmed computer. Participants were randomly assigned to play with an opponent who tended to be competitive (cooperative 20% of the time) or who tended to be cooperative (cooperative 80% of the time). The results showed that early in the game, participants in both groups adopted a ""tit-for-tat"" strategy. However, as the game progressed and the opponent's behavioral tendency became more noticeable, players in the competitive-opponent group became generally more cooperative to limit their losses. ERPs analyses indicated that players had a higher P300 and larger theta power in response to the opponent's aggression but not to the opponent's cooperation when their opponent showed a tendency to be cooperative vs. competitive. The results suggest that people adjust their cooperative behavior based on their opponent's behavior in social interaction, and aggression captures more attention than cooperation in this process.",2021,ERPs analyses indicated that players had a higher P300 and larger theta power in response to the opponent's aggression but not to the opponent's cooperation when their opponent showed a tendency to be cooperative vs. competitive.,"['University students (""players"") thought they were playing against other students (""opponents"") in the Chicken Game but were actually playing against a programmed computer']",[],[],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0521124', 'cui_str': 'Against'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009622', 'cui_str': 'Computer'}]",[],[],,0.0340771,ERPs analyses indicated that players had a higher P300 and larger theta power in response to the opponent's aggression but not to the opponent's cooperation when their opponent showed a tendency to be cooperative vs. competitive.,"[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of the Ministry of Education and School of Psychology, Central China Normal University, Wuhan, China; School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'School of Economics and Management, Fuzhou University, Fuzhou, 350108, China; Institute of Psychological and Cognitive Sciences, Fuzhou University, Fuzhou, China.'}, {'ForeName': 'Tianlong', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Mengfei', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'Department of Psychology, Manhattanville College, New York, NY, USA.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of the Ministry of Education and School of Psychology, Central China Normal University, Wuhan, China; School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Economics and Management, Fuzhou University, Fuzhou, 350108, China; Institute of Psychological and Cognitive Sciences, Fuzhou University, Fuzhou, China. Electronic address: wangeven@126.com.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2021.108025']
1644,34560136,A pre-specified analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial on the incidence of abrupt declines in kidney function.,"This pre-specified analysis of DAPA-CKD assessed the impact of sodium-glucose cotransporter 2 inhibition on abrupt declines in kidney function in high-risk patients based on having chronic kidney disease (CKD) and substantial albuminuria. DAPA-CKD was a randomized, double-blind, placebo-controlled trial that had a median follow-up of 2.4 years. Adults with CKD (urinary albumin-to-creatinine ratio 200-5000 mg/g and estimated glomerular filtration rate 25-75 mL/min/1.73m 2 ) were randomized to dapagliflozin 10 mg/day matched to placebo (2152 individuals each). An abrupt decline in kidney function was defined as a pre-specified endpoint of doubling of serum creatinine between two subsequent study visits. We also assessed a post-hoc analysis of investigator-reported acute kidney injury-related serious adverse events. Doubling of serum creatinine between two subsequent visits (median time-interval 100 days) occurred in 63 (2.9%) and 91 (4.2%) participants in the dapagliflozin and placebo groups, respectively (hazard ratio 0.68 [95% confidence interval 0.49, 0.94]). Accounting for the competing risk of mortality did not alter our findings. There was no heterogeneity in the effect of dapagliflozin on abrupt declines in kidney function based on baseline subgroups. Acute kidney injury-related serious adverse events were not significantly different and occurred in 52 (2.5%) and 69 (3.2%) participants in the dapagliflozin and placebo groups, respectively (0.77 [0.54, 1.10]). Thus, in patients with CKD and substantial albuminuria, dapagliflozin reduced the risk of abrupt declines in kidney function.",2021,There was no heterogeneity in the effect of dapagliflozin on abrupt declines in kidney function based on baseline subgroups.,"['Chronic Kidney Disease (DAPA-CKD', 'Adults with CKD (urinary albumin-to-creatinine ratio', 'high risk patients based on having chronic kidney disease (CKD) and severe albuminuria']","['dapagliflozin 10 mg/day matched to placebo', 'placebo', 'dapagliflozin', 'DAPA']","['Acute kidney injury-related serious adverse events', 'kidney function', 'Doubling of serum creatinine']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}]",,0.324694,There was no heterogeneity in the effect of dapagliflozin on abrupt declines in kidney function based on baseline subgroups.,"[{'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; The George Institute for Global Health, Sydney, Australia. Electronic address: h.j.lambers.heerspink@umcg.nl.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cherney', 'Affiliation': 'Department of Medicine, Division of Nephrology, University Health Network and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Douwe', 'Initials': 'D', 'LastName': 'Postmus', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefánsson', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Department of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, USA.'}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': 'Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City, Utah, USA.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Kosiborod', 'Affiliation': ""The George Institute for Global Health, Sydney, Australia; Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City, Missouri, USA.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'The National Medical Science and Nutrition Institute Salvador Zubiran, Mexico City, Mexico.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Toto', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia; Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2021.09.005']
1645,34559837,The MoveStrong program for promoting balance and functional strength training and adequate protein intake in pre-frail older adults: A pilot randomized controlled trial.,"BACKGROUND


Balance and functional strength training can improve muscle strength and physical functioning outcomes and decrease the risk of falls in older adults. To maximize the benefits of strength training, adequate protein intake is also important. However, the number of older individuals that consume enough protein or routinely engage in strength training remains low at less than 5% and even lower for activities that challenge balance. Our primary aim was to assess the feasibility of implementing a model (MoveStrong) of service delivery to teach older adults about balance and functional strength training and methods to increase protein intake.
METHODS


This study was a closed cohort stepped wedge randomized controlled trial. We recruited individuals ≥60 years considered pre-frail or frail with at least one chronic condition who were not currently engaging in regular strength training from Northern (rural) and Southern (urban) Ontario sites in Canada. The primary outcome was feasibility of implementation, defined by recruitment, retention, and adherence, and safety (defined by monitoring adverse events). We also reported participants' and providers' experience with MoveStrong, adaptations to the model based on participant's and provider's experience, and program fidelity.
RESULTS


We recruited 44 participants to the study and the average adherence rate was 72% with a retention of 71%. The program had a high-fidelity score. One person experienced a fall-related injury during exercise, while two other participants reported pain during certain activities. Five individuals experienced injuries or health problems that were not related to the program. Suggestions for future trials include modifying some exercises, exploring volunteer assistance, increasing the diversity of participants enrolled, and considering a different study design.
CONCLUSIONS


Our pilot trial demonstrates the feasibility of recruitment and adherence for a larger multisite RCT of balance and functional strength training with attention to protein intake in pre-frail and frail older adults.",2021,"BACKGROUND


Balance and functional strength training can improve muscle strength and physical functioning outcomes and decrease the risk of falls in older adults.","['pre-frail older adults', 'individuals ≥60 years considered pre-frail or frail with at least one chronic condition who were not currently engaging in regular strength training from Northern (rural) and Southern (urban) Ontario sites in Canada', ""participants' and providers' experience with MoveStrong, adaptations to the model based on participant's and provider's experience, and program fidelity"", '44 participants to the study and the average adherence rate was 72% with a retention of 71', 'older adults', 'pre-frail and frail older adults']","['MoveStrong program', 'strength training', 'functional strength training', 'functional strength training with attention to protein intake', 'functional strength training and adequate protein intake']","['muscle strength and physical functioning outcomes', 'injuries or health problems', 'feasibility of implementation, defined by recruitment, retention, and adherence, and safety (defined by monitoring adverse events', 'pain during certain activities']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",44.0,0.0237932,"BACKGROUND


Balance and functional strength training can improve muscle strength and physical functioning outcomes and decrease the risk of falls in older adults.","[{'ForeName': 'Isabel B', 'Initials': 'IB', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Kinesiology and Health, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Kinesiology and Health, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Keller', 'Affiliation': 'Department of Kinesiology and Health, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Maureen C', 'Initials': 'MC', 'LastName': 'Ashe', 'Affiliation': 'Department of Family Practice, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Brien', 'Affiliation': 'Canadian Osteoporosis Patient Network, Osteoporosis Canada, Toronto, ON, Canada.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Funnell', 'Affiliation': 'Canadian Osteoporosis Patient Network, Osteoporosis Canada, Toronto, ON, Canada.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Canadian Osteoporosis Patient Network, Osteoporosis Canada, Toronto, ON, Canada.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Loong', 'Affiliation': ""CLEAR Health Economics, Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Wanrudee', 'Initials': 'W', 'LastName': 'Isaranuwatchai', 'Affiliation': ""CLEAR Health Economics, Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Milligan', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Mourtzakis', 'Affiliation': 'Department of Kinesiology and Health, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Papaioannou', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Straus', 'Affiliation': ""CLEAR Health Economics, Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Zachary J', 'Initials': 'ZJ', 'LastName': 'Weston', 'Affiliation': 'Waterloo Wellington Local Health Integration Network, Waterloo, ON, Canada.'}, {'ForeName': 'Lora M', 'Initials': 'LM', 'LastName': 'Giangregorio', 'Affiliation': 'Department of Kinesiology and Health, University of Waterloo, Waterloo, ON, Canada.'}]",PloS one,['10.1371/journal.pone.0257742']
1646,34559829,What contributes to good outcomes? The perspective of young people on short-term psychoanalytic psychotherapy for depressed adolescents.,"Depression is the fourth leading cause of adolescent illness and disability worldwide. A growing evidence base demonstrates that Short Term Psychoanalytic Psychotherapy [STPP] is an efficacious treatment for moderate to severe adolescent depression. However, with research in its infancy, key factors contributing to efficacy are unknown. Service users' lived experiences provide valuable insight in this area. This study aimed to elucidate what adolescents value in treatment by inductively exploring lived experiences of STPP. Five adolescents with the largest reduction in depressive symptoms scores between baseline and end of treatment, who had taken part in a large-scale randomized controlled trial, were sampled. In-depth interviews carried out soon after the end of therapy were analysed using Interpretative Phenomenological Analysis. Three superordinate themes were identified: ""Therapy as a Transformational Process"", ""Explorative and Exposing: The Therapeutic Space"" and ""Being Heard and Working Together: The Therapeutic Relationship"". Adolescents valued a process of collaborative exploration with the therapist which when it was achieved was felt to facilitate a deep-rooted transformation in self-perception. Additionally, they described how an adjustment was needed to the particular frame of a psychoanalytic therapy. However, not all participants with a good treatment outcome experienced therapy in this way, suggesting a potential gap between the quantitative assessment of outcomes, and the way young people experience and understand the change process. Clinical implications and directions for research are discussed.",2021,A growing evidence base demonstrates that Short Term Psychoanalytic Psychotherapy [STPP] is an efficacious treatment for moderate to severe adolescent depression.,['depressed adolescents'],"['Psychoanalytic Psychotherapy [STPP', 'short-term psychoanalytic psychotherapy']",['depressive symptoms scores'],"[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",5.0,0.069935,A growing evidence base demonstrates that Short Term Psychoanalytic Psychotherapy [STPP] is an efficacious treatment for moderate to severe adolescent depression.,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Housby', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London [UCL], United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Thackeray', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London [UCL], United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London [UCL], United Kingdom.'}]",PloS one,['10.1371/journal.pone.0257334']
1647,34559801,Causes of death after biannual azithromycin treatment: A community-level randomized clinical trial.,"The MORDOR study, a masked, community-level randomized clinical trial conducted in Niger, Malawi and Tanzania (2015 to 2017), showed that biannual administration of single-dose azithromycin to preschool children reduced all-cause mortality. We sought to evaluate its impact on causes of death in children aged 1-59 months in Tanzania. A random sampling of 614 communities was conducted in Kilosa District, Tanzania, with simple random assignment of communities to receive either azithromycin or placebo. In these communities, a census was carried out every 6 months and children aged 1-59 months received biannual (every 6 months), single-dose azithromycin (~20mg/kg) or placebo depending on community assignment, over a 2-year period. Mortality was determined at the time of the biannual census. For child deaths, a verbal autopsy was performed to ascertain the cause using a standardized diagnostic classification. A total of 190- (0.58 /100 person-years) and 200 deaths (0.59/100 person-years) were reported in the azithromycin and placebo arms, respectively. Malaria, pneumonia and diarrhea, accounted for 71% and 68% of deaths in the respective arms. Overall, the mortality was not different by treatment arm, nor were the distribution of causes of death after adjusting for community clustering. The cause-specific mortality for diarrhea/pneumonia was no different over time. In children aged 1-5 months, 32 deaths occurred in the placebo arm and 25 deaths occurred in the azithromycin arm; 20 (62.5%) deaths in the placebo- and 10 (40%) in the azithromycin arm were attributed to diarrhea or pneumonia. Neither differences in the number of deaths nor the diarrhea/pneumonia attribution was statistically significant after adjusting for community clustering. In conclusion, azithromycin was not associated with a significant decline in deaths by specific causes compared to placebo. The non-significant lower rates of diarrhea or pneumonia in children <6 months who received azithromycin merit further investigation in high-mortality settings. Trial registration: NCT02048007.",2021,The non-significant lower rates of diarrhea or pneumonia in children <6 months who received azithromycin merit further investigation in high-mortality settings.,"['614 communities was conducted in Kilosa District, Tanzania, with simple random assignment of communities to receive either', 'children aged 1-59 months in Tanzania']","['azithromycin', 'azithromycin and placebo', 'azithromycin or placebo', 'Malawi and Tanzania', 'placebo']","['mortality', 'cause-specific mortality for diarrhea/pneumonia', 'Malaria, pneumonia and diarrhea', 'deaths', 'number of deaths nor the diarrhea/pneumonia attribution', 'Mortality', 'diarrhea or pneumonia']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.485144,The non-significant lower rates of diarrhea or pneumonia in children <6 months who received azithromycin merit further investigation in high-mortality settings.,"[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of pathology, Johns Hopkins School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Kilosa, Tanzania.'}, {'ForeName': 'Jerusha', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, MD, United States of America.'}]",PloS one,['10.1371/journal.pone.0250197']
1648,34537218,Emergency severity level-3 patient flow based on point-of-care testing improves patient outcomes.,"BACKGROUND


Overcrowding of the Emergency Department is rapidly becoming a global challenge and a major source of concern for emergency physicians. The desire to improve Emergency Department throughput requires novel approaches to patient flow.
MATERIALS AND METHODS


We conducted a prospective and cluster-randomized study, to evaluate the impact in patient outcomes of a new patient flow based on Point-of-Care Testing (POCT). A total of 380 Emergency Severity Level-3 patients were enrolled and studied in two different groups, interventional arm (laboratory analyses performed on POCT analyzers implemented in the Emergency Department) or control arm (central laboratory). The primary outcome was the Emergency Department length of stay. Secondary outcome included the time to first medical intervention, the laboratory turnaround time and the time to disposition decision. Readmission within the 7 days after discharge was also calculated.
RESULTS


Length of stay significantly decreased by 88.50 min (from 247.00 to 158.50), time to disposition decision by 89.00 min (from 192.00 to 103.00) and laboratory turnaround time by 67.11 min (from 89.84 to 22.73) in the POCT group. No increase in readmission was found.
CONCLUSION


Our strategy based on POCT represents a good approach to optimize patient flow in the Emergency Department and it should be seen as a starting point for further studies focusing on improving throughput.",2021,"RESULTS


Length of stay significantly decreased by 88.50 min (from 247.00 to 158.50), time to disposition decision by 89.00 min (from 192.00 to 103.00) and laboratory turnaround time by 67.11 min (from 89.84 to 22.73) in the POCT group.","['380 Emergency Severity Level-3 patients were enrolled and studied in two different groups, interventional arm (laboratory analyses performed on POCT analyzers implemented in the Emergency Department) or control arm (central laboratory']",['new patient flow based on Point-of-Care Testing (POCT'],"['time to first medical intervention, the laboratory turnaround time and the time to disposition decision', 'Readmission', 'readmission', 'Emergency Department length of stay', 'time to disposition decision', 'laboratory turnaround time', 'Length of stay']","[{'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",380.0,0.0786609,"RESULTS


Length of stay significantly decreased by 88.50 min (from 247.00 to 158.50), time to disposition decision by 89.00 min (from 192.00 to 103.00) and laboratory turnaround time by 67.11 min (from 89.84 to 22.73) in the POCT group.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jimenez-Barragan', 'Affiliation': 'Laboratory Medicine Department Macarena University Hospital, Dr. Fedriani n°3, 41009 Seville, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodriguez-Oliva', 'Affiliation': 'Laboratory Medicine Department Macarena University Hospital, Dr. Fedriani n°3, 41009 Seville, Spain.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Sanchez-Mora', 'Affiliation': 'Laboratory Medicine Department Macarena University Hospital, Dr. Fedriani n°3, 41009 Seville, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Navarro-Bustos', 'Affiliation': 'Emergency Department Macarena University Hospital, Dr. Fedriani n°3, 41009 Seville, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Fuentes-Cantero', 'Affiliation': 'Laboratory Medicine Department Macarena University Hospital, Dr. Fedriani n°3, 41009 Seville, Spain.'}, {'ForeName': 'Salomon', 'Initials': 'S', 'LastName': 'Martin-Perez', 'Affiliation': 'Laboratory Medicine Department Macarena University Hospital, Dr. Fedriani n°3, 41009 Seville, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Garrido-Castilla', 'Affiliation': 'Emergency Department Macarena University Hospital, Dr. Fedriani n°3, 41009 Seville, Spain.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Undabeytia-Lopez', 'Affiliation': 'Emergency Department Macarena University Hospital, Dr. Fedriani n°3, 41009 Seville, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Luque-Cid', 'Affiliation': 'Laboratory Medicine Department Macarena University Hospital, Dr. Fedriani n°3, 41009 Seville, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'de Miguel-Melendez', 'Affiliation': 'Laboratory Medicine Department Macarena University Hospital, Dr. Fedriani n°3, 41009 Seville, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Leon-Justel', 'Affiliation': 'Laboratory Medicine Department Macarena University Hospital, Dr. Fedriani n°3, 41009 Seville, Spain. Electronic address: antonio.leonj.sspa@juntadeandalucia.es.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2021.09.011']
1649,34562564,Randomized double-blind trial comparing low dose and conventional dose of a modified traditional herbal formula Guizhi Fuling Wan in women with symptomatic uterine fibroids.,"ETHNOPHARMACOLOGICAL RELEVANCE


The herbal formula Guizhi Fuling Wan is one common remedy for treating uterine fibroids (UFs) and the relevant symptoms in Traditional Chinese Medicine (TCM). Previous systematic reviews showed that Guizhi Fuling Formula appeared to have additional benefit based on mifepristone treatment in reducing volume of fibroids.
AIM OF STUDY


To study the efficacy and safety of the conventional dose of a modified herbal formula Guizhi Fuling Wan in patients with symptomatic uterine fibroids in comparison with a sub-effective dose control.
MATERIALS AND METHODS


This randomized double-blind, dosage-controlled trial was carried out in an outpatient clinic of traditional Chinese medicine in Hong Kong. Women with symptomatic uterine fibroids diagnosed according to the WHO International Classification of Diseases (ICD-10) were recruited and randomly assigned to one of two groups that received modified Guizhi Fuling Wan at either a low dose or the conventional dose on a daily basis for 16 weeks. This study was quality controlled by a data safety monitoring board. The primary outcome was the symptom severity as measured with the Uterine Fibroid Symptom-Quality of Life questionnaire. The secondary outcomes included quality of life, menstrual bleeding (measured on a pictorial blood loss assessment chart), pain severity (measured on the 6-point behavioral rating scale), change in Chinese medicine syndrome score, fibroid volume (measured by magnetic resonance imaging), hemoglobin level, and hormone levels.
RESULTS


Seventy-eight women were recruited for this study. Between-groups comparison showed no significant difference at the endpoint for all outcomes except for the Chinese medicine syndrome score; however, at the endpoint, within-group comparison showed significant improvement in both groups relative to baseline in symptom severity, functional influence of pelvic pain, Chinese medicine syndrome score, and fibroid volume and uterus condition on magnetic resonance imaging (p < 0.05).The low-dose group yielded greater endpoint improvement in the Chinese medicine syndrome score than the conventional-dose group (p=0.024). No serious adverse events related to the intervention were noted.
CONCLUSION


Both low-dose and conventional-dose preparations significantly ameliorated uterine fibroid-related symptoms and fibroid volume, although no significant difference was found between the low-dose and conventional-dose groups. The herbal formula GuizhiFuling Wan is safe in women with uterine fibroids.",2022,"Between-groups comparison showed no significant difference at the endpoint for all outcomes except for the Chinese medicine syndrome score; however, at the endpoint, within-group comparison showed significant improvement in both groups relative to baseline in symptom severity, functional influence of pelvic pain, Chinese medicine syndrome score, and fibroid volume and uterus condition on magnetic resonance imaging (p < 0.05).The low-dose group yielded greater endpoint improvement in the Chinese medicine syndrome score than the conventional-dose group (p=0.024).","['outpatient clinic of traditional Chinese medicine in Hong Kong', 'patients with symptomatic uterine fibroids in comparison with a sub-effective dose control', 'women with uterine fibroids', 'women with symptomatic uterine fibroids', 'Women with symptomatic uterine fibroids diagnosed according to the WHO International Classification of Diseases (ICD-10', 'Seventy-eight women were recruited for this study']","['herbal formula', 'modified herbal formula Guizhi Fuling Wan', 'modified Guizhi Fuling Wan at either a low dose or the conventional dose', 'mifepristone']","['quality of life, menstrual bleeding (measured on a pictorial blood loss assessment chart), pain severity (measured on the 6-point behavioral rating scale), change in Chinese medicine syndrome score, fibroid volume (measured by magnetic resonance imaging), hemoglobin level, and hormone levels', 'uterine fibroid-related symptoms and fibroid volume', 'symptom severity as measured with the Uterine Fibroid Symptom-Quality of Life questionnaire', 'efficacy and safety', 'Chinese medicine syndrome score', 'symptom severity, functional influence of pelvic pain, Chinese medicine syndrome score, and fibroid volume and uterus condition on magnetic resonance imaging']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1034610', 'cui_str': 'Fu Ling'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0475483', 'cui_str': 'Behavior rating scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",78.0,0.246049,"Between-groups comparison showed no significant difference at the endpoint for all outcomes except for the Chinese medicine syndrome score; however, at the endpoint, within-group comparison showed significant improvement in both groups relative to baseline in symptom severity, functional influence of pelvic pain, Chinese medicine syndrome score, and fibroid volume and uterus condition on magnetic resonance imaging (p < 0.05).The low-dose group yielded greater endpoint improvement in the Chinese medicine syndrome score than the conventional-dose group (p=0.024).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Meng', 'Affiliation': ""School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong; Hong Kong Branch of Zhu's School of Gynecology of Chinese Medicine from Shanghai Workstation of Zhu Nansun, National Master of Chinese Medicine, School of Chinese Medicine, The University of Hong Kong, Hong Kong; Hong Kong Branch of Yu Jin, Masters of Gynaecology of Integrative Medicine, Workstations for Training and Research, Hong Kong. Electronic address: bmeng@hku.hk.""}, {'ForeName': 'Wai Ling', 'Initials': 'WL', 'LastName': 'Lin', 'Affiliation': 'Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Hong Kong. Electronic address: wllin@cuhk.edu.hk.'}, {'ForeName': 'Wing Fai', 'Initials': 'WF', 'LastName': 'Yeung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong. Electronic address: jerry-wf.yeung@polyu.edu.hk.'}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong. Electronic address: ybzhang@hku.hk.'}, {'ForeName': 'Ernest Hung Yu', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': 'Department of Obstetrics and Gynecology, Queen Mary Hospital, The University of Hong Kong, Hong Kong. Electronic address: nghye@hku.hk.'}, {'ForeName': 'Yuen Phin Elaine', 'Initials': 'YPE', 'LastName': 'Lee', 'Affiliation': 'Department of Diagnostic Radiology, Queen Mary Hospital, The University of Hong Kong, Hong Kong. Electronic address: eyplee77@hku.hk.'}, {'ForeName': 'Zhang-Jin', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong; Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China; Department of Chinese Medicine, Gleneagles Hospital, Hong Kong. Electronic address: zhangzj@hku.hk.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Rong', 'Affiliation': 'School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong. Electronic address: jrong@hku.hk.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong; Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China; Virginia University of Integrative Medicine, Fairfax, USA. Electronic address: llao@vuim.edu.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2021.114676']
1650,34530172,The effect of denosumab and alendronate on trabecular plate and rod microstructure at the distal tibia and radius: A post-hoc HR-pQCT study.,"BACKGROUND


Age-related trabecular microstructural deterioration and conversion from plate-like trabeculae to rod-like trabeculae occur because of unbalanced rapid remodeling. As denosumab achieves greater remodeling suppression and lower cortical porosity than alendronate, we hypothesized that denosumab might also preserve trabecular plate microstructure, bone stiffness and strength more effectively than alendronate.
METHODS


In this post hoc analysis of a phase 2 study, postmenopausal women randomized to placebo (P, n = 74), denosumab (D, n = 72), or alendronate (A, n = 68). HR-pQCT scans of the distal radius and tibia were performed at baseline and Month-12 (M12). Trabecular compartment was subjected to Individual Trabecula Segmentation while finite element analysis was performed to estimate stiffness and strength. Percent change from baseline at M12 of each parameter was compared between patient groups.
RESULTS


At the distal tibia, in the placebo group, plate surface area (pTb.S, -1.3%) decreased while rod bone volume fraction (rBV/TV, +4.5%) and number (rTb.N, +2.1%) increased. These changes were prevented by denosumab but persisted despite alendronate therapy (pTb.S: -1.7%; rBV/TV: +6.9%; rTb.N: +3.0%). Both treatments improved whole bone stiffness (D: +3.1%; A: +1.8%) and failure load (D: +3.0%; A: +2.2%); improvements using denosumab was significant compared to placebo (stiffness: p = 0.004; failure load: p = 0.003). At the distal radius, denosumab increased total trabecular bone volume fraction (BV/TV, +3.4%) and whole bone failure load (+4.0%), significantly different from placebo (BV/TV: p = 0.044; failure load: p = 0.046). Significantly different effects of either drug on plate and rod microstructure were not detected.
CONCLUSIONS


Denosumab preserved trabecular plate microstructure. Alendronate did not. However, estimated strength did not differ between denosumab and alendronate treated groups.",2021,"At the distal radius, denosumab increased total trabecular bone volume fraction (BV/TV, +3.4%) and whole bone failure load (+4.0%), significantly different from placebo (BV/TV:",[],"['denosumab (D, n\xa0=\xa072), or alendronate', 'placebo (BV/TV', 'alendronate', 'placebo', 'denosumab and alendronate', 'Alendronate']","['whole bone failure load', 'trabecular plate microstructure', 'total trabecular bone volume fraction', 'rod bone volume fraction', 'estimated strength', 'plate and rod microstructure', 'trabecular plate and rod microstructure', 'failure load', 'whole bone stiffness']",[],"[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0035086', 'cui_str': 'Renal osteodystrophy'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",,0.106864,"At the distal radius, denosumab increased total trabecular bone volume fraction (BV/TV, +3.4%) and whole bone failure load (+4.0%), significantly different from placebo (BV/TV:","[{'ForeName': 'Yizhong Jenny', 'Initials': 'YJ', 'LastName': 'Hu', 'Affiliation': 'Bone Bioengineering Laboratory, Department of Biomedical Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Ego', 'Initials': 'E', 'LastName': 'Seeman', 'Affiliation': 'Departments of Endocrinology and Medicine, Austin Health, University of Melbourne, Melbourne, Australia; Mary MacKillop Institute of Healthy Aging, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'X Edward', 'Initials': 'XE', 'LastName': 'Guo', 'Affiliation': 'Bone Bioengineering Laboratory, Department of Biomedical Engineering, Columbia University, New York, NY, USA. Electronic address: ed.guo@columbia.edu.'}]",Bone,['10.1016/j.bone.2021.116187']
1651,34570180,Effect of Methylphenidate on Apathy in Patients With Alzheimer Disease: The ADMET 2 Randomized Clinical Trial.,"Importance


Apathy, characterized by diminished will or initiative and one of the most prevalent neuropsychiatric symptoms in individuals with Alzheimer disease, is associated with significant caregiver burden, excess disability, increased medical costs, and mortality.
Objective


To measure whether methylphenidate compared with placebo decreases the severity of apathy in individuals with Alzheimer disease.
Design, Setting, and participants


This multicenter randomized placebo-controlled clinical trial was conducted from August 2016 to July 2020 in 9 US clinics and 1 Canadian clinic specializing in dementia care. A total of 307 potential participants were screened. Of those, 52 did not pass screening and 55 were not eligible. Participants with Alzheimer disease, mild to moderate cognitive impairment, and frequent and/or severe apathy as measured by the Neuropsychiatric Inventory (NPI) were included.
Interventions


Ten milligrams of methylphenidate, twice daily, vs matching placebo.
Main Outcomes and Measures


The coprimary outcomes included (1) change from baseline to 6 months in the NPI apathy subscale or (2) improved rating on the Alzheimer's Disease Cooperative Study Clinical Global Impression of Change. Other outcomes include safety, change in cognition, and quality of life.
Results


Of 200 participants, 99 were assigned to methylphenidate and 101 to placebo. The median (interquartile range) age of study participants was 76 (71-81) years; 68 (34%) were female and 131 (66%) were male. A larger decrease was found from baseline to 6 months in the NPI apathy score in those receiving methylphenidate compared with placebo (mean difference, -1.25; 95% CI, -2.03 to -0.47; P = .002). The largest decrease in the NPI apathy score was observed in the first 100 days, with a significant hazard ratio for the proportion of participants with no apathy symptoms receiving methylphenidate compared with placebo (hazard ratio, 2.16; 95% CI, 1.19-3.91; P = .01). At 6 months, the odds ratio of having an improved rating on the Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for methylphenidate compared with placebo was 1.90 (95% CI, 0.95-3.84; P = .07). The difference in mean change from baseline to 6 months estimated using a longitudinal model was 1.43 (95% CI, 1.00-2.04; P = .048). Cognitive measures and quality of life were not significantly different between groups. Of the 17 serious adverse events that occurred during the study, none were related to the study drug. No significant differences in the safety profile were noted between treatment groups.
Conclusions and Relevance


This study found methylphenidate to be a safe and efficacious medication to use in the treatment of apathy in Alzheimer disease.
Trial Registration


ClinicalTrials.gov Identifier: NCT02346201.",2021,"A larger decrease was found from baseline to 6 months in the NPI apathy score in those receiving methylphenidate compared with placebo (mean difference, -1.25; 95% CI, -2.03 to -0.47; P = .002).","['August 2016 to July 2020 in 9 US clinics and 1 Canadian clinic specializing in dementia care', 'individuals with Alzheimer disease', 'Participants with Alzheimer disease, mild to moderate cognitive impairment, and frequent and/or severe apathy as measured by the Neuropsychiatric Inventory (NPI) were included', 'Patients With Alzheimer Disease', 'The median (interquartile range) age of study participants was 76 (71-81) years; 68 (34%) were female and 131 (66%) were male', '200 participants', '307 potential participants were screened']","['placebo', 'methylphenidate', 'Methylphenidate']","[""odds ratio of having an improved rating on the Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for methylphenidate"", 'safety profile', 'Cognitive measures and quality of life', 'safety, change in cognition, and quality of life', 'severity of apathy', ""NPI apathy subscale or (2) improved rating on the Alzheimer's Disease Cooperative Study Clinical Global Impression of Change"", 'NPI apathy score']","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",307.0,0.93663,"A larger decrease was found from baseline to 6 months in the NPI apathy score in those receiving methylphenidate compared with placebo (mean difference, -1.25; 95% CI, -2.03 to -0.47; P = .002).","[{'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Mintzer', 'Affiliation': 'Ralph H. Johnson VA Medical Center, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Lanctôt', 'Affiliation': 'Sunnybrook Research Institute, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Roberta W', 'Initials': 'RW', 'LastName': 'Scherer', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Rosenberg', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Sunnybrook Research Institute, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'van Dyck', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Prasad R', 'Initials': 'PR', 'LastName': 'Padala', 'Affiliation': 'Central Arkansas Veterans Healthcare System, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Brawman-Mintzer', 'Affiliation': 'Ralph H. Johnson VA Medical Center, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Anton P', 'Initials': 'AP', 'LastName': 'Porsteinsson', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Lerner', 'Affiliation': 'University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Allan I', 'Initials': 'AI', 'LastName': 'Levey', 'Affiliation': ""Emory Goizueta Alzheimer's Disease Research Center, Atlanta, Georgia.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Burke', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shade', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2021.3356']
1652,34570177,Effect of Levetiracetam on Cognition in Patients With Alzheimer Disease With and Without Epileptiform Activity: A Randomized Clinical Trial.,"Importance


Network hyperexcitability may contribute to cognitive dysfunction in patients with Alzheimer disease (AD).
Objective


To determine the ability of the antiseizure drug levetiracetam to improve cognition in persons with AD.
Design, Setting, and Participants


The Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability (LEV-AD) study was a phase 2a randomized double-blinded placebo-controlled crossover clinical trial of 34 adults with AD that was conducted at the University of California, San Francisco, and the University of Minnesota, Twin Cities, between October 16, 2014, and July 21, 2020. Participants were adults 80 years and younger who had a Mini-Mental State Examination score of 18 points or higher and/or a Clinical Dementia Rating score of less than 2 points. Screening included overnight video electroencephalography and a 1-hour resting magnetoencephalography examination.
Interventions


Group A received placebo twice daily for 4 weeks followed by a 4-week washout period, then oral levetiracetam, 125 mg, twice daily for 4 weeks. Group B received treatment using the reverse sequence.
Main Outcomes and Measures


The primary outcome was the ability of levetiracetam treatment to improve executive function (measured by the National Institutes of Health Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research [NIH-EXAMINER] composite score). Secondary outcomes were cognition (measured by the Stroop Color and Word Test [Stroop] interference naming subscale and the Alzheimer's Disease Assessment Scale-Cognitive Subscale) and disability. Exploratory outcomes included performance on a virtual route learning test and scores on cognitive and functional tests among participants with epileptiform activity.
Results


Of 54 adults assessed for eligibility, 11 did not meet study criteria, and 9 declined to participate. A total of 34 adults (21 women [61.8%]; mean [SD] age, 62.3 [7.7] years) with AD were enrolled and randomized (17 participants to group A and 17 participants to group B). Thirteen participants (38.2%) were categorized as having epileptiform activity. In total, 28 participants (82.4%) completed the study, 10 of whom (35.7%) had epileptiform activity. Overall, treatment with levetiracetam did not change NIH-EXAMINER composite scores (mean difference vs placebo, 0.07 points; 95% CI, -0.18 to 0.32 points; P = .55) or secondary measures. However, among participants with epileptiform activity, levetiracetam treatment improved performance on the Stroop interference naming subscale (net improvement vs placebo, 7.4 points; 95% CI, 0.2-14.7 points; P = .046) and the virtual route learning test (t = 2.36; Cohen f2 = 0.11; P = .02). There were no treatment discontinuations because of adverse events.
Conclusions and Relevance


In this randomized clinical trial, levetiracetam was well tolerated and, although it did not improve the primary outcome, in prespecified analysis, levetiracetam improved performance on spatial memory and executive function tasks in patients with AD and epileptiform activity. These exploratory findings warrant further assessment of antiseizure approaches in AD.
Trial Registration


ClinicalTrials.gov Identifier: NCT02002819.",2021,"However, among participants with epileptiform activity, levetiracetam treatment improved performance on the Stroop interference naming subscale (net improvement vs placebo, 7.4 points; 95% CI, 0.2-14.7 points; P = .046) and the virtual route learning test (t = 2.36; Cohen f2 = 0.11; P = .02).","['34 adults with AD that was conducted at the University of California, San Francisco, and the University of Minnesota, Twin Cities, between October 16, 2014, and July 21, 2020', 'participants with epileptiform activity', '34 adults (21 women [61.8%]; mean [SD] age, 62.3 [7.7] years) with AD were enrolled and randomized (17 participants to group A and 17 participants to group B', 'patients with Alzheimer disease (AD', 'Patients With Alzheimer Disease', ""Participants\n\n\nThe Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability (LEV-AD"", 'Participants were adults 80 years and younger who had a Mini-Mental State Examination score of 18 points or higher and/or a Clinical Dementia Rating score of less than 2 points', 'persons with AD', 'patients with AD and epileptiform activity']","['antiseizure drug levetiracetam', 'overnight video electroencephalography and a 1-hour resting magnetoencephalography examination', 'levetiracetam', 'placebo', 'Levetiracetam']","['epileptiform activity', 'performance on a virtual route learning test and scores on cognitive and functional tests', 'change NIH-EXAMINER composite scores', 'ability of levetiracetam treatment to improve executive function (measured by the National Institutes of Health Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research', 'virtual route learning test', ""cognition (measured by the Stroop Color and Word Test [Stroop] interference naming subscale and the Alzheimer's Disease Assessment Scale-Cognitive Subscale) and disability"", 'performance on the Stroop interference naming subscale', 'spatial memory and executive function tasks']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0856984', 'cui_str': 'Hyperexcitation'}, {'cui': 'C0023556', 'cui_str': 'Levamisole'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4304227', 'cui_str': 'CDR (Clinical Dementia Rating) score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0814087', 'cui_str': 'Spatial Memory'}]",34.0,0.948436,"However, among participants with epileptiform activity, levetiracetam treatment improved performance on the Stroop interference naming subscale (net improvement vs placebo, 7.4 points; 95% CI, 0.2-14.7 points; P = .046) and the virtual route learning test (t = 2.36; Cohen f2 = 0.11; P = .02).","[{'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Vossel', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Kamalini G', 'Initials': 'KG', 'LastName': 'Ranasinghe', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Beagle', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'La', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Kasey', 'Initials': 'K', 'LastName': 'Ah Pook', 'Affiliation': 'N. Bud Grossman Center for Memory Research and Care, Department of Neurology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Madelyn', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'N. Bud Grossman Center for Memory Research and Care, Department of Neurology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mizuiri', 'Affiliation': 'Biomagnetic Imaging Laboratory, Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Honma', 'Affiliation': 'Biomagnetic Imaging Laboratory, Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Venkateswaran', 'Affiliation': 'N. Bud Grossman Center for Memory Research and Care, Department of Neurology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Koestler', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Minnesota Epilepsy Group, St Paul, Minnesota.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Mucke', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Howell', 'Affiliation': 'Department of Neurology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Possin', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Joel H', 'Initials': 'JH', 'LastName': 'Kramer', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Boxer', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Miller', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Srikantan S', 'Initials': 'SS', 'LastName': 'Nagarajan', 'Affiliation': 'Biomagnetic Imaging Laboratory, Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Kirsch', 'Affiliation': 'Biomagnetic Imaging Laboratory, Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco.'}]",JAMA neurology,['10.1001/jamaneurol.2021.3310']
1653,34570042,Exercise Training and Cognitive Function in Kidney Disease: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND


Chronic kidney disease (CKD) is extremely common in older adults and is associated with cognitive impairment. It is hypothesized that accelerated cognitive decline in CKD results from a vascular, dysfunction-induced reduction in the integrity of the brain white matter.
OBJECTIVE


To describe the protocol for a study to evaluate whether exercise training provides a cerebro-protective effect by improving cerebrovascular health.
METHODS


This is a randomized, controlled trial investigating feasibility and effect size.
RESULTS


Participants will be randomized to either a 24-week, home-based, walking program or a usual care group. Participants will undergo evaluation of cognitive function, brain structure via magnetic reasoning imaging, physical function, physical activity, and vascular function. The primary outcome is change in cognitive function.
DISCUSSION


The findings of this study will help determine whether exercise training influences cognitive function during a therapeutic window in the disease process of cognitive impairment in older adults with CKD.
CONCLUSION


This protocol describes a study to evaluate cognition and brain structure following a home-based exercise program to an at-risk population.",2021,"RESULTS


Participants will be randomized to either a 24-week, home-based, walking program or a usual care group.","['older adults', 'older adults with CKD', 'Kidney Disease']","['exercise training', 'Exercise Training', 'walking program or a usual care group']","['cognitive function, brain structure via magnetic reasoning imaging, physical function, physical activity, and vascular function', 'change in cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0456004,"RESULTS


Participants will be randomized to either a 24-week, home-based, walking program or a usual care group.","[{'ForeName': 'Ulf G', 'Initials': 'UG', 'LastName': 'Bronas', 'Affiliation': ""University of Illinois Chicago, College of Nursing, Chicago, IL University of Illinois Chicago, College of Medicine, Chicago, IL Rush University, Rush Alzheimer's Disease Center, Chicago, IL.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hannan', 'Affiliation': ''}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Lash', 'Affiliation': ''}, {'ForeName': 'Olu', 'Initials': 'O', 'LastName': 'Ajilore', 'Affiliation': ''}, {'ForeName': 'Xiaohong Joe', 'Initials': 'XJ', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Lamar', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000554']
1654,34569839,"Protocol for the Rhode Island CORD 3.0 Study: Adapting, Testing, and Packaging the  JOIN for ME  Family-Based Childhood Obesity Program in Low-Income Communities.","Background:  Overweight and obesity in children is a public health crisis in the United States. Although evidence-based interventions have been developed, such programs are difficult to access. Dissemination of evidence-based pediatric weight management interventions (PWMIs) to families from diverse low-income communities is the primary objective of the CDC Childhood Obesity Research Demonstration (CORD) projects.  Methods:  The goal of the Rhode Island CORD 3.0 project is to adapt the evidence-based PWMI,  JOIN for ME , for delivery among diverse families from low-income backgrounds and to test it in a hybrid effectiveness-implementation trial design in which the aims are to examine implementation and patient-centered outcomes. Children between the ages of 6 and 12 years with BMI ≥85th percentile and a caregiver will be recruited through two settings, a federally qualified health center, which serves as a patient-centered medical home, or low-income housing. Dyads will receive a remotely delivered group-based intervention that is 10 months in duration and includes 16 weekly sessions, followed by 4 biweekly and 4 monthly meetings. Assessments of child and caregiver weight status and child health-related quality of life will be conducted at baseline, and at 4 and 10 months after the start of intervention. Implementation outcomes assessing intervention acceptability, adoption, feasibility, fidelity, and penetration/reach will be collected to inform subsequent dissemination.  Conclusions:  If the adapted version of the  JOIN for ME  intervention can be successfully implemented and is shown to be effective, this project will provide a model for a scalable PWMI for families from low-income backgrounds. ClinicalTrials.gov no. NCT04647760.",2021,"If the adapted version of the  JOIN for ME  intervention can be successfully implemented and is shown to be effective, this project will provide a model for a scalable PWMI for families from low-income backgrounds.","['Children between the ages of 6 and 12 years with BMI ≥85th percentile and a caregiver will be recruited through two settings, a federally qualified health center, which serves as a patient-centered medical home, or low-income housing']",['pediatric weight management interventions (PWMIs'],"['intervention acceptability, adoption, feasibility, fidelity, and penetration/reach will be collected to inform subsequent dissemination', 'Assessments of child and caregiver weight status and child health-related quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2713310', 'cui_str': 'Medical Home'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0020056', 'cui_str': 'Housed'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.122599,"If the adapted version of the  JOIN for ME  intervention can be successfully implemented and is shown to be effective, this project will provide a model for a scalable PWMI for families from low-income backgrounds.","[{'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Evans', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Darling', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Seifer', 'Affiliation': 'Frank Porter Graham Child Development Institute, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vivier', 'Affiliation': 'School of Public Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Goldberg', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Medford, MA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wright', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Medford, MA, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Tanskey', 'Affiliation': 'Eva Garland Consulting, Raleigh, NC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Warnick', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hayes', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Shepard', 'Affiliation': 'Heller School of Social Policy and Management, Brandeis University, Waltham, MA, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Tuttle', 'Affiliation': 'Rally Health, Minneapolis, MN, USA.'}, {'ForeName': 'A Rani', 'Initials': 'AR', 'LastName': 'Elwy', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.'}]",Childhood obesity (Print),['10.1089/chi.2021.0179']
1655,34569426,Application of hepatitis B immunoglobulin in prevention of mother-to-child transmission of chronic hepatitis B in HBsAg- and HBeAg-positive mother.,"The aim of our study was to compare the efficacy of two dosages of hepatitis B immunoglobulin (HBIG) combined with HBV vaccine (HBVac) to prevent mother-to-child transmission (MTCT) of hepatitis B in HBsAg- and HBeAg-positive mother. We enrolled 331 mother-infant pairs with HBsAg- and HBeAg-positive maternal state from the Women's Hospital School of Medicine of Zhejiang University. Newborns were randomly distributed into two groups according to the dosages of HBIG injection: 100 IU and 200 IU. Newborns from both groups were injected with HBVac in the same doses. We compared the immune outcomes between the two groups and explore the influencing factors of immune outcomes through regression analysis. There was no statistically significant relationship between HBsAg serological transmission of newborns and dosages of HBIG in HBsAg- and HBeAg-positive mother ( p >  .05). The Logistic regression showed that high DNA load is a risk factor for passive-active immunoprophylaxis failure for both 100 IU and 200 IU group, but higher-dosage HBIG is not necessary for higher-viral-load pregnant women with HBsAg- and HBeAg-positive. In conclusion, combined application of HBVac and a single dose of 100 IU HBIG can achieve the ideal MTCT interruption results for HBsAg- and HBeAg-positive pregnant women.IMPACT STATEMENT What is already known on this subject?  Passive-active immunoprophylaxis is proved to be effective in preventing mother-to-child transmission of hepatitis B. Hepatitis B vaccine combined with 100 IU or 200 IU immunoglobulin is mostly recommended in China. What do the results of this study add?  At present, there is still a lack scientific basis for improving existing strategies and measures to prevent mother-to-child transmission of hepatitis B in China. What are the implications of these findings for clinical practice and/or further research?  100 IU and 200 IU immunoglobulin show equivalent blocking effect, and combined use of hepatitis B vaccine and 100 IU immunoglobulin is more cost-effective.",2021,"The Logistic regression showed that high DNA load is a risk factor for passive-active immunoprophylaxis failure for both 100 IU and 200 IU group, but higher-dosage HBIG is not necessary for higher-viral-load pregnant women with HBsAg- and HBeAg-positive.","['Newborns', ""We enrolled 331 mother-infant pairs with HBsAg- and HBeAg-positive maternal state from the Women's Hospital School of Medicine of Zhejiang University""]","['hepatitis B vaccine and 100\u2009IU immunoglobulin', 'IMPACT', 'hepatitis B immunoglobulin', 'hepatitis B immunoglobulin (HBIG) combined with HBV vaccine (HBVac']",[],"[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0062525', 'cui_str': 'hepatitis B immune globulin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],331.0,0.0663659,"The Logistic regression showed that high DNA load is a risk factor for passive-active immunoprophylaxis failure for both 100 IU and 200 IU group, but higher-dosage HBIG is not necessary for higher-viral-load pregnant women with HBsAg- and HBeAg-positive.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics, Zhejiang University School of Medicine Women's Hospital, Hangzhou, China.""}, {'ForeName': 'Jia Wei', 'Initials': 'JW', 'LastName': 'Fang', 'Affiliation': 'School of Public Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Zhao Wen', 'Initials': 'ZW', 'LastName': 'Gu', 'Affiliation': 'Department of Clinical Medicine, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Dong Jie', 'Initials': 'DJ', 'LastName': 'Song', 'Affiliation': 'Department of Clinical Medicine, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Obstetrics, Zhejiang University School of Medicine Women's Hospital, Hangzhou, China.""}, {'ForeName': 'Guang Di', 'Initials': 'GD', 'LastName': 'Chen', 'Affiliation': 'School of Public Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Baihui', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': ""Department of Obstetrics, Zhejiang University School of Medicine Women's Hospital, Hangzhou, China.""}, {'ForeName': 'Ce', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': ""Department of Obstetrics, Zhejiang University School of Medicine Women's Hospital, Hangzhou, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Obstetrics, Zhejiang University School of Medicine Women's Hospital, Hangzhou, China.""}, {'ForeName': 'Ke Xin', 'Initials': 'KX', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Medicine, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jia Qi', 'Initials': 'JQ', 'LastName': 'Shen', 'Affiliation': 'Department of Clinical Medicine, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xiao Fu', 'Initials': 'XF', 'LastName': 'Yang', 'Affiliation': ""Department of Obstetrics, Zhejiang University School of Medicine Women's Hospital, Hangzhou, China.""}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': ""Department of Obstetrics, Zhejiang University School of Medicine Women's Hospital, Hangzhou, China.""}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2021.1946495']
1656,34569052,"Duration of skin desensitisation following palmar digital nerve blocks with lidocaine, bupivacaine, mepivacaine and prilocaine.","Objective comparative evidence of the time to onset and duration of effect provided by local anaesthetic (LA) agents for perineural blocks in the horse is lacking. Clear knowledge of these properties is required to guide clinically appropriate agent selection and aid interpretation of response to diagnostic blocks for lameness examinations. An interventional study, with complete, randomised crossover design was used to compare time to onset and duration of skin desensitisation provided by four LA agents applied to palmar digital nerve blocks in 12 horses. Effect at each time point was determined using a pressure gauge to measure the mechanical nociceptive threshold (MNT) over the heel bulbs. Complete desensitisation was defined when MNT was greater than four times the pre-block baseline. Onset and duration of complete desensitisation were recorded and compared across agents using a mixed linear model. When significant (P ≤ 0.05), post-hoc paired comparisons between agents were performed against a Tukey's corrected P ≤ 0.05. Onset of complete skin desensitisation for each agent was <5 min. Duration for lidocaine (mean 25 min; 95% confidence interval [CI] 9-42) was shorter than bupivacaine (53 min; 95% CI 39-65), which was shorter than both prilocaine (102 min; 95% CI 81-123) and mepivacaine (107 min; 95% CI 92-121), which were not different. Although onset of complete skin desensitisation was not different for the LA agents tested, duration varied from 25 min to nearly 2 h. Prilocaine and mepivacaine provided the most prolonged duration of effect, both exceeding bupivacaine.",2021,"Duration for lidocaine (mean 25 min; 95% confidence interval [CI] 9-42) was shorter than bupivacaine (53 min; 95% CI 39-65), which was shorter than both prilocaine (102 min; 95% CI 81-123) and mepivacaine (107 min; 95% CI 92-121), which were not different.",['12 horses'],"['mepivacaine', 'lidocaine', 'prilocaine', 'Prilocaine', 'local anaesthetic (LA', 'lidocaine, bupivacaine, mepivacaine and prilocaine', 'bupivacaine']","['mechanical nociceptive threshold (MNT', 'Onset and duration of complete desensitisation']","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}]","[{'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.029443,"Duration for lidocaine (mean 25 min; 95% confidence interval [CI] 9-42) was shorter than bupivacaine (53 min; 95% CI 39-65), which was shorter than both prilocaine (102 min; 95% CI 81-123) and mepivacaine (107 min; 95% CI 92-121), which were not different.","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Harcourt', 'Affiliation': 'Equine Department, College of Veterinary Medicine, Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Smith', 'Affiliation': 'Equine Department, College of Veterinary Medicine, Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hosgood', 'Affiliation': 'Small Animal Surgery Department, College of Veterinary Medicine, Murdoch University, Perth, Western Australia, Australia.'}]",Australian veterinary journal,['10.1111/avj.13122']
1657,34567480,Effects of Natural Convalescent Factors Combined with Motor Intelligence Management on Patients' Blood Pressure.,"To explore the application of natural convalescent factors combined with exercise intelligence management in blood pressure control of patients with hypertension, 102 patients with hypertension who were admitted from January 2017 to August 2019 were selected as the research subjects. According to the odd-even number method, they were divided into two groups with 51 cases in each group. The control group was treated with natural convalescent factor therapy alone, and the observation group was treated with natural convalescent factor combined with motor intelligence management. The application effects of the two groups were compared. Before sports intelligence management, the levels of systolic blood pressure (SBP) in control group and observation group were (145.45 ± 8.44) mmHg (1 mmHg = 0.133 kPa) and (146.55 ± 8.37) mmHg, respectively; the diastolic blood pressure (DBP) levels of the control group and the observation group were (98.47 ± 3.48) mmHg and (98.94 ± 3.48) mmHg, respectively, with no statistical significance ( P  > 0.05). After the exercise intelligence management, the SBP levels of the control group and the observation group were (132.76 ± 4.48) mmHg and (130.06 ± 2.48) mmHg, respectively. The DBP levels of the control group and the observation group were (85.48 ± 5.38) mmHg and (83.47 ± 3.35) mmHg, respectively. The difference was statistically significant ( P  < 0.05). The scores of each index of quality of life in the observation group were higher than those in the control group, and the differences of physical function and psychological/mental scores were significant. The scores of physical function in the two groups before administration were (48.36 ± 1.69) and (48.74 ± 1.62), and the differences were not statistically significant ( P  > 0.05). After management, the physiological function scores of the two groups were (40.32 ± 1.33) and (32.15 ± 1.54) and the difference was statistically significant ( P  < 0.05). There were no significant differences in the psychological (30.75 ± 1.26)/mental scores (30.26 ± 1.48) between the two groups before management ( P  > 0.05), but there were significant differences in the psychological (25.30 ± 1.02)/mental scores (18.76 ± 1.36) between the two groups after management ( P  < 0.05). The combination of natural convalescent factors and intelligent exercise management can effectively control the blood pressure level and improve the quality of life of patients with hypertension, and the clinical application effect is good.",2021,"The scores of each index of quality of life in the observation group were higher than those in the control group, and the differences of physical function and psychological/mental scores were significant.","[""Patients' Blood Pressure"", 'patients with hypertension', 'patients with hypertension, 102 patients with hypertension who were admitted from January 2017 to August 2019 were selected as the research subjects']","['natural convalescent factors combined with exercise intelligence management', 'natural convalescent factor therapy alone, and the observation group was treated with natural convalescent factor combined with motor intelligence management', 'natural convalescent factors and intelligent exercise management', 'Natural Convalescent Factors Combined with Motor Intelligence Management']","['scores of each index of quality of life', 'diastolic blood pressure (DBP) levels', 'blood pressure level', 'DBP levels', 'physical function and psychological/mental scores', 'SBP levels', 'physiological function scores', 'blood pressure control', 'levels of systolic blood pressure (SBP', 'psychological', 'scores of physical function', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",102.0,0.00412732,"The scores of each index of quality of life in the observation group were higher than those in the control group, and the differences of physical function and psychological/mental scores were significant.","[{'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Lintong Rehabilitation and Recuperation Center, Lintong 710600, China.'}, {'ForeName': 'Zhuoming', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Lintong Rehabilitation and Recuperation Center, Lintong 710600, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Lintong Rehabilitation and Recuperation Center, Lintong 710600, China.'}]",Journal of healthcare engineering,['10.1155/2021/2917226']
1658,34533215,Enzyme replacement therapy with galsulfase for mucopolysaccharidosis type VI.,"BACKGROUND


Mucopolysaccharidosis type VI (MPS VI) or Maroteaux-Lamy syndrome is a rare genetic disorder caused by the deficiency of arylsulphatase B. The resultant accumulation of dermatan sulphate causes lysosomal damage. The clinical symptoms are related to skeletal dysplasia (i.e. short stature and degenerative joint disease). Other manifestations include cardiac disease, impaired pulmonary function, ophthalmological complications, hepatosplenomegaly, sinusitis, otitis, hearing loss and sleep apnea. Intellectual impairment is generally absent. Clinical manifestation is typically by two or three years of age; however, slowly progressive cases may not present until adulthood. Enzyme replacement therapy (ERT) with galsulfase is considered a new approach for treating MPS VI.
OBJECTIVES


To evaluate the effectiveness and safety of treating MPS VI by ERT with galsulfase compared to other interventions, placebo or no intervention.
SEARCH METHODS


Eletronic searches were performed on the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register. Date of the latest search:  09 June 2021. Further searches of the following databases were also performed: CENTRAL, MEDLINE, LILACS, the Journal of Inherited Metabolic Disease, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov. Date of the latest search: 20 August 2021.
SELECTION CRITERIA


Randomized and quasi-randomized controlled clinical studies of ERT with galsulfase compared to other interventions or placebo.
DATA COLLECTION AND ANALYSIS


Two authors independently screened the studies, assessed the risk of bias, extracted data and assessed the certainty of the the evidence using the GRADE criteria.
MAIN RESULTS


One study was included involving 39 participants who received either ERT with galsulfase (recombinant human arylsulphatase B) or placebo. This small study was considered overall to have an unclear risk of bias in relation to the design and implementation of the study, since the authors did not report how both the allocation generation and concealment were performed. Given the very low certainty of the evidence, we are uncertain whether at 24 weeks there was a difference between groups in relation to the 12-minute walk test, mean difference (MD) of 92.00 meters (95% confidence interval (CI) 11.00 to 172.00), or the three-minute stair climb, MD 5.70 (95% CI -0.10 to 11.50). In relation to respiratory tests, we are uncertain whether galsulfase makes any difference as compared to placebo in forced vital capacity in litres (FVC (L) (absolute change in baseline), given the very low certainty of the evidence. Cardiac function was not reported in the included study. We found that galsulfase, as compared to placebo, may decrease urinary glycosaminoglycan levels at 24 weeks, MD -227.00 (95% CI -264.00 to -190.00) (low-certainty evidence). We are uncertain whether there are differences between the galsulfase and placebo groups in relation to adverse events (very low-certainty evidence). In general, the dose of galsulfase was well tolerated and there were no differences between groups. These events include drug-related adverse events, serious and severe adverse events, those during infusion, drug-related adverse events during infusion, and deaths. More infusion-related reactions were observed in the galsulfase group and were managed with interruption or slowing of infusion rate or administration of antihistamines or corticosteroids drugs. No deaths occurred during the study.   AUTHORS' CONCLUSIONS: The results of this review are based only on one small study (a 24-week randomised phase of the study and prior to the open-label extension). We are uncertain whether galsulfase is more effective than placebo, for treating people with MPS VI, in relation to the 12-minute walk test or the three-minute stair climb, as the certainty of the evidence has been assessed as very low. We found that galsulfase may reduce urinary glycosaminoglycans levels. We are also uncertain whether there are any differences between treatment groups in relation to cardiac or pulmonary functions, liver or spleen volume, overnight apnea-hypopnea, height and weight, quality of life and adverse effects. Further studies are needed to obtain more information on the long-term effectiveness and safety of ERT with galsulfase.",2021,"We are also uncertain whether there are any differences between treatment groups in relation to cardiac or pulmonary functions, liver or spleen volume, overnight apnea-hypopnea, height and weight, quality of life and adverse effects.","['One study was included involving 39 participants who received either ERT with galsulfase (recombinant human arylsulphatase B) or', ""Eletronic searches were performed on the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register""]","['placebo', 'Enzyme replacement therapy (ERT']","['Intellectual impairment', 'cardiac disease, impaired pulmonary function, ophthalmological complications, hepatosplenomegaly, sinusitis, otitis, hearing loss and sleep apnea', 'deaths', 'urinary glycosaminoglycans levels', 'urinary glycosaminoglycan levels', 'cardiac or pulmonary functions, liver or spleen volume, overnight apnea-hypopnea, height and weight, quality of life and adverse effects', 'Cardiac function', 'forced vital capacity in litres (FVC (L']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C1615657', 'cui_str': 'galsulfase'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0003940', 'cui_str': 'Arylsulfatase'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0019247', 'cui_str': 'Hereditary disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025521', 'cui_str': 'Inborn error of metabolism'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}]","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0858943', 'cui_str': 'Pulmonary function impairment'}, {'cui': 'C2013096', 'cui_str': 'OPHTHALMOLOGICALS'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019214', 'cui_str': 'Hepatosplenomegaly'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0029877', 'cui_str': 'Otitis'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017973', 'cui_str': 'Mucopolysaccharide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",39.0,0.194297,"We are also uncertain whether there are any differences between treatment groups in relation to cardiac or pulmonary functions, liver or spleen volume, overnight apnea-hypopnea, height and weight, quality of life and adverse effects.","[{'ForeName': 'Marcela Junqueira', 'Initials': 'MJ', 'LastName': 'Brunelli', 'Affiliation': 'Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Álvaro N', 'Initials': 'ÁN', 'LastName': 'Atallah', 'Affiliation': 'Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, São Paulo, Brazil.'}, {'ForeName': 'Edina Mk', 'Initials': 'EM', 'LastName': 'da Silva', 'Affiliation': 'Emergency Medicine and Evidence Based Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009806.pub3']
1659,34535961,DNA methylation-based biomarkers of aging were slowed down in a two-year diet and physical activity intervention trial: the DAMA study.,"Several biomarkers of healthy aging have been proposed in recent years, including the epigenetic clocks, based on DNA methylation (DNAm) measures, which are getting increasingly accurate in predicting the individual biological age. The recently developed ""next-generation clock"" DNAmGrimAge outperforms ""first-generation clocks"" in predicting longevity and the onset of many age-related pathological conditions and diseases. Additionally, the total number of stochastic epigenetic mutations (SEMs), also known as the epigenetic mutation load (EML), has been proposed as a complementary DNAm-based biomarker of healthy aging. A fundamental biological property of epigenetic, and in particular DNAm modifications, is the potential reversibility of the effect, raising questions about the possible slowdown of epigenetic aging by modifying one's lifestyle. Here, we investigated whether improved dietary habits and increased physical activity have favorable effects on aging biomarkers in healthy postmenopausal women. The study sample consists of 219 women from the ""Diet, Physical Activity, and Mammography"" (DAMA) study: a 24-month randomized factorial intervention trial with DNAm measured twice, at baseline and the end of the trial. Women who participated in the dietary intervention had a significant slowing of the DNAmGrimAge clock, whereas increasing physical activity led to a significant reduction of SEMs in crucial cancer-related pathways. Our study provides strong evidence of a causal association between lifestyle modification and slowing down of DNAm aging biomarkers. This randomized trial elucidates the causal relationship between lifestyle and healthy aging-related epigenetic mechanisms.",2021,"Women who participated in the dietary intervention had a significant slowing of the DNAmGrimAge clock, whereas increasing physical activity led to a significant reduction of SEMs in crucial cancer-related pathways.","['healthy postmenopausal women', '219 women from the ""Diet, Physical Activity, and Mammography"" (DAMA) study', 'Women who participated in the']",['dietary intervention'],"['DNAmGrimAge clock', 'total number of stochastic epigenetic mutations (SEMs', 'physical activity']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",219.0,0.0346525,"Women who participated in the dietary intervention had a significant slowing of the DNAmGrimAge clock, whereas increasing physical activity led to a significant reduction of SEMs in crucial cancer-related pathways.","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fiorito', 'Affiliation': 'Laboratory of Biostatistics, Department of Biomedical Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Caini', 'Affiliation': 'Institute for Cancer Research, Prevention and Clinical Network - ISPRO, Florence, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Palli', 'Affiliation': 'Institute for Cancer Research, Prevention and Clinical Network - ISPRO, Florence, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Bendinelli', 'Affiliation': 'Institute for Cancer Research, Prevention and Clinical Network - ISPRO, Florence, Italy.'}, {'ForeName': 'Calogero', 'Initials': 'C', 'LastName': 'Saieva', 'Affiliation': 'Institute for Cancer Research, Prevention and Clinical Network - ISPRO, Florence, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Ermini', 'Affiliation': 'Institute for Cancer Research, Prevention and Clinical Network - ISPRO, Florence, Italy.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Valentini', 'Affiliation': 'Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Melania', 'Initials': 'M', 'LastName': 'Assedi', 'Affiliation': 'Institute for Cancer Research, Prevention and Clinical Network - ISPRO, Florence, Italy.'}, {'ForeName': 'Piera', 'Initials': 'P', 'LastName': 'Rizzolo', 'Affiliation': 'Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ambrogetti', 'Affiliation': 'Institute for Cancer Research, Prevention and Clinical Network - ISPRO, Florence, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ottini', 'Affiliation': 'Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Masala', 'Affiliation': 'Institute for Cancer Research, Prevention and Clinical Network - ISPRO, Florence, Italy.'}]",Aging cell,['10.1111/acel.13439']
1660,34535893,A matching procedure for sequential experiments that iteratively learns which covariates improve power.,"We propose a dynamic allocation procedure that increases power and efficiency when measuring an average treatment effect in sequential randomized trials exploiting some subjects' previous assessed responses. Subjects arrive sequentially and are either randomized or paired to a previously randomized subject and administered the alternate treatment. The pairing is made via a dynamic matching criterion that iteratively learns which specific covariates are important to the response. We develop estimators for the average treatment effect as well as an exact test. We illustrate our method's increase in efficiency and power over other allocation procedures in both simulated scenarios and a clinical trial dataset. An R package ""SeqExpMatch"" for use by practitioners is available on CRAN.",2021,We illustrate our method's increase in efficiency and power over other allocation procedures in both simulated scenarios and a clinical trial dataset.,[],[],[],[],[],[],,0.0263543,We illustrate our method's increase in efficiency and power over other allocation procedures in both simulated scenarios and a clinical trial dataset.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kapelner', 'Affiliation': 'Department of Mathematics, Queens College, CUNY, Queens, New York, USA.'}, {'ForeName': 'Abba', 'Initials': 'A', 'LastName': 'Krieger', 'Affiliation': 'Department of Statistics, The Wharton School at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]",Biometrics,['10.1111/biom.13561']
1661,34536801,Hydrothermal aging affects the three-dimensional fit and fatigue lifetime of zirconia abutments.,"OBJECTIVE


Evaluate the effect of aging using two different methods on the three-dimensional fit of zirconia abutments at the implant-abutment connection and estimate the probability of survival of anterior crowns supported by straight and 17-degree angled abutments.
MATERIALS AND METHODS


Two different zirconia abutment designs, straight and 17-degree angled abutments (n = 63/group), were evaluated in the current study. The abutments were randomly allocated into three experimental groups according to laboratory aging condition (134°C, 2.2 bar, 20 h): (i) control, (ii) autoclave aging, and (iii) hydrothermal reactor aging. Crystalline content was determined by X-Ray diffraction (XRD) and Raman spectroscopy, and microstructure was analyzed using field-emission gun scanning electron microscope (FEG-SEM). Implant-abutment volume misfit was determined in the straight abutments by micro-computed tomography using the silicone replica technique. For fatigue testing, abutments were torqued to the implants and connected to standardized maxillary incisor zirconia crowns. The assemblies were subjected to step-stress accelerated life testing (SSALT) in water until fracture or suspension. The use level probability Weibull curves and probability of survival for a mission of 50,000 cycles at 50, 100, 150 and 200 N were calculated and plotted. Fractured samples were analyzed using a stereomicroscope and scanning electron microscope.
RESULTS


The crystalline spectra depicted a zirconia system primarily composed of the tetragonal phase. Laboratory aging yielded a 20%- and 37%-increase in the monoclinic content for abutments aged in autoclave and hydrothermal reactor relative to control, respectively. A fully crystalline matrix with a regular grain size was observed in the FEG-SEM for control abutments, with a considerable presence of intergranular defects. While autoclave aging triggered no significant alteration to the microstructure, defect population was reduced after hydrothermal reactor aging. Control abutments presented a significantly higher volume misfit (2.128 ± 0.54 mm 3 ) relative to aged abutments using autoclave (1.244 ± 0.48 mm 3 ) or hydrothermal reactor (1.441 ± 0.41 mm 3 ). The beta (β) values indicated that failures were predominantly controlled by material strength rather than fatigue damage accumulation for all groups, except for straight control abutments. Irrespective of aging, the probability of survival of straight and angled zirconia abutments was up to 95% (95-100%) at 50 and 100 N. A 50N-increase in the load resulted in wider range of survival estimate, with straight autoclave abutments percentage significantly lower probability of survival (77%) than angled hydrothermal reactor abutments (99%). At 200N, angled hydrothermal reactor (97%) or autoclave (82%) aged abutments demonstrated the highest probability of survival, angled control (71%) and straight hydrothermal reactor (69%) abutments intermediate values, and straight autoclave (23%) and control (7%) abutments the lowest estimate. The failure mode predominantly involved abutment and/or abutment screw fracture for both straight and angled abutments.
CONCLUSIONS


Hydrothermal aging significantly influenced volume misfit, as well as the probability of survival of zirconia abutments at higher loads for both angled and straight abutments.",2021,"Irrespective of aging, the probability of survival of straight and angled zirconia abutments was up to 95% (95-100%) at 50 and 100 N. A 50N-increase in the load resulted in wider range of survival estimate, with straight autoclave abutments percentage significantly lower probability of survival (77%) than angled hydrothermal reactor abutments (99%).","['Two different zirconia abutment designs, straight and 17-degree angled abutments (n\xa0=\xa063/group']","['laboratory aging condition (134°C, 2.2\xa0bar, 20\xa0h): (i) control, (ii) autoclave aging, and (iii) hydrothermal reactor aging']","['highest probability of survival', 'straight hydrothermal reactor', 'probability of survival of zirconia abutments', 'Crystalline content', 'angled hydrothermal reactor', 'probability of survival of straight and angled zirconia abutments', 'wider range of survival estimate', 'probability of survival']","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0179177', 'cui_str': 'Autoclave'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",,0.0584243,"Irrespective of aging, the probability of survival of straight and angled zirconia abutments was up to 95% (95-100%) at 50 and 100 N. A 50N-increase in the load resulted in wider range of survival estimate, with straight autoclave abutments percentage significantly lower probability of survival (77%) than angled hydrothermal reactor abutments (99%).","[{'ForeName': 'Edmara T P', 'Initials': 'ETP', 'LastName': 'Bergamo', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry - University of Sao Paulo, 9-75 Octavio Pinheiro Brizolla, 17012-901, Bauru, SP, Brazil. Electronic address: edmaratatiely@gmail.com.'}, {'ForeName': 'Tiago M B', 'Initials': 'TMB', 'LastName': 'Campos', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry - University of Sao Paulo, 9-75 Octavio Pinheiro Brizolla, 17012-901, Bauru, SP, Brazil.'}, {'ForeName': 'Adolfo C O', 'Initials': 'ACO', 'LastName': 'Lopes', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry - University of Sao Paulo, 9-75 Octavio Pinheiro Brizolla, 17012-901, Bauru, SP, Brazil.'}, {'ForeName': 'Karina B', 'Initials': 'KB', 'LastName': 'Cardoso', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry - University of Sao Paulo, 9-75 Octavio Pinheiro Brizolla, 17012-901, Bauru, SP, Brazil.'}, {'ForeName': 'Marcus V R', 'Initials': 'MVR', 'LastName': 'Gouvea', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry - University of Sao Paulo, 9-75 Octavio Pinheiro Brizolla, 17012-901, Bauru, SP, Brazil.'}, {'ForeName': 'Everardo N S', 'Initials': 'ENS', 'LastName': 'de Araújo-Júnior', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry - University of Sao Paulo, 9-75 Octavio Pinheiro Brizolla, 17012-901, Bauru, SP, Brazil.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Witek', 'Affiliation': 'Department of Biomaterials, New York University College of Dentistry, 433 1st Avenue, New York, NY, USA; Department of Biomedical Engineering, New York University Tandon School of Engineering, 6 MetroTech Center, Brooklyn, NY, USA.'}, {'ForeName': 'Petra C', 'Initials': 'PC', 'LastName': 'Gierthmühlen', 'Affiliation': 'Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University, Moorenstraße 5, 40225 Düsseldorf, Germany.'}, {'ForeName': 'Paulo G', 'Initials': 'PG', 'LastName': 'Coelho', 'Affiliation': 'Department of Biomaterials, New York University College of Dentistry, 433 1st Avenue, New York, NY, USA; Hansjörg Wyss Department of Plastic Surgery, NYU Langone Medical Center, 222 East 41st Street New York, NY, USA; Department of Mechanical Engineering, New York University Tandon School of Engineering, 6 MetroTech Center, Brooklyn, NY, USA.'}, {'ForeName': 'Ernesto B', 'Initials': 'EB', 'LastName': 'Benalcázar Jalkh', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry - University of Sao Paulo, 9-75 Octavio Pinheiro Brizolla, 17012-901, Bauru, SP, Brazil; Department of Biomaterials, New York University College of Dentistry, 433 1st Avenue, New York, NY, USA.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Zahoui', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry - University of Sao Paulo, 9-75 Octavio Pinheiro Brizolla, 17012-901, Bauru, SP, Brazil.'}, {'ForeName': 'Laura F', 'Initials': 'LF', 'LastName': 'de Carvalho', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry - University of Sao Paulo, 9-75 Octavio Pinheiro Brizolla, 17012-901, Bauru, SP, Brazil.'}, {'ForeName': 'Estevam A', 'Initials': 'EA', 'LastName': 'Bonfante', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry - University of Sao Paulo, 9-75 Octavio Pinheiro Brizolla, 17012-901, Bauru, SP, Brazil.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2021.104832']
1662,34536714,The cognitive anxiety sensitivity treatment (CAST) in anxiety prevention - Focus on separation anxiety and interoception.,"Given the high prevalence and considerable clinical and societal burden of anxiety disorders, preventive measures are urgently warranted to reduce their incidence and overall healthcare impact. Anxiety sensitivity (AS) - a key element in learning theories of anxiety disorders in the context of interoceptive conditioning - constitutes a malleable risk factor of particularly panic disorder and separation anxiety, which share developmental, nosological, epidemiological and pathomechanistic characteristics. The computer-assisted 'Cognitive Anxiety Sensitivity Treatment' (CAST) targeting interoceptive anxiety symptoms (cf. Schmidt et al., 2014) was translated, intensified and culturally adapted to German and evaluated in a sample of 105 healthy adult volunteers with elevated AS (mean ASI-3: 29.5) applying a randomized design. Success of the intervention was measured as a function of AS and separation anxiety (ASA-27) ∼6 weeks (T1) and ∼6 months (T2) after the intervention. As compared to waitlist, CAST resulted in a significant reduction of AS at both T1 and T2. Separation anxiety was not directly reduced by the intervention, but decreased mediated by a decline in AS. A composite interoceptive score capturing changes in sensitivity to respiratory symptoms during the baseline therapist-accompanied CAST session was shown to be predictive of overall response at T1. In sum, CAST-German Version was successfully established as an effective intervention reducing AS, while at the same time indirectly decreasing separation anxiety. A composite interoceptive score predicting treatment response might aid in further delineating risk markers informing targeted preventive interventions for anxiety disorders.",2021,"As compared to waitlist, CAST resulted in a significant reduction of AS at both T1 and T2.",['105 healthy adult volunteers with elevated AS (mean ASI-3: 29.5'],"['cognitive anxiety sensitivity treatment (CAST', ""computer-assisted 'Cognitive Anxiety Sensitivity Treatment' (CAST""]","['function of AS and separation anxiety (ASA-27) ∼6 weeks (T1) and ∼6 months (T2', 'Separation anxiety', 'separation anxiety']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0003477', 'cui_str': 'Separation anxiety'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",105.0,0.0232603,"As compared to waitlist, CAST resulted in a significant reduction of AS at both T1 and T2.","[{'ForeName': 'Miriam A', 'Initials': 'MA', 'LastName': 'Schiele', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Vietz', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Gajewska', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Unterecker', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Gottschalk', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Deckert', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Neufang', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany,; Comparative Psychology, Institute of Experimental Psychology, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, Department of Psychology, Tallahassee, FL, USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Domschke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Center for Basics in Neuromodulation, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: katharina.domschke@uniklinik-freiburg.de.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2021.08.265']
1663,34536716,Impacts of the respecting the circle of life teen pregnancy prevention program on risk and protective factors for early substance use among native American youth.,"BACKGROUND


Early substance use disproportionately impacts Native American (Native) youth and increases their risk for future abuse and dependence. The literature urges for interventions to move beyond focusing on single risk behaviors (e.g. substance use) and instead have capacity to improve health risk behaviors co-occuring during adolescence, particularly among Native populations for whom few evidence-based interventions (EBI) exist. We evaluated the effectiveness of the Respecting the Circle of Life program (RCL) on risk and protective factors for early substance use. RCL is a culturally tailored EBI shown to improve sexual health outcomes among Native youth.
METHODS


We conducted secondary analyses of data collected through a community-based randomized controlled trial of RCL evaluated among Native youth (ages 11-19) residing on a rural reservation between 2015-2020 (N = 534, 47.4 % male). We used linear regression, controlling for baseline age and sex, to test between study group differences in outcomes at 3-, 9-, and 12-month post-intervention. Models were stratified by sex and age (11-12, 13-14, and 15+ years of age) to examine differences within these subgroups.
RESULTS


Youth receiving RCL reported lower intention to use substances through 12-months follow-up (p = 0.006). Statistically significant improvements were also observed across peer, parent, and sexual partner risk and protective factors to delay substance use initiation, with notable differences among boys and participants ages 13-14.
CONCLUSIONS


RCL is a primary prevention, skills-based program effective in preventing risks for substance use. This evaluation underscores the value in developing programs that influence concurrent adolescent risk behaviors, especially for Native communities who endure multiple health disparities.",2021,"Statistically significant improvements were also observed across peer, parent, and sexual partner risk and protective factors to delay substance use initiation, with notable differences among boys and participants ages 13-14.
","['Native youth (ages 11-19) residing on a rural reservation between 2015-2020 (N = 534, 47.4 % male', 'native American youth']","['Circle of Life program (RCL', 'RCL']","['sexual health outcomes', 'sexual partner risk and protective factors to delay substance use initiation']","[{'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}]","[{'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0679133', 'cui_str': 'Respect'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",,0.0230255,"Statistically significant improvements were also observed across peer, parent, and sexual partner risk and protective factors to delay substance use initiation, with notable differences among boys and participants ages 13-14.
","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Tingey', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Center for American Indian Health, 415 N. Washington St., Baltimore, MD, 21231, USA. Electronic address: ltingey1@jhu.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Chambers', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Center for American Indian Health, 415 N. Washington St., Baltimore, MD, 21231, USA.'}, {'ForeName': 'Hima', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Center for American Indian Health, 415 N. Washington St., Baltimore, MD, 21231, USA.'}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Littlepage', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Center for American Indian Health, 415 N. Washington St., Baltimore, MD, 21231, USA.'}, {'ForeName': 'Shauntel', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Center for American Indian Health, 308 Kuper St., Whiteriver, AZ, 85941, USA.'}, {'ForeName': 'Angelita', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Center for American Indian Health, 308 Kuper St., Whiteriver, AZ, 85941, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pinal', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Center for American Indian Health, 308 Kuper St., Whiteriver, AZ, 85941, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Slimp', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Center for American Indian Health, 308 Kuper St., Whiteriver, AZ, 85941, USA.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Rosenstock', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Center for American Indian Health, 415 N. Washington St., Baltimore, MD, 21231, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109024']
1664,34537184,Left atrial appendage occlusion vs novel oral anticoagulation for stroke prevention in atrial fibrillation: rationale and design of the multicenter randomized occlusion-AF trial.,"BACKGROUND


The prevalence of atrial fibrillation (AF) is increasing globally, which is a major clinical and public health concern due to the 5-fold increased risk of stroke. Oral anticoagulation with novel oral anticoagulants (NOACs) is the current primary option for stroke prevention in patients with AF, although it increases the risk of major bleeding. Patients with prior ischemic cerebrovascular events are at particularly high risk of both recurrent ischemic events and major bleeding. Left atrial appendage occlusion (LAAO) provides an alternative option for stroke prevention in high-risk patients, however, with currently limited evidence. Thus, randomized trials comparing LAAO to NOACs are needed.
OBJECTIVE


The Occlusion-AF trial is designed to assess whether LAAO is non-inferior to NOAC therapy for reduction of the combined endpoint of stroke, systemic embolism, major bleeding (Bleeding Academic Research Consortium ≥ 3) and all-cause mortality in patients with AF and a recent ischemic stroke or transient ischemic attack (TIA).
METHODS AND ANALYSIS


Investigator-initiated multicenter, multinational, randomized open-label non-inferiority trial with blinded outcome evaluation (PROBE design). Patients with documented AF, and an ischemic stroke or TIA within 6 months will be eligible for enrollment. Major exclusion criteria are modified Rankin Scale > 3 at enrollment, glomerular filtration rate < 15 ml/min, and life-expectancy less than 2 years. A total of 750 patients will be randomized 1:1 to receive either a NOAC or LAAO using the Amplatzer Amulet (Abbott, MN, USA) or Watchman FLX (Boston Scientific, MN, USA) with subsequent life-long aspirin 75 mg daily. Follow-up will be based on in-office and telephone follow-up in combination with long-term follow-up (10 years) through national hospital discharge registries in the individual Nordic countries. The primary outcome will be a composite endpoint of stroke, systemic embolism, major bleeding (BARC ≥ 3) and all-cause mortality at 2-year follow-up.
CONCLUSIONS


The Occlusion-AF trial is designed to compare LAAO to NOAC therapy for secondary stroke prevention in AF patients with a high risk of recurrent thromboembolic events, i.e. with previous ischemic stroke or TIA, and otherwise eligible for anticoagulation. The results are expected to contribute significantly to the understanding of the effects of LAAO compared to the standard contemporary pharmacological treatment in these patients.",2021,The results are expected to contribute significantly to the understanding of the effects of LAAO compared to the standard contemporary pharmacological treatment in these patients.,"['AF patients with a high risk of recurrent thromboembolic events', 'patients with AF and a recent ischemic stroke or transient ischemic attack (TIA', 'patients with AF', 'Atrial Fibrillation', '750 patients', 'Patients with documented AF, and an ischemic stroke or TIA within 6 months will be eligible for enrollment', 'Patients with prior ischemic cerebrovascular events', 'high-risk patients']","['NOAC or LAAO using the Amplatzer Amulet (Abbott, MN, USA) or Watchman FLX (Boston Scientific, MN, USA) with subsequent life-long aspirin', 'LAAO', 'LAAO to NOAC therapy', 'Left Atrial Appendage Occlusion versus Novel Oral Anticoagulation', 'Oral anticoagulation with novel oral anticoagulants (NOACs', 'Left atrial appendage occlusion (LAAO']","['composite endpoint of stroke, systemic embolism, major bleeding (BARC ≥ 3) and all-cause mortality at 2-year follow-up', 'recurrent ischemic events and major bleeding']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0642228', 'cui_str': 'N(4)-oleylcytosine arabinoside'}, {'cui': 'C3275093', 'cui_str': 'Left atrial appendage occlusion'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0335390', 'cui_str': 'Watchman'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",750.0,0.0846681,The results are expected to contribute significantly to the understanding of the effects of LAAO compared to the standard contemporary pharmacological treatment in these patients.,"[{'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Korsholm', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark; Department of Cardiology, Regional Hospital, West Jutland, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Damgaard', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jan Brink', 'Initials': 'JB', 'LastName': 'Valentin', 'Affiliation': 'Danish Center for Clinical Health Services Research, Department of Clinical Medicine, Aalborg University and Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Erik Jerome Stene', 'Initials': 'EJS', 'LastName': 'Packer', 'Affiliation': 'Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Odenstedt', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Sinisalo', 'Affiliation': 'Heart and Lung Center, Helsinki University Central Hospital, and Helsinki University Helsinki, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Putaala', 'Affiliation': 'Department of Neurology, Helsinki University Hospital and University of Helsinki, Finland.'}, {'ForeName': 'Halvor', 'Initials': 'H', 'LastName': 'Næss', 'Affiliation': 'Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Mohammad Ahmad', 'Initials': 'MA', 'LastName': 'Al-Jazi', 'Affiliation': 'Department of Neurology, Regional Hospital, West Jutland, Denmark.'}, {'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Karlsson', 'Affiliation': 'Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Pontoppidan', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Modrau', 'Affiliation': 'Department of Neurology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Hjort', 'Affiliation': 'Clinical Trial Unit, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Kristina Laut', 'Initials': 'KL', 'LastName': 'Matzen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Søren Paaske', 'Initials': 'SP', 'LastName': 'Johnsen', 'Affiliation': 'Danish Center for Clinical Health Services Research, Department of Clinical Medicine, Aalborg University and Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens Erik', 'Initials': 'JE', 'LastName': 'Nielsen-Kudsk', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark. Electronic address: je.nielsen.kudsk@gmail.com.'}]",American heart journal,['10.1016/j.ahj.2021.08.020']
1665,34534232,The minimum effective concentration (MEC90) of ropivacaine for ultrasound-guided caudal block in anorectal surgery. A dose finding study.,"BACKGROUND


Caudal epidural block (CEB) provides reliable anesthesia for adults undergoing anorectal surgery. Despite the widely utilization, the minimum effective concentration for 90% patients (MEC90) of ropivacaine for CEB remains unknown.
OBJECTIVE


To estimate MEC of ropivacaine for CEB in anorectal surgery.
DESIGN


A prospective dose-finding study using biased coin design up-and-down sequential method.
SETTING


Operating room and postoperative recovery area of Chengdu Shangjin Nanfu Hospital, from October 2019 to January 2020.
PATIENTS


50 males and 51 females scheduled for anorectal surgery.
INTERVENTIONS


We conducted two independent biased coin design up-and down trials by genders. The concentration of ropivacaine administered to the first patient of male and female were 0.25% with fixed volume of 14ml for male and 12ml for female patients based on our previous study. In case of failure, the concentration was increased by 0.05% in the next subject. Otherwise, the next subject was randomized to a concentration 0.05% less with a probability of 0.11, or the same concentration with a probability of 0.89. Success was defined as complete sensory blockade of perineal area 15 min after the block evidenced by the presence of a lax anal sphincter and pain-free surgery.
MAIN OUTCOME MEASURES


The MEC of ropivacaine to achieve a successful CEB in 90%(MEC90) of the patients.
RESULTS


The MEC90 of ropivacaine for CEB were estimated to be 0.35% (95% CI 0.29 to 0.4%) for male and 0.353% (95%CI 0.22 to 0.4%) for female. By extrapolation to MEC in 99% of subjects (MEC99) and pooled adjacent violators algorithm (PAVA) adjusted responses, it would be optimal to choose 0.4% ropivacaine with a volume of 14ml for male and 12ml for female.
CONCLUSIONS


A concentration of 0.35% ropivacaine with a volume of 14ml provided a successful CEB in 90% of the male patients, while 0.353% ropivacaine with a volume of 12ml provided a successful CEB in 90% of the female patients. A concentration of 0.4% and a volume of 14ml for male and 12 ml for female would be successful in 99% of the patients.
TRIAL REGISTRATION


Chictr.org.cn identifier: No. ChiCTR 1900024315.",2021,The MEC90 of ropivacaine for CEB were estimated to be 0.35% (95% CI 0.29 to 0.4%) for male and 0.353% (95%CI 0.22 to 0.4%) for female.,"['Chictr.org.cn identifier', 'Operating room and postoperative recovery area of Chengdu Shangjin Nanfu Hospital, from October 2019 to January 2020', 'anorectal surgery', '50 males and 51 females scheduled for anorectal surgery', 'adults undergoing anorectal surgery']","['ropivacaine', 'Caudal epidural block (CEB']","['successful CEB', 'lax anal sphincter and pain-free surgery']","[{'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0426765', 'cui_str': 'Anal sphincter tone absent'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",,0.0730149,The MEC90 of ropivacaine for CEB were estimated to be 0.35% (95% CI 0.29 to 0.4%) for male and 0.353% (95%CI 0.22 to 0.4%) for female.,"[{'ForeName': 'Xuehan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, and Laboratory of Anesthesia and Intensive Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, and Laboratory of Anesthesia and Intensive Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, and Laboratory of Anesthesia and Intensive Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Huifei', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology, and Laboratory of Anesthesia and Intensive Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Mingan', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Division of Biostatistics & Epidemiology, School of Public Health, San Diego State University, San Diego, CA, United States of America.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Benign Coloproctological Diseases Center, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Rurong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, and Laboratory of Anesthesia and Intensive Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}]",PloS one,['10.1371/journal.pone.0257283']
1666,34546614,The wound healing effect of local leukocyte platelet-rich plasma after total hip arthroplasty: A randomized controlled trial.,"Rapid wound closure is important after arthroplasty procedures to prevent postoperative complications. Platelets are rich in growth factors and leukocytes contribute to innate immunity. We hypothesized that topical leukocyte platelet-rich plasma (L-PRP) derived from the blood of patients would be beneficial to wound healing. In this randomized controlled trial, patients subjected to elective total hip arthroplasty (THA) were assigned by concealed allocation either L-PRP application onto the sutured fascia or no application (control) after the THA intervention. In addition, all patients received 1.5 g protein/kg, 5 g L-arginine, 500 mg vitamin C and 44 mg zinc daily over the 4-week postoperative period to obtain optimal nutrition. The primary endpoint was complete healing of the skin incision. The secondary endpoints were blood transfusions, length of hospital stay, pain and wound infections. Sixteen patients in the L-PRP group and 17 patients in the control group completed the trial. L-PRP treatment accelerated complete wound healing after 3 weeks (seven in the L-PRP group vs. zero in the control group, p = 0.003) and after 4 weeks (12 in the L-PRP group vs. six in the control group, p = 0.037). No postoperative superficial wound infections occurred within 4 weeks, and there were no significant differences in the other secondary outcomes. L-PRP generated in 10 sex-matched healthy volunteers revealed increased concentrations of platelets (5.8-fold) and leukocytes (2.3-fold) compared with those in whole blood. Furthermore, the concentration of keratinocyte mitogen epidermal growth factor in L-PRP (380 ± 130 pg/ml, mean ± SD) was higher (p < 0.001) than that in serum (130 ± 26 pg/ml). In conclusion, a single intraoperative local application of L-PRP promoted wound healing after THA, possibly mediated by EGF receptor agonists.",2021,"L-PRP treatment accelerated complete wound healing after 3 weeks (seven in the L-PRP group vs. zero in the control group, p = 0.003) and after 4 weeks (12 in the L-PRP group vs. six in the control group, p = 0.037).","['Sixteen patients in the L-PRP group and 17 patients in the control group completed the trial', 'patients subjected to elective total hip arthroplasty (THA', 'total hip arthroplasty']","['topical leukocyte platelet-rich plasma (L-PRP', 'local leukocyte platelet-rich plasma', 'vitamin C', 'concealed allocation either L-PRP application onto the sutured fascia or no application (control) after the THA intervention']","['complete wound healing', 'wound healing', 'concentration of keratinocyte mitogen epidermal growth factor in L-PRP', 'concentrations of platelets (5.8-fold) and leukocytes', 'blood transfusions, length of hospital stay, pain and wound infections', 'complete healing of the skin incision', 'postoperative superficial wound infections']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022567', 'cui_str': 'Keratinocyte'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.0354111,"L-PRP treatment accelerated complete wound healing after 3 weeks (seven in the L-PRP group vs. zero in the control group, p = 0.003) and after 4 weeks (12 in the L-PRP group vs. six in the control group, p = 0.037).","[{'ForeName': 'Susanne Clemen', 'Initials': 'SC', 'LastName': 'Capion', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Henrietta B L', 'Initials': 'HBL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Magnus S', 'Initials': 'MS', 'LastName': 'Ågren', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Daugaard', 'Affiliation': 'Department of Orthopaedic Surgery, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Ribel-Madsen', 'Affiliation': 'Department of Orthopaedic Surgery, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Marando', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pär Ingemar', 'Initials': 'PI', 'LastName': 'Johansson', 'Affiliation': 'Blood Bank, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Salado', 'Affiliation': 'Blood Bank, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter Max', 'Initials': 'PM', 'LastName': 'Halschou-Jensen', 'Affiliation': 'Department of Orthopaedic Surgery, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Borgwardt', 'Affiliation': 'Department of Orthopaedic Surgery, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Jens Rikardt', 'Initials': 'JR', 'LastName': 'Andersen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12967']
1667,34543803,Relaxation training with and without Comprehensive Behavioral Intervention for Tics for Tourette's disorder: A multiple baseline across participants consecutive case series.,"BACKGROUND AND OBJECTIVES


Behavioral therapies such as the Comprehensive Behavioral Intervention for Tics (CBIT) are recommended as the first-line treatment for Tourette's Disorder. This treatment approach is comprised of three central components: habit reversal training, functional assessment/intervention, and relaxation training. Despite its combined efficacy, the contribution of each therapeutic component in CBIT for reducing tic severity remains undetermined. The study evaluated the efficacy of relaxation training alone or alongside other CBIT components for reducing tic severity.
METHODS


In this multiple-baseline study, participants completed a baseline assessment (A), 4 weekly sessions of relaxation training followed by a posttreatment assessment (B), 8 weekly sessions of CBIT followed by a posttreatment assessment (C), and a 1 month posttreatment follow up assessment (D). Six participants (83% male) aged 10-18 with Tourette's Disorder completed study procedures. Primary outcomes of tic severity was the Yale Global Tic Severity Scale (YGTSS).
RESULTS


A repeated measures ANOVA revealed a significance reduction in tic severity over time (p = .010). While post-hoc tests revealed a moderate non-significant reduction in tic severity after relaxation training (d =.23), large significant reductions in tic severity were observed after the combined treatment of relaxation training and CBIT (d = 1.17) that were maintained at a 1-month follow-up visit (d = 1.53).
LIMITATIONS


Findings are limited by the small sample size.
CONCLUSIONS


While relaxation training is effective when included in conjunction with CBIT, relaxation training alone is not effective in reducing tic severity in patients with Tourette's Disorder.",2021,"While post-hoc tests revealed a moderate non-significant reduction in tic severity after relaxation training (d =.23), large significant reductions in tic severity were observed after the combined treatment of relaxation training and CBIT (d = 1.17) that were maintained at a 1-month follow-up visit (d = 1.53).
","['participants consecutive case series', ""patients with Tourette's Disorder"", ""Tics for Tourette's disorder"", ""Six participants (83% male) aged 10-18 with Tourette's Disorder completed study procedures"", 'Tics (CBIT']","['relaxation training', 'Relaxation training with and without Comprehensive Behavioral Intervention', 'relaxation training alone or alongside other CBIT components']","['tic severity', 'Yale Global Tic Severity Scale (YGTSS']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale'}]",83.0,0.0100457,"While post-hoc tests revealed a moderate non-significant reduction in tic severity after relaxation training (d =.23), large significant reductions in tic severity were observed after the combined treatment of relaxation training and CBIT (d = 1.17) that were maintained at a 1-month follow-up visit (d = 1.53).
","[{'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA; Research and Development Service, South Texas Veterans Health Care System, San Antonio, TX, USA; Department of Psychology, University of Texas at San Antonio, San Antonio, TX, USA. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': 'Tabatha H', 'Initials': 'TH', 'LastName': 'Blount', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Villarreal', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Jeslina J', 'Initials': 'JJ', 'LastName': 'Raj', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2021.101692']
1668,34543751,Transverse position. Using rotation to aid normal birth-OUTcomes following manual rotation (the TURN-OUT trial): a randomized controlled trial.,"BACKGROUND


The fetal occiput transverse position in the second stage of labor is associated with adverse maternal and perinatal outcomes. Prophylactic manual rotation in the second stage of labor is considered a safe and easy to perform procedure that has been used to prevent operative deliveries.
OBJECTIVE


This study aimed to determine the efficacy of prophylactic manual rotation in the management of the occiput transverse position for preventing operative delivery. We hypothesized that among women who are at ≥37 weeks' gestation with a baby in the occiput transverse position early in the second stage of labor, manual rotation compared with a ""sham"" rotation will reduce the rate of operative delivery.
STUDY DESIGN


A double-blinded, parallel, superiority, multicenter, randomized controlled clinical trial in 3 tertiary hospitals was conducted in Australia. The primary outcome was operative (cesarean, forceps, or vacuum) delivery. Secondary outcomes were cesarean delivery, serious maternal morbidity and mortality, and serious perinatal morbidity and mortality. Outcomes were analyzed by intention to treat. Proportions were compared using χ 2  tests adjusted for stratification variables using the Mantel-Haenszel method or Fisher exact test. Planned subgroup analyses by operator experience and technique of manual rotation (digital or whole hand rotation) were performed. The planned sample size was 416 participants (trial registration: ACTRN12613000005752).
RESULTS


Here, 160 women with a term pregnancy and a baby in the occiput transverse position in the second stage of labor, confirmed by ultrasound, were randomly assigned to receive either a prophylactic manual rotation (n=80) or a sham procedure (n=80), which was less than our original intended sample size. Operative delivery occurred in 41 of 80 women (51%) assigned to prophylactic manual rotation and 40 of 80 women (50%) assigned to a sham rotation (common risk difference, -4.2% [favors sham rotation]; 95% confidence interval, -21 to 13; P=.63). Among more experienced proceduralists, operative delivery occurred in 24 of 47 women (51%) assigned to manual rotation and 29 of 46 women (63%) assigned to a sham rotation (common risk difference, 11%; 95% confidence interval, -11 to 33; P=.33). Cesarean delivery occurred in 6 of 80 women (7.5%) in the manual rotation group and 7 of 80 women (8.7%) in the sham group. Instrumental (forceps or vacuum) delivery occurred in 35 of 80 women (44%) in the manual rotation group and 33 of 80 women (41%) in the sham group. There was no significant difference in the combined maternal and perinatal outcomes. The trial was terminated early because of limited resources.
CONCLUSION


Planned prophylactic manual rotation did not result in fewer operative deliveries. More research is needed in the use of manual rotation from the occiput transverse position for preventing operative deliveries.",2021,There were no significant differences in the combined maternal and perinatal outcomes.,"['416 participants', 'One-hundred and sixty women with a term pregnancy and a baby in the occiput transverse position in the second stage of labor, confirmed by ultrasound', 'women who are at least 37 weeks gestation with a baby in the occiput transverse position early in the second stage of labor', 'three tertiary hospitals was conducted in Australia']","['technique of manual rotation (digital or whole hand rotation', 'prophylactic manual rotation', 'Prophylactic manual rotation']","['rate of operative delivery', 'operative delivery', 'cesarean section; serious maternal morbidity and mortality; and serious perinatal morbidity and mortality', 'operative deliveries', 'Cesarean section', 'Instrumental delivery (forceps or vacuum', 'Operative delivery', 'operative (cesarean section, forceps or vacuum) delivery']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0230005', 'cui_str': 'Occipital region structure'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}]",160.0,0.589387,There were no significant differences in the combined maternal and perinatal outcomes.,"[{'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'de Vries', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Phipps', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan). Electronic address: bradley.devries@health.nsw.gov.au.""}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Kuah', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pardey', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Matthews', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ludlow', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'Rajit', 'Initials': 'R', 'LastName': 'Narayan', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Santiagu', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Earl', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wilkinson', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Carseldine', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Tooher', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGeechan', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Hyett', 'Affiliation': ""From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).""}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2021.100488']
1669,34529686,Protocol for a longitudinal study investigating the role of anxiety on academic outcomes in children on the autism spectrum.,"BACKGROUND


Children on the autism spectrum are consistently reported to underachieve compared to ability. In typically developing children, anxiety is a strong predictor of poor school performance. Despite the high prevalence of anxiety disorders among children on the spectrum, the impact of their anxiety on academic achievement is under-researched. The main aim of this project is to determine the moderating role anxiety may have in the development of academic learning behaviours (academic enablers) in children on the spectrum. This project addresses a gap in knowledge about the possible associations between anxiety and academic achievement in children on the spectrum. Understanding these associations opens up the possibility of new intervention pathways to enhance academic outcomes through anxiety reduction/prevention.
METHODS


This longitudinal study will aim to recruit 64 children on the spectrum aged 4-5 years and their parents. Information will be gathered from children, parents and teachers. Children will be randomly assigned to one of two conditions in order to experimentally manipulate anxiety levels in the sample: experimental (to receive an anxiety reduction/prevention program, N = 32) or control (no intervention/treatment as usual, N = 32). The primary outcome measures are child academic skills and enabling behaviours assessed using the Academic Competence Evaluation Scales and the WIAT-II. Anxiety will be assessed through parent and teacher report. Assessments will be conducted at baseline, post-experimental manipulation of anxiety, and within the first year of formal schooling. It is hypothesised that anxiety will moderate the relationship between autism characteristics and academic enablers.
DISSEMINATION


Results will be disseminated through peer-reviewed manuscripts and conference presentations. Lay summaries will be provided to all participants and available on the research centre website.",2021,The primary outcome measures are child academic skills and enabling behaviours assessed using the Academic Competence Evaluation Scales and the WIAT-II.,"['64 children on the spectrum aged 4-5 years and their parents', 'children on the autism spectrum', 'children on the spectrum']","['anxiety reduction/prevention program, N = 32) or control (no intervention/treatment']","['child academic skills and enabling behaviours assessed using the Academic Competence Evaluation Scales and the WIAT-II', 'Anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",64.0,0.0568755,The primary outcome measures are child academic skills and enabling behaviours assessed using the Academic Competence Evaluation Scales and the WIAT-II.,"[{'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Adams', 'Affiliation': 'Autism Centre of Excellence, Griffith University, Mount Gravatt, Queensland, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'Autism Centre of Excellence, Griffith University, Mount Gravatt, Queensland, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Simpson', 'Affiliation': 'Autism Centre of Excellence, Griffith University, Mount Gravatt, Queensland, Australia.'}, {'ForeName': 'Madonna', 'Initials': 'M', 'LastName': 'Tucker', 'Affiliation': 'AEIOU Foundation, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ron M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Rodgers', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Deb', 'Initials': 'D', 'LastName': 'Keen', 'Affiliation': 'Autism Centre of Excellence, Griffith University, Mount Gravatt, Queensland, Australia.'}]",PloS one,['10.1371/journal.pone.0257223']
1670,34542830,Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial.,"INTRODUCTION


Results from the open-label extension of the phase 3b CONQUER trial are presented to evaluate the effectiveness and safety of galcanezumab, a monoclonal antibody targeting calcitonin gene-related peptide, for up to 6 months in patients with multiple prior migraine preventive treatment failures.
METHODS


Patients were 18-75 years old with episodic or chronic migraine and 2-4 standard-of-care migraine preventive medication category failures. After 3 months of randomized treatment with galcanezumab (120 mg/month with 240 mg loading dose; n = 232) or placebo (n = 230), patients entered a 3-month open-label extension (120 mg/month galcanezumab with a blinded 240 mg loading dose for previous-placebo patients). Primary efficacy measure was mean change from double-blind baseline in monthly migraine headache days.
RESULTS


A total of 432/449 patients (96%) who entered open-label treatment completed the study. Mean change in monthly migraine headache days in the total population, which was - 1.3 for placebo and - 4.4 for galcanezumab patients at the end of double-blind treatment (p < 0.001), was - 5.2 and - 5.6, respectively, at the end of open-label treatment with galcanezumab. Among patients with episodic migraine, mean change in monthly migraine headache days had been - 0.6 for placebo and - 2.8 for galcanezumab after double-blind treatment (p < 0.001) and was - 4.5 and - 3.8, respectively, after open-label treatment. Among patients with chronic migraine, mean change in monthly migraine headache days had been - 2.5 for placebo and - 6.6 for galcanezumab after double-blind treatment (p < 0.001) and was - 6.5 and - 8.2, respectively, after open-label treatment. Adverse events were similar to those observed during double-blind placebo treatment. Review of data in elderly patients (65-75 years of age) indicated that galcanezumab was well tolerated in this age group, with no safety issues identified.
CONCLUSIONS


Galcanezumab was effective and safe during open-label treatment in patients who had experienced failures of previous migraine preventives.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT03559257.",2021,"Mean change in monthly migraine headache days in the total population, which was - 1.3 for placebo and - 4.4 for galcanezumab patients at the end of double-blind treatment (p < 0.001), was - 5.2 and - 5.6, respectively, at the end of open-label treatment with galcanezumab.","['patients with chronic migraine', 'patients with multiple prior migraine preventive treatment failures', 'patients who had experienced failures of previous migraine preventives', 'Patients were 18-75\xa0years old with episodic or chronic migraine and 2-4 standard-of-care migraine preventive medication category failures', 'patients with episodic migraine', 'elderly patients (65-75\xa0years of age', 'Patients with Multiple Previous Migraine Preventive Medication Category Failures', '432/449 patients (96%) who entered open-label treatment completed the study']","['Galcanezumab', 'placebo', '3-month open-label extension (120\xa0mg/month galcanezumab with a blinded 240\xa0mg loading dose for previous-placebo', 'galcanezumab']","['migraine headache days', 'effective and safe', 'monthly migraine headache days', 'Mean change in monthly migraine headache days', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.427899,"Mean change in monthly migraine headache days in the total population, which was - 1.3 for placebo and - 4.4 for galcanezumab patients at the end of double-blind treatment (p < 0.001), was - 5.2 and - 5.6, respectively, at the end of open-label treatment with galcanezumab.","[{'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lucas', 'Affiliation': 'Hôpital Salengro, CHU de Lille, Lille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dolezil', 'Affiliation': 'DADO MEDICAL, Prague, Czech Republic.'}, {'ForeName': 'Austin L', 'Initials': 'AL', 'LastName': 'Hand', 'Affiliation': 'IQVIA, Durham, NC, 27703, USA.'}, {'ForeName': 'Martha D', 'Initials': 'MD', 'LastName': 'Port', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Nichols', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Stroud', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Tockhorn-Heidenreich', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Holland C', 'Initials': 'HC', 'LastName': 'Detke', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. detke_holland_c@lilly.com.'}]",Advances in therapy,['10.1007/s12325-021-01911-7']
1671,34534253,Effect of warm-up and muscle fatiguing exercise on knee joint sounds in motion by vibroarthrography: A randomized crossover trial.,"Vibroarthrography measures joint sounds caused by sliding of the joint surfaces over each other. and can be affected by joint health, load and type of movement. Since both warm-up and muscle fatigue lead to local changes in the knee joint (e.g., temperature increase, lubrication of the joint, muscle activation), these may impact knee joint sounds. Therefore, this study investigates the effects of warm-up and muscle fatiguing exercise on knee joint sounds during an activity of daily living. Seventeen healthy, physically active volunteers (25.7 ± 2 years, 7 males) performed a control and an intervention session with a wash-out phase of one week. The control session consisted of sitting on a chair, while the intervention session contained a warm-up (walking on a treadmill) followed by a fatiguing exercise (modified sit-to-stand) protocol. Knee sounds were recorded by vibroarthrography (at the medial tibia plateau and at the patella) at three time points in each session during a sit-to-stand movement. The primary outcome was the mean signal amplitude (MSA, dB). Differences between sessions were determined by repeated measures ANOVA with intra-individual pre-post differences for the warm-up and for the muscle fatigue effect. We found a significant difference for MSA at the medial tibia plateau (intervention: mean 1.51 dB, standard deviation 2.51 dB; control: mean -1.28 dB, SD 2.61 dB; F = 9.5; p = .007; η2 = .37) during extension (from sit to stand) after the warm-up. There was no significant difference for any parameter after the muscle fatiguing exercise (p > .05). The increase in MSA may mostly be explained by an increase in internal knee load and joint friction. However, neuromuscular changes may also have played a role. It appears that the muscle fatiguing exercise has no impact on knee joint sounds in young, active, symptom-free participants during sit to stand.",2021,There was no significant difference for any parameter after the muscle fatiguing exercise (p > .05).,"['Seventeen healthy, physically active volunteers (25.7 ± 2 years, 7 males', 'knee joint sounds in motion by vibroarthrography']","['control session consisted of sitting on a chair, while the intervention session contained a warm-up (walking on a treadmill) followed by a fatiguing exercise (modified sit-to-stand) protocol', 'warm-up and muscle fatiguing exercise']","['mean signal amplitude (MSA, dB', 'knee joint sounds', 'internal knee load and joint friction', 'MSA at the medial tibia plateau']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0000294', 'cui_str': 'Mesna'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0162691', 'cui_str': 'Friction'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}]",17.0,0.0371421,There was no significant difference for any parameter after the muscle fatiguing exercise (p > .05).,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tenberg', 'Affiliation': 'Department of Computer Science / Therapy Sciences, University of Applied Sciences Trier, Trier, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kalo', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Niederer', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University Frankfurt am Main, Frankfurt, Germany.'}]",PloS one,['10.1371/journal.pone.0257652']
1672,34533059,Increased Blood Pressure Variability and the Risk of Probable Dementia or Mild Cognitive Impairment: A Post Hoc Analysis of the SPRINT MIND Trial.,"Background Increased systolic blood pressure variability (BPV) is associated with stroke, cardiovascular disease, and dementia and mild cognitive impairment. However, prior studies assessing the relationship between BPV and dementia or mild cognitive impairment had infrequent measurement of blood pressure or suboptimal blood pressure control. Methods and Results We performed a post hoc analysis of the SPRINT (Systolic Blood Pressure Intervention Trial) MIND (Memory and Cognition in Decreased Hypertension) trial. The primary outcome was probable dementia during follow-up. We defined our exposure period, during which blood pressures were collected, as the first 600 days of the trial, and outcomes were ascertained during the subsequent follow-up. BPV was measured as tertiles of systolic blood pressure standard deviation. We fit Cox proportional hazards models to our outcome. We included 8379 patients. The mean follow-up was 3.2±1.4 years, during which 316 (3.8%) patients developed dementia. The mean number of blood pressure measurements was 7.8, and in the tertiles of BPV, the SD was 6.3±1.6, 10.3±1.1, and 16.3±3.6 mm Hg, respectively. The rate of dementia was 2.4%, 3.6%, and 5.4% by ascending tertile, respectively ( P <0.001). In the Cox models, compared with the lowest tertile of BPV, the highest tertile of BPV increased the risk of dementia in both unadjusted (hazard ratio [HR], 2.36; 95% CI, 1.77-3.15) and adjusted (HR, 1.69; 95% CI, 1.25-2.28) models. Conclusions In a post hoc analysis of the SPRINT MIND trial, we found that higher BPV was associated with the development of probable dementia despite excellent blood pressure control. Additional research is needed to understand how to reduce BPV and if its reduction lowers the risk of cognitive impairment and dementia.",2021,"The rate of dementia was 2.4%, 3.6%, and 5.4% by ascending tertile, respectively ( P <0.001).",['8379 patients'],[],"['mean number of blood pressure measurements', 'BPV', 'Blood Pressure Variability and the Risk of Probable Dementia or Mild Cognitive Impairment', 'blood pressure or suboptimal blood pressure control', 'systolic blood pressure variability (BPV', 'rate of dementia', 'blood pressure control', 'systolic blood pressure standard deviation', 'probable dementia during follow-up']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",8379.0,0.281336,"The rate of dementia was 2.4%, 3.6%, and 5.4% by ascending tertile, respectively ( P <0.001).","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Havenon', 'Affiliation': 'Department of Neurology University of Utah Salt Lake City UT.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Anadani', 'Affiliation': 'Department of Neurology Washington University St. Louis MO.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Prabhakaran', 'Affiliation': 'Department of Neurology University of Chicago Chicago IL.'}, {'ForeName': 'Ka-Ho', 'Initials': 'KH', 'LastName': 'Wong', 'Affiliation': 'Department of Neurology University of Utah Salt Lake City UT.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yaghi', 'Affiliation': 'Department of Neurology New York University New York NY.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Rost', 'Affiliation': 'Department of Neurology Harvard University Boston MA.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.022206']
1673,34545530,Intercostal Cryo Nerve Block in Minimally Invasive Cardiac Surgery: The Prospective Randomized FROST Trial.,"INTRODUCTION


Intercostal cryo nerve block has been shown to enhance pulmonary function recovery and pain management in post-thoracotomy procedures. However, its benefit have never been demonstrated in minimal invasive thoracotomy heart valve surgery (Mini-HVS). The purpose of the study was to determine whether intraoperative intercostal cryo nerve block in conjunction with standard of care (collectively referred to hereafter as CryoNB) provided superior analgesic efficacy in patients undergoing Mini-HVS compared to standard-of-care (SOC).
METHODS


FROST was a prospective, 3:1 randomized (CryoNB vs. SOC), multicenter trial in patients undergoing Mini-HVS. The primary endpoint was the 48-h postoperative forced expiratory volume in 1 s (FEV1) result. Secondary endpoints were visual analog scale (VAS) scores for pain at the surgical site and general pain, intensive care unit and hospital length-of-stay, total opioid consumption, and allodynia at 6 months postoperatively.
RESULTS


A total of 84 patients were randomized to the two arms of the trial CryoNB (n = 65) and SOC (n = 19). Baseline Society of Thoracic Surgeons Predictive Risk of Mortality (STS PROM) score, ejection fraction, and FEV1 were similar between cohorts. A higher 48-h postoperative FEV1 result was demonstrated in the CryoNB cohort versus the SOC cohort (1.20 ± 0.46 vs. 0.93 ± 0.43 L; P = 0.02, one-sided two-sample t test). Surgical site VAS scores were similar between the CryoNB and SOC cohorts at all postoperative timepoints evaluated, but VAS scores not related to the surgical site were lower in the SOC group at 72, 94, and 120 h postoperatively. The SOC cohort had a 13% higher opioid consumption than the CryoNB cohort. One of 64 CryoNB patients reported allodynia that did not require pain medication at 10 months.
CONCLUSIONS


The results of FROST demonstrated that intercostal CryoNB provided enhanced FEV1 score at 48 h postoperatively with optimized analgesic effectiveness versus SOC. Future larger prospective randomized trials are warranted to determine whether intercostal CryoNB has an opioid-sparing effect in patients undergoing Mini-HVS.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT02922153.",2021,"Surgical site VAS scores were similar between the CryoNB and SOC cohorts at all postoperative timepoints evaluated, but VAS scores not related to the surgical site were lower in the SOC group at 72, 94, and 120 h postoperatively.","['patients undergoing Mini-HVS', '84 patients', 'patients undergoing Mini-HVS compared to standard-of-care (SOC']","['intraoperative intercostal cryo nerve block in conjunction with standard of care (collectively referred to hereafter as CryoNB', 'Invasive Cardiac Surgery', 'Intercostal Cryo Nerve Block in Minimally']","['VAS scores', 'Surgical site VAS scores', '48-h postoperative FEV1 result', 'Mortality (STS PROM) score, ejection fraction, and FEV1', 'allodynia that did not require pain medication', '48-h postoperative forced expiratory volume in 1 s (FEV1) result', 'FEV1 score', 'opioid consumption', 'visual analog scale (VAS) scores for pain at the surgical site and general pain, intensive care unit and hospital length-of-stay, total opioid consumption, and allodynia at 6 months postoperatively']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",84.0,0.12508,"Surgical site VAS scores were similar between the CryoNB and SOC cohorts at all postoperative timepoints evaluated, but VAS scores not related to the surgical site were lower in the SOC group at 72, 94, and 120 h postoperatively.","[{'ForeName': 'Wei C', 'Initials': 'WC', 'LastName': 'Lau', 'Affiliation': 'William Beaumont Hospital, 3601 West 13 Mile Road, Royal Oak, MI, 48703, USA. Wei.lau@beaumont.edu.'}, {'ForeName': 'Francis L', 'Initials': 'FL', 'LastName': 'Shannon', 'Affiliation': 'William Beaumont Hospital, 3601 West 13 Mile Road, Royal Oak, MI, 48703, USA.'}, {'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Bolling', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Romano', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Sakwa', 'Affiliation': 'Memorial Care Heart and Vascular Institute, Long Beach, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Trescot', 'Affiliation': 'The Pain and Headache Center, Eagle River, AK, USA.'}, {'ForeName': 'Luoxi', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'NAMSA, Minneapolis, MN, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Johnson', 'Affiliation': 'William Beaumont Hospital, 3601 West 13 Mile Road, Royal Oak, MI, 48703, USA.'}, {'ForeName': 'Vaughn A', 'Initials': 'VA', 'LastName': 'Starnes', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Grehan', 'Affiliation': 'United Heart and Vascular Institute-Allina, Saint Paul, MN, USA.'}]",Pain and therapy,['10.1007/s40122-021-00318-0']
1674,34545454,"Study protocol: a multicenter randomized controlled trial of the multifaceted workload reduction of the anti-adhesion barrier for diverting ileostomy in laparoscopic rectal surgery, YCOG 2005 (ADOBARRIER study).","BACKGROUND


There are few randomized controlled trials on the efficacy of spray-type anti-adhesion material during diverting ileostomy in laparoscopic rectal cancer surgery.
PURPOSE


This study will assess whether or not spraying an anti-adhesion material during diverting ileostomy could reduce the surgeon's multifaceted workload in ileostomy closure.
METHODS


Patients with laparoscopic or robotic surgery for rectal cancer scheduled for low anterior resection and diverting ileostomy will be enrolled in the ADOBARRIER study (multicenter, single-blind, randomized controlled trial). The target sample size is set at 120 cases, which will be randomly divided into an anti-adhesion material-using group and a non-using group at a ratio of 1:1. The primary endpoint is the multifaceted workload of the surgeon of ileostomy closure using SURG-TLX between groups with and without usage of the anti-adhesion material during diverting ileostomy construction; the secondly endpoint is the operative time, amount of intraoperative blood loss, degree of adhesions, and extent of intra-abdominal adhesions when the ileostomy is closed.
CONCLUSIONS


This RCT will evaluate the efficacy and safety of spray-type anti-adhesion material for diverting ileostomy construction. The results of this study are expected to facilitate decision-making regarding the use of anti-adhesion material.
TRIAL REGISTRATION


This trial was registered with the Japan Registry of Clinical Trials (jRCT) in October 2020 as jRCTs032200155.",2021,"The primary endpoint is the multifaceted workload of the surgeon of ileostomy closure using SURG-TLX between groups with and without usage of the anti-adhesion material during diverting ileostomy construction; the secondly endpoint is the operative time, amount of intraoperative blood loss, degree of adhesions, and extent of intra-abdominal adhesions when the ileostomy is closed.
","['Patients with', 'laparoscopic rectal cancer surgery']","['anti-adhesion barrier for diverting ileostomy in laparoscopic rectal surgery, YCOG', 'laparoscopic or robotic surgery for rectal cancer scheduled for low anterior resection and diverting ileostomy', 'spray-type anti-adhesion material']","['operative time, amount of intraoperative blood loss, degree of adhesions, and extent of intra-abdominal adhesions', 'multifaceted workload of the surgeon of ileostomy closure using SURG-TLX between groups with and without usage of the anti-adhesion material']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0192775', 'cui_str': 'Closure of ileostomy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1505678', 'cui_str': 'CD46 protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0520510', 'cui_str': 'Material'}]",,0.379842,"The primary endpoint is the multifaceted workload of the surgeon of ileostomy closure using SURG-TLX between groups with and without usage of the anti-adhesion material during diverting ileostomy construction; the secondly endpoint is the operative time, amount of intraoperative blood loss, degree of adhesions, and extent of intra-abdominal adhesions when the ileostomy is closed.
","[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ohya', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan. jun0926@yokohama-cu.ac.jp.'}, {'ForeName': 'Kouki', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Suwa', 'Affiliation': 'Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Ozawa', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Sumito', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Sugano', 'Affiliation': 'Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Suwa', 'Affiliation': 'Department of Surgery, Yokosuka Kyosai Hospital, Yokosuka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ishibe', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Chikara', 'Initials': 'C', 'LastName': 'Kunisaki', 'Affiliation': 'Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Endo', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}]",International journal of colorectal disease,['10.1007/s00384-021-04032-3']
1675,34545166,"Action video game training improves text reading accuracy, rate and comprehension in children with dyslexia: a randomized controlled trial.","Dynamic visual attention training using Action Video Games (AVGs) is a promising intervention for dyslexia. This study investigated the efficacy of 5 h (10 × 30 min) of AVG training in dyslexic children (aged 8-13) using 'Fruit Ninja', while exploring whether increasing attentional and eye movement demands enhanced AVG effectiveness. Regular (AVG-R; n = 22) and enhanced AVG training (AVG+; n = 23) were compared to a treatment-as-usual comparison group (n = 19) on reading, rapid naming, eye movements and visuo-temporal processing. Playing 'Fruit Ninja' for only 5 h significantly improved reading accuracy, rate, comprehension and rapid naming of both AVG groups, compared to the comparison group, though increasing attentional demands did not enhance AVG efficacy. Participants whose low contrast magnocellular-temporal processing improved most following training also showed significantly greater improvement in reading accuracy. The findings demonstrate a clear role for visual attention in reading and highlight the clinical applicability of AVGs as a fun, motivational and engaging intervention for dyslexia.",2021,"Playing 'Fruit Ninja' for only 5 h significantly improved reading accuracy, rate, comprehension and rapid naming of both AVG groups, compared to the comparison group, though increasing attentional demands did not enhance AVG efficacy.","['children with dyslexia', ""dyslexic children (aged 8-13) using 'Fruit Ninja""]","['AVG training', 'Action video game training', 'Dynamic visual attention training using Action Video Games (AVGs', 'enhanced AVG training (AVG+; n\u2009=\u200923) were compared to a treatment-as-usual comparison group (n\u2009=\u200919) on reading, rapid naming, eye movements and visuo-temporal processing']","['text reading accuracy, rate and comprehension', 'AVG efficacy', 'reading accuracy', 'reading accuracy, rate, comprehension and rapid naming']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]",,0.015278,"Playing 'Fruit Ninja' for only 5 h significantly improved reading accuracy, rate, comprehension and rapid naming of both AVG groups, compared to the comparison group, though increasing attentional demands did not enhance AVG efficacy.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Peters', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Melbourne, VIC, 3086, Australia. j.peters@latrobe.edu.au.'}, {'ForeName': 'Sheila G', 'Initials': 'SG', 'LastName': 'Crewther', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Melbourne, VIC, 3086, Australia.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Melbourne, VIC, 3086, Australia.'}, {'ForeName': 'Edith L', 'Initials': 'EL', 'LastName': 'Bavin', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Melbourne, VIC, 3086, Australia.'}]",Scientific reports,['10.1038/s41598-021-98146-x']
1676,34535714,Impact of cognitive reserve on dance intervention-induced changes in brain plasticity.,"Dance is a complex sensorimotor activity with positive effects on physical fitness, cognition, and brain plasticity in the aging population. We explored whether individual levels of cognitive reserve (CR) proxied by education moderate dance intervention (DI)-induced plasticity assessed by resting-state functional connectivity (rs-FC) changes of the sensorimotor network (SMN), and between the dorsal attention network (DAN) and anterior default mode network (aDMN). Our cohort consisted of 99 subjects, randomly assigned to either a DI group who underwent a 6-month intervention (n = 49, M age  = 69.02 ± 5.40) or a control group (n = 50, M age  = 69.37 ± 6.10). Moderation analyses revealed that CR moderated DI-induced increase of the SMN rs-FC with significant changes observed in participants with ≥ 15 years of education (b = 0.05, t(62) = 3.17, p = 0.002). Only DI alone was a significant predictor of the DAN-aDMN crosstalk change (b = 0.06, t(64) = 2.16, p = 0.035). The rs-FC increase in the SMN was correlated with an improved physical fitness measure, and changes in the DAN-aDMN connectivity were linked to better performance on figural fluency. Consistent with the passive CR hypothesis, we observed that CR correlated only with baseline behavioral scores, not their change.",2021,"The rs-FC increase in the SMN was correlated with an improved physical fitness measure, and changes in the DAN-aDMN connectivity were linked to better performance on figural fluency.","['99 subjects', 'participants with ≥']",['cognitive reserve (CR) proxied by education moderate dance intervention (DI)-induced plasticity assessed by resting-state functional connectivity'],"['DAN-aDMN crosstalk change', 'dorsal attention network (DAN) and anterior default mode network (aDMN', 'physical fitness, cognition, and brain plasticity', 'physical fitness measure, and changes in the DAN-aDMN connectivity', 'brain plasticity', 'SMN rs-FC']",[],"[{'cui': 'C2936352', 'cui_str': 'Brain Reserve'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0010357', 'cui_str': 'Cross Reactions'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C5200806', 'cui_str': 'Brain Plasticity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",99.0,0.019087,"The rs-FC increase in the SMN was correlated with an improved physical fitness measure, and changes in the DAN-aDMN connectivity were linked to better performance on figural fluency.","[{'ForeName': 'Kristína', 'Initials': 'K', 'LastName': 'Mitterová', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 62500, Brno, Czech Republic.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Klobušiaková', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 62500, Brno, Czech Republic.'}, {'ForeName': 'Alžběta', 'Initials': 'A', 'LastName': 'Šejnoha Minsterová', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 62500, Brno, Czech Republic.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Kropáčová', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 62500, Brno, Czech Republic.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Balážová', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 62500, Brno, Czech Republic.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Točík', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 62500, Brno, Czech Republic.'}, {'ForeName': 'Pavlína', 'Initials': 'P', 'LastName': 'Vaculíková', 'Affiliation': 'Department of Gymnastics and Combatives, Faculty of Sports Studies, Masaryk University, Kamenice 5, 62500, Brno, Czech Republic.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Skotáková', 'Affiliation': 'Department of Gymnastics and Combatives, Faculty of Sports Studies, Masaryk University, Kamenice 5, 62500, Brno, Czech Republic.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Grmela', 'Affiliation': 'Department of Health Promotion, Faculty of Sports Studies, Masaryk University, Kamenice 5, 62500, Brno, Czech Republic.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Rektorová', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 62500, Brno, Czech Republic. irena.rektorova@fnusa.cz.'}]",Scientific reports,['10.1038/s41598-021-97323-2']
1677,34554688,Treatment Impact on Patient-Reported Outcomes in Peripheral Neuropathic Pain: Comparing Single Intervention With Topical High-Concentration Capsaicin to Daily Oral Pregabalin.,"BACKGROUND


Peripheral neuropathic pain (PNP) is a complex, subjective experience affecting both physical and psychological aspects of functioning. Assessing patient-reported outcomes (PROs) beyond pain relief is important and aligns with the recommendations of IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials). Moreover, PRO data are key to clinical decision-making when evaluating treatment options. However, direct comparisons between such options are scarce. High-concentration capsaicin 179 mg (8% w/w) cutaneous patch (HCCP) is applied to the skin at minimum intervals of 90 days under physician supervision; alternative recommended treatments for PNP are mostly orally administered on a daily basis. The ELEVATE study directly compared HCCP with pregabalin and found noninferior efficacy of HCCP to pregabalin in relieving pain after 8 weeks, with a significantly faster onset of action and fewer systemic side effects.
OBJECTIVES


The objective of this analysis was to compare PRO outcomes defined as secondary objectives of the ELEVATE study after a single intervention with HCCP to daily oral pregabalin for 8 weeks.
STUDY DESIGN


ELEVATE was an open-label, randomized (1:1) multicenter study.
SETTING


The study included 92 sites in 22 countries in Europe and Asia.
METHODS


Five hundred fifty-nine non-diabetic  patients with PNP received a single intervention with HCCP (n = 282; 1-4 patches at baseline) or oral daily pregabalin (n = 277; 150-600 mg, 8 weeks). At baseline (Day 0) and Week 8, patients completed the following PROs in addition to the regular pain assessments: Patient Global Impression of Change (PGIC), Medical Outcomes Study Cognitive Functioning scale (MOS-Cog), Medical Outcomes Study Sleep scale (MOS-Sleep), Treatment Satisfaction Questionnaire for Medication (TSQM), and EuroQol 5-Dimensions 5-levels (EQ-5D-5L) Utility Index (EQ-UI) and Visual Analog Scale (EQ-VAS).
RESULTS


At Week 8, 76% and 75.9% of patients on HCCP and pregabalin, respectively, reported to be very much/much/minimally improved on the PGIC. HCCP application was associated with significant improvements from baseline vs. pregabalin in MOS-Cog (mean difference: 4.28 [95% CI: 2.90-5.66]; P < 0.001), EQ-VAS (3.11 [0.30-5.92]; P = 0.030), and TSQM global satisfaction (6.74 [2.29-11.20]; P = 0.029), particularly the side-effects dimension (21.23 [17.55-24.94]; P < 0.0001). No significant differences in improvements were noted for the MOS-Sleep, TSQM convenience, and EQ-UI.
LIMITATIONS


The ELEVATE study has an open-label design, with only one comparator (pregabalin); it was limited to 8 weeks. The sample size was determined for the primary endpoint.
CONCLUSIONS


A single intervention with HCCP showed benefits vs. daily pregabalin at Week 8 on several PROs. While HCCP has been approved in the United States for PNP treatment in diabetic and PHN patients, these observations provide information on how patients perceive the effects of distinct PNP treatments. They are complementing already existing knowledge on efficacy and safety of different treatment options with data on patient preferences and may help identify the appropriate treatment option in dialogue with the patients and shared decision-making.IRB Approval: At the time of the study, the trial was approved either nationally or at site level. All approvals were granted prior to the initiation of the trial. A list of Ethics Committees that approved the trial is included as a supplemental file.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01713426.",2021,"No significant differences in improvements were noted for the MOS-Sleep, TSQM convenience, and EQ-UI.
","['Five hundred fifty-nine non-diabetic\xa0 patients with PNP received a', 'diabetic and PHN patients']","['Topical High-Concentration Capsaicin to Daily Oral Pregabalin', 'comparator (pregabalin', 'Single Intervention', 'HCCP to daily oral pregabalin', 'single intervention with HCCP (n = 282; 1-4 patches at baseline) or oral daily pregabalin', 'HCCP to pregabalin', 'EQ-5D-5L', 'High-concentration capsaicin 179 mg (8% w/w) cutaneous patch (HCCP', 'pregabalin', 'HCCP with pregabalin', 'HCCP']","['relieving pain', 'PRO outcomes', 'regular pain assessments: Patient Global Impression of Change (PGIC), Medical Outcomes Study Cognitive Functioning scale (MOS-Cog), Medical Outcomes Study Sleep scale (MOS-Sleep), Treatment Satisfaction Questionnaire for Medication (TSQM), and EuroQol 5-Dimensions 5-levels', 'MOS-Sleep, TSQM convenience, and EQ-UI', 'Peripheral Neuropathic Pain', 'TSQM global satisfaction', 'Utility Index (EQ-UI) and Visual Analog Scale (EQ-VAS', 'EQ-VAS']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0241148', 'cui_str': 'Cutaneous plaque'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",277.0,0.133179,"No significant differences in improvements were noted for the MOS-Sleep, TSQM convenience, and EQ-UI.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Viel', 'Affiliation': ""Centre d'Étude et de Traitement de la Douleur, Pôle A.R.D.U., Centre Hospitalier Universitaire, France.""}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Eerdekens', 'Affiliation': 'Grünenthal GmbH, Aachen, Germany.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Kandaswamy', 'Affiliation': 'Grünenthal GmbH, Aachen, Germany.'}]",Pain physician,[]
1678,34559359,Sedation Effects Produced by a Ciprofol Initial Infusion or Bolus Dose Followed by Continuous Maintenance Infusion in Healthy Subjects: A Phase 1 Trial.,"INTRODUCTION


The effects of continuous infusions of ciprofol on its pharmacodynamic and pharmacokinetic properties and safety profiles in healthy Chinese subjects were evaluated.
METHODS


In this open-label, randomized, two-way cross-over study, subjects received initial doses of continuous ciprofol/propofol as an infusion for 30 min in part 1 (n = 8) and a bolus dose in part 2 (n = 8) followed by maintenance infusions for a total of 4 h in part 1 and 12 h in part 2. Each subject participated in both parts with a washout time of at least 40 h.
RESULTS


The safety and tolerability parameters of ciprofol were similar to those of propofol, and all treatment-emergent adverse events were mild. The incidences of injection pain and respiratory depression in subjects given ciprofol were lower than those receiving propofol. The pharmacokinetic parameters C max , t max , t 1/2 , λz and MRT for ciprofol and propofol were similar, while CL, V d  and V ss  were statistically significantly different. Pharmacodynamic parameters including the Richmond Agitation Sedation Scale and bispectral index profiles of ciprofol were similar to those of propofol.
CONCLUSION


Ciprofol has potential for clinical application for continuous intravenous infusion to maintain sedation for 12 h with the same safety, tolerability and efficacy as propofol.",2021,"The safety and tolerability parameters of ciprofol were similar to those of propofol, and all treatment-emergent adverse events were mild.","['healthy Chinese subjects', 'Healthy Subjects']","['Ciprofol Initial Infusion or Bolus Dose Followed by Continuous Maintenance Infusion', 'continuous ciprofol/propofol', 'propofol', 'ciprofol']","['Richmond Agitation Sedation Scale and bispectral index profiles of ciprofol', 'safety, tolerability and efficacy', 'safety and tolerability parameters of ciprofol', 'pharmacodynamic and pharmacokinetic properties and safety profiles', 'pharmacokinetic parameters C max , t max , t 1/2 , λz and MRT for ciprofol and propofol', 'injection pain and respiratory depression']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0024943', 'cui_str': 'Mauritania'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}]",,0.00956524,"The safety and tolerability parameters of ciprofol were similar to those of propofol, and all treatment-emergent adverse events were mild.","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Clinical Trials Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Ou', 'Affiliation': 'Department of Intensive Care Unit, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Teng', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Shiqing', 'Initials': 'S', 'LastName': 'Shu', 'Affiliation': 'Clinical Trials Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Clinical Trials Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Clinical Trials Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Intensive Care Unit, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China. kangyan_hx@163.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'Clinical Trials Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China. miaosiyi1971@163.com.'}]",Advances in therapy,['10.1007/s12325-021-01914-4']
1679,34547501,"Comment on ""Effect of a perioperative immune-enhancing diet in clean-contaminated head and neck cancer surgery: A randomized controlled trial"" (Int J Surg 2021; 93:106051).",,2021,,['clean-contaminated head and neck cancer surgery'],['perioperative immune-enhancing diet'],[],"[{'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",[],,0.14167,,"[{'ForeName': 'Zhouying', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Laboratory Department, YiWu Central Hospital, Zhejiang, 322000, China. Electronic address: huangzhouying123@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106114']
1680,34558534,Effect of vocal respiratory training on respiratory function and respiratory neural plasticity in patients with cervical spinal cord injury: a randomized controlled trial.,"In previous studies, researchers have used singing to treat respiratory function in patients with spinal cord injury. However, few studies have examined the way in which vocal training affects respiratory neural plasticity in patients with spinal cord injury. Vocal respiratory training (VRT) is a type of vocal muscle-related treatment that is often a component of music therapy (MT) and focuses on strengthening respiratory muscles and improving lung function. In this randomized controlled study, we analyzed the therapeutic effects of VRT on respiratory dysfunction at 3 months after cervical spinal cord injury. Of an initial group of 37 patients, 26 completed the music therapy intervention, which comprised five 30-minute sessions per week for 12 weeks. The intervention group (n = 13) received VRT training delivered by professional certified music therapists. The control group (n = 13) received respiratory physical therapy delivered by professional physical therapists. Compared with the control group, we observed a substantial increase in respiratory function in the intervention group after the 12-week intervention. Further, the nerve fiber bundles in the respiratory center in the medulla exhibited a trend towards increased diversification, with an increased number, path length, thickness, and density of nerve fiber bundles. These findings provide strong evidence for the effect of music therapeutic VRT on neural plasticity. This study was approved by the Ethics Committee of China Rehabilitation Research Center (approval No. 2020-013-1) on April 1, 2020, and was registered with the Chinese Clinical Trial Registry (registration No. ChiCTR2000037871) on September 2, 2020.",2022,"Compared with the control group, we observed a substantial increase in respiratory function in the intervention group after the 12-week intervention.","['patients with spinal cord injury', 'patients with cervical spinal cord injury', 'cervical spinal cord injury']","['respiratory physical therapy delivered by professional physical therapists', 'VRT', 'music therapy intervention', 'Vocal respiratory training (VRT', 'vocal training', 'vocal respiratory training', 'VRT training delivered by professional certified music therapists']","['respiratory function', 'respiratory function and respiratory neural plasticity', 'number, path length, thickness, and density of nerve fiber bundles', 'respiratory dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0586937', 'cui_str': 'Music therapist'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0027749', 'cui_str': 'Nerve fiber'}, {'cui': 'C1260922', 'cui_str': 'Abnormal breathing'}]",,0.0164879,"Compared with the control group, we observed a substantial increase in respiratory function in the intervention group after the 12-week intervention.","[{'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; China Rehabilitation Science Institute; Beijing Key Laboratory of Neural Injury and Rehabilitation; Center of Neural Injury and Repair, Beijing Institute for Brain Disorders; Music Therapy Center, Department of Psychology, China Rehabilitation Research Center, Beijing, China.'}, {'ForeName': 'Wei-Yong', 'Initials': 'WY', 'LastName': 'Yu', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; Department of Imaging, China Rehabilitation Research Center, Beijing, China.'}, {'ForeName': 'Wen-Jia', 'Initials': 'WJ', 'LastName': 'Teng', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; China Rehabilitation Science Institute; Beijing Key Laboratory of Neural Injury and Rehabilitation; Center of Neural Injury and Repair, Beijing Institute for Brain Disorders, Beijing, China.'}, {'ForeName': 'Yi-Chuan', 'Initials': 'YC', 'LastName': 'Song', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; Music Therapy Center, Department of Psychology, China Rehabilitation Research Center, Beijing, China.'}, {'ForeName': 'De-Gang', 'Initials': 'DG', 'LastName': 'Yang', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; Department of Spinal and Neural Functional Reconstruction, China Rehabilitation Research Center, Beijing, China.'}, {'ForeName': 'Hong-Wei', 'Initials': 'HW', 'LastName': 'Liu', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; Department of Spinal and Neural Functional Reconstruction, China Rehabilitation Research Center, Beijing, China.'}, {'ForeName': 'Song-Huai', 'Initials': 'SH', 'LastName': 'Liu', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; Music Therapy Center, Department of Psychology, China Rehabilitation Research Center, Beijing, China.'}, {'ForeName': 'Xiao-Bing', 'Initials': 'XB', 'LastName': 'Li', 'Affiliation': 'Department of Music Artificial Intelligence and Music Scientific Technology, Central Conservatory of Music, Beijing, China.'}, {'ForeName': 'Wen-Zhu', 'Initials': 'WZ', 'LastName': 'Wang', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; China Rehabilitation Science Institute; Beijing Key Laboratory of Neural Injury and Rehabilitation; Center of Neural Injury and Repair, Beijing Institute for Brain Disorders, Beijing, China.'}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; China Rehabilitation Science Institute; Beijing Key Laboratory of Neural Injury and Rehabilitation; Center of Neural Injury and Repair, Beijing Institute for Brain Disorders, Beijing, China.'}]",Neural regeneration research,['10.4103/1673-5374.324856']
1681,34558533,Effects of acupuncture stimulation on brain activation induced by cue-elicited alcohol craving.,"Acupuncture has been shown to be effective on alcohol use disorder. However, the underlying mechanism remains poorly understood. To investigate the effects of Shenmen (HT7) acupoint on brain activation induced by cue-elicited alcohol craving, 30 right-handed healthy light to moderate alcohol drinkers were recruited from the community. They were randomly assigned to undergo acupuncture either at HT7 (experimental acupoint, n = 15) or Jingqu (LU8, control acupoint, n = 15) acupoints. This randomized controlled study was performed in Daegu Haany University and Daegu-Gyeongbuk Medical Innovation Foundation, Republic of Korea. Recruitment and data collection were conducted from December 2018 to May 2019. The results showed that after acupuncture at HT7 acupoint, the activation of orbitofrontal cortex and dorsolateral prefrontal cortex was greatly increased, while the activation of dorsolateral prefrontal cortex was obviously reduced, and subject's craving for alcohol was reduced when he/she seeing alcohol-related video clips involving various alcohols (beer, wine, or soju) or drinking scenarios. Acupuncture at HT7 more greatly reduced subject's alcohol cravings than acupuncture at LU8 acupoint. These findings suggest that acupuncture can improve the self-control of mild to moderate social drinkers through the activation of the orbitofrontal cortex and dorsolateral prefrontal cortex, thereby reducing the craving for alcohol. The study protocol was approved by the Institutional Review Board of Daegu Haany University Korean Medicine Hospital, Republic of Korea (approval No. DHUMC-D-18026-PRO-02) on November 30, 2018.",2022,Acupuncture at HT7 more greatly reduced subject's alcohol cravings than acupuncture at LU8 acupoint.,"['30 right-handed healthy light to moderate alcohol drinkers', 'Daegu Haany University Korean Medicine Hospital, Republic of Korea (approval', 'Daegu Haany University and Daegu-Gyeongbuk Medical Innovation Foundation, Republic of Korea']","['Acupuncture', 'acupuncture stimulation', 'Shenmen (HT7) acupoint', 'acupuncture', 'acupuncture either at HT7 (experimental acupoint, n = 15) or Jingqu (LU8, control acupoint, n = 15) acupoints']","['activation of dorsolateral prefrontal cortex', ""subject's alcohol cravings"", 'brain activation induced by cue-elicited alcohol craving', 'activation of orbitofrontal cortex and dorsolateral prefrontal cortex']","[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0450571', 'cui_str': 'HT7'}, {'cui': 'C0450472', 'cui_str': 'LU8'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0152301', 'cui_str': 'Structure of orbital gyrus'}]",,0.0207046,Acupuncture at HT7 more greatly reduced subject's alcohol cravings than acupuncture at LU8 acupoint.,"[{'ForeName': 'Hyeok Gyu', 'Initials': 'HG', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Eulji University, Gyeonggi, Republic of Korea.'}, {'ForeName': 'Seong Hun', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Anatomy and Histology, College of Oriental Medicine, Daegu Haany University, Gyeongsan, Republic of Korea.'}, {'ForeName': 'Joon Ho', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation, Gyeongbuk Regional Rehabilitation Hospital, Gyeongsan, Republic of Korea.'}, {'ForeName': 'Chae Ha', 'Initials': 'CH', 'LastName': 'Yang', 'Affiliation': 'Department of Physiology, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.'}, {'ForeName': 'Mi Young', 'Initials': 'MY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Biomedical Science, Daegu Haany University, Gyeongsan, Republic of Korea.'}]",Neural regeneration research,['10.4103/1673-5374.324849']
1682,34562231,"AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol.","INTRODUCTION


The safety and efficacy of both abobotulinumtoxinA and onabotulinumtoxinA for upper limb spasticity are well established, but head-to-head comparisons are lacking.
METHODS


DIRECTION is an international, randomized, double-blind, crossover study comparing the safety and efficacy of abobotulinumtoxinA with onabotulinumtoxinA in the management of upper limb spasticity at doses at or near maximum recommended in product labelling. Participants (18-75 years) will be randomized (1:1) to either one cycle of abobotulinumtoxinA (900U) followed by onabotulinumtoxinA (360U) or vice versa. To maintain blinding, a fixed volume (3.6 ml) will be injected into the target upper limb muscles (four wrist and finger flexors and biceps brachii). The second treatment cycle will begin at Week 12 if retreatment criteria are fulfilled, and if not, they will be reassessed every 4 weeks until they meet retreatment parameters.
PLANNED OUTCOMES


The primary hypothesis is that there is comparable safety between products; non-inferiority will be tested based on treatment-emergent adverse event (TEAE) rates from injection to Week 12. A secondary hypothesis is that abobotulinumtoxinA has longer duration of effect than onabotulinumtoxinA. This hypothesis will be tested with secondary efficacy endpoints, including injection cycle duration, Modified Ashworth Scale, Disability Assessment Scale and Physician Global Assessment.
TRIAL REGISTRATION


EudraCT ( http://eudract.ema.europa.eu ): 2021-000161-32 and Clinicaltrials.gov ( http://clinicaltrials.gov ): NCT04936542. Overview of the study protocol by the principal investigator (MP4 185265 KB).",2021,"This hypothesis will be tested with secondary efficacy endpoints, including injection cycle duration, Modified Ashworth Scale, Disability Assessment Scale and Physician Global Assessment.
","['Adults with Upper Limb Spasticity', 'Participants (18-75\xa0years']","['abobotulinumtoxinA', 'AbobotulinumtoxinA Versus OnabotulinumtoxinA', 'onabotulinumtoxinA', 'abobotulinumtoxinA with onabotulinumtoxinA', 'abobotulinumtoxinA and onabotulinumtoxinA', 'abobotulinumtoxinA (900U) followed by onabotulinumtoxinA (360U) or vice versa']","['injection cycle duration, Modified Ashworth Scale, Disability Assessment Scale and Physician Global Assessment', 'safety and efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.40106,"This hypothesis will be tested with secondary efficacy endpoints, including injection cycle duration, Modified Ashworth Scale, Disability Assessment Scale and Physician Global Assessment.
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Esquenazi', 'Affiliation': 'MossRehab & Albert Einstein Medical Center, Elkins Park, PA, 19027, USA. aesquena@einstein.edu.'}, {'ForeName': 'Ziyad', 'Initials': 'Z', 'LastName': 'Ayyoub', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, 90242, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Verduzco-Gutierrez', 'Affiliation': 'Joe R. and Teresa Lozano Long School of Medicine, The University of Texas Health Science Center at San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Maisonobe', 'Affiliation': 'Ipsen, 92100, Boulogne-Billancourt, France.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Otto', 'Affiliation': 'Ipsen, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Atul T', 'Initials': 'AT', 'LastName': 'Patel', 'Affiliation': 'Kansas Institute of Research, Overland Park, KS, 66211, USA.'}]",Advances in therapy,['10.1007/s12325-021-01896-3']
1683,34562208,"A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of AlphaWave ®  L-Theanine on Stress in a Healthy Adult Population.","INTRODUCTION


Stress is a complex life occurrence essential for survival and goal achievement but can be damaging in excess. Because of the high prevalence of stress in North America, a safe supplement that effectively reduces stress is in demand. The objective of this study was to investigate the efficacy and safety of AlphaWave ®  L-Theanine on whole-scalp and frontal alpha power, midline theta power, and salivary cortisol in healthy, moderately stressed adults.
METHODS


This was a randomized, triple-blind, placebo-controlled, crossover study that consisted of two study periods with a 7-day washout. A single dose of AlphaWave ®  L-Theanine (200 mg) or placebo was administered. To induce stress, a mental arithmetic test (MAT) was administered before and after the dose. Electroencephalogram, salivary cortisol, blood pressure, heart rate, self-reported stress, adverse events, clinical chemistry, and hematology were assessed to evaluate efficacy and safety.
RESULTS


Increases in heart rate, blood pressure, and self-reported stress and state anxiety indicated that participants experienced stress during the MAT. AlphaWave ®  L-Theanine led to a greater increase in frontal region and whole-scalp alpha power 3 h post-dose compared to placebo (p ≤ 0.050). Within groups, there were increases in alpha power, at 3 h with AlphaWave ®  L-Theanine, over the whole recording and during the eyes-open portions (p ≤ 0.048) of the alpha task. The changes in alpha wave activity are supported by greater decreases in salivary cortisol 1 h post-dose (p < 0.001) with AlphaWave ®  L-Theanine compared to placebo.
CONCLUSION


This study was conducted during the SARS-CoV-2 pandemic, which has had a rapid and significant effect on both physical and mental health around the world. A single dose of AlphaWave ®  L-Theanine significantly increased frontal region alpha power compared to placebo in response to an acute stress challenge. These changes are indicative of relaxation in the brain and suggest a calming response. AlphaWave ®  L-Theanine was found to be safe and well tolerated by participants.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT04706494.",2021,AlphaWave ®  L-Theanine led to a greater increase in frontal region and whole-scalp alpha power 3 h post-dose compared to placebo (p ≤ 0.050).,"['Healthy Adult Population', 'healthy, moderately stressed adults']","['Placebo', 'placebo', 'AlphaWave ®  L-Theanine']","['frontal region alpha power', 'frontal region and whole-scalp alpha power', 'safe and well tolerated', 'alpha power', 'heart rate, blood pressure, and self-reported stress and state anxiety', 'whole-scalp and frontal alpha power, midline theta power, and salivary cortisol', 'efficacy and safety', 'salivary cortisol', 'Electroencephalogram, salivary cortisol, blood pressure, heart rate, self-reported stress, adverse events, clinical chemistry, and hematology']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0076380', 'cui_str': 'theanine'}]","[{'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008000', 'cui_str': 'Clinical Chemistry'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}]",,0.1067,AlphaWave ®  L-Theanine led to a greater increase in frontal region and whole-scalp alpha power 3 h post-dose compared to placebo (p ≤ 0.050).,"[{'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science Inc., 255 Queens Ave, London, ON, N6A 5R8, Canada. mevans@kgkscience.com.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'McDonald', 'Affiliation': 'KGK Science Inc., 255 Queens Ave, London, ON, N6A 5R8, Canada.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': 'Ethical Naturals, Inc., 2731 Fair Oaks Ave, Redwood City, CA, 94063, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Crowley', 'Affiliation': 'KGK Science Inc., 255 Queens Ave, London, ON, N6A 5R8, Canada.'}, {'ForeName': 'Najla', 'Initials': 'N', 'LastName': 'Guthrie', 'Affiliation': 'KGK Science Inc., 255 Queens Ave, London, ON, N6A 5R8, Canada.'}]",Neurology and therapy,['10.1007/s40120-021-00284-x']
1684,34571264,The influence of hepatitis C virus eradication on hepatocarcinogenesis in patients with hemophiliaHCC after HCV eradication in hemophilia.,"INTRODUCTION AND OBJECTIVES


Hepatitis C virus (HCV) infections in patients with hemophilia lead to the development of hepatocellular carcinoma (HCC) at a relatively younger age than that in patients without hemophilia. Although recent progress in direct-acting-antivirals has facilitated a high rate of sustained virological response (SVR), the clinical influence of HCV eradication in hemophilia patients remains unclear. This study aimed to compare the clinical outcomes of SVR against HCV in patients with and without hemophilia.
PATIENTS AND METHODS


The study enrolled 699 patients who achieved SVR after HCV antiviral treatment. Patients were divided into two groups: 78 patients with hemophilia (H group) and 621 patients without hemophilia (NH group). We evaluated patient characteristics, clinical outcomes, and the cumulative incidence of HCC after SVR.
RESULTS


Compared with the NH group, patients in the H-group were significantly younger and had a lower hepatic fibrosis score. No difference was found in the incidence of liver-related disease or overall death between the two groups over a mean follow-up period of 7 years. Four patients in the H group and 36 patients in the NH group were diagnosed with HCC after SVR. Multivariate analysis showed that male sex, age, and cirrhosis were significant risk factors for HCC incidence. There was no significant difference in the cumulative incidence of HCC after propensity-score matching adjusting for the risk factors of HCC between the two groups.
CONCLUSION


Hemophilia is not a significant risk factor for hepatocarcinogenesis after SVR against HCV.",2021,No difference was found in the incidence of liver-related disease or overall death between the two groups over a mean follow-up period of 7 years.,"['patients with hemophilia lead to the development of hepatocellular carcinoma (HCC) at a relatively younger age than that in patient without hemophilia', 'patients with hemophilia: HCC after HCV eradication in hemophilia', 'Four patients in the H group and 36 patients in the NH group were diagnosed with HCC after SVR', 'patients with and without hemophilia', 'Patients were divided into two groups: 78 patients with hemophilia (H group) and 621 patients without hemophilia (NH group', 'hemophilia patients', '699 patients who achieved SVR after HCV antiviral treatment']","['NH', 'hepatitis C virus eradication', 'SVR against HCV']","['cumulative incidence of HCC', 'hepatic fibrosis score', 'incidence of liver-related disease or overall death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}]","[{'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",699.0,0.0186506,No difference was found in the incidence of liver-related disease or overall death between the two groups over a mean follow-up period of 7 years.,"[{'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Inukai', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Imai', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine. Electronic address: norihiro.imai@gmail.com.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Ishizu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Honda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Okamoto', 'Affiliation': 'Department of Hematology and Oncology, Nagoya University Graduate School of Medicine.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kanematsu', 'Affiliation': 'Department of Clinical Laboratory, Nagoya University Hospital.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Transfusion Medicine, Nagoya University Hospital.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Matsushita', 'Affiliation': 'Department of Clinical Laboratory, Nagoya University Hospital; Department of Transfusion Medicine, Nagoya University Hospital.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Ishigami', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Fujishiro', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine.'}]",Annals of hepatology,['10.1016/j.aohep.2021.100545']
1685,34571263,"Patient expectations shape convalescence after major liver surgery - A prospective, randomized study.","BACKGROUND


Several studies suggest an important influence of patient expectations on outcomes. We hypothesized that patient expectations with regard to length of postoperative stay influence convalescence after liver resections.
METHOD


This prospective, randomized study compared patients who were preoperatively either informed to be expected to stay 7-10 days (short arm) or 12-16 days (long arm) after major liver resections (≥4 segments). Additionally, psychological traits were assessed using questionnaires and the time to fulfillment of objective discharge criteria [oral analgesics only, first bowel movement, ability to tolerate solid food, full mobilization, no complications which need general anesthesia (>CD IIIa)] was defined as the primary endpoint.
RESULTS


Patients in the short arm reached the objective discharge criteria after 8.39 days (SD 3.60), while patients in the long arm needed 12.73 days (SD 3.43) (p = 0.001). The actual length of stay in the short arm was 12.00 (IQR 8-16) and 19.3 days in the long arm (IQR 14-26) (p = 0.008). A more pronounced self-efficacy correlated with earlier fulfillment of the objective discharge criteria (p = 0.048), whereas patients placing a high value on their health needed more time (p = 0.049).
CONCLUSION


The expectation of a shorter length of stay results in a quicker objective, physical patient convalescence after major liver resections.",2021,"A more pronounced self-efficacy correlated with earlier fulfillment of the objective discharge criteria (p = 0.048), whereas patients placing a high value on their health needed more time (p = 0.049).
",['patients who were preoperatively either informed to be expected to stay 7-10 days (short arm) or 12-16 days (long arm) after major liver resections (≥4 segments'],[],"['self-efficacy', 'time to fulfillment of objective discharge criteria [oral analgesics only, first bowel movement, ability to tolerate solid food, full mobilization, no complications which need general anesthesia (>CD IIIa', 'actual length of stay', 'objective discharge criteria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0575519', 'cui_str': 'Long upper limb'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0441635', 'cui_str': 'Segment'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0453855', 'cui_str': 'Solid food'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0200564,"A more pronounced self-efficacy correlated with earlier fulfillment of the objective discharge criteria (p = 0.048), whereas patients placing a high value on their health needed more time (p = 0.049).
","[{'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Börner', 'Affiliation': 'Ludwig-Maximilians-University, Department of General, Visceral and Transplantation Surgery, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Weniger', 'Affiliation': 'Ludwig-Maximilians-University, Department of General, Visceral and Transplantation Surgery, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Nossek', 'Affiliation': 'Ludwig-Maximilians-University, Department of Psychology, LMU Center for Leadership and People Management, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kuonath', 'Affiliation': 'Ludwig-Maximilians-University, Department of Psychology, LMU Center for Leadership and People Management, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schoenberg', 'Affiliation': 'Ludwig-Maximilians-University, Department of General, Visceral and Transplantation Surgery, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Bösch', 'Affiliation': 'Ludwig-Maximilians-University, Department of General, Visceral and Transplantation Surgery, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Angele', 'Affiliation': 'Ludwig-Maximilians-University, Department of General, Visceral and Transplantation Surgery, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Frey', 'Affiliation': 'Ludwig-Maximilians-University, Department of Psychology, LMU Center for Leadership and People Management, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Werner', 'Affiliation': 'Ludwig-Maximilians-University, Department of General, Visceral and Transplantation Surgery, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Guba', 'Affiliation': 'Ludwig-Maximilians-University, Department of General, Visceral and Transplantation Surgery, Germany. Electronic address: Markus.Guba@med.uni-muenchen.de.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106128']
1686,34571194,A Motivational Interviewing Intervention Improves Physical Symptoms in Patients with Heart Failure: A Secondary Outcome Analysis of the Motivate-HF Randomized Controlled Trial.,"CONTEXT


Heart failure (HF) patients experience high burden of physical symptoms during their disease trajectory.
OBJECTIVE


To evaluate the effects of Motivational Interviewing (MI) on the burden of physical symptoms in HF patients.
METHODS


We performed a secondary analysis of data from the MOTIVATE-HF randomized controlled trial. A sample of 510 patients (median 74 years, 58% male) and their caregivers (median 55 years, 75.5% female) was randomly allocated to Arm 1 (MI only for patients), Arm 2 (MI for patients and caregivers), and Arm 3 (standard of care). The MI intervention consisted of one face-to-face session plus three telephone calls conducted within two months from enrollment. Symptoms' burden was assessed with the Heart Failure Somatic Perception Scale (HFSPS) with the dimensions of Chest Discomfort, Dyspnea, Early and subtle and Edema. Data were collected at baseline and at 3, 6, 9, and 12 months after enrollment.
RESULTS


At 12 months, Chest Discomfort improved in Arms 1 and 2 vs Arm 3 (Δ: -8.13, 95% CI: -14.61; -1.65). Dyspnea improved in Arms 1 and 2 vs Arm 3 both at 9 and 12 months (Δ: -7, 95% CI: -13.18; -0.82 and -6.78, 95% CI: -13.19; -0.38); HFSPS total score improved in Arm 1 and Arm 2 vs Arm 3 at 9 months (Δ: -4.55, 95% CI: -9.05; -0.05). Over 1 year, Chest Discomfort and HFSPS total score in Arm 2 improved compared to Arm 3 (β= -2.61, 95% CI: -4.21; -1.00, P = 0.0015 and β=-1.35, 95% CI: -2.50; -0.21, P = 0.02).
CONCLUSION


MI reduces the burden of physical HF symptoms, particularly when caregivers are involved in the intervention.",2021,"Dyspnea improved in Arms 1 and 2 vs Arm 3 both at 9 and 12 months (Δ: -7, 95%CI: -13.18; -0.82 and -6.78, 95%CI: -13.19; -0.38); HFSPS total score improved in Arm 1 and Arm 2 vs Arm 3 at 9 months (Δ: -4.55, 95%CI: -9.05; -0.05).","['HF patients', '510 patients (median 74 years, 58% male) and their caregivers (median 55 years, 75.5% female', 'Patients with Heart Failure']","['Motivational Interviewing (MI', 'Motivational Interviewing Intervention']","['HFSPS total score', 'Dyspnea', 'Physical Symptoms', 'burden of physical HF symptoms', 'Chest Discomfort and HFSPS total score', 'Heart Failure Somatic Perception Scale (HFSPS) with the dimensions of Chest Discomfort, Dyspnea, Early and subtle and Edema', 'Chest Discomfort', 'physical symptoms', 'burden of physical symptoms']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0235710', 'cui_str': 'Chest discomfort'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",510.0,0.184495,"Dyspnea improved in Arms 1 and 2 vs Arm 3 both at 9 and 12 months (Δ: -7, 95%CI: -13.18; -0.82 and -6.78, 95%CI: -13.19; -0.38); HFSPS total score improved in Arm 1 and Arm 2 vs Arm 3 at 9 months (Δ: -4.55, 95%CI: -9.05; -0.05).","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Caggianelli', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Iovino', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy; School of Nursing, Midwifery and Paramedicine Faculty of Health Science (P.I., G.L.), Australian Catholic University, Melbourne, Australia. Electronic address: paolo.iovino@uniroma2.it.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rebora', 'Affiliation': 'Bicocca Bioinformatics, Biostatistics and Bioimaging Centre - B4 School of Medicine and Surgery (P.R., G.O.), University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Occhino', 'Affiliation': 'Bicocca Bioinformatics, Biostatistics and Bioimaging Centre - B4 School of Medicine and Surgery (P.R., G.O.), University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Zeffiro', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Locatelli', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy; School of Nursing, Midwifery and Paramedicine Faculty of Health Science (P.I., G.L.), Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Ausili', 'Affiliation': 'Department of Medicine and Surgery (D.A.), University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Alvaro', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing (B.R.), University of Pennsylvania, Philadelphia, PA, USA; Mary McKillop Institute of Health Research (B.R.), Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Ercole', 'Initials': 'E', 'LastName': 'Vellone', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2021.09.006']
1687,34571144,Benefits of intraoperative music on orthopedic surgeries under spinal anesthesia: A randomized clinical trial.,"OBJECTIVE


To determine whether instrumental music influences the anxiety status and intraoperative sedative requirements of a patient DESIGN: A single center, prospective, randomized controlled trial SETTING: Patients between 18 and 65 years, physical status of American Society of Anesthesiologists (ASA I or II) who underwent lower limb orthopedic surgery under spinal anesthesia.
INTERVENTIONS


Patients were assigned to one of two groups: (1) Music Group: patients hearing instrumental music through a headset during the entire procedure or (2) No Music Group: patients wearing headphones without music MAIN OUTCOME MEASURES: Before and after the procedure, the anxiety status of the patient was assessed using the State-Trait Anxiety Inventory, and intraoperative sedative drug consumption was quantified.
RESULTS


A total of 107 patients were analyzed. A significant reduction in anxiety in the Music Group patients after surgery (p = 0.023) was found. Patients in this group also required less additional medication for intraoperative sedation (p = 0.004), and 88.9% of Music Group patients self-reported that music helped them remain calm during the procedure. Most patients in both groups agreed that music should be used during surgical procedures (98.2% and 94.3% in Music and No Music Groups, respectively) CONCLUSIONS: This study showed that listening to instrumental music during lower limb orthopedic surgery caused a reduction in anxiety and sedative requirements. Patients also self-reported a positive music-related experience.",2021,"Patients in this group also required less additional medication for intraoperative sedation (p = 0.004), and 88.9% of Music Group patients self-reported that music helped them remain calm during the procedure.","['Patients between 18 and 65 years, physical status of American Society of Anesthesiologists (ASA I or II) who underwent lower limb orthopedic surgery under spinal anesthesia', 'Orthopedic Surgeries', 'A total of 107 patients were analyzed']","['Intraoperative Music', 'Music Group: patients hearing instrumental music through a headset during the entire procedure or (2']","['anxiety and sedative requirements', 'anxiety', 'State-Trait Anxiety Inventory, and intraoperative sedative drug consumption', 'additional medication for intraoperative sedation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]",107.0,0.0787741,"Patients in this group also required less additional medication for intraoperative sedation (p = 0.004), and 88.9% of Music Group patients self-reported that music helped them remain calm during the procedure.","[{'ForeName': 'Liana Maria Tôrres de Araújo', 'Initials': 'LMTA', 'LastName': 'Azi', 'Affiliation': 'Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Bahia, Brazil. Electronic address: liana.araujo@ufba.br.'}, {'ForeName': 'Matheus Lemos', 'Initials': 'ML', 'LastName': 'Azi', 'Affiliation': 'Manoel Victorino Hospital, Secretary of Health for the State of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Matheus Melo', 'Initials': 'MM', 'LastName': 'Viana', 'Affiliation': 'College of Tecnology and Sciences (FTC), Salvador, Bahia, Brazil.'}, {'ForeName': 'André Luiz Parrilha', 'Initials': 'ALP', 'LastName': 'Panont', 'Affiliation': 'College of Tecnology and Sciences (FTC), Salvador, Bahia, Brazil.'}, {'ForeName': 'Ricardo Messias F', 'Initials': 'RMF', 'LastName': 'Oliveira', 'Affiliation': 'Manoel Victorino Hospital, Secretary of Health for the State of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sadigursky', 'Affiliation': 'Manoel Victorino Hospital, Secretary of Health for the State of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Daniel Figueiredo', 'Initials': 'DF', 'LastName': 'Alencar', 'Affiliation': 'Manoel Victorino Hospital, Secretary of Health for the State of Bahia, Salvador, Bahia, Brazil.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102777']
1688,34571095,Effect of centrally and peripherally acting GABA B  agonism on the healthy human cough reflex.,"BACKGROUND


Currently there are no effective licensed anti-tussive therapies. Understanding how the neuronal mechanisms mediating the cough reflex in animal models translate to humans is important for the development of effective therapies. Pre-clinical studies suggest that the activation of GABA B  receptors in both the peripheral and central nervous systems inhibit cough.
OBJECTIVE


To compare the effect of central and peripherally acting GABA B  agonists (lesogaberan and baclofen) on the cough reflex in healthy volunteers.
METHODS


We performed a single center, double-blind, double-dummy, three-way crossover trial in healthy controls comparing single doses of lesogaberan (120 mg MR), with baclofen (40 mg) and placebos. Cough responses to inhaled capsaicin were assessed at screening and 2h post-dose on each study day. The primary endpoint was the maximum number of coughs evoked at any concentration of capsaicin (Emax) and the secondary endpoint was the concentration evoking 50% of the maximal response (ED50).
RESULTS


Fifteen participants enrolled onto the study (median age 29 (IQR 25-44) years; 7 females, mean BMI 24.6(±3.0). Lesogaberan treatment produced a small, statistically significant increase in Emax compared with placebo [mean 13.4coughs (95%CI 10.1-17.9) vs. 11.8coughs (8.8-15.9), p = 0.04], but had no effect on ED50 [geometric mean 47.4 μM (95%CI 24.4-91.7) vs 37.6 μM (95%CI 19.2-73.5), p = 0.37]. In contrast, baclofen had no significant effect on Emax (11.1, 95%CI 8.1-15.4) (p = 0.23), but significantly increased ED50 compared with placebo (geometric mean 75.2 μM (95%CI 37.2-151.8), p = 0.002).
CONCLUSION


This data suggests the anti-tussive actions of GABA B  agonists, in healthy volunteers, occur in the central rather than the peripheral nervous system.",2021,"Lesogaberan treatment produced a small, statistically significant increase in Emax compared with placebo [mean 13.4coughs (95%CI 10.1-17.9) vs. 11.8coughs (8.8-15.9), p=0.04], but had no effect on ED50 [geometric mean 47.4μM (95%CI 24.4-91.7) vs 37.6 μM (95%CI 19.2-73.5), p=0.37].","['Fifteen participants enrolled onto the study (median age 29 (IQR 25-44) years; 7 females, mean BMI 24.6(±3.0', 'healthy volunteers', 'healthy controls', 'healthy human cough reflex']","['lesogaberan (120mg MR), with baclofen (40mg) and placebos', 'central and peripherally acting GABA B  agonists (lesogaberan and baclofen', 'inhaled capsaicin', 'placebo', 'centrally and peripherally acting GABA B  agonism']","['Cough responses', 'maximum number of coughs evoked at any concentration of capsaicin (Emax', 'ED50', 'Emax', 'concentration evoking 50% of the maximal response (ED50']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0232051', 'cui_str': 'Cough reflex'}]","[{'cui': 'C2743108', 'cui_str': 'lesogaberan'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",15.0,0.287004,"Lesogaberan treatment produced a small, statistically significant increase in Emax compared with placebo [mean 13.4coughs (95%CI 10.1-17.9) vs. 11.8coughs (8.8-15.9), p=0.04], but had no effect on ED50 [geometric mean 47.4μM (95%CI 24.4-91.7) vs 37.6 μM (95%CI 19.2-73.5), p=0.37].","[{'ForeName': 'Huda', 'Initials': 'H', 'LastName': 'Badri', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Manchester Academic Health Sciences Centre, Manchester, UK; North Manchester General Hospital, Pennie Acute NHS Trust, UK, Department of Respiratory Medicine. Electronic address: huda.badri@manchester.ac.uk.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'LGibbard', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Manchester Academic Health Sciences Centre, Manchester, UK.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Denton', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Manchester Academic Health Sciences Centre, Manchester, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Satia', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Manchester Academic Health Sciences Centre, Manchester, UK; Division of Respiratory Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Dockry', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Manchester Academic Health Sciences Centre, Manchester, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Manchester Academic Health Sciences Centre, Manchester, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Escott', 'Affiliation': 'Emerging Innovations Unit, Scientific Partnering and Alliances, IMED Biotech Unit, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Greame', 'Initials': 'G', 'LastName': 'Wilkinson', 'Affiliation': 'Former Employees at AstraZeneca, Alderley Park, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Holt', 'Affiliation': 'Former Employees at AstraZeneca, Alderley Park, UK.'}, {'ForeName': 'Brendan J', 'Initials': 'BJ', 'LastName': 'Canning', 'Affiliation': 'Johns Hopkins Asthma and Allergy Ctr., Baltimore, MD, USA.'}, {'ForeName': 'Jacky A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Manchester Academic Health Sciences Centre, Manchester, UK.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2021.102079']
1689,34571090,Quality assurance program and early toxicities in the phase III BONBIS randomized trial evaluating the role of a localized radiation boost in ductal carcinoma in situ.,"PURPOSE


To describe the quality assurance (QA) program and early toxicities in the phase III randomized trial BONBIS (NCT00907868) on the role of a localized radiation boost in ductal carcinoma in situ (DCIS).
MATERIALS AND METHODS


From November 2008 to July 2014, 2004 patients were randomized in arm A (only whole breast radiotherapy, WBRT) and arm B (WBRT + boost). The QA program involved 44 participant centers that performed the dummy run (DR). Compliance and uniformity of clinical target volume (CTV) delineations, and dose prescription and delivery according to the BONBIS trial radiotherapy guidelines were analyzed. Acute toxicities (during and up to 3 months after radiotherapy completion, NCI-CTCAE v3.0 classification) were evaluated in 1929 patients.
RESULTS


The differences in whole breast CTV (CTV1) and planning target volume (PTV1) were ≤10%, and the differences in boost CTV (CTV2) and PTV (PTV2) were ≥20% compared with the reference DR values; 95% of the prescribed dose encompassed 98.7% and 100% of the median CTV1 and CTV2. Grade ≥2 breast erythema (38.3% vs. 22.4% of grade 2 and 5.4% vs. 2.1% of grade 3, p < 0.001), grade ≥2 dermatitis (2.8% vs. 0.7%, p < 0.001), and grade 2 hyperpigmentation (6.9% vs. 3.6%, p = 0.005) were more frequent in arm B than arm A. No acute lung or cardiac toxicity was observed. Smoking history, large breast size, and large breast CTV were strong predictive factors of grade ≥2 acute skin toxicities.
CONCLUSIONS


The QA program showed deviations in breast and tumor bed delineation. The boost significantly increased acute skin toxicities.",2021,"Grade ≥2 breast erythema (38.3% vs. 22.4% of grade 2 and 5.4% vs. 2.1% of grade 3, p<0.001), grade ≥2 dermatitis (2.8% vs. 0.7%, p<0.001), and grade 2 hyperpigmentation (6.9% vs. 3.6%, p=0.005) were more frequent in arm B than arm A. No acute lung or cardiac toxicity was observed.","['ductal carcinoma in situ', 'ductal carcinoma in situ (DCIS', '1929 patients', 'From November 2008 to July 2014, 2004 patients']","['whole breast radiotherapy, WBRT) and arm B (WBRT+boost']","['acute lung or cardiac toxicity', 'acute skin toxicities', 'Acute toxicities', 'quality assurance (QA) program and early toxicities', 'grade ≥2 dermatitis', 'Quality assurance program and early toxicities', 'whole breast CTV (CTV1) and planning target volume (PTV1', 'Grade ≥2 breast erythema', 'boost CTV (CTV2) and PTV (PTV2', 'Compliance and uniformity of clinical target volume (CTV) delineations', 'grade 2 hyperpigmentation']","[{'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0454198', 'cui_str': 'Clinical target volume'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}, {'cui': 'C0238819', 'cui_str': 'Red breast'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439827', 'cui_str': 'Uniformities'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}]",1929.0,0.0336901,"Grade ≥2 breast erythema (38.3% vs. 22.4% of grade 2 and 5.4% vs. 2.1% of grade 3, p<0.001), grade ≥2 dermatitis (2.8% vs. 0.7%, p<0.001), and grade 2 hyperpigmentation (6.9% vs. 3.6%, p=0.005) were more frequent in arm B than arm A. No acute lung or cardiac toxicity was observed.","[{'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Bourgier', 'Affiliation': ""Univ Montpellier, Montpellier, France; Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Montpellier, France; Fédération Universitaire d'Oncologie Radiothérapie d'Occitanie Méditerranée, Institut régional du Cancer Montpellier (ICM), Montpellier, France.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Cowen', 'Affiliation': 'Aix Marseille Univ, APHM, Hôpital Timone-Hôpital Nord, Département de Radiothérapie, Marseille, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Castan', 'Affiliation': 'Unité de Biométrie, Institut régional du Cancer Montpellier (ICM), Montpellier, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Lemanski', 'Affiliation': ""Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Montpellier, France; Fédération Universitaire d'Oncologie Radiothérapie d'Occitanie Méditerranée, Institut régional du Cancer Montpellier (ICM), Montpellier, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gourgou', 'Affiliation': 'Unité de Biométrie, Institut régional du Cancer Montpellier (ICM), Montpellier, France.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Rivera', 'Affiliation': ""Gustave Roussy, Département d'oncologie radiothérapie, Villejuif, France; Université Paris-Saclay, Inserm, U1030, Villejuif, France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Labib', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Peignaux', 'Affiliation': ""Département d'Oncologie Radiothérapie Centre Georges-François LECLERC, Dijon, France.""}, {'ForeName': 'Magali Le', 'Initials': 'ML', 'LastName': 'Blanc-Onfroy', 'Affiliation': 'Service de Radiothérapie, ICO René Gauducheau, Saint-Herblain, France.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Benyoucef', 'Affiliation': 'Département de Radiothérapie et de Physique médicale, Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Mege', 'Affiliation': 'Sainte Catherine, Institut du Cancer Avignon-Provence, Avignon, France.'}, {'ForeName': 'Zineb', 'Initials': 'Z', 'LastName': 'Douadi-Gaci', 'Affiliation': 'Hôpital privé Le Confluent, Nantes, France.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Racadot', 'Affiliation': 'Service de Radiothérapie, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Latorzeff', 'Affiliation': 'Département de radiothérapie-oncologie, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schick', 'Affiliation': 'Department of Radiation Oncology, University Hospital of Brest, UBO, LaTIM UMR 1101, Brest, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Jacquot', 'Affiliation': 'Centre de Cancerologie du Grand Montpellier, Montpellier, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Massabeau', 'Affiliation': 'Département de Radiotherapie, Institut Claudius Regaud IUCT-O, Toulouse, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Guilbert', 'Affiliation': 'Département de Radiothérapie, Institut Godinot, Reims, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Geffrelot', 'Affiliation': 'Service de Radiothérapie, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Ellis', 'Affiliation': ""Service de Radiothérapie, Centre Catalan d'Oncologie, Perpignan, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Lecouillard', 'Affiliation': 'Département de Radiothérapie, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Breton-Callu', 'Affiliation': 'Pôle oncologie, centre hospitalier Brive, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Richard-Tallet', 'Affiliation': ""Institut Paoli-Calmettes, département d'Oncologie Radiothérapie, Marseille, France; Centre de Recherche en Cancérologie de Marseille (CRCM), INSERM UMR 1068, Marseille, France.""}, {'ForeName': 'Fatiha', 'Initials': 'F', 'LastName': 'Boulbair', 'Affiliation': ""Service d'Oncologie-Radiothérapie, CHRU Besançon, France.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Cretin', 'Affiliation': 'Centre Médical ONCOGARD - ICG, Nîmes, France.'}, {'ForeName': 'Yazid', 'Initials': 'Y', 'LastName': 'Belkacémi', 'Affiliation': 'Department of Radiation Oncology and Henri Mondor Breast Center, AP HP - Henri Mondor University Hospital, University of Paris-Est (UPEC), INSERM Unit 955, Team 21-IMRB, Creteil, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Bons', 'Affiliation': ""Fédération Universitaire d'Oncologie Radiothérapie d'Occitanie Méditerranée, Institut régional du Cancer Montpellier (ICM), Montpellier, France; Service de Radiothérapie, CHU Nîmes, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Azria', 'Affiliation': ""Univ Montpellier, Montpellier, France; Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Montpellier, France; Fédération Universitaire d'Oncologie Radiothérapie d'Occitanie Méditerranée, Institut régional du Cancer Montpellier (ICM), Montpellier, France.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Fenoglietto', 'Affiliation': ""Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Montpellier, France; Fédération Universitaire d'Oncologie Radiothérapie d'Occitanie Méditerranée, Institut régional du Cancer Montpellier (ICM), Montpellier, France.""}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.09.014']
1690,34546187,An Analysis of the Impact of Timing and Technique on Outcomes after Surgery for Distal Radius Fractures: The Wrist and Radius Injury Surgical Trial Collaborative Study.,"BACKGROUND


Surgical treatment of closed distal radius fractures varies based on treatment, surgeon schedule, and patient preferences. The authors examined how timing and technique impact surgeon-perceived procedural difficulty and quality of reduction, outcomes, and complications.
METHODS


This was a retrospective study of participants in the randomized, multicenter Wrist and Radius Injury Surgical Trial with isolated unstable distal radius fractures. Participants were randomized to treatment with a volar locking plate system, closed reduction and percutaneous pinning, or external fixation. The authors analyzed surgeon-perceived procedural difficulty and reduction quality based on time to operation.
RESULTS


Of 184 participants, 88 underwent surgery less than 7 days after fracture (mean, 4.6 days) and 96 underwent surgery at more than 7 days after fracture (mean, 12.3 days). Surgery performed at more than 7 days was rated more difficult versus surgery at less than 7 days [4.6 versus 3.8 of 10 (1 = easiest); p = 0.05]. When the volar locking plate technique was performed, there was no difference in surgeon-perceived difficulty or reduction quality between the groups; however, surgeons performing closed reduction and percutaneous pinning more than 7 days after injury reported greater procedure difficulty (4.1 versus 2.9; p = 0.05) and poorer reduction quality compared to less than 7 days (7.2 versus 8.1; p = 0.03). Participants who underwent surgery at less than 7 days scored 8 and 7 points greater on the Michigan Hand Outcomes Questionnaire Satisfaction (p = 0.05) and Activities of Daily Living (p = 0.03) domains, respectively.
CONCLUSIONS


Surgery performed less than 7 days after fracture leads to better surgeon-perceived reduction quality and less procedural difficulty. If surgery cannot be performed before 7 days, the authors recommend patients undergo treatment with the volar locking plate system, given the comparable level of surgeon-perceived procedural difficulty and reduction quality when surgery was performed less than 7 days after injury.
CLINICAL QUERSTION/LEVEL OF EVIDENCE


Therapeutic, III.",2021,"When the volar locking plate technique was performed, there was no difference in surgeon-perceived difficulty or reduction quality between the groups; however, surgeons performing closed reduction and percutaneous pinning more than 7 days after injury reported greater procedure difficulty (4.1 versus 2.9; p = 0.05) and poorer reduction quality compared to less than 7 days (7.2 versus 8.1; p = 0.03).","['Of 184 participants, 88 underwent surgery less than 7 days after fracture (mean, 4.6 days) and 96 underwent surgery at more than 7 days after fracture (mean, 12.3 days', 'participants in the randomized, multicenter Wrist and Radius Injury Surgical Trial with isolated unstable distal radius fractures', 'Distal Radius Fractures']","['volar locking plate system, closed reduction and percutaneous pinning, or external fixation']","['procedure difficulty', 'poorer reduction quality', 'Activities of Daily Living', 'Michigan Hand Outcomes Questionnaire Satisfaction', 'surgeon-perceived difficulty or reduction quality']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",184.0,0.11651,"When the volar locking plate technique was performed, there was no difference in surgeon-perceived difficulty or reduction quality between the groups; however, surgeons performing closed reduction and percutaneous pinning more than 7 days after injury reported greater procedure difficulty (4.1 versus 2.9; p = 0.05) and poorer reduction quality compared to less than 7 days (7.2 versus 8.1; p = 0.03).","[{'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Hooper', 'Affiliation': 'From the Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School; and Department of Biostatistics, University of Michigan.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'From the Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School; and Department of Biostatistics, University of Michigan.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'From the Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School; and Department of Biostatistics, University of Michigan.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Shauver', 'Affiliation': 'From the Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School; and Department of Biostatistics, University of Michigan.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Chung', 'Affiliation': 'From the Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School; and Department of Biostatistics, University of Michigan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000008416']
1691,34544265,Statin Use and Lower Urinary Tract Symptoms Incidence and Progression in Reduction by Dutasteride of Prostate Cancer Events (REDUCE) Trial.,"PURPOSE


Benign prostatic hyperplasia (BPH) is a common disease often manifested by lower urinary tract symptoms (LUTS). We previously found statins were associated with modest attenuations in prostate growth over time in REDUCE. We tested whether statins were associated with LUTS incidence in asymptomatic men and LUTS progression in symptomatic men.
MATERIALS AND METHODS


We performed a post-hoc analysis of REDUCE in 3,060 ""asymptomatic"" men with baseline International Prostate Symptom Score (IPSS) <8 and in 2,198 symptomatic men with baseline IPSS ≥8 not taking α-blockers or 5α-reductase inhibitors. We used multivariable Cox regression models to assess associations between statin use at baseline and LUTS incidence and progression. Among asymptomatic men, incident LUTS was defined as the first reported medical or surgical treatment for BPH or sustained clinically significant LUTS (2 reports of IPSS >14). Among symptomatic men, LUTS progression was defined as IPSS increase ≥4 points from baseline, any surgical procedure for BPH, or initiation of a BPH drug.
RESULTS


Among asymptomatic and symptomatic men, 550 (18%) and 392 (18%) used statins at baseline, respectively. On multivariable analysis, statin use was not associated with LUTS incidence (HR 1.05; 95% CI 0.78-1.41, p=0.74) in asymptomatic men, or with LUTS progression (HR 1.13; 95% CI 0.96-1.33, p=0.15) in symptomatic men. Similar results were seen in the dutasteride and placebo arms when stratified by treatment assignment.
CONCLUSIONS


In REDUCE, statin use was not associated with either incident LUTS in asymptomatic men or LUTS progression in symptomatic men. These data do not support a role for statins in LUTS prevention or management.",2021,"In REDUCE, statin use was not associated with either incident LUTS in asymptomatic men or LUTS progression in symptomatic men.","['2198 symptomatic men with baseline IPSS ≥8', 'Benign prostatic hyperplasia (BPH', '3060 ""asymptomatic"" men with baseline International Prostate Symptom Score (IPSS']",['dutasteride and placebo'],"['LUTS incidence', 'Statin Use and Lower Urinary Tract Symptoms (LUTS) Incidence and Progression']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]","[{'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",3060.0,0.300389,"In REDUCE, statin use was not associated with either incident LUTS in asymptomatic men or LUTS progression in symptomatic men.","[{'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Kramer', 'Affiliation': 'Cedars-Sinai Medical Center.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Cedars-Sinai Medical Center.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Moreira', 'Affiliation': 'The University of Illinois College of Medicine.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Andriole', 'Affiliation': 'Washington University School of Medicine in St Louis.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Csizmadi', 'Affiliation': 'Cedars-Sinai Medical Center.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Cedars-Sinai Medical Center.'}]",The Journal of urology,['10.1097/JU.0000000000002199']
1692,34543939,Promoting resilience and lower stress in nurses and improving inpatient experience through emotional intelligence training in China: A randomized controlled trial.,"BACKGROUND


Emotional intelligence training relieves stress and promotes resilience among nurses. Previous studies have not sufficiently explored the effect of emotional intelligence training among nurses on the experience of inpatients under their care.
OBJECTIVE


To explore the effects of emotional intelligence training on emotional intelligence, resilience, and perceived stress among nurses and examine how training affects inpatient experience.
DESIGN


Randomized controlled trial.
SETTING


A tertiary general hospital in Changsha, China.
PARTICIPANTS


A total of 103 nurses were randomly selected from 20 wards.
METHODS


The wards were randomized into two groups. The intervention group (n = 53 nurses) received emotional intelligence training in two phases: Phase I-system training phase, twice a week for one month; Phase II-a consolidated learning phase, once a week for 11 months. The control group (n = 50) received daily briefings in meetings between head nurses, which were held regularly to discuss specific problems. There was no emotional intelligence training conducted with the control group. Data were collected at baseline and after the intervention.
RESULTS


Emotional intelligence training improved emotional intelligence, resilience, and stress in the intervention group. The control group scored lower on the Wong and Law's Emotional Intelligence Scale and all subscales, showed stability in the scores on the Connor-Davidson Resilience Scale and its subscales, and very little change in stress scores. Repeated measures analysis of variance showed significantly greater beneficial changes in the intervention group on all but the optimism subscale. There were suggestive differences in the predicted direction between the emotional intelligence training wards and the control wards at post-test on the patient experience scale and the four subscales.
CONCLUSION


Our study suggests that emotional intelligence training improves emotional intelligence, resilience, and stress among nurses and leads to improvements in inpatient experience. Emotional intelligence training should be part of nurse education to improve the quality of care nurses provide and their ability to work without increased stress.",2021,"The control group scored lower on the Wong and Law's Emotional Intelligence Scale and all subscales, showed stability in the scores on the Connor-Davidson Resilience Scale and its subscales, and very little change in stress scores.","['China', 'A total of 103 nurses were randomly selected from 20 wards', 'A tertiary general hospital in Changsha, China']","['emotional intelligence training', 'Emotional intelligence training']","['stress scores', 'optimism subscale', 'emotional intelligence, resilience, and perceived stress', ""Wong and Law's Emotional Intelligence Scale and all subscales, showed stability in the scores on the Connor-Davidson Resilience Scale and its subscales"", 'emotional intelligence, resilience, and stress']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0023150', 'cui_str': 'Law'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",103.0,0.0430049,"The control group scored lower on the Wong and Law's Emotional Intelligence Scale and all subscales, showed stability in the scores on the Connor-Davidson Resilience Scale and its subscales, and very little change in stress scores.","[{'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'Department of Nursing, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, China. Electronic address: maolian@csu.edu.cn.'}, {'ForeName': 'LingZhi', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Clinical Nursing Teaching and Research Section, The Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, China. Electronic address: huanglingzhi@csu.edu.cn.'}, {'ForeName': 'QiongNi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Clinical Nursing Teaching and Research Section, The Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, China. Electronic address: chenqiongni@csu.edu.cn.'}]",Nurse education today,['10.1016/j.nedt.2021.105130']
1693,34549535,Patterns of weight change in a weight gain prevention study for young adults.,"OBJECTIVE


Recovery from weight regain is uncommon during weight loss treatment. This study examined whether participants in a weight gain prevention intervention similarly struggle to recover following weight gains and which factors predict transitions.
METHODS


This is a secondary analysis of data from the Study of Novel Approaches to Weight Gain Prevention (SNAP), a randomized controlled trial comparing two weight gain prevention interventions with a control group. Young adults (n = 599; age 18-35 years) were followed over 3 years. Markov models identified transition rates in going above and returning below baseline weight across follow-up. Logistic regressions identified predictors of transitions.
RESULTS


At each time point, approximately double the number of participants who transitioned from below to above baseline transitioned from above to below. The magnitude of weight changes from baseline and the number of weight loss strategies used predicted transitions from below to above and above to below baseline weight (with opposite relationships). Infrequent self-weighing and lower dietary restraint predicted transitions below to above baseline weight. Treatment arm, demographics, calorie consumption, and physical activity generally did not predict transitions.
CONCLUSIONS


Young adults engaging in weight gain prevention struggle to lose gained weight. Alternative strategies are needed to address weight gains in weight gain prevention interventions.",2021,"Treatment arm, demographics, calorie consumption, and physical activity generally did not predict transitions.
","['Young adults (n = 599; age 18-35 years', 'young adults']","['Weight Gain Prevention (SNAP', 'weight gain prevention intervention', 'weight gain prevention interventions']","['demographics, calorie consumption, and physical activity generally did not predict transitions']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]",599.0,0.195246,"Treatment arm, demographics, calorie consumption, and physical activity generally did not predict transitions.
","[{'ForeName': 'Jacqueline F', 'Initials': 'JF', 'LastName': 'Hayes', 'Affiliation': 'Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gorin', 'Affiliation': 'Department of Psychological Sciences, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': 'Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Bahnson', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23268']
1694,34555676,"Tailored axillary surgery in patients with clinically node-positive breast cancer: Pre-planned feasibility substudy of TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101).","AIM


We developed tailored axillary surgery (TAS) to reduce the axillary tumor volume in patients with clinically node-positive breast cancer to the point where radiotherapy can control it. The aim of this study was to quantify the extent of tumor load reduction achieved by TAS.
METHODS


International multicenter prospective study embedded in a randomized trial. TAS is a novel pragmatic concept for axillary surgery de-escalation that combines palpation-guided removal of suspicious nodes with the sentinel procedure and, optionally, imaging-guided localization. Pre-specified study endpoints quantified surgical extent and reduction of tumor load.
RESULTS


A total of 296 patients were included at 28 sites in four European countries, 125 (42.2%) of whom underwent neoadjuvant chemotherapy (NACT) and 71 (24.0%) achieved nodal pathologic complete response. Axillary metastases were detectable only by imaging in 145 (49.0%) patients. They were palpable in 151 (51.0%) patients, of whom 63 underwent NACT and 21 had residual palpable disease after NACT. TAS removed the biopsied and clipped node in 279 (94.3%) patients. In 225 patients with nodal disease at the time of surgery, TAS removed a median of five (IQR 3-7) nodes, two (IQR 1-4) of which were positive. Of these 225 patients, 100 underwent ALND after TAS, which removed a median of 14 (IQR 10-17) additional nodes and revealed additional positive nodes in 70/100 (70%) of patients. False-negative rate of TAS in patients who underwent subsequent ALND was 2.6%.
CONCLUSIONS


TAS selectively reduced the tumor load in the axilla and remained much less radical than ALND.",2021,"TAS is a novel pragmatic concept for axillary surgery de-escalation that combines palpation-guided removal of suspicious nodes with the sentinel procedure and, optionally, imaging-guided localization.","['A total of 296 patients were included at 28 sites in four European countries, 125 (42.2%) of whom underwent', '225 patients with nodal disease', 'patients with clinically node-positive breast cancer']","['radiotherapy', 'TAXIS (OPBC-03', 'TAS', 'neoadjuvant chemotherapy (NACT', 'Tailored axillary surgery', 'NACT', 'tailored axillary surgery (TAS']","['False-negative rate of TAS', 'nodal pathologic complete response', 'Axillary metastases', 'residual palpable disease']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0185114', 'cui_str': 'Manual reduction'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0684830', 'cui_str': 'Secondary malignant neoplasm of axilla'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0522499', 'cui_str': 'Palpable'}]",296.0,0.0808957,"TAS is a novel pragmatic concept for axillary surgery de-escalation that combines palpation-guided removal of suspicious nodes with the sentinel procedure and, optionally, imaging-guided localization.","[{'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Weber', 'Affiliation': 'Breast Center, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: walter.weber@usb.ch.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Matrai', 'Affiliation': 'Department of Breast and Sarcoma Surgery, National Institute of Oncology, Budapest, Hungary; University of Szeged, H-6725 Szeged, Hungary.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hayoz', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Tausch', 'Affiliation': 'Breast Center Zurich, Zurich, Switzerland.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Henke', 'Affiliation': 'Department of Radiation Oncology, St. Gallen Cantonal Hospital, St. Gallen, Switzerland; Breast Center, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Zwahlen', 'Affiliation': 'Department of Radiation Oncology, Cantonal Hospital Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Institute of Radiotherapy, Klinik Hirslanden, Zurich, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zimmermann', 'Affiliation': 'University of Basel, Basel, Switzerland; Department of Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Seiler', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Maddox', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ruhstaller', 'Affiliation': 'Breast Center Eastern Switzerland, St. Gallen, Switzerland.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Muenst', 'Affiliation': 'University of Basel, Basel, Switzerland; Institute of Medical Genetics and Pathology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Ackerknecht', 'Affiliation': 'University of Basel, Basel, Switzerland; Department of Biomedicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kuemmel', 'Affiliation': 'Breast Unit, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Bjelic-Radisic', 'Affiliation': 'Breast Unit, Helios University Clinic, University Witten/Herdecke, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kurzeder', 'Affiliation': 'Breast Center, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mihály', 'Initials': 'M', 'LastName': 'Újhelyi', 'Affiliation': 'Department of Breast and Sarcoma Surgery, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Conny', 'Initials': 'C', 'LastName': 'Vrieling', 'Affiliation': 'Department of Radiation Oncology, Hirslanden Clinique des Grangettes, Geneva, Switzerland.'}, {'ForeName': 'Rok', 'Initials': 'R', 'LastName': 'Satler', 'Affiliation': 'Breast Center, Cantonal Hospital Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'Breast Center, Cantonal Hospital Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Becciolini', 'Affiliation': 'Breast Center, Réseau Hospitalier Neuchâtelois, La Chaux-de-Fonds, Switzerland.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Bucher', 'Affiliation': 'Breast Center, Cantonal Hospital Lucerne, Lucerne, Switzerland.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Simonson', 'Affiliation': 'Department of Gynecology, Centre Hospitalier du Haut-Valais (SZO), Sion, Switzerland.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Fehr', 'Affiliation': 'Breast Center Graubünden, Cantonal Hospital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gabriel', 'Affiliation': 'Breast Center, City Hospital Triemli, Zurich, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Maráz', 'Affiliation': 'Department of Oncology, Bacs-Kiskun Country Hospital, Kecskemet, Hungary.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Sarlos', 'Affiliation': 'Breast Center, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Konstantin J', 'Initials': 'KJ', 'LastName': 'Dedes', 'Affiliation': 'Breast Cancer Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Leo', 'Affiliation': 'Breast Center, Cantonal Hospital Baden, Baden, Switzerland.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Berclaz', 'Affiliation': 'Breast Center Bern, Lindenhof Group, Bern, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dubsky', 'Affiliation': 'Breast Center, Hirslanden Klinik St. Anna, Lucerne, Switzerland; Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Exner', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Fansa', 'Affiliation': 'Breast Center Zürich, Bethanien & Spital Zollikerberg, Zurich, Switzerland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hager', 'Affiliation': 'Department of Gynecology and Obstetrics, City Hospital, Dornbirn, Austria.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Reisenberger', 'Affiliation': 'Department of Gynecology and Obstetrics, Klinikum Wels-Grieskirchen, Wels, Austria.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of Gynecology and Obstetrics and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Reitsamer', 'Affiliation': 'Breast Center, Paracelsus Medical University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Mattea', 'Initials': 'M', 'LastName': 'Reinisch', 'Affiliation': 'Breast Unit, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Winkler', 'Affiliation': 'Breast Center, Basel Bethesda Hospital, Basel, Switzerland.'}, {'ForeName': 'Giang Thanh', 'Initials': 'GT', 'LastName': 'Lam', 'Affiliation': 'Breast Center, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Mathias K', 'Initials': 'MK', 'LastName': 'Fehr', 'Affiliation': 'Breast Center Thurgau, Münsterlingen, Switzerland.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Naydina', 'Affiliation': 'Spital Limmattal, Schlieren, Switzerland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Kohlik', 'Affiliation': 'Breast Center, Clinique de Genolier, Genolier, Switzerland.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Clerc', 'Affiliation': 'Brustzentrum Freiburg, Centre du sein Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Valerijus', 'Initials': 'V', 'LastName': 'Ostapenko', 'Affiliation': 'National Cancer Institute, Vilnius, Lithuania.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Fitzal', 'Affiliation': 'Department of Surgery and Breast Health Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Nussbaumer', 'Affiliation': 'Breast Center, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Maggi', 'Affiliation': 'Breast Center, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'University of Basel, Basel, Switzerland; Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Pagona', 'Initials': 'P', 'LastName': 'Markellou', 'Affiliation': 'Breast Center, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Lelièvre', 'Affiliation': 'Breast Center, CHUV, Lausanne, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Breast Cancer Center Tirol, Department of Gynecology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': 'Breast Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Knauer', 'Affiliation': 'Breast Center Eastern Switzerland, St. Gallen, Switzerland.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2021.09.004']
1695,34554693,Efficacy of Single-shot Thoracic Paravertebral Block Combined with Intravenous Analgesia Versus Continuous Thoracic Epidural Analgesia for Chronic Pain After Thoracotomy.,"BACKGROUND


Patients undergoing thoracic surgery frequently suffer from chronic pain after thoracotomy. Chronic pain can lead to a significant decline in a patient's quality of life. However, the effect of single-shot thoracic paravertebral block (TPVB) combined with intravenous analgesia on chronic pain incidence is unclear.
OBJECTIVE


The objective was to evaluate the impact of single-shot TPVB combined with intravenous analgesia versus continuous thoracic epidural analgesia (TEA) on chronic pain incidence after thoracotomy.
STUDY DESIGN


A randomized controlled study.
SETTING


Hospital department in China.
METHODS


Ninety-six patients undergoing thoracotomy were randomly assigned to 2 groups: single-shot TPVB combined with intravenous analgesia (Group P) and continuous TEA (Group E). The pain intensity was assessed using the Verbal Rating Scale (VRS). The outcome measures were chronic pain incidence and the acute and chronic pain intensity.
RESULTS


The chronic pain incidence at rest in Group P was significantly higher than that in Group E at 3 months and 12 months postoperation  (55.2% versus 28.6%, P = 0.019; 34.5% versus 14.3%, P = 0.027). The patients in Group E showed less pain intensity at rest compared with those in Group P at 3 months postoperation (0.0 versus 1.0, P = 0.034). At 6 hours and 24 hours postoperation, the acute pain intensity at coughing and at rest in Group E was lower than that in group P (VRS at coughing: 6 hours: 0.0 versus 2.0, P = 0.001; 24 hours: 3.0 versus 5.0, P = 0.010. VRS at rest: 6 hours: 0.0 versus 2.0, P = 0.000; 24 hours: 1.0versus. 2.0, P = 0.001).
LIMITATIONS


An important limitation of this study is that it is not a double-blind study.
CONCLUSIONS


In patients undergoing thoracotomy, continuous TEA significantly reduced the chronic pain incidence at rest at 3 months and 12 months after operation and provided better acute pain relief up to 24 hours after operation compared with single-shot TPVB combined with intravenous analgesia.",2021,"The chronic pain incidence at rest in Group P was significantly higher than that in Group E at 3 months and 12 months postoperation  (55.2% versus 28.6%, P = 0.019; 34.5% versus 14.3%, P = 0.027).","['Patients undergoing thoracic surgery frequently suffer from chronic pain after thoracotomy', 'Hospital department in China', 'Ninety-six patients undergoing thoracotomy']","['TPVB combined with intravenous analgesia versus continuous thoracic epidural analgesia (TEA', 'single-shot TPVB combined with intravenous analgesia (Group P) and continuous TEA', 'single-shot thoracic paravertebral block (TPVB) combined with intravenous analgesia', 'Single-shot Thoracic Paravertebral Block Combined with Intravenous Analgesia Versus Continuous Thoracic Epidural Analgesia', 'thoracotomy, continuous TEA']","['chronic pain incidence and the acute and chronic pain intensity', 'Chronic pain', 'acute pain relief', 'Chronic Pain', 'pain intensity', 'Verbal Rating Scale (VRS', 'chronic pain incidence', 'acute pain intensity at coughing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0019961', 'cui_str': 'Hospital department'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1959948', 'cui_str': 'Continuous thoracic epidural analgesia'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}]",96.0,0.285699,"The chronic pain incidence at rest in Group P was significantly higher than that in Group E at 3 months and 12 months postoperation  (55.2% versus 28.6%, P = 0.019; 34.5% versus 14.3%, P = 0.027).","[{'ForeName': 'Xiu-Liang', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wan', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'The Pain Department, Zao Zhuang Municipal Hospital, Zaozhuang, Shandong Province, China.'}]",Pain physician,[]
1696,34554692,The Antioxidant Effect of Selenium on Succinylcholine-related Myalgia After Adult Sinuscopies: Randomized Controlled Double-Blind Trial.,"BACKGROUND


Succinylcholine has a fast onset, short duration of action, and is considered the choice for rapid sequence intubation. However, it produces muscle stiffness and postoperative myalgia (POM) as adverse effects. We hypothesized that the antioxidant selenium might affect POM incidence and severity.
OBJECTIVES


The study aimed to investigate the antioxidant effect of selenium (against free radicals' release) in minimizing the frequency of succinylcholine-related POM, measured by the 4-point myalgia score. The severity of fasciculations and the postoperative analgesic profile were recorded. The correlation between fasciculations and POM was also observed.
STUDY DESIGN


A prospective randomized controlled double-blind clinical study.
SETTING


Assiut University Hospitals.
METHODS


The current study included 80 adult patients scheduled for sinuscopies and randomly assigned into 2 equal groups. Two hours before the induction of general anesthesia, patients in the control group received oral placebo tablets, while patients in the selenium group received oral selenium 200 µg. The primary outcome of this trial was the POM score at 24 hours. Secondary outcomes included the intensity of fasciculations, Numeric Rating Scale (NRS), rescue analgesic consumption, and adverse effects of the studied drugs.
RESULTS


Myalgia scores were significantly decreased after selenium administration throughout the follow-up period (P = 0.023). No significant difference was reported regarding the incidence or degree of fasciculations (P = 0.511). A mild correlation was noticed between fasciculations and POM with r = 0.176 and P < 0.061. The NRS values were significant between groups at 6 hours after the procedure. There were significant differences (P < 0.05) regarding postoperative supplement analgesia, time to the first rescue analgesia, and the mean total number of analgesic claims. Significant differences were recorded for potassium levels only 30 minutes and creatine kinase levels at 6 and 24 hours postoperatively.
LIMITATIONS


This study was applied on a single surgical category and other types of surgical procedures may have an effect on outcomes. Additional larger sample size studies and various doses of selenium may help to validate our results. Selenium is quite a significant element of the enzymatic antioxidant process through glutathione peroxidase. We did not measure the glutathione peroxidase level in blood.
CONCLUSIONS


Oral selenium effectively reduced the succinylcholine-induced postoperative myalgia. It prolonged the time to first required analgesia and decreased the analgesic consumption throughout the whole study period without affecting the hemodynamics or any serious adverse effects.",2021,It prolonged the time to first required analgesia and decreased the analgesic consumption throughout the whole study period without affecting the hemodynamics or any serious adverse effects.,"['80 adult patients scheduled for sinuscopies and randomly assigned into 2 equal groups', 'related Myalgia After Adult Sinuscopies', 'Assiut University Hospitals']","['Selenium', 'selenium group received oral selenium 200 µg', 'antioxidant selenium', 'selenium', 'Succinylcholine', 'oral placebo tablets']","['Myalgia scores', 'POM incidence and severity', 'muscle stiffness and postoperative myalgia (POM', 'intensity of fasciculations, Numeric Rating Scale (NRS), rescue analgesic consumption, and adverse effects of the studied drugs', 'glutathione peroxidase level', 'severity of fasciculations and the postoperative analgesic profile', 'incidence or degree of fasciculations', 'postoperative supplement analgesia, time to the first rescue analgesia, and the mean total number of analgesic claims', 'POM score', 'potassium levels only 30 minutes and creatine kinase levels', 'fasciculations and POM', 'analgesic consumption', 'succinylcholine-induced postoperative myalgia', 'NRS values']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038627', 'cui_str': 'Succinylcholine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015644', 'cui_str': 'Muscle fasciculation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0750863', 'cui_str': 'Finding of creatine kinase level'}, {'cui': 'C0038627', 'cui_str': 'Succinylcholine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",80.0,0.243082,It prolonged the time to first required analgesia and decreased the analgesic consumption throughout the whole study period without affecting the hemodynamics or any serious adverse effects.,"[{'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Assiut University, Assiut , Egypt.'}, {'ForeName': 'Ekram A', 'Initials': 'EA', 'LastName': 'Osman', 'Affiliation': 'Department of Anesthesia and Intensive Care, Assiut University, Egypt.'}, {'ForeName': 'Mahmoud M Abo', 'Initials': 'MMA', 'LastName': 'Elkasem', 'Affiliation': 'Department of Anesthesia and Intensive Care, Assiut University, Egypt.'}, {'ForeName': 'Mohamed Ismail', 'Initials': 'MI', 'LastName': 'Seddik', 'Affiliation': 'Department of Clinical Pathology, Assiut University, Egypt.'}, {'ForeName': 'Ragaa', 'Initials': 'R', 'LastName': 'Herdan', 'Affiliation': 'Department of Anesthesia and Intensive Care, Assiut University, Assiut , Egypt.'}]",Pain physician,[]
1697,34554691,A Randomized Controlled Trial of High Rate rTMS Versus rTMS and Amitriptyline in Chronic Migraine.,"BACKGROUND


The patients with chronic migraine (CM) respond poorly to pharmacological agents including tricyclic antidepressants, beta-blockers, anticonvulsants, calcium channel blockers, flunarizine, and melatonin. The combination of 2 or more pharmacological agents has not shown better efficacy but increased side effects. High rate repetitive transcranial magnetic stimulation (rTMS) has been reported effective in episodic migraine and converts CM to episodic migraine. A combination of high rate rTMS with a pharmacological agent may be more effective compared to rTMS alone.
OBJECTIVES


We evaluate the efficacy and safety of 10 Hz rTMS compared to rTMS and amitriptyline in CM.
STUDY DESIGN


Randomized controlled trial.
SETTING


Tertiary care teaching institute in India.
METHODS


Patients with CM as per International Classification of Headache Disorder third edition (ICHD-3) beta criteria were included whose age was between 18 years and 55 years. CM was defined if there were 15 headache days per month and at least 8 of these attacks having migraine characteristics for a period of more than 3 months. Patients with major psychiatric, other neurological or systemic disease, and those on migraine prophylaxis were excluded. The demographic details, frequency of headache attacks and headache days per month, migraine triggers, and associated symptoms were noted. The severity of headache was noted using a 0-10 Visual Analog Scale and the number of abortive drugs per month was noted. CM patients were randomly assigned to rTMS (group I) or rTMS and amitriptyline (group II). 10 Hz rTMS was applied using a figure of eight magnetic stimulation coil. The coil was placed over the left frontal cortex corresponding to the hot spot of the right abductor digiti minimi, which is approximately 7 cm lateral from the midline and 2 cm anterior to interaural line. The motor threshold was measured, and 70% of it was used for rTMS. Ten trains of 10 Hz rTMS, each train comprising of 60 pulses with an inter-train interval of 45 seconds were delivered in one session. Three such sessions were delivered on an alternate day and were repeated every month for 3 months. Amitriptyline was prescribed in a dose of 10mg, increased to 25mg after 2 weeks; thereafter increase in dose to 50 mg was optional. The primary outcome was > 50% reduction in headache days, and secondary outcomes were the reduction in severity of headache, abortive drug, and side effects.
RESULTS


Forty-one patients were included in group I and 42 in group II, and their baseline characteristics were comparable. A higher proportion of group II patients had more than 50% reduction in headache days at 3 months (76.2 vs 31.7%; P < 0.001) compared to group I. More than 50% reduction in headache severity was also greater in group II compared to group I at 3 months (47.6% vs 19.5%; P = 0.01). Side effects were comparable, and none had to be withdrawn.
LIMITATIONS


A higher proportion of patients was shifted from group I to group II.
CONCLUSION


Combination of rTMS and amitriptyline is safe and more effective in CM compared to rTMS alone.",2021,A higher proportion of group II patients had more than 50% reduction in headache days at 3 months (76.2 vs 31.7%; P < 0.001) compared to group I. More than 50% reduction in headache severity was also greater in group II compared to group,"['patients with chronic migraine (CM', 'Chronic Migraine', 'Patients with CM as per International Classification of Headache Disorder third edition (ICHD-3) beta criteria were included whose age was between 18 years and 55 years', 'CM patients', 'Patients with major psychiatric, other neurological or systemic disease, and those on migraine prophylaxis were excluded', '10', 'Tertiary care teaching institute in India', 'Forty-one patients were included in group']","['High Rate rTMS Versus rTMS and Amitriptyline', 'rTMS and amitriptyline', 'flunarizine, and melatonin', 'High rate repetitive transcranial magnetic stimulation (rTMS', '10 Hz rTMS', 'rTMS', 'Hz rTMS', 'Amitriptyline']","['demographic details, frequency of headache attacks and headache days per month, migraine triggers, and associated symptoms', 'severity of headache, abortive drug, and side effects', 'headache severity', 'severity of headache', 'headache days', 'efficacy and safety', 'Side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0393735', 'cui_str': 'Headache disorder'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C1142085', 'cui_str': 'Migraine prophylaxis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0002600', 'cui_str': 'Amitriptyline'}, {'cui': 'C0016295', 'cui_str': 'Flunarizine'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0857361', 'cui_str': 'Headache occurring'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",41.0,0.0185566,A higher proportion of group II patients had more than 50% reduction in headache days at 3 months (76.2 vs 31.7%; P < 0.001) compared to group I. More than 50% reduction in headache severity was also greater in group II compared to group,"[{'ForeName': 'Jayantee', 'Initials': 'J', 'LastName': 'Kalita', 'Affiliation': 'Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow 226014, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh India.'}, {'ForeName': 'Varun K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh India.'}, {'ForeName': 'Usha K', 'Initials': 'UK', 'LastName': 'Misra', 'Affiliation': 'Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow 226014, India.'}]",Pain physician,[]
1698,34554690,Investigation of Effectiveness of Two Different Kinesiotaping Techniques in Myofascial Pain Syndrome: An Open-Label Randomized Clinical Trial.,"BACKGROUND


Myofascial pain syndrome is a regional musculoskeletal pain syndrome characterized by trigger points. Although there are widely accepted treatment modalities, there is no gold standard treatment. Kinesiotaping represents an interesting modality in the treatment of musculoskeletal disorders and attracts attention with studies emerging in the recent years, but in spite of the proposed benefits of kinesiotaping, its efficacy is still unclear, thus further studies evaluating the effectiveness of kinesiotaping are needed.
OBJECTIVES


We aimed to investigate, not only the effectiveness of kinesiotaping applied with the space correction and muscle inhibition techniques (compared to the home exercise program in reducing pain and improving functional status and quality of life in female patients with myofascial pain syndrome related to active trigger points in the upper trapezius), but also to evaluate the superiority of the 2 techniques over each other.
STUDY DESIGN


An open-label randomized clinical trial with a parallel assignment intervention model.
SETTING


The physical medicine and rehabilitation clinics in Istanbul University, Istanbul Faculty of Medicine.
METHODS


Seventy-one female patients with the complaint of pain in the upper trapezius region, diagnosed with myofascial pain syndrome, and having at least one active trigger point in the upper trapezius fibers, were randomly assigned by a computer program to 1 of the 3 groups: kinesiotaping with the space correction technique (KSCT, n = 20), kinesiotaping with the muscle inhibition technique (KMIT, n = 24), and the home exercise program alone (control group [CG], n = 27). The patients were evaluated by the numerical rating scale for pain intensity, the neck disability index for functional status, and the 36-Item Short-Form Health Survey for quality of life in the beginning of the study and at the first, second, and sixth weeks (1-month follow-up).
RESULTS


Kinesiotaping was associated with lower pain intensity levels (P = 0.019 at the first week and P = 0.026 at the second week) and better functional status (P = 0.011 at the second week) and it was effective in increasing quality of life by improving physical functions and general health (P = 0.033 and P = 0.003 at the second week, respectively) earlier than in the CG. Role limitations due to physical factors improved in the KMIT group earlier than in the other groups (P = 0.022 at the second week).
LIMITATIONS


Being performed in a limited number of female patients only, absence of a placebo group, and lack of blinded assessments.
CONCLUSION


Both kinesiotaping methods were associated with lower pain intensity levels and better functional status and were effective in increasing quality of life by improving physical functions and general health earlier than the home exercise program. There was no significant difference between the kinesiotaping methods, except for role limitations due to the physical factors domain of SF-36 which was improved in the KMIT group earlier than in the KSCT group and CGs.",2021,Both kinesiotaping methods were associated with lower pain intensity levels and better functional status and were effective in increasing quality of life by improving physical functions and general health earlier than the home exercise program.,"['The physical medicine and rehabilitation clinics in Istanbul University, Istanbul Faculty of Medicine', 'Seventy-one female patients with the complaint of pain in the upper trapezius region, diagnosed with myofascial pain syndrome, and having at least one active trigger point in the upper trapezius fibers', 'Myofascial Pain Syndrome', 'female patients with myofascial pain syndrome']","['Two Different Kinesiotaping Techniques', 'kinesiotaping with the space correction technique (KSCT, n = 20), kinesiotaping with the muscle inhibition technique (KMIT, n = 24), and the home exercise program alone (control group [CG', 'KSCT', 'placebo', 'kinesiotaping applied with the space correction and muscle inhibition techniques (compared to the home exercise program', 'KMIT']","['numerical rating scale for pain intensity, the neck disability index for functional status, and the 36-Item Short-Form Health Survey for quality of life', 'physical factors domain of SF-36', 'quality of life by improving physical functions and general health earlier', 'quality of life by improving physical functions and general health', 'functional status', 'pain and improving functional status and quality of life', 'pain intensity levels']","[{'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",71.0,0.022757,Both kinesiotaping methods were associated with lower pain intensity levels and better functional status and were effective in increasing quality of life by improving physical functions and general health earlier than the home exercise program.,"[{'ForeName': 'Fatma Merih', 'Initials': 'FM', 'LastName': 'Akpinar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Baltalimani Metin Sabanci Bone Diseases Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Dilsad', 'Initials': 'D', 'LastName': 'Sindel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Aysegül', 'Initials': 'A', 'LastName': 'Ketenci', 'Affiliation': 'Istanbul Faculty of Medicine, Istanbul University, Fatih, Turkey.'}]",Pain physician,[]
1699,34537494,"Efficacy of single-photon emission computed tomography aided botulinum toxin injection in cervical dystonia: A double-blind, randomized study.","BACKGROUND


Although single-photon emission computed tomography (SPECT/CT) could help to predetermine dystonic muscles in patients with cervical dystonia (CD), its efficacy in aiding botulinum toxin injection is undetermined. This randomized, double-blinded study aimed to assess the efficacy of SPECT/CT aided botulinum toxin injection in CD.
METHODS


Patients were randomized into study group (candidate muscles selected by SPECT/CT and clinical evaluation) or control group (clinical evaluation). Follow-ups were done at two weeks (T1), one (T2), three (T3) and six months (T4). The primary outcomes included symptom improvement assessed using Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and Tsui score at T2.
RESULTS


A total of 122 patients were enrolled and 108 patients accomplished the study. For primary outcomes, the study group had significantly better symptom improvement at T2 (TWSTRS: β, -4.86 [95%CI -9.40 to -0.32; P = 0.036]; Tsui: β, -1.65 [95%CI -2.77 to -0.54; P = 0.004]). For secondary outcomes, the study group also showed better outcomes at T1 (TWSTRS: β, -6.33 [95%CI -10.17 to -2.49; P = 0.001]; Tsui: β, -1.42 [95%CI -2.48 to -0.37; P = 0.008]) and T3 (TWSTRS: β, -6.05 [95%CI -11.09 to -1.01; P = 0.019]; Tsui: β, -1.24 [95%CI -2.40 to -0.08; P = 0.037]). The interval of re-injection was significantly longer in the study group than the control group (159.1 ± 28.6 versus 141.8 ± 51.0 days, P = 0.032).
CONCLUSIONS


SPECT/CT could improve the efficacy of botulinum toxin in CD. It could become a useful tool to aid botulinum toxin injection.",2021,"The interval of re-injection was significantly longer in the study group than the control group (159.1 ± 28.6 versus 141.8 ± 51.0 days, P = 0.032).
","['122 patients were enrolled and 108 patients accomplished the study', 'patients with cervical dystonia (CD', 'Patients were randomized into study group (candidate muscles selected by', 'cervical dystonia']","['single-photon emission computed tomography aided botulinum toxin injection', 'SPECT/CT aided botulinum toxin injection', 'single-photon emission computed tomography (SPECT/CT', 'SPECT/CT', 'SPECT/CT and clinical evaluation) or control group (clinical evaluation']","['symptom improvement', 'interval of re-injection', 'symptom improvement assessed using Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and Tsui score at T2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C3472245', 'cui_str': 'Single photon emission computed tomography with computed tomography'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",122.0,0.564763,"The interval of re-injection was significantly longer in the study group than the control group (159.1 ± 28.6 versus 141.8 ± 51.0 days, P = 0.032).
","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Teng', 'Affiliation': 'Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Issa', 'Initials': 'I', 'LastName': 'Malam Djibo', 'Affiliation': 'Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Nuclear Medicine, Shanghai Tongji Hospital, Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Junhui', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Yougui', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Lizhen', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Lingjing', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200065, China; Department of Neurorehabilitation, Yangzhi Rehabilitation Hospital, Tongji University School of Medicine, 2209 Guangxing Road, Shanghai, 201619, China. Electronic address: lingjingjin@163.com.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2021.09.002']
1700,34558312,Thromboprophylaxis for Children Post-Fontan Procedure: Insights From the UNIVERSE Study.,"Background Patients with single-ventricle physiology who undergo the Fontan procedure are at risk for thrombotic events associated with significant morbidity and mortality. The UNIVERSE Study evaluated the efficacy and safety of a novel liquid rivaroxaban formulation, using a body weight-adjusted dosing regimen, versus acetylsalicylic acid (ASA) in children post-Fontan. Methods and Results The UNIVERSE Study was a randomized, multicenter, 2-part, open-label study of rivaroxaban, in children who had undergone a Fontan procedure, to evaluate its dosing regimen, safety, and efficacy. Part A was the single-arm part of the study that determined the pharmacokinetics/pharmacodynamics and safety of rivaroxaban in 12 participants before proceeding to part B, whereby 100 participants were randomized 2:1 to open-label rivaroxaban versus ASA. The study period was 12 months. A total of 112 participants were enrolled across 35 sites in 10 countries. In part B, for safety outcomes, major bleeding occurred in one participant on rivaroxaban (epistaxis that required transfusion). Clinically relevant nonmajor bleeding occurred in 6% of participants on rivaroxaban versus 9% on ASA. Trivial bleeding occurred in 33% of participants on rivaroxaban versus 35% on ASA. For efficacy outcomes, 1 participant on rivaroxaban in part B had a pulmonary embolism (2% overall event rate); and for ASA, 1 participant had ischemic stroke and 2 had venous thrombosis (9% overall event rate). Conclusions In this study, participants who received rivaroxaban for thromboprophylaxis had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the ASA group. Registration URL: https://www.clinicaltrials.gov. Identifier: NCT02846532.",2021,"In this study, participants who received rivaroxaban for thromboprophylaxis had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the ASA group.","['children who had undergone a Fontan procedure, to evaluate its dosing regimen, safety, and efficacy', '12 participants before proceeding to part B, whereby 100 participants', 'Children Post-Fontan Procedure', '112 participants were enrolled across 35 sites in 10 countries', 'children post-Fontan']","['open-label rivaroxaban versus ASA', 'Thromboprophylaxis', 'rivaroxaban', 'novel liquid rivaroxaban formulation', 'acetylsalicylic acid (ASA']","['morbidity and mortality', 'thrombotic events', 'nonmajor bleeding', 'safety outcomes, major bleeding', 'Trivial bleeding', 'pulmonary embolism', 'efficacy and safety', 'ischemic stroke and 2 had venous thrombosis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0190010', 'cui_str': 'Fontan procedure'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}]",112.0,0.14935,"In this study, participants who received rivaroxaban for thromboprophylaxis had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the ASA group.","[{'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'The Hospital for Sick Children University of Toronto Toronto ON Canada.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Michelson', 'Affiliation': ""Boston Children's HospitalHarvard Medical School Boston MA.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Van Bergen', 'Affiliation': ""Advocate Children's Hospital Oak Lawn IL.""}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Suzana Horowitz', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology Porto Alegre Brazil.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pablo Sandoval', 'Affiliation': 'National Institute of Cardiology Mexico City Mexico.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Justino', 'Affiliation': ""Rady Children's Hospital San Diego CA.""}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Harris', 'Affiliation': ""Children's Heart CentreBC Children's Hospital Vancouver BC Canada.""}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Jefferies', 'Affiliation': 'The Cardiac Institute University of Tennessee Health Science Center Memphis TN.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Miriam Pina', 'Affiliation': 'Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Peluso', 'Affiliation': 'Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Nessel', 'Affiliation': 'Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Duke University Medical Center Durham NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.120.021765']
1701,34556856,Valsartan in early-stage hypertrophic cardiomyopathy: a randomized phase 2 trial.,"Hypertrophic cardiomyopathy (HCM) is often caused by pathogenic variants in sarcomeric genes and characterized by left ventricular (LV) hypertrophy, myocardial fibrosis and increased risk of heart failure and arrhythmias. There are no existing therapies to modify disease progression. In this study, we conducted a multi-center, double-blind, placebo-controlled phase 2 clinical trial to assess the safety and efficacy of the angiotensin II receptor blocker valsartan in attenuating disease evolution in early HCM. In total, 178 participants with early-stage sarcomeric HCM were randomized (1:1) to receive valsartan (320 mg daily in adults; 80-160 mg daily in children) or placebo for 2 years ( NCT01912534 ). Standardized changes from baseline to year 2 in LV wall thickness, mass and volumes; left atrial volume; tissue Doppler diastolic and systolic velocities; and serum levels of high-sensitivity troponin T and N-terminal pro-B-type natriuretic protein were integrated into a single composite z-score as the primary outcome. Valsartan (n = 88) improved cardiac structure and function compared to placebo (n = 90), as reflected by an increase in the composite z-score (between-group difference +0.231, 95% confidence interval (+0.098, +0.364); P = 0.001), which met the primary endpoint of the study. Treatment was well-tolerated. These results indicate a key opportunity to attenuate disease progression in early-stage sarcomeric HCM with an accessible and safe medication.",2021,Treatment was well-tolerated.,"['early HCM', '178 participants with early-stage sarcomeric HCM', 'early-stage hypertrophic cardiomyopathy']","['angiotensin II receptor blocker valsartan', 'placebo', 'Valsartan', 'valsartan']","['safety and efficacy', 'composite z-score', 'LV wall thickness, mass and volumes; left atrial volume; tissue Doppler diastolic and systolic velocities; and serum levels of high-sensitivity troponin T and N-terminal pro-B-type natriuretic protein', 'cardiac structure and function', 'tolerated']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1292769', 'cui_str': 'Precursor B-cell lymphoblastic leukemia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",178.0,0.463187,Treatment was well-tolerated.,"[{'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. cho@bwh.harvard.edu.""}, {'ForeName': 'Sharlene M', 'Initials': 'SM', 'LastName': 'Day', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Axelsson', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Russell', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Zahka', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Harry M', 'Initials': 'HM', 'LastName': 'Lever', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Pereira', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Colan', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Margossian', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murphy', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Canter', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Bach', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wheeler', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Rossano', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Anjali T', 'Initials': 'AT', 'LastName': 'Owens', 'Affiliation': 'Division of Cardiovascular Medicine Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Benson', 'Affiliation': 'Toronto Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Mestroni', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Matthew R G', 'Initials': 'MRG', 'LastName': 'Taylor', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Amit R', 'Initials': 'AR', 'LastName': 'Patel', 'Affiliation': 'Departments of Medicine and Radiology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Wilmot', 'Affiliation': ""Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Thrush', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Vargas', 'Affiliation': 'MedStar Heart and Vascular Institute, Washington, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Soslow', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Becker', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Seidman', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Neal K', 'Initials': 'NK', 'LastName': 'Lakdawala', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Cirino', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Burns', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Calum A', 'Initials': 'CA', 'LastName': 'MacRae', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Nature medicine,['10.1038/s41591-021-01505-4']
1702,34559851,"Examining the impact of a community-based exercise intervention on cardiorespiratory fitness, cardiovascular health, strength, flexibility and physical activity among adults living with HIV: A three-phased intervention study.","PURPOSE


Our aim was to examine the impact of a community-based exercise (CBE) intervention on cardiorespiratory fitness, cardiovascular health, strength, flexibility, and physical activity outcomes among adults living with HIV.
METHODS


We conducted a longitudinal intervention study with community-dwelling adults living with HIV in Toronto, Canada. We measured cardiopulmonary fitness (V̇O2peak (primary outcome), heart rate, blood pressure), strength (grip strength, vertical jump, back extension, push-ups, curl ups), flexibility (sit and reach test), and self-reported physical activity bimonthly across three phases. Phase 1 included baseline monitoring (8 months); Phase 2 included the CBE Intervention (6 months): participants were asked to exercise (aerobic, strength, balance and flexibility training) for 90 minutes, 3 times/week, with weekly supervised coaching at a community-based fitness centre; and Phase 3 included follow-up (8 months) where participants were expected to continue with thrice weekly exercise independently. We used segmented regression (adjusted for baseline age and sex) to assess the change in trend (slope) among phases. Our main estimates of effect were the estimated change in slope, relative to baseline values, over the 6 month CBE intervention.
RESULTS


Of the 108 participants who initiated Phase 1, 80 (74%) started and 67/80 (84%) completed the intervention and 52/67 (77%) completed the study. Most participants were males (87%), with median age of 51 years (interquartile range (IQR): 45, 59). Participants reported a median of 4 concurrent health conditions in addition to HIV (IQR: 2,7). Participants attended a median of 18/25 (72%) weekly supervised sessions. Change in V̇O2peak attributed to the six-month Phase 2 CBE intervention was 0.56 ml/kg/min (95% Confidence Interval (CI): -1.27, 2.39). Significant effects of the intervention were observed for systolic blood pressure (-5.18 mmHg; 95% CI: -9.66, -0.71), push-ups (2.30 additional push-ups; 95% CI: 0.69, 3.91), curl ups (2.89 additional curl ups; 95% CI: 0.61, 5.17), and sit and reach test (1.74 cm; 95% CI: 0.21, 3.28). More participants engaged in self-reported strength (p<0.001) and flexibility (p = 0.02) physical activity at the end of intervention. During Phase 3 follow-up, there was a significant reduction in trend of benefits observed during the intervention phase for systolic blood pressure (1.52 mmHg/month; 95% CI: 0.67, 2.37) and sit and reach test (-0.42 cm/month; 95% CI: -0.68, -0.16).
CONCLUSION


Adults living with HIV who engaged in this six-month CBE intervention demonstrated inconclusive results in relation to V̇O2peak, and potential improvements in other outcomes of cardiovascular health, strength, flexibility and self-reported physical activity. Future research should consider features tailored to promote uptake and sustained engagement in independent exercise among adults living with HIV.
CLINICALTRIALS.GOV IDENTIFIER


NCT02794415. https://clinicaltrials.gov/ct2/show/record/NCT02794415.",2021,More participants engaged in self-reported strength (p<0.001) and flexibility (p = 0.02) physical activity at the end of intervention.,"['Adults living with HIV', '108 participants who initiated Phase 1, 80 (74%) started and 67/80 (84%) completed the intervention and 52/67 (77%) completed the study', 'community-dwelling adults living with HIV in Toronto, Canada', 'Most participants were males (87%), with median age of 51 years (interquartile range (IQR', 'adults living with HIV']","['exercise (aerobic, strength, balance and flexibility training', 'community-based exercise (CBE) intervention', 'community-based exercise intervention', 'supervised coaching at a community-based fitness centre']","['cardiopulmonary fitness (V̇O2peak (primary outcome), heart rate, blood pressure), strength (grip strength, vertical jump, back extension, push-ups, curl ups), flexibility (sit and reach test), and self-reported physical activity', 'strength (p<0.001) and flexibility', 'cardiorespiratory fitness, cardiovascular health, strength, flexibility, and physical activity outcomes', 'cardiovascular health, strength, flexibility and self-reported physical activity', 'cardiorespiratory fitness, cardiovascular health, strength, flexibility and physical activity', 'systolic blood pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",108.0,0.218147,More participants engaged in self-reported strength (p<0.001) and flexibility (p = 0.02) physical activity at the end of intervention.,"[{'ForeName': 'Kelly K', 'Initials': 'KK', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Physical Therapy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Aileen M', 'Initials': 'AM', 'LastName': 'Davis', 'Affiliation': 'Department of Physical Therapy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Chan Carusone', 'Affiliation': 'Casey House, Toronto, Ontario, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Avery', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Solomon', 'Affiliation': 'School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Aubry', 'Affiliation': 'Department of Physical Therapy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Zobeiry', 'Affiliation': 'Central Toronto YMCA, Toronto, Ontario, Canada.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Ilic', 'Affiliation': 'Central Toronto YMCA, Toronto, Ontario, Canada.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Pandovski', 'Affiliation': 'Central Toronto YMCA, Toronto, Ontario, Canada.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Bayoumi', 'Affiliation': 'Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, Ontario, Canada.'}]",PloS one,['10.1371/journal.pone.0257639']
1703,34579122,Assessment of Body Composition as an Indicator of Early Peripheral Parenteral Nutrition Therapy in Patients Undergoing Colorectal Cancer Surgery in an Enhanced Recovery Program.,"BACKGROUND


A poor body composition (BC) has been identified as a risk factor for patients with colorectal cancer (CRC). This study was performed to assess the effect of early peripheral parenteral nutrition (PPN) on BC in patients undergoing CCR surgery within an enhanced recovery program.
METHODS


Patients with normal nutritional status were prospectively included between October 2016 and September 2019, randomized into two groups (PPN with periOlimel N4-E versus conventional fluid therapy) and subsequently classified according to their preoperative CT scan into high- or low-risk BC groups. Postoperative complications and length of hospital stay (LOS) were assessed.
RESULTS


Of the 156 patients analyzed, 88 patients (56.4%) were classified as having high-risk BC according to CT measurements. PPN led to a 15.4% reduction in postoperative complications in high-risk vs. 1.7% in low-risk BC patients. In the multivariate analysis, high-risk BC was related to an OR (95% CI) of 2 ( p  = 0.044) of presenting complications and of 1.9 ( p  = 0.066) for major complications, and was associated with an increase in LOS of 3.6 days ( p  = 0.039).
CONCLUSIONS


The measurement of patients' BC can allow for the identification of target patients where PPN has been proven to be an effective tool to improve postoperative outcomes.",2021,PPN led to a 15.4% reduction in postoperative complications in high-risk vs. 1.7% in low-risk BC patients.,"['Patients Undergoing Colorectal Cancer Surgery in an Enhanced Recovery Program', 'Patients with normal nutritional status were prospectively included between October 2016 and September 2019', 'patients undergoing CCR surgery within an enhanced recovery program', 'patients with colorectal cancer (CRC', '156 patients analyzed, 88 patients (56.4%) were classified as having high-risk BC according to CT measurements']","['early peripheral parenteral nutrition (PPN', 'PPN', 'PPN with periOlimel N4-E versus conventional fluid therapy) and subsequently classified according to their preoperative CT scan into high- or low-risk BC groups']","['LOS', 'postoperative complications', 'Postoperative complications and length of hospital stay (LOS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1955905', 'cui_str': 'CCR Receptors'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1527386', 'cui_str': 'Peripheral line feeding'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0534204,PPN led to a 15.4% reduction in postoperative complications in high-risk vs. 1.7% in low-risk BC patients.,"[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'López-Rodríguez-Arias', 'Affiliation': 'Colorectal Unit, Department of General Surgery, Elche University Hospital, Miguel Hernandez University, 03202 Elche, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Sánchez-Guillén', 'Affiliation': 'Colorectal Unit, Department of General Surgery, Elche University Hospital, Miguel Hernandez University, 03202 Elche, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lillo-García', 'Affiliation': 'Colorectal Unit, Department of General Surgery, Elche University Hospital, Miguel Hernandez University, 03202 Elche, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Aranaz-Ostáriz', 'Affiliation': 'Colorectal Unit, Department of General Surgery, Elche University Hospital, Miguel Hernandez University, 03202 Elche, Spain.'}, {'ForeName': 'M José', 'Initials': 'MJ', 'LastName': 'Alcaide', 'Affiliation': 'Colorectal Unit, Department of General Surgery, Elche University Hospital, Miguel Hernandez University, 03202 Elche, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Soler-Silva', 'Affiliation': 'Colorectal Unit, Department of General Surgery, Elche University Hospital, Miguel Hernandez University, 03202 Elche, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Soriano-Irigaray', 'Affiliation': 'Department of Pharmacy, Elche University Hospital-FISABIO, 03202 Elche, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Barber', 'Affiliation': 'Center for Operations Research, Miguel Hernandez University, 03202 Elche, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arroyo', 'Affiliation': 'Colorectal Unit, Department of General Surgery, Elche University Hospital, Miguel Hernandez University, 03202 Elche, Spain.'}]",Nutrients,['10.3390/nu13093245']
1704,34578808,"Supplementation with a Natural Source of Amino Acids, Sil-Q1 (Silk Peptide), Enhances Natural Killer Cell Activity: A Redesigned Clinical Trial with a Reduced Supplementation Dose and Minimized Seasonal Effects in a Larger Population.","The aim of this study was to re-validate the changes in natural killer (NK) cell cytotoxicity and cytokines related to T cells after Sil-Q1 (SQ; silk peptide) supplementation in a larger pool of Korean adults with minimized daily dose of SQ and controlling seasonal influence compared to the previous study. A total of 130 subjects were randomly assigned (1:1) to consume either 7.5 g of SQ or placebo for 8 weeks. NK cell cytotoxicity and cytokines were measured at T0 (baseline) and T8 (follow-up). Comparing the NK cell cytotoxicity values at T0 and T8 within each group, the cytotoxicity at all effector cell (E) to target cell (T) ratios of 10:1, 5:1, 2.5:1, and 1.25:1 was significantly increased in the SQ group at T8. Additionally, significant differences in the changed value (Δ, subtract baseline values from follow-up values) comparison between the groups at E:T = 10:1, 5:1, and 2.5:1 were found. As a secondary endpoint, the interleukin (IL)-12 level in the SQ group was significantly increased for 8 weeks, and Δ IL-12 in the SQ group was greater than in the placebo group. In conclusion, the present study showed considerable practical implications of SQ supplementation. Thus, SQ is an effective and safe functional food supplement for enhancing immune function.",2021,"As a secondary endpoint, the interleukin (IL)-12 level in the SQ group was significantly increased for 8 weeks, and Δ IL-12 in the SQ group was greater than in the placebo group.","['A total of 130 subjects', 'Korean adults']","['Supplementation with a Natural Source of Amino Acids, Sil-Q1 (Silk Peptide', 'SQ or placebo', 'Sil-Q1 (SQ; silk peptide) supplementation', 'placebo']","['Natural Killer Cell Activity', 'NK cell cytotoxicity values', 'cytotoxicity at all effector cell (E) to target cell (T) ratios', 'NK cell cytotoxicity and cytokines', 'interleukin (IL)-12 level', 'natural killer (NK) cell cytotoxicity and cytokines related to T cells']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0074529', 'cui_str': 'Silk'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0312740', 'cui_str': 'Immune effector cell'}, {'cui': 'C0221284', 'cui_str': 'Leptocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",130.0,0.459522,"As a secondary endpoint, the interleukin (IL)-12 level in the SQ group was significantly increased for 8 weeks, and Δ IL-12 in the SQ group was greater than in the placebo group.","[{'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Cho', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Dokyeong', 'Initials': 'D', 'LastName': 'Yoo', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Jeong-Yong', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'WORLDWAY Co., Ltd., Sejong-si 30003, Korea.'}, {'ForeName': 'Mi-Sun', 'Initials': 'MS', 'LastName': 'Oh', 'Affiliation': 'WORLDWAY Co., Ltd., Sejong-si 30003, Korea.'}, {'ForeName': 'Ki-Chan', 'Initials': 'KC', 'LastName': 'Ha', 'Affiliation': 'Healthcare Claims & Management Inc., Jeonju 54810, Korea.'}, {'ForeName': 'Hyang-Im', 'Initials': 'HI', 'LastName': 'Baek', 'Affiliation': 'Healthcare Claims & Management Inc., Jeonju 54810, Korea.'}, {'ForeName': 'Seung-Min', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Brain Korea 21 PLUS Project, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Jong Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'Yoo', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul 03722, Korea.'}]",Nutrients,['10.3390/nu13092930']
1705,34556273,5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease.,"OBJECTIVES


The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).
BACKGROUND


Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset.
METHODS


Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m 2 ) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory-adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed.
RESULTS


The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR.
CONCLUSIONS


In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.",2021,"Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR.
","['Patients with severe AS and CKD undergoing TAVR or SAVR', 'patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing', 'Patients with and without perioperative acute kidney injury (AKI', 'Patients', '1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients', 'Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate\xa0<60\xa0mL/min/m 2 ) from the PARTNER (Placement of Aortic Transcatheter Valve']","['transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR', 'SAPIEN XT TAVR or SAVR', 'Surgical Versus Transcatheter Aortic Valve Replacement']","['death, stroke, rehospitalization, and new hemodialysis', 'Perioperative AKI', 'SAPIEN XT TAVR', 'bioprosthetic valve failure and stage 2 or 3 structural valve deterioration', '5-year cardiovascular, renal, and bioprosthetic valve durability outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C4285833', 'cui_str': 'Structural valve deterioration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1045.0,0.090157,"Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR.
","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Garcia', 'Affiliation': 'Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA; Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA. Electronic address: santiagogarcia@me.com.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Cubeddu', 'Affiliation': 'NCH Healthcare System, Naples, Florida, USA.'}, {'ForeName': 'Rebecca T', 'Initials': 'RT', 'LastName': 'Hahn', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York, USA; Division of Cardiology, Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Ternacle', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Samir R', 'Initials': 'SR', 'LastName': 'Kapadia', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Susheel K', 'Initials': 'SK', 'LastName': 'Kodali', 'Affiliation': 'Division of Cardiology, Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Department of Cardiovascular Surgery, Marcus Heart and Vascular Center, Piedmont Heart and Vascular Institute, Atlanta, Georgia, USA.'}, {'ForeName': 'Wael A', 'Initials': 'WA', 'LastName': 'Jaber', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Asher', 'Affiliation': 'Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic Weston, Weston, Florida, USA.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Elmariah', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Makkar', 'Affiliation': 'Cedars-Sinai Heart Institute, Los Angeles, California, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Webb', 'Affiliation': ""St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Herrmann', 'Affiliation': 'Department of Cardiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Edwards Lifesciences, Irvine, California, USA.'}, {'ForeName': 'Chandan M', 'Initials': 'CM', 'LastName': 'Devireddy', 'Affiliation': 'Department of Cardiology, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'S Chris', 'Initials': 'SC', 'LastName': 'Malaisrie', 'Affiliation': 'Department of Cardiac Surgery, Northwestern University Feinberg School of Medicine and Northwestern Memorial Hospital, Chicago, Illinois, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Smith', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York, USA; Division of Cardiology, Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Department of Cardiothoracic Surgery, Baylor Scott & White Health, Plano, Texas, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sorajja', 'Affiliation': 'Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA; Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA.'}, {'ForeName': 'João L', 'Initials': 'JL', 'LastName': 'Cavalcante', 'Affiliation': 'Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA; Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Goessl', 'Affiliation': 'Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA; Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Gautam R', 'Initials': 'GR', 'LastName': 'Shroff', 'Affiliation': 'Hennepin Healthcare and University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York, USA; Division of Cardiology, Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pibarot', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2021.07.004']
1706,34554715,"In Response to Comments on ""Long-term Efficacy of Percutaneous Epidural Neurolysis of Adhesions in Chronic Lumbar Radicular Pain: 10-Year Follow-Up of a Randomized Controlled Trial"".",,2021,,['Chronic Lumbar Radicular Pain'],['Percutaneous Epidural Neurolysis of Adhesions'],[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4552557', 'cui_str': 'Lumbar radicular pain'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0394927', 'cui_str': 'Epidural neurolysis'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}]",[],,0.18702,,"[{'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Gerdesmeyer', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, University Schleswig Holstein, Campus Kiel, Kiel, Germany; Department of Orthopedics and Sport orthopedics, Klinikum rechts der Isar, München, Germany.'}]",Pain physician,[]
1707,34554714,"Comments on ""Long-term Efficacy of Percutaneous Epidural Neurolysis of Adhesions in Chronic Lumbar Radicular Pain: 10-Year Follow-Up of a Randomized Controlled Trial"".",,2021,,['Chronic Lumbar Radicular Pain'],['Percutaneous Epidural Neurolysis of Adhesions'],[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4552557', 'cui_str': 'Lumbar radicular pain'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0394927', 'cui_str': 'Epidural neurolysis'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}]",[],,0.245688,,"[{'ForeName': 'Min Cheol', 'Initials': 'MC', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Yeungnam University, Korea.'}]",Pain physician,[]
1708,34554710,"Comments on ""Efficacy of Pulsed Radiofrequency or Short-Term Spinal Cord Stimulation for Acute/Subacute Zoster-Related Pain: A Randomized, Double-Blinded, Controlled Trial"".",,2021,,['Acute/Subacute Zoster-Related Pain'],['Pulsed Radiofrequency or Short-Term Spinal Cord Stimulation'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]",[],,0.753278,,"[{'ForeName': 'Xixia', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Pain Management, West China Hospital, Sichuan University, Chengdu, Sichuan Province, P. R. China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Department of Pain Management, West China Hospital, Sichuan University, Chengdu, Sichuan Province, P. R. China.'}]",Pain physician,[]
1709,34554694,"A Double-Blind, Placebo-Controlled Study of Ultrasound-Guided Pulsed Radiofrequency Treatment of the Saphenous Nerve for Refractory Osteoarthritis-Associated Knee Pain.","BACKGROUND


While the efficacy of pulsed radiofrequency (PRF) for shoulder pain has been demonstrated, its efficacy on the saphenous nerves for knee osteoarthritis (OA)-associated pain has only been reported in observational studies.
OBJECTIVES


The aim of this study was to compare saphenous nerve PRF to placebo for knee OA-associated pain.
STUDY DESIGN


Patients, practitioners, and outcome assessor-blinded randomized placebo-controlled trial.
SETTING


Pain management clinics at 2 hospitals in Japan.
METHODS


Patients were randomly allocated to the PRF (n = 37) or placebo group (n = 33). Patients aged 40-85 years with refractory anteromedial knee pain. PRF in the saphenous nerve under ultrasound guidance. The placebo group underwent the same procedure, but with motor stimulation. The primary endpoint was the average pain intensity measured using the visual analog scale (VAS) at the 12-week post-treatment visit; secondary outcomes included the average VAS at 1 and 4 weeks, and pain intensities at rest, in flexion, at standing, and at walking. Other secondary outcomes were knee pain, symptoms, activities of daily living, knee-related quality of life, mobility, range of motion, and adverse events.
RESULTS


In the PRF group, the mean VAS score was 52.41 ± 26.17 at 12 weeks, while in the sham group, the mean VAS score was 63.06 ± 27.12 (P < 0.05). There were no significant differences between the groups in any of the secondary outcomes.
LIMITATIONS


Patients with comorbidities were excluded from this study. The follow-up time was limited to 12 weeks.
CONCLUSIONS


Ultrasound-guided saphenous nerve PRF proved to be effective for at least 12 weeks in patients with knee OA and showed no adverse events.",2021,"There were no significant differences between the groups in any of the secondary outcomes.
","['Patients, practitioners, and outcome assessor-blinded randomized', 'Patients', 'Patients aged 40-85 years with refractory anteromedial knee pain', 'Pain management clinics at 2 hospitals in Japan', 'Patients with comorbidities']","['Ultrasound-Guided Pulsed Radiofrequency Treatment', 'Placebo', 'PRF', 'pulsed radiofrequency (PRF', 'placebo']","['average VAS at 1 and 4 weeks, and pain intensities at rest, in flexion, at standing, and at walking', 'knee pain, symptoms, activities of daily living, knee-related quality of life, mobility, range of motion, and adverse events', 'visual analog scale (VAS', 'mean VAS score', 'average pain intensity', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.323409,"There were no significant differences between the groups in any of the secondary outcomes.
","[{'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Uematsu', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Osako', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Saya', 'Initials': 'S', 'LastName': 'Hakata', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Daijiro', 'Initials': 'D', 'LastName': 'Kabata', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Shintani', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Kawazoe', 'Affiliation': 'Anshin Clinic, Kobe, Japan.'}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Mizuno', 'Affiliation': 'Anshin Clinic, Kobe, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Fujino', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}]",Pain physician,[]
1710,34547600,Isometric exercise during immobilization reduces the time to return to play after lateral ankle sprain.,"[Objectives] Immobilization reduces symptoms after lateral ankle sprain but may worsen the range of motion (ROM) of the ankle and delay return to play (RTP). We aimed to elucidate the correlation between ankle ROM and time to RTP following immobilization for lateral ankle sprain and investigated if isometric exercise during immobilization would increase ROM and shorten the time to RTP. [Participants and outcome measures] Eighty-two patients with acute lateral ankle sprain were treated by a short-leg cast with or without isometric exercise and electrical muscle stimulation (EMS); intervention group or control group, respectively. The correlation between ankle ROM at cast removal and time to RTP was analyzed. The total and side-to-side ankle ROM and the time to RTP were compared between the two groups. [Results] Side-to-side difference in total ankle ROM significantly correlated with time to RTP (r = 0.38, p = 0.02). The intervention reduced the side-to-side difference in total ROM (20° versus 31°, p = 0.01) and time to RTP (46 versus 65 days, p = 0.01) compared to the control group. [Conclusion] Increased deficiency in ankle ROM led to a longer time to RTP, and isometric exercise combined with EMS during immobilization increased the total ankle ROM and shortened the time to RTP.",2021,"The intervention reduced the side-to-side difference in total ROM (20° versus 31°, p = 0.01) and time to RTP (46 versus 65 days, p = 0.01) compared to the control group.",['Participants and outcome measures] Eighty-two patients with acute lateral ankle sprain'],"['short-leg cast with or without isometric exercise and electrical muscle stimulation (EMS); intervention group or control group', 'Isometric exercise during immobilization']","['time to RTP', 'range of motion (ROM) of the ankle and delay return to play (RTP', 'total and side-to-side ankle ROM and the time to RTP', 'side-to-side difference in total ROM', 'total ankle ROM']","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}]","[{'cui': 'C0426901', 'cui_str': 'Short leg'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}]",82.0,0.0427588,"The intervention reduced the side-to-side difference in total ROM (20° versus 31°, p = 0.01) and time to RTP (46 versus 65 days, p = 0.01) compared to the control group.","[{'ForeName': 'Yasunao', 'Initials': 'Y', 'LastName': 'Toyoshima', 'Affiliation': 'Health and Sports Association Nabeshima Orthopaedic Clinic, 4-23-2 Matsunami, Chuo-ku, Chiba, Chiba, 260-0044, Japan.'}, {'ForeName': 'Ryuichiro', 'Initials': 'R', 'LastName': 'Akagi', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan; Sportsmedics Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan. Electronic address: rakagi@chiba-u.jp.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Nabeshima', 'Affiliation': 'Health and Sports Association Nabeshima Orthopaedic Clinic, 4-23-2 Matsunami, Chuo-ku, Chiba, Chiba, 260-0044, Japan.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.09.002']
1711,34547013,Efficacy of Sphincter Control Training and medical device in the treatment of premature ejaculation: A multicenter randomized controlled clinical trial.,"A new line of treatment for premature ejaculation (PE) based on the use of masturbation aid device in combination with behavioral techniques has emerged in recent years. We report a multicenter randomized clinical trial with a parallel group design to determine the effectiveness of an electronic device called Myhixel I© in the treatment of PE. Forty patients who met the criteria for the diagnosis of lifelong PE, were assigned to two treatment groups completed the Sphincter control training (SCT) program in eight weeks. The only difference between groups was the use of the device. The main measure was the ""fold increase"" (FI) of the intravaginal ejaculatory latency time (IELT). The geometric means of IELT show, at the end of the treatment at week 8, a superiority of the device group. The mean FI 4.27 (SD 2.59) at the end of treatment for the device group was clearly higher than obtained in the previous clinical trial, in which a specific medical device was not used. No side effects were observed and it required little therapeutic input and no partner involvement. The SCT program in combination with the Myhixel I© is an effective treatment for PE.",2021,A new line of treatment for premature ejaculation (PE) based on the use of masturbation aid device in combination with behavioral techniques has emerged in recent years.,"['Forty patients who met the criteria for the diagnosis of lifelong PE', 'premature ejaculation', 'premature ejaculation (PE']","['Myhixel I', 'Sphincter Control Training and medical device', 'Sphincter control training (SCT) program', 'electronic device called Myhixel I©']","['fold increase"" (FI) of the intravaginal ejaculatory latency time (IELT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",40.0,0.0568127,A new line of treatment for premature ejaculation (PE) based on the use of masturbation aid device in combination with behavioral techniques has emerged in recent years.,"[{'ForeName': 'Jesús E', 'Initials': 'JE', 'LastName': 'Rodríguez', 'Affiliation': 'Research Area, Murcian Institute of Sexology, Murcia, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Picazo', 'Affiliation': 'Research Area, Murcian Institute of Sexology, Murcia, Spain.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Marzo', 'Affiliation': 'Department of Health Psychology, University Miguel Hernández of Elche, Elche, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Piqueras', 'Affiliation': 'Department of Health Psychology, University Miguel Hernández of Elche, Elche, Spain.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Reina', 'Affiliation': 'Urology Service, Rafael Méndez University Hospital, Lorca, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Hidalgo', 'Affiliation': 'Urology Service, Rafael Méndez University Hospital, Lorca, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Tornero', 'Affiliation': 'Faculty of Psychology, University of Murcia, Murcia, Spain.'}]",PloS one,['10.1371/journal.pone.0257284']
1712,34545117,Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe).,"Severe sepsis is a time critical condition which is known to have a high mortality rate. Evidence suggests that early diagnosis and early administration of antibiotics can reduce morbidity and mortality from sepsis. The prehospital phase of emergency medical care may provide the earliest opportunity for identification of sepsis and delivery of life-saving treatment for patients. We aimed to assess the feasibility of (1) paramedics recognising and screening patients for severe sepsis, collecting blood cultures and administering intravenous antibiotics; and (2) trial methods in order to decide whether a fully-powered trial should be undertaken to determine safety and effectiveness of this intervention. Paramedics were trained in using a sepsis screening tool, aseptic blood culture collection and administration of intravenous antibiotics. If sepsis was suspected, paramedics randomly allocated patients to intervention or usual care using scratchcards. Patients were followed up at 90 days using linked anonymised data to capture length of hospital admission and mortality. We collected self-reported health-related quality of life at 90 days. We pre-specified criteria for deciding whether to progress to a fully-powered trial based on: recruitment of paramedics and patients; delivery of the intervention; retrieval of outcome data; safety; acceptability; and success of anonymised follow-up. Seventy-four of the 104 (71.2%) eligible paramedics agreed to take part and 54 completed their training (51.9%). Of 159 eligible patients, 146 (92%) were recognised as eligible by study paramedics, and 118 were randomised (74% of eligible patients, or 81% of those recognised as eligible). Four patients subsequently dissented to be included in the trial (3%), leaving 114 patients recruited to follow-up. All recruited patients were matched to routine data outcomes in the Secure Anonymised Information Linkage Databank. Ninety of the 114 (79%) recruited patients had sepsis or a likely bacterial infection recorded in ED. There was no evidence of any difference between groups in patient satisfaction, and no adverse reactions reported. There were no statistically significant differences between intervention and control groups in Serious Adverse Events (ICU admissions; deaths). This feasibility study met its pre-determined progression criteria; an application will therefore be prepared and submitted for funding for a fully-powered multi-centre randomised trial.Trial registration: ISRCTN36856873 sought 16th May 2017; https://doi.org/10.1186/ISRCTN36856873.",2021,There were no statistically significant differences between intervention and control groups in Serious Adverse Events (ICU admissions; deaths).,"['emergency patients with sepsis (PhRASe', 'Seventy-four of the 104 (71.2%) eligible paramedics agreed to take part and 54 completed their training (51.9', 'Four patients subsequently dissented to be included in the trial (3%), leaving 114 patients recruited to follow-up', 'Ninety of the 114 (79%) recruited patients had sepsis or a likely bacterial infection recorded in ED', 'patients', '159 eligible patients, 146 (92%) were recognised as eligible by study paramedics, and 118 were randomised (74% of eligible patients, or 81% of those recognised as eligible']","['prehospital recognition and antibiotics', 'intervention or usual care using scratchcards', 'intravenous antibiotics']",['Serious Adverse Events (ICU admissions; deaths'],"[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0600665', 'cui_str': 'Phrase'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0012742', 'cui_str': 'Dissent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",159.0,0.0582044,There were no statistically significant differences between intervention and control groups in Serious Adverse Events (ICU admissions; deaths).,"[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Swansea University Medical School, ILS2, Singleton Campus, Wales, SA2 8PP, UK. j.k.jones@swansea.ac.uk.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Cardiff and Vale University Health Board, Wales, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Public Contributor, Wales, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Driscoll', 'Affiliation': 'Swansea University Medical School, ILS2, Singleton Campus, Wales, SA2 8PP, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Ellis', 'Affiliation': 'Cardiff and Vale University Health Board, Wales, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Fegan', 'Affiliation': 'Swansea University Medical School, ILS2, Singleton Campus, Wales, SA2 8PP, UK.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Foster', 'Affiliation': 'East of England Ambulance Service NHS Trust, Royston, England, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Francis', 'Affiliation': 'University of Southampton, Southampton, UK.'}, {'ForeName': 'Saiful', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'Swansea University Medical School, ILS2, Singleton Campus, Wales, SA2 8PP, UK.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': 'Cardiff and Vale University Health Board, Wales, UK.'}, {'ForeName': 'Prabath W B', 'Initials': 'PWB', 'LastName': 'Nanayakkara', 'Affiliation': 'Amsterdam University Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'University of Warwick, Warwick, England, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Porter', 'Affiliation': 'Swansea University Medical School, ILS2, Singleton Campus, Wales, SA2 8PP, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Rainer', 'Affiliation': 'Cardiff and Vale University Health Board, Wales, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Ricketts', 'Affiliation': 'Welsh Ambulance Services NHS Trust, Wales, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Sewell', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Wales, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Shanahan', 'Affiliation': 'Cardiff and Vale University Health Board, Wales, UK.'}, {'ForeName': 'Fang Gao', 'Initials': 'FG', 'LastName': 'Smith', 'Affiliation': 'University of Birmingham, Birmingham, England, UK.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Smyth', 'Affiliation': 'University of Warwick, Warwick, England, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Snooks', 'Affiliation': 'Swansea University Medical School, ILS2, Singleton Campus, Wales, SA2 8PP, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Welsh Ambulance Services NHS Trust, Wales, UK.'}]",Scientific reports,['10.1038/s41598-021-97979-w']
1713,34562773,Anticipating pride or regret? Effects of anticipated affect focused persuasive messages on intention to get vaccinated against COVID-19.,Understanding the factors that increase intention to receive COVID-19 vaccines is essential to maximise the vaccination campaign effectiveness. The present experimental study evaluated the effect of exposure to messages targeting cognitive attitude plus anticipated positive (pride) or negative (regret) affective reactions on intention to get vaccinated. Participants included 484 Italian adults randomly allocated to one of four conditions: 1) cognitive attitude message; 2) cognitive attitude plus positive affect message; 3) cognitive attitude plus negative affect message; 4) control condition (no message). Results showed that participants in the second condition reported greater intention to get vaccinated against COVID-19 compared with those in the control condition. Parallel mediation analysis indicated that the effect of the second condition on intention was fully mediated by cognitive attitude and anticipated positive affect. These findings suggest that future campaigns aimed at promoting COVID-19 vaccination intention could usefully target both cognitive attitude and anticipated positive affect.,2021,Parallel mediation analysis indicated that the effect of the second condition on intention was fully mediated by cognitive attitude and anticipated positive affect.,['Participants included 484 Italian adults randomly allocated to one of four conditions: 1'],"['cognitive attitude plus anticipated positive (pride) or negative (regret) affective reactions', 'cognitive attitude message; 2) cognitive attitude plus positive affect message; 3) cognitive attitude plus negative affect message; 4) control condition (no message']",['greater intention to get vaccinated against COVID-19'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",484.0,0.0444365,Parallel mediation analysis indicated that the effect of the second condition on intention was fully mediated by cognitive attitude and anticipated positive affect.,"[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Capasso', 'Affiliation': 'Department of Humanities, University of Naples Federico II, Italy. Electronic address: miriam.capasso@unina.it.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Caso', 'Affiliation': 'Department of Humanities, University of Naples Federico II, Italy.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conner', 'Affiliation': 'School of Psychology, University of Leeds, UK.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2021.114416']
1714,34562764,Grinding and polishing of the inner surface of monolithic simplified restorations made of zirconia polycrystals and lithium disilicate glass-ceramic: Effects on the load-bearing capacity under fatigue of the bonded restorations.,"This study evaluated the effect of grinding and polishing the inner surface of monolithic discs made of zirconia polycrystals (ZR) and lithium disilicate glass-ceramic (LD) on the load-bearing capacity under fatigue of the restorations bonded onto a dentin analogue material (epoxy resin). ZR and LD ceramic discs (10 mm in diameter, 1 mm in thickness) were produced and randomly allocated into 10 groups considering the internal adjustment approach: Ctrl - No adjustment; F - Grinding with fine diamond bur (46 μm); F + Pol - Grinding with fine diamond bur followed by polishing with 2 tips (finisher and polisher); FF - Grinding with extrafine diamond bur (30 μm); FF + Pol - Grinding with extrafine diamond bur followed by polishing. In addition, discs (10 mm in diameter, 2.5 mm in thickness) of fiber reinforced epoxy resin were produced. Afterwards, the intaglio surface of the ZR discs were air-abraded with 45 μm alumina particles for 10 s, the LD and resin epoxy discs were etched with hydrofluoric acid (5%/20 s and 10%/60 s, respectively), and the treated discs were primed as recommended. Each ceramic disc was luted onto the epoxy resin disc with resin cement. Then, the samples were tested under a step-stress fatigue test (20 Hz, 10,000 cycles/step, step-size of 100 N starting at 200 N, and proceeding until failure detection). Fractographic, topographic and surface roughness analysis were also performed. The adjustments (grinding with or without polishing) (ZR: 733-880 N; LD: 1040-1106 N) triggered a detrimental effect on the fatigue behavior in both ceramics compared with the absence of treatment (control group; ZR: 973 N; LD: 1406 N). The polishing step had no effect on fatigue findings. Thus, grinding the inner surface of the tested ceramics should be avoided wherever possible to prevent introducing damage and its detrimental effects on the fatigue behavior.",2021,The polishing step had no effect on fatigue findings.,[],"['hydrofluoric acid', 'zirconia polycrystals (ZR) and lithium disilicate glass-ceramic (LD', 'ZR and LD ceramic discs', 'lithium disilicate glass-ceramic', 'Ctrl - No adjustment; F - Grinding with fine diamond bur (46\xa0μm); F\xa0+\xa0Pol - Grinding with fine diamond bur followed by polishing with 2 tips (finisher and polisher); FF - Grinding with extrafine diamond bur (30\xa0μm); FF\xa0+\xa0Pol - Grinding with extrafine diamond bur followed by polishing']","['Fractographic, topographic and surface roughness analysis', 'fatigue behavior', 'fatigue findings']",[],"[{'cui': 'C0020274', 'cui_str': 'Hydrofluoric Acid'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",,0.121205,The polishing step had no effect on fatigue findings.,"[{'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Cadore-Rodrigues', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Sciences (Prosthodontic Units), Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: anacadorerodrigues@gmail.com.'}, {'ForeName': 'Renan Vaz', 'Initials': 'RV', 'LastName': 'Machry', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Sciences (Prosthodontic Units), Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: renanmachry@gmail.com.'}, {'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Sciences (Prosthodontic Units), Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Gabriel Kalil Rocha', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Sciences (Prosthodontic Units), Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Sciences (Prosthodontic Units), Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2021.104833']
1715,34555839,Intravenous Cetirizine vs Intravenous Diphenhydramine for the Prevention of Hypersensitivity Infusion Reactions: Results of an Exploratory Phase 2 Study.,"Pretreatment with antihistamines for the prevention of hypersensitivity infusion reactions is recommended for certain biologics and chemotherapies. Cetirizine is the first injectable second-generation antihistamine recently approved for acute urticaria. A randomized, exploratory phase 2 study evaluated intravenous (IV) cetirizine 10 mg versus IV diphenhydramine 50 mg as pretreatment in patients receiving an anti-CD20 agent or paclitaxel. In the overall population (N = 34) and an elderly subgroup (n = 21), IV cetirizine was as effective as IV diphenhydramine in preventing infusion reactions (primary outcome) and associated with less sedation at all time points, a shorter infusion center stay, and fewer treatment-related adverse events.",2021,Pretreatment with antihistamines for the prevention of hypersensitivity infusion reactions is recommended for certain biologics and chemotherapies.,"['patients receiving an', 'Hypersensitivity Infusion Reactions']","['Diphenhydramine', 'intravenous (IV) cetirizine', 'antihistamines', 'diphenhydramine', 'anti-CD20 agent or paclitaxel', 'cetirizine', 'Intravenous Cetirizine', 'Cetirizine']","['shorter infusion center stay, and fewer treatment-related adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction to drug or medicament administered by infusion'}]","[{'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.110783,Pretreatment with antihistamines for the prevention of hypersensitivity infusion reactions is recommended for certain biologics and chemotherapies.,"[{'ForeName': 'Jarrod P', 'Initials': 'JP', 'LastName': 'Holmes', 'Affiliation': 'St. Joseph Health Cancer Center, Santa Rosa, California (Dr Holmes); Oncology Consultants PA, Department of Research, Houston, Texas (Dr Peguero); Baylor Scott & White Medical Center, Temple, Texas (Dr Garland); and TerSera Therapeutics, Deerfield, Illinois (Ms North and Drs Young, Brent, and Joseph-Ridge).'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Peguero', 'Affiliation': 'St. Joseph Health Cancer Center, Santa Rosa, California (Dr Holmes); Oncology Consultants PA, Department of Research, Houston, Texas (Dr Peguero); Baylor Scott & White Medical Center, Temple, Texas (Dr Garland); and TerSera Therapeutics, Deerfield, Illinois (Ms North and Drs Young, Brent, and Joseph-Ridge).'}, {'ForeName': 'R Campbell', 'Initials': 'RC', 'LastName': 'Garland', 'Affiliation': 'St. Joseph Health Cancer Center, Santa Rosa, California (Dr Holmes); Oncology Consultants PA, Department of Research, Houston, Texas (Dr Peguero); Baylor Scott & White Medical Center, Temple, Texas (Dr Garland); and TerSera Therapeutics, Deerfield, Illinois (Ms North and Drs Young, Brent, and Joseph-Ridge).'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'North', 'Affiliation': 'St. Joseph Health Cancer Center, Santa Rosa, California (Dr Holmes); Oncology Consultants PA, Department of Research, Houston, Texas (Dr Peguero); Baylor Scott & White Medical Center, Temple, Texas (Dr Garland); and TerSera Therapeutics, Deerfield, Illinois (Ms North and Drs Young, Brent, and Joseph-Ridge).'}, {'ForeName': 'Stacia', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'St. Joseph Health Cancer Center, Santa Rosa, California (Dr Holmes); Oncology Consultants PA, Department of Research, Houston, Texas (Dr Peguero); Baylor Scott & White Medical Center, Temple, Texas (Dr Garland); and TerSera Therapeutics, Deerfield, Illinois (Ms North and Drs Young, Brent, and Joseph-Ridge).'}, {'ForeName': 'Lonnie D', 'Initials': 'LD', 'LastName': 'Brent', 'Affiliation': 'St. Joseph Health Cancer Center, Santa Rosa, California (Dr Holmes); Oncology Consultants PA, Department of Research, Houston, Texas (Dr Peguero); Baylor Scott & White Medical Center, Temple, Texas (Dr Garland); and TerSera Therapeutics, Deerfield, Illinois (Ms North and Drs Young, Brent, and Joseph-Ridge).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Joseph-Ridge', 'Affiliation': 'St. Joseph Health Cancer Center, Santa Rosa, California (Dr Holmes); Oncology Consultants PA, Department of Research, Houston, Texas (Dr Peguero); Baylor Scott & White Medical Center, Temple, Texas (Dr Garland); and TerSera Therapeutics, Deerfield, Illinois (Ms North and Drs Young, Brent, and Joseph-Ridge).'}]",Journal of infusion nursing : the official publication of the Infusion Nurses Society,['10.1097/NAN.0000000000000444']
1716,34565444,Integrating traditional practices and social network visualization to prevent substance use: study protocol for a randomized controlled trial among urban Native American emerging adults.,"BACKGROUND


Nonmedical use of prescription opioids (defined as taking opioid medications for hedonic effects or in a manner other than prescribed) and the use of heroin have emerged in recent years as major public health concerns in the United States. Of particular concern is the prevalence of opioid use among emerging adults (ages 18-25), as this is a developmental period of heightened vulnerability and critical social, neurological, and psychological development. Data from 2015 show that American Indian/Alaska Native (AI/AN) people have the highest rates of diagnosis for opioid use disorders (OUDs). One recent study found that the overdose death rate among urban-dwelling AI/AN individuals was 1.4 times higher compared to those living in rural areas. To date, there are no evidence-based prevention programs addressing opioid use among urban AI/AN emerging adults that integrate culturally-appropriate strategies with evidence-based treatment. Traditions and Connections for Urban Native Americans (TACUNA) builds on our prior work with AI/AN communities across California to develop and evaluate culturally appropriate programming to address opioid, alcohol, and cannabis use among urban AI/AN emerging adults.
METHODS/DESIGN


In a randomized controlled trial, 18-25 year old urban AI/AN emerging adults will receive either TACUNA (n = 185), which comprises three virtual workshops utilizing motivational interviewing, social network visualization, and integrating traditional practices and a wellness circle, or one virtual culturally sensitive opioid education workshop (n = 185). We will evaluate intervention effects on primary outcomes of frequency of opioid, alcohol, and cannabis use, as well as secondary outcomes of social network characteristics and cultural connectedness, over a 12-month period.
DISCUSSION


This project has the potential to expand the range and effectiveness of opioid, alcohol, and cannabis services for urban AI/AN emerging adults by addressing the opioid epidemic and use of other substances at both the community and individual level. In addition, it provides important culturally grounded conceptual and practical information to advance the field of substance use interventions and enhance resiliency among this population.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04617938. Registered October 26, 2020 https://clinicaltrials.gov/ct2/show/record/NCT04617938 .",2021,"This project has the potential to expand the range and effectiveness of opioid, alcohol, and cannabis services for urban AI/AN emerging adults by addressing the opioid epidemic and use of other substances at both the community and individual level.","['urban Native American emerging adults', 'Urban Native Americans (TACUNA', '18-25\xa0year old urban AI/AN emerging adults', 'adults (ages 18-25', 'urban-dwelling AI']","['virtual workshops utilizing motivational interviewing, social network visualization, and integrating traditional practices and a wellness circle, or one virtual culturally sensitive opioid education workshop', 'TACUNA']","['overdose death rate', 'frequency of opioid, alcohol, and cannabis use']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}]",,0.0756063,"This project has the potential to expand the range and effectiveness of opioid, alcohol, and cannabis services for urban AI/AN emerging adults by addressing the opioid epidemic and use of other substances at both the community and individual level.","[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': ""D'Amico"", 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2136, Santa Monica, CA, 90407-2138, USA. damico@rand.org.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Dickerson', 'Affiliation': 'UCLA Integrated Substance Abuse Programs (ISAP), Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine, 1640 Sepulveda Blvd., Suite 200, Los Angeles, CA, 90025, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'RAND Corporation, 20 Park Plaza, Suite 920, Boston, MA, 02116, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2136, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kennedy', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2136, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Alina I', 'Initials': 'AI', 'LastName': 'Palimaru', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2136, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Sacred Path Indigenous Wellness Center, Los Angeles, CA, 90017, USA.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Smart', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2136, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Klein', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2136, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2136, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Keisha', 'Initials': 'K', 'LastName': 'McDonald', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2136, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Woodward', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2136, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Ninna', 'Initials': 'N', 'LastName': 'Gudgell', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2136, Santa Monica, CA, 90407-2138, USA.'}]",Addiction science & clinical practice,['10.1186/s13722-021-00265-3']
1717,34563982,Low-dose aspirin increases 15-epi-lipoxins A 4  in pregnancies at high-risk for developing preeclampsia.,"BACKGROUND


LDA triggers biosynthesis of endogenous anti-inflammatory molecules, aspirin-triggered 15-epi-lipoxin A 4  (15-epi-LXA 4 ), which may counteract inflammatory process of preeclampsia (PE), and play role in LDA's mechanism of action in PE prevention in high-risk patients.
OBJECTIVE


Investigate the effects of daily LDA on levels of 15-epi-LXA 4  in pregnancies at high-risk for developing PE.
MATERIALS AND METHODS


Secondary analysis of multi-centered randomized controlled trial investigating effects of daily LDA (60 mg) in high-risk pregnancies. Maternal samples were drawn at three points: before LDA initiation (13-26 weeks' gestation), 24-28 weeks' gestation (at least two weeks after LDA) and 34-36 weeks' gestation. 15-epi-LXA 4  levels were measured by ELISA.
RESULTS


Analysis included 82 patients: 63 receiving daily LDA and 29 receiving daily placebo starting between 13 and 25 weeks gestation. Prior to randomization, baseline 15-epi-LXA 4  levels were similar between both groups (75.9 pg/mL [IQR; 63.8-114.0] vs 136.2 pg/mL [52.4-476.2]; p = 0.10). Patients receiving daily LDA were noted to have significantly increased levels of 15-epi-LXA 4  after LDA administration (136.2 pg/mL [IQR; 52.4-476.2] vs 1758.2 pg/mL [905.4-6638.5]; p < 0.001). They also had higher 15-epi-LXA 4  levels compared to those receiving placebo at 24-28 weeks' (50.3 [38.1-94.2] vs 1758.2 [905.4-6638.5]; p < 0.001 and 34-38 weeks' gestation (57.9 [41.9-76.7] vs 2310.3 pg/mL [656.9-10609.4]; p < 0.001). After LDA administration in the second trimester, patients who developed PE had decrease in 15-epi-LXA 4  levels compared to those without PE (942 pg/mL [348.3-1810.3] vs 1758.2 pg/mL [905.4-6638.5]; p = 0.129).
CONCLUSION


Daily LDA administration increases 15-epi-LXA 4  levels in high-risk pregnancies for PE. In LDA group, pregnancies complicated by PE have lower levels of 15-epi-LXA 4  compared to pregnancies without PE.",2021,They also had higher 15-epi-LXA 4  levels compared to those receiving placebo at 24-28 weeks' (50.3 [38.1-94.2] vs 1758.2 [905.4-6638.5]; p < 0.001 and 34-38 weeks' gestation (57.9,"['82 patients: 63 receiving daily LDA and 29 receiving daily', 'high-risk pregnancies', 'pregnancies at high-risk for developing PE']","['daily LDA', 'Daily LDA', 'placebo', 'Low-dose aspirin']","['levels of 15-epi-LXA', '15-epi-LXA 4  levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0242786', 'cui_str': 'High risk pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0456950', 'cui_str': 'Level 4'}]",,0.306571,They also had higher 15-epi-LXA 4  levels compared to those receiving placebo at 24-28 weeks' (50.3 [38.1-94.2] vs 1758.2 [905.4-6638.5]; p < 0.001 and 34-38 weeks' gestation (57.9,"[{'ForeName': 'Veronica M', 'Initials': 'VM', 'LastName': 'Gonzalez-Brown', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, San Antonio Uniformed Services Health Science Consortium, Brooke Army Medical Center, Ft Sam Houston, TX, United States. Electronic address: veronica.m.gonzalez2.mil@mail.mil.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': ""Ma'ayeh"", 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH, United States.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Kniss', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cackovic', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH, United States.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Landon', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH, United States.'}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Rood', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH, United States.'}]",Pregnancy hypertension,['10.1016/j.preghy.2021.09.003']
1718,34563585,"Lowering of blood pressure and pulse rate by switching from DPP-4 inhibitor to luseogliflozin in patients with type 2 diabetes complicated with hypertension: A multicenter, prospective, randomized, open-label, parallel-group comparison trial (LUNA study).","AIMS


Sodium-glucose cotransporter-2 inhibitor (SGLT2i) reduces clinic blood pressure (BP), but the effects on BP circadian rhythm remain unclear. The present study aimed to determine the nighttime antihypertensive effect of SGLT2i compared with dipeptidyl peptidase-4 inhibitor (DPP-4i) in patients with type 2 diabetes and hypertension.
MATERIALS AND METHODS


In this randomized, open-label, parallel-group trial, patients treated with DPP-4i were either switched to luseogliflozin 2.5 mg/day (Luseo group;n = 30) or continued DPP-4i (DPP-4i group;n = 26). The patients undertook 24-h ambulatory BP monitoring before and 8 weeks after the group allocation. The primary endpoint was mean change in nighttime systolic BP (SBP).
RESULTS


Nighttime SBP, as well as daytime SBP, was significantly reduced in the Luseo group compared with the DPP-4i group (nighttime, -4.0 ± 11.4 vs. 3.6 ± 10.7 mmHg,P = 0.01; daytime, -4.4 ± 10.9 vs. 3.7 ± 11.9 mmHg,P = 0.01). Similarly, nighttimepulse rate(PR) was significantly reduced in the Luseo group (-2.0 ± 4.8 vs. 0.9 ± 4.8 bpm,P = 0.03). The proportion of patients with abnormal BP circadian rhythms (non-dipper pattern plus riser pattern) was significantly lower in the Luseo group (36.6% vs. 56.7%,P < 0.05).
CONCLUSIONS


Switching from DPP-4i to luseogliflozin decreased nighttime SBP and PR; moreover, BP circadian rhythm was improved.",2021,"The proportion of patients with abnormal BP circadian rhythms (non-dipper pattern plus riser pattern) was significantly lower in the Luseo group (36.6% vs. 56.7%,P<0.05).
","['patients with type 2 diabetes and hypertension', 'patients with type 2 diabetes complicated with hypertension']","['SGLT2i', 'dipeptidyl peptidase-4 inhibitor (DPP-4i', 'luseogliflozin 2.5 mg/day (Luseo group;n=30) or continued DPP-4i (DPP-4i group;n=26', 'Sodium-glucose cotransporter-2 inhibitor (SGLT2i', 'DPP-4i', 'DPP-4 inhibitor to luseogliflozin']","['nighttime SBP and PR', 'nighttime antihypertensive effect', 'BP circadian rhythm', 'mean change in nighttime systolic BP (SBP', 'Nighttime SBP', 'proportion of patients with abnormal BP circadian rhythms', 'daytime SBP', 'blood pressure and pulse rate', 'nighttimepulse rate(PR', 'clinic blood pressure (BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C2933904', 'cui_str': '1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005826', 'cui_str': 'Abnormal blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",,0.0314654,"The proportion of patients with abnormal BP circadian rhythms (non-dipper pattern plus riser pattern) was significantly lower in the Luseo group (36.6% vs. 56.7%,P<0.05).
","[{'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Hashimoto-Kameda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan.'}, {'ForeName': 'Kyu Yong', 'Initials': 'KY', 'LastName': 'Cho', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan; Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nomoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan.'}, {'ForeName': 'Kazuno', 'Initials': 'K', 'LastName': 'Omori', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan.'}, {'ForeName': 'So', 'Initials': 'S', 'LastName': 'Nagai', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Medicine, Sapporo Medical Center, NTT East Corporation, Minami 1, Nishi 15, Chuo-ku, Sapporo 060-0061, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Edagawa', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Kawata', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeuchi', 'Affiliation': 'Sapporo Diabetes, Thyroid Clinic, Kita 7, Nishi 2-8-1, Kita-ku, Sapporo 060-0807, Japan.'}, {'ForeName': 'Hiraku', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Kurihara Clinic, Atsubetsuchuo 3-5-7-28, Atsubetsu-ku, Sapporo 004-0053, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Aoki Clinic, Nangodori 1-Kita 1-1-5F, Shiroisi-ku, Sapporo 003-0023, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan; Division of Diabetes and Obesity, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan. Electronic address: hmiyoshi@med.hokudai.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2021.109069']
1719,34563227,Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial.,"BACKGROUND


Serious illness conversations (SICs) are an evidence-based approach to eliciting patients' values, goals, and care preferences that improve patient outcomes. However, most patients with cancer die without a documented SIC. Clinician-directed implementation strategies informed by behavioral economics (""nudges"") that identify high-risk patients have shown promise in increasing SIC documentation among clinicians. It is unknown whether patient-directed nudges that normalize and prime patients towards SIC completion-either alone or in combination with clinician nudges that additionally compare performance relative to peers-may improve on this approach. Our objective is to test the effect of clinician- and patient-directed nudges as implementation strategies for increasing SIC completion among patients with cancer.
METHODS


We will conduct a 2 × 2 factorial, cluster randomized pragmatic trial to test the effect of nudges to clinicians, patients, or both, compared to usual care, on SIC completion. Participants will include 166 medical and gynecologic oncology clinicians practicing at ten sites within a large academic health system and their approximately 5500 patients at high risk of predicted 6-month mortality based on a validated machine-learning prognostic algorithm. Data will be obtained via the electronic medical record, clinician survey, and semi-structured interviews with clinicians and patients. The primary outcome will be time to SIC documentation among high-risk patients. Secondary outcomes will include time to SIC documentation among all patients (assessing spillover effects), palliative care referral among high-risk patients, and aggressive end-of-life care utilization (composite of chemotherapy within 14 days before death, hospitalization within 30 days before death, or admission to hospice within 3 days before death) among high-risk decedents. We will assess moderators of the effect of implementation strategies and conduct semi-structured interviews with a subset of clinicians and patients to assess contextual factors that shape the effectiveness of nudges with an eye towards health equity.
DISCUSSION


This will be the first pragmatic trial to evaluate clinician- and patient-directed nudges to promote SIC completion for patients with cancer. We expect the study to yield insights into the effectiveness of clinician and patient nudges as implementation strategies to improve SIC rates, and to uncover multilevel contextual factors that drive response to these strategies.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT04867850 . Registered on April 30, 2021.
FUNDING


National Cancer Institute P50CA244690.",2021,"We will conduct a 2 × 2 factorial, cluster randomized pragmatic trial to test the effect of nudges to clinicians, patients, or both, compared to usual care, on SIC completion.","['Participants will include 166 medical and gynecologic oncology clinicians practicing at ten sites within a large academic health system and their approximately 5500 patients at high risk of predicted 6-month mortality based on a validated machine-learning prognostic algorithm', 'clinicians and high-risk patients with cancer', 'patients with cancer die without a documented SIC', 'patients with cancer']","['clinician', 'Behavioral economic implementation strategies']","['time to SIC documentation among high-risk patients', 'time to SIC documentation among all patients (assessing spillover effects), palliative care referral among high-risk patients, and aggressive end-of-life care utilization (composite of chemotherapy within 14 days before death, hospitalization within 30 days before death, or admission to hospice within 3 days before death']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0583223', 'cui_str': 'Admission to hospice'}]",,0.173197,"We will conduct a 2 × 2 factorial, cluster randomized pragmatic trial to test the effect of nudges to clinicians, patients, or both, compared to usual care, on SIC completion.","[{'ForeName': 'Samuel U', 'Initials': 'SU', 'LastName': 'Takvorian', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA. Samuel.Takvorian@pennmedicine.upenn.edu.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Bekelman', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Alicia B W', 'Initials': 'ABW', 'LastName': 'Clifton', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Tasnim', 'Initials': 'T', 'LastName': 'Salam', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gabriel', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'E Paul', 'Initials': 'EP', 'LastName': 'Wileyto', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Callie A', 'Initials': 'CA', 'LastName': 'Scott', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Buttenheim', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Rendle', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Krisda', 'Initials': 'K', 'LastName': 'Chaiyachati', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Ware', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Chivers', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Schuchter', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Lawrence N', 'Initials': 'LN', 'LastName': 'Shulman', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': ""O'Connor"", 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Adina', 'Initials': 'A', 'LastName': 'Lieberman', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Zentgraf', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Ravi B', 'Initials': 'RB', 'LastName': 'Parikh', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.'}]",Implementation science : IS,['10.1186/s13012-021-01156-6']
1720,34255755,Changes to Corneal Topography and Biometrics After PRESERFLO Microshunt Surgery for Glaucoma.,"PRECIS


Glaucoma surgery with PRESERFLO Microshunt shows mild and transient changes in the corneal astigmatism, corneal elevation and biometrics in the early postoperative period. Posterior corneal elevation (PCE) tends to be higher in primary open angle glaucoma (POAG).
PURPOSE


The aim was to determine the changes in the corneal keratometry, astigmatism and elevation, refraction, axial length (AL) and anterior chamber depth and volume after the implantation of the PRESERFLO Microshunt in patients with POAG in the early postoperative period.
PATIENTS AND METHODS


Patients diagnosed with POAG who underwent an ab externo (polystyrene-block-isobutylene-block-styrene) microshunt implantation were recruited. The central corneal thickness, the intraocular pressure (IOP), best-corrected visual acuity, refraction, biometrics, and corneal topography with a Scheimpflug topographer were analyzed preoperatively and 24 hours, 1 week, 1 month, and 3 months after surgery.
RESULTS


A total of 30 eyes of 29 patients were included. In 24 eyes the device was implanted as a stand-alone procedure and in 6 eyes it was combined with cataract surgery. The results were analyzed separately. The IOP decreased from 21.8±5.2 and 16.5±1.5 mm Hg at baseline to 10.9±1.8 and 10.1±1.1 mm Hg at 3 months in the noncombined and combined groups (P<0.01). The anterior surface astigmatism, posterior surface astigmatism, and total corneal astigmatism increased in each group 0.4±0.3/0.2±1.0 D, 0.08±0.1/0.03±0.1 D and 0.4±0.3/0.2±0.9 D, respectively, at 3 months. The anterior corneal elevation and PCE (ACE max, ACE min, PCE max) increased in the first week (P=0.01) with no significant changes at 3 months in the noncombined group. The changes observed in the combined group were not significant. The AL decreased to 0.13±0.23 and 0.2±0.07 mm in each group (P=0.01). There was a significant correlation between the IOP and the maximum elevation of the posterior surface of the cornea at the preoperative examination (r=0.93, P=0.02).
CONCLUSIONS


The PRESERFLO Microshunt implant for glaucoma surgery induces mild and transient changes in corneal astigmatism, AL and anterior chamber depth in the early postoperative period.",2021,"The anterior corneal elevation and PCE (ACE max, ACE min, PCE max) increased in the first week (P=0.01) with no significant changes at 3 months in the noncombined group.","['Patients diagnosed with POAG who underwent an ab externo (polystyrene-block-isobutylene-block-styrene) microshunt implantation were recruited', 'patients with POAG in the early postoperative period', 'A total of 30 eyes of 29 patients were included']",[],"['IOP', 'AL', 'Corneal Topography and Biometrics', 'anterior surface astigmatism, posterior surface astigmatism, and total corneal astigmatism', 'corneal astigmatism, AL and anterior chamber depth', 'anterior corneal elevation and PCE (ACE max, ACE min, PCE max', 'corneal keratometry, astigmatism and elevation, refraction, axial length (AL) and anterior chamber depth and volume', 'corneal astigmatism, corneal elevation and biometrics', 'IOP and the maximum elevation of the posterior surface of the cornea at the preoperative examination', 'Posterior corneal elevation (PCE', 'central corneal thickness, the intraocular pressure (IOP), best-corrected visual acuity, refraction, biometrics, and corneal topography with a Scheimpflug topographer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0032604', 'cui_str': 'Polystyrene'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0063930', 'cui_str': 'isobutylene'}, {'cui': 'C0038513', 'cui_str': 'Styrenes'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",29.0,0.105022,"The anterior corneal elevation and PCE (ACE max, ACE min, PCE max) increased in the first week (P=0.01) with no significant changes at 3 months in the noncombined group.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ibarz Barberá', 'Affiliation': 'Oftalvist Group.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Morales-Fernandez', 'Affiliation': 'Clinic Hospital San Carlos.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Gómez de Liaño', 'Affiliation': 'Clinic Hospital San Carlos.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Tañá Rivero', 'Affiliation': 'Oftalvist Group, Alicante, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Teus', 'Affiliation': 'Novovision Clinic.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001912']
1721,34590235,Recruitment into a Clinical Trial of People Living with Uncontrolled HIV Infection Who Inject Drugs: a Site Case Report from the CTN 67 CHOICES Study.,"CHOICES was an open-label, randomized, comparative effectiveness trial of office-based extended-release naltrexone versus treatment as usual in people with untreated opioid use disorder and HIV. This study explored facilitators to recruitment in Miami, a successful recruiting site in the national trial. The mixed-methods study included quantitative surveys of randomized participants, medical record abstraction, and qualitative interviews with study staff. Miami recruited 47 (40.5%) of 116 randomized participants in the six-site national trial. In-depth interviews of study staff (n = 6) revealed that Miami had a recruitment approach consisting of street level outreach and a close relationship with the local syringe services program (SSP). Partnership with a local SSP provided access to people living with HIV who inject drugs in Miami. SSPs' fundamental trust within the community of people who inject drugs can be leveraged in studies aiming to improve health outcomes in this underserved and high-priority population.",2021,SSPs' fundamental trust within the community of people who inject drugs can be leveraged in studies aiming to improve health outcomes in this underserved and high-priority population.,"['People Living with Uncontrolled HIV Infection', 'people with untreated opioid use disorder and HIV', 'Miami recruited 47 (40.5%) of 116 randomized participants in the six-site national trial', 'people living with HIV who inject drugs in Miami']","['local syringe services program (SSP', 'Inject Drugs', 'office-based extended-release naltrexone']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]",[],116.0,0.18564,SSPs' fundamental trust within the community of people who inject drugs can be leveraged in studies aiming to improve health outcomes in this underserved and high-priority population.,"[{'ForeName': 'Hansel', 'Initials': 'H', 'LastName': 'Tookes', 'Affiliation': 'Department of Medicine, Miller School of Medicine, University of Miami, 1120 NW 14th St, Miami, FL, 33136, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ucha', 'Affiliation': 'Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th St, Miami, FL, 33136, USA. jucha@med.miami.edu.'}, {'ForeName': 'Allan E', 'Initials': 'AE', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Medicine, Miller School of Medicine, University of Miami, 1120 NW 14th St, Miami, FL, 33136, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Suarez', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th St, Miami, FL, 33136, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Alonso', 'Affiliation': 'Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th St, Miami, FL, 33136, USA.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, 10027, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th St, Miami, FL, 33136, USA.'}, {'ForeName': 'Tyler S', 'Initials': 'TS', 'LastName': 'Bartholomew', 'Affiliation': 'Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th St, Miami, FL, 33136, USA.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Hoffman', 'Affiliation': 'Oregon Health and Science University-Portland State University School of Public Health, 3181 Sam Jackson Park Rd, Portland, OR, 97239, USA.'}, {'ForeName': 'P Todd', 'Initials': 'PT', 'LastName': 'Korthuis', 'Affiliation': 'Department of Medicine, Section of Addiction Medicine, Oregon Health and Science University, Portland, OR, 97239, USA.'}]",The journal of behavioral health services & research,['10.1007/s11414-021-09771-3']
1722,34590159,Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study-a randomized clinical trial.,"PURPOSE


Hyperglycaemia is an adaptive response to stress commonly observed in critical illness. Its management remains debated in the intensive care unit (ICU). Individualising hyperglycaemia management, by targeting the patient's pre-admission usual glycaemia, could improve outcome.
METHODS


In a multicentre, randomized, double-blind, parallel-group study, critically-ill adults were considered for inclusion. Patients underwent until ICU discharge either individualised glucose control by targeting the pre-admission usual glycaemia using the glycated haemoglobin A1c level at ICU admission (IC group), or conventional glucose control by maintaining glycaemia below 180 mg/dL (CC group). A non-commercial web application of a dynamic sliding-scale insulin protocol gave to nurses all instructions for glucose control in both groups. The primary outcome was death within 90 days.
RESULTS


Owing to a low likelihood of benefit and evidence of the possibility of harm related to hypoglycaemia, the study was stopped early. 2075 patients were randomized; 1917 received the intervention, 942 in the IC group and 975 in the CC group. Although both groups showed significant differences in terms of glycaemic control, survival probability at 90-day was not significantly different (IC group: 67.2%, 95% CI [64.2%; 70.3%]; CC group: 69.6%, 95% CI [66.7%; 72.5%]). Severe hypoglycaemia (below 40 mg/dL) occurred in 3.9% of patients in the IC group and in 2.5% of patients in the CC group (p = 0.09). A post hoc analysis showed for non-diabetic patients a higher risk of 90-day mortality in the IC group compared to the CC group (HR 1.3, 95% CI [1.05; 1.59], p = 0.018).
CONCLUSION


Targeting an ICU patient's pre-admission usual glycaemia using a dynamic sliding-scale insulin protocol did not demonstrate a survival benefit compared to maintaining glycaemia below 180 mg/dL.",2021,Severe hypoglycaemia (below 40 mg/dL) occurred in 3.9% of patients in the IC group and in 2.5% of patients in the CC group (p = 0.09).,"['2075 patients were randomized; 1917 received the intervention, 942 in the IC group and 975 in the CC group', 'critically-ill adults', 'critically-ill patients']","['until ICU discharge either individualised glucose control by targeting the pre-admission usual glycaemia using the glycated haemoglobin A1c level at ICU admission (IC group), or conventional glucose control by maintaining glycaemia below 180\xa0mg/dL (CC', 'Individualised versus conventional glucose control']","['Severe hypoglycaemia', 'death within 90\xa0days', 'glycaemic control, survival probability', '90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517911', 'cui_str': '975'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0559269', 'cui_str': 'Pre-admission'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",2075.0,0.0890039,Severe hypoglycaemia (below 40 mg/dL) occurred in 3.9% of patients in the IC group and in 2.5% of patients in the CC group (p = 0.09).,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Bohé', 'Affiliation': ""Service d'Anesthésie-Réanimation-Médecine intensive, Groupement hospitalier sud, Hospices Civils de Lyon, 165 Chemin du grand Revoyet, 69310, Pierre Bénite, France. julien.bohe@chu-lyon.fr.""}, {'ForeName': 'Hassane', 'Initials': 'H', 'LastName': 'Abidi', 'Affiliation': ""Service d'Anesthésie-Réanimation-Médecine intensive, Groupement hospitalier sud, Hospices Civils de Lyon, 165 Chemin du grand Revoyet, 69310, Pierre Bénite, France.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Brunot', 'Affiliation': 'Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire, Montpellier, France.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Klich', 'Affiliation': 'Service de Biostatistique-Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Kada', 'Initials': 'K', 'LastName': 'Klouche', 'Affiliation': 'Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire, Montpellier, France.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Sedillot', 'Affiliation': 'Service de réanimation, Hôpital Fleyriat, Bourg en Bresse, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Tchenio', 'Affiliation': 'Service de réanimation, Hôpital Fleyriat, Bourg en Bresse, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': 'Service de Médecine Intensive Réanimation, CHU Dijon Bourgogne, Dijon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Roudaut', 'Affiliation': 'Service de Médecine Intensive Réanimation, CHU Dijon Bourgogne, Dijon, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Mottard', 'Affiliation': ""Service d'Anesthésie-Réanimation-Médecine intensive, Groupement hospitalier sud, Hospices Civils de Lyon, 165 Chemin du grand Revoyet, 69310, Pierre Bénite, France.""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Thiollière', 'Affiliation': ""Service d'Anesthésie-Réanimation-Médecine intensive, Groupement hospitalier sud, Hospices Civils de Lyon, 165 Chemin du grand Revoyet, 69310, Pierre Bénite, France.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dellamonica', 'Affiliation': ""Service de Médecine Intensive Réanimation, CHU Hôpital de l'Archet, Nice, France.""}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Wallet', 'Affiliation': ""Service d'Anesthésie-Réanimation-Médecine intensive, Groupement hospitalier sud, Hospices Civils de Lyon, 165 Chemin du grand Revoyet, 69310, Pierre Bénite, France.""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Souweine', 'Affiliation': 'Service de Médecine Intensive Réanimation, CHU Hôpital Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Service de Médecine Intensive Réanimation, CHU Hôpital Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Preiser', 'Affiliation': 'Department of Intensive Care, Erasme University Hospital, Université libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Timsit', 'Affiliation': 'Réanimation Médicale et des Maladies infectieuses, Université Paris Diderot/Hôpital Bichat, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Charles-Hervé', 'Initials': 'CH', 'LastName': 'Vacheron', 'Affiliation': ""Service d'Anesthésie-Réanimation-Médecine intensive, Groupement hospitalier sud, Hospices Civils de Lyon, 165 Chemin du grand Revoyet, 69310, Pierre Bénite, France.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ait Hssain', 'Affiliation': 'Service de Médecine Intensive Réanimation, CHU Hôpital Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Maucort-Boulch', 'Affiliation': 'Service de Biostatistique-Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-021-06526-8']
1723,34560431,"Effects of combined whole body vibration and resistance training on lower quadrants electromyographic activity, muscle strength and power in athletes.","BACKGROUND


Whole body vibration (WBV) with resistance training is one of the increasing ways of gaining ankle and foot complex muscle strength and power for the rehabilitative and prophylactic purpose in athletes.
OBJECTIVE


The purpose of the study was to compare the effects of combined WBV and resistance training (RVE) with strength training alone (RE) on alteration of gastrocnemius lateralis and vastus medialis obliquus muscle activity and strength, and power performance in athletes.
METHODS


The study was performed on 23 university-level male athletes who were randomized into two groups as RVE (n = 12; age 22.2 ± 1.94 years) and RE (n = 11; age 21.60 ± 1.78 years). The training program was scheduled three times per week for six weeks (18 sessions). Gastrocnemius lateralis (GL) and vastus medialis obliquus (VMO) were measured for muscle activity and isometric strength with surface EMG device and handheld dynamometer respectively. Counter-movement jump (CMJ) was used for measuring power. All the participants were assessed for outcome measures at baseline and then after 6 weeks. Group (RVE vs. RE) by time (pre vs. post) effects were compared through a 2-way interaction utilizing mixed model repeated measure ANOVA.
RESULTS


After training, VMO muscle activity (group effects) increased significantly in the RVE group (p < 0.05). However, both the groups showed statistically significant time and group × time interaction effects for muscle activity of VMO, isometric strength (VMO and GL), and CMJ (p < 0.05).
CONCLUSION


WBV might serve as an adjunct modality for enhancement of the neuromuscular activity of the VMO muscle. However, RVE had no additive effect when compared to RE alone on muscle strength and power in athletes. The long-term impacts of combined WBV and resistance training on other foot and ankles muscle should be investigated in future studies.",2021,"After training, VMO muscle activity (group effects) increased significantly in the RVE group (p < 0.05).","['athletes', '23 university-level male athletes who were randomized into two groups as RVE (n = 12; age 22.2 ± 1.94 years) and RE (n = 11; age 21.60 ± 1.78 years']","['RVE', 'combined whole body vibration and resistance training', 'combined WBV and resistance training', 'combined WBV and resistance training (RVE) with strength training alone (RE', 'Counter-movement jump (CMJ', 'RE']","['Gastrocnemius lateralis (GL) and vastus medialis obliquus (VMO', 'muscle activity and isometric strength with surface EMG device and handheld dynamometer respectively', 'muscle strength and power in athletes', 'time interaction effects for muscle activity of VMO, isometric strength (VMO and GL), and CMJ', 'lower quadrants electromyographic activity, muscle strength and power', 'VMO muscle activity', 'alteration of gastrocnemius lateralis and vastus medialis obliquus muscle activity and strength, and power performance']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]","[{'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.00682277,"After training, VMO muscle activity (group effects) increased significantly in the RVE group (p < 0.05).","[{'ForeName': 'Nitin Kumar', 'Initials': 'NK', 'LastName': 'Arora', 'Affiliation': 'Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, A Central University, New Delhi, India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, A Central University, New Delhi, India. Electronic address: ssharma@jmi.ac.in.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Saifi', 'Affiliation': 'Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, A Central University, New Delhi, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Enrich Physio Clinics, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ishant Kumar', 'Initials': 'IK', 'LastName': 'Arora', 'Affiliation': 'Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, A Central University, New Delhi, India.'}]","Foot (Edinburgh, Scotland)",['10.1016/j.foot.2021.101844']
1724,34560393,The effect of using standardized patients in the Simulated Hospital Environment on first-year nursing students psychomotor skills learning.,"BACKGROUND


The aim of this study was to determine the effect of using standardized patients in the Simulated Hospital Environment on first-year nursing students' psychomotor skills.
METHODS


This semi-experimental study was carried out in the one-group pretest-posttest design. Students performed the psychomotor skills in the Non-Simulated Clinical Skill Laboratory and Simulated Hospital Environment. The skill performances of the students were evaluated with the Objective Structured Clinical Assessment form. At the same time, students' views on both environments were received.
RESULTS


Students' mean Objective Structured Clinical Assessment score in the Simulated Hospital Environment (69.42 ± 10.94) was significantly higher than their mean score in the Non-Simulated Clinical Skill Laboratory (57.07 ± 10.05) (p < 0.05). The differences in scores were particularly significant in the stages of meeting the patient, performing the procedure in accordance with the steps and ending the procedure. The majority of the students stated that they could not do some applications in the Non-Simulated Clinical Skill Laboratory in a similar way to the hospital clinic (85.9%), and they felt like they were in a real hospital clinic in the Simulated Hospital Environment (100%).
CONCLUSIONS


The results showed that students developed psychomotor skills more fully in a learning environment designed in a similar way to a real hospital clinic setting.",2021,"RESULTS


Students' mean Objective Structured Clinical Assessment score in the Simulated Hospital Environment (69.42 ± 10.94) was significantly higher than their mean score in the Non-Simulated Clinical Skill Laboratory (57.07 ± 10.05) (p < 0.05).","[""standardized patients in the Simulated Hospital Environment on first-year nursing students' psychomotor skills"", 'standardized patients in the Simulated Hospital Environment on first-year nursing students psychomotor skills learning']",[],"['psychomotor skills', 'mean Objective Structured Clinical Assessment score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.0466568,"RESULTS


Students' mean Objective Structured Clinical Assessment score in the Simulated Hospital Environment (69.42 ± 10.94) was significantly higher than their mean score in the Non-Simulated Clinical Skill Laboratory (57.07 ± 10.05) (p < 0.05).","[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Kol', 'Affiliation': 'Akdeniz University Faculty of Nursing, Turkey. Electronic address: ekol@akdeniz.edu.tr.'}, {'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Ince', 'Affiliation': 'Akdeniz University Faculty of Nursing, Turkey.'}, {'ForeName': 'Rabiye Demir', 'Initials': 'RD', 'LastName': 'Işik', 'Affiliation': 'Akdeniz University Faculty of Nursing, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Ilaslan', 'Affiliation': 'Akdeniz University Faculty of Health Sciences, Turkey.'}, {'ForeName': 'Sümer', 'Initials': 'S', 'LastName': 'Mamakli', 'Affiliation': 'Akdeniz University Faculty of Medicine, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2021.105147']
1725,34559956,"A single-center, open-label, randomized cross-over study to evaluate the pharmacokinetics and bioavailability of once-daily prolonged-release formulations of tacrolimus in de novo liver transplant recipients.","BACKGROUND


The narrow therapeutic window of tacrolimus (Tac) requires intense drug monitoring to achieve adequate efficacy while minimizing dose-related toxicities. Once-daily formulations of Tac (LCP-Tac and PR-Tac) have been recently designed for higher bioavailability and a more consistent exposure over time, as opposed to the twice-daily, administered immediate-release formulation of Tac (IR-Tac).
METHODS


This single-center, open-label, randomized cross-over pharmacokinetic (PK) study compares extended-release LCP-Tac with the prolonged-release formulation of tacrolimus (PR-Tac) in adult de novo liver transplant recipients. Eligible patients were screened and randomized 1:1 to the two treatment arms up to 30 days after liver transplantation. Patients were administered either LCP-Tac or PR-Tac for 14 days followed by another 14-day time interval of the other once-daily Tac medication. A 24hr-PK profile was obtained at the end of each time interval.
RESULTS


Nine patients (45%) completed the study resulting in a total of 18 Tac PK profiles. Overall, the profile of the mean concentrations indicated a flattened kinetic of LCP-Tac compared to PR-Tac, especially in the first 3 h after drug intake. The average cumulative dose per day to achieve equivalent trough levels was approximately 25% lower for LCP-Tac (8.7 mg) than for PR-Tac (11.7 mg). LCP-Tac resulted in a longer t max  and fewer peak-to-trough fluctuations compared to PR-Tac.
CONCLUSION


Despite methodological weaknesses that limit the conclusions, we have found a more consistent drug exposure for LCP-Tac in de novo LT recipients. LCP-Tac demonstrated a greater bioavailability compared to PR-Tac.",2021,"LCP-Tac resulted in a longer t max  and fewer peak-to-trough fluctuations compared to PR-Tac.
CONCLUSION


Despite methodological weaknesses that limit the conclusions, we have found a more consistent drug exposure for LCP-Tac in de novo LT recipients.","['Eligible patients', 'de novo liver transplant recipients', 'adult de novo liver transplant recipients']","['tacrolimus', 'Tac (LCP-Tac and PR-Tac', 'tacrolimus (PR-Tac', 'LCP-Tac or PR-Tac', 'LCP-Tac', 'tacrolimus (Tac']","['pharmacokinetics and bioavailability', 'bioavailability', 'average cumulative dose per day to achieve equivalent trough levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0433001,"LCP-Tac resulted in a longer t max  and fewer peak-to-trough fluctuations compared to PR-Tac.
CONCLUSION


Despite methodological weaknesses that limit the conclusions, we have found a more consistent drug exposure for LCP-Tac in de novo LT recipients.","[{'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Herden', 'Affiliation': 'Department of Visceral Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Sterneck', 'Affiliation': 'Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bettina M', 'Initials': 'BM', 'LastName': 'Buchholz', 'Affiliation': 'Department of Visceral Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Eike G', 'Initials': 'EG', 'LastName': 'Achilles', 'Affiliation': 'Department of Visceral Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Ott', 'Affiliation': 'Institute of Medical Informatics, Statistics and Epidemiology, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Fischer', 'Affiliation': 'Department of Visceral Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]","Immunity, inflammation and disease",['10.1002/iid3.537']
1726,34562682,Effect of guided reciprocal peer questioning strategy on pediatric nursing students' self-esteem and metacognitive awareness: Current approach and future directions.,"BACKGROUND


Guided Reciprocal Peer Questioning Strategy (GRPQS) restructures the classroom context from a passive into an engaging environment, where the students are empowered to actively participating in their learning process.
OBJECTIVE


To investigate the impact of GRPQS on the pediatric nursing students' self-esteem and metacognitive awareness.
DESIGN


A Quasi-experimental, pre-posttest, two groups research was carried out at University of Bahrain. A sample of 89 out of 112 pediatric nursing-students were divided into two groups.
METHOD


Through GRPQS, the students mutually generated and responded to questions, activated their critical thinking, elicited ideas, and shared learning experiences within the team and the teachers act as facilitators.
RESULTS


It is revealed that 75% of the students in the study group developed high self-esteem after their engagement in the GRPQS compared to only 48.8% among those in the control one. Students who practiced GRPQS showed an improvement in their knowledge about cognition. As the mean score of students in the study group is increased from 2.16 ± 0.45 to 2.89 + 0.35 for the procedural knowledge, from 2.33 ± 0.56 to 2.86 ± 0.41 for declarative and from 2.18 + 0.53 to 3.09 ± 0.29 for the conditional knowledge (p < 0.001 for each). Concerning the regulation of cognition, the mean score of the planning dimension was improved from2.21 ± 0.46 to 3.10 ± 0.31 among the students in the study group. Moreover, it is clear that applying GRPQS in the lectures helped in improving the students' information management strategies, comprehension monitoring, debugging strategies and evaluation (p < 0.001 for each) compared to the control group p = 0.169, p = 0.009, p = 0.117 and 0.887 respectively).
CONCLUSION


The application of GRPQS provided an interactive and engaging learning experience that helped the students to develop the habit of organizing, judging, and summarizing information as well as focusing on the significant portions of the learning materials. Moreover, exchanging questions between the nursing students was effective in enhancing their self-esteem and metacognitive awareness. Hence, incorporating this innovative pedogeological approach in the nursing curricula is recommended.",2021,"Concerning the regulation of cognition, the mean score of the planning dimension was improved from2.21 ± 0.46 to 3.10 ± 0.31 among the students in the study group.","[""pediatric nursing students' self-esteem and metacognitive awareness"", 'A sample of 89 out of 112 pediatric nursing-students']","['GRPQS', 'guided reciprocal peer questioning strategy']","['self-esteem and metacognitive awareness', 'high self-esteem', 'knowledge about cognition']","[{'cui': 'C0030753', 'cui_str': 'Nursing, Pediatric'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C4046092', 'cui_str': 'Meta-cognitive Awareness'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C4046092', 'cui_str': 'Meta-cognitive Awareness'}, {'cui': 'C2712312', 'cui_str': 'High self-esteem'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",112.0,0.0417207,"Concerning the regulation of cognition, the mean score of the planning dimension was improved from2.21 ± 0.46 to 3.10 ± 0.31 among the students in the study group.","[{'ForeName': 'Zohour Ibrahim', 'Initials': 'ZI', 'LastName': 'Rashwan', 'Affiliation': 'Pediatric Nursing Specialty, Nursing Department, College of Health and Sport Sciences, University of Bahrain, Zallaq, Bahrain; Pediatric Nursing Department, Faculty of Nursing, Alexandria University, Egypt. Electronic address: zrashwan@uob.edu.bh.'}, {'ForeName': 'Toqa Jameel', 'Initials': 'TJ', 'LastName': 'Busebaia', 'Affiliation': 'Medical-Surgical Nursing Specialty, Nursing Department, College of Health and Sport Sciences, University of Bahrain, Zallaq, Bahrain.'}, {'ForeName': 'Amal Saad', 'Initials': 'AS', 'LastName': 'Al-Sabbagh', 'Affiliation': 'Medical-Surgical Nursing Specialty, Nursing Department, College of Health and Sport Sciences, University of Bahrain, Zallaq, Bahrain.'}, {'ForeName': 'Rasha Salah', 'Initials': 'RS', 'LastName': 'Eweida', 'Affiliation': 'Psychiatric Nursing and Mental Health Department, Faculty of Nursing, Alexandria University, Egypt.'}]",Nurse education today,['10.1016/j.nedt.2021.105153']
1727,34563178,Exploring potential mediators of the cardiovascular benefit of dulaglutide in type 2 diabetes patients in REWIND.,"BACKGROUND


The REWIND trial demonstrated cardiovascular (CV) benefits to patients with type 2 diabetes and multiple CV risk factors or established CV disease. This exploratory analysis evaluated the degree to which the effect of dulaglutide on CV risk factors could statistically account for its effects on major adverse cardiovascular events (MACE) in the REWIND trial.
METHODS


Potential mediators of established CV risk factors that were significantly reduced by dulaglutide were assessed in a post hoc analysis using repeated measures mixed models and included glycated hemoglobin (HbA1c), body weight, waist-to-hip ratio, systolic blood pressure, low-density lipoprotein (LDL), and urine albumin/creatinine ratio (UACR). These factors, for which the change in level during follow-up was significantly associated with incident MACE, were identified using Cox regression modeling. Each identified variable was then included as a covariate in the Cox model assessing the effect of dulaglutide on MACE to estimate the degree to which the hazard ratio of dulaglutide vs placebo was attenuated. The combined effect of the variables associated with attenuation was assessed by including all variables in an additional Cox model.
RESULTS


Although all evaluated variables were significantly improved by treatment, only changes in HbA1c and UACR were associated with MACE and a reduction in the effect of dulaglutide on this outcome was observed. The observed hazard ratio for MACE for dulaglutide vs placebo reduced by 36.1% by the updated mean HbA1c, and by 28.5% by the updated mean UACR. A similar pattern was observed for change from baseline in HbA1c and UACR and a reduction of 16.7% and 25.4%, respectively in the hazard ratio for MACE with dulaglutide vs placebo was observed. When HbA1c and UACR were both included, the observed hazard ratio reduced by 65.4% for the updated mean and 41.7% for the change from baseline with no HbA1c-UACR interaction (P interaction = 0.75 and 0.15, respectively).
CONCLUSIONS


Treatment-induced improvement in HbA1c and UACR, but not changes in weight, systolic blood pressure, or LDL cholesterol, appear to partly mediate the beneficial effects of dulaglutide on MACE outcomes. These observations suggest that the proven effects of dulaglutide on cardiovascular disease benefit are partially related to changes in glycemic control and albuminuria, with residual unexplained benefit. Clinicaltrials.gov; Trial registration number: NCT01394952. URL: https://clinicaltrials.gov/ct2/show/NCT01394952.",2021,"CONCLUSIONS


Treatment-induced improvement in HbA1c and UACR, but not changes in weight, systolic blood pressure, or LDL cholesterol, appear to partly mediate the beneficial effects of dulaglutide on MACE outcomes.","['type 2 diabetes patients in REWIND', 'patients with type 2 diabetes and multiple CV risk factors or established CV disease']","['placebo', 'MACE']","['observed hazard ratio', 'weight, systolic blood pressure, or LDL cholesterol', 'HbA1c and UACR', 'glycated hemoglobin (HbA1c), body weight, waist-to-hip ratio, systolic blood pressure, low-density lipoprotein (LDL), and urine albumin/creatinine ratio (UACR', 'observed hazard ratio for MACE']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.197768,"CONCLUSIONS


Treatment-induced improvement in HbA1c and UACR, but not changes in weight, systolic blood pressure, or LDL cholesterol, appear to partly mediate the beneficial effects of dulaglutide on MACE outcomes.","[{'ForeName': 'Manige', 'Initials': 'M', 'LastName': 'Konig', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. konig_manige@lilly.com.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Oregon Health & Science University, Portland, USA.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Kelley R', 'Initials': 'KR', 'LastName': 'Branch', 'Affiliation': 'University of Washington, Seattle, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Atisso', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Mody', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Sohini', 'Initials': 'S', 'LastName': 'Raha', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'McMaster University, Hamilton, ON, Canada.'}]",Cardiovascular diabetology,['10.1186/s12933-021-01386-4']
1728,34562781,The effects of a new seat suspension system on whole body vibration exposure and driver low back pain and disability: Results from a randomized controlled trial in truck drivers.,"Through a randomized controlled trial, we evaluated the effects of an electro-magnetic active seat suspension that reduces exposure of a long-haul truck driver to whole body vibration (WBV) on low back pain (LBP) and disability. Among 276 drivers recruited from six trucking terminals of a major US trucking company, 135 eligible drivers were assigned to either having an Active Seat (Intervention: n = 70) - the BoseRide® electro-magnetic active seat - or Passive Seat (reference: n = 65) - a new version of their current seat (passive air suspension seat) - installed in their truck via block (terminal) randomization. Low back pain (LBP) severity, on a 0-10 scale and the Oswestry LBP Disability Index were collected before and 3-, 6-, 12-, 18-, and 24-months post seat installation. LBP severity and LBP disability scores were significantly lower post seat installation in both groups. At 3 months, LBP severity decreased -1.4 [95% CI: -2.1 to -0.7: n = 46] for drivers in the Active Seat arm, and -1.5 [95% CI: -2.3 to -0.8: n = 41] for drivers in the Passive Seat arm. In a subset of drivers, WBV exposures were collected before and after the seat installation. WBV exposures significantly decreased post seat installation for Active Seat (p < 0.01) but not for Passive Seat (p = 0.15). While the new seat-suspension technology reduced WBV exposures, LBP appeared to be improved by multiple factors. These results were limited by the secondary prevention approach and the longer-term loss to follow up due to large rates of driver turnover typical for the industry.",2022,WBV exposures significantly decreased post seat installation for Active Seat (p < 0.01) but not for Passive Seat (p = 0.15).,"['276 drivers recruited from six trucking terminals of a major US trucking company, 135 eligible drivers']","['having an Active Seat (Intervention: n\xa0=\xa070) - the BoseRide® electro-magnetic active seat - or Passive Seat (reference: n\xa0=\xa065) - a new version of their current seat (passive air suspension seat) - installed in their truck via block (terminal) randomization', 'new seat suspension system', 'electro-magnetic active seat suspension']","['Low back pain (LBP) severity', 'low back pain (LBP) and disability', 'Oswestry LBP Disability Index', 'whole body vibration exposure and driver low back pain and disability', 'LBP severity', 'LBP severity and LBP disability scores']","[{'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4517566', 'cui_str': '135'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",276.0,0.0509167,WBV exposures significantly decreased post seat installation for Active Seat (p < 0.01) but not for Passive Seat (p = 0.15).,"[{'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Dennerlein', 'Affiliation': 'Department of Physical Therapy, Movement, and Rehabilitation Sciences, Bouvé College of Health Sciences, Northeastern University, Boston, MA, USA. Electronic address: j.dennerlein@northeastern.edu.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Cavallari', 'Affiliation': 'Department of Public Health Sciences, University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Jeong Ho Jay', 'Initials': 'JHJ', 'LastName': 'Kim', 'Affiliation': 'Environmental and Occupational Health Program, School of Biological and Population Health Sciences, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Nicholas H', 'Initials': 'NH', 'LastName': 'Green', 'Affiliation': 'Department of Physical Therapy, Movement, and Rehabilitation Sciences, Bouvé College of Health Sciences, Northeastern University, Boston, MA, USA.'}]",Applied ergonomics,['10.1016/j.apergo.2021.103588']
1729,34562648,"The effect of 5-Aminolaevulinic Acid Photodynamic Therapy versus CO 2  laser in the Treatment of Cervical Low-grade Squamous Intraepithelial Lesions with High-Risk HPV Infection: A non-randomized, controlled pilot study.","BACKGROUND


There are insufficient studies comparing the efficacy of 5-aminolaevulinic acid (ALA) photodynamic therapy (PDT) against CO 2  laser therapy in the treatment of cervical low-grade squamous intraepithelial lesion (LSIL) with high-risk human papillomavirus (HR-HPV), especially for long-term efficacy.
METHODS


Patients with cervical LSIL and HR-HPV infection were divided into two treatment groups based on their own choice. All patients had a follow-up test including HPV testing, cytology and colposcopy at 4-6 months and 12 months after the treatment.
RESULTS


(1) Among 277 patients, 176 patients received 5-ALA PDT and 101 patients received CO 2  laser therapy. (2) 4-6 months after treatment, there was no significant difference between two groups in the complete remission (CR) rates of cervical LSIL and the clearance rate of HR-HPV infection. (3) 12 months after treatment, compared with the CO 2  laser group, the CR rates of cervical LSIL in the 5-ALA PDT group was significantly higher than the CO 2  laser group. There was no statistical difference in the clearance rate of HR-HPV infection between the two groups. (4) 12 months after treatment, the recurrence rate of cervical lesions and the reinfection rate of HR-HPV infection in 5-ALA PDT group were significantly lower than those in CO 2  laser group.
CONCLUSION


The effect of 5-ALA PDT is similar to CO 2  laser at 4-6 months. The long-term efficacy of 5-ALA PDT appears better than CO 2  laser. As a non-invasive treatment, 5-ALA PDT is a highly effective therapeutic procedure for cervical LSIL with HR-HPV infection.",2021,"(4) 12 months after treatment, the recurrence rate of cervical lesions and the reinfection rate of HR-HPV infection in 5-ALA PDT group were significantly lower than those in CO 2  laser group.
","['Cervical Low-grade Squamous Intraepithelial Lesions with High-Risk HPV Infection', 'Patients with cervical LSIL and HR-HPV infection', '277 patients, 176 patients received', 'cervical low-grade squamous intraepithelial lesion (LSIL) with high-risk human papillomavirus (HR-HPV']","['5-ALA PDT', '5-Aminolaevulinic Acid Photodynamic Therapy versus CO 2  laser', 'CO 2  laser therapy', '5-aminolaevulinic acid (ALA) photodynamic therapy (PDT) and CO 2  laser therapy']","['recurrence rate of cervical lesions and the reinfection rate of HR-HPV infection', 'complete remission (CR) rates of cervical LSIL and the clearance rate of HR-HPV infection', 'CR rates of cervical LSIL', 'clearance rate of HR-HPV infection', 'HPV testing, cytology and colposcopy']","[{'cui': 'C1518005', 'cui_str': 'Cervical low grade squamous intraepithelial lesion'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1302773', 'cui_str': 'Squamous intraepithelial neoplasia, low grade'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]","[{'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0235656', 'cui_str': 'Lesion of cervix'}, {'cui': 'C0205339', 'cui_str': 'Reinfection'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1302773', 'cui_str': 'Squamous intraepithelial neoplasia, low grade'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0009417', 'cui_str': 'Colposcopy'}]",277.0,0.0266857,"(4) 12 months after treatment, the recurrence rate of cervical lesions and the reinfection rate of HR-HPV infection in 5-ALA PDT group were significantly lower than those in CO 2  laser group.
","[{'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Department of Obstetrics and Gynecology, Renji Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Key Laboratory of Gynecologic Oncology, Renji Hospital, Shanghai Jiaotong University School of Medicine.'}, {'ForeName': 'Mengxing', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': 'Department of Obstetrics and Gynecology, Renji Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Key Laboratory of Gynecologic Oncology, Renji Hospital, Shanghai Jiaotong University School of Medicine.'}, {'ForeName': 'Zubei', 'Initials': 'Z', 'LastName': 'Hong', 'Affiliation': 'Department of Obstetrics and Gynecology, Renji Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Key Laboratory of Gynecologic Oncology, Renji Hospital, Shanghai Jiaotong University School of Medicine.'}, {'ForeName': 'Jiayan', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'Department of Obstetrics and Gynecology, Renji Hospital, Shanghai Jiaotong University School of Medicine.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Di', 'Affiliation': 'Department of Obstetrics and Gynecology, Renji Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Key Laboratory of Gynecologic Oncology, Renji Hospital, Shanghai Jiaotong University School of Medicine; State Key Laboratory of Oncogenes and Related Genes, Shanghai Cancer Institute, Renji Hospital, Shanghai Jiaotong University School of Medicine.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Department of Obstetrics and Gynecology, Renji Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Key Laboratory of Gynecologic Oncology, Renji Hospital, Shanghai Jiaotong University School of Medicine. Electronic address: guliying_obgyn@hotmail.com.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'Department of Obstetrics and Gynecology, Renji Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Key Laboratory of Gynecologic Oncology, Renji Hospital, Shanghai Jiaotong University School of Medicine; State Key Laboratory of Oncogenes and Related Genes, Shanghai Cancer Institute, Renji Hospital, Shanghai Jiaotong University School of Medicine. Electronic address: lilyqiulh@126.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102548']
1730,34555068,Effects of specific inspiratory muscle training combined with whole-body endurance training program on balance in COPD patients: Randomized controlled trial.,"PURPOSE


This study aims to assess the effect of inspiratory muscle training (IMT) combined with endurance training (ET) on balance in patients with chronic obstructive pulmonary disease (COPD).
METHODS


We studied 32 male patients (62 ± 6 years) with moderate to very severe COPD. They were randomly assigned to an experimental group (IMT+ET) n = 16 or a control group (ET) n = 16 with similar characteristics. The evaluations were carried out at inclusion and after eight weeks of the training period. Functional balance was assessed by the Berg Balance Scale (BBS), the Timed-up and Go (TUG), the Single Leg Stance test (SLS), and the Activities-specific Balance Confidence (ABC) scale. The strength of the inspiratory muscles (PImax) was assessed by maximal inspiratory mouth pressure. Functional exercise performance was assessed by the 6 minutes walking test (6MWT). IMT program consists in performing two daily sets of 30 inspirations with 50% of PImax increased by 10% every two weeks. ET program consists in performing 30 min treadmill exercise at 60% to 80% of the average speed achieved during the 6MWT three days per week.
RESULTS


After the training period, the experimental group demonstrated greater improvements in BBS (IMT+ET vs. ET; p = 0.019), and in ABC (IMT+ET vs. ET; p = 0.014). However, no significant differences between groups were observed for TUG, SLS, and 6MWT. There was a significant difference between groups in PImax (IMT+ET vs. ET; p = 0.030). Significant moderate correlations were obtained between ΔPImax and ΔBBS for both groups (IMT+ET: r = 0.624, p = 0.010; ET r = 0.550, p = 0.027) as well as for ΔABC but only in the experimental group (IMT+ET: r = 0.550, p = 0.027).
CONCLUSION


Compared to ET alone, the results suggest that IMT combined with ET enhances inspiratory muscle function and functional balance according to BBS and ABC in patients with COPD. We suggest that inspiratory muscle training might be introduced as additional training to pulmonary rehabilitation programs aimed at improving balance in COPD patients.
TRIAL REGISTRATION


The trial registry name: Clinical Trials; Registration number: NCT04084405; URL: https://clinicaltrials.gov/ct2/show/NCT04084405.",2021,There was a significant difference between groups in PImax (IMT+ET vs. ET; p = 0.030).,"['patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', '32 male patients (62 ± 6 years) with moderate to very severe COPD', 'COPD patients']","['inspiratory muscle training', 'inspiratory muscle training (IMT) combined with endurance training (ET', 'IMT combined with ET', 'specific inspiratory muscle training combined with whole-body endurance training program']","['inspiratory muscle function and functional balance', 'Functional exercise performance', 'strength of the inspiratory muscles (PImax', 'TUG, SLS, and 6MWT', 'BBS', 'Berg Balance Scale (BBS), the Timed-up and Go (TUG), the Single Leg Stance test (SLS), and the Activities-specific Balance Confidence (ABC) scale', 'Functional balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",32.0,0.0202362,There was a significant difference between groups in PImax (IMT+ET vs. ET; p = 0.030).,"[{'ForeName': 'Bilel', 'Initials': 'B', 'LastName': 'Tounsi', 'Affiliation': 'Laboratory of Exercise Physiology and Rehabilitation (APERE, UR-EA 3300), Sport Sciences Department, Picardie Jules Verne University, Amiens, France.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Acheche', 'Affiliation': 'Research Laboratory of Exercise Physiology and Pathophysiology: From Integral to Molecular Biology, Medicine and Health (LR19ES09), Faculty of Medicine of Sousse, University of Sousse, Sousse, Tunisia.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lelard', 'Affiliation': 'Laboratory of Exercise Physiology and Rehabilitation (APERE, UR-EA 3300), Sport Sciences Department, Picardie Jules Verne University, Amiens, France.'}, {'ForeName': 'Zouhair', 'Initials': 'Z', 'LastName': 'Tabka', 'Affiliation': 'Research Laboratory of Exercise Physiology and Pathophysiology: From Integral to Molecular Biology, Medicine and Health (LR19ES09), Faculty of Medicine of Sousse, University of Sousse, Sousse, Tunisia.'}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Trabelsi', 'Affiliation': 'Research Laboratory of Exercise Physiology and Pathophysiology: From Integral to Molecular Biology, Medicine and Health (LR19ES09), Faculty of Medicine of Sousse, University of Sousse, Sousse, Tunisia.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Ahmaidi', 'Affiliation': 'Laboratory of Exercise Physiology and Rehabilitation (APERE, UR-EA 3300), Sport Sciences Department, Picardie Jules Verne University, Amiens, France.'}]",PloS one,['10.1371/journal.pone.0257595']
1731,34555050,Parenting and childhood obesity: Validation of a new questionnaire and evaluation of treatment effects during the preschool years.,"OBJECTIVES


Parenting is an integral component of obesity treatment in early childhood. However, the link between specific parenting practices and treatment effectiveness remains unclear. This paper introduces and validates a new parenting questionnaire and evaluates mothers' and fathers' parenting practices in relation to child weight status during a 12-month childhood obesity treatment trial.
METHODS


First, a merged school/clinical sample (n = 558, 82% mothers) was used for the factorial and construct validation of the new parenting questionnaire. Second, changes in parenting were evaluated using clinical data from the More and Less Study, a randomized controlled trial (RCT) with 174 children (mean age = 5 years, mean Body Mass Index Standard Deviation Score (BMI SDS) = 3.0) comparing a parent support program (with and without booster sessions) and standard treatment. Data were collected at four time points over 12 months. We used linear mixed models and mediation models to investigate associations between changes in parenting practices and treatment effects.
FINDINGS


The validation of the questionnaire (9 items; responses on a 5-point Likert scale) revealed two dimensions of parenting (Cronbach's alpha ≥0.7): setting limits to the child and regulating one's own emotions when interacting with the child, both of which correlated with feeding practices and parental self-efficacy. We administered the questionnaire to the RCT participants. Fathers in standard treatment increased their emotional regulation compared to fathers in the parenting program (p = 0.03). Mothers increased their limit-setting regardless of treatment allocation (p = 0.01). No treatment effect was found on child weight status through changes in parenting practices.
CONCLUSION


Taken together, the findings demonstrate that the new questionnaire assessing parenting practices proved valid in a 12-month childhood obesity trial. During treatment, paternal and maternal parenting practices followed different trajectories, though they did not mediate treatment effects on child weight status. Future research should address the pathways whereby maternal and paternal parenting practices affect treatment outcomes, such as child eating behaviors and weight status.",2021,"During treatment, paternal and maternal parenting practices followed different trajectories, though they did not mediate treatment effects on child weight status.","['174 children (mean age = 5 years', 'early childhood']",[],"['child weight status', 'mean Body Mass Index Standard Deviation Score', 'emotional regulation']","[{'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.026042,"During treatment, paternal and maternal parenting practices followed different trajectories, though they did not mediate treatment effects on child weight status.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Somaraki', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ek', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Eli', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Ljung', 'Affiliation': 'Aleris Rehab, Skärholmen, Sweden.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mildton', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Sandvik', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Nowicka', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden.'}]",PloS one,['10.1371/journal.pone.0257187']
1732,34555048,"Effect of advanced periodontal self-care in patients with early-stage periodontal diseases on endothelial function: An open-label, randomized controlled trial.","Although a significant association between periodontal disease and atherosclerotic cardiovascular disease has been reported, their cause-to-effect relationship remains controversial. This randomized controlled clinical trial aimed to investigate the effect of advanced self-care on atherosclerotic cardiovascular disease-related vascular function markers flow-mediated brachial artery dilatation (FMD) and serum asymmetric dimethylarginine (ADMA) level in patients with early-stage periodontal disease. The study was designed as a parallel group, 3-month follow-up, open-label, randomized controlled trial. The control group received standard care for periodontal diseases, whereas the test group additionally applied disinfectant using a custom-fabricated prescription tray for advanced self-care twice a day. Overall, 110 patients provided data for FMD and serum ADMA level. No significant improvements in FMD were observed in the control (mean increase, -0.1%; 95% confidence interval [CI], -1.0-0.8; P = 0.805) or test (mean increase, -0.3%; 95% CI, -1.1-0.4; P = 0.398) group. No significant changes in serum ADMA levels were observed (mean reduction, 0.01 μmol/L; 95% CI, -0.00-0.02; P = 0.366 and mean reduction, 0.00 μmol/L; 95% CI, -0.01-0.01; P = 0.349, respectively). No significant between-group differences were found in FMD (mean difference, -0.2%; 95% CI, -1.4-0.9; p = 0.708) or serum ADMA levels (mean difference, 0.01 nmol/L; 95% CI, -0.00-0.03; p = 0.122). Significant improvements in the average probing pocket depth were observed in the control and test groups. The bleeding on probing score in the test group was significantly reduced, while that in the control group was reduced, although not significantly. Periodontal care for a 3-month duration did not provide better endothelial function although improvements of periodontal status in patients with early-stage periodontal diseases. This trial is registered in UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/; ID: UMIN000023395).",2021,Periodontal care for a 3-month duration did not provide better endothelial function although improvements of periodontal status in patients with early-stage periodontal diseases.,"['patients with early-stage periodontal diseases on endothelial function', 'patients with early-stage periodontal diseases', 'patients with early-stage periodontal disease']","['advanced periodontal self-care', 'advanced self-care', 'standard care for periodontal diseases, whereas the test group additionally applied disinfectant using a custom-fabricated prescription tray']","['bleeding on probing score', 'serum ADMA levels', 'FMD and serum ADMA level', 'average probing pocket depth', 'FMD', 'atherosclerotic cardiovascular disease-related vascular function markers flow-mediated brachial artery dilatation (FMD) and serum asymmetric dimethylarginine (ADMA) level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0184054', 'cui_str': 'Tray'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",110.0,0.176024,Periodontal care for a 3-month duration did not provide better endothelial function although improvements of periodontal status in patients with early-stage periodontal diseases.,"[{'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Okada', 'Affiliation': 'Department of Translational Research, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Murata', 'Affiliation': 'Department of Translational Research, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}, {'ForeName': 'Khairul', 'Initials': 'K', 'LastName': 'Matin', 'Affiliation': 'Endowed Department of International Oral Health Science, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}, {'ForeName': 'Meu', 'Initials': 'M', 'LastName': 'Ariyoshi', 'Affiliation': 'Department of Translational Research, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Otsuka', 'Affiliation': 'Department of Translational Research, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}, {'ForeName': 'Mamiko', 'Initials': 'M', 'LastName': 'Yamashita', 'Affiliation': 'Department of Translational Research, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Dental Anesthesiology, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}, {'ForeName': 'Rumi', 'Initials': 'R', 'LastName': 'Wakiyama', 'Affiliation': 'Department of Dental Anesthesiology, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Tateno', 'Affiliation': 'Department of Dental Anesthesiology, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Dental Hygiene, The Nippon Dental University College at Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Aoyagi', 'Affiliation': 'The Nippon Dental University Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Uematsu', 'Affiliation': 'The Nippon Dental University Hospital, Tokyo, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Imamura', 'Affiliation': 'The Nippon Dental University Hospital, Tokyo, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Kosaka', 'Affiliation': 'Department of Translational Research, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Mizukaki', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, St. Marianna University School of Medicine Kawasaki Municipal Tama Hospital, Kawasaki, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Division of Basic Medical Science, Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawahara', 'Affiliation': 'Department of Dental Anesthesiology, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Hanada', 'Affiliation': 'Department of Translational Research, Tsurumi University School of Dental Medicine, Yokohama, Japan.'}]",PloS one,['10.1371/journal.pone.0257247']
1733,34555043,Opioid-free anesthesia compared to opioid anesthesia for lung cancer patients undergoing video-assisted thoracoscopic surgery: A randomized controlled study.,"BACKGROUND


Reducing intra-operative opioid consumption benefits patients by decreasing postoperative opioid-related adverse events. We assessed whether opioid-free anesthesia would provide effective analgesia-antinociception monitored by analgesia index in video-assisted thoracoscopic surgery.
METHODS


Patients (ASA Ⅰ-Ⅱ, 18-65 years old, BMI <30 kg m-2) scheduled to undergo video-assisted thoracoscopic surgery under general anesthesia were randomly allocated into two groups to receive opioid-free anesthesia (group OFA) with dexmedetomidine, sevoflurane plus thoracic paravertebral blockade or opioid-based anesthesia (group OA) with remifentanil, sevoflurane, and thoracic paravertebral blockade. The primary outcome variable was pain intensity during the operation, assessed by the depth of analgesia using the pain threshold index with the multifunction combination monitor HXD‑I. Secondary outcomes included depth of sedation monitoring by wavelet index and blood glucose concentration achieved from blood gas.
RESULTS


One hundred patients were randomized; 3 patients were excluded due to discontinued intervention and 97 included in the final analysis. Intraoperative pain threshold index readings were not significantly different between group OFA and group OA from arriving operation room to extubation (P = 0.86), while the brain wavelet index readings in group OFA were notably lower than those in group OA from before general anesthesia induction to recovery of double lungs ventilation (P <0.001). After beginning of operation, the blood glucose levels in group OFA increased compared with baseline blood glucose values (P < 0.001). The recovery time and extubation time in group OFA were significantly longer than those in group OA (P <0.007).
CONCLUSIONS


This study suggested that our OFA regimen achieved equally effective intraoperative pain threshold index compared to OA in video-assisted thoracoscopic surgery. Depth of sedation was significantly deeper and blood glucose levels were higher with OFA. Study's limitations and strict inclusion criteria may limit the external validity of the study, suggesting the need of further randomized trials on the topic. Trial registration: ChiCTR1800019479, Title: ""Opioid-free anesthesia in video-assisted thoracoscopic surgery lobectomy"".",2021,"Intraoperative pain threshold index readings were not significantly different between group OFA and group OA from arriving operation room to extubation (P = 0.86), while the brain wavelet index readings in group OFA were notably lower than those in group OA from before general anesthesia induction to recovery of double lungs ventilation (P <0.001).","['One hundred patients were randomized; 3 patients were excluded due to discontinued intervention and 97 included in the final analysis', 'Patients (ASA Ⅰ-Ⅱ, 18-65 years old, BMI <30 kg m-2) scheduled to undergo video-assisted thoracoscopic surgery under general anesthesia', 'lung cancer patients undergoing']","['Opioid-free anesthesia', 'video-assisted thoracoscopic surgery', 'opioid anesthesia', 'dexmedetomidine, sevoflurane plus thoracic paravertebral blockade or opioid-based anesthesia (group OA) with remifentanil, sevoflurane, and thoracic paravertebral blockade', 'opioid-free anesthesia', 'Opioid-free anesthesia in video-assisted thoracoscopic surgery lobectomy']","['brain wavelet index readings', 'recovery time and extubation time', 'pain intensity during the operation, assessed by the depth of analgesia using the pain threshold index with the multifunction combination monitor', 'blood glucose levels', 'Depth of sedation', 'Intraoperative pain threshold index readings', 'depth of sedation monitoring by wavelet index and blood glucose concentration achieved from blood gas']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C4520228', 'cui_str': 'Thoracoscopic surgical lobectomy using video-assisted guidance'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}]",100.0,0.111666,"Intraoperative pain threshold index readings were not significantly different between group OFA and group OA from arriving operation room to extubation (P = 0.86), while the brain wavelet index readings in group OFA were notably lower than those in group OA from before general anesthesia induction to recovery of double lungs ventilation (P <0.001).","[{'ForeName': 'Guangquan', 'Initials': 'G', 'LastName': 'An', 'Affiliation': 'Department of Second Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesia, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China.'}, {'ForeName': 'Nuoya', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesia, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Department of Anesthesia, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China.'}, {'ForeName': 'Bingsha', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesia, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesia, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China.'}]",PloS one,['10.1371/journal.pone.0257279']
1734,34555031,A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumab.,"PURPOSE


This first-in-human study was designed to evaluate the pharmacokinetic (PK) equivalence between HD204 and the European Union (EU)-sourced bevacizumab, between HD204 and the United States of America (US)-sourced bevacizumab, and between EU-sourced and US-sourced bevacizumab (NCT03390673).
METHODS


In this randomized, double-blind, 3-way parallel group, single-dose comparative PK study, healthy male subjects were randomized to receive a single 1 mg/kg intravenous dose of HD204, EU-sourced bevacizumab or US-sourced bevacizumab. PK parameters were calculated using non-compartmental methods. PK equivalence was determined using the pre-defined equivalence margin of 0.8-1.25 in terms of AUC(0-∞) for the pairwise comparisons.
FINDINGS


Baseline demographics for the 119 randomized subjects were similar across the three groups. The 90% CIs for the ratio of the geometric means of HD204 to US-sourced bevacizumab, HD204 to EU-sourced bevacizumab, and EU-sourced to US-sourced bevacizumab were all within the interval of 80% to 125% for AUC0-inf, thus demonstrating equivalency in the PK properties for all three treatment groups. Similarly, the ratio of the geometric means for AUC0-last and Cmax were all within the 80% and 125% margins, supporting the robustness of the primary findings. All other PK parameters, including the half-life (t1⁄2) clearance (CL), volume of distribution (Vd) and time of maximum concentration (tmax), were comparable. There was no difference between the 3 treatment arms in terms of vital signs, laboratory tests and adverse events. None of the subjects treated with HD204 had positive ADA results.
IMPLICATIONS


HD204 demonstrates equivalent pharmacokinetic profiles compared to those of both US-sourced and EU-sourced bevacizumab. (NCT03390673).",2021,"There was no difference between the 3 treatment arms in terms of vital signs, laboratory tests and adverse events.",['healthy male subjects'],"['bevacizumab (HD204) biosimilar', 'bevacizumab', 'European Union (EU)-sourced bevacizumab, between HD204 and the United States of America (US)-sourced bevacizumab, and between EU-sourced and US-sourced bevacizumab', 'HD204, EU-sourced bevacizumab or US-sourced bevacizumab']","['PK equivalence', 'ratio of the geometric means for AUC0-last and Cmax', 'pharmacokinetic (PK) equivalence', 'half-life (t1⁄2) clearance (CL), volume of distribution (Vd) and time of maximum concentration (tmax', 'vital signs, laboratory tests and adverse events', 'PK parameters']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002454', 'cui_str': 'America'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.109334,"There was no difference between the 3 treatment arms in terms of vital signs, laboratory tests and adverse events.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Demarchi', 'Affiliation': 'Paul Strauss Center, Strasbourg, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Coliat', 'Affiliation': 'Institut Cancérologie de Strasbourg (ICANS), Strasbourg, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthelemy', 'Affiliation': 'Institut Cancérologie de Strasbourg (ICANS), Strasbourg, France.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Schott', 'Affiliation': 'Paul Strauss Center, Strasbourg, France.'}, {'ForeName': 'Meher', 'Initials': 'M', 'LastName': 'BenAbdelghani', 'Affiliation': 'Paul Strauss Center, Strasbourg, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Prestige BioPharma Ltd, Singapore, Singapore.'}, {'ForeName': 'Jocelyn Chung Shii', 'Initials': 'JCS', 'LastName': 'Hii', 'Affiliation': 'Prestige BioPharma Ltd, Singapore, Singapore.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Feyaerts', 'Affiliation': 'Prestige BioPharma Ltd, Singapore, Singapore.'}, {'ForeName': 'Felicia Rui Xia', 'Initials': 'FRX', 'LastName': 'Ang', 'Affiliation': 'Prestige BioPharma Ltd, Singapore, Singapore.'}, {'ForeName': 'Marie Paule', 'Initials': 'MP', 'LastName': 'Derde', 'Affiliation': 'DICE Cro bvba, Brussels, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Deforce', 'Affiliation': 'DICE Cro bvba, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Petit', 'Affiliation': 'Paul Strauss Center, Strasbourg, France.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Schwabe', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wynne', 'Affiliation': 'Christchurch Clinical Studies Trust Ltd, Christchurch, New Zealand.'}, {'ForeName': 'Lisa Soyeon', 'Initials': 'LS', 'LastName': 'Park', 'Affiliation': 'Prestige BioPharma Ltd, Singapore, Singapore.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pivot', 'Affiliation': 'Institut Cancérologie de Strasbourg (ICANS), Strasbourg, France.'}]",PloS one,['10.1371/journal.pone.0248222']
1735,34551811,Study protocol for a type III hybrid effectiveness-implementation trial of strategies to implement firearm safety promotion as a universal suicide prevention strategy in pediatric primary care.,"BACKGROUND


Insights from behavioral economics, or how individuals' decisions and behaviors are shaped by finite cognitive resources (e.g., time, attention) and mental heuristics, have been underutilized in efforts to increase the use of evidence-based practices in implementation science. Using the example of firearm safety promotion in pediatric primary care, which addresses an evidence-to-practice gap in universal suicide prevention, we aim to determine: is a less costly and more scalable behavioral economic-informed implementation strategy (i.e., ""Nudge"") powerful enough to change clinician behavior or is a more intensive and expensive facilitation strategy needed to overcome implementation barriers?
METHODS


The Adolescent and child Suicide Prevention in Routine clinical Encounters (ASPIRE) hybrid type III effectiveness-implementation trial uses a longitudinal cluster randomized design. We will test the comparative effectiveness of two implementation strategies to support clinicians' use of an evidence-based firearm safety practice, S.A.F.E. Firearm, in 32 pediatric practices across two health systems. All pediatric practices in the two health systems will receive S.A.F.E. Firearm materials, including training and cable locks. Half of the practices (k = 16) will be randomized to receive Nudge; the other half (k = 16) will be randomized to receive Nudge plus 1 year of facilitation to target additional practice and clinician implementation barriers (Nudge+). The primary implementation outcome is parent-reported clinician fidelity to the S.A.F.E Firearm program. Secondary implementation outcomes include reach and cost. To understand how the implementation strategies work, the primary mechanism to be tested is practice adaptive reserve, a self-report practice-level measure that includes relationship infrastructure, facilitative leadership, sense-making, teamwork, work environment, and culture of learning.
DISCUSSION


The ASPIRE trial will integrate implementation science and behavioral economic approaches to advance our understanding of methods for implementing evidence-based firearm safety promotion practices in pediatric primary care. The study answers a question at the heart of many practice change efforts: which strategies are sufficient to support change, and why? Results of the trial will offer valuable insights into how best to implement evidence-based practices that address sensitive health matters in pediatric primary care.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04844021 . Registered 14 April 2021.",2021,"We will test the comparative effectiveness of two implementation strategies to support clinicians' use of an evidence-based firearm safety practice, S.A.F.E. Firearm, in 32 pediatric practices across two health systems.","['32 pediatric practices across two health systems', 'pediatric primary care']",['Nudge plus 1 year of facilitation to target additional practice and clinician implementation barriers (Nudge'],"['parent-reported clinician fidelity to the S.A.F.E Firearm program', 'reach and cost']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0016139', 'cui_str': 'Firearm'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0770094,"We will test the comparative effectiveness of two implementation strategies to support clinicians' use of an evidence-based firearm safety practice, S.A.F.E. Firearm, in 32 pediatric practices across two health systems.","[{'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. rinad.beidas@pennmedicine.upenn.edu.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Ahmedani', 'Affiliation': 'Center for Health Policy and Health Services Research, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Linn', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Marcus', 'Affiliation': 'School of Social Policy and Practice, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Maye', 'Affiliation': 'Center for Health Policy and Health Services Research, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Joslyn', 'Initials': 'J', 'LastName': 'Westphal', 'Affiliation': 'Center for Health Policy and Health Services Research, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'Arne L', 'Initials': 'AL', 'LastName': 'Beck', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Buttenheim', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Daley', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marisa E', 'Initials': 'ME', 'LastName': 'Elias', 'Affiliation': 'Department of Pediatrics, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Jager-Hyman', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Katelin', 'Initials': 'K', 'LastName': 'Hoskins', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Adina', 'Initials': 'A', 'LastName': 'Lieberman', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'McArdle', 'Affiliation': 'Department of Pediatrics, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Debra P', 'Initials': 'DP', 'LastName': 'Ritzwoller', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Wharton School of Business, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Courtney Benjamin', 'Initials': 'CB', 'LastName': 'Wolk', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Nathaniel J', 'Initials': 'NJ', 'LastName': 'Williams', 'Affiliation': 'School of Social Work, Boise State University, Boise, ID, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Boggs', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}]",Implementation science : IS,['10.1186/s13012-021-01154-8']
1736,34592639,"Low-dose ketamine infusion for treating subjective cognitive, somatic, and affective depression symptoms of treatment-resistant depression.","BACKGROUNDS


Whether the antidepressant effects of low-dose ketamine infusion and the therapeutic impact of Val66Met brain-derived neurotrophic factor (BDNF) polymorphism vary across different depression symptom domains, namely affective, cognitive, and somatic, remains unclear.
METHODS


We-reanalyzed the data of Adjunctive Ketamine Study of Taiwanese Patients with Treatment-Resistant Depression (TRD). A total of 71 patients with TRD were randomized to three infusion groups: 0.5 and 0.2 mg/kg ketamine groups and the normal saline placebo group. The Beck Depression Inventory-II (BDI-II) was used to obtain self-reported scores prior to infusion and 240 min after infusion and sequentially on days 3, 7, and 14 after infusion. The three-factor model of cognitive, somatic, and affective depressive symptoms that is based on the BDI-II and proposed by Beck et al. was applied in the current study. The Val66Met BDNF polymorphism was genotyped.
RESULTS


Ketamine infusion exerted rapid and sustained antidepressant effects on the affective (p = 0.014) and cognitive (p = 0.005) depression symptom domains but not on the somatic (p = 0.085) depression symptom domain. Only patients with TRD harboring any Val allele at the BDNF rs6265 polymorphism were more likely to respond (p = 0.011) to low-dose ketamine infusion.
DISCUSSION


Additional studies should elucidate different mechanisms underlying the effects of ketamine infusion on cognitive, affective, and somatic depression symptom domains in patients with TRD.",2021,"RESULTS


Ketamine infusion exerted rapid and sustained antidepressant effects on the affective (p = 0.014) and cognitive (p = 0.005) depression symptom domains but not on the somatic (p = 0.085) depression symptom domain.","['71 patients with TRD', 'patients with TRD', 'Taiwanese Patients with Treatment-Resistant Depression (TRD']","['ketamine groups and the normal saline placebo', 'Ketamine', 'ketamine']",['Beck Depression Inventory-II (BDI-II'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",71.0,0.0764787,"RESULTS


Ketamine infusion exerted rapid and sustained antidepressant effects on the affective (p = 0.014) and cognitive (p = 0.005) depression symptom domains but not on the somatic (p = 0.085) depression symptom domain.","[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan. Electronic address: kremer7119@gmail.com.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Medical Research, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chung', 'Initials': 'WC', 'LastName': 'Mao', 'Affiliation': 'Department of Psychiatry, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Medical Research, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Psychiatry, Cheng Hsin General Hospital, Taipei, Taiwan. Electronic address: tomsu0402@gmail.com.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2021.102869']
1737,34592609,The effect of concreteness training on peri-traumatic processing and intrusive memories following an analogue trauma.,"High levels of rumination are a risk factor for developing posttraumatic stress disorder (PTSD). Theoretical models of rumination as well as earlier empirical findings suggest that the dysfunctional effects of rumination are due to an abstract processing style, and that a more concrete style of thinking has beneficial effects on mental well-being. The present study therefore examined whether concreteness training prior to watching a trauma film prevents analogue PTSD symptoms in the form of intrusive memories. Healthy participants either received concreteness training or were allocated to a no-intervention control condition, and watched a distressing film three days later. We examined differences in intrusive memories related to the film scenes between conditions, and tested whether concreteness training reduces the link between trait rumination and analogue PTSD symptoms. Furthermore, the interacting effect of concreteness training and trait rumination on peri-traumatic processing was investigated. In line with the hypotheses, concreteness training was associated with less frequent intrusive memories and moderated the association between trait rumination and intrusive memories as well as trait rumination and dissociation during the film. These findings lend support to the hypothesis that processing style contributes to the negative impact of rumination on posttraumatic stress symptoms. In addition, they provide preliminary evidence that concreteness training may be a promising intervention for the prevention of PTSD following trauma.",2021,"In line with the hypotheses, concreteness training was associated with less frequent intrusive memories and moderated the association between trait rumination and intrusive memories as well as trait rumination and dissociation during the film.",['Healthy participants either received'],"['concreteness training and trait rumination', 'concreteness training prior to watching a trauma film', 'concreteness training', 'concreteness training or were allocated to a no-intervention control condition, and watched a distressing film three days later']","['frequent intrusive memories', 'peri-traumatic processing and intrusive memories', 'trait rumination and dissociation', 'trait rumination and intrusive memories', 'trait rumination and analogue PTSD symptoms']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0129901,"In line with the hypotheses, concreteness training was associated with less frequent intrusive memories and moderated the association between trait rumination and intrusive memories as well as trait rumination and dissociation during the film.","[{'ForeName': 'Melike', 'Initials': 'M', 'LastName': 'Guzey', 'Affiliation': 'Ankara University, Department of Psychology, Turkey. Electronic address: melikeguzey@gmail.com.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Funk', 'Affiliation': 'LMU Munich, Department of Psychology, Germany. Electronic address: jul.funk@psy.lmu.de.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kustermann', 'Affiliation': 'LMU Munich, Department of Psychology, Germany. Electronic address: juli-kustermann@web.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ehring', 'Affiliation': 'LMU Munich, Department of Psychology, Germany. Electronic address: thomas.ehring@lmu.de.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103970']
1738,34592421,Association of autonomic function and brain activity with personality traits by paced breathing and su-soku practice: A three-way crossover study.,"OBJECTIVES


This study aimed to compare the effectiveness of paced breathing (PB) versus su-soku practice (spontaneous breathing with counting numbers) on autonomic function and brain activity and examine the associations between personality traits, brain activity, and autonomic function.
DESIGN


A three-way crossover study design.
SETTING


Thirty healthy Korean participants (15 men: 28.5 ± 4.7 years; 15 women: 27.7 ± 4.8 years) were asked to answer the Korean version of the 125-Temperament and Character Inventory (TCI). Three-way crossover design included normal PB (0.25 Hz), slow PB (0.1 Hz), and su-soku practice. Participants were randomly assigned to one of three groups (group A: su-soku/normal PB/slow PB; group B: normal PB/slow PB/su-soku; group C: slow PB/su-soku/normal PB).
MAIN OUTCOME MEASURES


The Korean version of the 125-TCI scores, electroencephalography (EEG), heart rate variability (HRV), and respiratory curve data.
RESULTS


EEG parameters between normal PB, slow PB, and su-soku showed no significant differences. High frequency and approximate entropy during normal PB and su-soku were higher than those during slow PB. Alpha band power related to well-focused alertness had strong negative correlations with the standard deviation of R-R intervals and square root of the mean of the sum of the squares of differences between adjacent R-R intervals during su-soku practice, while theta band power related to drowsiness had strong positive correlations with very low-frequency power during normal PB. Reflective and analytical individuals tended to be highly focused and alert during su-soku and normal PB, while anxious and unwilling individuals tended to focus on counting in and be drowsier during normal PB.
CONCLUSIONS


This study's findings suggest that the association between brain activity and autonomic function is affected by meditation type and personality traits.",2021,"Alpha band power related to well-focused alertness had strong negative correlations with the standard deviation of R-R intervals and square root of the mean of the sum of the squares of differences between adjacent R-R intervals during su-soku practice, while theta band power related to drowsiness had strong positive correlations with very low-frequency power during normal PB.",['Thirty healthy Korean participants (15 men: 28.5±4.7 years; 15 women: 27.7±4.8 years'],"['paced breathing and su-soku practice', 'su-soku/normal PB/slow PB; group B: normal PB/slow PB/su-soku; group C: slow PB/su-soku/normal PB', 'paced breathing (PB) versus su-soku practice (spontaneous breathing with counting numbers']","['personality traits, brain activity, and autonomic function', '125-TCI scores, electroencephalography (EEG), heart rate variability (HRV), and respiratory curve data', 'normal PB (0.25Hz), slow PB (0.1Hz), and su-soku practice', 'autonomic function and brain activity', 'brain activity and autonomic function']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0233849', 'cui_str': 'Character trait finding'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]",30.0,0.0394904,"Alpha band power related to well-focused alertness had strong negative correlations with the standard deviation of R-R intervals and square root of the mean of the sum of the squares of differences between adjacent R-R intervals during su-soku practice, while theta band power related to drowsiness had strong positive correlations with very low-frequency power during normal PB.","[{'ForeName': 'Young-Jae', 'Initials': 'YJ', 'LastName': 'Park', 'Affiliation': 'Department of Biofunctional Medicine and Diagnostics, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea; Department of Diagnosis and Biofunctional Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea. Electronic address: bmpomd@khu.ac.kr.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102778']
1739,34596572,A Digital Human for Delivering a Remote Loneliness and Stress Intervention to At-Risk Younger and Older Adults During the COVID-19 Pandemic: Randomized Pilot Trial.,"BACKGROUND


Loneliness is a growing public health issue that has been exacerbated in vulnerable groups during the COVID-19 pandemic. Computer agents are capable of delivering psychological therapies through the internet; however, there is limited research on their acceptability to date.
OBJECTIVE


The objectives of this study were to evaluate (1) the feasibility and acceptability of a remote loneliness and stress intervention with digital human delivery to at-risk adults and (2) the feasibility of the study methods in preparation for a randomized controlled trial.
METHODS


A parallel randomized pilot trial with a mixed design was conducted. Participants were adults aged 18 to 69 years with an underlying medical condition or aged 70 years or older with a Mini-Mental State Examination score of >24 (ie, at greater risk of developing severe COVID-19). Participants took part from their place of residence (independent living retirement village, 20; community dwelling, 7; nursing home, 3). Participants were randomly allocated to the intervention or waitlist control group that received the intervention 1 week later. The intervention involved completing cognitive behavioral and positive psychology exercises with a digital human facilitator on a website for at least 15 minutes per day over 1 week. The exercises targeted loneliness, stress, and psychological well-being. Feasibility was evaluated using dropout rates and behavioral observation data. Acceptability was evaluated from behavioral engagement data, the Friendship Questionnaire (adapted), self-report items, and qualitative questions. Psychological measures were administered to evaluate the feasibility of the trial methods and included the UCLA Loneliness Scale, the 4-item Perceived Stress Scale, a 1-item COVID-19 distress measure, the Flourishing Scale, and the Scale of Positive and Negative Experiences.
RESULTS


The study recruited 30 participants (15 per group). Participants were 22 older adults and 8 younger adults with a health condition. Six participants dropped out of the study. Thus, the data of 24 participants were analyzed (intervention group, 12; waitlist group, 12). The digital human intervention and trial methods were generally found to be feasible and acceptable in younger and older adults living independently, based on intervention completion, and behavioral, qualitative, and some self-report data. The intervention and trial methods were less feasible to nursing home residents who required caregiver assistance. Acceptability could be improved with additional content, tailoring to the population, and changes to the digital human's design.
CONCLUSIONS


Digital humans are a promising and novel technological solution for providing at-risk adults with access to remote psychological support during the COVID-19 pandemic. Research should further examine design techniques to improve their acceptability in this application and investigate intervention effectiveness in a randomized controlled trial.
TRIAL REGISTRATION


Australia New Zealand Clinical Trials Registry ACTRN12620000786998; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380113.",2021,"The digital human intervention and trial methods were generally found to be feasible and acceptable in younger and older adults living independently, based on intervention completion, behavioural, qualitative, and some self-report data.","[""24 participants' data were analysed (12=intervention group; 12=waitlist group"", 'Risk Younger and Older Adults', '30 participants (15 per group) were recruited', 'Participants were 22 older adults, and 8 younger adults with a health condition', 'Participants were adults aged 18-69 years with an underlying medical condition, or aged 70 years or older with a >24 MMSE score (i.e., at greater risk of developing severe COVID-19', 'Participants took part from their place of residence (20= independent living retirement village, 7= community dwelling, 3= nursing home']","['ANZCTR', 'cognitive behavioural and positive psychology exercises with a digital human facilitator', 'remote loneliness and stress intervention with digital human delivery to at-risk adults']","['Friendship Questionnaire (adapted), self-report items and qualitative questions', 'Acceptability', 'UCLA Loneliness Scale, the 4-item Perceived Stress Scale, a 1-item COVID-19 distress measure, the Flourishing Scale, and the Scale of Positive and Negative Experiences']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",22.0,0.245627,"The digital human intervention and trial methods were generally found to be feasible and acceptable in younger and older adults living independently, based on intervention completion, behavioural, qualitative, and some self-report data.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Loveys', 'Affiliation': 'Department of Psychological Medicine, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sagar', 'Affiliation': 'Auckland Bioengineering Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Pickering', 'Affiliation': 'Department of Psychological Medicine, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Broadbent', 'Affiliation': 'Department of Psychological Medicine, The University of Auckland, Auckland, New Zealand.'}]",JMIR mental health,['10.2196/31586']
1740,34566256,Facemasks during aerobic exercise: Implications for cardiac rehabilitation programs during the Covid-19 pandemic.,"INTRODUCTION AND OBJECTIVES


During the COVID-19 pandemic, among the safety measures adopted, use of facemasks during exercise training sessions in cardiac rehabilitation programs raised concerns regarding possible detrimental effects on exercise capacity. Our study examined the cardiorespiratory impact of wearing two types of the most common facemasks during treadmill aerobic training.
METHODS


Twelve healthy health professionals completed three trials of a symptom-limited Bruce treadmill protocol: Without a mask, with a surgical mask and with a respirator. Perceived exertion and dyspnea were evaluated with the Borg Scale of Perceived Exertion and the Borg Dyspnea Scale, respectively. Blood pressure, heart rate and arterial oxygen saturation (SpO2) were measured at each 3-minute stage.
RESULTS


Using a surgical mask or a respirator resulted in a shorter duration of exercise testing. At peak capacity, using a respirator resulted in higher levels of dyspnea and perceived exertion compared to not wearing a facemask. A significant drop in SpO2 was present at the end of exercise testing only when using a respirator. There were no differences in either chronotropic or blood pressure responses between testing conditions.
CONCLUSIONS


Professionals involved in cardiac rehabilitation should be aware of the cardiorespiratory impact of facemasks. Future studies should assess whether exposure to these conditions may impact on the overall results of contemporary cardiac rehabilitation programs.",2021,"At peak capacity, using a respirator resulted in higher levels of dyspnea and perceived exertion compared to not wearing a facemask.",['Twelve healthy health professionals completed three trials of a'],"['symptom-limited Bruce treadmill protocol: Without a mask, with a surgical mask and with a respirator', 'treadmill aerobic training', 'aerobic exercise']","['chronotropic or blood pressure responses', 'Blood pressure, heart rate and arterial oxygen saturation (SpO2', 'SpO2', 'Perceived exertion and dyspnea', 'dyspnea and perceived exertion']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0006309', 'cui_str': 'Brucellosis'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",12.0,0.0408187,"At peak capacity, using a respirator resulted in higher levels of dyspnea and perceived exertion compared to not wearing a facemask.","[{'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Pimenta', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Centro Hospitalar e Universitário de São João, Porto, Portugal.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Tavares', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Centro Hospitalar e Universitário de São João, Porto, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Ramos', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Centro Hospitalar e Universitário de São João, Porto, Portugal.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Centro Hospitalar e Universitário de São João, Porto, Portugal.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reis', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Centro Hospitalar e Universitário de São João, Porto, Portugal.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Amorim', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Centro Hospitalar e Universitário de São João, Porto, Portugal.'}, {'ForeName': 'Afonso', 'Initials': 'A', 'LastName': 'Rocha', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Centro Hospitalar e Universitário de São João, Porto, Portugal.'}]",Revista portuguesa de cardiologia,['10.1016/j.repc.2021.01.017']
1741,34565673,Comments on: Smartphone-based lifestyle coaching modifies behaviours in women with subfertility or recurrent miscarriage: a randomized controlled trial.,,2021,,['women with subfertility or recurrent miscarriage'],['Smartphone-based lifestyle coaching modifies behaviours'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341869', 'cui_str': 'Sub-Fertility, Female'}, {'cui': 'C0000809', 'cui_str': 'Recurrent miscarriage'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],,0.251231,,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.. Electronic address: drlilang@126.com.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2021.08.028']
1742,34571487,Rates of neuromuscular excitation during cycling in Parkinson's disease compared to healthy young and older adults.,"BACKGROUND


Bradykinesia affects mobility in some people with Parkinson's. Fall risk makes the neural control of maximal speed ambulatory movements difficult to study in Parkinson's. Stationary recumbent bicycling favors the use of electromyography at high movement speeds, and may better reveal neuromuscular rate limiters.
METHODS


Subjects were 18 adults with Parkinson's, 14 older adults and 14 young adults. Electromyograms were recorded from two muscles during stationary recumbent bicycling at 60, 80, 100, 120 RPM and peak voluntary cadence. Rate of electromyogram rise was calculated. Subjects performed the timed up and go and four square step test. Parkinson's sub-groups were formed based on whether they could pedal ≥120 RPM. Mixed models were used to compare groups and spearman's correlations quantified relationships.
FINDINGS


Eight people with Parkinson's and four older adults could not complete the 120 RPM condition. Faster people with Parkinson's (n = 10) had greater maximum cadence (F = 42.85, P < 0.05), higher rates of electromyogram rise in both muscles (F > 16.9, P < 0.05), and faster mobility test times (F > 6.5, P < 0.05) than slower people with Parkinson's (n = 8). In Parkinson's, correlations between vastus lateralis rate of electromyogram rise and four square step test (ρ = -0.62), timed up and go (ρ = -0.53), and peak cadence (ρ = 0.76) were significant (all P < 0.05).
INTERPRETATION


People with Parkinson's with slower peak pedaling cadence had slower mobility performance and lower vastus lateralis excitation rates at higher cadences. Vastus lateralis excitation rates had moderate to strong relationships with peak cadence and mobility. Exercise interventions may seek to improve peak cadence or excitation rates in people with Parkinson's.",2021,"INTERPRETATION


People with Parkinson's with slower peak pedaling cadence had slower mobility performance and lower vastus lateralis excitation rates at higher cadences.","['healthy young and older adults', ""Subjects were 18 adults with Parkinson's, 14 older adults and 14 young adults"", ""people with Parkinson's"", ""Eight people with Parkinson's and four older adults""]",['Exercise interventions'],"['Rate of electromyogram rise', 'maximum cadence', 'peak cadence or excitation rates', 'peak cadence', 'faster mobility test times', 'mobility performance and lower vastus lateralis excitation rates', 'vastus lateralis rate of electromyogram rise and four square step test', 'higher rates of electromyogram rise']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0205250', 'cui_str': 'High'}]",18.0,0.0516364,"INTERPRETATION


People with Parkinson's with slower peak pedaling cadence had slower mobility performance and lower vastus lateralis excitation rates at higher cadences.","[{'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Daniels', 'Affiliation': 'University of Delaware, 547 College Ave, Newark, DE, USA. Electronic address: rdaniels@udel.edu.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Knight', 'Affiliation': 'University of Delaware, 547 College Ave, Newark, DE, USA. Electronic address: caknight@udel.edu.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2021.105488']
1743,34571463,Weight loss and its impact on outcome in head and cancer patients during chemo-radiation.,"BACKGROUND


Weight loss during chemotherapy and its impact on the cancer outcomes have been invariably reported in the literature. We also did a post-hoc analysis of a randomized phase III trial to see the same.
MATERIALS AND METHODS


The database of a recently published randomized study comparing cisplatin-radiation with nimotuzumab cisplatin-radiation was used for this analysis. Week-wise weight loss during the course of treatment was noted. The impact of severe weight loss (grade 2-3) on progression-free survival (PFS), locoregional control (LRC) and overall survival (OS) was studied using the Kaplan Meier method. Binary logistic regression analysis was used to see the effect of various factors.
RESULTS


Out of a total of 536 patients, weight loss was captured in 524. Out of these 524 patients, any degree of weight loss was seen in 293 (55.91%) patients. Grade 1 weight loss was noted in 192 (36.6%) patients, grade 2 in 96 (18.3%) and grade 3 in 5 (1%) patients. The 2-year PFS was 53% and 57.1% in severe and non-severe weight loss groups respectively (p-value = 0.36). The 2-year LRC was 60% in patients with severe weight loss, while it was 63.5% in those with non-severe weight loss (p-value = 0.47). The 2-year OS was 59.3% versus 62.2% in severe and non-severe weight loss cohorts respectively (p-value = 0.21). None of the factors was found to be associated with severe weight loss.
CONCLUSION


Severe weight loss was uncommon in our patients. Weight loss during treatment was not associated with poor survival outcomes.",2021,The 2-year OS was 59.3% versus 62.2% in severe and non-severe weight loss cohorts respectively (p-value = 0.21).,['head and cancer patients during chemo-radiation'],['cisplatin-radiation with nimotuzumab cisplatin-radiation'],"['progression-free survival (PFS), locoregional control (LRC) and overall survival (OS', 'severe weight loss', 'Weight loss', 'weight loss', '2-year OS', 'Severe weight loss', '2-year PFS', '2-year LRC', 'Grade 1 weight loss']","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1570308', 'cui_str': 'Nimotuzumab'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]",536.0,0.0481193,The 2-year OS was 59.3% versus 62.2% in severe and non-severe weight loss cohorts respectively (p-value = 0.21).,"[{'ForeName': 'Gunjesh Kumar', 'Initials': 'GK', 'LastName': 'Singh', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre and HBNI, Mumbai 400012, India.'}, {'ForeName': 'Vijay M', 'Initials': 'VM', 'LastName': 'Patil', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre and HBNI, Mumbai 400012, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre and HBNI, Mumbai 400012, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre and HBNI, Mumbai 400012, India.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Menon', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre and HBNI, Mumbai 400012, India.'}, {'ForeName': 'Sarbani Ghosh', 'Initials': 'SG', 'LastName': 'Lashkar', 'Affiliation': 'Department of Radiotherapy, Tata Memorial Hospital, Tata Memorial Centre and HBNI, Mumbai 400012, India.'}, {'ForeName': 'Vijayalakshmi', 'Initials': 'V', 'LastName': 'Mathrudev', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre and HBNI, Mumbai 400012, India.'}, {'ForeName': 'Kavita Nawale', 'Initials': 'KN', 'LastName': 'Satam', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre and HBNI, Mumbai 400012, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre and HBNI, Mumbai 400012, India. Electronic address: kumarprabhashtmh@gmail.com.'}]",Oral oncology,['10.1016/j.oraloncology.2021.105522']
1744,34581678,Intervening on Trust in Science to Reduce Belief in COVID-19 Misinformation and Increase COVID-19 Preventive Behavioral Intentions: Randomized Controlled Trial.,"BACKGROUND


Trust in science meaningfully contributes to our understanding of people's belief in misinformation and their intentions to take actions to prevent COVID-19. However, no experimental research has sought to intervene on this variable to develop a scalable response to the COVID-19 infodemic.
OBJECTIVE


Our study examined whether brief exposure to an infographic about the scientific process might increase trust in science and thereby affect belief in misinformation and intention to take preventive actions for COVID-19.
METHODS


This two-arm, parallel-group, randomized controlled trial aimed to recruit a US representative sample of 1000 adults by age, race/ethnicity, and gender using the Prolific platform. Participants were randomly assigned to view either an intervention infographic about the scientific process or a control infographic. The intervention infographic was designed through a separate pilot study. Primary outcomes were trust in science, COVID-19 narrative belief profile, and COVID-19 preventive behavioral intentions. We also collected 12 covariates and incorporated them into all analyses. All outcomes were collected using web-based assessment.
RESULTS


From January 22, 2021 to January 24, 2021, 1017 participants completed the study. The intervention slightly improved trust in science (difference-in-difference 0.03, SE 0.01, t 1000 =2.16, P=.031). No direct intervention effect was observed on belief profile membership, but there was some evidence of an indirect intervention effect mediated by trust in science (adjusted odds ratio 1.06, SE 0.03, 95% CI 1.00-1.12, z=2.01, P=.045) on membership in the ""scientific"" profile compared with the others. No direct nor indirect effects on preventive behaviors were observed.
CONCLUSIONS


Briefly viewing an infographic about science appeared to cause a small aggregate increase in trust in science, which may have, in turn, reduced the believability of COVID-19 misinformation. The effect sizes were small but commensurate with our 60-second, highly scalable intervention approach. Researchers should study the potential for truthful messaging about how science works to serve as misinformation inoculation and test how best to do so.
TRIAL REGISTRATION


NCT04557241; https://clinicaltrials.gov/ct2/show/NCT04557241.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/24383.",2021,"The intervention slightly improved trust in science (difference-in-difference 0.03, SE=0.01, t=2.16, p=.031).","['From January 22 to 24, 2021, 1017 participants completed the study', '1000 adults by age, race/ethnicity, and gender using the Prolific platform']",['intervention infographic about the scientific process or a control infographic'],"['preventive behaviors', 'trust in science, COVID-19 narrative belief profile, and COVID-19 preventive behavioral intentions']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",12.0,0.192151,"The intervention slightly improved trust in science (difference-in-difference 0.03, SE=0.01, t=2.16, p=.031).","[{'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Agley', 'Affiliation': 'Prevention Insights, Department of Applied Health Science, School of Public Health Bloomington, Indiana University Bloomington, Bloomington, IN, United States.'}, {'ForeName': 'Yunyu', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, United States.'}, {'ForeName': 'Esi E', 'Initials': 'EE', 'LastName': 'Thompson', 'Affiliation': 'Indiana University Media School, Indiana University Bloomington, Bloomington, IN, United States.'}, {'ForeName': 'Xiwei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Biostatistics Consulting Center, School of Public Health Bloomington, Indiana University Bloomington, Bloomington, IN, United States.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Golzarri-Arroyo', 'Affiliation': 'Biostatistics Consulting Center, School of Public Health Bloomington, Indiana University Bloomington, Bloomington, IN, United States.'}]",Journal of medical Internet research,['10.2196/32425']
1745,34580114,Randomized Phase II Study of PARP Inhibitor ABT-888 (Veliparib) with Modified FOLFIRI versus FOLFIRI as Second-line Treatment of Metastatic Pancreatic Cancer: SWOG S1513.,"PURPOSE


PARP inhibitors synergize with topoisomerase inhibitors, and veliparib plus modified (m) FOLFIRI (no 5-FU bolus) had preliminary activity in metastatic pancreatic cancers. This study evaluated the safety and efficacy of second-line treatment with veliparib and mFOLFIRI versus FOLFIRI (control) for metastatic pancreatic cancer.
PATIENTS AND METHODS


This randomized phase II clinical trial led by the SWOG Cancer Research Network enrolled patients between September 1, 2016 and December 13, 2017. The median follow-up was 9 months (IQR 1-27).  BRCA1/2  and homologous recombination DNA damage repair (HR-DDR) genetic defects were tested in blood and tumor biopsies. Patients received veliparib 200 mg twice daily, days 1-7 with mFOLFIRI days 3-5, or FOLFIRI in 14-day cycles.
RESULTS


After 123 of planned 143 patients were accrued, an interim futility analysis indicated that the veliparib arm was unlikely to be superior to control, and the study was halted. Median overall survival (OS) was 5.4 versus 6.5 months (HR, 1.23;  P  = 0.28), and median progression-free survival (PFS) was 2.1 versus 2.9 months (HR, 1.39;  P  = 0.09) with veliparib versus control. Grade 3/4 toxicities were more common with veliparib (69% vs. 58%,  P  = 0.23). For cancers with HR-DDR defects versus wild-type, median PFS and OS were 7.3 versus 2.5 months ( P  = 0.05) and 10.1 versus 5.9 months ( P  = 0.17), respectively, with FOLFIRI, and 2.0 versus 2.1 months ( P  = 0.62) and 7.4 versus 5.1 months ( P  = 0.10), respectively, with veliparib plus mFOLFIRI.
CONCLUSIONS


Veliparib plus mFOLFIRI did not improve survival for metastatic pancreatic cancer. FOLFIRI should be further studied in pancreatic cancers with HR-DDR defects.",2021,"Median survival (OS) was 5.4 vs 6.5 months (HR 1.23, p=0.28), and median progression free survival (PFS) was 2.1 vs 2.9 months (HR 1.39, p=0.09) with veliparib vs control.","['metastatic pancreatic cancers (mPC', 'SWOG Cancer Research Network enrolled patients between September 1, 2016 and December 13, 2017', 'Metastatic Pancreatic Cancer', 'After 123 of planned 143 patients']","['PARP Inhibitor Veliparib with Modified FOLFIRI versus FOLFIRI', 'Poly (ADP-ribose) polymerase (PARP) inhibitors synergize with topoisomerase inhibitors, and veliparib plus modified (m) FOLFIRI (no 5-FU bolus', 'veliparib and mFOLFIRI vs FOLFIRI (control', 'veliparib 200 mg twice daily, days 1-7 with mFOLFIRI days 3-5, or FOLFIRI']","['safety and efficacy', 'survival for mPC', 'median progression free survival (PFS', 'Median survival (OS', 'median PFS and OS', 'Grade 3/4 toxicities', 'BRCA1/2  and homologous recombination DNA damage repair (HR-DDR) genetic defects']","[{'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1567710', 'cui_str': 'PARP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0598317', 'cui_str': 'Topoisomerase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442758', 'cui_str': '3/5'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0012899', 'cui_str': 'DNA repair'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",143.0,0.0573221,"Median survival (OS) was 5.4 vs 6.5 months (HR 1.23, p=0.28), and median progression free survival (PFS) was 2.1 vs 2.9 months (HR 1.39, p=0.09) with veliparib vs control.","[{'ForeName': 'E Gabriela', 'Initials': 'EG', 'LastName': 'Chiorean', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington. gchiorea@uw.edu.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Philip', 'Affiliation': 'Karmanos Cancer Institute, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Jalikis', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Pishvaian', 'Affiliation': 'Georgetown University, Lombardi Cancer Center, Washington, DC.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Berlin', 'Affiliation': 'Vanderbilt University, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.'}, {'ForeName': 'Marcus S', 'Initials': 'MS', 'LastName': 'Noel', 'Affiliation': 'Georgetown University, Lombardi Cancer Center, Washington, DC.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Suga', 'Affiliation': 'Kaiser Permanente, Vallejo, California.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Garrido-Laguna', 'Affiliation': 'University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah.'}, {'ForeName': 'Dana Backlund', 'Initials': 'DB', 'LastName': 'Cardin', 'Affiliation': 'Vanderbilt University, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Radke', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Duong', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Bellasea', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Lowy', 'Affiliation': 'University of California San Diego, Moores Cancer Center, La Jolla, California.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-1789']
1746,34579067,Night Vision and Carotenoids (NVC): A Randomized Placebo Controlled Clinical Trial on Effects of Carotenoid Supplementation on Night Vision in Older Adults.,"Twilight and low luminance levels are visually challenging environments for the elderly, especially when driving at night. Carotenoid rich diets are known to increase macular pigment optical density (MPOD), which in turn leads to an improvement in visual function. It is not known whether augmenting MPOD can lead to a decrease in vision related night driving difficulties. Additionally, it is unknown if carotenoid supplementation provides additional measurable benefits to one's useful field of view (UFOV) along with a decreased composite crash risk score. The aim of the study was to evaluate changes in night vision function and UFOV in individuals that took carotenoid vitamin supplements for a six-month period compared to a placebo group.
METHODS


A prospective, randomized, double-blind, six-month trial of a 14 mg zeaxanthin/7 mg lutein-based supplement was carried out. Participants were randomized into active or placebo group (approx 2:1).
RESULTS


n  = 33 participants (26 males/7 females) participated with 93% capsule intake compliance in the supplemented group ( n  = 24) and placebo group ( n  = 9). MPOD (mean/standard error SE) in the active group increased in the Right eye from 0.35 density units (du)/0.04 SE to 0.41 du/0.05 SE;  p  < 0.001 and in the Left eye from 0.35 du/0.05 SE to 0.37 du,  p  > 0.05). The supplemented group showed significant improvements in contrast sensitivity with glare in both eyes with improvements in LogMAR scores of 0.147 and 0.149, respectively ( p  = 0.02 and 0.01, respectively), monocularly tested glare recovery time improved 2.76 and 2.54 s, respectively, ( p  = 0.008 and  p  = 0.02), and we also noted a decreased preferred luminance required to complete visual tasks ( p  = 0.02 and 0.03). Improvements in UFOV scores of divided attention ( p  < 0.001) and improved composite crash risk score ( p  = 0.004) were seen in the supplemented group. The placebo group remained unchanged.
CONCLUSIONS


The NVC demonstrates that augmenting MPOD in individuals with difficulty in night vision showed measurable benefits in numerous visual functions that are important for night vision driving in this small sample RCT. Additionally, we observed an improvement in UFOV divided attention test scores and decreased composite risk scores.",2021,Improvements in UFOV scores of divided attention ( p  < 0.001) and improved composite crash risk score ( p  = 0.004) were seen in the supplemented group.,"['n  = 33 participants (26 males/7 females) participated with 93', 'group', 'individuals that took', 'Older Adults']","['carotenoid vitamin supplements', 'Placebo', 'Carotenoid rich diets', 'Night Vision and Carotenoids (NVC', 'zeaxanthin/7 mg lutein-based supplement', 'placebo', 'Carotenoid Supplementation']","['macular pigment optical density (MPOD', 'UFOV divided attention test scores and decreased composite risk scores', 'contrast sensitivity with glare', 'composite crash risk score', 'UFOV scores of divided attention', 'monocularly tested glare recovery time', 'MPOD', 'Twilight and low luminance levels', 'capsule intake compliance', 'night vision function and UFOV', 'preferred luminance required to complete visual tasks', 'Night Vision', 'LogMAR scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010985', 'cui_str': 'Dark adaptation'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0589101', 'cui_str': 'Divided attention'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0278215', 'cui_str': 'Glare'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0234684', 'cui_str': 'Luminance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0010985', 'cui_str': 'Dark adaptation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",,0.162449,Improvements in UFOV scores of divided attention ( p  < 0.001) and improved composite crash risk score ( p  = 0.004) were seen in the supplemented group.,"[{'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Richer', 'Affiliation': 'Captain James A Lovell Fed Health Care Facility, North Chicago, IL 60064, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Novil', 'Affiliation': 'Captain James A Lovell Fed Health Care Facility, North Chicago, IL 60064, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Gullett', 'Affiliation': 'Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, IL 60064, USA.'}, {'ForeName': 'Avni', 'Initials': 'A', 'LastName': 'Dervishi', 'Affiliation': 'Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, IL 60064, USA.'}, {'ForeName': 'Sherwin', 'Initials': 'S', 'LastName': 'Nassiri', 'Affiliation': 'Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, IL 60064, USA.'}, {'ForeName': 'Co', 'Initials': 'C', 'LastName': 'Duong', 'Affiliation': 'Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, IL 60064, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Davis', 'Affiliation': 'Davis Eye Care Associates, Oak Lawn, IL 60453, USA.'}, {'ForeName': 'Pinakin Gunvant', 'Initials': 'PG', 'LastName': 'Davey', 'Affiliation': 'College of Optometry, Western University of Health Sciences, Pomona, CA 91766, USA.'}]",Nutrients,['10.3390/nu13093191']
1747,34579066,Nitrogen Balance after the Administration of a Prolonged-Release Protein Substitute for Phenylketonuria as a Single Dose in Healthy Volunteers.,"Nitrogen balance is the difference between nitrogen excreted as urea and nitrogen ingested, mainly in proteins. Increased circulating concentrations of amino acids (AA) in the bloodstream are usually associated with proportional increases in the production and excretion of urea. Previously, we reported results from a randomized, controlled, single-dose, crossover trial in healthy adult volunteers (n = 30) (Trial Registration: ISRCTN11016729), in which a Test product (prolonged-release AA mixture formulated with Physiomimic Technology™ (PT™)) significantly slowed down the release and reduced the peak plasma concentrations of essential AAs compared with a free AA mixture (Reference product) while maintaining essential AA bioavailability. Here, we report an assessment of the nitrogen balance from the same study. The amount of nitrogen contained in plasma AAs, levels of blood urea nitrogen (BUN) ( p  < 0.0001) and changes in BUN ( p  < 0.0001) were smaller after the Test product compared with the Reference product. These findings suggest that the production of urea in proportion to systemic AA availability was significantly smaller after the administration of the Test product compared with the Reference product and that the test product conferred the increased utilization of AAs for protein synthesis and reduced their oxidation and conversion to urea. In the clinical setting, it is possible that the effects of PT™ observed on the disposition of free AAs in this study may translate to health benefits in terms of physiological body composition and growth if used for the treatment of subjects with phenylketonuria (PKU). Further investigation in patients with PKU is warranted.",2021,"The amount of nitrogen contained in plasma AAs, levels of blood urea nitrogen (BUN) ( p  < 0.0001) and changes in BUN ( p  < 0.0001) were smaller after the Test product compared with the Reference product.","['Healthy Volunteers', 'patients with PKU', 'healthy adult volunteers (n = 30', 'subjects with phenylketonuria (PKU']",[],"['changes in BUN', 'Nitrogen balance', 'systemic AA availability', 'peak plasma concentrations of essential AAs', 'circulating concentrations of amino acids (AA', 'production and excretion of urea', 'Nitrogen Balance', 'amount of nitrogen contained in plasma AAs, levels of blood urea nitrogen (BUN']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0429631', 'cui_str': 'Nitrogen balance'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0175701', 'cui_str': 'Aarskog syndrome'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C4518417', 'cui_str': 'Contained in'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0684255,"The amount of nitrogen contained in plasma AAs, levels of blood urea nitrogen (BUN) ( p  < 0.0001) and changes in BUN ( p  < 0.0001) were smaller after the Test product compared with the Reference product.","[{'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'CRST Oy, Itäinen Pitkäkatu 4B, FI-20520 Turku, Finland.'}, {'ForeName': 'Jouni', 'Initials': 'J', 'LastName': 'Junnila', 'Affiliation': 'Oy 4Pharma Ltd., Arkadiankatu 7, FI-00100 Helsinki, Finland.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Reiner', 'Affiliation': 'APR Applied Pharma Research SA, Via Corti 5, CH-6828 Balerna, Switzerland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'MacDonald', 'Affiliation': ""Dietetic Department, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham B4 6NH, UK.""}, {'ForeName': 'Ania C', 'Initials': 'AC', 'LastName': 'Muntau', 'Affiliation': ""University Medical Center Hamburg Eppendorf, University Children's Hospital, Martinistrasse 52, D-20246 Hamburg, Germany.""}]",Nutrients,['10.3390/nu13093189']
1748,34579064,Krill Protein Hydrolysate Provides High Absorption Rate for All Essential Amino Acids-A Randomized Control Cross-Over Trial.,"BACKGROUND


adequate protein intake is essential to humans and, since the global demand for protein-containing foods is increasing, identifying new high-quality protein sources is needed. In this study, we investigated the acute postprandial bioavailability of amino acids (AAs) from a krill protein hydrolysate compared to a soy and a whey protein isolate.
METHODS


the study was a randomized, placebo-controlled crossover trial including ten healthy young males. On four non-consecutive days, volunteers consumed water or one of three protein-matched supplements: whey protein isolate, soy protein isolate or krill protein hydrolysate. Blood samples were collected prior to and until 180 min after consumption. Serum postprandial AA concentrations were determined using  1 H NMR spectroscopy. Hunger and satiety were assessed using visual analogue scales (VAS).
RESULTS


whey and krill resulted in significantly higher AA concentrations compared to soy between 20-60 min and 20-40 min after consumption, respectively. Area under the curve (AUC) analyses revealed that whey resulted in the highest postprandial serum concentrations of essential AAs (EAAs) and branched chain AAs (BCAAs), followed by krill and soy, respectively.
CONCLUSIONS


krill protein hydrolysate increases postprandial serum EAA and BCAA concentrations in a superior manner to soy protein isolate and thus might represent a promising future protein source in human nutrition.",2021,"Area under the curve (AUC) analyses revealed that whey resulted in the highest postprandial serum concentrations of essential AAs (EAAs) and branched chain AAs (BCAAs), followed by krill and soy, respectively.
",['ten healthy young males'],"['Krill Protein Hydrolysate', 'amino acids (AAs', 'placebo', 'krill protein hydrolysate', 'protein-matched supplements: whey protein isolate, soy protein isolate or krill protein hydrolysate']","['postprandial serum EAA and BCAA concentrations', 'highest postprandial serum concentrations of essential AAs (EAAs) and branched chain AAs (BCAAs', 'AA concentrations', 'Serum postprandial AA concentrations', 'Hunger and satiety', 'visual analogue scales (VAS']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0022787', 'cui_str': 'Krill'}, {'cui': 'C0033631', 'cui_str': 'protein hydrolysates'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0677666', 'cui_str': 'soy protein isolate'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0243046', 'cui_str': 'Excitatory Amino Acid'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0175701', 'cui_str': 'Aarskog syndrome'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",10.0,0.074323,"Area under the curve (AUC) analyses revealed that whey resulted in the highest postprandial serum concentrations of essential AAs (EAAs) and branched chain AAs (BCAAs), followed by krill and soy, respectively.
","[{'ForeName': 'Rebekka', 'Initials': 'R', 'LastName': 'Thøgersen', 'Affiliation': 'Department of Food Science, Aarhus University, Agro Food Park 48, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Hanne Christine', 'Initials': 'HC', 'LastName': 'Bertram', 'Affiliation': 'Department of Food Science, Aarhus University, Agro Food Park 48, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Mathias T', 'Initials': 'MT', 'LastName': 'Vangsoe', 'Affiliation': 'Aker Biomarine Antarctic AS, Oksenøyveien 10, NO-1327 Lysaker, Norway.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Department for Public Health, Aarhus University, Dalgas Av. 4, 8000 Aarhus C, Denmark.'}]",Nutrients,['10.3390/nu13093187']
1749,34586459,The efficacy and safety of levilimab in severely ill COVID-19 patients not requiring mechanical ventilation: results of a multicenter randomized double-blind placebo-controlled phase III CORONA clinical study.,"OBJECTIVE AND DESIGN


The aim of this double-blind, placebo-controlled, phase III CORONA clinical trial was to evaluate the efficacy and safety of IL-6 receptor inhibitor levilimab (LVL) in subjects with severe COVID-19.
SUBJECTS


The study included 217 patients. The eligible were men and non-pregnant women aged 18 years or older, hospitalized for severe COVID-19 pneumonia.
TREATMENT


206 subjects were randomized (1:1) to receive single subcutaneous administration of LVL 324 mg or placebo, both in combination with standard of care (SOC). 204 patients received allocated therapy. After the LVL/placebo administration in case of deterioration of symptoms, the investigator could perform a single open-label LVL 324 mg administration as the rescue therapy.
METHODS


The primary efficacy endpoint was the proportion of patients with sustained clinical improvement on the 7-category ordinal scale on Day 14. All efficacy data obtained after rescue therapy administration were considered missing. For primary efficacy analysis, all subjects with missing data were considered non-responders.
RESULTS


63.1% and 42.7% of patients in the LVL and in the placebo groups, respectively, achieved sustained clinical improvement on Day 14 (P = .0017). The frequency of adverse drug reactions was comparable between the groups.
CONCLUSION


In patients with radiologically confirmed SARS-CoV-2 pneumonia, requiring or not oxygen therapy (but not ventilation) with no signs of other active infection administration of LVL + SOC results in an increase of sustained clinical improvement rate.
TRAIL REGISTRATION


The trial is registered at the US National Institutes of Health (ClinicalTrials.gov; NCT04397562).",2021,"The frequency of adverse drug reactions was comparable between the groups.
","['204 patients received allocated therapy', '206 subjects', 'eligible were men and non-pregnant women aged 18\xa0years or older, hospitalized for severe COVID-19 pneumonia', 'subjects with severe COVID-19', 'severely ill COVID-19 patients not requiring mechanical ventilation', '217 patients']","['LVL 324\xa0mg or placebo, both in combination with standard of care (SOC', 'IL-6 receptor inhibitor levilimab (LVL', 'LVL/placebo', 'levilimab', 'placebo']","['frequency of adverse drug reactions', 'efficacy and safety', 'proportion of patients with sustained clinical improvement on the 7-category ordinal scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C4517646', 'cui_str': '217'}]","[{'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",217.0,0.631975,"The frequency of adverse drug reactions was comparable between the groups.
","[{'ForeName': 'Nikita V', 'Initials': 'NV', 'LastName': 'Lomakin', 'Affiliation': 'Federal State Budgetary Institution Central Clinical Hospital of the Management Affair of President Russian Federation (FSBI CCH), Moscow, Russian Federation.'}, {'ForeName': 'Bulat A', 'Initials': 'BA', 'LastName': 'Bakirov', 'Affiliation': 'Federal State Budgetary Educational Institution of Higher Education ""Bashkir State Medical University of the Ministry of Healthcare of the Russian Federation"" (FSBEI HE BSMU of the Ministry of Health of Russia), Ufa, Russian Federation.'}, {'ForeName': 'Denis N', 'Initials': 'DN', 'LastName': 'Protsenko', 'Affiliation': 'State Budgetary Healthcare Institution of the City of Moscow Municipal Clinical Hospital No. 40 of the Moscow Healthcare Department (SBHI MCH No. 40 MHD), Moscow, Russian Federation.'}, {'ForeName': 'Vadim I', 'Initials': 'VI', 'LastName': 'Mazurov', 'Affiliation': 'Federal State Budgetary Educational Institution of Higher Education ""I.I. Mechnikov North-Western State Medical University"", Ministry of Healthcare of the Russian Federation (FSBEI HE I.I. Mechnikov NWSMU, Ministry of Health of Russia), St. Petersburg, Russian Federation.'}, {'ForeName': 'Gaziyavdibir H', 'Initials': 'GH', 'LastName': 'Musaev', 'Affiliation': 'State Budgetary Institution of the Republic of Dagestan ""Republican Clinical Hospital"" (SBU RD RCH), Makhachkala, Russian Federation.'}, {'ForeName': 'Olga M', 'Initials': 'OM', 'LastName': 'Moiseeva', 'Affiliation': 'Federal State Budgetary Institution ""Almazov National Medical Research Center"", Ministry of Health of the Russian Federation (Almazov National Medical Research Center), St. Petersburg, Russian Federation.'}, {'ForeName': 'Elena S', 'Initials': 'ES', 'LastName': 'Pasechnik', 'Affiliation': 'State Budgetary Healthcare Institution «Kaluga Regional Clinical Hospital» (SBHI KR KRCH), Kaluga, Russian Federation.'}, {'ForeName': 'Vladimir V', 'Initials': 'VV', 'LastName': 'Popov', 'Affiliation': 'Private Healthcare Institution N.A. Semashko Clinical Hospital «RZD-Medicine» (PHI N.A. Semashko Railroad Clinical Hospital), (Formerly Known As Non-State Healthcare Institution N.A. Semashko Railroad Clinical Hospital at the Lyublino Station of the JSC Russian Railways), Institute of Continues Medical Education Moscow State University of Food Production, Moscow, Russian Federation.'}, {'ForeName': 'Elena A', 'Initials': 'EA', 'LastName': 'Smolyarchuk', 'Affiliation': 'Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation (Sechenov University), [FSAEI HE I.M. Sechenov First MSMU, Ministry of Health of Russia (Sechenov University)], Moscow, Russian Federation.'}, {'ForeName': 'Ivan G', 'Initials': 'IG', 'LastName': 'Gordeev', 'Affiliation': 'Moscow State Budgetary Healthcare Institution O.M. Filatov Municipal Clinical Hospital No. 15 of the Moscow Healthcare Department) (SBHI MCH No. 15 MHD) (formerly known as the State Healthcare Institution of Moscow O.M. Filatov Municipal Clinical Hospital No. 15 of the Moscow Healthcare Department), Moscow, Russian Federation.'}, {'ForeName': 'Mikhail Yu', 'Initials': 'MY', 'LastName': 'Gilyarov', 'Affiliation': 'State Budgetary Healthcare Institution of the City of Moscow N.I. Pirogov Municipal Clinical Hospital No. 1 of the Moscow Healthcare Department (N.I. Pirogov MCH No. 1), Moscow, Russian Federation.'}, {'ForeName': 'Darya S', 'Initials': 'DS', 'LastName': 'Fomina', 'Affiliation': 'State Budgetary Healthcare Institution of the City of Moscow Municipal Clinical Hospital No. 52 of the Moscow Healthcare Department (SBHI MCH No. 52 MHD), Moscow, Russian Federation.'}, {'ForeName': 'Anton I', 'Initials': 'AI', 'LastName': 'Seleznev', 'Affiliation': 'JSC BIOCAD, Ul. Italianskaya 17, St-Petersburg, Russia, 191186.'}, {'ForeName': 'Yulia N', 'Initials': 'YN', 'LastName': 'Linkova', 'Affiliation': 'JSC BIOCAD, Ul. Italianskaya 17, St-Petersburg, Russia, 191186.'}, {'ForeName': 'Ekaterina A', 'Initials': 'EA', 'LastName': 'Dokukina', 'Affiliation': 'JSC BIOCAD, Ul. Italianskaya 17, St-Petersburg, Russia, 191186.'}, {'ForeName': 'Anna V', 'Initials': 'AV', 'LastName': 'Eremeeva', 'Affiliation': 'JSC BIOCAD, Ul. Italianskaya 17, St-Petersburg, Russia, 191186.'}, {'ForeName': 'Polina S', 'Initials': 'PS', 'LastName': 'Pukhtinskaia', 'Affiliation': 'JSC BIOCAD, Ul. Italianskaya 17, St-Petersburg, Russia, 191186. puhtinskaya@biocad.ru.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Morozova', 'Affiliation': 'JSC BIOCAD, Ul. Italianskaya 17, St-Petersburg, Russia, 191186.'}, {'ForeName': 'Arina V', 'Initials': 'AV', 'LastName': 'Zinkina-Orikhan', 'Affiliation': 'JSC BIOCAD, Ul. Italianskaya 17, St-Petersburg, Russia, 191186.'}, {'ForeName': 'Anton A', 'Initials': 'AA', 'LastName': 'Lutckii', 'Affiliation': 'JSC BIOCAD, Ul. Italianskaya 17, St-Petersburg, Russia, 191186.'}]",Inflammation research : official journal of the European Histamine Research Society ... [et al.],['10.1007/s00011-021-01507-5']
1750,34585377,OPTIMISE: a pragmatic stepped wedge cluster randomised trial of an intervention to improve primary care for refugees in Australia.,"OBJECTIVES


To examine whether primary care outreach facilitation improves the quality of care for general practice patients from refugee backgrounds.
DESIGN


Pragmatic, cluster randomised controlled trial, with stepped wedge allocation to early or late intervention groups.
SETTING, PARTICIPANTS


31 general practices in three metropolitan areas of Sydney and Melbourne with high levels of refugee resettlement, November 2017 - August 2019.
INTERVENTION


Trained facilitators made three visits to practices over six months, using structured action plans to help practice teams optimise routines of refugee care.
MAJOR OUTCOME MEASURE


Change in proportion of patients from refugee backgrounds with documented health assessments (Medicare billing). Secondary outcomes were refugee status recording, interpreter use, and clinician-perceived difficulty in referring patients to appropriate dental, social, settlement, and mental health services.
RESULTS


Our sample comprised 14 633 patients. The intervention was associated with an increase in the proportion of patients with Medicare-billed health assessments during the preceding six months, from 19.1% (95% CI, 18.6-19.5%) to 27.3% (95% CI, 26.7-27.9%; odds ratio, 1.88; 95% CI, 1.42-2.50). The impact of the intervention was greater in smaller practices, practices with larger proportions of patients from refugee backgrounds, recent training in refugee health care, or higher baseline provision of health assessments for such patients. There was no impact on refugee status recording, interpreter use increased modestly, and reported difficulties in refugee-specific referrals to social, settlement and dental services were reduced.
CONCLUSIONS


Low intensity practice facilitation may improve some aspects of primary care for people from refugee backgrounds. Facilitators employed by local health services could support integrated approaches to enhancing the quality of primary care for this vulnerable population.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry, ACTRN12618001970235 (retrospective).",2021,"The impact of the intervention was greater in smaller practices, practices with larger proportions of patients from refugee backgrounds, recent training in refugee health care, or higher baseline provision of health assessments for such patients.","['Our sample comprised 14\xa0633 patients', '31 general practices in three metropolitan areas of Sydney and Melbourne with high levels of refugee resettlement, November 2017 - August 2019', 'primary care for refugees in Australia', 'general practice patients from refugee backgrounds']",['primary care outreach facilitation'],"['health assessments (Medicare billing', 'proportion of patients with Medicare-billed health assessments', 'refugee status recording, interpreter use, and clinician-perceived difficulty in referring patients to appropriate dental, social, settlement, and mental health services', 'quality of care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}]","[{'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0150646', 'cui_str': 'Interpreter'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}]",14633.0,0.161612,"The impact of the intervention was greater in smaller practices, practices with larger proportions of patients from refugee backgrounds, recent training in refugee health care, or higher baseline provision of health assessments for such patients.","[{'ForeName': 'Grant M', 'Initials': 'GM', 'LastName': 'Russell', 'Affiliation': 'Monash University, Melbourne, VIC.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Long', 'Affiliation': 'Monash University, Melbourne, VIC.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Lewis', 'Affiliation': 'Australian Institute for Primary Care and Ageing, La Trobe University, Melbourne, VIC.'}, {'ForeName': 'Joanne C', 'Initials': 'JC', 'LastName': 'Enticott', 'Affiliation': 'Monash Centre for Health Research and Implementation, Monash University, Melbourne, VIC.'}, {'ForeName': 'Nilakshi', 'Initials': 'N', 'LastName': 'Gunatillaka', 'Affiliation': 'Australian Institute for Primary Care and Ageing, La Trobe University, Melbourne, VIC.'}, {'ForeName': 'I-Hao', 'Initials': 'IH', 'LastName': 'Cheng', 'Affiliation': 'Monash University, Melbourne, VIC.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Marsh', 'Affiliation': 'Australian Institute for Primary Care and Ageing, La Trobe University, Melbourne, VIC.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Vasi', 'Affiliation': 'Monash University, Melbourne, VIC.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Advocat', 'Affiliation': 'Monash University, Melbourne, VIC.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Centre for Primary Health Care and Equity, UNSW, Sydney, NSW.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Centre for Primary Health Care and Equity, UNSW, Sydney, NSW.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Casey', 'Affiliation': 'Victorian Foundation for Survivors of Torture, Melbourne, VIC.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'NSW Refugee Health Service, South Western Sydney Local Health District, Sydney, NSW.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Harris', 'Affiliation': 'Centre for Primary Health Care and Equity, UNSW, Sydney, NSW.'}]",The Medical journal of Australia,['10.5694/mja2.51278']
1751,34583841,Poor suitability for psychotherapy - a risk factor for treatment non-attendance?,"BACKGROUND


Patient suitability has been suggested to predict treatment non-attendance but information on its effect is limited.
AIM


To study the prediction of the Suitability for Psychotherapy Scale (SPS), on occurrence of treatment non-attendance.
METHODS


Altogether 326 outpatients, with depressive or anxiety disorder, were randomized to short-term psychodynamic psychotherapy (SPP), long-term psychodynamic psychotherapy (LPP), and solution-focused therapy (SFT). SPS was based on seven components from three suitability domains: nature of problems, ego strength, and self-observing capacity. Treatment non-attendance was defined as refusal of engaging therapy and of premature termination. The Cox model and logistic regression were used.
RESULTS


Treatment non-attendance was significantly more common in LPP patients with poor SPS (RR = 2.76, 95% CI = 1.45-5.26). This was mainly due to poor flexibility of interaction, poor self-concept, and poor reflective ability. Premature termination in SFT showed a similar trend but due to other SPS components: absence of a circumscribed problem, poor modulation of affects, and poor response to trial interpretation. On the contrary, individuals with good values of SPS were more prone to premature termination in SPP.
LIMITATIONS


The prediction of suitability on refusal could only be studied in the LPP group due to few refusals in the short-term therapy groups. The sample consisted of patients who participated in a trial. Thus the findings may not be directly generalized to unselected patients in the public mental health setting.
CONCLUSIONS


Poor suitability, apparently, predicts non-attendance in LPP and SFT, but not in SPP. More studies on large cohorts are needed.",2021,"RESULTS


Treatment non-attendance was significantly more common in LPP patients with poor SPS (RR = 2.76, 95% CI = 1.45-5.26).","['Altogether 326 outpatients, with depressive or anxiety disorder', 'unselected patients in the public mental health setting']","['short-term psychodynamic psychotherapy (SPP), long-term psychodynamic psychotherapy (LPP), and solution-focused therapy (SFT', 'Psychotherapy Scale (SPS']",[],"[{'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1261382', 'cui_str': 'Psychodynamic psychotherapy'}, {'cui': 'C0579055', 'cui_str': 'Long-term psychodynamic psychotherapy'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",[],326.0,0.0348663,"RESULTS


Treatment non-attendance was significantly more common in LPP patients with poor SPS (RR = 2.76, 95% CI = 1.45-5.26).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knekt', 'Affiliation': 'Finnish Institute for Health and Welfare, Helsinki, Finland. Electronic address: paul.knekt@thl.fi.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Grandell', 'Affiliation': 'Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sares-Jäske', 'Affiliation': 'Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Olavi', 'Initials': 'O', 'LastName': 'Lindfors', 'Affiliation': 'Finnish Institute for Health and Welfare, Helsinki, Finland; University of Helsinki, Department of Psychology and Logopedics, Helsinki, Finland.'}]",Journal of affective disorders,['10.1016/j.jad.2021.09.020']
1752,34582775,Predictors of outcome in the ISCHEMIA-CKD trial: Anatomy versus ischemia.,"BACKGROUND


The ISCHEMIA-CKD (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches-Chronic Kidney Disease) trial found no advantage to an invasive strategy compared to conservative management in reducing all-cause death or myocardial infarction (D/MI). However, the prognostic influence of angiographic coronary artery disease (CAD) burden and ischemia severity remains unknown in this population. We compared the relative impact of CAD extent and severity of myocardial ischemia on D/MI in patients with advanced chronic kidney disease (CKD).
METHODS


Participants randomized to invasive management with available data on coronary angiography and stress testing were included. Extent of CAD was defined by the number of major epicardial vessels with ≥50% diameter stenosis by quantitative coronary angiography. Ischemia severity was assessed by site investigators as moderate or severe using trial definitions. The primary endpoint was D/MI.
RESULTS


Of the 388 participants, 307 (79.1%) had complete coronary angiography and stress testing data. D/MI occurred in 104/307 participants (33.9%). Extent of CAD was associated with an increased risk of D/MI (P < .001), while ischemia severity was not (P = .249). These relationships persisted following multivariable adjustment. Using 0-vessel disease (VD) as reference, the adjusted hazard ratio (HR) for 1VD was 1.86, 95% confidence interval (CI) 0.94 to 3.68, P = .073; 2VD: HR 2.13, 95% CI 1.10 to 4.12, P = .025; 3VD: HR 4.00, 95% CI 2.06 to 7.76, P < .001. Using moderate ischemia as the reference, the HR for severe ischemia was 0.84, 95% CI 0.54 to 1.30, P = .427.
CONCLUSION


Among ISCHEMIA-CKD participants randomized to the invasive strategy, extent of CAD predicted D/MI whereas severity of ischemia did not.",2021,"Using moderate ischemia as the reference, the HR for severe ischemia was 0.84, 95% CI 0.54-1.30, p=0.427.
CONCLUSION


Among ISCHEMIA-CKD participants randomized to the invasive strategy, extent of CAD predicted D/MI whereas severity of ischemia did not.","['Of the 388 participants, 307 (79.1%) had complete coronary angiography and stress testing data', 'patients with advanced chronic kidney disease (CKD', 'Participants randomized to invasive management with available data on coronary angiography and stress testing were included']",[],"['severe ischemia', 'D/MI', 'risk of D/MI (p<0.001), while ischemia severity', 'Ischemia severity']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",388.0,0.154644,"Using moderate ischemia as the reference, the HR for severe ischemia was 0.84, 95% CI 0.54-1.30, p=0.427.
CONCLUSION


Among ISCHEMIA-CKD participants randomized to the invasive strategy, extent of CAD predicted D/MI whereas severity of ischemia did not.","[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Bainey', 'Affiliation': 'Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada. Electronic address: kevin.bainey@albertahealthservices.ca.'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': 'National Heart Lung and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Dennis F', 'Initials': 'DF', 'LastName': 'Kunichoff', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Anthopolos', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Chernyavskiy', 'Affiliation': 'E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation (E.Meshalkin NMRC), Novosibirsk, Russia.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Juan-Manuel', 'Initials': 'JM', 'LastName': 'Lopez-Quijano', 'Affiliation': 'Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosí, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Escobedo', 'Affiliation': 'Instituto Mexicano del Seguro Social, Mexico City, Mexico.'}, {'ForeName': 'Kian Keong', 'Initials': 'KK', 'LastName': 'Poh', 'Affiliation': 'National University Heart Center Singapore and Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Ruben B', 'Initials': 'RB', 'LastName': 'Ramos', 'Affiliation': 'Hospital de Santa Marta, Lisboa, Portugal.'}, {'ForeName': 'Eduardo G', 'Initials': 'EG', 'LastName': 'Lima', 'Affiliation': 'Heart Institute, InCor-HCFMUSP, Sao Paulo, Brazil.'}, {'ForeName': 'Herwig', 'Initials': 'H', 'LastName': 'Schuchlenz', 'Affiliation': 'oLKH Graz II, Department fuer Kardiologie und Intensivmedizin, Graz, Austria.'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY; Columbia University Medical Center/New York-Presbyterian Hospital, New York, NY; St Francis Hospital, Roslyn, NY.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute and Duke University, Durham, NC.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Saint Luke's Mid America Heart Institute/University of Missouri - Kansas City (UMKC), Kansas City, MO.""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2021.09.008']
1753,34582548,A lifestyle intervention with an energy-restricted Mediterranean diet and physical activity enhances HDL function: a substudy of the PREDIMED-Plus randomized controlled trial.,"BACKGROUND


Consumption of a Mediterranean diet, adequate levels of physical activity, and energy-restricted lifestyle interventions have been individually associated with improvements in HDL functions. Evidence of intensive interventions with calorie restriction and physical activity is, however, scarce.
OBJECTIVES


To determine whether an intensive lifestyle intervention with an energy-restricted Mediterranean diet plus physical activity enhanced HDL function compared to a non-hypocaloric Mediterranean eating pattern without physical activity.
METHODS


In 391 older adults with metabolic syndrome (mean age, 65 years; mean BMI, 33.3 kg/m2) from 1 of the Prevención con Dieta Mediterránea-Plus trial centers, we evaluated the impact of a 6-month intervention with an energy-restricted Mediterranean diet plus physical activity (intensive lifestyle; n = 190) relative to a nonrestrictive Mediterranean diet without physical activity (control; n = 201) on a set of HDL functional traits. These included cholesterol efflux capacity, HDL oxidative/inflammatory index, HDL oxidation, and levels of complement component 3, serum amyloid A, sphingosine-1-phosphate, triglycerides, and apolipoproteins A-I, A-IV, C-III, and E in apoB-depleted plasma.
RESULTS


The intensive-lifestyle intervention participants displayed greater 6-month weight reductions (-3.83 kg; 95% CI: -4.57 to -3.09 kg) but no changes in HDL cholesterol compared with control-diet participants. Regarding HDL functional traits, the intensive lifestyle decreased triglyceride levels (-0.15 mg/g protein; 95% CI: -0.29 to -0.014 mg/g protein) and apoC-III (-0.11 mg/g protein; 95% CI: -0.18 to -0.026 mg/g protein) compared to the control diet, with weight loss being the essential mediator (proportions of mediation were 77.4% and 72.1% for triglycerides and apoC-III levels in HDL, respectively).
CONCLUSIONS


In older adults with metabolic syndrome, an energy-restricted Mediterranean diet plus physical activity improved the HDL triglyceride metabolism compared with a nonrestrictive Mediterranean diet without physical activity. This trial is registered at isrctn.com as ISRCTN89898870.",2021,The intensive-lifestyle intervention participants displayed greater 6-month weight reductions (-3.83 kg; 95% CI: -4.57 to -3.09 kg) but no changes in HDL cholesterol compared with control-diet participants.,"['older adults with metabolic syndrome', '391 older adults with metabolic syndrome (mean age, 65 years; mean BMI, 33.3\xa0kg/m2) from 1 of the Prevención con Dieta Mediterránea-Plus trial centers']","['lifestyle intervention with an energy-restricted Mediterranean diet and physical activity enhances HDL function', 'energy-restricted Mediterranean diet plus physical activity (intensive lifestyle; n\xa0=\xa0190) relative to a nonrestrictive Mediterranean diet without physical activity (control; n\xa0=\xa0201) on a set of HDL functional traits', 'intensive lifestyle intervention with an energy-restricted Mediterranean diet plus physical activity enhanced HDL function']","['HDL cholesterol', 'HDL triglyceride metabolism', 'triglyceride levels', '6-month weight reductions', 'cholesterol efflux capacity, HDL oxidative/inflammatory index, HDL oxidation, and levels of complement component 3, serum amyloid A, sphingosine-1-phosphate, triglycerides, and apolipoproteins A-I, A-IV, C-III, and E in apoB-depleted plasma']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0062152', 'cui_str': 'High density lipoprotein triglyceride'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009506', 'cui_str': 'Complement component C3'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",391.0,0.0274387,The intensive-lifestyle intervention participants displayed greater 6-month weight reductions (-3.83 kg; 95% CI: -4.57 to -3.09 kg) but no changes in HDL cholesterol compared with control-diet participants.,"[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Sanllorente', 'Affiliation': 'Cardiovascular Risk and Nutrition Research Group, Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'María Trinidad', 'Initials': 'MT', 'LastName': 'Soria-Florido', 'Affiliation': 'Biomedical Nutrition, Pure and Applied Biochemistry, Lund University, Lund, Sweden.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'Cardiovascular Risk and Nutrition Research Group, Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Lassale', 'Affiliation': 'Cardiovascular Risk and Nutrition Research Group, Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Consorcio Centro de Investigación Biomédica En Red (CIBER), M.P. Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'Consorcio Centro de Investigación Biomédica En Red (CIBER), M.P. Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Subirana', 'Affiliation': 'Consorcio Centro de Investigación Biomédica En Red (CIBER), M.P. Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Consorcio Centro de Investigación Biomédica En Red (CIBER), M.P. Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Consorcio Centro de Investigación Biomédica En Red (CIBER), M.P. Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'Consorcio Centro de Investigación Biomédica En Red (CIBER), M.P. Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'Consorcio Centro de Investigación Biomédica En Red (CIBER), M.P. Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Hernáez', 'Affiliation': 'Consorcio Centro de Investigación Biomédica En Red (CIBER), M.P. Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'Cardiovascular Risk and Nutrition Research Group, Hospital del Mar Medical Research Institute, Barcelona, Spain.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab246']
1754,34600602,"Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study.","BACKGROUND


The majority of patients with metastatic castration-resistant prostate cancer (mCRPC) will have disease progression of a uniformly fatal disease. mCRPC is driven by both activated androgen receptors and elevated intratumoural androgens; however, the current standard of care is therapy that targets a single androgen signalling mechanism. We aimed to investigate the combination treatment using apalutamide plus abiraterone acetate, each of which suppresses the androgen signalling axis in a different way, versus standard care in mCRPC.
METHODS


ACIS was a randomised, placebo-controlled, double-blind, phase 3 study done at 167 hospitals in 17 countries in the USA, Canada, Mexico, Europe, the Asia-Pacific region, Africa, and South America. We included chemotherapy-naive men (aged ≥18 years) with mCRPC who had not been previously treated with androgen biosynthesis signalling inhibitors and were receiving ongoing androgen deprivation therapy, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and a Brief Pain Inventory-Short Form question 3 (ie, worst pain in the past 24 h) score of 3 or lower. Patients were randomly assigned (1:1) via a centralised interactive web response system with a permuted block randomisation scheme (block size 4) to oral apalutamide 240 mg once daily plus oral abiraterone acetate 1000 mg once daily and oral prednisone 5 mg twice daily (apalutamide plus abiraterone-prednisone group) or placebo plus abiraterone acetate and prednisone (abiraterone-prednisone group), in 28-day treatment cycles. Randomisation was stratified by presence or absence of visceral metastases, ECOG performance status, and geographical region. Patients, the investigators, study team, and the sponsor were masked to group assignments. An independent data-monitoring committee continually monitored data to ensure ongoing patient safety, and reviewed efficacy data. The primary endpoint was radiographic progression-free survival assessed in the intention-to-treat population. Safety was reported for all patients who received at least one dose of study drug. This study is completed and no longer recruiting and is registered with ClinicalTrials.gov, number NCT02257736.
FINDINGS


982 men were enrolled and randomly assigned from Dec 10, 2014 to Aug 30, 2016 (492 to apalutamide plus abiraterone-prednisone; 490 to abiraterone-prednisone). At the primary analysis (median follow-up 25·7 months [IQR 23·0-28·9]), median radiographic progression-free survival was 22·6 months (95% CI 19·4-27·4) in the apalutamide plus abiraterone-prednisone group versus 16·6 months (13·9-19·3) in the abiraterone-prednisone group (hazard ratio [HR] 0·69, 95% CI 0·58-0·83; p<0·0001). At the updated analysis (final analysis for overall survival; median follow-up 54·8 months [IQR 51·5-58·4]), median radiographic progression-free survival was 24·0 months (95% CI 19·7-27·5) versus 16·6 months (13·9-19·3; HR 0·70, 95% CI 0·60-0·83; p<0·0001). The most common grade 3-4 treatment-emergent adverse event was hypertension (82 [17%] of 490 patients receiving apalutamide plus abiraterone-prednisone and 49 [10%] of 489 receiving abiraterone-prednisone). Serious treatment-emergent adverse events occurred in 195 (40%) patients receiving apalutamide plus abiraterone-prednisone and 181 (37%) patients receiving abiraterone-prednisone. Drug-related treatment-emergent adverse events with fatal outcomes occurred in three (1%) patients in the apalutamide plus abiraterone-prednisone group (2 pulmonary embolism, 1 cardiac failure) and five (1%) patients in the abiraterone-prednisone group (1 cardiac failure and 1 cardiac arrest, 1 mesenteric arterial occlusion, 1 seizure, and 1 sudden death).
INTERPRETATION


Despite the use of an active and established therapy as the comparator, apalutamide plus abiraterone-prednisone improved radiographic progression-free survival. Additional studies to identify subgroups of patients who might benefit the most from combination therapy are needed to further refine the treatment of mCRPC.
FUNDING


Janssen Research & Development.",2021,Serious treatment-emergent adverse events occurred in 195 (40%) patients receiving apalutamide plus abiraterone-prednisone and 181 (37%) patients receiving abiraterone-prednisone.,"['metastatic, castration-resistant prostate cancer (ACIS', '167 hospitals in 17 countries in the USA, Canada, Mexico, Europe, the Asia-Pacific region, Africa, and South America', 'patients with metastatic castration-resistant prostate cancer (mCRPC', 'naive men (aged ≥18 years) with mCRPC who had not been previously treated with androgen biosynthesis signalling inhibitors and were receiving ongoing androgen deprivation therapy, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and a Brief Pain Inventory-Short Form question 3 (ie, worst pain in the past 24 h) score of 3 or lower', '490 patients receiving', '982 men were enrolled and randomly assigned from Dec 10, 2014 to Aug 30, 2016 (492 to']","['apalutamide plus abiraterone acetate', 'abiraterone-prednisone', 'chemotherapy', 'Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone', 'apalutamide plus abiraterone-prednisone; 490 to abiraterone-prednisone', 'centralised interactive web response system with a permuted block randomisation scheme (block size 4) to oral apalutamide 240 mg once daily plus oral abiraterone acetate 1000 mg once daily and oral prednisone 5 mg twice daily (apalutamide plus abiraterone-prednisone group) or placebo plus abiraterone acetate and prednisone (abiraterone-prednisone group', 'placebo', 'apalutamide plus abiraterone-prednisone']","['median radiographic progression-free survival', 'Safety', 'radiographic progression-free survival', 'Serious treatment-emergent adverse events', 'cardiac failure and 1 cardiac arrest, 1 mesenteric arterial occlusion, 1 seizure, and 1 sudden death']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C1533720', 'cui_str': 'Prednisone 5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0151815', 'cui_str': 'Mesenteric arterial occlusion'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}]",982.0,0.602633,Serious treatment-emergent adverse events occurred in 195 (40%) patients receiving apalutamide plus abiraterone-prednisone and 181 (37%) patients receiving abiraterone-prednisone.,"[{'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, QC, Canada. Electronic address: fred.saad@umontreal.ca.""}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'Athens Medical Center, Dept of GU Oncology, Athens, Greece.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Flaig', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Franke', 'Affiliation': 'ONCOSITE, Hospital Unimed Noroeste, Ijuí, Brazil.'}, {'ForeName': 'Oscar B', 'Initials': 'OB', 'LastName': 'Goodman', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, US Oncology Network, Las Vegas, NV, USA.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Georges Pompidou Hospital, University of Paris, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Steuber', 'Affiliation': 'Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Toho University Sakura Medical Center, Chiba, Japan.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Kesav', 'Initials': 'K', 'LastName': 'Yeruva', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'De Porre', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Brookman-May', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA; Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Jinhui', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'Shibu', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Bevans', 'Affiliation': 'Janssen Global Services, Horsham, PA, USA.'}, {'ForeName': 'Suneel D', 'Initials': 'SD', 'LastName': 'Mundle', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'McCarthy', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Dana E', 'Initials': 'DE', 'LastName': 'Rathkopf', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00402-2']
1755,34605947,Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial.,"PURPOSE


Investigate safety and tolerability of adrecizumab, a humanized monoclonal adrenomedullin antibody, in septic shock patients with high adrenomedullin.
METHODS


Phase-2a, double-blind, randomized, placebo-controlled biomarker-guided trial with a single infusion of adrecizumab (2 or 4 mg/kg b.w.) compared to placebo. Patients with adrenomedullin above 70 pg/mL, < 12 h of vasopressor start for septic shock were eligible. Randomization was 1:1:2. Primary safety (90-day mortality, treatment emergent adverse events (TEAE)) and tolerability (drug interruption, hemodynamics) endpoints were recorded. Efficacy endpoints included the Sepsis Support Index (SSI, reflecting ventilator- and shock-free days alive), change in Sequential-related Organ Failure Assessment (SOFA) and 28-day mortality.
RESULTS


301 patients were enrolled (median time of 8.5 h after vasopressor start). Adrecizumab was well tolerated (one interruption, no hemodynamic alteration) with no differences in frequency and severity in TEAEs between treatment arms (TEAE of grade 3 or higher: 70.5% in the adrecizumab group and 71.1% in the placebo group) nor in 90-day mortality. Difference in change in SSI between adrecizumab and placebo was 0.72 (CI -1.93-0.49, p = 0.24). Among various secondary endpoints, delta SOFA score (defined as maximum versus minimum SOFA) was more pronounced in the adrecizumab combined group compared to placebo [difference at 0.76 (95% CI 0.18-1.35); p = 0.007]. 28-day mortality in the adrecizumab group was 23.9% and 27.7% in placebo with a hazard ratio of 0.84 (95% confidence interval 0.53-1.31, log-rank p = 0.44).
CONCLUSIONS


Overall, we successfully completed a randomized trial evaluating selecting patients for enrolment who had a disease-related biomarker. There were no overt signals of harm with using two doses of the adrenomedullin antibody adrecizumab; however, further randomized controlled trials are required to confirm efficacy and safety of this agent in septic shock patients.",2021,"There were no overt signals of harm with using two doses of the adrenomedullin antibody adrecizumab; however, further randomized controlled trials are required to confirm efficacy and safety of this agent in septic shock patients.","['Patients with adrenomedullin above 70\xa0pg/mL,\u2009<\u200912\xa0h of vasopressor start for septic shock were eligible', 'septic shock patients with high adrenomedullin', 'septic shock patients', '301 patients were enrolled (median time of 8.5\xa0h after vasopressor start', 'patients for enrolment who had a disease-related biomarker']","['Adrecizumab', 'placebo', 'non-neutralizing adrenomedullin antibody adrecizumab (HAM8101', 'adrecizumab']","['Sepsis Support Index (SSI, reflecting ventilator- and shock-free days alive), change in Sequential-related Organ Failure Assessment (SOFA) and 28-day mortality', '28-day mortality', 'Primary safety (90-day mortality, treatment emergent adverse events (TEAE)) and tolerability (drug interruption, hemodynamics) endpoints', 'Safety and tolerability', 'delta SOFA score', '90-day mortality', 'tolerated', 'SSI', 'frequency and severity in TEAEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0215825', 'cui_str': 'ADM(1-52)'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0215825', 'cui_str': 'ADM(1-52)'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",301.0,0.57521,"There were no overt signals of harm with using two doses of the adrenomedullin antibody adrecizumab; however, further randomized controlled trials are required to confirm efficacy and safety of this agent in septic shock patients.","[{'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Laterre', 'Affiliation': 'Cliniques Universitaires Saint-Luc, (UCL Bruxelles), Avenue Hippocrate 10, 1200, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Klinik fur Operative Intensivmedizin und Intermediate Care, Universitätsklinikum Aachen, Pauwelsstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Wittebole', 'Affiliation': 'Critical Care Department, Cliniques Universitaires St Luc, UC Louvain, Avenue Hipporcrate 10, 1200, Brussels, Belgium.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'Faculté de Médecine, Service de Médecine Intensive-Réanimation, Université de Strasbourg (UNISTRA), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Dugernier', 'Affiliation': 'Clinique St. Pierre, Avenue Reine Fabiola 9, 1340, Ottignies, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Huberlant', 'Affiliation': 'Intensive Care, CH Jolimont, Hospitalier de Jolimont, Rue Ferrer 159, 7100, Haine Saint Paul, Belgium.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schuerholz', 'Affiliation': 'Klinik und Poliklinik fur Anaesthesiologie und Intensivtherapie, Universitätsmedizin Rostock, Schillingallee 35, 18057, Rostock, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'François', 'Affiliation': 'Réanimation Polyvalente and Inserm CIC1435 & UMR1092, CHU de Limoges, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'CHU de Nantes, Médecine Intensive Réanimation, 30 Bd. Jean Monnet, 44093, Nantes Cedex 1, France.'}, {'ForeName': 'Albertus', 'Initials': 'A', 'LastName': 'Beishuizen', 'Affiliation': 'Intensive Care Center, Medisch Spectrum Twente, Koningsplein 1, 7512KZ, Enschede, The Netherlands.'}, {'ForeName': 'Haikel', 'Initials': 'H', 'LastName': 'Oueslati', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75010, Paris, France.""}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Contou', 'Affiliation': ""CH Victor Dupouy, 69 Rue du Lieutenant-Colonel Prud'hon, 95107, Argenteuil Cedex, France.""}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Hoiting', 'Affiliation': 'Canisius-Wilhelmina-Ziekenhuis (CWZ), Weg door Jonkerbosch 100, 6532 SZ, Nijmegen, The Netherlands.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Lacherade', 'Affiliation': 'CHD-Vendée, Médecine Intensive Réanimation, Boulevard Stéphane Moreau, 85000, La Roche-Sur-Yon, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chousterman', 'Affiliation': 'Université de Paris, U942 Inserm, MASCOT, Hôpitaux Universitaires Saint-Louis- Lariboisière, Fernand-Widal, 2, rue Ambroise-Paré, 75475, Paris Cedex 10, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Pottecher', 'Affiliation': ""Fédération de Médecine Translationnelle de Strasbourg, Hôpitaux Universitaires de Strasbourg, Service d'Anesthésie-Réanimation & Médecine Péri-Opératoire-Université de Strasbourg, EA3072, Strasbourg, France.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Godet', 'Affiliation': 'Département Anesthésie et Réanimation, CHU de Clermont-Ferrand, Pôle de Médecine Péri-opératoire, Clermont-Ferrand, France.'}, {'ForeName': 'Mahir', 'Initials': 'M', 'LastName': 'Karakas', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Helms', 'Affiliation': 'Faculté de Médecine, Service de Médecine Intensive-Réanimation, Université de Strasbourg (UNISTRA), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': 'Adrenomed AG, Neuendorfstr. 15a, 16761, Hennigsdorf, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Zimmermann', 'Affiliation': 'Adrenomed AG, Neuendorfstr. 15a, 16761, Hennigsdorf, Germany.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Richter', 'Affiliation': 'Adrenomed AG, Neuendorfstr. 15a, 16761, Hennigsdorf, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hartmann', 'Affiliation': 'Adrenomed AG, Neuendorfstr. 15a, 16761, Hennigsdorf, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Pars', 'Affiliation': 'Adrenomed AG, Neuendorfstr. 15a, 16761, Hennigsdorf, Germany.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mebazaa', 'Affiliation': 'Université de Paris, U942 Inserm, MASCOT, APHP, Fédération Hospitalo-Universitaire PROMICE, Hôpitaux Universitaires Saint-Louis-Lariboisière, Fernand-Widal, 2, Rue Ambroise-Paré, 75475, Paris Cedex 10, France. alexandre.mebazaa@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-021-06537-5']
1756,34602110,Impact of ACE2 genetic variant on antidepressant efficacy of SSRIs.,"Identification of a new axis of angiotensin-converting enzyme 2 (ACE2)/angiotensin (1-7)/Mas receptor, in the renin-angiotensin system (RAS), has opened a new insight regarding the role of RAS and angiotensin in higher brain functions. ACE2 catabolizes angiotensin II and produces angiotensin (1-7), an agonist of Mas receptor. Mice lacking the Mas receptor (angiotensin 1-7 receptor) exhibit anxiety-like behaviours. The present study was conducted to test the hypothesis of the involvement of ACE2 genetic variant (G8790A) on response to selective serotonin reuptake inhibitors (SSRIs). In a randomised control trial, 200 newly diagnosed Iranian patients with major depressive disorder completed 6 weeks of fluoxetine or sertraline treatment. Patients with a reduction of 50% or more in the Hamilton Rating Scale for Depression score were considered responsive to treatment. G8790A polymorphism was determined in extracted DNAs using restriction fragment length polymerase chain reaction method. Our results show that the A allele and AA and GA genotypes were significantly associated with better response to SSRIs (p = 0.008; OR = 3.4; 95% CI = 1.4-8.5 and p = 0.027; OR = 3.3, 95% CI = 1.2-9.2, respectively). Moreover, patients with GA and AA genotypes responded significantly better to sertraline (p = 0.0002; OR = 9.1; 95% CI = 2.4-33.7). The A allele was significantly associated with better response to sertraline (p = 0.0001; OR = 7.6; 95% CI = 2.5-23.3). In conclusion, our results confirm the role of G8790A in response to some SSRIs.",2021,"The A allele as well as AA and GA genotypes were significantly associated with better response to SSRIs (P=0.008; OR= 3.4; 95%CI=1.4-8.5 and P=0.027; OR=3.3, 95%CI=1.2-9.2 respectively).",['two hundred newly diagnosed Iranian patients with major depressive disorder (MDD) completed 6 weeks of'],"['ACE 2 catabolizes angiotensin II and produces angiotensin', 'fluoxetine or sertraline treatment']",['Hamilton Rating Scale for Depression (HAM-D) score'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",200.0,0.0341226,"The A allele as well as AA and GA genotypes were significantly associated with better response to SSRIs (P=0.008; OR= 3.4; 95%CI=1.4-8.5 and P=0.027; OR=3.3, 95%CI=1.2-9.2 respectively).","[{'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Firouzabadi', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Farshadfar', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maral', 'Initials': 'M', 'LastName': 'Haghnegahdar', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alavi-Shoushtari', 'Affiliation': 'Department of Psychiatry, UCLA-Kern, Bakersfield, CA, USA.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Ghanbarinejad', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Acta neuropsychiatrica,['10.1017/neu.2021.32']
1757,34571011,Effects of Wii Fit Rehabilitation on Lower Extremity Functional Status in Adults With Severe Burns: A Randomized Controlled Trial.,"OBJECTIVES


To investigate the effects of the Wii Fit rehabilitation program in addition to a standard physical therapy program (SPTP) on lower extremity functional status and functional mobility in adults with severe burns after hospital discharge.
DESIGN


A single-blinded, parallel groups, randomized controlled trial.
SETTINGS


Outpatient rehabilitation center.
PARTICIPANTS


Thirty-four patients (N=34), aged 31.3±7.3 years old, with lower extremity deep partial-thickness and full-thickness burn and total body surface area of more than 40% were allocated randomly into 2 equal groups.
INTERVENTIONS


The Wii Fit group received the Wii Fit program for 30 minutes in addition to SPTP for 60 minutes, whereas the SPTP group received SPTP only. The intervention was 3 sessions a week for 12 weeks.
MAIN OUTCOME MEASURES


The primary outcome measurements were the functional status and functional mobility, which were assessed by the high mobility assessment tool, Lower Limb Functional Index, and timed Up and Go test. The secondary outcomes included exercise capacity, muscle strength, and balance measured by the 6-minute walk test, isokinetic muscle strength assessment, and stability index. All the outcome measures were collected at the baseline and after 12 weeks of intervention.
RESULTS


After 12 weeks of intervention, there were statistically significant differences between groups in all outcome measures in favor of the Wii Fit group (P<.001). Also, statistically significant differences were found in all the measured outcomes after 12 weeks of intervention in each group (P<.05).
CONCLUSIONS


Patients with lower extremity burns who received the Wii Fit program in addition to the SPTP had better improvements in lower limb functional status, functional mobility, exercise capacity, muscle strength, and balance than patients who received SPTP alone. The Wii Fit program was a useful adjunctive therapy in rehabilitating adults with lower extremity burn injury.",2021,"After 12 weeks of intervention, there were statistically significant differences between groups in all outcome measures in favor of the Wii Fit group (P < 0.001).","['Patients with lower extremity burns', 'adults with severe burns after hospital discharge', 'rehabilitating adults with lower extremity burn injury', 'Outpatient rehabilitation center', 'Thirty-four patients, 31.3±7.3 years old, with lower extremity deep partial-thickness and full-thickness burn and total body surface area of more than 40', 'Adults with Severe Burns']","['Wii Fit program', 'standard physical therapy program (SPTP', 'Wii Fit Rehabilitation', 'Wii Fit rehabilitation program']","['exercise capacity, muscle strength, and balance measured by the six-minute walk test, isokinetic muscle strength assessment, and stability index', 'lower limb functional status, functional mobility, exercise capacity, muscle strength and balance', 'lower extremity functional status and functional mobility', 'functional status and functional mobility, which were assessed by the high mobility assessment tool, Lower Limb Functional Index, and Timed-up and go test', 'Lower Extremity Functional Status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness'}, {'cui': 'C0433445', 'cui_str': 'Third degree burn injury'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0483487,"After 12 weeks of intervention, there were statistically significant differences between groups in all outcome measures in favor of the Wii Fit group (P < 0.001).","[{'ForeName': 'Maged A', 'Initials': 'MA', 'LastName': 'Basha', 'Affiliation': 'Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Buraidah, Qassim, Saudi Arabia; Department of Physical Therapy, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt. Electronic address: M.Basha@qu.edu.sa.'}, {'ForeName': 'Nabil M', 'Initials': 'NM', 'LastName': 'Abdel-Aal', 'Affiliation': 'Department of Physical Therapy for Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Fatma Alzahraa H', 'Initials': 'FAH', 'LastName': 'Kamel', 'Affiliation': 'Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Buraidah, Qassim, Saudi Arabia; Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.08.020']
1758,34570916,Randomised clinical trial: semaglutide versus placebo reduced liver steatosis but not liver stiffness in subjects with non-alcoholic fatty liver disease assessed by magnetic resonance imaging.,"BACKGROUND


Glucagon-like peptide-1 receptor agonists may be a treatment option in patients with non-alcoholic fatty liver disease (NAFLD).
AIMS


To investigate the effects of semaglutide on liver stiffness and liver fat in subjects with NAFLD using non-invasive magnetic resonance imaging (MRI) methods.
METHODS


This randomised, double-blind, placebo-controlled trial enrolled subjects with liver stiffness 2.50-4.63 kPa by magnetic resonance elastography (MRE) and liver steatosis ≥10% by MRI proton density fat fraction (MRI-PDFF). The primary endpoint was change from baseline to week 48 in liver stiffness assessed by MRE.
RESULTS


Sixty-seven subjects were randomised to once-daily subcutaneous semaglutide 0.4 mg (n = 34) or placebo (n = 33). Change from baseline in liver stiffness was not significantly different between semaglutide and placebo at week 48 (estimated treatment ratio 0.96 (95% CI 0.89, 1.03; P = 0.2798); significant differences in liver stiffness were not observed at weeks 24 or 72. Reductions in liver steatosis were significantly greater with semaglutide (estimated treatment ratios: 0.70 [0.59, 0.84], P = 0.0002; 0.47 [0.36, 0.60], P < 0.0001; and 0.50 [0.39, 0.66], P < 0.0001) and more subjects achieved a ≥ 30% reduction in liver fat content with semaglutide at weeks 24, 48 and 72, (all P < 0.001). Decreases in liver enzymes, body weight and HbA 1c  were also observed with semaglutide.
CONCLUSIONS


The change in liver stiffness in subjects with NAFLD was not significantly different between semaglutide and placebo. However, semaglutide significantly reduced liver steatosis compared with placebo which, together with improvements in liver enzymes and metabolic parameters, suggests a positive impact on disease activity and metabolic profile. ClinicalTrials.gov identifier: NCT03357380.",2021,"Change from baseline in liver stiffness was not significantly different between semaglutide and placebo at week 48 (estimated treatment ratio 0.96 (95% CI 0.89, 1.03; P = 0.2798); significant differences in liver stiffness were not observed at weeks 24 or 72.","['controlled trial enrolled subjects with liver stiffness 2.50-4.63\xa0kPa by magnetic resonance elastography (MRE) and liver steatosis ≥10% by MRI proton density fat fraction (MRI-PDFF', 'patients with non-alcoholic fatty liver disease (NAFLD', 'Sixty-seven subjects', 'subjects with NAFLD using non-invasive magnetic resonance imaging (MRI) methods']","['Semaglutide versus placebo', 'semaglutide', 'placebo']","['liver enzymes, body weight and HbA 1c', 'liver stiffness and liver fat', 'liver steatosis', 'liver enzymes and metabolic parameters', 'liver fat content', 'liver stiffness', 'liver stiffness assessed by MRE', 'disease activity and metabolic profile']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",67.0,0.54308,"Change from baseline in liver stiffness was not significantly different between semaglutide and placebo at week 48 (estimated treatment ratio 0.96 (95% CI 0.89, 1.03; P = 0.2798); significant differences in liver stiffness were not observed at weeks 24 or 72.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Flint', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Grit', 'Initials': 'G', 'LastName': 'Andersen', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hockings', 'Affiliation': 'Antaros Medical, BioVenture Hub, Mölndal, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Johansson', 'Affiliation': 'Antaros Medical, BioVenture Hub, Mölndal, Sweden.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Morsing', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Sundby Palle', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vogl', 'Affiliation': 'University Hospital, Frankfurt, Germany.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'University of California San Diego School of Medicine, San Diego, California, USA.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16608']
1759,34579142,"Effect of the Lifestyle, Exercise, and Nutrition (LEAN) Study on Long-Term Weight Loss Maintenance in Women with Breast Cancer.","Lifestyle interventions among breast cancer survivors with obesity have demonstrated successful short-term weight loss, but data on long-term weight maintenance are limited. We evaluated long-term weight loss maintenance in 100 breast cancer survivors with overweight/obesity in the efficacious six-month Lifestyle, Exercise, and Nutrition (LEAN) Study (intervention = 67; usual care = 33). Measured baseline and six-month weights were available for 92 women. Long-term weight data were obtained from electronic health records. We assessed weight trajectories between study completion (2012-2013) and July 2019 using growth curve analyses. Over up to eight years (mean = 5.9, SD = 1.9) of post-intervention follow-up, both the intervention ( n  = 60) and usual care ( n  = 32) groups declined in body weight. Controlling for body weight at study completion, the yearly weight loss rate in the intervention and usual care groups was -0.20 kg (-0.2%/year) (95% CI: 0.06, 0.33,  p  = 0.004) and -0.32 kg (-0.4%/year) (95% CI: 0.12, 0.53,  p  = 0.002), respectively; mean weight change did not differ between groups ( p  = 0.31). It was encouraging that both groups maintained their original intervention period weight loss (6% intervention, 2% usual care) and had modest weight loss during long-term follow-up. Breast cancer survivors in the LEAN Study, regardless of randomization, avoided long-term weight gain following study completion.",2021,"Controlling for body weight at study completion, the yearly weight loss rate in the intervention and usual care groups was -0.20 kg (-0.2%/year) (95% CI: 0.06, 0.33,  p  = 0.004) and -0.32 kg","['Breast cancer survivors', 'Women with Breast Cancer', 'breast cancer survivors with obesity', '100 breast cancer survivors with overweight/obesity in the efficacious six-month Lifestyle, Exercise, and Nutrition (LEAN) Study (intervention = 67; usual care = 33']","['Lifestyle interventions', 'Lifestyle, Exercise, and Nutrition (LEAN) Study on Long-Term Weight Loss Maintenance']","['mean weight change', 'weight loss', 'body weight', 'yearly weight loss rate', 'weight trajectories']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}]",,0.0301083,"Controlling for body weight at study completion, the yearly weight loss rate in the intervention and usual care groups was -0.20 kg (-0.2%/year) (95% CI: 0.06, 0.33,  p  = 0.004) and -0.32 kg","[{'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Lisevick', 'Affiliation': 'Frank H. Netter MD School of Medicine, Quinnipiac University, Hamden, CT 06518, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': 'Yale School of Public Health, Yale University, New Haven, CT 06510, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Harrigan', 'Affiliation': 'Yale School of Public Health, Yale University, New Haven, CT 06510, USA.'}, {'ForeName': 'Fangyong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Yale School of Public Health, Yale University, New Haven, CT 06510, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sanft', 'Affiliation': 'Yale Cancer Center, New Haven, CT 06510, USA.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Fogarasi', 'Affiliation': 'Frank H. Netter MD School of Medicine, Quinnipiac University, Hamden, CT 06518, USA.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Yale School of Public Health, Yale University, New Haven, CT 06510, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ferrucci', 'Affiliation': 'Yale School of Public Health, Yale University, New Haven, CT 06510, USA.'}]",Nutrients,['10.3390/nu13093265']
1760,34579131,Effects of Sodium Selenite Injection on Serum Metabolic Profiles in Women Diagnosed with Breast Cancer-Related Lymphedema-Secondary Analysis of a Randomized Placebo-Controlled Trial Using Global Metabolomics.,"In our previous study, intravenous (IV) injection of selenium alleviated breast cancer-related lymphedema (BCRL). This secondary analysis aimed to explore the metabolic effects of selenium on patients with BCRL. Serum samples of the selenium-treated (SE,  n  = 15) or the placebo-controlled (CTRL,  n  = 14) groups were analyzed by ultra-high-performance liquid chromatography with Q-Exactive Orbitrap tandem mass spectrometry (UHPLC-Q-Exactive Orbitrap/MS). The SE group showed a lower ratio of extracellular water to segmental water (ECW/SW) in the affected arm to ECW/SW in the unaffected arm (arm ECW/SW ratio) than the CTRL group. Metabolomics analysis showed a valid classification at 2-weeks and 107 differential metabolites were identified. Among them, the levels of corticosterone, LTB4-DMA, and PGE 3 -which are known anti-inflammatory compounds-were elevated in the SE group. Pathway analysis demonstrated that lipid metabolism (glycerophospholipid metabolism, steroid hormone biosynthesis, or arachidonic acid metabolism), nucleotide metabolism (pyrimidine or purine metabolism), and vitamin metabolism (pantothenate and CoA biosynthesis, vitamin B 6  metabolism, ascorbate and aldarate metabolism) were altered in the SE group compared to the CTRL group. In addition, xanthurenic acid levels were negatively associated with whole blood selenium level (WBSe) and positively associated with the arm ECW/SW. In conclusion, selenium IV injection improved the arm ECW/SW ratio and altered the serum metabolic profiles in patients with BCRL, and improved the anti-inflammatory process in lipid, nucleotide and vitamin pathways, which might alleviate the symptoms of BCRL.",2021,The SE group showed a lower ratio of extracellular water to segmental water (ECW/SW) in the affected arm to ECW/SW in the unaffected arm (arm ECW/SW ratio) than the CTRL group.,"['Women Diagnosed with Breast Cancer-Related Lymphedema-Secondary Analysis of a Randomized', 'patients with BCRL', 'alleviated breast cancer-related lymphedema (BCRL']","['intravenous (IV) injection of selenium', 'Sodium Selenite Injection', 'Placebo', 'selenium', 'placebo']","['lipid metabolism (glycerophospholipid metabolism, steroid hormone biosynthesis, or arachidonic acid metabolism), nucleotide metabolism (pyrimidine or purine metabolism), and vitamin metabolism (pantothenate and CoA biosynthesis, vitamin B 6  metabolism, ascorbate and aldarate metabolism', 'lower ratio of extracellular water to segmental water (ECW/SW', 'whole blood selenium level (WBSe', 'Serum Metabolic Profiles', 'xanthurenic acid levels', 'arm ECW/SW ratio', 'serum metabolic profiles', 'levels of corticosterone, LTB4-DMA, and PGE 3 -which are known anti-inflammatory compounds']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0142923', 'cui_str': 'sodium selenite'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0162448', 'cui_str': 'Phosphoglycerides'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0034284', 'cui_str': 'Pyrimidine'}, {'cui': 'C0034140', 'cui_str': 'Purines'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0178793', 'cui_str': 'pantothenate'}, {'cui': 'C0643042', 'cui_str': ""12-(4'-azido-2'-nitrophenoxy)dodecanoyl-coenzyme A""}, {'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0373721', 'cui_str': 'Selenium measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0078610', 'cui_str': 'Xanthurenic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010124', 'cui_str': 'Corticosterone'}, {'cui': 'C0023546', 'cui_str': 'LTB4'}, {'cui': 'C0013013', 'cui_str': 'Commonwealth of Dominica'}, {'cui': 'C0033559', 'cui_str': 'E series prostaglandin'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0205198', 'cui_str': 'Compound'}]",,0.148265,The SE group showed a lower ratio of extracellular water to segmental water (ECW/SW) in the affected arm to ECW/SW in the unaffected arm (arm ECW/SW ratio) than the CTRL group.,"[{'ForeName': 'Heeju', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, BK21 FOUR Project, College of Human Ecology, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Graduate Program in Biomedical Engineering, College of Medicine, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Yeonhee', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Food and Nutrition, BK21 FOUR Project, College of Human Ecology, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Sohyun', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'Department of Food and Nutrition, BK21 FOUR Project, College of Human Ecology, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Eunjoo', 'Initials': 'E', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation Medicine, College of Medicine, Seoul National University Bundang Hospital, Seoul National University, Seongnam 13620, Korea.'}, {'ForeName': 'Seungmin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, BK21 FOUR Project, College of Human Ecology, Yonsei University, Seoul 03722, Korea.'}]",Nutrients,['10.3390/nu13093253']
1761,34579127,Does the Combined Effect of Resistance Training with EPO and Iron Sulfate Improve Iron Metabolism in Older Individuals with End-Stage Renal Disease?,"We sought to investigate the effects of resistance training (RT) combined with erythropoietin (EPO) and iron sulfate on the hemoglobin, hepcidin, ferritin, iron status, and inflammatory profile in older individuals with end-stage renal disease (ESRD). ESRD patients ( n : 157; age: 66.8 ± 3.6; body mass: 73 ± 15; body mass index: 27 ± 3), were assigned to control (CTL;  n : 76) and exercise groups (RT;  n : 81). The CTL group was divided according to the iron treatment received: without iron treatment (CTL-none;  n  = 19), treated only with iron sulfate or EPO (CTL-EPO or IRON;  n  = 19), and treated with both iron sulfate and EPO (CTL-EPO + IRON;  n  = 76). The RT group followed the same pattern: (RT-none;  n  = 20), (RT-EPO or IRON;  n  = 18), and (RT-EPO + IRON;  n  = 86). RT consisted of 24 weeks/3 days per week at moderate intensity of full-body resistance exercises prior to the hemodialysis section. The RT group, regardless of the iron treatment, improved iron metabolism in older individuals with ESRD. These results provide some clues on the effects of RT and its combination with EPO and iron sulfate in this population, highlighting RT as an important coadjutant in ESRD-iron deficiency.",2021,"The RT group, regardless of the iron treatment, improved iron metabolism in older individuals with ESRD.","['older individuals with ESRD', 'older individuals with end-stage renal disease (ESRD', 'Older Individuals with End-Stage Renal Disease', 'ESRD patients ( n : 157; age: 66.8 ± 3.6; body mass: 73 ± 15; body mass index: 27 ± 3']","['EPO and iron sulfate', 'without iron treatment (CTL-none;  n  = 19), treated only with iron sulfate or EPO (CTL-EPO or IRON;  n  = 19), and treated with both iron sulfate and EPO (CTL-EPO + IRON', 'Resistance Training with EPO and Iron Sulfate', 'CTL', 'resistance training (RT) combined with erythropoietin (EPO) and iron sulfate']","['iron metabolism', 'hemoglobin, hepcidin, ferritin, iron status, and inflammatory profile']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",157.0,0.0129986,"The RT group, regardless of the iron treatment, improved iron metabolism in older individuals with ESRD.","[{'ForeName': 'Hugo de Luca', 'Initials': 'HL', 'LastName': 'Corrêa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Víctor Manuel', 'Initials': 'VM', 'LastName': 'Alfaro-Magallanes', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Sciences (INEF), Universidad Politécnica de Madrid (UPM), 28040 Madrid, Spain.'}, {'ForeName': 'Sting Ray Gouveia', 'Initials': 'SRG', 'LastName': 'Moura', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Fernando Sousa', 'Initials': 'FS', 'LastName': 'Honorato', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Victor Lopes', 'Initials': 'VL', 'LastName': 'Silva', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Artur Temizio Oppelt', 'Initials': 'ATO', 'LastName': 'Raab', 'Affiliation': 'Department of Medicine, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Beatriz Carneiro Habbema', 'Initials': 'BCH', 'LastName': 'Maia', 'Affiliation': 'Department of Medicine, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Isabela Akaishi', 'Initials': 'IA', 'LastName': 'Padula', 'Affiliation': 'Department of Medicine, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Lucas Santos de', 'Initials': 'LS', 'LastName': 'Gusmão Alves', 'Affiliation': 'Department of Medicine, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Rafaela Araújo', 'Initials': 'RA', 'LastName': 'Machado', 'Affiliation': 'Department of Medicine, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Andrea Lucena', 'Initials': 'AL', 'LastName': 'Reis', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Carlos Ernesto Santos', 'Initials': 'CES', 'LastName': 'Ferreira', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Luiz Sinésio da Silva', 'Initials': 'LSDS', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine, Federal University of Tocantins, Para 77402-970, Brazil.'}, {'ForeName': 'Fernanda Silveira', 'Initials': 'FS', 'LastName': 'Tavares', 'Affiliation': 'Department of Medicine, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Rosângela Vieira', 'Initials': 'RV', 'LastName': 'Andrade', 'Affiliation': 'Graduate Program of Genomic Sciences and Biotechnology, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}, {'ForeName': 'Thiago Dos Santos', 'Initials': 'TDS', 'LastName': 'Rosa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brasilia 71966-700, Brazil.'}]",Nutrients,['10.3390/nu13093250']
1762,34579125,The Gut Microbiota during a Behavioral Weight Loss Intervention.,"Altered gut microbiota has been linked to obesity and may influence weight loss. We are conducting an ongoing weight loss trial, comparing daily caloric restriction (DCR) to intermittent fasting (IMF) in adults who are overweight or obese. We report here an ancillary study of the gut microbiota and selected obesity-related parameters at the baseline and after the first three months of interventions. During this time, participants experienced significant improvements in clinical health measures, along with altered composition and diversity of fecal microbiota. We observed significant associations between the gut microbiota features and clinical measures, including weight and waist circumference, as well as changes in these clinical measures over time. Analysis by intervention group found between-group differences in the relative abundance of  Akkermansia  in response to the interventions. Our results provide insight into the impact of baseline gut microbiota on weight loss responsiveness as well as the early effects of DCR and IMF on gut microbiota.",2021,Analysis by intervention group found between-group differences in the relative abundance of  Akkermansia  in response to the interventions.,['adults who are overweight or obese'],['daily caloric restriction (DCR) to intermittent fasting (IMF'],"['clinical health measures', 'relative abundance of  Akkermansia', 'altered composition and diversity of fecal microbiota', 'weight and waist circumference']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1490589', 'cui_str': 'Akkermansia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",,0.0596806,Analysis by intervention group found between-group differences in the relative abundance of  Akkermansia  in response to the interventions.,"[{'ForeName': 'Maggie A', 'Initials': 'MA', 'LastName': 'Stanislawski', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Frank', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Borengasser', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Ostendorf', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ir', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Purevsuren', 'Initials': 'P', 'LastName': 'Jambal', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Bing', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Wayland', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'Siebert', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'MacLean', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Catenacci', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}]",Nutrients,['10.3390/nu13093248']
1763,34578973,The Effect of Caloric Restriction with and without n-3 PUFA Supplementation on Bone Turnover Markers in Blood of Subjects with Abdominal Obesity: A Randomized Placebo-Controlled Trial.,"Weight loss contributes to an increased risk of hip fracture, especially in postmenopausal women. Omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation could diminish the adverse effect of weight loss on bone health. The aim of this randomized, placebo-controlled, double-blind parallel trial was to investigate the effect of caloric restriction and n-3 PUFA supplement intake on osteogenic markers (carboxylated osteocalcin (Gla-OC); procollagen I N-terminal propeptide (PINP)), as well as a bone resorption marker (C-terminal telopeptide of type I collagen (CTX-I)) in a serum of 64 middle aged individuals (BMI 25-40 kg/m 2 ) with abdominal obesity. Bone remodeling, metabolic and inflammatory parameters and adipokines were determined before and after 3 months of an isocaloric diet (2300-2400 kcal/day) or a low-calorie diet (1200 kcal/day for women and 1500 kcal/day for men) along with n-3 PUFA (1.8 g/day) or placebo capsules. CTX-I and adiponectin concentrations were increased following 7% weight loss independently of supplement use. Changes in CTX-I were positively associated with changes in adiponectin level (rho = 0.25,  p  = 0.043). Thus, an increase in serum adiponectin caused by body weight loss could adversely affect bone health. N-3 PUFAs were without effect.",2021,"I were positively associated with changes in adiponectin level (rho = 0.25,  p  = 0.043).","['postmenopausal women', '64 middle aged individuals (BMI 25-40 kg/m 2 ) with abdominal obesity', 'Subjects with Abdominal Obesity']","['isocaloric diet', 'I collagen (CTX-I', 'Placebo', 'caloric restriction and n-3 PUFA supplement intake', 'n-3 PUFA', 'low-calorie diet', 'placebo capsules', 'N-3', 'Omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation', 'Caloric Restriction with and without n-3 PUFA Supplementation', 'placebo']","['serum adiponectin', 'adiponectin level', 'osteogenic markers (carboxylated osteocalcin (Gla-OC); procollagen I N-terminal propeptide (PINP', 'Bone remodeling, metabolic and inflammatory parameters and adipokines', 'bone resorption marker', 'CTX-I and adiponectin concentrations']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",64.0,0.115338,"I were positively associated with changes in adiponectin level (rho = 0.25,  p  = 0.043).","[{'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Razny', 'Affiliation': 'Department of Clinical Biochemistry, Jagiellonian University Medical College, Skawinska 8, 31-066 Krakow, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Goralska', 'Affiliation': 'Department of Clinical Biochemistry, Jagiellonian University Medical College, Skawinska 8, 31-066 Krakow, Poland.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, Tremona Road, Southampton SO16 6YD, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gruca', 'Affiliation': 'Department of Clinical Biochemistry, Jagiellonian University Medical College, Skawinska 8, 31-066 Krakow, Poland.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Childs', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, Tremona Road, Southampton SO16 6YD, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kapusta', 'Affiliation': 'Department of Clinical Biochemistry, Jagiellonian University Medical College, Skawinska 8, 31-066 Krakow, Poland.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Slowinska-Solnica', 'Affiliation': 'Department of Clinical Biochemistry, Jagiellonian University Medical College, Skawinska 8, 31-066 Krakow, Poland.'}, {'ForeName': 'Aldona', 'Initials': 'A', 'LastName': 'Dembinska-Kiec', 'Affiliation': 'Department of Clinical Biochemistry, Jagiellonian University Medical College, Skawinska 8, 31-066 Krakow, Poland.'}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Solnica', 'Affiliation': 'Department of Clinical Biochemistry, Jagiellonian University Medical College, Skawinska 8, 31-066 Krakow, Poland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Malczewska-Malec', 'Affiliation': 'Department of Clinical Biochemistry, Jagiellonian University Medical College, Skawinska 8, 31-066 Krakow, Poland.'}]",Nutrients,['10.3390/nu13093096']
1764,34578969,The Effects of Korean Red Ginseng on Biological Aging and Antioxidant Capacity in Postmenopausal Women: A Double-Blind Randomized Controlled Study.,"Postmenopausal women are vulnerable to aging and oxidative stress due to reduced estrogen. Previous studies have shown that Korean red ginseng (KRG) has beneficial effects on aging and antioxidant capacity. Therefore, we evaluated the effects of KRG on biological aging and antioxidant capacity in postmenopausal women. This study conducted a double-blinded, placebo-controlled clinical trial. The participants were randomly administered KRG or a placebo, and the following metrics were measured: mitochondria DNA (mtDNA) copy number as an indicator of biological aging and, total antioxidant status (TAS) as a marker of antioxidant capacity. Clinical symptoms of fatigue, as measured by the fatigue severity scale, were assessed before and after KRG administration. There were 63 participants, of whom 33 received KRG and 30 received a placebo. The mtDNA copy number (KRG group: 1.58 ± 2.05, placebo group: 0.28 ± 2.36,  p  = 0.023) and TAS (KRG group: 0.11 ± 0.25 mmol/L, placebo group: -0.04 ± 0.16 mmol/L,  p  = 0.011) increased and the fatigue severity scale (KRG group: -7 ± 12, placebo group: -1 ± 11,  p  = 0.033) decreased significantly more in the KRG group than the placebo group. KRG significantly increased the mtDNA copy number, total antioxidant status, and improved symptoms of fatigue in postmenopausal women.",2021,"The mtDNA copy number (KRG group: 1.58 ± 2.05, placebo group: 0.28 ± 2.36,  p  = 0.023) and TAS (KRG group: 0.11 ± 0.25 mmol/L, placebo group: -0.04 ± 0.16 mmol/L,  p  = 0.011) increased and the fatigue severity scale (KRG group: -7 ± 12, placebo group: -1 ± 11,  p  = 0.033) decreased significantly more in the KRG group than the placebo group.","['postmenopausal women', 'Postmenopausal Women', 'Postmenopausal women']","['Korean red ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['Biological Aging and Antioxidant Capacity', 'mtDNA copy number, total antioxidant status, and improved symptoms of fatigue', 'mitochondria DNA (mtDNA) copy number as an indicator of biological aging and, total antioxidant status (TAS', 'fatigue severity scale', 'biological aging and antioxidant capacity', 'Clinical symptoms of fatigue']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085759', 'cui_str': 'Aging, Biological'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",63.0,0.771136,"The mtDNA copy number (KRG group: 1.58 ± 2.05, placebo group: 0.28 ± 2.36,  p  = 0.023) and TAS (KRG group: 0.11 ± 0.25 mmol/L, placebo group: -0.04 ± 0.16 mmol/L,  p  = 0.011) increased and the fatigue severity scale (KRG group: -7 ± 12, placebo group: -1 ± 11,  p  = 0.033) decreased significantly more in the KRG group than the placebo group.","[{'ForeName': 'Tae-Ha', 'Initials': 'TH', 'LastName': 'Chung', 'Affiliation': 'Department of Family Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju 26426, Korea.'}, {'ForeName': 'Ji-Hye', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Health Promotion, Severance Check-Up, Yonsei University Health System, Seoul 03722, Korea.'}, {'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Seol', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital Biomedical Research Center, Yonsei University College of Medicine, Seoul 06273, Korea.'}, {'ForeName': 'Yon-Ji', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Health Promotion, Severance Check-Up, Yonsei University Health System, Seoul 03722, Korea.'}, {'ForeName': 'Yong-Jae', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea.'}]",Nutrients,['10.3390/nu13093090']
1765,34578807,Continuous Protein Supplementation Reduces Acute Exercise-Induced Stress Markers in Athletes Performing Marathon.,"The aim of this study was to determine the changes in endurance performance and metabolic, hormonal, and inflammatory markers induced by endurance stress (marathon race) in a combined strategy of training and dietary protein supplementation. The study was designed as a randomised controlled trial consisting of regular endurance training without and with a daily intake of a soy protein-based supplement over a three-month period in 2 × 15 (10 males and 5 females per group) endurance-trained adults. Body composition (body mass, BMI, and fat mass) was determined, and physical fitness was measured by treadmill ergometry at baseline and after 3 months of intervention; changes in exercise-induced stress and inflammatory markers (CK, myoglobin, interleukin-6, cortisol, and leukocytes) were also determined before and after a marathon competition; eating behaviour was documented before and after intervention by a three-day diet diary. Although no significant influence on endurance performance was observed, the protein supplementation regime reduced the exercise-induced muscle stress response. Furthermore, a protein intake of ≥20% of total energy intake led to a lower-level stress reaction after the marathon race. In conclusion, supplementary protein intake may influence exercise-induced muscle stress reactions by changing cellular metabolism and inflammatory pathways.",2021,"Although no significant influence on endurance performance was observed, the protein supplementation regime reduced the exercise-induced muscle stress response.","['2 × 15 (10 males and 5 females per group) endurance-trained adults', 'Athletes Performing Marathon']","['training and dietary protein supplementation', 'Continuous Protein Supplementation', 'regular endurance training without and with a daily intake of a soy protein-based supplement']","['Acute Exercise-Induced Stress Markers', 'exercise-induced muscle stress response', 'endurance performance', 'endurance performance and metabolic, hormonal, and inflammatory markers', 'exercise-induced stress and inflammatory markers (CK, myoglobin, interleukin-6, cortisol, and leukocytes', 'Body composition (body mass, BMI, and fat mass']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0074926', 'cui_str': 'Soy Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",,0.0143944,"Although no significant influence on endurance performance was observed, the protein supplementation regime reduced the exercise-induced muscle stress response.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Röhling', 'Affiliation': 'West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': 'Public Health Nutrition Research Group, London Metropolitan University, London N7 8DB, UK.'}, {'ForeName': 'Aloys', 'Initials': 'A', 'LastName': 'Berg', 'Affiliation': 'Faculty of Medicine, University of Freiburg, 79117 Freiburg, Germany.'}]",Nutrients,['10.3390/nu13092929']
1766,34578798,Dietary Supplementation with Monosodium Glutamate Suppresses Chemotherapy-Induced Downregulation of the T1R3 Taste Receptor Subunit in Head and Neck Cancer Patients.,"(Background) We investigated the effect of dietary supplementation with monosodium glutamate (MSG) on chemotherapy-induced downregulation of the T1R3 taste receptor subunit expression in the tongue of patients with advanced head and neck cancer. (Methods) Patients undergoing two rounds of chemoradiotherapy were randomly allocated to a control or intervention group (dietary supplementation with MSG at 2.7 g/day during the second round of chemotherapy). The relative expression of T1R3, a subunit of both umami and sweet taste receptors, in the tongue was assessed by quantitative polymerase chain reaction analysis. Dysgeusia was assessed with a visual analog scale and daily energy intake was evaluated. (Results) T1R3 expression levels in the tongue, taste sensitivity, and daily energy intake were significantly reduced after the first round of chemotherapy compared with before treatment. Furthermore, these parameters significantly decreased after the second round of chemotherapy, but the extent of decrease was significantly attenuated in the MSG group compared with the control group. (Conclusions) MSG supplementation suppresses chemotherapy-induced dysgeusia, possibly due to the inhibition of the T1R3-containing taste receptor downregulation in the tongue, thereby increasing energy intake in patients with advanced head and neck cancer.",2021,"(Results) T1R3 expression levels in the tongue, taste sensitivity, and daily energy intake were significantly reduced after the first round of chemotherapy compared with before treatment.","['Methods) Patients undergoing two rounds of', 'Head and Neck Cancer Patients', 'patients with advanced head and neck cancer']","['control or intervention group (dietary supplementation with MSG', 'chemoradiotherapy', 'MSG', 'dietary supplementation with monosodium glutamate (MSG', 'Dietary Supplementation with Monosodium Glutamate']","['Dysgeusia', 'T1R3 expression levels', 'taste sensitivity, and daily energy intake', 'visual analog scale and daily energy intake']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0037511', 'cui_str': 'Monosodium glutamate'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0382574,"(Results) T1R3 expression levels in the tongue, taste sensitivity, and daily energy intake were significantly reduced after the first round of chemotherapy compared with before treatment.","[{'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Shono', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Beppu', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Matsushima', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Suzuno', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kanamura', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ohnishi', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kondo', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Azuma', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Sato', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Kawai', 'Affiliation': 'Frontier Research Laboratories, Institute for Innovation, Ajinomoto Co. Inc., Kawasaki 210-8681, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Frontier Research Laboratories, Institute for Innovation, Ajinomoto Co. Inc., Kawasaki 210-8681, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Kitamura', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakaue', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Takeda', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.'}]",Nutrients,['10.3390/nu13092921']
1767,34578782,"Growth, Dietary Intake, and Vitamin D Receptor (VDR) Promoter Genotype in Indonesian School-Age Children.","Nutrition has been known as a predominant factor associated with stunting. However, some studies have discovered a genetic contribution in calcium absorption that will affect growth, known as the VDR gene. The aim of this study was to assess the association between VDR gene polymorphism and dietary intake towards height-for-age z-score (HAZ) of elementary school children in Malang District, East Java. This study analyzed the baseline of a randomized trial in East Java, Indonesia. School children aged 8-10 years old ( n  = 142) were included in this study. Energy, protein, calcium, and vitamin D intakes were obtained using 4-day 24-h dietary recalls. Two SNPs located in the promoter region of VDR gene were selected (rs11568820 and rs4516035) and analyzed using Real-Time PCR. The result showed a significant correlation between energy and protein intake with HAZ of the children ( p  = 0.030 and  p  = 0.016, respectively). The association between VDR gene and HAZ was not found ( p  > 0.05). Adjusted by other factors, protein intake was significantly correlated with HAZ (β = 0.034, 95% CI 0.015-0.052,  p  < 0.001, adj. R 2  = 0.089). The children in our study had a favorable VDR gene genotype, however the effect of VDR gene promoter activity might not be revealed due to very low vitamin D and calcium intake to stimulate intestinal calcium absorption which in turn affects HAZ.",2021,"The result showed a significant correlation between energy and protein intake with HAZ of the children ( p  = 0.030 and  p  = 0.016, respectively).","['School children aged 8-10 years old ( n  = 142', 'Indonesian School-Age Children', 'East Java, Indonesia', 'elementary school children in Malang District, East Java']",[],"['energy and protein intake', 'protein intake', 'VDR gene polymorphism and dietary intake towards height-for-age z-score (HAZ', 'Growth, Dietary Intake, and Vitamin D Receptor (VDR', 'VDR gene and HAZ', 'Energy, protein, calcium, and vitamin D intakes']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205803', 'cui_str': 'Java'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}]",[],"[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C3657722', 'cui_str': 'VDR protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0108082', 'cui_str': 'Vitamin D3 Receptor'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0564439', 'cui_str': 'Vitamin D intake'}]",142.0,0.106983,"The result showed a significant correlation between energy and protein intake with HAZ of the children ( p  = 0.030 and  p  = 0.016, respectively).","[{'ForeName': 'Tiffany Cornelia', 'Initials': 'TC', 'LastName': 'Angelin', 'Affiliation': 'Southeast Asian Ministers of Education Organization Regional Center for Food and Nutrition (SEAMEO RECFON)-Pusat Kajian Gizi Regional, Universitas Indonesia, Jakarta 10430, Indonesia.'}, {'ForeName': 'Saptawati', 'Initials': 'S', 'LastName': 'Bardosono', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Universitas Indonesia-Dr. Cipto Mangunkusumo General Hospital, Jakarta 10430, Indonesia.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Shinta', 'Affiliation': 'Southeast Asian Ministers of Education Organization Regional Center for Food and Nutrition (SEAMEO RECFON)-Pusat Kajian Gizi Regional, Universitas Indonesia, Jakarta 10430, Indonesia.'}, {'ForeName': 'Umi', 'Initials': 'U', 'LastName': 'Fahmida', 'Affiliation': 'Southeast Asian Ministers of Education Organization Regional Center for Food and Nutrition (SEAMEO RECFON)-Pusat Kajian Gizi Regional, Universitas Indonesia, Jakarta 10430, Indonesia.'}]",Nutrients,['10.3390/nu13092904']
1768,34583667,Effectiveness of sexual health influencers identified by an ensemble machine learning model in promoting secondary distribution of HIV self-testing among men who have sex with men in China: study protocol for a quasi-experimental trial.,"BACKGROUND


HIV self-testing (HIVST), especially the secondary distribution of HIVST (SD-HIVST) initiated by sexual health influencers (SHIs), has been recognized as an effective strategy in promoting HIV testing, especially among men who have sex with men (MSM). This quasi-experimental study aimed to evaluate whether SHIs identified through the ensemble machine learning approach can distribute more HIVST than those who identified by the empiricalscale.
METHODS


We will recruit eligible adults (≥18 years old) who were assigned male gender at birth, and willing to participate in potential SD-HIVST online. Participants will be assigned randomly to two groups (scale group or machine learning group), followed by a separate process of SHI identification based on the group assignment. After identification, all index participants (defined as identified SHIs who are verbally consented to participate in SD-HIVST or who directly order HIVST kits) will follow the same procedure for SD-HIVST acquisition and distribution. Index participants can order HIVST online and distribute them to members within their social networks (defined as alters) in-person or virtually through a personalized peer referral link. Once a unique alter uploads a photographed test result to the platform, both the alter and the corresponding index participant will receive a fixed incentive of 3 USD. The index MSM can order up to five HIVST in the first three months and ten HIVST in the following three months. Each index participant will need to complete a baseline survey at the first-time ordering and one to two follow-upbased on the times of ordering,, three months after ordering. This trial will be comparing 1) the mean number of alters motivated by each index participant in each group and 2) the mean number of newly-tested alters motivated by each index participant in each group.
DISCUSSION


In promoting the efficacy of identifying SHIs for SD-HIVST, our study has the potential to enhance testing coverage, particularly among marginalized individuals and those who are reluctant to for HIV and other sexually transmitted infections.
TRIAL REGISTRATION


We registered the study on the Chinese Clinical Trial Registry website on 4th November 2021, with registration number ChiCTR2000039632 .",2021,The index MSM can order up to five HIVST in the first three months and ten HIVST in the following three months.,"['eligible adults (≥18\u2009years old) who were assigned male gender at birth, and willing to participate in potential SD-HIVST online', 'men who have sex with men in China', 'men who have sex with men (MSM']",['machine learning'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}]",[],,0.14257,The index MSM can order up to five HIVST in the first three months and ten HIVST in the following three months.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Qianyun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Fengshi', 'Initials': 'F', 'LastName': 'Jing', 'Affiliation': 'Institute for Healthcare Artificial Intelligence, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Zhuhai Xutong Voluntary Services Center, Zhuhai, China.'}, {'ForeName': 'Shanzi', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Wencan', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China. weiming_tang@med.unc.edu.'}]",BMC public health,['10.1186/s12889-021-11817-2']
1769,34582501,The effectiveness of simulation education program on shared decision-making attitudes among nurses in Taiwan.,"BACKGROUND


Shared decision-making (SDM) is significantly associated with promoting the quality of end-of-life (EOL). The attitude of nurses toward the end of life can affect EOL care, but there are few SDM-related clinical learning programs focused on EOL. In this study, therefore, we evaluated the effectiveness of an EOL-simulation education program on attitudes toward SDM among nurses, using an objective structured clinical examination (OSCE).
METHODS


We used a quasi-experimental study design to evaluate nurses working at a medical center in Taiwan. We recruited 100 nurses and assigned them to an experimental group (n = 50) and a control group (n = 50). The experimental group received the SDM attitude (SDMA) cultivation program, and the control group did not. After the intervention, all participants were examined in an OSCE to assess the efficacy of their learning. A p value of.05 was considered statistically significant.
RESULTS


The average score of the experimental group was higher than that of the control group in the dimensions ""empathic communication"" and ""mastery learning"", but these differences were not significant. SDMA score is significantly and positively correlated with SDMA global score, standardized patient survey (SPS) score, and SPS global score (r = .92, .56, and .50, respectively; p < .01).
CONCLUSIONS


Simulations concerning EOL care that incorporate SDM components would be effective for training clinical nurses. This study can serve as a reference for nursing-administration managers who may consider designing SDM-related education programs to improve the quality of clinical nursing care.",2021,"The average score of the experimental group was higher than that of the control group in the dimensions ""empathic communication"" and ""mastery learning"", but these differences were not significant.","['nurses working at a medical center in Taiwan', 'nurses in Taiwan', '100 nurses and assigned them to an experimental group (n = 50) and a control group (n = 50']","['simulation education program', 'EOL-simulation education program', 'SDM attitude (SDMA) cultivation program']","['SDMA global score, standardized patient survey (SPS) score, and SPS global score', 'average score', 'SDMA score']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",100.0,0.023687,"The average score of the experimental group was higher than that of the control group in the dimensions ""empathic communication"" and ""mastery learning"", but these differences were not significant.","[{'ForeName': 'Mei-Hsiang', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan, R.O.C.'}, {'ForeName': 'Shu-Chuan', 'Initials': 'SC', 'LastName': 'Lin', 'Affiliation': 'MacKay Memorial Hospital, Taipei, Taiwan, R.O.C.'}, {'ForeName': 'Yu-Hsia', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'MacKay Memorial Hospital, Taipei, Taiwan, R.O.C.'}, {'ForeName': 'Pao-Yu', 'Initials': 'PY', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, MacKay Junior College of Medicine, Nursing and Management, New Taipei City, Taiwan, R.O.C.'}, {'ForeName': 'Hon-Yen', 'Initials': 'HY', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan, R.O.C.'}, {'ForeName': 'Hsiu-Chin', 'Initials': 'HC', 'LastName': 'Hsu', 'Affiliation': 'Department of Internal Medicine, Graduate Institute of Gerontology and Health Care Management, Chang Gung University of Science and Technology, Chang Gung Memorial Hospital, Taoyan, Taiwan, R.O.C.'}]",PloS one,['10.1371/journal.pone.0257902']
1770,34586881,The Impact of Music Training and Working Memory on Speech Recognition in Older Age.,"Purpose Music training has been proposed as a possible tool for auditory training in older adults, as it may improve both auditory and cognitive skills. However, the evidence to support such benefits is mixed. The goal of this study was to determine the differential effects of lifelong musical training and working memory on speech recognition in noise, in older adults. Method A total of 31 musicians and nonmusicians aged 65-78 years took part in this cross-sectional study. Participants had a normal pure-tone average, with most having high-frequency hearing loss. Working memory (memory capacity) was assessed with the backward Digit Span test, and speech recognition in noise was assessed with three clinical tests (Quick Speech in Noise, Hearing in Noise Test, and Revised Speech Perception in Noise). Results Findings from this sample of older adults indicate that neither music training nor working memory was associated with differences on the speech recognition in noise measures used in this study. Similarly, duration of music training was not associated with speech-in-noise recognition. Conclusions Results from this study do not support the hypothesis that lifelong music training benefits speech recognition in noise. Similarly, an effect of working memory (memory capacity) was not apparent. While these findings may be related to the relatively small sample size, results across previous studies that investigated these effects have also been mixed. Prospective randomized music training studies may be able to better control for variability in outcomes associated with pre-existing and music training factors, as well as to examine the differential impact of music training and working memory for speech-in-noise recognition in older adults.",2021,Results Findings from this sample of older adults indicate that neither music training nor working memory was associated with differences on the speech recognition in noise measures used in this study.,"['31 musicians and nonmusicians aged 65-78 years took part in this cross-sectional study', 'Older Age', 'older adults', 'Participants had a normal pure-tone average, with most having high-frequency hearing loss']","['music training', 'lifelong musical training and working memory', 'Music training', 'Music Training and Working Memory']","['working memory (memory capacity', 'Working memory (memory capacity', 'backward Digit Span test, and speech recognition in noise', 'clinical tests (Quick Speech in Noise, Hearing in Noise Test, and Revised Speech Perception in Noise', 'duration of music training']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0018780', 'cui_str': 'Upper frequency deafness'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0117748,Results Findings from this sample of older adults indicate that neither music training nor working memory was associated with differences on the speech recognition in noise measures used in this study.,"[{'ForeName': 'Bruna S', 'Initials': 'BS', 'LastName': 'Mussoi', 'Affiliation': 'Speech Pathology and Audiology, Kent State University, OH.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2021_JSLHR-20-00426']
1771,34581196,Outcomes and Complications of Open vs Posterior Arthroscopic Subtalar Arthrodesis: A Prospective Randomized Controlled Multicenter Study.,"BACKGROUND


Open subtalar arthrodesis is the standard treatment for subtalar arthritis. Posterior arthroscopic subtalar arthrodesis (PASTA) has recently gained increasing popularity due to a shorter recovery time and better cosmesis. However, studies comparing outcomes and complications between these 2 techniques are limited.
METHODS


In total, 56 patients with subtalar joint arthritis were prospectively randomized to 2 parallel groups to receive either PASTA (n = 28 patients) or open subtalar arthrodesis (n = 28 patients). The minimum follow-up period was 12 months. Primary outcome was union rate confirmed on postoperative computed tomography (CT) scan. Secondary outcomes were union time; visual analog scale (VAS), Short Form-36 (SF-36), and Foot and Ankle Ability Measure (FAAM) scores; tourniquet time; and complications.
RESULTS


Union time (9.4 vs 12.8 weeks) and recovery time (time to return to activities of daily living [8.4 vs 10.8 weeks], work [10.6 vs 12.9 weeks], and sports [24.9 vs 32.7 weeks]) were significantly shorter with PASTA than with the open technique ( P  < .05 all). Both techniques led to significant improvements in all functional outcomes (FAAM, SF-36, and VAS scores;  P  < .01 all); however, there was no significant difference between the techniques in these outcomes ( P  > .05 all). Other outcomes, including tourniquet time (55.8 vs 67.2 min), union rate (96.3% vs 100%), and complication rate, were not significantly different between the techniques.
CONCLUSION


Both open and PASTA techniques led to significant improvements in pain and function in patients with isolated subtalar joint arthritis. Although short-term functional outcomes and complication rates were not significantly different between the techniques, the PASTA technique was better at shortening the union and recovery times.
LEVEL OF EVIDENCE


Level I, prospective multicenter randomized controlled trial.",2021,Both open and PASTA techniques led to significant improvements in pain and function in patients with isolated subtalar joint arthritis.,"['subtalar arthritis', 'patients with isolated subtalar joint arthritis', '56 patients with subtalar joint arthritis']","['Posterior arthroscopic subtalar arthrodesis (PASTA', 'open subtalar arthrodesis', 'Open vs Posterior Arthroscopic Subtalar Arthrodesis', 'PASTA']","['union time; visual analog scale (VAS), Short Form-36 (SF-36), and Foot and Ankle Ability Measure (FAAM) scores; tourniquet time; and complications', 'tourniquet time', 'Union time', 'recovery time (time to return to activities of daily living', 'complication rate', 'complication rates', 'functional outcomes (FAAM, SF-36, and VAS scores', 'union rate confirmed on postoperative computed tomography (CT) scan', 'union rate', 'pain and function']","[{'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038593', 'cui_str': 'Subtalar joint structure'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0188673', 'cui_str': 'Subtalar arthrodesis'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",56.0,0.103162,Both open and PASTA techniques led to significant improvements in pain and function in patients with isolated subtalar joint arthritis.,"[{'ForeName': 'Chamnanni', 'Initials': 'C', 'LastName': 'Rungprai', 'Affiliation': 'Department of Orthopaedics, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Aekachai', 'Initials': 'A', 'LastName': 'Jaroenarpornwatana', 'Affiliation': 'Department of Orthopaedics, Klang Hospital, Bangkok, Thailand.'}, {'ForeName': 'Nusorn', 'Initials': 'N', 'LastName': 'Chaiprom', 'Affiliation': 'Department of Orthopaedics, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Phinit', 'Initials': 'P', 'LastName': 'Phisitkul', 'Affiliation': 'Department of Orthopaedics, Tri-State Specialists, Sioux City, IA, USA.'}, {'ForeName': 'Yantarat', 'Initials': 'Y', 'LastName': 'Sripanich', 'Affiliation': 'Department of Orthopaedics, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}]",Foot & ankle international,['10.1177/10711007211047239']
1772,34581025,Effectiveness of various human papillomavirus vaccination strategies: A community randomized trial in Finland.,"INTRODUCTION


We conducted a community-randomized trial (NCTBLINDED) in Finland to assess gender-neutral and girls-only vaccination strategies with the AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18)vaccine.
METHODS


Girls and boys (12-15 years) were invited. We randomized 33 communities (1:1:1 ratio): Arm A: 90% of randomly selected girls and boys received AS04-HPV-16/18 vaccine and 10% received hepatitis B vaccine (HBV); Arm B: 90% of randomly selected girls received AS04-HPV-16/18 vaccine, 10% of girls received HBV, and all boys received HBV; Arm C: all participants received HBV. Effectiveness measurements against prevalence of HPV-16/18 cervical infection were estimated in girls at 18.5 years. The main measures were: (1) overall effectiveness comparing Arms A or B, regardless of vaccination status, vs Arm C; (2) total effectiveness comparing AS04-HPV-16/18 vaccinated girls in pooled Arms A/B vs Arm C; (3) indirect effectiveness (herd effect) comparing girls receiving HBV or unvaccinated in Arm A vs Arm C. Co-primary objectives were overall effectiveness following gender-neutral or girls-only vaccination.
RESULTS


Of 80,272 adolescents invited, 34,412 were enrolled. Overall effectiveness was 23.8% (95% confidence interval: -19.0, 51.1; P = 0.232) with gender-neutral vaccination. Following girls-only vaccination, overall effectiveness was 49.6% (20.1, 68.2; P = 0.004). Total effectiveness was over 90% regardless of vaccination strategy. No herd effect was found. Immunogenicity of the AS04-HPV-16/18 vaccine was high in both sexes.
CONCLUSIONS


This study illustrates the difficulty in conducting community randomized trials. It is not plausible that vaccinating boys would reduce overall effectiveness, and the apparent lack of herd effect was unexpected given findings from other studies. This analysis was likely confounded by several factors but confirms the vaccine's high total effectiveness as in clinical trials.",2021,"Overall effectiveness was 23.8% (95% confidence interval: -19.0, 51.1; P = 0.232) with gender-neutral vaccination.","['80,272 adolescents invited, 34,412 were enrolled', 'Girls and boys (12-15\xa0years) were invited', '33 communities (1:1:1 ratio', 'girls at 18.5\xa0years']","['AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18)vaccine', 'AS04-HPV-16/18 vaccine', 'AS04-HPV-16/18 vaccine and 10% received hepatitis B vaccine (HBV', 'AS04-HPV-16/18 vaccine, 10% of girls received HBV, and all boys received HBV; Arm C', 'HBV', 'various human papillomavirus vaccination strategies']","['Immunogenicity', 'Overall effectiveness', 'Effectiveness measurements against prevalence of HPV-16/18 cervical infection', 'overall effectiveness comparing Arms A or B, regardless of vaccination status, vs Arm C; (2) total effectiveness', 'Total effectiveness']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4517611', 'cui_str': '18.5'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1443394', 'cui_str': 'Vaccination status'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",33.0,0.274087,"Overall effectiveness was 23.8% (95% confidence interval: -19.0, 51.1; P = 0.232) with gender-neutral vaccination.","[{'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Department of Vaccines, National Institute for Health & Welfare, Helsinki, Finland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'VL-Medi Clinical Research Center, Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Harjula', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hokkanen', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Natunen', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Nieminen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Paavonen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Palmroth', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Petäjä', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Pukkala', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Simopekka', 'Initials': 'S', 'LastName': 'Vänskä', 'Affiliation': 'Finnish Institute for Health and Welfare, Helsinki and Oulu, Finland.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Cheuvart', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Maaria', 'Initials': 'M', 'LastName': 'Soila', 'Affiliation': 'GSK, Espoo, Finland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bi', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'GSK, Wavre, Belgium.'}]",Cancer medicine,['10.1002/cam4.4299']
1773,34579074,Associations between Postprandial Gut Hormones and Markers of Bone Remodeling.,"Gut-derived hormones have been suggested to play a role in bone homeostasis following food intake, although the associations are highly complex and not fully understood. In a randomized, two-day cross-over study on 14 healthy individuals, we performed postprandial time-course studies to examine the associations of the bone remodeling markers carboxyl-terminal collagen type I crosslinks (CTX) and procollagen type 1 N-terminal propeptide (P1NP) with the gut hormones glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide 1 (GLP-1), and peptide YY (PYY) using two different meal types-a standardized mixed meal (498 kcal) or a granola bar (260 kcal). Plasma concentrations of total GIP, total GLP-1, total PYY, CTX, and P1NP were measured up to 240 min after meal intake, and the incremental area under the curve (iAUC) for each marker was calculated. The iAUC of CTX and P1NP were used to assess associations with the iAUC of GIP, GLP-1, and PYY in linear mixed effect models adjusted for meal type. CTX was positively associated with GIP and GLP-1, and it was inversely associated with PYY (all  p  < 0.001). No associations of P1NP with GIP or GLP-1 and PYY were found. In conclusion, the postprandial responses of the gut hormones GIP, GLP-1, and PYY are associated with the bone resorption marker CTX, supporting a link between gut hormones and bone homeostasis following food intake.",2021,"Plasma concentrations of total GIP, total GLP-1, total PYY, CTX, and P1NP were measured up to 240 min after meal intake, and the incremental area under the curve (iAUC) for each marker was calculated.",['14 healthy individuals'],"['CTX', 'bone remodeling markers carboxyl-terminal collagen type I crosslinks (CTX) and procollagen type 1 N-terminal propeptide (P1NP) with the gut hormones glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide 1 (GLP-1), and peptide YY (PYY) using two different meal types-a standardized mixed meal']","['Postprandial Gut Hormones and Markers of Bone Remodeling', 'Plasma concentrations of total GIP, total GLP-1, total PYY, CTX, and P1NP']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}]",14.0,0.046653,"Plasma concentrations of total GIP, total GLP-1, total PYY, CTX, and P1NP were measured up to 240 min after meal intake, and the incremental area under the curve (iAUC) for each marker was calculated.","[{'ForeName': 'Nina Wittorff', 'Initials': 'NW', 'LastName': 'Jensen', 'Affiliation': 'Clinical Prevention Research, Steno Diabetes Center Copenhagen, 2820 Gentofte, Denmark.'}, {'ForeName': 'Kim Katrine Bjerring', 'Initials': 'KKB', 'LastName': 'Clemmensen', 'Affiliation': 'Clinical Prevention Research, Steno Diabetes Center Copenhagen, 2820 Gentofte, Denmark.'}, {'ForeName': 'Marie Møller', 'Initials': 'MM', 'LastName': 'Jensen', 'Affiliation': 'Clinical Prevention Research, Steno Diabetes Center Copenhagen, 2820 Gentofte, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Clinical Prevention Research, Steno Diabetes Center Copenhagen, 2820 Gentofte, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Færch', 'Affiliation': 'Clinical Prevention Research, Steno Diabetes Center Copenhagen, 2820 Gentofte, Denmark.'}, {'ForeName': 'Lars Jorge', 'Initials': 'LJ', 'LastName': 'Diaz', 'Affiliation': 'Clinical Epidemiology Research, Steno Diabetes Center Copenhagen, 2820 Gentofte, Denmark.'}, {'ForeName': 'Jonas Salling', 'Initials': 'JS', 'LastName': 'Quist', 'Affiliation': 'Clinical Prevention Research, Steno Diabetes Center Copenhagen, 2820 Gentofte, Denmark.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Størling', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, 1165 Copenhagen, Denmark.'}]",Nutrients,['10.3390/nu13093197']
1774,34579068,"The Effect of Probiotics (MCP ®  BCMC ®  Strains) on Hepatic Steatosis, Small Intestinal Mucosal Immune Function, and Intestinal Barrier in Patients with Non-Alcoholic Fatty Liver Disease.","Treatment for non-alcoholic fatty liver disease (NAFLD) currently consists of lifestyle modifications such as a low-fat diet, weight loss, and exercise. The gut microbiota forms part of the gut-liver axis and serves as a potential target for NAFLD treatment. We investigated the effect of probiotics on hepatic steatosis, fibrosis, and biochemical blood tests in patients with NAFLD. At the small intestinal mucosal level, we examined the effect of probiotics on the expression of CD4+ and CD8+ T lymphocytes, as well as the tight junction protein zona occluden-1 (ZO-1). This was a randomized, double-blind, placebo-controlled trial involving ultrasound-diagnosed NAFLD patients ( n  = 39) who were supplemented with either a probiotics sachet (MCP ®  BCMC ®  strains) or a placebo for a total of 6 months. Multi-strain probiotics (MCP ®  BCMC ®  strains) containing six different  Lactobacillus  and  Bifidobacterium  species at a concentration of 30 billion CFU were used. There were no significant changes at the end of the study in terms of hepatic steatosis (probiotics: -21.70 ± 42.6 dB/m,  p  = 0.052 vs. placebo: -10.72 ± 46.6 dB/m,  p  = 0.29) and fibrosis levels (probiotics: -0.25 ± 1.77 kPa,  p  = 0.55 vs. placebo: -0.62 ± 2.37 kPa,  p  = 0.23) as measured by transient elastography. Likewise, no significant changes were found for both groups for the following parameters: LiverFAST analysis (steatosis, fibrosis and inflammation scores), alanine aminotransferase, total cholesterol, triglycerides, and fasting glucose. In the immunohistochemistry (IHC) analysis, no significant expression changes were seen for CD4+ T lymphocytes in either group (probiotics: -0.33 ± 1.67,  p  = 0.35 vs. placebo: 0.35 ± 3.25,  p  = 0.63). However, significant reductions in the expression of CD8+ T lymphocytes (-7.0 ± 13.73,  p  = 0.04) and ZO-1 (Z-score = -2.86,  p  = 0.04) were found in the placebo group, but no significant changes in the probiotics group. In this pilot study, the use of probiotics did not result in any significant clinical improvement in NAFLD patients. However, at the microenvironment level (i.e., the small intestinal mucosa), probiotics seemed to be able to stabilize the mucosal immune function and to protect NAFLD patients against increased intestinal permeability. Therefore, probiotics might have a complementary role in treating NAFLD. Further studies with larger sample sizes, a longer duration, and different probiotic strains are needed to evaluate the real benefit of probiotics in NAFLD.",2021,"However, significant reductions in the expression of CD8+ T lymphocytes (-7.0 ± 13.73,  p  = 0.04) and ZO-1 (Z-score = -2.86,  p  = 0.04) were found in the placebo group, but no significant changes in the probiotics group.","['non-alcoholic fatty liver disease (NAFLD', 'patients with NAFLD', 'patients ( n  = 39', 'Patients with Non-Alcoholic Fatty Liver Disease', 'NAFLD patients']","['probiotics', 'Probiotics (MCP ®  BCMC ®  Strains', 'ultrasound-diagnosed NAFLD', 'placebo', 'probiotics sachet (MCP ®  BCMC ®  strains']","['hepatic steatosis, fibrosis, and biochemical blood tests', 'LiverFAST analysis (steatosis, fibrosis and inflammation scores), alanine aminotransferase, total cholesterol, triglycerides, and fasting glucose', 'intestinal permeability', 'hepatic steatosis', 'ZO-1', 'CD4+ T lymphocytes', 'expression of CD8+ T lymphocytes', 'expression of CD4+ and CD8+ T lymphocytes', 'fibrosis levels']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}]","[{'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.169485,"However, significant reductions in the expression of CD8+ T lymphocytes (-7.0 ± 13.73,  p  = 0.04) and ZO-1 (Z-score = -2.86,  p  = 0.04) were found in the placebo group, but no significant changes in the probiotics group.","[{'ForeName': 'Mohamad Hizami', 'Initials': 'MH', 'LastName': 'Mohamad Nor', 'Affiliation': 'Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia.'}, {'ForeName': 'Nurainina', 'Initials': 'N', 'LastName': 'Ayob', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia.'}, {'ForeName': 'Norfilza M', 'Initials': 'NM', 'LastName': 'Mokhtar', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia.'}, {'ForeName': 'Raja Affendi', 'Initials': 'RA', 'LastName': 'Raja Ali', 'Affiliation': 'Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia.'}, {'ForeName': 'Geok Chin', 'Initials': 'GC', 'LastName': 'Tan', 'Affiliation': 'GUT Research Group, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia.'}, {'ForeName': 'Zhiqin', 'Initials': 'Z', 'LastName': 'Wong', 'Affiliation': 'Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia.'}, {'ForeName': 'Nor Hamizah', 'Initials': 'NH', 'LastName': 'Shafiee', 'Affiliation': 'Dietetics Programme, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia.'}, {'ForeName': 'Yin Ping', 'Initials': 'YP', 'LastName': 'Wong', 'Affiliation': 'Department of Pathology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia.'}, {'ForeName': 'Muaatamarulain', 'Initials': 'M', 'LastName': 'Mustangin', 'Affiliation': 'Department of Pathology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia.'}, {'ForeName': 'Khairul Najmi Muhammad', 'Initials': 'KNM', 'LastName': 'Nawawi', 'Affiliation': 'Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia.'}]",Nutrients,['10.3390/nu13093192']
1775,34595723,Effect of Different Modes of Administration of Dexmedetomidine Combined with Nerve Block on Postoperative Analgesia in Total Knee Arthroplasty.,"INTRODUCTION


Dexmedetomidine (DEX) as a nerve block adjuvant can significantly prolong analgesia. However, whether perineural or systemic administration of DEX is more beneficial in patients undergoing total knee arthroplasty (TKA) has not been thoroughly investigated. To this end, we evaluated the effects of perineural and systemic DEX administration on postoperative analgesia in patients undergoing TKA surgery.
METHODS


We randomly assigned patients undergoing TKA under general anesthesia combined with femoral nerve block and sciatic nerve block to one of three groups: (1) ropivacaine plus perineural dexmedetomidine (DP): 0.25% ropivacaine 40 mL plus 0.5 μg/kg dexmedetomidine; (2) ropivacaine plus systemic dexmedetomidine (DS): 0.25% ropivacaine 40 mL plus systemic 0.5 μg/kg dexmedetomidine; (3) control group (C): 0.25% ropivacaine 40 mL.
RESULTS


The average length of time until patients first experienced postoperative pain was significantly longer in the DP group (26.0 h [22.0-30.0 h]) than in the DS group (22.4 h [18-26.8 h]) and the control group (22.9 h [19.5-26.3 h], P = 0.001). For this result there was no significant difference between the DS and the control group. Compared with the DS and control groups, patients in the DP group had lower resting visual analogue scale (VAS) scores at 24, 48, and 72 h after surgery (P < 0.05). VAS activity scores at 12, 24, and 48 h after surgery in the DP group were lower than those in the DS and control groups, with a statistically significant difference (P < 0.05). Compared with the DS and control groups, the amount of postoperative opioids in the DP group was also significantly reduced, and the number of people needing postoperative rescue analgesia was significantly lower, with a statistical difference (P < 0.05). Meanwhile, the sleep satisfaction of patients in the DP group on the first night after surgery and the satisfaction with pain control at 72 h after surgery were both higher than those in the DS group and control group (P < 0.05).
CONCLUSIONS


Perineural administration of DEX can significantly prolong the interval until patients report pain for the first time after TKA, relieve postoperative pain, reduce postoperative opioid dosage, and improve postoperative sleep quality and satisfaction with pain control.
TRIAL REGISTRATION


The trial was registered at the Chinese Clinical Trial Registry, identifier ChiCTR1900025808.",2021,"Compared with the DS and control groups, patients in the DP group had lower resting visual analogue scale (VAS) scores at 24, 48, and 72 h after surgery (P < 0.05).","['patients undergoing total knee arthroplasty (TKA', 'Total Knee Arthroplasty', 'patients undergoing TKA surgery']","['Dexmedetomidine Combined with Nerve Block', 'ropivacaine plus systemic dexmedetomidine (DS): 0.25% ropivacaine 40\xa0mL plus systemic 0.5\xa0μg/kg dexmedetomidine', 'perineural and systemic DEX', 'ropivacaine plus perineural dexmedetomidine (DP): 0.25% ropivacaine 40\xa0mL plus 0.5\xa0μg/kg dexmedetomidine', 'DEX', 'ropivacaine', 'TKA under general anesthesia combined with femoral nerve block and sciatic nerve block', 'Dexmedetomidine (DEX']","['interval until patients report pain', 'sleep satisfaction', 'amount of postoperative opioids', 'resting visual analogue scale (VAS) scores', 'satisfaction with pain control', 'number of people needing postoperative rescue analgesia', 'average length of time until patients first experienced postoperative pain', 'VAS activity scores', 'postoperative sleep quality and satisfaction with pain control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.241997,"Compared with the DS and control groups, patients in the DP group had lower resting visual analogue scale (VAS) scores at 24, 48, and 72 h after surgery (P < 0.05).","[{'ForeName': 'Xiao-Bin', 'Initials': 'XB', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Ya-Ru', 'Initials': 'YR', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Rui-Hong', 'Initials': 'RH', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Guang-Hong', 'Initials': 'GH', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China. xuguanghong2004@163.com.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Mei', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Jia-Nan', 'Initials': 'JN', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui, China.'}]",Pain and therapy,['10.1007/s40122-021-00320-6']
1776,34597375,Role of radiotherapy to bulky sites of advanced Hodgkin lymphoma treated with ABVD: final results of FIL HD0801 trial.,"The role of consolidation radiotherapy (RT) for bulky lesions is controversial in patients with advanced-stage Hodgkin lymphoma who achieve complete metabolic response (CMR) after doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD)-based chemotherapy. We present the final results of the Fondazione Italiana Linfomi HD0801 trial, which investigated the potential benefit of RT in that setting. In this phase 3 randomized study, patients with a bulky lesion at baseline (a mass with largest diameter ≥5 cm) who have CMR after 2 and 6 ABVD cycles were randomly assigned 1:1 to RT vs observation (OBS) with a primary endpoint of event-free survival (EFS) at 2 years. The sample size was calculated estimating an EFS improvement for RT of 20% (from 60% to 80%). The secondary end point was progression-free survival (PFS). One hundred sixteen patients met the inclusion criteria and were randomly assigned to RT or OBS. Intention-to-treat (ITT) analysis showed a 2-year EFS of 87.8% vs 85.8% for RT vs OBS (hazard ratio [HR], 1.5; 95% confidence interval [CI], 0.6-3.5; P = .34). At 2 years, ITT-PFS was 91.3% vs 85.8% (HR, 1.2; 95% CI, 0.5-3; P = .7). Patients in CMR randomly assigned to OBS had a good outcome, and the primary end point of a 20% benefit in EFS for RT was not met. However, the sample size was underpowered to detect a benefit of 10% or less, keeping open the question of a potential, more limited role of RT in this setting. This trial was registered at www.clinicaltrials.gov as #NCT00784537.",2021,"At 2 years, ITT PFS was 91.3% vs. 85.8% (HR:1.2, CI:0.5-3, p=0.7), while PP PFS was 93.8% vs. 85.8% (HR:0.7, CI:0.2-2.1, p=0.52) for RT vs observation, respectively.","['patients with a bulky lesion at baseline (mass with the largest diameter ≥5 cm) achieving CMR after 2 and 6 ABVD cycles', 'One-hundred and sixteen (116) patients met the inclusion criteria and were randomized', ""advanced-stage Hodgkin's lymphoma (HL) patients achieving complete metabolic response (CMR) after ABVD-based chemotherapy"", 'advanced Hodgkin lymphoma treated with ABVD']","['radiotherapy', 'consolidation radiotherapy (RT']","['ITT PFS', '2-year EFS', 'PP PFS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0050380', 'cui_str': 'ABVD-I protocol'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}]","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",116.0,0.172568,"At 2 years, ITT PFS was 91.3% vs. 85.8% (HR:1.2, CI:0.5-3, p=0.7), while PP PFS was 93.8% vs. 85.8% (HR:0.7, CI:0.2-2.1, p=0.52) for RT vs observation, respectively.","[{'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Ricardi', 'Affiliation': 'Department of Oncology, University of Torino, Torino, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Levis', 'Affiliation': 'Department of Oncology, University of Torino, Torino, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Evangelista', 'Affiliation': 'Clinical Epidemiology, Città della Salute e della Scienza and Centro di Prevenzione Oncologica (CPO) Piemonte, Torino, Italy.'}, {'ForeName': 'Daniela Maria', 'Initials': 'DM', 'LastName': 'Gioia', 'Affiliation': 'Fondazione Italiana Linfomi Onlus, Alessandria, Italy.'}, {'ForeName': 'Gian Mauro', 'Initials': 'GM', 'LastName': 'Sacchetti', 'Affiliation': 'Nuclear Medicine, ""Maggiore della Carità"" Hospital, Novara, Italy.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gotti', 'Affiliation': 'Department of Hematology, Fondazione, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Re', 'Affiliation': 'Department of Hematology, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Buglione', 'Affiliation': 'Department of Radiation Oncology, University and Azienda Socio Sanitaria Territoriale (ASST) Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pavone', 'Affiliation': 'Department of Hematology and Bone Marrow Transplant, Hospital Card. G. Panico, Tricase, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nardella', 'Affiliation': 'Department of Radiation Oncology, Città di Lecce Hospital, Lecce, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Nassi', 'Affiliation': 'Hematology, Department of Translational Medicine, Azienda Ospedaliero Universitaria (AOU) ""Maggiore della Carità"" and University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Zanni', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Franzone', 'Affiliation': 'Radiation Oncology Department, Servizio Sanitario (SS) Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.'}, {'ForeName': 'Giovanni Piero', 'Initials': 'GP', 'LastName': 'Frezza', 'Affiliation': 'Radiation Oncology Unit, Bellaria Hospital, Bologna, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Pulsoni', 'Affiliation': 'Haematology Department of Translational and Precision Medicine, Sapienza University, Rome, Italy.'}, {'ForeName': 'Lavinia', 'Initials': 'L', 'LastName': 'Grapulin', 'Affiliation': 'Department of Radiotherapy, Policlinico Umberto I Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Rigacci', 'Affiliation': 'Department of Hematology.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Simontacchi', 'Affiliation': 'Radiation Oncology Unit, AOU Careggi, Florence, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tani', 'Affiliation': 'Hematology Unit, S Maria delle Croci Hospital, Ravenna, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zaja', 'Affiliation': 'Department of Haematology, Azienda Ospedaliero-Universitaria Santa Maria della Misericordia, Udine, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Abruzzese', 'Affiliation': ""Hematology Unit, Sant'Eugenio Hospital, Azienda Sanitaria Locale (ASL) Roma 2, Tor Vergata University, Rome, Italy.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Botto', 'Affiliation': 'Hematology Unit, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Vittorio Ruggero', 'Initials': 'VR', 'LastName': 'Zilioli', 'Affiliation': 'Division of Hematology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Rota-Scalabrini', 'Affiliation': ""Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute Fondazione del Piemonte per l'Oncologia (FPO), IRCCS, Candiolo, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Freilone', 'Affiliation': 'Hematology Unit, Stabilimento Ospedaliero Ivrea, Torino, Italy.'}, {'ForeName': 'Giovannino', 'Initials': 'G', 'LastName': 'Ciccone', 'Affiliation': 'Clinical Epidemiology, Città della Salute e della Scienza and Centro di Prevenzione Oncologica (CPO) Piemonte, Torino, Italy.'}, {'ForeName': 'Andrea Riccardo', 'Initials': 'AR', 'LastName': 'Filippi', 'Affiliation': 'Radiation Oncology, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Pavia, Italy.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'IRCCS AOU di Bologna; and.'}]",Blood advances,['10.1182/bloodadvances.2021005150']
1777,34600346,Comparison of day 2 and overnight day 3 frozen embryo transfers: A prospective randomized controlled trial.,"In certain patients cleavage stage embryos may be preferred. The relationship between an additional day in culture and pregnancy outcomes is not well established. We aimed to compare outcomes of day 2 versus overnight day 3 frozen embryo transfer (FET). In this randomized controlled trial, patients with day 2 cryopreserved embryos were allocated to two groups. In group A embryos were transferred on day 2, the same day of thawing. In group B embryos were transferred one day after thawing, on day 3 after overnight incubation. Out of 410 patients eligible, 92 were recruited. Finally, 72 patients participated, 39 in group A and 33 in group B. No significant difference in implantation (11 % in group A and 14 % in group B, p = 0.81), clinical pregnancy (18 % in group A and 21 % in group B, p = 0.73) or live birth rates (13 % in group A and 18 % in group B, p = 0.53) was found. To conclude, no significant difference in reproductive outcomes was found when comparing patients with day 2 or overnight day 3 FET. Considering published data on blastocyst transfer, cleavage stage ET may still be a relevant option and the decision between day 2 or overnight day 3 ET depends on patients' and physicians' preference and recommendation.",2021,"Finally, 72 patients participated, 39 in group A and 33 in group B. No significant difference in implantation (11 % in group A and 14 % in group B, p = 0.81), clinical pregnancy (18 % in group A and 21 % in group B, p = 0.73) or live birth rates (13 % in group A and 18 % in group B, p = 0.53) was found.","['patients with day 2 cryopreserved embryos', '410 patients eligible, 92 were recruited']",['overnight day 3 frozen embryo transfer (FET'],"['reproductive outcomes', 'live birth rates', 'clinical pregnancy', 'implantation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}]","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",410.0,0.0962093,"Finally, 72 patients participated, 39 in group A and 33 in group B. No significant difference in implantation (11 % in group A and 14 % in group B, p = 0.81), clinical pregnancy (18 % in group A and 21 % in group B, p = 0.73) or live birth rates (13 % in group A and 18 % in group B, p = 0.53) was found.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Nahshon', 'Affiliation': 'Division of Reproductive Endocrinology and IVF, Department of Obstetrics and Gynecology, Lady Davis Carmel Medical Center, Haifa, Israel; Ruth and Bruch Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel. Electronic address: chenn@clalit.org.il.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Dirnfeld', 'Affiliation': 'Division of Reproductive Endocrinology and IVF, Department of Obstetrics and Gynecology, Lady Davis Carmel Medical Center, Haifa, Israel; Ruth and Bruch Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Koifman', 'Affiliation': 'Division of Reproductive Endocrinology and IVF, Department of Obstetrics and Gynecology, Lady Davis Carmel Medical Center, Haifa, Israel; Ruth and Bruch Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Idit', 'Initials': 'I', 'LastName': 'Blais', 'Affiliation': 'Division of Reproductive Endocrinology and IVF, Department of Obstetrics and Gynecology, Lady Davis Carmel Medical Center, Haifa, Israel; Ruth and Bruch Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shirly', 'Initials': 'S', 'LastName': 'Lahav-Baratz', 'Affiliation': 'Division of Reproductive Endocrinology and IVF, Department of Obstetrics and Gynecology, Lady Davis Carmel Medical Center, Haifa, Israel; Ruth and Bruch Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}]",Reproductive biology,['10.1016/j.repbio.2021.100565']
1778,34599979,"Efficacy and safety of benralizumab in chronic rhinosinusitis with nasal polyps: A randomized, placebo-controlled trial.","BACKGROUND


Eosinophilic inflammation has been implicated in the pathogenesis, severity, and treatment responsiveness of chronic rhinosinusitis with nasal polyps (CRSwNP).
OBJECTIVE


We sought to assess the efficacy and safety of benralizumab-mediated eosinophil depletion for treating CRSwNP.
METHODS


The phase 3 OSTRO study enrolled patients with severe CRSwNP who were symptomatic despite treatment with intranasal corticosteroids and who had a history of systemic corticosteroid (SCS) use and/or surgery for nasal polyps (NP). Patients were randomized 1:1 to treatment with benralizumab 30 mg or placebo every 4 weeks for the first 3 doses and every 8 weeks thereafter. Coprimary end points were change from baseline to week 40 in NP score (NPS) and patient-reported mean nasal blockage score reported once every 2 weeks.
RESULTS


The study population comprised 413 randomized patients (207 in the benralizumab group and 206 in the placebo group). Benralizumab significantly improved NPS and nasal blockage score compared to placebo at week 40 (P ≤ .005). Improvements in Sinonasal Outcome Test 22 score at week 40, time to first NP surgery and/or SCS use for NP, and time to first NP surgery were not statistically significant between treatment groups. Nominal significance was obtained for improvement in difficulty in sense of smell score at week 40 (P = .003). Subgroup analyses suggested influences of comorbid asthma, number of NP surgeries, sex, body mass index, and baseline blood eosinophil count on treatment effects. Benralizumab was safe and well tolerated.
CONCLUSION


Benralizumab, when added to standard-of-care therapy, reduced NPS, decreased nasal blockage, and reduced difficulty with sense of smell compared to placebo in patients with CRSwNP.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03401229.",2021,Nominal significance was achieved for improvement in difficulty in sense of smell score at week 40 (P = .003).,"['enrolled patients with severe CRSwNP who were symptomatic despite treatment with intranasal corticosteroids and who had a history of systemic corticosteroid (SCS) use and/or surgery for nasal polyps (NP', 'Chronic Rhinosinusitis with Nasal Polyps', 'patients with CRSwNP', '413 randomized patients (benralizumab, 207; placebo, 206', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['benralizumab', 'Placebo', 'benralizumab 30 mg or placebo', 'Benralizumab', 'placebo']","['nasal polyp score (NPS) and patient-reported biweekly mean nasal blockage score (NBS', 'NPS and NBS', 'safe and well tolerated', 'Sinonasal Outcome Test-22 score at week 40, time to first NP surgery and/or SCS use for NP, and time to first NP surgery', 'comorbid asthma, number of NP surgeries, sex, body mass index, and baseline blood eosinophil count', 'nasal blockage', 'difficulty with sense of smell', 'difficulty in sense of smell score', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2982078', 'cui_str': 'benralizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2982078', 'cui_str': 'benralizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",413.0,0.234664,Nominal significance was achieved for improvement in difficulty in sense of smell score at week 40 (P = .003).,"[{'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bachert', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium. Electronic address: Claus.Bachert@UGent.be.'}, {'ForeName': 'Joseph K', 'Initials': 'JK', 'LastName': 'Han', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, Va.'}, {'ForeName': 'Martin Y', 'Initials': 'MY', 'LastName': 'Desrosiers', 'Affiliation': ""Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM), Montréal, Québec, Canada.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gevaert', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Heffler', 'Affiliation': 'Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy; Humanitas University, Pieve Emanuele, Italy.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hopkins', 'Affiliation': ""Guy's and St Thomas' NHS Trust, London, United Kingdom.""}, {'ForeName': 'Jody R', 'Initials': 'JR', 'LastName': 'Tversky', 'Affiliation': 'Johns Hopkins University, Baltimore, Md.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barker', 'Affiliation': 'AstraZeneca, Gaithersburg, Md.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'AstraZeneca, Gaithersburg, Md.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Emson', 'Affiliation': 'Translational Science and Experimental Medicine, Research and Early Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Md.'}, {'ForeName': 'Ubaldo J', 'Initials': 'UJ', 'LastName': 'Martin', 'Affiliation': 'AstraZeneca, Gaithersburg, Md.'}, {'ForeName': 'Vivian H', 'Initials': 'VH', 'LastName': 'Shih', 'Affiliation': 'AstraZeneca, Gaithersburg, Md.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Necander', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Kreindler', 'Affiliation': 'AstraZeneca, Gaithersburg, Md.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jison', 'Affiliation': 'AstraZeneca, Gaithersburg, Md.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Werkström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.08.030']
1779,34601232,Randomized controlled trial of moderate cardiovascular exercise for patients with drug-resistant epilepsy.,"OBJECTIVE


The primary research question of this study was whether a moderate cardiovascular exercise program can reduce seizure frequency in patients with focal drug-resistant epilepsy (DRE). The hypothesis is that cardiovascular fitness will reduce seizure frequency in persons with epilepsy (PWE).
METHODS


Twenty-eight patients were randomized into two groups; exercise or relaxation. The exercise group were given an ergometric bicycle sent to their home to be used for 150 min/week, 30 min/day for 5 days a week for the study period of 6 months. Participants in the relaxation group were given audio muscular relaxation exercises to be performed for 20 min at least five times per week for the study period of 6 months. Seizure counts and exercise/relaxation sessions were registered daily in a written diary. Both groups received monthly motivational telephone calls. Seizures, anxiety, and depression symptom ratings (Hospital Anxiety and Depression Scale (HADS)), health status ratings (RAND-36), aerobic capacity (estimated VO 2 max), self-efficacy for exercise (SEE), level of physical activity, and adverse events were measured at the baseline and after the 6 months of intervention. CONSORT guidelines were followed.
RESULTS


Twenty-two patients completed the intervention. There were no significant changes in seizure frequency in either of the groups. Six months of moderate exercise did increase the level of physical activity and maximal oxygen uptake.
SIGNIFICANCE


Moderate exercise did not affect seizure frequency in this study. The patients in the exercise group did increase their estimated VO 2max , which is an important indicator for health, without deterioration of seizure frequency. This was accomplished with only minimal support from a physiotherapist every month. To exercise at home at a moderate intensity level with regular support may therefore be an option for patients with epilepsy. The patients in the exercise group increased their level of physical activity significantly, which indicates that they were compliant to the treatment.",2021,"The patients in the exercise group increased their level of physical activity significantly, which indicates that they were compliant to the treatment.","['patients with drug-resistant epilepsy', 'patients with epilepsy', 'Twenty-eight patients', 'patients with focal drug-resistant epilepsy (DRE', 'persons with epilepsy (PWE']","['moderate cardiovascular exercise program', 'exercise or relaxation', 'moderate cardiovascular exercise', 'ergometric bicycle sent', 'audio muscular relaxation exercises', 'monthly motivational telephone calls']","['level of physical activity', 'Seizure counts and exercise/relaxation sessions', 'level of physical activity and maximal oxygen uptake', 'estimated VO 2max', 'Seizures, anxiety, and depression symptom ratings (Hospital Anxiety and Depression Scale (HADS)), health status ratings (RAND-36), aerobic capacity (estimated VO 2 max), self-efficacy for exercise (SEE), level of physical activity, and adverse events', 'seizure frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0203993', 'cui_str': 'Relaxation exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}]",28.0,0.0156478,"The patients in the exercise group increased their level of physical activity significantly, which indicates that they were compliant to the treatment.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Åkerlund', 'Affiliation': 'Region Västra Götaland, Sahlgrenska University Hospital/Östra, Department of Occupational and Physiotherapy, Gothenburg, Sweden; Department of Health and Rehabilitation/Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Varkey', 'Affiliation': 'Region Västra Götaland, Sahlgrenska University Hospital/Östra, Department of Occupational and Physiotherapy, Gothenburg, Sweden; Department of Health and Rehabilitation/Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Klecki', 'Affiliation': 'Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Neuroscience and Physiology, Department of Clinical Neuroscience, Sahlgrenska Academy, Gothenburg University, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Zelano', 'Affiliation': 'Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Neuroscience and Physiology, Department of Clinical Neuroscience, Sahlgrenska Academy, Gothenburg University, Sweden; Wallenberg Center of Molecular and Translational Medicine, Gothenburg University, Sweden.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Ben-Menachem', 'Affiliation': 'Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Neuroscience and Physiology, Department of Clinical Neuroscience, Sahlgrenska Academy, Gothenburg University, Sweden. Electronic address: elinor.ben-menachem@neuro.gu.se.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.108335']
1780,34600544,"In vivo efficacy and safety of artemether-lumefantrine and amodiaquine-artesunate for uncomplicated Plasmodium falciparum malaria in Mozambique, 2018.","BACKGROUND


Artemisinin-based combination therapy (ACT) has been the recommended first-line treatment for uncomplicated malaria in Mozambique since 2006, with artemether-lumefantrine (AL) and amodiaquine-artesunate (AS-AQ) as the first choice. To assess efficacy of currently used ACT, an in vivo therapeutic efficacy study was conducted.
METHODS


The study was conducted in four sentinel sites: Montepuez, Moatize, Mopeia and Massinga. Patients between 6 and 59 months old with uncomplicated Plasmodium falciparum malaria (2000-200,000 parasites/µl) were enrolled between February and September of 2018, assigned to either an AL or AS-AQ treatment arm, and monitored for 28 days. A Bayesian algorithm was applied to differentiate recrudescence from new infection using genotyping data of seven neutral microsatellites. Uncorrected and PCR-corrected efficacy results at day 28 were calculated.
RESULTS


Totals of 368 and 273 patients were enrolled in the AL and AS-AQ arms, respectively. Of these, 9.5% (35/368) and 5.1% (14/273) were lost to follow-up in the AL and AS-AQ arms, respectively. There were 48 and 3 recurrent malaria infections (late clinical and late parasitological failures) in the AL and AS-AQ arms, respectively. The day 28 uncorrected efficacy was 85.6% (95% confidence interval (CI) 81.3-89.2%) for AL and 98.8% (95% CI 96.7-99.8%) for AS-AQ, whereas day 28 PCR-corrected efficacy was 97.9% (95% CI 95.6-99.2%) for AL and 99.6% (95% CI 97.9-100%) for AS-AQ. Molecular testing confirmed that 87.4% (42/48) and 33.3% (1/3) of participants with a recurrent malaria infection in the AL and AS-AQ arms were new infections; an expected finding in a high malaria transmission area. Adverse events were documented in less than 2% of participants for both drugs.
CONCLUSION


Both AL and AS-AQ have therapeutic efficacies well above the 90% WHO recommended threshold and remain well-tolerated in Mozambique. Routine monitoring of therapeutic efficacy should continue to ensure the treatments remain efficacious. Trial registration Clinicaltrials.gov: NCT04370977.",2021,"The day 28 uncorrected efficacy was 85.6% (95% confidence interval (CI) 81.3-89.2%) for AL and 98.8% (95% CI 96.7-99.8%) for AS-AQ, whereas day 28 PCR-corrected efficacy was 97.9% (95% CI 95.6-99.2%) for AL and 99.6% (95% CI 97.9-100%) for AS-AQ.","['four sentinel sites: Montepuez, Moatize, Mopeia and Massinga', 'Totals of 368 and 273 patients were enrolled in the AL and AS-AQ arms, respectively', 'uncomplicated Plasmodium falciparum malaria in Mozambique, 2018', 'Patients between 6 and 59\xa0months old with uncomplicated Plasmodium falciparum malaria (2000-200,000\xa0parasites/µl) were enrolled between February and September of 2018, assigned to either an']","['artemether-lumefantrine and amodiaquine-artesunate', 'Artemisinin-based combination therapy (ACT', 'amodiaquine-artesunate (AS-AQ', 'AL or AS-AQ']","['recurrent malaria infections (late clinical and late parasitological failures', 'therapeutic efficacies', 'Adverse events']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0024535', 'cui_str': 'Falciparum malaria'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C1869889', 'cui_str': 'artesunate and amodiaquine'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.256968,"The day 28 uncorrected efficacy was 85.6% (95% confidence interval (CI) 81.3-89.2%) for AL and 98.8% (95% CI 96.7-99.8%) for AS-AQ, whereas day 28 PCR-corrected efficacy was 97.9% (95% CI 95.6-99.2%) for AL and 99.6% (95% CI 97.9-100%) for AS-AQ.","[{'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Nhama', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Lídia', 'Initials': 'L', 'LastName': 'Nhamússua', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Quique', 'Initials': 'Q', 'LastName': 'Bassat', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Crizolgo', 'Initials': 'C', 'LastName': 'Salvador', 'Affiliation': 'Instituto Nacional de Saúde (INS), Ministério da Saúde, Maputo, Mozambique.'}, {'ForeName': 'Sónia', 'Initials': 'S', 'LastName': 'Enosse', 'Affiliation': 'Instituto Nacional de Saúde (INS), Ministério da Saúde, Maputo, Mozambique.'}, {'ForeName': 'Baltazar', 'Initials': 'B', 'LastName': 'Candrinho', 'Affiliation': 'Programa Nacional de Controlo da Malária, Ministério da Saúde, Maputo, Mozambique.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Carvalho', 'Affiliation': 'World Health Organization, WHO Country Office Maputo, Maputo, Mozambique.'}, {'ForeName': 'Arsénio', 'Initials': 'A', 'LastName': 'Nhacolo', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Arlindo', 'Initials': 'A', 'LastName': 'Chidimatembue', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Abuchahama', 'Initials': 'A', 'LastName': 'Saifodine', 'Affiliation': ""United States President's Malaria Initiative, United States Agency for International Development, Maputo, Mozambique.""}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Zulliger', 'Affiliation': ""United States President's Malaria Initiative, Centers for Disease Control and Prevention, Maputo, Mozambique.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Lucchi', 'Affiliation': 'Malaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Samaly S', 'Initials': 'SS', 'LastName': 'Svigel', 'Affiliation': 'Malaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Leah F', 'Initials': 'LF', 'LastName': 'Moriarty', 'Affiliation': 'Malaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Halsey', 'Affiliation': 'Malaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Mayor', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Aide', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique. pedro.aide@manhica.net.'}]",Malaria journal,['10.1186/s12936-021-03922-9']
1781,34606077,Single and Composite Endpoints of Within-Patient Improvement in Symptoms: Pooled Tanezumab Data in Patients with Osteoarthritis.,"INTRODUCTION


Combining measures of key core domains (especially pain and function) into a composite endpoint that requires each patient to meet a threshold of improvement for each domain provides information on multiple aspects of osteoarthritis within individual patients. This pooled analysis of two phase 3 studies (NCT02697773, NCT02709486) explored single and composite endpoints for assessing within-patient improvement in knee or hip osteoarthritis symptoms following subcutaneous administration of tanezumab or placebo.
METHODS


Endpoints at week 16 included proportions of responders (≥ 30% improvement) in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, WOMAC Physical Function, WOMAC Pain/Function composite, and weekly average pain; and patient acceptable symptom state (PASS) composite responders, minimal clinically important improvement (MCII) composite responders, Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responders, and sustained weekly average pain responders.
RESULTS


Pooled population comprised 1545 patients. Of patients who had a ≥ 30% improvement in WOMAC Pain and/or WOMAC Physical Function, 88.5% were WOMAC Pain/Function composite responders, 7.0% were WOMAC Pain (but not Function) responders, and 4.4% were WOMAC Function (but not Pain) responders. Of weekly average pain responders, 43.1% were PASS composite responders. Odds ratios (tanezumab 2.5 mg and 5 mg groups, respectively, vs placebo) were 1.75 and 1.86 (WOMAC Pain/Function composite responders), 1.41 and 1.65 (weekly average pain responders), 1.60 and 1.73 (PASS composite responders), 1.52 and 1.68 (MCII composite responders), 1.75 and 1.88 (OMERACT-OARSI responders), and 1.85 and 1.48 (sustained weekly average pain responders). Subgroup analyses suggested a greater magnitude of effect for patients with a knee index joint compared with hip on some endpoints.
CONCLUSION


Responders on single pain endpoints were in many cases also responders on function or composite endpoints. Separation of tanezumab from placebo was similar and consistent across single and composite endpoints.",2021,"Odds ratios (tanezumab 2.5 mg and 5 mg groups, respectively, vs placebo) were 1.75 and 1.86 (WOMAC Pain/Function composite responders), 1.41 and 1.65 (weekly average pain responders), 1.60 and 1.73 (PASS composite responders), 1.52 and 1.68 (MCII composite responders), 1.75 and 1.88 (OMERACT-OARSI responders), and 1.85 and 1.48 (sustained weekly average pain responders).","['Patients with Osteoarthritis', 'Endpoints at week\xa016 included proportions of responders (≥\u200930% improvement) in Western Ontario and McMaster Universities Osteoarthritis Index', 'osteoarthritis within individual patients']","['tanezumab from placebo', 'tanezumab or placebo']","['knee or hip osteoarthritis symptoms', 'WOMAC Function', 'WOMAC) Pain, WOMAC Physical Function, WOMAC Pain/Function composite, and weekly average pain; and patient acceptable symptom state (PASS) composite responders, minimal clinically important improvement (MCII) composite responders, Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responders, and sustained weekly average pain responders', 'WOMAC Pain/Function composite responders', 'Odds ratios', 'single pain endpoints', 'WOMAC Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C2346819', 'cui_str': 'tanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]",,0.165843,"Odds ratios (tanezumab 2.5 mg and 5 mg groups, respectively, vs placebo) were 1.75 and 1.86 (WOMAC Pain/Function composite responders), 1.41 and 1.65 (weekly average pain responders), 1.60 and 1.73 (PASS composite responders), 1.52 and 1.68 (MCII composite responders), 1.75 and 1.88 (OMERACT-OARSI responders), and 1.85 and 1.48 (sustained weekly average pain responders).","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Schnitzer', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Internal Medicine/Rheumatology, and Anesthesiology, Northwestern University Feinberg School of Medicine, 710 N Lake Shore Drive, Room 1020, Chicago, IL, USA. tjs@northwestern.edu.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Berenbaum', 'Affiliation': 'Department of Rheumatology, Sorbonne Université, INSERM CRSA, AP-HP Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Dworkin', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Gatti', 'Affiliation': 'Department of Rheumatology, University of Verona, Verona, Italy.'}, {'ForeName': 'Ruoyong', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Viktrup', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Davignon', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Verburg', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}]",Rheumatology and therapy,['10.1007/s40744-021-00372-2']
1782,34602470,Diet Effects on Cerebrospinal Fluid Amino Acids Levels in Adults with Normal Cognition and Mild Cognitive Impairment.,"BACKGROUND


Exploration of cerebrospinal fluid (CSF) amino acids and the impact of dietary intake on central levels may provide a comprehensive understanding of the metabolic component of Alzheimer's disease.
OBJECTIVE


The objective of this exploratory study was to investigate the effects of two diets with varied nutrient compositions on change in CSF amino acids levels in adults with mild cognitive impairment (MCI) and normal cognition (NC). Secondary objectives were to assess the correlations between the change in CSF amino acids and change in Alzheimer's disease biomarkers.
METHODS


In a randomized, parallel, controlled feeding trial, adults (NC, n = 20; MCI, n = 29) consumed a high saturated fat (SFA)/glycemic index (GI) diet [HIGH] or a low SFA/GI diet [LOW] for 4 weeks. Lumbar punctures were performed at baseline and 4 weeks.
RESULTS


CSF valine increased and arginine decreased after the HIGH compared to the LOW diet in MCI (ps = 0.03 and 0.04). This pattern was more prominent in MCI versus NC (diet by diagnosis interaction ps = 0.05 and 0.09), as was an increase in isoleucine after the HIGH diet (p = 0.05). Changes in CSF amino acids were correlated with changes in Alzheimer's disease CSF biomarkers Aβ42, total tau, and p-Tau 181, with distinct patterns in the relationships by diet intervention and cognitive status.
CONCLUSION


Dietary intake affects CSF amino acid levels and the response to diet is differentially affected by cognitive status.",2021,"Changes in CSF amino acids were correlated with changes in Alzheimer's disease CSF biomarkers Aβ42, total tau, and p-Tau 181, with distinct patterns in the relationships by diet intervention and cognitive status.
","['adults (NC, n\u200a=\u200a20; MCI, n\u200a=\u200a29', 'Adults with Normal Cognition and Mild Cognitive Impairment', 'adults with mild cognitive impairment (MCI) and normal cognition (NC']","['consumed a high saturated fat (SFA)/glycemic index (GI) diet [HIGH] or a low SFA/GI diet [LOW', 'diets with varied nutrient compositions', 'MCI']","['CSF amino acids levels', 'CSF amino acids', 'Cerebrospinal Fluid Amino Acids Levels', ""CSF amino acids and change in Alzheimer's disease biomarkers"", 'CSF amino acid levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2712133', 'cui_str': 'Normal cognition'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.180811,"Changes in CSF amino acids were correlated with changes in Alzheimer's disease CSF biomarkers Aβ42, total tau, and p-Tau 181, with distinct patterns in the relationships by diet intervention and cognitive status.
","[{'ForeName': 'Kate J', 'Initials': 'KJ', 'LastName': 'Russin', 'Affiliation': 'Department of Internal Medicine- Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'K Sreekumaran', 'Initials': 'KS', 'LastName': 'Nair', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Montine', 'Affiliation': 'Department of Pathology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Baker', 'Affiliation': 'Department of Internal Medicine- Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': 'Department of Internal Medicine- Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-210471']
1783,34614432,Efficacy comparison of optimal treatments for hepatocellular carcinoma patients with portal vein tumor thrombus.,"INTRODUCTION AND OBJECTIVES


Optimal treatment of hepatocellular carcinoma (HCC) involving portal vein tumor thrombus (PVTT) remains controversial.
MATERIALS AND METHODS


A total of 627 HCC patients with PVTT after initial treatment with one of the following at Affiliated Tumor Hospital of Guangxi Medical University: liver resection (LR, n = 225), transarterial chemoembolization (TACE, n = 298) or sorafenib (n = 104) were recruited and randomly divided into the training cohort (n = 314) and internal validation cohort (n = 313). Survival analysis were repeated after stratifying patients by Cheng PVTT type.
RESULTS


Resection led to significantly higher OS than the other two treatments among patients with type I or II PVTT. TACE worked significantly better than the other two treatments for patients with type III. All three treatments were associated with similar OS among patients with type IV. These findings were supported by the internal validation cohort.
CONCLUSIONS


Our results suggest that the optimal treatment for HCC involving PVTT depends on the type of PVTT. LR may be more appropriate for type I or II PVTT; TACE, for type III Sorafenib may be more appropriate than invasive treatments for patients with type IV PVTT.",2021,TACE worked significantly better than the other two treatments for patients with type III.,"['patients with type III', '627 HCC patients with PVTT after initial treatment with one of the following at Affiliated Tumor Hospital of Guangxi Medical University: liver resection (LR, n\u202f=\u202f225', 'hepatocellular carcinoma patients with portal vein tumor thrombus', 'n\u202f=\u202f104', 'patients with type IV PVTT']","['transarterial chemoembolization (TACE, n\u202f=\u202f298) or sorafenib', 'TACE']",['Survival analysis'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0529196', 'cui_str': 'Tumor Necrosis Factor-alpha Converting Enzyme'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}]",627.0,0.0210009,TACE worked significantly better than the other two treatments for patients with type III.,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China; Kaiyuan Langdong Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Jun-Li', 'Initials': 'JL', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Le-Qun', 'Initials': 'LQ', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China. Electronic address: zhuxun99118@163.comz.'}]",Annals of hepatology,['10.1016/j.aohep.2021.100552']
1784,34613973,Effect of photobiomodulation combined with physical therapy on functional performance in children with myelomeningocele: A protocol randomized clinical blind study.,"INTRODUCTION


Myelomeningocele is a severe type of spina bifida, resulting from improper closure of the neural tube. This condition drastically affects the structures of the spinal cord resulting in deficiencies. The combination of these deficiencies results in an overall decrease in mobility and functional participation amongst this population. Physiotherapy plays an essential role in rehabilitating people with MMC. The current literature shows that resources such as photobiomodulation (PBM) may support the rehabilitation of neurological conditions. The aim of the proposed study is to evaluate the effects of photobiomodulation (PBM) combined with physical therapy on functional performance in children with low lumbosacral myelomeningocele.
MATERIALS AND METHODS


This is a protocol randomized clinical blind study, that will include 30 individuals of both sexes, aged between 5 to 8 years, diagnosed with low and sacral lumbar myelomeningocele and capable of performing the sit-to-stand task. The participants will be randomly assigned into two treatment groups: PBM + physiotherapeutic exercises and sham PBM + physiotherapeutic exercises. Irradiation will be carried out with light emitting diode (LED) at a wavelength of 850 nm, energy of 25 J per point, 50 seconds per point and a power of 200 mW. The same device will be used in the placebo group but will not emit light. Muscle activity will be assessed using a portable electromyograph (BTS Engineering) and the sit-to-stand task will be performed as a measure of functioning. Electrodes will be positioned on the lateral gastrocnemius, tibialis anterior and rectus femoris muscles. The Pediatric Evaluation of Disability Inventory will be used to assess functional independence. Quality of life will be assessed using the Child Health Questionnaire-Parent Form 50. Changes in participation will be assessed using the Participation and Environment Measure for Children and Youth. The data will be analyzed with the aid of GraphPad PRISM.
DISCUSSION


The results of this study can contribute to a better understanding of the effectiveness of PBM on functioning and quality of life in children with myelomeningocele.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04425330.",2021,Muscle activity will be assessed using a portable electromyograph (BTS Engineering) and the sit-to-stand task will be performed as a measure of functioning.,"['children with low lumbosacral myelomeningocele', 'rehabilitating people with MMC', 'children with myelomeningocele', '30 individuals of both sexes, aged between 5 to 8 years, diagnosed with low and sacral lumbar myelomeningocele and capable of performing the sit-to-stand task']","['light emitting diode (LED', 'photobiomodulation combined with physical therapy', 'PBM + physiotherapeutic exercises and sham PBM + physiotherapeutic exercises', 'photobiomodulation (PBM) combined with physical therapy', 'PBM']","['Quality of life', 'Muscle activity', 'functioning and quality of life', 'functional performance', 'mobility and functional participation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C0025312', 'cui_str': 'Meningomyelocele'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C3536738', 'cui_str': 'Lumbar meningomyelocele'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.0477969,Muscle activity will be assessed using a portable electromyograph (BTS Engineering) and the sit-to-stand task will be performed as a measure of functioning.,"[{'ForeName': 'Tamiris', 'Initials': 'T', 'LastName': 'Silva', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Juliana Roque de', 'Initials': 'JR', 'LastName': 'Queiroz', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Karina Helga Leal', 'Initials': 'KHL', 'LastName': 'Turcio', 'Affiliation': 'Universidade Estadual de São Paulo (UNESP), Aracatuba, SP, Brazil.'}, {'ForeName': 'Daysi da Cruz', 'Initials': 'DDC', 'LastName': 'Tobelem', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Tamires Ribeiro', 'Initials': 'TR', 'LastName': 'Araújo', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Kevelin Siqueira Lira', 'Initials': 'KSL', 'LastName': 'Coutinho', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Chavantes', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Alessandro Melo', 'Initials': 'AM', 'LastName': 'Deana', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniela de Fátima Teixeira da', 'Initials': 'DFTD', 'LastName': 'Silva', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Paula Midori', 'Initials': 'PM', 'LastName': 'Castelo', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Diadema, SP, Brazil.'}, {'ForeName': 'Kristianne Porta Santos', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Raquel Agnelli', 'Initials': 'RA', 'LastName': 'Mesquita-Ferrari', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kalil Bussadori', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0253963']
1785,34583238,Using an educational mobile application to teach students to take vital signs.,"BACKGROUND


The utilization of smartphone applications in educational settings, specifically in the field of nursing, has grown increasingly popular. To date, there have been few, if any, smartphone applications dedicated specifically to the teaching of vital signs. The Clinic Vitals app was designed to be an acceptable substitute for in-person vital signs instruction.
OBJECTIVES


The objective of this study was to show the utility of the Clinic Vitals app as a pedagogical tool in comparison to in-person nursing educational instruction.
DESIGN


A crossover design was employed within collegiate nursing educational sessions to determine if Clinic Vitals was an equivalent alternative to traditional vital sign teaching methods.
PARTICIPANTS


Participants were first-year nursing students from six different lab sessions within the same undergraduate university.
METHODS


Students with little to no vital sign experience were given instruction via the Clinic Vitals mobile application or traditional learning. After the learning session, students were given skills assessments. After one week, students were given the opposite method of instruction followed by skills assessments.
RESULTS


Results showed that no significant difference was found between the two groups based on skills assessments. Mobile application and in-person instruction teaching methods produced a similar level of competency in students learning to take vital signs.
CONCLUSIONS


The utility of being able to access the application's videos and instructional articles at any time and anywhere that there is an internet connection would make the app particularly useful. The present study provides evidence that the Clinic Vitals mobile application can be a reliable substitute for in-person vital signs instruction. Recent educational advances have demonstrated that online videos, simulations, and mobile applications can be effective resources for nursing educators. There is potential for further study of the uses of educational mobile applications, including Clinic Vitals, for nursing education.",2021,The present study provides evidence that the Clinic Vitals mobile application can be a reliable substitute for in-person vital signs instruction.,"['students learning to take vital signs', 'Students with little to no vital sign experience were given', 'Participants were first-year nursing students from six different lab sessions within the same undergraduate university']",['instruction via the Clinic Vitals mobile application or traditional learning'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.040355,The present study provides evidence that the Clinic Vitals mobile application can be a reliable substitute for in-person vital signs instruction.,"[{'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Hester', 'Affiliation': 'University of Oklahoma College of Medicine, United States of America. Electronic address: landonhester77@gmail.com.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Reed', 'Affiliation': 'University of Oklahoma College of Medicine, United States of America.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Bohannan', 'Affiliation': 'University of Oklahoma College of Medicine, United States of America.'}, {'ForeName': 'McKenna', 'Initials': 'M', 'LastName': 'Box', 'Affiliation': 'University of Oklahoma College of Medicine, United States of America.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Wells', 'Affiliation': 'University of Oklahoma College of Medicine, United States of America.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': ""O'Neal"", 'Affiliation': 'Oklahoma Christian University, School of Nursing, United States of America.'}]",Nurse education today,['10.1016/j.nedt.2021.105154']
1786,34587217,Evidence-based vs. social media based high-intensity interval training protocols: Physiological and perceptual responses.,"OBJECTIVE


High intensity interval training (HIIT) is a time-efficient exercise modality to improve cardiorespiratory fitness, and has recently been popularised by social media influencers. However, little is known regarding acute physiological and perceptual responses to these online protocols compared to HIIT protocols used within research. The aim was to investigate acute physiological, perceptual and motivational responses to two HIIT protocols popular on social media, and compare these to two evidence-based protocols.
METHODS


Twenty-seven recreationally active (>1 exercise session /week) participants (Age: 22±3y, BMI: 24.3±2.4) completed a randomised cross-over study, whereby each participant completed four HIIT protocols, two already established in research (Ergo-60:60 (cycling 10x60s at 100%Wmaxwith 60s rest), BW-60:60 (body-weight exercises 10x60swith 60s rest)) and two promoted on social media (SM-20:10 (body-weight exercises 20x20swith 10s rest) and SM-40:20 (body-weight exercises 15x40s with 20s rest)). Blood lactate, heart rate (HR), feeling scale (FS), felt arousal scale (FSA), enjoyment and perceived competence were measured in response to each protocol.
RESULTS


Significant differences were observed between BW-60:60 and SM-20:10 for the proportion of intervals meeting the ACSM high-intensity exercise criterion (>80% of HRmax) (BW-60:60 93±10%, SM-20:10 74±20%, P = 0.039) and change in lactate (BW-60:60 +7.8±3.7mmol/L, SM-20:10 +5.5±2.6mmol/L, P = 0.001). The percentage of time spent above the criterion HR was also significantly lower in SM-20:10 compared to all other protocols (Ergo-60:60 13.9±4.9min, BW-60:60 13.5±3.5min, SM-40:20 12.1±2.4min, SM-20:10 7.7±3.1, P<0.05). No differences were observed in lowest reported FS between protocols (P = 0.268), but FS decreased linearly throughout Ergo-60:60 and BW-60:60 (first vs. last interval P<0.05), but not in SM-20:10 or SM-40:20 (P>0.05). Enjoyment was higher upon completion of BW-60:60 compared to Ergo-60:60 and SM-40:20 (P<0.05).
CONCLUSIONS


This study shows that HIIT protocols available on social media offer an interesting real-world alternative for promoting exercise participation. Future studies should continue to investigate these highly popular and practical HIIT protocols.",2021,"The percentage of time spent above the criterion HR was also significantly lower in SM-20:10 compared to all other protocols (Ergo-60:60 13.9±4.9min, BW-60:60 13.5±3.5min,","['Twenty-seven recreationally active (>1 exercise session /week) participants (Age: 22±3y, BMI: 24.3±2.4']","['High intensity interval training (HIIT', 'HIIT protocols, two already established in research (Ergo-60:60 (cycling 10x60s at 100%Wmaxwith 60s rest), BW-60:60 (body-weight exercises 10x60swith 60s rest)) and two promoted on social media (SM-20:10 (body-weight exercises 20x20swith 10s rest) and SM-40:20 (body-weight exercises 15x40s with 20s rest']","['Blood lactate, heart rate (HR), feeling scale (FS), felt arousal scale (FSA), enjoyment and perceived competence', 'percentage of time spent above the criterion HR', 'ACSM high-intensity exercise criterion', 'Enjoyment', 'FS', 'change in lactate']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0550253,"The percentage of time spent above the criterion HR was also significantly lower in SM-20:10 compared to all other protocols (Ergo-60:60 13.9±4.9min, BW-60:60 13.5±3.5min,","[{'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Hesketh', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Church', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Kinnafick', 'Affiliation': 'School of Sport, Exercise and Health Sciences, National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Sam O', 'Initials': 'SO', 'LastName': 'Shepherd', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Anton J M', 'Initials': 'AJM', 'LastName': 'Wagenmakers', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cocks', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Juliette A', 'Initials': 'JA', 'LastName': 'Strauss', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0257685']
1787,34591079,Evaluation of Levels of Triamcinolone Acetonide in Human Perilymph and Plasma After Intratympanic Application in Patients Receiving Cochlear Implants: A Randomized Clinical Trial.,"Importance


The use of intratympanically applied steroids is of increasing interest. Consequently, research has focused on finding an ideal drug that diffuses through the round window membrane and can be retained in the perilymph.
Objective


To compare levels of triamcinolone acetonide (TAC) in perilymph and plasma after intratympanic injection.
Design, Setting, and Participants


This randomized clinical trial included 40 patients receiving cochlear implants at a single tertiary care center in Vienna, Austria. Patients were randomized to 1 of 4 treatment groups receiving 1 of 2 intratympanic doses of TAC (10 mg/mL or 40 mg/mL) at 1 of 2 approximate time points (24 hours or 1 hour) before sampling the perilymph. Inclusion was carried out between November 2017 and January 2020, and data were analyzed in December 2020.
Interventions


All patients underwent intratympanic injection of TAC. During cochlear implantation, perilymph and plasma were sampled for further analysis.
Main Outcomes and Measures


Levels of TAC measured in perilymph and plasma.
Results


Among the 37 patients (median [range] age, 57 [26-88] years; 18 [49%] men) included in the analysis, TAC was present at a median (range) level of 796.0 (46.4-7706.7) ng/mL. In the majority of patients (n = 29; 78%), no drug was detectable in the plasma after intratympanic injection. Levels above the limit of detection were less than 2.5 ng/mL. The 1-factorial analysis of variance model showed lower TAC levels in the group that received TAC, 10 mg/mL, 24 hours before surgery (median, 271 ng/mL) compared with the group that received TAC, 10 mg/mL, 1 hour before surgery (median, 2877 ng/mL), as well as in comparison with the groups receiving TAC, 40 mg/mL, 24 hours before surgery (median, 2150 ng/mL) and 1 hour before surgery (median, 939 ng/mL). The 2-factorial analysis of variance model showed lower TAC levels in the group receiving TAC, 10 mg/mL, 24 hours before surgery than the group receiving TAC, 10 mg/mL, 1 hour before surgery, and higher TAC levels in the group receiving TAC, 40 mg/mL, 24 hours before surgery compared with the group receiving TAC, 10 mg/mL, 24 hours before surgery. Patients with thickening of the middle ear had statistically significantly higher plasma levels (median, 1.4 ng/mL vs 0 ng/mL) and lower perilymph levels (median, 213.1 ng/mL vs 904 ng/mL) than individuals with unremarkable middle ear mucosa.
Conclusions and Relevance


In this randomized clinical trial, TAC was shown to be a promising drug for intratympanic therapies, with similar levels in perilymph 1 hour and 24 hours after injection (distinctly in the groups receiving the 40 mg/mL dose). There was also minimal dissemination to the plasma, especially in patients with unremarkable middle ear mucosa.
Trial Registration


ClinicalTrials.gov Identifier: NCT03248856.",2021,"The 1-factorial analysis of variance model showed lower TAC levels in the group that received TAC, 10 mg/mL, 24 hours before surgery (median, 271 ng/mL) compared with the group that received TAC, 10 mg/mL, 1 hour before surgery (median, 2877 ng/mL), as well as in comparison with the groups receiving TAC, 40 mg/mL, 24 hours before surgery (median, 2150 ng/mL) and 1 hour before surgery (median, 939 ng/mL).","['patients with unremarkable middle ear mucosa', 'Patients Receiving Cochlear Implants', '40 patients receiving cochlear implants at a single tertiary care center in Vienna, Austria', 'Human Perilymph and Plasma', '37 patients (median [range] age, 57 [26-88] years; 18 [49%] men) included in the analysis, TAC was present at a median (range) level of 796.0 (46.4-7706.7) ng/mL', 'Inclusion was carried out between November 2017 and January 2020, and data were analyzed in December 2020']","['TAC', 'intratympanic injection of TAC', 'triamcinolone acetonide (TAC', 'Triamcinolone Acetonide']","['TAC levels', 'Measures\n\n\nLevels of TAC measured in perilymph and plasma', 'plasma levels', 'lower perilymph levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0031059', 'cui_str': 'Perilymph'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C1555371', 'cui_str': 'Intratympanic Injection'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031059', 'cui_str': 'Perilymph'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",40.0,0.261568,"The 1-factorial analysis of variance model showed lower TAC levels in the group that received TAC, 10 mg/mL, 24 hours before surgery (median, 271 ng/mL) compared with the group that received TAC, 10 mg/mL, 1 hour before surgery (median, 2877 ng/mL), as well as in comparison with the groups receiving TAC, 40 mg/mL, 24 hours before surgery (median, 2150 ng/mL) and 1 hour before surgery (median, 939 ng/mL).","[{'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Dahm', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Julia Clara', 'Initials': 'JC', 'LastName': 'Gausterer', 'Affiliation': 'Department of Pharmaceutical Technology and Biopharmaceutics, University of Vienna, Austria.'}, {'ForeName': 'Alice Barbara', 'Initials': 'AB', 'LastName': 'Auinger', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Honeder', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Gabor', 'Affiliation': 'Department of Pharmaceutical Technology and Biopharmaceutics, University of Vienna, Austria.'}, {'ForeName': 'Gottfried', 'Initials': 'G', 'LastName': 'Reznicek', 'Affiliation': 'Department of Pharmacognosy, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kaider', 'Affiliation': 'Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Riss', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Arnoldner', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Medical University of Vienna, Vienna, Austria.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2021.2492']
1788,34592180,"Addition of ramucirumab or merestinib to standard first-line chemotherapy for locally advanced or metastatic biliary tract cancer: a randomised, double-blind, multicentre, phase 2 study.","BACKGROUND


Biliary tract cancers are aggressive, rare, gastrointestinal malignancies with a poor prognosis; approximately half of patients with these cancers survive for less than 1 year after diagnosis with advanced disease. We aimed to evaluate the efficacy and safety of ramucirumab or merestinib in addition to first-line cisplatin-gemcitabine in patients with locally advanced or metastatic biliary tract cancer.
METHODS


We did a randomised, double-blind, phase 2 study at 81 hospitals across 18 countries. We enrolled patients with histologically or cytologically confirmed, non-resectable, recurrent, or metastatic biliary tract adenocarcinoma, who were treatment-naive, aged 18 years or older, with an Eastern Cooperative Oncology Group performance status of 0 or 1, estimated life expectancy of 3 months or more, and measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1. Eligible participants were randomly assigned (2:1:2:1) to receive either intravenous ramucirumab 8 mg/kg or placebo (on days 1 and 8 in 21-day cycles) or oral merestinib 80 mg or placebo (once daily) until disease progression, unacceptable toxicity, death, or patient or investigator request for discontinuation. All participants received intravenous cisplatin 25 mg/m 2  and gemcitabine 1000 mg/m 2  (on days 1 and 8 in 21-day cycles), for a maximum of eight cycles. Randomisation was done by an interactive web response system using a permuted block method (blocks of six) and was stratified by primary tumour site, geographical region, and presence of metastatic disease. Participants, investigators, and the study funder were masked to treatment assignment within the intravenous and oral groups. The primary endpoint was investigator-assessed progression-free survival (in the intention-to-treat population). The safety analysis was done in all patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT02711553, and long-term follow-up is ongoing.
FINDINGS


Between May 25, 2016, and Aug 8, 2017, 450 patients were assessed for eligibility and 309 (69%) were enrolled and randomly assigned to ramucirumab (n=106), merestinib (n=102), or pooled placebo (n=101); 306 received at least one dose of study treatment. The median follow-up time for progression-free survival at data cutoff (Feb 16, 2018) was 10·9 months (IQR 8·1-14·1). Median progression-free survival was 6·5 months (80% CI 5·7-7·1) in the ramucirumab group, 7·0 months (6·2-7·1) in the merestinib group, and 6·6 months (5·6-6·8) in the pooled placebo group (ramucirumab vs placebo hazard ratio 1·12 [80% CI 0·90-1·40], two-sided stratified p=0·48; merestinib vs placebo 0·92 [0·73-1·15], two-sided stratified p=0·64). The most common grade 3 or worse adverse events were neutropenia (51 [49%] of 104 patients in the ramucirumab group; 48 [47%] of 102 in the merestinib group; and 33 [33%] of 100 in the pooled placebo group), thrombocytopenia (36 [35%]; 19 [19%]; and 17 [17%]), and anaemia (28 [27%]; 16 [16%]; and 19 [19%]). Serious adverse events occurred in 53 (51%) patients in the ramucirumab group, 56 (55%) in the merestinib group, and 48 (48%) in the pooled placebo group. Treatment-related deaths (deemed related by the investigator) occurred in one (1%) of 104 patients in the ramucirumab group (cardiac arrest) and two (2%) of 102 patients in the merestinib group (pulmonary embolism [n=1] and sepsis [n=1]).
INTERPRETATION


Adding ramucirumab or merestinib to first-line cisplatin-gemcitabine was well tolerated, with no new safety signals, but neither improved progression-free survival in patients with molecularly unselected, locally advanced or metastatic biliary tract cancer. The role of these targeted inhibitors remains investigational, highlighting the need for further understanding of biliary tract malignancies and the contribution of molecular selection.
FUNDING


Eli Lilly and Company.",2021,"Median progression-free survival was 6·5 months (80% CI 5·7-7·1) in the ramucirumab group, 7·0 months (6·2-7·1) in the merestinib group, and 6·6 months (5·6-6·8) in the pooled placebo group (ramucirumab vs placebo hazard ratio 1·12","['patients with locally advanced or metastatic biliary tract cancer', 'Eligible participants', 'Between May 25, 2016, and Aug 8, 2017, 450 patients were assessed for eligibility and 309 (69', '81 hospitals across 18 countries', 'patients with molecularly unselected, locally advanced or metastatic biliary tract cancer', 'patients with these cancers survive for less than 1 year after diagnosis with advanced disease', 'locally advanced or metastatic biliary tract cancer', 'enrolled patients with histologically or cytologically confirmed, non-resectable, recurrent, or metastatic biliary tract adenocarcinoma, who were treatment-naive, aged 18 years or older, with an Eastern Cooperative Oncology Group performance status of 0 or 1, estimated life expectancy of 3 months or more, and measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1']","['oral merestinib 80 mg or placebo', 'cisplatin-gemcitabine', 'placebo 0·92', 'ramucirumab or merestinib to standard first-line chemotherapy', 'intravenous ramucirumab 8 mg/kg or placebo', 'ramucirumab', 'intravenous cisplatin 25 mg/m 2  and gemcitabine', 'pooled placebo']","['neutropenia', 'progression-free survival', 'Median progression-free survival', 'median follow-up time for progression-free survival', 'Serious adverse events', 'thrombocytopenia', 'anaemia', 'investigator-assessed progression-free survival', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0005423', 'cui_str': 'Biliary tract structure'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",450.0,0.736101,"Median progression-free survival was 6·5 months (80% CI 5·7-7·1) in the ramucirumab group, 7·0 months (6·2-7·1) in the merestinib group, and 6·6 months (5·6-6·8) in the pooled placebo group (ramucirumab vs placebo hazard ratio 1·12","[{'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences and Department of Medical Oncology, University of Manchester and The Christie NHS Foundation Trust, Manchester, UK. Electronic address: juan.valle@manchester.ac.uk.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Crystal S', 'Initials': 'CS', 'LastName': 'Denlinger', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Aiwu Ruth', 'Initials': 'AR', 'LastName': 'He', 'Affiliation': 'Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Li-Yuan', 'Initials': 'LY', 'LastName': 'Bai', 'Affiliation': 'China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Rashida', 'Initials': 'R', 'LastName': 'Orlova', 'Affiliation': 'China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Adeva', 'Affiliation': 'University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Li-Tzong', 'Initials': 'LT', 'LastName': 'Chen', 'Affiliation': 'National Health Research Institutes, Miaoli, Taiwan.'}, {'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Obermannova', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ettrich', 'Affiliation': 'Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Jen-Shi', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Linkou Chang Gung Memorial Hospital and Chang Gung University, Tao-Yuan, Taiwan.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, UK.'}, {'ForeName': 'Allicia C', 'Initials': 'AC', 'LastName': 'Girvan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jiangang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Chunlao', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Ebert', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Samuel C', 'Initials': 'SC', 'LastName': 'McNeely', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Moser', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Joana M', 'Initials': 'JM', 'LastName': 'Oliveira', 'Affiliation': 'Eli Lilly and Company, New York, NY, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carlesi', 'Affiliation': 'Eli Lilly and Company, Sesto Fiorentino, Florence, Italy.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Walgren', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00409-5']
1789,34605581,"Multifocal contact lens design, not addition power, affects accommodation responses in young adult myopes.","PURPOSE


Prolonged nearwork has been implicated in myopia progression. Accommodation responses of young-adult myopes wearing different multifocal contact lenses were compared.
METHODS


Twenty adults, 18-25 years, with myopia (spherical equivalent refraction -0.50 to -5.50 D, mean -2.1 ± 1.6 D) wore five lens types in random order: Proclear single vision distance (SV), MiSight concentric dual-focus +2.00 D Add (MS), Biofinity aspheric centre distance +1.50 D Add (CD1) and +2.50 D Add (CD2) (all Coopervision), and NaturalVue aspheric (Visioneering Technologies) (NVue). Using a Grand-Seiko WAN-5500 autorefractor with binocular correction and viewing right eye accommodative responses were measured after a 10 min adaptation period at 4.0, 1.0, 0.5, 0.33 and 0.25 m distances. Dynamic measurements were taken for 4 s at 6 Hz. Accommodative stimuli and responses were referenced to 4 m (i.e., refraction differences between 4 m and nearer distances). Accommodation lags and refraction instabilities (standard deviations of dynamic responses) were determined. For comparison, results were obtained for an absolute presbyopic eye, where trial lenses counteracted the accommodation stimulus.
RESULTS


For SV and MS, accommodation responses were similar to the stimulus values. For aspheric lenses CD1, CD2 and NVue, accommodation responses were approximately 1.0 D lower across the stimulus range than with SV and MS, and rates of change were approximately 0.84 D per 1 D stimulus change. MS produced greater refraction instabilities than other lenses. For the presbyope, changes in refraction matched the trial lenses, indicating that corrections due to measurement through the different lenses were not needed.
CONCLUSION


Reductions in accommodation response occurred in young myopes wearing aspheric multifocal contact lenses independent of the labelled 'add' power. The concentric dual-focus MS lens produced minimal lags but had greater instability than the other lenses. The results indicate that the mechanism of multifocal contact lenses slowing myopia progression is unlikely to be through relaxing accommodation, at least in young adults.",2021,"For aspheric lenses CD1, CD2 and NVue, accommodation responses were approximately 1.0 D lower across the stimulus range than with SV and MS, and rates of change were approximately 0.84 D per 1 D stimulus change.","['Twenty adults, 18-25\xa0years, with myopia (spherical equivalent refraction -0.50 to -5.50\xa0D, mean -2.1\xa0±\xa01.6\xa0D) wore five lens types in random order: Proclear single vision distance ', 'young adult myopes', 'young-adult myopes wearing different multifocal contact lenses']","['MS', 'SV), MiSight concentric dual-focus +2.00 D Add (MS), Biofinity aspheric centre distance +1.50 D Add (CD1) and +2.50 D Add (CD2) (all Coopervision), and NaturalVue aspheric (Visioneering Technologies) (NVue']","['Accommodation responses', 'Accommodative stimuli and responses', 'CD2 and NVue, accommodation responses', 'accommodation response', 'refraction instabilities', 'Accommodation lags and refraction instabilities (standard deviations of dynamic responses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}]","[{'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0108773', 'cui_str': 'Lymphocyte antigen CD2'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",20.0,0.0531165,"For aspheric lenses CD1, CD2 and NVue, accommodation responses were approximately 1.0 D lower across the stimulus range than with SV and MS, and rates of change were approximately 0.84 D per 1 D stimulus change.","[{'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Gifford', 'Affiliation': 'Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Schmid', 'Affiliation': 'Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Collins', 'Affiliation': 'Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Clare B', 'Initials': 'CB', 'LastName': 'Maher', 'Affiliation': 'Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Riya', 'Initials': 'R', 'LastName': 'Makan', 'Affiliation': 'Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Evonne', 'Initials': 'E', 'LastName': 'Nguyen', 'Affiliation': 'Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Gemma B', 'Initials': 'GB', 'LastName': 'Parmenter', 'Affiliation': 'Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Bronte M', 'Initials': 'BM', 'LastName': 'Rolls', 'Affiliation': 'Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Xinyue S', 'Initials': 'XS', 'LastName': 'Zhang', 'Affiliation': 'Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Atchison', 'Affiliation': 'Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Queensland, Australia.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12892']
1790,34609323,Noisy Galvanic Vestibular Stimulation Combined With a Multisensory Balance Program in Older Adults With Moderate to High Fall Risk: Protocol for a Feasibility Study for a Randomized Controlled Trial.,"BACKGROUND


Reduced mobility and falls are common among older adults. Balance retraining programs are effective in reducing falls and in improving balance and mobility. Noisy galvanic vestibular stimulation is a low-level electrical stimulation used to reduce the threshold for the firing of vestibular neurons via a mechanism of stochastic resonance.
OBJECTIVE


This study aims to determine the feasibility of using noisy galvanic vestibular stimulation to augment a balance training program for older adults at risk of falls. We hypothesize that noisy galvanic vestibular stimulation will enhance the effects of balance retraining in older adults at risk of falls.
METHODS


In this 3-armed randomized controlled trial, community dwelling older adults at risk of falling will be randomly assigned to a noisy galvanic vestibular stimulation plus balance program (noisy galvanic vestibular stimulation group), sham plus balance program (sham group), or a no treatment group (control). Participants will attend the exercise group twice a week for 8 weeks with assessment of balance and gait pretreatment, posttreatment, and at 3 months postintervention. Primary outcome measures include postural sway, measured by center of pressure velocity, area and root mean square, and gait parameters such as speed, step width, step variability, and double support time. Spatial memory will also be measured using the triangle completion task and the 4 Mountains Test.
RESULTS


Recruitment began in November 2020. Data collection and analysis are expected to be completed by December 2022.
CONCLUSIONS


This study will evaluate the feasibility of using noisy galvanic vestibular stimulation alongside balance retraining in older adults at risk of falls and will inform the design of a fully powered randomized controlled trial.
TRIAL REGISTRATION


New Zealand Clinical Trials Registry (ACTRN12620001172998); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379944.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/32085.",2021,"Primary outcome measures include postural sway, measured by center of pressure velocity, area and root mean square, and gait parameters such as speed, step width, step variability, and double support time.","['older adults at risk of falls', 'older adults', 'Older Adults With Moderate to High Fall Risk', 'community dwelling older adults at risk of falling']","['Noisy galvanic vestibular stimulation', 'noisy galvanic vestibular stimulation', 'noisy galvanic vestibular stimulation plus balance program (noisy galvanic vestibular stimulation group), sham plus balance program (sham group), or a no treatment group (control', 'noisy galvanic vestibular stimulation alongside balance retraining', 'balance training program', 'Noisy Galvanic Vestibular Stimulation Combined With a Multisensory Balance Program', 'Balance retraining programs']","['postural sway, measured by center of pressure velocity, area and root mean square, and gait parameters such as speed, step width, step variability, and double support time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.130961,"Primary outcome measures include postural sway, measured by center of pressure velocity, area and root mean square, and gait parameters such as speed, step width, step variability, and double support time.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McLaren', 'Affiliation': 'Rehabilitation Innovation Centre, School of Clinical Sciences, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Smith', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Biomedical Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lord', 'Affiliation': 'Rehabilitation Innovation Centre, School of Clinical Sciences, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Preet Kamal', 'Initials': 'PK', 'LastName': 'Kaur', 'Affiliation': 'Rehabilitation Innovation Centre, School of Clinical Sciences, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Biomedical Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Rehabilitation Innovation Centre, School of Clinical Sciences, Auckland University of Technology, Auckland, New Zealand.'}]",JMIR research protocols,['10.2196/32085']
1791,34607088,Diverse predictors of treatment response to active medication and placebo in gambling disorder.,"Gambling disorder creates a significant public health burden. Despite decades of clinical trials, there are no licensed pharmacological treatments for gambling disorder. Contributing factors to this are the high placebo response rates seen in clinical trials, the heterogeneity of the disorder and high rates of psychiatric comorbidities. Indeed, a number of demographic and clinical variables have previously been associated with altered responses to pharmacotherapy, psychotherapy and placebo. Which variables are likely to predict response to one modality over another remains uncertain. We carried out multiple linear regression analyses in a pooled dataset from six treatment studies in gambling disorder with the aim of identifying predictors of treatment response. Potential predictors were identified a priori through hypothesis and entered into models including all patients, and subsequently for those randomized to active medication or placebo separately. We found that baseline severity of gambling symptoms and number of weeks completed in a trial were predictors of active medication response, while decreased baseline symptoms of anxiety, increased baseline symptoms of depression, and non-Caucasian ethnicity were associated with placebo response. Sensitivity analyses showed that these associations were robust to choices made during the analysis. Further research is required to understand whether controlling for these variables, or using enriched samples, improves assay sensitivity in placebo-controlled clinical trials for gambling disorder.",2021,"We found that baseline severity of gambling symptoms and number of weeks completed in a trial were predictors of active medication response, while decreased baseline symptoms of anxiety, increased baseline symptoms of depression, and non-Caucasian ethnicity were associated with placebo response.",['gambling disorder'],['placebo'],"['assay sensitivity', 'baseline symptoms of anxiety, increased baseline symptoms of depression, and non-Caucasian ethnicity']","[{'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]",,0.294204,"We found that baseline severity of gambling symptoms and number of weeks completed in a trial were predictors of active medication response, while decreased baseline symptoms of anxiety, increased baseline symptoms of depression, and non-Caucasian ethnicity were associated with placebo response.","[{'ForeName': 'Nathan T M', 'Initials': 'NTM', 'LastName': 'Huneke', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, UK; University Department of Psychiatry, University of Southampton, UK; Southern Health National Health Service Foundation Trust, Southampton, UK. Electronic address: n.huneke@soton.ac.uk.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Chamberlain', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, UK; University Department of Psychiatry, University of Southampton, UK; Southern Health National Health Service Foundation Trust, Southampton, UK; Department of Psychiatry, University of Cambridge, UK.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Baldwin', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, UK; University Department of Psychiatry, University of Southampton, UK; Southern Health National Health Service Foundation Trust, Southampton, UK; University Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Grant', 'Affiliation': 'Department of Psychiatry & Behavioral Neuroscience, University of Chicago, Pritzker School of Medicine, Chicago, IL, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.09.053']
1792,34612840,An Intervention With Michigan-Grown Wheat in Healthy Adult Humans to Determine Effect on Gut Microbiota: Protocol for a Crossover Trial.,"BACKGROUND


Daily fiber intake can increase the diversity of the human gut microbiota as well as the abundance of beneficial microbes and their metabolites. Whole-grain wheat is high in fiber.
OBJECTIVE


This manuscript presents a study protocol designed to understand the effects of different types of wheat on gastrointestinal tract microbes.
METHODS


Human adults will consume crackers made from three types of wheat flour (refined soft white wheat, whole-grain soft white wheat, and whole-grain soft red wheat). In this study, participants will alternate between crackers made from refined soft white wheat flour to those made from whole-grain soft white wheat and whole-grain soft red wheat flour. Survey and stool sample collection will occur after 7-day treatment periods. We will assess how wheat consumption affects gastrointestinal bacteria by sequencing the V4 region of 16S rRNA gene amplicons and the inflammatory state of participants' intestines using enzyme-linked immunosorbent assays. The butyrate production capacity of the gut microbiota will be determined by targeted quantitative real-time polymerase chain reaction.
RESULTS


We will report the treatment effects on alpha and beta diversity of the microbiota and taxa-specific differences. Microbiota results will be analyzed using the vegan package in R. Butyrate production capacity and biomarkers of intestinal inflammation will be analyzed using parametric statistical methods such as analysis of variance or linear regression. We expect whole wheat intake to increase butyrate production capacity, bacterial alpha diversity, and abundance of bacterial taxa responsive to phenolic compounds. Soft red wheat is also expected to decrease the concentration of inflammatory biomarkers in the stool of participants.
CONCLUSIONS


This protocol describes the methods to be used in a study on the impact of wheat types on the human gastrointestinal microbiota and biomarkers of intestinal inflammation. The analysis of intestinal responses to the consumption of two types of whole wheat will expand our understanding of how specific foods affect health-associated outcomes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/29046.",2021,"We expect whole wheat intake to increase butyrate production capacity, bacterial alpha diversity, and abundance of bacterial taxa responsive to phenolic compounds.","['Human adults will consume crackers made from three types of wheat flour (refined soft white wheat, whole-grain soft white wheat, and whole-grain soft red wheat', 'Healthy Adult Humans']",[],"['concentration of inflammatory biomarkers', 'butyrate production capacity, bacterial alpha diversity, and abundance of bacterial taxa responsive to phenolic compounds']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0452505', 'cui_str': 'Cracker'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C0205198', 'cui_str': 'Compound'}]",,0.188344,"We expect whole wheat intake to increase butyrate production capacity, bacterial alpha diversity, and abundance of bacterial taxa responsive to phenolic compounds.","[{'ForeName': 'Gigi A', 'Initials': 'GA', 'LastName': 'Kinney', 'Affiliation': 'Department of Food Science & Human Nutrition, Michigan State University, East Lansing, MI, United States.'}, {'ForeName': 'Eliot N', 'Initials': 'EN', 'LastName': 'Haddad', 'Affiliation': 'Department of Food Science & Human Nutrition, Michigan State University, East Lansing, MI, United States.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Garrow', 'Affiliation': 'Department of Food Science & Human Nutrition, Michigan State University, East Lansing, MI, United States.'}, {'ForeName': 'Perry K W', 'Initials': 'PKW', 'LastName': 'Ng', 'Affiliation': 'Department of Food Science & Human Nutrition, Michigan State University, East Lansing, MI, United States.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Comstock', 'Affiliation': 'Department of Food Science & Human Nutrition, Michigan State University, East Lansing, MI, United States.'}]",JMIR research protocols,['10.2196/29046']
1793,34612836,Augmented Reality in Pediatric Septic Shock Simulation: Randomized Controlled Feasibility Trial.,"BACKGROUND


Septic shock is a low-frequency but high-stakes condition in children requiring prompt resuscitation, which makes it an important target for simulation-based education.
OBJECTIVE


In this study, we aimed to design and implement an augmented reality app (PediSepsisAR) for septic shock simulation, test the feasibility of measuring the timing and volume of fluid administration during septic shock simulation with and without PediSepsisAR, and describe PediSepsisAR as an educational tool. We hypothesized that we could feasibly measure our desired data during the simulation in 90% of the participants in each group. With regard to using PediSepsisAR as an educational tool, we hypothesized that the PediSepsisAR group would report that it enhanced their awareness of simulated patient blood flow and would more rapidly verbalize recognition of abnormal patient status and desired management steps.
METHODS


We performed a randomized controlled feasibility trial with a convenience sample of pediatric care providers at a large tertiary care pediatric center. Participants completed a prestudy questionnaire and were randomized to either the PediSepsisAR or control (traditional simulation) arms. We measured the participants' time to administer 20, 40, and 60 cc/kg of intravenous fluids during a septic shock simulation using each modality. In addition, facilitators timed how long participants took to verbalize they had recognized tachycardia, hypotension, or septic shock and desired to initiate the sepsis pathway and administer antibiotics. Participants in the PediSepsisAR arm completed a poststudy questionnaire. We analyzed data using descriptive statistics and a Wilcoxon rank-sum test to compare the median time with event variables between groups.
RESULTS


We enrolled 50 participants (n=25 in each arm). The timing and volume of fluid administration were captured in all the participants in each group. There was no statistically significant difference regarding time to administration of intravenous fluids between the two groups. Similarly, there was no statistically significant difference between the groups regarding time to verbalized recognition of patient status or desired management steps. Most participants in the PediSepsisAR group reported that PediSepsisAR enhanced their awareness of the patient's perfusion.
CONCLUSIONS


We developed an augmented reality app for use in pediatric septic shock simulations and demonstrated the feasibility of measuring the volume and timing of fluid administration during simulation using this modality. In addition, our findings suggest that PediSepsisAR may enhance participants' awareness of abnormal perfusion.",2021,"Similarly, there was no statistically significant difference between the groups regarding time to verbalized recognition of patient status or desired management steps.","['children requiring prompt resuscitation', 'convenience sample of pediatric care providers at a large tertiary care pediatric center', 'Pediatric Septic Shock Simulation', '50 participants (n=25 in each arm']","['PediSepsisAR or control (traditional simulation', 'augmented reality app (PediSepsisAR']","['recognized tachycardia, hypotension, or septic shock', ""PediSepsisAR enhanced their awareness of the patient's perfusion"", 'time to verbalized recognition of patient status or desired management steps']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3839839', 'cui_str': 'Pediatric care'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0449437', 'cui_str': 'Patient status'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",50.0,0.250878,"Similarly, there was no statistically significant difference between the groups regarding time to verbalized recognition of patient status or desired management steps.","[{'ForeName': 'Regina L', 'Initials': 'RL', 'LastName': 'Toto', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Ethan S', 'Initials': 'ES', 'LastName': 'Vorel', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Khoon-Yen E', 'Initials': 'KE', 'LastName': 'Tay', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Good', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Jesse M', 'Initials': 'JM', 'LastName': 'Berdinka', 'Affiliation': 'BrickSimple, LLC, Doylestown, PA, United States.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Peled', 'Affiliation': 'BrickSimple, LLC, Doylestown, PA, United States.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia, PA, United States.'}, {'ForeName': 'Todd P', 'Initials': 'TP', 'LastName': 'Chang', 'Affiliation': ""Division of Emergency Medicine & Transport, Children's Hospital Los Angeles, Los Angeles, CA, United States.""}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Weiss', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Frances B', 'Initials': 'FB', 'LastName': 'Balamuth', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}]",JMIR medical education,['10.2196/29899']
1794,34612663,Adjunctive Probiotics Alleviates Asthmatic Symptoms via Modulating the Gut Microbiome and Serum Metabolome.,"Asthma is a multifactorial disorder, and microbial dysbiosis enhances lung inflammation and asthma-related symptoms. Probiotics have shown anti-inflammatory effects and could regulate the gut-lung axis. Thus, a 3-month randomized, double-blind, and placebo-controlled human trial was performed to investigate the adjunctive efficacy of probiotics in managing asthma. Fifty-five asthmatic patients were randomly assigned to a probiotic group ( n  = 29; received Bifidobacterium lactis Probio-M8 powder and Symbicort Turbuhaler) and a placebo group ( n  = 26; received placebo and Symbicort Turbuhaler), and all 55 subjects provided details of their clinical history and demographic data. However, only 31 patients donated a complete set of fecal and blood samples at all three time points for further analysis. Compared with those of the placebo group, co-administering Probio-M8 with Symbicort Turbuhaler significantly decreased the fractional exhaled nitric oxide level at day 30 ( P  = 0.049) and improved the asthma control test score at the end of the intervention ( P  = 0.023). More importantly, the level of alveolar nitric oxide concentration decreased significantly among the probiotic receivers at day 30 ( P  = 0.038), and the symptom relief effect was even more obvious at day 90 ( P  = 0.001). Probiotic co-administration increased the resilience of the gut microbiome, which was reflected by only minor fluctuations in the gut microbiome diversity ( P  > 0.05, probiotic receivers;  P  < 0.05, placebo receivers). Additionally, the probiotic receivers showed significantly changes in some species-level genome bins (SGBs), namely, increases in potentially beneficial species Bifidobacterium animalis, Bifidobacterium longum, and  Prevotella  sp. CAG and decreases in Parabacteroides distasonis and  Clostridiales bacterium  ( P  < 0.05). Compared with that of the placebo group, the gut metabolic potential of probiotic receivers exhibited increased levels of predicted microbial bioactive metabolites (linoleoyl ethanolamide, adrenergic acid, erythronic acid) and serum metabolites (5-dodecenoic acid, tryptophan, sphingomyelin) during/after intervention. Collectively, our results suggested that co-administering Probio-M8 synergized with conventional therapy to alleviate diseases associated with the gut-lung axis, like asthma, possibly via activating multiple anti-inflammatory pathways.  IMPORTANCE  The human gut microbiota has a potential effect on the pathogenesis of asthma and is closely related to the disease phenotype. Our trial has demonstrated that co-administering Probio-M8 synergized with conventional therapy to alleviate asthma symptoms. The findings of the present study provide new insights into the pathogenesis and treatment of asthma, mechanisms of novel therapeutic strategies, and application of probiotics-based therapy.",2021,"Probiotic co-administration increased the resilience of the gut microbiome, which was reflected by only minor fluctuations in the gut microbiome diversity ( P  > 0.05, probiotic receivers;  P  ",['Fifty-five asthmatic patients'],"['probiotic group', 'Probiotics', 'placebo and Symbicort Turbuhaler', 'Bifidobacterium lactis Probio-M8 powder and Symbicort Turbuhaler', 'placebo']","['Parabacteroides distasonis and  Clostridiales bacterium', 'levels of predicted microbial bioactive metabolites (linoleoyl ethanolamide, adrenergic acid, erythronic acid) and serum metabolites (5-dodecenoic acid, tryptophan, sphingomyelin', 'symptom relief effect', 'resilience of the gut microbiome', 'asthma control test score', 'level of alveolar nitric oxide concentration', 'complete set of fecal and blood samples', 'fractional exhaled nitric oxide level']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1121854', 'cui_str': 'Symbicort'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C1927848', 'cui_str': 'Parabacteroides'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0668454', 'cui_str': 'linoleoyl ethanolamide'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0909393', 'cui_str': 'erythronic acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0175152', 'cui_str': '5-dodecenoic acid'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0037906', 'cui_str': 'Sphingomyelin'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}]",55.0,0.132759,"Probiotic co-administration increased the resilience of the gut microbiome, which was reflected by only minor fluctuations in the gut microbiome diversity ( P  > 0.05, probiotic receivers;  P  ","[{'ForeName': 'Ailing', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong Universitygrid.27255.37, Weihai, Shandong, China.'}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': 'Inner Mongolia Key Laboratory of Dairy Biotechnology and Engineering, Inner Mongolia Agricultural Universitygrid.411638.9, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong Universitygrid.27255.37, Weihai, Shandong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Inner Mongolia Key Laboratory of Dairy Biotechnology and Engineering, Inner Mongolia Agricultural Universitygrid.411638.9, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Feiyan', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Inner Mongolia Key Laboratory of Dairy Biotechnology and Engineering, Inner Mongolia Agricultural Universitygrid.411638.9, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Lai-Yu', 'Initials': 'LY', 'LastName': 'Kwok', 'Affiliation': 'Inner Mongolia Key Laboratory of Dairy Biotechnology and Engineering, Inner Mongolia Agricultural Universitygrid.411638.9, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Inner Mongolia Key Laboratory of Dairy Biotechnology and Engineering, Inner Mongolia Agricultural Universitygrid.411638.9, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Shukun', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong Universitygrid.27255.37, Weihai, Shandong, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Inner Mongolia Key Laboratory of Dairy Biotechnology and Engineering, Inner Mongolia Agricultural Universitygrid.411638.9, Hohhot, Inner Mongolia, China.'}]",Microbiology spectrum,['10.1128/Spectrum.00859-21']
1795,34610830,Atherogenic index of plasma is associated with major adverse cardiovascular events in patients with type 2 diabetes mellitus.,"BACKGROUND


Previous studies reported the prognostic value of the atherogenic index of plasma (AIP) in the course of atherosclerosis and other cardiovascular diseases (CVDs). Still, the predictive utility of the AIP is unknown among patients with type 2 diabetes mellitus (T2DM).
METHODS


This was a secondary analysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, which randomized 10,251 patients with long-lasting T2DM. ROC curve analysis was used to determine an optimal threshold for AIP, and the study population was divided into high and low AIP groups. Univariable and multivariable Cox proportional hazards regression analyses were used to determine the association between AIP and primary (major adverse cardiovascular events [MACEs], including nonfatal myocardial infarction, nonfatal stroke, and/or death from cardiovascular causes) and secondary outcomes (all-cause mortality). Stratified analyses were performed to control for the confounding factors.
RESULTS


AIP was an independent risk factor for the prognosis of T2DM (HR = 1.309; 95% CI 1.084-1.581; P = 0.005). The threshold for AIP was determined to be 0.34 in the study population. After adjustments for confounding factors, multivariable analysis showed that AIP was associated with the risk of MACEs (Model 1: HR = 1.333, 95% CI 1.205-1.474, P < 0.001; Model 2: HR = 1.171, 95% CI 1.030-1.333, P = 0.016; Model 3: HR = 1.194, 95% CI 1.049-1.360, P = 0.007), all-cause mortality (Model 1: HR = 1.184, 95% CI 1.077-1.303, P < 0.001), cardiovascular death (Model 1: HR = 1.422, 95% CI 1.201-1.683, P < 0.001; Model 3: HR = 1.264, 95% CI 1.015-1.573, P = 0.036), and nonfatal myocardial infarction (Model 1: HR = 1.447, 95% CI 1.255-1.669, P < 0.001; Model 2: HR = 1.252, 95% CI 1.045-1.499, P = 0.015; Model 3: HR = 1.284, 95% CI 1.071-1.539, P = 0.007). Subgroup stratified analyses showed that AIP might interact with sex, a classical risk factor of cardiovascular events.
CONCLUSIONS


This study showed that AIP might be a strong biomarker that could be used to predict the risk of cardiovascular events in patients with T2DM.
TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov . Unique identifier: NCT00000620.",2021,AIP was an independent risk factor for the prognosis of T2DM (HR = 1.309; 95% CI 1.084-1.581; P = 0.005).,"['patients with type 2 diabetes mellitus', 'patients with T2DM', '10,251 patients with long-lasting T2DM', 'patients with type 2 diabetes mellitus (T2DM']",[],"['cardiovascular death', 'Atherogenic index of plasma', 'risk of MACEs', 'nonfatal myocardial infarction', 'nonfatal myocardial infarction, nonfatal stroke, and/or death from cardiovascular causes) and secondary outcomes (all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]",[],"[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",10251.0,0.133075,AIP was an independent risk factor for the prognosis of T2DM (HR = 1.309; 95% CI 1.084-1.581; P = 0.005).,"[{'ForeName': 'Liyao', 'Initials': 'L', 'LastName': 'Fu', 'Affiliation': 'Department of Blood Transfusion, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Blood Transfusion, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiovascular Medicine, The Second Xiangya Hospital of Central South University, No. 139, Middle Renmin Road, Changsha, 410011, Hunan, People's Republic of China.""}, {'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Department of Cardiovascular Medicine, The Second Xiangya Hospital of Central South University, No. 139, Middle Renmin Road, Changsha, 410011, Hunan, People's Republic of China.""}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xing', 'Affiliation': ""Department of Cardiovascular Medicine, The Second Xiangya Hospital of Central South University, No. 139, Middle Renmin Road, Changsha, 410011, Hunan, People's Republic of China.""}, {'ForeName': 'Shenghua', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ""Department of Cardiovascular Medicine, The Second Xiangya Hospital of Central South University, No. 139, Middle Renmin Road, Changsha, 410011, Hunan, People's Republic of China.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Blood Transfusion, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Tai', 'Affiliation': ""Department of Cardiovascular Medicine, The Second Xiangya Hospital of Central South University, No. 139, Middle Renmin Road, Changsha, 410011, Hunan, People's Republic of China. taishi2017@csu.edu.cn.""}]",Cardiovascular diabetology,['10.1186/s12933-021-01393-5']
1796,34610519,Advancing our understanding of the intersection between emotion regulation and alcohol and drug use problems: Dyadic analysis in couples with intimate partner violence and alcohol use disorder.,"BACKGROUND


An extensive body of literature has linked emotion regulation to alcohol and drug use problems, including among populations characterized by intimate partner violence (IPV). Advancing this research, the goal of the current study was to examine cognitive emotion regulation strategies and alcohol and drug use problems within a dyadic framework. Specifically, we examined actor and partner effects of maladaptive and adaptive cognitive emotion regulation strategies on alcohol and drug use problems.
METHODS


Eighty-four romantic couples (N = 168 total participants) participating in a randomized controlled trial who reported physical IPV and an alcohol use disorder completed self-reported measures of cognitive emotion regulation as well as alcohol and drug use problems.
RESULTS


Regarding actor effects, men's greater use of maladaptive cognitive emotion regulation strategies was positively related to their alcohol use problems (p < .001), whereas both women's (p = .02) and men's (p = .047) greater use of adaptive cognitive emotion regulation strategies was negatively related to their own alcohol use problems. In terms of partner effects, men's greater use of maladaptive cognitive emotion regulation strategies (p = .001) and less use of adaptive cognitive emotion regulation strategies (p = .017) was related to their partners' greater drug use problems.
CONCLUSIONS


Findings replicate and extend existing work in this area, showing that men's and women's emotion regulation strategies are related to their own alcohol and drug use problems and that men's cognitive emotion regulation strategies are also related to their partners' drug use problems.",2021,"In terms of partner effects, men's greater use of maladaptive cognitive emotion regulation strategies (p = .001) and less use of adaptive cognitive emotion regulation strategies (p = .017) was related to their partners' greater drug use problems.
","['Eighty-four romantic couples (N\xa0=\xa0168 total participants) participating', 'couples with intimate partner violence and alcohol use disorder']",['physical IPV and an alcohol use disorder completed self-reported measures of cognitive emotion regulation as well as alcohol and drug use problems'],"['adaptive cognitive emotion regulation strategies', 'maladaptive cognitive emotion regulation strategies']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",168.0,0.0121179,"In terms of partner effects, men's greater use of maladaptive cognitive emotion regulation strategies (p = .001) and less use of adaptive cognitive emotion regulation strategies (p = .017) was related to their partners' greater drug use problems.
","[{'ForeName': 'Nicole H', 'Initials': 'NH', 'LastName': 'Weiss', 'Affiliation': 'University of Rhode Island, USA.'}, {'ForeName': 'Jasara', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Medical University of South Carolina, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Brem', 'Affiliation': 'Virginia Polytechnic Institute and State University, USA.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Massa', 'Affiliation': 'Ralph H. Johnson VAMC, USA.'}, {'ForeName': 'Charli M', 'Initials': 'CM', 'LastName': 'Kirby', 'Affiliation': 'Medical University of South Carolina, USA.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Medical University of South Carolina, USA; Ralph H. Johnson VAMC, USA. Electronic address: hellmuth@musc.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109066']
1797,34610099,Pressure Support versus Spontaneous Ventilation during Anesthetic Emergence-Effect on Postoperative Atelectasis: A Randomized Controlled Trial.,"BACKGROUND


Despite previous reports suggesting that pressure support ventilation facilitates weaning from mechanical ventilation in the intensive care unit, few studies have assessed its effects on recovery from anesthesia. The authors hypothesized that pressure support ventilation during emergence from anesthesia reduces postoperative atelectasis in patients undergoing laparoscopic surgery using the Trendelenburg position.
METHODS


In this randomized controlled double-blinded trial, adult patients undergoing laparoscopic colectomy or robot-assisted prostatectomy were assigned to either the pressure support (n = 50) or the control group (n = 50). During emergence (from the end of surgery to extubation), pressure support ventilation was used in the pressure support group versus intermittent manual assistance in the control group. The primary outcome was the incidence of atelectasis diagnosed by lung ultrasonography at the postanesthesia care unit (PACU). The secondary outcomes were Pao2 at PACU and oxygen saturation measured by pulse oximetry less than 92% during 48 h postoperatively.
RESULTS


Ninety-seven patients were included in the analysis. The duration of emergence was 9 min and 8 min in the pressure support and control groups, respectively. The incidence of atelectasis at PACU was lower in the pressure support group compared to that in the control group (pressure support vs. control, 16 of 48 [33%] vs. 28 of 49 [57%]; risk ratio, 0.58; 95% CI, 0.35 to 0.91; P = 0.024). In the PACU, Pao2 in the pressure support group was higher than that in the control group (92 ± 26 mmHg vs. 83 ± 13 mmHg; P = 0.034). The incidence of oxygen saturation measured by pulse oximetry less than 92% during 48 h postoperatively was not different between the groups (9 of 48 [19%] vs. 11 of 49 [22%]; P = 0.653). There were no adverse events related to the study protocol.
CONCLUSIONS


The incidence of postoperative atelectasis was lower in patients undergoing either laparoscopic colectomy or robot-assisted prostatectomy who received pressure support ventilation during emergence from general anesthesia compared to those receiving intermittent manual assistance.
EDITOR’S PERSPECTIVE


",2021,"The incidence of postoperative atelectasis was lower in patients undergoing either laparoscopic colectomy or robot-assisted prostatectomy who received pressure support ventilation during emergence from general anesthesia compared to those receiving intermittent manual assistance.
","['patients undergoing laparoscopic surgery using the Trendelenburg position', 'adult patients undergoing', 'patients undergoing either', 'Ninety-seven patients were included in the analysis']","['laparoscopic colectomy or robot-assisted prostatectomy who received pressure support ventilation', 'pressure support ventilation', 'pressure support', 'laparoscopic colectomy or robot-assisted prostatectomy', 'Pressure Support versus Spontaneous Ventilation']","['incidence of atelectasis diagnosed by lung ultrasonography at the postanesthesia care unit (PACU', 'incidence of oxygen saturation', 'Postoperative Atelectasis', 'duration of emergence', 'incidence of atelectasis at PACU', 'postoperative atelectasis', 'Pao2 at PACU and oxygen saturation measured by pulse oximetry less']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0277812', 'cui_str': 'Trendelenburg position'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0203463', 'cui_str': 'Ultrasonography of lung'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0340074', 'cui_str': 'Postoperative atelectasis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}]",97.0,0.344146,"The incidence of postoperative atelectasis was lower in patients undergoing either laparoscopic colectomy or robot-assisted prostatectomy who received pressure support ventilation during emergence from general anesthesia compared to those receiving intermittent manual assistance.
","[{'ForeName': 'Heejoon', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Pisitpitayasaree', 'Initials': 'P', 'LastName': 'Tanatporn', 'Affiliation': 'the Department of Anesthesiology, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Hyun Joo', 'Initials': 'HJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Mikyung', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jie Ae', 'Initials': 'JA', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyean', 'Initials': 'H', 'LastName': 'Yeo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Woojin', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}]",Anesthesiology,['10.1097/ALN.0000000000003997']
1798,34609956,"Short and long-term outcomes of video observed treatment in tuberculosis patients, the Republic of Moldova.","INTRODUCTION


The Republic of Moldova is among the 18 high priority countries for tuberculosis (TB) in Europe. This study compared adherence and short and long-term TB treatment outcomes for TB patients who experienced asynchronous Video Observed Treatment (aVOT) during three months of outpatient treatment versus Directly Observed Treatment (DOT) in operational conditions in 2016-2017 in Chisinau.
METHODOLOGY


We used secondary data from the 2016-2017 Randomized Clinical Trial (RCT) that piloted the aVOT Strategy in Chisinau and data from the national TB register. Relative risk was selected as a measure of association in analysis of treatment strategies (aVOT and DOT under operational conditions) and short and long-term treatment outcomes.
RESULTS


From 647 TB patients included in the study, 169 followed the treatment strategy in the RCT (83 in aVOT and 86 in DOT) and 478 were on DOT in operational conditions. Those in aVOT were more likely to have favourable short-term outcome than patients with DOT in operational conditions (RR 0.07; p < 0.001). TB recurrence as an indicator for the long-term outcome, was observed in group with DOT in operational conditions (40 cases, p = 0.006).
CONCLUSIONS


This study demonstrated that the aVOT treatment strategy was associated with better adherence and both short and long-term TB treatment favourable outcomes. aVOT as a new patient-centred approach supporting TB patients on improving treatment adherence and outcomes might be recommended as an alternative to DOT strategy in the Republic of Moldova.",2021,This study demonstrated that the aVOT treatment strategy was associated with better adherence and both short and long-term TB treatment favourable outcomes.,"['647 TB patients included in the study', 'tuberculosis patients, the Republic of Moldova', 'TB patients who experienced asynchronous Video Observed Treatment (aVOT) during three months of outpatient treatment versus Directly Observed Treatment (DOT) in operational conditions in 2016-2017 in Chisinau', '18 high priority countries for tuberculosis (TB) in Europe']",['aVOT'],['TB recurrence'],"[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026374', 'cui_str': 'Moldavia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1273516', 'cui_str': 'High priority'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.104456,This study demonstrated that the aVOT treatment strategy was associated with better adherence and both short and long-term TB treatment favourable outcomes.,"[{'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Doltu', 'Affiliation': ""NGO 'AFI', Chisinau, Republic of Moldova. svetlana.doltu@gmail.com.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ciobanu', 'Affiliation': 'WHO Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Yuliia', 'Initials': 'Y', 'LastName': 'Sereda', 'Affiliation': 'Independent Consultant, Kyiv, Ukraine.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Persian', 'Affiliation': 'The Behavioural Insight Teams, London, United Kingdom.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Ravenscroft', 'Affiliation': 'The Behavioural Insight Teams, London, United Kingdom.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Kasyan', 'Affiliation': 'American University of Armenia, Erevan, Republic of Armenia.'}, {'ForeName': 'Nune', 'Initials': 'N', 'LastName': 'Truzyan', 'Affiliation': 'American University of Armenia, Erevan, Republic of Armenia.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Dadu', 'Affiliation': 'WHO Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Reid', 'Affiliation': 'Médecins Sans Frontières, Brussels, Belgium.'}]",Journal of infection in developing countries,['10.3855/jidc.14601']
1799,34619515,Two-year fixation and ten-year clinical outcomes of total knee arthroplasty inserted with normal-curing bone cement and slow-curing bone cement: A randomized controlled trial in 54 patients.,"BACKGROUND


The normal-curing Refobacin® Bone Cement R (RR) and slow-curing Refobacin® Plus Bone Cement (RP) were introduced after discontinuation of the historically most used bone cement, Refobacin®-Palacos® R, in 2005. The aim of this study was to compare total knee arthroplasty component fixation with the two bone cements.
METHODS


54 patients with primary knee osteoarthritis were randomized to either RR (N = 27) or RP (N = 27) bone cement and followed for two years with radiostereometric analysis of tibial and femoral component migration and dual-energy x-ray absorptiometry measured periprosthetic bone mineral density (BMD). Further, patients were followed up at ten years with clinical outcome scores (OKS and KOOS).
RESULTS


At two-years follow-up, tibial total translation was 0.31 mm (95% CI: 0.19 - 0.42) for the RP group and 0.56 mm (95% CI: 0.45 - 0.67) (p < 0.01) for the RR group. There was continuous tibial component migration from one to two years follow-up (MTPM > 0.2 mm) in 13/27 patients from the RR and in 12/26 patients from the RP group. There was no difference between groups in BMD baseline values or changes during follow-up, as well as no correlation between change in BMD and tibial component migration. At ten-years follow-up, the improvement in the clinical outcome scores was similar between groups. There were no prosthesis related complications during the 10-year follow-up.
CONCLUSION


At two years, tibial total translation was lower in the RP compared with the RR cement group, but BMD changes were similar. At ten years, no components were revised and clinical outcome scores were similar between groups.",2021,There was continuous tibial component migration from one to two years follow-up (MTPM > 0.2 mm) in 13/27 patients from the RR and in 12/26 patients from the RP group.,"['54 patients with primary knee osteoarthritis', '54 patients']","['total knee arthroplasty inserted with normal-curing bone cement and slow-curing bone cement', 'Refobacin® Bone Cement R (RR) and slow-curing Refobacin® Plus Bone Cement (RP', 'RR (N\xa0=\xa027) or RP']","['BMD baseline values', 'continuous tibial component migration', 'clinical outcome scores (OKS and KOOS', 'total knee arthroplasty component fixation', 'BMD and tibial component migration', 'tibial total translation', 'periprosthetic bone mineral density (BMD', 'clinical outcome scores', 'BMD changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0140146', 'cui_str': 'refobacin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0730418', 'cui_str': 'Component fixation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",54.0,0.0914238,There was continuous tibial component migration from one to two years follow-up (MTPM > 0.2 mm) in 13/27 patients from the RR and in 12/26 patients from the RP group.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Breddam Mosegaard', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark. Electronic address: sebmos@rm.dk.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rytter', 'Affiliation': 'Department of Orthopaedic Surgery, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark. Electronic address: soeren.rytter@rm.dk.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Madsen', 'Affiliation': 'Department of Orthopaedic Surgery, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark. Electronic address: franmads@rm.dk.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Odgaard', 'Affiliation': 'Department of Orthopaedic Surgery, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark. Electronic address: anders.odgaard@regionh.dk.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Søballe', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark; Department of Orthopaedic Surgery, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Maiken', 'Initials': 'M', 'LastName': 'Stilling', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark; Department of Orthopaedic Surgery, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark. Electronic address: maiken.stilling@clin.au.dk.'}]",The Knee,['10.1016/j.knee.2021.08.027']
1800,34619441,One-day acceptance and commitment therapy (ACT) workshop improves anxiety but not vascular function or inflammation in adults with moderate to high anxiety levels in a randomized controlled trial.,"OBJECTIVE


Acceptance and Commitment Therapy (ACT) is a behavioral intervention demonstrating sustained improvements in anxiety in individuals with chronic anxiety and psychological distress. Because anxiety disorders are associated with the development of cardiovascular disease (CVD), we hypothesized that a novel 1-day ACT workshop would both lower anxiety and improve vascular function in persons with moderate/high anxiety.
METHODS


In a randomized controlled study, 72 adults (age 33.9 ± 8.6 (SD) years) with baseline moderate/high anxiety completed a one-day ACT intervention (n = 44, age 33.9 ± 8.7 years) or control (n = 28, age 37.1 ± 10.1 years). Pre-specified secondary outcomes were measured over 12 weeks: aortic stiffness (carotid-femoral pulse wave velocity [cfPWV]), forearm vascular endothelial function (post-ischemic peak forearm blood flow [FBF] via plethysmography), and brachial artery flow-mediated dilation (FMD). Carotid artery stiffness (β-stiffness index), and inflammatory markers (C-reactive protein and tumor necrosis factor-alpha) were also explored.
RESULTS


Although the intervention had a significant and sustained effect on the primary outcome of anxiety as measured by the Beck Anxiety Inventory, the 1-day ACT workshop was not associated with improvement in vascular or inflammatory endpoints. The intervention was unexpectedly associated with increases in β-stiffness index that were also associated with changing trait anxiety.
CONCLUSION


Anxiety improvements did not translate into improvements in any of the vascular function outcomes. This may reflect a less-than-robust effect of the intervention on anxiety, failure in design to select those with vascular dysfunction, or not intervening on a relevant causal pathway. (Trial registration NCT02915874 at www.clinicaltrials.gov).",2021,"Although the intervention had a significant and sustained effect on the primary outcome of anxiety as measured by the Beck Anxiety Inventory, the 1-day ACT workshop was not associated with improvement in vascular or inflammatory endpoints.","['individuals with chronic anxiety and psychological distress', 'persons with moderate/high anxiety', '72 adults (age 33.9\xa0±\xa08.6 (SD) years) with baseline moderate/high anxiety completed a one-day ACT intervention (n\xa0=\xa044, age 33.9\xa0±\xa08.7\xa0years) or control (n\xa0=\xa028, age 37.1\xa0±\xa010.1\xa0years', 'adults with moderate to high anxiety levels']","['Commitment Therapy (ACT', 'commitment therapy (ACT) workshop']","['Beck Anxiety Inventory', 'anxiety', 'vascular function', 'vascular or inflammatory endpoints', 'Carotid artery stiffness (β-stiffness index), and inflammatory markers (C-reactive protein and tumor necrosis factor-alpha', 'aortic stiffness (carotid-femoral pulse wave velocity [cfPWV]), forearm vascular endothelial function (post-ischemic peak forearm blood flow [FBF] via plethysmography), and brachial artery flow-mediated dilation (FMD', 'β-stiffness index']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0581386', 'cui_str': 'Chronic anxiety'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",72.0,0.106212,"Although the intervention had a significant and sustained effect on the primary outcome of anxiety as measured by the Beck Anxiety Inventory, the 1-day ACT workshop was not associated with improvement in vascular or inflammatory endpoints.","[{'ForeName': 'Jess G', 'Initials': 'JG', 'LastName': 'Fiedorowicz', 'Affiliation': 'The Ottawa Hospital, Ottawa Hospital Research Institute, Brain and Mind Research Institute, University of Ottawa, Ottawa, ON, Canada. Electronic address: jfiedorowicz@toh.ca.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Dindo', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Tiwaloluwa', 'Initials': 'T', 'LastName': 'Ajibewa', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Persons', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marchman', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Seth W', 'Initials': 'SW', 'LastName': 'Holwerda', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Oluchi J', 'Initials': 'OJ', 'LastName': 'Abosi', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Lyndsey E', 'Initials': 'LE', 'LastName': 'DuBose', 'Affiliation': 'University of Colorado - Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Nealy', 'Initials': 'N', 'LastName': 'Wooldridge', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Stroud', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Dubishar', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Zhuangzhuang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Pierce', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2021.09.009']
1801,34623205,Enhanced recognition of emotional images is not affected by post-exposure exercise-induced arousal.,"Research suggests that aerobic exercise (i.e., exercise aiming to improve cardiovascular fitness) promotes cognition, but the impact on memory specifically, is unclear. There is some evidence to suggest that as little as one session of post-learning exercise benefits memory consolidation. Furthermore, memory may be particularly facilitated by exercise when the individual is emotionally aroused while encoding stimuli. The current study tested whether exercise after exposure to neutral and emotional images improved memory consolidation of the items among university students. Ninety-nine students were randomly instructed to either exercise or not exercise after viewing a set of images that were positive, neutral, and negative in valence, and they were later tested on their memory. Although emotional images were remembered better than non-emotional images, the results suggested that exercise did not influence this effect or enhance consolidation of the items overall. Explanations and implications for these findings are discussed.",2021,"Although emotional images were remembered better than non-emotional images, the results suggested that exercise did not influence this effect or enhance consolidation of the items overall.","['university students', 'Ninety-nine students']","['exercise or not exercise', 'aerobic exercise']",['Enhanced Recognition of Emotional Images'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3828813', 'cui_str': '99'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",99.0,0.0280901,"Although emotional images were remembered better than non-emotional images, the results suggested that exercise did not influence this effect or enhance consolidation of the items overall.","[{'ForeName': 'Veronica M', 'Initials': 'VM', 'LastName': 'Smith', 'Affiliation': 'School of Psychology, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Poppy', 'Initials': 'P', 'LastName': 'Watson', 'Affiliation': 'School of Psychology, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Most', 'Affiliation': 'School of Psychology, UNSW Sydney, Sydney, NSW, Australia.'}]",Quarterly journal of experimental psychology (2006),['10.1177/17470218211054950']
1802,34621054,"Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial.","Human immunodeficiency virus (HIV)-1-specific broadly neutralizing monoclonal antibodies are currently under development to treat and prevent HIV-1 infection. We performed a single-center, randomized, double-blind, dose-escalation, placebo-controlled trial of a single administration of the HIV-1 V3-glycan-specific antibody PGT121 at 3, 10 and 30 mg kg -1  in HIV-uninfected adults and HIV-infected adults on antiretroviral therapy (ART), as well as a multicenter, open-label trial of one infusion of PGT121 at 30 mg kg -1  in viremic HIV-infected adults not on ART (no. NCT02960581). The primary endpoints were safety and tolerability, pharmacokinetics (PK) and antiviral activity in viremic HIV-infected adults not on ART. The secondary endpoints were changes in anti-PGT121 antibody titers and CD4 +  T-cell count, and development of HIV-1 sequence variations associated with PGT121 resistance. Among 48 participants enrolled, no treatment-related serious adverse events, potential immune-mediated diseases or Grade 3 or higher adverse events were reported. The most common reactions among PGT121 recipients were intravenous/injection site tenderness, pain and headache. Absolute and relative CD4 +  T-cell counts did not change following PGT121 infusion in HIV-infected participants. Neutralizing anti-drug antibodies were not elicited. PGT121 reduced plasma HIV RNA levels by a median of 1.77 log in viremic participants, with a viral load nadir at a median of 8.5 days. Two individuals with low baseline viral loads experienced ART-free viral suppression for ≥168 days following antibody infusion, and rebound viruses in these individuals demonstrated full or partial PGT121 sensitivity. The trial met the prespecified endpoints. These data suggest that further investigation of the potential of antibody-based therapeutic strategies for long-term suppression of HIV is warranted, including in individuals off ART and with low viral load.",2021,PGT121 reduced plasma HIV RNA levels by a median of 1.77 ,['HIV-uninfected adults and HIV-infected adults on antiretroviral therapy (ART'],"['placebo', 'HIV-1 V3-glycan-specific antibody PGT121', 'PGT121']","['safety and tolerability, pharmacokinetics (PK) and antiviral activity in viremic HIV-infected adults not on ART', 'intravenous/injection site tenderness, pain and headache', 'changes in anti-PGT121 antibody titers and CD4 + \u2009T-cell count, and development of HIV-1 sequence variations associated with PGT121 resistance', 'serious adverse events, potential immune-mediated diseases or Grade\u20093 or higher adverse events', 'Safety, pharmacokinetics and antiviral activity', 'Absolute and relative CD4 + \u2009T-cell counts', 'plasma HIV RNA levels']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0863083', 'cui_str': 'Injection site tenderness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",2.0,0.823174,PGT121 reduced plasma HIV RNA levels by a median of 1.77 ,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Julg', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Zash', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Charlotte-Paige', 'Initials': 'CP', 'LastName': 'Rolle', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Ana N', 'Initials': 'AN', 'LastName': 'Monczor', 'Affiliation': 'McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Lupo', 'Affiliation': 'McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Huub C', 'Initials': 'HC', 'LastName': 'Gelderblom', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lori F', 'Initials': 'LF', 'LastName': 'Maxfield', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Abbink', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jinyan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Nityanandam', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Zijin', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Setaro', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sapiente', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Zhilin', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sunner', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Cassidy', 'Affiliation': 'Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.'}, {'ForeName': 'Chelsey', 'Initials': 'C', 'LastName': 'Bennett', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Mayer', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Perelson', 'Affiliation': 'Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'deCamp', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Frances H', 'Initials': 'FH', 'LastName': 'Priddy', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA.'}, {'ForeName': 'Kshitij', 'Initials': 'K', 'LastName': 'Wagh', 'Affiliation': 'Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.'}, {'ForeName': 'Elena E', 'Initials': 'EE', 'LastName': 'Giorgi', 'Affiliation': 'Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Roberto C', 'Initials': 'RC', 'LastName': 'Arduino', 'Affiliation': 'McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'DeJesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Bette', 'Initials': 'B', 'LastName': 'Korber', 'Affiliation': 'Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA. dbarouch@bidmc.harvard.edu.'}]",Nature medicine,['10.1038/s41591-021-01509-0']
1803,34621052,"Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial.","Nonalcoholic steatohepatitis (NASH), a chronic liver disease without an approved therapy, is associated with lipotoxicity and insulin resistance and is a major cause of cirrhosis and hepatocellular carcinoma. Aramchol, a partial inhibitor of hepatic stearoyl-CoA desaturase (SCD1) improved steatohepatitis and fibrosis in rodents and reduced steatosis in an early clinical trial. ARREST, a 52-week, double-blind, placebo-controlled, phase 2b trial randomized 247 patients with NASH (n = 101, n = 98 and n = 48 in the Aramchol 400 mg, 600 mg and placebo arms, respectively; NCT02279524 ). The primary end point was a decrease in hepatic triglycerides by magnetic resonance spectroscopy at 52 weeks with a dose of 600 mg of Aramchol. Key secondary end points included liver histology and alanine aminotransferase (ALT). Aramchol 600 mg produced a placebo-corrected decrease in liver triglycerides without meeting the prespecified significance (-3.1, 95% confidence interval (CI) -6.4 to 0.2, P = 0.066), precluding further formal statistical analysis. NASH resolution without worsening fibrosis was achieved in 16.7% (13 out of 78) of Aramchol 600 mg versus 5% (2 out of 40) of the placebo arm (odds ratio (OR) = 4.74, 95% CI = 0.99 to 22.7) and fibrosis improvement by ≥1 stage without worsening NASH in 29.5% versus 17.5% (OR = 1.88, 95% CI = 0.7 to 5.0), respectively. The placebo-corrected decrease in ALT for 600 mg was -29.1 IU l -1  (95% CI = -41.6 to -16.5). Early termination due to adverse events (AEs) was <5%, and Aramchol 600 and 400 mg were safe, well tolerated and without imbalance in serious or severe AEs between arms. Although the primary end point of a reduction in liver fat did not meet the prespecified significance level with Aramchol 600 mg, the observed safety and changes in liver histology and enzymes provide a rationale for SCD1 modulation as a promising therapy for NASH and fibrosis and are being evaluated in an ongoing phase 3 program.",2021,"NASH resolution without worsening fibrosis was achieved in 16.7% (13 out of 78) of Aramchol 600 mg versus 5% (2 out of 40) of the placebo arm (odds ratio (OR) = 4.74, 95% CI = 0.99 to 22.7) and fibrosis improvement by ≥1 stage without worsening NASH in 29.5% versus 17.5% (OR = 1.88, 95% CI = 0.7 to 5.0), respectively.","['patients with nonalcoholic steatohepatitis', '247 patients with NASH (n\u2009=\u2009101, n\u2009=\u200998 and n\u2009=\u200948 in the']","['Nonalcoholic steatohepatitis (NASH', 'ALT', 'Aramchol, a partial inhibitor of hepatic stearoyl-CoA desaturase (SCD1', 'Aramchol', 'Aramchol 400\u2009mg, 600\u2009mg and placebo', 'placebo']","['fibrosis improvement by ≥1 stage without worsening NASH', 'NASH resolution without worsening fibrosis', 'safe, well tolerated and without imbalance in serious or severe AEs', 'liver fat', 'liver triglycerides', 'hepatic triglycerides', 'liver histology and alanine aminotransferase (ALT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C1122583', 'cui_str': 'aramchol'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0038233', 'cui_str': 'Acyl-CoA desaturase'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",247.0,0.523144,"NASH resolution without worsening fibrosis was achieved in 16.7% (13 out of 78) of Aramchol 600 mg versus 5% (2 out of 40) of the placebo arm (odds ratio (OR) = 4.74, 95% CI = 0.99 to 22.7) and fibrosis improvement by ≥1 stage without worsening NASH in 29.5% versus 17.5% (OR = 1.88, 95% CI = 0.7 to 5.0), respectively.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': 'Sorbonne Université, Institute for Cardiometabolism and Nutrition and Hôpital Pitié- Salpêtrière, INSERM UMRS 1138 CRC, Paris, France. vlad.ratziu@inserm.fr.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'de Guevara', 'Affiliation': 'Hospital Ángeles Clínica Londres, Mexico City, Mexico.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Safadi', 'Affiliation': 'Hadassah Medical Organization, Hadassah Hebrew University Medical Center, Jerusalem. The Holy Family Hospital, Nazareth, Israel.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Poordad', 'Affiliation': 'Texas Liver Institute/UT Health San Antonio San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fuster', 'Affiliation': 'Centro de Investigaciones Clinicas Viña del Mar, Viña del Mar, Chile.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Flores-Figueroa', 'Affiliation': 'JM Research, Cuernavaca, Mexico.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arrese', 'Affiliation': 'Departamento de Gastroenterología Facultad de Medicina Pontificia Universidad Católica de Chile Santiago Chile and Centro de Envejecimiento y Regeneración, Facultad de Ciencias Biológicas, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Fracanzani', 'Affiliation': ""Department of Internal Medicine, Ca' Granda IRCCS Foundation, Policlinico Maggiore Hospital, University of Milan, Milan, Italy.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ben Bashat', 'Affiliation': 'Sagol Brain Institute, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine & Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lackner', 'Affiliation': 'Institute of Pathology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gorfine', 'Affiliation': 'Galmed Pharmaceuticals Ltd, Tel-Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kadosh', 'Affiliation': 'Statexcellence Ltd, Tel-Aviv, Israel.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Oren', 'Affiliation': 'Galmed Pharmaceuticals Ltd, Tel-Aviv, Israel.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Halperin', 'Affiliation': 'Galmed Pharmaceuticals Ltd, Tel-Aviv, Israel.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hayardeny', 'Affiliation': 'Galmed Pharmaceuticals Ltd, Tel-Aviv, Israel.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, University of California at San Diego, La Jolla, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Friedman', 'Affiliation': 'Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Department of Gastroenterology, Virginia Commonwealth University, Richmond, VA, USA.'}]",Nature medicine,['10.1038/s41591-021-01495-3']
1804,34587568,Cognitive behavioral intervention for improving emotion recognition among individuals with substance use disorders: A randomized-controlled pilot study in a naturalistic setting.,"Individuals with substance use disorders (SUD) experience impaired facial emotion recognition. This pilot study explored the efficacy of a cognitive behavioral therapy (CBT) intervention to improve facial cues interpretation. Twenty-four men with SUD were randomized into an equal-size experimental and control groups and were evaluated by a cognitive-assessment battery at baseline and post-intervention. Post-intervention individuals in the experimental group recognized happy expressions with higher accuracy, and their response times were slower in sadness/disgust/neutral expressions. Interventions focused at improving social cues interpretation may facilitate social interactions and treatment outcomes for SUD population.",2021,"Post-intervention individuals in the experimental group recognized happy expressions with higher accuracy, and their response times were slower in sadness/disgust/neutral expressions.","['Individuals with substance use disorders (SUD) experience impaired facial emotion recognition', 'Twenty-four men with SUD', 'individuals with substance use disorders', 'SUD population']","['Cognitive behavioral intervention', 'cognitive behavioral therapy (CBT) intervention']","['emotion recognition', 'facial cues interpretation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}]",24.0,0.0192824,"Post-intervention individuals in the experimental group recognized happy expressions with higher accuracy, and their response times were slower in sadness/disgust/neutral expressions.","[{'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Lawental', 'Affiliation': 'School of Social Work, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'School of Social Work, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Blay', 'Affiliation': 'Child and Adolescent Division, Geha Mental Health Center, P.O. Box 102, Petah Tikva 49 100, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Shoval', 'Affiliation': 'Child and Adolescent Division, Geha Mental Health Center, P.O. Box 102, Petah Tikva 49 100, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Aviv, Israel; Princeton Neuroscience Institute, Princeton University, NJ, USA. Electronic address: shovgal@tau.ac.il.'}]",Psychiatry research,['10.1016/j.psychres.2021.114220']
1805,34587567,"Cerebellar theta burst stimulation for the treatment of negative symptoms of schizophrenia: A multicenter, double-blind, randomized controlled trial.","Given the importance of the cerebellum in the pathophysiology of schizophrenia, the cerebellar vermis has been proposed as a new rTMS stimulation site for negative symptoms. In this study, 64 patients from 7 psychiatric hospitals were randomized into the study (n=32) or control (n=32) group. Intermittent theta burst stimulation (iTBS) (or sham stimulation) to the cerebellar midline was administered 5 times/week for 2 weeks. Psychotic symptoms were assessed with the Positive and Negative Symptoms Scale (PANSS) at baseline, the end of treatment, and 2, 6, 12, and 24 weeks after the treatment. Regarding the negative symptoms, the interaction effect between group and time was statistically significant, with the scores in the study group significantly lower than those in the control group at the 4 follow-ups after treatment, and the group difference was maximal at 24 weeks of follow-up. The main effect of time was significant; however, the main effect of group did not show statistical significance. Our study revealed that cerebellar iTBS may improve negative symptoms in schizophrenia patients, and the effect was more pronounced at 24 weeks after the end of treatment, which provides preliminary empirical evidence for the maintenance of efficacy after stimulation of this new site.",2021,"Regarding the negative symptoms, the interaction effect between group and time was statistically significant, with the scores in the study group significantly lower than those in the control group at the 4 follow-ups after treatment, and the group difference was maximal at 24 weeks of follow-up.","['schizophrenia patients', '64 patients from 7 psychiatric hospitals were randomized into the study (n=32) or control (n=32) group', 'negative symptoms of schizophrenia']","['Intermittent theta burst stimulation (iTBS) (or sham stimulation', 'Cerebellar theta burst stimulation']","['negative symptoms', 'Positive and Negative Symptoms Scale (PANSS', 'Psychotic symptoms']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}]",64.0,0.0893103,"Regarding the negative symptoms, the interaction effect between group and time was statistically significant, with the scores in the study group significantly lower than those in the control group at the 4 follow-ups after treatment, and the group difference was maximal at 24 weeks of follow-up.","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Weibo', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Youwei', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Mu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Tongji Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China. Electronic address: caijun533@163.com.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xie', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China. Electronic address: xiebin313@126.com.'}]",Psychiatry research,['10.1016/j.psychres.2021.114204']
1806,34587510,Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial).,"BACKGROUND


The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials.
METHODS


The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm 2  based on multi-detector computed tomography, and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding and Edwards SAPIEN 3/3 Ultra balloon-expandable devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction at 12 months which includes hemodynamic structural valve dysfunction, defined as a mean gradient ≥20 mmHg, non-structural valve dysfunction, defined as severe prothesis-patient mismatch or ≥moderate aortic regurgitation, thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically.
CONCLUSIONS


The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women.
CLINICAL TRIAL REGISTRATION


URL: www.clinicaltrials.gov, Unique identifier: NCT04722250.",2021,"The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months.","['Patients with small aortic valve annuli are typically female', 'approximately 700 subjects at approximately 90 sites globally', 'Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm 2  based on multi-detector computed tomography (MDCT), and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding (SE) and Edwards SAPIEN 3/3 Ultra balloon-expandable (BE) devices', 'patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR']",['transcatheter aortic valve replacement (TAVR) devices'],"['hemodynamic structural valve dysfunction (HSVD), defined as a mean gradient ≥20 mmHg, non-structural valve dysfunction (NSVD), defined as severe prothesis-patient mismatch (PPM) or ≥moderate aortic regurgitation (AR), thrombosis, endocarditis, and aortic valve re-intervention', 'bioprosthetic valve dysfunction (BVD', 'mortality, disabling stroke or heart failure rehospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179130', 'cui_str': 'Multidetector-Row Computed Tomography'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0014118', 'cui_str': 'Endocarditis'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",,0.239296,"The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months.","[{'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Herrmann', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA. Electronic address: Howard.herrmann@pennmedicine.upenn.edu.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Guilherme F', 'Initials': 'GF', 'LastName': 'Attizzani', 'Affiliation': 'University Hospitals of Cleveland, Cleveland, OH.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Batchelor', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bleiziffer', 'Affiliation': 'Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Verdoliva', 'Affiliation': 'Medtronic, Mounds View, MN.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Medtronic, Mounds View, MN.'}, {'ForeName': 'Hemal', 'Initials': 'H', 'LastName': 'Gada', 'Affiliation': 'UPMC Harrisburg, Harrisburg, PA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gillam', 'Affiliation': 'Morristown Medical Center/Atlantic Health System, Morristown, NJ.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Guerrero', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Mahoney', 'Affiliation': 'Sentara Healthcare, Norfolk, VA.'}, {'ForeName': 'Anna Sonia', 'Initials': 'AS', 'LastName': 'Petronio', 'Affiliation': 'Università di Pisa, Ospedale di Cisanello Pisa, Italy.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Rogers', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC; National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rovin', 'Affiliation': 'BayCare Health System/Morton Plant Hospital, Clearwater, FL.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Szerlip', 'Affiliation': 'Baylor Scott and White Heart Hospital, Plano, TX.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Whisenant', 'Affiliation': 'Intermountain Medical Center, Murray, UT.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Mount Sinai School of Medicine, New York, NY.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Clinique Pasteur, Toulouse, France.'}]",American heart journal,['10.1016/j.ahj.2021.09.011']
1807,34597872,Raising doubt about the anticipated consequences of suicidal behavior: Evidence for a new approach from laboratory and real-world experiments.,"OBJECTIVE


Converging evidence from basic science and experimental suicide research suggest that the anticipated consequences of suicide may have direct causal effects on suicidal behavior and accordingly represent a promising intervention target. Raising doubt about individuals' desirable anticipated consequences of suicide may be one means of disrupting this target. We tested this possibility across two complementary experimental studies.
METHOD


Study 1 tested the effects of raising doubt about desirable anticipated consequences on virtual reality (VR) suicide in the lab, randomizing 413 participants across four conditions. In Study 2, 226 suicidal adults were randomized to an anticipated consequence manipulation or control condition then re-assessed at 2- and 8-weeks post-baseline.
RESULTS


In Study 1, anticipating that engaging in VR suicide would guarantee a desirable outcome significantly increased the VR suicide rate; conversely, raising doubt about the desirable anticipated consequences significantly reduced the VR suicide rate. In Study 2, raising doubt about the anticipated consequences of attempting suicide by firearm significantly reduced the perceived lethality of firearms as well as self-predicted likelihood of future suicide attempts, with effects sustained at 2-week follow-up.
CONCLUSIONS


Findings suggest that raising doubt about desirable anticipated consequences of suicide merits further research as one potential approach to inhibit suicidal behavior.",2021,"In Study 2, raising doubt about the anticipated consequences of attempting suicide by firearm significantly reduced the perceived lethality of firearms as well as self-predicted likelihood of future suicide attempts, with effects sustained at 2-week follow-up.
","['413 participants across four conditions', '226 suicidal adults']",['anticipated consequence manipulation or control condition then re-assessed at 2- and 8-weeks post-baseline'],"['VR suicide rate', 'virtual reality (VR) suicide']","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]",413.0,0.0387814,"In Study 2, raising doubt about the anticipated consequences of attempting suicide by firearm significantly reduced the perceived lethality of firearms as well as self-predicted likelihood of future suicide attempts, with effects sustained at 2-week follow-up.
","[{'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Psychology, Florida State University, USA. Electronic address: ribeiro@psy.fsu.edu.'}, {'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Linthicum', 'Affiliation': 'Department of Psychology, Florida State University, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Harris', 'Affiliation': 'Department of Psychology, Florida State University, USA.'}, {'ForeName': 'Chloe P', 'Initials': 'CP', 'LastName': 'Bryen', 'Affiliation': 'Department of Psychology, Florida State University, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Broshek', 'Affiliation': 'Department of Psychology, Florida State University, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103971']
1808,34597865,Acute effects of a neuromuscular warm-up on potential re-injury risk factors associated with unanticipated jump landings after anterior cruciate ligament reconstruction: A crossover trial.,"OBJECTIVE


To investigate acute effects of a single bout of football specific neuromuscular injury preventive warm-up on potential anterior cruciate ligament (ACL) re-injury risk factors during anticipated and unanticipated jump-landings.
DESIGN


Crossover.
METHODS


Fourteen participants (mean ± SD age, 23.4 ± 4.1 years) 6-24 months after ACL reconstruction performed the Prevent Injury and Enhance Performance (PEP) and bicycle ergometer warm-up in a randomised sequence. Washout phase was one week. Countermovement jumps with anticipated and unanticipated single-leg-landings were assessed. Decision-making quality was measured using landing error count.
RESULTS


No carry-over effects occurred (p > 0.05). The unanticipated task produced significantly higher peak ground reaction forces (Δ+4%, F (11)  = 3.46, p < 0.001, eta 2  = 0.21) after PEP warm-up compared to ergometer warm-up. A lower number of decision (Δ+12%, F  (5)  = 17.1, p < 0.001, eta 2  = 0.57) and cumulated (Δ+15%, F  (3)  = 17.2, p < 0.001, eta 2  = 0.57) errors were recorded during the unanticipated condition following PEP compared to ergometer warm-up.
CONCLUSIONS


Evaluating unanticipated jump-landing ability prior to return to sports clearance may provide information on potential re-injury risk factors. PEP warm-up may be superior to bicycle ergometer warm-up at improving unanticipated decision-making quality among athletes cleared to return to sports.",2021,"A lower number of decision (Δ+12%, F  (5)  = 17.1, p < 0.001, eta 2  = 0.57) and cumulated (Δ+15%, F  (3)  = 17.2, p < 0.001, eta 2  = 0.57) errors were recorded during the unanticipated condition following PEP compared to ergometer warm-up.
","['Fourteen participants (mean\xa0±\xa0SD age, 23.4\xa0±\xa04.1 years', 'anterior cruciate ligament reconstruction']","['football specific neuromuscular injury preventive warm-up', 'neuromuscular warm-up']","['potential anterior cruciate ligament (ACL) re-injury risk factors', 'Decision-making quality', 'peak ground reaction forces', 'Prevent Injury and Enhance Performance (PEP) and bicycle ergometer', 'number of decision']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0582456', 'cui_str': 'At risk for injury'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",14.0,0.091318,"A lower number of decision (Δ+12%, F  (5)  = 17.1, p < 0.001, eta 2  = 0.57) and cumulated (Δ+15%, F  (3)  = 17.2, p < 0.001, eta 2  = 0.57) errors were recorded during the unanticipated condition following PEP compared to ergometer warm-up.
","[{'ForeName': 'Evans Y K', 'Initials': 'EYK', 'LastName': 'Ashigbi', 'Affiliation': 'Division of Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Goethe University, Frankfurt/Main, Germany; Department of Physiotherapy and Rehabilitation Sciences, School of Allied Health Sciences, University of Health and Allied Sciences, Ghana. Electronic address: ekyayra@uhas.edu.gh.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Giesche', 'Affiliation': 'Division of Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Groneberg', 'Affiliation': 'Division of Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Division of Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Niederer', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University Frankfurt/Main, Germany.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.09.010']
1809,34597743,Social reward from giving food to others affects food craving and brain potentials: An imagery-based event-related potential study.,"The interactions between social and eating behaviors can be quite pronounced and are mediated by overlapping neural circuits. The present event-related potential study tested whether the imagery of a specific prosocial behavior (giving chocolates to grateful children) can influence food cue reactivity. A total of 92 females (mean age = 23.5 years) were randomly assigned to one of three guided imagery conditions. The participants listened to an audio recording and were instructed to imagine one of three possible scenes; giving 30 M&Ms to children, eating 30 M&Ms, or sorting 30 marbles. Directly after the imagery task, the participants were presented with images of M&Ms and marbles while their electroencephalogram was recorded. We examined the Late Positive Potential (LPP) across a fronto-central and a parieto-occipital cluster, M&M craving, and subsequent consumption of (real) M&Ms. The mental imagery of offering M&Ms to children was associated with lower M&M craving and higher fronto-central LPP amplitudes (300-600 ms after picture onset) compared to the other imagery conditions. The consumption of M&Ms did not differ between the groups. The LPP is sensitive to the implementation of craving regulation strategies. Furthermore, heightened LPPs are reliably observed in response to motivationally significant stimuli, conflict, and social context. Future studies are needed to specify the specific psychological processes that are associated with the observed LPP effect. In conclusion, this study demonstrated that mental imagery of receiving a social reward from giving food to others can change components of food cue reactivity in healthy females.",2021,The mental imagery of offering M&Ms to children was associated with lower M&M craving and higher fronto-central LPP amplitudes (300-600 ms after picture onset) compared to the other imagery conditions.,"['healthy females', '92 females (mean age\u202f=\u202f23.5 years']","['participants listened to an audio recording and were instructed to imagine one of three possible scenes; giving 30\u202fM&Ms to children, eating 30\u202fM&Ms, or sorting 30 marbles']","['Late Positive Potential (LPP', 'consumption of M&Ms', 'lower M&M craving and higher fronto-central LPP amplitudes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205689', 'cui_str': 'Marble'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",,0.0493514,The mental imagery of offering M&Ms to children was associated with lower M&M craving and higher fronto-central LPP amplitudes (300-600 ms after picture onset) compared to the other imagery conditions.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Institute of Psychology, University of Graz, BioTechMed, Graz, Austria. Electronic address: anne.schienle@uni-graz.at.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gremsl', 'Affiliation': 'Institute of Psychology, University of Graz, BioTechMed, Graz, Austria.'}, {'ForeName': 'Saša', 'Initials': 'S', 'LastName': 'Zorjan', 'Affiliation': 'Institute of Psychology, University of Graz, BioTechMed, Graz, Austria; Department of Psychology, Faculty of Arts, University of Maribor, Slovenia.'}]",Appetite,['10.1016/j.appet.2021.105722']
1810,34600264,"A randomized, double-blind, placebo-controlled trial of ondansetron for the treatment of cocaine use disorder with post hoc pharmacogenetic analysis.","BACKGROUND


Cocaine use disorder (CUD) has significant consequences and there remain no FDA-approved pharmacotherapies. Ondansetron is an indirect dopaminergic modulator that has shown efficacy in alcohol use disorder, particularly in phenotypic and genotypic subgroups, and was found to be efficacious in a pilot dose-finding trial for CUD.
METHODS


One-hundred eight (108) adults with CUD were randomized to ondansetron 4 mg twice daily or placebo for 9 weeks and assessed up to thrice weekly to evaluate self-reported cocaine use and urine benzoylecgonine. Participants received cognitive-behavioral therapy and brief behavioral compliance enhancement therapy. Consenting participants (N = 79) provided blood samples for exploratory pharmacogenetic analyses.
RESULTS


Participants in both arms reduced cocaine use over time, but there was no statistically significant difference on percentage of cocaine-free days (PCFD; p = 0.972) or percentage of cocaine-free urine samples (PCFU; p = 0.909). Participants with early-onset CUD had greater improvement regardless of study arm (p = 0.002). Post hoc pharmacogenetic analyses demonstrated an interaction effect between treatment and rs1176713 SNP on PCFU in the total sample (p = 0.040) and African ancestry subset (p = 0.03). Constipation, fatigue, and somnolence were more common among ondansetron-treated participants (Fisher exact p < 0.05). Those who developed constipation were mostly rs1176713:GG carriers (Fisher exact p = 0.029).
CONCLUSIONS


Ondansetron did not demonstrate efficacy in the treatment of CUD. However, these preliminary results suggest a genotype-based variance in response to ondansetron in African ancestry individuals with CUD. Further studies are needed to validate findings for developing a personalized genomic approach for CUD treatment in racially and ethnically diverse populations.",2021,"Those who developed constipation were mostly rs1176713:GG carriers (Fisher exact p = 0.029).
","['African ancestry individuals with CUD', 'Consenting participants (N\xa0=\xa079) provided blood samples for exploratory pharmacogenetic analyses', 'One-hundred eight (108) adults with CUD']","['cocaine use and urine benzoylecgonine', 'Ondansetron', 'ondansetron', 'cognitive-behavioral therapy and brief behavioral compliance enhancement therapy', 'placebo', 'ondansetron 4\xa0mg twice daily or placebo']","['Constipation, fatigue, and somnolence']","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4084975', 'cui_str': 'Pharmacogenetic Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0053258', 'cui_str': 'Benzoylecgonine'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1123367', 'cui_str': 'Ondansetron 4 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",108.0,0.309072,"Those who developed constipation were mostly rs1176713:GG carriers (Fisher exact p = 0.029).
","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Blevins', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center/New York State Psychiatric Institute, New York, NY, United States. Electronic address: derek.blevins@nyspi.columbia.edu.'}, {'ForeName': 'Chamindi', 'Initials': 'C', 'LastName': 'Seneviratne', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD 21201, United States.'}, {'ForeName': 'Xin-Qun', 'Initials': 'XQ', 'LastName': 'Wang', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Bankole A', 'Initials': 'BA', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychiatry & Neurobehavioral Sciences, University of Virginia, Charlottesville, VA, United States (Former affiliation).'}, {'ForeName': 'Nassima', 'Initials': 'N', 'LastName': 'Ait-Daoud', 'Affiliation': 'Department of Psychiatry & Neurobehavioral Sciences, University of Virginia, Charlottesville, VA, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109074']
1811,34600262,Drug and alcohol dependence acute effects of pod-style e-cigarettes in vaping-naïve smokers.,"BACKGROUND


This study investigated the acute effects of exposure to pod-style e-cigarettes on subjective, behavioral, and physiological outcomes indicative of the potential to encourage vaping-naïve smokers to switch to e-cigarettes.
METHODS


In a within-subject experiment, never-vaping adult smokers interested in trying e-cigarettes (n = 24) completed 4 laboratory visits following 16-hr tobacco abstinence. Visits involved controlled puffing from preferred brand cigarettes (OwnCig) or a standardized pod-style e-cigarette with either no nicotine (NoNic), nicotine freebase (NicFreebase; 0.5% nicotine concentration), or nicotine salt (NicSalt E-Cig; 2.8% concentration) solutions. Outcomes included smoking urge, mood, user experience, plasma nicotine, and a behavioral task assessing ability to delay smoking.
RESULTS


NoNic, NicFreebase, and NicSalt pod-style e-cigarettes were significantly less effective than OwnCig at reducing smoking urge and increasing plasma nicotine, positive affect, satisfying user experience ratings, and ability to delay smoking on the behavioral task. Differences among pod-style e-cigarette conditions were limited to: (a) NicFreebase (vs. NoNic) preferentially suppressed participants' urge to smoke to alleviate negative mood, (b) NicFreebase (vs. NicSalt) slightly preferentially increased plasma nicotine; and (c) NicFreebase and NicSalt (vs. NoNic) produced higher aversive user experience ratings.
CONCLUSIONS


In tobacco deprived smokers' initial vaping experience, controlled administration of certain pod-style e-cigarettes with 0.5% NicFreebase or 2.8% NicSalt may be deficient comparators to cigarettes in terms of their capacity to acutely improve mood, deliver nicotine, suppress smoking motivation, and offer a satisfying user experience. Future research is needed to test pod-style e-cigarettes with higher nicotine doses and confirm whether NicFreebase vs. NicSalt enhances nicotine absorption.",2021,"were significantly less effective than OwnCig at reducing smoking urge and increasing plasma nicotine, positive affect, satisfying user experience ratings, and ability to delay smoking on the behavioral task.",['vaping-naïve smokers'],"['pod-style e-cigarettes', 'Visits involved controlled puffing from preferred brand cigarettes (OwnCig) or a standardized pod-style e-cigarette with either no nicotine (NoNic), nicotine freebase (NicFreebase; 0.5% nicotine concentration), or nicotine salt (NicSalt E-Cig; 2.8% concentration) solutions']","['smoking urge, mood, user experience, plasma nicotine, and a behavioral task assessing ability to delay smoking', 'smoking urge and increasing plasma nicotine, positive affect, satisfying user experience ratings, and ability to delay smoking on the behavioral task', 'NoNic, NicFreebase, and NicSalt pod-style e-cigarettes', 'plasma nicotine; and (c) NicFreebase and NicSalt (vs. NoNic']","[{'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}]",24.0,0.0841268,"were significantly less effective than OwnCig at reducing smoking urge and increasing plasma nicotine, positive affect, satisfying user experience ratings, and ability to delay smoking on the behavioral task.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Peraza', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Mariel S', 'Initials': 'MS', 'LastName': 'Bello', 'Affiliation': 'Department of Psychology, University of Southern California, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Schiff', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Junhan', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Callahan', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Alayna', 'Initials': 'A', 'LastName': 'Tackett', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Leventhal', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA; Department of Psychology, University of Southern California, Los Angeles, CA 90089, USA; Institute for Addiction Science, University of Southern California, Los Angeles, CA 90033, USA. Electronic address: adam.leventhal@usc.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109083']
1812,34600253,"Associations between fentanyl use and initiation, persistence, and retention on medications for opioid use disorder among people living with uncontrolled HIV disease.","BACKGROUND


Associations between fentanyl use and initiation and retention on medications for opioid use disorder (MOUD) are poorly understood.
METHODS


Data were from a multisite clinical trial comparing extended-release naltrexone (XR-NTX) with treatment as usual (TAU; buprenorphine or methadone) to achieve HIV viral suppression among people with OUD and uncontrolled HIV disease. The exposure of interest was fentanyl use, as measured by urine drug screening. Outcomes were time to MOUD initiation, defined as date of first injection of XR-NTX, buprenorphine prescription, or methadone administration; MOUD persistence, the total number of injections, prescriptions, or administrations received over 24 weeks; and MOUD retention, having an injection, prescription, or administration during weeks 20-24.
RESULTS


Participants (N = 111) averaged 47 years old and 62% were male. Just over half (57%) were Black and 13% were Hispanic. Sixty-four percent of participants tested positive for fentanyl at baseline. Participants with baseline fentanyl positivity were 11 times less likely to initiate XR-NTX than those negative for fentanyl (aHR = 0.09, 95% CI 0.03-0.24, p < .001), but there was no evidence that fentanyl use impacted the likelihood of TAU initiation (aHR = 1.50, 0.67-3.36, p = .323). Baseline fentanyl use was not associated with persistence or retention on any MOUD.
CONCLUSIONS


Fentanyl use was a substantial barrier to XR-NTX initiation for the treatment of OUD in persons with uncontrolled HIV infection. There was no evidence that fentanyl use impacted partial/full agonist initiation and, once initiated, retention on any MOUD.",2021,"Participants with baseline fentanyl positivity were 11 times less likely to initiate XR-NTX than those negative for fentanyl (aHR = 0.09, 95% CI 0.03-0.24, p < .001), but there was no evidence that fentanyl use impacted the likelihood of TAU initiation (aHR = 1.50, 0.67-3.36, p = .323).","['people with OUD and uncontrolled HIV disease', 'people living with uncontrolled HIV disease', 'persons with uncontrolled HIV infection', 'Participants (N\xa0=\xa0111) averaged 47 years old and 62% were male']",['naltrexone (XR-NTX) with treatment as usual (TAU; buprenorphine or methadone'],"['persistence or retention on any MOUD', 'time to MOUD initiation, defined as date of first injection of XR-NTX, buprenorphine prescription, or methadone administration; MOUD persistence, the total number of injections, prescriptions, or administrations received over 24 weeks; and MOUD retention, having an injection, prescription, or administration', 'likelihood of TAU initiation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",111.0,0.168866,"Participants with baseline fentanyl positivity were 11 times less likely to initiate XR-NTX than those negative for fentanyl (aHR = 0.09, 95% CI 0.03-0.24, p < .001), but there was no evidence that fentanyl use impacted the likelihood of TAU initiation (aHR = 1.50, 0.67-3.36, p = .323).","[{'ForeName': 'Ryan R', 'Initials': 'RR', 'LastName': 'Cook', 'Affiliation': 'Oregon Health & Science University, Addiction Medicine Program, Portland, OR, United States. Electronic address: cookry@ohsu.edu.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Torralva', 'Affiliation': 'CODA Treatment Program, Portland, OR, United States; Oregon Health & Science University, Department of Psychiatry, Portland, OR, United States.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'Oregon Health & Science University, Addiction Medicine Program, Portland, OR, United States.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Lum', 'Affiliation': 'Division of HIV, ID & Global Medicine, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Hansel', 'Initials': 'H', 'LastName': 'Tookes', 'Affiliation': 'Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Canyon', 'Initials': 'C', 'LastName': 'Foot', 'Affiliation': 'Oregon Health & Science University, Addiction Medicine Program, Portland, OR, United States.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Vergara-Rodriguez', 'Affiliation': 'Ruth M Rothstein CORE Center, Department of Psychiatry, Cook County Health, Chicago, IL, United States.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fanucchi', 'Affiliation': 'Division of Infectious Diseases and Center on Drug and Alcohol Research, University of Kentucky, Lexington, KY, United States.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Lucas', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Elizabeth N', 'Initials': 'EN', 'LastName': 'Waddell', 'Affiliation': 'Oregon Health & Science University, Addiction Medicine Program, Portland, OR, United States; Johns Hopkins School of Medicine, Baltimore, MD, United States; Oregon Health & Science University-Portland State University, School of Public Health, Portland, OR, United States.'}, {'ForeName': 'P Todd', 'Initials': 'PT', 'LastName': 'Korthuis', 'Affiliation': 'Oregon Health & Science University, Addiction Medicine Program, Portland, OR, United States; Johns Hopkins School of Medicine, Baltimore, MD, United States; Oregon Health & Science University-Portland State University, School of Public Health, Portland, OR, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109077']
1813,34601619,"High dose coupled plasma filtration and adsorption in septic shock patients. Results of the COMPACT-2: a multicentre, adaptive, randomised clinical trial.","PURPOSE


This study aimed at evaluating the efficacy and safety of high-dose (> 0.2 L/kg of treated plasma per day) coupled plasma filtration-adsorption (CPFA) in treating patients with septic shock.
METHODS


Multicentre, randomised, adaptive trial, performed in 12 Italian intensive care units (ICUs). Patients aged 14 or more, admitted to the ICU with septic shock, or had developed it during the stay were eligible. The final outcome was mortality at discharge from the last hospital at which the patient received care.
RESULTS


Between May 2015, and October 2017, 115 patients were randomised. The first interim analysis revealed a number of early deaths, prompting an unplanned analysis. Last hospital mortality was non-significantly higher in the CPFA (55.6%) than in the control group (46.2%, p = 0.35). The 90-day survival curves diverged in favour of the controls early after randomisation and remained separated afterwards (p = 0.100). An unplanned analysis showed higher mortality in CPFA compared to controls among patients without severe renal failure (p = 0.025); a dose-response relationship was observed between treated plasma volume and mortality (p = 0.010).
CONCLUSION


The COMPACT-2 trial was stopped due to the possible harmful effect of CPFA in patients with septic shock. The harmful effect, if present, was particularly marked in the early phase of septic shock. Patients not requiring renal replacement therapy seemed most exposed to the possible harm, with evidence of a dose-response effect. Until the mechanisms behind these results are fully understood, the use of CPFA for the treatment of patients with septic shock is not recommended.",2021,"Last hospital mortality was non-significantly higher in the CPFA (55.6%) than in the control group (46.2%, p = 0.35).","['septic shock patients', 'Between May 2015, and October 2017, 115 patients were randomised', '12 Italian intensive care units (ICUs', 'Patients aged 14 or more, admitted to the ICU with septic shock, or had developed it during the stay were eligible', 'patients with septic shock']","['CPFA', 'high-dose (>\u20090.2 L/kg of treated plasma per day) coupled plasma filtration-adsorption (CPFA']","['mortality in CPFA', 'Last hospital mortality', 'efficacy and safety', 'number of early deaths', '90-day survival curves']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0398340', 'cui_str': 'Plasma filtration'}, {'cui': 'C0001674', 'cui_str': 'Adsorption'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1637390', 'cui_str': 'mL/g'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0398340', 'cui_str': 'Plasma filtration'}, {'cui': 'C0001674', 'cui_str': 'Adsorption'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",115.0,0.100423,"Last hospital mortality was non-significantly higher in the CPFA (55.6%) than in the control group (46.2%, p = 0.35).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Garbero', 'Affiliation': 'Laboratorio di Epidemiologia Clinica, Istituto di Ricerche Farmacologiche Mario Negri IRCCS: Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò, 24020, Ranica, BG, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Livigni', 'Affiliation': 'SC Anestesia Rianimazione Ospedale San Giovanni Bosco, ASL Città Di Torino, Torino, Italy.'}, {'ForeName': 'Fiorenza', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'Department of Anaesthesia and Intensive Care Unit, I.R.C.C.S. San Matteo Hospital and University of Pavia, Pavia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Finazzi', 'Affiliation': 'Laboratorio di Epidemiologia Clinica, Istituto di Ricerche Farmacologiche Mario Negri IRCCS: Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò, 24020, Ranica, BG, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Langer', 'Affiliation': 'Emergency NGO, Milano, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Malacarne', 'Affiliation': 'U.O. Anestesia e Rianimazione 6, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Manlio Cosimo Claudio', 'Initials': 'MCC', 'LastName': 'Meca', 'Affiliation': 'Dipartimento Grandi Traumi, Unità Operativa di Anestesia e Rianimazione, Ospedale Maurizio Bufalini di Cesena, Cesena, Italy.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'Mosca', 'Affiliation': 'SC Anestesia Rianimazione Ospedale San Giovanni Bosco, ASL Città Di Torino, Torino, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Olivieri', 'Affiliation': ""Ospedale Sant'Andrea, Anesthesia and Intensive Care, Vercelli, VC, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pozzato', 'Affiliation': 'Struttura Complessa Universitaria di Nefrologia e Dialisi-CMID, Ospedale San Giovanni Bosco, ASL Città Di Torino, Torino, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Rossi', 'Affiliation': 'Laboratorio di Epidemiologia Clinica, Istituto di Ricerche Farmacologiche Mario Negri IRCCS: Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò, 24020, Ranica, BG, Italy. carlotta.rossi@marionegri.it.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Tavola', 'Affiliation': 'SC Anestesia E Rianimazione, ASST-Lecco, Lecco, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Terzitta', 'Affiliation': 'Department of Anesthesia and Intensive Care, Morgagni-Pierantoni Hospital, Forlì, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Viaggi', 'Affiliation': 'Neuroanestesia e Rianimazione AOU Careggi, Florence, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Bertolini', 'Affiliation': 'Laboratorio di Epidemiologia Clinica, Istituto di Ricerche Farmacologiche Mario Negri IRCCS: Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò, 24020, Ranica, BG, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-021-06501-3']
1814,34601093,Smartphone based music intervention in the treatment of episodic migraine headaches - A pilot trial.,"OBJECTIVES


Migraine headaches are a prevalent and burdening disorder for the public worldwide. Both traditional preventive drugs and behavioral-based interventions have been used as treatment in the prevention of migraine attacks. However, benefits of alternative interventions in patients with primary headache disorders have not yet been fully explored. The present investigation sought to examine the impact of a patient controlled music intervention (MUSIC CARE) on episodic migraine headache.
DESIGN


A sample of 20 episodic migraine patients (17 females, mean age of 42 years) was included in the pilot trial. Patients completed a pre-treatment assessment on headache severity, associated psychopathological distress (anxiety and depression) and functional impairment, and provided reports on their medication intake. During the 3-months intervention period, patients required 1-2 music sessions (based on the ""U"" sequence) per day with a minimum of 15 per month.
RESULTS


Following the intervention, patients reported a significant reduction in the frequency of migraine attacks (M Diff  = -2.8, p = .01). Ten patients reported a 50% reduction in the frequency of migraine attacks. Additionally, there was a significant reduction in medication intake (M Diff  = -2.85, p = .02), the duration of migraine attacks (M Diff  = -5.45, p = .002), anxiety (M Diff  = -1.65 (2.88), p = .02) and depression (M Diff  = -2.45 (3.5), p = .002).
CONCLUSION


These data provide evidence that music intervention may significantly prevent migraine attacks. Moreover, this method is easily accessible and administered. Future well-controlled clinical trials are necessary to further explore the efficiency of the intervention.",2021,"Following the intervention, patients reported a significant reduction in the frequency of migraine attacks (M Diff  = -2.8, p = 0.01).","['20 episodic migraine patients (17 females, mean age of 42 years', 'patients with primary headache disorders']","['Smartphone Based Music Intervention', 'patient controlled music intervention (MUSIC CARE']","['migraine attacks', 'frequency of migraine attacks', 'anxiety', 'episodic migraine headache', 'headache severity, associated psychopathological distress (anxiety and depression) and functional impairment', 'duration of migraine attacks', 'medication intake']","[{'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1565106', 'cui_str': 'Primary Headache Disorders'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",,0.0385763,"Following the intervention, patients reported a significant reduction in the frequency of migraine attacks (M Diff  = -2.8, p = 0.01).","[{'ForeName': 'Guilhem', 'Initials': 'G', 'LastName': 'Parlongue', 'Affiliation': ""Centre d'Evaluation et Traitement de la Douleur, CHU La Réunion - GHSR, France. Electronic address: guilhem_parlongue@hotmail.com.""}, {'ForeName': 'Emmanuelle Vuillaume', 'Initials': 'EV', 'LastName': 'Cerdan', 'Affiliation': ""Centre d'Evaluation et Traitement de la Douleur, CHU La Réunion - GHSR, France.""}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Koenig', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Cologne, Germany.'}, {'ForeName': 'DeWayne P', 'Initials': 'DP', 'LastName': 'Williams', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA, USA.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102779']
1815,34608851,An ergonomic welding torch reduces physical load response and improves welding quality in novices: a pilot study.,"Objectives.  This crossover pilot study aimed to compare the physical load response of an ergonomically improved welding torch versus a conventional torch.  Methods . Ten inexperienced volunteers performed an experimental augmented virtual welding trial at chest height (ASME code 1G) and overhead (ASME code 4G) with both welding torches in random order. Skeletal muscle load and fatigue were assessed by surface electromyography and changes in isometric peak force. The sensation of pain, perceived exertion and welding execution quality were defined as further outcome parameters.  Results . The muscle load response in three out of eight muscles was lower in favour of the ergonomic welding torch, which went along with a lower sensation of pain and a higher working accuracy.  Conclusions . An ergonomically improved welding torch reduces the acute physical load response and sensation of pain, which ultimately allows performing better, and might contribute to prevention of musculoskeletal diseases in the long term.",2021,"The muscle load response in 3 out of 8 muscles was lower in favour of the ergonomic welding torch, which went along with a lower sensation of pain and a higher working accuracy.
",['10 inexperienced volunteers'],"['experimental augmented virtual welding trial at chest height (ASME code 1G) and overhead (ASME code 4G) with both welding torches', 'ergonomically improved welding torch vs. a conventional torch']","['physical load response', 'sensation of pain, perceived exertion and welding execution quality', 'Welding Quality', 'acute physical load response and sensation of pain', 'Skeletal muscle load and fatigue', 'isometric peak force']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0270173', 'cui_str': 'TORCH syndrome'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0043106', 'cui_str': 'Welding'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",10.0,0.0559222,"The muscle load response in 3 out of 8 muscles was lower in favour of the ergonomic welding torch, which went along with a lower sensation of pain and a higher working accuracy.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pilat', 'Affiliation': 'Department of Sports Therapy and Exercise Physiology, Justus-Liebig-University, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Weyh', 'Affiliation': 'Department of Sports Therapy and Exercise Physiology, Justus-Liebig-University, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'Department of Sports Therapy and Exercise Physiology, Justus-Liebig-University, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Krüger', 'Affiliation': 'Department of Sports Therapy and Exercise Physiology, Justus-Liebig-University, Germany.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Schubert', 'Affiliation': 'Abicor Binzel, Alexander Binzel Schweißtechnik GmbH & Co.KG, Germany.'}, {'ForeName': 'Frank-Christoph', 'Initials': 'FC', 'LastName': 'Mooren', 'Affiliation': 'Department of Medicine, University of Witten/Herdecke, Germany.'}]",International journal of occupational safety and ergonomics : JOSE,['10.1080/10803548.2021.1989199']
1816,34607194,Do people with opioid use disorder and posttraumatic stress disorder benefit from dding Individual opioid Drug Counseling to buprenorphine?,"BACKGROUND AND PURPOSE


Large randomized trials have found that behavioral therapy for opioid use disorder (e.g., Individual Drug Counseling, Cognitive Behavioral Therapy for Opioid Use Disorder) does not improve buprenorphine maintenance outcomes, on average, for individuals with opioid use disorder. However, recent studies indicate that certain subgroups of patients may benefit from the addition of behavioral therapy to buprenorphine. In particular, people with more complex and severe psychosocial needs may benefit from the addition of behavioral therapy for opioid use disorder.
METHODS


In this study, we conducted a secondary analysis of a large, multi-site randomized trial (N = 357) of buprenorphine maintenance with and without individual Opioid Drug Counseling (ODC) for the treatment of opioid use disorder. We hypothesized that participants with posttraumatic stress disorder (PTSD) would benefit from the addition of ODC.
RESULTS


Logistic regression models indicated a significant PTSD by treatment condition interaction. Specifically, 67% of those with PTSD had a successful opioid use disorder treatment outcome when they were assigned to receive both ODC and buprenorphine, compared to a 36% response rate among those who received buprenorphine alone.
CONCLUSIONS


Although these results require replication, our findings provide initial indication that ODC is an important complement to buprenorphine maintenance treatment for people with co-occurring PTSD and opioid use disorder.",2021,"Specifically, 67% of those with PTSD had a successful opioid use disorder treatment outcome when they were assigned to receive both ODC and buprenorphine, compared to a 36% response rate among those who received buprenorphine alone.
","['individuals with opioid use disorder', 'participants with posttraumatic stress disorder (PTSD', 'people with co-occurring PTSD and opioid use disorder']","['ODC and buprenorphine', 'buprenorphine maintenance with and without individual Opioid Drug Counseling (ODC', 'buprenorphine']",['successful opioid use disorder treatment outcome'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0405309,"Specifically, 67% of those with PTSD had a successful opioid use disorder treatment outcome when they were assigned to receive both ODC and buprenorphine, compared to a 36% response rate among those who received buprenorphine alone.
","[{'ForeName': 'R Kathryn', 'Initials': 'RK', 'LastName': 'McHugh', 'Affiliation': 'Division of Alcohol, Drugs and Addiction, McLean Hospital, USA; Department of Psychiatry, Harvard Medical School, USA. Electronic address: kmchugh@mclean.harvard.edu.'}, {'ForeName': 'Blake T', 'Initials': 'BT', 'LastName': 'Hilton', 'Affiliation': 'Division of Alcohol, Drugs and Addiction, McLean Hospital, USA; Department of Psychiatry, Harvard Medical School, USA.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Chase', 'Affiliation': 'Division of Alcohol, Drugs and Addiction, McLean Hospital, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Griffin', 'Affiliation': 'Division of Alcohol, Drugs and Addiction, McLean Hospital, USA; Department of Psychiatry, Harvard Medical School, USA.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Weiss', 'Affiliation': 'Division of Alcohol, Drugs and Addiction, McLean Hospital, USA; Department of Psychiatry, Harvard Medical School, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109084']
1817,34607175,Estradiol administration modulates neural emotion regulation.,"Variations of sex hormones during the menstrual cycle can lead to changes in emotion processing. The ability to successfully regulate one's emotions is associated with better social abilities and mental health. While women show better performance in fear extinction learning under high estradiol (E2) compared to women under low E2 levels, little is known about the effect of E2 on emotion regulation. We explored whether E2 modulates emotion regulation in a functional magnetic resonance imaging paradigm and administered E2 valerate to 32 young naturally cycling women during their early follicular phase in a double-blind, placebo-controlled within-subject design. This standardized experimental control allowed us to explore the specific effect of E2 on emotion regulation while controlling for other hormones varying throughout the menstrual cycle. Behaviorally, no difference between conditions appeared. However, on the neural level, E2 administration was associated with lower activation in the right lingual- and left calcarine gyrus, right orbitofrontal cortex and left hippocampus relative to placebo. With respect to the main effect of down-regulation higher activation of the right superior frontal gyrus and left dorsomedial prefrontal cortex was seen; which is in accordance to previous literature. An interaction between drug condition and emotion regulation appeared for the left inferior frontal gyrus extending into the middle frontal gyrus indicating lower activation during down-regulation in the E2 condition than the placebo condition. On the behavioral level, women reported less negative affect in the E2 condition. The results fit well to a previously described psychoneuroendocrinological model in which E2 plays an important modulatory role on emotional processes and risk factors of mental health in women.",2021,With respect to the main effect of down-regulation higher activation of the right superior frontal gyrus and left dorsomedial prefrontal cortex was seen; which is in accordance to previous literature.,"['women', '32 young naturally cycling women during their early follicular phase in a double-blind, placebo-controlled within-subject design']","['E2 valerate', 'Estradiol']","['neural emotion regulation', 'E2 modulates emotion regulation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Proliferative Phase'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0042280', 'cui_str': 'Pentanoates'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",32.0,0.0694975,With respect to the main effect of down-regulation higher activation of the right superior frontal gyrus and left dorsomedial prefrontal cortex was seen; which is in accordance to previous literature.,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Rehbein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Innovative Neuroimaging, Tübingen Center for Mental Health (TüCMH), University of Tübingen, Tübingen, Germany; Werner Reichardt Centre for Integrative Neuroscience, University of Tübingen, Tübingen, Germany. Electronic address: Elisa.Rehbein@med.uni-tuebingen.de.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Kogler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Innovative Neuroimaging, Tübingen Center for Mental Health (TüCMH), University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hornung', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Innovative Neuroimaging, Tübingen Center for Mental Health (TüCMH), University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Morawetz', 'Affiliation': 'Institute of Psychology, University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Bayer', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Krylova', 'Affiliation': 'Werner Reichardt Centre for Integrative Neuroscience, University of Tübingen, Tübingen, Germany; Department of Psychiatry and Psychotherapy, University of Jena, Jena, Germany; Medical Physics Group, Institute of Diagnostic and Interventional Radiology, Jena University Hospital - Friedrich Schiller University Jena, Germany.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Sundström-Poromaa', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Derntl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Innovative Neuroimaging, Tübingen Center for Mental Health (TüCMH), University of Tübingen, Tübingen, Germany; Lead Graduate School, University of Tübingen, Tübingen, Germany. Electronic address: Birgit.Derntl@med.uni-tuebingen.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105425']
1818,34607172,I only have eyes for you: Oxytocin administration supports romantic attachment formation through diminished interest in close others and strangers.,"Animal studies confirm oxytocin's (OT) role in regulating monogamous sexual behavior in pair-bonding rodents; and human studies are beginning to translate how this highly conserved neuropeptide is implicated in romantic attachment formation. A number of studies have shown how OT promotes relationship exclusivity by diminishing interest in strangers and increasing reward response to partners. Less clear is whether these effects are modulated by romantic duration or life history factors, or if OT's social distancing effects generalize beyond strangers to close relationships. We report the results of a double-blind, placebo-controlled crossover study on the effects of a single dose of intranasal OT (24 IU) on forty-four young adults (91% female) in different stages of romantic attachment formation (M duration=21 months). Participants completed a screening survey and two lab visits separated by 4-weeks, including a diagrammatic measure of attachment to parents and peers, attitudes related to sexual conservatism and partner infidelity, ratings scales of closeness to romantic partners, and visual attractiveness ratings of strangers. Individual differences were examined by life history factors, including maternal love withdrawal and parental separation. Results indicated that OT administration decreased attachment to mothers, decreased attachment to subsidiary attachment figures, and decreased attraction to strangers. In all cases, emotional distancing was stronger among participants in newer romantic relationships. OT increased arousal to partner infidelity and increased sexual conservatism among participants with negative life history experiences (parental separation and high love withdrawal), whereas the reverse was true for participants reporting a more positive life history. Findings suggest that OT supports exclusivity through social distancing from strangers and close others within a sensitive period of attachment formation. In addition, findings indicate OT plays a different role in mate retention strategies by life history.",2021,"Results indicated that OT administration decreased attachment to mothers, decreased attachment to subsidiary attachment figures, and decreased attraction to strangers.","['forty-four young adults (91% female) in different stages of romantic attachment formation (M duration=21 months', 'I only have eyes for you']","['OT', ""oxytocin's (OT"", 'intranasal OT', 'placebo', 'Oxytocin']","['diagrammatic measure of attachment to parents and peers, attitudes related to sexual conservatism and partner infidelity, ratings scales of closeness to romantic partners, and visual attractiveness ratings of strangers', 'OT increased arousal to partner infidelity and increased sexual conservatism', 'romantic attachment formation', 'emotional distancing', 'maternal love withdrawal and parental separation']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009800', 'cui_str': 'Conservatism'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0855746', 'cui_str': 'Oxytocin increased'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0036679', 'cui_str': 'Separation'}]",44.0,0.0317389,"Results indicated that OT administration decreased attachment to mothers, decreased attachment to subsidiary attachment figures, and decreased attraction to strangers.","[{'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Freeman', 'Affiliation': 'Division of Counseling and Psychology in Education & Center for Brain and Behavior Research, School of Education, University of South Dakota,\xa0414 E. Clark Street, Vermillion, SD 57069, United States. Electronic address: harry.freeman@usd.edu.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Scholl', 'Affiliation': 'Basic Biomedical Sciences & Center for Brain and Behavior Research, Sanford School of Medicine, University of South Dakota, United States.'}, {'ForeName': 'Musheera', 'Initials': 'M', 'LastName': 'AnisAbdellatif', 'Affiliation': 'Division of Counseling and Psychology in Education & Center for Brain and Behavior Research, School of Education, University of South Dakota,\xa0414 E. Clark Street, Vermillion, SD 57069, United States.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Gnimpieba', 'Affiliation': 'Biomedical Engineering, School of Arts & Sciences, University of South Dakota, United States.'}, {'ForeName': 'Gina L', 'Initials': 'GL', 'LastName': 'Forster', 'Affiliation': 'Department of Anatomy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Jacob', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Child & Adolescent Psychiatry, University of Minnesota Medical School, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105415']
1819,34628695,Effects of non-viable Lactobacillus reuteri combining with 14-day standard triple therapy on Helicobacter pylori eradication: A randomized double-blind placebo-controlled trial.,"BACKGROUND


Viable probiotics have shown effects on the eradication of Helicobacter pylori, but the role of non-viable probiotics in H. pylori eradication is unclear. This study aimed to evaluate the effects of non-viable Lactobacillus reuteri DSM17648 combining with 14-day standard triple therapy on H. pylori eradication.
MATERIALS AND METHODS


Two hundred treatment-naive H. pylori-positive adult patients were randomized equally to receive non-viable L. reuteri DSM17648 (LR group) or placebo for 4 weeks, with the latter 2 weeks treated together with triple therapy. The Gastrointestinal Symptom Rating Scale (GSRS) was completed before and after treatment. Stool samples were collected for 16S rRNA gene sequencing at week0, week2, and week8.
RESULTS


Eradication rates in the LR group and the placebo group were 81.8% and 83.7% in ITT analysis (p = 0.730), 86.2% and 87.2% in PP analysis (p = 0.830), respectively. After treatment, the mean GSRS score decreased significantly in the LR group as compared with the placebo group (1.9 ± 0.2 vs. 2.7 ± 0.3; p = 0.030). Significantly less patients in the LR group as compared with the placebo group reported abdominal distention (5.1% vs. 16.3%; p = 0.010) and diarrhea (11.1% vs. 23.5%; p = 0.022). The relative abundance of Proteobacteria phylum and Escherichia-Shigella genus in the placebo group was about 4.0-fold and 8.1-fold of that in the LR group at wk2, respectively. Significant changes of diversity and enhancements of Fusicatenibacter, Subdoligranulum, and Faecalibacterium were observed in the LR group compared with the placebo group.
CONCLUSIONS


Supplementation of non-viable L. reuteri DSM17648 with triple therapy did not improve the eradication rate of H. pylori, but it helped to build up a beneficial microbial profile and reduced the frequencies of abdominal distention, diarrhea, and the GSRS score.",2021,"CONCLUSIONS


Supplementation of non-viable L. reuteri DSM17648 with triple therapy did not improve the eradication rate of H. pylori, but it helped to build up a beneficial microbial profile and reduced the frequencies of abdominal distention, diarrhea, and the GSRS score.",['Two hundred treatment-naive H. pylori-positive adult patients'],"['placebo', 'non-viable L. reuteri DSM17648 (LR group) or placebo', 'non-viable Lactobacillus reuteri combining with 14-day standard triple therapy']","['abdominal distention', 'Helicobacter pylori eradication', 'relative abundance of Proteobacteria phylum and Escherichia-Shigella genus', 'frequencies of abdominal distention, diarrhea, and the GSRS score', 'diversity and enhancements of Fusicatenibacter, Subdoligranulum, and Faecalibacterium', 'eradication rate of H. pylori', 'mean GSRS score', 'Eradication rates', 'diarrhea', 'Gastrointestinal Symptom Rating Scale (GSRS']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C0014833', 'cui_str': 'Escherichia'}, {'cui': 'C0013371', 'cui_str': 'Infection by Shigella'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C1503440', 'cui_str': 'Subdoligranulum'}, {'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",200.0,0.4866,"CONCLUSIONS


Supplementation of non-viable L. reuteri DSM17648 with triple therapy did not improve the eradication rate of H. pylori, but it helped to build up a beneficial microbial profile and reduced the frequencies of abdominal distention, diarrhea, and the GSRS score.","[{'ForeName': 'Chenghai', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Pinjing', 'Initials': 'P', 'LastName': 'Lv', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Siqi', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhiqing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}]",Helicobacter,['10.1111/hel.12856']
1820,34628013,Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience.,"BACKGROUND


Palliative care (PC) in advanced heart failure (HF) aims to improve symptoms and quality of life (QOL), in part through medication management. The impact of PC on polypharmacy (>5 medications) remains unknown.
METHODS AND RESULTS


We explored patterns of polypharmacy in the Palliative Care in HF (PAL-HF) randomized controlled trial of standard care vs interdisciplinary PC in advanced HF (N = 150). We describe differences in medication counts between arms at 2, 6, 12, and 24 weeks for HF (12 classes) and PC (6 classes) medications. General linear mixed models were used to evaluate associations between treatment arm and polypharmacy over time. The median age of the patients was 72 years (interquartile range 62-80 years), 47% were female, and 41% were Black. Overall, 48% had ischemic etiology, and 55% had an ejection fraction of 40% or less. Polypharmacy was present at baseline in 100% of patients. HF and PC medication counts increased in both arms, with no significant differences in counts by drug class at any time point between arms.
CONCLUSIONS


In a trial of patients with advanced HF considered eligible for PC, polypharmacy was universal at baseline and increased during follow-up with no effect of the palliative intervention on medication counts relative to standard care.",2021,"HF and PC medication counts increased in both arms, with no significant differences in counts by drug class at any time-point between arms.
","['The median age of the patients was 72 (62-80) years, and 47% were female while 41% were Black', 'Advanced Heart Failure', 'We explored patterns of polypharmacy in the Palliative Care in HF (PAL-HF) randomized controlled trial of standard care versus interdisciplinary PC in advanced HF (N=150']",[],"['HF and PC medication counts', 'symptoms and quality of life (QOL', 'medication counts', 'ischemic etiology']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}]",[],"[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",,0.190934,"HF and PC medication counts increased in both arms, with no significant differences in counts by drug class at any time-point between arms.
","[{'ForeName': 'Bradi B', 'Initials': 'BB', 'LastName': 'Granger', 'Affiliation': 'School of Nursing, Duke University, Durham, North Carolina; Margolis Center for Health Policy, Duke University, Durham, North Carolina. Electronic address: bradi.granger@dm.duke.edu.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Tulsky', 'Affiliation': ""Dana-Farber Institute, Harvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Brystana G', 'Initials': 'BG', 'LastName': 'Kaufman', 'Affiliation': 'Margolis Center for Health Policy, Duke University, Durham, North Carolina; Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Clare', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Margolis Center for Health Policy, Duke University, Durham, North Carolina.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'connor"", 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Rogers', 'Affiliation': 'Texas Heart Institute, Houston, Texas.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Texas Heart Institute, Houston, Texas.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2021.08.021']
1821,34627967,Real-world experience of feasibility and efficacy of electrical muscle stimulation in elderly patients with acute heart failure: A randomized controlled study.,"BACKGROUND


Reduced aerobic capacity and deconditioning contributes to morbidity and mortality in elderly acute heart failure (AHF) patients. Electrical muscle stimulation (EMS) has shown to be a suitable alternative to exercise in AHF. However, feasibility and efficacy are unknown in a real-world setting.
METHODS


This is a prospective, open label blinded, randomized, controlled study, investigating feasibility and efficacy of high-intensity versus low-intensity EMS versus controls in elderly AHF patients. Patients and investigators were blinded to the intervention. EMS was offered to > 60 years old AHF patients, initiated during hospitalization and continued at home. Outcome measures included changes in 6-min walking test distance (6-MWTD), functional capacity and quality-of-life at 3 and 6 weeks.
RESULTS


Among 97 consecutive AHF patients (78.1 ± 9.4 years, 42.3% females), 60 (61.9%) were eligible for EMS. Of these, 27 provided written informed consent and were randomly assigned to high-intensity (n = 10), low-intensity EMS (n = 9) and controls (n = 8). 13/27 completed the intervention. Main reason for dropouts was intolerance of the overall intervention burden. MACE occurred in 5 and were not associated with the study. EMS groups showed significant improvement of 6-MWTD (controls vs low-intensity p = 0.018) and of independence in daily living (for both p < 0.05).
CONCLUSIONS


Changes in 6-MWTD suggest efficacy of EMS. Whereas all tolerated EMS well, the burden of study intervention was too high and resulted in a consent rate of <50% and high dropouts, which limit the interpretability of our data. Less demanding EMS protocols are required to evaluate the full potential of EMS in elderly AHF patients.",2021,"EMS groups showed significant improvement of 6-MWTD (controls vs low-intensity p = 0.018) and of independence in daily living (for both p < 0.05).
","['elderly acute heart failure (AHF) patients', 'elderly patients with acute heart failure', '97 consecutive AHF patients (78.1\u202f±\u202f9.4\u202fyears, 42.3% females), 60 (61.9%) were eligible for EMS', 'elderly AHF patients']","['electrical muscle stimulation', 'high-intensity versus low-intensity EMS', 'MACE', 'Electrical muscle stimulation (EMS']","['6-MWTD', 'feasibility and efficacy', 'independence in daily living', 'changes in 6-min walk distance (6-MWTD), functional capacity and quality-of-life at 3 and 6\u202fweeks']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439230', 'cui_str': 'week'}]",97.0,0.0350216,"EMS groups showed significant improvement of 6-MWTD (controls vs low-intensity p = 0.018) and of independence in daily living (for both p < 0.05).
","[{'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Arenja', 'Affiliation': 'Department of Cardiology, Kantonsspital Olten, Solothurner Spitäler AG, Olten, Switzerland. Electronic address: nisha.arenja@spital.so.ch.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB), Department of Cardiology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tomilovskaya', 'Affiliation': 'Institute for Biomedical Problems of the Russian Academy of Sciences, Moscow, Russia.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Koryak', 'Affiliation': 'Institute for Biomedical Problems of the Russian Academy of Sciences, Moscow, Russia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Poltavskaya', 'Affiliation': 'I.M. Sechenov, First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Saner', 'Affiliation': 'I.M. Sechenov, First Moscow State Medical University, Moscow, Russia; Institute for Social and Preventive Medicine and ARTORG Center for Biomedical Engineering Research, University of Bern, Bern, Switzerland.'}]",International journal of cardiology,['10.1016/j.ijcard.2021.09.062']
1822,34627875,Mechanisms of action of duodenal mucosal resurfacing in insulin resistant women with polycystic ovary syndrome.,"BACKGROUND


Duodenal mucosal resurfacing (DMR) is a novel day-case endoscopic intervention which results in weight loss-independent reductions in HbA1c in patient with type 2 diabetes mellitus (T2DM). We hypothesized that DMR works by increasing insulin sensitivity and we aimed to investigate the mechanism of action of DMR through longitudinal metabolic phenotyping in humans.
METHODS


Thirty-two insulin-resistant women with polycystic ovary syndrome (PCOS) and obesity were randomised in a double-blinded manner to DMR or sham endoscopy. They underwent measurements of insulin sensitivity using euglycaemic hyperinsulinaemic clamps, insulin secretion using oral glucose tolerance tests and reproductive function using weekly reproductive hormone profiles and ovarian ultrasonography for 6 months post-intervention.
RESULTS


A small increase in total body insulin sensitivity measured by the clamp was observed in both groups at week 12. An increase in insulin sensitivity, as measured by HOMA-IR, was observed in both groups at week 24. There was an increase in the number of menses (median 2 DMR, 0.5 sham). There were no significant differences between the two groups in these outcomes or insulin secretion.
CONCLUSIONS


These findings suggest that DMR does not work by increasing insulin sensitivity in euglycaemic, insulin resistant women with PCOS. The procedure may exert its effects only in the context of hyperglycaemia or pathologically hyperplastic, insulin-desensitised duodenal mucosa.",2021,"There were no significant differences between the two groups in these outcomes or insulin secretion.
","['patient with type 2 diabetes mellitus (T2DM', 'insulin resistant women with polycystic ovary syndrome', 'Thirty-two insulin-resistant women with polycystic ovary syndrome (PCOS) and obesity']","['DMR or sham endoscopy', 'duodenal mucosal resurfacing', 'euglycaemic hyperinsulinaemic clamps, insulin secretion', 'DMR', 'Duodenal mucosal resurfacing (DMR']","['total body insulin sensitivity', 'outcomes or insulin secretion', 'number of menses', 'HOMA-IR', 'insulin sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",32.0,0.0951545,"There were no significant differences between the two groups in these outcomes or insulin secretion.
","[{'ForeName': 'Vasha', 'Initials': 'V', 'LastName': 'Kaur', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, UK.'}, {'ForeName': 'Georgios K', 'Initials': 'GK', 'LastName': 'Dimitriadis', 'Affiliation': ""Department of Endocrinology, King's College Hospital NHS Foundation Trust, Denmark Hill, SE5 9RS, UK.""}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Pérez-Pevida', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, UK.'}, {'ForeName': 'Davinder Singh', 'Initials': 'DS', 'LastName': 'Bansi', 'Affiliation': 'Department of Gastroenterology, Imperial College Healthcare NHS Trust, UK.'}, {'ForeName': 'Channa', 'Initials': 'C', 'LastName': 'Jayasena', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Bate', 'Affiliation': 'Warwickshire Institute for Diabetes, Endocrinology & Metabolism, University Hospitals Coventry & Warwickshire, UK.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Houghton', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, UK.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Fielding', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, UK.'}, {'ForeName': 'Danai', 'Initials': 'D', 'LastName': 'Balfoussia', 'Affiliation': 'Department of Gynaecology, Imperial College Healthcare NHS Trust, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'Department of Gynaecology, Imperial College Healthcare NHS Trust, UK.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, UK.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Mears', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Coppin', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, UK.'}, {'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Biostatistics, Avania Clinical, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Biostatistics, Avania Clinical, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, UK.'}, {'ForeName': 'Anne Margot', 'Initials': 'AM', 'LastName': 'Umpleby', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, UK.'}, {'ForeName': 'Harpal S', 'Initials': 'HS', 'LastName': 'Randeva', 'Affiliation': 'Warwickshire Institute for Diabetes, Endocrinology & Metabolism, University Hospitals Coventry & Warwickshire, UK; Department of Experimental & Translational Medicine, Warwick Medical School, UK.'}, {'ForeName': 'Alexander Dimitri', 'Initials': 'AD', 'LastName': 'Miras', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, UK. Electronic address: a.miras@nhs.net.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2021.154908']
1823,34600245,Citalopram for treatment of cocaine use disorder: A Bayesian drop-the-loser randomized clinical trial.,"BACKGROUND


Medication development research for cocaine use disorder (CUD) has been a longstanding goal in addiction research, but has not resulted in an FDA-approved treatment. Rising cocaine use rates underscore the need for efficient adaptive designs. This study compared differences between two doses of the selective serotonin reuptake inhibitor (SSRI) citalopram (versus placebo) on duration of cocaine abstinence and applied adaptive decision rules to select the 'best efficacy' dose.
METHODS


A double-blind, placebo-controlled, randomized Bayesian drop-the-loser (DTL) trial with three arms compared placebo to citalopram 20 mg and 40 mg. Adults (N = 107) with CUD attended thrice-weekly clinic visits for 9 weeks. The primary outcome was longest duration of abstinence (LDA), based on continuous cocaine-negative urine drug screens (UDS). The secondary outcome was probability of cocaine-negative UDS during treatment. A planned interim analysis performed at approximately 50% of recruitment dropped the least-effective active medication. Bayesian inference was used for all analyses with a pre-specified posterior probability (PP) threshold PP ≥ 95% considered statistically reliable evidence RESULTS: Citalopram 40 mg satisfied interim efficacy criteria and was retained for the second half of the trial. For LDA, analyses indicated PP = 82% and PP = 65% of benefit for 40 mg and 20 mg, respectively (each relative to placebo). The odds of having cocaine-negative UDS decreased in all groups over 9 weeks but remained higher for 40 mg (PP = 97.4%) CONCLUSIONS: Neither dose met the 95% PP threshold for the primary outcome; however, 40 mg provided moderate-to-strong evidence for positive effects on LDA and cocaine-negative UDS. The 40 mg dose was declared the ""winner"" in this DTL trial.",2021,The odds of having cocaine-negative UDS decreased in all groups over 9 weeks but remained higher for 40 mg (PP = 97.4%),"['cocaine use disorder', 'Adults (N\xa0=\xa0107) with CUD attended thrice-weekly clinic visits for 9 weeks']","['placebo', 'placebo to citalopram', 'Citalopram', 'selective serotonin reuptake inhibitor (SSRI) citalopram (versus placebo']","['probability of cocaine-negative UDS', 'duration of cocaine abstinence', 'odds of having cocaine-negative UDS', 'longest duration of abstinence (LDA), based on continuous cocaine-negative urine drug screens (UDS']","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",107.0,0.321342,The odds of having cocaine-negative UDS decreased in all groups over 9 weeks but remained higher for 40 mg (PP = 97.4%),"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Suchting', 'Affiliation': 'Faillace Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: Robert.Suchting@uth.tmc.edu.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Green', 'Affiliation': 'Department of Pediatrics - Center for Clinical Research and Evidence-Based Medicine, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA; MD Anderson - UTHealth Graduate School of Biomedical Sciences, Program in Neuroscience, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'de Dios', 'Affiliation': 'Faillace Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vincent', 'Affiliation': 'Faillace Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'F Gerard', 'Initials': 'FG', 'LastName': 'Moeller', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Lane', 'Affiliation': 'Faillace Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Joy M', 'Initials': 'JM', 'LastName': 'Schmitz', 'Affiliation': 'Faillace Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109054']
1824,34600178,The effect of a low-load plyometric running intervention on leg stiffness in youth with cerebral palsy: A randomised controlled trial.,"AIM


To determine whether a running intervention utilising plyometric activities improved leg stiffness in youth with cerebral palsy (CP), GMFCS levels I and II.
METHOD


This stratified randomised controlled trial examined the lower limb kinetics and kinematics of a sample of youths with CP during sub-maximal hopping and running, prior to and immediately following a 12-week running intervention that incorporated low load plyometric training. Included participants were 13 in the control group (mean age 13 years 2 months [SD 2 years 7 months]; six males; nine GMFCS level I; six unilateral) and 18 in the intervention group (mean age 12 years 9 months [SD 2 years 10 months]; 13 males; 11 GMFCS level I; nine unilateral). Derived variables included three-dimensional leg stiffness as well as resultant ground reaction force and change in leg length. Generalised linear mixed models were developed for statistical analysis.
RESULTS


At follow-up the intervention group had greater leg stiffness than the control group during submaximal hopping (Intervention median = 3278Nm -1 ; Control median = 1556Nm -1 ; p < 0.01). At follow-up, participants in the intervention group in GMFCS Level I had greater leg stiffness than the control group during jogging (Intervention mean=38.84 (SD=25.55); Control mean=29.38 (SD=11.11); t = 2.61 p = 0.01).
INTERPRETATION


A running training intervention which includes plyometric activities can improve leg stiffness in young people with CP, especially those in GMFCS level I.",2021,At follow-up the intervention group had greater leg stiffness than the control group during submaximal hopping,"['young people with CP, especially those in GMFCS level I', 'Included participants were 13 in the control group (mean age 13 years 2 months [SD 2 years 7 months]; six males; nine GMFCS level I; six unilateral) and 18 in the intervention group (mean age 12 years 9 months', 'youth with cerebral palsy', 'youths with CP during sub-maximal hopping and running, prior to and immediately following a 12-week', 'youth with cerebral palsy (CP), GMFCS levels I and II']","['low-load plyometric running intervention', 'running intervention utilising plyometric activities', 'running intervention that incorporated low load plyometric training', 'submaximal hopping']","['resultant ground reaction force and change in leg length', 'leg stiffness', 'GMFCS Level']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444864', 'cui_str': 'AM 13'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019737', 'cui_str': 'HLA-B antigen'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0426952', 'cui_str': 'Leg length'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0356121,At follow-up the intervention group had greater leg stiffness than the control group during submaximal hopping,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chappell', 'Affiliation': 'School of Physiotherapy and Exercise Sciences, Curtin University, Kent St., Bentley, Western Australia 6102, Australia. Electronic address: annie@westernkidshealth.com.'}, {'ForeName': 'G T', 'Initials': 'GT', 'LastName': 'Allison', 'Affiliation': 'School of Physiotherapy and Exercise Sciences, Curtin University, Kent St., Bentley, Western Australia 6102, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gibson', 'Affiliation': ""Perth Children's Hospital, Locked Bag 2010, Nedlands, Western Australia 6909, Australia.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'School of Health Sciences, University of Melbourne, Victoria 3010, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'School of Physiotherapy and Exercise Sciences, Curtin University, Kent St., Bentley, Western Australia 6102, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2021.09.194']
1825,34600123,Return to work and productivity loss after surgery: A health economic evaluation.,"BACKGROUND


We aimed to identify preoperative psychosocial factors associated with return-to-work (RTW) and the associated cost of productivity loss due to work absenteeism following surgery. Research demonstrates a high economic burden from productivity loss after surgery, but the comparative cost of productivity loss relative to income across different operations has not been examined.
MATERIALS AND METHODS


A mixed surgical cohort recruited for a randomized controlled trial were prospectively followed for up to two years following surgery with daily phone assessments to three months, weekly assessments thereafter to six months, then monthly assessments thereafter to determine RTW status, opioid use and pain.
RESULTS


183 of 207 (88.3%) patients in paid employment prior to surgery, who provided at least one day of follow-up, were included in this analysis. The average cost of productivity loss due to work absenteeism was $13 761 (median $9064). Patients who underwent total knee replacement incurred the highest income loss. Medical claims filed before surgery were significantly associated with relative income loss (AOR 5.09; 95% CI 1.73-14.96; p < 0.01) and delayed postoperative RTW. Elevated preoperative PTSD symptoms were associated with delayed RTW (HR 0.78; 95%CI 0.63-0.96; p-value = 0.02) while male gender (HR 1.63; 95%CI 1.11-2.38; p-value = 0.01) was associated with faster postoperative RTW.
CONCLUSION


Surgery places a high economic burden on individuals due to postoperative productivity loss. Multidisciplinary approaches, such as pathways, that facilitate the operation and recovery may mitigate the economic consequences for patients, employers, and the healthcare system.",2021,"Elevated preoperative PTSD symptoms were associated with delayed RTW (HR 0.78; 95%CI 0.63-0.96; p-value = 0.02) while male gender (HR 1.63; 95%CI 1.11-2.38; p-value = 0.01) was associated with faster postoperative RTW.
","['183 of 207 (88.3%) patients in paid employment prior to surgery, who provided at least one day of follow-up']",['total knee replacement'],"['Elevated preoperative PTSD symptoms', 'average cost of productivity loss', 'delayed postoperative RTW']","[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1320371', 'cui_str': 'In paid employment'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}]",,0.0977731,"Elevated preoperative PTSD symptoms were associated with delayed RTW (HR 0.78; 95%CI 0.63-0.96; p-value = 0.02) while male gender (HR 1.63; 95%CI 1.11-2.38; p-value = 0.01) was associated with faster postoperative RTW.
","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Hah', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford, CA, USA. Electronic address: jhah@stanford.edu.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Centre for Economic Impacts of Genomic Medicine, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Rupendra', 'Initials': 'R', 'LastName': 'Shrestha', 'Affiliation': 'Centre for Economic Impacts of Genomic Medicine, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Pirrotta', 'Affiliation': 'Stanford Systems Neuroscience and Pain Lab, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Huddleston', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'Department of Orthopaedic Surgery and (by courtesy) Bioengineering, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Derek F', 'Initials': 'DF', 'LastName': 'Amanatullah', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Dirbas', 'Affiliation': 'Department of General Surgery, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Carroll', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schofield', 'Affiliation': 'Centre for Economic Impacts of Genomic Medicine, Macquarie University, Sydney, NSW, Australia.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106100']
1826,34601450,"Effects of an eight-week, online mindfulness program on anxiety and depression in university students during COVID-19: A randomized controlled trial.","The COVID-19 pandemic has had adverse mental health effects for many groups in British society, especially young adults and university students. The present study reports secondary outcomes (i.e., symptoms of anxiety and depression) from a randomized waitlist controlled trial, with a one-month post-intervention follow-up, on the effects of a guided, eight-week mindfulness program delivered online during the COVID-19 pandemic among students at the University of Oxford. Longitudinal multilevel models showed greater reductions in anxiety but not depression symptoms for participants in the mindfulness condition relative to participants in the waitlist control condition (time X group B=-0.36, p=.025).",2021,"Longitudinal multilevel models showed greater reductions in anxiety but not depression symptoms for participants in the mindfulness condition relative to participants in the waitlist control condition (time X group B=-0.36, p=.025).","['young adults and university students', 'university students during COVID-19']",['online mindfulness program'],"['anxiety', 'anxiety and depression', 'symptoms of anxiety and depression']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0490751,"Longitudinal multilevel models showed greater reductions in anxiety but not depression symptoms for participants in the mindfulness condition relative to participants in the waitlist control condition (time X group B=-0.36, p=.025).","[{'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Simonsson', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, Madison, WI, USA; Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institute, Sweden; Department of Sociology, University of Oxford, UK. Electronic address: simonsson@wisc.edu.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bazin', 'Affiliation': 'Independent Mindfulness Practitioner.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Fisher', 'Affiliation': 'Department of Sociology, University of Oxford, UK.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, Madison, WI, USA; Department of Counseling Psychology, University of Wisconsin - Madison, Madison, WI, USA.'}]",Psychiatry research,['10.1016/j.psychres.2021.114222']
1827,34600960,Changes of functional connectivity of the subgenual anterior cingulate cortex and precuneus after cognitive behavioral therapy combined with fluoxetine in young depressed patients with suicide attempt.,"This single-center, randomized, single-blind, parallel-controlled study aimed to analyze the changes in resting-state functional connectivity (RSFC) in young patients with a suicide attempt caused by depression before and after cognitive-behavioral therapy (CBT) combined with fluoxetine or fluoxetine alone by functional magnetic resonance imaging (fMRI). Before treatment, functional connectivity of the right subgenual anterior cingulate cortex (R-sgACC), left subgenual anterior cingulate cortex (L-sgACC) and right precuneus (R-PCu) was lower in depressed patients with a suicide attempt than that of healthy controls. After treatment, compared with the fluoxetine group, functional connectivity between the R-sgACC and left posterior cerebellar lobe in the CBT group was increased, while this group also showed increased RSFC between the L-sgACC and right anterior cingulate cortex/ medial prefrontal cortex. On the contrary, the functional connectivity between the R-PCu and right parietal lobe was reduced (P < 0.001). It was also found there were some changes in different brain regions in pre- and post-treatment within both the CBT and MG group. The functional connectivity of the R-sgACC and the left posterior cerebellum lobe was negatively correlated with the SSI score. The functional connectivity of the R-PCu and right middle frontal cortex was negatively correlated with the HAMD score before treatment. After treatment, functional connectivity between the R-PCu and right superior frontal gyrus was positively correlated with the SSI scores in the CBT group. After 8 weeks of combined CBT, the strength of the functional connectivity in the bilateral sgACC and bilateral PCu was significantly changed.",2022,The functional connectivity of the R-sgACC and the left posterior cerebellum lobe was negatively correlated with the SSI score.,"['young depressed patients with suicide attempt', 'young patients with a suicide attempt caused by depression before and after cognitive-behavioral therapy (CBT) combined with', 'depressed patients with a suicide attempt than that of healthy controls']","['fluoxetine', 'cognitive behavioral therapy combined with fluoxetine', 'fluoxetine or fluoxetine alone by functional magnetic resonance imaging (fMRI']","['strength of the functional connectivity in the bilateral sgACC and bilateral PCu', 'RSFC', 'resting-state functional connectivity (RSFC', 'functional connectivity between the R-PCu and right parietal lobe', 'functional connectivity', 'SSI scores', 'functional connectivity of the right subgenual anterior cingulate cortex (R-sgACC), left subgenual anterior cingulate cortex (L-sgACC) and right precuneus (R-PCu', 'functional connectivity of the R-PCu and right middle frontal cortex', 'SSI score', 'functional connectivity between the R-sgACC and left posterior cerebellar lobe', 'HAMD score']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0228207', 'cui_str': 'Right parietal lobe structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0456856', 'cui_str': 'Left posterior'}, {'cui': 'C0458396', 'cui_str': 'Cerebellar lobe structure'}]",,0.0149305,The functional connectivity of the R-sgACC and the left posterior cerebellum lobe was negatively correlated with the SSI score.,"[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': ""Department of Psychiatry, The Second People's Hospital of Guizhou Province, Guiyang 550004, Guizhou, China. Electronic address: syp_8053@163.com.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': ""Department of Psychiatry, The Second People's Hospital of Guizhou Province, Guiyang 550004, Guizhou, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Bi', 'Affiliation': ""Department of Psychosomatic, The Second People's Hospital of Guizhou Province, Guiyang 550004, Guizhou, China.""}, {'ForeName': 'Jiaoying', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Psychiatry, The Second People's Hospital of Guizhou Province, Guiyang 550004, Guizhou, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': ""Department of Psychiatry, The Second People's Hospital of Guizhou Province, Guiyang 550004, Guizhou, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Kuang', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.'}]",Behavioural brain research,['10.1016/j.bbr.2021.113612']
1828,34600945,Monitoring a meat-free pledge with smartphones: An experimental study.,"Pledges are a popular strategy to encourage meat reduction, though experimental studies of their efficacy are lacking. Three-hundred and twenty-five participants from three different countries (UK, Germany, Australia) were randomly assigned to pledge 28 days meat-free or not, and their behavior was tracked via smartphones. Participants answered daily surveys regarding their eating behavior, meat cravings, and shared photos of their meals. Baseline data was collected prior to the pledge, after the 28 days, and one-month post-intervention. Participants assigned to the pledge condition ate less meat across the 28 days, compared to control participants. Meat reductions, observed at outtake, did not endure one-month post-intervention. Overall, German participants ate the least amount of meat, and showed the sharpest decrease in consumption when pledging. Meat cravings tended to increase among pledgers, relative to control participants. Pledgers who reported high starting intentions and conflict about meat tended to eat less meat and reported fewer cravings. All participants reported reduced meat-eating justifications one-month post-intervention. These findings provide experimental evidence that pledges can encourage meat consumers to reduce their intake, though additional mechanisms are needed to sustain commitments.",2021,Pledgers who reported high starting intentions and conflict about meat tended to eat less meat and reported fewer cravings.,"['Three-hundred and twenty-five participants from three different countries (UK, Germany, Australia']",['meat-free pledge with smartphones'],"['eating behavior, meat cravings, and shared photos of their meals', 'Meat reductions', 'Meat cravings']","[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",325.0,0.163352,Pledgers who reported high starting intentions and conflict about meat tended to eat less meat and reported fewer cravings.,"[{'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Piazza', 'Affiliation': 'Lancaster University, Department of Psychology, Lancaster, LA1 4YF, UK. Electronic address: j.piazza@lancaster.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gregson', 'Affiliation': 'Lancaster University, Department of Psychology, Lancaster, LA1 4YF, UK.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Kordoni', 'Affiliation': 'Lancaster University, Department of Psychology, Lancaster, LA1 4YF, UK.'}, {'ForeName': 'Tamara M', 'Initials': 'TM', 'LastName': 'Pfeiler', 'Affiliation': 'Johannes Gutenberg-Universität Mainz, Department of Psychology, Binger Str. 14-16, 55099, Mainz, Germany.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Ruby', 'Affiliation': 'La Trobe University, School of Psychology and Public Health, Wodonga VIC, 3690, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ellis', 'Affiliation': 'University of Bath, School of Management, Claverton Down Rd, Claverton Down, Bath, BA2 7AY, UK.'}, {'ForeName': 'Ensu', 'Initials': 'E', 'LastName': 'Sahin', 'Affiliation': 'La Trobe University, School of Psychology and Public Health, Wodonga VIC, 3690, Australia.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Reith', 'Affiliation': 'Johannes Gutenberg-Universität Mainz, Department of Psychology, Binger Str. 14-16, 55099, Mainz, Germany.'}]",Appetite,['10.1016/j.appet.2021.105726']
1829,34607574,Impact of empagliflozin on right ventricular parameters and function among patients with type 2 diabetes.,"BACKGROUND


Sodium-glucose cotransporter 2 (SGLT2) inhibition reduces cardiovascular events in type 2 diabetes (T2DM) and is associated with a reduction in left ventricular (LV) mass index. However, the impact on right ventricular (RV) remodeling is unknown. Accordingly, the objective of this study was to assess the impact of SGLT2 inhibition on RV parameters and function in T2DM and coronary artery disease (CAD).
METHODS


In EMPA-HEART CardioLink-6, 97 patients with T2DM and CAD were randomly assigned to empagliflozin 10 mg (n = 49) once daily or placebo (n = 48). Cardiac magnetic resonance imaging was performed at baseline and after 6 months. RV mass index (RVMi), RV end-diastolic and end-systolic volume index (RVEDVi, RVESVi) and RV ejection fraction (RVEF) were assessed in blinded fashion.
RESULTS


At baseline, mean RVMi (± SD) (11.8 ± 2.4 g/m 2 ), RVEF (53.5 ± 4.8%), RVEDVi (64.3 ± 13.2 mL/m 2 ) and RVESVi (29.9 ± 6.9 mL/m 2 ) were within normal limits and were similar between the empagliflozin and placebo groups. Over 6 months, there were no significant differences in RVMi (- 0.11 g/m 2 , [95% CI - 0.81 to 0.60], p = 0.76), RVEF (0.54%, [95% CI - 1.4 to 2.4], p = 0.58), RVEDVi (- 1.2 mL/m 2 , [95% CI - 4.1 to 1.7], p = 0.41) and RVESVi (- 0.81 mL/m 2 , [95% CI - 2.5 to 0.90], p = 0.35) in the empaglifozin group as compared with the placebo group. In both groups, there was no significant correlation between RVMi and LVMi changes from baseline to 6 months.
CONCLUSIONS


In this post-hoc analysis, SGLT2 inhibition with empagliflozin had no impact on RVMi and RV volumes in patients with T2DM and CAD. The potentially differential effect of empagliflozin on the LV and RV warrants further investigation.
CLINICAL TRIAL REGISTRATION


URL:  https://www.clinicaltrials.gov/ct2/show/NCT02998970?cond=NCT02998970&draw=2&rank=1 . Unique identifier: NCT02998970.",2021,"In this post-hoc analysis, SGLT2 inhibition with empagliflozin had no impact on RVMi and RV volumes in patients with T2DM and CAD.","['patients with T2DM and CAD', 'patients with type 2 diabetes', '97 patients with T2DM and CAD']","['Sodium-glucose cotransporter 2 (SGLT2) inhibition', 'placebo', 'empagliflozin', 'empaglifozin']","['RVEF', 'mean RVMi (±\u2009SD', 'RV mass index (RVMi), RV end-diastolic and end-systolic volume index (RVEDVi, RVESVi) and RV ejection fraction (RVEF', 'right ventricular (RV) remodeling', 'RVMi', 'RVMi and LVMi changes', 'RVMi and RV volumes', 'RV parameters and function in T2DM and coronary artery disease (CAD', 'RVESVi']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0455860', 'cui_str': 'Right ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0428781', 'cui_str': 'Right ventricular ejection fraction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]",97.0,0.472557,"In this post-hoc analysis, SGLT2 inhibition with empagliflozin had no impact on RVMi and RV volumes in patients with T2DM and CAD.","[{'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Sarak', 'Affiliation': ""Division of Cardiology, Terrence Donnelly Heart Centre, St Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'David Mazer', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hwee', 'Initials': 'H', 'LastName': 'Teoh', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Quan', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Gilbert', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Division of Cardiology, Terrence Donnelly Heart Centre, St Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.""}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Bami', 'Affiliation': ""Division of Cardiology, Terrence Donnelly Heart Centre, St Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.""}, {'ForeName': 'Otávio R', 'Initials': 'OR', 'LastName': 'Coelho-Filho', 'Affiliation': 'Department of Internal Medicine, Discipline of Cardiology, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Vineeta', 'Initials': 'V', 'LastName': 'Ahooja', 'Affiliation': 'Heart Health Institute, Toronto, ON, Canada.'}, {'ForeName': 'Djeven P', 'Initials': 'DP', 'LastName': 'Deva', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Garg', 'Affiliation': ""Division of Cardiology, Terrence Donnelly Heart Centre, St Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.""}, {'ForeName': 'Sumeet', 'Initials': 'S', 'LastName': 'Gandhi', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Connelly', 'Affiliation': ""Division of Cardiology, Terrence Donnelly Heart Centre, St Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. kim.connelly@unityhealth.to.""}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Yan', 'Affiliation': ""Division of Cardiology, Terrence Donnelly Heart Centre, St Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. andrew.yan@unityhealth.to.""}]",Cardiovascular diabetology,['10.1186/s12933-021-01390-8']
1830,34606989,The COVID-19 Self-Testing through Rapid Network Distribution (C-STRAND) trial: A randomized controlled trial to increase COVID-19 testing in underserved populations.,"Background Widely available population testing is critical to public health efforts to control the ongoing COVID-19 pandemic. However, COVID-19 testing has been low in underserved communities disproportionately affected by COVID-19. One approach to increase testing rates is through the secondary distribution of self-collection kits, where an individual distributes test kits to contacts in their social network and encourages them to self-collect test specimens. We outline a randomized clinical trial, COVID-19 Self-testing Through Rapid Network Distribution (C-STRAND), and a cohort study of individuals with COVID-19, to determine the impact of a secondary distribution strategy on COVID-19 testing among medically underserved populations. Methods The clinical trial will seek to enroll 1048 adult index participants from federally health qualified centers in Philadelphia, PA seeking COVID-19 testing. Eligible participants will be randomized 1:1 to receive multiple self-collection test kits or multiple referrals for standard clinic-based tests to distribute to contacts within their social network. The primary outcome will be testing among at least two network contacts at 8 weeks. Index participants and network contacts who test positive for COVID-19 from C-STRAND will be eligible to join the COVID-19 Close Contact Self-testing Study (CloseST), assessing the secondary distribution of self-collection test kits among individuals with COVID-19. The primary outcome of this cohort will be the number of close contacts who test positive at 8 weeks. Conclusion Novel strategies to promote COVID-19 testing are necessary, particularly among underserved populations most affected by COVID-19. We will determine the efficacy of a self-testing secondary distribution strategy. The results may inform efforts to increase testing rates during the current pandemic.",2021,"We outline a randomized clinical trial, COVID-19 Self-testing Through Rapid Network Distribution (C-STRAND), and a cohort study of individuals with COVID-19, to determine the impact of a secondary distribution strategy on COVID-19 testing among medically underserved populations.","['Eligible participants', 'individuals with COVID-19', 'underserved populations', 'medically underserved populations', '1048 adult index participants from federally health qualified centers in Philadelphia, PA seeking COVID-19 testing']",['multiple self-collection test kits or multiple referrals for standard clinic-based tests to distribute to contacts within their social network'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C4551781', 'cui_str': 'Medically Underserved Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",[],1048.0,0.330967,"We outline a randomized clinical trial, COVID-19 Self-testing Through Rapid Network Distribution (C-STRAND), and a cohort study of individuals with COVID-19, to determine the impact of a secondary distribution strategy on COVID-19 testing among medically underserved populations.","[{'ForeName': 'Cedric H', 'Initials': 'CH', 'LastName': 'Bien-Gund', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, USA. Electronic address: cedric.bien-gund@pennmedicine.upenn.edu.'}, {'ForeName': 'Jesal', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, USA.'}, {'ForeName': 'Joshua I', 'Initials': 'JI', 'LastName': 'Ho', 'Affiliation': 'Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, USA.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Shea', 'Affiliation': 'Public Health Management Corporation, Philadelphia, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fishman', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, USA.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Division of Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Acri', 'Affiliation': 'Courage Medicine Health Center, Philadelphia, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dugosh', 'Affiliation': 'Public Health Management Corporation, Philadelphia, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, USA; Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106585']
1831,34606988,Integrating tobacco treatment into lung cancer screening practices: Study protocol for the Screen ASSIST randomized clinical trial.,"BACKGROUND


Integrating tobacco treatment services into lung cancer screening (LCS) has the potential to leverage a 'teachable moment' to promote cessation among long-term smokers and reduce disparities in tobacco treatment access. This protocol paper describes the Screen ASSIST (Aiding Screening Support In Stopping Tobacco) trial, which will identify how to best deliver evidence-driven tobacco treatment in the context of LCS.
METHODS


Screen ASSIST is a randomized clinical trial with a 3-factor, fully crossed factorial design that enrolls current smokers (any cigarette use in the past 30 days) scheduled to attend LCS at multiple sites in the Mass General Brigham healthcare system. To maximize reach, recruitment is conducted at 3 time points: 1) at the time of LCS scheduling, 2) at the LCS visit, and 3) after the participant has received their LCS results. Participants are stratified by LCS study site and recruitment point and randomly assigned into 8 groups that test intervention components varying on telehealth counseling duration (4 weeks vs. 8 weeks), nicotine replacement therapy duration (2 weeks vs. 8 weeks), and systematic screening and referral for social determinants of health via a service named 'AuntBertha' (referral vs. no referral). The primary study outcome is self-reported past 7-day tobacco abstinence at 6-month follow-up. This trial will also assess systems integration and evaluate implementation of the intervention.
DISCUSSION


Screen ASSIST will identify the most effective combination of tobacco cessation treatments within the LCS context, in order to improve the cost-effectiveness of LCS and quality of life among long-term heavy smokers.",2021,"This protocol paper describes the Screen ASSIST (Aiding Screening Support in Stopping Tobacco) trial, which will identify how to best deliver evidence-driven tobacco treatment in the context of LCS.
","['enrolls current smokers (any cigarette use in the past 30\u202fdays) scheduled to attend LCS at multiple sites in the Mass General Brigham healthcare system', 'lung cancer screening practices']","[""nicotine replacement therapy duration (2\u202fweeks vs. 8\u202fweeks), and systematic screening and referral for social determinants of health via a service named 'AuntBertha' (referral vs. no referral"", 'test intervention components varying on telehealth counseling duration']","['self-reported past 7-day tobacco abstinence', 'cost-effectiveness of LCS and quality of life']","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C3658315', 'cui_str': 'Social Determinants of Health'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.215881,"This protocol paper describes the Screen ASSIST (Aiding Screening Support in Stopping Tobacco) trial, which will identify how to best deliver evidence-driven tobacco treatment in the context of LCS.
","[{'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Neil', 'Affiliation': 'Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States of America; TSET Health Promotion Research Center, Stephenson Cancer Center, Oklahoma City, OK, United States of America; Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America. Electronic address: Jordan-Neil@ouhsc.edu.'}, {'ForeName': 'Caylin', 'Initials': 'C', 'LastName': 'Marotta', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Gonzalez', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Levy', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Tobacco Research and Treatment Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wint', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Harris', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Saif', 'Initials': 'S', 'LastName': 'Hawari', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Noonan', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Styklunas', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Crute', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Sydney E', 'Initials': 'SE', 'LastName': 'Howard', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Sheppard', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Inga T', 'Initials': 'IT', 'LastName': 'Lennes', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Jacobson', 'Affiliation': ""Department of Radiology, Brigham and Women's Faulkner Hospital, Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Efren J', 'Initials': 'EJ', 'LastName': 'Flores', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Tobacco Research and Treatment Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Tobacco Research and Treatment Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106586']
1832,34606938,Cook Like A Boss: An effective co-created multidisciplinary approach to improving children's cooking competence.,"Cooking interventions are emphasised as promising methods for changing children's food-related preferences, attitudes and behaviours. However, criticisms remain, including relatively weak intervention designs; lack of validated tools, and limited underpinning theory. Therefore, this research aimed to assess the effectiveness of a theory-driven co-created children's cooking intervention with underpinning rationale for the content, using a validated measure. 'Cook Like A Boss' was a one week, controlled cooking camp style intervention. Thirty two children aged 10-12 years participated. The intervention was developed using the Cook-Ed model for planning, implementing and evaluating cooking programs and was underpinned by Social Learning theory and Experiential Learning theory. The intervention content was developed in a co-creation process with the research team, a chef and the children. The underlying developmental skills required for the recipes were assessed to ensure they were age-appropriate. Children completed pre and post measurements including perceived cooking competence. Process evaluations were also gathered. There was a significant increase in perceived cooking competence after the intervention (P < 0.05) and a significant difference between the intervention and control group (P < 0.001). Additionally, process evaluations found the intervention to have high fidelity and dose received and that it was received extremely positively. The 'Cook Like A Boss' children's cooking camp was an effective multidisciplinary co-created intervention with a vulnerable group, e.g. children, guided by a model and underpinned by theory. The content was developed to ensure it was age-appropriate and achievable for the children. This approach could act as a template for future children's cooking interventions.",2021,There was a significant increase in perceived cooking competence after the intervention (P < 0.05) and a significant difference between the intervention and control group (P < 0.001).,"['Thirty two children aged 10-12 years participated', ""children's cooking competence""]","['Cook-Ed model for planning, implementing and evaluating cooking programs and was underpinned by Social Learning theory and Experiential Learning theory', ""theory-driven co-created children's cooking intervention"", 'Cooking interventions', 'Cook', 'Cook Like A Boss', 'controlled cooking camp style intervention']",['perceived cooking competence'],"[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3714362', 'cui_str': 'Social learning theory'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",32.0,0.0217102,There was a significant increase in perceived cooking competence after the intervention (P < 0.05) and a significant difference between the intervention and control group (P < 0.001).,"[{'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Dean', 'Affiliation': ""Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, UK.""}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': ""O'Kane"", 'Affiliation': ""Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, UK.""}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Issartel', 'Affiliation': 'Multisensory Motor Learning Lab, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'McCloat', 'Affiliation': ""School of Home Economics, St. Angela's College, Sligo (National University of Ireland Galway), Ireland.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Mooney', 'Affiliation': ""School of Home Economics, St. Angela's College, Sligo (National University of Ireland Galway), Ireland.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'McKernan', 'Affiliation': ""Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, UK.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': ""Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, UK.""}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': ""O'Kane"", 'Affiliation': ""Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, UK.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Crowe', 'Affiliation': ""Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, UK.""}, {'ForeName': 'Blain', 'Initials': 'B', 'LastName': 'Murphy', 'Affiliation': ""Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, UK.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lavelle', 'Affiliation': ""Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, UK. Electronic address: flavelle01@qub.ac.uk.""}]",Appetite,['10.1016/j.appet.2021.105727']
1833,34609548,Effect of oral chlorhexidine de-adoption and implementation of an oral care bundle on mortality for mechanically ventilated patients in the intensive care unit (CHORAL): a multi-center stepped wedge cluster-randomized controlled trial.,"PURPOSE


Oral chlorhexidine is used widely for mechanically ventilated patients to prevent pneumonia, but recent studies show an association with excess mortality. We examined whether de-adoption of chlorhexidine and parallel implementation of a standardized oral care bundle reduces intensive care unit (ICU) mortality in mechanically ventilated patients.
METHODS


A stepped wedge cluster-randomized controlled trial with concurrent process evaluation in 6 ICUs in Toronto, Canada. Clusters were randomized to de-adopt chlorhexidine and implement a standardized oral care bundle at 2-month intervals. The primary outcome was ICU mortality. Secondary outcomes were time to infection-related ventilator-associated complications (IVACs), oral procedural pain and oral health dysfunction. An exploratory post hoc analysis examined time to extubation in survivors.
RESULTS


A total of 3260 patients were enrolled; 1560 control, 1700 intervention. ICU mortality for the intervention and control periods were 399 (23.5%) and 330 (21.2%), respectively (adjusted odds ratio [aOR], 1.13; 95% confidence interval [CI] 0.82 to 1.54; P = 0.46). Time to IVACs (adjusted hazard ratio [aHR], 1.06; 95% CI 0.44 to 2.57; P = 0.90), time to extubation (aHR 1.03; 95% CI 0.85 to 1.23; P = 0.79) (survivors) and oral procedural pain (aOR, 0.62; 95% CI 0.34 to 1.10; P = 0.10) were similar between control and intervention periods. However, oral health dysfunction scores (- 0.96; 95% CI - 1.75 to - 0.17; P = 0.02) improved in the intervention period.
CONCLUSION


Among mechanically ventilated ICU patients, no benefit was observed for de-adoption of chlorhexidine and implementation of an oral care bundle on ICU mortality, IVACs, oral procedural pain, or time to extubation. The intervention may improve oral health.",2021,"Among mechanically ventilated ICU patients, no benefit was observed for de-adoption of chlorhexidine and implementation of an oral care bundle on ICU mortality, IVACs, oral procedural pain, or time to extubation.","['A total of 3260 patients were enrolled; 1560 control, 1700 intervention', 'mechanically ventilated patients', 'mechanically ventilated patients in the intensive care unit (CHORAL', 'mechanically ventilated patients to prevent pneumonia', 'mechanically ventilated ICU patients', '6 ICUs in Toronto, Canada']","['chlorhexidine', 'oral chlorhexidine']","['oral procedural pain', 'ICU mortality, IVACs, oral procedural pain, or time to extubation', 'oral health dysfunction scores', 'Time to IVACs', 'time to infection-related ventilator-associated complications (IVACs), oral procedural pain and oral health dysfunction', 'oral health', 'time to extubation', 'ICU mortality']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",3260.0,0.236809,"Among mechanically ventilated ICU patients, no benefit was observed for de-adoption of chlorhexidine and implementation of an oral care bundle on ICU mortality, IVACs, oral procedural pain, or time to extubation.","[{'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Dale', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T 1P8, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': ""Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, 57 Waterloo Road, Room 1.1.3, London, SE1 8WA, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Carbone', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T 1P8, Canada.'}, {'ForeName': 'Ruxandra', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada.'}, {'ForeName': 'Orla M', 'Initials': 'OM', 'LastName': 'Smith', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T 1P8, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Burry', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, Faculty of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Fan', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, Faculty of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Andre Carlos Kajdacsy-Balla', 'Initials': 'ACK', 'LastName': 'Amaral', 'Affiliation': 'Sunnybrook Research Institute, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'McCredie', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, Faculty of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Damon C', 'Initials': 'DC', 'LastName': 'Scales', 'Affiliation': 'Sunnybrook Research Institute, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Cuthbertson', 'Affiliation': 'Sunnybrook Research Institute, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada. Brian.Cuthbertson@sunnybrook.ca.'}]",Intensive care medicine,['10.1007/s00134-021-06475-2']
1834,34609547,"Sodium chloride or Plasmalyte-148 evaluation in severe diabetic ketoacidosis (SCOPE-DKA): a cluster, crossover, randomized, controlled trial.","PURPOSE


To determine whether treatment with Plasmalyte-148 (PL) compared to sodium chloride 0.9% (SC) results in faster resolution of diabetic ketoacidosis (DKA) and whether the acetate in PL potentiates ketosis.
METHODS


We conducted a cluster, crossover, open-label, randomized, controlled Phase 2 trial at seven hospitals in adults admitted to intensive care unit (ICU) with severe DKA with hospital randomised to PL or SC as fluid therapy. The primary outcome, DKA resolution, was defined as a change in base excess to ≥ - 3 mEq/L at 48 h.
RESULTS


Ninety-three patients were enrolled with 90 patients included in the modified-intention-to-treat population (PL n = 48, SC n = 42). At 48 h, mean fluid administration was 6798 ± 4850 ml vs 6574 ± 3123 ml, median anion gap 6 mEq/L (IQR 5-7) vs 7 mEq/L (IQR 5-7) and median blood ketones 0.3 mmol/L (IQR 0.1-0.5) vs 0.3 (IQR 0.1-0.5) in the PL and SC groups. DKA resolution at 48 h occurred in 96% (PL) and 86% (SC) of patients; odds ratio 3.93 (95% CI 0.73-21.16, p = 0.111). At 24 h, DKA resolution occurred in 69% (PL) and 36% (SC) of patients; odds ratio 4.24 (95% CI 1.68-10.72, p = 0.002). The median ICU and hospital lengths of stay were 49 h (IQR 23-72) vs 55 h (IQR 41-80) and 81 h (IQR 58-137) vs 98 h (IQR 65-195) in the PL and SC groups.
CONCLUSION


Plasmalyte-148, compared to sodium chloride 0.9%, may lead to faster resolution of metabolic acidosis in patients with DKA without an increase in ketosis. These findings need confirmation in a large, Phase 3 trial.",2021,"DKA resolution at 48 h occurred in 96% (PL) and 86% (SC) of patients; odds ratio 3.93 (95% CI 0.73-21.16, p = 0.111).","['severe diabetic ketoacidosis (SCOPE-DKA', 'seven hospitals in adults admitted to intensive care unit (ICU) with severe DKA with hospital randomised to PL or SC as fluid therapy', 'Ninety-three patients were enrolled with 90 patients included in the modified-intention-to-treat population (PL n\u2009=\u200948, SC n\u2009=\u200942']","['Sodium chloride or Plasmalyte-148 evaluation', 'sodium chloride 0.9% (SC', 'Plasmalyte-148 (PL', 'sodium chloride']","['median blood ketones', 'median ICU and hospital lengths of stay', 'metabolic acidosis', 'diabetic ketoacidosis (DKA', 'DKA resolution', 'ketosis']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0071213', 'cui_str': 'Plasmalyte A'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0071213', 'cui_str': 'Plasmalyte A'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}]",93.0,0.372555,"DKA resolution at 48 h occurred in 96% (PL) and 86% (SC) of patients; odds ratio 3.93 (95% CI 0.73-21.16, p = 0.111).","[{'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Ramanan', 'Affiliation': 'Intensive Care Unit, Caboolture Hospital, McKean Street, Caboolture, QLD, 4510, Australia. Mahesh.ramanan@health.qld.gov.au.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Attokaran', 'Affiliation': 'Intensive Care Unit, Rockhampton Hospital, Canning Street, Rockhampton, QLD, 4700, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Intensive Care Unit, Sunshine Coast University Hospital, Doherty Street, Birtinya, QLD, 4575, Australia.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Bhadange', 'Affiliation': 'Intensive Care Unit, Ipswich Hospital, Chelmsford Avenue, Ipswich, QLD, 4305, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stewart', 'Affiliation': 'Intensive Care Unit, Queen Elizabeth-2 Jubilee Hospital, Kessels Road, Coopers Plains, QLD, 4108, Australia.'}, {'ForeName': 'Gokulnath', 'Initials': 'G', 'LastName': 'Rajendran', 'Affiliation': 'Intensive Care Unit, Mackay Base Hospital, Bridge Road, Mackay, QLD, 4741, Australia.'}, {'ForeName': 'Raju', 'Initials': 'R', 'LastName': 'Pusapati', 'Affiliation': 'Intensive Care Unit, Hervey Bay Hospital, Urraween Road, Pialba, QLD, 4655, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Petty', 'Affiliation': 'Intensive Care Unit, Caboolture Hospital, McKean Street, Caboolture, QLD, 4510, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Garrett', 'Affiliation': 'Intensive Care Unit, Sunshine Coast University Hospital, Doherty Street, Birtinya, QLD, 4575, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kruger', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD, 4102, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Peake', 'Affiliation': 'Department of Intensive Care Medicine, The Queen Elizabeth Hospital, Woodville Road, Woodville South, South Australia, 5011, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Level 5/1 King Street, Newtown, NSW, 2042, Australia.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Level 5/1 King Street, Newtown, NSW, 2042, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-021-06480-5']
1835,34048027,Interaction Between SNP Genotype and Efficacy of Anastrozole and Exemestane in Early-Stage Breast Cancer.,"Aromatase inhibitors (AIs) are the treatment of choice for hormone receptor-positive early breast cancer in postmenopausal women. None of the third-generation AIs are superior to the others in terms of efficacy. We attempted to identify genetic factors that could differentiate between the effectiveness of adjuvant anastrozole and exemestane by examining single-nucleotide polymorphism (SNP)-treatment interaction in 4,465 patients. A group of SNPs were found to be differentially associated between anastrozole and exemestane regarding outcomes. However, they showed no association with outcome in the combined analysis. We followed up common SNPs near LY75 and GPR160 that could differentiate anastrozole from exemestane efficacy. LY75 and GPR160 participate in epithelial-to-mesenchymal transition and growth pathways, in both cases with SNP-dependent variation in regulation. Collectively, these studies identified SNPs that differentiate the efficacy of anastrozole and exemestane and they suggest additional genetic biomarkers for possible use in selecting an AI for a given patient.",2021,None of the third-generation AIs are superior to the others in terms of efficacy.,"['Early-Stage Breast Cancer', '4,465 patients', 'postmenopausal women']","['Anastrozole and Exemestane', 'anastrozole and exemestane', 'adjuvant anastrozole and exemestane', 'Aromatase inhibitors (AIs']",[],"[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}]",[],4465.0,0.103394,None of the third-generation AIs are superior to the others in terms of efficacy.,"[{'ForeName': 'Junmei', 'Initials': 'J', 'LastName': 'Cairns', 'Affiliation': 'Division of Clinical Pharmacology, Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Krishna R', 'Initials': 'KR', 'LastName': 'Kalari', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Ingle', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Shepherd', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Department of Medicine, Baylor University College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Goss', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Harvard University, Boston, Massachusetts, USA.'}, {'ForeName': 'Poulami', 'Initials': 'P', 'LastName': 'Barman', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Carlson', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Goodnature', 'Affiliation': 'Patient Advocate, Mayo Clinic Breast Cancer Specialized Program of Research Excellence, Rochester, Minnesota, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Weinshilboum', 'Affiliation': 'Division of Clinical Pharmacology, Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Huanyao', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Division of Clinical Pharmacology, Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Liewei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Division of Clinical Pharmacology, Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, Minnesota, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2311']
1836,34608333,"Neoadjuvant talimogene laherparepvec plus surgery versus surgery alone for resectable stage IIIB-IVM1a melanoma: a randomized, open-label, phase 2 trial.","Talimogene laherparepvec (T-VEC) is a herpes simplex virus type 1-based intralesional oncolytic immunotherapy approved for the treatment of unresectable melanoma. The present, ongoing study aimed to estimate the treatment effect of neoadjuvant T-VEC on recurrence-free survival (RFS) of patients with advanced resectable melanoma. An open-label, phase 2 trial (NCT02211131) was conducted in 150 patients with resectable stage IIIB-IVM1a melanoma who were randomized to receive T-VEC followed by surgery (arm 1, n = 76) or surgery alone (arm 2, n = 74). The primary endpoint was a 2-year RFS in the intention-to-treat population. Secondary and exploratory endpoints included overall survival (OS), pathological complete response (pCR), safety and biomarker analyses. The 2-year RFS was 29.5% in arm 1 and 16.5% in arm 2 (overall hazard ratio (HR) = 0.75, 80% confidence interval (CI) = 0.58-0.96). The 2-year OS was 88.9% for arm 1 and 77.4% for arm 2 (overall HR = 0.49, 80% CI = 0.30-0.79). The RFS and OS differences between arms persisted at 3 years. In arm 1, 17.1% achieved a pCR. Increased CD8 +  density correlated with clinical outcomes in an exploratory analysis. Arm 1 adverse events were consistent with previous reports for T-VEC. The present study met its primary endpoint and estimated a 25% reduction in the risk of disease recurrence for neoadjuvant T-VEC plus surgery versus upfront surgery for patients with resectable stage IIIB-IVM1a melanoma.",2021,"The 2-year OS was 88.9% for arm 1 and 77.4% for arm 2 (overall HR = 0.49, 80% CI = 0.30-0.79).","['resectable stage IIIB-IVM1a melanoma', '150 patients with resectable stage IIIB-IVM1a melanoma', 'patients with advanced resectable melanoma', 'patients with resectable stage IIIB-IVM1a melanoma']","['surgery alone', 'neoadjuvant T-VEC', 'neoadjuvant T-VEC plus surgery versus upfront surgery', 'T-VEC', 'Talimogene laherparepvec (T-VEC', 'Neoadjuvant talimogene laherparepvec plus surgery versus surgery alone']","['2-year RFS in the intention-to-treat population', '2-year RFS', '2-year OS', 'overall survival (OS), pathological complete response (pCR), safety and biomarker analyses', 'recurrence-free survival (RFS', 'Increased CD8 +  density', 'risk of disease recurrence']","[{'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1831828', 'cui_str': 'talimogene laherparepvec'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}]",150.0,0.390298,"The 2-year OS was 88.9% for arm 1 and 77.4% for arm 2 (overall HR = 0.49, 80% CI = 0.30-0.79).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University Hospital of Zurich, Zurich, Switzerland. Reinhard.Dummer@usz.ch.'}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Gyorki', 'Affiliation': 'Olivia Newton-John Cancer Centre, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hyngstrom', 'Affiliation': 'University of Utah Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Berger', 'Affiliation': 'Thomas Jefferson University Hospitals, Philadelphia, PA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Conry', 'Affiliation': 'University of Alabama School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Demidov', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Treichel', 'Affiliation': 'Amgen Inc., South San Francisco, CA, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Radcliffe', 'Affiliation': 'Amgen Inc., Uxbridge, UK.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Gorski', 'Affiliation': 'Amgen Inc., South San Francisco, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chan', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Faries', 'Affiliation': 'John Wayne Cancer Institute, Santa Monica, CA, USA.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Ross', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Nature medicine,['10.1038/s41591-021-01510-7']
1837,34608329,"Safety and pharmacokinetics of islatravir subdermal implant for HIV-1 pre-exposure prophylaxis: a randomized, placebo-controlled phase 1 trial.","Islatravir (MK-8591) is a highly potent type 1 human immunodeficiency virus (HIV-1) nucleoside reverse transcriptase translocation inhibitor with a long intracellular half-life that is in development for the prevention and treatment of HIV-1. We conducted a randomized, double-blind, placebo-controlled, phase 1 trial in adults without HIV-1 infection. Participants received islatravir or placebo subdermal implants for 12 weeks and were monitored throughout this period and after implant removal. The co-primary end points were safety and tolerability of the islatravir implant and pharmacokinetics, including concentration at day 85, of islatravir triphosphate in peripheral blood mononuclear cells (PBMCs). Secondary end points included additional pharmacokinetic parameters for islatravir triphosphate in PBMCs and the plasma pharmacokinetic profile of islatravir. Based on preclinical data, two doses were assessed: 54 mg (n = 8, two placebo) and 62 mg (n = 8, two placebo). The most frequently reported adverse events were mild-to-moderate implant-site reactions (induration, hematoma, pain). Throughout the 12-week trial, geometric mean islatravir triphosphate concentrations were above a pharmacokinetic threshold of 0.05 pmol per 10 6  PBMCs, which was estimated to provide therapeutic reverse transcriptase inhibition (concentration at day 85 (percentage of geometric coefficient of variation): 54 mg, 0.135 pmol per 10 6  cells (27.3); 62 mg, 0.272 pmol per 10 6  cells (45.2)). Islatravir implants at both doses were safe and resulted in mean concentrations above the pharmacokinetic threshold through 12 weeks, warranting further investigation of islatravir implants as a potential HIV prevention strategy.",2021,"Islatravir implants at both doses were safe and resulted in mean concentrations above the pharmacokinetic threshold through 12 weeks, warranting further investigation of islatravir implants as a potential HIV prevention strategy.",['adults without HIV-1 infection'],"['Islatravir (MK-8591', 'placebo', 'islatravir or placebo subdermal implants', 'islatravir subdermal implant']","['additional pharmacokinetic parameters for islatravir triphosphate in PBMCs and the plasma pharmacokinetic profile of islatravir', 'Safety and pharmacokinetics', 'safety and tolerability of the islatravir implant and pharmacokinetics, including concentration at day 85, of islatravir triphosphate in peripheral blood mononuclear cells (PBMCs', 'geometric mean islatravir triphosphate concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}]","[{'cui': 'C4549592', 'cui_str': 'MK-8591'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0077289', 'cui_str': 'tris(chloroethyl)phosphate'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.383566,"Islatravir implants at both doses were safe and resulted in mean concentrations above the pharmacokinetic threshold through 12 weeks, warranting further investigation of islatravir implants as a potential HIV prevention strategy.","[{'ForeName': 'Randolph P', 'Initials': 'RP', 'LastName': 'Matthews', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Randolph.Matthews@merck.com.'}, {'ForeName': 'Munjal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Barrett', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Haspeslagh', 'Affiliation': 'MSD Belgium, Brussels, Belgium.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Reynders', 'Affiliation': 'MSD Belgium, Brussels, Belgium.'}, {'ForeName': 'Saijuan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Rottey', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Goodey', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Vargo', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Grobler', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Nature medicine,['10.1038/s41591-021-01479-3']
1838,34607283,Significance of inhibitory maternal killer-cell immunoglobulin-like receptor (KIR) and fetal KIR ligand genotype combinations in placenta related obstetric complications.,"Some maternal killer-cell immunoglobulin-like receptor (KIR) and fetal KIR ligand genotypes are associated with obstetric complications, such as recurrent miscarriage, fetal growth restriction, preeclampsia, and preterm birth. However, how KIR/KIR ligand genotypes affect these placenta-related obstetric complications has not been fully understood. We aimed to demonstrate the association of maternal KIR-fetal KIR ligand genotype combinations with immunological/metabolic risk factor associated placenta-related obstetric complications. This study consisted of three groups of pregnant women: 1) Miscarriage group (n = 30), 2) Complicated Pregnancy (CP) group (n = 30), and 3) Control group (n = 30). The observed maternal genotype frequencies of all inhibitory and activating KIRs were similar in all groups (p > 0.05). However, inhibitory 2DL3 was quite frequent in the miscarriage group (p = 0.052). There was no difference between groups in terms of centromeric and telomeric maternal haplotypes (p > 0.05). The fetal group 1 HLA-C genotype was frequently detected in the miscarriage and CP groups with rates of 83.3 % and 93.3 % respectively, while the observed frequency was 70 % in the control group. The fetal group 2 HLA-C genotype was the same in all groups. The results demonstrated significantly less fetal group 2 HLA-C homozygosity in the CP groups when compared to the control group (p = 0.020). The fetal HLA-Bw4 genotype was detected more frequently in the miscarriage and CP groups (p = 0.028 and p = 0.001, respectively). The inhibitory KIR/KIR ligand genotype combinations of 2DL3-C1 and 3DL1-Bw4 were more frequent in the miscarriage and CP groups (p = 0.045 and p = 0.002, respectively). Enhanced NK cell inhibition may be one of the mechanisms underlying placenta-related obstetric complications.",2021,The results demonstrated significantly less fetal group 2 HLA-C homozygosity in the CP groups when compared to the control group (p = 0.020).,"['placenta related obstetric complications', 'three groups of pregnant women: 1) Miscarriage group (n\u2009=\u200930), 2) Complicated Pregnancy (CP) group (n\u2009=\u200930), and 3) Control group (n\u2009=\u200930']",['inhibitory maternal killer-cell immunoglobulin-like receptor (KIR) and fetal KIR ligand genotype combinations'],"['maternal genotype frequencies of all inhibitory and activating KIRs', 'fetal HLA-Bw4 genotype', 'centromeric and telomeric maternal haplotypes', 'HLA-C homozygosity', 'inhibitory 2DL3']","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0178292', 'cui_str': 'Complication of pregnancy, childbirth and/or the puerperium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0032962', 'cui_str': 'Complication of pregnancy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0665952', 'cui_str': 'Killer Cell Immunoglobulin-Like Receptors'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0017550', 'cui_str': 'Kiribati'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0017550', 'cui_str': 'Kiribati'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0062832', 'cui_str': 'HLA-Bw4 antigen'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}, {'cui': 'C0019751', 'cui_str': 'HLA-C antigen'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}]",,0.0421672,The results demonstrated significantly less fetal group 2 HLA-C homozygosity in the CP groups when compared to the control group (p = 0.020).,"[{'ForeName': 'Gokcen', 'Initials': 'G', 'LastName': 'Orgul', 'Affiliation': 'Division of Perinatology, Department of Obstetrics and Gynecology, Faculty of Medicine, Hacettepe University, Turkey. Electronic address: gokcenorgul@gmail.com.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Dalva', 'Affiliation': 'Division of Haematology, Department of Internal Medicine, Ankara University, Turkey. Electronic address: klaradalva@gmail.com.'}, {'ForeName': 'Sevim', 'Initials': 'S', 'LastName': 'Dalva-Aydemir', 'Affiliation': 'Biotechnology Institute, Ankara University, Turkey. Electronic address: sevim.dalva@gmail.com.'}, {'ForeName': 'Ridvan Goksel', 'Initials': 'RG', 'LastName': 'Alniacik', 'Affiliation': 'Division of Haematology, Department of Internal Medicine, Ankara University, Turkey. Electronic address: ridvan2000@gmail.com.'}, {'ForeName': 'Hanife Guler', 'Initials': 'HG', 'LastName': 'Donmez', 'Affiliation': 'Department of Biology, Faculty of Science, Hacettepe University, Ankara, Turkey. Electronic address: hnftnr@gmail.com.'}, {'ForeName': 'Ayse Nur', 'Initials': 'AN', 'LastName': 'Cakar', 'Affiliation': 'Department of Histology and Embryology, TOBB University, Ankara, Turkey. Electronic address: ancakar@yahoo.com.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Division of Haematology, Department of Internal Medicine, Ankara University, Turkey. Electronic address: mbeksac56@gmail.com.'}, {'ForeName': 'Mehmet Sinan', 'Initials': 'MS', 'LastName': 'Beksac', 'Affiliation': 'Division of Perinatology, Department of Obstetrics and Gynecology, Faculty of Medicine, Hacettepe University, Turkey. Electronic address: beksac@hacettepe.edu.tr.'}]",Journal of reproductive immunology,['10.1016/j.jri.2021.103425']
1839,34607196,"Neuroaspis PLP10™, a nutritional formula rich in omega-3 and omega-6 fatty acids with antioxidant vitamins including gamma-tocopherol in early Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","In the present study, we investigated whether Neuroaspis PLP10™, a well-designed intervention, rich in omega-3 (n-3) and omega-6 (n-6) polyunsaturated fatty acids (PUFAs) with specific antioxidant vitamins, may exert positive action in the improvement of Parkinson's disease symptoms and perhaps delay the progression of the disease when used as an adjuvant to the conventional treatment. Forty patients were randomized 1:1 to receive either 20 ml dose, once daily, of control (pure virgin olive oil) or Neuroaspis PLP 10™, a formula containing a mixture of omega-3 (810 mg Eicosapentaenoic acid and 4140 mg Docosahexaenoic acid) and omega-6 fatty acids (1800 mg gamma-Linolenic acid and 3150 mg Linoleic acid) (1:1 w/w), with 0.6 mg vitamin A, vitamin E (22 mg) plus pure gamma (γ)-tocopherol (760 mg), for a total of 30 months in a randomized double-blind, placebo-controlled trial. Participants completed assessments based on the Hoehn and Yahr Staging Scale of Parkinson's Disease (HY scale) and the Unified Parkinson's Disease Rating Scale (UPDRS) III. Overall, for this small sample size clinical trial, Neuroaspis PLP10™ supplementation as an adjuvant treatment for 30 months in PD patients significantly delayed disease progression according to UPDRS (p ≤ 0.05) Vs placebo.",2021,Participants completed assessments based on the Hoehn and Yahr Staging Scale of Parkinson's Disease (HY scale) and the Unified Parkinson's Disease Rating Scale (UPDRS) III.,"[""early Parkinson's disease"", 'Forty patients']","['control (pure virgin olive oil) or Neuroaspis PLP 10™, a formula containing a mixture of omega-3 (810\xa0mg Eicosapentaenoic acid and 4140', 'mg\xa0gamma-Linolenic acid and 3150', 'mg Linoleic acid', 'vitamin A, vitamin E (22\xa0mg) plus pure gamma (γ)-tocopherol', 'Neuroaspis PLP10™, a well-designed intervention, rich in omega-3 (n-3) and omega-6 (n-6) polyunsaturated fatty acids (PUFAs) with specific antioxidant vitamins', 'nutritional formula rich in omega-3 and omega-6 fatty acids with antioxidant vitamins', 'mg Docosahexaenoic acid) and omega-6 fatty acids', 'placebo']","['delayed disease progression', ""Hoehn and Yahr Staging Scale of Parkinson's Disease (HY scale) and the Unified Parkinson's Disease Rating Scale (UPDRS) III""]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0034266', 'cui_str': 'pyridoxal phosphate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017054', 'cui_str': 'Gamma tocopherol'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0133860', 'cui_str': 'Fatty Acids, Omega-6'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}]",40.0,0.839737,Participants completed assessments based on the Hoehn and Yahr Staging Scale of Parkinson's Disease (HY scale) and the Unified Parkinson's Disease Rating Scale (UPDRS) III.,"[{'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Pantzaris', 'Affiliation': 'Cyprus Institute of Neurology and Genetics, Nicosia, Cyprus; School of Molecular Medicine, Cyprus Institute of Neurology and Genetics, Cyprus; PALUPA Medical Ltd, Nicosia, Cyprus. Electronic address: pantzari@cing.ac.cy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loukaides', 'Affiliation': 'Cyprus Institute of Neurology and Genetics, Nicosia, Cyprus; PALUPA Medical Ltd, Nicosia, Cyprus.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Paraskevis', 'Affiliation': 'School of Medicine, European University Cyprus, Cyprus; Department of Hygiene Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Evangelia-Georgia', 'Initials': 'EG', 'LastName': 'Kostaki', 'Affiliation': 'Department of Hygiene Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Patrikios', 'Affiliation': 'School of Medicine, European University Cyprus, Cyprus; PALUPA Medical Ltd, Nicosia, Cyprus. Electronic address: i.patrikios@euc.ac.cy.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2021.106954']
1840,34611666,Covid-19 in the Phase 3 Trial of mRNA-1273 During the Delta-variant Surge.,"Background


Following emergency use authorization in December 2020, the Coronavirus Efficacy (COVE) trial was amended to an open-label phase, where participants were unblinded and those randomized to placebo were offered vaccination. Emergence of the delta variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been associated with increased incidences of coronavirus disease 2019 (Covid-19) among unvaccinated and vaccinated persons. This exploratory analysis evaluated the incidence and genetic sequences of Covid-19 cases in the ongoing COVE trial during the open-label phase, with a focus on July-August 2021, when delta-variants surged in the US.
Methods


Covid-19 cases were identified in participants initially randomized to mRNA-1273 (vaccinated from July-December 2020) and those initially randomized to the placebo (vaccinated December 2020-April 2021) who received at least one dose and were SARS-CoV-2-negative at baseline in the modified-intent-to-treat population were analyzed. Included were Covid-19 cases occurring after 26-Mar-2021 with positive RT-PCR results in nasopharyngeal samples (central lab test) and reported Covid-19 symptoms. Genetic sequencing of Covid-19 cases was also performed.
Results


There were 14,746 participants in the earlier mRNA-1273 (mRNA-1273e) group and 11,431 in the later placebo-mRNA1273 (mRNA-1273p) group. Covid-19 cases increased from the start of the open-label phase to July-August 2021. During July and August, 162 Covid-19 cases occurred in the mRNA-1273e group and 88 in the mRNA-1273p group. Of the cases sequenced, 144/149 [97%]) in the mRNA-1273 and 86/88 (99%) in the mRNA-1273p groups were attributed to delta. The incidence rate of Covid-19 was lower for the mRNA-1273p (49.0/1000 person-years) versus mRNA-1273e (77.1/1000 person-years) group [36.4% (95% CI 17.1%-51.5%) reduction]. There were fewer severe Covid-19 cases in the mRNA-1273p (6; 6.2/1000 person-years) than mRNA-1273e (13; 3.3/1000 person-years) [46.0% (95% CI -52.4%-83.2%) reduction]. Three Covid-19 related hospitalizations occurred with two resulting deaths in the mRNA-1273e group.
Conclusion


Incidence rates of Covid-19 and severe Covid-19 were lower during the months when delta was the dominant variant (July/August 2021) among COVE participants vaccinated more recently. Analysis of COVID-19 cases from the open-label phase of the COVE study is ongoing.",2021,The incidence rate of Covid-19 was lower for the mRNA-1273p (49.0/1000 person-years) versus mRNA-1273e (77.1/1000 person-years) group [36.4% (95% CI 17.1%-51.5%) reduction].,"['14,746 participants in the earlier mRNA-1273 (mRNA-1273e) group and 11,431 in the later placebo-mRNA1273 (mRNA-1273p) group']","['mRNA-1273e', 'placebo', 'mRNA-1273']","['severe Covid-19 cases', 'Incidence rates of Covid-19 and severe Covid-19', 'incidence rate of Covid-19']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",14746.0,0.122253,The incidence rate of Covid-19 was lower for the mRNA-1273p (49.0/1000 person-years) versus mRNA-1273e (77.1/1000 person-years) group [36.4% (95% CI 17.1%-51.5%) reduction].,"[{'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ''}, {'ForeName': 'Hana M', 'Initials': 'HM', 'LastName': 'El Sahly', 'Affiliation': ''}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Essink', 'Affiliation': ''}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Follmann', 'Affiliation': ''}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'August', 'Affiliation': ''}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Clouting', 'Affiliation': ''}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Fortier', 'Affiliation': ''}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Leav', 'Affiliation': ''}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Talarico', 'Affiliation': ''}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Girard', 'Affiliation': ''}, {'ForeName': 'Yamuna D', 'Initials': 'YD', 'LastName': 'Paila', 'Affiliation': ''}, {'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Tomassini', 'Affiliation': ''}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schödel', 'Affiliation': ''}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Pajon', 'Affiliation': ''}, {'ForeName': 'Honghong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': ''}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': ''}]",medRxiv : the preprint server for health sciences,['10.1101/2021.09.17.21263624']
1841,34618162,Dupilumab Provides Rapid and Sustained Clinically Meaningful Responses in Adults with Moderate-to-severe Atopic Dermatitis.,"Optimal management of atopic dermatitis requires a comprehensive assessment of response to treatment in order to inform therapeutic decisions. In a real-world setting, successful response to atopic dermatitis treatment is measured by sustained improvements in signs, symptoms, and quality of life. Post-hoc analyses of a 1-year, randomized, double-blinded, placebo- controlled trial (NCT02260986) of dupilumab with concomitant topical corticosteroids in 421 adults with moderate-to-severe atopic dermatitis (of whom 315/106 received placebo/dupilumab (of whom 315 received placebo and 106 received dupilumab) was performed to assess the proportion of responders to dupilumab through a multidimensional composite endpoint. At 6-months, 80.2% of dupilumab-treated vs 40.0% placebo patients (p < 0.0001) achieved improvement in signs (Eczema Area and Severity Index ≤ 7), symptoms (worst itch score ≤ 4), or quality of life (Dermatology Life Quality Index ≤5), representative of minimal/clear atopic dermatitis. All 3 endpoints, indicative of no/minimal atopic dermatitis, were achieved by 44.3% of dupilumab-treated vs 10.2% placebo patients (p < 0.0001) and sustained through 1 year. Dupilumab treatment provided sustained clinically meaningful improvement in signs, symptoms, and quality of life in adults with moderate-to-severe atopic dermatitis.",2021,"All 3 endpoints, indicative of no/minimal atopic dermatitis, were achieved by 44.3% of dupilumab-treated vs 10.2% placebo patients (p < 0.0001) and sustained through one year.","['Adults with Moderate-to-severe Atopic Dermatitis', 'adults with moderate-to-severe atopic dermatitis', '421 adults with moderate-to-severe atopic dermatitis (of whom 315/106 received']","['placebo', 'dupilumab with concomitant topical corticosteroid', 'placebo/dupilumab']","['indicative of no/minimal atopic dermatitis', 'signs (Eczema Area and Severity ≤\u20097), symptoms (worst itch score ≤\u20094) or quality of life (Dermatology Life Quality Index ≤5), representative of minimal/clear atopic dermatitis', 'signs, symptoms, and quality of life', 'signs, symptoms and quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}]",421.0,0.269103,"All 3 endpoints, indicative of no/minimal atopic dermatitis, were achieved by 44.3% of dupilumab-treated vs 10.2% placebo patients (p < 0.0001) and sustained through one year.","[{'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'George Washington University School of Medicine of Health Sciences, Ross Hall, 300 Eye Street NW, Washington 20037, DC, USA. JonathanISilverberg@gmail.com.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boguniewicz', 'Affiliation': ''}, {'ForeName': 'Marjolein S', 'Initials': 'MS', 'LastName': 'De Bruin-Weller', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ''}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kataoka', 'Affiliation': ''}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Bégo-Le-Bagousse', 'Affiliation': ''}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': ''}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': ''}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/actadv.v101.307']
1842,34617960,Effect of Topical Phenylephrine 2.5% on Episcleral Venous Pressure in Normal Human Eyes.,"Purpose


Phenylephrine has been shown to affect intraocular pressure (IOP) but the mechanism of action is poorly understood. However, its action as a vasoconstrictor suggests possible effects on episcleral venous pressure (EVP). In this study, we evaluated the effect of phenylephrine on EVP and IOP in healthy subjects.
Methods


Forty eyes of 20 subjects were included. Each subject received 3 drops of phenylephrine 2.5% in one eye at 1-minute intervals. The fellow eye served as control. Blood pressure, heart rate, and IOP and EVP of both eyes were measured at baseline, 15 minutes, and 60 minutes after instillation of phenylephrine. IOP was measured by pneumatonometry. EVP was assessed by using a computer-controlled episcleral venomanometer. Changes in IOP, EVP, blood pressure, and heart rate at 15 and 60 minutes were analyzed by paired t-tests.
Results


IOP increased 15 minutes after instillation of phenylephrine in both treated (P = 0.001) and control eyes (P = 0.01) and returned to baseline at 60 minutes. The change in IOP at 15 minutes was not significantly different between the 2 groups. EVP in treated eyes was unchanged at 15 minutes (P = 0.8) but decreased significantly at 60 minutes (P < 0.001). In control eyes, there was no change in EVP at any time (P > 0.6). There were no significant changes from baseline in systolic and diastolic blood pressure and heart rate after instillation of phenylephrine.
Conclusions


IOP elevation associated with topical phenylephrine is not caused by an increase in EVP in healthy subjects. Instead, EVP decreases with phenylephrine, but the mechanism remains to be determined.",2021,IOP increased 15 minutes after instillation of phenylephrine in both treated (P = 0.001) and control eyes (P = 0.01) and returned to baseline at 60 minutes.,"['Normal Human Eyes', 'Methods\n\n\nForty eyes of 20 subjects were included', 'healthy subjects']","['Topical Phenylephrine', 'topical phenylephrine', 'phenylephrine', 'Phenylephrine']","['episcleral venous pressure (EVP', 'IOP', 'Blood pressure, heart rate, and IOP and EVP of both eyes', 'EVP', 'change in IOP', 'systolic and diastolic blood pressure and heart rate', 'Episcleral Venous Pressure', 'EVP and IOP', 'IOP, EVP, blood pressure, and heart rate', 'intraocular pressure (IOP']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3212565', 'cui_str': 'Phenylephrine-containing product in cutaneous dose form'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C1827744', 'cui_str': 'Episcleral venous pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",20.0,0.0612308,IOP increased 15 minutes after instillation of phenylephrine in both treated (P = 0.001) and control eyes (P = 0.01) and returned to baseline at 60 minutes.,"[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota, United States.'}, {'ForeName': 'Jay W', 'Initials': 'JW', 'LastName': 'McLaren', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota, United States.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'Sit', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota, United States.'}]",Investigative ophthalmology & visual science,['10.1167/iovs.62.13.4']
1843,34617821,The impact of elevated body core temperature on critical power as determined by a 3-min all-out test.,"Critical power (CP) delineates the heavy and severe exercise intensity domains, and sustained work rates above CP result in an inexorable progression of oxygen uptake to a maximal value and, subsequently, the limit of exercise tolerance. The finite work capacity above CP, W', is defined by the curvature constant of the power-duration relationship. Heavy or severe exercise in a hot environment generates additional challenges related to the rise in body core temperature (T c ) that may impact CP and W'. The purpose of this study was to determine the effect of elevated T c  on CP and W'. CP and W' were estimated by end-test power (EP; mean of final 30 s) and work above end-test power (WEP), respectively, from 3-min ""all-out"" tests performed on a cycle ergometer. Volunteers ( n  = 8, 4 female) performed the 3-min tests during a familiarization visit and two experimental visits (thermoneutral vs. hot, randomized crossover design). Before experimental 3-min tests, the subjects were immersed in water (thermoneutral: 36°C for 30 min; hot: 40.5°C until T c  was ≥38.5°C). Mean T c  was significantly greater in the hot condition than in the thermoneutral condition (38.5 ± 0.0°C vs. 37.4 ± 0.2°C; means ± SD,  P  < 0.01). All 3-min tests were performed in an environmental chamber [thermoneutral: 18°C, 45% relative humidity (RH); hot: 38 °C, 40% RH]. EP was similar between thermoneutral (239 ± 57 W) and hot (234 ± 66 W;  P  = 0.55) conditions. WEP was similar between thermoneutral (10.9 ± 3.0 kJ) and hot conditions (9.3 ± 3.6;  P  = 0.19). These results suggest that elevated T c  has no significant impact on EP or WEP. NEW & NOTEWORTHY  The parameters of the power-duration relationship (critical power and W') estimated by a 3-min all-out test were not altered by elevated body core temperature as compared with a thermoneutral condition.",2021,EP was similar between Thermoneutral (239 ± 57W) and Hot (234 ± 66W; P = 0.55).,"['Volunteers (n = 8, 4 female']",['Heavy or severe exercise'],"['WEP', 'EP or WEP', 'Mean T c']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0330078,EP was similar between Thermoneutral (239 ± 57W) and Hot (234 ± 66W; P = 0.55).,"[{'ForeName': 'Brendan W', 'Initials': 'BW', 'LastName': 'Kaiser', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': ""Ka'eo K"", 'Initials': 'KK', 'LastName': 'Kruse', 'Affiliation': 'Department of Human Evolutionary Biology, Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Gibson', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Kelsey J', 'Initials': 'KJ', 'LastName': 'Santisteban', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Larson', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Brad W', 'Initials': 'BW', 'LastName': 'Wilkins', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Jones', 'Affiliation': ""Department of Sport and Health Sciences, University of Exeter, St. Luke's Campus, Exeter, United Kingdom.""}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Halliwill', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Minson', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00253.2021']
1844,34614209,Fatigue and endocrine symptoms among women with early breast cancer randomized to endocrine versus chemoendocrine therapy: Results from the TAILORx patient-reported outcomes substudy.,"BACKGROUND


TAILORx (Trial Assigning Individualized Options for Treatment) prospectively assessed fatigue and endocrine symptoms among women with early-stage hormone receptor-positive breast cancer and a midrange risk of recurrence who were randomized to endocrine therapy (E) or chemotherapy followed by endocrine therapy (CT+E).
METHODS


Participants completed the Functional Assessment of Chronic Illness Therapy-Fatigue, the Patient-Reported Outcomes Measurement Information System-Fatigue Short Form, and the Functional Assessment of Cancer Therapy-Endocrine Symptoms at the baseline and at 3, 6, 12, 24, and 36 months. Linear regression was used to model outcomes on baseline symptoms, treatment, and other factors.
RESULTS


Participants (n = 458) in both treatment arms reported greater fatigue and endocrine symptoms at early follow-up in comparison with the baseline. The magnitude of change in fatigue was significantly greater for the CT+E arm than the E arm at 3 and 6 months but not at 12, 24, or 36 months. The CT+E arm reported significantly greater changes in endocrine symptoms from the baseline to 3 months in comparison with the E arm; change scores were not significantly different at later time points. Endocrine symptom trajectories by treatment differed by menopausal status, with the effect larger and increasing for postmenopausal patients.
CONCLUSIONS


Adjuvant CT+E was associated with greater increases in fatigue and endocrine symptoms at early time points in comparison with E. These differences lessened over time, and this demonstrated early chemotherapy effects more than long-term ones. Treatment arm differences in endocrine symptoms were more evident in postmenopausal patients.
LAY SUMMARY


Participants in TAILORx (Trial Assigning Individualized Options for Treatment) with early-stage hormone receptor-positive breast cancer and an intermediate risk of recurrence were randomly assigned to endocrine or chemoendocrine therapy. Four hundred fifty-eight women reported fatigue and endocrine symptoms at the baseline and at 3, 6, 12, 24, and 36 months. Both groups reported greater symptoms at early follow-up versus the baseline. Increases in fatigue were greater for the chemoendocrine group than the endocrine group at 3 and 6 months but not later. The chemoendocrine group reported greater changes in endocrine symptoms in comparison with the endocrine group at 3 months but not later.",2021,"CONCLUSIONS


Adjuvant CT+E was associated with greater increases in fatigue and endocrine symptoms at early time points in comparison with E. These differences lessened over time, and this demonstrated early chemotherapy effects more than long-term ones.","['Participants in TAILORx (Trial Assigning Individualized Options for Treatment) with early-stage hormone receptor-positive breast cancer and an intermediate risk of recurrence', 'postmenopausal patients', 'women with early breast cancer', 'women with early-stage hormone receptor-positive breast cancer and a midrange risk of recurrence']","['endocrine or chemoendocrine therapy', 'chemoendocrine', 'endocrine', 'endocrine versus chemoendocrine therapy', 'endocrine therapy (E) or chemotherapy followed by endocrine therapy (CT+E', 'CT+E']","['fatigue and endocrine symptoms', 'Fatigue and endocrine symptoms', 'magnitude of change in fatigue', 'fatigue', 'Functional Assessment of Chronic Illness Therapy-Fatigue, the Patient-Reported Outcomes Measurement Information System-Fatigue Short Form, and the Functional Assessment of Cancer Therapy-Endocrine Symptoms', 'endocrine symptoms', 'Endocrine symptom trajectories']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",458.0,0.190351,"CONCLUSIONS


Adjuvant CT+E was associated with greater increases in fatigue and endocrine symptoms at early time points in comparison with E. These differences lessened over time, and this demonstrated early chemotherapy effects more than long-term ones.","[{'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Garcia', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, New York, New York.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Ilana F', 'Initials': 'IF', 'LastName': 'Gareen', 'Affiliation': 'Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'Juravinski Cancer Center at Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford Cancer Institute, Palo Alto, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston-Salem, North Carolina.'}]",Cancer,['10.1002/cncr.33939']
1845,34618889,Preoperative Paravertebral Block and Chronic Pain after Breast Cancer Surgery: A Double-blind Randomized Trial.,"BACKGROUND


The effectiveness of paravertebral block in preventing chronic pain after breast surgery remains controversial. The primary hypothesis of this study was that paravertebral block reduces the incidence of chronic pain 3 months after breast cancer surgery.
METHODS


In this prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, 380 women undergoing partial or complete mastectomy with or without lymph node dissection were randomized to receive preoperative paravertebral block with either 0.35 ml/kg 0.75% ropivacaine (paravertebral group) or saline (control group). Systemic multimodal analgesia was administered in both groups. The primary endpoint was the incidence of chronic pain with a visual analogue scale (VAS) score greater than or equal to 3 out of 10, 3 months after surgery. The secondary outcomes were acute pain, analgesic consumption, nausea and vomiting, chronic pain at 6 and 12 months, neuropathic pain, pain interference, anxiety, and depression.
RESULTS


Overall, 178 patients received ropivacaine, and 174 received saline. At 3 months, chronic pain was reported in 93 of 178 (52.2%) and 83 of 174 (47.7%) patients in the paravertebral and control groups, respectively (odds ratio, 1.20 [95% CI, 0.79 to 1.82], P = 0.394). At 6 and 12 months, chronic pain occurred in 104 of 178 (58.4%) versus 79 of 174 (45.4%) and 105 of 178 (59.0%) versus 93 of 174 (53.4%) patients in the paravertebral and control groups, respectively. Greater acute postoperative pain was observed in the control group 0 to 2 h (area under the receiver operating characteristics curve at rest, 4.3 ± 2.8 vs. 2.9 ± 2.8 VAS score units × hours, P < 0.001) and when maximal in this interval (3.8 ± 2.1 vs. 2.5 ± 2.5, P < 0.001) but not during any other interval. Postoperative morphine use was 73% less in the paravertebral group (odds ratio, 0.272 [95% CI, 0.171 to 0.429]; P < 0.001).
CONCLUSIONS


Paravertebral block did not reduce the incidence of chronic pain after breast surgery. Paravertebral block did result in less immediate postoperative pain, but there were no other significant differences in postoperative outcomes.
EDITOR’S PERSPECTIVE


",2021,"At 6 and 12 months, chronic pain occurred in 104 of 178 (58.4%) versus 79 of 174 (45.4%) and 105 of 178 (59.0%) versus 93 of 174 (53.4%) patients in the paravertebral and control groups, respectively.","['178 patients received', '380 women undergoing partial or complete mastectomy with or without lymph node dissection', 'after Breast Cancer Surgery']","['saline', 'ropivacaine', 'paravertebral block', 'preoperative paravertebral block with either 0.35 ml/kg 0.75% ropivacaine (paravertebral group) or saline', 'placebo']","['incidence of chronic pain with a visual analogue scale (VAS) score', 'acute pain, analgesic consumption, nausea and vomiting, chronic pain at 6 and 12 months, neuropathic pain, pain interference, anxiety, and depression', 'chronic pain', 'Greater acute postoperative pain', 'postoperative outcomes', 'immediate postoperative pain', 'Preoperative Paravertebral Block and Chronic Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",380.0,0.88581,"At 6 and 12 months, chronic pain occurred in 104 of 178 (58.4%) versus 79 of 174 (45.4%) and 105 of 178 (59.0%) versus 93 of 174 (53.4%) patients in the paravertebral and control groups, respectively.","[{'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Albi-Feldzer', 'Affiliation': 'Department of Anesthesiology, Institut Curie, PSL Research University, Saint-Cloud, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Dureau', 'Affiliation': 'the Biometry Unit, Institut Curie, Paris Sciences & Lettres University, Paris, France.'}, {'ForeName': 'Abdelmalek', 'Initials': 'A', 'LastName': 'Ghimouz', 'Affiliation': 'the Department of Anesthesiology, Institut Curie, Paris Sciences & Lettres University, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Raft', 'Affiliation': 'the Department of Anesthesiology, Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Soubirou', 'Affiliation': 'the Department of Anesthesiology, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Gayraud', 'Affiliation': 'the Department of Anesthesiology, Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jayr', 'Affiliation': 'Department of Anesthesiology, Institut Curie, PSL Research University, Saint-Cloud, France.'}]",Anesthesiology,['10.1097/ALN.0000000000003989']
1846,34618825,Impact of a care bundle for patients with blunt chest injury (ChIP): A multicentre controlled implementation evaluation.,"BACKGROUND


Blunt chest injury leads to significant morbidity and mortality. The aim of this study was to evaluate the effect of a multidisciplinary chest injury care bundle (ChIP) on patient and health service outcomes. ChIP provides guidance in three key pillars of care for blunt chest injury-respiratory support, analgesia and complication prevention. ChIP was implemented using a multi-faceted implementation plan developed using the Behaviour Change Wheel.
METHODS


This controlled pre-and post-test study (two intervention and two non-intervention sites) was conducted from July 2015 to June 2019. The primary outcome measures were unplanned Intensive Care Unit (ICU) admissions, non-invasive ventilation use and mortality.
RESULTS


There were 1790 patients included. The intervention sites had a 58% decrease in non-invasive ventilation use in the post- period compared to the pre-period (95% CI 0.18-0.96). ChIP was associated with 90% decreased odds of unplanned ICU admissions (95% CI 0.04-0.29) at the intervention sites compared to the control groups in the post- period. There was no significant change in mortality. There were higher odds of health service team reviews (surgical OR 6.6 (95% CI 4.61-9.45), physiotherapy OR 2.17 (95% CI 1.52-3.11), ICU doctor OR 6.13 (95% CI 3.94-9.55), ICU liaison OR 55.75 (95% CI 17.48-177.75), pain team OR 8.15 (95% CI 5.52 --12.03), analgesia (e.g. patient controlled analgesia OR 2.6 (95% CI 1.64-3.94) and regional analgesia OR 8.8 (95% CI 3.39-22.79), incentive spirometry OR 8.3 (95% CI 4.49-15.37) and, high flow nasal oxygen OR 22.1 (95% CI 12.43-39.2) in the intervention group compared to the control group in the post- period.
CONCLUSION


The implementation of a chest injury care bundle using behaviour change theory was associated with a sustained improvement in evidence-based practice resulting in reduced unplanned ICU admissions and non-invasive ventilation requirement.
TRIAL REGISTRATION


ANZCTR: ACTRN12618001548224, approved 17/09/2018.",2021,"The implementation of a chest injury care bundle using behaviour change theory was associated with a sustained improvement in evidence-based practice resulting in reduced unplanned ICU admissions and non-invasive ventilation requirement.
","['patients with blunt chest injury (ChIP', '1790 patients included']","['multidisciplinary chest injury care bundle (ChIP', 'ANZCTR']","['mortality', 'analgesia', 'pain team OR', 'unplanned Intensive Care Unit (ICU) admissions, non-invasive ventilation use and mortality', 'high flow nasal oxygen OR', 'non-invasive ventilation', 'regional analgesia OR', 'incentive spirometry OR', 'unplanned ICU admissions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0039980', 'cui_str': 'Chest injury'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039980', 'cui_str': 'Chest injury'}, {'cui': 'C3658308', 'cui_str': 'Care Bundles'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}]",,0.0653723,"The implementation of a chest injury care bundle using behaviour change theory was associated with a sustained improvement in evidence-based practice resulting in reduced unplanned ICU admissions and non-invasive ventilation requirement.
","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Curtis', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kourouche', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Asha', 'Affiliation': 'Emergency Department, St George Hospital, Kogarah, NSW, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Considine', 'Affiliation': 'School of Nursing and Midwifery and Centre for Quality and Patient Safety Experience in the Institute for Health Transformation, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Fry', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Network Sydney, St Vincent's Hospital Melbourne, Fitzroy, Australia.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mitchell', 'Affiliation': 'Australian Institute of Health Innovation, Faculty of Medicine, Health and Human Sciences, Macquarie University, Macquarie Park, NSW, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Munroe', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Ramon Z', 'Initials': 'RZ', 'LastName': 'Shaban', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Alfa', 'Initials': 'A', 'LastName': ""D'Amato"", 'Affiliation': 'NSW Activity Based Funding Taskforce, NSW Ministry of Health, Sydney, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Skinner', 'Affiliation': 'Emergency Department, Hornsby Ku-ring-ai Hospital, Hornsby, NSW, Australia.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Wiseman', 'Affiliation': 'Emergency Services, Canterbury Hospital, Campsie, NSW, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Buckley', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, University of Sydney, Camperdown, NSW, Australia.'}]",PloS one,['10.1371/journal.pone.0256027']
1847,34622430,Emotional and Attentional Bias in Fibromyalgia: A Pilot ERP Study of the Dot-Probe Task.,"INTRODUCTION


The present research investigates the neural correlates of attentional bias in fibromyalgia (FM) with a dot-probe task performed during an electroencephalogram (EEG) recording.
METHODS


For this purpose, 30 female participants were recruited, divided into two groups: a group of patients with FM (FM, n = 15, M age  = 51.87) and a healthy control group (HC) (HC, n = 15, M age  = 46.13).
RESULTS


The results did not show behavioral differences between groups, but the EEG results showed that healthy controls had larger P300 amplitudes than patients with FM. Regarding late positive potentials (LPP), we found that patients with FM had larger amplitudes than healthy controls in a later time window.
CONCLUSION


In summary, while the P300 results suggest that patients allocate less attentional resources to the task, the increased amplitudes of their LPP suggest augmented emotional processing of the target stimuli. Altogether, our results seem to support the thesis of generalized attentional deficits in FM.",2021,"The results did not show behavioral differences between groups, but the EEG results showed that healthy controls had larger P300 amplitudes than patients with FM.","['Fibromyalgia', '30 female participants were recruited, divided into two groups: a group of patients with FM (FM, n\u2009=\u200915, M age \u2009=\u200951.87) and a healthy control group (HC) (HC, n\u2009=\u200915, M age \u2009=\u200946.13']",[],"['generalized attentional deficits', 'Emotional and Attentional Bias', 'larger P300 amplitudes']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}]",30.0,0.0428402,"The results did not show behavioral differences between groups, but the EEG results showed that healthy controls had larger P300 amplitudes than patients with FM.","[{'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Cardoso', 'Affiliation': 'Laboratory of Neuropsychophysiology, Faculty of Psychology and Education Sciences, University of Porto, Rua Alfredo Allen, 4200-135, Porto, Portugal. carmensnunes@utad.pt.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Fernandes', 'Affiliation': 'Laboratory of Neuropsychophysiology, Faculty of Psychology and Education Sciences, University of Porto, Rua Alfredo Allen, 4200-135, Porto, Portugal.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Barbosa', 'Affiliation': 'Laboratory of Neuropsychophysiology, Faculty of Psychology and Education Sciences, University of Porto, Rua Alfredo Allen, 4200-135, Porto, Portugal.'}]",Neurology and therapy,['10.1007/s40120-021-00287-8']
1848,34624138,Efficacy of myo-inositol and d-chiro-inositol combination on menstrual cycle regulation and improving insulin resistance in young women with polycystic ovary syndrome: A randomized open-label study.,"OBJECTIVE


To compare the effect of myo-inositol and d-chiro-inositol in combination (MI + DCI) with combined hormonal contraceptive (CHC) on menstrual cycle regulation in young Indian women with polycystic ovary syndrome (PCOS).
METHODS


Seventy young women with PCOS aged 15-24 years with delayed cycles were randomized into two groups and were treated for 6 months with MI + DCI (550 + 150 mg, 3.6:1 ratio) twice a day and CHC (ethinyl estradiol 20 µg + drospirenone 3 mg) once a day.
RESULTS


Spontaneous menses resumed in 28 (84.85%) young women on MI + DCI, compared with withdrawal bleeding in 34 (100%) on CHC. The mean cycle length reduced with both MI + DCI (124.54 ± 8.08 to 57.75 ± 3.00 days, P < 0.001) and CHC (105.88 ± 7.96 to 30.53 ± 2.95 days, P < 0.001). Regular menstrual cycles were established in 9 (27.27%) young women with MI + DCI (P = 0.001) and 30 (88.23%) with CHC (P < 0.001). Three months after stopping the treatment, 24 young women (85.71%) on MI + DCI and 25 (73.53%) on CHC continued to have spontaneous cycles. Anti-Müllerian hormone decreased with both the drugs (P = 0.001), whereas luteinizing hormone (P = 0.001) and testosterone (P = 0.04) decreased with CHC and homeostatic model assessment of insulin resistance (P < 0.001) with MI + DCI.
CONCLUSION


Myo-inositol and d-chiro-inositol in combination (3.6:1 ratio) are effective in regularizing menstrual cycles and improving insulin resistance.
TRIAL REGISTRATION


Clinical Trials Registry of India (CTRI/2018/03/012643). http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=20969&EncHid=&userName=myo-inositol.",2021,Regular menstrual cycles were established in 27.27% of girls with MI+DCI (P=0.001) and 88.23% with CHC (P<0.001).,"['young girls with PCOS', 'Seventy PCOS girls aged 15-24 years with delayed cycles', 'young Indian girls with PCOS']","['Myo-inositol and D-chiro-inositol combination', 'Myo-inositol-D-chiro-inositol combination (MI+DCI) with combined hormonal contraceptive (CHC', 'Myo-inositol-D-chiro-inositol combination (550 mg + 150 mg, 3.6:1 ratio) twice a day and CHC (Ethinyl estradiol 20 mcg + drospirenone']","['withdrawal bleeding', 'AMH', 'insulin resistance', 'Regular menstrual cycles', 'mean cycle length', 'CHC and HOMA-IR', 'menstrual cycle regulation']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}]","[{'cui': 'C0152010', 'cui_str': 'Withdrawal bleeding'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",70.0,0.0928246,Regular menstrual cycles were established in 27.27% of girls with MI+DCI (P=0.001) and 88.23% with CHC (P<0.001).,"[{'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Kachhawa', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Krithika V', 'Initials': 'KV', 'LastName': 'Senthil Kumar', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vidushi', 'Initials': 'V', 'LastName': 'Kulshrestha', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Khadgawat', 'Affiliation': 'Department of Endocrinology & Metabolism, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Mahey', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhatla', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13971']
1849,34627030,The effectiveness of the virtual patient-based social learning approach in undergraduate nursing education: A quasi-experimental study.,"BACKGROUND


In nursing education, knowledge and competence in conducting physical assessments are crucial. Therefore, physical assessment knowledge has become a fundamental and essential education program for nursing students. However, most of the current nursing courses are taught via a didactic teaching approach, making it difficult for students to think deeply about relevant issues due to the lack of interaction and context. This may, in turn, have an impact on learning effectiveness and clinical judgment.
OBJECTIVE


A virtual patient (VP)-based social learning approach is proposed to enhance nursing students' performance and clinical judgment in education programs.
DESIGN


A quasi-experiment method was adopted to evaluate the effectiveness of the proposed approach.
PARTICIPANTS


A total of 40 senior nursing students participated in the study (VP-based social learning approach group = 20, control group = 20).
METHODS


The study involved a pre- and post-test to examine students' learning achievements, self-efficacy, and communication skills. The experimental group adopted the VP-based learning approach, while the control group adopted the conventional didactic learning approach. ANCOVA was employed to compare the performances of the two groups.
RESULTS


The experimental results indicate that using a VP for learning can enhance students' learning achievements, self-efficacy, and communication skills. In addition, based on the analysis of the results, students generally believed that learning with a VP makes learning more enjoyable.
CONCLUSION


The VP-based social learning approach would be an effective strategy to train nursing students who have limited opportunities to experience real clinical situations, in particular during the COVID-19 pandemic.",2021,"The experimental results indicate that using a VP for learning can enhance students' learning achievements, self-efficacy, and communication skills.","['A total of 40 senior nursing students participated in the', 'undergraduate nursing education']","['virtual patient-based social learning approach', 'virtual patient (VP)-based social learning approach', 'VP-based learning approach, while the control group adopted the conventional didactic learning approach', 'study (VP-based social learning approach group\xa0=\xa020, control group\xa0=\xa020']","[""students' learning achievements, self-efficacy, and communication skills""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0013638', 'cui_str': 'Baccalaureate Nursing Education'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679082', 'cui_str': 'Social Learning'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",40.0,0.0146723,"The experimental results indicate that using a VP for learning can enhance students' learning achievements, self-efficacy, and communication skills.","[{'ForeName': 'Gwo-Jen', 'Initials': 'GJ', 'LastName': 'Hwang', 'Affiliation': 'Graduate Institute of Digital Learning and Education, National Taiwan University of Science and Technology, Taiwan. Electronic address: gjhwang.academic@gmail.com.'}, {'ForeName': 'Ching-Yi', 'Initials': 'CY', 'LastName': 'Chang', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan. Electronic address: frinng.cyc@gmail.com.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Academic Center for Computing and Media Studies and the Graduate School of Informatics, Kyoto University, Japan. Electronic address: hiroaki.ogata@gmail.com.'}]",Nurse education today,['10.1016/j.nedt.2021.105164']
1850,34629244,Rigid Ring Versus Flexible Band for Tricuspid Valve Repair in Patients Scheduled for Mitral Valve Surgery: A Prospective Randomised Study.,"BACKGROUND


Tricuspid valve repair for functional regurgitation is effectively performed with different annuloplasty devices. However, it remains unclear whether there are advantages associated with rigid rings compared to flexible bands. This prospective randomised study aimed to compare results of using a flexible band ring versus a rigid ring for functional tricuspid regurgitation in patients undergoing mitral valve surgery.
METHODS


A single-centre randomised study was designed to allocate patients with functional tricuspid regurgitation undergoing mitral valve surgery to be treated with a flexible band or rigid ring. These patients were analysed by echocardiographic follow-up. The primary outcome was freedom from recurrent tricuspid regurgitation at 12-months follow-up. Secondary outcomes were 30-day mortality, survival, freedom from tricuspid valve reoperation, right ventricular reverse remodelling, and rate of major adverse events.
RESULTS


A total of 308 patients were allocated to receive concomitant tricuspid valve annuloplasty with the flexible band or rigid ring. There was no between-group difference in freedom from recurrent tricuspid regurgitation: 97.3% in Rigid group (95% CI, 93.0-98.8) and 96.2% in the Flexible group (95% CI, 92.0-98.5) at 12-months follow-up (log-rank, p=0.261). Early mortality, survival, freedom from tricuspid valve reoperation, and global right ventricle systolic function were also comparable in both groups of patients. However, the flexible band had advantage in restoring regional right ventricle function (Doppler-derived systolic velocities of the annulus [S], tricuspid annular plane systolic excursion) at 12-months follow-up.
CONCLUSION


Both the rigid ring and flexible band offered acceptable outcomes for functional tricuspid regurgitation correction without significant differences, as assessed at 12-months follow-up.",2021,"Both the rigid ring and flexible band offered acceptable outcomes for functional tricuspid regurgitation correction without significant differences, as assessed at 12-months follow-up.","['Patients Scheduled for Mitral Valve Surgery', '308 patients', 'patients undergoing mitral valve surgery', 'patients with functional tricuspid regurgitation undergoing mitral valve surgery to be treated with a']","['flexible band ring versus a rigid ring', 'Rigid Ring Versus Flexible Band for Tricuspid Valve Repair', 'concomitant tricuspid valve annuloplasty with the flexible band or rigid ring', 'flexible band or rigid ring']","['30-day mortality, survival, freedom from tricuspid valve reoperation, right ventricular reverse remodelling, and rate of major adverse events', 'restoring regional right ventricle function (Doppler-derived systolic velocities of the annulus [S], tricuspid annular plane systolic excursion', 'freedom from recurrent tricuspid regurgitation', 'Early mortality, survival, freedom from tricuspid valve reoperation, and global right ventricle systolic function']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340392', 'cui_str': 'Functional tricuspid regurgitation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0396899', 'cui_str': 'Repair of tricuspid valve'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0396902', 'cui_str': 'Annuloplasty of tricuspid valve'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0040960', 'cui_str': 'Tricuspid valve structure'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C3888926', 'cui_str': 'Tricuspid annular plane systolic excursion'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",308.0,0.0509351,"Both the rigid ring and flexible band offered acceptable outcomes for functional tricuspid regurgitation correction without significant differences, as assessed at 12-months follow-up.","[{'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Bogachev-Prokophiev', 'Affiliation': 'Heart Valves Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Michail A', 'Initials': 'MA', 'LastName': 'Ovcharov', 'Affiliation': 'Heart Valves Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation. Electronic address: mihail.ovcharoff@gmail.com.'}, {'ForeName': 'Andrey V', 'Initials': 'AV', 'LastName': 'Sapegin', 'Affiliation': 'Heart Valves Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Sergey O', 'Initials': 'SO', 'LastName': 'Lavinykov', 'Affiliation': 'Heart Valves Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Dmitriy A', 'Initials': 'DA', 'LastName': 'Astapov', 'Affiliation': 'Heart Valves Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Sergey M', 'Initials': 'SM', 'LastName': 'Ivanzov', 'Affiliation': 'Heart Valves Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Ravil M', 'Initials': 'RM', 'LastName': 'Sharifulin', 'Affiliation': 'Heart Valves Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Afanasyev', 'Affiliation': 'Heart Valves Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Igor I', 'Initials': 'II', 'LastName': 'Demin', 'Affiliation': 'Heart Valves Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Sergey I', 'Initials': 'SI', 'LastName': 'Zeleznev', 'Affiliation': 'Heart Valves Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}]","Heart, lung & circulation",['10.1016/j.hlc.2021.08.009']
1851,34634640,Intranasal as needed naloxone in the treatment of gambling disorder: A randomised controlled trial.,"BACKGROUND


Gambling disorder (GD) is a global phenomenon affecting millions of people. GD can result in severe social and financial difficulties and efficacious treatments are warranted. Psychosocial treatments form the basis of treatment. Opioid antagonists (OAs) have however shown promise in previous studies. In a recent imaging study intranasal naloxone was found to rapidly and fully occupy brain μ-opioid receptors. This trial investigates the effect and safety of as needed naloxone in the treatment of gambling disorder.
METHODS


This was a 12-week double blind, randomised control trial comparing intranasal naloxone to placebo. The primary endpoint was gambling urge measured by the Gambling symptom Assessment Scale (G-SAS). Secondary outcome measures were gambling severity measures (PGSI) as well as quality of life (WHO:EUROHIS-8), alcohol consumption (AUDIT), depression (MARDS) and internet use (IDS-9SF). In addition, safety of treatment was assessed. Both treatment groups received psychosocial support.
RESULTS


126 participants were randomised to treatment groups in a 1:1 ratio. 106 patients completed the study. Gambling urge (GSAS) and other gambling related measured improved in both groups, but no statistically significant difference could be found. Intranasal naloxone was well tolerated, no subjects discontinued the study due to adverse events. No serious adverse drug reactions were observed.
CONCLUSIONS


This study found no difference between the as-needed administration of intranasal naloxone and placebo in reducing gambling urge in persons with GD. Intranasal naloxone was safe and well tolerated.",2021,"Gambling urge (GSAS) and other gambling related measured improved in both groups, but no statistically significant difference could be found.","['126 participants', '106 patients completed the study', 'persons with GD', 'gambling disorder']","['intranasal naloxone and placebo', 'psychosocial support', 'Opioid antagonists (OAs', 'intranasal naloxone', 'Intranasal naloxone', 'naloxone', 'placebo']","['safe and well tolerated', 'gambling severity measures (PGSI) as well as quality of life (WHO:EUROHIS-8), alcohol consumption (AUDIT), depression (MARDS) and internet use (IDS-9SF', 'gambling urge measured by the Gambling symptom Assessment Scale (G-SAS', 'gambling urge', 'Gambling urge (GSAS', 'serious adverse drug reactions']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030662', 'cui_str': 'Compulsive gambling'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}]","[{'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3711321', 'cui_str': '68Ga-labelled DTPA galactosyl human serum albumin'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",126.0,0.182011,"Gambling urge (GSAS) and other gambling related measured improved in both groups, but no statistically significant difference could be found.","[{'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Alho', 'Affiliation': 'University of Helsinki, Department of Medicine, Helsinki, Finland; Finnish Institute for Health and Welfare, Health and Well-Being Promotion Unit, Finland. Electronic address: hannu.alho@thl.fi.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Mäkelä', 'Affiliation': 'University of Helsinki, Department of Medicine, Helsinki, Finland. Electronic address: niklas.makela@helsinki.fi.'}, {'ForeName': 'Jarkko', 'Initials': 'J', 'LastName': 'Isotalo', 'Affiliation': 'University of Tampere, Tampereen Yliopisto, Finland. Electronic address: jarkko.isotalo@tuni.fi.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Toivonen', 'Affiliation': 'University of Tampere, Tampereen Yliopisto, Finland. Electronic address: lilianne.toivonen@tuni.fi.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Ollikainen', 'Affiliation': 'Tampere University, Computing Sciences, Finland. Electronic address: Jyrki.ollikainen@tuni.fi.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Castrén', 'Affiliation': 'University of Helsinki, Department of Medicine, Helsinki, Finland; Finnish Institute for Health and Welfare, Health and Well-Being Promotion Unit, Finland; University of Turku, Social Sciences\xa0Department of Psychology and Speech-Language Pathology, Turku, Finland. Electronic address: sari.castren@thl.fi.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.107127']
1852,34634534,Follow-up study of pulmonary sequelae in discharged COVID-19 patients with diabetes or secondary hyperglycemia.,"PURPOSE


To determine chest CT changes 6 months and 12 months after the onset of coronavirus disease 2019 (COVID-19) in patients with diabetes or hyperglycemia and the risk factors for these residual lung abnormalities.
METHODS


In total, 141 COVID-19 patients were assigned to group 1 (diabetes), group 2 (secondary hyperglycemia) or group 3 (controls). Initial and six- and twelve-month follow-up computed tomography (CT) scans were performed 16 days, 175 days and 351 days after symptom onset, respectively. CT findings and clinical and peak laboratory parameters were collected and compared. Univariable and multivariable logistic regression analyses were performed to identify the independent predictors for the presence of residual lung abnormalities at the 6-month follow-up exam. Seven variables (age; the presence of acute respiratory distress syndrome; the duration of hospitalization; the peak levels of lactate dehydrogenase (LDH) and C-reactive protein; and the initial total CT score) were chosen in the final multivariable models.
RESULTS


At the six-month follow-up, abnormalities were still observed on chest CT in 77/141 (54.6%) patients. Reticular patterns (40/141, 28.4%) and ground-glass opacities (GGOs) (29/141, 20.6%) were the most common CT abnormalities on the follow-up CT scans. Patients in Groups 1 and 2 had significantly higher incidences of residual lung abnormalities than those in Group 3 (65.4% and 58.3%, respectively vs. 36.6%; p < 0.05). Twelve months after disease onset, the chest CT changes persisted in 13/25 (52.0%) patients. A duration of hospitalization > 20 days (OR: 5.630, 95% CI: 1.394-22.744, p = 0.015), an LDH level ≥ 317 U/L (OR: 7.020, 95% CI: 1.032-47.743, p = 0.046) and a total CT score > 15 (OR: 9.919, 95% CI: 1.378-71.415, p = 0.023) were independent predictors of residual pulmonary abnormalities in patients with diabetes or secondary hyperglycemia.
CONCLUSIONS


A considerable proportion of surviving COVID-19 patients with diabetes or secondary hyperglycemia had residual pulmonary abnormalities six months after disease onset, and we found evidence of persistent chest CT changes at the one-year follow-up. Residual lung abnormalities were associated with longer hospital stays, higher peak LDH levels and higher initial total CT scores.",2021,"Reticular patterns (40/141, 28.4%) and ground-glass opacities (GGOs) (29/141, 20.6%) were the most common CT abnormalities on the follow-up CT scans.","['discharged COVID-19 patients with diabetes or secondary hyperglycemia', '141 COVID-19 patients', 'patients with diabetes or secondary hyperglycemia', 'patients with diabetes or hyperglycemia and the risk factors for these residual lung abnormalities']",['Initial and six- and twelve-month follow-up computed tomography (CT) scans'],"['Residual lung abnormalities', 'ground-glass opacities (GGOs', 'CT findings and clinical and peak laboratory parameters', 'total CT score', 'chest CT changes', 'residual lung abnormalities', 'longer hospital stays, higher peak LDH levels and higher initial total CT scores', 'duration of hospitalization; the peak levels of lactate dehydrogenase (LDH) and C-reactive protein; and the initial total CT score']","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",141.0,0.08584,"Reticular patterns (40/141, 28.4%) and ground-glass opacities (GGOs) (29/141, 20.6%) were the most common CT abnormalities on the follow-up CT scans.","[{'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.'}, {'ForeName': 'Osamah', 'Initials': 'O', 'LastName': 'Alwalid', 'Affiliation': 'Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': 'Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China.'}, {'ForeName': 'Yukun', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China.'}, {'ForeName': 'Guozhu', 'Initials': 'G', 'LastName': 'Shao', 'Affiliation': 'Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China.'}, {'ForeName': 'Yangqing', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Radiology, Wuhan Jinyintan Hospital, No.1 Yintan Road, Dongxihu District, Wuhan 430022, China. Electronic address: 1024932023@qq.com.'}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430077, China. Electronic address: 1993ly0538@hust.edu.cn.'}, {'ForeName': 'Heshui', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China. Electronic address: heshuishi@hust.edu.cn.'}]",European journal of radiology,['10.1016/j.ejrad.2021.109997']
1853,34617916,Impact of a Mobile App on Paramedics' Perceived and Physiologic Stress Response During Simulated Prehospital Pediatric Cardiopulmonary Resuscitation: Study Nested Within a Multicenter Randomized Controlled Trial.,"BACKGROUND


Out-of-hospital cardiac arrests (OHCAs) are stressful, high-stake events that are associated with low survival rates. Acute stress experienced in this situation is associated with lower cardiopulmonary resuscitation performance in calculating drug dosages by emergency medical services. Children are particularly vulnerable to such errors. To date, no app has been validated to specifically support emergency drug preparation by paramedics through reducing the stress level of this procedure and medication errors.
OBJECTIVE


This study aims to determine the effectiveness of an evidence-based mobile app compared with that of the conventional preparation methods in reducing acute stress in paramedics at the psychological and physiological levels while safely preparing emergency drugs during simulated pediatric OHCA scenarios.
METHODS


In a parent, multicenter, randomized controlled trial of 14 emergency medical services, perceived and physiologic stress of advanced paramedics with drug preparation autonomy was assessed during a 20-minute, standardized, fully video-recorded, and highly realistic pediatric OHCA scenario in an 18-month-old child. The primary outcome was participants' self-reported psychological stress perceived during sequential preparations of 4 intravenous emergency drugs (epinephrine, midazolam, 10% dextrose, and sodium bicarbonate) with the support of the PedAMINES (Pediatric Accurate Medication in Emergency Situations) app designed to help pediatric drug preparation (intervention) or conventional methods (control). The State-Trait Anxiety Inventory and Visual Analog Scale questionnaires were used to measure perceived stress. The secondary outcome was physiologic stress, measured by a single continuous measurement of the participants' heart rate with optical photoplethysmography.
RESULTS


From September 3, 2019, to January 21, 2020, 150 advanced paramedics underwent randomization. A total of 74 participants were assigned to the mobile app (intervention group), and 76 did not use the app (control group). A total of 600 drug doses were prepared. Higher State-Trait Anxiety Inventory-perceived stress increase from baseline was observed during the scenario using the conventional methods (mean 35.4, SD 8.2 to mean 49.8, SD 13.2; a 41.3%, 35.0 increase) than when using the app (mean 36.1, SD 8.1 to mean 39.0, SD 8.4; a 12.3%, 29.0 increase). This revealed a 30.1% (95% CI 20.5%-39.8%; P<.001) lower relative change in stress response in participants who used the app. On the Visual Analog Scale questionnaire, participants in the control group reported a higher increase in stress at the peak of the scenario (mean 7.1, SD 1.8 vs mean 6.4, SD 1.9; difference: -0.8, 95% CI -1.3 to -0.2; P=.005). Increase in heart rate during the scenario and over the 4 drugs was not different between the 2 groups.
CONCLUSIONS


Compared with the conventional method, dedicated mobile apps can reduce acute perceived stress during the preparation of emergency drugs in the prehospital setting during critical situations. These findings can help advance the development and evaluation of mobile apps for OHCA management and should be encouraged.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03921346; https://clinicaltrials.gov/ct2/show/NCT03921346.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s13063-019-3726-4.",2021,"Compared with the conventional method, dedicated mobile apps can reduce acute perceived stress during the preparation of emergency drugs in the prehospital setting during critical situations.","['74 participants were assigned to the mobile app (intervention group), and 76 did not use the app (control group', 'From September 3, 2019, to January 21, 2020, 150 advanced paramedics underwent randomization', '14 emergency medical services, perceived and physiologic stress of advanced paramedics with drug preparation autonomy', 'paramedics at the psychological and physiological levels while safely preparing emergency drugs during simulated pediatric OHCA scenarios', 'Simulated Prehospital Pediatric Cardiopulmonary Resuscitation']","['epinephrine, midazolam, 10% dextrose, and sodium bicarbonate', 'Mobile App']","['stress response', 'heart rate', ""physiologic stress, measured by a single continuous measurement of the participants' heart rate with optical photoplethysmography"", 'cardiopulmonary resuscitation performance', ' self-reported psychological stress', 'Higher State-Trait Anxiety Inventory-perceived stress increase', 'acute stress', 'State-Trait Anxiety Inventory and Visual Analog Scale questionnaires', ""Paramedics' Perceived and Physiologic Stress Response"", 'Visual Analog Scale questionnaire', 'stress at the peak of the scenario']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0013164', 'cui_str': 'Drug Preparation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",74.0,0.281681,"Compared with the conventional method, dedicated mobile apps can reduce acute perceived stress during the preparation of emergency drugs in the prehospital setting during critical situations.","[{'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Lacour', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Bloudeau', 'Affiliation': 'A.C.E. Geneva Ambulances SA, Geneva, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Combescure', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haddad', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Hugon', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Suppan', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Rodieux', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lovis', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Gervaix', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Ehrler', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Manzano', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Johan N', 'Initials': 'JN', 'LastName': 'Siebert', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""See Authors' Contributions, .""}]",JMIR mHealth and uHealth,['10.2196/31748']
1854,34617915,mHealth Messaging to Motivate Quitline Use and Quitting: Protocol for a Community-Based Randomized Controlled Trial in Rural Vietnam.,"BACKGROUND


Tobacco kills more than 8 million people each year, mostly in low- and middle-income countries. In Vietnam, 1 in every 2 male adults smokes tobacco. Vietnam has set up telephone Quitline counseling that is available to all smokers, but it is underused. We previously developed an automated and effective motivational text messaging system to support smoking cessation among US smokers.
OBJECTIVE


The aim of this study is to adapt the aforementioned system for rural Vietnamese smokers to promote cessation of tobacco use, both directly and by increasing the use of telephone Quitline counseling services and nicotine replacement therapy. Moreover, we seek to enhance research and health service capacity in Vietnam.
METHODS


We are testing the effectiveness of our culturally adapted motivational text messaging system by using a community-based randomized controlled trial design (N=600). Participants were randomly allocated to the intervention (regular motivational and assessment text messages) or control condition (assessment text messages only) for a period of 6 months. Trial recruitment took place in four communes in the Hung Yen province in the Red River Delta region of Vietnam. Recruitment events were advertised to the local community, facilitated by community health workers, and occurred in the commune health center. We are assessing the impact of the texting system on 6-month self-reported and biochemically verified smoking cessation, as well as smoking self-efficacy, uptake of the Quitline, and use of nicotine replacement therapy. In addition to conducting the trial, the research team also provided ongoing training and consultation with the Quitline during the study period.
RESULTS


Site preparation, staff training, intervention adaptation, participant recruitment, and baseline data collection were completed. The study was funded in August 2017; it was reviewed and approved by the University of Massachusetts Medical School Institutional Review Board in 2017. Recruitment began in November 2018. A total of 750 participants were recruited from four communes, and 700 (93.3%) participants completed follow-up by March 2021. An analysis of the trial results is in progress; results are expected to be published in late 2022.
CONCLUSIONS


This study examines the effectiveness of mobile health interventions for smoking in rural areas in low- and middle-income countries, which can be implemented nationwide if proven effective. In addition, it also facilitates significant collaboration and capacity building among a variety of international partners, including researchers, policy makers, Quitline counselors, and community health workers.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03567993; https://clinicaltrials.gov/ct2/show/NCT03567993.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/30947.",2021,Participants were randomly allocated to the intervention (regular motivational and assessment text messages) or control condition (assessment text messages only) for a period of 6 months.,"['rural areas in low- and middle-income countries', 'Rural Vietnam', 'four communes in the Hung Yen province in the Red River Delta region of Vietnam', 'The study was funded in August 2017; it was reviewed and approved by the University of Massachusetts Medical School Institutional Review Board in 2017', 'rural Vietnamese smokers', 'A total of 750 participants were recruited from four communes, and 700 (93.3%) participants completed follow-up by March 2021', 'In Vietnam, 1 in every 2 male adults smokes tobacco']","['telephone Quitline counseling', 'intervention (regular motivational and assessment text messages) or control condition (assessment text messages only', 'mHealth Messaging to Motivate Quitline Use and Quitting', 'mobile health interventions', 'nicotine replacement therapy']",[],"[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0337050', 'cui_str': 'River'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]",[],750.0,0.0652907,Participants were randomly allocated to the intervention (regular motivational and assessment text messages) or control condition (assessment text messages only) for a period of 6 months.,"[{'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Larkin', 'Affiliation': 'Department of Emergency Medicine, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wijesundara', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Hoa L', 'Initials': 'HL', 'LastName': 'Nguyen', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Duc Anh', 'Initials': 'DA', 'LastName': 'Ha', 'Affiliation': 'Vietnam Ministry of Health, Hanoi, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vuong', 'Affiliation': 'Institute of Population, Health and Development, Hanoi, Vietnam.'}, {'ForeName': 'Cuong Kieu', 'Initials': 'CK', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Population, Health and Development, Hanoi, Vietnam.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Amante', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Chau Quy', 'Initials': 'CQ', 'LastName': 'Ngo', 'Affiliation': 'Respiratory Center, Bach Mai Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Phuong Thu', 'Initials': 'PT', 'LastName': 'Phan', 'Affiliation': 'Respiratory Center, Bach Mai Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Quyen Thi Le', 'Initials': 'QTL', 'LastName': 'Pham', 'Affiliation': 'Respiratory Center, Bach Mai Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Binh Ngoc', 'Initials': 'BN', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Population, Health and Development, Hanoi, Vietnam.'}, {'ForeName': 'Anh Thi Phuong', 'Initials': 'ATP', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Population, Health and Development, Hanoi, Vietnam.'}, {'ForeName': 'Phuong Thi Thu', 'Initials': 'PTT', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Population, Health and Development, Hanoi, Vietnam.'}, {'ForeName': 'Sharina', 'Initials': 'S', 'LastName': 'Person', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Houston', 'Affiliation': 'Wake Forest School of Medicine, Wake Forest University, Winston-Salem, NC, United States.'}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Sadasivam', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}]",JMIR research protocols,['10.2196/30947']
1855,34617912,Remote Blood Pressure Monitoring With a Wearable Photoplethysmographic Device (Senbiosys): Protocol for a Single-Center Prospective Clinical Trial.,"BACKGROUND


Wearable devices can provide user-friendly, accurate, and continuous blood pressure (BP) monitoring to assess patients' vital signs and achieve remote patient management. Remote BP monitoring can substantially improve BP control. The newest cuffless BP monitoring devices have emerged in patient care using photoplethysmography.
OBJECTIVE


The Senbiosys trial aims to compare BP measurements of a new device capturing a photoplethysmography signal on the finger versus invasive measurements performed in patients with an arterial catheter in the intensive care unit (ICU) or referred for a coronarography at the Hospital of Fribourg.
METHODS


The Senbiosys study is a single-center, single-arm, prospective trial. The study population consists of adult patients undergoing coronarography or patients in the ICU with an arterial catheter in place. This study will enroll 35 adult patients, including 25 patients addressed for a coronarography and 10 patients in the ICU. The primary outcome is the assessment of mean bias (95% CI) for systolic BP, diastolic BP, and mean BP between noninvasive and invasive BP measurements. Secondary outcomes include a reliability index (Qualification Index) for BP epochs and count of qualified epochs.
RESULTS


Patient recruitment started in June 2021. Results are expected to be published by December 2021.
CONCLUSIONS


The findings of the Senbiosys trial are expected to improve remote BP monitoring. The diagnosis and treatment of hypertension should benefit from these advancements.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04379986; https://clinicaltrials.gov/ct2/show/NCT04379986.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/30051.",2021,Remote BP monitoring can substantially improve BP control.,"['35 adult patients, including 25 patients addressed for a coronarography and 10 patients in the ICU', 'adult patients undergoing coronarography or patients in the ICU with an arterial catheter in place', 'patients with an arterial catheter in the intensive care unit (ICU) or referred for a coronarography at the Hospital of Fribourg']","['new device capturing a photoplethysmography signal', 'Remote Blood Pressure Monitoring With a Wearable Photoplethysmographic Device (Senbiosys): Protocol']","['assessment of mean bias (95% CI) for systolic BP, diastolic BP, and mean BP between noninvasive and invasive BP measurements', 'reliability index (Qualification Index) for BP epochs and count of qualified epochs', 'BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0421449', 'cui_str': 'Patient address'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0581447', 'cui_str': 'Arterial catheter'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0428890', 'cui_str': 'Invasive arterial pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",35.0,0.370686,Remote BP monitoring can substantially improve BP control.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schukraft', 'Affiliation': 'Department of Cardiology, University and Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Assim', 'Initials': 'A', 'LastName': 'Boukhayma', 'Affiliation': ""Microcity Pôle d'innovation Neuchâtel, Neuchâtel, Switzerland.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, University and Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Caizzone', 'Affiliation': ""Microcity Pôle d'innovation Neuchâtel, Neuchâtel, Switzerland.""}]",JMIR research protocols,['10.2196/30051']
1856,34617908,Delivering Cardiac Rehabilitation Exercise Virtually Using a Digital Health Platform (ECME-CR): Protocol for a Pilot Trial.,"BACKGROUND


Exercise-based cardiac rehabilitation is recognized as a core component of cardiovascular disease management and has been shown to reduce all-cause and cardiovascular mortality and reduce the risk of hospital readmission following a cardiac event. However, despite this, the uptake of and long-term adherence to cardiac rehabilitation exercise is poor. Delivering cardiac rehabilitation exercise virtually (ie, allowing patients to participate from their own homes) may be an alternative approach that could enhance uptake and increase adherence.
OBJECTIVE


The aim of this study is to assess the feasibility of delivering a virtual cardiac rehabilitation exercise program supported by the Eastern Corridor Medical Engineering - Cardiac Rehabilitation (ECME-CR) platform.
METHODS


A convenience sample (n=20) of participants eligible to participate in community-based cardiac rehabilitation exercise will be recruited. Participants will be randomized to one of two study groups. Both study groups will perform the same exercise program, consisting of twice-weekly sessions of 60 minutes each, over an 8-week intervention period. Participants in the intervention group will partake in virtually delivered cardiac rehabilitation exercise classes in their own home. The virtual exercise classes will be delivered to participants using a videoconferencing platform. Participants in the control group will attend the research center for their cardiac rehabilitation exercise classes. Intervention group participants will receive the ECME-CR digital health platform for monitoring during the class and during the intervention period. Outcomes will be assessed at baseline and following the 8-week intervention period. The primary outcome will be exercise capacity as assessed using the 6-minute walk test. Other outcome measures will include heart rate, blood pressure, weight, percentage body fat, muscle strength, and self-reported quality of life. Semistructured interviews will also be conducted with a subset of participants to explore their experiences of using the digital platform.
RESULTS


Participant recruitment and data collection will begin in July 2021, and it is anticipated that the study results will be available for dissemination in spring 2022.
CONCLUSIONS


This pilot trial will inform the design of a randomized controlled trial that will assess the clinical effectiveness of the ECME-CR digital health platform.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/31855.",2021,Intervention group participants will receive the ECME-CR digital health platform for monitoring during the class and during the intervention period.,['A convenience sample (n=20) of participants eligible to participate in community-based cardiac rehabilitation exercise will be recruited'],"['cardiac rehabilitation exercise classes', 'Delivering Cardiac Rehabilitation Exercise', 'ECME-CR digital health platform', 'virtual cardiac rehabilitation exercise program', 'Delivering cardiac rehabilitation exercise']","['exercise capacity as assessed using the 6-minute walk test', 'heart rate, blood pressure, weight, percentage body fat, muscle strength, and self-reported quality of life']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0454306', 'cui_str': 'Exercise class'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0275325,Intervention group participants will receive the ECME-CR digital health platform for monitoring during the class and during the intervention period.,"[{'ForeName': 'Oonagh M', 'Initials': 'OM', 'LastName': 'Giggins', 'Affiliation': 'NetwellCASALA, Dundalk Institute of Technology, Dundalk, Ireland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Doyle', 'Affiliation': 'NetwellCASALA, Dundalk Institute of Technology, Dundalk, Ireland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'NetwellCASALA, Dundalk Institute of Technology, Dundalk, Ireland.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Moran', 'Affiliation': 'NetwellCASALA, Dundalk Institute of Technology, Dundalk, Ireland.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Gavin', 'Affiliation': 'NetwellCASALA, Dundalk Institute of Technology, Dundalk, Ireland.'}, {'ForeName': 'Nisanth', 'Initials': 'N', 'LastName': 'Sojan', 'Affiliation': 'NetwellCASALA, Dundalk Institute of Technology, Dundalk, Ireland.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Boyle', 'Affiliation': 'NetwellCASALA, Dundalk Institute of Technology, Dundalk, Ireland.'}]",JMIR research protocols,['10.2196/31855']
1857,34614266,The effect of oxygen concentration on atelectasis formation during induction of general anesthesia in children: A prospective randomized controlled trial.,"BACKGROUND


In adults, the use of lower oxygen concentration during induction is associated with less atelectasis formation without an increase in incidence of hypoxia. However, it is unknown whether this remains true in the pediatric patients.
METHODS


Fifty-four pediatric patients who were scheduled to undergo elective lower abdominal surgery were randomized to one of three oxygenation groups: 100%, 80%, or 60% oxygen (in air). During anesthesia induction, patients were ventilated with sevoflurane in 100%, 80%, or 60% oxygen. Endotracheal intubation and mechanical ventilation were performed. Atelectasis was diagnosed using LUS, which was performed after anesthetic induction and at the end of surgery.
RESULTS


We assessed atelectasis after anesthetic induction and at the end of surgery. After anesthetic induction, the number of atelectatic lung regions was significantly different among the three groups (median [IQR], 2.0 [1.0-2.5], 2.0 [1.0-2.8], and 3.0 [2.0-3.0] in the 60%, 80%, and 100% oxygen groups, p = .033) and between the 60% and 100% groups (p = .015), but not between 80% and 100% groups (p = .074). However, no differences in the number of atelectatic lung regions were found among the three groups at the end of surgery (2.0 [1.3-3.8], 3.0 [1.8-3.0], and 4.0 [2.0-4.0] in the 60%, 80%, and 100% oxygen groups; p = .169).
CONCLUSION


Lower oxygen concentration during anesthetic induction is associated with less atelectasis formation immediately after anesthetic induction in children. In addition, applying 80% oxygen instead of 100% oxygen is not enough to prevent atelectasis formation, and 60% oxygen should be applied to prevent atelectasis. However, this effect does not last until the end of surgery.",2021,"However, no differences in the number of atelectatic lung regions were found among the three groups at the end of surgery (2.0 [1.3 to 3.8], 3.0 [1.8 to 3.0], and 4.0 [2.0 to 4.0] in the 60%, 80%, and 100% oxygen groups; P = 0.169).
","['children', 'Children', 'paediatric patients', 'Fifty-four paediatric patients who were scheduled to undergo elective lower abdominal surgery']","['Endotracheal intubation and mechanical ventilation', 'Oxygen Concentration', 'sevoflurane']",['number of atelectatic lung regions'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439688', 'cui_str': 'Atelectatic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",54.0,0.257404,"However, no differences in the number of atelectatic lung regions were found among the three groups at the end of surgery (2.0 [1.3 to 3.8], 3.0 [1.8 to 3.0], and 4.0 [2.0 to 4.0] in the 60%, 80%, and 100% oxygen groups; P = 0.169).
","[{'ForeName': 'Hyun Il', 'Initials': 'HI', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Min', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Jeong-Rim', 'Initials': 'JR', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Choi', 'Initials': 'C', 'LastName': 'Kwan Woong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, National Health Insurance Service Il San Hospital, Goyang-si, Korea.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, National Health Insurance Service Il San Hospital, Goyang-si, Korea.'}, {'ForeName': 'Hyo-Jin', 'Initials': 'HJ', 'LastName': 'Byon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea.'}]",Paediatric anaesthesia,['10.1111/pan.14304']
1858,34613954,"Determination of Urinary Gluten Immunogenic Peptides to Assess Adherence to the Gluten-Free Diet: A Randomized, Double-Blind, Controlled Study.","INTRODUCTION


The adherence to a gluten-free diet (GFD) is a trending topic in the management of celiac disease. The aim of our study was to evaluate the diagnostic performance of urinary gluten immunogenic peptides (GIP) determination to detect gluten contamination of the GFD.
METHODS


In study A, 25 healthy adults on a standard GFD performed 6 gluten challenges (0, 10, 50, 100, 500, and 1,000 mg) with quantification of urinary GIP before (T0) and during the following 24 hours. In study B, 12 participants on a gluten contamination elimination diet underwent urinary GIP determination at T0 and after challenge with 5 or 10 mg gluten. Urine GIP concentration was determined by an immunochromatographic assay.
RESULTS


In study A, 51 of 150 baseline urine samples were GIP+ on GFD and 7 of 17 were GIP+ after the zero-gluten challenge, whereas only 55 of 81 were GIP+ after the 10-1,000 mg gluten challenges. There was no significant change in the 24-hour urinary GIP when increasing gluten from 10 to 1,000 mg. In study B, 24 of 24 baseline urine samples were GIP-, whereas 8 of 24 were GIP+ after 5 or 10 mg of gluten.
DISCUSSION


Traces of gluten in the standard GFD may cause positivity of urinary GIP determination, whereas a false negativity is common after a gluten intake of 10-1,000 mg. Owing to the impossibility of standardizing the test in normal conditions, it seems unlikely that urinary GIP determination may represent a reliable tool to assess the compliance to the GFD of patients with celiac disease or other gluten-related disorders.",2021,"There was no significant change in the 24-hour urinary GIP when increasing gluten from 10 to 1,000 mg.","['12 participants on a gluten contamination elimination diet underwent urinary GIP determination at T0 and after challenge with 5 or 10 mg gluten', 'patients with celiac disease or other gluten-related disorders', '25 healthy adults on a standard GFD performed 6 gluten challenges (0, 10, 50, 100, 500, and 1,000 mg) with quantification of urinary GIP before (T0) and during the following 24 hours']","['urinary gluten immunogenic peptides (GIP', 'gluten-free diet (GFD']","['24-hour urinary GIP', 'Urine GIP concentration']","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0452376', 'cui_str': 'Elimination diet'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",25.0,0.147122,"There was no significant change in the 24-hour urinary GIP when increasing gluten from 10 to 1,000 mg.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Monachesi', 'Affiliation': 'Celiac Disease Research Laboratory, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': 'Verma', 'Affiliation': 'Celiac Disease Research Laboratory, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Giulia N', 'Initials': 'GN', 'LastName': 'Catassi', 'Affiliation': 'Division of Pediatrics, DISCO Department, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Franceschini', 'Affiliation': 'Division of Pediatrics, DISCO Department, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Gatti', 'Affiliation': 'Division of Pediatrics, DISCO Department, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Gesuita', 'Affiliation': 'Center of Epidemiology and Biostatistics, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Lionetti', 'Affiliation': 'Division of Pediatrics, DISCO Department, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Catassi', 'Affiliation': 'Division of Pediatrics, DISCO Department, Polytechnic University of Marche, Ancona, Italy.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000411']
1859,34619438,"ND0612 (levodopa/carbidopa for subcutaneous infusion) in patients with Parkinson's disease and motor response fluctuations: A randomized, placebo-controlled phase 2 study.","INTRODUCTION


ND0612 is a continuous, subcutaneous levodopa/carbidopa delivery system under development for patients with Parkinson's disease (PD) and motor fluctuations.
METHODS


This was a randomized, placebo-controlled, double-blind, 2-period study evaluating the safety and pharmacokinetics of ND0612 in PD patients on an optimized oral levodopa regimen and experiencing ≥2 h/day of OFF time. During Period-1, patients received their current standard of care (SoC) levodopa/carbidopa and were randomized (2:1) to 14 days treatment with adjunct ND0612 (daily levodopa/carbidopa dose of 270/63 mg) or placebo infusion +SoC. During Period-2, 16 patients were randomized to receive 7 days treatment with ND0612 or ND0612 plus oral entacapone. Reduction in OFF time was analyzed as an exploratory measure using a futility design with a predefined margin of 1.6 h.
RESULTS


ND0612 was well-tolerated; most patients experienced infusion site nodules (95% vs. 56% with placebo), which all resolved without sequelae. Patients treated with adjunct ND0612 during Period-1 avoided deep troughs in levodopa plasma levels and had a decreased fluctuation index versus placebo (1.6 ± 0.5 vs 3.1 ± 1.6 at end of Period-1, respectively). In Period-2, the coadministration of entacapone with continuous ND0612 SC infusion translated to an increase in mean levodopa AUC 0-10h  compared to baseline. Exploratory efficacy analysis of Period 1 showed mean ± SD OFF time reductions of -2.13 ± 2.24 [90%CI: -2.8, ∞] hours (p = 0.84 using H 0  of μ 0  ≤-1.6).
CONCLUSION


Levodopa/carbidopa infusion with ND0612 was generally well-tolerated and resulted in reduced fluctuations in plasma levodopa concentrations when given with SoC oral levodopa. ND0612 met the efficacy endpoint for the futility design.",2021,"ND0612 was well-tolerated; most patients experienced infusion site nodules (95% vs. 56% with placebo), which all resolved without sequelae.","[""patients with Parkinson's disease and motor response fluctuations"", ""patients with Parkinson's disease (PD) and motor fluctuations"", 'PD patients on an optimized oral levodopa regimen and experiencing ≥2\xa0h/day of OFF time']","['90%CI', 'entacapone', 'ND0612 or ND0612 plus oral entacapone', 'Levodopa/carbidopa', 'levodopa/carbidopa', 'ND0612 (levodopa/carbidopa', 'adjunct ND0612 (daily levodopa/carbidopa dose of 270/63\xa0mg) or placebo infusion\xa0+SoC', 'current standard of care (SoC) levodopa/carbidopa', 'placebo']","['plasma levodopa concentrations', 'OFF time', 'mean levodopa AUC', 'mean\xa0±\xa0SD OFF time reductions of -2.13\xa0±', 'levodopa plasma levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C1868976', 'cui_str': 'Motor fluctuations'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0165921', 'cui_str': 'entacapone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",16.0,0.14176,"ND0612 was well-tolerated; most patients experienced infusion site nodules (95% vs. 56% with placebo), which all resolved without sequelae.","[{'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Giladi', 'Affiliation': 'Neurological Institute, Tel Aviv Medical Center, 6 Weizmann Street, Tel Aviv, 6423906, Israel; Sackler School of Medicine, Tel Aviv University, P.O. Box 39040, Tel Aviv, 6997801, Israel; Sagol School of Neuroscience, Tel Aviv University, P.O. Box 39040, Tel Aviv, 6997801, Israel. Electronic address: nirg@tlvmc.gov.il.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Gurevich', 'Affiliation': 'Neurological Institute, Tel Aviv Medical Center, 6 Weizmann Street, Tel Aviv, 6423906, Israel; Sackler School of Medicine, Tel Aviv University, P.O. Box 39040, Tel Aviv, 6997801, Israel; Sagol School of Neuroscience, Tel Aviv University, P.O. Box 39040, Tel Aviv, 6997801, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Djaldetti', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, P.O. Box 39040, Tel Aviv, 6997801, Israel; Department of Neurology, Rabin Medical Center, Zeev Jabotinsky St 39, Petah Tikva, 49100, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Adar', 'Affiliation': 'NeuroDerm Ltd, 3 Pekeris Street, Ruhrberg Science Bldg., Rabin Science Park, Rehovot, Israel.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Case', 'Affiliation': 'NeuroDerm Ltd, 3 Pekeris Street, Ruhrberg Science Bldg., Rabin Science Park, Rehovot, Israel.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Leibman-Barak', 'Affiliation': 'NeuroDerm Ltd, 3 Pekeris Street, Ruhrberg Science Bldg., Rabin Science Park, Rehovot, Israel.'}, {'ForeName': 'Nissim', 'Initials': 'N', 'LastName': 'Sasson', 'Affiliation': 'NeuroDerm Ltd, 3 Pekeris Street, Ruhrberg Science Bldg., Rabin Science Park, Rehovot, Israel.'}, {'ForeName': 'Yoseph', 'Initials': 'Y', 'LastName': 'Caraco', 'Affiliation': ""Hadassah Medical Center, Kalman Ya'akov Man St, Jerusalem, 91200, Israel.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2021.09.024']
1860,34619378,Effect of desflurane on changes in regional cerebral oxygenation in patients undergoing one-lung ventilation is equivalent to the effect of propofol.,"OBJECTIVES


Desaturation is an important clinical problem during one-lung ventilation (OLV) since it may induce cerebral hypoxia. Measurement of cerebral oxygenation has been shown to provide accurate information about episodes of cerebral hypoxemia. The purpose of this study was to compare the effect of desflurane on changes in cerebral oxygenation during OLV with the effect of propofol.
METHODS


A randomized, single-blinded, prospective study was conducted. Fifty adult patients who were scheduled to undergo thoracic surgery were randomly assigned to anesthetic management using desflurane with remifentanil (Group D: n = 25) or using propofol and remifentanil (Group P: n = 25).
RESULTS


The characteristics of the patients were very similar. Intergroup analysis of changes in cerebral oxygenation showed no significant difference on the operative side (two-way ANOVA, F (7, 368) = 0.425, p = 0.887) or the non-operative side (two-way ANOVA, F (7, 367) = 1.342, p = 0.229). Intragroup analysis of changes in cerebral oxygenation using one-way ANOVA showed no significant difference on the operative side (Group P; p = 0.585, Group D; p = 0.928) or the non-operative side in both groups (Group P; p = 0.657, Group D; p = 0.602).
CONCLUSIONS


The effects of desflurane and propofol on changes in cerebral oxygenation in patients undergoing OLV were equivalent. Our results indicated that desflurane might be an appropriate anesthetic during OLV for maintaining cerebral oxygenation with an effective equivalent to that of propofol.",2021,"Intergroup analysis of changes in cerebral oxygenation showed no significant difference on the operative side (two-way ANOVA, F (7, 368) = 0.425, p = 0.887) or the non-operative side (two-way ANOVA, F (7, 367) = 1.342, p = 0.229).","['patients undergoing one-lung ventilation', 'Fifty adult patients who were scheduled to undergo thoracic surgery', 'patients undergoing OLV']","['desflurane with remifentanil', 'desflurane', 'propofol and remifentanil', 'propofol', 'desflurane and propofol']","['cerebral oxygenation', 'regional cerebral oxygenation', 'operative side']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",50.0,0.0447102,"Intergroup analysis of changes in cerebral oxygenation showed no significant difference on the operative side (two-way ANOVA, F (7, 368) = 0.425, p = 0.887) or the non-operative side (two-way ANOVA, F (7, 367) = 1.342, p = 0.229).","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, West 16, South 1, Chuo-ward, Sapporo, Hokkaido, 060-8543, Japan. Electronic address: sucrose0711@gmail.com.'}, {'ForeName': 'Mitsutaka', 'Initials': 'M', 'LastName': 'Edanaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, West 16, South 1, Chuo-ward, Sapporo, Hokkaido, 060-8543, Japan.'}, {'ForeName': 'Mamiko', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, West 16, South 1, Chuo-ward, Sapporo, Hokkaido, 060-8543, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, West 16, South 1, Chuo-ward, Sapporo, Hokkaido, 060-8543, Japan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2021.103798']
1861,34619376,"A commentary on ""Milrinone is better choice for controlled low central venous pressure during hepatectomy: A randomized, controlled trial comparing with nitroglycerin"" [Int. J. Surg. (2021) 94: 106080].",,2021,,['controlled low central venous pressure during hepatectomy'],"['Milrinone', 'nitroglycerin"" [Int']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0128513', 'cui_str': 'Milrinone'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}]",[],,0.223708,,"[{'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Pediatric Surgery, Ruijin Maternal and Child Health Hospital, Ganzhou, China.'}, {'ForeName': 'Zhangzhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Ultrasound, Jinhua First People's Hospital, Jinhua, China.""}, {'ForeName': 'Zeming', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: zeminghu1026@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106130']
1862,34626293,Evaluating a Sport-Based Mental Health Literacy Intervention in Australian Amateur Sporting Adolescents.,"Youth amateur sporting environments present an untapped, under-researched, and potentially vital avenue for targeted mental health intervention programs. This study evaluates such an intervention in 12 sporting clubs, comprising of 330 Australian youth aged 12-15 years (M = 13.73, SD = 0.79). Mental health literacy, help-seeking intentions, and help-seeking behaviors were measured throughout the season using a repeated-measures experimental-control design. Multilevel modelling revealed the intervention successfully improved mental health literacy and help-seeking intentions in particular cohorts, such as youth scoring low in these constructs pre-intervention and youth who had not previously received the intervention. This study demonstrates the efficacy of interventions to effect positive change in amateur sporting youth, highlighting a convenient method to improve mental health in young people.",2021,"Multilevel modelling revealed the intervention successfully improved mental health literacy and help-seeking intentions in particular cohorts, such as youth scoring low in these constructs pre-intervention and youth who had not previously received the intervention.","['Australian Amateur Sporting Adolescents', 'amateur sporting youth', '12 sporting clubs, comprising of 330 Australian youth aged 12-15 years (M\u2009=\u200913.73, SD\u2009=\u20090.79', 'young people']",['Sport-Based Mental Health Literacy Intervention'],"['Mental health literacy, help-seeking intentions, and help-seeking behaviors', 'mental health literacy and help-seeking intentions', 'mental health']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0683301', 'cui_str': 'Help-Seeking Behavior'}]",330.0,0.0263471,"Multilevel modelling revealed the intervention successfully improved mental health literacy and help-seeking intentions in particular cohorts, such as youth scoring low in these constructs pre-intervention and youth who had not previously received the intervention.","[{'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Patafio', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Waterfront Campus, Locked Bag 20001, Geelong, VIC, 3220, Australia. brittany.patafio@deakin.edu.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Skvarc', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Waterfront Campus, Locked Bag 20001, Geelong, VIC, 3220, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Miller', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Waterfront Campus, Locked Bag 20001, Geelong, VIC, 3220, Australia.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hyder', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Waterfront Campus, Locked Bag 20001, Geelong, VIC, 3220, Australia.'}]",Journal of youth and adolescence,['10.1007/s10964-021-01513-0']
1863,34624334,Short-wavelength blue light contributes to the pyroptosis of human lens epithelial cells (hLECs).,"PURPOSE


The purpose of this study is to examine the effect of short-wavelength blue light (SWBL) on cultured human lens epithelial cells (hLECs). The pathogenesis of cataracts after SWBL exposure is discussed.
METHODS


HLE-B3 hLECs were randomly divided into 3 groups: the NC group, which was grown in a dark incubator; the acetyl (Ac)-Tyr-Val-Ala-Asp-chloromethyl ketone (AC-YVAD-CMK) treatment group; and the SWBL exposure group. After SWBL (2500 lux) irradiation (for 8, 16, 24, and 32 h), caspase-1 and gasdermin D (GSDMD) expression levels in HLE-B3 hLECs were examined using ELISA, immunofluorescence staining, and Western blotting analyses. Double-positive staining of hLECs for activated and inhibited caspase-1 was used to determine pyroptosis in HLE-B3 hLECs.
RESULTS


SWBL led to hLEC death, but a caspase-1 inhibitor suppressed cell death. The flow cytometry results also confirmed the dose-dependent effect of SWBL irradiation on the pyroptotic death of hLECs. Caspase-1 and GSDMD expression levels in all hLEC groups changed with blue light exposure times (8, 16, 24, and 32 h) and were higher in the AC-YVAD-CMK and SWBL exposure groups than in the NC group. The immunofluorescence results revealed higher GSDMD-N expression in the cell membrane of both the AC-YVAD-CMK and SWBL exposure groups than in the NC group.
CONCLUSIONS


Based on the data, SWBL induces pyroptotic programmed cell death by activating the GSDMD signalling axis in HLE-B3 hLECs. These results provide new insights into the exploitation of new candidates for the prevention of cataracts.",2021,The flow cytometry results also confirmed the dose-dependent effect of SWBL irradiation on the pyroptotic death of hLECs.,['HLE-B3 hLECs'],"['NC group, which was grown in a dark incubator; the acetyl (Ac)-Tyr-Val-Ala-Asp-chloromethyl ketone (AC-YVAD-CMK) treatment group; and the SWBL exposure group', 'short-wavelength blue light (SWBL']","['cell death', 'GSDMD-N expression', 'Caspase-1 and GSDMD expression levels', 'caspase-1 and gasdermin D', 'pyroptotic death of hLECs']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0014597', 'cui_str': 'Epithelial cell'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C0041484', 'cui_str': 'Monophenol monooxygenase'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0525815', 'cui_str': 'alanylaspartic acid'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0388131', 'cui_str': 'N-acetyl-tyrosyl-valyl-alanyl-aspartyl chloromethyl ketone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0303896', 'cui_str': 'Blue light'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0007587', 'cui_str': 'Cell death'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0534519', 'cui_str': 'Caspase-1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0014597', 'cui_str': 'Epithelial cell'}]",,0.0850967,The flow cytometry results also confirmed the dose-dependent effect of SWBL irradiation on the pyroptotic death of hLECs.,"[{'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Eye Hospital, The First Affiliated Hospital of Harbin Medical University, China.'}, {'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Eye Hospital, The First Affiliated Hospital of Harbin Medical University, China.'}, {'ForeName': 'Huazhang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Eye Hospital, The First Affiliated Hospital of Harbin Medical University, China.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Eye Hospital, The First Affiliated Hospital of Harbin Medical University, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Eye Hospital, The First Affiliated Hospital of Harbin Medical University, China; Department of Ophthalmology, Second Hospital of Heilongjiang Province, Harbin, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Eye Hospital, The First Affiliated Hospital of Harbin Medical University, China.'}, {'ForeName': 'Meiyu', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Eye Hospital, The First Affiliated Hospital of Harbin Medical University, China.'}, {'ForeName': 'Yuexing', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Eye Hospital, The First Affiliated Hospital of Harbin Medical University, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Eye Hospital, The First Affiliated Hospital of Harbin Medical University, China.'}, {'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Eye Hospital, The First Affiliated Hospital of Harbin Medical University, China. Electronic address: lzj6515@sina.com.'}]",Experimental eye research,['10.1016/j.exer.2021.108786']
1864,34626843,Effects of modifying the electrode placement and pulse width on cognitive side effects with unilateral ECT: A pilot randomised controlled study with computational modelling.,"BACKGROUND


The electrode placement and pulse width for electroconvulsive therapy (ECT) are important treatment parameters associated with ECT related retrograde memory side-effects. Modification of these parameters with right unilateral (RUL) ECT may have utility for further reducing these side-effects.
OBJECTIVE


This study explored use of the frontoparietal (FP) placement for reducing retrograde memory side effects with ECT. We hypothesised that superior retrograde memory outcomes would occur with FP compared to temporoparietal (TP) placement and with ultrabrief (UB: 0.3 ms) compared to brief pulse (BP: 1.0 ms) width ECT.
METHODS


In this randomised cross-over, double-blinded study, participants received a single treatment of BP TP, BP FP, UB TP and UB FP ECT. Neuropsychological testing was conducted prior to and immediately following each treatment. Computational modelling was conducted to explore associations between E-fields in regions-of-interest associated with memory.
RESULTS


Nine participants completed the study. The FP placement was not superior to TP for retrograde memory outcomes. For both electrode placements UB pulse width was associated with significantly better visual retrograde memory compared to BP (p < .05). With TP ECT, higher E-fields in regions-of-interest were significantly associated with greater visual retrograde memory side-effects (hippocampi: r = -0.77, p = .04; inferior frontal gyri: r = -0.92, p < .01; middle frontal gyri: r = -0.84, p = .02).
CONCLUSIONS


Modification of pulse-width had greater effects than electrode placement for reducing retrograde memory side-effects with RUL ECT. Preliminary findings suggested that higher E-fields may be associated with greater cognitive side-effects with ECT.",2021,For both electrode placements UB pulse width was associated with significantly better visual retrograde memory compared to BP (p < .05).,['Nine participants completed the study'],"['BP TP, BP FP, UB TP and UB FP ECT', 'TP ECT', 'electrode placement', 'electrode placement and pulse width', 'unilateral ECT', 'electroconvulsive therapy (ECT', 'ECT', 'frontoparietal (FP) placement', 'right unilateral (RUL) ECT']","['middle frontal gyri', 'visual retrograde memory', 'visual retrograde memory side-effects']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0444804', 'cui_str': 'Brief pulse'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",9.0,0.0815536,For both electrode placements UB pulse width was associated with significantly better visual retrograde memory compared to BP (p < .05).,"[{'ForeName': 'Donel M', 'Initials': 'DM', 'LastName': 'Martin', 'Affiliation': 'Black Dog Institute, Sydney, NSW, Australia; School of Psychiatry, University of New South Wales, Sydney, NSW, Australia. Electronic address: donel.martin@unsw.edu.au.'}, {'ForeName': 'Azam Ahmad', 'Initials': 'AA', 'LastName': 'Bakir', 'Affiliation': 'Graduate School of Biomedical Engineering, University of New South Wales, NSW, Australia; University of Southampton Malaysia Campus, Iskandar Puteri, Johor, Malaysia.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Black Dog Institute, Sydney, NSW, Australia.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Francis-Taylor', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Alduraywish', 'Affiliation': 'Graduate School of Biomedical Engineering, University of New South Wales, NSW, Australia; College of Applied Medical Sciences, Majmaah University, Saudi Arabia.'}, {'ForeName': 'Siwei', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Graduate School of Biomedical Engineering, University of New South Wales, NSW, Australia.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Hadzi-Pavlovic', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Socrates', 'Initials': 'S', 'LastName': 'Dokos', 'Affiliation': 'Graduate School of Biomedical Engineering, University of New South Wales, NSW, Australia.'}, {'ForeName': 'Colleen K', 'Initials': 'CK', 'LastName': 'Loo', 'Affiliation': 'Black Dog Institute, Sydney, NSW, Australia; School of Psychiatry, University of New South Wales, Sydney, NSW, Australia; St George Hospital, South Eastern Sydney Health, Sydney, NSW, Australia.'}]",Brain stimulation,['10.1016/j.brs.2021.09.014']
1865,34626925,Children's group identity is related to their assessment of fair and unfair advantages.,"Unfair advantages can be created either intentionally (e.g., cheating) or unintentionally (e.g., unintended benefit). Little is known regarding how children evaluate different types of advantages in situations where group identity and group membership are made salient. To investigate how children's group identity influences their evaluations and attribution of intentions in intergroup contexts, children were presented with three hypothetical advantages (unintentionally unfair, intentionally unfair, and fair) in a competitive context created by either an in-group member or an out-group member. Children (N = 120) were 4-6 years of age (n = 59; M age  = 5.29 years) and 7-10 years of age (n = 61; M age  = 8.34 years), including 64 girls and 56 boys. Participants were 67% European American, 18% African American, 11% Asian American, and 4% Hispanic. All participants were assigned to one of two teams in a contest in order to create an in-group/out-group manipulation prior to their evaluation of the actions. Out-group members viewed unintentional unfair and fair advantages as less acceptable than in-group members, but in-group and out-group members were equally negative in their assessment of an intentional transgression. When reasoning about unintentional and intentional unfair advantages, older children referenced the intentions of the advantage creator to justify their decisions more than younger children, whereas younger children reasoned about the impact of the behavior on their team more than older children. These novel findings shed light on developmental and social factors influencing children's understanding of fairness and intentionality in everyday contexts.",2021,These novel findings shed light on developmental and social factors influencing children's understanding of fairness and intentionality in everyday contexts.,"['Children (N\xa0=\xa0120) were 4-6\xa0years of age (n\xa0=\xa059; M age \xa0=\xa05.29\xa0years) and 7-10\xa0years of age (n\xa0=\xa061; M age \xa0=\xa08.34\xa0years), including 64 girls and 56 boys', 'Participants were 67% European American, 18% African American, 11% Asian American, and 4% Hispanic']",[],['unintentional unfair and fair advantages'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0003988', 'cui_str': 'Asian Americans'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]",[],"[{'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C2911689', 'cui_str': 'Fair'}]",120.0,0.0398835,These novel findings shed light on developmental and social factors influencing children's understanding of fairness and intentionality in everyday contexts.,"[{'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': ""D'Esterre"", 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, College Park, MD 20742, USA. Electronic address: desterre@umd.edu.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Woodward', 'Affiliation': 'Department of Psychology, University of Maryland, Baltimore County, Baltimore, MD 21250, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Killen', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, College Park, MD 20742, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2021.105292']
1866,34626915,"A pilot randomized controlled trial examining the benefits of an adjuvant psycho-behavioural intervention in comparison to a health education program, on psychological well-being and freezing-of-gait in patients with Parkinson's disease.","This study investigated the effectiveness of a psycho-behavioural intervention (PBI) for freezing of gait (FOG) management in people with Parkinson's disease, through a double-blind randomized controlled pilot trial conducted with nineteen participants. Though no significant between-group differences were found, PBI was feasible, well-tolerated by participants, and exhibited a trend towards improvement for FOG and depression, thereby warranting further longitudinal investigations.",2021,"Though no significant between-group differences were found, PBI was feasible, well-tolerated by participants, and exhibited a trend towards improvement for FOG and depression, thereby warranting further longitudinal investigations.","['nineteen participants', ""people with Parkinson's disease"", ""patients with Parkinson's disease""]","['adjuvant psycho-behavioural intervention', 'psycho-behavioural intervention (PBI) for freezing of gait (FOG) management']","['FOG and depression', 'PBI was feasible, well-tolerated']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",19.0,0.218253,"Though no significant between-group differences were found, PBI was feasible, well-tolerated by participants, and exhibited a trend towards improvement for FOG and depression, thereby warranting further longitudinal investigations.","[{'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Scully', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, 169608, Singapore. Electronic address: a.scully@postgrad.curtin.edu.au.'}, {'ForeName': 'Kinjal', 'Initials': 'K', 'LastName': 'Doshi', 'Affiliation': 'Department of Psychology, Singapore General Hospital, 169608, Singapore. Electronic address: kinjal.doshi@sgh.com.sg.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychology, Singapore General Hospital, 169608, Singapore. Electronic address: stacey.lee.henderson@sgh.com.sg.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Macas', 'Affiliation': 'National Neuroscience Institute (Singapore General Hospital Campus), 169608, Singapore. Electronic address: mabes980@yahoo.com.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, 169608, Singapore; Health and Social Sciences Cluster, Singapore Institute of Technology, 10 Dover Drive, 138683, Singapore. Electronic address: dawn.tan.m.l@sgh.com.sg.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2021.09.023']
1867,34628275,An experimental examination of interpersonal problem-solving in nonsuicidal self-injury: A pilot study.,"Nonsuicidal self-injury (NSSI) typically occurs in the presence of negative emotions. Prior research has emphasized interpersonal stress as a specific context that may elevate negative emotions in this population and even increase the likelihood of NSSI behavior. However, the factors that contribute to the relationship between interpersonal stress and NSSI have received relatively limited attention. The current pilot study aimed to experimentally examine interpersonal problem-solving as a potential moderator of the interpersonal stress - NSSI risk relationship among those with a NSSI history. Eighty-six participants (52.3% with NSSI history) were randomly assigned to one of three mood induction conditions (interpersonal negative, general negative, interpersonal neutral), after which they completed an interpersonal problem-solving task and a laboratory analogue of self-injurious behavior. Results indicated that NSSI history was associated with poorer interpersonal effectiveness. Further, individuals with a history of NSSI who experienced an interpersonally-focused negative mood and produced less effective interpersonal solutions were more self-harming on a laboratory analogue of self-injurious behavior. While the present findings are preliminary in nature, they offer guidance for research moving forward and, if replicated, suggest interpersonal problem-solving as a potential treatment target among individuals engaging in NSSI.",2021,Results indicated that NSSI history was associated with poorer interpersonal effectiveness.,"['individuals engaging in NSSI', 'those with a NSSI history', 'nonsuicidal self-injury', 'Eighty-six participants (52.3% with NSSI history']","['mood induction conditions (interpersonal negative, general negative, interpersonal neutral), after which they completed an interpersonal problem-solving task and a laboratory analogue of self-injurious behavior', 'interpersonal problem-solving']","['effective interpersonal solutions', 'poorer interpersonal effectiveness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",86.0,0.0156752,Results indicated that NSSI history was associated with poorer interpersonal effectiveness.,"[{'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Ammerman', 'Affiliation': 'University of Notre Dame, Department of Psychology, United States. Electronic address: bammerm1@nd.edu.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Sorgi', 'Affiliation': 'Temple University, Department of Psychology, United States.'}, {'ForeName': 'Martha K', 'Initials': 'MK', 'LastName': 'Fahlgren', 'Affiliation': 'Temple University, Department of Psychology, United States.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Puhalla', 'Affiliation': 'Cincinnati Education and Research for Veterans Foundation, VA Medical Center, United States.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'McCloskey', 'Affiliation': 'Temple University, Department of Psychology, United States.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.09.005']
1868,34628241,"A randomised, double-blind, placebo-controlled clinical trial found that a novel herbal formula Urox® (Bedtime Buddy®) assisted children for the treatment of nocturnal enuresis.","BACKGROUND


Nocturnal enuresis or 'bedwetting', is a form of night-time urinary incontinence occurring in younger children. A diagnosis can be socially disruptive and psychologically stressful for a child. The most common strategies used by parents are waking the child during the night to use the bathroom and limiting the child's water intake before going to bed.
HYPOTHESIS/PURPOSE


To determine if a herbal capsule formulation taken once daily can reduce incidence and frequency of nocturnal enuresis in children.
STUDY DESIGN


This randomised double-blind placebo-controlled trial evaluated the efficacy of an herbal medicine product to reduce the symptoms of nocturnal enuresis. Participants, aged between 6 and 14 years of age, were recruited from the community in Australia. They were randomised via computerised random-number generation at study enrolment to receive one or two oral capsules in the morning of either Urox® (Bedtime Buddy®) or placebo. The Paediatric Quality of life (Pin-Q) was used as a quality-of-life measure and waking wet, fluid intake and urinary urgency per week were monitored.
RESULTS


Forty-one children completed the trial with an attrition rate of 16%. There were more males (64.6%) compared to females (35.4%) and the mean age was 8.6 years. Forty-one point seven percentages (41.7%) of participants had improvements in bed wetting by two months which was a highly clinically relevant effect (Cohen's D = 0.98). The primary outcome found that there was a statistically significant reduction in NE (p = 0.034; CI 0.086-2.095) and between groups using longitudinal analysis (p = 0.04, Coefficient -1.12, CI 95% -2.20 - -0.04). In the secondary outcomes, urinary urgency reduced statistically significantly for the intervention (p = 0.002; a reduction of 18.3% difference for Bedtime Buddy compared to an increase of 3.7% for the placebo).
CONCLUSION


Urox® (Bedtime Buddy®) may assist children in reducing nocturnal enuresis compared to placebo. In addition, it may assist in reducing daily incontinence and urinary urgency.",2021,"In the secondary outcomes, urinary urgency reduced statistically significantly for the intervention (p = 0.002; a reduction of 18.3% difference for Bedtime Buddy compared to an increase of 3.7% for the placebo).
","['Participants, aged between 6 and 14 years of age, were recruited from the community in Australia', 'assisted children for the treatment of nocturnal enuresis', 'males (64.6%) compared to females (35.4%) and the mean age was 8.6 years', 'nocturnal enuresis in children', 'younger children']","['novel herbal formula Urox® (Bedtime Buddy®', 'herbal medicine product', 'Urox® (Bedtime Buddy®', 'placebo', 'Urox® (Bedtime Buddy®) or placebo']","['Paediatric Quality of life (Pin-Q', 'daily incontinence and urinary urgency', 'quality-of-life measure and waking wet, fluid intake and urinary urgency', 'bed wetting', 'nocturnal enuresis', 'attrition rate', 'urinary urgency', 'symptoms of nocturnal enuresis', 'NE']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0270327', 'cui_str': 'Nocturnal enuresis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0270327', 'cui_str': 'Nocturnal enuresis'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",41.0,0.60102,"In the secondary outcomes, urinary urgency reduced statistically significantly for the intervention (p = 0.002; a reduction of 18.3% difference for Bedtime Buddy compared to an increase of 3.7% for the placebo).
","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schloss', 'Affiliation': 'National Centre for Naturopathic Medicine, Southern Cross University, Lismore, NSW, Australia; Australian Research Centre in Complementary and Integrative Medicine, Faculty of Health, University of Technology Sydney, Sydney Australia. Electronic address: janet.schloss@scu.edu.au.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Ryan', 'Affiliation': ""The Royal Brisbane Women's Hospital, Herston, Brisbane, Australia.""}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Steel', 'Affiliation': 'Australian Research Centre in Complementary and Integrative Medicine, Faculty of Health, University of Technology Sydney, Sydney Australia.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2021.153783']
1869,34628232,The psychological effects of blind and open weighing in women with a high drive for thinness: A mixed method inquiry.,"Regular weighing is a routine component of public health interventions but concerns have been raised about possible negative psychological consequences. Blind weighing is an alternative form of weighing that is commonly used in clinical contexts, and that is thought to decrease weighing anxiety and engagement with disordered eating behaviours. In this study, normal weight female participants who indicated a high drive for thinness (N = 53) were randomly assigned to receive bi-weekly open or blind weighing for three weeks. Participants who were open weighed felt increasingly anxious over time, whereas participants who were blind weighed felt less anxious. Both groups experienced increased weight preoccupation and disordered eating behaviours on weighing days compared to non-weighing days. Analyses of participants' qualitative responses further indicated that open weighed participants experienced increased urges to engage in weight-controlling behaviours throughout the experiment whereas blind weighed participants reported reduced concern with weight. Findings suggest that blind weighing may be a safer approach to weight monitoring, even though weighing in both forms can have a (transient) negative effect. Future research should evaluate whether the current findings are generalisable for other subgroups of the population.",2021,Analyses of participants' qualitative responses further indicated that open weighed participants experienced increased urges to engage in weight-controlling behaviours throughout the experiment whereas blind weighed participants reported reduced concern with weight.,"['Participants who were open weighed felt increasingly anxious over time, whereas participants who were blind weighed felt less anxious', 'women with a high drive for thinness', 'normal weight female participants who indicated a high drive for thinness (N\xa0=\xa053']",[],"['weighing anxiety', 'urges to engage in weight-controlling behaviours', 'weight preoccupation and disordered eating behaviours']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0039870', 'cui_str': 'Thin build'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1321111', 'cui_str': 'Weight control behavior'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",53.0,0.0708708,Analyses of participants' qualitative responses further indicated that open weighed participants experienced increased urges to engage in weight-controlling behaviours throughout the experiment whereas blind weighed participants reported reduced concern with weight.,"[{'ForeName': 'Franzisca V', 'Initials': 'FV', 'LastName': 'Froreich', 'Affiliation': 'UNSW Sydney, Faculty of Science, School of Psychology, Sydney, New South Wales 2052, Australia. Electronic address: franzisca.froreich@gmail.com.'}, {'ForeName': 'Lenny R', 'Initials': 'LR', 'LastName': 'Vartanian', 'Affiliation': 'UNSW Sydney, Faculty of Science, School of Psychology, Sydney, New South Wales 2052, Australia.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Grisham', 'Affiliation': 'UNSW Sydney, Faculty of Science, School of Psychology, Sydney, New South Wales 2052, Australia.'}, {'ForeName': 'Rebecca T', 'Initials': 'RT', 'LastName': 'Pinkus', 'Affiliation': 'The University of Sydney, Faculty of Science, School of Psychology, Australia.'}]",Body image,['10.1016/j.bodyim.2021.09.002']
1870,34619989,Pilot study of micromotion nailing for mechanical stimulation of tibial fracture healing.,"AIMS


The study objective was to prospectively assess clinical outcomes for a pilot cohort of tibial shaft fractures treated with a new tibial nailing system that produces controlled axial interfragmentary micromotion. The hypothesis was that axial micromotion enhances fracture healing compared to static interlocking.
METHODS


Patients were treated in a single level I trauma centre over a 2.5-year period. Group allocation was not randomized; both the micromotion nail and standard-of-care static locking nails (control group) were commercially available and selected at the discretion of the treating surgeons. Injury risk levels were quantified using the Nonunion Risk Determination (NURD) score. Radiological healing was assessed until 24 weeks or clinical union. Low-dose CT scans were acquired at 12 weeks and virtual mechanical testing was performed to objectively assess structural bone healing.
RESULTS


A total of 37 micromotion patients and 46 control patients were evaluated. There were no significant differences between groups in terms of age, sex, the proportion of open fractures, or NURD score. There were no nonunions (0%) in the micromotion group versus five (11%) in the control group. The proportion of fractures united was significantly higher in the micromotion group compared to control at 12 weeks (54% vs 30% united; p = 0.043), 18 weeks (81% vs 59%; p = 0.034), and 24 weeks (97% vs 74%; p = 0.005). Structural bone healing scores as assessed by CT scans tended to be higher with micromotion compared to control and this difference reached significance in patients who had biological comorbidities such as smoking.
CONCLUSION


In this pilot study, micromotion fixation was associated with improved healing compared to standard tibial nailing. Further prospective clinical studies will be needed to assess the strength and generalizability of any potential benefits of micromotion fixation. Cite this article:  Bone Jt Open  2021;2(10):825-833.",2021,"Structural bone healing scores as assessed by CT scans tended to be higher with micromotion compared to control and this difference reached significance in patients who had biological comorbidities such as smoking.
","['tibial fracture healing', 'Patients were treated in a single level I trauma centre over a 2.5-year period', '37 micromotion patients and 46 control patients', 'patients who had biological comorbidities such as smoking']","['standard tibial nailing', 'micromotion nailing', 'micromotion nail and standard-of-care static locking nails (control group', 'new tibial nailing system']","['Nonunion Risk Determination (NURD) score', 'Radiological healing', 'Structural bone healing scores', 'fracture healing', 'Injury risk levels', 'proportion of fractures united', 'healing', 'proportion of open fractures, or NURD score']","[{'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0441227', 'cui_str': 'Static locking nail'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0582456', 'cui_str': 'At risk for injury'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0016662', 'cui_str': 'Fracture, open'}]",37.0,0.0236685,"Structural bone healing scores as assessed by CT scans tended to be higher with micromotion compared to control and this difference reached significance in patients who had biological comorbidities such as smoking.
","[{'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Dailey', 'Affiliation': 'Department of Mechanical Engineering & Mechanics, Lehigh University, Bethlehem, Pennsylvania, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schwarzenberg', 'Affiliation': 'Department of Mechanical Engineering & Mechanics, Lehigh University, Bethlehem, Pennsylvania, USA.'}, {'ForeName': 'Edmund B', 'Initials': 'EB', 'LastName': 'Webb Iii', 'Affiliation': 'Department of Mechanical Engineering & Mechanics, Lehigh University, Bethlehem, Pennsylvania, USA.'}, {'ForeName': 'Sinead A M', 'Initials': 'SAM', 'LastName': 'Boran', 'Affiliation': 'Department of Orthopaedics, Cork University Hospital, Wilton, Ireland.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Guerin', 'Affiliation': 'Department of Orthopaedics, Cork University Hospital, Wilton, Ireland.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Harty', 'Affiliation': 'Department of Orthopaedics, Cork University Hospital, Wilton, Ireland.'}]",Bone & joint open,['10.1302/2633-1462.210.BJO-2021-0121.R1']
1871,34619613,"Walking indoors, outdoors, and on a treadmill: Gait differences in healthy young and older adults.","BACKGROUND


Although human gait is typically studied in a laboratory environment, the findings of laboratory-based gait assessments are often applied to daily life scenarios. Assessing gait in varied conditions may offer a better understanding of the influence of environment on gait performance.
RESEARCH QUESTIONS


How do spatiotemporal gait measures differ between indoor overground walking, outdoor walking, and treadmill walking in healthy adults? Do different walking environments exaggerate age-related alterations in gait performance in older compared to young adults?
METHODS


30 young (18-30yrs) and 28 older adults (60-80yrs) completed four randomized conditions at their typical, comfortable walking pace: 1) 8 m of indoor walking, 2) continuous indoor walking, 3) treadmill walking, and 4) outdoor walking on a sidewalk. Wearable inertial sensors recorded gait data and the magnitudes and variability (in standard deviations) of the following gait measures were computed: cadence, percent double support, stride length (with sample entropy), and gait velocity.
RESULTS


Despite the lack of significant univariate interactions between group and walking condition, significant main effects for condition and group were observed in both the magnitude and variability analyses. Treadmill walking resulted in a slower gait with shorter, less variable strides (p < .001), while walking outdoors resulted in faster gait with longer strides (p < .001) compared to other walking conditions. Stride length regularity was reduced when walking outdoors compared to treadmill walking (p = .019).
SIGNIFICANCE


The results showed that the effects of walking condition on gait measures were more dramatic than participant age, and gait performance differs between walking environments in both older and younger adults. Since daily life gait encompasses both tightly controlled and unconstrained, free-living walking, researchers and clinicians should use caution when generalizing gait performance across walking conditions. Measures of gait performance typically used in laboratory gait analyses may not adequately characterize daily life gait in indoor and outdoor environments.",2021,"Treadmill walking resulted in a slower gait with shorter, less variable strides (p < .001), while walking outdoors resulted in faster gait with longer strides (p < .001) compared to other walking conditions.","['healthy adults', 'healthy young and older adults', '30 young (18-30yrs) and 28 older adults (60-80yrs', 'indoor and outdoor environments']","['indoor walking, 2) continuous indoor walking, 3) treadmill walking, and 4) outdoor walking on a sidewalk']","['stride length (with sample entropy), and gait velocity', 'faster gait with longer strides', 'gait performance', 'Stride length regularity', 'indoor overground walking, outdoor walking, and treadmill walking', 'gait measures', 'slower gait with shorter, less variable strides']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0557772', 'cui_str': 'Sidewalk'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",30.0,0.0358869,"Treadmill walking resulted in a slower gait with shorter, less variable strides (p < .001), while walking outdoors resulted in faster gait with longer strides (p < .001) compared to other walking conditions.","[{'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Schmitt', 'Affiliation': 'Department of Health, Human Performance, and Recreation, University of Arkansas, Fayetteville, AR, USA; Applied Neuromechanics Laboratory, Department of Applied Physiology and Kinesiology, University of Florida, Gainesville, FL 32611, USA. Electronic address: acs063@uark.edu.'}, {'ForeName': 'Sidney T', 'Initials': 'ST', 'LastName': 'Baudendistel', 'Affiliation': 'Applied Neuromechanics Laboratory, Department of Applied Physiology and Kinesiology, University of Florida, Gainesville, FL 32611, USA.'}, {'ForeName': 'Ania L', 'Initials': 'AL', 'LastName': 'Lipat', 'Affiliation': 'Applied Neuromechanics Laboratory, Department of Applied Physiology and Kinesiology, University of Florida, Gainesville, FL 32611, USA.'}, {'ForeName': 'Tatiana A', 'Initials': 'TA', 'LastName': 'White', 'Affiliation': 'Applied Neuromechanics Laboratory, Department of Applied Physiology and Kinesiology, University of Florida, Gainesville, FL 32611, USA.'}, {'ForeName': 'Tiphanie E', 'Initials': 'TE', 'LastName': 'Raffegeau', 'Affiliation': 'Department of Health, Kinesiology, and Recreation at the University of Utah in Salt Lake City, UT, USA; Present address: Division of Execise Physiology, School of Applied Health Sciences and Wellness, Ohio University, Athens, OH, USA.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Hass', 'Affiliation': 'Applied Neuromechanics Laboratory, Department of Applied Physiology and Kinesiology, University of Florida, Gainesville, FL 32611, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2021.09.197']
1872,34619544,Efficacy of color lenses in abolishing photosensitivity: Beyond the one-type-fits-all approach?,"OBJECTIVE


Red-light filtering lenses represent an additional option to medication in photosensitive epilepsy. Blue lenses (Clarlet Z1 F133) can dramatically reduce seizure frequency, with a substantial restriction in luminance that can limit their applicability in daily life. We investigated the efficacy of 4 blue lenses with higher transmittance and reduced chromatic distortion in abolishing the photoparoxysmal EEG response (PPR) compared to the gold-standard Z1 lenses.
METHODS


We reviewed EEG data during photic-and pattern stimulation in 19 consecutive patients (6-39 years) with photosensitivity (PS). Stimulation was performed at baseline and while wearing Z1 and the four new lenses. Lenses were tested in the same session by asking the patient to wear them in a sequentially randomized fashion while stimulating again with the most provocative photic/pattern stimuli. The primary outcome was the change in the initial PPR observed for each lens, categorized as no change, reduction, and abolition.
RESULTS


Photosensitivity was detected in 17 subjects (89.5%); pattern sensitivity (PtS) was identified in 14 patients (73.7%). The highest percentages of PPR abolition/reduction were observed with Z1, for both PS and PtS. Regarding the new lenses, B1 + G1 offered the best rates, followed by B1 + G2. B1 + G3 and B1 showed lower efficacy rates, particularly for PtS. In the comparative analysis, no significant differences in PPR suppression were detected between the five lenses for PS. For PtS, the capacity of Z1 for PPR abolition was significantly higher compared with B1 + G3 and B1.
CONCLUSIONS


This preliminary study suggests efficacy of the new group of blue lenses with potentially greater tolerability, particularly in regions with fewer sunlight hours during winter. In line with the current trend for personalized approach to treatment, this study suggests that in some patients there might be scope in extending the testing to offer the lens with the higher transmittance effective in abolishing the PPR.",2021,"For PtS, the capacity of Z1 for PPR abolition was significantly higher compared with B1 + G3 and B1.
","['abolishing photosensitivity', 'regions with fewer sunlight hours during winter', '19 consecutive patients (6-39\u202fyears) with photosensitivity (PS', 'photosensitive epilepsy']","['Blue lenses (Clarlet Z1 F133', 'color lenses', '4 blue lenses with higher transmittance and reduced chromatic distortion', 'Red-light filtering lenses']","['initial PPR observed for each lens, categorized as no change, reduction, and abolition', 'capacity of Z1 for PPR abolition', 'PPR suppression', 'pattern sensitivity (PtS', 'efficacy rates', 'Photosensitivity', 'PPR abolition/reduction']","[{'cui': 'C0349506', 'cui_str': 'Photosensitivity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0393720', 'cui_str': 'Photogenic epilepsy'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0563227', 'cui_str': 'Red light'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0349506', 'cui_str': 'Photosensitivity'}]",19.0,0.10962,"For PtS, the capacity of Z1 for PPR abolition was significantly higher compared with B1 + G3 and B1.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Checa-Ros', 'Affiliation': 'Aston Institute of Health and Neurodevelopment, College of Health and Life Sciences, Aston University, Birmingham, UK; Departamento de Medicina y Cirugía, Universidad CEU Cardenal Herrera, Valencia, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kasteleijn-Nolst Trenite', 'Affiliation': 'Department of Neurosurgery and Epilepsy, University Medical Center Utrecht, Utrecht, The Netherlands; Nesmos Department, Faculty of Medicine and Psychology, Sapienza Università, Roma, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Edson-Scott', 'Affiliation': 'Aston Institute of Health and Neurodevelopment, College of Health and Life Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Carr', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cerquiglini', 'Affiliation': 'Dipartimento di Scienze e Biotecnologie Medico Chirurgiche, Facoltà di Farmacia e Medicina Polo Pontino, Sapienza Università, Roma, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Seri', 'Affiliation': ""Aston Institute of Health and Neurodevelopment, College of Health and Life Sciences, Aston University, Birmingham, UK; Department of Clinical Neurophysiology, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK. Electronic address: s.seri@aston.ac.uk.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.108332']
1873,34619143,Catheter ablation for persistent atrial fibrillation: A multicenter randomized trial of pulmonary vein isolation (PVI) versus PVI with posterior left atrial wall isolation (PWI) - The CAPLA study.,"BACKGROUND


The success of pulmonary vein isolation (PVI) is reduced in persistent AF (PsAF) compared to paroxysmal AF. Adjunctive ablation strategies have failed to show consistent incremental benefit over PVI alone in randomized studies. The left atrial posterior wall is a potential source of non-PV triggers and atrial substrate which may promote the initiation and maintenance of PsAF. Adding posterior wall isolation (PWI) to PVI had shown conflicting outcomes, with earlier studies confounded by methodological limitations.
OBJECTIVES


To determine whether combining PWI with PVI significantly improves freedom from AF recurrence, compared to PVI alone, in patients with PsAF.
METHODS


This is a multi-center, prospective, international randomized clinical trial. 338 patients with symptomatic PsAF refractory to anti-arrhythmic therapy (AAD) will be randomized to either PVI alone or PVI with PWI in a 1:1 ratio. PVI involves wide antral circumferential pulmonary vein (PV) isolation, utilizing contact force sensing ablation catheters. PWI involves the creation of a floor line connecting the inferior aspect of the PVs, and a roof line connecting the superior aspect of the PVs. Follow up is for a minimum of 12 months with rhythm monitoring via implantable cardiac device and/or loop monitor, or frequent intermittent monitoring with an ECG device. The primary outcome is freedom from any documented atrial arrhythmia of > 30 seconds off AAD at 12 months, after a single ablation procedure.
CONCLUSIONS


This randomized study aims to determine the success and safety of adjunctive PWI to PVI in patients with persistent AF.",2021,"To determine whether combining PWI with PVI significantly improves freedom from AF recurrence, compared to PVI alone, in patients with PsAF.
","['338 patients with symptomatic PsAF refractory to anti-arrhythmic therapy (AAD', 'patients with PsAF', 'patients with persistent AF', 'Persistent Atrial Fibrillation']","['PVI alone or PVI with PWI', 'Catheter Ablation', 'Pulmonary Vein Isolation (PVI) versus PVI with Posterior Left Atrial Wall Isolation (PWI']",['freedom from any documented atrial arrhythmia of > 30 seconds\xa0off AAD'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",338.0,0.0839936,"To determine whether combining PWI with PVI significantly improves freedom from AF recurrence, compared to PVI alone, in patients with PsAF.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chieng', 'Affiliation': 'The Baker Heart and Diabetes Research Institute, Melbourne, Australia; The Alfred Hospital, Melbourne, Australia,; University of Melbourne, Melbourne, Australia; Cabrini Hospital, Melbourne, Australia.'}, {'ForeName': 'Hariharan', 'Initials': 'H', 'LastName': 'Sugumar', 'Affiliation': 'The Baker Heart and Diabetes Research Institute, Melbourne, Australia; The Alfred Hospital, Melbourne, Australia,; University of Melbourne, Melbourne, Australia; Cabrini Hospital, Melbourne, Australia.'}, {'ForeName': 'Liang-Han', 'Initials': 'LH', 'LastName': 'Ling', 'Affiliation': ""The Baker Heart and Diabetes Research Institute, Melbourne, Australia; The Alfred Hospital, Melbourne, Australia,; University of Melbourne, Melbourne, Australia; St Vincent's Private Hospital Fitzroy, Melbourne Australia.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Segan', 'Affiliation': 'The Baker Heart and Diabetes Research Institute, Melbourne, Australia; The Alfred Hospital, Melbourne, Australia,; University of Melbourne, Melbourne, Australia; Cabrini Hospital, Melbourne, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Azzopardi', 'Affiliation': 'The Baker Heart and Diabetes Research Institute, Melbourne, Australia; The Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Prabhu', 'Affiliation': 'The Baker Heart and Diabetes Research Institute, Melbourne, Australia; The Alfred Hospital, Melbourne, Australia,; University of Melbourne, Melbourne, Australia; Mulgrave Private Hospital, Melbourne, Australia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Al-Kaisey', 'Affiliation': 'University of Melbourne, Melbourne, Australia; Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Voskoboinik', 'Affiliation': 'The Baker Heart and Diabetes Research Institute, Melbourne, Australia; The Alfred Hospital, Melbourne, Australia,; University of Melbourne, Melbourne, Australia; Cabrini Hospital, Melbourne, Australia.'}, {'ForeName': 'Ramanathan', 'Initials': 'R', 'LastName': 'Parameswaran', 'Affiliation': 'University of Melbourne, Melbourne, Australia; Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Morton', 'Affiliation': 'University of Melbourne, Melbourne, Australia; Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Bhupesh', 'Initials': 'B', 'LastName': 'Pathik', 'Affiliation': 'University of Melbourne, Melbourne, Australia; Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'McLellan', 'Affiliation': ""University of Melbourne, Melbourne, Australia; Royal Melbourne Hospital, Melbourne, Australia; St Vincent's Private Hospital Fitzroy, Melbourne Australia.""}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'University of Melbourne, Melbourne, Australia; Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'University of Melbourne, Melbourne, Australia; Royal Melbourne Hospital, Melbourne, Australia; Epworth Hospital Richmond, Melbourne, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Finch', 'Affiliation': 'University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Rajeev K', 'Initials': 'RK', 'LastName': 'Pathak', 'Affiliation': 'Canberra Hospital, ACT, Australia; Australian National University, ACT, Australia.'}, {'ForeName': 'Deep Chandh', 'Initials': 'DC', 'LastName': 'Raja', 'Affiliation': 'Canberra Hospital, ACT, Australia; Australian National University, ACT, Australia.'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Sterns', 'Affiliation': 'Royal Jubilee Hospital, Vancouver Island, British Columbia, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Ginks', 'Affiliation': 'John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Monash University, Melbourne, Australia; Curtin University, Perth, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Kalman', 'Affiliation': 'University of Melbourne, Melbourne, Australia; Monash University, Melbourne, Australia; Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Kistler', 'Affiliation': 'The Baker Heart and Diabetes Research Institute, Melbourne, Australia; The Alfred Hospital, Melbourne, Australia,; University of Melbourne, Melbourne, Australia; Cabrini Hospital, Melbourne, Australia; Monash University, Melbourne, Australia; Melbourne Private Hospital, Melbourne, Australia. Electronic address: Peter.kistler@baker.edu.au.'}]",American heart journal,['10.1016/j.ahj.2021.09.015']
1874,34619115,Transition Preparation for Young Adolescents with Congenital Heart Disease: A Clinical Trial.,"OBJECTIVE


To evaluate the impact of a novel nurse-led transition intervention program designed for young adolescents (age 13-14 years) with congenital heart disease (CHD). We hypothesized that the intervention would result in improved self-management skills and CHD knowledge.
STUDY DESIGN


Single-center cluster randomized controlled trial of a nurse-led transition intervention vs usual care. The intervention group received a 1-hour individualized session with a cardiology nurse, focusing on CHD education and self-management. The primary end point was change in TRANSITION-Q (transition readiness) score between baseline and 6 months. The secondary end point was change in MyHeart score (CHD knowledge).
RESULTS


We randomized 60 participants to intervention (n = 30) or usual care (n = 30). TRANSITION-Q score (range 0-100) increased from 49 ± 10 at baseline to 54 ± 9.0 at 6 months (intervention) vs 47 ± 14 to 44 ± 14 (usual care). Adjusted for baseline score, TRANSITION-Q scores at 1 and 6 months were greater in the intervention group (mean difference 5.9, 95% CI 1.3-10.5, P = .01). MyHeart score (range 0-100) increased from 48 ± 24 at baseline to 71 ± 16 at 6 months (intervention) vs 54 ± 24 to 57 ± 22 (usual care). Adjusted for baseline score, MyHeart scores at 1 and 6 months were greater in the intervention group (mean difference 19, 95% CI 12-26, P < .0001). Participants aged 14 years had a greater increase in TRANSITION-Q score at 6 months compared with 13-year-old participants (P < .05).
CONCLUSIONS


A nurse-led program improved transition readiness and CHD knowledge among young adolescents. This simple intervention can be readily adopted in other healthcare settings.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02374892.",2021,"Participants age 14 years had a greater increase in TRANSITION-Q score at 6 months compared with 13-year-olds (P < .05).
","['60 participants to intervention (n=30) or usual care (n=30', 'young adolescents (age 13-14 years) with congenital heart disease (CHD', 'young adolescents', 'Young Adolescents with Congenital Heart Disease']","['Transition Preparation', 'nurse-led transition intervention versus usual care', '1-hour individualized session with a cardiology nurse, focusing on CHD education and self-management', 'novel nurse-led transition intervention program']","['transition readiness and CHD knowledge', 'Q score', 'change in TRANSITION-Q (transition readiness) score', 'change in MyHeart score (CHD knowledge']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",60.0,0.0945942,"Participants age 14 years had a greater increase in TRANSITION-Q score at 6 months compared with 13-year-olds (P < .05).
","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada; Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada; Stollery Children's Hospital, Edmonton, Alberta, Canada. Electronic address: andrew.mackie@ualberta.ca.""}, {'ForeName': 'Kathryn N', 'Initials': 'KN', 'LastName': 'Rankin', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Maryna', 'Initials': 'M', 'LastName': 'Yaskina', 'Affiliation': ""Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Gingrich', 'Affiliation': ""Stollery Children's Hospital, Edmonton, Alberta, Canada.""}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': ""Stollery Children's Hospital, Edmonton, Alberta, Canada.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Schuh', 'Affiliation': ""Stollery Children's Hospital, Edmonton, Alberta, Canada.""}, {'ForeName': 'Adrienne H', 'Initials': 'AH', 'LastName': 'Kovacs', 'Affiliation': 'Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nicholas', 'Affiliation': 'Faculty of Social Work, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gwen R', 'Initials': 'GR', 'LastName': 'Rempel', 'Affiliation': 'Faculty of Health Disciplines, Athabasca University, Athabasca, Alberta, Canada.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2021.09.053']
1875,34618513,Therapist-level moderation of within- and between-therapist process-outcome associations.,"OBJECTIVE


Although higher quality patient-therapist alliance and more positive patient outcome expectation (OE) consistently predict symptomatic/functional improvement in psychotherapy, most research has failed to capture the nuance in these process-outcome relations by parsing them into  within-therapist  (i.e., differences between patients treated by the same therapist) and  between-therapist  (i.e., differences between therapists' average process/outcome ratings across all patients in their caseloads) components. Moreover, the few studies that have done so have produced mixed results, suggesting the possibility of systematic variability in these associations (i.e., moderators). One potential source of such variability could be providers themselves; that is, different therapists could use these processes to differing therapeutic benefit. This study tested the alliance- and OE-outcome associations at both the within- and between-therapist levels and explored therapist-level moderators of them.
METHOD


Data derived from 212 adult outpatients treated naturalistically by 42 psychotherapists as part of a randomized trial that compared different case-assignment methods. Patients completed measures of alliance, OE, and outcome repeatedly throughout treatment. Therapist characteristics were assessed at baseline.
RESULTS


Multilevel structural equation models revealed that, at the between-therapist level, only higher alliance quality, but not more optimistic OE, was associated with greater caseload-level improvement. At the within-therapist level, only more optimistic OE, but not higher alliance quality, was associated with patient improvement. Finally, therapists' self-perceived alliance-fostering effectiveness and cognitive-behavioral orientation moderated the within- and between-therapist alliance-outcome associations, respectively.
CONCLUSION


Results indicate that different therapists use common treatment processes to differing therapeutic benefit, which can inform more personalized clinical practices and trainings. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"At the within-therapist level, only more optimistic OE, but not higher alliance quality, was associated with patient improvement.",['212 adult outpatients treated naturalistically by 42 psychotherapists as part of a randomized trial that compared different case-assignment methods'],[],"['optimistic OE', 'alliance quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0557555', 'cui_str': 'Psychotherapist'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],"[{'cui': 'C0564470', 'cui_str': 'Optimistic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",212.0,0.0911043,"At the within-therapist level, only more optimistic OE, but not higher alliance quality, was associated with patient improvement.","[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Coyne', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Kraus', 'Affiliation': 'Outcome Referrals, Inc.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000676']
1876,34623318,Adaptation and Assessment of a Text Messaging Smoking Cessation Intervention in Vietnam: Pilot Randomized Controlled Trial.,"BACKGROUND


Text message (ie, short message service, SMS) smoking cessation interventions have demonstrated efficacy in high-income countries but are less well studied in low- and middle-income countries, including Vietnam.
OBJECTIVE


The goal of the research is to assess the feasibility, acceptability, and preliminary efficacy of a fully automated bidirectional SMS cessation intervention adapted for Vietnamese smokers.
METHODS


The study was conducted in 3 phases. In phase 1, we adapted the SMS library from US-based SMS cessation programs (ie, SmokefreeTXT and Text2Quit). The adaptation process consisted of 7 focus groups with 58 smokers to provide data on culturally relevant patterns of tobacco use and assess message preferences. In phase 2, we conducted a single-arm pilot test of the SMS intervention with 40 smokers followed by in-depth interviews with 10 participants to inform additional changes to the SMS library. In phase 3, we conducted a 2-arm pilot randomized controlled trial (RCT) with 100 smokers. Participants received either the SMS program (intervention; n=50) or weekly text assessment on smoking status (control; n=50). The 6-week SMS program consisted of a 2-week prequit period and a 4-week postquit period. Participants received 2 to 4 automated messages per day. The main outcomes were engagement and acceptability which were assessed at 6 weeks (end of intervention). We assessed biochemically confirmed smoking abstinence at 6 weeks and 12 weeks. Postintervention in-depth interviews explored user experiences among a random sample of 16 participants in the intervention arm.
RESULTS


Participants in both arms reported high levels of engagement and acceptability. Participants reported using the program for an average of 36.4 (SD 3.4) days for the intervention arm and 36.0 (SD 3.9) days for the control arm. Four of the 50 participants in the intervention arm (8%) reset the quit date and 19 (38%) texted the keyword TIPS. The majority of participants in both arms reported that they always or usually read the text messages. Compared to the control arm, a higher proportion of participants in the intervention arm reported being satisfied with the program (98% [49/50] vs 82% [41/50]). Biochemically verified abstinence was higher in the intervention arm at 6 weeks (20% [10/50] vs 2% [1/50]; P=.01), but the effect was not significant at 12 weeks (12% [6/50] vs 6% [3/50]; P=.49). In-depth interviews conducted after the RCT suggested additional modifications to enhance the program including tailoring the timing of messages, adding more opportunities to interact with the program, and placing a greater emphasis on messages that described the harms of smoking.
CONCLUSIONS


The study supported the feasibility and acceptability of an SMS program adapted for Vietnamese smokers. Future studies need to assess whether, with additional modifications, the program is associated with prolonged abstinence.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03219541; https://clinicaltrials.gov/ct2/show/NCT03219541.",2021,"Biochemically verified abstinence was higher in the intervention arm at 6 weeks (20% [10/50] vs 2% [1/50]; P=.01), but the effect was not significant at 12 weeks (12% [6/50] vs 6% [3/50]; P=.49).","['16 participants in the intervention arm', '100 smokers', 'Vietnam', 'Vietnamese smokers', '40 smokers followed by in-depth interviews with 10 participants to inform additional changes to the SMS library']","['SMS intervention', 'SMS program (intervention; n=50) or weekly text assessment on smoking status', 'Text Messaging Smoking Cessation Intervention', 'SMS program', 'fully automated bidirectional SMS cessation intervention']","['smoking abstinence', 'high levels of engagement and acceptability', 'feasibility and acceptability']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023621', 'cui_str': 'Library'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.138393,"Biochemically verified abstinence was higher in the intervention arm at 6 weeks (20% [10/50] vs 2% [1/50]; P=.01), but the effect was not significant at 12 weeks (12% [6/50] vs 6% [3/50]; P=.49).","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Population Health, Grossman School of Medicine, New York University, New York, NY, United States.'}, {'ForeName': 'Nam', 'Initials': 'N', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Siman', 'Affiliation': 'Ronald O Perelman Department of Emergency Medicine, Grossman School of Medicine, New York University, New York, NY, United States.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Cleland', 'Affiliation': 'Department of Population Health, Grossman School of Medicine, New York University, New York, NY, United States.'}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Hue Thi', 'Initials': 'HT', 'LastName': 'Doan', 'Affiliation': 'Thai Nguyen University of Medicine and Pharmacy, Thai Nguyen, Vietnam.'}, {'ForeName': 'Lorien C', 'Initials': 'LC', 'LastName': 'Abroms', 'Affiliation': 'Milken Institute School of Public Health, George Washington University, Washington, DC, United States.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Shelley', 'Affiliation': 'School of Global Public Health, New York University, New York, NY, United States.'}]",JMIR mHealth and uHealth,['10.2196/27478']
1877,34623308,Using Electronic Health Record-Based Clinical Decision Support to Provide Social Risk-Informed Care in Community Health Centers: Protocol for the Design and Assessment of a Clinical Decision Support Tool.,"BACKGROUND


Consistent and compelling evidence demonstrates that social and economic adversity has an impact on health outcomes. In response, many health care professional organizations recommend screening patients for experiences of social and economic adversity or social risks-for example, food, housing, and transportation insecurity-in the context of care. Guidance on how health care providers can act on documented social risk data to improve health outcomes is nascent. A strategy recommended by the National Academy of Medicine involves using social risk data to adapt care plans in ways that accommodate patients' social risks.
OBJECTIVE


This study's aims are to develop electronic health record (EHR)-based clinical decision support (CDS) tools that suggest social risk-informed care plan adaptations for patients with diabetes or hypertension, assess tool adoption and its impact on selected clinical quality measures in community health centers, and examine perceptions of tool usability and impact on care quality.
METHODS


A systematic scoping review and several stakeholder activities will be conducted to inform development of the CDS tools. The tools will be pilot-tested to obtain user input, and their content and form will be revised based on this input. A randomized quasi-experimental design will then be used to assess the impact of the revised tools. Eligible clinics will be randomized to a control group or potential intervention group; clinics will be recruited from the potential intervention group in random order until 6 are enrolled in the study. Intervention clinics will have access to the CDS tools in their EHR, will receive minimal implementation support, and will be followed for 18 months to evaluate tool adoption and the impact of tool use on patient blood pressure and glucose control.
RESULTS


This study was funded in January 2020 by the National Institute on Minority Health and Health Disparities of the National Institutes of Health. Formative activities will take place from April 2020 to July 2021, the CDS tools will be developed between May 2021 and November 2022, the pilot study will be conducted from August 2021 to July 2022, and the main trial will occur from December 2022 to May 2024. Study data will be analyzed, and the results will be disseminated in 2024.
CONCLUSIONS


Patients' social risk information must be presented to care teams in a way that facilitates social risk-informed care. To our knowledge, this study is the first to develop and test EHR-embedded CDS tools designed to support the provision of social risk-informed care. The study results will add a needed understanding of how to use social risk data to improve health outcomes and reduce disparities.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/31733.",2021,Eligible clinics will be randomized to a control group or potential intervention group; clinics will be recruited from the potential intervention group in random order until 6 are enrolled in the study.,"['2021 and November 2022, the pilot study will be conducted from August 2021 to July 2022, and the main trial will occur from December 2022 to May 2024', 'patients with diabetes or hypertension', 'group; clinics will be recruited from the potential intervention group in random order until 6 are enrolled in the study', 'funded in January 2020 by the National Institute on Minority Health and Health Disparities of the National Institutes of Health', 'Community Health Centers']","['control group or potential intervention', 'electronic health record (EHR)-based clinical decision support (CDS']",[],"[{'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1955955', 'cui_str': 'Minority Health'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}]",[],,0.0562795,Eligible clinics will be randomized to a control group or potential intervention group; clinics will be recruited from the potential intervention group in random order until 6 are enrolled in the study.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Gold', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sheppler', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Arwen', 'Initials': 'A', 'LastName': 'Bunce', 'Affiliation': 'OCHIN, Inc., Portland, OR, United States.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Cottrell', 'Affiliation': 'OCHIN, Inc., Portland, OR, United States.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Yosuf', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Pisciotta', 'Affiliation': 'OCHIN, Inc., Portland, OR, United States.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Gunn', 'Affiliation': 'OCHIN, Inc., Portland, OR, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Leo', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gottlieb', 'Affiliation': 'University of California San Francisco, San Francisco, CA, United States.'}]",JMIR research protocols,['10.2196/31733']
1878,34622548,Efficacy and safety of oral semaglutide by baseline age in Japanese patients with type 2 diabetes: A subgroup analysis of the PIONEER 9 and 10 Japan trials.,"A post-hoc exploratory analysis of the PIONEER 9 and 10 trials evaluated the effect of baseline age (<65 and ≥65 years) on the efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes. In PIONEER 9 and 10, patients were randomized to once-daily oral semaglutide (3, 7 or 14 mg) or a comparator (placebo or once-daily subcutaneous liraglutide 0.9 mg [PIONEER 9]; once-weekly subcutaneous dulaglutide 0.75 mg [PIONEER 10]) for 52 weeks, with 5 weeks' follow-up. In total, 701 patients were included (PIONEER 9: N = 243; PIONEER 10: N = 458). Glycaemic efficacy of oral semaglutide was similar in Japanese patients aged <65 years compared with those ≥65 years, and there did not appear to be a clear pattern between age subgroup and body weight changes. Across treatment arms, adverse events generally occurred in greater proportions of patients aged ≥65 versus <65 years. There was generally a higher rate of premature trial product discontinuation because of adverse events in the older age group. These results indicate that oral semaglutide is efficacious in Japanese patients irrespective of age.",2021,"Across treatment arms, adverse events (AEs) generally occurred in greater proportions of patients aged ≥65 versus <65 years.","['Japanese patients aged <65\u2009years', '701 patients were included (PIONEER 9: N=243', 'Japanese patients with type 2 diabetes', 'Japanese patients irrespective of age']","['oral semaglutide', 'comparator (placebo or once-daily subcutaneous liraglutide 0.9 mg [PIONEER 9]; once-weekly subcutaneous dulaglutide']","['Glycaemic efficacy', 'efficacy and safety of oral semaglutide', 'Efficacy and safety', 'adverse events (AEs']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",701.0,0.186511,"Across treatment arms, adverse events (AEs) generally occurred in greater proportions of patients aged ≥65 versus <65 years.","[{'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yabe', 'Affiliation': 'Department of Diabetes and Endocrinology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Christin Løth', 'Initials': 'CL', 'LastName': 'Hertz', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Horio', 'Affiliation': 'Novo Nordisk Pharma Ltd, Tokyo, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Nagakute, Aichi, Japan.'}, {'ForeName': 'Anne Møller', 'Initials': 'AM', 'LastName': 'Nielsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Seino', 'Affiliation': 'Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14571']
1879,34624757,Fixed dose combination of capecitabine and cyclophosphamide in metastatic breast cancer: Results from THE ENCLOSE phase 2/3 randomized multicenter study.,"AIM


To evaluate pharmacokinetics, efficacy and safety of fixed-dose combination (FDC) of oral capecitabine + cyclophosphamide in metastatic breast cancer (MBC) patients progressing after anthracycline and/or taxane chemotherapy.
METHODS


In this prospective, adaptive, phase-2/3, open-label study (CTRI/2014/12/005234), patients were randomized (1:1:1) to three FDC doses (doses/day: D1, capecitabine + cyclophosphamide 1400 mg + 60 mg; D2, 1800 mg + 80 mg; D3, 2200 mg + 100 mg) for 14 days, in 21-day cycles. In Part-I, multiple-dose pharmacokinetics and optimal dose(s) were evaluated with futility analysis. Group(s) with <3 responders based on best overall response rate (BOR, complete response [CR]+partial response [PR]), were discontinued. Efficacy (BOR, disease control rates [DCR; CR + PR + stable disease]) and safety of optimal dose(s) were evaluated in Part-II.
RESULTS


Of 66 patients (n = 22/group) in Part-I, pharmacokinetics (D1 = 7/22, D2 = 9/22, D3 = 8/22) showed dose-proportionality for cyclophosphamide and greater than dose-proportionality for capecitabine. Modified intent-to-treat (mITT) analysis showed BOR of 7.14% (1/14) in D1 (discontinued), and 22.22% (4/18) each in D2 and D3, respectively. In Part-II, 50 additional patients were randomized in D2 and D3 (n = 144; total 72 [22 + 50] patients/group). mITT analysis in D2 (n = 54) and D3 (n = 58) showed BOR of 29.63% (16/54, 95%CI: 17.45-41.81%) and 22.41% (13/58, 95%CI: 11.68-33.15%), respectively. DCR in D2 and D3 were 87.04% (47/54, 95%CI: 78.08-96.00%) and 82.76% (48/58; 95%CI: 73.04-92.48%) after 3 and 57.41% (31/54; 95%CI: 52.41-79.50%) and 50.00% (29/58; 95%CI: 40.40-67.00%), after 6-cycles, respectively. Hand-foot syndrome (16.67%), vomiting (9.72%) in D2, and hand-foot syndrome (18.06%), asthenia (15.28%) in D3 were most-common adverse events.
CONCLUSION


FDC of capecitabine + cyclophosphamide (1800 + 80 mg/day) showed high disease control rates and good safety profile in MBC patients.",2021,"DCR in D2 and D3 were 87.04% (47/54, 95%CI: 78.08-96.00%) and 82.76% (48/58; 95%CI: 73.04-92.48%) after 3 and 57.41% (31/54; 95%CI: 52.41-79.50%) and 50.00% (29/58; 95%CI: 40.40-67.00%), after 6-cycles, respectively.","['66 patients (n\xa0=\xa022/group) in Part-I, pharmacokinetics', 'metastatic breast cancer', 'metastatic breast cancer (MBC) patients progressing after anthracycline and/or taxane chemotherapy']","['fixed-dose combination (FDC) of oral capecitabine\xa0+\xa0cyclophosphamide', 'capecitabine and cyclophosphamide', 'capecitabine\xa0+\xa0cyclophosphamide', 'cyclophosphamide', 'capecitabine\xa0+\xa0cyclophosphamide ', 'capecitabine']","['vomiting', 'DCR in D2 and D3', 'asthenia', 'pharmacokinetics, efficacy and safety', 'Efficacy (BOR, disease control rates [DCR; CR\xa0+\xa0PR\xa0+\xa0stable disease]) and safety of optimal dose(s', 'high disease control rates and good safety profile', 'overall response rate (BOR, complete response [CR]+partial response [PR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",50.0,0.0567534,"DCR in D2 and D3 were 87.04% (47/54, 95%CI: 78.08-96.00%) and 82.76% (48/58; 95%CI: 73.04-92.48%) after 3 and 57.41% (31/54; 95%CI: 52.41-79.50%) and 50.00% (29/58; 95%CI: 40.40-67.00%), after 6-cycles, respectively.","[{'ForeName': 'Sudeep', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, 400012, Maharashtra, India. Electronic address: sudeepgupta04@yahoo.com.'}, {'ForeName': 'Ghanashyam', 'Initials': 'G', 'LastName': 'Biswas', 'Affiliation': 'Sparsh Hospital and Critical Care Pvt. Ltd., Bhubaneshwar, 751007, Odisha, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': 'Life Care Hospital, Bangalore, 560029, Karnataka, India.'}, {'ForeName': 'Tanveer M', 'Initials': 'TM', 'LastName': 'Maksud', 'Affiliation': 'Unique Hospital - Multispeciality & Research Institute, Surat, 395002, Gujarat, India.'}, {'ForeName': 'Kuntegowdennahalli C', 'Initials': 'KC', 'LastName': 'Lakshmaiah', 'Affiliation': 'Srinivasam Cancer Care Hospitals India Pvt. Ltd., Bangalore, 560076, Karnataka, India.'}, {'ForeName': 'Jayanti G', 'Initials': 'JG', 'LastName': 'Patel', 'Affiliation': 'Apple Hospital, Surat, 395002, Gujarat, India.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Raja', 'Affiliation': 'Madras Medical College and Rajiv Gandhi Govt. General Hospital, Chennai, 600003, Tamil Nadu, India.'}, {'ForeName': 'Rakesh R', 'Initials': 'RR', 'LastName': 'Boya', 'Affiliation': 'Mahatma Gandhi Cancer Hospital & Research Institute, Visakhapatnam, 530017, Andhra Pradesh, India.'}, {'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Patil', 'Affiliation': 'Kailash Cancer Hospital & Research Centre, Vadodara, 391760, Gujarat, India.'}, {'ForeName': 'Kakali', 'Initials': 'K', 'LastName': 'Choudhury', 'Affiliation': 'Health Point Hospital, Kolkata, 700025, West Bengal, India.'}, {'ForeName': 'Shailesh A', 'Initials': 'SA', 'LastName': 'Bondarde', 'Affiliation': 'Shatabdi Superspeciality Hospital, Nashik, 422005, Maharashtra, India.'}, {'ForeName': 'Rakesh S', 'Initials': 'RS', 'LastName': 'Neve', 'Affiliation': ""P.D.E.A's Ayurved Rugnalay & Sterling Multispeciality Hospital, Pune, 411044, Maharashtra, India.""}, {'ForeName': 'Guruprasad', 'Initials': 'G', 'LastName': 'Bhat', 'Affiliation': 'Mallikatta Neuro Centre, Mangalore, 575003, Karnataka, India.'}, {'ForeName': 'Gopichand', 'Initials': 'G', 'LastName': 'Mamillapalli', 'Affiliation': 'City Cancer Centre, Vijayawada, 520002, Andhra Pradesh, India.'}, {'ForeName': 'Apurva A', 'Initials': 'AA', 'LastName': 'Patel', 'Affiliation': 'The Gujarat Cancer & Research Institute (M.P. Shah Cancer Hospital), Ahmedabad, 380016, Gujarat, India.'}, {'ForeName': 'Piyush', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Medical Affairs and Clinical Development, Intas Pharmaceuticals Ltd., Ahmedabad, 380054, Gujarat, India.'}, {'ForeName': 'Nisarg', 'Initials': 'N', 'LastName': 'Joshi', 'Affiliation': 'Medical Affairs and Clinical Development, Intas Pharmaceuticals Ltd., Ahmedabad, 380054, Gujarat, India.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Bajaj', 'Affiliation': 'Medical Affairs and Clinical Development, Intas Pharmaceuticals Ltd., Ahmedabad, 380054, Gujarat, India.'}, {'ForeName': 'Mujtaba A', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Medical Affairs and Clinical Development, Intas Pharmaceuticals Ltd., Ahmedabad, 380054, Gujarat, India.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2021.09.012']
1880,34624665,The effectiveness of affective compared to neutral working memory training in university students with test anxiety.,"BACKGROUND


Test anxiety (TA), defined as the emotional, physiological, and behavioural responses surrounding situations involving formal evaluation of performance, is a relatively common occurrence, and, when present, can be a disruptive factor in students' academic careers. Research indicates that working memory, in particular, affective working memory, is impaired in individuals with TA. The current study therefore explored whether training the application of working memory in affective contexts could reduce TA and associated cognitive and affective impairments.
METHOD


60 Iranian university students (50% female; 19-22 years) with TA symptoms were randomized to receive 20 sessions of affective working memory training (aWMT), neutral working memory training (nWMT) or to a no-training control group. Prior and immediately after training, all participants completed measures of TA, working memory, cognitive control, and emotion regulation.
RESULTS


Compared to the control group, both the aWMT and the nWMT groups demonstrated improved cognitive and affective functioning from pre-to post-training. However, the reduction in TA symptoms and improvement in emotion regulation was greater in the aWMT group compared to the nWMT group.
CONCLUSION


aWMT may be an effective means of not only reducing TA, but also enhancing cognitive and affective functioning. These preliminary findings are promising given the potential for free and easy dissemination of aWMT in schools and online settings, including low- and middle-income countries.",2021,"Compared to the control group, both the aWMT and the nWMT groups demonstrated improved cognitive and affective functioning from pre-to post-training.","['university students with test anxiety', 'individuals with TA', '60 Iranian university students (50% female; 19-22 years) with TA symptoms']","['aWMT', 'neutral working memory training', 'nWMT', '20 sessions of affective working memory training (aWMT), neutral working memory training (nWMT) or to a no-training control group']","['TA symptoms and improvement in emotion regulation', 'TA, working memory, cognitive control, and emotion regulation', 'cognitive and affective functioning']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0103188,"Compared to the control group, both the aWMT and the nWMT groups demonstrated improved cognitive and affective functioning from pre-to post-training.","[{'ForeName': 'Savannah', 'Initials': 'S', 'LastName': 'Minihan', 'Affiliation': 'University of New South Wales, School of Psychology, Developmental Affective Science Lab, Australia.'}, {'ForeName': 'Zobair', 'Initials': 'Z', 'LastName': 'Samimi', 'Affiliation': 'International University of Chabahar, Department of Educational Science, Chabahar, Iran.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Schweizer', 'Affiliation': 'University of New South Wales, School of Psychology, Developmental Affective Science Lab, Australia; University of Cambridge, Department of Psychology, Developmental Cognitive Neuroscience Group, UK. Electronic address: ss816@cam.ac.uk.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103974']
1881,34624624,Pre-treatment hippocampal functioning impacts context renewal for cholinergic modulated exposure therapy.,"Our recent trial demonstrated individuals suffering from social anxiety with performance-related concerns who received virtual reality exposure augmented with scopolamine, a cholinergic antagonist, experienced significantly less post-treatment context renewal (CX) than placebo (Craske et al., 2019). The purpose of the present investigation was to determine who specifically benefits from scopolamine by examining hippocampal (HPC) functioning as a moderator of treatment response (Placebo n = 15, SCOP 0.5 mg n = 15, SCOP 0.6 mg n = 15). Skin conductance response to conditional stimulus (SCR-to-CS) termination suggested a dose-response relationship for enhanced HPC functioning individuals, wherein individuals receiving scopolamine demonstrated less fear at CX. In addition, SCR-to-CS onset indicated reduced fear at CX for impaired HPC individuals receiving SCOP 0.5 mg and SCOP 0.6 mg relative to Placebo. Our findings, however, lacked consistency across measures. Scopolamine remains a promising agent and additional research required to further understand its effects.",2021,"Skin conductance response to conditional stimulus (SCR-to-CS) termination suggested a dose-response relationship for enhanced HPC functioning individuals, wherein individuals receiving scopolamine demonstrated less fear at CX.",['individuals suffering from social anxiety with performance-related concerns who received'],"['virtual reality exposure augmented with scopolamine', 'Placebo', 'SCOP', 'Scopolamine', 'scopolamine', 'conditional stimulus (SCR-to-CS', 'placebo', 'Placebo n = 15, SCOP 0.5 mg n = 15, SCOP']",['Skin conductance response'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",,0.0590631,"Skin conductance response to conditional stimulus (SCR-to-CS) termination suggested a dose-response relationship for enhanced HPC functioning individuals, wherein individuals receiving scopolamine demonstrated less fear at CX.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Sewart', 'Affiliation': 'California State University, Dominguez Hills, Department of Psychology, 1000 East Victoria Street, Carson, CA 90747, United States. Electronic address: asewart@csudh.edu.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'McGlade', 'Affiliation': 'University of California, Los Angeles, Department of Psychology, 1285 Franz Hall, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Treanor', 'Affiliation': 'University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, 757 Westwood Plaza, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fanselow', 'Affiliation': 'University of California, Los Angeles, Department of Psychology, 1285 Franz Hall, Los Angeles, CA 90095, United States; University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, 757 Westwood Plaza, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Craske', 'Affiliation': 'University of California, Los Angeles, Department of Psychology, 1285 Franz Hall, Los Angeles, CA 90095, United States; University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, 757 Westwood Plaza, Los Angeles, CA 90095, United States.'}]",Biological psychology,['10.1016/j.biopsycho.2021.108167']
1882,34626672,Do Extremely Low Gestational Age Neonates Regulate Iron Absorption via Hepcidin?,"OBJECTIVES


To evaluate whether extremely preterm infants regulate iron status via hepcidin.
STUDY DESIGN


In this retrospective analysis of infants from the Preterm Epo Neuroprotection (PENUT) Trial, urine hepcidin (Uhep) normalized to creatinine (Uhep/UCr) was evaluated among infants randomized to erythropoietin (Epo) or placebo.
RESULTS


The correlation (r) between Uhep/UCr and serum markers of iron status (ferritin and zinc protoporphyrin-to-heme ratio [ZnPP/H]) and iron dose was assessed. A total of 243 urine samples from 76 infants born at 24-27 6/7  weeks gestation were analyzed. The median Uhep/UCr concentration was 0.3, 1.3, 0.4, and 0.1 ng/mg at baseline, 2 weeks, 4 weeks, and 12 weeks, respectively, in placebo-treated infants. The median Uhep/UCr value in Epo-treated infants were not significantly different, with the exception of the value at the 2-week time point (median Uhep/UCr, 0.1 ng/mg; P < .001). A significant association was seen between Uhep/UCr and ferritin at 2 weeks (r = 0.63; P < .001) and at 4 weeks (r = 0.41; P = .01) and between Uhep/UCr and ZnPP/H at 2 weeks (r = -0.49; P = .002).
CONCLUSIONS


Uhep/UCr values correlate with serum iron markers. Uhep/UCr values vary over time and are affected by treatment with Epo, suggesting that extremely preterm neonates can regulate hepcidin and therefore their iron status. Uhep is suppressed in extremely preterm neonates, particularly those treated with Epo.",2021,The correlation (r) between Uhep/UCr and serum markers of iron status (ferritin and zinc protoporphyrin-to-heme ratio (ZnPP/H)) and iron dose was assessed.,"['A total of 243 urine samples from 76 infants born at 24-27 6/7 weeks gestation were analyzed', 'extremely preterm infants regulate iron status via hepcidin', 'infants from the Preterm Epo Neuroprotection (PENUT) Trial']",['erythropoietin (Epo) or placebo'],"['Median Uhep/UCr values', 'serum markers of iron status (ferritin and zinc protoporphyrin-to-heme ratio (ZnPP/H)) and iron dose']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0598958', 'cui_str': 'Neuron Protection'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0078791', 'cui_str': 'Zinc protoporphyrin'}, {'cui': 'C0018966', 'cui_str': 'Heme'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.142669,The correlation (r) between Uhep/UCr and serum markers of iron status (ferritin and zinc protoporphyrin-to-heme ratio (ZnPP/H)) and iron dose was assessed.,"[{'ForeName': 'Kendell R', 'Initials': 'KR', 'LastName': 'German', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA. Electronic address: germank@uw.edu.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, Children's Hospital of San Antonio, San Antonio, TX.""}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Whittington', 'Affiliation': 'Department of Medicinal Chemistry, University of Washington, Seattle, WA.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Bahr', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2021.09.059']
1883,34626891,Effects of internet-delivered eating disorder prevention on reward-based eating drive: A randomized controlled trial.,"OBJECTIVE


This study is a secondary analysis testing the effects of an internet eating disorder prevention program on reward-based eating drive in a high-risk sample of college-aged women.
METHOD


We analyzed data from 278 women who were randomized to internet dissonance-based intervention (DBI-I), internet cognitive-behavioral treatment (CBTI), or no intervention (NI). Both active conditions consisted of self-guided activities completed over the course of four weeks. Linear mixed effects modeling was used to test the effect of internet intervention on reward-based eating drive.
RESULTS


DBI-I was associated with greater reductions in reward-based eating over time than NI. No other Condition × Time effects were found.
DISCUSSION


The results provide preliminary support for DBI-I as a strategy for reducing reward-based eating drive in a high-risk population relative to no intervention.",2021,DBI-I was associated with greater reductions in reward-based eating over time than NI.,"['college-aged women', '278 women who were randomized to']","['internet intervention', 'internet eating disorder prevention program', 'internet dissonance-based intervention (DBI-I), internet cognitive-behavioral treatment (CBTI), or no intervention (NI', 'internet-delivered eating disorder prevention']",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]",[],278.0,0.0578605,DBI-I was associated with greater reductions in reward-based eating over time than NI.,"[{'ForeName': 'Taona P', 'Initials': 'TP', 'LastName': 'Haderlein', 'Affiliation': 'VA Greater Los Angeles Healthcare System, Center for the Study of Healthcare Innovation, Implementation, and Policy, United States of America. Electronic address: taona.haderlein@va.gov.'}, {'ForeName': 'A Janet', 'Initials': 'AJ', 'LastName': 'Tomiyama', 'Affiliation': 'University of California, Los Angeles, United States of America.'}]",Eating behaviors,['10.1016/j.eatbeh.2021.101572']
1884,34626890,Implementation of In vivo exposure therapy to decrease injury-related fear in females with a history of ACL-Reconstruction: A pilot study.,"OBJECTIVE


The objective of this pilot study was to examine the preliminary feasibility and efficacy of in vivo exposure therapy (IVET) to decrease injury-related fear in females with history of ACLR.
DESIGN


Pilot Study.
SETTING


Sports Medicine Research Laboratory.
PARTICIPANTS


12 female participants with history of ACLR (≥ 1 year post-operative) were randomized into a 5-week IVET group (n = 6) or 5-week sham physical activity (PA) monitoring group (n = 6).
MAIN OUTCOME MEASURES


The independent variables were Group and Time. The dependent variables were the Photographic Series of Sports Activities for ACLR (PHOSA-ACLR) and the Tampa Scale of Kinesiophobia-11 (TSK-11) scores. A Group x Time repeated measures two-way analysis of variance was completed for the PHOSA-ACLR and the TSK-11. Partial η 2  effect sizes were used to examine clinically meaningful differences.
RESULTS


High retention and adherence rates were observed in the intervention group. The PHOSA-ACLR exhibited a significant main effect for Time (F 1,10  = 9.92, p = 0.01, partial η 2  = 0.50), but not for Group. No statistically significant or clinically meaningful differences were observed for the TSK-11.
CONCLUSION


Both groups exhibited decreased injury-related fear for specific functional tasks. Future research should further examine the efficacy of IVET and PA monitoring to decrease injury-related fear in patients after ACLR.",2021,"No statistically significant or clinically meaningful differences were observed for the TSK-11.
CONCLUSION


Both groups exhibited decreased injury-related fear for specific functional tasks.","['females with history of ACLR', '12 female participants with history of ACLR (≥ 1 year post-operative', 'females with a history of ACL-Reconstruction', 'patients after ACLR']","['IVET group (n\xa0=\xa06) or 5-week sham physical activity (PA) monitoring group (n\xa0=\xa06', 'vivo exposure therapy', 'vivo exposure therapy (IVET']","['injury-related fear for specific functional tasks', 'High retention and adherence rates', 'Photographic Series of Sports Activities for ACLR (PHOSA-ACLR) and the Tampa Scale of Kinesiophobia-11 (TSK-11) scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",12.0,0.0203224,"No statistically significant or clinically meaningful differences were observed for the TSK-11.
CONCLUSION


Both groups exhibited decreased injury-related fear for specific functional tasks.","[{'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Baez', 'Affiliation': 'Department of Kinesiology at Michigan State University in East Lansing, Michigan, USA. Electronic address: baezshel@msu.edu.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cormier', 'Affiliation': 'Department of Kinesiology and Health Promotion at the University of Kentucky in Lexington, Kentucky, USA. Electronic address: marc.cormier@uky.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Andreatta', 'Affiliation': 'Department of Communication Sciences and Disorders at the University of Kentucky in Lexington, Kentucky, USA. Electronic address: richard.andreatta@uky.edu.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Gribble', 'Affiliation': 'Department of Athletic Training and Clinical Nutrition at the University of Kentucky in Lexington, Kentucky, USA. Electronic address: phillip.gribble@uky.edu.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Hoch', 'Affiliation': 'Department of Athletic Training and Clinical Nutrition at the University of Kentucky in Lexington, Kentucky, USA. Electronic address: Johanna.Hoch@uky.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.09.009']
1885,34629442,"Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study.","OBJECTIVE


To evaluate the safety and exploratory efficacy of intratympanic administration of OTO-313 in patients with tinnitus.
STUDY DESIGN


Single intratympanic injection of OTO-313 evaluated in a randomized, double-blind, placebo-controlled Phase 1/2 clinical study.
SETTING


Tertiary referral centers.
PATIENTS


Patients with unilateral tinnitus (moderate-severe) with tinnitus duration 1 to 6 months.
INTERVENTIONS


Intratympanic OTO-313.
MAIN OUTCOME MEASURES


Safety and change from baseline in tinnitus functional index (TFI), daily ratings of tinnitus loudness and annoyance, and patient global impression of change (PGIC).
RESULTS


OTO-313 was well-tolerated with lower incidence of adverse events than placebo. Mean TFI reduction from baseline favored OTO-313 at Week 2, 4, and 8. A clinically meaningful, 13-point improvement on the TFI was observed in 43% (6/14) of OTO-313 patients at both Weeks 4 and 8 versus 13% (2/16) of placebo patients (ad hoc responder analysis, p-value < 0.05). Reductions in daily ratings of tinnitus loudness and annoyance favored OTO-313 compared with placebo. In OTO-313 responders, a strong correlation existed between change from baseline in TFI score and changes in tinnitus loudness, tinnitus annoyance, and PGIC.
CONCLUSIONS


OTO-313 was well-tolerated and demonstrated a higher proportion of responders than placebo across consecutive visits (Weeks 4 and 8) supporting further clinical development of OTO-313 for the treatment of tinnitus.",2021,OTO-313 was well-tolerated and demonstrated a higher proportion of responders than placebo across consecutive visits (Weeks 4 and 8) supporting further clinical development of OTO-313 for the treatment of tinnitus.,"['Patients with unilateral tinnitus (moderate-severe) with tinnitus duration 1 to 6\u200amonths', 'Patients With Moderate to Severe', 'Tertiary referral centers', ' Persistent Tinnitus', 'patients with tinnitus']","['OTO-313', 'placebo']","['daily ratings of tinnitus loudness and annoyance favored OTO-313', 'TFI', 'Safety and change from baseline in tinnitus functional index (TFI), daily ratings of tinnitus loudness and annoyance, and patient global impression of change (PGIC', 'adverse events', 'safety and exploratory efficacy', 'Mean TFI reduction', 'TFI score and changes in tinnitus loudness, tinnitus annoyance, and PGIC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.315331,OTO-313 was well-tolerated and demonstrated a higher proportion of responders than placebo across consecutive visits (Weeks 4 and 8) supporting further clinical development of OTO-313 for the treatment of tinnitus.,"[{'ForeName': 'Kenneth S', 'Initials': 'KS', 'LastName': 'Maxwell', 'Affiliation': 'Piedmont ENT, Winston-Salem, North Carolina.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Robinson', 'Affiliation': 'Otonomy Inc., San Diego, California.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Hoffmann', 'Affiliation': 'Otonomy Inc., San Diego, California.'}, {'ForeName': 'Huiying J', 'Initials': 'HJ', 'LastName': 'Hou', 'Affiliation': 'Otonomy Inc., San Diego, California.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Searchfield', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Baguley', 'Affiliation': 'Mental Health and Clinical Neurosciences, School of Medicine.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'McMurry', 'Affiliation': 'ENT & Allergy Associates, Louisville, Kentucky.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Piu', 'Affiliation': 'Otonomy Inc., San Diego, California.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Anderson', 'Affiliation': 'Otonomy Inc., San Diego, California.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000003369']
1886,34628152,Mental health benefits of a 1-week intensive multimodal group program for adolescents with multiple adverse childhood experiences.,"BACKGROUND


Adverse childhood experiences (ACEs) are associated with a wide range of diseases, unsafe behavior and shorter life expectancy. However, there is scarce evidence on effective interventions for children or adolescents who report multiple ACEs, including abuse, neglect and household dysfunction.
OBJECTIVE


The aim of this study was to evaluate the mental health outcomes of a multimodal program designed for adolescents with multiple ACEs.
PARTICIPANTS


Forty-four girls (aged 13-16 years, mean ACE score > 5) were randomized to an intervention group or a care-as-usual control group.
METHODS


The intervention included mindfulness-based practices, expressive arts and EMDR (Eye Movement Desensitization and Reprocessing Integrative) group treatment. We used questionnaires for adolescents to assess trauma (SPRINT, CPSS) and attention/awareness-related outcomes (MAAS-A) at baseline (T1), post-intervention (T2) and two-months post-discharge (T3).
RESULTS


Linear mixed effects model analyses showed significant Group by Time interactions on all the scales (F = 11.0, p = 0.015; F = 12.5 p < 0.001; and F = 6.4, p = 0.001, for SPRINT, CPSS and MAAS-A, respectively). After completing the program, the intervention group showed significant reduction in trauma-related outcomes (SPRINT, Δ% (T2-T1)  = -73%, p < 0.001; CPSS, Δ% (T2-T1)  = -26%, p < 0.001) while attention/awareness-related outcomes were improved by 57% (p < 0.001). These changes remained stable two months after discharge. SPRINT and CPSS scales were highly correlated (r = 0.833, p < 0.001) and outcomes from both trauma-related scales negatively correlated with mindfulness scores (MAAS-A/SPRINT, r = -0.515, p = 0.007; MAAS-A/CPSS, r = -0.553, p < 0.001).
CONCLUSIONS


Results presented here support this multimodal group intervention as a feasible and promising program for reducing the psychological burden in adolescents with a history of multiple ACEs.",2021,"SPRINT and CPSS scales were highly correlated (r = 0.833, p < 0.001) and outcomes from both trauma-related scales negatively correlated with mindfulness scores (MAAS-A/SPRINT, r = ","['Forty-four girls (aged 13-16\xa0years, mean ACE score\xa0>\xa05', 'adolescents with multiple ACEs', 'adolescents with multiple adverse childhood experiences', 'adolescents with a history of multiple ACEs']","['intensive multimodal group program', 'intervention group or a care-as-usual control group', 'mindfulness-based practices, expressive arts and EMDR (Eye Movement Desensitization and Reprocessing Integrative) group treatment']","['attention/awareness-related outcomes', 'mental health outcomes', 'trauma-related outcomes', 'SPRINT and CPSS scales']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",5.0,0.0571468,"SPRINT and CPSS scales were highly correlated (r = 0.833, p < 0.001) and outcomes from both trauma-related scales negatively correlated with mindfulness scores (MAAS-A/SPRINT, r = ","[{'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Roque-Lopez', 'Affiliation': 'Association Innocence In Danger Colombia (IIDC), 33 Avenue Saint Charles, 34090 Montpellier, France.'}, {'ForeName': 'Elkin', 'Initials': 'E', 'LastName': 'Llanez-Anaya', 'Affiliation': 'Universidad de Santander, Facultad de Ciencias Médicas y Salud, Instituto de Investigación Masira, Bucaramanga, Colombia.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Álvarez-López', 'Affiliation': 'Jacinto Benavente 3, 08100 Mollet del Valles, Spain.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Everts', 'Affiliation': 'Association Innocence In Danger Colombia (IIDC), 33 Avenue Saint Charles, 34090 Montpellier, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Serra Húnter fellow. Department of Statistics and Operations Research & IMTech. Universitat Politècnica de Catalunya · BarcelonaTech (UPC). CIBERSAM. Spain.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Davidson', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, 625 W. Washington Ave., Madison, WI 53703, United States of America.'}, {'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'Kaliman', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, 625 W. Washington Ave., Madison, WI 53703, United States of America; Universitat Oberta de Catalonia (UOC), Rambla del Poblenou, 156, 08018 Barcelona, Spain. Electronic address: pkaliman@uoc.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.105349']
1887,34628077,Evaluation of a brief psychosocial intervention for health anxiety delivered by medical assistants in primary care: Study protocol for a pilot hybrid trial.,"Health anxiety is a chronic mental health condition that exerts substantial personal and economic burdens on patients, providers, and the larger healthcare system. Patients with health anxiety experience persistent worry and dread over the possibility that they are presently ill with an undetected or poorly defined physical illness or may soon become ill despite an absence of evidence and physician reassurance of wellness. A complication of health anxiety is that the sufferer frequently denies the presence of excessive anxiety, typically attributing their distress to an inability of the medical team to correctly identify the feared illness. As a result, these patients are challenging to engage in evidence-based psychosocial interventions. The present study protocol describes a psychosocial intervention based on cognitive-behavioral therapy that is adapted for delivery by Medical Assistants in the primary care setting. The rationale for this approach is that delivery by Medical Assistants has the potential to overcome barriers to engagement that prevent effective care. Moreover, deploying a task-shifted intervention relieves strain on the care team by sharing the responsibility for helping the patient manage health anxiety. The aim of this study is to demonstrate the effectiveness of this intervention and approach on health anxiety, while simultaneously collecting data on the barriers and facilitators of implementation, consistent with a hybrid type 1 study design. We will compare patient-level outcomes for participants randomized to the study intervention versus routine referral to mental health services and characterize the potential for implementation using qualitative data drawn from patient and clinical stakeholders.",2021,"Moreover, deploying a task-shifted intervention relieves strain on the care team by sharing the responsibility for helping the patient manage health anxiety.","['health anxiety delivered by medical assistants in primary care', 'Patients with health anxiety experience persistent worry and dread']","['psychosocial intervention', 'psychosocial intervention based on cognitive-behavioral therapy']",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0334914', 'cui_str': 'Medical assistant'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0242855,"Moreover, deploying a task-shifted intervention relieves strain on the care team by sharing the responsibility for helping the patient manage health anxiety.","[{'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Brady', 'Affiliation': 'Geisel School of Medicine at Dartmouth, 1 Rope Ferry Rd, Hanover, NH 03755, USA; Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive, Lebanon, NH 03756, USA. Electronic address: robert.e.brady@hitchcock.org.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Hegel', 'Affiliation': 'Geisel School of Medicine at Dartmouth, 1 Rope Ferry Rd, Hanover, NH 03755, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Curran', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 W. Markham St, Little Rock, AR 72205, USA.'}, {'ForeName': 'Gordon J G', 'Initials': 'GJG', 'LastName': 'Asmundson', 'Affiliation': 'University of Regina, 3737 Wascana Parkway, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Geisel School of Medicine at Dartmouth, 1 Rope Ferry Rd, Hanover, NH 03755, USA; Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive, Lebanon, NH 03756, USA.'}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Bruce', 'Affiliation': 'Geisel School of Medicine at Dartmouth, 1 Rope Ferry Rd, Hanover, NH 03755, USA; Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive, Lebanon, NH 03756, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106574']
1888,34627809,Three-Year Clinical Trial of Low-Concentration Atropine for Myopia Progression Study: Continued Versus Washout: Phase 3 Report.,"PURPOSE


(1) To compare the efficacy of continued and stopping treatment for 0.05%, 0.025%, and 0.01% atropine during the third year. (2) To evaluate the efficacy of continued treatment over 3 years. (3) To investigate the rebound phenomenon and its determinants after cessation of treatment.
DESIGN


A randomized, double-masked extended trial.
PARTICIPANTS


A total of 350 of 438 children aged 4 to 12 years originally recruited into the Low-Concentration Atropine for Myopia Progression (LAMP) study.
METHODS


At the beginning of the third year, children in each group were randomized at a 1:1 ratio to continued treatment and washout subgroups. Cycloplegic spherical equivalent (SE) refraction and axial length (AL) were measured at 4-month intervals.
MAIN OUTCOME MEASURES


Changes in SE and AL between groups.
RESULTS


A total of 326 children completed 3 years of follow-up. During the third year, SE progression and AL elongation were faster in the washout subgroups than in the continued treatment groups across all concentrations: -0.68 ± 0.49 diopters (D) versus -0.28 ± 0.42 D (P < 0.001) and 0.33 ± 0.17 mm versus 0.17 ± 0.14 mm (P < 0.001) for the 0.05%; -0.57 ± 0.38 D versus -0.35 ± 0.37 D (P = 0.004) and 0.29 ± 0.14 mm versus 0.20 ± 0.15 mm (P = 0.001) for the 0.025%; -0.56 ± 0.40 D versus -0.38 ± 0.49 D (P = 0.04) and 0.29 ± 0.15 mm versus 0.24 ± 0.18 mm (P = 0.13) for the 0.01%. Over the 3-year period, SE progressions were -0.73 ± 1.04 D, -1.31 ± 0.92 D, and -1.60 ± 1.32 D (P = 0.001) for the 0.05%, 0.025%, and 0.01% groups in the continued treatment subgroups, respectively, and -1.15 ± 1.13 D, -1.47 ± 0.77 D, and -1.81 ± 1.10 D (P = 0.03), respectively, in the washout subgroup. The respective AL elongations were 0.50 ± 0.40 mm, 0.74 ± 0.41 mm, and 0.89 ± 0.53 mm (P < 0.001) for the continued treatment subgroups and 0.70 ± 0.47 mm, 0.82 ± 0.37 mm, and 0.98 ± 0.48 mm (P = 0.04) for the washout subgroup. The rebound SE progressions during washout were concentration dependent, but their differences were clinically small (P = 0.15). Older age and lower concentration were associated with smaller rebound effects in both SE progression (P < 0.001) and AL elongation (P < 0.001).
CONCLUSIONS


During the third year, continued atropine treatment achieved a better effect across all concentrations compared with the washout regimen. 0.05% atropine remained the optimal concentration over 3 years in Chinese children. The differences in rebound effects were clinically small across all 3 studied atropine concentrations. Stopping treatment at an older age and lower concentration are associated with a smaller rebound.",2021,"During the third year, SE progression and AL elongation were faster in the washout subgroups than in the continued treatment groups across all concentrations (-0.68±0.49D vs.-0.28±0.42D (P<0.001) and 0.33±0.17mm vs. 0.17±0.14mm (P<0.001) for the 0.05%; -0.57±0.38D vs. -0.35±0.37D (P=0.004) and 0.29±0.14mm vs. 0.20±0.15mm (P=0.04) for the 0.025%; -0.56±0.40D vs.-0.38±0.49D (P=0.04) and 0.29±0.15mm vs 0.24±0.18mm (P=0.13) for the 0.01%).","['Myopia Progression (LAMP', ' 350 of 438 children aged 4-12 years originally recruited into the', '326 children completed 3 years of follow-up', 'for Myopia Progression (LAMP) study METHODS']","['atropine', 'Low-concentration Atropine', 'Low-Concentration Atropine']","['rebound SE progressions', 'SE progression and AL elongation', 'Cycloplegic spherical equivalent (SE) refraction and axial length (AL', 'rebound effects']","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010586', 'cui_str': 'Cycloplegic preparation'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0549262', 'cui_str': 'Rebound effect'}]",438.0,0.142905,"During the third year, SE progression and AL elongation were faster in the washout subgroups than in the continued treatment groups across all concentrations (-0.68±0.49D vs.-0.28±0.42D (P<0.001) and 0.33±0.17mm vs. 0.17±0.14mm (P<0.001) for the 0.05%; -0.57±0.38D vs. -0.35±0.37D (P=0.004) and 0.29±0.14mm vs. 0.20±0.15mm (P=0.04) for the 0.025%; -0.56±0.40D vs.-0.38±0.49D (P=0.04) and 0.29±0.15mm vs 0.24±0.18mm (P=0.13) for the 0.01%).","[{'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Yam', 'Affiliation': ""Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Hong Kong Eye Hospital, Hong Kong; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong; Department of Ophthalmology, Hong Kong Children's Hospital. Electronic address: yamcheuksing@cuhk.edu.hk.""}, {'ForeName': 'Xiu Juan', 'Initials': 'XJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Yuzhou', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Yu Meng', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Shu Min', 'Initials': 'SM', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Department of Ophthalmology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Fen Fen', 'Initials': 'FF', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; The Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Ka Wai', 'Initials': 'KW', 'LastName': 'Kam', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Simon T', 'Initials': 'ST', 'LastName': 'Ko', 'Affiliation': ""Department of Ophthalmology, Hong Kong Children's Hospital; Department of Ophthalmology, Tung Wah Eastern Hospital, Hong Kong.""}, {'ForeName': 'Benjamin H K', 'Initials': 'BHK', 'LastName': 'Yip', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Alvin L', 'Initials': 'AL', 'LastName': 'Young', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Clement C', 'Initials': 'CC', 'LastName': 'Tham', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Hong Kong Eye Hospital, Hong Kong; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Li Jia', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Pui', 'Initials': 'CP', 'LastName': 'Pang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong.'}]",Ophthalmology,['10.1016/j.ophtha.2021.10.002']
1889,34627684,Preconception insulin resistance and neonatal birth weight in women with obesity: role of bile acids.,"RESEARCH QUESTION


Does maternal preconception insulin resistance affect neonatal birth weight among women with obesity? Is insulin resistance associated with circulating bile acids? Do bile acids influence the association between maternal preconception insulin resistance and neonatal birth weight?
DESIGN


An exploratory post-hoc analysis of the LIFEstyle randomized controlled trial comparing lifestyle intervention with conventional infertility treatment in women with a BMI of ≥29 kg/m 2 . Fasting blood samples were collected at randomization and after 3 and 6 months in 469 women. Insulin resistance was quantified using the homeostasis model assessment of insulin resistance (HOMA-IR). Bile acid sub-species were determined by liquid chromatography with tandem mass spectrometry. Singletons were included (n = 238). Birth weight Z-scores were adjusted for age, offspring gender and parity. Multilevel analysis and linear regressions were used.
RESULTS


A total of 913 pairs of simultaneous preconception HOMA-IR (median [Q25; Q75]: 2.96 [2.07; 4.16]) and total bile acid measurements (1.79 [1.10; 2.94]) µmol/l were taken. Preconception HOMA-IR was positively associated with total bile acids (adjusted B 0.15; 95% CI 0.09 to 0.22; P < 0.001) and all bile acid sub-species. At the last measurement before pregnancy, HOMA-IR (2.71 [1.91; 3.74]) was positively related to birth weight Z-score (mean ± SD 0.4 ± 1.1; adjusted B 0.08; 95% CI 0.01 to 0.14; P = 0.03). None of the preconception bile acids measured were associated with birth weight.
CONCLUSION


Maternal preconception insulin resistance is an important determinant of neonatal birth weight in women with obesity, whereas preconception bile acids are not.",2021,Preconception HOMA-IR was positively associated with total bile acids (adjusted B 0.15; 95% CI 0.09 to 0.22; P < 0.001) and all bile acid sub-species.,"['469 women', 'women with a BMI of ≥29 kg/m 2 ', 'women with obesity']",['lifestyle intervention with conventional infertility treatment'],"['Insulin resistance', 'Fasting blood samples', 'birth weight', 'total bile acids', 'Birth weight Z-scores', 'total bile acid measurements', 'Preconception insulin resistance and neonatal birth weight', 'birth weight Z-score', 'Preconception HOMA-IR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0201914', 'cui_str': 'Total bile acids measurement'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}]",913.0,0.181318,Preconception HOMA-IR was positively associated with total bile acids (adjusted B 0.15; 95% CI 0.09 to 0.22; P < 0.001) and all bile acid sub-species.,"[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Obstetrics and Gynecology, Groningen, The Netherlands.'}, {'ForeName': 'Ruxandra A', 'Initials': 'RA', 'LastName': 'Nagy', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Clinical Genetics, Groningen, The Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Groen', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Epidemiology, Groningen, The Netherlands.'}, {'ForeName': 'Astrid E P', 'Initials': 'AEP', 'LastName': 'Cantineau', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Obstetrics and Gynecology, Groningen, The Netherlands.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'van Oers', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Obstetrics and Gynecology, Groningen, The Netherlands.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'van Dammen', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Obstetrics and Gynecology, Groningen, The Netherlands; University of Groningen, University Medical Centre Groningen, Department of Epidemiology, Groningen, The Netherlands; Iowa State University, Department of Human Development and Family Studies, Ames Iowa, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Wekker', 'Affiliation': 'Academic Medical Centre, University of Amsterdam, Department of Obstetrics and Gynecology, Amsterdam, The Netherlands; Amsterdam Public Health research institute, Academic Medical Centre, University of Amsterdam, Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam, the Netherlands.'}, {'ForeName': 'Tessa J', 'Initials': 'TJ', 'LastName': 'Roseboom', 'Affiliation': 'Academic Medical Centre, University of Amsterdam, Department of Obstetrics and Gynecology, Amsterdam, The Netherlands; Amsterdam Public Health research institute, Academic Medical Centre, University of Amsterdam, Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam, the Netherlands. Electronic address: sdszgaoshanshan@163.com.'}, {'ForeName': 'Ben W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Monash University, Department of Obstetrics and Gynecology, Clayton, Australia.'}, {'ForeName': 'Uwe J F', 'Initials': 'UJF', 'LastName': 'Tietge', 'Affiliation': 'Division of Clinical Chemistry, Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden; Clinical Chemistry, Karolinska University Laboratory, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Hoek', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Obstetrics and Gynecology, Groningen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2021.08.005']
1890,34633260,"A randomized, double-blind, placebo-controlled, single, and multiple dose-escalation Phase I clinical trial to investigate the safety, pharmacokinetic, and pharmacodynamic profiles of oral S086, a novel angiotensin receptor-neprilysin inhibitor, in healthy Chinese volunteers.","BACKGROUND


This study evaluated the safety, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of single ascending doses (SAD) and multiple ascending doses (MAD) of S086 in healthy Chinese volunteers.
RESEARCH DESIGN AND METHODS


This randomized, double-blind, placebo-controlled, Phase I clinical trial enrolled 113 subjects, including 65 subjects in the SAD (60-1080 mg) study and 48 subjects in the MAD study (180-720 mg). The safety, PK (sacubitril, LBQ657, and EXP3174) and PD (MAD study: blood pressure, pulse) of S086 were assessed.
RESULTS


There were no deaths, serious adverse events, or discontinuations due to TEAEs, and there were no significant safety concerns associated with S086. PK parameters for sacubitril, LBQ657, and EXP3174 increased in a dose-dependent manner after single oral doses of S086. Plasma concentrations of sacubitril, LBQ657, and EXP3174 were maintained at steady state within 5 days of once-daily oral administration of S086. In the MAD study, S086 administration was associated with a dose-dependent decrease in mean diastolic and systolic blood pressure compared to baseline.
CONCLUSIONS


The safety and PK profile profiles of S086 support the use of S086 240 mg once daily in a future Phase II study in patients with heart failure.
TRIAL REGISTRATION


The trial is registered at chinadrugtrials.org.cn (CT.gov identifier: CTR20182350 and CTR20182351).",2021,"There were no deaths, serious adverse events, or discontinuations due to TEAEs, and there were no significant safety concerns associated with S086.","['113 subjects, including 65 subjects in the SAD (60-1080 mg) study and 48 subjects in the MAD study (180-720 mg', 'patients with heart failure', 'healthy Chinese volunteers']",['placebo'],"['safety, pharmacokinetic (PK), and pharmacodynamic (PD) profiles', 'mean diastolic and systolic blood pressure', 'safety, PK (sacubitril, LBQ657, and EXP3174) and PD (MAD study: blood pressure, pulse) of S086', 'PK parameters for sacubitril, LBQ657, and EXP3174', 'Plasma concentrations of sacubitril, LBQ657, and EXP3174', 'deaths, serious adverse events']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C5192768', 'cui_str': '1080'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C4277755', 'cui_str': 'LBQ657'}, {'cui': 'C0082525', 'cui_str': 'EXP3174'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",113.0,0.394449,"There were no deaths, serious adverse events, or discontinuations due to TEAEs, and there were no significant safety concerns associated with S086.","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Phase I Clinical Trial Unit, First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Phase I Clinical Trial Unit, First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Phase I Clinical Trial Unit, First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Mai', 'Affiliation': 'Department of Phase I Clinical Trial Unit, First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Nanguan District Maternal and Child Health and Family Planning Service Center of Changchun, Changchun, Jilin, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Shenzhen Salubris Pharmaceuticals Co., Ltd, Shenzhen, Guangdong, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shenzhen Salubris Pharmaceuticals Co., Ltd, Shenzhen, Guangdong, China.'}, {'ForeName': 'Jingchao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Shenzhen Salubris Pharmaceuticals Co., Ltd, Shenzhen, Guangdong, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Shenzhen Salubris Pharmaceuticals Co., Ltd, Shenzhen, Guangdong, China.'}, {'ForeName': 'Shiying', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Shenzhen Salubris Pharmaceuticals Co., Ltd, Shenzhen, Guangdong, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Shenzhen Salubris Pharmaceuticals Co., Ltd, Shenzhen, Guangdong, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Phase I Clinical Trial Unit, First Hospital of Jilin University, Changchun, Jilin, China.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2021.1985464']
1891,34635178,Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial.,"BACKGROUND


Opioid-related overdoses and harms have been declared a public health emergency in the United States, highlighting an urgent need to implement evidence-based treatments. Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) was funded by the National Institute on Drug Abuse to identify effective strategies for helping opioid treatment programs improve CM implementation as an adjunct to medication. Specific aims will test the impact of two different strategies on implementation outcomes (primary aim) and patient outcomes (secondary aims), as well as test putative mediators of implementation effectiveness (exploratory aim).
METHODS


A 3-cohort, cluster-randomized, type 3 hybrid design is used with the opioid treatment programs as the unit of randomization. Thirty programs are randomized to one of two conditions. The control condition is the Addiction Technology Transfer Center (ATTC) Network implementation strategy, which consists of three core approaches: didactic training, performance feedback, and on-going consultation. The experimental condition is an enhanced ATTC strategy, with the same core ATTC elements plus two additional theory-driven elements. The two additional elements are Pay-for-Performance, which aims to increase implementing staff's extrinsic motivations, and Implementation & Sustainment Facilitation, which targets staff's intrinsic motivations. Data will be collected using a novel, CM Tracker tool to document CM session delivery, session audio recordings, provider surveys, and patient surveys. Implementation outcomes include CM Exposure (number of CM sessions delivered per patient), CM Skill (ratings of CM fidelity), and CM Sustainment (number of patients receiving CM after removal of support). Patient outcomes include self-reported opioid abstinence and opioid-related problems (both assessed at 3- and 6-months post-baseline).
DISCUSSION


There is urgent public health need to improve the implementation of CM as an adjunct to medication for opioid use disorder. Consistent with its hybrid type 3 design, Project MIMIC is advancing implementation science by comparing impacts of these two multifaceted strategies on both implementation and patient outcomes, and by examining the extent to which the impacts of those strategies can be explained by putative mediators.
TRIAL REGISTRATION


This clinical trial has been registered with clinicaltrials.gov (NCT03931174). Registered April 30, 2019. https://clinicaltrials.gov/ct2/show/NCT03931174?term=project+mimic&draw=2&rank=1.",2021,"Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited.",['Clinics'],['Contingency management (CM'],"['CM Exposure (number of CM sessions delivered per patient), CM Skill (ratings of CM fidelity), and CM Sustainment', 'self-reported opioid abstinence and opioid-related problems']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",,0.10196,"Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited.","[{'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Becker', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Box G-S121-5, Providence, RI, 02912, USA. sara_becker@brown.edu.'}, {'ForeName': 'Cara M', 'Initials': 'CM', 'LastName': 'Murphy', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Box G-S121-5, Providence, RI, 02912, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Hartzler', 'Affiliation': 'Addictions, Drug, & Alcohol Institute, University of Washington, 1107 NE 45th Street, Suite 120, Seattle, WA, 98105, USA.'}, {'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Rash', 'Affiliation': 'Calhoun Cardiology Center - Behavioral Health, UConn Health, 263 Farmington Avenue, Farmington, CT, 06030, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Janssen', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Box G-S121-5, Providence, RI, 02912, USA.'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Roosa', 'Affiliation': 'Roosa Consulting, LLC, 3 Bradford Drive, Syracuse, NY, 13224, USA.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Madden', 'Affiliation': 'APT Foundation, 1 Long Wharf Drive, Suite 321, New Haven, CT, 06511, USA.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'RTI International, 3040 E. Cornwallis Rd.Research Triangle Park, P.O. Box 12194, Durham, NC, 27709, USA.'}]",Addiction science & clinical practice,['10.1186/s13722-021-00268-0']
1892,34634749,Influence of tDCS over right inferior frontal gyrus and pre-supplementary motor area on perceptual decision-making and response inhibition: A healthy ageing perspective.,"A wide body of literature suggests that transcranial direct current stimulation (tDCS) administered over the prefrontal cortex can improve executive function - including decision-making and inhibitory control - in healthy young adults. However, the effects of tDCS in older adults are largely unknown. Here, using a double-blind, sham-controlled approach, changes in a combined perceptual decision-making and inhibitory control task were assessed before and after the application of tDCS (1 mA, 20 minute) targeting the right inferior frontal gyrus (rIFG) or pre-supplementary motor area (preSMA) in 42 young (18-34 years) and 41 older (60-80 years) healthy adults. Compared to sham stimulation, anodal tDCS over the preSMA improved decision-making speed for both age groups. Furthermore, the inhibitory control performance of older and younger adults was improved by preSMA and rIFG stimulation, respectively. This study provides evidence that tDCS can improve both perceptual decision-making and inhibitory control in healthy older adults, with the causal role of the preSMA and rIFG regions in cognitive control appearing to vary as a function of healthy ageing.",2021,"Compared to sham stimulation, anodal tDCS over the preSMA improved decision-making speed for both age groups.","['42 young (18-34 years) and 41 older (60-80 years) healthy adults', 'healthy young adults', 'healthy older adults', 'older and younger adults', 'older adults']","['transcranial direct current stimulation (tDCS', 'tDCS (1 mA, 20 minute) targeting the right inferior frontal gyrus (rIFG) or pre-supplementary motor area (preSMA', 'tDCS']","['perceptual decision-making and response inhibition', 'decision-making speed']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152298', 'cui_str': 'Structure of inferior frontal gyrus'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}]","[{'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",,0.0382348,"Compared to sham stimulation, anodal tDCS over the preSMA improved decision-making speed for both age groups.","[{'ForeName': 'Hakuei', 'Initials': 'H', 'LastName': 'Fujiyama', 'Affiliation': 'Psychology, Murdoch University, Western Australia, Australia; Centre for Healthy Ageing, Health Futures Institute, Murdoch University, Western Australia, Australia; Centre for Molecular Medicine and Innovative Therapeutics, Murdoch University, Western Australia, Australia. Electronic address: H.Fujiyama@murdoch.edu.au.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Action and Cognition Laboratory, Discipline of Psychology, Murdoch University, Perth, Australia.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Puri', 'Affiliation': 'Sensorimotor Neuroscience and Ageing Research Group, School of Psychological Sciences, College of Health and Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Hinder', 'Affiliation': 'Sensorimotor Neuroscience and Ageing Research Group, School of Psychological Sciences, College of Health and Medicine, University of Tasmania, Hobart, Australia.'}]",Neurobiology of aging,['10.1016/j.neurobiolaging.2021.09.014']
1893,34634512,"Comparison of School vs Home Breakfast Consumption with Cardiometabolic and Dietary Parameters in Low-Income, Multiracial/Ethnic Elementary School-Aged Children.","BACKGROUND


Breakfast consumption is often associated with improving cardiometabolic parameters and diet quality. However, literature evaluating breakfast consumption with these outcomes between the school and home environments is limited.
OBJECTIVE


This study examined relationships between breakfast consumption locations (school vs home) and cardiometabolic parameters, breakfast dietary intake, and daily dietary intake.
DESIGN


This cross-sectional study used baseline data from TX Sprouts, a 1-year school-based gardening, nutrition, and cooking cluster-randomized trial, implemented in 16 elementary schools in Austin, TX, during 2016 to 2019.
PARTICIPANTS/SETTING


Analyses included 383 low-income, multiracial/ethnic elementary school-aged children (mean age = 9.2 years; 60.6% Hispanic; 70.5% free/reduced lunch; 58.5% home breakfast consumers).
MAIN OUTCOME MEASURES


Cardiometabolic parameters were obtained via fasting blood draws, and dietary intake was assessed using one 24-hour dietary recall conducted on a random, unannounced weekday. Cardiometabolic and dietary parameters (ie, energy intake, macronutrients, and food group servings) for breakfast and for the day were evaluated.
STATISTICAL ANALYSES PERFORMED


Multivariate analysis of covariance was performed to examine cardiometabolic parameters and dietary intake between school and home breakfasts.
RESULTS


School breakfast consumers (SBC) had lower fasting triglyceride levels than home breakfast consumers (HBC) (89.0 mg/dL vs 95.7 mg/dL; P = 0.03) (to convert to mmol/L, multiply by 0.0113). SBC had lower total fat for the day (P = 0.02) and lower total and saturated fat, sodium, and refined grains at breakfast (P ≤ 0.01) than HBC. However, SBC had lower protein at breakfast (P = 0.01) and higher carbohydrates, total sugar, and added sugar for the day and at breakfast (P ≤ 0.03) than HBC.
CONCLUSIONS


SBC compared with HBC had lower fat intake, which may have contributed to the lower triglyceride level observed in SBC, but also had lower protein intake at breakfast and higher added sugar intake for the day and at breakfast. These results suggest dietary intake differed between HBC and SBC; that is, the home and school environments, but more research is needed to evaluate if such differences are due to School Breakfast Program guidelines.",2021,"SBC had lower total fat for the day (P = 0.02) and lower total and saturated fat, sodium, and refined grains at breakfast (P ≤ 0.01) than HBC.","['TX Sprouts, a one-year school-based gardening, nutrition, and cooking cluster-randomized trial, implemented in 16 elementary schools in Austin, TX, in 2016-2019', 'Low-Income, Multi-Racial/Ethnic Elementary School-Aged Children', '383 low-income, multi-racial/ethnic elementary school-aged children (mean age 9.2 years; 60.6% Hispanic; 70.5% free/reduced lunch; 58.5% home breakfast consumers']",['School vs. Home Breakfast Consumption with Cardiometabolic and Dietary Parameters'],"['total fat', 'fasting triglyceride levels', 'triglyceride level', 'higher carbohydrates, total sugar, and added sugar', 'Cardiometabolic parameters', 'Cardiometabolic and dietary parameters']","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0605411', 'cui_str': 'austin'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",,0.0291464,"SBC had lower total fat for the day (P = 0.02) and lower total and saturated fat, sodium, and refined grains at breakfast (P ≤ 0.01) than HBC.","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Jeans', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, Texas. Electronic address: mjeans@utexas.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landry', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, Texas; Department of Pediatrics, Dell Medical Center, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Asigbee', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Vandyousefi', 'Affiliation': 'Department of Pediatrics, Bellevue Hospital, New York University Grossman Medical Center, New York, New York.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Ghaddar', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Molly S', 'Initials': 'MS', 'LastName': 'Bray', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Leidy', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, Texas; Department of Pediatrics, Dell Medical Center, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Jaimie N', 'Initials': 'JN', 'LastName': 'Davis', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, Texas.'}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2021.10.014']
1894,34634445,Impact of mind-body intervention on proinflammatory cytokines interleukin 6 and 1β: A three-arm randomized controlled trial for persons with sleep disturbance and depression.,"Depressed people are prone to sleep disturbance, which may in return perpetuate the depression. Both depression and sleep disturbance influence proinflammatory cytokines interleukin (IL) 6 and 1β. Thus interventions for depression should consider the effect on sleep disturbance, and vice versa. Integrative Body-Mind-Spirit (IBMS) and Qigong interventions have been applied in a wide range of health and mental health conditions, including depression and sleep disturbance. This study aimed to evaluate the effect of these two mind-body therapies for persons with both depressive symptoms and sleep disturbance. A three-arm randomized controlled trial was conducted among 281 participants, who were randomly assigned to either IBMS, Qigong or wait list control group. Participants in IBMS and Qigong groups received eight weekly sessions of intervention. Outcome measures were plasma concentrations of IL-6 and IL-1β, and a questionnaire containing Pittsburgh Sleep Quality Index, Center for Epidemiologic Studies Depression Scale, Somatic Symptom Inventory, Perceived Stress Scale and Body-Mind-Spirit Holistic Well-being Scale. Outcomes were assessed at baseline (T0), immediate post-intervention (T1) and at three-months post-intervention (T2). Besides intervention efficacy analysis, path analysis was performed to explore the relations among perceived stress, depression, sleep disturbance, and IL-6 and IL-1β values. The study found both IBMS and Qigong reduced depression, sleep disturbance, painful and painless somatic symptoms, IL-6 and IL-1β levels, and increased holistic well-being. The effect sizes of IBMS and Qigong, mostly in the medium magnitude range, were approximatively equivalent. Path analysis models revealed a predictive role of perceived stress in depression and sleep disturbance, a bidirectional relationship between depression and sleep disturbance, and significant influence of depression and sleep disturbance on IL-6 and IL-1β. Compared with control, the findings support the efficacy of IBMS and Qigong interventions in relieving depression and sleep disturbance, and in reducing IL-6 and IL-1β levels.",2021,"Outcome measures were plasma concentrations of IL-6 and IL-1β, and a questionnaire containing Pittsburgh Sleep Quality Index, Center for Epidemiologic Studies Depression Scale, Somatic Symptom Inventory, Perceived Stress Scale and Body-Mind-Spirit","['281 participants', 'persons with both depressive symptoms and sleep disturbance', 'persons with sleep disturbance and depression']","['IBMS, Qigong or wait list control group', 'Integrative Body-Mind-Spirit (IBMS) and Qigong interventions', 'mind-body intervention']","['plasma concentrations of IL-6 and IL-1β, and a questionnaire containing Pittsburgh Sleep Quality Index, Center for Epidemiologic Studies Depression Scale, Somatic Symptom Inventory, Perceived Stress Scale and Body-Mind-Spirit', 'relieving depression and sleep disturbance', 'perceived stress, depression, sleep disturbance, and IL-6 and IL-1β values', 'IL-6 and IL-1β levels', 'depression, sleep disturbance, painful and painless somatic symptoms, IL-6 and IL-1β levels, and increased holistic well-being']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",281.0,0.132817,"Outcome measures were plasma concentrations of IL-6 and IL-1β, and a questionnaire containing Pittsburgh Sleep Quality Index, Center for Epidemiologic Studies Depression Scale, Somatic Symptom Inventory, Perceived Stress Scale and Body-Mind-Spirit","[{'ForeName': 'Siu-Man', 'Initials': 'SM', 'LastName': 'Ng', 'Affiliation': 'Departments of Social Work and Social Administration, The University of Hong Kong, Hong Kong Special Administrative Region; Centre on Behavioral Health, Faculty of Social Sciences, The University of Hong Kong, Hong Kong Special Administrative Region. Electronic address: ngsiuman@hku.hk.'}, {'ForeName': 'Margaret X C', 'Initials': 'MXC', 'LastName': 'Yin', 'Affiliation': 'Departments of Social Work and Social Administration, The University of Hong Kong, Hong Kong Special Administrative Region; Centre on Behavioral Health, Faculty of Social Sciences, The University of Hong Kong, Hong Kong Special Administrative Region. Electronic address: yinxcan@126.com.'}, {'ForeName': 'Jessie S M', 'Initials': 'JSM', 'LastName': 'Chan', 'Affiliation': 'Departments of Social Work and Social Administration, The University of Hong Kong, Hong Kong Special Administrative Region; Centre on Behavioral Health, Faculty of Social Sciences, The University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Celia H Y', 'Initials': 'CHY', 'LastName': 'Chan', 'Affiliation': 'Departments of Social Work and Social Administration, The University of Hong Kong, Hong Kong Special Administrative Region; Centre on Behavioral Health, Faculty of Social Sciences, The University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Ted C T', 'Initials': 'TCT', 'LastName': 'Fong', 'Affiliation': 'Centre on Behavioral Health, Faculty of Social Sciences, The University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Guangdong-Hong Kong-Macau Institute of CNS Regeneration, Guangdong Key Laboratory of Brain Function and Diseases, Jinan University, Guangzhou 510632, China; Departments of Ophthalmology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region; State Key Laboratory of Brain and Cognitive Sciences, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Kwok-Fai', 'Initials': 'KF', 'LastName': 'So', 'Affiliation': 'Guangdong-Hong Kong-Macau Institute of CNS Regeneration, Guangdong Key Laboratory of Brain Function and Diseases, Jinan University, Guangzhou 510632, China; Departments of Ophthalmology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region; State Key Laboratory of Brain and Cognitive Sciences, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Lai-Ping', 'Initials': 'LP', 'LastName': 'Yuen', 'Affiliation': 'International Association for Health and Yangsheng, Hong Kong Special Administrative Region.'}, {'ForeName': 'Jian-Ping', 'Initials': 'JP', 'LastName': 'Chen', 'Affiliation': 'School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Ka-Fai', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Cecilia L W', 'Initials': 'CLW', 'LastName': 'Chan', 'Affiliation': 'Departments of Social Work and Social Administration, The University of Hong Kong, Hong Kong Special Administrative Region; Centre on Behavioral Health, Faculty of Social Sciences, The University of Hong Kong, Hong Kong Special Administrative Region.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2021.09.022']
1895,34634064,A randomized controlled trial to evaluate a behavioral economic strategy for improving mobility in veterans with chronic pain.,"Rates of chronic pain and daily opioid use are higher among veterans relative to civilian populations. Increasing physical activity can reduce pain severity and decrease opioid use among patients with chronic pain. Behavioral economic strategies can improve physical activity levels but have been undertested in veterans with chronic pain. The objective of this study was to evaluate if a financial incentive combined with a loss aversion component-a ""regret lottery"" in which veterans could win money if they met a set goal or told how much they could have won had they met their goal-would increase physical activity levels among veterans with chronic pain. A 12-week single-blinded randomized controlled trial (ClinicalTrials.gov: NCT04013529) was designed. Veterans with chronic pain (N = 40) receiving care at a specialty pain clinic were eligible for participation, and were randomly assigned (1:1) to either (a) activity trackers and daily text message reminders to increase physical activity (""control arm""), or (b) the same plus a weekly regret lottery (""intervention arm""). For those in the intervention arm, participants who met their activity goal, had a chance to win a small ($30) or large ($100) gift card incentive; those who did not meet their goals were informed of what they would have won had they met their goal. The primary outcome, physical activity, was measured using self-reported physical activity and step counts using activity trackers. Secondary outcomes included changes in physical function, chronic pain severity, depression and opioid use. The sample was primarily white, male and disabled, with an average age of 57 years. No between-arm differences were noted for physical activity, physical function, chronic pain severity, depression or opioid use. Regret lottery-based approaches may be ineffective at increasing physical activity levels in veterans with chronic pain. Trial Registry: NCT04013529.",2021,"No between-arm differences were noted for physical activity, physical function, chronic pain severity, depression or opioid use.","['Veterans with chronic pain (N = 40) receiving care at a specialty pain clinic were eligible for participation', 'veterans with chronic pain', 'The sample was primarily white, male and disabled, with an average age of 57 years', 'patients with chronic pain', 'participants who met their activity goal, had a chance to win a small ($30) or large ($100) gift card incentive; those who did not meet their goals were informed of what they would have won had they met their goal']","['financial incentive combined with a loss aversion component-a ""regret lottery', 'activity trackers and daily text message reminders to increase physical activity (""control arm""), or (b) the same plus a weekly regret lottery (""intervention arm', 'behavioral economic strategy']","['physical activity, physical function, chronic pain severity, depression or opioid use', 'physical activity, was measured using self-reported physical activity and step counts using activity trackers', 'pain severity', 'physical activity levels', 'changes in physical function, chronic pain severity, depression and opioid use']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0016999', 'cui_str': 'Gamete intrafallopian transfer'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}]","[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0233496', 'cui_str': 'Aversion'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.182722,"No between-arm differences were noted for physical activity, physical function, chronic pain severity, depression or opioid use.","[{'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Compton', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Krisda H', 'Initials': 'KH', 'LastName': 'Chaiyachati', 'Affiliation': 'The Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Tanisha', 'Initials': 'T', 'LastName': 'Dicks', 'Affiliation': 'Department of Veterans Affairs Center for Health Equity Research and Promotion (CHERP) Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Medvedeva', 'Affiliation': 'Department of Veterans Affairs Center for Health Equity Research and Promotion (CHERP) Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Manik', 'Initials': 'M', 'LastName': 'Chhabra', 'Affiliation': 'The Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0257320']
1896,34636734,Supporting the Mental Health Needs of Military Partners Through the Together Webinar Program: Pilot Randomized Controlled Trial.,"BACKGROUND


Despite an increased risk of psychological difficulties, there remains a lack of evidence-based support for the mental health needs of military partners.
OBJECTIVE


This study aims to investigate whether the Together Webinar Programme (TTP-Webinar), a 6-week structured, remote access group intervention would reduce military partners' experience of common mental health difficulties and secondary trauma symptoms.
METHODS


A pilot randomized controlled trial was used to compare the TTP-Webinar intervention with a waitlist control. The sample was UK treatment-seeking veterans engaged in a mental health charity. A total of 196 military partners (1 male and 195 females; aged mean 42.28, SD 10.82 years) were randomly allocated to the intervention (n=97) or waitlist (n=99) condition. Outcome measures were self-reported measures of common mental health difficulties, secondary trauma symptoms, and overall quality of life rating.
RESULTS


Compared with the waitlist, military partners in the TTP-Webinar had reduced common mental health difficulties (P=.02) and secondary trauma symptoms (P=.001). However, there was no difference in quality-of-life ratings (P=.06).
CONCLUSIONS


The results suggest that TTP-Webinar is an effective intervention to support the mental health difficulties of military partners. This study provides promising evidence that webinars may be an appropriate platform for providing group-based support.
TRIAL REGISTRATION


ClinicalTrials.gov NCT05013398; https://clinicaltrials.gov/ct2/show/NCT05013398.",2021,"Compared with the waitlist, military partners in the TTP-Webinar had reduced common mental health difficulties (P=.02) and secondary trauma symptoms (P=.001).","[""military partners' experience of common mental health difficulties and secondary trauma symptoms"", '196 military partners (1 male and 195 females; aged mean 42.28, SD 10.82 years']","['TTP-Webinar', 'TTP-Webinar intervention', 'Together Webinar Programme (TTP-Webinar']","['mental health difficulties', 'secondary trauma symptoms', 'quality-of-life ratings', 'self-reported measures of common mental health difficulties, secondary trauma symptoms, and overall quality of life rating']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",196.0,0.161156,"Compared with the waitlist, military partners in the TTP-Webinar had reduced common mental health difficulties (P=.02) and secondary trauma symptoms (P=.001).","[{'ForeName': 'Laura Josephine', 'Initials': 'LJ', 'LastName': 'Hendrikx', 'Affiliation': 'Combat Stress, Leatherhead, United Kingdom.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Murphy', 'Affiliation': 'Combat Stress, Leatherhead, United Kingdom.'}]",JMIR mental health,['10.2196/25622']
1897,34636711,"Ten German versions of Rey's auditory verbal learning test: Age and sex effects in 4,000 adults of the Rhineland Study.","INTRODUCTION


Detecting early pathological cognitive decline is critical for dementia and aging-related research and clinical diagnostics. Rey's Auditory Verbal Learning Test (AVLT) is commonly used to measure episodic verbal memory. The test requires participants to learn a list of 15 words over several trials. Since multiple testing is often required to detect cognitive decline, but repeating the same test can bias results, we developed 10 German AVLT word lists.
METHOD


We randomly assigned the lists to 4,000 participants (aged 30-94 years) from a population-based cohort to test their comparability, as well as aging effects and sex differences.
RESULTS


Nine lists were highly comparable, with only one being slightly more difficult. Recall performance decreased on average by 0.6-1.1 words per trial per decade of age. Perseveration errors decreased with increasing age. Women remembered on average between 0.8 and 1.5 words per trial more than men, regardless of age. Women also outperformed men in the sum of Trials 1-5, learning over trials, retroactive inhibition, and false-positive and interference errors. Proactive inhibition remained stable across age and was unaffected by sex.
CONCLUSION


This German AVLT version presents comparable lists including detailed age and sex references and therefore allows test repetition excluding training effects. These versions are a valuable resource for research and clinical application.",2021,"Women also outperformed men in the sum of Trials 1-5, learning over trials, retroactive inhibition, and false-positive and interference errors.","['4,000 adults of the Rhineland Study', '4,000 participants (aged 30-94\xa0years']","[""Rey's Auditory Verbal Learning Test (AVLT""]","['Perseveration errors', 'episodic verbal memory', 'Proactive inhibition', 'Recall performance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0233651', 'cui_str': 'Perseveration'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0033199', 'cui_str': 'Inhibition, Proactive'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",9.0,0.0718113,"Women also outperformed men in the sum of Trials 1-5, learning over trials, retroactive inhibition, and false-positive and interference errors.","[{'ForeName': 'Meta M', 'Initials': 'MM', 'LastName': 'Boenniger', 'Affiliation': 'Population Health Sciences, German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Staerk', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology (IMBIE), Faculty of Medicine, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Annabell', 'Initials': 'A', 'LastName': 'Coors', 'Affiliation': 'Population Health Sciences, German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Huijbers', 'Affiliation': 'Population Health Sciences, German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Ettinger', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Monique M B', 'Initials': 'MMB', 'LastName': 'Breteler', 'Affiliation': 'Population Health Sciences, German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2021.1984398']
1898,34648182,Nudging primary care providers to expand the opioid use disorder workforce.,"OBJECTIVE


To examine the responsiveness of primary care providers to pro-social and financial incentives to participate in a learning collaborative for the treatment of opioid use disorder (OUD).
STUDY SETTING


We conducted a statewide experiment in North Carolina from January 2019 to November 2019 to expand access to support for providers learning to treat opioid use disorder using different types of messaging and incentives.
STUDY DESIGN


We randomly assigned 15,835 primary care providers (physicians, nurse practitioners, and physician assistants) in North Carolina (NC) to receive one of four letters recruiting providers to participate in an online learning collaborative for providers learning to treat opioid use disorder. The four versions of the recruitment letters contained either pro-social messaging, mention of financial reimbursement for time spent in the learning collaborative, both, or neither.
DATA COLLECTION


We created a primary data source, tracking provider responses to the recruitment letters and emails.
PRINCIPAL FINDINGS


We found a 47.5% greater (p < 0.05) response rate using pro-social recruitment messaging that provided a greater description of the local conditions in each provider's region compared to the control group; this effect increased with higher overdose opioid death rates. Mention of financial reimbursement only modestly increased provider response rates. Some heterogeneity was observed by provider type, with NPs having the largest response to pro-social messaging.
CONCLUSIONS


Prosocial nudges had strong effects on efforts to enhance the behavioral health workforce in NC through participation in an ECHO for medication-assisted treatment (MAT) learning collaborative. The prosocial approach can and should be employed by states and professional societies in their efforts to create training programs for medication for OUD (MOUD), in order to expand access to lifesaving treatments for opioid use disorder.",2021,We found a 47.5% greater (p<0.05) response rate using pro-social recruitment messaging that provided greater description of the local conditions in each provider's region compared to the control group; this effect increased with higher overdose opioid death rates.,"['statewide experiment in North Carolina from January 2019 - November 2019 to expand access to support for providers learning to treat opioid use disorder using different types of messaging and incentives', '15,835 primary care providers (physicians, nurse practitioners, and physician assistants) in North Carolina to']",['receive one of four letters recruiting providers to participate in an on-line learning collaborative for providers learning to treat opioid use disorder'],"['overdose opioid death rates', 'provider response rates']","[{'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",15835.0,0.0864603,We found a 47.5% greater (p<0.05) response rate using pro-social recruitment messaging that provided greater description of the local conditions in each provider's region compared to the control group; this effect increased with higher overdose opioid death rates.,"[{'ForeName': 'Marisa Elena', 'Initials': 'ME', 'LastName': 'Domino', 'Affiliation': 'UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Sylvia', 'Affiliation': 'UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Green', 'Affiliation': 'UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Health services research,['10.1111/1475-6773.13894']
1899,34627141,"Joint modelling of multivariate longitudinal clinical laboratory safety outcomes, concomitant medication and clinical adverse events: application to artemisinin-based treatment during pregnancy clinical trial.","BACKGROUND


In drug trials, clinical adverse events (AEs), concomitant medication and laboratory safety outcomes are repeatedly collected to support drug safety evidence. Despite the potential correlation of these outcomes, they are typically analysed separately, potentially leading to misinformation and inefficient estimates due to partial assessment of safety data. Using joint modelling, we investigated whether clinical AEs vary by treatment and how laboratory outcomes (alanine amino-transferase, total bilirubin) and concomitant medication are associated with clinical AEs over time following artemisinin-based antimalarial therapy.
METHODS


We used data from a trial of artemisinin-based treatments for malaria during pregnancy that randomized 870 women to receive artemether-lumefantrine (AL), amodiaquine-artesunate (ASAQ) and dihydroartemisinin-piperaquine (DHAPQ). We fitted a joint model containing four sub-models from four outcomes: longitudinal sub-model for alanine aminotransferase, longitudinal sub-model for total bilirubin, Poisson sub-model for concomitant medication and Poisson sub-model for clinical AEs. Since the clinical AEs was our primary outcome, the longitudinal sub-models and concomitant medication sub-model were linked to the clinical AEs sub-model via current value and random effects association structures respectively. We fitted a conventional Poisson model for clinical AEs to assess if the effect of treatment on clinical AEs (i.e. incidence rate ratio (IRR)) estimates differed between the conventional Poisson and the joint models, where AL was reference treatment.
RESULTS


Out of the 870 women, 564 (65%) experienced at least one AE. Using joint model, AEs were associated with the concomitant medication (log IRR 1.7487; 95% CI: 1.5471, 1.9503; p < 0.001) but not the total bilirubin (log IRR: -0.0288; 95% CI: - 0.5045, 0.4469; p = 0.906) and alanine aminotransferase (log IRR: 0.1153; 95% CI: - 0.0889, 0.3194; p = 0.269). The Poisson model underestimated the effects of treatment on AE incidence such that log IRR for ASAQ was 0.2118 (95% CI: 0.0082, 0.4154; p = 0.041) for joint model compared to 0.1838 (95% CI: 0.0574, 0.3102; p = 0.004) for Poisson model.
CONCLUSION


We demonstrated that although the AEs did not vary across the treatments, the joint model yielded efficient AE incidence estimates compared to the Poisson model. The joint model showed a positive relationship between the AEs and concomitant medication but not with laboratory outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT00852423.",2021,"Using joint model, AEs were associated with the concomitant medication (log IRR 1.7487; 95% CI: 1.5471, 1.9503; p < 0.001) but not the total bilirubin (log IRR: -0.0288; 95% CI: - 0.5045, 0.4469; p = 0.906) and alanine aminotransferase (log IRR: 0.1153; 95% CI: - 0.0889, 0.3194; p = 0.269).","['malaria during pregnancy that randomized 870 women to receive', '870 women, 564 (65%) experienced at least one AE']","['artemisinin-based antimalarial therapy', 'joint model containing four sub-models from four outcomes: longitudinal sub-model for alanine aminotransferase, longitudinal sub-model for total bilirubin, Poisson sub-model for concomitant medication and Poisson sub-model for clinical AEs', 'artemether-lumefantrine (AL), amodiaquine-artesunate (ASAQ) and dihydroartemisinin-piperaquine (DHAPQ']","['total bilirubin', 'clinical AEs (i.e. incidence rate ratio (IRR)) estimates', 'alanine aminotransferase']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C1869889', 'cui_str': 'artesunate and amodiaquine'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",870.0,0.494728,"Using joint model, AEs were associated with the concomitant medication (log IRR 1.7487; 95% CI: 1.5471, 1.9503; p < 0.001) but not the total bilirubin (log IRR: -0.0288; 95% CI: - 0.5045, 0.4469; p = 0.906) and alanine aminotransferase (log IRR: 0.1153; 95% CI: - 0.0889, 0.3194; p = 0.269).","[{'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Patson', 'Affiliation': 'School of Public Health, University of the Witwatersrand, Johannesburg, South Africa. noelpatson@gmail.com.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': ""D'Alessandro"", 'Affiliation': 'Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Gambia.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Chapotera', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Mwapasa', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Mathanga', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Kazembe', 'Affiliation': 'Department of Biostatistics, University of Namibia, Windhoek, Namibia.'}, {'ForeName': 'Miriam K', 'Initials': 'MK', 'LastName': 'Laufer', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Chirwa', 'Affiliation': 'School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.'}]",BMC medical research methodology,['10.1186/s12874-021-01412-9']
1900,34635680,Effects of Bushen-Tiaojing-Fang on the pregnancy outcomes of infertile patients with repeated controlled ovarian stimulation.,"Bushen-Tiaojing-Fang (BSTJF) is commonly used to treat infertility. This study investigated the effects of BSTJF on the pregnancy outcomes of patients with repeated controlled ovarian stimulation (COS), on mitochondrial function, and on oxidative stress in ovarian granulosa cells (GCs) and follicular fluid (FF). The samples and clinical data of 97 patients, including 35 in the control group, 29 in the placebo group and 33 in the BSTJF group, were collected for this study. The mitochondrial ultrastructure, ATP content, mitochondrial DNA (mtDNA) number, 8-hydroxy-2-deoxyguanosine (8-OHdG), Mn-superoxide dismutase (Mn-SOD), glutathione peroxidase (GSH-Px) activity levels, and mRNA expression levels of Mn-SOD, GSH-Px, and nuclear factor erythroid-derived factor 2-related factor 2 (Nrf2) were analyzed. The high-grade embryo (P < 0.001), implantation (P = 0.033), and clinical pregnancy (P = 0.031) rates, as well as the ATP content (P = 0.014), mtDNA number (P = 0.035), GSH-Px activity (P = 0.004 in GCs and P = 0.008 in FF) and mRNA expression levels (P = 0.019), were significantly lower in the placebo group than in the control group, whereas the 8-OHdG content was significantly (P = 0.006 in FF) higher in the placebo group than in the control group. Compared with those in the placebo group, the high-grade embryo rate (P = 0.007), antioxidant enzyme activity (P = 0.037 and 0.036 in Mn-SOD; P = 0.047 and 0.030 in GSH-Px) and mRNA level (P < 0.001 in Nrf2, P = 0.039 in Mn-SOD and P = 0.002 in GSH-Px) were significantly higher in the BSTJF group, as were changes in mitochondrial ultrastructure, ATP (P = 0.040) and mtDNA number (P = 0.013). In conclusion, BSTJF can improve oxidative stress in patients with repeated COS and pregnancy outcomes.",2021,"The high-grade embryo (P < 0.001), implantation (P = 0.033), and clinical pregnancy (P = 0.031) rates, as well as the ATP content (P = 0.014), mtDNA number (P = 0.035), GSH-Px activity (P = 0.004 in GCs and P = 0.008 in FF) and mRNA expression levels (P = 0.019), were significantly lower in the placebo group than in the control group, whereas the 8-OHdG content was significantly (P = 0.006 in FF) higher in the placebo group than in the control group.","['patients with repeated controlled ovarian stimulation (COS', 'patients with repeated COS and pregnancy outcomes', 'infertile patients with repeated controlled ovarian stimulation', '97 patients, including 35 in the control group, 29 in the placebo group and 33 in the BSTJF group']","['placebo', 'Bushen-Tiaojing-Fang', 'Bushen-Tiaojing-Fang (BSTJF', 'BSTJF']","['oxidative stress in ovarian granulosa cells (GCs) and follicular fluid (FF', 'high-grade embryo rate', 'mitochondrial ultrastructure, ATP content, mitochondrial DNA (mtDNA) number, 8-hydroxy-2-deoxyguanosine (8-OHdG), Mn-superoxide dismutase (Mn-SOD), glutathione peroxidase (GSH-Px) activity levels, and mRNA expression levels of Mn-SOD, GSH-Px, and nuclear factor erythroid-derived factor 2-related factor 2 (Nrf2', 'mitochondrial ultrastructure, ATP', 'oxidative stress', '8-OHdG content', 'clinical pregnancy', 'antioxidant enzyme activity', 'ATP content', 'mRNA expression levels', 'mRNA level', 'GSH-Px activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0574439', 'cui_str': 'Fang language'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574439', 'cui_str': 'Fang language'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0041623', 'cui_str': 'ultrastructure'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0024708', 'cui_str': 'Manganese Superoxide Dismutase'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}]",97.0,0.255678,"The high-grade embryo (P < 0.001), implantation (P = 0.033), and clinical pregnancy (P = 0.031) rates, as well as the ATP content (P = 0.014), mtDNA number (P = 0.035), GSH-Px activity (P = 0.004 in GCs and P = 0.008 in FF) and mRNA expression levels (P = 0.019), were significantly lower in the placebo group than in the control group, whereas the 8-OHdG content was significantly (P = 0.006 in FF) higher in the placebo group than in the control group.","[{'ForeName': 'Yu-Cong', 'Initials': 'YC', 'LastName': 'Ma', 'Affiliation': 'Hebei Key Laboratory of Integrative Medicine on Liver-Kidney Patterns, Institute of Integrative Medicine, College of Integrative Medicine, Hebei University of Chinese Medicine, Shijiazhuang, 050091, China.'}, {'ForeName': 'Gui-Min', 'Initials': 'GM', 'LastName': 'Hao', 'Affiliation': 'Department of Reproductive Medicine, The Second Hospital of Hebei Medical University, Shijiazhuang, 050000, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Zhao', 'Affiliation': 'Department of Reproductive Medicine, The Second Hospital of Hebei Medical University, Shijiazhuang, 050000, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Department of Reproductive Medicine, The Second Hospital of Hebei Medical University, Shijiazhuang, 050000, China.'}, {'ForeName': 'Yan-Li', 'Initials': 'YL', 'LastName': 'Fan', 'Affiliation': 'Department of Reproductive Medicine, The Second Hospital of Hebei Medical University, Shijiazhuang, 050000, China.'}, {'ForeName': 'Shuan-Cheng', 'Initials': 'SC', 'LastName': 'Zhang', 'Affiliation': 'Hebei Key Laboratory of Integrative Medicine on Liver-Kidney Patterns, Institute of Integrative Medicine, College of Integrative Medicine, Hebei University of Chinese Medicine, Shijiazhuang, 050091, China.'}, {'ForeName': 'Jing-Wei', 'Initials': 'JW', 'LastName': 'Chen', 'Affiliation': 'Hebei Key Laboratory of Integrative Medicine on Liver-Kidney Patterns, Institute of Integrative Medicine, College of Integrative Medicine, Hebei University of Chinese Medicine, Shijiazhuang, 050091, China.'}, {'ForeName': 'Yu-Cong', 'Initials': 'YC', 'LastName': 'Cao', 'Affiliation': 'Hebei Key Laboratory of Integrative Medicine on Liver-Kidney Patterns, Institute of Integrative Medicine, College of Integrative Medicine, Hebei University of Chinese Medicine, Shijiazhuang, 050091, China.'}, {'ForeName': 'Feng-Li', 'Initials': 'FL', 'LastName': 'Guan', 'Affiliation': 'Hebei Key Laboratory of Integrative Medicine on Liver-Kidney Patterns, Institute of Integrative Medicine, College of Integrative Medicine, Hebei University of Chinese Medicine, Shijiazhuang, 050091, China.'}, {'ForeName': 'Jing-Ran', 'Initials': 'JR', 'LastName': 'Geng', 'Affiliation': 'Hebei Key Laboratory of Integrative Medicine on Liver-Kidney Patterns, Institute of Integrative Medicine, College of Integrative Medicine, Hebei University of Chinese Medicine, Shijiazhuang, 050091, China.'}, {'ForeName': 'Bu-Lang', 'Initials': 'BL', 'LastName': 'Gao', 'Affiliation': 'Department of Reproductive Medicine, The Second Hospital of Hebei Medical University, Shijiazhuang, 050000, China.'}, {'ForeName': 'Hui-Lan', 'Initials': 'HL', 'LastName': 'Du', 'Affiliation': 'Hebei Key Laboratory of Integrative Medicine on Liver-Kidney Patterns, Institute of Integrative Medicine, College of Integrative Medicine, Hebei University of Chinese Medicine, Shijiazhuang, 050091, China. duhuilan@hebcm.edu.cn.'}]",Scientific reports,['10.1038/s41598-021-94366-3']
1901,34635529,Infectious diseases experts as part of the antibiotic stewardship team in primary care: protocol for a cluster-randomised blinded study (IDASP).,"INTRODUCTION


Antibiotic overuse is directly related to antibiotic resistance, and primary care is one of the main reasons for this overuse. This study aims to demonstrate that including experts on infectious diseases (ID) within the antimicrobial stewardship (AMS) programme team in primary care settings achieves higher reductions in overall antibiotic consumption and increases the quality of prescription.
METHODS AND ANALYSIS


A multicentre, cluster-randomised, blinded clinical trial will be conducted between 2021 and 2023. Six primary care centres will be randomly assigned to an advanced or a standard AMS programme. The advanced AMS programme will consist of a standard AMS programme combined with the possibility that general practitioners (GP) will discuss patients' therapies with ID experts telephonically during working days and biweekly meetings. The main endpoint will be overall antibiotic consumption, defined as daily defined dose per 1000 inhabitants per day (DHD). Secondary end-points will be: (1) unnecessary antibiotic prescriptions in patients diagnosed with upper respiratory tract or urinary tract infection, (2) adequacy of antibiotic prescription, (3) reattendance to GP or emergency room within 30 days after the initial GP visit and (4) hospital admissions for any reason within 30 days after the GP visit. Two secondary endpoints (unnecessary antibiotic therapy and adequacy of therapy) will be evaluated by blinded investigators.We will select three clusters (centres) per arm (coverage of 147 644 inhabitants) which will allow the rejection of the null hypothesis of equal consumption with a power of 80%, assuming a moderate intracluster correlation of 0.2, an intracluster variance of 4 and a mean difference of 1 DHD. The type I error will be set at 5%.
ETHICS AND DISSEMINATION


The protocol was reviewed and approved by local ethics committees. The results of this study will be published in peer-reviewed journals and presented at medical conferences.
TRIAL REGISTRATION NUMBER


NCT04848883.",2021,"We will select three clusters (centres) per arm (coverage of 147 644 inhabitants) which will allow the rejection of the null hypothesis of equal consumption with a power of 80%, assuming a moderate intracluster correlation of 0.2, an intracluster variance of 4 and a mean difference of 1 DHD.","['patients diagnosed with upper respiratory tract or urinary tract infection, (2) adequacy of antibiotic prescription, (3) reattendance to GP or emergency room within 30 days after the initial GP visit and (4) hospital admissions for any reason within 30 days after the GP visit', '2021 and 2023', 'Six primary care centres']","['advanced or a standard AMS programme', 'antimicrobial stewardship (AMS) programme team']","['overall antibiotic consumption, defined as daily defined dose per 1000 inhabitants per day (DHD', 'endpoints (unnecessary antibiotic therapy and adequacy of therapy', 'overall antibiotic consumption', 'unnecessary antibiotic prescriptions', 'quality of prescription']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0458578', 'cui_str': 'Upper respiratory tract structure'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.2735,"We will select three clusters (centres) per arm (coverage of 147 644 inhabitants) which will allow the rejection of the null hypothesis of equal consumption with a power of 80%, assuming a moderate intracluster correlation of 0.2, an intracluster variance of 4 and a mean difference of 1 DHD.","[{'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Ronda', 'Affiliation': ""Department of Infectious Diseases, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Padullés', 'Affiliation': ""Department of Pharmacy, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Simonet', 'Affiliation': ""Primary Healthcare Centre Viladecans-2, Servei d'Atenció Primària Delta de Llobregat, Viladecans, Barcelona, Spain.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Rodríguez', 'Affiliation': ""Pharmacy Division, Servei d'Atenció Primària Delta de Llobregat, Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Cinta', 'Initials': 'C', 'LastName': 'Estrada', 'Affiliation': ""Primary Healthcare Centre Sant Josep, Servei d'Atenció Primària Delta de Llobregat, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lérida', 'Affiliation': 'Department of Internal Medicine, Hospital de Viladecans, Viladecans, Barcelona, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Ferro', 'Affiliation': ""Clinical Pharmacologist, Servei d'Atenció Primària Delta de Llobregat. Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cobo', 'Affiliation': ""Department of Pharmacy, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Fe', 'Initials': 'F', 'LastName': 'Tubau', 'Affiliation': ""Department of Microbiology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Lluïsa', 'Initials': 'L', 'LastName': 'Gardeñes', 'Affiliation': ""Primary Healthcare Centre El Castell, Servei d'Atenció Primària Delta de Llobregat, Castelldefels, Barcelona, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Freixedas', 'Affiliation': ""Primary Healthcare Centre Disset de Setembre, Servei d'Atenció Primària Delta de Llobregat, El Prat de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'López', 'Affiliation': ""Primary Healthcare Centre Santa Eulàlia Nord, Servei d'Atenció Primària Delta de Llobregat, Hospitalet del Llobregat, Barcelona, Spain.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Carrera', 'Affiliation': ""Primary Healthcare Centre Gava-1, Servei d'Atenció Primària Delta de Llobregat, Gavà, Barcelona, Spain.""}, {'ForeName': 'Natàlia', 'Initials': 'N', 'LastName': 'Pallarés', 'Affiliation': ""Biostatistics Unit, Institut Investigacions Biomèdiques de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Tebe', 'Affiliation': ""Biostatistics Unit, Institut Investigacions Biomèdiques de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Carratala', 'Affiliation': ""Department of Infectious Diseases, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Puig-Asensio', 'Affiliation': ""Department of Infectious Diseases, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Shaw', 'Affiliation': ""Department of Infectious Diseases, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain eshawp@gmail.com.""}]",BMJ open,['10.1136/bmjopen-2021-053160']
1902,34634254,"Vaccine efficacy against persistent human papillomavirus (HPV) 16/18 infection at 10 years after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre, prospective, cohort study.","BACKGROUND


A randomised trial designed to compare three and two doses of quadrivalent human papillomavirus (HPV) vaccine in adolescent girls in India was converted to a cohort study after suspension of HPV vaccination in trials by the Indian Government. In this Article, the revised aim of the cohort study was to compare vaccine efficacy of single dose to that of three and two doses in protecting against persistent HPV 16 and 18 infection at 10 years post vaccination.
METHODS


In the randomised trial, unmarried girls aged 10-18 years were recruited from nine centres across India and randomly assigned to either two doses or three doses of the quadrivalent HPV vaccine (Gardasil [Merck Sharp & Dohme, Whitehouse Station, NJ, USA]; 0·5 mL administered intramuscularly). After suspension of recruitment and vaccination, the study became a longitudinal, prospective cohort study by default, and participants were allocated to four cohorts on the basis of the number vaccine doses received per protocol: the two-dose cohort (received vaccine on days 1 and 180 or later), three-dose cohort (days 1, 60, and 180 or later), two-dose default cohort (days 1 and 60 or later), and the single-dose default cohort. Participants were followed up yearly. Cervical specimens were collected from participants 18 months after marriage or 6 months after first childbirth, whichever was earlier, to assess incident and persistent HPV infections. Married participants were screened for cervical cancer as they reached 25 years of age. Unvaccinated women age-matched to the married vaccinated participants were recruited to serve as controls. Vaccine efficacy against persistent HPV 16 and 18 infections (the primary endpoint) was analysed for single-dose recipients and compared with that in two-dose and three-dose recipients after adjusting for imbalance in the distribution of potential confounders between the unvaccinated and vaccinated cohorts. This trial is registered with ISRCTN, ISRCTN98283094, and ClinicalTrials.gov, NCT00923702.
FINDINGS


Vaccinated participants were recruited between Sept 1, 2009, and April 8, 2010 (date of vaccination suspension), and followed up over a median duration of 9·0 years (IQR 8·2-9·6). 4348 participants had three doses, 4980 had two doses (0 and 6 months), and 4949 had a single dose. Vaccine efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95·4% (95% CI 85·0-99·9) in the single-dose default cohort (2135 women assessed), 93·1% (77·3-99·8) in the two-dose cohort (1452 women assessed), and 93·3% (77·5-99·7) in three-dose recipients (1460 women assessed).
INTERPRETATION


A single dose of HPV vaccine provides similar protection against persistent infection from HPV 16 and 18, the genotypes responsible for nearly 70% of cervical cancers, to that provided by two or three doses.
FUNDING


Bill & Melinda Gates Foundation.",2021,Vaccine efficacy against persistent HPV 16 and 18 infections (the primary endpoint) was analysed for single-dose recipients and compared with that in two-dose and three-dose recipients after adjusting for imbalance in the distribution of potential confounders between the unvaccinated and vaccinated cohorts.,"['Married participants were screened for cervical cancer as they reached 25 years of age', '4348 participants had three doses, 4980 had two doses (0 and 6 months), and 4949 had a single dose', 'persistent human papillomavirus (HPV', 'adolescent girls in India was converted to a cohort study after suspension of HPV vaccination in trials by the Indian Government', 'Vaccinated participants were recruited between Sept 1, 2009, and April 8, 2010 (date of vaccination suspension), and followed up over a median duration of 9·0 years (IQR 8·2-9·6', 'participants evaluable for the endpoint was 95·4% (95% CI 85·0-99·9) in the single-dose default cohort (2135 women assessed), 93·1% (77·3-99·8) in the two-dose cohort (1452 women assessed), and 93·3% (77·5-99·7) in three-dose recipients (1460 women assessed', 'Unvaccinated women age-matched to the married vaccinated participants', '10-18 years were recruited from nine centres across India', 'unmarried girls aged']","['quadrivalent HPV vaccine', 'quadrivalent HPV vaccine (Gardasil [Merck Sharp & Dohme, Whitehouse Station, NJ, USA', 'HPV vaccine', 'quadrivalent human papillomavirus (HPV) vaccine', 'vaccine']","['Vaccine efficacy', 'vaccine efficacy']","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4301990', 'cui_str': 'Date of vaccination'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C1721787', 'cui_str': 'Gardasil'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",18.0,0.443002,Vaccine efficacy against persistent HPV 16 and 18 infections (the primary endpoint) was analysed for single-dose recipients and compared with that in two-dose and three-dose recipients after adjusting for imbalance in the distribution of potential confounders between the unvaccinated and vaccinated cohorts.,"[{'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Basu', 'Affiliation': 'Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France. Electronic address: basup@iarc.fr.'}, {'ForeName': 'Sylla G', 'Initials': 'SG', 'LastName': 'Malvi', 'Affiliation': 'Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital, Barshi District Solapur, Maharashtra, India.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Jehangir Clinical Development Centre, Jehangir Hospital Premises, Pune, India.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhatla', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Muwonge', 'Affiliation': 'Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lucas', 'Affiliation': 'Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Yogesh', 'Initials': 'Y', 'LastName': 'Verma', 'Affiliation': 'Sikkim Manipal Institute of Medical Sciences, Sikkim Manipal University, Gangtok, Sikkim, India.'}, {'ForeName': 'Pulikkottil O', 'Initials': 'PO', 'LastName': 'Esmy', 'Affiliation': 'Christian Fellowship Community Health Centre, Ambillikai, Dindigul District, Tamil Nadu, India.'}, {'ForeName': 'Usha Rani Reddy', 'Initials': 'URR', 'LastName': 'Poli', 'Affiliation': 'Public Health Foundation of India, IIPH-Hyderabad, Hyderabad, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Department of Community Oncology, Gujarat Cancer and Research Institute, M P Shah Cancer Hospital, Civil Hospital Campus, Asarwa, Ahmedabad, India.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zomawia', 'Affiliation': 'Civil Hospital, Aizawl, Mizoram, India.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Pimple', 'Affiliation': 'Department of Preventive Oncology, Centre for Cancer Epidemiology, Tata Memorial Centre, Homi Bhabha National Institute, Parel, Mumbai, India.'}, {'ForeName': 'Kasturi', 'Initials': 'K', 'LastName': 'Jayant', 'Affiliation': 'Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital, Barshi District Solapur, Maharashtra, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Hingmire', 'Affiliation': 'Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital, Barshi District Solapur, Maharashtra, India.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Chiwate', 'Affiliation': 'Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital, Barshi District Solapur, Maharashtra, India.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Divate', 'Affiliation': 'Jehangir Clinical Development Centre, Jehangir Hospital Premises, Pune, India.'}, {'ForeName': 'Shachi', 'Initials': 'S', 'LastName': 'Vashist', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Gauravi', 'Initials': 'G', 'LastName': 'Mishra', 'Affiliation': 'Department of Preventive Oncology, Centre for Cancer Epidemiology, Tata Memorial Centre, Homi Bhabha National Institute, Parel, Mumbai, India.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Jadhav', 'Affiliation': 'Jehangir Clinical Development Centre, Jehangir Hospital Premises, Pune, India.'}, {'ForeName': 'Maqsood', 'Initials': 'M', 'LastName': 'Siddiqi', 'Affiliation': 'Cancer Foundation of India, Kolkata, West Bengal, India.'}, {'ForeName': 'Subha', 'Initials': 'S', 'LastName': 'Sankaran', 'Affiliation': 'Rajiv Gandhi Centre for Biotechnology, Poojappura, Thiruvananthapuram, Kerala, India.'}, {'ForeName': 'Priya Ramesh', 'Initials': 'PR', 'LastName': 'Prabhu', 'Affiliation': 'Human Biology Division, Fred Hutchinson Cancer Research Centre, Seattle, WA, USA.'}, {'ForeName': 'Thiraviam Pillai Rameshwari Ammal', 'Initials': 'TPRA', 'LastName': 'Kannan', 'Affiliation': 'Rajiv Gandhi Centre for Biotechnology, Poojappura, Thiruvananthapuram, Kerala, India.'}, {'ForeName': 'Rintu', 'Initials': 'R', 'LastName': 'Varghese', 'Affiliation': 'Rajiv Gandhi Centre for Biotechnology, Poojappura, Thiruvananthapuram, Kerala, India.'}, {'ForeName': 'Surendra S', 'Initials': 'SS', 'LastName': 'Shastri', 'Affiliation': 'Department of Health Disparities Research, Division of Cancer Prevention and Population Sciences, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Devasena', 'Initials': 'D', 'LastName': 'Anantharaman', 'Affiliation': 'Rajiv Gandhi Centre for Biotechnology, Poojappura, Thiruvananthapuram, Kerala, India.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Gheit', 'Affiliation': 'Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Tommasino', 'Affiliation': 'Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sauvaget', 'Affiliation': 'Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'M Radhakrishna', 'Initials': 'MR', 'LastName': 'Pillai', 'Affiliation': 'Rajiv Gandhi Centre for Biotechnology, Poojappura, Thiruvananthapuram, Kerala, India.'}, {'ForeName': 'Rengaswamy', 'Initials': 'R', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Research Triangle Institute International India, New Delhi, India.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00453-8']
1903,34634239,Single session transcranial direct current stimulation to the primary motor cortex fails to enhance early motor sequence learning in Parkinson's disease.,"INTRODUCTION


Explicit motor sequence learning is impaired in Parkinson's disease (PD). Transcranial direct current stimulation (tDCS) applied over the motor cortex in healthy can improve explicit motor learning, but comparative effects in PD are unknown. This exploratory study aims to examine the effect of single session tDCS on explicit motor sequence learning in PD.
METHODS


Thirty-three people with mild to moderate PD learnt a short and long finger tapping sequence with their right hand. Participants received either anodal, cathodal, or sham tDCS applied over the left primary motor cortex during task practice. Single- and dual-task finger tapping performance was assessed before and after task practice and functional near-infrared spectroscopy used to measure task related changes of oxygenated haemoglobin.
RESULTS


Finger tapping performance of short and long sequences under single-task conditions significantly improved following practice (p = 0.010 and p < 0.001, respectively). A condition-by-time interaction trend was observed for the long finger tapping sequence (p = 0.069) driven by improved performance in the cathodal (p = 0.001) and sham (p < 0.001) tDCS conditions, but not anodal tDCS (p = 0.198). The primary and premotor cortex and supplementary motor area were active in all tasks. No interaction or main effects were observed for task related changes of oxygenated haemoglobin.
CONCLUSIONS


PD patients retain the capacity to learn an explicit sequence of movements. Motor cortex tDCS does not improve explicit motor learning in PD and anodal tDCS may even suppress the rate of learning.",2021,"RESULTS


Finger tapping performance of short and long sequences under single-task conditions significantly improved following practice (p = 0.010 and p < 0.001, respectively).","[""Parkinson's disease"", 'PD', ""Parkinson's disease (PD"", 'Thirty-three people with mild to moderate PD learnt a short and long finger tapping sequence with their right hand']","['single session tDCS', 'Transcranial direct current stimulation (tDCS', 'anodal, cathodal, or sham tDCS']","['long finger tapping sequence', 'Finger tapping performance of short and long sequences under single-task conditions']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",33.0,0.220602,"RESULTS


Finger tapping performance of short and long sequences under single-task conditions significantly improved following practice (p = 0.010 and p < 0.001, respectively).","[{'ForeName': 'Michael William', 'Initials': 'MW', 'LastName': 'Simpson', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Mak', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. Electronic address: Margaret.Mak@polyu.edu.hk.'}]",Behavioural brain research,['10.1016/j.bbr.2021.113624']
1904,34636026,Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1.,"INTRODUCTION


The aim of this work is to assess the effect of upadacitinib versus adalimumab and placebo on patient-reported outcomes (PROs) in psoriatic arthritis (PsA) patients with inadequate responses to ≥ 1 non-biologic disease-modifying anti-rheumatic drugs (non-bDMARD-IR) in SELECT PsA-1.
METHODS


In this placebo- and active comparator, phase 3 randomized, controlled trial, patients received daily upadacitinib 15 or 30 mg, placebo, or adalimumab 40 mg every other week through 56 weeks. At week 24, placebo-assigned patients were rerandomized to upadacitinib 15 or 30 mg. PROs included Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Short Form 36 Health Survey (SF-36), EQ-5D-5L index score, Bath Ankylosing Spondylitis Disease Activity Index, morning stiffness, Self-Assessment of Psoriasis Symptoms, and Work Productivity and Activity Impairment. Mean changes from baseline in PROs, improvements ≥ minimum clinically important differences (MCID), scores ≥ normative values, and sustained clinically meaningful responses were compared between treatment groups.
RESULTS


At weeks 12 and 24, upadacitinib treatment resulted in improvements from baseline versus placebo across all PROs as well as improvements versus adalimumab in HAQ-DI and SF-36 Physical Component Summary score (nominal p < 0.05). Improvements in PtGA, pain, and HAQ-DI were reported as early as week 2. At week 12, significantly (nominal p < 0.05) more upadacitinib- versus placebo-treated patients reported improvements ≥ MCID across all PROs including seven SF-36 domains. The proportions of upadacitinib-treated patients reporting clinically meaningful improvements at week 12 were similar to or greater than with adalimumab and sustained through week 56. Significantly (nominal p < 0.05) more upadacitinib-treated (both doses) patients reported scores ≥ normative values at week 12 versus placebo, and scores were generally similar to or greater than adalimumab.
CONCLUSIONS


Upadacitinib treatment provides rapid, sustained, and clinically meaningful improvements in PROs in non-bDMARD-IR patients with PsA. SELECT-PsA 1 ClinicalTrials.gov number, NCT03104400.",2021,"Significantly (nominal p < 0.05) more upadacitinib-treated (both doses) patients reported scores ≥ normative values at week 12 versus placebo, and scores were generally similar to or greater than adalimumab.
","['Patients with Psoriatic Arthritis', 'psoriatic arthritis (PsA) patients with inadequate responses to\u2009≥\u20091 non-biologic disease-modifying anti-rheumatic drugs (non-bDMARD-IR']","['upadacitinib versus adalimumab and placebo', 'daily upadacitinib 15 or 30\xa0mg, placebo, or adalimumab', 'Placebo or Adalimumab', 'placebo']","['Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue', 'PROs, improvements\u2009≥\u2009minimum clinically important differences (MCID), scores\u2009≥\u2009normative values, and sustained clinically meaningful responses', 'PtGA, pain, and HAQ-DI', 'HAQ-DI and SF-36 Physical Component Summary score', 'EQ-5D-5L index score, Bath Ankylosing Spondylitis Disease Activity Index, morning stiffness, Self-Assessment of Psoriasis Symptoms, and Work Productivity and Activity Impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}]","[{'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.455821,"Significantly (nominal p < 0.05) more upadacitinib-treated (both doses) patients reported scores ≥ normative values at week 12 versus placebo, and scores were generally similar to or greater than adalimumab.
","[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Department of Rheumatology, Swedish Medical Center, Providence St Joseph Health and University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Enrique R', 'Initials': 'ER', 'LastName': 'Soriano', 'Affiliation': 'Department of Public Health, Rheumatology Unit, Internal Medicine Services, Hospital Italiano de Buenos Aires, Instituto Universitario Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Mitsumasa', 'Initials': 'M', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Salvarani', 'Affiliation': 'Rheumatology Units, University of Modena and Reggio Emilia, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Saffore', 'Affiliation': 'Health Economics and Outcomes Research, AbbVie Inc., 1 N Waukegan Road, Dept. ABV1-4NW-105-03, North Chicago, IL, 60064-6078, USA. christopher.saffore@abbvie.com.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Zueger', 'Affiliation': 'Health Economics and Outcomes Research, AbbVie Inc., 1 N Waukegan Road, Dept. ABV1-4NW-105-03, North Chicago, IL, 60064-6078, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'McDearmon-Blondell', 'Affiliation': 'Health Economics and Outcomes Research, AbbVie Inc., 1 N Waukegan Road, Dept. ABV1-4NW-105-03, North Chicago, IL, 60064-6078, USA.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Health Economics and Outcomes Research, AbbVie Inc., 1 N Waukegan Road, Dept. ABV1-4NW-105-03, North Chicago, IL, 60064-6078, USA.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'Department of Medicine, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.'}]",Rheumatology and therapy,['10.1007/s40744-021-00379-9']
1905,34635996,Niraparib: A Review in First-Line Maintenance Therapy in Advanced Ovarian Cancer.,"Niraparib (Zejula™) is a PARP inhibitor which is approved for maintenance therapy in adults with advanced ovarian cancer in complete or partial response to platinum-based chemotherapy. In a placebo-controlled phase III trial in patients with newly diagnosed advanced ovarian cancer, niraparib significantly extended progression free survival in two predefined populations, namely a patient population with altered homologous-recombination DNA repair pathways [i.e. homologous-recombination deficiency positive (HRd)] and the overall trial population. A prespecified exploratory subgroup analysis indicated that niraparib was also efficacious in patients who were homologous recombination deficiency negative or homologous recombination proficient (HRp). Niraparib has a manageable tolerability profile with myelosuppression as the main safety concern. Haematological reactions were managed with monitoring and dose reduction or interruption. A weight- and platelet count-based individualised dosage regimen introduced during the trial (and subsequently approved) appeared to improve haematological tolerability. Niraparib is a useful option for first-line maintenance therapy for advanced ovarian cancer in adults who responded to platinum-based chemotherapy, regardless of homologous-recombination deficiency status and is a promising option for HRp patients, for whom maintenance treatment options are limited.",2021,A prespecified exploratory subgroup analysis indicated that niraparib was also efficacious in patients who were homologous recombination deficiency negative or homologous recombination proficient (HRp).,"['adults with advanced ovarian cancer in complete or partial response to platinum-based chemotherapy', 'Advanced Ovarian Cancer', 'patients with newly diagnosed advanced ovarian cancer', 'advanced ovarian cancer in adults who responded to', 'patients who were homologous recombination deficiency negative or homologous recombination proficient (HRp']","['platinum-based chemotherapy', 'Niraparib', 'placebo', 'Niraparib (Zejula™']","['progression free survival', 'haematological tolerability', 'Haematological reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4473517', 'cui_str': 'Zejula'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.282663,A prespecified exploratory subgroup analysis indicated that niraparib was also efficacious in patients who were homologous recombination deficiency negative or homologous recombination proficient (HRp).,"[{'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]",Targeted oncology,['10.1007/s11523-021-00841-2']
1906,34637505,"Impact of supplementation with milk-cereal mix during 6-12 months of age on growth at 12 months: a 3-arm randomized controlled trial in Delhi, India.","BACKGROUND


A large proportion of infants in low- and middle-income countries are stunted. These infants are often fed complementary foods that are low-quality, primarily in terms of protein and micronutrients.
OBJECTIVES


We aimed to test 2 milk-cereal mixes supplemented with modest and high amounts of protein during 6-12 mo of age, compared with no supplementation, for their effect on length-for-age z score (LAZ) at 12 mo of age.
METHODS


Eligible infants (6 mo plus ≤29 d) were randomly assigned to either of the 2 interventions (modest- and high-protein) or a no supplement group. The milk-cereal mixes provided ∼125 kcal, 30%-45% energy from fats, and 80%-100% RDA of multiple micronutrients (MMN). The modest-protein group received 2.5 g protein [protein energy ratio (PER): 8%; 0.75 g from milk source] and the high-protein group received 5.6 g protein (PER: 18%, 1.68 g from milk source). One packet was given daily for 180 d. Counseling on continued breastfeeding and optimal infant-care practices was provided to all.
RESULTS


We enrolled 1548 infants (high-protein: n = 512; modest-protein: n = 519; and no supplement: n = 517). Compared with the no supplement group, there was an improvement in LAZ [adjusted mean difference (MD): 0.08; 95% CI: 0.01, 0.15], weight-for-age z score (MD: 0.12; 95% CI: 0.06, 0.19), weight-for-length z score (MD: 0.11; 95% CI: 0.02, 0.19), and midupper arm circumference z score (MD: 0.10; 95% CI: 0.02, 0.18) in the high-protein group at 12 mo of age. No significant differences for these anthropometric indicators were noted between the modest-protein and no supplement groups or between the high- and modest-protein groups.
CONCLUSIONS


Cereal mixes with higher amounts of milk-based protein and MMN may lead to improvement in linear growth and other anthropometric indexes in infants, compared with no supplementation.This trial was registered at ctri.nic.in as CTRI/2018/04/012932.",2021,"No significant differences for these anthropometric indicators were noted between the modest-protein and no supplement groups or between the high- and modest-protein groups.
","['Eligible infants (6 mo plus ≤29 d', '1548 infants (high-protein: n\xa0=\xa0512; modest-protein: n\xa0=\xa0519; and no supplement: n\xa0=\xa0517', 'during 6-12 months of age on growth at 12 months']","['milk-cereal mixes supplemented with modest and high amounts of protein during 6-12 mo of age, compared with no supplementation', '2 interventions (modest- and high-protein) or a no supplement group', 'supplementation with milk-cereal mix']","['weight-for-length z score', 'LAZ', 'weight-for-age z score']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",1548.0,0.076724,"No significant differences for these anthropometric indicators were noted between the modest-protein and no supplement groups or between the high- and modest-protein groups.
","[{'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Ravi P', 'Initials': 'RP', 'LastName': 'Upadhyay', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Ranadip', 'Initials': 'R', 'LastName': 'Chowdhury', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Department of Physiology, St John's Medical College, Bengaluru, India.""}, {'ForeName': 'Himani', 'Initials': 'H', 'LastName': 'Bhardwaj', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Tivendra', 'Initials': 'T', 'LastName': 'Kumar', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Dwarkanath', 'Affiliation': ""Department of Physiology, St John's Medical College, Bengaluru, India.""}, {'ForeName': 'Beena', 'Initials': 'B', 'LastName': 'Bose', 'Affiliation': ""Department of Physiology, St John's Medical College, Bengaluru, India.""}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Devi', 'Affiliation': ""Department of Physiology, St John's Medical College, Bengaluru, India.""}, {'ForeName': 'Gunjan', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Baljeet', 'Initials': 'B', 'LastName': 'Kaur', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab304']
1907,34644233,100% Watermelon Juice as a Food-First Intervention to Improve Cognitive Function: Ancillary Findings from a Randomized Controlled Trial.,"Lycopene exhibits neuroprotective properties due to its antioxidant and anti-inflammatory functionality. As watermelon is a rich source of lycopene, pasteurized watermelon juice provides lycopene in its most bioavailable form. This study examined relationships between circulating lycopene, cognitive performance, and biomarkers of oxidative stress and inflammation in response to pasteurized 100% watermelon juice supplementation. A placebo-controlled, randomized, double-blind, crossover trial was conducted with postmenopausal women ( n  = 16, 60 + 4.1 years). Participants consumed two 360 mL servings of pasteurized 100% watermelon juice or a placebo beverage for 4 weeks. Fasting blood samples were collected, and cognitive tests were administered to assess various neurocognitive domains. Statistical analyses included mixed models and Spearman correlations. Serum lycopene exhibited a significant treatment effect ( p  = 0.002) with a mean increase of 81%. However, this increase was not associated with changes in oxidative stress, inflammation, or cognitive function. Additional research is warranted to determine dose-durational effects for promoting cognition.",2021,Serum lycopene exhibited a significant treatment effect ( p  = 0.002) with a mean increase of 81%.,"['postmenopausal women ( n \u2009=\u200916, 60\u2009+\u20094.1\u2009years']","['pasteurized 100% watermelon juice or a placebo', 'placebo', 'Lycopene']","['Cognitive Function', 'oxidative stress, inflammation, or cognitive function', 'Fasting blood samples']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0874041', 'cui_str': 'Watermelon Preparation'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065331', 'cui_str': 'lycopene'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.505672,Serum lycopene exhibited a significant treatment effect ( p  = 0.002) with a mean increase of 81%.,"[{'ForeName': 'Kristi M', 'Initials': 'KM', 'LastName': 'Crowe-White', 'Affiliation': 'Department of Human Nutrition, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Vinoth Aryan', 'Initials': 'VA', 'LastName': 'Nagabooshanam', 'Affiliation': 'Nutrition Obesity Research Center, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Dudenbostel', 'Affiliation': 'Cardiovascular Disease, Vascular Biology & Hypertension, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Locher', 'Affiliation': 'Division of Gerontology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Tinsley P', 'Initials': 'TP', 'LastName': 'Chavers', 'Affiliation': 'Department of Human Nutrition, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Ellis', 'Affiliation': 'Department of Human Nutrition, University of Alabama, Tuscaloosa, Alabama, USA.'}]",Journal of nutrition in gerontology and geriatrics,['10.1080/21551197.2021.1988028']
1908,34636112,The safety of activated eptacog beta in the management of bleeding episodes and perioperative haemostasis in adult and paediatric haemophilia patients with inhibitors.,"INTRODUCTION


Haemophilia patients with inhibitors often require a bypassing agent (BPA) for bleeding episode management. Eptacog beta (EB) is a new FDA-approved recombinant activated human factor VII BPA for the treatment and control of bleeding in haemophilia A or B patients with inhibitors (≥12 years of age). We describe here the EB safety profile from the three prospective Phase 3 clinical trials performed to date.
AIM


To assess EB safety, immunogenicity and thrombotic potential in children and adults who received EB for treatment of bleeding and perioperative care.
METHODS


Using a randomized crossover design, 27 subjects in PERSEPT 1 (12-54 years) and 25 subjects in PERSEPT 2 (1-11 years) treated bleeding episodes with 75 or 225 μg/kg EB initially followed by 75 μg/kg dosing at predefined intervals as determined by clinical response. Twelve PERSEPT 3 subjects (2-56 years) received an initial preoperative infusion of 75 μg/kg (minor procedures) or 200 μg/kg EB (major surgeries) with subsequent 75 μg/kg doses administered intraoperatively and post-operatively as indicated. Descriptive statistics were used for data analyses.
RESULTS


Sixty subjects who received 3388 EB doses in three trials were evaluated. EB was well tolerated, with no allergic, hypersensitivity, anaphylactic or thrombotic events reported and no neutralizing anti-EB antibodies detected. A death occurred during PERSEPT 3 and was determined to be unlikely related to EB treatment by the data monitoring committee.
CONCLUSION


Results from all three Phase 3 trials establish an excellent safety profile of EB in haemophilia A or B patients with inhibitors for treatment of bleeding and perioperative use.",2021,"EB was well tolerated, with no allergic, hypersensitivity, anaphylactic or thrombotic events reported and no neutralizing anti-EB antibodies detected.","['27 subjects in PERSEPT 1 (12-54 years) and 25 subjects in PERSEPT 2 (1-11 years) treated bleeding episodes with 75 or 225\xa0μg/kg EB initially followed by 75\xa0μg/kg dosing at predefined intervals as determined by clinical response', 'Haemophilia patients with inhibitors often require a bypassing agent (BPA) for bleeding episode management', 'children and adults who received EB for treatment of bleeding and perioperative care', 'Sixty subjects who received 3388\xa0EB doses in three trials were evaluated', 'adult and paediatric haemophilia patients with inhibitors', 'haemophilia A or B patients with inhibitors (≥12 years of age']",['initial preoperative infusion of 75\xa0μg/kg (minor procedures) or 200\xa0μg/kg EB (major surgeries) with subsequent 75\xa0μg/kg doses administered intraoperatively and post-operatively as indicated'],"['EB safety, immunogenicity and thrombotic potential', 'tolerated, with no allergic, hypersensitivity, anaphylactic or thrombotic events', 'safety profile of EB']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",60.0,0.0434184,"EB was well tolerated, with no allergic, hypersensitivity, anaphylactic or thrombotic events reported and no neutralizing anti-EB antibodies detected.","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Escobar', 'Affiliation': 'Gulf States Hemophilia and Thrombophilia Center, Houston, Texas, USA.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Castaman', 'Affiliation': 'Center for Bleeding Disorders and Coagulation, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Santiago Bonanad', 'Initials': 'SB', 'LastName': 'Boix', 'Affiliation': 'University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Callaghan', 'Affiliation': 'Central Michigan University, Detroit, Michigan, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'de Moerloose', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ducore', 'Affiliation': 'Hematology/Oncology Clinic, University of California at Davis, Sacramento, California, USA.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Hermans', 'Affiliation': 'Cliniques Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Janna', 'Initials': 'J', 'LastName': 'Journeycake', 'Affiliation': 'Oklahoma Bleeding and Clotting Disorders Center at OU Health, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Leissinger', 'Affiliation': 'Section of Hematology/Oncology, Tulane University School of Medicine, New Orleans, Louisiana, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Luck', 'Affiliation': 'Orthopaedic Hemophilia Treatment Center, Los Angeles, California, USA.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Mahlangu', 'Affiliation': 'Hemophilia Comprehensive Care Center, University of the Witwatersrand and National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Miesbach', 'Affiliation': 'Goethe University Hospital, Frankfurt, Germany.'}, {'ForeName': 'Ismail Haroon', 'Initials': 'IH', 'LastName': 'Mitha', 'Affiliation': 'Lakeview Hospital, Benoni, Gauteng, South Africa.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Négrier', 'Affiliation': 'Edouard Herriot University Hospital, Lyon, France.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Quon', 'Affiliation': 'Orthopaedic Hemophilia Treatment Center, Los Angeles, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Recht', 'Affiliation': 'American Thrombosis and Hemostasis Network, Rochester, New York, USA.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Schved', 'Affiliation': 'Haemophilia Treatment Centre, University Hospital Montpellier, Montpellier, France.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Shapiro', 'Affiliation': 'Indiana Hemophilia and Thrombosis Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sidonio', 'Affiliation': 'Aflac Cancer and Blood Disorders Center, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Oleksandra', 'Initials': 'O', 'LastName': 'Stasyshyn', 'Affiliation': 'Institute of Blood Pathology and Transfusion Medicine, Lviv, Ukraine.'}, {'ForeName': 'Kateryna V', 'Initials': 'KV', 'LastName': 'Vilchevska', 'Affiliation': ""National Specialized Children's Hospital Okhmatdyt, Kyiv, Ukraine.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado, Aurora, Colorado, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, California, USA.""}, {'ForeName': 'W Allan', 'Initials': 'WA', 'LastName': 'Alexander', 'Affiliation': 'Aoede Associates, Athens, Texas, USA.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Sabbagh', 'Affiliation': 'LFB-USA, Inc., Framingham, Massachusetts, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bonzo', 'Affiliation': 'LFB-USA, Inc., Framingham, Massachusetts, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Macie', 'Affiliation': 'HEMA Biologics, LLC, Louisville, Kentucky, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wilkinson', 'Affiliation': 'GLOVAL LLC, Broomfield, Colorado, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Kessler', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, District of Columbia, USA.'}]",Haemophilia : the official journal of the World Federation of Hemophilia,['10.1111/hae.14419']
1909,31818809,"Response to: 'Comment on 'Sustained discontinuation of infliximab with a raising-dose strategy after obtaining remission in patients with rheumatoid arthritis: the RRRR study, a randomised controlled trial' by Tanaka  et al ' by Berkhout  et al .",,2021,,['patients with rheumatoid arthritis'],['infliximab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}]",[],,0.121784,,"[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Oba', 'Affiliation': 'Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Rheumatology, Keio Univ, School of Medicine, Tokyo, Japan.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216593']
1910,34641950,Impact of interprofessional service-learning on the effectiveness of knowledge transfer of antimicrobial resistance to Hong Kong elders: a quasi-experiment.,"BACKGROUND


Community perception on antimicrobials plays a role in driving the development of antimicrobial resistance (AMR). The aim of the study was to evaluate the impact of interprofessional service-learning on the effectiveness of AMR knowledge transfer in Hong Kong elders aged 65 or above and students from university and secondary schools.
METHODS


A quasi-experimental pretest-posttest controlled study was carried out from July 2018 to March 2019 for elderly subjects and a pre- and post-test were conducted in students from May to August 2018. Elderly subjects were recruited from the university-based community outreach program. The community outreach team consisted of both university and secondary school students. Students were provided with training of geriatric care and AMR before they reached out to the community. The one-to-one intervention with the aid of video and verbal explanation to educate the elderly about the definition, causes, and consequences of AMR, and preventive measures against AMR was provided. Questionnaires on knowledge of antibiotics and AMR were used as tools to reflect on the effectiveness for both students and elderly subjects. The questionnaire was completed twice, before and 1 week after the intervention. Chi-square test, t tests and regression analysis were used to analyze the data.
RESULTS


A total of 93 Chinese elders, 61 of them in the intervention group and 32 in the control group participated in the study. The score obtained by the intervention group increased from 40.1 to 83.3% (p < 0.001) following intervention, while that of control group increased from 33.0 to 44.0% (p < 0.001). The increase attained in the intervention group was significantly greater than that of the control group (p < 0.001). A total of 95 secondary students and 88 university students have completed the pre-post questionnaires with 42.21% and 13% increment in AMR knowledge after the training (p < 0.001).
CONCLUSION


The significant change in knowledge level showed effective AMR knowledge transfer to both elders and students. The study could be used as a reference when allocating resources to implement effective interprofessional service-learning for better community health education in elderly populations.
TRIAL REGISTRATION


This study was approved by the Chinese University of Hong Kong Survey and Behavioural Research Ethics Committee in December 2018 (Ref no. SBRE-18-214).",2021,The increase attained in the intervention group was significantly greater than that of the control group (p < 0.001).,"['A quasi-experimental pretest-posttest controlled study was carried out from July 2018 to March 2019 for elderly subjects and a pre- and post-test were conducted in students from May to August 2018', '95 secondary students and 88 university students', 'Elderly subjects were recruited from the university-based community outreach program', '93 Chinese elders, 61 of them in the intervention group and 32 in the control group participated in the study', 'students and elderly subjects', 'Hong Kong elders', 'Hong Kong elders aged 65 or above and students from university and secondary schools', 'Chinese University of Hong Kong Survey and Behavioural Research Ethics Committee in December 2018', 'elderly populations']",['interprofessional service-learning'],['AMR knowledge'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",93.0,0.00823869,The increase attained in the intervention group was significantly greater than that of the control group (p < 0.001).,"[{'ForeName': 'Anna C Y', 'Initials': 'ACY', 'LastName': 'Lo', 'Affiliation': 'School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong.'}, {'ForeName': 'Joyce T S', 'Initials': 'JTS', 'LastName': 'Li', 'Affiliation': 'Centre for Learning Enhancement And Research, The Chinese University of Hong Kong (CLEAR), Room 502 Hui Yeung Shing Building, Shatin, N.T., Hong Kong.'}, {'ForeName': 'Janita P C', 'Initials': 'JPC', 'LastName': 'Chau', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong.'}, {'ForeName': 'Samuel Y S', 'Initials': 'SYS', 'LastName': 'Wong', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong.'}, {'ForeName': 'David S C', 'Initials': 'DSC', 'LastName': 'Hui', 'Affiliation': 'Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong.'}, {'ForeName': 'Vivian W Y', 'Initials': 'VWY', 'LastName': 'Lee', 'Affiliation': 'Centre for Learning Enhancement And Research, The Chinese University of Hong Kong (CLEAR), Room 502 Hui Yeung Shing Building, Shatin, N.T., Hong Kong. vivianlee@cuhk.edu.hk.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-021-01011-9']
1911,34637858,Low-dose midazolam for anxiolysis for pregnant women undergoing cesarean delivery: a randomized trial.,"INTRODUCTION


Anxiety and fear are common among pregnant women undergoing cesarean delivery. In addition to psychologically unpleasant, they can elicit endocrine and metabolic changes. Administration of benzodiazepines in this patient group is uncommon and investigation focusing on the topic is rare. This study aimed to determine anxiolysis efficacy of low-dose midazolam administered preoperatively, right before cesarean delivery, and to evaluate whether its administration impacts neonatal vitality, maternal consciousness, and recall of the moment the baby was born.
METHODS


Fifty pregnant women with indication for cesarean delivery were included in this randomized, double-blind, placebo-controlled clinical study and allocated into two groups of 25 participants each (Midazolam and Control group). Midazolam (0.0125 mg.kg -1 ) or a placebo solution was administered immediately before spinal anesthesia and the anxiolytic effect was assessed using a visual analogue scale before and after administration. We registered the Apgar score at 1 and 5 minutes, the Ramsay scale and recall of the moment of birth, that was assessed 90 minutes after birth.
RESULTS


Pregnant women from the Midazolam group presented a 1.3-point reduction in anxiety on the visual analogue scale, while the Control group showed virtually no change (p = 0.027). We observed no statistically significant changes in Apgar scores, level of maternal consciousness and recall of the moment of delivery.
CONCLUSIONS


Low-dose midazolam can provide anxiety management in pregnant women undergoing cesarean delivery with no significant undesirable effects.",2021,"RESULTS


Pregnant women from the Midazolam group presented a 1.3-point reduction in anxiety on the visual analogue scale, while the Control group showed virtually no change (p = 0.027).","['Pregnant women', 'Fifty pregnant women with indication for cesarean delivery', 'pregnant women undergoing cesarean delivery']","['benzodiazepines', 'low-dose midazolam', 'Low-dose midazolam', 'Midazolam', 'midazolam', 'placebo solution', 'placebo']","['anxiety on the visual analogue scale', 'anxiolysis efficacy', 'Apgar scores, level of maternal consciousness and recall of the moment of delivery', 'Apgar score at 1 and 5-minutes, the Ramsay scale and recall of the moment of birth']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1961138', 'cui_str': 'Induction of minimal sedation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",50.0,0.208149,"RESULTS


Pregnant women from the Midazolam group presented a 1.3-point reduction in anxiety on the visual analogue scale, while the Control group showed virtually no change (p = 0.027).","[{'ForeName': 'Pedro Solfa Campos', 'Initials': 'PSC', 'LastName': 'Oliveira', 'Affiliation': 'Pontifícia Universidade Católica de Campinas, Programa de Pós-graduação em Ciências da Saúde, Campinas, SP, Brazil; Hospital da Pontifícia Universidade Católica de Campinas, Serviço de Anestesiologia, Campinas, SP, Brazil. Electronic address: pscoliveira@gmail.com.'}, {'ForeName': 'Beatriz Cesar', 'Initials': 'BC', 'LastName': ""Sant'Anna"", 'Affiliation': 'Hospital da Pontifícia Universidade Católica de Campinas, Serviço de Anestesiologia, Campinas, SP, Brazil.'}, {'ForeName': 'Náira Bueno', 'Initials': 'NB', 'LastName': 'Seixas', 'Affiliation': 'Hospital da Pontifícia Universidade Católica de Campinas, Serviço de Anestesiologia, Campinas, SP, Brazil.'}, {'ForeName': 'José Alexandre', 'Initials': 'JA', 'LastName': 'Mendonça', 'Affiliation': 'Pontifícia Universidade Católica de Campinas, Programa de Pós-graduação em Ciências da Saúde, Campinas, SP, Brazil; Hospital da Pontifícia Universidade Católica de Campinas, Serviço de Reumatologia, Campinas, SP, Brazil.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2021.07.039']
1912,34637849,Resistant fabric warming is a viable alternative to forced-air warming to prevent inadvertent perioperative hypothermia during hemiarthroplasty in the elderly.,"BACKGROUND


Surgical site infection (SSI) is associated with inadvertent perioperative hypothermia (IPH). This can be prevented by active patient warming. However, results from comparisons of warming techniques are conflicting. They are based mostly on elective surgery, are from small numbers of patients, and are dominated by the market leader, forced-air warming (FAW). Furthermore, the definition of hypothermia is debatable and systematic reviews of warming systems conclude that a stricter control of temperature is required to study the benefits of warming.
AIM


To analyse core temperatures in detail in a large subset of elderly patients who took part in a randomized trial of patient warming following hemiarthroplasty who had received constant zero-flux thermometry to record their temperature.
METHODS


Regression models with a fixed effect for warming group and covariates related to temperature were compared for 257 participants randomized to FAW or resistant fabric warming (RFW) from a prior clinical trial.
FINDINGS


Those in the RFW group were -0.08°C cooler and had a cumulative hypothermia score -1.87 lower than those in the FAW group. There was no difference in the proportion of hypothermic patients at either <36.5°C or <36.0°C.
CONCLUSIONS


This is the first study to provide accurate temperature measurements in patients undergoing a procedure predominantly under regional rather than general anaesthetic. It shows that RFW is a viable alternative to FAW for preventing IPH during hemiarthroplasty. Further studies are needed to measure the benefits of patient warming in terms of clinically important outcomes.",2021,It shows that RFW is a viable alternative to FAW for preventing IPH during hemiarthroplasty.,"['257 participants randomised to', 'patients undergoing a procedure predominantly under regional rather than general anaesthetic', 'elderly patients who took part in a randomised trial of patient warming following hemiarthroplasty who had received constant zero-flux thermometry to record their temperature']","['FAW or Resistant Fabric Warming (RFW', 'RFW']",['cumulative hypothermia score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0178862', 'cui_str': 'Thermometry'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}]","[{'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",257.0,0.0838898,It shows that RFW is a viable alternative to FAW for preventing IPH during hemiarthroplasty.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kümin', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'C I', 'Initials': 'CI', 'LastName': 'Jones', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Woods', 'Affiliation': 'Milton Keynes University Hospitals NHS Foundation Trust, Milton Keynes, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reed', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scarborough', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Harper', 'Affiliation': 'University Hospitals Sussex NHS Foundation Trust, Brighton, UK. Electronic address: mark.harper@doctors.org.uk.'}]",The Journal of hospital infection,['10.1016/j.jhin.2021.10.005']
1913,34637848,Effectiveness of an intensive community-based intervention for people with type 2 diabetes in Indonesia: A pilot study.,"AIMS


This pilot study aimed to assess the acceptability of an intensive community-based intervention, and to get a preliminary estimate of the effect size of the intervention for people with type 2 diabetes in Kupang, Indonesia.
METHODS


Pilot of a cluster randomised trial involving sixty-seven participants. The participants were recruited from four Primary Health Centres (PHCs), and were allocated into groups (intervention: 36; control: 31) based on the PHCs they were registered in. The 3-month intervention consisted of weekly group activities including physical activity and education. Control was usual care. The outcomes were change in HbA1c, medication adherence, and self-management behaviours. To test our intervention, we used a mixed linear model, with participants nested within cluster/health centre.
RESULTS


Participants were 60% female, mean age 57, and had diabetes for an average of 4.5 years. Groups did not differ at baseline. Counter to prediction, no effects of the intervention over usual care were observed on the outcomes measured. However, both groups made statistically significant improvements in HbA1c (intervention from 8.3% ± 1.9 to 7.8% ± 1.8; control from 8.4% ± 2.6 to 7.9% ± 2.5).
CONCLUSIONS


The effect of the intervention did not differ from usual care. However, both groups made improvements in HbA1c outcome, suggesting that the project might have indirectly triggered more intensive care for diabetes patients.",2021,"However, both groups made statistically significant improvements in HbA1c (intervention from 8.3%±1.9 to 7.8%±1.8; control from 8.4%±2.6 to 7.9%±2.5).
","['Participants were 60% female, mean age 57, and had diabetes for an average of 4.5 years', 'people with type 2 diabetes in Indonesia', 'participants were recruited from four Primary Health Centres (PHCs), and were allocated into groups (intervention: 36; control: 31) based on the PHCs they were registered in', 'Pilot of a cluster randomised trial involving sixty-seven participants', 'diabetes patients', 'people with type-2-diabetes in Kupang, Indonesia']","['intensive community-based intervention', 'weekly group activities including physical activity and education']","['change in HbA1c, medication adherence, and self-management behaviours']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",67.0,0.0202601,"However, both groups made statistically significant improvements in HbA1c (intervention from 8.3%±1.9 to 7.8%±1.8; control from 8.4%±2.6 to 7.9%±2.5).
","[{'ForeName': 'Anna Wahyuni', 'Initials': 'AW', 'LastName': 'Widayanti', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand; Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Heydon', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Green', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand; School of Allied Health and Physical Activity for Health, Health Research Institute (HRI), University of Limerick, Limerick, Ireland. Electronic address: James.Green@ul.ie.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Norris', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2021.109087']
1914,34637770,Hunger increases negative and decreases positive emotions in women with a healthy weight.,"The term 'hangry' is colloquially used to describe being ""bad tempered or irritable as a result of hunger,"" but remarkably few studies have examined the effect of hunger on emotions. Yet, women attempting to restrict their food intake may be at risk of becoming entangled in a vicious cycle of hunger and negative emotions. That is, hunger may lead to negative emotions, which can lead to overeating and overeating can, in turn, provoke subsequent restriction leading to more hunger. Therefore the aim of this study was to examine the effect of hunger on positive and negative emotions in women with a healthy BMI, and the role of subclinical eating disorder symptoms in this effect. We randomly assigned women to a hunger condition (fasting for 14 h, n = 53) or satiated condition (eat breakfast before the study, n = 55), and they completed the Eating Disorder Examination Questionnaire and the Profile of Mood States in the lab. Hungry women reported overall higher negative emotions (higher tension, anger, fatigue, and confusion) and lower positive emotions (lower vigour and marginally lower esteem-related affect) than satiated women. Moreover, for satiated but not for hungry women, higher eating disorder symptoms were associated with lower esteem-related affect. These findings show that food restriction leads to negative emotions, and practitioners and individuals should be aware of these implications of food restriction on mental health. Second, clinicians and individuals should be wary of relatively low esteem-related affect when satiated in individuals with eating disorder symptoms, as it could serve as a maintaining factor in eating pathology.",2021,"Hungry women reported overall higher negative emotions (higher tension, anger, fatigue, and confusion) and lower positive emotions (lower esteem-related affect and vigour) than satiated women.","['Hungry women', 'women with a healthy BMI', 'women with a healthy weight']","['hunger condition (fasting for 14\u202fh, n\u202f=\u202f53) or satiated condition (eat breakfast']","['positive emotions', 'eating disorder symptoms', 'Eating Disorder Examination Questionnaire', 'negative emotions (higher tension, anger, fatigue, and confusion) and lower positive emotions']","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C2960501', 'cui_str': 'Eating disorder examination questionnaire'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.0108646,"Hungry women reported overall higher negative emotions (higher tension, anger, fatigue, and confusion) and lower positive emotions (lower esteem-related affect and vigour) than satiated women.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Ackermans', 'Affiliation': 'University of Groningen, Department of Clinical Psychology and Experimental Psychopathology, the Netherlands.'}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Jonker', 'Affiliation': 'University of Groningen, Department of Clinical Psychology and Experimental Psychopathology, the Netherlands. Electronic address: n.c.jonker@rug.nl.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Bennik', 'Affiliation': 'University of Groningen, Department of Clinical Psychology and Experimental Psychopathology, the Netherlands.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'de Jong', 'Affiliation': 'University of Groningen, Department of Clinical Psychology and Experimental Psychopathology, the Netherlands.'}]",Appetite,['10.1016/j.appet.2021.105746']
1915,34643887,The Effect of Adding a Training Device and Smartphone Application to Traditional Verbal Counseling in Asthmatic Children.,"INTRODUCTION


New training devices have been introduced to help in inhaler counseling by addressing the inspiratory flow through the metered-dose inhaler (MDI), which is the most important problem of the MDI inhalation technique. This study aims to compare the effects of MDI traditional verbal counseling and advanced counseling using training devices with a smartphone application in pediatric asthmatic patients.
METHODS


A total of 201 pediatric asthmatic subjects (8-18 years) were divided into two groups: a verbal counseling group, who received only MDI verbal counseling training (n = 101), and an advanced counseling group who received counseling using a training device (Flo-Tone with Trainhaler smartphone application) in addition to the traditional MDI verbal counseling (n = 100). Every patient in the two groups attended three counseling visits, 1 month apart. At each visit, pulmonary functions [peak expiratory flow (PEF), forced expiratory volume in 1 s (FEV 1 ) as % of predicted] were measured. Also, patients were asked to perform their normal inhalation technique using their MDI, and mistakes were detected and recorded by the investigator. Then, patients were trained on the correct steps of the MDI inhalation technique using either verbal counseling or advanced counseling depending on their study group. In the advanced group, the Flo-Tone was connected to the mouthpiece of the MDI to blow a whistle while the patient inhaled from the MDI. That whistle was detected by the Trainhaler smartphone application and the duration of inhalation determined by the application was recorded.
RESULTS


Both groups showed a gradual significant decrease (p < 0.05) in the total mean number of MDI inhalation technique mistakes from the second visit of counseling, and the improvement continued in the third visit, with a lower number of mistakes in the advanced group especially in inhaling at a slow rate until the lungs are a full step. Also, the advanced counseling group showed a gradual significant increase (p < 0.05) in lung function (PEF and FEV1% of predicted) from the second visit of counseling, particularly (FEV1% predicted) results which showed a greater and more rapid overall improvement in the advanced group compared to the limited overall improvements that occurred in the control group, while significant improvement (p < 0.05) of lung function was obtained at the third visit in the verbal counseling group. In the advanced group, the number of seconds measured by the smartphone application, which represents the duration of inhalation, increased significantly (p < 0.05) in the second and third visits.
CONCLUSIONS


The addition of training devices and smartphone applications to traditional verbal counseling of MDI inhalation technique in asthmatic children resulted in significant improvements in lung function (especially in FEV1% of predicted results), and duration of inhalation, and progressive decreases in the average number of MDI inhalation techniques errors compared to the verbal counseling group.",2021,"Also, the advanced counseling group showed a gradual significant increase (p < 0.05) in lung function (PEF and FEV1% of predicted) from the second visit of counseling, particularly (FEV1% predicted) results which showed a greater and more rapid overall improvement in the advanced group compared to the limited overall improvements that occurred in the control group, while significant improvement (p < 0.05) of lung function was obtained at the third visit in the verbal counseling group.","['pediatric asthmatic patients', 'Asthmatic Children', '201 pediatric asthmatic subjects (8-18\xa0years', 'asthmatic children']","['advanced counseling group who received counseling using a training device (Flo-Tone with Trainhaler smartphone application) in addition to the traditional MDI verbal counseling', 'verbal counseling group, who received only MDI verbal counseling training', 'MDI traditional verbal counseling and advanced counseling', 'MDI inhalation technique using either verbal counseling or advanced counseling', 'Training Device and Smartphone Application to Traditional Verbal Counseling']","['lung function', 'Trainhaler smartphone application and the duration of inhalation', 'pulmonary functions [peak expiratory flow (PEF), forced expiratory volume in 1 s (FEV 1 ', 'total mean number of MDI inhalation technique mistakes', 'duration of inhalation']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique'}]",201.0,0.0070689,"Also, the advanced counseling group showed a gradual significant increase (p < 0.05) in lung function (PEF and FEV1% of predicted) from the second visit of counseling, particularly (FEV1% predicted) results which showed a greater and more rapid overall improvement in the advanced group compared to the limited overall improvements that occurred in the control group, while significant improvement (p < 0.05) of lung function was obtained at the third visit in the verbal counseling group.","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tony', 'Affiliation': 'Beni-Suef Specialized Hospital, Beni-Suef, Egypt.'}, {'ForeName': 'Mona A', 'Initials': 'MA', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Hasnaa', 'Initials': 'H', 'LastName': 'Osama', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Marwa O', 'Initials': 'MO', 'LastName': 'Elgendy', 'Affiliation': 'Department of Clinical Pharmacy, Teaching Hospital of Faculty of Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Mohamed E A', 'Initials': 'MEA', 'LastName': 'Abdelrahim', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt. mohamed.abdelrahim@pharm.bsu.edu.eg.'}]",Pulmonary therapy,['10.1007/s41030-021-00176-3']
1916,34642494,"Safety, tolerability and antiviral activity of the antisense oligonucleotide bepirovirsen in patients with chronic hepatitis B: a phase 2 randomized controlled trial.","Chronic infection with hepatitis B virus (HBV) leads to an increased risk of death from cirrhosis and hepatocellular carcinoma. Functional cure rates are low with current treatment options (nucleos(t)ide analogs (NAs) and pegylated interferons). Bepirovirsen is an antisense oligonucleotide targeting all HBV messenger RNAs; in cell culture and animal models, bepirovirsen leads to reductions in HBV-derived RNAs, HBV DNA and viral proteins. This phase 2 double-blinded, randomized, placebo-controlled trial is the first evaluation of the safety and activity of an antisense oligonucleotide targeting HBV RNA in both treatment-naïve and virally suppressed individuals with chronic HBV infection. The primary objective was to assess the safety and tolerability of bepirovirsen in individuals with chronic hepatitis B (CHB) (NCT02981602). The secondary objective was to assess antiviral activity, including the change from baseline to day 29 in serum hepatitis B surface antigen (HBsAg) concentration. Participants with CHB infection ≥6 months and serum HBsAg ≥50 IU ml -1  were enrolled from seven centers across Hong Kong and the Republic of Korea and randomized (3:1 within each dose cohort) to receive bepirovirsen or placebo via subcutaneous injection twice weekly during weeks 1 and 2 (days 1, 4, 8 and 11) and once weekly during weeks 3 and 4 (days 15 and 22). Participants were then followed for 26 weeks. Twenty-four participants were treatment-naïve and seven were receiving stable NA therapy. Treatment-emergent adverse events were mostly mild/moderate (most commonly injection site reactions). Eleven (61.1%) and three (50.0%) treatment-naïve participants experienced one or more treatment-emergent adverse event in the bepirovirsen and placebo groups, respectively. In participants receiving NA therapy, the corresponding numbers were three (60.0%) and one (50.0%). Transient, self-resolving alanine aminotransferase flares (≥2× upper limit of normal) were observed in eight treatment-naïve participants and three participants on stable NA regimens in the bepirovirsen treatment arms. HBsAg reductions were observed and were significant versus placebo for treatment-naïve participants receiving bepirovirsen 300 mg (P = 0.001), but not for the bepirovirsen 150 mg group (P = 0.245) or participants receiving stable NA therapy (P = 0.762). Two participants in each of the 300 mg dose groups achieved HBsAg levels below the lower limit of quantitation by day 29 (n = 3) or day 36 (n = 1). Bepirovirsen had a favorable safety profile. These preliminary observations warrant further investigation of the safety and activity of bepirovirsen in a larger CHB patient population.",2021,"treatment-naïve participants experienced one or more treatment-emergent adverse event in the bepirovirsen and placebo groups, respectively.","['individuals with chronic HBV infection', 'Twenty-four participants were treatment-naïve and seven were receiving stable NA therapy', 'Chronic infection with hepatitis B virus (HBV', 'ml -1  were enrolled from seven centers across Hong Kong and the Republic of Korea and randomized (3:1 within each dose cohort) to receive', 'patients with chronic hepatitis B', 'Participants with CHB infection ≥6 months and serum HBsAg', 'individuals with chronic hepatitis B (CHB) (NCT02981602']","['bepirovirsen or placebo', 'placebo', 'antisense oligonucleotide bepirovirsen', 'Bepirovirsen']","['serum hepatitis B surface antigen (HBsAg) concentration', 'Transient, self-resolving alanine aminotransferase flares', 'HBsAg levels', 'Functional cure rates', 'HBsAg reductions', 'Safety, tolerability and antiviral activity', 'safety and tolerability of bepirovirsen', 'antiviral activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0151317', 'cui_str': 'Chronic infectious disease'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C2744579', 'cui_str': 'ATP8A2 protein, human'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079925', 'cui_str': 'Antisense oligonucleotide'}]","[{'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",24.0,0.512788,"treatment-naïve participants experienced one or more treatment-emergent adverse event in the bepirovirsen and placebo groups, respectively.","[{'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Yuen', 'Affiliation': 'Department of Medicine and State Key Laboratory of Liver Research, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China. mfyuen@hkucc.hku.hk.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Heo', 'Affiliation': 'College of Medicine, Pusan National University and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Jeong-Won', 'Initials': 'JW', 'LastName': 'Jang', 'Affiliation': ""Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Oh', 'Initials': 'YO', 'LastName': 'Kweon', 'Affiliation': 'Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Sung-Jae', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Inje University Busan Paik Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Tami', 'Affiliation': 'Ionis Pharmaceuticals Inc, Carlsbad, CA, USA.'}, {'ForeName': 'Shihyun', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Yates', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cremer', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Elston', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Dickens', 'Initials': 'D', 'LastName': 'Theodore', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Paff', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'C Frank', 'Initials': 'CF', 'LastName': 'Bennett', 'Affiliation': 'Ionis Pharmaceuticals Inc, Carlsbad, CA, USA.'}, {'ForeName': 'T Jesse', 'Initials': 'TJ', 'LastName': 'Kwoh', 'Affiliation': 'Ionis Pharmaceuticals Inc, Carlsbad, CA, USA.'}]",Nature medicine,['10.1038/s41591-021-01513-4']
1917,34648192,Cytochrome P450 1A2 is the most important enzyme for hepatic metabolism of the metamizole metabolite 4-methylaminoantipyrine.,"AIMS


Metamizole (dipyrone) is a prodrug not detectable in serum or urine after oral ingestion. The primary metabolite, 4-methylaminoantipyrine (4-MAA), can be N-demethylated to 4-aminoantipyrine (4-AA) or oxidized to 4-formylaminoantipyrine (4-FAA) by cytochrome P450 (CYP)-dependent reactions. We aimed to identify the CYPs involved in 4-MAA metabolism and to quantify the effect of CYP inhibition on 4-MAA metabolism.
METHODS


We investigated the metabolism of 4-MAA in vitro using CYP expressing supersomes and the pharmacokinetics of metamizole in the presence of CYP inhibitors in male subjects.
RESULTS


The experiments in supersomes revealed CYP1A2 as the major CYP for 4-MAA N-demethylation and 4-FAA formation with CYP2C19 and CYP2D6 contributing to N-demethylation. In the clinical study, we investigated the influence of ciprofloxacin (CYP1A2 inhibitor), fluconazole (CYP2C19 inhibitor) and the combination ciprofloxacin/fluconazole on the pharmacokinetics of metamizole in n = 12 male subjects in a randomized, placebo-controlled, double-blind study. The geometric mean ratios for the area under the concentration-time curve of 4-MAA after/before treatment were 1.17 (90% CI 1.09-1.25) for fluconazole, 1.51 (90% CI 1.42-1.60) for ciprofloxacin and 1.92 (90% CI 1.81-2.03) for ciprofloxacin/fluconazole. Fluconazole increased the half-life of 4-MAA from 3.22 hours by 0.47 hours (95% CI 0.13-0.81, P < .05), ciprofloxacin by 0.69 hours (95% CI 0.44-0.94, P < .001) and fluconazole/ciprofloxacin by 2.85 hours (95% CI 2.48-3.22, P < .001).
CONCLUSION


CYP1A2 is the major CYP for the conversion of 4-MAA to 4-AA and 4-FAA. The increase in 4-MAA exposure by the inhibition of CYP1A2 and by the combination CYP1A2/CYP2C19 may be relevant for dose-dependent adverse reactions of 4-MAA.",2021,"Fluconazole increased the half-life of 4-MAA from 3.22 h by 0.47 h (95% CI 0.13-0.81, p<0.05), ciprofloxacin by 0.69 h (95% CI 0.44-0.94, p<0.001) and fluconazole/ciprofloxacin by 2.85 h (95% CI 2.48-3.22, p<0.001).
","['male subjects', 'n=12 male subjects']","['ciprofloxacin', 'Metamizole (dipyrone', 'ciprofloxacin (CYP1A2 inhibitor), fluconazole (CYP2C19 inhibitor', 'fluconazole/ciprofloxacin', 'Cytochrome P450', 'Fluconazole', 'placebo', 'fluconazole', 'ciprofloxacin/fluconazole']","['half-life of 4-MAA', 'geometric mean ratios for the area under the concentration-time curve', '4-MAA exposure']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0012586', 'cui_str': 'Dipyrone'}, {'cui': 'C3850068', 'cui_str': 'CYP1A2 Inhibitors'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C3850059', 'cui_str': 'Cytochrome P450 2C19 inhibitor'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0068957', 'cui_str': 'noramidopyrine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",12.0,0.0655284,"Fluconazole increased the half-life of 4-MAA from 3.22 h by 0.47 h (95% CI 0.13-0.81, p<0.05), ciprofloxacin by 0.69 h (95% CI 0.44-0.94, p<0.001) and fluconazole/ciprofloxacin by 2.85 h (95% CI 2.48-3.22, p<0.001).
","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Bachmann', 'Affiliation': 'Division of Clinical Pharmacology & Toxicology, University Hospital, Basel, Switzerland.'}, {'ForeName': 'Henriette E', 'Initials': 'HE', 'LastName': 'Meyer Zu Schwabedissen', 'Affiliation': 'Biopharmacy, Department of Pharmaceutical Sciences, University of Basel, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Duthaler', 'Affiliation': 'Division of Clinical Pharmacology & Toxicology, University Hospital, Basel, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Krähenbühl', 'Affiliation': 'Division of Clinical Pharmacology & Toxicology, University Hospital, Basel, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.15108']
1918,34649266,Twelve Months of Time-restricted Eating and Resistance Training Improves Inflammatory Markers and Cardiometabolic Risk Factors.,"INTRODUCTION


Recently, a modified intermittent fasting protocol was demonstrated to be able to maintain muscle mass and strength, decrease fat mass, and improve some inflammation and cardiovascular risk factors in healthy resistance-trained males after 2 months. The present study sought to investigate the long-term effects on these parameters.
METHODS


The experiment was a single-blind randomized study. Twenty healthy subjects were enrolled and underwent 12 months of either a time-restricted eating (TRE) diet or a normal diet (ND) protocol, along with resistance training. In the TRE protocol, subjects consumed their energy needs in three meals during an 8-h period of time each day (1 pm, 4 pm, and 8 pm). Subjects in the ND group also had three meals, which were consumed at 8 am, 1 pm, and 8 pm. Groups were matched for kilocalories consumed and macronutrient distribution at baseline.
RESULTS


After 12 months of TRE, body mass, fat mass, insulin-like growth factor 1, and testosterone were significantly lower compared with ND. Moreover, inflammatory markers (interleukin 6, interleukin 1β, and tumor necrosis factor α), insulin sensitivity (fasting glucose, insulin, and homeostatic model assessment for insulin resistance index), and lipid profile (cholesterol, HDL, and LDL) significantly improved after TRE compared with ND. Finally, subjects in TRE spontaneously decreased their daily energy intake, whereas those in ND maintained their starting kilocalories per day. No adverse events were reported.
CONCLUSIONS


Our results suggest that long-term TRE combined with a resistance training program is feasible, safe, and effective in reducing inflammatory markers and risk factors related to cardiovascular and metabolic diseases.",2021,"After 12 months of TRE, body mass, fat mass, IGF-1 and testosterone were significantly lower compared to ND.","['Twenty healthy subjects', 'healthy resistance-trained males after 2 months']","['time-restricted eating (TRE) diet or a normal diet (ND) protocol, along with resistance training', 'resistance training program']","['daily energy intake', 'TRE, body mass, fat mass, IGF-1 and testosterone', 'inflammatory markers (IL-6, IL-1β and TNF-α), insulin sensitivity (fasting glucose, insulin and HOMA-IR) and lipid profile (cholesterol, HDL and LDL', 'adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.0111478,"After 12 months of TRE, body mass, fat mass, IGF-1 and testosterone were significantly lower compared to ND.","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Moro', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, Padova, ITALY.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Tinsley', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX.'}, {'ForeName': 'Francesco Q', 'Initials': 'FQ', 'LastName': 'Pacelli', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, Padova, ITALY.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Marcolin', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, Padova, ITALY.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Department of Psychology, Educational Science and Human Movement, University of Palermo, Palermo, ITALY.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Paoli', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, Padova, ITALY.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002738']
1919,34649262,ɑ-Lactalbumin Improves Sleep and Recovery after Simulated Evening Competition in Female Athletes.,"PURPOSE


This study aimed to determine the efficacy of α-lactalbumin (A-LAC) supplementation for improving sleep and performance recovery after simulated evening competition in female athletes.
METHODS


Sixteen trained women (mean ± SD: age, 27 ± 7 yr; mass, 62 ± 10 kg; stature, 167 ± 8 cm) participated in this randomized double-blind three-arm crossover study. Participants completed a simulated evening competition before consuming either an A-LAC whey protein, whey protein placebo (PLA), or water control (CON) beverage. Sleep was monitored via polysomnography, and participants completed a series of physical, cognitive, and perceptual assessments before, and 14 and 24 h after simulated competition.
RESULTS


Non-rapid eye movement stage 2 sleep increased after competition in A-LAC (pre, 199 ± 44 min; post, 212 ± 37 min) but decreased in CON (pre, 228 ± 43 min; post, 195 ± 40 min) and PLA (pre, 224 ± 25 min; post, 211 ± 35 min; P = 0.012). In addition, Yo-Yo Intermittent Recovery Test Level 1 distance improved over time in A-LAC (baseline, 664 ± 332 m; 14 h post, 667 ± 326 m; 24 h post, 781 ± 427 m) compared with CON (baseline, 741 ± 366 m; 14 h post, 648 ± 351 m; 24 h post, 720 ± 407 m) and PLA (baseline, 763 ± 394 m; 14 h post, 636 ± 366 m; 24 h post, 720 ± 396 m; P < 0.001).
CONCLUSIONS


The findings indicate that A-LAC supplementation may be useful for retaining some sleep characteristics after evening competition, leading to improved physical performance in female athletes.",2021,"In addition, Yo-Yo Intermittent Recovery Test Level 1 distance improved over time in A-LAC (baseline 664 ± 332 m; 14 h post 667 ± 326 m; 24 h post 781 ± 427 m) compared to CON (baseline 741 ± 366 m","['Female Athletes', 'female athletes', 'Sixteen trained females (mean ± SD; age 27 ± 7 years; mass 62 ± 10 kg; stature 167 ± 8 cm']","['simulated evening competition before consuming either an A-LAC whey protein, whey protein placebo (PLA) or water control (CON) beverage', 'α-lactalbumin (A-LAC) supplementation']",['Sleep'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517595', 'cui_str': '167'}]","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0022912', 'cui_str': 'Lactalbumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}]",16.0,0.186498,"In addition, Yo-Yo Intermittent Recovery Test Level 1 distance improved over time in A-LAC (baseline 664 ± 332 m; 14 h post 667 ± 326 m; 24 h post 781 ± 427 m) compared to CON (baseline 741 ± 366 m","[{'ForeName': 'Kathleen H', 'Initials': 'KH', 'LastName': 'Miles', 'Affiliation': ''}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Clark', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, AUSTRALIA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Fowler', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, AUSTRALIA.'}, {'ForeName': 'Madeleine J', 'Initials': 'MJ', 'LastName': 'Gratwicke', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, AUSTRALIA.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Welvaert', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, AUSTRALIA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'AIS Operations, Australian Institute of Sport, Bruce, Canberra, AUSTRALIA.'}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Pumpa', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002743']
1920,34648913,"Availability, use, and consumption practices of ready-to-use therapeutic foods prescribed to children with uncomplicated severe acute malnutrition aged 6-59 months during outpatient treatment in Burkina Faso.","Ready-to-use-therapeutic-foods (RUTF) was designed for the nutritional management of children with uncomplicated severe acute malnutrition (SAM) treated as outpatients. However, to our knowledge, no study has evaluated the availability, use and consumption of RUTF within the beneficiary household in programs and in the context of a reduction in the dose of RUTF. This study, assessed the effect of a reduction in RUTF dose on the availability, use, consumption, and perceptions of caregivers on RUTF prescribed to 516 children treated for SAM, aged 6-59 months in Burkina Faso. Children received a weekly dose of RUTF according to their treatment arm until recovery. Data were collected by structured individual in-depth interviews, with caregivers one month and two months post-admission. Differences between children receiving reduced RUTF (intervention arm) and those receiving standard RUTF (control arm) were assessed by Poisson, logistic, and ordered logistic regression model. RUTF was available for the whole week in 95% in intervention arm compared to about 98% in control arm (p > 0.05). Starting from week 3 onwards, children in intervention arm consumed an average of 9 sachets of RUTF per week compared to 15 sachets in control arm (p < 0.001) and 5% of children in intervention arm reported leftover compared to 11% in control arm (p < 0.05). About 40% of children in intervention arm consumed RUTF at least 3-times per day compared to 82% in control arm (p < 0.001). The amount of RUTF prescribed was perceived as sufficient in 93% by caregivers in intervention arm against 97% in control arm (p > 0.05). In conclusion, reducing the dose of RUTF did not affect the availability of RUTF during treatment but did reduce leftover and the frequency of consumption of RUTF.",2021,The amount of RUTF prescribed was perceived as sufficient in 93% by caregivers in intervention arm against 97% in control arm (p > 0.05).,"['children with uncomplicated severe acute malnutrition (SAM) treated as outpatients', '516 children treated for SAM, aged 6-59 months in Burkina Faso', 'children with uncomplicated severe acute malnutrition aged 6-59 months during outpatient treatment in Burkina Faso']","['RUTF', 'Ready-to-use-therapeutic-foods (RUTF']","['frequency of consumption of RUTF', 'availability of RUTF']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",516.0,0.0169199,The amount of RUTF prescribed was perceived as sufficient in 93% by caregivers in intervention arm against 97% in control arm (p > 0.05).,"[{'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Nikièma', 'Affiliation': 'Nutrition and Health Department, Action Contre la Faim, mission in Burkina Faso, France; School of Nutrition and Food Sciences and Technologies, Faculty of Agronomic Sciences, University of Abomey-Calavi, Benin. Electronic address: nikiema.victor@yahoo.fr.'}, {'ForeName': 'Nadia F', 'Initials': 'NF', 'LastName': 'Fogny', 'Affiliation': 'School of Nutrition and Food Sciences and Technologies, Faculty of Agronomic Sciences, University of Abomey-Calavi, Benin.'}, {'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Kangas', 'Affiliation': 'Expertise and Advocacy Department, Action contre la Faim, Paris, France.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lachat', 'Affiliation': 'Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Belgium.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Salpéteur', 'Affiliation': 'Expertise and Advocacy Department, Action contre la Faim, Paris, France.'}]",Appetite,['10.1016/j.appet.2021.105751']
1921,34648868,Theta Band Transcranial Alternating Current Stimulation Enhances Arithmetic Learning: A Systematic Comparison of Different Direct and Alternating Current Stimulations.,"Over the last decades, interest in transcranial electrical stimulation (tES) has grown, as it might allow for causal investigations of the associations between cortical activity and cognition as well as to directly influence cognitive performance. The main objectives of the present work were to assess whether tES can enhance the acquisition and application of arithmetic abilities, and whether it enables a better assessment of underlying neurophysiological processes. To this end, the present, double-blind, sham-controlled study assessed the effects of six active stimulations (three tES protocols: anodal transcranial direct current stimulation (tDCS), alpha band transcranial alternating current stimulation (tACS), and theta band tACS; targeting the left dorsolateral prefrontal cortex or the left posterior parietal cortex) on the acquisition of an arithmetic procedure, arithmetic facts, and event-related synchronization/desynchronization (ERS/ERD) patterns. 137 healthy adults were randomly assigned to one of seven groups, each receiving one of the tES-protocols during learning. Results showed that frontal theta band tACS reduced the repetitions needed to learn novel facts and both, frontal and parietal theta band tACS accelerated the decrease in calculation times in fact learning problems. The beneficial effect of frontal theta band tACS may reflect enhanced executive functions, allowing for better control and inhibition processes and hence, a faster acquisition and integration of novel fact knowledge. However, there were no significant effects of the stimulations on procedural learning or ERS/ERD patterns. Overall, theta band tACS appears promising as a support for arithmetic fact training, but effects on procedural calculations and neurophysiological processes remain ambiguous.",2021,"Results showed that frontal theta band tACS reduced the repetitions needed to learn novel facts and both, frontal and parietal theta band tACS accelerated the decrease in calculation times in fact learning problems.",['137 healthy adults'],"['six active stimulations (three tES protocols: anodal transcranial direct current stimulation (tDCS), alpha band transcranial alternating current stimulation (tACS), and theta band tACS', 'transcranial electrical stimulation (tES', 'frontal theta band tACS', 'Theta band transcranial alternating current stimulation enhances arithmetic learning']",['procedural learning or ERS/ERD patterns'],"[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0455803', 'cui_str': 'Transcranial electrical stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C4304298', 'cui_str': 'Procedural learning'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",137.0,0.0334444,"Results showed that frontal theta band tACS reduced the repetitions needed to learn novel facts and both, frontal and parietal theta band tACS accelerated the decrease in calculation times in fact learning problems.","[{'ForeName': 'Jochen A', 'Initials': 'JA', 'LastName': 'Mosbacher', 'Affiliation': 'Section of Educational Neuroscience, Institute of Psychology, University of Graz, Graz, Austria. Electronic address: Jochen.mosbacher@uni-graz.at.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Halverscheid', 'Affiliation': 'Mathematics Institute, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Kolja', 'Initials': 'K', 'LastName': 'Pustelnik', 'Affiliation': 'Mathematics Institute, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Danner', 'Affiliation': 'Section of Educational Neuroscience, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Prassl', 'Affiliation': 'Section of Educational Neuroscience, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Brunner', 'Affiliation': 'Section of Educational Neuroscience, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Stephan E', 'Initials': 'SE', 'LastName': 'Vogel', 'Affiliation': 'Section of Educational Neuroscience, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany; Department of Neurology, University Medical Hospital Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Roland H', 'Initials': 'RH', 'LastName': 'Grabner', 'Affiliation': 'Section of Educational Neuroscience, Institute of Psychology, University of Graz, Graz, Austria; BioTechMed Graz, Graz, Austria.'}]",Neuroscience,['10.1016/j.neuroscience.2021.10.006']
1922,34648847,Short- and long-term effects of different exercise programs on the gait performance of older adults with subjective cognitive decline: A randomized controlled trial.,"BACKGROUND


Older adults, especially those with cognitive decline, often have poor gait performance, which results in poor clinical outcomes due to falls or decreased daily physical activity. The effects of various exercises on gait performance have been studied, whereas the short-term and long-term effects of different exercise modalities remain unknown.
OBJECTIVE


To compare the short- and long-term effects of aerobic training (AT), resistance training (RT), and combined training (CT) on the gait performance of community-dwelling older adults with subjective cognitive decline (SCD).
DESIGN


A four-arm, randomized controlled trial.
SETTING AND SUBJECTS


388 community-dwelling older adults with SCD (mean age, 72.3 years).
METHODS


Participants attended an exercise or education class twice a week for 26 weeks. 10 gait performance parameters were examined at baseline, post-intervention (Week 26), and after 26 weeks of follow-up (Week 52) using an electronic walkway system.
RESULTS


The mean adherence of exercise sessions was 82.5 to 85.9%. All exercise intervention induced an improvement in gait speed, stride time, cadence, stride length, and double-support time at Week 26 (p < .05), without significant intergroup differences among exercise interventions. However, only RT showed a significant effect on some spatiotemporal gait parameters at Week 52. The analyses for the gait variability parameters showed mild effects of all exercise interventions.
CONCLUSION


All of the exercise programs examined had a positive short-term effect on spatiotemporal gait parameters of older adults with SCD, despite no effect on gait variability parameters. RT are most recommended when long-lasting effects are the primary aim.",2021,"All exercise intervention induced an improvement in gait speed, stride time, cadence, stride length, and double-support time at Week 26 (p < .05), without significant intergroup differences among exercise interventions.","['older adults with SCD', 'Participants attended an exercise or education class twice a week for 26\u202fweeks', 'Older adults', '388 community-dwelling older adults with SCD (mean age, 72.3\u202fyears', 'community-dwelling older adults with subjective cognitive decline (SCD', 'older adults with subjective cognitive decline']","['aerobic training (AT), resistance training (RT), and combined training (CT', 'exercise programs', 'various exercises']","['spatiotemporal gait parameters', 'gait performance', 'mean adherence of exercise sessions', 'gait speed, stride time, cadence, stride length, and double-support time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",388.0,0.0295963,"All exercise intervention induced an improvement in gait speed, stride time, cadence, stride length, and double-support time at Week 26 (p < .05), without significant intergroup differences among exercise interventions.","[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan; Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Umegaki', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan; Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Uemura', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Chiharu', 'Initials': 'C', 'LastName': 'Uno', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Kitada', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Chi Hsien', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan; Department of Family Medicine, E-Da Hospital, Kaohsiung City, Taiwan, ROC.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kuzuya', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan; Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: kuzuya@med.nagoya-u.ac.jp.'}]",Experimental gerontology,['10.1016/j.exger.2021.111590']
1923,34652717,Comparison of Ultrasound-Guided Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block for Postoperative Analgesia in Elderly Patients After Laparoscopic Colorectal Surgery: A Prospective Randomized Study.,"INTRODUCTION


Postoperative analgesia in elderly patients is still a thorny problem. Ultrasound-guided oblique subcostal transverse abdominis plane block (TAPB) has been demonstrated to provide postoperative analgesia after abdominal surgeries. However, recent studies have suggested that an alternative method, erector spinae plane block (ESPB), might also be effective. In this study, we compared the postoperative analgesic effects of ESPB and TAPB in elderly patients who had undergone laparoscopic colorectal surgery.
METHODS


Sixty-two elderly patients (≥ 65 years old) scheduled for elective laparoscopic colorectal surgery with general anesthesia were randomly allocated to two equally sized groups: ESPB group and TAPB group. The ESPB group had a bilateral erector spinae plane block, and the TAPB group had a bilateral oblique subcostal transverse abdominis plane block. The primary outcome was visual analogue scale (VAS) pain score during the first 24 postoperative hours at resting and active states. The secondary outcomes were postoperative consumption of sufentanil, satisfaction score, the number of patients who required antiemetics, incidence of block-related complications, and other side events.
RESULTS


There were no demographic differences between two groups. Compared to the TAPB group, the ESPB group had lower VAS pain scores and sufentanil consumption during the first 24 postoperative hours. Additionally, ESPB reduced the occurrence of postoperative nausea and vomiting. Furthermore, the satisfaction score was higher in the ESPB group. No other complications were reported between the two groups.
CONCLUSIONS


Compared with oblique subcostal TAPB, ESPB more effectively reduced postoperative pain and opioid consumption. Thus, ESPB is suitable for postoperative analgesia in elderly patients who have undergone laparoscopic colorectal surgery.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR2000033236.",2021,"No other complications were reported between the two groups.
","['After Laparoscopic Colorectal Surgery', 'elderly patients', 'elderly patients who have undergone laparoscopic colorectal surgery', 'Elderly Patients', 'elderly patients who had undergone laparoscopic\xa0colorectal\xa0surgery', 'Sixty-two elderly patients (≥', '65\xa0years old) scheduled for elective laparoscopic\xa0colorectal\xa0surgery with general anesthesia']","['TAPB', 'ESPB', 'ESPB group and TAPB', 'Ultrasound-guided oblique subcostal transverse abdominis plane block (TAPB', 'oblique subcostal TAPB, ESPB', 'Ultrasound-Guided Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block', 'ESPB and TAPB']","['occurrence of postoperative nausea and vomiting', 'bilateral oblique subcostal transverse abdominis plane block', 'postoperative pain and opioid consumption', 'satisfaction score', 'pain score', 'postoperative consumption of sufentanil, satisfaction score, the number of patients who required antiemetics, incidence of block-related complications, and other side events', 'visual analogue scale (VAS', 'bilateral erector spinae plane block', 'VAS pain scores and sufentanil consumption']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0442184', 'cui_str': 'Subcostal'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0442184', 'cui_str': 'Subcostal'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",62.0,0.0930829,"No other complications were reported between the two groups.
","[{'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Qi-Hong', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, No. 1882, Zhonghuan South Road, Jiaxing, 314001, Zhejiang, China. shenqihong1989@163.com.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Xu-Yan', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, No. 1882, Zhonghuan South Road, Jiaxing, 314001, Zhejiang, China.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, No. 1882, Zhonghuan South Road, Jiaxing, 314001, Zhejiang, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yan-Jun', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, No. 1882, Zhonghuan South Road, Jiaxing, 314001, Zhejiang, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Ke', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, No. 1882, Zhonghuan South Road, Jiaxing, 314001, Zhejiang, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Rong', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, No. 1882, Zhonghuan South Road, Jiaxing, 314001, Zhejiang, China.'}]",Pain and therapy,['10.1007/s40122-021-00329-x']
1924,34636739,Gamifying Sexual Education for Adolescents in a Low-Tech Setting: Quasi-Experimental Design Study.,"BACKGROUND


Sexual education has become increasingly important as unhealthy sexual practices and subsequent health risks become more prevalent during adolescence. Traditional sex education teaching methodologies are limiting for digital natives exposed to various digital technologies. Harnessing the power of technology applications attractive to the younger generation may be a useful approach for teaching sex education.
OBJECTIVE


The aim of this study was to improve sexual health knowledge and understanding of the problems associated with unhealthy sexual practices and address sexual and reproductive health challenges experienced in a low-tech setting.
METHODS


A participatory design approach was used to develop the digital gamified methodology. A sample of 120 secondary school students aged 11-15 were randomly assigned to either experimental or control group for each of the 3 teaching approaches: (1) gamified instruction (actual serious games [SG] in teaching); (2) gamification (GM; making nongames, such as game-like learning); and (3) traditional teaching (TT) methods.
RESULTS


The SG and GM approaches were more effective than TT methods in teaching sexual health education. Specifically, the average scores across groups demonstrated an increase of mean scores from the pre- to posttest (25.10 [SD 5.50] versus 75.86 [SD 13.16]; t 119 =41.252; P<.001 [2 tailed]). Analysis of variance indicated no significant differences across groups for pretest scores (F 2,117 =1.048, P=.35). Significant differences across groups were evident in the posttest scores. Students in the SG and GM groups had higher average scores than the TT group (F 2,117 =83.98; P<.001). Students reported increased learning motivation, attitude, know-how, and participation in learning (P<.001) when using SG and GM approaches.
CONCLUSIONS


Digital health technologies (particularly teaching and learning through gamified instruction and other novel approaches) may improve sexual health education. These findings may also be applied by practitioners in health care settings and by researchers wishing to further the development of sex education.",2021,"Students reported increased learning motivation, attitude, know-how, and participation in learning (P<.001) when using SG and GM approaches.
",['120 secondary school students aged 11-15'],"['Gamifying Sexual Education', 'gamified instruction (actual serious games [SG] in teaching); (2) gamification (GM; making nongames, such as game-like learning); and (3) traditional teaching (TT) methods']","['sexual health knowledge', 'learning motivation, attitude, know-how, and participation in learning', 'mean scores', 'average scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0412831,"Students reported increased learning motivation, attitude, know-how, and participation in learning (P<.001) when using SG and GM approaches.
","[{'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Haruna', 'Affiliation': 'Writing Lab, Institute for the Future of Education, Tecnologico de Monterrey, Monterrey, Mexico.'}, {'ForeName': 'Kingsley', 'Initials': 'K', 'LastName': 'Okoye', 'Affiliation': 'Writing Lab, Institute for the Future of Education, Tecnologico de Monterrey, Monterrey, Mexico.'}, {'ForeName': 'Zamzami', 'Initials': 'Z', 'LastName': 'Zainuddin', 'Affiliation': 'Faculty of Education, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Faculty of Education, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Chu', 'Affiliation': 'Faculty of Education, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Hosseini', 'Affiliation': 'Writing Lab, Institute for the Future of Education, Tecnologico de Monterrey, Monterrey, Mexico.'}]",JMIR serious games,['10.2196/19614']
1925,34636738,Immersion Experiences in a Tablet-Based Markerless Augmented Reality Working Memory Game: Randomized Controlled Trial and User Experience Study.,"BACKGROUND


In recent years, augmented reality (AR), especially markerless augmented reality (MAR), has been used more prevalently to create training games in an attempt to improve humans' cognitive functions. This has been driven by studies claiming that MAR provides users with more immersive experiences that are situated in the real world. Currently, no studies have scientifically investigated the immersion experience of users in a MAR cognitive training game. Moreover, there is an observed lack of instruments on measuring immersion in MAR cognitive training games.
OBJECTIVE


This study, using two existing immersion questionnaires, investigates students' immersion experiences in a novel MAR n-back game.
METHODS


The n-back task is a continuous performance task that taps working memory (WM) capacity. We compared two versions of n-back training. One was presented in a traditional 2D format, while the second version used MAR. There were 2 experiments conducted in this study that coordinated with 2 types of immersion questionnaires: the modified Immersive Experiences Questionnaire (IEQ) and the Augmented Reality Immersion (ARI) questionnaire. Two groups of students from two universities in China joined the study, with 60 participants for the first experiment (a randomized controlled experiment) and 51 participants for the second.
RESULTS


Both groups of students experienced immersion in the MAR n-back game. However, the MAR n-back training group did not experience stronger immersion than the traditional (2D) n-back control group in the first experiment. The results of the second experiment showed that males felt deeply involved with the AR environment, which resulted in obtaining higher levels of immersion than females in the MAR n-back game.
CONCLUSIONS


Both groups of students experienced immersion in the MAR n-back game. Moreover, both the modified IEQ and ARI have the potential to be used as instruments to measure immersion in MAR game settings.
TRIAL REGISTRATION


UMIN Clinical Trials Registry UMIN000045314; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051725.",2021,"The results of the second experiment showed that males felt deeply involved with the AR environment, which resulted in obtaining higher levels of immersion than females in the MAR n-back game.
","['Two groups of students from two universities in China joined the study, with 60 participants for the first experiment (a randomized controlled experiment) and 51 participants for the second', ""students' immersion experiences in a novel MAR n-back game"", 'Immersion Experiences in a Tablet-Based Markerless Augmented Reality Working Memory Game']",['modified Immersive Experiences Questionnaire (IEQ) and the Augmented Reality Immersion (ARI) questionnaire'],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]",[],60.0,0.0350988,"The results of the second experiment showed that males felt deeply involved with the AR environment, which resulted in obtaining higher levels of immersion than females in the MAR n-back game.
","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Education Information Technology, Faculty of Education, East China Normal University, Shanghai, China.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Robb', 'Affiliation': 'Research Faculty of Media and Communication, Hokkaido University, Sapporo, Japan.'}]",JMIR serious games,['10.2196/27036']
1926,34635855,"ACC inhibitor alone or co-administered with a DGAT2 inhibitor in patients with non-alcoholic fatty liver disease: two parallel, placebo-controlled, randomized phase 2a trials.","Alterations in lipid metabolism might contribute to the pathogenesis of non-alcoholic fatty liver disease (NAFLD). However, no pharmacological agents are currently approved in the United States or the European Union for the treatment of NAFLD. Two parallel phase 2a studies investigated the effects of liver-directed ACC1/2 inhibition in adults with NAFLD. The first study ( NCT03248882 ) examined the effects of monotherapy with a novel ACC1/2 inhibitor, PF-05221304 (2, 10, 25 and 50 mg once daily (QD)), versus placebo at 16 weeks of treatment; the second study ( NCT03776175 ) investigated the effects of PF-05221304 (15 mg twice daily (BID)) co-administered with a DGAT2 inhibitor, PF-06865571 (300 mg BID), versus placebo after 6 weeks of treatment. The primary endpoint in both studies was percent change from baseline in liver fat assessed by magnetic resonance imaging-proton density fat fraction. Dose-dependent reductions in liver fat reached 50-65% with PF-05221304 monotherapy doses ≥10 mg QD; least squares mean (LSM) 80% confidence interval (CI) was -7.2 (-13.9, 0.0), -17.1 (-22.7, -11.1), -49.9 (-53.3, -46.2), -55.9 (-59.0, -52.4) and -64.8 (-67.5, -62.0) with 16 weeks placebo and PF-05221304 2, 10, 25 and 50 mg QD, respectively. The overall incidence of adverse events (AEs) did not increase with increasing PF-05221304 dose, except for a dose-dependent elevation in serum triglycerides (a known consequence of hepatic acetyl-coenzyme A carboxylase (ACC) inhibition) in 23/305 (8%) patients, leading to withdrawal in 13/305 (4%), and a dose-dependent elevation in other serum lipids. Co-administration of PF-05221304 and PF-06865571 lowered liver fat compared to placebo (placebo-adjusted LSM (90% CI) -44.6% (-54.8, -32.2)). Placebo-adjusted LSM (90% CI) reduction in liver fat was -44.5% (-55.0, -31.7) and -35.4% (-47.4, -20.7) after 6 weeks with PF-05221304 or PF-06865571 alone. AEs were reported for 10/28 (36%) patients after co-administered PF-05221304 and PF-06865571, with no discontinuations due to AEs, and the ACC inhibitor-mediated effect on serum triglycerides was mitigated, suggesting that PF-05221304 and PF-06865571 co-administration has the potential to address some of the limitations of ACC inhibition alone.",2021,Dose-dependent reductions in liver fat reached 50-65% with PF-05221304 monotherapy doses ≥10 mg QD; least squares mean (LSM) 80% confidence interval (CI) was -7.2,"['patients with non-alcoholic fatty liver disease', 'adults with NAFLD']","['PF-05221304 (15\u2009mg twice daily (BID)) co-administered with a DGAT2 inhibitor, PF-06865571', 'Placebo', 'PF-05221304 and PF-06865571', 'ACC inhibitor alone or co-administered with a DGAT2 inhibitor', 'monotherapy with a novel ACC1/2 inhibitor, PF-05221304', 'placebo (placebo-adjusted LSM (90% CI', 'Co', 'placebo']","['hepatic acetyl-coenzyme A carboxylase (ACC) inhibition', 'liver fat', 'overall incidence of adverse events (AEs', 'liver fat assessed by magnetic resonance imaging-proton density fat fraction', 'serum triglycerides']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0001022', 'cui_str': 'Acetyl-CoA carboxylase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}]",,0.40754,Dose-dependent reductions in liver fat reached 50-65% with PF-05221304 monotherapy doses ≥10 mg QD; least squares mean (LSM) 80% confidence interval (CI) was -7.2,"[{'ForeName': 'Roberto A', 'Initials': 'RA', 'LastName': 'Calle', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Neeta B', 'Initials': 'NB', 'LastName': 'Amin', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Carvajal-Gonzalez', 'Affiliation': 'Early Clinical Development, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Trenton T', 'Initials': 'TT', 'LastName': 'Ross', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Bergman', 'Affiliation': 'Early Clinical Development, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Sudeepta', 'Initials': 'S', 'LastName': 'Aggarwal', 'Affiliation': 'Early Clinical Development, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Collin', 'Initials': 'C', 'LastName': 'Crowley', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rinaldi', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mancuso', 'Affiliation': 'Early Clinical Development, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Aggarwal', 'Affiliation': 'Aggarwal and Associates Limited, Brampton, ON, Canada.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Somayaji', 'Affiliation': 'Early Clinical Development, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Inglot', 'Affiliation': 'Department of Infectious Diseases, Liver Diseases and Acquired Immune Deficiencies, Wrocław Medical University, Wrocław, Poland.'}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Tuthill', 'Affiliation': 'Early Clinical Development, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Kou', 'Initials': 'K', 'LastName': 'Kou', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Boucher', 'Affiliation': 'Drug Safety Research and Development Global Pathology, Pfizer Worldwide Research and Development, Cambridge, MA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Tesz', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dullea', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Kendra K', 'Initials': 'KK', 'LastName': 'Bence', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Albert M', 'Initials': 'AM', 'LastName': 'Kim', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Pfefferkorn', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Esler', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA. william.esler@Pfizer.com.'}]",Nature medicine,['10.1038/s41591-021-01489-1']
1927,34647896,A Novel Mobile Health App to Educate and Empower Young People With Type 1 Diabetes to Exercise Safely: Prospective Single-Arm Mixed Methods Pilot Study.,"BACKGROUND


Empowering young people with type 1 diabetes (T1D) to manage their blood glucose levels during exercise is a complex challenge faced by health care professionals due to the unpredictable nature of exercise and its effect on blood glucose levels. Mobile health (mHealth) apps would be useful as a decision-support aid to effectively contextualize a blood glucose result and take appropriate action to optimize glucose levels during and after exercise. A novel mHealth app acT1ve was recently developed, based on expert consensus exercise guidelines, to provide real-time support for young people with T1D during exercise.
OBJECTIVE


Our aim was to pilot acT1ve in a free-living setting to assess its acceptability and functionality, and gather feedback on the user experience before testing it in a larger clinical trial.
METHODS


A prospective single-arm mixed method design was used. Ten participants with T1D (mean age 17.7 years, SD 4.2 years; mean HbA 1c , 54 mmol/mol, SD 5.5 mmol/mol [7.1%, SD 0.5%]) had acT1ve installed on their phones, and were asked to use the app to guide their exercise management for 6 weeks. At the end of 6 weeks, participants completed both a semistructured interview and the user Mobile Application Rating Scale (uMARS). All semistructured interviews were transcribed. Thematic analysis was conducted whereby interview transcripts were independently analyzed by 2 researchers to uncover important and relevant themes. The uMARS was scored for 4 quality subscales (engagement, functionality, esthetics, and information), and a total quality score was obtained from the weighted average of the 4 subscales. Scores for the 4 objective subscales were determined by the mean score of each of its individual questions. The perceived impact and subjective quality of acT1ve for each participant were calculated by averaging the scores of their related questions, but were not considered in the total quality score. All scores have a maximal possible value of 5, and they are presented as medians, IQRs, and ranges.
RESULTS


The main themes arising from the interview analysis were ""increased knowledge,"" ""increased confidence to exercise,"" and ""suitability"" for people who were less engaged in exercise. The uMARS scores for acT1ve were high (out of 5) for its total quality (median 4.3, IQR 4.2-4.6), engagement (median 3.9, IQR 3.6-4.2), functionality (median 4.8, IQR 4.5-4.8), information (median 4.6, IQR 4.5-4.8), esthetics (median 4.3, IQR 4.0-4.7), subjective quality (median 4.0, IQR 3.8-4.2), and perceived impact (median 4.3, IQR 3.6-4.5).
CONCLUSIONS


The acT1ve app is functional and acceptable, with a high user satisfaction. The efficacy and safety of this app will be tested in a randomized controlled trial in the next phase of this study.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001414101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378373.",2021,"The uMARS scores for acT1ve were high (out of 5) for its total quality (median 4.3, IQR 4.2-4.6), engagement (median 3.9, IQR 3.6-4.2), functionality (median 4.8, IQR 4.5-4.8), information (median 4.6, IQR 4.5-4.8), esthetics (median 4.3, IQR 4.0-4.7), subjective quality (median 4.0, IQR 3.8-4.2), and perceived impact (median 4.3, IQR 3.6-4.5).
","['Empowering young people with type 1 diabetes (T1D', 'Ten participants with T1D (mean age 17.7 years, SD 4.2 years; mean HbA 1c , 54 mmol/mol, SD 5.5 mmol/mol [7.1%, SD 0.5%]) had acT1ve installed on their phones', 'Young People With Type 1 Diabetes', 'young people with T1D during exercise']",['Exercise Safely'],"['quality subscales (engagement, functionality, esthetics, and information), and a total quality score', 'functionality', 'total quality', 'subjective quality', 'knowledge,"" ""increased confidence to exercise,"" and ""suitability', 'uMARS scores for acT1ve', 'esthetics', 'blood glucose levels', 'efficacy and safety', 'total quality score', 'Mobile Application Rating Scale (uMARS']","[{'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",10.0,0.046052,"The uMARS scores for acT1ve were high (out of 5) for its total quality (median 4.3, IQR 4.2-4.6), engagement (median 3.9, IQR 3.6-4.2), functionality (median 4.8, IQR 4.5-4.8), information (median 4.6, IQR 4.5-4.8), esthetics (median 4.3, IQR 4.0-4.7), subjective quality (median 4.0, IQR 3.8-4.2), and perceived impact (median 4.3, IQR 3.6-4.5).
","[{'ForeName': 'Vinutha B', 'Initials': 'VB', 'LastName': 'Shetty', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Australia.""}, {'ForeName': 'Wayne H K', 'Initials': 'WHK', 'LastName': 'Soon', 'Affiliation': ""Telethon Kids Institute, Children's Diabetes Centre, The University of Western Australia, Perth, Australia.""}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Roberts', 'Affiliation': ""Telethon Kids Institute, Children's Diabetes Centre, The University of Western Australia, Perth, Australia.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Fried', 'Affiliation': ""Telethon Kids Institute, Children's Diabetes Centre, The University of Western Australia, Perth, Australia.""}, {'ForeName': 'Heather C', 'Initials': 'HC', 'LastName': 'Roby', 'Affiliation': ""Telethon Kids Institute, Children's Diabetes Centre, The University of Western Australia, Perth, Australia.""}, {'ForeName': 'Grant J', 'Initials': 'GJ', 'LastName': 'Smith', 'Affiliation': ""Telethon Kids Institute, Children's Diabetes Centre, The University of Western Australia, Perth, Australia.""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Fournier', 'Affiliation': ""Telethon Kids Institute, Children's Diabetes Centre, The University of Western Australia, Perth, Australia.""}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Australia.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Davis', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Australia.""}]",JMIR diabetes,['10.2196/29739']
1928,34647893,"Acceptability, Engagement, and Effects of a Mobile Digital Intervention to Support Mental Health for Young Adults Transitioning to College: Pilot Randomized Controlled Trial.","BACKGROUND


The transition from high school to college can exacerbate mental health problems in young adults yet barriers prevent seamless mental health care. Existing digital support tools show promise but are not yet designed to optimize engagement or implementation.
OBJECTIVE


The goal of the research was to test acceptability and effects of an automated digital Mobile Support Tool for Mental Health (MoST-MH) for young adults transitioning to college.
METHODS


Youths aged 18 years and older with a current mental health diagnosis preparing to transition to college (n=52; 85% female [45/52], 91% White [48/52]) were recruited from a primary care (n=31) and a mental health clinic (n=21). Participants were randomized 2:1 to either receive MoST-MH (n=34) or enhanced Usual Care (eUC; n=18). MoST-MH included periodic text message and web-based check-ins of emotional health, stressors, negative impacts, and self-efficacy that informed tailored self-care support messages. Both eUC and MoST-MH participants received links to a library of psychoeducational videos and were asked to complete web-based versions of the Mental Health Self-Efficacy Scale (MHSES), College Counseling Center Assessment of Psychological Symptoms (CCAPS), and Client Service Receipt Inventory for Mental Health (C-SRI) monthly for 3 months and the Post-Study System Usability Scale (PSSUQ) at 3-months.
RESULTS


MoST-MH participants were sent a median of 5 (range 3 to 10) text message check-in prompts over the 3-month study period and 100% were completed; participants were sent a median of 2 (range 1 to 8) web-based check-in prompts among which 78% (43/55) were completed. PSSUQ scores indicate high usability (mean score 2.0). Results from the completer analysis demonstrated reductions in mental health symptoms over time and significant between-group effects of MoST-MH compared to eUC on depressive symptom severity (d=0.36, 95% CI 0.08 to 0.64). No significant differences in mental health self-efficacy or mental health health care use were observed.
CONCLUSIONS


In this pilot trial, we found preliminary evidence that MoST-MH was engaged with at high rates and found to be highly usable and reduced depression symptoms relative to eUC among youth with mental health disorders transitioning to college. Findings were measured during the COVID-19 pandemic, and the study was not powered to detect differences in outcomes between groups; therefore, further testing is needed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04560075; https://clinicaltrials.gov/ct2/show/NCT04560075.",2021,"No significant differences in mental health self-efficacy or mental health health care use were observed.
","['Young Adults Transitioning to College', 'youth with mental health disorders transitioning to college', 'young adults transitioning to college', 'Youths aged 18 years and older with a current mental health diagnosis preparing to transition to college (n=52; 85% female [45/52], 91% White [48/52]) were recruited from a primary care (n=31) and a mental health clinic (n=21']","['MoST-MH (n=34) or enhanced Usual Care (eUC', 'Mobile Digital Intervention', 'automated digital Mobile Support Tool for Mental Health (MoST-MH']","['mental health self-efficacy or mental health health care use', 'mental health symptoms', 'depressive symptom severity', 'Post-Study System Usability Scale (PSSUQ', 'Mental Health Self-Efficacy Scale (MHSES), College Counseling Center Assessment of Psychological Symptoms (CCAPS), and Client Service Receipt Inventory for Mental Health', 'periodic text message and web-based check-ins of emotional health, stressors, negative impacts, and self-efficacy']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.107582,"No significant differences in mental health self-efficacy or mental health health care use were observed.
","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Gotkiewicz', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Gotkiewicz', 'Affiliation': 'University of Delaware, Newark, DE, United States.'}, {'ForeName': 'Brandie', 'Initials': 'B', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brent', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, United States.'}]",JMIR formative research,['10.2196/32271']
1929,34637892,Immediately loaded single-implant mandibular overdentures compared to conventional complete dentures: A cost-effectiveness analysis.,"BACKGROUND


In recent years, the single-implant mandibular overdenture (SIMO) has been proposed as an alternative to more complex overdenture designs as a simplified implant intervention for edentulous patients.
OBJECTIVE


The aim of this study was to run a cost-effectiveness analysis alongside a randomized clinical trial comparing the SIMO and the conventional complete denture (CCD) treatment. Imediately loaded external hexagon implant and ball attachment were used for the overdenture goup. Direct costs related to therapies were identified and valuated throughout a 1-year period after delivery, in Brazilian currency (R$) and converted into international dollars (I$) using purchase power parity exchange rates. Treatment effectiveness was measured using the OHIP-Edent and satisfaction scores for calculation of incremental cost-effectiveness ratios (ICER).
RESULTS


Outcomes were assessed at the 1-year follow-up for 65 patients (CCD=34; SIMO=31). Overall OHIP-Edent and satisfaction scores improved significantly in the SIMO group, while remained unchanged in the CCD group. The mean overall costs were R$1,179.04 (I$590.99) for the CCD group and R$2,127.91 (I$1,068.20) for the SIMO group - 80.7% incremental cost for SIMO. The ICER calculation for SIMO treatment showed a mean cost of I$48.20 for 1-point reduction in OHIP-Edent scores, and I$12.56 for 1-point increase in satisfaction score.
CONCLUSIONS


Findings support the effectiveness of this simplified and low-cost implant intervention for edentulous patients. SIMO also seems a cost-effective alternative to the CCD and the relatively low incremental cost may potentially increase the utilization of dental implants among older subjects, especially those with limited financial resources.
CLINICAL SIGNIFICANCE


The immediately loaded single-implant mandibular overdenture was superior to the conventional complete denture in terms of patient-reported outcome measures at a low incremental cost.",2021,The immediately loaded single-implant mandibular overdenture was superior to the conventional complete denture in terms of patient-reported outcome measures at a low incremental cost.,"['edentulous patients', 'older subjects']",['conventional complete denture (CCD) treatment'],"['OHIP-Edent and satisfaction scores for calculation of incremental cost-effectiveness ratios (ICER', 'satisfaction score', 'mean overall costs', 'Overall OHIP-Edent and satisfaction scores']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0433636,The immediately loaded single-implant mandibular overdenture was superior to the conventional complete denture in terms of patient-reported outcome measures at a low incremental cost.,"[{'ForeName': 'Túlio Eduardo', 'Initials': 'TE', 'LastName': 'Nogueira', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Jesio Rodrigues', 'Initials': 'JR', 'LastName': 'Silva', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Lays Noleto', 'Initials': 'LN', 'LastName': 'Nascimento', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Joyce Borges', 'Initials': 'JB', 'LastName': 'Cardoso', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Srinivasan', 'Affiliation': 'Clinic of General, Special Care, and Geriatric Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McKenna', 'Affiliation': ""Centre for Public Health, Queen's University, School of Medicine Dentistry & Biomedical Sciences, Institute of Clinical Science, Belfast, United Kingdom.""}, {'ForeName': 'Cláudio Rodrigues', 'Initials': 'CR', 'LastName': 'Leles', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiânia, Goiás, Brazil. Electronic address: claudio_leles@ufg.br.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103846']
1930,34644619,Effects of exercise on symptoms of anxiety in primary care patients: A randomized controlled trial.,"BACKGROUND


There is a need for high-quality research regarding exercise interventions for persons with anxiety disorders. We investigate whether a 12-week exercise intervention, with different intensities, could reduce anxiety symptoms in patients with anxiety disorders.
METHODS


286 patients were recruited from primary care in Sweden. Severity of symptoms was self-assessed using the Beck Anxiety Inventory (BAI) and the Montgomery Åsberg Depression Rating Scale (MADRS-S). Participants were randomly assigned to one of two group exercise programs with cardiorespiratory and resistance training and one control/standard treatment non-exercise group, with 1:1:1 allocation.
RESULTS


Patients in both exercise groups showed larger improvements in both anxiety and depressive symptoms compared to the control group. No differences in effect sizes were found between the two groups. To study a clinically relevant improvement, BAI and MADRS-S were dichotomized with the mean change in the control group as reference. In adjusted models the odds ratio for improved symptoms of anxiety after low-intensity training was 3.62 (CI 1.34-9.76) and after moderate/high intensity 4.88 (CI 1.66-14.39), for depressive symptoms 4.96 (CI 1.81-13.6) and 4.36 (CI 1.57-12.08) respectively. There was a significant intensity trend for improvement in anxiety symptoms.
LIMITATIONS


The use of self-rating measures which bears the risk of an under- or overestimation of symptoms.
CONCLUSIONS


A 12-week group exercise program proved effective for patients with anxiety syndromes in primary care. These findings strengthen the view of physical exercise as an effective treatment and could be more frequently made available in clinical practice for persons with anxiety issues.",2021,"In adjusted models the odds ratio for improved symptoms of anxiety after low-intensity training was 3.62 (CI 1.34-9.76) and after moderate/high intensity 4.88 (CI 1.66-14.39), for depressive symptoms 4.96 (CI 1.81-13.6) and 4.36 (CI 1.57-12.08) respectively.","['286 patients were recruited from primary care in Sweden', 'primary care patients', 'patients with anxiety syndromes in primary care', 'persons with anxiety disorders', 'patients with anxiety disorders']","['exercise intervention', 'exercise', 'exercise program', 'exercise programs with cardiorespiratory and resistance training and one control/standard treatment non-exercise group, with 1:1:1 allocation']","['Beck Anxiety Inventory (BAI) and the Montgomery Åsberg Depression Rating Scale (MADRS-S', 'symptoms of anxiety', 'BAI and MADRS-S', 'depressive symptoms', 'anxiety symptoms', 'anxiety and depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",286.0,0.00944433,"In adjusted models the odds ratio for improved symptoms of anxiety after low-intensity training was 3.62 (CI 1.34-9.76) and after moderate/high intensity 4.88 (CI 1.66-14.39), for depressive symptoms 4.96 (CI 1.81-13.6) and 4.36 (CI 1.57-12.08) respectively.","[{'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Henriksson', 'Affiliation': 'School of Public Health and Community Medicine/Primary Health Care, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden; Region Västra Götaland, Närhälsan, Gothenburg, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wall', 'Affiliation': 'Department of Internal Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Acute Medicine and Geriatrics, Gothenburg, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Nyberg', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Neurology Clinic, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Adiels', 'Affiliation': 'Biostatistics, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lundin', 'Affiliation': 'Region Västra Götaland, Regionhälsan, Gothenburg, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Bergh', 'Affiliation': 'Region Västra Götaland, Närhälsan, Gothenburg, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Eggertsen', 'Affiliation': 'School of Public Health and Community Medicine/Primary Health Care, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden; R&D Centre Gothenburg and Södra Bohuslän, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Danielsson', 'Affiliation': 'Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden; Region Västra Götaland, Angered Hospital, Gothenburg, Sweden.'}, {'ForeName': 'H Georg', 'Initials': 'HG', 'LastName': 'Kuhn', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden; Institute for Public Health, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Westerlund', 'Affiliation': 'Region Västra Götaland, Regionhälsan, Gothenburg, Sweden.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'David Åberg', 'Affiliation': 'Department of Internal Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Acute Medicine and Geriatrics, Gothenburg, Sweden.'}, {'ForeName': 'Margda', 'Initials': 'M', 'LastName': 'Waern', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Psychosis Clinic, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Åberg', 'Affiliation': 'School of Public Health and Community Medicine/Primary Health Care, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden; Region Västra Götaland, Regionhälsan, Gothenburg, Sweden. Electronic address: maria.aberg@gu.se.'}]",Journal of affective disorders,['10.1016/j.jad.2021.10.006']
1931,34644471,Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder.,"BACKGROUND


Experimental studies and small clinical trials have suggested that treatment with intranasal oxytocin may reduce social impairment in persons with autism spectrum disorder. Oxytocin has been administered in clinical practice to many children with autism spectrum disorder.
METHODS


We conducted a 24-week, placebo-controlled phase 2 trial of intranasal oxytocin therapy in children and adolescents 3 to 17 years of age with autism spectrum disorder. Participants were randomly assigned in a 1:1 ratio, with stratification according to age and verbal fluency, to receive oxytocin or placebo, administered intranasally, with a total target dose of 48 international units daily. The primary outcome was the least-squares mean change from baseline on the Aberrant Behavior Checklist modified Social Withdrawal subscale (ABC-mSW), which includes 13 items (scores range from 0 to 39, with higher scores indicating less social interaction). Secondary outcomes included two additional measures of social function and an abbreviated measure of IQ.
RESULTS


Of the 355 children and adolescents who underwent screening, 290 were enrolled. A total of 146 participants were assigned to the oxytocin group and 144 to the placebo group; 139 and 138 participants, respectively, completed both the baseline and at least one postbaseline ABC-mSW assessments and were included in the modified intention-to-treat analyses. The least-squares mean change from baseline in the ABC-mSW score (primary outcome) was -3.7 in the oxytocin group and -3.5 in the placebo group (least-squares mean difference, -0.2; 95% confidence interval, -1.5 to 1.0; P = 0.61). Secondary outcomes generally did not differ between the trial groups. The incidence and severity of adverse events were similar in the two groups.
CONCLUSIONS


This placebo-controlled trial of intranasal oxytocin therapy in children and adolescents with autism spectrum disorder showed no significant between-group differences in the least-squares mean change from baseline on measures of social or cognitive functioning over a period of 24 weeks. (Funded by the National Institute of Child Health and Human Development; SOARS-B ClinicalTrials.gov number, NCT01944046.).",2021,This placebo-controlled trial of intranasal oxytocin therapy in children and adolescents with autism spectrum disorder showed no significant between-group differences in the least-squares mean change from baseline on measures of social or cognitive functioning over a period of 24 weeks.,"['group; 139 and 138 participants', 'children with autism spectrum disorder', 'Children and Adolescents with Autism Spectrum Disorder', 'children and adolescents with autism spectrum disorder', '355 children and adolescents who underwent screening, 290 were enrolled', 'persons with autism spectrum disorder', 'children and adolescents 3 to 17 years of age with autism spectrum disorder', 'A total of 146 participants']","['intranasal oxytocin therapy', 'oxytocin or placebo', 'intranasal oxytocin', 'oxytocin', 'Intranasal Oxytocin', 'placebo', 'Oxytocin']","['social or cognitive functioning', 'incidence and severity of adverse events', 'least-squares mean change from baseline on the Aberrant Behavior Checklist modified Social Withdrawal subscale (ABC-mSW', 'social function and an abbreviated measure of IQ', 'social impairment']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0424095', 'cui_str': 'Social withdrawal'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",146.0,0.885002,This placebo-controlled trial of intranasal oxytocin therapy in children and adolescents with autism spectrum disorder showed no significant between-group differences in the least-squares mean change from baseline on measures of social or cognitive functioning over a period of 24 weeks.,"[{'ForeName': 'Linmarie', 'Initials': 'L', 'LastName': 'Sikich', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'King', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDougle', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Sanders', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Spanos', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Chandrasekhar', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'M D Pilar', 'Initials': 'MDP', 'LastName': 'Trelles', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Rockhill', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Palumbo', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Witters Cundiff', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Siper', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Mendy', 'Initials': 'M', 'LastName': 'Minjarez', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Nowinski', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marler', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Shuffrey', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Alderman', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Weissman', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Zappone', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Mullett', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Crosson', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Hong', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Siecinski', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Giamberardino', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Lilin', 'Initials': 'L', 'LastName': 'She', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Manjushri', 'Initials': 'M', 'LastName': 'Bhapkar', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Dean', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Scheer', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Gregory', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Veenstra-VanderWeele', 'Affiliation': ""From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).""}]",The New England journal of medicine,['10.1056/NEJMoa2103583']
1932,34653953,Effect of hypochlorous acid nasal spray as an adjuvant therapy after functional endoscopic sinus surgery.,"OBJECTIVES


To evaluate the efficacy of hypochlorous acid (HOCl) nasal spray as an adjuvant therapy after functional endoscopic sinus surgery (FESS).
MATERIAL AND METHODS


Patients with chronic rhinosinusitis who had received FESS for treatment were recruited and assigned to one of two groups at random at one month post-surgery. In the HOCl group, patients received 0.02% HOCl nasal spray three times a day for two months. In the control group, normal saline (NS) nasal irrigation was given. Before FESS and before and after nasal spray or irrigation, patients completed the Taiwanese version of the 22-item Sino-Nasal Outcome Test (TWSNOT-22). In addition, patients received endoscopic examination, acoustic rhinometry, smell test, saccharine transit test, and bacterial cultures obtained from their middle meatus.
RESULTS


Seventy-eight patients completed the study. Among them, 41 received HOCl nasal spray, and 37 received NS irrigation. Endoscopic score significantly decreased after 2-month HOCl nasal spray (p = 0.036). TWSNOT-22 score also decreased, although insignificantly (p = 0.285). In contrast, TWSNOT-22 score significantly decreased after NS nasal irrigation (p = 0.017), but endoscopic score did not significantly decrease (p = 0.142).
CONCLUSIONS


Our results showed that HOCl nasal spray had a similar effect to that of NS nasal irrigation in post-FESS care. It can be an alternative of NS nasal irrigation for its convenient application.",2021,"In contrast, TWSNOT-22 score significantly decreased after NS nasal irrigation (p = 0.017), but endoscopic score did not significantly decrease (p = 0.142).
","['functional endoscopic sinus surgery', 'Seventy-eight patients completed the study', 'Patients with chronic rhinosinusitis who had received FESS for treatment', 'functional endoscopic sinus surgery (FESS']","['NS irrigation', 'endoscopic examination, acoustic rhinometry, smell test, saccharine transit test, and bacterial cultures obtained from their middle meatus', 'HOCl nasal spray', 'hypochlorous acid (HOCl) nasal spray', 'normal saline (NS) nasal irrigation', 'hypochlorous acid nasal spray']","['endoscopic score', 'Endoscopic score']","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0430619', 'cui_str': 'Acoustic rhinometry'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0430402', 'cui_str': 'Bacterial culture'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0020600', 'cui_str': 'Hypochlorous acid'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",78.0,0.0155465,"In contrast, TWSNOT-22 score significantly decreased after NS nasal irrigation (p = 0.017), but endoscopic score did not significantly decrease (p = 0.142).
","[{'ForeName': 'Rong-San', 'Initials': 'RS', 'LastName': 'Jiang', 'Affiliation': 'Department of Medical Research, Taichung Veterans General Hospital, 1650, Sec. 4, Taiwan Boulevard, Taichung 40705, Taiwan; Department of Otolaryngology, Taichung Veterans General Hospital, 1650, Sec. 4, Taiwan Boulevard, Taichung 40705, Taiwan; School of Medicine, Chung Shan Medical University, 110, Sec.1, Jianguo N.Rd., Taichung 40201, Taiwan; Rong Hsing Research Center For Translational Medicine, National Chung Hsing University, 145 Xingda Rd., Taichung 402, Taiwan. Electronic address: rsjiang@vghtc.gov.tw.'}, {'ForeName': 'Kai-Li', 'Initials': 'KL', 'LastName': 'Liang', 'Affiliation': 'Department of Otolaryngology, Taichung Veterans General Hospital, 1650, Sec. 4, Taiwan Boulevard, Taichung 40705, Taiwan; School of Medicine, Chung Shan Medical University, 110, Sec.1, Jianguo N.Rd., Taichung 40201, Taiwan; Faculty of Medicine, National Yang Ming Chiao Tung University, 155, Sec.2, Linong Street, Taipei 112, Taiwan. Electronic address: kellyliang1107@gmail.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.103264']
1933,34653732,"Nanocurcumin supplementation ameliorates Behcet's disease by modulating regulatory T cells: A randomized, double-blind, placebo-controlled trial.","Current research was designed to assess the effects of nanocurcumin supplementation on regulatory T (Treg) cells frequency and function in Behçet's disease (BD). In this randomized double-masked, placebo-controlled trial, 36 BD subjects were randomly put into two groups to take one 80 mg nanocurcumin capsule or placebo daily for 8 weeks. Before and after trial, disease activity, Treg cells frequency and expression of related immunologic parameters including forkhead box protein P3 (Foxp3) transcription factor messenger RNA (mRNA) and microRNAs (miRNAs) such as miRNA-25 and miRNA-106b as well as cytokines including transforming growth factor (TGF)-β and interleukin (IL)-10 were studied. Thirty-two patients (17 in the nanocurcumin and 15 in the placebo groups) completed the trial. Treg cells frequency increased significantly in the nanocurcumin group compared with baseline (P < 0.001) and placebo group (P < 0.001). Moreover, FoxP3, TGF-β, IL-10, miRNA-25, and miRNA-106b mRNA expression levels increased considerably in the nanocurcumin group compared to baseline (P < 0.001) and placebo group (P < 0.001, P < 0.001, P = 0.025, P = 0.011, and P < 0.001, respectively). Significant increases in serum TGF-β and IL-10 were seen in nanocurcumin group compared with baseline (P < 0.001) and placebo group (P = 0.001 and P < 0.001, respectively). Significant decrease in disease activity was found in nanocurcumin group compared with placebo group (P = 0.044). Our study provided a promising view for desirable effects of nanocurcumin supplementation in improving immunological parameters and disease activity in BD.",2021,Treg cells frequency increased significantly in the nanocurcumin group compared with baseline (P < 0.001) and placebo group (P < 0.001).,"['36 BD subjects', 'Thirty-two patients (17 in the nanocurcumin and 15 in the placebo groups) completed the trial', ""Behçet's disease (BD""]","['nanocurcumin', 'Nanocurcumin supplementation', 'nanocurcumin capsule or placebo', 'placebo', 'nanocurcumin supplementation']","['FoxP3, TGF-β, IL-10, miRNA-25, and miRNA-106b mRNA expression levels', 'TGF)-β and interleukin (IL)-10', 'regulatory T cells', 'disease activity, Treg cells frequency and expression of related immunologic parameters including forkhead box protein P3 (Foxp3) transcription factor messenger RNA (mRNA) and microRNAs (miRNAs) such as miRNA-25 and miRNA-106b as well as cytokines including transforming growth factor ', 'disease activity', 'Treg cells frequency', 'regulatory T (Treg) cells frequency and function', 'serum TGF-β and IL-10']","[{'cui': 'C0004943', 'cui_str': ""Behcet's syndrome""}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0118111', 'cui_str': 'Forkhead Proteins'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",36.0,0.761652,Treg cells frequency increased significantly in the nanocurcumin group compared with baseline (P < 0.001) and placebo group (P < 0.001).,"[{'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Abbasian', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Khabbazi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Rojin', 'Initials': 'R', 'LastName': 'Farzaneh', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Malek Mahdavi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: aidamalek@gmail.com.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehrzad', 'Initials': 'M', 'LastName': 'Hajialilo', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2021.108237']
1934,34653721,Effectiveness of local anesthetic application methods in postoperative pain control in laparoscopic cholecystectomies; a randomised controlled trial.,"BACKGROUND


Laparoscopic cholecystectomy is a minimally invasive procedure that causes pain originating from parietal and visceral peritoneum. Many studies have been conducted to improve postoperative pain management and comfort of patients. Various methods such as local anesthetic injection (LAI) at trocar access points, intraperitoneal local anesthetic injection (IPLA), pneumoperitoneum pressure reduction, transversus abdominis plane block (TAPB), and reducing the number of trocars used during the operation were attempted to reduce postoperative pain.
METHODS


In this study, we compared LAI, TAPB and IPLA methods with the control group in which no local anesthetic was applied to reduce postoperative pain after laparoscopic cholecystectomy. We also demonstrated the effect of these methods on postoperative pain, need for additional analgesics, length of hospitalization, and patient satisfaction.
RESULTS


Overall, 160 patients aged 18-74 years who underwent laparoscopic cholecystectomy for cholelithiasis between October 2018 and August 2019 were included in the study and divided into four groups as follows: LAI group, TAPB group, IPLA group, and the control group without any intervention. Visual Analog Scale (VAS) values at 1, 2, 4, 6, 12, and 24 h in the control group were significantly higher than in the LAI, TAPB, and IPLA groups. Further, VAS values at 1, 2, 4, 6, 12, and 24 h in the IPLA group were significantly higher than in the LAI and TAPB groups. No significant difference was observed between the LAI and TAPB groups in terms of VAS values at 1, 2, 4, 6, and 24 h. VAS values at 12 h in the LAI group were significantly higher than in the TAPB group.
CONCLUSIONS


Peroperative local anesthetic administration methods were more effective in preventing pain after laparoscopic cholecystectomy compared to the control group. In addition to reducing postoperative pain, these methods reduced the need for postoperative analgesics and increased patient satisfaction.",2021,"No significant difference was observed between the LAI and TAPB groups in terms of VAS values at 1, 2, 4, 6, and 24 h. VAS values at 12 h in the LAI group were significantly higher than in the TAPB group.
","['laparoscopic cholecystectomies', '160 patients aged 18-74 years who underwent', 'for cholelithiasis between October 2018 and August 2019 were included in the study and divided into four groups as follows']","['TAPB', 'laparoscopic cholecystectomy', 'local anesthetic injection (LAI) at trocar access points, intraperitoneal local anesthetic injection (IPLA), pneumoperitoneum pressure reduction, transversus abdominis plane block (TAPB', 'local anesthetic application methods', 'IPLA', 'Laparoscopic cholecystectomy']","['postoperative pain control', 'postoperative pain', 'postoperative pain, need for additional analgesics, length of hospitalization, and patient satisfaction', 'VAS values', 'pain', 'Visual Analog Scale (VAS) values']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2830173', 'cui_str': 'Calcium-Independent Phospholipase A2'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",160.0,0.0741714,"No significant difference was observed between the LAI and TAPB groups in terms of VAS values at 1, 2, 4, 6, and 24 h. VAS values at 12 h in the LAI group were significantly higher than in the TAPB group.
","[{'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Ergin', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: dranilergin@gmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Timuçin Aydin', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: mtimucina@gmail.com.'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Çiyiltepe', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: drciyiltepe@gmail.com.'}, {'ForeName': 'Aziz Bora', 'Initials': 'AB', 'LastName': 'Karip', 'Affiliation': 'Istanbul Oncology Hospital, Digestive Surgery Department, Cevizli, Toros Street No:86, 34846, Maltepe, İstanbul, Turkey. Electronic address: borakarip@gmail.com.'}, {'ForeName': 'Mehmet Mahir', 'Initials': 'MM', 'LastName': 'Fersahoğlu', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: fersahoglu@yahoo.com.'}, {'ForeName': 'Yetkin', 'Initials': 'Y', 'LastName': 'Özcabi', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: yetkin-oz@hotmail.com.'}, {'ForeName': 'Birol', 'Initials': 'B', 'LastName': 'Ağca', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: birolagca@yahoo.com.'}, {'ForeName': 'Ahmet Yalin', 'Initials': 'AY', 'LastName': 'İşcan', 'Affiliation': 'Istanbul Unıversity Faculty of Medicine, General Surgery Department, Topkapı, Turgut Özal Millet Street, 34093, Fatih, İstanbul, Turkey. Electronic address: yaliniscan@gmail.com.'}, {'ForeName': 'Yasin', 'Initials': 'Y', 'LastName': 'Güneş', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: drysngunes@hotmail.com.'}, {'ForeName': 'Arzu Yildirim', 'Initials': 'AY', 'LastName': 'Ar', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752, Turkey. Electronic address: dr.arzuyildirim@hotmail.com.'}, {'ForeName': 'İksan', 'Initials': 'İ', 'LastName': 'Taşdelen', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: mftasdelen@gmail.com.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Memi Şoğlu', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: cerrah@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106134']
1935,34653650,Study design and interventions for a peer-delivered motivational interviewing group treatment for sexual and gender minority male sexual trauma survivors.,"Sexual abuse of boys and men is a public health problem that has received relatively little attention from clinical scholars and researchers. Given unique pathways for development of and recovery from trauma-related emotional distress, sexual abuse survivors who identify as men may require distinct psychosocial interventions to engage in formal mental health care and assist in symptom reduction. This paper describes the rationale for and methodology of a randomized controlled trial comparing the effectiveness of Motivational Interviewing (MI) versus MI with affirmative care (MI-AC) for sexual and gender minority men who have been sexually traumatized. This study is designed to randomly assign 356 participants to either condition of six online group sessions delivered by two trained peers with lived experience of sexual trauma. Assessments will be conducted at baseline, post-treatment, 60- and 120-day follow-up. The primary hypotheses are that participants assigned to MI-AC, compared to those in MI only, will report reduced symptoms of depression and increased levels of engagement in formal mental health treatment. Additional hypotheses relate to secondary outcome variables, including post-traumatic stress disorder, suicidality, and substance use.",2021,"The primary hypotheses are that participants assigned to MI-AC, compared to those in MI only, will report reduced symptoms of depression and increased levels of engagement in formal mental health treatment.","['sexual and gender minority men who have been sexually traumatized', '356 participants to either condition of six online group sessions delivered by two trained peers with lived experience of sexual trauma', 'sexual and gender minority male sexual trauma survivors', 'Sexual abuse of boys and men']","['motivational interviewing group treatment', 'Motivational Interviewing (MI) versus MI with affirmative care (MI-AC']","['post-traumatic stress disorder, suicidality, and substance use']","[{'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",356.0,0.128873,"The primary hypotheses are that participants assigned to MI-AC, compared to those in MI only, will report reduced symptoms of depression and increased levels of engagement in formal mental health treatment.","[{'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Ellis', 'Affiliation': 'Nova Southeastern University, Fort Lauderdale, FL, United States of America. Electronic address: amy.ellis@nova.edu.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States of America; VA Connecticut Healthcare System, West Haven, CT, United States of America.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Simiola', 'Affiliation': 'Kaiser Permanente, Center for Health Care Research, Honolulu, HI, United States of America.'}, {'ForeName': 'Margaret-Anne', 'Initials': 'MA', 'LastName': 'Mackintosh', 'Affiliation': 'Stat Craft, LLC, Brentwood, CA, United States of America.'}, {'ForeName': 'Chyrell', 'Initials': 'C', 'LastName': 'Bellamy', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Cook', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106597']
1936,34655997,Radiologist-patient consultation of imaging findings after neck ultrasonography: An opportunity to practice value-based radiology.,"OBJECTIVE


To investigate how patients experience a radiologist-patient consultation of imaging findings directly after neck ultrasonography (US), and how much time this consumes.
MATERIALS AND METHODS


This prospective randomized study included 109 consecutive patients who underwent neck US, of whom 44 had a radiologist-patient consultation of US results directly after the examination, and 65 who had not.
RESULTS


The median ratings of all healthcare quality metrics (friendliness of the radiologist, explanation of the radiologist, skill of the radiologist, radiologist's concern for comfort during the examination, radiologist's concern for patient questions/worries, overall rating of the examination, and likelihood of recommending the examination) were either good/high or very good/very high, without any significant differences between both patient groups. Patients who did not discuss the US results with the radiologist, were significantly more worried during the examination (P = 0.040) and had significantly higher anxiety levels after completion of the US examination (P = 0.027) than patients who discussed the US results with the radiologist. Fifty-one out of 55 responding patients (92.7%) indicated a radiologist-patient consultation of US results to be important. The median duration of US examinations that included a radiologist-patient consultation of US results was 7.57 min (range: 5.15-12.10 min), while the median duration of US examinations without a radiologist-patient consultation of US results was 7.34 min (range: 3.45-14.32 min), without any significant difference (P = 0.637).
CONCLUSION


A radiologist-patient consultation of imaging findings after neck US decreases patient anxiety, is desired by most patients, and does not significantly prolong total examination time.",2021,"Patients who did not discuss the US results with the radiologist, were significantly more worried during the examination (P = 0.040) and had significantly higher anxiety levels after completion of the US examination (P = 0.027) than patients who discussed the US results with the radiologist.","['Radiologist-patient consultation of imaging findings after neck ultrasonography', '109 consecutive patients who underwent neck US, of whom 44 had a radiologist-patient consultation of US results directly after the examination, and 65 who had not', 'patients experience a radiologist-patient consultation of imaging findings directly after neck ultrasonography (US']",[],"[""median ratings of all healthcare quality metrics (friendliness of the radiologist, explanation of the radiologist, skill of the radiologist, radiologist's concern for comfort during the examination, radiologist's concern for patient questions/worries, overall rating of the examination, and likelihood of recommending the examination"", 'patient anxiety', 'median duration of US examinations', 'anxiety levels', 'total examination time']","[{'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1287399', 'cui_str': 'Imaging finding'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",109.0,0.0250869,"Patients who did not discuss the US results with the radiologist, were significantly more worried during the examination (P = 0.040) and had significantly higher anxiety levels after completion of the US examination (P = 0.027) than patients who discussed the US results with the radiologist.","[{'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Kasalak', 'Affiliation': 'Medical Imaging Center, Department of Radiology, Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, the Netherlands. Electronic address: o.kasalak@umcg.nl.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Yakar', 'Affiliation': 'Medical Imaging Center, Department of Radiology, Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Rudi A J O', 'Initials': 'RAJO', 'LastName': 'Dierckx', 'Affiliation': 'Medical Imaging Center, Department of Radiology, Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Kwee', 'Affiliation': 'Medical Imaging Center, Department of Radiology, Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, the Netherlands.'}]",Clinical imaging,['10.1016/j.clinimag.2021.09.022']
1937,34655959,Rationale and design of a mechanistic clinical trial of JAK inhibition to prevent ventilator-induced diaphragm dysfunction.,"INTRODUCTION


Ventilator-induced diaphragm dysfunction (VIDD) is an important phenomenon that has been repeatedly demonstrated in experimental and clinical models of mechanical ventilation. Even a few hours of MV initiates signaling cascades that result in, first, reduced specific force, and later, atrophy of diaphragm muscle fibers. This severe, progressive weakness of the critical ventilatory muscle results in increased duration of MV and thus increased MV-associated complications/deaths. A drug that could prevent VIDD would likely have a major positive impact on intensive care unit outcomes. We identified the JAK/STAT pathway as important in VIDD and then demonstrated that JAK inhibition prevents VIDD in rats. We subsequently developed a clinical model of VIDD demonstrating reduced contractile force of isolated diaphragm fibers harvested after ∼7 vs ∼1 h of MV during a thoracic surgical procedure.
MATERIALS AND METHODS


The NIH-funded clinical trial that has been initiated is a prospective, placebo controlled trial: subjects undergoing esophagectomy are randomized to receive 6 preoperative doses of the FDA-approved JAK inhibitor Tofacitinib (commonly used for rheumatoid arthritis) vs. placebo. The primary outcome variable will be the difference in the reduction that occurs in force generation of diaphragm single muscle fibers (normalized to their cross-sectional area), in the Tofacitinib vs. placebo subjects, over 6 h of MV.
DISCUSSION


This trial represents a first-in-human, mechanistic clinical trial of a drug to prevent VIDD. It will provide proof-of-concept in human subjects whether JAK inhibition prevents clinical VIDD, and if successful, will support an ICU-based clinical trial that would determine whether JAK inhibition impacts clinical outcome variables such as duration of MV and mortality.",2021,We identified the JAK/STAT pathway as important in VIDD and then demonstrated that JAK inhibition prevents VIDD in rats.,['controlled trial: subjects undergoing esophagectomy'],"['FDA-approved JAK inhibitor Tofacitinib', 'JAK inhibition', 'placebo']",['force generation of diaphragm single muscle fibers (normalized to their cross-sectional area'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.305756,We identified the JAK/STAT pathway as important in VIDD and then demonstrated that JAK inhibition prevents VIDD in rats.,"[{'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Shrager', 'Affiliation': 'Division of Thoracic Surgery, Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA; Veterans Affair Palo Alto Health Care System, Palo Alto, CA, USA. Electronic address: shrager@stanford.edu.'}, {'ForeName': 'Yoyo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Division of Thoracic Surgery, Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA; Veterans Affair Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Myung', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Division of Thoracic Surgery, Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA; Veterans Affair Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Nesbit', 'Affiliation': 'Division of Thoracic Surgery, Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Trope', 'Affiliation': 'Division of Thoracic Surgery, Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Konsker', 'Affiliation': 'Division of Thoracic Surgery, Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA; Veterans Affair Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Fatodu', 'Affiliation': 'Division of Thoracic Surgery, Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA; Veterans Affair Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Berry', 'Affiliation': 'Division of Thoracic Surgery, Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Poulstides', 'Affiliation': 'Department of Surgery, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Norton', 'Affiliation': 'Department of Surgery, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Burdon', 'Affiliation': 'Division of Thoracic Surgery, Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA; Veterans Affair Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Backhus', 'Affiliation': 'Division of Thoracic Surgery, Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA; Veterans Affair Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cooke', 'Affiliation': 'Department of Biochemistry and Biophysics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Huibin', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Division of Thoracic Surgery, Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA; Veterans Affair Palo Alto Health Care System, Palo Alto, CA, USA.'}]",Respiratory medicine,['10.1016/j.rmed.2021.106620']
1938,34655945,Varenicline as a treatment for cannabis use disorder: A placebo-controlled pilot trial.,"BACKGROUND


An efficacious pharmacotherapy for cannabis use disorder (CUD) has yet to be established. This study preliminarily evaluated the safety and efficacy of varenicline for CUD in a proof-of-concept clinical trial.
METHODS


Participants in this 6-week randomized, placebo-controlled pilot trial received either varenicline (n = 35) or placebo (n = 37), added to a brief motivational enhancement therapy intervention. Outcomes included cannabis withdrawal, cannabis abstinence, urine cannabinoid levels, percent cannabis use days, and cannabis sessions per day.
RESULTS


Both treatment groups noted significant decreases in self-reported cannabis withdrawal, percentage of days used, and use sessions per day during treatment compared to baseline. While this pilot trial was not powered to detect statistically significant between-group differences, participants randomized to varenicline evidenced numerically greater rates of self-reported abstinence at the final study visit [Week 6 intent-to-treat (ITT): Varenicline: 17.1% vs. Placebo: 5.4%; RR = 3.2 (95% CI: 0.7,14.7)]. End-of-treatment urine creatinine corrected cannabinoid levels were numerically lower in the varenicline group and higher in the placebo group compared to baseline [Change from baseline: Varenicline -1.7 ng/mg (95% CI: -4.1,0.8) vs. Placebo: 1.9 ng/mg (95% CI: -0.4,4.3); Δ = 3.5 (95% CI: 0.1,6.9)]. Adverse events related to study treatment did not reveal new safety signals.
CONCLUSIONS


Findings support the feasibility of conducting clinical trials of varenicline as a candidate pharmacotherapy for CUD, and indicate that a full-scale efficacy trial, powered based on effect sizes and variability yielded in this study, is warranted.",2021,"Both treatment groups noted significant decreases in self-reported cannabis withdrawal, percentage of days used, and use sessions per day during treatment compared to baseline.","['cannabis use disorder (CUD', 'Participants']","['Varenicline', 'Placebo', 'motivational enhancement therapy intervention', 'placebo', 'varenicline']","['self-reported cannabis withdrawal', 'safety and efficacy', 'rates of self-reported abstinence', 'cannabis withdrawal, cannabis abstinence, urine cannabinoid levels, percent cannabis use days, and cannabis sessions per day']","[{'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C3840212', 'cui_str': 'Cannabis withdrawal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0729815', 'cui_str': 'Urine cannabinoid measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439505', 'cui_str': '/day'}]",,0.329519,"Both treatment groups noted significant decreases in self-reported cannabis withdrawal, percentage of days used, and use sessions per day during treatment compared to baseline.","[{'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'McRae-Clark', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America; Ralph H. Johnson VA Medical Center, Charleston, SC, United States of America. Electronic address: mcraeal@musc.edu.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United States of America.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Sherman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Squeglia', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Sahlem', 'Affiliation': 'Department of Psychiatry, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Wagner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109111']
1939,34643543,Kinesiotherapy With Exergaming as a Potential Modulator of Epigenetic Marks and Clinical Functional Variables of Older Women: Protocol for a Mixed Methods Study.,"BACKGROUND


Kinesiotherapy is an option to mitigate worsening neuropsychomotor function due to human aging. Moreover, exergames are beneficial for the practice of physical therapy by older patients. Physical exercise interventions are known to alter the epigenome, but little is known about their association with exergames.
OBJECTIVE


We aim to evaluate the effects of kinesiotherapy with exergaming on older women's epigenetic marks and cognitive ability, as well as on their clinical functional variables. Our hypothesis states that this kind of therapy can elicit equal or even better outcomes than conventional therapy.
METHODS


We will develop a virtual clinic exergame with 8 types of kinesiotherapy exercises. Afterward, we will conduct a 1:1 randomized clinical trial to compare the practice of kinesiotherapy with exergames (intervention group) against conventional kinesiotherapy (control group). A total of 24 older women will be enrolled for 1-hour sessions performed twice a week, for 6 weeks, totaling 12 sessions. We will assess outcomes using epigenetic blood tests, the Montreal Cognitive Assessment test, the Timed Up and Go test, muscle strength grading in a hydraulic dynamometer, and the Game Experience Questionnaire at various stages.
RESULTS


The project was funded in October 2019. Game development took place in 2020. Patient recruitment and a clinical trial are planned for 2021.
CONCLUSIONS


Research on this topic is likely to significantly expand the understanding of kinesiotherapy and the impact of exergames. To the best of our knowledge, this may be one of the first studies exploring epigenetic outcomes of exergaming interventions.
TRIAL REGISTRATION


Brazilian Clinical Trials Registry/Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR-9tdrmw; https://ensaiosclinicos.gov.br/rg/RBR-9tdrmw.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/32729.",2021,"CONCLUSIONS


Research on this topic is likely to significantly expand the understanding of kinesiotherapy and the impact of exergames.","['24 older women', 'older patients', 'Older Women']","['Physical exercise interventions', 'kinesiotherapy with exergames (intervention group) against conventional kinesiotherapy (control group', 'Kinesiotherapy With Exergaming', 'kinesiotherapy', 'kinesiotherapy exercises']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1096702', 'cui_str': 'Kinesitherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],24.0,0.152282,"CONCLUSIONS


Research on this topic is likely to significantly expand the understanding of kinesiotherapy and the impact of exergames.","[{'ForeName': 'Patrícia Paula Bazzanello', 'Initials': 'PPB', 'LastName': 'Henrique', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Fabrízzio Martin Pelle', 'Initials': 'FMP', 'LastName': 'Perez', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Osvaldo Henrique Cemin', 'Initials': 'OHC', 'LastName': 'Becker', 'Affiliation': 'Institute of Exact Sciences and Geosciences, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Ericles Andrei', 'Initials': 'EA', 'LastName': 'Bellei', 'Affiliation': 'Institute of Exact Sciences and Geosciences, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Daiana', 'Initials': 'D', 'LastName': 'Biduski', 'Affiliation': 'Institute of Exact Sciences and Geosciences, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Arthiese', 'Initials': 'A', 'LastName': 'Korb', 'Affiliation': 'Department of Physiotherapy, Regional Integrated University of High Uruguay and Missions, Erechim, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Graduate Program in Biosciences and Rehabilitation, Porto Alegre Institute of the Methodist Church, Porto Alegre, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Graduate Program in Biosciences and Rehabilitation, Porto Alegre Institute of the Methodist Church, Porto Alegre, Brazil.'}, {'ForeName': 'Viviane Rostirola', 'Initials': 'VR', 'LastName': 'Elsner', 'Affiliation': 'Graduate Program in Biological Sciences: Physiology, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Ana Carolina Bertoletti', 'Initials': 'ACB', 'LastName': 'De Marchi', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, University of Passo Fundo, Passo Fundo, Brazil.'}]",JMIR research protocols,['10.2196/32729']
1940,34643541,Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial.,"BACKGROUND


Major depressive disorder (MDD) accounts for 40.5% of disability-adjusted life years caused by mental and substance use disorders. Barriers such as stigma and financial and physical access to care have been reported, highlighting the need for innovative, accessible, and cost-effective psychological interventions. The effectiveness of supportive SMS text messaging in alleviating depression symptoms has been proven in clinical trials, but this approach can only help those with mobile phones.
OBJECTIVE


This paper presents the protocol for a study that will aim to evaluate the feasibility, comparative effectiveness, and user satisfaction of daily supportive email messaging as an effective strategy compared to daily supportive text messaging as part of the treatment of patients with MDD.
METHODS


This trial will be carried out using a hybrid type II implementation-effectiveness design. This design evaluates the effectiveness of an implementation strategy or intervention, while also evaluating the implementation context associated with the intervention. Patients with MDD receiving usual care will be randomized to receive either daily supportive email messaging or daily supportive text messaging of the same content for 6 months. The Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7, and the 5-item World Health Organization Well-Being Index will be used to evaluate the effectiveness of both strategies. The implementation evaluation will be guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, as well as the Consolidated Framework for Implementation Research. All outcome measures will be analyzed using descriptive and inferential statistics. Qualitative data will be analyzed using thematic analysis.
RESULTS


Data collection for this trial began in April 2021. We expect the study results to be available within 18 months of study commencement. The results will shed light on the feasibility, acceptability, and effectiveness of using automated emails as a strategy for delivering supportive messages to patients with MDD in comparison to text messaging.
CONCLUSIONS


The outcome of this trial will have translational impact on routine patient care and access to mental health, as well as potentially support mental health policy decision-making for health care resource allocation.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04638231; https://clinicaltrials.gov/ct2/show/NCT04638231.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/29495.",2021,"The results will shed light on the feasibility, acceptability, and effectiveness of using automated emails as a strategy for delivering supportive messages to patients with MDD in comparison to text messaging.
","['patients with MDD', 'Patients with MDD receiving usual care']","['daily supportive email messaging or daily supportive text messaging', 'supportive SMS text messaging', 'Text Messaging Versus Email Messaging to Support Patients']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],,0.0443585,"The results will shed light on the feasibility, acceptability, and effectiveness of using automated emails as a strategy for delivering supportive messages to patients with MDD in comparison to text messaging.
","[{'ForeName': 'Medard Kofi', 'Initials': 'MK', 'LastName': 'Adu', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Reham', 'Initials': 'R', 'LastName': 'Shalaby', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ejemai', 'Initials': 'E', 'LastName': 'Eboreime', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Adegboyega', 'Initials': 'A', 'LastName': 'Sapara', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Nnamdi', 'Initials': 'N', 'LastName': 'Nkire', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Chawla', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Chidi', 'Initials': 'C', 'LastName': 'Chima', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Achor', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Osiogo', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chue', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Greenshaw', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Vincent Israel', 'Initials': 'VI', 'LastName': 'Agyapong', 'Affiliation': 'Department of Psychiatry,  Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}]",JMIR research protocols,['10.2196/29495']
1941,34643532,The Use of Task Shifting to Improve Treatment Engagement in an Internet-Based Mindfulness Intervention Among Chinese University Students: Randomized Controlled Trial.,"BACKGROUND


Traditional in-person psychotherapies are incapable of addressing global mental health needs. Use of computer-based interventions is one promising solution for closing the gap between the amount of global mental health treatment needed and received.
OBJECTIVE


Although many meta-analyses have provided evidence supporting the efficacy of self-guided, computer-based interventions, most report low rates of treatment engagement (eg, high attrition and low adherence). The aim of this study is to investigate the efficacy of an adjunctive treatment component that uses task shifting, wherein mental health care is provided by nonspecialist peer counselors to enhance engagement in an internet-based, self-directed, evidence-based mindfulness intervention among Chinese university students.
METHODS


From 3 universities across China, 54 students who reported at least mild stress, anxiety, or depression were randomly assigned to a 4-week internet-based mindfulness intervention (MIND) or to the intervention plus peer counselor support (MIND+), respectively. Be Mindful delivers all the elements of mindfulness-based cognitive therapy in an internet-based, 4-week course. Participants completed daily monitoring of mindfulness practice and mood, as well as baseline and posttreatment self-reported levels of depression, anxiety, stress, and trait mindfulness. We screened 56 volunteer peer counselor candidates who had no former training in the delivery of mental health services. Of these, 10 were invited to participate in a day-long training, and 4 were selected. Peer counselors were instructed to provide 6 brief (15-20 minute) sessions each week, to help encouraging participants to complete the internet-based intervention. Peer counselors received weekly web-based group supervision.
RESULTS


For both conditions, participation in the internet-based intervention was associated with significant improvements in mindfulness and mental health outcomes. The pre-post effect sizes (Cohen d) for mindfulness, depression, anxiety, and stress were 0.55, 0.95, 0.89, and 1.13, respectively. Participants assigned to the MIND+ (vs MIND) condition demonstrated significantly less attrition and more adherence, as indicated by a greater likelihood of completing posttreatment assessments (16/27, 59% vs 7/27, 26%; χ 2 1 =6.1; P=.01) and a higher percentage of course completion (72.6/100, 72.6% vs 50.7/100, 50.7%; t 52 =2.10; P=.04), respectively. No significant between-group differences in daily frequency and duration of mindfulness practice were observed. Multilevel logistic growth models showed that MIND+ participants reported significantly greater pre-post improvements in daily stress ratings (interaction estimate 0.39, SE 0.18; t 317 =2.29; P=.02) and depression (interaction estimate 0.38, SE 0.16; t 330 =2.37; P=.02) than those in the MIND condition.
CONCLUSIONS


This study provides new insights into effective ways of leveraging technology and task shifting to implement large-scale mental health initiatives that are financially feasible, easily transportable, and quickly scalable in low-resource settings. The findings suggest that volunteer peer counselors receiving low-cost, low-intensity training and supervision may significantly improve participants' indices of treatment engagement and mental health outcomes in an internet-based mindfulness intervention among Chinese university students.",2021,"For both conditions, participation in the internet-based intervention was associated with significant improvements in mindfulness and mental health outcomes.","['Chinese University Students', 'From 3 universities across China, 54 students who reported at least mild stress, anxiety, or depression', 'Chinese university students', '56 volunteer peer counselor candidates who had no former training in the delivery of mental health services']","['4-week internet-based mindfulness intervention (MIND) or to the intervention plus peer counselor support (MIND', 'Internet-Based Mindfulness Intervention', 'internet-based mindfulness intervention', 'Peer counselors received weekly web-based group supervision', 'MIND']","['attrition and more adherence', 'mindfulness, depression, anxiety, and stress', ""participants' indices of treatment engagement and mental health outcomes"", 'daily frequency and duration of mindfulness practice', 'depression, anxiety, stress, and trait mindfulness', 'mindfulness and mental health outcomes', 'course completion', 'daily stress ratings']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.0383115,"For both conditions, participation in the internet-based intervention was associated with significant improvements in mindfulness and mental health outcomes.","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, Pitzer College, Claremont, CA, United States.'}, {'ForeName': 'Tory A', 'Initials': 'TA', 'LastName': 'Eisenlohr-Moul', 'Affiliation': 'Neuropsychiatric Institute, Department of Psychiatry, University of Illinois at Chicago College of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Weisman', 'Affiliation': 'Pitzer College, Claremont, CA, United States.'}, {'ForeName': 'M Zachary', 'Initials': 'MZ', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Psychology & Neuroscience, Duke University, Durham, NC, United States.'}]",JMIR formative research,['10.2196/25772']
1942,34647777,Randomized controlled trial testing a video-text tobacco cessation intervention among economically disadvantaged African American adults.,"OBJECTIVE


This pilot study tested the acceptability and short-term outcomes of a culturally specific mobile health (mHealth) intervention ( Path2Quit ) in a sample of economically disadvantaged African American adults. We hypothesized that  Path2Quit  would demonstrate greater acceptability, biochemically verified abstinence, and promote nicotine replacement therapy (NRT) use compared with a standard text-messaging program.
METHOD


In a 2-arm pilot randomized trial, adults who sought to quit smoking ( N  = 119) received either  Path2Quit  or the National Cancer Institute's (NCI) SmokefreeTXT, both combined with a brief behavioral counseling session plus 2 weeks of NRT. Outcomes included acceptability (intervention evaluation and use), NRT utilization, 24-hr quit attempts, self-reported 7-day point prevalence abstinence (ppa), and biochemically verified smoking abstinence at the 6-week follow-up.
RESULTS


Participants were 52% female/48% male, mostly single (60%), completed ≥ 12 years of education (83%), middle-aged, and 63% reported a household income < $10K/year. Participants smoked 11 ( SD  = 8.2) cigarettes/day for 25 ( SD  = 16) years, and reported low nicotine dependence. There were no differences in intervention evaluations or use ( p s > .05), yet  Path2Quit  led to significantly greater NRT utilization at follow-up ( p  < .05). There was no difference in quit attempts between conditions or 7-day ppa ( p  > .05). However,  Path2Quit  resulted in significantly greater carbon monoxide confirmed ppa (adjusted odds ratio [AOR] = 3.55; 95% CI [1.32, 9.54]) at the 6-week follow-up.
CONCLUSIONS


A culturally specific mHealth intervention demonstrated positive effects on NRT use and short-term abstinence. Additional research in a larger sample and with long-term follow-up is warranted. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"There were no differences in intervention evaluations or use ( p s > .05), yet  Path2Quit  led to significantly greater NRT utilization at follow-up ( p  < .05).","['adults who sought to quit smoking ( N  = 119) received either', 'a sample of economically disadvantaged African American adults', 'Participants were 52% female/48% male, mostly single (60%), completed ≥ 12 years of education (83%), middle-aged, and 63% reported a household income < $10K/year', 'economically disadvantaged African American adults', 'Participants smoked 11 ( SD  = 8.2) cigarettes/day for 25 ( SD  = 16) years, and reported low nicotine dependence']","['nicotine replacement therapy (NRT', ""Path2Quit  or the National Cancer Institute's (NCI) SmokefreeTXT, both combined with a brief behavioral counseling session plus 2 weeks of NRT"", 'video-text tobacco cessation intervention', 'culturally specific mobile health (mHealth) intervention ( Path2Quit ']","['NRT utilization', 'acceptability (intervention evaluation and use), NRT utilization, 24-hr quit attempts, self-reported 7-day point prevalence abstinence (ppa), and biochemically verified smoking abstinence', 'quit attempts between conditions or 7-day ppa', 'carbon monoxide confirmed ppa']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031495', 'cui_str': 'Phenylpropanolamine'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]",,0.0644297,"There were no differences in intervention evaluations or use ( p s > .05), yet  Path2Quit  led to significantly greater NRT utilization at follow-up ( p  < .05).","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Webb Hooper', 'Affiliation': 'Case Comprehensive Cancer Center.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Miller', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Saldivar', 'Affiliation': 'Case School of Engineering.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Mitchell', 'Affiliation': 'Case Comprehensive Cancer Center.'}, {'ForeName': 'Lacresha', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Case Comprehensive Cancer Center.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Burns', 'Affiliation': 'Case Comprehensive Cancer Center.'}, {'ForeName': 'Ming-Chun', 'Initials': 'MC', 'LastName': 'Huang', 'Affiliation': 'Case School of Engineering.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000691']
1943,34651263,Dapagliflozin: A Review in Symptomatic Heart Failure with Reduced Ejection Fraction.,"Dapagliflozin [Farxiga ®  (USA); Forxiga ®  (EU)], a sodium-glucose cotransporter 2 (SGLT2) inhibitor, was recently approved in the USA and the EU for the treatment of adults with symptomatic heart failure with reduced ejection fraction (HFrEF). The cardiovascular (CV) benefits of dapagliflozin were first observed in the DECLARE-TIMI 58 trial, in which dapagliflozin 10 mg/day significantly reduced the risk of CV death or hospitalization for HF in patients with type 2 diabetes mellitus (T2DM) who had or were at risk for atherosclerotic CV disease. In the subsequent DAPA-HF trial, dapagliflozin 10 mg/day in addition to standard of care was associated with a significantly lower risk of worsening HF or CV death than placebo in patients with HFrEF, regardless of the presence or absence of T2DM. The benefits of dapagliflozin also remained consistent regardless of background HF therapies. Dapagliflozin was generally well tolerated, with an overall safety profile consistent with its known safety profile in other indications. In conclusion, dapagliflozin is an effective and generally well-tolerated treatment that represents a valuable new addition to the options available for symptomatic HFrEF.",2021,"Dapagliflozin was generally well tolerated, with an overall safety profile consistent with its known safety profile in other indications.","['patients with type\xa02 diabetes mellitus (T2DM) who had or were at risk for atherosclerotic CV disease', 'adults with symptomatic heart failure with reduced ejection fraction (HFrEF', 'Symptomatic Heart Failure with Reduced Ejection Fraction']","['Dapagliflozin', 'Dapagliflozin [Farxiga ®  (USA); Forxiga ®  (EU', 'dapagliflozin', 'placebo']","['cardiovascular (CV) benefits of dapagliflozin', 'risk of worsening HF or CV death', 'risk of CV death or hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3700957', 'cui_str': 'Farxiga'}, {'cui': 'C3852722', 'cui_str': 'forxiga'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.125205,"Dapagliflozin was generally well tolerated, with an overall safety profile consistent with its known safety profile in other indications.","[{'ForeName': 'Hannah A', 'Initials': 'HA', 'LastName': 'Blair', 'Affiliation': 'Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-021-00503-8']
1944,34654579,A self-administered virtual reality intervention increases COVID-19 vaccination intention.,"Effective interventions for increasing people's intention to get vaccinated are crucial for global health, especially considering COVID-19. We devised a novel intervention using virtual reality (VR) consisting of a consultation with a general practitioner for communicating the benefits of COVID-19 vaccination and, in turn, increasing the intention to get vaccinated against COVID-19. We conducted a preregistered online experiment with a 2×2 between-participant design. People with eligible VR headsets were invited to install our experimental application and complete the ten minute virtual consultation study at their own discretion. Participants were randomly assigned across two age conditions (young or old self-body) and two communication conditions (with provision of personal benefit of vaccination only, or collective and personal benefit). The primary outcome was vaccination intention (score range 1-100) measured three times: immediately before and after the study, as well as one week later. Five-hundred-and-seven adults not vaccinated against COVID-19 were recruited. Among the 282 participants with imperfect vaccination intentions (<100), the VR intervention increased pre-to-post vaccination intentions across intervention conditions (mean difference 8.6, 95% CI 6.1 to 11.1,p<0.0001). The pre-to-post difference significantly correlated with the vaccination intention one week later, ρ=0.20,p<0.0001. The VR intervention was effective in increasing COVID-19 vaccination intentions both when only personal benefits and personal and collective benefits of vaccination were communicated, with significant retention one week after the intervention. Utilizing recent evidence from health psychology and embodiment research to develop immersive environments with customized and salient communication efforts could therefore be an effective tool to complement public health campaigns.",2021,"The VR intervention was effective in increasing COVID-19 vaccination intentions both when only personal benefits and personal and collective benefits of vaccination were communicated, with significant retention one week after the intervention.","['People with eligible VR headsets', '282 participants with imperfect vaccination intentions (<100', 'Five-hundred-and-seven adults not vaccinated against COVID-19 were recruited']","['novel intervention using virtual reality (VR', 'communication conditions (with provision of personal benefit of vaccination only, or collective and personal benefit', 'VR intervention']","['COVID-19 vaccination intention', 'VR intervention increased pre-to-post vaccination intentions', 'vaccination intention (score range 1-100', 'COVID-19 vaccination intentions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}]",282.0,0.121308,"The VR intervention was effective in increasing COVID-19 vaccination intentions both when only personal benefits and personal and collective benefits of vaccination were communicated, with significant retention one week after the intervention.","[{'ForeName': 'Aske', 'Initials': 'A', 'LastName': 'Mottelson', 'Affiliation': 'Department of Digital Design, IT University of Copenhagen, Denmark. Electronic address: asmo@itu.dk.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Vandeweerdt', 'Affiliation': 'Department of Political Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Atchapero', 'Affiliation': 'Department of Psychology, University of Copenhagen, Denmark.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Luong', 'Affiliation': 'Department of Computer Science, ETH Zürich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Holz', 'Affiliation': 'Department of Computer Science, ETH Zürich, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Böhm', 'Affiliation': 'Department of Psychology, University of Copenhagen, Denmark; Faculty of Psychology, University of Vienna, Austria; Copenhagen Center for Social Data Science (SODAS), University of Copenhagen, Denmark.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Makransky', 'Affiliation': 'Department of Psychology, University of Copenhagen, Denmark.'}]",Vaccine,['10.1016/j.vaccine.2021.10.004']
1945,34653648,"Japanese project for telepsychiatry evaluation during COVID-19: Treatment comparison trial (J-PROTECT): Rationale, design, and methodology.","INTRODUCTION


The COVID-19 pandemic has had a profound impact on the mental health of people around the world. Anxiety related to infection, stress and stigma caused by the forced changes in daily life have reportedly increased the incidence and symptoms of depression, anxiety disorder and obsessive-compulsive disorder. Under such circumstances, telepsychiatry is gaining importance and attracting a great deal of attention. However, few large pragmatic clinical trials on the use of telepsychiatry targeting multiple psychiatric disorders have been conducted to date.
METHODS


The targeted study cohort will consist of adults (>18 years) who meet the DSM-5 diagnostic criteria for either (1) depressive disorders, (2) anxiety disorders, or (3) obsessive-compulsive and related disorders. Patients will be assigned in a 1:1 ratio to either a ""telepsychiatry group"" (at least 50% of treatments to be conducted using telemedicine, with at least one face-to-face treatment [FTF] within six months) or an ""FTF group"" (all treatments to be conducted FTF, with no telemedicine). Both groups will receive the usual treatment covered by public medical insurance. The study will utilize a master protocol design in that there will be primary and secondary outcomes for the entire group regardless of diagnosis, as well as the outcomes for each individual disorder group.
DISCUSSION


This study will be a non-inferiority trial to test that the treatment effect of telepsychiatry is not inferior to that of FTF alone. This study will provide useful insights into the effect of the COVID-19 pandemic on the practice of psychiatry.
TRIAL REGISTRATION


jRCT1030210037, Japan Registry of Clinical Trials (jRCT).",2021,This study will be a non-inferiority trial to test that the treatment effect of telepsychiatry is not inferior to that of FTF alone.,"['adults (>18\u202fyears) who meet the DSM-5 diagnostic criteria for either (1) depressive disorders, (2) anxiety disorders, or (3) obsessive-compulsive and related disorders']","['telepsychiatry group"" (at least 50% of treatments to be conducted using telemedicine, with at least one face-to-face treatment [FTF', 'FTF group"" (all treatments to be conducted FTF, with no telemedicine']","['incidence and symptoms of depression, anxiety disorder and obsessive-compulsive disorder']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]",,0.147434,This study will be a non-inferiority trial to test that the treatment effect of telepsychiatry is not inferior to that of FTF alone.,"[{'ForeName': 'Taishiro', 'Initials': 'T', 'LastName': 'Kishimoto', 'Affiliation': 'Hills Joint Research Laboratory for Future Preventive Medicine and Wellness, Keio University School of Medicine, #7F Roppongi Hills, North Tower 6-2-31 Roppongi, Minato-ku, Tokyo 106-0032, Japan. Electronic address: taishiro-k@mti.biglobe.ne.jp.'}, {'ForeName': 'Shotaro', 'Initials': 'S', 'LastName': 'Kinoshita', 'Affiliation': 'Hills Joint Research Laboratory for Future Preventive Medicine and Wellness, Keio University School of Medicine, #7F Roppongi Hills, North Tower 6-2-31 Roppongi, Minato-ku, Tokyo 106-0032, Japan; Graduate School of Medicine, International University of Health and Welfare, 4-1-26 Akasaka, Minato-ku, Tokyo 107-8402, Japan.'}, {'ForeName': 'Shogyoku', 'Initials': 'S', 'LastName': 'Bun', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan; Sato Hospital, 948-1 Kunugizuka, Nanyo, Yamagata 999-2221, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan.'}, {'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Kitazawa', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Sado', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Takamiya', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakamae', 'Affiliation': 'Department of Psychiatry, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo, Kyoto, Kyoto 602-8566, Japan.'}, {'ForeName': 'Yoshinari', 'Initials': 'Y', 'LastName': 'Abe', 'Affiliation': 'Department of Psychiatry, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo, Kyoto, Kyoto 602-8566, Japan.'}, {'ForeName': 'Tetsufumi', 'Initials': 'T', 'LastName': 'Kanazawa', 'Affiliation': 'Department of Neuropsychiatry, Osaka Medical and Pharmaceutical University, 2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Kawabata', 'Affiliation': 'Department of Neuropsychiatry, Osaka Medical and Pharmaceutical University, 2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tomita', 'Affiliation': 'Department of Psychiatry, Tohoku University Hospital, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi 980-8573, Japan; Department of Psychiatry, Tohoku University Graduate School of Medicine, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi 980-8573, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Department of Psychiatry, Tohoku University Hospital, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi 980-8573, Japan.'}, {'ForeName': 'Akitoyo', 'Initials': 'A', 'LastName': 'Hishimoto', 'Affiliation': 'Department of Psychiatry, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Asami', 'Affiliation': 'Department of Psychiatry, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Suda', 'Affiliation': 'Department of Psychiatry, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Himorogi Psychiatric Institute, Ichigaya-Asukara Bldg. 1F2F, 2-31-3 Ichigayatamachi, Shinjuku, Tokyo 162-0843, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Amagai', 'Affiliation': 'Amagai Mental Clinic, Kitami Bldg. 3F, 1-4-20 Kamiooka-nishi, Konan, Yokohama, Kanagawa 233-0002, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Sakuma', 'Affiliation': 'Asaka Hospital, 45 Kyotan, Sasagawa, Asakamachi, Koriyama, Fukushima 963-0198, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Kida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan; Asaka Hospital, 45 Kyotan, Sasagawa, Asakamachi, Koriyama, Fukushima 963-0198, Japan.'}, {'ForeName': 'Michitaka', 'Initials': 'M', 'LastName': 'Funayama', 'Affiliation': 'Department of Neuropsychiatry, Ashikaga Red Cross Hospital, 284-1 Yobe, Ashikaga, Tochigi 326-0843, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kimura', 'Affiliation': 'Department of Psychiatry, Gakuji-kai Kimura Hospital, 6-19, Higashi Honcho, Chuo-ku, Chiba, Chiba 260-0004, Japan; Department of Psychiatry, School of Medicine, International University of Health and Welfare, 4-3, Kozunomori, Narita, Chiba 286-8686, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': 'Department of Psychiatry, School of Medicine, International University of Health and Welfare, 4-3, Kozunomori, Narita, Chiba 286-8686, Japan.'}, {'ForeName': 'Shuichiro', 'Initials': 'S', 'LastName': 'Fujiwara', 'Affiliation': 'Kanazawabunko Yell Clinic, Kanazawa Bunko Park Homes 102, Kamariyahigashi, Kanazawa, Yokohama, Kanagawa 236-0042, Japan.'}, {'ForeName': 'Kiichiro', 'Initials': 'K', 'LastName': 'Nagao', 'Affiliation': 'Neyagawa Sanatoriumu, 2370-6 Neyagawakoen, Neyagawa, Osaka, Osaka 572-0854, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Sugiyama', 'Affiliation': 'Numazu Chuo Hospital, 24-1 Nakase-cho, Numazu, Shizuoka 410-8575, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Takamiya', 'Affiliation': 'Takamiya Hospital, 1931 Omachikou, Yoshimura, Miyazaki, Miyazaki 880-0841, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kodama', 'Affiliation': 'Takamiya Hospital, 1931 Omachikou, Yoshimura, Miyazaki, Miyazaki 880-0841, Japan.'}, {'ForeName': 'Takaharu', 'Initials': 'T', 'LastName': 'Azekawa', 'Affiliation': 'Shioiri Mental Clinic, 2-7-1 Shioiri, Yokosuka, Kanagawa, 238-0042, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2021.106596']
1946,34653566,An intelligent insole system with personalised digital feedback reduces foot pressures during daily life: An 18-month randomised controlled trial.,"AIMS


High plantar pressure is a major risk factor in the development of diabetic foot ulcers (DFUs) and recent evidence shows plantar pressure feedback reduces DFU recurrence. This study investigated whether continued use of an intelligent insole system by patients at high-risk of DFUs causes a reduction in plantar pressures.
METHODS


Forty-six patients with diabetic peripheral neuropathy and previous DFU were randomised to intervention (IG) or control groups (CG). Patients received an intelligent insole system, consisting of pressure-sensing insoles and digital watch. Patients wore the device during all daily activity for 18-months or until ulceration, and integrated pressure was recorded continuously. The device provided high-pressure feedback to IG only via audio-visual-vibrational alerts. High-pressure parameters at the whole foot, forefoot and rearfoot were compared between groups, with multilevel binary logistic regression analysis.
RESULTS


CG experienced more high-pressure bouts over time than IG across all areas of the foot (P < 0.05). Differences between groups became apparent >16 weeks of wearing the device.
CONCLUSIONS


Continuous plantar pressure feedback via an intelligent insole system reduces number of bouts of high-pressure in patients at high-risk of DFU. These findings suggest that patients were learning which activities generated high-pressure, and pre-emptively offloading to avoid further alerts.",2021,"RESULTS


CG experienced more high-pressure bouts over time than IG across all areas of the foot (P<0.05).","['patients at high-risk of DFUs causes a reduction in plantar pressures', 'Forty-six patients with diabetic peripheral neuropathy and previous DFU', 'patients at high-risk of DFU']","['intervention (IG) or control groups (CG', 'intelligent insole system, consisting of pressure-sensing insoles and digital watch', 'personalised digital feedback']","['High-pressure parameters', 'number of bouts of high-pressure', 'high-pressure bouts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",46.0,0.0381553,"RESULTS


CG experienced more high-pressure bouts over time than IG across all areas of the foot (P<0.05).","[{'ForeName': 'Katie E', 'Initials': 'KE', 'LastName': 'Chatwin', 'Affiliation': 'Musculoskeletal Science & Sports Medicine Research Centre, Department of Life Sciences, Faculty of Science & Engineering, Manchester Metropolitan University, Oxford Road, Manchester M1 5GD, UK. Electronic address: katie.chatwin@stu.mmu.ac.uk.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Abbott', 'Affiliation': 'Musculoskeletal Science & Sports Medicine Research Centre, Department of Life Sciences, Faculty of Science & Engineering, Manchester Metropolitan University, Oxford Road, Manchester M1 5GD, UK; Manchester Metropolitan University Institute of Sport, Manchester, UK.'}, {'ForeName': 'Satyan M', 'Initials': 'SM', 'LastName': 'Rajbhandari', 'Affiliation': 'Lancashire Teaching Hospitals NHS Foundation Trust, Diabetes Centre, UK.'}, {'ForeName': 'Prabhav N', 'Initials': 'PN', 'LastName': 'Reddy', 'Affiliation': 'Department of Medical Physics and Biomedical Engineering, University College London, London, UK.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Bowling', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester M13 9PL, UK.'}, {'ForeName': 'Andrew J M', 'Initials': 'AJM', 'LastName': 'Boulton', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester M13 9PL, UK; Diabetes Research Institute, University of Miami, 1450 N.W. 10th Avenue, Miami, FL 33136, USA.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Reeves', 'Affiliation': 'Musculoskeletal Science & Sports Medicine Research Centre, Department of Life Sciences, Faculty of Science & Engineering, Manchester Metropolitan University, Oxford Road, Manchester M1 5GD, UK; Manchester Metropolitan University Institute of Sport, Manchester, UK.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2021.109091']
1947,34655863,"Effect of 8 weeks of supervised overfeeding on eating attitudes and behaviors, eating disorder symptoms, and body image: Results from the PROOF and EAT studies.","The physiological and metabolic effects of experimental overfeeding have been extensively studied, yet only few studies have assessed overfeeding effects on eating behaviors and psychological constructs. We analyzed two 8-week overfeeding studies, the PROOF Study (N = 25; 16 males; 16 African American; 24.1 years; 25.1 kg/m 2 , inpatient) and the EAT Study (N = 35; 29 males; 20 White; 26.7 years; 25.5 kg/m 2 , free-living). In both studies, participants were overfed 40% above baseline (daily) energy requirements for eight weeks, consuming all meals under direct supervision. We assessed eating attitudes and behaviors, eating disorder symptoms, and body image via validated questionnaires and visual analog scales at baseline, week (W) 4, and W8, and at two (PROOF: W16-Post, W24-Post) and three (EAT: W12-Post, W20-Post, W32-Post) follow-up visits, respectively. Hunger, desire to eat, and food cravings (carbohydrates, total cravings) decreased during overfeeding in both studies (all Cohen's d effect sizes ≥0.3, all p ≤ .048). Depressive symptoms and fear of fatness increased in both studies (all Cohen's d ≥ 0.4, p ≤ .020), though they were still within normal limits (t-scores ~43-49). Body dissatisfaction increased in both studies during overfeeding (all Cohen's d ≥ 0.4, all p ≤ .044) and remained increased during follow-up (PROOF: W16-Post, Cohen's d = 0.9, p = .004; EAT: W12-Post and W20-Post, all Cohen's d ≥ 0.4, all p ≤ .037). Overfeeding was associated with some deleterious effects, though most returned to baseline during follow-up. However, increases in body dissatisfaction remained up to three months post-overfeeding, highlighting the need to address body image disturbance among people who experience weight gain, even if much of the gained weight is subsequently lost. TRIAL REGISTRATION: The PROOF Study (ClinicalTrials.gov Identifier NCT00565149); the EAT Study (ClinicalTrials.gov Identifier NCT01672632).",2021,"Body dissatisfaction increased in both studies during overfeeding (all Cohen's d ≥ 0.4, all p ≤ .044) and remained increased during follow-up (PROOF: W16-Post, Cohen's d = 0.9, p = .004; EAT:","['PROOF Study (N\xa0=\xa025; 16 males; 16 African American; 24.1\xa0years; 25.1\xa0kg/m 2 , inpatient) and the EAT Study (N\xa0=\xa035; 29 males; 20 White; 26.7\xa0years; 25.5\xa0kg/m 2 , free-living']","['EAT', 'supervised overfeeding']","['body dissatisfaction', 'Depressive symptoms and fear of fatness', 'Hunger, desire to eat, and food cravings (carbohydrates, total cravings', 'eating attitudes and behaviors, eating disorder symptoms, and body image', 'Body dissatisfaction', 'eating attitudes and behaviors, eating disorder symptoms, and body image via validated questionnaires and visual analog scales']","[{'cui': 'C0556981', 'cui_str': '% proof'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0727404,"Body dissatisfaction increased in both studies during overfeeding (all Cohen's d ≥ 0.4, all p ≤ .044) and remained increased during follow-up (PROOF: W16-Post, Cohen's d = 0.9, p = .004; EAT:","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Höchsmann', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Fearnbach', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Dorling', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA; Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life of Sciences, University of Glasgow, UK.'}, {'ForeName': 'Candice A', 'Initials': 'CA', 'LastName': 'Myers', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Dachuan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Tiffany M', 'Initials': 'TM', 'LastName': 'Stewart', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA. Electronic address: Corby.Martin@pbrc.edu.'}]",Eating behaviors,['10.1016/j.eatbeh.2021.101570']
1948,34655859,Do media portrayals and social consensus information impact anti-fat attitudes and support for anti-weight discrimination laws and policies?,"Although weight stigma and discrimination are associated with increased body dissatisfaction and eating disorder risk, reduced opportunities, and poorer well-being, there are few legal protections for such discrimination in the U.S. We addressed one barrier to enacting protective legislation - public attitudes toward anti-weight discrimination laws - by assessing the impact of media representations of fatness and information about peer attitudes. Using a 2 × 2 experimental design, participants (N = 525) completed baseline assessments of political conservatism and weight bias and were randomly assigned to view fat-negative or fat-positive media content that was ostensibly supported or not supported by their peers, followed by questionnaires assessing fat phobia and legislative attitudes. Two-way ANCOVAs controlling for baseline weight bias and political conservatism indicated a significant effect for media framing, with greater fat phobia and less support for anti-discrimination laws and policies among those who viewed the fat-negative frame; however, effects for ostensible peer support and interaction effects were not significant. These preliminary findings suggest that efforts to shift media rhetoric may enhance support for anti-weight discrimination laws. Future research should investigate other barriers to anti-discrimination legislation and estimate their impact on body dissatisfaction, eating disorder risk, and other indicators of population health.",2021,"Although weight stigma and discrimination are associated with increased body dissatisfaction and eating disorder risk, reduced opportunities, and poorer well-being, there are few legal protections for such discrimination in the U.S.",['participants (N\xa0=\xa0525) completed baseline assessments of political conservatism and weight bias'],"['view fat-negative or fat-positive media content that was ostensibly supported or not supported by their peers, followed by questionnaires assessing fat phobia and legislative attitudes']",[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009800', 'cui_str': 'Conservatism'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",[],525.0,0.0304405,"Although weight stigma and discrimination are associated with increased body dissatisfaction and eating disorder risk, reduced opportunities, and poorer well-being, there are few legal protections for such discrimination in the U.S.","[{'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Ambwani', 'Affiliation': 'Department of Psychology, Dickinson College, United States. Electronic address: ambwanis@dickinson.edu.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Elder', 'Affiliation': 'Department of Psychology, Dickinson College, United States.'}, {'ForeName': 'Richanne', 'Initials': 'R', 'LastName': 'Sniezek', 'Affiliation': 'Department of Psychology, Dickinson College, United States.'}, {'ForeName': 'Mary Taylor', 'Initials': 'MT', 'LastName': 'Goeltz', 'Affiliation': 'Department of Psychology, Dickinson College, United States.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Beccia', 'Affiliation': 'Clinical and Population Health Research Program, Graduate School of Biomedical Sciences, University of Massachusetts Medical School, United States; Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, United States.'}]",Body image,['10.1016/j.bodyim.2021.09.005']
1949,34655839,"Encorafenib, binimetinib plus pembrolizumab triplet therapy in patients with advanced BRAF V600  mutant melanoma: safety and tolerability results from the phase I IMMU-TARGET trial.","BACKGROUND


Combination of immune checkpoint inhibitors and mitogen-activated protein kinase (MAPK) pathway inhibitors (MAPKi) has been proposed to enhance the durability of anti-tumour responses induced by MAPKi. Here, we present phase I safety results from an open-label, phase I/II study of pembrolizumab (PEM), encorafenib (ENC) and binimetinib (BIN) triplet therapy in advanced, B-Raf proto-oncogene serine/threonine kinase (BRAF) V600 -mutated melanoma (IMMU-TARGET, NCT02902042).
METHODS


The dose finding phase I part used a 3 + 3 design, starting with the approved doses of PEM (200 mg every three weeks), ENC (450 mg once daily [QD]) and BIN (45 mg twice daily [BID]) as dose level (DL) 0. Reduction of the ENC and BIN doses (300 mg QD and 30 mg BID at DL-1 and 200 mg QD and 30 mg BID at DL-2) was preplanned in case of ≥2 dose-limiting toxicities (DLTs). Primary objectives were to estimate the recommended phase II dose of the triplet combination, DLT and safety. As per the sponsor's decision, the study was terminated after the phase I part, as the clinical efficacy of the combination is currently being investigated in a pivotal, placebo-controlled (PEM mono), double-blinded phase III trial (STARBOARD,NCT04657991).
RESULTS


Fifteen patients were enrolled. DLTs of DL0 were creatine phosphokinase (CPK) elevation plus cytokine release syndrome (n = 1) and gamma glutamyl transferase (GGT) increase (n = 1). No DLT was observed in further 3 + 3 patients at DL-1. One (isolated GGT elevations) DLT of DL0 was questionable, as the patient had further episodes of isolated GGT elevations after treatment discontinuation. Hence, further 6 patients were enrolled at DL0: here, no DLT occurred. In total, 13 of 15 patients (87%) experienced a treatment-related adverse event (TRAE) and 8 patients (53%), a grade ≥III TRAE; there were no TRAE-related deaths. Increases in aspartate aminotransferases, GGT (6/15 patients) and CPK elevations (4/15) were the most common grade III-IV TRAE. In median, patients received triplet therapy for 24 weeks (interquartile range [IQR], 12-45). Of the 14 patients evaluable for efficacy, the overall response rate was 64% (95% confidence interval [CI], 35-87). At a median follow-up of 25 months (IQR, 9-28), progression-free survival at 12 months was 41% (95% CI, 13-68).
CONCLUSIONS


Triplet therapy with PEM, ENC and BIN as used in the study was feasible and safe and led to clinically meaningful disease control.",2021,"Increases in aspartate aminotransferases, GGT (6/15 patients) and CPK elevations (4/15) were the most common grade III-IV TRAE.","['patients with advanced BRAF V600  mutant melanoma', 'Fifteen patients were enrolled', '6 patients were enrolled at DL0']","['immune checkpoint inhibitors and mitogen-activated protein kinase (MAPK) pathway inhibitors (MAPKi', 'Encorafenib, binimetinib plus pembrolizumab triplet therapy', 'pembrolizumab (PEM), encorafenib (ENC) and binimetinib (BIN) triplet therapy', 'PEM', 'ENC']","['creatine phosphokinase (CPK) elevation plus cytokine release syndrome (n\xa0=\xa01)\xa0and gamma glutamyl transferase (GGT) increase', 'overall response rate', 'progression-free survival', 'recommended phase II dose\xa0of the triplet combination, DLT and safety', 'CPK elevations', 'treatment-related adverse event (TRAE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0104940', 'cui_str': 'Proto-Oncogene Protein B-raf'}, {'cui': 'C0033713', 'cui_str': 'Proto-oncogene'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C0072402', 'cui_str': 'Protein-Serine-Threonine Kinase'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}, {'cui': 'C4079208', 'cui_str': 'encorafenib'}, {'cui': 'C3899947', 'cui_str': 'Binimetinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0948245', 'cui_str': 'Cytokine release syndrome'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",15.0,0.153149,"Increases in aspartate aminotransferases, GGT (6/15 patients) and CPK elevations (4/15) were the most common grade III-IV TRAE.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zimmer', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), Partner Site Essen, Germany. Electronic address: lisa.zimmer@uk-essen.de.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Livingstone', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), Partner Site Essen, Germany. Electronic address: elisabeth.livingstone@uk-essen.de.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Krackhardt', 'Affiliation': 'Technische Universität München, School of Medicine, Klinik und Poliklinik Für Innere Medizin III, Klinikum Rechts der Isar, Ismaningerstr. 22, Munich 81675, Germany; German Cancer Consortium (DKTK), Technische Universität München, Partner Site Munich, Germany. Electronic address: angela.krackhardt@tum.de.'}, {'ForeName': 'Erwin S', 'Initials': 'ES', 'LastName': 'Schultz', 'Affiliation': 'Department of Dermatology, University Hospital of the Paracelsus Medical Private University, Nuremberg, Germany. Electronic address: erwin.schultz@klinikum-nuernberg.de.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Göppner', 'Affiliation': 'Clinic for Dermatology and Allergology, Justus-Liebig-University, Gießen, Germany. Electronic address: Daniela.Goeppner@derma.med.uni-giessen.de.'}, {'ForeName': 'Chalid', 'Initials': 'C', 'LastName': 'Assaf', 'Affiliation': 'Department of Dermatology, Helios-Klinikum Krefeld, Germany. Electronic address: chalid.assaf@helios-kliniken.de.'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Trebing', 'Affiliation': 'Department of Dermatology, Venereology, Allergology and Immunology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany. Electronic address: dietrich.trebing@klinikum-dessau.de.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Stelter', 'Affiliation': 'Department of Biostatistics, Alcedis GmbH, Giessen, Germany. Electronic address: kst@alcedis.de.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Windemuth-Kieselbach', 'Affiliation': 'Department of Biostatistics, Alcedis GmbH, Giessen, Germany. Electronic address: cwk@alcedis.de.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Ugurel', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), Partner Site Essen, Germany. Electronic address: selma.ugurel@uk-essen.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), Partner Site Essen, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.09.011']
1950,34655838,"A phase 2 randomized clinical trial of abiraterone plus ADT, apalutamide, or abiraterone and apalutamide in patients with advanced prostate cancer with non-castrate testosterone levels (LACOG 0415).","BACKGROUND


Androgen deprivation therapy (ADT) combined with apalutamide, abiraterone acetate plus prednisone, enzalutamide, or docetaxel are the standard treatments for advanced castration-sensitive prostate cancer (CSPC). We investigated ADT-free alternatives for advanced CSPC.
PATIENTS AND METHODS


LACOG 0415 is a phase 2, open-label, non-comparative, randomized trial. Patients with advanced CSPC were randomized (1:1:1) to receive goserelin plus abiraterone acetate and prednisone (ADT plus AAP arm), apalutamide (APA arm), or apalutamide plus abiraterone acetate and prednisone (APA plus AAP arm). The primary endpoint was the proportion of patients with PSA of ≤0.2 ng/mL at week 25 in the modified intention-to-treat population. Safety analyses were performed in all patients with at least one dose of the study drug.
RESULTS


Of 128 randomized patients, 120 patients were evaluable for PSA response at week 25; 17.2% had a high-risk biochemical recurrence, 8.6% had locally advanced disease, and 74.2% had distant metastases. At week 25, PSA of ≤0.2 ng/mL was observed in 75.6% (95%CI 59.7%-87.6%), 60.0% (95%CI 43.3%-75.1%), and 79.5% (95%CI 63.5%-90.7%) of patients in ADT plus AAP, APA, and APA plus AAP arms, respectively. PSA decline of ≥80% was observed in 100%, 90.0%, and 97.4%, respectively. Grade 3-4 AEs were observed in 31.0%, 21.4% and 36.4%, respectively. Testosterone levels increased significantly in the APA arm and decreased significantly in ADT plus AAP and APA plus AAP arms.
CONCLUSIONS


ADT-free alternatives provide a high PSA response in advanced CSPC, although the APA arm did not reach the expected rate of PSA of ≤0.2 ng/mL at week 25. These results warrant further investigation of ADT-free treatments as alternatives in advanced CSPC.
SOURCE STUDY REGISTRATION


ClinicalTrials.govNCT02867020.",2021,"Testosterone levels increased significantly in the APA arm and decreased significantly in ADT plus AAP and APA plus AAP arms.
","['128 randomized patients', 'Patients with advanced CSPC', 'patients with advanced prostate cancer with non-castrate testosterone levels (LACOG 0415', 'advanced castration-sensitive prostate cancer (CSPC']","['abiraterone plus ADT, apalutamide, or abiraterone and apalutamide', 'goserelin plus abiraterone acetate and prednisone (ADT plus AAP arm), apalutamide (APA arm), or apalutamide plus abiraterone acetate and prednisone (APA plus AAP arm', 'Androgen deprivation therapy (ADT) combined with apalutamide, abiraterone acetate plus prednisone, enzalutamide, or docetaxel']","['Grade 3-4 AEs', 'PSA decline', 'proportion of patients with PSA', 'PSA response', 'Testosterone levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]","[{'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0051989', 'cui_str': 'antiarrhythmic peptide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0113523', 'cui_str': ""diadenosine 5',5''''-P1,P6-hexaphosphate""}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]",120.0,0.158274,"Testosterone levels increased significantly in the APA arm and decreased significantly in ADT plus AAP and APA plus AAP arms.
","[{'ForeName': 'Fernando C', 'Initials': 'FC', 'LastName': 'Maluf', 'Affiliation': 'Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Beneficência Portuguesa de São Paulo, São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo, Brazil. Electronic address: maluffc@uol.com.br.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Schutz', 'Affiliation': 'Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eduardo H', 'Initials': 'EH', 'LastName': 'Cronemberger', 'Affiliation': 'Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Centro Regional Integrado de Oncologia, Fortaleza, Brazil.'}, {'ForeName': 'Murilo de A', 'Initials': 'MA', 'LastName': 'Luz', 'Affiliation': 'Hospital Erasto Gaertner, Curitiba, Brazil.'}, {'ForeName': 'Suelen P S', 'Initials': 'SPS', 'LastName': 'Martins', 'Affiliation': 'Cepho-FMABC, Santo André, Brazil.'}, {'ForeName': 'David Q B', 'Initials': 'DQB', 'LastName': 'Muniz', 'Affiliation': 'Instituto do Câncer do Estado de São Paulo (ICESP), São Paulo, Brazil.'}, {'ForeName': 'Diogo A', 'Initials': 'DA', 'LastName': 'Bastos', 'Affiliation': 'Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Instituto do Câncer do Estado de São Paulo (ICESP), São Paulo, Brazil.'}, {'ForeName': 'Flavio M', 'Initials': 'FM', 'LastName': 'Cárcano', 'Affiliation': 'Hospital de Câncer de Barretos, Barretos, Brazil.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Smaletz', 'Affiliation': 'Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Soares', 'Affiliation': 'Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Hospital Israelita Albert Einstein, São Paulo, Brazil; Centro Paulista de Oncologia - Oncoclinicas, São Paulo, Brazil.'}, {'ForeName': 'Fábio A', 'Initials': 'FA', 'LastName': 'Peixoto', 'Affiliation': 'Instituto COI de Educação, Pesquisa e Gestão em Saúde, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Gomes', 'Affiliation': 'Liga Norte Riograndense Contra o Câncer, Natal, Brazil.'}, {'ForeName': 'Felipe M', 'Initials': 'FM', 'LastName': 'Cruz', 'Affiliation': 'IBCC Oncologia - Centro Universitário São Camilo, São Paulo, Brazil.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Franke', 'Affiliation': 'Oncosite - Centro de Pesquisa Clínica, Ijuí, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Herchenhorn', 'Affiliation': ""Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Oncologia D'OR/Instituto D'OR de Ensino e Pesquisa, Rio de Janeiro, Brazil.""}, {'ForeName': 'Telma M', 'Initials': 'TM', 'LastName': 'Dos Santos', 'Affiliation': 'Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Vanessa de C', 'Initials': 'VC', 'LastName': 'Fabricio', 'Affiliation': 'Janssen Pharmaceuticals, Argentina.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Gidekel', 'Affiliation': 'Janssen Pharmaceuticals, Argentina.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Werutsky', 'Affiliation': 'Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Rafaela G', 'Initials': 'RG', 'LastName': 'de Jesus', 'Affiliation': 'Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Vinicius C', 'Initials': 'VC', 'LastName': 'Souza', 'Affiliation': ""Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Oncologia D'OR, Salvador, Brazil.""}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'Fay', 'Affiliation': 'Latin American Cooperative Oncology Group, Porto Alegre, Brazil; PUCRS School of Medicine, Porto Alegre, Brazil; Grupo Oncoclínicas, Porto Alegre, Brazil.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.08.032']
1951,34648533,Intracluster correlation coefficients in a large cluster randomized vaccine trial in schools: Transmission and impact of shared characteristics.,"Cluster randomized trials (cRCT) to assess vaccine effectiveness incorporate indirect effects of vaccination, helping to inform vaccination policy. To calculate the sample size for a cRCT, an estimate of the intracluster correlation coefficient (ICC) is required. For infectious diseases, shared characteristics and social mixing behaviours may increase susceptibility and exposure, promote transmission and be a source of clustering. We present ICCs from a school-based cRCT assessing the effectiveness of a meningococcal B vaccine (Bexsero, GlaxoSmithKline) on reducing oropharyngeal carriage of Neisseria meningitidis (Nm) in 34,489 adolescents from 237 schools in South Australia in 2017/2018. We also explore the contribution of shared behaviours and characteristics to these ICCs. The ICC for carriage of disease-causing Nm genogroups (primary outcome) pre-vaccination was 0.004 (95% CI: 0.002, 0.007) and for all Nm was 0.007 (95%CI: 0.004, 0.011). Adjustment for social behaviours and personal characteristics reduced the ICC for carriage of disease-causing and all Nm genogroups by 25% (to 0.003) and 43% (to 0.004), respectively. ICCs are also reported for risk factors here, which may be outcomes in future research. Higher ICCs were observed for susceptibility and/or exposure variables related to Nm carriage (having a cold, spending ≥1 night out socializing or kissing ≥1 person in the previous week). In metropolitan areas, nights out socializing was a highly correlated behaviour. By contrast, smoking was a highly correlated behaviour in rural areas. A practical example to inform future cRCT sample size estimates is provided.",2021,"Adjustment for social behaviours and personal characteristics reduced the ICC for carriage of disease-causing and all Nm genogroups by 25% (to 0.003) and 43% (to 0.004), respectively.","['34,489 adolescents from 237 schools in South Australia in 2017/2018']","['meningococcal B vaccine (Bexsero, GlaxoSmithKline']",['oropharyngeal carriage of Neisseria meningitidis'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}]","[{'cui': 'C3859491', 'cui_str': 'meningococcal group B vaccine'}, {'cui': 'C3853911', 'cui_str': 'Bexsero'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0027571', 'cui_str': 'Neisseria'}]",34489.0,0.115119,"Adjustment for social behaviours and personal characteristics reduced the ICC for carriage of disease-causing and all Nm genogroups by 25% (to 0.003) and 43% (to 0.004), respectively.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Whelan', 'Affiliation': 'Clinical and Epidemiology Research and Development, GlaxoSmithKline Vaccines B.V., Amsterdam, The Netherlands.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Marshall', 'Affiliation': ""Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, South Australia, Australia.""}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Sullivan', 'Affiliation': 'SAHMRI Women & Kids, South Australian Health & Medical Research Institute, Adelaide, Australia.'}]",PloS one,['10.1371/journal.pone.0254330']
1952,34655316,"Analgesic effect of oral ibuprofen 400, 600, and 800 mg; paracetamol 500 and 1000 mg; and paracetamol 1000 mg plus 60 mg codeine in acute postoperative pain: a single-dose, randomized, placebo-controlled, and double-blind study.","PURPOSE


Effect size estimates of analgesic drugs can be misleading. Ibuprofen (400 mg, 600 mg, 800 mg), paracetamol (1000 mg, 500 mg), paracetamol 1000 mg/codeine 60 mg, and placebo were investigated to establish the multidimensional pharmacodynamic profiles of each drug on acute pain with calculated effect size estimates.
METHODS


A randomized, double-blind, single-dose, placebo-controlled, parallel-group, single-centre, outpatient, and single-dose study used 350 patients (mean age 25 year, range 18 to 30 years) of homogenous ethnicity after third molar surgery. Primary outcome was sum pain intensity over 6 h. Secondary outcomes were time to analgesic onset, duration of analgesia, time to rescue drug intake, number of patients taking rescue drug, sum pain intensity difference, maximum pain intensity difference, time to maximum pain intensity difference, number needed to treat values, adverse effects, overall drug assessment as patient-reported outcome measure (PROM), and the effect size estimates NNT and NNTp.
RESULTS


Ibuprofen doses above 400 mg do not significantly increase analgesic effect. Paracetamol has a very flat analgesic dose-response profile. Paracetamol 1000/codeine 60 mg gives similar analgesia as ibuprofen from 400 mg, but has a shorter time to analgesic onset. Active drugs show no significant difference in maximal analgesic effect. Other secondary outcomes support these findings. The frequencies of adverse effects were low, mild to moderate in all active groups. NNT and NTTp values did not coincide well with PROMs.
CONCLUSION


Ibuprofen doses above 400 mg for acute pain offer limited analgesic gain. Paracetamol 1000 mg/codeine 60 mg is comparable to ibuprofen doses from 400 mg. Calculated effect size estimates and PROM in our study seem not to relate well as clinical analgesic efficacy estimators.
TRIAL REGISTRATION


NCT00699114.",2021,"The frequencies of adverse effects were low, mild to moderate in all active groups.","['350 patients (mean age 25\xa0year, range 18 to 30\xa0years) of homogenous ethnicity after third molar surgery', 'acute postoperative pain']","['oral ibuprofen', 'Paracetamol 1000/codeine', 'paracetamol', 'ibuprofen', 'Paracetamol', 'Paracetamol 1000', 'Ibuprofen', 'paracetamol 1000\xa0mg plus 60\xa0mg codeine', 'codeine', 'placebo', 'paracetamol 1000']","['time to analgesic onset, duration of analgesia, time to rescue drug intake, number of patients taking rescue drug, sum pain intensity difference, maximum pain intensity difference, time to maximum pain intensity difference, number needed to treat values, adverse effects, overall drug assessment as patient-reported outcome measure (PROM), and the effect size estimates NNT and NNTp', 'maximal analgesic effect', 'frequencies of adverse effects', 'sum pain intensity', 'analgesic effect', 'Analgesic effect']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009214', 'cui_str': 'Codeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.347118,"The frequencies of adverse effects were low, mild to moderate in all active groups.","[{'ForeName': 'Gaute', 'Initials': 'G', 'LastName': 'Lyngstad', 'Affiliation': 'Section of Dental Pharmacology and Pharmacotherapy, Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo, Blindern, P. O. Box 1119, N-0317, Nydalen, Oslo, Norway. gaute.lyngstad@odont.uio.no.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Skjelbred', 'Affiliation': 'Department of Maxillofacial Surgery, Oslo University Hospital, P. O. Box 4950, Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Swanson', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Blindern, P.O. Box 1122, N-0317, Oslo, Norway.'}, {'ForeName': 'Lasse A', 'Initials': 'LA', 'LastName': 'Skoglund', 'Affiliation': 'Section of Dental Pharmacology and Pharmacotherapy, Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo, Blindern, P. O. Box 1119, N-0317, Nydalen, Oslo, Norway.'}]",European journal of clinical pharmacology,['10.1007/s00228-021-03231-9']
1953,34653905,A two-week running intervention reduces symptoms related to depression and increases hippocampal volume in young adults.,"This study examined the effects of a two-week running intervention on depressive symptoms and structural changes of different subfields of the hippocampus in young adults from the general population. The intervention was realized in small groups of participants in a mostly forested area and was organized into seven units of about 60 min each. The study design included two intervention groups which were tested at three time points and which received the intervention time-delayed: The first group between the first and the second time point, and the second group between the second and the third time point (waiting control group). At each test session, magnetic resonance imaging (MRI) was performed and symptoms related to depression were measured by means of the Center for Epidemiological Studies Depression (CES-D) Scale. Results revealed a significant reduction of CES-D scores after the running intervention. The intervention also resulted in significant increases in the volume of the hippocampus, and reductions of CES-D scores right after the intervention were associated with increases in hippocampal volume. These findings add important new evidence on the beneficial role of aerobic exercise on depressive symptoms and related structural alterations of the hippocampus.",2021,"The intervention also resulted in significant increases in the volume of the hippocampus, and reductions of CES-D scores right after the intervention were associated with increases in hippocampal volume.","['young adults from the general population', 'young adults']","['magnetic resonance imaging (MRI', 'two-week running intervention', 'aerobic exercise']","['CES-D scores', 'volume of the hippocampus, and reductions of CES-D scores right', 'hippocampal volume', 'depressive symptoms and structural changes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0302015,"The intervention also resulted in significant increases in the volume of the hippocampus, and reductions of CES-D scores right after the intervention were associated with increases in hippocampal volume.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fink', 'Affiliation': 'Institute of Psychology, University of Graz, Austria. Electronic address: andreas.fink@uni-graz.at.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Koschutnig', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zussner', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}, {'ForeName': 'Corinna M', 'Initials': 'CM', 'LastName': 'Perchtold-Stefan', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rominger', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Benedek', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Papousek', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}]",Cortex; a journal devoted to the study of the nervous system and behavior,['10.1016/j.cortex.2021.08.010']
1954,34653878,Passive stiffness changes in the lumbar spine following simulated automotive low speed rear-end collisions.,"BACKGROUND


Historically, there has been a lack of focus on the lumbar spine during rear impacts because of the perception that the automotive seat back should protect the lumbar spine from injury. As a result, there have been no studies involving human volunteers to address the risk of low back injury in low velocity rear impact collisions.
METHODS


A custom-built crash sled was used to simulate rear impact collisions. Randomized collisions were completed with and without lumbar support. Measures of passive stiffness were obtained prior to impact (Pre), immediately post impact (Post) and 24 h post impact (Post-24). Low back pain reporting was monitored for 24 h following impact exposure.
FINDINGS


None of the participants developed clinically significant levels of low back pain after impact. Changes in the passive responses persisted after impact for the length of the low stiffness flexion and extension zone. The length of the low stiffness zone was longer in the Post and Post-24 trial for low stiffness flexion and longer in the Post-24 for low stiffness extension.
INTERPRETATION


Findings from this investigation demonstrate that during a laboratory-simulation of an 8 km/h rear-impact collision, young healthy adults did not develop low back pain. Changes in the low stiffness zone of the passive flexion/extension curves were observed following impact and persisted for 24 h. Changes in passive stiffness may lead to changes in the loads and load distributions during movement within the passive structures such as the ligaments and intervertebral discs following impacts.",2021,"The length of the low stiffness zone was longer in the Post and Post-24 trial for low stiffness flexion and longer in the Post-24 for low stiffness extension.
",[],[],"['low back pain', 'Low back pain reporting', 'passive stiffness']",[],[],"[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",,0.0918398,"The length of the low stiffness zone was longer in the Post and Post-24 trial for low stiffness flexion and longer in the Post-24 for low stiffness extension.
","[{'ForeName': 'Kayla M', 'Initials': 'KM', 'LastName': 'Fewster', 'Affiliation': 'Department of Kinesiology and Health Sciences, Faculty of Health, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Barrett', 'Affiliation': 'Department of Kinesiology and Health Sciences, Faculty of Health, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Jack P', 'Initials': 'JP', 'LastName': 'Callaghan', 'Affiliation': 'Department of Kinesiology and Health Sciences, Faculty of Health, University of Waterloo, Waterloo, ON, Canada. Electronic address: jack.callaghan@uwaterloo.ca.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2021.105507']
1955,34653814,"Differential expression of innate/adaptive immunity genes induced by endometrial scratching as a hopeful approach for implantation boosting in unexplained, repeated implantation failure: An RCT.","BACKGROUND


Endometrial scratching (ES) has been proposed as a potential treatment for implantation improvement in unexplained repeated implantation failure (uRIF) patients, however, little is known about its exact molecular mechanisms.
OBJECTIVE


This randomized controlled trial (RCT) was conducted on twenty uRIF patients to investigate the expression of innate and adaptive immune signaling genes after ES.
METHODS


Ten uRIF patients in the intervention (twice endometrial sampling in follicular and luteal phases) and 10 uRIF patients in the control group (only luteal phase sampling) were randomly enrolled. Gene expression analysis with innate and adaptive immune response PCR-array kit between intervention and control groups were performed.
RESULTS


Among innate immune-associated genes, a significant decrease was observed in the expression of APCS, CPR, CCL2, NLRP3, HLA-A, TLR3 and TLR4 in the intervention group. In adaptive immune-related genes, the expression level of CD80, CD86, CXCR3, IFNγ, IFNα1, IFNβ, MBL2, CCR6, CCR8 and IL17A were decreased and CSF2, GATA3, and IL4 increased significantly in the intervention group (P < 0.05). Of 14 uRIF patients, five live birth (35.71 %) was achieved.
CONCLUSION


ES in uRIF patients may exert positive effects on the endometrial preparation which increases its receptivity for embryo implantation by modulating the expression of an array of immune signaling pathway genes.",2021,"Among innate immune-associated genes, a significant decrease was observed in the expression of APCS, CPR, CCL2, NLRP3, HLA-A, TLR3 and TLR4 in the intervention group.","['twenty uRIF patients', 'Ten uRIF patients in the intervention (twice endometrial sampling in follicular and luteal phases) and 10 uRIF patients in the control group (only luteal phase sampling) were randomly enrolled', 'unexplained repeated implantation failure (uRIF) patients', 'uRIF patients']",['Endometrial scratching (ES'],"['expression of APCS, CPR, CCL2, NLRP3, HLA-A, TLR3 and TLR4', 'expression level of CD80, CD86, CXCR3, IFNγ, IFNα1, IFNβ, MBL2, CCR6, CCR8 and IL17A were decreased and CSF2, GATA3, and IL4', 'five live birth']","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C1449159', 'cui_str': 'CCL2 protein, human'}, {'cui': 'C0019728', 'cui_str': 'HLA-A antigen'}, {'cui': 'C1313494', 'cui_str': 'TLR3 protein, human'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0104998', 'cui_str': 'Lymphocyte antigen CD80'}, {'cui': 'C0527903', 'cui_str': 'Lymphocyte antigen CD86'}, {'cui': 'C1741914', 'cui_str': 'CXCR3 protein, human'}, {'cui': 'C1308121', 'cui_str': 'CCR6 protein, human'}, {'cui': 'C1307911', 'cui_str': 'CCR8 protein, human'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C1307598', 'cui_str': 'GATA3 protein, human'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",20.0,0.0486916,"Among innate immune-associated genes, a significant decrease was observed in the expression of APCS, CPR, CCL2, NLRP3, HLA-A, TLR3 and TLR4 in the intervention group.","[{'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Aghajanpour', 'Affiliation': 'Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran; Department of Anatomical Sciences, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Hosseini', 'Affiliation': 'Department of Obstetrics and Gynecology, IVF Clinic, Mousavi Hospital, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran; Zanjan Metabolic Diseases Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Amirchaghmaghi', 'Affiliation': 'Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Zandieh', 'Affiliation': 'Department of Anatomical Sciences, School of Medicine, Iran University of Medical Sciences, Tehran, Iran; Shahid Akbarabadi Clinical Research Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Fatemehsadat', 'Initials': 'F', 'LastName': 'Amjadi', 'Affiliation': 'Department of Anatomical Sciences, School of Medicine, Iran University of Medical Sciences, Tehran, Iran; Shahid Akbarabadi Clinical Research Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Yahyaei', 'Affiliation': 'Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Zolfaghari', 'Affiliation': 'Department of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Aflatoonian', 'Affiliation': 'School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Ashrafi', 'Affiliation': 'Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran; Obstetrics and Gynecology Department, School of Medicine, Iran University of Medical Science, Tehran, Iran. Electronic address: Dr.mahnaz.ashrafi@gmail.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Aflatoonian', 'Affiliation': 'Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran. Electronic address: R.Aflatoonian@gmail.com.'}]",Journal of reproductive immunology,['10.1016/j.jri.2021.103426']
1956,34653740,Intermittent theta burst stimulation of cerebellar vermis enhances fronto-cerebellar resting state functional connectivity in schizophrenia with predominant negative symptoms: A randomized controlled trial.,"OBJECTIVE


Negative symptoms of schizophrenia are substantially disabling and treatment resistant. Novel treatments like repetitive transcranial magnetic stimulation (TMS) need to be examined for the same using the experimental medicine approach that incorporates tests of mechanism of action in addition to clinical efficacy in trials.
METHODS


Study was a double-blind, parallel, randomized, sham-controlled trial recruiting schizophrenia with at least a moderate severity of negative symptoms. Participants were randomized to real or sham intermittent theta burst stimulation (iTBS) under MRI-guided neuro-navigation, targeting the cerebellar vermis area VII-B, at a stimulus intensity of 100% active motor threshold, two sessions/day for five days (total = 6000 pulses). Assessments were conducted at baseline (T0), day-6 (T1) and week-6 (T2) after initiation of intervention. Main outcomes were, a) Scale for the Assessment of Negative Symptoms (SANS) score (T0, T1, T2), b) fronto-cerebellar resting state functional connectivity (RSFC) (T0, T1).
RESULTS


Thirty participants were recruited in each arm. Negative symptoms improved in both arms (p < 0.001) but was not significantly different between the two arms (p = 0.602). RSFC significantly increased between the cerebellar vermis and the right inferior frontal gyrus (p cluster-FWER  = 0.033), right pallidum (p cluster-FWER  = 0.042) and right frontal pole (p cluster-FWER  = 0.047) in the real arm with no change in the sham arm.
CONCLUSION


Cerebellar vermal iTBS engaged a target belonging to the class of cerebello-subcortical-cortical networks, implicated in negative symptoms of schizophrenia. However, this did not translate to a superior clinical efficacy. Future trials should employ enhanced midline cerebellar TMS stimulation parameters for longer durations that can potentiate and translate biological changes into clinical effects.",2021,Negative symptoms improved in both arms (p < 0.001) but was not significantly different between the two arms (p = 0.602).,"['schizophrenia with predominant negative symptoms', 'schizophrenia with at least a moderate severity of negative symptoms', 'Thirty participants were recruited in each arm']","['repetitive transcranial magnetic stimulation (TMS', 'Intermittent theta burst stimulation of cerebellar vermis enhances fronto-cerebellar resting state functional connectivity', 'real or sham intermittent theta burst stimulation (iTBS) under MRI-guided neuro-navigation']","['right pallidum', 'Negative symptoms', 'a) Scale for the Assessment of Negative Symptoms (SANS) score (T0, T1, T2), b) fronto-cerebellar resting state functional connectivity (RSFC', 'right frontal pole', 'RSFC']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0228482', 'cui_str': 'Cerebellar vermis structure'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0017651', 'cui_str': 'Globus pallidus structure'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0149546', 'cui_str': 'Structure of frontal pole'}]",30.0,0.2083,Negative symptoms improved in both arms (p < 0.001) but was not significantly different between the two arms (p = 0.602).,"[{'ForeName': 'Rakshathi', 'Initials': 'R', 'LastName': 'Basavaraju', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, Karnataka, India.'}, {'ForeName': 'Dhruva', 'Initials': 'D', 'LastName': 'Ithal', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, Karnataka, India.'}, {'ForeName': 'Milind Vijay', 'Initials': 'MV', 'LastName': 'Thanki', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, Karnataka, India.'}, {'ForeName': 'Arvinda Hanumanthapura', 'Initials': 'AH', 'LastName': 'Ramalingaiah', 'Affiliation': 'Department of Neuro Imaging and Interventional Radiology, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, Karnataka, India.'}, {'ForeName': 'Jagadisha', 'Initials': 'J', 'LastName': 'Thirthalli', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, Karnataka, India.'}, {'ForeName': 'Rajakumari P', 'Initials': 'RP', 'LastName': 'Reddy', 'Affiliation': 'Department of Clinical Psychology, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, Karnataka, India.'}, {'ForeName': 'Roscoe O', 'Initials': 'RO', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA. Electronic address: robrady@bidmc.harvard.edu.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Halko', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA. Electronic address: MHALKO@mclean.harvard.edu.'}, {'ForeName': 'Nicolas R', 'Initials': 'NR', 'LastName': 'Bolo', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA. Electronic address: nbolo@bidmc.harvard.edu.'}, {'ForeName': 'Matcheri S', 'Initials': 'MS', 'LastName': 'Keshavan', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA. Electronic address: mkeshava@bidmc.harvard.edu.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pascual-Leone', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research and Center for Memory Health, Hebrew Senior Life, Boston, MA, USA; Department of Neurology, Harvard Medical School, Boston, MA, USA; Guttmann Brain Health Institut, Institut Guttmann, Universitat Autonoma Barcelona, Spain. Electronic address: apleone@hsl.harvard.edu.'}, {'ForeName': 'Urvakhsh Meherwan', 'Initials': 'UM', 'LastName': 'Mehta', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore 560029, Karnataka, India. Electronic address: urvakhsh@gmail.com.'}, {'ForeName': 'Muralidharan', 'Initials': 'M', 'LastName': 'Kesavan', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore 560029, Karnataka, India. Electronic address: drmuralidk@gmail.com.'}]",Schizophrenia research,['10.1016/j.schres.2021.10.005']
1957,34592390,Structured self-monitoring of blood glucose is associated with more appropriate therapeutic interventions than unstructured self-monitoring: A novel analysis of data from the PRISMA trial.,"AIMS


To investigate the relationship between single therapeutic interventions and indicatorsofglycemic control in the PRISMA trial, a large study comparing the effects of intensive structured SMBG (ISM) vs. active control (AC) in non-insulin-treated type 2 diabetes (T2D).
METHODS


Information was collected at four time points, corresponding to months 3, 6, 9, and 12 and visits 2, 3, 4, and 5, respectively. Data on therapeutic interventions, HbA 1c  levels and the number of hypoglycemic episodes at each visit were analyzed.
RESULTS


Intensification of drug therapy occurred in 20.3% vs. 15.6%, and no change in 71.8% vs. 78.7% of visits for the ISM and AC groups, respectively. On the other hand, de-intensification and redistribution of drugs and/or drug dose occurred in a similar proportion of visits. Intensification of drug therapy in both groups was associated with significant reductions in HbA 1c  vs. the previous visit, while de-intensification of therapy led to a significant increase in HbA 1c  in the AC group only.
CONCLUSIONS


Our data strongly support that structured SMBG has clinical value in reducing HbA 1c  in non-insulin-treated T2D and suggest that this clinical benefit may be mediated by more appropriate and timely changes in drug therapy.",2021,Our data strongly support that structured SMBG has clinical value in reducing HbA 1c  in non-insulin-treated T2D and suggest that this clinical benefit may be mediated by more appropriate and timely changes in drug therapy.,['non-insulin-treated type 2 diabetes (T2D'],['intensive structured SMBG (ISM) vs. active control (AC'],"['HbA 1c', 'HbA 1c  levels and the number of hypoglycemic episodes']","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}]",,0.0384653,Our data strongly support that structured SMBG has clinical value in reducing HbA 1c  in non-insulin-treated T2D and suggest that this clinical benefit may be mediated by more appropriate and timely changes in drug therapy.,"[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Di Molfetta', 'Affiliation': 'Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari School of Medicine, Bari, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bosi', 'Affiliation': 'Diabetes Research Institute, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ceriello', 'Affiliation': 'IRCCS MultiMedica, Milan, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Cucinotta', 'Affiliation': 'Department of Clinical and Experimental Medicine, Messina University, Messina, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tiengo', 'Affiliation': 'Emeritus Professor of Endocrinology, University of Padova, Padua, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Scavini', 'Affiliation': 'Diabetes Research Institute, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Piccolo', 'Affiliation': 'Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari School of Medicine, Bari, Italy.'}, {'ForeName': 'Erminio', 'Initials': 'E', 'LastName': 'Bonizzoni', 'Affiliation': 'Section of Medical Statistics and Biometry GA Maccacaro, Department of Clinical Science and Community, University of Milan, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Acmet', 'Affiliation': 'Medical Affair Director, Roche Diabetes Care Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giorgino', 'Affiliation': 'Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari School of Medicine, Bari, Italy. Electronic address: francesco.giorgino@uniba.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2021.109070']
1958,34653558,l-Glutamine supplementation enhances glutathione peroxidase and paraoxonase-1 activities in HDL of exercising older individuals.,"BACKGROUND


Oxidative stress is an important factor in the formation of atherosclerotic plaques. High-density lipoprotein (HDL) harbors paraoxonase-1 (PON-1) and glutathione peroxidase (GPx), key enzymes in the protection against the harmful effects of oxidative stress. Although exercise training can increase both HDL-c content and its antioxidant action, and glutamine (Gln) intake also promotes GPx-based defenses, the association between exercise training and Gln in the regulation of PON-1 activity was not explored. Therefore, the objective of this study was to investigate the effects of Gln supplementation on the redox balance and on the total HDL antioxidant capacity by evaluation of the activity of PON-1 and GPx enzymes in physically exercised elderly individuals compared to non-exercised ones.
METHODS


Fifty-one practitioners of a combined exercise training program (CET, age: 71.9 ± 5.7 years) and 32 non-practitioners (NP, age: 73 ± 6.3 years) participated in the study. CET and NP groups were separated into 2 subgroups according to the supplementation: Gln, 0.3 g/kg/day + 10 g maltodextrin (CET-Gln, n = 26; and NP-Gln, n = 16) or placebo, 10 g maltodextrin (CET-PL, n = 25; and NP-PL, n = 16). Blood samples were drawn at baseline and after 30 days after commencement of the supplementation for biochemical and enzyme activity analyses.
RESULTS


Increased HDL-c, total peroxidase (PRx), and GPx activities were found in both CET-Gln and NP-Gln after the supplementation period, compared to baseline, in opposition to CET-PL and NP-PL groups. PON-1 activity increased only in CET-Gln. In both CET-Gln and NP-Gln groups, there was a reduction of the total peroxides/PRx, iron/PRx, and total peroxides/GPX ratios after supplementation. In CET-Gln, thiobarbituric acid-reactive substances (TBARS)/PRx and TBARS/GPx ratios were also lower after supplementation. CET-Gln and CET-PL subgroups had lower glycemia than NP-Gln and NP-PL, either at baseline or after the supplementation periods. The other parameters were unchanged after supplementation [total cholesterol, LDL-c, triglycerides, non-HDL cholesterol, total peroxides, TBARS, iron serum, Trolox-equivalent antioxidant capacity (TEAC), and uric acid].
CONCLUSIONS


Gln supplementation can increase glutathione peroxidase activity regardless the individuals were physically active or sedentary, but the PON-1 activity only increased in physically active individuals. These results show the potential of Gln supplementation in the maintenance of the vascular redox balance, with potential implications for atherogenesis protection.",2021,"In both CET-Gln and NP-Gln groups, there was a reduction of the total peroxides/PRx, iron/PRx, and total peroxides/GPX ratios after supplementation.","['Fifty-one practitioners of a', 'physically exercised elderly individuals compared to non-exercised ones', 'HDL of exercising older individuals', 'CET, age: 71.9\u202f±\u202f5.7\u202fyears) and 32 non-practitioners (NP, age: 73\u202f±\u202f6.3\u202fyears) participated in the study']","['exercise training', 'CET', 'CET-Gln and CET-PL', 'maltodextrin (CET-Gln, n\u202f=\u202f26; and NP-Gln, n\u202f=\u202f16) or placebo, 10\u202fg maltodextrin', 'l-Glutamine supplementation', 'Gln supplementation', 'combined exercise training program']","['High-density lipoprotein (HDL) harbors paraoxonase-1', 'total peroxides/PRx, iron/PRx, and total peroxides/GPX ratios', 'PON-1 activity', 'supplementation [total cholesterol, LDL-c, triglycerides, non-HDL cholesterol, total peroxides, TBARS, iron serum, Trolox-equivalent antioxidant capacity (TEAC), and uric acid', 'HDL-c, total peroxidase (PRx), and GPx activities', 'HDL-c content and its antioxidant action, and glutamine (Gln) intake', 'glutathione peroxidase activity', 'glutathione peroxidase and paraoxonase-1 activities', 'thiobarbituric acid-reactive substances (TBARS)/PRx and TBARS/GPx ratios']","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C1121571', 'cui_str': 'Paraoxonase 1'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031180', 'cui_str': 'Peroxide'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0147003', 'cui_str': 'Trolox C'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0076442', 'cui_str': 'thiobarbituric acid'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}]",,0.141564,"In both CET-Gln and NP-Gln groups, there was a reduction of the total peroxides/PRx, iron/PRx, and total peroxides/GPX ratios after supplementation.","[{'ForeName': 'Renier S', 'Initials': 'RS', 'LastName': 'Pires', 'Affiliation': 'Post-Graduation Program in Health Sciences, Santo Amaro University (UNISA), São Paulo, SP 04829-300, Brazil.'}, {'ForeName': 'Pedro G S', 'Initials': 'PGS', 'LastName': 'Braga', 'Affiliation': 'Lipid Metabolism Laboratory, Heart Institute (InCor), Medical School Hospital, University of São Paulo, SP 05403-900, Brazil.'}, {'ForeName': 'Juliana M B', 'Initials': 'JMB', 'LastName': 'Santos', 'Affiliation': 'Post-Graduation Program in Science of Human and Rehabilitation, Federal University of São Paulo (UNIFESP), Santos, SP 11015-020, Brazil.'}, {'ForeName': 'Jônatas B', 'Initials': 'JB', 'LastName': 'Amaral', 'Affiliation': 'ENT Lab, Department of Otorhinolaryngology, Federal University of São Paulo (UNIFESP), São Paulo, SP 04025-002, Brazil.'}, {'ForeName': 'Gislene R', 'Initials': 'GR', 'LastName': 'Amirato', 'Affiliation': 'ENT Lab, Department of Otorhinolaryngology, Federal University of São Paulo (UNIFESP), São Paulo, SP 04025-002, Brazil.'}, {'ForeName': 'Caio S', 'Initials': 'CS', 'LastName': 'Trettel', 'Affiliation': 'Interdisciplinary Program in Health Sciences, Institute of Physical Activity Sciences and Sports (ICAFE), Cruzeiro do Sul University, São Paulo, SP 01506-000, Brazil.'}, {'ForeName': 'Carlos A F', 'Initials': 'CAF', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Medicine (Geriatrics and Gerontology), Federal University of São Paulo (UNIFESP), São Paulo, SP 04020-050, Brazil.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Vaisberg', 'Affiliation': 'ENT Lab, Department of Otorhinolaryngology, Federal University of São Paulo (UNIFESP), São Paulo, SP 04025-002, Brazil.'}, {'ForeName': 'Luis H S', 'Initials': 'LHS', 'LastName': 'Nali', 'Affiliation': 'Post-Graduation Program in Health Sciences, Santo Amaro University (UNISA), São Paulo, SP 04829-300, Brazil.'}, {'ForeName': 'Rodolfo P', 'Initials': 'RP', 'LastName': 'Vieira', 'Affiliation': 'Post-Graduation Program in Science of Human and Rehabilitation, Federal University of São Paulo (UNIFESP), Santos, SP 11015-020, Brazil; Post-graduation Program in Bioengineering and Biomedical Engineering, Universidade Brasil, São Paulo, SP 08230-030, Brazil; Brazilian Institute of Teaching and Research in Pulmonary and Exercise Immunology (IBEPIPE), São Jose dos Campos, SP 12245-520, Brazil.'}, {'ForeName': 'Raul C', 'Initials': 'RC', 'LastName': 'Maranhão', 'Affiliation': 'Lipid Metabolism Laboratory, Heart Institute (InCor), Medical School Hospital, University of São Paulo, SP 05403-900, Brazil.'}, {'ForeName': 'Tania C', 'Initials': 'TC', 'LastName': 'Pithon-Curi', 'Affiliation': 'Interdisciplinary Program in Health Sciences, Institute of Physical Activity Sciences and Sports (ICAFE), Cruzeiro do Sul University, São Paulo, SP 01506-000, Brazil.'}, {'ForeName': 'Marcelo P', 'Initials': 'MP', 'LastName': 'Barros', 'Affiliation': 'Interdisciplinary Program in Health Sciences, Institute of Physical Activity Sciences and Sports (ICAFE), Cruzeiro do Sul University, São Paulo, SP 01506-000, Brazil.'}, {'ForeName': 'André L L', 'Initials': 'ALL', 'LastName': 'Bachi', 'Affiliation': 'Post-Graduation Program in Health Sciences, Santo Amaro University (UNISA), São Paulo, SP 04829-300, Brazil; ENT Lab, Department of Otorhinolaryngology, Federal University of São Paulo (UNIFESP), São Paulo, SP 04025-002, Brazil; Brazilian Institute of Teaching and Research in Pulmonary and Exercise Immunology (IBEPIPE), São Jose dos Campos, SP 12245-520, Brazil. Electronic address: allbachi77@gmail.com.'}]",Experimental gerontology,['10.1016/j.exger.2021.111584']
1959,34653557,Short-term community-based exercise programs in low-income older women: Does exercise intensity and modality matters?,"Our aim was to evaluate the effect of community-based exercise program (CBEP) intensity and modality on anthropometric, hemodynamic, and functional capacity parameters in low-income older women. Forty insufficiently active older women (68.2 ± 7.9 years) were randomly assigned to perform 12 weeks of twice-weekly high-intensity interval training combined with resistance training (HIIT+RT/n = 12), moderate-intensity continuous training combined with resistance training (MICT+RT/n = 13), or resistance training alone (RT/n = 15). Anthropometric (body mass index and waist circumference), hemodynamic (blood pressure and heart rate), and functional capacity variables (flexibility, upper and lower limb muscle strength, and mobility) were assessed before and after training programs. Waist circumference reduced similarly after all CBEP (~3 to ~4 cm; P < 0.05). Tendency toward reduction in diastolic blood pressure (~4 mm Hg; P = 0.073), and improvements in flexibility (14.5%, P = 0.011) and handgrip strength (15.8%; P = 0.02) were found only in HIIT+RT. Indeed, only RT was effective to improve five-time sit to stand (14.1%; P = 0.013). No significant difference between groups was found during follow-up in any variable. The results of present study suggest that low-income older women may improve anthropometric, hemodynamic and functional capacity variables by participating in twice-weekly short-term (i.e.: 12 weeks) CBEP. However, the CBEP-effects on hemodynamic and functional capacity appears to be affected by exercise intensity (only HIIT+RT tended toward improving diastolic BP) and modality (only RT improved significantly five-time sit to stand), respectively.",2021,"Indeed, only RT was effective to improve five-time sit to stand (14.1%; P = 0.013).","['Forty insufficiently active older women (68.2\u202f±\u202f7.9\u202fyears', 'low-income older women']","['Short-term community-based exercise programs', 'community-based exercise program (CBEP) intensity and modality', 'twice-weekly high-intensity interval training combined with resistance training (HIIT+RT/n\u202f=\u202f12), moderate-intensity continuous training combined with resistance training (MICT+RT/n\u202f=\u202f13), or resistance training alone']","['diastolic BP', 'hemodynamic and functional capacity', 'flexibility', 'diastolic blood pressure', 'Waist circumference', 'anthropometric, hemodynamic and functional capacity variables', 'handgrip strength', 'Anthropometric (body mass index and waist circumference), hemodynamic (blood pressure and heart rate), and functional capacity variables (flexibility, upper and lower limb muscle strength, and mobility']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",40.0,0.00734094,"Indeed, only RT was effective to improve five-time sit to stand (14.1%; P = 0.013).","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Teixeira do Amaral', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Fernandes', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil.'}, {'ForeName': 'Awassi Yuphiwa', 'Initials': 'AY', 'LastName': 'Ngomane', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil.'}, {'ForeName': 'Isabela Roque', 'Initials': 'IR', 'LastName': 'Marçal', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil.'}, {'ForeName': 'Gabriel de Souza', 'Initials': 'GS', 'LastName': 'Zanini', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil.'}, {'ForeName': 'Emmanuel Gomes', 'Initials': 'EG', 'LastName': 'Ciolac', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil. Electronic address: emmanuel.ciolac@unesp.br.'}]",Experimental gerontology,['10.1016/j.exger.2021.111591']
1960,34653532,Effects of hemoencephalographic biofeedback with virtual reality on selected aspects of attention in children with ADHD.,"For children with attention deficit/hyperactivity disorder (ADHD), a reduction of inattention by biofeedback has been shown in several studies. As evidenced by previous reports, biofeedback (BFB) with virtual reality (VR) allows for controlling distractors, providing an environment that captures participants' attention. The purpose of this study was to evaluate the effects of hemoencephalographic (HEG) BFB with VR in treating deficits in vigilance (assessed using the short form of the Mackworth Clock Task), visual search (the Visual Search Task), and divided attention (Multitasking Test) among children with ADHD. Data subjected to analysis were collected from 87 participants aged 9-15 years. Children were assigned to one of three groups (standard 2D BFB in the lab, VR BFB with a limited visual scene, VR BFB with a complex visual scene) and were subjected to ten HEG BFB sessions. Children in the VR BFB groups exhibited a bigger regional cerebral blood oxygenation slope during BFB and better performance in cognitive tests following the experiment compared to children in the 2D BFB group. The data obtained suggest that HEG BFB with VR may have a more beneficial effect in treating attention deficits compared to standard 2D HEG BFB. We believe that the strong effects of HEG BFB with VR stem from the increased commitment and motivation in individuals, rather than from manipulation with regard to visual scene complexity.",2021,Children in the VR BFB groups exhibited a bigger regional cerebral blood oxygenation slope during BFB and better performance in cognitive tests following the experiment compared to children in the 2D BFB group.,"['children with ADHD', '87 participants aged 9-15\u202fyears', 'children with attention deficit/hyperactivity disorder (ADHD']","['hemoencephalographic (HEG) BFB with VR', 'hemoencephalographic biofeedback with virtual reality', 'VR BFB with a limited visual scene, VR BFB with a complex visual scene', 'biofeedback (BFB) with virtual reality (VR']",['bigger regional cerebral blood oxygenation slope'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",87.0,0.0411255,Children in the VR BFB groups exhibited a bigger regional cerebral blood oxygenation slope during BFB and better performance in cognitive tests following the experiment compared to children in the 2D BFB group.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Skalski', 'Affiliation': 'Polish Academy of Sciences, Institute of Psychology, Warsaw, Poland. Electronic address: sebastian.skalski@sd.psych.pan.pl.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Konaszewski', 'Affiliation': 'University of Białystok, Faculty of Education, Białystok, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Pochwatko', 'Affiliation': 'Polish Academy of Sciences, Institute of Psychology, Warsaw, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Balas', 'Affiliation': 'Polish Academy of Sciences, Institute of Psychology, Warsaw, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Surzykiewicz', 'Affiliation': 'Catholic University of Eichstaett-Ingolstadt, Faculty of Philosophy and Education, Eichstaett, Germany; Cardinal Stefan Wyszynski University in Warsaw, Faculty of Educational Sciences, Warsaw, Poland.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2021.10.001']
1961,34653526,Preoperative radiotherapy 5 × 5 Gy and short versus long interval between surgery for resectable rectal cancer: 10-Year follow-up of the randomised controlled trial.,"BACKGROUND


Studies on short-course preoperative radiotherapy in combination with total mesorectal excision for rectal cancer reported improved local control without clear survival benefits. The optimal fractionation and interval between radiotherapy and surgery are still under debate. We, therefore, aimed to report 10-year results of a randomized clinical trial (RCT, NCT01444495) comparing different time intervals between irradiation and surgery for rectal cancer.
MATERIAL AND METHODS


Data from the RCT conducted at a single academic centre were reviewed based on regular control visits with the median follow-up of 12 years. Patients with rectal cancer were randomly assigned to short-course preoperative radiotherapy (5 × 5 Gy) followed by surgery 7-10 days (short interval) or 4-5 weeks (long interval) after the end of irradiation. The primary endpoint was the local recurrence rate at 5 years. The secondary endpoints included overall survival, disease-free survival, systemic recurrence rate, and downstaging.
RESULTS


A total of 154 patients were randomly assigned to short (n = 77) or long interval (n = 77) surgery. The cumulative incidence of local recurrence at 10 years was 1.3% and 11.7% in the short and long-interval groups, respectively (p = 0.031). Accordingly, the incidence of systemic relapse was 14.3% versus 9.1% (p = 0.0319). There were no differences in the overall 10-year survival between patients subject to short and long-interval surgery (58% vs 61%, p = 0.754). However, patients with downstaging after radiotherapy had significantly better 10-year survival rates than non-responders.
CONCLUSIONS


Short-course preoperative radiotherapy with delayed surgery demonstrated an increased risk of local relapse over a 10-year follow-up.",2021,"Accordingly, the incidence of systemic relapse was 14.3% versus 9.1% (p=0.0319).","['Patients with rectal cancer', 'Data from the RCT conducted at a single academic centre were reviewed based on regular control visits with the median follow-up of 12 years', '154 patients were randomly assigned to short (n=77) or long interval (n=77) surgery', 'resectable rectal cancer']","['Preoperative radiotherapy 5×5 Gy and short versus long interval between surgery', 'total mesorectal excision', 'short-course preoperative radiotherapy', 'radiotherapy']","['overall survival, disease-free survival, systemic recurrence rate, and downstaging', 'local recurrence rate', 'incidence of systemic relapse', 'cumulative incidence of local recurrence', 'risk of local relapse', '10-year survival rates', 'overall 10-year survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",154.0,0.7378,"Accordingly, the incidence of systemic relapse was 14.3% versus 9.1% (p=0.0319).","[{'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Pach', 'Affiliation': 'First Department of Surgery, Jagiellonian University Medical College, Krakow, Poland. Electronic address: radoslaw.pach@uj.edu.pl.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Sierzega', 'Affiliation': 'First Department of Surgery, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Szczepanik', 'Affiliation': 'First Department of Surgery, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Popiela', 'Affiliation': 'First Department of Surgery, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Richter', 'Affiliation': 'First Department of Surgery, Jagiellonian University Medical College, Krakow, Poland.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.10.006']
1962,34655575,Impact of intermittent hypoxia on human vascular responses during sleep.,"Exposure to intermittent hypoxia (IH) ≥15 times per hour is believed to be the primary mechanism for the increased risk of cerebrovascular and cardiovascular disease in patients with moderate to severe sleep apnea. Human experimental models of IH used to investigate this link have been predominantly employed during wakefulness, which limits extrapolation of findings to sleep apnea where IH occurs during sleep. Moreover, how IH impacts vascular regulation during sleep has not been measured quantitatively. Therefore, the objective of this study was to assess the impact sleep accompanied by IH on vascular responses to hypoxia and hypercapnia during sleep. Ten males performed two randomly scheduled 6-h overnight sleep studies. One sleep study was performed in room air (normoxia) and the other sleep study was performed during isocapnic IH (60 s hypoxia-60 s normoxia). On each night, cerebrovascular (peak blood velocity through the middle cerebral artery (V¯ P ); transcranial Doppler ultrasound) and cardiovascular (blood pressure, heart rate) responses to hypoxia and hypercapnia were measured before sleep onset (PM-Awake), within the first 2 h of sleep (PM-Asleep), in the 5th (out of 6) hours of sleep (AM-Asleep) and after being awoken in the morning (AM-Awake). Sleep accompanied by IH had no impact on the V¯ P  and blood pressure responses to hypoxia and hypercapnic at any timepoint (p ≥ 0.103 for all responses). However, the AM-Awake heart rate response to hypoxia was greater following sleep in IH compared to sleep in normoxia. Independent of the sleep environment, the V¯ P  response to hypoxia and hypercapnia were reduced during sleep. In conclusion, cerebral blood flow responses are reduced during sleep compared to wakefulness, but 6 h of sleep accompanied by IH does not alter cerebrovascular and cardiovascular response to hypoxia and hypercapnia during wakefulness or sleep in healthy young humans. However, it is likely that longer exposure to IH during sleep (i.e., days-to-weeks) is required to better elucidate IH's impact on vascular regulation in humans.",2021,Sleep accompanied by IH had no impact on the V¯ P  and blood pressure responses to hypoxia and hypercapnic at any timepoint (p > 0.103 for all responses).,"['Ten males performed two randomly scheduled 6-h overnight sleep studies', 'human vascular responses during sleep', 'patients with moderate to severe sleep apnea', 'healthy young humans']",['intermittent hypoxia'],"['V¯ P  response to hypoxia and hypercapnia', 'night, cerebrovascular (peak blood velocity through the middle cerebral artery (V¯ P ); transcranial Doppler ultrasound) and cardiovascular (blood pressure, heart rate) responses to hypoxia and hypercapnia', 'cerebral blood flow responses', 'V¯ P  and blood pressure responses to hypoxia and hypercapnic', 'cerebrovascular and cardiovascular response']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}]",10.0,0.0240306,Sleep accompanied by IH had no impact on the V¯ P  and blood pressure responses to hypoxia and hypercapnic at any timepoint (p > 0.103 for all responses).,"[{'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Beaudin', 'Affiliation': 'University of Calgary, Cumming School of Medicine, Department of Physiology and Pharmacology, 3330 Hospital Drive N.W., Calgary, Alberta T2N 4N1, Canada; Hotchkiss Brain Institute, University of Calgary, Cumming School of Medicine, 3330 Hospital Drive N.W., Calgary, Alberta T2N 4N1, Canada.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hanly', 'Affiliation': 'Hotchkiss Brain Institute, University of Calgary, Cumming School of Medicine, 3330 Hospital Drive N.W., Calgary, Alberta T2N 4N1, Canada; University of Calgary, Cumming School of Medicine, Department of Medicine, 3330 Hospital Drive N.W., Calgary, Alberta T2N 4N1, Canada; Sleep Centre, Foothills Medical Centre, 1403 29 St NW, Calgary, Alberta T2N 2T9, Canada.'}, {'ForeName': 'Jill K', 'Initials': 'JK', 'LastName': 'Raneri', 'Affiliation': 'Sleep Centre, Foothills Medical Centre, 1403 29 St NW, Calgary, Alberta T2N 2T9, Canada.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Younes', 'Affiliation': 'University of Manitoba, Department of Medicine, 1105-255 Wellington Crescent, Winnipeg, Manitoba R3M 3V4, Canada.'}, {'ForeName': 'Matiram', 'Initials': 'M', 'LastName': 'Pun', 'Affiliation': 'University of Calgary, Cumming School of Medicine, Department of Physiology and Pharmacology, 3330 Hospital Drive N.W., Calgary, Alberta T2N 4N1, Canada; Hotchkiss Brain Institute, University of Calgary, Cumming School of Medicine, 3330 Hospital Drive N.W., Calgary, Alberta T2N 4N1, Canada.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Anderson', 'Affiliation': 'University of Calgary, Cumming School of Medicine, Department of Cardiac Science, 3330 Hospital Drive N.W., Calgary, Alberta T2N 4N1, Canada; Libin Cardiovascular Institute of Alberta, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Poulin', 'Affiliation': 'University of Calgary, Cumming School of Medicine, Department of Physiology and Pharmacology, 3330 Hospital Drive N.W., Calgary, Alberta T2N 4N1, Canada; Hotchkiss Brain Institute, University of Calgary, Cumming School of Medicine, 3330 Hospital Drive N.W., Calgary, Alberta T2N 4N1, Canada; Libin Cardiovascular Institute of Alberta, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Faculty of Kinesiology, University of Calgary, Calgary, AB, Canada. Electronic address: poulin@ucalgary.ca.'}]",Experimental neurology,['10.1016/j.expneurol.2021.113897']
1963,34655570,Repeated exposure to epigallocatechin gallate solution or water alters bitterness intensity and salivary protein profile.,"Polyphenols, bitter and astringent compounds present in many healthy foods, induce varied sensory responses across individuals. These differences in liking and flavor intensity may be attributable, in part, to differences in saliva. In the current study, we tested the effect of repeated consumption of a bitter polyphenol (epigallocatechin gallate, EGCG) solution on perceived bitterness intensity and salivary protein composition. We hypothesized exposure to EGCG would cause an increase in concentrations of salivary proteins that inhibit bitterness of polyphenols. We also hypothesized that participants with higher habitual polyphenol, specifically the flavanols, intake would experience less bitterness from EGCG solutions than those with low habitual intake, and that the high flavanol consumers would be more resistant to salivary alterations. We also tested whether bovine milk casein, a food analog for salivary proteins that may suppress bitterness, would decrease bitterness intensity of the EGCG solution and mitigate effects of the intervention. Participants (N = 37) in our crossover intervention adhered to two-week periods of daily bitter (EGCG) or control (water) solution consumption. Bitterness intensity ratings and citric acid-stimulated saliva were collected at baseline and after each exposure period. Results indicate that bitterness intensity of the EGCG solution decreased after polyphenol (bitter EGCG) exposure compared to control (water) exposure. Casein addition also decreased bitterness intensity of the EGCG solution. While there was not a significant overall main effect of baseline flavanol intake on solution bitterness, there was an interaction between intervention week and baseline flavanol intake. Surprisingly, the higher flavanol intake group rated EGCG solutions as more bitter than the low and medium intake groups. Of proteins relevant to taste perception, several cystatins changed in saliva in response to the intervention. Interestingly, most of these protein alterations occurred more robustly after the control (water) exposure rather than the bitter (EGCG) exposure, suggesting that additional factors not quantified in this work may influence salivary proteins. Thus, we confirm in this study that exposure to bitterness suppresses ratings of bitterness over time, but more work needs to establish the causal factors of how diet influences salivary proteins.",2021,"Surprisingly, the higher flavanol intake group rated EGCG solutions as more bitter than the low and medium intake groups.",['participants with higher habitual polyphenol'],"['polyphenol (bitter EGCG', 'Casein', 'EGCG', 'bovine milk casein', 'daily bitter (EGCG) or control (water) solution consumption', 'bitter polyphenol (epigallocatechin gallate, EGCG) solution']","['Bitterness intensity ratings and citric acid-stimulated saliva', 'bitterness intensity', 'liking and flavor intensity']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C2720503', 'cui_str': 'casein allergenic extract'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}]",,0.0373979,"Surprisingly, the higher flavanol intake group rated EGCG solutions as more bitter than the low and medium intake groups.","[{'ForeName': 'Lissa A', 'Initials': 'LA', 'LastName': 'Davis', 'Affiliation': 'Department of Nutrition Science, Purdue University, Stone Hall, 700 W State St., West Lafayette, IN 47907, USA.'}, {'ForeName': 'Cordelia A', 'Initials': 'CA', 'LastName': 'Running', 'Affiliation': 'Department of Nutrition Science, Purdue University, Stone Hall, 700 W State St., West Lafayette, IN 47907, USA. Electronic address: crunning@purdue.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2021.113624']
1964,34655533,"Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial.","BACKGROUND


In the primary analysis of the phase 3 MAIA trial (median follow-up 28·0 months), a significant improvement in progression-free survival was observed with daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in transplantation-ineligible patients with newly diagnosed multiple myeloma. Here, we report the updated efficacy and safety results from a prespecified interim analysis for overall survival.
METHODS


MAIA is an ongoing, multicentre, randomised, open-label, phase 3 trial that enrolled patients at 176 hospitals in 14 countries across North America, Europe, the Middle East, and the Asia-Pacific region. Eligible patients were aged 18 years or older, had newly diagnosed multiple myeloma, had an Eastern Cooperative Oncology Group performance status score of 0-2, and were ineligible for high-dose chemotherapy with autologous stem-cell transplantation because of their age (≥65 years) or comorbidities. Patients were randomly assigned (1:1) using randomly permuted blocks (block size 4) by an interactive web response system to receive 28-day cycles of intravenous daratumumab (16 mg/kg, once per week during cycles 1-2, once every 2 weeks in cycles 3-6, and once every 4 weeks thereafter) plus oral lenalidomide (25 mg on days 1-21 of each cycle) and oral dexamethasone (40 mg on days 1, 8, 15, and 22 of each cycle; daratumumab group) or lenalidomide and dexamethasone alone (control group). Randomisation was stratified by International Staging System disease stage, geographical region, and age. Neither patients nor investigators were masked to treatment assignment. The primary endpoint was progression-free survival, which was centrally assessed, and a secondary endpoint was overall survival (both assessed in the intention-to-treat population). The safety population included patients who received at least one dose of the study treatment. The results presented here are from a prespecified interim analysis for overall survival, for which the prespecified stopping boundary was p=0·0414. This trial is registered with ClinicalTrials.gov, NCT02252172.
FINDINGS


Between March 18, 2015, and Jan 15, 2017, 952 patients were assessed for eligibility, of whom 737 patients were enrolled and randomly assigned to the daratumumab group (n=368) or the control group (n=369). At a median follow-up of 56·2 months (IQR 52·7-59·9), median progression-free survival was not reached (95% CI 54·8-not reached) in the daratumumab group versus 34·4 months (29·6-39·2) in the control group (hazard ratio [HR] 0·53 [95% CI 0·43-0·66]; p<0·0001). Median overall survival was not reached in either group (daratumumab group, 95% CI not reached-not reached; control group, 95% CI 55·7-not reached; HR 0·68 [95% CI 0·53-0·86]; p=0·0013). The most common (>15%) grade 3 or higher treatment-emergent adverse events were neutropenia (197 [54%] patients in the daratumumab group vs 135 [37%] patients in the control group), pneumonia (70 [19%] vs 39 [11%]), anaemia (61 [17%] vs 79 [22%]), and lymphopenia (60 [16%] vs 41 [11%]). Serious adverse events occurred in 281 (77%) patients in the daratumumab group and 257 (70%) patients in the control group. Treatment-related deaths occurred in 13 (4%) patients in the daratumumab group and ten (3%) patients in the control group.
INTERPRETATION


Daratumumab plus lenalidomide and dexamethasone increased overall survival and progression-free survival in patients ineligible for stem-cell transplantation with newly diagnosed multiple myeloma. There were no new safety concerns. Our results support the frontline use of daratumumab plus lenalidomide and dexamethasone for patients with multiple myeloma who are ineligible for transplantation.
FUNDING


Janssen Research & Development.",2021,"Median overall survival was not reached in either group (daratumumab group, 95% CI not reached-not reached; control group, 95% CI 55·7-not reached; HR 0·68","['0·53', 'patients with multiple myeloma who are ineligible for transplantation', 'enrolled patients at 176 hospitals in 14 countries across North America, Europe, the Middle East, and the Asia-Pacific region', 'transplantation-ineligible patients with newly diagnosed multiple myeloma', 'Between March 18, 2015, and Jan 15, 2017, 952 patients were assessed for eligibility, of whom 737 patients were enrolled and randomly assigned to the daratumumab group (n=368) or the control group (n=369', 'newly diagnosed multiple myeloma (MAIA', 'Eligible patients were aged 18 years or older, had newly diagnosed multiple myeloma, had an Eastern Cooperative Oncology Group performance status score of 0-2, and were ineligible for high-dose chemotherapy with autologous stem-cell transplantation because of their age (≥65 years) or comorbidities', 'patients who received at least one dose of the study treatment', 'patients ineligible for stem-cell transplantation with newly diagnosed multiple myeloma']","['Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone', 'randomly permuted blocks (block size 4) by an interactive web response system to receive 28-day cycles of intravenous daratumumab', 'dexamethasone', 'lenalidomide and dexamethasone alone (control group', 'lenalidomide and dexamethasone', 'oral lenalidomide', 'oral dexamethasone']","['neutropenia', 'median progression-free survival', 'progression-free survival', 'lymphopenia', 'Median overall survival', 'Serious adverse events', 'anaemia', 'overall survival', 'deaths', 'overall survival and progression-free survival', 'pneumonia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0026068', 'cui_str': 'Middle east country'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",952.0,0.632424,"Median overall survival was not reached in either group (daratumumab group, 95% CI not reached-not reached; control group, 95% CI 55·7-not reached; HR 0·68","[{'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'University of Lille, Centre Hospitalier Universitaire de Lille, Service des Maladies du Sang, Lille, France. Electronic address: thierry.facon@chru-lille.fr.'}, {'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Department of Hematology, Mayo Clinic Rochester, Rochester, MN, USA.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Plesner', 'Affiliation': 'Vejle Hospital and University of Southern Denmark, Vejle, Denmark.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Bahlis', 'Affiliation': 'Arnie Charbonneau Cancer Research Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Supratik', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'The Royal Wolverhampton NHS Trust and University of Wolverhampton, Wolverhampton, UK.'}, {'ForeName': 'Hareth', 'Initials': 'H', 'LastName': 'Nahi', 'Affiliation': 'Karolinska Institute, Department of Medicine, Division of Hematology, Karolinska University Hospital at Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Hulin', 'Affiliation': 'Department of Hematology, Hôpital Haut Lévêque, University Hospital, Pessac, France.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne, St Vincent's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Hospital Heidelberg, Internal Medicine V and National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Dwyer"", 'Affiliation': 'Department of Medicine/Haematology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Perrot', 'Affiliation': ""Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse - Oncopole, Université de Toulouse, Université Paul Sabatier, Service d'Hématologie, Toulouse, France.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Venner', 'Affiliation': 'Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Mace', 'Affiliation': 'Florida Cancer Specialists, St Petersburg, FL, USA.'}, {'ForeName': 'Noopur', 'Initials': 'N', 'LastName': 'Raje', 'Affiliation': 'Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Tiab', 'Affiliation': 'Centre Hospitalier Départemental Vendée, La Roche sur Yon, France.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Macro', 'Affiliation': 'Centre Hospitalier Universitaire de Caen, Caen, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Frenzel', 'Affiliation': 'Department of Clinical Haematology, Hopital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Hôpital la Milétrie, Poitiers, France.'}, {'ForeName': 'Tahamtan', 'Initials': 'T', 'LastName': 'Ahmadi', 'Affiliation': 'Genmab US, Plainsboro, NJ, USA.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Rian', 'Initials': 'R', 'LastName': 'Van Rampelbergh', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Clarissa M', 'Initials': 'CM', 'LastName': 'Uhlar', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Tromp', 'Affiliation': 'Janssen Research & Development, Leiden, Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Delioukina', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Janssen Research & Development, Leiden, Netherlands.'}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00466-6']
1965,34656029,Postoperative arginine-enriched immune modulating nutrition: Long-term survival results from a randomised clinical trial in patients with oesophagogastric and pancreaticobiliary cancer.,"BACKGROUND & AIMS


Immune modulating nutrition (IMN) has been shown to reduce postoperative infectious complications and length of stay in patients with gastrointestinal cancer. Two studies of IMN in patients undergoing surgery for head and neck cancer also suggested that this treatment might improve long-term survival and progression-free survival. In the present study, we analysed follow-up data from our previous randomised controlled trial of IMN, in patients undergoing surgery for oesophagogastric and pancreaticobiliary cancer, in order to evaluate the long-term impact on survival of postoperative IMN versus an isocaloric, isonitrogenous control feed.
METHODS


This study included patients undergoing surgery for cancers of the pancreas, oesophagus and stomach, who had been randomised in a double-blind manner to receive postoperative jejunostomy feeding with IMN (Stresson, Nutricia Ltd.) or an isonitrogenous, isocaloric feed (Nutrison High Protein, Nutricia) for 10-15 days. The primary outcome was long-term overall survival.
RESULTS


There was complete follow-up for all 108 patients, with 54 patients randomised to each group. There were no statistically significant differences between groups by demographics [(age, p = 0.63), sex (p = 0.49) or site of cancer (p = 0.25)]. 30-day mortality was 11.1% in both groups. Mortality in the intervention group was 13%, 31.5%, 70.4%, 85.2%, 88.9%, and 96.3% at 90 days, and 1, 5, 10, 15 and 20 years respectively. Corresponding mortality in the control group was 14.8%, 35.2%, 68.6%, 79.6%, 85.2% and 98.1% (p > 0.05 for all comparisons).
CONCLUSION


Early postoperative feeding with arginine-enriched IMN had no impact on long-term survival in patients undergoing surgery for oesophagogastric and pancreaticobiliary cancer.",2021,Early postoperative feeding with arginine-enriched IMN had no impact on long-term survival in patients undergoing surgery for oesophagogastric and pancreaticobiliary cancer.,"['patients undergoing surgery for oesophagogastric and pancreaticobiliary cancer', 'patients with oesophagogastric and pancreaticobiliary cancer', 'patients undergoing surgery for cancers of the pancreas, oesophagus and stomach, who had been randomised in a double-blind manner to receive', 'patients undergoing surgery for head and neck cancer', 'patients with gastrointestinal cancer']","['Postoperative arginine-enriched immune modulating nutrition', 'arginine-enriched IMN', 'IMN', 'postoperative jejunostomy feeding with IMN (Stresson, Nutricia Ltd.) or an isonitrogenous, isocaloric feed (Nutrison High Protein, Nutricia']","['30-day mortality', 'long-term overall survival', 'long-term survival and progression-free survival', 'long-term survival', 'Mortality', 'Corresponding mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0192715', 'cui_str': 'Jejunostomy feeding'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",108.0,0.470458,Early postoperative feeding with arginine-enriched IMN had no impact on long-term survival in patients undergoing surgery for oesophagogastric and pancreaticobiliary cancer.,"[{'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Adiamah', 'Affiliation': 'Nottingham Digestive Diseases Centre and National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Katie E', 'Initials': 'KE', 'LastName': 'Rollins', 'Affiliation': 'Nottingham Digestive Diseases Centre and National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Kapeleris', 'Affiliation': 'Nottingham Digestive Diseases Centre and National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Neil T', 'Initials': 'NT', 'LastName': 'Welch', 'Affiliation': 'Nottingham Digestive Diseases Centre and National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Syed Y', 'Initials': 'SY', 'LastName': 'Iftikhar', 'Affiliation': 'University Hospitals of Derby and Burton NHS Foundation Trust, Royal Derby Hospital, Uttoxeter Road, Derby, UK.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Allison', 'Affiliation': 'Nottingham Digestive Diseases Centre and National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Dileep N', 'Initials': 'DN', 'LastName': 'Lobo', 'Affiliation': ""Nottingham Digestive Diseases Centre and National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK; MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, UK. Electronic address: Dileep.Lobo@nottingham.ac.uk.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.09.040']
1966,34655816,Efficacy of cardiopulmonary resuscitation performance while wearing a powered air-purifying respirator.,"BACKGROUND


The use of personal protective equipment for respiratory infection control during cardiopulmonary resuscitation (CPR) is a physical burden to healthcare providers. The duration for which CPR quality according to recommended guidelines can be maintained under these circumstances is important. We investigated whether a 2-min shift was appropriate for chest compression and determined the duration for which chest compression was maintained in accordance with the recommended guidelines while wearing personal protective equipment.
METHODS


This prospective crossover simulation study was performed at a single center from September 2020 to October 2020. Five indicators of CPR quality were measured during the first and second sessions of the study period. All participants wore a Level D powered air-purifying respirator (PAPR), and the experiment was conducted using a Resusci Anne manikin, which can measure the quality of chest compressions. Each participant conducted two sessions. In Session 1, the sequence of 2 min of chest compressions, followed by a 2-min rest, was repeated twice; in Session 2, the sequence of 1-min chest compressions followed by a 1-min rest was repeated four times.
RESULTS


All 34 participants completed the study. The sufficiently deep compression rate was 65.9 ± 31.1% in the 1-min shift group and 61.5 ± 30.5% in the 2-min shift group. The mean compression depth was 52.8 ± 4.3 mm in the 1-min shift group and 51.0 ± 6.1 mm in the 2-min shift group. These two parameters were significantly different between the two groups. There was no significant difference in the other values related to CPR quality.
CONCLUSIONS


Our findings indicated that 1 min of chest compressions with a 1-min rest maintained a better quality of CPR while wearing a PAPR.",2021,The use of personal protective equipment for respiratory infection control during cardiopulmonary resuscitation (CPR) is a physical burden to healthcare providers.,"['All 34 participants completed the study', 'single center from September 2020 to October 2020']","['personal protective equipment', 'Level D powered air-purifying respirator (PAPR', 'cardiopulmonary resuscitation (CPR', 'cardiopulmonary resuscitation performance']","['CPR quality', 'mean compression depth', 'deep compression rate']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",,0.0153096,The use of personal protective equipment for respiratory infection control during cardiopulmonary resuscitation (CPR) is a physical burden to healthcare providers.,"[{'ForeName': 'Jun Young', 'Initials': 'JY', 'LastName': 'Chong', 'Affiliation': 'Department of Emergency Medicine, Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'ChangShin', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Emergency Medicine, Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Wonjoon', 'Initials': 'W', 'LastName': 'Jeong', 'Affiliation': 'Department of Emergency Medicine, Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Jung Soo', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Chungnam National University Hospital, Daejeon, South Korea; Department of Emergency Medicine, College of medicine, Chungnam National University, Daejeon, South Korea.'}, {'ForeName': 'Yeonho', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Department of Emergency Medicine, Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Hong Joon', 'Initials': 'HJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Emergency Medicine, Chungnam National University Hospital, Daejeon, South Korea; Department of Emergency Medicine, College of medicine, Chungnam National University, Daejeon, South Korea.'}, {'ForeName': 'Jin Hong', 'Initials': 'JH', 'LastName': 'Min', 'Affiliation': 'Department of Emergency Medicine, Chungnam National University Hospital, Daejeon, South Korea; Department of Emergency Medicine, College of medicine, Chungnam National University, Daejeon, South Korea.'}, {'ForeName': 'TaeSik', 'Initials': 'T', 'LastName': 'Hwang', 'Affiliation': 'Department of Emergency Medicine, Haeundae Paik Hospital, Inje University, Pusan, Republic of Korea.'}, {'ForeName': 'OYu', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Anatomy, Medical College of Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Seung Whan', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Chungnam National University Hospital, Daejeon, South Korea; Department of Emergency Medicine, College of medicine, Chungnam National University, Daejeon, South Korea. Electronic address: emfire@cnuh.co.kr.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.09.060']
1967,34655765,"Automated Text-Messaging After Hip Arthroscopy: A Randomized-Controlled Trial of ""Post-Op Buddy"".","PURPOSE


To assess an automated text-messaging system for patients after hip arthroscopy and its impact at 90 days on the Hip Disability Osteoarthritis Outcome Score Physical Function Short form (HOOS-PS, HOOS-Pain), compliance with rehabilitation guidelines, and patient satisfaction.
METHODS


One hundred twenty-one participants (average age 29 ± 8.7 years, 52% female) undergoing hip arthroscopy at 2 academic institutions were prospectively enrolled and randomized to receive (1) standard perioperative communication or (2) additional automated mobile phone text messages. Inclusion criteria included ability to communicate in written English and access to a mobile phone with text-messaging capability. Patients undergoing revision surgery or simultaneous femoral or acetabular osteotomy were excluded. HOOS-PS and HOOS-Pain were collected preoperatively, and after surgery an automated mobile phone robot sent participants in the therapeutic arm intermittent text messages for 90 days. At 90 days all participants again completed HOOS-PS, HOOS-Pain, and additional survey questions on satisfaction with their experience (10-point scale), communication from the surgical team (10-point scale) and adherence to physical therapy exercises, weight-bearing guidelines, and brace use, The primary outcome assessed was a statistically significant change in HOOS-PS and HOOS-Pain; secondary outcomes included change in satisfaction, communication, and adherence to physical therapy exercises, weightbearing guidelines, or brace use. Wilcoxon rank sum was used to compare HOOS-PS and HOOS-Pain scores at 0 and 90 days. Demographic characteristics and survey variables were compared using Students t test for continuous variables and χ 2  or Fisher exact test for categorical variables as appropriate.
RESULTS


There were statistically significant and clinically relevant improvements in HOOS-PS and HOOS-Pain in both groups (P < .05). Subjective feedback was strongly positive, with 96% of text message participants reporting they would choose automated messages if it was offered to them again in the future.
CONCLUSIONS


Ninety days of automated text messaging after hip arthroscopy failed to show a significant difference in HOOS-PS (P = .09), HOOS-Pain (P = .13), patient-reported compliance with postoperative guidelines, or satisfaction with support and communication from the surgical team.
LEVEL OF EVIDENCE


I, randomized control trial (RCT).",2021,There were statistically significant and clinically relevant improvements in HOOS-PS and HOOS-PAIN in both groups (p<0.05).,"['One hundred twenty-one participants (average age 29±8.7 years, 52% female) undergoing hip arthroscopy at two academic institutions', 'Patients undergoing revision surgery or simultaneous femoral or acetabular osteotomy were excluded', 'After Hip Arthroscopy']","['standard perioperative communication or (2) additional automated mobile phone text messages', 'Post-Op Buddy', 'Automated Text Messaging']","['HOOS-PAIN', 'HOOS-PS', 'Hip Disability Osteoarthritis Outcome Score (HOOS-PS, HOOS-PAIN), compliance with rehabilitation guidelines and patient satisfaction', 'Subjective feedback', 'HOOS-PS and HOOS-PAIN; secondary outcomes included change in satisfaction, communication, and adherence to physical therapy exercises, weightbearing guidelines, or brace use', 'HOOS-PS and HOOS-PAIN', 'HOOS-PS, HOOS-PAIN, and additional survey questions on satisfaction with their experience (10-point scale), communication from the surgical team (10-point scale) and adherence to physical therapy exercises, weightbearing guidelines, and brace use', 'HOOS-PS and HOOS-PAIN scores']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0186116', 'cui_str': 'Osteotomy of acetabular bone'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",121.0,0.108636,There were statistically significant and clinically relevant improvements in HOOS-PS and HOOS-PAIN in both groups (p<0.05).,"[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Scott', 'Affiliation': 'Department of Orthopedics and Rehabilitation, University of Iowa, Iowa City, Iowa, U.S.A.. Electronic address: lizscottmd@gmail.com.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Anthony', 'Affiliation': 'Department of Orthopaedics, University of Pennsylvania, Philadelphia, Pennsylvania, U.S.A.'}, {'ForeName': 'Michaela J', 'Initials': 'MJ', 'LastName': ""O'Connor"", 'Affiliation': 'Columbia University Medical Center, New York, New York, U.S.A.'}, {'ForeName': 'T Sean', 'Initials': 'TS', 'LastName': 'Lynch', 'Affiliation': 'Columbia University Medical Center, New York, New York, U.S.A.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Westermann', 'Affiliation': 'Department of Orthopedics and Rehabilitation, University of Iowa, Iowa City, Iowa, U.S.A.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2021.09.030']
1968,34649130,"Temporal Relationships Between Pain During Intercourse (PDI), Loneliness, and Depressive Symptoms Among Women.","BACKGROUND


Painful sex can lead to increased psychological distress, including major depressive disorder, and the experience of loneliness may explain this association.
AIMS


We aimed to investigate loneliness as a mediator between painful sex and depressive symptoms and hypothesized that women who experienced greater pain during intercourse (ie, more severe and more frequent pain) would endorse higher rates of loneliness and, in turn, higher rates of depressive symptoms at a 6-month follow-up.
METHODS


Participants were 148 adults who were assigned female at birth (78.4% white, 77% partnered, 31.14 ± 10.9 years old) and completed an online, anonymous survey including the Female Sexual Function Index (FSFI), UCLA Loneliness Scale-3 (ULS), and demographic information.
MAIN OUTCOME MEASURE


Depressive symptoms, measured via the Patient Health Questionnaire-8 (PHQ8) at baseline (T1) and 6-month follow-up (T2) were used as the outcomes of the present study.
RESULTS


Painful sex and ULS at T1 were significantly correlated with each other and with PHQ8 at T1 (r = 0.590). However, change in PHQ8 from T1 to T2 was not significantly correlated with ULS (r = 0.024) or any other key study variables, indicating that that ULS was not a significant mediator of the relationship between painful sex at T1 and change in PHQ8 (standardized indirect effect = 0.011; 99% CI = -0.114 to 0.188).
CONCLUSION


These findings are consistent with previous studies highlighting that painful sex is related to depressive symptoms through loneliness cross-sectionally, suggesting that future treatments for depressive symptoms among women who experience painful sex might target loneliness. Stout ME, Hawkins MAW. Temporal Relationships Between Pain During Intercourse (PDI), Loneliness, and Depressive Symptoms Among Women. Sex Med 2021;9:100444.",2021,"RESULTS


Painful sex and ULS at T1 were significantly correlated with each other and with PHQ8 at T1 (r = 0.590).","['Participants were 148 adults who were assigned female at birth (78.4% white, 77% partnered, 31.14 ± 10.9 years old) and completed an online, anonymous survey including the']",[],"['During Intercourse (PDI), Loneliness, and Depressive Symptoms', 'Depressive symptoms, measured via the Patient Health Questionnaire-8 (PHQ8', 'Female Sexual Function Index (FSFI), UCLA Loneliness Scale-3 (ULS), and demographic information', 'Pain', 'painful sex at T1 and change in PHQ8']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",148.0,0.062962,"RESULTS


Painful sex and ULS at T1 were significantly correlated with each other and with PHQ8 at T1 (r = 0.590).","[{'ForeName': 'Madison E', 'Initials': 'ME', 'LastName': 'Stout', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK, USA.'}, {'ForeName': 'Misty A W', 'Initials': 'MAW', 'LastName': 'Hawkins', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK, USA. Electronic address: misty.hawkins@okstate.edu.'}]",Sexual medicine,['10.1016/j.esxm.2021.100444']
1969,34649098,Long-term add-on Yoga therapy offers clinical benefits in major depressive disorder by modulating the complement pathway: A randomized controlled trial.,,2021,,[],['Yoga therapy'],[],[],"[{'cui': 'C1883583', 'cui_str': 'Yoga'}]",[],,0.209544,,"[{'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Subbanna', 'Affiliation': 'Department of Human Genetics, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Pinku Mani', 'Initials': 'PM', 'LastName': 'Talukdar', 'Affiliation': 'Department of Human Genetics, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Fazal', 'Initials': 'F', 'LastName': 'Abdul', 'Affiliation': 'Department of Human Genetics, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Monojit', 'Initials': 'M', 'LastName': 'Debnath', 'Affiliation': 'Department of Human Genetics, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India. Electronic address: monozeet@gmail.com.'}, {'ForeName': 'Preethi V', 'Initials': 'PV', 'LastName': 'Reddy', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Arasappa', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Kesavan', 'Initials': 'K', 'LastName': 'Muralidharan', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Bangalore N', 'Initials': 'BN', 'LastName': 'Gangadhar', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Praerna H', 'Initials': 'PH', 'LastName': 'Bhargav', 'Affiliation': 'Department of Integrative Medicine, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Karmani', 'Affiliation': 'Department of Integrative Medicine, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2021.102876']
1970,34649083,A new electronically based clinical pathway for schizophrenia inpatients: A longitudinal pilot study.,"Patients with schizophrenia, a severe chronic disorder, are characterized by resistance to therapy, lack of disease understanding, non-compliance and non-adherence, partly caused and maintained by an often poorly structured treatment strategy and polypharmacy. Treatment pathways in the sense of decision aids for professionals bring recommendations from guidelines into a clear and practice-oriented algorithm that can be a helpful tool for treatment. The aim of the present study was to assess the impact of a newly developed electronic clinical pathway (CPW) that integrates the standard computerized medical report system on symptomatic outcomes and process parameters in a population of inpatients with schizophrenia. In this randomized single-center study, 156 patients with schizophrenic disorder were treated in two groups: an experimental CPW group and a control ""treatment as usual"" (TAU) group. The treatment improvement was analyzed using various process parameters: the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression scale (CGI), the Personal and Social Performance scale (PSP) and the Nurses' Observation Scale for Inpatient Evaluation (NOSIE). The CPW patients differentially showed greater improvement in psychopathology (PANSS) compared to TAU patients (t(154) = 2.030, p = 0.044). There also seems to be advantage for CPW concerning improvement in NOSIE. These results indicate a positive influence of CPW on the quality of treatment and support its implementation in daily clinical practice.",2021,The CPW patients differentially showed greater improvement in psychopathology (PANSS) compared to TAU patients (t(154) = ,"['schizophrenia inpatients', 'inpatients with schizophrenia', 'Patients with schizophrenia, a severe chronic disorder', '156 patients with schizophrenic disorder']","['experimental CPW group and a control ""treatment as usual"" (TAU']","['psychopathology (PANSS', ""Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression scale (CGI), the Personal and Social Performance scale (PSP) and the Nurses' Observation Scale for Inpatient Evaluation (NOSIE""]","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0282654', 'cui_str': 'Clinical Pathways'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",156.0,0.0143261,The CPW patients differentially showed greater improvement in psychopathology (PANSS) compared to TAU patients (t(154) = ,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Norra', 'Affiliation': 'Department of Preventive Medicine, LWL University Hospital, Ruhr University Bochum, Bochum, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, LWL Hospital Paderborn, Germany.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Ueberberg', 'Affiliation': 'Department of Preventive Medicine, LWL University Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Juckel', 'Affiliation': 'Department of Preventive Medicine, LWL University Hospital, Ruhr University Bochum, Bochum, Germany. Electronic address: georg.juckel@lwl.org.'}]",Schizophrenia research,['10.1016/j.schres.2021.10.001']
1971,34648961,Modulating medial prefrontal cortex activity using real-time fMRI neurofeedback: Effects on reality monitoring performance and associated functional connectivity.,"Neuroimaging studies have found 'reality monitoring', our ability to distinguish internally generated experiences from those derived from the external world, to be associated with activity in the medial prefrontal cortex (mPFC) of the brain. Here we probe the functional underpinning of this ability using real-time fMRI neurofeedback to investigate the involvement of mPFC in recollection of the source of self-generated information. Thirty-nine healthy individuals underwent neurofeedback training in a between groups study receiving either Active feedback derived from the paracingulate region of the mPFC (21 subjects) or Sham feedback based on a similar level of randomised signal (18 subjects). Compared to those in the Sham group, participants receiving Active signal showed increased mPFC activity over the course of three real-time neurofeedback training runs undertaken in a single scanning session. Analysis of resting state functional connectivity associated with changes in reality monitoring accuracy following Active neurofeedback revealed increased connectivity between dorsolateral frontal regions of the fronto-parietal network (FPN) and the mPFC region of the default mode network (DMN), together with reduced connectivity within ventral regions of the FPN itself. However, only a trend effect was observed in the interaction of the recollection of the source of Imagined information compared with recognition memory between participants receiving Active and Sham neurofeedback, pre- and post- scanning. As such, these findings demonstrate that neurofeedback can be used to modulate mPFC activity and increase cooperation between the FPN and DMN, but the effects on reality monitoring performance are less clear.",2021,"Compared to those in the Sham group, participants receiving Active signal showed increased mPFC activity over the course of three real-time neurofeedback training runs undertaken in a single scanning session.",['Thirty-nine healthy individuals underwent'],"['Active feedback derived from the paracingulate region of the mPFC (21 subjects) or Sham feedback', 'neurofeedback training']",['mPFC activity'],"[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",39.0,0.033477,"Compared to those in the Sham group, participants receiving Active signal showed increased mPFC activity over the course of three real-time neurofeedback training runs undertaken in a single scanning session.","[{'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Garrison', 'Affiliation': 'Department of Psychology, University of Cambridge, Downing St, Cambridge CB2 3EB, United Kingdom; Behavioral and Clinical Neuroscience Institute, University of Cambridge, Downing St, Cambridge CB2 3EB, United Kingdom. Electronic address: jrg60@cam.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Saviola', 'Affiliation': 'School of Psychology, University of Roehampton, Whitelands College, Holybourne Avenue, London SW15 4JD, United Kingdom; CIMeC, Center for Mind/Brain Sciences, University of Trento, Rovereto, Trento 38068, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Morgenroth', 'Affiliation': 'School of Psychology, University of Roehampton, Whitelands College, Holybourne Avenue, London SW15 4JD, United Kingdom; Institute of Bioengineering, École Polytechnique Fédérale de Lausanne (EPFL), Route Cantonale, Lausanne 1015, Switzerland; Department of Radiology and Medical Informatics, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Barker', 'Affiliation': 'School of Psychology, University of Roehampton, Whitelands College, Holybourne Avenue, London SW15 4JD, United Kingdom.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lührs', 'Affiliation': 'Department of Cognitive Neuroscience, Maastricht University, Maastricht 6200 MD, The Netherlands; Research Department, Brain Innovation B.V., Oxfordlaan 55, Maastricht 6229 EV, The Netherlands.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Simons', 'Affiliation': 'Department of Psychology, University of Cambridge, Downing St, Cambridge CB2 3EB, United Kingdom; Behavioral and Clinical Neuroscience Institute, University of Cambridge, Downing St, Cambridge CB2 3EB, United Kingdom.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fernyhough', 'Affiliation': 'Department of Psychology, Durham University, Upper Mountjoy, South Rd, Durham DH1 3LE, United Kingdom.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Allen', 'Affiliation': 'School of Psychology, University of Roehampton, Whitelands College, Holybourne Avenue, London SW15 4JD, United Kingdom; Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, De Crespigny Park, London SE5 8AF, United Kingdom; Department of Psychiatry, Icahn Medical Institute, Mount Sinai Hospital, 1 Gustave L. Levy Place, Box 1230, New York, NY 10029, USA.'}]",NeuroImage,['10.1016/j.neuroimage.2021.118640']
1972,34673259,Increased migraine-free intervals with multifocal repetitive transcranial magnetic stimulation.,"INTRODUCTION


Episodic migraine is a debilitating condition associated with vast impairments of health, daily living, and life quality. Several prophylactic treatments exist, having a moderate ratio of action related to side effects and therapy costs. Repetitive transcranial magnetic stimulation (rTMS) is an evidence based therapy in several neuropsychiatric conditions, showing robust efficacy in alleviating specific symptoms. However, its efficacy in migraine disorders is unequivocal and might be tightly linked to the applied rTMS protocol. We hypothesized that multifocal rTMS paradigm could improve clinical outcomes in patients with episodic migraine by reducing the number of migraine days, frequency and intensity of migraine attacks, and improve the quality of life.
METHODS


We conducted an experimental, double-blind, randomized controlled study by applying a multifocal rTMS paradigm. Patients with episodic migraine with or without aura were enrolled in two centers from August 2018, to December 2019, and randomized to receive either real (n = 37) or sham (sham coil stimulation, n = 28) multifocal rTMS for six sessions over two weeks. Patients, physicians, and raters were blinded to the applied protocol. The experimental multifocal rTMS protocol included two components; first, swipe stimulation of 13 trains of 140 pulses/train, 67 Hz, 60% of RMT, and 2s intertrain interval and second, spot burst stimulation of 33 trains of 15 pulses/train, 67 Hz, 85% of RMT, and 8s intertrain interval. Reduction >50% from the baseline in migraine days (as primary outcome) and frequency and intensity of migraine attacks (as key secondary outcomes) over a 12-week period were assessed. To balance the baseline variables between the treatment arms, we applied the propensity score matching through the logistic regression.
RESULTS


Among 65 randomized patients, sixty (age 39.7 ± 11.6; 52 females; real rTMS n = 33 and sham rTMS n = 27) completed the trial and five patients dropped out. Over 12 weeks, the responder's rate in the number of migraine days was significantly higher in the real rTMS compared to the sham group (42% vs. 26%, p < 0.05). The mean migraine days per month decreased from 7.6 to 4.3 days in the real rTMS group and from 6.2 to 4.3 days in the sham rTMS group, resulting in a difference with real vs. sham rTMS of -3.2 days (p < 0.05). Similarly, over the 12-week period, the responder's rate in the reduction of migraine attacks frequency was higher in the real rTMS compared to the sham group (42% vs 33%, p < 0.05). No serious adverse events were observed.
CONCLUSION


Our pilot study shows compelling evidence in a double placebo-controlled trial that multifocal rTMS is an effective and well-tolerated preventive treatment in patients with episodic migraine.",2021,"Over 12 weeks, the responder's rate in the number of migraine days was significantly higher in the real rTMS compared to the sham group (42% vs. 26%, p < 0.05).","['65 randomized patients, sixty (age 39.7\xa0±\xa011.6; 52 females; real rTMS n\xa0=\xa033 and sham', 'patients with episodic migraine', 'Patients with episodic migraine with or without aura were enrolled in two centers from August 2018, to December 2019']","['placebo', 'Repetitive transcranial magnetic stimulation (rTMS', 'real (n\xa0=\xa037) or sham (sham coil stimulation, n\xa0=\xa028) multifocal rTMS']","['quality of life', 'frequency and intensity of migraine attacks', 'migraine attacks frequency', 'mean migraine days per month', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",65.0,0.155052,"Over 12 weeks, the responder's rate in the number of migraine days was significantly higher in the real rTMS compared to the sham group (42% vs. 26%, p < 0.05).","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Leahu', 'Affiliation': 'Department of Neurology, Focus Program Translational Neuroscience (FTN), Rhine-Main Neuroscience Network (rmn(2)), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany; Department of Neurology, Institute of Emergency Medicine, Chisinau, Republic of Moldova; Laboratory of Neurobiology and Medical Genetics, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Republic of Moldova.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Bange', 'Affiliation': 'Department of Neurology, Focus Program Translational Neuroscience (FTN), Rhine-Main Neuroscience Network (rmn(2)), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Dumitru', 'Initials': 'D', 'LastName': 'Ciolac', 'Affiliation': 'Department of Neurology, Focus Program Translational Neuroscience (FTN), Rhine-Main Neuroscience Network (rmn(2)), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany; Department of Neurology, Institute of Emergency Medicine, Chisinau, Republic of Moldova; Laboratory of Neurobiology and Medical Genetics, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Republic of Moldova.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Scheiter', 'Affiliation': 'Department of Neurology, Focus Program Translational Neuroscience (FTN), Rhine-Main Neuroscience Network (rmn(2)), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Matei', 'Affiliation': 'Department of Neurology, Institute of Emergency Medicine, Chisinau, Republic of Moldova.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gonzalez-Escamilla', 'Affiliation': 'Department of Neurology, Focus Program Translational Neuroscience (FTN), Rhine-Main Neuroscience Network (rmn(2)), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Venkata C', 'Initials': 'VC', 'LastName': 'Chirumamilla', 'Affiliation': 'Department of Neurology, Focus Program Translational Neuroscience (FTN), Rhine-Main Neuroscience Network (rmn(2)), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Stanislav A', 'Initials': 'SA', 'LastName': 'Groppa', 'Affiliation': 'Department of Neurology, Institute of Emergency Medicine, Chisinau, Republic of Moldova; Laboratory of Neurobiology and Medical Genetics, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Republic of Moldova.'}, {'ForeName': 'Muthuraman', 'Initials': 'M', 'LastName': 'Muthuraman', 'Affiliation': 'Department of Neurology, Focus Program Translational Neuroscience (FTN), Rhine-Main Neuroscience Network (rmn(2)), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Sergiu', 'Initials': 'S', 'LastName': 'Groppa', 'Affiliation': 'Department of Neurology, Focus Program Translational Neuroscience (FTN), Rhine-Main Neuroscience Network (rmn(2)), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany. Electronic address: segroppa@uni-mainz.de.'}]",Brain stimulation,['10.1016/j.brs.2021.10.383']
1973,34672961,"Enasidenib plus azacitidine versus azacitidine alone in patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia (AG221-AML-005): a single-arm, phase 1b and randomised, phase 2 trial.","BACKGROUND


Enasidenib is an oral inhibitor of mutant isocitrate dehydrogenase-2 (IDH2) proteins. We evaluated the safety and activity of enasidenib plus azacitidine versus azacitidine alone in patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia ineligible for intensive chemotherapy.
METHODS


This open-label, phase 1b/2 trial was done at 43 clinical sites in 12 countries (the USA, Germany, Canada, the UK, France, Spain, Australia, Italy, the Netherlands, Portugal, Switzerland, and South Korea). Eligible patients were aged 18 years or older and had newly diagnosed, mutant-IDH2 acute myeloid leukaemia, and an Eastern Cooperative Oncology Group performance status of 0-2. In the phase 1b dose-finding portion, patients received oral enasidenib 100 mg/day or 200 mg/day in continuous 28-day cycles, plus subcutaneous azacitidine 75 mg/m 2  per day for 7 days of each cycle. In phase 2, patients were randomly assigned (2:1) via an interactive web response system to enasidenib plus azacitidine or azacitidine-only, stratified by acute myeloid leukaemia subtype (de novo or secondary). The primary endpoint in the phase 2 portion was the overall response rate in the intention-to-treat population at a prespecified interim analysis (Aug 20, 2019) when all patients had at least 1 year of follow-up. Safety was assessed in all patients who received at least one dose of study drug. The trial is registered with ClinicalTrials.gov, NCT02677922, and is ongoing.
FINDINGS


Between June 3, 2016, and Aug 2, 2018, 322 patients were screened and 107 patients with mutant-IDH2 acute myeloid leukaemia were enrolled. At data cutoff for the interim analysis, 24 patients (including two from the phase 1 portion) were still receiving their assigned treatment. Six patients were enrolled in the phase 1b dose-finding portion of the trial and received enasidenib 100 mg (n=3) or 200 mg (n=3) in combination with azacitidine. No dose-limiting toxicities occurred and the enasidenib 100 mg dose was selected for phase 2. In phase 2, 101 patients were randomly assigned to enasidenib plus azacitidine (n=68) or azacitidine only (n=33). Median age was 75 years (IQR 71-78). 50 (74%; 95% CI 61-84) patients in the enasidenib plus azacitidine combination group and 12 (36%; 20-55) patients in the azacitidine monotherapy group achieved an overall response (odds ratio 4·9 [95% CI 2·0-11·9]; p=0·0003). Common treatment-related grade 3 or 4 adverse events with enasidenib plus azacitidine were thrombocytopenia (25 [37%] of 68 vs six [19%] of 32 in the azacitidine-only group), neutropenia (25 [37%] vs eight [25%]), anaemia (13 [19%] vs seven [22%]), and febrile neutropenia (11 [16%] vs five [16%]). Serious treatment-related adverse events were reported in 29 (43%) patients in the combination group and 14 (44%) patients in the azacitidine-only group; serious treatment-related adverse events occurring in more than 5% of patients in either group were febrile neutropenia (nine [13%] in the combination group vs five [16%] in the azacitidine-only group), differentiation syndrome (seven [10%] vs none), and pneumonia (three [4%] vs two [6%]). No treatment-related deaths were reported.
INTERPRETATION


Combination enasidenib plus azacitidine was well tolerated and significantly improved overall response rates compared with azacitidine monotherapy, suggesting that this regimen can improve outcomes for patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia.
FUNDING


Bristol Myers Squibb.",2021,"No treatment-related deaths were reported.
","['101 patients', 'patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia (AG221-AML-005', 'patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia', '24 patients (including two from the phase 1 portion) were still receiving their assigned treatment', 'Between June 3, 2016, and Aug 2, 2018, 322 patients were screened and 107 patients with mutant-IDH2 acute myeloid leukaemia were enrolled', 'Median age was 75 years (IQR 71-78', '43 clinical sites in 12 countries (the USA, Germany, Canada, the UK, France, Spain, Australia, Italy, the Netherlands, Portugal, Switzerland, and South Korea', 'Six patients were enrolled in the phase 1b dose-finding portion of the trial and received', 'Eligible patients were aged 18 years or older and had newly diagnosed, mutant-IDH2 acute myeloid leukaemia, and an Eastern Cooperative Oncology Group performance status of 0-2', 'patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia ineligible for intensive chemotherapy']","['subcutaneous azacitidine', 'oral enasidenib', 'enasidenib plus azacitidine versus azacitidine alone', 'azacitidine', 'Enasidenib plus azacitidine versus azacitidine alone', 'enasidenib 100 mg (n=3) or 200 mg (n=3) in combination with azacitidine', 'interactive web response system to enasidenib plus azacitidine or azacitidine', 'enasidenib plus azacitidine', 'azacitidine monotherapy']","['thrombocytopenia', 'overall response', 'adverse events', 'neutropenia', 'overall response rates', 'differentiation syndrome', 'pneumonia', 'anaemia', 'febrile neutropenia', 'Safety', 'No dose-limiting toxicities', 'overall response rate', 'serious treatment-related adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4519428', 'cui_str': 'enasidenib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4519447', 'cui_str': 'enasidenib 100 MG'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0860564', 'cui_str': 'Differentiation syndrome'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",6.0,0.158394,"No treatment-related deaths were reported.
","[{'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'Department of Leukemia, MD Anderson Cancer Center, University of Texas, Houston, TX, USA. Electronic address: cdinardo@mdanderson.org.'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Schuh', 'Affiliation': 'Cancer Clinical Research Unit, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Eytan M', 'Initials': 'EM', 'LastName': 'Stein', 'Affiliation': 'Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Department of Haematology, Hospital Universitari i Politecnic La Fe, Valencia, Spain.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'The Alfred Hospital and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'de Botton', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Amer M', 'Initials': 'AM', 'LastName': 'Zeidan', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Amir T', 'Initials': 'AT', 'LastName': 'Fathi', 'Affiliation': 'Hematology and Oncology, Harvard Medical School and Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Bennett', 'Affiliation': 'Department of Pathology, Hematopathology Division, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Frattini', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martin-Regueira', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Lersch', 'Affiliation': 'Celgene, a Bristol Myers Squibb Company, Boudry, Switzerland.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Maroof', 'Initials': 'M', 'LastName': 'Hasan', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Vyas', 'Affiliation': 'MRC Molecular Haematology Unit and Oxford Biomedical Research Centre, University of Oxford and Oxford University Hospitals, Oxford, UK.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, Universitätsklinikum Ulm, Ulm, Germany.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00494-0']
1974,34677151,"Effects of Iranian Polyherbal Syrup (Zufa syrup) on oxygen saturation and clinical symptoms in suspected patients with COVID-19: a triple-blinded, randomized, placebo-controlled trial.","Coronavirus disease 2019 (COVID-19) pandemic has caused an urgent need for investigating potential treatments. Traditional medicine offers many potential remedies that have been historically used and have the advantage of bypassing the cultural obstacles in the practice of medicine. We aimed to investigate the efficacy of Zufa syrup in the treatment of suspected patients with mild to moderate symptoms of COVID-19. This triple-blind randomized controlled trial recruited patients with evidence of COVID-19 on chest computed tomography without an indication of hospital admission from March 2020 until April 2020. Participants were assessed by a physician and completed a pre-specified form to assess the duration and severity of symptoms. Patients were randomized to receive Zufa syrup (a combination of herbal medicines: Nepetabracteata, Ziziphus jujube, Glycyrrhizaglabra, Ficuscarica, Cordia myxa, Papaver somniferum, Fennel, Adiantumcapillus-veneris, Viola, Viper's-buglosses, Lavender, Iris, and sugar) or identical-looking placebo syrup at a dose of 7.5 mL (one tablespoon) every 4 hours for 10 days. After applying the eligibility criteria, 116 patients (49.1% male) were randomized to trial arms with a mean age of 44.3. During the follow-up, Cough, dyspnea, headache, myalgia, anorexia, anxiety, and insomnia improved gradually in both groups, and showed no difference between Zufa syrup and placebo. Oxygen saturation and pulse rate had stable trends throughout the follow-up and were similar between study arms. No patient required hospital admission or supplemental oxygen therapy during the study period. To conclude, in patients with mild to moderate symptoms of COVID-19, Zufa syrup did not show any difference in symptomatology over a 10 days' period when compared with placebo. Due to potential effects of medicinal plants in the treatment of respiratory infections, further studies are warranted to clarify their role in COVID-19. The study was approved by the Ethics Committee of the Qom University of Medical Science (Ethics committee reference number IR.MUQ.REC.1398.165) on March 10, 2020 and was registered in Iranian Clinical Trial Center (approval ID: IRCT20200404046934N1) on April 13, 2020.",2022,"During the follow-up, Cough, dyspnea, headache, myalgia, anorexia, anxiety, and insomnia improved gradually in both groups, and showed no difference between Zufa syrup and placebo.","['suspected patients with COVID-19', 'suspected patients with mild to moderate symptoms of COVID-19', 'patients with evidence of COVID-19 on chest computed tomography without an indication of hospital admission from March 2020 until April 2020', '116 patients (49.1% male']","['medicinal plants', 'Iranian Polyherbal Syrup (Zufa syrup', 'Zufa syrup (a combination of herbal medicines', 'Zufa syrup', 'placebo']","['symptomatology', 'hospital admission or supplemental oxygen therapy', 'Oxygen saturation and pulse rate', 'duration and severity of symptoms', 'oxygen saturation and clinical symptoms', ""Nepetabracteata, Ziziphus jujube, Glycyrrhizaglabra, Ficuscarica, Cordia myxa, Papaver somniferum, Fennel, Adiantumcapillus-veneris, Viola, Viper's-buglosses, Lavender, Iris, and sugar"", 'Cough, dyspnea, headache, myalgia, anorexia, anxiety, and insomnia']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032100', 'cui_str': 'Medicinal Plants'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1029148', 'cui_str': 'Zizyphus'}, {'cui': 'C1123049', 'cui_str': 'Jujube'}, {'cui': 'C1033661', 'cui_str': 'Manjack'}, {'cui': 'C0330294', 'cui_str': 'Papaver somniferum'}, {'cui': 'C0015833', 'cui_str': 'Fennel extract'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0331267', 'cui_str': 'Genus Echium'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]",,0.353772,"During the follow-up, Cough, dyspnea, headache, myalgia, anorexia, anxiety, and insomnia improved gradually in both groups, and showed no difference between Zufa syrup and placebo.","[{'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Borujerdi', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Seyed Hasan', 'Initials': 'SH', 'LastName': 'Adeli', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Spiritual Health Research Center, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Mohammadbeigi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Aliasl', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Asghari', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Spiritual Health Research Center, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Hormati', 'Affiliation': 'Gastroenterology and Hepatology Disease Research Center, Qom University of Medical Science, Qom, Iran.'}, {'ForeName': 'Hosein Moradi', 'Initials': 'HM', 'LastName': 'Dehnavi', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Hoseini', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Spiritual Health Research Center, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Asghari', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Qom University of Medical Sciences, Qom, Iran.'}]",Medical gas research,['10.4103/2045-9912.325991']
1975,34674397,A prospective randomized controlled trial of the safety and efficacy of carbon dioxide insufflation compared with room air insufflation during gastric endoscopic submucosal dissection.,"BACKGROUND AND AIM


Carbon dioxide (CO 2  ) insufflation during gastric endoscopic submucosal dissection (GESD) under sedation can be used instead of room air insufflation. Appropriate monitoring of the partial pressure of CO 2  during GESD is necessary due to the impaired respiration. The aim of this study was to assess the safety and efficacy of CO 2  insufflation during GESD compared with conventional room air insufflation.
METHODS


Patients with a gastric epithelial neoplasm or early gastric cancer were enrolled. A total of 76 consecutive patients were randomly assigned to the CO 2  insufflation group (CO 2  group) or the room air insufflation group (air group). The primary outcome was the mean difference of end-tidal CO 2  (EtCO 2  ) between two groups.
RESULTS


The upper bound of the 95% CI for the mean EtCO 2  difference between the two groups before the procedure and at 15, 30 and 45 min after insufflation met the criteria for noninferiority. In a subgroup analysis of patients 70 years and older, the mean difference of EtCO 2  was not significantly different between two groups. However, the air group received more analgesics than the CO 2  group after the procedure (67.6% vs 35.1%, P = 0.005). In addition, in terms of improvement of abdominal pain or bowel gas after 24 h of GESD, CO 2  group showed better results than air group (both P < 0.05).
CONCLUSIONS


CO 2  insufflation during GESD is as safe as using room air, and patients, including elderly patients, receiving CO 2  achieve more rapid relief of abdominal pain and intra-abdominal residual gas during and after the procedure.",2021,"In a subgroup analysis of patients 70 years and older, the mean difference of EtCO 2  was not significantly different between two groups.","['Patients with a gastric epithelial neoplasm or early gastric cancer were enrolled', '76 consecutive patients', 'Gastric Endoscopic Submucosal Dissection']","['CO 2  insufflation group (CO 2  group) or the room air insufflation group (air group', 'Carbon Dioxide Insufflation Compared with Room Air Insufflation', 'Carbon dioxide (CO 2  ) insufflation', 'conventional room air insufflation']","['safety and efficacy', 'mean difference of end-tidal CO 2  (EtCO 2  ', 'EtCO 2  levels', 'abdominal pain or bowel gas']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C1368683', 'cui_str': 'Epithelial neoplasm'}, {'cui': 'C0349530', 'cui_str': 'Early gastric cancer'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0017110', 'cui_str': 'Gas'}]",76.0,0.172527,"In a subgroup analysis of patients 70 years and older, the mean difference of EtCO 2  was not significantly different between two groups.","[{'ForeName': 'Shin Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University College of Medicine, Bucheon, South Korea.'}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University College of Medicine, Bucheon, South Korea.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15718']
1976,34679090,Effectiveness of knowledge brokering and recommendation dissemination for influencing healthcare resource allocation decisions: A cluster randomised controlled implementation trial.,"BACKGROUND


Implementing evidence into clinical practice is a key focus of healthcare improvements to reduce unwarranted variation. Dissemination of evidence-based recommendations and knowledge brokering have emerged as potential strategies to achieve evidence implementation by influencing resource allocation decisions. The aim of this study was to determine the effectiveness of these two research implementation strategies to facilitate evidence-informed healthcare management decisions for the provision of inpatient weekend allied health services.
METHODS AND FINDINGS


This multicentre, single-blinded (data collection and analysis), three-group parallel cluster randomised controlled trial with concealed allocation was conducted in Australian and New Zealand hospitals between February 2018 and January 2020. Clustering and randomisation took place at the organisation level where weekend allied health staffing decisions were made (e.g., network of hospitals or single hospital). Hospital wards were nested within these decision-making structures. Three conditions were compared over a 12-month period: (1) usual practice waitlist control; (2) dissemination of written evidence-based practice recommendations; and (3) access to a webinar-based knowledge broker in addition to the recommendations. The primary outcome was the alignment of weekend allied health provision with practice recommendations at the cluster and ward levels, addressing the adoption, penetration, and fidelity to the recommendations. The secondary outcome was mean hospital length of stay at the ward level. Outcomes were collected at baseline and 12 months later. A total of 45 clusters (n = 833 wards) were randomised to either control (n = 15), recommendation (n = 16), or knowledge broker (n = 14) conditions. Four (9%) did not provide follow-up data, and no adverse events were recorded. No significant effect was found with either implementation strategy for the primary outcome at the cluster level (recommendation versus control β 18.11 [95% CI -8,721.81 to 8,758.02] p = 0.997; knowledge broker versus control β 1.24 [95% CI -6,992.60 to 6,995.07] p = 1.000; recommendation versus knowledge broker β -9.12 [95% CI -3,878.39 to 3,860.16] p = 0.996) or ward level (recommendation versus control β 0.01 [95% CI 0.74 to 0.75] p = 0.983; knowledge broker versus control β -0.12 [95% CI -0.54 to 0.30] p = 0.581; recommendation versus knowledge broker β -0.19 [-1.04 to 0.65] p = 0.651). There was no significant effect between strategies for the secondary outcome at ward level (recommendation versus control β 2.19 [95% CI -1.36 to 5.74] p = 0.219; knowledge broker versus control β -0.55 [95% CI -1.16 to 0.06] p = 0.075; recommendation versus knowledge broker β -3.75 [95% CI -8.33 to 0.82] p = 0.102). None of the control or knowledge broker clusters transitioned to partial or full alignment with the recommendations. Three (20%) of the clusters who only received the written recommendations transitioned from nonalignment to partial alignment. Limitations include underpowering at the cluster level sample due to the grouping of multiple geographically distinct hospitals to avoid contamination.
CONCLUSIONS


Owing to a lack of power at the cluster level, this trial was unable to identify a difference between the knowledge broker strategy and dissemination of recommendations compared with usual practice for the promotion of evidence-informed resource allocation to inpatient weekend allied health services. Future research is needed to determine the interactions between different implementation strategies and healthcare contexts when translating evidence into healthcare practice.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12618000029291.",2021,"No significant effect was found with either implementation strategy for the primary outcome at the cluster level (recommendation versus control β 18.11 [95% CI -8,721.81 to 8,758.02] p = 0.997; knowledge broker versus control β 1.24 [95% CI -6,992.60 to 6,995.07] p = 1.000; recommendation versus knowledge broker β -9.12 [95% CI -3,878.39 to 3,860.16] p = 0.996) or ward level (recommendation versus control β 0.01 [95% CI 0.74 to 0.75] p = 0.983; knowledge broker versus control β","['Australian and New Zealand hospitals between February 2018 and January 2020', 'A total of 45 clusters (n = 833 wards']","['knowledge brokering and recommendation dissemination', 'usual practice waitlist control; (2) dissemination of written evidence-based practice recommendations; and (3) access to a webinar-based knowledge broker in addition to the recommendations']","['alignment of weekend allied health provision with practice recommendations at the cluster and ward levels, addressing the adoption, penetration, and fidelity to the recommendations', 'mean hospital length of stay at the ward level']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C5191298', 'cui_str': '833'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0022752', 'cui_str': 'Knowledge Bases (Computer)'}, {'cui': 'C0401816', 'cui_str': 'Broker'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.419488,"No significant effect was found with either implementation strategy for the primary outcome at the cluster level (recommendation versus control β 18.11 [95% CI -8,721.81 to 8,758.02] p = 0.997; knowledge broker versus control β 1.24 [95% CI -6,992.60 to 6,995.07] p = 1.000; recommendation versus knowledge broker β -9.12 [95% CI -3,878.39 to 3,860.16] p = 0.996) or ward level (recommendation versus control β 0.01 [95% CI 0.74 to 0.75] p = 0.983; knowledge broker versus control β","[{'ForeName': 'Mitchell N', 'Initials': 'MN', 'LastName': 'Sarkies', 'Affiliation': 'Centre for Healthcare Resilience and Implementation Science, Australian Institute of Health Innovation, Faculty of Medicine, Health and Human Sciences, Macquarie University, New South Wales, Australia.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Robins', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Victoria, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Jepson', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Victoria, Australia.'}, {'ForeName': 'Cylie M', 'Initials': 'CM', 'LastName': 'Williams', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Victoria, Australia.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'La Trobe Centre for Sport and Exercise Medicine Research, La Trobe University, Victoria, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': ""O'Brien"", 'Affiliation': 'Department Occupational Therapy, School of Primary and Allied Health Care, Monash University, Victoria, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Department of Social Work and Human Services, School of Arts, Federation University Australia, Victoria, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bardoel', 'Affiliation': 'Department of Management and Marketing, Swinburne University of Technology, Victoria, Australia.'}, {'ForeName': 'Meg E', 'Initials': 'ME', 'LastName': 'Morris', 'Affiliation': 'La Trobe Centre for Sport and Exercise Medicine Research, La Trobe University, Victoria, Australia.'}, {'ForeName': 'Leeanne M', 'Initials': 'LM', 'LastName': 'Carey', 'Affiliation': 'Occupational Therapy, School of Allied Health, Human Services and Sport, La Trobe University, Victoria, Australia.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'Department of Allergy, Immunology and Respiratory Medicine, Monash University, Victoria, Australia.'}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Long', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Victoria, Australia.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Victoria, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003833']
1977,34662695,Effect of hyperbaric oxygen therapy and Tomatis sound therapy in children with autism spectrum disorder.,"Many therapeutic and dietary regimens have been studied for children with autism spectrum disorder (ASD) in the last three decades. We aimed to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) and Tomatis sound therapy (TST) in an Egyptian cohort of children with ASD. This study was a prospective, open label, randomized interventional clinical trial. One hundred forty-six children with ASD with no previous rehabilitation therapy were enrolled in our study. Patients were randomly divided into four groups: the first group received hyperbaric oxygen therapy, the second group received Tomatis sound therapy, the third group received a combination of both modalities, and the fourth group, the control group, received no intervention. We found that the combination of Tomatis sound therapy with hyperbaric oxygen therapy had a superior effect in improving autism symptoms than each intervention alone (CARS after therapy 35.04 ± 13.38 versus 49.34 ± 17.54 before the intervention, p < 0.001). The combination of both modalities may be helpful for children with ASD. The most distinctive evidence that supports the use of combination therapy for ASD is still controversial; however, our study provides some evidence of the benefit of combination therapy for children with ASD. Future studies should use a more sophisticated research design and begin by finding a consistent baseline measure that can be used to evaluate the effects of these therapies for ASD.",2021,"We found that the combination of Tomatis sound therapy with hyperbaric oxygen therapy had a superior effect in improving autism symptoms than each intervention alone (CARS after therapy 35.04 ± 13.38 versus 49.34 ± 17.54 before the intervention, p < 0.001).","['children with autism spectrum disorder (ASD', 'children with autism spectrum disorder', 'children with ASD', 'Egyptian cohort of children with ASD', 'One hundred forty-six children with ASD with no previous rehabilitation therapy were enrolled in our study']","['hyperbaric oxygen therapy (HBOT) and Tomatis sound therapy (TST', 'hyperbaric oxygen therapy, the second group received Tomatis sound therapy, the third group received a combination of both modalities, and the fourth group, the control group, received no intervention', 'hyperbaric oxygen therapy and Tomatis sound therapy', 'hyperbaric oxygen therapy']",['autism symptoms'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",146.0,0.0150511,"We found that the combination of Tomatis sound therapy with hyperbaric oxygen therapy had a superior effect in improving autism symptoms than each intervention alone (CARS after therapy 35.04 ± 13.38 versus 49.34 ± 17.54 before the intervention, p < 0.001).","[{'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'El-Tellawy', 'Affiliation': 'Departments of Pediatrics, College of Medicine, Jouf University, Sakaka, Saudi Arabia; Departments of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmad Roshdy', 'Initials': 'AR', 'LastName': 'Ahmad', 'Affiliation': 'Departments of Pediatrics, College of Medicine, Jouf University, Sakaka, Saudi Arabia; Departments of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Saad', 'Affiliation': 'Departments of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt; Department of Pediatrics, Faculty of Medicine, Alrayan Colleges, Madinah, Saudi Arabia. Electronic address: khaled.ali@med.au.edu.eg.'}, {'ForeName': 'Thamer A M', 'Initials': 'TAM', 'LastName': 'Alruwaili', 'Affiliation': 'Departments of Pediatrics, College of Medicine, Jouf University, Sakaka, Saudi Arabia.'}, {'ForeName': 'Inas M', 'Initials': 'IM', 'LastName': 'AbdelMoneim', 'Affiliation': 'Department of Psychology, Speech, and Special Needs, Faculty of Arts, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Islam', 'Initials': 'I', 'LastName': 'Shaaban', 'Affiliation': 'Department of Neuropsychiatry, Faculty of Medicine, Azhar University, Egypt.'}, {'ForeName': 'Ahmed Khalid M', 'Initials': 'AKM', 'LastName': 'Alinad', 'Affiliation': 'College of Medicine, Jouf University, Sakaka, Saudi Arabia.'}, {'ForeName': 'Saqer Bulayhid H', 'Initials': 'SBH', 'LastName': 'Albulayhid', 'Affiliation': 'College of Medicine, Jouf University, Sakaka, Saudi Arabia.'}, {'ForeName': 'Shaimaa M', 'Initials': 'SM', 'LastName': 'Khalaf', 'Affiliation': 'Departments of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2021.110457']
1978,34676658,The importance of addressing multiple risk markers in type 2 diabetes: Results from the LEADER and SUSTAIN 6 trials.,"AIMS


To investigate to what extent multiple risk marker improvements confer lower risk of cardiovascular and kidney complications in a contemporary type 2 diabetes population.
MATERIALS AND METHODS


Post-hoc analysis of the LEADER (n = 8638; median follow-up 3.8 years) and SUSTAIN 6 (n = 3040; median follow-up 2.1 years) cardiovascular outcome trials. Participants were those with baseline and year-1 assessment of at least one of the parameters of interest; we pooled the liraglutide-/semaglutide- and placebo-treated groups and categorized them by number of risk markers with clinically relevant improvements after 1 year of study participation. We investigated risk of major adverse cardiovascular events (MACE), expanded MACE, cardiovascular death and nephropathy. Predefined clinically relevant changes: body weight loss ≥5%; reductions in: glycated haemoglobin ≥1%, systolic blood pressure ≥5 mmHg and low-density lipoprotein cholesterol ≥0.5 mmol/L; estimated glomerular filtration rate change ≥0 ml/min/1.73 m 2  and urinary albumin-to-creatinine ratio change ≥30% of baseline value. Cox regression analysed risk of outcomes adjusted for baseline risk marker levels and treatment group and stratified by trial.
RESULTS


Participants with two, three, or four or more improved risk markers versus participants with no risk marker improvement had reduced risk of expanded MACE [hazard ratio (95% confidence interval) 0.80 (0.67-0.96); 0.80 (0.66-0.97); 0.82 (0.66-1.02)], cardiovascular death [0.66 (0.45-0.96), 0.67 (0.45-0.99), 0.60 (0.38-0.94)] and nephropathy [0.71 (0.52-0.97), 0.48 (0.34-0.68), 0.43 (0.29-0.65)].
CONCLUSIONS


In persons with type 2 diabetes, improvements in ≥2 risk markers conferred cardiovascular risk reduction versus none or one improved risk marker. The nephropathy risk decreased with improvement in more risk markers. These findings stress the importance of multifactorial interventions targeting all risk markers.",2021,"In persons with type 2 diabetes, improvements in ≥2 risk markers conferred cardiovascular risk reduction versus none or one improved risk marker.","['8638; median follow-up 3.8\u2009years) and SUSTAIN 6 (n\xa0=\xa03040; median follow-up 2.1\u2009years) cardiovascular outcome trials', 'Post-hoc analysis of the LEADER (n\xa0', 'type 2 diabetes']",['liraglutide-/semaglutide- and placebo'],"['glycated haemoglobin ≥1%, systolic blood pressure ≥5', 'glomerular filtration rate change', 'risk of major adverse cardiovascular events (MACE), expanded MACE, cardiovascular death and nephropathy', 'nephropathy risk', 'urinary albumin-to-creatinine ratio change', 'cardiovascular death', 'reduced risk of expanded MACE [hazard ratio', 'risk markers', 'cardiovascular risk reduction']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.334067,"In persons with type 2 diabetes, improvements in ≥2 risk markers conferred cardiovascular risk reduction versus none or one improved risk marker.","[{'ForeName': 'Emilie H', 'Initials': 'EH', 'LastName': 'Zobel', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Bernt Johan', 'Initials': 'BJ', 'LastName': 'von Scholten', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Tine W', 'Initials': 'TW', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Wolthers', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14578']
1979,34674368,A randomized double-blind placebo-controlled trial of the effectiveness of melatonin on neurocognition and sleep in survivors of childhood cancer.,"BACKGROUND


Adult survivors of childhood cancer are at risk of developing sleep and neurocognitive problems, yet few efficacious interventions exist targeting these prevalent late effects. Melatonin has known sleep-promoting effects; however, it has not been well studied among childhood cancer survivors.
METHOD


Survivors (n = 580; mean age = 33.5 years; 26 years post-diagnosis) from the St. Jude Lifetime Cohort were randomized (1:1) to a six-month double-blind placebo-controlled trial of 3 mg time-release melatonin within three strata (stratum 1: neurocognitive impairment only; stratum 2: neurocognitive and sleep impairment; stratum 3: sleep impairment only). Neurocognitive performance was assessed at baseline and post-intervention using standardized measures. Sleep was assessed via self-report and actigraphy. Independent sample t tests compared mean change scores from baseline to six months. Post-hoc analyses compared the prevalence of clinically significant treatment responders among melatonin and placebo conditions within and across strata.
RESULTS


Intent-to-treat analyses revealed no statistically significant differences in neurocognitive performance or sleep from baseline to post-intervention. However, among survivors with neurocognitive impairment only, a larger proportion randomized to melatonin versus placebo demonstrated a treatment response for visuomotor speed (63% vs 41%, P = 0.02) and nonverbal reasoning (46% vs 28%, P = 0.04). Among survivors with sleep impairment only, a larger proportion treated with melatonin demonstrated a treatment response for shifting attention (44% vs 28%, P = 0.05), short-term memory (39% vs 19%, P = 0.01), and actigraphy-assessed sleep duration (47% vs 29%, P = 0.05).
CONCLUSION


Melatonin was not associated with improved neurocognitive performance or sleep in our intent-to-treat analyses; however, a subset of survivors demonstrated a clinically significant treatment response.",2021,"Melatonin was not associated with improved neurocognitive performance or sleep in our intent-to-treat analyses; however, a subset of survivors demonstrated a clinically significant treatment response.","['Survivors (n\xa0', 'mean age\xa0=\xa033.5 years; 26 years post-diagnosis) from the St. Jude Lifetime Cohort', '580', 'survivors of childhood cancer', 'childhood cancer survivors']","['Melatonin', 'placebo', 'placebo-controlled trial of 3\xa0mg time-release melatonin within three strata (stratum 1: neurocognitive impairment only; stratum 2: neurocognitive and sleep impairment; stratum 3: sleep impairment only', 'melatonin']","['Neurocognitive performance', 'visuomotor speed', 'Sleep', 'actigraphy-assessed sleep duration', 'short-term memory', 'nonverbal reasoning', 'neurocognition and sleep', 'neurocognitive performance or sleep']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C4505050', 'cui_str': 'Survivors of Childhood Cancer'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]",580.0,0.493868,"Melatonin was not associated with improved neurocognitive performance or sleep in our intent-to-treat analyses; however, a subset of survivors demonstrated a clinically significant treatment response.","[{'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Lubas', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Belinda N', 'Initials': 'BN', 'LastName': 'Mandrell', 'Affiliation': ""Department of Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Greene', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Carrie R', 'Initials': 'CR', 'LastName': 'Howell', 'Affiliation': 'Department of Medicine, Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Robbin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Cara I', 'Initials': 'CI', 'LastName': 'Kimberg', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Chenghong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Kirsten K', 'Initials': 'KK', 'LastName': 'Ness', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Deo Kumar', 'Initials': 'DK', 'LastName': 'Srivastava', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Leslie L', 'Initials': 'LL', 'LastName': 'Robison', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Krull', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Tara M', 'Initials': 'TM', 'LastName': 'Brinkman', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.""}]",Pediatric blood & cancer,['10.1002/pbc.29393']
1980,34680123,"Biomolecules in Dental Applications: Randomized, Controlled Clinical Trial Evaluating the Influence of Hyaluronic Acid Adjunctive Therapy on Clinical Parameters of Moderate Periodontitis.","The biological activity of hyaluronic acid (HA) has been well-researched during the past decades; however, there are few randomized, controlled trials of its clinical effects in periodontal therapy. The purpose of this study was to evaluate the effect of hyaluronic acid on the principal parameters of periodontal healing. A specific, commercially available formulation designed and registered for professional dental application, composed of 16 mg/mL of cross-linked and 2 mg/mL of non-cross-linked HA, was used as an adjunctive to non-surgical periodontal therapy, and clinical parameters were evaluated after 3 months. The addition of HA to periodontal therapy demonstrated more favorable clinical results regarding reduction in inflammation, measured by bleeding on probing (-6% compared to the control group) and gain in periodontal attachment (1 mm more than control group), while it had no effect on probing depth reduction. No side effects were reported. Our study demonstrated that HA is a safe and easy-to-use biological agent; due to its wide array of properties, it may significantly improve the results of periodontal therapy. However, more long-term studies are needed to investigate whether these favorable effects remain over time.",2021,No side effects were reported.,"['Biomolecules in Dental Applications', 'Moderate Periodontitis']","['HA', 'hyaluronic acid (HA', 'hyaluronic acid', 'Hyaluronic Acid Adjunctive Therapy']",['gain in periodontal attachment'],"[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",,0.0293201,No side effects were reported.,"[{'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Olszewska-Czyz', 'Affiliation': 'Department of Periodontology and Oral Pathology, Dental Institute, Medical Faculty, Jagielonian University, 31155 Krakow, Poland.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Kralik', 'Affiliation': 'Department of Medical Statistics and Medical Informatics, Medical Faculty Osijek, University Josip Juraj Strossmayer of Osijek, 31000 Osijek, Croatia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Prpic', 'Affiliation': 'Department of Oral Medicine and Periodontology, Faculty of Dental Medicine, University of Rijeka, 51000 Rijeka, Croatia.'}]",Biomolecules,['10.3390/biom11101491']
1981,34686649,Repetitive Transcranial Magnetic Stimulation (rTMS) Modulates Thyroid Hormones Level and Cognition in the Recovery Stage of Stroke Patients with Cognitive Dysfunction.,"BACKGROUND This single-center study aimed to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) on modulation of thyroid hormone levels and cognition in the recovery stage of patients with cognitive dysfunction following stroke. MATERIAL AND METHODS Seventy post-stroke patients who had cognitive impairment were randomly assigned to either the rTMS group or the control (sham) group. Both groups were administered basic treatment, with the rTMS group receiving rTMS (1 Hz, 90% MT, 1000 pulse/20 min, once a day for 5 days, for a total of 20 times), the stimulation site was the contralateral dorsolateral prefrontal cortex (DLPFC), and the sham group receiving sham stimulation which had the same stimulation parameters and site, except that the coil plane was placed perpendicular to the surface of the scalp. Cognitive function assessment and thyroid function tests were performed before and after 4 weeks of treatment. RESULTS Serum levels of triiodothyronine (T3), free triiodothyronine (FT3), and thyroid stimulating hormone (TSH) showed a positive correlation with Montreal Cognitive Assessment (MoCA) scale score of stroke patients in the recovery phase. The post-treatment change in the scores of MoCA and Modified Barthel Index (MBI) and scores of 3 cognitive domains (visuospatial function, memory, and attention), as well as serum T3, FT3, and TSH levels, were improved more significantly in the rTMS group, and T3 and FT3 levels significantly affected the MoCA scores within the reference range. CONCLUSIONS Serum T3, FT3, and TSH levels of stroke patients in the recovery phase were positively correlated with MoCA score. rTMS increased T3, FT3, and TSH levels and also improved MoCA and MBI of patients in the recovery phase of stroke.",2021,"rTMS increased T3, FT3, and TSH levels and also improved MoCA and MBI of patients in the recovery phase of stroke.","['Stroke Patients with Cognitive Dysfunction', 'Seventy post-stroke patients who had cognitive impairment', 'patients with cognitive dysfunction following stroke']","['sham group receiving sham stimulation', 'rTMS group receiving rTMS', 'rTMS', 'Repetitive Transcranial Magnetic Stimulation (rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['Cognitive function assessment and thyroid function tests', 'scores of MoCA and Modified Barthel Index (MBI) and scores of 3 cognitive domains (visuospatial function, memory, and attention), as well as serum T3, FT3, and TSH levels', 'Montreal Cognitive Assessment (MoCA) scale score', 'Serum T3, FT3, and TSH levels', 'Serum levels of triiodothyronine (T3), free triiodothyronine (FT3), and thyroid stimulating hormone (TSH', 'rTMS increased T3, FT3, and TSH levels']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040130', 'cui_str': 'Thyroid panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0370097', 'cui_str': 'Free triiodothyronine'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",70.0,0.0294136,"rTMS increased T3, FT3, and TSH levels and also improved MoCA and MBI of patients in the recovery phase of stroke.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, Shijiazhuang People's Hospital, Shijiazhuang, Hebei, China (mainland).""}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Rehabilitation Medicine, Shijiazhuang People's Hospital, Shijiazhuang, Hebei, China (mainland).""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing and Rehabilitation, North China University of Science and Technology, Tangshan, Hebei, China (mainland).'}, {'ForeName': 'Wan-Ying', 'Initials': 'WY', 'LastName': 'Shi', 'Affiliation': ""Department of Neurology, Shijiazhuang People's Hospital, Shijiazhuang, Hebei, China (mainland).""}, {'ForeName': 'Hao-Nan', 'Initials': 'HN', 'LastName': 'Mei', 'Affiliation': 'School of Nursing and Rehabilitation, North China University of Science and Technology, Tangshan, Hebei, China (mainland).'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': ""Department of Rehabilitation Medicine, Shijiazhuang People's Hospital, Shijiazhuang, Hebei, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.931914']
1982,34659683,Computed Tomography Image under Three-Dimensional Reconstruction Algorithm Based in Diagnosis of Renal Tumors and Retroperitoneal Laparoscopic Partial Nephrectomy.,"This study was to explore the clinical application value of computed tomography (CT) images based on a three-dimensional (3D) reconstruction algorithm for laparoscopic partial nephrectomy (LPN) in patients with renal tumors. 30 cases of renal cell carcinoma (RCC) patients admitted to the hospital were selected as the research objects and were rolled into two groups using a random table method. The patients who received PLN under the three-dimensional reconstruction and laparoscopic technique were included in the experimental group (group A), and the patients who received LPN using CT images only were included in the control group (group B). In addition, the treatment results of the two groups of patients were compared and analyzed.  Results . The effective rate of the established model was 93.3%; the total renal arteriovenous variability of group A (13.3%) was higher than that of group B (6.7%), and the operation time (131.5 ± 32.1 minutes) was much lower than that of group B (158.7 ± 36.2 minutes), showing statistical significance ( P  < 0.05).  Conclusion . CT images based on 3D reconstruction algorithms had high clinical application value for LPN in patients with renal tumors, which could improve the efficiency and safety of LPN.",2021,"The effective rate of the established model was 93.3%; the total renal arteriovenous variability of group A (13.3%) was higher than that of group B (6.7%), and the operation time (131.5 ± 32.1 minutes) was much lower than that of group B (158.7 ± 36.2 minutes), showing statistical significance ( P  < 0.05).  ","['30 cases of renal cell carcinoma (RCC) patients admitted to the hospital', 'patients with renal tumors']","['LPN using CT', 'Computed Tomography Image under Three-Dimensional Reconstruction Algorithm', 'computed tomography (CT) images based on a three-dimensional (3D) reconstruction algorithm for laparoscopic partial nephrectomy (LPN', 'PLN']","['effective rate', 'total renal arteriovenous variability', 'efficiency and safety of LPN', 'operation time']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022665', 'cui_str': 'Neoplasm of kidney'}]","[{'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0170827,"The effective rate of the established model was 93.3%; the total renal arteriovenous variability of group A (13.3%) was higher than that of group B (6.7%), and the operation time (131.5 ± 32.1 minutes) was much lower than that of group B (158.7 ± 36.2 minutes), showing statistical significance ( P  < 0.05).  ","[{'ForeName': 'Haijie', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Imaging, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Yin', 'Affiliation': 'School of Information Engineering, Shenzhen University, Shenzhen 518000, China.'}, {'ForeName': 'Liyang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Imaging, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Anqi', 'Initials': 'A', 'LastName': 'Qi', 'Affiliation': 'Department of Imaging, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Cui', 'Affiliation': 'Department of Imaging, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Imaging, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Wen', 'Affiliation': 'Department of Imaging, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}]",Journal of healthcare engineering,['10.1155/2021/3066930']
1983,34678709,Targeting risk factors for inhibited preschool children: An anxiety prevention program.,"OBJECTIVE


Children with a behaviorally inhibited temperament during early childhood have been shown to have an increased risk for developing anxiety disorders. This study evaluated the efficacy of an anxiety prevention program aimed at reducing the risk of anxiety in behaviorally inhibited preschool children.
METHOD


Participants were 86 children aged 41-57 months and their mothers. Children were selected if their mothers reported high levels of child behavioral inhibition on a screening measure. Participants were randomly allocated to a nine-session intervention or a waitlist control condition. Mothers and children both participated in the intervention.
RESULTS


At follow-up, the intervention group had significantly fewer clinician-rated child anxiety disorders and fewer mother-reported child anxiety symptoms than at baseline but this change was not significantly different to the change seen in the waitlist control group.
CONCLUSIONS


On average, across the course of the study, anxiety decreased in all children irrespective of group. A number of potential reasons for this are discussed along with implications for research and clinical practice.",2021,"At follow-up, the intervention group had significantly fewer clinician-rated child anxiety disorders and fewer mother-reported child anxiety symptoms than at baseline but this change was not significantly different to the change seen in the waitlist control group.
","['preschool children', 'Children with a behaviorally inhibited temperament during early childhood', 'Participants were 86 children aged 41-57 months and their mothers', 'Mothers and children both participated in the intervention']","['nine-session intervention or a waitlist control condition', 'anxiety prevention program']","['anxiety', 'child behavioral inhibition', 'risk of anxiety', 'child anxiety symptoms', 'clinician-rated child anxiety disorders']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]",86.0,0.0114164,"At follow-up, the intervention group had significantly fewer clinician-rated child anxiety disorders and fewer mother-reported child anxiety symptoms than at baseline but this change was not significantly different to the change seen in the waitlist control group.
","[{'ForeName': 'Frances L', 'Initials': 'FL', 'LastName': 'Doyle', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, Australia; Western Sydney University, The MARCS Institute for Brain, Behaviour and Development, Penrith, NSW, Australia.'}, {'ForeName': 'Helen F', 'Initials': 'HF', 'LastName': 'Dodd', 'Affiliation': 'ChYMe, College of Medicine and Health, University of Exeter, UK. Electronic address: h.dodd@exeter.ac.uk.'}, {'ForeName': 'Talia M', 'Initials': 'TM', 'LastName': 'Morris', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, Australia.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Lazarus', 'Affiliation': 'Knox Grammar Preparatory School, Sydney, NSW, Australia.'}, {'ForeName': 'Yulisha', 'Initials': 'Y', 'LastName': 'Byrow', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, Australia; School of Psychology, University of New South Wales, NSW, Australia.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hudson', 'Affiliation': 'Black Dog Institute, University of New South Wales Randwick, NSW, Australia; Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, Australia. Electronic address: jennie.hudson@unsw.edu.au.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103982']
1984,34671752,The longer-term effects of access to HIV self-tests on HIV testing frequency in high-risk gay and bisexual men: follow-up data from a randomised controlled trial.,"Background


A wait-list randomised controlled trial in Australia (FORTH) in high-risk gay and bisexual men (GBM) showed access to free HIV self-tests (HIVSTs) doubled the frequency of HIV testing in year 1 to reach guideline recommended levels of 4 tests per year, compared to two tests per year in the standard-care arm (facility-based testing). In year 2, men in both arms had access to HIVSTs. We assessed if the effect was maintained for a further 12 months.
Methods


Participants included GBM reporting condomless anal intercourse or > 5 male partners in the past 3 months. We included men who had completed at least one survey in both year 1 and 2 and calculated the mean tests per person, based on the validated self-report and clinic records. We used Poisson regression and random effects Poisson regression models to compare the overall testing frequency by study arm, year and testing modality (HIVST/facility-based test).
Findings


Overall, 362 men completed at least one survey in year 1 and 343 in year 2. Among men in the intervention arm (access to HIVSTs in both years), the mean number of HIV tests in year 2 (3⋅7 overall, 2⋅3 facility-based tests, 1⋅4 HIVSTs) was lower compared to year 1 (4⋅1 overall, 1⋅7 facility-based tests, 2⋅4 HIVSTs) (RR:0⋅84, 95% CI:0⋅75-0⋅95, p=0⋅002), but higher than the standard-care arm in year 1 (2⋅0 overall, RR:1⋅71, 95% CI:1⋅48-1.97, p<0⋅001). Findings were not different when stratified by sociodemographic characteristics or recent high risk sexual history.
Interpretation


In year 2, fewer HIVSTs were used on average compared to year 1, but access to free HIVSTs enabled more men to maintain higher HIV testing frequency, compared with facility-based testing only. HIV self-testing should be a key component of HIV testing and prevention strategies.
Funding


This work was supported by grant 568971 from the National Health and Medical Research Council of Australia.",2021,"In year 2, fewer HIVSTs were used on average compared to year 1, but access to free HIVSTs enabled more men to maintain higher HIV testing frequency, compared with facility-based testing only.","['high-risk gay and bisexual men', 'high-risk gay and bisexual men (GBM', '362 men completed at least one survey in year 1 and 343 in year 2', 'men who had completed at least one survey in both year 1 and 2 and calculated the mean tests per person, based on the validated self-report and clinic records']",['HIV self-tests'],"['mean number of HIV tests', 'HIV testing frequency']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.14837,"In year 2, fewer HIVSTs were used on average compared to year 1, but access to free HIVSTs enabled more men to maintain higher HIV testing frequency, compared with facility-based testing only.","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Muhammad S', 'Initials': 'MS', 'LastName': 'Jamil', 'Affiliation': 'Global HIV, Hepatitis and STI Programme, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Kirsty S', 'Initials': 'KS', 'LastName': 'Smith', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Tanya L', 'Initials': 'TL', 'LastName': 'Applegate', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Prestage', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Holt', 'Affiliation': 'Centre for Social Research in Health, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Keen', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Bavinton', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Damian P', 'Initials': 'DP', 'LastName': 'Conway', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Wand', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'McNulty', 'Affiliation': 'Sydney Sexual Health Centre, South Eastern Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Cairns Sexual Health Service, Cairns North, QLD, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Vaughan', 'Affiliation': 'ACON, Sydney, NSW, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Batrouney', 'Affiliation': 'Thorne Harbour Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Wiseman', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Fairley', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Grulich', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kaldor', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Guy', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}]",The Lancet regional health. Western Pacific,['10.1016/j.lanwpc.2021.100214']
1985,34656194,Examining the Relation Between Technical and Global Competence in Two Treatments for Youth Anxiety.,"Although technical (quality of delivering techniques from a specific treatment) and global (general clinical expertise) competence are believed to be important ingredients of successful psychosocial treatment with youth, there have been few empirical efforts to measure both dimensions. Efforts to understand the role that each competence dimension plays in the process and outcome of youth treatment starts with determining whether the dimensions can be measured separately. This study examined whether scores from measures designed to assess technical and global competence were distinct. Treatment sessions (N = 603) from 38 youths (M age = 9.84 years, SD = 1.65; 60.5% White; 52.6% male) treated for primary anxiety problems within a randomized effectiveness trial were coded. Four coders used observational measures designed to assess technical competence, global competence, protocol adherence, and the alliance. Mean item interrater reliability was .70 (SD = .09) for technical competence and .66 (SD = .05) for global competence. While most components of global competence were distinct from technical competence scores, two components showed redundancy (r > .70). Scores on both competence measures were empirically distinct (r < .70) from scores on measures of protocol adherence and the alliance. Although the measures did not fully distinguish between technical and global competence, our findings do indicate that some components of technical and global competence may provide unique information about competence.",2021,"While most components of global competence were distinct from technical competence scores, two components showed redundancy (r > .70).","['38 youths (M age\u202f=\u202f9.84 years, SD\u202f=\u202f1.65; 60.5% White; 52.6% male) treated for primary anxiety problems within a randomized effectiveness trial were coded']",[],"['Mean item interrater reliability', 'technical competence, global competence, protocol adherence, and the alliance']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0404864,"While most components of global competence were distinct from technical competence scores, two components showed redundancy (r > .70).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Cecilione', 'Affiliation': 'Virginia Commonwealth University. Electronic address: jcecilione@vcu.edu.'}, {'ForeName': 'Bryce D', 'Initials': 'BD', 'LastName': 'McLeod', 'Affiliation': 'Virginia Commonwealth University.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Southam-Gerow', 'Affiliation': 'Virginia Commonwealth University.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weisz', 'Affiliation': 'Harvard University.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Chorpita', 'Affiliation': 'University of California, Los Angeles.'}]",Behavior therapy,['10.1016/j.beth.2021.03.009']
1986,34659682,Effect Analysis of Epidural Anesthesia with 0.4% Ropivacaine in Transforaminal Endoscopic Surgery.,"Background


Epidural anesthesia used in percutaneous endoscopic lumber discectomy (PELD) has the risk of complete neurotactile block. Patients cannot timely respond to the operator when the nerve is touched by mistake, so the potential risk of nerve injury cannot be avoided. According to pharmacodynamics, with the decrease of local anesthetic concentration, the nerve tactile gradually recovered; however, the analgesic effect also gradually weakened. Therefore, it is necessary to explore an appropriate concentration of local anesthetics that can keep the patients' nerve touch without pain. By comparing the advantages and disadvantages of 0.4% ropivacaine epidural anesthesia, local anesthesia and intravenous anesthesia on intraoperative circulation fluctuation, the incidence of salvage analgesia and the incidence of nerve non-touch, the feasibility of using low concentration epidural anesthesia in PELD to obtain enough analgesia and avoid the risk of nerve injury was confirmed.
Methods


153 cases of intervertebral foramen surgery from October 2017 to January 2020 were selected and divided into local anesthesia group (LA group), 0.4% ropivacaine epidural anesthesia group (EA group), and intravenous anesthesia group (IVA group) according to different anesthesia methods. The changes of blood pressure and heart rate, the incidence of rescue analgesia and nerve root non-touch were compared among the three groups.
Results


The difference of map peak value among the three groups was statistically significant ( P  < 0.001); pairwise comparison showed that the map peak value of the LA group was higher than that of the EA group ( P  < 0.001) and IVA group ( P  < 0.001), but there was no statistical significance between the EA group and IVA group. The difference of HR peak value among the three groups was statistically significant; pairwise comparison showed that the HR peak value of the LA group was higher than that of the EA group ( P  < 0.001) and IVA group ( P  < 0.001), but there was no statistical significance between the EA group and IVA group. There was significant difference in the incidence of intraoperative hypertension among the three groups ( P  < 0.05); pairwise comparison showed that the incidence of intraoperative hypertension in the EA group was lower than that in the LA group ( P  < 0.05), while there was no significant difference between the IVA group, EA group, and LA group. There was significant difference in the incidence of rescue analgesia among the three groups ( P  < 0.01); pairwise comparison showed that the incidence of rescue analgesia in the EA group was lower than that in the LA group ( P  < 0.05) and IVA group ( P  < 0.05), but there was no significant difference between the LA group and IVA group. Due to the different analgesic mechanisms of the three anesthesia methods, local anesthesia and intravenous anesthesia do not cause the loss of nerve tactile, while the incidence of nerve tactile in 0.4% ropivacaine epidural anesthesia is only 2.4%, which is still satisfactory.
Conclusion


Epidural anesthesia with 0.4% ropivacaine is a better anesthesia method for PELD. It not only has a low incidence of non-tactile nerve, but also has perfect analgesia and more stable intraoperative circulation.",2021,"There was significant difference in the incidence of rescue analgesia among the three groups ( P  < 0.01); pairwise comparison showed that the incidence of rescue analgesia in the EA group was lower than that in the LA group ( P  < 0.05) and IVA group ( P  < 0.05), but there was no significant difference between the LA group and IVA group.","['Transforaminal Endoscopic Surgery', '153 cases of intervertebral foramen surgery from October 2017 to January 2020']","['ropivacaine', 'Epidural Anesthesia with 0.4% Ropivacaine', 'percutaneous endoscopic lumber discectomy (PELD', 'local anesthesia group (LA group), 0.4% ropivacaine epidural anesthesia group (EA group), and intravenous anesthesia group (IVA group) according to different anesthesia methods', 'LA', 'ropivacaine epidural anesthesia, local anesthesia and intravenous anesthesia']","['incidence of rescue analgesia', 'blood pressure and heart rate, the incidence of rescue analgesia and nerve root non-touch', 'analgesic effect', 'incidence of intraoperative hypertension', 'local anesthetic concentration', 'HR peak value']","[{'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0223085', 'cui_str': 'Structure of intervertebral foramen'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0228084', 'cui_str': 'Nerve root structure'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1328500', 'cui_str': 'Intraoperative hypertension'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0420232,"There was significant difference in the incidence of rescue analgesia among the three groups ( P  < 0.01); pairwise comparison showed that the incidence of rescue analgesia in the EA group was lower than that in the LA group ( P  < 0.05) and IVA group ( P  < 0.05), but there was no significant difference between the LA group and IVA group.","[{'ForeName': 'Bingwei', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Pain, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China.'}, {'ForeName': 'Zhimei', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Anesthesiology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'Department of Pain, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}]",Journal of healthcare engineering,['10.1155/2021/2929843']
1987,34676663,"Efficacy and safety of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis: a global phase 3, randomised, placebo-controlled superiority study (VANISH 306).","OBJECTIVE


To evaluate the efficacy and safety of ibrexafungerp versus placebo for acute vulvovaginal candidiasis (VVC) treatment.
DESIGN


Global phase 3, randomised, placebo-controlled superiority study.
SETTING


Study sites in the USA (n = 19) and Bulgaria (n = 18).
POPULATION


Female patients aged ≥12 years with acute VVC and a vulvovaginal signs and symptoms (VSS) score ≥4 at baseline.
METHODS


Patients were randomly assigned 2:1 to ibrexafungerp (300 mg twice for 1 day) or placebo.
MAIN OUTCOME MEASURES


The primary endpoint was the percentage of patients with a clinical cure (VSS = 0) at the test-of-cure visit (day 11 ± 3). Secondary endpoints included percentages of patients with mycological eradication, clinical cure and mycological eradication (overall success), clinical improvement (VSS ≤1) at test-of-cure visit, and complete resolution of symptoms at follow-up visit (day 25 ± 4).
RESULTS


At the test-of-cure visit, patients receiving ibrexafungerp had significantly higher rates of clinical cure (63.3% [119/188] versus 44.0% [37/84]; P = 0.007), mycological eradication (58.5% [110/188] versus 29.8% [25/84]; P < 0.001), overall success (46.1% [82/188] versus 28.4% [23/84]; P = 0.022) and clinical improvement (72.3% [136/188] versus 54.8% [46/84]; P = 0.01) versus those receiving placebo. Symptom resolution was sustained and further increased with ibrexafungerp (73.9%) versus placebo (52.4%) at follow-up (P = 0.001). Ibrexafungerp was generally well tolerated. Adverse events were primarily gastrointestinal and were mild to moderate in severity.
CONCLUSIONS


Ibrexafungerp demonstrated statistical superiority over placebo for the primary and secondary endpoints. Ibrexafungerp is a promising novel, well-tolerated and effective oral 1-day treatment for acute VVC.
TWEETABLE ABSTRACT


Ibrexafungerp is statistically superior to placebo for the treatment of vulvovaginal candidiasis.",2021,"Secondary endpoints included percentages of patients with mycological eradication, clinical cure and mycological eradication (overall success), clinical improvement (VSS≤1) at test-of-cure visit, and complete resolution of symptoms at follow-up visit (day 25±4).
","['acute vulvovaginal candidiasis (VVC) treatment', 'acute vulvovaginal candidiasis', 'Study sites in the United States (n=19) and Bulgaria (n=18', 'Patients', 'Female patients aged ≥12 years with acute VVC and a vulvovaginal signs and symptoms (VSS) score ≥4 at baseline']","['ibrexafungerp vs placebo', 'ibrexafungerp', 'placebo', 'oral ibrexafungerp']","['tolerated', 'clinical improvement', 'mycological eradication', 'percentages of patients with mycological eradication, clinical cure and mycological eradication (overall success), clinical improvement (VSS≤1) at test-of-cure visit, and complete resolution of symptoms at follow-up visit (day 25±4', 'overall success', 'rates of clinical cure', 'efficacy and safety', 'Efficacy and safety', 'Symptom resolution', 'percentage of patients with a clinical cure (VSS=0']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0852329', 'cui_str': 'Vulvovaginal signs and symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.506528,"Secondary endpoints included percentages of patients with mycological eradication, clinical cure and mycological eradication (overall success), clinical improvement (VSS≤1) at test-of-cure visit, and complete resolution of symptoms at follow-up visit (day 25±4).
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sobel', 'Affiliation': 'Department of Obstetrics and Gynecology, Jefferson Vulvovaginal Health Center, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nyirjesy', 'Affiliation': 'Department of Obstetrics and Gynecology, Jefferson Vulvovaginal Health Center, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Ghannoum', 'Affiliation': 'Department of Dermatology, Center for Medical Mycology, Case Western Reserve University and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Delchev', 'Affiliation': 'Department of Gynaecology, MHAT Dr. Bratan Shukerov AD, Smolyan, Bulgaria.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Azie', 'Affiliation': 'Departments of Clinical Development and Medical Affairs, SCYNEXIS, Inc., Jersey City, NJ, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Angulo', 'Affiliation': 'Department of Clinical Research, SCYNEXIS, Inc., Jersey City, NJ, USA.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Harriott', 'Affiliation': 'Department of Medical Affairs, SCYNEXIS, Inc., Jersey City, NJ, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Borroto-Esoda', 'Affiliation': 'KBE Consulting, Raleigh, NC, USA.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Sobel', 'Affiliation': 'Infectious Diseases, Department of Internal Medicine, Wayne State University, Detroit, MI, USA.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16972']
1988,34686149,Application of a protective sleeve is associated with decreased occupational anxiety during endotracheal intubation: a randomized controlled trial.,"BACKGROUND


The high risk of cross-infection during tracheal intubation has caused excessive occupational anxiety for anaesthesiologists amid the novel coronavirus disease 2019 (COVID-19) pandemic. Currently, there is no effective way to attenuate their anxiety in clinical practice. We found that anaesthesiologist with better protective equipment might experience decreased levels of anxiety during intubation.
METHODS


In this study, 60 patients who underwent intubation and extubation in the operating room were enrolled, and then randomized 1:1 to either wear protective sleeves (protective sleeve group) or not (control group). Visual analogue scale (VAS) was used to measure the anxiety level of anaesthesiologists during intubation. The respiratory droplets of patients on the sleeve, and the anaesthesiologists' perception including the patient's oral malodour, exertion, satisfaction degree, waist discomfort and shoulder discomfort were recorded. The patients' anxiety, oppressed feelings and hypoxia and postoperative complications were all measured and recorded.
RESULTS


Compared with the control group, the anaesthesiologists in protective sleeve group achieved lower anxiety scores and better satisfaction degrees during the process of intubation and extubation (all P < 0.05). Respiratory droplets were observed only on the inner side, but not the external side, of the protective sleeves (P < 0.001). The incidence of the anaesthesiologists' perception of patients' oral malodour was significantly lower in the protective sleeve group (P = 0.02) and no patients developed hypoxemia or intubation-related complications in the protective sleeve group.
CONCLUSION


Using protective devices for intubation might eliminate droplet transmission from patients to anaesthesiologists, while also decreasing their anxiety in a controlled operating room environment.
TRIAL REGISTRATION


Chinese Clinical Trial. no. ChiCTR2000030705 . Registry at www.chictr.org.cn on 10/03/2020.",2021,"Compared with the control group, the anaesthesiologists in protective sleeve group achieved lower anxiety scores and better satisfaction degrees during the process of intubation and extubation (all P < 0.05).","['60 patients who underwent intubation and extubation in the operating room', 'endotracheal intubation']","['protective sleeve', 'wear protective sleeves (protective sleeve group) or not (control group']","['Respiratory droplets', 'anxiety scores', ""patient's oral malodour, exertion, satisfaction degree, waist discomfort and shoulder discomfort"", ""patients' anxiety, oppressed feelings and hypoxia and postoperative complications"", 'hypoxemia or intubation-related complications', 'anxiety level of anaesthesiologists', 'Visual analogue scale (VAS', 'occupational anxiety', ""incidence of the anaesthesiologists' perception of patients' oral malodour""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1096593', 'cui_str': 'Shoulder discomfort'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",60.0,0.0526254,"Compared with the control group, the anaesthesiologists in protective sleeve group achieved lower anxiety scores and better satisfaction degrees during the process of intubation and extubation (all P < 0.05).","[{'ForeName': 'Chaojin', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Anaesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Shen', 'Affiliation': ""Department of Anaesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, People's Republic of China.""}, {'ForeName': 'Liubing', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Anaesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, People's Republic of China.""}, {'ForeName': 'Tongsen', 'Initials': 'T', 'LastName': 'Luo', 'Affiliation': ""Department of Anaesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, People's Republic of China.""}, {'ForeName': 'Tianyou', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': ""Department of Anaesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, People's Republic of China.""}, {'ForeName': 'Dezhao', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Department of Anaesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Cell-gene Therapy Translational Medicine Research Center, The Third Affiliated Hospital, Sun Yat-sen University, No.600 Tianhe Road, Guangzhou, People's Republic of China. zhangq27@mail.sysu.edu.cn.""}, {'ForeName': 'Ziqing', 'Initials': 'Z', 'LastName': 'Hei', 'Affiliation': ""Department of Anaesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, People's Republic of China. heiziqing@sina.com.""}]",BMC anesthesiology,['10.1186/s12871-021-01467-7']
1989,34686555,"Total hip arthroplasty versus progressive resistance training in patients with severe hip osteoarthritis: protocol for a multicentre, parallel-group, randomised controlled superiority trial.","INTRODUCTION


Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain, and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appears to improve multiple outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary aim of this trial is to investigate whether THA followed by standard care is superior to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT for improving hip pain and function in patients with severe hip OA.
METHODS AND ANALYSIS


This is a protocol for a multicentre, parallel-group, assessor-blinded, randomised controlled superiority trial conducted at four hospitals across three healthcare regions in Denmark. 120 patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA followed by standard care, or 12 weeks of PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score, from baseline to 6 months after initiating the treatment. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40 m fast-paced walk test, 30 s chair stand test and occurrence of serious adverse events. Patients declining participation in the trial will be invited into a prospective observational cohort study.
ETHICS AND DISSEMINATION


The trial has been approved by The Regional Committees on Health Research Ethics for Southern Denmark (Project-ID: S-20180158). All results will be presented in peer-reviewed scientific journals and international conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (NCT04070027).",2021,"Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40 m fast-paced walk test, 30 s chair stand test and occurrence of serious adverse events.","['patients with hip OA', 'patients with severe hip OA', 'patients with severe hip osteoarthritis', 'four hospitals across three healthcare regions in Denmark', '120 patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon']","['Total hip arthroplasty versus progressive resistance training', 'THA', 'Progressive resistance training (PRT']","['Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40 m fast-paced walk test, 30 s chair stand test and occurrence of serious adverse events', 'change in patient-reported hip pain and function, measured using the Oxford Hip Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C2960303', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1998079', 'cui_str': 'Oxford hip score'}]",120.0,0.260169,"Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40 m fast-paced walk test, 30 s chair stand test and occurrence of serious adverse events.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Frydendal', 'Affiliation': 'Department of Physio- and Occupational Therapy, Lillebaelt Hospital - University Hospital of Southern Denmark, Vejle, Denmark thomas.frydendal@rsyd.dk.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Mechlenburg', 'Affiliation': 'Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lone Ramer', 'Initials': 'LR', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Overgaard', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kim Gordon', 'Initials': 'KG', 'LastName': 'Ingwersen', 'Affiliation': 'Department of Physio- and Occupational Therapy, Lillebaelt Hospital - University Hospital of Southern Denmark, Vejle, Denmark.'}]",BMJ open,['10.1136/bmjopen-2021-051392']
1990,34688102,"An online, single-session intervention for adolescent self-injurious thoughts and behaviors: Results from a randomized trial.","BACKGROUND


Across 50 years of research, existing interventions for self-injurious thoughts and behaviors (SITBs) in adolescents have remained largely ineffective and inaccessible. Single-session interventions, interventions designed to last one session, may be a low-cost and timely resource for adolescents engaging in SITBs who may not otherwise receive treatment.
METHOD


565 adolescents (M age  = 14.95 years) endorsing recent engagement in non-suicidal self-injury (NSSI) were randomized to receive a 30-min, web-based, single-session intervention-""Project SAVE""-or an active, attention-matched control program. Proximal outcomes were measured at baseline and immediately post-intervention. Long-term outcomes were measured at baseline and 3-month follow-up.
RESULTS


Adolescents rated Project SAVE as acceptable; 80% of participants randomized to SAVE completed the intervention. Between-group effects were non-significant for pre-registered outcomes: post-intervention likelihood of future NSSI; 3-month frequencies of NSSI and suicidal ideation at follow-up. Relative to control-group participants, SAVE participants reported short-term improvements in two exploratory outcomes: self-hatred (d = -.35, p<.001) and desire to stop future NSSI (d = .25, p = .003).
CONCLUSIONS


Project SAVE is an acceptable resource for adolescents engaging in SITBs-with short-term effects on clinically-relevant outcomes. Future research may evaluate SAVE as an easy-to-access, short-term coping resource for youth engaging in SITBs. CLINICAL TRIALS.
GOV IDENTIFIER


NCT04498143.",2021,"Relative to control-group participants, SAVE participants reported short-term improvements in two exploratory outcomes: self-hatred (d = -.35, p<.001) and desire to stop future NSSI","['565 adolescents (M age \xa0=\xa014.95 years) endorsing recent engagement in non-suicidal self-injury (NSSI', 'adolescents engaging in SITBs who may not otherwise receive treatment']","['single-session intervention-""Project SAVE""-or an active, attention-matched control program']","['desire to stop future NSSI', 'Proximal outcomes', 'NSSI and suicidal ideation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",565.0,0.184052,"Relative to control-group participants, SAVE participants reported short-term improvements in two exploratory outcomes: self-hatred (d = -.35, p<.001) and desire to stop future NSSI","[{'ForeName': 'Mallory L', 'Initials': 'ML', 'LastName': 'Dobias', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, 11794-2500, USA. Electronic address: mallory.dobias@stonybrook.edu.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Schleider', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, 11794-2500, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jans', 'Affiliation': 'Department of Psychology, University of Denver, Denver, CO, 80208, USA.'}, {'ForeName': 'Kathryn R', 'Initials': 'KR', 'LastName': 'Fox', 'Affiliation': 'Department of Psychology, University of Denver, Denver, CO, 80208, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103983']
1991,34688064,Effects of sex and walking speed on the dynamic stiffness of lower limb joints.,"Fast walking may require a non-uniform change of dynamic stiffness among lower limb joints to deal with this daily task's demands. The change of dynamic joint stiffness may be distinct between females and males. This study aimed to test for differences in dynamic stiffness among lower limb joints in response to increased walking speed in males and females. Thirty-five participants walked in two randomized conditions: self-selected speed and fast speed (25% greater than the self-selected speed). Dynamic stiffnesses of the ankle, knee, and hip were calculated as the linear slope of the moment-angle curve's regression line during their major power absorption phase of the walking cycle. The comparison between conditions showed that the knee (p < 0.001) and hip (p = 0.031) increased their stiffness at the fast compared to self-selected speed. Ankle stiffness was not different between conditions (p = 0.818). The comparison among joints across speeds showed that the knee had a greater increase than the ankle (p = 0.001) and hip (p < 0.001), with no difference between ankle and hip (p = 0.081). The sex of the participant influenced only the ankle stiffness, in which males had greater stiffness than females (p = 0.008). These findings demonstrated that the lower limb joints changed their dynamic stiffness differently, and only the ankle stiffness was influenced by sex. The non-uniform adjustments of stiffness may provide the necessary stability and allow the individual to deal with greater demand for walking fast.",2021,"The comparison among joints across speeds showed that the knee had a greater increase than the ankle (p = 0.001) and hip (p < 0.001), with no difference between ankle and hip (p = 0.081).","['lower limb joints', 'Thirty-five participants walked in two randomized conditions: self-selected speed and fast speed (25% greater than the self-selected speed', 'males and females']",['Fast walking'],"['ankle stiffness', 'dynamic joint stiffness', 'Ankle stiffness', 'Dynamic stiffnesses of the ankle, knee, and hip']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0427032', 'cui_str': 'Ankle stiff'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]",35.0,0.0365153,"The comparison among joints across speeds showed that the knee had a greater increase than the ankle (p = 0.001) and hip (p < 0.001), with no difference between ankle and hip (p = 0.081).","[{'ForeName': 'Thiago R T', 'Initials': 'TRT', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Therapy, School of Physical Education, Physical Therapy and Occupational Therapy, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: trtsantos@ufmg.br.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Araújo', 'Affiliation': 'Department of Physical Therapy, School of Physical Education, Physical Therapy and Occupational Therapy, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Khuu', 'Affiliation': 'Department of Physical Therapy and Athletic Training, College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, USA.'}, {'ForeName': 'Sangjun', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA, USA; The Wyss Institute for Biologically Inspired Engineering, Cambridge, MA, USA.'}, {'ForeName': 'Cara L', 'Initials': 'CL', 'LastName': 'Lewis', 'Affiliation': 'Department of Physical Therapy and Athletic Training, College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, USA.'}, {'ForeName': 'Thales R', 'Initials': 'TR', 'LastName': 'Souza', 'Affiliation': 'Department of Physical Therapy, School of Physical Education, Physical Therapy and Occupational Therapy, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Holt', 'Affiliation': 'Department of Physical Therapy and Athletic Training, College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, USA; The Wyss Institute for Biologically Inspired Engineering, Cambridge, MA, USA.'}, {'ForeName': 'Sergio T', 'Initials': 'ST', 'LastName': 'Fonseca', 'Affiliation': 'Department of Physical Therapy, School of Physical Education, Physical Therapy and Occupational Therapy, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: sfonseca@ufmg.br.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2021.110803']
1992,34687986,Adherence to levetiracetam for management of epilepsy: Assessment with electronic monitors.,"INTRODUCTION


Anti-seizure medications are used to manage epilepsy and require long-term adherence to maintain therapeutic drug levels. We assessed adherence to levetiracetam and the use of a digital intervention to improve adherence in patients with epilepsy.
METHODS


30 participants with epilepsy were randomized 1:1 either to a digital email adherence intervention or control group. All patients were provided levetiracetam equipped with electronic monitoring caps to assess patient adherence to medication. Patients were followed for 6 months, with return visits at 1 month, 3 months, and 6 months.
RESULTS


Subjects randomized to the control arm (n = 15) took 66% of the prescribed doses compared to the intervention group, who took 65% of prescribed doses (n = 15). Nine participants did not complete the study. Of the twenty-one participants that completed the study, the overall rate of adherence was 72% of prescribed doses taken. Two subjects in the control group and three subjects in the intervention group were adherent every month of the study-taking at least 80% of prescribed doses. Those randomized to the control group took the correct number of doses 44% of days in the study, and those in the intervention group took the correct number of doses 37% of days.
DISCUSSION


Poor adherence to levetiracetam is common. An internet-based email survey intervention did not improve adherence to levetiracetam in epilepsy patients. Further advances in adherence are needed to help patients receive the maximum benefit of their medical treatments.",2021,"Of the twenty-one participants that completed the study, the overall rate of adherence was 72% of prescribed doses taken.","['epilepsy patients', '30 participants with epilepsy', 'patients with epilepsy']","['levetiracetam', 'digital email adherence intervention or control group', 'levetiracetam equipped with electronic monitoring caps', 'digital intervention']",['overall rate of adherence'],"[{'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",30.0,0.0364187,"Of the twenty-one participants that completed the study, the overall rate of adherence was 72% of prescribed doses taken.","[{'ForeName': 'Sree S', 'Initials': 'SS', 'LastName': 'Kolli', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem 27157-1071, NC, United States.'}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Snyder', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem 27157-1071, NC, United States. Electronic address: snsnyder@wakehealth.edu.'}, {'ForeName': 'Leah A', 'Initials': 'LA', 'LastName': 'Cardwell', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem 27157-1071, NC, United States.'}, {'ForeName': 'Abigail E', 'Initials': 'AE', 'LastName': 'Cline', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem 27157-1071, NC, United States.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Unrue', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem 27157-1071, NC, United States.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem 27157-1071, NC, United States; Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Social Sciences & Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Dermatology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Cormac A', 'Initials': 'CA', 'LastName': 'O Donovan', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}]",Seizure,['10.1016/j.seizure.2021.10.008']
1993,34687944,Acceptance and Commitment Training for Veterans with polytrauma: A randomized controlled trial protocol.,"BACKGROUND


Mild traumatic brain injury (mTBI) is a signature wound of Veterans of operations in Iraq and Afghanistan (i.e., OIF/OEF/OND). Most Veterans with mTBI also experience stress-based psychopathology (e.g., depression, posttraumatic stress disorder) and chronic pain. This combination - referred to as polytrauma - results in detrimental long-term effects on social, occupational, and community reintegration. This study will compare the efficacy of a one-day Acceptance and Commitment Training plus Education, Resources, and Support (ACT+ERS) workshop to a one-day active control group (ERS) on symptoms of distress and social, occupational, and community reintegration. We will also examine mediators and moderators of treatment response.
METHODS


This is an ongoing randomized clinical trial. 212 OIF/OEF/OND Veterans with polytrauma are being recruited. Veterans are randomly assigned to a one-day ACT+ERS or a one-day ERS workshop with two individualized booster sessions approximately two- and four-weeks post-workshop. Veterans complete assessments prior to the workshop and again at six weeks, three months, and six months post-workshop. Of note, workshops were converted to a virtual format due to the COVID-19 pandemic.
RESULTS


The primary outcomes are symptoms of distress and reintegration; secondary outcomes are post-traumatic stress disorder symptoms and pain interference. Secondary analyses will assess whether changes in avoidance at three months mediate changes in distress and reintegration at six months.
CONCLUSION


Facilitating the psychological adjustment and reintegration of Veterans with polytrauma is critical. The results of this study will provide important information about the impact of a brief intervention for Veterans with these concerns.",2021,"Secondary analyses will assess whether changes in avoidance at three months mediate changes in distress and reintegration at six months.
","['212 OIF/OEF/OND Veterans with polytrauma are being recruited', 'Veterans with these concerns', 'Veterans with polytrauma']",['Acceptance and Commitment Training'],"['symptoms of distress and social, occupational, and community reintegration', 'distress and reintegration', 'symptoms of distress and reintegration; secondary outcomes are post-traumatic stress disorder symptoms and pain interference']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",212.0,0.0898993,"Secondary analyses will assess whether changes in avoidance at three months mediate changes in distress and reintegration at six months.
","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Uzdavines', 'Affiliation': 'South Central Mental Illness Research, Education, and Clinical Center, Michael E. DeBakey VA Medical Center, Houston, TX, United States of America; Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Raquel D', 'Initials': 'RD', 'LastName': 'Gonzalez', 'Affiliation': 'South Central Mental Illness Research, Education, and Clinical Center, Michael E. DeBakey VA Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Price', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America; Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Dakota', 'Initials': 'D', 'LastName': 'Broadway', 'Affiliation': 'South Central Mental Illness Research, Education, and Clinical Center, Michael E. DeBakey VA Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Smith', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Merlyn', 'Initials': 'M', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America; Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Woods', 'Affiliation': 'South Central Mental Illness Research, Education, and Clinical Center, Michael E. DeBakey VA Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'M Bridget', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'College of Public Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Jorge', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America; Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Dindo', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America; Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America. Electronic address: lilian.dindo@bcm.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106601']
1994,34678678,A phase II randomised study of preoperative trastuzumab alone or combined with everolimus in patients with early HER2-positive breast cancer and predictive biomarkers (RADHER trial).,"INTRODUCTION


Resistance to trastuzumab in breast cancer is an ongoing challenge. Clinical and biological effects of co-targeting HER2 and mammalian target of rapamycin (mTOR) in patients with HER2-positive early operable breast cancer via the addition of everolimus to preoperative trastuzumab were evaluated in a phase II randomised study.
METHODS


Patients were randomised 1:1 to receive trastuzumab (4 mg/kg initial dose then 2 mg/kg weekly for 5 weeks) alone or combined with everolimus (10 mg/day for 6 weeks) and then underwent surgery. Tumours were assessed by clinical examination and echography at the baseline and on treatment. The primary end-point was the clinical response rate at 6 weeks. Pathological response and safety were also evaluated. Baseline and surgery tumour samples were assessed by immunohistochemistry and multiplex immunoanalysis for predictive downstream effectors of the PI3K/AKT/mTOR and MAP kinase (MAPK) pathways.
RESULTS


Eighty-two patients were enrolled, 41 per arm. The clinical response rates were 34.1% and 43.9% with trastuzumab alone and combined with everolimus, respectively. Pathological response rates were 43.6% and 47.5%, respectively. Addition of everolimus increased toxicity, notably mucositis (82.5% versus 5.0%) and rash (57.5% versus 10.0%), but grade III/IV events were rare. No correlation between response to treatments and baseline candidate biomarkers was identified, except for PIK3CA mutations which were found to predict trastuzumab resistance. Significant changes were seen in several MAPK pathway effectors after combination therapy.
CONCLUSIONS


The addition of everolimus did not improve the efficacy, but induced MAPK signalling. Combination therapy to overcome pathway cross-talk should be considered to maximise the effectiveness of trastuzumab in this setting. ClinicalTrial.gov Identifier NCT00674414.",2021,"Addition of everolimus increased toxicity, notably mucositis (82.5% versus 5.0%) and rash (57.5% versus 10.0%), but grade III/IV events were rare.","['patients with early HER2-positive breast cancer and predictive biomarkers (RADHER trial', 'patients with HER2-positive early operable breast cancer', 'Eighty-two patients were enrolled, 41 per arm', 'Patients']","['preoperative trastuzumab alone or combined with everolimus', 'co-targeting HER2 and mammalian target of rapamycin (mTOR', 'trastuzumab (4\xa0mg/kg initial dose then 2\xa0mg/kg weekly for 5 weeks) alone or combined with everolimus', 'everolimus']","['clinical response rates', 'several MAPK pathway effectors', 'toxicity, notably mucositis', 'Pathological response rates', 'Pathological response and safety', 'clinical response rate', 'rash']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0293060', 'cui_str': 'FKBP12-Rapamycin Associated Protein'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",82.0,0.0973555,"Addition of everolimus increased toxicity, notably mucositis (82.5% versus 5.0%) and rash (57.5% versus 10.0%), but grade III/IV events were rare.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Department of Medical Oncology/ Cancer Research Center UMR-INSERM U892/CNRS 6299/ Bioinformatics Unit, Institut de Cancérologie de L'Ouest, Nantes, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, INSERM U1052, Lyon, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Treilleux', 'Affiliation': 'Department of Pathology and Biopathology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pistilli', 'Affiliation': 'Department of Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Salleron', 'Affiliation': 'Methodology and Biostatistics Unit, Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Seegers', 'Affiliation': ""Oncology Data Factory and Analytics, Institut de Cancérologie de L'Ouest, Nantes, France.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Arnedos', 'Affiliation': 'Department of Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Loussouarn', 'Affiliation': 'Department of Pathology, Hôpital G&R Laënnec, St. Herblain, France.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Genomic Platform-Cancer Research Center of Lyon, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Vanlemmens', 'Affiliation': 'Department of Medical Oncology, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jimenez', 'Affiliation': 'R&D Unicancer, UNICANCER, Paris, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rios', 'Affiliation': 'Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Leroux', 'Affiliation': 'Department of Biopathology, Institut de Cancérologie de Lorraine, Université de Lorraine, CNRS UMR 7039, CRAN, Vandoeuvre-Les-Nancy, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Paintaud', 'Affiliation': 'François Rabelais University, CNRS, UMR 7292, Genetics, Immunotherapy, Chemistry and Cancer, Tours, France.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Rezai', 'Affiliation': 'Radio-Pharmacology Department, Institut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Department of Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Maëva', 'Initials': 'M', 'LastName': 'Lion', 'Affiliation': 'Department of Biopathology, Institut de Cancérologie de Lorraine, Université de Lorraine, CNRS UMR 7039, CRAN, Vandoeuvre-Les-Nancy, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Merlin', 'Affiliation': 'Department of Biopathology, Institut de Cancérologie de Lorraine, Université de Lorraine, CNRS UMR 7039, CRAN, Vandoeuvre-Les-Nancy, France. Electronic address: jl.merlin@nancy.unicancer.fr.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.09.017']
1995,34678337,In vitro evaluation of marginal adaptation in medium- and large size direct class II restorations using a bulk-fill or layering technique.,"OBJECTIVES


to test if cavity dimensions and restorative protocol have potential to influence in-vitro adaptation of class II restoration after simulated thermo-occlusal stressing.
METHODS


A total of 32 prepared teeth were randomly assigned to one of the 4 experimental groups depending on cavity size, composite system and filling technique; group 1: small cavity and multi-layered conventional restorative composite (Tetric Evo-ceram: TEC), group 2: small cavity and flowable bulk-filled composite (SDRFlow: SDR) + one single occlusal layer of conventional restorative composite (TEC), group 3: large cavity and multilayered conventional restorative composite (TEC) and group 4: large cavity and bulk-filled flowable composite (SDR) + one single occlusal layer conventional restorative composite (TEC). All specimens were submitted to 500'000 cycles of thermomechanical loading (50 N, 5 to 55 °C). The proximal tooth-restoration interface was analyzed quantitatively by SEM, prior and after thermomechanical loading.
RESULTS


Before loading, continuous enamel adaptation varied from 61.49% (Gr 1) to 68.39% (Gr 4) proximally and from 50.93% (Gr2) to 68.65% (Gr1) cervically, with no statistical difference among groups for both segments. After thermomechanical loading, continuous enamel adaptation varied from 36.6% (Gr2) to 46.6% (Gr1) proximally, without significant difference, and from 20.2% (Gr4) to 51.3% (Gr1) cervically; statistical differences in cervical enamel adaptation were found in-between groups 1 and 2 (p = 0.0479), 1 and 4 (P = 0.0116), 2 and 3 (p = 0.0028) and 3 and 4 (p = 0.001). Before loading, dentin continuous adaptation varied from 55.32% (Gr3) to 81.82% (Gr4) with statistical difference in-between those groups (p = 0.045); after loading, dentin continuous adaptation varied from 31.56% (gr2) to 51% (Gr4) with a statistical difference between those 2 groups (p = 0.019). The drop in adaptations values after loading was significant in all groups and segments.
CONCLUSIONS


The impact of the restorative technique and cavity size on marginal adaptation appeared essentially after simulated fatigue for enamel adaptation. Cervical enamel and dentin continuous adaption of small and large bulk-filled restorations dropped significantly while the change was lower in layered restorations made of conventional restorative composite.
CLINICAL SIGNIFICANCE


Restorations made with bulk-filled flowable composite behaved differently from layered ones using conventional resin composite, according to cavity size and loading.",2021,"Cervical enamel and dentin continuous adaption of small and large bulk-filled restorations dropped significantly while the change was lower in layered restorations made of conventional restorative composite.
",['A total of 32 prepared teeth'],"['cavity size, composite system and filling technique; group 1: small cavity and multi-layered conventional restorative composite (Tetric Evo-ceram: TEC), group 2: small cavity and flowable bulk-filled composite (SDRFlow: SDR)\u202f+\u202fone single occlusal layer of conventional restorative composite (TEC), group 3: large cavity and multilayered conventional restorative composite (TEC) and group 4: large cavity and bulk-filled flowable composite (SDR)\u202f+\u202fone single occlusal layer conventional restorative composite (TEC', 'restorative technique and cavity size']","['Cervical enamel and dentin continuous adaption of small and large bulk-filled restorations', 'dentin continuous adaptation', 'continuous enamel adaptation', 'cervical enamel adaptation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0292041', 'cui_str': 'Tetric'}, {'cui': 'C0229951', 'cui_str': 'Thymic epithelial cell'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0673997', 'cui_str': 'flowable hybrid composite'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",32.0,0.103238,"Cervical enamel and dentin continuous adaption of small and large bulk-filled restorations dropped significantly while the change was lower in layered restorations made of conventional restorative composite.
","[{'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Dietschi', 'Affiliation': 'Department of Cariology, Endodontology & Pediatric Dentistry, School of Dentistry, University of Geneva, Geneva, Switzerland. Electronic address: didier.dietschi@unige.ch.'}, {'ForeName': 'Filipo Del', 'Initials': 'FD', 'LastName': 'Curto', 'Affiliation': 'Department of Cariology, Endodontology & Pediatric Dentistry, School of Dentistry, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Di Bella', 'Affiliation': 'Department of Political Sciences, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Krejci', 'Affiliation': 'Department of Cariology, Endodontology & Pediatric Dentistry, School of Dentistry, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ardu', 'Affiliation': 'Department of Cariology, Endodontology & Pediatric Dentistry, School of Dentistry, University of Geneva, Geneva, Switzerland.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103828']
1996,34666678,Optimising personal continuity for older patients in general practice: a study protocol for a cluster randomised stepped wedge pragmatic trial.,"BACKGROUND


Continuity of care, in particular personal continuity, is a core principle of general practice and is associated with many benefits such as a better patient-provider relationship and lower mortality. However, personal continuity is under pressure due to changes in society and healthcare. This affects older patients more than younger patients. As the number of older patients will double the coming decades, an intervention to optimise personal continuity for this group is highly warranted.
METHODS


Following the UK Medical Research Council framework for complex Interventions, we will develop and evaluate an intervention to optimise personal continuity for older patients in general practice. In phase 0, we will perform a literature study to provide the theoretical basis for the intervention. In phase I we will define the components of the intervention by performing surveys and focus groups among patients, general practitioners, practice assistants and practice nurses, concluded by a Delphi study among members of our group. In phase II, we will test and finalise the intervention with input from a pilot study in two general practices. In phase III, we will perform a stepped wedge cluster randomised pragmatic trial. The primary outcome measure is continuity of care from the patients' perspective, measured by the Nijmegen Continuity Questionnaire. Secondary outcome measures are level of implementation, barriers and facilitators for implementation, acceptability and feasibility of the intervention. In phase IV, we will establish the conditions for large-scale implementation.
DISCUSSION


This is the first study to investigate an intervention for improving personal continuity for older patients in general practice. If proven effective, our intervention will enable General practitioners to improve the quality of care for their increasing population of older patients. The pragmatic design of the study will enable evaluation in real-life conditions, facilitating future implementation.
TRIAL REGISTRATION NUMBER


Netherlands Trial Register, trial NL8132 . Registered 2 November 2019.",2021,"If proven effective, our intervention will enable General practitioners to improve the quality of care for their increasing population of older patients.","['patients, general practitioners, practice assistants and practice nurses, concluded by a Delphi study among members of our group', 'older patients in general practice', 'older patients more than younger patients']",[],"['level of implementation, barriers and facilitators for implementation, acceptability and feasibility of the intervention', ""continuity of care from the patients' perspective, measured by the Nijmegen Continuity Questionnaire""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0086109', 'cui_str': 'Delphi Studies'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",2.0,0.0845413,"If proven effective, our intervention will enable General practitioners to improve the quality of care for their increasing population of older patients.","[{'ForeName': 'Lex J J', 'Initials': 'LJJ', 'LastName': 'Groot', 'Affiliation': 'Department of General Practice, Amsterdam University Medical Centre, location VU University Medical Centre, van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands. l.groot@amsterdamumc.nl.'}, {'ForeName': 'Henk J', 'Initials': 'HJ', 'LastName': 'Schers', 'Affiliation': 'Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, Geert Grooteplein 21, 6525, EZ, Nijmegen, The Netherlands.'}, {'ForeName': 'Jako S', 'Initials': 'JS', 'LastName': 'Burgers', 'Affiliation': 'MUMC+/ Maastricht University, Department of General Practice, Care and Public Health Research Institute (CAPHRI), Universiteitssingel 40, 6229, ER, Maastricht, the Netherlands.'}, {'ForeName': 'Francois G', 'Initials': 'FG', 'LastName': 'Schellevis', 'Affiliation': 'Department of General Practice, Amsterdam University Medical Centre, location VU University Medical Centre, van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Smalbrugge', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Centre, location VU University Medical Centre, De Boelelaan 1109, 1081, HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Annemarie A', 'Initials': 'AA', 'LastName': 'Uijen', 'Affiliation': 'Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, Geert Grooteplein 21, 6525, EZ, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Data Science, Vrije Universiteit Amsterdam, De Boelelaan 1089a, 1081, HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Department of General Practice, Amsterdam University Medical Centre, location VU University Medical Centre, van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Otto R', 'Initials': 'OR', 'LastName': 'Maarsingh', 'Affiliation': 'Department of General Practice, Amsterdam University Medical Centre, location VU University Medical Centre, van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}]",BMC family practice,['10.1186/s12875-021-01511-y']
1997,34656813,"Smiling won't necessarily make you feel better: Response-focused emotion regulation strategies have little impact on cognitive, behavioural, physiological, and subjective outcomes.","BACKGROUND AND OBJECTIVES


Response-focused emotion regulation (RF-ER) strategies may alter people's evoked emotions, influencing intrapersonal outcomes. Researchers have found that participants engaging in expressive suppression (ES; a RF-ER strategy) experience increased sympathetic nervous system arousal, affect, and lowered memory accuracy. It is unclear, however, whether all RF-ER strategies exert maladaptive effects. Expressive dissonance (ED; displaying an expression opposite from how one feels) is a RF-ER strategy, and likely considered ""maladaptive"". As outlined by the facial feedback hypothesis, however, smiling may increase positive emotion, suggesting it may be an adaptive strategy. We compared the effects of ED and ES to a control condition on psychophysiology, memory, and affect, to assess whether ED is an adaptive RF-ER strategy, relative to ES, in response to negative stimuli. We recruited women only to account for known gender-based differences in emotion regulation.
METHODS


We randomly assigned 144 women-identifying participants to engage in ED, ES, or to naturally observe, while viewing negative and arousing images. We recorded electrodermal activity and self-reported affect throughout and participants completed memory tasks after the picture task.
RESULTS


We ran a series of repeated measures and one-way ANOVAs and found no differences between groups across outcomes.
LIMITATIONS


The generalizability of our findings may be limited to young, undergraduate women.
CONCLUSION


Engaging in ES or ED may not differentially impact outcomes among young, undergraduate women, shedding doubt on a conclusion in past literature that specific strategies are categorically adaptive or maladaptive. Future research exploring RF-ER strategies among diverse populations is warranted.",2021,"Researchers have found that participants engaging in expressive suppression (ES; a RF-ER strategy) experience increased sympathetic nervous system arousal, affect, and lowered memory accuracy.","['young, undergraduate women', '144 women-identifying participants to engage in ED, ES, or to naturally observe, while viewing negative and arousing images']",['RF-ER'],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",[],144.0,0.064148,"Researchers have found that participants engaging in expressive suppression (ES; a RF-ER strategy) experience increased sympathetic nervous system arousal, affect, and lowered memory accuracy.","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bahl', 'Affiliation': 'School of Psychology, University of Ottawa, Canada. Electronic address: nbahl066@uottawa.ca.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Ouimet', 'Affiliation': 'School of Psychology, University of Ottawa, Canada. Electronic address: allison.ouimet@uottawa.ca.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2021.101695']
1998,34666214,Immune infiltrates in patients with localised high-risk soft tissue sarcoma treated with neoadjuvant chemotherapy without or with regional hyperthermia: A translational research program of the EORTC 62961-ESHO 95 randomised clinical trial.,"BACKGROUND


The EORTC 62961-ESHO 95 randomised trial showed improved long-term survival of patients with high-risk soft-tissue sarcoma by adding regional hyperthermia to neoadjuvant chemotherapy. We hypothesised that immune infiltrate of patients treated with neoadjuvant therapy associate with clinical outcome.
METHODS


Tumour infiltrating lymphocytes (TILs) and CD8, FOXP3, PD-1, and PD-L1 were evaluated in sequential biopsies of patients after four cycles of therapy.
RESULTS


From a subgroup of 109 patients who had been randomised between July 1997 and November 2006 to neoadjuvant chemotherapy (53 patients) or neoadjuvant chemotherapy with regional hyperthermia (56 patients), 137 biopsies were obtained. TILs increased in paired second biopsies independent of treatment allocation (p < 0.001). FOXP3 regulatory T cells decreased (p = 0.002), and PD-L1 expression of tumours became undetectable. In the multivariate analysis, post-treatment high TILs correlated to LPFS (HR: 0.34; 95% CI 0.15-0.75; p = 0.008) and DFS (HR: 0.38; 95% CI 0.17-0.82; p = 0.015). In comparing post-treatment immune infiltrate between treatment arms, tumour response was associated with neoadjuvant chemotherapy with regional hyperthermia (p = 0.013) and high TILs (p = 0.064). High CD8 cell infiltration was associated with improved LPFS (HR: 0.27; 95% CI 0.09-0.79; Log-rank p = 0.011) and DFS (HR: 0.25; 95% CI 0.09-0.73; Log-rank p = 0.006). Improved survival at 10 years was associated with immune infiltrate after neoadjuvant chemotherapy with regional hyperthermia.
CONCLUSION


Preoperative therapy re-programs a non-inflamed tumour at baseline into an inflamed tumour. The post-treatment immune infiltrate became predictive for clinical outcomes. The combination with regional hyperthermia primes the tumour microenvironment, enabling enhanced anti-tumour immune activity in high-risk soft tissue sarcomas.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT00003052.",2021,"regulatory T cells decreased (p = 0.002), and PD-L1 expression of tumours became undetectable.","['patients with high-risk soft-tissue sarcoma by adding regional hyperthermia to neoadjuvant chemotherapy', '109 patients who had been randomised between July 1997 and November 2006 to neoadjuvant chemotherapy (53 patients) or', 'patients treated with neoadjuvant therapy associate with clinical outcome', 'patients with localised high-risk soft tissue sarcoma treated with']","['FOXP3', 'neoadjuvant chemotherapy with regional hyperthermia', 'neoadjuvant chemotherapy without or with regional hyperthermia']","['Improved survival', 'High CD8 cell infiltration', 'regulatory T cells', 'Tumour infiltrating lymphocytes (TILs) and CD8, FOXP3, PD-1, and PD-L1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}]",137.0,0.158554,"regulatory T cells decreased (p = 0.002), and PD-L1 expression of tumours became undetectable.","[{'ForeName': 'Rolf D', 'Initials': 'RD', 'LastName': 'Issels', 'Affiliation': 'Department of Medicine III, University Hospital, LMU, Marchioninistr.15, Munich, 81377, Germany. Electronic address: Rolf.Issels@med.uni-muenchen.de.'}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Noessner', 'Affiliation': 'Helmholtz Zentrum München, German Research Center for Environmental Health, Germany.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lindner', 'Affiliation': 'Department of Medicine III, University Hospital, LMU, Marchioninistr.15, Munich, 81377, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'Munich Cancer Registry, Institute of Medical Information Processing, Biometry and Epidemiology, LMU, Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Albertsmeier', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, LMU Munich, Munich, Germany.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medicine, Centre Leon Berard, 28 Rue Laennec1, Lyon, 69373, France.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Stutz', 'Affiliation': 'Dept. of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, Bern Freiburgstr.18, Switzerland.'}, {'ForeName': 'Yujun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Institute of Medical Informatics, Biometry and Epidemiology (IBE), LMU Munich, Germany.'}, {'ForeName': 'Veit', 'Initials': 'V', 'LastName': 'Buecklein', 'Affiliation': 'Department of Medicine III, University Hospital, LMU, Marchioninistr.15, Munich, 81377, Germany.'}, {'ForeName': 'Annelore', 'Initials': 'A', 'LastName': 'Altendorf-Hofmann', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, University Hospital Jena, Germany.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Abdel-Rahman', 'Affiliation': 'Department of Medicine III, University Hospital, LMU, Marchioninistr.15, Munich, 81377, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': 'Institute of Medical Informatics, Biometry and Epidemiology (IBE), LMU Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'von Bergwelt-Baildon', 'Affiliation': 'Deutsches Konsortium für Translationale Krebsforschung, Bayrisches Zentrum für Krebsforschung, and Comprehensive Cancer Center LMU, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Knoesel', 'Affiliation': 'Institute of Pathology, LMU, Thalkirchner Str.36, Munich, 80337, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.09.015']
1999,34677136,How Food Marketing on Instagram Shapes Adolescents' Food Preferences: Online Randomized Trial.,"BACKGROUND


Worldwide obesity rates have prompted 16 countries to enact policies to reduce children's exposure to unhealthy food marketing, but few policies address online advertising practices or protect adolescents from being targeted. Given adolescents spend so much time online, it is critical to understand how persuasive Instagram food advertisements (ads) are compared with traditional food ads. To strengthen online food marketing policies, more evidence is needed on whether social media ads are more persuasive than other types of ads in shaping adolescents' preferences.
OBJECTIVE


This study examined whether adolescents could identify food companies' Instagram posts as ads, and the extent to which Instagram versus traditional food ads shape adolescents' preferences.
METHODS


In Part 1, participants aged 13-17 years (N=832) viewed 8 pairs of ads and were asked to identify which ads originated from Instagram. One ad in each pair was selected from traditional sources (eg, print; online banner ad), and the other ad was selected from Instagram, but we removed the Instagram frame-which includes the logo, comments, and ""likes."" In Part 2, participants were randomized to rate food ads that ostensibly originated from (1) Instagram (ie, we photoshopped the Instagram frame onto ads); or (2) traditional sources. Unbeknownst to participants, half of the ads in their condition originated from Instagram and half originated from traditional sources.
RESULTS


In Part 1, adolescents performed worse than chance when asked to identify Instagram ads (P<.001). In Part 2, there were no differences on 4 of 5 outcomes in the ""labeled ad condition."" In the ""unlabeled ad condition,"" however, they preferred Instagram ads to traditional ads on 3 of 5 outcomes (ie, trendiness, P=.001; artistic appeal, P=.001; likeability, P=.001).
CONCLUSIONS


Adolescents incorrectly identified traditional ads as Instagram posts, suggesting the artistic appearance of social media ads may not be perceived as marketing. Further, the mere presence of Instagram features caused adolescents to rate food ads more positively than ads without Instagram features.",2021,"In Part 1, adolescents performed worse than chance when asked to identify Instagram ads (P<.001).",['participants aged 13-17 years (N=832) viewed 8 pairs of ads and were asked to identify which ads originated from Instagram'],"['rate food ads that ostensibly originated from (1) Instagram (ie, we photoshopped the Instagram frame onto ads); or (2) traditional sources']",['labeled ad condition'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0449416', 'cui_str': 'Source'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.207392,"In Part 1, adolescents performed worse than chance when asked to identify Instagram ads (P<.001).","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bragg', 'Affiliation': 'Department of Population Health, New York University Grossman School of Medicine, New York City, NY, United States.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Lutfeali', 'Affiliation': 'Stanford Graduate School of Business, Palo Alto, CA, United States.'}, {'ForeName': 'Tenay', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Department of Population Health, New York University Grossman School of Medicine, New York City, NY, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Osterman', 'Affiliation': 'Department of Population Health, New York University Grossman School of Medicine, New York City, NY, United States.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Dalton', 'Affiliation': 'Department of Pediatrics, Dartmouth Geisel School of Medicine, Hanover, NH, United States.'}]",Journal of medical Internet research,['10.2196/28689']
2000,34664772,Effect of DrOnedarone on atrial fibrosis progression and atrial fibrillation recurrence postablation: Design of the EDORA randomized clinical trial.,"BACKGROUND


Atrial fibrillation (AF) recurrence after catheter ablation is associated with worse outcomes and quality of life. Left atrial (LA) structural remodeling provides the essential substrate for AF perpetuation. Baseline extent and the progression of LA fibrosis after ablation are strong predictors of postprocedural AF recurrence. Dronedarone is an antiarrhythmic drug proven to efficiently maintain sinus rhythm.
OBJECTIVE


We sought to investigate the effect of the antiarrhythmic drug Dronedarone in decreasing LA fibrosis progression and AF recurrence after ablation of AF patients.
METHODS


EDORA (NCT04704050) is a multicenter, prospective, randomized controlled clinical trial. Patients with persistent or paroxysmal AF undergoing AF ablation will be randomized into Dronedarone versus placebo/standard of care. The co-primary outcomes are the recurrence of atrial arrhythmias (AA) within 13 months of follow-up after ablation and the progression of left atrial fibrosis postablation. All patients will receive a late-gadolinium enhancement magnetic resonance imaging at baseline, 3- and 12-month follow-up for the quantification of LA fibrosis and ablation-related scarring. AA recurrence and burden will be assessed using a 30-day ECG patch every 3 months with daily ECG recordings in between. Quality of life improvement is assessed using the AFEQT and AFSS questionnaires.
CONCLUSION


EDORA will be the first trial to assess the progression of LA structural remodeling after ablation and its association with Dronedarone treatment and ablation success in a randomized controlled fashion. The trial will provide insight into the pathophysiology of AF recurrence after ablation and may provide potential therapeutic targets to optimize procedural outcomes.",2021,The co-primary outcomes are the recurrence of atrial arrhythmias (AA) within 13 months of follow-up after ablation and the progression of left atrial fibrosis postablation.,"['Patients with persistent or paroxysmal AF undergoing AF ablation', 'AF patients']","['Dronedarone', 'antiarrhythmic drug Dronedarone', 'Dronedarone versus placebo/standard of care', 'DrOnedarone']","['recurrence of atrial arrhythmias (AA', 'Quality of life improvement', 'atrial fibrosis progression and atrial fibrillation recurrence postablation', 'progression of LA fibrosis', 'progression of left atrial fibrosis postablation', 'LA fibrosis progression and AF recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205091', 'cui_str': 'Left'}]",,0.194835,The co-primary outcomes are the recurrence of atrial arrhythmias (AA) within 13 months of follow-up after ablation and the progression of left atrial fibrosis postablation.,"[{'ForeName': 'Nassir F', 'Initials': 'NF', 'LastName': 'Marrouche', 'Affiliation': 'Department of Cardiology, Tulane University School of Medicine, New Orleans, Los Angeles, USA.'}, {'ForeName': 'Lilas', 'Initials': 'L', 'LastName': 'Dagher', 'Affiliation': 'Department of Cardiology, Tulane University School of Medicine, New Orleans, Los Angeles, USA.'}, {'ForeName': 'Oussama', 'Initials': 'O', 'LastName': 'Wazni', 'Affiliation': 'Department of Cardiac Electrophysiology, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Nazem', 'Initials': 'N', 'LastName': 'Akoum', 'Affiliation': 'Department of Cardiology, University of Washington Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Moussa', 'Initials': 'M', 'LastName': 'Mansour', 'Affiliation': 'Department of Cardiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Abdel Hadi', 'Initials': 'AH', 'LastName': 'El Hajjar', 'Affiliation': 'Department of Cardiology, Tulane University School of Medicine, New Orleans, Los Angeles, USA.'}, {'ForeName': 'Arezu', 'Initials': 'A', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Cardiology, Tulane University School of Medicine, New Orleans, Los Angeles, USA.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Hua', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health, New Orleans, Los Angeles, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiovascular electrophysiology,['10.1111/jce.15274']
2001,34688915,Design of the Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure Trial (SPINE CARE) study: Methods and lessons from a multi-site pragmatic cluster randomized controlled trial.,"BACKGROUND


Low back and neck pain (together, spine pain) are among the leading causes of medical visits, lost productivity, and disability. For most people, episodes of spine pain are self-limited; nevertheless, healthcare spending for this condition is extremely high. Focusing care on individuals at high-risk of progressing from acute to chronic pain may improve efficiency. Alternatively, postural therapies, which are frequently used by patients, may prevent the overuse of high-cost interventions while delivering equivalent outcomes.
METHODS


The SPINE CARE (Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure) trial is a cluster-randomized multi-center pragmatic clinical trial designed to evaluate the clinical effectiveness and healthcare utilization of two interventions for primary care patients with acute and subacute spine pain. The study was conducted at 33 primary care clinics in geographically distinct regions of the United States. Individuals ≥18 years presenting to primary care with neck and/or back pain of ≤3 months' duration were randomized at the clinic-level to 1) usual care, 2) a risk-stratified, multidisciplinary approach called the Identify, Coordinate, and Enhance (ICE) care model, or 3) Individualized Postural Therapy (IPT), a standardized postural therapy method of care. The trial's two primary outcomes are change in function at 3 months and spine-related spending at one year. 2971 individuals were enrolled between June 2017 and March 2020. Follow-up was completed on March 31, 2021.
DISCUSSION


The SPINE CARE trial will determine the impact on clinical outcomes and healthcare costs of two interventions for patients with spine pain presenting to primary care.
TRIAL REGISTRATION NUMBER


NCT03083886.",2021,The SPINE CARE (Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure),"['primary care patients with acute and subacute spine pain', 'patients with spine pain presenting to primary care', '2971 individuals were enrolled between June 2017 and March 2020', '33 primary care clinics in geographically distinct regions of the United States', ""Individuals ≥18\xa0years presenting to primary care with neck and/or back pain of ≤3\xa0months' duration""]","['SPINE CARE (Spine Pain Intervention', 'multidisciplinary approach called the Identify, Coordinate, and Enhance (ICE) care model, or 3) Individualized Postural Therapy (IPT), a standardized postural therapy method of care', 'Spine Pain Intervention']","['Care Quality And Reduce Expenditure Trial (SPINE CARE', 'change in function at 3\xa0months and spine-related spending at one year', 'Care Quality And Reduce Expenditure']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0423673', 'cui_str': 'Pain in spine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0423673', 'cui_str': 'Pain in spine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",2971.0,0.123147,The SPINE CARE (Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure),"[{'ForeName': 'Niteesh K', 'Initials': 'NK', 'LastName': 'Choudhry', 'Affiliation': ""Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: nkchoudhry@bwh.harvard.edu.""}, {'ForeName': 'Constance P', 'Initials': 'CP', 'LastName': 'Fontanet', 'Affiliation': ""Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Ghazinouri', 'Affiliation': ""Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Fifer', 'Affiliation': 'Clinical Excellence Research Center, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Archer', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Physical Medicine and Rehabilitation, Osher Center for Integrative Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Haff', 'Affiliation': ""Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Butterworth', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Harvinder', 'Initials': 'H', 'LastName': 'Deogun', 'Affiliation': 'HonorHealth Clinical Research Institute, Scottsdale, Arizona, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Block', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Physical Medicine and Rehabilitation, Osher Center for Integrative Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Cooper', 'Affiliation': 'HonorHealth Clinical Research Institute, Scottsdale, Arizona, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Sears', 'Affiliation': ""Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Goyal', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Internal Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Rogelio A', 'Initials': 'RA', 'LastName': 'Coronado', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Physical Medicine and Rehabilitation, Osher Center for Integrative Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Schneider', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Hsu', 'Affiliation': 'Clinical Excellence Research Center, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Milstein', 'Affiliation': 'Clinical Excellence Research Center, Stanford University School of Medicine, Palo Alto, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106602']
2002,34679211,Associations of work-related stress and total sleep time with cholesterol levels in an occupational cohort of Japanese office workers.,"OBJECTIVE


The aim of the study was to investigate the associations of total sleep time (TST) and occupational stress based on the Brief Job Stress Questionnaire (BJSQ) with cholesterol levels in an occupational cohort of Japanese office workers.
METHODS


The present study is a secondary analysis of a subset of participants from a randomized controlled trial. Participants were 179 employees from 5 companies in Tokyo who participated as the intervention group in a 3-month lifestyle intervention study among office workers with metabolic syndrome or at risk of metabolic syndrome. All intervention-group participants used a mobile app and a wearable device. The final population for analysis in the present study were 173 participants. Cholesterol measures were derived from participants' annual health check-up data in the fiscal year preceding their inclusion in the study. Multiple linear regression models were used to determine the association between exposures and outcome.
RESULTS


Overall, stress levels were significantly and inversely associated with LDL-C (-7.12 mg/dl; 95% CI: -11.78, -2.45) and LDL-C/HDL-C ratio (-0.16 mg/dl; 95% CI: -0.27, -0.04) per standard deviation increase. Compared to average TST 5.9-7.2 hours, average TST of 4.0-5.3 hours (-4.82 mg/dl; 95% CI: -9.22, -0.43) was inversely associated with HDL-C.
CONCLUSION


Incremental increases of stress were significantly and inversely associated with LDL-C and LDL-C/HDL-C ratio. The shortest average TST was inversely associated with HDL-C. The results should be interpreted with care given certain methodological limitations.",2021,"Overall, stress levels were significantly and inversely associated with LDL-C (-7.12 mg/dl; 95% CI:","['occupational cohort of Japanese office workers', 'Participants were 179 employees from 5 companies in Tokyo who participated as the intervention group in a 3-month lifestyle intervention study among office workers with metabolic syndrome or at risk of metabolic syndrome', '173 participants']","['mobile app and a wearable device', 'Brief Job Stress Questionnaire (BJSQ) with cholesterol levels']","['stress', 'LDL-C/HDL-C ratio ', 'Overall, stress levels', 'shortest average TST', 'Cholesterol measures', 'total sleep time (TST) and occupational stress']","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}]",179.0,0.138411,"Overall, stress levels were significantly and inversely associated with LDL-C (-7.12 mg/dl; 95% CI:","[{'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Meguro', 'Affiliation': 'Precision Health, Department of Bioengineering, Graduate School of Engineering, The University of Tokyo, Bunkyo, Japan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Svensson', 'Affiliation': 'Precision Health, Department of Bioengineering, Graduate School of Engineering, The University of Tokyo, Bunkyo, Japan.'}, {'ForeName': 'Ung-Il', 'Initials': 'UI', 'LastName': 'Chung', 'Affiliation': 'Precision Health, Department of Bioengineering, Graduate School of Engineering, The University of Tokyo, Bunkyo, Japan.'}, {'ForeName': 'Akiko K', 'Initials': 'AK', 'LastName': 'Svensson', 'Affiliation': 'Precision Health, Department of Bioengineering, Graduate School of Engineering, The University of Tokyo, Bunkyo, Japan.'}]",Journal of occupational health,['10.1002/1348-9585.12275']
2003,34687910,Weight-Based Insulin During and After Intravenous Insulin Infusion Reduces Rates of Rebound Hyperglycemia When Transitioning to Subcutaneous Insulin in the Medical Intensive Care Unit.,"OBJECTIVE


Hyperglycemia often occurs after the transition from intravenous insulin infusion (IVII) to subcutaneous insulin. Weight-based basal insulin initiated earlier in the course of IVII in the medical intensive care unit (MICU), and a weight-based basal-bolus regimen after IVII, can potentially improve post-IVII glycemic control by 48 hours.
METHODS


This prospective study included 69 patients in MICU who were on IVII for ≥24 hours. Exclusions were end-stage renal disease, type 1 diabetes mellitus, and the active use of vasopressors. The intervention group received weight-based basal insulin (0.2-0.25 units/kg) with IVII and weight-based bolus insulin after IVII. The control group received current care. The primary end points were glucose levels at specific time intervals up to 48 hours after IVII.
RESULTS


There were 25 patients in the intervention group and 44 in the control group. The mean age of the patients was 59 ± 15 years, 32 (47%) were men, and 52 (78%) had prior diabetes mellitus. The 2 groups were not different (acute kidney injury/chronic kidney disease, pre-existing diabetes mellitus, illness severity, or nothing by mouth status after IVII), except for the steroid use, which was higher in the control group than in the intervention group (34% vs 12%, respectively). Glucose levels were not lower until 36 to 48 hours after IVII (166.8 ± 39.1 mg/dL vs 220.0 ± 82.9 mg/dL, P < .001). When controlling for body mass index, nutritional status, hemoglobin A1C, and steroid use, glucose level was lower starting at 12 to 24 hours out (166.87 mg/dL vs 207.50 mg/dL, P = .015). The frequency of hypoglycemia was similar between the 2 groups (5.0% vs 7.1%). The study did not reach target enrollment.
CONCLUSION


The addition of weight-based basal insulin during, and basal-bolus insulin immediately after, IVII in MICU results in better glycemic control at 24 hours after IVII with no increased hypoglycemia.",2021,"When controlling for BMI, nutritional status, HbA1c and steroid use, glucose was lower starting at 12-24 hours out (166.87 mg/dL vs 207.50 mg/dL, p=0.015).","['25 patients in the intervention and 44 in the control', 'Mean age was 59 ± 15 years old, 47% were male, and 78% had prior DM', '69 MICU patients on IVII for 24+ hours']","['current care', 'weight-based basal insulin']","['ESRD, T1DM, and active use of vasopressors', 'hypoglycemia', 'Hypoglycemia frequency', 'BMI, nutritional status, HbA1c and steroid use, glucose', 'Glucose levels', 'glucose at specific time intervals']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0439227', 'cui_str': 'hour'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",69.0,0.0492179,"When controlling for BMI, nutritional status, HbA1c and steroid use, glucose was lower starting at 12-24 hours out (166.87 mg/dL vs 207.50 mg/dL, p=0.015).","[{'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Cleveland Clinic, Cleveland, Ohio. Electronic address: zhouk2@ccf.org.'}, {'ForeName': 'Lauren Anne', 'Initials': 'LA', 'LastName': 'Buehler', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Tin', 'Initials': 'T', 'LastName': 'Zaw', 'Affiliation': 'Department of Hospital Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bena', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Lansang', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Cleveland Clinic, Cleveland, Ohio.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.1016/j.eprac.2021.10.003']
2004,34666182,Protocol for a randomized controlled trial of sitting reduction to improve cardiometabolic health in older adults.,"Older adults with obesity spend the majority of their waking hours sedentary. Given substantial barriers to regular physical activity in this population, approaches to reduce sedentary time could be an effective health promotion strategy. We present the protocol of a randomized controlled trial to reduce sitting time in older adults with a body mass index of 30 kg/m 2  or above. Participants (N = 284) will be randomized to receive a sitting reduction intervention (termed I-STAND) or a healthy living focused attention control condition. I-STAND includes 10 contacts with a health coach (10 sessions total) and participants receive a wrist-worn prompting device and portable standing desk. The healthy living condition includes 10 sessions with a health coach to set goals around various topics relating to healthy aging. Participants receive their assigned intervention for 6 months. After 6 months, those receiving the I-STAND condition are re-randomized to receive five booster health coaching sessions by 'phone or no further contact; healthy living participants receive no further contact and those in both conditions are followed for an additional 6 months. Measurements initially included wearing an activPAL device and completing several biometric tests (e.g., blood pressure, HbA1c), at baseline, 3 months, 6 months, and 12 months; however, during the COVID-19 pandemic we shifted to remote assessments and were unable to collect all of these measures. The primary outcomes remained activPAL-assessed sitting time and blood pressure. Recruitment is anticipated to be completed in 2022.",2021,Participants (N = 284) will be randomized to receive a sitting reduction intervention (termed I-STAND) or a healthy living focused attention control condition.,"['10 contacts with a health coach (10 sessions total) and participants receive a', 'older adults', 'Older adults with obesity spend the majority of their waking hours sedentary', 'older adults with a body mass index of 30\xa0kg/m 2  or above', 'Participants (N\xa0=\xa0284']","['sitting reduction', 'wrist-worn prompting device and portable standing desk', ""booster health coaching sessions by 'phone or no further contact; healthy living participants receive no further contact and those in both conditions are followed for an additional 6\xa0months"", 'sitting reduction intervention (termed I-STAND) or a healthy living focused attention control condition']","['wearing an activPAL device and completing several biometric tests (e.g., blood pressure, HbA1c', 'cardiometabolic health', 'activPAL-assessed sitting time and blood pressure', 'sitting time']","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0589098', 'cui_str': 'Focused attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",284.0,0.156854,Participants (N = 284) will be randomized to receive a sitting reduction intervention (termed I-STAND) or a healthy living focused attention control condition.,"[{'ForeName': 'Dori E', 'Initials': 'DE', 'LastName': 'Rosenberg', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave Suite 1600, Seattle, WA 98101, United States of America. Electronic address: Dori.E.Rosenberg@kp.org.'}, {'ForeName': 'Mikael Anne', 'Initials': 'MA', 'LastName': 'Greenwood-Hickman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave Suite 1600, Seattle, WA 98101, United States of America. Electronic address: Mikael.Anne.Greenwood-Hickman@kp.org.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave Suite 1600, Seattle, WA 98101, United States of America. Electronic address: Jing.Zhou@kp.org.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Cook', 'Affiliation': 'Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave Suite 1600, Seattle, WA 98101, United States of America. Electronic address: Andrea.J.Cook@kp.org.'}, {'ForeName': 'Kayne D', 'Initials': 'KD', 'LastName': 'Mettert', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave Suite 1600, Seattle, WA 98101, United States of America. Electronic address: Kayne.D.Mettert@kp.org.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cooper', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave Suite 1600, Seattle, WA 98101, United States of America. Electronic address: Julie.B.Cooper@kp.org.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Arterburn', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave Suite 1600, Seattle, WA 98101, United States of America. Electronic address: David.E.Arterburn@kp.org.'}, {'ForeName': 'Beverly B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave Suite 1600, Seattle, WA 98101, United States of America. Electronic address: Bev.B.Green@kp.org.'}, {'ForeName': 'Callie', 'Initials': 'C', 'LastName': 'Walsh-Bailey', 'Affiliation': 'Brown School, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO 63130, United States of America. Electronic address: callie.w@wustl.edu.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kerr', 'Affiliation': 'The Grant Doctor, San Diego, CA, United States of America. Electronic address: jkerr@grantdoctor.org.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Owen', 'Affiliation': 'Baker Heart and Diabetes Institute, PO Box 6492, Melbourne, Victoria 3004, Australia. Electronic address: Neville.Owen@baker.edu.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, PO Box 6492, Melbourne, Victoria 3004, Australia; Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, Australia. Electronic address: David.Dunstan@baker.edu.au.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave Suite 1600, Seattle, WA 98101, United States of America. Electronic address: Jennifer.B.McClure@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106593']
2005,34690120,Improved Executive Functions and Reduced Craving in Youths with Methamphetamine Addiction: Evidence from Combined Transcranial Direct Current Stimulation with Mindfulness Treatment.,"Objective


Transcranial direct current stimulation (tDCS) and mindfulness practices have been proposed as a potential approach to improve executive functions (EFs) and reduce craving in persons with substance use disorders. Based on the neural mechanisms of action of each of these interventions, the combination of both non-pharmacological interventions might have additive effects. In the current study, the effects of tDCS combined with mindfulness-based substance abuse treatment (MBSAT) to improve EFs and reduce craving were investigated in early abstinent methamphetamine abuse.
Methods


Eighty (youths aged between 18 and 21) early-abstinent methamphetamine users were randomly assigned to the research groups (tDCS group [n = 20], mindfulness group [n = 20], combined mindfulness-tDCS group [n = 20], and sham group [n = 20]). Active tDCS (1.5 mA,20 min, 12 sessions) or sham tDCS was appliedover the left dorsolateral prefrontal cortex and the MBSAT protocol was used over twelve 50-min sessions.
Results


Both in the post-test phase (immediately after the intervention) and follow-up phase (one month after the intervention), performance in most EFs tasks significantly improved in the combination group which received real tDCS ＋ MBSAT, as compared to baseline values and sham stimulation group. Similarly, a significant reduction in craving was observed after intervention inall treatment groups, but not the sham stimulation group. Interestingly, the increase in EFs and the reduction in craving post versus pre tDCS ＋ MBSAT intervention were correlated.
Conclusion


Findings from the current study provide initial support for the clinical effectiveness of combination tDCS ＋ MBSAT, possibly influencing cognitive/affective processes.",2021,"Similarly, a significant reduction in craving was observed after intervention inall treatment groups, but not the sham stimulation group.","['early-abstinent methamphetamine users', 'Youths with Methamphetamine Addiction', 'persons with substance use disorders', 'Methods\n\n\nEighty (youths aged between 18 and 21']","['tDCS combined with mindfulness-based substance abuse treatment (MBSAT', 'research groups (tDCS group [n = 20], mindfulness group [n = 20], combined mindfulness-tDCS', 'Active tDCS', 'Transcranial direct current stimulation (tDCS) and mindfulness practices']","['Improved Executive Functions and Reduced Craving', 'craving']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",80.0,0.0311586,"Similarly, a significant reduction in craving was observed after intervention inall treatment groups, but not the sham stimulation group.","[{'ForeName': 'Jaber', 'Initials': 'J', 'LastName': 'Alizadehgoradel', 'Affiliation': 'Department of Clinical and Health Psychology, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Imani', 'Affiliation': 'Department of Clinical and Health Psychology & Counseling Group, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Education & Psychology, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Molaei', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Psychology, Mohaghegh-Ardabili University, Ardabil, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Taherifard', 'Affiliation': 'Department of Psychology, Mohaghegh-Ardabili University, Ardabil, Iran.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2021.19.4.653']
2006,34687253,Evaluation of LL-37 in healing of hard-to-heal venous leg ulcers: A multicentric prospective randomized placebo-controlled clinical trial.,"Many patients with venous leg ulcers do not reach complete healing with compression treatment alone, which is current standard care. This clinical trial HEAL LL-37 was a phase IIb double-blind, randomized, placebo-controlled study, with the aim to evaluate the efficacy and safety of a new drug LL-37 for topical administration, in combination with compression therapy, in 148 patients suffering from hard-to-heal venous leg ulcers. The study had three arms, consisting of two groups treated with LL-37 at concentrations of 0.5 or 1.6 mg/mL, and a placebo cohort. Patients had a mean age of 67.6 years, a median ulcer duration of 20.3 months, and a mean wound size at the time of randomization of 11.6 cm 2  . Efficacy analysis performed on the full study population did not identify any significant improvement in healing in patients treated with LL-37 as compared with the placebo. In contrast, a post hoc analysis revealed statistically significant improvement with LL-37 treatment in several interrelated healing parameters in the subgroup of patients with large target wounds (a wound area of at least 10 cm 2  at randomization), which is a known negative prognostic factor for healing. The study drug was well tolerated and safe in both dose strengths. In summary, this clinical trial did not detect any significant differences in healing of venous lower leg ulcers in the entire study cohort comparing patients treated with LL-37 versus placebo. A subgroup analysis provided an interesting observation that LL-37 could offer a treatment benefit in patients with large ulcers, exigently warranting a further study adequately powered to statistically assess the treatment outcome in this patient group.",2021,Efficacy analysis performed on the full study population did not identify any significant improvement in healing in patients treated with LL-37 as compared with the placebo.,"['Patients had a mean age of 67.6\u2009years, a median ulcer duration of 20.3\xa0months, and a mean wound size at the time of randomization of 11.6\xa0cm 2  ', '148 patients suffering from hard-to-heal venous leg ulcers', 'healing of hard-to-heal venous leg ulcers', 'patients with large ulcers', 'patients with venous leg ulcers']","['LL-37 versus placebo', 'compression therapy', 'LL-37', 'placebo']","['tolerated and safe', 'healing of venous lower leg ulcers', 'efficacy and safety', 'healing']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",148.0,0.0713335,Efficacy analysis performed on the full study population did not identify any significant improvement in healing in patients treated with LL-37 as compared with the placebo.,"[{'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Mahlapuu', 'Affiliation': 'Promore Pharma AB, Stockholm, Sweden.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sidorowicz', 'Affiliation': 'ETG Warsaw, Warsaw, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Mikosinski', 'Affiliation': 'NZOZ MIKOMED, Łódź, Poland.'}, {'ForeName': 'Mikołaj', 'Initials': 'M', 'LastName': 'Krzyżanowski', 'Affiliation': 'Allmedica Badania Kliniczne, Nowy Targ, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Orleanski', 'Affiliation': 'EZ-MED Swidnica, Swidnica, Poland.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Twardowska-Saucha', 'Affiliation': 'Specjalistyczna Pomoc Medyczna, Zabrze, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Nykaza', 'Affiliation': 'Centrum Medyczne Pratia Warszawa, Warsaw, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Dyaczynski', 'Affiliation': 'Centrum Medyczne Angelius Provita, Katowice, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Belz-Lagoda', 'Affiliation': 'ETG Zamość, Zamość, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Dziwiszek', 'Affiliation': 'CM Pratia Ostrołęka, Ostrołęka, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Kujawiak', 'Affiliation': 'ETG Siedlce, Siedlce, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Karczewski', 'Affiliation': 'Solumed Centrum Medyczne, Poznań, Poland.'}, {'ForeName': 'Folke', 'Initials': 'F', 'LastName': 'Sjöberg', 'Affiliation': 'Burn Center, Linköping University Hospital, Linköping, Sweden.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Grzela', 'Affiliation': 'Clinic of Phlebology and the Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Wegrzynowski', 'Affiliation': 'Angiodiabetica Vascular and Diabetic Foot Clinic, Poznan, Poland.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Thunarf', 'Affiliation': 'LINK Medical Research AB, Uppsala, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Björk', 'Affiliation': 'Promore Pharma AB, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ekblom', 'Affiliation': 'Promore Pharma AB, Stockholm, Sweden.'}, {'ForeName': 'Arkadiusz', 'Initials': 'A', 'LastName': 'Jawien', 'Affiliation': 'Department of Vascular Surgery and Angiology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Torun, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Apelqvist', 'Affiliation': 'Department of Endocrinology, University Hospital of Malmö, Malmö, Sweden.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12977']
2007,34688088,Factors influencing perinatal outcomes in women with preterm preeclampsia: A secondary analysis of the PHOENIX trial.,"This secondary analysis of the PHOENIX trial (evaluating planned delivery against expectant management in late preterm preeclampsia) demonstrates that in women who started induction of labour, 63% of women delivered vaginally (56% at 34 weeks' gestation). Compared to expectant management, planned delivery was associated with higher rates of neonatal unit admission for prematurity (but lower proportions of small-for-gestational age infants); length of neonatal unit stay and neonatal morbidity (including respiratory support) were similar across both intervention groups at all gestational windows. Neonatal unit admission was increased by earlier gestation at delivery, development of severe preeclampsia, and being small-for-gestational age.",2021,"Compared to expectant management, planned delivery was associated with higher rates of neonatal unit admission for prematurity (but lower proportions of small-for-gestational age infants); length of neonatal unit stay and neonatal morbidity (including respiratory support) were similar across both intervention groups at all gestational windows.","['women with preterm preeclampsia', 'late preterm preeclampsia', ""women who started induction of labour, 63% of women delivered vaginally (56% at 34\xa0weeks' gestation""]",['planned delivery against expectant management'],"['Neonatal unit admission', 'neonatal unit stay and neonatal morbidity', 'rates of neonatal unit admission for prematurity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]",,0.0991361,"Compared to expectant management, planned delivery was associated with higher rates of neonatal unit admission for prematurity (but lower proportions of small-for-gestational age infants); length of neonatal unit stay and neonatal morbidity (including respiratory support) were similar across both intervention groups at all gestational windows.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fleminger', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Duhig', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brocklehurst', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'Action on Pre-Eclampsia, Evesham, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Marlow', 'Affiliation': ""ULC EGA Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK. Electronic address: lucy.chappell@kcl.ac.uk.""}]",Pregnancy hypertension,['10.1016/j.preghy.2021.10.002']
2008,34688281,Scale-up of the Physical Activity 4 Everyone (PA4E1) intervention in secondary schools: 24-month implementation and cost outcomes from a cluster randomised controlled trial.,"BACKGROUND


Physical Activity 4 Everyone (PA4E1) is an evidence-based program effective at increasing adolescent physical activity (PA) and improving weight status. This study aimed to determine a) the effectiveness of an adapted implementation intervention to scale-up PA4E1 at 24-month follow-up, b) fidelity and reach, and c) the cost and cost-effectiveness of the implementation support intervention.
METHODS


A cluster randomised controlled trial using a type III hybrid implementation-effectiveness design in 49 lower socio-economic secondary schools, randomised to a program (n = 24) or control group (n = 25). An adapted implementation intervention consisting of seven strategies was developed to support schools to implement PA4E1 over 24-months. The primary outcome was the proportion of schools implementing at least four of the 7 PA practices, assessed via computer assisted telephone interviews (CATI) with Head Physical Education Teachers. Secondary outcomes included the mean number of PA practices implemented, fidelity and reach, cost and cost-effectiveness. Logistic regression models assessed program effects.
RESULTS


At baseline, no schools implemented four of the 7 PA practices. At 24-months, significantly more schools in the program group (16/23, 69.6%) implemented at least four of the 7 PA practices than the control group (0/25, 0%) (p < 0.001). At 24-months, program schools were implementing an average of 3.6 more practices than control schools (4.1 (1.7) vs. 0.5 (0.8), respectively) (P < 0.001). Fidelity and reach of the implementation intervention were high (> 75%). The total cost of the program was $415,112 AUD (2018) ($17,296 per school; $117.30 per student).
CONCLUSIONS


The adapted implementation intervention provides policy makers and researchers with an effective and potentially cost-effective model for scaling-up the delivery of PA4E1 in secondary schools. Further assessment of sustainability is warranted.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12617000681358 prospectively registered 12th May 2017.",2021,"At 24-months, significantly more schools in the program group (16/23, 69.6%) implemented at least four of the 7 PA practices than the control group (0/25, 0%) (p < 0.001).","['49 lower socio-economic secondary schools, randomised to a program (n\u2009=\u200924) or control group (n\u2009=\u200925']",['Physical Activity 4 Everyone (PA4E1) intervention'],"['proportion of schools implementing at least four of the 7 PA practices, assessed via computer assisted telephone interviews (CATI) with Head Physical Education Teachers', 'cost and cost-effectiveness', 'adolescent physical activity (PA) and improving weight status', 'Fidelity and reach of the implementation intervention', 'mean number of PA practices implemented, fidelity and reach, cost and cost-effectiveness', 'total cost']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",49.0,0.0450525,"At 24-months, significantly more schools in the program group (16/23, 69.6%) implemented at least four of the 7 PA practices than the control group (0/25, 0%) (p < 0.001).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Campbell', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McLaughlin', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Matthew.Mclaughlin1@health.nsw.gov.au.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nathan', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Health Behaviour, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre for Health Behaviour, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gillham', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, 2305, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Searles', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, 2305, Australia.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Reeves', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'South Western Sydney Local Health District, Locked Mail Bag, 7279, BC1871, Liverpool, NSW, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Evans', 'Affiliation': 'Central Coast Local Health District, 4-6 Watt Street, Gosford, NSW, 2250, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': 'Mid North Coast Local Health District, P.O. Box 126, Port Macquarie, NSW, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Boyer', 'Affiliation': 'New South Wales Department of Education, School Sports Unit, Level 3, 1 Oxford Street, Darlinghurst, NSW, 2010, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Davies', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'McKenzie', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Robertson', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-021-01206-8']
2009,34688948,T cell receptor repertoires as potential diagnostic markers for patients with COVID-19.,"OBJECTIVE


Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an ongoing global health emergency. T cell receptor (TCR) are crucial mediators of antiviral adaptive immunity. Here, we sought to comprehensively characterize the TCR repertoire changes in patients with COVID-19.
DESIGN


We implemented a large sample size multi-center randomized controlled trial to study the TCR repertoire features, and identify COVID-19 disease-related TCR sequences.
RESULTS


We found that some TCRβ features of COVID-19 patients were remarkably different from that of healthy control, including decreased repertoire diversity, longer CDR3 length, skewed utilization of the TRBV/J, and a high degree of TCRβ sharing. Moreover, this analysis showed TCR repertoire diversity declines with aging, which may be a cause of higher infection and mortality in elderly patients. Importantly we identified a set of TCRβ clones, which can distinguish COVID-19 patients from healthy controls with high accuracy. Notably, this diagnostic model demonstrates 100% specificity and 82.68% sensitivity at 0-3 days post diagnosis.
CONCLUSIONS


This study lay the foundation for immunodiagnosis and the development of medicines and vaccines for COVID-19 patients.",2021,"Importantly we identified a set of TCRβ clones, which can distinguish COVID-19 patients from healthy controls with high accuracy.","['COVID-19 patients', 'patients with COVID-19', 'elderly patients']",[],"['repertoire diversity, longer CDR3 length, skewed utilization of the TRBV/J', 'TCR repertoire changes']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034790', 'cui_str': 'T-cell antigen receptor'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.128655,"Importantly we identified a set of TCRβ clones, which can distinguish COVID-19 patients from healthy controls with high accuracy.","[{'ForeName': 'Xianliang', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Central Laboratory, Guangxi Health Commission Key Laboratory of Glucose and Lipid Metabolism Disorders, the Second Affiliated Hospital of Guilin Medical University, Guilin, 541199, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Guangzhou Huayin Health Medical Group Co., Ltd (Guangzhou, China).'}, {'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'College of Laboratory Medicine, Guilin Medical University, Guilin, 541199, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of State owned Assets Management, Affiliated Hospital of Guilin Medical University, Guilin, 541001, China.'}, {'ForeName': 'Chune', 'Initials': 'C', 'LastName': 'Mo', 'Affiliation': 'Central Laboratory, Guangxi Health Commission Key Laboratory of Glucose and Lipid Metabolism Disorders, the Second Affiliated Hospital of Guilin Medical University, Guilin, 541199, China.'}, {'ForeName': 'Yongsi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Guangzhou Huayin Health Medical Group Co., Ltd (Guangzhou, China).'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Central Laboratory, Guangxi Health Commission Key Laboratory of Glucose and Lipid Metabolism Disorders, the Second Affiliated Hospital of Guilin Medical University, Guilin, 541199, China.'}, {'ForeName': 'Xuyan', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'Department of pathology, Affiliated Hospital of Guilin Medical University, Guilin, 541001.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Guangzhou Huayin Health Medical Group Co., Ltd (Guangzhou, China).'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'He', 'Affiliation': 'Guangzhou Huayin Health Medical Group Co., Ltd (Guangzhou, China).'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Mo', 'Affiliation': 'Clinical Laboratory, the Second Affiliated Hospital of Guilin Medical University, Guilin, 541199.'}, {'ForeName': 'Shaofeng', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Guangxi Key Laboratory of Tumor Immunology and Microenvironmental Regulation, Guilin Medical University, Guilin, Guangxi, 541199, China.'}, {'ForeName': 'Minglin', 'Initials': 'M', 'LastName': 'Ou', 'Affiliation': 'Central Laboratory, Guangxi Health Commission Key Laboratory of Glucose and Lipid Metabolism Disorders, the Second Affiliated Hospital of Guilin Medical University, Guilin, 541199, China. Electronic address: minglinou@glmc.edu.cn.'}, {'ForeName': 'Haonan', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Clinical Laboratory, The Affiliated Hospital of Guilin Medical University, Guilin, Guangxi, 541001, China. Electronic address: guohaonan@glmc.edu.cn.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Laboratory Medicine, the Second Affiliated Hospital of Guilin Medical University, Guilin, 541199, China. Electronic address: hbliu@glmc.edu.cn.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.10.033']
2010,34688887,Aging impairs fibrosis-4 index after sustained virologic response by direct-acting antivirals in chronic hepatitis C infection.,"INTRODUCTION AND OBJECTIVES


Sustained virologic response (SVR) is achieved in most cases of C-type liver disease after direct-acting antiviral (DAA) therapy. Although liver fibrosis improves, the degree of improvement is different. This study aimed to analyze the factors involved in improving liver fibrosis using the fibrosis 4 (FIB-4) index.
MATERIAL AND METHODS


Patients were monitored for >3 years after SVR. At the start of therapy (SOT), liver fibrosis was categorized as either mild (<1.45 n = 28), moderate (1.45-3.25 n = 139), or advanced (>3.25 n = 236) based on the FIB-4 index. The FIB-4 index in the advanced group decreased significantly compared to that of the other two, so we selected the advanced group as the analysis target. SOT and end of therapy (EOT) factors that contributed to the FIB-4 index ≤3.25 at 3 years after therapy were examined using a multivariate analysis.
RESULTS


Among the SOT factors, age (<72 years old), absence of liver cirrhosis (LC), alanine transferase (ALT) (≥50 U/L), platelet (PLT) (≥10.2 × 10 4 /mm 3 ), and total bilirubin (T.Bil) (<0.8 mg/dl) were the significant factors contributing to the improvement of the FIB-4 index. Among the EOT factors, age (<72 years), PLT (≥12.0 × 10 4 /mm3), and hemoglobin (Hb) (≥12.1 g/dl) were the significant factors contributing to the improvement of FIB-4 index.
CONCLUSIONS


Factors involved in the improvement of liver fibrosis after SVR were young age, absence of LC, low T.Bil., high ALT, high PLT, and high Hb levels. The levels of T.Bil, PLT, and Hb were considered to be related to portal hypertension. Aging strongly impaired the improvement in liver fibrosis.",2021,"The FIB-4 index in the advanced group decreased significantly compared to that of the other two, so we selected the advanced group as the analysis target.","['chronic hepatitis C infection', 'Patients were monitored for >3 years after SVR']",[],"['absence of liver cirrhosis (LC), alanine transferase (ALT) (≥50 U/L), platelet (PLT', 'total bilirubin (T.Bil', 'liver fibrosis', 'levels of T.Bil, PLT, and Hb', 'FIB-4 index', 'SOT and end of therapy (EOT) factors']","[{'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}]",[],"[{'cui': 'C0266258', 'cui_str': 'Congenital absence of liver'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0376147', 'cui_str': 'SGPT'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4304377', 'cui_str': 'Fibrosis-4 index'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444930', 'cui_str': 'End'}]",,0.0146897,"The FIB-4 index in the advanced group decreased significantly compared to that of the other two, so we selected the advanced group as the analysis target.","[{'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Department of Hepatology, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoshiyasu', 'Initials': 'Y', 'LastName': 'Karino', 'Affiliation': 'Department of Hepatology, Sapporo Kosei General Hospital, Sapporo, Japan; Department of Gastroenterology, Keiyukai Sapporo Hospital, Sapporo, Japan. Electronic address: ykarino@keiyukaisapporo.or.jp.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Hige', 'Affiliation': 'Department of Hepatology, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Suii', 'Affiliation': 'Department of Hepatology, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Tatsumi', 'Affiliation': 'Department of Hepatology, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Hepatology, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Arakawa', 'Affiliation': 'Department of Hepatology, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Kuwata', 'Affiliation': 'Department of Hepatology, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Joji', 'Initials': 'J', 'LastName': 'Toyota', 'Affiliation': 'Department of Hepatology, Sapporo Kosei General Hospital, Sapporo, Japan.'}]",Annals of hepatology,['10.1016/j.aohep.2021.100566']
2011,34689383,Decreased frequency of transplantation and lower post-transplant survival free of re-transplantation in LVAD patients with the new heart transplant allocation system.,"PURPOSE


To evaluate the effect of the new heart transplant (HT) allocation system in left ventricular assist device (LVAD) supported patients listed as bridge to transplantation (BTT).
METHODS


Adult patients who were listed for HT between October 18, 2016 and October 17, 2019, and were supported with an LVAD, enrolled in the UNOS database were included in this study. Patients were classified in the old or new system if they were listed or transplanted before or after October 18, 2018, respectively.
RESULTS


A total of 3261 LVAD patients were listed for transplant. Of these, 2257 were classified in the old and 1004 in the new system. The cumulative incidence of death or removal from the transplant list due to worsening clinical status at 360-days after listing was lower in the new system (4% vs. 7%, P = .011). LVAD Patients listed in the new system had a lower frequency of transplantation within 360-days of listing (52% vs. 61%, P < .001). A total of 1843 LVAD patients were transplanted, 1004 patients in the old system and 839 patients in the new system. The post-transplant survival at 360 days was similar between old and new systems (92.3% vs. 90%, P = .08). However, LVAD patients transplanted in the new system had lower frequency of the combined endpoint, freedom of death or re-transplantation at 360 days (92.2% vs. 89.6%, P = .046).
CONCLUSION


The new HT allocation system has affected the LVAD-BTT population significantly. On the waitlist, LVAD patients have a decreased cumulative frequency of transplantation and a concomitant decrease in death or delisting due to worsening status. In the new system, LVAD patients have a decreased survival free of re-transplantation at 360 days post-transplant.",2021,"In the new system, LVAD patients have a decreased survival free of re-transplantation at 360 days post-transplant.","['2257 were classified in the old and 1004 in the new system', 'Adult patients who were listed for HT between October 18, 2016 and October 17, 2019, and were supported with an LVAD, enrolled in the UNOS database were included in this study', 'left ventricular assist device (LVAD) supported patients listed as bridge to transplantation (BTT', 'Patients were classified in the old or new system if they were listed or transplanted before or after October 18, 2018, respectively', '1843 LVAD patients were transplanted, 1004 patients in the old system and 839 patients in the new system', 'LVAD patients with the New Heart Transplant Allocation System', '3261 LVAD patients were listed for transplant']","['LVAD', 'new heart transplant (HT) allocation system']","['cumulative incidence of death or removal', 'post-transplant survival', 'cumulative frequency of transplantation', 'death', 'freedom of death or re-transplantation', 'survival free of re-transplantation']","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",3261.0,0.0590323,"In the new system, LVAD patients have a decreased survival free of re-transplantation at 360 days post-transplant.","[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Jani', 'Affiliation': 'Advanced Heart Failure Section, Spectrum Health, Grand Rapids, Michigan, USA.'}, {'ForeName': 'Sangjin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Advanced Heart Failure Section, Spectrum Health, Grand Rapids, Michigan, USA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Acharya', 'Affiliation': 'Sarver Heart Center, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hoeksema', 'Affiliation': 'Advanced Heart Failure Section, Spectrum Health, Grand Rapids, Michigan, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Boeve', 'Affiliation': 'Division of Cardio Thoracic Surgery, Spectrum Health, Grand Rapids, Michigan, USA.'}, {'ForeName': 'Marzia', 'Initials': 'M', 'LastName': 'Leacche', 'Affiliation': 'Division of Cardio Thoracic Surgery, Spectrum Health, Grand Rapids, Michigan, USA.'}, {'ForeName': 'Nabin K', 'Initials': 'NK', 'LastName': 'Manandhar-Shrestha', 'Affiliation': 'Department of Cardiovascular Research, Spectrum Health, Grand Rapids, Michigan, USA.'}, {'ForeName': 'Stefan V', 'Initials': 'SV', 'LastName': 'Jovinge', 'Affiliation': 'Frederik Meijer Heart and Vascular Institute, Spectrum Health, Grand Rapids, Michigan, USA.'}, {'ForeName': 'Renzo Y', 'Initials': 'RY', 'LastName': 'Loyaga-Rendon', 'Affiliation': 'Advanced Heart Failure Section, Spectrum Health, Grand Rapids, Michigan, USA.'}]",Clinical transplantation,['10.1111/ctr.14493']
2012,34693757,Design of placebo-controlled randomized trials of anticancer agents: Ethical considerations based on a review of published trials.,"BACKGROUND


Limited information exists about the design of placebo-controlled cancer trials. Through a systematic review of trials published in 2013, we describe placebo use in randomized trials testing anticancer agents and analyze strategies that increase exposure to the experimental regimen.
METHODS


Trials were classified as add-on (placebo in combination with standard treatment) or placebo-only. Strategies to allow more than half of the participants to receive the experimental regimen were reviewed. The risk-benefit ratio of receiving the experimental agent was considered favorable if the difference in primary outcome was significant (p ≤ 0.05), neutral if there was no significant difference in the primary outcome and the experimental agent did not add substantial toxicity, and unfavorable otherwise.
RESULTS


Eighty trials were included (32,694 participants). Most trials were add-on (69%). The risk-benefit outcome was favorable, neutral, and unfavorable to the experimental agent in 52%, 32%, and 16% of placebo-only trials and 25%, 53%, and 22%, respectively, of add-on trials. Four strategies increased exposure to the experimental regimen: one-way crossover (23%), uneven randomization (21%), three-arms (13%), and randomized discontinuation design (4%); these strategies were used more often in placebo-only trials.
CONCLUSION


A minority of participants received placebo alone and strategies to increase experimental exposure were used commonly. Fewer than half of the studies had favorable outcomes, thus defending the use of placebo controls, when there is no established treatment. Strategies that increase patient exposure to experimental agents rather than placebo may expose them to non-beneficial, sometimes toxic, experimental agents.",2021,"The risk-benefit outcome was favorable, neutral, and unfavorable to the experimental agent in 52%, 32%, and 16% of placebo-only trials and 25%, 53%, and 22%, respectively, of add-on trials.","['Eighty trials were included (32,694 participants']","['placebo', 'placebo in combination with standard treatment) or placebo-only']","['substantial toxicity, and unfavorable otherwise']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}]",32694.0,0.570548,"The risk-benefit outcome was favorable, neutral, and unfavorable to the experimental agent in 52%, 32%, and 16% of placebo-only trials and 25%, 53%, and 22%, respectively, of add-on trials.","[{'ForeName': 'Adélaïde', 'Initials': 'A', 'LastName': 'Doussau', 'Affiliation': 'Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Isha', 'Initials': 'I', 'LastName': 'Agarwal', 'Affiliation': 'Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tito', 'Initials': 'T', 'LastName': 'Fojo', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Columbia University in the City of New York, New York, NY, USA.'}, {'ForeName': 'Ian F', 'Initials': 'IF', 'LastName': 'Tannock', 'Affiliation': 'Princess Margaret Cancer Center and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Grady', 'Affiliation': 'Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}]","Clinical trials (London, England)",['10.1177/17407745211052474']
2013,34694215,Exploring the Role of Traumatic Event Exposure in Tobacco Dependence Treatment Outcomes Among African Americans.,"African Americans are more likely to die from tobacco-related diseases and less likely to quit smoking than their white counterparts. Evidence of greater prevalence of posttraumatic stress disorder (PTSD) among African Americans underscores the importance of studying the effects of traumatic event exposure on tobacco dependence treatment outcomes in this group. In this secondary analysis of data from a previously completed randomized control trial, we examined the effects of traumatic event exposure (e.g., serious accident) on tobacco dependence treatment outcomes, as well its moderating effects on the effectiveness of an adapted smoking cessation treatment, in a sample ( n  = 169) of African American smokers in New York City. Traumatic event exposure did not have a significant impact on tobacco treatment outcomes and did not moderate the relationship between treatment type and outcomes in this sample. While results may be driven by unique sample characteristics, they may also indicate that an average level of traumatic event exposure does not significantly impact tobacco treatment outcomes among African Americans. Future research should examine the effects of higher levels of traumatic event exposure on treatment outcomes, as well as investigating the factors underlying trauma-exposed individuals' difficulties with reducing/quitting smoking in a larger, more diverse African American sample.",2021,Traumatic event exposure did not have a significant impact on tobacco treatment outcomes and did not moderate the relationship between treatment type and outcomes in this sample.,"['African Americans', 'a sample ( n  =\xa0169) of African American smokers in New York City']",['adapted smoking cessation treatment'],[],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.038292,Traumatic event exposure did not have a significant impact on tobacco treatment outcomes and did not moderate the relationship between treatment type and outcomes in this sample.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shevorykin', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Ruglass', 'Affiliation': 'Department of Psychology, The City College of New York, City University of New York, New York, NY, USA.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Mancini', 'Affiliation': 'Department of Mental Health Counseling, Pace University, Pleasantville, NY, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carl', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Legg', 'Affiliation': 'Department of Mental Health Counseling, Pace University, Pleasantville, NY, USA.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Sheffer', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}]",Journal of psychoactive drugs,['10.1080/02791072.2021.1985661']
2014,34689837,The effect of rehabilitation protocol using mobile health in overweight and obese patients with knee osteoarthritis: a clinical trial.,"OBJECTIVE


The objective of this randomized controlled trial (RCT) was to investigate the effectiveness of the lower limb rehabilitation protocol (LLRP) combined with mobile health (mHealth) applications on knee pain, mobility, functional activity and activities of daily living (ADL) among knee osteoarthritis (OA) patients who were overweight and obese.
METHODS


This study was a single-blind, RCT conducted at Teaching Bay of Rehmatul-Lil-Alameen Post Graduate Institute of Cardiology between February and November 2020. 114 knee OA patients who were overweight and obese were randomly divided by a computer-generated number into the rehabilitation group with mHealth (RGw-mHealth) to receive LLRP + instructions of daily care (IDC) combined with mHealth intervention, rehabilitation group without mHealth (RGwo-mHealth) to receive LLRP + IDC intervention and control group (CG) to receive IDC intervention. All three groups were also provided leaflets explaining about their intervention. The primary outcome measure was knee pain measured by the Western Ontario and McMaster Universities Osteoarthritis Index score. The secondary outcome measures were mobility measured by the Timed up and go (TUG) test, functional activity measured by the patient-specific functional scale (PSFS), and ADL measured by the Katz Index of independence in ADL scores.
RESULTS


Among the 114 patients who were randomized (mean age, 53 years), 96 (84%) completed the trial. After 3-months of intervention, patients in all three groups had statistically significant knee pain reduction (RGw-mHealth: 2.54; RGwo-mHealth: 1.47; and CG: 0.37) within groups (P < 0.05). Furthermore, patients in the RGw-mHealth and RGwo-mHealth had statistically significant improvement in mobility, functional activity, and ADL within groups (P < 0.05), but no improvement was noted in the CG (p > 0.05). As indicated in the overall analysis of covariance, there were statistically significant differences in the mean knee pain, mobility, functional activity, and ADL changes between groups after 3-months (p < 0.001). The pairwise between-group comparisons (Bonferroni post hoc analysis) of the knee pain, mobility, functional activity, and ADL scores at 3-months revealed that patients in the RGw-mHealth had significantly higher mean change in the knee pain, TUG test, functional activity, and ADL scores compared to patients in the RGwo-mHealth or CG.
CONCLUSION


Reduction in knee pain, improvement in mobility, functional activity, and ADL were more among patients in the RGw-mHealth compared with the RGwo-mHealth or CG. Trial registration National Medical Research Registry: NMRR-20-1094-52911. Date of registration: 05-05-2020. URL: https://www.nmrr.gov.my .",2021,"After 3-months of intervention, patients in all three groups had statistically significant knee pain reduction (RGw-mHealth: 2.54; RGwo-mHealth: 1.47; and CG: 0.37) within groups (P < 0.05).","['114 patients who were randomized (mean age, 53\xa0years), 96 (84%) completed the trial', 'Teaching Bay of Rehmatul-Lil-Alameen Post Graduate Institute of Cardiology between February and November 2020', '114 knee OA patients who were overweight and obese', 'overweight and obese patients with knee osteoarthritis', 'knee osteoarthritis (OA) patients who were overweight and obese']","['lower limb rehabilitation protocol (LLRP) combined with mobile health (mHealth) applications', 'computer-generated number into the rehabilitation group with mHealth (RGw-mHealth) to receive LLRP\u2009+ instructions of daily care (IDC) combined with mHealth intervention, rehabilitation group without mHealth (RGwo-mHealth) to receive LLRP\u2009+\u2009IDC intervention and control group (CG) to receive IDC intervention', 'rehabilitation protocol']","['knee pain, mobility, functional activity, and ADL scores', 'mobility measured by the Timed up and go (TUG) test, functional activity measured by the patient-specific functional scale (PSFS), and ADL measured by the Katz Index of independence in ADL scores', 'mobility, functional activity, and ADL', 'knee pain, TUG test, functional activity, and ADL scores', 'knee pain, mobility, functional activity and activities of daily living (ADL', 'mean knee pain, mobility, functional activity, and ADL changes', 'knee pain measured by the Western Ontario and McMaster Universities Osteoarthritis Index score', 'knee pain, improvement in mobility, functional activity, and ADL', 'knee pain reduction']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale'}, {'cui': 'C0451239', 'cui_str': 'Katz activities of daily living'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0677267,"After 3-months of intervention, patients in all three groups had statistically significant knee pain reduction (RGw-mHealth: 2.54; RGwo-mHealth: 1.47; and CG: 0.37) within groups (P < 0.05).","[{'ForeName': 'Muhammad Tariq', 'Initials': 'MT', 'LastName': 'Rafiq', 'Affiliation': 'Centre for Sport and Exercise Sciences, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohamad Shariff', 'Initials': 'MS', 'LastName': 'Abdul Hamid', 'Affiliation': 'Sports Medicine Department, University of Malaya Medical Centre, Kuala Lumpur, Malaysia. ayip@um.edu.my.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Hafiz', 'Affiliation': 'Sports Centre, Centre for Sport and Exercise Sciences, University of Malaya, Kuala Lumpur, Malaysia.'}]","Advances in rheumatology (London, England)",['10.1186/s42358-021-00221-4']
2015,34690126,Effects of Iron Supplementation on Attention Deficit Hyperactivity Disorder in Children Treated with Methylphenidate.,"Objective


To evaluate the effect of iron on the attention deficit hyperactivity disorder, treated with methylphenidate.
Methods


This double-blind, randomized placebo-controlled clinical trial was performed on 50 children with attention deficit hyperactivity disorder under the treatment of methylphenidate, with ferritin levels below 30 ng/ml and absence of anemia. They were randomly assigned into two groups of ferrous sulfate and placebo, for 12 weeks. Conners' Parent Rating Scale (CPRS) was used to assess the outcome in the first, sixth, and twelfth weeks.
Results


Almost all CPRS subscales improved in the ferrous sulfate group from the baseline to the endpoint, although only the changes in conduct subscale scores were significant ( p  = 0.003). There was no significant difference in score changes between two groups in intergroup comparison. Also, the score of learning problems ( p  = 0.007) in the first six weeks, and conduct ( p  = 0.023) and psychosomatic ( p  = 0.018) subscales in the second six weeks were improved in the ferrous sulfate group compared with the placebo group.
Conclusion


Our study showed promising effects of iron supplementation in the improvement of subscales of the CPRS.",2021,"Also, the score of learning problems ( p  = 0.007) in the first six weeks, and conduct ( p  = 0.023) and psychosomatic ( p  = 0.018) subscales in the second six weeks were improved in the ferrous sulfate group compared with the placebo group.
","['50 children with attention deficit hyperactivity disorder under the treatment of methylphenidate, with ferritin levels below 30 ng/ml and absence of anemia', 'Children Treated with']","['methylphenidate', 'ferrous sulfate', 'Methylphenidate', 'Iron Supplementation', 'iron supplementation', 'ferrous sulfate and placebo', 'placebo']","['CPRS subscales', 'psychosomatic', 'conduct subscale scores', 'score changes', 'score of learning problems', ""Conners' Parent Rating Scale (CPRS"", 'Attention Deficit Hyperactivity Disorder']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]",50.0,0.287598,"Also, the score of learning problems ( p  = 0.007) in the first six weeks, and conduct ( p  = 0.023) and psychosomatic ( p  = 0.018) subscales in the second six weeks were improved in the ferrous sulfate group compared with the placebo group.
","[{'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Tohidi', 'Affiliation': 'Student Research Committee, School of Medicine, Guilan Universtiy of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Bidabadi', 'Affiliation': 'Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mohammad-Javad', 'Initials': 'MJ', 'LastName': 'Khosousi', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Melika', 'Initials': 'M', 'LastName': 'Amoukhteh', 'Affiliation': 'Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kousha', 'Affiliation': 'Department of Psychiatry, Shafa Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Mashouf', 'Affiliation': 'Emergency Department, Arya Hospital, Rasht, Iran.'}, {'ForeName': 'Tamkin', 'Initials': 'T', 'LastName': 'Shahraki', 'Affiliation': 'Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2021.19.4.712']
2016,34693613,Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial.,"AIMS


Despite aortic stenosis (AS) relief, patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk of developing heart failure (HF) within first months of intervention. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors have been shown to reduce the risk of HF hospitalization in individuals with diabetes mellitus, reduced left ventricular ejection fraction and chronic kidney disease. However, the effect of SGLT-2 inhibitors on outcomes after TAVI is unknown. The Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) trial is designed to assess the clinical benefit and safety of the SGLT-2 inhibitor dapagliflozin in patients undergoing TAVI.
METHODS


DapaTAVI is an independent pragmatic, controlled, prospective, randomized, open-label blinded endpoint, multicentre trial conducted in Spain, evaluating the effect of dapagliflozin 10 mg/day on the risk of death and worsening HF in patients with severe AS undergoing TAVI. Candidate patients should have prior history of HF admission plus ≥1 of the following criteria: (i) diabetes mellitus, (ii) left ventricular ejection fraction ≤40%, or (iii) estimated glomerular filtration rate between 25 and 75 ml/min/1.73 m 2  . A total of 1020 patients will be randomized (1:1) to dapagliflozin vs. no dapagliflozin. Key secondary outcomes include: (i) incidence rate of individual components of the primary outcome; (ii) cardiovascular mortality; (iii) the composite of HF hospitalization or cardiovascular death; and (iv) total number of HF rehospitalizations.
CONCLUSION


DapaTAVI will determine the efficacy and safety of dapagliflozin in a broad spectrum of frail patients after AS relief by TAVI.",2021,"CONCLUSION


DapaTAVI will determine the efficacy and safety of dapagliflozin in a broad spectrum of frail patients after AS relief by TAVI.","['individuals with diabetes mellitus (DM), reduced left ventricular ejection fraction (LVEF) and chronic kidney disease (CKD', 'patients undergoing', 'frail patients after AS relief by TAVI', 'patients undergoing TAVI', '1020 patients', 'patients with severe AS undergoing a TAVI']","['dapagliflozin', 'Sodium-glucose co-transporter 2 (SGLT-2) inhibitors', 'SGLT-2 inhibitor dapagliflozin', 'transcatheter aortic valve implantation (TAVI', 'dapagliflozin versus no dapagliflozin', 'Dapagliflozin', 'SGLT-2 inhibitors', 'Transcatheter Aortic Valve Implantation']","[' (i) Incidence rate of individual components of the primary outcome; (ii) Cardiovascular mortality; (iii', 'composite of HF hospitalization or CV death; (iv) Total number of recurrent HF hospitalizations', 'glomerular filtrate rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0022663', 'cui_str': 'Glomerulus structure'}]",1020.0,0.266485,"CONCLUSION


DapaTAVI will determine the efficacy and safety of dapagliflozin in a broad spectrum of frail patients after AS relief by TAVI.","[{'ForeName': 'Ignacio J', 'Initials': 'IJ', 'LastName': 'Amat-Santos', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Sánchez-Luna', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Abu-Assi', 'Affiliation': 'Department of Cardiology, Hospital Álvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Melendo-Viu', 'Affiliation': 'Department of Cardiology, Hospital Álvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cruz-Gonzalez', 'Affiliation': 'Cardiology Department, Hospital Clínico Universitario, Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Nombela-Franco', 'Affiliation': 'Cardiology Department, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Muñoz-Garcí', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Sergio G', 'Initials': 'SG', 'LastName': 'Blas', 'Affiliation': 'Cardiology Department, Hospital Clínico Universitario, Valencia, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'de la Torre Hernandez', 'Affiliation': 'Cardiology Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romaguera', 'Affiliation': 'Cardiology Department, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Sánchez-Recalde', 'Affiliation': 'Cardiology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Diez-Gil', 'Affiliation': 'Cardiology Department, Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Lopez-Otero', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Gheorge', 'Affiliation': 'Cardiology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibáñez', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez-Romo', 'Affiliation': 'Department of Cardiology, Hospital Álvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Raposeiras-Roubín', 'Affiliation': 'Department of Cardiology, Hospital Álvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.2370']
2017,34693606,Comparative Study of the Effectiveness of Laboratory-Formulated Polishing Pastes for Two CAD/CAM Ceramic Restorative Materials.,"PURPOSE


To evaluate the effect of different polishing pastes with different particle sizes on the surface finish of two different CAD/CAM ceramics.
MATERIALS AND METHODS


A total of 128 specimens were prepared of two CAD/CAM ceramics: lithium disilicate (12.4 × 14.5 × 2 mm) and monolithic zirconia (17.5 × 12.5 × 2.5 mm). They were divided randomly into 8 groups according to surface treatment (n = 8). Group 1 (control) was left as received after crystallization or sintering with no further surface treatment; Group 2 (glazed); Group 3 (positive control), where specimens were polished using standardized surface treatment (medium grit silicon carbide discs, rubber cup and pumice slurry, then rubber cup and toothpaste). For groups 4 to 8, in addition to silicon carbide and pumice slurry polishing, specimens were further polished using a diamond paste (DP), and polishing pastes of microzirconia (MZ), nanosilica (NS), nanodiamond (ND), and nanozirconia (NZ), respectively. Surface roughness (R a  ) was measured using noncontact profilometer. The mean values were compared using ANOVA and Post Hoc Tukey's test (α = 0.05). Specimens' surfaces were studied using a scanning electron microscope (SEM).
RESULTS


Positive control group and MZ exhibited significant R a  of lithium disilicate compared to control (p ˂ 0.001), glazed (p = 0.001), DPs (p = 0.002), NS (p ˂ 0.001), ND (p ˂ 0.001), and NZ (p = 0.002). In the case of zirconia, positive control showed a significantly higher R a  compared to all other groups (p ˂ 0.001). No statistical difference was found between all other polishing techniques (positive control, glazed, DPs, NS, ND, MZ, and NZ) (p > 0.05).
CONCLUSION


Polishing with ND, NZ, and NS lab-formulated pastes produced surfaces with comparable smoothness to control and glazed specimens for lithium disilicate and zirconia ceramic materials.",2021,"Polishing with ND, NZ and NS lab-formulated pastes produced surfaces with comparable smoothness to control and glazed specimens for lithium disilicate and zirconia ceramic materials.","['A total of 128 specimens were prepared of two CAD/CAM ceramics: lithium disilicate (12.4×14.5×2mm) and monolithic zirconia (17.5×12.5×2.5mm', 'Two CAD/CAM Ceramic Restorative Materials']","['crystallization or sintering with no further surface treatment; Group 2 (glazed); Group 3 (positive control), where specimens were polished using standardized surface treatment (medium grit silicon carbide discs, rubber cup and pumice slurry, then rubber cup and toothpaste', 'diamond paste (DP), and polishing pastes of microzirconia (MZ), nanosilica (NS), nanodiamond (ND), and nanozirconia (NZ']","['mean values', 'polishing techniques (positive control, glazed, DPs, NS, ND, MZ and NZ']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}]","[{'cui': 'C0010423', 'cui_str': 'Crystallization'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0440273', 'cui_str': 'Grit'}, {'cui': 'C0074523', 'cui_str': 'Silicon carbide'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0072604', 'cui_str': 'pumice'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C2936467', 'cui_str': 'Nanodiamonds'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936467', 'cui_str': 'Nanodiamonds'}]",128.0,0.0448856,"Polishing with ND, NZ and NS lab-formulated pastes produced surfaces with comparable smoothness to control and glazed specimens for lithium disilicate and zirconia ceramic materials.","[{'ForeName': 'Amr A', 'Initials': 'AA', 'LastName': 'Mahrous', 'Affiliation': 'Department of Substitutive Dental Sciences, College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Passent', 'Initials': 'P', 'LastName': 'Ellakany', 'Affiliation': 'Department of Substitutive Dental Sciences, College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Abualsaud', 'Affiliation': 'Department of Substitutive Dental Sciences, College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Al-Thobity', 'Affiliation': 'Department of Substitutive Dental Sciences, College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Akhtar', 'Affiliation': 'Department of Biophysics, Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Intisar A', 'Initials': 'IA', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Dental Education, College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Gad', 'Affiliation': 'Department of Substitutive Dental Sciences, College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13444']
2018,34694346,Left Ventricular Dysfunction Among Patients With Embolic Stroke of Undetermined Source and the Effect of Rivaroxaban vs Aspirin: A Subgroup Analysis of the NAVIGATE ESUS Randomized Clinical Trial.,"Importance


It is uncertain whether anticoagulation is superior to aspirin at reducing recurrent stroke in patients with recent embolic strokes of undetermined source (ESUS) and left ventricular (LV) dysfunction.
Objective


To determine whether anticoagulation is superior to aspirin in reducing recurrent stroke in patients with ESUS and LV dysfunction.
Design, Setting, and Participants


Post hoc exploratory analysis of data from the New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial vs Aspirin to Prevent Embolism in ESUS (NAVIGATE ESUS) trial, a randomized, phase 3 clinical trial with enrollment from December 2014 to September 2017. The study setting included 459 stroke recruitment centers in 31 countries. Patients 50 years or older who had neuroimaging-confirmed ESUS between 7 days and 6 months before screening were eligible. Of the 7213 NAVIGATE ESUS participants, 7107 (98.5%) had a documented assessment of LV function at study entry and were included in the present analysis. Data were analyzed in January 2021.
Interventions


Participants were randomized to receive either 15 mg of rivaroxaban or 100 mg of aspirin once daily.
Main Outcomes and Measures


The study examined whether rivaroxaban was superior to aspirin at reducing the risk of (1) the trial primary outcome of recurrent stroke or systemic embolism and (2) the trial secondary outcome of recurrent stroke, systemic embolism, myocardial infarction, or cardiovascular mortality during a median follow-up of 10.4 months. LV dysfunction was identified locally through echocardiography and defined as moderate to severe global impairment in LV contractility and/or a regional wall motion abnormality. A Cox proportional hazards model was used to assess for treatment interaction and to estimate the hazard ratios for those randomized to rivaroxaban vs aspirin by LV dysfunction status.
Results


LV dysfunction was present in 502 participants (7.1%). Of participants with LV dysfunction, the mean (SD) age was 67 (10) years, and 130 (26%) were women. Among participants with LV dysfunction, annualized primary event rates were 2.4% (95% CI, 1.1-5.4) in those assigned to rivaroxaban vs 6.5% (95% CI, 4.0-11.0) in those assigned aspirin. Among the 6605 participants without LV dysfunction, rates were similar between those assigned to rivaroxaban (5.3%; 95% CI, 4.5-6.2) vs aspirin (4.5%; 95% CI, 3.8-5.3). Participants with LV dysfunction assigned to rivaroxaban vs aspirin had a lower risk of the primary outcome (hazard ratio, 0.36; 95% CI, 0.14-0.93), unlike those without LV dysfunction (hazard ratio, 1.16; 95% CI, 0.93-1.46) (P for treatment interaction = .03). Results were similar for the secondary outcome.
Conclusions and Relevance


In this post hoc exploratory analysis, rivaroxaban was superior to aspirin in reducing the risk of recurrent stroke or systemic embolism among NAVIGATE ESUS participants with LV dysfunction.
Trial Registration


ClinicalTrials.gov Identifier: NCT02313909.",2021,"In this post hoc exploratory analysis, rivaroxaban was superior to aspirin in reducing the risk of recurrent stroke or systemic embolism among NAVIGATE ESUS participants with LV dysfunction.
","['patients with ESUS and LV dysfunction', 'patients with recent embolic strokes of undetermined source (ESUS) and left ventricular (LV) dysfunction', 'Participants with LV dysfunction assigned to', 'Patients 50 years or older who had neuroimaging-confirmed ESUS between 7 days and 6 months before screening were eligible', '7213 NAVIGATE ESUS participants, 7107 (98.5%) had a documented assessment of LV function at study entry and were included in the present analysis', 'participants with LV dysfunction, the mean (SD) age was 67 (10) years, and 130 (26%) were women', '459 stroke recruitment centers in 31 countries']","['Rivaroxaban vs Aspirin', 'Aspirin', 'rivaroxaban', 'rivaroxaban vs aspirin', 'aspirin']","['annualized primary event rates', 'LV dysfunction', 'recurrent stroke or systemic embolism', 'recurrent stroke', 'risk of recurrent stroke or systemic embolism', 'recurrent stroke, systemic embolism, myocardial infarction, or cardiovascular mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0242973', 'cui_str': 'Ventricular dysfunction'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",6605.0,0.704924,"In this post hoc exploratory analysis, rivaroxaban was superior to aspirin in reducing the risk of recurrent stroke or systemic embolism among NAVIGATE ESUS participants with LV dysfunction.
","[{'ForeName': 'Alexander E', 'Initials': 'AE', 'LastName': 'Merkler', 'Affiliation': 'Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, New York.'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'Biostatistics Consultant, St Catharines, Ontario, Canada.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Department of Medicine (Neurology), McMaster University, Population Health Research Institute, Hamilton, Canada.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Birnbaum', 'Affiliation': 'Department of Neurosurgery, University of Texas Health Sciences Center, San Antonio.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Kamel', 'Affiliation': 'Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, New York.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Department of Neurology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Neurology, Yale University School of Medicine, New Haven, Connecticut.'}]",JAMA neurology,['10.1001/jamaneurol.2021.3828']
2019,34670132,Evaluating the efficacy and moderators of algorithm-guided antidepressant treatments of major depressive disorder.,"BACKGROUND


In spite of numerous options, the most efficacious treatment for major depressive disorder (MDD) remains elusive. Algorithm-guided treatments (AGTs) are proposed to address inadequate remission and optimize treatment delivery. This study aimed to evaluate the clinical benefit of AGTs for MDD, and to explore specific moderators of treatment outcomes for individual patients.
METHODS


The study recruited 987 patients with MDD across eight hospitals who were randomly assigned to AGT with escitalopram (AGT-E), AGT with mirtazapine (AGT-M), or treatment-as-usual (TAU). The outcomes were symptom remission, response rate, early improvement rate, subsymptom clusters improvement over time, the mean time to first remission, relapse rate at 6-months posttreatment follow-up, quality of life (QOL), and adverse events.
RESUTLS


No significant differences were observed across groups in outcome, except that TAU showed significantly poorer QOL, higher relapse rates at 6-months posttreatment follow-up, and marginally significantly worse maximal burden of adverse events than the AGT groups. After 6 weeks of treatment initiation, remission rate did not significantly increase with extended treatment. AGT-M outperformed the TAU and AGT-E in treating sleep symptoms. AGT-E was less effective than AGT-M and TAU in patients with severe depression and somatic symptoms (DSSS). The superiority of TAU over AGTs was observed in recurrent MDD patients.
CONCLUSION


Although the superiority of AGTs over TAU was limited by failure of alternative subsequent treatment, AGTs outperformed in QOL and relapse rate. Types of disease episode and DSSS were regarded as specific moderators in treatment of depression. These findings might contribute to future research on targeted antidepressant treatment.",2021,"Although the superiority of AGTs over TAU was limited by failure of alternative subsequent treatment, AGTs outperformed in QOL and relapse rate.","['major depressive disorder', 'recurrent MDD patients', 'individual patients', '987 patients with MDD across eight hospitals who were randomly assigned to', 'patients with severe depression and somatic symptoms (DSSS']","['algorithm-guided antidepressant treatments', 'Algorithm-guided treatments (AGTs', 'AGT with escitalopram (AGT-E), AGT with mirtazapine (AGT-M), or treatment-as-usual (TAU']","['remission rate', 'maximal burden of adverse events', 'poorer QOL, higher relapse rates', 'symptom remission, response rate, early improvement rate, subsymptom clusters improvement over time, the mean time to first remission, relapse rate at 6-months posttreatment follow-up, quality of life (QOL), and adverse events', 'QOL and relapse rate']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002555', 'cui_str': 'Aminoglutethimide'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",987.0,0.0669085,"Although the superiority of AGTs over TAU was limited by failure of alternative subsequent treatment, AGTs outperformed in QOL and relapse rate.","[{'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Division of Mood Disorders & Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Psychology, Shanghai Deji Hospital, affiliated to Qingdao University, Shanghai 200331, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Division of Mood Disorders & Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China.'}, {'ForeName': 'Yousong', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Division of Mood Disorders & Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Division of Mood Disorders & Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Hong', 'Affiliation': 'Division of Mood Disorders & Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China.'}, {'ForeName': 'Yiyun', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Division of Mood Disorders & Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China.'}, {'ForeName': 'Daihui', 'Initials': 'D', 'LastName': 'Peng', 'Affiliation': 'Division of Mood Disorders & Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China. Electronic address: pdhsh@126.com.'}, {'ForeName': 'Yiru', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Division of Mood Disorders & Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Shanghai 200031, China. Electronic address: yirufang@aliyun.com.'}]",Journal of affective disorders,['10.1016/j.jad.2021.10.011']
2020,34693748,"Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial.","BACKGROUND/AIMS


When participants in individually randomized group treatment trials are treated by multiple clinicians or in multiple group treatment sessions throughout the trial, this induces partially nested clusters which can affect the power of a trial. We investigate this issue in the Whole Health Options and Pain Education trial, a three-arm pragmatic, individually randomized clinical trial. We evaluate whether partial clusters due to multiple visits delivered by different clinicians in the Whole Health Team arm and dynamic participant groups due to changing group leaders and/or participants across treatment sessions during treatment delivery in the Primary Care Group Education arm may impact the power of the trial. We also present a Bayesian approach to estimate the intraclass correlation coefficients.
METHODS


We present statistical models for each treatment arm of Whole Health Options and Pain Education trial in which power is estimated under different intraclass correlation coefficients and mapping matrices between participants and clinicians or treatment sessions. Power calculations are based on pairwise comparisons. In practice, sample size calculations depend on estimates of the intraclass correlation coefficients at the treatment sessions and clinician levels. To accommodate such complexities, we present a Bayesian framework for the estimation of intraclass correlation coefficients under different participant-to-session and participant-to-clinician mapping scenarios. We simulated continuous outcome data based on various clinical scenarios in Whole Health Options and Pain Education trial using a range of intraclass correlation coefficients and mapping matrices and used Gibbs samplers with conjugate priors to obtain posteriors of the intraclass correlation coefficients under those different scenarios. Posterior means and medians and their biases are calculated for the intraclass correlation coefficients to evaluate the operating characteristics of the Bayesian intraclass correlation coefficient estimators.
RESULTS


Power for Whole Health Team versus Primary Care Group Education is sensitive to the intraclass correlation coefficient in the Whole Health Team arm. In these two arms, an increased number of clinicians, more evenly distributed workload of clinicians, or more homogeneous treatment group sizes leads to increased power. Our simulation study for the intraclass correlation coefficient estimation indicates that the posterior mean intraclass correlation coefficient estimator has less bias when the true intraclass correlation coefficients are large (i.e. 0.10), but when the intraclass correlation coefficient is small (i.e. 0.01), the posterior median intraclass correlation coefficient estimator is less biased.
CONCLUSION


Knowledge of intraclass correlation coefficients and the structure of clustering are critical to the design of individually randomized group treatment trials with partially nested clusters. We demonstrate that the intraclass correlation coefficient of the Whole Health Team arm can affect power in the Whole Health Options and Pain Education trial. A Bayesian approach provides a flexible procedure for estimating the intraclass correlation coefficients under complex scenarios. More work is needed to educate the research community about the individually randomized group treatment design and encourage publication of intraclass correlation coefficients to help inform future trial designs.",2021,"RESULTS


Power for Whole Health Team versus Primary Care Group Education is sensitive to the intraclass correlation coefficient in the Whole Health Team arm.",[],[],[],[],[],[],,0.048033,"RESULTS


Power for Whole Health Team versus Primary Care Group Education is sensitive to the intraclass correlation coefficient in the Whole Health Team arm.","[{'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Tong', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Seal', 'Affiliation': 'San Francisco VA Health Care System, Integrative Health Service, San Francisco, CA, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Becker', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Dziura', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Peduzzi', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Esserman', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}]","Clinical trials (London, England)",['10.1177/17407745211051288']
2021,34694644,Initial experience with CytoSorb therapy in patients receiving left ventricular assist devices.,"BACKGROUND


The use of left ventricular assist devices (LVAD) in patients with advance heart failure is still associated with an important risk of immune dysregulation and infections. The aim of this study was to determine whether extracorporeal blood purification using the CytoSorb device benefits patients after LVAD implantation in terms of complications and overall survival.
MATERIALS AND METHODS


Between August 2010 and January 2020, 207 consecutive patients underwent LVAD implantation, of whom 72 underwent CytoSorb therapy and 135 did not. Overall survival, major adverse events, and laboratory parameters were compared between 112 propensity score-matched patients (CytoSorb: 72 patients; non-CytoSorb: 40 patients).
RESULTS


WBC (p = .033), CRP (p = .001), and IL-6 (p < .001), significantly increased with LVAD implantation, while CytoSorb did not influence this response. In-hospital mortality and overall survival during follow-up were similar with CytoSorb. However, patients treated with CytoSorb were more likely to develop respiratory failure (54.2% vs. 30.0%, p = .024), need mechanical ventilation for longer than 6 days post-implant (50.0% vs. 27.5%, p = .035), and require tracheostomy during hospitalization (31.9% vs. 12.5%, p = .040). No other significant differences were observed with regard to major adverse events during follow-up.
CONCLUSIONS


Overall, our results showed that CytoSorb might not convey a significant morbidity or mortality benefit for patients undergoing LVAD implantation.",2021,"RESULTS


WBC (p=0.033), CRP (p=0.001), and IL-6 (p<0.001), significantly increased with LVAD implantation, whileCytoSorb did not influence this response.","['Between August 2010 and January 2020, 207 consecutive patients underwent LVAD implantation, of whom 72 underwent CytoSorb therapy and 135 did not', 'patients undergoing LVAD implantation', 'patients receiving left ventricular assist devices', 'patients with advance heart failure']","['left ventricular assist devices (LVAD', 'LVAD implantation', 'CytoSorb therapy']","['complications and overall survival', 'hospital mortality and overall survival', 'major adverse events', 'CRP (p=0.001), and IL-6', 'Overall survival, major adverse events, and laboratory parameters', 'develop respiratory failure', 'require tracheostomy during hospitalization', 'need mechanical ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",207.0,0.104284,"RESULTS


WBC (p=0.033), CRP (p=0.001), and IL-6 (p<0.001), significantly increased with LVAD implantation, whileCytoSorb did not influence this response.","[{'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Zhigalov', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jef', 'Initials': 'J', 'LastName': 'Van den Eynde', 'Affiliation': 'International Thoracic and Cardiovascular Research Association (ITCVR), Oldenburg, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Zubarevich', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chrosch', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Goerdt', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Arjomandi Rad', 'Affiliation': 'International Thoracic and Cardiovascular Research Association (ITCVR), Oldenburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vardanyan', 'Affiliation': 'International Thoracic and Cardiovascular Research Association (ITCVR), Oldenburg, Germany.'}, {'ForeName': 'Michel Pompeu Barros Oliveira', 'Initials': 'MPBO', 'LastName': 'Sá', 'Affiliation': 'International Thoracic and Cardiovascular Research Association (ITCVR), Oldenburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Luedike', 'Affiliation': 'Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Pizanis', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Schmack', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Kamler', 'Affiliation': 'Department of Cardiothoracic Surgery, Heart Center Essen Huttrop, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Arjang', 'Initials': 'A', 'LastName': 'Ruhparwar', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Weymann', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, Essen, Germany.'}]",Artificial organs,['10.1111/aor.14099']
2022,34673326,Evaluation of the frequency following response as a predictive biomarker of response to cognitive training in schizophrenia.,"Neurophysiological biomarkers of auditory processing show promise predicting outcomes following auditory-based targeted cognitive training (TCT) in schizophrenia, but the viability of the frequency following response (FFR) as a biomarker has yet to be examined, despite its ecological and face validity for auditory-based interventions. FFR is an event-related potential (ERP) that reflects early auditory processing. We predicted that schizophrenia patients would show acute- and longer-term FFR malleability in the context of TCT. Patients were randomized to either TCT (n = 30) or treatment as usual (TAU; n = 22), and electroencephalography was recorded during rapid presentation of an auditory speech stimulus before treatment, after one hour of training, and after 30 h of training. Whereas patients in the TCT group did not show changes in FFR after training, amplitude reductions were observed in the TAU. FFR was positively associated with performance on a measure of single word-in-noise perception in the TCT group, and with a measure of sentence-in-noise perception in both groups. Psychometric reliability analyses of FFR scores indicated high internal consistency but low one-hour and 12-week test-rest reliability. These findings support the dissociation between measures of speech discriminability along the hierarchy of cortical and subcortical early auditory information processing in schizophrenia.",2021,"FFR was positively associated with performance on a measure of single word-in-noise perception in the TCT group, and with a measure of sentence-in-noise perception in both groups.","['schizophrenia', 'schizophrenia patients']","['auditory-based targeted cognitive training (TCT', 'cognitive training', 'TCT']","['FFR malleability', 'FFR', 'amplitude reductions']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.00866135,"FFR was positively associated with performance on a measure of single word-in-noise perception in the TCT group, and with a measure of sentence-in-noise perception in both groups.","[{'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Clayson', 'Affiliation': 'Department of Psychology, University of South Florida, University of California San Diego, 9500 Gilman Drive #0804 La Jolla, Tampa, CA 92093, USA.'}, {'ForeName': 'Juan L', 'Initials': 'JL', 'LastName': 'Molina', 'Affiliation': 'VISN 22 Mental Illness Research, Education and Clinical Center (MIRECC), San Diego VA Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Yash B', 'Initials': 'YB', 'LastName': 'Joshi', 'Affiliation': 'VISN 22 Mental Illness Research, Education and Clinical Center (MIRECC), San Diego VA Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Sprock', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nungaray', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Neal R', 'Initials': 'NR', 'LastName': 'Swerdlow', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Light', 'Affiliation': 'VISN 22 Mental Illness Research, Education and Clinical Center (MIRECC), San Diego VA Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California San Diego, San Diego, CA, USA. Electronic address: glight@ucsd.edu.'}]",Psychiatry research,['10.1016/j.psychres.2021.114239']
2023,34689382,Predictive value of EGFR mutation in non-small-cell lung cancer patients treated with platinum doublet postoperative chemotherapy.,"The mutation status of tumor tissue DNA (n = 389) of resected stage II-III non-squamous non-small-cell lung cancer (Ns-NSCLC) was analyzed using targeted deep sequencing as an exploratory biomarker study (JIPANG-TR) for the JIPANG study, a randomized phase III study of pemetrexed/cisplatin (Pem/Cis) vs vinorelbine/cisplatin (Vnr/Cis). The TP53 mutation, common EGFR mutations (exon 19 deletion and L858R), and KRAS mutations were frequently detected. The frequency of the EGFR mutation was significant among female patients. Patients with an EGFR mutation-positive status had a significantly shorter recurrence-free survival (RFS) time (24 mo vs not reached) (HR, 1.64; 95% CI, 1.22-2.21; P = .0011 for EGFR mutation status). Multivariable analysis identified both the pathological stage and EGFR mutation status as independent prognostic factors for RFS (HR, 1.78; 95% CI, 1.30-2.44; P = .0003 for disease stage; and HR, 1.57; 95% CI, 1.15-2.16; P = .0050 for EGFR mutation status). This study demonstrated that the EGFR mutation has either a poor prognostic or predictive impact on a poor response to postoperative chemotherapy with platinum doublet chemotherapy for stage II-III Ns-NSCLC patients. This result supports a role for mandatory molecular diagnosis of early-stage Ns-NSCLC for precision oncology and signifies the importance of adjuvant for the 3rd generation tyrosine kinase inhibitor rather than platinum-based chemotherapy. This study is registered with the UMIN Clinical Trial Registry (UMIN 000012237).",2021,"The mutation status of tumor tissue DNA (n = 389) of resected stage II-III non-squamous non-small cell lung cancer (Ns-NSCLC) was analyzed using targeted deep sequencing as an exploratory biomarker study (JIPANG-TR) for the JIPANG study, a randomized phase III study of pemetrexed/cisplatin (Pem/Cis) versus vinorelbine/cisplatin (Vnr/Cis).","['NSCLC patients treated with platinum doublet postoperative chemotherapy', 'female patients']","['platinum doublet chemotherapy', 'pemetrexed/cisplatin (Pem/Cis) versus vinorelbine/cisplatin (Vnr/Cis']","['recurrent free survival (RFS', 'frequency of EGFR mutation']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",,0.170234,"The mutation status of tumor tissue DNA (n = 389) of resected stage II-III non-squamous non-small cell lung cancer (Ns-NSCLC) was analyzed using targeted deep sequencing as an exploratory biomarker study (JIPANG-TR) for the JIPANG study, a randomized phase III study of pemetrexed/cisplatin (Pem/Cis) versus vinorelbine/cisplatin (Vnr/Cis).","[{'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Japan.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Sakai', 'Affiliation': 'Department of Genome Biology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Kenmotsu', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Yoh', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Daga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Ohira', 'Affiliation': 'Department of Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Department of Thoracic Surgery, National Hospital Organization, Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Aoki', 'Affiliation': 'Department of Chest Surgery, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Thoracic Surgery, Clinical Research Institute, National Hospital Organization, Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Hosomi', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Toyofumi F', 'Initials': 'TF', 'LastName': 'Chen-Yoshikawa', 'Affiliation': 'Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Okumura', 'Affiliation': 'Department of Thoracic Surgery, Kurashiki Central Hospital, Kurashiki, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Medical Oncology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Akimasa', 'Initials': 'A', 'LastName': 'Sekine', 'Affiliation': 'Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Haruki', 'Affiliation': 'Division of General Thoracic Surgery, Department of Surgery, Faculty of Medicine, Tottori University, Tottori, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Thoracic Surgery, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Akamatsu', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Saeki', 'Affiliation': 'Department of Respiratory Medicine, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sugio', 'Affiliation': 'Department of Thoracic and Breast Surgery, Oita University, Oita, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation For Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Inokawa', 'Affiliation': 'Division of Thoracic Surgery, Yamaguchi Ube Medical Center, Ube, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Nishio', 'Affiliation': 'Department of Genome Biology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}]",Cancer science,['10.1111/cas.15171']
2024,34689304,"The Contribution of Galenics to Patients' Sensory Perception of Nasal Sprays After Nasal Surgery: Data from a Prospective Randomised, Controlled, Double-Blind, Crossover, Multicentre Study.","INTRODUCTION


Postoperative care after nasal surgery is commonly achieved with nasal sprays. The current study compared two decongesting, wound-healing nasal sprays in patients after nasal surgery in order to investigate their sensory perception. One of the sprays was a new galenic formulation (nasic ®  neo, Cassella-med GmbH & Co. KG).
METHODS


According to the crossover design, patients who had undergone nasal surgery applied two different nasal sprays during two treatment periods of 4 days each, interrupted by a 3-day washout period. Sensory perception of the nasal sprays was assessed with the nasal spray sensoric scale. Throughout the study, nasal obstruction was evaluated by patients, and physical examinations, measurements of vital parameters and rhinoscopic examinations were carried out by investigators. Adverse events were documented during the entire study, and following treatment, patients judged the overall preference, efficacy and tolerability of both products.
RESULTS


Overall, no significant differences in sum scores of the assessments of the nasal spray sensoric scale were observed between treatments. A significant period effect observed during the crossover study limited the overall analysis. Nevertheless, significantly more patients preferred the new galenics nasal spray compared to the comparator spray (57.1% vs. 34.7%; p = 0.031). Further, 10% more patients rated the efficacy of the new galenics as 'good' to 'very good' compared to the comparator. Importantly, a subgroup population of patients with more pronounced signs of inflammation present at screening evaluated the sensory perception of the new galenics as significantly better (p = 0.033) compared to the comparator. Within this subgroup, no period effect was observed. The application of both nasal sprays was shown to be safe and well-tolerated.
CONCLUSION


The overall sensory perception of both nasal sprays was evaluated comparably well in patients after nasal surgery and overall the application of the new galenics nasal spray was preferred by significantly more patients compared to the comparator nasal spray. Patients with marked nasal abnormalities may have a greater benefit from the contribution of galenics as significant differences in the sensory evaluation by the nasal spray sensoric scale in favour of the new galenics product were shown for this subgroup.
TRIAL REGISTRATION


The current study was registered in the EU Clinical Trials Register with the EudraCT No. 2019-004936-52.",2021,The overall sensory perception of both nasal sprays was evaluated comparably well in patients after nasal surgery and overall the application of the new galenics nasal spray was preferred by significantly more patients compared to the comparator nasal spray.,"['patients after nasal surgery in order to investigate their sensory perception', 'patients who had undergone nasal surgery', 'Patients with marked nasal abnormalities']","['galenic formulation (nasic ®  neo, Cassella-med GmbH & Co', 'Nasal Sprays', 'wound-healing nasal sprays']","['overall sensory perception of both nasal sprays', 'Adverse events', 'safe and well-tolerated', 'overall preference, efficacy and tolerability', 'sensory perception', 'nasal spray sensoric scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0265736', 'cui_str': 'Congenital anomaly of nose'}]","[{'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0266009,The overall sensory perception of both nasal sprays was evaluated comparably well in patients after nasal surgery and overall the application of the new galenics nasal spray was preferred by significantly more patients compared to the comparator nasal spray.,"[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bergmann', 'Affiliation': 'Medical Faculty, University of Essen, 45147, Essen, Germany.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lander', 'Affiliation': 'Faculty of Medicine, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Radtke', 'Affiliation': 'ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'England', 'Affiliation': 'ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany.'}, {'ForeName': 'Jaswinder', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Mösges', 'Affiliation': 'ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany. ralph@moesges.de.'}]",Advances in therapy,['10.1007/s12325-021-01937-x']
2025,34678677,"Crossover and rechallenge with pembrolizumab in recurrent patients from the EORTC 1325-MG/Keynote-054 phase III trial, pembrolizumab versus placebo after complete resection of high-risk stage III melanoma.","BACKGROUND


In the phase III double-blind European Organisation for Research and Treatment of Cancer 1325/KEYNOTE-054 trial, pembrolizumab improved recurrence-free and distant metastasis-free survival in patients with stage III cutaneous melanoma with complete resection of lymph nodes. In the pembrolizumab group, the incidence of grade I-V and of grade III-V immune-related adverse events (irAEs) was 37% and 7%, respectively.
METHODS


Patients were randomised to receive intravenous (i.v.) pembrolizumab 200 mg (N = 514) or placebo (N = 505) every 3 weeks, up to 1 year. On recurrence, patients could enter part 2 of the study: pembrolizumab 200 mg i.v. every 3 weeks up to 2 years, for crossover (those who received placebo) or rechallenge (those who had recurrence ≥6 months after completing 1-year adjuvant pembrolizumab therapy). For these patients, we present the safety profile and efficacy outcomes.
RESULTS


At the clinical cut-off (16-Oct-2020), in the placebo group, 298 patients had a disease recurrence, in which 155 (52%) crossed over ('crossover'). In the pembrolizumab group, 297 patients completed the 1-year treatment period; 47 had a recurrence ≥6 months later, in which 20 (43%) entered the rechallenge part 2 ('rechallenge'). In the crossover group, the median progression-free survival (PFS) was 8.5 months (95% confidence interval [CI] 5.7-15.2) and the 3-year PFS rate was 32% (95% CI 25-40%). Among 80 patients with stage IV evaluable disease, 31 (39%) had an objective response: 14 (18%) patients with complete response (CR) and 17 (21%) patients with partial response. The 2-year PFS rate from response was 69% (95% CI 48-83%). In the rechallenge group, the median PFS was 4.1 months (95% CI 2.6-NE). Among 9 patients with stage IV evaluable disease, 1 had an objective response (CR). Among the 175 patients, 51 (29%) had a grade I-IV irAE and 11 (6%) had a grade III-IV irAE.
CONCLUSIONS


Pembrolizumab treatment after crossover yielded an overall 3-year PFS rate of 32% and a 39% ORR in evaluable patients, but the efficacy (11% ORR) was lower in those rechallenged.",2021,"In the crossover group, the median progression-free survival (PFS) was 8.5 months (95% confidence interval [CI] 5.7-15.2) and the 3-year PFS rate was 32% (95% CI 25-40%).","['patients with stage III cutaneous melanoma with complete resection of lymph nodes', '80 patients with stage IV evaluable disease, 31 (39%) had an objective response: 14 (18%) patients with complete response (CR) and 17 (21%) patients with partial response', 'Patients', '175 patients, 51 (29%) had a grade I-IV irAE and 11 (6%) had a grade III-IV irAE', ""297 patients completed the 1-year treatment period; 47 had a recurrence ≥6 months later, in which 20 (43%) entered the rechallenge part 2 ('rechallenge""]","['pembrolizumab versus placebo', 'placebo', 'pembrolizumab']","['median progression-free survival (PFS', '2-year PFS rate', 'disease recurrence', 'safety profile and efficacy outcomes', '3-year PFS rate', 'objective response (CR', 'median PFS', 'incidence of grade I-V and of grade III-V immune-related adverse events (irAEs', 'overall 3-year PFS rate', 'recurrence-free and distant metastasis-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",80.0,0.433176,"In the crossover group, the median progression-free survival (PFS) was 8.5 months (95% confidence interval [CI] 5.7-15.2) and the 3-year PFS rate was 32% (95% CI 25-40%).","[{'ForeName': 'Alexander Mm', 'Initials': 'AM', 'LastName': 'Eggermont', 'Affiliation': 'Princess Máxima Center and University Medical Center Utrecht, Utrecht, 3584 CS, the Netherlands. Electronic address: alexander.eggermont@prinsesmaximacentrum.nl.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Meshcheryakov', 'Affiliation': 'Federal State Budgetary Institution ""Russian Oncology Scientific Centre named after N.N. Blokhin RAMS"", Moscow, Russia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute - Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandala', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy; Ospedale Santa Maria Della Misericordia, Perrugia, Italy.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, Australia; Mater and Royal North Shore Hospitals, Sydney, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Barrow', 'Affiliation': 'Wellington Hospital, Wellington, New Zealand.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, University of Siena, Siena, Italy.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Fisher', 'Affiliation': 'North Shore Hospital, Waitemata DHB, Takapuna, Auckland, New Zealand; Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter Maccallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Ragini', 'Initials': 'R', 'LastName': 'Kudchadkar', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Pablo Luis', 'Initials': 'PL', 'LastName': 'Ortiz Romero', 'Affiliation': 'Hospital 12 de Octubre, Institute i+12, CIBERONC, Medical School, University Complutense, Madrid, Spain.'}, {'ForeName': 'Inge Marie', 'Initials': 'IM', 'LastName': 'Svane', 'Affiliation': 'Herlev Hospital, University Copenhagen, Herlev, Denmark.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital - Chelsea, London, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'Hospital Clinic Universitari de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hersey', 'Affiliation': 'David Maddison Clinical Sciences, Gateshead, Australia.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Quaglino', 'Affiliation': 'Azienda Ospedaliera Città della Salute e della Scienza di Torino, Ospedale San Lazzaro, Torino, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Queirolo', 'Affiliation': 'Istituto Nazionale Per La Ricerca Sul Cancro, Genova, Italy; European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Daniil', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Municipal Oncology Hospital 62, Krasnogorskiy, Russia.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'Elbe Kliniken, Buxtehude, Germany.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Hernberg', 'Affiliation': 'Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Azienda Ospedaliera Di Padova, Padova, Italy.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Strother', 'Affiliation': 'Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Universitaetsklinikum Schleswig-Holstein, Campus Kiel - Klinik Dermatologie, Venerologie und Allergologie, Kiel, Germany.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'National Cancer Center Hospital, Chuo-ku, Japan.'}, {'ForeName': 'Alexander Cj', 'Initials': 'AC', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute - Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lorigan', 'Affiliation': 'The University of Manchester and Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Krepler', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy Cancer Campus Grand Paris and University Paris-Saclay, Villejuif, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.09.023']
2026,34680131,Assessment of the Response Profile to Hyaluronic Acid Plus Sorbitol Injection in Patients with Knee Osteoarthritis: Post-Hoc Analysis of a 6-Month Randomized Controlled Trial.,"In a previous randomized trial, the non-inferiority of two hyaluronic acid injections (Synolis VA versus Synvisc-One) was assessed in patients with knee OA, with a response rate of 79% for Synolis VA. To assess whether a responder profile could be established for this treatment modality, we used the Synolis VA arm of a published 6-month prospective, multicenter, comparative, randomized, double-blinded trial. At baseline and during the study, pain and function were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire. Ninety-six subjects from the intention-to-treat trial were included in the analysis. The 6-month change of WOMAC Pain with Synolis VA was not associated with any baseline clinical data. However, the change in WOMAC Function was significantly associated with its baseline level, even after adjustment for potential confounding variables ( p  = 0.028), i.e., a poorer physical function at baseline was associated with a better response. In conclusion, in addition to the high absolute response rate to Synolis VA, the probability of success is even increased if administered in patients with more limited physical function at baseline. Further research with other potential confounding clinical variables is warranted in order to better applicate the concept of personalized medicine.",2021,"However, the change in WOMAC Function was significantly associated with its baseline level, even after adjustment for potential confounding variables ( p  = 0.028), i.e., a poorer physical function at baseline was associated with a better response.","['patients with knee OA', 'Patients with Knee Osteoarthritis', 'Ninety-six subjects from the intention-to-treat trial were included in the analysis']","['hyaluronic acid injections (Synolis VA versus Synvisc-One', 'Hyaluronic Acid Plus Sorbitol Injection']","['poorer physical function', 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire', 'WOMAC Function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0723570', 'cui_str': 'Synvisc'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037688', 'cui_str': 'Sorbitol'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",96.0,0.394717,"However, the change in WOMAC Function was significantly associated with its baseline level, even after adjustment for potential confounding variables ( p  = 0.028), i.e., a poorer physical function at baseline was associated with a better response.","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'WHO Collaborating Centre for Public Health Aspects of Musculo-Skeletal Health and Ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Germain', 'Initials': 'G', 'LastName': 'Honvo', 'Affiliation': 'WHO Collaborating Centre for Public Health Aspects of Musculo-Skeletal Health and Ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vidovic', 'Affiliation': 'Aptissen SA Medical Department, 1228 Plan-les-Ouates, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Cortet', 'Affiliation': 'Department of Rheumatology and UR 4490, University Hospital of Lille, 59000 Lille, France.'}]",Biomolecules,['10.3390/biom11101498']
2027,34699852,Predictive value of cardiometabolic biomarkers and depressive symptoms for symptom severity and quality of life in patients with psychotic disorders.,"BACKGROUND


Patients with psychotic disorders show higher rates of the metabolic syndrome (MS) between the cluster of severe mental illnesses. Depressive symptoms can worsen outcomes of individuals with psychotic disorders. However, research on the association between MS and depression in psychotic disorders and their relevance to outcomes is lacking.
METHODS


We investigated the association between depression and cardiometabolic biomarkers in psychotic disorders and the predictive value of depressive symptoms on psychopathological severity and quality of life (QoL). 406 patients with psychotic disorders were recruited as part of the Improving Physical Health and Reducing Substance Use in Severe Mental Illness randomised controlled trial. Depression, psychotic symptoms, QoL, waist circumference, triglycerides, high-density lipoprotein cholesterol (HDL-C), blood pressure, and fasting glucose of patients were assessed at baseline and 12 months. Sensitivity analyses were conducted to test the effect of treatment.
RESULTS


More severe baseline symptoms of depression significantly predicted worse 12-month psychotic symptoms and lower mental health related QoL at 12 months. These associations held after controlling for alcohol use, gender, ethnicity, education, and mental health related QoL Baseline. Depressive symptoms also correlated with waist circumference at both baseline and 12 months, after controlling for multiple testing.
CONCLUSION


Individuals with psychotic disorders experiencing more severe depressive symptoms are more likely to have larger waist circumference contemporaneously and 12 months later, as well as more severe psychotic symptoms and worse QoL at follow-up. This highlights the need for evaluation of strategies to address depression in the management of psychotic disorders.",2021,More severe baseline symptoms of depression significantly predicted worse 12-month psychotic symptoms and lower mental health related QoL at 12 months.,"['patients with psychotic disorders', 'Patients with psychotic disorders', '406 patients\xa0with\xa0psychotic disorders', 'individuals with psychotic disorders', 'Individuals with psychotic disorders experiencing more severe depressive symptoms']",[],"['Depression, psychotic symptoms, QoL, waist circumference, triglycerides, high-density lipoprotein cholesterol (HDL-C), blood pressure, and fasting glucose', 'Depressive symptoms', '12-month psychotic symptoms and lower mental health related QoL', 'psychopathological severity and quality of life (QoL', 'severe psychotic symptoms and worse QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",[],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",,0.0638038,More severe baseline symptoms of depression significantly predicted worse 12-month psychotic symptoms and lower mental health related QoL at 12 months.,"[{'ForeName': 'C S D H', 'Initials': 'CSDH', 'LastName': 'Perez', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ciufolini', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Poonam Gardner', 'Initials': 'PG', 'LastName': 'Sood', 'Affiliation': 'Clinical Trials Manager, University College London, United Kingdom.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Krivoy', 'Affiliation': 'Sackler Faculty of Medicine, Tel-Aviv University, Ramat-Aviv, Israel.'}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Murray', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Professor of Psychiatry and Medicine, Dept of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill, London, United Kingdom.""}, {'ForeName': 'Zerrin', 'Initials': 'Z', 'LastName': 'Atakan', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings' College London, Denmark Hill, London, United Kingdom.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Greenwood', 'Affiliation': 'Clinical Research Fellow, Sussex Partnership NHS Foundation Trust, and Hon Senior Research Fellow, School of Psychology, University of Sussex.'}, {'ForeName': 'Shubulade', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': ""Clinical Senior Lecturer, Department of Forensic and Neurodevelopmental Science, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill, London.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Gaughran', 'Affiliation': ""Lead Consultant Psychiatrist, National Psychosis Service, South London and Maudsley NHS Foundation Trust and Professor, Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill, London, United Kingdom.""}, {'ForeName': 'Mario F', 'Initials': 'MF', 'LastName': 'Juruena', 'Affiliation': ""Lead Consultant Psychiatrist, Maudsley Advanced Treatment Service, South London and Maudsley NHS Foundation Trust and Clinical Senior Lecturer in Translational Psychiatry, Department of Psychological Medicine, Centre for Affective Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom. Electronic address: Mario.Juruena@kcl.ac.uk.""}]",Journal of affective disorders,['10.1016/j.jad.2021.10.038']
2028,34697008,Ureteral access sheath-related injuries vs. post-operative infections. Is sheath insertion always needed? A prospective randomized study to understand the lights and shadows of this practice.,"OBJECTIVE


To compare intraoperative ureteral injuries in RIRS with UAS insertion with the rate of postoperative infections after RIRS without UAS insertion.
PATIENTS AND METHODS


In this randomized trial, patients who received an indication for RIRS between January 2017 and December 2017 were divided into two groups. Group A had no UAS insertion and Group B had UAS insertion. Post-Ureteroscopic Lesion Scale (PULS) grading was performed after UAS or flexible ureteroscope removal. Proximal, middle and distal ureteral lesions were evaluated and compared according to the PULS scale. Additionally, patients in both groups were followed postoperatively to assess any infective complication.
RESULTS


The evaluation comprised 181 patients, 89 for group A and 92 for group B. Overall stone-free rate, clinically insignificant residual fragments, and final stone-free rate were 41.4%, 53.5%, and 95%, respectively. There were 33 (37.1%) patients with ureteral lesions in group A while 42 (45.6%) patients had ureteral lesions in group B, with no significant difference. On the other hand, the overall presence of postoperative infection rate was much higher for Group A (37.1% vs 16.3% P = 0.03).
CONCLUSIONS


UAS insertion does not result in a higher number of ureteral injuries. UAS insertion during RIRS allows a lower rate of postoperative infections.
CLINICAL TRIAL REGISTRATION NUMBER (ISRCTN REGISTRY NUMBER)


55546280.",2021,"The evaluation comprised 181 patients, 89 for group A and 92 for group B. Overall stone-free rate, clinically insignificant residual fragments, and final stone-free rate were 41.4%, 53.5%, and 95%, respectively.",['patients who received an indication for RIRS between January 2017 and December 2017'],[],"['UAS insertion', 'Proximal, middle and distal ureteral lesions', 'Overall stone-free rate, clinically insignificant residual fragments, and final stone-free rate', 'infective complication', 'ureteral injuries', 'ureteral lesions', 'postoperative infection rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]",[],"[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0238493', 'cui_str': 'Injury of ureter'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}]",,0.0650008,"The evaluation comprised 181 patients, 89 for group A and 92 for group B. Overall stone-free rate, clinically insignificant residual fragments, and final stone-free rate were 41.4%, 53.5%, and 95%, respectively.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bozzini', 'Affiliation': 'ESUT, European Section for UroTechnology EAU, Arnhem, The Netherlands; Urology Department, ASST Valle Olona, Busto Arsizio, Lombardía, Italy. Electronic address: gioboz@yahoo.it.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bevilacqua', 'Affiliation': 'Urology Department, Baggiovara Hospital, Módena, Italy.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Besana', 'Affiliation': 'Urology Department, ASST Valle Olona, Busto Arsizio, Lombardía, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Calori', 'Affiliation': 'Urology Department, ASST Valle Olona, Busto Arsizio, Lombardía, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pastore', 'Affiliation': 'Urology Department, Università La Sapienza, Latina, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Romero Otero', 'Affiliation': 'Urology Department, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Macchi', 'Affiliation': 'Urology Department, INT, Milán, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Broggini', 'Affiliation': 'Urology Department, ASST Valle Olona, Busto Arsizio, Lombardía, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Breda', 'Affiliation': 'ESUT, European Section for UroTechnology EAU, Arnhem, The Netherlands; Urology Department, Fundacio Puigvert, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gozen', 'Affiliation': 'ESUT, European Section for UroTechnology EAU, Arnhem, The Netherlands; Urology Department, University of Heidelberg, Heilbronn, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Inzillo', 'Affiliation': 'Urology Department, Baggiovara Hospital, Módena, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Puliatti', 'Affiliation': 'Urology Department, Baggiovara Hospital, Módena, Italy.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Sighinolfi', 'Affiliation': 'Urology Department, Baggiovara Hospital, Módena, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Rocco', 'Affiliation': 'ESUT, European Section for UroTechnology EAU, Arnhem, The Netherlands; Urology Department, Baggiovara Hospital, Módena, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Liatsikos', 'Affiliation': 'ESUT, European Section for UroTechnology EAU, Arnhem, The Netherlands; Urology Department, University of Patras, Patras, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Muller', 'Affiliation': 'Urology Department, Limattal Hospital, Schilieren, Switzerland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Buizza', 'Affiliation': 'Urology Department, ASST Valle Olona, Busto Arsizio, Lombardía, Italy.'}]",Actas urologicas espanolas,['10.1016/j.acuroe.2020.11.010']
2029,34684474,"Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study.","Scalable, effective interventions are needed to address poor diet, insufficient physical activity, and obesity amongst rising numbers of cancer survivors. Interventions targeting survivors and their friends and family may promote both tertiary and primary prevention. The design, rationale, and enrollment of an ongoing randomized controlled trial (RCT) (NCT04132219) to test a web-based lifestyle intervention for cancer survivors and their supportive partners are described, along with the characteristics of the sample recruited. This two-arm, single-blinded RCT randomly assigns 56 dyads (cancer survivor and partner, both with obesity, poor diets, and physical inactivity) to the six-month DUET intervention vs. wait-list control. Intervention delivery and assessment are remotely performed with 0-6 month, between-arm tests comparing body weight status (primary outcome), and secondary outcomes (waist circumference, health indices, and biomarkers of glucose homeostasis, lipid regulation and inflammation). Despite COVID-19, targeted accrual was achieved within 9 months. Not having Internet access was a rare exclusion (<2%). Inability to identify a support partner precluded enrollment of 42% of interested/eligible survivors. The enrolled sample is diverse: ages 23-81 and 38% racial/ethnic minorities. Results support the accessibility and appeal of web-based lifestyle interventions for cancer survivors, though some cancer survivors struggled to enlist support partners and may require alternative strategies.",2021,"Results support the accessibility and appeal of web-based lifestyle interventions for cancer survivors, though some cancer survivors struggled to enlist support partners and may require alternative strategies.","['cancer survivors and their supportive partners', 'enrolled sample is diverse: ages 23-81 and 38% racial/ethnic minorities', 'Cancer Survivors and Partners']","['Weight Loss Intervention', 'DUET intervention vs. wait-list control', 'web-based lifestyle intervention']","['secondary outcomes (waist circumference, health indices, and biomarkers of glucose homeostasis, lipid regulation and inflammation']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0927446,"Results support the accessibility and appeal of web-based lifestyle interventions for cancer survivors, though some cancer survivors struggled to enlist support partners and may require alternative strategies.","[{'ForeName': 'Dorothy W', 'Initials': 'DW', 'LastName': 'Pekmezi', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham (UAB), Birmingham, AL 35294, USA.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Crane', 'Affiliation': 'Sylvester Comprehensive Cancer Center, Miami, FL 33136, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Oster', 'Affiliation': ""O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham (UAB), Birmingham, AL 35294, USA.""}, {'ForeName': 'Laura Q', 'Initials': 'LQ', 'LastName': 'Rogers', 'Affiliation': ""O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham (UAB), Birmingham, AL 35294, USA.""}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Hoenemeyer', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB), Birmingham, AL 35294, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'People Designs, Inc., Durham, NC 27705, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Cole', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB), Birmingham, AL 35294, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wolin', 'Affiliation': 'Coeus Health, LLC, Chicago, IL 60614, USA.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Badr', 'Affiliation': 'Department of Medicine, Epidemiology and Population Sciences, Baylor College of Medicine, Houston, TX 77030, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': ""O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham (UAB), Birmingham, AL 35294, USA.""}]",Nutrients,['10.3390/nu13103472']
2030,34695841,Effect of Elective Internal Mammary Node Irradiation on Disease-Free Survival in Women With Node-Positive Breast Cancer: A Randomized Phase 3 Clinical Trial.,"Importance


The benefit of internal mammary node irradiation (IMNI) for treatment outcomes in node-positive breast cancer is unknown.
Objective


To investigate whether the inclusion of IMNI in regional nodal irradiation improves disease-free survival (DFS) in women with node-positive breast cancer.
Design, Setting, and Participants


This multicenter, phase 3 randomized clinical trial was conducted from June 1, 2008, to February 29, 2020, at 13 hospitals in South Korea. Women with pathologically confirmed, node-positive breast cancer after breast-conservation surgery or mastectomy with axillary lymph node dissection were eligible and enrolled between November 19, 2008, and January 14, 2013. Patients with distant metastasis and those who had received neoadjuvant treatment were excluded. Data analyses were performed according to the intention-to-treat principle.
Interventions


All patients underwent regional nodal irradiation along with breast or chest wall irradiation. They were randomized 1:1 to receive radiotherapy either with IMNI or without IMNI.
Main Outcomes and Measures


The primary end point was the 7-year DFS. Secondary end points included the rates of overall survival, breast cancer-specific survival, and toxic effects.
Results


A total of 735 women (mean [SD] age, 49.0 [9.1] years) were included in the analyses, of whom 373 received regional nodal irradiation without IMNI and 362 received regional nodal irradiation with IMNI. Nearly all patients underwent taxane-based adjuvant systemic treatment. The median (IQR) follow-up was 100.4 (89.7-112.1) months. The 7-year DFS rates did not significantly differ between the groups treated without IMNI and with IMNI (81.9% vs 85.3%; hazard ratio [HR], 0.80; 95% CI, 0.57-1.14; log-rank P = .22). However, an ad hoc subgroup analysis showed significantly higher DFS rates with IMNI among patients with mediocentrally located tumors. In this subgroup, the 7-year DFS rates were 81.6% without IMNI vs 91.8% with IMNI (HR, 0.42; 95% CI, 0.22-0.82; log-rank P = .008), and the 7-year breast cancer mortality rates were 10.2% without IMNI vs 4.9% with IMNI (HR, 0.41; 95% CI, 0.17-0.99; log-rank P = .04). No differences were found between the 2 groups in the incidence of adverse effects, including cardiac toxic effects and radiation pneumonitis.
Conclusions and Relevance


This randomized clinical trial found that including IMNI in regional nodal irradiation did not significantly improve the DFS in patients with node-positive breast cancer. However, patients with medially or centrally located tumors may benefit from the use of IMNI.
Trial Registration


ClinicalTrials.gov Identifier: NCT04803266.",2021,"No differences were found between the 2 groups in the incidence of adverse effects, including cardiac toxic effects and radiation pneumonitis.
","['Women With Node-Positive Breast Cancer', 'June 1, 2008, to February 29, 2020, at 13 hospitals in South Korea', 'Women with pathologically confirmed, node-positive breast cancer after breast-conservation surgery or mastectomy with axillary lymph node dissection were eligible and enrolled between November 19, 2008, and January 14, 2013', 'Patients with distant metastasis and those who had received neoadjuvant treatment were excluded', '735 women (mean [SD] age, 49.0 [9.1] years) were included in the analyses, of whom 373 received', 'node-positive breast cancer', 'patients with node-positive breast cancer', 'women with node-positive breast cancer']","['taxane-based adjuvant systemic treatment', 'Elective Internal Mammary Node Irradiation', 'regional nodal irradiation without IMNI and 362 received regional nodal irradiation with IMNI', 'radiotherapy either with IMNI or without IMNI', 'internal mammary node irradiation (IMNI', 'regional nodal irradiation along with breast or chest wall irradiation', 'IMNI']","['7-year DFS', 'DFS rates', 'Disease-Free Survival', 'adverse effects, including cardiac toxic effects and radiation pneumonitis', '7-year breast cancer mortality rates', 'disease-free survival (DFS', 'rates of overall survival, breast cancer-specific survival, and toxic effects', '7-year DFS rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0447180', 'cui_str': 'Internal mammary node'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0206063', 'cui_str': 'Radiation pneumonitis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",735.0,0.539171,"No differences were found between the 2 groups in the incidence of adverse effects, including cardiac toxic effects and radiation pneumonitis.
","[{'ForeName': 'Yong Bae', 'Initials': 'YB', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hwa Kyung', 'Initials': 'HK', 'LastName': 'Byun', 'Affiliation': 'Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dae Yong', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Proton Therapy Center, Research Institute and Hospital, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Sung-Ja', 'Initials': 'SJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Radiation Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea.'}, {'ForeName': 'Hyung-Sik', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Su Ssan', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Kyu Chan', 'Initials': 'KC', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Ik Jae', 'Initials': 'IJ', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Taek', 'Initials': 'WT', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Hyun Soo', 'Initials': 'HS', 'LastName': 'Shin', 'Affiliation': 'Department of Radiation Oncology, Bundang CHA Medical Center, CHA University, Gyeonggi-do, Korea.'}, {'ForeName': 'Kyubo', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Ewha Womans University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung Hwan', 'Initials': 'KH', 'LastName': 'Shin', 'Affiliation': 'Department of Radiation Oncology, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chung Mo', 'Initials': 'CM', 'LastName': 'Nam', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chang-Ok', 'Initials': 'CO', 'LastName': 'Suh', 'Affiliation': 'Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}]",JAMA oncology,['10.1001/jamaoncol.2021.6036']
2031,34694869,Effect of Capsaicin Atomization-Induced Cough on Sputum Excretion in Tracheotomized Patients After Hemorrhagic Stroke: A Randomized Controlled Trial.,"Background Timely and effective removal of respiratory secretions is of great significance for tracheotomized patients. The purpose of this study is to investigate the effectiveness of capsaicin nebulization to stimulate cough to promote early clearance of respiratory secretions in tracheotomized patients after hemorrhagic stroke. Method This study implemented a randomized controlled design. Sixty-three patients who were tracheotomized following a hemorrhagic stroke completed this randomized controlled trial. In the control group, 33 cases were given a routine care after tracheotomy. In the intervention group, 30 cases were given a capsaicin solution nebulization in addition to the routine care. The daily sputum output and the number of sputum suctioning were observed. The differences in sputum viscosity, cough function, and Clinical Pulmonary Infection Score (CPIS) were compared between the two groups before and after the intervention. Vital sign changes during capsaicin nebulization and suctioning were compared between the two groups in a pilot study. Results The daily sputum output of the capsaicin intervention group was significantly higher than that of the control group ( p  < .05). The number of sputum suctioning of capsaicin group was less than that of the control group after intervention ( p  < .05). The CPIS score of the capsaicin group was lower than that of the control group ( p  < .05) after a 1-week intervention. Patients' heart rate, respiratory rate, and oxygen saturation during capsaicin nebulization were not statistically different from those during routine sputum suctioning ( p  > .05). Conclusions Capsaicin atomization-induced cough can effectively promote sputum excretion of hemorrhagic stroke patients undergoing tracheotomy and has a good safety profile. The Clinical Trial registration number of this study is ChiCTR2000037772 (http://www.chictr.org.cns). Supplemental Material https://doi.org/10.23641/asha.16821352.",2021,The CPIS score of the capsaicin group was lower than that of the control group ( p  < .05) after a 1-week intervention.,"['After Hemorrhagic Stroke', 'tracheotomized patients', 'hemorrhagic stroke patients undergoing tracheotomy', 'Tracheotomized Patients', 'Sixty-three patients who were tracheotomized following a hemorrhagic stroke', 'tracheotomized patients after hemorrhagic stroke']","['capsaicin solution nebulization', 'Supplemental Material https://doi.org/10.23641/asha.16821352', 'capsaicin intervention', 'Capsaicin Atomization-Induced Cough', 'capsaicin nebulization', 'capsaicin', 'capsaicin nebulization and suctioning']","['number of sputum suctioning', 'sputum viscosity, cough function, and Clinical Pulmonary Infection Score (CPIS', 'Sputum Excretion', 'heart rate, respiratory rate, and oxygen saturation during capsaicin nebulization', 'daily sputum output', 'CPIS score', 'daily sputum output and the number of sputum suctioning']","[{'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]",63.0,0.0275049,The CPIS score of the capsaicin group was lower than that of the control group ( p  < .05) after a 1-week intervention.,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yijie', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Meifen', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': 'Nursing Department, Dushu Lake Affiliated Hospital of Soochow University, Suzhou, China.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2021_JSLHR-21-00151']
2032,34699954,Bioactive self-etching sealant on newly erupted molars: A split-mouth clinical trial.,"OBJECTIVES


This randomized clinical trial compares retention, survival rate, and evolution of caries of newly erupted permanent molars sealed with bioactive self-etching sealants with pre-reacted glass ionomer (S-PRG).
METHODS


A split-mouth clinical trial was conducted with 56 permanent second molars in stages 2 and 3 of crown eruption; ICDAS (International Caries Detection and Assessment System) was between 0 and 2. The molars were randomized and blinded in relation to the side (right or left) that would receive the sealants; the conventional resin sealant (FS), Fluroshield (Dentsply), or bioactive self-etch sealant (BS), BeautiSealant with S-PRG (Shofu). The sealants were compared in terms of retention, quality of sealant remnant (anatomical shape, marginal adaptation, surface texture, and marginal discoloration), and development of caries by ICDAS after 1, 6, and 12 months. The Wilcoxon, x² of independence, Kaplan-Meier, and Mantel-Cox survival statistical tests were applied (α = 5%).
RESULTS


The total retention was higher for FS (57.1%) at all periods, and there was no difference in the quality of sealants at all periods. The ICDAS decreased after 6 (p = 0.025) and 12 months (p = 0.027) for both materials. Despite the lower retention of BS, the clinical quality of sealants over 12 months were similar.
CONCLUSION


Teeth sealed with BS presented higher sound teeth predominance (ICDAS 0) compared to FS sealant, even with a higher loss of material.
CLINICAL RELEVANCE


Eruption of permanent molars is a relevant period, and the prevention/management of initial caries is essential in these critical stages. Sealants can be an important prevention strategy. After 12 months of follow-up, there was a major failure of the bioactive sealant but without the development of caries lesions.",2021,The ICDAS decreased after 6 (p = 0.025) and 12 months (p = 0.027) for both materials.,"['of newly erupted permanent molars sealed with bioactive self-etching sealants with pre-reacted glass ionomer (S-PRG', 'Eruption of permanent molars', 'newly erupted molars', '56 permanent second molars in stages 2 and 3 of crown eruption; ICDAS (International Caries Detection and Assessment System) was between 0 and 2']","['conventional resin sealant (FS), Fluroshield (Dentsply), or bioactive self-etch sealant (BS), BeautiSealant with S-PRG (Shofu', 'Bioactive self-etching sealant', 'FS sealant']","['Wilcoxon, x² of independence, Kaplan-Meier, and Mantel-Cox survival', 'quality of sealants', 'total retention', 'retention, survival rate, and evolution of caries', 'retention, quality of sealant remnant (anatomical shape, marginal adaptation, surface texture, and marginal discoloration), and development of caries by ICDAS', 'ICDAS']","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}]","[{'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",,0.130706,The ICDAS decreased after 6 (p = 0.025) and 12 months (p = 0.027) for both materials.,"[{'ForeName': 'Karla Janilee de Souza', 'Initials': 'KJS', 'LastName': 'Penha', 'Affiliation': 'Dental Post-Graduation Program, Department of Dentistry, Federal University of Maranhão (UFMA), São Luís- MA, Brasil.'}, {'ForeName': 'Fábia Regina Vieira de Oliveira', 'Initials': 'FRVO', 'LastName': 'Roma', 'Affiliation': 'Dental Post-Graduation Program, Department of Dentistry, Federal University of Maranhão (UFMA), São Luís- MA, Brasil.'}, {'ForeName': 'Etevaldo Matos Maia', 'Initials': 'EMM', 'LastName': 'Filho', 'Affiliation': 'Programa de pós-graduação em Odontologia, Universidade CEUMA, São Luís-MA, Brasil.'}, {'ForeName': 'Cecilia Claudia Costa', 'Initials': 'CCC', 'LastName': 'Ribeiro', 'Affiliation': 'Dental Post-Graduation Program, Department of Dentistry, Federal University of Maranhão (UFMA), São Luís- MA, Brasil; Department of Dentistry II, Federal University of Maranhão, São Luís- MA, Brasil.'}, {'ForeName': 'Leily Macedo', 'Initials': 'LM', 'LastName': 'Firoozmand', 'Affiliation': 'Dental Post-Graduation Program, Department of Dentistry, Federal University of Maranhão (UFMA), São Luís- MA, Brasil; Department of Dentistry I, Federal University of Maranhão, São Luís- MA, Brasil. Electronic address: leily.firoozmand@ufma.br.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103857']
2033,34699943,Repetitive training of contralateral limb through reconsolidation strengthens motor skills.,"Consolidated memories become transiently labile after memory reactivation, allowing update through reconsolidation. Although previous reports have indicated that the effects of post-reactivation training depend on the type of practice, it is unclear whether post-reactivation motor skill training of one limb can enhance the performance of the opposite limb. The present study aimed to investigate whether post-reactivation training (performing an isometric pinch force task) under two different training conditions using the left limb would enhance motor skills of the right limb through reconsolidation. Motor skills were measured in 38 healthy right-handed young adults during three sessions (S): S1 (right-hand training), S2 (memory reactivation and left-hand training 6 h after S1), and S3 (right-hand motor skill test 24 h after S1). Participants were assigned to one of three groups according to the task performed during S2: untrained controls (no training), left-hand training (constant force conditions), or left-hand training (variable force conditions). Left-hand training after memory reactivation during S2 significantly enhanced the motor skills of the right hand. Notably, constant training conditions significantly increased performance compared to the control group. These findings suggest that post-reactivation training in one limb effectively enhances motor skills in the opposite limb, and the effects depend on the training strategy, which has important implications for motor rehabilitation.",2021,"Notably, constant training conditions significantly increased performance compared to the control group.",['38 healthy right-handed young adults'],"['post-reactivation training', 'Repetitive training of contralateral limb through reconsolidation strengthens motor skills', 'S2: untrained controls (no training), left-hand training (constant force conditions), or left-hand training (variable force conditions']",['Motor skills'],"[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",38.0,0.00313858,"Notably, constant training conditions significantly increased performance compared to the control group.","[{'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Gyoda', 'Affiliation': 'Department of Physical Therapy, Nagoya University Graduate School of Medicine, Nagoya, Japan; Department of Neurology, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'Department of Physical Therapy, Nagoya University Graduate School of Medicine, Nagoya, Japan; Graduate School of Health Sciences, Toyohashi SOZO University, Toyohashi, Japan.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Sensorimotor Neuroscience, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Nojima', 'Affiliation': 'Division of Physical Therapy, Shinshu University School of Health Sciences, Matsumoto, Nagano, Japan. Electronic address: nojima@shinshu-u.ac.jp.'}]",Neuroscience letters,['10.1016/j.neulet.2021.136306']
2034,34702437,Effect of Multimedia Messaging Service on Exercise Self-efficacy in Diabetic Patients.,"Objectives:  To increase patients' self-efficacy for initiation of physical activity, there is a need to include physical activity into patient education in clinic settings. In this study, we aimed to assess the effectiveness of multimedia messaging service (MMS) education on exercise self-efficacy in patients with type 2 diabetes mellitus (T2DM).  Methods:  We used a quasi-experimental, pretest-posttest design to study 98 patients with T2DM. The intervention group received MMS education targeting exercise self-efficacy for 2 months, and the control group received routine care only. Patients in both groups completed the Exercise Self-efficacy scale at 3 stages (at baseline, at 4 weeks, and at 8 weeks post-intervention).  Results:  We found a slight increase between baseline, first follow-up, and second follow-up in interpersonal and competing demands factors in the intervention group (p = .002, p = .001, respectively), but no improvement in the control group in any of the 3 factors over time (p > .05). Also, Cohen's d values indicated a medium effect size in all exercise self-efficacy subscales ( interpersonal  [0.734],  competing demands  [0.665], and  internal feelings  [0.696]).  Conclusions:  Health education using theoretically-based MMS targeting exercise self-efficacy was effective and affordable in promoting and changing patients' beliefs and physical activity behaviors.",2021,"We found a slight increase between baseline, first follow-up, and second follow-up in interpersonal and competing demands factors in the intervention group (p = .002, p = .001, respectively), but no improvement in the control group in any of the 3 factors over time (p > .05).","['98 patients with T2DM', 'patients with type 2 diabetes mellitus (T2DM', 'Diabetic Patients']","['MMS education', 'Multimedia Messaging Service', 'multimedia messaging service (MMS) education', 'control group received routine care only']","['Exercise Self-efficacy scale', 'exercise self-efficacy', 'Exercise Self-efficacy', 'exercise self-efficacy subscales']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0025706', 'cui_str': 'Methylmesilate'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",98.0,0.00910221,"We found a slight increase between baseline, first follow-up, and second follow-up in interpersonal and competing demands factors in the intervention group (p = .002, p = .001, respectively), but no improvement in the control group in any of the 3 factors over time (p > .05).","[{'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Alyahya', 'Affiliation': 'Mohammad S. Alyahya, Associate Professor, Department of Health Management and Policy, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan;, Email: msalyahya@just.edu.jo.'}, {'ForeName': 'Nihaya A', 'Initials': 'NA', 'LastName': 'Al-Sheyab', 'Affiliation': 'Nihaya A. Al-Sheyab, Professor of Child and Adolescent Health, Allied Medical Sciences Department/Faculty of Applied Medical Sciences, Adjunct Professor, Faculty of Nursing, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Jumana A', 'Initials': 'JA', 'LastName': 'Alqudah', 'Affiliation': 'Jumana A. Alqudah, Department of Public Health, Community Medicine and Family Medicine, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Othman Beni', 'Initials': 'OB', 'LastName': 'Younis', 'Affiliation': 'Othman Beni Younis, MD, Clinical Assistant Professor of Family Medicine, Department of Public Health, Community Medicine and Family Medicine, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Yousef S', 'Initials': 'YS', 'LastName': 'Khader', 'Affiliation': 'Yousef S. Khader, Professor of Epidemiology, Medical Education and Biostatistics, Department of Public Health, Community Medicine and Family Medicine, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan.'}]",American journal of health behavior,['10.5993/AJHB.45.5.10']
2035,34702431,Effects of Integrated Health Education Combined with Life Intervention on Patients with Coronary Atherosclerotic Heart Disease Complicated with Hyperlipidemia.,"Objectives:  In this study, we assessed the effects of integrated health education combined with life intervention on patients with coronary atherosclerotic heart disease (CHD) complicated with hyperlipidemia.  Methods:  We selected 96 patients with CHD complicated with hyperlipidemia being treated in our hospital from June 2018 to June 2020, and assigned them to a control group (N=48) or a research group (N=48). Patients in the control group received integrated health education, whereas those in the research group were given integrated health education combined with life intervention. We measured outcomes, including blood lipid levels, electrocardiogram (ECG) recovery times, lengths of hospital stay, compliance with nursing intervention, and satisfaction with nursing care.  Results:  After intervention, the total effective rate of nursing in the research group was 93.75% which was higher than for the control group 79.17%. In the research group, the levels of total cholesterol, triglyceride, and low-density lipoprotein cholesterol were higher than those in control group, and the level of high-density lipoprotein cholesterol was lower than that in control group. The length of hospital stay and ECG recovery time were longer than those in research group. The research group had a higher nursing compliance rate than did the control group (91.67% vs 75.00%), and satisfaction with nursing care also was lower in the control group than in the research group (77.08 % vs 91.67%) (p < .05).  Conclusion:  Integrated health education combined with life intervention has a better nursing effect on patients with CHD complicated with hyperlipidemia, and can contribute to controlling blood lipid level in the normal range, improve nursing satisfaction and compliance of patients, reduce the occurrence of adverse events, shorten the length of hospital stay, and accelerate recovery of patients.",2021,"The research group had a higher nursing compliance rate than did the control group (91.67% vs 75.00%), and satisfaction with nursing care also was lower in the control group than in the research group (77.08 % vs 91.67%) (p < .05).  ","['Patients with Coronary Atherosclerotic Heart Disease Complicated with Hyperlipidemia', 'patients with coronary atherosclerotic heart disease (CHD) complicated with hyperlipidemia', '96 patients with CHD complicated with hyperlipidemia being treated in our hospital from June 2018 to June 2020, and assigned them to a control group (N=48) or a research group (N=48', 'patients with CHD complicated with hyperlipidemia']","['Integrated health education combined with life intervention', 'integrated health education combined with life intervention', 'integrated health education', 'Integrated Health Education Combined with Life Intervention']","['nursing compliance rate', 'level of high-density lipoprotein cholesterol', 'blood lipid levels, electrocardiogram (ECG) recovery times, lengths of hospital stay, compliance with nursing intervention, and satisfaction with nursing care', 'levels of total cholesterol, triglyceride, and low-density lipoprotein cholesterol', 'satisfaction with nursing care', 'length of hospital stay and ECG recovery time', 'total effective rate of nursing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",96.0,0.0184295,"The research group had a higher nursing compliance rate than did the control group (91.67% vs 75.00%), and satisfaction with nursing care also was lower in the control group than in the research group (77.08 % vs 91.67%) (p < .05).  ","[{'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Qiong Luo, Chief Doctor, Department of Cardiology, Chongqing General Hospital, University of Chinese Academy of Sciences, Chongqing, 401147, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': 'Ping Jin, Chief Doctor, Department of Cardiology, Chongqing General Hospital, University of Chinese Academy of Sciences, Chongqing, 401147, China.'}, {'ForeName': 'Hongping', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Hongping Li, Chief Doctor, Department of Cardiology, Chongqing General Hospital, University of Chinese Academy of Sciences, Chongqing, 401147, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Cui', 'Affiliation': 'Kun Cui, Chief Doctor, Department of Cardiology, Chongqing General Hospital, University of Chinese Academy of Sciences, Chongqing, 401147, China;, Email: cuikun@ucas.edu.cn.'}, {'ForeName': 'Tianfeng', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Tianfeng Jiang, Chief Doctor, Department of Cardiology, Chongqing General Hospital, University of Chinese Academy of Sciences, Chongqing, 401147, China.'}]",American journal of health behavior,['10.5993/AJHB.45.5.4']
2036,34703180,The Effect of Oral Simvastatin on the Clinical Outcome of Patients with Severe Traumatic Brain Injury: A Randomized Clinical Trial.,"Background


Despite recent promising pharmacological and technological advances in neurosurgical intensive care, the overall TBI-related mortality and morbidity remain high and still pose a major clinical problem. The aim of this study was to evaluate the effect of oral simvastatin on the clinical outcome of patients with severe TBI.
Methods


In a double-blind placebo-controlled randomized clinical trial a total of 98 patients with severe TBI in Imam Khomeini Hospital in Sari, Iran, were evaluated. Patients who meet the inclusion criteria were randomly allocated into two groups (n=49). In addition to supportive therapies, the intervention group received oral simvastatin (40 mg, daily) for 10 days, and the control group received the placebo (10 days). Patients' Glasgow coma scale (GCS) score, in hospital mortality, duration of mechanical ventilation and length of ICU and neurosurgery ward stay were evaluated during three-time intervals (T1: admission, T2: discharge and T3: one month after discharge).
Results


The percentage of conscious patients was 18.9% (7 cases) in the simvastatin group and 3.1% (1 case) in controls (P=0.06) at T2. One month after discharge (T3) the proportion of conscious patients significantly increased in the simvastatin group compared to control group (64.9 % versus 28.1 %; P=0.002). There was no significant difference for the mean of GCS score between the simvastatin group and control group at T1 (6.41 ± 1.30 versus 6.41 ± 1.28, respectively; P = 0.98). However, the mean score of GCS in patients who received simvastatin was significantly greater than controls at T2 and T3 (p<0.05). There was no significant differences between two group in-terms of length of mechanical ventilation, ICU and neurosurgery ward stay.
Conclusion


According to the results of this study it seems that using simvastatin may be an effective and promising therapeutic modality for improving GCS score during TBI recovery.",2021,One month after discharge (T3) the proportion of conscious patients significantly increased in the simvastatin group compared to control group (64.9 % versus 28.1 %; P=0.002).,"['patients with severe TBI', '98 patients with severe TBI in Imam Khomeini Hospital in Sari, Iran, were evaluated', 'Patients who meet the inclusion criteria', 'Patients with Severe Traumatic Brain Injury']","['simvastatin', 'placebo', 'oral simvastatin', 'Oral Simvastatin']","['Glasgow coma scale (GCS) score, in hospital mortality', 'mean of GCS score', 'duration of mechanical ventilation and length of ICU and neurosurgery ward stay', 'length of mechanical ventilation, ICU and neurosurgery ward stay', 'mean score of GCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0443055', 'cui_str': 'Sari - microbial strain'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]",98.0,0.137161,One month after discharge (T3) the proportion of conscious patients significantly increased in the simvastatin group compared to control group (64.9 % versus 28.1 %; P=0.002).,"[{'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Shafiee', 'Affiliation': 'Department of Neurosurgery, Orthopedics Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Zali', 'Affiliation': 'Functional Neurosurgery Research Center, Shohadaye Tajrish Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Misagh', 'Initials': 'M', 'LastName': 'Shafizad', 'Affiliation': 'Department of Neurosurgery, Orthopedics Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Emami Zeydi', 'Affiliation': 'Department of Medical-Surgical Nursing, Nasibeh School of Nursing and Midwifery, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Ehteshami', 'Affiliation': 'Department of Neurosurgery, Orthopedics Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rezaii', 'Affiliation': 'Student Research Committee, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Tafakhori', 'Affiliation': 'Iranian Center of Neurological Research (ICNR), Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abolhasan', 'Initials': 'A', 'LastName': 'Ertiaei', 'Affiliation': 'Department of Neurosurgery, Imam Khomeini Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Darvishi-Khezri', 'Affiliation': 'Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Khademloo', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Reza Jalili', 'Initials': 'RJ', 'LastName': 'Khoshnood', 'Affiliation': 'Functional Neurosurgery Research Center, Shohadaye Tajrish Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Ethiopian journal of health sciences,['10.4314/ejhs.v31i4.15']
2037,34706268,Randomised controlled trial demonstrating the impact of behaviour change intervention provided by dental professionals to improve gingival health.,"AIMS


To determine impact of oral hygiene behaviour change intervention compared to the prevailing standard of oral hygiene advice provided in general dental practice, on bleeding on probing (BOP) in gingivitis patients, over 3-months. The effect of providing power-brushes was also evaluated.
MATERIALS AND METHODS


NHS dental practices were cluster-randomised to intervention or control (2:1). Dentists at intervention sites received behaviour modification training. Participants were stratified to high (≥20% BOP) or low (<20% BOP) presence of gingivitis and a subset assigned a power-brush. BOP and plaque scores were assessed at baseline and 3-months.
RESULTS


A total of 538 participants (369:169; intervention: control) completed the study. BOP reduced in both gingivitis groups with significantly greater reduction in intervention compared to control group (BOP:38% vs 19%, p = 0.0236); Borderline significance favouring the intervention was demonstrated for the low gingivitis group (BOP:37% vs 15%, p = 0.0523). A highly significant reduction in BOP (intervention vs control) was demonstrated for volunteers who swapped from manual to power-brush (44% vs 37%, p = 0.0039). Plaque score improved more in control than intervention group (Plaque:37% vs 44%, p = 0.00215).
CONCLUSIONS


Behaviour change techniques were readily mastered by the dental professional researchers. The introduction of an oral hygiene behaviour change intervention significantly reduced gingivitis in volunteer patients compared to control at 3 months. Swapping to a power-brush significantly favoured BOP reduction compared to manual brush continuation although plaque reduction did not follow expectation in comparison to BOP scores. Behaviour change techniques should routinely be considered in patient care.
CLINICAL SIGNIFICANCE


Plaque-induced gingivitis is highly prevalent in the UK despite being preventable with good oral hygiene. Its continuum, periodontitis, negative impacts quality of life. This study suggests oral hygiene behavioural interventions (GPS) significantly reduce gingivitis and that GPS introduction will improve oral health and may improve quality of life.",2021,The introduction of an oral hygiene behaviour change intervention significantly reduced gingivitis in volunteer patients compared to control at 3 months.,"['NHS dental practices were cluster-randomised to intervention or control (2:1', 'A total of 538 participants (369:169; intervention: control) completed the study', 'gingivitis patients, over 3-months', 'Participants were stratified to high (≥20% BOP) or low (<20% BOP) presence of gingivitis and a subset assigned a power-brush', 'volunteer patients']","['behaviour change intervention', 'behaviour modification training', 'oral hygiene behaviour change intervention', 'oral hygiene behavioural interventions (GPS']","['quality of life', 'gingivitis', 'bleeding on probing (BOP', 'BOP', 'BOP reduction', 'gingival health', 'BOP and plaque scores', 'Plaque score']","[{'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",538.0,0.0174664,The introduction of an oral hygiene behaviour change intervention significantly reduced gingivitis in volunteer patients compared to control at 3 months.,"[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Holloway', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol BS1 2LY, United Kingdom. Electronic address: jessica.naylor@bristol.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol BS1 2LY, United Kingdom. Electronic address: maria.davies@bristol.ac.uk.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'McCarthy', 'Affiliation': ""King's College London, WC2R 2LS, United Kingdom. Electronic address: claire.mccarthy@qstt.nhs.uk.""}, {'ForeName': 'Iftekhar', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'University of Warwick, CV4 7AL, United Kingdom. Electronic address: i.khan.2@warwick.ac.uk.'}, {'ForeName': 'Nicholas C A', 'Initials': 'NCA', 'LastName': 'Claydon', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol BS1 2LY, United Kingdom. Electronic address: n.claydon@bristol.ac.uk.'}, {'ForeName': 'Nicola X', 'Initials': 'NX', 'LastName': 'West', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol BS1 2LY, United Kingdom. Electronic address: N.X.West@bristol.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103862']
2038,34688059,Effect of aerobic exercise on executive function in individuals with methamphetamine use disorder: Modulation by the autonomic nervous system.,"This study assessed the effects of aerobic exercise on cardiac autonomic nervous system function (based on heart rate variability [HRV]) and executive function among individuals with methamphetamine use disorder (MUD). We further examine the role of autonomic nervous system control in aerobic exercise (assessed via cardiopulmonary fitness) and executive function. A total of 330 individuals with MUD were randomly divided into exercise (n = 165) and control (n = 165) groups, who underwent eight-week aerobic exercise/health education program consisting of five 60 min sessions a week. The outcome measures included cardiopulmonary fitness, HRV time-domain and frequency-domain parameters, and executive function. Our statistical analyses comprised repeated-measures analyses of variance, correlation analyses, and mediation and moderation effect tests. The results indicated that aerobic exercise could simultaneously improve autonomic nervous system function and executive function among individuals with MUD. Moreover, the changes in cardiopulmonary fitness, high frequency HRV, and executive function were positively correlated. HRV did not significantly mediate the relationship between aerobic exercise and executive function; however, it did have a moderating effect, which was eliminated after adjusting for demographic and drug-use covariates. Among the covariates, age was the greatest confounder and was inversely proportional to cardiopulmonary function, HRV, and executive function. Cardiac autonomic nervous system function exerted a moderating, rather than a mediating, effect on the relationship between aerobic exercise and executive function. However, this potential effect was largely influenced by covariates, particularly age.",2021,"HRV did not significantly mediate the relationship between aerobic exercise and executive function; however, it did have a moderating effect, which was eliminated after adjusting for demographic and drug-use covariates.","['individuals with MUD', '330 individuals with MUD', 'individuals with methamphetamine use disorder', 'individuals with methamphetamine use disorder (MUD']","['aerobic exercise/health education program', 'aerobic exercise']","['cardiopulmonary fitness, HRV time-domain and frequency-domain parameters, and executive function', 'autonomic nervous system function and executive function', 'cardiac autonomic nervous system function', 'cardiopulmonary function, HRV, and executive function', 'executive function', 'cardiopulmonary fitness, high frequency HRV, and executive function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517719', 'cui_str': '330'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0234593', 'cui_str': 'Autonomic nervous system function'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]",330.0,0.015343,"HRV did not significantly mediate the relationship between aerobic exercise and executive function; however, it did have a moderating effect, which was eliminated after adjusting for demographic and drug-use covariates.","[{'ForeName': 'Xiao-Xia', 'Initials': 'XX', 'LastName': 'Liu', 'Affiliation': 'School of Physical Education and Sport Science, Fujian Normal University, 1 Keji Road, Minhou District, Fuzhou, Fujian 350117, China.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Physical Education and Sport Science, Fujian Normal University, 1 Keji Road, Minhou District, Fuzhou, Fujian 350117, China. Electronic address: fjwangshen@163.com.'}]",Psychiatry research,['10.1016/j.psychres.2021.114241']
2039,34695550,The Effect of Diabetes on Abdominal Aortic Aneurysm Growth Over Two Years.,"INTRODUCTION


Abdominal Aortic Aneurysm (AAA) is a common progressive disease and a significant cause of morbidity and mortality. Prior investigations have shown that diabetes mellitus (DM) may be relatively protective of AAA incidence and growth. The Non-invasive Treatment of Aortic Aneurysm Clinical Trial (N-TA3CT) is a contemporary study of small AAA growth which provides a unique opportunity to validate and explore the effect of DM on AAA. Confirming the effect of DM on AAA growth in this study may present opportunities to explore for clues to potential biologic mechanisms as well as inform current patient management.
METHODS


This is a secondary analysis examining the association of diabetes and aneurysm growth within N-TA 3 CT: a placebo-controlled multicenter trial of doxycycline in 261 patients with AAA maximum transverse diameters (MTD) between 3.5cm and 5cm. The primary outcome is the change in the MTD from baseline as determined by CT scans obtained during the trial. Secondary outcome is the growth pattern of the AAA. Baseline characteristics and growth patterns were assessed with t-tests (continuous) or chi-square tests (categorical). Unadjusted and adjusted longitudinal analyses were performed with a repeated measures linear mixed model to compare AAA growth rates between diabetic patients and non-diabetic patients.
RESULTS


Of 261 patients, 250 subjects had sufficient imaging and were included in this study. There were 56 (22.4%) with diabetes and 194 (77.6%) without. Diabetes was associated with higher BMI and increased rates of hypercholesterolemia and coronary artery disease (p< 0.05). Diabetes was also associated with increased frequency of treatment for atherosclerosis and hypertension including treatment with statin, angiotensin-converting enzyme inhibitor, ARB, anti-platelet, and diuretic therapy (p< 0.05). Baseline MTD was not significantly different between those with (4.32 cm) and without diabetes (4.30 cm). Median growth rate for diabetic patients was 0.12 cm/year (IQR 0.07-0.22) and 0.19 cm/year (IQR 0.12-0.27) in patients without diabetes, which was significantly different on unadjusted analysis (p<0.0001). Diabetes remained significantly associated with AAA growth after adjustment for other relevant clinical factors (coef -0.057; p<0.0001).
CONCLUSIONS


Patients with diabetes have more than a 35% reduction in the median growth rates of AAA despite more severe concomitant vascular co-morbidities and similar initial sizes of aneurysms. This effect persists and remains robust after adjusted analysis; and slower growth rates may delay the time to reach repair threshold. Rapid growth (>0.5 cm/year) is infrequent in diabetic patients.",2021,Diabetes was associated with higher BMI and increased rates of hypercholesterolemia and coronary artery disease (p< 0.05).,"['261 patients', 'diabetic patients', '261 patients with AAA maximum transverse diameters (MTD) between 3.5cm and 5cm', '250 subjects had sufficient imaging and were included in this study', 'diabetic patients and non-diabetic patients']","['doxycycline', 'placebo']","['AAA growth', 'Baseline MTD', 'growth pattern of the AAA', 'rates of hypercholesterolemia and coronary artery disease', 'change in the MTD', 'median growth rates of AAA', 'Median growth rate', 'AAA growth rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1156245', 'cui_str': 'Growth pattern'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}]",261.0,0.0885833,Diabetes was associated with higher BMI and increased rates of hypercholesterolemia and coronary artery disease (p< 0.05).,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Nordness', 'Affiliation': 'Vanderbilt University Medical Center and Vanderbilt University School of Medicine, Department of Vascular Surgery, 1161 21(st) Avenue South, Nashville, TN 37232.'}, {'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Baxter', 'Affiliation': 'University of Nebraska Medical Center, Department of Surgery, Division of Vascular Surgery, 983280 Nebraska Medical Center, Omaha, NE 68198.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Matsumura', 'Affiliation': 'University of Wisconsin, Medicine and Public Health, Department of Surgery, 600 Highland Avenue, Madison, WI 53792.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Terrin', 'Affiliation': 'University of Maryland School of Medicine, Department of Epidemiology and Public Health, Division of Gerontology, 660 W. Redwood Street, Baltimore, MD 21201.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Vanderbilt University School of Medicine, Department of Biostatistics, 2209 Garland Ave, Nashville, TN, 37240.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Vanderbilt University School of Medicine, Department of Biostatistics, 2209 Garland Ave, Nashville, TN, 37240.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Webb', 'Affiliation': 'University of Kentucky College of Medicine, Department of Pharmacology and Nutritional Sciences, 553 CT Wethington Building, Lexington, KY, 40536.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Dalman', 'Affiliation': 'Stanford University School of Medicine Department of Surgery-Vascular Surgery, 300 Pasteur Dr, Stanford, CA, 94305.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Curci', 'Affiliation': 'Vanderbilt University Medical Center and Vanderbilt University School of Medicine, Department of Vascular Surgery, 1161 21(st) Avenue South, Nashville, TN 37232. Electronic address: john.curci@vumc.org.'}]",Journal of vascular surgery,['10.1016/j.jvs.2021.10.019']
2040,34695451,The effect of high-definition transcranial direct current stimulation on pain processing in a healthy population: A single-blinded crossover controlled study.,"Transcranial direct current stimulation (tDCS) is increasingly used in pain treatment. tDCS targeting both primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) may modulate the descending pain inhibitory system, however, it remains controversial regarding the optimal stimulation region for pain modulation. Therefore, this study aimed to explore the effects of high-definition anodic stimulation of M1 and DLPFC on conditioned pain modulation (CPM) and pain thresholds and establish a preferred stimulation setting. Twenty-six healthy adults were randomly assigned to M1-tDCS, DLPFC-tDCS, or sham-tDCS groups. During the three sessions, each participant received an active or sham stimulation of 2 mA for 20 min, with at least 3 days' interval between sessions. Quantitative sensory tests were performed to obtain pressure pain threshold (PPT), cold pain threshold (CPT), and CPM before and after the tDCS intervention. Only M1-tDCS significantly increased CPM in healthy individuals compared with sham control (P = 0.004). No statistically significant difference was found in PPT and CPT between tDCS vs. sham control (P > 0.05). Our findings further support the important role of M1 as a target in pain regulation. Further large-scale, multicenter studies in chronic pain populations are needed to validate the alterations of distinct target brain regions related to pain and thus for an optimal target stimulation strategy in pain management.",2021,Only M1-tDCS significantly increased CPM in healthy individuals compared with sham control (P = 0.004).,"['a healthy population', 'Twenty-six healthy adults']","['M1-tDCS, DLPFC-tDCS, or sham-tDCS', 'tDCS', 'M1 and DLPFC', 'Transcranial direct current stimulation (tDCS', 'high-definition transcranial direct current stimulation']","['PPT and CPT', 'pressure pain threshold (PPT), cold pain threshold (CPT), and CPM', 'CPM', 'pain processing', 'conditioned pain modulation (CPM) and pain thresholds']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",26.0,0.0616741,Only M1-tDCS significantly increased CPM in healthy individuals compared with sham control (P = 0.004).,"[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Sport Rehabilitation, Shanghai University of Sport, Shanghai, China; Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ruihan', 'Initials': 'R', 'LastName': 'Wan', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Department of Sport Rehabilitation, Shenyang Sport University, Shenyang, China.'}, {'ForeName': 'Beibei', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Department of Orthopedics & Traumatology, The University of Hong Kong, HKSAR, China.'}, {'ForeName': 'Ziping', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Department of Sport Rehabilitation, Shenyang Sport University, Shenyang, China.'}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: wangyul@mail.sysu.edu.cn.'}]",Neuroscience letters,['10.1016/j.neulet.2021.136304']
2041,34695444,Respiratory monitoring during neonatal resuscitation using a supraglottic airway device vs. a face mask.,"OBJECTIVE


To evaluate the respiratory function of asphyxiated infants resuscitated with i-gel supraglottic airway (SGA) vs. face mask (FM) in a low-resource setting.
METHODS


In this sub-study from the NeoSupra trial, respiratory function during the first 60 inflations was evaluated in 46 neonates (23 with SGA and 23 with FM) at the Mulago National Referral Hospital, Uganda. The primary outcome was the mask leak (%). The secondary outcomes included inspired (VTi) and expired (VTe) tidal volumes, and heart rate response to ventilation.
RESULTS


Median mask leak was 40% (IQR 22-52) with SGA and 39% (IQR 26-62) with FM (p = 0.38). Median VTe was 7.8 ml/kg (IQR 5.6-10.2) with SGA and 7.3 ml/kg (IQR 4.8-11.9) with FM (p = 0.84), while median VTi was 15.4 ml/kg (IQR 11-4-17.6) with SGA and 15.9 ml/kg (IQR 9.0-22.6) with FM (p = 0.68). A shorter time was needed to achieve heart rate > 100 bpm in SGA (median 13 s IQR 9-15) with respect to FM arm (median 61, IQR 33-140) (p = 0.0002).
CONCLUSION


Respiratory function was not statistically different between neonates resuscitated with SGA vs. FM. SGA was associated with faster heart rate recovery compared to FM in the subgroup of neonates with bradycardia. Further research is needed to investigate possible advantages of SGA on respiratory function at birth.",2021,"Median VTe was 7.8 ml/kg (IQR 5.6-10.2) with SGA and 7.3 ml/kg (IQR 4.8-11.9) with FM (p=0.84), while median VTi was 15.4 ml/kg (IQR 11-4-17.6) with SGA and 15.9 ml/kg (IQR 9.0-22.6) with FM (p=0.68).","['46 neonates (23 with SGA and 23 with FM) at the Mulago National Referral Hospital, Uganda']","['supraglottic airway device vs. a face mask', 'SGA vs. FM', 'asphyxiated infants resuscitated with i-gel supraglottic airway (SGA) vs. face mask (FM', 'SGA', 'FM']","['Median VTe', 'heart rate', 'median VTi', 'heart rate recovery', 'inspired (VTi) and expired (VTe) tidal volumes, and heart rate response to ventilation', 'mask leak', 'Median mask leak']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}]",,0.162581,"Median VTe was 7.8 ml/kg (IQR 5.6-10.2) with SGA and 7.3 ml/kg (IQR 4.8-11.9) with FM (p=0.84), while median VTi was 15.4 ml/kg (IQR 11-4-17.6) with SGA and 15.9 ml/kg (IQR 9.0-22.6) with FM (p=0.68).","[{'ForeName': 'Nicolas J', 'Initials': 'NJ', 'LastName': 'Pejovic', 'Affiliation': ""Centre for International Health, University of Bergen, Bergen, Norway; Neonatal Unit, Sachs' Children and Youth Hospital, Stockholm, Sweden; Karolinska Institute, Department of Public Health Sciences, Stockholm, Sweden. Electronic address: njpejovic@live.se.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cavallin', 'Affiliation': 'Independent Statistician, Solagna, Italy.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Mpamize', 'Affiliation': 'Mulago National Referral Hospital, Kampala, Uganda.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Lubulwa', 'Affiliation': 'Mulago National Referral Hospital, Kampala, Uganda.'}, {'ForeName': 'Susanna Myrnerts', 'Initials': 'SM', 'LastName': 'Höök', 'Affiliation': ""Centre for International Health, University of Bergen, Bergen, Norway; Neonatal Unit, Sachs' Children and Youth Hospital, Stockholm, Sweden; Karolinska Institute, Department of Public Health Sciences, Stockholm, Sweden.""}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': 'Mulago National Referral Hospital, Kampala, Uganda; Dept. of Obstetrics and Gynecology, College of Health Sciences, Makerere University, Uganda.'}, {'ForeName': 'Jolly', 'Initials': 'J', 'LastName': 'Nankunda', 'Affiliation': 'Mulago National Referral Hospital, Kampala, Uganda; Dept. of Pediatrics and Child Health, College of Health Sciences, Makerere University, Uganda.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway; Centre for Intervention Studies in Maternal and Child Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Trevisanuto', 'Affiliation': ""Dept. of Woman's and Child's Health, University of Padova, Padova, Italy.""}]",Resuscitation,['10.1016/j.resuscitation.2021.10.025']
2042,34700023,Operative outcomes for wide awake local anesthesia versus regional and general anesthesia for flexor tendon repair.,"Operative repair of flexor tendons after traumatic injury may be performed under general anesthesia (GA), regional blocks, or a wide-awake local anesthesia no tourniquet (WALANT) technique. To our knowledge there are currently no large-scale reports evaluating outcomes of flexor tendon repair in patients where wide-awake anesthesia was utilized in comparison to regional anesthesia (RA) and general anesthesia. We performed a retrospective analysis of patients who underwent treatment for flexor tendon injuries at a tertiary referral center for hand surgery over a two-year period. A total of 151 patients were included (53 WALANT, 57 RA, and 41 GA) and a total of 251 tendons were repaired (63 WALANT, 104 RA and 84 GA). No statistically significant difference was observed in rates of tendon rupture, adhesions, infection, or hand function. Flexor tendon repair under WALANT is found to be safe and presents comparable operative and functional outcomes to more traditional anesthetic techniques. Additional advantages, including the ability to test the repair intraoperatively, patient education, and the potential for boosting theatre efficiency. Further studies, preferably utilizing a randomized trial methodology, may further elucidate the benefits and risks of WALANT versus regional and general anesthesia.",2021,Flexor tendon repair under WALANT is found to be safe and presents comparable operative and functional outcomes to more traditional anesthetic techniques.,"['flexor tendon repair', 'A total of 151 patients were included (53 WALANT, 57 RA, and 41 GA) and a total of 251 tendons were repaired (63 WALANT, 104 RA and 84 GA', 'patients who underwent treatment for flexor tendon injuries at a tertiary referral center for hand surgery over a two-year period']","['wide awake local anesthesia versus regional and general anesthesia', 'general anesthesia (GA), regional blocks, or a wide-awake local anesthesia no tourniquet (WALANT) technique']","['rates of tendon rupture, adhesions, infection, or hand function']","[{'cui': 'C0224848', 'cui_str': 'Structure of flexor tendon'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0151937', 'cui_str': 'Rupture of tendon'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}]",251.0,0.116308,Flexor tendon repair under WALANT is found to be safe and presents comparable operative and functional outcomes to more traditional anesthetic techniques.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kadhum', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, 10 Pond Street, London, NW3 2QG, United Kingdom. Electronic address: murtaza.kadhum@nhs.net.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Georgiou', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, 10 Pond Street, London, NW3 2QG, United Kingdom.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kanapathy', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, 10 Pond Street, London, NW3 2QG, United Kingdom; Division of Surgery & Interventional Science, University College London, Royal Free Hospital, 9th Floor (East), 10 Pond Street, London NW3 2PS, United Kingdom.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Reissis', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, 10 Pond Street, London, NW3 2QG, United Kingdom.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Akhavani', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, 10 Pond Street, London, NW3 2QG, United Kingdom.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Burr', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, 10 Pond Street, London, NW3 2QG, United Kingdom.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nikkhah', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, 10 Pond Street, London, NW3 2QG, United Kingdom; Division of Surgery & Interventional Science, University College London, Royal Free Hospital, 9th Floor (East), 10 Pond Street, London NW3 2PS, United Kingdom. Electronic address: d.nikkhah@nhs.net.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2021.10.312']
2043,34689056,Measuring brain glucose metabolism in order to predict response to antidepressant or placebo: A randomized clinical trial.,"There is critical need for a clinically useful tool to predict antidepressant treatment outcome in major depressive disorder (MDD) to reduce suffering and mortality. This analysis sought to build upon previously reported antidepressant treatment efficacy prediction from 2-[ 18 F]-fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) using metabolic rate of glucose uptake (MRGlu) from dynamic FDG-PET imaging with the goal of translation to clinical utility. This investigation is a randomized, double-blind placebo-controlled trial. All participants were diagnosed with MDD and received an FDG-PET scan before randomization and after treatment. Hamilton Depression Rating Scale (HDRS-17) was completed in participants diagnosed with MDD before and after 8 weeks of escitalopram, or placebo. MRGlu (mg/(min*100 ml)) was estimated within the raphe nuclei, right insula, and left ventral Prefrontal Cortex in 63 individuals. Linear regression was used to examine the association between pretreatment MRGlu and percent decrease in HDRS-17. Additionally, the association between percent decrease in HDRS-17 and percent change in MRGlu between pretreatment scan and post-treatment scan was examined. Covariates were treatment type (SSRI/placebo), handedness, sex, and age. Depression severity decrease (n = 63) was not significantly associated with pretreatment MRGlu in the raphe nuclei (β = -2.61e -03  [-0.26, 0.25], p = 0.98), right insula (β = 0.05 [-0.23, 0.32], p = 0.72), or ventral prefrontal cortex (β = 0.06 [-0.23, 0.34], p = 0.68) where β is the standardized estimated coefficient, with a 95% confidence interval, or in whole brain voxelwise analysis (family-wise error correction, alpha = 0.05). MRGlu percent change was not significantly associated with depression severity decrease (n = 58) before multiple comparison correction in the RN (β = 0.20 [-0.07, 0.47], p = 0.15), right insula (β = 0.24 [-0.03, 0.51], p = 0.08), or vPFC (β = 0.22 [-0.06, 0.50], p = 0.12). We propose that FDG-PET imaging does not indicate a clinically relevant biomarker of escitalopram or placebo treatment response in heterogeneous major depressive disorder cohorts. Future directions include focusing on potential biologically-based subtypes of major depressive disorder by implementing biomarker stratified designs.",2021,Depression severity decrease (n = 63) was not significantly associated with pretreatment MRGlu in the raphe nuclei (β = ,"['All participants were diagnosed with MDD and received an', '2.61e -03']","['placebo', '2-[ 18 F]-fluorodeoxyglucose - Positron Emission Tomography (FDG-PET', 'FDG-PET scan']","['depression severity decrease', 'ventral prefrontal cortex ', 'Hamilton Depression Rating Scale (HDRS-17', 'Depression severity decrease', 'HDRS-17']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0302995', 'cui_str': 'Fluorine-18'}, {'cui': 'C3641247', 'cui_str': 'FDG PET scan'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}]",,0.219821,Depression severity decrease (n = 63) was not significantly associated with pretreatment MRGlu in the raphe nuclei (β = ,"[{'ForeName': 'Kathryn R', 'Initials': 'KR', 'LastName': 'Hill', 'Affiliation': 'Department of Psychiatry, Renaissance School of Medicine at Stony Brook University, 101 Nicolls Rd, Stony Brook, NY, 11794, USA. Electronic address: kathryn.hill@stonybrookmedicine.edu.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Gardus', 'Affiliation': 'Department of Psychiatry, Renaissance School of Medicine at Stony Brook University, 101 Nicolls Rd, Stony Brook, NY, 11794, USA. Electronic address: john.gardus@stonybrookmedicine.edu.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bartlett', 'Affiliation': 'Molecular Imaging and Neuropathology Area, New York State Psychiatric Institute, 1051 Riverside Dr, New York, NY 10032, USA; Department of Psychiatry, Columbia University Medical Center, 1051 Riverside Dr, New York, NY 10032, USA. Electronic address: elizabeth.bartlett@nyspi.columbia.edu.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Perlman', 'Affiliation': 'Department of Psychiatry, Renaissance School of Medicine at Stony Brook University, 101 Nicolls Rd, Stony Brook, NY, 11794, USA. Electronic address: greg.perlman@stonybrookmedicine.edu.'}, {'ForeName': 'Ramin V', 'Initials': 'RV', 'LastName': 'Parsey', 'Affiliation': 'Department of Psychiatry, Renaissance School of Medicine at Stony Brook University, 101 Nicolls Rd, Stony Brook, NY, 11794, USA. Electronic address: ramin.parsey@stonybrookmedicine.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'DeLorenzo', 'Affiliation': 'Department of Psychiatry, Renaissance School of Medicine at Stony Brook University, 101 Nicolls Rd, Stony Brook, NY, 11794, USA; Department of Psychiatry, Columbia University Medical Center, 1051 Riverside Dr, New York, NY 10032, USA. Electronic address: christine.delorenzo@stonybrookmedicine.edu.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2021.102858']
2044,34700074,"Maternal C3 complement and C-reactive protein and pregnancy and fetal outcomes: A secondary analysis of the PEARS RCT-An mHealth-supported, lifestyle intervention among pregnant women with overweight and obesity.","OBJECTIVES


Elevated circulating levels of complement component 3 (C3) and C-reactive protein (CRP) have been linked with adverse pregnancy outcomes. Lifestyle interventions may hold potential to ameliorate these effects. We investigated the effect of an antenatal healthy lifestyle intervention on maternal C3 and CRP concentrations and assessed their relationship with maternal and fetal metabolic markers and outcomes.
STUDY DESIGN


Secondary analysis of data from the Pregnancy Exercise And Nutrition Research Study (PEARS) randomized controlled trial.
METHODS


Women (n = 406) with C3 and CRP concentrations determined in early pregnancy (14-16 weeks) and/or late pregnancy (28-weeks) with corresponding fasting glucose, insulin, c-peptide, and lipid profiles were included in the analysis. Pregnancy outcomes included: diagnoses of gestational diabetes (GDM), pre-eclampsia (PET) or pregnancy induced hypertension (PIH), pre-term birth (delivery < 37 weeks), low birth weight (<2500 g), small-for-gestational age (SGA) defined using < 5th or 10th centile for birthweight and cord blood measures of glucose and lipid metabolism. T-tests investigated changes in C3 and CRP over time. Chi-square, Pearson's' correlations and multiple regression investigated relationships with outcomes.
RESULTS


The PEARS intervention did not influence maternal C3 or CRP concentrations in pregnancy. There was no relationship between CRP concentrations and any maternal or infant outcome. Women who developed GDM had higher C3 concentrations in early (p = 0.01) and late pregnancy (p = 0.02). Women who developed PIH/PET had lower C3 concentrations in early (p = 0.02), but not late (p = 0.10) pregnancy. Maternal C3 concentrations in early pregnancy were a small but significant predictor of maternal insulin concentrations in early (β = 0.40, 95% CI 0.27, 0.53; p < 0.001) and late (β = 0.30, 95% CI 0.17, 0.43p < 0.001) pregnancy, early total cholesterol (TC), and both early and late triglycerides, LDL and HDL Cholesterol concentrations (all p < 0.001). Women who delivered SGA babies (<10th centile) had lower C3 concentrations than women who did not in both early (p < 0.001) and late pregnancy (p = 0.01). No relationship between maternal C3 or CRP and fetal glucose concentrations or lipid profiles was observed.
CONCLUSION


Maternal C3 may play a role in multiple adverse pregnancy outcomes including cardiometabolic ill-health. Further research on this, and strategies to reduce C3 in a pregnant population, are warranted.",2021,Women who delivered SGA babies (<10th centile) had lower C3 concentrations than women who did not in both early (p < 0.001) and late pregnancy (p = 0.01).,"['pregnant women with overweight and obesity', 'Women (n\xa0']","['antenatal healthy lifestyle intervention', 'PEARS RCT-An mHealth-supported, lifestyle intervention']","['lower C3 concentrations', 'Maternal C3 concentrations', 'maternal C3 or CRP and fetal glucose concentrations or lipid profiles', 'late pregnancy', 'maternal insulin concentrations', '\xa00.001) pregnancy, early total cholesterol (TC), and both early and late triglycerides, LDL and HDL Cholesterol concentrations ', 'maternal C3 or CRP concentrations', 'CRP concentrations', 'and/or late pregnancy (28-weeks) with corresponding fasting glucose, insulin, c-peptide, and lipid profiles', 'diagnoses of gestational diabetes (GDM), pre-eclampsia (PET) or pregnancy induced hypertension (PIH), pre-term birth (delivery\xa0<\xa037\xa0weeks), low birth weight (<2500\xa0g), small-for-gestational age (SGA) defined using\xa0<\xa05th or 10th centile for birthweight and cord blood measures of glucose and lipid metabolism', 'C3 concentrations', 'Maternal C3 complement and C-reactive protein and pregnancy and fetal outcomes', 'maternal C3 and CRP concentrations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4517385', 'cui_str': '0.001'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0852036', 'cui_str': 'Pregnancy-induced hypertension'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0953105,Women who delivered SGA babies (<10th centile) had lower C3 concentrations than women who did not in both early (p < 0.001) and late pregnancy (p = 0.01).,"[{'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Kennelly', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin 2, Ireland.'}, {'ForeName': 'Sarah Louise', 'Initials': 'SL', 'LastName': 'Killeen', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin 2, Ireland.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Phillips', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin 4, Ireland.'}, {'ForeName': 'Gouiri', 'Initials': 'G', 'LastName': 'Alberdi', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin 2, Ireland.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Lindsay', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin 2, Ireland; Department of Pediatrics, University of California, Irvine, Irvine, CA, USA; Susan Samueli Integrative Health Institute, UCI College of Health Sciences, Irvine, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mehegan', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin 4, Ireland.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Cronin', 'Affiliation': 'National Maternity Hospital, Dublin 2, Ireland.'}, {'ForeName': 'Fionnuala M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin 2, Ireland. Electronic address: fionnuala.mcauliffe@ucd.ie.'}]",Cytokine,['10.1016/j.cyto.2021.155748']
2045,34689841,"Neurocognitive, psychiatric, and substance use characteristics in a diverse sample of persons with OUD who are starting methadone or buprenorphine/naloxone in opioid treatment programs.","BACKGROUND


Medications for opioid use disorder such as opioid agonist treatment (OAT, including methadone, buprenorphine) are the gold standard intervention for opioid use disorder (OUD). Persons with OUD have high rates of neurocognitive impairment and psychiatric and substance use disorders, but few studies have examined these characteristics in diverse patients initiating OAT in opioid treatment programs (OTPs). Additionally, in these individuals, poor neurocognitive functioning and psychiatric/other substance use disorders are associated with poor OUD treatment outcomes. Given rapid changes in the opioid epidemic, we sought to replicate findings from our pilot study by examining these characteristics in a large diverse sample of persons with OUD starting OTP-based OAT.
METHODS


Ninety-seven adults with OUD (M age = 42.2 years [SD = 10.3]; M education = 11.4 years [SD = 2.3]; 27% female; 22% non-Hispanic white) were enrolled in a randomized longitudinal trial evaluating methadone versus buprenorphine/naloxone on neurocognitive functioning. All participants completed a comprehensive neurocognitive, psychiatric, and substance use evaluation within one week of initiating OAT.
RESULTS


Most of the sample met criteria for learning (79%) or memory (69%) impairment. Half exhibited symptoms of current depression, and comorbid substance use was highly prevalent. Lifetime cannabis and cocaine use disorders were associated with better neurocognitive functioning, while depression was associated with worse neurocognitive functioning.
CONCLUSIONS


Learning and memory impairment are highly prevalent in persons with OUD starting treatment with either methadone or buprenorphine/naloxone in OTPs. Depression and comorbid substance use are prevalent among these individuals, but neither impact learning or memory. However, depression is associated with neurocognitive impairment in other domains. These findings might allow clinicians to help persons with OUD starting OAT to develop compensatory strategies for learning and memory, while providing adjunctive treatment for depression. Trial Registration NCT, NCT01733693. Registered November 4, 2012, https://clinicaltrials.gov/ct2/show/NCT01733693 .",2021,"Lifetime cannabis and cocaine use disorders were associated with better neurocognitive functioning, while depression was associated with worse neurocognitive functioning.
","['persons with OUD who are starting', 'Ninety-seven adults with OUD (M age\u2009=\u200942.2\xa0years [SD\u2009=\u200910.3]; M education\u2009=\u200911.4\xa0years [SD\u2009=\u20092.3]; 27% female; 22% non-Hispanic white', 'persons with OUD starting treatment with either', 'Persons with OUD', 'in opioid treatment programs', 'persons with OUD starting OTP-based OAT']","['methadone', 'methadone or buprenorphine/naloxone', 'buprenorphine/naloxone', 'methadone, buprenorphine']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028753', 'cui_str': 'Oats'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]",[],97.0,0.0992314,"Lifetime cannabis and cocaine use disorders were associated with better neurocognitive functioning, while depression was associated with worse neurocognitive functioning.
","[{'ForeName': 'Travis M', 'Initials': 'TM', 'LastName': 'Scott', 'Affiliation': 'VA Palo Alto Health Care System Sierra Pacific Mental Illness Research Education Clinical Center, 3801 Miranda Ave, Palo Alto, CA, 94304, USA. tshivleyscott@gmail.com.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Arnsten', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'James Patrick', 'Initials': 'JP', 'LastName': 'Olsen', 'Affiliation': 'Department of Neurology, North Shore University Hospital, Manhasset, NY, USA.'}, {'ForeName': 'Franchesca', 'Initials': 'F', 'LastName': 'Arias', 'Affiliation': 'The Aging Brain Center, Hebrew SeniorLife, Boston, MA, USA.'}, {'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Rivera Mindt', 'Affiliation': 'Department of Psychology and Latin America and Latino Studies Institute, Fordham University, New York, NY, USA.'}]",Addiction science & clinical practice,['10.1186/s13722-021-00272-4']
2046,34709363,Intraocular Pressure-Related Events After Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal Vein Occlusion or Hemiretinal Vein Occlusion: SCORE2 Report 16 on a Secondary Analysis of a Randomized Clinical Trial.,"Importance


Intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections are used to treat a variety of posterior segment conditions, including some associated with glaucoma, such as macular edema due to central retinal vein occlusion (CRVO). Therefore, information regarding intraocular pressure (IOP)-related events associated with anti-VEGF therapies is important to help balance the risks and benefits over the course of therapy.
Objective


To investigate IOP-related events among participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2).
Design, Setting, and Participants


Secondary analysis of a randomized clinical trial that included 312 participants with macular edema secondary to CRVO or hemiretinal vein occlusion (HRVO) who were not taking IOP-lowering medications at baseline. First randomization occurred on September 14, 2014, and contained data through data freeze on April 1, 2020. Analysis took place from April 2020 through December 2020.
Interventions


Study participants were initially randomized to 6 monthly intravitreal injections of aflibercept or bevacizumab. At month 6, protocol-defined good responders were rerandomized to continued monthly or treat-and-extend dosing of their originally assigned study drug, and protocol-defined poor or marginal responders were switched to alternative treatment. After month 12, participants were treated as per investigator discretion.
Main Outcomes and Measures


Three different outcomes: (1) IOP elevation more than 10 mm Hg from baseline, (2) IOP to a level higher than 35 mm Hg, and (3) IOP-lowering incisional or laser surgery.
Results


Of the 312 participants meeting inclusion criteria (138 [44.2%] were female; mean [SD] age, 67.8 [12.1] years), 25 (8.0%) had IOP elevation more than 10 mm Hg over baseline through month 60, and 5 (1.6%) had IOP higher than 35 mm Hg. The 60-month Kaplan-Meier cumulative incidence of IOP elevation more than 10 mm Hg over baseline was 0.13 (95% CI, 0.08-0.19), and the 60-month Kaplan-Meier cumulative incidence of IOP higher than 35 mm Hg was 0.02 (95% CI, 0.01-0.06), and did not differ among participants initially randomly assigned to receive aflibercept or bevacizumab. Three participants (1.0%) underwent IOP-lowering incisional surgery, and 3 participants (1.0%) underwent IOP-lowering glaucoma laser surgery.
Conclusions and Relevance


Intravitreal anti-VEGF injections are used to treat some conditions associated with glaucoma, such as macular edema due to CRVO, and the rates of IOP-related events in this trial support monitoring IOP in eyes treated with anti-VEGF therapy for macular edema associated with CRVO or HRVO for up to 60 months.
Trial Registration


ClinicalTrials.gov Identifier: NCT01969708.",2021,"higher than 35 mm Hg was 0.02 (95% CI, 0.01-0.06), and did not differ among participants initially randomly assigned to receive aflibercept or bevacizumab.","['312 participants with macular edema secondary to CRVO or hemiretinal vein occlusion (HRVO) who were not taking IOP-lowering medications at baseline', '312 participants meeting inclusion criteria (138 [44.2%] were female', 'participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2', 'Macular Edema Due to Central Retinal Vein Occlusion or Hemiretinal Vein Occlusion']","['Intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections', 'aflibercept or bevacizumab', 'Anti-Vascular Endothelial Growth Factor Therapy', 'IOP-lowering incisional surgery', 'IOP-lowering glaucoma laser surgery', 'anti-VEGF therapy']","['60-month Kaplan-Meier cumulative incidence of IOP elevation', 'IOP elevation', 'Intraocular Pressure-Related Events', '60-month Kaplan-Meier cumulative incidence of IOP']","[{'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0154841', 'cui_str': 'Central retinal vein occlusion'}, {'cui': 'C1735356', 'cui_str': 'Hemiretinal vein occlusion'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035328', 'cui_str': 'Retinal vein occlusion'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0023087', 'cui_str': 'Laser surgery'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",312.0,0.45275,"higher than 35 mm Hg was 0.02 (95% CI, 0.01-0.06), and did not differ among participants initially randomly assigned to receive aflibercept or bevacizumab.","[{'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Aref', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago.'}, {'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Department of Ophthalmology, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'VanVeldhuisen', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland.'}, {'ForeName': 'Jacquie', 'Initials': 'J', 'LastName': 'King', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ip', 'Affiliation': 'Doheny Eye Institute, University of California, Los Angeles, Los Angeles.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Blodi', 'Affiliation': 'Fundus Photograph Reading Center, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Oden', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2021.4395']
2047,34706311,Denosumab did not improve computerized tomography erosion scores when added to intensive urate-lowering therapy in gout: Results from a pilot randomized controlled trial.,"BACKGROUND/PURPOSE


Disordered osteoclast activity has been implicated in the pathogenesis of gouty bone erosion. We sought to determine if the addition of denosumab (a monoclonal antibody targeting the receptor activator of nuclear factor kappa-B ligand - RANKL) to intensive urate-lowering therapy (ULT) improves gouty bone erosion.
METHODS


Open-label, parallel-group pilot randomized controlled trial in which 20 participants with gout with at least one confirmed conventional radiographic foot bone erosion were assigned in a 1:1 allocation to receive denosumab (60 mg subcutaneous every 6 months) added to intensive ULT (serum urate ≤5 mg/dL or 300 µmol/L at the time of randomization and continued for the duration of the study), or intensive ULT alone. The primary outcome was the change in the bilateral foot and ankle computed tomography (CT) bone erosion score from baseline to 12 months, assessed by an experienced musculoskeletal radiologist blinded to study assignment. Secondary outcomes included change in serum C-terminal telopeptide (CTX), and patient reported outcomes of pain and function.
RESULTS


Although serum CTX declined markedly in the denosumab/ULT group compared with the ULT alone group, there was no interval change in CT erosion score in either the denosumab/ULT or ULT alone group after one year of follow-up. Other secondary outcomes did not differ between groups. There were two severe adverse events: One patient developed atrial fibrillation (on denosumab/ULT) and another atrial flutter (on ULT alone).
CONCLUSIONS


In this pilot study, denosumab did not offer additional benefit to intensive urate lowering therapy for gouty bone erosion.",2021,"Although serum CTX declined markedly in the denosumab/ULT group compared with the ULT alone group, there was no interval change in CT erosion score in either the denosumab/ULT or ULT alone group after one year of follow-up.","['gouty bone erosion', '20 participants with gout with at least one confirmed conventional radiographic foot bone erosion']","['denosumab', 'ULT', 'intensive urate-lowering therapy (ULT', 'denosumab (60\xa0mg subcutaneous every 6 months) added to intensive ULT (serum urate ≤5', 'Denosumab', 'denosumab/ULT', 'denosumab/ULT or ULT']","['severe adverse events', 'change in the bilateral foot and ankle computed tomography (CT) bone erosion score', 'serum CTX', 'interval change in CT erosion score', 'computerized tomography erosion scores', 'change in serum C-terminal telopeptide (CTX), and patient reported outcomes of pain and function', 'atrial fibrillation']","[{'cui': 'C0587240', 'cui_str': 'Bone erosion'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0016505', 'cui_str': 'Bone structure of foot'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0230473', 'cui_str': 'Both feet'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0587240', 'cui_str': 'Bone erosion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",20.0,0.238361,"Although serum CTX declined markedly in the denosumab/ULT group compared with the ULT alone group, there was no interval change in CT erosion score in either the denosumab/ULT or ULT alone group after one year of follow-up.","[{'ForeName': 'Angelo L', 'Initials': 'AL', 'LastName': 'Gaffo', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA; Birmingham VA Medical Center, Birmingham, AL, USA. Electronic address: agaffo@uabmc.edu.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Saag', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Doyle', 'Affiliation': 'University of Auckland, Auckland, New Zealand; Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Melnick', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Horne', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Foster', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Mudano', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Biggers-Clark', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Redden', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2021.10.002']
2048,34704201,"Performance Evaluation of the Glunovo® Continuous Blood Glucose Monitoring System in Chinese Participants with Diabetes: A Multicenter, Self-Controlled Trial.","INTRODUCTION


The present study was aimed to evaluate the performance and safety of the Glunovo® real-time continuous glucose monitoring system (CGMS) in monitoring interstitial fluid glucose in adult participants with diabetes (at least 18 years old) using venous blood glucose as control.
METHODS


This was a multicenter, self-controlled clinical trial, conducted in participants with diabetes from China, between March 2019 to October 2019. The CGMS was used by all the participants for a 14-day wear-in period. The real-time glucose values measured by Glunovo® CGMS were compared with venous blood glucose values measured by the Entwicklung, Konstruktion und Fertigung (EKF) blood glucose detector. The primary outcomes were the consistency rate of CGMS readings and venous blood glucose values (20/20% standard).
RESULTS


A total of 78 participants (41 men, 37 women) and 156 CGMS sensors were included in the study. Among the included participants, 25 and 53 participants had type 1 and type 2 diabetes, respectively, with median age of 52.50 years (range 32-62 years). The overall agreement rate (20/20%) was 89.71% (95% CI 89.18-90.24%). It was observed that 99.08% (95% CI 98.91-99.24%) and 99.82% (95% CI 99.74-99.89%) of the measuring points fell within the A + B zones of the Clarke error grid analysis and Parkes/consensus error grid analysis, respectively. The mean absolute relative difference was 10.30% ± 4.86%. The probability of a glucose measurement falling within a range, when stratified by venous glucose measurements, ranged from 7.14% for 19.44-22.22 mmol/L to 79.21% for 4.44-6.67 mmol/L. There were 73 (41.24%) and 27 (57.45%) successful CGMS alarms for hypoglycemic and hyperglycemic events, respectively.
CONCLUSION


From the results, Glunovo® CGMS had excellent accuracy and limited clinical risk compared with venous blood glucose in the range of 2.2-22.2 mmol/L over 14 days.",2021,The overall agreement rate (20/20%) was 89.71% (95% CI 89.18-90.24%).,"['78 participants (41 men, 37 women) and 156 CGMS sensors were included in the study', 'Chinese Participants with Diabetes', 'participants with diabetes from China, between March 2019 to October 2019', 'adult participants with diabetes (at least 18\xa0years old) using venous blood glucose as control', 'included participants, 25 and 53 participants had type\xa01 and type\xa02 diabetes, respectively, with median age of 52.50\xa0years (range 32-62\xa0years']","['Glunovo® Continuous Blood Glucose Monitoring System', 'Glunovo® real-time continuous glucose monitoring system (CGMS']","['consistency rate of CGMS readings and venous blood glucose values', 'real-time glucose values', 'overall agreement rate', 'successful CGMS alarms for hypoglycemic and hyperglycemic events']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",78.0,0.229809,The overall agreement rate (20/20%) was 89.71% (95% CI 89.18-90.24%).,"[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Meng', 'Affiliation': 'Department of Endocrinology, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, 210008, China.'}, {'ForeName': 'Tianwei', 'Initials': 'T', 'LastName': 'Gu', 'Affiliation': 'Department of Endocrinology, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, 210008, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, 210008, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, 210008, China.'}, {'ForeName': 'Qichao', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, 210008, China.'}, {'ForeName': 'Dalong', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Endocrinology, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, 210008, China. zhudalong@nju.edu.cn.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-021-01171-2']
2049,34700294,"Efficacy of naproxen in the management of patients hospitalized with COVID-19 infection: A randomized, double-blind, placebo-controlled, clinical trial.","BACKGROUND AND AIMS


The current study was done to examine the efficacy of naproxen in the management of patients with COVID-19 infection.
METHODS


This randomized, double-blind, placebo-controlled, clinical trial was done on hospitalized adult patients with confirmed COVID-19 infection. Patients were randomly assigned to receive either naproxen (two capsules per day each containing 500 mg naproxen sodium) or placebo (containing starch) for five days along with the routine treatment that was nationally recommended for COVID-19 infection. Clinical symptoms of COVID-19 infection, the time to clinical improvement, blood pressure, laboratory parameters, and death due to COVID-19 infection were considered as the outcome variables in the present study.
RESULTS


Treatment with naproxen improved cough and shortness of breath in COVID-19 patients; such that, compared with placebo, naproxen intake was associated with 2.90 (95% CI: 1.10-7.66) and 2.82 (95% CI: 1.05-7.55) times more improvement in cough and shortness of breath, respectively. In addition, naproxen administration resulted in a significant increase in mean corpuscular volume (MCV) and had a preventive effect on the reduction of systolic blood pressure in COVID-19 patients.
CONCLUSION


Treatment with naproxen can improve cough and shortness of breath in COVID-19-infected patients. Further studies are required to confirm our findings.",2021,"such that, compared with placebo, naproxen intake was associated with 2.90 (95% CI: 1.10-7.66) and 2.82 (95% CI: 1.05-7.55) times more improvement in cough and shortness of breath, respectively.","['patients with COVID-19 infection', 'patients hospitalized with COVID-19 infection', 'COVID-19 patients', 'hospitalized adult patients with confirmed COVID-19 infection', 'COVID-19-infected patients']","['placebo, naproxen', 'naproxen', 'placebo', 'naproxen sodium) or placebo (containing starch']","['cough and shortness of breath', 'Clinical symptoms of COVID-19 infection, the time to clinical improvement, blood pressure, laboratory parameters, and death due to COVID-19 infection', 'mean corpuscular volume (MCV', 'systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0546873', 'cui_str': 'Naproxen sodium'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0524587', 'cui_str': 'Mean cell volume - finding'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.737931,"such that, compared with placebo, naproxen intake was associated with 2.90 (95% CI: 1.10-7.66) and 2.82 (95% CI: 1.05-7.55) times more improvement in cough and shortness of breath, respectively.","[{'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Asadi', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sayar', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Radmanesh', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Naghshi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sajedeh', 'Initials': 'S', 'LastName': 'Mousaviasl', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Jelvay', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Ebrahimzadeh', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Abbasi', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mobarak', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran. Electronic address: s.mobarak@abadanums.ac.ir.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Bitaraf', 'Affiliation': 'Department of Epidemiology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Zardehmehri', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Cheldavi', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2021.102319']
2050,34709369,Incidence of Second Primary Lung Cancer After Low-Dose Computed Tomography vs Chest Radiography Screening in Survivors of Head and Neck Cancer: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


In head and neck cancer survivors, lung cancer screening may aid in detecting a second primary lung cancer or metastatic head and neck cancer earlier in the course of disease, which may improve treatment outcomes. However, no randomized data exist to assess the value of lung cancer screening in this population.
Objective


To evaluate the incidence of second primary lung cancer in survivors of head and neck cancer survivors with screening low-dose computed tomography (CT) vs chest radiography (CXR).
Design, Setting and Participants


For this ad hoc secondary analysis of a randomized clinical trial, head and neck cancer survivors were identified from the National Lung Screening Trial, which enrolled participants from August 2002 to April 2004. This randomized clinical trial compared screening using low-dose CT chest vs CXR in patients aged 55 to 74 years with at least a 30 pack-year history of cigarette smoking and who were current smokers or had quit within the past 15 years and who were at high risk for lung cancer. The incidences of second primary lung cancer and second primary head and neck cancer were compared with screening using low-dose CT vs CXR. Data were analyzed from December 1, 2020, to June 30, 2021.
Interventions


Screening low-dose CT of the chest vs CXR.
Main Outcomes and Measures


The primary outcome was the incidence of a second primary lung cancer.
Results


Among 53 452 enrolled participants, we identified 171 survivors of head and neck cancer, of whom 82 were screened with low-dose CT of the chest and 89 with CXR. Participants' mean (SD) age was 61 (5) years, and 132 were men (77.2%). The incidence of lung cancer was higher among head and neck cancer survivors compared with participants without head and neck cancer (2080 per 100 000 person-years [2.1%] vs 609 per 100 000 person-years [0.6%]; adjusted rate ratio, 2.54; 95% CI, 1.63-3.95). In head and neck cancer survivors, the incidence of second primary lung cancer was 2610 cases per 100 000 person-years in the low-dose CT group vs 1594 cases per 100 000 person-years in the CXR group (rate ratio, 1.55; 95% CI, 0.59-3.63). In head and neck cancer survivors, overall survival was 7.07 years with low-dose CT vs 6.66 years with CXR (log-rank P = .48).
Conclusions and Relevance


The results of this ad hoc secondary analysis of a randomized clinical trial suggest that head and neck cancer survivors are at especially high risk for a second primary lung cancer. These findings underscore the importance of low-dose CT screening in head and neck cancer survivors with significant cigarette smoking history who are fit to undergo treatment with curative intent.",2021,"In head and neck cancer survivors, overall survival was 7.07 years with low-dose CT vs 6.66 years with CXR (log-rank P = .48).
","['Survivors of Head and Neck Cancer', 'patients aged 55 to 74 years with at least a 30 pack-year history of cigarette smoking and who were current smokers or had quit within the past 15 years and who were at high risk for lung cancer', 'head and neck cancer survivors were identified from the National Lung Screening Trial, which enrolled participants from August 2002 to April 2004', ""Participants' mean (SD) age was 61 (5) years, and 132 were men (77.2"", 'survivors of head and neck cancer survivors with', 'head and neck cancer survivors', '53\u202f452 enrolled participants, we identified 171 survivors of head and neck cancer, of whom 82 were screened with low-dose CT of the chest and 89 with CXR', 'head and neck cancer survivors with significant cigarette smoking history who are fit to undergo treatment with curative intent']","['Low-Dose Computed Tomography vs Chest Radiography Screening', 'screening low-dose computed tomography (CT) vs chest radiography (CXR', 'CT screening', 'screening using low-dose CT chest vs CXR']","['Incidence of Second Primary Lung Cancer', 'incidence of a second primary lung cancer', 'overall survival', 'incidence of second primary lung cancer', 'incidences of second primary lung cancer and second primary head and neck cancer', 'incidence of lung cancer']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4075962', 'cui_str': 'Low dose computed tomography of thorax'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006888', 'cui_str': 'Christmas Island'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0006888', 'cui_str': 'Christmas Island'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]",53452.0,0.37629,"In head and neck cancer survivors, overall survival was 7.07 years with low-dose CT vs 6.66 years with CXR (log-rank P = .48).
","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Cramer', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, Karmanos Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Grauer', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, Karmanos Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Sukari', 'Affiliation': 'Karmanos Cancer Institute, Department of Oncology, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Nagasaka', 'Affiliation': 'Division of Hematology and Oncology, University of California Irvine School of Medicine, Orange.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2021.2776']
2051,34706963,Immediate versus postponed single blastocyst transfer in modified natural cycle frozen embryo transfer (mNC-FET): a study protocol for a multicentre randomised controlled trial.,"INTRODUCTION


Today, it is widespread practice to postpone frozen embryo transfer (FET) in a modified natural cycle (mNC) for at least one menstrual cycle after oocyte retrieval and failed fresh embryo transfer or freeze-all. The rationale behind this practice is the concern that suboptimal ovarian, endometrial or endocrinological conditions following ovarian stimulation may have a negative impact on endometrial receptivity and implantation. However, two recent systematic reviews and meta-analyses based on retrospective data did not support this practice. As unnecessary delay in time to transfer and pregnancy should be avoided, the aim of this study is to investigate if immediate single blastocyst transfer in mNC-FET is non-inferior to standard postponed single blastocyst transfer in mNC-FET in terms of live birth rate.
METHODS AND ANALYSIS


Multicentre randomised controlled non-blinded trial including 464 normo-ovulatory women aged 18-40 years undergoing single blastocyst mNC-FET after a failed fresh or freeze-all cycle. Participants are randomised 1:1 to either FET in the first menstrual cycle following the stimulated cycle (immediate FET) or FET in the second or subsequent cycle following the stimulated cycle (postponed FET). The study is designed as a non-inferiority trial and primary analyses will be performed as intention to treat and per protocol.
ETHICS AND DISSEMINATION


Ethical approval has been granted by the Scientific Ethical Committee of the Capital Region of Denmark (J-nr.: H-19086300). Data will be handled according to Danish law on personal data protection in accordance with the general data protection regulation. Participants will complete written consent forms regarding participation in the study and storage of blood samples in a biobank for future research. The study will be monitored by a Good Clinical Practice (GCP)-trained study nurse not otherwise involved in the study. The results of this study will be disseminated by publication in international peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER


NCT04748874; Pre-results.",2021,"METHODS AND ANALYSIS


Multicentre randomised controlled non-blinded trial including 464 normo-ovulatory women aged 18-40 years undergoing single blastocyst mNC-FET after a failed fresh or freeze-all cycle.",['464 normo-ovulatory women aged 18-40 years undergoing single blastocyst mNC-FET after a failed fresh or freeze-all cycle'],"['FET', 'Immediate versus postponed single blastocyst transfer in modified natural cycle frozen embryo transfer (mNC-FET']",[],"[{'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}]","[{'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0936221', 'cui_str': 'Blastocyst Transfer'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205296', 'cui_str': 'Natural'}]",[],464.0,0.279065,"METHODS AND ANALYSIS


Multicentre randomised controlled non-blinded trial including 464 normo-ovulatory women aged 18-40 years undergoing single blastocyst mNC-FET after a failed fresh or freeze-all cycle.","[{'ForeName': 'Sara Johanna', 'Initials': 'SJ', 'LastName': 'Bergenheim', 'Affiliation': 'Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark sara.johanna.bergenheim@regionh.dk.'}, {'ForeName': 'Marte', 'Initials': 'M', 'LastName': 'Saupstad', 'Affiliation': 'Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Pistoljevic', 'Affiliation': 'Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lyng Forman', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Elisabeth Clare', 'Initials': 'EC', 'LastName': 'Larsen', 'Affiliation': 'Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jeanette Wulff', 'Initials': 'JW', 'LastName': 'Bogstad', 'Affiliation': 'Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Malene', 'Initials': 'M', 'LastName': 'Fynbo', 'Affiliation': 'Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Hashem', 'Affiliation': 'Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina La Cour', 'Initials': 'NC', 'LastName': 'Freiesleben', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Bugge', 'Initials': 'B', 'LastName': 'Nøhr', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Herlev Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lars Franch', 'Initials': 'LF', 'LastName': 'Andersen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Hillerød Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Humaidan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Skive Regional Hospital, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Ziebe', 'Affiliation': 'Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anja Bisgaard', 'Initials': 'AB', 'LastName': 'Pinborg', 'Affiliation': 'Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'Fertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2021-053234']
2052,34708471,"The efficacy of Lactobacillus acidophilus and rhamnosus in the reduction of bacterial load of Helicobacter pylori and modification of gut microbiota-a double-blind, placebo-controlled, randomized trial.","BACKGROUND


Probiotics may alter the gut microbiota and may reduce antibiotic-related dysbiosis after H. pylori eradication. However, whether probiotics are effective in reducing the bacterial load of H. pylori and modifying the gut microbiota remains unknown. We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in reducing the bacterial load of H. pylori and modifying the gut microbiota.
MATERIALS AND METHODS


In this double-blind, randomized, placebo-controlled trial, we recruited 40 adult subjects with moderate to high bacterial loads of H. pylori, defined as a mean delta over baseline (DOB) value of the  13  C-urea breath test ( 13  C-UBT) of 10 or greater every 4 days 6 times. Eligible subjects were randomized in a 1:1 ratio to receive either probiotics containing Lactobacillus acidophilus and Lactobacillus rhamnosus or placebo twice daily for 4 weeks.  13  C-UBT was measured weekly from the beginning of treatment to 2 weeks after treatment. Amplification of the V3 and V4 hypervariable regions of the 16S rRNA was performed for fecal microbiota.
RESULTS


A total of 40 subjects were randomized to receive probiotics or placebo. The DOB value was significantly lower in the probiotic group than in the placebo group after 4 weeks of treatment (26.0 vs. 18.5, p = .045). The DOB value was significantly reduced compared to that at baseline in the probiotic group (18.5 vs. 26.7, p = .001) but not in the placebo group (26.0 vs. 25.0, p = .648). However, the eradication rate for H. pylori was 0% in both groups. There was no significant difference in the DOB values between the two groups 1 and 2 weeks after discontinuation of the probiotics. There were also no significant changes observed in the α-diversity and β-diversity at week 4 compared to baseline in the probiotic group (p = .77 and 0.91) and the placebo group (p = .26 and 0.67).
CONCLUSIONS


Although the use of Lactobacillus acidophilus and Lactobacillus rhamnosus may reduce the bacterial load of H. pylori, there were no significant changes in the composition of gut microbiota. This trial is registered with ClinicalTrials.gov, NCT02725138.",2021,There was no significant difference in the DOB values between the two groups 1 and 2 weeks after discontinuation of the probiotics.,"['40 adult subjects with moderate to high bacterial loads of H.\xa0pylori, defined as a mean delta over baseline (DOB) value of the  13  C-urea breath test ( 13  C-UBT) of 10 or greater every 4\xa0days 6 times', 'Eligible subjects', 'A total of 40\xa0subjects']","['probiotics containing Lactobacillus acidophilus and Lactobacillus rhamnosus or placebo', 'Lactobacillus acidophilus and Lactobacillus rhamnosus', 'Lactobacillus acidophilus and rhamnosus', 'probiotics or placebo', 'placebo']","['DOB value', 'eradication rate', 'composition of gut microbiota', 'DOB values', 'α-diversity and β-diversity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0729631', 'cui_str': 'Carbon-13'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1275554', 'cui_str': 'Every four days'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",40.0,0.704739,There was no significant difference in the DOB values between the two groups 1 and 2 weeks after discontinuation of the probiotics.,"[{'ForeName': 'Mei-Jyh', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chieh-Chang', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chun', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chieh-Chih', 'Initials': 'CC', 'LastName': 'Tseng', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jing-Ting', 'Initials': 'JT', 'LastName': 'Hsu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yi-Fen', 'Initials': 'YF', 'LastName': 'Lin', 'Affiliation': 'Taiwan Sugar Corporation Biotechnology Business R&D Division, Chia-Yi, Taiwan.'}, {'ForeName': 'Yu-Jen', 'Initials': 'YJ', 'LastName': 'Fang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Ming-Shiang', 'Initials': 'MS', 'LastName': 'Wu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jyh-Ming', 'Initials': 'JM', 'LastName': 'Liou', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Helicobacter,['10.1111/hel.12857']
2053,34708441,Enamel matrix derivative as an adjunct to minimally invasive non-surgical treatment of intrabony defects: A randomized clinical trial.,"AIM


To compare the efficacy of minimally invasive non-surgical technique (MINST) with or without enamel matrix derivative (EMD) in the treatment of intrabony defects ≤7 mm.
MATERIALS AND METHODS


Thirty-six patients were randomly assigned to the two groups. The control group received MINST, while the experimental MINST+EMD. Clinical measurements were recorded at baseline and at 6 and 12 months, and radiographic measurements were made at baseline and 12 months.
RESULTS


All subjects completed the study, 18 in each group. Significant improvements were observed in both groups at 12 months (p < .001) with no differences in mean PD reduction (4.0 ± 1.4 vs. 4.2 ± 1.7 mm), CAL gain (3.5 ± 1.4 vs. 3.4 ± 1.6 mm), and defect resolution (1.9 ± 1.1 vs. 1.8 ± 0.9 mm) for the MINST and the MINST+EMD groups, respectively (p > .05). A trend for greater pocket closure (PD ≤4 mm and no BoP) was achieved with the application of EMD (77.8% vs. 55.6% sites), particularly for sites with baseline PD ≤8 mm (92.3% vs. 69.2% sites), accompanied by an increased number of successful composite outcome results (61.1% vs. 44.4% sites).
CONCLUSIONS


MINST demonstrates significant improvements 12 months after treatment of intrabony defects ≤7 mm. The additional application of EMD does not further improve the mean clinical or radiographic outcomes. This study is registered in ClinicalTrials.gov (NCT03622255).",2021,"Significant improvements were observed in both groups at 12 months (p<0.001) with no differences in mean PD reduction (4.0±1.4 mm vs 4.2±1.7 mm), CAL gain (3.5±1.4 mm vs 3.4±1.6 mm) and defect resolution (","['36 patients', 'Minimally Invasive Non-Surgical Treatment of Intrabony Defects', 'intrabony defects ≤7mm']","['MINST', 'minimally invasive non-surgical technique (MINST) with or without Enamel Matrix Derivative (EMD', 'Enamel Matrix Derivative']","['mean clinical or radiographic outcomes', 'defect resolution ', 'mean PD reduction', 'CAL gain', 'greater pocket closure (PD≤4mm and no BoP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}]",36.0,0.158399,"Significant improvements were observed in both groups at 12 months (p<0.001) with no differences in mean PD reduction (4.0±1.4 mm vs 4.2±1.7 mm), CAL gain (3.5±1.4 mm vs 3.4±1.6 mm) and defect resolution (","[{'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Anoixiadou', 'Affiliation': 'Department of Preventive Dentistry Periodontology and Implant Biology, Faculty of Dentistry, School of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Parashis', 'Affiliation': 'Department of Preventive Dentistry Periodontology and Implant Biology, Faculty of Dentistry, School of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Vouros', 'Affiliation': 'Department of Preventive Dentistry Periodontology and Implant Biology, Faculty of Dentistry, School of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",Journal of clinical periodontology,['10.1111/jcpe.13567']
2054,34695679,General movement optimality score and general movements trajectories following early parent-administrated physiotherapy in the neonatal intensive care unit.,"BACKGROUND


The Prechtl General Movement Assessment (GMA) is a reliable tool for the functional assessment of the young nervous system. It is based on a global assessment of the quality of infants' movements. In addition, detailed steps of assessment have been developed - one for preterm and term age, and one for use between 3 and 5 months. One potential benefit of such a detailed analysis is the documentation of subtle changes in the infants' spontaneous movements caused by early intervention.
AIM


To present detailed scores of the infants' general movements (GMs) at preterm age, and of the infants' motor repertoire at 3 months' postterm age (PTA), for infants having participated in a randomized controlled trial (RCT) of early intervention, and to examine possible group differences. In addition, the aim is also to present the GMA from preterm to 3 months' PTA, comparing the intervention and the control group.
STUDY DESIGN


A retrospective study on infants who had participated in an RCT of parent-administered early intervention.
SUBJECTS


141 infants born very preterm.
OUTCOME MEASURES


GMA, ""Detailed Assessment of General Movements During Preterm and Term Age"" and ""Assessment of Motor Repertoire at 3 to 5 months"".
RESULTS


The GMA and the detailed assessments of GMs conducted at 36 weeks' post menstrual age (PMA) showed the same distribution of normal and abnormal movements in both the intervention and in the control group, as did the assessment of motor repertoire at 3 months' PTA.
CONCLUSION


Neither the GMA nor the detailed assessments of GMs at 36 weeks' PMA and of the motor repertoire at 13 weeks' PTA suggest that early intervention, performed before term, changes the GMs of very preterm-born infants.",2021,"BACKGROUND


The Prechtl General Movement Assessment (GMA) is a reliable tool for the functional assessment of the young nervous system.","[""infants' general movements (GMs) at preterm age, and of the infants' motor repertoire at 3\xa0months' postterm age (PTA), for infants having participated"", '141 infants born very preterm', 'infants who had participated in an RCT of parent-administered early intervention']",[],"['GMA, ""Detailed Assessment of General Movements']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",141.0,0.0594287,"BACKGROUND


The Prechtl General Movement Assessment (GMA) is a reliable tool for the functional assessment of the young nervous system.","[{'ForeName': 'Tordis', 'Initials': 'T', 'LastName': 'Ustad', 'Affiliation': 'Clinic of Clinical Services, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Clinical and Molecular Medicine, Faculty of Medicine and Health sciences, Norwegian University of Science and Technology, Trondheim, Norway. Electronic address: tordis.ustad@ntnu.no.'}, {'ForeName': 'Toril', 'Initials': 'T', 'LastName': 'Fjørtoft', 'Affiliation': 'Clinic of Clinical Services, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Clinical and Molecular Medicine, Faculty of Medicine and Health sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Gunn Kristin', 'Initials': 'GK', 'LastName': 'Øberg', 'Affiliation': 'Department of Health and Care Sciences, University of Tromsø, The Arctic University of Norway, Tromsø, Norway; Section of Physiotherapy, University Hospital North Norway, Tromsø, Norway.'}]",Early human development,['10.1016/j.earlhumdev.2021.105488']
2055,34706171,Efficacy and Safety of Itepekimab in Patients with Moderate-to-Severe Asthma.,"BACKGROUND


Monoclonal antibodies targeting IgE, interleukin-4 and -13, and interleukin-5 are effective in treating severe type 2 asthma, but new targets are needed. Itepekimab is a new monoclonal antibody against the upstream alarmin interleukin-33. The efficacy and safety of itepekimab as monotherapy, as well as in combination with dupilumab, in patients with asthma are unclear.
METHODS


In a phase 2 trial, we randomly assigned, in a 1:1:1:1 ratio, adults with moderate-to-severe asthma receiving inhaled glucocorticoids plus long-acting beta-agonists (LABAs) to receive subcutaneous itepekimab (at a dose of 300 mg), itepekimab plus dupilumab (both at 300 mg; combination therapy), dupilumab (300 mg), or placebo every 2 weeks for 12 weeks. After randomization, LABA was discontinued at week 4, and inhaled glucocorticoids were tapered over weeks 6 through 9. The primary end point was an event indicating a loss of asthma control, assessed in the itepekimab group and the combination group, as compared with the placebo group. Secondary and other end points included lung function, asthma control, quality of life, type 2 biomarkers, and safety.
RESULTS


A total of 296 patients underwent randomization. By 12 weeks, an event indicating a loss of asthma control occurred in 22% of the patients in the itepekimab group, 27% of those in the combination group, and 19% of those in the dupilumab group, as compared with 41% of those in the placebo group; the corresponding odds ratios as compared with placebo were as follows: in the itepekimab group, 0.42 (95% confidence interval [CI], 0.20 to 0.88; P = 0.02); in the combination group, 0.52 (95% CI, 0.26 to 1.06; P = 0.07); and in the dupilumab group, 0.33 (95% CI, 0.15 to 0.70). As compared with placebo, the forced expiratory volume in 1 second before bronchodilator use increased with the itepekimab and dupilumab monotherapies but not with the combination therapy. Itepekimab treatment improved asthma control and quality of life, as compared with placebo, and led to a greater reduction in the mean blood eosinophil count. The incidence of adverse events was similar in all four trial groups.
CONCLUSIONS


Interleukin-33 blockade with itepekimab led to a lower incidence of events indicating a loss of asthma control than placebo and improved lung function in patients with moderate-to-severe asthma. (Funded by Sanofi and Regeneron Pharmaceuticals; ClinicalTrials.gov number, NCT03387852.).",2021,"As compared with placebo, the forced expiratory volume in 1 second before bronchodilator use increased with the itepekimab and dupilumab monotherapies but not with the combination therapy.","['Patients with Moderate-to-Severe Asthma', 'patients with moderate-to-severe asthma', 'patients with asthma are unclear', 'adults with moderate-to-severe asthma receiving', '296 patients underwent randomization']","['LABA', 'inhaled glucocorticoids plus long-acting beta-agonists (LABAs) to receive subcutaneous itepekimab', 'itepekimab plus dupilumab (both at 300 mg; combination therapy), dupilumab (300 mg), or placebo', 'inhaled glucocorticoids', 'placebo', 'itepekimab', 'Itepekimab']","['lung function, asthma control, quality of life, type 2 biomarkers, and safety', 'mean blood eosinophil count', 'Efficacy and Safety', 'adverse events', 'loss of asthma control', 'forced expiratory volume', 'efficacy and safety', 'asthma control and quality of life', 'lung function', 'event indicating a loss of asthma control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]",296.0,0.343353,"As compared with placebo, the forced expiratory volume in 1 second before bronchodilator use increased with the itepekimab and dupilumab monotherapies but not with the combination therapy.","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Marcella K', 'Initials': 'MK', 'LastName': 'Ruddy', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Ford', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Jorge F', 'Initials': 'JF', 'LastName': 'Maspero', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Raolat M', 'Initials': 'RM', 'LastName': 'Abdulai', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Chih-Chi', 'Initials': 'CC', 'LastName': 'Hu', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Martincova', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jessel', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Nivens', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Goulaouic', 'Affiliation': ""From the Department of Medicine, National Jewish Health, Denver (M.E.W.); Regeneron Pharmaceuticals, Tarrytown, NY (M.K.R., M.C.N., N.A., D.M.W., G.D.Y.); NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (I.D.P.); Harvard Medical School and Brigham and Women's Hospital, Boston (E.I.); the Department of Medicine, Christian Albrechts University Kiel, Kiel, and LungenClinic Grosshansdorf and the Airway Research Center North at the German Center for Lung Research, Grosshansdorf - all in Germany (K.F.R.); the Asthma and Allergy Center, Bellevue, NE (L.B.F.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.F.M.); Sanofi, Cambridge, MA (R.M.A.); Sanofi, Bridgewater, NJ (C.-C.H., A.J.); Sanofi, Prague, Czech Republic (R.M.); and Sanofi, Chilly-Mazarin, France (H.G.).""}]",The New England journal of medicine,['10.1056/NEJMoa2024257']
2056,34706949,Response to cardiac resynchronisation therapy in men and women: a secondary analysis of the SMART-AV randomised controlled trial.,"OBJECTIVES


There is a controversy about whether both sexes' response to cardiac resynchronisation therapy (CRT) is similar. We aimed to assess a causal effect of sex on CRT response.
DESIGN


Secondary analysis of a randomised controlled trial (RCT) data. Doubly robust augmented-inverse-probability-weighted (AIPW) estimation of sex effect on CRT response.
SETTING


The SmartDelay Determined Atrioventricular (AV) Optimisation (SMART-AV) RCT.
PARTICIPANTS


The SMART-AV RCT enrolled New York Heart Association class III-IV patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≤35% despite optimal medical therapy and QRS duration ≥120 ms, in sinus rhythm. After exclusion of those with missing outcome or covariates, 741 participants (age 66±11 years; 33% female; 78% white; LVEF 28%±9%; 58% ischaemic cardiomyopathy; 75% left bundle branch block; left ventricular end-systolic volume index (LVESVI) 65±30 mL/m 2 ) were included.
INTERVENTIONS


Implanted CRT defibrillator with randomly assigned AV delay as either (1) fixed at 120 ms, or (2) echocardiography-determined, or (3) SmartDelay algorithm-programmed.
OUTCOME


A composite of freedom from death and HF hospitalisation and a >15% reduction in LVESVI at 6 month post-CRT was the endpoint.
RESULTS


The primary endpoint was met by 337 patients (45.5%); 134 were women (55.6% response) and 203 were men (40.6% response); p<0.0001. After conditioning for 33 covariates that included baseline demographic, clinical, ECG, echocardiographic and biomarker characteristics, known predictors of CRT response, logistic regression showed a higher probability for composite CRT response for women versus men (OR 1.79; 95% CI 1.08 to 2.98; p<0.0001), whereas AIPW estimation showed no difference in CRT response (average treatment effect 0.88; 95% CI 0.41 to 1.89; p=0.739). After removing colliders from the model, both logistic regression (OR 1.00; 95% CI 0.69 to 1.44) and AIPW (ATE 1.06; 95% CI 0.96 to 1.16) reported similar results.
CONCLUSIONS


Both sexes' response to CRT is similar. Sex differences in HF substrate, treatment and comorbidities explain sex disparities in CRT outcomes.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Identifier; NCT00677014.",2021,"After removing colliders from the model, both logistic regression (OR 1.00; 95% CI 0.69 to 1.44) and AIPW (ATE 1.06; 95% CI 0.96 to 1.16) reported similar results.
","['men and women', '741 participants (age 66±11 years; 33% female; 78% white; LVEF 28%±9%; 58% ischaemic cardiomyopathy; 75% left bundle branch block; left ventricular end-systolic volume index (LVESVI) 65±30', 'The SMART-AV RCT enrolled New York Heart Association class III-IV patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≤35% despite optimal medical therapy and QRS duration ≥120 ms, in sinus rhythm']","['cardiac resynchronisation therapy (CRT', 'cardiac resynchronisation therapy', 'Implanted CRT defibrillator with randomly assigned AV delay as either (1) fixed at 120 ms, or (2) echocardiography-determined, or (3) SmartDelay algorithm-programmed']","['CRT response', 'inverse-probability-weighted (AIPW) estimation of sex effect on CRT response', 'composite CRT response', 'LVESVI']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0023211', 'cui_str': 'Left bundle branch block'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0429025', 'cui_str': 'QRS complex duration'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",741.0,0.199428,"After removing colliders from the model, both logistic regression (OR 1.00; 95% CI 0.69 to 1.44) and AIPW (ATE 1.06; 95% CI 0.96 to 1.16) reported similar results.
","[{'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'Department of Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Stivland', 'Affiliation': 'Boston Scientific Corp, Marlborough, Massachusetts, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Stein', 'Affiliation': 'Boston Scientific Corp, Marlborough, Massachusetts, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ellenbogen', 'Affiliation': 'Department of Medicine, Medical College of Virginia, Richmond, Virginia, USA.'}, {'ForeName': 'Larisa G', 'Initials': 'LG', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA tereshch@ohsu.edu.'}]",BMJ open,['10.1136/bmjopen-2021-049017']
2057,34708422,Peri-implant tissue changes at sites treated with alveolar ridge preservation in the aesthetic zone: Twenty-two months follow-up of a randomized clinical trial.,"AIM


To compare tissue changes at implant sites previously treated with two biomaterials for alveolar ridge preservation (ARP) in the aesthetic zone, 1 year after restoration.
MATERIALS AND METHODS


Sixty-six participants were treated with ARP using demineralized bovine bone mineral (DBBM) or DBBM +10% of collagen (DBBM-C), both covered with a collagen matrix (CM). Dental implants were placed, and definitive crowns were installed. Silicon impressions were taken before tooth extraction (T0), 2 weeks after crown insertion (T1) and 1 year after restoration (T2). Mid-facial mucosal level change (MLC), soft tissue thickness changes (TT), and marginal bone loss (MBL) were analysed using inter-group comparisons.
RESULTS


Fifty-four participants were included in the analysis. The mid-facial level change between T0-T1 and T1-T2 showed no statistical difference between DBBM and DBBM-C. Between T0 and T1 for soft tissue thickness, DBBM performed significantly better at 3 and 5 mm below the mucosal margin. From T1 to T2, no significant differences between groups were found at any level for soft tissue thickness and MBL.
CONCLUSION


At the aesthetic zone, advanced recession from tooth extraction to crown placement can be expected at sites treated with ARP regardless of biomaterial used. However, after crown insertion, tissue stability can be predicted.",2021,"From T1 to T2, no significant differences between groups were found at any level for soft tissue thickness and MBL.
","['Sixty-six participants were treated with', 'Fifty-four participants were included for analysis', 'esthetic zone']","['two biomaterials for alveolar ridge preservation (ARP', 'ARP using demineralized bovine bone mineral (DBBM) or DBBM + 10% of collagen (DBBM-C) both covered with a collagen matrix (CM']","['soft tissue thickness and MBL', 'Mid-facial mucosal level change (MLC), soft tissue thickness changes (TT), and marginal bone loss (MBL', 'tissue stability']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]","[{'cui': 'C0005479', 'cui_str': 'Biomaterials'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",66.0,0.100446,"From T1 to T2, no significant differences between groups were found at any level for soft tissue thickness and MBL.
","[{'ForeName': 'Carlos Guillermo Benítez', 'Initials': 'CGB', 'LastName': 'Silva', 'Affiliation': 'Discipline of Periodontics, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vitor Marques', 'Initials': 'VM', 'LastName': 'Sapata', 'Affiliation': 'Discipline of Periodontics, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexandre Hugo', 'Initials': 'AH', 'LastName': 'Llanos', 'Affiliation': 'Discipline of Periodontics, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Munhoes', 'Initials': 'MM', 'LastName': 'Romano', 'Affiliation': 'Multidisciplinary Clinic Division, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ronald Ernst', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christoph Hans Franz', 'Initials': 'CHF', 'LastName': 'Hämmerle', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'João Batista', 'Initials': 'JB', 'LastName': 'Cesar-Neto', 'Affiliation': 'Discipline of Periodontics, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cláudio Mendes', 'Initials': 'CM', 'LastName': 'Pannuti', 'Affiliation': 'Discipline of Periodontics, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Giuseppe Alexandre', 'Initials': 'GA', 'LastName': 'Romito', 'Affiliation': 'Discipline of Periodontics, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}]",Journal of clinical periodontology,['10.1111/jcpe.13570']
2058,34709365,Feasibility of a Risk-Based Approach to Cataract Surgery Preoperative Medical Evaluation.,"Importance


In 2019, the US Centers for Medicare & Medicaid Services implemented the Patients Over Paperwork initiative, allowing hospitals and ambulatory surgery centers to establish their own policies on preoperative history and physical requirements. A risk-based approach to preoperative medical evaluation may allow surgeons to provide high-value patient care.
Objective


To assess the feasibility of a risk-based approach to cataract surgery preoperative medical evaluation through a lens of safety and throughput.
Design, Setting, and Participants


A pilot study was performed to evaluate the implementation of a risk-based approach to preoperative medical evaluation for cataract surgery using a virtual medical history questionnaire. The intervention group, seen from June to September 2020, received the risk assessment and those who were low risk proceeded to surgery without further preoperative evaluation prior to the day of surgery. The preintervention control group included patients who received standard care from January to December 2019.
Main Outcomes and Measures


Primary outcomes included rates of intraoperative complications, noneye-related emergency department visits within 7 days, inpatient admissions within 7 days of surgery, case delays, and rates of case cancellation. The secondary outcome included patient perception regarding preoperative care.
Results


A total of 1095 patients undergoing cataract surgery were included in the intervention group (1813 [58.2%] female) and 3114 were in the control group (621/1095 [56.7%] female). The mean (SD) age was 68.6 (11.0) in the control group and 68.4 (10.5) in the intervention group. The intervention group included 126 low-risk individuals (11.5%) and 969 individuals who received standard care (88.5%). There were no differences between the control and intervention groups in terms of rates of intraoperative complications (control group vs intervention group: 21 [0.7%] vs 3 [0.3%]; difference, -0.4% [95% CI, -0.82 to 0.02]), 7-day noneye-related ED visits (5 [0.2%] vs 3 [0.3%]; difference, 0.1% [95% CI, -0.23 to 0.45]), 7-day inpatient admissions (6 [0.2%] vs 2 [0.2%]; difference, -0.01% [95% CI, -0.31 to 0.29]), or same-day cancellations (31 [0.8%] vs 10 [0.6%]; difference, -0.15% [95% CI, -0.63 to 0.34]). The control group had more case delays (59 [1.9%] vs 7 [0.6%]; difference, -1.3% [95% CI, -1.93 to -0.58]).
Conclusions and Relevance


This study suggests that a virtual, risk-based approach to preoperative medical evaluations for cataract surgery is associated with safe and efficient outcomes. These findings may encourage health care systems and ambulatory surgery centers to tailor preoperative requirements for low-risk surgery patients.",2021,"There were no differences between the control and intervention groups in terms of rates of intraoperative complications (control group vs intervention group: 21 [0.7%] vs 3 [0.3%]; difference, -0.4% [95% CI, -0.82 to 0.02]), 7-day noneye-related ED visits (5 [0.2%] vs 3 [0.3%]; difference, 0.1% [95% CI, -0.23 to 0.45]), 7-day inpatient admissions (6 [0.2%] vs 2 [0.2%]; difference, -0.01% [95% CI, -0.31 to 0.29]), or same-day cancellations (31 [0.8%] vs 10 [0.6%]; difference, -0.15% [95% CI, -0.63 to 0.34]).","['patients who received standard care from January to December 2019', '1095 patients undergoing cataract surgery were included in the intervention group (1813 [58.2%] female) and 3114 were in the control group (621/1095 [56.7%] female', '126 low-risk individuals (11.5%) and 969 individuals who received standard care (88.5', 'low-risk surgery patients']","['risk-based approach to preoperative medical evaluation for cataract surgery using a virtual medical history questionnaire', 'Risk-Based Approach to Cataract Surgery Preoperative Medical Evaluation', 'risk-based approach to cataract surgery preoperative medical evaluation']","['rates of intraoperative complications', 'rates of intraoperative complications, noneye-related emergency department visits within 7 days, inpatient admissions within 7 days of surgery, case delays, and rates of case cancellation', '7-day noneye-related ED visits', 'case delays', '7-day inpatient admissions', 'patient perception regarding preoperative care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033061', 'cui_str': 'Preoperative care'}]",1095.0,0.145553,"There were no differences between the control and intervention groups in terms of rates of intraoperative complications (control group vs intervention group: 21 [0.7%] vs 3 [0.3%]; difference, -0.4% [95% CI, -0.82 to 0.02]), 7-day noneye-related ED visits (5 [0.2%] vs 3 [0.3%]; difference, 0.1% [95% CI, -0.23 to 0.45]), 7-day inpatient admissions (6 [0.2%] vs 2 [0.2%]; difference, -0.01% [95% CI, -0.31 to 0.29]), or same-day cancellations (31 [0.8%] vs 10 [0.6%]; difference, -0.15% [95% CI, -0.63 to 0.34]).","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Cuttitta', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, University of Michigan Health, Ann Arbor.'}, {'ForeName': 'Shannon S', 'Initials': 'SS', 'LastName': 'Joseph', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, University of Michigan Health, Ann Arbor.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Michigan Program on Value Enhancement (MPrOVE), University of Michigan Health, Ann Arbor.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Portney', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, University of Michigan Health, Ann Arbor.'}, {'ForeName': 'Jenna M', 'Initials': 'JM', 'LastName': 'Keedy', 'Affiliation': 'Michigan Program on Value Enhancement (MPrOVE), University of Michigan Health, Ann Arbor.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Benedict', 'Affiliation': 'Michigan Program on Value Enhancement (MPrOVE), University of Michigan Health, Ann Arbor.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Lahti', 'Affiliation': 'Michigan Program on Value Enhancement (MPrOVE), University of Michigan Health, Ann Arbor.'}, {'ForeName': 'Pattricia S', 'Initials': 'PS', 'LastName': 'Klarr', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor.'}, {'ForeName': 'Roni M', 'Initials': 'RM', 'LastName': 'Shtein', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, University of Michigan Health, Ann Arbor.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, University of Michigan Health, Ann Arbor.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Kerr', 'Affiliation': 'Michigan Program on Value Enhancement (MPrOVE), University of Michigan Health, Ann Arbor.'}, {'ForeName': 'Shahzad I', 'Initials': 'SI', 'LastName': 'Mian', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, University of Michigan Health, Ann Arbor.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2021.4393']
2059,34670156,Photodynamic therapy and gaseous ozone versus conventional post space treatment methods on the push-out bond strength of fiber posts luting with different resin cements.,"BACKGROUND


The aim of this study was to compare the push-out bond strength of fiber posts by using two different resin cement after the treatments of post space with photodynamic therapy, gaseous ozone and conventional disinfection solution.
METHODS


The root canal treatments of one hundred maxillary incisors were performed. The roots were randomly distributed into 5 groups (n = 20). NaOCl of 2.5% + EDTA of 17% in group 1, CHX of 2% in group 2, toluidine blue + diode laser as the photodynamic therapy (PDT) in group 3 and ozone in group 4 were applied to the post spaces. Group 5 was washed with distilled water as control group. Each group was divided into two subgroups according to the adhesive types and the posts were bonded by using RelyX and LinkForce. The bond strength was calculated using the push-out test method. Resin tag formations were photographed with SEM. The push-out bond strength was analyzed by ANOVA and Tukey tests (p = .05).
RESULTS


The PDT group, which showed the highest PBS among the groups bonded with LinkForce at all levels, was significantly higher than Ozone and DW groups (p<.05). NaOCl and ozone treatments provided the highest PBS among the groups bonded with RelyX for all levels and this difference was significant according to the DW group (p < .05).
CONCLUSION


Post space treatments improved the bond strength of the fiber post ​​in both types of resin cement.",2021,"NaOCl and ozone treatments provided the highest PBS among the groups bonded with RelyX for all levels and this difference was significant according to the DW group (p < .05).
",['fiber posts luting with different resin cements'],"['Photodynamic therapy and gaseous ozone', 'toluidine blue\xa0+\xa0diode laser as the photodynamic therapy (PDT', 'photodynamic therapy, gaseous ozone and conventional disinfection solution']","['highest PBS', 'bond strength']","[{'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0040380', 'cui_str': 'Tolonium chloride'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",100.0,0.0259679,"NaOCl and ozone treatments provided the highest PBS among the groups bonded with RelyX for all levels and this difference was significant according to the DW group (p < .05).
","[{'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Küden', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cukurova University, Adana, 01380, Turkey. Electronic address: ckuden@cu.edu.tr.'}, {'ForeName': 'Seda Nur', 'Initials': 'SN', 'LastName': 'Karakaş', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Cukurova University, Adana, 01380, Turkey. Electronic address: skarakas@cu.edu.tr.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102586']
2060,34713987,"Population pharmacokinetic-pharmacodynamic modeling of PB2452, a monoclonal antibody fragment being developed as a ticagrelor reversal agent, in healthy volunteers.","PB2452, a neutralizing monoclonal antibody fragment that binds the antiplatelet drug ticagrelor with high affinity, is being developed as a ticagrelor reversal agent. To identify a clinically useful intravenous (i.v.) reversal regimen, a semimechanistic exposure-response model was developed during the PB2452 first-in-human phase I study. From a randomized, double-blind, placebo-controlled, single-dose trial to evaluate the safety, efficacy, and pharmacokinetics (PKs) of PB2452 in 61 healthy volunteers pretreated with ticagrelor, sequential dose cohort data were used to build and refine an exposure-response model that combined population PK models for ticagrelor (TICA), ticagrelor active metabolite (TAM), and PB2452, and related their binding relationships to the PK of uncomplexed TICA and TAM which is predictive of platelet inhibition. Platelet function was assessed by multiple assays. The model was developed using Bayesian methods in NONMEM. Human PK and pharmacodynamic data from sequential dose cohorts were used to initially define and then refine model parameters. Model simulations indicated that an initial i.v. bolus of PB2452, followed by a high-rate infusion, and then a slower-rate infusion would provide immediate and sustained reversal of the antiplatelet effects of ticagrelor. Based on model predictions, a 6 g i.v. bolus followed by 6 g infused over 4 h and then 6 g over 12 h was identified and tested in study subjects and shown to provide complete reversal within 5 min of infusion onset that was sustained for 20-24 h. The model is predictive of the reversal profile of PB2452 and will inform future trials of PB2452.",2021,"PB2452, a neutralizing monoclonal antibody fragment that binds the antiplatelet drug ticagrelor with high affinity, is being developed as a ticagrelor reversal agent.","['61 healthy volunteers pretreated with', 'Healthy Volunteers']","['ticagrelor (TICA), ticagrelor active metabolite (TAM', 'placebo', 'ticagrelor']",['Platelet function'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}]",61.0,0.0614442,"PB2452, a neutralizing monoclonal antibody fragment that binds the antiplatelet drug ticagrelor with high affinity, is being developed as a ticagrelor reversal agent.","[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Kathman', 'Affiliation': 'PPD, Wilmington, North Carolina, USA.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Wheeler', 'Affiliation': 'PPD, Wilmington, North Carolina, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Arnold', 'Affiliation': 'PhaseBio Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'PhaseBio Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.'}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12734']
2061,34709601,Avatrombopag: A Review in Thrombocytopenia.,"Avatrombopag (Doptelet ® ) is an orally administered second generation thrombopoietin receptor agonist (TPO-RA) approved for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory or have an unsatisfactory response to other treatments, as well as for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled to undergo an invasive procedure. In phase III studies, avatrombopag was associated with a significantly greater platelet response than placebo in patients with chronic ITP, and was superior to placebo in reducing the requirement for platelet transfusion or rescue procedures for bleeding caused by surgery in patients with CLD with a platelet count < 50 × 10 9 /L at baseline. Longer term data indicate that avatrombopag is associated with high durable response rates in ITP and may have corticosteroid-sparing effects. The drug was generally well tolerated in both indications. Avatrombopag thus represents a convenient and effective second-line treatment for patients with chronic ITP and can prevent bleeding events in patients with CLD scheduled to undergo a procedure, offering a useful alternative to other available treatments in both indications.",2021,"In phase III studies, avatrombopag was associated with a significantly greater platelet response than placebo in patients with chronic ITP, and was superior to placebo in reducing the requirement for platelet transfusion or rescue procedures for bleeding caused by surgery in patients with CLD with a platelet count < 50 ","['patients with CLD with a platelet count <\xa050', 'patients with chronic ITP', 'adult patients with chronic liver disease (CLD) scheduled to undergo an invasive procedure']","['thrombopoietin receptor agonist (TPO-RA', 'placebo', 'Avatrombopag (Doptelet ® ']","['bleeding events', 'platelet response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C2584967', 'cui_str': 'Thrombopoietin receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3886460', 'cui_str': 'avatrombopag'}, {'cui': 'C4694261', 'cui_str': 'Doptelet'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}]",,0.0821451,"In phase III studies, avatrombopag was associated with a significantly greater platelet response than placebo in patients with chronic ITP, and was superior to placebo in reducing the requirement for platelet transfusion or rescue procedures for bleeding caused by surgery in patients with CLD with a platelet count < 50 ","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Markham', 'Affiliation': 'Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]",Drugs,['10.1007/s40265-021-01613-y']
2062,34709582,"Effects of Dapagliflozin Compared with Sitagliptin and Metformin in Drug-Naïve Japanese Patients with Type 2 Diabetes: A 12-Week, Open-Label, Randomized, Active-Controlled Trial.","INTRODUCTION


To compare the efficacy and tolerability of dapagliflozin with those of sitagliptin and metformin in patients with type 2 diabetes who have never received glucose-lowering agents.
METHODS


In this randomized, 12-week, open-label, active-controlled trial, 32 patients were randomly assigned to receive dapagliflozin 5 mg, sitagliptin 50 mg, or metformin 1000 mg per day for 12 weeks. At baseline and at week 12, the patients underwent a meal tolerance test (MTT).
RESULTS


After 12 weeks of treatment, the changes in fasting and postprandial plasma glucose and plasma glucose area under the curve (AUC) 0-120 min  levels during the MTT from baseline were significantly improved in the three study groups, and there were no significant differences among the three study groups (P < 0.05). The mean changes in glycated hemoglobin (HbA1c) from baseline to week 12 were - 0.96%, - 1.24%, and - 1.40% in the dapagliflozin, sitagliptin, and metformin groups, respectively. Although there was no significant difference among the three study groups, the lowering effect of HbA1c tended to be greater in the metformin group than in the dapagliflozin group. In contrast, the insulin AUC 0-120 min  levels at week 12 significantly decreased only in the dapagliflozin group (P = 0.049). Similarly, body weight was significantly reduced only in the dapagliflozin group (- 2.1 kg [- 2.7%], P = 0.047). Moreover, dapagliflozin significantly improved serum adiponectin levels (P = 0.003). However, there were no significant differences in the changes in these glycemic and metabolic parameters among the three study groups. No serious adverse events were documented in any group.
CONCLUSIONS


Dapagliflozin exerted beneficial effects similar to sitagliptin and metformin on glycemic parameters. In addition, dapagliflozin significantly reduced body weight and insulin AUC levels and improved serum adiponectin levels. Therefore, we suggest that these three hypoglycemic agents could be viable first-line medications for drug-naïve Japanese patients with type 2 diabetes.
TRIAL REGISTRATION


University Hospital Medical Information Network (UMIN000024427).",2021,"The mean changes in glycated hemoglobin (HbA1c) from baseline to week 12 were - 0.96%, - 1.24%, and - 1.40% in the dapagliflozin, sitagliptin, and metformin groups, respectively.","['patients with type 2 diabetes who have never received glucose-lowering agents', 'Drug-Naïve Japanese Patients with Type 2 Diabetes', 'naïve Japanese patients with type 2 diabetes', '32 patients']","['dapagliflozin', 'Sitagliptin and Metformin', 'dapagliflozin 5\xa0mg, sitagliptin 50\xa0mg, or metformin', 'sitagliptin and metformin', 'meal tolerance test (MTT', 'Dapagliflozin', 'metformin']","['efficacy and tolerability', 'insulin AUC 0-120\xa0min  levels', 'lowering effect of HbA1c', 'glycemic and metabolic parameters', 'body weight', 'body weight and insulin AUC levels', 'serum adiponectin levels', 'glycemic parameters', 'glycated hemoglobin (HbA1c', 'serious adverse events', 'changes in fasting and postprandial plasma glucose and plasma glucose area under the curve (AUC) 0-120\xa0min  levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3709923', 'cui_str': 'dapagliflozin 5 MG'}, {'cui': 'C1812990', 'cui_str': 'sitagliptin 50 MG'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",32.0,0.0335746,"The mean changes in glycated hemoglobin (HbA1c) from baseline to week 12 were - 0.96%, - 1.24%, and - 1.40% in the dapagliflozin, sitagliptin, and metformin groups, respectively.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ito', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University, 38, Morohongo, Moroyama, Iruma-gun, Saitama, 350-0495, Japan. dito@saitama-med.ac.jp.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University, 38, Morohongo, Moroyama, Iruma-gun, Saitama, 350-0495, Japan.'}, {'ForeName': 'Daigo', 'Initials': 'D', 'LastName': 'Saito', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University, 38, Morohongo, Moroyama, Iruma-gun, Saitama, 350-0495, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Nursing, Ogawa Red Cross Hospital, Saitama, Japan.'}, {'ForeName': 'Kimie', 'Initials': 'K', 'LastName': 'Kaneko', 'Affiliation': 'Department of Nursing, Ogawa Red Cross Hospital, Saitama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sumita', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University, 38, Morohongo, Moroyama, Iruma-gun, Saitama, 350-0495, Japan.'}, {'ForeName': 'Kouichi', 'Initials': 'K', 'LastName': 'Inukai', 'Affiliation': 'Department of Diabetes and Endocrinology, Higashiyamato Hospital, Tokyo, Japan.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Inoue', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University, 38, Morohongo, Moroyama, Iruma-gun, Saitama, 350-0495, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shimada', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University, 38, Morohongo, Moroyama, Iruma-gun, Saitama, 350-0495, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-021-01176-x']
2063,34694201,Improvement in executive function for older adults through smartphone apps: a randomized clinical trial comparing language learning and brain training.,"Bilingualism has been linked to improved executive function and delayed onset of dementia, but it is unknown whether similar benefits can be obtained later in life through deliberate intervention. Given the logistical hurdles of second language acquisition in a randomized trial for older adults, few interventional studies have been done thus far. However, recently developed smartphone apps offer a convenient means to acquire skills in a second language and can be compared with brain training apps specifically designed to improve executive function. In a randomized clinical trial, 76 adults aged 65-75 were assigned to either 16 weeks of Spanish learning using the app Duolingo 30 minutes a day, an equivalent amount of brain training using the app BrainHQ, or a waitlist control condition. Executive function was assessed before and after the intervention with preregistered (NCT03638882) tests previously linked to better performance in bilinguals. For two of the primary measures: incongruent Stroop color naming and 2-back accuracy, Duolingo provided equivalent benefits as BrainHQ compared to a control group. On reaction time for N-back and Simon tests, the BrainHQ group alone experienced strong gains over the other two groups. Duolingo was rated as more enjoyable. These results suggest that app-based language learning may provide some similar benefits as brain training in improving executive function in seniors but has less impact on processing speed. However, future advancements in app design may optimize not only the acquisition of the target language but also the side benefits of the language learning experience.",2021,"On reaction time for N-back and Simon tests, the BrainHQ group alone experienced strong gains over the other two groups.","['older adults through smartphone apps', '76 adults aged 65-75', 'older adults']","['Spanish learning using the app Duolingo 30\xa0minutes a day, an equivalent amount of brain training using the app BrainHQ, or a waitlist control condition', 'language learning and brain training']","['Stroop color naming and 2-back accuracy, Duolingo provided equivalent benefits as BrainHQ', 'Executive function', 'executive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",76.0,0.0971726,"On reaction time for N-back and Simon tests, the BrainHQ group alone experienced strong gains over the other two groups.","[{'ForeName': 'Jed A', 'Initials': 'JA', 'LastName': 'Meltzer', 'Affiliation': 'Baycrest Health Sciences, Rotman Research Institute, Toronto ON, Canada.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Kates Rose', 'Affiliation': 'Baycrest Health Sciences, Rotman Research Institute, Toronto ON, Canada.'}, {'ForeName': 'Anna Y', 'Initials': 'AY', 'LastName': 'Le', 'Affiliation': 'Baycrest Health Sciences, Rotman Research Institute, Toronto ON, Canada.'}, {'ForeName': 'Kiah A', 'Initials': 'KA', 'LastName': 'Spencer', 'Affiliation': 'Baycrest Health Sciences, Rotman Research Institute, Toronto ON, Canada.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Goldstein', 'Affiliation': 'Baycrest Health Sciences, Rotman Research Institute, Toronto ON, Canada.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Gubanova', 'Affiliation': 'Baycrest Health Sciences, Rotman Research Institute, Toronto ON, Canada.'}, {'ForeName': 'Abbie C', 'Initials': 'AC', 'LastName': 'Lai', 'Affiliation': 'Baycrest Health Sciences, Rotman Research Institute, Toronto ON, Canada.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Yossofzai', 'Affiliation': 'Baycrest Health Sciences, Rotman Research Institute, Toronto ON, Canada.'}, {'ForeName': 'Sabrina E M', 'Initials': 'SEM', 'LastName': 'Armstrong', 'Affiliation': 'Baycrest Health Sciences, Rotman Research Institute, Toronto ON, Canada.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bialystok', 'Affiliation': 'Baycrest Health Sciences, Rotman Research Institute, Toronto ON, Canada.'}]","Neuropsychology, development, and cognition. Section B, Aging, neuropsychology and cognition",['10.1080/13825585.2021.1991262']
2064,34706172,"Risankizumab in Severe Asthma - A Phase 2a, Placebo-Controlled Trial.","BACKGROUND


Interleukin-23 has been implicated in airway inflammation that is mediated by type 2 and type 17 cytokines. Whether targeting interleukin-23 in the treatment of asthma improves disease control and reduces airway inflammation is unclear.
METHODS


We conducted a phase 2a, multicenter, randomized, double-blind, placebo-controlled, 24-week, parallel-group trial to assess the efficacy and safety of risankizumab, an anti-interleukin-23p19 monoclonal antibody, in adults with severe asthma. Patients were assigned to receive 90 mg of risankizumab or placebo, administered subcutaneously once every 4 weeks. The primary end point was the time to the first asthma worsening. Asthma worsening was defined as deterioration from baseline on 2 or more consecutive days; deterioration was considered to be a decrease of at least 30% in the morning peak expiratory flow or an increase from baseline of at least 50% in the number of puffs of rescue medication in a 24-hour period (equating to at least four additional puffs), a severe asthma exacerbation, or an increase of 0.75 or more points on the 5-item Asthma Control Questionnaire (ACQ-5; scores range from 0 to 6, with higher scores indicating less control). Secondary end points were the annualized rate of asthma worsening, the annualized rate of severe exacerbations, the ACQ-5 score, and the forced expiratory volume in 1 second. Exploratory end points were assessed with the use of sputum cytologic analysis and gene expression analysis, and safety was assessed.
RESULTS


A total of 105 patients received risankizumab and 109 received placebo. The clinical characteristics of the patients were similar in the two groups. The time to the first asthma worsening was shorter with risankizumab than with placebo (median, 40 days vs. 86 days; hazard ratio, 1.46; 95% confidence interval [CI], 1.05 to 2.04; P = 0.03). The rate ratio for annualized asthma worsening with risankizumab as compared with placebo was 1.49 (95% CI, 1.12 to 1.99), and the rate ratio for severe exacerbations was 1.13 (95% CI, 0.75 to 1.70). Sputum transcriptomic pathway analysis showed that genes involved in the activation of natural killer cells and cytotoxic T cells and the activation of the type 1 helper T and type 17 helper T transcription factors were down-regulated by risankizumab. No safety concerns were associated with risankizumab therapy.
CONCLUSIONS


Risankizumab treatment was not beneficial in severe asthma. The time to the first asthma worsening was shorter and the annualized rate of asthma worsening was higher with risankizumab than with placebo. (Funded by AbbVie and Boehringer Ingelheim; ClinicalTrials.gov number, NCT02443298.).",2021,The time to the first asthma worsening was shorter and the annualized rate of asthma worsening was higher with risankizumab than with placebo.,"['adults with severe asthma', '105 patients received']","['risankizumab', 'Placebo', 'placebo', 'Risankizumab', 'risankizumab or placebo']","['annualized rate of asthma worsening', 'activation of natural killer cells and cytotoxic T cells', 'sputum cytologic analysis and gene expression analysis, and safety', 'rate ratio for severe exacerbations', '5-item Asthma Control Questionnaire (ACQ-5; scores range', 'annualized rate of asthma worsening, the annualized rate of severe exacerbations, the ACQ-5 score, and the forced expiratory volume in 1 second', 'severe asthma exacerbation', 'efficacy and safety', 'time to the first asthma worsening', 'rate ratio for annualized asthma worsening']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",105.0,0.704511,The time to the first asthma worsening was shorter and the annualized rate of asthma worsening was higher with risankizumab than with placebo.,"[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Brightling', 'Affiliation': ""From the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, Department of Respiratory Sciences, University of Leicester, Leicester (C.E.B., D.J.C.), and the University of Manchester, Manchester University NHS Foundation Trust, Manchester (D.S.) - both in the United Kingdom; the Firestone Institute for Respiratory Health, McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (P.N.); and the GIGA-I3 Research Unit, University of Liege, Department of Pneumology, Centre Hospitalier Universitaire Liège, Liege, Belgium (R.L.).""}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Nair', 'Affiliation': ""From the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, Department of Respiratory Sciences, University of Leicester, Leicester (C.E.B., D.J.C.), and the University of Manchester, Manchester University NHS Foundation Trust, Manchester (D.S.) - both in the United Kingdom; the Firestone Institute for Respiratory Health, McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (P.N.); and the GIGA-I3 Research Unit, University of Liege, Department of Pneumology, Centre Hospitalier Universitaire Liège, Liege, Belgium (R.L.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cousins', 'Affiliation': ""From the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, Department of Respiratory Sciences, University of Leicester, Leicester (C.E.B., D.J.C.), and the University of Manchester, Manchester University NHS Foundation Trust, Manchester (D.S.) - both in the United Kingdom; the Firestone Institute for Respiratory Health, McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (P.N.); and the GIGA-I3 Research Unit, University of Liege, Department of Pneumology, Centre Hospitalier Universitaire Liège, Liege, Belgium (R.L.).""}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Louis', 'Affiliation': ""From the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, Department of Respiratory Sciences, University of Leicester, Leicester (C.E.B., D.J.C.), and the University of Manchester, Manchester University NHS Foundation Trust, Manchester (D.S.) - both in the United Kingdom; the Firestone Institute for Respiratory Health, McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (P.N.); and the GIGA-I3 Research Unit, University of Liege, Department of Pneumology, Centre Hospitalier Universitaire Liège, Liege, Belgium (R.L.).""}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': ""From the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, Department of Respiratory Sciences, University of Leicester, Leicester (C.E.B., D.J.C.), and the University of Manchester, Manchester University NHS Foundation Trust, Manchester (D.S.) - both in the United Kingdom; the Firestone Institute for Respiratory Health, McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (P.N.); and the GIGA-I3 Research Unit, University of Liege, Department of Pneumology, Centre Hospitalier Universitaire Liège, Liege, Belgium (R.L.).""}]",The New England journal of medicine,['10.1056/NEJMoa2030880']
2065,34711126,"Safety and tolerability of linagliptin in Asians with type 2 diabetes: a pooled analysis of 4457 patients from 21 randomized, double-blind, placebo-controlled clinical trials.","BACKGROUND


Safety and tolerability of glucose-lowering drugs is a key consideration for use in type 2 diabetes (T2D). We evaluated the safety and tolerability of the dipeptidyl peptidase-4 inhibitor linagliptin in Asian patients with T2D.
RESEARCH DESIGN AND METHODS


This was a post-hoc, descriptive pooled analysis of 21 randomized, double-blind, placebo-controlled clinical trials of linagliptin in T2D patients lasting ≤52 weeks. We evaluated adverse events (AEs) and laboratory parameters in Asian participants living in Asia, both overall and in the East Asian subgroup.
RESULTS


This analysis included 4457 Asian patients overall (2712 receiving linagliptin; 1745 receiving placebo) and 3057 (68.6%) East Asians. AEs were reported in 1510 (55.7%) Asian patients receiving linagliptin and 1032 (59.1%) receiving placebo but were considered drug-related in only 13.0% of each group. Serious AEs occurred in 109 (4.0%) linagliptin patients and 90 (5.2%) placebo patients. The most common AEs were nasopharyngitis (6.4% linagliptin, 7.3% placebo), upper respiratory tract infection (5.7% linagliptin, 6.5% placebo), and hypoglycemia (7.3% linagliptin, 6.3% placebo). One linagliptin patient had pancreatitis; none had bullous pemphigoid. No clinically relevant mean changes in laboratory parameters occurred. These findings were consistent in East Asians.
CONCLUSIONS


Linagliptin is well tolerated in Asian T2D patients, including East Asians, with low risk for AEs.",2021,AEs were reported in 1510 (55.7%),"['Asian T2D patients, including East Asians, with low risk for AEs', 'Asian patients receiving', '4457 Asian patients overall (2712 receiving linagliptin; 1745 receiving placebo) and 3057 (68.6%) East Asians', 'Asian participants living in Asia, both overall and in the East Asian subgroup', '4457 patients from 21 randomized', 'Asians with type 2 diabetes', 'type 2 diabetes (T2D', 'T2D patients lasting ≤52 weeks', 'Asian patients with T2D']","['glucose-lowering drugs', 'Linagliptin', 'linagliptin', 'dipeptidyl peptidase-4 inhibitor linagliptin', 'placebo']","['adverse events (AEs) and laboratory parameters', 'Serious AEs', 'hypoglycemia', 'upper respiratory tract infection', 'Safety and tolerability', 'nasopharyngitis', 'safety and tolerability']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",4457.0,0.559004,AEs were reported in 1510 (55.7%),"[{'ForeName': 'Keizo', 'Initials': 'K', 'LastName': 'Kanasaki', 'Affiliation': 'Department of Internal Medicine 1, Faculty of Medicine, Shimane University, Izumo, Japan.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Yamamoto', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Schepers', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Sani Simões', 'Affiliation': 'Global Patient Safety & Pharmacovigilance, Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yabe', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism and Department of Rheumatology and Clinical Immunology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.""}]",Expert opinion on drug safety,['10.1080/14740338.2022.1999409']
2066,34677153,Ozone gas applied through nebulization as adjuvant treatment for lung respiratory diseases due to COVID-19 infections: a prospective randomized trial.,"The objective of this study was to provide lung disinfection by nebulizing ozone gas with distilled water and olive oil for patients who have clinical symptoms due to coronavirus disease 2019 (COVID-19). The study attempted to reduce the viral load of COVID-19 in the lungs of patients, to provide a faster response to medical treatment. Between August 2020 and September 2020, 30 patients who met the study criteria were prospectively evaluated. There were 2 groups with 15 patients in each group: patients in control group were not treated with ozone and only received standard COVID-19 treatment; patients in ozone group received lung disinfection technique with ozone and standard COVID-19 treatment. A statistically significant difference was found in the length of stay in hospital, change in C-reactive protein, polymerase chain reaction results after 5 days, and computed tomography scores between two groups. There was no statistically significant difference in D-dimer, urea, lactate dehydrogenase, lymphocyte, leukocyte, and platelet between two groups. According to the data, we think that the lung disinfection technique applied with ozone inhalation reduces the rate of pneumonia in COVID-19 patients and makes the patients respond faster to the treatment and become negative according to the polymerase chain reaction tests. The study was approved by the Ethical Committee of the Istanbul Medipol University Clinical Trials (approval No. 0011) on July 2, 2020.",2022,"There was no statistically significant difference in D-dimer, urea, lactate dehydrogenase, lymphocyte, leukocyte, and platelet between two groups.","['patients who have clinical symptoms due to coronavirus disease 2019 (COVID-19', 'Istanbul Medipol University Clinical Trials', 'Between August 2020 and September 2020, 30 patients who met the study criteria were prospectively evaluated', 'lung respiratory diseases due to COVID-19 infections']","['standard COVID-19 treatment; patients in ozone group received lung disinfection technique with ozone and standard COVID-19 treatment', 'Ozone gas applied through nebulization', 'nebulizing ozone gas with distilled water and olive oil', 'ozone inhalation']","['computed tomography scores', 'length of stay in hospital, change in C-reactive protein, polymerase chain reaction results', 'D-dimer, urea, lactate dehydrogenase, lymphocyte, leukocyte, and platelet', 'viral load of COVID-19', 'rate of pneumonia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",,0.0340695,"There was no statistically significant difference in D-dimer, urea, lactate dehydrogenase, lymphocyte, leukocyte, and platelet between two groups.","[{'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Dengiz', 'Affiliation': 'Edis Pharma Pharmaceutical Industry, Istanbul, Turkey.'}, {'ForeName': 'Çağrı', 'Initials': 'Ç', 'LastName': 'Özcan', 'Affiliation': 'Health Science Univercity, Umraniye Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yusuf İzzettin', 'Initials': 'Yİ', 'LastName': 'Güven', 'Affiliation': 'Dr. Feriha Öz Emergency Hospital, İstanbul, Turkey.'}, {'ForeName': 'Selcen', 'Initials': 'S', 'LastName': 'Uçar', 'Affiliation': 'Dr. Feriha Öz Emergency Hospital, İstanbul, Turkey.'}, {'ForeName': 'Behçet Kemal', 'Initials': 'BK', 'LastName': 'Ener', 'Affiliation': 'Health Science Univercity, Umraniye Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Semih', 'Initials': 'S', 'LastName': 'Sözen', 'Affiliation': 'Pendik State Hospital, İsttanbul, Turkey.'}, {'ForeName': 'Buket', 'Initials': 'B', 'LastName': 'Yağcı', 'Affiliation': 'Health Science Univercity, Haydarpasa Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'İnal Albek', 'Initials': 'İA', 'LastName': 'Güzel', 'Affiliation': 'Dr. Feriha Öz Emergency Hospital, İstanbul, Turkey.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Yiğit', 'Affiliation': 'Dr. Feriha Öz Emergency Hospital, İstanbul, Turkey.'}, {'ForeName': 'Aslınur', 'Initials': 'A', 'LastName': 'Andaç', 'Affiliation': 'Pendik State Hospital, İsttanbul, Turkey.'}, {'ForeName': 'Beyza', 'Initials': 'B', 'LastName': 'Güneş', 'Affiliation': 'Pendik State Hospital, İsttanbul, Turkey.'}, {'ForeName': 'Emire', 'Initials': 'E', 'LastName': 'Bor', 'Affiliation': 'Edis Pharma Pharmaceutical Industry, Istanbul, Turkey.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Karabudak', 'Affiliation': 'Edis Pharma Pharmaceutical Industry, Istanbul, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kaya', 'Affiliation': 'Edis Pharma Pharmaceutical Industry, Istanbul, Turkey.'}]",Medical gas research,['10.4103/2045-9912.326001']
2067,34673305,S-1 Combined With Apatinib and Trans-arterial Chemotherapy and Embolization for Conversion Therapy of Unresectable Locally Advanced Gastric Cancer.,"BACKGROUND


Conversion therapy is a promising option for unresectable locally advanced gastric cancer (GC) patients. This study aimed to investigate the feasibility and efficacy of conversion therapy based on S-1, apatinib combined with transarterial chemotherapy and embolization (TACE).
MATERIALS AND METHODS


Twenty eligible unresectable locally advanced GC patients were enrolled in this single-arm, single-center, prospective clinical trial. Apatinib was administered orally at 0.5 g once daily and continuously for 58 d, while S-1 twice daily on d 1-14 was given at a dose calculated according to the body surface area and repeated every 3 wk for three cycles. TACE (oxaliplatin 80 mg/m 2  and etoposide 80 mg/m 2 ) was performed on d 1 and was repeated on d 31.
RESULTS


Nineteen patients completed conversion therapy and no treatment-related deaths occurred. The objective response rate (ORR) was 94.7% (18/19) and noncurative factors had resolved in 13 patients (68.4%) based on imaging estimation. 18 patients received laparoscopic examination and 12 cases underwent definitive surgery. Based on the intraoperative and postoperative pathological examination, 10 patients received radical resection (R0 + D2/D2+). The patients who underwent the conversion surgery had a superior median overall survival (OS) compared with those who did not (P = 0.010).
CONCLUSIONS


S-1 combined with apatinib and TACE regimen is feasible for preoperative treating initial unresectable locally advanced GC patients with high rates of objective response and radical resection which may provide a survival benefit.",2021,The objective response rate (ORR) was 94.7% (18/19) and noncurative factors had resolved in 13 patients (68.4%) based on imaging estimation.,"['unresectable locally advanced gastric cancer (GC) patients', 'Unresectable Locally Advanced Gastric Cancer', '18 patients received', 'Twenty eligible unresectable locally advanced GC patients']","['TACE (oxaliplatin 80 mg/m 2  and etoposide', 'definitive surgery', 'S-1 Combined With Apatinib and Trans-arterial Chemotherapy and Embolization', 'laparoscopic examination', 'conversion therapy based on S-1, apatinib combined with transarterial chemotherapy and embolization (TACE', 'S-1 combined with apatinib and TACE', 'radical resection (R0\xa0+\xa0D2/D2']","['superior median overall survival (OS', 'objective response rate (ORR']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2346836', 'cui_str': 'apatinib'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",20.0,0.0521562,The objective response rate (ORR) was 94.7% (18/19) and noncurative factors had resolved in 13 patients (68.4%) based on imaging estimation.,"[{'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Zhaoran', 'Affiliation': ""Department of Gastrointestinal Surgery, people's hospital of Tongling City, Tongling, Anhui, People's Republic of China; Department of Digestive endoscopy, people's hospital of Tongling City, Tongling, Anhui, People's Republic of China.""}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Min', 'Affiliation': ""Department of Pathology, people's hospital of Tongling City, Tongling, Anhui, People's Republic of China.""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Kuanshan', 'Affiliation': ""Department of Gastrointestinal Surgery, people's hospital of Tongling City, Tongling, Anhui, People's Republic of China; Department of Digestive endoscopy, people's hospital of Tongling City, Tongling, Anhui, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Kunfeng', 'Affiliation': ""Department of Interventional Radiology, people's hospital of Tongling City, Tongling, Anhui, People's Republic of China.""}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Guihe', 'Affiliation': ""Department of Gastrointestinal Surgery, people's hospital of Tongling City, Tongling, Anhui, People's Republic of China; Department of Digestive endoscopy, people's hospital of Tongling City, Tongling, Anhui, People's Republic of China. Electronic address: 2175613200@qq.com.""}]",The Journal of surgical research,['10.1016/j.jss.2021.09.012']
2068,34709175,Tranexamic acid and reduction of blood transfusion in lower limb trauma surgery: a randomized controlled study.,"INTRODUCTION


Post-operative blood loss in lower limb trauma fractures increases morbidity. Very few studies have evaluated the efficacy of Tranexamic Acid (TXA) in reducing blood loss and the consequent requirement of blood transfusion in the Indian population.
METHODS


This was a randomized controlled study of 100 patients with lower limb trauma. Fifty patients were given 1 g of TXA before surgery, and 50 patients were not given TXA. The requirement of blood transfusion, fall in Hb, the number of days admitted in the hospital after surgery were recorded, and evidence of deep vein thrombosis (DVT) was monitored.
RESULTS


Baseline demographics between the groups were comparable. The required blood transfusion and fall in Hb in patients receiving intra-operative TXA were significantly lower than those not given TXA (p < 0.0001). There was no significant difference in the length of hospital stay between the two groups (p = 0.6). There was no significant difference in the incidence of DVT in both groups.
DISCUSSION


TXA helps reduce the morbidity of trauma patients by reducing the requirement for blood transfusion. Its use is safe in lower limb trauma surgery and lowers the cost of therapy to the patient.",2021,The required blood transfusion and fall in Hb in patients receiving intra-operative TXA were significantly lower than those not given TXA (p < 0.0001).,"['lower limb trauma surgery', 'Fifty patients', '100 patients with lower limb trauma']","['Tranexamic Acid (TXA', 'Tranexamic acid', 'TXA']","['blood loss', 'deep vein thrombosis (DVT', 'length of hospital stay', 'blood transfusion', 'incidence of DVT']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",100.0,0.0859481,The required blood transfusion and fall in Hb in patients receiving intra-operative TXA were significantly lower than those not given TXA (p < 0.0001).,"[{'ForeName': 'Gurleen', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'Professor, Department of Pharmacology, Adesh Medical College & Hospital, Kurukshetra, Haryana 136135, India.'}, {'ForeName': 'Harpal Singh', 'Initials': 'HS', 'LastName': 'Selhi', 'Affiliation': 'Professor, Department of Orthopaedics, Dayanand Medical College & Hospital, Ludhiana, Punjab 141001, India.'}, {'ForeName': 'Naresh Jyoti', 'Initials': 'NJ', 'LastName': 'Delmotra', 'Affiliation': 'Professor & Head, Department of Pharmacology, Adesh Medical College & Hospital, Kurukshetra, Haryana 136135, India.'}, {'ForeName': 'Jaspreet', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Assistant Professor, Department of Orthopaedics, Government Medical College, Patiala, Punjab 147001, India.'}]",SICOT-J,['10.1051/sicotj/2021053']
2069,34710538,Effect of High-definition Transcranial Direct Current Stimulation on Conditioned Pain Modulation in Healthy Adults: A Crossover Randomized Controlled Trial.,"The disorder of the conditioned pain modulation (CPM) system is one of the main causes of pain perception in individuals. High-definition transcranial direct current stimulation (HD-tDCS) targeting specific brain areas was indicated to have an analgesic effect possibly by activating the endogenous pain inhibition pathway evident in CPM. However, discrepancies were found in previous limited studies of varied homogeneity and quality. Therefore, the present study applied 2 mA HD-tDCS (20 min) in the left primary motor cortex (M1) among 35 healthy adults with a blinded crossover study design, to investigate its effectiveness on optimizing the analgesic effect in healthy individuals through assessing changes of the CPM. The univariate and multivariate general linear models were used to evaluate the intervention effect between-group on the Δ-value (after-intervention minus before-intervention) during CPM (primary outcome), pressure pain threshold (PPT), and cold pressure threshold (CPT) (secondary outcome), respectively. A significant between-group difference in Δ-CPM was found for active stimulation. HD-tDCS significantly improved the analgesic efficiency of Δ-CPM, compared with the sham control, after adjusting the confounding factors including age, gender, psychological status, as well as the sequence effect. The changes of CPM were positively correlated with the total physical activity volume. In conclusion, our findings provide evidence support to the effectiveness of HD-tDCS on endogenous pain modulation among healthy adults. Further studies are required to explore the analgesic effect of tDCS among patients with chronic pain, thereby facilitating optimal chronic pain management.",2021,"HD-tDCS significantly improved the analgesic efficiency of Δ-CPM, compared with the sham control, after adjusting the confounding factors including age, gender, psychological status, as well as the sequence effect.","['individuals', 'healthy individuals', '35 healthy adults', 'Healthy Adults', 'patients with chronic pain', 'healthy adults']","['High-definition transcranial direct current stimulation (HD-tDCS', 'High-definition Transcranial Direct Current Stimulation', 'HD-tDCS']","['endogenous pain modulation', 'pressure pain threshold (PPT), and cold pressure threshold (CPT', 'total physical activity volume', 'analgesic efficiency of Δ-CPM', 'Conditioned Pain Modulation', 'Δ-CPM']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",35.0,0.0413621,"HD-tDCS significantly improved the analgesic efficiency of Δ-CPM, compared with the sham control, after adjusting the confounding factors including age, gender, psychological status, as well as the sequence effect.","[{'ForeName': 'Ruihan', 'Initials': 'R', 'LastName': 'Wan', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Department of Sport Rehabilitation, Shenyang Sport University, Shenyang, China.'}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Beibei', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Department of Orthopedics & Traumatology, The University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Department of Sport Rehabilitation, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yangfan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ziping', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Kinesiology, California State University, Northridge, United States.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: wangyul@mail.sysu.edu.cn.'}]",Neuroscience,['10.1016/j.neuroscience.2021.10.019']
2070,34710842,Examining the effect of exercise on the relationship between affect and cravings among smokers engaged in cessation treatment.,"Cigarette smoking is associated with multiple adverse health outcomes. When smokers attempt to quit smoking, one of the leading predictors of relapse are cravings. Recent research shows a relationship between positive and negative affect, exercise, and cravings, but the exact nature of this relationship has yet to be understood. This study explored the relationships between positive and negative affect and cravings in a sample of participants with elevated levels of depressive symptoms (N = 202; 68.8% female; mean age = 46.1 years) who were enrolled in a smoking cessation trial to test the efficacy of a 12-week exercise intervention relative to a health education control on smoking outcomes. Data on affect and craving were gathered before weekly study intervention sessions, and data on cravings were gathered again after each session. The results showed that negative affect had a significant and positive association with cravings before an exercise or health education session. After the session, positive and negative affect were not significant predictors of changes in cravings from pre-session. However, regardless of level of positive or negative affect participants in the exercise condition showed greater reductions in craving pre- to post-class than those in the control condition. These findings suggest that negative affect is associated with cravings, but cravings can be mitigated by exercise.",2021,The results showed that negative affect had a significant and positive association with cravings before an exercise or health education session.,"['participants with elevated levels of depressive symptoms (N\xa0', '202; 68.8% female; mean age\xa0=\xa046.1\xa0years) who were enrolled in a smoking cessation trial']",['exercise intervention relative to a health education control'],['craving pre'],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",,0.0135841,The results showed that negative affect had a significant and positive association with cravings before an exercise or health education session.,"[{'ForeName': 'Zachary J', 'Initials': 'ZJ', 'LastName': 'Kunicki', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, United States. Electronic address: zachary_kunicki@brown.edu.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallgren', 'Affiliation': 'Karolinska Institute, Department of Global Public Health, Sweden.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Uebelacker', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, United States; Butler Hospital, Behavioral Medicine and Addictions Research, United States.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'The University of Texas at Austin, School of Nursing, United States.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Price', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, United States.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Abrantes', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, United States; Butler Hospital, Behavioral Medicine and Addictions Research, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.107156']
2071,34704970,Rectal Indomethacin Does Not Mitigate the Systemic Inflammatory Response Syndrome in Acute Pancreatitis: A Randomized Trial.,"INTRODUCTION


Experimental data suggest that nonsteroidal antiinflammatory drugs may prevent disease severity and mortality in acute pancreatitis (AP). The aim of this study was to compare the efficacy of rectal indomethacin vs placebo in reducing the systemic inflammatory response syndrome (SIRS) score in a high-risk AP population for clinical progression.
METHODS


We conducted a single-center, quadruple-blinded, randomized, placebo-controlled trial. Eligible criteria were subjects with AP and SIRS within 72 hours of presentation and those without organ failure. Subjects were allocated in a 1:1 ratio to indomethacin or placebo using simple randomization. Both interventions were administered rectally every 8 hours for 6 doses and compared using both intention-to-treat and per-protocol analyses.
RESULTS


A total of 42 subjects (mean age 52 years, 55% men) were randomized to indomethacin (n = 18) or placebo (n = 24). There was no significant difference between the indomethacin and placebo groups in the change of SIRS score, proportion of subjects with SIRS, and distribution of SIRS scores at 24, 48, and 72 hours from randomization. There were no significant differences in the change of C-reactive protein levels at 48 hours or clinical outcomes between both treatment groups. Indomethacin was as safe as placebo, with 2 adverse events occurring in the placebo and none in the indomethacin arm.
DISCUSSION


Rectal indomethacin can be safely administered over 48 hours; however, it is not superior to placebo in reducing the SIRS or clinical progression in a high-risk population with AP (ClinicalTrials.gov: NCT02692391).",2021,There were no significant differences in the change of C-reactive protein levels at 48 hours or clinical outcomes between both treatment groups.,"['Acute Pancreatitis', 'acute pancreatitis (AP', 'Eligible criteria were subjects with AP and SIRS within 72 hours of presentation and those without organ failure', '42 subjects (mean age 52 years, 55% men']","['Indomethacin', 'indomethacin or placebo', 'Rectal Indomethacin', 'rectal indomethacin vs placebo', 'Rectal indomethacin', 'placebo', 'indomethacin']","['change of C-reactive protein levels', 'systemic inflammatory response syndrome (SIRS) score', 'SIRS score, proportion of subjects with SIRS, and distribution of SIRS scores']","[{'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1960440', 'cui_str': 'Systemic inflammatory response syndrome score'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",42.0,0.460976,There were no significant differences in the change of C-reactive protein levels at 48 hours or clinical outcomes between both treatment groups.,"[{'ForeName': 'Jorge D', 'Initials': 'JD', 'LastName': 'Machicado', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Rawad', 'Initials': 'R', 'LastName': 'Mounzer', 'Affiliation': 'Interventional Endoscopy Associates, Scottsdale, Arizona, USA.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Paragomi', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Pothoulakis', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Phil A', 'Initials': 'PA', 'LastName': 'Hart', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Darwin L', 'Initials': 'DL', 'LastName': 'Conwell', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'de-Madaria', 'Affiliation': 'Gastroenterology Department, Alicante University General Hospital, ISABIAL, Alicante, Spain.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Greer', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Dhiraj', 'Initials': 'D', 'LastName': 'Yadav', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Whitcomb', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Hinton', 'Affiliation': 'Division of Biostatistics, College of Public Health, the Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Georgios I', 'Initials': 'GI', 'LastName': 'Papachristou', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000415']
2072,34710362,"Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial.","BACKGROUND


Surgical site infection (SSI) is the most common postoperative complication worldwide. WHO guidelines to prevent SSI recommend alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures, but called for assessment of both interventions in low-resource settings. This study aimed to test both interventions in low-income and middle-income countries.
METHODS


FALCON was a 2 × 2 factorial, randomised controlled trial stratified by whether surgery was clean-contaminated, or contaminated or dirty, including patients undergoing abdominal surgery with a skin incision of 5 cm or greater. This trial was undertaken in 54 hospitals in seven countries (Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa). Patients were computer randomised 1:1:1:1 to: (1) 2% alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and non-coated suture, or (4) 10% aqueous povidone-iodine and triclosan-coated suture. Patients and outcome assessors were masked to intervention allocation. The primary outcome was SSI, reported by trained outcome assessors, and presented using adjusted relative risks and 95% CIs. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03700749.
FINDINGS


Between Dec 10, 2018, and Sept 7, 2020, 5788 patients (3091 in clean-contaminated stratum, 2697 in contaminated or dirty stratum) were randomised (1446 to alcoholic chlorhexidine and non-coated suture, 1446 to alcoholic chlorhexidine and triclosan-coated suture, 1447 to aqueous povidone-iodine and non-coated suture, and 1449 to aqueous povidone-iodine and triclosan-coated suture). 14·0% (810/5788) of patients were children and 66·9% (3873/5788) had emergency surgery. The overall SSI rate was 22·0% (1163/5284; clean-contaminated stratum 15·5% [454/2923], contaminated or dirty stratum 30·0% [709/2361]). For both strata, there was no evidence of a difference in the risk of SSI with alcoholic chlorhexidine versus povidone-iodine (clean-contaminated stratum 15·3% [223/1455] vs 15·7% [231/1468], relative risk 0·97 [95% CI 0·82-1·14]; contaminated or dirty stratum 28·3% [338/1194] vs 31·8% [371/1167], relative risk 0·91 [95% CI 0·81-1·02]), or with triclosan-coated sutures versus non-coated sutures (clean-contaminated stratum 14·7% [215/1459] vs 16·3% [239/1464], relative risk 0·90 [95% CI 0·77-1·06]; contaminated or dirty stratum 29·4% [347/1181] vs 30·7% [362/1180], relative risk 0·98 [95% CI 0·87-1·10]). With both strata combined, there were no differences using alcoholic chlorhexidine or triclosan-coated sutures.
INTERPRETATION


This trial did not show benefit from 2% alcoholic chlorhexidine skin preparation compared with povidone-iodine, or with triclosan-coated sutures compared with non-coated sutures, in preventing SSI in clean-contaminated or contaminated or dirty surgical wounds. Both interventions are more expensive than alternatives, and these findings do not support recommendations for routine use.
FUNDING


National Institute for Health Research (NIHR) Global Health Research Unit Grant, BD.",2021,"This trial did not show benefit from 2% alcoholic chlorhexidine skin preparation compared with povidone-iodine, or with triclosan-coated sutures compared with non-coated sutures, in preventing SSI in clean-contaminated or contaminated or dirty surgical wounds.","['FALCON was a 2\u2009×\u20092 factorial', '54 hospitals in seven countries (Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa', '5788 patients (3091 in clean-contaminated stratum, 2697 in contaminated or dirty stratum', 'low-income and middle-income countries (FALCON', 'low-income and middle-income countries']","['povidone-iodine, or with triclosan-coated sutures', 'alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures', 'alcoholic chlorhexidine skin preparation', 'alcoholic chlorhexidine', 'abdominal surgery with a skin incision of 5 cm or greater', 'alcoholic chlorhexidine and non-coated suture, 1446 to alcoholic chlorhexidine and triclosan-coated suture, 1447 to aqueous povidone-iodine and non-coated suture, and 1449 to aqueous povidone-iodine and triclosan-coated suture', 'triclosan-coated sutures versus non-coated sutures', 'alcoholic chlorhexidine versus povidone-iodine', 'alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and non-coated suture, or (4) 10% aqueous povidone-iodine and triclosan-coated suture']","['relative risk 0·98', 'overall SSI rate', 'emergency surgery', 'relative risk 0·97', 'NIHR', 'relative risk 0·91', 'relative risk 0·90']","[{'cui': 'C0999244', 'cui_str': 'Falco'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0005005', 'cui_str': 'Benin'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]",5788.0,0.299014,"This trial did not show benefit from 2% alcoholic chlorhexidine skin preparation compared with povidone-iodine, or with triclosan-coated sutures compared with non-coated sutures, in preventing SSI in clean-contaminated or contaminated or dirty surgical wounds.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)01548-8']
2073,34710590,Design and baseline results of a coaching intervention for implementation of trans-radial access in percutaneous coronary intervention.,"Trans-radial artery access (TRA) for cardiac catheterization and percutaneous coronary intervention has many advantages over trans-femoral artery access (TFA), but implementation has been slow. The steep learning curve, logistical issues, and radiation exposure have been documented as barriers to implementation. Although many cardiac catheterization laboratories have overcome these barriers, we lack evidence on effective implementation strategies. Our objective is to test a team-based coaching intervention that targets the learning curve and other barriers to increase use of TRA. We use a stepped-wedge cluster-randomized trial to test a coaching intervention in Department of Veterans Affairs cardiac catheterization laboratories. The coaching intervention comprises team-based didactic instruction with live observation at a TRA-proficient lab, followed by a visit from a cardiologist and catheterization laboratory nurse coaching team. Interview and survey data are collected from participants to test and adapt an implementation science framework known as the Promoting Action on Research Implementation in Health Services (PARIHS) framework. This study is designed to test the effectiveness of the coaching intervention on TRA implementation, inform changes to the coaching intervention itself, and test and adapt the PARIHS framework in practice. While the benefits of TRA, including increased clinical efficiency, patient comfort, and reduced patient complications, are well understood, the underlying drivers of TRA adoption and sustained practice are not. Findings from this trial can inform future research to facilitate change in the cardiac catheterization laboratory.",2021,"Trans-radial artery access (TRA) for cardiac catheterization and percutaneous coronary intervention has many advantages over trans-femoral artery access (TFA), but implementation has been slow.","['Department of Veterans Affairs cardiac catheterization laboratories', 'percutaneous coronary intervention']","['TRA', 'Trans-radial artery access (TRA', 'coaching intervention']","['clinical efficiency, patient comfort, and reduced patient complications']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0621375,"Trans-radial artery access (TRA) for cardiac catheterization and percutaneous coronary intervention has many advantages over trans-femoral artery access (TFA), but implementation has been slow.","[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaver', 'Affiliation': 'Department of Veterans Affairs Puget Sound Health Care System, 1660 South Columbian Way S-152, Seattle, WA 98018, United States of America. Electronic address: Kristine.Beaver@va.gov.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Naranjo', 'Affiliation': 'Department of Veterans Affairs Puget Sound Health Care System, 1660 South Columbian Way S-152, Seattle, WA 98018, United States of America.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Doll', 'Affiliation': 'Department of Veterans Affairs Puget Sound Health Care System, 1660 South Columbian Way S-152, Seattle, WA 98018, United States of America.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Maynard', 'Affiliation': 'Department of Veterans Affairs Puget Sound Health Care System, 1660 South Columbian Way S-152, Seattle, WA 98018, United States of America.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'Department of Veterans Affairs Puget Sound Health Care System, 1660 South Columbian Way S-152, Seattle, WA 98018, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Plomondon', 'Affiliation': 'Department of Veterans Affairs Eastern Colorado Health Care System, 1055 Clermont St, Denver, CO 80220, United States of America; Clinical Assessment Reporting and Tracking Program, Department of Veterans Affairs Office of Quality and Patient Safety, 810 Vermont Avenue NW, Washington, DC 20420, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Waldo', 'Affiliation': 'Department of Veterans Affairs Eastern Colorado Health Care System, 1055 Clermont St, Denver, CO 80220, United States of America; Clinical Assessment Reporting and Tracking Program, Department of Veterans Affairs Office of Quality and Patient Safety, 810 Vermont Avenue NW, Washington, DC 20420, United States of America.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Helfrich', 'Affiliation': 'Department of Veterans Affairs Puget Sound Health Care System, 1660 South Columbian Way S-152, Seattle, WA 98018, United States of America.'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Department of Veterans Affairs Durham Health Care System, 508 Fulton Street Durham, NC 27705, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106606']
2074,34710566,Migration and Inducible Displacement of the Bicruciate-Stabilized Total Knee Arthroplasty: A Randomized Controlled Trial of Gap Balancing and Measured Resection Techniques.,"BACKGROUND


The goal of this study is to investigate the migration and inducible displacement of a bicruciate-stabilized (BCS) total knee arthroplasty implanted using gap balancing (GB) or measured resection (MR) surgical techniques. We hypothesized equal migration and displacement between the techniques.
METHODS


The study is a single-blinded, prospective, randomized controlled trial, with allocation of 71 patients to either GB or MR groups. Fifteen patients were withdrawn, resulting in 31 patients in the GB group and 25 in the MR group. Patients received the JOURNEY II™ BCS implant. Migration and inducible displacement were evaluated using radiostereometric analysis and patient examinations were performed at a 2-week baseline, and at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperation.
RESULTS


No differences (P > .05) existed between GB and MR groups for any measurement of tibial or femoral migration. Both groups had tibial migrations below 0.5 mm from baseline to 6 months, and below 0.2 mm from both 6 months to 1 year and 1-2 years postoperation. No differences (P > .05) were found between GB and MR groups for inducible displacement.
CONCLUSION


No differences were found in implant migration or inducible displacement between GB and MR groups. The BCS implant can be expected to have migration risks on par with industry standards and both surgical techniques are safe and effective options for implantation of this implant design.",2021,No differences (p>0.05) existed between GB and MR groups for any measurement of tibial or femoral migration.,"['71 patients to either GB or MR groups', 'Fifteen patients were withdrawn, resulting in 31 patients in the GB group and 25 in the MR group', 'Bi-Cruciate Stabilized Total Knee Arthroplasty']","['Gap Balancing and Measured Resection Techniques', 'bi-cruciate stabilized (BCS) total knee arthroplasty (TKA) implanted using gap balancing (GB) or measured resection (MR) surgical techniques']","['implant migration or inducible displacement', 'tibial or femoral migration', 'tibial migrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",15.0,0.0953734,No differences (p>0.05) existed between GB and MR groups for any measurement of tibial or femoral migration.,"[{'ForeName': 'Jordan S', 'Initials': 'JS', 'LastName': 'Broberg', 'Affiliation': 'Department of Medical Biophysics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada; Imaging Research Laboratories, Robarts Research Institute, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada; Surgical Innovation Program, Lawson Health Research Institute, London, ON, Canada.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Vasarhelyi', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, Schulich School of Medicine and Dentistry, Western University and London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Lanting', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, Schulich School of Medicine and Dentistry, Western University and London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Howard', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, Schulich School of Medicine and Dentistry, Western University and London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Teeter', 'Affiliation': 'Department of Medical Biophysics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada; Imaging Research Laboratories, Robarts Research Institute, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada; Surgical Innovation Program, Lawson Health Research Institute, London, ON, Canada; Division of Orthopaedic Surgery, Department of Surgery, Schulich School of Medicine and Dentistry, Western University and London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Douglas D R', 'Initials': 'DDR', 'LastName': 'Naudie', 'Affiliation': 'Department of Medical Biophysics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada; Imaging Research Laboratories, Robarts Research Institute, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada; Division of Orthopaedic Surgery, Department of Surgery, Schulich School of Medicine and Dentistry, Western University and London Health Sciences Centre, London, ON, Canada.'}]",The Journal of arthroplasty,['10.1016/j.arth.2021.10.010']
2075,34714523,Cost-Effectiveness of iGlarLixi in People with Type 2 Diabetes Mellitus Suboptimally Controlled on Basal Insulin Plus Metformin in the UK.,"INTRODUCTION


A cost-effectiveness analysis was conducted comparing a fixed-ratio combination (FRC) of insulin glargine 100 units/mL plus lixisenatide (iGlarLixi) versus the FRC of insulin degludec plus liraglutide (iDegLira) and the free-combination comparators insulin glargine plus dulaglutide (iGlar plus Dula) and basal insulin plus liraglutide (BI plus Lira).
METHODS


The IQVIA Core Diabetes Model was used to estimate lifetime costs and outcomes for a cohort of patients with type 2 diabetes mellitus (T2DM) from the UK healthcare perspective. Initial clinical data for iGlarLixi were based on the randomized, controlled LixiLan-L trial and the relative treatment effects for comparators were based on an indirect treatment comparison using data from the AWARD-9 (iGlar plus Dula), LIRA ADD2 BASAL (BI plus Lira), and DUAL V (iDegLira) trials. Costs were derived from publicly available sources. Lifetime costs (in British Pound Sterling [£]) and quality-adjusted life-years (QALYs) were predicted; net monetary benefit (NMB) for iGlarLixi versus comparators was derived using a willingness-to-pay threshold of £20,000. Extensive scenario and sensitivity analyses were conducted.
RESULTS


Estimated costs were lowest with iGlarLixi (£31,295) compared with iGlar plus Dula (£38,790), iDegLira (£40,179), and BI plus Lira (£42,467). Total QALYs gained were identical with iGlarLixi and iDegLira (8.438), and comparable with iGlar plus Dula (8.439) and BI plus Lira (8.466). NMB for iGlarLixi was positive versus all comparators (£10,603.86 vs. BI plus Lira; £7,466.24 vs. iGlar plus Dula; £8.874.11 vs. iDegLira).
CONCLUSION


In patients with T2DM with suboptimal glycemic control on basal insulin, iGlarLixi provides very similar outcomes and substantial cost savings, compared with other fixed and free combinations of insulins plus glucagon-like peptide-1 receptor agonists.",2021,"RESULTS


Estimated costs were lowest with iGlarLixi (£31,295) compared with iGlar plus Dula (£38,790), iDegLira (£40,179), and BI plus Lira (£42,467).","['patients with type 2 diabetes mellitus (T2DM) from the UK healthcare perspective', 'People with Type 2 Diabetes Mellitus']","['fixed-ratio combination (FRC) of insulin glargine 100 units/mL plus lixisenatide (iGlarLixi) versus the FRC of insulin degludec plus liraglutide (iDegLira) and the free-combination comparators insulin glargine plus dulaglutide (iGlar plus Dula) and basal insulin plus liraglutide (BI plus Lira', 'Basal Insulin Plus Metformin', 'iGlarLixi']","['Lifetime costs', 'quality-adjusted life-years (QALYs', 'Cost-Effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0997895,"RESULTS


Estimated costs were lowest with iGlarLixi (£31,295) compared with iGlar plus Dula (£38,790), iDegLira (£40,179), and BI plus Lira (£42,467).","[{'ForeName': 'Rory J', 'Initials': 'RJ', 'LastName': 'McCrimmon', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, UK.'}, {'ForeName': 'Edel', 'Initials': 'E', 'LastName': 'Falla', 'Affiliation': 'IQVIA, Real-World Solutions, London, UK.'}, {'ForeName': 'Jo Zhou', 'Initials': 'JZ', 'LastName': 'Sha', 'Affiliation': 'IQVIA, Real-World Solutions, London, UK.'}, {'ForeName': 'Abdul Jabbar Omar', 'Initials': 'AJO', 'LastName': 'Alsaleh', 'Affiliation': 'Department of Economics, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Elisheva', 'Initials': 'E', 'LastName': 'Lew', 'Affiliation': 'Sanofi, Paris, France. Elisheva.Lew@sanofi.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hudson', 'Affiliation': 'Sanofi, Reading, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Baxter', 'Affiliation': 'Sanofi, Reading, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Palmer', 'Affiliation': 'Sanofi, Reading, UK.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-021-01159-y']
2076,34688044,Sacituzumab govitecan in metastatic triple negative breast cancer (TNBC): Four design features in the ASCENT trial potentially favored the experimental arm.,"The ASCENT trial reports impressive results with a median overall survival (OS) increased from 6.7 months to 12.1 months with sacituzumab govitecan over single-agent chemotherapy, in metastatic triple negative breast cancer (TNBC) patients in second and subsequent line of therapy. We described design features in the ASCENT trial casting doubt on the extrapolation of the reported results to real world patients. First, the open-label design may exaggerate the effect of the experimental arm. Second, the choice of progression-free-survival (PFS) as a primary endpoint, debatable in metastatic TNBC, can lead to biases: early stopping rules may exaggerate efficacy results and informative censoring can bias PFS results interpretation. Third, the control arm was not a complete ""physician's choice"": it was restricted, preventing from using effective agents in this setting, and leading to a substandard control arm. Fourth and lastly, dose reduction and supportive care recommendations for the experimental drug were different between the trial protocol and the FDA labels, and favored the experimental arm as compared with the control arm. In conclusion, we described four design features in the ASCENT trial having the potential to favor the experimental arm or to penalize the control arm. It thus remains uncertain in which extent the reported outcomes will translate in the real world. Efforts should be made to avoid trial biases that will eventually prevent to conclude about their true impact in patients when applied broadly.",2021,"The ASCENT trial reports impressive results with a median overall survival (OS) increased from 6.7 months to 12.1 months with sacituzumab govitecan over single-agent chemotherapy, in metastatic triple negative breast cancer (TNBC) patients in second and subsequent line of therapy.",['metastatic triple negative breast cancer (TNBC'],['Sacituzumab govitecan'],"['choice of progression-free-survival (PFS', 'median overall survival (OS']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}]","[{'cui': 'C4086837', 'cui_str': 'sacituzumab govitecan'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0807676,"The ASCENT trial reports impressive results with a median overall survival (OS) increased from 6.7 months to 12.1 months with sacituzumab govitecan over single-agent chemotherapy, in metastatic triple negative breast cancer (TNBC) patients in second and subsequent line of therapy.","[{'ForeName': 'Timothee', 'Initials': 'T', 'LastName': 'Olivier', 'Affiliation': 'Department of Oncology, Geneva University Hospital, 4 Gabrielle-Perret-Gentil Street, Geneva 1205 Switzerland. Electronic address: timothee.olivier@hcuge.ch.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Prasad', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, 550 16th St, 2nd Fl, San Francisco, CA 94158, United States.'}]",Translational oncology,['10.1016/j.tranon.2021.101248']
2077,34723446,An experimental test of resource recovery from physical and relaxation work break activities.,"Actual resource replenishment, a defining part of the stress-recovery process, has hardly been studied. We address this gap in the literature within the context of work breaks to determine which resources are replenished relative to a pre-stressor baseline. Guided by conservation of resources theory and the effort-recovery model, we explored how two different break activities promoted recovery by looking at their effects on recovery experiences (relaxation, psychological detachment), psychological resources (self-regulatory capacity, energy), and an indicator of insufficient recovery (fatigue). In a sample of 160 college students, we experimentally induced a state of resource depletion via mentally demanding tasks and randomly assigned people to a physical (stationary bike) or relaxation (progressive muscle relaxation) recovery break activity. The relaxation activity resulted in higher psychological detachment and relaxation experiences, the physical activity resulted in higher energy levels, and there were no differences between the break activities for self-regulatory capacity or fatigue. Overall, post-break resource levels improved following recovery break activities. Energy levels returned to baseline (replenishment); self-regulatory capacity and fatigue improved beyond baseline (accumulation). These resource replenishment and accumulation findings further the development of recovery theory and help employees select a work break activity that better meets their resource-related needs.",2021,"The relaxation activity resulted in higher psychological detachment and relaxation experiences, the physical activity resulted in higher energy levels, and there were no differences between the break activities for self-regulatory capacity or fatigue.",['160 college students'],['resource depletion via mentally demanding tasks and randomly assigned people to a physical (stationary bike) or relaxation (progressive muscle relaxation) recovery break activity'],"['Energy levels returned to baseline (replenishment); self-regulatory capacity and fatigue improved beyond baseline (accumulation', 'relaxation activity', 'recovery experiences (relaxation, psychological detachment), psychological resources (self-regulatory capacity, energy), and an indicator of insufficient recovery (fatigue', 'break activities for self-regulatory capacity or fatigue']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392218', 'cui_str': 'Bicycle exerciser'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]",160.0,0.104451,"The relaxation activity resulted in higher psychological detachment and relaxation experiences, the physical activity resulted in higher energy levels, and there were no differences between the break activities for self-regulatory capacity or fatigue.","[{'ForeName': 'Coty S', 'Initials': 'CS', 'LastName': 'Hoover', 'Affiliation': 'Psychology Department, University of Tulsa, Tulsa, OK, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Ragsdale', 'Affiliation': 'Psychology Department, University of Tulsa, Tulsa, OK, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Ayres', 'Affiliation': 'Psychology Department, University of Tulsa, Tulsa, OK, USA.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.3108']
2078,34719055,Tooth Wear Evaluation System (TWES) 2.0-Reliability of diagnosis with and without computer-assisted evaluation.,"BACKGROUND


Tooth wear is a multifactorial process, leading to the loss of dental hard tissues. Therefore, it is important to detect the level of tooth wear at an early stage, so monitoring can be initiated. The Tooth Wear Evaluation System (TWES) enables such a multistage diagnosis of tooth wear. The further developed TWES 2.0 contains a complete taxonomy of tooth wear, but its reliability has not yet been validated.
OBJECTIVES


The aim of the study was to examine in a randomised controlled trial (RCT) whether diagnoses made based on the TWES 2.0 are reproducible and whether this reproducibility is also achieved with computer-assisted diagnostics.
METHODS


44 dental students received extensive training in TWES 2.0 assessment and taxonomy. The students each evaluated at least 10 (of the present 14) anonymised patient cases using gypsum models and high-resolution intra-oral photographs according to TWES 2.0. One half initially evaluated on paper; the other half used dedicated software (CMDfact / CMDbrux). After half of the patient cases (5), the evaluation methods were switched (AB/BA crossover design). The diagnoses were then evaluated for agreement with the predefined sample solution.
RESULTS


Evaluation of agreement with the sample solution according to Cohen's kappa indicated a value of 0.46 for manual (traditional) evaluation; and 0.44 for computer-assisted evaluation. Evaluation of agreement between examiners was 0.38 for manual and 0.48 for computer-assisted evaluation (Fleiss' kappa).
CONCLUSION


The results of this study proved that the taxonomy of the TWES 2.0 has acceptable reliability and can thus be used by dentists. Accordingly, the system can be learned quickly even by untrained practitioners. Comparable results are achieved with computer-assisted evaluation.",2021,"Evaluation of agreement between examiners was 0,38 for manual and 0,48 for computer-assisted evaluation (Fleiss' Kappa).
",['44 dental students received'],['extensive training in TWES 2.0 assessment and taxonomy'],['Tooth Wear Evaluation System (TWES'],"[{'cui': 'C0038493', 'cui_str': 'Dental Student'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008903', 'cui_str': 'classification'}]","[{'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",44.0,0.029146,"Evaluation of agreement between examiners was 0,38 for manual and 0,48 for computer-assisted evaluation (Fleiss' Kappa).
","[{'ForeName': 'Jakob C', 'Initials': 'JC', 'LastName': 'Roehl', 'Affiliation': 'Department of Prosthetic Dentistry, Center for Dental and Oral Medicine, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Holger A', 'Initials': 'HA', 'LastName': 'Jakstat', 'Affiliation': 'Department of Prosthetic Dentistry and Dental Materials and Special Care, Center for Dental and Oral Medicine, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': 'Private Practice, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wetselaar', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'M Oliver', 'Initials': 'MO', 'LastName': 'Ahlers', 'Affiliation': 'Department of Prosthetic Dentistry, Center for Dental and Oral Medicine, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}]",Journal of oral rehabilitation,['10.1111/joor.13277']
2079,34700288,The ThermiVa In Genital Hiatus Treatment (TIGHT) Study.,"INTRODUCTION


Vaginal laxity or the sensation of vaginal looseness affects anywhere from 24% to 50% of postpartum women.
AIM


To evaluate the efficacy and safety of the ThermiVa (ThermiAesthetics, TX, USA) monopolar radiofrequency device in the treatment of vulvovaginal laxity and sexual dysfunction METHODS: The TIGHT study was a prospective single blinded randomized sham-control trial conducted over 3 sites in Australia and India. The study included parous woman over the age of 18 who complained of vaginal laxity/looseness. Participants were randomized into a treatment group and a sham group. Patients in the treatment group were treated with an active probe, whereas, women in the placebo group were treated with sham probes that only reached subtherapeutic temperatures.
MAIN OUTCOME MEASURES


Subjective success was determined by improvement in the Female Sexual Function Index (FSFI), Vaginal Laxity Questionnaire (VLQ), Vaginal Flatus Score (VFS), and the Vaginal laxity Bother Score (VLBS). Objective success was measured via the Modified Oxford Score (MOS) and Genital Hiatus (GH) length.
RESULTS


Sixty-three participants were recruited (sham n = 29, treatment n = 34). In the treatment group, FSFI scores improved at 3 months (mean difference 8-points, P value .02), and at 6 months (mean difference 5-points, P value .07). At baseline 89.7% and 87.2% of patients in the sham and treatment groups, respectively, classified themselves as ""loose"" on the VLQ. At 6 months 73.1% of patients in the sham group still identified as ""loose"" compared to 32.4% of patients in the active group (P value .01). Subjective success was also noted in the VLBS (P value .02). Results pertaining to VLFS, MOS, and GH did not reveal statistically significant results.
CONCLUSION


Treatment with ThermiVa was associated with a modest subjective improvement in vaginal laxity and sexual dysfunction and proved to be safe over the 6-month trial period. Pather K, Dilgir S, Rane A. The ThermiVa In Genital Hiatus Treatment (TIGHT) Study. Sex Med 2021;XX:XXXXXX.",2021,Treatment with ThermiVa was associated with a modest subjective improvement in vaginal laxity and sexual dysfunction and proved to be safe over the 6-month trial period.,"['parous woman over the age of 18 who complained of vaginal laxity/looseness', 'Sixty-three participants were recruited (sham n\xa0=\xa029, treatment n\xa0=\xa034', '3 sites in Australia and India']","['placebo', 'ThermiVa (ThermiAesthetics, TX, USA) monopolar radiofrequency device']","['Objective success', 'loose', 'vaginal laxity and sexual dysfunction', 'Female Sexual Function Index (FSFI), Vaginal Laxity Questionnaire (VLQ), Vaginal Flatus Score (VFS), and the Vaginal laxity Bother Score (VLBS', 'Subjective success', 'Modified Oxford Score (MOS) and Genital Hiatus (GH) length', 'efficacy and safety', 'FSFI scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0425879', 'cui_str': 'Vaginal flatus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",63.0,0.158393,Treatment with ThermiVa was associated with a modest subjective improvement in vaginal laxity and sexual dysfunction and proved to be safe over the 6-month trial period.,"[{'ForeName': 'Kaveshan', 'Initials': 'K', 'LastName': 'Pather', 'Affiliation': 'Department of Obstetrics and Gynecology, Townsville University Hospital, Douglas, Queensland, Australia. Electronic address: kaveshan.pather@gmail.com.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Dilgir', 'Affiliation': 'Department of Obstetrics and Gynecology, Townsville University Hospital, Douglas, Queensland, Australia; Department of Obstetrics and Gynecology, Mater Private Hospital Townsville, Pimlico, Queensland, Australia.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Rane', 'Affiliation': 'Department of Obstetrics and Gynecology, Townsville University Hospital, Douglas, Queensland, Australia; Department of Obstetrics and Gynecology, Mater Private Hospital Townsville, Pimlico, Queensland, Australia.'}]",Sexual medicine,['10.1016/j.esxm.2021.100427']
2080,34710784,"Efficacy of the Orally Disintegrating Strip Sildenafil for the Treatment of Erectile Dysfunction: A Prospective, Randomized Trial.","INTRODUCTION


Phosphodiesterase 5 inhibitors are the predominant treatment option for erectile dysfunction.
AIM


This study evaluates the efficacy and safety of sildenafil orally disintegrating strips for the treatment of erectile dysfunction.
METHODS


One hundred twenty erectile dysfunction patients were enrolled in a prospective, randomized, controlled crossover study and allocated into 2 groups of 60 participants. Patients were either treated with sildenafil strips or tablets for 8 weeks after which they crossed over into the alternate treatment formulation for another 8 weeks following a 4-week wash-out period. Each participant was assessed 8 times throughout the study period and their formulation preference registered at the end of the study.
MAIN OUTCOMES AND MEASURES


Changes in the abridged International Index of Erectile Function (IIEF-5) score and Erection Hardness Score (EHS) resulting from sildenafil orally disintegrating strip or tablet treatments were the primary end points, with differences in onset of action, duration of action, and incidence of adverse events between the 2 formulations included as secondary end points.
RESULTS


Both sildenafil formulations were effective in treating patients with erectile dysfunction. There was significant improvement of erectile function in term of IIEF-5 score and EHS from both formulations. The number and type of adverse events were also comparable. Likewise, there were no statistically significant differences between the earliest onset of action times and longest duration of action times. However, the results showed a 7.1-minute earlier onset of action time for orally disintegrating strips that may be considered as clinically meaningful by some patients.
CONCLUSION


Sildenafil orally disintegrating strips are a safe and effective alternative to the conventional tablet formulation for the treatment of erectile dysfunction. Sangkum P, Sirisopana K, Matang W, et al. Efficacy of the Orally Disintegrating Strip Sildenafil for the Treatment of Erectile Dysfunction: A Prospective, Randomized Trial. Sex Med 2021;XX:XXXXXX.",2021,There was significant improvement of erectile function in term of IIEF-5 score and EHS from both formulations.,"['patients with erectile dysfunction', 'Erectile Dysfunction', 'One hundred twenty erectile dysfunction patients']","['Orally Disintegrating Strip Sildenafil', 'sildenafil', 'Sildenafil', 'sildenafil orally disintegrating strips', 'sildenafil strips or tablets']","['number and type of adverse events', 'Sangkum P, Sirisopana K, Matang W, et', 'onset of action, duration of action, and incidence of adverse events', 'erectile function', 'efficacy and safety', 'action times and longest duration of action times', 'abridged International Index of Erectile Function (IIEF-5) score and Erection Hardness Score (EHS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960554', 'cui_str': 'Erection hardness score'}]",120.0,0.0902233,There was significant improvement of erectile function in term of IIEF-5 score and EHS from both formulations.,"[{'ForeName': 'Premsant', 'Initials': 'P', 'LastName': 'Sangkum', 'Affiliation': 'Division of Urology, Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Sirisopana', 'Affiliation': 'Division of Urology, Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University.'}, {'ForeName': 'Wijittra', 'Initials': 'W', 'LastName': 'Matang', 'Affiliation': 'Division of Urology, Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University.'}, {'ForeName': 'Yada', 'Initials': 'Y', 'LastName': 'Phengsalae', 'Affiliation': 'Division of Urology, Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University.'}, {'ForeName': 'Panuwat', 'Initials': 'P', 'LastName': 'Lertsithichai', 'Affiliation': 'Division of Breast and Endocrine, Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University.'}, {'ForeName': 'Chinnakhet', 'Initials': 'C', 'LastName': 'Ketsuwan', 'Affiliation': 'Division of Urology, Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University.'}, {'ForeName': 'Wachira', 'Initials': 'W', 'LastName': 'Kochakarn', 'Affiliation': 'Division of Urology, Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University.'}, {'ForeName': 'Wisoot', 'Initials': 'W', 'LastName': 'Kongchareonsombat', 'Affiliation': 'Division of Urology, Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University. Electronic address: wisoot.kongcha@gmail.com.'}]",Sexual medicine,['10.1016/j.esxm.2021.100453']
2081,34719829,The effect of perceived life stress on posttraumatic stress disorder treatment outcome.,"Life stress following trauma exposure is a consistent predictor of the development of posttraumatic stress disorder (PTSD). However, there is a dearth of research on the effect of life stress on PTSD treatment outcomes. The current study examined the effects of pretreatment levels of perceived life stress on treatment outcome in a sample of 200 individuals with PTSD who were randomized to receive either prolonged exposure (PE) therapy or sertraline as part of a clinical trial. Life stress over the year prior to treatment significantly interacted with treatment type to predict higher residual PTSD symptom severity, as assessed using the PTSD Symptom Scale-Interview, among participants who received sertraline but not those who received PE, β = .24, p = .017, ∆R 2  = .03. These findings were similar for self-reported depression severity, β = .27, p = .008, ∆R 2  = .04. Adherence to either PE homework or sertraline compliance did not mediate this association nor did life stress predict treatment retention for either treatment arm. Higher levels of perceived life stress may serve as a prescriptive predictor of PTSD treatment outcome, with PE remaining efficacious regardless of heightened pretreatment life stress. These findings encourage clinician confidence when providing PE to individuals with higher levels of life stress. Future researchers should examine the impact of PTSD treatment on perceived and objective measures of life stress to improve treatment for individuals who experience chronic stress.",2021,Adherence to either PE homework or sertraline compliance did not mediate this association nor did life stress predict treatment retention for either treatment arm.,"['individuals who experience chronic stress', '200 individuals with PTSD']","['prolonged exposure (PE) therapy or sertraline', 'sertraline']","['residual PTSD symptom severity', 'Life stress', 'PTSD Symptom Scale-Interview']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",200.0,0.0509618,Adherence to either PE homework or sertraline compliance did not mediate this association nor did life stress predict treatment retention for either treatment arm.,"[{'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Burton', 'Affiliation': 'Department of Psychological Sciences, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Marks', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Michele A', 'Initials': 'MA', 'LastName': 'Bedard-Gilligan', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Norah C', 'Initials': 'NC', 'LastName': 'Feeny', 'Affiliation': 'Department of Psychological Sciences, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Zoellner', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}]",Journal of traumatic stress,['10.1002/jts.22744']
2082,34715244,Does odour priming influence snack choice? - An eye-tracking study to understand food choice processes.,"Awareness of food sensory cues in our surroundings may influence our eating behaviour in different ways. For example, exposure to non-consciously perceived odours may influence food choice but not appetite. Moreover, this type of exposure may mainly influence the food choice of starters or desserts but not of main courses. This infers that odour priming may influence impulsive or rewarding food choice but may not overrule our habits concerning the choice of a main meal. It is crucial to understand the role of odour priming on eating behaviour and how people can be steered towards healthier options. Implicit measures, such as visual attention, may be central to understand the food choice process. Therefore, we aimed to determine how non-conscious exposure to odours affect congruent snack choice (i.e. with similar taste characteristics) and whether this is modulated by visual attention. A total of 53 healthy young adults took part in a cross-over study which consisted of two test sessions. In each test session, they were non-consciously exposed to an odour that is associated to a sweet or savoury food. Visual attention was investigated by means of a wearable eye-tracker and subsequent snack choice was (covertly) measured. Our results showed that congruent snacks were fixated on first. However, sweet snacks were fixated on more frequently, and for a longer period of time, and were chosen most often, irrespective of the type of odour exposure. Our findings indicate that odour priming might steer the initial orientation towards congruent foods, but other factors (e.g. cognitive) may overrule its effect on the final choice.",2021,It is crucial to understand the role of odour priming on eating behaviour and how people can be steered towards healthier options.,['53 healthy young adults'],[],['Visual attention'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0589102', 'cui_str': 'Visual attention'}]",53.0,0.0220818,It is crucial to understand the role of odour priming on eating behaviour and how people can be steered towards healthier options.,"[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Morquecho-Campos', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, 6708 WE, Wageningen, the Netherlands.'}, {'ForeName': 'Ina M', 'Initials': 'IM', 'LastName': 'Hellmich', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, 6708 WE, Wageningen, the Netherlands.'}, {'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'Zwart', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, 6708 WE, Wageningen, the Netherlands.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'de Graaf', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, 6708 WE, Wageningen, the Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Boesveldt', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, 6708 WE, Wageningen, the Netherlands. Electronic address: sanne.boesveldt@wur.nl.'}]",Appetite,['10.1016/j.appet.2021.105772']
2083,34715530,Socio-demographic factors related to parent engagement in the NICU and the impact of the SENSE program.,"BACKGROUND


Early parent engagement in the neonatal intensive care unit (NICU) is important for both parent and infant mental health and for improving developmental outcomes. It remains unclear how different programs, such as the Supporting and Enhancing NICU Sensory Experiences (SENSE) program, may empower parents from various socio-demographic groups to engage in the NICU. An improved understanding could aid in individualizing interventions for those at the highest risk for health disparities.
AIMS


This exploratory study, which was part of a larger study, sought to explore 1) socio-demographic factors related to parent presence and engagement in the NICU and 2) if the SENSE program related to increased parent presence and engagement among different socio-demographic groups.
METHODS


Seventy parent-infant dyads (born ≤ 32 weeks gestation) were randomized to SENSE programming (parent education and age-appropriate, positive sensory interventions for parents to conduct with their infants every day of hospitalization) or standard care after admission to the NICU. The amount of parent presence and participation in sensory activities was tracked using bedside logs, nursing records, and research team documentation.
RESULTS


Being married (p = 0.048; p = 0.01), having private insurance (p < 0.001; p = 0.01), and having fewer children (p = 0.004; p = 0.03) related to more parent presence and engagement respectively. Parents who were Black had less presence and engagement in the NICU (p = 0.04; p = 0.02). Participation in the SENSE program was related to more parent presence and engagement among younger mothers (p = 0.002; p ≤0.001) and among parents living farther distances from the hospital (p < 0.001; p = 0.004).
CONCLUSION


Programming, such as the SENSE program, can improve parent engagement in the NICU among high-risk groups.",2021,"Participation in the SENSE program was related to more parent presence and engagement among younger mothers (p = 0.002; p ≤0.001) and among parents living farther distances from the hospital (p < 0.001; p = 0.004).
","['Seventy parent-infant dyads (born ≤ 32\xa0weeks gestation', 'Being married (p\xa0']","['SENSE programming (parent education and age-appropriate, positive sensory interventions for parents to conduct with their infants every day of hospitalization) or standard care after admission to the NICU']",['having private insurance'],"[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0555047', 'cui_str': 'Married'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]",,0.0244485,"Participation in the SENSE program was related to more parent presence and engagement among younger mothers (p = 0.002; p ≤0.001) and among parents living farther distances from the hospital (p < 0.001; p = 0.004).
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Whitehill', 'Affiliation': 'School of Medicine, University College Dublin, Belfield, Dublin 4, Ireland; Institute for Public Health, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ""Department of Quality, Safety and Practice Excellence, St. Louis Children's Hospital, St. Louis, MO, USA.""}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Colditz', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Le', 'Affiliation': 'Program in Occupational Therapy, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Kellner', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Pineda', 'Affiliation': 'Program in Occupational Therapy, Washington University School of Medicine, St. Louis, MO, USA; Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA; Department of Pediatrics, Keck School of Medicine, Los Angeles, CA, USA; Gehr Family Center for Health Systems Science and Innovation, University of Southern California, Los Angeles, CA, USA; Center for the Changing Family, University of Southern California, Los Angeles, CA, USA. Electronic address: pinedaro@usc.edu.'}]",Early human development,['10.1016/j.earlhumdev.2021.105486']
2084,34718145,Combined inorganic nitrate/nitrite supplementation blunts α-mediated vasoconstriction during exercise in patients with type 2 diabetes.,"AIMS


Patients with type 2 diabetes mellitus (T2DM) have reduced vasodilatory responses during exercise partially attributable to low nitric oxide (NO) levels. Low NO contributes to greater α-adrenergic mediated vasoconstriction in contracting skeletal muscle. We hypothesized boosting NO bioavailability via 8wks of active beetroot juice (BR A , 4.03 mmol nitrate, 0.29 mmol nitrite, n = 19) improves hyperemia, via reduced α-mediated vasoconstriction, during handgrip exercise relative to nitrate/nitrite-depleted beetroot juice (BR P , n = 18) in patients with T2DM.
METHODS


Forearm blood flow (FBF) and vascular conductance (FVC) were calculated at rest and during handgrip exercise (20%max, 20contractions·min -1 ). Phenylephrine (α 1 -agonist) and dexmedetomidine (α 2 -agonist) were infused intra-arterially during independent trials to determine the influence of α-mediated vasoconstriction on exercise hyperemia. Vasoconstriction was quantified as the percent-reduction in FVC during α-agonist infusion, relative to pre-infusion, as well as the absolute change in %FVC during exercise relative to the respective rest trial (magnitude of sympatholysis).
RESULTS


ΔFBF (156 ± 69 to 175 ± 73 ml min -1 ) and ΔFVC (130 ± 54 to 156 ± 63 ml min -1 ·100 mmHg -1 , both P < 0.05) during exercise were augmented following BR A , but not BR P  (P = 0.96 and 0.51). Phenylephrine-induced vasoconstriction during exercise was blunted following BR A  (-17.1 ± 5.9 to -12.6 ± 3.1%, P < 0.01), but not BR P  (P = 0.58) supplementation; the magnitude of sympatholysis was unchanged by either (beverage-by-time P = 0.15). BR A  supplementation reduced dexmedetomidine-induced vasoconstriction during exercise (-23.3 ± 6.7 to -19.7 ± 5.2%) and improved the corresponding magnitude of sympatholysis (25.3 ± 11.4 to 34.4 ± 15.5%, both P < 0.05).
CONCLUSIONS


BR A  supplementation improves the hyperemic and vasodilatory responses to exercise in patients with T2DM which appears to be attributable to reduced α-adrenergic mediated vasoconstriction in contracting skeletal muscle.",2021,"Phenylephrine-induced vasoconstriction during exercise was blunted following BR A  nitrate (-17.1±5.9 to -12.6±3.1%, P<0.01), but not BR P  placebo (P=0.58) supplementation; the magnitude of sympatholysis was unchanged by either (beverage-by-time P=0.15).","['Patients with type 2 diabetes mellitus (T2DM', 'patients with T2DM', 'patients with type 2 diabetes']","['dexmedetomidine', 'Phenylephrine (α 1 -agonist) and dexmedetomidine (α 2 -agonist', 'BR A  supplementation', 'Phenylephrine', 'placebo', 'Combined inorganic nitrate/nitrite supplementation']","['Forearm blood flow (FBF) and vascular conductance (FVC', 'hyperemic and vasodilatory responses', 'Vasoconstriction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}]","[{'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}]",,0.0746966,"Phenylephrine-induced vasoconstriction during exercise was blunted following BR A  nitrate (-17.1±5.9 to -12.6±3.1%, P<0.01), but not BR P  placebo (P=0.58) supplementation; the magnitude of sympatholysis was unchanged by either (beverage-by-time P=0.15).","[{'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Bock', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'Department of Anesthesia, Carver College of Medicine, University of Iowa, 200 Hawkins Dr, Iowa City, IA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Feider', 'Affiliation': 'Department of Anesthesia, Carver College of Medicine, University of Iowa, 200 Hawkins Dr, Iowa City, IA, USA.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hanada', 'Affiliation': 'Department of Anesthesia, Carver College of Medicine, University of Iowa, 200 Hawkins Dr, Iowa City, IA, USA.'}, {'ForeName': 'Darren P', 'Initials': 'DP', 'LastName': 'Casey', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, University of Iowa, Iowa City, IA, USA; Abboud Cardiovascular Research Center, University of Iowa, 285 Newton Rd, Iowa City, IA, USA; Fraternal Order of Eagles Diabetes Research Center, University of Iowa, Iowa City, IA, 169 Newton Rd, IA, USA. Electronic address: darren-casey@uiowa.edu.'}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2021.10.006']
2085,34717968,Menthol-induced activation of TRPM8 receptors increases cutaneous blood flow across the dermatome.,"Topical menthol-based analgesics increase skin blood flow (SkBF) through transient receptor potential melastatin 8 (TRPM8) receptor-dependent activation of sensory nerves and endothelium-derived hyperpolarization factors. It is unclear if menthol-induced TRPM8 activation mediates a reflex change in SkBF across the dermatome in an area not directly treated with menthol. The purpose of this study was to determine the effects of localized topical menthol application on SkBF across a common dermatome. We hypothesized that SkBF would be increased with menthol at the site of application and across the dermatome (contralateral limb) through a spinal reflex mechanism. In a double blind, placebo controlled, cross-over design, 15 healthy participants (7 men; age = 22 ± 1 yrs) were treated with direct application (3 ml over 8 × 13 cm) of 5% menthol gel (Biofreeze™) or placebo gel on the L4 dermatome, separated by 48 h. Red blood cell flux was measured using laser Doppler flowmetry over the area of application, on the contralateral leg of the same dermatome, and in a separate dermatome (L5/S1) to serve as control. Cutaneous vascular conductance was calculated for each measurement site (CVC = flux/MAP). At baseline there were no differences in CVC between menthol and placebo gels, or among sites (all p > 0.05). After 30 ± 6 min, CVC increased at the treated site with menthol (0.12 ± 0.02 vs. 1.36 ± 0.19 flux/mm Hg, p < 0.01) but not the placebo (0.10 ± 0.01 vs. 0.18 ± 0.04 flux/mm Hg, p = 0.91). There was a modest increase in CVC at the contralateral L4 dermatome with menthol gel (0.16 ± 0.04 vs. 0.29 ± 0.06 flux/mm Hg, p < 0.01), but not placebo (0.11 ± 0.02 vs. 0.15 ± 0.03 flux/mm Hg, p = 0.41). There was no effect on SkBF from either treatments at the L5/S1 control dermatome (both, p > 0.05), suggesting the lack of a systemic response. In conclusion, menthol containing topical analgesic gels increased SkBF at the treated site, and modestly throughout the dermatome. These data suggest menthol-induced activation of the TRPM8 receptors induces an increase in SkBF across the area of common innervation through a localized spinal reflex mechanism.",2021,"At baseline there were no differences in CVC between menthol and placebo gels, or among sites (all p > 0.05).",['15 healthy participants (7 men; age\xa0=\xa022\xa0±\xa01\xa0yrs'],"['Topical menthol-based analgesics', 'placebo', 'localized topical menthol application', 'direct application (3\xa0ml over 8\xa0×\xa013\xa0cm) of 5% menthol gel (Biofreeze™) or placebo gel on the L4 dermatome, separated by 48\xa0h. Red blood cell flux was measured using laser Doppler flowmetry']","['Cutaneous vascular conductance', 'CVC', 'skin blood flow (SkBF', 'SkBF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3214746', 'cui_str': 'Menthol-containing product in cutaneous dose form'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1815268', 'cui_str': 'Biofreeze'}, {'cui': 'C0448746', 'cui_str': 'Dermatome of fourth lumbar nerve'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",15.0,0.068839,"At baseline there were no differences in CVC between menthol and placebo gels, or among sites (all p > 0.05).","[{'ForeName': 'Gabrielle A', 'Initials': 'GA', 'LastName': 'Dillon', 'Affiliation': 'Noll Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA; Center for Healthy Aging, The Pennsylvania State University, University Park, PA, USA. Electronic address: gad27@psu.edu.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Lichter', 'Affiliation': 'Noll Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Lacy M', 'Initials': 'LM', 'LastName': 'Alexander', 'Affiliation': 'Noll Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA; Center for Healthy Aging, The Pennsylvania State University, University Park, PA, USA.'}]",Microvascular research,['10.1016/j.mvr.2021.104271']
2086,34715388,Comparison of pericapsular nerve group (PENG) block with fascia iliaca compartment block (FICB) for pain control in hip fractures: A double-blind prospective randomized controlled clinical trial.,"BACKGROUND


Fascia iliaca compartment block (FICB) is a common regional analgesic strategy in hip fracture surgery but, recently it has been suggested that FICB may not provide enough analgesia. Pericapsular nerve group block (PENG) is a novel method for hip analgesia which its efficacy is not well established yet. The aim of this study was to the effect of the PENG block in the control of the hip fracture pain as well as to compare the effectiveness of the PENG compared with FICB.
HYPOTHESIS


The hypothesis of this study was that the PENG block could be a good alternative to the FICB in hip fracture analgesia.
MATERIALS AND METHODS


This randomized controlled clinical trial was conducted in the Imam- Hossein Hospital, Tehran, Iran; between 2018 and 2019. Hip fracture patients were randomly divided into two groups; Group A (n=22) received FICB and Group B (n=30) received PENG block.
RESULTS


There was no significant difference between VAS score before blocks procedure between two groups (p=0.37). After 15minutes of blocks and after 12hours of post-surgery, VAS score significantly reduced in the PENG block group compared with the FICB group (p=0.031; p=0.021, respectively). The first time of the analgesic consumption after surgery was significantly longer in the PENG block compared with the FCIB (p=0.007). Compared with the FICB group, the total dose of morphine consumption during 24hours significantly reduced in the PENG block (p=0.008).
CONCLUSION


PENG block is a good method in hip fractures analgesia and provides better analgesia than FICB. However, further studies with larger sample sizes are required to validate the efficacy and superiority of the PENG blocks over conventional techniques.
LEVEL OF EVIDENCE


I.",2021,"After 15 minutes of blocks and after 12 hours of post-surgery, VAS score significantly reduced in the PENG block group compared with the FICB group (P=0.031; P= 0.021, respectively).","['hip fracture surgery', 'hip fractures', 'Imam- Hossein Hospital, Tehran, Iran; between 2018 and 2019', 'Hip fracture patients']","['FICB', 'PENG block', 'Pericapsular nerve group (PENG) block with fascia iliaca compartment block (FICB', 'Fascia iliaca compartment block (FICB', 'FICB and Group B', 'PENG', 'Pericapsular nerve group block (PENG']","['analgesic consumption', 'VAS score', 'total dose of morphine consumption']","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",,0.0711195,"After 15 minutes of blocks and after 12 hours of post-surgery, VAS score significantly reduced in the PENG block group compared with the FICB group (P=0.031; P= 0.021, respectively).","[{'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Mosaffa', 'Affiliation': 'Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Manafi Rasi', 'Affiliation': 'Department of Orthopedics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Samadpour', 'Affiliation': 'Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Memary', 'Affiliation': 'Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mirkheshti', 'Affiliation': 'Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: drmirkheshti@gmail.com.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2021.103135']
2087,34717013,"The effect of two retraining programs, barefoot running vs increasing cadence, on kinematic parameters: A randomized controlled trial.","The aim of this study was to compare the effects of two 10-week non-laboratory-based running retraining programs on foot kinematics and spatiotemporal parameters in recreational runners. One hundred and three recreational runners (30 ± 7.2 years old, 39% females) were randomly assigned to either: a barefoot retraining group (BAR) with 3 sessions/week over 10 weeks, a cadence retraining group (CAD) who increased cadence by 10% again with 3 sessions/week over 10 weeks and a control group (CON) who did not perform any retraining. The footstrike pattern, footstrike angle (FSA), and spatial-temporal variables at comfortable and high speeds were measured using 2D/3D photogrammetry and a floor-based photocell system. A 3 × 2 ANOVA was used to compare between the groups and 2 time points. The FSA significantly reduced at the comfortable speed by 5.81° for BAR (p < 0.001; Cohen's d = 0.749) and 4.81° for CAD (p = 0.002; Cohen's d = 0.638), and at high speed by 6.54° for BAR (p < 0.001; Cohen's d = 0.753) and by 4.71° for CAD (p = 0.001; Cohen's d = 0.623). The cadence significantly increased by 2% in the CAD group (p = 0.015; Cohen's d = 0.344) at comfortable speed and the BAR group showed a 1.7% increase at high speed. BAR and CAD retraining programs showed a moderate effect for reducing FSA and rearfoot prevalence, and a small effect for increasing cadence. Both offer low-cost and feasible tools for gait modification within recreational runners in clinical scenarios.",2021,"The FSA significantly reduced at the comfortable speed by 5.81° for BAR (p < 0.001; Cohen's d = 0.749) and 4.81° for CAD (p = 0.002; Cohen's d = 0.638), and at high speed by 6.54° for BAR (p < 0.001; Cohen's d = 0.753) and by 4.71° for CAD (p = 0.001; Cohen's d = 0.623).","['recreational runners', 'One hundred and three recreational runners (30 ± 7.2 years old, 39% females']","['laboratory based running retraining programs', 'CAD', 'BAR and CAD retraining programs', 'cadence retraining group (CAD) who increased cadence by 10% again with 3 sessions/week over 10 weeks and a control group (CON) who did not perform any retraining', 'barefoot retraining group (BAR', 'retraining programs, barefoot running']","['foot kinematics and spatiotemporal parameters', 'footstrike pattern, footstrike angle (FSA) and spatial-temporal variables at comfortable and high speeds', 'FSA and rearfoot prevalence']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",103.0,0.0266177,"The FSA significantly reduced at the comfortable speed by 5.81° for BAR (p < 0.001; Cohen's d = 0.749) and 4.81° for CAD (p = 0.002; Cohen's d = 0.638), and at high speed by 6.54° for BAR (p < 0.001; Cohen's d = 0.753) and by 4.71° for CAD (p = 0.001; Cohen's d = 0.623).","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Molina-Molina', 'Affiliation': 'Campus Universitario, Universidad San Jorge, Autov A23 km 299, Villanueva de Gállego, Zaragoza, 50830, Spain.'}, {'ForeName': 'Pedro Ángel', 'Initials': 'PÁ', 'LastName': 'Latorre-Román', 'Affiliation': 'Department of Didactics of Corporal Expression, Universidad de Jaén, Jaén, Spain.'}, {'ForeName': 'Elia', 'Initials': 'E', 'LastName': 'Mercado-Palomino', 'Affiliation': 'Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Delgado-García', 'Affiliation': 'Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Richards', 'Affiliation': 'Allied Health Research Unit, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Víctor Manuel', 'Initials': 'VM', 'LastName': 'Soto-Hermoso', 'Affiliation': 'Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.14091']
2088,34714252,Moderators of the Effect of a Self-directed Digitally Delivered Exercise Program for People With Knee Osteoarthritis: Exploratory Analysis of a Randomized Controlled Trial.,"BACKGROUND


A 24-week self-directed digitally delivered intervention was found to improve pain and function in people with knee osteoarthritis (OA). However, it is possible that this intervention may be better suited to certain subgroups of people with knee OA compared to others.
OBJECTIVE


The aim of this study was to explore whether certain individual baseline characteristics moderate the effects of a self-directed digitally delivered intervention on changes in pain and function over 24 weeks in people with knee OA.
METHODS


An exploratory analysis was conducted on data from a randomized controlled trial involving 206 people with a clinical diagnosis of knee OA. This trial compared a self-directed digitally delivered intervention comprising of web-based education, exercise, and physical activity program supported by automated exercise behavior change mobile phone text messages to web-based education alone (control). The primary outcomes were changes in overall knee pain (assessed on an 11-point numerical rating scale) and physical function (assessed using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale [WOMAC]) at 24 weeks. Five baseline patient characteristics were selected as the potential moderators: (1) number of comorbidities, (2) number of other painful joints, (3) pain self-efficacy, (4) exercise self-efficacy, and (5) self-perceived importance of exercise. Separate linear regression models for each primary outcome and each potential moderator were fit, including treatment group, moderator, and interaction between treatment group and moderator, adjusting for the outcome at baseline.
RESULTS


There was evidence that pain self-efficacy moderated the effect of the intervention on physical function compared to the control at 24 weeks (interaction P=.02). Posthoc assessment of the mean change in WOMAC function by treatment arm showed that each 1-unit increase in baseline pain self-efficacy was associated with a 1.52 (95% CI 0.27 to 2.78) unit improvement in the control group. In contrast, a reduction of 0.62 (95% CI -1.93 to 0.68) units was observed in the intervention group with each unit increase in pain self-efficacy. There was only weak evidence that pain self-efficacy moderated the effect of the intervention on pain and that number of comorbidities, number of other painful joints, exercise self-efficacy, or exercise importance moderated the effect of the intervention on pain or function.
CONCLUSIONS


With the exception of pain self-efficacy, which moderated changes in function but not pain, we found limited evidence that our selected baseline patient characteristics moderated intervention outcomes. This indicates that people with a range of baseline characteristics respond similarly to the unsupervised digitally delivered exercise intervention. As these findings are exploratory in nature, they require confirmation in future studies.",2021,There was evidence that pain self-efficacy moderated the effect of the intervention on physical function compared to the control at 24 weeks (interaction P=.02).,"['people with knee OA', 'people with knee osteoarthritis (OA', '206 people with a clinical diagnosis of knee OA', 'People With Knee Osteoarthritis']","['self-directed digitally delivered intervention', 'Self-directed Digitally Delivered Exercise Program', 'self-directed digitally delivered intervention comprising of web-based education, exercise, and physical activity program supported by automated exercise behavior change mobile phone text messages to web-based education alone (control']","['physical function', 'overall knee pain (assessed on an 11-point numerical rating scale) and physical function (assessed using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale [WOMAC', 'pain and that number of comorbidities, number of other painful joints, exercise self-efficacy', 'pain and function', 'number of comorbidities, (2) number of other painful joints, (3) pain self-efficacy, (4) exercise self-efficacy, and (5) self-perceived importance of exercise', 'WOMAC function', 'pain or function', 'pain self-efficacy', 'baseline pain self-efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",206.0,0.0751638,There was evidence that pain self-efficacy moderated the effect of the intervention on physical function compared to the control at 24 weeks (interaction P=.02).,"[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Nelligan', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McManus', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lamb', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Parkville, Australia.'}]",Journal of medical Internet research,['10.2196/30768']
2089,34706964,Dehydroepiandrosterone (DHEA) role in enhancement and maintenance of implantation (DREAM): randomised double-blind placebo-controlled trial-study protocol.,"INTRODUCTION


Dehydroepiandrosterone (DHEA) is an important precursor of androgen and has been studied and researched extensively for improving the various outcome measures of ovarian stimulation in women with advanced age or poor ovarian response. Androgens also play an important role in the enhancement of endometrial and decidual function by regulating both the transcriptome and secretome of the endometrial stromal cells and have a positive effect on various factors like insulin-like growth factor binding protein 1, homeobox genes (HOXA10, HOXA11), secreted phosphoprotein 1, prolactin which are necessary for implantation. It is well-known that the circulating 'precursor pool' of DHEA declines with age more so in poor ovarian reserve patients and exogenous supplementation may be beneficial in such cases. This double-blinded randomised controlled trial (RCT) aims to test the hypothesis whether transient targeted supplementation of DHEA as an adjuvant to progesterone in frozen embryo transfer (FET) cycles, for women with low serum testosterone, helps in improving live birth rate.
METHODS AND ANALYSIS


This study is planned as a double-blinded, placebo-controlled randomised trial and the sample size, calculated for the primary outcome measure-live birth rate, is 140. All participants will be having a flexible antagonist protocol for controlled ovarian stimulation and an elective freeze-all policy for the embryos as per the hospital protocol after written informed consent. For FET, the endometrium will be prepared by hormone replacement treatment protocol. During the FET cycle, the intervention group will be receiving DHEA 25 mg two times a day for 15 days from the day of starting progesterone supplementation and the control group will be receiving a placebo.
ETHICS AND DISSEMINATION


The approval of the study was granted by the Clinical Trials Registry-India and the Institutional Ethical Committee of CRAFT Hospital and Research Center. All participants will provide written informed consent before being randomised into allocated treatment groups. The results will be disseminated to doctors and patients through conference presentations, peer-reviewed publications, social media and patient information booklets.
TRIAL REGISTRATION NUMBERS


CTRI/2020/06/025918; ECR/1044/Inst/KL/2018.",2021,All participants will be having a flexible antagonist protocol for controlled ovarian stimulation and an elective freeze-all policy for the embryos as per the hospital protocol after written informed consent.,"['women with low serum testosterone, helps in improving live birth rate', 'women with advanced age or poor ovarian response']","['Dehydroepiandrosterone (DHEA', 'placebo']",['live birth rate'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}]",,0.937049,All participants will be having a flexible antagonist protocol for controlled ovarian stimulation and an elective freeze-all policy for the embryos as per the hospital protocol after written informed consent.,"[{'ForeName': 'Majiyd Abdul', 'Initials': 'MA', 'LastName': 'Noushin', 'Affiliation': 'Reproductive Medicine, CRAFT Hospital, Trichur, Kerala, India.'}, {'ForeName': 'Apeksha', 'Initials': 'A', 'LastName': 'Sahu', 'Affiliation': 'Reproductive Medicine, CRAFT Hospital, Trichur, Kerala, India drapekshargkar@gmail.com.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Reproductive Medicine, CRAFT Hospital, Trichur, Kerala, India.'}, {'ForeName': 'Sankalp', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Reproductive Medicine, CRAFT Hospital, Trichur, Kerala, India.'}, {'ForeName': 'Kannamannadiar', 'Initials': 'K', 'LastName': 'Jayaprakasan', 'Affiliation': 'Nottingham University Research and Treatment Unit in Reproduction (NURTURE), University of Nottingham, Derby, UK.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Basheer', 'Affiliation': 'Reproductive Medicine, CRAFT Hospital, Trichur, Kerala, India.'}, {'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Ramachandran', 'Affiliation': 'Reproductive Medicine, CRAFT Hospital, Trichur, Kerala, India.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ashraf', 'Affiliation': 'Reproductive Medicine, CRAFT Hospital, Trichur, Kerala, India.'}]",BMJ open,['10.1136/bmjopen-2021-054251']
2090,34710778,Mothers are more sensitive to infant cues after breastfeeding compared to bottle-feeding with human milk.,"The belief that breastfeeding promotes maternal bonding is widely held by both the public and professional health organizations. Yet to our knowledge, all research examining the link between breastfeeding and maternal behavior in humans has been correlational, limiting our ability to draw causal conclusions. In many mammals, the hormone prolactin, which is central to milk production, rises in response to each breastfeeding session and promotes maternal sensitivity, yet there is a dearth of research in human mothers. To fill these research gaps, we randomly assigned 28 breastfeeding mothers to either breastfeed in the lab or feed their infants previously expressed breastmilk in a bottle before participating in a video-recorded free play session with their infant. Plasma prolactin was measured 40 min after the start of the feeding session and video observations were coded for maternal sensitivity. We found that women randomly assigned to breastfeed were more sensitive to infant cues than women randomly assigned to bottle-feed. Prolactin levels did not differ between feeding groups, although prolactin was positively correlated with maternal sensitivity. Our results suggest that feeding milk directly from the breast (compared to bottle-feeding) increases maternal sensitivity towards infants, at least in the short term.",2021,We found that women randomly assigned to breastfeed were more sensitive to infant cues than women randomly assigned to bottle-feed.,"['human mothers', '28 breastfeeding mothers to either']",['breastfeed in the lab or feed their infants previously expressed breastmilk in a bottle before participating in a video-recorded free play session with their infant'],"['Prolactin levels', 'maternal sensitivity', 'Plasma prolactin']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0857712', 'cui_str': 'Plasma prolactin'}]",28.0,0.0146527,We found that women randomly assigned to breastfeed were more sensitive to infant cues than women randomly assigned to bottle-feed.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hahn-Holbrook', 'Affiliation': 'Department of Psychology, University of California, Merced, CA, United States of America. Electronic address: jhahn-holbrook@ucmerced.edu.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Little', 'Affiliation': 'Nurturely, San Diego, CA, United States of America.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Abbott', 'Affiliation': 'Department of Health Sciences, Chapman University, Orange, CA, United States of America.'}]",Hormones and behavior,['10.1016/j.yhbeh.2021.105047']
2091,34715486,"The effectiveness of the combined transcranial direct current stimulation (tDCS) and tailor-made notched music training (TMNMT) on psychoacoustic, psychometric, and cognitive indices of tinnitus patients.","PURPOSE


Tinnitus network(s) consists of pathways in the auditory cortex, frontal cortex, and the limbic system. The cortical hyperactivity caused by tinnitus may be suppressed by neuromodulation techniques. Due to the lack of definitive treatment for tinnitus and limited usefulness of the individual methods, in this study, a combination of transcranial direct current stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) and tailor-made notched music training (TMNMT) was used.
MATERIAL AND METHODS


In this descriptive-analytic study, 26 patients with chronic unilateral tinnitus of the right ear were randomly divided into the clinical trial group (CTG) and the control group (CG). In both groups, six sessions of tDCS with 2 mA intensity for 20 min, with anode on F4 and cathode on F3, were conducted. Simultaneous with tDCS sessions, and based on TMNMT, the participant was asked to listen passively for 120 min/day, to a CD containing her/his favorite music with a proper notch applied in its spectrum according to the individual's tinnitus The treatment outcome was measured by, psychoacoustic (loudness-matching), psychometric (awareness, loudness and annoyance Visual Analogue Scale (VAS) scores, and Tinnitus Handicap Inventory (THI)) scores, and cognitive assessments (randomized dichotic digits test (RDDT) and dichotic auditory-verbal memory test (DAVMT)). Repeated measurement test was used for statistical analyses.
RESULTS


In the CTG, the tinnitus loudness and annoyance VAS scores, and THI were reduced significantly (p = 0.001). In addition, the DAVMT and RDDT scores were enhanced (p = 0.001). Such changes were not observed in the CG (p > 0.05).
CONCLUSION


The combination of tDCS and TMNMT led to a reduction in the loudness, awareness, annoyance, and also disability induced by tinnitus in CTG. Furthermore, this method showed an improvement of cognitive functions (auditory divided attention, selective attention and working memory) in the CTG.",2021,"Furthermore, this method showed an improvement of cognitive functions (auditory divided attention, selective attention and working memory) in the CTG.","['tinnitus patients', '26 patients with chronic unilateral tinnitus of the right ear']","['transcranial direct current stimulation (tDCS', ""CD containing her/his favorite music with a proper notch applied in its spectrum according to the individual's tinnitus"", 'tDCS and TMNMT', 'combined transcranial direct current stimulation (tDCS) and tailor-made notched music training (TMNMT']","['DAVMT and RDDT scores', 'psychoacoustic, psychometric, and cognitive indices', 'cognitive functions (auditory divided attention, selective attention and working memory', 'psychoacoustic (loudness-matching), psychometric (awareness, loudness and annoyance Visual Analogue Scale (VAS) scores, and Tinnitus Handicap Inventory (THI)) scores, and cognitive assessments (randomized dichotic digits test (RDDT) and dichotic auditory-verbal memory test (DAVMT', 'tinnitus loudness and annoyance VAS scores, and THI']","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0229298', 'cui_str': 'Right ear structure'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033877', 'cui_str': 'Psychoacoustics'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0589101', 'cui_str': 'Divided attention'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0272238', 'cui_str': 'Transient hypogammaglobulinemia of infancy'}]",26.0,0.0091296,"Furthermore, this method showed an improvement of cognitive functions (auditory divided attention, selective attention and working memory) in the CTG.","[{'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Moossavi', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Mehrkian', 'Affiliation': 'Department of Audiology, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Sirvan', 'Initials': 'S', 'LastName': 'Najafi', 'Affiliation': 'Department of Audiology, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: sirwannajafi@gmail.com.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.103274']
2092,34717200,Influence of intermittent pneumatic compression on foot sensation and balance control in chemotherapy-induced peripheral neuropathy patients.,"BACKGROUND


Chemotherapy-induced peripheral neuropathy, a side effect of cancer treatment, presents several issues to patients, including reduced sensation and increased fall risk. Previously, massage therapy has been shown to improve chemotherapy-induced peripheral neuropathy symptoms, possibly through increased blood flow. A custom built intermittent pneumatic compression device, previously shown to increase lower leg blood flow, was tested as a plausible treatment modality.
METHODS


Seven cancer survivors suffering from chemotherapy-induced peripheral neuropathy were recruited. Foot sensation (Semmes-Weinstein test) as well as static (dual and tandem stance) and dynamic (timed-up-and-go) balance control tests were performed both pre and post a 5-min intermittent pneumatic compression intervention. Self-reported feedback was provided by participants following testing and 24-h later.
FINDINGS


Five participants reported positive changes in their feet immediately following intermittent pneumatic compression treatment while four of those participants reported positive changes up to 24 h after intervention. Foot sensation was unchanged regardless of location tested (P ≥ 0.23). Postural sway path length and sway area were unchanged following intervention during dual stance (P ≥ 0.14), but path length was significantly reduced (~19.9%) following intervention during tandem stance (P = 0.033). Timed-up-and-go duration was also significantly reduced (~7.0%, P = 0.012).
INTERPRETATION


Overall, these findings demonstrate that intermittent pneumatic compression may be a plausible treatment modality for improving self-reported foot sensation as well as static and dynamic balance control. As a pilot study, this study provides sufficient context for further research exploring the efficacy of intermittent pneumatic compression as a treatment using a randomized control trial design.",2021,"Postural sway path length and sway area were unchanged following intervention during dual stance (P ≥ 0.14), but path length was significantly reduced (~19.9%) following intervention during tandem stance (P = 0.033).","['chemotherapy-induced peripheral neuropathy patients', 'Seven cancer survivors suffering from chemotherapy-induced peripheral neuropathy were recruited']","['massage therapy', 'intermittent pneumatic compression']","['Postural sway path length and sway area', 'lower leg blood flow', 'Foot sensation', 'Timed-up-and-go duration', 'path length', 'foot sensation and balance control']","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",7.0,0.00662003,"Postural sway path length and sway area were unchanged following intervention during dual stance (P ≥ 0.14), but path length was significantly reduced (~19.9%) following intervention during tandem stance (P = 0.033).","[{'ForeName': 'Taylor B', 'Initials': 'TB', 'LastName': 'Winberg', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Hedge', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, University of Waterloo, Waterloo, Ontario, Canada; Schlegel-University of Waterloo Research Institute for Aging, Waterloo, Ontario, Canada.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Peterson', 'Affiliation': 'Department of Mechanical and Mechatronics Engineering, Faculty of Engineering, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Hughson', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, University of Waterloo, Waterloo, Ontario, Canada; Schlegel-University of Waterloo Research Institute for Aging, Waterloo, Ontario, Canada.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Laing', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, University of Waterloo, Waterloo, Ontario, Canada; Schlegel-University of Waterloo Research Institute for Aging, Waterloo, Ontario, Canada. Electronic address: actlaing@uwaterloo.ca.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2021.105512']
2093,34715908,Predictors of long-term clinical response in patients with non-radiographic axial spondyloarthritis receiving certolizumab pegol.,"BACKGROUND


Identification of predictive clinical factors of long-term treatment response may contribute to improved management of non-radiographic axSpA (nr-axSpA) patients. This analysis aims to identify whether any baseline characteristics or Week 12 clinical outcomes in nr-axSpA patients with elevated C-reactive protein (CRP) and/or sacroiliitis on magnetic resonance imaging (MRI) enrolled in the C-axSpAnd study are predictive of achieving clinical response after 1 year of certolizumab pegol (CZP).
METHODS


C-axSpAnd (NCT02552212) was a phase 3, multicentre study, including a 52-Week double-blind, placebo-controlled period. Enrolled patients were randomised to CZP 200 mg Q2W or placebo. Predictors of Week 12 (CZP group only) and Week 52 clinical response were identified using a multivariate stepwise logistic regression analysis. Response variables included Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI), Assessment of SpondyloArthritis International Society 40% response (ASAS40), Bath Ankylosing Spondylitis Disease Activity Index 50% response (BASDAI50) and ASDAS inactive disease (ASDAS-ID). Predictive factors assessed included demographic and baseline characteristics and clinical outcomes at Week 12. A p-value <0.05 was required for forward selection into the model and p ≥0.1 for backward elimination. Missing data or values collected after switching to open-label treatment were accounted for using non-responder imputation. Sensitivity analyses accounted for patients with changes in non-biologic background medication.
RESULTS


Of 317 enrolled patients, 159 and 158 were randomised to CZP and placebo, respectively. Younger age and male sex were identified as predictors of Week 12 response across all assessed efficacy outcomes in CZP-treated patients. Consistent predictors of Week 52 response, measured by ASDAS-MI, ASAS40 and BASDAI50, included human leukocyte antigen (HLA)-B27 positivity and sacroiliitis on MRI at baseline. MRI positivity was also predictive of achieving ASDAS-ID at Week 52. Sensitivity analyses were generally consistent with the primary analysis. In placebo-treated patients, no meaningful predictors of Week 52 response were identified.
CONCLUSIONS


In this 52-Week, placebo-controlled study in nr-axSpA patients with elevated CRP and/or active sacroiliitis on MRI at baseline, MRI sacroiliitis and HLA-B27 positivity, but not elevated CRP or responses at Week 12, were predictive of long-term clinical response to CZP. Findings may support rheumatologists to identify patients suitable for TNFi treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02552212 . Registered on 15 September 2015.",2021,Younger age and male sex were identified as predictors of Week 12 response across all assessed efficacy outcomes in CZP-treated patients.,"['nr-axSpA patients with elevated C-reactive protein (CRP) and/or sacroiliitis on magnetic resonance imaging (MRI', 'patients with non-radiographic axial spondyloarthritis receiving certolizumab pegol', '317 enrolled patients, 159 and 158 were randomised to', 'patients with changes in non-biologic background medication', 'nr-axSpA patients with elevated CRP and/or active sacroiliitis on']","['CZP and placebo', 'placebo', 'CZP 200 mg Q2W or placebo']","['HLA)-B27 positivity and sacroiliitis on MRI', 'MRI positivity', 'ASDAS-MI, ASAS40 and BASDAI50, included human leukocyte antigen ', 'Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI), Assessment of SpondyloArthritis International Society 40% response (ASAS40), Bath Ankylosing Spondylitis Disease Activity Index 50% response (BASDAI50) and ASDAS inactive disease (ASDAS-ID', 'MRI at baseline, MRI sacroiliitis and HLA-B27 positivity']","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0574960', 'cui_str': 'Inflammation of sacroiliac joint'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}]","[{'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}, {'cui': 'C0574960', 'cui_str': 'Inflammation of sacroiliac joint'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019740', 'cui_str': 'HLA-B27 antigen'}]",317.0,0.240015,Younger age and male sex were identified as predictors of Week 12 response across all assessed efficacy outcomes in CZP-treated patients.,"[{'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Maksymowych', 'Affiliation': 'University of Alberta, Edmonton, Canada. walter.maksymowych@ualberta.ca.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kumke', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Simone E', 'Initials': 'SE', 'LastName': 'Auteri', 'Affiliation': 'UCB Pharma, Milan, Italy.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hoepken', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bauer', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rudwaleit', 'Affiliation': 'University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany.'}]",Arthritis research & therapy,['10.1186/s13075-021-02650-4']
2094,34687869,Effect of Benson and progressive muscle relaxation techniques on sleep quality after coronary artery bypass graft: A randomized controlled trial.,"OBJECTIVE


This study aimed to investigate the effect of Benson relaxation (BR) and progressive muscle relaxation (PMR) techniques on the sleep quality of patients undergoing coronary artery bypass graft (CABG) surgery.
METHOD


This study was a three-arm, parallel, randomized controlled trial. 120 patients who underwent CABG surgery at two academic hospitals in an urban area of Iran were randomly allocated into three groups (40 per group): the BR, PMR, and control groups. Patients in the BR and the PMR groups performed relevant exercises twice a day for four weeks. Sleep quality was measured before and immediately after the intervention using Pittsburgh Sleep Quality Index.
RESULTS


Within-group comparison in the BR (t = 3.51, p = 0.001) and the PMR (t = 4.58, p < 0.001) group showed that the overall sleep quality showed a significant improvement after the intervention when compared to baseline. The between-group comparison showed that both the BR and PMR groups showed significant improvements in subjective sleep quality (F = 3.75, p = 0.02), habitual sleep efficiency (F = 4.81, p = 0.01), and overall sleep quality (F = 5.53, p = 005) when compared to the control group after the intervention. However, no statistically significant differences were identified among the three study groups in terms of sleep latency, sleep duration, sleep disturbances, sleeping medication, and daytime dysfunction after the intervention (p > 0.05).
CONCLUSION


The study showed that a four-week program of both PMR and BR can be effective in the overall improvement of sleep quality in patients following CABG. Further research is required to replicate the findings of the present study.",2021,"However, no statistically significant differences were identified among the three study groups in terms of sleep latency, sleep duration, sleep disturbances, sleeping medication, and daytime dysfunction after the intervention (p > 0.05).
","['after coronary artery bypass graft', '120 patients who underwent CABG surgery at two academic hospitals in an urban area of Iran', 'patients undergoing coronary artery bypass graft (CABG) surgery']","['Benson relaxation (BR) and progressive muscle relaxation (PMR) techniques', 'Benson and progressive muscle relaxation techniques']","['Sleep quality', 'sleep latency, sleep duration, sleep disturbances, sleeping medication, and daytime dysfunction', 'overall sleep quality', 'sleep quality', 'subjective sleep quality', 'PMR', 'habitual sleep efficiency']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",120.0,0.0263547,"However, no statistically significant differences were identified among the three study groups in terms of sleep latency, sleep duration, sleep disturbances, sleeping medication, and daytime dysfunction after the intervention (p > 0.05).
","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Bagheri', 'Affiliation': 'School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: bagheri@shmu.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Moradi-Mohammadi', 'Affiliation': 'ICU department, Shahid Beheshti Hospital, Shahid Beheshti Boulevard, Azadegan Square, Qom, Iran. Electronic address: f.mohammadi186@yahoo.com.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Khosravi', 'Affiliation': 'School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: a.khosravi@shmu.ac.ir.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Ameri', 'Affiliation': 'School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: Amerimalihe@shmu.ac.ir.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Khajeh', 'Affiliation': 'School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: khajeh@shmu.ac.ir.'}, {'ForeName': 'Sally Wai-Chi', 'Initials': 'SW', 'LastName': 'Chan', 'Affiliation': 'Tung Wah College, Hong Kong. Electronic address: sallychan@twc.edu.hk.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abbasinia', 'Affiliation': 'Nursing faculty, Qom University of Medical Sciences, Qom, Iran. Electronic address: abbasyniamohammad@yahoo.com.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mardani', 'Affiliation': 'Nursing Care Research Center, Department of Medical Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. Electronic address: mardani.a@iums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102784']
2095,34724288,Kinetics of hepatitis B surface antigen in pregnant women with and without tenofovir disoproxil fumarate.,"Tenofovir disoproxil fumarate (TDF) is the preferred treatment to prevent mother-to-infant transmission in highly viremic HBV-infected women. Data on hepatitis B surface antigen (HBsAg) levels in pregnant women are lacking. We aimed to investigate prepartum and postpartum HBsAg kinetics and its correlation with HBV DNA in pregnant women. HBV-infected mothers with HBV DNA ≥7.5 log 10   IU/ml were tested for HBsAg and HBV DNA from baseline to 6 months postpartum. Of the 186 pregnant women with comparable baseline HBsAg and HBV DNA, 101 received TDF from the third trimester until 1 month postpartum. At delivery, TDF group had mildly lower HBsAg (4.32 ± 0.47 vs. 4.54 ± 0.35 log 10   IU/ml, p = .0004) and markedly lower HBV DNA (4.26 ± 0.97 vs. 8.11 ± 0.70 log 10   IU/ml, p < .0001) than the control group. In the TDF group, mean reduction of HBsAg and HBV DNA from baseline to delivery were 0.22 ± 0.38 and 3.96 ± 0.93 log 10   IU/ml. HBsAg reduction had a positive correlation (r = .309; p = .0017) with HBV DNA reduction, and was predictive of HBV DNA reduction ≥3 log 10   IU/ml (area under the receiver operating characteristic curve, 0.67; 95% confidence interval, 0.50-0.82). At 6 months postpartum, TDF and control group had comparable HBsAg and HBV DNA. In conclusion, HBsAg decreased slightly at delivery in pregnant women receiving TDF. For monitoring the effect of antiviral therapy during pregnancy, HBV DNA is a better marker than HBsAg. Our data provided valuable information regarding monitoring HBV-infected pregnant women using antiviral therapy.",2021,"IU/mL. HBsAg reduction had a positive correlation (r = 0.309; P = 0.0017) with HBV DNA reduction, and was predictive of HBV DNA reduction ≥","['186 pregnant women with comparable baseline HBsAg and HBV DNA, 101 received TDF from the third trimester until 1 month postpartum', 'pregnant women receiving TDF', 'pregnant women', 'Pregnant Women with and without', 'HBV-infected mothers with HBV DNA ≥ 7.5 log 10  IU']","['Tenofovir disoproxil fumarate (TDF', 'TDF', 'Tenofovir Disoproxil Fumarate']","['HBsAg and HBV DNA', 'mildly lower HBsAg', 'hepatitis B surface antigen (HBsAg', 'mean reduction of HBsAg and HBV DNA', 'HBsAg', 'HBV DNA reduction ≥']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4517859', 'cui_str': '7.5'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]","[{'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",186.0,0.0978723,"IU/mL. HBsAg reduction had a positive correlation (r = 0.309; P = 0.0017) with HBV DNA reduction, and was predictive of HBV DNA reduction ≥","[{'ForeName': 'Huai-Lung', 'Initials': 'HL', 'LastName': 'Chang', 'Affiliation': 'School of Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Wan-Hsin', 'Initials': 'WH', 'LastName': 'Wen', 'Affiliation': 'Department of Pediatrics, Cardinal Tien Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Chien-Nan', 'Initials': 'CN', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yu-En', 'Initials': 'YE', 'LastName': 'Chiu', 'Affiliation': 'Department of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Liu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Mei-Hwei', 'Initials': 'MH', 'LastName': 'Chang', 'Affiliation': 'Department of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Lung-Huang', 'Initials': 'LH', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatrics, Cathay General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Huey-Ling', 'Initials': 'HL', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}]",Journal of viral hepatitis,['10.1111/jvh.13628']
2096,34666302,"Pentoxifylline effects on hospitalized patients with COVID19: A randomized, double-blind clinical trial.","Pentoxifylline (PTX) has broad-spectrum properties such as anti-inflammatory, anticoagulant, and antiviral effects. The aim of this study was to evaluate the efficacy and safety of PTX in hospitalized patients with COVID-19. This double-blind, placebo-controlled randomized clinical trial was conducted on hospitalized patients with COVID-19. The recruited patients were randomly (1:1) assigned to the PTX group and the placebo group. The intervention group received PTX capsules at a dose of 400 mg three times a day for 10 days along with the national regimen, including interferon plus lopinavir/ritonavir and hydroxychloroquine. The primary outcome was the improvement of clinical scores. The secondary outcomes, on the other hand, were improvement in inflammatory and oxidative stress factors and hospital complications. From a total of 102 patients who met the inclusion criteria, 72 individuals completed the study and were analyzed. No significant differences were shown in demographics and baseline clinical characteristics. Clinical scores was not significant between the two groups (P = 0.31 and 0.07 for day 5 and 11, respectively). Although the mean serum levels of interleukin-6 (IL-6) and glutathione changed significantly after 5 days in the PTX group (P = 0.03 and p = 0.04), ICU admission, intubation, and hospital stay did not differ between the two groups. The results of our study did not show any superiority of PTX over placebo in improving the clinical outcomes of patients with COVID-19. Although PTX had a beneficial effect on IL-6 and showed an acceptable safety profile, it did not offer any clinical benefit for COVID-19 complications.",2021,"Clinical scores was not significant between the two groups (P = 0.31 and 0.07 for day 5 and 11, respectively).","['102 patients who met the inclusion criteria, 72 individuals completed the study and were analyzed', 'hospitalized patients with COVID19', 'hospitalized patients with COVID-19', 'patients with COVID-19']","['interferon plus lopinavir/ritonavir and hydroxychloroquine', 'Pentoxifylline (PTX', 'PTX capsules', 'Pentoxifylline', 'placebo', 'PTX']","['Clinical scores', 'ICU admission, intubation, and hospital stay', 'inflammatory and oxidative stress factors and hospital complications', 'improvement of clinical scores', 'efficacy and safety', 'mean serum levels of interleukin-6 (IL-6) and glutathione']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}]",102.0,0.623993,"Clinical scores was not significant between the two groups (P = 0.31 and 0.07 for day 5 and 11, respectively).","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Azizi', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Rouhani', 'Affiliation': 'Department of Infectious Disease, Ibne Sina Medical and Educational Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Shaki', 'Affiliation': 'Pharmaceutical Research Center, Department of toxicology and pharmacology, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Karimpour-Razkenari', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Monireh', 'Initials': 'M', 'LastName': 'Ghazaeian', 'Affiliation': 'Pharmaceutical Research Center, Department of toxicology and pharmacology, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: ghazaeianm@gmail.com.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Pharmaceutical Research Center, Department of toxicology and pharmacology, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Pharmaceutical Research Center, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Fallah', 'Affiliation': 'Department of Biostatistics, Ibne Sina Medical and Educational Center, Mazandaran University of Medical Sciences, Sari, Iran.'}]",International immunopharmacology,['10.1016/j.intimp.2021.108227']
2097,34717169,Examining predictive factors of nursing students' self-confidence in multiple simulation sessions: A randomized controlled study.,"AIM


The aim of this study was to examine and describe predictors of self-confidence among nursing students attending multiple simulation-based education sessions during a bachelor program.
DESIGN


This was a randomized controlled longitudinal study.
METHODS


Participants (n = 146) were randomly assigned to a single or double set of acute care scenarios in each session. Participants attended 4 days of simulation sessions throughout a 3-year bachelor program. At four separate time points, both groups answered a survey including the Self-confidence scale and The Kolb Learning Style Inventory version 3.1. Descriptive statistics, cross-tabulations and linear models were employed to analyze the data.
RESULTS


No significant interaction effects were found between the students' self-confidence at the end of the educational program and predictive factors favoring a double set of simulation scenarios. Most third-year students (n = 52, 85%) preferred a concrete learning mode at baseline.
CONCLUSIONS


No significant predictive factors increasing self-confidence in favor of a double set of simulation scenarios could be demonstrated in this study. Hence, the continuous search for how to effectively implement SBE is of major importance for the development of SBE as a pedagogical method and remains a challenge.",2021,No significant predictive factors increasing self-confidence in favor of a double set of simulation scenarios could be demonstrated in this study.,"['Participants (n\xa0', 'nursing students attending multiple simulation-based education sessions during a bachelor program', ""nursing students' self-confidence in multiple simulation sessions"", '146']",[],['Self-confidence scale and The Kolb Learning Style Inventory version 3.1'],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517683', 'cui_str': '3.1'}]",146.0,0.141952,No significant predictive factors increasing self-confidence in favor of a double set of simulation scenarios could be demonstrated in this study.,"[{'ForeName': 'Alette H', 'Initials': 'AH', 'LastName': 'Svellingen', 'Affiliation': 'Centre of Diaconia and Professional Practice, VID Specialized University, Oslo, Norway; Faculty of Health Studies, VID Specialized University, Bergen, Norway. Electronic address: Alette.Svellingen@vid.no.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Røykenes', 'Affiliation': 'Faculty of Health Studies, VID Specialized University, Bergen, Norway. Electronic address: Kari.Roykenes@vid.no.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Forstrønen', 'Affiliation': 'Faculty of Health Studies, VID Specialized University, Bergen, Norway. Electronic address: Astrid.Forstronen@vid.no.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Assmus', 'Affiliation': 'Biostatistician, Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway. Electronic address: Jorg.Assmus@helse-bergen.no.'}, {'ForeName': 'Guttorm', 'Initials': 'G', 'LastName': 'Brattebø', 'Affiliation': 'Department of Anaesthesia & Intensive Care, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway. Electronic address: Guttorm.Brattebo@helse-bergen.no.'}]",Nurse education in practice,['10.1016/j.nepr.2021.103231']
2098,34719269,Functional outcome of routine versus on-demand removal of the syndesmotic screw: a multicentre randomized controlled trial.,"AIMS


The aim of this study was to investigate whether on-demand removal (ODR) is noninferior to routine removal (RR) of syndesmotic screws regarding functional outcome.
METHODS


Adult patients (aged above 17 years) with traumatic syndesmotic injury, surgically treated within 14 days of trauma using one or two syndesmotic screws, were eligible (n = 490) for inclusion in this randomized controlled noninferiority trial. A total of 197 patients were randomized for either ODR (retaining the syndesmotic screw unless there were complaints warranting removal) or RR (screw removed at eight to 12 weeks after syndesmotic fixation), of whom 152 completed the study. The primary outcome was functional outcome at 12 months after screw placement, measured by the Olerud-Molander Ankle Score (OMAS).
RESULTS


There were 152 patients included in final analysis (RR = 73; ODR = 79). Of these, 59.2% were male (n = 90), and the mean age was 46.9 years (SD 14.6). Median OMAS at 12 months after syndesmotic fixation was 85 (interquartile range (IQR) 60 to 95) for RR and 80 (IQR 65 to 100) for ODR. The noninferiority test indicated that the observed effect size was significantly within the equivalent bounds of -10 and 10 scale points (p < 0.001) for both the intention-to-treat and per-protocol, meaning that ODR was not inferior to RR. There were significantly more complications in the RR group (12/73) than in the ODR group (1/79) (p = 0.007).
CONCLUSION


ODR of the syndesmotic screw is not inferior to routine removal when it comes to functional outcome. Combined with the high complication rate of screw removal, this offers a strong argument to adopt on demand removal as standard practice of care after syndesmotic screw fixation. Cite this article:  Bone Joint J  2021;103-B(11):1709-1716.",2021,"There were significantly more complications in the RR group (12/73) than in the ODR group (1/79) (p = 0.007).
","['197 patients were randomized for either ODR (retaining the syndesmotic screw unless there were complaints warranting removal) or RR (screw removed at eight to 12 weeks after syndesmotic fixation), of whom 152 completed the study', '59.2% were male (n = 90), and the mean age was 46.9 years (SD 14.6', 'Adult patients (aged above 17 years) with traumatic syndesmotic injury, surgically treated within 14 days of trauma using one or two syndesmotic screws, were eligible (n = 490']","['routine versus on-demand removal of the syndesmotic screw', 'demand removal (ODR']","['complications', 'Median OMAS', 'functional outcome at 12 months after screw placement, measured by the Olerud-Molander Ankle Score (OMAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C3661498', 'cui_str': 'Syndesmotic Injuries'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",197.0,0.449732,"There were significantly more complications in the RR group (12/73) than in the ODR group (1/79) (p = 0.007).
","[{'ForeName': 'Fay R K', 'Initials': 'FRK', 'LastName': 'Sanders', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Merel F', 'Initials': 'MF', 'LastName': 'Birnie', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Siem A', 'Initials': 'SA', 'LastName': 'Dingemans', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Michel P J', 'Initials': 'MPJ', 'LastName': 'van den Bekerom', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Parkkinen', 'Affiliation': 'Department of Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ruben N', 'Initials': 'RN', 'LastName': 'van Veen', 'Affiliation': 'Department of Trauma Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Department of Trauma Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schepers', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}]",The bone & joint journal,['10.1302/0301-620X.103B11.BJJ-2021-0348.R2']
2099,34666281,Altered immediate behavioral response to partial social exclusion: A cross-diagnostic study in patients with borderline personality disorder and persistent depressive disorder.,"Borderline personality disorder (BPD) and persistent depressive disorder (PDD) are related to interpersonal dysfunction which might become particularly apparent in situations of social exclusion (SE). While emotional responses to SE have been widely explored, behavioral data in clinical samples are lacking. In this cross-diagnostic study, we applied a variant of the Cyberball paradigm to investigate the dynamic behavioral response to partial SE in BPD and PDD. BPD patients (n = 36), PDD patients (n = 34) and age and gender matched healthy controls (HC) (total n = 70) played experimental (i.e. partial SE Cyberball) and control (i.e. inclusion only) conditions in randomized order. While all groups tended to increase ball tosses towards the excluder in response to SE, this behavioral turn was significantly lower in PDD (p = .03, d = -.30) and trendwise in BPD patients (p = .06, d = -.28). Thus, an altered immediate response to partial SE was observed in BPD and PDD, in addition to the emotional reactions. This study supports the hypothesis of a behavioral coping with SE in BPD and PDD that might be problematic in the long run and provides an experimental paradigm for future research on interpersonal dysfunction.",2021,"While all groups tended to increase ball tosses towards the excluder in response to SE, this behavioral turn was significantly lower in PDD (p = ","['BPD patients (n\xa0=\xa036), PDD patients (n\xa0=\xa034) and age and gender matched healthy controls (HC) (total n\xa0=\xa070) played experimental (i.e. partial SE Cyberball) and control (i.e. inclusion only) conditions in randomized order', 'patients with borderline personality disorder and persistent depressive disorder', 'Borderline personality disorder (BPD) and persistent depressive disorder (PDD']",['partial social exclusion'],[],"[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0237827', 'cui_str': 'Social exclusion'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0237827', 'cui_str': 'Social exclusion'}]",[],70.0,0.0254686,"While all groups tended to increase ball tosses towards the excluder in response to SE, this behavioral turn was significantly lower in PDD (p = ","[{'ForeName': 'Barbara B', 'Initials': 'BB', 'LastName': 'Barton', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Germany, Nussbaumstraße 7, 80336, Munich, Germany. Electronic address: Barbara.Barton@med.uni-muenchen.de.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Germany, Nussbaumstraße 7, 80336, Munich, Germany; Hochschule Fresenius, University of Applied Sciences, Munich, Germany, Charles-de-Gaulle-Straße 2, 81737, Munich, Germany; Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University Munich, Germany, Leopoldstraße 13, 80802, Munich, Germany. Electronic address: Stephan.Georigk@med.uni-muenchen.de.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Wüstenberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Charité - Universitätsmedizin Berlin, Germany, Bonhoefferweg 3, 10117, Berlin, Germany; Department of Clinical Psychology and Psychotherapy, Ruprecht Karl University of Hauptstraße 47-51, 69117, Heidelberg, Germany. Electronic address: Torsten.Wuestenberg@mailbox.org.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dewald-Kaufmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Germany, Nussbaumstraße 7, 80336, Munich, Germany; Hochschule Fresenius, University of Applied Sciences, Munich, Germany, Charles-de-Gaulle-Straße 2, 81737, Munich, Germany. Electronic address: Julia.Dewald_Kaufmann@med.uni-muenchen.de.'}, {'ForeName': 'Matthias A', 'Initials': 'MA', 'LastName': 'Reinhard', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Germany, Nussbaumstraße 7, 80336, Munich, Germany. Electronic address: Matthias.Reinhard@med.uni-muenchen.de.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Musil', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Germany, Nussbaumstraße 7, 80336, Munich, Germany. Electronic address: Richard.Musil@med.uni-muenchen.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ehring', 'Affiliation': 'Department of Psychology, LMU Munich, Munich, Germany, Leopoldstraße 13, 80802, Munich, Germany. Electronic address: Thomas.Ehring@psy.lmu.de.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jobst', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Germany, Nussbaumstraße 7, 80336, Munich, Germany. Electronic address: Andrea.Jobst@med.uni-muenchen.de.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Germany, Nussbaumstraße 7, 80336, Munich, Germany. Electronic address: Frank.Padberg@med.uni-muenchen.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.10.005']
2100,34666273,Early subthalamic nucleus deep brain stimulation in Parkinson's disease reduces long-term medication costs.,"INTRODUCTION


Subthalamic nucleus (STN) deep brain stimulation (DBS) is recognized as a safe and effective treatment in mid- and advanced-staged Parkinson's disease (PD) that decreases the need for PD medications and their associated costs. This study reports medication costs from the only clinical trial to evaluate DBS in patients with early-stage PD and projects costs through advanced-stage disease.
METHODS


The DBS in early-stage PD pilot was a prospective, single-blind clinical trial that randomized 30 patients with early-stage PD 1:1 to receive bilateral STN-DBS plus optimal drug therapy (ODT) or ODT alone. Subjects who completed the trial participated in an observational follow-up study and were evaluated annually for five years after randomization. PD medication data collected at each study visit were used to calculate and project medication costs (n = 28).
RESULTS


Five-year cumulative medication cost reduction with early DBS+ODT was $28,246. Mean annual medication cost for early DBS+ODT subjects was 2.4 times lower than early ODT subjects (β = 2.4, 95%CI:1.5-3.7, p = 0.0004). Early DBS+ODT is projected to reduce cumulative medication costs by $104,958 over 15 years of disease duration.
CONCLUSION


DBS in early-stage PD may provide long-term medication cost reduction compared to standard care.",2021,"Early DBS+ODT is projected to reduce cumulative medication costs by $104,958 over 15 years of disease duration.
","['30 patients with early-stage PD 1:1 to receive', 'patients with early-stage PD and projects costs through advanced-stage disease', 'Subjects who completed the trial participated in an observational follow-up study and were evaluated annually for five years after randomization']","['DBS', 'bilateral STN-DBS plus optimal drug therapy (ODT) or ODT alone', 'Subthalamic nucleus (STN) deep brain stimulation (DBS']","['Mean annual medication cost', 'cumulative medication costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",30.0,0.101694,"Early DBS+ODT is projected to reduce cumulative medication costs by $104,958 over 15 years of disease duration.
","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Hacker', 'Affiliation': ""Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States; Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, 2201 Children's Way Suite 1221, Nashville, TN 37212. Electronic address: mallory.hacker@vumc.org.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Cannard', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: grace.cannard@gmail.com.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Turchan', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: turchanm@gmail.com.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Meystedt', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: jacqueline.c.meystedt@vanderbilt.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Davis', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: thomas.l.davis@vumc.org.'}, {'ForeName': 'Fenna', 'Initials': 'F', 'LastName': 'Phibbs', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: fenna.phibbs@vumc.org.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States; Department of Neurology, University of Louisville, Academic Offices, 500 South Preston St., HSC-A Bldg. Suite 113, Louisville, KY 40202, United States. Electronic address: peter.hedera@louisville.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Konrad', 'Affiliation': 'Department of Neurosurgery, Vanderbilt University Medical Center, 1161 21st Ave. So., T4224 Medical Center North, Nashville, TN 37232-2380, United States; Department of Neurosurgery, West Virginia University, Room 4300 HSS, Morgantown, WV 26506, United States. Electronic address: peter.konrad@hsc.wvu.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Charles', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: david.charles@vumc.org.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2021.106976']
2101,34695711,How acute physical and psychological stress differentially influence the kynurenine pathway: A randomized cross-over trial.,"Psychological stress is associated with the pathogenesis of several neuropsychiatric disorders. In contrast, physical stress, as provoked by exercise, counteracts symptoms and potentially also disease progression. The kynurenine pathway, which is imbalanced in neuropsychiatric disorders, responds to both psychological and physical stress. Here, we compared the acute effects of psychological versus physical stress on the kynurenine pathway and inflammatory mediators. Thirty-five healthy males (mean age: 24.09±3.39 years) underwent both the Trier Social Stress Test (psychological stressor) and the Wingate-Test (physical stressor). The kinetics of tryptophan and its metabolites as well as cytokines IL-6, IFN-γ, TNF-α, and IL-10 were measured before and after the two stress conditions. After both stressors, there was a significant change over time for the kinetics of tryptophan metabolites and for cytokines. Furthermore, the reactivity of kynurenine pathway metabolite ratios and cytokines was statistically greater after physical stress than after psychological stress. The increased metabolic flux towards kynurenic acid following acute physical stress suggests an exercise-induced neuroprotective mechanism. Despite the paradoxical influence of both stressors on neuropsychiatric diseases, the acute kynurenine pathway reactivity appears to be similar, although effects were more pronounced in response to physical stress.",2021,"The kinetics of tryptophan and its metabolites as well as cytokines IL-6, IFN-γ, TNF-α, and IL-10 were measured before and after the two stress conditions.",['Thirty-five healthy males (mean age: 24.09±3.39 years'],['Trier Social Stress Test (psychological stressor) and the Wingate-Test (physical stressor'],"['kinetics of tryptophan and its metabolites as well as cytokines IL-6, IFN-γ, TNF-α, and IL-10', 'reactivity of kynurenine pathway metabolite ratios and cytokines']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0022818', 'cui_str': 'Kynurenine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",35.0,0.0208667,"The kinetics of tryptophan and its metabolites as well as cytokines IL-6, IFN-γ, TNF-α, and IL-10 were measured before and after the two stress conditions.","[{'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Herhaus', 'Affiliation': 'Medical Psychology and Medical Sociology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Joisten', 'Affiliation': 'Division of Performance and Health (Sports Medicine), Department for Sport and Sport Science, TU Dortmund University, Dortmund, Germany. Electronic address: niklas.joisten@tu-dortmund.de.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Wessels', 'Affiliation': 'Institute of Immunology, Medical Faculty, RWTH Aachen University, Aachen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Division of Performance and Health (Sports Medicine), Department for Sport and Sport Science, TU Dortmund University, Dortmund, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Petrowski', 'Affiliation': 'Medical Psychology and Medical Sociology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105433']
2102,34678585,Does branched-chain amino acid supplementation improve pulmonary rehabilitation effect in COPD?,"BACKGROUND


Muscle wasting is frequent in chronic obstructive lung disease (COPD) and associated with low branched-chain amino acids (BCAA). We hypothesized that BCAA supplementation could potentiate the effect of a pulmonary rehabilitation program (PRP) by inducing muscular change.
MATERIALS AND METHODS


Sixty COPD patients (GOLD 2-3) were involved in an ambulatory 4-week PRP either with BCAA oral daily supplementation or placebo daily supplementation in a randomized double-blind design. Maximal exercise test including quadriceps oxygenation measurements, functional exercise test, muscle strength, lung function tests, body composition, dyspnea and quality of life were assessed before and after PRP.
RESULTS


Fifty-four patients (64.9 ± 8.3 years) completed the protocol. In both groups, maximal exercise capacity, functional and muscle performances, quality of life and dyspnea were improved after 4-week PRP (p ≤ 0.01). Changes in muscle oxygenation during the maximal exercise and recovery period were not modified after 4-week PRP in BCAA group. Contrarily, in the placebo group the muscle oxygenation kinetic of recovery was slowed down after PRP.
CONCLUSION


This study demonstrated that a 4-week PRP with BCAA supplementation is not more beneficial than PRP alone for patients. A longer duration of supplementation or a more precise targeting of patients would need to be investigated to validate an effect on muscle recovery and to demonstrate other beneficial effects.",2021,Changes in muscle oxygenation during the maximal exercise and recovery period were not modified after 4-week PRP in BCAA group.,"['Fifty-four patients (64.9\xa0±\xa08.3 years) completed the protocol', 'Sixty COPD patients (GOLD 2-3', 'chronic obstructive lung disease (COPD']","['placebo', 'branched-chain amino acid supplementation', 'PRP with BCAA supplementation', 'BCAA oral daily supplementation or placebo daily supplementation', 'BCAA supplementation']","['quadriceps oxygenation measurements, functional exercise test, muscle strength, lung function tests, body composition, dyspnea and quality of life', 'maximal exercise capacity, functional and muscle performances, quality of life and dyspnea', 'muscle oxygenation kinetic of recovery']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018026', 'cui_str': 'Gold'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556085', 'cui_str': 'Branched chain amino acid supplementation'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",60.0,0.316916,Changes in muscle oxygenation during the maximal exercise and recovery period were not modified after 4-week PRP in BCAA group.,"[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'de Bisschop', 'Affiliation': 'Université de Poitiers, MOVE, F-86000, Poitiers, France. Electronic address: claire.de.bisschop@univ-poitiers.fr.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Caron', 'Affiliation': ""CHU Poitiers, F-86000, Poitiers, France; Centre de Réadaptation Du Moulin Vert, F-86340, Nieuil L'espoir, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Ingrand', 'Affiliation': 'Université de Poitiers, CHU Poitiers, INSERM CIC 1402, F-86000, Poitiers, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Bretonneau', 'Affiliation': 'Université de Poitiers, MOVE, F-86000, Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dupuy', 'Affiliation': 'Université de Poitiers, MOVE, F-86000, Poitiers, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Meurice', 'Affiliation': 'Université de Poitiers, CHU Poitiers, F-86000, Poitiers, France.'}]",Respiratory medicine,['10.1016/j.rmed.2021.106642']
2103,34700258,Attentional control may be modifiable with Mindfulness-Based Cognitive Therapy to Prevent Suicide.,"OBJECTIVE


To test whether Mindfulness-Based Cognitive Therapy to Prevent Suicide (MBCT-S) is associated with improvement in attentional control, an objective marker of suicide attempt.
METHOD


In the context of a randomized clinical trial targeting suicide risk in Veterans, computerized Stroop and emotion Stroop (E-Stroop) tasks were administered 3 times over 6-months follow-up to 135 high suicide risk Veterans. Seventy were randomized to receive MBCT-S in addition to enhanced treatment as usual (eTAU), and 65 were randomized to eTAU only. E-Stroop word types included positively- and negatively-valenced emotion, suicide, and combat-related words. Interference scores and mixed effects linear regression analyses were used.
RESULTS


Veterans receiving MBCT-S showed a more favorable trajectory of attentional control over time, as indicated by performance on two E-Stroop tasks. Combat-stress interference scores improved over time among Veterans in MBCT-S. Interference processing time for negative affective words deteriorated over time among Veterans receiving eTAU only.
CONCLUSIONS


MBCT-S may effectively target attentional control, and in particular reduce processing time during affective interference, in high suicide risk Veterans. Future studies to replicate these findings are warranted.",2021,"Combat-stress interference scores improved over time among Veterans in MBCT-S. Interference processing time for negative affective words deteriorated over time among Veterans receiving eTAU only.
",['135 high suicide risk Veterans'],"['MBCT-S in addition to enhanced treatment as usual (eTAU', 'Mindfulness-Based Cognitive Therapy', 'computerized Stroop and emotion Stroop (E-Stroop) tasks']","['Combat-stress interference scores', 'favorable trajectory of attentional control']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C1271074', 'cui_str': 'High suicide risk'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",135.0,0.0448798,"Combat-stress interference scores improved over time among Veterans in MBCT-S. Interference processing time for negative affective words deteriorated over time among Veterans receiving eTAU only.
","[{'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Chesin', 'Affiliation': 'Department of Psychology, William Paterson University, USA. Electronic address: chesinm@wpunj.edu.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Keilp', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and New York State Psychiatric Institute, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kline', 'Affiliation': 'Department of Psychiatry, Robert Wood Johnson Medical School, Rutgers, The State University of New Jersey, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and New York State Psychiatric Institute, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Myers', 'Affiliation': 'Veterans Affairs New Jersey Healthcare System, USA; Department of Pharmacology, Physiology, and Neuroscience, New Jersey Medical School, Rutgers, The State University of New Jersey, USA.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Latorre', 'Affiliation': 'Veterans Affairs New Jersey Healthcare System, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'St Hill', 'Affiliation': 'Veterans Affairs New Jersey Healthcare System, USA.'}, {'ForeName': 'Rachael B', 'Initials': 'RB', 'LastName': 'Miller', 'Affiliation': 'Veterans Affairs New Jersey Healthcare System, USA.'}, {'ForeName': 'Arlene R', 'Initials': 'AR', 'LastName': 'King', 'Affiliation': 'Veterans Affairs New Jersey Healthcare System, USA.'}, {'ForeName': 'Dianna R', 'Initials': 'DR', 'LastName': 'Boschulte', 'Affiliation': 'Veterans Affairs New Jersey Healthcare System, USA.'}, {'ForeName': 'Kailyn M', 'Initials': 'KM', 'LastName': 'Rodriguez', 'Affiliation': 'Veterans Affairs New Jersey Healthcare System, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Callahan', 'Affiliation': 'Veterans Affairs New Jersey Healthcare System, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Sedita', 'Affiliation': 'Department of Psychology, William Paterson University, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Interian', 'Affiliation': 'Veterans Affairs New Jersey Healthcare System, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103988']
2104,34700272,Influence of nimodipine combined with ulinastatin on neurological function and inflammatory reaction in patients with cerebral vasospasm after subarachnoid hemorrhage.,"OBJECTIVE


This study aimed to discuss the influence of nimodipine+ulinastatin on the neurological function and inflammatory reaction in patients with cerebral vasospasm (CVS) after subarachnoid hemorrhage (SAH).
METHODS


Overall, 90 patients with CVS after SAH who were admitted to our hospital were enrolled in this study and randomly divided into research and control groups (n = 45 for both groups). On the basis of conventional therapy, patients in the control group were injected with ulinastatin and those in the research group were injected with ulinastatin+nimodipine through an intravenous drip for 7 days with the others the same as those of the control group.
RESULTS


Blood flow velocity in all cerebral arteries was lower in the research group than in the control group after treatment (P < 0.05). Calcitonin gene-related peptide and nitric oxide levels were higher in the research group than in the control group after treatment (P < 0.05). Endothelin levels were lower in the research group than in the control group (P < 0.05). The total effective rate was higher in the research group than in the control group (P < 0.05). Glasgow Coma Scale scores were higher in the research group than in the control group (P < 0.05).
CONCLUSION


The drug combination of nimodipine and ulinastatin improved blood flow and neurological function in patients with CVS after SAH and enhanced the therapeutic efficacy; the underlying mechanism may be associated with the regulation of vascular endothelial dilatation function and the inhibition of relevant inflammatory factors' expression.",2021,Calcitonin gene-related peptide and nitric oxide levels were higher in the research group than in the control group after treatment (P < 0.05).,"['patients with cerebral vasospasm after subarachnoid hemorrhage', '90 patients with CVS after SAH who were admitted to our hospital', 'patients with cerebral vasospasm (CVS) after subarachnoid hemorrhage (SAH', 'patients with CVS after SAH']","['nimodipine and ulinastatin', 'nimodipine+ulinastatin', 'ulinastatin+nimodipine', 'ulinastatin', 'nimodipine combined with ulinastatin']","['total effective rate', 'Calcitonin gene-related peptide and nitric oxide levels', 'Endothelin levels', 'neurological function and inflammatory reaction', 'blood flow and neurological function', 'Blood flow velocity', 'Glasgow Coma Scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0265110', 'cui_str': 'Spasm of cerebral arteries'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0077906', 'cui_str': 'urinastatin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079284', 'cui_str': 'Endothelin'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.0280608,Calcitonin gene-related peptide and nitric oxide levels were higher in the research group than in the control group after treatment (P < 0.05).,"[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, the Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an, Jiangsu, China. Electronic address: chenming801123@sina.cn.""}, {'ForeName': 'Qingxiu', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, the Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China. Electronic address: qingxiuzhang@126.com.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, the Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China. Electronic address: lhy4531@yeah.net.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': ""Department of Neurology, the Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an, Jiangsu, China. Electronic address: zww051710@163.com.""}, {'ForeName': 'Xiue', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, the Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China. Electronic address: wxeqq@163.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2021.106981']
2105,34705785,Randomized Clinical Trial of the Accuracy of Patient-Specific Implants versus CAD/CAM Splints in Orthognathic Surgery.,"BACKGROUND


The maxilla position is essential for the aesthetic and functional outcomes of orthognathic surgery. Previous studies demonstrated the advantages of patient-specific implants in orthognathic surgery. However, more data are needed to confirm the superiority of patient-specific implants over surgical splints created with computer-aided design/computer-aided manufacturing (CAD/CAM). This randomized controlled trial aimed to compare the accuracy of patient-specific implants and CAD/CAM splints for maxilla repositioning in orthognathic surgery.
METHODS


Patients (n = 64) who required orthognathic surgery were randomly assigned to use either patient-specific implants (patient-specific implant group) or CAD/CAM surgical splints (splint group) to reposition the maxilla. The outcome evaluation was completed by comparing virtual plans with actual results. The primary outcome was the discrepancies of the centroid position of the maxilla. Other translation and orientation discrepancies of the maxilla were also assessed.
RESULTS


The authors analyzed 27 patients in the patient-specific implant group and 31 in the splint group. The maxilla position discrepancy was 1.41 ± 0.58 mm in the patient-specific implant group and 2.20 ± 0.94 mm in the splint group; the between-group difference was significant (p < 0.001). For the patient-specific implant group, the largest translation discrepancy was 1.02 ± 0.66 mm in the anteroposterior direction, and the largest orientation discrepancy was 1.85 ± 1.42 degrees in pitch. For the splint group, the largest translation discrepancy was 1.23 ± 0.93 mm in the mediolateral direction, and the largest orientation discrepancy was 1.72 ± 1.56 degrees in pitch.
CONCLUSION


The result showed that using patient-specific implants in orthognathic surgery resulted in a more accurate maxilla position than CAD/CAM surgical splints.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, I.",2021,"The result showed that using patient-specific implants in orthognathic surgery resulted in a more accurate maxilla position than CAD/CAM surgical splints.
","['27 patients in the patient-specific implant group and 31 in the splint group', 'Patients (n = 64) who required orthognathic surgery', 'Orthognathic Surgery']","['CAD/CAM splints', 'patient-specific implants (patient-specific implant group) or CAD/CAM surgical splints (splint group) to reposition the maxilla', 'Patient-Specific Implants versus CAD/CAM Splints']","['maxilla position discrepancy', 'discrepancies of the centroid position of the maxilla', 'accurate maxilla position']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]","[{'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C0162516', 'cui_str': 'Computer-Assisted Manufacturing'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",64.0,0.144497,"The result showed that using patient-specific implants in orthognathic surgery resulted in a more accurate maxilla position than CAD/CAM surgical splints.
","[{'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""From the Departments of Oral and Craniomaxillofacial Surgery, Shanghai 9th People's Hospital, Shanghai Jiao Tong University College of Medicine; and Shanghai Key Laboratory of Stomatology.""}, {'ForeName': 'Hongpu', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ""From the Departments of Oral and Craniomaxillofacial Surgery, Shanghai 9th People's Hospital, Shanghai Jiao Tong University College of Medicine; and Shanghai Key Laboratory of Stomatology.""}, {'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': ""From the Departments of Oral and Craniomaxillofacial Surgery, Shanghai 9th People's Hospital, Shanghai Jiao Tong University College of Medicine; and Shanghai Key Laboratory of Stomatology.""}, {'ForeName': 'Yifeng', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': ""From the Departments of Oral and Craniomaxillofacial Surgery, Shanghai 9th People's Hospital, Shanghai Jiao Tong University College of Medicine; and Shanghai Key Laboratory of Stomatology.""}, {'ForeName': 'Tianjia', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Oral and Craniomaxillofacial Surgery, Shanghai 9th People's Hospital, Shanghai Jiao Tong University College of Medicine; and Shanghai Key Laboratory of Stomatology.""}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""From the Departments of Oral and Craniomaxillofacial Surgery, Shanghai 9th People's Hospital, Shanghai Jiao Tong University College of Medicine; and Shanghai Key Laboratory of Stomatology.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Oral and Craniomaxillofacial Surgery, Shanghai 9th People's Hospital, Shanghai Jiao Tong University College of Medicine; and Shanghai Key Laboratory of Stomatology.""}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Oral and Craniomaxillofacial Surgery, Shanghai 9th People's Hospital, Shanghai Jiao Tong University College of Medicine; and Shanghai Key Laboratory of Stomatology.""}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000008427']
2106,34715471,Zonisamide improves wearing off in Parkinson's disease without exacerbating dyskinesia: Post hoc analysis of phase 2 and phase 3 clinical trials.,"INTRODUCTION


Although phase 2 and 3 clinical trials in Japan showed that zonisamide improved wearing off in patients with Parkinson's disease (PD), no studies to date have evaluated whether zonisamide improves wearing off in patients with PD without exacerbating dyskinesia. Therefore, we examined this hypothesis in a post hoc analysis of pooled data from the previous phase 2 and 3 trials.
METHODS


Both trials evaluated zonisamide 25 mg and 50 mg versus placebo during a 12-week treatment period. In our analysis, primary efficacy variables were adjusted mean change in wearing off (evaluated as change in ""off"" time) and dyskinesia from baseline to 12 weeks. Dyskinesia was evaluated using Unified Parkinson's Disease Rating Scale (UPDRS) part 4 items 32 (4-32; duration of dyskinesia) and 33 (4-33; disability of dyskinesia) score. Criteria outcomes included rates of patients meeting specific criteria based on off time plus UPDRS part 4-32 or 4-33.
RESULTS


A total of 212 patients were included in this analysis. Zonisamide 50 mg significantly reduced off time and UPDRS part 4-33 score at week 12 versus placebo without increasing UPDRS part 4-32 score. The proportion of patients receiving zonisamide 50 mg who met the criterion ""Off time decreased and UPDRS part 4-33 score did not increase"" was significantly higher than that of patients receiving placebo.
CONCLUSION


Zonisamide improves wearing off without exacerbating dyskinesia in Japanese patients with PD. Moreover, zonisamide 50 mg may improve dyskinesia. Further studies are needed to prospectively determine the benefits and clinical relevance of zonisamide on dyskinesia.",2021,Zonisamide 50 mg significantly reduced off time and UPDRS part 4-33 score at week 12 versus placebo without increasing UPDRS part 4-32 score.,"['A total of 212 patients were included in this analysis', 'Japanese patients with PD', 'patients with PD without exacerbating dyskinesia', ""Parkinson's disease without exacerbating dyskinesia"", ""patients with Parkinson's disease (PD""]","['zonisamide', 'zonisamide 25\xa0mg and 50\xa0mg versus placebo', 'placebo', 'Zonisamide']","['Dyskinesia', 'wearing off without exacerbating dyskinesia', 'rates of patients meeting specific criteria based on off time plus UPDRS', 'off"" time) and dyskinesia', ""Unified Parkinson's Disease Rating Scale (UPDRS"", 'criterion ""Off time decreased and UPDRS part 4-33 score did not increase', 'dyskinesia', 'disability of dyskinesia) score', 'time and UPDRS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]","[{'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C1331568', 'cui_str': 'zonisamide 25 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",212.0,0.128194,Zonisamide 50 mg significantly reduced off time and UPDRS part 4-33 score at week 12 versus placebo without increasing UPDRS part 4-32 score.,"[{'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan. Electronic address: tsuboi@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Data Science, Sumitomo Dainippon Pharma Co., Ltd., 1-13-1, Kyobashi, Chuo-ku, Tokyo 104-8356, Japan. Electronic address: masatoshi-nakamura@ds-pharma.co.jp.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Medical Affairs, Sumitomo Dainippon Pharma Co., Ltd., 1-13-1, Kyobashi, Chuo-ku, Tokyo 104-8356, Japan. Electronic address: hidenori-maruyama@ds-pharma.co.jp.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Matsumoto', 'Affiliation': 'Medical Affairs, Sumitomo Dainippon Pharma Co., Ltd., 1-13-1, Kyobashi, Chuo-ku, Tokyo 104-8356, Japan. Electronic address: yuji-matsumoto@ds-pharma.co.jp.'}]",Journal of the neurological sciences,['10.1016/j.jns.2021.120026']
2107,34715563,"Bachelor of nursing students' attitudes toward teamwork in healthcare: The impact of implementing a teamSTEPPS® team training program - A longitudinal, quasi-experimental study.","BACKGROUND


Teamwork skills are essential to the quality of care and patient safety; nevertheless, team training is limited in Bachelor of Nursing degree programs in Norway.
OBJECTIVES


The objective of this study was to explore the impact of implementing a TeamSTEPPS® team training intervention on Bachelor of Nursing students' attitudes toward teamwork in health care.
DESIGN


A longitudinal quasi-experimental design with pre- and posttests was used.
SETTINGS


One intervention group and one control group were recruited from two campuses at a Norwegian university offering a Bachelor of Nursing degree.
PARTICIPANTS


Subjects were recruited from a population of 423 students.
METHODS


For 26 months, the intervention group was exposed to the TeamSTEPPS® team training program with various learning activities to enhance teamwork skills. The intervention group and the control group responded to the Norwegian version of the TeamSTEPPS® Teamwork Attitude Questionnaire (T-TAQ) before the intervention (T0), after ten months (T1), and after 24 months (T2). The students participated in survey T0 and T1 was defined as Sample 1 and students participated in survey T0 and T2 was defined as Sample 2 The data were analyzed with parametric and nonparametric statistics.
RESULTS


At T0 there was a significant difference between the intervention and control group. The intervention group showed a significant positive change in the Total T-TAQ score from T0 to T1 and from T0 to T2. The change in mean score differed significantly between the intervention and control group in favor of the intervention group.
CONCLUSIONS


This study showed that a team training program improved Bachelor of Nursing students' attitudes toward teamwork. Therefore, we recommend that the TeamSTEPPS® team training program be implemented in Bachelor of Nursing programs to facilitate a culture of teamwork.",2021,"The intervention group and the control group responded to the Norwegian version of the TeamSTEPPS® Teamwork Attitude Questionnaire (T-TAQ) before the intervention (T0), after ten months (T1), and after 24 months (T2).","['Subjects were recruited from a population of 423 students', 'One intervention group and one control group were recruited from two campuses at a Norwegian university offering a Bachelor of Nursing degree', ""Bachelor of Nursing students' attitudes toward teamwork in health care"", ""nursing students' attitudes toward teamwork in healthcare""]","['TeamSTEPPS® team training intervention', 'control group responded to the Norwegian version of the TeamSTEPPS® Teamwork Attitude Questionnaire (T-TAQ', 'TeamSTEPPS® team training program with various learning activities to enhance teamwork skills']","['mean score', 'Total T-TAQ score']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",423.0,0.00824938,"The intervention group and the control group responded to the Norwegian version of the TeamSTEPPS® Teamwork Attitude Questionnaire (T-TAQ) before the intervention (T0), after ten months (T1), and after 24 months (T2).","[{'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Karlsen', 'Affiliation': 'Norwegian University of Science and Technology (NTNU) Faculty of Medicine and Health Sciences, Department of Health Sciences in Gjøvik, Norway. Electronic address: tore.karlsen@ntnu.no.'}, {'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Hall-Lord', 'Affiliation': 'Norwegian University of Science and Technology (NTNU) Faculty of Medicine and Health Sciences, Department of Health Sciences in Gjøvik, Norway; Faculty of Health, Science and Technology, Department of Health Sciences, Karlstad University, Karlstad, Sweden.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Wangensteen', 'Affiliation': 'Norwegian University of Science and Technology (NTNU) Faculty of Medicine and Health Sciences, Department of Health Sciences in Gjøvik, Norway.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Ballangrud', 'Affiliation': 'Norwegian University of Science and Technology (NTNU) Faculty of Medicine and Health Sciences, Department of Health Sciences in Gjøvik, Norway.'}]",Nurse education today,['10.1016/j.nedt.2021.105180']
2108,34717164,Impact of Dance Movement Psychotherapy on the wellbeing of caregivers of children with Autism Spectrum Disorder.,"OBJECTIVES


Sustaining the wellbeing of caregivers of children with Autism Spectrum Disorder (ASD) can be highly demanding. This study explored the impact of Dance Movement Psychotherapy (DMP) intervention on the wellbeing of caregivers in comparison with their standard care routine.
STUDY DESIGN


This pilot evaluation study used a quasi-experimental design.
METHODS


Thirty-seven caregivers of children with ASD were recruited from two special educational needs settings and were allocated to the DMP intervention or the control group depending on their availability to attend the sessions. The participants in the intervention group received five DMP sessions lasting 90 min each. Adult Wellbeing Scale (AWS) and Parenting Stress Index-Short Form (PSI-SF) were the two outcome measures administered before and after DMP to measure the impact of DMP intervention on caregivers' wellbeing and parental stress.
RESULTS


The retention rates were poor, with only 50% of participants in the DMP intervention arm attending at least 70% of the sessions until its end. The Minimal Clinically Important Difference (MCID) was achieved for a small effect size in both outcome measures in the DMP intervention group but not in the control group. Results from the Analyses of Covariance (ANCOVAs) showed a significant difference in post-intervention scores between the DMP intervention and the control group for AWS (F 1,33  = 106.474, P < 0.001) but not for PSI-SF. In addition, a significant association was found between pre-intervention scores and the number of sessions attended with the postintervention scores of both AWS and PSI-SF.
CONCLUSIONS


The results of this pilot DMP study are promising. However, before running a larger randomised controlled trial, strategies to support caregivers to attend the intervention need to be considered carefully.",2021,"Results from the Analyses of Covariance (ANCOVAs) showed a significant difference in post-intervention scores between the DMP intervention and the control group for AWS (F 1,33  = 106.474, P < 0.001) but not for PSI-SF.","['caregivers of children with Autism Spectrum Disorder (ASD', 'Thirty-seven caregivers of children with ASD were recruited from two special educational needs settings', 'caregivers in comparison with their standard care routine', 'caregivers of children with Autism Spectrum Disorder']","['five DMP sessions lasting 90\xa0min each', 'Dance Movement Psychotherapy (DMP) intervention', 'DMP intervention', 'Dance Movement Psychotherapy']","['Adult Wellbeing Scale (AWS) and Parenting Stress Index-Short Form (PSI-SF', ""caregivers' wellbeing and parental stress"", 'retention rates', 'post-intervention scores']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0591705,"Results from the Analyses of Covariance (ANCOVAs) showed a significant difference in post-intervention scores between the DMP intervention and the control group for AWS (F 1,33  = 106.474, P < 0.001) but not for PSI-SF.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Aithal', 'Affiliation': 'Research Centre for Arts and Wellbeing, Edge Hill University, Ormskirk, United Kingdom; Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom. Electronic address: supritha.aithal@gmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Karkou', 'Affiliation': 'Research Centre for Arts and Wellbeing, Edge Hill University, Ormskirk, United Kingdom; Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Makris', 'Affiliation': 'Research Centre for Arts and Wellbeing, Edge Hill University, Ormskirk, United Kingdom; Department of Psychology, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Karaminis', 'Affiliation': 'Research Centre for Arts and Wellbeing, Edge Hill University, Ormskirk, United Kingdom; Department of Psychology, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'Research Centre for Arts and Wellbeing, Edge Hill University, Ormskirk, United Kingdom; Department of Psychology, Edge Hill University, Ormskirk, United Kingdom.'}]",Public health,['10.1016/j.puhe.2021.09.018']
2109,34717168,The effect of an empowerment program on the moral sensitivity and caring behaviors of emergency nurses in Iran.,"AIM


The present study aimed to evaluate the effect of an empowerment program on the moral sensitivity and caring behaviors of nurses in emergency departments in Iran.
BACKGROUND


Emergency department is often a high stress environment. Nurses who worked in the emergency departments are expected to work under pressure to many standards, guidelines and protocols related to patient care. It will expose emergency department nurses to psychological pressures and moral conflicts. A nurse's sensitivity to ethical issues is necessary to provide humane care; it is considered to be a professional competence for nurses.
METHODS


This study had a controlled quasi-experimental design. Data were collected before, immediately after, and 1 month after the intervention using a moral sensitivity questionnaire and a caring behavior questionnaire. A total of 131 emergency department nurses from 4 teaching hospitals were divided into an intervention group and a control group. The intervention group received six 60-minute training sessions; the control group did not receive the training.
RESULTS


The mean moral sensitivity and caring behavior scores for both groups increased significantly immediately and 1 month after the intervention. However, the significance was higher in the intervention group than in the control group. A comparison of the mean moral sensitivity and caring behavior scores between the groups immediately and 1 month after the intervention did not show a statistically significant difference.
CONCLUSIONS


Implementing a training program on ethical issues could thus have a significant impact on the clinical performance of nurses, which could be maintained through follow-up.",2021,"A comparison of the mean moral sensitivity and caring behavior scores between the groups immediately and 1 month after the intervention did not show a statistically significant difference.
","['131 emergency department nurses from 4 teaching hospitals', 'emergency nurses in Iran', 'Nurses who worked in the emergency departments']","['six 60-minute training sessions; the control group did not receive the training', 'empowerment program']",['mean moral sensitivity and caring behavior scores'],"[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0557351', 'cui_str': 'Employed'}]","[{'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.00939942,"A comparison of the mean moral sensitivity and caring behavior scores between the groups immediately and 1 month after the intervention did not show a statistically significant difference.
","[{'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Bagherzadeh', 'Affiliation': 'Student Research Committee, Nasibeh Nursing and Midwifery Faculty, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hedayat', 'Initials': 'H', 'LastName': 'Jafari', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Jamshid Yazdani', 'Initials': 'JY', 'LastName': 'Charati', 'Affiliation': 'Department of Biostatistics, Faculty of Health, Health Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Shafipour', 'Affiliation': 'Department of Medical-Surgical Nursing, Nasibeh Nursing and Midwifery Faculty, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: v.shafipour@mazums.ac.ir.'}]",Nurse education in practice,['10.1016/j.nepr.2021.103243']
2110,34717154,Characterization of the immune response in patients with cancer of the oral cavity after neoadjuvant immunotherapy with the IRX-2 regimen.,"OBJECTIVE


IRX-2 is a homologous cell-derived multi-cytokine biologic with multifaceted immune modulatory effects that has been shown to induce increased lymphocyte infiltration into primary tumors in oral cavity carcinoma. Our objective was to characterize tumor immune gene expression and epigenomic changes after neoadjuvant IRX-2 immunotherapy in patients with squamous cell carcinoma of the oral cavity.
METHODS


A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery for previously untreated patients with Stage II-IV oral cavity carcinoma. The treatment regimen consisted of low dose (300 mg/m 2 ) cyclophosphamide (day 1) followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without the IRX-2 cytokines (Regimen 2). The NanoString immune panel (730 genes) and Infinium MethylationEPIC BeadChip were performed to assess the gene expression and DNA methylation signatures, respectively, in pre- and post-immunotherapy tumor samples.
RESULTS


A total of 51 and 79 immune-related genes were found upregulated and downregulated, respectively, in the samples from Regimen 1 patients after treatment, while 51 and 56 were found upregulated and downregulated in the samples for Regimen 2. When comparing the changes between the two regimens, we identified 9 genes significantly different, including DMBT1, a potential tumor suppressor, functioning in tumor invasion of head and neck cancer. The exploration of DNA methylation showed slight overall hypermethylation after treatment in both regimens, especially for Regimen 1 immune responders, and methylation-based cell type deconvolution demonstrated high concordance with tumor infiltrating T lymphocyte cell counts.
CONCLUSION


While a consistent patient response after treatment was observed, most changes were similar between regimens, indicating a subtle, targeted, or patient-specific effect of IRX-2 cytokines. Change in DMBT1 expression was a unique finding that will require further study to better understand its significance.",2021,"The exploration of DNA methylation showed slight overall hypermethylation after treatment in both regimens, especially for Regimen 1 immune responders, and methylation-based cell type deconvolution demonstrated high concordance with tumor infiltrating T lymphocyte cell counts.
","['patients with cancer of the oral cavity after neoadjuvant immunotherapy with the IRX-2 regimen', 'previously untreated patients with Stage II-IV oral cavity carcinoma', 'patients with squamous cell carcinoma of the oral cavity']","['IRX-2', 'cyclophosphamide', 'neoadjuvant IRX-2 immunotherapy', 'regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole']","['DMBT1, a potential tumor suppressor, functioning in tumor invasion of head and neck cancer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0151546', 'cui_str': 'Mouth carcinoma'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}]","[{'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}]","[{'cui': 'C0665820', 'cui_str': 'DMBT1 protein, human'}, {'cui': 'C0079427', 'cui_str': 'Antioncogene'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]",,0.0771134,"The exploration of DNA methylation showed slight overall hypermethylation after treatment in both regimens, especially for Regimen 1 immune responders, and methylation-based cell type deconvolution demonstrated high concordance with tumor infiltrating T lymphocyte cell counts.
","[{'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Computational Medicine and Bioinformatics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zarins', 'Affiliation': 'Department of Environmental Health Sciences, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': ""D'Silva"", 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan, Ann Arbor, MI 48104, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rozek', 'Affiliation': 'Department of Environmental Health Sciences, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Wolf', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Michigan Medicine, Ann Arbor, MI, USA. Electronic address: gregwolf@med.umich.edu.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Sartor', 'Affiliation': 'Department of Computational Medicine and Bioinformatics, University of Michigan, Ann Arbor, MI, USA; Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA. Electronic address: sartorma@umich.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oral oncology,['10.1016/j.oraloncology.2021.105587']
2111,34717099,"The impact of three-dimensional visualisation on midwifery student learning, compared with traditional education for teaching the third stage of labour: A pilot randomised controlled trial.","BACKGROUND


Complex physiological processes are often difficult for midwifery students to comprehend when using traditional teaching and learning approaches. Face to face instructional workshops using simulation have had some impact on improving understanding. However, in the 21st century new technologies offer the opportunity to provide alternative learning approaches.
AIM


To investigate the impact of using three-dimensional (3D) visualisation in midwifery education on student's experience of learning, and retention of knowledge at three points in time.
DESIGN


A pilot study involving a two-armed parallel Randomised Controlled Trial (RCT) comparing the retention of knowledge scores between the control and intervention groups.
SETTING


An Australian University in the Northern Territory.
PARTICIPANTS


The sample included second year Bachelor of Midwifery students (n = 38). All received traditional midwifery education before being randomly allocated to either the intervention (n = 20) or control (n = 18) group.
METHODS


A new immersive virtual environment was introduced to complement existing traditional midwifery education on the third stage of labour. This intervention was evaluated using a demographic survey and multiple-choice questionnaire to collect baseline information via Qualtrics. To measure change in knowledge and comprehension, participants completed the same multiple-choice knowledge questionnaire at three time points; pre, immediately post and at 1 month post intervention. In addition, the intervention group completed a 3D student satisfaction survey.
RESULTS


Baseline knowledge scores were similar between the groups. A statistically significant increase in knowledge score was evident immediately post intervention for the intervention group, however there was no significant difference in knowledge score at one month.
CONCLUSIONS


The results support the creation of further three-dimensional visualisation teaching resources for midwifery education. However, a larger randomised controlled study is needed to seek generalisation of these findings to confirm enhanced student learning and retention of knowledge post 3DMVR, beyond the immediate exposure time.",2021,"A statistically significant increase in knowledge score was evident immediately post intervention for the intervention group, however there was no significant difference in knowledge score at one month.
",['An Australian University in the Northern Territory'],[],"['retention of knowledge scores', 'knowledge score']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0028416', 'cui_str': 'Northern Territory'}]",[],"[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.019129,"A statistically significant increase in knowledge score was evident immediately post intervention for the intervention group, however there was no significant difference in knowledge score at one month.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Gray', 'Affiliation': 'College of Nursing and Midwifery, Charles Darwin University, Darwin, Northern Territory, Australia; School of Nursing and Midwifery, Edith Cowan University, Western Australia, Australia. Electronic address: michelle.gray@ecu.edu.au.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Downer', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hartz', 'Affiliation': 'College of Nursing and Midwifery, Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Patrea', 'Initials': 'P', 'LastName': 'Andersen', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Queensland, Australia; Centre for Health and Social Practice, Waikato Institute of Technology, Hamilton, New Zealand.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hanson', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'College of Nursing and Midwifery, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Nurse education today,['10.1016/j.nedt.2021.105184']
2112,34731779,Preservation of Sexual Function 5 Years After Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia.,"BACKGROUND


Erectile dysfunction (ED) and ejaculatory dysfunction (EjD) are known outcomes of traditional surgery and some pharmacotherapies for treatment of benign prostatic hyperplasia (BPH). Minimally invasive treatment options, including water vapor thermal therapy (WVTT), are now available to treat lower urinary tract symptoms (LUTS) due to BPH.
AIM


The objective of this analysis was to evaluate long-term impact of a single water vapor thermal therapy procedure on erectile and ejaculatory function in subjects enrolled in the Rezum II prospective, multicenter, randomized, blinded controlled trial.
METHODS


Fifteen centers enrolled 197 subjects with International Prostate Symptom Score (IPSS) ≥ 13, maximum flow rate (Qmax) ≤ 15 mL/s, and prostate volume 30-80 cc. Subjects were randomized (2:1) to (WVTT) or sham procedure (control) and followed for 5 years. Erectile and ejaculatory functions were quantitatively assessed at baseline and yearly thereafter. After 3 months, control subjects could opt to requalify for cross-over to WVTT and were followed for 5 years. Results of the per protocol analysis were reported previously. The current post hoc analysis was performed on all treated subjects who were sexually active at baseline with no other surgical or medical management for BPH during the 5-year study period.
OUTCOMES


LUTS was evaluated using IPSS, Benign Prostatic Hyperplasia Impact Index (BPHII), and Qmax. Sexual function was assessed using the International Index of Erectile Function (IIEF-EF) and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD).
RESULTS


A total of 197 subjects (136 treated, 61 control) were enrolled in the study, and 53 control subjects opted to cross-over and receive WVTT. All subgroups experienced significant, durable improvement in IPSS (P < .0001). Subjects with normal sexual function at baseline had little change in function over 5 years (IIEF-EF: -2.4 ± 8.9, P = .1414; MSHQ-EjD Function: -1.6 ± 3.2, P = .0083; MSHQ-EjD Bother: -0.5 ± 1.6, P = .1107). Subjects with baseline medical history of ED and EjD showed slight decline over time that was not clinically significant (ED, IIEF-EF: -3.0 ± 10.1, P = .1259; MSHQ EjD Function: -2.3 ± 4.7, P = .0158; MSHQ-EjD Bother: -0.1 ± 2.6, P = .7764; EjD, IIEF-EF: -4.1 ± 9.2, P = .0127; MSHQ EjD Function: -1.6 ± 4.8, P = .1970; MSHQ-EjD Bother: -0.4 ± 2.6, P = .440).
CLINICAL IMPLICATIONS


Treatment for BPH with Rezum durably improved IPSS without clinically significant impact on sexual function. Patients with baseline ED/EjD may expect continued decline from other causes but are unimpacted by the therapy.
STRENGTHS & LIMITATIONS, CONCLUSION


The results are limited by the post-hoc nature of the analysis and attrition over the 5-year follow-up but provide long-term evidence of durable outcomes after treatment with Rezum without impact on sexual function scores. McVary KT, El-Arabi A, Roehrborn C. Preservation of Sexual Function 5 Years After Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia. Sex Med 2021;9:100454.",2021,"MSHQ-EjD Bother: -0.5 ± 1.6, P = .1107).","['Fifteen centers enrolled 197 subjects with International Prostate Symptom Score (IPSS) ≥ 13, maximum flow rate (Qmax) ≤ 15 mL/s, and prostate volume 30-80 cc', 'benign prostatic hyperplasia (BPH', 'Sexual Function 5 Years', 'Benign Prostatic Hyperplasia', 'subjects enrolled in the Rezum II prospective', 'treated subjects who were sexually active at baseline with no other surgical or medical management for BPH during the 5-year study period', '197 subjects (136 treated, 61 control) were enrolled in the study, and 53 control subjects opted to']","['single water vapor thermal therapy procedure', 'Water Vapor Thermal Therapy', 'cross-over and receive WVTT', 'water vapor thermal therapy (WVTT']","['IPSS', 'sexual function scores', 'International Index of Erectile Function (IIEF-EF) and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD', 'IPSS, Benign Prostatic Hyperplasia Impact Index (BPHII), and Qmax', 'erectile and ejaculatory function', 'Sexual function', 'sexual function', 'Erectile and ejaculatory functions']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439390', 'cui_str': 'mL/s'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C2350022', 'cui_str': 'Water Vapor'}, {'cui': 'C0454527', 'cui_str': 'Thermal techniques'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0235969', 'cui_str': 'Disorder of ejaculation'}, {'cui': 'C3472216', 'cui_str': 'Benign prostatic hyperplasia impact index'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",197.0,0.0608824,"MSHQ-EjD Bother: -0.5 ± 1.6, P = .1107).","[{'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'McVary', 'Affiliation': 'Stritch School of Medicine, Loyola University Medical Center, Maywood, IL, USA. Electronic address: kmcvary@gmail.com.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'El-Arabi', 'Affiliation': 'Stritch School of Medicine, Loyola University Medical Center, Maywood, IL, USA.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Roehrborn', 'Affiliation': 'UT Southwestern Medical Center, Urology, Dallas, TX, USA.'}]",Sexual medicine,['10.1016/j.esxm.2021.100454']
2113,34724240,Safety of intravenous arginine therapy in children with sickle cell disease hospitalized for vaso-occlusive pain: A randomized placebo-controlled trial in progress.,,2021,,['Children with Sickle Cell Disease Hospitalized for Vaso-occlusive Pain'],"['Intravenous Arginine Therapy', 'Placebo']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.657582,,"[{'ForeName': 'Loretta Z', 'Initials': 'LZ', 'LastName': 'Reyes', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Figueroa', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Leake', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, Georgia, USA.""}, {'ForeName': 'Kirshma', 'Initials': 'K', 'LastName': 'Khemani', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Kumari', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Lane', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Carlton', 'Initials': 'C', 'LastName': 'Dampier', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Morris', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",American journal of hematology,['10.1002/ajh.26396']
2114,34724213,The Effect of Povidone-Iodine Nasal Spray on Nasopharyngeal SARS-CoV-2 Viral Load: A Randomized Control Trial.,"OBJECTIVES/HYPOTHESIS


To determine the effect of povidone-iodine (PVP-I) nasal sprays on nasopharyngeal (NP) viral load as assessed by cycle threshold (Ct) on quantitative polymerase chain reaction (qPCR) of SARS-CoV-2 in outpatients.
STUDY DESIGN


Three arm, triple blinded, randomized, placebo-controlled clinical trial.
METHODS


Participants were randomized within 5 days of testing positive for COVID-19 to receive nasal sprays containing placebo (0.9% saline), 0.5% PVP-I, or 2.0% PVP-I. NP swabs for qPCR analysis were taken at baseline, 1-hour post-PVP-I spray (two sprays/nostril), and 3 days post-PVP-I spray (20 sprays/nostril). Symptom and adverse event questionnaires were completed at baseline, day 3, and day 5. University of Pennsylvania Smell Identification Tests (UPSIT) were completed at baseline and day 30.
RESULTS


Mean Ct values increased over time in all groups, indicating declining viral loads, with no statistically significant difference noted in the rate of change between placebo and PVP-I groups. The 2.0% PVP-I group showed statistically significant improvement in all symptom categories; however, it also reported a high rate of nasal burning. Olfaction via UPSIT showed improvement by at least one category in all groups. There were no hospitalizations or mortalities within 30 days of study enrollment.
CONCLUSIONS


Saline and low concentration PVP-I nasal sprays are well tolerated. Similar reductions in SARS-CoV-2 NP viral load were seen over time in all groups. All treatment groups showed improvement in olfaction over 30 days. These data suggest that dilute versions of PVP-I nasal spray are safe for topical use in the nasal cavity, but that PVP-I does not demonstrate virucidal activity in COVID-19 positive outpatients.
LEVEL OF EVIDENCE


II Laryngoscope, 2021.",2021,"RESULTS


Mean cycle threshold (Ct) values increased over time in all groups, indicating declining viral loads, with no statistically significant difference noted in the rate of change between placebo and PVP-I groups.","['outpatients', 'Participants', 'Patients']","['povidone-iodine (PVP-I) nasal sprays', 'Povidone-Iodine Nasal Spray', 'PVP-I nasal sprays', 'Saline and low concentration', 'nasal sprays containing either placebo (0.9% saline), 0.5% PVP-I, or 2.0% PVP-I. NP swabs for qPCR analysis were taken at baseline, 1-hour post-PVP-I spray (2 sprays/nostril), and 3\u2009days post-PVP', 'placebo']","['hospitalizations or mortalities', 'tolerated', 'olfaction', 'COVID-19 Nasopharyngeal Viral Load', 'SARS-CoV-2 nasopharyngeal viral load', 'Mean cycle threshold (Ct) values', 'Symptom and adverse event questionnaires', 'rate of nasal burning']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0200931', 'cui_str': 'Polymerase chain reaction analysis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0542101', 'cui_str': 'Nasal burning'}]",,0.258525,"RESULTS


Mean cycle threshold (Ct) values increased over time in all groups, indicating declining viral loads, with no statistically significant difference noted in the rate of change between placebo and PVP-I groups.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zarabanda', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'Neelaysh', 'Initials': 'N', 'LastName': 'Vukkadala', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Phillips', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati School of Medicine, Cincinnati, Ohio, U.S.A.'}, {'ForeName': 'Z Jason', 'Initials': 'ZJ', 'LastName': 'Qian', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'Kenji O', 'Initials': 'KO', 'LastName': 'Mfuh', 'Affiliation': 'Clinical Virology Laboratory, Stanford Health Care, Stanford, California, U.S.A.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hatter', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'Ivan T', 'Initials': 'IT', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'Vidya K', 'Initials': 'VK', 'LastName': 'Rao', 'Affiliation': 'Divisions of Cardiothoracic Anesthesiology and Critical Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Hwang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Domb', 'Affiliation': 'Shasta-ENT Medical Group, Redding, California, U.S.A.'}, {'ForeName': 'Zara M', 'Initials': 'ZM', 'LastName': 'Patel', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Pinsky', 'Affiliation': 'Clinical Virology Laboratory, Stanford Health Care, Stanford, California, U.S.A.'}, {'ForeName': 'Jayakar V', 'Initials': 'JV', 'LastName': 'Nayak', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}]",The Laryngoscope,['10.1002/lary.29935']
2115,34724205,Magnetic resonance imaging system for intraoperative margin assessment for DCIS and invasive breast cancer using the ClearSight™ system in breast-conserving surgery-Results from a postmarketing study.,"BACKGROUND AND OBJECTIVES


Breast-conserving surgery (BCS) is followed by reoperations in approximately 25%. Reoperations lead to an increased risk of infection and wound healing problems as well as a worse cosmetic outcome. Several technical approaches for an intraoperative margin assessment to decrease the reoperation rate are under evaluation, some of them are still experimental.
METHODS


A prospective single-arm post-marketing study with 60 patients undergoing BCS for ductal carcinoma in situ (DCIS) and invasive breast cancer was conducted. The specimen was intraoperatively examined by the ClearSight™ system, a mobile magnetic resonance imaging system that is based on a diffusion-weighted imaging protocol. However, the results were blinded to the surgeon.
RESULTS


The ClearSight™ system was performed for both ductal and lobular breast cancer and DCIS, with a sensitivity of 0.80 (95% confidence interval [CI]: 0.44-0.96) and a specificity of 0.84 (95% CI 0.72-0.92), with an overall diagnostic accuracy of 80%.
CONCLUSION


Had the ClearSight™ been known to the surgeon intraoperatively, the reoperation rate would have been reduced by 83% for invasive carcinoma, from 10% to 2%, and 50% for DCIS, from 30% to 15% reoperations. A trial designed to examine the impact on reoperation rates is currently ongoing.",2021,"Had the ClearSight™ been known to the surgeon intraoperatively, the reoperation rate would have been reduced by 83% for invasive carcinoma, from 10% to 2%, and 50% for DCIS, from 30% to 15% reoperations.",['60 patients undergoing BCS for ductal carcinoma in situ (DCIS) and invasive breast cancer'],"['Magnetic resonance imaging system', 'Breast-conserving surgery (BCS']","['risk of infection and wound healing problems', 'reoperation rate', 'reoperation rates', 'overall diagnostic accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}]","[{'cui': 'C0336660', 'cui_str': 'Magnetic resonance imaging unit'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",60.0,0.522165,"Had the ClearSight™ been known to the surgeon intraoperatively, the reoperation rate would have been reduced by 83% for invasive carcinoma, from 10% to 2%, and 50% for DCIS, from 30% to 15% reoperations.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Thill', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Szwarcfiter', 'Affiliation': 'Clear-Cut Medical Ltd., Rehovot, Israel.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kelling', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'van Haasteren', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Kolka', 'Affiliation': 'Clear-Cut Medical Ltd., Rehovot, Israel.'}, {'ForeName': 'Josefa', 'Initials': 'J', 'LastName': 'Noelke', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}, {'ForeName': 'Zachi', 'Initials': 'Z', 'LastName': 'Peles', 'Affiliation': 'Clear-Cut Medical Ltd., Rehovot, Israel.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Papa', 'Affiliation': 'General Surgery Unit, Assuta Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Aulmann', 'Affiliation': 'OptiPath, Frankfurt, Germany.'}, {'ForeName': 'Tanir', 'Initials': 'T', 'LastName': 'Allweis', 'Affiliation': 'Medical Director, Breast Health Center, Kaplan Medical Cente, Rehovot, Israel.'}]",Journal of surgical oncology,['10.1002/jso.26721']
2116,34728250,App-based food-specific inhibitory control training as an adjunct to treatment as usual in binge-type eating disorders: A feasibility trial.,"Current treatments for binge eating disorder (BED) and bulimia nervosa (BN) only show moderate efficacy, warranting the need for novel interventions. Impairments in food-related inhibitory control contribute to BED/BN and could be targeted by food-specific inhibitory control training (ICT). The aim of this study was to establish the feasibility and acceptability of augmenting treatment for individuals with BN/BED with an ICT app (FoodT), which targets motor inhibition to food stimuli using a go/no-go paradigm. Eighty patients with BED/BN receiving psychological and/or pharmacological treatment were randomly allocated to a treatment-as-usual group (TAU; n = 40) or TAU augmented with the 5-min FoodT app daily (n = 40) for 4 weeks. This mixed-methods study assessed feasibility outcomes, effect sizes of clinical change, and acceptability using self-report measures. Pre-registered cut-offs for recruitment, retention, and adherence were met, with 100% of the targeted sample size (n = 80) recruited within 12 months, 85% of participants retained at 4 weeks, and 80% of the FoodT + TAU group completing ≤8 sessions. The reduction in binge eating did not differ between groups. However, moderate reductions in secondary outcomes (eating disorder psychopathology: SES = -0.57, 95% CI [-1.12, -0.03]; valuation of high energy-dense foods: SES = -0.61, 95% CI [-0.87, -0.05]) were found in the FoodT group compared to TAU. Furthermore, small greater reductions in food addiction (SES = -0.46, 95% CI [-1.14, 0.22]) and lack of premeditation (SES = -0.42, 95% CI [-0.77, -0.07]) were found in the FoodT group when compared to TAU. The focus groups revealed acceptability of FoodT. Participants discussed personal barriers (e.g. distractions) and suggested changes to the app (e.g. adding a meditation exercise). Augmenting treatment for BED/BN with a food-specific ICT app is feasible, acceptable, and may reduce clinical symptomatology with high reach and wide dissemination.",2021,Impairments in food-related inhibitory control contribute to BED/BN and could be targeted by food-specific inhibitory control training (ICT).,"['binge eating disorder (BED) and bulimia nervosa (BN', 'Eighty patients with BED/BN receiving psychological and/or pharmacological treatment', 'binge-type eating disorders', 'individuals with BN/BED with an ICT app (FoodT']","['treatment-as-usual group (TAU; n\xa0=\xa040) or TAU augmented with the 5-min FoodT app daily', 'App-based food-specific inhibitory control training']","['feasibility and acceptability', 'food addiction', 'binge eating']","[{'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}]",80.0,0.0819433,Impairments in food-related inhibitory control contribute to BED/BN and could be targeted by food-specific inhibitory control training (ICT).,"[{'ForeName': 'Johanna Louise', 'Initials': 'JL', 'LastName': 'Keeler', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. Electronic address: johanna.keeler@kcl.ac.uk.""}, {'ForeName': 'Rayane', 'Initials': 'R', 'LastName': 'Chami', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cardi', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK; Department of General Psychology, University of Padova, Padova, Italy.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': ""Department of Biostatistics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Bonin', 'Affiliation': 'Care Policy and Evaluation Centre, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'MacDonald', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Lawrence', 'Affiliation': 'School of Psychology, University of Exeter, Exeter, Devon, UK.'}]",Appetite,['10.1016/j.appet.2021.105788']
2117,34723857,Geographic diversity in authorship of HIV randomized control trial publications.,,2021,,[],[],[],[],[],[],,0.145788,,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics and Epidemiology.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McGovern', 'Affiliation': 'Department of Health Behavior, Society and Policy, Rutgers School of Public Health, Piscataway, NJ, USA.'}, {'ForeName': 'Yaya', 'Initials': 'Y', 'LastName': 'Togo', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.'}]","AIDS (London, England)",['10.1097/QAD.0000000000003038']
2118,34724251,"Roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndrome: Open-label, dose-selection, lead-in stage of a phase 3 study.","Anemia is the predominant cytopenia in myelodysplastic syndromes (MDS) and treatment options are limited. Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor approved for the treatment of anemia of chronic kidney disease in the UK, EU, China, Japan, South Korea, and Chile. MATTERHORN is a phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of roxadustat in anemia of lower risk-MDS. Eligible patients had baseline serum erythropoietin ≤ 400 mIU/mL, and a low packed RBC transfusion burden. In this open-label (OL), dose-selection, lead-in phase, enrolled patients were assigned to 1 of 3 roxadustat starting doses (n = 8 each): 1.5, 2.0, and 2.5 mg/kg. The primary efficacy endpoint of the OL phase was the proportion of patients with transfusion independence (TI) for ≥ 8 consecutive weeks in the first 28 treatment weeks. A secondary efficacy endpoint was the proportion of patients with a ≥ 50% reduction in RBC transfusions over an 8-week period compared with baseline. Adverse events were monitored. Patients were followed for 52 weeks. Of the 24 treated patients, TI was achieved in 9 patients (37.5%) at 28 and 52 weeks; 7 of these patients were receiving 2.5 mg/kg dose when TI was achieved. A ≥ 50% reduction in RBC transfusions was achieved in 54.2% and 58.3% of patients at 28 and 52 weeks, respectively. Oral roxadustat dosed thrice weekly was well tolerated. There were no fatalities or progression to acute myeloid leukemia. Based on these outcomes, 2.5 mg/kg was the chosen starting roxadustat dose for the ongoing double-blind study phase.",2021,"A ≥50% reduction in RBC transfusions was achieved in 54.2% and 58.3% of patients at 28 and 52 weeks, respectively.","['Eligible patients had baseline serum erythropoietin ≤400 mIU/mL, and a low packed RBC transfusion burden', 'Patients with Lower-Risk Myelodysplastic Syndrome']",['placebo'],"['proportion of patients with transfusion independence (TI', 'tolerated', 'Adverse events', 'RBC transfusions', 'fatalities or progression to acute myeloid leukemia', 'efficacy and safety']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.180272,"A ≥50% reduction in RBC transfusions was achieved in 54.2% and 58.3% of patients at 28 and 52 weeks, respectively.","[{'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Henry', 'Affiliation': 'Pennsylvania Hospital, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glaspy', 'Affiliation': 'UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Harrup', 'Affiliation': 'Royal Hobart Hospital, Tasmania, Australia.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Mittelman', 'Affiliation': 'Tel-Aviv Sourasky Medical Center, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Zhou', 'Affiliation': 'Washington University School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Hetty E', 'Initials': 'HE', 'LastName': 'Carraway', 'Affiliation': 'Leukemia Program, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Bradley', 'Affiliation': 'FibroGen Inc, San Francisco, California, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Saha', 'Affiliation': 'FibroGen Inc, San Francisco, California, USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Modelska', 'Affiliation': 'FibroGen Inc, San Francisco, California, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Bartels', 'Affiliation': 'FibroGen Inc, San Francisco, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Leong', 'Affiliation': 'FibroGen Inc, San Francisco, California, USA.'}, {'ForeName': 'Kin-Hung P', 'Initials': 'KP', 'LastName': 'Yu', 'Affiliation': 'FibroGen Inc, San Francisco, California, USA.'}]",American journal of hematology,['10.1002/ajh.26397']
2119,34715838,Improvement of osteoporosis Care Organized by Nurses: ICON study - Protocol of a quasi-experimental study to assess the (cost)-effectiveness of combining a decision aid with motivational interviewing for improving medication persistence in patients with a recent fracture being treated at the fracture liaison service.,"BACKGROUND


Given the health and economic burden of fractures related to osteoporosis, suboptimal adherence to medication and the increasing importance of shared-decision making, the Improvement of osteoporosis Care Organized by Nurses (ICON) study was designed to evaluate the effectiveness, cost-effectiveness and feasibility of a multi-component adherence intervention (MCAI) for patients with an indication for treatment with anti-osteoporosis medication, following assessment at the Fracture Liaison Service after a recent fracture. The MCAI involves two consultations at the FLS. During the first consultation, a decision aid is will be used to involve patients in the decision of whether to start anti-osteoporosis medication. During the follow-up visit, the nurse inquires about, and stimulates, medication adherence using motivational interviewing techniques.
METHODS


A quasi-experimental trial to evaluate the (cost-) effectiveness and feasibility of an MCAI, consisting of a decision aid (DA) at the first visit, combined with nurse-led adherence support using motivational interviewing during the follow-up visit, in comparison with care as usual, in improving adherence to oral anti-osteoporosis medication for patients with a recent fracture two Dutch FLS. Medication persistence, defined as the proportion of patients who are persistent at one year assuming a refill gap < 30 days, is the primary outcome. Medication adherence, decision quality, subsequent fractures and mortality are the secondary outcomes. A lifetime cost-effectiveness analysis using a model-based economic evaluation and a process evaluation will also be conducted. A sample size of 248 patients is required to show an improvement in the primary outcome with 20%. Study follow-up is at 12 months, with measurements at baseline, after four months, and at 12 months.
DISCUSSION


We expect that the ICON-study will show that the MCAI is a (cost-)effective intervention for improving persistence with anti-osteoporosis medication and that it is feasible for implementation at the FLS.
TRIAL REGISTRATION


This trial has been registered in the Netherlands Trial Registry, part of the Dutch Cochrane Centre (Trial NL7236 (NTR7435)). Version 1.0; 26-11-2020.",2021,"During the follow-up visit, the nurse inquires about, and stimulates, medication adherence using motivational interviewing techniques.
","['patients with a recent fracture being treated at the fracture liaison service', 'patients with a recent fracture two Dutch FLS', '248 patients', 'patients with an indication for treatment with anti-osteoporosis medication, following assessment at the Fracture Liaison Service after a recent fracture']","['oral anti-osteoporosis medication', 'MCAI, consisting of a decision aid (DA', 'multi-component adherence intervention (MCAI', 'decision aid with motivational interviewing']","['Medication adherence, decision quality, subsequent fractures and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0687831,"During the follow-up visit, the nurse inquires about, and stimulates, medication adherence using motivational interviewing techniques.
","[{'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Cornelissen', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Maastricht University, P.O. Box 616, 6200, MD, Maastricht, The Netherlands. d.cornelissen@maastrichtuniversity.nl.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Boonen', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center; and Care and Public Health Research Institute (CAPHRI), Maastricht, The Netherlands.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Evers', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Maastricht University, P.O. Box 616, 6200, MD, Maastricht, The Netherlands.'}, {'ForeName': 'Joop P', 'Initials': 'JP', 'LastName': 'van den Bergh', 'Affiliation': 'Department of Internal Medicine, VieCuri Medical Center, Venlo, The Netherlands.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Bours', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Maastricht University, P.O. Box 616, 6200, MD, Maastricht, The Netherlands.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Wyers', 'Affiliation': 'Department of Internal Medicine, VieCuri Medical Center, Venlo, The Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'van Oostwaard', 'Affiliation': 'Department of Internal Medicine, VieCuri Medical Center, Venlo, The Netherlands.'}, {'ForeName': 'Trudy', 'Initials': 'T', 'LastName': 'van der Weijden', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': 'Hiligsmann', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Maastricht University, P.O. Box 616, 6200, MD, Maastricht, The Netherlands.'}]",BMC musculoskeletal disorders,['10.1186/s12891-021-04743-2']
2120,34726606,"Examining the Effectiveness of 3D Virtual Reality Training on Problem-solving, Self-efficacy, and Teamwork Among Inexperienced Volunteers Helping With Drug Use Prevention: Randomized Controlled Trial.","BACKGROUND


Illegal drug usage among adolescents is a critical health problem. The Taiwanese government provides an accompanying volunteer program to prevent students who experiment with drugs from reusing them. An appropriate training program can improve volunteers' abilities to assist students using drugs. Problem-solving, self-efficacy, and teamwork are critical abilities for inexperienced volunteers who help with drug use prevention. By interacting with the animation or 3D virtual reality (VR) in the virtual scene, learners can immerse themselves in the virtual environment to learn, and 3D VR can increase learning opportunities and reduce the cost of human and material resources.
OBJECTIVE


The aim of this study was to examine the effectiveness of spherical video-based virtual reality (SVVR) training in improving problem-solving, self-efficacy, and teamwork among volunteers who helped prevent adolescents from using illegal drugs.
METHODS


This study used a randomized controlled design with a total of 68 participants in the experimental (n=35) and control (n=33) groups. The participants in the experimental group received the SVVR training program and their counterparts in the control group did not receive any training.
RESULTS


Generalized estimating equation analyses indicated that the experimental group showed significant posttraining improvements in problem-solving and self-efficacy but not teamwork when compared with the control group.
CONCLUSIONS


The results of this study revealed that SVVR could improve participants' problem-solving skills and self-efficacy for assisting students in not using illegal drugs. However, future studies are suggested to develop effective SVVR to assist inexperienced volunteers in enhancing their teamwork abilities. We believed that introducing the training program to more sites can enhance volunteer training so that volunteers can have a better companionship effect when helping students quit drugs.
TRIAL REGISTRATION


ClinicalTrials.gov NCT05072431; https://clinicaltrials.gov/ct2/show/NCT05072431.",2021,"RESULTS


Generalized estimating equation analyses indicated that the experimental group showed significant posttraining improvements in problem-solving and self-efficacy but not teamwork when compared with the control group.
","[""volunteers' abilities to assist students using drugs"", '68 participants in the experimental (n=35) and control (n=33) groups', 'inexperienced volunteers who help with drug use prevention', 'students who experiment with drugs from reusing them', 'volunteers who helped prevent adolescents from using illegal drugs']","['spherical video-based virtual reality (SVVR) training', '3D Virtual Reality Training', 'SVVR', 'animation or 3D virtual reality (VR', 'SVVR training program and their counterparts in the control group did not receive any training']","[""participants' problem-solving skills and self-efficacy"", 'problem-solving, self-efficacy, and teamwork', 'Problem-solving, Self-efficacy, and Teamwork', 'problem-solving and self-efficacy']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}]","[{'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0376650', 'cui_str': 'Animation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",68.0,0.0230125,"RESULTS


Generalized estimating equation analyses indicated that the experimental group showed significant posttraining improvements in problem-solving and self-efficacy but not teamwork when compared with the control group.
","[{'ForeName': 'Chih-Huei', 'Initials': 'CH', 'LastName': 'Chiang', 'Affiliation': 'Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Chiu-Mieh', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Institute of Clinical Nursing, College of Nursing, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Jiunn-Jye', 'Initials': 'JJ', 'LastName': 'Sheu', 'Affiliation': 'School of Population, Health University of Toledo, Toledo, OH, United States.'}, {'ForeName': 'Jung-Yu', 'Initials': 'JY', 'LastName': 'Liao', 'Affiliation': 'Department of Public Health, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Hsiao-Pei', 'Initials': 'HP', 'LastName': 'Hsu', 'Affiliation': 'Department of Nursing, College of Nursing, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Wen', 'Initials': 'SW', 'LastName': 'Wang', 'Affiliation': 'Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Jong-Long', 'Initials': 'JL', 'LastName': 'Guo', 'Affiliation': 'Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, Taipei, Taiwan.'}]",Journal of medical Internet research,['10.2196/29862']
2121,34731769,"Effect of treatment adherence training given to patients with bipolar disorder on treatment adherence, social functioning and quality of life: A pilot study.","BACKGROUND


and purpose: Treatment non-adherence is quite common among patients with bipolar disorder, negatively affects the social functioning of patients and reduces the quality of life. This pilot study aims to measure the effect of treatment adherence training given to patients with bipolar disorder on treatment adherence, social functioning and quality of life.
MATERIALS AND METHODS


The pilot study was conducted with 40 bipolar disorder patients, 19 in the intervention group and 21 in the control group, using a quasi-experimental research design. The data were collected using the Participant Information Form, Medication Adherence Rating Scale, Social Functioning Scale and Short Form of the World Health Organization Quality of Life Questionnaire. Treatment adherence training was given once a week individually for a total of five sessions.
RESULTS


There was no significant difference between the demographic characteristics and pre-test scale scores of the patients in the intervention and control groups before the treatment adherence training (p > 0.05). The mean treatment adherence, social functioning and quality of life scores of the patients in the intervention group were higher in the post-test and follow-up test compared to the patients in the control group (p < 0.001).
CONCLUSION


The intervention had a positive effect on treatment adherence, social functioning and quality of life of patients. Considering the promising results of this pilot study, treatment adherence training should be studied further in the patients with biplor disorder.",2021,"The mean treatment adherence, social functioning and quality of life scores of the patients in the intervention group were higher in the post-test and follow-up test compared to the patients in the control group (p < 0.001).
","['patients with biplor disorder', 'patients with bipolar disorder on treatment adherence, social functioning and quality of life', 'patients with bipolar disorder', '40 bipolar disorder patients, 19 in the intervention group and 21 in the control group, using a quasi-experimental research design']",['adherence training'],"['mean treatment adherence, social functioning and quality of life scores', 'quality of life', 'treatment adherence, social functioning and quality of life of patients', 'demographic characteristics and pre-test scale scores', 'Medication Adherence Rating Scale, Social Functioning Scale and Short Form of the World Health Organization Quality of Life Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C2585826', 'cui_str': 'Social functioning scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.00504294,"The mean treatment adherence, social functioning and quality of life scores of the patients in the intervention group were higher in the post-test and follow-up test compared to the patients in the control group (p < 0.001).
","[{'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Başkaya', 'Affiliation': 'University of Uşak, Vocational School of Health Services, Department of Health Care Services, Uşak, 64300, Turkey. Electronic address: ebru.kurdal@usak.edu.tr.'}, {'ForeName': 'Satı', 'Initials': 'S', 'LastName': 'Demir', 'Affiliation': 'University of Gazi, Faculty of Health Sciences, Departman of Psychiatric Nursing, Ankara, 06000, Turkey. Electronic address: satiunal@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101504']
2122,34686815,The ADEPT study: a comparative study of dentists' ability to detect enamel-only proximal caries in bitewing radiographs with and without the use of AssistDent artificial intelligence software.,"Introduction Reversal of enamel-only proximal caries by non-invasive treatments is important in preventive dentistry. However, detecting such caries using bitewing radiography is difficult and the subtle patterns are often missed by dental practitioners.Aims To investigate whether the ability of dentists to detect enamel-only proximal caries is enhanced by the use of AssistDent artificial intelligence (AI) software.Materials and methods In the ADEPT (AssistDent Enamel-only Proximal caries assessmenT) study, 23 dentists were randomly divided into a control arm, without AI assistance, and an experimental arm, in which AI assistance provided on-screen prompts indicating potential enamel-only proximal caries. All participants analysed a set of 24 bitewings in which an expert panel had previously identified 65 enamel-only carious lesions and 241 healthy proximal surfaces.Results The control group found 44.3% of the caries, whereas the experimental group found 75.8%. The experimental group incorrectly identified caries in 14.6% of the healthy surfaces compared to 3.7% in the control group. The increase in sensitivity of 71% and decrease in specificity of 11% are statistically significant (p <0.01).Conclusions AssistDent AI software significantly improves dentists' ability to detect enamel-only proximal caries and could be considered as a tool to support preventive dentistry in general practice.",2021,The increase in sensitivity of 71% and decrease in specificity of 11% are statistically significant (p <0.01).Conclusions,"['All participants analysed a set of 24 bitewings in which an expert panel had previously identified 65 enamel-only carious lesions and 241 healthy proximal surfaces', '23 dentists']","['control arm, without AI assistance, and an experimental arm, in which AI assistance provided on-screen prompts indicating potential enamel-only proximal caries']","['sensitivity', 'specificity']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",23.0,0.027699,The increase in sensitivity of 71% and decrease in specificity of 11% are statistically significant (p <0.01).Conclusions,"[{'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Devlin', 'Affiliation': 'Professor of Restorative Dentistry, Division of Dentistry, School of Medical Sciences, University of Manchester, UK; Director, Manchester Imaging Ltd, UK.'}, {'ForeName': 'Tomos', 'Initials': 'T', 'LastName': 'Williams', 'Affiliation': 'Honorary Research Assistant, Division of Dentistry, School of Medical Sciences, University of Manchester, UK; Software Manager, Manchester Imaging Ltd, UK. tomos.williams@manchester.ac.uk.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'Director, Manchester Imaging Ltd, UK; Honorary Reader, Division of Informatics, Imaging and Data Sciences, School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ashley', 'Affiliation': 'Consultant and MAHSC Honorary Professor in Restorative Dentistry and Oral Health, University Dental Hospital of Manchester, Manchester University NHS Foundation Trust, UK.'}]",British dental journal,['10.1038/s41415-021-3526-6']
2123,34656225,"Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis.","BACKGROUND


Cyclin-dependent kinase 4/6 inhibitors (CDKIs) are oral targeted agents approved for use in combination with endocrine therapy as first-line or second-line treatment of patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer. We previously reported the pooled analyses of progression-free survival in patients in specific clinicopathological subgroups, all of whom received consistent benefit from the addition of a CDKI to hormonal therapy. Here, we report the pooled overall survival results in patients treated with a CDKI and fulvestrant.
METHODS


In this exploratory analysis, we pooled individual patient data from three phase 3 randomised trials of CDKI or placebo in combination with fulvestrant in patients with breast cancer submitted to the US Food and Drug Administration and approved before Aug 1, 2020, in support of marketing applications. All analysed patients were aged at least 18 years, had an Eastern Cooperative Oncology Group performance status of 0-1, had hormone receptor-positive, HER2-negative advanced or metastatic breast cancer, and received at least one dose of CDKI or placebo in combination with fulvestrant. The median overall survival was estimated using Kaplan-Meier methods, and hazard ratios (HRs) with corresponding 95% CIs were estimated using Cox regression models. Patients were analysed collectively, by number of previous lines of systemic endocrine therapy in any disease setting (first-line or endocrine naive vs second-line and later), and in various clinicopathological subgroups of interest. The estimated median overall survival was not reported by group when the pooled population included patients treated across lines of therapy because of potential patient heterogeneity. All results presented are considered exploratory and hypothesis generating.
FINDINGS


Across the three pooled trials, 1960 patients were randomly assigned between Oct 7, 2013, and June 10, 2016 (12 patients were not treated and 1296 [66%] patients were randomly assigned to CDKI and 652 [33%] to placebo). In all treated patients (n=1948), the estimated HR for overall survival was 0·77 (95% CI 0·68-0·88), with a median follow-up of 43·7 months (IQR 37·8-47·7) and deaths in 935 (48%) of the 1948 patients. The difference in estimated median overall survival was 7·1 months, favouring CDKIs. In patients who received CDKIs or placebo in combination with fulvestrant as first-line systemic endocrine therapy (two trials; n=396), the estimated HR for overall survival was 0·74 (95% CI 0·52-1·07), with a median follow-up of 39·4 months (IQR 37·0-42·2). 123 (31%) of these patients died. The difference in estimated median overall survival could not be calculated because median overall survival was not estimable (95% CI 50·9-not estimable) in the CDKI group and was 45·7 months (95% CI 41·7-not estimable) in the placebo group. In patients who received CDKIs or placebo in combination with fulvestrant as second-line or later systemic endocrine therapy (three trials; n=1552), the estimated HR for overall survival was 0·77 (95% CI 0·67-0·89), with a median follow-up of 45·1 months (95% CI 39·2-48·5). 812 (52%) of these patients died. The difference in estimated median overall survival was 7·0 months, favouring CDKIs.
INTERPRETATION


The addition of CDKIs to fulvestrant resulted in a consistent overall survival benefit in all pooled patients and within most clinicopathological subgroups of interest. These findings support the existing standard of care of CDKIs plus fulvestrant for the treatment of patients with hormone receptor-positive, HER2-negative, advanced breast cancer.
FUNDING


None.",2021,The difference in estimated median overall survival could not be calculated because median overall survival was not estimable (95% CI 50·9-not estimable) in the CDKI group and was 45·7 months (95% CI 41·7-not estimable) in the placebo group.,"['patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer', 'All analysed patients were aged at least 18 years, had an Eastern Cooperative Oncology Group performance status of 0-1, had hormone receptor-positive, HER2-negative advanced or metastatic breast cancer, and received at least one dose of', 'patients treated with a CDKI and fulvestrant', 'patients with hormone receptor-positive, HER2-negative, advanced breast cancer', '1960 patients were randomly assigned between Oct 7, 2013, and June 10, 2016 (12 patients were not treated and 1296', 'patients with breast cancer submitted to the US Food and Drug Administration and approved before Aug 1, 2020, in support of marketing applications', 'Patients were analysed collectively, by number of previous lines of systemic endocrine therapy in any disease setting (first-line or endocrine naive vs second-line and later), and in various clinicopathological subgroups of interest', 'patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a']","['cyclin-dependent kinase 4/6 inhibitor plus fulvestrant', 'fulvestrant', 'CDKIs plus fulvestrant', 'CDKI or placebo in combination with fulvestrant', 'CDKI or placebo', 'CDKIs or placebo in combination with fulvestrant', 'CDKIs or placebo', 'placebo']","['Overall survival', 'median overall survival', 'overall survival benefit', 'overall survival', 'estimated median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1310510', 'cui_str': 'POU3F2 protein, human'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]","[{'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",12.0,0.739993,The difference in estimated median overall survival could not be calculated because median overall survival was not estimable (95% CI 50·9-not estimable) in the CDKI group and was 45·7 months (95% CI 41·7-not estimable) in the placebo group.,"[{'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gao', 'Affiliation': 'Oncology Center of Excellence, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: jennifer.gao@fda.hhs.gov.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Tatiana M', 'Initials': 'TM', 'LastName': 'Prowell', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bloomquist', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Suparna B', 'Initials': 'SB', 'LastName': 'Wedam', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Royce', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Krol', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Osgood', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Gwynn', 'Initials': 'G', 'LastName': 'Ison', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'Oncology Center of Excellence, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Oncology Center of Excellence, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Oncology Center of Excellence, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00472-1']
2124,34656656,Artificial intelligence for caries detection: Randomized trial.,"OBJECTIVES


We aimed to assess the impact of an artificial intelligence (AI)-based diagnostic-support software for proximal caries detection on bitewing radiographs.
METHODS


A cluster-randomized cross-over controlled trial was conducted. A commercially available software employing a fully convolutional neural network for caries detection (dentalXrai Pro, dentalXrai Ltd.) was randomly employed by 22 dentists, supporting their caries detection on 20 bitewings randomly chosen from a pool of 140 bitewings, with 10 bitewings randomly being supported by AI and 10 not. The reference test had been established by 4 + 1 independent experts in a pixelwise fashion. Caries was subgrouped as enamel, early dentin and advanced dentin caries, and accuracy and treatment decisions for each caries lesion assessed.
RESULTS


Dentists with AI showed a significantly higher mean (95% CI) area under the Receiver-Operating-Characteristics curve (0.89; 0.87-0.90) than those without AI (0.85; 0.83-0.86; p<0.05), mainly as their sensitivity was significantly higher (0.81; 0.74-0.87 compared with 0.72; 0.64-0.79; p<0.05) while the specificity was not significantly affected (p>0.05). This increase in sensitivity was found for enamel, but not early or advanced dentin lesions. Higher sensitivity came with an increase in non-invasive, but also invasive treatment decisions (p<0.05).
CONCLUSION


AI can increase dentists' diagnostic accuracy but may also increase invasive treatment decisions.
CLINICAL SIGNIFICANCE


AI can increase dentists' diagnostic accuracy, mainly via increasing their sensitivity for detecting enamel lesions, but may also increase invasive therapy decisions. Differences in the effects of AI for different dentists should be explored, and dentists should be guided as to which therapy to choose when detecting caries lesions using AI support.",2021,"Higher sensitivity came with an increase in non-invasive, but also invasive treatment decisions (p<0.05).
",[],['artificial intelligence (AI)-based diagnostic-support software'],"['sensitivity', ""dentists' diagnostic accuracy""]",[],"[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0749111,"Higher sensitivity came with an increase in non-invasive, but also invasive treatment decisions (p<0.05).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mertens', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany; Department of Operative and Preventive Dentistry, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Krois', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Anselmo Garcia', 'Initials': 'AG', 'LastName': 'Cantu', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Lubaina T', 'Initials': 'LT', 'LastName': 'Arsiwala', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Schwendicke', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany. Electronic address: falk.schwendicke@charite.de.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103849']
2125,34730541,Adherence With Online Therapy vs Face-to-Face Therapy and With Online Therapy vs Care as Usual: Secondary Analysis of Two Randomized Controlled Trials.,"BACKGROUND


Adherence to internet-delivered interventions targeting mental health such as online psychotherapeutic aftercare is important for the intervention's impact. High dropout rates limit the impact and generalizability of findings. Baseline differences may be putting patients at risk for dropping out, making comparisons between online with face-to-face (F2F) therapy and care as usual (CAU) necessary to examine.
OBJECTIVE


This study investigated adherence to online, F2F, and CAU interventions as well as study dropout among these groups and the subjective evaluation of the therapeutic relationship. Sociodemographic, social-cognitive, and health-related variables were considered.
METHODS


In a randomized controlled trial, 6023 patients were recruited, and 300 completed the baseline measures (T1), 144 completed T2 (retention 44%-52%), and 95 completed T3 (retention 24%-36%). Sociodemographic variables (eg, age, gender, marital status, educational level), social-cognitive determinants (eg, self-efficacy, social support), health-related variables (eg, depressiveness), and expectation towards the treatment for patients assigned to online or F2F were measured at T1.
RESULTS


There were no significant differences between the groups regarding dropout rates (χ 2 1 =0.02-1.06, P≥.30). Regarding adherence to the treatment condition, the online group outperformed the F2F and CAU conditions (P≤.01), indicating that patients randomized into the F2F and CAU control groups were much more likely to show nonadherent behavior in comparison with the online therapy groups. Within study groups, gender differences were significant only in the CAU group at T2, with women being more likely to drop out. At T3, age and marital status were also only significant in the CAU group. Patients in the online therapy group were significantly more satisfied with their treatment than patients in the F2F group (P=.02; Eta²=.09). Relationship satisfaction and success satisfaction were equally high (P>.30; Eta²=.02). Combining all study groups, patients who reported lower depressiveness scores at T1 (T2: odds ratio [OR] 0.55, 95% CI 0.35-0.87; T3: OR 0.56, 95% CI 0.37-0.92) were more likely to be retained, and patients who had higher self-efficacy (T2: OR 0.57, 95% CI 0.37-0.89; T3: OR 0.52, 95% CI 0.32-0.85) were more likely to drop out at T2 and T3. Additionally, at T3, the lower social support that patients reported was related to a higher likelihood of remaining in the study (OR 0.68, 95% CI 0.48-0.96). Comparing the 3 intervention groups, positive expectation was significantly related with questionnaire completion at T2 and T3 after controlling for other variables (T2: OR 1.64, 95% CI 1.08-2.50; T3: OR 1.59, 95% CI 1.01-2.51).
CONCLUSIONS


While online interventions have many advantages over F2F variants such as saving time and effort to commute to F2F therapy, they also create difficulties for therapists and hinder their ability to adequately react to patients' challenges. Accordingly, patient characteristics that might put them at risk for dropping out or not adhering to the treatment plan should be considered in future research and practice. Online aftercare, as described in this research, should be provided more often to medical rehabilitation patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04989842; https://clinicaltrials.gov/ct2/show/NCT04989842.",2021,"There were no significant differences between the groups regarding dropout rates (χ 2 1 =0.02-1.06, P≥.30).","['6023 patients were recruited, and 300 completed the baseline measures (T1), 144 completed T2 (retention 44%-52%), and 95 completed T3 (retention 24%-36']","['CAU', 'Online Therapy vs Face-to-Face Therapy and With Online Therapy']","['Relationship satisfaction and success satisfaction', 'questionnaire completion', 'positive expectation', 'dropout rates', 'Sociodemographic variables (eg, age, gender, marital status, educational level), social-cognitive determinants (eg, self-efficacy, social support), health-related variables (eg, depressiveness), and expectation', 'Sociodemographic, social-cognitive, and health-related variables']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",6023.0,0.111764,"There were no significant differences between the groups regarding dropout rates (χ 2 1 =0.02-1.06, P≥.30).","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Lippke', 'Affiliation': 'Department of Psychology and Methods, Jacobs University Bremen, Bremen, Germany.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Psychology and Methods, Jacobs University Bremen, Bremen, Germany.'}, {'ForeName': 'Franziska Maria', 'Initials': 'FM', 'LastName': 'Keller', 'Affiliation': 'Department of Psychology and Methods, Jacobs University Bremen, Bremen, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Becker', 'Affiliation': 'Dr. Becker Klinikgruppe, Cologne, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Dahmen', 'Affiliation': 'Dr. Becker Klinikgruppe, Cologne, Germany.'}]",Journal of medical Internet research,['10.2196/31274']
2126,34728529,Relationships of Changes in Physical Activity and Sedentary Behavior With Changes in Physical Fitness and Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes: The Italian Diabetes and Exercise Study 2 (IDES_2).,"OBJECTIVE


In the Italian Diabetes and Exercise Study_2 (IDES_2), behavioral counseling promoted a sustained increase in physical activity (PA) volume (+3.3 MET h ⋅ week -1 ), moderate- to vigorous-intensity PA (MVPA) (+6.4 min ⋅ day -1 ), and light-intensity PA (LPA) (+0.8 h ⋅ day -1 ) and decrease in sedentary time (SED-time) (-0.8 h ⋅ day -1 ). Here, we investigated the relationships of changes in PA/SED-time with changes in physical fitness and cardiometabolic risk profile in individuals with type 2 diabetes.
RESEARCH DESIGN AND METHODS


In this 3-year randomized clinical trial, 300 physically inactive and sedentary patients were randomized 1:1 to receive 1-month theoretical and practical counseling once a year or standard care. Changes in physical fitness and cardiovascular risk factors/scores according to quartiles of accelerometer-measured changes in PA/SED-time were assessed, together with univariate and multivariable associations between these parameters, in the whole cohort and by study arm.
RESULTS


Physical fitness increased and HbA 1c  and coronary heart disease 10-year risk scores decreased with quartiles of MVPA and SED-time change. In quartile IV of MVPA increase and SED-time decrease, cardiorespiratory fitness increased by 5.23 and 4.49 mL ⋅ min -1  ⋅ kg -1  and HbA 1c  decreased by 0.73 and 0.85%, respectively. Univariate correlations confirmed these relationships, and mean changes in both MPVA and SED-time predicted changes in physical fitness and cardiovascular risk factors/scores independently of one another and of other confounders. Similar findings were observed with LPA and PA volume and in each group separately.
CONCLUSIONS


Even modest increments in MVPA may have a clinically meaningful impact, and reallocating SED-time to LPA may also contribute to improved outcomes, possibly by increasing total energy expenditure.",2021,"RESULTS


Physical fitness increased and HbA 1c  and coronary heart disease 10-year risk scores decreased with quartiles of MVPA and SED-time change.","['Individuals With Type 2 Diabetes', '300 physically inactive and sedentary patients', 'individuals with type 2 diabetes']",['1-month theoretical and practical counseling once a year or standard care'],"['Physical Fitness and Cardiometabolic Risk Profile', 'MVPA increase and SED-time decrease, cardiorespiratory fitness', 'LPA and PA volume', 'physical activity (PA) volume', 'physical fitness and cardiometabolic risk profile', 'Physical fitness increased and HbA 1c  and coronary heart disease 10-year risk scores', 'sedentary time (SED-time', 'physical fitness and cardiovascular risk factors/scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1096202', 'cui_str': 'Lipoprotein (a) measurement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",300.0,0.0223833,"RESULTS


Physical fitness increased and HbA 1c  and coronary heart disease 10-year risk scores decreased with quartiles of MVPA and SED-time change.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Balducci', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Rome, Italy.'}, {'ForeName': 'Jonida', 'Initials': 'J', 'LastName': 'Haxhi', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Sacchetti', 'Affiliation': 'Department of Human Movement and Sport Sciences, University of Rome ""Foro Italico,"" Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Orlando', 'Affiliation': 'Department of Human Movement and Sport Sciences, University of Rome ""Foro Italico,"" Rome, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Cardelli', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Rome, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Rome, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Mattia', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Rome, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Iacobini', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Rome, Italy.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Bollanti', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Conti', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Rome, Italy.'}, {'ForeName': 'Silvano', 'Initials': 'S', 'LastName': 'Zanuso', 'Affiliation': 'Center for Applied Biological and Exercise Sciences, Faculty of Health and Life Sciences, Coventry University, Coventry, U.K.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nicolucci', 'Affiliation': 'Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pugliese', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc21-1505']
2127,34728525,A Phase 2 Study of the Efficacy and Safety of Oral Selinexor in Recurrent Glioblastoma.,"PURPOSE


Selinexor is an oral selective inhibitor of exportin-1 (XPO1) with efficacy in various solid and hematological tumors. We assessed intra-tumoral penetration, safety, and efficacy of selinexor monotherapy for recurrent glioblastoma.
PATIENTS AND METHODS


Seventy-six adults with Karnofsky Performance Status{greater than or equal to}60 were enrolled. Patients undergoing cytoreductive surgery received up to three selinexor doses (twice weekly) pre-operatively (Arm A; N=8 patients). Patients not undergoing surgery received 50mg/m 2  (Arm B, N=24), or 60mg (Arm C, N=14) twice weekly, or 80mg once weekly (Arm D; N=30). Primary endpoint was six-month progression-free survival rate (PFS6).
RESULTS


Median selinexor concentrations in resected tumors from patients receiving pre-surgical selinexor was 105.4nM (range 39.7-291nM). In Arms B, C, and D, respectively, the PFS6 was 10% (95%CI, 2.79-35.9), 7.7% (95%CI, 1.17-50.6), and 17% (95%CI, 7.78-38.3). Measurable reduction in tumor size was observed in 19 (28%) and RANO-response rate overall was 8.8% (Arm B, 8.3% (95%CI, 1.0-27.0); C:7.7% (95%CI, 0.2-36.0); D:10% (95%CI, 2.1-26.5)), with one complete and two durable partial responses in Arm D. Serious adverse events (AEs) occurred in 26 (34%) patients; one (1.3%) was fatal. The most common treatment-related AEs were fatigue (61%), nausea (59%), decreased appetite (43%) and thrombocytopenia (43%), and were manageable by supportive care and dose modification. Molecular studies identified a signature predictive of response (AUC=0.88).
CONCLUSION


At 80mg weekly, single-agent selinexor induced responses and clinically relevant PFS6 with manageable side effects requiring dose reductions. Ongoing trials are evaluating safety and efficacy of selinexor in combination with other therapies for newly diagnosed or recurrent glioblastoma.",2021,Serious adverse events (AEs) occurred in 26 (34%) patients; one (1.3%) was fatal.,"['newly diagnosed or recurrent glioblastoma', 'Seventy-six adults with Karnofsky Performance Status{greater than or equal to}60 were enrolled', 'Recurrent Glioblastoma', 'Patients undergoing cytoreductive surgery']","['selinexor monotherapy', 'Oral Selinexor', 'selinexor']","['thrombocytopenia', 'Serious adverse events (AEs', 'intra-tumoral penetration, safety, and efficacy', 'six-month progression-free survival rate (PFS6', 'decreased appetite', 'nausea', 'Median selinexor concentrations', 'Measurable reduction in tumor size', 'RANO-response rate overall']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}]","[{'cui': 'C3852671', 'cui_str': 'Selinexor'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3852671', 'cui_str': 'Selinexor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",76.0,0.250085,Serious adverse events (AEs) occurred in 26 (34%) patients; one (1.3%) was fatal.,"[{'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Lassman', 'Affiliation': 'Department of Neurology and Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center ABL7@cumc.columbia.edu.'}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Center For Neuro-Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Department of Neurology, Erasmus MC Cancer Institute.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Plotkin', 'Affiliation': 'Neurology and Cancer Center, Massachusetts General Hospital and Harvard Medical School.'}, {'ForeName': 'Annemiek M E', 'Initials': 'AME', 'LastName': 'Walenkamp', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen.'}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Green', 'Affiliation': 'Pediatric Hematology-Oncology-BMT, Morgan Adams Foundation Pediatric Brain Tumor Research Program, University of Colorado School of Medicine.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Karyopharm Therapeutics, Inc.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Walker', 'Affiliation': 'Karyopharm Therapeutics, Inc.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Karyopharm Therapeutics Inc.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Tamir', 'Affiliation': 'Product Leader Neuro-oncology, Karyopharm Therapeutics, Inc.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Henegar', 'Affiliation': 'Biology, Karyopharm Therapeutics Inc.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'DarwinHealth, Inc.'}, {'ForeName': 'Mariano J', 'Initials': 'MJ', 'LastName': 'Alvarez', 'Affiliation': 'Joint Centers for Systems Biology, Columbia University.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Califano', 'Affiliation': 'Department of Systems Biology, Columbia University.'}, {'ForeName': 'Yosef', 'Initials': 'Y', 'LastName': 'Landesman', 'Affiliation': 'Research & Translational Development, Karyopharm Therapeutics Inc.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Kauffman', 'Affiliation': 'Karyopharm Therapeutics (United States).'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Sacham', 'Affiliation': 'Karyopharm Therapeutics Inc.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Mau-Sørensen', 'Affiliation': 'Department of Oncology, Copehagen University Hospital, Rigshospitalet.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-2225']
2128,34687964,Transcranial direct current stimulation combined with alcohol cue inhibitory control training reduces the risk of early alcohol relapse: A randomized placebo-controlled clinical trial.,"BACKGROUND


Approximately half of all people with alcohol use disorder (AUD) relapse into alcohol reuse in the next few weeks after a withdrawal treatment. Brain stimulation and cognitive training represent recent forms of complementary interventions in the context of AUD.
OBJECTIVE


To evaluate the clinical efficacy of five sessions of 2 mA bilateral transcranial direct current stimulation (tDCS) for 20 min over the dorsolateral prefrontal cortex (DLPFC) (left cathodal/right anodal) combined with alcohol cue inhibitory control training (ICT) as part of rehabilitation. The secondary outcomes were executive functioning (e.g. response inhibition) and craving intensity, two mechanisms strongly related to abstinence.
METHODS


A randomized clinical trial with patients (n = 125) with severe AUD at a withdrawal treatment unit. Each patient was randomly assigned to one of four conditions, in a 2 [verum vs. sham tDCS] x 2 [alcohol cue vs. neutral ICT] factorial design. The main outcome of treatment was the abstinence rate after two weeks or more (up to one year).
RESULTS


Verum tDCS improved the abstinence rate at the 2-week follow-up compared to the sham condition, independently of the training condition (79.7% [95% CI = 69.8-89.6] vs. 60.7% [95% CI = 48.3-73.1]; p = .02). A priori contrasts analyses revealed higher abstinence rates for the verum tDCS associated with alcohol cue ICT (86.1% [31/36; 95% CI = 74.6-97.6]) than for the other three conditions (64% [57/89; 95% CI = 54-74]). These positive clinical effects on abstinence did not persist beyond two weeks after the intervention. Neither the reduction of craving nor the improvement in executive control resulted specifically from prefrontal-tDCS and ICT.
CONCLUSIONS


AUD patients who received tDCS applied to DLPFC showed a significantly higher abstinence rate during the weeks following rehabilitation. When combined with alcohol specific ICT, brain stimulation may provide better clinical outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov number NCT03447054 https://clinicaltrials.gov/ct2/show/NCT03447054.",2021,"RESULTS


Verum tDCS improved the abstinence rate at the 2-week follow-up compared to the sham condition, independently of the training condition (79.7% [95% CI = 69.8-89.6] vs. 60.7% [95% CI = 48.3-73.1]; p = .02).",['patients (n\xa0=\xa0125) with severe AUD at a withdrawal treatment unit'],"['tDCS', 'Transcranial direct current stimulation combined with alcohol cue inhibitory control training', 'Brain stimulation and cognitive training', 'alcohol specific ICT, brain stimulation', '2\xa0mA bilateral transcranial direct current stimulation (tDCS', 'alcohol cue inhibitory control training (ICT', '2 [verum vs. sham tDCS] x 2 [alcohol cue vs. neutral ICT', 'placebo']","['abstinence rate', 'reduction of craving', 'executive functioning (e.g. response inhibition) and craving intensity, two mechanisms strongly related to abstinence', 'risk of early alcohol relapse', 'abstinence rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",125.0,0.292829,"RESULTS


Verum tDCS improved the abstinence rate at the 2-week follow-up compared to the sham condition, independently of the training condition (79.7% [95% CI = 69.8-89.6] vs. 60.7% [95% CI = 48.3-73.1]; p = .02).","[{'ForeName': 'Macha', 'Initials': 'M', 'LastName': 'Dubuson', 'Affiliation': ""Laboratoire de Psychologie Médicale et D'Addictologie, Faculty of Medicine, Université Libre de Bruxelles (ULB), Brussels, Belgium; ULB Neuroscience Institute (UNI), Belgium.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kornreich', 'Affiliation': ""Laboratoire de Psychologie Médicale et D'Addictologie, Faculty of Medicine, Université Libre de Bruxelles (ULB), Brussels, Belgium; ULB Neuroscience Institute (UNI), Belgium; CHU Brugmann, Psychiatry Institute, Brussels, Belgium; Faculty of Psychology, Université Libre de Bruxelles (ULB), Brussels, Belgium.""}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Head and Skin, Ghent University Hospital, Ghent University, Ghent, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Ghent University Hospital, Ghent University, Ghent, Belgium; Department of Psychiatry University Hospital (UZBrussel), Brussels, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Wyckmans', 'Affiliation': ""Laboratoire de Psychologie Médicale et D'Addictologie, Faculty of Medicine, Université Libre de Bruxelles (ULB), Brussels, Belgium; ULB Neuroscience Institute (UNI), Belgium.""}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Dousset', 'Affiliation': ""Laboratoire de Psychologie Médicale et D'Addictologie, Faculty of Medicine, Université Libre de Bruxelles (ULB), Brussels, Belgium; ULB Neuroscience Institute (UNI), Belgium.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hanak', 'Affiliation': 'CHU Brugmann, Psychiatry Institute, Brussels, Belgium.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Veeser', 'Affiliation': 'CHU Brugmann, Psychiatry Institute, Brussels, Belgium.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Campanella', 'Affiliation': ""Laboratoire de Psychologie Médicale et D'Addictologie, Faculty of Medicine, Université Libre de Bruxelles (ULB), Brussels, Belgium; ULB Neuroscience Institute (UNI), Belgium; Faculty of Psychology, Université Libre de Bruxelles (ULB), Brussels, Belgium.""}, {'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'Chatard', 'Affiliation': 'Faculty of Psychology, University of Poitiers, Poitiers, France.'}, {'ForeName': 'Nemat', 'Initials': 'N', 'LastName': 'Jaafari', 'Affiliation': 'Faculty of Medicine, University of Poitiers, Poitiers, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Noël', 'Affiliation': ""Laboratoire de Psychologie Médicale et D'Addictologie, Faculty of Medicine, Université Libre de Bruxelles (ULB), Brussels, Belgium; ULB Neuroscience Institute (UNI), Belgium; Faculty of Psychology, Université Libre de Bruxelles (ULB), Brussels, Belgium. Electronic address: Xavier.Noel@ulb.be.""}]",Brain stimulation,['10.1016/j.brs.2021.10.386']
2129,34734899,Transcranial Direct Current Stimulation and Yoga for Functional Movement Disorders.,"BACKGROUND


Functional movement disorder (FMD), a conversion disorder characterized by involuntary movements, is difficult to treat.
METHODS


We aimed to assess the effects of anodal transcranial direct current stimulation (tDCS) and yoga in FMD patients (n=5). TDCS of the right temporoparietal junction, a brain region relevant in the sense of self-agency, was conducted. Subjects underwent both sham and anodal tDCS with a washout period of 3 weeks. Yoga was used as a mode of exercise, as well as in conjunction with stimulation to sustain potential changes in neural plasticity.
RESULTS


A total of 5 subjects completed the study [mean age: 52 (SE: 4) y, disease duration: 5 (SE: 1.6) y], undergoing both sham and anodal tDCS. Anodal tDCS does not appear to be superior to sham tDCS in alleviating symptoms and disability, but combining tDCS and yoga appears to lead to mild improvement noted on clinical observation, based on the change in the efficacy index of Clinical Global Impression found in 4 subjects.
CONCLUSION


Our study results suggest that anodal tDCS is not superior to sham tDCS in alleviating subjective symptoms and disability in FMD. However, interpretation of these results is limited due to the small number of stimulation sessions and number of subjects. Future studies using more frequent stimulation sessions are needed to further determine whether anodal tDCS may have a therapeutic effect in this patient group compared with sham tDCS.",2021,Our study results suggest that anodal tDCS is not superior to sham tDCS in alleviating subjective symptoms and disability in FMD.,"['FMD patients (n=5', 'A total of 5 subjects completed the study [mean age: 52 (SE: 4)\u2009y, disease duration: 5 (SE: 1.6)\u2009y], undergoing both sham and anodal tDCS']","['anodal tDCS', 'anodal transcranial direct current stimulation (tDCS) and yoga', 'Transcranial Direct Current Stimulation and Yoga', 'Anodal tDCS', 'sham and anodal tDCS']",[],"[{'cui': 'C4273557', 'cui_str': 'Functional movement disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",[],5.0,0.0522042,Our study results suggest that anodal tDCS is not superior to sham tDCS in alleviating subjective symptoms and disability in FMD.,"[{'ForeName': 'Jung E', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Dongguk University Ilsan Hospital.'}, {'ForeName': 'Ji-Yi', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'the Department of Life Science, Dongguk University, Goyang, Republic of Korea.'}, {'ForeName': 'Su-Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'the Department of Life Science, Dongguk University, Goyang, Republic of Korea.'}]",The neurologist,['10.1097/NRL.0000000000000345']
2130,34728206,Monitors to improve indoor air carbon dioxide concentrations in the hospital: A randomized crossover trial.,"BACKGROUND


Ventilation has emerged as an important strategy to reduce indoor aerosol transmission of coronavirus disease 2019. Indoor air carbon dioxide (CO 2 ) concentrations are a surrogate measure of respiratory pathogen transmission risk.
OBJECTIVES


To determine whether CO 2  monitors are necessary and effective to improve ventilation in hospitals.
METHODS


A randomized, placebo (sham)-controlled, crossover, open label trial. Between February and May 2021, we placed CO 2  monitors in twelve double-bed patient rooms across two geriatric wards. Staff were instructed to open windows, increase the air exchange rate and reduce room crowding to maintain indoor air CO 2  concentrations ≤800 parts per million (ppm).
RESULTS


CO 2  levels increased during morning care and especially in rooms housing couples (rooming-in). The median (interquartile range, IQR) time/day with CO 2  concentration > 800 ppm (primary outcome) was 110 min (IQR 47-207) at baseline, 82 min (IQR 12-226.5) during sham periods, 78 min (IQR 20-154) during intervention periods and 140 min (IQR 19.5-612.5) post-intervention. The intervention period only differed significantly from the post-intervention period (P = 0.02), mainly due to an imbalance in rooming-in. Significant but small differences were observed in secondary outcomes of time/day with CO 2  concentrations > 1000 ppm and daily peak CO 2  concentrations during the intervention vs. baseline and vs. the post-intervention period, but not vs. sham. Staff reported cold discomfort for patients as the main barrier towards increasing ventilation.
DISCUSSION


Indoor air CO 2  concentrations in hospital rooms commonly peaked above recommended levels, especially during morning care and rooming-in. There are many possible barriers towards implementing CO 2  monitors to improve ventilation in a real-world hospital setting. A paradigm shift in hospital infection control towards adequate ventilation is warranted.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04770597.",2021,"The intervention period only differed significantly from the post-intervention period (P = 0.02), mainly due to an imbalance in rooming-in.",[],['placebo'],"['Indoor air carbon dioxide (CO 2 ) concentrations', 'indoor air carbon dioxide concentrations']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0428653', 'cui_str': 'Carbon dioxide concentration'}]",,0.194681,"The intervention period only differed significantly from the post-intervention period (P = 0.02), mainly due to an imbalance in rooming-in.","[{'ForeName': 'Michaël R', 'Initials': 'MR', 'LastName': 'Laurent', 'Affiliation': 'Geriatrics Department, Imelda Hospital, Bonheiden, Belgium; Geriatrics Department, University Hospitals Leuven, Leuven, Belgium. Electronic address: michael.laurent@imelda.be.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Frans', 'Affiliation': 'Department of Medical Microbiology, Imelda Hospital, Bonheiden, Belgium.'}]",The Science of the total environment,['10.1016/j.scitotenv.2021.151349']
2131,34724345,"Phase 1 clinical trial evaluating safety, exposure and pharmacodynamics of BTK inhibitor tolebrutinib (PRN2246, SAR442168).","Bruton's tyrosine kinase (BTK), expressed in B cells and cells of innate immunity, including microglia, is an essential signaling element downstream of the B-cell receptor and Fc-receptors. Tolebrutinib (PRN2246, SAR442168) is a potent BTK inhibitor that covalently binds the kinase, resulting in durable inhibition with the potential to target inflammation in the periphery and central nervous system (CNS). Tolebrutinib crosses the blood-brain barrier and potently inhibits BTK in microglial cells isolated from the CNS. A first-in-human randomized, double-blind, placebo-controlled study of tolebrutinib was conducted. The trial design consisted of five single ascending dose arms with oral administration of a single dose of 5, 15, 30, 60, and 120 mg (n = 6 per arm, n = 2 placebo), five multiple ascending dose arms with oral administration of 7.5, 15, 30, 60, and 90 mg (n = 8 per arm, n = 2 placebo) over 10 days, and one arm (n = 4) in which cerebral spinal fluid (CSF) exposure was measured 2 h after a single 120 mg dose. Tolebrutinib was well-tolerated in the study and all treatment-related treatment emergent adverse events were mild. Tolebrutinib was rapidly absorbed following oral administration with a rapid half-life of ~ 2 h. Peripheral BTK occupancy was assessed at various timepoints by an enzyme-linked immunosorbent assay-based readout using an irreversible probe. Assessments demonstrated extensive and prolonged peripheral BTK occupancy at steady-state with once daily doses as low as 7.5 mg. Further, CSF exposure was demonstrated 2 h after administration at 120 mg.",2021,Tolebrutinib was well tolerated in the study and all treatment-related treatment emergent adverse events (TEAEs) were mild.,[],"['5 Single Ascending Dose (SAD', 'placebo']","['extensive and prolonged peripheral BTK occupancy', 'tolerated']",[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0218158', 'cui_str': ""Bruton's Tyrosine Kinase""}]",,0.269529,Tolebrutinib was well tolerated in the study and all treatment-related treatment emergent adverse events (TEAEs) were mild.,"[{'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Owens', 'Affiliation': 'Principia Biopharma, a Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Patrick F', 'Initials': 'PF', 'LastName': 'Smith', 'Affiliation': 'Certara, Princeton, New Jersey, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Redfern', 'Affiliation': 'Linear Clinical Research, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'Principia Biopharma, a Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Shu', 'Affiliation': 'Principia Biopharma, a Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Dane E', 'Initials': 'DE', 'LastName': 'Karr', 'Affiliation': 'Principia Biopharma, a Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Hartmann', 'Affiliation': 'Certara, Princeton, New Jersey, USA.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Francesco', 'Affiliation': 'Principia Biopharma, a Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Langrish', 'Affiliation': 'Principia Biopharma, a Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Nunn', 'Affiliation': 'Principia Biopharma, a Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Gourlay', 'Affiliation': 'Principia Biopharma, a Sanofi Company, South San Francisco, California, USA.'}]",Clinical and translational science,['10.1111/cts.13162']
2132,34723892,Pelvic floor muscle training in mother fit healthcare centres: a best practice implementation project.,"INTRODUCTION AND AIMS


Pelvic floor dysfunctions are common complications during the childbirth process. Pelvic floor muscle training (PFMT) has been used as a conservative treatment in both prenatal and postnatal women. The aim of this project was to assess the compliance with evidence-based criteria regarding PFMT among prenatal and postnatal women in mother fit healthcare centres.
METHODS


The current study was performed in three phases. Phase 1: stakeholder engagement and team establishment and baseline audit. Phase 2: Design and implementation of strategies to improve PFMT among prenatal and postnatal women in mother fit healthcare centres. Phase 3: Follow-up audit. Baseline and follow-up audit with six yes/no audit questions was performed using the Joanna Briggs Institute Practical Application of Clinical Evidence System. Fifteen midwives involved in prenatal and postnatal healthcare centres and 60 pregnant women participated in this study.
RESULTS


The compliance for each audit criterion found in the baseline audit was low (0-7%). However, after implementation of the project and training the trainers (midwives), the compliance increased significantly (77-100%).
CONCLUSION


The current study demonstrated that we have some problems in the healthcare system to teach PFMT to pregnant women. We should also implement similar projects in all healthcare centres country wide. Healthcare system managers should be aware of the value of holding PFMT courses for pregnant women and it is recommended to use pelvic floor physiotherapists to train midwives.",2021,"However, after implementation of the project and training the trainers (midwives), the compliance increased significantly (77-100%).
","['mother fit healthcare centres', 'pregnant women', 'Fifteen midwives involved in prenatal and postnatal healthcare centres and 60 pregnant women participated in this study', 'prenatal and postnatal women in mother fit healthcare centres']","['Pelvic floor muscle training (PFMT', 'PFMT', 'Pelvic floor muscle training']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]",[],,0.0405799,"However, after implementation of the project and training the trainers (midwives), the compliance increased significantly (77-100%).
","[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Ghaderi', 'Affiliation': 'Research Center for Evidence-based Medicine, Iranian EBM Centre: A Joanna Briggs Institute (JBI) Centre of Excellence Department of Physiotherapy, Faculty of Rehabilitation Department of Urology, Faculty of Medicine Tabriz Health Centre, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Hajebrahimi', 'Affiliation': ''}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Ghaderi', 'Affiliation': ''}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Pashazadeh', 'Affiliation': ''}]",JBI evidence implementation,['10.1097/XEB.0000000000000296']
2133,34726874,Endoscopic Versus Microscopic Stapedotomy: A Single-Blinded Randomized Control Trial.,"OBJECTIVE


To demonstrate non-inferiority of endoscopic stapedotomy to microscopic stapedotomy for the treatment of otosclerosis.
STUDY DESIGN


Single-blinded randomized control trial.
SETTING


Tertiary, academic otology-neurotology practice.
PATIENTS


Adult subjects with a diagnosis of otosclerosis and a preoperative air-bone gap (ABG) more than or equal to 20 dB undergoing primary stapedotomy.
INTERVENTION


Endoscopic or microscopic stapedotomy.
MAIN OUTCOME MEASURES


Primary audiometric outcome was postoperative ABG. Secondary audiometric outcomes included speech reception threshold (SRT), word recognition score (WRS), bone- and air-conduction pure tone averages (PTA), change in ABG, and ABG closure rates to less than or equal to 10 dB and less than or equal to 20 dB.
RESULTS


Twenty-two patients were recruited. Eleven patients underwent endoscopic stapedotomy and 11 underwent microscopic stapedotomy. The endoscopic group was non-inferior to the microscopic group in terms of postoperative audiometric outcomes (endoscope versus microscope, p-value): ABG (8.1 dB versus 8.1 dB, <0.001), SRT (27.7 dB versus 25.9 dB, <0.001), WRS (92% at 65 dB versus 98% at 62 dB, <0.001), air-conduction PTA (33.5 dB versus 30.8 dB, <0.01), and change in ABG (23.0 dB versus 20.7 dB, <0.0001). ABG closure rates to less than or equal to 10 dB (72.7% versus 81.2%, p = 1.0) and less than or equal to 20 dB (90.9% versus 100%, p = 1.0) were not significantly different. There was no significant difference in operative time, necessity of scutum curettage, or postoperative dysgeusia. No patients required chorda tympani sacrifice. Preoperative tinnitus resolved in three patients in each group postoperatively.
CONCLUSIONS


This study is the first randomized control trial to demonstrate non-inferiority of endoscopic to microscopic stapedotomy.",2021,"There was no significant difference in operative time, necessity of scutum curettage, or postoperative dysgeusia.","['Patients\n\n\nAdult subjects with a diagnosis of otosclerosis and a preoperative air-bone gap (ABG) more than or equal to 20 dB undergoing primary stapedotomy', 'Results\n\n\nTwenty-two patients were recruited', 'Eleven patients underwent']","['endoscopic stapedotomy', 'microscopic stapedotomy', 'Endoscopic Versus Microscopic Stapedotomy', 'endoscopic stapedotomy to microscopic stapedotomy']","['speech reception threshold (SRT), word recognition score (WRS), bone- and air-conduction pure tone averages (PTA), change in ABG, and ABG closure rates', 'postoperative ABG', 'WRS', 'ABG closure rates', 'air-conduction PTA', 'chorda tympani sacrifice', 'Preoperative tinnitus', 'operative time, necessity of scutum curettage, or postoperative dysgeusia', 'postoperative audiometric outcomes', 'change in ABG', 'SRT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029899', 'cui_str': 'Otosclerosis'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0395740', 'cui_str': 'Small fenestra stapedectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0395740', 'cui_str': 'Small fenestra stapedectomy'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}]","[{'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0234744', 'cui_str': 'Air conduction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0008483', 'cui_str': 'Structure of chorda tympani'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",22.0,0.147485,"There was no significant difference in operative time, necessity of scutum curettage, or postoperative dysgeusia.","[{'ForeName': 'Caleb J', 'Initials': 'CJ', 'LastName': 'Fan', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Kaul', 'Affiliation': ''}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Mavrommatis', 'Affiliation': ''}, {'ForeName': 'Zachary G', 'Initials': 'ZG', 'LastName': 'Schwam', 'Affiliation': ''}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Derek K', 'Initials': 'DK', 'LastName': 'Kong', 'Affiliation': ''}, {'ForeName': 'Noel M', 'Initials': 'NM', 'LastName': 'Phan', 'Affiliation': ''}, {'ForeName': 'Dillan F', 'Initials': 'DF', 'LastName': 'Villavisanis', 'Affiliation': ''}, {'ForeName': 'Maura K', 'Initials': 'MK', 'LastName': 'Cosetti', 'Affiliation': ''}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Wanna', 'Affiliation': ''}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000003298']
2134,34715537,Student Acceptance of Virtual Bedside Surgical Tutorials During COVID-19; A Randomized Control Trial.,"BACKGROUND


The social distancing recommendations from the WHO during the pandemic has resulted in a pivot point in the delivery of medical education. With the medical student clinical experience constantly under threat; novel methods to maintain adequate surgical patient exposure and student interaction on a platform amenable to the interactive format required were devised using a virtual platform to compliment current pedagogical approaches.
METHODS


A parallel randomized control trial evaluated the perceived use of remote learning in place of bedside teaching. Participants were randomized to undergo surgical bedside teaching in person or virtually. Feedback questionnaires and exit interviews carried out following each session. Content analysis of transcripts was performed to evaluate the presence and quality of perceived learning, benefits and limitations to each modality.
RESULTS


Feedback demonstrated greater engagement, satisfaction, involvement and learning (P < 0.001) in the bedside teaching group. Content analysis yielded three main themes; Technological, Interpersonal Component, Provision of Content. Participants in the virtual group reported a limited ability to elicit clinically relevant findings in surgical patients. Students however reported the virtual teaching was an acceptable method of learning with 90% satisfaction reported for learning via the virtual platform.
DISCUSSION


The pandemic posed challenges to adequate student-patient exposure. Delivering surgical bedside teaching remotely is a method amenable to learning for students, with advantages including convenience, fewer reports of information fatigue, and decreased perceived pressure identified with this learning modality.",2021,"RESULTS


Feedback demonstrated greater engagement, satisfaction, involvement and learning (P < 0.001) in the bedside teaching group.",[],"['Virtual Bedside Surgical Tutorials', 'surgical bedside teaching in person or virtually', 'remote learning in place of bedside teaching']","['engagement, satisfaction, involvement and learning']",[],"[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.113077,"RESULTS


Feedback demonstrated greater engagement, satisfaction, involvement and learning (P < 0.001) in the bedside teaching group.","[{'ForeName': 'Aoife', 'Initials': 'A', 'LastName': 'Feeley', 'Affiliation': 'Midlands Regional Hospital Tullamore, Co. Offaly, Ireland; Royal College of Surgeons, Ireland; University College Dublin, Belfield, Ireland. Electronic address: 10308279@ucdconnect.ie.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Feeley', 'Affiliation': 'Midlands Regional Hospital Tullamore, Co. Offaly, Ireland; Royal College of Surgeons, Ireland; University College Dublin, Belfield, Ireland.'}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'Carroll', 'Affiliation': 'Midlands Regional Hospital Tullamore, Co. Offaly, Ireland; Royal College of Surgeons, Ireland; University College Dublin, Belfield, Ireland.'}, {'ForeName': 'Dermot J', 'Initials': 'DJ', 'LastName': 'Hehir', 'Affiliation': 'Midlands Regional Hospital Tullamore, Co. Offaly, Ireland; Royal College of Surgeons, Ireland; University College Dublin, Belfield, Ireland.'}]",The Journal of surgical research,['10.1016/j.jss.2021.09.029']
2135,34730535,"A Mobile App to Enhance Behavioral Activation Treatment for Substance Use Disorder: App Design, Use, and Integration Into Treatment in the Context of a Randomized Controlled Trial.","BACKGROUND


Group-based formats typically used in low-resource substance use disorder (SUD) treatment settings result in little individual attention to help reinforce and guide skill use, which may contribute to poor posttreatment outcomes. Smartphone apps offer a convenient, user-friendly, and cost-effective tool that can extend the reach of effective SUD treatments. A smartphone app was developed and integrated into a group-based, brief behavioral activation (BA) treatment for SUD to increase engagement in treatment skills outside clinician-administered sessions.
OBJECTIVE


This study aims to describe the features of the app and its use and integration into treatment, report the participants' self-reported feasibility and acceptability of the app, and discuss challenges and provide recommendations for future smartphone app integration into behavioral treatments for SUD.
METHODS


A total of 56 individuals recruited from intensive outpatient SUD treatment received a smartphone-enhanced BA treatment, the Life Enhancement Treatment for Substance Use. Self-reported weekly app use and reasons for nonuse were assessed at posttreatment and at 1- and 3-month follow-ups. In addition, 2-tailed t tests and chi-square tests compared the self-reported use of each app component and overall app use over time.
RESULTS


Participant feedback suggested that the integration of the smartphone app into the Life Enhancement Treatment for Substance Use was feasible and well accepted, and participants found the app useful for planning value-based activities outside of sessions. Self-reported app engagement decreased over the follow-up period: 72% (39/54) of participants reported using the app at posttreatment, decreasing to 69% (37/54) at the 1-month follow-up and 37% (20/54) at the 3-month follow-up. Participants reported forgetting to use the app as a primary reason for nonuse.
CONCLUSIONS


This study provides support for the feasibility and acceptability of smartphone-enhanced BA treatment, offering promise for future research testing the integration of technology into SUD treatment. Design decisions may help streamline smartphone integration into treatment, for example, allowing participants to download the treatment app on their own phones or use a low-cost study smartphone (or offering both options). Long-term app engagement may be increased via built-in reminders, alerts, and in-app messages.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02707887; https://clinicaltrials.gov/ct2/show/study/NCT02707887.",2021,"Self-reported app engagement decreased over the follow-up period: 72% (39/54) of participants reported using the app at posttreatment, decreasing to 69% (37/54) at the 1-month follow-up and 37% (20/54) at the 3-month follow-up.",['56 individuals recruited from intensive outpatient SUD treatment received a'],"['smartphone-enhanced BA treatment', 'smartphone-enhanced BA treatment, the Life Enhancement Treatment for Substance Use']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",[],56.0,0.0910747,"Self-reported app engagement decreased over the follow-up period: 72% (39/54) of participants reported using the app at posttreatment, decreasing to 69% (37/54) at the 1-month follow-up and 37% (20/54) at the 3-month follow-up.","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Paquette', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Dillon T', 'Initials': 'DT', 'LastName': 'Rubalcava', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Anand', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Stacey B', 'Initials': 'SB', 'LastName': 'Daughters', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}]",JMIR formative research,['10.2196/25749']
2136,34736011,Baseline apnea-hypopnea index threshold and adenotonsillectomy consideration in children with OSA.,"OBJECTIVES


Adenotonsillectomy (AT) is the first line of treatment for pediatric obstructive sleep apnea (OSA). In some treatment guidelines, children with moderate to severe OSA, defined as apnea-hypopnea index (AHI) ≥ 5, may be recommended AT regardless of symptoms. The differences in outcomes between children randomized to watchful waiting with supportive care (WWSC) or AT were compared based on baseline OSA severity threshold of AHI≥ 5.
METHODS


A secondary analysis of the Childhood Adenotonsillectomy Trial, a randomized controlled trial of children with OSA aged 5-9 years who underwent AT or WWSC, was performed. The primary outcome was the change in neurocognition measured by Developmental Neuropsychological Assessment (NEPSY). Secondary outcomes included changes in behavior, symptoms of OSA, and quality of life. Outcomes were measured at baseline and the seven-month follow-up after grouping children based on whether their AHI was greater than or equal to 5. Comparisons were performed using two-way analysis of covariance (ANCOVA) while controlling for age, sex and race. Differences in treatment effect were measured using Cohen's d.
RESULTS


Of the 397 children included, 203 received WWSC and 194 underwent AT. The treatment effects on post-randomization changes in neurocognition, measured by NEPSY in children with AHI ≥5 (Cohen's d = 0.1 [95% CI, -0.1 to 0.4]) was not significantly different from children with AHI <5 (Cohen's d = 0.1 [95% CI, -0.1 to 0.4]). Furthermore, among children in the AT group alone, the effects of AT on post-treatment changes in NEPSY did not differ based on AHI threshold (Cohen's d = -0.06 [95% CI, -0.3 to 0.2]). Additionally, the treatment effects on post-randomization changes in behavior, symptoms, and quality of life did not vary based on AHI threshold.
CONCLUSION


The outcomes of neurocognition, behavior, symptoms, and quality of life did not differ between children with OSA randomized to WWSC or AT based on OSA severity threshold alone. Additionally, the effects of AT on post-treatment outcomes did not differ based on AHI threshold.",2021,"The outcomes of neurocognition, behavior, symptoms, and quality of life did not differ between children with OSA randomized to WWSC or AT based on OSA severity threshold alone.","['children with OSA', 'children with AHI ≥5', 'pediatric obstructive sleep apnea (OSA', '397 children included, 203 received WWSC and 194 underwent AT', 'children with OSA aged 5-9 years who underwent AT or WWSC, was performed', 'children with moderate to severe OSA']","['WWSC', 'watchful waiting with supportive care (WWSC) or AT']","['neurocognition, behavior, symptoms, and quality of life', 'Baseline apnea-hypopnea index threshold and adenotonsillectomy consideration', 'behavior, symptoms, and quality of life', 'apnea-hypopnea index (AHI', 'change in neurocognition measured by Developmental Neuropsychological Assessment (NEPSY', 'changes in behavior, symptoms of OSA, and quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",397.0,0.0876344,"The outcomes of neurocognition, behavior, symptoms, and quality of life did not differ between children with OSA randomized to WWSC or AT based on OSA severity threshold alone.","[{'ForeName': 'Saikrishna C', 'Initials': 'SC', 'LastName': 'Gourishetti', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hamburger', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Pereira', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ron B', 'Initials': 'RB', 'LastName': 'Mitchell', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA; Department of Otolaryngology-Head and Neck Surgery, Children's Medical Center, Dallas, USA.""}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Isaiah', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: aisaiah@som.umaryland.edu.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2021.110959']
2137,34731553,Phase 3 Trial of mRNA-1273 during the Delta-Variant Surge.,,2021,,[],['mRNA-1273'],[],[],"[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]",[],,0.0913298,,"[{'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Hana M', 'Initials': 'HM', 'LastName': 'El Sahly', 'Affiliation': 'Baylor College of Medicine, Houston, TX hana.elsahly@bcm.edu.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Essink', 'Affiliation': 'Meridian Clinical Research, Omaha, NE.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Follmann', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'University of Maryland, Baltimore, MD.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'August', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Clouting', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Fortier', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Leav', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Talarico', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Girard', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Yamuna D', 'Initials': 'YD', 'LastName': 'Paila', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Tomassini', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schödel', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Pajon', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Honghong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Moderna, Cambridge, MA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Moderna, Cambridge, MA.'}]",The New England journal of medicine,['10.1056/NEJMc2115597']
2138,34689055,Amygdala electrical-finger-print (AmygEFP) NeuroFeedback guided by individually-tailored Trauma script for post-traumatic stress disorder: Proof-of-concept.,"BACKGROUND


Amygdala activity dysregulation plays a central role in post-traumatic stress disorder (PTSD). Hence learning to self-regulate one's amygdala activity may facilitate recovery. PTSD is further characterized by abnormal contextual processing related to the traumatic memory. Therefore, provoking the personal traumatic narrative while training amygdala down-regulation could enhance clinical efficacy. We report the results of a randomized controlled trial (NCT02544971) of a novel self-neuromodulation procedure (i.e. NeuroFeedback) for PTSD, aimed at down-regulating limbic activity while receiving feedback from an auditory script of a personal traumatic narrative. To scale-up applicability, neural activity was probed by an fMRI-informed EEG model of amygdala activity, termed Amygdala Electrical Finger-Print (AmygEFP).
METHODS


Fifty-nine adults meeting DSM-5 criteria for PTSD were randomized between three groups: Trauma-script feedback interface (Trauma-NF) or Neutral feedback interface (Neutral-NF), and a control group of No-NF (to control for spontaneous recovery). Before and immediately after 15 NF training sessions patients were blindly assessed for PTSD symptoms and underwent one session of amygdala fMRI-NF for transferability testing. Follow-up clinical assessment was performed at 3- and 6-months following NF treatment.
RESULTS


Patients in both NF groups learned to volitionally down-regulate AmygEFP signal and demonstrated a greater reduction in PTSD symptoms and improved down-regulation of the amygdala during fMRI-NF, compared to the No-NF group. The Trauma-NF group presented the largest immediate clinical improvement.
CONCLUSIONS


This proof-of-concept study indicates the feasibility of the AmygEFP-NF process-driven as a scalable intervention for PTSD and illustrates its clinical potential. Further investigation is warranted to elucidate the contribution of AmygEFP-NF beyond exposure and placebo effects.",2021,"RESULTS


Patients in both NF groups learned to volitionally down-regulate AmygEFP signal and demonstrated a greater reduction in PTSD symptoms and improved down-regulation of the amygdala during fMRI-NF, compared to the No-NF group.",['Fifty-nine adults meeting DSM-5 criteria for PTSD'],"['Trauma-script feedback interface (Trauma-NF) or Neutral feedback interface (Neutral-NF), and a control group of No-NF', 'novel self-neuromodulation procedure (i.e. NeuroFeedback', 'NeuroFeedback guided by individually-tailored Trauma script', 'Amygdala electrical-finger-print (AmygEFP']",['PTSD symptoms'],"[{'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",59.0,0.0413707,"RESULTS


Patients in both NF groups learned to volitionally down-regulate AmygEFP signal and demonstrated a greater reduction in PTSD symptoms and improved down-regulation of the amygdala during fMRI-NF, compared to the No-NF group.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Fruchtman-Steinbok', 'Affiliation': 'Sagol Brain Institute, Tel-Aviv Medical Center, Tel-Aviv, Israel; School of Psychological Sciences, Gershon H. Gordon Faculty of Social Sciences, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Jackob N', 'Initials': 'JN', 'LastName': 'Keynan', 'Affiliation': 'Sagol Brain Institute, Tel-Aviv Medical Center, Tel-Aviv, Israel; Department of Psychiatry & Behavioral Science, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Avihay', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Sagol Brain Institute, Tel-Aviv Medical Center, Tel-Aviv, Israel; School of Psychological Sciences, Gershon H. Gordon Faculty of Social Sciences, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Jaljuli', 'Affiliation': 'Department of Statistics and Operations Research, School of Mathematical Sciences, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Mermelstein', 'Affiliation': 'Sagol Brain Institute, Tel-Aviv Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Gadi', 'Initials': 'G', 'LastName': 'Drori', 'Affiliation': 'Sagol Brain Institute, Tel-Aviv Medical Center, Tel-Aviv, Israel; Sagol School of Neuroscience, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Routledge', 'Affiliation': 'Sagol Brain Institute, Tel-Aviv Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Krasnoshtein', 'Affiliation': 'Psychiatric Department, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playle', 'Affiliation': 'Center for Trials Research, College of Biomedical & Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David E J', 'Initials': 'DEJ', 'LastName': 'Linden', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Talma', 'Initials': 'T', 'LastName': 'Hendler', 'Affiliation': 'Sagol Brain Institute, Tel-Aviv Medical Center, Tel-Aviv, Israel; School of Psychological Sciences, Gershon H. Gordon Faculty of Social Sciences, Tel-Aviv University, Tel-Aviv, Israel; Sagol School of Neuroscience, Tel-Aviv University, Tel-Aviv, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: thendler@tauex.tau.ac.il.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2021.102859']
2139,34724860,A short-term non-randomized controlled study of ultrasound-guided microwave ablation and parathyroidectomy for secondary hyperparathyroidism.,"BACKGROUND


To compare the short-term clinical outcomes of ultrasound-guided microwave ablation (MWA) and parathyroidectomy (PTX) for severe secondary hyperparathyroidism(SHPT).
METHODS


In a prospective multi-center study, we compared the outcomes of MWA and PTX for severe SHPT. The outcome measures were case rate of successful treatment, improvement of clinical symptoms, incidence of complications, and differences in treatment parameters and costs between the two groups.
RESULTS


A total of 167 eligible patients were included in the study, of which 79 underwent MWA and 88 underwent PTX. There was no significant difference in rate of successful treatment between the MWA and PTX groups (χ 2 =2.299,  p  = 0.125). However, the MWA group showed significantly lower range of intact parathyroid hormone (iPTH) decrease than the PTX group ( t =-2.352,  p  = 0.023). Postoperative clinical symptoms improved in both groups, with no significant difference between the two groups ( p  > 0.05). Postoperative hypocalcemia was significantly more common in the PTX group ( p  < 0.05). The operative time, incision and postoperative pain of the MWA group were significantly better than those of the PTX group ( p  < 0.05), while postoperative recurrent laryngeal nerve injury and hematoma showed no significant difference between the two groups ( p  > 0.05). The cost of MWA was significantly less than PTX ( p  = 0.000).
CONCLUSIONS


Both MWA and PTX are effective and safe for severe secondary hyperparathyroidism. PTX is more thorough and traumatic, while MWA is minimally invasive and postoperative iPTH is more consistent with the Kidney Disease: Improving Global Outcomes (KDIGO) recommendation.",2021,"Postoperative clinical symptoms improved in both groups, with no significant difference between the two groups ( p  > 0.05).","['A total of 167 eligible patients were included in the study, of which 79 underwent MWA and 88 underwent PTX', 'secondary hyperparathyroidism']","['ultrasound-guided microwave ablation and parathyroidectomy', 'MWA and PTX', 'ultrasound-guided microwave ablation (MWA) and parathyroidectomy (PTX', 'MWA', 'PTX']","['postoperative recurrent laryngeal nerve injury and hematoma', 'Postoperative clinical symptoms', 'cost of MWA', 'operative time, incision and postoperative pain', 'range of intact parathyroid hormone (iPTH', 'case rate of successful treatment, improvement of clinical symptoms, incidence of complications', 'rate of successful treatment', 'Postoperative hypocalcemia']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2077203', 'cui_str': 'Recurrent Laryngeal Nerve Injury'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0047008', 'cui_str': ""3,4-O-isopropylidene-3,3',4,5'-tetrahydroxystilbene""}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}]",167.0,0.0547564,"Postoperative clinical symptoms improved in both groups, with no significant difference between the two groups ( p  > 0.05).","[{'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Ultrasound, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Linxue', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': 'Department of Ultrasound, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Teng', 'Affiliation': 'Department of Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mingan', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Ultrasound, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Fangyi', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Ultrasound, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Yujiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Ultrasound, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoqu', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Ultrasound, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}]","International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group",['10.1080/02656736.2021.1904153']
2140,34734839,Effect of Door-to-Door Screening and Awareness Generation Activities in the Catchment Areas of Vision Centers on Service Use: Protocol for a Randomized Experimental Study.,"BACKGROUND


A vision center (VC) is a significant eye care service model to strengthen primary eye care services. VCs have been set up at the block level, covering a population of 150,000-250,000 in rural areas in North India. Inadequate use by rural communities is a major challenge to sustainability of these VCs. This not only reduces the community's vision improvement potential but also impacts self-sustainability and limits expansion of services in rural areas. The current literature reports a lack of awareness regarding eye diseases and the need for care, social stigmas, low priority being given to eye problems, prevailing gender discrimination, cost, and dependence on caregivers as factors preventing the use of primary eye care.
OBJECTIVE


Our organization is planning an awareness-cum-engagement intervention-door-to-door basic eye checkup and visual acuity screening in VCs coverage areas-to connect with the community and improve the rational use of VCs.
METHODS


In this randomized, parallel-group experimental study, we will select 2 VCs each for the intervention arm and the control arm from among poor, low-performing VCs (ie, walk-in of ≤10 patients/day) in our 2 operational regions (Vrindavan, Mathura District, and Mohammadi, Kheri District) of Uttar Pradesh. Intervention will include door-to-door screening and awareness generation in 8-12 villages surrounding the VCs, and control VCs will follow existing practices of awareness generation through community activities and health talks. Data will be collected from each VC for 4 months of intervention. Primary outcomes will be an increase in the number of walk-in patients, spectacle advise and uptake, referral and uptake for cataract and specialty surgery, and operational expenses. Secondary outcomes will be uptake of refraction correction and referrals for cataract and other eye conditions. Differences in the number of walk-in patients, referrals, uptake of services, and cost involved will be analyzed.
RESULTS


Background work involved planning of interventions and selection of VCs has been completed. Participant recruitment has begun and is currently in progress.
CONCLUSIONS


Through this study, we will analyze whether our door-to-door intervention is effective in increasing the number of visits to a VC and, thus, overall sustainability. We will also study the cost-effectiveness of this intervention to recommend its scalability.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04800718; https://clinicaltrials.gov/ct2/show/NCT04800718.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/31951.",2021,"Primary outcomes will be an increase in the number of walk-in patients, spectacle advise and uptake, referral and uptake for cataract and specialty surgery, and operational expenses.","['population of 150,000-250,000 in rural areas in North India', '≤10 patients/day) in our 2 operational regions (Vrindavan, Mathura District, and Mohammadi, Kheri District) of Uttar Pradesh']",['Door-to-Door Screening and Awareness Generation Activities'],"['number of walk-in patients, spectacle advise and uptake, referral and uptake for cataract and specialty surgery, and operational expenses', 'uptake of refraction correction and referrals for cataract and other eye conditions']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.125348,"Primary outcomes will be an increase in the number of walk-in patients, spectacle advise and uptake, referral and uptake for cataract and specialty surgery, and operational expenses.","[{'ForeName': 'Shalinder', 'Initials': 'S', 'LastName': 'Sabherwal', 'Affiliation': ""Department of Community Ophthalmology and Public Health Research, Dr Shroff's Charity Eye Hospital, New Delhi, India.""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Chinnakaran', 'Affiliation': ""Department of Community Ophthalmology and Public Health Research, Dr Shroff's Charity Eye Hospital, New Delhi, India.""}, {'ForeName': 'Ishaana', 'Initials': 'I', 'LastName': 'Sood', 'Affiliation': ""Department of Community Ophthalmology and Public Health Research, Dr Shroff's Charity Eye Hospital, New Delhi, India.""}, {'ForeName': 'Gaurav K', 'Initials': 'GK', 'LastName': 'Garg', 'Affiliation': ""Department of Projects and Marketing, Dr Shroff's Charity Eye Hospital, New Delhi, India.""}, {'ForeName': 'Birendra P', 'Initials': 'BP', 'LastName': 'Singh', 'Affiliation': ""Department of Optometry, Dr Shroff's Charity Eye Hospital, New Delhi, India.""}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Shukla', 'Affiliation': 'Indian Institute of Public Health, Hyderabad, India.'}, {'ForeName': 'Priya A', 'Initials': 'PA', 'LastName': 'Reddy', 'Affiliation': ""School of Medicine, Dentistry and Biomedical Sciences, Queen's University, Belfast, United Kingdom.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'Seva Foundation, Berkeley, CA, United States.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Bassett', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Gudlavalleti V S', 'Initials': 'GVS', 'LastName': 'Murthy', 'Affiliation': 'Indian Institute of Public Health, Hyderabad, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'See Acknowledgements, .'}]",JMIR research protocols,['10.2196/31951']
2141,34727422,Effects of Ketamine Versus Midazolam on Neurocognition at 24 Hours in Depressed Patients With Suicidal Ideation.,"Objective:  Subanesthetic ketamine rapidly reduces depressive symptoms and suicidal ideation in some depressed patients. Its effects on neurocognitive functioning in such individuals with significant suicidal ideation is not well understood, even though certain neurocognitive deficits are associated with suicide behavior beyond clinical symptoms.
Methods:  In this study, depressed patients with clinically significant suicidal ideation (n = 78) underwent neuropsychological testing before and 1 day after double-blind treatment with intravenous ketamine (n = 39) or midazolam (n = 39). A subgroup randomized to midazolam whose ideation did not remit after initial infusion received open ketamine and additional neurocognitive testing a day after this treatment. The primary outcome was change in performance on this neurocognitive battery. The study was conducted between November 2012 and January 2017.
Results:  Blinded ketamine produced rapid improvement in suicidal ideation and mood in comparison to midazolam, as we had reported previously. Ketamine, relative to midazolam, was also associated with specific improvement in reaction time (Choice RT) and interference processing/cognitive control (computerized Stroop task)-the latter a measure that has been associated with past suicide attempt in depression. In midazolam nonremitters later treated with open ketamine and retested, reaction time and interference processing/cognitive control also improved relative to both of their prior assessments. Neurocognitive improvement, however, was not correlated with changes in depression, suicidal thinking, or general mood.
Conclusions:  Overall, ketamine was found to have a positive therapeutic effect on neurocognition 1 day after treatment on at least 1 measure associated with suicidal behavior in the context of depression. Results suggest additional independent therapeutic effects for ketamine in the treatment of depressed patients at risk for suicidal behavior.
Trial Registration:  ClinicalTrials.gov identifier: NCT01700829.",2021,"Ketamine, relative to midazolam, was also associated with specific improvement in reaction time (Choice RT) and interference processing/cognitive control (computerized Stroop task)-the latter a measure that has been associated with past suicide attempt in depression.","['November 2012 and January 2017', 'individuals with significant suicidal ideation', 'depressed patients with clinically significant suicidal ideation (n\u2009=\u200978) underwent', 'Depressed Patients With Suicidal Ideation', 'depressed patients at risk for suicidal behavior']","['Subanesthetic ketamine', 'neuropsychological testing', 'midazolam', 'Ketamine', 'Ketamine Versus Midazolam', 'open ketamine', 'ketamine', 'intravenous ketamine']","['change in performance on this neurocognitive battery', 'suicidal behavior', 'reaction time (Choice RT) and interference processing/cognitive control', 'Neurocognitive improvement', 'neurocognitive functioning', 'suicidal ideation and mood', 'Neurocognition', 'depressive symptoms and suicidal ideation', 'reaction time and interference processing/cognitive control', 'depression, suicidal thinking, or general mood']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.141143,"Ketamine, relative to midazolam, was also associated with specific improvement in reaction time (Choice RT) and interference processing/cognitive control (computerized Stroop task)-the latter a measure that has been associated with past suicide attempt in depression.","[{'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Keilp', 'Affiliation': 'Department of Molecular Imaging and Neuropathology, New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Madden', 'Affiliation': 'Department of Molecular Imaging and Neuropathology, New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Marver', 'Affiliation': 'Department of Molecular Imaging and Neuropathology, New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Frawley', 'Affiliation': 'Department of Molecular Imaging and Neuropathology, New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Ainsley K', 'Initials': 'AK', 'LastName': 'Burke', 'Affiliation': 'Department of Molecular Imaging and Neuropathology, New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Mohammad M', 'Initials': 'MM', 'LastName': 'Herzallah', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, New Jersey.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gluck', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, New Jersey.'}, {'ForeName': 'J John', 'Initials': 'JJ', 'LastName': 'Mann', 'Affiliation': 'Department of Molecular Imaging and Neuropathology, New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Grunebaum', 'Affiliation': 'Department of Molecular Imaging and Neuropathology, New York State Psychiatric Institute, New York, New York.'}]",The Journal of clinical psychiatry,['10.4088/JCP.21m13921']
2142,34727839,Individual and Community Social Determinants of Health and Recovery from Alcohol Use Disorder Three Years following Treatment.,"Prior research on recovery from alcohol use disorder (AUD) has often focused on individual-level factors that promote recovery. Given systemic health inequities, it is also important to study community-level social determinants of health (SDOH) that may promote recovery from AUD. This study extended prior work examining individual profiles of recovery from AUD to assess how individual and community SDOH at the time of treatment entry were associated with recovery from AUD three years after treatment. Data were utilized from the COMBINE study ( n  = 664), a multisite randomized clinical trial evaluating pharmacological and behavioral treatments for AUD. Public community data sources associated with participants' study sites were used to measure community SDOH. Multilevel latent profile analyses with individual- and community-level variables as predictors of recovery profiles were estimated. Four profiles were identified based on participants' alcohol consumption and functioning. Individual SDOH variables, such as fewer years of education and lower income, and community SDOH, including lower rates of health insurance, lower income, and greater income inequality, were each associated with lower functioning profiles. The findings highlight the importance of community SDOH in AUD recovery and the value of including both individual and community SDOH variables in research on long-term recovery.",2021,"Individual SDOH variables, such as fewer years of education and lower income, and community SDOH, including lower rates of health insurance, lower income, and greater income inequality, were each associated with lower functioning profiles.",[],[],[],[],[],[],4.0,0.123162,"Individual SDOH variables, such as fewer years of education and lower income, and community SDOH, including lower rates of health insurance, lower income, and greater income inequality, were each associated with lower functioning profiles.","[{'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Swan', 'Affiliation': 'Center on Alcohol, Substance Use, and Addictions and Department of Psychology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Arnie', 'Initials': 'A', 'LastName': 'Aldridge', 'Affiliation': 'Behavioral Health Financing, Economics and Evaluation Department, RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Verlin', 'Initials': 'V', 'LastName': 'Joseph', 'Affiliation': 'Center on Alcohol, Substance Use, and Addictions and Department of Psychology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Jalie A', 'Initials': 'JA', 'LastName': 'Tucker', 'Affiliation': 'Center for Behavioral Economic Health Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Center on Alcohol, Substance Use, and Addictions and Department of Psychology, University of New Mexico, Albuquerque, NM, USA.'}]",Journal of psychoactive drugs,['10.1080/02791072.2021.1986243']
2143,34732523,"Dynamic Recovery: GABA Agonism Restores Neural Variability in Older, Poorer Performing Adults.","Aging is associated with cognitive impairment, but there are large individual differences in these declines. One neural measure that is lower in older adults and predicts these individual differences is moment-to-moment brain signal variability. Testing the assumption that GABA should heighten neural variability, we examined whether reduced brain signal variability in older, poorer performing adults could be boosted by increasing GABA pharmacologically. Brain signal variability was estimated using fMRI in 20 young and 24 older healthy human adults during placebo and GABA agonist sessions. As expected, older adults exhibited lower signal variability at placebo, and, crucially, GABA agonism boosted older adults' variability to the levels of young adults. Furthermore, poorer performing older adults experienced a greater increase in variability on drug, suggesting that those with more to gain benefit the most from GABA system potentiation. GABA may thus serve as a core neurochemical target in future work on aging- and cognition-related human brain dynamics. SIGNIFICANCE STATEMENT  Prior research indicates that moment-to-moment brain signal variability is lower in older, poorer performing adults. We found that this reduced brain signal variability could be boosted through GABA agonism in older adults to the levels of young adults and that this boost was largest in the poorer performing older adults. These results provide the first evidence that brain signal variability can be restored by increasing GABAergic activity and suggest the promise of developing interventions targeting inhibitory systems to help slow cognitive declines in healthy aging.",2021,"As expected, older adults exhibited lower signal variability at placebo, and, crucially, GABA agonism boosted older adults' variability to the levels of young adults.","['Older, Poorer Performing Adults', '20 young and 24 older healthy human adults during', 'older adults']","['GABA', 'Dynamic Recovery: GABA Agonism', 'placebo and GABA agonist sessions']","['brain signal variability', 'Brain signal variability']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242974', 'cui_str': 'GABA Agonist'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.0670651,"As expected, older adults exhibited lower signal variability at placebo, and, crucially, GABA agonism boosted older adults' variability to the levels of young adults.","[{'ForeName': 'Poortata', 'Initials': 'P', 'LastName': 'Lalwani', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor, Michigan 48109-1043.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Garrett', 'Affiliation': 'Max Planck Institute for Human Development, 14195 Berlin, Germany.'}, {'ForeName': 'Thad A', 'Initials': 'TA', 'LastName': 'Polk', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor, Michigan 48109-1043 tpolk@umich.edu.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.0335-21.2021']
2144,34732695,Expectancy effects on serotonin and dopamine transporters during SSRI treatment of social anxiety disorder: a randomized clinical trial.,"It has been extensively debated whether selective serotonin reuptake inhibitors (SSRIs) are more efficacious than placebo in affective disorders, and it is not fully understood how SSRIs exert their beneficial effects. Along with serotonin transporter blockade, altered dopamine signaling and psychological factors may contribute. In this randomized clinical trial of participants with social anxiety disorder (SAD) we investigated how manipulation of verbally-induced expectancies, vital for placebo response, affect brain monoamine transporters and symptom improvement during SSRI treatment. Twenty-seven participants with SAD (17 men, 10 women), were randomized, to 9 weeks of overt or covert treatment with escitalopram 20 mg. The overt group received correct treatment information whereas the covert group was treated deceptively with escitalopram, described as an active placebo in a cover story. Before and after treatment, patients underwent positron emission tomography (PET) assessments with the [ 11 C]DASB and [ 11 C]PE2I radiotracers, probing brain serotonin (SERT) and dopamine (DAT) transporters. SAD symptoms were measured by the Liebowitz Social Anxiety Scale. Overt was superior to covert SSRI treatment, resulting in almost a fourfold higher rate of responders. PET results showed that SERT occupancy after treatment was unrelated to anxiety reduction and equally high in both groups. In contrast, DAT binding decreased in the right putamen, pallidum, and the left thalamus with overt SSRI treatment, and increased with covert treatment, resulting in significant group differences. DAT binding potential changes in these regions correlated negatively with symptom improvement. Findings support that the anxiolytic effects of SSRIs involve psychological factors contingent on dopaminergic neurotransmission while serotonin transporter blockade alone is insufficient for clinical response.",2021,"In contrast, DAT binding decreased in the right putamen, pallidum, and the left thalamus with overt SSRI treatment, and increased with covert treatment, resulting in significant group differences.","['social anxiety disorder', 'Twenty-seven participants with SAD (17 men, 10 women', 'participants with social anxiety disorder (SAD']","['positron emission tomography (PET', 'placebo', 'serotonin and dopamine transporters', 'escitalopram 20\u2009mg']","['SAD symptoms', 'anxiety reduction', 'SERT occupancy', 'Liebowitz Social Anxiety Scale']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Transporter'}, {'cui': 'C1171041', 'cui_str': 'Escitalopram 20 MG'}]","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",27.0,0.0524547,"In contrast, DAT binding decreased in the right putamen, pallidum, and the left thalamus with overt SSRI treatment, and increased with covert treatment, resulting in significant group differences.","[{'ForeName': 'Olof R', 'Initials': 'OR', 'LastName': 'Hjorth', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden. olof.hjorth@psyk.uu.se.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Frick', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Gingnell', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Hoppe', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Vanda', 'Initials': 'V', 'LastName': 'Faria', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hultberg', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Alaie', 'Affiliation': 'Department of Neuroscience, Child and Adolescent Psychiatry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Kristoffer N T', 'Initials': 'KNT', 'LastName': 'Månsson', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Rosén', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Reis', 'Affiliation': 'Department of Biomedical And Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Wahlstedt', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'My', 'Initials': 'M', 'LastName': 'Jonasson', 'Affiliation': 'Department of of Surgical Sciences/Nuclear Medicine and PET, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lubberink', 'Affiliation': 'Department of of Surgical Sciences/Nuclear Medicine and PET, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Antoni', 'Affiliation': 'Department of Medicinal Chemistry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Fredrikson', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Furmark', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}]",Translational psychiatry,['10.1038/s41398-021-01682-3']
2145,34710663,The role of ventromedial and dorsolateral prefrontal cortex in attention and interpretation biases in individuals with general anxiety disorder (GAD): A tDCS study.,"BACKGROUND


and purpose of the study: Individuals with general anxiety disorder (GAD) have deficits in emotional and cognitive processing, including cognitive bias, which plays a causal role in anxiety. Hyperactivity of the ventromedial prefrontal cortex (vmPFC) and dorsolateral prefrontal cortex (dlPFC) is assumed to be involved in cognitive bias. We aimed to explore the causal contribution of the dorsolateral and ventromedial prefrontal cortices (dlPFC, vmPFC) on cognitive bias via non-invasive brain stimulation, and expected a bias-reducing effect of cortical activity enhancement over these areas in GAD, with a larger contribution of the vmPFC to perceptual, and of the dlPFC to interpretation bias.
MATERIAL AND METHODS


The study was conducted in a randomized, single-blinded, and complete crossover design. Thirty-four adults with GAD, received transcranial direct current stimulation (tDCS) in 5 separate sessions (1.5 mA, 20 min) with the following electrode montages: anodal dlPFC/cathodal vmPFC, anodal vmPFC/cathodal dlPFC, anodal dlPFC/cathodal right shoulder, anodal vmPFC/cathodal left shoulder, and sham stimulation. During stimulation, in each session, participants performed the Dot-Probe and Reading Mind from Eyes tests to measure attention and interpretation biases.
RESULTS


A significant effect of stimulation condition on attention and interpretation biases was observed. Anodal vmPFC and dlPFC stimulation coupled with an extracranial cathodal electrode reduced attention bias to threat-related stimuli in the dot-probe test. Furthermore, anodal dlPFC/cathodal vmPFC stimulation reduced negative interpretation bias in reading from eyes test.
CONCLUSION


As suggested by the results of this study, both dlPFC and vmPFC are involved in cognitive bias in GAD, but with partially different roles. Anodal stimulation over the right vmPFC and the left dlPFC reduced attention bias, supporting the relevance of these areas for attention bias. For interpretation bias, the significant effect of anodal dlPFC/cathodal vmPFC stimulation, but only trendwise effect of anodal tDCS over the dlPFC combined with an extracephalic return electrode is in accordance with a predominant effect of the dlPFC on interpretation bias, but does not rule out an additional minor involvement of the vmPFC. Based on these results, a new model is suggested for the neural underpinnings of anxiety symptoms.",2021,"Anodal stimulation over the right vmPFC and the left dlPFC reduced attention bias, supporting the relevance of these areas for attention bias.","['study: Individuals with general anxiety disorder (GAD', 'Thirty-four adults with GAD', 'individuals with general anxiety disorder (GAD']","['Anodal vmPFC and dlPFC stimulation', 'transcranial direct current stimulation (tDCS', 'electrode montages: anodal dlPFC/cathodal vmPFC, anodal vmPFC/cathodal dlPFC, anodal dlPFC/cathodal right shoulder, anodal vmPFC/cathodal left shoulder, and sham stimulation', 'dorsolateral and ventromedial prefrontal cortices (dlPFC, vmPFC', 'ventromedial prefrontal cortex (vmPFC) and dorsolateral prefrontal cortex (dlPFC', 'anodal dlPFC/cathodal vmPFC stimulation']",['attention and interpretation biases'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0524468', 'cui_str': 'Structure of right shoulder region'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C2983598', 'cui_str': 'Dorsolateral'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",34.0,0.0534654,"Anodal stimulation over the right vmPFC and the left dlPFC reduced attention bias, supporting the relevance of these areas for attention bias.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Psychology, Shahid Beheshti University Tehran, Tehran, Po box: 1983969411, Iran. Electronic address: nejati@sbu.ac.ir.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Khalaji', 'Affiliation': 'Department of Psychology, Islamic Azad University, Tehran, Iran. Electronic address: shahrzad.khalaji@yahoo.com.'}, {'ForeName': 'Hesam', 'Initials': 'H', 'LastName': 'Goodarzi', 'Affiliation': 'Department of Psychology, Shahid Beheshti University Tehran, Tehran, Iran. Electronic address: hesamgoodarzi7@yahoo.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nitsche', 'Affiliation': 'Leibniz Research Centre for Working Environment and Human Factors, Department of Psychology and Neurosciences, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany. Electronic address: nitsche@ifado.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.10.034']
2146,34710658,A prospective comparative study of two regimens of diphenylcyclopropenone (DPCP) in the treatment of alopecia areata.,"BACKGROUND


Alopecia areata (AA) is a chronic disorder and the best treatment regimen for it is unknown. Currently, one of the best documented treatment modalities for AA is topical immunotherapy.
AIM


To evaluate the safety and efficacy of a novel method (multi-concentration patch test) versus standard protocol for topical immunotherapy.
METHODS


A prospective randomized clinical trial was conducted on 30 patients with Alopecia areata, half of them received DPCP with a novel method using multi-concentration patch test to determine the optimal initiating concentration of DPCP (case group) and the other half experienced immunotherapy according to the standard protocol (control group). Percentage of hair regrowth after 6 months of treatment and the incidence of drug-related adverse effects were evaluated and compared between the two groups. (IRCT registration code: IRCT20141209020250N5).
RESULTS


Absolute and relative hair regrowth percentages were reported 25% and 41.49% in case group and 8.2% and 14.21% in control group respectively. Considerable response (more than 75% hair regrowth) was observed in 4 (26.6%) patients in case and 1 (6.6%) patient in control group. The clinical response was initiated about 7 weeks sooner in case compared to the control group (14 versus 7.38 weeks, P: 0.001). Overall, clinical response was higher in patients received new protocol, compared to control group. Moreover, patients who experienced new protocol had a higher level of treatment satisfaction in comparison with patients having standard protocol (P: 0.012).
CONCLUSION


This study revealed the effectiveness and safety of the novel multi-concentration patch test DPCP therapy for AA and its priority to conventional method, at least in terms of shortened duration of DPCP immunotherapy.",2021,"The clinical response was initiated about 7 weeks sooner in case compared to the control group (14 versus 7.38 weeks, P: 0.001).","['30 patients with Alopecia areata, half of them received DPCP with a novel method using multi-concentration patch test to determine the optimal initiating concentration of DPCP (case group) and the other half experienced immunotherapy according to the standard protocol (control group', 'alopecia areata', 'Alopecia areata (AA']","['diphenylcyclopropenone (DPCP', 'novel method (multi-concentration patch test']","['incidence of drug-related adverse effects', 'clinical response', 'safety and efficacy', 'relative hair regrowth percentages', 'higher level of treatment satisfaction', 'Percentage of hair regrowth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0058379', 'cui_str': 'diphenylcyclopropenone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030646', 'cui_str': 'Patch test'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0058379', 'cui_str': 'diphenylcyclopropenone'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030646', 'cui_str': 'Patch test'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",30.0,0.0231437,"The clinical response was initiated about 7 weeks sooner in case compared to the control group (14 versus 7.38 weeks, P: 0.001).","[{'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Al Bazzal', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran 1199663911, Iran.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Hatami', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran 1199663911, Iran.'}, {'ForeName': 'Robabeh', 'Initials': 'R', 'LastName': 'Abedini', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran 1199663911, Iran; Department of Dermatology, School of Medicine Razi Hospital, Tehran University of Medical Sciences, Tehran 1199663911, Iran.'}, {'ForeName': 'Ifa', 'Initials': 'I', 'LastName': 'Etesami', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran 1199663911, Iran; Department of Dermatology, School of Medicine Razi Hospital, Tehran University of Medical Sciences, Tehran 1199663911, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Ayanian', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran 1199663911, Iran; Department of Dermatology, Babol University of Medical Sciences, Babol 47176_47745, Iran. Electronic address: aryanian@sina.tums.ac.ir.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Ghandi', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran 1199663911, Iran; Department of Dermatology, School of Medicine Razi Hospital, Tehran University of Medical Sciences, Tehran 1199663911, Iran. Electronic address: nargesghandi@yahoo.com.'}]",International immunopharmacology,['10.1016/j.intimp.2021.108186']
2147,34729823,Telephone-based behavioral activation with mental imagery for depression: A pilot randomized clinical trial in isolated older adults during the Covid-19 pandemic.,"OBJECTIVES


To shield vulnerable persons, particularly the elderly, during the Covid-19 pandemic governments around the world have advised to use social distancing and self-isolation. Social isolation might put older adults at an increased risk for mental health problems such as depression. There is a need for brief, easy-accessible psychological treatments for depressive symptoms that can be delivered remotely. The aim of this study was to investigate the feasibility, acceptability, and preliminary efficacy of telephone-delivered Behavioral Activation with Mental Imagery (BA-MI) for the treatment of depressive symptoms in individuals 65 years and older living in isolation during the Covid-19 pandemic.
METHODS


In this open-label pilot randomized clinical trial, N = 41 individuals aged 65 years or older with clinically significant symptoms of depression were randomly assigned to either a BA-MI treatment condition, or an Attention-Assessment control condition delivered over the telephone over a 4-week period.
RESULTS


Depressive symptoms decreased more in the treatment condition compared to the control condition. At post-treatment, 2 out of 16 participants in the treatment condition met diagnostic criteria for depression compared to 9 out of 13 in the control condition. Most participants in the treatment condition were satisfied with the treatment and few adverse effects were observed.
CONCLUSIONS


This pilot study suggests that behavioral activation with mental imagery delivered over the telephone is feasible, acceptable, and potentially efficacious for the treatment of depressive symptoms in older individuals living in isolation. Replication in larger samples is needed.",2021,At post treatment 2 out of 16 participants in the treatment condition met diagnostic criteria for depression compared to 9 out of 13 in the control condition.,"['N = 41 individuals aged 65 years or older with clinically significant symptoms of depression', 'older individuals living in isolation', 'isolated older adults during the Covid-19 pandemic', 'individuals 65 years and older living in isolation during the covid-19-pandemic']","['telephone-delivered Behavioral Activation with Mental Imagery', 'Behavioral Activation with Mental Imagery treatment condition, or an Attention-Assessment control condition delivered over the telephone over a four week period', 'Telephone-based Behavioral Activation with Mental Imagery']","['adverse effects', 'Depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",41.0,0.0390077,At post treatment 2 out of 16 participants in the treatment condition met diagnostic criteria for depression compared to 9 out of 13 in the control condition.,"[{'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Pellas', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Renner', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Freiburg, Breisgau, Germany.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Ji', 'Affiliation': 'School of Psychological Science, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Damberg', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}]",International journal of geriatric psychiatry,['10.1002/gps.5646']
2148,34734875,The Effectiveness of Telemedical Monitoring Program DiabCare Tirol for Patients with Gestational Diabetes Mellitus.,"The aim of this paper was to evaluate the effect of telemedical care of gestational diabetes mellitus (GDM) patients with the digital treatment pathway model DiabCare Tirol.
METHODS


27 courses of patients with GDM, who were telemonitored through the integrated care program DiabCare Tirol in a diabetes outpatient clinic in Tyrol, Austria during the COVID-19 pandemic in 2020, were analyzed. In addition, randomized controlled trials (RCTs) on telemedicine interventions for GDM were researched, and their results were used for comparison with this disease management method. The patient outcome analysis was used to examine the effects of the integrated care program involving telemonitoring support and compared them to the results of RCTs in which participants were randomly assigned to one of two groups, either mobile monitored or standard treatment group.
RESULTS


The feasibility of the digital treatment pathway model was confirmed in practice, as the trend analysis of the 27 GDM patients involved showed significantly improved glycaemic control. Results of RCT studies tend to support the findings of DiabCare Tirol.
CONCLUSION


Benefits of telemonitoring with integrated care to support conventional therapy cannot be dismissed, especially in times of the pandemic. Continuous outcome research with larger patient numbers will be necessary to confirm the effectiveness of telemonitoring in a regular care setting.",2021,"The feasibility of the digital treatment pathway model was confirmed in practice, as the trend analysis of the 27 GDM patients involved showed significantly improved glycaemic control.","['27 courses of patients with GDM, who were telemonitored through the integrated care program DiabCare Tirol in a diabetes outpatient clinic in Tyrol, Austria during the COVID-19 pandemic in 2020, were analyzed', 'gestational diabetes mellitus (GDM) patients with the digital treatment pathway model DiabCare Tirol', '27 GDM patients', 'Patients with Gestational Diabetes Mellitus']","['mobile monitored or standard treatment group', 'Telemedical Monitoring Program DiabCare Tirol', 'integrated care program involving telemonitoring support']",['glycaemic control'],"[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0103892,"The feasibility of the digital treatment pathway model was confirmed in practice, as the trend analysis of the 27 GDM patients involved showed significantly improved glycaemic control.","[{'ForeName': 'Gihan', 'Initials': 'G', 'LastName': 'El Moazen', 'Affiliation': 'AIT Austrian Institute of Technology GmbH, Graz, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Pfeifer', 'Affiliation': 'AIT Austrian Institute of Technology GmbH, Graz, Austria.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Loid', 'Affiliation': 'Tirol Kliniken GmbH, Innsbruck, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kastner', 'Affiliation': 'AIT Austrian Institute of Technology GmbH, Graz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ciardi', 'Affiliation': 'Krankenhaus St. Vinzenz Zams, Landeck, Austria.'}]",Studies in health technology and informatics,['10.3233/SHTI210599']
2149,34736452,The impact of a maternal mental health intervention on intimate partner violence in Northern Ghana and the mediating roles of social support and couple communication: secondary analysis of a cluster randomized controlled trial.,"BACKGROUNDS


Diverse intervention efforts are implemented to address intimate partner violence (IPV) against women. Via a syndemics theory lens and emerging empirical evidence, mental health interventions demonstrate promise to partially ameliorate IPV. However, the mechanisms of change underlying many IPV interventions are not well understood. These gaps impede our efforts to strengthen or integrate effective components into the current mental health resources, especially in low- and middle-income countries (LMICs). This study aims to examine the impact of a maternal mental health intervention called Integrated Mothers and Babies Course & Early Childhood Development (iMBC/ECD) on IPV and whether social support and/or couple communication mediates the intervention effects among women in rural, Northern Ghana.
METHODS


The current study is a secondary data analysis of a cluster randomized controlled trial. IPV was measured at baseline and 8 months post-intervention (~ 19 months post-baseline). At baseline, 84.8% of the women enrolled in the study (n = 374) reported some type of IPV in the past 12 months. Logistic regression models and multiple mediation analyses were used to address the study aims.
RESULTS


iMBC/ECD did not reduce IPV in the intervention group compared to the control group. Social support and couple communication did not mediate the intervention effects on IPV as indicated by the indirect effects of the multiple mediation models. However, increase in social support reduced women's odds of experiencing emotional violence by 7%, odds ratio (OR) = 0.93, p = 0.007; b = - 0.07, 95% confidence interval (CI) = (- 0.13, - 0.02), and improvement in couple communication demonstrated promise in reducing women's odds of experiencing controlling behaviors by 7%, OR = 0.93, p = 0.07; b = - 0.07, CI = (- 0.14, 0.005), though the improvements were not due to the intervention.
CONCLUSION


This maternal mental health intervention did not reduce IPV; however, the findings extend our knowledge about the impact of such interventions on IPV and the potential mechanisms of change via social support and couple communication. Future research evaluating the impact of mental health interventions on IPV and mechanisms of change is essential for the development of effective interventions. Future programs addressing IPV in LMICs should consider risk factors beyond relationship level (e.g. poverty and gender inequity).
TRIAL REGISTRATION


ClinicalTrials.gov # NCT03665246 , Registered on August 20th, 2018.",2021,Social support and couple communication did not mediate the intervention effects on IPV as indicated by the indirect effects of the multiple mediation models.,"['women in rural, Northern Ghana', 'intimate partner violence in Northern Ghana', 'intimate partner violence (IPV) against women']","['maternal mental health intervention', 'maternal mental health intervention called Integrated Mothers and Babies Course & Early Childhood Development (iMBC/ECD']","['experiencing emotional violence', 'type of IPV', 'IPV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0014116', 'cui_str': 'Endocardial cushion defect'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",,0.0632799,Social support and couple communication did not mediate the intervention effects on IPV as indicated by the indirect effects of the multiple mediation models.,"[{'ForeName': 'Jiepin', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'School of Nursing, Duke University, 307 Trent Drive, Durham, NC, 27705, USA. jiepin.cao@duke.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gallis', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Catholic Relief Services Country Office, Tamale, Ghana.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Lillie', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Safiyatu', 'Initials': 'S', 'LastName': 'Abubakr-Bibilazu', 'Affiliation': 'Catholic Relief Services Country Office, Tamale, Ghana.'}, {'ForeName': 'Haliq', 'Initials': 'H', 'LastName': 'Adam', 'Affiliation': 'Catholic Relief Services Country Office, Tamale, Ghana.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'McEwan', 'Affiliation': 'Catholic Relief Services Head Quarters, Baltimore, MD, USA.'}, {'ForeName': 'John Koku', 'Initials': 'JK', 'LastName': 'Awoonor-Williams', 'Affiliation': 'Ghana Health Service, Accra, Ghana.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hembling', 'Affiliation': 'Catholic Relief Services Head Quarters, Baltimore, MD, USA.'}, {'ForeName': 'Joy Noel', 'Initials': 'JN', 'LastName': 'Baumgartner', 'Affiliation': 'School of Social Work, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",BMC public health,['10.1186/s12889-021-12121-9']
2150,34736419,Clinical efficacy and safety of full-dose versus half-dose corticosteroids plus leflunomide for IgA nephropathy.,"BACKGROUND


The results of leflunomide (LEF) in patients with IgA nephropathy (IgAN) were inconsistent.
METHODS


A total of 149 kidney biopsy-confirmed IgAN patients with an estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73 m 2  and protein excretion levels ≥0.75 g/d were enrolled, with 65 subjects receiving half-dose CS plus LEF (LEF group), and the 84 counterpart patients accepting full-dose corticosteroid (Full CS group). The primary outcomes included the complete remission (CR) rates and incidence of adverse events (AEs). The secondary outcomes were the overall remission (OR) rates and a combined event (eGFR reduced ≥30%, end-stage renal disease [ESRD], hemodialysis, peritoneal dialysis or kidney transplantation).
RESULTS


During the 18 months of follow-up, the CR rates were 72 and 64% in the LEF and Full CS groups (P = 0.299), respectively. The proportion of patients with OR rates in the LEF group and Full CS group was 89% versus 75%, respectively (P = 0.027). Serious AEs were observed only in the Full CS group (P = 0.017). The incidences of total AEs (P = 0.036) and infections (P = 0.024) were lower in the LEF group than in the Full CS group.
CONCLUSIONS


LEF combined with half-dose CS is superior to full-dose CS in the treatment of IgAN.",2021,"The incidences of total AEs (P = 0.036) and infections (P = 0.024) were lower in the LEF group than in the Full CS group.
","['149 kidney biopsy-confirmed IgAN patients with an estimated glomerular filtration rate (eGFR)\u2009≥\u200950\u2009ml', '65 subjects receiving half-dose CS plus LEF (LEF group), and the 84 counterpart patients', 'patients with IgA nephropathy (IgAN', 'IgA nephropathy']","['LEF', 'full-dose versus half-dose corticosteroids plus leflunomide', 'accepting full-dose corticosteroid', 'leflunomide (LEF']","['incidences of total AEs', 'overall remission (OR) rates and a combined event (eGFR reduced ≥30%, end-stage renal disease [ESRD], hemodialysis, peritoneal dialysis or kidney transplantation', 'Clinical efficacy and safety', 'complete remission (CR) rates and incidence of adverse events (AEs', 'proportion of patients with OR rates', 'CR rates']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",149.0,0.169601,"The incidences of total AEs (P = 0.036) and infections (P = 0.024) were lower in the LEF group than in the Full CS group.
","[{'ForeName': 'Yebei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, The Second Affiliated Hospital of Nanchang University, No. 1, Minde Road, Donghu District, Nanchang, 330006, P.R. China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Department of Nephrology, The Second Affiliated Hospital of Nanchang University, No. 1, Minde Road, Donghu District, Nanchang, 330006, P.R. China.'}, {'ForeName': 'Tianlun', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Nephrology, The Second Affiliated Hospital of Nanchang University, No. 1, Minde Road, Donghu District, Nanchang, 330006, P.R. China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, The Second Affiliated Hospital of Nanchang University, No. 1, Minde Road, Donghu District, Nanchang, 330006, P.R. China.'}, {'ForeName': 'Gaosi', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Nephrology, The Second Affiliated Hospital of Nanchang University, No. 1, Minde Road, Donghu District, Nanchang, 330006, P.R. China. gaosixu@163.com.'}]",BMC nephrology,['10.1186/s12882-021-02555-z']
2151,34731696,Antihypertensive drug class in combination with lipid lowering treatment for primary prevention of cardiovascular disease in the elderly.,"BACKGROUND


Antihypertensives and lipid-lowering therapy (LLT) are often used concurrently.
OBJECTIVES


To determine whether there was a difference in clinical outcomes when older patients with LLT were prescribed angiotensin-converting-enzyme-inhibitors (ACE-Is) compared with diuretics.
METHODS


This analysis included 648 LLT older users free of cardiovascular disease (CVD) from a trial comparing ACE-I versus diuretic-based therapy. Comparisons were made between LLT+ACE-I (n = 335) and LLT+diuretic groups (n = 313) using multivariable Cox proportional-hazard models. Primary endpoints were all-cause and CVD mortality (in-trial [4.1-year]+post-trial [6.9-year]) and secondary endpoints (in-trial) were the composite of all-cause mortality and first CVD events and its components, CVD mortality and incident diabetes.
RESULTS


There were no significant differences between the two groups for the primary endpoints over the in-trial plus post-trial follow-up, nor was there a difference for any secondary outcomes over the in-trial follow-up.
CONCLUSIONS


The LLT+ACE-I and LLT+diuretic combinations showed similar effects in CVD-free older individuals. Randomised trials are needed to provide conclusive evidence.",2021,"There were no significant differences between the two groups for the primary endpoints over the in-trial plus post-trial follow-up, nor was there a difference for any secondary outcomes over the in-trial follow-up.
","['older patients with LLT', 'primary prevention of cardiovascular disease in the elderly', '648 LLT older users free of cardiovascular disease (CVD) from a trial comparing']","['lipid-lowering therapy (LLT', 'lipid lowering treatment', 'ACE-I versus diuretic-based therapy', 'angiotensin-converting-enzyme-inhibitors (ACE-Is) compared with diuretics']","['composite of all-cause mortality and first CVD events and its components, CVD mortality and incident diabetes', 'cause and CVD mortality']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C2585889', 'cui_str': 'Primary prevention of cardiovascular disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",648.0,0.348154,"There were no significant differences between the two groups for the primary endpoints over the in-trial plus post-trial follow-up, nor was there a difference for any secondary outcomes over the in-trial follow-up.
","[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool street, Hobart TAS 7000, Australia. Electronic address: zhen.zhou@utas.edu.au.'}, {'ForeName': 'Enayet K', 'Initials': 'EK', 'LastName': 'Chowdhury', 'Affiliation': 'School of Population Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Breslin', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool street, Hobart TAS 7000, Australia.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Curtis', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Population Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool street, Hobart TAS 7000, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2021.09.005']
2152,34698782,Effect of Platelet-Rich Plasma Injections vs Placebo on Ankle Symptoms and Function in Patients With Ankle Osteoarthritis: A Randomized Clinical Trial.,"Importance


Approximately 3.4% of adults have ankle (tibiotalar) osteoarthritis and, among younger patients, ankle osteoarthritis is more common than knee and hip osteoarthritis. Few effective nonsurgical interventions exist, but platelet-rich plasma (PRP) injections are widely used, with some evidence of efficacy in knee osteoarthritis.
Objective


To determine the effect of PRP injections on symptoms and function in patients with ankle osteoarthritis.
Design, Setting, and Participants


A multicenter, block-randomized, double-blinded, placebo-controlled clinical trial performed at 6 sites in the Netherlands that included 100 patients with pain greater than 40 on a visual analog scale (range, 0-100) and tibiotalar joint space narrowing. Enrollment began on August 24, 2018, and follow-up was completed on December 3, 2020.
Interventions


Patients were randomly assigned (1:1) to receive 2 ultrasonography-guided intra-articular injections of either PRP (n = 48) or placebo (saline; n = 52).
Main Outcomes and Measures


The primary outcome was the validated American Orthopaedic Foot and Ankle Society score (range, 0-100; higher scores indicate less pain and better function; minimal clinically important difference, 12 points) over 26 weeks.
Results


Among 100 randomized patients (mean age, 56 years; 45 [45%] women), no patients were lost to follow-up for the primary outcome. Compared with baseline values, the mean American Orthopaedic Foot and Ankle Society score improved by 10 points in the PRP group (from 63 to 73 points [95% CI, 6-14]; P < .001) and 11 points in the placebo group (from 64 to 75 points [95% CI, 7-15]; P < .001). The adjusted between-group difference over 26 weeks was -1 ([95% CI, -6 to 3]; P = .56). One serious adverse event was reported in the placebo group, which was unrelated to the intervention; there were 13 other adverse events in the PRP group and 8 in the placebo group.
Conclusions and Relevance


Among patients with ankle osteoarthritis, intra-articular PRP injections, compared with placebo injections, did not significantly improve ankle symptoms and function over 26 weeks. The results of this study do not support the use of PRP injections for ankle osteoarthritis.
Trial Registration


Netherlands Trial Register: NTR7261.",2021,"One serious adverse event was reported in the placebo group, which was unrelated to the intervention; there were 13 other adverse events in the PRP group and 8 in the placebo group.
","['Patients With Ankle Osteoarthritis', '100 patients with pain greater than 40 on a visual analog scale (range, 0-100) and tibiotalar joint space narrowing', '100 randomized patients (mean age, 56 years', 'patients with ankle osteoarthritis']","['Platelet-Rich Plasma Injections vs Placebo', 'PRP injections', 'placebo', '2 ultrasonography-guided intra-articular injections of either PRP (n\u2009=\u200948) or placebo (saline; n\u2009=\u200952']","['ankle symptoms and function', 'adverse events', 'mean American Orthopaedic Foot and Ankle Society score', 'validated American Orthopaedic Foot and Ankle Society score', 'Ankle Symptoms and Function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409931', 'cui_str': 'Osteoarthritis of ankle'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C2127215', 'cui_str': 'Symptom of ankle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.499046,"One serious adverse event was reported in the placebo group, which was unrelated to the intervention; there were 13 other adverse events in the PRP group and 8 in the placebo group.
","[{'ForeName': 'Liam D A', 'Initials': 'LDA', 'LastName': 'Paget', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopedic Surgery, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Gustaaf', 'Initials': 'G', 'LastName': 'Reurink', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopedic Surgery, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'de Vos', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Weir', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Maarten H', 'Initials': 'MH', 'LastName': 'Moen', 'Affiliation': 'The Sport Physician Group, Department of Sports Medicine, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Sita M A', 'Initials': 'SMA', 'LastName': 'Bierma-Zeinstra', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Sjoerd A S', 'Initials': 'SAS', 'LastName': 'Stufkens', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopedic Surgery, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopedic Surgery, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes L', 'Initials': 'JL', 'LastName': 'Tol', 'Affiliation': 'Academic Center for Evidence-based Sports medicine (ACES), Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2021.16602']
2153,34700212,Site-independent confirmation of primary site-based PANSS ratings in a schizophrenia trial.,"Blinded, site-independent (remote) ratings from audio-digital recordings of site-based Positive and Negative Syndrome Scale (PANSS) interviews were obtained in a 5-week, randomized, double-blinded study assessing the safety, tolerability, and efficacy of KarXT (a fixed combination of xanomeline and trospium chloride) in hospitalized adults with schizophrenia experiencing an acute exacerbation of psychosis (EMERGENT-1; ClinicalTrials.gov identifier: NCT3697252). The blinded site-independent raters had no knowledge of site location, study visit, drug vs. placebo assignment, or any treatment emergent adverse events (TEAEs). Concordance analyses of 561 paired site-based and site-independent PANSS ratings across all visits revealed a high correlation (ICC = 0.775). Paired scoring differences were positively correlated with the PANSS total score (Spearman's rho = 0.37, p < 0.0001). Paired PANSS scores were available from 148 subjects at both the baseline and end of study visits (KarXT = 72, Placebo = 76). Site-based PANSS total scores (primary aim) revealed a significantly greater improvement from baseline in the KarXT group compared to the placebo group (p < 0.0001). The blinded site-independent PANSS total scores derived from listening to and scoring the recorded site-based PANSS interviews replicated this finding (p < 0.001) and yielded an overall predictive value of 85.1% for matching the site-based response/non-response outcomes. TEAE's have the potential to ""unblind"" site-based ratings. In this study, the site-independent raters were blinded to TEAEs, affirmed the site-based PANSS ratings, and mitigated concerns about possible functional unblinding of site-based raters. This method of blinded assessment via audio-digital recordings may have utility for other studies concerned with ratings precision and/or functional unblinding.",2021,Site-based PANSS total scores (primary aim) revealed a significantly greater improvement from baseline in the KarXT group compared to the placebo group (p < 0.0001).,['hospitalized adults with schizophrenia experiencing an acute exacerbation of psychosis'],"['placebo', 'KarXT', 'KarXT (a fixed combination of xanomeline and trospium chloride']","['PANSS total score', 'safety, tolerability, and efficacy']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0246836', 'cui_str': 'xanomeline'}, {'cui': 'C0077408', 'cui_str': 'Trospium chloride'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.441379,Site-based PANSS total scores (primary aim) revealed a significantly greater improvement from baseline in the KarXT group compared to the placebo group (p < 0.0001).,"[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Targum', 'Affiliation': 'Signant Health, Boston, MA, USA. Electronic address: sdtargum@yahoo.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': 'Signant Health, Boston, MA, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Breier', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Brannan', 'Affiliation': 'Karuna Therapeutics, Boston, MA, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.10.027']
2154,34708788,Outcomes of preoperative bevacizumab in diabetics with nonclearing vitreous hemorrhage without tractional detachment - A quasi-randomized retrospective study.,"Purpose


To assess whether preoperative bevacizumab (BVZ) in treatment-naïve eyes with proliferative diabetic retinopathy (PDR) and vitreous hemorrhage (VH) without tractional retinal detachment (TRD) leads to lesser macular edema and better visual outcome compared to eyes that do not receive BVZ.
Methods


This quasi-randomized retrospective study included 217 treatment-naïve eyes with nonclearing VH without TRD that had vitrectomy with or without BVZ and had a minimum 6-months follow-up. Postoperative variables, including visual acuity (BCVA), central macular thickness (CMT) at 1 month, and need for additional anti-VEGF injections till 6 months follow-up, were recorded for analysis.
Results


Of the 217 eyes, 107 eyes (49%) received preoperative BVZ and 110 (51%) did not. Groups were comparable in terms of preoperative characteristics. At 1 month, mean CMT was significantly higher in eyes without BVZ (310 ± 33 m vs. 246 ± 34m; P < 0.001). The likelihood of developing center-involving DME at 1 month after vitrectomy was 67% lower if the eye received preoperative BVZ (OR = 0.33, 95%CI = 0.18-2.54, P = 0.56). Though BCVA improved significantly in both groups at 1 month, it was 1/3 rd  of a line better in the BVZ group (b coefficient = -0.035 logMAR, 95%CI = -0.04 to -0.008 logMAR, P = 0.01).
Conclusion


Preoperative BVZ in treatment-naïve eyes with PDR and VH but without TRD lead to better macular status and marginally improved vision at 1 month, which was maintained at 6 months. In view of these results, patients may be offered BVZ only when it is readily affordable to them.",2021,"The likelihood of developing center-involving DME at 1 month after vitrectomy was 67% lower if the eye received preoperative BVZ (OR = 0.33, 95%CI = 0.18-2.54, P = 0.56).","['diabetics with nonclearing vitreous hemorrhage without tractional detachment - A quasi', '217 treatment-naïve eyes with nonclearing VH without TRD that had vitrectomy with or without BVZ and had a minimum 6-months follow-up', 'treatment-naïve eyes with proliferative diabetic retinopathy (PDR) and vitreous hemorrhage (VH) without tractional retinal detachment (TRD']","['preoperative bevacizumab (BVZ', 'preoperative bevacizumab']","['BCVA', 'likelihood of developing center-involving DME', 'mean CMT', 'visual acuity (BCVA), central macular thickness (CMT) at 1 month, and need for additional anti-VEGF injections']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0154828', 'cui_str': 'Traction detachment of retina'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0058217', 'cui_str': 'dimethyl ether'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",217.0,0.0933207,"The likelihood of developing center-involving DME at 1 month after vitrectomy was 67% lower if the eye received preoperative BVZ (OR = 0.33, 95%CI = 0.18-2.54, P = 0.56).","[{'ForeName': 'Debdulal', 'Initials': 'D', 'LastName': 'Chakraborty', 'Affiliation': 'Department of Vitreo-Retina, Disha Eye Hospitals, 88 Ghosh Para Road Barrackpore, Kolkata, India.'}, {'ForeName': 'Aniruddha', 'Initials': 'A', 'LastName': 'Maiti', 'Affiliation': 'Department of Vitreo-Retina, Susrut Eye Hospital, Salt Lake, Kolkata, India.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Kelkar', 'Affiliation': 'Department of Vitreo-Retina, National Institute of Ophthalmology,(NIO), Pune, Maharashtra, India.'}, {'ForeName': 'Sabyasachi', 'Initials': 'S', 'LastName': 'Sengupta', 'Affiliation': 'Department of Vitreo-Retina, Future Vision Eye Care and Research Centre, Mumbai, Maharashtra, India.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'Department of Vitreo-Retina, Susrut Eye Hospital, Salt Lake, Kolkata, India.'}, {'ForeName': 'Mounika', 'Initials': 'M', 'LastName': 'Bolisetty', 'Affiliation': 'Department of Vitreo-Retina, National Institute of Ophthalmology,(NIO), Pune, Maharashtra, India.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Kothari', 'Affiliation': 'Department of Vitreo-Retina, National Institute of Ophthalmology,(NIO), Pune, Maharashtra, India.'}, {'ForeName': 'Jaydeep', 'Initials': 'J', 'LastName': 'Majumder', 'Affiliation': 'Department of Vitreo-Retina, Susrut Eye Hospital, Salt Lake, Kolkata, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1264_21']
2155,34733453,Clinical Observation on the Treatment of Rotator Cuff Injury with Modified Buyang Huanwu Decoction and Rotator Cuff Repair.,"In this paper, we have evaluated the clinical efficacy of rotator cuff surgery combined with Chinese medicine Buyang Huanwu Decoction (adding medicine) in the treatment of patients with rotator cuff injury. For this purpose, sixty patients with rotator cuff injury and shoulder arthroscopic surgery were selected in this hospital (where 57 cases were finally screened). The patients were divided into a control group (28 cases) and a study group (29 cases) by the envelope method. The control group received conventional treatment after the operation, whereas the study group was combined with Buyang Huanwu Decoction after the operation. The clinical efficacy of the two groups, particularly after treatment, was compared in terms of self-care ability and Constant-Murley scores before and after treatment, that is, 4 w, 8 w, and 12 w. The total effective rate of treatment in the study group was significantly higher than that of the control group after 4 weeks of treatment ( P  < 0.05). There was no significant difference in the FIM self-care scores of the two groups before treatment ( P  > 0.05). In the study group patients, after treatment for 4 w and 8 w, the FIM self-care score was significantly improved ( P  < 0.05). The FIM self-care score of the patients in the study group, after 12 w of treatment, had no significant difference compared with the control group ( P  > 0.05). The Constant-Murley scores of the two groups were compared before treatment where no significant difference is observed ( P  > 0.05) and the Constant-Murley score of the study group patients was significantly higher than that of the control group, after 4 w and 8 w treatment ( P  < 0.05). Additionally, Constant-Murley score of the study group was not significantly higher than that of the control group after 12 w of treatment difference ( P  > 0.05). The proposed combined treatment program has value of promotion and implementation in the clinical treatment of patients with rotator cuff injury.",2021,There was no significant difference in the FIM self-care scores of the two groups before treatment ( P  > 0.05).,"['patients with rotator cuff injury', 'sixty patients with rotator cuff injury and shoulder arthroscopic surgery were selected in this hospital (where 57 cases were finally screened']","['Modified Buyang Huanwu Decoction and Rotator Cuff Repair', 'conventional treatment', 'Buyang Huanwu Decoction', 'rotator cuff surgery combined with Chinese medicine Buyang Huanwu Decoction (adding medicine']","['total effective rate', 'FIM self-care score', 'self-care ability and Constant-Murley scores', 'FIM self-care scores', 'Constant-Murley score', 'Constant-Murley scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851122', 'cui_str': 'Injury of rotator cuff'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1137699', 'cui_str': 'buyang huanwu'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform personal care activity'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",60.0,0.0374412,There was no significant difference in the FIM self-care scores of the two groups before treatment ( P  > 0.05).,"[{'ForeName': 'Gangfeng', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': ""The First People's Hospital of Xiaoshan District, Xiaoshan District, Hangzhou 311200, China.""}, {'ForeName': 'Zhennan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The Second Clinical Medical College, Zhejiang Chinese Medicine University, Hangzhou 310053, China.'}, {'ForeName': 'Haonan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'The First Clinical Medical College, Zhejiang Chinese Medicine University, Hangzhou 310053, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Guan', 'Affiliation': 'The Second Clinical Medical College, Zhejiang Chinese Medicine University, Hangzhou 310053, China.'}]",Journal of healthcare engineering,['10.1155/2021/3088160']
2156,34726653,"Do Single-Family Rooms Increase Parental Presence, Involvement, and Maternal Well-Being in Neonatal Intensive Care?","Objectives of this study were to determine whether single-family room (SFR) design enhances parental presence, involvement, and maternal well-being during neonatal intensive care hospitalization. An observational cohort including mothers of infants was randomly assigned to receive care in a tertiary-level open-bay (OB) (n = 35) or SFR (n = 36). Mothers were asked to complete daily diaries documenting parental presence, involvement in care, and questionnaires examining maternal well-being. Mother and father mean presence (standard deviation) was significantly higher in the SFR-17.4 (5.2) and 13.6 (6.8)-compared to OB-11.9 (6.3) and 4.6 (3.7) hours/day. Total time spent in care activities did not differ for mothers, except SFR mothers spent more time expressing breast milk (EBM). SFR fathers had greater involvement with care activities. There were no other significant differences. The SFR was associated with greater maternal presence, but not greater involvement in care activities except for EBM, nor improved maternal well-being. The SFR appears to have greater impact on fathers' involvement in care and comforting activities, although the amount of time involved remained quite low compared with mothers. Further studies examining ways to enhance parental involvement in the neonatal intensive care unit are warranted.",2021,"The SFR was associated with greater maternal presence, but not greater involvement in care activities except for EBM, nor improved maternal well-being.",[],"['care in a tertiary-level open-bay (OB', 'single-family room (SFR', 'SFR']","['time expressing breast milk (EBM', 'Total time spent in care activities']",[],"[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0452739', 'cui_str': 'Expressed breast milk'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",36.0,0.02607,"The SFR was associated with greater maternal presence, but not greater involvement in care activities except for EBM, nor improved maternal well-being.","[{'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Campbell-Yeo', 'Affiliation': 'IWK Health, Halifax, Nova Scotia, Canada (Drs Campbell-Yeo, Kim, Dorling, Macmillan, Mcgrath, Simpson, and Wozney and Mss Bishop, Delahunty-Pike, Glover, Inglis, Johnson, Monaghan, Skinner, and Whitehead); Faculty of Health, School of Nursing, Dalhousie University, Halifax, Nova Scotia, Canada (Drs Campbell-Yeo, Disher, Richardson, and Dol); Department of Pediatrics (Drs Campbell-Yeo, Dorling, Macmillan, Simpson) and Department of Psychiatry (Dr Mcgrath), Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; and Department of Medical Sciences, Faculty of Science, Dalhousie University, Halifax, Nova Scotia, Canada (Ms Orovec).'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Disher', 'Affiliation': ''}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Dol', 'Affiliation': ''}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Bishop', 'Affiliation': ''}, {'ForeName': 'Alannah', 'Initials': 'A', 'LastName': 'Delahunty-Pike', 'Affiliation': ''}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Glover', 'Affiliation': ''}, {'ForeName': 'Darlene', 'Initials': 'D', 'LastName': 'Inglis', 'Affiliation': ''}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Macmillan', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mcgrath', 'Affiliation': ''}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Monaghan', 'Affiliation': ''}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Orovec', 'Affiliation': ''}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Simpson', 'Affiliation': ''}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Skinner', 'Affiliation': ''}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Whitehead', 'Affiliation': ''}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Wozney', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of perinatal & neonatal nursing,['10.1097/JPN.0000000000000600']
2157,34726850,A 20-year split-mouth comparative study of two screw-shaped titanium implant systems.,"PURPOSE


To prospectively assess marginal bone loss and implant survival with Astra Tech (Dentsply Sirona, Charlotte, NC, USA) (group A) and Brånemark (Nobel Biocare, Zurich, Switzerland) (group B) implants in a split-mouth study conducted over a 20-year follow-up period.
MATERIALS AND METHODS


A total of 95 implants (n = 50, group A and n = 45, group B) were randomly placed in the left or right side of the maxilla or mandible in 18 patients. Clinical and radiographic examinations were performed, and results were reported at 5, 10, 15 and 20 years after insertion of the prosthesis.
RESULTS


Ten patients were followed up for 20 years (n = 26 implants, group A and n = 25 implants, group B). No implant loss or prosthetic failures were observed. After 20 years of follow-up, no significant differences in marginal bone loss were found between both implant groups (P = 0.25). The proportion of marginal bone loss ≥ 0.5 mm was not significantly different between implant types (P > 0.05), and no statistically significant relationships were found between marginal bone loss and time (P ≥ 0.05). More specifically, there was no significant difference in marginal bone level between year 20 and baseline in group A (P = 0.70), whereas a difference of 0.5 to 1.0 mm was found in group B (P = 0.15).
CONCLUSIONS


After 20 years of follow-up, marginal bone loss around screw-shaped titanium implants was clinically insignificant. Furthermore, no significant differences in survival and marginal bone loss were found between group A and B implants over the follow-up period.",2021,"The proportion of marginal bone loss ≥ 0.5 mm was not significantly different between implant types (P > 0.05), and no statistically significant relationships were found between marginal bone loss and time (P ≥ 0.05).",[],"['Astra Tech (Dentsply Sirona, Charlotte, NC, USA', 'screw-shaped titanium implant systems']","['marginal bone loss and time', 'proportion of marginal bone loss', 'marginal bone level', 'marginal bone loss', 'survival and marginal bone loss', 'marginal bone loss and implant survival', 'implant loss or prosthetic failures']",[],"[{'cui': 'C0112984', 'cui_str': 'Dentsply'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",10.0,0.0237904,"The proportion of marginal bone loss ≥ 0.5 mm was not significantly different between implant types (P > 0.05), and no statistically significant relationships were found between marginal bone loss and time (P ≥ 0.05).","[{'ForeName': 'Reinhilde', 'Initials': 'R', 'LastName': 'Jacobs', 'Affiliation': ''}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Quirynen', 'Affiliation': ''}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'De Mars', 'Affiliation': ''}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Dekeyser', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'van Steenberghe', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Vrombaut', 'Affiliation': ''}, {'ForeName': 'Sohaib', 'Initials': 'S', 'LastName': 'Shujaat', 'Affiliation': ''}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Naert', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
2158,34739060,Assessment of Discrepancies Between Follow-up Infarct Volume and 90-Day Outcomes Among Patients With Ischemic Stroke Who Received Endovascular Therapy.,"Importance


Some patients have poor outcomes despite small infarcts after endovascular therapy (EVT), while others with large infarcts do well. Understanding why these discrepancies occur may help to optimize EVT outcomes.
Objective


To validate exploratory findings from the Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial regarding pretreatment, treatment-related, and posttreatment factors associated with discrepancies between follow-up infarct volume (FIV) and 90-day functional outcome.
Design, Setting, and Participants


This cohort study is a post hoc analysis of the Safety and Efficacy of Nerinetide in Subjects Undergoing Endovascular Thrombectomy for Stroke (ESCAPE-NA1) trial, a double-blind, randomized, placebo-controlled, international, multicenter trial conducted from March 2017 to August 2019. Patients who participated in ESCAPE-NA1 and had available 90-day modified Rankin Scale (mRS) scores and 24-hour to 48-hour posttreatment follow-up parenchymal imaging were included.
Exposures


Small FIV (volume ≤25th percentile) and large FIV (volume ≥75th percentile) on 24-hour computed tomography/magnetic resonance imaging. Baseline factors, outcomes, treatments, and poststroke serious adverse events (SAEs) were compared between discrepant cases (ie, patients with 90-day mRS score ≥3 despite small FIV or those with mRS scores ≤2 despite large FIV) and nondiscrepant cases.
Main Outcomes and Measures


Area under the curve (AUC) and goodness of fit of prespecified logistic models, including pretreatment (eg, age, cancer, vascular risk factors) and treatment-related and posttreatment (eg, SAEs) factors, were compared with stepwise regression-derived models for ability to identify small FIV with higher mRS score and large FIV with lower mRS score.
Results


Among 1091 patients (median [IQR] age, 70.8 [60.8-79.8] years; 549 [49.7%] women; median [IQR] FIV, 24.9 mL [6.6-92.2 mL]), 42 of 287 patients (14.6%) with FIV of 7 mL or less (ie, ≤25th percentile) had an mRS score of at least 3; 65 of 275 patients (23.6%) with FIV of 92 mL or greater (ie, ≥75th percentile) had an mRS score of 2 or less. Prespecified models of pretreatment factors (ie, age, cancer, vascular risk factors) associated with low FIV and higher mRS score performed similarly to models selected by stepwise regression (AUC, 0.92 [95% CI, 0.89-0.95] vs 0.93 [95% CI, 0.90-0.95]; P = .42). SAEs, specifically infarct in new territory, recurrent stroke, pneumonia, and congestive heart failure, were associated with low FIV and higher mRS scores; stepwise models also identified 24-hour hemoglobin as treatment-related/posttreatment factor (AUC, 0.92 [95% CI, 0.90-0.95] vs 0.94 [95% CI, 0.91-0.96]; P = .14). Younger age was associated with high FIV and lower mRS score; stepwise models identified absence of diabetes and higher baseline hemoglobin as additional pretreatment factors (AUC, 0.76 [95% CI, 0.70-0.82] vs 0.77 [95% CI, 0.71-0.83]; P = .82). Absence of SAEs, especially stroke progression, symptomatic intracerebral hemorrhage, and pneumonia, was associated with high FIV and lower mRS score2; stepwise models also identified 24-hour hemoglobin level, glucose, and diastolic blood pressure as posttreatment factors associated with discrepant cases (AUC, 0.80 [95% CI, 0.74-0.87] vs 0.79 [95% CI, 0.72-0.86]; P = .92).
Conclusions and Relevance


In this study, discrepancies between functional outcome and post-EVT infarct volume were associated with differences in pretreatment factors, such as age and comorbidities, and posttreatment complications related to index stroke evolution, secondary prevention, and quality of stroke unit care. Besides preventing such complications, optimization of blood pressure, glucose levels, and hemoglobin levels are potentially modifiable factors meriting further study.",2021,"Absence of SAEs, especially stroke progression, symptomatic intracerebral hemorrhage, and pneumonia, was associated with high FIV and lower mRS score2; stepwise models also identified 24-hour hemoglobin level, glucose, and diastolic blood pressure as posttreatment factors associated with discrepant cases (AUC, 0.80 [95% CI, 0.74-0.87] vs 0.79 [95% CI, 0.72-0.86]; P = .92).
","['Patients With Ischemic Stroke', 'Subjects', 'Patients who participated in ESCAPE-NA1 and had available 90-day modified Rankin Scale (mRS) scores and 24-hour to 48-hour posttreatment follow-up parenchymal imaging were included', '1091 patients (median [IQR] age, 70.8 [60.8-79.8] years; 549 [49.7%] women; median [IQR] FIV, 24.9 mL [6.6-92.2 mL]), 42 of 287 patients (14.6%) with FIV of 7 mL or less (ie, ≤25th percentile) had an mRS score of at least 3; 65 of 275 patients (23.6%) with FIV of 92 mL or greater (ie, ≥75th percentile) had an mRS score of 2 or less', 'March 2017 to August 2019']","['Endovascular Therapy', 'endovascular therapy (EVT', 'placebo']","['blood pressure, glucose levels, and hemoglobin levels', 'Baseline factors, outcomes, treatments, and poststroke serious adverse events (SAEs', 'Exposures\n\n\nSmall FIV (volume ≤25th percentile) and large FIV (volume ≥75th percentile', '24-hour hemoglobin level, glucose, and diastolic blood pressure', 'Absence of SAEs, especially stroke progression, symptomatic intracerebral hemorrhage, and pneumonia', 'SAEs, specifically infarct in new territory, recurrent stroke, pneumonia, and congestive heart failure', 'Measures\n\n\nArea under the curve (AUC) and goodness of fit of prespecified logistic models, including pretreatment (eg, age, cancer, vascular risk factors) and treatment-related and posttreatment (eg, SAEs) factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0524613', 'cui_str': 'New Territories'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0023965', 'cui_str': 'Logistic Model'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",,0.206062,"Absence of SAEs, especially stroke progression, symptomatic intracerebral hemorrhage, and pneumonia, was associated with high FIV and lower mRS score2; stepwise models also identified 24-hour hemoglobin level, glucose, and diastolic blood pressure as posttreatment factors associated with discrepant cases (AUC, 0.80 [95% CI, 0.74-0.87] vs 0.79 [95% CI, 0.72-0.86]; P = .92).
","[{'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Ganesh', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Ospel', 'Affiliation': 'Department of Radiology, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Bijoy K', 'Initials': 'BK', 'LastName': 'Menon', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'McTaggart', 'Affiliation': 'Departments of Diagnostic Imaging, Neurology, and Neurosurgery, The Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': 'Departments of Neurology, Neurosurgery, and Radiology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Alexandre Y', 'Initials': 'AY', 'LastName': 'Poppe', 'Affiliation': ""Department of Neurosciences, Centre Hospitalier de l'Université de Montréal (CHUM), Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Almekhlafi', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Ricardo A', 'Initials': 'RA', 'LastName': 'Hanel', 'Affiliation': 'Lyerly Neurosurgery, Baptist Hospital, Jacksonville, Florida.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Thomalla', 'Affiliation': 'Departments of Neurology and Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Holmin', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet and Departments of Neuroradiology and Neurology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Puetz', 'Affiliation': 'Dresden Neurovascular Center, Department of Neurology, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'van Adel', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Tarpley', 'Affiliation': ""Providence Little Company of Mary Medical Center, Providence Saint John's Health Center and The Pacific Neuroscience Institute, Torrance, California.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tymianski', 'Affiliation': 'Division of Neurosurgery and Neurovascular Therapeutics Program, University Health Network, Departments of Surgery and Physiology, University of Toronto, Toronto Western Hospital Research Institute, Toronto, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2021.32376']
2159,34739064,"Screening in High Schools to Identify, Evaluate, and Lower Depression Among Adolescents: A Randomized Clinical Trial.","Importance


Adolescent major depressive disorder (MDD) prevalence has nearly doubled in the past decade. The US Preventive Services Task Force endorses universal adolescent MDD screening in primary care; however, most adolescents lack preventive health care, resulting in worsening disparities in MDD screening and treatment.
Objective


To evaluate the effectiveness of universal adolescent MDD screening in the school setting in an effort to reduce disparities and improve MDD identification and treatment initiation.
Design, Setting, and Participants


This randomized clinical trial, conducted from November 6, 2018, to November 20, 2020, compared the usual school practice of targeted or selected screening based on observable behaviors of concern with universal MDD screening. Students within an identified school were randomized by grade to 1 of the 2 study groups. Study groups were compared using mixed-effects logistic regression. Participants included students in grades 9 through 12 enrolled at 1 of the 14 participating Pennsylvania public high schools.
Interventions


In targeted screening, students with behaviors prompting concern for MDD were referred to the Student Assistance Program (SAP), mandated in all Pennsylvania schools. The SAP determined follow-up recommendations. In universal screening, all students completed the Patient Health Questionnaire-9 (PHQ-9); students with positive scores proceeded to SAP. The universal screening group could also have targeted referral to SAP for concerning behavior independent of the PHQ-9.
Main Outcomes and Measures


The primary outcome was initiation of MDD treatment or services based on data collected by school SAP teams during the academic year.
Results


A total of 12 909 students were included (median age, 16 years [range, 13-21 years]; 6963 male [53.9%]), of whom 2687 (20.8%) were Hispanic, 2891 (22.4%) were non-Hispanic Black, 5842 (45.3%) were non-Hispanic White, and 1489 (11.5%) were multiracial or of other race or ethnicity. A total of 6473 students (50.1%) were randomized to universal screening, and 6436 (49.9%) were randomized to targeted screening. Adolescents in the universal screening group had 5.92 times higher odds (95% CI, 5.07-6.93) of being identified with MDD symptoms, 3.30 times higher odds (95% CI, 2.49-4.38) of SAP confirming follow-up needs, and 2.07 times higher odds (95% CI, 1.39-3.10) of initiating MDD treatment. No differences were identified in initiation for planned subgroup analyses by sex or race and ethnicity.
Conclusions and Relevance


In this randomized clinical trial, universal school-based MDD screening successfully increased identification of MDD symptoms and treatment initiation among adolescents, confirming the value of this approach to address this rising public health concern.
Trial Registration


ClinicalTrials.gov identifier: NCT03716869.",2021,"Adolescents in the universal screening group had 5.92 times higher odds (95% CI, 5.07-6.93) of being identified with MDD symptoms, 3.30 times higher odds (95% CI, 2.49-4.38) of SAP confirming follow-up needs, and 2.07 times higher odds (95% CI, 1.39-3.10) of initiating MDD treatment.","['A total of 6473 students (50.1%) were randomized to universal screening, and 6436 (49.9', 'A total of 12\u202f909 students were included (median age, 16 years [range, 13-21 years]; 6963 male [53.9%]), of whom 2687 (20.8%) were Hispanic, 2891 (22.4%) were non-Hispanic Black, 5842 (45.3%) were non-Hispanic White, and 1489 (11.5%) were multiracial or of other race or ethnicity', 'Students within an identified school', 'November 6, 2018, to November 20, 2020, compared the usual school practice of targeted or selected screening based on observable behaviors of concern with universal MDD screening', 'Adolescents', 'students with behaviors prompting concern for MDD were referred to the Student Assistance Program (SAP), mandated in all Pennsylvania schools', 'Participants included students in grades 9 through 12 enrolled at 1 of the 14 participating Pennsylvania public high schools']",['universal adolescent MDD screening'],['initiation of MDD treatment or services based on data collected by school SAP teams during the academic year'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}]",12909.0,0.223978,"Adolescents in the universal screening group had 5.92 times higher odds (95% CI, 5.07-6.93) of being identified with MDD symptoms, 3.30 times higher odds (95% CI, 2.49-4.38) of SAP confirming follow-up needs, and 2.07 times higher odds (95% CI, 1.39-3.10) of initiating MDD treatment.","[{'ForeName': 'Deepa L', 'Initials': 'DL', 'LastName': 'Sekhar', 'Affiliation': 'Department of Pediatrics, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Schaefer', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Waxmonsky', 'Affiliation': 'Department of Psychiatry, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Leslie R', 'Initials': 'LR', 'LastName': 'Walker-Harding', 'Affiliation': ""Department of Pediatrics, Seattle Children's, Seattle, Washington.""}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Pattison', 'Affiliation': 'Department of Pediatrics, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Molinari', 'Affiliation': 'Department of Pediatrics, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Perri', 'Initials': 'P', 'LastName': 'Rosen', 'Affiliation': 'Statewide Project Advisor, Garrett Lee Smith Youth Suicide Prevention Grant, Harrisburg, Pennsylvania.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kraschnewski', 'Affiliation': 'Department of Pediatrics, Pennsylvania State College of Medicine, Hershey.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.31836']
2160,34734846,Effectiveness of Liquid Fasting with Yoga and Naturopathy Treatments in Reducing Metabolic and Cardiovascular Risks in Obesity.,"Context


Obesity is associated with chronic diseases, including metabolic syndrome and cardiovascular diseases (CVDs). Fasting is commonly employed by obese people to reduce their weight. Likewise, yoga and naturopathy (YN) that include liquid fasting (LF) have been shown to be beneficial in reducing weight for people with metabolic disorders. However, the safety of LF during YN treatments and its effects on metabolic and cardiovascular risk factors haven't yet been reported.
Objective


The study intended to evaluate the safety of LF during YN treatments and its effects on metabolic and cardiovascular risk factors in people with obesity.
Design


A single-group, pretest-and-posttest design was adopted for the study.
Setting


The study took place in a YN hospital located in South India.
Participants


Participants were 176 obese people aged between 18 and 65 years.
Intervention


Together with YN treatments, all participants underwent LF using lime juice with jaggery, ash guard juice, vegetable soup, buttermilk, and kokum juice for a period of 5 consecutive days.
Outcome Measures


Assessments such as body weight, body mass index (BMI), fat mass, lipid profile, and blood pressure were taken at baseline and postintervention.
Results


Participants showed a significant reduction in body weight, BMI, fat mass, triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), high-density lipoprotein cholesterol (HDL-C), systolic blood pressure (SBP), and diastolic blood pressure (DBP).
Conclusions


The results suggest that LF during YN treatment canbe effective in reducing metabolic and cardiovascular risk factors in people with obesity.",2021,"Results


Participants showed a significant reduction in body weight, BMI, fat mass, triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), high-density lipoprotein cholesterol (HDL-C), systolic blood pressure (SBP), and diastolic blood pressure (DBP).
","['YN hospital located in South India', 'people with obesity', 'people with metabolic disorders', 'Participants\n\n\nParticipants were 176 obese people aged between 18 and 65 years']","['Likewise, yoga and naturopathy (YN) that include liquid fasting (LF', 'Intervention\n\n\nTogether with YN treatments', 'Liquid Fasting with Yoga and Naturopathy Treatments', 'LF using lime juice with jaggery, ash guard juice, vegetable soup, buttermilk, and kokum juice']","['body weight, BMI, fat mass, triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), high-density lipoprotein cholesterol (HDL-C), systolic blood pressure (SBP), and diastolic blood pressure (DBP', 'metabolic and cardiovascular risk factors', 'Metabolic and Cardiovascular Risks in Obesity', 'body weight, body mass index (BMI), fat mass, lipid profile, and blood pressure']","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0027495', 'cui_str': 'Naturopathy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0027495', 'cui_str': 'Naturopathy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2697922', 'cui_str': 'LIME JUICE'}, {'cui': 'C0124291', 'cui_str': 'Jaggery'}, {'cui': 'C0994524', 'cui_str': 'Ash'}, {'cui': 'C0278253', 'cui_str': 'Guarded prognosis'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0453399', 'cui_str': 'Soup'}, {'cui': 'C0452719', 'cui_str': 'Buttermilk'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",176.0,0.0399198,"Results


Participants showed a significant reduction in body weight, BMI, fat mass, triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), high-density lipoprotein cholesterol (HDL-C), systolic blood pressure (SBP), and diastolic blood pressure (DBP).
","[{'ForeName': 'Swarna', 'Initials': 'S', 'LastName': 'Ganesh Iyyer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mooventhan', 'Affiliation': ''}, {'ForeName': 'Babina', 'Initials': 'B', 'LastName': 'Nandakumar', 'Affiliation': ''}]",Advances in mind-body medicine,[]
2161,34735839,Longitudinal relationship between maternal distress and pediatric mood symptoms in youth with mood disorders.,"Parents of a child with a mood disorder report significant levels of distress and burden from caregiving. This study examined whether maternal distress varies over time with levels of mood symptoms in youth with mood disorders, and whether expressed emotion (EE) and family functioning moderate these associations. We recruited youth (ages 9-17 years) with mood disorders and familial risk for bipolar disorder (BD) for a randomized trial of family-focused therapy compared to standard psychoeducation. Participants were assessed every 4-6 months for up to 4 years. Using repeated-measures mixed effects modeling, we examined the longitudinal effects of youths' mood symptoms and maternal distress concurrently, as well as whether each variable predicted the other in successive study intervals. Secondary analyses examined the moderating effects of EE and ratings of family cohesion and adaptability on maternal distress. In sample of 118 youth-mother dyads, levels of self-reported parental distress decreased over time, with no differences between treatment conditions. Youths' depressive symptoms and, most strongly, mood lability were associated with greater maternal distress longitudinally; however, maternal distress did not predict youths' mood symptoms or lability. The effect of youth symptoms on maternal distress was greater among mothers who were high EE. Family cohesion was associated with reduced concurrent ratings of maternal distress, whereas family adaptability was associated with reduced maternal distress at successive follow-ups. While maternal distress decreases over time as youths' symptoms decrease, mothers of youth with mood disorders experience significant distress that is directly linked to the youths' depressive symptom severity and lability. Improved family functioning appears to be an important mechanism by which to intervene.",2021,"Family cohesion was associated with reduced concurrent ratings of maternal distress, whereas family adaptability was associated with reduced maternal distress at successive follow-ups.","['youth with mood disorders', 'recruited youth (ages 9-17 years) with mood disorders and familial risk for bipolar disorder (BD', 'mothers who were high EE']",['standard psychoeducation'],"['distress and burden from caregiving', 'concurrent ratings of maternal distress', 'maternal distress', 'levels of self-reported parental distress', 'moderating effects of EE and ratings of family cohesion and adaptability on maternal distress']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0473485', 'cui_str': 'Maternal distress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",118.0,0.037101,"Family cohesion was associated with reduced concurrent ratings of maternal distress, whereas family adaptability was associated with reduced maternal distress at successive follow-ups.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA. Electronic address: mjweintraub@mednet.ucla.edu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private Practice, Menlo Park, CA, USA.'}, {'ForeName': 'Aimee E', 'Initials': 'AE', 'LastName': 'Sullivan', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.10.041']
2162,34735762,Sub-anesthetic intravenous ketamine vs. caudal bupivacaine for postoperative analgesia in children undergoing infra-umbilical surgeries: a non-inferiority randomized single-blind controlled trial.,"Background


Sub-anesthetic iv ketamine acts as an analgesic and has opioid-sparing effects, particularly for acute postoperative pain. Primary aim of this study was to evaluate the non-inferiority of sub-anesthetic iv ketamine vs caudal bupivacaine for postoperative analgesia in children.
Methods


Children below six years were enrolled in this single-blind study and randomized to receive either sub-anesthetic iv ketamine (0.3 mg/kg) or 1 ml/kg of caudal 0.125% bupivacaine, along with general anesthesia. Postoperative pain was assessed with the FLACC scale at 30 minutes, and at one, two, three, and six hours. Intra and postoperative opioid consumption, time to extubation, postoperative vomiting (POV), postoperative agitation, sedation, and inflammatory markers (serum IL-6 and TNF-α) were also assessed.
Results


One hundred and forty-one children completed the study, 71 in the ketamine and 70 in the caudal group. The cumulative proportion of children without significant postoperative pain (FLACC score < 4) until six hours post-surgery was 45.1% in the ketamine group vs 72.9% in the caudal group (P < 0.001). More children required an additional dose of intraoperative fentanyl (33.8% vs 5.7%; P < 0.001) and postoperative tramadol (54.9% vs. 27.1%; P < 0.001) in the ketamine group. Postoperative agitation, (4.3% vs. 9.9%; P = 0.19) and sedation (32.8% vs 22.5%; P = 0.17) were similar in the groups. Time to extubation, POV, baseline and post-surgical inflammatory markers were comparable.
Conclusions


Sub-anesthetic ketamine is inferior to caudal bupivacaine for postoperative analgesia in children below six years undergoing infra-umbilical surgeries but results in similar postoperative outcomes.",2021,"Postoperative agitation, (4.3% vs. 9.9%; P = 0.19) and sedation (32.8% vs 22.5%; P = 0.17) were similar in the groups.","['Methods\n\n\nChildren below six years', 'children undergoing infra-umbilical surgeries', 'children below six years undergoing infra-umbilical surgeries', 'One hundred and forty-one children completed the study, 71 in the ketamine and 70 in the caudal group', 'children']","['intraoperative fentanyl', 'sub-anesthetic iv ketamine (0.3 mg/kg) or 1 ml/kg of caudal 0.125% bupivacaine', 'ketamine vs caudal bupivacaine', 'ketamine vs. caudal bupivacaine', 'bupivacaine', 'ketamine']","['postoperative tramadol', 'Intra and postoperative opioid consumption, time to extubation, postoperative vomiting (POV), postoperative agitation, sedation, and inflammatory markers (serum IL-6 and TNF-α', 'Time to extubation, POV, baseline and post-surgical inflammatory markers', 'Postoperative agitation', 'Postoperative pain', 'sedation', 'cumulative proportion of children without significant postoperative pain (FLACC score < 4) until six hours post-surgery']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C4517427', 'cui_str': '0.125'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0520905', 'cui_str': 'Postoperative vomiting'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",141.0,0.448704,"Postoperative agitation, (4.3% vs. 9.9%; P = 0.19) and sedation (32.8% vs 22.5%; P = 0.17) were similar in the groups.","[{'ForeName': 'Alok Kumar', 'Initials': 'AK', 'LastName': 'Sahoo', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, All India Institute of Medical Sciences (AIIMS), Bhubaneswar.'}, {'ForeName': 'Satyajeet', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, All India Institute of Medical Sciences (AIIMS), Bhubaneswar.'}, {'ForeName': 'Bikram Kishore', 'Initials': 'BK', 'LastName': 'Behera', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, All India Institute of Medical Sciences (AIIMS), Bhubaneswar.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar.'}, {'ForeName': 'Sritam Swarup', 'Initials': 'SS', 'LastName': 'Jena', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, All India Institute of Medical Sciences (AIIMS), Bhubaneswar.'}, {'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Mohanty', 'Affiliation': 'Department of Pediatric Surgery, All India Institute of Medical Sciences (AIIMS), Bhubaneswar.'}]",Korean journal of anesthesiology,['10.4097/kja.21373']
2163,34736130,Outcomes of a single-arm implementation trial of extended-release subcutaneous buprenorphine depot injections in people with opioid dependence.,"BACKGROUND


Opioid agonist treatment (OAT) is an effective intervention for opioid dependence. Extended-release buprenorphine injections (BUP-XR) may have additional potential benefits over sublingual buprenorphine. This single-arm trial evaluated outcomes among people receiving 48 weeks of BUP-XR in diverse community healthcare settings in Australia, permitting examination of outcomes when BUP-XR is delivered in standard practice.
METHODS


Participants were recruited from a network of specialist public drug treatment services, primary care and some private practices in three states. Following a minimum 7 days on 8-32 mg of sublingual buprenorphine (±naloxone), participants received monthly subcutaneous BUP-XR injections administered by a healthcare practitioner and completed monthly research interviews. The primary endpoint was retention in treatment at 48 weeks.
FINDINGS


Participants (n = 100) were 28% women, mean age 44 years with a long history of OAT (median 5.8 years); heroin was the most common opioid of concern (58%). Treatment retention at 24 and 48 weeks was 86% and 75%, respectively. Participants with past-month injecting drug use (OR 0.23; 95%CI: 0.09-0.61) or heroin use (OR 0.23; 95%CI: 0.08-0.65) at baseline had lower odds of being retained in treatment to 48 weeks. Reductions in multiple forms of extra-medical drug use were observed. Improvements in quality of life, participation in employment, and treatment satisfaction measures were also observed.
INTERPRETATION


This real-world implementation study of BUP-XR demonstrated high retention and treatment satisfaction. This study provides important additional data on the uptake and experience of clients, with relevance for policy makers, health service planners, administrators, and practitioners.
FUNDING


Indivior.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03809143.",2021,Participants with past-month injecting drug use (OR 0.23; 95%CI: 0.09-0.61) or heroin use (OR 0.23; 95%CI: 0.08-0.65) at baseline had lower odds of being retained in treatment to 48 weeks.,"['people receiving 48 weeks of BUP-XR in diverse community healthcare settings in Australia', '100) were 28% women, mean age 44 years with a long history of OAT (median 5.8 years); heroin was the most common opioid of concern (58', 'Participants (n\xa0', 'Participants were recruited from a network of specialist public drug treatment services, primary care and some private practices in three states', 'people with opioid dependence']","['sublingual buprenorphine (±naloxone', 'Opioid agonist treatment (OAT', 'subcutaneous BUP-XR injections administered by a healthcare practitioner and completed monthly research interviews', 'buprenorphine', 'buprenorphine injections (BUP-XR', 'extended-release subcutaneous buprenorphine depot injections']","['Treatment retention', 'quality of life, participation in employment, and treatment satisfaction measures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0524662', 'cui_str': 'Opioid dependence'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4074542', 'cui_str': 'Buprenorphine Injection [Buprenex]'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",100.0,0.244468,Participants with past-month injecting drug use (OR 0.23; 95%CI: 0.09-0.61) or heroin use (OR 0.23; 95%CI: 0.08-0.65) at baseline had lower odds of being retained in treatment to 48 weeks.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia. Electronic address: michael.farrell@unsw.edu.au.'}, {'ForeName': 'Jeyran', 'Initials': 'J', 'LastName': 'Shahbazi', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia; The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Grebely', 'Affiliation': 'The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Discipline of Addiction Medicine, University of Sydney, Surry Hills, NSW, Australia; The Langton Centre, South East Sydney Local Health District, Surry Hills, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chambers', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Briony', 'Initials': 'B', 'LastName': 'Larance', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia; School of Psychology, University of Wollongong, Wollongong, NSW, Australia; Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ali', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia; Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia; Monash Addiction Research Centre and Eastern Health Clinical School, Monash University Peninsula Campus, Frankston, Victoria, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'Drug and Alcohol Services, Hunter New England Local Health District, Newcastle, NSW, Australia; Hunter Medical Research Institute, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Dore', 'Affiliation': 'The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McDonough', 'Affiliation': 'Drug and Alcohol Services South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Montebello', 'Affiliation': 'Discipline of Addiction Medicine, University of Sydney, Surry Hills, NSW, Australia; Drug and Alcohol Services, North Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nicholas', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Frankston Healthcare, Frankston, Victoria, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Rodgers', 'Affiliation': ""Rankin Court Treatment Centre, The O'Brien Centre, Darlinghurst, NSW, Australia.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Drug and Alcohol Clinical Advisory Service, Western Health, Victoria, Australia.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Degenhardt', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The International journal on drug policy,['10.1016/j.drugpo.2021.103492']
2164,34736575,Use of oral estradiol plus vaginal progesterone in healthy postmenopausal women.,"OBJECTIVES


To compare the effect of oral estradiol (E2) plus vaginal progesterone (P4) against placebo on endometrial thickness, endometrial biopsy pathology, cervical cytology and total cancer incidence among healthy postmenopausal women.
STUDY DESIGN


This study is a sub-analysis of the Early versus Late Intervention Trial with Estradiol (ELITE), a randomized, double-blinded, placebo-controlled trial that previously demonstrated that hormone therapy (HT) was associated with less progression of subclinical atherosclerosis than placebo when therapy was initiated within 6 years after menopause but not when it was initiated 10 or more years after menopause. This sub-analysis included only ELITE participants with an intact uterus, who were randomized to either daily oral micronized 17-beta-E2 1 mg/day with 4% vaginal micronized P4 gel 45 mg/day for 10 days each month or placebo.
MAIN OUTCOME MEASURES


Participants were evaluated at baseline and annually during a median follow-up of 4.8 years for endometrial thickness as determined by pelvic transvaginal ultrasound followed by an endometrial biopsy when indicated, and cervical cytology and cancer incidence.
RESULTS


Over up to 80 months of follow-up, participants randomized to oral E2 plus vaginal P4 had progressive and statistically significant increases in endometrial thickness (p<0.001), underwent more endometrial biopsies and had a higher rate of endometrial hyperplasia on endometrial biopsy compared with the placebo group. Due to the close follow-up of participants in the trial protocol, these abnormal findings were effectively treated.
CONCLUSION


Our results suggest that 10 days of vaginal P4 45 mg/day is insufficient to completely oppose the effect of oral E2 1 mg/day on the endometrium. Further studies are needed to test alternative doses or frequencies of administration of vaginal P4 for adequate endometrial protection from E2 therapy among postmenopausal women. ClinicalTrials.gov registration NCT00114517.",2021,"Over up to 80 months of follow-up, participants randomized to oral E2 plus vaginal P4 had progressive and statistically significant increases in endometrial thickness (p<0.001), underwent more endometrial biopsies and had a higher rate of endometrial hyperplasia on endometrial biopsy compared with the placebo group.","['healthy postmenopausal women', 'postmenopausal women', 'ELITE participants with an intact uterus']","['daily oral micronized 17-beta-E2 1 mg/day with 4% vaginal micronized P4 gel', 'oral estradiol plus vaginal progesterone', 'Estradiol (ELITE', 'hormone therapy (HT', 'placebo', 'oral estradiol (E2) plus vaginal progesterone (P4) against placebo', 'pelvic transvaginal ultrasound followed by an endometrial biopsy']","['progression of subclinical atherosclerosis', 'rate of endometrial hyperplasia on endometrial biopsy', 'endometrial thickness', 'endometrial thickness, endometrial biopsy pathology, cervical cytology and total cancer incidence']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0014173', 'cui_str': 'Endometrial hyperplasia'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0856201', 'cui_str': 'Cervical cytology'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.39254,"Over up to 80 months of follow-up, participants randomized to oral E2 plus vaginal P4 had progressive and statistically significant increases in endometrial thickness (p<0.001), underwent more endometrial biopsies and had a higher rate of endometrial hyperplasia on endometrial biopsy compared with the placebo group.","[{'ForeName': 'Intira', 'Initials': 'I', 'LastName': 'Sriprasert', 'Affiliation': 'Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. Electronic address: sriprase@usc.edu.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mert', 'Affiliation': 'Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shoupe', 'Affiliation': 'Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]",Maturitas,['10.1016/j.maturitas.2021.09.002']
2165,34699857,Functional outcomes with bright light in monotherapy and combined with fluoxetine in patients with major depressive disorder: Results from the LIFE-D trial.,"BACKGROUND


Bright light therapy has been shown to improve depressive symptoms in patients with nonseasonal major depressive disorder (MDD) but there are few studies examining functional outcomes.
METHODS


We examined secondary functional outcomes in the 8-week randomized, placebo-sham-controlled LIFE-D trial comparing light therapy, fluoxetine, and the combination in patients with nonseasonal MDD. Functional assessments included the Sheehan Disability Scale (SDS) and, for employed participants, the Lam Employment Absence and Productivity Scale (LEAPS). Analysis of covariance (ANCOVA) was conducted with SDS and LEAPS change scores from baseline to week 8 as dependent variables, treatment modality (light, fluoxetine) as an independent variable, and baseline SDS and LEAPS scores as covariates.
RESULTS


Of 122 randomized participants, SDS data were available for 105 and LEAPS data for 70. For the SDS, there were no interaction effects, but there was a significant small- to medium-sized main effect of light treatment on total SDS scores with corresponding significant effects in the Social Life and Family Life domains, but not in the Work/Study domain. There were no significant interaction or main effects with LEAPS scores.
CONCLUSION


Light therapy significantly improved social and family life functioning in patients with MDD. However, work functioning was not significantly improved despite large effect sizes; these results were limited by low statistical power because of small sample sizes. Future studies should use longer treatment durations and be powered to detect clinically relevant differences in functional outcomes.",2021,"For the SDS, there were no interaction effects, but there was a significant small- to medium-sized main effect of light treatment on total SDS scores with corresponding significant effects in the Social Life and Family Life domains, but not in the Work/Study domain.","['patients with MDD', 'patients with nonseasonal MDD', 'patients with nonseasonal major depressive disorder (MDD', '122 randomized participants', 'patients with major depressive disorder']","['placebo-sham-controlled LIFE-D trial comparing light therapy, fluoxetine', 'Light therapy', 'bright light in monotherapy and combined with fluoxetine']","['social and family life functioning', 'Sheehan Disability Scale (SDS) and, for employed participants, the Lam Employment Absence and Productivity Scale (LEAPS', 'depressive symptoms', 'Social Life and Family Life domains', 'total SDS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",122.0,0.0945963,"For the SDS, there were no interaction effects, but there was a significant small- to medium-sized main effect of light treatment on total SDS scores with corresponding significant effects in the Social Life and Family Life domains, but not in the Work/Study domain.","[{'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, University of British Columbia, 2255 Wesbrook Mall, Vancouver, BC V6T 2A1, Canada.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Morton', 'Affiliation': 'Department of Psychiatry, University of British Columbia, 2255 Wesbrook Mall, Vancouver, BC V6T 2A1, Canada.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Michalak', 'Affiliation': 'Department of Psychiatry, University of British Columbia, 2255 Wesbrook Mall, Vancouver, BC V6T 2A1, Canada.'}, {'ForeName': 'Edwin M', 'Initials': 'EM', 'LastName': 'Tam', 'Affiliation': 'Department of Psychiatry, University of British Columbia, 2255 Wesbrook Mall, Vancouver, BC V6T 2A1, Canada.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Levitt', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Levitan', 'Affiliation': 'Centre for Addictions and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cheung', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Morehouse', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Saint John, NB, Canada.'}, {'ForeName': 'Rajamannar', 'Initials': 'R', 'LastName': 'Ramasubbu', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, ON, Canada.'}, {'ForeName': 'Lakshmi N', 'Initials': 'LN', 'LastName': 'Yatham', 'Affiliation': 'Department of Psychiatry, University of British Columbia, 2255 Wesbrook Mall, Vancouver, BC V6T 2A1, Canada.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, University of British Columbia, 2255 Wesbrook Mall, Vancouver, BC V6T 2A1, Canada. Electronic address: r.lam@ubc.ca.'}]",Journal of affective disorders,['10.1016/j.jad.2021.10.035']
2166,34728476,Inhaled and intranasal ciclesonide for the treatment of covid-19 in adult outpatients: CONTAIN phase II randomised controlled trial.,"OBJECTIVE


To determine if inhaled and intranasal ciclesonide are superior to placebo at decreasing respiratory symptoms in adult outpatients with covid-19.
DESIGN


Randomised, double blind, placebo controlled trial.
SETTING


Three Canadian provinces (Quebec, Ontario, and British Columbia).
PARTICIPANTS


203 adults aged 18 years and older with polymerase chain reaction confirmed covid-19, presenting with fever, cough, or dyspnoea.
INTERVENTION


Participants were randomised to receive either inhaled ciclesonide (600 μg twice daily) and intranasal ciclesonide (200 μg daily) or metered dose inhaler and nasal saline placebos for 14 days.
MAIN OUTCOME MEASURES


The primary outcome was symptom resolution at day 7. Analyses were conducted on the modified intention-to-treat population (participants who took at least one dose of study drug and completed one follow-up survey) and adjusted for stratified randomisation by sex.
RESULTS


The modified intention-to-treat population included 203 participants: 105 were randomly assigned to ciclesonide (excluding two dropouts and one loss to follow-up) and 98 to placebo (excluding three dropouts and six losses to follow-up). The median age was 35 years (interquartile range 27-47 years) and 54% were women. The proportion of participants with resolution of symptoms by day 7 did not differ significantly between the intervention group (42/105, 40%) and control group (34/98, 35%); absolute adjusted risk difference 5.5% (95% confidence interval -7.8% to 18.8%). Results might be limited to the population studied, which mainly included younger adults without comorbidities. The trial was stopped early, therefore could have been underpowered.
CONCLUSION


Compared with placebo, the combination of inhaled and intranasal ciclesonide did not show a statistically significant increase in resolution of symptoms among healthier young adults with covid-19 presenting with prominent respiratory symptoms. As evidence is insufficient to determine the benefit of inhaled and intranasal corticosteroids in the treatment of covid-19, further research is needed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04435795.",2021,"The proportion of participants with resolution of symptoms by day 7 did not differ significantly between the intervention group (42/105, 40%) and control group (34/98, 35%); absolute adjusted risk difference 5.5% (95% confidence interval -7.8% to 18.8%).","['adult outpatients', 'The median age was 35 years (interquartile range 27-47 years) and 54% were women', '203 participants: 105', 'adult outpatients with covid-19', '203 adults aged 18 years and older with polymerase chain reaction confirmed covid-19, presenting with fever, cough, or dyspnoea', 'Three Canadian provinces (Quebec, Ontario, and British Columbia', 'healthier young adults with covid-19 presenting with prominent respiratory symptoms']","['ciclesonide', 'inhaled ciclesonide', 'placebo', 'Inhaled and intranasal ciclesonide', 'intranasal ciclesonide (200 μg daily) or metered dose inhaler and nasal saline placebos']","['respiratory symptoms', 'symptom resolution', 'resolution of symptoms', 'proportion of participants with resolution of symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}]","[{'cui': 'C0907850', 'cui_str': 'ciclesonide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",203.0,0.780773,"The proportion of participants with resolution of symptoms by day 7 did not differ significantly between the intervention group (42/105, 40%) and control group (34/98, 35%); absolute adjusted risk difference 5.5% (95% confidence interval -7.8% to 18.8%).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ezer', 'Affiliation': 'Department of Medicine, Division of Respirology, McGill University Health Centre, Montreal, Quebec, Canada nicole.ezer@mcgill.ca.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Belga', 'Affiliation': 'Division of Infectious Diseases, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Daneman', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, Division of Respirology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Shay-Anne', 'Initials': 'SA', 'LastName': 'Daniels', 'Affiliation': 'Division of Infectious Diseases, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Moran', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, Montreal, Quebec, Canada.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Besson', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Louisa Y', 'Initials': 'LY', 'LastName': 'Smyth', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Martin', 'Affiliation': 'Department of Medicine, Division of Respirology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}]",BMJ (Clinical research ed.),['10.1136/bmj-2021-068060']
2167,34728032,[Effect of the Seasonal Adaptability on Carbohydrate-electrolyte Beverage Efforts on Post-exercise Rehydration in Healthy Young Men].,"Objective To compare the effects of carbohydrate-electrolyte beverage on post-exercise rehydration of healthy young men in different seasons,and to explore the influence of seasonal adaptability on fluid and electrolyte balance.Methods Fifteen healthy men,aged(24.4±0.5)years,completed 2 trails in a random crossover design both in summer and winter.During recovery,they consumed a drink volume equivalent to 100% of their sweat loss with plain boiled water(the water group)or carbohydrate-electrolyte beverage(the beverage group).Recovery was monitored for further 180 minutes by the collection of blood and urine samples.Results The dehydration time in summer was significantly shorter by about 20 minutes than that in winter( t =3.045, P =0.004).In summer,the fluid retention rate of the beverage group was significantly higher than that of the water group at 120 minutes after rehydration [(83.7±2.8)%  vs. (73.7±3.7)%, F =5.312, P =0.028],and significantly higher than the water group at 180 minutes [(74.8±3.6)%  vs. (66.1±4.3)%, F =4.340, P =0.046].In winter,the fluid retention rate of the beverage group at 180 minutes after rehydration was significantly higher than that of the water group [(74.9±4.7)%  vs. (68.0±6.0)%, F =4.128, P =0.048].There was no significantly seasonal difference in the fluid retention effect of carbohydrate-electrolyte beverage at 180 minutes after rehydration.In the beverage group,the changes of blood glucose and serum sodium levels(all  P <0.05)in summer were significantly higher than those in winter at 10-180 minutes after rehydration,and the fractional excretion of sodium in summer was significantly higher in summer than in winter at 120 and 180 minutes after rehydration( F 120 =4.972, P =0.034; F 180 =8.425, P =0.007);however,there was no significant difference in plasma osmolality(all  P > 0.05).For the water group,the plasma osmolality in winter was lower than that in summer,while the degree of dryness and thirst was higher in winter than in summer.Conclusions Seasonal adaptability influenced the hydration status and its regulating factors.People dehydrated faster after exercise in summer than in winter,and the hydration status was relatively stable in winter.However,in summer,the blood glucose and electrolytes responded more rapidly to carbohydrate-electrolyte beverage supply,and the plasma osmolality and subjective perception recovered faster.Therefore,during the 180-minute recovery period,the carbohydrate-electrolyte beverage had a higher rehydration efficiency in a short recovery time in summer although there was no significantly seasonal difference in the fluid retention rate.",2021,"In the beverage group,the changes of blood glucose and serum sodium levels(all  P <0.05)in summer were significantly higher than those in winter at 10-180 minutes after rehydration,and the fractional excretion of sodium in summer was significantly higher in summer than in winter at 120 and 180 minutes after rehydration( F 120 =4.972, P =0.034; F 180 =8.425, P =0.007);however,there was no significant difference in plasma osmolality(all  P > 0.05).For the water group,the plasma osmolality in winter was lower than that in summer,while the degree of dryness and thirst was higher in winter than in summer.","['Healthy Young Men', 'Methods Fifteen healthy men,aged(24.4±0.5)years,completed 2 trails in a random crossover design both in summer and winter', 'healthy young men in different seasons']",['carbohydrate-electrolyte beverage'],"['fractional excretion of sodium in summer', 'blood glucose and electrolytes', 'rehydration efficiency', 'plasma osmolality', 'dehydration time in summer', 'fluid retention rate', 'changes of blood glucose and serum sodium levels(all  P <0.05)in summer', 'plasma osmolality and subjective perception', 'plasma osmolality(all']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0428601', 'cui_str': 'Measurement of fractional excretion of sodium'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0034997', 'cui_str': 'Rehydration therapy'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0268000', 'cui_str': 'Body fluid retention'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",15.0,0.0520594,"In the beverage group,the changes of blood glucose and serum sodium levels(all  P <0.05)in summer were significantly higher than those in winter at 10-180 minutes after rehydration,and the fractional excretion of sodium in summer was significantly higher in summer than in winter at 120 and 180 minutes after rehydration( F 120 =4.972, P =0.034; F 180 =8.425, P =0.007);however,there was no significant difference in plasma osmolality(all  P > 0.05).For the water group,the plasma osmolality in winter was lower than that in summer,while the degree of dryness and thirst was higher in winter than in summer.","[{'ForeName': 'Yi-Fan', 'Initials': 'YF', 'LastName': 'Wu', 'Affiliation': 'Beijing Key Laboratory of Sports Injuries,Institute of Sports Medicine of Peking University, Department of Sports Medicine,Peking University Third Hospital,Beijing 100191,China.'}, {'ForeName': 'Xian-Ren', 'Initials': 'XR', 'LastName': 'Huang', 'Affiliation': 'Beijing Key Laboratory of Sports Injuries,Institute of Sports Medicine of Peking University, Department of Sports Medicine,Peking University Third Hospital,Beijing 100191,China.'}, {'ForeName': 'Ying-Xiang', 'Initials': 'YX', 'LastName': 'Yu', 'Affiliation': 'Beijing Key Laboratory of Sports Injuries,Institute of Sports Medicine of Peking University, Department of Sports Medicine,Peking University Third Hospital,Beijing 100191,China.'}, {'ForeName': 'Cheng-Cheng', 'Initials': 'CC', 'LastName': 'Guo', 'Affiliation': 'Beijing Key Laboratory of Sports Injuries,Institute of Sports Medicine of Peking University, Department of Sports Medicine,Peking University Third Hospital,Beijing 100191,China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Beijing Key Laboratory of Sports Injuries,Institute of Sports Medicine of Peking University, Department of Sports Medicine,Peking University Third Hospital,Beijing 100191,China.'}, {'ForeName': 'Cui-Qing', 'Initials': 'CQ', 'LastName': 'Chang', 'Affiliation': 'Beijing Key Laboratory of Sports Injuries,Institute of Sports Medicine of Peking University, Department of Sports Medicine,Peking University Third Hospital,Beijing 100191,China.'}]",Zhongguo yi xue ke xue yuan xue bao. Acta Academiae Medicinae Sinicae,['10.3881/j.issn.1000-503X.13609']
2168,34735399,Comparison of four different methods of nasogastric tube insertion with double-lumen tracheal tube in situ: A randomised clinical trial.,,2021,,['situ'],['nasogastric tube insertion with double-lumen tracheal tube'],[],[],"[{'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube'}]",[],,0.266933,,"[{'ForeName': 'Satyajeet', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': 'From the Department of Anesthesiology & Critical Care, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.'}, {'ForeName': 'Bikram Kishore', 'Initials': 'BK', 'LastName': 'Behera', 'Affiliation': ''}, {'ForeName': 'Prasanta Kumar', 'Initials': 'PK', 'LastName': 'Das', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001471']
2169,34735395,Evaluation of antihyperalgesic and analgesic effects of 35% nitrous oxide when combined with remifentanil: A randomised phase 1 trial in volunteers.,"BACKGROUND


Remifentanil is an effective drug in peri-operative pain therapy, but it can also induce and aggravate hyperalgesia. Supplemental administration of N2O may help to reduce remifentanil-induced hyperalgesia.
OBJECTIVE


To evaluate the effect of 35 and 50% N2O on hyperalgesia and pain after remifentanil infusion.
DESIGN


Single site, phase 1, double-blind, placebo-controlled, randomised crossover study.
SETTING


University Hospital, Germany from January 2012 to April 2012.
PARTICIPANTS


Twenty-one healthy male volunteers.
INTERVENTIONS


Transcutaneous electrical stimulation induced spontaneous acute pain and stable areas of hyperalgesia. Each volunteer underwent the following four sessions in a randomised order: 50 to 50% N2-O2 and intravenous (i.v.) 0.9% saline infusion (placebo); 50 to 50% N2-O2 and i.v. remifentanil infusion at 0.1 μg kg-1 min-1 (remifentanil); 35 to 15 to 50% N2O-N2-O2 and i.v. remifentanil infusion at 0.1 μg kg-1 min-1 (tested drug) and 50 to 50% N2O-O2 and i.v. remifentanil infusion at 0.1 μg kg-1 min-1 (gas active control). Gas mixtures were inhaled for 60 min; i.v. drugs were administered for 30 min.
MAIN OUTCOME MEASURES


Areas of pin-prick hyperalgesia, areas of touch-evoked allodynia and pain intensity on a visual analogue scale were assessed repeatedly for 160 min.
RESULTS


Data from 20 volunteers were analysed. There were significant treatment and treatment-by-time effects regarding areas of hyperalgesia (P < 0.001). After the treatment period, the area of hyperalgesia was significantly reduced (P < 0.001) in the tested drug and in the gas active control (30.6 ± 9.25 and 24.4 ± 7.3 cm2, respectively) compared with remifentanil (51.0 ± 17.0 cm2). There was also a significant difference between the gas active control and the tested drug sessions (P < 0.001). For the area of allodynia and pain rating, results were consistent with the results for hyperalgesia.
CONCLUSIONS


Administration of 35% N2O significantly reduced hyperalgesia, allodynia and pain intensity induced after remifentanil. It might therefore be suitable in peri-operative pain relief characterised by hyperalgesia and allodynia, such as postoperative pain, and may help to reduce opioid demand.
TRIAL REGISTRATION


EudraCT-No.: 2011-000966-37.",2021,"After the treatment period, the area of hyperalgesia was significantly reduced (P < 0.001) in the tested drug and in the gas active control (30.6 ± 9.25 and 24.4 ± 7.3 cm2, respectively) compared with remifentanil (51.0 ± 17.0 cm2).","['volunteers', '20 volunteers were analysed', 'Twenty-one healthy male volunteers', 'University Hospital, Germany from January 2012 to April 2012']","['Transcutaneous electrical stimulation', '35% nitrous oxide', 'remifentanil infusion at 0.1 μg kg-1 min-1 (remifentanil', 'Remifentanil', 'saline infusion (placebo', 'placebo', 'remifentanil']","['area of hyperalgesia', 'spontaneous acute pain and stable areas of hyperalgesia', 'hyperalgesia and pain', 'allodynia and pain rating', 'hyperalgesia', 'hyperalgesia, allodynia and pain intensity', 'Areas of pin-prick hyperalgesia, areas of touch-evoked allodynia and pain intensity on a visual analogue scale']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",21.0,0.119408,"After the treatment period, the area of hyperalgesia was significantly reduced (P < 0.001) in the tested drug and in the gas active control (30.6 ± 9.25 and 24.4 ± 7.3 cm2, respectively) compared with remifentanil (51.0 ± 17.0 cm2).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wehrfritz', 'Affiliation': 'From the Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Department of Anaesthesiology (AW, HI, JP, JS), Department of Orthopaedic and Trauma Surgery, Erlangen, Germany (MB), Médical R&D, Air Liquide Santé International, Les Loges-en-Josas, France (NN, JFRG, BB).'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': ''}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Noel', 'Affiliation': ''}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ramirez-Gil', 'Affiliation': ''}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Ihmsen', 'Affiliation': ''}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Prottengeier', 'Affiliation': ''}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schüttler', 'Affiliation': ''}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Bessiere', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001468']
2170,34736073,Effects of a multicomponent intervention to slow mild cognitive impairment progression: A randomized controlled trial.,"BACKGROUND


Mild cognitive impairment affects 36% of people aged ≥65 years in China, around 50% of whom will develop dementia within 3 years. Early intervention can slow disease progression and delay the onset of dementia; however, whether a multicomponent intervention can decelerate the progression of mild cognitive impairment remains unknown.
OBJECTIVE


To evaluate the effects of a multicomponent intervention to slow mild cognitive impairment progression in Chinese patients.
DESIGN


Randomized controlled trial.
SETTING(S) AND PARTICIPANTS


This study was conducted in two large regional communities in Guangzhou, China. Patients aged ≥ 65 years diagnosed with mild cognitive impairment were included.
METHODS


A total of 112 eligible participants were assigned to receive either a 6-month multicomponent intervention or usual care from September 2019 until January 2021. Data were collected at the beginning of the study and at 1, 3, and 6 months thereafter. The primary outcomes were cognitive function, comprehensive physical capacity, depression, and quality of life. Analysis followed the intention-to-treat principle. A generalized estimating equation was used to determine intervention effects.
RESULTS


At baseline, clinical characteristics did not differ significantly between groups. Significant interaction effects between time and group were detected (p < 0.001), indicating that the scores of five outcomes (cognitive function, short physical performance battery, timed up and go test, quality of life, and depression) of intervention and control groups changed differently over time. Participants in the intervention group were found to have a significantly greater improvement in cognitive function, physical function, quality of life, and fewer depression symptoms compared with the control group at baseline and follow-up periods.
CONCLUSIONS


This study demonstrates the beneficial effects of a multicomponent intervention on cognitive function, physical function, depression symptoms, and quality of life in people with mild cognitive impairment in the East Asia region. The effectiveness and feasibility of this intervention program suggest that its application should be promoted in community settings to delay the progression of disease in people with mild cognitive impairment. Registration number:ChiCTR1900026042 Tweetable abstract: The multicomponent intervention improves cognitive/physical function, depression, and quality of life, slowing cognitive impairment progression.",2021,"Participants in the intervention group were found to have a significantly greater improvement in cognitive function, physical function, quality of life, and fewer depression symptoms compared with the control group at baseline and follow-up periods.
","['from September 2019 until January 2021', 'slow mild cognitive impairment progression', 'Patients aged ≥ 65 years diagnosed with mild cognitive impairment were included', 'Mild cognitive impairment affects 36% of people aged ≥65 years in China, around 50% of whom will develop dementia within 3 years', 'Registration number', 'people with mild cognitive impairment in the East Asia region', 'people with mild cognitive impairment', 'Chinese patients', 'two large regional communities in Guangzhou, China', 'A total of 112 eligible participants']","['multicomponent intervention', 'multicomponent intervention or usual care']","['scores of five outcomes (cognitive function, short physical performance battery, timed up and go test, quality of life, and depression', 'cognitive function, physical function, depression symptoms, and quality of life', 'cognitive function, comprehensive physical capacity, depression, and quality of life', 'cognitive function, physical function, quality of life, and fewer depression symptoms', 'cognitive/physical function, depression, and quality of life, slowing cognitive impairment progression']","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015631', 'cui_str': 'Far east country'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",112.0,0.109045,"Participants in the intervention group were found to have a significantly greater improvement in cognitive function, physical function, quality of life, and fewer depression symptoms compared with the control group at baseline and follow-up periods.
","[{'ForeName': 'Qiao-Hong', 'Initials': 'QH', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Jinan University, Guangzhou, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Lyu', 'Affiliation': ""Nursing Department, Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Qing-Ran', 'Initials': 'QR', 'LastName': 'Lin', 'Affiliation': 'Nursing Department, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Zi-Wen', 'Initials': 'ZW', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Jinan University, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, Jinan University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, Jinan University, Guangzhou, China.'}, {'ForeName': 'Qi-Yuan', 'Initials': 'QY', 'LastName': 'Lyu', 'Affiliation': 'School of Nursing, Jinan University, Guangzhou, China. Electronic address: yuanqlv@163.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2021.104110']
2171,34736504,Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial.,"BACKGROUND


Constipation is known as a common adverse effect of antipsychotics. Advice for its management remains inadequate. This study is designed to investigate the efficacy and safety of electro-acupuncture (EA) for antipsychotic-related constipation.
METHODS


This is a single-centric, parallel-group, randomized controlled trial with blinded participants, outcome assessor, and statistician. One hundred twelve participants will be randomly assigned into the EA group or sham acupuncture (SA) group in a 1:1 ratio. The study will last for 22 weeks for each participant, including a 2-week baseline assessment period, an 8-week treatment period, and a follow-up for 12 weeks. The primary outcome is the change of mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8 from baseline. Secondary outcomes include the change from baseline of mean weekly CSBMs during the follow-up period, mean weekly spontaneous bowel movements (SBMs), overall CSBM response rate, scores on Bristol Stool Form Scale (BSFS), straining level, Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of life questionnaire (PAC-QOL), and Brief Psychiatric Rating Scale (BPRS). Adverse events and medicine use will be recorded as well.
DISCUSSION


The study is designed based on a rigorous methodology to evaluate the efficacy and safety of EA for antipsychotic-related constipation. The finding will be published in peer-reviewed journals as reliable evidence.
TRIAL REGISTRATION


ClinicalTrials.gov ChiCTR2000032582. Registered May 3, 2020, with the Chinese Clinical Trial Registry.",2021,The primary outcome is the change of mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8 from baseline.,"['One hundred twelve participants', 'patients with antipsychotic-related constipation']","['EA group or sham acupuncture (SA', 'electro-acupuncture', 'EA', 'electro-acupuncture (EA']","['change from baseline of mean weekly CSBMs during the follow-up period, mean weekly spontaneous bowel movements (SBMs), overall CSBM response rate, scores on Bristol Stool Form Scale (BSFS), straining level, Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of life questionnaire (PAC-QOL), and Brief Psychiatric Rating Scale (BPRS', 'change of mean weekly complete spontaneous bowel movements (CSBMs']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}]",112.0,0.577147,The primary outcome is the change of mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8 from baseline.,"[{'ForeName': 'Fang-Ting', 'Initials': 'FT', 'LastName': 'Yu', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Di-He', 'Initials': 'DH', 'LastName': 'Long', 'Affiliation': 'Beijing Changping Hospital of Integrated Chinese and Western Medicine, Beijing, 102208, China.'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Gang', 'Affiliation': 'Beijing Changping Hospital of Integrated Chinese and Western Medicine, Beijing, 102208, China.'}, {'ForeName': 'Fu-Quan', 'Initials': 'FQ', 'LastName': 'Liu', 'Affiliation': 'Beijing Changping Hospital of Integrated Chinese and Western Medicine, Beijing, 102208, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Beijing Changping Hospital of Integrated Chinese and Western Medicine, Beijing, 102208, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Beijing Changping Hospital of Integrated Chinese and Western Medicine, Beijing, 102208, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Bao', 'Affiliation': 'Beijing Changping Hospital of Integrated Chinese and Western Medicine, Beijing, 102208, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Beijing Changping Hospital of Integrated Chinese and Western Medicine, Beijing, 102208, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Beijing Changping Hospital of Integrated Chinese and Western Medicine, Beijing, 102208, China.'}, {'ForeName': 'Shi-Yan', 'Initials': 'SY', 'LastName': 'Yan', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China. yanshiyan0927@sina.com.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China. yangjw0626@126.com.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.'}]",Trials,['10.1186/s13063-021-05732-5']
2172,34736499,"Gastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase II randomized controlled trial.","Androgen deprivation therapy (ADT) used for prostate cancer (PCa) management is associated with metabolic and anthropometric toxicity. Metformin given concurrent to ADT is hypothesized to counteract these changes. This planned interim analysis reports the gastrointestinal and genitourinary toxicity profiles of PCa patients receiving ADT and prostate/pelvic radiotherapy plus metformin versus placebo as part of a phase 2 randomized controlled trial. Men with intermediate or high-risk PCa were randomized 1:1 to metformin versus placebo. Both groups were given ADT for 18-36 months with minimum 2-month neoadjuvant phase prior to radiotherapy. Acute gastrointestinal and genitourinary toxicities were quantified using CTCAE v4.0. Differences in ≥ grade 2 toxicities by treatment were assessed by chi-squared test. 83 patients were enrolled with 44 patients randomized to placebo and 39 randomized to metformin. There were no significant differences at any time point in ≥ grade 2 gastrointestinal toxicities or overall gastrointestinal toxicity. Overall ≥ grade 2 gastrointestinal toxicity was low prior to radiotherapy (7.9% (placebo) vs. 3.1% (metformin), p = 0.39) and at the end of radiotherapy (2.8% (placebo) vs 3.1% (metformin), p = 0.64). There were no differences in overall ≥ grade 2 genitourinary toxicity between treatment arms (19.0% (placebo) vs. 9.4% (metformin), p = 0.30). Metformin added to radiotherapy and ADT did not increase rates of ≥ grade 2 gastrointestinal or genitourinary toxicity and is generally safe and well-tolerated.",2021,Metformin added to radiotherapy and ADT did not increase rates of ≥ grade 2 gastrointestinal or genitourinary toxicity and is generally safe and well-tolerated.,"['83 patients were enrolled with 44 patients randomized to', 'PCa patients receiving ADT and prostate/pelvic', 'Men with intermediate or high-risk PCa', 'men with prostate cancer receiving prostate radiotherapy']","['Androgen deprivation therapy (ADT', 'radiotherapy plus metformin', 'placebo', 'Metformin', 'radiotherapy and ADT', 'metformin versus placebo', 'metformin']","['Acute gastrointestinal and genitourinary toxicities', 'overall\u2009≥\u2009grade 2 genitourinary toxicity', 'rates of\u2009≥\u2009grade 2 gastrointestinal or genitourinary toxicity', 'safe and well-tolerated', 'Gastrointestinal and genitourinary toxicity profiles', 'Overall\u2009≥\u2009grade 2 gastrointestinal toxicity', 'time point in\u2009≥\u2009grade 2 gastrointestinal toxicities or overall gastrointestinal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",83.0,0.241466,Metformin added to radiotherapy and ADT did not increase rates of ≥ grade 2 gastrointestinal or genitourinary toxicity and is generally safe and well-tolerated.,"[{'ForeName': 'Julian O', 'Initials': 'JO', 'LastName': 'Kim', 'Affiliation': 'Radiation Oncology, Department of Radiology, Max Rady Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada. jkim7@cancercare.mb.ca.'}, {'ForeName': 'Megan O', 'Initials': 'MO', 'LastName': 'McDonald', 'Affiliation': 'Postgraduate Medical Education, Max Rady Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Aldrich', 'Initials': 'A', 'LastName': 'Ong', 'Affiliation': 'Radiation Oncology, Department of Radiology, Max Rady Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Koul', 'Affiliation': 'Radiation Oncology, Department of Radiology, Max Rady Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Arbind', 'Initials': 'A', 'LastName': 'Dubey', 'Affiliation': 'Radiation Oncology, Department of Radiology, Max Rady Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hunter', 'Affiliation': 'Radiation Oncology, Department of Radiology, Max Rady Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Shahida', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Radiation Oncology, Department of Radiology, Max Rady Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Yee', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Parliament', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Gokulan', 'Initials': 'G', 'LastName': 'Sivananthan', 'Affiliation': 'Radiation Oncology, Department of Radiology, Max Rady Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Brita', 'Initials': 'B', 'LastName': 'Danielson', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Rowe', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Nawaid', 'Initials': 'N', 'LastName': 'Usmani', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}]","Radiation oncology (London, England)",['10.1186/s13014-021-01935-x']
2173,34736498,The design of a Bayesian adaptive clinical trial of tranexamic acid in severely injured children.,"BACKGROUND


Trauma is the leading cause of death and disability in children in the USA. Tranexamic acid (TXA) reduces the blood transfusion requirements in adults and children during surgery. Several studies have evaluated TXA in adults with hemorrhagic trauma, but no randomized controlled trials have occurred in children with trauma. We propose a Bayesian adaptive clinical trial to investigate TXA in children with brain and/or torso hemorrhagic trauma.
METHODS/DESIGN


We designed a double-blind, Bayesian adaptive clinical trial that will enroll up to 2000 patients. We extend the traditional E max  dose-response model to incorporate a hierarchical structure so multiple doses of TXA can be evaluated in different injury populations (isolated head injury, isolated torso injury, or both head and torso injury). Up to 3 doses of TXA (15 mg/kg, 30 mg/kg, and 45 mg/kg bolus doses) will be compared to placebo. Equal allocation between placebo, 15 mg/kg, and 30 mg/kg will be used for an initial period within each injury group. Depending on the dose-response curve, the 45 mg/kg arm may open in an injury group if there is a trend towards increasing efficacy based on the observed relationship using the data from the lower doses. Response-adaptive randomization allows each injury group to differ in allocation proportions of TXA so an optimal dose can be identified for each injury group. Frequent interim stopping periods are included to evaluate efficacy and futility. The statistical design is evaluated through extensive simulations to determine the operating characteristics in several plausible scenarios. This trial achieves adequate power in each injury group.
DISCUSSION


This trial design evaluating TXA in pediatric hemorrhagic trauma allows for three separate injury populations to be analyzed and compared within a single study framework. Individual conclusions regarding optimal dosing of TXA can be made within each injury group. Identifying the optimal dose of TXA, if any, for various injury types in childhood may reduce death and disability.",2021,Response-adaptive randomization allows each injury group to differ in allocation proportions of TXA so an optimal dose can be identified for each injury group.,"['adults with hemorrhagic trauma', 'children with trauma', '2000 patients', 'severely injured children', 'adults and children during surgery', 'children in the USA', 'children with brain and/or torso hemorrhagic trauma']","['TXA', 'placebo', 'tranexamic acid', 'Tranexamic acid (TXA']",['blood transfusion requirements'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",,0.286079,Response-adaptive randomization allows each injury group to differ in allocation proportions of TXA so an optimal dose can be identified for each injury group.,"[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'VanBuren', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT, 84108, USA. john.vanburen@hsc.utah.edu.'}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT, 84108, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Nishijima', 'Affiliation': 'Department of Emergency Medicine, University of California, Davis School of Medicine, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Emergency Medicine, University of California, Davis School of Medicine, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, CA, 90509, USA.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT, 84108, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGlothlin', 'Affiliation': 'Berry Consultants, LLC, Austin, TX, 78746, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-021-05737-0']
2174,34736535,Effect of exercise and diet intervention in NAFLD and NASH via GAB2 methylation.,"BACKGROUND


Nonalcoholic fatty liver disease (NAFLD) is a disorder that extends from simple hepatic steatosis to nonalcoholic steatohepatitis (NASH), which is effectively alleviated by lifestyle intervention. Nevertheless, DNA methylation mechanism underling the effect of environmental factors on NAFLD and NASH is still obscure. The aim of this study was to investigate the effect of exercise and diet intervention in NAFLD and NASH via DNA methylation of GAB2.
METHODS


Methylation of genomic DNA in human NAFLD was quantified using Infinium Methylation EPIC BeadChip assay after exercise (Ex), low carbohydrate diet (LCD) and exercise plus low carbohydrate diet (ELCD) intervention. The output Idat files were processed using ChAMP package. False discovery rate on genome-wide analysis of DNA methylation (q < 0.05), and cytosine-guanine dinucleotides (CpGs) which are located in promoters were used for subsequent analysis (|Δβ|≥ 0.1). K-means clustering was used to cluster differentially methylated genes according to 3D genome information from Human embryonic stem cell. To quantify DNA methylation and mRNA expression of GRB2 associated binding protein 2 (GAB2) in NASH mice after Ex, low fat diet (LFD) and exercise plus low fat diet (ELFD), MassARRAY EpiTYPER and quantitative reverse transcription polymerase chain reaction were used.
RESULTS


Both LCD and ELCD intervention on human NAFLD can induce same DNA methylation alterations at critical genes in blood, e.g., GAB2, which was also validated in liver and adipose of NASH mice after LFD and ELFD intervention. Moreover, methylation of CpG units (i.e., CpG_10.11.12) inversely correlated with mRNA expression GAB2 in adipose tissue of NASH mice after ELFD intervention.
CONCLUSIONS


We highlighted the susceptibility of DNA methylation in GAB2 to ELFD intervention, through which exercise and diet can protect against the progression of NAFLD and NASH on the genome level, and demonstrated that the DNA methylation variation in blood could mirror epigenetic signatures in target tissues of important biological function, i.e., liver and adipose tissue. Trial registration International Standard Randomized Controlled Trial Number Register (ISRCTN 42622771).",2021,"False discovery rate on genome-wide analysis of DNA methylation (q < 0.05), and cytosine-guanine dinucleotides (CpGs) which are located in promoters were used for subsequent analysis (|Δβ|≥ 0.1).",['Methylation of genomic DNA in human NAFLD'],"['Infinium Methylation EPIC BeadChip assay after exercise (Ex), low carbohydrate diet (LCD) and exercise plus low carbohydrate diet (ELCD) intervention', 'LCD and ELCD intervention', 'low fat diet (LFD) and exercise plus low fat diet (ELFD), MassARRAY EpiTYPER and quantitative reverse transcription polymerase chain reaction', 'exercise and diet intervention']",[],"[{'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",[],,0.0224223,"False discovery rate on genome-wide analysis of DNA methylation (q < 0.05), and cytosine-guanine dinucleotides (CpGs) which are located in promoters were used for subsequent analysis (|Δβ|≥ 0.1).","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Shanghai Innovation Center of Traditional Chinese Medicine Health Service, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Fengyan', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Innovation Center of Traditional Chinese Medicine Health Service, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Decheng', 'Initials': 'D', 'LastName': 'Ren', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Liangjie', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Zhenming', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Mofan', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Su', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Fengping', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China.'}, {'ForeName': 'Ruirui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Shanghai Innovation Center of Traditional Chinese Medicine Health Service, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Baocheng', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Shanghai Innovation Center of Traditional Chinese Medicine Health Service, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Shenglong', 'Initials': 'S', 'LastName': 'Le', 'Affiliation': 'Exercise Translational Medicine Center, Shanghai Center for Systems Biomedicine, Shanghai Jiao Tong University, Shanghai, China. longsonlok@163.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China. yishi@sjtu.edu.cn.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'He', 'Affiliation': 'Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, 1954 Huashan Road, Shanghai, 200030, China. heguangbiox@163.com.'}]",Cell & bioscience,['10.1186/s13578-021-00701-6']
2175,34736509,Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer: the BULLSEYE trial.,"BACKGROUND


The BULLSEYE trial is a multicenter, open-label, randomized controlled trial to test the hypothesis if  177 Lu-PSMA is an effective treatment in oligometastatic hormone-sensitive prostate cancer (oHSPC) to prolong the progression-free survival (PFS) and postpone the need for androgen deprivation therapy (ADT). The original study protocol was published in 2020. Here, we report amendments that have been made to the study protocol since the commencement of the trial.
CHANGES IN METHODS AND MATERIALS


Two important changes were made to the original protocol: (1) the study will now use  177 Lu-PSMA-617 instead of  177 Lu-PSMA-I&T and (2) responding patients with residual disease on  18 F-PSMA PET after the first two cycles are eligible to receive additional two cycles of 7.4 GBq  177 Lu-PSMA in weeks 12 and 18, summing up to a maximum of 4 cycles if indicated. Therefore, patients receiving  177 Lu-PSMA-617 will also receive an interim  18 F-PSMA PET scan in week 4 after cycle 2. The title of this study was modified to; ""Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer"" and is now partly supported by Advanced Accelerator Applications, a Novartis Company.
CONCLUSIONS


We present an update of the original study protocol prior to the completion of the study. Treatment arm patients that were included and received  177 Lu-PSMA-I&T under the previous protocol will be replaced.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04443062 . First posted: June 23, 2020.",2021,"Treatment arm patients that were included and received  177 Lu-PSMA-I&T under the previous protocol will be replaced.
","['Two important changes were made to the original protocol: (1) the study will now use  177 Lu-PSMA-617 instead of  177 Lu-PSMA-I&T and (2) responding patients with residual disease on  18 F-PSMA PET after the first two cycles are eligible', 'Oligo-metastatic hormone-sensitive prostate cancer']",['lutetium-177-PSMA'],[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C4078835', 'cui_str': 'PSMA-617'}, {'cui': 'C4505917', 'cui_str': '68Ga-DOTAGA-(3-iodo-y)fk(Sub-KuE)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0302995', 'cui_str': 'Fluorine-18'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0028953', 'cui_str': 'Oligonucleotide'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}]",[],,0.481421,"Treatment arm patients that were included and received  177 Lu-PSMA-I&T under the previous protocol will be replaced.
","[{'ForeName': 'Bastiaan M', 'Initials': 'BM', 'LastName': 'Privé', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Marcel J R', 'Initials': 'MJR', 'LastName': 'Janssen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'van Oort', 'Affiliation': 'Department of Urology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Constantijn H J', 'Initials': 'CHJ', 'LastName': 'Muselaers', 'Affiliation': 'Department of Urology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Marianne A', 'Initials': 'MA', 'LastName': 'Jonker', 'Affiliation': 'Department of Health Evidence, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Willemijn A', 'Initials': 'WA', 'LastName': 'van Gemert', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'de Groot', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'Westdorp', 'Affiliation': 'Department of Medical Oncology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Niven', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': 'Department of Medical Oncology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'J Fred', 'Initials': 'JF', 'LastName': 'Verzijlbergen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Tom W J', 'Initials': 'TWJ', 'LastName': 'Scheenen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Zámecnik', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Jelle O', 'Initials': 'JO', 'LastName': 'Barentsz', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gotthardt', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Noordzij', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wouter V', 'Initials': 'WV', 'LastName': 'Vogel', 'Affiliation': 'Department of Radiology and Nuclear Medicine, NKI Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Andries M', 'Initials': 'AM', 'LastName': 'Bergman', 'Affiliation': 'Department of Medical Oncology, NKI Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk G', 'Initials': 'HG', 'LastName': 'van der Poel', 'Affiliation': 'Department of Urology, NKI Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'André N', 'Initials': 'AN', 'LastName': 'Vis', 'Affiliation': 'Department of Urology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniela E', 'Initials': 'DE', 'LastName': 'Oprea-Lager', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Winald R', 'Initials': 'WR', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Medical Oncology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'J Alfred', 'Initials': 'JA', 'LastName': 'Witjes', 'Affiliation': 'Department of Urology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nagarajah', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands. james.nagarajah@radboudumc.nl.'}]",Trials,['10.1186/s13063-021-05733-4']
2176,34737470,"Iron and folic acid consumption and changing social norms: cluster randomized field trial, Odisha, India.","Objective


To assess whether improvements in social norms related to iron and folic acid consumption are associated with increased iron and folic acid consumption.
Methods


In a cluster randomized trial in Odisha, India, we implemented an intervention to improve descriptive norms (people's perceptions about how many other people take iron and folic acid), injunctive norms (social pressures people feel to take iron and folic acid) and collective norms (actual levels of iron and folic acid consumption). We assessed changes in these norms and self-reported iron and folic acid consumption in control and intervention arms after 6 months (September 2019-February 2020). We collected data from control ( n  = 2048) and intervention ( n  = 2060) arms at baseline and follow-up ( n  = 1966 and  n  = 1987, respectively).
Findings


At follow-up, mean scores in self-reported iron and folic acid consumption in the control arm had decreased from 0.39 to 0.31 (21% decrease; not significant). In the intervention arm, mean scores increased from 0.39 to 1.62 (315% increase;  P  < 0.001). The difference between the two arms was statistically significant ( P  < 0.001). Each of the three norms also improved at significantly higher rates in the intervention than in the control arm ( P  < 0.001 for each norm). Changes in descriptive and collective norms (but not injunctive norms) were associated with changes in self-reported iron and folic acid consumption ( P  < 0.001 for both norms).
Conclusion


Our results show that social norms can be improved and that these improvements are associated with positive behavioural changes. A social norms-based approach may help promote iron and folic acid consumption in India.",2021,Each of the three norms also improved at significantly higher rates in the intervention than in the control arm ( P  < 0.001 for each norm).,[],"['Iron and folic acid consumption', 'people take iron and folic acid), injunctive norms (social pressures people feel to take iron and folic acid) and collective norms (actual levels of iron and folic acid consumption']","['changes in self-reported iron and folic acid consumption', 'mean scores', 'mean scores in self-reported iron and folic acid consumption']",[],"[{'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0472199,Each of the three norms also improved at significantly higher rates in the intervention than in the control arm ( P  < 0.001 for each norm).,"[{'ForeName': 'Rajiv N', 'Initials': 'RN', 'LastName': 'Rimal', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins University, 624 N Broadway, Baltimore, MD 21205, United States of America (USA).'}, {'ForeName': 'Hagere', 'Initials': 'H', 'LastName': 'Yilma', 'Affiliation': 'Department of Prevention and Community Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sedlander', 'Affiliation': 'Department of Family and Community Medicine, University of California San Francisco, San Francisco, USA.'}, {'ForeName': 'Satyanarayan', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'DCOR Consulting, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Patro', 'Affiliation': 'IPE-Global, New Delhi, India.'}, {'ForeName': 'Ichhya', 'Initials': 'I', 'LastName': 'Pant', 'Affiliation': 'Department of Prevention and Community Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Srimant K', 'Initials': 'SK', 'LastName': 'Khuntia', 'Affiliation': 'IPE-Global, New Delhi, India.'}, {'ForeName': 'Minati', 'Initials': 'M', 'LastName': 'Swain', 'Affiliation': 'DCOR Consulting, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Satyaranjan', 'Initials': 'S', 'LastName': 'Behera', 'Affiliation': 'DCOR Consulting, Bhubaneswar, Odisha, India.'}]",Bulletin of the World Health Organization,['10.2471/BLT.20.278820']
2177,34737364,Tryptophan-enriched diet or 5-hydroxytryptophan supplementation given in a randomized controlled trial impacts social cognition on a neural and behavioral level.,"Understanding of emotions and intentions are key processes in social cognition at which serotonin is an important neuromodulator. Its precursor is the essential amino acid tryptophan (TRP). Reduced TRP availability leads to weaker impulse control ability and higher aggression, while TRP supplementation promotes confidence. In a double-blind placebo-controlled fMRI study with 77 healthy adults, we investigated the influence of a 4 week TRP enriched diet and an acute 5-hydroxytryptophan (5-HTP) intake on two social-cognitive tasks, a moral evaluation and an emotion recognition task. With 5-HTP, immoral behavior without negative consequences was rated as more reprehensible. Additionally, during story reading, activation in insula and supramarginal gyrus was increased after TRP intake. No significant effects of TRP on emotion recognition were identified for the whole sample. Importantly, emotion recognition ability decreased with age which was for positive emotions compensated by TRP. Since the supramarginal gyrus is associated with empathy, pain and related information integration results could be interpreted as reflecting stricter evaluation of negative behavior due to better integration of information. Improved recognition of positive emotions with TRP in older participants supports the use of a TRP-rich diet to compensate for age related decline in social-cognitive processes.",2021,"Additionally, during story reading, activation in insula and supramarginal gyrus was increased after TRP intake.","['77 healthy adults', 'older participants']","['placebo', 'Tryptophan-enriched diet or 5-hydroxytryptophan supplementation', 'TRP enriched diet and an acute 5-hydroxytryptophan']","['story reading, activation in insula and supramarginal gyrus', 'emotion recognition ability', 'TRP on emotion recognition']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0228214', 'cui_str': 'Structure of supramarginal gyrus'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}]",77.0,0.0679568,"Additionally, during story reading, activation in insula and supramarginal gyrus was increased after TRP intake.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Zamoscik', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, J 5, 68159, Mannheim, Germany. Vera.Zamoscik@ZI-Mannheim.de.'}, {'ForeName': 'S N L', 'Initials': 'SNL', 'LastName': 'Schmidt', 'Affiliation': 'Research Group of Clinical Psychology, Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bravo', 'Affiliation': 'Chrononutrition Laboratory, Neuroimmunephysiology and Chrononutrition Research Group, Faculty of Science, University of Extremadura, Badajoz, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ugartemendia', 'Affiliation': 'Chrononutrition Laboratory, Neuroimmunephysiology and Chrononutrition Research Group, Faculty of Science, University of Extremadura, Badajoz, Spain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Plieger', 'Affiliation': 'Department of Psychology, Laboratory of Neurogenetics, University of Bonn, Bonn, Germany.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Rodríguez', 'Affiliation': 'Chrononutrition Laboratory, Neuroimmunephysiology and Chrononutrition Research Group, Faculty of Science, University of Extremadura, Badajoz, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reuter', 'Affiliation': 'Department of Psychology, Laboratory of Neurogenetics, University of Bonn, Bonn, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kirsch', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, J 5, 68159, Mannheim, Germany.'}]",Scientific reports,['10.1038/s41598-021-01164-y']
2178,34740056,Young adults perceive small disturbances to their walking balance even when distracted.,"BACKGROUND


The ability to perceive disturbances to ongoing locomotion (e.g., slips and trips) may play an important role in walking balance control. However, how well young adults can perceive such disturbances is unknown.
RESEARCH QUESTION


The purpose of this study was to identify the perception threshold in young adults to subtle slip-like locomotor disturbances.
METHODS


Subjects (n = 12) walked on a split-belt treadmill performing a perturbation discrimination task at their preferred walking speed while randomly experiencing locomotor balance disturbances every 8-12 strides. Balance disturbances were imposed through a short-duration decrease in velocity of a single treadmill belt triggered at heel-strike. The treadmill belt returned to the subject's preferred walking speed during the subsequent swing phase. Locomotor disturbances were given with eight different velocity changes ranging from 0 to 0.4 m/s and were randomized and repeated 5 times. Subjects were prompted to respond when asked if they perceived each disturbance. Using a psychophysical approach, we determined the perception thresholds of slip-like locomotor disturbances (i.e., just noticeable difference). The perturbation discrimination task was repeated with subjects performing a secondary cognitive distraction (counting backward by threes).
RESULTS


Subjects perceived small locomotor disturbances during both normal walking (dominant: 0.07 ± 0.03 m/s, non-dominant: 0.08 ± 0.03 m/s) and while performing the secondary cognitive task (dominant: 0.08 ± 0.01 m/s, non-dominant: 0.09 ± 0.02 m/s). There was no significant difference between legs (p = 0.466), with the addition of the cognitive task (p = 0.08), or interaction between leg and task (p = 0.994).
SIGNIFICANCE


The ability to perceive subtle slip-like locomotor disturbances was maintained even when performing a cognitively distracting task, suggesting that young adults can perceive very small locomotor disturbances.",2021,"There was no significant difference between legs (p = 0.466), with the addition of the cognitive task (p = 0.08), or interaction between leg and task (p = 0.994).
","['Young adults', 'young adults to subtle slip-like locomotor disturbances', 'Subjects (n\xa0=\xa012) walked on a']","['perturbation discrimination task was repeated with subjects performing a secondary cognitive distraction (counting backward by threes', 'split-belt treadmill performing a perturbation discrimination task at their preferred walking speed while randomly experiencing locomotor balance disturbances every 8-12 strides']","['Locomotor disturbances', 'Balance disturbances', 'small locomotor disturbances']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0205449', 'cui_str': '3'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1720374', 'cui_str': 'Every'}]","[{'cui': 'C1744587', 'cui_str': 'Difficulty balancing'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",12.0,0.0212636,"There was no significant difference between legs (p = 0.466), with the addition of the cognitive task (p = 0.08), or interaction between leg and task (p = 0.994).
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Liss', 'Affiliation': 'Department of Chemical and Biomedical Engineering, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Hannah D', 'Initials': 'HD', 'LastName': 'Carey', 'Affiliation': 'Department of Chemical and Biomedical Engineering, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Sergiy', 'Initials': 'S', 'LastName': 'Yakovenko', 'Affiliation': 'Department of Exercise Physiology, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Allen', 'Affiliation': 'Department of Chemical and Biomedical Engineering, West Virginia University, Morgantown, WV, USA. Electronic address: Jessica.allen@mail.wvu.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2021.10.019']
2179,34740020,HCV communication within ego-centric networks of men and women who inject drugs.,"INTRODUCTION


Leveraging interpersonal communication among social networks of people who inject drugs (PWID) may be an innovative strategy to increase awareness and access to hepatitis C (HCV) care. However, little is known about HCV communication patterns among PWID and if these patterns vary by gender.
METHODS


Egocentric network data collected at baseline from HCV-infected PWID enrolled in a randomized HCV treatment intervention trial in Baltimore, Maryland were analyzed. Logistic generalized estimating models were conducted to identify predictors of HCV communication.
RESULTS


Among 227 PWID, the mean age was 43.8 (SD=10.3), 28.2% (n = 64) were women and 71.8% (n = 163) were men. Female participants reported 516 dyadic relationships and male participants 1139 dyadic relationships. While there were significant gender differences based on socio-demographics, risk behavior and network composition, there were few differences in HCV communication patterns. Both men and women had increased odds of HCV communication with alters who are currently enrolled in drug treatment (AOR 1.7, 95% CI: 1.3-2.4), alters with whom participants share drug preparation equipment (AOR 3.0, 95% CI: 1.9-4.6), alters who are sex partners compared to kin (AOR 3.0; 95% CI: 1.9-4.9) and alters with whom respondents have increased trust (AOR 1.1; 95% CI: 1.11.2) and daily/weekly interactions (AOR 1.7; 95% CI 1.3-2.1).
CONCLUSION


PWID engaged with trusted alters about HCV disclosure and information, highlighting the important role network interventions could play in this vulnerable population.",2021,"Both men and women had increased odds of HCV communication with alters who are currently enrolled in drug treatment (AOR 1.7, 95% CI: 1.3-2.4), alters with whom participants share drug preparation equipment (AOR 3.0, 95% CI: 1.9-4.6), alters who are sex partners compared to kin (AOR 3.0; 95% CI: 1.9-4.9) and alters with whom respondents have increased trust (AOR 1.1; 95% CI: 1.11.2) and daily/weekly interactions (AOR 1.7; 95% CI 1.3-2.1).
","['n\xa0=\xa064) were women and 71.8% ', 'n\xa0=\xa0163) were men', 'Egocentric network data collected at baseline from HCV-infected PWID enrolled in a randomized HCV treatment intervention trial in Baltimore, Maryland were analyzed', 'people who inject drugs (PWID', 'Female participants reported 516 dyadic relationships and male participants 1139 dyadic relationships', 'men and women who inject drugs']",[],"['HCV communication', 'socio-demographics, risk behavior and network composition']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",1139.0,0.113944,"Both men and women had increased odds of HCV communication with alters who are currently enrolled in drug treatment (AOR 1.7, 95% CI: 1.3-2.4), alters with whom participants share drug preparation equipment (AOR 3.0, 95% CI: 1.9-4.6), alters who are sex partners compared to kin (AOR 3.0; 95% CI: 1.9-4.9) and alters with whom respondents have increased trust (AOR 1.1; 95% CI: 1.11.2) and daily/weekly interactions (AOR 1.7; 95% CI 1.3-2.1).
","[{'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Felsher', 'Affiliation': 'Johns Hopkins University School of Medicine, Division of Infectious Diseases, 5200 Eastern Avenue, MFL Center Tower, Suite 381, Baltimore, MD 21224, USA. Electronic address: marfelsher@gmail.com.'}, {'ForeName': 'Karin E', 'Initials': 'KE', 'LastName': 'Tobin', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD 21205, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sulkowski', 'Affiliation': 'Johns Hopkins University School of Medicine, Division of Infectious Diseases, 5200 Eastern Avenue, MFL Center Tower, Suite 381, Baltimore, MD 21224, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD 21205, USA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Falade-Nwulia', 'Affiliation': 'Johns Hopkins University School of Medicine, Division of Infectious Diseases, 5200 Eastern Avenue, MFL Center Tower, Suite 381, Baltimore, MD 21224, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109157']
2180,34739974,Feasibility and acceptability of testing a menstrual-cycle timed smoking cessation intervention for women of reproductive age (Project Phase): Results of a pilot randomized control trial.,"INTRODUCTION


Menstrual phase influences cigarette smoking-related outcomes. Telephone-based cessation programs (e.g., quitlines) may incorporate the role of the menstrual cycle in an effort to tailor interventions for women.
PURPOSE


The goal of this preliminary randomized clinical trial was to examine the feasibility and acceptability of timing quit date to menstrual phase in women in a quitline setting.
METHODS


We recruited treatment-seeking women with regular menstrual cycles between the ages of 18-40 years. Participants were randomized to the follicular phase (FP; quit date set 6-8 days post onset of menses) or standard of care (SC; no menstrual timing of quit date). All participants received four weeks of nicotine replacement therapy transdermal patch concurrent with six weeks of telephone-based counseling. We explored self-reported and biochemically-verified seven-day point prevalence abstinence at end-of-treatment and three-month follow-up.
RESULTS


Participants (n = 119; FP: n = 58, SC: n = 61) were, on average, 33.4 years old and smoked 13.6 cigarettes/day. The median number of counseling sessions completed was 6 out of 6 available, and 66% of participants completed the intervention. Over 90% of participants reported they would recommend this study to friends/family. Cessation rates did not significantly vary by randomization.
CONCLUSIONS


Results of this preliminary trial indicate that timing quit date to FP is an acceptable and feasible approach to address smoking cessation in women of reproductive age. While we observed similar smoking cessation rates between groups, this preliminary study was not fully powered to determine efficacy. Therefore, the feasibility and acceptability results indicate that a fully-powered efficacy trial is warranted.",2021,"Cessation rates did not significantly vary by randomization.
","['FP: n\xa0=\xa058, SC: n\xa0=\xa061) were, on average, 33.4\xa0years old and smoked 13.6 cigarettes/day', 'seeking women with regular menstrual cycles between the ages of 18-40\xa0years', 'women of reproductive age', 'Participants (n\xa0', '119', 'women of reproductive age (Project Phase', 'women in a quitline setting']","['Telephone-based cessation programs (e.g., quitlines', 'nicotine replacement therapy transdermal patch concurrent with six weeks of telephone-based counseling', 'testing a menstrual-cycle timed smoking cessation intervention']","['median number of counseling sessions', 'smoking cessation rates', 'feasibility and acceptability', 'Cessation rates']","[{'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Proliferative Phase'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",61.0,0.0899437,"Cessation rates did not significantly vary by randomization.
","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, Tucson, AZ, USA. Electronic address: aliciaallen@arizona.edu.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Skobic', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Bell', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Medvescek', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Collins', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, Tucson, AZ, USA; College of Nursing, University of South Florida.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.107153']
2181,34740373,A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial.,"BACKGROUND


Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementation optimisation intervention. This intervention aimed to promote parental enrolment and attendance at HENRY (Health Exercise Nutrition for the Really Young), a UK community obesity prevention programme, by changing behaviours of children's centre and local authority stakeholders.
METHODS


We evaluated the effectiveness of the implementation optimisation intervention on HENRY programme enrolment and attendance over a 12-month implementation period in a cluster randomised controlled trial. We randomised 20 local government authorities (with 126 children's centres) to HENRY plus the implementation optimisation intervention or to HENRY alone. Primary outcomes were (1) the proportion of centres enrolling at least eight parents per programme and (2) the proportion of centres with a minimum of 75% of parents attending at least five of eight sessions per programme. Trial analyses adjusted for stratification factors (pre-randomisation implementation of HENRY, local authority size, deprivation) and allowed for cluster design. A parallel mixed-methods process evaluation used qualitative interviews and routine monitoring to explain trial results.
RESULTS


Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference - 1.2%; 95% CI - 19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95% CI - 15.7%, 18.1%). Unexpectedly, the trial coincided with substantial national service restructuring, including centre closures and reduced funds. Some commissioning and management teams stopped or reduced delivery of both HENRY and the implementation optimisation intervention due to competing demands. Thus, at follow-up, HENRY programmes were delivered to approximately half the number of parents compared to baseline (n = 433 vs. 881).
CONCLUSIONS


During a period in which services were reduced by external policies, this first definitive trial found no evidence of effectiveness for an implementation optimisation intervention promoting parent enrolment to and attendance at an obesity prevention programme.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02675699 . Registered on 4 February 2016.",2021,"Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference - 1.2%; 95% CI - 19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95% CI - 15.7%, 18.1%).","[""126 children's centres) to""]","['HENRY', 'HENRY plus the implementation optimisation intervention or to HENRY alone']",['attendance target'],"[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0582517', 'cui_str': 'henry'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.110503,"Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference - 1.2%; 95% CI - 19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95% CI - 15.7%, 18.1%).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bryant', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York, YO105DD, York, UK. maria.bryant@york.ac.uk.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Burton', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York, YO105DD, York, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Collinson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Nixon', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Departments of Nutrition and Epidemiology, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Roberts', 'Affiliation': 'HENRY Head Office, 8 Elm Place, Old Witney Road, Eynsham, OX29 4BD, UK.'}, {'ForeName': 'Robbie', 'Initials': 'R', 'LastName': 'Foy', 'Affiliation': 'Academic Unit of Primary Care, Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Rutter', 'Affiliation': 'London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Copsey', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Tubeuf', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}]",Trials,['10.1186/s13063-021-05757-w']
2182,34740371,Comparing the effect of in-person and virtual childbirth preparation trainings on the fear of childbirth (FOC) and pregnancy experience of pregnant women: protocol for a quasi-experimental feasibility study.,"BACKGROUND


Childbirth preparation trainings are an important component of prenatal education, and pregnant women are increasingly interested in seeking information from online sources. The aim of this study is to compare the feasibility and the effects of in-person and virtual childbirth preparation training courses on the pregnancy experience, fear of childbirth (FOC), birth preference, and type of delivery among pregnant women.
METHODS


In total, 165 primiparous women referring to a prenatal clinic at Milad Hospital in Tehran, will be included in this study. The subjects will be selected using the convenience sampling method and will be divided into three groups of study A, study B, and control. The study groups A and B will receive virtual and in-person childbirth training with similar content, respectively. The control group will receive only routine prenatal care. In the 18th and 20th weeks of pregnancy, the demographic information, pregnancy experience scale (PES), and version A of the Wijma delivery expectancy/experience questionnaire (WDEQ-A) will be completed, and in the 36th and 38th weeks of pregnancy, the PES and WDEQ-A questionnaires, as well as birth preference form will be completed. The type of delivery will be recorded in the first few days of postpartum.
CONCLUSION


This quasi-experimental clinical trial will investigate the effect of virtual childbirth preparation training on primiparous women. The expected outcomes will include the difference in pregnancy experience measured by the brief version of PES, the difference in FOC measured by WDEQ-A, the birth preference, and the type of delivery.
TRIAL REGISTRATION


IRCT.ir: IRCT20180427039436N2.",2021,"The expected outcomes will include the difference in pregnancy experience measured by the brief version of PES, the difference in FOC measured by WDEQ-A, the birth preference, and the type of delivery.
","['pregnant women', 'primiparous women', '165 primiparous women referring to a prenatal clinic at Milad Hospital in Tehran']","['virtual childbirth preparation training', 'virtual childbirth preparation trainings', 'IRCT.ir']","['fear of childbirth (FOC', 'pregnancy experience, fear of childbirth (FOC), birth preference, and type of delivery', 'FOC measured by WDEQ-A, the birth preference, and the type of delivery', 'pregnancy experience', 'demographic information, pregnancy experience scale (PES), and version A of the Wijma delivery expectancy/experience questionnaire (WDEQ-A']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0150169', 'cui_str': 'Childbirth preparation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0522187', 'cui_str': 'Tocophobia'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",165.0,0.0193866,"The expected outcomes will include the difference in pregnancy experience measured by the brief version of PES, the difference in FOC measured by WDEQ-A, the birth preference, and the type of delivery.
","[{'ForeName': 'Seyedeh Robab', 'Initials': 'SR', 'LastName': 'Mousavi', 'Affiliation': 'Department of Reproductive Health and Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Amiri-Farahani', 'Affiliation': 'Department of Reproductive Health and Midwifery, Nursing Care Research Center (NCRC), School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. l.amirifarahani@gmail.com.'}, {'ForeName': 'Syedeh Batool', 'Initials': 'SB', 'LastName': 'Hasanpoor-Azghady', 'Affiliation': 'Department of Reproductive Health and Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soghra Omrani', 'Initials': 'SO', 'LastName': 'Saravi', 'Affiliation': 'Department of Reproductive Health and Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00933-w']
2183,34740351,Effect of a maternal counselling intervention delivered by community health workers on child nutrition: secondary analysis of a cluster randomised controlled trial in India.,"BACKGROUND


India suffers from a double burden of malnutrition and anaemia. The Karnataka anaemia project indicated that a counselling intervention delivered by community health workers improved anaemia cure rates.
OBJECTIVE


To evaluate the effect of maternal counselling on nutritional aspects of anaemia prevention.
METHODS


Secondary analysis of a cluster randomised controlled trial (55 simultaneously randomised villages using random number generator in Chamrajnagar district, Northern India). In the intervention group mothers of anaemic children received five monthly counselling sessions plus usual care (iron and folic acid supplements), while mothers of anaemic children in the control group received usual care alone. Daily intake of nutrients related to anaemia prevention, i.e. iron (mg) and vitamin C (mg), was estimated using the 24-h dietary recall method at baseline and 6 months follow-up. Linear and logistic mixed regression models were used to assess between-groups difference in changes in nutrients intake from baseline to end of follow-up. Data collectors and analysts were blinded to the group assignment.
RESULTS


Participants were 534 (intervention n = 303; usual treatment n = 231) anaemic children, aged 1 to 5 years and their caregivers, of whom 521(intervention n = 299 from 28 villages; usual treatment n = 222 from 27 villages) were retained at 6 months follow-up and included in the analysis. This study provides inconclusive evidence of improvement in the intake of nutrients that prevent anaemia from baseline to follow-up among the intervention compared to the control group; increase in iron intake was 0.24 mg/day (95% CI -0.67; 1.15) and increase in vitamin C intake was 4.61 mg/day (95% CI -0.69, 9.91). Although encouraging, it is notable that the overall intake of nutrients that prevent anaemia remained well below the national recommended daily allowance.
CONCLUSION


This study provides inconclusive evidence of the effect of parental counselling on nutritional aspects of anaemia prevention. The results highlight the need to devise multi-component anaemia-prevention interventions that include facilitators of the availability of nutritious food and should be evaluated in studies that are adequately powered to detect nutritional changes.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number ISRCTN68413407 , prospectively registered on 17/12/2013.",2021,"This study provides inconclusive evidence of improvement in the intake of nutrients that prevent anaemia from baseline to follow-up among the intervention compared to the control group; increase in iron intake was 0.24 mg/day (95% CI -0.67; 1.15) and increase in vitamin C intake was 4.61 mg/day (95% CI -0.69, 9.91).","['Participants were 534', 'intervention n\u2009=\u2009303; usual treatment n\u2009=\u2009231) anaemic children, aged 1 to 5\u2009years and their caregivers, of whom 521(intervention n\u2009', 'Secondary analysis of a cluster randomised controlled trial (55 simultaneously randomised villages using random number generator in Chamrajnagar district, Northern India', '299 from 28 villages; usual treatment n\u2009=\u2009222 from 27 villages', 'group mothers of anaemic children', 'community health workers on child nutrition']","['maternal counselling', 'vitamin C', 'counselling sessions plus usual care (iron and folic acid supplements', 'parental counselling', 'control group received usual care alone', 'maternal counselling intervention', 'intervention']","['anaemia cure rates', 'iron intake', 'vitamin C intake']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C1720755', 'cui_str': 'Child nutrition'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0518043', 'cui_str': 'Iron intake'}, {'cui': 'C0564420', 'cui_str': 'Vitamin C intake'}]",,0.182854,"This study provides inconclusive evidence of improvement in the intake of nutrients that prevent anaemia from baseline to follow-up among the intervention compared to the control group; increase in iron intake was 0.24 mg/day (95% CI -0.67; 1.15) and increase in vitamin C intake was 4.61 mg/day (95% CI -0.69, 9.91).","[{'ForeName': 'Israa Alzain', 'Initials': 'IA', 'LastName': 'Ali', 'Affiliation': 'Department of Global Public Health, Karolinska Institute, Solnavägen 1E (Torsplan), 11365, Stockholm, Sweden. israa.ali@ki.se.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Shet', 'Affiliation': 'Sickle Cell Branch, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Mascarenhas', 'Affiliation': 'MYRADA, Bangalore, India.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Galanti', 'Affiliation': ""Department of Global Public Health, Karolinska Institute, Centre for Epidemiology and Community Medicine (CES), Stockholm County's Health Care District (SLSO), Stockholm, Sweden.""}]",BMC public health,['10.1186/s12889-021-11998-w']
2184,34740331,Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial.,"BACKGROUND


Soft-tissue sarcomas (STS) represent a heterogeneous group of rare tumors including more than 70 different histological subtypes. High throughput molecular analysis (next generation sequencing exome [NGS]) is a unique opportunity to identify driver mutations that can change the usual one-size-fits-all treatment paradigm to a patient-driven therapeutic strategy. The primary objective of the MULTISARC trial is to assess whether NGS can be conducted for a large proportion of metastatic STS participants within a reasonable time, and, secondarily to determine whether a NGS-guided therapeutic strategy improves participant's outcome.
METHODS


This is a randomized, multicentre, phase II/III trial inspired by the design of umbrella and biomarker-driven trials. The setting plans up to 17 investigational centres across France and the recruitment of 960 participants. Participants aged at least 18 years, with unresectable locally advanced and/or metastatic STS confirmed by the French sarcoma pathological reference network, are randomized according to 1:1 allocation ratio between the experimental arm ""NGS"" and the standard ""No NGS"". NGS will be considered feasible if (i) NGS results are available and interpretable, and (ii) a report of exome sequencing including a clinical recommendation from a multidisciplinary tumor board is provided to investigators within 7 weeks from reception of the samples on the biopathological platform. A feasibility rate of more than 70% is expected (null hypothesis: 70% versus alternative hypothesis: 80%). In terms of care, participants randomized in ""No NGS"" arm and who fail treatment will be able to switch to the NGS arm at the request of the investigator.
DISCUSSION


The MULTISARC trial is a prospective study designed to provide high-level evidence to support the implementation of NGS in routine clinical practice for advanced STS participants, on a large scale.
TRIAL REGISTRATION


clinicaltrial.gov NCT03784014 .",2021,A feasibility rate of more than 70% is expected (null hypothesis: 70% versus alternative hypothesis: 80%).,"['Participants aged at least 18\u2009years, with unresectable locally advanced and/or metastatic STS confirmed by the French sarcoma pathological reference network', 'advanced STS participants', '17 investigational centres across France and the recruitment of 960 participants', 'advanced soft-tissue sarcomas']",['NGS'],[],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C4517908', 'cui_str': '960'}]",[],[],960.0,0.253311,A feasibility rate of more than 70% is expected (null hypothesis: 70% versus alternative hypothesis: 80%).,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Italiano', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, University of Bordeaux, INSERM, Unité ACTION U1218, Bordeaux, France.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Dinart', 'Affiliation': 'University of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France. d.dinart@bordeaux.unicancer.fr.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Soubeyran', 'Affiliation': 'Department of Biopathology, Institut Bergonié, U1218, Bordeaux, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Bellera', 'Affiliation': 'University of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Espérou', 'Affiliation': 'Inserm, Pôle de Recherche Clinique, 75013, Paris, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Delmas', 'Affiliation': 'Inserm, Pôle de Recherche Clinique, 75013, Paris, France.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Mercier', 'Affiliation': 'ANRS (France Recherche Nord&sud Sida-hiv Hépatites), Clinical Trial Safety and Public Health, Paris, France.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Albert', 'Affiliation': 'University of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.'}, {'ForeName': 'Ludivine', 'Initials': 'L', 'LastName': 'Poignie', 'Affiliation': 'Clinical Research and Clinical Epidemiology Unit, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Boland', 'Affiliation': 'Université Paris-Saclay, CEA, Centre National de Recherche en Génomique Humaine, 91057, Evry, France.'}, {'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Bourdon', 'Affiliation': 'U1218, Institut Bergonié, Institut national de la santé et de la recherche médicale, Bordeaux, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Geneste', 'Affiliation': 'U1218, Institut Bergonié, Institut national de la santé et de la recherche médicale, Bordeaux, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Cavaille', 'Affiliation': 'U1218, Institut Bergonié, Institut national de la santé et de la recherche médicale, Bordeaux, France.'}, {'ForeName': ""Yec'han"", 'Initials': 'Y', 'LastName': 'Laizet', 'Affiliation': 'U1218, Institut Bergonié, Institut national de la santé et de la recherche médicale, Bordeaux, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Khalifa', 'Affiliation': 'Department of Biopathology, Institut Bergonié, U1218, Bordeaux, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Auzanneau', 'Affiliation': 'Department of Biopathology, Institut Bergonié, U1218, Bordeaux, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Squiban', 'Affiliation': 'Department of Biopathology, Institut Bergonié, U1218, Bordeaux, France.'}, {'ForeName': 'Nathalène', 'Initials': 'N', 'LastName': 'Truffaux', 'Affiliation': 'Department of Biopathology, Institut Bergonié, U1218, Bordeaux, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Olaso', 'Affiliation': 'Université Paris-Saclay, CEA, Centre National de Recherche en Génomique Humaine, 91057, Evry, France.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Gerber', 'Affiliation': 'Université Paris-Saclay, CEA, Centre National de Recherche en Génomique Humaine, 91057, Evry, France.'}, {'ForeName': 'Cédrick', 'Initials': 'C', 'LastName': 'Wallet', 'Affiliation': 'University of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Bénard', 'Affiliation': 'University of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent-Puig', 'Affiliation': 'Sorbonne Paris Cité, Paris Descartes University, Georges Pompidou European Hospital, Paris, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Deleuze', 'Affiliation': 'Université Paris-Saclay, CEA, Centre National de Recherche en Génomique Humaine, 91057, Evry, France.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Lucchesi', 'Affiliation': 'U1218, Institut Bergonié, Institut national de la santé et de la recherche médicale, Bordeaux, France.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Mathoulin-Pelissier', 'Affiliation': 'University of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-021-08878-2']
2185,34673895,Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia: The COVID STEROID 2 Randomized Trial.,"Importance


A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease.
Objective


To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia.
Design, Setting, and Participants


A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021.
Interventions


Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n = 503) or 6 mg/d of intravenous dexamethasone (n = 497) for up to 10 days.
Main Outcomes and Measures


The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and ≥1 serious adverse reactions at 28 days).
Results


Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P = .07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86 [99% CI, 0.68-1.08]). Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group (adjusted relative risk, 0.87 [99% CI, 0.70-1.07]). Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83 [99% CI, 0.54-1.29]).
Conclusions and Relevance


Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference.
Trial Registration


ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731.",2021,"Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83","['August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation', 'patients with COVID-19 and severe hypoxemia', '1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and', 'Adults With COVID-19 and Severe Hypoxemia']","['intravenous dexamethasone', 'Dexamethasone', 'dexamethasone']","['number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality', 'number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy', 'septic shock and invasive fungal infections', 'Number of Days Alive', 'Serious adverse reactions', 'Mortality', 'median number of days alive without life support']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1262313', 'cui_str': 'Invasive fungal infection'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",1000.0,0.298832,"Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Marie W', 'Initials': 'MW', 'LastName': 'Munch', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Myatra', 'Affiliation': 'Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Bharath Kumar Tirupakuzhi', 'Initials': 'BKT', 'LastName': 'Vijayaraghavan', 'Affiliation': 'Apollo Hospitals, Chennai, India.'}, {'ForeName': 'Sanjith', 'Initials': 'S', 'LastName': 'Saseedharan', 'Affiliation': 'SL Raheja Hospital, Mumbai, India.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Rebecka R', 'Initials': 'RR', 'LastName': 'Wahlin', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bodil S', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Aalborg University Hospital, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Andreasen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Copenhagen University Hospital, Herlev-Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Lone M', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Mohd S', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': 'Rajendra Institute of Medical Sciences, Ranchi, India.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Kapadia', 'Affiliation': 'Hinduja Hospital, Mahim, Mumbai, India.'}, {'ForeName': 'Jigeeshu V', 'Initials': 'JV', 'LastName': 'Divatia', 'Affiliation': 'Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Copenhagen University Hospital, North Zealand, Hilleroed, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Helleberg', 'Affiliation': 'Department of Infectious Diseases, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Michelsen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Padmanaban', 'Affiliation': 'Apollo Hospitals, Chennai, India.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Bose', 'Affiliation': 'Gotri General Hospital, Gujarat, India.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Møller', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Slagelse Hospital, Slagelse, Denmark.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Borawake', 'Affiliation': 'Vishwaraj Hospital, Pune, India.'}, {'ForeName': 'Klaus T', 'Initials': 'KT', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Urvi', 'Initials': 'U', 'LastName': 'Shukla', 'Affiliation': 'Symbiosis University Hospital and Research Centre, Lavale, India.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Chew', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Subhal', 'Initials': 'S', 'LastName': 'Dixit', 'Affiliation': 'Sanjeevan Hospital, Pune, India.'}, {'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Pravin R', 'Initials': 'PR', 'LastName': 'Amin', 'Affiliation': 'Bombay Hospital Institute of Medical Sciences, Mumbai, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Chawla', 'Affiliation': 'Indraprastha Apollo Hospital, New Delhi, India.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Wamberg', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mehul S', 'Initials': 'MS', 'LastName': 'Shah', 'Affiliation': 'Sir H. N. Reliance Foundation Hospital and Research Centre, Mumbai, India.'}, {'ForeName': 'Iben S', 'Initials': 'IS', 'LastName': 'Darfelt', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herning Hospital, Herning, Denmark.'}, {'ForeName': 'Vibeke L', 'Initials': 'VL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Thoracic Anaesthesia, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Smitt', 'Affiliation': 'Department of Neurointensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Maj-Brit N', 'Initials': 'MN', 'LastName': 'Kjær', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Tine S', 'Initials': 'TS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gitte K', 'Initials': 'GK', 'LastName': 'Vesterlund', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Naomi E', 'Initials': 'NE', 'LastName': 'Hammond', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Micallef', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Bassi', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Oommen', 'Initials': 'O', 'LastName': 'John', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Anubhuti', 'Initials': 'A', 'LastName': 'Jha', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cronhjort', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': 'Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Vaijayanti', 'Initials': 'V', 'LastName': 'Kadam', 'Affiliation': 'SL Raheja Hospital, Mumbai, India.'}, {'ForeName': 'Klaus V', 'Initials': 'KV', 'LastName': 'Marcussen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Slagelse Hospital, Slagelse, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hollenberg', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hedman', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Nielsen', 'Affiliation': 'Aalborg University Hospital, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Olav L', 'Initials': 'OL', 'LastName': 'Schjørring', 'Affiliation': 'Aalborg University Hospital, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Marie Q', 'Initials': 'MQ', 'LastName': 'Jensen', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jens W', 'Initials': 'JW', 'LastName': 'Leistner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Trine B', 'Initials': 'TB', 'LastName': 'Jonassen', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Kristensen', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Esben C', 'Initials': 'EC', 'LastName': 'Clapp', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Carl J S', 'Initials': 'CJS', 'LastName': 'Hjortsø', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Liv S', 'Initials': 'LS', 'LastName': 'Halstad', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Emilie R B', 'Initials': 'ERB', 'LastName': 'Bak', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Zaabalawi', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Metcalf-Clausen', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Suhayb', 'Initials': 'S', 'LastName': 'Abdi', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Emma V', 'Initials': 'EV', 'LastName': 'Hatley', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Tobias S', 'Initials': 'TS', 'LastName': 'Aksnes', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Gleipner-Andersen', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Arif F', 'Initials': 'AF', 'LastName': 'Alarcón', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Yamin', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Heymowski', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Berggren', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kirstine', 'Initials': 'K', 'LastName': 'La Cour', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Weihe', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Alison H', 'Initials': 'AH', 'LastName': 'Pind', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Janus', 'Initials': 'J', 'LastName': 'Engstrøm', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Vivekanand', 'Initials': 'V', 'LastName': 'Jha', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",JAMA,['10.1001/jama.2021.18295']
2186,34673258,"Paired Acute Invasive/Non-invasive Stimulation (PAINS) study: A phase I/II randomized, sham-controlled crossover trial in chronic neuropathic pain.","BACKGROUND


Dorsal root ganglion (DRG) stimulation, an invasive method of neuromodulation, and transcranial direct current stimulation (tDCS), a non-invasive method of altering cortical excitability, have both proven effective in relieving chronic pain.
OBJECTIVE


We employed a randomized, sham-controlled crossover study design to investigate whether single-session tDCS would have an additive therapeutic effect alongside DRG stimulation (DRGS) in the treatment of chronic pain.
METHODS


Sixteen neuropathic pain patients who were previously implanted with DRG stimulators were recruited. Baseline pain scores were established with DRGS-OFF. Pain scores were then recorded with DRGS-ON, after paired sham tDCS stimulation, and after paired active anodal tDCS (a-tDCS) stimulation. For active tDCS, patients were randomized to 'MEG (magnetoencephalography) localized' tDCS or contralateral motor cortex (M1) tDCS for 30 min. EEG recordings and evaluations of tDCS adverse effects were also collected.
RESULTS


All participants reported the interventions to be tolerable with no significant adverse effects during the session. Paired DRGS/active tDCS resulted in a significant reduction in pain scores compared to paired DRGS-ON/sham tDCS or DRGS alone. There was no difference in the additive effect of M1 vs. MEG-localized tDCS. Significant augmentation of beta activity was observed between DRGS-OFF and DRGS-ON conditions, as well as between paired DRGS-ON/sham tDCS and paired DRGS-ON/active tDCS.
CONCLUSION


Our results indicate that a single session of tDCS alongside DRGS is safe and can significantly reduce pain acutely in neuropathic pain patients. Paired invasive/non-invasive neuromodulation is a promising new treatment strategy for pain management and should be evaluated further to assess long-term benefits.",2021,Paired DRGS/active tDCS resulted in a significant reduction in pain scores compared to paired DRGS-ON/sham tDCS or DRGS alone.,"['Sixteen neuropathic pain patients who were previously implanted with DRG stimulators were recruited', 'chronic neuropathic pain', 'neuropathic pain patients']","['transcranial direct current stimulation (tDCS', 'DRG stimulation (DRGS', 'single-session tDCS', ""MEG (magnetoencephalography) localized' tDCS or contralateral motor cortex (M1) tDCS""]","['EEG recordings and evaluations of tDCS adverse effects', 'Pain scores', 'pain scores', 'Baseline pain scores', 'beta activity']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0011928', 'cui_str': 'DRG'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.131819,Paired DRGS/active tDCS resulted in a significant reduction in pain scores compared to paired DRGS-ON/sham tDCS or DRGS alone.,"[{'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Parker', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom; Neurosurgery Department, Massachusetts General Hospital, Boston, MA, USA. Electronic address: tparker3@mgh.harvard.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Raghu', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Yongzhi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom; Academy of Medical Engineering and Translational Medicine, Tianjin University, Tianjin, 300072, China.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Gillies', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'FitzGerald', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Tipu', 'Initials': 'T', 'LastName': 'Aziz', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Green', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}]",Brain stimulation,['10.1016/j.brs.2021.10.384']
2187,33215197,Risk Factors for Tuberculosis (TB) Among Household Contacts of Patients With Smear-Positive TB in 8 Provinces of Vietnam: A Nested Case-Control Study.,"BACKGROUND


Tuberculosis (TB) continues to account for significant morbidity and mortality annually. Household contacts (HHCs) of persons with TB are a key population for targeting prevention and control interventions. We aimed to identify risk factors associated with developing TB among HHCs.
METHODS


We conducted a nested case-control study among HHCs in 8 provinces in Vietnam enrolled in a randomized controlled trial of active case finding for TB. Cases were any HHCs diagnosed and registered with TB within the Vietnam National TB Program during 2 years of follow-up. Controls were selected by simple random sampling from the remaining HHCs. Risk factor data were collected at enrollment and during follow-up. A logistic regression model was developed to determine predictors of TB among HHCs.
RESULTS


We selected 1254 HHCs for the analysis: 214 cases and 1040 controls. Underlying characteristics varied between both groups; cases were older, more likely to be male, with a higher proportion of reported previous TB and diabetes. Risk factors associated with a TB diagnosis included being male (adjusted odds ratio [aOR], 1.4; 95% confidence interval [CI], 1.03-2.0), residing in an urban setting (aOR, 1.8; 1.3-2.5), prior TB (aOR, 4.6; 2.5-8.7), history of diabetes (aOR, 3.1; 1.7-5.8), current smoking (aOR, 3.1; 2.2-4.4), and prolonged history of coughing in the index case at enrollment (OR , 1.6; 1.1-2.3).
CONCLUSIONS


Household contacts remain an important key population for TB prevention and control. TB programs should ensure effective contact investigations are implemented for household contacts, particularly those with additional risk factors for developing TB.",2021,"Underlying characteristics varied between both groups; cases were older, more likely to be male, with a higher proportion of reported previous TB and diabetes.","['1254 HHCs for the analysis: 214 cases and 1040 controls', '8 provinces in Vietnam enrolled in a randomized controlled trial of active case finding for TB']",['HHCs'],"['Risk factor data', 'current smoking', 'prolonged history of coughing', 'history of diabetes']","[{'cui': 'C1833213', 'cui_str': 'Hyperferritinemia cataract syndrome'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}]","[{'cui': 'C1833213', 'cui_str': 'Hyperferritinemia cataract syndrome'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",1254.0,0.138221,"Underlying characteristics varied between both groups; cases were older, more likely to be male, with a higher proportion of reported previous TB and diabetes.","[{'ForeName': 'Kavindhran', 'Initials': 'K', 'LastName': 'Velen', 'Affiliation': 'Sydney Medical School, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Nguyen Viet', 'Initials': 'NV', 'LastName': 'Nhung', 'Affiliation': 'National Lung Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Nguyen Thu', 'Initials': 'NT', 'LastName': 'Anh', 'Affiliation': 'Woolcock Institute of Medical Research, Sydney, Australia.'}, {'ForeName': 'Pham Duc', 'Initials': 'PD', 'LastName': 'Cuong', 'Affiliation': 'Woolcock Institute of Medical Research, Sydney, Australia.'}, {'ForeName': 'Nguyen Binh', 'Initials': 'NB', 'LastName': 'Hoa', 'Affiliation': 'National Lung Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Nguyen Kim', 'Initials': 'NK', 'LastName': 'Cuong', 'Affiliation': 'National Lung Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Nguyen Huy', 'Initials': 'NH', 'LastName': 'Dung', 'Affiliation': 'Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Dinh Ngoc', 'Initials': 'DN', 'LastName': 'Sy', 'Affiliation': 'National Lung Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Warwick John', 'Initials': 'WJ', 'LastName': 'Britton', 'Affiliation': 'Centenary Institute of Cancer Medicine and Cell Biology, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Guy Barrington', 'Initials': 'GB', 'LastName': 'Marks', 'Affiliation': 'Woolcock Institute of Medical Research, Sydney, Australia.'}, {'ForeName': 'Greg James', 'Initials': 'GJ', 'LastName': 'Fox', 'Affiliation': 'Sydney Medical School, The University of Sydney, Sydney, Australia.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1742']
2188,34661903,Provision of folic acid for reducing arsenic toxicity in arsenic-exposed children and adults.,"BACKGROUND


Arsenic is a common environmental toxin. Exposure to arsenic (particularly its inorganic form) through contaminated food and drinking water is an important public health burden worldwide, and is associated with increased risk of neurotoxicity, congenital anomalies, cancer, and adverse neurodevelopment in children. Arsenic is excreted following methylation reactions, which are mediated by folate. Provision of folate through folic acid supplements could facilitate arsenic methylation and excretion, thereby reducing arsenic toxicity.
OBJECTIVES


To assess the effects of provision of folic acid (through fortified foods or supplements), alone or in combination with other nutrients, in lessening the burden of arsenic-related health outcomes and reducing arsenic toxicity in arsenic-exposed populations.
SEARCH METHODS


In September 2020, we searched CENTRAL, MEDLINE, Embase, 10 other international databases, nine regional databases, and two trials registers.
SELECTION CRITERIA


Randomised controlled trials (RCTs) and quasi-RCTs comparing the provision of folic acid (at any dose or duration), alone or in combination with other nutrients or nutrient supplements, with no intervention, placebo, unfortified food, or the same nutrient or supplements without folic acid, in arsenic-exposed populations of all ages and genders.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane.
MAIN RESULTS


We included two RCTs with 822 adults exposed to arsenic-contaminated drinking water in Bangladesh. The RCTs compared 400 µg/d (FA400) or 800 µg/d (FA800) folic acid supplements, given for 12 or 24 weeks, with placebo. One RCT, a multi-armed trial, compared FA400 plus creatine (3 g/d) to creatine alone. We judged both RCTs at low risk of bias in all domains. Due to differences in co-intervention, arsenic exposure, and participants' nutritional status, we could not conduct meta-analyses, and therefore, provide a narrative description of the data. Neither RCT reported on cancer, all-cause mortality, neurocognitive function, or congenital anomalies. Folic acid supplements alone versus placebo Blood arsenic. In arsenic-exposed individuals, FA likely reduces blood arsenic concentrations compared to placebo (2 studies, 536 participants; moderate-certainty evidence). For folate-deficient and folate-replete participants who received arsenic-removal water filters as a co-intervention, FA800 reduced blood arsenic levels more than placebo (percentage change (%change) in geometric mean (GM) FA800 -17.8%, 95% confidence intervals (CI) -25.0 to -9.8; placebo GM -9.5%, 95% CI -16.5 to -1.8; 1 study, 406 participants). In one study with 130 participants with low baseline plasma folate, FA400 reduced total blood arsenic (%change FA400 mean (M) -13.62%, standard error (SE) ± 2.87; placebo M -2.49%, SE ± 3.25), and monomethylarsonic acid (MMA) concentrations (%change FA400 M -22.24%, SE ± 2.86; placebo M -1.24%, SE ± 3.59) more than placebo. Inorganic arsenic (InAs) concentrations reduced in both groups (%change FA400 M -18.54%, SE ± 3.60; placebo M -10.61%, SE ± 3.38). There was little to no change in dimethylarsinic acid (DMA) in either group. Urinary arsenic. In arsenic-exposed individuals, FA likely reduces the proportion of total urinary arsenic excreted as InAs (%InAs) and MMA (%MMA) and increases the proportion excreted as DMA (%DMA) to a greater extent than placebo (2 studies, 546 participants; moderate-certainty evidence), suggesting that FA enhances arsenic methylation. In a mixed folate-deficient and folate-replete population (1 study, 352 participants) receiving arsenic-removal water filters as a co-intervention, groups receiving FA had a greater decrease in %InAs (within-person change FA400 M -0.09%, 95% CI -0.17 to -0.01; FA800 M -0.14%, 95% CI -0.21 to -0.06; placebo M 0.05%, 95% CI 0.00 to 0.10), a greater decrease in %MMA (within-person change FA400 M -1.80%, 95% CI -2.53 to -1.07; FA800 M -2.60%, 95% CI -3.35 to -1.85; placebo M 0.15%, 95% CI -0.37 to 0.68), and a greater increase in %DMA (within-person change FA400 M 3.25%, 95% CI 1.81 to 4.68; FA800 M 4.57%, 95% CI 3.20 to 5.95; placebo M -1.17%, 95% CI -2.18 to -0.17), compared to placebo. In 194 participants with low baseline plasma folate, FA reduced %InAs (%change FA400 M -0.31%, SE ± 0.04; placebo M -0.13%, SE ± 0.04) and %MMA (%change FA400 M -2.6%, SE ± 0.37; placebo M -0.71%, SE ± 0.43), and increased %DMA (%change FA400 M 5.9%, SE ± 0.82; placebo M 2.14%, SE ± 0.71), more than placebo. Plasma homocysteine: In arsenic-exposed individuals, FA400 likely reduces homocysteine concentrations to a greater extent than placebo (2 studies, 448 participants; moderate-certainty evidence), in the mixed folate-deficient and folate-replete population receiving arsenic-removal water filters as a co-intervention (%change in GM FA400 -23.4%, 95% CI -27.1 to -19.5; placebo -1.3%, 95% CI -5.3 to 3.1; 1 study, 254 participants), and participants with low baseline plasma folate (within-person change FA400 M -3.06 µmol/L, SE ± 3.51; placebo M -0.05 µmol/L, SE ± 4.31; 1 study, 194 participants). FA supplements plus other nutrient supplements versus nutrient supplements alone In arsenic-exposed individuals who received arsenic-removal water filters as a co-intervention, FA400 plus creatine may reduce blood arsenic concentrations more than creatine alone (%change in GM FA400 + creatine -14%, 95% CI -22.2 to -5.0; creatine -7.0%, 95% CI -14.8 to 1.5; 1 study, 204 participants; low-certainty evidence); may not change urinary arsenic methylation indices (FA400 + creatine: %InAs M 13.2%, SE ± 7.0; %MMA M 10.8, SE ± 4.1; %DMA M 76, SE ± 7.8; creatine: %InAs M 14.8, SE ± 5.5; %MMA M 12.8, SE ± 4.0; %DMA M 72.4, SE ±7.6; 1 study, 190 participants; low-certainty evidence); and may reduce homocysteine concentrations to a greater extent (%change in GM FA400 + creatinine -21%, 95% CI -25.2 to -16.4; creatine -4.3%, 95% CI -9.0 to 0.7; 1 study, 204 participants; low-certainty evidence) than creatine alone.
AUTHORS' CONCLUSIONS


There is moderate-certainty evidence that FA supplements may benefit blood arsenic concentration, urinary arsenic methylation profiles, and plasma homocysteine concentration versus placebo. There is low-certainty evidence that FA supplements plus other nutrients may benefit blood arsenic and plasma homocysteine concentrations versus nutrients alone. No studies reported on cancer, all-cause mortality, neurocognitive function, or congenital anomalies. Given the limited number of RCTs, more studies conducted in diverse settings are needed to assess the effects of FA on arsenic-related health outcomes and arsenic toxicity in arsenic-exposed adults and children.",2021,"FA800 M -0.14%, 95% CI -0.21 to -0.06; placebo M 0.05%, 95% CI 0.00 to 0.10), a greater decrease in %MMA (within-person change FA400 M -1.80%, 95% CI -2.53 to -1.07; FA800 M -2.60%, 95% CI -3.35 to -1.85; placebo M 0.15%, 95% CI -0.37 to 0.68), and a greater increase in %DMA (within-person change FA400 M 3.25%, 95% CI 1.81 to 4.68; FA800 M 4.57%, 95% CI 3.20 to 5.95; placebo M -1.17%, 95% CI -2.18 to -0.17), compared to placebo.","['arsenic-exposed children and adults', 'arsenic-exposed populations', '130 participants with low baseline plasma folate, FA400 reduced total blood arsenic (%change', '822 adults exposed to arsenic-contaminated drinking water in Bangladesh', 'arsenic-exposed adults and children', '352 participants) receiving', 'children']","['arsenic-removal water filters', 'folic acid supplements', 'folic acid', 'Folic acid supplements alone versus placebo Blood arsenic', 'placebo', 'folic acid (at any dose or duration), alone or in combination with other nutrients or nutrient supplements, with no intervention, placebo, unfortified food, or the same nutrient or supplements without folic acid']","['monomethylarsonic acid (MMA) concentrations', 'Inorganic arsenic (InAs) concentrations', 'arsenic toxicity', 'dimethylarsinic acid (DMA', 'DMA', 'blood arsenic and plasma homocysteine concentrations', 'Urinary arsenic', 'Plasma homocysteine', 'urinary arsenic methylation indices', 'MMA', 'cause mortality, neurocognitive function, or congenital anomalies', 'blood arsenic concentrations', 'proportion of total urinary arsenic', 'homocysteine concentrations', 'blood arsenic concentration, urinary arsenic methylation profiles, and plasma homocysteine concentration', 'blood arsenic levels']","[{'cui': 'C0003818', 'cui_str': 'Arsenic'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0003818', 'cui_str': 'Arsenic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3653937', 'cui_str': 'OTHER NUTRIENTS'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0066766', 'cui_str': 'monomethylarsonic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0936225', 'cui_str': 'Inorganic arsenic'}, {'cui': 'C0311375', 'cui_str': 'Toxic effect of arsenic and its compounds'}, {'cui': 'C0006628', 'cui_str': 'Dimethylarsinic Acid'}, {'cui': 'C0013013', 'cui_str': 'Commonwealth of Dominica'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0003818', 'cui_str': 'Arsenic'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0202325', 'cui_str': 'Arsenic measurement, blood'}]",194.0,0.478017,"FA800 M -0.14%, 95% CI -0.21 to -0.06; placebo M 0.05%, 95% CI 0.00 to 0.10), a greater decrease in %MMA (within-person change FA400 M -1.80%, 95% CI -2.53 to -1.07; FA800 M -2.60%, 95% CI -3.35 to -1.85; placebo M 0.15%, 95% CI -0.37 to 0.68), and a greater increase in %DMA (within-person change FA400 M 3.25%, 95% CI 1.81 to 4.68; FA800 M 4.57%, 95% CI 3.20 to 5.95; placebo M -1.17%, 95% CI -2.18 to -0.17), compared to placebo.","[{'ForeName': 'Sajin', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Kamynina', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Guetterman', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Adetutu F', 'Initials': 'AF', 'LastName': 'Farinola', 'Affiliation': 'Faculty of Public Health, Department of Human Nutrition and Dietetics, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Caudill', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Berry', 'Affiliation': 'National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cassano', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Stover', 'Affiliation': 'Texas A&M University, College Station, TX, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012649.pub2']
2189,34658006,"Efficacy and Safety of Sarilumab in patients with COVID19 Pneumonia: A Randomized, Phase III Clinical Trial (SARTRE Study).","INTRODUCTION


SARS-CoV-2 pneumonia is often associated with hyper-inflammation. The cytokine-storm-like is one of the targets of current therapies for coronavirus disease 2019 (COVID-19). High Interleukin-6 (IL6) blood levels have been identified in severe COVID-19 disease, but there are still uncertainties regarding the actual role of anti-IL6 antagonists in COVID-19 management. Our hypothesis was that the use of sarilumab plus corticosteroids at an early stage of the hyper-inflammatory syndrome would be beneficial and prevent progression to acute respiratory distress syndrome (ARDS).
METHODS


We randomly assigned (in a 1:1 ratio) COVID-19 pneumonia hospitalized patients under standard oxygen therapy and laboratory evidence of hyper-inflammation to receive sarilumab plus usual care (experimental group) or usual care alone (control group). Corticosteroids were given to all patients at a 1 mg/kg/day of methylprednisolone for at least 3 days. The primary outcome was the proportion of patients progressing to severe respiratory failure (defined as a score in the Brescia-COVID19 scale ≥ 3) up to day 15.
RESULTS


A total of 201 patients underwent randomization: 99 patients in the sarilumab group and 102 patients in the control group. The rate of patients progressing to severe respiratory failure (Brescia-COVID scale score ≥ 3) up to day 15 was 16.16% in the Sarilumab group versus 15.69% in the control group (RR 1.03; 95% CI 0.48-2.20). No relevant safety issues were identified.
CONCLUSIONS


In hospitalized patients with Covid-19 pneumonia, who were under standard oxygen therapy and who presented analytical inflammatory parameters, an early therapeutic intervention with sarilumab plus standard of care (including corticosteroids) was not shown to be more effective than current standard of care alone. The study was registered at EudraCT with number: 2020-002037-15.",2021,"No relevant safety issues were identified.
","['patients with COVID19 Pneumonia', '201 patients underwent randomization: 99 patients in the sarilumab group and 102 patients in the control group', 'hospitalized patients with Covid-19 pneumonia, who were under standard oxygen therapy and who presented analytical inflammatory parameters, an early therapeutic intervention with', 'COVID-19 pneumonia hospitalized patients under standard oxygen therapy and laboratory evidence of hyper-inflammation to receive']","['Corticosteroids', 'methylprednisolone', 'Sarilumab', 'sarilumab plus usual care (experimental group) or usual care alone (control group', 'sarilumab plus corticosteroids', 'sarilumab plus standard of care (including corticosteroids']","['proportion of patients progressing to severe respiratory failure', 'Efficacy and Safety', 'rate of patients progressing to severe respiratory failure (Brescia-COVID scale score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",201.0,0.0604053,"No relevant safety issues were identified.
","[{'ForeName': 'Aránzazu', 'Initials': 'A', 'LastName': 'Sancho-López', 'Affiliation': 'Clinical Pharmacology Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, C/ Joaquín Rodrigo, 1, 28222, Majadahonda, Madrid, Spain. asancho.hpth@gmail.com.'}, {'ForeName': 'Antonio F', 'Initials': 'AF', 'LastName': 'Caballero-Bermejo', 'Affiliation': 'Clinical Pharmacology Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, C/ Joaquín Rodrigo, 1, 28222, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Ruiz-Antorán', 'Affiliation': 'Clinical Pharmacology Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, C/ Joaquín Rodrigo, 1, 28222, Majadahonda, Madrid, Spain. bruizantoran@gmail.com.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Múñez Rubio', 'Affiliation': 'Infectious Diseases Unit. Internal Medicine Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'García Gasalla', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Son Espases-IdISBa, Mallorca, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Buades', 'Affiliation': 'Internal Medicine Department, Hospital Universitari Son Llatzer, Mallorca, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'González Rozas', 'Affiliation': 'Internal Medicine Department, Complejo Asistencial de Segovia, Segovia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'López Veloso', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Burgos, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Muñoz Gómez', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Infanta Cristina, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cuenca Abarca', 'Affiliation': 'Internal Medicine Department, Hospital Universitario El Escorial, Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Durán Del Campo', 'Affiliation': 'Infectious Diseases Unit. Internal Medicine Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Fátima', 'Initials': 'F', 'LastName': 'Ibáñez', 'Affiliation': 'Infectious Diseases Unit. Internal Medicine Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Díaz de Santiago', 'Affiliation': 'Infectious Diseases Unit. Internal Medicine Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Romero', 'Affiliation': 'Infectious Diseases Unit. Internal Medicine Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Calderón', 'Affiliation': 'Infectious Diseases Unit. Internal Medicine Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Ilduara', 'Initials': 'I', 'LastName': 'Pintos', 'Affiliation': 'Infectious Diseases Unit. Internal Medicine Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Ferre Beltrán', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Son Espases-IdISBa, Mallorca, Spain.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Centeno Soto', 'Affiliation': 'Clinical Pharmacology Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, C/ Joaquín Rodrigo, 1, 28222, Majadahonda, Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Campos', 'Affiliation': 'Rheumatology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ramos Martínez', 'Affiliation': 'Infectious Diseases Unit. Internal Medicine Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Avendaño-Solá', 'Affiliation': 'Clinical Pharmacology Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, C/ Joaquín Rodrigo, 1, 28222, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fernández Cruz', 'Affiliation': 'Infectious Diseases Unit. Internal Medicine Department. Hospital, Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Infectious diseases and therapy,['10.1007/s40121-021-00543-2']
2190,34737091,The impact of lofexidine on stress-related opioid craving and relapse: Design and methodology of a randomized clinical trial.,"Opioid Use Disorders (OUDs) and drug overdose deaths are increasing at alarmingly high rates in the United States. Stress and dysregulation in biologic stress response systems such as the hypothalamic-pituitary-adrenal axis and noradrenergic system appear to play an important role in the pathophysiology of substance use disorders and relapse to drug use, particularly for women. Alpha-2 adrenergic agonist medications effectively decrease noradrenergic activity and have demonstrated benefit in preventing relapse to substance use and decreasing stress-reactivity and craving in cocaine- and nicotine-dependent women, compared to men. Alpha-2 adrenergic agonists may help decrease stress reactivity in individuals with OUDs and prevent relapse to drug use, but gender differences have yet to be systematically explored. We describe the rationale, study design and methodology of a randomized, double-blind, placebo-controlled clinical trial examining gender differences in stress, craving and drug use among adult men and women with OUD taking methadone or buprenorphine and randomly assigned to an alpha-2 adrenergic agonist, lofexidine, compared to placebo. In addition, we describe methods for measuring daily stress, craving and drug use in participant's natural environment as well as participant's physiological (i.e., heart rate, cortisol) and psychological (i.e., stress, craving) response to laboratory social and drug cue stressors. Lastly, we detail methods adopted to sustain research activity while following guidelines for the COVID-19 pandemic. ClinicalTrials.gov Registration Number: NCT03718065.",2021,Opioid Use Disorders (OUDs) and drug overdose deaths are increasing at alarmingly high rates in the United States.,['adult men and women with OUD taking methadone or'],"['lofexidine', 'alpha-2 adrenergic agonist, lofexidine', 'placebo', 'buprenorphine']","[""daily stress, craving and drug use in participant's natural environment as well as participant's physiological (i.e., heart rate, cortisol) and psychological (i.e., stress, craving) response to laboratory social and drug cue stressors"", 'stress reactivity', 'noradrenergic activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}]","[{'cui': 'C0065152', 'cui_str': 'lofexidine'}, {'cui': 'C2746076', 'cui_str': 'Alpha-2 adrenergic receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0557745', 'cui_str': 'Natural environment'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.251705,Opioid Use Disorders (OUDs) and drug overdose deaths are increasing at alarmingly high rates in the United States.,"[{'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: guille@musc.edu.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kingce@musc.edu.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: ramakris@musc.edu.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: bakern@musc.edu.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Cortese', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: corteseb@musc.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Nunn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jenkinli@musc.edu.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Rogers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: rogerst@musc.edu.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'McRae-Clark', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: mcraeal@musc.edu.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bradyk@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106616']
2191,34738243,Qualitative evaluation of a scalable early childhood parenting programme in rural Colombia.,"BACKGROUND


Integrating early childhood parenting programmes into existing government services is a key strategy for reducing the loss of children's developmental potential in low- and middle-income countries. There is limited evidence of participants' perceptions of these programmes, especially when implemented at scale. We integrated an intervention into an existing government programme targeting pregnant women and mothers of children up to 2 years of age and their families in rural Colombia.
METHODS


As part of a cluster randomized trial, 171 government workers (facilitators) implemented the intervention. The intervention included four components: (1) structured curricula, (2) play materials, (3) nutrition and (4) training and supervision. In this qualitative evaluation of the programme, we conducted semi-structured interviews with beneficiary mothers (n = 62), facilitators (n = 40) and supervisors (n = 8). Topic guides were developed to collect information on participants' perspectives of the acceptability, feasibility and effectiveness of the intervention and the enablers and barriers to implementation. All interviews were audiotaped and transcribed, and data were analysed using the framework approach.
RESULTS


Participants' responses indicated that the intervention was acceptable, feasible and effective. Key enablers to implementation were (1) the use of evidence-based behaviour change techniques leading to interactive, fun and participatory sessions; (2) structured curricula with easy to use, simple activities and materials; (3) the focus on positive, supportive relationships; and (4) the perceived benefits of the programme to the beneficiary mothers, children and families, facilitators and programme supervisors. The main barriers were (1) facilitators took time to become comfortable and competent in using the new participatory methodology and (2) the logistics related to making and distributing the play materials.
CONCLUSION


Providing structured curricula and play materials with training and ongoing supervision to enhance an existing programme targeting mothers, families and children was reported as acceptable, feasible and effective by beneficiary mothers and programme staff.",2021,"Providing structured curricula and play materials with training and ongoing supervision to enhance an existing programme targeting mothers, families and children was reported as acceptable, feasible, and effective by beneficiary mothers and programme staff.","['Rural Colombia', 'semi-structured interviews with beneficiary mothers (n=62), facilitators (n=40) and supervisors (n=8', 'pregnant women and mothers of children up to two years of age and their families in rural Colombia', '171 government workers (facilitators']","['structured curricula, 2) play materials, 3) nutrition, and 4) training and supervision', 'Scalable Early Childhood Parenting Programme']","['acceptable, feasible and effective']","[{'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",171.0,0.00997651,"Providing structured curricula and play materials with training and ongoing supervision to enhance an existing programme targeting mothers, families and children was reported as acceptable, feasible, and effective by beneficiary mothers and programme staff.","[{'ForeName': 'Maria Lucia', 'Initials': 'ML', 'LastName': 'Gomez', 'Affiliation': 'School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Bernal', 'Affiliation': 'Economics Department, Universidad de Los Andes, Bogotá, Colombia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Baker-Henningham', 'Affiliation': 'School of Psychology, Bangor University, Bangor, UK.'}]","Child: care, health and development",['10.1111/cch.12921']
2192,34738362,Anxiety among the parents of pediatric patients receiving IVIG therapy during the Covid-19 pandemic.,"BACKGROUND


Symptomatic COVID-19 cases in children occur mostly in those with primary immunodeficiency (PID), chronic lung diseases, and heart disease. Guidelines recommend that patients with PID continue to use their regular medication during the pandemic.
OBJECTIVES


This study aimed to evaluate anxiety related to COVID-19 in the parents of patients receiving intravenous immunoglobulin (IVIG) treatment in our hospital and to evaluate the effect of their anxiety on the continuity of treatment.
METHODS


The parents of the patients who underwent IVIG therapy in our clinic during the pandemic (between May 15, 2020 and July 1, 2020) were included in our study.
RESULTS


Twenty-seven patients with PID whose IVIG therapy was initiated before the pandemic and 29 non- PID control subjects were included in the study. All patients received IVIG treatment in our clinic continued treatment during the pandemic at the same dose intervals. Parents in the IVIG group had significantly higher state (p=0.003) and trait (p=0.003) anxiety scores compared to control parents. IVIG group showed statistically significant higher scores in Beck depression inventory, than the control group (p=0.002).
CONCLUSIONS


The parents of PID patients who needed to come to the hospital for IVIG therapy had higher anxiety levels than the parents of similar aged children who presented to our clinic for different complaints between the same dates. Despite their concerns, the parents of all patients under IVIG therapy maintained treatment continuity at the recommended treatment intervals. None of our immunodeficient patients who presented for treatment during the pandemic contracted COVID-19 infection during our study.",2021,"IVIG group showed statistically significant higher scores in Beck depression inventory, than the control group (p=0.002).
","['Twenty-seven patients with PID whose IVIG therapy was initiated before the pandemic and 29 non', 'parents of PID patients who needed to come to the hospital for', 'in our clinic during the pandemic (between May 15, 2020 and July 1, 2020) were included in our study', 'PID control subjects', 'parents of pediatric patients receiving IVIG therapy during the Covid-19 pandemic', 'parents of patients receiving']","['IVIG treatment', 'IVIG therapy', 'intravenous immunoglobulin (IVIG']","['anxiety scores', 'anxiety levels', 'Anxiety', 'Beck depression inventory']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0398686', 'cui_str': 'Primary immune deficiency disorder'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",27.0,0.0363533,"IVIG group showed statistically significant higher scores in Beck depression inventory, than the control group (p=0.002).
","[{'ForeName': 'Özge Yılmaz', 'Initials': 'ÖY', 'LastName': 'Topal', 'Affiliation': 'Divisions of Pediatrics Allergy and Immunology, Ankara City Hospital, Ankara.'}, {'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Metin', 'Affiliation': 'Divisions of Pediatrics Allergy and Immunology, Ankara City Hospital, Ankara.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Çöp', 'Affiliation': 'Divisions of Child and Adolescent Psychiatry University of Health Sciences, Ankara City Hospital, Ankara.'}, {'ForeName': 'Gülser Şenses', 'Initials': 'GŞ', 'LastName': 'Dinç', 'Affiliation': 'Divisions of Child and Adolescent Psychiatry University of Health Sciences, Ankara City Hospital, Ankara.'}, {'ForeName': 'Özden Şükran', 'Initials': 'ÖŞ', 'LastName': 'Üneri', 'Affiliation': 'Department of Psychology, İstanbul Gelişim University Faculty of Economics, Administrative and Social Sciences, İstanbul, Turkey.'}]",The Turkish journal of pediatrics,['10.24953/turkjped.2021.05.008']
2193,34738551,Nicorandil Decreases Renal Injury in Patients With Coronary Heart Disease Complicated With Type I Cardiorenal Syndrome.,"ABSTRACT


Cardiorenal syndrome (CRS) is a group of disorders in which heart or kidney dysfunction worsens each other. This study aimed to explore the improvement effect of nicorandil on cardiorenal injury in patients with type I CRS. Patients with coronary heart disease complicated with type I CRS were enrolled. Based on the conventional treatment, the patients were prospectively randomized into a conventional treatment group and a nicorandil group, which was treated with 24 mg/d nicorandil intravenously for 1 week. Fasting peripheral venous blood serum and urine were collected before and at the end of treatment. An automatic biochemical analyzer and enzyme linked immunosorbent assay were used to detect B-type brain natriuretic peptide (BNP), serum creatinine (Scr) and cystatin C (Cys-C), renal injury index-kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), and interleukin-18 (IL-18) levels. The left ventricular ejection fraction was measured by echocardiography. All measurements were not significantly different between the nicorandil and conventional treatment groups before treatment (all P > 0.05), and BNP, Scr, Cys-C, NGAL, KIM-1, and IL-18 were decreased in the 2 groups at the end of treatment (all P < 0.05). Compared with the conventional treatment group, BNP, Scr, Cys-C, NGAL, KIM-1, and IL-18 were more significantly decreased in the nicorandil group (all P < 0.05) and left ventricular ejection fraction was more significantly increased (P < 0.05). Therefore, nicorandil could significantly improve the cardiac and renal function of patients with type I CRS. This may prove to be a new therapeutic tool for improving the prognosis and rehabilitation of type I CRS.",2021,"Compared with the conventional treatment group, BNP, Scr, Cys-C, NGAL, KIM-1, and IL-18 were more significantly decreased in the nicorandil group (all P < 0.05) and left ventricular ejection fraction was more significantly increased (P < 0.05).","['Patients with coronary heart disease complicated with type I CRS were enrolled', 'Patients With Coronary Heart Disease Complicated With Type', 'patients with type I CRS']","['Nicorandil', 'nicorandil']","['BNP, Scr, Cys-C, NGAL, KIM-1, and IL-18', 'Fasting peripheral venous blood serum and urine', 'left ventricular ejection fraction', 'cardiac and renal function', 'detect B-type brain natriuretic peptide (BNP), serum creatinine (Scr) and cystatin C (Cys-C), renal injury index-kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), and interleukin-18 (IL-18) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2242703', 'cui_str': 'Cardiorenal syndrome'}]","[{'cui': 'C0068700', 'cui_str': 'Nicorandil'}]","[{'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0197193,"Compared with the conventional treatment group, BNP, Scr, Cys-C, NGAL, KIM-1, and IL-18 were more significantly decreased in the nicorandil group (all P < 0.05) and left ventricular ejection fraction was more significantly increased (P < 0.05).","[{'ForeName': 'Xiaozhi', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ""Department of Emergency, People's Hospital of Huaiyin District, Jinan, China.""}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education and Chinese Ministry of Public Health, Department of Cardiology Qilu Hospital, Qilu Hospital, Shandong University; Jinan, China; and.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education and Chinese Ministry of Public Health, Department of Cardiology Qilu Hospital, Qilu Hospital, Shandong University; Jinan, China; and.'}, {'ForeName': 'Xuezhen', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'Department of Cardiology, Jinan Central Hospital Affiliated to Shandong University, Jinan, China.'}]",Journal of cardiovascular pharmacology,['10.1097/FJC.0000000000001117']
2194,34738912,A Digital Self-management Program (Help to Overcome Problems Effectively) for People Living With Cancer: Feasibility Randomized Controlled Trial.,"BACKGROUND


We present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer.
OBJECTIVE


This study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context.
METHODS


Participants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants' positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web.
RESULTS


The recruitment rate was 77% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50% (all: 21/41, 51%, IG: 10/21, 48%; and CG: 11/20, 55%). The follow-up rate (completing all questionnaires) was greater than 80% (all: 33/41, 80%; IG: 16/21, 76%; and CG: 17/20, 85%). The completion rate (attending ≥3 sessions and completing all questionnaires) was greater than 60% (all: 25/41, 61%; IG: 13/21, 62%; and CG: 12/20, 60%). Engagement data showed that participants viewed between half (5.1/10, 51%) and three-quarters (12.2/16, 76%) of the pages in each session.
CONCLUSIONS


All progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/24264.",2021,"The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation.","['Participants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61', 'people with cancer', 'People Living With Cancer', '41 participants completed the baseline questionnaires']","['waitlist CG', 'digital HOPE program', 'digitally delivered self-management program', 'intervention group (IG) or a waitlist CG', 'Digital Self-management Program', 'CG']","['rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial', 'completion rate', ""self-report measures of participants' positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer"", 'recruitment rate', 'postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation', 'retention rate']","[{'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",41.0,0.389888,"The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation.","[{'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Wright', 'Affiliation': 'Centre for Intelligent Healthcare, Research Institute for Health and Wellbeing, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Martin', 'Affiliation': 'Centre for Intelligent Healthcare, Research Institute for Health and Wellbeing, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Clyne', 'Affiliation': 'National Institute for Health Research, Research Design Service South West, Peninsula Medical School, University of Plymouth, Devon, United Kingdom.'}, {'ForeName': 'Cain C T', 'Initials': 'CCT', 'LastName': 'Clark', 'Affiliation': 'Centre for Intelligent Healthcare, Research Institute for Health and Wellbeing, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Matouskova', 'Affiliation': 'Hope For The Community, Community Interest Company, The Enterprise Hub, Coventry, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGillion', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Centre for Intelligent Healthcare, Research Institute for Health and Wellbeing, Coventry University, Coventry, United Kingdom.'}]",Journal of medical Internet research,['10.2196/28322']
2195,34715162,"Predictive roles of brain-derived neurotrophic factor Val66Met polymorphism on antidepressant efficacy of different forms of prefrontal brain stimulation monotherapy: A randomized, double-blind, sham-controlled study.","BACKGROUND


Although repetitive transcranial magnetic stimulation (rTMS) and prolonged intermittent theta-burst stimulation (piTBS) can induce changes in synaptic plasticity, the influence of brain-derived neurotrophic factor (BDNF) genotypes on their antidepressant effects remain unknown. Hence, we investigated the BDNF polymorphism contribution to the antidepressant effect of different forms left-sided prefrontal stimulations in a randomized, sham-controlled study METHODS: Seventy-five patients with medication-resistant depression were randomly assigned into three monotherapy groups: piTBS, high-frequency(HF) rTMS, or sham. The acute treatment period was two weeks. 17-item Hamilton Depression Rating scale (HDRS-17) were applied at baseline, week-1, and week-2. The primary outcome was percentage changes of HDRS-17 (%HDRS-17 changes) analyzed by generalized estimating equation (GEE) model.
RESULTS


The GEE analysis revealed a significant interaction between group, time, and BDNF genotypes effects on %HDRS-17 changes over time.  In patients carrying Val homozygotes, piTBS and HF-rTMS both exhibited significantly greater %HDRS reduction than sham at week-2. In Met carriers, only piTBS showed better efficacy than sham at week-2 (piTBS vs. sham, -41.1% vs.-18.9%, p=0.004). Regarding the influence of different BDNF genotypes on antidepressant efficacy in each intervention, only HF-rTMS exhibited significantly different degrees of %HDRS-17 changes between Val homozygotes and Met carriers (-68.5% vs. -26.4%, p=0.012, respectively), but piTBS delivered the consistent efficacy regardless of the BDNF polymorphism.
CONCLUSIONS


This is the first study to confirm the different impacts of BDNF genotypes on the effect of different left-sided prefrontal brain stimulation. BDNF Val66Met polymorphism may play a role in the antidepressant response of piTBS and HF-rTMS. (Trial Registration Number UMIN-CTR:UMIN000020892: Registration date: Feb.4, 2016).",2021,"In Met carriers, only piTBS showed better efficacy than sham at week-2",[' Seventy-five patients with medication-resistant depression'],"['repetitive transcranial magnetic stimulation (rTMS) and prolonged intermittent theta-burst stimulation (piTBS', 'brain-derived neurotrophic factor Val66Met polymorphism', 'prefrontal brain stimulation monotherapy', 'piTBS, high-frequency(HF) rTMS, or sham']","['antidepressant efficacy', 'HDRS reduction', '17-item Hamilton Depression Rating scale (HDRS-17', 'percentage changes of HDRS-17 (%HDRS-17 changes) analyzed by generalized estimating equation (GEE) model']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",75.0,0.0808336,"In Met carriers, only piTBS showed better efficacy than sham at week-2","[{'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Institute of Brain Science, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, No.201, Sec.2, Shih-Pai Road, Beitou district, Taipei 112, Taiwan; Division of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Institute of Brain Science, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, No.201, Sec.2, Shih-Pai Road, Beitou district, Taipei 112, Taiwan; Division of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Ching', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Department and Institute of Physiology, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Po-Jui', 'Initials': 'PJ', 'LastName': 'Chu', 'Affiliation': 'School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Institute of Brain Science, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, No.201, Sec.2, Shih-Pai Road, Beitou district, Taipei 112, Taiwan; Division of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, No.201, Sec.2, Shih-Pai Road, Beitou district, Taipei 112, Taiwan; Division of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Institute of Brain Science, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, No.201, Sec.2, Shih-Pai Road, Beitou district, Taipei 112, Taiwan; Division of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Wen-Han', 'Initials': 'WH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, No.201, Sec.2, Shih-Pai Road, Beitou district, Taipei 112, Taiwan; Graduate Institute of Statistics, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Chi-Hung', 'Initials': 'CH', 'LastName': 'Juan', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Institute of Brain Science, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, No.201, Sec.2, Shih-Pai Road, Beitou district, Taipei 112, Taiwan; Division of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Institute of Brain Science, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, No.201, Sec.2, Shih-Pai Road, Beitou district, Taipei 112, Taiwan; Division of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Institute of Brain Science, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, No.201, Sec.2, Shih-Pai Road, Beitou district, Taipei 112, Taiwan; Division of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Psychiatry, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Institute of Brain Science, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, No.201, Sec.2, Shih-Pai Road, Beitou district, Taipei 112, Taiwan; Division of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. Electronic address: ctil2@vghtpe.gov.tw.'}]",Journal of affective disorders,['10.1016/j.jad.2021.10.077']
2196,34715158,A randomised controlled trial evaluating two universal prevention programs for children: Building resilience to manage worry.,"BACKGROUND


Childhood anxiety and depression lead to great distress and impairment. Preventing them simultaneously in early life is critically important. We evaluated the long-term efficacy of an emotion regulation-based (ER) and a behavioural activation-based (BA) program. Both aimed to build resilience to prevent worry, a transdiagnostic feature across anxiety and depression.
METHODS


Participants were 316 students (52.2% female; 8-13 years) from six South Australian primary schools. Schools were randomised to the ER, BA or a control condition. Measures of resilience, worry, anxiety, and depression were taken at pre- and post- program, and at 6- and 12-month follow-up. In addition, levels of emotion regulation, behavioural activation and resilience were measured as potential mediators of changes in anxiety and depression.
RESULTS


No significant condition × time interactions were observed. However, the percentage of children who met the clinical cut-offs for generalised anxiety disorder and major depressive disorder decreased significantly in the BA condition at 12-month follow-up, as well as the percentage of children who met the clinical cut-off for obsessive compulsive disorder in the ER condition. Furthermore, emotion regulation mediated the relationship between condition and worry at post-program in the ER condition.
LIMITATIONS


The sample size is relatively small. Reliance on child self-report may have resulted in inaccurate responses.
CONCLUSION


The ER and BA transdiagnostic prevention programs for childhood anxiety and depression showed promising results for certain anxiety disorders not otherwise observed in universal school-based studies. Future research should consider evaluating the programs with a larger sample using alternative outcome measures.",2021,The ER and BA transdiagnostic prevention programs for childhood anxiety and depression showed promising results for certain anxiety disorders not otherwise observed in universal school-based studies.,"['Participants were 316 students (52.2% female; 8-13 years) from six South Australian primary schools', 'children']",['emotion regulation-based (ER) and a behavioural activation-based (BA) program'],"['levels of emotion regulation, behavioural activation and resilience', 'resilience, worry, anxiety, and depression', 'generalised anxiety disorder and major depressive disorder']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",316.0,0.04353,The ER and BA transdiagnostic prevention programs for childhood anxiety and depression showed promising results for certain anxiety disorders not otherwise observed in universal school-based studies.,"[{'ForeName': 'Junwen', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Research School of Psychology, 39 Science Road, The Australian National University, Canberra, ACT 2601, Australia; College of Education, Psychology and Social Work, Flinders University, GPO Box 2100, Adelaide, SA 5001, Australia. Electronic address: junwen.chen@anu.edu.au.'}, {'ForeName': 'Kristy M', 'Initials': 'KM', 'LastName': 'Johnstone', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, SA 5001, Australia. Electronic address: kristy.johnstone@flinders.edu.au.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kemps', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, SA 5001, Australia. Electronic address: eva.kemps@flinders.edu.au.'}]",Journal of affective disorders,['10.1016/j.jad.2021.10.079']
2197,34731132,A randomized controlled trial to explore the efficacy and safety of transcranial direct current stimulation on patients with post-stroke fatigue.,"BACKGROUND


Post-stroke fatigue seriously affects the quality of life for stroke patients. There is no effective treatment at present. transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation which may have therapeutic effect on post-stroke fatigue. This study will explore about this.
METHOD


A total of 60 patients with post-stroke fatigue were randomly divided into the control group and the treatment group with 30 patients each by minimization randomization. Both groups received basic treatment and conventional rehabilitation. In the treatment group, patients were treated with active tDCS, while in the control group, sham tDCS. Both active and sham tDCS were administered 6 times a week for 4 weeks. Before and after the trial, the Fatigue Severity Scale (FSS), Fugl-Meyer Assessment (FMA) and Modified Barthel Index (MBI) were evaluated and analyzed. And comparisons were made among groups. And there were an 8-week follow-up after the intervention.
RESULT


Before the intervention, there were no significant differences in baseline data and assessment scores between the groups (P > 0.05). After 4 weeks of intervention, FSS scores in the treatment group were significantly lower than those in the control group (P = 0.012), and FMA and BMI scores were significantly higher than those in the control group (P < 0.05). There was no significant change in FSS scores after 8 months of follow-up (P > 0.05).
DISCUSSION


TDCS is a safe treatment that can effectively reduce the degree of fatigue after stroke, improve the motor function and daily activity ability of patients after stroke, and the efficacy is better than only routine rehabilitation training.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry, ChiCTR2000031120. Registered on March 22, 2020.",2021,"There was no significant change in FSS scores after 8 months of follow-up (P > 0.05).
","['60 patients with post-stroke fatigue', 'stroke patients', 'patients with post-stroke fatigue']","['Both active and sham tDCS', 'transcranial direct current stimulation (tDCS', 'TDCS', 'basic treatment and conventional rehabilitation', 'transcranial direct current stimulation', 'active tDCS']","['FMA and BMI scores', 'Fatigue Severity Scale (FSS), Fugl-Meyer Assessment (FMA) and Modified Barthel Index', 'motor function and daily activity ability', 'baseline data and assessment scores', 'efficacy and safety', 'FSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.0301896,"There was no significant change in FSS scores after 8 months of follow-up (P > 0.05).
","[{'ForeName': 'Xiang-Li', 'Initials': 'XL', 'LastName': 'Dong', 'Affiliation': 'Department of Psychosomatic Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'First Clinical Medical School, Nanchang University, Nanchang, China.'}, {'ForeName': 'Wei-Ming', 'Initials': 'WM', 'LastName': 'Sun', 'Affiliation': 'First Clinical Medical School, Nanchang University, Nanchang, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Yuan', 'Affiliation': 'Department of Psychology, Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Guo-Hua', 'Initials': 'GH', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Shuai', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Ye-Feng', 'Initials': 'YF', 'LastName': 'Yuan', 'Affiliation': 'First Clinical Medical School, Nanchang University, Nanchang, China.'}]",Medicine,['10.1097/MD.0000000000027504']
2198,34737490,Facebook Recruitment for Children with Advanced Cancer and Their Parents: Lessons from a Web-based Pediatric Palliative Intervention Study.,"Participant recruitment for pediatric palliative intervention studies is a chronic challenge for researchers. Digital recruitment strategies, or digital technology-assisted recruitment methods used to remotely reach and enroll research subjects, can help address these recruitment challenges for pediatric palliative care clinical trials. This study (a) describes Facebook recruitment procedures targeting children with cancer and their parents for a pediatric palliative intervention randomized clinical trial, (b) reports recruitment results, and (c) discusses successful strategies to recruit pediatric populations via Facebook advertisements. Researchers used Facebook advertisements to recruit children with advanced cancer (aged 7 to 17 years) for a web-based legacy intervention. Between years 2015 and 2018, our research team enrolled 150 child-parent dyads ( N=  300) to participate in the web-based legacy program. Results suggest that Facebook advertisements can be a successful tool to access and recruit pediatric populations with life-threatening conditions. Further research is needed to determine how innovative social-media recruitment strategies could be used in other populations of patients with serious illnesses and their caregivers to further advance the science in palliative care.",2021,"Digital recruitment strategies, or digital technology-assisted recruitment methods used to remotely reach and enroll research subjects, can help address these recruitment challenges for pediatric palliative care clinical trials.","['Between years 2015 and 2018, our research team enrolled 150 child-parent dyads ( N=  300) to participate in the web-based legacy program', 'children with advanced cancer (aged 7 to 17 years) for a web-based legacy intervention', 'pediatric populations via Facebook advertisements', 'targeting children with cancer and their parents', 'Children with Advanced Cancer and Their Parents']","['Facebook advertisements', 'Facebook recruitment procedures']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242538', 'cui_str': 'Inheritance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],,0.0550845,"Digital recruitment strategies, or digital technology-assisted recruitment methods used to remotely reach and enroll research subjects, can help address these recruitment challenges for pediatric palliative care clinical trials.","[{'ForeName': 'Eunji', 'Initials': 'E', 'LastName': 'Cho', 'Affiliation': 'School of Nursing, Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Gilmer', 'Affiliation': 'School of Nursing, Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Friedman', 'Affiliation': 'Division of Hematology-Oncology, Vanderbilt University Medical Center and Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Verna L', 'Initials': 'VL', 'LastName': 'Hendricks-Ferguson', 'Affiliation': 'Trudy Busch Valentine School of Nursing, Saint Louis University, St. Louis, Missouri, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Hinds', 'Affiliation': ""Department of Nursing Science, Professional Practice & Quality, Children's National Health System, George Washington University, Washington, DC.""}, {'ForeName': 'Terrah Foster', 'Initials': 'TF', 'LastName': 'Akard', 'Affiliation': 'School of Nursing, Vanderbilt University, Nashville, Tennessee, USA.'}]",Progress in palliative care,['10.1080/09699260.2021.1898077']
2199,34737472,"Behavioural intervention for adolescent uptake of family planning: a randomized controlled trial, Uganda.","Objective


To evaluate the impact of a peer-referral and clinic welcome programme for reducing barriers to adolescents' uptake of family planning services in Uganda.
Methods


We developed an intervention using behavioural design and carried out a stratified, randomized controlled evaluation of the intervention in girls aged 15-19 years. Sexual and reproductive health clinics were randomized into control (56 clinics) and intervention groups (60 clinics). All intervention clinics received the core intervention (materials to create an adolescent-friendly environment and referral cards to give to friends), while a subset of clinics additionally received training in youth-friendly service provision. We collected clinics' routine data on monthly numbers of visits by adults and adolescents over a 15-month baseline and 6-month intervention period, 2018-2020.
Findings


In multivariate regression analysis we found significant effects of the intervention on primary outcomes in the pooled intervention group compared with control. Mean monthly visits by adolescents increased by 45% (incidence rate ratio, IRR: 1.45; 95% confidence interval, CI: 1.14-1.85), or over five additional adolescent clients per clinic per month. The mean adolescent proportion of total clients improved by 5.3 percentage points (95% CI: 0.02-0.09). Within treatment arms, clinics receiving the training in youth-friendly service provision showed the strongest effects: a 62% increase (IRR: 1.62; 95% CI: 1.21-2.17) in adolescent clients, or over seven additional adolescents per clinic per month, relative to the control group.
Conclusion


A behavioural change intervention designed to target identified barriers can increase adolescents' uptake of family planning counselling and services.",2021,"Mean monthly visits by adolescents increased by 45% (incidence rate ratio, IRR: 1.45; 95% confidence interval, CI: 1.14-1.85), or over five additional adolescent clients per clinic per month.","['adults and adolescents over a 15-month baseline and 6-month intervention period, 2018-2020', ""adolescents' uptake of family planning services in Uganda"", 'Sexual and reproductive health clinics', 'adolescent uptake of family planning', 'girls aged 15-19\xa0years']","['core intervention (materials to create an adolescent-friendly environment and referral cards to give to friends), while a subset of clinics additionally received training in youth-friendly service provision', 'Behavioural intervention', 'peer-referral and clinic welcome programme']","['mean adolescent proportion of total clients', 'Mean monthly visits by adolescents']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557743', 'cui_str': 'Friendly environment'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.175918,"Mean monthly visits by adolescents increased by 45% (incidence rate ratio, IRR: 1.45; 95% confidence interval, CI: 1.14-1.85), or over five additional adolescent clients per clinic per month.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Flanagan', 'Affiliation': 'ideas42, 80 Broad St 30Fl, New York, NY 10004, United States of America (USA).'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Gorstein', 'Affiliation': 'ideas42, 80 Broad St 30Fl, New York, NY 10004, United States of America (USA).'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Nicholson', 'Affiliation': 'MSI Reproductive Choices, London, England.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Bradish', 'Affiliation': 'MSI Reproductive Choices, London, England.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Amanyire', 'Affiliation': 'MSI Reproductive Choices, London, England.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gidudu', 'Affiliation': 'Marie Stopes Uganda, Kampala, Uganda.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Aucur', 'Affiliation': 'Marie Stopes Uganda, Kampala, Uganda.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Twesigye', 'Affiliation': 'Marie Stopes Uganda, Kampala, Uganda.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Kyateka', 'Affiliation': 'Marie Stopes Uganda, Kampala, Uganda.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Balamaga', 'Affiliation': 'Marie Stopes Uganda, Kampala, Uganda.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Buttenheim', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Zimmerman', 'Affiliation': 'ideas42, 80 Broad St 30Fl, New York, NY 10004, United States of America (USA).'}]",Bulletin of the World Health Organization,['10.2471/BLT.20.285339']
2200,34739527,"Early administration of Vitamin C in patients with sepsis or septic shock in emergency departments: A multicenter, double blinded, randomized controlled trial: The C-EASIE trial protocol.","BACKGROUND


Sepsis is a potentially life-threatening condition characterized by a deregulated body's response to infection causing injury to its own tissues and organs. Sepsis is the primary cause of death from infection. If not recognized and treated timely, it can evolve within minutes/hours to septic shock. Sepsis is associated with an acute deficiency of Vitamin C. Despite the proof-of-concept of the benefit of administering Vitamin C in patients with sepsis or septic shock, Vitamin C administration is not yet current practice.
OBJECTIVE


To investigate the potential benefit of early administration of high doses of Vitamin C in addition to standard of care in patients with sepsis or septic shock.
METHODS


This phase 3b multi-center trial is conducted in 8 hospitals throughout Belgium. In total 300 patients will be randomly assigned to one of two groups in a 1:1 allocation ratio. The intervention group will receive 1.5 g Vitamin C 4 times a day during 4 days, started within 6 hours after admission. The primary outcome is the average post-baseline patient SOFA score.
CONCLUSION


This trial will determine whether the early administration of Vitamin C in patients with sepsis or septic shock can lead to a more rapid solution of shock and less deterioration from sepsis to septic shock, hereby reducing morbidity and mortality as well as the length of hospital stay in this patient population.
TRIAL REGISTRATION


The C-EASIE trial has been registered on the ClinicalTrials.gov website on 10 February 2021 with registration number NCT04747795.
TRIAL SPONSOR


UZ Leuven (sponsor's reference S63213).",2021,"This trial will determine whether the early administration of Vitamin C in patients with sepsis or septic shock can lead to a more rapid solution of shock and less deterioration from sepsis to septic shock, hereby reducing morbidity and mortality as well as the length of hospital stay in this patient population.
","['patients with sepsis or septic shock in emergency departments', 'In total 300 patients', 'patients with sepsis or septic shock']",['Vitamin C'],['average post-baseline patient SOFA score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",300.0,0.885129,"This trial will determine whether the early administration of Vitamin C in patients with sepsis or septic shock can lead to a more rapid solution of shock and less deterioration from sepsis to septic shock, hereby reducing morbidity and mortality as well as the length of hospital stay in this patient population.
","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Vandervelden', 'Affiliation': 'Department of Emergency Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wauters', 'Affiliation': 'Department of Emergency Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Breuls', 'Affiliation': 'Department of Emergency Medicine, Algemeen Ziekenhuis Turnhout, Rubensstraat, Turnhout, Belgium.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Fieuws', 'Affiliation': 'Leuven Biostatistics and Statistical Bioinformatics Center (L-BioStat), Kapucijnenvoer, Leuven, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Vanhove', 'Affiliation': 'Department of Intensive Care, GZA Ziekenhuizen, Antwerpen, Belgium.'}, {'ForeName': 'Ives', 'Initials': 'I', 'LastName': 'Hubloue', 'Affiliation': 'Department of Emergency Medicine, University Hospitals Brussel, Jette, Belgium.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Bartiaux', 'Affiliation': 'Department of Emergency Medicine, University Medical Center Saint Pierre, Bruxelles, Belgium.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Creteur', 'Affiliation': 'Department of Intensive Care, Erasme Hospital Brussels, Bruxelles, Belgium.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Stifkens', 'Affiliation': 'Department of Emergency Medicine, Center Hospitalier Universitaire de Liège, Liège, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Monsieurs', 'Affiliation': 'Department of Emergency Medicine, University Hospitals Antwerp, Edegem, Belgium.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Desruelles', 'Affiliation': 'Department of Emergency Medicine, University Hospitals Leuven, Leuven, Belgium.'}]",PloS one,['10.1371/journal.pone.0259699']
2201,34739522,Effect of different Kinesio tape tensions on experimentally-induced thermal and muscle pain in healthy adults.,"Athletes and rehabilitation specialists have used Kinesio tape (KT) to help alleviate pain symptoms. Currently, no clear mechanism exists as to why pain is relieved with the use of KT and whether the pain relieving effect is simply a placebo effect. Additionally, the most effective taping parameters (tension of tape) for pain reduction remain unknown. We used quantitative sensory testing to address these key gaps in the KT and pain literature. Using a repeated-measures laboratory design, we examined whether KT applied at different tensions reduces experimentally-induced pain compared to a no tape condition and KT with minimal tension. Heat pain thresholds (HPT's), pressure pain thresholds (PPT's), and pressure pain suprathreshold (PPS: 125% of PPT) tests were administered to the forearm prior to and during KT and no tape conditions. Tape was applied to the ventral forearm at 25% of max tension, 75% of max tension, and no tension (placebo). Repeated measures ANOVA's evaluated the pain outcomes between conditions and across time. KT had no significant effect on PPT's and HPT's (p's >0.05). The ANOVA on PPS revealed that KT applied at 25% of tension significantly reduced pain ratings from the pretest (M = 34.4, SE = 5.5) to post-test 1 (M = 30.3, SE = 4.7) and post-test 2 (M = 30.4, SE = 4.7). No other conditions significantly reduced suprathreshold pressure pain. However, pain ratings at posttest-1 during the no-tape condition (M = 36.4, SE = 5.3) were significantly greater than pain ratings during post-test 1 and post-test 2 of all three tape conditions. In conclusion, the current study revealed that KT applied at low tension is the optimal tension to reduce pressure-evoked muscle pain. Additionally, the results suggested that KT applied at low, high, or no tension may acutely prevent increased muscle sensitivity with repeated pressure stimulation.",2021,KT had no significant effect on PPT's and HPT's (p's >0.05).,['healthy adults'],"['Kinesio tape tensions', 'max tension, and no tension (placebo', 'Kinesio tape (KT']","[""PPT's and HPT's"", 'pain ratings', 'suprathreshold pressure pain', 'thermal and muscle pain', ""Heat pain thresholds (HPT's), pressure pain thresholds (PPT's), and pressure pain suprathreshold (PPS: 125% of PPT"", 'pressure-evoked muscle pain', 'pain outcomes', 'muscle sensitivity']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0488956,KT had no significant effect on PPT's and HPT's (p's >0.05).,"[{'ForeName': 'Keith E', 'Initials': 'KE', 'LastName': 'Naugle', 'Affiliation': 'Department of Kinesiology, School of Health and Human Sciences, Indiana University Purdue University Indianapolis, Indianapolis, Indiana, United States of America.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hackett', 'Affiliation': 'Regenstrief Institute, Indiana University Center for Aging Research, Indianapolis, Indiana, United States of America.'}, {'ForeName': 'Dania', 'Initials': 'D', 'LastName': 'Aqeel', 'Affiliation': 'Department of Neurology, School of Medicine, Indiana University, Indianapolis, Indiana, United States of America.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Naugle', 'Affiliation': 'Department of Kinesiology, School of Health and Human Sciences, Indiana University Purdue University Indianapolis, Indianapolis, Indiana, United States of America.'}]",PloS one,['10.1371/journal.pone.0259433']
2202,34739947,Enhanced recovery after elective craniotomy: A randomized controlled trial.,"STUDY OBJECTIVES


Enhanced recovery after surgery (ERAS) protocols have been proven to improve outcomes but have not been widely used in neurosurgery. The purpose of this study was to design a multidisciplinary enhanced recovery after elective craniotomy protocol and to evaluate its clinical efficacy and safety after implementation.
DESIGN


A prospective randomized controlled trial.
SETTING


The setting is at an operating room, a post-anesthesia care unit, and a hospital ward.
PATIENTS


This randomized controlled trial (RCT) prospectively analyzed 151 patients who underwent elective craniotomy between January 2019 and June 2020.
INTERVENTIONS


The neurosurgical ERAS group was cared for with evidence-based systematic optimization approaches, while the control group received routine care.
MEASUREMENTS


The primary outcomes were the postoperative length of stay (LOS) and hospitalization costs. The secondary outcomes included 30-day readmission rates, postoperative complications, postoperative pain scores, length of intensive care unit (ICU) stay, duration of the drainage tube, time to oral intake, time to ambulation, and postoperative functional recovery status.
MAIN RESULTS


After ERAS protocol implementation, the median postoperative LOS (4 days to 3 days, difference [95% confidence interval, CI], 2 [1 to 2], P < 0.0001) and hospitalization costs (6266 USD to 5880 USD, difference [95% CI], 427.0 [234.8 to 633.6], P < 0.0001) decreased. Compared to routine perioperative care, the ERAS protocol reduced the incidence of postoperative nausea and vomiting (PONV) (28.0% to 9.2%, adjusted odds ratio [OR] 0.3, 95% CI 0.1-0.7, P = 0.003), shortened urinary catheter removal time by 24 h (64.0% to 83.0%, adjusted OR 2.9, 95% CI 1.3-6.5, P = 0.031), improved ambulation on postoperative day 1 (POD 1) (30.7% to 75.0%, adjusted OR 7.5, 95% CI 3.6-15.8, P < 0.0001), shortened the time to oral intake (15 h to 13 h, difference [95% CI], 3 [1 to 4], P < 0.001), and improved perioperative pain management.
CONCLUSIONS


Implementation of an enhanced recovery after elective craniotomy protocol had significant benefits over conventional perioperative management. It was associated with a significant reduction in postoperative length of stay, medical cost, and postoperative complications.",2021,"< 0.0001), shortened the time to oral intake (15 h to 13 h, difference [95% CI], 3 [1 to 4], P < 0.001), and improved perioperative pain management.
","['The setting is at an operating room, a post-anesthesia care unit, and a hospital ward', '151 patients who underwent elective craniotomy between January 2019 and June 2020']",[],"['perioperative pain management', 'ambulation on postoperative day 1 (POD 1', '30-day readmission rates, postoperative complications, postoperative pain scores, length of intensive care unit (ICU) stay, duration of the drainage tube, time to oral intake, time to ambulation, and postoperative functional recovery status', 'postoperative length of stay (LOS) and hospitalization costs', 'hospitalization costs', 'median postoperative LOS', 'clinical efficacy and safety', 'incidence of postoperative nausea and vomiting (PONV', 'postoperative length of stay, medical cost, and postoperative complications', 'shortened urinary catheter removal time', 'time to oral intake']","[{'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}]",[],"[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",,0.399389,"< 0.0001), shortened the time to oral intake (15 h to 13 h, difference [95% CI], 3 [1 to 4], P < 0.001), and improved perioperative pain management.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yanjin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Tiange', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jiapeng', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology & Perioperative Medicine, University of Louisville, Louisville, KY, United States of America.'}, {'ForeName': 'Qulian', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wangyuan', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha, Hunan, China; National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China. Electronic address: wangyuanzou@csu.edu.cn.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110575']
2203,34739914,Immunological effects of dimethyl fumarate treatment in blood and CSF of patients with primary progressive MS.,"Dimethyl fumarate is an efficient therapy used widely in patients with relapsing-remitting multiple sclerosis (RRMS). However, lacking effect of treatment has recently been reported in patients with primary progressive MS (PPMS) (Højsgaard Chow et al., 2021). In order to further analyze the immunological treatment response we investigated the systemic and intrathecal immunological effects of dimethyl fumarate (DMF) treatment in 50 patients with PPMS who participated in a 48-week randomized controlled trial with dimethyl fumarate vs placebo. We found substantial systemic immunomodulatory effects of DMF treatment comparable with those observed in patients with RRMS. However, intrathecal effects were limited and restricted to CD4 +  T cells presumably resulting in higher concentrations of intrathecal IL-7.",2021,"However, intrathecal effects were limited and restricted to CD4 +  T cells presumably resulting in higher concentrations of intrathecal IL-7.","['patients with RRMS', 'patients with primary progressive MS', 'patients with primary progressive MS (PPMS', '50 patients with PPMS who participated in a 48-week randomized controlled trial with', 'patients with relapsing-remitting multiple sclerosis (RRMS']","['Dimethyl fumarate', 'dimethyl fumarate vs placebo', 'dimethyl fumarate (DMF', 'DMF', 'dimethyl fumarate']",['Immunological effects'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",50.0,0.0511254,"However, intrathecal effects were limited and restricted to CD4 +  T cells presumably resulting in higher concentrations of intrathecal IL-7.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Talbot', 'Affiliation': 'Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital - Rigshospitalet, Glostrup, Denmark. Electronic address: jacob.lando.talbot@regionh.dk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Højsgaard Chow', 'Affiliation': 'Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital - Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Holm Hansen', 'Affiliation': 'Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital - Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'M Rode', 'Initials': 'MR', 'LastName': 'von Essen', 'Affiliation': 'Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital - Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sellebjerg', 'Affiliation': 'Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital - Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of neuroimmunology,['10.1016/j.jneuroim.2021.577756']
2204,34740318,Measurement of the nociceptive flexion reflex threshold in critically ill patients - a randomized observational pilot study.,"BACKGROUND


Pain detection and treatment is a major challenge in the care of critically ill patients, rendered more complex by the need to take into consideration the risk of insufficient or excessive analgesia. The nociceptive flexion reflex threshold (NFRT) has become the established basis for measuring the level of analgesia in the perioperative context. However, it remains unclear whether NFRT measurement can be usefully applied to mechanically ventilated, analgosedated critically ill patients who are unable to communicate. Therefore, the aim of the present study was to investigate whether there is an association between the NFRT measurement and the Behavioral Pain Scale (BPS) in critically ill, analgosedated, and mechanically ventilated patients and whether the NFRT measurement can also detect potential excessive analgesia.
METHODS


This prospective, observational, randomized single-center pilot study included patients admitted to the surgical Intensive Care Unit of University Hospital Ulm, Germany, all of whom were analgosedated and intubated. Major exclusion criteria were defined as the need for the administration of neuromuscular blocking agents or neurological diseases associated with peripheral nerve conduction restriction. Initial NFRT and BPS measurements were conducted within 12 h after admission. A structured pain assessment was performed at least twice daily until extubation throughout the observation period thereafter (Group A: BPS + NFRT, Group B: BPS).
RESULTS


114 patients were included in the study. NFRT is associated negatively with BPS. NFRT was almost twice as high in patients with a Richmond Agitation Sedation Scale (RASS) score of -5 than in patients with a RASS score ≥ -4 (RASS -5 - NFRT: 59.40 vs. RASS -4 - NFRT: 29.00, p < 0.001).
CONCLUSIONS


NFRT measurement is associated negatively with the BPS in critically ill patients. NFRT measurement provides guidance for the evaluation of nociceptive processes in patients with RASS scores ≤ -4, in whom analgesia level is often difficult to assess. However, in order to identify excessive analgesia and derive therapeutic consequences, it is necessary to gradually decrease analgesics and sedatives until a stimulus threshold is reached at which the patient does not feel pain.
TRIAL REGISTRATION


Retrospectively registered in the German Clinical Trials Register, registration number DRKS00021149, date of registration: March 26, 2020. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021149 .",2021,"NFRT measurement provides guidance for the evaluation of nociceptive processes in patients with RASS scores ≤ -4, in whom analgesia level is often difficult to assess.","['critically ill patients', 'patients admitted to the surgical Intensive Care Unit of University Hospital Ulm, Germany, all of whom were analgosedated and intubated', 'patients with RASS scores', '114 patients were included in the study']","['NFRT', 'nociceptive flexion reflex threshold (NFRT']","['Initial NFRT and BPS measurements', 'Richmond Agitation Sedation Scale (RASS) score', 'Behavioral Pain Scale (BPS']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",114.0,0.0454629,"NFRT measurement provides guidance for the evaluation of nociceptive processes in patients with RASS scores ≤ -4, in whom analgesia level is often difficult to assess.","[{'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schick', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany. benedikt-1.zujalovic@uni-ulm.de.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mayer', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, Schwabstraße 13, 89075, Ulm, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Walter', 'Affiliation': 'Department of Medical Psychology, Ulm University, Frauensteige 6, 89075, Ulm, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Gruss', 'Affiliation': 'Department of Medical Psychology, Ulm University, Frauensteige 6, 89075, Ulm, Germany.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Stitz', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Stitz', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Barth', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}]",BMC anesthesiology,['10.1186/s12871-021-01490-8']
2205,34740265,Resorbable Collagen Barrier Impeding the Extrusion of Obturating Material in Primary Molars Undergoing Resorption - A Randomized Clinical Trial.,"OBJECTIVE


To evaluate the effectiveness of placing a resorbable collagen barrier in impeding the extrusion of obturation material in primary molars undergoing resorption.
STUDY DESIGN


All the 94 canals in 47 mandibular molars were allocated to 2 groups- Group 'A'- 47 canals with collagen barrier (Test group) and Group 'B'- 47 canals without collagen barrier (Control group) based on randomization protocol. Pulpectomy was performed and obturation of both test and control canals were radiographically assessed. Pearson's chi - square test was applied to analyze the results. The significance level was predetermined at p < 0.05.
RESULTS


Among the test group, 93.6% of the canals showed no extrusion while, 6.4% showed visible extrusion of the material outside the apex. In the control group, 83% showed no extrusion whereas 17% of the canals showed visible extrusion outside the apex. But no significant difference was noted (p>0.05).
CONCLUSION


The placement of resorbable collagen barrier in the apical third of the canal prevented the extrusion of obturating material beyond the apex in resorbing primary molars.",2021,The placement of resorbable collagen barrier in the apical third of the canal prevented the extrusion of obturating material beyond the apex in resorbing primary molars.,"['primary molars undergoing resorption', 'Primary Molars Undergoing Resorption ', 'All the 94 canals in 47 mandibular molars']","[""2 groups- Group 'A'- 47 canals with collagen barrier (Test group) and Group 'B'- 47 canals without collagen barrier (Control group) based on randomization protocol"", 'Pulpectomy']",[],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}]",[],,0.0660871,The placement of resorbable collagen barrier in the apical third of the canal prevented the extrusion of obturating material beyond the apex in resorbing primary molars.,"[{'ForeName': 'Mishra Neha', 'Initials': 'MN', 'LastName': 'Sanjeev', 'Affiliation': ''}, {'ForeName': 'Harsimran', 'Initials': 'H', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Sandeep Singh', 'Initials': 'SS', 'LastName': 'Mayall', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Rishika', 'Affiliation': ''}, {'ForeName': 'Ramakrishna', 'Initials': 'R', 'LastName': 'Yeluri', 'Affiliation': ''}]",The Journal of clinical pediatric dentistry,['10.17796/1053-4625-45.5.4']
2206,34663193,Combined high-intensity interval training as an obesity-management strategy for adolescents.,"Effective and safe exercise protocols for obesity management in adolescents are imperative. This study aimed to analyse compliance, efficacy, and safety of combined high-intensity interval training circuit (HIIT) in the management of obesity (including overweight) in adolescents, compared to traditional training (TT). Data from 55 adolescents (47.3% girls) (TT  n  = 31; HIIT  n  = 24), aged 12-18 (mean age of 14.3 ± 1.7), with overweight and obesity (median BMI z-score of 2.95), were assessed at baseline and month 6 (Clinicaltrials.gov/NCT02941770). During the 6-month intervention, participants in both exercise groups attended two exercise sessions/week (60 min/session) along with a set of appointments with a paediatrician, nutritionist, and exercise physiologist. Forty-six participants completed the intervention (TT  n  = 23; HIIT  n  = 23). Exercise session attendance (≥80%) was significantly higher among HIIT participants (73.9 vs. 13.0%,  p  < .001). HIIT, but not TT, showed a significant decrease in BMI z-score ( d  = 0.40,  p  < .001), body fat mass (BFM, %) ( d  = 0.41,  p  = .001), and trunk fat mass ( d  = 0.56,  p  < .001), as well as a significant increase in muscle mass (MM, %) ( d  = 0.28,  p  = .001) between baseline and 6 months. According to generalized estimating equations, time-by-attendance interactions (instead of time-by group) were found in BMI z-score ( β  = 0.25, 95%CI: 0.17, 0.33), BFM ( β  = 2.29, 95%CI: 1.02, 3.56), trunk fat mass ( β  = 2.94, 95%CI: 1.70, 4.18), and MM ( β  = -1.16, 95%CI: -1.87, -0.45). No adverse events were reported during HIIT sessions. Although compliance may mediate the impact of an exercise protocol on health-related outcomes, HIIT showed to be safe, with higher compliance compared to TT, which may result in improved outcomes overtime.",2021,"Exercise session attendance (≥80%) was significantly higher among HIIT participants (73.9 vs 13.0%,  p <.001).","['55 adolescents (47.3% girls) (TT  n =31; HIIT  n =24), aged 12 to 18 (mean age of 14.3\u2009±\u20091.7), with overweight and obesity (median BMI z-score of 2.95', 'adolescents', 'obesity (including overweight) in adolescents']","['traditional training (TT', 'Combined high-intensity interval training', 'combined high-intensity interval training circuit (HIIT']","['BMI z-score', 'Exercise session attendance', 'trunk fat mass', 'adverse events', 'muscle mass', 'body fat mass (BFM, ']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",46.0,0.17481,"Exercise session attendance (≥80%) was significantly higher among HIIT participants (73.9 vs 13.0%,  p <.001).","[{'ForeName': 'António', 'Initials': 'A', 'LastName': 'Videira-Silva', 'Affiliation': 'Faculty of Medicine, Pediatric University Clinic, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hetherington-Rauth', 'Affiliation': 'Faculty of Human Kinetics, Exercise and Health Laboratory, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Luís B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': 'Faculty of Human Kinetics, Exercise and Health Laboratory, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Fonseca', 'Affiliation': 'Pediatric Obesity Clinic, Department of Pediatrics, Hospital de Santa Maria, Lisbon, Portugal.'}]",European journal of sport science,['10.1080/17461391.2021.1995508']
2207,34670741,Correction:  CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT) .,,2021,,['Appendicitis in Children'],['CONservative TReatment'],[],"[{'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]",[],,0.193261,,[],Archives of disease in childhood,['10.1136/archdischild-2020-320746corr1']
2208,34670012,Effects of eicosapentaenoic acid on serum levels of selenoprotein P and organ-specific insulin sensitivity in humans with dyslipidemia and type 2 diabetes.,"AIM


Selenoprotein P (SeP, encoded by SELENOP in humans) is a hepatokine that causes insulin resistance in the liver and skeletal muscle. It was found that polyunsaturated fatty acid eicosapentaenoic acid (EPA) downregulates Selenop expression by inactivating SREBP-1c. The present study aimed to examine the effect of EPA for 12 weeks on circulating SeP levels and insulin sensitivity in humans with type 2 diabetes.
METHODS


A total of 20 participants with dyslipidemia and type 2 diabetes were randomly assigned to an EPA (900 mg, twice daily) group and a control group. The primary endpoint was a change in serum SeP levels. Organ-specific insulin sensitivity in the liver (HGP and %HGP), skeletal muscle (Rd), and adipose tissue (FFA and %FFA) were assessed using a hyperinsulinemic-euglycemic clamp study with stable isotope-labeled glucose infusion.
RESULTS


Serum SeP levels were not changed in either group at the end of the study. In the EPA group, the changes in SeP levels were positively correlated with the change in serum EPA levels (r = 0.709, P = 0.022). Treatment with EPA significantly enhanced %FFA but not %HGP and Rd. The change in serum EPA levels was significantly positively correlated with the change in %HGP, and negatively correlated with changes in Rd.
CONCLUSIONS


The change in serum EPA levels was positively correlated with serum SeP levels, hepatic insulin sensitivity, and negatively with skeletal muscle insulin sensitivity in humans with type 2 diabetes. The EPA-induced enhancement of hepatic insulin sensitivity might be associated with a mechanism independent of serum SeP levels.",2021,"The change in serum EPA levels were positively correlated with serum SeP levels, hepatic insulin sensitivity, and negatively skeletal muscle insulin sensitivity in humans with type 2 diabetes.","['20 participants with dyslipidemia and type 2 diabetes', 'in humans', 'humans with dyslipidemia and type 2 diabetes', 'humans with type 2 diabetes']","['polyunsaturated fatty acid eicosapentaenoic acid (EPA', 'eicosapentaenoic acid', 'stable isotope-labeled glucose infusion', 'Selenoprotein P (SeP, encoded by SELENOP', 'EPA']","['Serum SeP levels', 'serum SeP levels, hepatic insulin sensitivity, and negatively skeletal muscle insulin sensitivity', 'serum levels of selenoprotein P and organ-specific insulin sensitivity', 'SeP levels', 'organ-specific insulin sensitivity in the liver (HGP and %HGP), skeletal muscle (Rd), and adipose tissue (FFA and %FFA', 'circulating SeP levels and insulin sensitivity', 'serum EPA levels', 'change in serum SeP levels']","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0141947', 'cui_str': 'SelP Protein'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0141947', 'cui_str': 'SelP Protein'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",20.0,0.0421792,"The change in serum EPA levels were positively correlated with serum SeP levels, hepatic insulin sensitivity, and negatively skeletal muscle insulin sensitivity in humans with type 2 diabetes.","[{'ForeName': 'Yumie', 'Initials': 'Y', 'LastName': 'Takeshita', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Teramura', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Kamoshita', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Takayama', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Enyama', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Kiyo-Aki', 'Initials': 'KA', 'LastName': 'Ishii', 'Affiliation': 'Department of Integrative Medicine for Longevity, Kanazawa University Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Hisanori', 'Initials': 'H', 'LastName': 'Goto', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Nakano', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Sachie', 'Initials': 'S', 'LastName': 'Osada', 'Affiliation': 'Department of Hospital Pharmacy, Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Kumpei', 'Initials': 'K', 'LastName': 'Tokuyama', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Takamura', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13699']
2209,34656226,"Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study.","BACKGROUND


The prognosis of patients with advanced biliary tract cancer who have progressed on gemcitabine plus cisplatin is dismal. We aimed to investigate the efficacy and safety of second-line liposomal irinotecan plus fluorouracil and leucovorin in patients with metastatic biliary tract cancer that has progressed on gemcitabine plus cisplatin.
METHODS


This multicentre, open-label, randomised, phase 2b (NIFTY) study was done at five academic institutions in South Korea and included patients aged 19 years or older with histologically or cytologically confirmed metastatic biliary tract cancer that had progressed on first-line gemcitabine plus cisplatin and an Eastern Cooperative Oncology Group performance status of 0 or 1. By use of an interactive web-based response system integrated with an electronic data capture system, patients were randomly assigned (1:1) using permuted blocks (block size 4) to receive either intravenous liposomal irinotecan (70 mg/m 2  for 90 min) plus intravenous leucovorin (400 mg/m 2  for 30 min) and intravenous fluorouracil (2400 mg/m 2  for 46 h) every 2 weeks or leucovorin and fluorouracil only every 2 weeks, and were stratified by primary tumour site, previous surgery with curative intent, and participating centre. Study treatment was continued until the patient had disease progression or unacceptable toxicities, or withdrew consent. The primary endpoint was blinded independent central review (BICR)-assessed progression-free survival. The primary endpoint and safety were assessed in the full analysis set and the safety analysis set, respectively, both of which comprised all randomly assigned patients who received at least one dose of the study treatment. This trial is registered with ClinicalTrials.gov, NCT03524508, and enrolment is complete.
FINDINGS


Between Sept 5, 2018, and Feb 18, 2020, 193 patients were screened for eligibility, of whom 174 (88 in the liposomal irinotecan plus fluorouracil and leucovorin group and 86 in the fluorouracil plus leucovorin group) were enrolled and included in the full analysis and safety analysis sets. At a median follow-up of 11·8 months (IQR 7·7-18·7), the median BICR-assessed progression-free survival was significantly longer in the liposomal irinotecan plus fluorouracil and leucovorin group (7·1 months, 95% CI 3·6-8·8) than in the fluorouracil and leucovorin group (1·4 months, 1·2-1·5; hazard ratio 0·56, 95% CI 0·39-0·81; p=0·0019). The most common grade 3-4 adverse events were neutropenia (21 [24%] of 88 in the liposomal irinotecan plus fluorouracil and leucovorin group vs one [1%] of 86 in the fluorouracil and leucovorin group) and fatigue or asthenia (11 [13%] vs three [3%]). Serious adverse events occurred in 37 (42%) patients receiving liposomal irinotecan plus fluorouracil and leucovorin and 21 (24%) patients receiving fluorouracil and leucovorin. There were no treatment-related deaths.
INTERPRETATION


Adding liposomal irinotecan to fluorouracil and leucovorin significantly improved BICR-assessed progression-free survival in patients with advanced biliary tract cancer. Liposomal irinotecan plus fluorouracil and leucovorin could be considered a standard-of-care second-line therapy for advanced biliary tract cancer.
FUNDING


Servier and HK inno.
N TRANSLATION


For the Korean translation of the abstract see Supplementary Materials section.",2021,Adding liposomal irinotecan to fluorouracil and leucovorin significantly improved BICR-assessed progression-free survival in patients with advanced biliary tract cancer.,"['patients with advanced biliary tract cancer', 'and an Eastern Cooperative Oncology Group performance status of 0 or 1', 'NIFTY) study was done at five academic institutions in South Korea and included patients aged 19 years or older with histologically or cytologically confirmed metastatic biliary tract cancer that had progressed on first-line', 'patients with advanced biliary tract cancer who have progressed on', 'Between Sept 5, 2018, and Feb 18, 2020, 193 patients were screened for eligibility, of whom 174 (88 in the', 'group and 86 in the', 'advanced biliary tract cancer', 'metastatic biliary tract cancer after progression on', 'patients with metastatic biliary tract cancer']","['intravenous leucovorin', 'Liposomal irinotecan plus fluorouracil and leucovorin', 'fluorouracil and leucovorin', 'gemcitabine plus cisplatin (NIFTY', 'second-line liposomal irinotecan plus fluorouracil and leucovorin', 'leucovorin and fluorouracil', 'gemcitabine plus cisplatin', 'Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin', 'intravenous fluorouracil', 'liposomal irinotecan to fluorouracil and leucovorin', 'intravenous liposomal irinotecan', 'fluorouracil plus leucovorin', 'liposomal irinotecan plus fluorouracil and leucovorin']","['Serious adverse events', 'BICR-assessed progression-free survival', 'neutropenia', 'disease progression or unacceptable toxicities', 'fatigue or asthenia', 'central review (BICR)-assessed progression-free survival', 'efficacy and safety', 'median BICR-assessed progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C4057931', 'cui_str': 'irinotecan liposomal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",193.0,0.123172,Adding liposomal irinotecan to fluorouracil and leucovorin significantly improved BICR-assessed progression-free survival in patients with advanced biliary tract cancer.,"[{'ForeName': 'Changhoon', 'Initials': 'C', 'LastName': 'Yoo', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address: yooc@amc.seoul.kr.'}, {'ForeName': 'Kyu-Pyo', 'Initials': 'KP', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae Ho', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ilhwan', 'Initials': 'I', 'LastName': 'Kim', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Myoung Joo', 'Initials': 'MJ', 'LastName': 'Kang', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Jaekyung', 'Initials': 'J', 'LastName': 'Cheon', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Byung Woog', 'Initials': 'BW', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology/Hematology, Kyungpook National University Hospital, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Hyewon', 'Initials': 'H', 'LastName': 'Ryu', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, South Korea.'}, {'ForeName': 'Ji Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Center, Asan Institute for Life Sciences, University of Ulsan College of Medicine, Seoul, South Korea; Department of Clinical Epidemiology and Biostatistics, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyung Won', 'Initials': 'KW', 'LastName': 'Kim', 'Affiliation': 'Asan Image Metrics, Clinical Research Center, Asan Institute for Life Sciences, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Medical College at Cornell University, New York, NY, USA.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00486-1']
2210,34732357,"Efficacy of add-on Danhong injection in patients with unstable angina pectoris: A double-blind, randomized, placebo-controlled, multicenter clinical trial.","ETHNOPHARMACOLOGICAL RELEVANCE


Danhong injection (DHI)，which is extracted from Salviae miltiorrhizae and Flos carthami，has been widely prescribed to patients with unstable angina pectoris (UAP) in China. However, a high quality clinical trial is needed.
AIM OF THE STUDY


To determine whether DHI can relieve symptoms of transient myocardial ischemia in patients with unstable angina pectoris.
MATERIALS AND METHODS


A double-blind, placebo-controlled, randomized clinical trial was conducted in nine hospitals in China. Inpatients with UAP with blood stasis syndrome (BSS) were randomized 1:1 to receive DHI or placebo. The primary outcome was improvement rate in the quantification score of angina pectoris. Secondary outcomes included blood stasis syndrome scale, nitrates use, electrocardiogram recordings, PCI procedures, Seattle Angina Questionnaire (SAQ) and biochemical indexes.
RESULTS


160 participants were enrolled and 159 were analyzed. There was no significant difference in primary outcome as compared with control group at the end of 7-day treatment, but significant difference at 28-day follow up (70.53% [95% CI, 59.97-81.09%] and 54.34% [95% CI, 42.68-65.99%]; P = 0.0423). The BSS score was significantly lower in the DHI group than that in the control group at day 28 (6.49 [6.96] vs 10.53 [9.07], P = 0.0034). In addition, DHI was significantly superior to placebo in the angina stability score of SAQ (91.10 [17.37] versus 78.21 [22.08], P < 0.001). There were no significant differences in other secondary outcome measures.
CONCLUSIONS


A small decrease in the total effective rate and an increase in the angina stability score were observed 28 days after implementation of DHI in UAP with a total blood stasis syndrome score decrease, but the efficacy was not observed at day 7. The findings support that DHI may potentially relieve clinical symptoms and can benefit angina stability.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT02007187.",2021,"A small decrease in the total effective rate and an increase in the angina stability score were observed 28 days after implementation of DHI in UAP with a total blood stasis syndrome score decrease, but the efficacy was not observed at day 7.","['160 participants were enrolled and 159 were analyzed', 'patients with unstable angina pectoris (UAP) in China', 'patients with unstable angina pectoris', 'Inpatients with UAP with blood stasis syndrome (BSS', 'nine hospitals in China']","['Danhong injection', 'DHI or placebo', 'placebo', 'DHI']","['improvement rate in the quantification score of angina pectoris', 'total effective rate', 'BSS score', 'angina stability score of SAQ', 'angina stability score', 'blood stasis syndrome scale, nitrates use, electrocardiogram recordings, PCI procedures, Seattle Angina Questionnaire (SAQ) and biochemical indexes']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005750', 'cui_str': 'Blind loop syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C2715773', 'cui_str': 'danhong'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005750', 'cui_str': 'Blind loop syndrome'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",160.0,0.67872,"A small decrease in the total effective rate and an increase in the angina stability score were observed 28 days after implementation of DHI in UAP with a total blood stasis syndrome score decrease, but the efficacy was not observed at day 7.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen Nei, Beijing, 100700, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, The First Hospital of Changsha, No.311 Yingpan Road, Changsha, 410005, Hunan, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Hua', 'Affiliation': 'Department of Cardiology, Xuanwu Hospital of Capital Medical University, No. 45, Changchun Street, Beijing, 100053, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, No. 5 Haiyuncang, Beijing, 100700, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Changchun University of Chinese Medicine, No.1478 Gongnong Road, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, No.16 Airport Road, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Yu-Jie', 'Initials': 'YJ', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiology, Zhengzhou No.7 People's Hospital, No. 17, Jingnan 5th Road, Henan, 450006, China.""}, {'ForeName': 'Xi-Yan', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, First Teaching Hospital of Tianjin University of TCM, No. 314, West Anshan Road, Tianjin, 300193, China.'}, {'ForeName': 'Bai-Song', 'Initials': 'BS', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Hospital 463 of P. L. A, No. 46 Xiaoheyan Road, Shenyang, 110046, Liaoning, China.'}, {'ForeName': 'Ya-Bin', 'Initials': 'YB', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, No. 26 Heping Road, Harbin, 150040, Heilongjiang, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen Nei, Beijing, 100700, China.'}, {'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Yu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen Nei, Beijing, 100700, China.'}, {'ForeName': 'Bing-Wei', 'Initials': 'BW', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Southeast University, Dijia Qiao 87, Nanjing, 210009, Jiangsu, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, No. 5 Haiyuncang, Beijing, 100700, China. Electronic address: wx650515@163.com.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen Nei, Beijing, 100700, China. Electronic address: zhonw@vip.sina.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2021.114794']
2211,34737469,"Changing hygiene behaviours: a cluster-randomized trial, Ethiopia.","Objective


To determine whether a water, sanitation and hygiene intervention could change hygiene behaviours thought to be important for trachoma control.
Methods


We conducted a cluster-randomized trial in rural Ethiopia from 9 November 2015 to 5 March 2019. We randomized 20 clusters to an intervention consisting of water and sanitation infrastructure and hygiene promotion and 20 clusters to no intervention. All intervention clusters received a primary-school hygiene curriculum, community water point, household wash station, household soap and home visits from hygiene promotion workers. We assessed intervention fidelity through annual household surveys.
Findings


Over the 3 years, more wash stations, soap and latrines were seen at households in the intervention clusters than the control clusters: risk difference 47 percentage points (95% confidence interval, CI: 41-53) for wash stations, 18 percentage points (95% CI: 12-24) for soap and 12 percentage points (95% CI: 5-19) for latrines. A greater proportion of people in intervention clusters reported washing their faces with soap (e.g. risk difference 21 percentage points; 95% CI: 15-27 for 0-5 year-old children) and using a latrine (e.g. risk difference 9 percentage points; 95% CI: 2-15 for 6-9 year-old children). Differences between the intervention and control arms were not statistically significant for many indicators until the programme had been implemented for at least a year; they did not decline during later study visits.
Conclusion


The community- and school-based intervention was associated with improved hygiene access and behaviours, although changes in behaviour were slow and required several years of the intervention.",2021,"The community- and school-based intervention was associated with improved hygiene access and behaviours, although changes in behaviour were slow and required several years of the intervention.",['rural Ethiopia from 9 November 2015 to 5\xa0March\xa02019'],"['water, sanitation and hygiene intervention', 'water and sanitation infrastructure and hygiene promotion and 20 clusters to no intervention', 'primary-school hygiene curriculum, community water point, household wash station, household soap and home visits from hygiene promotion workers']",[],"[{'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1547959', 'cui_str': 'Wash'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],20.0,0.0833688,"The community- and school-based intervention was associated with improved hygiene access and behaviours, although changes in behaviour were slow and required several years of the intervention.","[{'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Aragie', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Wondyifraw', 'Initials': 'W', 'LastName': 'Tadesse', 'Affiliation': 'Catholic Relief Services, Addis Ababa, Ethiopia.'}, {'ForeName': 'Adane', 'Initials': 'A', 'LastName': 'Dagnew', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Dagnachew', 'Initials': 'D', 'LastName': 'Hailu', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Melese', 'Initials': 'M', 'LastName': 'Dubie', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Dionna M', 'Initials': 'DM', 'LastName': 'Wittberg', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, 490 Illinois Street, Floor 2, Box 0944, San Francisco, CA 94158, United States of America (USA).'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Melo', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, 490 Illinois Street, Floor 2, Box 0944, San Francisco, CA 94158, United States of America (USA).'}, {'ForeName': 'Mahteme', 'Initials': 'M', 'LastName': 'Haile', 'Affiliation': 'Amhara Public Health Institute, Bahir Dar, Ethiopia.'}, {'ForeName': 'Taye', 'Initials': 'T', 'LastName': 'Zeru', 'Affiliation': 'Amhara Public Health Institute, Bahir Dar, Ethiopia.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Freeman', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Nash', 'Affiliation': 'The Carter Center, Atlanta, USA.'}, {'ForeName': 'E Kelly', 'Initials': 'EK', 'LastName': 'Callahan', 'Affiliation': 'The Carter Center, Atlanta, USA.'}, {'ForeName': 'Zerihun', 'Initials': 'Z', 'LastName': 'Tadesse', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, 490 Illinois Street, Floor 2, Box 0944, San Francisco, CA 94158, United States of America (USA).'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, 490 Illinois Street, Floor 2, Box 0944, San Francisco, CA 94158, United States of America (USA).'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, 490 Illinois Street, Floor 2, Box 0944, San Francisco, CA 94158, United States of America (USA).'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, 490 Illinois Street, Floor 2, Box 0944, San Francisco, CA 94158, United States of America (USA).'}]",Bulletin of the World Health Organization,['10.2471/BLT.21.285915']
2212,34737864,"Effect of a story-based, animated video to reduce added sugar consumption: A web-based randomized controlled trial.","Background


Short and animated story-based (SAS) videos, which can be rapidly distributed through social media channels, are a novel and promising strategy for promoting health behaviors. In this study, we evaluate the effectiveness of a SAS video intervention to reduce the consumption of added sugars.
Methods


In December 2020, we randomized 4159 English-speaking participants from the United Kingdom (1:1:1) to a sugar intervention video, a content placebo video about sunscreen use (no sugar message), or a placebo video about earthquakes (no health or sugar message). We nested six list experiments in each arm and randomized participants (1:1) to a control list or a control list plus an item about consuming added sugars. The primary end-points were mean differences (on a scale of 0-100) in behavioral intent and direct restoration of freedom to consume added sugars.
Results


Participants (N = 4013) who watched the sugar video had significantly higher behavioral intent to cut their daily intake of added sugar (mean difference (md) = 16.7, 95% confidence interval (CI) = 1.5-31.8,  P  = 0.031), eat fresh fruit daily (md = 16.7, 95% CI = 0.5-32.9,  P  = 0.043), and check food labels for sugar content (md = 20.5, 95% CI = 2.6-38.5,  P  = 0.025) when compared with the sunscreen (content placebo) video. The sugar video did not arouse intent to restore freedom and consume added sugars when compared with the two placebo videos.
Conclusions


Our SAS intervention video did not arouse reactance and increased short-term behavioral intent among participants to reduce their consumption of added sugars. SAS videos, which draw on best practices from the entertainment-education media, communication theory, and the animation industry, can be an effective strategy for delivering emotionally compelling narratives to promote health behavior change.
Trial registration


German Clinical Trials Register: DRKS00022340.",2021,"Results


Participants (N = 4013) who watched the sugar video had significantly higher behavioral intent to cut their daily intake of added sugar (mean difference (md) = 16.7, 95% confidence interval (CI) = 1.5-31.8,  P  = 0.031), eat fresh fruit daily (md = 16.7, 95% CI = 0.5-32.9,  P  = 0.043), and check food labels for sugar content (md = 20.5, 95% CI = 2.6-38.5,  P  = 0.025) when compared with the sunscreen (content placebo) video.","['In December 2020, we randomized 4159 English-speaking participants from the United Kingdom (1:1:1) to a']","['control list or a control list plus an item about consuming added sugars', 'story-based, animated video to reduce added sugar consumption', 'SAS video intervention', '\n\n\nShort and animated story-based (SAS) videos', 'sugar intervention video, a content placebo video about sunscreen use (no sugar message), or a placebo video about earthquakes (no health or sugar message']","['behavioral intent and direct restoration of freedom to consume added sugars', 'behavioral intent to cut their daily intake of added sugar', 'check food labels for sugar content', 'eat fresh fruit daily']","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013463', 'cui_str': 'Earthquake'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0016475', 'cui_str': 'Food Labelling'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0453268', 'cui_str': 'Fresh fruit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",4159.0,0.251507,"Results


Participants (N = 4013) who watched the sugar video had significantly higher behavioral intent to cut their daily intake of added sugar (mean difference (md) = 16.7, 95% confidence interval (CI) = 1.5-31.8,  P  = 0.031), eat fresh fruit daily (md = 16.7, 95% CI = 0.5-32.9,  P  = 0.043), and check food labels for sugar content (md = 20.5, 95% CI = 2.6-38.5,  P  = 0.025) when compared with the sunscreen (content placebo) video.","[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vandormael', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Violetta', 'Initials': 'V', 'LastName': 'Hachaturyan', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Adam', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Favaretti', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Gates', 'Affiliation': 'Icahn School of Medicine, Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}]",Journal of global health,['10.7189/jogh.11.04064']
2213,34737863,Partnering faith leaders with community health workers increases utilization of antenatal care and facility delivery services in Ethiopia: A cluster randomized trial.,"Background


Ethiopia and other countries continue to experience high rates of maternal mortality and neonatal deaths. Interventions are needed to increase utilization of antenatal care (ANC) and facility delivery services to improve outcomes.
Methods


A cluster-randomized trial was conducted in the Amhara Region of Ethiopia, with 6 communities randomly assigned to receive the intervention and 12 communities monitored as controls. Intervention teams provided outreach to pregnant women and their families. Registry data were used to measure utilization of services provided at health centers in intervention and control communities.The intervention consisted of trained pairs of community health workers and Ethiopian Orthodox priests who worked together to promote health messages around safe delivery. The pairs visited pregnant women and their families in their homes to provide counseling, discuss concerns, and answer questions about ANC and facility deliveries. Intervention impact was measured using facility-level data on monthly number of ANC visits and facility deliveries at the health centers that served the intervention and control communities. Intervention effect was measured using difference-in-difference analyses estimated by generalized estimating equation models.
Results


During the 12-month intervention period, intervention facilities (n = 6) recorded 14% more ANC1 visits (relative risk RR = 1.14; 95% confidence interval (CI) = 1.09-1.19;  P  < 0.001) and 26% more ANC4 visits (RR = 1.26; 95%CI = 1.18, 1.34;  P  < 0.001) compared to control health centers (n = 12). The intervention health centers experienced a 10% increase in facility deliveries over what would have been expected had the intervention not occurred (RR = 1.10; 95% CI = 1.05-1.16;  P  < 0.001).
Conclusions


Promotion of safe delivery through home visits by community health workers paired with Ethiopian Orthodox priests increased utilization of ANC and facility delivery services. This approach could leverage the influential role of faith leaders and increase the impact of community health workers in Ethiopia.
Trial registration


NCT04039932.",2021,"The intervention health centers experienced a 10% increase in facility deliveries over what would have been expected had the intervention not occurred (RR = 1.10; 95% CI = 1.05-1.16;  P  < 0.001).
","['pregnant women and their families', 'Ethiopia', 'pairs visited pregnant women and their families in their homes', 'Partnering faith leaders with community health workers', 'community health workers in Ethiopia']",['trained pairs of community health workers and Ethiopian Orthodox priests who worked together to promote health messages around safe delivery'],"['facility-level data on monthly number of ANC visits and facility deliveries', 'ANC4 visits', 'facility deliveries', 'maternal mortality and neonatal deaths']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C1997140', 'cui_str': 'Ethiopian Orthodox Tewahedo, follower of religion'}, {'cui': 'C0558272', 'cui_str': 'Ordained priest'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}]",,0.0595254,"The intervention health centers experienced a 10% increase in facility deliveries over what would have been expected had the intervention not occurred (RR = 1.10; 95% CI = 1.05-1.16;  P  < 0.001).
","[{'ForeName': 'Brandon L', 'Initials': 'BL', 'LastName': 'Guthrie', 'Affiliation': 'Departments of Global Health and Epidemiology, University of Washington, Seattle, WAUSA.'}, {'ForeName': 'Adino T', 'Initials': 'AT', 'LastName': 'Tsegaye', 'Affiliation': 'Department of Epidemiology & Biostatistics, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Katherine C', 'Initials': 'KC', 'LastName': 'Rankin', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Judd L', 'Initials': 'JL', 'LastName': 'Walson', 'Affiliation': 'Departments of Global Health, Medicine, Pediatrics, and Epidemiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Getahun A', 'Initials': 'GA', 'LastName': 'Alemie', 'Affiliation': 'College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}]",Journal of global health,['10.7189/jogh.11.04063']
2214,34739763,Clinical Significance of Mean and Pulse Pressure in Patients With Heart Failure With Preserved Ejection Fraction.,"It remains debated whether pulse pressure is associated with left ventricular traits and adverse outcomes over and beyond mean arterial pressure (MAP) in patients with heart failure (HF) with preserved ejection fraction. We investigated these associations in 3428 patients with HF with preserved ejection fraction (51.5% women; mean age, 68.6 years) enrolled in the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist). We computed association sizes and hazards ratios with 1-SD increase in MAP and pulse pressure. In multivariable-adjusted analyses, association sizes ( P ≤0.039) for MAP were 0.016 cm and 0.014 cm for septal and posterior wall thickness, -0.15 for E/A ratio, -0.66 for E/e', and -0.64% for ejection fraction, independent of pulse pressure. With adjustment additionally applied for MAP, E/A ratio and longitudinal strain increased with higher pulse pressure with association sizes amounting to 0.067 ( P =0.026) and 0.40% ( P =0.023). In multivariable-adjusted analyses of both placebo and spironolactone groups, lower MAP and higher pulse pressure predicted the primary composite end point ( P ≤0.028) and hospitalized HF ( P ≤0.002), whereas MAP was also significantly associated with total mortality ( P ≤0.007). Sensitivity analyses stratified by sex, median age, and region generated confirmatory results with exception for the association of adverse outcomes with pulse pressure in patients with age ≥69 years. In conclusion, the clinical application of MAP and pulse pressure may refine risk estimates in patients with HF with preserved ejection fraction. This finding may help further investigation for the development of HF with preserved ejection fraction preventive strategies targeting pulsatility and blood pressure control.",2021,"With adjustment additionally applied for MAP, E/A ratio and longitudinal strain increased with higher pulse pressure with association sizes amounting to 0.067 ( P =0.026) and 0.40% ( P =0.023).","['patients with age ≥69 years', 'Patients With Heart Failure With Preserved Ejection Fraction', '3428 patients with HF with preserved ejection fraction (51.5% women; mean age, 68.6 years) enrolled in the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist', 'patients with heart failure (HF) with preserved ejection fraction', 'patients with HF with preserved ejection fraction']",['spironolactone'],"['hospitalized HF', 'total mortality', 'MAP and pulse pressure', 'mean arterial pressure (MAP', 'pulse pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}]",3428.0,0.150535,"With adjustment additionally applied for MAP, E/A ratio and longitudinal strain increased with higher pulse pressure with association sizes amounting to 0.067 ( P =0.026) and 0.40% ( P =0.023).","[{'ForeName': 'Fang-Fei', 'Initials': 'FF', 'LastName': 'Wei', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}, {'ForeName': 'Yuzhong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}, {'ForeName': 'Ruicong', 'Initials': 'R', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, the Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (X.L.).'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhen', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}, {'ForeName': 'Xuwei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}, {'ForeName': 'Weihao', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}, {'ForeName': 'Jiangui', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Staessen', 'Affiliation': 'Research Institute Alliance for the Promotion of Preventive Medicine, Mechelen, Belgium (J.A.S.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China (F.-F.W., Y.W., R.X., X.H., B.D., Z.Z., X.C., W.L., J.Z., J.H., Y.D., C.L.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.121.17782']
2215,34739682,Erratum to: Effectiveness and Safety Evaluation of Qixiong Zhongzi Decoction () in Idiopathic Asthenozoospermia Treatment: A Randomized Controlled Trial.,,2021,,['Idiopathic Asthenozoospermia Treatment'],['Qixiong Zhongzi Decoction '],[],"[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],[],,0.142269,,"[{'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Qing-He', 'Initials': 'QH', 'LastName': 'Gao', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Geng', 'Affiliation': 'Department of Andrology, The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Han', 'Affiliation': 'Department of Andrology, Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Jia-You', 'Initials': 'JY', 'LastName': 'Zhao', 'Affiliation': 'Graduate School, China Academy of Chinese Medical Sciences, Beijing, 100700, China.'}, {'ForeName': 'Guo-Jin', 'Initials': 'GJ', 'LastName': 'Yu', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Ji-Wei', 'Initials': 'JW', 'LastName': 'Zhang', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Chun-Sheng', 'Initials': 'CS', 'LastName': 'Song', 'Affiliation': 'Graduate School, China Academy of Chinese Medical Sciences, Beijing, 100700, China. sonchun@vip.163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-3505-4']
2216,34740110,Impact of combined consumption of fish oil and probiotics on the serum metabolome in pregnant women with overweight or obesity.,"BACKGROUND


If a pregnant woman is overweight, this can evoke metabolic alterations that may have health consequences for both mother and child.
METHODS


Pregnant women with overweight/obesity (n = 358) received fish oil+placebo, probiotics+placebo, fish oil+probiotics or placebo+placebo from early pregnancy onwards. The serum metabolome was analysed from fasting samples with a targeted NMR-approach in early and late pregnancy. GDM was diagnosed by OGTT.
FINDINGS


The intervention changed the metabolic profile of the women, but the effect was influenced by their GDM status. In women without GDM, the changes in nine lipids (FDR<0.05) in the fish oil+placebo-group differed when compared to the placebo+placebo-group. The combination of fish oil and probiotics induced changes in more metabolites, 46 of the lipid metabolites differed in women without GDM when compared to placebo+placebo-group; these included reduced increases in the concentrations and lipid constituents of VLDL-particles and less pronounced alterations in the ratios of various lipids in several lipoproteins. In women with GDM, no differences were detected in the changes of any metabolites due to any of the interventions when compared to the placebo+placebo-group (FDR<0.05).
INTERPRETATION


Fish oil and particularly the combination of fish oil and probiotics modified serum lipids in pregnant women with overweight or obesity, while no such effects were seen with probiotics alone. The effects were most evident in the lipid contents of VLDL and LDL only in women without GDM.
FUNDING


State Research Funding for university-level health research in the Turku University Hospital Expert Responsibility Area, Academy of Finland, the Diabetes Research Foundation, the Juho Vainio Foundation, Janssen Research & Development, LLC.",2021,"In women with GDM, no differences were detected in the changes of any metabolites due to any of the interventions when compared to the placebo+placebo-group (FDR<0.05).
","['Pregnant women with overweight/obesity (n\xa0=\xa0358) received', 'pregnant women with overweight or obesity', 'from early pregnancy onwards', 'pregnant woman is overweight']","['fish oil+placebo, probiotics+placebo, fish oil+probiotics or placebo+placebo', 'combined consumption of fish oil and probiotics', 'fish oil and probiotics modified serum lipids']","['concentrations and lipid constituents of VLDL-particles', 'lipid contents of VLDL and LDL', 'lipid metabolites', 'serum metabolome']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}]",,0.268043,"In women with GDM, no differences were detected in the changes of any metabolites due to any of the interventions when compared to the placebo+placebo-group (FDR<0.05).
","[{'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Mokkala', 'Affiliation': 'Institute of Biomedicine, Integrative Physiology and Pharmacology, 20014 University of Turku, Turku, Finland. Electronic address: kirsi.laitinen@utu.fi.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Vahlberg', 'Affiliation': 'Institute of Clinical Medicine, Biostatistics, 20014 University of Turku, Turku, Finland.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Houttu', 'Affiliation': 'Institute of Biomedicine, Integrative Physiology and Pharmacology, 20014 University of Turku, Turku, Finland.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Koivuniemi', 'Affiliation': 'Institute of Biomedicine, Integrative Physiology and Pharmacology, 20014 University of Turku, Turku, Finland.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Lahti', 'Affiliation': 'Department of Computing, 20014 University of Turku, Turku, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Laitinen', 'Affiliation': 'Institute of Biomedicine, Integrative Physiology and Pharmacology, 20014 University of Turku, Turku, Finland; Department of Obstetrics and Gynecology, Turku University Hospital, Kiinamyllynkatu 4-8, 20520 Turku, Finland. Electronic address: kirsi.laitinen@utu.fi.'}]",EBioMedicine,['10.1016/j.ebiom.2021.103655']
2217,34740101,Improved emotion regulation in depression following cognitive remediation: A randomized controlled trial.,"OBJECTIVE


Executive functions (EFs) play a key role in emotion regulation and, related to this, depression. Cognitive remediation (CR) targeting EFs, such as Goal Management Training (GMT) and computerized cognitive training (CCT), may reduce maladaptive emotion regulation. However, the clinical potential of GMT in the context of depression and emotion regulation remains to be tested. Hence, the primary aim of the present study was to compare effects of GMT with CCT on symptoms of emotion dysregulation.
METHOD


The paper reports the effects of a preregistered randomized controlled trial. Sixty-three participants (18-60yrs) with active or remitted depression and EF complaints were randomized to nine sessions of GMT (n = 35) or CCT (n = 28). All were assessed at baseline, post-intervention, and at 6-month follow-up. The Ruminative Response Scale and the Difficulties in Emotion Regulation Scale were employed to assess emotion regulation.
RESULTS


Both groups improved following the intervention on emotion regulation domains after controlling for intention-to-treat, including brooding rumination and on items reflecting non-accepting reactions to distress. Relative to CCT, the GMT-group demonstrated increased clarity of emotional responses in the per protocol analysis.
CONCLUSIONS


Our findings demonstrate the potential of GMT and CCT in reducing maladaptive emotion regulation in depression.",2021,"Both groups improved following the intervention on emotion regulation domains after controlling for intention-to-treat, including brooding rumination and on items reflecting non-accepting reactions to distress.",['Sixty-three participants (18-60yrs) with active or remitted depression and EF complaints'],"['Cognitive remediation (CR) targeting EFs, such as Goal Management Training (GMT) and computerized cognitive training (CCT', 'GMT', 'GMT with CCT', 'CCT', 'GMT and CCT']","['clarity of emotional responses', 'Ruminative Response Scale and the Difficulties in Emotion Regulation Scale', 'brooding rumination', 'emotion regulation', 'symptoms of emotion dysregulation', 'emotion regulation domains', 'maladaptive emotion regulation']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",63.0,0.148646,"Both groups improved following the intervention on emotion regulation domains after controlling for intention-to-treat, including brooding rumination and on items reflecting non-accepting reactions to distress.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stubberud', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway; Department of Research, Lovisenberg Diaconal Hospital, Oslo, Norway. Electronic address: Jan.stubberud@psykologi.uio.no.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Huster', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hoorelbeke', 'Affiliation': 'Department of Experimental-Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Å', 'Initials': 'Å', 'LastName': 'Hammar', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway; Division of Psychiatry, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'B I', 'Initials': 'BI', 'LastName': 'Hagen', 'Affiliation': 'Department of Research, Lovisenberg Diaconal Hospital, Oslo, Norway.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103991']
2218,34740099,Pilot randomized trial of self-guided virtual reality exposure therapy for social anxiety disorder.,"BACKGROUND


Virtual reality exposure therapy (VRE) has shown promising efficacy for the treatment of social anxiety disorder (SAD) and related comorbidities. However, most trials conducted to date were therapist-led, and little is known about the efficacy of self-guided VRE. Therefore, this randomized controlled trial (RCT) aimed to determine the efficacy of a self-directed VRE for SAD.
METHOD


Forty-four community-dwelling or undergraduate adults diagnosed with SAD based on the Mini International Neuropsychiatric Interview were randomly assigned to VRE designed to last four sessions or more (n = 26) or waitlist (WL; n = 18). Self-reported SAD severity (Social Phobia Diagnostic Questionnaire and Social Interaction Anxiety Scale), job interview anxiety (Measure of Anxiety in Selection Interviews), trait worry (Penn State Worry Questionnaire), and depression symptoms (Patient Health Questionnaire-9) were administered at baseline, post-treatment, 3-month-follow-up (3MFU), and 6-month-follow-up (6MFU). Piecewise multilevel modeling analyses were conducted to manage clustering in the data.
RESULTS


VRE vs. WL resulted in greater reductions in SAD symptom severity, job interview fear, and trait worry, with moderate-to-large effect sizes (Hedge's g = -0.54 to -1.11) from pre-to-post treatment. Although significant between-group differences did not emerge for change in depression, VRE led to change in depression, whereas waitlist did not. These gains were also maintained at 3MFU and 6MFU. Further, facets of presence increased during the course of VRE (g = 0.36-0.45), whereas cybersickness decreased (g = -0.43).
DISCUSSION


Brief, self-guided VRE might ameliorate SAD and comorbid worry, for young-to-middle-aged adults with SAD. Other theoretical and practical implications were also discussed.",2021,"RESULTS


VRE vs. WL resulted in greater reductions in SAD symptom severity, job interview fear, and trait worry, with moderate-to-large effect sizes (Hedge's g = -0.54 to -1.11) from pre-to-post treatment.","['social anxiety disorder', 'young-to-middle-aged adults with SAD', 'Forty-four community-dwelling or undergraduate adults diagnosed with SAD based on the Mini International Neuropsychiatric Interview']","['self-guided virtual reality exposure therapy', 'Virtual reality exposure therapy (VRE', 'VRE']","['SAD symptom severity, job interview fear, and trait worry, with moderate-to-large effect sizes', 'Self-reported SAD severity (Social Phobia Diagnostic Questionnaire and Social Interaction Anxiety Scale), job interview anxiety (Measure of Anxiety in Selection Interviews), trait worry (Penn State Worry Questionnaire), and depression symptoms (Patient Health Questionnaire-9']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3494470', 'cui_str': 'Virtual Reality Therapy'}]","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",44.0,0.057061,"RESULTS


VRE vs. WL resulted in greater reductions in SAD symptom severity, job interview fear, and trait worry, with moderate-to-large effect sizes (Hedge's g = -0.54 to -1.11) from pre-to-post treatment.","[{'ForeName': 'Nur Hani', 'Initials': 'NH', 'LastName': 'Zainal', 'Affiliation': 'The Pennsylvania State University, USA. Electronic address: nvz5057@psu.edu.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Chan', 'Affiliation': 'Palo Alto University, USA.'}, {'ForeName': 'Alisha P', 'Initials': 'AP', 'LastName': 'Saxena', 'Affiliation': 'Palo Alto University, USA.'}, {'ForeName': 'Craig Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Palo Alto University, USA; Stanford University, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'The Pennsylvania State University, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103984']
2219,34740074,"Effects of noise and music on situation awareness, anxiety, and the mental workload of nurses during operations.","This study aims to explore the effects of noise and music types on nurses' anxiety, mental workload and situation awareness during an operation. Participants included 20 circulating nurses (CNs) and 16 nurse anesthetists (NAs) who completed a total of 70 operations in which each operation required one CN and one NA. The experiment was separated into a control group (operating noise only) vs. an experimental group (3 different music types-between subjects and 2 music volume levels-within-subjects). Results showed that all participants had excellent situation awareness performance despite their mental workload showing significant differences in various phases of the surgery. Music at 55-60 dB caused lower mental workloads and anxiousness for nurses than those exposed to levels of 75-80 dB. When Mozart's music was played, the participants' mental workload and situation anxiety were lower than when exposed to other music types. Music played at 60 dB during an operation may be a feasible solution to mitigate the negative effects of extra noise and thus improve the nurses' performance.",2021,Results showed that all participants had excellent situation awareness performance despite their mental workload showing significant differences in various phases of the surgery.,['Participants included 20 circulating nurses (CNs) and 16 nurse anesthetists (NAs) who completed a total of 70 operations in which each operation required one CN and one NA'],"['noise and music', 'noise and music types']","[""nurses' anxiety, mental workload and situation awareness"", 'mental workloads and anxiousness for nurses', 'mental workload and situation anxiety']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1531633', 'cui_str': 'Circulating nurse'}, {'cui': 'C1321571', 'cui_str': 'Certified registered nurse anesthetist'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",20.0,0.0265381,Results showed that all participants had excellent situation awareness performance despite their mental workload showing significant differences in various phases of the surgery.,"[{'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Tseng', 'Affiliation': 'Department of Management Center, Sisters of our Lady of China Catholic Medical Foundation, St. Martin De Porres Hospital, Chiayi City, 60069, Taiwan; Department of Industrial Engineering and Management, National Yunlin University of Science and Technology, 123 University Road, Section 3, Douliu, Yunlin, 640301, Taiwan.'}, {'ForeName': 'Mao-Te', 'Initials': 'MT', 'LastName': 'Chuang', 'Affiliation': 'Department of Surgery, Sisters of our Lady of China Catholic Medical Foundation, St. Martin De Porres Hospital, Chiayi City, 60069, Taiwan.'}, {'ForeName': 'Yung-Ching', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Department of Industrial Engineering and Management, National Yunlin University of Science and Technology, 123 University Road, Section 3, Douliu, Yunlin, 640301, Taiwan. Electronic address: liuyc@yuntech.edu.tw.'}]",Applied ergonomics,['10.1016/j.apergo.2021.103633']
2220,34741023,Neoadjuvant T-DM1/pertuzumab and paclitaxel/trastuzumab/pertuzumab for HER2 +  breast cancer in the adaptively randomized I-SPY2 trial.,"HER2-targeted therapy dramatically improves outcomes in early breast cancer. Here we report the results of two HER2-targeted combinations in the neoadjuvant I-SPY2 phase 2 adaptive platform trial for early breast cancer at high risk of recurrence: ado-trastuzumab emtansine plus pertuzumab (T-DM1/P) and paclitaxel, trastuzumab and pertuzumab (THP). Eligible women have >2.5 cm clinical stage II/III HER2 +  breast cancer, adaptively randomized to T-DM1/P, THP, or a common control arm of paclitaxel/trastuzumab (TH), followed by doxorubicin/cyclophosphamide, then surgery. Both T-DM1/P and THP arms 'graduate' in all subtypes: predicted pCR rates are 63%, 72% and 33% for T-DM1/P (n = 52), THP (n = 45) and TH (n = 31) respectively. Toxicity burden is similar between arms. Degree of HER2 pathway signaling and phosphorylation in pretreatment biopsy specimens are associated with response to both T-DM1/P and THP and can further identify highly responsive HER2 +  tumors to HER2-directed therapy. This may help identify patients who can safely de-escalate cytotoxic chemotherapy without compromising excellent outcome.",2021,"Both T-DM1/P and THP arms 'graduate' in all subtypes: predicted pCR rates are 63%, 72% and 33% for T-DM1/P (n = 52), THP (n = 45) and TH (n = 31) respectively.","['early breast cancer', 'early breast cancer at high risk of recurrence', 'Eligible women have >2.5\u2009cm clinical stage II/III HER2 +  breast cancer']","['paclitaxel/trastuzumab (TH), followed by doxorubicin/cyclophosphamide', 'Neoadjuvant T-DM1/pertuzumab and paclitaxel/trastuzumab/pertuzumab', 'HER2-targeted therapy', 'THP', 'trastuzumab emtansine plus pertuzumab (T-DM1/P) and paclitaxel, trastuzumab and pertuzumab (THP']","['Toxicity burden', 'pCR rates']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205571', 'cui_str': 'Clinical stage II'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0071126', 'cui_str': 'Pirarubicin'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]",,0.158536,"Both T-DM1/P and THP arms 'graduate' in all subtypes: predicted pCR rates are 63%, 72% and 33% for T-DM1/P (n = 52), THP (n = 45) and TH (n = 31) respectively.","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Clark', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA. Amy.Clark@pennmedicine.upenn.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Yau', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Wolf', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Emanuel F', 'Initials': 'EF', 'LastName': 'Petricoin', 'Affiliation': 'George Mason University, Fairfax, VA, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': ""van 't Veer"", 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Yee', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Stacy L', 'Initials': 'SL', 'LastName': 'Moulder', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Wallace', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'A Jo', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Judy C', 'Initials': 'JC', 'LastName': 'Boughey', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University, Chicago, IL, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kemmer', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Barbara B', 'Initials': 'BB', 'LastName': 'Haley', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Hyo S', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'University of Alabama Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Elias', 'Affiliation': 'University of Colorado Denver, Aurora, CO, USA.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Lang', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Ellis', 'Affiliation': 'Swedish Cancer Institute, Seattle, WA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yung', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Debu', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'Wulfkuhle', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lamorna', 'Initials': 'L', 'LastName': 'Brown-Swigart', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Rosa I', 'Initials': 'RI', 'LastName': 'Gallagher', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Helsten', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Roesch', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'Ewing', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Alvarado', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Erin P', 'Initials': 'EP', 'LastName': 'Crane', 'Affiliation': 'Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Buxton', 'Affiliation': 'Berry Consultants, LLC, Houston, TX, USA.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Clennell', 'Affiliation': 'Berry Consultants, LLC, Houston, TX, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Paoloni', 'Affiliation': 'Berry Consultants, LLC, Houston, TX, USA.'}, {'ForeName': 'Smita M', 'Initials': 'SM', 'LastName': 'Asare', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Gillian L', 'Initials': 'GL', 'LastName': 'Hirst', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Singhrao', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Steeg', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Asare', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Matthews', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC, Houston, TX, USA.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sanil', 'Affiliation': 'Berry Consultants, LLC, Houston, TX, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Melisko', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Perlmutter', 'Affiliation': 'Gemini Group, Ann Arbor, MI, USA.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Schwab', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'W Fraser', 'Initials': 'WF', 'LastName': 'Symmans', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nola M', 'Initials': 'NM', 'LastName': 'Hylton', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC, Houston, TX, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Esserman', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'DeMichele', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}]",Nature communications,['10.1038/s41467-021-26019-y']
2221,34740932,"Efficacy of a glucagon-like peptide-1 agonist and restrictive versus liberal oxygen supply in patients undergoing coronary artery bypass grafting or aortic valve replacement: study protocol for a 2-by-2 factorial designed, randomised clinical trial.","INTRODUCTION


Coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR) are associated with risk of death, as well as brain, heart and kidney injury. Glucagon-like peptide-1 (GLP-1) analogues are approved for treatment of type 2 diabetes, and GLP-1 analogues have been suggested to have potential organ-protective and anti-inflammatory effects. During cardiopulmonary bypass (CPB), consensus on the optimal fraction of oxygen is lacking. The objective of this study is to determine the efficacy of the GLP-1-analogue exenatide versus placebo and restrictive oxygenation (50% fractional inspired oxygen, FiO2) versus liberal oxygenation (100% FiO2) in patients undergoing open heart surgery.
METHODS AND ANALYSIS


A randomised, placebo-controlled, double blind (for the exenatide intervention)/single blind (for the oxygenation strategy), 2×2 factorial designed single-centre trial on adult patients undergoing elective or subacute CABG and/or surgical AVR. Patients will be randomised in a 1:1 and 1:1 ratio to a 6-hour and 15 min infusion of 17.4 µg of exenatide or placebo during CPB and to a FiO2 of 50% or 100% during and after weaning from CPB. Patients will be followed until 12 months after inclusion of the last participant. The primary composite endpoint consists of time to first event of death, renal failure requiring renal replacement therapy, hospitalisation for stroke or heart failure. In addition, the trial will include predefined sub-studies applying more advanced measures of cardiac- and pulmonary dysfunction, renal dysfunction and cerebral dysfunction. The trial is event driven and aims at 323 primary endpoints with a projected inclusion of 1400 patients.
ETHICS AND DISSEMINATION


Eligible patients will provide informed, written consent prior to randomisation. The trial is approved by the local ethics committee and is conducted in accordance with Danish legislation and the Declaration of Helsinki. The results will be presented in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT02673931.",2021,Glucagon-like peptide-1,"['patients undergoing open heart surgery', 'adult patients undergoing elective or subacute CABG and/or surgical AVR', 'patients undergoing coronary artery bypass grafting or aortic valve replacement', '323 primary endpoints with a projected inclusion of 1400 patients']","['Coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR', 'Glucagon-like peptide-1', 'exenatide or placebo', 'placebo', 'glucagon-like peptide-1 agonist and restrictive versus liberal oxygen supply', 'GLP-1-analogue exenatide versus placebo and restrictive oxygenation (50% fractional inspired oxygen, FiO2) versus liberal oxygenation (100% FiO2']","['time to first event of death, renal failure requiring renal replacement therapy, hospitalisation for stroke or heart failure', 'cardiac- and pulmonary dysfunction, renal dysfunction and cerebral dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",,0.490957,Glucagon-like peptide-1,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Wiberg', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark Sebastian.christoph.wiberg@regionh.dk.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjaergaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Møgelvang', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christian Holdflod', 'Initials': 'CH', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiothoracic Surgery, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kandler', 'Affiliation': 'Department of Cardiothoracic Surgery, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Ravn', 'Affiliation': 'Department of Cardiothoracic Anesthesiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens Christian', 'Initials': 'JC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Cardiothoracic Anesthesiology, Rigshospitalet, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2021-052340']
2222,34742137,Early supplemental parenteral nutrition is associated with reduced mortality in critically ill surgical patients with high nutritional risk.,"BACKGROUND & AIMS


Adequate nutritional provision is important for critically ill patients to improve clinical outcomes. Starting enteral nutrition (EN) as early as possible is recommended and preferred to parenteral nutrition (PN). However, patients who undergo emergency abdominal operations may have alterations in their intra-abdominal environment and gastrointestinal motility leading to limitation in starting an enteral diet. Therefore, our study was designed to evaluate the benefit of early supplemental PN to achieve adequate calorie and protein supply in critically ill patients undergoing surgery who are not eligible for early EN.
METHODS


We reviewed the medical records of 317 patients who underwent emergency abdominal surgery for complicated intra-abdominal infection (cIAI) between January 2013 and December 2018. The nutritional data of the patients were collected for 7 days in maximum, starting on the day of intensive care unit (ICU) admission. The patients were divided by low or high malnutrition risk using the modified Nutrition Risk in Critically ill (mNUTRIC) score and body mass index. The low- and high-risk groups were subdivided into the following two categories: those who received PN within 48 h (""early"") and those who did not (""usual""). Data regarding the baseline characteristics, initial severity of illness, morbidity, and mortality rates were also obtained. The average calorie and protein supply per day were calculated in these groups.
RESULTS


Patients in all groups showed no significant differences in baseline characteristics, initial status, and infectious complications. In terms of outcomes, patients with low malnutrition risk had no significant difference in mortality. However, among patients with high malnutrition risk, the ""Early"" group had lower rates of 30-day mortality (7.6% vs. 26.7%, p = 0.006) and in-hospital mortality (13.6% vs. 28.9%, p = 0.048) than those of the ""Usual"" group. Kaplan-Meier survival curves for 30-day mortality in these groups also showed a statistically significant difference (p = 0.001). The caloric adequacy of the ""Early"" group and the ""Usual"" group were 0.88 ± 0.34 and 0.6 ± 0.29, respectively. Amounts of protein received were 0.94 ± 0.39 g/kg in the ""Early"" group and 0.47 ± 0.34 g/kg in the ""Usual"" group, respectively. There was no significant difference in infectious complications between both groups.
CONCLUSIONS


Mortality in patients with high malnutrition risk who received early PN supply within 48 h after emergency surgery for cIAI was lower than those who did not receive PN earlier. PN may be necessary to fulfill the caloric and protein requirements for critically ill patients who cannot achieve their nutritional requirements to the fullest with EN alone.",2021,Kaplan-Meier survival curves for 30-day mortality in these groups also showed a statistically significant difference (p = 0.001).,"['317 patients who underwent emergency abdominal surgery for complicated intra-abdominal infection (cIAI) between January 2013 and December 2018', 'critically ill patients undergoing surgery who are not eligible for early EN', 'patients who undergo emergency abdominal operations', 'critically ill surgical patients with high nutritional risk', 'critically ill patients who cannot achieve their nutritional requirements to the fullest with EN alone', 'patients with high malnutrition risk', 'critically ill patients']","['Starting enteral nutrition (EN', 'PN within 48\xa0h (""early"") and those who did not (""usual']","['Kaplan-Meier survival curves for 30-day mortality', 'hospital mortality', 'infectious complications', '30-day mortality', 'average calorie and protein supply per day', 'caloric adequacy', 'mortality', 'baseline characteristics, initial status, and infectious complications', 'initial severity of illness, morbidity, and mortality rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C4524048', 'cui_str': 'Complicated intra-abdominal infection'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0028719', 'cui_str': 'Nutrient requirement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0915271,Kaplan-Meier survival curves for 30-day mortality in these groups also showed a statistically significant difference (p = 0.001).,"[{'ForeName': 'Joohyun', 'Initials': 'J', 'LastName': 'Sim', 'Affiliation': 'Nutrition Support Team, Ajou University Medical Center, Republic of Korea; Department of Pediatric Surgery, Ajou University School of Medicine, Republic of Korea.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Nutrition Support Team, Ajou University Medical Center, Republic of Korea; Department of Pediatric Surgery, Ajou University School of Medicine, Republic of Korea.'}, {'ForeName': 'Eun Mi', 'Initials': 'EM', 'LastName': 'Na', 'Affiliation': 'Nutrition Support Team, Ajou University Medical Center, Republic of Korea; Department of Nursing Service, Ajou University Medical Center, Republic of Korea.'}, {'ForeName': 'Seorin', 'Initials': 'S', 'LastName': 'Doo', 'Affiliation': 'Nutrition Support Team, Ajou University Medical Center, Republic of Korea; Department of Food Service and Clinical Nutrition, Ajou University Medical Center, Republic of Korea.'}, {'ForeName': 'Yun Tae', 'Initials': 'YT', 'LastName': 'Jung', 'Affiliation': 'Department of Surgery, Gangneung Asan Hospital, University of Ulsan College of Medicine, Republic of Korea. Electronic address: paysan@ulsan.ac.kr.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.10.008']
2223,34742136,One year of omega 3 polyunsaturated fatty acid supplementation does not reduce circulating prothrombotic microvesicles in elderly subjects after suffering a myocardial infarction.,"BACKGROUND & AIMS


Circulating microvesicles (cMV) are both effectors and biomarkers of cardiovascular disease (CVD), and the effects of omega 3 polyunsaturated fatty acids (n3 PUFA) in MV shedding are not yet well known. Therefore, we aimed to investigate the effects of long-term n3 PUFA supplementation on cMV release from cells of the vascular compartment in elderly subjects at very high risk of CVD.
METHODS


We included 156 elderly patients 2-8 weeks after suffering an acute myocardial infarction from the OMEMI cohort. Subjects were randomly allocated to receive 930 mg EPA + 660 mg DHA (n3 PUFA intervention) or corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid) used as placebo daily for two years. At inclusion and after one-year follow-up, prothrombotic [annexin V (AV) + ] cMV derived from blood and vascular cells were phenotyped by flow cytometry.
RESULTS


No differences were observed in the levels of cMV between the randomized groups at inclusion in the study. After one-year follow-up, total AV + , platelet-derived CD61 + /AV + , and endothelial-derived CD31 + /AV +  and CD31 + /CD42b - /AV +  cMV increased significantly in both groups. In the n3 PUFA supplemented group, platelet-derived CD62P + /AV + , CD42b + /AV +  and CD31 + /CD42b + /AV + ; leukocyte-derived CD62L + /AV + , CD45 + /AV + , and CD11b + /AV + , as well as endothelial derived CD146 + /AV + , CD62E + /AV + , and CD309 + /AV +  cMV also increased significantly. No significant differences were however, observed in the changes of cMV levels between groups.
CONCLUSION


In elderly Norwegians who have suffered a recent acute myocardial infarction and treated as per guidelines, long-term supplementation with 1.8 g/day n3 PUFA does not modulate prothrombotic MV release from blood and vascular cells.
REGISTRATION


URL: https://www.clinicaltrials.gov; Unique identifier: NCT01841944.",2021,"In the n3 PUFA supplemented group, platelet-derived CD62P + /AV + , CD42b + /AV +  and CD31 + /CD42b + /AV + ; leukocyte-derived CD62L + /AV + , CD45 + /AV + , and CD11b + /AV + , as well as endothelial derived CD146 + /AV + , CD62E + /AV + , and CD309 + /AV +  cMV also increased significantly.","['156 elderly patients 2-8 weeks after suffering an acute myocardial infarction from the OMEMI cohort', 'elderly Norwegians who have suffered a recent acute myocardial infarction and treated as per guidelines, long-term supplementation with 1.8\xa0g/day', 'elderly subjects at very high risk of CVD', 'elderly subjects after suffering a myocardial infarction']","['platelet-derived CD62P + /AV + , CD42b + /AV +  and CD31 + /CD42b + /AV + ; leukocyte-derived CD62L + /AV + , CD45 + /AV + , and CD11b + /AV ', 'long-term n3 PUFA supplementation', 'n3 PUFA', '930\xa0mg EPA\xa0', 'DHA (n3 PUFA intervention) or corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid', 'polyunsaturated fatty acid supplementation', 'placebo']","['cMV levels', 'levels of cMV', 'circulating prothrombotic microvesicles', 'total AV + , platelet-derived CD61 + /AV + , and endothelial-derived CD31 + /AV +  and CD31 + /CD42b - /AV +  cMV']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0282604', 'cui_str': 'Lymphocyte antigen CD42b'}, {'cui': 'C0081939', 'cui_str': 'Lymphocyte antigen CD31'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0125090', 'cui_str': 'Lymphocyte antigen CD62L'}, {'cui': 'C0054961', 'cui_str': 'Lymphocyte antigen CD45'}, {'cui': 'C1136310', 'cui_str': 'Lymphocyte antigen CD11b'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}, {'cui': 'C0030234', 'cui_str': 'Palmitic acid'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0059249', 'cui_str': 'Annexin V'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0245726', 'cui_str': 'Lymphocyte antigen CD61'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0081939', 'cui_str': 'Lymphocyte antigen CD31'}]",156.0,0.0976676,"In the n3 PUFA supplemented group, platelet-derived CD62P + /AV + , CD42b + /AV +  and CD31 + /CD42b + /AV + ; leukocyte-derived CD62L + /AV + , CD45 + /AV + , and CD11b + /AV + , as well as endothelial derived CD146 + /AV + , CD62E + /AV + , and CD309 + /AV +  cMV also increased significantly.","[{'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Chiva-Blanch', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, 0450, Oslo, Norway; Department of Endocrinology and Nutrition, August Pi i Sunyer Biomedical Research Institute - IDIBAPS, Hospital Clínic of Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain; Faculty of Medicine, University of Oslo, 0372, Oslo, Norway. Electronic address: gchiva@clinic.cat.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Bratseth', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, 0450, Oslo, Norway; Faculty of Medicine, University of Oslo, 0372, Oslo, Norway.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Laake', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, 0450, Oslo, Norway; Faculty of Medicine, University of Oslo, 0372, Oslo, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Arnesen', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, 0450, Oslo, Norway; Faculty of Medicine, University of Oslo, 0372, Oslo, Norway.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Solheim', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, 0450, Oslo, Norway; Faculty of Medicine, University of Oslo, 0372, Oslo, Norway.'}, {'ForeName': 'Erik Berg', 'Initials': 'EB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Denmark.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Badimon', 'Affiliation': 'Cardiovascular Program ICCC, Institut de Recerca Hospital Santa Creu i Sant Pau-IIB Sant Pau, Barcelona, Spain; Centro de Investigación Biomédica en Red Cardiovascular (CIBERCV), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Ingebjørg', 'Initials': 'I', 'LastName': 'Seljeflot', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, 0450, Oslo, Norway; Faculty of Medicine, University of Oslo, 0372, Oslo, Norway.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.10.007']
2224,34742134,"Critical comments on the ""impact of curcumin supplementation on expression of inflammatory transcription factors in hemodialysis patients: A pilot randomized, double-blind, controlled study"" by Alvarenga.",,2021,,['hemodialysis patients'],['curcumin supplementation'],[],"[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",[],,0.573119,,"[{'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Zarezadeh', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nosrati-Oskouie', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tarighat-Esfanjani', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: tarighata@tbzmed.ac.ir.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.09.015']
2225,34742096,Baduanjin exercise ameliorates motor function in patients with post-stroke cognitive impairment: A randomized controlled trial.,"BACKGROUND AND PURPOSE


As a traditional Chinese mind-body exercise, Baduanjin has been documented to have a positive effect on cognitive and physical function in a wide range of populations, but it is unclear whether it helps improve motor function in patients with post-stroke cognitive impairment (PSCI). The aim of this two-arm, randomized, parallel controlled study was to explore the rehabilitation effect of Baduanjin exercise on motor function in patients with PSCI.
MATERIALS AND METHODS


Forty-eight patients with PSCI were randomly assigned to control and intervention groups. The control group received health education sessions on stroke prevention and rehabilitation. The intervention group received Baduanjin training in addition to the health education intervention. Before and after the 24-week intervention, both groups completed the Fugl-Meyer Assessment (FMA), Berg Balance Scale (BBS), Manual Muscle Test (MMT), Modified Ashworth Scale (MAS), and Three-Dimensional Gait Analysis (3DGA).
RESULTS


After the 24-week intervention, both groups showed significant improvements in the FMA, BBS, MMT and MAS test results, but the Baduanjin group exhibited significantly better FMA, BBS and MMT test results than the control group (all P < 0.05). Furthermore, the Baduanjin exercise group showed significant improvements in spatial gait parameters, including the step length, walking speed and cadence, which were significantly better than the control group (all P < 0.05). No adverse events were reported during the study period.
CONCLUSION


The 24-week Baduanjin exercise training may improve the limb motor function, balance, muscle strength and gait function of individuals with PSCI.",2021,"After the 24-week intervention, both groups showed significant improvements in the FMA, BBS, MMT and MAS test results, but the Baduanjin group exhibited significantly better FMA, BBS and MMT test results than the control group (all P < 0.05).","['Forty-eight patients with PSCI', 'patients with post-stroke cognitive impairment', 'patients with PSCI', 'individuals with PSCI', 'patients with post-stroke cognitive impairment (PSCI']","['Baduanjin training in addition to the health education intervention', 'Baduanjin exercise', 'health education sessions', 'Baduanjin exercise training']","['spatial gait parameters', 'adverse events', 'Fugl-Meyer Assessment (FMA), Berg Balance Scale (BBS), Manual Muscle Test (MMT), Modified Ashworth Scale (MAS), and Three-Dimensional Gait Analysis (3DGA', 'FMA, BBS and MMT test results', 'motor function', 'FMA, BBS, MMT and MAS test results', 'step length, walking speed and cadence', 'limb motor function, balance, muscle strength and gait function']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",48.0,0.0100318,"After the 24-week intervention, both groups showed significant improvements in the FMA, BBS, MMT and MAS test results, but the Baduanjin group exhibited significantly better FMA, BBS and MMT test results than the control group (all P < 0.05).","[{'ForeName': 'Mingzhu', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': 'Department of Graduate School, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China; College of Nursing and Health Management, Shanghai University of Medicine & Health Sciences, Shanghai, China. Electronic address: yzbsys@163.com.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China. Electronic address: 761363122@qq.com.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Xiong', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China. Electronic address: 624548504@qq.com.'}, {'ForeName': 'Bingzhao', 'Initials': 'B', 'LastName': 'Ye', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China. Electronic address: 949941043@qq.com.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Zheng', 'Affiliation': 'College of Nursing and Health Management, Shanghai University of Medicine & Health Sciences, Shanghai, China. Electronic address: zhenggh@sumhs.edu.cn.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101506']
2226,34742029,Rotator cuff strength is not augmented by blood flow restriction training.,"OBJECTIVE


Blood flow restriction (BFR) training utilizes a tourniquet applied to the upper or lower extremities (UE or LE) to occlude blood flow while exercising. BFR training may help augment strength in muscles that are proximal to BFR cuff application. However, prior studies have failed to demonstrate augmented strength gains in the rotator cuff when the tourniquet is applied to the UE. The purpose of this study was to evaluate if a protocol consisting of LE exercises, performed with BFR, followed by rotator cuff exercises was superior in augmenting strength, and cross-sectional area (CSA) of the rectus femoris, in untrained subjects when compared to a non-BFR training group.
DESIGN


Randomized controlled trial.
SETTING


University.
PARTICIPANTS


Thirty-five subjects (mean age 25.8 ± 1.6 y) randomized to a BFR or non-BFR group.
MAIN OUTCOME MEASURES


Muscular strength measured via hand held dynamometer and the CSA of the dominant rectus femoris was measured by diagnostic ultrasound.
RESULTS


Both groups experienced significant gains in LE and rotator cuff strength. Strength increased in the BFR group by 11.6% for the supraspinatus, 34.1% for shoulder ER, 23.4% for the quadriceps, and 17.1% for the hamstrings. Strength increased in the non-BFR group by 7.3% for the supraspinatus, 20% for shoulder ER, 12.8% for the quadriceps, and 10.7% for the hamstrings. However, there were no differences in strength gains between groups. Neither group experienced a significant increase in CSA for the rectus femoris.
CONCLUSION


The BFR protocol used in this study did not augment strength for the rotator cuff in subjects who also performed LE exercises under occlusion.",2021,"Strength increased in the BFR group by 11.6% for the supraspinatus, 34.1% for shoulder ER, 23.4% for the quadriceps, and 17.1% for the hamstrings.","['untrained subjects', 'Thirty-five subjects (mean age 25.8\xa0±', 'University']","['LE exercises', 'BFR training', 'BFR or non-BFR group']","['Muscular strength measured via hand held dynamometer and the CSA of the dominant rectus femoris was measured by diagnostic ultrasound', 'CSA for the rectus femoris', 'strength gains', 'Strength', 'LE and rotator cuff strength', 'Rotator cuff strength']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}]",35.0,0.0128072,"Strength increased in the BFR group by 11.6% for the supraspinatus, 34.1% for shoulder ER, 23.4% for the quadriceps, and 17.1% for the hamstrings.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Brumitt', 'Affiliation': 'College of Physical Therapy, George Fox University, Newberg, OR, USA, 97132. Electronic address: jbrumitt@georgefox.edu.'}, {'ForeName': 'Marcey Keefer', 'Initials': 'MK', 'LastName': 'Hutchison', 'Affiliation': 'College of Physical Therapy, George Fox University, Newberg, OR, USA, 97132. Electronic address: mkeeferhutchison@georgefox.edu.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'College of Physical Therapy, George Fox University, Newberg, OR, USA, 97132. Electronic address: dkang@georgefox.edu.'}, {'ForeName': 'Stephen Gerard D', 'Initials': 'SGD', 'LastName': 'Alterado', 'Affiliation': 'College of Physical Therapy, George Fox University, Newberg, OR, USA, 97132. Electronic address: salterado17@georgefox.edu.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Berg', 'Affiliation': 'College of Physical Therapy, George Fox University, Newberg, OR, USA, 97132. Electronic address: tberg15@georgefox.edu.'}, {'ForeName': 'Bao Phuc', 'Initials': 'BP', 'LastName': 'Nguyen', 'Affiliation': 'College of Physical Therapy, George Fox University, Newberg, OR, USA, 97132. Electronic address: bnguyen18@georgefox.edu.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Neumiller', 'Affiliation': 'College of Physical Therapy, George Fox University, Newberg, OR, USA, 97132. Electronic address: cneumiller18@georgefox.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Reynoso', 'Affiliation': 'College of Physical Therapy, George Fox University, Newberg, OR, USA, 97132. Electronic address: rreynoso18@georgefox.edu.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Stickell', 'Affiliation': 'College of Physical Therapy, George Fox University, Newberg, OR, USA, 97132. Electronic address: jstickell18@georgefox.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.10.013']
2227,34746958,Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the hepatic artery for prevention of postpancreatectomy haemorrhage: a randomized clinical trial (PANDA trial).,"BACKGROUND


Postpancreatectomy haemorrhage (PPH) is a rare but potentially fatal complication after pancreatoduodenectomy. Preventive strategies are lacking with scarce data for support. The aim of this study was to investigate whether a prophylactic falciform ligament wrap around the hepatic and gastroduodenal artery can prevent PPH from these vessels.
METHODS


In a randomized, controlled, multicentre trial, patients who were scheduled for elective open partial pancreatoduodenectomy with pancreatojejunostomy between 5 November 2015 and 2 April 2020 were randomly allocated in a 1 : 1 ratio to undergo pancreatoduodenectomy with (intervention) or without (control) a falciform ligament wrap around the hepatic artery. The primary endpoint was the rate of clinically relevant PPH from the hepatic artery or gastroduodenal artery stump within 3 months after pancreatoduodenectomy. Secondary endpoints were the rates of associated postoperative complications, for example postoperative pancreatic fistula (POPF) and PPH.
RESULTS


Altogether, 445 patients were randomized with 222 and 223 in each group. Among the patients included in modified intention-to-treat analysis (207 in the intervention group and 210 in the control group), the primary endpoint was observed in six of 207 in the intervention group compared with 15 of 210 in the control group (2.9 versus 7.1 per cent respectively; odds ratio 0.39 (95 per cent c.i. 0.15 to 1.02); P = 0.071). Per protocol analysis showed a significant reduction in the intervention group (odds ratio 0.26 (95 per cent c.i. 0.09 to 0.80); P = 0.017). A soft pancreas texture (43 per cent) and the rate of a clinically relevant POPF were evenly (20 per cent) distributed between the groups. The rate of any clinically relevant PPH including the primary endpoint and other bleeding sites was not significantly different between intervention and control groups (9.7 versus 14.8 per cent respectively).
CONCLUSION


A falciform ligament wrap may reduce PPH from the hepatic artery or gastroduodenal artery stump and should be considered during pancreatoduodenectomy. Registration number: NCT02588066 (http://www.clinicaltrials.gov).",2021,"The rate of any clinically relevant PPH including the primary endpoint and other bleeding sites was not significantly different between intervention and control groups (9.7 versus 14.8 per cent respectively).
","['patients who were scheduled for elective open partial pancreatoduodenectomy with pancreatojejunostomy between 5 November 2015 and 2 April 2020', '445 patients were randomized with 222 and 223 in each group', 'postpancreatectomy haemorrhage']","['Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the hepatic artery', 'pancreatoduodenectomy with (intervention) or without (control) a falciform ligament wrap around the hepatic artery', 'prophylactic falciform ligament wrap']","['rate of clinically relevant PPH from the hepatic artery or gastroduodenal artery stump', 'rate of a clinically relevant POPF', 'rates of associated postoperative complications, for example postoperative pancreatic fistula (POPF) and PPH', 'rate of any clinically relevant PPH', 'bleeding sites']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0230240', 'cui_str': 'Falciform ligament structure'}, {'cui': 'C0019145', 'cui_str': 'Hepatic artery'}]","[{'cui': 'C0019145', 'cui_str': 'Hepatic artery'}, {'cui': 'C0226311', 'cui_str': 'Structure of gastroduodenal artery'}, {'cui': 'C0002690', 'cui_str': 'Amputation stump'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",445.0,0.48372,"The rate of any clinically relevant PPH including the primary endpoint and other bleeding sites was not significantly different between intervention and control groups (9.7 versus 14.8 per cent respectively).
","[{'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Welsch', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Müssle', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Korn', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Dorothée', 'Initials': 'D', 'LastName': 'Sturm', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Bork', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Xina', 'Initials': 'X', 'LastName': 'Grählert', 'Affiliation': 'Coordination Centre for Clinical Trials, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Klimova', 'Affiliation': 'Core Unit for Data Management and Analytics, National Centre for Tumour Diseases (NCT), Dresden, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Trebesius', 'Affiliation': 'Department of General, Visceral, Thoracic and Oncological Surgery, Helios Amper Hospital Dachau, Dachau, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Kleespies', 'Affiliation': 'Department of General, Visceral, Thoracic and Oncological Surgery, Helios Amper Hospital Dachau, Dachau, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kees', 'Affiliation': 'Department of General, and Visceral Surgery, Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Beckert', 'Affiliation': 'Department of General, and Visceral Surgery, Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reim', 'Affiliation': 'Department of Surgery, Klinikum Rechts der Isar, School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Friess', 'Affiliation': 'Department of Surgery, Klinikum Rechts der Isar, School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Malik', 'Initials': 'M', 'LastName': 'Elwerr', 'Affiliation': 'Department of Visceral, Vascular and Endocrine Surgery, University Hospital Halle (Saale), Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Kleeff', 'Affiliation': 'Department of Visceral, Vascular and Endocrine Surgery, University Hospital Halle (Saale), Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Octavian', 'Initials': 'O', 'LastName': 'Popescu', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Klinikum Aschaffenburg-Alzenau, Aschaffenburg, Germany.'}, {'ForeName': 'Hubertus', 'Initials': 'H', 'LastName': 'Schmitz-Winnenthal', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Klinikum Aschaffenburg-Alzenau, Aschaffenburg, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Janot-Matuschek', 'Affiliation': 'Department of General and Visceral Surgery, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Uhl', 'Affiliation': 'Department of General and Visceral Surgery, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Georg F', 'Initials': 'GF', 'LastName': 'Weber', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Brunner', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Golcher', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}]",The British journal of surgery,['10.1093/bjs/znab363']
2228,34746955,Effect of 5 years of exercise training on the cardiovascular risk profile of older adults: the Generation 100 randomized trial.,"AIMS


The aim of this study was to compare the effects of 5 years of supervised exercise training (ExComb), and the differential effects of subgroups of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), with control on the cardiovascular risk profile in older adults.
METHODS AND RESULTS


Older adults aged 70-77 years from Trondheim, Norway (n = 1567, 50% women), able to safely perform exercise training were randomized to 5 years of two weekly sessions of HIIT [∼90% of peak heart rate (HR), n = 400] or MICT (∼70% of peak HR, n = 387), together forming ExComb (n = 787), or control (instructed to follow physical activity recommendations, n = 780). The main outcome was a continuous cardiovascular risk score (CCR), individual cardiovascular risk factors, and peak oxygen uptake (VO2peak). CCR was not significantly lower [-0.19, 99% confidence interval (CI) -0.46 to 0.07] and VO2peak was not significantly higher (0.39 mL/kg/min, 99% CI -0.22 to 1.00) for ExComb vs. control. HIIT showed higher VO2peak (0.76 mL/kg/min, 99% CI 0.02-1.51), but not lower CCR (-0.32, 99% CI -0.64 to 0.01) vs. control. MICT did not show significant differences compared to control or HIIT. Individual risk factors mostly did not show significant between-group differences, with some exceptions for HIIT being better than control. There was no significant effect modification by sex. The number of cardiovascular events was similar across groups. The healthy and fit study sample, and contamination and cross-over between intervention groups, challenged the possibility of detecting between-group differences.
CONCLUSIONS


Five years of supervised exercise training in older adults had little effect on cardiovascular risk profile and did not reduce cardiovascular events.
REGISTRATION


ClinicalTrials.gov: NCT01666340.",2021,"HIIT showed higher VO2peak (0.76 mL/kg/min, 99% CI 0.02-1.51), but not lower CCR (-0.32, 99% CI -0.64 to 0.01) vs. control.","['older adults', 'Older adults aged 70-77 years from Trondheim, Norway (n = 1567, 50% women), able to safely perform exercise training']","['exercise training', 'supervised exercise training (ExComb', 'MICT (∼70% of peak HR, n = 387), together forming ExComb', 'MICT', 'supervised exercise training', 'high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT']","['number of cardiovascular events', 'cardiovascular risk profile', 'CCR', 'VO2peak', 'continuous cardiovascular risk score (CCR), individual cardiovascular risk factors, and peak oxygen uptake (VO2peak']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",,0.014285,"HIIT showed higher VO2peak (0.76 mL/kg/min, 99% CI 0.02-1.51), but not lower CCR (-0.32, 99% CI -0.64 to 0.01) vs. control.","[{'ForeName': 'Jon Magne', 'Initials': 'JM', 'LastName': 'Letnes', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Berglund', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Johnson', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Dalen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Bjarne M', 'Initials': 'BM', 'LastName': 'Nes', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Hallgeir', 'Initials': 'H', 'LastName': 'Viken', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Hassel', 'Affiliation': 'Norwegian Armed Forces Occupational Health Service, Post Box 800, Lillehammer 2617, Norway.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Steinshamn', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Elisabeth Kleivhaug', 'Initials': 'EK', 'LastName': 'Vesterbekkmo', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Asbjørn', 'Initials': 'A', 'LastName': 'Støylen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Line S', 'Initials': 'LS', 'LastName': 'Reitlo', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zisko', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Fredrik H', 'Initials': 'FH', 'LastName': 'Bækkerud', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Atefe R', 'Initials': 'AR', 'LastName': 'Tari', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Ingebrigtsen', 'Affiliation': 'Department of Sociology and Political Science, Faculty of Social and Educational Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Silvana B', 'Initials': 'SB', 'LastName': 'Sandbakk', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Trude', 'Initials': 'T', 'LastName': 'Carlsen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Sigmund A', 'Initials': 'SA', 'LastName': 'Anderssen', 'Affiliation': 'Department of Sports Medicine, The Norwegian School of Sport Sciences, Sognsveien 220, Oslo 0863, Norway.'}, {'ForeName': 'Maria A Fiatarone', 'Initials': 'MAF', 'LastName': 'Singh', 'Affiliation': 'Sydney School of Health Sciences and Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, NSW 2006, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Science, University of Queensland, Human Movement Studies Building, St Lucia QLD, Queensland 4067, Australia.'}, {'ForeName': 'Jorunn L', 'Initials': 'JL', 'LastName': 'Helbostad', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Rognmo', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Wisløff', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Stensvold', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Post Box 8905, Trondheim 7491, Norway.'}]",European heart journal,['10.1093/eurheartj/ehab721']
2229,34746903,Effect of bempedoic acid plus ezetimibe fixed-dose combination vs ezetimibe or placebo on low-density lipoprotein cholesterol in patients with type 2 diabetes and hypercholesterolemia not treated with statins.,"Objective


Statins are sometimes associated with worsened glycemic control. Patients with type 2 diabetes mellitus (T2DM) may require non-statin therapies to achieve low-density lipoprotein cholesterol (LDL-C) lowering goals. This study evaluated the efficacy and safety of bempedoic acid 180 mg plus ezetimibe 10 mg fixed-dose combination (BA + EZE FDC) in patients with T2DM and hypercholesterolemia who were not receiving background statins or other lipid-lowering therapy.
Methods


Patients with T2DM and elevated LDL-C levels were enrolled into this phase 2, double-blind study (NCT03531905). Patients received placebo during a 5-week washout period where background lipid-lowering therapies (including statins) were discontinued. Eligible patients were then randomized 1:1:1 to receive either BA + EZE FDC, ezetimibe 10 mg, or placebo once daily for 12 weeks. Assessments included the percent change from baseline to week 12 in LDL-C, other lipid parameters, and high-sensitivity C-reactive protein (hsCRP); and the monitoring of safety and tolerability.
Results


Among 179 randomized patients, baseline characteristics following the washout period were similar across treatment groups, with mean LDL-C levels of 142.6 mg/dL and mean glycated hemoglobin of 8.0%. At week 12, BA + EZE FDC therapy lowered mean LDL-C levels by 38.8%, significantly more than ezetimibe alone (19.2%; difference, 19.5% [95% confidence interval (CI), 13.4%-25.7%];  p  < 0.001) or placebo (increase of 0.9%; difference, 39.6% [95% CI, 33.4%-45.8%];  p  < 0.001). BA + EZE FDC significantly reduced hsCRP levels from baseline vs ezetimibe (29.2%;  p  = 0.005) and vs placebo (36.7%;  p  < 0.001). Incidence of treatment-emergent adverse events was low in all treatment groups, with no indication of worsened glycemic control.
Conclusion


In patients with T2DM and hypercholesterolemia who were not receiving statins or other lipid-lowering drugs, BA + EZE FDC significantly lowered LDL-C levels and was generally well tolerated.",2021,"At week 12, BA + EZE FDC therapy lowered mean LDL-C levels by 38.8%, significantly more than ezetimibe alone (19.2%; difference, 19.5% [95% confidence interval (CI), 13.4%-25.7%];  p  < 0.001) or placebo (increase of 0.9%; difference, 39.6% [95% CI, 33.4%-45.8%];  p  < 0.001).","['Methods\n\n\nPatients with T2DM and elevated LDL-C levels', 'Eligible patients', 'patients with T2DM and hypercholesterolemia who were not receiving statins or other lipid-lowering drugs, BA\xa0', 'Patients with type 2 diabetes mellitus (T2DM', 'patients with type 2 diabetes and hypercholesterolemia not treated with statins', 'patients with T2DM and hypercholesterolemia who were not receiving background statins or other lipid-lowering therapy']","['BA\xa0+\xa0EZE FDC', 'BA\xa0+\xa0EZE FDC therapy', 'bempedoic acid 180\xa0mg plus ezetimibe 10\xa0mg fixed-dose combination (BA\xa0+\xa0EZE FDC', 'ezetimibe', 'EZE FDC', 'placebo', 'BA\xa0+\xa0EZE FDC, ezetimibe 10\xa0mg, or placebo', 'bempedoic acid plus ezetimibe fixed-dose combination vs ezetimibe or placebo']","['Incidence of treatment-emergent adverse events', 'tolerated', 'lipid parameters, and high-sensitivity C-reactive protein (hsCRP); and the monitoring of safety and tolerability', 'low-density lipoprotein cholesterol', 'LDL-C levels', 'hsCRP levels', 'mean LDL-C levels', 'efficacy and safety']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1166438', 'cui_str': 'ezetimibe 10 MG'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",179.0,0.163283,"At week 12, BA + EZE FDC therapy lowered mean LDL-C levels by 38.8%, significantly more than ezetimibe alone (19.2%; difference, 19.5% [95% confidence interval (CI), 13.4%-25.7%];  p  < 0.001) or placebo (increase of 0.9%; difference, 39.6% [95% CI, 33.4%-45.8%];  p  < 0.001).","[{'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Bays', 'Affiliation': 'Louisville Metabolic and Atherosclerosis Research Center, Inc., Louisville, KY, USA.'}, {'ForeName': 'Seth J', 'Initials': 'SJ', 'LastName': 'Baum', 'Affiliation': 'Excel Medical Clinical Trials, Inc., Boca Raton, FL, USA.'}, {'ForeName': 'Eliot A', 'Initials': 'EA', 'LastName': 'Brinton', 'Affiliation': 'Utah Lipid Center, Salt Lake City, UT, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Plutzky', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Hanselman', 'Affiliation': 'Esperion Therapeutics, Inc., Ann Arbor, MI, USA.'}, {'ForeName': 'Rujun', 'Initials': 'R', 'LastName': 'Teng', 'Affiliation': 'Esperion Therapeutics, Inc., Ann Arbor, MI, USA.'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}]",American journal of preventive cardiology,['10.1016/j.ajpc.2021.100278']
2230,34747368,IL-6 receptor blockade does not slow β cell loss in new-onset type 1 diabetes.,"BackgroundIL-6 receptor (IL-6R) signaling drives development of T cell populations important to type 1 diabetes pathogenesis. We evaluated whether blockade of IL-6R with monoclonal antibody tocilizumab would slow loss of residual β cell function in newly diagnosed type 1 diabetes patients.MethodsWe conducted a multicenter, randomized, placebo-controlled, double-blind trial with tocilizumab in new-onset type 1 diabetes. Participants were screened within 100 days of diagnosis. Eligible participants were randomized 2:1 to receive 7 monthly doses of tocilizumab or placebo. The primary outcome was the change from screening in the mean AUC of C-peptide collected during the first 2 hours of a mixed meal tolerance test at week 52 in pediatric participants (ages 6-17 years).ResultsThere was no statistical difference in the primary outcome between tocilizumab and placebo. Immunophenotyping showed reductions in downstream signaling of the IL-6R in T cells but no changes in CD4 memory subsets, Th17 cells, Tregs, or CD4+ T effector cell resistance to Treg suppression. A DC subset decreased during therapy but regressed to baseline once therapy stopped. Tocilizumab was well tolerated.ConclusionTocilizumab reduced T cell IL-6R signaling but did not modulate CD4+ T cell phenotypes or slow loss of residual β cell function in newly diagnosed individuals with type 1 diabetes.Trial RegistrationClinicalTrials.gov NCT02293837.FundingNIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Institute of Allergy and Infectious Diseases (NIAID) UM1AI109565, UL1TR000004 from NIH/National Center for Research Resources (NCRR) Clinical and Translational Science Award (CTSA), NIH/NIDDK P30DK036836, NIH/NIDDK U01DK103266, NIH/NIDDK U01DK103266, 1UL1TR000064 from NIH/NCRR CTSA, NIH/National Center for Advancing Translational Sciences (NCATS) UL1TR001878, UL1TR002537 from NIH/CTSA; National Health and Medical Research Council Practitioner Fellowship (APP1136735), NIH/NIDDK U01-DK085476, NIH/CTSA UL1-TR002494, Indiana Clinical and Translational Science Institute Award UL1TR002529, Vanderbilt Institute for Clinical and Translational Research UL1TR000445. NIH/NCATS UL1TR003142, NIH/CTSA program UL1-TR002494, Veteran Affairs Administration, and 1R01AI132774.",2021,"Immunophenotyping showed reductions in downstream signaling of the IL-6R in T cells but no changes in CD4 memory subsets, Th17 cells, Tregs, or CD4+ T effector cell resistance to Treg suppression.","['Eligible participants', 'newly diagnosed individuals with type 1 diabetes', 'Diabetes and Digestive and Kidney Diseases (NIDDK) and National Institute of Allergy and Infectious Diseases (NIAID', 'newly diagnosed type 1 diabetes patients', 'new-onset type 1 diabetes']","['Tocilizumab', 'tocilizumab', 'tocilizumab or placebo', 'monoclonal antibody tocilizumab', 'IL-6 receptor (IL-6R', 'tocilizumab and placebo', 'IL-6 receptor blockade', 'placebo']","['CD4 memory subsets, Th17 cells, Tregs, or CD4+ T effector cell resistance', 'tolerated', 'change from screening in the mean AUC of C-peptide']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1513898', 'cui_str': 'NIDDK'}, {'cui': 'C1513895', 'cui_str': 'National Institute of Allergy and Infectious Diseases'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C1699800', 'cui_str': 'IL6R protein, human'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C2936411', 'cui_str': 'T Helper 17 Cells'}, {'cui': 'C0312740', 'cui_str': 'Immune effector cell'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",,0.519928,"Immunophenotyping showed reductions in downstream signaling of the IL-6R in T cells but no changes in CD4 memory subsets, Th17 cells, Tregs, or CD4+ T effector cell resistance to Treg suppression.","[{'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Greenbaum', 'Affiliation': 'Center for Interventional Immunology and Diabetes Program, Benaroya Research Institute, Seattle, Washington, USA.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Serti', 'Affiliation': 'Immune Tolerance Network, Seattle, Washington, USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Lambert', 'Affiliation': 'Center for Interventional Immunology and Diabetes Program, Benaroya Research Institute, Seattle, Washington, USA.'}, {'ForeName': 'Lia J', 'Initials': 'LJ', 'LastName': 'Weiner', 'Affiliation': 'Rho, Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Kanaparthi', 'Affiliation': 'Immune Tolerance Network, Seattle, Washington, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lord', 'Affiliation': 'Center for Interventional Immunology and Diabetes Program, Benaroya Research Institute, Seattle, Washington, USA.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Gitelman', 'Affiliation': 'University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Darrell M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': 'Stanford University, Stanford, California, USA.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Gaglia', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kurt J', 'Initials': 'KJ', 'LastName': 'Griffin', 'Affiliation': 'Sanford Health, San Jose, California, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Russell', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Raskin', 'Affiliation': 'University of Texas, Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Moran', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Willi', 'Affiliation': ""Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tsalikian', 'Affiliation': 'University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'DiMeglio', 'Affiliation': ""Riley Children's Hospital, Indiana University, Indianapolis, Indiana, USA.""}, {'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Yale University, New Haven Connecticut, USA.'}, {'ForeName': 'Wayne V', 'Initials': 'WV', 'LastName': 'Moore', 'Affiliation': 'University of Missouri, Kansas City, Kansas City, Missouri, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Goland', 'Affiliation': 'Columbia University, New York, New York, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': ""Children's Health Queensland Hospital, South Brisbane, Australia.""}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': 'University of Sydney, Sydney New South Wales, Australia.'}, {'ForeName': 'Desmond A', 'Initials': 'DA', 'LastName': 'Schatz', 'Affiliation': 'University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Baidal', 'Affiliation': 'University of Miami, Coral Gables, Florida, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rodriguez', 'Affiliation': 'University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'VA Puget Sound and the University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Hendrik J', 'Initials': 'HJ', 'LastName': 'Nel', 'Affiliation': 'University of Queensland, Queensland, Brisbane, Australia.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Soppe', 'Affiliation': 'Immune Tolerance Network, Seattle, Washington, USA.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Boyle', 'Affiliation': 'Rho, Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cerosaletti', 'Affiliation': 'Center for Interventional Immunology and Diabetes Program, Benaroya Research Institute, Seattle, Washington, USA.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Keyes-Elstein', 'Affiliation': 'Rho, Inc, Durham, North Carolina, USA.'}, {'ForeName': 'S Alice', 'Initials': 'SA', 'LastName': 'Long', 'Affiliation': 'Center for Interventional Immunology and Diabetes Program, Benaroya Research Institute, Seattle, Washington, USA.'}, {'ForeName': 'Ranjeny', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'University of Queensland, Queensland, Brisbane, Australia.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'McNamara', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Jane H', 'Initials': 'JH', 'LastName': 'Buckner', 'Affiliation': 'Center for Interventional Immunology and Diabetes Program, Benaroya Research Institute, Seattle, Washington, USA.'}, {'ForeName': 'Srinath', 'Initials': 'S', 'LastName': 'Sanda', 'Affiliation': 'Immune Tolerance Network, Seattle, Washington, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JCI insight,['10.1172/jci.insight.150074']
2231,34747132,Communicating the diagnosis of cancer or depression: Results of a randomized controlled online study using video vignettes.,"BACKGROUND


Communicating a diagnosis is highly important, yet complex, especially in the context of cancer and mental disorders. The aim was to explore the communication style of an oncologist vs. psychotherapist in an online study.
METHODS


Patients (N = 136: 65 cancer, 71 depression) were randomly assigned to watch a standardized video vignette with one of two communication styles (empathic vs. unempathic). Outcome measures of affectivity, information recall, communication skills, empathy and trust were applied.
RESULTS


Regardless of diagnosis, empathic communication was associated with the perception of a significantly more empathic (p < 0.001,  η   partial   2     = 0.08) and trustworthy practitioner (p = 0.014,  η   partial   2     = 0.04) with better communication skills (p = 0.013,  η   partial   2     = 0.05). Cancer patients reported a larger decrease in positive affect (p < 0.001,  η   partial   2     = 0.15) and a larger increase in negative affect (p < 0.001,  η   partial   2     = 0.14) from pre- to post-video than depressive patients. Highly relevant information was recalled better in both groups (p < 0.001, d = 0.61-1.06).
CONCLUSIONS


The results highlight the importance of empathy while communicating both a diagnosis of cancer and a mental disorder. Further research should focus on the communication of a mental disorder in association with cancer.",2021,"Highly relevant information was recalled better in both groups (p < 0.001, d = 0.61-1.06).
","['Patients (N\xa0=\xa0136: 65 cancer, 71 depression', 'Cancer patients']",['standardized video vignette with one of two communication styles (empathic vs. unempathic'],"['affectivity, information recall, communication skills, empathy and trust were applied', 'communication skills']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]",,0.0567307,"Highly relevant information was recalled better in both groups (p < 0.001, d = 0.61-1.06).
","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Kühne', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Fauth', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Destina S', 'Initials': 'DS', 'LastName': 'Ay-Bryson', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Leonie N C', 'Initials': 'LNC', 'LastName': 'Visser', 'Affiliation': 'Center for Alzheimer Research, Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Weck', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Potsdam, Potsdam, Germany.'}]",Cancer medicine,['10.1002/cam4.4396']
2232,34747584,A Pavlovian Intervention to Condition Comforting Effects of Fruits.,"OBJECTIVE


Perceived stress, lower fruit intake, and comfort eating are all risk factors for chronic disease. The present pilot study aimed to simultaneously mitigate all three risk factors by applying Pavlovian conditioning to change the nature of comfort eating. Specifically, stressed participants underwent a Pavlovian conditioning intervention designed to elicit comforting effects of fruit intake and thereby reduce negative mood while promoting fruit intake.
METHODS


We developed a seven-dose Pavlovian conditioning intervention wherein participants temporally paired together Progressive Muscle Relaxation (unconditioned stimulus) with fruit intake (conditioned stimulus) daily for 1 week. Participants (N = 100, mean [standard deviation] age = 20.7 [4.6] years; 74% female) with moderate to high levels of baseline perceived stress were randomized to the intervention or an active explicitly unpaired control group, wherein the Progressive Muscle Relaxation and fruit intake also occurred but were not temporally paired together. After the intervention, participants' negative mood was assessed immediately before and after fruit intake to assess conditioning effects. Then, participants logged their regular food intake for 4 days using the MyFitnessPal smartphone app.
RESULTS


After the intervention, fruit intake acutely improved negative mood to a greater extent among the intervention versus control group (F(1,98) = 3.99, p = .048, = 0.039). However, there was not a significant between-group difference in intake of fruit or traditional comfort foods at postintervention.
CONCLUSIONS


Repeated pairing of fruit intake with a reliable distress-reducing activity led to the conditioning of comforting effects of fruit intake. Further refinement of the intervention design is necessary to translate this conditioned association to actual intake of fruit and other foods.",2021,"After the intervention, fruit intake acutely improved negative mood to a greater extent among the intervention versus control group (F(1,98) = 3.99, p = .048, = 0.039).","['Participants (N = 100, mean [standard deviation] age = 20.7 [4.6] years; 74% female) with moderate to high levels of baseline perceived stress']","['Fruits', 'Pavlovian conditioning intervention', 'Pavlovian conditioning intervention wherein participants temporally paired together Progressive Muscle Relaxation (unconditioned stimulus) with fruit intake (conditioned stimulus) daily for 1 week']","['intake of fruit or traditional comfort foods', 'negative mood']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009649', 'cui_str': 'Conditioning, Classical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0234403', 'cui_str': 'Unconditioned stimulus'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",100.0,0.0173581,"After the intervention, fruit intake acutely improved negative mood to a greater extent among the intervention versus control group (F(1,98) = 3.99, p = .048, = 0.039).","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Finch', 'Affiliation': 'From the Academic Research Centers (Finch), NORC at the University of Chicago, Chicago, Illinois; Social and Behavioral Sciences Branch, Division of Intramural Population Health Research (Cummings), Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Maryland; and Department of Psychology (Lee, Tomiyama), University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Cummings', 'Affiliation': ''}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'A Janet', 'Initials': 'AJ', 'LastName': 'Tomiyama', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000001008']
2233,34747583,β-Adrenergic Contributions to Emotion and Physiology During an Acute Psychosocial Stressor.,"OBJECTIVE


β-Adrenergic receptor signaling, a critical mediator of sympathetic nervous system influences on physiology and behavior, has long been proposed as one contributor to subjective stress. However, prior findings are surprisingly mixed about whether β-blockade (e.g., propranolol) blunts subjective stress, with many studies reporting no effects. We reevaluated this question in the context of an acute psychosocial stressor with more comprehensive measures and a larger-than-typical sample. We also examined the effects of β-blockade on psychophysiological indicators of sympathetic and parasympathetic nervous system reactivity, given that β-blockade effects for these measures specifically under acute psychosocial stress are not yet well established.
METHODS


In a double-blind, randomized, placebo-controlled study, 90 healthy young adults received 40 mg of the β-blocker propranolol or placebo. Participants then completed the Trier Social Stress Test, which involved completing an impromptu speech and difficult arithmetic in front of evaluative judges. Self-reported emotions and appraisals as well as psychophysiology were assessed throughout.
RESULTS


Propranolol blunted Trier Social Stress Test preejection period reactivity (b = 9.68, p = .003), a marker of sympathetic nervous system activity, as well as salivary α-amylase reactivity (b = -0.50, p = .006). Critically, propranolol also blunted negative, high arousal emotions in response to the stressor (b = -0.22, p = .026), but cognitive appraisals remained intact (b values < -0.17, p values > .10).
CONCLUSIONS


These results provide updated experimental evidence that β-adrenergic blockade attenuates negative, high arousal emotions in response to a psychosocial stressor while also blunting sympathetic nervous system reactivity. Together, these findings shed light on the neurophysiological mechanisms by which stressors transform into the subjective experience we call ""stress.""Trial Registration: ClinicalTrials.gov Identifier: NCT02972554.",2021,"RESULTS


Propranolol blunted Trier Social Stress Test preejection period reactivity (b = 9.68, p = .003), a marker of sympathetic nervous system activity, as well as salivary α-amylase reactivity (b = -0.50, p = .006).",['90 healthy young adults received 40 mg of the'],"['propranolol', 'β-blockade', 'β-blocker propranolol or placebo', 'placebo', 'Propranolol']","['blunted negative, high arousal emotions', 'marker of sympathetic nervous system activity', 'salivary α-amylase reactivity', 'blunted Trier Social Stress Test preejection period reactivity']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",90.0,0.100634,"RESULTS


Propranolol blunted Trier Social Stress Test preejection period reactivity (b = 9.68, p = .003), a marker of sympathetic nervous system activity, as well as salivary α-amylase reactivity (b = -0.50, p = .006).","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'MacCormack', 'Affiliation': 'From the Department of Psychology and Neuroscience (MacCormack, Gaudier-Diaz, Lindquist, Muscatell), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Department of Psychiatry (MacCormack), University of Pittsburgh, Pittsburgh, Pennsylvania; Graduate School of Education (Armstrong-Carter), Stanford University, Stanford, California; Department of Psychiatry (Meltzer-Brody), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Monash Institute of Pharmaceutical Sciences, Drug Discovery Biology Theme (Sloan), Monash University, Parkville; Division of Surgery (Sloan), Peter MacCallum Cancer Center, Melbourne, Victoria, Australia; Lineberger Comprehensive Cancer Center (Muscatell) and Carolina Population Center (Muscatell), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Armstrong-Carter', 'Affiliation': ''}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Gaudier-Diaz', 'Affiliation': ''}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Meltzer-Brody', 'Affiliation': ''}, {'ForeName': 'Erica K', 'Initials': 'EK', 'LastName': 'Sloan', 'Affiliation': ''}, {'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Lindquist', 'Affiliation': ''}, {'ForeName': 'Keely A', 'Initials': 'KA', 'LastName': 'Muscatell', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000001009']
2234,34747568,Differential effects of team-based learning on clinical reasoning.,"BACKGROUND


Clinical reasoning (CR) is the ability to integrate information, knowledge and contextual factors for patient care. Few studies have explored effects of team-based learning (TBL) on neurological CR. This study compared simplified TBL (sTBL) against interactive lectures (IL) for teaching CR in neuroanatomical localisation (NL) and neurological emergencies (NE), assessed using a validated Script Concordance Test (SCT).
METHODS


A crossover study was conducted with third- and fifth-year undergraduates, randomly assigned to two groups, from the Yong Loo Lin School of Medicine in Singapore. Group 1 was taught NE with sTBL and NL with IL, whereas Group 2 was taught NL with sTBL and NE with IL. Teaching was conducted sequentially over 3 h followed immediately by the SCT. The primary outcome was the difference in mean SCT scores of NE and NL taught with sTBL versus IL.
FINDINGS


A total of 179 students (Group 1, n = 81; Group 2, n = 98) participated. Mean NL SCT scores for students taught with sTBL were significantly higher compared with IL (64.8% vs. 61.7%, mean difference 3.1%, 95% confidence interval [CI] 0.6%-5.5%, p = 0.013); effect size was 0.38. Mean NE SCT scores were similar between students taught with sTBL or IL (66.6% vs. 67.0%, mean difference -0.4%, 95% CI -2.2% to 3.1%, p = 0.75).
CONCLUSIONS


sTBL was superior to IL for teaching NL, whereas both methods were comparable for teaching NE. TBL may be suitable for teaching more complex neurological topics involving diagnostic reasoning through development of problem representation, hypothesis generation and illness script selection.",2021,"Mean NL SCT scores for students taught with sTBL were significantly higher compared with IL (64.8% vs. 61.7%, mean difference 3.1%, 95% confidence interval [CI] 0.6%-5.5%, p = 0.013); effect size was 0.38.","['179 students (Group 1, n\u2009=\u200981; Group 2, n\u2009=\u200998) participated', 'third- and fifth-year undergraduates, randomly assigned to two groups, from the Yong Loo Lin School of Medicine in Singapore']","['team-based learning', 'sTBL and NE with IL', 'simplified TBL (sTBL) against interactive lectures (IL', 'TBL', 'NE with sTBL and NL with IL']","['Mean NL SCT scores', 'Mean NE SCT scores', 'mean SCT scores of NE and NL taught with sTBL versus IL']","[{'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0574448', 'cui_str': 'Lingala language'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0475264', 'cui_str': 'Localization - action'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475264', 'cui_str': 'Localization - action'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]",179.0,0.177843,"Mean NL SCT scores for students taught with sTBL were significantly higher compared with IL (64.8% vs. 61.7%, mean difference 3.1%, 95% confidence interval [CI] 0.6%-5.5%, p = 0.013); effect size was 0.38.","[{'ForeName': 'Kim Yao', 'Initials': 'KY', 'LastName': 'Ong', 'Affiliation': 'Ministry of Health Holdings, Singapore.'}, {'ForeName': 'Cherie W Q', 'Initials': 'CWQ', 'LastName': 'Ng', 'Affiliation': 'Department of Diagnostic Imaging, National University Health System, Singapore.'}, {'ForeName': 'Nigel C K', 'Initials': 'NCK', 'LastName': 'Tan', 'Affiliation': 'Office of Neurological Education, Department of Neurology, National Neuroscience Institute, Singapore.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Tan', 'Affiliation': 'Office of Neurological Education, Department of Neurology, National Neuroscience Institute, Singapore.'}]",The clinical teacher,['10.1111/tct.13436']
2235,34747567,Long-term efficacy and complications of a multicentre randomised controlled trial comparing Retropubic and Transobturator Mid-Urethral Slings: a prospective observational study.,,2021,,[],['Retropubic and Transobturator Mid-Urethral Slings'],[],[],"[{'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}]",[],,0.090111,,"[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Agur', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16982']
2236,34736497,REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain-a study protocol for a randomized controlled trial.,"BACKGROUND


Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. Scalp nerve blocks with local anesthesia seem to provide effective, safe, however, transient postoperative analgesia which does not seem to meet the requirements of craniotomy. Currently, peripheral dexamethasone has been observed to significantly prolong the duration of analgesia of nerve blocks (e.g., saphenous nerve block, adductor canal block, thoracic paravertebral block, brachial plexus nerve block). On the contrary, a study reported that perineural dexamethasone did not appear to prolong the analgesic time after supratentorial craniotomy. However, all patients in this study were given 24 mg of oral or intravenous dexamethasone regularly for at least 7 days during the perioperative period, which possibly masked the role of single local low doses of perineural dexamethasone. Therefore, the analgesic effect of single dexamethasone for scalp nerve blocks without the background of perioperative glucocorticoid deserves further clarification.
METHODS


The REDUCE trial is a prospective, single-center, parallel-group randomized controlled trial involving a total of 156 adults scheduled for elective craniotomy with general anesthesia. Patients will be randomly divided among two groups: the control group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000; the DEX 4mg  group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000. The primary outcome will be the duration of analgesia, defined as the time between the performance of the block and the first analgesic request.
DISCUSSION


The REDUCE trial aims to further assess the analgesic effect of single dexamethasone as an adjuvant to scalp nerve blocks for relief of postcraniotomy pain without the background of perioperative glucocorticoid.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04648358 . Registered on November 30, 2020.",2021,"Patients will be randomly divided among two groups: the control group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000; the DEX 4mg  group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000.",['156 adults scheduled for elective craniotomy with general anesthesia'],"['perineural dexamethasone', 'DEX 4mg  group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus 4\u2009mg dexamethasone with epinephrine', 'scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine', 'dexamethasone', 'oral or intravenous dexamethasone']","['analgesic time', 'duration of analgesia, defined as the time between the performance of the block and the first analgesic request']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}]",156.0,0.465762,"Patients will be randomly divided among two groups: the control group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000; the DEX 4mg  group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000.","[{'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Zipu', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': 'Department of Day Surgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Niti', 'Initials': 'N', 'LastName': 'Shrestha', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China. 13611326978@163.com.'}]",Trials,['10.1186/s13063-021-05747-y']
2237,34736490,Efficacy of the acupressure wrist-ankle strap in mild insomnia patients with anxiety disorders: study protocol for a randomized controlled trial.,"BACKGROUND


Insomnia is very common in current society, and patients are often accompanied by a certain degree of anxiety, depression, etc. Recent studies have found that the hypothalamic-pituitary-adrenal (HPA) axis excitement-inhibition state is an important indicator of sleep quality. Wrist-ankle acupuncture (WAA) is safe and effective for insomnia. Based on WAA theory, the acupressure wrist-ankle straps are portable WAA point compression straps that can treat diseases by automatically applying pressure to the treatment location and being operated by patients themselves. We design this trial to evaluate the clinical effect of the acupressure wrist-ankle strap in the treatment of mild insomnia patients with anxiety disorders.
METHODS/DESIGN


This trial is a parallel-design, patients-assessor blinded, randomized, sham-controlled. In total, 114 patients diagnosed with mild insomnia and anxiety disorders will be randomly assigned into two groups, the acupressure wrist-ankle strap group or the non-acupressure wrist-ankle strap group; they will receive treatments for eight weeks with five sessions each week. Rating scales, sleep monitors, and laboratory tests will be used to observe the clinical effect. From the perspective of the circadian secretion of peripheral blood-related hormones in the hypothalamic-pituitary-adrenal (HPA) axis, the possible mechanism of acupressure wrist-ankle straps for treating insomnia is studied.
DISCUSSION


The results of this study will confirm the efficacy of acupressure wrist-ankle strap in treating mild insomnia patients with anxiety disorder and whether its mechanism is related to the HPA axis. The acupressure wrist-ankle strap may become a pure physical, no side effect treatment of mild insomnia.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR2000039352 . Registered on 24 October 2020.",2021,The results of this study will confirm the efficacy of acupressure wrist-ankle strap in treating mild insomnia patients with anxiety disorder and whether its mechanism is related to the HPA axis.,"['mild insomnia patients with anxiety disorder', 'mild insomnia patients with anxiety disorders', '114 patients diagnosed with mild insomnia and anxiety disorders']","['acupressure wrist-ankle strap group or the non-acupressure wrist-ankle strap', 'acupressure wrist-ankle strap', 'Wrist-ankle acupuncture (WAA']","['Efficacy', 'Rating scales, sleep monitors, and laboratory tests']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0188910', 'cui_str': 'Strapping of ankle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]",114.0,0.114275,The results of this study will confirm the efficacy of acupressure wrist-ankle strap in treating mild insomnia patients with anxiety disorder and whether its mechanism is related to the HPA axis.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Traditional Chinese Medicine, Naval Medical University, No. 800 Xiang Ying Road, Yangpu District, Shanghai, 200433, China. m14782395536@163.com.'}, {'ForeName': 'Qinghui', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Traditional Chinese Medicine, Naval Medical University, No. 800 Xiang Ying Road, Yangpu District, Shanghai, 200433, China.'}, {'ForeName': 'Fanfu', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Department of Traditional Chinese Medicine, Naval Medical University, No. 800 Xiang Ying Road, Yangpu District, Shanghai, 200433, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Traditional Chinese Medicine, Naval Medical University, No. 800 Xiang Ying Road, Yangpu District, Shanghai, 200433, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Department of Traditional Chinese Medicine, Naval Medical University, No. 800 Xiang Ying Road, Yangpu District, Shanghai, 200433, China.'}]",Trials,['10.1186/s13063-021-05725-4']
2238,34736438,"Optimum dose of spinal ropivacaine with or without single intravenous bolus of S-ketamine during elective cesarean delivery: a randomized, double-blind, sequential dose-finding study.","BACKGROUND


Maternal hypotension after spinal anaesthesia occurs at a high rate during caesarean delivery and can lead to adverse maternal or foetal outcomes. The aim of this study was to determine the optimal dose of spinal ropivacaine for caesarean section with or without intravenous single bolus of S-ketamine and to observe the rates of hypotension associated with both methods.
METHODS


Eighty women undergoing elective caesarean delivery were randomly allocated into either a ropivacaine only or ropivacaine with intravenous S-ketamine group. If the upper sensory level of the patient reached T6 and the visual analogue scale (VAS) scores remained below 3 points before delivery, the next patient had a 1/9th chance of receiving a lower dose or an 8/9th chance of receiving the same dose as the previous patient. If the patient had VAS scores of more than 2 points or needed an extra epidural rescue bolus before delivery, a higher dose was used for the next patient. The primary outcome was the successful use of spinal ropivacaine to maintain patient VAS score of < 3 points before delivery and the incidence of post-spinal hypotension in both groups. Secondary outcomes included the rates of hypotension-related symptoms and interventions, upper sensory level of anaesthesia, level of sedation, neonatal outcomes, Edinburgh Postnatal Depression Scale scores at admission and discharge, and post-operative analgesic effect. The 90% effective dose (ED90) and 95% confidence interval (95% CI) were estimated by isotonic regression.
RESULTS


The estimated ED90 of ropivacaine was 11.8 mg (95% CI: 11.7-12.7) with and 14.7 mg (95% CI: 14.6-16.0) without intravenous S-ketamine, using biased coin up-down sequential dose-finding method. The rates of hypotension and associated symptoms were significantly lower in S-ketamine group than in the ropivacaine only group.
CONCLUSIONS


A spinal dose of ropivacaine 12 mg with a single intravenous 0.15 mg/kg bolus dose of S-ketamine may significantly reduce the risk of hypotension and induce sedation before delivery. This method may be used with appropriate caution for women undergoing elective caesarean delivery and at a high risk of hypotension or experiencing extreme nervousness.
TRIAL REGISTRATION


http://www.chictr.org.cn ( ChiCTR2000040375 ; 28/11/2020).",2021,"The rates of hypotension and associated symptoms were significantly lower in S-ketamine group than in the ropivacaine only group.
","['Eighty women undergoing elective caesarean delivery', 'elective cesarean delivery', 'women undergoing elective caesarean delivery and at a high risk of hypotension or experiencing extreme nervousness']","['spinal ropivacaine', 'ropivacaine', 'intravenous S-ketamine', 'S-ketamine', 'ketamine', 'ropivacaine only or ropivacaine with intravenous S-ketamine']","['successful use of spinal ropivacaine to maintain patient VAS score of <\u20093 points before delivery and the incidence of post-spinal hypotension', 'rates of hypotension', 'rates of hypotension and associated symptoms', 'visual analogue scale (VAS) scores', 'rates of hypotension-related symptoms and interventions, upper sensory level of anaesthesia, level of sedation, neonatal outcomes, Edinburgh Postnatal Depression Scale scores at admission and discharge, and post-operative analgesic effect', 'risk of hypotension and induce sedation', 'VAS scores']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",80.0,0.304039,"The rates of hypotension and associated symptoms were significantly lower in S-ketamine group than in the ropivacaine only group.
","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Anaesthesiology, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Henshan Road 910, Shanghai, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Henshan Road 910, Shanghai, China.'}, {'ForeName': 'Xiao-Hu', 'Initials': 'XH', 'LastName': 'An', 'Affiliation': 'Department of Anaesthesiology, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Henshan Road 910, Shanghai, China.'}, {'ForeName': 'Yu-Chieh', 'Initials': 'YC', 'LastName': 'Chao', 'Affiliation': 'Department of Anaesthesiology, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Henshan Road 910, Shanghai, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Bian', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Center Affiliated to School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Zifeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Anaesthesiology, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Henshan Road 910, Shanghai, China. xuzf@shsmu.edu.cn.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Anaesthesiology, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Henshan Road 910, Shanghai, China. towerxutao@163.com.'}]",BMC pregnancy and childbirth,['10.1186/s12884-021-04229-y']
2239,34736429,Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer.,"BACKGROUND


Long-term prospective patient-reported outcomes (PRO) after breast cancer adjuvant radiotherapy is scarce. TomoBreast compared conventional radiotherapy (CR) with tomotherapy (TT), on the hypothesis that TT might reduce lung-heart toxicity.
METHODS


Among 123 women consenting to participate, 64 were randomized to CR, 59 to TT. CR delivered 50 Gy in 25 fractions/5 weeks to breast/chest wall and regional nodes if node-positive, with a sequential boost (16 Gy/8 fractions/1.6 weeks) after lumpectomy. TT delivered 42 Gy/15 fractions/3 weeks to breast/chest wall and regional nodes if node-positive, 51 Gy simultaneous-integrated-boost in patients with lumpectomy. PRO were assessed using the European Organization for Research and Treatment of Cancer questionnaire QLQ-C30. PRO scores were converted into a symptom-free scale, 100 indicating a fully symptom-free score, 0 indicating total loss of freedom from symptom. Changes of PRO over time were analyzed using the linear mixed-effect model. Survival analysis computed time to > 10% PRO-deterioration. A post-hoc cardiorespiratory outcome was defined as deterioration in any of dyspnea, fatigue, physical functioning, or pain.
RESULTS


At 10.4 years median follow-up, patients returned on average 9 questionnaires/patient, providing a total of 1139 PRO records. Item completeness was 96.6%. Missingness did not differ between the randomization arms. The PRO at baseline were below the nominal 100% symptom-free score, notably the mean fatigue-free score was 64.8% vs. 69.6%, pain-free was 75.4% vs. 75.3%, and dyspnea-free was 84.8% vs. 88.5%, in the TT vs. CR arm, respectively, although the differences were not significant. By mixed-effect modeling on early ≤2 years assessment, all three scores deteriorated, significantly for fatigue, P ≤ 0.01, without effect of randomization arm. By modeling on late assessment beyond 2 years, TT versus CR was not significantly associated with changes of fatigue-free or pain-free scores but was associated with a significant 8.9% improvement of freedom from dyspnea, P = 0.035. By survival analysis of the time to PRO deterioration, TT improved 10-year survival free of cardiorespiratory deterioration from 66.9% with CR to 84.5% with TT, P = 0.029.
CONCLUSION


Modern radiation therapy can significantly improve long-term PRO.
TRIAL REGISTRATION


Trial registration number ClinicalTrials.gov NCT00459628 , April 12, 2007 prospectively.",2021,"By modeling on late assessment beyond 2 years, TT versus CR was not significantly associated with changes of fatigue-free or pain-free scores but was associated with a significant 8.9% improvement of freedom from dyspnea, P = 0.035.","['breast cancer', '123 women consenting to participate, 64 were randomized to CR, 59 to TT']","['conventional radiotherapy (CR) with tomotherapy (TT', 'radiation therapy', 'Modern radiation therapy']","['fatigue-free or pain-free scores', 'lung-heart toxicity', 'PRO scores', 'PRO deterioration, TT improved 10-year survival free of cardiorespiratory deterioration', 'pain-free', 'mean fatigue-free score', 'dyspnea, fatigue, physical functioning, or pain', 'dyspnea-free']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1831735', 'cui_str': 'Helical Tomotherapies'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1831735', 'cui_str': 'Helical Tomotherapies'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1831735', 'cui_str': 'Helical Tomotherapies'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",123.0,0.264523,"By modeling on late assessment beyond 2 years, TT versus CR was not significantly associated with changes of fatigue-free or pain-free scores but was associated with a significant 8.9% improvement of freedom from dyspnea, P = 0.035.","[{'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Van Parijs', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, 101 Laarbeeklaan, 1090, Brussels, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vinh-Hung', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, 101 Laarbeeklaan, 1090, Brussels, Belgium. vh@onco.be.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Fontaine', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, 101 Laarbeeklaan, 1090, Brussels, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Storme', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, 101 Laarbeeklaan, 1090, Brussels, Belgium.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Verschraegen', 'Affiliation': 'Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Dung M', 'Initials': 'DM', 'LastName': 'Nguyen', 'Affiliation': 'School of Medicine, Vietnam National University, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Adriaenssens', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, 101 Laarbeeklaan, 1090, Brussels, Belgium.'}, {'ForeName': 'Nam P', 'Initials': 'NP', 'LastName': 'Nguyen', 'Affiliation': 'Howard University, Washington, DC, USA.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Gorobets', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) de Martinique, Fort-de-France, France.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'De Ridder', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, 101 Laarbeeklaan, 1090, Brussels, Belgium.'}]",BMC cancer,['10.1186/s12885-021-08916-z']
2240,34671996,Randomised clinical trial: A phase 2 double-blind study of namodenoson in non-alcoholic fatty liver disease and steatohepatitis.,"BACKGROUND


Namodenoson, an A3 adenosine receptor (A3AR) agonist, improved liver function/pathology in non-alcoholic steatohepatitis (NASH) preclinical models.
AIM


To evaluate the efficacy and safety of namodenoson for the treatment of non-alcoholic fatty liver disease (NAFLD) with or without NASH METHODS: This phase 2 study included 60 patients with NAFLD (ALT ≥60 IU/L) who were randomised (1:1:1) to oral namodenoson 12.5 mg b.d. (n = 21), 25 mg b.d. (n = 19), or placebo (n = 20) for 12 weeks (total follow-up: 16 weeks). The main efficacy endpoint involved serum ALT after 12 weeks of treatment.
RESULTS


Serum ALT decreased over time with namodenoson in a dose-dependent manner. The difference between change from baseline (CFB) for ALT in the namodenoson 25 mg b.d. arm vs placebo trended towards significance at 12 weeks (P = 0.066). Serum AST levels also decreased with namodenoson in a dose-dependent manner; at 12 weeks, the CFB for 25 mg b.d. vs placebo was significant (P = 0.03). At Week 12, 31.6% in the namodenoson 25 mg b.d. arm and 20.0% in the placebo arm achieved ALT normalisation (P = 0.405). At week 16, the respective rates were 36.8% and 10.0% (P = 0.038). A3AR expression levels were stable over time across study arms. Both doses of namodenoson were well tolerated with no drug-emergent severe adverse events, drug-drug interactions, hepatotoxicity, or deaths. Three adverse events were considered possibly related to study treatment: myalgia (12.5 mg b.d. arm), muscular weakness (25 mg b.d. arm), and headache (25 mg b.d. arm).
CONCLUSION


A3AR is a valid target; namodenoson 25 mg b.d. was safe and demonstrated efficacy signals (ClinicalTrials.gov #NCT02927314).",2021,"Both doses of namodenoson were well tolerated with no drug-emergent severe adverse events, drug-drug interactions, hepatotoxicity, or deaths.","['non-alcoholic fatty liver disease (NAFLD', '60 patients with NAFLD (ALT ≥60\xa0IU/L', 'non-alcoholic fatty liver disease and steatohepatitis']","['oral namodenoson 12.5\xa0mg b.d', 'namodenoson', 'placebo']","['respective rates', 'Serum ALT', 'serum ALT', 'tolerated with no drug-emergent severe adverse events, drug-drug interactions, hepatotoxicity, or deaths', 'Serum AST levels', 'A3AR expression levels', 'muscular weakness', 'ALT normalisation', 'efficacy and safety', 'headache']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C2711227', 'cui_str': 'Steatohepatitis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0289969', 'cui_str': ""2-chloro-N(6)-(3-iodobenzyl)adenosine-5'-N-methyluronamide""}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0201899', 'cui_str': 'Aspartate aminotransferase measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4048326', 'cui_str': 'ADORA3 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0151786', 'cui_str': 'Muscle weakness'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",60.0,0.29054,"Both doses of namodenoson were well tolerated with no drug-emergent severe adverse events, drug-drug interactions, hepatotoxicity, or deaths.","[{'ForeName': 'Rifaat', 'Initials': 'R', 'LastName': 'Safadi', 'Affiliation': 'The Liver Unit, Hadassah Medical Organization, Hadassah Hebrew University Medical Centre, Jerusalem, Israel.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Braun', 'Affiliation': 'The Liver Institute, Rabin Medical Centre, Beilinson Hospital, Petah-Tikva, Israel.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Francis', 'Affiliation': 'Cardiology Department, Holy Family Hospital, Nazareth, Israel.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Milgrom', 'Affiliation': 'The Liver Unit, Hadassah Medical Organization, Hadassah Hebrew University Medical Centre, Jerusalem, Israel.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Massarwa', 'Affiliation': 'The Liver Unit, Hadassah Medical Organization, Hadassah Hebrew University Medical Centre, Jerusalem, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hakimian', 'Affiliation': 'The Liver Unit, Hadassah Medical Organization, Hadassah Hebrew University Medical Centre, Jerusalem, Israel.'}, {'ForeName': 'Wadi', 'Initials': 'W', 'LastName': 'Hazou', 'Affiliation': 'The Liver Unit, Hadassah Medical Organization, Hadassah Hebrew University Medical Centre, Jerusalem, Israel.'}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Issachar', 'Affiliation': 'The Liver Institute, Rabin Medical Centre, Beilinson Hospital, Petah-Tikva, Israel.'}, {'ForeName': 'Zivit', 'Initials': 'Z', 'LastName': 'Harpaz', 'Affiliation': 'Can-Fite BioPharma Ltd, Petah-Tikva, Israel.'}, {'ForeName': 'Motti', 'Initials': 'M', 'LastName': 'Farbstein', 'Affiliation': 'Can-Fite BioPharma Ltd, Petah-Tikva, Israel.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Itzhak', 'Affiliation': 'Can-Fite BioPharma Ltd, Petah-Tikva, Israel.'}, {'ForeName': 'Naama', 'Initials': 'N', 'LastName': 'Lev-Cohain', 'Affiliation': 'The Radiology Dep. Hadassah Medical Organization, Hadassah Hebrew University Medical Centre, Jerusalem, Israel.'}, {'ForeName': 'Avital', 'Initials': 'A', 'LastName': 'Bareket-Samish', 'Affiliation': 'BioInsight Ltd, Binyamina, Israel.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Silverman', 'Affiliation': 'Can-Fite BioPharma Ltd, Petah-Tikva, Israel.'}, {'ForeName': 'Pnina', 'Initials': 'P', 'LastName': 'Fishman', 'Affiliation': 'Can-Fite BioPharma Ltd, Petah-Tikva, Israel.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16664']
2241,34688931,"A commentary on ""Endoscopic versus percutaneous biliary drainage for resectable pancreatic head cancer with hyperbilirubinemia and impact on pancreaticoduodenectomy: A randomized controlled study"" [Int. J. Surg. 93 (2021 Sept 1) 106043].",,2021,,"['resectable pancreatic head cancer with hyperbilirubinemia and impact on pancreaticoduodenectomy', '93']",['Endoscopic versus percutaneous biliary drainage'],[],"[{'cui': 'C0227579', 'cui_str': 'Structure of head of pancreas'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}]",[],,0.0541513,,"[{'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Radulović', 'Affiliation': 'University College London Medical School, United Kingdom.'}, {'ForeName': 'Sharmananthan', 'Initials': 'S', 'LastName': 'Ganesananthan', 'Affiliation': 'University College London Medical School, United Kingdom. Electronic address: zchasg1@ucl.ac.uk.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Oakley', 'Affiliation': 'University College London Medical School, United Kingdom.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106144']
2242,34688917,Targeting white matter neuroprotection as a relapse prevention strategy for treatment of cocaine use disorder: Design of a mechanism-focused randomized clinical trial.,"Cocaine use continues to be a significant public health problem with limited treatment options and no approved pharmacotherapies. Cognitive-behavioral therapy (CBT) remains the mainstay treatment for preventing relapse, however, people with chronic cocaine use display cognitive impairments that are associated with poor response to CBT. Emerging evidence in animal and human studies suggests that the peroxisome proliferator-activated receptor-gamma (PPAR- γ) agonist, pioglitazone, improves white matter integrity that is essential for cognitive function. This project will determine whether adjunctive use of pioglitazone enhances the effect of CBT in preventing relapse during the early phase of recovery from cocaine use disorder. This paper describes the design of a mechanism-focused phase 2 randomized clinical trial that aims first to evaluate the effects of pioglitazone on targeted mechanisms related to white matter integrity, cognitive function, and cocaine craving; and second, to evaluate the extent to which improvements on target mechanisms predict CBT response. Positive results will support pioglitazone as a potential cognitive enhancing agent to advance to later stage medication development research.",2021,This project will determine whether adjunctive use of pioglitazone enhances the effect of CBT in preventing relapse during the early phase of recovery from cocaine use disorder.,[],"['Cognitive-behavioral therapy (CBT', 'CBT', 'pioglitazone', 'Cocaine']",[],[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]",[],,0.123479,This project will determine whether adjunctive use of pioglitazone enhances the effect of CBT in preventing relapse during the early phase of recovery from cocaine use disorder.,"[{'ForeName': 'Joy M', 'Initials': 'JM', 'LastName': 'Schmitz', 'Affiliation': 'Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, USA. Electronic address: Joy.M.Schmitz@uth.tmc.edu.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Lane', 'Affiliation': 'Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Weaver', 'Affiliation': 'Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, USA.'}, {'ForeName': 'Ponnada A', 'Initials': 'PA', 'LastName': 'Narayana', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, McGovern Medical School, University of Texas Health Science Center at Houston, USA.'}, {'ForeName': 'Khader M', 'Initials': 'KM', 'LastName': 'Hasan', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, McGovern Medical School, University of Texas Health Science Center at Houston, USA.'}, {'ForeName': 'DeLisa D', 'Initials': 'DD', 'LastName': 'Russell', 'Affiliation': 'The Right Step Houston, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Suchting', 'Affiliation': 'Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Green', 'Affiliation': 'Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, USA; Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School, University of Texas Health Science Center at Houston, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106603']
2243,34688916,A pilot study of a school lunchroom intervention in a predominately Latinx sample.,"OBJECTIVE


The purpose of the study was to assess the feasibility of an environmental school lunchroom intervention ('Smarter Lunchrooms') and test initial efficacy within a predominately Latinx population.
DESIGN


We collected baseline and intervention lunchroom food consumption and waste data in a pre-post, single group design. Meal consumption data was analyzed using Nutrition Data System for Research software to obtain estimates of nutritional content.
MAIN OUTCOME MEASURES


Feasibility.
SECONDARY MEASURES


Plate Waste, Nutrient Intake.
RESULTS


Participants were 88 1st-4th graders (51% female; 77% Latinx). Our recruitment rate was 45%, we were able to implement 8 Smarter Lunchroom strategies, and we were able to collect 82 baseline plate photos (93%) and 80 intervention photos (90%) of school lunches. On average, students threw away more than half of their meals on both days. Fruit consumption and fiber per 1000 kcal were significantly poorer at intervention compared to baseline.
CONCLUSIONS


Our findings highlight challenges in collecting consumption data in a real-world setting. We describe directions for future research taking into consideration our ""lessons learned"" from this formative work.",2021,"Fruit consumption and fiber per 1000 kcal were significantly poorer at intervention compared to baseline.
",['Participants were 88 1st-4th graders (51% female; 77% Latinx'],"['school lunchroom intervention', ""environmental school lunchroom intervention ('Smarter Lunchrooms""]",['Fruit consumption and fiber per 1000\xa0kcal'],"[{'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",,0.112126,"Fruit consumption and fiber per 1000 kcal were significantly poorer at intervention compared to baseline.
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Buscemi', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, IL, United States of America. Electronic address: jbuscem2@depaul.edu.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Clark Withington', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, IL, United States of America.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Loiacono', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, IL, United States of America.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Cory', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, IL, United States of America.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Mansfield', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, IL, United States of America.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Herman', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, IL, United States of America; Moores Cancer Center, University of California San Diego, San Diego, CA, United States of America.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Jagpal', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, IL, United States of America.'}, {'ForeName': 'Alyshia C', 'Initials': 'AC', 'LastName': 'Hamm', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, Chicago, IL, United States of America.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, Chicago, IL, United States of America; Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL, United States of America; University of Illinois at Chicago, Chicago, IL, United States of America.'}, {'ForeName': 'Danya', 'Initials': 'D', 'LastName': 'Soto', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, IL, United States of America.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Estrada', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, IL, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106599']
2244,34656202,Predictors and Moderators of Provoked Vestibulodynia Treatment Outcome Following a Randomized Trial Comparing Cognitive-Behavioral Couple Therapy to Overnight Lidocaine.,"Provoked vestibulodynia is a vulvar pain condition causing sexual dysfunction, affecting 8% to 10% of women. Our recently published randomized clinical trial (N = 108 couples) found that cognitive behavioral couple therapy (CBCT) and topical lidocaine reduced women's pain and associated sexual symptoms, with CBCT showing more benefits. Little is known about pretreatment predictors of treatment outcomes in couples sex therapy. In the current study, we examined women and their partners' pretreatment demographic (age, relationship length), clinical (pain duration, anxiety) and interpersonal (partner responses to pain, sexual goals) predictors/moderators of women's pain intensity, pain unpleasantness, and sexual function at posttreatment and 6-month follow-up. Longer relationship duration, lower anxiety in women, partner higher solicitousness and partner higher approach sexual goals predicted better pain outcomes for women with PVD irrespective of treatment condition. CBCT was more effective than lidocaine for improving women's sexual function at posttreatment when, at pretreatment, women had partners with higher anxiety and women reported lower approach sexual goals, whereas lidocaine was more effective for improving women's sexual function at follow-up when partners had higher approach sexual goals. Findings can assist clinicians in determining what treatment will be most beneficial for whom.",2021,"CBCT was more effective than lidocaine for improving women's sexual function at posttreatment when, at pretreatment, women had partners with higher anxiety and women reported lower approach sexual goals, whereas lidocaine was more effective for improving women's sexual function at follow-up when partners had higher approach sexual goals.",['couples sex therapy'],"['Provoked vestibulodynia', 'Cognitive-Behavioral Couple Therapy to Overnight Lidocaine', 'CBCT', 'cognitive behavioral couple therapy (CBCT) and topical lidocaine', 'lidocaine']","['Longer relationship duration, lower anxiety', 'pain outcomes', ""women's sexual function"", ""clinical (pain duration, anxiety) and interpersonal (partner responses to pain, sexual goals) predictors/moderators of women's pain intensity, pain unpleasantness, and sexual function""]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0302822', 'cui_str': 'Couple Therapy'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",108.0,0.0263652,"CBCT was more effective than lidocaine for improving women's sexual function at posttreatment when, at pretreatment, women had partners with higher anxiety and women reported lower approach sexual goals, whereas lidocaine was more effective for improving women's sexual function at follow-up when partners had higher approach sexual goals.","[{'ForeName': 'Natalie O', 'Initials': 'NO', 'LastName': 'Rosen', 'Affiliation': 'Dalhousie University. Electronic address: Natalie.rosen@dal.ca.'}, {'ForeName': 'Marie-Pier', 'Initials': 'MP', 'LastName': 'Vaillancourt-Morel', 'Affiliation': 'Université du Québec à Trois-Rivières.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Corsini-Munt', 'Affiliation': 'University of Ottawa.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Steben', 'Affiliation': 'Université de Montréal.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Delisle', 'Affiliation': 'Dalhousie University.'}, {'ForeName': 'Mary-Lou', 'Initials': 'ML', 'LastName': 'Baxter', 'Affiliation': 'Dalhousie University.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bergeron', 'Affiliation': 'Université de Montréal.'}]",Behavior therapy,['10.1016/j.beth.2021.05.002']
2245,34656192,"The Nature, Timing, and Symptom Trajectories of Dropout From Transdiagnostic and Single-Diagnosis Cognitive-Behavioral Therapy for Anxiety Disorders.","Dropout from psychotherapy is common and can have negative effects for patients, providers, and researchers. A better understanding of when and why patients stop treatment early, as well as actionable factors contributing to dropout, has the potential to prevent it. Here, we examined dropout from a large randomized controlled trial of transdiagnostic versus single-diagnosis cognitive-behavioral treatment (CBT) for patients with anxiety disorders (n = 179; Barlow et al., 2017). We aimed to characterize the timing of and reasons for dropout and test whether participants who dropped out had different symptom trajectories than those who completed treatment. Results indicated that overall, the greatest risk of dropout was prior to the first treatment session. In single-diagnosis CBT, dropout risk was particularly elevated before the first session and after other early sessions, whereas in transdiagnostic CBT, dropout risk was low and stable before and during treatment. Participants most often dropped out due to failure to comply with study procedures or dissatisfaction with or desiring alternative treatment. Results from multilevel models showed that trajectories of anxiety symptoms did not significantly differ between dropouts and completers. These findings suggest that there may be specific time windows for targeted and timely interventions to prevent dropout from CBT.",2021,Results from multilevel models showed that trajectories of anxiety symptoms did not significantly differ between dropouts and completers.,"['participants who dropped out had different symptom trajectories than those who completed treatment', 'patients with anxiety disorders (n\u202f=\u202f179; Barlow et al., 2017']",['transdiagnostic versus single-diagnosis cognitive-behavioral treatment (CBT'],['trajectories of anxiety symptoms'],"[{'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0220996', 'cui_str': 'Infantile scurvy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0564807,Results from multilevel models showed that trajectories of anxiety symptoms did not significantly differ between dropouts and completers.,"[{'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Bentley', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School. Electronic address: kbentley@mgh.harvard.edu.'}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Cohen', 'Affiliation': 'University of California Los Angeles.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'University of Pennsylvania.'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Bullis', 'Affiliation': 'McLean Hospital/Harvard Medical School.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Nauphal', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Cassiello-Robbins', 'Affiliation': 'Duke University Medical Center.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'University of Kentucky.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Sbi', 'Affiliation': 'Pacific University.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'University of Houston.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University.'}]",Behavior therapy,['10.1016/j.beth.2021.03.007']
2246,34656193,Treating Speech Anxiety in Youth: A Randomized Controlled Microtrial Testing the Efficacy of Exposure Only Versus Exposure Combined With Anxiety Management Strategies.,"CBT for anxious youth usually combines anxiety management strategies (AMS) with exposure, with exposure assumed to be critical for treatment success. To limit therapy time while retaining effectiveness, one might optimize CBT by restricting treatment to necessary components. This study tested whether devoting all sessions to exposure is more effective in reducing speech anxiety in youth than devoting half to AMS including cognitive or relaxation strategies and half to exposure. After a 6-week waitlist period, adolescents with speech anxiety (N = 65; age 12-15; 42 girls) were randomized to a 5-session in-school group-based CBT training consisting of either (1) exposure-only (EXP+EXP) or (2) cognitive strategies followed by exposure (COG+EXP) or (3) relaxation strategies followed by exposure (REL+EXP). Clinical interviews, speech tests, and self-report measures were assessed at pretest, posttest, and follow-up. For all conditions (a) the intervention period resulted in a stronger decline of speech anxiety than waitlist period; (b) there was a large sized reduction of speech anxiety that was maintained at six-week follow-up; (c) there was no meaningful difference in the efficacy of EXP+EXP versus COG+EXP or REL+EXP. These findings suggest that devoting all sessions to exposure is not more effective than combining exposure with AMS. AMS appeared neither necessary for CBT to be effective, nor necessary for youth to tolerate exposure. This indicates that CBT can be optimized by restricting treatment to exposure.",2021,For all conditions (a) the intervention period resulted in a stronger decline of speech anxiety than waitlist period; (b) there was a large sized reduction of speech anxiety that was maintained at six-week follow-up; (c) there was no meaningful difference in the efficacy of EXP+EXP versus COG+EXP or REL+EXP.,"['adolescents with speech anxiety (N\u202f=\u202f65; age 12-15; 42 girls', 'Treating Speech Anxiety in Youth']","['EXP+EXP', 'CBT', 'Exposure Only Versus Exposure Combined With Anxiety Management Strategies', '5-session in-school group-based CBT training consisting of either (1) exposure-only (EXP+EXP) or (2) cognitive strategies followed by exposure (COG+EXP) or (3) relaxation strategies followed by exposure (REL+EXP']","['Clinical interviews, speech tests, and self-report measures', 'speech anxiety']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0424169', 'cui_str': 'Fear of public speaking'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871652', 'cui_str': 'Management of anxiety'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424169', 'cui_str': 'Fear of public speaking'}]",65.0,0.00592875,For all conditions (a) the intervention period resulted in a stronger decline of speech anxiety than waitlist period; (b) there was a large sized reduction of speech anxiety that was maintained at six-week follow-up; (c) there was no meaningful difference in the efficacy of EXP+EXP versus COG+EXP or REL+EXP.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'de Jong', 'Affiliation': 'University of Groningen. Electronic address: r.de.jong@rug.nl.'}, {'ForeName': 'Miriam J J', 'Initials': 'MJJ', 'LastName': 'Lommen', 'Affiliation': 'University of Groningen.'}, {'ForeName': 'Marieke E', 'Initials': 'ME', 'LastName': 'Timmerman', 'Affiliation': 'University of Groningen.'}, {'ForeName': 'Wiljo J P J', 'Initials': 'WJPJ', 'LastName': 'van Hout', 'Affiliation': 'University of Groningen.'}, {'ForeName': 'Rowella C W M', 'Initials': 'RCWM', 'LastName': 'Kuijpers', 'Affiliation': 'Radboud University Nijmegen.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'de Jong', 'Affiliation': 'University of Groningen.'}, {'ForeName': 'Maaike H', 'Initials': 'MH', 'LastName': 'Nauta', 'Affiliation': 'University of Groningen.'}]",Behavior therapy,['10.1016/j.beth.2021.03.010']
2247,34656191,Treating Childhood Social Anxiety Disorder With Virtual Environments and Serious Games: A Randomized Trial.,"Disseminating efficacious psychological treatments remains a challenge for researchers and clinicians. In the case of social anxiety disorder (SAD), Social Effectiveness Therapy for Children (SET-C) has been demonstrated as an efficacious intervention, but elements of the protocol, such as peer generalization sessions, remain challenging to conduct in typical clinical settings. To address this need, we developed an artificially intelligent, web-based application, Pegasys-VR™, designed to replace peer generalization sessions and enhance homework compliance. The feasibility of Pegasys-VR™ was tested in a randomized controlled trial in comparison to SET-C. The results indicated that both programs were equally efficacious in decreasing anxiety and improving social skill in social encounters. Sixty-three percent (63%) of children treated with SET-C and 60% treated with Pegasys-VR™ did not meet diagnostic criteria for SAD at posttreatment. Pegasys-VR™ is a feasible, efficacious, and dissemination-friendly element of a comprehensive treatment program for social anxiety disorder in children.",2021,"Pegasys-VR™ is a feasible, efficacious, and dissemination-friendly element of a comprehensive treatment program for social anxiety disorder in children.","['Children (SET-C', 'social anxiety disorder in children', 'Treating Childhood Social Anxiety Disorder With Virtual Environments and Serious Games']",['Pegasys-VR'],['anxiety and improving social skill in social encounters'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0270305', 'cui_str': 'Avoidant disorder of childhood'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]",,0.0273927,"Pegasys-VR™ is a feasible, efficacious, and dissemination-friendly element of a comprehensive treatment program for social anxiety disorder in children.","[{'ForeName': 'Deborah C', 'Initials': 'DC', 'LastName': 'Beidel', 'Affiliation': 'UCF RESTORES, University of Central Florida. Electronic address: deborah.beidel@ucf.edu.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Tuerk', 'Affiliation': 'Department of Human Services, University of Virginia.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Spitalnick', 'Affiliation': 'Anxiety Specialists of Atlanta.'}, {'ForeName': 'Clint A', 'Initials': 'CA', 'LastName': 'Bowers', 'Affiliation': 'UCF RESTORES, University of Central Florida.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Morrison', 'Affiliation': 'UCF RESTORES, University of Central Florida.'}]",Behavior therapy,['10.1016/j.beth.2021.03.003']
2248,34656189,Skill Acquisition During Transdiagnostic Treatment With the Unified Protocol.,"The Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders is an emotion-focused, cognitive-behavioral intervention developed to address the full range of anxiety, depressive, and related disorders. The UP consists of core therapeutic skills that, though unique in focus, are each designed to promote an approach-oriented stance toward emotional experiences. The goal of the present investigation was to characterize changes in these skills for patients that received a course of treatment with the UP, as well as to examine associations between skills and symptoms changes. Patients with principal anxiety disorders, assigned to receive treatment with the UP (N = 88) as part of a randomized controlled trial, were included in this study. They completed validated self-report measures of UP skills (Understanding Emotions, Mindful Emotion Awareness, Cognitive Flexibility, Countering Emotional Behaviors, and Interoceptive Awareness and Tolerance), as well as clinician-rated measures of psychological symptoms. Skill measures improved significantly over the course of 12 to 16 UP treatment sessions and changes in these skills measures were associated with improvements in anxiety symptoms. Determining whether improvement on all the skills learned during a course of treatment with UP is associated with symptom remission is critical to establishing the most streamlined and efficient interventions that may ultimately be best suited to widespread dissemination.",2021,Skill measures improved significantly over the course of 12 to 16 UP treatment sessions and changes in these skills measures were associated with improvements in anxiety symptoms.,['Patients with principal anxiety disorders'],[],"['UP skills (Understanding Emotions, Mindful Emotion Awareness, Cognitive Flexibility, Countering Emotional Behaviors, and Interoceptive Awareness and Tolerance), as well as clinician-rated measures of psychological symptoms', 'Skill Acquisition', 'anxiety symptoms', 'Skill measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]",[],"[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0651523,Skill measures improved significantly over the course of 12 to 16 UP treatment sessions and changes in these skills measures were associated with improvements in anxiety symptoms.,"[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'University of Kentucky. Electronic address: ssz@uky.edu.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rosellini', 'Affiliation': 'Boston University.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Bentley', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School.'}, {'ForeName': 'Amantia A', 'Initials': 'AA', 'LastName': 'Ametaj', 'Affiliation': 'Harvard School of Public Health.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'University at Albany, State University of New York.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Cassiello-Robbins', 'Affiliation': 'Duke University Medical Center.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Wilner Tirpak', 'Affiliation': 'Boston University.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Boston University.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Boston University.'}]",Behavior therapy,['10.1016/j.beth.2021.03.001']
2249,34670131,Longitudinal study of impact of medication for opioid use disorder on Hamilton Depression Rating Scale.,"OBJECTIVE


This study aimed to evaluate the longitudinal treatment effect on depression measured by Hamilton Depression Rating Scale (HAM-D) score in a randomized clinical trial for the treatment of opioid use disorder (OUD).
METHODS


We conducted a secondary data analysis of data from the National Institute on Drug Abuse's Clinical Trials Network Protocol-0051. Patients with OUD (N = 570) were randomized to receive buprenorphine/naloxone (BUP-NX, n = 287) or extended-release naltrexone injection (XR-NTX, n = 283). The HAM-D score was completed at baseline and follow-up visit up to 36 weeks. A linear mixed model analysis was performed for log transformed HAM-D score and a generalized linear mixed model analysis was conducted for depression status.
RESULTS


Compared with BUP-NX, subjects randomized to XR-NTX had higher HAM-D scores at weeks 1 and 3 (p<0.05). There were significant interactions between treatment and visit on HAM-D score and depression status during the first four weeks of treatments in individuals without lifetime major depressive disorder (MDD). Past year cocaine use was associated with HAM-D score and depression status just in individuals without MDD, whereas past year cannabis use was associated with HAM-D score and depression status just in individuals with MDD. Past year amphetamine use was associated with HAM-D score just in individuals without MDD, however, lifetime anxiety was associated with HAM-D scores regardless of MDD.
CONCLUSION


When prescribing XR-NTX, particularly in the first month of treatment, it is essential to monitor for depressive symptoms. Screening for depression and multiple substance abuse may help clinicians identify appropriate treatment.",2021,There were significant interactions between treatment and visit on HAM-D score and depression status during the first four weeks of treatments in individuals without lifetime major depressive disorder (MDD).,['Patients with OUD (N\xa0=\xa0570'],"['XR-NTX', 'buprenorphine/naloxone (BUP-NX, n\xa0=\xa0287) or extended-release naltrexone injection (XR-NTX']","['HAM-D scores', 'depression measured by Hamilton Depression Rating Scale (HAM-D) score', 'lifetime anxiety', 'HAM-D score', 'HAM-D score and depression status', 'Hamilton Depression Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4083730', 'cui_str': 'Naltrexone Injection'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",570.0,0.0822015,There were significant interactions between treatment and visit on HAM-D score and depression status during the first four weeks of treatments in individuals without lifetime major depressive disorder (MDD).,"[{'ForeName': 'Kesheng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Family and Community Health, School of Nursing, Health Sciences Center, West Virginia University, Morgantown, WV 26506, USA. Electronic address: kesheng.wang@hsc.wvu.edu.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'DiChiacchio', 'Affiliation': 'School of Nursing, Health Sciences Center, West Virginia University, Morgantown, WV 26506, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'West Virginia Clinical and Translational Science Institute, Health Sciences Center, West Virginia University, Morgantown, WV 26506, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lander', 'Affiliation': 'Department of Behavioral Medicine and Psychiatry, School of Medicine, Rockefeller Neuroscience Institute, Morgantown, WV 26506, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Feinberg', 'Affiliation': 'Department of Behavioral Medicine and Psychiatry, School of Medicine, Rockefeller Neuroscience Institute, Morgantown, WV 26506, USA; Department of Neuroscience, West Virginia University, Morgantown, WV 26506, USA.'}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Environmental and Public Health Sciences, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Winstanley', 'Affiliation': 'Department of Behavioral Medicine and Psychiatry, School of Medicine, Rockefeller Neuroscience Institute, Morgantown, WV 26506, USA; Department of Neuroscience, West Virginia University, Morgantown, WV 26506, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Ubolrat Piamjariyakul', 'Affiliation': 'School of Nursing, Health Sciences Center, West Virginia University, Morgantown, WV 26506, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2021.10.018']
2250,34669644,Teleconsultation for preoperative evaluation during the coronavirus disease 2019 pandemic: A technical and medical feasibility study.,"BACKGROUND


During the surge in coronavirus disease 2019 (COVID-19) infections in early 2020, many medical organisations began developing strategies for implementing teleconsultation to maintain medical services during lockdown and to limit physical contact. Therefore, we developed a teleconsultation preoperative evaluation platform to replace on-site preoperative meetings.
OBJECTIVE


This study assessed the feasibility of a teleconsultation for preoperative evaluation and procedure-associated adverse events.
DESIGN


Implementation study.
SETTING


A tertiary care university hospital in Germany from April 2020 to October 2020.
PATIENTS


One hundred and eleven patients scheduled for elective surgery.
INTERVENTION


Patients were assigned to receive teleconsultation for preoperative evaluation and to complete a subsequent survey.
MAIN OUTCOME MEASURES


Primary endpoints were medical and technical feasibility, user satisfaction and time savings.
RESULTS


For 100 out of 111 patients, telepreoperative consultations allowed for adequate perioperative risk assessment, patient education and also for effective collection of legal signatures. For six patients (5.4%), consultations could not be started because of technical issues, whereas for five patients (4.8%), clearance for surgery could not be granted because of medical reasons. A clear majority of anaesthetists (93.7%) rated the telepreoperative evaluations as equivalent to on-site meetings. The majority of the patients considered teleconsultation for preoperative evaluation as convenient as an on-site meeting (98.2%) and would choose a teleconsultation again (97.9%). Median travel time saved by patients was 60 min (Q1 40, Q3 80). We registered one adverse event: we detected atrial fibrillation in one patient only immediately prior to surgery.
CONCLUSION


Telepreoperative evaluations are medically and technically feasible, yielding high satisfaction rates on both sides. However, regarding patient safety, not every patient is equally well suited. Overall, implementation of teleconsultation for preoperative evaluation into clinical routine could help maintain medical care during the COVID-19 pandemic.
TRIAL REGISTRATION


NCT04518514, ClinicalTrials.gov.",2021,A clear majority of anaesthetists (93.7%) rated the telepreoperative evaluations as equivalent to on-site meetings.,"['One hundred and eleven patients scheduled for elective surgery', 'A tertiary care university hospital in Germany from April 2020 to October 2020']",[],"['Median travel time saved', 'medical and technical feasibility, user satisfaction and time savings', 'atrial fibrillation']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",111.0,0.111104,A clear majority of anaesthetists (93.7%) rated the telepreoperative evaluations as equivalent to on-site meetings.,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wienhold', 'Affiliation': 'From the Department of Anaesthesiology (JW, LM, RR, MD, MC, AF) and Legal Affairs Division, University Hospital RWTH Aachen, Aachen, Germany (IK).'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Mösch', 'Affiliation': ''}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Rossaint', 'Affiliation': ''}, {'ForeName': 'Ilka', 'Initials': 'I', 'LastName': 'Kemper', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Derwall', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Czaplik', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Follmann', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001616']
2251,34747791,Effect of Yogasanas Versus Gaze Stability and Habituation Exercises on Dizziness in Vestibular Dysfunction.,"Background


Dizziness is a typical manifestation of vestibular pathologies. Clinical studies have shown that it affects 1.82% of young adults to more than 30% older adults. Habituation and compensation are some traditional rehabilitation protocols.
Objective


Yoga is also known to have a significant effect on vestibulopathy. Hence, a need arises to compare the above two maneuvers.
Materials and Methods


Participants were recruited (n = 32) after screening using the Dix-Hallpike and head impulse test. They were then divided into two groups (n = 16). The first one, Group A, received yogasanas, and the second one, Group B, received gaze stabilization and habituation exercises for 4 days a week for 3 weeks. Pre- and post intervention outcome measures were taken using the motion sensitivity quotient (MSQ) score and Dizziness Handicap Inventory (DHI) scale.
Results


In reducing symptoms of dizziness, the between-group comparison shows that Group A has shown greater improvement (12.37% ±1.43%) in MSQ and Group B has shown greater improvement (16.12 ± 3.56) in DHI. Within-group comparison shows that both the interventions are effective in reducing symptoms of dizziness (P < 0.05).
Conclusion


Both gaze stabilization along with habituation exercises and yogasanas are effective in improving the symptoms of dizziness in patients with peripheral vestibular dysfunction. When compared between the groups, yogasanas had a superior hand in the MSQ score, whereas gaze stabilization and habituation exercises had a superior hand in the DHI scale.",2021,Both gaze stabilization along with habituation exercises and yogasanas are effective in improving the symptoms of dizziness in patients with peripheral vestibular dysfunction.,"['patients with peripheral vestibular dysfunction', 'young adults to more than 30% older adults', 'Dizziness in Vestibular Dysfunction', 'Materials and Methods\n\n\nParticipants were recruited (n = 32) after screening using the Dix-Hallpike and head impulse test']","['gaze stabilization and habituation exercises', 'Pre- and post intervention', 'Yogasanas Versus Gaze Stability and Habituation Exercises', 'habituation exercises']","['gaze stabilization and habituation exercises', 'DHI scale', 'motion sensitivity quotient (MSQ) score and Dizziness Handicap Inventory (DHI) scale', 'symptoms of dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3658201', 'cui_str': 'Head impulse test'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",32.0,0.0203056,Both gaze stabilization along with habituation exercises and yogasanas are effective in improving the symptoms of dizziness in patients with peripheral vestibular dysfunction.,"[{'ForeName': 'Preeti S', 'Initials': 'PS', 'LastName': 'Gazbare', 'Affiliation': 'Neurophysiotherapy Department, Dr D.Y Patil College of Physiotherapy, Dr D.Y Patil Vidyapeeth, Pune, India.'}, {'ForeName': 'Namrata D', 'Initials': 'ND', 'LastName': 'Rawtani', 'Affiliation': 'Neurophysiotherapy Department, Dr D.Y Patil College of Physiotherapy, Dr D.Y Patil Vidyapeeth, Pune, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Rathi', 'Affiliation': 'Community Based Rehabilitation Department, Dr D.Y Patil College of Physiotherapy, Dr D.Y Patil Vidyapeeth, Pune, India.'}, {'ForeName': 'Tushar J', 'Initials': 'TJ', 'LastName': 'Palekar', 'Affiliation': 'Principal, Dr D.Y Patil College of Physiotherapy, Dr D.Y Patil Vidyapeeth, Pune, India.'}]",Neurology India,['10.4103/0028-3886.329557']
2252,34747712,Investigating the Use of a Serious Game to Improve Opioid Safety Awareness Among Adolescents: A Quantitative Study.,"BACKGROUND


The misuse of opioid medications among adolescents is a serious problem in the United States. Serious games (SGs) are a novel way to promote safe and responsible management of opioid medications among adolescents, thereby reducing the number of adolescent opioid misuse cases reported annually.
OBJECTIVE


This study aimed to examine the effect of the SG MedSMA℞T: Adventures in PharmaCity on adolescents' opioid safety knowledge, awareness, behavioral intent, and self-efficacy.
METHODS


A nationally representative sample of adolescents age 12 to 18 years old were recruited online through Qualtrics panels from October to November 2020. Data collection consisted of a pre-game survey, 30 minutes of gameplay, and a post-game survey. The pre- and post-game survey included 66 items examining participants' baseline opioid knowledge, safety, and use, and demographic information. The post-game survey had 25 additional questions regarding the MedSMA℞T game. Gameplay scenarios included five levels intended to mimic adolescents' daily life while educating players about appropriate opioid storage and disposable practices, negative consequences of sharing opioid medications, and use of Narcan®. Survey questions were divided into 10 categories to represent key concepts and summarized into concept scores. Differences in concept scores were described by overall mean (SD) when stratified by gender, race, school, grade, and age. Differences of change in concept score were analyzed using Kruskal-Wallis and correlation tests.
RESULTS


A total of 117 responses were analyzed. Results showed significant improvement on all concept scores except for Narcan® knowledge (mean change = -0.04, SD = 0.29, p = 0.600) and safe storage (mean change = 0.03, SD = 0.20, p = 0.088). Female participants had greater improvement than males for safe disposal (female mean (SD) = 0.12 (0.25), male = 0.04 (0.17), p = 0.050). Male participants had higher improvement than females for misuse behavior (female mean (SD) = 0.05 (0.28) male = 0.14 (0.27), p = 0.043). Perceived knowledge for participants who were non-white or Hispanic had higher improvement than non-Hispanic white participants (non-white mean (SD) = 1.10 (1.06), white = 0.75 (0.91), p = 0.026). Older grades were associated with greater improvement in opioid knowledge (correlation coefficient -0.23 (95% CI -0.40 to -0.05), p = 0.012). There were 28 (23.9%) participants who played all 5 levels of the game and had better improvement in opioid use self-efficacy.
CONCLUSIONS


Findings suggest MedSMA℞T: Adventures in PharmaCity can be used as an effective tool to educate adolescents on the safe and responsible use of prescribed opioid medications. Future testing of the effectiveness of this SG should involve a randomized control trial. Additionally, the feasibility of implementing and disseminating MedSMA℞T: Adventures in PharmaCity in schools and healthcare settings, such as adolescent health or primary care clinics, emergency departments, and pharmacies, should be investigated.
CLINICALTRIAL


",2021,"Results showed significant improvement on all concept scores except for Narcan® knowledge (mean change = -0.04, SD = 0.29, p = 0.600) and safe storage (mean change = 0.03, SD = 0.20, p = 0.088).","['Male participants', 'A nationally representative sample of adolescents age 12 to 18 years old were recruited online through Qualtrics panels from October to November 2020', 'Adolescents', 'participants who were non-white or Hispanic had higher improvement than non-Hispanic white participants (non-white mean (SD) ']",[],"['opioid knowledge', ""adolescents' daily life while educating players about appropriate opioid storage and disposable practices, negative consequences of sharing opioid medications, and use of Narcan®"", 'opioid use self-efficacy', 'misuse behavior', 'Narcan® knowledge', 'baseline opioid knowledge, safety, and use, and demographic information', 'safe storage', 'safe disposal', 'Opioid Safety Awareness']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",[],"[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0684237', 'cui_str': 'Narcanti'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",117.0,0.123709,"Results showed significant improvement on all concept scores except for Narcan® knowledge (mean change = -0.04, SD = 0.29, p = 0.600) and safe storage (mean change = 0.03, SD = 0.20, p = 0.088).","[{'ForeName': 'Olufunmilola', 'Initials': 'O', 'LastName': 'Abraham', 'Affiliation': 'Social and Administrative Sciences Division, School of Pharmacy, University of Wisconsin-Madison, 777 Highland Ave, Madison, US.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Rosenberger', 'Affiliation': 'Social and Administrative Sciences Division, School of Pharmacy, University of Wisconsin-Madison, 777 Highland Ave, Madison, US.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Tierney', 'Affiliation': 'Social and Administrative Sciences Division, School of Pharmacy, University of Wisconsin-Madison, 777 Highland Ave, Madison, US.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Birstler', 'Affiliation': 'Biostatistics and Medical Informatics, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, US.'}]",JMIR serious games,['10.2196/33975']
2253,34747704,An App-Based Intervention for Adolescents Exposed to Cyberbullying in Norway: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Adolescents exposed to negative online events are at high risk to develop mental health problems. Little is known about what is effective for treatment in this group. NettOpp is a new mobile app for adolescents who have been exposed to cyberbullying or negative online experiences in Norway.
OBJECTIVE


The aim of this paper is to provide a description of the content of the intervention and about a randomized controlled trial that will be conducted to examine the effectiveness of NettOpp. This protocol is written in accordance with the Spirit 2013 Checklist.
METHODS


An effectiveness study with a follow-up examination after 3 months will be conducted to evaluate the mobile app. Adolescents will be recruited through schools and will be randomly assigned to the intervention (NettOpp) group and a waiting-list control group. The adolescents (aged 11 to 16 years) will respond to self-report questionnaires on the internet. Primary outcomes will be changes in mental health assessed with the Strengths and Difficulties Questionnaire, the WHO-Five Well-being Index, and the Child and Adolescent Trauma Screen.
RESULTS


Recruitment will start in January 2022. The results from this study will be available in 2023.
CONCLUSIONS


There are few published evaluation studies on app-based interventions. This project and its publications will contribute new knowledge to the field.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04176666; https://clinicaltrials.gov/ct2/show/NCT04176666.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/31789.",2021,"NettOpp is a new mobile app for adolescents who have been exposed to cyberbullying or negative online experiences in Norway.
","['Adolescents Exposed to Cyberbullying in Norway', 'adolescents (aged 11 to 16 years', 'adolescents who have been exposed to cyberbullying or negative online experiences in Norway']",['intervention (NettOpp) group and a waiting-list control group'],"['changes in mental health assessed with the Strengths and Difficulties Questionnaire, the WHO-Five Well-being Index, and the Child and Adolescent Trauma Screen']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",,0.354664,"NettOpp is a new mobile app for adolescents who have been exposed to cyberbullying or negative online experiences in Norway.
","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Kaiser', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare - North, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Martinussen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare - North, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Adolfsen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare - North, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Kyrre', 'Initials': 'K', 'LastName': 'Breivik', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare - West, NORCE, Norwegian Research Center AS, Bergen, Norway.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Kyrrestad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare - North, UiT The Arctic University of Norway, Tromsø, Norway.'}]",JMIR research protocols,['10.2196/31789']
2254,34747701,Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial.,"BACKGROUND


Poor self-management of heart failure (HF) contributes to devastating health consequences. Our innovative sensor-controlled digital game (SCDG) integrates data from sensors to trigger game rewards, progress, and feedback based on the real-time behaviors of individuals with HF.
OBJECTIVE


The aim of this study is to compare daily weight monitoring and physical activity behavior adherence by older adults using an SCDG intervention versus a sensors-only intervention in a feasibility randomized controlled trial.
METHODS


English-speaking adults with HF aged 55 years or older who owned a smartphone and could walk unassisted were recruited from Texas and Oklahoma from November 2019 to August 2020. Both groups were given activity trackers and smart weighing scales to track behaviors for 12 weeks. The feasibility outcomes of recruitment, retention, intervention engagement, and satisfaction were assessed. In addition to daily weight monitoring and physical activity adherence, the participants' knowledge, functional status, quality of life, self-reported HF behaviors, motivation to engage in behaviors, and HF-related hospitalization were also compared between the groups at baseline and at 6, 12, and 24 weeks.
RESULTS


A total of 38 participants with HF-intervention group (IG; 19/38, 50%) and control group (CG; 19/38, 50%)-were enrolled in the study. Of the 38 participants, 18 (47%) were women, 18 (47%) were aged 65 years or older, 21 (55%) had been hospitalized with HF in the past 6 months, and 29 (76%) were White. Furthermore, of these 38 participants, 31 (82%)-IG (15/19, 79%) and CG (16/19, 84%)-had both weight monitoring and physical activity data at the end of 12 weeks, and 27 (71%)-IG (14/19, 74%) and CG (13/19, 68%)-participated in follow-up assessments at 24 weeks. For the IG participants who installed the SCDG app (15/19, 79%), the number of days each player opened the game app was strongly associated with the number of days the player engaged in weight monitoring (r=0.72; P=.04) and the number of days with physical activity step data (r=0.9; P<.001). The IG participants who completed the satisfaction survey (13/19, 68%) reported that the SCDG was easy to use. Trends of improvement in daily weight monitoring and physical activity in the IG, as well as within-group improvements in HF functional status, quality of life, knowledge, self-efficacy, and HF hospitalization in both groups, were observed in this feasibility trial.
CONCLUSIONS


Playing an SCDG on smartphones was feasible and acceptable for older adults with HF for motivating daily weight monitoring and physical activity. A larger efficacy trial of the SCDG intervention will be needed to validate trends of improvement in daily weight monitoring and physical activity behaviors.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03947983; https://clinicaltrials.gov/ct2/show/NCT03947983.",2021,"A total of 38 participants with HF-intervention group (IG; 19/38, 50%) and control group (CG; 19/38, 50%)-were enrolled in the study.","['38 participants with HF-intervention group (IG; 19/38, 50%) and control group (CG; 19/38, 50%)-were enrolled in the study', 'older adults', '38 participants, 31 (82%)-IG (15/19, 79%) and CG (16/19, 84%)-had both weight monitoring and physical activity data at the end of 12 weeks, and 27 (71%)-IG', 'English-speaking adults with HF aged 55 years or older who owned a smartphone and could walk unassisted were recruited from Texas and Oklahoma from November 2019 to August 2020', '38 participants, 18 (47%) were women, 18 (47%) were aged 65 years or older, 21 (55%) had been hospitalized with HF in the past 6 months, and 29 (76%) were White']","['Sensor-Controlled Digital Game', 'SCDG intervention versus a sensors-only intervention', 'SCDG intervention']","['daily weight monitoring and physical activity behavior adherence', 'number of days with physical activity step data', ""participants' knowledge, functional status, quality of life, self-reported HF behaviors, motivation to engage in behaviors, and HF-related hospitalization"", 'daily weight monitoring and physical activity', 'recruitment, retention, intervention engagement, and satisfaction', 'HF functional status, quality of life, knowledge, self-efficacy, and HF hospitalization', 'number of days the player engaged in weight monitoring']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0513836', 'cui_str': 'Weight monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0028914', 'cui_str': 'Oklahoma'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0513836', 'cui_str': 'Weight monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",38.0,0.166815,"A total of 38 participants with HF-intervention group (IG; 19/38, 50%) and control group (CG; 19/38, 50%)-were enrolled in the study.","[{'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Radhakrishnan', 'Affiliation': 'School of Nursing, The University of Texas Austin, Austin, TX, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Julien', 'Affiliation': 'Department of Electrical and Computer Engineering, Cockrell School of Engineering, The University of Texas Austin, Austin, TX, United States.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Baranowski', 'Affiliation': 'Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': ""O'Hair"", 'Affiliation': 'Good Life Games, Inc, Austin, TX, United States.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Electrical and Computer Engineering, Cockrell School of Engineering, The University of Texas Austin, Austin, TX, United States.'}, {'ForeName': 'Atami', 'Initials': 'A', 'LastName': 'Sagna De Main', 'Affiliation': 'School of Nursing, The University of Texas Austin, Austin, TX, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'School of Nursing, The University of Texas Austin, Austin, TX, United States.'}, {'ForeName': 'Bindu', 'Initials': 'B', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Statistics and Data Sciences, The University of Texas Austin, Austin, TX, United States.'}, {'ForeName': 'Edison', 'Initials': 'E', 'LastName': 'Thomaz', 'Affiliation': 'Department of Electrical and Computer Engineering, Cockrell School of Engineering, The University of Texas Austin, Austin, TX, United States.'}, {'ForeName': 'Miyong', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'School of Nursing, The University of Texas Austin, Austin, TX, United States.'}]",JMIR serious games,['10.2196/29044']
2255,34747667,"Effects of smartphone use before resistance exercise on inhibitory control, heart rate variability, and countermovement jump.","BACKGROUND


The effect of MF induced by exposure time to social media smartphone apps on inhibitory control, heart rate variability (HRV), and high-intensity physical effort following a resistance exercise session might indicate whether strength and conditioning professionals should suggest avoiding smartphone usage before a resistance exercise session.
AIM


The objective of this study was to analyze the effect of mental fatigue on inhibitory control, HRV, and countermovement jump (CMJ) in trained adults after resistance exercise.
METHODS


A total of 16 trained males (21.4 ± 3.3 years) volunteered in this study. The participants performed resistance exercises with and without mental fatigue. The Stroop Task, countermovement jump, and heart rate variability were evaluated before and after the resistance exercise. The participants used smartphones in the mental fatigue condition, whereas the participants watched TV in the control condition.
RESULTS


No condition × time interaction was found for the Stroop accuracy ( p  = 0.87), CMJ ( p  = 0.68), SDNN ( p  = 0.15), or pNN50 ( p  = 0.15) in the heart rate variability. An interaction was found for Stroop response time ( p  = 0.01) with a higher response time for the mental fatigue condition ( p  = 0.01).
CONCLUSIONS


Mental fatigue impaired the inhibitory control performance after a resistance exercise session in trained adults.",2021,"An interaction was found for Stroop response time ( p  = 0.01) with a higher response time for the mental fatigue condition ( p  = 0.01).
","['trained adults after resistance exercise', 'trained adults', '16 trained males (21.4\u2009±\u20093.3\u2009years) volunteered in this study']","['resistance exercises with and without mental fatigue', 'smartphone', 'MF']","['Stroop Task, countermovement jump, and heart rate variability', 'inhibitory control, heart rate variability (HRV', 'inhibitory control, heart rate variability, and countermovement jump', 'Stroop accuracy', 'inhibitory control, HRV, and countermovement jump (CMJ', 'Stroop response time']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",16.0,0.0196416,"An interaction was found for Stroop response time ( p  = 0.01) with a higher response time for the mental fatigue condition ( p  = 0.01).
","[{'ForeName': 'Dalton de', 'Initials': 'D', 'LastName': 'Lima-Junior', 'Affiliation': 'Department of Physical Education, Universidade Federal da Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Leonardo S', 'Initials': 'LS', 'LastName': 'Fortes', 'Affiliation': 'Department of Physical Education, Universidade Federal da Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Maria E C', 'Initials': 'MEC', 'LastName': 'Ferreira', 'Affiliation': 'Department of Physical Education, Universidade Federal de Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Petrus', 'Initials': 'P', 'LastName': 'Gantois', 'Affiliation': 'Department of Physical Education, Universidade Federal da Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Bruno Teixeira', 'Initials': 'BT', 'LastName': 'Barbosa', 'Affiliation': 'Department of Physical Education, Universidade Federal da Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Maicon R', 'Initials': 'MR', 'LastName': 'Albuquerque', 'Affiliation': 'Sports, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Fabiano S', 'Initials': 'FS', 'LastName': 'Fonseca', 'Affiliation': 'Department of Physical Education, Universidade Federal Rural de Pernambuco, Recife, Brazil.'}]",Applied neuropsychology. Adult,['10.1080/23279095.2021.1990927']
2256,34748122,Health-Related Quality of Life After Nipple-Sparing Mastectomy: Results From the INSPIRE Registry.,"INTRODUCTION


Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is increasingly used for both breast cancer (TNSM) and risk reduction (RRNSM). The aim of the study is to report the results of the INSPIRE registry assessing health-related quality of life (HRQoL) comparing baseline and 1-year follow-up, regarding surgical indications and chemotherapy (CT) received.
METHODS


INSPIRE is a prospective database including women undergoing NSM and IBR from 18 countries. HRQoL was measured using EORTC QLQC30 and QLQ-BR23 before surgery and after 1 year.
RESULTS


A total of 677 women were included, of whom 537 (79.3%) underwent TNSM and 140 (21.6%) RRNSM: in total, 806 NSM (556 TNSM and 250 RRNSM). Nipple involvement was present in 7.73% of TNSM and incidental carcinoma in 1.2% of the RRNSM group. Out of the overall 537 patients with systemic treatment, 177 (32.96%) received neoadjuvant chemotherapy (NCT) and 118 (21.92%) adjuvant chemotherapy (CT). A total of 227 patients (28.16%) developed at least one complication postoperatively, 164 (29.5%) in the TNSM group and 63 (25.2%) in the RRNSM group. The TNSM group improved in global health status and emotional functioning after 1 year. No differences were found when comparing HRQoL at 1 year between patients who received NCT and those who received adjuvant CT. The RRNSM group showed improvement in HRQoL, with better emotional functioning and fatigue after 1 year.
CONCLUSIONS


This registry reports HRQoL findings after NSM. The impact of CT on worse HRQoL is independent from its timing. Patients with RRNSM showed an improved HRQoL at 1-year follow-up. Discussion of HRQoL outcomes with patients will facilitate the informed decision-making when considering NSM.",2021,The TNSM group improved in global health status and emotional functioning after 1 year.,"['537 patients with systemic treatment, 177 (32.96%) received', 'women undergoing NSM and IBR from 18 countries', 'A total of 677 women were included, of whom 537 (79.3%) underwent TNSM and 140 (21.6%) RRNSM: in total, 806 NSM (556 TNSM and 250 RRNSM']","['NCT', 'adjuvant chemotherapy (CT', 'TNSM', 'CT', 'chemotherapy (CT', 'adjuvant CT', 'neoadjuvant chemotherapy (NCT', 'Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR', 'Nipple-Sparing Mastectomy']","['HRQoL', 'HRQoL, with better emotional functioning and fatigue', 'Health-Related Quality of Life', 'global health status and emotional functioning', 'Nipple involvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]",677.0,0.13257,The TNSM group improved in global health status and emotional functioning after 1 year.,"[{'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Esgueva', 'Affiliation': 'Breast Surgical Oncology Unit, Clinica Universidad de Navarra, Cancer Center Universidad de Navarra, Madrid, Spain.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Noordhoek', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Elma Meershoek-Klein', 'Initials': 'EM', 'LastName': 'Kranenbarg', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Espinosa-Bravo', 'Affiliation': ""Breast Surgical Unit, Hospital Universitario Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Mátrai', 'Affiliation': 'Department of Breast and Sarcoma Surgery, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Andrii', 'Initials': 'A', 'LastName': 'Zhygulin', 'Affiliation': 'Breast Unit, LISOD, Hospital of Israeli Oncology, Kiev, Ukraine.'}, {'ForeName': 'Arvids', 'Initials': 'A', 'LastName': 'Irmejs', 'Affiliation': 'Breast Unit, Pauls Stradins Clinical University Hospital, Institute of Oncology, Riga Stradins University, Riga, Latvia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Mavioso', 'Affiliation': 'Breast Unit Centro Clínico Champalimaud, Lisboa, Portugal.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Meani', 'Affiliation': 'Centro di Senologia della Svizzera Italiana, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'González', 'Affiliation': 'Instituto de Oncología Ángel H. Roffo, Buenos Aires, Argentina.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Özdemir', 'Affiliation': 'Ege Üniversitesi, Izmir, Turkey.'}, {'ForeName': 'Tanir', 'Initials': 'T', 'LastName': 'Allweis', 'Affiliation': 'Kaplan Medical Center, Rehovot, Israel.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Rogowski', 'Affiliation': 'Bialostockie Centrum Onkologii, Bialystok, Poland.'}, {'ForeName': 'Catarina Rodrigues', 'Initials': 'CR', 'LastName': 'Dos Santos', 'Affiliation': 'IPO Francisco Gentil, Lisboa, Portugal.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Mora', 'Affiliation': 'Centro Hospitalar Universitário Sao Joao, Porto, Portugal.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Ponzone', 'Affiliation': 'Candiolo Cancer Institute, FPO - IRCCS, Turin, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Samorani', 'Affiliation': 'AUSL Romagna, Rimini, Italy.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'van de Velde', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Riccardo A', 'Initials': 'RA', 'LastName': 'Audisio', 'Affiliation': 'Sahlgrenska Universitetssjukhuset, Gotenburg, Sweden.'}, {'ForeName': 'Isabel T', 'Initials': 'IT', 'LastName': 'Rubio', 'Affiliation': 'Breast Surgical Oncology Unit, Clinica Universidad de Navarra, Cancer Center Universidad de Navarra, Madrid, Spain. irubior@unav.es.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgical oncology,['10.1245/s10434-021-10930-1']
2257,34748096,The effects of resistance training in patients with primary Sjogren's syndrome.,"INTRODUCTION


Resistance training (RT) is well tolerated and has shown promise for decreasing fatigue. However, the effects of RT have never been examined in primary Sjogren's syndrome (pSS).
OBJECTIVE


To assess the feasibility, effectiveness, and safety of a resistance exercise program on fatigue in patients with pSS.
METHODS


This is a parallel, single-blind randomized trial. Women aged 18 years or older, diagnosed with pSS according to the American-European criteria, were included. We randomized 59 participants to a resistance training group (RT) or a control group (CG). Participants in the RT group performed a 16-week resistance exercise program. The sessions consisted of three sets of resistance exercises (10 repetitions each) at 60 to 80% of 1 repetition maximum, designed to improve whole-body strength. The participants in the CG received their usual pharmacological treatment and instructions regarding disease control, pain management, sleep hygiene, and activities of daily living. To compare intergroup and intragroup variability, a one-factor repeated-measures analysis of variance (ANOVA) was used.
RESULTS


RT effectively improved fatigue, pain, functional capacity, emotional aspects, vitality, and subjective perception of disease activity by the patient. No between-group differences were found in the ESSPRI mental score, ESSDAI, SF-36-Physical Aspects, SF-36-General Health, SF-36-Social aspects, and SF-36-Mental Health after the training period.
CONCLUSION


An RT program was safe and effective in improving fatigue, pain, functional capacity, emotional aspects, vitality, and subjective perception of disease activity by the patient in women with pSS. Key Points • This is the first study to evaluate the effects of a resistance training program on fatigue in patients with primary Sjogren's syndrome. • A resistance training program was shown to be effective in improving fatigue in patients with primary Sjogren's syndrome. • A resistance training program is well-tolerated, has good compliance, and is not associated with serious adverse effects in patients with primary Sjogren's syndrome.",2021,"RESULTS


RT effectively improved fatigue, pain, functional capacity, emotional aspects, vitality, and subjective perception of disease activity by the patient.","['Women aged 18 years or older, diagnosed with pSS according to the American-European criteria, were included', 'patients with pSS', ""patients with primary Sjogren's syndrome"", ""primary Sjogren's syndrome (pSS""]","['resistance training', 'resistance exercise program', 'resistance training program', 'usual pharmacological treatment and instructions regarding disease control, pain management, sleep hygiene, and activities of daily living', 'resistance training group (RT) or a control group (CG', 'resistance exercises', 'RT', 'Resistance training (RT']","['ESSPRI mental score, ESSDAI, SF-36-Physical Aspects, SF-36-General Health, SF-36-Social aspects, and SF-36-Mental Health', 'safe and effective in improving fatigue, pain, functional capacity, emotional aspects, vitality, and subjective perception of disease activity', 'feasibility, effectiveness, and safety', 'fatigue, pain, functional capacity, emotional aspects, vitality, and subjective perception of disease activity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0243152', 'cui_str': 'emotional aspects'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",59.0,0.0194822,"RESULTS


RT effectively improved fatigue, pain, functional capacity, emotional aspects, vitality, and subjective perception of disease activity by the patient.","[{'ForeName': 'Luciana Paula', 'Initials': 'LP', 'LastName': 'Dardin', 'Affiliation': 'Evidence-Based Health Program, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP), R. Botucatu, 740 - 3o andar, Vila Clementino, São Paulo, SP, CEP 04023-900, Brazil.'}, {'ForeName': 'Ana Beatriz Andreo', 'Initials': 'ABA', 'LastName': 'Garcia', 'Affiliation': 'Evidence-Based Health Program, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP), R. Botucatu, 740 - 3o andar, Vila Clementino, São Paulo, SP, CEP 04023-900, Brazil.'}, {'ForeName': 'Paulo Alexandre', 'Initials': 'PA', 'LastName': 'Minali', 'Affiliation': 'Evidence-Based Health Program, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP), R. Botucatu, 740 - 3o andar, Vila Clementino, São Paulo, SP, CEP 04023-900, Brazil.'}, {'ForeName': 'Ana Carolina Pereira Nunes', 'Initials': 'ACPN', 'LastName': 'Pinto', 'Affiliation': 'Evidence-Based Health Program, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP), R. Botucatu, 740 - 3o andar, Vila Clementino, São Paulo, SP, CEP 04023-900, Brazil. anacarolinapnp@hotmail.com.'}, {'ForeName': 'Virginia Fertnandes Moça', 'Initials': 'VFM', 'LastName': 'Trevisani', 'Affiliation': 'Evidence-Based Health Program, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP), R. Botucatu, 740 - 3o andar, Vila Clementino, São Paulo, SP, CEP 04023-900, Brazil.'}]",Clinical rheumatology,['10.1007/s10067-021-05977-0']
2258,34748085,The impact of education through nurse-led telephone follow-up (telenursing) on the quality of life of COVID-19 patients.,"BACKGROUND


The widespread prevalence of COVID-19 has disrupted the social life, physical function, and daily activities of patients, leading to reduced quality of their lives. Because of the nature of this disease and its comprehensive impact on patients' lives, a follow-up based on the conditions of these patients is necessary. This study was conducted to determine the impact of nurse education and telephone follow-up (telenursing) on the quality of life of COVID-19 patients.
METHODS


This quasi-experimental study included 120 COVID-19 patients discharged from 22nd-Bahman Hospital in Khaf city and was conducted over 6 months from July 20, 2020, to December 20, 2020. The participants were selected by convenience sampling method and were assigned into two matching groups. The training was delivered through telenursing based on the quality of life criteria for 1 month in the intervention group. The controls did not receive any intervention. Both groups completed the 36-item SF health survey before and 1 month after the intervention.
RESULTS


The two groups were not significantly different regarding the quality of life mean scores at baseline (p = 0.61). However, after the intervention, the mean and standard deviation of the total life quality score was significantly different between the control and intervention groups (63.62 ± 3.93 versus 72.62 ± 3.51, p <0.001).
CONCLUSIONS


Telenursing improves the life quality of COVID-19 patients. Through appropriate policies, health managers may put on the agenda the implementation of telenursing for COVID-19 patients.",2021,The two groups were not significantly different regarding the quality of life mean scores at baseline (p = 0.61).,"['120 COVID-19 patients discharged from 22nd-Bahman Hospital in Khaf city and was conducted over 6 months from July 20, 2020, to December 20, 2020', 'COVID-19 patients']",['nurse education and telephone follow-up (telenursing'],"['life quality', 'mean and standard deviation of the total life quality score', '36-item SF health survey', 'quality of life mean scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",120.0,0.0448437,The two groups were not significantly different regarding the quality of life mean scores at baseline (p = 0.61).,"[{'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Raesi', 'Affiliation': 'Bahman Khaf Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra Abbasi', 'Initials': 'ZA', 'LastName': 'Shaye', 'Affiliation': 'Community Medicine, Akbar Clinical Research & Development Unit, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Saghari', 'Affiliation': 'Department of Health Services Management, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Sheikh Beig Goharrizi', 'Affiliation': 'Atherosclerosis Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Raei', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kiavash', 'Initials': 'K', 'LastName': 'Hushmandi', 'Affiliation': 'Department of Food Hygiene and Quality Control, Division of Epidemiology & Zoonoses, Faculty of Veterinary Medicine, University of Tehran, Tehran, Iran. kiavashhoushmandi@gmail.com.'}]",The Journal of the Egyptian Public Health Association,['10.1186/s42506-021-00093-y']
2259,34747977,Noninferiority and Safety of Nadolol vs Propranolol in Infants With Infantile Hemangioma: A Randomized Clinical Trial.,"Importance


Propranolol for infantile hemangiomas (IH) has been shown to be effective and relatively safe. However, other less lipophilic β-blockers, such as nadolol, may be preferable in individuals who experience propranolol unresponsiveness or adverse events.
Objective


To document the noninferiority and safety of oral nadolol compared with oral propranolol in infants with IH.
Design, Setting, and Participants


This double-blind noninferiority prospective study with a noninferiority margin of 10% compared propranolol with nadolol in infants aged 1 to 6 months with problematic IH. The study was conducted in 2 academic pediatric dermatology centers in Canada between 2016 and 2020. Infants aged 1 to 6 months with a hemangioma greater than 1.5 cm on the face or 3 cm or greater on another body part causing or with potential to cause functional impairment or cosmetic disfigurement.
Interventions


Oral propranolol and nadolol in escalating doses up to 2 mg/kg/d.
Main Outcomes and Measure


Between-group differences comparing changes in the bulk (size and extent) and color of the IH at week 24 with baseline using a 100-mm visual analog scale.
Results


The study included 71 patients. Of these, 36 were treated with propranolol. The mean (SD) age in this group was 3.1 (1.4) months, and 31 individuals (86%) were female. Thirty-five infants were treated with nadolol. The mean (SD) age in this group was 3.2 (1.6) months, and 26 individuals (74%) were female. The difference in IH between groups by t test was 8.8 (95% CI, 2.7-14.9) for size and 17.1 (95% CI, 7.2-30.0) for color in favor of the nadolol group, demonstrating that nadolol was noninferior to propranolol. Similar differences were noted at 52 weeks: 6.0 (95% CI, 1.9-10.1) and 10.1 (95% CI, 2.9-17.4) for size and color improvement, respectively. For each doubling of time unit (week), the coefficient of involution was 2.4 (95% CI, 0.5-4.4) higher with nadolol compared with propranolol. Safety data were similar between the 2 interventions.
Conclusions and Relevance


Oral nadolol was noninferior to oral propranolol, indicating it may be an efficacious and safe alternative in cases of propranolol unresponsiveness or adverse events, or when faster involution is required.
Trial Registration


ClinicalTrials.gov Identifier: NCT02505971.",2021,"Safety data were similar between the 2 interventions.
","['2 academic pediatric dermatology centers in Canada between 2016 and 2020', 'Infants aged 1 to 6 months with a hemangioma greater than 1.5 cm on the face or 3 cm or greater on another body part causing or with potential to cause functional impairment or cosmetic disfigurement', 'individuals who experience propranolol unresponsiveness or adverse events', 'infants aged 1 to 6 months with problematic IH', 'infants with IH.\nDesign, Setting, and Participants', 'Infants With Infantile Hemangioma', '71 patients']","['oral propranolol', 'propranolol', 'Nadolol vs Propranolol', 'nadolol', 'propranolol with nadolol', 'oral nadolol', 'propranolol and nadolol', 'Propranolol']","['coefficient of involution', 'bulk (size and extent) and color of the IH', '100-mm visual analog scale']","[{'cui': 'C3263715', 'cui_str': 'Pediatric dermatology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018916', 'cui_str': 'Hemangioma'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0229962', 'cui_str': 'Body part structure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1707791', 'cui_str': 'Disfigurement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0206733', 'cui_str': 'Strawberry nevus of skin'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0027302', 'cui_str': 'Nadolol'}]","[{'cui': 'C0333953', 'cui_str': 'Involution'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0206733', 'cui_str': 'Strawberry nevus of skin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",71.0,0.309029,"Safety data were similar between the 2 interventions.
","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pope', 'Affiliation': 'Division of Pediatric Dermatology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Lara-Corrales', 'Affiliation': 'Division of Pediatric Dermatology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Sibbald', 'Affiliation': 'Division of Pediatric Dermatology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Liy-Wong', 'Affiliation': ""Division of Dermatology and Rheumatology, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.""}, {'ForeName': 'Nordau', 'Initials': 'N', 'LastName': 'Kanigsberg', 'Affiliation': ""Division of Dermatology and Rheumatology, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.""}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Drolet', 'Affiliation': 'Department of Dermatology, University of Wisconsin-Madison.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Biostatistics Research Unit, University Health Network, Toronto, Ontario, Canada.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2021.4565']
2260,34735963,Does a psychiatric history play a role in the development of psychiatric adverse events to perampanel… and to placebo?,"OBJECTIVE


The purpose of this study was to establish whether a past psychiatric history could play a role in the development of psychiatric treatment-emergent adverse events (PTEAEs) in patients randomized to perampanel (PER) or placebo.
METHODS


The development of PTEAEs was compared between patients with/without a psychiatric history in a post hoc analysis from four randomized placebo-controlled trials (RPCTs) of PER (304/305/306/335) in patients with treatment-resistant focal epilepsy.
RESULTS


Among the 2,187 patients enrolled in the RPCTs, 352 (16.1%) had a psychiatric history (PER n = 244; placebo n = 108), while 1835 patients (83.9%) did not (PER n = 1325; placebo n = 510). Compared to patients without a psychiatric history, those with a positive history reported more PTEAEs for both patients randomized to PER (11.8% vs. 29.9%, p < 0.01) or to placebo (9.2% vs. 19.4%, p < 0.01). The prevalence of PTEAEs was not higher among patients randomized to 2 mg and 4 mg/day doses than placebo in both those with and without psychiatric history. Rather, the higher prevalence rates were among subjects randomized to 8 mg (29.8%) and 12 mg (36.4%) PER doses in patients with a past psychiatric history.
SIGNIFICANCE


A psychiatric history appears to increase the risk of PTEAEs in patients randomized to placebo and to PER at doses of 8 and 12 mg/day. It should be identified in all patients considered for treatment with PER, particularly when prescribed at doses above 4 mg/day.",2021,The prevalence of PTEAEs was not higher among patients randomized to 2 mg and 4 mg/day doses than placebo in both those with and without psychiatric history.,"['2,187 patients enrolled in the RPCTs, 352 (16.1%) had a psychiatric history (PER n\u202f=\u202f244', 'patients randomized to', 'patients with treatment-resistant focal epilepsy']","['placebo', 'perampanel (PER) or placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}]",[],2187.0,0.137045,The prevalence of PTEAEs was not higher among patients randomized to 2 mg and 4 mg/day doses than placebo in both those with and without psychiatric history.,"[{'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Kanner', 'Affiliation': 'University of Miami, Miller School of Medicine, Miami, FL, USA. Electronic address: a.kanner@med.miami.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd., Hatfield, Hertfordshire, UK.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Ettinger', 'Affiliation': 'United Diagnostics and United Medical Monitoring, Garden City, NY, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Helmstaedter', 'Affiliation': 'University of Bonn, Bonn, Germany.'}, {'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.108380']
2261,34735908,"An 8-week randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of red Platycodon grandiflorus root extract on enhancement of immune function.","BACKGROUND


The immune-enhancing effects of red Platycodon grandiflorus root extract (RPGE) has been reported in vitro and in vivo, but there are few studies on humans. Therefore, this study aimed to investigate the efficacy and safety of RPGE in enhancing immune function in healthy subjects.
SUBJECTS AND METHODS


An 8-week randomized, double-blind, parallel, placebo-controlled clinical trial was conducted at the Gachon University Gil Medical Center, Incheon, South Korea. A total of 100 adults aged 20-75 years with white blood cell counts of 3000-10,000 cell/µL were randomly divided into two groups (RPGE group, 50 and placebo group, 50) using a computer-generated random list with a 1:1 allocation ratio. The subjects consumed RPGE (2 times/day, 2 tablets/time, 375 mg RPGE powder/tablet) or placebo for 8 weeks. All test foods for the human study were coded and administered under double-blind conditions. The primary outcome was a change in the NK cell activity after 8 weeks of treatment compared to the baseline.
RESULTS


Among 100 subjects enrolled for the study, 87 completed the study. NK cell activity (p = 0.005) and IFN-γ level (p = 0.003) of the RPGE group (n = 41) were higher than those of the placebo group (n = 46). The findings of the safety assessment revealed absence of clinically significant changes in any test and serious adverse events throughout the study.
CONCLUSION


In conclusion, these results demonstrate the efficacy and safety of RPGE, suggesting it to be a beneficial agent for enhancing immune function in humans.
TRIAL REGISTRATION


CRIS Registration Number KCT0005945, https://cris.nih.go.kr.",2021,NK cell activity (p = 0.005) and IFN-γ level (p = 0.003) of the RPGE group (n = 41) were higher than those of the placebo group (n = 46).,"['100 subjects enrolled for the study, 87 completed the study', '100 adults aged 20-75 years with white blood cell counts of 3000-10,000\xa0cell/µL', 'healthy subjects', 'Gachon University Gil Medical Center, Incheon, South Korea']","['placebo group, 50) using a computer-generated random list with a 1:1 allocation ratio', 'red Platycodon grandiflorus root extract (RPGE', 'red Platycodon grandiflorus root extract', 'placebo', 'RPGE']","['NK cell activity', 'enhancement of immune function', 'IFN-γ level', 'efficacy and safety', 'change in the NK cell activity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0574385', 'cui_str': 'Gilbertese language'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C3485016', 'cui_str': 'Platycodon grandiflorum root extract'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",100.0,0.74037,NK cell activity (p = 0.005) and IFN-γ level (p = 0.003) of the RPGE group (n = 41) were higher than those of the placebo group (n = 46).,"[{'ForeName': 'Eun-Jung', 'Initials': 'EJ', 'LastName': 'Park', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Gyeonggi-do 13120, Republic of Korea; Institute for Aging and Clinical Nutrition Research, Gachon University, Gyeonggi-do 13120, Republic of Korea.'}, {'ForeName': 'Ah Jin', 'Initials': 'AJ', 'LastName': 'Jung', 'Affiliation': 'Institute for Aging and Clinical Nutrition Research, Gachon University, Gyeonggi-do 13120, Republic of Korea.'}, {'ForeName': 'Sung-Hyen', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Rural Department Administration, National Institute of Agricultural Sciences, Wanju, Jeonbuk 55365, Republic of Korea.'}, {'ForeName': 'Seong-Kyu', 'Initials': 'SK', 'LastName': 'Kang', 'Affiliation': 'Department of Occupational and Environmental Medicine, Gachon University College of Medicine, Incheon 21565, Republic of Korea. Electronic address: sk.kang@gachon.ac.kr.'}, {'ForeName': 'Hae-Jeung', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Gyeonggi-do 13120, Republic of Korea; Institute for Aging and Clinical Nutrition Research, Gachon University, Gyeonggi-do 13120, Republic of Korea. Electronic address: skysea@gachon.ac.kr.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2021.153811']
2262,34735887,Effect of educational intervention addressing inaccurate self-assessment of driving performance in older Japanese adults.,"To maintain road safety for older drivers as well as other road users, it is important to provide interventions that improve self-awareness and behaviors in older drivers. We developed an intervention that provides feedback on accuracy of self-awareness of driving performance using a workbook, and examined its effectiveness using a prospective design with a follow-up after two months. Japanese drivers aged between 69 and 87 (Mean = 73.96) years were assigned to either the intervention group (n = 26) or the wait-list control group (n = 27). All participants were asked to assess their own driving performance by completing a questionnaire. They also completed an on-road driving assessment that involved driving on a public road while wearing an electronic device that measured their actual driving behaviors, accompanied by a driving instructor who sat in the passenger seat and assessed the participant's driving performance (expert assessment). Thereafter, only the intervention group received the immediate intervention (first wave). One month later, the intervention group completed the booster intervention by post. Two months after the first wave, both groups completed the questionnaire and on-road driving assessment again (second wave). Result revealed that discrepancy between self-assessment and expert assessment reduced in only the intervention group between the two waves. This finding suggests that the intervention was able to improve the accuracy of self-assessment. Furthermore, the expert assessment improved in the intervention group between the two waves, but this change was not observed in the control group. Similar trend was evident for vehicle speed at intersections with a stop sign but the result was not statistically significant. Changes in head rotation at intersections requiring turn in the intervention group did not differ from those in the control group. Improved accuracy of self-assessment as a result of the intervention could have led to improved general driving performance, but did not influence head rotation.",2021,Changes in head rotation at intersections requiring turn in the intervention group did not differ from those in the control group.,"['older Japanese adults', 'Japanese drivers aged between 69 and 87 (Mean\xa0=\xa073.96) years', 'older drivers']","['wait-list control group', 'educational intervention', 'immediate intervention (first wave']","['head rotation', 'general driving performance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.00866078,Changes in head rotation at intersections requiring turn in the intervention group did not differ from those in the control group.,"[{'ForeName': 'Ritsu', 'Initials': 'R', 'LastName': 'Kosuge', 'Affiliation': 'National Research Institute of Police Science, 6-3-1, Kashiwanoha, Kashiwa-shi, Chiba 277-0882, Japan. Electronic address: kosuge@nrips.go.jp.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Okamura', 'Affiliation': 'National Research Institute of Police Science, 6-3-1, Kashiwanoha, Kashiwa-shi, Chiba 277-0882, Japan. Electronic address: okamura@nrips.go.jp.'}, {'ForeName': 'Yukako', 'Initials': 'Y', 'LastName': 'Nakano', 'Affiliation': 'National Research Institute of Police Science, 6-3-1, Kashiwanoha, Kashiwa-shi, Chiba 277-0882, Japan. Electronic address: nakano@nrips.go.jp.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Fujita', 'Affiliation': 'National Research Institute of Police Science, 6-3-1, Kashiwanoha, Kashiwa-shi, Chiba 277-0882, Japan. Electronic address: fujita@nrips.go.jp.'}]",Accident; analysis and prevention,['10.1016/j.aap.2021.106460']
2263,34736394,An individualized telephone-based care support program for rural family caregivers of people with dementia: study protocol for a cluster randomized controlled trial.,"BACKGROUND


There are about 9.5 million people with dementia in China. Up to 99% of them are cared for by their family caregivers. Family caregivers are confronted with considerable difficulties and challenges while providing care. They often experience high levels of emotional, physical, financial, and social burdens. Caregivers in rural areas experience an even higher level of burden compared to their counterparts in urban areas due to fewer health resources for dementia care. However, so far, no intervention study has been conducted to support family caregivers in rural areas of China. The aim of this proposed study is to adapt and evaluate an evidence-based and culturally-tailored individualized telephone-based care support (ITBCS) program for family caregivers of people with dementia in rural China.
METHODS


A cluster randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of the ITBCS compared with usual care for Chinese rural family caregivers of people with dementia. A total sample of 168 rural family caregivers will be recruited. The intervention components consist of a 3-month intensive telephone-based care support intervention followed by telephone-based follow-up consultations for 6 months. The control group will receive usual care services available for them. Outcome measures include carers' subjective burden, depressive symptoms, health-related quality of life, social support, caregiving self-efficacy, and care recipients' difficult behaviours and competence in activities of daily living at 3, 9 and 15 months after baseline. The potential cost-effectiveness of the ITBCS compared with usual care will be assessed as well.
DISCUSSION


If effective, the ITBCS program can be adapted and used in rural areas of China as a blueprint to improve the quality of home-based care for people with dementia. Findings from the present study are significant for developing evidence-based dementia care policy in rural China.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR2000038821 , Registered 4 April 2020, http://www.chictr.org.cn/showprojen.aspx?proj=62268 .",2021,Caregivers in rural areas experience an even higher level of burden compared to their counterparts in urban areas due to fewer health resources for dementia care.,"['family caregivers in rural areas of China', 'rural family caregivers of people with dementia', 'Chinese rural family caregivers of people with dementia', '168 rural family caregivers will be recruited', 'family caregivers of people with dementia in rural China', '9.5 million people with dementia in China', 'people with dementia']","['culturally-tailored individualized telephone-based care support (ITBCS) program', 'ITBCS', 'individualized telephone-based care support program', 'intensive telephone-based care support intervention followed by telephone-based follow-up consultations for 6 months']","[""carers' subjective burden, depressive symptoms, health-related quality of life, social support, caregiving self-efficacy, and care recipients' difficult behaviours and competence in activities of daily living""]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C1881839', 'cui_str': '1000000'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0422322', 'cui_str': 'Follow-up consultation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",168.0,0.063479,Caregivers in rural areas experience an even higher level of burden compared to their counterparts in urban areas due to fewer health resources for dementia care.,"[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Xiang Ya School of Nursing, Central South University, Changsha, Hunan Province, China. yaowang0428@163.com.'}, {'ForeName': 'Lily Dongxia', 'Initials': 'LD', 'LastName': 'Xiao', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Xiang Ya School of Nursing, Central South University, Changsha, Hunan Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Xiang Ya School of Nursing, Central South University, Changsha, Hunan Province, China.'}, {'ForeName': 'Minhui', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Xiang Ya School of Nursing, Central South University, Changsha, Hunan Province, China.'}]",BMC geriatrics,['10.1186/s12877-021-02575-2']
2264,34736367,Analysis by region of outcomes for patients with advanced renal cell carcinoma treated with cabozantinib or everolimus: a sub-analysis of the METEOR study.,"INTRODUCTION


METEOR was a phase 3 trial (NCT01865747) of cabozantinib versus everolimus in adults with advanced or metastatic clear cell RCC previously treated with VEGF receptor (VEGFR) tyrosine kinase inhibitors (TKIs). This  post hoc  analysis of METEOR compared outcomes for patients recruited from European and non-European countries.
MATERIAL AND METHODS


Adults with advanced/metastatic clear cell RCC who had received ≥ 1 prior VEGFR-TKI treatment were randomized 1:1 to receive cabozantinib or everolimus. Patients were categorized by recruitment region: Europe or outside of Europe (rest of world [RoW]). Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and adverse events (AEs) were compared between regional subgroups.
RESULTS


In total, there were 320 eligible patients from Europe (cabozantinib, 167; everolimus, 153) and 338 from RoW (North America, 240 patients; Asia-Pacific, 86; Latin America, 12; randomized as cabozantinib, 163; everolimus, 175). PFS and OS were longer with cabozantinib than with everolimus and similar for the Europe and RoW subgroups. For PFS, the hazard ratio (HR) for cabozantinib versus everolimus was 0.54 for the Europe subgroup ( p  < .001) and 0.50 for the RoW subgroup ( p  < .001). For OS, the HR was 0.75 for the Europe subgroup ( p  = .034) and 0.69 for the RoW subgroup ( p  = .006). ORR in the Europe subgroup was 15% for cabozantinib and 3.9% for everolimus ( p  < .001). For the RoW subgroup, ORR was 20% for cabozantinib and 2.9% for everolimus ( p  < .001). Incidence of grade 3/4 AEs were similar for the Europe (cabozantinib, 74%; everolimus, 58%) and RoW subgroups (cabozantinib, 69%; everolimus, 64%).
CONCLUSION


In the METEOR trial, efficacy outcomes for patients recruited from European and non-European countries favored cabozantinib over everolimus. The efficacy and safety results for the regional subgroups were consistent with those of the overall METEOR population.",2021,PFS and OS were longer with cabozantinib than with everolimus and similar for the Europe and RoW subgroups.,"['Adults with advanced/metastatic clear cell RCC who had received ≥ 1 prior VEGFR', 'patients recruited from European and non-European countries favored cabozantinib over everolimus', 'Patients were categorized by recruitment region: Europe or outside of Europe (rest of world [RoW', '320 eligible patients from Europe (cabozantinib, 167; everolimus, 153) and 338 from RoW (North America, 240 patients; Asia-Pacific, 86; Latin America, 12; randomized as cabozantinib, 163; everolimus, 175', 'patients with advanced renal cell carcinoma treated with', 'adults with advanced or metastatic clear cell RCC previously treated with', 'patients recruited from European and non-European countries']","['VEGF receptor (VEGFR) tyrosine kinase inhibitors (TKIs', 'cabozantinib or everolimus', 'cabozantinib versus everolimus']","['ORR', 'Incidence of grade 3/4 AEs', 'Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and adverse events (AEs', 'efficacy and safety', 'PFS and OS', 'hazard ratio (HR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",320.0,0.180604,PFS and OS were longer with cabozantinib than with everolimus and similar for the Europe and RoW subgroups.,"[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Schmidinger', 'Affiliation': 'Department of Urology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': ""Institut de Cancérologie de l'Ouest, Saint-Herblain, France.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Staehler', 'Affiliation': 'Department of Urology, Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rink', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Retz', 'Affiliation': 'Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csoszi', 'Affiliation': 'Jász-Nagykun-Szolnok County Hospital, Szolnok, Hungary.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'McCaffrey', 'Affiliation': 'Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Caserta', 'Affiliation': 'Medical and Translational Oncology Unit, Azienda Ospedaliera Santa Maria, Terni, Italy.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Duran', 'Affiliation': 'Medical Oncology Department, Hospital Universitario Marques de Valdecilla (IDIVAL), Santander, Spain.'}, {'ForeName': 'Fawzi', 'Initials': 'F', 'LastName': 'Benzaghou', 'Affiliation': 'Ipsen Bioscience, Oncology R&D, Cambridge, MA, USA.'}, {'ForeName': 'Douglas O', 'Initials': 'DO', 'LastName': 'Clary', 'Affiliation': 'Exelixis Inc., Alameda, CA, USA.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Medical Oncology, Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'MD Anderson Cancer Center Hospital, The University of Texas, Houston, TX, USA.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2021.1995041']
2265,34738909,The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial.,"BACKGROUND


Cancer is a chronic disease with an incidence of 24.5 million and 9.6 million deaths worldwide in 2017. Lung and colorectal cancer are the most common cancers for both sexes and, according to national and international recommendations, platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting (CINV) may persist. Moreover, cancer patients are increasingly interested in alternative and complementary medicines and have expressed the desire that nonpharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology significantly decreases the severity of CINV in patients with breast cancer.
OBJECTIVE


The primary aim of this study was to assess the benefits of foot reflexology as a complement therapy to conventional treatments regarding the severity of acute CINV in patients with digestive or lung cancer. The secondary objectives assessed were the frequency and severity of delayed CINV, quality of life, anxiety, and self-esteem.
METHODS


This study was conducted between April 2018 and April 2020 in the Hospices Civils de Lyon, France. This was an open-label randomized controlled trial. Participants were randomized into two groups: the intervention group (ie, conventional care with foot reflexology; n=40) and the control group (ie, conventional care without foot reflexology; n=40). Foot reflexology sessions (30 minutes each) were performed on outpatients or inpatients. Eligible participants were patients with lung or digestive cancer with an indication for platinum-based chemotherapy.
RESULTS


The severity of acute nausea and vomiting was assessed with a visual analog scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for the control group (7/34, 21%; P=.001). Across all cycles, the foot reflexology group showed a trend toward less frequent delayed nausea (P=.28), a significantly less frequent consumption of antiemetic drugs (P=.04), and no significant difference for vomiting (P=.99); there was a trend toward a perception of stronger severity for delayed nausea in the control group (P=.39). Regarding quality of life and anxiety, there was no significant difference between the intervention group and the control group (P=.32 and P=.53, respectively).
CONCLUSIONS


This study's results indicate that foot reflexology provides significantly better management of acute nausea severity and decreased consumption of antiemetic drugs in patients with lung or digestive cancer. In order to fulfill patients' desires to use nonpharmacological treatments and complementary and alternative medicines in hospitals, foot reflexology could be provided as a complementary intervention to conventional antiemetic drugs. Foot reflexology did not result in adverse effects. To assess the benefits of foot reflexology in routine practice, a larger study with several health care centers would be needed with a cluster randomized controlled trial.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03508180; https://clinicaltrials.gov/ct2/show/NCT03508180.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/17232.",2021,"Across all cycles, the foot reflexology group showed a trend toward less frequent delayed nausea (P=.28), a significantly less frequent consumption of antiemetic drugs (P=.04), and no significant difference for vomiting (P=.99); there was a trend toward a perception of stronger severity for delayed nausea in the control group (P=.39).","['Eligible participants were patients with lung or digestive cancer with an indication for platinum-based chemotherapy', 'patients with breast cancer', 'patients with lung or digestive cancer', 'patients with digestive or lung cancer', 'April 2018 and April 2020 in the Hospices Civils de Lyon, France', 'cancer patients', 'Patients With Digestive or Lung Cancer']","['Foot Reflexology', 'intervention group (ie, conventional care with foot reflexology; n=40) and the control group (ie, conventional care without foot reflexology', 'Foot reflexology sessions']","['Nausea and Vomiting', 'frequent consumption of antiemetic drugs', 'quality of life and anxiety', 'nausea and vomiting (CINV', 'delayed nausea', 'visual analog scale', 'vomiting', 'adverse effects', 'severity of acute nausea and vomiting', 'frequency and severity of delayed CINV, quality of life, anxiety, and self-esteem', 'severity of CINV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",,0.0623502,"Across all cycles, the foot reflexology group showed a trend toward less frequent delayed nausea (P=.28), a significantly less frequent consumption of antiemetic drugs (P=.04), and no significant difference for vomiting (P=.99); there was a trend toward a perception of stronger severity for delayed nausea in the control group (P=.39).","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Murat-Ringot', 'Affiliation': 'Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Pierre Jean', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Subtil', 'Affiliation': 'Pôle Santé Publique - Service de Biostatistiques, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Pôle Santé Publique - Service de Biostatistiques, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Preau', 'Affiliation': 'Groupe de Recherche en Psychologie Sociale EA 4163, Institut de Psychologie, Université Lyon 2, Bron, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Piriou', 'Affiliation': 'Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.'}]",JMIR cancer,['10.2196/25648']
2266,34738896,Arthroscopic versus Mini-Open Rotator Cuff Repair: Should We Ignore the Mini-Open Surgery?,"PURPOSE OF THE STUDY To compare the functional and radiological results of the total arthroscopic treatment (TAT) performed due to the rotator cuff (RC) tear problem with the results of the arthroscopically assisted mini-open surgery (AAMOS). MATERIAL AND METHODS This study conducted over a two-year period included all had TAT or AAMOS. Patients were included in the study if they had undergone arthroscopic or mini-open rotator cuff repair, with a minimum of 2 years' follow-up. Patients were divided into two groups in terms of the surgical technique performed. Patients who had TAT was included into the group 1 and, AAMOS group 2. Exclusion criteria included other significant intra-articular pathology such as SLAP lesions or glenohumeral arthrosis, previous rotator cuff surgery, massive rotator cuff tears (>5 cm), and neurologic disorders such as brachial plexopathy or suprascapular neuropathy. Every patient underwent magnetic resonance imaging evaluation before surgery and at last follow-up after surgery. Acromion typed of patients were recorded. Patients were questioned for ASES and Constant score. RESULTS Fifty-eight shoulders were included in the study. Twenty-eight patients were female and 30 were male. The mean age was 55.63 ± 8.06 years. Both groups had 29 patients per each. Mean follow-up period was 26.26 ± 11.46 months. There was no statistically significant difference between the mean age and gender distribution of the groups (p > 0.05). No statistically significant difference in the follow-up period between two groups (p > 0.05). No statistically significant difference was found between the postoperative ASES measurements between the two groups (p > 0.05). There was no statistically significant difference in postoperative Constant measurements between the two groups (p > 0.05). There was no statistically significant difference between the Acromion types between the two groups (p > 0.05). No statistically significant difference was found between the both groups in terms of accompanying shoulder pathology and AC joint degeneration (p > 0.05). In the postoperative MRIs of the patients, 7 patients in the Group 2 and 6 patients in the Group 1 were found to have recurrent tears. No statistically significant difference was found (p > 0.05). DISCUSSION When compared their patients who underwent RC repair by AAMOS intervention with those treated with TAT intervention and stated that the results were satisfactory for both groups and close to each other during their 2-year follow-up regardless of the tear diameter. Rotator cuff repairing with TAT is becoming a popular method of shoulder surgery. Initial reports of outcomes with this technique have indicated similar results when compared with open techniques, with less perioperative morbidity. Patients with RC tears treated by TAR, the shoulder range of motion was achieved in a shorter time and the rate of development of fibrous ankylosis was found to be lower. We performed the same configuration for the repair technique that may avoid to differ the results. Additionlay, all patients in study had the same rehabilitation protocol not to differ the results. Our study demonstrated similar results, with no differences noted in clinical outcomes between the TAT and the AAMOS for all scoring scales evaluated. Our experience with TAT notes a steep learning curve for proper technique. Certainly, surgeons may attempt a TAT, knowing that the patient's long-term outcome will not differ if the AAMOS is needed. CONCLUSIONS It must be kept in mind that both surgical methods may provide satisfactory results; the decision regarding which method should be used must be based on the skills, experience and technical oppurtunities of the orthopedic surgeon. However, any of the surgical technique is chosen, smilar excellent clinical results can be achieved. Key words: rotator cuff, mini-open surgery, total arthroscopic repair, cuff tear, Constant score, ASES score.",2021,No statistically significant difference was found between the postoperative ASES measurements between the two groups (p > 0.05).,"['Fifty-eight shoulders were included in the study', 'Exclusion criteria included other significant intra-articular pathology such as SLAP lesions or glenohumeral arthrosis, previous rotator cuff surgery, massive rotator cuff tears (>5 cm), and neurologic disorders such as brachial plexopathy or suprascapular neuropathy', 'Twenty-eight patients were female and 30 were male', ""Patients were included in the study if they had undergone arthroscopic or mini-open rotator cuff repair, with a minimum of 2 years' follow-up""]","['arthroscopically assisted mini-open surgery (AAMOS', 'TAT', 'magnetic resonance imaging evaluation', 'TAT or AAMOS', 'total arthroscopic treatment (TAT', 'TAR', 'Arthroscopic versus Mini-Open Rotator Cuff Repair', 'TAT intervention', 'Rotator cuff repairing with TAT']","['rate of development of fibrous ankylosis', 'accompanying shoulder pathology and AC joint degeneration', 'postoperative ASES measurements', 'postoperative Constant measurements', 'Acromion types', 'perioperative morbidity', 'Key words: rotator cuff, mini-open surgery, total arthroscopic repair, cuff tear, Constant score, ASES score']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0700251', 'cui_str': 'Brachial plexus disorder'}, {'cui': 'C3662000', 'cui_str': 'Suprascapular neuropathy'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039315', 'cui_str': 'Tar'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332791', 'cui_str': 'Fibrous ankylosis'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0001209', 'cui_str': 'Structure of acromion'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",58.0,0.00764331,No statistically significant difference was found between the postoperative ASES measurements between the two groups (p > 0.05).,"[{'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Ozcan', 'Affiliation': 'Ministry of Health, Tatvan State Hospital, Department of Orthopaedics and Traumatology, Bitlis, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Varol', 'Affiliation': 'Ministry of Health, Silopi State Hospital, Department of Orthopaedics and Traumatology, Sirnak, Turkey.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Kilinc', 'Affiliation': 'Health Science University Istanbul Fatih Sultan Mehmet Training and Research Hospital, Department of Orthopaedics and Traumatology, Istanbul, Turkey.'}]",Acta chirurgiae orthopaedicae et traumatologiae Cechoslovaca,[]
2267,34738828,Comparison of a Pure Plug-Based versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial.,"Background:  Transcatheter aortic valve replacement (TAVR) is an established treatment option for patients with severe symptomatic aortic stenosis (AS), and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce.  Methods:  The CHOICE-CLOSURE (Randomized Comparison of CatHeter-based Strategies fOr Interventional ACcess SitE CLOSURE during Transfemoral Transcatheter Aortic Valve Implantation) trial is an investigator-initiated, multicenter study, in which patients undergoing transfemoral TAVR were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex, Wayne, Pennsylvania) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular, Abbott Park, Illinois) potentially complemented by a small-plug. The primary endpoint consisted of access-site or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary endpoints included the rate of access-site or access-related bleeding, VCD failure, and time to hemostasis  Results:  A total of 516 patients were included and randomized. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary endpoint occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk [RR]: 1.61, 95% confidence interval [CI]: 1.07-2.44, p=0.029). Access-site or access-related bleeding occurred in 11.6% vs. 7.4% (RR: 1.58, 95%CI: 0.91-2.73, p=0.133) and device failure in 4.7% vs. 5.4% (RR: 0.86, 95%CI: 0.40-1.82, p=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32, 180] vs. 240 [174, 316] seconds, p<0.001).  Conclusions:  Among patients treated with transfemoral TAVR, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access-site or access-related vascular complications but a shorter time to hemostasis compared to a primary suture-based technique using the ProGlide VCD.",2021,"Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce.  ","['Transfemoral Transcatheter Aortic Valve Replacement', 'Transfemoral Transcatheter Aortic Valve Implantation', 'patients with severe symptomatic aortic stenosis (AS', 'A total of 516 patients were included and randomized', 'patients undergoing transfemoral TAVR']","['CatHeter-based Strategies fOr', 'vascular access site closure using either a pure plug-based technique (MANTA, Teleflex, Wayne, Pennsylvania) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular, Abbott Park, Illinois) potentially complemented by a small-plug', 'dedicated plug-based or suture-based vascular closure device (VCD) strategies', 'transfemoral TAVR', 'Transcatheter aortic valve replacement (TAVR', 'Pure Plug-Based versus a Primary Suture-Based Vascular Closure Device Strategy']","['device failure', 'mean Society of Thoracic Surgeons score', 'rate of access-site or access-related bleeding, VCD failure, and time to hemostasis  Results', 'peripheral vascular disease', 'Time to hemostasis', 'access-site or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria', 'Access-site or access-related bleeding']","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0182324', 'cui_str': 'Plug'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C3504161', 'cui_str': 'Vascular Closure Devices'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0086138', 'cui_str': 'Equipment malfunction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",516.0,0.180316,"Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce.  ","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hartung', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Dumpies', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Obradovic', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Wilde', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Majunke', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boekstegers', 'Affiliation': 'Department of Cardiology, Helios Klinikum Siegburg, Siegburg, Germany; Witten Herdecke University, Witten, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Müller', 'Affiliation': 'Department of Cardiology, Helios Klinikum Siegburg, Siegburg, Germany.'}, {'ForeName': 'Melchior', 'Initials': 'M', 'LastName': 'Seyfarth', 'Affiliation': 'Witten Herdecke University, Witten, Germany; Department of Cardiology, Helios University Hospital Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vorpahl', 'Affiliation': 'Witten Herdecke University, Witten, Germany; Department of Cardiology, Helios University Hospital Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kiefer', 'Affiliation': 'University Department of Cardiac Surgery, Heart Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Noack', 'Affiliation': 'University Department of Cardiac Surgery, Heart Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Leontyev', 'Affiliation': 'University Department of Cardiac Surgery, Heart Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Rotta Detto Loria', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Mitsunobu', 'Initials': 'M', 'LastName': 'Kitamura', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Michael Andrew', 'Initials': 'MA', 'LastName': 'Borger', 'Affiliation': 'University Department of Cardiac Surgery, Heart Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Anne-Kathrin', 'Initials': 'AK', 'LastName': 'Funkat', 'Affiliation': 'Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Hohenstein', 'Affiliation': 'Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Holzhey', 'Affiliation': 'Witten Herdecke University, Witten, Germany; University Department of Cardiac Surgery, Heart Center Leipzig, Leipzig, Germany; Department of Cardiac Surgery, Helios University Hospital Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.121.057856']
2268,34737130,Improved wound healing of diabetic foot ulcers using human placenta-derived mesenchymal stem cells in gelatin electrospun nanofibrous scaffolds plus a platelet-rich plasma gel: A randomized clinical trial.,"AIM


The effectiveness of nanofibers containing human placenta-derived mesenchymal stem cells (hPDMSCs) plus platelet-rich plasma (PRP) for healing of diabetic foot ulcers (DFUs) was investigated.
METHODS


hPDMSCs were isolated from human donor placentas, and cultured in electrospun gelatin nanofibrous scaffolds (GNS). Twenty-eight patients with DFUs were randomized into three groups in a 12-week trial: (A) Treated with hPDMSCs; (B) Treated with hPDMSCs after coating the ulcer with PRP gel; (C) Control group received standard wound care. Wound area and pain freewalkingdistance were measured every 2 weeks.
RESULTS


Flow cytometry showed the expression of mesenchymal markers. SEM images and DAPI staining indicated significantly higher levels of hPDMSC proliferation on GNS after 3 and 7 days of culture. The MTS assay showed a significant increase in proliferation on GNS, compared to controls. Wound size reduction was 66% in group A, 71% in group B, and 36% in control group C. A significant difference in wound closure and pain-free walking distance was observed between groups A and B, compared to control group C (p < 0.05), but no difference between groups A and B. Biopsy of the implanted tissue showed the development of new capillary formation in groups A and B.
CONCLUSION


Implantation of hPDMSCs in GNS accelerated wound healing and improved clinical parameters in DFU patients.",2021,"Wound size reduction was 66% in group A, 71% in group B, and 36% in control group C. A significant difference in wound closure and pain-free walking distance was observed between groups A and B, compared to control group C (p < 0.05), but no difference between groups A and B. Biopsy of the implanted tissue showed the development of new capillary formation in groups A and B.
CONCLUSION


Implantation of hPDMSCs in GNS accelerated wound healing and improved clinical parameters in DFU patients.","['hPDMSCs were isolated from human donor placentas, and cultured in electrospun gelatin nanofibrous scaffolds (GNS', 'Twenty-eight patients with DFUs']","['human placenta-derived mesenchymal stem cells', 'hPDMSCs', 'nanofibers containing human placenta-derived mesenchymal stem cells (hPDMSCs) plus platelet-rich plasma (PRP', 'PRP gel; (C) Control group received standard wound care']","['expression of mesenchymal markers', 'proliferation on GNS', 'wound healing of diabetic foot ulcers', 'wound closure and pain-free walking distance', 'Wound area and pain freewalkingdistance', 'wound healing and improved clinical parameters', 'Wound size reduction']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C1881960', 'cui_str': 'Nanofibers'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0886052', 'cui_str': 'Wound care'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",28.0,0.0130164,"Wound size reduction was 66% in group A, 71% in group B, and 36% in control group C. A significant difference in wound closure and pain-free walking distance was observed between groups A and B, compared to control group C (p < 0.05), but no difference between groups A and B. Biopsy of the implanted tissue showed the development of new capillary formation in groups A and B.
CONCLUSION


Implantation of hPDMSCs in GNS accelerated wound healing and improved clinical parameters in DFU patients.","[{'ForeName': 'Rokhsareh', 'Initials': 'R', 'LastName': 'Meamar', 'Affiliation': 'Isfahan Clinical Toxicology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: meamar@pharm.mui.ac.ir.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Ghasemi-Mobarakeh', 'Affiliation': 'Department of Textile Engineering, Isfahan University of Technology, Isfahan 84156-83111, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Norouzi', 'Affiliation': 'Department of Textile Engineering, Isfahan University of Technology, Isfahan 84156-83111, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Siavash', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Hamblin', 'Affiliation': 'Laser Research Centre, Faculty of Health Science, University of Johannesburg, Doornfontein 2028, South Africa.'}, {'ForeName': 'Mehrafarin', 'Initials': 'M', 'LastName': 'Fesharaki', 'Affiliation': 'Isfahan Clinical Toxicology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",International immunopharmacology,['10.1016/j.intimp.2021.108282']
2269,34733357,The Impact of Depressive Symptoms on Response to Integrated Cognitive Behavioral Therapy for Substance Use Disorders and Intimate Partner Violence.,"Purpose


Past studies demonstrated the efficacy of integrated cognitive-behavioral therapy (CBT) for substance use disorder (SUD) and intimate partner violence (IPV) as well as high rates of depressive symptoms in this population. However, little is known about how depressive symptoms impact treatment outcomes. We hypothesized that integrated CBT, but not standard drug counseling (DC), would buffer the negative effects of depressive symptoms on treatment response.
Design/methodology/approach


A secondary analysis of a randomized trial compared men assigned to 12 weeks of integrated CBT for SUD and IPV ( n =29) to those in DC ( n =34).
Findings


Most (60%) of the sample reported any depressive symptoms. Controlling for baseline IPV, reporting any depressive symptoms was associated with more positive cocaine screens during treatment. Among men with depressive symptoms, integrated CBT but not DC was associated with fewer positive cocaine screens. Controlling for baseline alcohol variables, integrated CBT and depressive symptoms were each associated with less aggression outside of intimate relationships (e.g., family, strangers) during treatment. For men  without  depressive symptoms, integrated CBT was associated with less non-IPV aggression compared to DC. Effects were not significant for other substances, IPV, or at follow-up.
Originality


Although integrated CBT's efficacy for improving SUD and IPV has been established, moderators of treatment response have not been investigated.
Practical Implications


Integrated CBT buffered depressive symptoms' impact on cocaine use, yet only improved non-IPV aggression in men without depressive symptoms.
Research Limitations/Implications


This study found some evidence for differential response to CBT by depressive symptoms on cocaine and aggression at end of treatment, which did not persist three months later. Future studies should explore mechanisms of integrated CBT for SUD and IPV, including mood regulation, on depressive symptoms in real-world samples.",2021,"For men  without  depressive symptoms, integrated CBT was associated with less non-IPV aggression compared to DC.","[' n =29) to those in DC ( n =34', 'Substance Use Disorders and Intimate Partner Violence', 'men without depressive symptoms']","['integrated cognitive-behavioral therapy (CBT', 'integrated CBT for SUD and IPV', 'Integrated Cognitive Behavioral Therapy']",['depressive symptoms'],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0511342,"For men  without  depressive symptoms, integrated CBT was associated with less non-IPV aggression compared to DC.","[{'ForeName': 'Lourah M', 'Initials': 'LM', 'LastName': 'Kelly', 'Affiliation': 'Rochester Institute of Technology, College of Health Sciences and Technology, 153 Lomb Memorial Drive, Rochester, NY, 14623.'}, {'ForeName': 'Cory A', 'Initials': 'CA', 'LastName': 'Crane', 'Affiliation': 'Rochester Institute of Technology, College of Health Sciences and Technology, 153 Lomb Memorial Drive, Rochester, NY, 14623.'}, {'ForeName': 'Kristyn', 'Initials': 'K', 'LastName': 'Zajac', 'Affiliation': 'University of Connecticut School of Medicine, 263 Farmington Ave, Farmington, CT, 06030.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Easton', 'Affiliation': 'Rochester Institute of Technology, College of Health Sciences and Technology, 153 Lomb Memorial Drive, Rochester, NY, 14623.'}]",Advances in dual diagnosis,['10.1108/add-09-2020-0020']
2270,34739637,The effect of metformin when combined with neoadjuvant chemotherapy in breast cancer patients.,"Metformin has been used to treat type 2 Diabetes Mellitus since long time. It has two proposed anti-neoplastic mechanisms, direct (insulin-independent) and indirect (insulin-dependent) actions. To assess the effect of Metformin on pathological response when combined with neoadjuvant chemotherapy in breast cancer. A prospective study included stage II, III non-diabetic breast cancer patients who received neoadjuvant chemotherapy in our center during the period from May 2017 to March 2019. 59 patients met our inclusion criteria and completed the study, 27 patients received 850 mg Metformin every 12 h with chemotherapy (group A), and 32 patients received chemotherapy without Metformin (group B). Pathological response was assessed by Chevallier classification and residual cancer burden score (RCB). Both groups were well balanced regarding baseline characteristics. The results of our study showed that the rate of pathological complete response (pCR) was 14.8% in group (A) vs. 6.3% in group (B) with a P value of 0.39. RCB class 3 was 40.7% in group (A) vs. 68.8% in group (B) which was statistically significant with a (P value of 0.031). Patients with triple-positive histology who had RCB class 3 were only (14.3%) in group (A) versus (60%) in group B. Patients with body mass index (BMI) ≥ 25 who had RCB 3 were 40% and 66.7% in group (A) and (B), respectively. Metformin may increase the pCR especially in patients with BMI ≥ 25 and patients with triple-positive histology, a larger phase III study is needed to confirm this finding.",2021,RCB class 3 was 40.7% in group (A) vs. 68.8% in group (B) which was statistically significant with a (P value of 0.031).,"['breast cancer', '59 patients met our inclusion criteria and completed the study, 27 patients received 850\xa0mg', 'breast cancer patients', 'stage II, III non-diabetic breast cancer patients who received neoadjuvant chemotherapy in our center during the period from May 2017 to March 2019']","['Metformin', 'chemotherapy', 'chemotherapy without Metformin', 'neoadjuvant chemotherapy', 'metformin']","['Chevallier classification and residual cancer burden score (RCB', 'rate of pathological complete response (pCR', 'RCB class 3', 'pathological response', 'Pathological response', 'pCR']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0347984', 'cui_str': 'During'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C2919269', 'cui_str': 'Residual cancer burden score'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]",,0.0390207,RCB class 3 was 40.7% in group (A) vs. 68.8% in group (B) which was statistically significant with a (P value of 0.031).,"[{'ForeName': 'Shaimaa M', 'Initials': 'SM', 'LastName': 'El-Khayat', 'Affiliation': 'Clinical Oncology Department, Medical Research Institute, Alexandria University, 169 El-hureya Street, Qism Bab Sharqi, Alexandria, Alexandria Governorate, Egypt. shaymaa.elkhayat@alexu.edu.eg.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abouegylah', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Abdallah', 'Affiliation': 'Pathology Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Ahmed Gaber', 'Initials': 'AG', 'LastName': 'Geweil', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Elenbaby', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Omar Shebl', 'Initials': 'OS', 'LastName': 'Zahra', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}]","Medical oncology (Northwood, London, England)",['10.1007/s12032-021-01599-3']
2271,34656205,Comprehensive Behavioral (ComB) Treatment of Trichotillomania: A Randomized Clinical Trial.,"OBJECTIVE


This study is the first controlled trial of comprehensive behavioral (ComB) treatment of trichotillomania (TTM). ComB provides individualized treatment based on factors triggering and maintaining hair pulling.
METHOD


Participants (N = 36) were adults (M = 34.08 years old, SD = 12.26) meeting DSM5 criteria for TTM. A majority were female (80%) and Caucasian (75%), whereas 17% were African American and 19% Hispanic/Latinx. In a parallel-group design, participants were randomly assigned to (a) Immediate ComB (12 sessions) or (b) Minimal Attention Control (MAC), followed by delayed ComB after week 12. Follow-up continued through week 38. Primary outcomes were self-report (Massachusetts General Hospital Hair pulling Scale; MGH-HPS) and interviewer-rated (NIMH-Trichotillomania Impact Scale and Trichotillomania Severity Scale; TIS/TSS) TTM symptom severity, as well as diagnosis (Trichotillomania Diagnostic Interview).
RESULTS


Immediate efficacy of ComB (vs. MAC) was statistically significant (p = .03) for self-reported symptoms, with an effect size d = -.78, but not significant for interviewer-rated symptoms or diagnostic status. Immediate ComB was significantly more likely than MAC (27% vs. 0%) to lead to complete abstinence from hair pulling at week 12. Follow-ups showed good maintenance of effects.
CONCLUSIONS


Efficacy of ComB was established for self-reported symptoms. Future research is needed to establish whether the lack of more widespread effects stems from limitations of the model or to a need for more extensive therapist training, as secondary analyses suggested stronger results among therapists with more TTM experience.",2021,"Immediate efficacy of ComB (vs. MAC) was statistically significant (p = .03) for self-reported symptoms, with an effect size d = -.78, but not significant for interviewer-rated symptoms or diagnostic status.","['A majority were female (80%) and Caucasian (75%), whereas 17% were African American and 19% Hispanic/Latinx', 'Participants (N\u202f=\u202f36) were adults (M\u202f=\u202f34.08 years old, SD\u202f=\u202f12.26) meeting DSM5 criteria for TTM']","['ComB (vs. MAC', 'Comprehensive Behavioral (ComB) Treatment of Trichotillomania', 'Immediate ComB (12 sessions) or (b) Minimal Attention Control (MAC', 'comprehensive behavioral (ComB) treatment of trichotillomania (TTM', 'MAC']","['self-report (Massachusetts General Hospital Hair pulling Scale; MGH-HPS) and interviewer-rated (NIMH-Trichotillomania Impact Scale and Trichotillomania Severity Scale; TIS/TSS', 'TTM symptom severity, as well as diagnosis (Trichotillomania Diagnostic Interview', 'Immediate ComB']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242994', 'cui_str': 'Disease due to Hantanvirus'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0027466', 'cui_str': 'National Institute of Mental Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0475413', 'cui_str': 'Tis category'}, {'cui': 'C0600327', 'cui_str': 'Toxic shock syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",36.0,0.0489133,"Immediate efficacy of ComB (vs. MAC) was statistically significant (p = .03) for self-reported symptoms, with an effect size d = -.78, but not significant for interviewer-rated symptoms or diagnostic status.","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Carlson', 'Affiliation': 'American University.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Malloy', 'Affiliation': 'American University.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Brauer', 'Affiliation': 'University of Chicago.'}, {'ForeName': 'Ruth Goldfinger', 'Initials': 'RG', 'LastName': 'Golomb', 'Affiliation': 'Behavior Therapy Center of Greater Washington.'}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Grant', 'Affiliation': 'University of Chicago.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Mansueto', 'Affiliation': 'Behavior Therapy Center of Greater Washington.'}, {'ForeName': 'David A F', 'Initials': 'DAF', 'LastName': 'Haaga', 'Affiliation': 'American University. Electronic address: dhaaga@american.edu.'}]",Behavior therapy,['10.1016/j.beth.2021.05.007']
2272,34741472,Bifidobacterium bifidum TMC3115 ameliorates milk protein allergy in by affecting gut microbiota: A randomized double-blind control trial.,,2021,,['by affecting gut microbiota'],['Bifidobacterium\xa0bifidum TMC3115'],[],"[{'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]","[{'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}]",[],,0.549793,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jing', 'Affiliation': 'Department of Pediatric, Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun, China.'}, {'ForeName': 'Qingbin', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Pediatric, Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatric, Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun, China.'}]",Journal of food biochemistry,['10.1111/jfbc.13591']
2273,34741328,Letter: a randomised clinical trial comparing the effects of pregabalin with those of placebo on functional dyspepsia. Authors' reply.,,2021,,[],"['pregabalin', 'placebo']",['functional dyspepsia'],[],"[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}]",,0.189656,,"[{'ForeName': 'Nithi', 'Initials': 'N', 'LastName': 'Thinrungroj', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Isariyaphong', 'Initials': 'I', 'LastName': 'Kotikula', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Pinyopornpanish', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16667']
2274,34741323,Letter: a randomised clinical trial comparing the effects of pregabalin with those of placebo on functional dyspepsia.,,2021,,[],"['pregabalin', 'placebo']",['functional dyspepsia'],[],"[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}]",,0.232251,,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Renmin Hospital of Wuhan University, Wuhan, P.R. China.'}, {'ForeName': 'Fuchao', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Dongfeng Hospital, Hubei University of Medicine, Shiyan, P.R. China.'}, {'ForeName': 'Jiexin', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': 'Department of Endocrinology, Renmin Hospital of Wuhan University, Wuhan, P.R. China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Pharmacy, Renmin Hospital of Wuhan University, Wuhan, P.R. China.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Benhong', 'Affiliation': 'Department of Pharmacy, Renmin Hospital of Wuhan University, Wuhan, P.R. China.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16650']
2275,34656197,Who Benefits From a Cognitive vs. Behavioral Approach to Treating Depression? A Pilot Study of Prescriptive Predictors.,"Although experts have suggested ways that cognitive behavioral therapy (CBT) of depression might be personalized for individual clients, there has been little empirical examination of this issue. We examine cognitive behavioral skills and vulnerabilities (i.e., dysfunctional thinking, behavioral inactivation, and avoidance) as potential prescriptive predictors to cognitive vs. behavioral interventions. Forty-two adults with major depressive disorder were randomized to eight weeks of cognitive-only (n = 21) or behavioral-only (n = 21) individual psychotherapy. Clients completed pre-treatment measures of cognitive and behavioral skills and vulnerabilities. Dropout rates were comparable across treatments (21% overall). Treatment outcomes did not differ significantly between treatments (g = .13). Cognitive skills were associated with superior outcomes in the behavioral-only treatment, but additional analyses suggested general skillfulness (i.e., the tendency to have high scores across cognitive and behavioral assessments), rather than cognitive skills per se, predicted a larger response to behavioral interventions. Similarly, behavioral avoidance of social and non-social domains were associated with worse outcomes in the behavioral-only treatment, indicating that behavioral approaches yield less positive outcomes for clients high in behavioral avoidance. If replicated, the results of this pilot study suggest ways that a cognitive behavioral therapist could select intervention strategies to suit individual clients and thereby improve treatment outcomes.",2021,"Similarly, behavioral avoidance of social and non-social domains were associated with worse outcomes in the behavioral-only treatment, indicating that behavioral approaches yield less positive outcomes for clients high in behavioral avoidance.",['Forty-two adults with major depressive disorder'],"['behavioral-only (n = 21) individual psychotherapy', 'cognitive behavioral therapist', 'cognitive behavioral therapy (CBT']","['Dropout rates', 'behavioral avoidance of social and non-social domains', 'cognitive and behavioral skills and vulnerabilities', 'Cognitive skills', 'cognitive behavioral skills and vulnerabilities (i.e., dysfunctional thinking, behavioral inactivation, and avoidance']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",42.0,0.0218655,"Similarly, behavioral avoidance of social and non-social domains were associated with worse outcomes in the behavioral-only treatment, indicating that behavioral approaches yield less positive outcomes for clients high in behavioral avoidance.","[{'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Murphy', 'Affiliation': 'The Ohio State University.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Cooper', 'Affiliation': 'The Ohio State University.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Hollars', 'Affiliation': 'The Ohio State University.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Strunk', 'Affiliation': 'The Ohio State University. Electronic address: strunk.20@osu.edu.'}]",Behavior therapy,['10.1016/j.beth.2021.03.012']
2276,34656190,Acceptability and Preliminary Effects of a Mindfulness Mobile Application for Ruminative Adolescents.,"Rumination is a transdiagnostic risk factor that appears to be reduced through mindfulness interventions. However, mindfulness mobile apps have not been tested for their effects on rumination, especially among adolescents. Thus, we aimed to test the acceptability and effects of a mindfulness mobile intervention among ruminative adolescents using a within-subjects pretest/posttest design. Participants were 80 adolescents ages 12-15, selected for moderate-to-high rumination (M age = 14.01, SD = .99; 46.2% girls; 86.25% White; 3.75% Hispanic). We asked adolescents to use our mindfulness app 3 times per day for 3 weeks. Participants and parents completed questionnaires at baseline, post-intervention, and 6 and 12 weeks later. Acceptability was assessed by tracking app use and asking adolescents and parents to report on their experiences post-intervention. We assessed repetitive negative thinking (i.e., rumination and worry) and internalizing symptoms via self- and parent-report. The intervention demonstrated acceptability, and there were significant reductions in rumination, worry, anxiety and parent-reported internalizing symptoms post-intervention. Effects on rumination, anxiety and internalizing symptoms persisted throughout the 12-week follow-up with large effect sizes using an intention-to-treat approach. Thus, a brief mindfulness mobile app intervention appeared to be both engaging and helpful in reducing negative repetitive thinking and internalizing symptoms among ruminative adolescents. It will be important to test this intervention in a randomized controlled trial to control for effects of time and attention.",2021,"Effects on rumination, anxiety and internalizing symptoms persisted throughout the 12-week follow-up with large effect sizes using an intention-to-treat approach.","['Participants were 80 adolescents ages 12-15, selected for moderate-to-high rumination (M age\u202f=\u202f14.01, SD\u202f=\u202f.99; 46.2% girls; 86.25% White; 3.75% Hispanic', 'ruminative adolescents', 'ruminative adolescents using a within-subjects pretest/posttest design', 'Ruminative Adolescents']","['Mindfulness Mobile Application', 'mindfulness mobile intervention']","['repetitive negative thinking (i.e., rumination and worry) and internalizing symptoms via self- and parent-report', 'Acceptability', 'rumination, worry, anxiety and parent-reported internalizing symptoms', 'rumination, anxiety and internalizing symptoms']","[{'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424134', 'cui_str': 'Pessimistic'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",80.0,0.0472413,"Effects on rumination, anxiety and internalizing symptoms persisted throughout the 12-week follow-up with large effect sizes using an intention-to-treat approach.","[{'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Hilt', 'Affiliation': 'Lawrence University. Electronic address: lori.m.hilt@lawrence.edu.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Swords', 'Affiliation': 'Lawrence University.'}]",Behavior therapy,['10.1016/j.beth.2021.03.004']
2277,34656170,Effects of photobiomodulation and a physical exercise program on the expression of inflammatory and cartilage degradation biomarkers and functional capacity in women with knee osteoarthritis: a randomized blinded study.,"BACKGROUND


The knee osteoarthritis (OA) is a joint disease characterized by degradation of articular cartilage that leads to chronic inflammation. Exercise programs and photobiomodulation (PBM) are capable of modulating the inflammatory process of minimizing functional disability related to knee OA. However, their association on the concentration of biomarkers related to OA development has not been studied yet. The aim of the present study is to investigate the effects of PBM (via cluster) with a physical exercise program in functional capacity, serum inflammatory and cartilage degradation biomarkers in patients with knee OA.
METHODS


Forty-two patients were randomly allocated in 3 groups: ESP: exercise + sham PBM; EAP: exercise + PBM and CG: control group. Six patients were excluded before finished the experimental period. The analyzed outcomes in baseline and 8-week were: the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) and the evaluation of serum biomarkers concentration (IL-1β, IL-6, IL-8, IL-10 e TNF-α, and CTX-II).
RESULTS


An increase in the functional capacity was observed in the WOMAC total score for both treated groups (p < 0.001) and ESP presents a lower value compared to CG (p < 0.05) the 8-week post-treatment. In addition, there was a significant increase in IL-10 concentration of EAP (p < 0.05) and higher value compared to CG (p < 0.001) the 8-week post-treatment. Moreover, an increase in IL-1β concentration was observed for CG (p < 0.05). No other difference was observed comparing the other groups.
CONCLUSION


Our data suggest that the physical exercise therapy could be a strategy for increasing functional capacity and in association with PBM for increasing IL-10 levels in OA knee individuals.
TRIAL REGISTRATION


ReBEC (RBR-7t6nzr).",2021,"In addition, there was a significant increase in IL-10 concentration of EAP (p < 0.05) and higher value compared to CG (p < 0.001) the 8-week post-treatment.","['patients with knee OA', 'OA knee individuals', 'women with knee osteoarthritis', 'Forty-two patients']","['Exercise programs and photobiomodulation (PBM', 'photobiomodulation and a physical exercise program', 'physical exercise therapy', 'PBM (via cluster) with a physical exercise program', 'ESP: exercise\u2009+\u2009sham PBM; EAP: exercise\u2009+\u2009PBM and CG: control group']","['expression of inflammatory and cartilage degradation biomarkers and functional capacity', 'IL-1β concentration', 'WOMAC total score', 'IL-10 concentration of EAP', 'Western Ontario and McMaster Universities Osteoarthritis (WOMAC) and the evaluation of serum biomarkers concentration (IL-1β, IL-6, IL-8, IL-10 e TNF-α, and CTX-II', 'functional capacity', 'functional capacity, serum inflammatory and cartilage degradation biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319566', 'cui_str': '42'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0015373', 'cui_str': 'Extrasensory perception'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013995', 'cui_str': 'Employee Assistance Programs (Health Care)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0013995', 'cui_str': 'Employee Assistance Programs (Health Care)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}]",42.0,0.0258295,"In addition, there was a significant increase in IL-10 concentration of EAP (p < 0.05) and higher value compared to CG (p < 0.001) the 8-week post-treatment.","[{'ForeName': 'Patricia Gabrielli', 'Initials': 'PG', 'LastName': 'Vassão', 'Affiliation': 'Department of Biosciences, Federal University of São Paulo, Campus Baixada Santista, Rua Silva Jardim, 136, Santos, SP, 11015-020, Brazil. patriciavassao@gmail.com.'}, {'ForeName': 'Ana Carolina Flygare', 'Initials': 'ACF', 'LastName': 'de Souza', 'Affiliation': 'Department of Human Movement Science, Federal University of São Paulo, Campus Baixada Santista, Rua Silva Jardim, 136, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Raquel Munhoz', 'Initials': 'RM', 'LastName': 'da Silveira Campos', 'Affiliation': 'Department of Biosciences, Federal University of São Paulo, Campus Baixada Santista, Rua Silva Jardim, 136, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Livia Assis', 'Initials': 'LA', 'LastName': 'Garcia', 'Affiliation': 'Scientific Institute and Technological Department -University Brazil, São Paulo-Itaquera, SP, Brazil.'}, {'ForeName': 'Helga Tatiana', 'Initials': 'HT', 'LastName': 'Tucci', 'Affiliation': 'Department of Human Movement Science, Federal University of São Paulo, Campus Baixada Santista, Rua Silva Jardim, 136, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Ana Claudia Muniz', 'Initials': 'ACM', 'LastName': 'Renno', 'Affiliation': 'Department of Biosciences, Federal University of São Paulo, Campus Baixada Santista, Rua Silva Jardim, 136, Santos, SP, 11015-020, Brazil.'}]","Advances in rheumatology (London, England)",['10.1186/s42358-021-00220-5']
2278,34662000,"The efficacy of vitamin B6 as an adjunctive therapy to lithium in improving the symptoms of acute mania in patients with bipolar disorder, type 1; a double-blind, randomized, placebo-controlled, clinical trial.","OBJECTIVE


Vitamin B6 has been linked to a variety of probable roles, including anti-inflammatory, homocysteine-lowering, serotonin-regulating, and dopamine-lowering. In this study, we investigated the possible effect of vitamin B6 on bipolar disorder in manic episode with psychotic feature in a placebo-controlled double-blind clinical trial in a psychiatric hospital.
METHODS


This study was performed on 50 patients who were equally divided into two groups (each group included 25 patients) using 80 mg of vitamin B6 daily or placebo. At the beginning and end of the study, they were evaluated for lab tests, inflammatory biomarkers and level of blood homocysteine. Also, at the baseline and in weeks 2, 4, and 8, they were evaluated based on the anthropometric measurements, score obtained from the Young Mania Questionnaire, Mini-Mental State Examination (MMSE), and the Pittsburgh Sleep Questionnaire.
RESULTS


Accordingly, based on Yang Mania scoring scale, no significant difference was observed between the two groups receiving vitamin B6 and placebo (22.68 ± 5.39 vs. 21.80 ± 5.39 [p-value = .51]). Based on MMSE, significant improvement in cognitive status was obtained in group placebo compared to vitamin B6 group (25.24 ± 1.96 vs. 24.40 ± 3.25, respectively [p-value = .01]). At the Pittsburg scale (total, there was no statistically significant difference between the two groups receiving vitamin B6 and placebo (1.04 ± 0.20 vs. 0.48 ± 0.50 [p-value = .23]). Additionally, no significant difference was observed between the two groups regarding the anthropometric status.
CONCLUSIONS


According to this study, the daily dose of 80 mg of vitamin B6 for 8 weeks in patients with bipolar disorder in the manic episode with psychotic feature treated daily with lithium, was not associated with a significant improvement in mood status compared to the control-placebo group. It is recommended to perform similar studies in a multi-center manner with a larger sample size and longer duration.",2021,"RESULTS


Accordingly, based on Yang Mania scoring scale, no significant difference was observed between the two groups receiving vitamin B6 and placebo (22.68 ± 5.39 vs. 21.80 ± 5.39 [p-value = .51]).","['patients with bipolar disorder, type 1', 'patients with bipolar disorder in the manic episode with psychotic feature treated daily with', '50 patients who were equally divided into two groups (each group included 25 patients']","['control-placebo', 'using 80\xa0mg of vitamin B6 daily or placebo', 'vitamin B6 and placebo', 'lithium', 'Vitamin B6', 'placebo', 'vitamin B6']","['mood status', 'lab tests, inflammatory biomarkers and level of blood homocysteine', 'Yang Mania scoring scale', 'anthropometric measurements, score obtained from the Young Mania Questionnaire, Mini-Mental State Examination (MMSE), and the Pittsburgh Sleep Questionnaire', 'cognitive status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0349208', 'cui_str': 'Manic episode, unspecified'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1328359', 'cui_str': 'Blood homocysteine'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",50.0,0.270589,"RESULTS


Accordingly, based on Yang Mania scoring scale, no significant difference was observed between the two groups receiving vitamin B6 and placebo (22.68 ± 5.39 vs. 21.80 ± 5.39 [p-value = .51]).","[{'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Badrfam', 'Affiliation': 'Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed-Ali', 'Initials': 'SA', 'LastName': 'Mostafavi', 'Affiliation': 'Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khaleghi', 'Affiliation': 'Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Zandifar', 'Affiliation': 'Social Determinants of Health Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Farid', 'Affiliation': 'Non communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Nami', 'Initials': 'N', 'LastName': 'Mohammadian Khonsari', 'Affiliation': 'Student Research Committee, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammadi', 'Affiliation': 'Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Brain and behavior,['10.1002/brb3.2394']
2279,34748269,Liver transplant from controlled donation after circulatory death donors with normothermic regional perfusion versus donation after drain death donors.,"We read with great interest the recent article of Ruiz et al.(1) and would like to congratulate the authors. Also, we would like to make some important comments. Ruiz et al. reported the outcomes of liver transplantation (LT) from controlled donation after circulatory death (cDCD) donors with normothermic regional perfusion (NRP) (from 2015 to 2019, 100 patient) versus donation after brain death (DBD) donors (from 2015 to 2019, 200 patients).",2021,"reported the outcomes of liver transplantation (LT) from controlled donation after circulatory death (cDCD) donors with normothermic regional perfusion (NRP) (from 2015 to 2019, 100 patient) versus donation after brain death (DBD) donors (from 2015 to 2019, 200 patients).",['Liver transplant from controlled donation after circulatory death donors with normothermic regional perfusion versus donation after drain death donors'],['normothermic regional perfusion (NRP'],[],"[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}]","[{'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",[],,0.15649,"reported the outcomes of liver transplantation (LT) from controlled donation after circulatory death (cDCD) donors with normothermic regional perfusion (NRP) (from 2015 to 2019, 100 patient) versus donation after brain death (DBD) donors (from 2015 to 2019, 200 patients).","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Savier', 'Affiliation': 'Service de chirurgie digestive et hépato-bilio-pancréatique, transplantation hépatique, CHU Pitié-Salpêtriere, Assistance Publique-Hôpitaux de Paris (AP-HP), Sorbonne Université, Paris, France.'}, {'ForeName': 'Chetana', 'Initials': 'C', 'LastName': 'Lim', 'Affiliation': 'Service de chirurgie digestive et hépato-bilio-pancréatique, transplantation hépatique, CHU Pitié-Salpêtriere, Assistance Publique-Hôpitaux de Paris (AP-HP), Sorbonne Université, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Scatton', 'Affiliation': 'Service de chirurgie digestive et hépato-bilio-pancréatique, transplantation hépatique, CHU Pitié-Salpêtriere, Assistance Publique-Hôpitaux de Paris (AP-HP), Sorbonne Université, Paris, France.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.26363']
2280,34748263,Changes in Bile Acid Subtypes and Long-Term Successful Weight-Loss in Response to Weight-Loss Diets: the POUNDS Lost trial.,"BACKGROUND & AIMS


Primary bile acids (BAs) are synthesized in the liver and secondary BAs result from intestinal microbial activity. Different subtypes of BAs may be involved in regulating adiposity and energy homeostasis. We examined how changes in circulating BA subtypes induced by weight-loss diets were associated with improvements in adiposity, regional fat deposition, and energy metabolism among overweight and obese adults.
METHODS


The study included 551 subjects who participated in a 2-year weight-loss diet intervention trial. Circulating 14 BA subtypes (primary and secondary unconjugated BAs and their taurine-/glycine-conjugates) were measured at baseline and 6 months. Associations of changes in BAs with changes in weight, waist circumference, resting energy expenditure (REE), body fat composition, and fat distribution were evaluated.
RESULTS


Greater decreases in primary BAs (cholate and chenodeoxycholate) and secondary BAs (deoxycholate and lithocholate) and their conjugates (except for glycolithocholate) were associated with more decreases in weight and waist circumference at 6 months (P -after-false-discovery-rate-correction  [P FDR  ] <0.05). We found that changes in glycocholate and glycoursodeoxycholate were consistently associated with reductions of general and central adiposity, REE, whole-body fat, and visceral adipose tissue (P FDR  <0.05). Further, the initial (6-month) changes in BA subtypes were differently predictive of successful weight loss over 2 years.
CONCLUSIONS


The decreases in primary and secondary BA subtypes after eating low-calorie weight-loss diets were significantly associated with improving adiposity, fat accumulation, and energy metabolism, suggesting that specific BA subtypes would be predictive of long-term successful weight loss and individuals' response to the treatment of weight-loss diets.",2021,"The decreases in primary and secondary BA subtypes after eating low-calorie weight-loss diets were significantly associated with improving adiposity, fat accumulation, and energy metabolism, suggesting that specific BA subtypes would be predictive of long-term successful weight loss and individuals' response to the treatment of weight-loss diets.","['551 subjects who participated in a 2-year weight-loss diet intervention trial', 'overweight and obese adults']",[],"['adiposity, fat accumulation, and energy metabolism', 'weight and waist circumference', 'general and central adiposity, REE, whole-body fat, and visceral adipose tissue', 'adiposity, regional fat deposition, and energy metabolism', 'primary BAs (cholate and chenodeoxycholate) and secondary BAs (deoxycholate and lithocholate', 'weight, waist circumference, resting energy expenditure (REE), body fat composition, and fat distribution']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4551560', 'cui_str': 'Central obesity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0086003', 'cui_str': 'Cholates'}, {'cui': 'C0085994', 'cui_str': 'Chenodeoxycholate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086123', 'cui_str': 'Deoxycholate'}, {'cui': 'C0086564', 'cui_str': 'Lithocholate'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",551.0,0.0654751,"The decreases in primary and secondary BA subtypes after eating low-calorie weight-loss diets were significantly associated with improving adiposity, fat accumulation, and energy metabolism, suggesting that specific BA subtypes would be predictive of long-term successful weight loss and individuals' response to the treatment of weight-loss diets.","[{'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Clary B', 'Initials': 'CB', 'LastName': 'Clish', 'Affiliation': 'Metabolomics Platform, Broad Institute of MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.15098']
2281,34748221,Antioxidants to prevent respiratory decline in people with Duchenne muscular dystrophy and progressive respiratory decline.,"BACKGROUND


Duchenne muscular dystrophy (DMD) is an X-linked recessive disorder characterised by progressive muscle weakness beginning in early childhood. Respiratory failure and weak cough develop in all patients as a consequence of muscle weakness leading to a risk of atelectasis, pneumonia, or the need for ventilatory support. There is no curative treatment for DMD. Corticosteroids are the only pharmacological intervention proven to delay the onset and progression of muscle weakness and thus respiratory decline in DMD. Antioxidant treatment has been proposed to try to reduce muscle weakness in general, and respiratory decline in particular.  OBJECTIVES: To assess the effects of antioxidant agents on preventing respiratory decline in people with Duchenne muscular dystrophy during the respiratory decline phase of the condition.  SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two trials registers to 23 March 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) and quasi-RCTs that met our inclusion criteria. We included male patients with a diagnosis of DMD who had respiratory decline evidenced by a forced vital capacity (FVC%) less than 80% but greater than 30% of predicted values, receiving any antioxidant agent compared with other therapies for the management of DMD or placebo.  DATA COLLECTION AND ANALYSIS: Two review authors screened studies for eligibility, assessed risk of bias of studies, and extracted data. We used standard methods expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach. The primary outcomes were FVC and hospitalisation due to respiratory infections. Secondary outcomes were quality of life, adverse events, change in muscle function, forced expiratory volume in the first second (FEV1), and peak expiratory flow (PEF).  MAIN RESULTS: We included one study with 66 participants who were not co-treated with corticosteroids, which was the only study to contribute data to our main analysis. We also included a study that enrolled 255 participants treated with corticosteroids, which was only available as a press release without numerical results. The studies were parallel-group RCTs that assessed the effect of idebenone on respiratory function compared to placebo. The trial that contributed numerical data included patients with a mean (standard deviation) age of 14.3 (2.7) years at the time of inclusion, with a documented diagnosis of DMD or severe dystrophinopathy with clinical features consistent with typical DMD. The overall risk of bias across most outcomes was similar and judged as 'low'.  Idebenone may result in a slightly less of a decline in FVC from baseline to one year compared to placebo (mean difference (MD) 3.28%, 95% confidence interval (CI) -0.41 to 6.97; 64 participants; low-certainty evidence), and probably has little or no effect on change in quality of life (MD -3.80, 95% CI -10.09 to 2.49; 63 participants; moderate-certainty evidence) (Pediatric Quality of Life Inventory (PedsQL), range 0 to 100, 0 = worst, 100 = best quality of life). As a related but secondary outcome, idebenone may result in less of a decline from baseline in FEV1 (MD 8.28%, 95% CI 0.89 to 15.67; 53 participants) and PEF (MD 6.27%, 95% CI 0.61 to 11.93; 1 trial, 64 participants) compared to placebo. Idebenone was associated with fewer serious adverse events (RR 0.42, 95% CI 0.09 to 2.04; 66 participants; low-certainty evidence) and little to no difference in non-serious adverse events (RR 1.00, 95% CI 0.88 to 1.13; 66 participants; low-certainty evidence) compared to placebo. Idebenone may result in little to no difference in change in arm muscle function (MD -2.45 N, 95% CI -8.60 to 3.70 for elbow flexors and MD -1.06 N, 95% CI -6.77 to 4.65 for elbow extensors; both 52 participants) compared to placebo. We found no studies evaluating the outcome hospitalisation due to respiratory infection.  The second trial, involving 255 participants, for which data were available only as a press release without numerical data, was prematurely discontinued due to futility after an interim efficacy analysis based on FVC. There were no safety concerns. The certainty of the evidence was low for most outcomes due to imprecision and publication bias (the lack of a full report of the larger trial, which was prematurely terminated).
AUTHORS' CONCLUSIONS


Idebenone is the only antioxidant agent tested in RCTs for preventing respiratory decline in people with DMD for which evidence was available for assessment. Idebenone may result in slightly less of a decline in FVC and less of a decline in FEV1 and PEF, but probably has little to no measurable effect on change in quality of life. Idebenone is associated with fewer serious adverse events than placebo. Idebenone may result in little to no difference in change in muscle function. Discontinuation due to the futility of the SIDEROS trial and its expanded access programmes may indicate that idebenone research in this condition is no longer needed, but we await the trial data. Further research is needed to establish the effect of different antioxidant agents on preventing respiratory decline in people with DMD during the respiratory decline phase of the condition.",2021,"Idebenone was associated with fewer serious adverse events (RR 0.42, 95% CI 0.09 to 2.04; 66 participants; low-certainty evidence) and little to no difference in non-serious adverse events (RR 1.00, 95% CI 0.88 to 1.13; 66 participants; low-certainty evidence) compared to placebo. ","['66 participants who were not co-treated with corticosteroids, which was the only study to contribute data to our main analysis', 'people with Duchenne muscular dystrophy during the respiratory decline phase of the condition', 'patients\xa0with a mean (standard deviation) age of 14.3 (2.7) years at the time of inclusion,\xa0with a documented diagnosis of DMD or severe dystrophinopathy with clinical features consistent with typical DMD', 'people with Duchenne muscular dystrophy and progressive respiratory decline', 'Embase,\xa0and two trials\xa0registers\xa0to 23 March\xa02021,\xa0together with reference checking, citation searching, and contact with study authors to identify additional studies', 'enrolled 255 participants treated with corticosteroids, which was only available as a press release without numerical results', 'male patients with a diagnosis of DMD who had respiratory decline evidenced by a forced vital capacity (FVC%) less than 80% but greater than 30% of predicted values, receiving any antioxidant agent compared with other therapies for the management of DMD or placebo']","['Corticosteroids', 'Antioxidants', 'Duchenne muscular dystrophy (DMD', 'antioxidant agents', 'Antioxidant treatment', 'placebo']","['quality of life', 'respiratory function', 'quality of life, adverse events, change in muscle function,\xa0forced expiratory volume in the first second (FEV1), and peak expiratory flow (PEF', 'FVC and\xa0hospitalisation due to respiratory infections', 'non-serious adverse events']","[{'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0282424', 'cui_str': 'Press Releases'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0030771', 'cui_str': 'Pefloxacin'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}]",1.0,0.710327,"Idebenone was associated with fewer serious adverse events (RR 0.42, 95% CI 0.09 to 2.04; 66 participants; low-certainty evidence) and little to no difference in non-serious adverse events (RR 1.00, 95% CI 0.88 to 1.13; 66 participants; low-certainty evidence) compared to placebo. ","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garegnani', 'Affiliation': 'Associate Cochrane Centre, Instituto Universitario Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hyland', 'Affiliation': 'Paediatric Neurology Division - Paediatrics Department, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Roson Rodriguez', 'Affiliation': 'Research Department, Instituto Universitario Hospital Italiano, Buenos Aires, Argentina.'}, {'ForeName': 'Camila Micaela E', 'Initials': 'CME', 'LastName': 'Escobar Liquitay', 'Affiliation': 'Central Library, Instituto Universitario Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Juan Va', 'Initials': 'JV', 'LastName': 'Franco', 'Affiliation': 'Associate Cochrane Centre, Instituto Universitario Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013720.pub2']
2282,34748215,Rituximab for people with multiple sclerosis.,"BACKGROUND


Multiple sclerosis (MS) is the most common neurological cause of disability in young adults. Off-label rituximab for MS is used in most countries surveyed by the International Federation of MS, including high-income countries where on-label disease-modifying treatments (DMTs) are available.  OBJECTIVES: To assess beneficial and adverse effects of rituximab as 'first choice' and as 'switching' for adults with MS.
SEARCH METHODS


We searched CENTRAL, MEDLINE, Embase, CINAHL, and trial registers for completed and ongoing studies on 31 January 2021.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) and controlled non-randomised studies of interventions (NRSIs) comparing rituximab with placebo or another DMT for adults with MS.
DATA COLLECTION AND ANALYSIS


We followed standard Cochrane methodology. We used the Cochrane Collaboration's tool for assessing risk of bias. We rated the certainty of evidence using GRADE for: disability worsening, relapse, serious adverse events (SAEs), health-related quality of life (HRQoL), common infections, cancer, and mortality. We conducted separate analyses for rituximab as 'first choice' or as 'switching', relapsing or progressive MS, comparison versus placebo or another DMT, and RCTs or NRSIs.
MAIN RESULTS


We included 15 studies (5 RCTs, 10 NRSIs) with 16,429 participants of whom 13,143 were relapsing MS and 3286 progressive MS. The studies were one to two years long and compared rituximab as 'first choice' with placebo (1 RCT) or other DMTs (1 NRSI), rituximab as 'switching' against placebo (2 RCTs) or other DMTs (2 RCTs, 9 NRSIs). The studies were conducted worldwide; most originated from high-income countries, six from the Swedish MS register. Pharmaceutical companies funded two studies. We identified 14 ongoing studies. Rituximab as 'first choice' for relapsing MS Rituximab versus placebo: no studies met eligibility criteria for this comparison. Rituximab versus other DMTs: one NRSI compared rituximab with interferon beta or glatiramer acetate, dimethyl fumarate, natalizumab, or fingolimod in active relapsing MS at 24 months' follow-up. Rituximab likely results in a large reduction in relapses compared with interferon beta or glatiramer acetate (hazard ratio (HR) 0.14, 95% confidence interval (CI) 0.05 to 0.39; 335 participants; moderate-certainty evidence). Rituximab may reduce relapses compared with dimethyl fumarate (HR 0.29, 95% CI 0.08 to 1.00; 206 participants; low-certainty evidence) and natalizumab (HR 0.24, 95% CI 0.06 to 1.00; 170 participants; low-certainty evidence). It may make little or no difference on relapse compared with fingolimod (HR 0.26, 95% CI 0.04 to 1.69; 137 participants; very low-certainty evidence). The study reported no deaths over 24 months. The study did not measure disability worsening, SAEs, HRQoL, and common infections. Rituximab as 'first choice' for progressive MS One RCT compared rituximab with placebo in primary progressive MS at 24 months' follow-up. Rituximab likely results in little to no difference in the number of participants who have disability worsening compared with placebo (odds ratio (OR) 0.71, 95% CI 0.45 to 1.11; 439 participants; moderate-certainty evidence). Rituximab may result in little to no difference in recurrence of relapses (OR 0.60, 95% CI 0.18 to 1.99; 439 participants; low-certainty evidence), SAEs (OR 1.25, 95% CI 0.71 to 2.20; 439 participants; low-certainty evidence), common infections (OR 1.14, 95% CI 0.75 to 1.73; 439 participants; low-certainty evidence), cancer (OR 0.50, 95% CI 0.07 to 3.59; 439 participants; low-certainty evidence), and mortality (OR 0.25, 95% CI 0.02 to 2.77; 439 participants; low-certainty evidence). The study did not measure HRQoL. Rituximab versus other DMTs: no studies met eligibility criteria for this comparison. Rituximab as 'switching' for relapsing MS  One RCT compared rituximab with placebo in relapsing MS at 12 months' follow-up. Rituximab may decrease recurrence of relapses compared with placebo (OR 0.38, 95% CI 0.16 to 0.93; 104 participants; low-certainty evidence). The data did not confirm or exclude a beneficial or detrimental effect of rituximab relative to placebo on SAEs (OR 0.90, 95% CI 0.28 to 2.92; 104 participants; very low-certainty evidence), common infections (OR 0.91, 95% CI 0.37 to 2.24; 104 participants; very low-certainty evidence), cancer (OR 1.55, 95% CI 0.06 to 39.15; 104 participants; very low-certainty evidence), and mortality (OR 1.55, 95% CI 0.06 to 39.15; 104 participants; very low-certainty evidence). The study did not measure disability worsening and HRQoL.  Five NRSIs compared rituximab with other DMTs in relapsing MS at 24 months' follow-up. The data did not confirm or exclude a beneficial or detrimental effect of rituximab relative to interferon beta or glatiramer acetate on disability worsening (HR 0.86, 95% CI 0.52 to 1.42; 1 NRSI, 853 participants; very low-certainty evidence). Rituximab likely results in a large reduction in relapses compared with interferon beta or glatiramer acetate (HR 0.18, 95% CI 0.07 to 0.49; 1 NRSI, 1383 participants; moderate-certainty evidence); and fingolimod (HR 0.08, 95% CI 0.02 to 0.32; 1 NRSI, 256 participants; moderate-certainty evidence). The data did not confirm or exclude a beneficial or detrimental effect of rituximab relative to natalizumab on relapses (HR 1.0, 95% CI 0.2 to 5.0; 1 NRSI, 153 participants; very low-certainty evidence). Rituximab likely increases slightly common infections compared with interferon beta or glatiramer acetate (OR 1.71, 95% CI 1.11 to 2.62; 1 NRSI, 5477 participants; moderate-certainty evidence); and compared with natalizumab (OR 1.58, 95% CI 1.08 to 2.32; 2 NRSIs, 5001 participants; moderate-certainty evidence). Rituximab may increase slightly common infections compared with fingolimod (OR 1.26, 95% CI 0.90 to 1.77; 3 NRSIs, 5187 participants; low-certainty evidence). It may make little or no difference compared with ocrelizumab (OR 0.02, 95% CI 0.00 to 0.40; 1 NRSI, 472 participants; very low-certainty evidence). The data did not confirm or exclude a beneficial or detrimental effect of rituximab on mortality compared with fingolimod (OR 5.59, 95% CI 0.22 to 139.89; 1 NRSI, 136 participants; very low-certainty evidence) and natalizumab (OR 6.66, 95% CI 0.27 to 166.58; 1 NRSI, 153 participants; very low-certainty evidence). The included studies did not measure SAEs, HRQoL, and cancer.
AUTHORS' CONCLUSIONS


For preventing relapses in relapsing MS, rituximab as 'first choice' and as 'switching' may compare favourably with a wide range of approved DMTs. A protective effect of rituximab against disability worsening is uncertain. There is limited information to determine the effect of rituximab for progressive MS.  The evidence is uncertain about the effect of rituximab on SAEs. They are relatively rare in people with MS, thus difficult to study, and they were not well reported in studies. There is an increased risk of common infections with rituximab, but absolute risk is small.  Rituximab is widely used as off-label treatment in people with MS; however, randomised evidence is weak. In the absence of randomised evidence, remaining uncertainties on beneficial and adverse effects of rituximab for MS might be clarified by making real-world data available.",2021,"Rituximab may reduce relapses compared with dimethyl fumarate (HR 0.29, 95% CI 0.08 to 1.00; 206 participants; low-certainty evidence) and natalizumab (HR 0.24, 95% CI 0.06 to 1.00; 170 participants; low-certainty evidence).","['15 studies (5 RCTs, 10 NRSIs) with 16,429 participants of whom 13,143 were relapsing MS and 3286 progressive MS', 'people with multiple sclerosis', 'people with MS', 'adults with MS', '31 January 2021', 'young adults']","['Rituximab', ""placebo (1 RCT) or other DMTs (1 NRSI), rituximab as 'switching' against placebo"", 'rituximab', 'ocrelizumab', 'rituximab with placebo', 'placebo', 'rituximab with other DMTs', 'rituximab with interferon beta or glatiramer acetate, dimethyl fumarate, natalizumab, or fingolimod', 'HRQoL. Rituximab versus other DMTs', 'placebo or another DMT, and RCTs or NRSIs']","['disability worsening', 'disability worsening, relapse, serious adverse events (SAEs), health-related quality of life (HRQoL), common infections, cancer, and mortality', 'relapse', 'SAEs, HRQoL, and cancer', 'recurrence of relapses', 'disability worsening, SAEs, HRQoL, and common infections', 'mortality']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027183', 'cui_str': 'N,-N-dimethyltryptamine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.417678,"Rituximab may reduce relapses compared with dimethyl fumarate (HR 0.29, 95% CI 0.08 to 1.00; 206 participants; low-certainty evidence) and natalizumab (HR 0.24, 95% CI 0.06 to 1.00; 170 participants; low-certainty evidence).","[{'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Filippini', 'Affiliation': ""Scientific Director's Office, Carlo Besta Foundation and Neurological Institute, Milan, Italy.""}, {'ForeName': 'Jera', 'Initials': 'J', 'LastName': 'Kruja', 'Affiliation': 'Neurology, UHC Mother Theresa, University of Medicine, Tirana, Albania.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Del Giovane', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013874.pub2']
2283,34748214,Dialogue with a conversational agent promotes children's story comprehension via enhancing engagement.,"Dialogic reading, when children are read a storybook and engaged in relevant conversation, is a powerful strategy for fostering language development. With the development of artificial intelligence, conversational agents can engage children in elements of dialogic reading. This study examined whether a conversational agent can improve children's story comprehension and engagement, as compared to an adult reading partner. Using a 2 (dialogic reading or non-dialogic reading) × 2 (agent or human) factorial design, a total of 117 three- to six-year-olds (50% Female, 37% White, 31% Asian, 21% multi-ethnic) were randomly assigned into one of the four conditions. Results revealed that a conversational agent can replicate the benefits of dialogic reading with a human partner by enhancing children's narrative-relevant vocalizations, reducing irrelevant vocalizations, and improving story comprehension.",2021,"This study examined whether a conversational agent can improve children's story comprehension and engagement, as compared to an adult reading partner.","['a total of 117 three- to six-year-olds (50% Female, 37% White, 31% Asian, 21% multi-ethnic']","['conversational agent', '2 (dialogic reading or non-dialogic reading']","[""children's story comprehension and engagement""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]","[{'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0579883,"This study examined whether a conversational agent can improve children's story comprehension and engagement, as compared to an adult reading partner.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'School of Education, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Aubele', 'Affiliation': 'School of Education, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Vigil', 'Affiliation': 'School of Education, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Andres S', 'Initials': 'AS', 'LastName': 'Bustamante', 'Affiliation': 'School of Education, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Young-Suk', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'School of Education, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Warschauer', 'Affiliation': 'School of Education, University of California, Irvine, Irvine, California, USA.'}]",Child development,['10.1111/cdev.13708']
2284,34742327,PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial.,"BACKGROUND/AIMS


Despite evidence that preferential use of balanced/buffered fluids may improve outcomes compared with chloride-rich 0.9% saline, saline remains the most commonly used fluid for children with septic shock. We aim to determine if resuscitation with balanced/buffered fluids as part of usual care will improve outcomes, in part through reduced kidney injury and without an increase in adverse effects, compared to 0.9% saline for children with septic shock.
METHODS


The Pragmatic Pediatric Trial of Balanced versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) study is an international, open-label pragmatic interventional trial being conducted at > 40 sites in the USA, Canada, and Australia/New Zealand starting on August 25, 2020, and continuing for 5 years. Children > 6 months to < 18 years treated for suspected septic shock with abnormal perfusion in an emergency department will be randomized to receive either balanced/buffered crystalloids (intervention) or 0.9% saline (control) for initial resuscitation and maintenance fluids for up to 48 h. Eligible patients are enrolled and randomized using serially numbered, opaque envelopes concurrent with clinical care. Given the life-threatening nature of septic shock and narrow therapeutic window to start fluid resuscitation, patients may be enrolled under ""exception from informed consent"" in the USA or ""deferred consent"" in Canada and Australia/New Zealand. Other than fluid type, all decisions about timing, volume, and rate of fluid administration remain at the discretion of the treating clinicians. For pragmatic reasons, clinicians will not be blinded to study fluid type. Anticipated enrollment is 8800 patients. The primary outcome will be major adverse kidney events within 30 days (MAKE30), a composite of death, renal replacement therapy, and persistent kidney dysfunction. Additional effectiveness, safety, and biologic outcomes will also be analyzed.
DISCUSSION


PRoMPT BOLUS will provide high-quality evidence for the comparative effectiveness of buffered/balanced crystalloids versus 0.9% saline for the initial fluid management of children with suspected septic shock in emergency settings.
TRIAL REGISTRATION


PRoMPT BOLUS was first registered at ClinicalTrials.gov ( NCT04102371 ) on September 25, 2019. Enrollment started on August 25, 2020.",2021,"PRoMPT BOLUS will provide high-quality evidence for the comparative effectiveness of buffered/balanced crystalloids versus 0.9% saline for the initial fluid management of children with suspected septic shock in emergency settings.
","['children with septic shock', 'children with suspected septic shock in emergency settings', 'Children >\u20096\u2009months to <\u200918\u2009years treated for suspected septic shock with abnormal perfusion in an emergency department', '\u200940 sites in the USA, Canada, and Australia/New Zealand starting on August 25, 2020, and continuing for 5 years', '8800 patients', 'Sepsis']","['PRoMPT BOLUS', 'Balanced vs nOrmaL Saline FlUid', 'balanced/buffered crystalloids (intervention) or 0.9% saline (control) for initial resuscitation and maintenance fluids', 'Balanced versus Normal Saline Fluid']","['adverse effects', 'major adverse kidney events within 30\u2009days (MAKE30), a composite of death, renal replacement therapy, and persistent kidney dysfunction', 'Additional effectiveness, safety, and biologic outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.597706,"PRoMPT BOLUS will provide high-quality evidence for the comparative effectiveness of buffered/balanced crystalloids versus 0.9% saline for the initial fluid management of children with suspected septic shock in emergency settings.
","[{'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Weiss', 'Affiliation': ""Department of Anesthesiology and Critical Care, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. WeissS@chop.edu.""}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Balamuth', 'Affiliation': ""The Children's Hospital of Philadelphia Pediatric Sepsis Program, Philadelphia, PA, USA.""}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Long', 'Affiliation': ""Department of Emergency Medicine, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Graham C', 'Initials': 'GC', 'LastName': 'Thompson', 'Affiliation': ""Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Hayes', 'Affiliation': ""The Children's Hospital of Philadelphia Pediatric Sepsis Program, Philadelphia, PA, USA.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Katcoff', 'Affiliation': ""Department of Biomedical and Health Informatics, Data Science and Biostatistics Unit, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Marlena', 'Initials': 'M', 'LastName': 'Cook', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tsemberis', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Hickey', 'Affiliation': ""The Children's Hospital of Philadelphia Pediatric Sepsis Program, Philadelphia, PA, USA.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': ""Department of Emergency Medicine, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Williamson-Urquhart', 'Affiliation': ""Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Borland', 'Affiliation': ""Divisions of Emergency Medicine and Pediatrics, Perth Children's Hospital, School of Medicine at the University of Western Australia, Crawley, Australia.""}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Dalziel', 'Affiliation': ""Departments of Surgery and Pediatrics: Child and Youth Health, Starship Children's Hospital, University of Auckland, Auckland, New Zealand.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Gelbart', 'Affiliation': 'Departments of Pediatrics and Critical Care, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': 'Sections of Pediatric Emergency Medicine and Gastroenterology, Departments of Pediatrics and Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Department of Emergency Medicine, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Emergency Medicine and Pediatrics, UC Davis School of medicine and UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-021-05717-4']
2285,34742328,Adding muscle power exercises to a strength training program for people with patellofemoral pain: protocol of a randomized controlled trial.,"BACKGROUND


Strong evidence supports the proximal combined with quadriceps strengthening for patellofemoral pain (PFP) rehabilitation. However, most reported rehabilitation programs do not follow specific exercise prescription recommendations or do not provide adequate details for replication in clinical practice. Furthermore, people with PFP have power deficits in hip and knee muscles and it remains unknown whether the addition of power exercises would result in superior or more consistent outcomes. Therefore, this study is designed to verify whether the benefits of a rehabilitation program addressing proximal and knee muscles comprising power and strength exercises are greater than those of a program consisting of strength exercises only.
METHOD


This study will be a randomized controlled trial that will be conducted at university facilities. A minimum of 74 people with PFP between the ages of 18 and 45 years will be included. The experimental group will engage in a 12-week resistance training program focusing on proximal and knee muscles using power and strength exercises. The control group will engage in a 12-week resistance training program focusing on proximal and knee muscles using strength exercises only. Primary outcomes will be pain intensity and physical function; and secondary outcomes will be kinesiophobia, self-reported improvement, quality of life, peak hip and knee torque, and hip and knee rate of force development. The primary outcomes will be evaluated at baseline, and after 6 weeks, 12 weeks, 3 months, 6 months, and 1 year. The secondary outcomes will be evaluated at baseline and immediately after the interventions. Therapists and participants will not be blinded to group allocation.
DISCUSSION


This randomized clinical trial will investigate if adding power exercises to a progressive resistance training may lead to more consistent outcomes for PFP rehabilitation. The study will provide additional knowledge to support rehabilitation programs for people with PFP.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03985254. Registered on 26 August 2019.",2021,This randomized clinical trial will investigate if adding power exercises to a progressive resistance training may lead to more consistent outcomes for PFP rehabilitation.,"['people with patellofemoral pain', '74 people with PFP between the ages of 18 and 45\u2009years', 'people with PFP']","['proximal combined with quadriceps strengthening', 'resistance training program focusing on proximal and knee muscles using strength exercises only', 'resistance training program focusing on proximal and knee muscles using power and strength exercises', 'power exercises to a progressive resistance training', 'rehabilitation program addressing proximal and knee muscles comprising power and strength exercises', 'muscle power exercises to a strength training program']","['pain intensity and physical function; and secondary outcomes will be kinesiophobia, self-reported improvement, quality of life, peak hip and knee torque, and hip and knee rate of force development']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",,0.0491365,This randomized clinical trial will investigate if adding power exercises to a progressive resistance training may lead to more consistent outcomes for PFP rehabilitation.,"[{'ForeName': 'Gabriela Souza', 'Initials': 'GS', 'LastName': 'de Vasconcelos', 'Affiliation': 'Physical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil. vasconcelosgs@gmail.com.'}, {'ForeName': 'Guilherme Silva', 'Initials': 'GS', 'LastName': 'Nunes', 'Affiliation': 'Physiotherapy and Rehabilitation Department, Federal University of Santa Maria (UFSM), Av Roraima 1000, Santa Maria, Rio Grande do Sul, CEP 97105-900, Brazil.'}, {'ForeName': 'Christian John', 'Initials': 'CJ', 'LastName': 'Barton', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Raquel Fantinelli', 'Initials': 'RF', 'LastName': 'Munhoz', 'Affiliation': 'Physical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil.'}, {'ForeName': 'Maria Eduarda Chinotti Batista', 'Initials': 'MECB', 'LastName': 'da Silva', 'Affiliation': 'Physical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil.'}, {'ForeName': 'Giulia Keppe', 'Initials': 'GK', 'LastName': 'Pisani', 'Affiliation': 'Physical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil.'}, {'ForeName': 'Bruna Calazans', 'Initials': 'BC', 'LastName': 'Luz', 'Affiliation': 'Physical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil.'}, {'ForeName': 'Fábio Viadanna', 'Initials': 'FV', 'LastName': 'Serrão', 'Affiliation': 'Physical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil.'}]",Trials,['10.1186/s13063-021-05748-x']
2286,34742325,"Protocol for GET FIT Prostate: a randomized, controlled trial of group exercise training for fall prevention and functional improvements during and after treatment for prostate cancer.","BACKGROUND


Many prostate cancer survivors are treated with androgen deprivation therapy (ADT), but these therapies may increase frailty, worsen physical functioning, and increase fall risk. While exercise may counter functional declines associated with ADT, no studies have tested whether and which type of exercise may reduce falls and frailty. The purpose of this trial is to compare the relative efficacy of strength training versus tai ji quan training against each other and to a stretching control group on falls, frailty, and physical functioning in men expose to ADT for prostate cancer.
METHODS


Prostate cancer survivors treated with ADT (N = 360) who have fallen in the past year or are at risk of a fall based on validated risk factors will be recruited to participate in this single-blind, parallel group, randomized trial. Participants will be randomized to one of three supervised, group training programs: (i) strength training, (ii) tai ji quan training, or (iii) stretching (control), that train 3×/week for 6 months. Outcomes are assessed at baseline, 3 (mid-intervention), 6 (immediately post-intervention), and 12 (follow-up) months. The primary outcome is falls assessed by monthly self-report. Secondary outcomes include the following: frailty (low lean body mass (by bioelectrical impedance analysis), exhaustion (by SF-36 vitality scale), low activity (by CHAMPS physical activity survey), slowness (by 4 m usual walk speed), and weakness (by chair stand time)); objective and subjective measures of physical function will also be collected. Negative binomial regression models will be used to assess differences in falls between groups, while mixed effects modeling will be used to compare the relative efficacy of training group on secondary outcomes.
DISCUSSION


Exercise represents a non-pharmacologic approach to mitigate the problem of falls experienced among men treated with ADT. By engaging in appropriate exercise, men may be able to avoid or delay falls, frailty, and disability associated with their cancer treatment. Findings of the trial are expected to inform clinical practice about how exercise could be prescribed as part of cancer care for prostate cancer survivors prescribed ADT.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03741335 . Registered on November 18, 2018.",2021,"The purpose of this trial is to compare the relative efficacy of strength training versus tai ji quan training against each other and to a stretching control group on falls, frailty, and physical functioning in men expose to ADT for prostate cancer.
","['prostate cancer survivors', 'Prostate cancer survivors treated with ADT (N = 360) who have fallen in the past year or are at risk of a fall based on validated risk factors', 'men treated with ADT', 'prostate cancer', 'men expose to ADT for prostate cancer']","['group exercise training', 'group training programs: (i) strength training, (ii) tai ji quan training, or (iii) stretching (control), that train 3×/week for 6\u2009months', 'strength training versus tai ji quan training', 'androgen deprivation therapy (ADT']","['frailty (low lean body mass (by bioelectrical impedance analysis), exhaustion (by SF-36 vitality scale), low activity (by CHAMPS physical activity survey), slowness (by 4\u2009m usual walk speed), and weakness (by chair stand time)); objective and subjective measures of physical function', 'falls assessed by monthly self-report', 'falls, frailty, and physical functioning']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.031429,"The purpose of this trial is to compare the relative efficacy of strength training versus tai ji quan training against each other and to a stretching control group on falls, frailty, and physical functioning in men expose to ADT for prostate cancer.
","[{'ForeName': 'Kerri M', 'Initials': 'KM', 'LastName': 'Winters-Stone', 'Affiliation': 'Knight Cancer Institute, School of Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, USA. wintersk@ohsu.edu.'}, {'ForeName': 'Fuzhong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Oregon Research Institute, Eugene, OR, USA.'}, {'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Horak', 'Affiliation': 'Department of Neurology, School of Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Dieckmann', 'Affiliation': 'School of Nursing, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Hung', 'Affiliation': 'Knight Cancer Institute, School of Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Amling', 'Affiliation': 'Knight Cancer Institute, School of Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, USA.'}, {'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Beer', 'Affiliation': 'Knight Cancer Institute, School of Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, USA.'}]",Trials,['10.1186/s13063-021-05687-7']
2287,34742318,Rice bran oil could favorably ameliorate atherogenicity and insulin resistance indices among men with coronary artery disease: post hoc analysis of a randomized controlled trial.,"BACKGROUND


Despite recent advances in recognizing more reliable indicators to estimate the coronary artery disease (CAD) patients' response to treatment and prognosis, less attention has been paid to evaluating them in clinical trials. Hence, the present research was conducted to study the impact of rice bran oil (RBO) versus sunflower oil (SFO) on various atherogenicity and insulin resistance markers.
METHODS


In the present 8-week randomized controlled trial, 40 CAD men with an average age of 56 years were allocated randomly into the intervention or control group to use RBO or SFO (30 g/day) plus a standardized dietary plan. As a further analysis, eight atherosclerosis-related indices were calculated before and after the study.
RESULTS


Analysis of covariance test in which potential confounders and baseline levels were considered, indicated that using RBO compared to SFO reduced Castelli's risk index I and II (adjusted means:3.29, 1.52 vs. 4.61, 2.20, respectively), atherogenic coefficient (2.29 vs. 3.61), lipoprotein combine index (6.54 vs. 17.53), and cholesterol index (0.46 vs. 1.20) after the trial (P-value ≤ 0.002). Also, the RBO group yielded significantly lower triglyceride glucose index (8.73 vs. 9.13) (P-value = 0.010). Further, marginally significant amelioration in triglyceride/HDL ratio and atherogenic index of plasma (1.48 and 0.13 vs. 1.86 and 0.24 respectively) were noted (P-value = 0.07). Spearman correlation analysis detected significant positive correlations between alterations in TNF-α serum levels (ng/L) and the majority of evaluated indices (P-value < 0.05).
CONCLUSION


Taken together, incorporating 30 g of RBO into the patient's usual diet appeared effective in ameliorating atherogenicity and insulin resistance indicators among men with CAD, probably in relation to its anti-inflammatory properties.
TRIAL REGISTRATION


The protocol of the current trial was retrospectively recorded in the Iranian clinical trial registration system (IRCT) with the registration number of IRCT20190313043045N1 (URL: https://en.irct.ir/trial/38346 ; Registration date: 2019-04-27).",2021,"Further, marginally significant amelioration in triglyceride/HDL ratio and atherogenic index of plasma (1.48 and 0.13 vs. 1.86 and 0.24 respectively) were noted (P-value = 0.07).","['men with CAD', 'men with coronary artery disease', '40 CAD men with an average age of 56\u2009years']","['intervention or control group to use RBO or SFO (30\u2009g/day) plus a standardized dietary plan', 'rice bran oil (RBO) versus sunflower oil (SFO', 'Rice bran oil']","['atherogenic coefficient', 'ameliorating atherogenicity and insulin resistance indicators', 'TNF-α serum levels', 'atherogenicity and insulin resistance indices', 'lipoprotein combine index', 'cholesterol index', 'triglyceride glucose index', ""SFO reduced Castelli's risk index"", 'triglyceride/HDL ratio and atherogenic index of plasma']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0073354', 'cui_str': 'rice bran oil'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",40.0,0.234949,"Further, marginally significant amelioration in triglyceride/HDL ratio and atherogenic index of plasma (1.48 and 0.13 vs. 1.86 and 0.24 respectively) were noted (P-value = 0.07).","[{'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mahdavi-Roshan', 'Affiliation': 'Cardiovascular Diseases Research Center, Department of Cardiology, Heshmat Hospital, School of Medicine, Guilan University of Medical Sciences, 15 Khordad Street, District 2, Rasht, Guilan Province, Iran.'}, {'ForeName': 'Arsalan', 'Initials': 'A', 'LastName': 'Salari', 'Affiliation': 'Cardiovascular Diseases Research Center, Department of Cardiology, Heshmat Hospital, School of Medicine, Guilan University of Medical Sciences, 15 Khordad Street, District 2, Rasht, Guilan Province, Iran.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Vakilpour', 'Affiliation': 'Cardiovascular Diseases Research Center, Department of Cardiology, Heshmat Hospital, School of Medicine, Guilan University of Medical Sciences, 15 Khordad Street, District 2, Rasht, Guilan Province, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Savar Rakhsh', 'Affiliation': 'Cardiovascular Diseases Research Center, Department of Cardiology, Heshmat Hospital, School of Medicine, Guilan University of Medical Sciences, 15 Khordad Street, District 2, Rasht, Guilan Province, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Ghorbani', 'Affiliation': 'Cardiovascular Diseases Research Center, Department of Cardiology, Heshmat Hospital, School of Medicine, Guilan University of Medical Sciences, 15 Khordad Street, District 2, Rasht, Guilan Province, Iran. z.ghorbani.h@gmail.com.'}]",Lipids in health and disease,['10.1186/s12944-021-01584-9']
2288,34742317,Positive effect of combined exercise on adipokines levels and pubertal signs in overweight and obese girls with central precocious puberty.,"BACKGROUND


The prevalence of precocious puberty is increasing. Obesity has been demonstrated to be associated with changes in the adipokine profile and incidence of early puberty in girls. This study assessed the pubertal signs, the levels of adiponectin, resistin, and tumor necrosis factor-alpha (TNF-α) after 12 weeks of combined exercise and 4 weeks of detraining in overweight and obese girls with precocious puberty.
METHODS


Thirty overweight and obese girls (aged 7-9) with precocious puberty, who had received Triptorelin, were randomly divided into two groups (15 exercise and 15 control). Initially, serum levels of adiponectin, resistin, TNF-α, luteinising hormone (LH), and follicle-stimulating hormone (FSH) and the signs of puberty progression (bone age, uterine length, and ovarian volume) were measured. The exercise group performed 60 min of combined (aerobic and resistance) exercise three times/week for 12 weeks. The control group did not receive any exercise. 48 h after the last training session and after 4 weeks of detraining, all research variables were measured (also in the control group). The statistical method used for data analysis was repeated measures ANOVA.
RESULTS


In the exercise group, adiponectin significantly increased and resistin significantly decreased after 12 weeks. After 4 weeks of detraining, adiponectin significantly decreased, but resistin significantly increased. TNF-α levels did not change significantly during the study. There was no significant difference in all of the factors in the control group. Throughout the 16-week study period, the rate of puberty and LH significantly decreased in both exercise and control groups, but FSH, LH/FSH and ovarian volume significantly decreased in the exercise group alone (P<0.05).
CONCLUSIONS


Combined exercise increased adiponectin and decreased resistin and the rate of puberty. However, after 4 weeks of detraining, these effects diminished but did not disappear.
TRIAL REGISTRATION


IRCT, IRCT56471. Registered 25 may 2021 - Retrospectively registered, https://fa.irct.ir/user/profile.",2021,"Throughout the 16-week study period, the rate of puberty and LH significantly decreased in both exercise and control groups, but FSH, LH/FSH and ovarian volume significantly decreased in the exercise group alone (P<0.05).
","['overweight and obese girls with precocious puberty', 'overweight and obese girls with central precocious puberty', 'Thirty overweight and obese girls (aged 7-9) with precocious puberty, who had received']","['combined exercise and 4\u2009weeks of detraining', 'exercise group performed 60\u2009min of combined (aerobic and resistance) exercise', 'combined exercise', 'Triptorelin', 'control group did not receive any exercise']","['rate of puberty and LH', 'adipokines levels and pubertal signs', 'TNF-α levels', 'resistin', 'levels of adiponectin, resistin, and tumor necrosis factor-alpha (TNF-α', 'adiponectin and decreased resistin and the rate of puberty', 'FSH, LH/FSH and ovarian volume', 'serum levels of adiponectin, resistin, TNF-α, luteinising hormone (LH), and follicle-stimulating hormone (FSH) and the signs of puberty progression (bone age, uterine length, and ovarian volume']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034013', 'cui_str': 'Precocious puberty'}, {'cui': 'C0342543', 'cui_str': 'Central precocious puberty'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0429620', 'cui_str': 'Bone age'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",30.0,0.0133446,"Throughout the 16-week study period, the rate of puberty and LH significantly decreased in both exercise and control groups, but FSH, LH/FSH and ovarian volume significantly decreased in the exercise group alone (P<0.05).
","[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Shokri', 'Affiliation': 'Bu Ali Sina University, Faculty of Sport Sciences, Hamedan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Heidarianpour', 'Affiliation': 'Bu Ali Sina University, Faculty of Sport Sciences, Hamedan, Iran. heidarian317@gmail.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Razavi', 'Affiliation': 'Pediatric Endocrinology and Metabolism, Hamedan University of Medical Sciences, Hamedan, Iran.'}]",Lipids in health and disease,['10.1186/s12944-021-01588-5']
2289,34742303,"Improving nurses' knowledge, attitude, and performance in relation to ethical codes through group reflection strategy.","BACKGROUND


The most basic responsibility of nurses that even precedes their therapeutic role is respect for professional ethics in providing clinical care. The present study was conducted to determine the effect of group reflection on the knowledge, attitude and performance of nurses in relation to ethical codes.
METHODS


The present blinded, before-after, educational trial was conducted on 86 nurses working at a general hospital in the south of Iran who were randomly divided into a intervention (n = 44) and a control (n = 42) group. Data were collected before and after the intervention using three tools, including a knowledge test, an attitude rating scale and a performance questionnaire. In the intervention group, the intervention given consisted of four sessions of group reflection, and the control group received a single lecture on ethical codes.
RESULTS


The mean changes in the nurses' score of knowledge after the intervention compared to before differed significantly in both intervention and control groups (P < 0.001), but there was no significant difference between the two groups in terms of the mean changes in the score of knowledge (2.73 ± 3.45 in intervention group vs. 2.57 ± 3.36 in control group, P = 0.83). Although the mean score of attitude differed significantly between the intervention and control groups in the posttest (34.7 ± 8.44 in intervention group vs. 29.95 ± 9.09 in control group, P < 0.014), the two groups were not significantly different in terms of the mean changes in the score of attitude in relation to ethical codes before and after the intervention (P < 0.14). Moreover, the two groups were significantly different in terms of the mean changes in the scores of performance in the two stages (9.07 ± 16.84 in intervention group vs. 0.67 ± 20.01 in control group, P < 0.001).
CONCLUSION


Group reflection can improve the knowledge, attitude and performance of nurses in relation to ethical codes. Although lectures can help improve nurses' knowledge and attitude in this area, they have no significant effects on their performance.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials (No: IRCT2016070317546N6, registration date: 10 October 2016), https://www.irct.ir/trial/16112.",2021,"The mean changes in the nurses' score of knowledge after the intervention compared to before differed significantly in both intervention and control groups (P < 0.001), but there was no significant difference between the two groups in terms of the mean changes in the score of knowledge (2.73 ± 3.45 in intervention group vs. 2.57 ± 3.36 in control group, P = 0.83).",['86 nurses working at a general hospital in the south of Iran who'],['single lecture on ethical codes'],"['knowledge, attitude and performance of nurses', 'attitude rating scale and a performance questionnaire', 'score of knowledge', 'score of attitude in relation to ethical codes', 'mean score of attitude']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C1135938', 'cui_str': 'Code of Ethics'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1135938', 'cui_str': 'Code of Ethics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",86.0,0.0227287,"The mean changes in the nurses' score of knowledge after the intervention compared to before differed significantly in both intervention and control groups (P < 0.001), but there was no significant difference between the two groups in terms of the mean changes in the score of knowledge (2.73 ± 3.45 in intervention group vs. 2.57 ± 3.36 in control group, P = 0.83).","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Momennasab', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Ghanbari', 'Affiliation': 'School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Rivaz', 'Affiliation': 'Community Based Psychiatric Care Research Center, Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Zand St., Namazee Sq, Shiraz, 7193613119, Iran. mrivaz@sums.ac.ir.'}]",BMC nursing,['10.1186/s12912-021-00749-2']
2290,34742297,Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial.,"BACKGROUND


Induction of long-term synaptic depression (LTD) is proposed as a treatment mechanism for chronic pain but remains untested in clinical populations. Two interlinked studies; (1) A patient-assessor blinded, randomised, sham-controlled clinical trial and (2) an open-label mechanistic study, sought to examine therapeutic LTD for persons with chronic peripheral nerve injury pain.
METHODS


(1) Patients were randomised using a concealed, computer-generated schedule to either active or sham non-invasive low-frequency nerve stimulation (LFS), for 3 months (minimum 10 min/day). The primary outcome was average pain intensity (0-10 Likert scale) recorded over 1 week, at 3 months, compared between study groups. (2) On trial completion, consenting subjects entered a mechanistic study assessing somatosensory changes in response to LFS.
RESULTS


(1) 76 patients were randomised (38 per group), with 65 (31 active, 34 sham) included in the intention to treat analysis. The primary outcome was not significant, pain scores were 0.3 units lower in active group (95% CI - 1.0, 0.3; p = 0.30) giving an effect size of 0.19 (Cohen's D). Two non-device related serious adverse events were reported. (2) In the mechanistic study (n = 19) primary outcomes of mechanical pain sensitivity (p = 0.006) and dynamic mechanical allodynia (p = 0.043) significantly improved indicating reduced mechanical hyperalgesia.
CONCLUSIONS


Results from the RCT failed to reach significance. Results from the mechanistic study provide new evidence for effective induction of LTD in a clinical population. Taken together results add to mechanistic understanding of LTD and help inform future study design and approaches to treatment. Trial registration ISRCTN53432663.",2021,"In the mechanistic study (n = 19) primary outcomes of mechanical pain sensitivity (p = 0.006) and dynamic mechanical allodynia (p = 0.043) significantly improved indicating reduced mechanical hyperalgesia.
","['peripheral neuropathic pain', 'persons with chronic peripheral nerve injury pain', '1) Patients']","['Mechanistically informed non-invasive peripheral nerve stimulation', 'concealed, computer-generated schedule to either active or sham non-invasive low-frequency nerve stimulation (LFS']","['mechanical pain sensitivity', 'dynamic mechanical allodynia', 'average pain intensity', 'pain scores', 'mechanical hyperalgesia', 'serious adverse events']","[{'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0262593', 'cui_str': 'Injury of peripheral nerve'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}]","[{'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C2936719', 'cui_str': 'Allodynia, Mechanical'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.758375,"In the mechanistic study (n = 19) primary outcomes of mechanical pain sensitivity (p = 0.006) and dynamic mechanical allodynia (p = 0.043) significantly improved indicating reduced mechanical hyperalgesia.
","[{'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'The Pain Management Programme, Walton Centre NHS Foundation Trust, Lower Lane, Liverpool, L9 7LJ, UK. Selina.johnson@thewaltoncentre.nhs.uk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Pain Research Institute, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Dyfrig', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation (CHEME) Department, Bangor University, Bangor, Wales, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Holmes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation (CHEME) Department, Bangor University, Bangor, Wales, UK.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Henrich', 'Affiliation': 'Department of Neurophysiology, Mannheim Centre for Translational Neurosciences, Medical Faculty Mannheim, Ruprecht Karls-University Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Turo', 'Initials': 'T', 'LastName': 'Nurmikko', 'Affiliation': 'The Pain Management Programme, Walton Centre NHS Foundation Trust, Lower Lane, Liverpool, L9 7LJ, UK.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'The Pain Management Programme, Walton Centre NHS Foundation Trust, Lower Lane, Liverpool, L9 7LJ, UK.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Frank', 'Affiliation': 'The Pain Management Programme, Walton Centre NHS Foundation Trust, Lower Lane, Liverpool, L9 7LJ, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd, Amersham, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'The Pain Management Programme, Walton Centre NHS Foundation Trust, Lower Lane, Liverpool, L9 7LJ, UK.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Magerl', 'Affiliation': 'Department of Neurophysiology, Mannheim Centre for Translational Neurosciences, Medical Faculty Mannheim, Ruprecht Karls-University Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goebel', 'Affiliation': 'The Pain Management Programme, Walton Centre NHS Foundation Trust, Lower Lane, Liverpool, L9 7LJ, UK.'}]",Journal of translational medicine,['10.1186/s12967-021-03128-2']
2291,34742284,"Project SUMS (scaling up of mental health in schools): design and methods for a pragmatic, cluster randomised waitlist-controlled trial on integrated school mental health intervention for adolescents.","BACKGROUND


There is an increasing need for Mental Health Promotion (MHP) among adolescents, especially in developing countries with limited resources and rapid socio-demographic transition. With the growing burden of mental health problems among adolescents (suicide, depression) and their preferences to seek help from their peers, improving Mental Health Literacy (MHL) and behaviours for First Aid in Mental Health (MH-FA) becomes crucial to promote their mental health.
METHODS


Schools are ideal settings for reaching the vulnerable adolescents. The proposed study evaluates the effectiveness of a classroom-based teacher-led integrated school mental health intervention called SUMS (MHP + MHL + MH-FA). The study will involve a pragmatic, cluster-randomised waitlist-controlled design to evaluate the effectiveness of SUMS intervention using schools as unit-of-randomisation. The study will be conducted in Srinivaspura taluka (Sub-district) of Kolar district (administrative unit of health) of Karnataka in collaboration with a multi-disciplinary expert team from NIMHANS (National Institute of Mental Health And Neuro Sciences), Bangalore-India and Department of Education, Government of Karnataka, India. A total of 8 schools (400 students studying in 6-8 grade) from Srinivaspura taluka will be randomised into intervention and waitlist control group. The intervention group will receive SUMS intervention through 10-15 h of classroom sessions. The primary outcome is the improvement in positive mental health literacy, as measured by the Mental Health-Promoting Knowledge (MHPK-10) scale. Changes in MH-FA knowledge and intentions, Mental health stigma, help-seeking and resilience are assessed as secondary outcomes. Data will be collected at baseline, 6-weeks, 6-months and 12-months post-intervention. The waitlist-control schools will receive the interventions at the end of the 12-month follow-up assessment in intervention-schools.
DISCUSSION


This is the first study to integrate Mental Health Literacy with Mental Health Promotion and behaviours for First Aid in Mental Health to promote mental health well-being among adolescent school children in India. With a need to build a more substantial evidence base on School Mental Health Promotion approaches in developing countries, the study findings will have implications for implementing and operationalising Health and Wellness Ambassador initiative in India.
TRIAL REGISTRATION


Clinical Trials Registry - India, CTRI/2019/07/020394. Registered prospectively on 29 July 2019. ( ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=35724&EncHid=&userName=sums ).",2021,The proposed study evaluates the effectiveness of a classroom-based teacher-led integrated school mental health intervention called SUMS (MHP + MHL + MH-FA).,"['Srinivaspura taluka (Sub-district) of Kolar district (administrative unit of health) of Karnataka in collaboration with a multi-disciplinary expert team from NIMHANS (National Institute of Mental Health And Neuro Sciences), Bangalore-India and Department of Education, Government of Karnataka, India', 'adolescent school children in India', 'adolescents', 'A total of 8 schools (400 students studying in 6-8 grade) from Srinivaspura taluka', 'Schools are ideal settings for reaching the vulnerable adolescents', 'adolescents (suicide, depression']","['classroom-based teacher-led integrated school mental health intervention called SUMS (MHP\u2009+\u2009MHL\u2009+\u2009MH-FA', 'SUMS intervention', 'SUMS intervention through 10-15\u2009h of classroom sessions', 'integrated school mental health intervention']","['Mental Health Literacy (MHL) and behaviours', 'MH-FA knowledge and intentions, Mental health stigma, help-seeking and resilience', 'improvement in positive mental health literacy, as measured by the Mental Health-Promoting Knowledge (MHPK-10) scale']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0027466', 'cui_str': 'National Institute of Mental Health'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.101293,The proposed study evaluates the effectiveness of a classroom-based teacher-led integrated school mental health intervention called SUMS (MHP + MHL + MH-FA).,"[{'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Amudhan', 'Affiliation': 'Department of Epidemiology, National Institute of Mental Health And Neuro Sciences, Bangalore, Karnataka, India. sam_mmc1999@yahoo.co.in.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Jangam', 'Affiliation': 'Department of Psychiatric Social Work, National Institute of Mental Health And Neuro Sciences, Bangalore, Karnataka, India.'}, {'ForeName': 'Kalaivani', 'Initials': 'K', 'LastName': 'Mani', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, Delhi, India.'}, {'ForeName': 'Nithya Poornima', 'Initials': 'NP', 'LastName': 'Murugappan', 'Affiliation': 'Clinical Psychologist, Independent Consultant, Bangalore, Karnataka, India.'}, {'ForeName': 'Eesha', 'Initials': 'E', 'LastName': 'Sharma', 'Affiliation': 'Department of Child and Adolescent Psychiatry, National Institute of Mental Health And Neuro Sciences, Bangalore, Karnataka, India.'}, {'ForeName': 'Payel', 'Initials': 'P', 'LastName': 'Mahapatra', 'Affiliation': 'Department of Epidemiology, National Institute of Mental Health And Neuro Sciences, Bangalore, Karnataka, India.'}, {'ForeName': 'Ajit Deo', 'Initials': 'AD', 'LastName': 'Burma', 'Affiliation': 'Department of Epidemiology, National Institute of Mental Health And Neuro Sciences, Bangalore, Karnataka, India.'}, {'ForeName': 'Hemant Kumar', 'Initials': 'HK', 'LastName': 'Tiwari', 'Affiliation': 'Department of Epidemiology, National Institute of Mental Health And Neuro Sciences, Bangalore, Karnataka, India.'}, {'ForeName': 'Ashi', 'Initials': 'A', 'LastName': 'Ashok', 'Affiliation': 'Department of Epidemiology, National Institute of Mental Health And Neuro Sciences, Bangalore, Karnataka, India.'}, {'ForeName': 'Sangappa', 'Initials': 'S', 'LastName': 'Vaggar', 'Affiliation': 'Department of Epidemiology, National Institute of Mental Health And Neuro Sciences, Bangalore, Karnataka, India.'}, {'ForeName': 'Girish Nagaraja', 'Initials': 'GN', 'LastName': 'Rao', 'Affiliation': 'Department of Epidemiology, National Institute of Mental Health And Neuro Sciences, Bangalore, Karnataka, India.'}]",BMC public health,['10.1186/s12889-021-12086-9']
2292,34742270,POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial.,"BACKGROUND


Various randomized trials have demonstrated that postmastectomy radiotherapy (RT) to the chest wall and comprehensive regional nodal areas improves survival in patients with axillary node-positive breast cancer. Controversy exists as to whether the internal mammary node (IMN) region is an essential component of regional nodal irradiation. Available data on the survival benefit of IMN irradiation (IMNI) are conflicting. The patient populations enrolled in previous studies were heterogeneous and most studies were conducted before modern systemic treatment and three-dimensional (3D) radiotherapy (RT) techniques were introduced. This study aims to assess the efficacy and safety of IMNI in the context of modern systemic treatment and computed tomography (CT)-based RT planning techniques.
METHODS


POTENTIAL is a prospective, multicenter, open-label, parallel, phase III, randomized controlled trial investigating whether IMNI improves disease-free survival (DFS) in high-risk breast cancer with positive axillary nodes (pN+) after mastectomy. A total of 1800 patients will be randomly assigned in a 1:1 ratio to receive IMNI or not. All patients are required to receive ≥ six cycles of anthracycline and/or taxane-based chemotherapy. Randomization will be stratified by institution, tumor location (medial/central vs. other quadrants), the number of positive axillary nodes (1-3 vs. 4-9 vs. ≥10), and neoadjuvant chemotherapy (yes vs. no). Treatment will be delivered with CT-based 3D RT techniques, including 3D conformal RT, intensity-modulated RT, or volumetric modulated arc therapy. The prescribed dose is 50 Gy in 25 fractions or 43.5 Gy in 15 fractions. Tiered RT quality assurance is required. After RT, patients will be followed up at regular intervals. Oncological and toxilogical outcomes, especially cardiac toxicities, will be assessed.
DISCUSSION


This trial design is intended to overcome the limitations of previous prospective studies by recruiting patients with pN+ breast cancer, using DFS as the primary endpoint, and prospectively assessing cardiac toxicities and requiring RT quality assurance. The results of this study will provide high-level evidence for elective IMNI in patients with breast cancer after mastectomy.
TRIAL REGISTRATION


ClinicalTrails.gov , NCT04320979 . Registered 25 Match 2020, https://clinicaltrials.gov/ct2/show/NCT04320979.",2021,"Treatment will be delivered with CT-based 3D RT techniques, including 3D conformal RT, intensity-modulated RT, or volumetric modulated arc therapy.","['patients with axillary node-positive breast cancer', 'Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation', 'patients with pN+ breast cancer', '1800 patients', 'high-risk breast cancer with positive axillary nodes (pN+) after mastectomy', 'patients with breast cancer after mastectomy']","['postmastectomy radiotherapy (RT', 'CT-based 3D RT techniques, including 3D conformal RT, intensity-modulated RT, or volumetric modulated arc therapy', 'modern systemic treatment and three-dimensional (3D) radiotherapy (RT) techniques', 'POstmastectomy radioThErapy', 'computed tomography (CT)-based RT planning techniques', 'anthracycline and/or taxane-based chemotherapy', 'IMNI', 'IMN irradiation (IMNI']","['cardiac toxicities and requiring RT quality assurance', 'Oncological and toxilogical outcomes, especially cardiac toxicities', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0454111', 'cui_str': 'Radiotherapy planning'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0022132', 'cui_str': 'Isle of Man'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0447180', 'cui_str': 'Internal mammary node'}]","[{'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",1800.0,0.255476,"Treatment will be delivered with CT-based 3D RT techniques, including 3D conformal RT, intensity-modulated RT, or volumetric modulated arc therapy.","[{'ForeName': 'Xu-Ran', 'Initials': 'XR', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Zhi-Hui', 'Initials': 'ZH', 'LastName': 'Hu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Jing', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Heart Failure Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Xue-Na', 'Initials': 'XN', 'LastName': 'Yan', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Yong-Wen', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Shu-Nan', 'Initials': 'SN', 'LastName': 'Qi', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Ning-Ning', 'Initials': 'NN', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Kuo', 'Initials': 'K', 'LastName': 'Men', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. menkuo126@126.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21205-2013, USA. huc@jhu.edu.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': 'Heart Failure Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, 100037, China. yuhuizhangjoy@163.com.'}, {'ForeName': 'Ye-Xiong', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. yexiong12@163.com.'}, {'ForeName': 'Shu-Lian', 'Initials': 'SL', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. wsl20040118@yahoo.com.'}]",BMC cancer,['10.1186/s12885-021-08852-y']
2293,34742266,Improving preoperative breast reconstruction consultations: a qualitative study on the impact of personalised audio-recordings.,"BACKGROUND


To investigate the value of audio-recordings in aiding patient understanding and recall of preoperative breast reconstruction information.
METHODS


This was a prospective cohort study. Participants were randomly allocated into either a recording group who were offered the opportunity to record their breast reconstruction explanation of surgery, or a standard information package group who received standard care. The value of having an audio-recording was assessed by semi-structured interviews and analysis of recurring themes.
RESULTS


Between 21/2/19 and 19/3/20, 32 women attending consultations for breast reconstruction consented to participate in the study, 17 were randomly assigned to the recording group and 15 the standard information package group. Twenty-eight of the 32 participants completed qualitative interviews. All participants agreed that audio-recordings were a beneficial resource which allowed them to have a better understanding of the concepts discussed. Commonly reported themes included the ability to listen to the recording multiple times to refresh memory, as well as usefulness in helping to inform other family members. Participants also reported increased levels of trust in their clinician for allowing the audio-recordings. Very few participants raised any medico-legal implications of the recordings, their focus was more on the potential of the audio-recordings to alleviate the overwhelming nature of a pre-operative breast reconstruction consultation.
CONCLUSIONS


There was a positive response from participants to the use of audio-recordings in the setting of breast reconstruction consultations. These types of recordings could potentially be used in other complex appointments where detailed information is discussed, with similar success.",2021,All participants agreed that audio-recordings were a beneficial resource which allowed them to have a better understanding of the concepts discussed.,"['32 women attending consultations for breast reconstruction consented to participate in the study, 17', 'Twenty-eight of the 32 participants completed qualitative interviews']","['standard information package group', 'personalised audio-recordings', 'recording group who were offered the opportunity to record their breast reconstruction explanation of surgery, or a standard information package group who received standard care']","['value of having an audio-recording', 'levels of trust in their clinician']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]",32.0,0.0388945,All participants agreed that audio-recordings were a beneficial resource which allowed them to have a better understanding of the concepts discussed.,"[{'ForeName': 'Josipa', 'Initials': 'J', 'LastName': 'Petric', 'Affiliation': 'Flinders Medical Centre, Flinders Drive, Bedford Park, SA, 5042, Australia.'}, {'ForeName': 'Bahara', 'Initials': 'B', 'LastName': 'Sadri', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Sturt Road, Bedford Park, SA, 5042, Australia.'}, {'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'van Essen', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Flinders Medical Centre, Flinders Drive, Bedford Park, SA, 5042, Australia. phillipa.vanessen@sa.gov.au.'}, {'ForeName': 'Nicola Ruth', 'Initials': 'NR', 'LastName': 'Dean', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Sturt Road, Bedford Park, SA, 5042, Australia.'}]",BMC women's health,['10.1186/s12905-021-01534-8']
2294,34742233,"""To be seen"" - older adults and their relatives' care experiences given by a geriatric mobile team (GerMoT).","BACKGROUND


The proportion of older people in the population has increased globally and has thus become a challenge in health and social care. There is good evidence that care based on comprehensive geriatric assessment (CGA) is superior to the usual care found in acute hospital settings; however, the evidence is scarcer in community-dwelling older people. This study is a secondary outcome of a randomized controlled trial of community-dwelling older people in which the intervention group (IG) received CGA-based care by a geriatric mobile geriatric team (GerMoT). The aim of this study is to obtain a better understanding, from the patients' perspective, the experience of being a part of the IG for both the participants and their relatives.
METHODS


Qualitative semistructured interviews of twenty-two community dwelling participants and eleven of their relatives were conducted using content analysis for interpretation.
RESULTS


The main finding expressed by the participants and their relatives was in the form of feelings related to safety and security and being recognized. The participants found the care easily accessible, and that contacts could be taken according to needs by health care professionals who knew them. This is in accordance with person-centred care as recommended by the World Health Organisation (WHO) for older people in need of integrated care. Other positive aspects were recurrent health examinations and being given the time needed when seeking health care. Not all participants were positive as some found the information about the intervention to be unclear especially regarding whom to contact when in different situations.
CONCLUSIONS


CGA-based care of community-dwelling older people shows promising results as the participants in GerMoT found the care was giving a feeling of security and safety. They found the care easily accessible and that it was provided by health care professionals who knew them as a person and knew their health care problems. They found this to be in contrast to the usual care provided, but GerMoT care did not fulfill some people's expectations.",2021,"Not all participants were positive as some found the information about the intervention to be unclear especially regarding whom to contact when in different situations.
","['community-dwelling older people', 'Qualitative semistructured interviews of twenty-two community dwelling participants and eleven of their relatives']",['CGA-based care by a geriatric mobile geriatric team (GerMoT'],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]","[{'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}]",[],22.0,0.0414186,"Not all participants were positive as some found the information about the intervention to be unclear especially regarding whom to contact when in different situations.
","[{'ForeName': 'Iréne', 'Initials': 'I', 'LastName': 'Ericsson', 'Affiliation': 'School of Health Sciences, Jönköping University, 553 18, Jönköping, Sweden.'}, {'ForeName': 'Anne W', 'Initials': 'AW', 'LastName': 'Ekdahl', 'Affiliation': 'Department of Clinical Sciences Helsingborg, Helsingborg Hospital, Lund University, Almahuset, Svartbrödregränden 3-5, Fack 2, 252 23, Helsingborg, Sweden. anne_wissendorff.ekdahl@med.lu.se.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Hellström', 'Affiliation': 'The Department of Health Care Sciences, Palliative Research Centre, Ersta Sköndal Bräcke University College, 116 28, Stockholm, Sweden.'}]",BMC geriatrics,['10.1186/s12877-021-02587-y']
2295,34742230,"Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine.","BACKGROUND


Lasmiditan (LTN) is a selective 5-HT 1F  receptor agonist for the acute treatment of migraine in adults. We present detailed safety findings from the placebo-controlled, double-blind Phase 3 study, of LTN treatment across 4 attacks (CENTURION).
METHODS


Patients were randomized 1:1:1 to LTN 200 mg (LTN200), LTN100, or a control group that received placebo for 3 attacks and LTN50 for either the 3rd or 4th attack (1:1). Safety analyses were conducted for patients who took ≥1 dose of study drug and, in some cases, those who took all 4 doses.
RESULTS


Overall, 1471 patients treated 4494 attacks. The incidences of treatment-emergent serious adverse events (SAEs) were - placebo, n=2 (0.4 %); LTN100, n=1 (0.2 %); LTN200, n=2 (0.4 %); no specific treatment-emergent SAE was reported in more than one patient. The most common treatment emergent adverse events (TEAEs) with lasmiditan were dizziness, paresthesia, fatigue, nausea, vertigo, and somnolence; the vast majority were mild or moderate in severity. The incidences of these TEAEs were highest during the first attack and decreased during subsequent attacks. For patients who experienced a common TEAE with the first attack, less than 45 % experienced the same event in subsequent attacks. Patients who did not experience an event in the 1st attack infrequently experienced the same event in subsequent attacks. The time of onset of the common TEAE ranged from ~40 min to 1 h (dependent upon TEAE) and, for individual TEAE, the onset was similar across attacks. Duration was dependent upon TEAE and attack. It was shortest for paresthesia (< 2 h for all attacks); it ranged from 1.8 to 5.5 h for other common TEAEs and was generally similar across attacks. Serotonin syndrome was reported for 2 patients post LTN dosing; there were no meaningful differences across treatment groups in suicidality; there was no evidence of an increase in motor vehicle accidents.
CONCLUSION


In this blinded, controlled, multiple-attack study, LTN was associated with generally mild or moderate CNS-related TEAEs of short duration. TEAEs tended to decrease in frequency across the 4 attacks.
TRIAL REGISTRATION


NCT03670810.",2021,"Serotonin syndrome was reported for 2 patients post LTN dosing; there were no meaningful differences across treatment groups in suicidality; there was no evidence of an increase in motor vehicle accidents.
","['1471 patients treated 4494 attacks', 'Patients']","['LTN', 'LTN 200\xa0mg (LTN200), LTN100, or a control group that received placebo', 'placebo', 'Lasmiditan (LTN']","['dizziness, paresthesia, fatigue, nausea, vertigo, and somnolence', 'incidences of treatment-emergent serious adverse events (SAEs', 'motor vehicle accidents', 'Serotonin syndrome', 'suicidality', 'paresthesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1367973', 'cui_str': 'Automobile accident'}, {'cui': 'C0024586', 'cui_str': 'Carcinoid syndrome'}]",,0.163811,"Serotonin syndrome was reported for 2 patients post LTN dosing; there were no meaningful differences across treatment groups in suicidality; there was no evidence of an increase in motor vehicle accidents.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tassorelli', 'Affiliation': 'University of Pavia, Pavia, Lombardy, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bragg', 'Affiliation': 'Eli Lilly and Company, IN, 46285, Indianapolis, USA. bragg_sonja_m@lilly.com.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': 'Eli Lilly and Company, IN, 46285, Indianapolis, USA.'}, {'ForeName': 'E G', 'Initials': 'EG', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly and Company, IN, 46285, Indianapolis, USA.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Ardayfio', 'Affiliation': 'Eli Lilly and Company, IN, 46285, Indianapolis, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ruff', 'Affiliation': 'Eli Lilly and Company, IN, 46285, Indianapolis, USA.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Dowsett', 'Affiliation': 'Eli Lilly and Company, IN, 46285, Indianapolis, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schwedt', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}]",The journal of headache and pain,['10.1186/s10194-021-01343-2']
2296,34743348,Pharmacokinetics and Safety of Ferric Pyrophosphate Citrate Intravenous: Equivalence to Administration via Dialysate.,"Ferric pyrophosphate citrate (FPC) is indicated to maintain hemoglobin in chronic hemodialysis patients (CKD-5HD) by addition to the dialysate. An intravenous (IV) FPC presentation containing 6.75 mg iron in 4.5 mL was developed. The objective was to establish the equivalence of iron delivery via dialysate and IV infusion using a pharmacokinetic approach. An open-label, randomized, multiple period, single dose, crossover study was conducted in 27 CKD-5HD patients. Each patient received: 1) a basal iron profile over 12 hours; 2) FPC 6.75 mg Fe IV pre-dialyzer (Pre-D); 3) FPC 6.75 mg Fe IV post-dialyzer (Post-D) and 4) FPC 2 μM (110 μg Fe/L of hemodialysate (Fe-HD). Serum and plasma iron was analyzed for total Fe (sFe tot  and pFe tot  ) and Transferrin Bound Iron (TBI). Equivalence was determined by comparing C max  and AUC 0-last  of Fe-HD (reference) and test treatments Fe Pre-D and Post-D iron profiles. The main outcome measure was the measurement of bioequivalence between the reference and test treatments. Bioequivalence parameters showed that infusion of FPC iron IV, pre- and post-dialyzer delivered equivalent iron as via hemodialysate. The increment in sFe from pre-dialysis to post-dialysis was the same as observed in the long-term clinical studies of FPC. FPC IV was well tolerated. Intravenous infusion of 6.75 mg iron as FPC during 3 hours of HD delivers an equivalent amount of iron as when Triferic is delivered via hemodialysate. The intravenous presentation of FPC extends the ability to provide FPC iron to all patients receiving hemodialysis or hemodiafiltration. This article is protected by copyright. All rights reserved.",2021,The increment in sFe from pre-dialysis to post-dialysis was the same as observed in the long-term clinical studies of FPC.,"['patients receiving hemodialysis or hemodiafiltration', 'chronic hemodialysis patients (CKD-5HD', '27 CKD-5HD patients']","['FPC 6.75 mg Fe IV post-dialyzer', 'Ferric pyrophosphate citrate (FPC', 'Ferric Pyrophosphate Citrate Intravenous', 'FPC 6.75 mg Fe IV pre-dialyzer']","['tolerated', 'Serum and plasma iron', 'total Fe (sFe tot  and pFe tot  ) and Transferrin Bound Iron (TBI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0032580', 'cui_str': 'Adenomatous polyposis coli'}, {'cui': 'C4708904', 'cui_str': '6.75'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4018308', 'cui_str': 'ferric pyrophosphate citrate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0858126', 'cui_str': 'Plasma iron'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1870204', 'cui_str': '(18F)1-(2-fluoroethyl)-4-((4-cyanophenoxy)methyl)piperidine'}, {'cui': 'C1852222', 'cui_str': 'Failure of Tooth Eruption, Primary'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}]",27.0,0.0307418,The increment in sFe from pre-dialysis to post-dialysis was the same as observed in the long-term clinical studies of FPC.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Marbury', 'Affiliation': 'Orlando Clinical Research Center, Orlando, FL, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'van Heuveln', 'Affiliation': 'QPS Netherlands BV, Groningen, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'van der Horst', 'Affiliation': 'QPS Netherlands BV, Groningen, The Netherlands.'}, {'ForeName': 'Raymond D', 'Initials': 'RD', 'LastName': 'Pratt', 'Affiliation': 'Rockwell Medical Inc, Wixom, MI, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1997']
2297,34743319,"Acute effects of psilocybin after escitalopram or placebo pretreatment in a randomized, double-blind, placebo-controlled, cross-over study in healthy subjects.","The psychedelic psilocybin is being investigated for the treatment of depression and anxiety. Unclear is whether antidepressant treatments interact with psilocybin. The present study used a double-blind, placebo-controlled, cross-over design with two experimental test sessions to investigate the response to psilocybin (25 mg) in healthy subjects after pretreatment with escitalopram or placebo. The treatment order was random and counterbalanced. Pretreatment consisted of 10 mg escitalopram daily for 7 days, followed by 20 mg daily for 7 days, including the day of psilocybin administration, or 14 days of placebo pretreatment before psilocybin administration. Psilocybin treatments were separated by at least 16 days. The outcome measures included self-rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain-derived neurotrophic factor (BDNF) levels, electrocardiogram QTc time, whole-blood HTR2A and SCL6A4 gene expression, and pharmacokinetics. Escitalopram pretreatment had no relevant effect on positive mood effects of psilocybin but significantly reduced bad drug effects, anxiety, adverse cardiovascular effects, and other adverse effects of psilocybin compared with placebo pretreatment. Escitalopram did not alter the pharmacokinetics of psilocin. The half-life of psychoactive free (unconjugated) psilocin was 1.8 h (range 1.1-2.2 h), consistent with the short duration of action of psilocybin. Escitalopram did not alter HTR2A or SCL6A4 gene expression before psilocybin administration, QTc intervals, or circulating BDNF levels before or after psilocybin administration. Further studies are needed with a longer antidepressant pretreatment time and patients with psychiatric disorders to further define interactions between antidepressants and psilocybin.",2021,"Escitalopram pretreatment had no relevant effect on positive mood effects of psilocybin but significantly reduced bad drug effects, anxiety, adverse cardiovascular effects, and other adverse effects of psilocybin compared with placebo pretreatment.","['patients with psychiatric disorders', 'healthy subjects after pretreatment with', 'healthy subjects']","['Psilocybin', 'placebo', 'psilocybin', 'escitalopram or placebo']","['HTR2A or SCL6A4 gene expression before psilocybin administration, QTc intervals, or circulating BDNF levels', 'bad drug effects, anxiety, adverse cardiovascular effects', 'self-rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain-derived neurotrophic factor (BDNF) levels, electrocardiogram QTc time, whole-blood HTR2A and SCL6A4 gene expression, and pharmacokinetics', 'pharmacokinetics of psilocin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C3179340', 'cui_str': 'Autonomic Effects'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0033848', 'cui_str': 'Psilocin'}]",,0.0711471,"Escitalopram pretreatment had no relevant effect on positive mood effects of psilocybin but significantly reduced bad drug effects, anxiety, adverse cardiovascular effects, and other adverse effects of psilocybin compared with placebo pretreatment.","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Becker', 'Affiliation': 'Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Grandinetti', 'Affiliation': 'Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Klaiber', 'Affiliation': 'Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel.'}, {'ForeName': 'Vanja E', 'Initials': 'VE', 'LastName': 'Toedtli', 'Affiliation': 'Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel.'}, {'ForeName': 'Karolina E', 'Initials': 'KE', 'LastName': 'Kolaczynska', 'Affiliation': 'Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Duthaler', 'Affiliation': 'Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Psychiatric University Hospital, University of Basel.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Psychiatric University Hospital, University of Basel.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Grünblatt', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2487']
2298,34743243,"Management of initial carious lesions of hypomineralized molars (MIH) with silver diamine fluoride or silver-modified atraumatic restorative treatment (SMART): 1-year results of a prospective, randomized clinical trial.","OBJECTIVES


This study evaluated and compared the effect of silver diamine fluoride (SDF) and silver-modified atraumatic restorative treatment (SMART) sealants for the treatment of initial carious lesions of permanent molars affected by molar incisor hypomineralization (MIH).
METHODS


One hundred and twelve hypomineralized permanent molars with ICDAS 1 or 2 lesions were selected in 48 children. The teeth were randomized into SDF and SMART sealant groups (n = 56 teeth/group) in a split-mouth fashion. Hypersensitivity, formation of caries, and enamel breakdown were evaluated in both groups. Hypersensitivity was assessed by Schiff Cold Air Sensitivity Scale (SCASS), and clinical assessments of SMART sealants were performed according to modified USPHS criteria at 1, 6, and 12 months. The data were analyzed statistically using Fisher's exact test, Kaplan-Meier analysis, Mann-Whitney U test, and Friedman test.
RESULTS


Twenty-six hypomineralized molars with marked baseline hypersensitivity showed significantly lower SCASS scores at all evaluation periods (p < 0.001). There was no significant difference in hypersensitivity scores between the groups at the repeated applications of SDF at 1, 6, and 12 months. The cumulative survival rates of SMART sealants on occlusal and palatal surfaces were 88.7% and 58.8%, respectively.
CONCLUSIONS


In hypomineralized molars, both SDF and SMART sealants showed favorable short-term prevention against dental caries while providing effective desensitization. Marginal discoloration was the most common side effect of the SMART sealants as a result of SDF application.
CLINICAL SIGNIFICANCE


Both SDF and SMART sealants showed similar short-term effectiveness as non-aerosol procedures in arresting enamel caries and reducing hypersensitivity in hypomineralized molars.
TRIAL REGISTRATION


Clinical Trials Registration Number: NCT03862014.",2021,"Both SDF and SMART sealants showed similar short-term effectiveness as non-aerosol procedures in arresting enamel caries and reducing hypersensitivity in hypomineralized molars.
","['One hundred and twelve hypomineralized permanent molars with ICDAS 1 or 2 lesions were selected in 48 children', 'initial carious lesions of hypomineralized molars (MIH', 'initial carious lesions of permanent molars affected by molar incisor hypomineralization (MIH']","['silver diamine fluoride or silver-modified atraumatic restorative treatment (SMART', 'SDF and SMART sealants', 'silver diamine fluoride (SDF) and silver-modified atraumatic restorative treatment (SMART) sealants', 'SDF and SMART sealant', 'SMART sealants']","['Schiff Cold Air Sensitivity Scale (SCASS), and clinical assessments of SMART sealants', 'SCASS scores', 'Hypersensitivity, formation of caries, and enamel breakdown', 'occlusal and palatal surfaces', 'cumulative survival rates', 'hypersensitivity scores']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C2350038', 'cui_str': 'Molar incisor hypomineralization'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}]","[{'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0010456', 'cui_str': 'Cumulative Survival Rate'}]",112.0,0.0408518,"Both SDF and SMART sealants showed similar short-term effectiveness as non-aerosol procedures in arresting enamel caries and reducing hypersensitivity in hypomineralized molars.
","[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Ballikaya', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, Turkey.'}, {'ForeName': 'Gizem Erbas', 'Initials': 'GE', 'LastName': 'Ünverdi', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, Turkey.'}, {'ForeName': 'Zafer C', 'Initials': 'ZC', 'LastName': 'Cehreli', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, Turkey. zcehreli@gmail.com.'}]",Clinical oral investigations,['10.1007/s00784-021-04236-5']
2299,34743231,No antidepressant-like acute effects of bright light on emotional information processing in healthy volunteers.,"RATIONALE


Bright light treatment (BLT) is an efficacious antidepressant intervention, but its mechanism of action is not well understood. Antidepressant drugs acutely affect how emotional information is processed, pushing the brain to prioritise positive relative to negative input. Whether BLT could have a similar effect is not known to date.
OBJECTIVE


To test whether BLT acutely influences emotional information processing similar to antidepressant drugs, using an established healthy volunteer assay.
METHODS


Following a double-blind, parallel-group design, 49 healthy volunteers (18-65 years, 26 females) were randomly allocated to 60-min BLT (≥ 10,000 lux) or sham-placebo treatment early in the morning in autumn/winter. Immediately after treatment, emotional information processing was assessed using the Oxford Emotional Test Battery, a validated set of behavioural tasks tapping into emotional information processing in different cognitive domains. Participants also completed questionnaires before and after treatment to assess changes in subjective state.
RESULTS


The BLT group did not show significantly more positively biased emotional information processing compared to the placebo group (p > 0.05 for all measures). After adjustment for pre-treatment scores, there were also no significant post-treatment differences between groups in subjective state (p > 0.05 for all measures).
CONCLUSIONS


BLT did not show immediate effects on emotional information processing in an established healthy volunteer assay. Thus, BLT might exert its clinical effects through a different (cognitive) mechanism than other antidepressant interventions. Future studies should corroborate this finding including clinical populations and more intensive treatment regimes, and control for potential chronobiological effects.",2021,The BLT group did not show significantly more positively biased emotional information processing compared to the placebo group (p > 0.05 for all measures).,"['49 healthy volunteers (18-65 years, 26 females', 'healthy volunteers']","['bright light', 'placebo', '60-min BLT (≥ 10,000 lux) or sham-placebo', 'BLT', 'Bright light treatment (BLT']","['biased emotional information processing', 'subjective state', 'emotional information processing']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1301808', 'cui_str': 'State'}]",49.0,0.0616087,The BLT group did not show significantly more positively biased emotional information processing compared to the placebo group (p > 0.05 for all measures).,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kaltenboeck', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK. alexander.kaltenboeck@meduniwien.ac.at.'}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Ruzickova', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Breunhölder', 'Affiliation': 'School of Mathematics and Maxwell Institute for Mathematical Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Zghoul', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]",Psychopharmacology,['10.1007/s00213-021-06003-6']
2300,34743154,Comparative Blink Analysis in Patients With Established Facial Paralysis Using High-Speed Video Analysis.,"ABSTRACT


This study analyzed the blink characteristics of patients with incomplete and complete facial paralysis. The authors measured and compared the palpebral distance, eyelid movement distance, and the eye-closing ratio of blinks in 55 patients with Bell's palsy or Ramsay Hunt syndrome (Bell & Hunt group) and 14 with complete paralysis (Complete Paralysis group). In the Bell & Hunt group, the palpebral distance (7.94 mm) was smaller on the paralyzed side than on the non-paralyzed side (9.61 mm). The eye-closing ratio and the upper eyelid movement were reduced on the paralyzed side (65.3% versus 93.7%, 4.61 versus 7.97 mm) and in the Complete Paralysis group (25.3% versus 94.7%, 2.10 versus 8.49 mm). In the Bell & Hunt group, movement of the upper eyelid on the paralyzed side was weakened despite palpebral contracture. The Complete Paralysis group exhibited highly reduced movement in both the upper and lower eyelids.",2021,"The eye-closing ratio and the upper eyelid movement were reduced on the paralyzed side (65.3% versus 93.7%, 4.61 versus 7.97 mm) and in the Complete Paralysis group (25.3% versus 94.7%, 2.10 versus 8.49 mm).","['patients with incomplete and complete facial paralysis', 'Patients With Established Facial Paralysis', ""55 patients with Bell's palsy or Ramsay Hunt syndrome (Bell & Hunt group) and 14 with complete paralysis (Complete Paralysis group""]",[],"['eye-closing ratio and the upper eyelid movement', 'palpebral distance', 'palpebral distance, eyelid movement distance, and the eye-closing ratio of blinks']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0017409', 'cui_str': 'Herpes zoster auricularis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}]",[],"[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0423152', 'cui_str': 'Movement of eyelid'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}]",55.0,0.0469078,"The eye-closing ratio and the upper eyelid movement were reduced on the paralyzed side (65.3% versus 93.7%, 4.61 versus 7.97 mm) and in the Complete Paralysis group (25.3% versus 94.7%, 2.10 versus 8.49 mm).","[{'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, The University of Tokyo Department of Plastic and Reconstructive Surgery, Graduate School of Science Research Administration Divisions, Research University Promotion Organization, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Mutsumi', 'Initials': 'M', 'LastName': 'Okazaki', 'Affiliation': ''}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Mori', 'Affiliation': ''}, {'ForeName': 'Takeaki', 'Initials': 'T', 'LastName': 'Hidaka', 'Affiliation': ''}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Tomioka', 'Affiliation': ''}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': ''}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Uemura', 'Affiliation': ''}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Akiyama', 'Affiliation': ''}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000008326']
2301,34743148,Comparing the Effects of Traditional Education and Root-Cause Analysis on Nursing Students' Attitudes About Safety Culture and Knowledge of Safe Medication Administration Practices: An Experimental Study.,"BACKGROUND


Root-cause analysis (RCA) has been used for decades to support a culture of safety in health care institutions. Although RCA has been recommended for inclusion in a nursing curriculum, little research has been conducted on educational strategies or outcomes.
PURPOSE


The study aims were to compare differences in attitudes about safety culture and knowledge of safe medication administration after education about RCA (intervention) versus traditional safe medication administration education (control) and to provide psychometric data for the Safety Attitudes Questionnaire (SAQ) with nursing students.
METHODS


An experimental pretest/posttest study was conducted in 3 schools of nursing (N = 117).
RESULTS


Although there was no significant difference in outcomes between the control and intervention groups, increases in SAQ scores were observed for the intervention group. The Cronbach's α for the SAQ was .93.
CONCLUSIONS


The SAQ is a reliable instrument for measuring safety culture in schools of nursing.",2021,"Although there was no significant difference in outcomes between the control and intervention groups, increases in SAQ scores were observed for the intervention group.",['3 schools of nursing (N = 117'],"['RCA', 'Traditional Education and Root-Cause Analysis', 'RCA (intervention) versus traditional safe medication administration education (control']","['SAQ scores', 'Safety Attitudes Questionnaire (SAQ']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1275526', 'cui_str': 'Medication administration education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",117.0,0.0472141,"Although there was no significant difference in outcomes between the control and intervention groups, increases in SAQ scores were observed for the intervention group.","[{'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Sanborn Miller', 'Affiliation': 'Author Affiliation: Assistant Professor, Mary Black School of Nursing, University of South Carolina Upstate, Spartanburg.'}]",Nurse educator,['10.1097/NNE.0000000000001126']
2302,34743147,Effects of Postactivation Potentiation on Maximal Vertical Jump Performance After a Conditioning Contraction in Upper-Body and Lower-Body Muscle Groups.,"ABSTRACT


Downey, RJ, Deprez, DA, and Chilibeck, PD. Effects of postactivation potentiation on maximal vertical jump performance after a conditioning contraction in upper-body and lower-body muscle groups. J Strength Cond Res XX(X): 000-000, 2021-Postactivation potentiation (PAP) involves preperformance contractions that can condition a muscle to enhance subsequent force generation and power output. Our purpose was to examine the effects of conditioning contractions that are specific or nonspecific to the target performance on PAP. Resistance-trained subjects (14 males and 10 females) performed a 7-second isometric contraction involving back squat, bench press (as conditioning contractions), or a control condition (rest) on different days in random order, before maximal vertical jump performance. The back squat as a conditioning contraction increased maximal vertical jump by 1.1 ± 3.0 cm (p < 0.05); however, the bench press as a conditioning contraction unexpectedly reduced maximal vertical jump performance by 1.4 ± 2.7 cm (p < 0.05). Conditioning contractions used to elicit a PAP response should use muscles that are specific to the performance movement. Contractions that are not biomechanically similar to the performance movement may hinder subsequent performance.",2021,"The back squat as a conditioning contraction increased maximal vertical jump by 1.1 ± 3.0 cm (p < 0.05); however, the bench press as a conditioning contraction unexpectedly reduced maximal vertical jump performance by 1.4 ± 2.7 cm (p < 0.05).","['Resistance-trained subjects (14 males and 10 females', 'upper-body and lower-body muscle groups', 'Upper-Body and Lower-Body Muscle Groups']","['postactivation potentiation', '7-second isometric contraction involving back squat, bench press (as conditioning contractions), or a control condition (rest', 'J Strength Cond Res XX(X', 'Postactivation Potentiation']","['Maximal Vertical Jump Performance', 'maximal vertical jump performance', '2021-Postactivation potentiation (PAP', 'maximal vertical jump']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}]",14.0,0.0194146,"The back squat as a conditioning contraction increased maximal vertical jump by 1.1 ± 3.0 cm (p < 0.05); however, the bench press as a conditioning contraction unexpectedly reduced maximal vertical jump performance by 1.4 ± 2.7 cm (p < 0.05).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Downey', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Dalton A', 'Initials': 'DA', 'LastName': 'Deprez', 'Affiliation': ''}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000004171']
2303,34743136,"Comparison of Landmark-guided, Nerve Stimulation-guided, and Ultrasound-guided Techniques for Paediatric Caudal Epidural Anaesthesia: A Prospective Randomized Controlled Trial.","OBJECTIVES


Traditionally caudal epidurals are performed by landmark guided approach using the loss of resistance technique. Improvisations to increase the success rate can be attained by implementing modalities namely the neuro-stimulation and ultrasound but there is paucity of literature comparing these three approaches. Here we compare the three techniques in terms of the success rate.
MATERIALS AND METHODS


The primary outcome of this study was to compare the success rate of the three techniques and the secondary outcome was the blood or cerebrospinal fluid aspiration during the procedure. It was a prospective, randomized, open-label parallel group study. Three hundred children aged 1 to 5 years scheduled for circumcision, hypospadias repair and minor lower extremity surgeries were enrolled after taking written informed consent from the parents.
RESULTS


Demographic profiles were comparable in term of age, weight, gender distribution and types of surgeries. Success rates in landmark guided, neuro-stimulation guided and Ultrasound guided were 97, 97, and 98 percent respectively which was comparable (P=0.879). There was no significant difference in the incidence of blood or cerebrospinal fluid aspiration.
DISCUSSION


We found similar success rate of the caudal epidural block (CEB) by using landmark-guided, nerve stimulation-guided or ultrasound-guided techniques in children aged 1- 5 years with normal anatomy.",2021,"Success rates in landmark guided, neuro-stimulation guided and Ultrasound guided were 97, 97, and 98 percent respectively which was comparable (P=0.879).","['Three hundred children aged 1 to 5 years scheduled for circumcision, hypospadias repair and minor lower extremity surgeries were enrolled after taking written informed consent from the parents', 'children aged 1- 5 years with normal anatomy', 'Paediatric Caudal Epidural Anaesthesia']","['caudal epidural block (CEB) by using landmark-guided, nerve stimulation-guided or ultrasound-guided techniques', 'Landmark-guided, Nerve Stimulation-guided, and Ultrasound-guided Techniques']","['blood or cerebrospinal fluid aspiration', 'success rate', 'incidence of blood or cerebrospinal fluid aspiration']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0558337', 'cui_str': 'Hypospadias repair'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0187763', 'cui_str': 'Surgical procedure on lower extremity'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1269644', 'cui_str': 'Normal anatomy'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",300.0,0.0438397,"Success rates in landmark guided, neuro-stimulation guided and Ultrasound guided were 97, 97, and 98 percent respectively which was comparable (P=0.879).","[{'ForeName': 'Vrushali', 'Initials': 'V', 'LastName': 'Ponde', 'Affiliation': 'Surya Children Hospital, Mumbai, Maharashtra Department of Anaesthesiology and Critical Care, AIIMS, Bhubaneswar- 751019, Odisha Consultant Anesthesiologist, BIACH & RI, Hyderabad Department of Anaesthesiology, Lung Center of the Philippines.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': ''}, {'ForeName': 'Corinna J', 'Initials': 'CJ', 'LastName': 'Ongaigui', 'Affiliation': ''}, {'ForeName': 'Tripti', 'Initials': 'T', 'LastName': 'Nagdev', 'Affiliation': ''}]",The Clinical journal of pain,['10.1097/AJP.0000000000001003']
2304,34743579,"Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial.","BACKGROUND


We compared the tolerability and efficacy of erenumab, a monoclonal antibody binding to the calcitonin gene-related peptide receptor, to topiramate for migraine prophylaxis in adults.
METHODS


HER-MES was a 24-week, randomised, double-blind, double-dummy, controlled trial conducted in 82 sites in Germany. Patients with ≥4 migraine days per month and naïve to study drugs were randomly assigned (1:1) to either subcutaneous erenumab (70 or 140 mg/month) plus topiramate placebo (erenumab group) or oral topiramate at the individual dose with optimal efficacy (50-100 mg/day) plus erenumab placebo (topiramate group).The primary endpoint was medication discontinuation due to an adverse event during the double-blind phase. The proportion of patients that achieved ≥50% reduction from baseline in monthly migraine days during the last 3 months of the double-blind phase was a secondary endpoint.
RESULTS


Seven hundred and seventy-seven patients were randomised (from 22 February 2019 to 29 July, 2020) and 95.1% completed the study. In the erenumab group, 10.6% discontinued medication due to adverse events compared to 38.9% in the topiramate group (odds ratio, 0.19; 95% confidence interval 0.13-0.27;  p  < 0.001). Significantly more patients achieved a ≥50% reduction in monthly migraine days from baseline with erenumab (55.4% vs. 31.2%; odds ratio 2.76; 95% confidence interval 2.06-3.71;  p  < 0.001). No new safety signals occurred.
CONCLUSIONS


Erenumab demonstrated a favourable tolerability and efficacy profile compared to topiramate.Trial registration: ClinicalTrials.gov NCT03828539, URL: https://clinicaltrials.gov/ct2/show/NCT03828539.",2021,Significantly more patients achieved a ≥50% reduction in monthly migraine days from baseline with erenumab (55.4% vs. 31.2%; odds ratio 2.76; 95% confidence interval 2.06-3.71;  p  < 0.001).,"['adults', 'Patients with ≥4 migraine days per month and naïve to study drugs', 'Seven hundred and seventy-seven patients were randomised (from 22 February 2019 to 29 July, 2020) and 95.1% completed the study', 'HER-MES']","['subcutaneous erenumab (70 or 140\u2009mg/month) plus topiramate placebo (erenumab group) or oral topiramate', 'Erenumab versus topiramate', 'erenumab placebo (topiramate']","['adverse events', 'tolerability and efficacy profile']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",777.0,0.934165,Significantly more patients achieved a ≥50% reduction in monthly migraine days from baseline with erenumab (55.4% vs. 31.2%; odds ratio 2.76; 95% confidence interval 2.06-3.71;  p  < 0.001).,"[{'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ehrlich', 'Affiliation': 'Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Gendolla', 'Affiliation': 'Praxis Gendolla, Essen, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Heinze', 'Affiliation': 'The Kiel Migraine and Headache Centre, Kiel, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Novartis AG, New York, NY, USA.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Hours-Zesiger', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Nickisch', 'Affiliation': 'Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sieder', 'Affiliation': 'Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hentschke', 'Affiliation': 'Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Maier-Peuschel', 'Affiliation': 'Novartis Pharma GmbH, Nuremberg, Germany.'}]",Cephalalgia : an international journal of headache,['10.1177/03331024211053571']
2305,34743575,Trained Volunteers With Type 2 Diabetes Experience Significant Health Benefits When Providing Peer Support.,"Trained lay volunteers may have value in supporting lifestyle change programs in the prevention of type 2 diabetes, but the potential health benefits (or harms) experienced by these lay volunteers have not been well described. This is important, as this is an appealing model in terms of workforce planning. The aim of the prespecified quantitative study reported here, was to examine the possible health benefits or harms experienced by these trained lay volunteers with type 2 diabetes. In a large type 2 diabetes prevention program, we recruited and trained 104 lay volunteers with type 2 diabetes themselves, to act as diabetes prevention mentors and codeliver the lifestyle intervention. Mentors made motivational telephone calls to 461 participants randomized to one of the trial arms to encourage lifestyle changes. Weight, diet, physical activity, well-being, quality of life, diabetes-specific self-efficacy, and glycaemic control were measured at baseline, 12 and 24 months. Average mentor age was 62.0 years, 57 (54.8%) were male, 92 (88.5%) were overweight or obese (BMI>30 kg/m 2 ). At 12 months, mentor dietary behaviors (fat and fiber intake) improved significantly, sedentary time spent fell significantly, and diabetes specific self-efficacy scores significantly increased. These significant improvements, with no evidence of harms, suggest lay volunteers with type 2 diabetes codelivering a lifestyle intervention, may themselves experience health benefits from volunteering.",2021,"At 12 months, mentor dietary behaviors (fat and fiber intake) improved significantly, sedentary time spent fell significantly, and diabetes specific self-efficacy scores significantly increased.","['trained lay volunteers with type 2 diabetes', 'Average mentor age was 62.0 years, 57 (54.8%) were male, 92 (88.5%) were overweight or obese', 'Trained Volunteers With Type 2 Diabetes Experience Significant Health Benefits', '104 lay volunteers with type 2 diabetes themselves, to act as diabetes prevention mentors and codeliver the lifestyle intervention']",['BMI>30 kg'],"['Weight, diet, physical activity, well-being, quality of life, diabetes-specific self-efficacy, and glycaemic control', 'sedentary time spent fell significantly, and diabetes specific self-efficacy scores', 'mentor dietary behaviors (fat and fiber intake']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",461.0,0.0453649,"At 12 months, mentor dietary behaviors (fat and fiber intake) improved significantly, sedentary time spent fell significantly, and diabetes specific self-efficacy scores significantly increased.","[{'ForeName': 'Nikki J', 'Initials': 'NJ', 'LastName': 'Garner', 'Affiliation': 'Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, Norfolk, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pond', 'Affiliation': 'University of East Anglia, Norwich, Norfolk, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Auckland', 'Affiliation': 'Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, Norfolk, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Sampson', 'Affiliation': 'Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, Norfolk, UK.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/10901981211048823']
2306,34743554,Serial Assessment of High-Sensitivity Cardiac Troponin and the Effect of Dapagliflozin in Patients with Heart Failure with Reduced Ejection Fraction: An Analysis of the DAPA-HF Trial.,"Background:  Circulating high-sensitivity cardiac troponin T (hsTnT) predominantly reflects myocardial injury, and higher levels are associated with a higher risk of worsening heart failure (HF) and death in patients with HF with reduced ejection fraction (HFrEF). Less is known about the prognostic significance of changes in hsTnT over time, the effects of dapagliflozin on clinical outcomes in relation to baseline hsTnT levels, and the effect of dapagliflozin on hsTnT levels.  Methods:  DAPA-HF was a randomized, double-blind, placebo-controlled trial of dapagliflozin (10 mg daily) in patients with NYHA class II-IV symptoms and left ventricular ejection fraction ≤40% (median follow-up = 18.2 months). hsTnT (Roche Diagnostics) was measured at baseline in 3,112 patients and at 1 year in 2,506 patients. The primary endpoint was adjudicated worsening HF or cardiovascular death. Clinical endpoints were analyzed according to baseline hsTnT and change in hsTnT from baseline to 1 year. Comparative treatment effects on clinical endpoints with dapagliflozin vs. placebo were assessed by baseline hsTnT. The effect of dapagliflozin on hsTnT was explored.  Results:  Median baseline hsTnT concentration was 20.0 (25th-75th percentile, 13.7 to 30.2) ng/L. Over 1 year, 67.9% of patients had a ≥10% relative increase or decrease in hsTnT concentrations, and 43.5% had a ≥20% relative change. A stepwise gradient of higher risk for the primary endpoint was observed across increasing quartiles of baseline hsTnT concentration (adjusted hazard ratio [aHR] Q4 vs. Q1, 5.10; 95% CI, 3.67-7.08). Relative and absolute increases in hsTnT over 1 year were associated with higher subsequent risk of the primary endpoint. The relative reduction in the primary endpoint with dapagliflozin was consistent across quartiles of baseline hsTnT (p-interaction = 0.55), but patients in the top quartile tended to have the greatest absolute risk reduction (absolute risk difference, 7.5%; 95% CI, 1.0% - 14.0%). Dapagliflozin tended to attenuate the increase in hsTnT over time compared to placebo (relative least squares mean reduction, -3% [-6% to 0%]; p=0.076).  Conclusions:  Higher baseline hsTnT and greater increase in hsTnT over 1 year are associated with worse clinical outcomes. Dapagliflozin consistently reduced the risk of the primary endpoint, irrespective of baseline hsTnT levels.  Clinical Trial Registration:  URL: https://www.clinicaltrials.gov. Unique Identifier: NCT03036124.",2021,"The relative reduction in the primary endpoint with dapagliflozin was consistent across quartiles of baseline hsTnT (p-interaction = 0.55), but patients in the top quartile tended to have the greatest absolute risk reduction (absolute risk difference, 7.5%; 95% CI, 1.0% - 14.0%).","['Patients with Heart Failure with Reduced Ejection Fraction', '3,112 patients and at 1 year in 2,506 patients', 'patients with NYHA class II-IV symptoms and left ventricular ejection fraction ≤40% (median follow-up = 18.2 months', 'patients with HF with reduced ejection fraction (HFrEF']","['dapagliflozin', 'dapagliflozin vs. placebo', ':  Circulating high-sensitivity cardiac troponin T (hsTnT', 'hsTnT', 'Dapagliflozin', 'placebo']","['Median baseline hsTnT concentration', 'quartiles of baseline hsTnT concentration', 'hsTnT concentrations', 'adjudicated worsening HF or cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",3112.0,0.801448,"The relative reduction in the primary endpoint with dapagliflozin was consistent across quartiles of baseline hsTnT (p-interaction = 0.55), but patients in the top quartile tended to have the greatest absolute risk reduction (absolute risk difference, 7.5%; 95% CI, 1.0% - 14.0%).","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Chopra', 'Affiliation': 'Max Superspeciality Hospital, Saket, New Delhi, India.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City, MO.""}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Department of Cardiology, Montreal Heart Institute and Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hammarstedt', 'Affiliation': 'AstraZeneca, Goteborg, Sweden.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Goteborg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindholm', 'Affiliation': 'AstraZeneca, Goteborg, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'AstraZeneca, Goteborg, Sweden.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]",Circulation,['10.1161/CIRCULATIONAHA.121.057852']
2307,34743540,Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial.,"Background Although safety and tolerability of vericiguat were established in the VICTORIA (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction) trial in patients with heart failure with reduced ejection fraction, some subgroups may be more susceptible to symptomatic hypotension, such as older patients, those with lower baseline systolic blood pressure (SBP), or those concurrently taking angiotensin receptor neprilysin inhibitors. We described the SBP trajectories over time and compared the occurrence of symptomatic hypotension or syncope by treatment arm in potentially vulnerable subgroups in VICTORIA. We also evaluated the relation between the efficacy of vericiguat and baseline SBP. Methods and Results Among patients receiving at least 1 dose of the study drug (n=5034), potentially vulnerable subgroups were those >75 years old (n=1395), those with baseline SBP 100-110 mm Hg (n=1344), and those taking angiotensin receptor neprilysin inhibitors (n=730). SBP trajectory was plotted as mean change from baseline over time. The treatment effect on time to symptomatic hypotension or syncope was evaluated overall and by subgroup, and the primary efficacy composite outcome (heart failure hospitalization or cardiovascular death) across baseline SBP was examined using Cox proportional hazards models. SBP trajectories showed a small initial decline in SBP with vericiguat in those >75 years old (versus younger patients), as well as those receiving angiotensin receptor neprilysin inhibitors (versus none), with SBP returning to baseline thereafter. Patients with SBP <110 mm Hg at baseline showed a trend to increasing SBP over time, which was similar in both treatment arms. Safety event rates were generally low and similar between treatment arms within each subgroup. In Cox proportional hazards analysis, there were similar numbers of safety events with vericiguat versus placebo (adjusted hazard ratio [HR], 1.18; 95% CI, 0.99-1.39;  P =0.059). No difference existed between treatment arms in landmark analysis beginning after the titration phase (ie, post 4 weeks) (adjusted HR, 1.14; 95% CI, 0.93-1.38;  P =0.20). The benefit of vericiguat compared with placebo on the primary composite efficacy outcome was similar across the spectrum of baseline SBP ( P  for interaction=0.32). Conclusions These data demonstrate the safety of vericiguat in a broad population of patients with worsening heart failure with reduced ejection fraction, even among those predisposed to hypotension. Vericiguat's efficacy persisted regardless of baseline SBP. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02861534.",2021,"No difference existed between treatment arms in landmark analysis beginning after the titration phase (ie, post 4 weeks)","['patients receiving at least 1 dose of the study drug (n=5034), potentially vulnerable subgroups were those >75\xa0years old (n=1395), those with baseline SBP 100-110\xa0mm\xa0Hg (n=1344), and those taking angiotensin receptor neprilysin inhibitors (n=730', 'Patients with SBP', '110\xa0mm', 'Subjects With Heart Failure With Reduced Ejection Fraction) trial in patients with heart failure with reduced ejection fraction']",['placebo'],"['time to symptomatic hypotension or syncope', 'baseline systolic blood pressure (SBP', 'SBP trajectory', 'SBP', 'primary efficacy composite outcome (heart failure hospitalization or cardiovascular death', 'Safety event rates', 'Blood Pressure and Safety Events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.372245,"No difference existed between treatment arms in landmark analysis beginning after the titration phase (ie, post 4 weeks)","[{'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore & Duke-National University of Singapore Singapore.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research InstituteDuke University School of Medicine Durham NC.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Lopatin', 'Affiliation': 'Volgograd State Medical UniversityRegional Cardiology Centre Volgograd Volgograd Russian Federation.'}, {'ForeName': 'Jose B', 'Initials': 'JB', 'LastName': 'Vazquez-Tanus', 'Affiliation': 'Ponce School of Medicine Ponce Puerto Rico.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Siu', 'Affiliation': 'Li Ka Shing Faculty of Medicine The University of Hong Kong Hong Kong.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre University of Alberta Edmonton Canada.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Charité University MedicineGerman Heart Center Berlin Germany.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute Falls Church VA.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG Wuppertal Germany.'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Merck & Co. Inc. Kenilworth NJ.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research InstituteDuke University School of Medicine Durham NC.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research InstituteDuke University School of Medicine Durham NC.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre University of Alberta Edmonton Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.121.021094']
2308,34743533,Effect of Empagliflozin on Blood Volume Redistribution in Patients With Chronic Heart Failure and Reduced Ejection Fraction: An Analysis from the Empire HF Randomized Clinical Trial.,"Background:  Stressed blood volume (SBV) is a major determinant of systemic and pulmonary venous pressures which, in turn, determine left and right ventricular fillings and regulates cardiac output via the Frank-Starling mechanism. It is not known whether inhibition of the sodium-glucose cotransporter-2 (SGLT2) favorably affects SBV. We investigated the effect of empagliflozin on estimated stressed blood volume (eSBV) in patients with heart failure andreduced ejection fraction (HFrEF) compared to placebo.  Methods:  This was a post-hoc analysis of an investigator-initiated, double-blinded, placebo controlled, randomized trial. Seventy patients were assigned to empagliflozin 10 mg or matching placebo once-daily for 12 weeks. Patients underwent right heart catheterization at rest and during exercise at baseline and follow-up. The outcome was change in eSBV after 12 weeks of empagliflozin treatment over the full range of exercise, determined using a recently introduced analytical approach based on invasive hemodynamic assessment.  Results:  Patients with HFrEF, mean age, 57 years and mean ejection fraction 27 %, with 47 patients (71%) receiving diuretics were randomized. The effect of empagliflozin on eSBV over the full range of exercise loads showed a statistically significant reduction compared with placebo (-198.4 mL, 95%CI: -317.4; -79.3, p=0.001), a 9% decrease. The decrease in eSBV by empagliflozin was significantly correlated with the decrease in PCWP ((R= ̶ 0.33, p<0.0001). The effect of empagliflozin was consistent across subgroup analysis.  Conclusions:  Empagliflozin treatment significantly reduced stressed blood volume compared with placebo after 12 weeks of treatment in patients with stable chronic HFrEF during sub maximal exercise.  Registration:  URL: https://www.clinicaltrials.gov, Unique identifier: NCT03198585.",2021,"The effect of empagliflozin on eSBV over the full range of exercise loads showed a statistically significant reduction compared with placebo (-198.4 mL, 95%CI: -317.4; -79.3, p=0.001), a 9% decrease.","['Patients With Chronic Heart Failure and Reduced Ejection Fraction', 'patients with heart failure andreduced ejection fraction (HFrEF', 'patients with stable chronic HFrEF during sub maximal exercise', 'Results:  Patients with HFrEF, mean age, 57 years and mean ejection fraction 27 %, with 47 patients (71%) receiving diuretics were randomized', 'Seventy patients']","['Empagliflozin', 'empagliflozin 10 mg or matching placebo', 'placebo', ':  Stressed blood volume (SBV', 'empagliflozin', 'right heart catheterization at rest and during exercise at baseline and follow-up']","['eSBV', 'PCWP', 'Blood Volume Redistribution', 'stressed blood volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}]",70.0,0.234155,"The effect of empagliflozin on eSBV over the full range of exercise loads showed a statistically significant reduction compared with placebo (-198.4 mL, 95%CI: -317.4; -79.3, p=0.001), a 9% decrease.","[{'ForeName': 'Massar', 'Initials': 'M', 'LastName': 'Omar', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Steno Diabetes Center Odense, 5000 Odense C, Denmark; Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Burkhoff', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Frederiksen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 København Ã, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark.'}, {'ForeName': 'Mikael Kjær', 'Initials': 'MK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Cardiovascular Medicine, Mayo Clinic Hospital, Rochester, MN.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Jacob Eifer', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark.'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.121.009156']
2309,34743530,Estimation of DAPT Study Treatment Effects in Contemporary Clinical Practice: Findings from the EXTEND-DAPT Study.,"Background:  Differences in patient characteristics, changes in treatment algorithms, and advances in medical technology could each influence the applicability of older randomized trial results to contemporary clinical practice. The Dual Antiplatelet Therapy (DAPT) Study found that longer duration DAPT decreased ischemic events at the expense of greater bleeding, but subsequent evolution in stent technology and clinical practice may attenuate the benefit of prolonged DAPT in a contemporary population. We evaluated whether the DAPT Study population is different from a contemporary population of US patients receiving percutaneous coronary intervention (PCI), and estimated the treatment effect of extended duration antiplatelet therapy after PCI in this more contemporary cohort.  Methods:  We compared characteristics of drug-eluting stent (DES)-treated patients randomized in the DAPT Study to a sample of more contemporary DES-treated patients in the NCDR CathPCI Registry from July 2016-June 2017. After linking trial and registry data, we employed inverse-odds of trial participation weighting to account for patient and procedural characteristics and estimated a contemporary ""real-world"" treatment effect of 30 vs. 12 months of DAPT after coronary stent procedures.  Results:  The US DES-treated trial cohort included 8864 DAPT Study patients and the registry cohort included 568,540 patients. Compared to the trial population, registry patients had more comorbidities and were more likely to present with myocardial infarction and receive 2nd generation DES. After reweighting trial results to represent the registry population, there was no longer a significant effect of prolonged DAPT on reducing stent thrombosis (reweighted treatment effect: -0.40, 95% CI: -0.99%, 0.15%), major adverse cardiac and cerebrovascular events (reweighted treatment effect: -0.52, 95% CI: -2.62%, 1.03%), or myocardial infarction (reweighted treatment effect: -0.97%, 95% CI: -2.75%, 0.18%), but the increase in bleeding with prolonged DAPT persisted (reweighted treatment effect: 2.42%, 95% CI: 0.79%, 3.91%).  Conclusions:  Differences between patients and devices used in contemporary clinical practice compared with the DAPT Study were associated with attenuation of benefits and greater harms attributable to prolonged DAPT duration. These findings limit applicability of average treatment effects from the DAPT Study in modern clinical practice.",2021,"After reweighting trial results to represent the registry population, there was no longer a significant effect of prolonged DAPT on reducing stent thrombosis (reweighted treatment effect: -0.40, 95% CI: -0.99%, 0.15%), major adverse cardiac and cerebrovascular events (reweighted treatment effect:","['8864 DAPT Study patients and the registry cohort included 568,540 patients', 'DES)-treated patients randomized in the DAPT Study to a sample of more contemporary DES-treated patients in the NCDR CathPCI Registry from July 2016-June 2017']","['Dual Antiplatelet Therapy (DAPT', 'DAPT', 'percutaneous coronary intervention (PCI', 'drug-eluting stent']","['myocardial infarction', 'stent thrombosis', 'bleeding with prolonged DAPT', 'ischemic events', 'major adverse cardiac and cerebrovascular events']","[{'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",568540.0,0.0661985,"After reweighting trial results to represent the registry population, there was no longer a significant effect of prolonged DAPT on reducing stent thrombosis (reweighted treatment effect: -0.40, 95% CI: -0.99%, 0.15%), major adverse cardiac and cerebrovascular events (reweighted treatment effect:","[{'ForeName': 'Neel M', 'Initials': 'NM', 'LastName': 'Butala', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA; Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Kamil F', 'Initials': 'KF', 'LastName': 'Faridi', 'Affiliation': 'Section of Cardiovascular Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Tamez', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA.'}, {'ForeName': 'Jordan B', 'Initials': 'JB', 'LastName': 'Strom', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA.'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA; Biogen, Inc, Cambridge, MA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Secemsky', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mauri', 'Affiliation': 'Medtronic, Minneapolis, MN.'}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital Heart and Vascular Center, Cincinnati, OH.'}, {'ForeName': 'Jeptha P', 'Initials': 'JP', 'LastName': 'Curtis', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA; Baim Institute for Clinical Research, Boston, MA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Yeh', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA; Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA; Baim Institute for Clinical Research, Boston, MA.'}]",Circulation,['10.1161/CIRCULATIONAHA.121.056878']
2310,34743482,Sensory Based Feeding Intervention for Toddlers With Food Refusal: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the effect of sensory-based feeding treatment for toddlers with food refusal compared with only providing nutrition education.
METHODS


Thirty-two toddlers with food refusal were randomly assigned to an intervention group or the control group. Toddlers in the intervention group received the sensory-based feeding intervention and the duration was for 1 hour for 5 days per week for 4 weeks, and then 1 hour, once a week for 8 weeks. Subjects in both the intervention and control groups received nutritional education once every 4 weeks for 12 weeks. The participants were evaluated at their entry into the study and 12 weeks later based on height, weight, behavior at mealtime using the Behavioral Pediatrics Feeding Assessment Scale (BPFAS), and sensory processing ability using the Infant/Toddler Sensory Profile.
RESULTS


Sixteen toddlers were included in each group. Two subjects in the intervention group and four toddlers in the control group were excluded from the final analysis. Significant improvements in child or parent subscales of the BPFAS were observed in the intervention group. In contrast, there were no significant improvements in any BPFAS scores in the control group.
CONCLUSION


Sensory-based feeding intervention was effective for improving mealtime behavior in toddlers with food refusal. Therefore, a sensory-based feeding intervention could be considered as an intervention approach to address feeding disorders in toddlers.",2021,"In contrast, there were no significant improvements in any BPFAS scores in the control group.
","['toddlers with food refusal compared with only providing nutrition education', 'Thirty-two toddlers with food refusal', 'Sixteen toddlers', 'Toddlers With Food Refusal', 'toddlers with food refusal']","['sensory-based feeding intervention', 'sensory-based feeding treatment', 'Sensory-based feeding intervention', 'Sensory Based Feeding Intervention', 'nutritional education']","['child or parent subscales of the BPFAS', 'BPFAS scores', 'Behavioral Pediatrics Feeding Assessment Scale (BPFAS), and sensory processing ability using the Infant/Toddler Sensory Profile']","[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0424424', 'cui_str': 'Refusing food'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C2732625', 'cui_str': 'Sensory profile'}]",32.0,0.0160413,"In contrast, there were no significant improvements in any BPFAS scores in the control group.
","[{'ForeName': 'Ah-Ran', 'Initials': 'AR', 'LastName': 'Kim', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong-Yi', 'Initials': 'JY', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sook-Hee', 'Initials': 'SH', 'LastName': 'Yi', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul Rehabilitation Hospital, Seoul, Korea.'}, {'ForeName': 'Eun-Hye', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Occupational Therapy, Seoul Rehabilitation Hospital, Seoul, Korea.'}]",Annals of rehabilitation medicine,['10.5535/arm.21076']
2311,34743455,[Lesion removal plus whole breast exploration and washing plus micro-plastic procedures in the treatment of granulomatous lobular mastitis: a randomized controlled study].,"Objective:  To examine the effect of""lesion removal plus whole breast exploration and washing plus micro-plastic surgery""in granulomatous lobular mastitis.  Methods:  A single-center prospective randomized controlled study method was used to enroll patients diagnosed with granulomatous lobular mastitis for whom surgical procedures were projected from March 2017 to September 2019 at Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University. The sample size is determined by the superiority test. Based on the literatures and the previous work, the two groups require 97 cases. Fifty-two patients underwent""lesion removal+whole breast exploration and washing plus micro-plastic surgery""(observation group). Forty-five cases underwent""empirical breast lesion resection plus fascia tissue flap plasty plus nipple and areola correction""(control group). The primary study endpoint is the recurrence rate, and the secondary study endpoints include surgical complications, incision healing time, and postoperative patient satisfaction. Independent sample  t  test, Wilcoxon rank-sum test, χ² test and Fisher exact test were used for comparison between groups.  Results:  All procedures were completed successful, with no severe complications. All patients were followed up for (15.2±1.9) months (range: 12 to 24 months). There were no significant differences in incidence of postoperative complications (7.7% (4/52)  vs.  6.7%(3/45),  P= 1), drainage time ((8.6±0.6) days  vs.  (8.4±0.8) days,  t= 1.921,  P= 0.053) and hospital stay ((7.7±0.6) days  vs.  (7.6±0.5) days,  t= 1.633,  P= 0.102) between the two groups. The recurrence rate of the observation group was lower significantly than that of the control group (3.8% (2/52)  vs.  24.4%(11/45), χ²=8.819,  P= 0.003). The observation group had better cosmetic effects ( Z= -2.657,  P= 0.008) and patient satisfaction than control group ( Z= -5.730,  P= 0.000).  Conclusion:  The ""lesion removal plus whole breast exploration and flushing plus micro-plastic surgery"" has a good therapeutic effect and cosmetic value for patients with refractory granulomatous lobular mastitis.",2021,"The observation group had better cosmetic effects ( Z= -2.657,  P= 0.008) and patient satisfaction than control group ( Z= -5.730,  P= 0.000).  ","['Fifty-two patients underwent""lesion removal+whole breast exploration and washing plus micro-plastic surgery""(observation group', 'granulomatous lobular mastitis', 'patients with refractory granulomatous lobular mastitis', 'enroll patients diagnosed with granulomatous lobular mastitis for whom surgical procedures were projected from March 2017 to September 2019 at Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University']","['Lesion removal plus whole breast exploration and washing plus micro-plastic procedures', 'underwent""empirical breast lesion resection plus fascia tissue flap plasty plus nipple and areola correction""(control', 'lesion removal plus whole breast exploration and flushing plus micro-plastic surgery']","['drainage time', 'surgical complications, incision healing time, and postoperative patient satisfaction', 'incidence of postoperative complications', 'recurrence rate', 'patient satisfaction', 'cosmetic effects', 'hospital stay']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439667', 'cui_str': 'Granulomatous'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0567489', 'cui_str': 'Lesion of breast'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.023191,"The observation group had better cosmetic effects ( Z= -2.657,  P= 0.008) and patient satisfaction than control group ( Z= -5.730,  P= 0.000).  ","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Wu', 'Affiliation': 'Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.'}, {'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'He', 'Affiliation': 'Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.'}, {'ForeName': 'J X', 'Initials': 'JX', 'LastName': 'Hou', 'Affiliation': 'Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Lan', 'Affiliation': 'Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.'}, {'ForeName': 'Q Y', 'Initials': 'QY', 'LastName': 'Feng', 'Affiliation': 'Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.'}, {'ForeName': 'L W', 'Initials': 'LW', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.'}, {'ForeName': 'Q Q', 'Initials': 'QQ', 'LastName': 'Yuan', 'Affiliation': 'Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.'}, {'ForeName': 'Y Q', 'Initials': 'YQ', 'LastName': 'Liao', 'Affiliation': 'Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.'}]",Zhonghua wai ke za zhi [Chinese journal of surgery],['10.3760/cma.j.cn112139-20201207-00845']
2312,34743440,[A place of silodosin in the treatment of LUTS/BPH according to evidence-based medicine and real clinical practice].,"Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) are common disorder in older men. The mainstay of conservative treatment for BPH is 1-adrenoblockers. A review of the literature on silodosin, a selective -adrenergic blocker, is discussed in the article. In clinical studies, there was a significant improvement in IPSS scores and maximum urinary flow rate in patients who received silodosin at a daily dose of 8 mg compared to those receiving placebo. It should be noted that silodosin has demonstrated long-term safety and early onset of efficacy. Compelling literature data to support the clinical benefit of silodosin for the treatment of LUTS associated with BPH is presented.",2021,"In clinical studies, there was a significant improvement in IPSS scores and maximum urinary flow rate in patients who received silodosin at a daily dose of 8 mg compared to those receiving placebo.",['older men'],"['silodosin', 'placebo']",['IPSS scores and maximum urinary flow rate'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1870115', 'cui_str': 'silodosin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}]",,0.116283,"In clinical studies, there was a significant improvement in IPSS scores and maximum urinary flow rate in patients who received silodosin at a daily dose of 8 mg compared to those receiving placebo.","[{'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Kotov', 'Affiliation': 'Department of Urology and Andrology of Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Bogdanov', 'Affiliation': 'Department of Urology and Andrology of Pirogov Russian National Research Medical University, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
2313,34743382,Ahead of maturation: Enhanced speech envelope training boosts rise time discrimination in pre-readers at cognitive risk for dyslexia.,"Dyslexia has frequently been related to atypical auditory temporal processing and speech perception. Results of studies emphasizing speech onset cues and reinforcing the temporal structure of the speech envelope, i.e. envelope enhancement, demonstrated reduced speech perception deficits in individuals with dyslexia. The use of this strategy as auditory intervention might thus reduce some of the deficits related to dyslexia. Importantly, reading-skill interventions are most effective when they are provided during kindergarten and first grade. Hence, we provided a tablet-based 12-week auditory and phonics-based intervention to pre-readers at cognitive risk for dyslexia and investigated the effect on auditory temporal processing with a rise time discrimination task. Ninety-one pre-readers at cognitive risk for dyslexia (aged 5-6) were assigned to two groups receiving a phonics-based intervention and playing a story listening game either with (n = 31) or without (n = 31) envelope enhancement or a third group playing control games and listening to non-enhanced stories (n = 29). Rise time discrimination was measured directly before, directly after and one year after the intervention. While the groups listening to non-enhanced stories mainly improved after the intervention during first grade, the group listening to enhanced stories improved during the intervention in kindergarten and subsequently remained stable during first grade. Hence, an envelope enhancement intervention improves auditory processing skills important for the development of phonological skills. This occurred before the onset of reading instruction, preceding the maturational improvement of these skills, hence potentially giving at risk children a head start when learning to read. This article is protected by copyright. All rights reserved.",2021,"While the groups listening to non-enhanced stories mainly improved after the intervention during first grade, the group listening to enhanced stories improved during the intervention in kindergarten and subsequently remained stable during first grade.","['pre-readers at cognitive risk for dyslexia', 'individuals with dyslexia', 'Ninety-one pre-readers at cognitive risk for dyslexia (aged 5-6']",['phonics-based intervention and playing a story listening game either with (n = 31) or without (n = 31) envelope enhancement or a third group playing control games and listening to non-enhanced stories'],"['speech perception deficits', 'auditory processing skills', 'Rise time discrimination']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442749', 'cui_str': '6/5'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]","[{'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",,0.0171163,"While the groups listening to non-enhanced stories mainly improved after the intervention during first grade, the group listening to enhanced stories improved during the intervention in kindergarten and subsequently remained stable during first grade.","[{'ForeName': 'Shauni', 'Initials': 'S', 'LastName': 'Van Herck', 'Affiliation': 'Research Group ExpORL, Department of Neurosciences, KU Leuven, Belgium.'}, {'ForeName': 'Femke Vanden', 'Initials': 'FV', 'LastName': 'Bempt', 'Affiliation': 'Research Group ExpORL, Department of Neurosciences, KU Leuven, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Economou', 'Affiliation': 'Research Group ExpORL, Department of Neurosciences, KU Leuven, Belgium.'}, {'ForeName': 'Jolijn', 'Initials': 'J', 'LastName': 'Vanderauwera', 'Affiliation': 'Parenting and Special Education Research Unit, Faculty of Psychology and Educational.'}, {'ForeName': 'Toivo', 'Initials': 'T', 'LastName': 'Glatz', 'Affiliation': 'Research Group ExpORL, Department of Neurosciences, KU Leuven, Belgium.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Dieudonné', 'Affiliation': 'Research Group ExpORL, Department of Neurosciences, KU Leuven, Belgium.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Vandermosten', 'Affiliation': 'Research Group ExpORL, Department of Neurosciences, KU Leuven, Belgium.'}, {'ForeName': 'Pol', 'Initials': 'P', 'LastName': 'Ghesquière', 'Affiliation': 'Parenting and Special Education Research Unit, Faculty of Psychology and Educational.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wouters', 'Affiliation': 'Research Group ExpORL, Department of Neurosciences, KU Leuven, Belgium.'}]",Developmental science,['10.1111/desc.13186']
2314,34743379,"The impact of a modified carbohydrate formula, and its constituents, on glycaemic control and inflammatory markers: A nested mechanistic sub-study.","BACKGROUND


Hyperglycaemia occurs frequently in the critically ill. Dietary intake of advanced glycation end-products (AGEs), specifically Nε-(carboxymethyl)lysine (CML), may exacerbate hyperglycaemia through perturbation of insulin sensitivity. The present study aimed to determine whether the use of nutritional formulae, with varying AGE loads, affects the amount of insulin administered and inflammation.
METHODS


Exclusively tube fed patients (n = 35) were randomised to receive Nutrison Protein Plus Multifibre®, Diason® or Glucerna Select®. Insulin administration was standardised according to protocol based on blood glucose (<10 mmol L -1  ). Samples were obtained at randomisation and 48 h later. AGEs in nutritional formula, plasma and urine were measured using mass spectrometry. Plasma inflammatory markers were measured using an enzyme-linked immunosorbent assay and multiplex bead-based assays.
RESULTS


AGE concentrations of CML in nutritional formulae were greatest with delivery of Nutrison Protein Plus® (mean [SD]; 6335 pmol mol -1  [2436]) compared to Diason® (4836 pmol mol -1  [1849]) and Glucerna Select® (4493 pmol mol -1  [1829 pmol mol -1  ]) despite patients receiving similar amounts of energy (median [interquartile range]; 12 MJ [8.2-13.7 MJ], 11.5 MJ [8.3-14.5 MJ], 11.5 MJ [8.3-14.5 MJ]). More insulin was administered with Nutrison Protein Plus® (2.47 units h -1  [95% confidence interval (CI) = 1.57-3.37 units h -1  ]) compared to Diason® (1.06 units h -1  [95% CI = 0.24-1.89 units h -1  ]) or Glucerna Select® (1.11 units h -1  [95% CI = 0.25-1.97 units h -1  ]; p = 0.04). Blood glucose concentrations were similar. There were associations between greater insulin administration and reductions in circulating interleukin-6 (r = -0.46, p < 0.01), tumour necrosis factor-α (r = -0.44, p < 0.05), high sensitivity C-reactive protein (r = -0.42, p < 0.05) and soluble receptor for advanced glycation end-products (r = -0.45, p < 0.01) concentrations.
CONCLUSIONS


The administration of greater AGE load in nutritional formula potentially increases the amount of insulin required to maintain blood glucose within a normal range during critical illness. There was an inverse relationship between exogenous insulin and plasma inflammatory markers.",2021,There were associations between greater insulin administration and reductions in circulating interleukin-6,"['Exclusively tube fed patients (n\u2009=\u200935', 'patients receiving similar amounts of energy (median [interquartile range]; 12\u2009MJ [8.2-13.7\u2009MJ], 11.5\u2009MJ [8.3-14.5\u2009MJ], 11.5\u2009MJ [8.3-14.5\u2009MJ']","['Diason®', 'Nutrison Protein Plus Multifibre®, Diason® or Glucerna Select®', 'advanced glycation end-products (AGEs), specifically Nε-(carboxymethyl)lysine (CML', 'Nutrison Protein Plus®']","['tumour necrosis factor-α ', 'Plasma inflammatory markers', 'Blood glucose concentrations', 'high sensitivity C-reactive protein ', 'exogenous insulin and plasma inflammatory markers', 'soluble receptor for advanced glycation end-products', 'circulating interleukin-6']","[{'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517534', 'cui_str': '11.5'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0726369', 'cui_str': 'Glucerna'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0101725', 'cui_str': 'Receptor for Advanced Glycation Endproducts'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.128796,There were associations between greater insulin administration and reductions in circulating interleukin-6,"[{'ForeName': ""Ra'eesa"", 'Initials': 'R', 'LastName': 'Doola', 'Affiliation': 'Princess Alexandra Hospital, Mater Research Institute, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'The Royal Melbourne Hospital, The University of Melbourne and Mater Research Institute - The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Barrett', 'Affiliation': 'Mater Health Services, Mater Research Institute\xa0-\xa0The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Okano', 'Affiliation': 'Mater Research Institute\xa0-\xa0Statistics Unit, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Tolcher', 'Affiliation': 'System Planning Branch, Strategy Policy and Planning Division, Brisbane, QLD, Australia.'}, {'ForeName': 'Kye', 'Initials': 'K', 'LastName': 'Gregory', 'Affiliation': 'SHECC IMT, Queensland Health, Brisbane, QLD, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Schalkwijk', 'Affiliation': 'Cardiovascular Research Institute Maastricht (CARIM), Maastricht, Maastricht University Medical Centre, Netherlands, The Netherlands.'}, {'ForeName': 'Alwyn S', 'Initials': 'AS', 'LastName': 'Todd', 'Affiliation': 'Mater Research Institute - The University of Queensland and Menzies Health Institute Brisbane, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'Josephine M', 'Initials': 'JM', 'LastName': 'Forbes', 'Affiliation': 'Mater Research Institute\xa0-\xa0The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Sturgess', 'Affiliation': 'Mater Research Institute - The University of Queensland, Brisbane, QLD, Australia.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12959']
2315,34743745,"Efficacy of Bushen Huatan Decoction combined with Baduanjin in the treatment of polycystic ovary syndrome with insulin resistance (IR-PCOS), kidney deficiency and phlegm dampness: study protocol for a randomized controlled trial.","BACKGROUND


Polycystic ovary syndrome (PCOS) is a common reproductive endocrine disease in women. Insulin resistance (IR) has emerged as a central contributor to the pathogenesis of this disease. According to traditional Chinese medicine (TCM), kidney deficiency is the main syndrome of PCOS. The deficiency of the kidney cannot vaporize water-dampness, and the retention of water-dampness accumulates into phlegm dampness stagnation, resulting in visceral dysfunction and metabolic disorder. TCM involving syndrome differentiation and treatment is widely used to adjust women's menstrual cycles. Our patented formula Bushen Huatan Decoction (BSHTD) has been proven to be effective in the clinical treatment of IR-PCOS. Baduanjin also plays an important role in improving metabolic syndrome through lifestyle intervention. This study investigates the clinical efficacy of Bushen Huatan Decoction combined with Baduanjin in IR-PCOS, to form a specific TCM-behaviour intervention plan in the treatment of IR-PCOS.
METHODS/DESIGN


This is a randomized controlled trial involving 190 participants diagnosed with IR-PCOS. All participants will be randomly allocated into 5 groups: group A will receive metformin; group B, BSHTD; group C, Baduanjin; group D, BSHTD combined with metformin; and group E, BSHTD combined with Baduanjin. One course of treatment lasts 3 months, a total of two courses. The primary outcomes are changes in the homeostatic model assessment of insulin resistance (HOMA-IR) and improvements in the oral glucose tolerance test (OGTT) and insulin-releasing test (INS). The secondary outcomes are improvements in the menstrual cycle, ovulation rate, clinical pregnancy rate, basic serum sex hormone levels, free androgen index (FAI), Ferriman-Gallwey scores, body mass index (BMI) and TCM syndrome scores. The related observation indexes will be collected at baseline, during the process of treatment and at the 6-month follow-up. Simultaneously, close monitoring of possible adverse events will be performed throughout the trial process.
DISCUSSION


This trial will investigate the efficacy of the comprehensive intervention program of Bushen Huatan Decoction combined with Baduanjin on the adjustment of the menstrual cycle, improvement of insulin resistance and correction of glucose metabolism disorder in IR-PCOS patients. It is expected to form an alternative treatment of TCM-behaviour intervention therapy for IR-PCOS and promote the Chinese fitness Qigong Baduanjin in the application of lifestyle diseases.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR2100043415 . Registered on 15 February 2021.",2021,"The secondary outcomes are improvements in the menstrual cycle, ovulation rate, clinical pregnancy rate, basic serum sex hormone levels, free androgen index (FAI), Ferriman-Gallwey scores, body mass index (BMI) and TCM syndrome scores.","['polycystic ovary syndrome with insulin resistance (IR-PCOS), kidney deficiency and phlegm dampness', 'IR-PCOS patients', 'women', 'Polycystic ovary syndrome (PCOS', '190 participants diagnosed with IR-PCOS']","['Baduanjin; group D, BSHTD combined with metformin; and group E, BSHTD combined with Baduanjin', 'TCM', 'patented formula Bushen Huatan Decoction (BSHTD', 'Bushen Huatan Decoction combined with Baduanjin', 'metformin']","['Insulin resistance (IR', 'homeostatic model assessment of insulin resistance (HOMA-IR) and improvements in the oral glucose tolerance test (OGTT) and insulin-releasing test (INS', 'menstrual cycle, ovulation rate, clinical pregnancy rate, basic serum sex hormone levels, free androgen index (FAI), Ferriman-Gallwey scores, body mass index (BMI) and TCM syndrome scores']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0030650', 'cui_str': 'Patents'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]",190.0,0.104667,"The secondary outcomes are improvements in the menstrual cycle, ovulation rate, clinical pregnancy rate, basic serum sex hormone levels, free androgen index (FAI), Ferriman-Gallwey scores, body mass index (BMI) and TCM syndrome scores.","[{'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Qian', 'Affiliation': 'Department of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Pathology, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Laboratory Medicine, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.'}, {'ForeName': 'Mengyu', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Department of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.'}, {'ForeName': 'Minggang', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China. weiminggang@suda.edu.cn.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China. zjgzywlh@njucm.edu.cn.'}]",Trials,['10.1186/s13063-021-05770-z']
2316,34743721,The impact of participant mental health on attendance and engagement in a trial of behavioural weight management programmes: secondary analysis of the WRAP randomised controlled trial.,"BACKGROUND


Low attendance and engagement in behavioural weight management trials are common. Mental health may play an important role, however previous research exploring this association is limited with inconsistent findings. We aimed to investigate whether mental health was associated with attendance and engagement in a trial of behavioural weight management programmes.
METHODS


This is a secondary data analysis of the Weight loss referrals for adults in primary care (WRAP) trial, which randomised 1267 adults with overweight or obesity to brief intervention, WW (formerly Weight Watchers) for 12-weeks, or WW for 52-weeks. We used regression analyses to assess the association of baseline mental health (depression and anxiety (by Hospital Anxiety and Depression Scale), quality of life (by EQ5D), satisfaction with life (by Satisfaction with Life Questionnaire)) with programme attendance and engagement in WW groups, and trial attendance in all randomised groups.
RESULTS


Every one unit of baseline depression score was associated with a 1% relative reduction in rate of WW session attendance in the first 12 weeks (Incidence rate ratio [IRR] 0.99; 95% CI 0.98, 0.999). Higher baseline anxiety was associated with 4% lower odds to report high engagement with WW digital tools (Odds ratio [OR] 0.96; 95% CI 0.94, 0.99). Every one unit of global quality of life was associated with 69% lower odds of reporting high engagement with the WW mobile app (OR 0.31; 95% CI 0.15, 0.64). Greater symptoms of depression and anxiety and lower satisfaction with life at baseline were consistently associated with lower odds of attending study visits at 3-, 12-, 24-, and 60-months.
CONCLUSIONS


Participants were less likely to attend programme sessions, engage with resources, and attend study assessments when reporting poorer baseline mental health. Differences in attendance and engagement were small, however changes may still have a meaningful effect on programme effectiveness and trial completion. Future research should investigate strategies to maximise attendance and engagement in those reporting poorer mental health.
TRIAL REGISTRATION


The original trial ( ISRCTN82857232 ) and five year follow up ( ISRCTN64986150 ) were prospectively registered with Current Controlled Trials on 15/10/2012 and 01/02/2018.",2021,"Greater symptoms of depression and anxiety and lower satisfaction with life at baseline were consistently associated with lower odds of attending study visits at 3-, 12-, 24-, and 60-months.
","['adults in primary care (WRAP) trial, which randomised 1267 adults with overweight or obesity to brief intervention, WW (formerly Weight Watchers) for 12-weeks, or WW for 52-weeks']",[],"['global quality of life', 'Greater symptoms of depression and anxiety and lower satisfaction with life', 'rate of WW session attendance', 'baseline mental health (depression and anxiety (by Hospital Anxiety and Depression Scale), quality of life (by EQ5D), satisfaction with life (by Satisfaction with Life Questionnaire', 'Higher baseline anxiety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439230', 'cui_str': 'week'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High'}]",1267.0,0.37593,"Greater symptoms of depression and anxiety and lower satisfaction with life at baseline were consistently associated with lower odds of attending study visits at 3-, 12-, 24-, and 60-months.
","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Jones', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, UK. rj397@cam.ac.uk.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mueller', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'Department of Medicine, University College London, London, UK.'}, {'ForeName': 'Robbie', 'Initials': 'R', 'LastName': 'Duschinsky', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, UK.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-021-01216-6']
2317,34743701,The movement-to-music (M2M) study: study protocol for a randomized controlled efficacy trial examining a rhythmic teleexercise intervention for people with physical disabilities.,"BACKGROUND


People with physical disabilities need exercise routines that are enjoyable, readily available in the home, adapted to their functional level, and eliminate common barriers to exercise participation related to transportation and time commitment. The purpose of the movement-to-music (M2M) study is to address these issues by establishing a remotely delivered, rhythmic exercise program for people with physical disabilities.
METHODS


The study is a two-arm randomized controlled efficacy trial examining a 12-week remotely delivered M2M intervention (eM2M) in 108 people with physical disabilities. The primary outcomes are changes in cardiorespiratory fitness and muscle strength at post 12-week intervention.
DISCUSSION


The eM2M study will enhance our understanding of an alternative intervention design and delivery mode that removes common barriers to exercise participation experienced by people with physical disabilities. The eM2M intervention may be an alternative option for people with physical disabilities to obtain regular exercise, especially during a pandemic when exercising in indoor facilities may be problematic.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03797378. Registered on January 9, 2019, with the trial name ""Movement-to-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study (M2M LEADERS)"".",2021,The eM2M study will enhance our understanding of an alternative intervention design and delivery mode that removes common barriers to exercise participation experienced by people with physical disabilities.,"['People with physical disabilities', 'people with physical disabilities', '108 people with physical disabilities']","['M2M intervention (eM2M', 'rhythmic exercise program', 'rhythmic teleexercise intervention']",['changes in cardiorespiratory fitness and muscle strength'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",108.0,0.0405131,The eM2M study will enhance our understanding of an alternative intervention design and delivery mode that removes common barriers to exercise participation experienced by people with physical disabilities.,"[{'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Young', 'Affiliation': 'UAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA. hjyoung@uab.edu.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Lai', 'Affiliation': 'UAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Mehta', 'Affiliation': 'UAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Mohanraj', 'Initials': 'M', 'LastName': 'Thirumalai', 'Affiliation': 'UAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jereme', 'Initials': 'J', 'LastName': 'Wilroy', 'Affiliation': 'UAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Yates', 'Affiliation': 'UAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Kane', 'Affiliation': 'UAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Rimmer', 'Affiliation': 'UAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Trials,['10.1186/s13063-021-05751-2']
2318,34743695,The relationship between arterial stiffness index and coronary heart disease and its severity.,"BACKGROUND


Arterial stiffness index (ASI) is closely related to coronary atherosclerosis. This study aims to explore whether ASI can predict coronary heart disease (CHD) and its severity.
METHODS


In this study, a total of 726 patients with suspected CHD were recruited. Based on coronary angiography results, the subjects were assigned into three groups: the control group (without obvious coronary artery disease), single-vessel disease group, and multi-vessel disease group (the number of vessels diseased ≥ 2). At the same time, according to the results of angiography, myocardial enzyme spectrum, electrocardiogram, color Doppler echocardiography and clinical manifestations, these patients were divided into four groups: the control group, stable angina (SA) Group, unstable angina (UA) group, and acute myocardial infarction (AMI) group. We have compared whether there were differences in ASI and related baseline data between groups. Receiver operating curve (ROC) analysis was conducted to determine whether ASI could predict CHD and evaluate the severity.
RESULTS


ASI was positively correlated with the number of diseased branches of coronary artery. The value of ASI was increased as the number of the diseased branches increased. The ASI value in the SA group was significantly higher compared with the control group. Furthermore, the ASI value in the UA and AMI groups was remarkably increased compared with the control and SA groups. The results of ROC analysis indicated that the sensitivity and specificity of ASI was 71.0% and 85.4% in diagnosing CHD, respectively. While ASI was used in predicting the severity of CHD, the sensitivity was 72.1% and specificity 57.9%.
CONCLUSION


ASI is of great value in the diagnosis of coronary heart disease and the prediction of its severity.",2021,The ASI value in the SA group was significantly higher compared with the control group.,['726 patients with suspected CHD were recruited'],"['ASI', 'control group (without obvious coronary artery disease), single-vessel disease group, and multi-vessel disease group', 'control group, stable angina (SA) Group, unstable angina (UA']","['value of ASI', 'number of diseased branches of coronary artery', 'sensitivity and specificity of ASI', 'ASI value', 'severity of CHD, the sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0856737', 'cui_str': 'Single vessel disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",726.0,0.0368186,The ASI value in the SA group was significantly higher compared with the control group.,"[{'ForeName': 'Longjian', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Hebei Medical University, 361# Zhongshan east road, Shijiazhuang, 050017, Hebei Province, China.'}, {'ForeName': 'Dasheng', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Wannan Medical College, 10# Kangfu road, Wuhu, 241000, Anhui Province, China.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Yangzhou University, 41# Taizhou Road, Yangzhou, 225000, Jiangsu Province, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Yangzhou University, 41# Taizhou Road, Yangzhou, 225000, Jiangsu Province, China. zhanghao1991cz@163.com.'}]",BMC cardiovascular disorders,['10.1186/s12872-021-02350-6']
2319,34743682,Body mass index and physical activity in seven-year-old children whose mothers exercised during pregnancy: follow-up of a multicentre randomised controlled trial.,"BACKGROUND


There are limited data on long-term outcomes of children whose mothers have followed exercise interventions during pregnancy. The aim of this paper was to investigate whether regular moderate intensity exercise during pregnancy affected the children's body mass index (BMI) and physical activity (PA) at 7 years of age, and determine the relationship between children's and mothers' BMI and PA.
METHODS


This was a follow-up of a multicentre randomised controlled trial, carried out at St. Olavs Hospital, Trondheim University Hospital, and Stavanger University Hospital, Norway (2007-2009 and 2014-2016). Women were randomised to follow a 12-week structured exercise protocol or standard antenatal care during pregnancy. At the 7-year follow-up, parents reported their child's height, weight, and PA. The mothers also reported their own weight and PA. Main outcome variables were BMI, frequency and duration of moderate to vigorous PA (MVPA), and intensity of PA.
RESULTS


A total of 855 women were randomised to exercise (n = 429) or standard antenatal care (n = 426) during pregnancy. At follow-up, 164 (38.2%) children and mothers in the intervention group and 117 (27.5%) in the control group participated. We found no group differences in the children's iso-BMI or PA. Findings were similar when we performed stratified analyses by sex, except boys in the control group spent more time on electrical devices than boys in the intervention group. Subgroup analyses of children of mothers who adhered to the exercise protocol and sensitivity analyses excluding children born preterm, children admitted to the neonatal intensive care unit, and children with diseases or health problems at the 7-year follow-up, did not change the results. Children's BMI, weekly leisure time MVPA and intensity of PA correlated with mothers' BMI, daily exercise, and intensity of exercise.
CONCLUSIONS


Regular moderate intensity exercise during pregnancy did not affect BMI or PA of the children at 7 years. Good maternal health should be encouraged as it may influence the health of the next generation.
TRIAL REGISTRATION


The initial RCT study was registered in ClinicalTrials.gov NCT00476567 .",2021,"Findings were similar when we performed stratified analyses by sex, except boys in the control group spent more time on electrical devices than boys in the intervention group.","['A total of 855 women', 'carried out at St. Olavs Hospital, Trondheim University Hospital, and Stavanger University Hospital, Norway (2007-2009 and 2014-2016', 'seven-year-old children whose mothers exercised during pregnancy', 'children born preterm, children admitted to the neonatal intensive care unit, and children with diseases or health problems at the 7-year follow-up']","['structured exercise protocol or standard antenatal care during pregnancy', 'standard antenatal care', 'regular moderate intensity exercise']","['BMI, frequency and duration of moderate to vigorous PA (MVPA), and intensity of PA', ""Children's BMI, weekly leisure time MVPA and intensity of PA correlated with mothers' BMI, daily exercise, and intensity of exercise"", 'time on electrical devices', 'Body mass index and physical activity', ""children's iso-BMI or PA"", ""children's body mass index (BMI) and physical activity (PA""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}]",855.0,0.018011,"Findings were similar when we performed stratified analyses by sex, except boys in the control group spent more time on electrical devices than boys in the intervention group.","[{'ForeName': 'Karen Alterhaug', 'Initials': 'KA', 'LastName': 'Bjøntegaard', 'Affiliation': 'Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Signe Nilssen', 'Initials': 'SN', 'LastName': 'Stafne', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Mørkved', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Kjell Åsmund', 'Initials': 'KÅ', 'LastName': 'Salvesen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Kari Anne I', 'Initials': 'KAI', 'LastName': 'Evensen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. karianne.i.evensen@ntnu.no.'}]",BMC pediatrics,['10.1186/s12887-021-02952-1']
2320,34743677,The Impact of Depression and Exercise Self-Efficacy on Benefits of Pulmonary Rehabilitation in Veterans with COPD.,"Pulmonary rehabilitation (PR) improves health-related quality of life (HRQoL) and exercise capacity. Little is known about the impact of depression symptoms and exercise self-efficacy on improvements in these key PR outcomes. This study examined the impact of baseline depression status and change in depression symptoms (Beck Depression Inventory-II [BDI-II] score) over the course of PR on change in HRQoL assessed by the Chronic Respiratory Disease Questionnaire-Self Reported (CRQ-SR) and exercise capacity as measured by the 6-Minute Walk Test (6MWT). We also examined whether baseline exercise self-efficacy moderated the association between baseline depression symptoms and change in these key PR outcomes. We studied 112 US veterans (aged 70.38 ± 8.49 years) with chronic obstructive pulmonary disease (COPD) who completed PR consisting of twice-weekly 2-hour classes for 18 sessions. Depressed (BDI-II >13) and nondepressed (BDI-II ≤13) patients at baseline demonstrated comparable and significant improvement in CRQ-SR total score, subscales, and 6MWT. Greater reduction in depression over the course of treatment was significantly associated with greater improvement in CRQ-SR total score and the following subscales: fatigue, mastery, and emotional function. Change in depression did not predict change in 6MWT distance. Baseline exercise self-efficacy moderated the association between baseline depression symptoms and change in CRQ-SR fatigue. Specifically, when baseline exercise self-efficacy was <30.4, greater baseline depression was associated with less improvement in CRQ-SR fatigue. When baseline self-efficacy was >152.0, greater baseline depression was associated with greater improvement in CRQ-SR fatigue. PR programs should address mood and confidence to exercise given their impact on key PR outcomes.",2021,"Greater reduction in depression over the course of treatment was significantly associated with greater improvement in CRQ-SR total score and the following subscales: fatigue, mastery, and emotional function.","['Veterans with COPD', '112 US veterans (aged 70.38\u2009±\u20098.49\u2009years) with chronic obstructive pulmonary disease (COPD) who completed PR consisting of twice-weekly 2-hour classes for 18 sessions']","['Pulmonary Rehabilitation', 'Pulmonary rehabilitation (PR']","['6-Minute Walk Test (6MWT', 'CRQ-SR total score and the following subscales: fatigue, mastery, and emotional function', 'depression symptoms (Beck Depression Inventory-II [BDI-II] score', 'Chronic Respiratory Disease Questionnaire-Self Reported (CRQ-SR) and exercise capacity', 'CRQ-SR total score, subscales, and 6MWT', '6MWT distance', 'health-related quality of life (HRQoL) and exercise capacity', 'CRQ-SR fatigue', 'baseline exercise self-efficacy', 'depression']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",112.0,0.115107,"Greater reduction in depression over the course of treatment was significantly associated with greater improvement in CRQ-SR total score and the following subscales: fatigue, mastery, and emotional function.","[{'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Bamonti', 'Affiliation': 'VA New England Geriatric Research Education and Clinical Center (GRECC), VA Boston Healthcare System.'}, {'ForeName': 'Chelsea H', 'Initials': 'CH', 'LastName': 'Wiener', 'Affiliation': 'VA Boston Healthcare System.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Weiskittle', 'Affiliation': 'VA New England Geriatric Research Education and Clinical Center (GRECC), VA Boston Healthcare System.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Goodwin', 'Affiliation': 'VA Boston Healthcare System.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Silberbogen', 'Affiliation': 'VA Boston Healthcare System.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Finer', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System.'}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System.'}]","Behavioral medicine (Washington, D.C.)",['10.1080/08964289.2021.1983755']
2321,34743671,The role of exercise selection in regional Muscle Hypertrophy: A randomized controlled trial.,"There is emerging evidence suggesting that muscle growth is not homogeneous through the muscle. The aim of the present study was to analyse the role of exercise selection in regional hypertrophy. Two randomly allocated groups with equal training volume and intensity performed squats in the smith machine (SMTH group) or the leg extension exercise (LEG group). Growth in proximal, central and distal regions of the  rectus femoris  (RF) and  vastus lateralis  (VL) muscles, jump height and body composition were analysed. Results show that the three regions of RF grew significantly in the participants of the LEG group (p < 0.05), while only the central region of VL grew significantly in the SMTH group (p < 0.05). In summary, this study confirms that exercise selection plays a role in regional hypertrophy. Whilst there may be still other factors that determine how muscles grow, it seems that the chosen exercises may be responsible of the differences observed in this study.",2021,"Results show that the three regions of RF grew significantly in the participants of the LEG group (p < 0.05), while only the central region of VL grew significantly in the SMTH group (p < 0.05).",['regional Muscle Hypertrophy'],"['exercise selection', 'equal training volume and intensity performed squats in the smith machine (SMTH group) or the leg extension exercise (LEG group']","['Growth in proximal, central and distal regions of the  rectus femoris  (RF) and  vastus lateralis  (VL) muscles, jump height and body composition', 'central region of VL']","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0224444', 'cui_str': 'Structure of vastus lateralis muscle'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0454907', 'cui_str': 'Central region'}]",,0.0247907,"Results show that the three regions of RF grew significantly in the participants of the LEG group (p < 0.05), while only the central region of VL grew significantly in the SMTH group (p < 0.05).","[{'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Zabaleta-Korta', 'Affiliation': 'Department of Physical Education and Sport, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Fernández-Peña', 'Affiliation': 'Department of Physical Education and Sport, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Torres-Unda', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Garbisu-Hualde', 'Affiliation': 'Department of Physical Education and Sport, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Santos-Concejero', 'Affiliation': 'Department of Physical Education and Sport, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain.'}]",Journal of sports sciences,['10.1080/02640414.2021.1929736']
2322,34743666,Cerebral function parameters in people with HIV switching integrase inhibitors: a randomized controlled trial.,"Background:  Different antiretroviral therapies (ARTs) may have differing effects on central nervous system (CNS) function. We assessed CNS pharmacodynamic effects of switching integrase inhibitors in people-with-HIV (PWH). Methods:  PWH on tenofovir-DF/emtricitabine plus raltegravir 400 mg twice daily with suppressed plasma HIV RNA and without overt neuropsychiatric symptoms were randomly allocated on a 1:2 basis to remain on raltegravir or switch to dolutegravir 50 mg once daily for 120 days. Pharmacodynamic parameters assessed included cognitive function ( z -score of 7 domains), patient-reported outcome measures (PROMs; PHQ-9 and Beck's depression questionnaires), cerebral metabolite ratios measured by proton magnetic resonance spectroscopy (H 1 -MRS) and plasma and cerebrospinal fluid (CSF) HIV RNA. Pharmacokinetic parameters were also assessed in plasma and CSF. Changes and factors associated with changes in pharmacodynamics parameters were assessed. Results: In 20 subjects (19 male, 14 white ethnicity, median age 43 years (IQR: 11.5) and CD4 + count 717 (SD: 298) cells/µL), over 120 days there were no statistically significant changes in cognitive function [mean  z -score difference (95%CI) -0.004 (-0.38/0.37);  p  = 0.98], PROMs [PHQ-9 median score change: 0 in control arm, -0.5 switch arm ( p  = 0.57); Beck's depression questionnaire: -1.5 control arm, -1.0 switch arm ( p  = 0.38)], nor cerebral metabolite ratios between study arms. CSF HIV RNA was <5 copies/mL at baseline and day 120 in all subjects. Geometric mean pre-dose CSF dolutegravir concentration was 7.6 ng/mL (95% CI: 5.2-11.1). Conclusions: Switching integrase inhibitor in virologically suppressed PWH without overt neuropsychiatric symptoms resulted in no significant changes in an extensive panel of CNS pharmacodynamics parameters.",2021,Switching integrase inhibitor in virologically suppressed PWH without overt neuropsychiatric symptoms resulted in no significant changes in an extensive panel of CNS pharmacodynamics parameters.,"['people with HIV switching integrase inhibitors', '20 subjects (19 male, 14 white ethnicity, median age 43\u2009years (IQR: 11.5) and CD4\u2009+\u2009count 717 (SD: 298) cells/µL', 'people-with-HIV (PWH', 'and without overt neuropsychiatric symptoms']","['tenofovir-DF/emtricitabine plus raltegravir 400\u2009mg twice daily with suppressed plasma HIV RNA', 'antiretroviral therapies (ARTs']","['Cerebral function parameters', 'plasma and CSF', 'CSF HIV RNA', 'cerebral metabolite ratios', ""Beck's depression questionnaire"", 'Geometric mean pre-dose CSF dolutegravir concentration', ""cognitive function ( z -score of 7 domains), patient-reported outcome measures (PROMs; PHQ-9 and Beck's depression questionnaires), cerebral metabolite ratios measured by proton magnetic resonance spectroscopy (H 1 -MRS) and plasma and cerebrospinal fluid (CSF) HIV RNA"", 'cognitive function [mean  z -score difference (95%CI', 'CNS pharmacodynamic effects']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376601', 'cui_str': 'Integrase strand transfer inhibitor-containing product'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1967561', 'cui_str': 'raltegravir 400 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0234386', 'cui_str': 'Cerebral function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.192904,Switching integrase inhibitor in virologically suppressed PWH without overt neuropsychiatric symptoms resulted in no significant changes in an extensive panel of CNS pharmacodynamics parameters.,"[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Mora-Peris', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Keegan', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Sujan Dilly', 'Initials': 'SD', 'LastName': 'Penchala', 'Affiliation': 'Department of Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jaime H', 'Initials': 'JH', 'LastName': 'Vera', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Underwood', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Herrera', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Centre for Chemistry and Biomedicine, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Boasso', 'Affiliation': 'Centre for Immunology and Vaccinology, Imperial College London, London, UK.'}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'Department of Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Winston', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Imperial College London, London, UK.'}]",HIV research & clinical practice,[]
2323,34743663,"The Efficacy of Two Models of Intensive Upper Limb Training on Health-Related Quality of Life in Children with Hemiplegic Cerebral Palsy Mainstreamed in Regular Schools: A Double-Blinded, Randomized Controlled Trial.","BACKGROUND


Children with hemiplegic cerebral palsy (CP) are at risk of reduced upper limb function and poorer quality of life than their typically developing peers. Although upper limb impairments have potential negative impact on the health-related quality of life (HRQOL) in children with hemiplegic CP, the efficacy of upper limb rehabilitation approaches aiming to improve upper limb impairments on HRQOL has not been adequately investigated.
OBJECTIVE


This study compares the efficacy of two modes of activity-based upper limb rehabilitation (modified constraint-induced movement therapy [mCIMT] and bimanual training [BIM]) on HRQOL outcomes in children with hemiplegic CP mainstreamed in regular schools.
METHODS


Thirty children with hemiplegic CP aged between 7 and 11 years (mean age 8.53 ± 1.54 years) who had functional ability levels of I-III according to the Manual Ability Classification System (MACS), Gross Motor Classification System (GMFCS), and Communication Function Classification System (CFCS) were randomly assigned to receive mCIMT or BIM training.  Result : Both mCIMT and BIM yielded statistically significant improvements in all HRQOL domains immediately after the 10-week interventions ( P  < .001), which were retained at 16 weeks.
CONCLUSION


While there were some differences in the intervention effects, both of these upper limb rehabilitation approaches based on intensive unimanual or bimanual activity may be beneficial for improving perceived life satisfaction related to physical activity, general mood, family, friends, and school among children with hemiplegic CP mainstreamed in regular schools.",2021,"Both mCIMT and BIM yielded statistically significant improvements in all HRQOL domains immediately after the 10-week interventions ( P  < .001), which were retained at 16 weeks.
","['children with hemiplegic CP mainstreamed in regular schools', 'Children with Hemiplegic Cerebral Palsy Mainstreamed in Regular Schools', 'Children with hemiplegic cerebral palsy (CP', 'children with hemiplegic CP', 'Thirty children with hemiplegic CP aged between 7 and 11\xa0years (mean age 8.53\xa0±\xa01.54\xa0years) who had functional ability levels of I-III according to the Manual Ability Classification System (MACS), Gross Motor Classification System (GMFCS), and Communication Function Classification System (CFCS']","['activity-based upper limb rehabilitation (modified constraint-induced movement therapy [mCIMT] and bimanual training [BIM', 'Intensive Upper Limb Training', 'mCIMT or BIM training']","['HRQOL domains', 'Health-Related Quality of Life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0445450', 'cui_str': 'Bim'}, {'cui': 'C0556501', 'cui_str': 'Upper limb training'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",30.0,0.0523395,"Both mCIMT and BIM yielded statistically significant improvements in all HRQOL domains immediately after the 10-week interventions ( P  < .001), which were retained at 16 weeks.
","[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Bingol', 'Affiliation': 'Department of Therapy and Rehabilitation, Vocational School of Health Services, Mus Alparslan University, 49250-Güzeltepe/Mus, Turkey.'}, {'ForeName': 'Mintaze', 'Initials': 'M', 'LastName': 'Kerem Gunel', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Institute of Health Sciences, Hacettepe University, 06100-Samanpazarı/Ankara, Turkey.'}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Alkan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Physical Therapy and Rehabilitation, Hacettepe University, 06100-Samanpazarı/Ankara, Turkey.'}]",Physiotherapy theory and practice,['10.1080/09593985.2021.1999355']
2324,34743650,Multiple bacterial virulence factors focused on adherence and biofilm formation associate with outcomes in cirrhosis.,"BACKGROUND & AIMS


Altered gut microbiota is associated with poor outcomes in cirrhosis, including infections and hepatic encephalopathy (HE). However, the role of bacterial virulence factors (VFs) is unclear. Aim: Define association of VFs with cirrhosis severity and infections, their linkage with outcomes, and impact of fecal microbiota transplant (FMT).
METHODS


VF abundances were determined using metagenomic analysis in stools from controls and cirrhosis patients (compensated, HE-only, ascites-only, both and infected). Patients were followed for 90-day hospitalizations and 1-year death. Stool samples collected before/after a placebo-controlled FMT trial were also analyzed. Bacterial species and VFs for all species and selected pathogens ( Escherichia, Klebsiella, Pseudomonas, Staphylococcus, Streptococcus , and  Enterococcus  spp) were compared between groups. Multi-variable analyses were performed for clinical biomarkers and VFs for outcome prediction. Changes in VFs pre/post-FMT and post-FMT/placebo were analyzed.  Results : We included 233 subjects (40 controls, 43 compensated, 30 HE-only, 20 ascites-only, 70 both, and 30 infected). Decompensated patients, especially those with infections, had higher VFs coding for siderophores, biofilms, and adhesion factors versus the rest. Biofilm and adhesion VFs from  Enterobacteriaceae  and  Enterococcus  spp associated with death and hospitalizations independent of clinical factors regardless of when all VFs or selected pathogens were analyzed. FMT was associated with reduced VF post-FMT versus pre-FMT and post-placebo groups.
CONCLUSIONS


Virulence factors from multiple species focused on adhesion and biofilms increased with decompensation and infections, associated with death and hospitalizations independent of clinical factors, and were attenuated with FMT. Strategies focused on targeting multiple virulence factors could potentially impact outcomes in cirrhosis.
PRESENTATIONS


Portions of this manuscript were an oral presentation in the virtual International Liver Congress 2021.
ABBREVIATIONS


VF: virulence factors, HE: hepatic encephalopathy, FMT: Fecal microbiota transplant, PPI: proton pump inhibitors, LPS: lipopolysaccharides, VFDB: Virulence factor database, OTU: operational taxonomic units, SBP: spontaneous bacterial peritonitis, UTI: urinary tract infections, MRSA: methicillin resistant Staphylococcus aureus, VRE: vancomycin-resistant Enterococcus, MAAsLin2: Microbiome Multivariable Associations with Linear Models, LPS: lipopolysaccharides, AKI: acute kidney injury.",2021,"Decompensated patients, especially those with infections, had higher VFs coding for siderophores, biofilms, and adhesion factors versus the rest.","['233 subjects (40 controls, 43 compensated, 30 HE-only, 20 ascites-only, 70 both, and 30 infected', 'controls and cirrhosis patients (compensated, HE-only, ascites-only, both and infected', 'cirrhosis', 'Fecal microbiota transplant, PPI']","['proton pump inhibitors, LPS: lipopolysaccharides, VFDB', 'FMT', 'FMT/placebo']",['90-day hospitalizations and 1-year death'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",233.0,0.181606,"Decompensated patients, especially those with infections, had higher VFs coding for siderophores, biofilms, and adhesion factors versus the rest.","[{'ForeName': 'Jasmohan S', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and Central Virginia Veterans Healthcare System, Richmond, Virginia, USA.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Shamsaddini', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, Virginia, USA.'}, {'ForeName': 'Chathur', 'Initials': 'C', 'LastName': 'Acharya', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and Central Virginia Veterans Healthcare System, Richmond, Virginia, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fagan', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and Central Virginia Veterans Healthcare System, Richmond, Virginia, USA.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Sikaroodi', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, Virginia, USA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Gavis', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and Central Virginia Veterans Healthcare System, Richmond, Virginia, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'McGeorge', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and Central Virginia Veterans Healthcare System, Richmond, Virginia, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Khoruts', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Center for Immunology and Biotechnology Institute, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and Central Virginia Veterans Healthcare System, Richmond, Virginia, USA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Sterling', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and Central Virginia Veterans Healthcare System, Richmond, Virginia, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and Central Virginia Veterans Healthcare System, Richmond, Virginia, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Gillevet', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, Virginia, USA.'}]",Gut microbes,['10.1080/19490976.2021.1993584']
2325,34743631,Creation of a three-dimensional printed spine model for training in pain procedures.,"OBJECTIVE


Technological developments have made it possible to create simulation models to educate clinicians on surgical techniques and patient preparation. In this study, we created an inexpensive lumbar spine phantom using patient data and analyzed its usefulness in clinical education.
METHODS


This randomized comparative study used computed tomography and magnetic resonance imaging data from a single patient to print a three-dimensional (3D) bone framework and create a mold. The printed bones and structures made from the mold were placed in a simulation model that was used to train residents. The residents were divided into two groups: Group L, which received only an audiovisual lecture, and Group P, which received an additional 1 hour of training using the 3D phantom. The performance of both groups was evaluated using pretest and post-test analyses.
RESULTS


Both the checklist and global rating scores increased after training in both groups. However, some variables improved significantly only in Group P. The overall satisfaction score was also higher in Group P than in Group L.
CONCLUSIONS


We have described a method by which medical doctors can create a spine simulation phantom and have demonstrated its efficiency for procedural education.",2021,Both the checklist and global rating scores increased after training in both groups.,[],"['computed tomography and magnetic resonance imaging data', 'audiovisual lecture, and Group P, which received an additional 1 hour of training using the 3D phantom']","['overall satisfaction score', 'global rating scores']",[],"[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0162248,Both the checklist and global rating scores increased after training in both groups.,"[{'ForeName': 'Jae Chul', 'Initials': 'JC', 'LastName': 'Koh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, 37997Korea University Anam Hospital, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Yoo Kyung', 'Initials': 'YK', 'LastName': 'Jang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, 37997Korea University Anam Hospital, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Hyunyoung', 'Initials': 'H', 'LastName': 'Seong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, 37997Korea University Anam Hospital, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Kae Hong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, 37997Korea University Anam Hospital, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Seungwoo', 'Initials': 'S', 'LastName': 'Jun', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, 37997Korea University Anam Hospital, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Jong Bum', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, 65783Ajou University Hospital, Ajou University Hospital, Suwon, Korea.'}]",The Journal of international medical research,['10.1177/03000605211053281']
2326,34744069,Sling suspension therapy is an effective treatment method of juvenile spinal osteochondrosis in adolescent girls.,"BACKGROUND


Juvenile spinal osteochondrosis (JSO) affects vertebral endplates and may cause intervertebral discs alterations. The condition is typically related to pain, and weakness and shortening of trunk muscles. Sling suspension therapy (SST) has been shown to reduce lumbar pain effectively. It is, however, unclear whether SST is superior to other treatment methods in reducing pain, correcting posture, and activating trunk stabilizers in JSO.
OBJECTIVE


In this study, we intended to compare the effectiveness of two different exercise modalities; Sling Suspension Therapy and Gym Ball Exercise in the treatment of JSO in adolescent girls.
METHODS


A randomised controlled single centre clinical trial was carried out in an inpatient rehabilitation unit at a sanatorium. Forty adolescent girls (age 16.3 ± 0.47 yrs.), who were diagnosed with JSO (according to ICD-10 Version: 2016 - M 42.0) were randomly assigned into two groups: Group 1 - Sling suspension therapy (SST), Group 2 - Gym ball exercises (GBE). Both groups received interventions for 3 weeks, 15 sessions, and 30 minutes a day for 5 consecutive days a week. Back pain, endurance of trunk muscles and standing posture were evaluated pre- and post-interventions.
RESULTS


Both groups demonstrated significant improvement in all measured outcomes. SST was more effective in reducing pain (p< 0.05), increasing the endurance of trunk muscles (p< 0.05) and improving the standing posture (p< 0.05) compared to GBE (p< 0.05).
CONCLUSIONS


Sling suspension therapy is more effective compared with Gym ball exercises in the treatment of juvenile spinal osteochondrosis in adolescent girls in terms of back pain, posture and endurance of trunk muscles.",2021,"SST was more effective in reducing pain (p< 0.05), increasing the endurance of trunk muscles (p< 0.05) and improving the standing posture (p< 0.05) compared to GBE (p< 0.05).
","['Forty adolescent girls (age 16.3 ± 0.47 yrs.), who were diagnosed with JSO (according to ICD-10 Version: 2016 - M 42.0', 'inpatient rehabilitation unit at a sanatorium', 'adolescent girls']","['SST', 'Group 1 - Sling suspension therapy (SST), Group 2 - Gym ball exercises (GBE', 'Sling suspension therapy', 'exercise modalities; Sling Suspension Therapy and Gym Ball Exercise', 'Sling suspension therapy (SST', 'Gym ball exercises']","['pain', 'standing posture', 'endurance of trunk muscles', 'Back pain, endurance of trunk muscles and standing posture']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0036310', 'cui_str': 'Juvenile osteochondrosis of spine'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0183346', 'cui_str': 'Sling'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",40.0,0.0327371,"SST was more effective in reducing pain (p< 0.05), increasing the endurance of trunk muscles (p< 0.05) and improving the standing posture (p< 0.05) compared to GBE (p< 0.05).
","[{'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Dudoniene', 'Affiliation': 'Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Raija', 'Initials': 'R', 'LastName': 'Kuisma', 'Affiliation': 'Karelia University of Applied Sciences, Joensuu, Finland.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Juodzbaliene', 'Affiliation': 'Lithuanian Sports University, Kaunas, Lithuania.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-210099']
2327,34656188,Comparing Traditional and Ebook-Augmented Parent-Child Interaction Therapy (PCIT): A Randomized Control Trial of Pocket PCIT.,"Disruptive behavior in young children is one of the most common referrals to behavioral health providers. While numerous effective parenting programs, such as parent-child interaction therapy (PCIT), exist for improving children's behaviors, challenges with treatment engagement and retention limit the intended positive impact on child and caregiver outcomes, particularly for racial and ethnic minority families. In an effort to address barriers contributing to poor engagement and retention in traditional PCIT service delivery and among ethnic and racial minority families, a multimedia PCIT ebook was developed and evaluated. In a sample of the general public that utilized the ebook, users were found to be more engaged in viewing embedded videos within the ebook that were related to expert skill explanations and skill demonstrations than caregiver testimonies. A randomized controlled trial was also conducted to evaluate the extent that the ebook + PCIT improved treatment engagement, retention, parenting skills, skill acquisition efficiency, and child behavior above and beyond traditional PCIT. Participating families were randomly assigned to either the traditional PCIT (n = 71) or ebook + PCIT (n = 107) group using an online random number generator. Forty-nine caregivers (traditional PCIT n = 24, ebook + PCIT n = 25) were excluded from analyses because they were lost to follow-up during the intervention. Families in both the traditional PCIT and ebook + PCIT groups demonstrated generally equivalent positive outcomes in treatment engagement (i.e., attendance, treatment length, completion rate) and caregiver skill acquisition efficiency at midtreatment, posttreatment, and 3-month follow-up. The addition of the ebook to PCIT also reduced child disruptive behavior at midtreatment, above and beyond traditional PCIT, but not at posttreatment or follow-up. Clinical implications and future directions are discussed.",2021,"Families in both the traditional PCIT and ebook + PCIT groups demonstrated generally equivalent positive outcomes in treatment engagement (i.e., attendance, treatment length, completion rate) and caregiver skill acquisition efficiency at midtreatment, posttreatment, and 3-month follow-up.","['young children', 'Participating families', 'Forty-nine caregivers (traditional PCIT n\u202f=\u202f24, ebook\u202f+\u202fPCIT n\u202f=\u202f25']","['ebook\u202f+\u202fPCIT', 'Traditional and Ebook-Augmented Parent-Child Interaction Therapy (PCIT', 'traditional PCIT (n\u202f=\u202f71) or ebook\u202f+\u202fPCIT (n\u202f=\u202f107) group using an online random number generator']","['equivalent positive outcomes in treatment engagement (i.e., attendance, treatment length, completion rate) and caregiver skill acquisition efficiency', 'child disruptive behavior', 'Disruptive behavior', 'treatment engagement, retention, parenting skills, skill acquisition efficiency, and child behavior above and beyond traditional PCIT']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0237638', 'cui_str': 'Generator'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",25.0,0.0552316,"Families in both the traditional PCIT and ebook + PCIT groups demonstrated generally equivalent positive outcomes in treatment engagement (i.e., attendance, treatment length, completion rate) and caregiver skill acquisition efficiency at midtreatment, posttreatment, and 3-month follow-up.","[{'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Jent', 'Affiliation': 'University of Miami. Electronic address: jjent@med.miami.edu.'}, {'ForeName': 'W Andrew', 'Initials': 'WA', 'LastName': 'Rothenberg', 'Affiliation': 'University of Miami; Duke University Center for Child and Family Policy.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Weinstein', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Stokes', 'Affiliation': 'West Virginia University.'}, {'ForeName': 'Miya', 'Initials': 'M', 'LastName': 'Barnett', 'Affiliation': 'University of California-Santa Barbara.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Srivatsa', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Dandes', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Dainelys', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': 'University of Miami.'}]",Behavior therapy,['10.1016/j.beth.2021.02.013']
2328,34740927,Perceptions of ASHA workers in the HOPE collaborative care mental health intervention in rural South India: a qualitative analysis.,"OBJECTIVE


The main objective of this exploratory study was to investigate the overlooked perspectives and beliefs of Accredited Social Health Activists (ASHA workers) regarding a collaborative care mental health intervention (HOPE:  H ealthier  Op tions through  E mpowerment), mental illness and the health of their rural communities.
DESIGN


Semi-structured, one-on-one, qualitative interviews.
SETTING


Seven primary health centres (PHCs) in rural Karnataka, India. All PHCs had previously completed the HOPE study.
PARTICIPANTS


15 ASHA workers, selected via purposive sampling. ASHAs are high school-educated village women trained as community health workers. ASHAs were included if they had previously participated in the HOPE intervention, a collaborative-care randomised controlled trial that aimed to integrate mental healthcare into existing primary care systems in rural Karnataka.
INTERVENTIONS


No interventions were introduced.
RESULTS


ASHA workers mostly had positive interactions with patients, including encouraging them to attend sessions, helping to explain the topics and techniques, and checking on the patients frequently. ASHA workers were able to identify key barriers to treatment and facilitators to treatment. ASHAs claimed that their knowledge about mental illness improved because of the HOPE study, though gaps remained in their understanding of aetiology and treatment. Several expressed interest in receiving additional mental health training. Overall, ASHAs viewed the HOPE study as a necessary and effective intervention, and requested that it expand.
CONCLUSIONS


This paper discusses the perspectives of ASHAs who participated in a novel effort to extend the collaborative care model to their own communities. ASHA workers help maintain relationships with patients that encourage participation, and the efforts of ASHAs often aid in mitigating common barriers to treatment. ASHA workers' beliefs and knowledge regarding mental illness can be changed, and ASHAs can become effective advocates for patients. Future collaborative care interventions would likely benefit from involving ASHA workers in community outreach efforts.",2021,"ASHA workers' beliefs and knowledge regarding mental illness can be changed, and ASHAs can become effective advocates for patients.","['Seven primary health centres (PHCs) in rural Karnataka, India', 'rural South India', '15 ASHA workers, selected via purposive sampling']",['mental healthcare into existing primary care systems in rural Karnataka'],[],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",[],15.0,0.0282481,"ASHA workers' beliefs and knowledge regarding mental illness can be changed, and ASHAs can become effective advocates for patients.","[{'ForeName': 'Stuti', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Molecular and Cellular Biology, University of California Berkeley, Berkeley, California, USA sbansal@berkeley.edu.'}, {'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health & Neurosciences, St John's Research Institute, Bangalore, Karnataka, India.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ekstrand', 'Affiliation': ""Division of Mental Health & Neurosciences, St John's Research Institute, Bangalore, Karnataka, India.""}]",BMJ open,['10.1136/bmjopen-2020-047365']
2329,34741240,The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience.,"Pandemic restrictions have led to changes in therapy plans and disrupted rehabilitation services for people with multiple sclerosis. CogEx is an international, multicentre MS dual-intervention (cognitive rehabilitation, aerobic exercise) randomized, controlled rehabilitation trial confined to people with progressive disease. The primary outcome is cognition (processing speed).There are 11 treatment sites in six countries with participants required to make 27 site visits over 12 weeks. Collectively, the large, in-person demands of the trial, and the varying international policies for the containment of COVID-19, might disproportionately impact the administration of CogEx. During the first lockdown, all centres closed on average for 82.9 (SD = 24.3) days. One site was required to lockdown on two further occasions. One site remained closed for 16 months. Ten staff (19.2%) were required to quarantine and eight staff (15.4%) tested positive for COVID. 10 of 264 (3.8%) participants acquired COVID-19. All survived. The mean duration of enrollment delay has been [236.7 (SD = 214.5) days]. Restarting participants whose interventions were interrupted by the pandemic meant recalculating the intervention prescriptions for these individuals. While the impact of the pandemic on CogEx has been considerable, all study sites are again open. Participants and staff have shown considerable flexibility and resilience in keeping a complex, international endeavour running. The future in general remains uncertain in the midst of a pandemic, but there is cautious optimism the study will be completed with sufficient sample size to robustly evaluate our hypothesis and provide meaningful results to the MS community on the impact of these interventions on people with progressive MS.Trial registration: The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated.",2021,"During the first lockdown, all centres closed on average for 82.9 (SD = 24.3) days.","['people with progressive disease', 'people with multiple sclerosis']",[],"['cognition (processing speed).There are 11 treatment sites in six countries with participants required to make 27 site visits', 'mean duration of enrollment delay']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]",[],"[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]",,0.250936,"During the first lockdown, all centres closed on average for 82.9 (SD = 24.3) days.","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Feinstein', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada. ant.feinstein@utoronto.ca.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Amato', 'Affiliation': 'Department NEUROFARBA, Section Neurosciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Brichetto', 'Affiliation': 'Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Via Operai 40, 16149, Genoa, Italy.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Chataway', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, Faculty of Brain Sciences, UCL Queen Square Institute of Neurology, University College London, London, WC1B 5EH, UK.'}, {'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Chiaravalloti', 'Affiliation': 'Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000, Aarhus, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Farrell', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, Faculty of Brain Sciences, UCL Queen Square Institute of Neurology, University College London, London, WC1B 5EH, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'REVAL. Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Filippi', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, IRCSS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Faculty of Health, School of Health Professions, University of Plymouth, Devon, UK.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Inglese', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, and Center of Excellence for Biomedical Research, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Meza', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Maria Assunta', 'Initials': 'MA', 'LastName': 'Rocca', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, IRCSS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Department of Neurology, Section on Statistical Planning and Analysis, UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-021-10881-3']
2330,34741102,Safety of sildenafil in extremely premature infants: a phase I trial.,"OBJECTIVE


To characterize the safety of sildenafil in premature infants.
STUDY DESIGN


A phase I, open-label trial of sildenafil in premature infants receiving sildenafil per usual clinical care (cohort 1) or receiving a single IV dose of sildenafil (cohort 2). Safety was evaluated based on adverse events (AEs), transaminase levels, and mean arterial pressure monitoring.
RESULTS


Twenty-four infants in cohort 1 (n = 25) received enteral sildenafil. In cohort 2, infants received a single IV sildenafil dose of 0.25 mg/kg (n = 7) or 0.125 mg/kg (n = 2). In cohort 2, there was one serious AE related to study drug involving hypotension associated with a faster infusion rate than specified by the protocol. There were no AEs related to elevated transaminases.
CONCLUSION


Sildenafil was well tolerated by the study population. Drug administration times and flush rates require careful attention to prevent infusion-related hypotension associated with faster infusions of IV sildenafil in premature infants.
CLINICAL TRIAL


ClinicalTrials.gov Identifier: NCT01670136.",2021,"There were no AEs related to elevated transaminases.
","['premature infants', 'extremely premature infants', 'premature infants receiving sildenafil per usual clinical care (cohort 1) or receiving a single IV dose of']","['Sildenafil', 'sildenafil', 'single IV sildenafil', 'enteral sildenafil']","['adverse events (AEs), transaminase levels, and mean arterial pressure monitoring']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",,0.254866,"There were no AEs related to elevated transaminases.
","[{'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Jackson', 'Affiliation': 'Department of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. wesley.jackson@unc.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'P Brian', 'Initials': 'PB', 'LastName': 'Smith', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Division of Neonatology, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': ""Department of Pediatrics, Medical University of South Carolina Children's Hospital, Charleston, SC, USA.""}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Sokol', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Chi D', 'Initials': 'CD', 'LastName': 'Hornik', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Stewart', 'Affiliation': ""University of Louisville Norton Children's Hospital, Louisville, KY, USA.""}, {'ForeName': 'Gratias', 'Initials': 'G', 'LastName': 'Mundakel', 'Affiliation': 'Kings County Hospital Center/SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Brenda B', 'Initials': 'BB', 'LastName': 'Poindexter', 'Affiliation': ""Department of Pediatrics, Emory University and Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Shawn K', 'Initials': 'SK', 'LastName': 'Ahlfeld', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Mills', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Martz', 'Affiliation': 'The Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Laughon', 'Affiliation': 'Department of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-021-01261-w']
2331,34741088,Acute objective and subjective intoxication effects of legal-market high potency THC-dominant versus CBD-dominant cannabis concentrates.,"As the market for cannabis concentrate products grows, the lack of research regarding the effects of concentrated THC and CBD becomes more glaring. The present study analyzes cannabinoid blood levels and subjective outcomes of physical sensation and affective state after ad libitum use of legal-market concentrate products. Recreational cannabis users were randomly assigned to THC- or CBD-dominant concentrate products, completing a baseline session, and an experimental mobile laboratory session consisting of timepoints before, immediately after, and one-hour after concentrate use. THC-dominant concentrates induced higher intoxication, and higher ratings of drug effect and drug liking than the CBD-dominant concentrate. Both products induced immediate feelings of elation, diminishing over the subsequent hour. Subjective outcomes in the CBD-dominant group revealed immediate decreases in tension and anxiety relative to pre-use, while the THC-dominant group only saw significant decreases in anxiety after one hour. Paranoia spiked immediately post-use in THC-dominant concentrate users, returning to baseline within an hour. Overall, the CBD-dominant concentrate invoked positive mood effects, lower intoxication and an absence of undesirable effects experienced with the THC-dominant concentrate, potentially mitigating negative effects when combined. Results support the need for further investigation into harm-reduction potential of concentrated CBD when used alone and with THC.",2021,"THC-dominant concentrates induced higher intoxication, and higher ratings of drug effect and drug liking than the CBD-dominant concentrate.",['Recreational cannabis users'],"['THC- or CBD-dominant concentrate products, completing a baseline session', 'legal-market high potency THC-dominant versus CBD-dominant cannabis concentrates']","['anxiety', 'tension and anxiety', 'higher ratings of drug effect and drug liking']","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0220653,"THC-dominant concentrates induced higher intoxication, and higher ratings of drug effect and drug liking than the CBD-dominant concentrate.","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Drennan', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, 80525, USA. megganla@colostate.edu.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Karoly', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, 80525, USA.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Hutchison', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Bidwell', 'Affiliation': 'Institute of Cognitive Science, University of Colorado Boulder, Boulder, CO, 80309, USA.'}]",Scientific reports,['10.1038/s41598-021-01128-2']
2332,34657387,Combining liquid biopsy and functional imaging analysis in metastatic castration-resistant prostate cancer helps predict treatment outcome.,"Plasma tumour DNA (ptDNA) is a potential early noninvasive biomarker of treatment outcome in metastatic castration-resistant prostate cancer (mCRPC). Herein, we investigated whether pretreatment ptDNA levels reflect metabolic tumour burden in mCRPC and better predict treatment outcome in combination with functional imaging. Targeted next-generation sequencing was performed to estimate the ptDNA fraction from 102 mCRPC patients receiving abiraterone or enzalutamide. The maximum standardized uptake value (SUVmax), total lesion activity (TLA) and metabolic tumour volume (MTV) were evaluated on  18  F-fluorocholine positron emission tomography/computed tomography. We assessed a Weibull multiple regression model to determine the combined impact of clinical, molecular and imaging characteristics on overall survival (OS) and progression-free survival (PFS), and to obtain prognostic scores. A significant association was seen between ptDNA and SUVmax, MTV and TLA. For survival analysis, patients were randomly allocated into a training (n = 68) and a validation (n = 34) set. In the training set, multivariable analyses showed that ptDNA, MTV and serum lactate dehydrogenase together with visceral metastasis were independent predictors of both OS and PFS. Prognostic scores were generated, with the identification of three groups of patients with significantly different median OS (29.2, 15.9 and 8.7 months) and PFS (13.3, 7.7 and 3.2 months) probabilities. The differences in median survival between risk groups were confirmed in the validation cohort for both OS and PFS. In our study, we showed that integrating plasma DNA analysis with functional imaging may improve prognostic risk stratification and treatment selection in mCRPC.",2021,Plasma tumour DNA (ptDNA) is a potential early non-invasive biomarker of treatment outcome in metastatic castration-resistant prostate cancer (mCRPC).,"['102 mCRPC patients receiving', 'metastatic castration-resistant prostate cancer', 'metastatic castration-resistant prostate cancer (mCRPC']",['abiraterone or enzalutamide'],"['ptDNA, MTV and serum lactate dehydrogenase (LDH) together with visceral metastasis', 'overall survival (OS) and progression-free survival (PFS', 'PFS', 'median survival', 'maximum standardized uptake value (SUVmax), total lesion activity (TLA) and metabolic tumour volume (MTV', 'median OS', 'Prognostic scores']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449821', 'cui_str': 'Prognostic score'}]",,0.0799662,Plasma tumour DNA (ptDNA) is a potential early non-invasive biomarker of treatment outcome in metastatic castration-resistant prostate cancer (mCRPC).,"[{'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Conteduca', 'Affiliation': 'Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Scarpi', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Caroli', 'Affiliation': 'Nuclear Medicine Operative Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Lolli', 'Affiliation': 'Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Gurioli', 'Affiliation': 'Biosciences Laboratory, IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Brighi', 'Affiliation': 'Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Poti', 'Affiliation': ""Istituto Dermopatico dell'Immacolata, IDI-IRCCS, Rome, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Farolfi', 'Affiliation': 'Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Altavilla', 'Affiliation': 'Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Schepisi', 'Affiliation': 'Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Matteucci', 'Affiliation': 'Nuclear Medicine Operative Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Paganelli', 'Affiliation': 'Nuclear Medicine Operative Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}]",Molecular oncology,['10.1002/1878-0261.13120']
2333,34657367,"Open vs robot-assisted radical cystectomy (BORARC): a double-blinded, randomised feasibility study.","OBJECTIVE


To examine surgical outcomes and feasibility of blinding patients and care providers to the surgical technique of radical cystectomy (RC).
PATIENTS AND METHODS


Single-centre, parallel-group, double-blinded, randomised feasibility study of open RC (ORC) vs robot-assisted RC with intracorporeal urinary diversion (iRARC) in an 'Enhanced Recovery After Surgery' setup. A total of 50 patients aged ≥18 years with bladder cancer planned for RC with an ileal conduit were included. Patients with previous major abdominal/pelvic surgery, pelvic radiation or anaesthesiological contraindications were excluded. Primary outcomes were proportion of unblinded patients and success of blinding using Bang's Blinding Index. Secondary outcomes included length of stay (LOS), complication rates, blood loss, pain, and opioid consumption.
RESULTS


A total of 26% of the patients were unblinded before discharge. We demonstrated that patients and doctors remained blinded for the allocated treatment, but nurses did not. Blood loss was greater in the ORC group as was operative time in the iRARC group. We found no difference in complication rate, LOS, or use of analgesics.
CONCLUSIONS


The present study demonstrates that blinding of surgical technique in RC is possible. The results of secondary outcomes are consistent with the findings of previous unblinded randomised controlled trials. Our study highlights that it is possible to perform a blinded phase III study to explore the optimal surgical technique in RC.",2021,Blood loss was greater in the ORC group as was operative time in the iRARC group.,"['50 patients ≥18 years with bladder cancer planned for RC with an ileal conduit were included', 'Patients with previous major abdominal/pelvic surgery, pelvic radiation or anesthesiological contraindications were excluded']","['open RC versus robot-assisted RC with intracorporeal urinary diversion in an ERAS setup', 'Open vs robot-assisted radical cystectomy (BORARC']","['operative time', ""proportion of unblinded patients and success of blinding using Bang's Blinding Index (BI"", 'length of stay (LOS), complication rates, blood loss, pain and opioid consumption', 'complication rate, LOS or use of analgesics', 'Blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0348002', 'cui_str': 'Ileal Conduit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0042020', 'cui_str': 'Urinary diversion procedure'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0302363', 'cui_str': 'Infection due to Brucella abortus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",50.0,0.425558,Blood loss was greater in the ORC group as was operative time in the iRARC group.,"[{'ForeName': 'Sophia L', 'Initials': 'SL', 'LastName': 'Maibom', 'Affiliation': 'Urological Research Unit, Department of Urology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Røder', 'Affiliation': 'Urological Research Unit, Department of Urology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Eske K', 'Initials': 'EK', 'LastName': 'Aasvang', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Malene', 'Initials': 'M', 'LastName': 'Rohrsted', 'Affiliation': 'Department of Urology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter O', 'Initials': 'PO', 'LastName': 'Thind', 'Affiliation': 'Department of Urology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Bagi', 'Affiliation': 'Department of Urology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kistorp', 'Affiliation': 'Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Urology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lisbeth N', 'Initials': 'LN', 'LastName': 'Salling', 'Affiliation': 'Department of Urology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Brasso', 'Affiliation': 'Urological Research Unit, Department of Urology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ulla N', 'Initials': 'UN', 'LastName': 'Joensen', 'Affiliation': 'Urological Research Unit, Department of Urology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}]",BJU international,['10.1111/bju.15619']
2334,34656378,"Safety and immunogenicity of a multidose vial formulation of 13-valent pneumococcal conjugate vaccine administered with routine pediatric vaccines in healthy infants in India: A phase 4, randomized, open-label study.","PURPOSE


This phase 4, randomized, open-label, multicenter study in healthy Indian infants and toddlers evaluated the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) formulated in a multidose vial (MDV) or single prefilled syringe (PFS).
METHODS


Healthy Indian infants (6 weeks of age) were randomized 1:1 to receive either PCV13-MDV or PCV13-PFS concomitant with routine pediatric vaccines. Subjects received a single dose of either PCV13-MDV or PCV13-PFS as a 4-dose schedule (infant series: 1 dose at 6, 10, and 14 weeks of age; toddler dose: 12 months of age). Safety was assessed, including local reactions, systemic events, and adverse events (AEs). Immunogenicity 1 month after both the infant series and toddler dose was measured by concentrations of serotype-specific immunoglobulin G (IgG) antibodies and opsonophagocytic activity titers.
RESULTS


Rates and severities of local reactions and systemic events up to 7 days after each dose of either PCV13-MDV or PCV13-PFS were generally similar, with the majority being of mild or moderate severity. PCV13-MDV had a safety profile comparable with PCV13-PFS; both groups experienced a similar frequency of AEs. PCV13-MDV elicited immune responses comparable with those induced by PCV13-PFS. Clear boosting of immune responses after the PCV13-MDV toddler dose was observed; ≥96% of subjects showed serotype-specific IgG concentrations at or above the defined thresholds 1 month after the PCV13-MDV toddler dose.
CONCLUSIONS


PCV13-MDV was safe, well tolerated, and immunogenic in healthy Indian infants and toddlers when coadministered with routine pediatric vaccinations. Safety and immunogenicity of PCV13-MDV was comparable with PCV13-PFS.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov: NCT03548337.",2021,"RESULTS


Rates and severities of local reactions and systemic events up to 7 days after each dose of either PCV13-MDV or PCV13-PFS were generally similar, with the majority being of mild or moderate severity.","['healthy infants in India', 'healthy Indian infants and toddlers', 'Healthy Indian infants (6\xa0weeks of age']","['PCV13-MDV or PCV13-PFS concomitant with routine pediatric vaccines', 'PCV13-MDV or PCV13-PFS', 'PCV13-PFS', '13-valent pneumococcal conjugate vaccine (PCV13) formulated in a multidose vial (MDV) or single prefilled syringe (PFS', 'PCV13-MDV']","['local reactions, systemic events, and adverse events (AEs', 'safe, well tolerated, and immunogenic', 'PCV13-MDV elicited immune responses', 'serotype-specific IgG concentrations', 'Safety and immunogenicity', 'Rates and severities of local reactions and systemic events', 'safety, tolerability, and immunogenicity', 'Safety and immunogenicity of PCV13-MDV', 'concentrations of serotype-specific immunoglobulin G (IgG) antibodies and opsonophagocytic activity titers']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1706398', 'cui_str': 'Vial - unit of product usage'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1706398', 'cui_str': 'Vial - unit of product usage'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.0555611,"RESULTS


Rates and severities of local reactions and systemic events up to 7 days after each dose of either PCV13-MDV or PCV13-PFS were generally similar, with the majority being of mild or moderate severity.","[{'ForeName': 'Sanjay Kewalchand', 'Initials': 'SK', 'LastName': 'Lalwani', 'Affiliation': 'Department of Pediatrics, Bharati Vidyapeeth Medical College and Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Padmasani Venkat', 'Initials': 'PV', 'LastName': 'Ramanan', 'Affiliation': 'Department of Pediatrics, Sri Ramachandra Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Sapru', 'Affiliation': 'Department of Pediatrics, KEM Hospital Research Centre, Pune, Maharashtra, India.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Sundaram', 'Affiliation': 'Department of Pediatrics, Kanchi Kamakoti CHILDS Trust Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Bela Hasmukh', 'Initials': 'BH', 'LastName': 'Shah', 'Affiliation': 'Department of Pediatrics, B.J. Medical College and Civil Hospital, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kaul', 'Affiliation': 'Department of Pediatrics, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Karthik Nagesh', 'Affiliation': 'Department of Pediatrics, Manipal Hospital, Bengaluru, Karnataka, India.'}, {'ForeName': 'Warren V', 'Initials': 'WV', 'LastName': 'Kalina', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Chand', 'Affiliation': 'Global Site and Study Operations, Pfizer Ltd, Mumbai, India.'}, {'ForeName': 'Meichun', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Suroju', 'Affiliation': 'Vaccine Clinical Research and Development, Pfizer Ltd, Hurley, UK.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Scott', 'Affiliation': 'Vaccine Clinical Research and Development, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Lockhart', 'Affiliation': 'Vaccine Clinical Research and Development, Pfizer Ltd, Hurley, UK. Electronic address: stephen.p.lockhart@pfizer.com.'}]",Vaccine,['10.1016/j.vaccine.2021.09.029']
2335,34661885,Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2.,"INTRODUCTION


Psoriatic arthritis (PsA) has a major impact on health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), important components in the assessment of therapeutic efficacy. We evaluated the impact of upadacitinib on PROs in PsA patients with inadequate responses or intolerance to biologic disease-modifying anti-rheumatic drugs (bDMARD-IR).
METHODS


Patients enrolled in the phase 3 SELECT-PsA 2 randomized controlled trial (RCT) received 56 weeks of oral upadacitinib 15 mg QD, upadacitinib 30 mg QD, or placebo switched to either dose of upadacitinib at week 24. PROs included patient global assessment of disease activity (PtGA), pain, physical function (HAQ-DI), health-related quality of life (SF-36 physical (PCS) and mental (MCS) component summary and domain scores), fatigue (FACIT-F), psoriasis symptom severity (SAPS), and work productivity (WPAI). Mean changes from baseline in PROs, improvements ≥ minimum clinically important differences (MCID) and scores ≥ normative values, and maintenance of improvements were assessed.
RESULTS


At weeks 12 and 24, patients treated with either upadacitinib dose reported statistically and nominally significant improvements from baseline across all PROs versus placebo (p ≤ 0.05), except the WPAI absenteeism domain, which were maintained or further improved to week 56. A significantly greater proportion of patients receiving either upadacitinib dose reported improvements ≥ MCID and scores ≥ normative values versus placebo (nominal p ≤ 0.01) in most PROs at weeks 12 and 24, with clinically meaningful improvements continuing to week 56. Improvements ≥ MCID were reported as early as week 2 in PtGA, pain, and HAQ-DI.
CONCLUSIONS


Upadacitinib provides rapid, clinically meaningful, and sustained improvements in PROs reported by bDMARD-IR PsA patients. SELECT-PsA 2 ClinicalTrials.gov number, NCT03104374.",2021,"A significantly greater proportion of patients receiving either upadacitinib dose reported improvements ≥ MCID and scores ≥ normative values versus placebo (nominal p ≤ 0.01) in most PROs at weeks 12 and 24, with clinically meaningful improvements continuing to week 56.","['PsA patients with inadequate responses or intolerance to biologic disease-modifying anti-rheumatic drugs (bDMARD-IR', 'Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs', 'Patients enrolled in the phase 3 SELECT-PsA 2 randomized controlled trial (RCT']","['placebo', 'oral upadacitinib 15\xa0mg QD, upadacitinib 30\xa0mg QD, or placebo']","['Improvements\u2009≥\u2009MCID', 'PROs, improvements\u2009≥\u2009minimum clinically important differences (MCID) and scores\u2009≥\u2009normative values, and maintenance of improvements', 'patient global assessment of disease activity (PtGA), pain, physical function (HAQ-DI), health-related quality of life (SF-36 physical (PCS) and mental (MCS) component summary and domain scores), fatigue (FACIT-F), psoriasis symptom severity (SAPS), and work productivity (WPAI', 'improvements\u2009≥\u2009MCID and scores\u2009≥\u2009normative values']","[{'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C5196293', 'cui_str': 'upadacitinib 15 MG [Rinvoq]'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.276256,"A significantly greater proportion of patients receiving either upadacitinib dose reported improvements ≥ MCID and scores ≥ normative values versus placebo (nominal p ≤ 0.01) in most PROs at weeks 12 and 24, with clinically meaningful improvements continuing to week 56.","[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Van den Bosch', 'Affiliation': 'Department of Internal Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ranza', 'Affiliation': 'Rheumatology Unit, Hospital de Clinicas, Universidade Federal de Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Leung', 'Affiliation': 'Department of Rheumatology and Immunology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Drescher', 'Affiliation': 'Department of Rheumatology, Csolnoky Ferenc County Hospital/Vital Medical Center Private Clinic, Veszprém, Hungary.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Zueger', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA. patrick.zueger@abbvie.com.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Saffore', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Apinya', 'Initials': 'A', 'LastName': 'Lertratanakul', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Lippe', 'Affiliation': 'AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Department of Medicine, Griffith University, Brisbane, QLD, Australia.'}]",Rheumatology and therapy,['10.1007/s40744-021-00377-x']
2336,34664616,Systemic autoimmune myopathies: A prospective phase 4 controlled trial of an inactivated virus vaccine against SARS-CoV-2.,"OBJECTIVES


To evaluate immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in systemic autoimmune myopathies (SAMs) and the possible influence of baseline disease parameters, comorbidities, and therapy on immune response.
METHODS


This prospective controlled study included 53 patients with SAMs and 106 non-immunocompromised control group (CTRL). All participants received two doses of the Sinovac-CoronaVac vaccine (28-day interval). Immunogenicity was assessed by anti-SARS-CoV-2 S1/S2 IgG seroconversion (SC), anti-S1/S2 IgG geometric mean titer (GMT), factor increase GMT (FI-GMT), neutralizing antibodies (NAb) positivity, and median neutralizing activity after each vaccine dose (D0 and D28) and six weeks after the second dose (D69). Participants with pre-vaccination positive IgG serology and/or NAb and those with RT-PCR confirmed COVID-19 during the protocol were excluded from immunogenicity analysis.
RESULTS


Patients and CTRL had comparable sex (P>0.99) and age (P=0.90). Immunogenicity of 37 patients and 79 CTRL naïve participants revealed at D69, a moderate but significantly lower SC (64.9% vs. 91.1%, P<0.001), GMT [7.9 (95%CI 4.7-13.2) vs. 24.7 (95%CI 30.0-30.5) UA/mL, P<0.001] and frequency of NAb (51.4% vs. 77.2%, P<0.001) in SAMs compared to CTRL. Median neutralizing activity was comparable in both groups [57.2% (IQR 43.4-83.4) vs. 63.0% (IQR 40.3-80.7), P=0.808]. Immunosuppressives were less frequently used among NAb+ patients vs. NAb- patients (73.7% vs. 100%, P=0.046). Type of SAMs, disease status, other drugs or comorbidities did not influence immunogenicity. Vaccine-related adverse events were mild with similar frequencies in patients and CTRL (P>0.05).
CONCLUSION


Sinovac-CoronaVac is safe and has a moderate short-term immunogenicity in SAMs, but reduced compared to CTRL. We further identified that immunosuppression is associated with diminished NAb positivity.
CLINICAL TRIAL REGISTRATION NUMBER


#NCT04754698.",2021,"Median neutralizing activity was comparable in both groups [57.2% (IQR 43.4-83.4) vs. 63.0% (IQR 40.3-80.7), P=0.808].","['Participants with pre-vaccination positive IgG serology and/or NAb and those with RT-PCR confirmed COVID-19 during the protocol were excluded from immunogenicity analysis', '37 patients and 79 CTRL naïve participants', '53 patients with SAMs and 106 non-immunocompromised control group (CTRL']","['inactivated SARS-CoV-2 vaccine', 'Sinovac-CoronaVac vaccine']","['Median neutralizing activity', 'frequency of NAb', 'Immunosuppressives', 'anti-SARS-CoV-2 S1/S2 IgG seroconversion (SC), anti-S1/S2 IgG geometric mean titer (GMT), factor increase GMT (FI-GMT), neutralizing antibodies (NAb) positivity, and median neutralizing activity', 'Immunogenicity']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C4302167', 'cui_str': 'Autoimmune myopathy'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",53.0,0.191028,"Median neutralizing activity was comparable in both groups [57.2% (IQR 43.4-83.4) vs. 63.0% (IQR 40.3-80.7), P=0.808].","[{'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Shinjo', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Fernando H C', 'Initials': 'FHC', 'LastName': 'de Souza', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Isabela B P', 'Initials': 'IBP', 'LastName': 'Borges', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Alexandre M', 'Initials': 'AM', 'LastName': 'Dos Santos', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Miossi', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Rafael G', 'Initials': 'RG', 'LastName': 'Misse', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Medeiros-Ribeiro', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Carla G S', 'Initials': 'CGS', 'LastName': 'Saad', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Emily F N', 'Initials': 'EFN', 'LastName': 'Yuki', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Sandra G', 'Initials': 'SG', 'LastName': 'Pasoto', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Léonard V K', 'Initials': 'LVK', 'LastName': 'Kupa', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Ceneviva', 'Affiliation': 'Central Laboratory Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Júlia C', 'Initials': 'JC', 'LastName': 'Seraphim', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Tatiana N', 'Initials': 'TN', 'LastName': 'Pedrosa', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Margarete B G', 'Initials': 'MBG', 'LastName': 'Vendramini', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Clóvis A', 'Initials': 'CA', 'LastName': 'Silva', 'Affiliation': ""Pediatric Rheumatology Unit, Childrens' Institute, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).""}, {'ForeName': 'Nádia E', 'Initials': 'NE', 'LastName': 'Aikawa', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Bonfá', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil (BR).'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keab773']
2337,34662548,A pilot and open trial to evaluate topical Bacterial Cellulose bio-curatives in the treatment of cutaneous leishmaniasis caused by L. braziliensis.,"The treatment of cutaneous leishmaniasis (CL) in Brazil using pentavalent antimony (Sb v ) is associated with a high failure rate and long time to heal. Moreover, standard Sb v  treatment cures only 50-60% of the cases. In this pilot clinical trial, we evaluated the topical use of bacterial cellulose (BC) bio-curatives + Sb v  in the treatment of CL caused by L. braziliensis, in Bahia, Brazil. A total of 20 patients were randomized in two groups assigned to receive either parenteral Sb v  alone or parenteral Sb v  plus topically applied BC bio-curatives. CL patients treated with Sb v  + topical BC bio-curatives had a significantly higher cure rate at 60 days post initiation of treatment compared to CL patients treated with Sb v  alone (P=0.01). At day 90 post initiation of treatment, cure rate was similar in the two groups as was overall healing time. Adverse effects or local reactions to topical BC application were not observed. This pilot trial shows that the potential use of a combined therapy consisting of topical BC bio-curatives and parenteral Sb v  in favoring healing of CL lesions caused by L. braziliensis, at an early time point.",2021,CL patients treated with Sb v  + topical BC bio-curatives had a significantly higher cure rate at 60 days post initiation of treatment compared to CL patients treated with Sb v  alone (P=0.01).,"['A total of 20 patients', 'cutaneous leishmaniasis caused by L. braziliensis']","['bacterial cellulose (BC) bio-curatives\xa0+\xa0Sb v', 'topical Bacterial Cellulose bio-curatives', 'Brazil using pentavalent antimony (Sb v ', 'parenteral Sb v  alone or parenteral Sb v  plus topically applied BC bio-curatives']","['overall healing time', 'cure rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023283', 'cui_str': 'Cutaneous leishmaniasis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C3848565', 'cui_str': 'Antimony Cation (5+)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",20.0,0.0166288,CL patients treated with Sb v  + topical BC bio-curatives had a significantly higher cure rate at 60 days post initiation of treatment compared to CL patients treated with Sb v  alone (P=0.01).,"[{'ForeName': 'Fabiana S', 'Initials': 'FS', 'LastName': 'Celes', 'Affiliation': 'Instituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil.'}, {'ForeName': 'Hernane S', 'Initials': 'HS', 'LastName': 'Barud', 'Affiliation': 'Uniara, Araraquara, SP, Brazil.'}, {'ForeName': 'Sayonara M', 'Initials': 'SM', 'LastName': 'Viana', 'Affiliation': 'Instituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil.'}, {'ForeName': 'Pedro B', 'Initials': 'PB', 'LastName': 'Borba', 'Affiliation': 'Instituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil.'}, {'ForeName': 'Paulo R L', 'Initials': 'PRL', 'LastName': 'Machado', 'Affiliation': 'Serviço de Imunologia, HUPES-UFBA, Salvador, BA, Brazil.; INCT - Instituto de Investigação em Doenças Tropicais, Salvador, BA, Brazil.'}, {'ForeName': 'Edgar M', 'Initials': 'EM', 'LastName': 'Carvalho', 'Affiliation': 'Instituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil; Serviço de Imunologia, HUPES-UFBA, Salvador, BA, Brazil.; INCT - Instituto de Investigação em Doenças Tropicais, Salvador, BA, Brazil.'}, {'ForeName': 'Camila I', 'Initials': 'CI', 'LastName': 'de Oliveira', 'Affiliation': 'Instituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil; INCT - Instituto de Investigação em Doenças Tropicais, Salvador, BA, Brazil. Electronic address: camila.indiani@fiocruz.br.'}]",Acta tropica,['10.1016/j.actatropica.2021.106192']
2338,34670161,"Efficacy and Safety of Lianhuaqingwen Capsules, a repurposed Chinese Herb, in Patients with Coronavirus disease 2019: A multicenter, prospective, randomized controlled trial [Phytomedicine 85 (2021) 153242].",,2021,,['Patients with Coronavirus disease 2019'],"['Lianhuaqingwen Capsules, a repurposed Chinese Herb']",['Efficacy and Safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C3852361', 'cui_str': 'lianhuaqingwen'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0290048,,"[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan, 430060, Hubei province, China.'}, {'ForeName': 'Wei-Jie', 'Initials': 'WJ', 'LastName': 'Guan', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Road, Guangzhou, Guangdong province, 510120, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Gynaecology and Obstetrics, Wuhan Red Cross Hospital, 392 Hongkong Road, Wuhan 430015, Hubei province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi Province, China.'}, {'ForeName': 'Lanjuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of College of Medicine, Zhejiang province, China.'}, {'ForeName': 'Boli', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'The First Teaching Hospital of Tianjin University of traditional Chinese medicine.'}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Beijing Hospital of traditional Chinese medicine, Beijing, China.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Beijing Ditan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Youan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Shanghai University of traditional Chinese medicine, Shanghai, China.'}, {'ForeName': 'Zifeng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Road, Guangzhou, Guangdong province, 510120, P.R. China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Road, Guangzhou, Guangdong province, 510120, P.R. China.'}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Fuyang Second People's Hospital, Fuyang, China.""}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, Hubei province, China.'}, {'ForeName': 'Chaomin', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan, 430060, Hubei province, China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Jia', 'Affiliation': 'Hebei Yiling Hospital, National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, Hebei province, 050035, P.R China. Electronic address: jzhjiazhenhua@163.com.'}, {'ForeName': 'Nan-Shan', 'Initials': 'NS', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Road, Guangzhou, Guangdong province, 510120, P.R. China. Electronic address: nanshan@vip.163.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2021.153775']
2339,34666346,Spinal Anesthesia with Targeted Sedation based on Bispectral Index Values Compared with General Anesthesia with Masked Bispectral Index Values to Reduce Delirium: The SHARP Randomized Controlled Trial.,"BACKGROUND


Reducing depth of anesthesia and anesthetic exposure may help prevent delirium, but trials have been conflicting. Most studies were conducted under general anesthesia or in cognitively impaired patients. It is unclear whether reducing depth of anesthesia beyond levels consistent with general anesthesia reduces delirium in cognitively intact patients. The authors' objective was to determine whether a bundled approach to reduce anesthetic agent exposure as determined by Bispectral Index (BIS) values (spinal anesthesia with targeted sedation based on BIS values) compared with general anesthesia (masked BIS) reduces delirium.
METHODS


Important eligibility criteria for this parallel-arm randomized trial were patients 65 yr or greater undergoing lumbar spine fusion. The intervention group received spinal anesthesia with targeted sedation to BIS greater than 60 to 70. The control group received general anesthesia (masked BIS). The primary outcome was delirium using the Confusion Assessment Method daily through postoperative day 3, with blinded assessment.
RESULTS


The median age of 217 patients in the analysis was 72 (interquartile range, 69 to 77). The median BIS value in the spinal anesthesia with targeted sedation based on BIS values group was 62 (interquartile range, 53 to 70) and in the general anesthesia with masked BIS values group was 45 (interquartile range, 41 to 50; P < 0.001). Incident delirium was not different in the spinal anesthesia with targeted sedation based on BIS values group (25.2% [28 of 111] vs. the general anesthesia with masked BIS values group (18.9% [20 of 106]; P = 0.259; relative risk, 1.22 [95% CI, 0.85 to 1.76]). In prespecified subgroup analyses, the effect of anesthetic strategy differed according to the Mini-Mental State Examination, but not the Charlson Comorbidity Index or age. Two strokes occurred among patients receiving spinal anesthesia and one death among patients receiving general anesthesia.
CONCLUSIONS


Spinal anesthesia with targeted sedation based on BIS values compared with general anesthesia with masked BIS values did not reduce delirium after lumbar fusion.
EDITOR’S PERSPECTIVE


",2021,"Incident delirium was not different in the spinal anesthesia with targeted sedation based on BIS values group (25.2% [28 of 111] vs. the general anesthesia with masked BIS values group (18.9% [20 of 106]; P = 0.259; relative risk, 1.22 [95% CI, 0.85 to 1.76]).","['cognitively intact patients', 'patients 65 yr or greater undergoing lumbar spine fusion', 'The median age of 217 patients in the analysis was 72 (interquartile range, 69 to 77']","['general anesthesia (masked BIS', 'Spinal Anesthesia with Targeted Sedation', 'General Anesthesia with Masked Bispectral Index Values', 'spinal anesthesia with targeted sedation to BIS', 'spinal anesthesia']","['Delirium', 'Bispectral Index Values', 'delirium using the Confusion Assessment Method daily through postoperative day 3, with blinded assessment', 'Incident delirium', 'Bispectral Index (BIS) values (spinal anesthesia with targeted sedation based on BIS values', 'median BIS value']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.170375,"Incident delirium was not different in the spinal anesthesia with targeted sedation based on BIS values group (25.2% [28 of 111] vs. the general anesthesia with masked BIS values group (18.9% [20 of 106]; P = 0.259; relative risk, 1.22 [95% CI, 0.85 to 1.76]).","[{'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Edwards', 'Affiliation': 'Maryland Spine Center at Mercy, Baltimore, Maryland.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Mercy Anesthesiology Associates, Baltimore, Maryland.'}, {'ForeName': 'Emily Ledford', 'Initials': 'EL', 'LastName': 'Jones', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Yanek', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Esmaili', 'Affiliation': 'Mercy Anesthesiology Associates, Baltimore, Maryland.'}, {'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Gorashi', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Skelton', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kaganov', 'Affiliation': 'Wake Forest School of Medicine, Winston Salem, North Carolina.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Curto', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Noah L', 'Initials': 'NL', 'LastName': 'Lessing', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cha', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Colantuoni', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Neufeld', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Sieber', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Clayton L', 'Initials': 'CL', 'LastName': 'Dean', 'Affiliation': 'Maryland Spine Center at Mercy, Baltimore, Maryland.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Hogue', 'Affiliation': 'the Department of Anesthesiology, Northwestern Feinberg School of Medicine, Chicago, Illinois.'}]",Anesthesiology,['10.1097/ALN.0000000000004015']
2340,34743974,A comparison of augmented feedback and didactic training approaches to reduce spine motion during occupational lifting tasks.,"Manual handling training may be improved if it relied on the provision of individualized, augmented feedback about key movement features. The purpose of this study was to compare the reduction in sagittal spine motion during manual lifting tasks following two training approaches: didactic (DID) and augmented feedback (AUG). Untrained participants (n = 26) completed lifting tests (box, medication bag, and paramedic backboard) and a randomly-assigned intervention involving 50 practice box lifts. Lifting tests were performed immediately before and after training, and one-week after interventions. Both groups exhibited reductions in spine motions immediately and one-week after the interventions. However, the AUG intervention group elicited significantly greater reductions in 5 of 12 between-group comparisons (3 tasks × 4 spine motion variables). The results of the current study support the use of augmented feedback-based approaches to manual handling training over education-based approaches.",2021,"Untrained participants (n = 26) completed lifting tests (box, medication bag, and paramedic backboard) and a randomly-assigned intervention involving 50 practice box lifts.",['Untrained participants (n\xa0=\xa026) completed'],"['lifting tests (box, medication bag, and paramedic backboard) and a randomly-assigned intervention involving 50 practice box lifts', 'augmented feedback and didactic training approaches', 'two training approaches: didactic (DID) and augmented feedback (AUG', 'Manual handling training']","['sagittal spine motion', 'spine motion', 'spine motions']","[{'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0183440', 'cui_str': 'Spine board'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",50.0,0.00557695,"Untrained participants (n = 26) completed lifting tests (box, medication bag, and paramedic backboard) and a randomly-assigned intervention involving 50 practice box lifts.","[{'ForeName': 'Victor C H', 'Initials': 'VCH', 'LastName': 'Chan', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada; School of Human Kinetics, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Timothy N', 'Initials': 'TN', 'LastName': 'Welsh', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada; Centre for Motor Control, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Tremblay', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada; Centre for Motor Control, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Frost', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tyson A C', 'Initials': 'TAC', 'LastName': 'Beach', 'Affiliation': 'Centre for Motor Control, University of Toronto, Toronto, ON, Canada; Department of Kinesiology & Health Sciences, University of Waterloo, Waterloo, ON, Canada. Electronic address: tyson.beach@uwaterloo.ca.'}]",Applied ergonomics,['10.1016/j.apergo.2021.103612']
2341,34743963,Anti-caries evaluation of a nano-hydroxyapatite dental lotion for use after toothbrushing: An in situ study.,"OBJECTIVES


The aim of this randomized, double-blind, two-arm crossover in situ study was to investigate whether nano-hydroxyapatite (nanoHAP) dental lotion (Apagard Deep Care) applied immediately after tooth-brushing with nanoHAP toothpaste (Apagard M-plus) enhances the remineralization promotion and the demineralization inhibition efficacies of nanoHAP toothpastes.
METHODS


64 sound enamel blocks and 64 blocks bearing artificially-produced initial caries were produced from human permanent molar teeth. During each treatment period, lasting 14 days per arm, two blocks, one sound and one lesion-bearing, were exposed to either 5% nanoHAP-containing or placebo dental lotion after tooth-brushing with 5% nanoHAP toothpaste, via an intra-oral appliance worn by 30 adults in each of the study groups. Baseline and post-test mineral loss were quantified using transverse microradiography (TMR). One-sided t-test of one group mean was used for intragroup comparison, while two-sided t-test of two independent means was used to compare the two dental lotions.
RESULTS


Pairwise comparison (baseline vs. post-test) indicated significant (p<.001) remineralization by nanoHAP toothpaste in both groups. However, when compared against each other, there was a significantly (p<.001) greater percentage of remineralization with nanoHAP lotion [58.4(±1.8)%] than with placebo lotion [37.7(±2.2)%]. TMR examination showed absolute demineralization inhibition in sound enamel blocks exposed to either lotions.
CONCLUSIONS


Toothpaste containing 5% nanoHAP effectively remineralized initial caries and inhibited demineralization of healthy enamel; however, the application of a dental lotion containing 5% nanoHAP after brushing resulted in superior remineralization compared to a placebo lotion.
CLINICAL SIGNIFICANCE


Dental lotion containing 5% nanohydroxyapatite used immediately after toothbrushing with 5% nanohydroxyapatite toothpaste can serve as an adjunct to enhance the clinical benefits of the toothpaste.",2021,"RESULTS


Pairwise comparison (baseline vs. post-test) indicated significant (p<.001) remineralization by nanoHAP toothpaste in both groups.","['toothbrushing', '64 sound enamel blocks and 64 blocks bearing artificially-produced initial caries were produced from human permanent molar teeth']","['nanoHAP-containing or placebo dental lotion after tooth-brushing with 5% nanoHAP toothpaste, via an intra-oral appliance', 'nanoHAP toothpaste (Apagard M-plus', 'placebo lotion', 'nano-hydroxyapatite (nanoHAP) dental lotion (Apagard Deep Care', 'nano-hydroxyapatite dental lotion', 'nanoHAP lotion']",['absolute demineralization inhibition'],"[{'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0266858', 'cui_str': 'Incipient enamel caries'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0700185', 'cui_str': 'Decalcified structure'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",64.0,0.0654912,"RESULTS


Pairwise comparison (baseline vs. post-test) indicated significant (p<.001) remineralization by nanoHAP toothpaste in both groups.","[{'ForeName': 'Bennett T', 'Initials': 'BT', 'LastName': 'Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States. Electronic address: amaechi@uthscsa.edu.'}, {'ForeName': 'Dina O', 'Initials': 'DO', 'LastName': 'Alshareif', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Parveez A Abdul', 'Initials': 'PAA', 'LastName': 'Azees', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Marina A', 'Initials': 'MA', 'LastName': 'Shehata', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Patricia P', 'Initials': 'PP', 'LastName': 'Lima', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Parisa S', 'Initials': 'PS', 'LastName': 'Kalkhorani', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Evans', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Bagheri', 'Affiliation': 'Department of Biology, University of Texas at San Antonio, 1 UTSA Circle, San Antonio, TX 78249, United States.'}, {'ForeName': 'Linda O', 'Initials': 'LO', 'LastName': 'Okoye', 'Affiliation': 'Faculty of Dentistry, College of Medicine, University of Nigeria, Ituku-Ozalla, Enugu, Nigeria.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103863']
2342,34743899,"Dynamic Coronary Roadmap in Percutaneous Coronary Intervention: Results From an Open-Label, Randomized Trial.",,2021,,['Percutaneous Coronary Intervention'],[],[],"[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",[],[],,0.0178907,,"[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Piayda', 'Affiliation': ''}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Phinicarides', 'Affiliation': ''}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Afzal', 'Affiliation': ''}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Veulemans', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Bönner', 'Affiliation': ''}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Kelm', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Hellhammer', 'Affiliation': ''}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Polzin', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Zeus', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2021.08.068']
2343,34744265,EFFICACY OF CYCLOCRYOTHERAPY AND TRANSSCLERAL DIODE LASER CYCLOPHOTOCOAGULATION IN THE MANAGEMENT OF REFRACTORY GLAUCOMA.,"Treating advanced glaucoma often requires numerous therapeutic modalities in order to achieve the desired intraocular pressure (IOP) reduction. The purpose of this study was to evaluate the IOP lowering efficacy of both cyclocryotherapy (CCT) and transscleral diode laser cyclophotocoagulation (TS-DCPC) in the management of refractory primary open-angle glaucoma. This prospective, randomized, controlled clinical trial included 40 patients (40 eyes) with refractory glaucoma treated at the Eye Department, Clinical Center of Vojvodina, Novi Sad, Serbia, between January 2016 and June 2019. Twenty patients underwent CCT (group 1), while another twenty patients were treated with TS-DCPC (group 2). Each patient underwent complete eye examination on the treatment day, as well as follow-up eye examinations 7 days and 1, 6 and 12 months after the intervention, when IOP and number of anti-glaucoma drugs used were recorded. The median baseline IOP was 36.50 mm Hg (IQR, 28.75-42.00) in group 1 and 27.00 mm Hg (IQR, 22.00-35.00) in group 2. Follow-up measurements of IOP in group 1 showed the following results: 16.50 mm Hg (IQR, 7.75-20.00) (60% decrease from the baseline value), 12.00 mm Hg (IQR, 9.25-18.00) (67% decrease from the baseline value), 9.00 mm Hg (IQR, 2.00-13.75) (73% decrease from the baseline value), and 9.50 (IQR, 2.50-12.00) (75% decrease from the baseline value) after 7 days, 1, 6 and 12 months, respectively. Follow-up measurements of IOP in group 2 showed the following results: 16.00 mm Hg (IQR, 10.00-17.00) (48% decrease from the baseline value), 14.00 mm Hg (IQR, 10.00-16.00) (56% decrease from the baseline value), 14.00 mm Hg (IQR, 12.25-16.50) (43% decrease from the baseline value) and 14.00 mm Hg (IQR, 11.25-15.75) (53% decrease from the baseline value) after 7 days, 1, 6 and 12 months, respectively. The mean number of antiglaucoma drugs used decreased from 4 to 0.65±0.81 and 2.25±1.07 in groups 1 and 2, respectively. In conclusion, study results confirmed the CCT and TS-DCPC to have a rapid and statistically significant ocular hypotensive effect in eyes with refractory glaucoma at one-year follow-up.",2021,"The mean number of antiglaucoma drugs used decreased from 4 to 0.65±0.81 and 2.25±1.07 in groups 1 and 2, respectively.","['refractory primary open-angle glaucoma', '40 patients (40 eyes) with refractory glaucoma treated at the Eye Department, Clinical Center of Vojvodina, Novi Sad, Serbia, between January 2016 and June 2019', 'Twenty patients underwent']","['CCT', 'cyclocryotherapy (CCT) and transscleral diode laser cyclophotocoagulation (TS-DCPC', 'TS-DCPC']","['ocular hypotensive effect', 'intraocular pressure (IOP) reduction', 'median baseline IOP', 'IOP lowering efficacy', 'mean number of antiglaucoma drugs']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0206005', 'cui_str': 'Vojvodina'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0036708', 'cui_str': 'Republic of Serbia'}]","[{'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0197666', 'cui_str': 'Cryotherapy of ciliary body'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0395490', 'cui_str': 'Photocoagulation of ciliary body'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",40.0,0.091986,"The mean number of antiglaucoma drugs used decreased from 4 to 0.65±0.81 and 2.25±1.07 in groups 1 and 2, respectively.","[{'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Miljković', 'Affiliation': '1Faculty of Medicine, University of Novi Sad, Novi Sad, Vojvodina, Serbia; 2Eye Department, Clinical Centre of Vojvodina, Novi Sad, Vojvodina, Serbia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Babić', 'Affiliation': '1Faculty of Medicine, University of Novi Sad, Novi Sad, Vojvodina, Serbia; 2Eye Department, Clinical Centre of Vojvodina, Novi Sad, Vojvodina, Serbia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Čanadanović', 'Affiliation': '1Faculty of Medicine, University of Novi Sad, Novi Sad, Vojvodina, Serbia; 2Eye Department, Clinical Centre of Vojvodina, Novi Sad, Vojvodina, Serbia.'}, {'ForeName': 'Sofija', 'Initials': 'S', 'LastName': 'Davidović', 'Affiliation': '1Faculty of Medicine, University of Novi Sad, Novi Sad, Vojvodina, Serbia; 2Eye Department, Clinical Centre of Vojvodina, Novi Sad, Vojvodina, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Ljikar', 'Affiliation': '1Faculty of Medicine, University of Novi Sad, Novi Sad, Vojvodina, Serbia; 2Eye Department, Clinical Centre of Vojvodina, Novi Sad, Vojvodina, Serbia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Vasin', 'Affiliation': '1Faculty of Medicine, University of Novi Sad, Novi Sad, Vojvodina, Serbia; 2Eye Department, Clinical Centre of Vojvodina, Novi Sad, Vojvodina, Serbia.'}]",Acta clinica Croatica,['10.20471/acc.2021.60.02.01']
2344,34744156,"Effects of Etco2 on the Minimum Alveolar Concentration of Sevoflurane that Blunts the Adrenergic Response to Surgical Incision: A Prospective, Randomized, Double-Blinded Trial.","BACKGROUND


CO2 has anesthetic potency and effectively influences the circulatory system. We investigated the effects of Etco2 on the minimum alveolar concentration of sevoflurane that blunts the adrenergic response to surgical incision (MAC-BAR) in patients undergoing radical surgery for gastric carcinoma.
METHODS


Ninety patients undergoing radical gastric-carcinoma surgery under general anesthesia were enrolled and randomly assigned into 3 groups. After intubation, the Etco2 in group L (n = 30), group N (n = 30), and group H (n = 30) was adjusted to 25 mm Hg ≤ Etco2 <30 mm Hg, 30 mm Hg ≤ Etco2 < 40 mm Hg, and 40 mm Hg ≤ Etco2 < 45 mm Hg, respectively, by changes in controlled ventilation. Hemodynamics and depth of anesthesia were observed before and after skin incision. The MAC-BAR of sevoflurane for each group was determined using an up-and-down sequential-allocation technique.
RESULTS


To obtain 7 crossovers, 25, 26, and 26 patients were used in group L, group N, and group H, respectively. The MAC-BAR of sevoflurane using the up-and-down method for group H was significantly lower than that for group L (2.3% [95% confidence interval {CI}, 2.2-2.4] vs 2.9% [95% CI, 2.7-3.0]; difference, -0.6% [95% CI, -0.7 to -0.4], P < .001) and group N (2.3% [95% CI, 2.2-2.4] vs 2.8% [95% CI, 2.8-2.9]; difference, -0.5% [95% CI, -0.7 to -0.4], P < .001), while no significant difference was found between group L and group N (P = 1.000).
CONCLUSIONS


Higher Etco2 levels (Etco2 values equal to 40 mm Hg or higher) can effectively decrease the MAC-BAR of sevoflurane in patients undergoing radical surgery for gastric carcinoma.",2021,"The MAC-BAR of sevoflurane using the up-and-down method for group H was significantly lower than that for group L (2.3% [95% confidence interval {CI}, 2.2-2.4] vs 2.9% [95% CI, 2.7-3.0]; difference, -0.6% [95% CI, -0.7 to -0.4], P < .001) and group N (2.3% [95% CI, 2.2-2.4] vs 2.8% [95% CI, 2.8-2.9]; difference, -0.5% [95% CI, -0.7 to -0.4], P < .001), while no significant difference was found between group L and group N (P = 1.000).
","['patients undergoing radical surgery for gastric carcinoma', 'Ninety patients undergoing radical gastric-carcinoma surgery under general anesthesia']","['Sevoflurane', 'surgical incision (MAC-BAR', 'sevoflurane']","['MAC-BAR', 'Hemodynamics and depth of anesthesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0699791', 'cui_str': 'Carcinoma of stomach'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0474710', 'cui_str': 'Depth of anesthesia'}]",90.0,0.220499,"The MAC-BAR of sevoflurane using the up-and-down method for group H was significantly lower than that for group L (2.3% [95% confidence interval {CI}, 2.2-2.4] vs 2.9% [95% CI, 2.7-3.0]; difference, -0.6% [95% CI, -0.7 to -0.4], P < .001) and group N (2.3% [95% CI, 2.2-2.4] vs 2.8% [95% CI, 2.8-2.9]; difference, -0.5% [95% CI, -0.7 to -0.4], P < .001), while no significant difference was found between group L and group N (P = 1.000).
","[{'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Tianhua', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Huiting', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Wenqian', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Danping', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Longhui', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005784']
2345,34744149,Implication of Ivabradine Therapy in Up-Titrating Beta-Blocker Dose in Patients with Systolic Dysfunction.,"Ivabradine, which reduces heart rate (HR) without affecting sympathetic nerve activity, improves mortality and morbidity in patients with systolic dysfunction. However, its impact on up-titrating a concomitant beta-blocker dose in such a cohort, via increasing cardiac output and blood pressure and improving tolerability to beta-blockers, remains unknown. In this single-center, prospective, randomized control trial, patients with systolic dysfunction, defined as left ventricular ejection fraction < 50%, sinus rhythm, heart rate > 75 bpm, systolic blood pressure between 90 and 110 mmHg, and New York Heart Association functional class III or IV, who are refractory to up-titration of a beta-blocker due to symptomatic hypotension, dizziness, or worsening heart failure, were assigned to the 20 ivabradine arm or the 20 conventional therapy arm and followed-up for 6 months. The primary outcome is the daily dose of beta-blocker at 6-months follow-up. The secondary outcomes are echocardiographic parameters including overlap between E-wave and A-wave in transmitral diastolic filling flow, plasma B-type natriuretic peptide level, 6-minute walk distance, and heart failure readmission rate. By conducting this study, we hope to demonstrate the clinical benefit of ivabradine therapy in up-titrating beta-blockers and improving clinical outcomes in patients with systolic dysfunction.",2021,"Ivabradine, which reduces heart rate (HR) without affecting sympathetic nerve activity, improves mortality and morbidity in patients with systolic dysfunction.","['Patients with Systolic Dysfunction', 'patients with systolic dysfunction', 'patients with systolic dysfunction, defined as left ventricular ejection fraction < 50%, sinus rhythm, heart rate > 75 bpm, systolic blood pressure between 90 and 110 mmHg, and New York Heart Association functional class III or IV, who are refractory to up-titration of a beta-blocker due to symptomatic hypotension, dizziness, or worsening heart failure']","['Ivabradine Therapy', 'Ivabradine', 'ivabradine therapy']","['heart rate (HR', 'echocardiographic parameters including overlap between E-wave and A-wave in transmitral diastolic filling flow, plasma B-type natriuretic peptide level, 6-minute walk distance, and heart failure readmission rate', 'daily dose of beta-blocker', 'mortality and morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C2599617', 'cui_str': 'a wave'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0911647,"Ivabradine, which reduces heart rate (HR) without affecting sympathetic nerve activity, improves mortality and morbidity in patients with systolic dysfunction.","[{'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Imamura', 'Affiliation': 'Second Department of Internal Medicine, University of Toyama.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Onoda', 'Affiliation': 'Second Department of Internal Medicine, University of Toyama.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Uchida', 'Affiliation': 'Second Department of Internal Medicine, University of Toyama.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Kinugawa', 'Affiliation': 'Second Department of Internal Medicine, University of Toyama.'}]",International heart journal,['10.1536/ihj.21-387']
2346,34744616,The Effects of Intermittent Theta Burst Stimulation on Functional Brain Network Following Stroke: An Electroencephalography Study.,"Objective:  Intermittent theta burst stimulation (iTBS) is a special form of repetitive transcranial magnetic stimulation (rTMS), which effectively increases cortical excitability and has been widely used as a neural modulation approach in stroke rehabilitation. As effects of iTBS are typically investigated by motor evoked potentials, how iTBS influences functional brain network following stroke remains unclear. Resting-state electroencephalography (EEG) has been suggested to be a sensitive measure for evaluating effects of rTMS on brain functional activity and network. Here, we used resting-state EEG to investigate the effects of iTBS on functional brain network in stroke survivors.  Methods:  We studied thirty stroke survivors (age: 63.1 ± 12.1 years; chronicity: 4.0 ± 3.8 months; UE FMA: 26.6 ± 19.4/66) with upper limb motor dysfunction. Stroke survivors were randomly divided into two groups receiving either Active or Sham iTBS over the ipsilesional primary motor cortex. Resting-state EEG was recorded at baseline and immediately after iTBS to assess the effects of iTBS on functional brain network.  Results:  Delta and theta bands interhemispheric functional connectivity were significantly increased after Active iTBS ( P  = 0.038 and 0.011, respectively), but were not significantly changed after Sham iTBS ( P  = 0.327 and 0.342, respectively). Delta and beta bands global efficiency were also significantly increased after Active iTBS ( P  = 0.013 and 0.0003, respectively), but not after Sham iTBS ( P  = 0.586 and 0.954, respectively).  Conclusion:  This is the first study that used EEG to investigate the acute neuroplastic changes after iTBS following stroke. Our findings for the first time provide evidence that iTBS modulates brain network functioning in stroke survivors. Acute increase in interhemispheric functional connectivity and global efficiency after iTBS suggest that iTBS has the potential to normalize brain network functioning following stroke, which can be utilized in stroke rehabilitation.",2021,Stroke survivors were randomly divided into two groups receiving either Active or Sham iTBS over the ipsilesional primary motor cortex.,"['thirty stroke survivors (age: 63.1 ± 12.1 years; chronicity: 4.0 ± 3.8 months; UE FMA: 26.6 ± 19.4/66) with upper limb motor dysfunction', 'Stroke survivors']","['rTMS', 'Active or Sham iTBS', 'repetitive transcranial magnetic stimulation (rTMS', 'Intermittent theta burst stimulation (iTBS', 'Intermittent Theta Burst Stimulation', 'Resting-state electroencephalography (EEG', 'iTBS']","['Functional Brain Network', 'Delta and beta bands global efficiency', 'Results:  Delta and theta bands interhemispheric functional connectivity', 'Resting-state EEG', 'interhemispheric functional connectivity and global efficiency']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0547045', 'cui_str': 'Chronicity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",30.0,0.0244008,Stroke survivors were randomly divided into two groups receiving either Active or Sham iTBS over the ipsilesional primary motor cortex.,"[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Shunxi', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Songbin', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Junhui', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Guiyuan', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Guangqing', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ""Department of Rehabilitation Medicine, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}]",Frontiers in neuroscience,['10.3389/fnins.2021.755709']
2347,34744430,Clinical Comparison of a Silicone Hydrogel and a Conventional Hydrogel Daily Disposable Contact Lens.,"Purpose


To compare the subjective performances of verofilcon A daily disposable silicone hydrogel contact lenses (CLs) and etafilcon A hydrogel CLs.
Methods


Successful wearers of spherical soft CLs for distance correction were prospectively randomized to wear verofilcon A or etafilcon A lenses for 1 week and crossed over to the alternative lenses. The primary study objective was a comparison of distance visual acuity (VA). Exploratory endpoints included subjective overall lens preference (5-point scale) and subjective ratings (10-point scales) of end-of-day (EOD) vision, overall handling, insertion comfort, EOD comfort, overall quality of vision, overall comfort, vision throughout the day, lens handling at insertion, and lens handling at removal.
Results


Of 92 subjects (184 eyes), 46 each were randomized to verofilcon A or etafilcon A lenses and subsequently crossed over to the other lenses. Evaluation of distance VA showed that verofilcon A lenses were noninferior to etafilcon A lenses. Comparison of lens preference showed that 68 (73.9%) subjects somewhat or strongly preferred verofilcon A lenses, whereas 21 (22.9%) somewhat or strongly preferred etafilcon A lenses (p<0.0001). Mean ± SD ratings of EOD vision (8.6±1.5 vs 7.7±1.9), overall handling (8.7±1.5 vs 6.9±2.3), insertion comfort (9.2±1.0 vs 7.7±1.9), and EOD comfort (8.0±1.9 vs 7.0±2.2) were all significantly (p≤0.0001 each) higher for verofilcon A than for etafilcon A lenses. Mean ± SD ratings of overall quality of vision (8.9±1.2 vs 8.2±1.8), overall comfort (8.6±1.5 vs 7.4±1.8), vision throughout the day (8.9±1.3 vs 8.1±1.8), lens handling at insertion (9.0±1.4 vs 6.9±2.5), and lens handling at removal (8.3±2.1 vs 7.7±2.2) were also significantly higher for verofilcon A lenses. No subject experienced any ocular adverse events.
Conclusion


After 1 week of wear, the study population reported that ratings for subjective endpoints were significantly higher for verofilcon A lenses than for etafilcon A lenses.",2021,"Comparison of lens preference showed that 68 (73.9%) subjects somewhat or strongly preferred verofilcon A lenses, whereas 21 (22.9%) somewhat or strongly preferred etafilcon A lenses (p<0.0001).","['92 subjects (184 eyes', 'Methods\n\n\nSuccessful wearers of spherical soft CLs for distance correction']","['verofilcon A or etafilcon', 'verofilcon A daily disposable silicone hydrogel contact lenses (CLs) and etafilcon A hydrogel CLs', 'verofilcon A or etafilcon A lenses', 'Silicone Hydrogel and a Conventional Hydrogel Daily Disposable Contact Lens']","['vision', 'overall comfort', 'distance visual acuity (VA', 'subjective overall lens preference (5-point scale) and subjective ratings (10-point scales) of end-of-day (EOD) vision, overall handling, insertion comfort, EOD comfort, overall quality of vision, overall comfort, vision throughout the day, lens handling at insertion, and lens handling at removal', 'lens handling at removal', 'Mean ± SD ratings of overall quality of vision', 'EOD comfort', 'overall handling', 'Mean ± SD ratings of EOD vision', 'ratings for subjective endpoints', 'lens handling at insertion', 'ocular adverse events', 'insertion comfort']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0009838', 'cui_str': 'Hydrophilic contact lens'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0756851', 'cui_str': 'etafilcon'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018578', 'cui_str': 'Handling (Psychology)'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.159644,"Comparison of lens preference showed that 68 (73.9%) subjects somewhat or strongly preferred verofilcon A lenses, whereas 21 (22.9%) somewhat or strongly preferred etafilcon A lenses (p<0.0001).","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'EyeCare Professionals of Powell, Powell, OH, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Giedd', 'Affiliation': 'Maitland Vision Center, Maitland, FL, USA.'}, {'ForeName': 'Lakshman N', 'Initials': 'LN', 'LastName': 'Subbaraman', 'Affiliation': 'Alcon Research, LLC, Johns Creek, GA, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S332651']
2348,34744427,"Roflumilast (Daliresp®) to reduce acute pulmonary events in fibrotic sarcoidosis: a multi-center, double blind, placebo controlled, randomized clinical trial.","Background


Fibrotic sarcoidosis patients often have acute events of increased cough and sputum production. We evaluated the impact of roflumilast in fibrotic sarcoidosis patients with repeated episodes of increased cough and sputum.
Methods


Sarcoidosis patients with pulmonary fibrosis and at least two acute episodes in the previous year were randomized to receive either roflumilast (ROF) or placebo (PLA) in a double blind, placebo controlled multi-center trial. Subjects were assessed initially and every three months for 12 months. At each visit, spirometry and health related quality of life questionnaires were completed. For each subject, the best forced expiratory volume at 1 second (FEV-1) was noted.
Results


Of the 38 subjects who enrolled in the study, 28 subjects (14 in each group) received at least three months of treatment and 10 in each arm completing all 12 months of study. During the treatment, patients treated with ROF were less likely to have visits in which the FEV-1 was less than 90% of the best FEV-1 (Odds ratio=0.34 (0.16 to 0.76 95% confidence interval, p=0.0073). At the end of treatment with ROF, patients had a significant improvement in their KSQ LUNG (Initial visit: 45.3 ± 6.89 (Mean ± S.D.); Last visit: 52.6± 7.91, p<0.05) with no change for PLA treated patients.
Conclusion


Patients treated with at least three months of roflumilast had fewer follow-up visits with an FEV-1 of less than 90% of best value. At the end of treatment, ROF treated patients had a better quality of life as assessed by KSQ LUNG.
Clinical Trial Registration


NCT01830959.",2021,"Last visit: 52.6± 7.91, p<0.05) with no change for PLA treated patients.
","['fibrotic sarcoidosis', 'Sarcoidosis patients with pulmonary fibrosis and at least two acute episodes in the previous year', '38 subjects who enrolled in the study, 28 subjects (14 in each group', 'fibrotic sarcoidosis patients with repeated episodes of increased cough and sputum']","['placebo', 'roflumilast (ROF) or placebo (PLA', 'Roflumilast (Daliresp®']","['quality of life', 'KSQ LUNG']","[{'cui': 'C0036202', 'cui_str': 'Sarcoidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0965618', 'cui_str': 'Roflumilast'}, {'cui': 'C2980159', 'cui_str': 'Daliresp'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]",28.0,0.375826,"Last visit: 52.6± 7.91, p<0.05) with no change for PLA treated patients.
","[{'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Baughman', 'Affiliation': 'University of Cincinnati Medical Center, Cincinnati, OH USA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Judson', 'Affiliation': 'Albany Medical College, Albany, NY USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Culver', 'Affiliation': 'Cleveland Clinic, Cleveland, OH USA.'}, {'ForeName': 'Surinder S', 'Initials': 'SS', 'LastName': 'Birring', 'Affiliation': ""Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Parambil', 'Affiliation': 'Cleveland Clinic, Cleveland, OH USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Zeigler', 'Affiliation': 'University of Cincinnati Medical Center, Cincinnati, OH USA.'}, {'ForeName': 'Elyse E', 'Initials': 'EE', 'LastName': 'Lower', 'Affiliation': 'University of Cincinnati Medical Center, Cincinnati, OH USA.'}]","Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG",['10.36141/svdld.v38i3.11684']
2349,34744794,Association Between Changes in Serum and Skeletal Muscle Metabolomics Profile With Maximum Power Output Gains in Response to Different Aerobic Training Programs: The Times Study.,"Purpose:  High heterogeneity of the response of cardiorespiratory fitness (CRF) to standardized exercise doses has been reported in different training programs, but the associated mechanisms are not widely known. This study investigated whether changes in the metabolic profile and pathways in blood serum and the skeletal muscle are associated with the inter-individual variability of CRF responses to 8-wk of continuous endurance training (ET) or high-intensity interval training (HIIT).  Methods:  Eighty men, young and sedentary, were randomized into three groups, of which 70 completed 8 wk of intervention (> 90% of sessions): ET, HIIT, or control. Blood and vastus lateralis muscle tissue samples, as well as the measurement of CRF [maximal power output (MPO)] were obtained before and after the intervention. Blood serum and skeletal muscle samples were analyzed by 600 MHz  1 H-NMR spectroscopy (metabolomics). Associations between the pretraining to post-training changes in the metabolic profile and MPO gains were explored via three analytical approaches: (1) correlation between pretraining to post-training changes in metabolites' concentration levels and MPO gains; (2) significant differences between low and high MPO responders; and (3) metabolite contribution to significantly altered pathways related to MPO gains. After, metabolites within these three levels of evidence were analyzed by multiple stepwise linear regression. The significance level was set at 1%.  Results:  The metabolomics profile panel yielded 43 serum and 70 muscle metabolites. From the metabolites within the three levels of evidence (15 serum and 4 muscle metabolites for ET; 5 serum and 1 muscle metabolites for HIIT), the variance in MPO gains was explained: 77.4% by the intervention effects, 6.9, 2.3, 3.2, and 2.2% by changes in skeletal muscle pyruvate and valine, serum glutamine and creatine phosphate, respectively, in ET; and 80.9% by the intervention effects; 7.2, 2.2, and 1.2% by changes in skeletal muscle glycolate, serum creatine and creatine phosphate, respectively, in HIIT. The most changed and impacted pathways by these metabolites were: arginine and proline metabolism, glycine, serine and threonine metabolism, and glyoxylate and dicarboxylate metabolism for both ET and HIIT programs; and additional alanine, aspartate and glutamate metabolism, arginine biosynthesis, glycolysis/gluconeogenesis, and pyruvate metabolism for ET.  Conclusion:  These results suggest that regulating the metabolism of amino acids and carbohydrates may be a potential mechanism for understanding the inter-individual variability of CRF in responses to ET and HIIT programs.",2021,"The most changed and impacted pathways by these metabolites were: arginine and proline metabolism, glycine, serine and threonine metabolism, and glyoxylate and dicarboxylate metabolism for both ET and HIIT programs; and additional alanine, aspartate and glutamate metabolism, arginine biosynthesis, glycolysis/gluconeogenesis, and pyruvate metabolism for ET.  ","['Eighty men, young and sedentary']","['continuous endurance training (ET) or high-intensity interval training (HIIT', 'Aerobic Training Programs']","['Blood serum and skeletal muscle samples', 'MPO gains', 'metabolic profile and MPO gains', 'skeletal muscle glycolate, serum creatine and creatine phosphate', 'CRF [maximal power output (MPO', 'skeletal muscle pyruvate and valine, serum glutamine and creatine phosphate']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0017948', 'cui_str': 'Hydroxyacetates'}, {'cui': 'C0858112', 'cui_str': 'Serum creatine'}, {'cui': 'C0031634', 'cui_str': 'fosfocreatine'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]",,0.0104382,"The most changed and impacted pathways by these metabolites were: arginine and proline metabolism, glycine, serine and threonine metabolism, and glyoxylate and dicarboxylate metabolism for both ET and HIIT programs; and additional alanine, aspartate and glutamate metabolism, arginine biosynthesis, glycolysis/gluconeogenesis, and pyruvate metabolism for ET.  ","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Laboratory of Exercise Physiology, School of Physical Education, University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Renata G', 'Initials': 'RG', 'LastName': 'Duft', 'Affiliation': 'Laboratory of Exercise Physiology, School of Physical Education, University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Silas Gabriel', 'Initials': 'SG', 'LastName': 'de Oliveira-Nunes', 'Affiliation': 'Laboratory of Exercise Physiology, School of Physical Education, University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'André L L', 'Initials': 'ALL', 'LastName': 'de Andrade', 'Affiliation': 'School of Medical Sciences, University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Cavaglieri', 'Affiliation': 'Laboratory of Exercise Physiology, School of Physical Education, University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Mara Patricia Traina', 'Initials': 'MPT', 'LastName': 'Chacon-Mikahil', 'Affiliation': 'Laboratory of Exercise Physiology, School of Physical Education, University of Campinas (UNICAMP), São Paulo, Brazil.'}]",Frontiers in physiology,['10.3389/fphys.2021.756618']
2350,34744773,Cardiovascular Responses to Simultaneous Diving and Muscle Metaboreflex Activation.,"Background:  The aim of study was to assess hemodynamic changes during the simultaneous activation of muscle metaboreflex (MM) and diving reflex (DR) in a laboratory setting. We hypothesized that as long as the exercise intensity is mild DR can overwhelm the MM.  Methods:  Ten trained divers underwent all four phases (randomly assigned) of the following protocol. (A) Postexercise muscle ischemia session (PEMI): 3 min of resting followed by 3 min of handgrip at 30% of maximum force, followed immediately by 3 min of PEMI on the same arm induced by inflating a sphygmomanometer. Three minutes of recovery was further allowed after the cuff was deflated for a total of 6 min of recovery. (B) Control exercise recovery session: the same rest-exercise protocol used for A followed by 6 min of recovery without inflation. (C) DR session: the same rest-exercise protocol used for A followed by 1 min of breath-hold (BH) with face immersion in cold water. (D) PEMI-DR session: the same protocol used for A with 60 s of BH with face immersion in cold water during the first minute of PEMI. Stroke volume (SV), heart rate (HR), and cardiac output (CO) were collected by means of an impedance method.  Results:  At the end of apnea, HR was decreased in condition C and D with respect to A (-40.8 and -40.3%, respectively vs. -9.1%;  p  < 0.05). Since SV increase was less pronounced at the same time point (C = +32.4 and D = +21.7% vs. A = +6.0;  p  < 0.05), CO significantly decreased during C and D with respect to A (-23 and -29.0 vs. -1.4%, respectively;  p  < 0.05).  Conclusion:  Results addressed the hypothesis that DR overcame the MM in our setting.",2021,"At the end of apnea, HR was decreased in condition C and D with respect to A (-40.8 and -40.3%, respectively vs. -9.1%;  p  < 0.05).",[],"['muscle metaboreflex (MM) and diving reflex (DR', 'Postexercise muscle ischemia session (PEMI']","['hemodynamic changes', 'Stroke volume (SV), heart rate (HR), and cardiac output (CO']",[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0599289', 'cui_str': 'Reflex, Diving'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",,0.0240996,"At the end of apnea, HR was decreased in condition C and D with respect to A (-40.8 and -40.3%, respectively vs. -9.1%;  p  < 0.05).","[{'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Di Giacomo', 'Affiliation': 'Department of Medical Sciences and Public Health, School of Sport Medicine, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanna Maria', 'Initials': 'GM', 'LastName': 'Ghiani', 'Affiliation': 'Department of Medical Sciences and Public Health, School of Sport Medicine, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Todde', 'Affiliation': 'Department of Medical Sciences and Public Health, School of Sport Medicine, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Tocco', 'Affiliation': 'Department of Medical Sciences and Public Health, School of Sport Medicine, University of Cagliari, Cagliari, Italy.'}]",Frontiers in physiology,['10.3389/fphys.2021.730983']
2351,34744766,Effects of Different Levels of Variability and Pressure Support Ventilation on Lung Function in Patients With Mild-Moderate Acute Respiratory Distress Syndrome.,"Background:  Variable pressure support ventilation (vPSV) is an assisted ventilation mode that varies the level of pressure support on a breath-by-breath basis to restore the physiological variability of breathing activity. We aimed to compare the effects of vPSV at different levels of variability and pressure support (Δ P   S ) in patients with acute respiratory distress syndrome (ARDS).  Methods:  This study was a crossover randomized clinical trial. We included patients with mild to moderate ARDS already ventilated in conventional pressure support ventilation (PSV). The study consisted of two blocks of interventions, and variability during vPSV was set as the coefficient of variation of the Δ P   S  level. In the first block, the effects of three levels of variability were tested at constant Δ P   S : 0% (PSV 0% , conventional PSV), 15% (vPSV 15% ), and 30% (vPSV 30% ). In the second block, two levels of variability (0% and variability set to achieve ±5 cmH 2 O variability) were tested at two ΔP S  levels (baseline Δ P   S  and Δ P   S  reduced by 5 cmH 2 O from baseline). The following four ventilation strategies were tested in the second block: PSV with baseline Δ P   S  and 0% variability (PSV BL ) or ±5 cmH 2 O variability (vPSV BL ), PSV with ΔP S  reduced by 5 cmH 2 O and 0% variability (PSV -5 ) or ±5 cmH 2 O variability (vPSV -5 ). Outcomes included gas exchange, respiratory mechanics, and patient-ventilator asynchronies.  Results:  The study enrolled 20 patients. In the first block of interventions, oxygenation and respiratory mechanics parameters did not differ between vPSV 15%  and vPSV 30%  compared with PSV 0% . The variability of tidal volume ( V   T ) was higher with vPSV 15%  and vPSV 30%  compared with PSV 0% . The incidence of asynchronies and the variability of transpulmonary pressure ( P   L ) were higher with vPSV 30%  compared with PSV 0% . In the second block of interventions, different levels of pressure support with and without variability did not change oxygenation. The variability of  V   T  and  P   L  was higher with vPSV -5  compared with PSV -5 , but not with vPSV BL  compared with PSV BL .  Conclusion:  In patients with mild-moderate ARDS, the addition of variability did not improve oxygenation at different pressure support levels. Moreover, high variability levels were associated with worse patient-ventilator synchrony.  Clinical Trial Registration:  www.clinicaltrials.gov, identifier: NCT01683669.",2021,The incidence of asynchronies and the variability of transpulmonary pressure ( P   L ) were higher with vPSV 30%  compared with PSV 0% .,"['patients with mild-moderate ARDS', 'enrolled 20 patients', 'patients with mild to moderate ARDS already ventilated in conventional pressure support ventilation (PSV', 'patients with acute respiratory distress syndrome (ARDS', 'Patients With Mild-Moderate Acute Respiratory Distress Syndrome']","['Variability and Pressure Support Ventilation', ':  Variable pressure support ventilation (vPSV', 'vPSV']","['incidence of asynchronies and the variability of transpulmonary pressure', 'variability of  V   T  and  P   L', 'Lung Function', 'variability (PSV BL ) or ±5 cmH 2 O variability (vPSV BL ), PSV with ΔP S  reduced by 5 cmH 2 O and 0% variability (PSV -5 ) or ±5 cmH 2 O variability (vPSV -5 ', 'variability of tidal volume ( V   T ', 'gas exchange, respiratory mechanics, and patient-ventilator asynchronies', 'oxygenation and respiratory mechanics parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",20.0,0.0721882,The incidence of asynchronies and the variability of transpulmonary pressure ( P   L ) were higher with vPSV 30%  compared with PSV 0% .,"[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Ball', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Yuda', 'Initials': 'Y', 'LastName': 'Sutherasan', 'Affiliation': 'Division of Pulmonary and Pulmonary Critical Care Medicine, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Fiorito', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': ""Dall'Orto"", 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Maiello', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vargas', 'Affiliation': 'Department of Neurosciences, Reproductive and Odonthostomatological Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Robba', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Iole', 'Initials': 'I', 'LastName': 'Brunetti', 'Affiliation': 'Anesthesia and Intensive Care, Ospedale Policlinico San Martino Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) for Oncology and Neurosciences, Genova, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': ""D'Antini"", 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Raimondo', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huhle', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Patricia R M', 'Initials': 'PRM', 'LastName': 'Rocco', 'Affiliation': 'Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Gama de Abreu', 'Affiliation': 'Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.'}]",Frontiers in physiology,['10.3389/fphys.2021.725738']
2352,34744750,"Single Dose of SHR-1222, a Sclerostin Monoclonal Antibody, in Healthy Men and Postmenopausal Women With Low Bone Mass: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase I Study.","SHR-1222 is a humanized monoclonal antibody targeting sclerostin and has the potential to promote bone formation and reduce bone resorption. This study was aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SHR-1222 in healthy men and postmenopausal women with low bone mass (BMD). It was a randomized, double-blind, placebo-controlled, dose-escalation, phase I study. Subjects received SHR-1222 at 50, 100, 200, 300, and 400 mg sequentially or matching placebo subcutaneously. Totally, 50 subjects with low BMD were enrolled and randomly assigned; 10 received placebo and 40 received SHR-1222 (50 mg, n = 4; 100, 200, 300, or 400 mg, n = 9). The most common adverse events that occurred at least 10% higher in subjects with SHR-1222 treatment than those with placebo were decreased blood calcium, blood urine present, increased blood cholesterol, electrocardiogram T wave abnormal, urinary tract infection, increased blood pressure diastolic, and positive bacterial test. All the above adverse events were mild in severity and well resolved except one of increased blood cholesterol in a subject lost to follow-up. The serum SHR-1222 concentration increased in a dose-dependent manner. Administration of SHR-1222 upregulated the bone-formation markers N-terminal propeptide of type 1 procollagen, osteocalcin, and bone-specific alkaline phosphatase, while downregulated the bone-resorption marker β-C-telopeptide. The BMD at the lumbar spine notably rose after a single dose of SHR-1222. The largest increase occurred in the 400 mg cohort (3.8, 6.7, and 6.1% on day 29, 57, and 85, respectively; compared with 1.4, 0.8, and 1.0% in the placebo group). Although 10.0% of subjects receiving SHR-1222 tested positive for anti-SHR-1222 antibodies, no obvious effects of antibody formation were found on pharmacokinetics. Overall, SHR-1222 was well tolerated at doses from 50 to 400 mg and is a promising new remedy for osteoporosis.  Clinical Trial Registration:  http://www.clinicaltrials.gov, NCT03870100.",2021,"Administration of SHR-1222 upregulated the bone-formation markers N-terminal propeptide of type 1 procollagen, osteocalcin, and bone-specific alkaline phosphatase, while downregulated the bone-resorption marker β-C-telopeptide.","['50 subjects with low BMD', 'healthy men and postmenopausal women with low bone mass (BMD', 'Healthy Men and Postmenopausal Women With Low Bone Mass']","['Placebo', 'SHR-1222', 'placebo', 'placebo subcutaneously', 'placebo and 40 received SHR-1222']","['blood calcium, blood urine present, increased blood cholesterol, electrocardiogram T wave abnormal, urinary tract infection, increased blood pressure diastolic, and positive bacterial test', 'safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity', 'serum SHR-1222 concentration', 'blood cholesterol', 'bone-formation markers N-terminal propeptide of type 1 procollagen, osteocalcin, and bone-specific alkaline phosphatase', 'antibody formation']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1439030', 'cui_str': 'SHORT ROOT protein, Arabidopsis'}]","[{'cui': 'C0729820', 'cui_str': 'Blood calcium measurement'}, {'cui': 'C0947999', 'cui_str': 'Blood urine present'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0438167', 'cui_str': 'EKG: T wave abnormal'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C2242638', 'cui_str': 'Bacterial test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1439030', 'cui_str': 'SHORT ROOT protein, Arabidopsis'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}]",50.0,0.282164,"Administration of SHR-1222 upregulated the bone-formation markers N-terminal propeptide of type 1 procollagen, osteocalcin, and bone-specific alkaline phosphatase, while downregulated the bone-resorption marker β-C-telopeptide.","[{'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Dai', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Pingfei', 'Initials': 'P', 'LastName': 'Fang', 'Affiliation': 'Phase I Clinical Trial Center and Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Phase I Clinical Trial Center and Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Qiangyong', 'Initials': 'Q', 'LastName': 'Yan', 'Affiliation': 'Phase I Clinical Trial Center and Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Lingfeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Phase I Clinical Trial Center and Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Zhuang', 'Affiliation': 'Department of Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Department of Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.'}, {'ForeName': 'Yantao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhong', 'Affiliation': 'Department of Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.'}, {'ForeName': 'Zeyu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.'}, {'ForeName': 'Zhifeng', 'Initials': 'Z', 'LastName': 'Sheng', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Hunan Provincial Key Laboratory of Metabolic Bone Diseases, Department of Metabolism and Endocrinology, and Health Management Center, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2021.770073']
2353,34744740,The Efficacy and Safety of Multiple Dose Regimens of Kudzu ( Pueraria lobata ) Root Extract on Bone and Cartilage Turnover and Menopausal Symptoms.,"Background:  Menopause is associated with detrimental changes in turnover of bone and cartilage and a variety of symptoms with negative impact on the quality of life. Naturally occurring isoflavones from  Radix Pueraria lobata , Kudzu root, may possess chondroprotective and symptom-relieving properties, but efficacy and safety of dosing and dose frequencies required for pharmacological action is unclear.  Purpose:  This clinical trial evaluates the efficacy on bone and cartilage turnover, menopausal symptoms, and safety of five dose regimens of Kudzu root extract administered either once, twice or three times daily in women with at least mild menopausal symptoms.  Materials and Methods:  Fifty postmenopausal women were randomized equally into five different dose regimen groups of Kudzu root extract in a four-week, parallel group, open-label, single-center, exploratory study design. Biomarkers CTX-I and CTX-II reflecting bone and cartilage degradation, respectively, were assessed in blood samples and 24-h urine samples. Change from baseline in the Menopause Rating Scale (MRS) and subscales was evaluated. Safety endpoints were frequency of adverse events, changes in hematology and safety chemistry data, vital signs and electrocardiogram.  Results:  Fifty women (Age 54.2 years, SD: 2.9) were randomized. After 4 weeks of treatment, biomarkers of bone resorption and cartilage degradation were statistically significantly reduced from baseline levels in the group receiving two capsules three times a day, serum/urine CTX-I (-18.4%, 95% CI: -8.1 to -27.5,  p  = 0.001/-34.2%, 95% CI: -21.6 to -44.7,  p  < 0.0001), urine CTX-II (-17.4% 95% CI: -2.5 to -30.0,  p  = 0.02). The observed effects were consistent across study groups but appeared to favour three times daily dosing. Four weeks of treatment led to statistically significant reductions in the MRS Total Score ( p  < 0.0001-0.03) in four out of five treatment groups. Kudzu root extract was well tolerated in all dose regimens, and no serious adverse events were reported.  Conclusion:  The results indicate that Kudzu extract may possess beneficial effects on bone and cartilage health and may be a promising natural alternative to existing treatments for menopausal symptoms. Kudzu root extract was well tolerated for short-term treatment of mild to severe menopausal symptoms in women in all tested doses and dose frequencies.",2021,Four weeks of treatment led to statistically significant reductions in the MRS Total Score ( p  < 0.0001-0.03) in four out of five treatment groups.,"['women with at least mild menopausal symptoms', 'Fifty postmenopausal women', 'Results:  Fifty women (Age 54.2\xa0years, SD: 2.9) were randomized']","['Kudzu root extract', 'Root Extract', 'Kudzu ( Pueraria lobata ', 'Kudzu extract']","['frequency of adverse events, changes in hematology and safety chemistry data, vital signs and electrocardiogram', 'urine CTX-II', 'Bone and Cartilage Turnover and Menopausal Symptoms', 'Biomarkers CTX-I and CTX-II reflecting bone and cartilage degradation', 'MRS Total Score', 'Menopause Rating Scale (MRS) and subscales', 'biomarkers of bone resorption and cartilage degradation', 'bone and cartilage turnover, menopausal symptoms, and safety']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517808', 'cui_str': '54.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0950069', 'cui_str': 'Kudzu'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0950070', 'cui_str': 'Pueraria lobata'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007996', 'cui_str': 'Chemistry'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}]",50.0,0.0508643,Four weeks of treatment led to statistically significant reductions in the MRS Total Score ( p  < 0.0001-0.03) in four out of five treatment groups.,"[{'ForeName': 'Asger Reinstrup', 'Initials': 'AR', 'LastName': 'Bihlet', 'Affiliation': 'NBCD A/S, Herlev, Denmark.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Byrjalsen', 'Affiliation': 'NBCD A/S, Herlev, Denmark.'}, {'ForeName': 'Jeppe Ragnar', 'Initials': 'JR', 'LastName': 'Andersen', 'Affiliation': 'NBCD A/S, Herlev, Denmark.'}, {'ForeName': 'Simone Faurholt', 'Initials': 'SF', 'LastName': 'Simonsen', 'Affiliation': 'NBCD A/S, Herlev, Denmark.'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Mundbjerg', 'Affiliation': 'NBCD A/S, Herlev, Denmark.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Helmer', 'Affiliation': 'Sanos Clinic, Herlev, Denmark.'}, {'ForeName': 'Bente Juel', 'Initials': 'BJ', 'LastName': 'Riis', 'Affiliation': 'NBCD A/S, Herlev, Denmark.'}, {'ForeName': 'Morten Asser', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience A/S, Herlev, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Christiansen', 'Affiliation': 'NBCD A/S, Herlev, Denmark.'}]",Frontiers in pharmacology,['10.3389/fphar.2021.760629']
2354,34744918,A Novel Mindful-Compassion Art-Based Therapy for Reducing Burnout and Promoting Resilience Among Healthcare Workers: Findings From a Waitlist Randomized Control Trial.,"Protecting the mental health of healthcare workers is an urgent global public health priority. Healthcare workers, especially those immersed in palliative care, are prone to burnout due to the intense emotions associated with end-of-life caregiving. This study examines the efficacy of a novel, multimodal, and group-based Mindful-Compassion Art-based Therapy (MCAT) that integrates reflective self-awareness with creative emotional expression for protecting healthcare workers' mental health. A dual-arm open-label waitlist randomized controlled trial was conducted. A total of 56 healthcare workers were recruited from the largest homecare hospice in Singapore and randomized to the immediate-treatment condition of a standardized 6-week, 18-hours MCAT intervention ( n =29), or the waitlist-control condition ( n =27). Self-administered outcome measures on burnout, resilience, emotional regulation, self-compassion, death attitudes, and quality of life were collected at baseline, post-intervention/second-baseline at 6weeks, and follow-up/post-intervention at 12weeks. Results from mixed model ANOVAs reveal that treatment group participants experienced significant reduction in mental exhaustion, as well as significant improvements in overall emotional regulation, nonreactivity to intrusive thoughts, approach acceptance of death, and afterlife belief as compared to waitlist-control immediately after MCAT completion. Effect sizes of these impacts ranged from medium to large ( η   2 =0.65 to 0.170). Results from one-way ANOVAs further reveal that the treatment gains of reduced mental exhaustion and increased emotional regulation were maintained among treatment group participants at 12-weeks follow-up compared to baseline, with new benefits identified. These include increased ability to observe and describe one's experiences, elevated overall self-compassion, greater mindful awareness, enhanced common humanity, and better quality of life. Effect sizes of these impacts were large ( η   2 =0.128 to 0.298). These findings reflect the robust effectiveness and positive residual effects of MCAT for reducing burnout, building resilience, nurturing compassion, fostering collegial support, and promoting mental wellness among healthcare workers. The clinical model and applicability of MCAT in larger and more diverse caregiving contexts, such as family dementia care, are discussed.  Clinical Trial Registration:  ClinicalTrials.gov # NCT03440606, #NCT04548089.",2021,"Results from one-way ANOVAs further reveal that the treatment gains of reduced mental exhaustion and increased emotional regulation were maintained among treatment group participants at 12-weeks follow-up compared to baseline, with new benefits identified.","['56 healthcare workers were recruited from the largest homecare hospice in Singapore and randomized to the immediate-treatment condition of a standardized 6-week, 18-hours', 'Healthcare Workers', ""protecting healthcare workers' mental health""]","['novel, multimodal, and group-based Mindful-Compassion Art-based Therapy (MCAT', 'waitlist-control condition', 'MCAT intervention', 'MCAT']","['overall self-compassion, greater mindful awareness, enhanced common humanity, and better quality of life', 'burnout, resilience, emotional regulation, self-compassion, death attitudes, and quality of life', 'overall emotional regulation, nonreactivity to intrusive thoughts, approach acceptance of death, and afterlife belief', 'mental exhaustion', 'reduced mental exhaustion and increased emotional regulation']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0003827', 'cui_str': 'Art therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0020157', 'cui_str': 'Humanities'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0004274', 'cui_str': 'Attitudes to Death'}, {'cui': 'C0558066', 'cui_str': 'Intrusive thoughts'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1096625', 'cui_str': 'Mental exhaustion'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",56.0,0.13371,"Results from one-way ANOVAs further reveal that the treatment gains of reduced mental exhaustion and increased emotional regulation were maintained among treatment group participants at 12-weeks follow-up compared to baseline, with new benefits identified.","[{'ForeName': 'Andy Hau Yan', 'Initials': 'AHY', 'LastName': 'Ho', 'Affiliation': 'Action Research for Community Health Laboratory, Psychology Programme, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Tan-Ho', 'Affiliation': 'Action Research for Community Health Laboratory, Psychology Programme, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Thuy Anh', 'Initials': 'TA', 'LastName': 'Ngo', 'Affiliation': 'Action Research for Community Health Laboratory, Psychology Programme, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ong', 'Affiliation': 'Assisi Hospice, Singapore, Singapore.'}, {'ForeName': 'Poh Heng', 'Initials': 'PH', 'LastName': 'Chong', 'Affiliation': 'HCA Hospice Care, Singapore, Singapore.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Dignadice', 'Affiliation': 'HCA Hospice Care, Singapore, Singapore.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Potash', 'Affiliation': 'Art Therapy Program, The George Washington University, Ashburn, VA, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.744443']
2355,34744901,Imagining the Future: Future Imagination Training Decreases Delay Discounting Among Internet Addicts and Non-Problematic Users.,"To test whether future imagination can reduce the delay discounting rate of the Internet addicts, we recruited 40 Internet addicts (treatment sample) and 39 non-problematic users (control sample). We used a 2 (participant type: individuals with Internet addiction vs. non-problematic users) × 2 (training type: future event imagination training vs. control condition) × 2 (training session: first session vs. final session) mixed-subjects design to test our hypothesis. The participant type and training type were between the subjects and the training session was within the subject. Half of each sample (the Internet addicts and non-problematic users) was randomly assigned to complete five sessions of future imagination training and the other half was assigned to describe some daily events they had observed. We used the Barratt Impulsivity Scale (BIS) and delay discounting task to assess our outcome variable, such as addiction, impulsivity, and delay discounting rate. The results showed that the future imagination training significantly reduced the delay discounting rate (also for impulsivity and addiction) for both the Internet addicts and non-problematic users than the control condition. Besides, the negative effect of future imagination training on the delay discounting rates (for impulsivity and addiction) remained consistent across the five training sessions. These findings suggest that the future imagination training can be a useful approach to reduce the impulsivity among those who are addicted to the Internet.",2021,The results showed that the future imagination training significantly reduced the delay discounting rate (also for impulsivity and addiction) for both the Internet addicts and non-problematic users than the control condition.,"['2 (participant type: individuals with Internet addiction vs. non-problematic users', 'Half of each sample (the Internet addicts and non-problematic users', 'Internet Addicts and Non-Problematic Users', '40 Internet addicts (treatment sample) and 39 non-problematic users (control sample']","['future imagination training', 'Imagination Training', '× 2 (training type: future event imagination training vs. control condition', 'imagination training']","['delay discounting rate', 'delay discounting rates (for impulsivity and addiction', 'Barratt Impulsivity Scale (BIS) and delay discounting task to assess our outcome variable, such as addiction, impulsivity, and delay discounting rate']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0020913', 'cui_str': 'Use of imagination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",40.0,0.0119551,The results showed that the future imagination training significantly reduced the delay discounting rate (also for impulsivity and addiction) for both the Internet addicts and non-problematic users than the control condition.,"[{'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'School of Labor Economics, Capital University of Economics and Business, Beijing, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.731708']
2356,34744896,Exercise in the Park or Gym? The Physiological and Mental Responses of Obese People Walking in Different Settings at Different Speeds: A Parallel Group Randomized Trial.,"Evidence shows that physical activity has multiple health benefits for the body and mind of oneself, but little is known about the impacts of the setting and the intensity on exercise experience, especially for obese people. This study investigated the physiological and psychological effects of four walking conditions with different settings (park vs. gym) and intensity (slow vs. fast) on young obese adults. Subjects were 18-21 years old Chinese university students ( N  = 77), who were diagnosed as obese. They were randomly assigned to participate in one of the four activities in the field: slow walk in the park (2.8 km/h), fast walk in the park (5.5 km/h), slow walk in the gym, and fast walk in the gym. Physiological indices, including blood pressure and heart rate, were measured before and after the walk. Psychological responses were measured by the Symbol Digit Modalities Test, the mood states scale, and the semantic differential scale. This study of obese people aged 18-21 years confirmed the previous findings that exercising in natural environments better relieved stress and restored attentional level than indoor activities. The results suggested that the mood states of the participants and their environmental perceptions may be influenced by the walking conditions with different setting and speed. The findings can be used in planning and designing urban green spaces for promoting physical activity and making exercise plans for obese people.",2021,This study of obese people aged 18-21 years confirmed the previous findings that exercising in natural environments better relieved stress and restored attentional level than indoor activities.,"['Obese People Walking in Different Settings at Different Speeds', 'obese people aged 18-21 years', 'young obese adults', 'obese people', 'Subjects were 18-21 years old Chinese university students ( N  = 77), who were diagnosed as obese']","['four walking conditions with different settings (park vs. gym) and intensity (slow vs. fast', 'field: slow walk in the park (2.8 km/h), fast walk in the park (5.5 km/h), slow walk in the gym, and fast walk in the gym']","['Symbol Digit Modalities Test, the mood states scale, and the semantic differential scale', 'Psychological responses', 'blood pressure and heart rate']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439494', 'cui_str': 'km/h'}, {'cui': 'C3844008', 'cui_str': '5.5'}]","[{'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036611', 'cui_str': 'Differential, Semantic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0283604,This study of obese people aged 18-21 years confirmed the previous findings that exercising in natural environments better relieved stress and restored attentional level than indoor activities.,"[{'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Landscape Architecture, College of Horticulture, Post-doctoral Research Station in Public Administration, Nanjing Agricultural University, Nanjing, China.'}, {'ForeName': 'Quanfu', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Sports, Nanjing Agricultural University, Nanjing, China.'}, {'ForeName': 'Mingjuan', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Landscape Architecture, College of Horticulture, Nanjing Agricultural University, Nanjing, China.'}, {'ForeName': 'Qinghai', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Landscape Architecture, College of Horticulture, Nanjing Agricultural University, Nanjing, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.728826']
2357,34744885,The Effectiveness of a Centering Meditation Intervention on College Stress and Mindfulness: A Randomized Controlled Trial.,"Background:  Mental health concerns are climbing steadily on college campuses, and universities do not have the staffing and financial resources to address the overwhelming needs of students seeking counseling services. College counselors generally must place students on waitlists or refer them to external resources. Further, during the COVID-19 pandemic, university counselors have been working tirelessly to treat students through online formats. Alternative, online, evidence-based interventions offer college counselors a significant advantage in effectively treating their students. We seek to expand the empirical evidence for mindfulness interventions through online formats for the college population. We registered the study (ISRCTN13587045) at www.isrctn.com.  Objective:  We examined the effectiveness of a unique online centering meditation and its impact on stress and trait mindfulness in the college population.  Methods:  Through a randomized controlled trial, the treatment group participated in a 4-week intervention of centering for 10 min each morning and night. We measured stress and mindfulness in both groups through the Perceived Stress Scale and Cognitive and Affective Mindfulness Scale-Revised at baseline, 2 weeks, and 4 weeks.  Results:  The centering meditation treatment had a statistically significant positive impact on stress and mindfulness compared to a waitlist control group. The meditation group had an average of 64% adherence rate.  Conclusion:  The study findings indicate that individuals who participate in a 4-week online centering intervention showed improved levels of stress and trait mindfulness over time.  Clinical Trial Registration:  WHO International Clinical Registry Platform, identifier: ISRCTN13587045.",2021,The centering meditation treatment had a statistically significant positive impact on stress and mindfulness compared to a waitlist control group.,"['College counselors', 'college counselors', 'College Stress and Mindfulness', 'college population']","['Centering Meditation Intervention', 'unique online centering meditation']","['stress and trait mindfulness', 'adherence rate', 'stress and mindfulness', 'Perceived Stress Scale and Cognitive and Affective Mindfulness Scale-Revised', 'levels of stress and trait mindfulness']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",,0.128396,The centering meditation treatment had a statistically significant positive impact on stress and mindfulness compared to a waitlist control group.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Dorais', 'Affiliation': 'College of William & Mary, Williamsburg, VA, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gutierrez', 'Affiliation': 'College of William & Mary, Williamsburg, VA, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.720824']
2358,34745352,Le vaccin chinois CoronaVac® à l’épreuve contre placebo en Turquie.,,2021,,[],[],[],[],[],[],,0.232948,,"[{'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Manus', 'Affiliation': ''}]",Revue francophone des laboratoires : RFL,['10.1016/S1773-035X(21)00207-0']
2359,34745329,Image Enhancement Model Based on Deep Learning Applied to the Ureteroscopic Diagnosis of Ureteral Stones during Pregnancy.,"Objective


To explore the image enhancement model based on deep learning on the effect of ureteroscopy with double J tube placement and drainage on ureteral stones during pregnancy. We compare the clinical effect of ureteroscopy with double J tube placement on pregnancy complicated with ureteral stones and use medical imaging to diagnose the patient's condition and design a treatment plan.
Methods


The image enhancement model is constructed using deep learning and implemented for quality improvement in terms of image clarity. In the way, the relationship of the media transmittance and the image with blurring artifacts was established, and the model can estimate the ureteral stone predicted map of each region. Firstly, we proposed the evolution-based detail enhancement method. Then, the feature extraction network is used to capture blurring artifact-related features. Finally, the regression subnetwork is used to predict the media transmittance in the local area. Eighty pregnant patients with ureteral calculi treated in our hospital were selected as the research object and were divided into a test group and a control group according to the random number table method, 40 cases in each group. The test group underwent ureteroscopy double J tube placement, and the control group underwent ureteroscopy lithotripsy. Combined with the ultrasound scan results of the patients before and after the operation, the operation time, time to get out of bed, and hospitalization time of the two groups of patients were compared. The operation success rate and the incidence of complications within 1 month after surgery were counted in the two groups of patients.
Results


We are able to improve the quality of the images prior to medical diagnosis. The total effective rate of the observation group was 100.0%, which is higher than that of the control group (90.0%). The difference between the two groups was statistically significant ( P  < 0.05). The adverse reaction rate in the observation group was 5.0%, which was lower than 17.5% in the control group. The difference between the two groups was statistically significant ( P  < 0.05). The comparison results are then prepared.
Conclusions


The image enhancement model based on deep learning is able to improve medical diagnosis which can assist radiologists to better locate the ureteral stones. Based on our method, double J tube placement under ureteroscopy has a significant effect on the treatment of ureteral stones during pregnancy, and it has good safety and is worthy of widespread application.",2021,"Based on our method, double J tube placement under ureteroscopy has a significant effect on the treatment of ureteral stones during pregnancy, and it has good safety and is worthy of widespread application.","['ureteral stones during pregnancy', 'Eighty pregnant patients with ureteral calculi treated in our hospital were selected as the research object']","['Deep Learning', 'ureteroscopy with double J tube placement and drainage', 'ureteroscopy double J tube placement, and the control group underwent ureteroscopy lithotripsy', 'ureteroscopy with double J tube placement']","['operation time, time to get out of bed, and hospitalization time', 'total effective rate', 'adverse reaction rate', 'operation success rate and the incidence of complications']","[{'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",80.0,0.0210944,"Based on our method, double J tube placement under ureteroscopy has a significant effect on the treatment of ureteral stones during pregnancy, and it has good safety and is worthy of widespread application.","[{'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Miao', 'Affiliation': ""Department of Radiation Oncology, The First People's Hospital of Fuyang (Fuyang First Affiliated Hospital of Zhejiang Chinese Medical University Ben Giang College), Hangzhou, China 311400.""}, {'ForeName': 'Xiao-Nan', 'Initials': 'XN', 'LastName': 'Miao', 'Affiliation': ""Department of Endocrinology, The First People's Hospital of Fuyang (Fuyang First Affiliated Hospital of Zhejiang Chinese Medical University Ben Giang College), Hangzhou, China 311400.""}, {'ForeName': 'Li-Yin', 'Initials': 'LY', 'LastName': 'Ye', 'Affiliation': ""Department of Urology, The First People's Hospital of Fuyang (Fuyang First Affiliated Hospital of Zhejiang Chinese Medical University Ben Giang College), Hangzhou, China 311400.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': ""Department of Ultrasound, The First People's Hospital of Fuyang (Fuyang First Affiliated Hospital of Zhejiang Chinese Medical University Ben Giang College), Hangzhou, China 311400.""}]",Computational and mathematical methods in medicine,['10.1155/2021/9548312']
2360,34745325,The Clinical Efficacy of Clopidogrel Bisulfate Tablets Combined with Olmesartan Medoxomil for Ischemic Stroke with Hypertension and the Effect of Angiotensin II Type 1 Receptor Level on Prognosis.,"Background


Ischemic stroke combined with hypertension can increase risks of stroke recurrence and death.
Aim


The aim of this study is to investigate the clinical efficacy of clopidogrel bisulfate tablets combined with olmesartan medoxomil in the treatment of ischemic stroke patients with hypertension and the effect of angiotensin II type 1 receptor (AT 1 R) level on prognosis.
Methods


Ninety ischemic stroke patients with hypertension were chosen for continuous treatment with clopidogrel bisulfate tablets and olmesartan medoxomil for 12 months. The Modified Edinburgh Scandinavian Stroke Scale (MESSS) score, Brunnstrom score, Barthel score, death, recurrence, and progression of cerebrovascular residual lesions were observed and recorded during the treatment period. According to the plasma AT 1 R expression of the patients before treatment, the patients were divided into a high-AT 1 R group and low-AT 1 R group. Then, survival analysis was performed.
Results


Compared with pretreatment, the MESSS scores of the patients at the first, second, third, sixth, ninth, and twelfth months after treatment were reduced ( p  < 0.01) while the Brunnstrom score and Barthel score were prominently boosted ( p  < 0.01). Compared with the low-AT 1 R group, patients in the high-AT 1 R group had higher rates of stroke recurrence and progression of residual cerebrovascular lesions ( p  < 0.05).
Conclusion


Clopidogrel bisulfate tablets combined with olmesartan medoxomil has prominent clinical effects in the treatment of ischemic stroke patients with hypertension, evidently improving the prognosis. In addition, the level of AT 1 R may be a vital factor affecting the prognosis.",2021,"The Modified Edinburgh Scandinavian Stroke Scale (MESSS) score, Brunnstrom score, Barthel score, death, recurrence, and progression of cerebrovascular residual lesions were observed and recorded during the treatment period.","['ischemic stroke patients with hypertension and the effect of angiotensin II type 1 receptor (AT 1 R) level on prognosis', 'Ninety ischemic stroke patients with hypertension', 'Ischemic Stroke with Hypertension', 'ischemic stroke patients with hypertension']","['Clopidogrel Bisulfate Tablets Combined with Olmesartan Medoxomil', 'clopidogrel bisulfate tablets and olmesartan medoxomil', 'clopidogrel bisulfate tablets combined with olmesartan medoxomil', 'olmesartan medoxomil']","['MESSS scores', 'Modified Edinburgh Scandinavian Stroke Scale (MESSS) score, Brunnstrom score, Barthel score, death, recurrence, and progression of cerebrovascular residual lesions', 'Brunnstrom score and Barthel score', 'rates of stroke recurrence and progression of residual cerebrovascular lesions', 'stroke recurrence and death']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0529330', 'cui_str': 'Angiotensin Type 1 Receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0633084', 'cui_str': 'Plavix'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0386393', 'cui_str': 'olmesartan medoxomil'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0240951', 'cui_str': 'Scandinavian'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}]",,0.0262738,"The Modified Edinburgh Scandinavian Stroke Scale (MESSS) score, Brunnstrom score, Barthel score, death, recurrence, and progression of cerebrovascular residual lesions were observed and recorded during the treatment period.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Air Force Military Medical University, Xi'an, 710038, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Air Force Military Medical University, Xi'an, 710038, China.""}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Air Force Military Medical University, Xi'an, 710038, China.""}, {'ForeName': 'Haiyang', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Air Force Military Medical University, Xi'an, 710038, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Sun', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Air Force Military Medical University, Xi'an, 710038, China.""}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Air Force Military Medical University, Xi'an, 710038, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': ""Department of Nursing, Tangdu Hospital, Air Force Military Medical University, Xi'an, 710038, China.""}]",Computational and mathematical methods in medicine,['10.1155/2021/4487393']
2361,34745309,"Combined Therapy with Traditional Chinese Medicine and Antiplatelet Drugs for Ischemic Heart Disease: Mechanism, Efficacy, and Safety.","Ischemic heart disease is a significant risk factor that threatens human health, and antiplatelet drugs are routinely used to treat cases in clinical settings. Chinese medicine for promoting blood circulation and removing blood stasis (PBCRBSCM) can often be combined with antiplatelet drugs to treat ischemic heart disease. PBCRBSCM can inhibit platelet adhesion, activation, and aggregation; moreover, PBCRBSCM in combination with antiplatelet drugs exerts antiplatelet effects. The mechanism is related to several factors, including the inhibition of platelet activation and aggregation, improvement of the hemodynamic status and coagulation function, and correction of metabolism and inflammation. PBCRBSCM can also regulate the absorption and metabolism of conventional antiplatelet drugs and protect the gastric mucosal epithelial cells against damage induced by conventional antiplatelet drugs. Randomized controlled trials have confirmed that PBCRBSCM preparations and the active ingredients in these preparations can reduce resistance to aspirin and clopidogrel so that the combination of these drugs can exert their antiplatelet effects. In the perioperative treatment of patients with stable angina pectoris, unstable angina pectoris, and acute coronary syndrome undergoing percutaneous coronary intervention therapy, preparations of the active ingredients of PBCRBSCM combined with antiplatelet drugs and other conventional Western medicine treatments have been proven effective. The efficacy and safety of such combinations have also been extensively verified. Considerable progress has been made to understand the antiplatelet mechanism of PBCRBSCM. However, most clinical studies had problems, such as limited sample size and inappropriate research design, which has limited the translational use of PBCRBSCM in antiplatelet therapy. A large-scale, multicenter, randomized controlled study with cardiovascular events as the endpoint is still to be conducted to provide evidence for the combined application of PBCRBSCM and antiplatelet drugs in the prevention and treatment of ischemic heart disease.",2021,PBCRBSCM can also regulate the absorption and metabolism of conventional antiplatelet drugs and protect the gastric mucosal epithelial cells against damage induced by conventional antiplatelet drugs.,"['patients with stable angina pectoris, unstable angina pectoris, and acute coronary syndrome undergoing percutaneous coronary intervention therapy']","['Chinese medicine', 'Traditional Chinese Medicine and Antiplatelet Drugs']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}]",[],,0.0263116,PBCRBSCM can also regulate the absorption and metabolism of conventional antiplatelet drugs and protect the gastric mucosal epithelial cells against damage induced by conventional antiplatelet drugs.,"[{'ForeName': 'Zongliang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiaoya', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': ""Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Longtao', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/9956248']
2362,34745307,Safety of Different Anesthesia Methods Combined with Intravenous Fast Channel Anesthesia in Lower Extremity Orthopedic Surgery of the Elderly.,"Objective


To compare the safety of different anesthesia methods combined with intravenous fast channel anesthesia in elderly lower extremity surgery and the effect on postoperative outcome.
Methods


A total of 106 elderly patients who underwent lower extremity orthopedic surgery in our hospital from February 2018 to February 2021 were selected and randomly divided into the control group ( n  = 53) and the observation group ( n  = 53) according to random number table. All patients received intravenous fast-track anesthesia. On this basis, the control group received spinal-epidural anesthesia, and the observation group received iliac fascial space block on the affected side combined with sciatic nerve block. The operation conditions, blood pressure and heart rate changes, awakening time, postoperative ICU admission rate, and complications were compared between the two groups.
Results


There was no statistical difference in the success rate of one-time operation between the two groups ( P  > 0.05). The times of using analgesics and vasoactive drugs and the dosage of propofol in the observation group during the operation were lower than those in the control group, and the difference was statistically significant ( P  < 0.05). At T2, T3, and T4, the levels of HR, DBP, and SBP in the observation group were lower than those in the control group, and the difference was statistically significant ( P  < 0.05). After operation, the time of awakening, spontaneous breathing recovery, and extubation in the observation group were lower than those in the control group, and the difference were statistically significant ( P  < 0.05). The incidence of complications in the observation group was lower than that in the control group, the cognitive impairment was the most significant one in the incidence of single complication, and the difference was statistically significant ( P  < 0.05).
Conclusion


Based on the combined intravenous fast channel anesthesia, the operation difficulty of the affected side iliac fascial space block combined with sciatic nerve block is the same as that of spinal-epidural anesthesia. It has a higher success rate of one operation, better analgesic and anesthetic effects during the operation, and little effect on blood flow of patients. It can maintain relatively stable heart rate and blood pressure and does not easily cause postoperative complications. Its safety is higher than that of spinal-epidural anesthesia.",2021,"The incidence of complications in the observation group was lower than that in the control group, the cognitive impairment was the most significant one in the incidence of single complication, and the difference was statistically significant ( P  < 0.05).
","['Lower Extremity Orthopedic Surgery of the Elderly', 'elderly lower extremity surgery', '106 elderly patients who underwent lower extremity orthopedic surgery in our hospital from February 2018 to February 2021']","['propofol', 'anesthesia methods combined with intravenous fast channel anesthesia', 'intravenous fast-track anesthesia', 'Intravenous Fast Channel Anesthesia', 'spinal-epidural anesthesia, and the observation group received iliac fascial space block on the affected side combined with sciatic nerve block']","['time of awakening, spontaneous breathing recovery, and extubation', 'success rate of one-time operation', 'operation conditions, blood pressure and heart rate changes, awakening time, postoperative ICU admission rate, and complications', 'incidence of complications', 'levels of HR, DBP, and SBP', 'cognitive impairment', 'stable heart rate and blood pressure']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0187763', 'cui_str': 'Surgical procedure on lower extremity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",106.0,0.0339893,"The incidence of complications in the observation group was lower than that in the control group, the cognitive impairment was the most significant one in the incidence of single complication, and the difference was statistically significant ( P  < 0.05).
","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Suzhou Kowloon Hospital, Shanghai Jiao Tong University School of Medicine, Suzhou, Jiangsu 215021, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Huaian Hospital of Traditional Medicine, Huaian, Jiangsu 223001, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Huaian Jianghuai Hospital, Huaian, Jiangsu 223001, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Jing', 'Affiliation': 'Department of Anesthesiology, The Affiliated Huaian Hospital of Xuzhou Medical University, Huaian, Jiangsu 223002, China.'}, {'ForeName': 'Dajin', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Huaian Hospital of Xuzhou Medical University, Huaian, Jiangsu 223002, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/9787879']
2363,34745306,Clinical Impact of Nurses-Physicians Collaboration Intervention on the Treatment of Immune Recurrent Spontaneous Abortion with Low-Molecular-Weight Heparin.,"Anticoagulation is currently the preferred and effective treatment for patients with recurrent spontaneous abortion (RSA), but, due to the prevalence of mood disorders in RSA patients and the high number of adverse effects associated with long-term medication, effective care measures are often required. In this study, 94 patients with immune-type RSA who were admitted to our hospital from January 2018 to June 2019 were selected and randomly divided into a control group and a study group of 47 patients each; both groups received low-molecular-weight heparin treatment after admission, and the control group received conventional nursing interventions during treatment, while the patients in the study group received integrated medical and nursing care interventions. Pregnancy outcomes, pre- and postintervention scores on the Self-Assessment Scale (SAS), Self-Depression Scale (SDS), and Pittsburgh Sleep Quality Index (PSQI), levels of serum gamma-interferon (IFN- γ ) and interleukin-4 (IL-4) and their ratios, complications, and patient satisfaction with the intervention were observed in both groups. The results showed that the success rate of fetal preservation in the study group (89.36%) was significantly higher than that in the control group (68.09%) ( P  < 0.05). After treatment, SAS, SDS, and PSQI scores decreased in both groups, with the study group being lower ( P  < 0.05). IFN- γ  and IFN- γ /IL-4 levels decreased and IL-4 levels increased in both groups after treatment, with IFN- γ  and IFN- γ /IL-4 being significantly lower and IL-4 levels being significantly higher in the study group than in the control group ( P  < 0.05). The incidence of adverse drug reactions in the study group was significantly lower than that in the control group ( P  < 0.05). Patients in the study group were more satisfied with all aspects of the intervention than the control group ( P  < 0.05). These results suggest that nurses-physicians collaboration intervention may improve the effectiveness of low-molecular-weight heparin therapy in patients with immune-type RSA. It helps to improve patient pregnancy outcomes, mood, sleep quality, and immune function and increases patient satisfaction.",2021,"γ  and IFN- γ /IL-4 levels decreased and IL-4 levels increased in both groups after treatment, with IFN- γ  and IFN- γ /IL-4 being significantly lower and IL-4 levels being significantly higher in the study group than in the control group ( P  < 0.05).","['patients with recurrent spontaneous abortion (RSA', '94 patients with immune-type RSA who were admitted to our hospital from January 2018 to June 2019', 'Immune Recurrent Spontaneous Abortion with Low-Molecular-Weight Heparin', 'patients with immune-type RSA']","['IFN', 'Nurses-Physicians Collaboration Intervention', 'low-molecular-weight heparin treatment after admission, and the control group received conventional nursing interventions', 'integrated medical and nursing care interventions']","['IL-4 levels', 'SAS, SDS, and PSQI scores', 'patient pregnancy outcomes, mood, sleep quality, and immune function and increases patient satisfaction', 'incidence of adverse drug reactions', 'success rate of fetal preservation', 'Pregnancy outcomes, pre- and postintervention scores on the Self-Assessment Scale (SAS), Self-Depression Scale (SDS), and Pittsburgh Sleep Quality Index (PSQI), levels of serum gamma-interferon (IFN- γ ) and interleukin-4 (IL-4) and their ratios, complications, and patient satisfaction with the intervention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2733531', 'cui_str': 'Low molecular weight heparin therapy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]","[{'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",94.0,0.0164747,"γ  and IFN- γ /IL-4 levels decreased and IL-4 levels increased in both groups after treatment, with IFN- γ  and IFN- γ /IL-4 being significantly lower and IL-4 levels being significantly higher in the study group than in the control group ( P  < 0.05).","[{'ForeName': 'Miaocheng', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Obstetrics, Huizhou Central People's Hospital, Huizhou, Guangdong 516000, China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics, Huizhou Central People's Hospital, Huizhou, Guangdong 516000, China.""}, {'ForeName': 'Peiru', 'Initials': 'P', 'LastName': 'Deng', 'Affiliation': ""Department of Obstetrics, Huizhou Central People's Hospital, Huizhou, Guangdong 516000, China.""}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/9290720']
2364,34745298,A Clinical Study on the Treatment of Children's Short Stature with Auxiliary Comprehensive Management Combined with Growth Patch.,"Objective


To explore the clinical effect of auxiliary comprehensive management combined with growth patch in the treatment of childhood idiopathic short stature (ISS).
Methods


From September 2017 to December 2019, 120 children with ISS who met the selection criteria were collected. Random number table method divided them into 2 groups: one group was given auxiliary comprehensive management and recorded as the routine group ( n  = 60), and the other group was given auxiliary comprehensive management and combined growth patch treatment and recorded as the combination group ( n  = 60). The course of treatment was 12 months. The effects of the two methods on children's height, bone age, body weight, and insulin-like growth factor (IGF)-1 and IGF-binding protein (IGFBP)-3 levels were compared.
Results


There was no statistical difference between the two groups in baseline height, genetic height, baseline bone age, baseline body weight, and body weight before and after treatment ( P  > 0.05). After treatment, the heights of the two groups were higher than before for the same group, the height growth values and predicted adult height of the combination group were higher than those of the routine group, and the predicted adult height of the combination group was higher than the genetic height of the same group ( P  < 0.001). There was no statistical difference in IGF-1 and IGFBP-3 levels before treatment between the two groups ( P  > 0.05). The levels of IGF-1 and IGFBP-3 after treatment in the two groups were higher than those in the same group before treatment, and the combination group was higher than that in the routine group ( P  < 0.05).
Conclusion


On the basis of auxiliary comprehensive management, combined with growth patch for the treatment of children with ISS, it can effectively increase the height of the children, improve the levels of serum IGF-1 and IGFBP-3, and have significant clinical effects, which is beneficial to the healthy growth of the children.",2021,There was no statistical difference in IGF-1 and IGFBP-3 levels before treatment between the two groups ( P  > 0.05).,"[""Children's Short Stature with"", 'childhood idiopathic short stature (ISS', 'Methods\n\n\nFrom September 2017 to December 2019, 120 children with ISS who met the selection criteria were collected', 'children with ISS']","['Auxiliary Comprehensive Management Combined with Growth Patch', 'auxiliary comprehensive management combined with growth patch', 'auxiliary comprehensive management and recorded as the routine group ( n \u2009=\u200960), and the other group was given auxiliary comprehensive management and combined growth patch treatment']","['baseline height, genetic height, baseline bone age, baseline body weight, and body weight', ""children's height, bone age, body weight, and insulin-like growth factor (IGF)-1 and IGF-binding protein (IGFBP)-3 levels"", 'IGF-1 and IGFBP-3 levels', 'levels of IGF-1 and IGFBP-3', 'genetic height', 'height growth values and predicted adult height']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013336', 'cui_str': 'Constitutional short stature'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0429620', 'cui_str': 'Bone age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0424639', 'cui_str': 'Height / growth measure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",120.0,0.0170023,There was no statistical difference in IGF-1 and IGFBP-3 levels before treatment between the two groups ( P  > 0.05).,"[{'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Department of Pediatrics, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou 318050, Zhejiang, China.'}, {'ForeName': 'Weizhu', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Pediatrics, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou 318050, Zhejiang, China.'}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Pediatrics, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou 318050, Zhejiang, China.'}, {'ForeName': 'Guanfu', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou 318050, Zhejiang, China.'}, {'ForeName': 'Qunhong', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou 318050, Zhejiang, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/7142006']
2365,34745295,Effect of Cinepazide Maleate on Serum Inflammatory Factors of ICU Patients with Severe Cerebral Hemorrhage after Surgery.,"Objective


To explore the effect of cinepazide maleate on serum inflammatory factors of intensive care unit (ICU) patients with severe cerebral hemorrhage after surgery.
Methods


116 ICU patients with severe cerebral hemorrhage treated in Taian Maternal and Child Health Hospital from June 2018 to June 2020 were selected as the research objects and randomly divided into the control group and experimental group, with 58 patients in each group. The control group was given routine treatment, while the experimental group was additionally given an intravenous drip of cinepazide maleate to compare the clinical efficacy and serum inflammatory factors between the two groups.
Results


The total effective rate in the experimental group was higher than that in the control group ( P  < 0.05). After treatment, the Glasgow Coma Scale (GCS), National Institutes of Health Stroke Scale (NIHSS), and Fugl-Meyer scores in both groups were better than those before treatment, and the scores in the experimental group were better than those in the control group ( P  < 0.05). The oxidative stress indexes such as total antioxidant capacity (T-Aoc), superoxide dismutase (SOD), and glutathione peroxidase (GSH-PX) in the experimental group were higher than those in the control group, while malondialdehyde (MDA) in the experimental group was lower than that in the control group ( P  < 0.05). The high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), interleukin-8 (IL-8), and tumor necrosis factor- α  (TNF- α ) levels in the experimental group were lower than those in the control group ( P  < 0.05). Compared with the control group, the cerebrovascular function in the experimental group was significantly improved ( P  < 0.05), with statistically significant differences.
Conclusion


Cinepazide maleate can effectively reduce the serum inflammatory factor levels of ICU patients with severe cerebral hemorrhage after surgery, alleviate the oxidative stress response in the body, and improve the cerebrovascular function and cerebral nerve function, which is worthy of clinical promotion.",2021,The total effective rate in the experimental group was higher than that in the control group ( P  < 0.05).,"['116 ICU patients with severe cerebral hemorrhage treated in Taian Maternal and Child Health Hospital from June 2018 to June 2020', 'ICU patients with severe cerebral hemorrhage after surgery', 'intensive care unit (ICU) patients with severe cerebral hemorrhage after surgery', 'ICU Patients with Severe Cerebral Hemorrhage after Surgery']","['cinepazide maleate', 'Cinepazide Maleate', 'α', 'Cinepazide maleate']","['total effective rate', 'cerebrovascular function', 'Serum Inflammatory Factors', 'oxidative stress indexes such as total antioxidant capacity (T-Aoc), superoxide dismutase (SOD), and glutathione peroxidase (GSH-PX', 'clinical efficacy and serum inflammatory factors', 'malondialdehyde (MDA', 'Glasgow Coma Scale (GCS), National Institutes of Health Stroke Scale (NIHSS), and Fugl-Meyer scores', 'high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), interleukin-8 (IL-8), and tumor necrosis factor', 'TNF- α ) levels', 'serum inflammatory factor levels']","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0055741', 'cui_str': 'cinepazide maleate'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",116.0,0.0223026,The total effective rate in the experimental group was higher than that in the control group ( P  < 0.05).,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Internal Medicine-Neurology, Linyi Central Hospital, Linyi 276400, Shandong Province, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Endoscopy Room, The Fourth People's Hospital of Jinan, Jinan 250031, Shandong Province, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Shang', 'Affiliation': ""Department of Equipment, Tai'an Maternal and Child Health Hospital, Tai'an 271000, Shandong Province, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Shandong First Medical University, Shandong Province Qianfoshan Hospital, Jinan 250014, Shandong Province, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/6562140']
2366,34745288,"Clinical Observation of Levothyroxine Sodium Combined with Selenium in the Treatment of Patients with Chronic Lymphocytic Thyroiditis and Hypothyroidism and the Effects on Thyroid Function, Mood, and Inflammatory Factors.","The purpose of this study was to investigate the therapeutic effects of levothyroxine sodium combined with selenium treatment and single levothyroxine sodium treatment on patients with chronic lymphocytic thyroiditis and hypothyroidism and to analyze the effects of different treatment regimens on patients' thyroid function, mood, and inflammatory factors, with the aim of providing a reference for clinical treatment. The subjects of the current study were 138 chronic lymphocytic thyroiditis (CLT) patients with hypothyroidism admitted to our hospital from May 2016 to September 2019 and were randomly divided into a control group taking levothyroxine sodium (LT4) treatment and a combined group of LT4 combined with selenium treatment, with 69 cases each. Patients in both groups were evaluated for efficacy after 3 months of treatment, and their thyroid function was observed by total triiodothyronine (TT3), total thyroxine (TT4), thyroid stimulating hormone (TSH), thyroid peroxidase antibody (TPOAb), and thyroid globulin antibody (TGAb), and their mood changes were observed by Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) scores. The levels of inflammatory factors such as interleukin-2 (IL-2), interleukin-10 (IL-10), and tumor necrosis factor- α  (TNF- α ) were measured, and the occurrence of adverse drug reactions during the treatment period was observed and recorded in all patients. The results showed that the total effective rate of the combined group was significantly higher than that of the control group. The levels of TT3, TT4, TSH, TgAb, and TPOAb, SAS and SDS scores, and levels of inflammatory factors such as IL-2, IL-10, and TNF- α  were significantly improved in both groups after treatment. Compared with the control group, TGAb, TPOAb, IL-2, TNF- α  levels, and SAS and SDS scores decreased more and IL-10 levels increased more in the combined group, while the differences of other indexes were not statistically significant. This suggests that LT4 has certain efficacy in treating CLT with hypothyroidism, and the combined selenium treatment can improve the therapeutic effect of LT4 and can play a greater role in improving patients' mood and immune and inflammatory responses.",2021,"Compared with the control group, TGAb, TPOAb, IL-2, TNF- α  levels, and SAS and SDS scores decreased more and IL-10 levels increased more in the combined group, while the differences of other indexes were not statistically significant.","['Patients with Chronic Lymphocytic Thyroiditis and Hypothyroidism', 'subjects of the current study were 138 chronic lymphocytic thyroiditis (CLT) patients with hypothyroidism admitted to our hospital from May 2016 to September 2019', 'patients with chronic lymphocytic thyroiditis and hypothyroidism']","['control group taking levothyroxine sodium (LT4) treatment and a combined group of LT4 combined with selenium treatment', 'Levothyroxine Sodium Combined with Selenium', 'LT4', 'levothyroxine sodium combined with selenium treatment and single levothyroxine sodium treatment']","['total effective rate', 'TGAb, TPOAb, IL-2, TNF- α  levels, and SAS and SDS scores', 'levels of TT3, TT4, TSH, TgAb, and TPOAb, SAS and SDS scores, and levels of inflammatory factors such as IL-2, IL-10, and TNF- α', 'Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) scores', 'occurrence of adverse drug reactions', 'total triiodothyronine (TT3), total thyroxine (TT4), thyroid stimulating hormone (TSH), thyroid peroxidase antibody (TPOAb), and thyroid globulin antibody (TGAb), and their mood changes', 'IL-10 levels', 'levels of inflammatory factors such as interleukin-2 (IL-2), interleukin-10 (IL-10), and tumor necrosis factor- α  (TNF- α ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0677607', 'cui_str': 'Hashimoto thyroiditis'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0079691', 'cui_str': 'levothyroxine sodium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0017649', 'cui_str': 'Globulin'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0076635', 'cui_str': 'Thyroid microsomal antibody'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}]",138.0,0.0182233,"Compared with the control group, TGAb, TPOAb, IL-2, TNF- α  levels, and SAS and SDS scores decreased more and IL-10 levels increased more in the combined group, while the differences of other indexes were not statistically significant.","[{'ForeName': 'Chunping', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Anhui Gerietric Institute, Hefei, Anhui 230022, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Anhui Gerietric Institute, Hefei, Anhui 230022, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Anhui Gerietric Institute, Hefei, Anhui 230022, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Anhui Gerietric Institute, Hefei, Anhui 230022, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Lv', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022, China.'}, {'ForeName': 'Defa', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Anhui Gerietric Institute, Hefei, Anhui 230022, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/5471281']
2367,34745282,"Efficacy of Different Preemptive Analgesia on Postoperative Analgesia, Oxidative Stress, and Inflammatory Response after Gynecological Laparoscopic Surgery.","Objective


To observe and compare the analgesic effects of oxycodone, pentazocine, and ketorolac tromethamine pre-emptive analgesia on gynecological laparoscopic patients after operation and the effects on oxidative stress and inflammatory reaction.
Methods


A total of 64 patients who underwent elective gynecological laparoscopic surgery in Yiwu Central Hospital from June 2019 to December 2020 were randomly divided into four groups ( n  = 16). Before anesthesia induction, oxycodone (group A), pentazocine (group B), ketorolac tromethamine (group C), and normal saline (group D) were, respectively, administered. Patients' mean arterial pressure (MAP) and heart rate (HR) changes, visual analogue scale (VAS), Bruggemann comfort scale (BCS), serum tumor necrosis factor- α  (TNF- α ), interleukin-6 (IL-6), C-reactive protein (CRP), blood glucose (CLU), serum cortisol level, postoperative adverse reactions, and additional analgesia were recorded at each time point.
Results


The MAP levels of T2 (immediate intubation), T3 (immediate catheter removal), and T4 (5 min after catheter removal) in the four groups were higher than those of T1 (quiescent state), and the HR levels T2, T3, and T4 were lower than those of T1 ( P  < 0.05). The MAP and HR levels of T2, T3, and T4 in patients of groups A, B, and C were lower than those of group D in the same period ( P  < 0.05). The VAS and BCS scores of groups A, B, and C at 1, 6, 12, and 24 h after operation were better than those of group D at the same time, and the scores of group A at 1 h and 6 h after operation were better than those of groups B and C at the same time ( P  < 0.05). The levels of serum TNF- α , IL-6, and CRP in the four groups of patients at 6, 12, and 24 h after operation were higher than those before operation, but those in groups A, B, and C were lower than those in group D, and those in group A were higher than those in groups B and C at 12 h and 24 h after operation ( P  < 0.05). The CLU and serum cortisol levels in the four groups were significantly higher at 6, 12, and 24 h after operation, but those in groups A, B, and C were lower than those in group D, and those in group A were lower than those in groups B and C at 6 and 12 h after operation ( P  < 0.05). There was no significant difference in the incidence of adverse reactions within 24 h between the four groups ( P  > 0.05). The incidence of additional analgesia in groups A, B, and C was lower than that in group D ( P  < 0.05).
Conclusion


Oxycodone, pentazocine, and ketorolac tromethamine are effective and safe in inhibiting postoperative pain and the generation of inflammatory factors and relieving inflammatory state in gynecological laparoscopic pre-emptive analgesia. Oxycodone has better postoperative analgesic effect because it can effectively alleviate stress reaction.",2021,"The CLU and serum cortisol levels in the four groups were significantly higher at 6, 12, and 24 h after operation, but those in groups A, B, and C were lower than those in group D, and those in group A were lower than those in groups B and C at 6 and 12 h after operation ( P  < 0.05).","['in Yiwu Central Hospital from June 2019 to December 2020', 'gynecological laparoscopic patients after operation', '64 patients who underwent', 'after Gynecological Laparoscopic Surgery']","['Preemptive Analgesia', 'oxycodone, pentazocine, and ketorolac tromethamine pre-emptive analgesia', 'ketorolac tromethamine', 'Oxycodone, pentazocine, and ketorolac tromethamine', 'Oxycodone', 'pentazocine', 'oxycodone', 'elective gynecological laparoscopic surgery', 'normal saline']","['MAP levels of T2 (immediate intubation), T3 (immediate catheter removal), and T4 (5\u2009min after catheter removal', 'CLU and serum cortisol levels', 'mean arterial pressure (MAP) and heart rate (HR) changes, visual analogue scale (VAS), Bruggemann comfort scale (BCS), serum tumor necrosis factor- α  (TNF- α ), interleukin-6 (IL-6), C-reactive protein (CRP), blood glucose (CLU), serum cortisol level, postoperative adverse reactions, and additional analgesia', 'oxidative stress and inflammatory reaction', 'incidence of additional analgesia', 'levels of serum TNF- α , IL-6, and CRP', 'incidence of adverse reactions', 'MAP and HR levels', 'Postoperative Analgesia, Oxidative Stress, and Inflammatory Response', 'VAS and BCS scores']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0030873', 'cui_str': 'Pentazocine'}, {'cui': 'C0064326', 'cui_str': 'Ketorolac tromethamine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",64.0,0.0145578,"The CLU and serum cortisol levels in the four groups were significantly higher at 6, 12, and 24 h after operation, but those in groups A, B, and C were lower than those in group D, and those in group A were lower than those in groups B and C at 6 and 12 h after operation ( P  < 0.05).","[{'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Yiwu Central Hospital, Yiwu, Zhejiang 322000, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Anorectal Surgery, Yiwu Central Hospital, Yiwu, Zhejiang 322000, China.'}, {'ForeName': 'Chenyu', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Yiwu Central Hospital, Yiwu, Zhejiang 322000, China.'}, {'ForeName': 'Jianyi', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Yiwu Central Hospital, Yiwu, Zhejiang 322000, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Dai', 'Affiliation': ""Department of Anesthesiology, Changshan County People's Hospital, Quzhou, Zhejiang 324200, China.""}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/4233716']
2368,34745278,Effect of Tongluozhitong Prescription-Assisted Intra-Articular Injection of Sodium Hyaluronate on VAS Score and Knee Lysholm Score in Patients with Knee Osteoarthritis.,"Knee osteoarthritis (KOA) has become one of the leading causes of workforce loss in the middle-aged and elderly population and a global public health problem second only to cardiovascular disease, so we need to find more effective treatments for this disease. In this study, we selected 120 patients with KOA admitted to our hospital from June 2018 to December 2020 and divided them into treatment group 1, treatment group 2, and joint group according to the random number table method, with 40 patients in each group. Treatment group 1 was treated with Tongluozhitong prescription dip-soaking therapy, treatment 2 group was treated with intra-articular injection of sodium hyaluronate, and the joint group was treated with a combination of both modalities for 4 weeks in all three groups. Clinical efficacy, visual analogue scale (VAS), Lysholm knee score (LKS), activity of daily living score (ADL), the levels of bone metabolic markers such as cartilage oligomeric matrix protein (COMP), type II collagen degradation maker (CTX-II), and matrix metalloproteinase-3 (MMP-3), and the levels of inflammatory mediators such as interleukin-1 β  (IL-1 β ), tumor necrosis factor- α  (TNF- α ), and hypersensitive C-reactive protein (hs-CRP) were used as observations to compare and analyze the therapeutic effects of the three treatment regimens in KOA patients. The results showed that the clinical excellence rates of the joint group, treatment group 1, and treatment group 2 were 72.50%, 50.00%, and 90.00%, respectively, with statistically significant differences between any two comparisons. After treatment, VAS scores, serum COMP, CTX-II, MMP-3, IL-1 β , TNF- α , and hs-CRP levels decreased in all three groups, and the levels of each index were as follows: joint group < treatment group 1 < treatment group 2, and the difference between any two comparisons was statistically significant. The LKS score and ADL score increased in all three groups, and the levels of each index were as follows: joint group > treatment group 1 > treatment group 2, with statistically significant differences in any two groups compared. None of the patients in the three groups experienced any significant adverse effects during treatment. This suggests that the dip-soaking therapy of Tongluozhitong prescription is more advantageous than intra-articular sodium hyaluronate injection treatment in suppressing the level of serum bone metabolic markers and inflammatory mediators, reducing pathological joint damage, relieving symptoms of pain, alleviating degenerative joint symptoms, and improving knee function in KOA patients. The combination of the two in KOA patients can significantly improve the efficacy and has a good safety profile.",2021,"After treatment, VAS scores, serum COMP, CTX-II, MMP-3, IL-1 β , TNF- α , and hs-CRP levels decreased in all three groups, and the levels of each index were as follows: joint group < treatment group 1 < treatment group 2, and the difference between any two comparisons was statistically significant.","['120 patients with KOA admitted to our hospital from June 2018 to December 2020', 'Knee osteoarthritis (KOA', 'KOA patients', 'Patients with Knee Osteoarthritis']","['Tongluozhitong Prescription-Assisted Intra-Articular Injection of Sodium Hyaluronate', 'Tongluozhitong prescription dip-soaking therapy, treatment 2 group was treated with intra-articular injection of sodium hyaluronate']","['efficacy', 'Clinical efficacy, visual analogue scale (VAS), Lysholm knee score (LKS), activity of daily living score (ADL), the levels of bone metabolic markers such as cartilage oligomeric matrix protein (COMP), type II collagen degradation maker (CTX-II), and matrix metalloproteinase-3 (MMP-3), and the levels of inflammatory mediators such as interleukin-1 β  (IL-1 β ', 'VAS Score and Knee Lysholm Score', 'LKS score and ADL score', 'clinical excellence rates', ' tumor necrosis factor- α  (TNF- α ), and hypersensitive C-reactive protein (hs-CRP', 'VAS scores, serum COMP, CTX-II, MMP-3, IL-1 β , TNF- α , and hs-CRP levels', 'adverse effects']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scoring Scale'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0601900', 'cui_str': 'COMP (Cartilage Oligomeric Matrix Protein)'}, {'cui': 'C0009331', 'cui_str': 'Collagen type II'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",120.0,0.0157636,"After treatment, VAS scores, serum COMP, CTX-II, MMP-3, IL-1 β , TNF- α , and hs-CRP levels decreased in all three groups, and the levels of each index were as follows: joint group < treatment group 1 < treatment group 2, and the difference between any two comparisons was statistically significant.","[{'ForeName': 'Jianfang', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Department of Traditional Chinese Medicine, Bethune Hospital, Taiyuan, Shanxi 030032, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Bethune Hospital, Taiyuan, Shanxi 030032, China.'}, {'ForeName': 'Mengling', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Department of Traditional Chinese Medicine, Bethune Hospital, Taiyuan, Shanxi 030032, China.'}, {'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Radiology, Bethune Hospital, Taiyuan, Shanxi 030032, China.'}, {'ForeName': 'Yinlian', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation, Bethune Hospital, Taiyuan, Shanxi 030032, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Traditional Chinese Medicine, Bethune Hospital, Taiyuan, Shanxi 030032, China.'}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Qin', 'Affiliation': 'Department of Traditional Chinese Medicine, Bethune Hospital, Taiyuan, Shanxi 030032, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/3210494']
2369,34745277,Clinical Evaluation of Pinggan Yiqi Yangshen Recipe Combined with Labetalol Hydrochloride and Magnesium Sulfate in the Treatment of PIH.,"Background


To observe the clinical effect of Pinggan Yiqi Yangshen recipe combined with labetalol hydrochloride and magnesium sulfate in the treatment of pregnancy-induced hypertension (PIH).
Methods


A total of 126 patients with PIH diagnosed in our hospital from January 2016 to May 2018 were randomly divided into the control group and the experimental group, with 63 cases in each group. The control group was treated with labetalol combined with magnesium sulfate. On the basis of the control group, the experimental group was treated with Pinggan Yiqi Yangshen recipe. Clinical efficacy, blood pressure, renal function, and biochemical indexes were compared between the two groups. Moreover, pregnancy outcomes and adverse reactions were compared between the two groups.
Results


After treatment, the total effective rate in the experimental group was higher than in the control group. Blood pressure and mean arterial pressure in the experimental group were more significantly downregulated than the control group. Renal function indexes and biochemical indexes in the experimental group were more significant than those in the control group. The incidence of cesarean section, preterm birth, and abnormal fetal heart rate in the experimental group was significantly lower than that in the control group. There was no difference in the incidence of fetal distress, postpartum hemorrhage, neonatal asphyxia, and adverse reactions between the two groups.
Conclusion


Pinggan Yiqi Yangshen recipe combined with labetalol hydrochloride and magnesium sulfate can effectively reduce the blood pressure of patients with PIH, help patients to return to normal levels of biochemical indexes and renal function indexes, and improve pregnancy outcomes with high safety, which is worthy of further promotion and application in clinical practice.",2021,"There was no difference in the incidence of fetal distress, postpartum hemorrhage, neonatal asphyxia, and adverse reactions between the two groups.
","['126 patients with PIH diagnosed in our hospital from January 2016 to May 2018', 'patients with PIH', 'pregnancy-induced hypertension (PIH']","['labetalol hydrochloride and magnesium sulfate', 'labetalol combined with magnesium sulfate', 'Pinggan Yiqi Yangshen recipe', 'Labetalol Hydrochloride and Magnesium Sulfate', 'Pinggan Yiqi']","['total effective rate', 'pregnancy outcomes and adverse reactions', 'Blood pressure and mean arterial pressure', 'Clinical efficacy, blood pressure, renal function, and biochemical indexes', 'incidence of cesarean section, preterm birth, and abnormal fetal heart rate', 'blood pressure', 'incidence of fetal distress, postpartum hemorrhage, neonatal asphyxia, and adverse reactions', 'Renal function indexes and biochemical indexes']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0852036', 'cui_str': 'Pregnancy-induced hypertension'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0699440', 'cui_str': 'Labetalol hydrochloride'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0730018', 'cui_str': 'Abnormal fetal heart rate'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring fetal status'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}]",126.0,0.0221219,"There was no difference in the incidence of fetal distress, postpartum hemorrhage, neonatal asphyxia, and adverse reactions between the two groups.
","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Health Education Department, Zhangqiu Maternity and Child Care Hospital, Jinan 250200, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Outpatient Department, Zhangqiu Maternity and Child Care Hospital, Jinan 250200, China.'}, {'ForeName': 'Peipei', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Comprehensive Ward, Zhangqiu Maternity and Child Care Hospital, Jinan 250200, China.'}, {'ForeName': 'Hongcui', 'Initials': 'H', 'LastName': 'Qu', 'Affiliation': 'Outpatient Operating Room, Zhangqiu Maternity and Child Care Hospital, Jinan 250200, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/3135043']
2370,34745223,A Novel Three-LncRNA Signature Predicting Tumor Recurrence in Nonfunctioning Pituitary Adenomas.,"The nonfunctioning pituitary adenoma (NFPA) recurrence rate is relatively high after surgical resection. Here, we constructed effective long noncoding RNA (lncRNA) signatures to predict NFPA prognosis. LncRNAs expression microarray sequencing profiles were obtained from 66 NFPAs. Sixty-six patients were randomly separated into a training ( n  = 33) and test group ( n  = 33). Univariable Cox regression and a machine learning algorithm was used to filter lncRNAs. Time-dependent receiver operating characteristic (ROC) analysis was performed to improve the prediction signature. Three lncRNAs (LOC101927765, RP11-23N2.4 and RP4-533D7.4) were included in a prognostic signature with high prediction accuracy for tumor recurrence, which had the largest area under ROC curve (AUC) value in the training/test group (AUC = 0.87/0.73). The predictive ability of the signature was validated by Kaplan-Meier survival analysis. A signature-based risk score model divied patients into two risk group, and the recurrence-free survival rates of the groups were significantly different (log-rank  p  < 0.001). In addition, the ROC analysis showed that the lncRNA signature predictive ability was significantly better than that of age in the training/testing/entire group (AUC = 0.87/0.726/0.798  vs.  AUC = 0.683/0.676/0.679). We constructed and verified a three-lncRNA signature predictive of recurrence, suggesting potential therapeutic targets for NFPA.",2021,"Three lncRNAs (LOC101927765, RP11-23N2.4 and RP4-533D7.4) were included in a prognostic signature with high prediction accuracy for tumor recurrence, which had the largest area under ROC curve (AUC) value in the training/test group (AUC = 0.87/0.73).",['Sixty-six patients'],[],"['recurrence-free survival rates', 'largest area under ROC curve (AUC) value', 'nonfunctioning pituitary adenoma (NFPA) recurrence rate', 'lncRNA signature predictive ability']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032000', 'cui_str': 'Pituitary adenoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",66.0,0.0596357,"Three lncRNAs (LOC101927765, RP11-23N2.4 and RP4-533D7.4) were included in a prognostic signature with high prediction accuracy for tumor recurrence, which had the largest area under ROC curve (AUC) value in the training/test group (AUC = 0.87/0.73).","[{'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Beijing Neurosurgical Institute, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Beijing Neurosurgical Institute, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qiuyue', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'Beijing Neurosurgical Institute, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yulou', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Beijing Neurosurgical Institute, Capital Medical University, Beijing, China.'}, {'ForeName': 'Weiyan', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Beijing Neurosurgical Institute, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yazhuo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Chuzhong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, China.'}]",Frontiers in genetics,['10.3389/fgene.2021.754503']
2371,34745566,A study protocol for the cardiac effects of a single dose of either oxytocin 2.5 IU or carbetocin 100 µg after caesarean delivery: a prospective randomized controlled multi-centre trial in Norway.,"Background : Both oxytocin and carbetocin are used to prevent uterine atony and post-partum haemorrhage after caesarean delivery in many countries, including Norway. Oxytocin causes dose-dependent ST-depression, troponin release, prolongation of QT-time and arrythmia, but little is known about myocardial effects of carbetocin. We have previously demonstrated comparable vasodilatory effects of oxytocin and carbetocin and are now undertaking a Phase 4 trial to investigate whether carbetocin causes similar changes to myocardial markers compared with oxytocin.  Methods:  Our randomized controlled trial will be conducted at three obstetrics units at Oslo University Hospital and Akershus University Hospital, Norway. Planned enrolment will be of 240 healthy, singleton pregnant women aged 18 to 50 years undergoing planned caesarean delivery. Based on pilot study data, each participant will receive a one-minute intravenous injection of either oxytocin 2.5 IU or carbetocin 100 µg during caesarean delivery. The prespecified primary outcome is the change from baseline in high-sensitive troponin I plasma concentrations at 6-10 hours after study drug administration. Secondary outcomes include uterine tone grade at 2.5 and five minutes after study drug administration, adverse events for up to 48 hours after study drug administration, estimated blood loss within eight hours of delivery, need for rescue treatment and direct/indirect costs. Enrolment and primary analysis are expected to be completed by the end of 2021.  Discussion:  Women undergoing caesarean delivery should be assessed for cardiovascular risk particularly as women with an obstetric history of pregnancy induced hypertension, gestational diabetes mellitus, preterm birth, placental abruption, and stillbirth are at increased risk of future cardiovascular disease. Any additional ischaemic myocardial risk from uterotonic agents will need to be balanced with the benefit of reducing the risk of postpartum haemorrhage. Any potential cardiotoxicity difference between oxytocin and carbetocin will help inform treatment decisions for pregnant women.  Registration:  Clinicaltrials.gov NCT03899961 (02/04/2019).",2021,"Both oxytocin and carbetocin are used to prevent uterine atony and post-partum haemorrhage after caesarean delivery in many countries, including Norway.","['three obstetrics units at Oslo University Hospital and Akershus University Hospital, Norway', '100\xa0µg after caesarean delivery', 'pregnant women', '240 healthy, singleton pregnant women aged 18 to 50 years undergoing planned caesarean delivery']","['oxytocin 2.5 IU or carbetocin', ' ', 'oxytocin and carbetocin', 'Oxytocin']","['cardiovascular risk', 'uterine tone grade at 2.5 and five minutes after study drug administration, adverse events', 'blood loss within eight hours of delivery, need for rescue treatment and direct/indirect costs', 'change from baseline in high-sensitive troponin I plasma concentrations']","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0054670', 'cui_str': 'carbetocin'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.522958,"Both oxytocin and carbetocin are used to prevent uterine atony and post-partum haemorrhage after caesarean delivery in many countries, including Norway.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bekkenes', 'Affiliation': 'Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marte Morin', 'Initials': 'MM', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Anaesthesia, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Flem Jacobsen', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Wang Fagerland', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Rakstad-Larsen', 'Affiliation': 'Division of Obstetrics and Gynaecology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ole Geir', 'Initials': 'OG', 'LastName': 'Solberg', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Aaberge', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Klingenberg', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Trude', 'Initials': 'T', 'LastName': 'Steinsvik', 'Affiliation': 'Department of Laboratory Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Leiv Arne', 'Initials': 'LA', 'LastName': 'Rosseland', 'Affiliation': 'Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.'}]",F1000Research,['10.12688/f1000research.73112.1']
2372,34745511,Segmentation of Gastric Computerized Tomography Images under Intelligent Algorithms in Evaluation of Efficacy of Decitabine Combined with Paclitaxel in Treatment of Gastric Cancer.,"To analyze the evaluation of artificial intelligence algorithm combined with gastric computed tomography (CT) image in clinical chemotherapy for advanced gastric cancer, 112 patients with advanced gastric cancer were selected as the research object. Among which, 56 patients in the experimental group received paclitaxel (PTX) combined with decitabine sequential decitabine maintenance therapy. Fifty-six patients in the control group received first-line treatment with decitabine combined with cisplatin. The image segmentation algorithm based on fast interactive dictionary selection was used to process gastric CT images. Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), response rate (RR), disease control rate (DCR), and overall survival (OS) after treatment were recorded. The true-positive rate (TPR) and coincidence ratio (CR) of the proposed algorithm for image segmentation were significantly higher than those of the mean shift algorithm and the iCoseg algorithm. The mean edge distance (MED) and edge distance variance (EDV) were significantly lower than the mean shift algorithm and the iCoseg algorithm, and the differences were considerable ( P  < 0.05). The number of CR (5 cases), PR (13 cases), RR (18 cases), and DCR (44 cases) in the experimental group was significantly higher than that in the control group, while the number of PD (12 cases) was significantly lower than that in the control group ( P  < 0.05). The number of patients complicated with hematological toxicity, leucopenia, thrombocytopenia, and digestive tract reaction in the experimental group was less than that in the control group ( P  < 0.05). From the comparison of long-term efficacy, the survival rate of patients in both groups showed a decreasing trend within 24 months, but the decreasing trend of survival rate of patients in the experimental group was better than that in the control group. In short, the proposed algorithm had better segmentation performance than traditional algorithms. Compared with first-line treatment with decitabine and cisplatin, PTX in combination with decitabine sequential citabine maintenance regimens had better disease control rates, lower toxicity, and more effective improvements in patient quality of life and longer survival in patients with advanced gastric cancer.",2021,"The mean edge distance (MED) and edge distance variance (EDV) were significantly lower than the mean shift algorithm and the iCoseg algorithm, and the differences were considerable ( P  < 0.05).","['Gastric Cancer', 'patients with advanced gastric cancer', 'advanced gastric cancer, 112 patients with advanced gastric cancer']","['artificial intelligence algorithm combined with gastric computed tomography (CT) image', 'decitabine and cisplatin, PTX', 'Decitabine Combined with Paclitaxel', 'decitabine combined with cisplatin', 'paclitaxel (PTX) combined with decitabine sequential decitabine maintenance therapy']","['mean edge distance (MED) and edge distance variance (EDV', 'true-positive rate (TPR) and coincidence ratio (CR) of the proposed algorithm for image segmentation', 'hematological toxicity, leucopenia, thrombocytopenia, and digestive tract reaction', 'survival rate', 'patient quality of life and longer survival', 'number of CR', 'number of PD', 'disease control rates, lower toxicity', 'Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), response rate (RR), disease control rate (DCR), and overall survival (OS']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",112.0,0.0428798,"The mean edge distance (MED) and edge distance variance (EDV) were significantly lower than the mean shift algorithm and the iCoseg algorithm, and the differences were considerable ( P  < 0.05).","[{'ForeName': 'Zhenghui', 'Initials': 'Z', 'LastName': 'Ge', 'Affiliation': ""Department of Gastroenterology, The People's Hospital of Danyang, Affiliated Danyang Hospital of Nantong University, Danyang 212300, Jiangsu, China.""}, {'ForeName': 'Mengyun', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Imaging, Huai'an Second People's Hospital, The Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an 223002, Jiangsu, China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Neurology, Lianshui County People's Hospital, Lianshui 223400, Jiangsu, China.""}]",Journal of healthcare engineering,['10.1155/2021/8023490']
2373,34745498,Intra-Articular Injection of PRP in the Treatment of Knee Osteoarthritis Using Big Data.,"Observing data on the characteristics of intra-articular injection of sodium citrate for knee osteoarthritis is an important reference value for human safety and evacuation design. To address the problems of slow data collection and poor accuracy of results of knee osteoarthritis behavior, under intensive conditions of intra-articular injection for knee osteoarthritis, this paper designs a data mining-based feature extraction system for intra-articular injection of sodium citrate for knee osteoarthritis. Using the Hadoop architecture, we extract the basic data of human behavior in the two-dimensional plane by storing and stitching the collected continuous data and discriminate the behavioral categories of knee osteoarthritis. We collected a real dataset from 84 patients with knee osteoarthritis treated in our hospital from October 2019 to October 2020. The dataset was divided into 42 patients in the tretinoin group and 42 patients in the sodium glutamate group according to the randomized number table method. The trimethoprim group was treated with intra-articular injection of trimethoprim, and the sodium citrate group was treated with intra-articular injection of sodium citrate. The clinical efficacy, joint mobility, intra-articular fluid volume, Lysholm score of knee joint, numerical pain intensity scale (NRS) score, and adverse effects of the two groups were compared before and after treatment. In our experiments, we observed that, compared with triamcinolone acetonide intra-articular injection, sodium hyaluronate intra-articular injection is more effective in the treatment of knee osteoarthritis. It can effectively improve knee function and reduce pain and adverse reactions.",2021,"The clinical efficacy, joint mobility, intra-articular fluid volume, Lysholm score of knee joint, numerical pain intensity scale (NRS) score, and adverse effects of the two groups were compared before and after treatment.","['knee osteoarthritis', 'group and 42 patients in the', '84 patients with knee osteoarthritis treated in our hospital from October 2019 to October 2020']","['PRP', 'trimethoprim, and the sodium citrate', 'triamcinolone acetonide intra-articular injection, sodium hyaluronate intra-articular injection', 'trimethoprim', 'sodium citrate', 'tretinoin', 'sodium glutamate']","['clinical efficacy, joint mobility, intra-articular fluid volume, Lysholm score of knee joint, numerical pain intensity scale (NRS) score, and adverse effects', 'knee function and reduce pain and adverse reactions']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0142825', 'cui_str': 'sodium citrate'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0037511', 'cui_str': 'Monosodium glutamate'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",84.0,0.0200798,"The clinical efficacy, joint mobility, intra-articular fluid volume, Lysholm score of knee joint, numerical pain intensity scale (NRS) score, and adverse effects of the two groups were compared before and after treatment.","[{'ForeName': 'Zhijin', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': ""Xingtai People's Hospital, Doctor-Patient Communication Office, Xingtai 054001, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Hebei Eye Hospital, Otolaryngology Head and Neck Surgery, Xingtai 054001, China.'}]",Journal of healthcare engineering,['10.1155/2021/4504155']
2374,34745397,Beneficial Effects of Kiatsu™ with Ki Training on Episodic Migraine: An Exploratory Study.,"Objective


To conduct an exploratory study of Kiatsu TM  with Ki training as a potential therapy for treating episodic migraine in women.
Background


Current therapies for migraine have proven partially effective, highlighting the need for alternative treatment options. In preparation for development of a randomized controlled study, the authors conducted a single arm pilot exploratory study to evaluate the effect of Kiatsu with Ki training in adult females with episodic migraine.
Methods


Study subjects established a baseline migraine frequency over 4 weeks. During the following 4 weeks, each subject received instruction in Ki training (to improve concentration, balance, and relaxation), accompanied by Kiatsu (a focused touch method that reduces tension, swelling, and pain). Subjects then participated in one session a month for additional 6 months. The initial session was 1 hour; subsequent sessions averaged 30 minutes. Subjects documented migraine frequency, migraine-specific quality of life scores, and medication use.
Result


Sixty-nine subjects met the study inclusion criteria, and 21 completed the study. Subjects reported a significant reduction in migraine frequency after 1 month (from 7.2 to 3.8 migraines/month;  p  < 0.05), with an overall 53% reduction at 6 months ( p  < 0.001). Significant improvements in quality of life (QoL) were reported after 1 month, with continued improvements until study completion ( p  < 0.0001). A moderate reduction in medication use was also documented ( p  < 0.03), corresponding to improved QoL scores.
Conclusion


Kiatsu with Ki training may be an effective treatment option for females with migraines, either in combination with medications or as a potential alternative to medications for patients who do not benefit from conventional therapies. The results of this pilot study justify the development of a randomized controlled study designed to investigate the potential benefits of this novel therapeutic method for treating migraine.",2021,"Subjects reported a significant reduction in migraine frequency after 1 month (from 7.2 to 3.8 migraines/month;  p  < 0.05), with an overall 53% reduction at 6 months ( p  < 0.001).","['treating episodic migraine in women', 'Episodic Migraine', 'Result\n\n\nSixty-nine subjects met the study inclusion criteria, and 21 completed the study', 'females with migraines', 'adult females with episodic migraine']","['Kiatsu™ with Ki Training', 'Kiatsu TM  with Ki training', 'Kiatsu with Ki training', 'instruction in Ki training', 'Ki training']","['baseline migraine frequency', 'quality of life (QoL', 'migraine frequency, migraine-specific quality of life scores, and medication use', 'migraine frequency', 'QoL scores']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",69.0,0.0259709,"Subjects reported a significant reduction in migraine frequency after 1 month (from 7.2 to 3.8 migraines/month;  p  < 0.05), with an overall 53% reduction at 6 months ( p  < 0.001).","[{'ForeName': 'Calvin Y', 'Initials': 'CY', 'LastName': 'Tabata', 'Affiliation': 'Oregon Ki Society, Tigard, OR, USA.'}, {'ForeName': 'Philip F', 'Initials': 'PF', 'LastName': 'Copenhaver', 'Affiliation': 'Oregon Ki Society, Tigard, OR, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'McCartney', 'Affiliation': 'Oregon Ki Society, Tigard, OR, USA.'}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Vazinkhoo', 'Affiliation': 'Oregon Ki Society, Tigard, OR, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Copperman', 'Affiliation': 'Oregon Ki Society, Tigard, OR, USA.'}]",Pain research & management,['10.1155/2021/3290879']
2375,34745861,Effect of antibiotic pack on hard palate after fistula closure on nasal airflow and reoccurrence rate.,"This parallel blocked randomized controlled trial was done in two groups of 30 patients each to determine if placement of an antibiotic oral pack on the hard palate after hard palatal fistula repair reduces nasal air emission and fistula re-occurrence. Group A had an oral pack on the hard palate for 5 days post-operatively while group B did not. In group A, percentage of nasal air emission was tested using nasometry with and without pack. Paired t-tests were performed to compare nasal emissions for patients with and without pack. Recurrence of fistulas after 6 months between group A and B was tested using odds ratio. Effect of nasal air emission on fistula rates was tested using paired t-tests. There was a significant increase (p < 0.0001) in nasal emission after removal of the pack in group A. Fistula re-occurrence tended to be higher in group B (no pack) than group A but this was not significant (p = 0.242). There was no correlation between nasal air emission and fistula rates. In patients with recurrent fistulae, placement of an oral pack after fistula repair diminishes nasal air emission. Whether this has an impact on re-occurrence of fistulae needs to be investigated further.",2022,There was a significant increase (p < 0.0001) in nasal emission after removal of the pack in group A. Fistula re-occurrence tended to be higher in group B (no pack) than group A,"['two groups of 30 patients each to determine if placement of an antibiotic oral pack on the hard palate after hard palatal fistula repair reduces nasal air emission and fistula re-occurrence', 'patients with recurrent fistulae, placement of an oral pack after fistula repair diminishes nasal air emission']","['antibiotic pack', 'nasal air emission']","['Recurrence of fistulas', 'nasal emission', 'nasal air emission and fistula rates', 'nasal airflow and reoccurrence rate', 'nasal emissions', 'fistula rates', 'percentage of nasal air emission']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0226901', 'cui_str': 'Hard palate structure'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0441508', 'cui_str': 'Fistula repair'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0234848', 'cui_str': 'Nasal air emission'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0234848', 'cui_str': 'Nasal air emission'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0234848', 'cui_str': 'Nasal air emission'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.0330572,There was a significant increase (p < 0.0001) in nasal emission after removal of the pack in group A. Fistula re-occurrence tended to be higher in group B (no pack) than group A,"[{'ForeName': 'Rajgopal R', 'Initials': 'RR', 'LastName': 'Reddy', 'Affiliation': 'Cranio-maxillofacial Surgery, G.S.R. Hospital, Institute of Cranio-Maxillofacial and Facial Plastic Surgery, Vinay Nagar Colony, Saidabad, Hyderabad, India.'}, {'ForeName': 'Srinivas Gosla', 'Initials': 'SG', 'LastName': 'Reddy', 'Affiliation': 'Cranio-maxillofacial Surgery, G.S.R. Hospital, Institute of Cranio-Maxillofacial and Facial Plastic Surgery, Vinay Nagar Colony, Saidabad, Hyderabad, India.'}, {'ForeName': 'Avni', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'G.S.R. Hospital, Institute of Cranio-Maxillofacial and Facial Plastic Surgery, Vinay Nagar Colony, Saidabad, Hyderabad, India.'}, {'ForeName': 'Bhavya', 'Initials': 'B', 'LastName': 'Banala', 'Affiliation': 'Speech and Language Therapy,G.S.R. Hospital, Institute of Cranio-Maxillofacial and Facial Plastic Surgery, Vinay Nagar Colony, Saidabad, Hyderabad, India.'}, {'ForeName': 'Ewald M', 'Initials': 'EM', 'LastName': 'Bronkhorst', 'Affiliation': 'Department of Cariology and Preventive Dentistry, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Kuijpers-Jagtman', 'Affiliation': 'Department of Orthodontics, University Medical Centre Groningen Groningen, the Netherlands.'}]",Journal of oral biology and craniofacial research,['10.1016/j.jobcr.2021.09.009']
2376,34745860,"A randomized, double-blind, split-mouth controlled clinical trial of systemically administered Lycopene on periodontal health.","Background/Purpose


This research aimed to compare the effects of systemically prescribed Lycopene as a monotherapy and as an alternative to scaling and root planing in patients with chronic gingivitis.
Materials and methods


The participants were randomly assigned to one of two treatment groups: the experimental group (n = 50), which received 10 mg of Lycopene a day for two weeks, or the control group (n = 50) received a placebo for two weeks. For each category, quadrant distribution was randomized, with two quadrants receiving oral prophylaxis (OP) and two quadrants receiving no care (non-OP). At baseline, 1st, and 2nd weeks, the sulcus bleeding index, plaque index, gingival index, and salivary uric acid level were measured.
Results


All clinical criteria, including SBI, PI, GI, and salivary uric acid levels, showed a statistically significant decline in all patient types. Both clinical parameters were significantly reduced (p < 0.001) in the OP-lycopene group relative to the non-OP-placebo group and non-OP lycopene group (p < 0.05). The PI value in the OP-lycopene group was statistically significantly lower (p < 0.001) than in the non-OP-placebo group; there was no statistically significant difference in the other groups. Salivary uric acid levels in the OP- and non-OP- lycopene groups were significantly lower (p < 0.001) than in the non-OP-placebo population.
Conclusion


Based on the findings of this study, Lycopene seems to have a bright future as a treatment option for plaque-induced generalized chronic marginal gingivitis. More research with a broad sample size and multicentre trials is required.
Clinical relevance


The article reveals the positive relationship between Lycopene and gingivitis. The analysis shows that a combination of systemically administered Lycopene with oral prophylaxis can be a valuable tool in treating chronic gingivitis and controlling respiratory oxidative stress.",2022,The PI value in the OP-lycopene group was statistically significantly lower (p < 0.001) than in the non-OP-placebo group; there was no statistically significant difference in the other groups.,['patients with chronic gingivitis'],"['Lycopene', 'oral prophylaxis (OP) and two quadrants receiving no care (non-OP', 'placebo', '10\xa0mg of Lycopene']","['Salivary uric acid levels', 'periodontal health', 'sulcus bleeding index, plaque index, gingival index, and salivary uric acid level', 'PI value', 'SBI, PI, GI, and salivary uric acid levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.3794,The PI value in the OP-lycopene group was statistically significantly lower (p < 0.001) than in the non-OP-placebo group; there was no statistically significant difference in the other groups.,"[{'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Dept. of Periodontology, Mithila Minority Dental College and Hospital, India.'}, {'ForeName': 'Anootpal', 'Initials': 'A', 'LastName': 'Gogoi', 'Affiliation': 'Dept. of Periodontology, Regional Dental College, Guwahati, Assam, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Dept. of Public Health Dentistry, Baba Jaswant Singh Dental College & Hospital, Ludhiana, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Eesha', 'Affiliation': 'Dept. of Oral Pathology, Regional Dental College, Guwahati, Assam, India.'}, {'ForeName': 'Rinku', 'Initials': 'R', 'LastName': 'Jagnade', 'Affiliation': 'Dept. of Periodontology, Index Institute of Dental Sciences and Research Center, Indore, MP, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Jain', 'Affiliation': 'Dept. of Conservative Dentistry and Endodontics, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Rastogi', 'Affiliation': 'Dept. of Oral and Maxillofacial Surgery, Regional Dental College, Bhangagarh Guwahati, Assam, 781032, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Dept. of Oral Medicine and Radiology, Regional Dental College, Bhangagarh Guwahati, Assam, 781032, India.'}]",Journal of oral biology and craniofacial research,['10.1016/j.jobcr.2021.09.020']
2377,34745697,Immune Function following Major Spinal Surgery and General Anesthesia.,"There are reported differences in the effects that general anesthetics may have on immune function after minor surgery. To date, there are no prospective trials comparing total intravenous anesthesia (TIVA) with a volatile agent-based technique and its effects on immune function after major spinal surgery in adolescents. Twenty-six adolescents undergoing spinal fusion were randomized to receive TIVA with propofol-remifentanil or a volatile agent-based technique with desflurane-remifentanil. Immune function measures were based on the antigen-presenting and cytokine production capacity, and relative proportions of cell populations. Overall characteristics of the two groups did not differ in terms of perioperative times, hemodynamics, or fluid shifts, but those treated with propofol had lower bispectral index values. Experimental groups had relatively high baseline interleukin-10 values, but both showed a significant inflammatory response with similar changes in their respective immune functions. This included a shift toward a granulocytic predominance; a transient reduction in monocyte markers with significant decrease in antigen-presenting capacity and cytokine production capacity. Anesthetic choice does not appear to differentially impact immune function, but exposure to anesthetics and surgical trauma results in reproducibly measurable suppression of both innate and adaptive immunity in adolescents undergoing posterior spinal fusion. The magnitude of this suppression was modest when compared with pediatric and adult patients with critical illnesses. This study highlighted the need to evaluate immune function in a broader population of surgical patients with higher severity of illness.",2021,"Overall characteristics of the two groups did not differ in terms of perioperative times, hemodynamics, or fluid shifts, but those treated with propofol had lower bispectral index values.","['adolescents undergoing posterior spinal fusion', 'Twenty-six adolescents undergoing spinal fusion', 'after major spinal surgery in adolescents', 'surgical patients with higher severity of illness', 'Major Spinal Surgery and General Anesthesia']","['total intravenous anesthesia (TIVA) with a volatile agent-based technique', 'propofol', 'TIVA with propofol-remifentanil or a volatile agent-based technique with desflurane-remifentanil']","['Immune function measures', 'bispectral index values', 'baseline interleukin-10 values', 'immune function', 'perioperative times, hemodynamics, or fluid shifts', 'Immune Function']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}]","[{'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0242705', 'cui_str': 'Fluid Shifts'}]",26.0,0.0544788,"Overall characteristics of the two groups did not differ in terms of perioperative times, hemodynamics, or fluid shifts, but those treated with propofol had lower bispectral index values.","[{'ForeName': 'Lance M', 'Initials': 'LM', 'LastName': 'Relland', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, Ohio, United States.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': ""Center for Clinical and Translational Research, Nationwide Children's Hospital, Columbus, Ohio, United States.""}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Martin', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, Ohio, United States.""}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Nateri', 'Affiliation': ""Center for Clinical and Translational Research, Nationwide Children's Hospital, Columbus, Ohio, United States.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hanson-Huber', 'Affiliation': ""Center for Clinical and Translational Research, Nationwide Children's Hospital, Columbus, Ohio, United States.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Beebe', 'Affiliation': ""Department of Orthopedic Surgery, Nationwide Children's Hospital, Columbus, Ohio, United States.""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Samora', 'Affiliation': ""Department of Orthopedic Surgery, Nationwide Children's Hospital, Columbus, Ohio, United States.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klamar', 'Affiliation': ""Department of Orthopedic Surgery, Nationwide Children's Hospital, Columbus, Ohio, United States.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Muszynski', 'Affiliation': ""Center for Clinical and Translational Research, Nationwide Children's Hospital, Columbus, Ohio, United States.""}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tobias', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, Ohio, United States.""}]",Journal of pediatric intensive care,['10.1055/s-0040-1716668']
2378,34746084,36-Month Evaluation of a Weight Management Programme in Chinese Overweight and Obese Adults.,"Background:  Few comprehensive lifestyle intervention programmes have been investigated on overweight and obese adults in China. This study was to evaluate the effect of a 36-month weight management programme on weight loss and its maintenance among overweight and obese patients in Ningbo, China.  Methods:  Adults with BMI ≥24 kg / m   2  enrolled in this programme, including nutritional, physical activity, psychological and endocrinological counselling sessions, from July 2015 to January 2020. Adults participated in face-to-face counselling sessions and group-based education. Then, participants joined 21-day intensive programme using Bohe health APP and WeChat group to get personal advice of nutrition and lifestyle. In the end, participants were requested to join 33-month follow-ups including face-to-face counselling and personal advice on WeChat group. The main outcome was to evaluate the changes in weight at each followup from baseline weight.  Results:  In total, 692 adults participated in this entire weight management programme. During follow-ups, 579, 475, 299, 219, and 135 adults participated at 3, 6, 12, 24, and 36 months, respectively. All participants had a significant initial weight loss at 3 months, then maintained the weight loss during 33-month follow-ups. At 36 months, 11.0%, 6.4%, and 3.5% of all participants achieved 5%, 10%, and 15% weight loss from the baseline weight, respectively. Adjusted weight at 36 months was significantly reduced from the baseline weight in both sex (-7.2 kg).  Conclusion:  This weight management programme is suggested to benefit to reduce initial body weight and maintain long-term weight loss among overweight and obese adults.",2021,Adjusted weight at 36 months was significantly reduced from the baseline weight in both sex (-7.2 kg).  ,"['overweight and obese adults in China', 'Adults participated in face-to-face counselling sessions and group-based education', 'Chinese Overweight and Obese Adults', '692 adults participated in this entire weight management programme', 'overweight and obese patients in Ningbo, China', 'Adults with BMI ≥24 kg / m   2  enrolled in this programme, including nutritional, physical activity, psychological and endocrinological counselling sessions, from July 2015 to January 2020', 'overweight and obese adults']","['Weight Management Programme', 'weight management programme', 'health APP and WeChat group to get personal advice of nutrition and lifestyle']","['Adjusted weight', 'weight loss', 'changes in weight', 'initial weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",692.0,0.0642461,Adjusted weight at 36 months was significantly reduced from the baseline weight in both sex (-7.2 kg).  ,"[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Nutrition, Ningbo First Hospital, Ningbo, China.'}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Chattopadhyay', 'Affiliation': 'Division of Epidemiology and Public Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hubbard', 'Affiliation': 'Division of Epidemiology and Public Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Jia-Lin', 'Initials': 'JL', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology and Metabolism, Ningbo First Hospital, Ningbo, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology and Metabolism, Ningbo First Hospital, Ningbo, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Center for Health Economics, Faculty of Humanities and Social Sciences, University of Nottingham, Ningbo, China.'}]",Frontiers in public health,['10.3389/fpubh.2021.749302']
2379,34746040,Optimal Timing of Simethicone Supplement for Bowel Preparation: A Prospective Randomized Controlled Trial.,"Background and Aims


Simethicone (SIM), as an antifoaming agent, has been shown to improve bowel preparation during colonoscopy. However, the optimal timing of SIM addition remained undetermined. We aimed to investigate the optimal timing of SIM addition to polyethylene glycol (PEG) to improve bowel preparation.
Methods


Eligible patients were randomly assigned to two groups: the SIM evening group (SIM addition to PEG in the evening of the day prior to colonoscopy) and the SIM morning group (SIM addition to PEG in the morning of colonoscopy). The primary outcome was Bubble Scale (BS). The secondary outcomes were Boston Bowel Preparation Scale (BBPS) and adenoma detection rate (ADR).
Results


A total of 419 patients were enrolled in this study. The baseline characteristics of the patients were similar in both groups. No significant differences were observed in terms of BS (8.76 ± 0.90 vs. 8.65 ± 1.16,  P  = 0.81), ADR (34.1% vs. 30.8%,  P  = 0.47), Boston Bowel Preparation Scale (BBPS) (8.59 ± 0.94 vs. 8.45 ± 1.00,  P  = 0.15), and withdrawal time (8.22 ± 2.04 vs. 8.01 ± 2.51,  P  = 0.094) between the two groups. Moreover, safety and compliance were similar in both groups. However, the SIM evening group was associated with shorter cecal intubation time (3.80 ± 1.81 vs. 4.42 ± 2.03,  P  < 0.001), higher BS (2.95 ± 0.26 vs. 2.88 ± 0.38,  P  = 0.04) in the right colon, and diminutive ADR (62.5% vs. 38.6%,  P  = 0.022) in the right colon, when compared to the SIM evening group.
Conclusions


The SIM addition to PEG in the evening of the day prior to colonoscopy can shorten cecal intubation time and improve BS scores and diminutive ADR of the right colon compared with the SIM addition to PEG in the morning of colonoscopy in bowel preparation.",2021,"No significant differences were observed in terms of BS (8.76 ± 0.90 vs. 8.65 ± 1.16,  P  = 0.81), ADR (34.1% vs. 30.8%,  P  = 0.47), Boston Bowel Preparation Scale (BBPS) (8.59 ± 0.94 vs. 8.45 ± 1.00,  P  = 0.15), and withdrawal time (8.22 ± 2.04 vs. 8.01 ± 2.51,  P  = 0.094) between the two groups.","['Bowel Preparation', '419 patients were enrolled in this study']","['SIM addition to polyethylene glycol (PEG', 'SIM evening group (SIM addition to PEG in the evening of the day prior to colonoscopy) and the SIM morning group (SIM addition to PEG in the morning of colonoscopy', 'Simethicone Supplement']","['shorter cecal intubation time', 'safety and compliance', 'cecal intubation time and improve BS scores', 'Bubble Scale (BS', 'ADR', 'Boston Bowel Preparation Scale (BBPS', 'withdrawal time', 'BS', 'Boston Bowel Preparation Scale (BBPS) and adenoma detection rate (ADR']","[{'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037138', 'cui_str': 'Simethicone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",419.0,0.0336472,"No significant differences were observed in terms of BS (8.76 ± 0.90 vs. 8.65 ± 1.16,  P  = 0.81), ADR (34.1% vs. 30.8%,  P  = 0.47), Boston Bowel Preparation Scale (BBPS) (8.59 ± 0.94 vs. 8.45 ± 1.00,  P  = 0.15), and withdrawal time (8.22 ± 2.04 vs. 8.01 ± 2.51,  P  = 0.094) between the two groups.","[{'ForeName': 'Zhen-Wen', 'Initials': 'ZW', 'LastName': 'Wu', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Sheng-Gang', 'Initials': 'SG', 'LastName': 'Zhan', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Mei-Feng', 'Initials': 'MF', 'LastName': 'Yang', 'Affiliation': ""Department of Hematology, Yantian District People's Hospital, Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Yi-Teng', 'Initials': 'YT', 'LastName': 'Meng', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xiong', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Ying-Xue', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Ding-Guo', 'Initials': 'DG', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Zheng-Lei', 'Initials': 'ZL', 'LastName': 'Xu', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Ben-Hua', 'Initials': 'BH', 'LastName': 'Wu', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Rui-Yue', 'Initials': 'RY', 'LastName': 'Shi', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'Li-Sheng', 'Initials': 'LS', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}, {'ForeName': 'De-Feng', 'Initials': 'DF', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, (The Second Clinical Medical College, Jinan University), Shenzhen 518020, Guangdong, China.""}]",Canadian journal of gastroenterology & hepatology,['10.1155/2021/4032285']
2380,34745923,"Comparing the effects of saffron, lippia, and saffron-lippia combination on anxiety among candidates for coronary angiography.","Objective


Coronary artery disease (CAD) is among the most prevalent diseases in the world, and its severity is usually assessed through coronary angiography (CA). Anxiety is the most prevalent problem before angiography. The aim of this study was to evaluate  Crocus sativus  (saffron) and  Lippia citriodora  Kunth (lippia) extracts and saffron-lippia extract combination on anxiety among the candidates for CA.
Materials and Methods


This double-blind randomized placebo-controlled trial in four month was conducted on 120 angiography candidates in Valiasr hospital, Birjand, Iran. The random allocation was doing through block randomization to saffron, lippia, saffron-lippia, and placebo groups; four hours before angiography, participants in these groups respectively received a single dose of saffron extract capsule (40 mg), lippia extract capsule (40 mg), saffron-lippia extract capsule (20 mg saffron and 20 mg lippia), and lactulose capsule (40 mg). Participants' anxiety was assessed before, thirty minutes after, and three hours after the intervention via Spielberger State-Trait Anxiety Inventory.
Results


The mean scores of state, trait, and total anxiety in the saffron group reduced significantly (p<0.05), while the mean scores in the other groups did not change significantly, except for the mean score of trait anxiety in the saffron-lippia group which decreased significantly (p=0.05). Therefore, after the intervention, the mean scores of state, trait, and total anxiety in the saffron group were significantly lower than the other groups (all, p<0.05).
Conclusion


This study suggests that the oral use of a single-dose of 40 mg saffron extract is effective in alleviating anxiety among the candidates for CA.",2021,"The mean scores of state, trait, and total anxiety in the saffron group reduced significantly (p<0.05), while the mean scores in the other groups did not change significantly, except for the mean score of trait anxiety in the saffron-lippia group which decreased significantly (p=0.05).","['120 angiography candidates in Valiasr hospital, Birjand, Iran', 'anxiety among candidates for coronary angiography']","['saffron extract', 'saffron, lippia, and saffron-lippia combination', 'Crocus sativus  (saffron) and  Lippia citriodora  Kunth (lippia) extracts and saffron-lippia extract combination', 'saffron extract capsule (40 mg), lippia extract capsule (40 mg), saffron-lippia extract capsule (20 mg saffron and 20 mg lippia), and lactulose capsule', 'placebo']","['mean score of trait anxiety', 'alleviating anxiety', 'mean scores of state, trait, and total anxiety']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C3696061', 'cui_str': 'Saffron Extract'}, {'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0331283', 'cui_str': 'Lippia'}, {'cui': 'C0946614', 'cui_str': 'Saffron Crocus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",120.0,0.0861376,"The mean scores of state, trait, and total anxiety in the saffron group reduced significantly (p<0.05), while the mean scores in the other groups did not change significantly, except for the mean score of trait anxiety in the saffron-lippia group which decreased significantly (p=0.05).","[{'ForeName': 'Kobra', 'Initials': 'K', 'LastName': 'Soheilipur', 'Affiliation': 'Faculty of Nursing and Midwifery, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khazdair', 'Affiliation': 'Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Seyyed Ali', 'Initials': 'SA', 'LastName': 'Moezi', 'Affiliation': 'Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Gholamhossein', 'Initials': 'G', 'LastName': 'Mahmoudirad', 'Affiliation': 'Faculty of Nursing and Midwifery, Birjand University of Medical Sciences, Birjand, Iran.'}]",Avicenna journal of phytomedicine,['10.22038/AJP.2021.18077']
2381,34745918,Squill oil for decreasing dyspareunia and increasing sexual satisfaction in menopausal women: A triple-blind randomized controlled trial.,"Objective


The present study aimed to investigate the effect of squill oil on dyspareunia and sexual satisfaction in menopausal women.
Materials and Methods


The present triple-blind randomized two-group controlled trial was conducted on 60 menopausal women (n=30 in placebo group and n=30 in squill oil group) in Mashhad in northeast of Iran in 2019. The Sabbatsberg Sexual Self-Rating Scale and Marinoff dyspareunia scale were the main tools used in this study. The participants were randomly assigned to two groups namely, squill oil group and placebo group and they received the treatments for 4 weeks. Questionnaires were completed before and 4 weeks after the intervention in both groups. Data analysis was performed using SPSS 24 by Mann-Whitney, t-test, and repeated measures ANOVA with a significance level of less than 0.05.
Results


The average age in the squill oil group and placebo group were 53.5±2.2 and 51.7±4.5 years, respectively. There was a significant difference (p<0.001) between the two groups in terms of dyspareunia score before (1±3.6 vs 1±3.5) and after intervention (0.7±0.1 vs 1.2±1.2) in two groups.Results of independent t-test indicated that there was a significant difference (p<0.001) between the two groups in terms of sexual satisfaction before (23.4±5.7 vs 23.1±2.8) and after intervention (36.5±5.6 vs 24.8±2.5) in two groups.
Conclusion


Using squill oil can cause a reduction in painful sexual intercourse and an increase in sexual satisfaction in postmenopausal women.",2021,There was a significant difference (p<0.001) between the two groups in terms of dyspareunia score before (1±3.6 vs 1±3.5) and after intervention (0.7±0.1 vs 1.2±1.2) in two groups.,"['menopausal women', '60 menopausal women (n=30 in placebo group and n=30 in squill oil group) in Mashhad in northeast of Iran in 2019', 'postmenopausal women']","['squill oil group and placebo', 'placebo', 'Squill oil', 'squill oil']","['painful sexual intercourse', 'dyspareunia', 'dyspareunia and sexual satisfaction', 'Sabbatsberg Sexual Self-Rating Scale and Marinoff dyspareunia scale', 'dyspareunia score', 'sexual satisfaction']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0305070', 'cui_str': 'Squill extract'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0305070', 'cui_str': 'Squill extract'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.133922,There was a significant difference (p<0.001) between the two groups in terms of dyspareunia score before (1±3.6 vs 1±3.5) and after intervention (0.7±0.1 vs 1.2±1.2) in two groups.,"[{'ForeName': 'Farzane', 'Initials': 'F', 'LastName': 'Karimi', 'Affiliation': 'Department of Midwifery, Birjand branch, Islamic Azad University, Birjand, Iran.'}, {'ForeName': 'Raheleh', 'Initials': 'R', 'LastName': 'Babazadeh', 'Affiliation': 'Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Zojaji', 'Affiliation': 'Department of Medicine, Mashhad branch, Islamic Azad University, Mashhad, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Jouya', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Avicenna journal of phytomedicine,['10.22038/AJP.2021.17777']
2382,34746258,Design of a Randomized Placebo-Controlled Trial to Evaluate the Anti-inflammatory and Senolytic Effects of Quercetin in Patients Undergoing Coronary Artery Bypass Graft Surgery.,"Background:  Following an acute coronary syndrome, patients display an elevated inflammatory profile, promoted in part by cellular senescence. For patients requiring a coronary artery bypass (CABG) surgery, exposure to the surgical intervention and cardiopulmonary bypass further exacerbate their residual inflammation. Experimental evidence identified quercetin, a natural senolytic drug, as a cardioprotective agent against inflammatory injuries. The Q-CABG study aims to explore the efficacy of quercetin to reduce inflammation, myocardial injury and senescence in patients undergoing CABG following an acute coronary syndrome.  Methods:  Q-CABG is a phase II, prospectively registered, randomized, double-blind and placebo-controlled clinical trial. Recruited patients awaiting CABG surgery at the Montreal Heart Institute (n = 100) will be randomly assigned in a 1:1 ratio to receive either quercetin supplementation (500 mg twice daily) or placebo, starting 2 days before surgery and until the seventh postoperative day. The primary endpoint examines the effects of quercetin on blood inflammatory cytokines and markers of myocardial injury and senescence in this patient population. Blood samples will be taken at four time points: baseline, postoperative day 1, postoperative day 4 and at hospital discharge, or after a maximum of seven postoperative days. The secondary endpoint is the assessment of endothelial (dys) function by looking at  ex vivo  vascular reactivity and mRNA expression of endothelial cells from the wall of discarded segments of internal mammary artery.  Discussion:  The preventive intake of quercetin supplementation may help limit the vigorous inflammatory response triggered by CABG and subsequent postoperative complications in patients suffering from an acute coronary syndrome. In an exploratory way, quercetin supplementation could also improve endothelial function by eliminating senescent vascular endothelial cells. The results of this trial should provide valuable information regarding a novel approach to improve biological, and potentially clinical, outcomes post CABG.  Clinical Trial Registration:  ClinicalTrials.gov, Identifier NCT04907253.",2021,The primary endpoint examines the effects of quercetin on blood inflammatory cytokines and markers of myocardial injury and senescence in this patient population.,"['patients undergoing CABG following an acute coronary syndrome', 'patients requiring a coronary artery bypass (CABG) surgery, exposure to the surgical intervention and cardiopulmonary bypass further exacerbate their residual inflammation', 'acute coronary syndrome', 'Recruited patients awaiting CABG surgery at the Montreal Heart Institute (n = 100', 'Patients Undergoing Coronary Artery Bypass Graft Surgery', 'patients suffering from an acute coronary syndrome']","['Placebo', 'quercetin', 'Quercetin', 'placebo', 'quercetin supplementation']","['inflammation, myocardial injury and senescence', 'endothelial function', 'blood inflammatory cytokines and markers of myocardial injury and senescence', 'assessment of endothelial (dys) function by looking at  ex vivo  vascular reactivity and mRNA expression of endothelial cells from the wall of discarded segments of internal mammary artery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}]",100.0,0.444976,The primary endpoint examines the effects of quercetin on blood inflammatory cytokines and markers of myocardial injury and senescence in this patient population.,"[{'ForeName': 'Olina', 'Initials': 'O', 'LastName': 'Dagher', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Mury', 'Affiliation': 'Research Centre, Montreal Heart Institute, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Pierre-Emmanuel', 'Initials': 'PE', 'LastName': 'Noly', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Annik', 'Initials': 'A', 'LastName': 'Fortier', 'Affiliation': 'Montreal Health Innovations Coordinating Center, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lettre', 'Affiliation': 'Research Centre, Montreal Heart Institute, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Thorin', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Université de Montréal, Montreal, QC, Canada.'}]",Frontiers in cardiovascular medicine,['10.3389/fcvm.2021.741542']
2383,34746234,Creation of a Novel Nomogram Based on the Direct Bilirubin-To-Indirect Bilirubin Ratio and Lactate Dehydrogenase Levels in Resectable Colorectal Cancer.,"Background:  Recently, many studies have suggested that bilirubin is associated with the prognosis of colorectal cancer (CRC). Conversely, there is substantial evidence that lactate dehydrogenase (LDH) levels are associated with the prognosis of cancer. Therefore, we sought to find a novel marker based on the above to predict prognosis in patients with resectable CRC.  Methods:  A total of 702 patients from Hubei Cancer Hospital were included. The whole population was randomly divided into training ( n  = 491) and testing ( n  = 211) cohorts. Next, we established a new index based on direct bilirubin, indirect bilirubin and LDH levels. Chi-square tests, Kaplan-Meier survival analyses, and Cox regression analyses were used to evaluate prognosis. The prediction accuracies of models for overall survival (OS) and disease-free survival (DFS) were estimated through Harrell's concordance index (C-index) and the Brier score.  Results:  The median DFS duration was 32 months (range: 0-72.6 months), whereas the median OS duration was 35 months (range: 0 months-73.8 months). In addition, a new indicator, (DIR.LDH) (HR: 1.433; 95% CI, 1.069-1.920) could independently predict outcomes in CRC patients. Moreover, the module based on DIR. LDH was found to have exceptional performance for predicting OS and DFS. The C-index of the nomogram for OS was 0.802 (95% CI, 0.76-0.85) in the training cohort and 0.829 (95% CI, 0.77-0.89) in the testing cohort. The C-index of the nomogram for DFS was 0.774 (95% CI, 0.74-0.81) in the training cohort and 0.775 (95% CI, 0.71-0.84) in the testing cohort.  Conclusion:  We successfully established a novel module to guide clinical decision-making for CRC.",2021,The C-index of the nomogram for DFS was 0.774,"['patients with resectable CRC', '702 patients from Hubei Cancer Hospital were included', 'Resectable Colorectal Cancer']","['LDH', 'new indicator, (DIR.LDH']","['median OS duration', 'overall survival (OS) and disease-free survival (DFS', 'direct bilirubin, indirect bilirubin and LDH levels', 'Direct Bilirubin-To-Indirect Bilirubin Ratio and Lactate Dehydrogenase Levels', 'median DFS duration', 'lactate dehydrogenase (LDH) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0201916', 'cui_str': 'Bilirubin, direct measurement'}, {'cui': 'C0301719', 'cui_str': 'Indirect reacting bilirubin'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}]",702.0,0.167311,The C-index of the nomogram for DFS was 0.774,"[{'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Gastrointestinal Oncology Surgery, Hubei Cancer Hospital, Wuhan, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Colorectal Cancer Clinical Research Center of Hubei Province, Wuhan, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Colorectal Cancer Clinical Research Center of Hubei Province, Wuhan, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Colorectal Cancer Clinical Research Center of Hubei Province, Wuhan, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Colorectal Cancer Clinical Research Center of Hubei Province, Wuhan, China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Gastrointestinal Oncology Surgery, Hubei Cancer Hospital, Wuhan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Gastrointestinal Oncology Surgery, Hubei Cancer Hospital, Wuhan, China.'}, {'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Colorectal Cancer Clinical Research Center of Hubei Province, Wuhan, China.'}, {'ForeName': 'Shaozhong', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Department of Gastrointestinal Oncology Surgery, Hubei Cancer Hospital, Wuhan, China.'}]",Frontiers in molecular biosciences,['10.3389/fmolb.2021.751506']
2384,34746225,Intranasal Dexmedetomidine Accompanied by Cartoon Video Preoperation for Reducing Emergence Delirium in Children Undergoing Strabismus Surgery: A Prospective Randomized Trial.,"Background:  After general anesthesia, many pediatric patients present with emergence delirium (ED). The aim of this study was to determine whether dexmedetomidine intranasal premedication accompanied by a cartoon video 30 min before general anesthesia would have an effect on reducing emergence delirium in preschool children.  Methods:  One hundred and forty children aged 3-6 year undergoing elective strabismus surgery were randomly to be premedicated with 2 μg kg -1  intranasal dexmedetomidine accompanied by the viewing of a cartoon video (Group DV) or without any premedication as usual (Group C). The primary outcome was the incidence of emergence delirium at the postanesthesia care unit (PACU), evaluated by the Pediatric Anesthesia Emergence Delirium (PAED) scale. The secondary outcomes included: the Modified Yale Preoperative Anxiety Scale (mYPAS) upon separation from parents; the Induction Compliance Checklist score (ICC); the PACU discharge time; the parental satisfaction score; the incidences of the side effects and the Post-Hospital Behavior Questionnaire (PHBQ) score during the first day after surgery.  Results:  The incidence of emergence agitation (PAED score ≥ 10) was reduced in Group DV compared with Group C [8 (11.4%) vs. 24 (34.3%);  P  = 0.001]. None of the patients in the DV group experienced severe emergence agitation (PAED score ≥ 15), as compared with the C group ( P  = 0.006). The mYPAS score upon separation from parents ( P  < 0.001) and the incidence of poor coordination (ICC ≥ 4) during induction ( P  < 0.001) were significantly lower in Group DV than in Group C. In Group DV, the PACU discharge time was longer ( P  < 0.001), and the parental satisfaction score was higher ( P  < 0.001). However, during the first day after surgery, the PHBQ score was lower in Group DV compared with Group C ( P  = 0.001).  Conclusions:  Premedication with 2 μg kg -1  intranasal dexmedetomidine accompanied by cartoon video viewing can dramatically reduce emergence delirium in preschool children undergoing strabismus surgery, relieve preoperative anxiety and improve the parental satisfaction and the postoperative behavior changes during the first day after surgery.  Clinical Trial Registration:  ChiCTR2000030678.",2021,"However, during the first day after surgery, the PHBQ score was lower in Group DV compared with Group C ( P  = 0.001).  ","['One hundred and forty children aged 3-6 year undergoing elective strabismus surgery', 'Children Undergoing Strabismus Surgery', 'pediatric patients present with emergence delirium (ED', 'preschool children', 'preschool children undergoing strabismus surgery']","['dexmedetomidine', 'dexmedetomidine accompanied by the viewing of a cartoon video (Group DV) or without any premedication', 'Intranasal Dexmedetomidine Accompanied by Cartoon Video Preoperation', 'dexmedetomidine accompanied by cartoon video viewing']","['PHBQ score', 'parental satisfaction score', 'emergence delirium', 'severe emergence agitation', 'incidence of emergence delirium at the postanesthesia care unit (PACU), evaluated by the Pediatric Anesthesia Emergence Delirium (PAED) scale', 'PACU discharge time', 'incidence of emergence agitation (PAED score ≥ 10', 'Modified Yale Preoperative Anxiety Scale (mYPAS) upon separation from parents; the Induction Compliance Checklist score (ICC); the PACU discharge time; the parental satisfaction score; the incidences of the side effects and the Post-Hospital Behavior Questionnaire (PHBQ) score']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0007306', 'cui_str': 'Cartoons'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",140.0,0.0756191,"However, during the first day after surgery, the PHBQ score was lower in Group DV compared with Group C ( P  = 0.001).  ","[{'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Chu', 'Affiliation': 'Department of Anesthesiology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shaofei', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Central Laboratory, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhixing', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guyan', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}]",Frontiers in surgery,['10.3389/fsurg.2021.754591']
2385,34746212,Implementation of a Physical Activity Program Protocol in Schoolchildren: Effects on the Endocrine Adipose Tissue and Cognitive Functions.,"Practicing exercise is one of the best strategies to promote well-being and quality of life, however physical activity in schoolchildren and adolescents is developed in an unpredictable, intermittent way and in short periods. There are relatively few intervention studies investigating the role of physical activity in schoolchildren endocrine function of adipose tissue and cognitive function. One hundred and three boys, divided into two groups: control ( n  = 51, did not perform additional physical activity) and exercise ( n  = 52, performed vigorous physical activity after the regular school classes). The exercise group, developed a 6 months physical activity protocol delivered by the physical education teacher during the second semester of the academic course (6 months). Body composition measurements, adherence to the Mediterranean diet, nutritional intake, hematological and biochemical parameters, endocrine function of the adipose tissue and biomarkers of brain molecular function were assessed at enrolment and after 6 months of intervention. No statistically significant differences between both groups were found for age, height and bone mass. Weight and BMI was lower in the exercise group compared to the control group, increasing lean mass and reducing fat mass. 58.68% of children in the exercise group showed high adherence to the Mediterranean Diet compared to 46.32% of the control group. The exercise group was more concerned about their diet consumed more fiber, vitamin B1, B2, B6, B12, D, Niacin, Folic acid, Fe, Zn, Se and Cu. Triglycerides levels and HDL-cholesterol were higher in the exercise group at the end of the study. Leptin, MCP-1, lipocalin-2, adipsin and PAI-1 levels were lower in the exercise group at the end of the exercise protocol. In contrast, adiponectin and osteocrin markedly increased in the exercise group. Moreover, marked increases were recorded in healthy brain state biomarkers (NGF, BDNF, and irisin) in the exercise group, which could have a positive impact on academic performance. Taken together, all the findings reported are consistent with many benefits of the exercise protocol on adipose tissue and brain molecular function, demonstrating the usefulness of early interventions based on physical activity in children to reduce risk factors related to sedentary lifestyle.",2021,"Leptin, MCP-1, lipocalin-2, adipsin and PAI-1 levels were lower in the exercise group at the end of the exercise protocol.","['One hundred and three boys', 'Schoolchildren']","['exercise group was more concerned about their diet consumed more fiber, vitamin B1, B2, B6, B12, D, Niacin, Folic acid, Fe, Zn, Se and Cu', '6 months physical activity protocol delivered by the physical education teacher', 'control ( n  = 51, did not perform additional physical activity) and exercise ( n  = 52, performed vigorous physical activity', 'Physical Activity Program Protocol']","['high adherence to the Mediterranean Diet', 'Body composition measurements, adherence to the Mediterranean diet, nutritional intake, hematological and biochemical parameters, endocrine function of the adipose tissue and biomarkers of brain molecular function', 'adiponectin and osteocrin', 'Leptin, MCP-1, lipocalin-2, adipsin and PAI-1 levels', 'Triglycerides levels and HDL-cholesterol', 'lean mass and reducing fat mass', 'healthy brain state biomarkers (NGF, BDNF, and irisin', 'Weight and BMI']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0205172', 'cui_str': 'More'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0678896', 'cui_str': 'Endocrine function'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C0033457', 'cui_str': 'Complement factor D'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",103.0,0.00506203,"Leptin, MCP-1, lipocalin-2, adipsin and PAI-1 levels were lower in the exercise group at the end of the exercise protocol.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Diaz-Castro', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Campus Universitario de Cartuja, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose Eulogio', 'Initials': 'JE', 'LastName': 'Garcia-Vega', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Campus Universitario de Cartuja, University of Granada, Granada, Spain.'}, {'ForeName': 'Julio J', 'Initials': 'JJ', 'LastName': 'Ochoa', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Campus Universitario de Cartuja, University of Granada, Granada, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Puche-Juarez', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Campus Universitario de Cartuja, University of Granada, Granada, Spain.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Toledano', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Campus Universitario de Cartuja, University of Granada, Granada, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moreno-Fernandez', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Campus Universitario de Cartuja, University of Granada, Granada, Spain.'}]",Frontiers in nutrition,['10.3389/fnut.2021.761213']
2386,34746209,Effect of  Saengshik  Supplementation on the Gut Microbial Composition of Healthy Korean Adults: A Single-Group Pilot Study.,"Saengshik  is a type of meal-replacement product or dietary supplement comprising an uncooked and dried plant-based food mixture with various health-promoting properties, such as antidiabetic, anti-dyslipidemic, antioxidant, and anticancer properties. Although these properties are considered attributable to the various bioactive components absorbed through the intestine and its remolding effect on intestinal microorganisms, the effect of  Saengshik  supplementation on gut microbiota profiles has not yet been studied. In this study, we investigated the effect of  Saengshik  administration on the composition of gut microbiota. This single-group design trial was conducted on 102 healthy men and women who received 40 g/day of  Saengshik  powder for 8 weeks, during which stool samples were collected at two fixed time points (baseline and the endpoint) for gut microbiota-profiling analysis. We observed a significant decrease in the α-diversity of gut microbiota after  Saengshik  consumption ( P  < 0.05), with significant changes identified in the composition of major microbial taxa, such as  Bacteroidetes  ( P  < 0.0001),  Proteobacteria, Actinobacteria , and  Verrucomicrobia  ( P  < 0.0001). Notably, the gut microbial response was related to the inter-individual variability of habitual dietary intake and enterotype at baseline. To the best of our knowledge, this is the first study investigating the effects of  Saengshik  intake on changes in gut microbiota, with the results suggesting that individual habitual diet patterns and gut microbial shapes should be considered key aspects in  Saengshik -mediated health-promotion effects.",2021,"We observed a significant decrease in the α-diversity of gut microbiota after  Saengshik  consumption ( P  < 0.05), with significant changes identified in the composition of major microbial taxa, such as  Bacteroidetes  ( P  < 0.0001),  Proteobacteria, Actinobacteria , and  Verrucomicrobia  ( P  < 0.0001).","['Healthy Korean Adults', '102 healthy men and women who received 40 g/day of  Saengshik  powder for 8 weeks, during which stool samples']",['Saengshik  Supplementation'],"['gut microbial response', 'composition of gut microbiota', 'Gut Microbial Composition', 'α-diversity of gut microbiota after  Saengshik  consumption', 'composition of major microbial taxa, such as  Bacteroidetes', 'Proteobacteria, Actinobacteria , and  Verrucomicrobia']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C0600148', 'cui_str': 'Class Actinobacteria'}, {'cui': 'C1094021', 'cui_str': 'Verrucomicrobia'}]",102.0,0.0335658,"We observed a significant decrease in the α-diversity of gut microbiota after  Saengshik  consumption ( P  < 0.05), with significant changes identified in the composition of major microbial taxa, such as  Bacteroidetes  ( P  < 0.0001),  Proteobacteria, Actinobacteria , and  Verrucomicrobia  ( P  < 0.0001).","[{'ForeName': 'Ji-Hee', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju-gun, South Korea.'}, {'ForeName': 'Yong Ju', 'Initials': 'YJ', 'LastName': 'Ahn', 'Affiliation': 'Theragen Bio Co., Ltd., Seongnam-si, South Korea.'}, {'ForeName': 'Won-Hyong', 'Initials': 'WH', 'LastName': 'Chung', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju-gun, South Korea.'}, {'ForeName': 'Mi Young', 'Initials': 'MY', 'LastName': 'Lim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju-gun, South Korea.'}, {'ForeName': 'Seungpyo', 'Initials': 'S', 'LastName': 'Hong', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju-gun, South Korea.'}, {'ForeName': 'Joong-Hark', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Erom R&D Center, Erom Co., Ltd., Chuncheon-si, South Korea.'}, {'ForeName': 'Mi Houn', 'Initials': 'MH', 'LastName': 'Park', 'Affiliation': 'Erom R&D Center, Erom Co., Ltd., Chuncheon-si, South Korea.'}, {'ForeName': 'Young-Do', 'Initials': 'YD', 'LastName': 'Nam', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju-gun, South Korea.'}]",Frontiers in nutrition,['10.3389/fnut.2021.743620']
2387,34746173,Process Evaluation of an Online SUpport PRogram for Older Hearing Aid Users Delivered in a Cluster Randomized Controlled Trial.,"Objectives:  To evaluate the process of implementing a web-based support program (SUPR) for hearing aid users in the Dutch dispensing setting in order to allow interpretation of the randomized controlled trial's results (positive effects on hearing-aid related outcomes; no effects on psychosocial outcomes).  Design:  Measures: context of implementation, recruitment, SUPR's: reach, implementation fidelity, dose delivered, dose received, satisfaction, and benefit. Data collection: quantitative and qualitative.  Study Sample:  One hundred thirty-eight clients (mean age 68.1 years; 60% male) and 44 dispensers completed questionnaires. Five clients and 6 dispensers participated in interviews and focus groups.  Results:  Clients and dispensers were generally satisfied with SUPR's usefulness. SUPR-videos were watched by 7-37% of the clients. Around half of the dispensers encouraged clients to watch them or informed them about SUPR. Some clients found the SUPR-materials suboptimal, and changes in personnel and limited dispenser-training were barriers acting on a contextual level.  Conclusions:  This study identified several factors that contributed to the success of SUPR. Others factors, acting on various levels (e.g., intervention material, dispensers, and implementation context), were suboptimal and may explain the absent psychosocial effects. The identified factors are important to consider in further development of SUPR, and in other web-based support programs.",2021,Objectives:  To evaluate the process of implementing a web-based support program (SUPR) for hearing aid users in the Dutch dispensing setting in order to allow interpretation of the randomized controlled trial's results (positive effects on hearing-aid related outcomes; no effects on psychosocial outcomes).  ,"['Older Hearing Aid', '44 dispensers completed questionnaires', 'Study Sample:  One hundred thirty-eight clients (mean age 68.1 years; 60% male) and', 'Five clients and 6 dispensers participated in interviews and focus groups', 'hearing aid users in the Dutch dispensing setting']","['implementing a web-based support program (SUPR', 'Online SUpport PRogram']",['SUPR-videos'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0180463', 'cui_str': 'Dispenser'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0919808', 'cui_str': 'Hearing aid user'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}]",5.0,0.0380363,Objectives:  To evaluate the process of implementing a web-based support program (SUPR) for hearing aid users in the Dutch dispensing setting in order to allow interpretation of the randomized controlled trial's results (positive effects on hearing-aid related outcomes; no effects on psychosocial outcomes).  ,"[{'ForeName': 'Janine F J', 'Initials': 'JFJ', 'LastName': 'Meijerink', 'Affiliation': 'Otolaryngology - Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, Amsterdam University Medical Center (UMC), Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Pronk', 'Affiliation': 'Otolaryngology - Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, Amsterdam University Medical Center (UMC), Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Birgit I', 'Initials': 'BI', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Epidemiology and Data Science, Amsterdam University Medical Center (UMC), Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Jansen', 'Affiliation': 'Schoonenberg HoorSupport, Rotterdam, Netherlands.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'Kramer', 'Affiliation': 'Otolaryngology - Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, Amsterdam University Medical Center (UMC), Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",Frontiers in medicine,['10.3389/fmed.2021.725388']
2388,34746161,Exclusive Enteral Nutrition Plus Immediate vs. Delayed Washed Microbiota Transplantation in Crohn's Disease With Malnutrition: A Randomized Pilot Study.,"Background:  The potential of washed microbiota transplantation (WMT) in Crohn's disease (CD) has been reported. This study aimed to explore the suitable timing of WMT in patients with CD complicated with malnutrition.  Methods:  This is a randomized, open-label study. Patients with active CD complicated with malnutrition were included and 1:1 randomized to undergo WMT at day 1 (group WMT-DAY1) or day 8 (group WMT-DAY8). The observation duration was 15 days. Exclusive enteral nutrition (EEN) was administered in both groups. The primary outcome was the improvement in nutritional parameters at day 8 and day 15 in two groups. The secondary outcome was the rate of clinical remission at day 15 in two groups.  Results:  Totally 19 patients completed the trial. At day 8, the lymphocyte count, albumin and prealbumin increased significantly compared to those at day 1 in group WMT-DAY1 ( p  = 0.018,  p  = 0.028,  p  = 0.028, respectively), while no significant increase in any nutritional parameter was shown in group WMT-DAY8. At day 15, albumin increased significantly compared to that at day 1 in both groups ( p  < 0.05), while significant increase in prealbumin was only shown in group WMT-DAY1 ( p  = 0.004) compared to that at day 1. The rate of clinical remission at day 15 in group WMT-DAY1 and group WMT-DAY8 was 87.5% (7/8) and 72.7% (8/11), respectively ( p  = 0.603).  Conclusion:  EEN combined with immediate WMT intervention could rapidly improve the nutritional status and induce clinical remission in malnourished patients with CD.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT02897661.",2021,"At day 15, albumin increased significantly compared to that at day 1 in both groups ( p  < 0.05), while significant increase in prealbumin was only shown in group WMT-DAY1 ( p  = 0.004) compared to that at day 1.","[""Crohn's Disease"", 'Totally 19 patients completed the trial', ""Crohn's disease (CD"", 'malnourished patients with CD', 'Patients with active CD complicated with malnutrition', 'patients with CD complicated with malnutrition']","['WMT', 'Exclusive enteral nutrition (EEN', 'Exclusive Enteral Nutrition Plus Immediate vs. Delayed Washed Microbiota Transplantation', 'washed microbiota transplantation (WMT', 'EEN combined with immediate WMT intervention']","['nutritional parameter', 'improvement in nutritional parameters', 'prealbumin', 'rate of clinical remission', 'lymphocyte count, albumin and prealbumin', 'nutritional status and induce clinical remission']","[{'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1547959', 'cui_str': 'Wash'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",19.0,0.112318,"At day 15, albumin increased significantly compared to that at day 1 in both groups ( p  < 0.05), while significant increase in prealbumin was only shown in group WMT-DAY1 ( p  = 0.004) compared to that at day 1.","[{'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Xiang', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Division of Clinical Nutrition, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wen', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Bota', 'Initials': 'B', 'LastName': 'Cui', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Faming', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}]",Frontiers in medicine,['10.3389/fmed.2021.666062']
2389,34746480,Impact of a soft tip nicotine-free harmless cigarette as part of a smoking cessation program with psychological support and varenicline: an integrated workplace smoking cessation intervention.,"Cigarette consumption in the general population has shown a sustained decline over the past 20 years, but despite this, it is essential to monitor consumption among smokers at their workplace. There is an association between cigarette addiction and work-related stressors, with high prevalence rates for smokers, at least double those of other adults. This two-group randomized clinical trial compared the 12-week combined effect of psychological support and varenicline associated with the use or not of a nicotine-free inhaler with a soft mouthpiece (QuitGo™) on the 4 to 24-week cessation rate in enrolled smokers to a smoking cessation program promoted by our research group. The results of the logistic model analysis showed that the likelihood of quitting successfully at week 24 was significantly higher in the QuitGO™ group than in the control group for participants with high behavioral dependence as assessed by Glover-Nilsson Smoking Behavioral Questionnaire-GN-SBQ (OR = 8.55; CI at 95% = 1.75-43.20). The data presented suggest that the soft tip nicotine-free harmless cigarette may be helpful for smokers and those with work-related stress symptoms who recognize the need to have a gesture in the traditional cigarette smoking ritual.",2021,The results of the logistic model analysis showed that the likelihood of quitting successfully at week 24 was significantly higher in the QuitGO™ group than in the control group for participants with high behavioral dependence as assessed by Glover-Nilsson Smoking Behavioral Questionnaire-GN-SBQ (OR = 8.55; CI at 95% = 1.75-43.20).,['enrolled smokers to a smoking cessation program promoted by our research group'],"['nicotine-free inhaler with a soft mouthpiece (QuitGo™', 'soft tip nicotine-free harmless cigarette', 'psychological support and varenicline', 'varenicline']","['likelihood of quitting successfully', 'Glover-Nilsson Smoking Behavioral Questionnaire-GN-SBQ']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0406931,The results of the logistic model analysis showed that the likelihood of quitting successfully at week 24 was significantly higher in the QuitGO™ group than in the control group for participants with high behavioral dependence as assessed by Glover-Nilsson Smoking Behavioral Questionnaire-GN-SBQ (OR = 8.55; CI at 95% = 1.75-43.20).,"[{'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Maglia', 'Affiliation': 'University of Catania, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Caponnetto', 'Affiliation': 'University of Catania, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Polosa', 'Affiliation': 'University of Catania, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Russo', 'Affiliation': 'University of Catania, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Santisi', 'Affiliation': 'University of Catania, Italy.'}]",Health psychology research,['10.52965/001c.24506']
2390,34746427,SaeboGlove therapy for upper limb disability and severe hand impairment after stroke (SUSHI): Study protocol for a randomised controlled trial.,"Background


Impaired active digital extension is common after stroke, hindering functional rehabilitation, and predicting poor recovery. The SaeboGlove assists digital extension and may improve outcome after stroke. We recently performed a single group, open, pilot trial of the SaeboGlove early after stroke which demonstrated satisfactory safety, feasibility and acceptability. An adequately powered randomised clinical trial is now needed to assess the clinical effectiveness of the SaeboGlove.
Methods


SUSHI is a pragmatic, multicentre, parallel-group, randomised controlled trial with blinded outcome assessment, and embedded process and economic evaluations. Adults, 7-60 days post-stroke, with upper limb disability and severe hand impairment, including reduced active digital extension, will be recruited from NHS inpatient stroke services in Scotland. Participants will be randomised on a 1:1 basis to receive 6 weeks of self-directed, repetitive, functional-based practice involving a SaeboGlove plus usual care, or usual care only. The primary outcome is upper limb function measured by the Action Research Arm Test (ARAT) at 6 weeks. Secondary outcomes will be measured at 6 and 14 weeks. A process evaluation will be performed via interviews with 'intervention' participants, and their carers and clinical therapists. A within-trial cost-effectiveness analysis will be performed. 110 participants are required to detect a difference between groups of 9 in the ARAT with 90% power at a 5% significance level allowing for 11% attrition.
Discussion


SUSHI will determine if SaeboGlove self-directed, repetitive, functional-based practice improves upper limb function after stroke, whether it is acceptable to stroke survivors and whether it is cost-effective.",2021,"Adults, 7-60 days post-stroke, with upper limb disability and severe hand impairment, including reduced active digital extension, will be recruited from NHS inpatient stroke services in Scotland.","['110 participants', 'Adults, 7-60\u2009days post-stroke, with upper limb disability and severe hand impairment, including reduced active digital extension, will be recruited from NHS inpatient stroke services in Scotland', 'upper limb disability and severe hand impairment after stroke (SUSHI']","['SaeboGlove therapy', 'self-directed, repetitive, functional-based practice involving a SaeboGlove plus usual care, or usual care only']","['satisfactory safety, feasibility and acceptability', 'upper limb function measured by the Action Research Arm Test (ARAT']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0587667', 'cui_str': 'Stroke service'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}]",110.0,0.169356,"Adults, 7-60 days post-stroke, with upper limb disability and severe hand impairment, including reduced active digital extension, will be recruited from NHS inpatient stroke services in Scotland.","[{'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Alexander', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langhorne', 'Affiliation': 'Academic Section of Geriatric Medicine, Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary & Life Sciences, University of Glasgow, Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kidd', 'Affiliation': 'School of Medicine, Dentistry & Nursing, College of Medical, Veterinary & Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wu', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Frederike', 'Initials': 'F', 'LastName': 'van Wijck', 'Affiliation': 'Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary & Life Sciences, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.'}]",European stroke journal,['10.1177/23969873211036586']
2391,34746426,A computer-game-based rehabilitation platform for individuals with fine and gross motor upper extremity deficits post-stroke (CARE fOR U) - Protocol for a randomized controlled trial.,"Background & purpose


Activity-based neuroplasticity and re-organization leads to motor learning via replicating real-life movements. Increased repetition of such movements has growing evidence over last few decades. In particular, computer-game-based rehabilitation is found to be effective, feasible and acceptable for post-stroke upper limb deficits. Our study aims to evaluate the feasibility and effectiveness of 12 weeks of computer-game-based rehabilitation platform (GRP) on fine and gross motor skills post-stroke in India.
Methods


Through this trial we will study the effect of adjunctive in-hospital GRP (using a motion-sensing airmouse with off-the-shelf computer games) in 80 persons with subacute stroke, for reduction of post-stroke upper limb deficits in a single-centre prospective Randomized Open, Blinded End- point trial when compared to conventional therapy alone.
Results


We intend to evaluate between-group differences using Wolf Motor Function test, Stroke Specific Quality of Life, and GRP assessment tool. Feasibility will be assessed via recruitment rates, adherence to intervention periods, drop-out rate and qualitative findings of patient experience with the intervention.
Conclusion


The CARE FOR U trial is designed to test the feasibility and effectiveness of a computer-game based rehabilitation platform in treating upper limb deficits after stroke. In case of positive findings GRP can be widely applicable for stroke populations needing intensive and regular therapy with supervision.",2021,"In particular, computer-game-based rehabilitation is found to be effective, feasible and acceptable for post-stroke upper limb deficits.","['individuals with fine and gross motor upper extremity deficits post-stroke (CARE fOR U', '80 persons with subacute stroke, for reduction of post-stroke upper limb deficits in a single-centre']","['computer-game-based rehabilitation platform', 'conventional therapy alone', 'computer-game-based rehabilitation platform (GRP', 'computer-game based rehabilitation platform', 'adjunctive in-hospital GRP (using a motion-sensing airmouse with off-the-shelf computer games']","['Wolf Motor Function test, Stroke Specific Quality of Life, and GRP assessment tool', 'feasibility and effectiveness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]","[{'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",80.0,0.0256978,"In particular, computer-game-based rehabilitation is found to be effective, feasible and acceptable for post-stroke upper limb deficits.","[{'ForeName': 'Dorcas Bc', 'Initials': 'DB', 'LastName': 'Gandhi', 'Affiliation': 'Department of Neurology, College of Physiotherapy, Christian Medical College and Hospital, Ludhiana, India.'}, {'ForeName': 'Jeyaraj D', 'Initials': 'JD', 'LastName': 'Pandian', 'Affiliation': 'Christian Medical College and Hospital, Ludhiana, India.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Szturm', 'Affiliation': 'College of Rehabilitation Sciences, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Anuprita', 'Initials': 'A', 'LastName': 'Kanitkar', 'Affiliation': 'Applied Health Sciences, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Mahesh P', 'Initials': 'MP', 'LastName': 'Kate', 'Affiliation': 'Department of Clinical Neurosciences, University of Alberta Hospital, Edmonton, Canada.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Bhanot', 'Affiliation': 'Department of Neurology, Christian Medical College and Hospital, Ludhiana, India.'}]",European stroke journal,['10.1177/2396987321994293']
2392,34746425,"Design of a randomised, double-blind, crossover, placebo-controlled trial of effects of sildenafil on cerebrovascular function in small vessel disease: Oxford haemodynamic adaptation to reduce pulsatility trial (OxHARP).","Background


Cerebral small vessel disease (SVD) is associated with increased cerebrovascular pulsatility, endothelial dysfunction, and impaired vascular reactivity. Vasodilating phosphodiesterase inhibitors may improve cardiovascular pulsatility and reactivity, and potentially reduce progression of SVD.Hypothesis: Sildenafil, a PDE5 inhibitor, will reduce cerebrovascular pulsatility and increase cerebrovascular reactivity compared to placebo, and is non-inferior to cilostazol, a PDE3 inhibitor.
Methods


OxHARP is a randomised, double-blind, crossover trial of sildenafil 50 mg thrice daily, cilostazol 100 mg twice daily and placebo in 75 patients with mild to moderate small vessel disease and a previous lacunar or cryptogenic stroke or TIA. Participants undergo a physiological assessment at baseline and on each treatment, including transcranial Doppler ultrasound (TCD, DWL DopplerBox) to assess cerebrovascular pulsatility and reactivity to 4-6% carbon dioxide. In up to 60 patients, cerebrovascular pulsatility, perfusion and reactivity will also be assessed by MRI.
Outcome measures


The primary outcome is difference in middle cerebral artery pulsatility (Gosling's Pulsatility Index, PI) after 3 weeks of sildenafil versus placebo. Secondary outcomes including non-inferiority of sildenafil vs cilostazol in effects on PI, percentage increase in MCA blood flow velocity and BOLD-fMRI response during inhalation of 4-6% carbon dioxide.
Discussion


Reduction in cerebral pulsatility and increased cerebrovascular reactivity during treatment with sildenafil would indicate potential benefit to prevent progression of SVD, suggesting a need for trials with clinical outcomes.Trial Registration OxHARP is registered with ClinicalTrials.org, NCT03855332.",2021,"Secondary outcomes including non-inferiority of sildenafil vs cilostazol in effects on PI, percentage increase in MCA blood flow velocity and BOLD-fMRI response during inhalation of 4-6% carbon dioxide.
","['75 patients with mild to moderate small vessel disease and a previous lacunar or cryptogenic stroke or TIA', 'small vessel disease']","['cilostazol 100\u2009mg twice daily and placebo', 'Vasodilating phosphodiesterase inhibitors', 'sildenafil', 'placebo', 'transcranial Doppler ultrasound (TCD, DWL DopplerBox']","['cerebrovascular pulsatility, perfusion and reactivity', 'cerebrovascular function', 'cerebrovascular reactivity', 'cerebral pulsatility and increased cerebrovascular reactivity', 'cerebrovascular pulsatility, endothelial dysfunction, and impaired vascular reactivity', 'cardiovascular pulsatility and reactivity', ""middle cerebral artery pulsatility (Gosling's Pulsatility Index, PI"", 'non-inferiority of sildenafil vs cilostazol in effects on PI, percentage increase in MCA blood flow velocity and BOLD-fMRI response during inhalation of 4-6% carbon dioxide', 'cerebrovascular pulsatility and reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}]","[{'cui': 'C0984910', 'cui_str': 'cilostazol 100 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031638', 'cui_str': 'Phosphodiesterase inhibitor'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0007928', 'cui_str': 'Chad'}]","[{'cui': 'C0577317', 'cui_str': 'Pulsatility'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0000325', 'cui_str': '20-Methylcholanthrene'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]",75.0,0.898946,"Secondary outcomes including non-inferiority of sildenafil vs cilostazol in effects on PI, percentage increase in MCA blood flow velocity and BOLD-fMRI response during inhalation of 4-6% carbon dioxide.
","[{'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Wolfson Centre for Prevention of Stroke and Dementia, University of Oxford, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Werring', 'Affiliation': 'Stroke Research Centre, UCL Institute of Neurology, London, UK.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary & Life Sciences, Queen Elizabeth University Hospital, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rothman', 'Affiliation': 'Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lawson', 'Affiliation': 'Wolfson Centre for Prevention of Stroke and Dementia, University of Oxford, Oxford, UK.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Wartolowska', 'Affiliation': 'Wolfson Centre for Prevention of Stroke and Dementia, University of Oxford, Oxford, UK.'}]",European stroke journal,['10.1177/23969873211026698']
2393,34746424,Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) - An explorative randomized controlled trial.,"Background


Optimal blood pressure is not well established during endovascular therapy of acute ischemic stroke. Applying standardized blood pressure target values for every stroke patient might be a suboptimal approach.
Aim


To assess whether an individualized intraprocedural blood pressure management with individualized blood pressure target ranges might pose a better strategy for the outcome of the patients than standardized blood pressure targets. Sample size:  Randomization of 250 patients 1:1 to receive either standard or individualized blood pressure management approach.
Methods and design


We conduct an explorative single-center randomized controlled trial with a PROBE (parallel-group, open-label randomized controlled trial with blinded endpoint evaluation) design. In the control group, intraprocedural systolic blood pressure target range is 140-180 mmHg. The intervention group is the individualized approach, which is maintaining the intraprocedural systolic blood pressure at the level on presentation (±10 mmHg). Study outcomes:  The primary endpoint is the modified Rankin scale assessed 90 days +/- 2 weeks after stroke onset, dichotomized by 0-2 (favorable outcome) to 3-6 (unfavorable outcome). Secondary endpoints include early neurological improvement, infarction size, and systemic physiology monitor parameters.
Discussion


An individualized approach for blood pressure management during thrombectomy could lead to a better outcome for stroke patients. The trial is registered at clinicaltrials.gov as 'Individualized Blood Pressure Management During Endovascular Stroke Treatment (INDIVIDUATE)' under NCT04578288.",2021,The primary endpoint is the modified Rankin scale assessed 90 days +/-,"['stroke patients', '250 patients 1:1 to receive either', 'patients than standardized blood pressure targets']","['standard or individualized blood pressure management approach', 'individualized intraprocedural blood pressure management with individualized blood pressure target ranges', 'Individualized blood pressure management', 'procedural sedation (INDIVIDUATE) ']","['early neurological improvement, infarction size, and systemic physiology monitor parameters', 'intraprocedural systolic blood pressure target range', 'modified Rankin scale assessed 90 days ']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",250.0,0.258369,The primary endpoint is the modified Rankin scale assessed 90 days +/-,"[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Kronsteiner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Möhlenbruch', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Meinhard', 'Initials': 'M', 'LastName': 'Kieser', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nagel', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ringleb', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Schönenberger', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany.'}]",European stroke journal,['10.1177/23969873211000879']
2394,34746417,"Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020.","Background


The novel SARS-CoV-2 has caused the coronavirus disease 2019 (COVID-19) pandemic. Currently, with insufficient worldwide vaccination rates, identifying treatment solutions to reduce the impact of the virus is urgently needed.
Method


An adaptive, multicentric, open-label, and randomized controlled phase I/II clinical trial entitled the ""SENTAD-COVID Study"" was conducted by the  Abu Dhabi Stem Cells Center  under exceptional conditional approval by the Emirates Institutional Review Board (IRB) for COVID-19 Research Committee from April 4th to July 31st, 2020, using an autologous peripheral blood non-hematopoietic enriched stem cell cocktail (PB-NHESC-C) administered by compressor (jet) nebulization as a complement to standard care therapy. The primary endpoints include safety and efficacy assessments, adverse events, the mortality rate within 28 days, and the time to clinical improvement as measured by a 2-point reduction on a seven-category ordinal scale or discharge from the hospital whichever occurred first.
Results


The study included a total of 139 randomized COVID-19 patients, with 69 in the experimental group and 70 in the control group (standard care). Overall survival was 94.20% for the cocktail-treated group vs. 90.27% for the control group. Adverse events were reported in 50 (72.46%) patients receiving PB-NHESC-C and 51 (72.85%) in the control group ( p  = 0.9590), with signs and symptoms commonly found in COVID-19. After the first 9 days of the intervention, 67.3% of cocktail-treated patients recovered and were released from hospitals compared to 53.1% (RR = 0.84; 95% CI, 0.56-1.28) in the control group. Improvement, i.e., at least a 2-point reduction in the severity scale, was more frequently observed in cocktail-treated patients (42.0%) than in controls (17.0%) (RR = 0.69; 95% CI, 0.56-0.88).
Conclusions


Cocktail treatment improved clinical outcomes without increasing adverse events. Thus, the nebulization of PB-NHESC-C was safe and effective for treatment in most of these patients.
Trial registration


ClinicalTrials.gov. NCT04473170. It was retrospectively registered on July 16th, 2020.",2021,Overall survival was 94.20% for the cocktail-treated group vs. 90.27% for the control group.,"['139 randomized COVID-19 patients, with 69 in the experimental group and 70 in the control group (standard care', 'COVID-19 patients']","['autologous non-hematopoietic enriched stem cell nebulization', 'autologous peripheral blood non-hematopoietic enriched stem cell cocktail (PB-NHESC-C) administered by compressor (jet) nebulization']","['Overall survival', 'Adverse events', 'safety and efficacy assessments, adverse events, the mortality rate within 28\u2009days, and the time to clinical improvement as measured by a 2-point reduction on a seven-category ordinal scale or discharge from the hospital whichever occurred first', 'severity scale', 'Safety and efficacy']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",139.0,0.210285,Overall survival was 94.20% for the cocktail-treated group vs. 90.27% for the control group.,"[{'ForeName': 'Yendry', 'Initials': 'Y', 'LastName': 'Ventura-Carmenate', 'Affiliation': 'Abu Dhabi Stem Cells Center, Al Misahah Street, Villa No. 25, Rowdhat, Zone-1, POB 4600, Abu Dhabi City, United Arab Emirates.'}, {'ForeName': 'Fatima Mohammed', 'Initials': 'FM', 'LastName': 'Alkaabi', 'Affiliation': 'Sheikh Khalifa Medical City Hospital, POB 51900, Abu Dhabi City, United Arab Emirates.'}, {'ForeName': 'Yandy Marx', 'Initials': 'YM', 'LastName': 'Castillo-Aleman', 'Affiliation': 'Abu Dhabi Stem Cells Center, Al Misahah Street, Villa No. 25, Rowdhat, Zone-1, POB 4600, Abu Dhabi City, United Arab Emirates.'}, {'ForeName': 'Carlos Agustin', 'Initials': 'CA', 'LastName': 'Villegas-Valverde', 'Affiliation': 'Abu Dhabi Stem Cells Center, Al Misahah Street, Villa No. 25, Rowdhat, Zone-1, POB 4600, Abu Dhabi City, United Arab Emirates.'}, {'ForeName': 'Yasmine Maher', 'Initials': 'YM', 'LastName': 'Ahmed', 'Affiliation': 'Abu Dhabi Stem Cells Center, Al Misahah Street, Villa No. 25, Rowdhat, Zone-1, POB 4600, Abu Dhabi City, United Arab Emirates.'}, {'ForeName': 'Pierdanilo', 'Initials': 'P', 'LastName': 'Sanna', 'Affiliation': 'Abu Dhabi Stem Cells Center, Al Misahah Street, Villa No. 25, Rowdhat, Zone-1, POB 4600, Abu Dhabi City, United Arab Emirates.'}, {'ForeName': 'Ayesha Abdulla', 'Initials': 'AA', 'LastName': 'Almarzooqi', 'Affiliation': 'Sheikh Khalifa Medical City Hospital, POB 51900, Abu Dhabi City, United Arab Emirates.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Abdelrazik', 'Affiliation': 'Abu Dhabi Stem Cells Center, Al Misahah Street, Villa No. 25, Rowdhat, Zone-1, POB 4600, Abu Dhabi City, United Arab Emirates.'}, {'ForeName': 'Gina Marcela', 'Initials': 'GM', 'LastName': 'Torres-Zambrano', 'Affiliation': 'Abu Dhabi Stem Cells Center, Al Misahah Street, Villa No. 25, Rowdhat, Zone-1, POB 4600, Abu Dhabi City, United Arab Emirates.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Wade-Mateo', 'Affiliation': 'McHari International College, Nassau, Bahamas.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Quesada-Saliba', 'Affiliation': 'Miami Dade College, Mathematics Department Chair, Wolfson Campus, Miami, FL 33132 USA.'}, {'ForeName': 'Loubna', 'Initials': 'L', 'LastName': 'Abdel Hadi', 'Affiliation': 'Abu Dhabi Stem Cells Center, Al Misahah Street, Villa No. 25, Rowdhat, Zone-1, POB 4600, Abu Dhabi City, United Arab Emirates.'}, {'ForeName': 'Antonio Alfonso', 'Initials': 'AA', 'LastName': 'Bencomo-Hernandez', 'Affiliation': 'Abu Dhabi Stem Cells Center, Al Misahah Street, Villa No. 25, Rowdhat, Zone-1, POB 4600, Abu Dhabi City, United Arab Emirates.'}, {'ForeName': 'Rene Antonio', 'Initials': 'RA', 'LastName': 'Rivero-Jimenez', 'Affiliation': 'Abu Dhabi Stem Cells Center, Al Misahah Street, Villa No. 25, Rowdhat, Zone-1, POB 4600, Abu Dhabi City, United Arab Emirates.'}]",Translational medicine communications,['10.1186/s41231-021-00101-5']
2395,34746838,Comparison of physiological and clinical markers for chronic sprint-interval training exercise performed either in the fasted or fed states among healthy adults.,"Sprint-interval training (SIT) and intermittent fasting are effective independent methods in achieving clinical health outcomes. However, the impact of both modalities when performed concurrently is unclear. The aim of this study was to compare the effects of 6 weeks of SIT performed in the fasted versus fed state on physiological and clinical health markers in healthy adults.  Methods.  Thirty recreationally-active participants were equally randomised into either the fasted (FAS; 4 males, 11 females) or the fed (FED; 6 males, 9 females) group. For all exercise sessions, FAS participants had to fast ≥10 h prior to exercising while FED participants had to consume food within 3 h to exercise. All participants underwent three sessions of SIT per week for 6 weeks. Each session consists of repeated bouts of 30-s Wingate Anaerobic cycle exercise. Pre- and post-training peak oxygen uptake (VO 2peak ), isokinetic leg strength, insulin sensitivity, blood pressure and serum lipid levels were assessed.  Results.  There were no differences in baseline physiological and clinical measures between both groups (all  p  > 0.05). VO 2peak  improved by 6.0 ± 8.8% in the FAS group and 5.3 ± 10.6% in the FED group (both  p  < 0.05), however the difference in improvement between groups was not statistically significant ( p  > 0.05). A similar pattern of results was seen for knee flexion maximum voluntary contraction at 300°·s -1 . SIT training in either fasted or fed state had no impact on insulin sensitivity (both  p  > 0.05). There was significant reduction in diastolic blood pressure (8.2 ± 4.2%) and mean arterial pressure (7.0 ± 3.2%) in the FAS group (both  p  < 0.05) but not FED group (both  p  > 0.05).  Conclusion.  VO 2peak  and leg strength improved with SIT regardless of whether participants trained in the fasted or fed state. Chronic SIT in the fasted state may potentially reduce blood pressure to a greater extent than the same chronic SIT in the fed state.",2021,SIT training in either fasted or fed state had no impact on insulin sensitivity (both  p  > 0.05).,"['healthy adults', 'Thirty recreationally-active participants were equally randomised into either the fasted (FAS; 4 males, 11 females) or the fed (FED; 6 males, 9 females) group']","['SIT training', 'chronic sprint-interval training exercise', 'Sprint-interval training (SIT) and intermittent fasting']","['insulin sensitivity', 'mean arterial pressure', 'baseline physiological and clinical measures', 'VO 2peak', 'diastolic blood pressure', 'VO 2peak  and leg strength', 'knee flexion maximum voluntary contraction', 'Pre- and post-training peak oxygen uptake (VO 2peak ), isokinetic leg strength, insulin sensitivity, blood pressure and serum lipid levels', 'blood pressure']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",,0.0466803,SIT training in either fasted or fed state had no impact on insulin sensitivity (both  p  > 0.05).,"[{'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tan', 'Affiliation': 'Singapore Sport Medicine Centre, Changi General Hospital, Singapore.'}, {'ForeName': 'Ivy', 'Initials': 'I', 'LastName': 'Lim', 'Affiliation': 'Singapore Sport Medicine Centre, Changi General Hospital, Singapore.'}, {'ForeName': 'Pei Ting', 'Initials': 'PT', 'LastName': 'Tan', 'Affiliation': 'Clinical Trials and Research Unit, Changi General Hospital, Singapore.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Tan', 'Affiliation': 'Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Abdul Rashid', 'Initials': 'AR', 'LastName': 'Aziz', 'Affiliation': 'Sport Science & Sport Medicine, Singapore Sport Institute, Sport Singapore, Singapore.'}]",Current research in physiology,['10.1016/j.crphys.2021.09.003']
2396,34746837,Nitric oxide enhancement supplement containing beet nitrite and nitrate benefits high intensity cycle interval training.,"This study investigated the effects of a beet nitric oxide enhancing (NOE) supplement comprised of nitrite and nitrate on cycling performance indices in trained cyclists.
METHODS


Subjects completed a lactate threshold test and a high-intensity interval (HIIT) protocol at 50% above functional threshold power with or without oral NOE supplement.
RESULTS


NOE supplementation enhanced lactate threshold by 7.2% (Placebo = 191.6 ± 37.3 W, NOE = 205.3 ± 39.9; p = 0.01; Effect Size (ES) = 0.40). During the HIIT protocol, NOE supplementation improved time to exhaustion 18% (Placebo = 1251 ± 562s, NOE = 1474 ± 504s; p = 0.02; ES = 0.42) and total energy expended 22.3% (Placebo = 251 ± 48.6 kJ, NOE = 306.6 ± 55.2 kJ; p = 0.01; ES = 1.079). NOE supplementation increased the intervals completed (Placebo = 7.00 ± 2.5, NOE = 8.14 ± 2.4; p = 0.03; ES = 0.42) and distance cycled (Placebo = 10.9 ± 4.0 km, NOE = 13.5 ± 3.9 km; p = 0.01; ES = 0.65). Also, target power was achieved at a higher cadence during the HIIT work and rest periods (p = 0.02), which enhanced muscle oxygen saturation (SmO 2 ) recovery. Time-to-fatigue was negatively correlated with the degree of SmO 2 , desaturation during the HIIT work interval segment (r = -0.67; p 0.008), while both SmO 2  desaturation and the SmO 2  starting work segment saturation level correlated with a cyclist's kJ expended (SmO 2  desaturation: r = -0.51, p = 0.06; SmO 2  starting saturation: r = 0.59, p = 0.03).
CONCLUSION


NOE supplementation containing beet nitrite and nitrate enhanced submaximal (lactate threshold) and HIIT maximal effort work. The NOE supplementation resulted in a cyclist riding at higher cadence rates with lower absolute torque values at the same power during both the work and rest periods, which in-turn delayed over-all fatigue and improved total work output.",2021,"The NOE supplementation resulted in a cyclist riding at higher cadence rates with lower absolute torque values at the same power during both the work and rest periods, which in-turn delayed over-all fatigue and improved total work output.","['Subjects completed a lactate threshold test and a high-intensity interval (HIIT) protocol at 50% above functional threshold power with or without oral NOE supplement', '1474\xa0±\xa0504s', 'trained cyclists']",['beet nitric oxide enhancing (NOE) supplement comprised of nitrite and nitrate'],"['NOE supplementation', 'total energy', 'Time-to-fatigue', 'lactate threshold', 'enhanced muscle oxygen saturation (SmO 2 ) recovery', 'total work output']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0330391', 'cui_str': 'Beta vulgaris'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0574401', 'cui_str': 'Samoan language'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]",,0.194675,"The NOE supplementation resulted in a cyclist riding at higher cadence rates with lower absolute torque values at the same power during both the work and rest periods, which in-turn delayed over-all fatigue and improved total work output.","[{'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Broeder', 'Affiliation': 'Exercising Nutritionally, LLC, United States.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Flores', 'Affiliation': 'University of Wisconsin, United States.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Julian', 'Affiliation': 'Exercising Nutritionally, LLC, United States.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wojan', 'Affiliation': 'Exercising Nutritionally, LLC, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tauber', 'Affiliation': 'Northern Illinois University, United States.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Schubert', 'Affiliation': 'Exercising Nutritionally, LLC, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Salacinski', 'Affiliation': 'Exercising Nutritionally, LLC, United States.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Ivy', 'Affiliation': 'University of Texas at Austin, United States.'}]",Current research in physiology,['10.1016/j.crphys.2021.07.002']
2397,34746835,Effect of heat pre-conditioning on recovery following exercise-induced muscle damage.,"This study investigated the influence of heat pre-conditioning on the recovery of muscle torque, microvascular function, movement economy and stride mechanics following exercise-induced muscle damage (EIMD). Twenty male participants were equally assigned to a control (CON) and an experimental group (HEAT), and performed a 30-min downhill run (DHR) to elicit EIMD. HEAT group received three consecutive days of heat exposure (45.1 ​± ​3.2 ​min of hot water immersion at 42 ​°C) prior to DHR. Microvascular function (near-infrared spectroscopy), maximal voluntary contraction (MVC) torque of the knee extensors, as well as two treadmill-based steady-state runs performed below (SSR-1) and above (SSR-2) the first ventilatory threshold were assessed prior to DHR and repeated for four consecutive days post-DHR (D1-POST to D4-POST). The decline in MVC torque following EIMD was attenuated in HEAT compared with CON at D1-POST (p ​= ​0.037), D3-POST (p ​= ​0.002) and D4-POST (p ​= ​0.022). Muscle soreness increased in both CON and HEAT, but was significantly attenuated in HEAT compared with CON at D2-POST (p ​= ​0.024) and D3-POST (p ​= ​0.013). Microvascular function decreased in CON from D1-POST to D3-POST (p ​= ​0.009 to 0.018), and was lower compared with HEAT throughout D1-POST to D3-POST (p ​= ​0.003 to 0.017). Pre-heat treatment decreased the magnitude of strength loss and muscle soreness, as well as attenuated the decline in microvascular function following EIMD. Heat treatment appears a promising pre-conditioning strategy when embarking on intensified training periods or competition.",2021,"Muscle soreness increased in both CON and HEAT, but was significantly attenuated in HEAT compared with CON at D2-POST",['Twenty male participants'],"['control (CON) and an experimental group (HEAT), and performed a 30-min downhill run (DHR) to elicit EIMD', 'heat pre-conditioning', 'heat exposure (45.1\xa0\u200b±', 'D3-POST', 'CON at D2-POST', 'CON at D1-POST']","['strength loss and muscle soreness', 'recovery of muscle torque, microvascular function, movement economy and stride mechanics', 'Muscle soreness', 'MVC torque following EIMD', 'Microvascular function', 'Microvascular function (near-infrared spectroscopy), maximal voluntary contraction (MVC) torque of the knee extensors, as well as two treadmill-based steady-state runs performed below (SSR-1) and above (SSR-2) the first ventilatory threshold']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0239930', 'cui_str': 'Heat exposure'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",20.0,0.0134975,"Muscle soreness increased in both CON and HEAT, but was significantly attenuated in HEAT compared with CON at D2-POST","[{'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Sabapathy', 'Affiliation': 'Sport Physiology, Sport Science and Medicine, Singapore Sport Institute, Republic of Singapore.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Tan', 'Affiliation': 'Sport Physiology, Sport Science and Medicine, Singapore Sport Institute, Republic of Singapore.'}, {'ForeName': 'Shadiq', 'Initials': 'S', 'LastName': 'Al Hussein', 'Affiliation': 'Sport Physiology, Sport Science and Medicine, Singapore Sport Institute, Republic of Singapore.'}, {'ForeName': 'Haiyum', 'Initials': 'H', 'LastName': 'Jaafar', 'Affiliation': 'Football Science and Medicine, Football Association of Singapore, Republic of Singapore.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Brocherie', 'Affiliation': 'Laboratory Sport, Expertise and Performance (EA 7370), French Institute of Sport (INSEP), Paris, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Racinais', 'Affiliation': 'Research and Scientific Support, Aspetar Orthopaedic and Sports Medicine Hospital, Doha, Qatar.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Ihsan', 'Affiliation': 'Sport Physiology, Sport Science and Medicine, Singapore Sport Institute, Republic of Singapore.'}]",Current research in physiology,['10.1016/j.crphys.2021.06.002']
2398,34746815,"A comparison of pain responses, hemodynamic reactivity and fibre type composition between Bergström and microbiopsy skeletal muscle biopsies.","This study tested the hypotheses that 1) skeletal muscle biopsies performed with the Bergström needle evoke larger perceptions of pain and greater hemodynamic reactivity compared to biopsies performed with the microbiopsy needle, and 2) both needles yield samples with similar fibre type compositions when samples are collected at similar skeletal muscle depths. Fourteen healthy (age: 21.6 ± 3.2 years; VO 2 peak: 41.5 ± 5.8 mL/kg/min) males (n = 7) and females (n = 7) provided two resting skeletal muscle biopsies, one with each needle type, following a randomized crossover design. Participants completed the short-form McGill Pain Questionnaire and the Brief Pain Inventory before, during, and after the skeletal muscle biopsies. Hemodynamic reactivity was assessed by measuring heart rate (HR) and mean arterial pressure (MAP) at rest and during the biopsy procedures. Immunofluorescence analysis was used to assess fibre type composition in  vastus lateralis  samples. Compared to the microbiopsy needle, the Bergström needle elicited a larger perception of pain but similar hemodynamic reactivity during the biopsy. Both needles yielded skeletal muscle samples with similar fibre type composition and resulted in similar perceptions of pain and pain-related interference during the post-biopsy recovery period. Collectively, these findings suggest that studies should consider using the microbiopsy needle rather than the Bergström needle unless large amounts of muscle tissue or certain muscle fibre lengths are required. However, future work should determine whether our findings are generalizable to biopsies performed with different procedures and/or types of Bergström/microbiopsy needles.",2020,Both needles yielded skeletal muscle samples with similar fibre type composition and resulted in similar perceptions of pain and pain-related interference during the post-biopsy recovery period.,"['Fourteen healthy (age: 21.6\u202f±\u202f3.2 years; VO 2 peak: 41.5\u202f±\u202f5.8\u202fmL/kg/min) males (n\u202f=\u202f7) and females (n\u202f=\u202f7) provided two resting skeletal muscle biopsies, one with each needle type']",[],"['short-form McGill Pain Questionnaire and the Brief Pain Inventory', 'Hemodynamic reactivity', 'heart rate (HR) and mean arterial pressure (MAP', 'fibre type composition', 'pain and pain-related interference', 'pain responses, hemodynamic reactivity and fibre type composition']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2315740', 'cui_str': 'Biopsy of skeletal muscle'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",14.0,0.0392817,Both needles yielded skeletal muscle samples with similar fibre type composition and resulted in similar perceptions of pain and pain-related interference during the post-biopsy recovery period.,"[{'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Bonafiglia', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, K7L 3N6, Canada.""}, {'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Islam', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, K7L 3N6, Canada.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Preobrazenski', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, K7L 3N6, Canada.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Drouin', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, K7L 3N6, Canada.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ma', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, N2L 3G5, Canada.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Gerhart', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, K7L 3N6, Canada.""}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Quadrilatero', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, N2L 3G5, Canada.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Tschakovsky', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, K7L 3N6, Canada.""}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Tripp', 'Affiliation': ""Departments of Psychology, Anesthesiology and Urology, Queen's University, Kingston, Ontario, K7L 3N9, Canada.""}, {'ForeName': 'Christopher G R', 'Initials': 'CGR', 'LastName': 'Perry', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, Ontario, M3J 1P3, Canada.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Simpson', 'Affiliation': ""School of Medicine, Queen's University, Kingston, Ontario, K7L 3L4, Canada.""}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Gurd', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, K7L 3N6, Canada.""}]",Current research in physiology,['10.1016/j.crphys.2020.05.001']
2399,34746785,Comparison of efficacy and pain perception using 0.5% Bupivacaine and 2% Lidocaine in periodontal Surgery - A split mouth randomized clinical trial.,"Purpose


To evaluate the effectiveness of bupivacaine and lidocaine local anesthesia on the intra-surgical and post-surgical pain control in patients undergoing periodontal flap surgery.
Materials and methods


A randomized, single-blind, split-mouth design was employed in patients who are scheduled for periodontal flap surgery for at least two similar sextants with similar anesthetic techniques. Fifty patients (age range 16-65 years, 32 males and 28 females) enrolled in the present study. On one-site, the flap surgery was performed using 2% lidocaine with 1:200000 epinephrine and on the other with 0.5% bupivacaine with 1:200000 epinephrine. Base line clinical parameters, probing pocket depth, clinical attachment level were recorded. Pain during intra operative period, at the time of loss of numbness and for three consecutive days was measured using visual analog scale (VAS).
Results


Significant differences were observed between the two groups in the intra operative pain scores (p=0.0045) and pain scores at the time of loss of numbness (p=0.0005) but not at the 1st, 2nd and 3rd day after the surgery.
Conclusion


Bupivacaine was markedy more effective than the lidocaine. Thus the usage of bupivacaine can be substantiated for periodontal surgeries for the control of pain in the intra operative and immediate post-operative period to increase patients' comfort.",2021,"Results


Significant differences were observed between the two groups in the intra operative pain scores (p=0.0045) and pain scores at the time of loss of numbness (p=0.0005) but not at the 1st, 2nd and 3rd day after the surgery.
","['patients undergoing periodontal flap surgery', 'Fifty patients (age range 16-65 years, 32 males and 28 females) enrolled in the present study', 'patients who are scheduled for periodontal flap surgery for at least two similar sextants with similar anesthetic techniques']","['lidocaine local anesthesia', 'Bupivacaine', 'Bupivacaine and 2% Lidocaine', 'bupivacaine with 1:200000 epinephrine', 'lidocaine with 1:200000 epinephrine', 'bupivacaine', 'lidocaine']","['probing pocket depth, clinical attachment level', 'intra operative pain scores', 'pain scores', 'efficacy and pain perception', 'Pain', 'visual analog scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0636484,"Results


Significant differences were observed between the two groups in the intra operative pain scores (p=0.0045) and pain scores at the time of loss of numbness (p=0.0005) but not at the 1st, 2nd and 3rd day after the surgery.
","[{'ForeName': 'Shanmukha Srinivas Manikanta', 'Initials': 'SSM', 'LastName': 'Tirumalasetty', 'Affiliation': 'Department of Periodontics, GSL Dental College, Rajahmundry, India.'}, {'ForeName': 'Dwarakanath', 'Initials': 'D', 'LastName': 'Chinniswami Doraisami', 'Affiliation': 'Department of Periodontics, Vishnu Dental College, Bhimavaram,India.'}, {'ForeName': 'Santosh Venkata Ramesh', 'Initials': 'SVR', 'LastName': 'Konathala', 'Affiliation': 'Department of Periodontics, Vishnu Dental College, Bhimavaram,India.'}, {'ForeName': 'Subhadra Gautami', 'Initials': 'SG', 'LastName': 'Penmetsa', 'Affiliation': 'Department of Periodontics, Vishnu Dental College, Bhimavaram,India.'}, {'ForeName': 'Naga Venkata Satya Sai Sruthima', 'Initials': 'NVSSS', 'LastName': 'Gottumukkala', 'Affiliation': 'Department of Periodontics, Vishnu Dental College, Bhimavaram,India.'}]",European oral research,['10.26650/eor.2021853507']
2400,34746784,The effects of Biofreeze and superficial heat on masticatory myofascial pain syndrome.,"Purpose


This study aims to assess the influence of superficial heat and Biofreeze on pain, mouth opening (mm), and quality of life in patients with masticatory myofascial pain syndrome (MPS).
Materials and methods


52 patients with MPS were included in the study. They were randomly divided into two groups. Patients in the Biofreeze group (n = 26) applied 3.5% menthol gel to the masseter and temporal muscles twice a day for seven days, while the other group applied superficial heat. Baseline, 7th, and 21st days of VAS, mouth opening (mm), and Oral Health Impact Profile-14 (OHIP-14) scores of the patients were evaluated statistically.
Results


The mouth opening increased by 4.27 ± 3.80 mm in the Biofreeze group and 2.58 ± 2.16 mm in the superficial heat group. In each group, a significant decrease in VAS and OHIP-14 scores was observed on the 7th day compared to the baseline values (p<0.001). There was no statistically significant difference between the two applications on myofascial pain, mouth opening (mm), and OHIP-14 total score variables. The favorable effects of both applications on these parameters were limited to the duration of use.
Conclusion


Biofreeze and superficial heat in MPS were found to increase the quality of life, but the limited effectiveness of these applications underlines the importance of the underlying factors.",2021,"There was no statistically significant difference between the two applications on myofascial pain, mouth opening (mm), and OHIP-14 total score variables.","['masticatory myofascial pain syndrome', '52 patients with MPS', 'patients with masticatory myofascial pain syndrome (MPS']","['superficial heat and Biofreeze', 'menthol gel', 'Biofreeze and superficial heat']","['quality of life', 'myofascial pain, mouth opening (mm), and OHIP-14 total score variables', 'pain, mouth opening (mm), and quality of life', 'mouth opening', 'VAS and OHIP-14 scores', 'VAS, mouth opening (mm), and Oral Health Impact Profile-14 (OHIP-14) scores']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1815268', 'cui_str': 'Biofreeze'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",52.0,0.0126865,"There was no statistically significant difference between the two applications on myofascial pain, mouth opening (mm), and OHIP-14 total score variables.","[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Yaman', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Bolu Abant Izzet Baysal University, Bolu,Turkey.'}, {'ForeName': 'Cansu', 'Initials': 'C', 'LastName': 'Alpaslan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara,Turkey.'}, {'ForeName': 'Oya', 'Initials': 'O', 'LastName': 'Kalaycioglu', 'Affiliation': 'Department of Biostatistics and Medical Informatics, Faculty of Medicine, Bolu Abant Izzet Baysal University, Bolu,Turkey.'}]",European oral research,['10.26650/eor.2021858837']
2401,32562884,Effect of Human Central Nervous System Stem Cell Subretinal Transplantation on Progression of Geographic Atrophy Secondary to Nonneovascular Age-Related Macular Degeneration.,"PURPOSE


To evaluate the effect of subretinally transplanted human central nervous system stem cells (HuCNS-SC) on the progression of geographic atrophy (GA) in patients with nonneovascular age-related macular degeneration (AMD).
DESIGN


Multicenter, prospective, phase 1 open-label clinical trial.
PARTICIPANTS


Fifteen patients with bilateral GA solely the result of AMD.
METHODS


The eye with the worst best-corrected visual acuity from each patient was selected for treatment and was considered the study eye; fellow eyes served as controls. A total of 0.25 × 10 6  or 1.0 × 10 6  HuCNS-SCs were infused directly into the subretinal space, superotemporal to the fovea near the junctional zone, outside the area of GA. All patients underwent spectral-domain OCT and fundus autofluorescence imaging using the Spectralis HRA+OCT (Heidelberg Engineering, Inc., Heidelberg, Germany). Total GA area in both eyes was measured at baseline and month 12 by certified reading center graders using the Spectralis Region Finder software. Sectoral (clock hour) per directional radial GA progression rates with respect to the foveal center in both eyes were calculated using the polar transformation method in Image J software (National Institutes of Health, Bethesda, MD). To facilitate comparative analysis across the cohort, all eyes were transformed to a right-eye orientation.
MAIN OUTCOME MEASURES


Total GA area and sectoral per directional GA progression rates were compared in both study and control eyes.
RESULTS


No statistically significant difference was found in mean change in total GA area at month 12 between study and fellow eyes (1.07 ± 0.84 mm 2  vs. 2.08 ± 1.97 mm 2 ; P = 0.08). However, the month 12 sectoral per directional radial GA growth rate for the superotemporal region (i.e., the location of HuCNS-SC transplantation) showed a significantly slower progression rate in study eyes than in fellow eyes (0.29 ± 0.58 mm vs. 1.08 ± 0.65 mm; P = 0.007). The progression rate in the superotemporal quadrant of the study eye was significantly slower than in the other 3 quadrants combined (P = 0.04).
CONCLUSIONS


In this small pilot study, HuCNS-SC transplantation seems to be associated with slower expansion of the GA lesion in the transplanted quadrant. Larger confirmatory studies are required. Sectoral or directional analysis of growth rates of GA may be a useful approach for assessing the efficacy of locally delivered therapies.",2021,No statistically significant difference was found in mean change in total GA area at month 12 between study and fellow eyes (1.07 ± 0.84 mm 2  vs. 2.08 ± 1.97 mm 2 ; P = 0.08).,"['patients with nonneovascular age-related macular degeneration (AMD', 'Fifteen patients with bilateral GA solely the result of AMD']","['HuCNS-SC transplantation', 'subretinally transplanted human central nervous system stem cells (HuCNS-SC', 'Human Central Nervous System Stem Cell Subretinal Transplantation']","['geographic atrophy (GA', 'Sectoral (clock hour) per directional radial GA progression rates', 'directional radial GA growth rate', 'progression rate', 'Total GA area', 'Total GA area and sectoral per directional GA progression rates', 'mean change in total GA area']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271083', 'cui_str': 'Nonexudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C2699708', 'cui_str': 'Subretinal route'}]","[{'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0439741', 'cui_str': 'Sectoral'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",15.0,0.117868,No statistically significant difference was found in mean change in total GA area at month 12 between study and fellow eyes (1.07 ± 0.84 mm 2  vs. 2.08 ± 1.97 mm 2 ; P = 0.08).,"[{'ForeName': 'Muneeswar G', 'Initials': 'MG', 'LastName': 'Nittala', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Uji', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Swetha Bindu', 'Initials': 'SB', 'LastName': 'Velaga', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Hariri', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Naor', 'Affiliation': 'Kodiak Sciences, Palo Alto, California.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Birch', 'Affiliation': 'Retina Foundation of Southwest, Dallas, Texas.'}, {'ForeName': 'Rand', 'Initials': 'R', 'LastName': 'Spencer', 'Affiliation': 'Retina Foundation of Southwest, Dallas, Texas.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Leng', 'Affiliation': 'Byers Eye Institute at Stanford, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Capela', 'Affiliation': 'StemCells, Inc., Newark, California.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Tsukamoto', 'Affiliation': 'StemCells, Inc., Newark, California.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ip', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: ssadda@doheny.org.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.06.012']
2402,32572779,Effect of Electro-acupuncture on Expression of IRS-1/PI3K/GLUT4 Pathway in Ovarian Granulosa Cells of Infertile Patients with Polycystic Ovary Syndrome-Insulin Resistance of Phlegm-Dampness Syndrome.,"OBJECTIVE


To evaluate the effect of electro-acupuncture (EA) in infertile patients with phlegm-dampness polycystic ovary syndrome-insulin resistance (PCOS-IR).
METHODS


Seventy-six PCOS-IR patients who underwnet in vitro fertilization and embryo transfer (IVF-ET) were equally assigned to two groups according to a random digital table: the EA group and the control group, with 38 cases in each group. Before undergoing IVF, the two groups were treated with EA or pseudo-acupuncture, respectively, for 3 menstrual cycles. The intervention was 25 min twice a week until the day of oocyte collection. The selected acupoints were Zhongwan (RN 12), Tianshu (ST 25), Daheng (SP 15), Daimai (GB 26), Qihai (CV 6), Guanyuan (CV 4), and bilateral points including Xuehai (SP 10), Fenglong (ST 40), Zusanli (ST 36), and Yinlingquan (SP 9). Evaluation of phlegm-dampness syndrome score and IR score were carried out before and after treatment. Additionally, the number of oocytes retrieved, transplantable embryo rate, high-quality embryo rate, clinical pregnancy rate and live birth rate were compared between the two groups. Real-time polymerase chain reaction analysis was used to monitor the mRNA expression of the insulin receptor substrate (IRS-1), phosphatidylinositiol 3-kinase (PI3K) and glucose transport factor 4 (GLUT4) in ovarian granulosa cells.
RESULTS


EA treatment reduced the phlegm-dampness syndrome score as well as the IR scores compared with the control group (P<0.05). No significant differences in the number of oocytes retrieved and clinical pregnancy rate between the two groups (P>0.05). Moreover, the transplantable embryo rate [49.0% (284/580) vs. 41.9% (273/652)], high-quality embryo rate [36.6% (104/284) vs. 27.8% (76/273)], and live birth rate [50% (19/38) vs. 26.3% (10/38)] in the EA group were significantly higher than in the control group (P<0.05). Gene expression analyses revealed significantly elevated IRS-1, PI3K and GLUT4 mRNA in ovarian granulosa cells of the EA group compared with the control group (P<0.05).
CONCLUSIONS


EA may ameliorate the effects of phlegm-dampness syndrome and ovarian IR in PCOS-IR patients. Mechanistically, this effect might be through an upregulation of the IRS-1/PI3K/GLUT4 signaling pathway, which may result in improved oocyte quality and embryonic development potential. (Registration No. ChiCTR1800015453).",2021,No significant differences in the number of oocytes retrieved and clinical pregnancy rate between the two groups (P>0.05).,"['Seventy-six PCOS-IR patients who underwnet in vitro fertilization and embryo transfer (IVF-ET', 'infertile patients with phlegm-dampness polycystic ovary syndrome-insulin resistance (PCOS-IR', 'Infertile Patients with Polycystic Ovary Syndrome-Insulin Resistance of Phlegm-Dampness Syndrome']","['EA or pseudo-acupuncture', 'Electro-acupuncture', 'electro-acupuncture (EA']","['number of oocytes retrieved, transplantable embryo rate, high-quality embryo rate, clinical pregnancy rate and live birth rate', 'high-quality embryo rate', 'Expression of IRS-1/PI3K', 'PI3K) and glucose transport factor 4 (GLUT4) in ovarian granulosa cells', 'live birth rate', 'number of oocytes retrieved and clinical pregnancy rate', 'transplantable embryo rate', 'mRNA expression of the insulin receptor substrate (IRS-1), phosphatidylinositiol 3-kinase', 'elevated IRS-1, PI3K and GLUT4 mRNA in ovarian granulosa cells', 'phlegm-dampness syndrome score', 'IR scores']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205237', 'cui_str': 'False'}]","[{'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0034818', 'cui_str': 'Insulin receptor'}, {'cui': 'C0123658', 'cui_str': 'Insulin Receptor Substrate-1'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",76.0,0.0997937,No significant differences in the number of oocytes retrieved and clinical pregnancy rate between the two groups (P>0.05).,"[{'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Xiang', 'Affiliation': 'Gynecology of Traditional Chinese Medicine, the First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, 250355, China.'}, {'ForeName': 'Ming-Feng', 'Initials': 'MF', 'LastName': 'Xia', 'Affiliation': 'Experimental Center, Shandong University of Traditional Chinese Medicine, Jinan, 250355, China.'}, {'ForeName': 'Jing-Yan', 'Initials': 'JY', 'LastName': 'Song', 'Affiliation': 'Gynecology of Traditional Chinese Medicine, the First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, 250355, China.'}, {'ForeName': 'Dan-Qi', 'Initials': 'DQ', 'LastName': 'Liu', 'Affiliation': 'Gynecology of Traditional Chinese Medicine, the First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, 250355, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': 'Reproductive and Genetic Center of Integrated Traditional and Western Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250011, China. lianfangbangong@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3219-z']
2403,32594774,Validity and Responsiveness of the Glittre-ADL Test without a Backpack in People with Chronic Obstructive Pulmonary Disease.,"The Glittre-ADL test assesses the functional capacity for activities of daily living of people with chronic obstructive pulmonary disease (COPD). In the test, a weighted backpack is worn (2.5 kg for women and 5.0 kg for men). The differential in weight between men and women is not common in other tests of exercise capacity and may limit the comparison of the test between sexes. The primary aim of this study was to validate the Glittre-ADL test performed without the backpack in people with COPD. Forty participants with mild to severe COPD (mean ± SD age: 70 ± 6 years; FEV 1 : 48 ± 20%predicted) were recruited and performed two six-minute walk tests (visit 1); two Glittre-ADL tests with backpack (visit 2), and the Glittre-ADL test with and without the backpack, in random order (visit 3). The Glittre-ADL test time was shorter without the backpack than with the backpack [mean difference -0.37 min (95%CI -0.59 to -0.15)] and heart rate (HR) and oxygen saturation (SpO 2 ) were equivalents between tests [-1.31 beats/minute (-3.92 to 1.30) and -0.95% (-2.27 to 0.37), respectively]. The Glittre-ADL test without the backpack elicited similar HR and SpO2 responses as the test with the backpack, indicating equivalence of physiological demand. Thus, the Glittre-ADL test without the backpack was a valid, responsive, and appropriate test to assess functional capacity for activities of daily living.",2020,"The Glittre-ADL test time was shorter without the backpack than with the backpack [mean difference -0.37 min (95%CI -0.59 to -0.15)] and heart rate (HR) and oxygen saturation (SpO 2 ) were equivalents between tests [-1.31 beats/minute (-3.92 to 1.30) and -0.95% (-2.27 to 0.37), respectively].","['people with COPD', 'Forty participants with mild to severe COPD (mean\u2009±\u2009SD age: 70\u2009±\u20096\u2009years; FEV 1 : 48\u2009±\u200920%predicted', 'People with Chronic Obstructive Pulmonary Disease', 'people with chronic obstructive pulmonary disease (COPD']","['Glittre-ADL tests with backpack (visit 2), and the Glittre-ADL test with and without the backpack', 'Glittre-ADL Test without a Backpack']","['Glittre-ADL test time', 'heart rate (HR) and oxygen saturation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",40.0,0.278793,"The Glittre-ADL test time was shorter without the backpack than with the backpack [mean difference -0.37 min (95%CI -0.59 to -0.15)] and heart rate (HR) and oxygen saturation (SpO 2 ) were equivalents between tests [-1.31 beats/minute (-3.92 to 1.30) and -0.95% (-2.27 to 0.37), respectively].","[{'ForeName': 'Liliane P de Souza', 'Initials': 'LPS', 'LastName': 'Mendes', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Verônica Franco', 'Initials': 'VF', 'LastName': 'Parreira', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Lissa M', 'Initials': 'LM', 'LastName': 'Spencer', 'Affiliation': 'Department of Physiotherapy, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Danielle Soares Rocha', 'Initials': 'DSR', 'LastName': 'Vieira', 'Affiliation': 'Faculty of Health Sciences, Universidade Federal de Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Jennifer Ailsey', 'Initials': 'JA', 'LastName': 'Alison', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.'}]",COPD,['10.1080/15412555.2020.1756236']
2404,34446763,A prospective cohort study on longitudinal trajectories of cognitive function after stroke.,"The study aimed to determine longitudinal trajectories of cognitive function during the first year after stroke. The Montreal Cognitive Assessment (MoCA) was used to screen cognitive function at 36-48 h, 3-months, and 12-months post-stroke. Individuals who shared similar trajectories were classified by applying the group-based trajectory models. Data from 94 patients were included in the analysis. Three cognitive functioning groups were identified by the trajectory models: high [14 patients (15%)], medium [58 (62%)] and low [22 (23%)]. For the high and medium groups, cognitive function improved at 12 months, but this did not occur in the low group. After age, sex and education matching to the normative MoCA from the Swedish population, 52 patients (55%) were found to be cognitively impaired at baseline, and few patients had recovered at 12 months. The impact on memory differs between cognitive functioning groups, whereas the impact on activities of daily living was not different. Patients with the poorest cognitive function did not improve at one-year poststroke and were prone to severe memory problems. These findings may help to increase focus on long-term rehabilitation plans for those patients, and more accurately assess their needs and difficulties experienced in daily living.",2021,"For the high and medium groups, cognitive function improved at 12 months, but this did not occur in the low group.",['94 patients were included in the analysis'],[],"['activities of daily living', 'Montreal Cognitive Assessment (MoCA', 'cognitive function', 'severe memory problems']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0233794', 'cui_str': 'Memory impairment'}]",94.0,0.0141035,"For the high and medium groups, cognitive function improved at 12 months, but this did not occur in the low group.","[{'ForeName': 'Dongni', 'Initials': 'D', 'LastName': 'Buvarp', 'Affiliation': 'Rehabilitation Medicine Research Group, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden. dongni.buvarp@gu.se.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Rafsten', 'Affiliation': 'Rehabilitation Medicine Research Group, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Abzhandadze', 'Affiliation': 'Rehabilitation Medicine Research Group, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Katharina S', 'Initials': 'KS', 'LastName': 'Sunnerhagen', 'Affiliation': 'Rehabilitation Medicine Research Group, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}]",Scientific reports,['10.1038/s41598-021-96347-y']
2405,34656227,"Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial.","BACKGROUND


No phase 3 trial has yet shown improved survival for patients with pleural or peritoneal malignant mesothelioma who have progressed following platinum-based chemotherapy. The aim of this study was to assess the efficacy and safety of nivolumab, an anti-PD-1 antibody, in these patients.
METHODS


This was a multicentre, placebo-controlled, double-blind, parallel group, randomised, phase 3 trial done in 24 hospitals in the UK. Adult patients (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1, with histologically confirmed pleural or peritoneal mesothelioma, who had received previous first-line platinum-based chemotherapy and had radiological evidence of disease progression, were randomly assigned (2:1) to receive nivolumab at a flat dose of 240 mg every 2 weeks over 30 min intravenously or placebo until disease progression or a maximum of 12 months. The randomisation sequence was generated within an interactive web response system (Alea); patients were stratified according to epithelioid versus non-epithelioid histology and were assigned in random block sizes of 3 and 6. Participants and treating clinicians were masked to group allocation. The co-primary endpoints were investigator-assessed progression-free survival and overall survival, analysed according to the treatment policy estimand (an equivalent of the intention-to-treat principle). All patients who were randomly assigned were included in the safety population, reported according to group allocation. This trial is registered with Clinicaltrials.gov, NCT03063450.
FINDINGS


Between May 10, 2017, and March 30, 2020, 332 patients were recruited, of whom 221 (67%) were randomly assigned to the nivolumab group and 111 (33%) were assigned to the placebo group). Median follow-up was 11·6 months (IQR 7·2-16·8). Median progression-free survival was 3·0 months (95% CI 2·8-4·1) in the nivolumab group versus 1·8 months (1·4-2·6) in the placebo group (adjusted hazard ratio [HR] 0·67 [95% CI 0·53-0·85; p=0·0012). Median overall survival was 10·2 months (95% CI 8·5-12·1) in the nivolumab group versus 6·9 months (5·0-8·0) in the placebo group (adjusted HR 0·69 [95% CI 0·52-0·91]; p=0·0090). The most frequently reported grade 3 or worse treatment-related adverse events were diarrhoea (six [3%] of 221 in the nivolumab group vs two [2%] of 111 in the placebo group) and infusion-related reaction (six [3%] vs none). Serious adverse events occurred in 90 (41%) patients in the nivolumab group and 49 (44%) patients in the placebo group. There were no treatment-related deaths in either group.
INTERPRETATION


Nivolumab represents a treatment that might be beneficial to patients with malignant mesothelioma who have progressed on first-line therapy.
FUNDING


Stand up to Cancer-Cancer Research UK and Bristol Myers Squibb.",2021,Median overall survival was 10·2 months (95% CI 8·5-12·1) in the nivolumab group versus 6·9 months (5·0-8·0) in the placebo group (adjusted HR 0·69,"['Between May 10, 2017, and March 30, 2020', '332 patients were recruited, of whom 221 (67', 'Adult patients (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1, with histologically confirmed pleural or peritoneal mesothelioma, who had received previous first-line platinum-based chemotherapy and had radiological evidence of disease progression', '24 hospitals in the UK', 'patients with pleural or peritoneal malignant mesothelioma who have progressed following platinum-based chemotherapy', 'patients with malignant mesothelioma who have progressed on first-line therapy', 'patients with relapsed malignant mesothelioma (CONFIRM']","['nivolumab', 'placebo', 'nivolumab at a flat dose of 240 mg every 2 weeks over 30 min intravenously or placebo', 'Nivolumab versus placebo']","['Median overall survival', 'Serious adverse events', 'survival', 'Median progression-free survival', 'diarrhoea', 'investigator-assessed progression-free survival and overall survival', 'efficacy and safety']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0346109', 'cui_str': 'Mesothelioma of peritoneum'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0345967', 'cui_str': 'Mesothelioma, malignant'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0278753', 'cui_str': 'Mesothelioma malignant recurrent'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",332.0,0.909673,Median overall survival was 10·2 months (95% CI 8·5-12·1) in the nivolumab group versus 6·9 months (5·0-8·0) in the placebo group (adjusted HR 0·69,"[{'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': 'Mesothelioma Research Programme, Leicester Cancer Research Centre, University of Leicester, Leicester, UK; University Hospitals of Leicester NHS Trust, Leicester, UK. Electronic address: df132@le.ac.uk.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Ewings', 'Affiliation': 'Cancer Research UK, Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ottensmeier', 'Affiliation': 'Department of Molecular & Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Califano', 'Affiliation': 'Department of Medical Oncology, Wythenshaw Hospital, Manchester, UK.'}, {'ForeName': 'Gerard G', 'Initials': 'GG', 'LastName': 'Hanna', 'Affiliation': 'Peter MacCullum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Kayleigh', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'Cancer Research UK, Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Danson', 'Affiliation': 'Department of Radiation Oncology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Steele', 'Affiliation': 'Department of Oncology and Metabolism University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Mavis', 'Initials': 'M', 'LastName': 'Nye', 'Affiliation': 'Mavis Nye Foundation, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Cancer Research UK, Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lord', 'Affiliation': 'Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Calley', 'Initials': 'C', 'LastName': 'Middleton', 'Affiliation': 'Cancer Research UK, Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szlosarek', 'Affiliation': 'Cancer Research UK Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'York Teaching Hospital NHS Foundation Trust, York, UK.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Gaba', 'Affiliation': 'Mesothelioma Research Programme, Leicester Cancer Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Darlison', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK; Department of Oncology, Mesothelioma UK, Leicester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wells-Jordan', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Richards', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Poile', 'Affiliation': 'Mesothelioma Research Programme, Leicester Cancer Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Lester', 'Affiliation': 'The Rutherford Cancer Centre, Newport, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Cancer Research UK, Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00471-X']
2406,34664380,Open versus laparoscopic lateral lymph node dissection for mid- and low- rectal cancer: a propensity score matching study.,"BACKGROUND


This study aimed to evaluate the perioperative, pathological and oncological outcomes of open versus laparoscopic total mesorectal excision (TME) plus lateral lymph node dissection (LLND) for mid- and low- rectal cancer using propensity score matching.
METHODS


Between September 2009 and December 2018, consecutive patients who underwent open or laparoscopic TME plus LLND were collected. Based on the propensity score matching analysis, laparoscopic TME plus LLND was compared with open TME plus LLND for the perioperative, pathological, and oncological outcomes.
RESULTS


A total of 77 patients were collected. There were 13 patients who underwent open TME plus LLND (open group) and 64 patients who underwent laparoscopic TME plus LLND (laparoscopic group). After propensity score matching, 13 patients in the open group were matched to 39 patients in the laparoscopic group (1:3). The laparoscopic group had a significantly shorter length of incision (5 cm vs. 20 cm, p < 0.01), less intraoperative blood loss (80 mL vs. 100 mL, p = 0.02), and shorter time to postoperative liquid diet (72 h vs. 96 h, p = 0.05). There were no significant differences in both early and late postoperative complications. The 3-year overall survival was 85.9% in the laparoscopic group and 76.9% in the open group (p = 0.75), respectively. The 3-year disease-free survival was 70.6% in the laparoscopic group and 74.1% in the open group (p = 0.83), respectively.
CONCLUSION


Laparoscopic LLND had comparable oncological outcomes to open LLND. Moreover, laparoscopic LLND had postoperative recovery advantages over open LLND.",2021,"The laparoscopic group had a significantly shorter length of incision (5 cm vs. 20 cm, p < 0.01), less intraoperative blood loss (80 mL vs. 100 mL, p = 0.02), and shorter time to postoperative liquid diet (72 h vs. 96 h, p = 0.05).","['Between September 2009 and December 2018, consecutive patients who underwent open or', 'A total of 77 patients were collected', 'mid- and low- rectal cancer', '13 patients who underwent']","['laparoscopic LLND', 'open TME plus LLND', 'laparoscopic TME plus LLND', 'laparoscopic total mesorectal excision (TME) plus lateral lymph node dissection (LLND', 'laparoscopic lateral lymph node dissection', 'Laparoscopic LLND']","['shorter time to postoperative liquid diet', 'shorter length of incision', '3-year overall survival', '3-year disease-free survival', 'intraoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",77.0,0.0926696,"The laparoscopic group had a significantly shorter length of incision (5 cm vs. 20 cm, p < 0.01), less intraoperative blood loss (80 mL vs. 100 mL, p = 0.02), and shorter time to postoperative liquid diet (72 h vs. 96 h, p = 0.05).","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xuyang', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Research Management, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhuang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Mingtian', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wenjian', 'Initials': 'W', 'LastName': 'Meng', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiangbing', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}]",ANZ journal of surgery,['10.1111/ans.17252']
2407,34670713,Corrigendum to 'Effects of a projector-based hybrid virtual reality on pain in young children with burn injuries during hydrotherapy sessions: A within-subject randomized crossover trial'[Burns 46 (2020) 1571-1584].,,2020,,['young children with burn injuries during hydrotherapy sessions'],"[""trial'[Burns 46"", 'projector-based hybrid virtual reality']",[],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C3856907', 'cui_str': 'Projector'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]",[],,0.0389874,,"[{'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Khadra', 'Affiliation': 'University of Montreal, 2375, Chemin de la Côte-Ste-Catherine, Montreal (Quebec) H3T 1A8, Canada; CHU Sainte-Justine Research Center, 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Ballard', 'Affiliation': 'University of Montreal, 2375, Chemin de la Côte-Ste-Catherine, Montreal (Quebec) H3T 1A8, Canada; CHU Sainte-Justine Research Center, 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paquin', 'Affiliation': ""Department in Creation and New Media, Université du Québec en Abitibi-Témiscamingue, Campus Rouyn-Noranda, 445, boul. de l'Université, Rouyn-Noranda (Quebec) J9X 5E4, Canada.""}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Cotes-Turpin', 'Affiliation': ""Department in Creation and New Media, Université du Québec en Abitibi-Témiscamingue, Campus Rouyn-Noranda, 445, boul. de l'Université, Rouyn-Noranda (Quebec) J9X 5E4, Canada.""}, {'ForeName': 'Hunter G', 'Initials': 'HG', 'LastName': 'Hoffman', 'Affiliation': 'Department of Mechanical Engineering, University of Washington, 3900 E Stevens Way NE, Seattle, WA 98195, USA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Perreault', 'Affiliation': 'Department of Surgery, CHU Sainte-Justine, 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada.'}, {'ForeName': 'Jean-Simon', 'Initials': 'JS', 'LastName': 'Fortin', 'Affiliation': 'Emergency Department, Hôpital de Granby, 205 Boulevard Leclerc O, Granby (Quebec) J2G 1T7, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bouchard', 'Affiliation': 'Department of Psychoeducation and Psychology, Université du Québec en Outaouais, 283, boulevard Alexandre-Taché, Gatineau (Quebec) J9A 1L8, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Théroux', 'Affiliation': 'Murdoch University, 90 South Street, Murdoch, Western Australia 6150, Australia.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Le May', 'Affiliation': 'University of Montreal, 2375, Chemin de la Côte-Ste-Catherine, Montreal (Quebec) H3T 1A8, Canada; CHU Sainte-Justine Research Center, 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada. Electronic address: sylvie.lemay@umontreal.ca.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.12.001']
2408,34741929,Polyvascular disease and increased risk of cardiovascular events in patients with type 2 diabetes: Insights from the EXSCEL trial.,"BACKGROUND AND AIMS


Polyvascular disease is an independent predictor of major adverse cardiovascular events (MACE). The relationship between the number of diseased arterial beds and MACE is unknown. How MACE risk changes in individuals with type 2 diabetes (T2D) is also understudied. Furthermore, it is unknown whether heart failure (HF) status and hemoglobin A1c (HbA1c) levels influence outcomes in polyvascular disease. This analysis from the Exenatide Study of Cardiovascular Event Lowering trial (EXSCEL) aimed to examine the risk associated with increasing number of diseased arterial beds on MACE and all-cause mortality (ACM).
METHODS


Cox models were used to test associations between the number of diseased arterial beds and MACE and ACM. Prespecified interaction testing between number of diseased arterial beds with baseline HF, HbA1c (≤8% vs. >8%), and treatment assignment was performed.
RESULTS


Overall, 14,751 participants were included; 26.5% were without atherosclerosis, 58.9% had 1-bed, 12.3% had 2-bed, and 2.3% had 3-bed disease. An increasing burden of atherosclerotic disease was associated with increasing risk of MACE (adjusted HR [aHR] 1.71 [95% CI 1.46-2.02]; 2.61 [2.17-3.15]; 3.46 [2.69-4.45] for 1, 2, and 3 beds, respectively, p < 0.001 for all) and ACM (1.94 [1.56-2.42]; 3.03 [2.33-3.95]; 3.66 [2.59-5.18] for 1, 2, and 3 beds, respectively, p < 0.001 for all). Prespecified interaction testing did not reveal any significant associations.
CONCLUSIONS


In patients with T2D, compared to those without atherosclerotic vascular disease, risk of MACE and ACM increases incrementally with each additional diseased arterial bed.",2021,An increasing burden of atherosclerotic disease was associated with increasing risk of MACE (adjusted HR [aHR] 1.71,"['individuals with type 2 diabetes (T2D', '14,751 participants were included; 26.5% were without atherosclerosis, 58.9% had 1-bed, 12.3% had 2-bed, and 2.3% had 3-bed disease', 'patients with type 2 diabetes']",[],"['risk of cardiovascular events', 'burden of atherosclerotic disease', 'atherosclerotic vascular disease, risk of MACE and ACM']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",14751.0,0.29426,An increasing burden of atherosclerotic disease was associated with increasing risk of MACE (adjusted HR [aHR] 1.71,"[{'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Samsky', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA. Electronic address: marc.samsky@duke.edu.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stebbins', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Aaron W', 'Initials': 'AW', 'LastName': 'Aday', 'Affiliation': 'Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Pagidipati', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jorge Antonio', 'Initials': 'JA', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2021.10.011']
2409,34741917,Effects of peer learning on nursing students' learning outcomes in electrocardiogram education.,"BACKGROUND


Nurses should have the ability to interpret electrocardiograms (ECGs) quickly and accurately, but their ECG interpretation skills may be suboptimal. The best evidence for effective teaching methods is lacking.
OBJECTIVES


This study aimed to compare the effects of peer and self-directed individual learning methods on nursing students' learning flow, interpretation skills, and self-confidence in web-based ECG education.
DESIGN


This study employed a nonequivalent control group with a pretest-posttest design.
SETTINGS


This study was conducted at two colleges of nursing in the Republic of Korea.
PARTICIPANTS


Nursing students were conveniently assigned to either a peer learning group (n = 45) or a self-directed individual learning group (n = 51).
METHODS


A self-administered questionnaire was used to measure the nursing students' learning flow and self-confidence in ECG rhythm interpretation. ECG interpretation skills were measured using a web-based interpretation skills test. Data were analyzed using a paired t-test and a two-sample t-test.
RESULTS


Nursing students in both groups showed improved learning flow, interpretation skills, and self-confidence after ECG education compared with before learning. However, there were no significant pretest-posttest differences in learning flow, interpretation skills, or self-confidence between the two groups.
CONCLUSIONS


Peer learning was as effective as self-directed individual learning in improving nursing students' learning flow, interpretations skills, and self-confidence in web-based education. Nurse educators should educate nursing students to have optimal ECG interpretation abilities, and web-based peer or individual learning are effective education methods.",2021,"CONCLUSIONS


Peer learning was as effective as self-directed individual learning in improving nursing students' learning flow, interpretations skills, and self-confidence in web-based education.","['nursing students', 'two colleges of nursing in the Republic of Korea', ""nursing students' learning outcomes in electrocardiogram education"", 'Nursing students']","['peer learning', 'Peer learning', 'peer learning group (n\xa0=\xa045) or a self-directed individual learning group (n\xa0=\xa051', 'peer and self-directed individual learning methods']","['learning flow, interpretation skills, or self-confidence', 'ECG interpretation skills', 'learning flow, interpretation skills, and self-confidence', 'learning flow, interpretation skills, and self-confidence after ECG education']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0438154', 'cui_str': 'ECG finding'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.0662602,"CONCLUSIONS


Peer learning was as effective as self-directed individual learning in improving nursing students' learning flow, interpretations skills, and self-confidence in web-based education.","[{'ForeName': 'Youngmin', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'Graduate School of Nursing and Health Professions, Chung-Ang University, Seoul, Republic of Korea.'}, {'ForeName': 'S Barry', 'Initials': 'SB', 'LastName': 'Issenberg', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Young Sook', 'Initials': 'YS', 'LastName': 'Roh', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, 84 Heukseok-ro Dongjak-gu, Seoul 06974, Republic of Korea. Electronic address: aqua@cau.ac.kr.'}]",Nurse education today,['10.1016/j.nedt.2021.105182']
2410,34742140,Efficacy of primary prevention of venous thromboembolism among subgroups of cancer patients undergoing chemotherapy: A post- hoc analysis of the AVERT trial.,"BACKGROUND


Apixaban has been shown to significantly decrease the rate of VTE among intermediate-to-high risk patients starting chemotherapy compared to placebo. This investigation sought to determine the impact of apixaban among different subgroups of patients with cancer.
METHODS


This is a pre-planned post-hoc analysis of the AVERT randomized controlled trial which compared apixaban to placebo for the primary prevention of VTE in ambulatory patients initiating chemotherapy. Subgroup analyses were performed based on different baseline characteristics. The primary efficacy outcome was objectively documented major VTE. Hazard ratios (HR) with 95% confidence intervals (CI) were calculated using the Cox proportional hazards model to compare the treatment effect accounting for clustering at study center level.
RESULTS


During the study period, major VTE events occurred in 4.2% and 10.2% of the apixaban and placebo groups, respectively (HR 0.41; 95%CI, 0.26-0.65). Characteristics associated with decreased risk of major VTE among patients on apixaban included: male sex (HR 0.25, 95%CI 0.12-0.48); weight > 90Kg (HR 0.18, 95%CI, 0.06-0.52); no prior history of VTE (HR 0.41, 95%CI 0.26-0.64); solid cancers (HR 0.30; 95%CI, 0.19-0.47); metastatic disease (HR 0.45; 95%CI, 0.26-0.78); and concurrent use of antiplatelet therapy (HR 0.18, 95%CI 0.10-0.33).
CONCLUSIONS


In the AVERT trial, while apixaban thromboprophylaxis reduced the risk of major VTE in most patients, patients with weight > 90 kg, solid cancers, or concurrent antiplatelet therapy experienced the greatest benefits.",2021,"In the AVERT trial, while apixaban thromboprophylaxis reduced the risk of major VTE in most patients, patients with weight > 90 kg, solid cancers, or concurrent antiplatelet therapy","['ambulatory patients initiating chemotherapy', 'patients with cancer', 'subgroups of cancer patients undergoing']","['apixaban', 'apixaban to placebo', 'antiplatelet therapy', 'apixaban thromboprophylaxis', 'chemotherapy', 'placebo']","['major VTE events', 'major VTE', 'rate of VTE', 'risk of major VTE', 'metastatic disease', 'Hazard ratios (HR']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.461488,"In the AVERT trial, while apixaban thromboprophylaxis reduced the risk of major VTE in most patients, patients with weight > 90 kg, solid cancers, or concurrent antiplatelet therapy","[{'ForeName': 'Ameeta L', 'Initials': 'AL', 'LastName': 'Nayak', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Zahrai', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Tzu-Fei', 'Initials': 'TF', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Delluc', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Lana A', 'Initials': 'LA', 'LastName': 'Castellucci', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: pwells@toh.ca.'}]",Thrombosis research,['10.1016/j.thromres.2021.10.018']
2411,34742002,"Multisystemic Therapy - Building Stronger Families (MST-BSF): Substance misuse, child neglect, and parenting outcomes from an 18-month randomized effectiveness trial.","BACKGROUND


Parental substance misuse impacts millions of children globally and is a major determinant of repeat maltreatment and out-of-home placement. There is little published research on family-based, comprehensive treatment models that simultaneously address parental substance misuse and child maltreatment.
OBJECTIVE


This study reports outcomes from a randomized clinical trial examining the effectiveness of the Multisystemic Therapy - Building Stronger Families (MST-BSF) treatment model with families involved with Child Protective Services due to physical abuse and/or neglect plus parental substance misuse.
PARTICIPANTS AND SETTING


Ninety-eight families who had an open case with Child Protective Services in two areas of the state of Connecticut participated.
METHOD


Families referred by the Connecticut Department of Children and Families were randomly assigned to MST-BSF or Comprehensive Community Treatment (CCT). Both interventions were delivered by community-based therapists. Outcomes were measured across 5 assessments extending 18 months post-baseline.
RESULTS


Intent-to-treat analyses showed that MST-BSF was significantly more effective than CCT in reducing parent self-reported alcohol and opiate use and in improving child-reported neglectful parenting. Although means were in predicted directions, new incidents of abuse across 18 months did not differ between groups. The study features high recruitment and engagement rates for a population experiencing multiple involvements with child protection.
CONCLUSION


The outcomes of this study support the effectiveness of MST-BSF, an intensive family- and ecologically- based treatment, for significantly reducing parental alcohol and opiate misuse and child neglect. These findings help in our understanding of how best to address the understudied issue of interventions for child neglect.",2021,"RESULTS


Intent-to-treat analyses showed that MST-BSF was significantly more effective than CCT in reducing parent self-reported alcohol and opiate use and in improving child-reported neglectful parenting.","['families involved with Child Protective Services due to physical abuse and/or neglect plus parental substance misuse', 'population experiencing multiple involvements with child protection', 'Ninety-eight families who had an open case with Child Protective Services in two areas of the state of Connecticut participated', 'Families referred by the Connecticut Department of Children and Families']","['Multisystemic Therapy - Building Stronger Families (MST-BSF', 'CCT', 'MST-BSF or Comprehensive Community Treatment (CCT', 'MST-BSF']",['parental alcohol and opiate misuse and child neglect'],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1621955', 'cui_str': 'Physical abuse'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009778', 'cui_str': 'Connecticut'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C3840203', 'cui_str': 'Multisystemic therapy'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1834582', 'cui_str': 'Transient abnormal myelopoiesis'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1997897', 'cui_str': 'Opiate misuse'}, {'cui': 'C0553726', 'cui_str': 'Victim of child neglect'}]",98.0,0.0862813,"RESULTS


Intent-to-treat analyses showed that MST-BSF was significantly more effective than CCT in reducing parent self-reported alcohol and opiate use and in improving child-reported neglectful parenting.","[{'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Schaeffer', 'Affiliation': 'Division of Child and Adolescent Psychiatry, University of Maryland Baltimore, 737 W. Lombard St. 4th Floor, Baltimore, MD 21201, United States of America. Electronic address: cschaeff@som.umaryland.edu.'}, {'ForeName': 'Cynthia Cupit', 'Initials': 'CC', 'LastName': 'Swenson', 'Affiliation': 'Division of Global and Community Health, 176 Croghan Spur, Suite 104, Charleston, SC, 29407, United States of America.'}, {'ForeName': 'Jennifer Smith', 'Initials': 'JS', 'LastName': 'Powell', 'Affiliation': 'Division of Global and Community Health, 176 Croghan Spur, Suite 104, Charleston, SC, 29407, United States of America.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.105379']
2412,34746745,Suppression of ovulation and pharmacokinetics following subcutaneous administration of various doses of Depo-Provera®: a randomized trial.,"OBJECTIVES


To identify the lowest dose of Depo-Provera that, when administered off-label subcutaneously, suppressed ovulation and had a pharmacokinetic profile consistent with a 4-month contraceptive effect.
STUDY DESIGN


We conducted a randomized, multicenter, parallel-group study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of medroxyprogesterone acetate (MPA) after subcutaneous injection of three different doses of Depo-Provera. We randomized sixty women between 18 and 40 years of age at low risk of pregnancy with confirmed ovulation and body mass index of 18 to 35 kg/m 2  to receive a single injection of 45, 75 or 105 mg of Depo-Provera, or a single injection of Depo-subQ provera 104 as a reference drug (15 women per group) and followed them for 7.5 months. We evaluated suppression of ovulation as the primary outcome, and MPA concentrations, pharmacokinetic parameters, safety, and local tolerability as secondary outcomes.
RESULTS


Five women ovulated within four months of treatment initiation (three in the 45 mg group and two in the 75 mg group). MPA levels associated with ovulation were in general low, largely ≤ 0.2 ng/mL (the presumed contraceptive threshold). No women in either the 105 mg group or the Depo-subQ provera 104 group ovulated within four months. The PK parameters including C max , C 119 , and AUC 0-119  for these 2 groups were similar but not equivalent.
CONCLUSION


A dose of 105 mg of Depo-Provera injected subcutaneously was the lowest tested dose that consistently suppressed ovulation and maintained serum MPA levels consistent with contraceptive effect for at least 4 months. The PK and PD results for the 105 mg dose were similar to Depo-subQ provera 104 over this period.",2021,No women in either the 105 mg group or the Depo-subQ provera 104 group ovulated within four months.,"['sixty women between 18 and 40 years of age at low risk of pregnancy with confirmed ovulation and body mass index of 18 to 35 kg/m 2  to receive a single injection of 45, 75 or 105 mg of Depo-Provera, or a single injection of Depo-subQ provera 104 as a reference drug (15 women per group) and followed them for 7.5 months']","['Depo-Provera®', 'medroxyprogesterone acetate (MPA']","['MPA levels', 'Suppression of ovulation and pharmacokinetics', 'MPA concentrations, pharmacokinetic parameters, safety, and local tolerability', 'pharmacokinetics (PK) and pharmacodynamics (PD', 'suppressed ovulation and maintained serum MPA levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0699700', 'cui_str': 'Depo-Provera'}, {'cui': 'C1589969', 'cui_str': 'depo-subQ provera'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0699700', 'cui_str': 'Depo-Provera'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}]","[{'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0702239', 'cui_str': 'Suppression of ovulation'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",60.0,0.10597,No women in either the 105 mg group or the Depo-subQ provera 104 group ovulated within four months.,"[{'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Halpern', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Brache', 'Affiliation': 'Profamilia, Biomedical Research Department, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Bahamondes', 'Affiliation': 'Human Reproduction Unit, Department of Obstetrics and Gynaecology, School of Medicine, University of Campinas (UNICAMP) Campinas, Brazil.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Miranda', 'Affiliation': 'Instituto Chileno de Medicina Reproductiva (ICMER), Santiago, Chile.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Lendvay', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Cochón', 'Affiliation': 'Profamilia, Biomedical Research Department, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Laneta J', 'Initials': 'LJ', 'LastName': 'Dorflinger', 'Affiliation': 'FHI 360, Durham, NC, United States.'}]",Contraception: X,['10.1016/j.conx.2021.100070']
2413,34746677,Intramedullary nailing versus external fixation for open tibia fractures in Tanzania: a cost analysis.,"Objectives


Open tibia fractures pose a clinical and economic burden that is disproportionately borne by low-income countries. A randomized trial conducted by our group showed no difference in infection and nonunion comparing 2 treatments: external fixation (EF) and intramedullary nailing (IMN). Secondary outcomes favored IMN. In the absence of clear clinical superiority, we sought to compare costs between EF and IMN.
Design


Secondary cost analysis.
Setting


Single institution in Tanzania.
Patients/Participants


Adult patients with acute diaphyseal open tibia fractures who participated in a previous randomized controlled trial.
Intervention


SIGN IMN versus monoplanar EF.
Main Outcome Measurements


Direct costs of initial surgery and hospitalization and subsequent reoperation: implant, instrumentation, medications, disposable supplies, and personnel costs.Indirect costs from lost productivity of patient and caregiver.Societal (total) costs: sum of direct and indirect costs.All costs were reported in 2018 USD.
Results


Two hundred eighteen patients were included (110 IMN, 108 EF). From a payer perspective, costs were $365.83 (95% CI: $332.75-405.76) for IMN compared with $331.25 ($301.01-363.14) for EF, whereas from a societal perspective, costs were $2664.59 ($1711.22-3955.25) for IMN and $2560.81 ($1700.54-3715.09) for EF. The largest drivers of cost were reoperation and lost productivity. Accounting for uncertainty in multiple variables, probabilistic sensitivity analysis demonstrated that EF was less costly than IMN from the societal perspective in only 55% of simulations.
Conclusions


Intramedullary nail fixation compared with external fixation of open tibia fractures in a resource-constrained setting is not associated with increased cost from a societal perspective.",2021,"Accounting for uncertainty in multiple variables, probabilistic sensitivity analysis demonstrated that EF was less costly than IMN from the societal perspective in only 55% of simulations.
","['open tibia fractures in Tanzania', 'Patients/Participants\n\n\nAdult patients with acute diaphyseal open tibia fractures', 'Two hundred eighteen patients were included (110 IMN, 108 EF']","['Intramedullary nail fixation', 'external fixation (EF) and intramedullary nailing (IMN', 'external fixation', 'Intramedullary nailing versus external fixation']","['IMN', 'Societal (total) costs: sum of direct and indirect costs', 'Direct costs of initial surgery and hospitalization and subsequent reoperation: implant, instrumentation, medications, disposable supplies, and personnel costs']","[{'cui': 'C0749492', 'cui_str': 'Open fracture of tibia'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",218.0,0.125349,"Accounting for uncertainty in multiple variables, probabilistic sensitivity analysis demonstrated that EF was less costly than IMN from the societal perspective in only 55% of simulations.
","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Roberts', 'Affiliation': 'Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Claire A', 'Initials': 'CA', 'LastName': 'Donnelley', 'Affiliation': 'Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Billy T', 'Initials': 'BT', 'LastName': 'Haonga', 'Affiliation': 'Muhimbili Orthopaedic Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Kramer', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Edmund N', 'Initials': 'EN', 'LastName': 'Eliezer', 'Affiliation': 'Muhimbili Orthopaedic Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Saam', 'Initials': 'S', 'LastName': 'Morshed', 'Affiliation': 'Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shearer', 'Affiliation': 'Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA.'}]",OTA international : the open access journal of orthopaedic trauma,['10.1097/OI9.0000000000000146']
2414,34746674,Is there a correlation between functional results and radiographic findings in patients with distal radius fracture A0 type A3 treated with volar locking plate or external fixator?,"The aim of this study was to test the hypothesis that precise restoration of distal radius fractures is correlated to better patient-reported outcome.
Methods


The correlation between radiographic results and functional outcome was explored in 156 patients with extra-articular distal radius fractures included in a multicenter, randomized controlled trial comparing 2 surgical interventions, Volar Locking Plate or External Fixator. The primary functional outcome was the Patient Rated Wrist and Hand Evaluation score (PRWHE). Radiographically we assessed volar tilt, radial inclination, radial height, ulnar variance, and the presence of ulnar styloid fracture. The Pearson correlation analysis was used to estimate correlations between parameters.
Results


At 1-year follow-up the mean difference in radiographic findings compared with the uninjured side (min, max) was: reduced volar tilt 5.3° (-15°, 25°), reduced radial inclination 2.3° (-6°, 12°), radial height 1.3 mm (-4 mm, 7 mm), and ulnar variance -0.5 mm (-6 mm, 3 mm). Overall, we found no correlation between radiographic parameters and the PRWHE at 1-year follow-up within the whole group, regardless of which treatment was chosen. At the time of injury 53% (N = 80) had sustained an additional ulnar styloid fracture. After 1 year this fracture was still radiographically present in 31% (N = 43) of the patients. No correlation between PRWHE score and the presence of an ulnar styloid fracture at 1-year follow-up was found.
Conclusions


We found no correlation between functional outcome (PRWHE) and radiographic findings after 1 year in patients operated on with a Volar Locking Plate or External Fixator. Patient-specific factors were more important than radiographic measurements in this study group.Level of evidence: Therapeutic Level 2Trial registration: Norway: National Committee for Medical and Health Research Ethics 213/555ClinicalTrials.gov ID: NCT01904084Randomization of first patient: 02.09.2013.",2021,We found no correlation between functional outcome (PRWHE) and radiographic findings after 1 year in patients operated on with a Volar Locking Plate or External Fixator.,"['patients with distal radius fracture A0 type A3 treated with', '156 patients with extra-articular distal radius fractures']","['surgical interventions, Volar Locking Plate or External Fixator', 'volar locking plate or external fixator']","['additional ulnar styloid fracture', 'ulnar variance', 'distal radius fractures', 'volar tilt, radial inclination, radial height, ulnar variance, and the presence of ulnar styloid fracture', 'PRWHE score and the presence of an ulnar styloid fracture', 'Patient Rated Wrist and Hand Evaluation score (PRWHE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0079321', 'cui_str': 'External fixation device'}]","[{'cui': 'C0555336', 'cui_str': 'Fracture of ulnar styloid'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",156.0,0.0678271,We found no correlation between functional outcome (PRWHE) and radiographic findings after 1 year in patients operated on with a Volar Locking Plate or External Fixator.,"[{'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Ludvigsen', 'Affiliation': 'University of Bergen, Bergen.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Matre', 'Affiliation': 'University of Bergen, Bergen.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Vetti', 'Affiliation': 'University of Bergen, Bergen.'}, {'ForeName': 'Per Martin', 'Initials': 'PM', 'LastName': 'Kristoffersen', 'Affiliation': 'University of Bergen, Bergen.'}, {'ForeName': 'Monika Kolskår', 'Initials': 'MK', 'LastName': 'Toppe', 'Affiliation': 'Radiology Department.'}, {'ForeName': 'Rakel', 'Initials': 'R', 'LastName': 'Gudmundsdottir', 'Affiliation': 'Orthopaedic Department, Haukeland University Hospital.'}, {'ForeName': 'Yngvar', 'Initials': 'Y', 'LastName': 'Krukhaug', 'Affiliation': 'University of Bergen, Bergen.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dybvik', 'Affiliation': 'Norwegian National Advisory Unit on Arthroplasty and Hip Fractures, Bergen, Norway.'}, {'ForeName': 'Jonas Meling', 'Initials': 'JM', 'LastName': 'Fevang', 'Affiliation': 'University of Bergen, Bergen.'}]",OTA international : the open access journal of orthopaedic trauma,['10.1097/OI9.0000000000000142']
2415,34746664,Virtual reality-based physical therapy for patients with lower extremity injuries: feasibility and acceptability.,"Introduction


Traditional physical therapy (PT) requires patients to attend weekly in-office supervised physical therapy appointments. However, between 50% and 70% of patients who would benefit do not receive prescribed PT due to barriers to access. Virtual Reality (VR) provides a platform for remote delivery of PT to address these access barriers.
Methods


We developed a VR-PT program consisting of training, games, and a progress dashboard for 3 common lower extremity physical therapy exercises. We enrolled orthopaedic trauma patients with lower extremity injuries. Patients completed a VR-PT session, consisting of training and one of the exercise-based games. Pre- and post-VR-PT questionnaires were completed.
Results


We enrolled 15 patients with an average age of 51 years. Fourteen patients said they would enroll in a randomized trial in which they had a 50% chance of receiving VR-PT vs receiving standard of care. When asked to rate their experience using the VR-PT module on a scale from 0-10-with 0 being anchored as ""I hated it"" and 10 being anchored as ""I loved it""-the average rating was 7.5. Patients rated the acceptability of VR-PT as a 3.9 out of 5, the feasibility as a 4.0 out of 5, and the usability as a 67.5 out of 100.
Conclusion


The response to VR-PT in this pilot study was positive overall. A VR-based PT program may add value for both patients and clinicians in terms of objective data collection (to aid in compliance monitoring, progression toward goals and exercise safety), increased engagement and increased access.",2021,"Patients rated the acceptability of VR-PT as a 3.9 out of 5, the feasibility as a 4.0 out of 5, and the usability as a 67.5 out of 100.
","['patients with lower extremity injuries', 'Fourteen patients said they would enroll in a randomized trial in which they had a 50% chance of receiving VR-PT vs receiving standard of care', 'enrolled orthopaedic trauma patients with lower extremity injuries', '15 patients with an average age of 51\u200ayears']","['Virtual reality-based physical therapy', 'Introduction\n\n\nTraditional physical therapy (PT', 'VR-based PT program', 'Virtual Reality (VR', 'VR-PT session, consisting of training and one of the exercise-based games']",['acceptability of VR-PT'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0080151', 'cui_str': 'Simian AIDS'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]",15.0,0.0190866,"Patients rated the acceptability of VR-PT as a 3.9 out of 5, the feasibility as a 4.0 out of 5, and the usability as a 67.5 out of 100.
","[{'ForeName': 'Clifford A', 'Initials': 'CA', 'LastName': 'Reilly', 'Affiliation': 'Department of Orthopaedics, Dartmouth-Hitchcock Medical Center, Lebanon, NH.'}, {'ForeName': 'Aimee Burnett', 'Initials': 'AB', 'LastName': 'Greeley', 'Affiliation': 'Department of Orthopaedics, Dartmouth-Hitchcock Medical Center, Lebanon, NH.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Jevsevar', 'Affiliation': 'Department of Orthopaedics, Dartmouth-Hitchcock Medical Center, Lebanon, NH.'}, {'ForeName': 'Ida Leah', 'Initials': 'IL', 'LastName': 'Gitajn', 'Affiliation': 'Department of Orthopaedics, Dartmouth-Hitchcock Medical Center, Lebanon, NH.'}]",OTA international : the open access journal of orthopaedic trauma,['10.1097/OI9.0000000000000132']
2416,34747022,Does maternal inhibitory control mediate effects of a parenting intervention on maternal sensitive discipline? Evidence from a randomized-controlled trial.,"The quality of parenting greatly impacts child development, highlighting the importance of support programs that effectively improve parenting. Studies on successful intervention programs define their efficacy by gains in parenting and/or child development. However, much remains unknown about the internal processes that explain how parenting interventions bring about their effects. The aims of the current randomized-controlled study were to test whether the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) improved maternal inhibitory control (1) and whether inhibitory control mediated any effects of VIPP-SD on maternal sensitive discipline (2). In total, 66 mothers of whom a random 33% received the VIPP-SD and the others a ""dummy"" intervention participated in pre- and post-intervention assessments. Sensitive discipline was observed during a semi-structured limit-setting situation and inhibitory control was measured using a stop-signal task. Contrary to expectations, inhibitory control improved over time in the control group and sensitive discipline did not show the expected increase in the intervention group. Results did not support mediation. We suggest that the intervention may have induced cognitive restructuring of parenting schemas, delaying improvements in post-intervention inhibitory control and sensitive discipline. Factors that may be involved in parents' susceptibility to interventions require attention in future work.",2021,"Contrary to expectations, inhibitory control improved over time in the control group and sensitive discipline did not show the expected increase in the intervention group.",['66 mothers of whom a random 33% received the'],"['parenting intervention', 'Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD', 'VIPP-SD']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",[],66.0,0.0177297,"Contrary to expectations, inhibitory control improved over time in the control group and sensitive discipline did not show the expected increase in the intervention group.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kolijn', 'Affiliation': 'Department of Clinical Child and Family Studies, and Amsterdam Public Health, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Bianca G', 'Initials': 'BG', 'LastName': 'van den Bulk', 'Affiliation': 'Erasmus University Rotterdam, PA, Rotterdam, The Netherlands.'}, {'ForeName': 'Marinus H', 'Initials': 'MH', 'LastName': 'van IJzendoorn', 'Affiliation': 'Leiden Consortium on Individual Development, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Marian J', 'Initials': 'MJ', 'LastName': 'Bakermans-Kranenburg', 'Affiliation': 'Department of Clinical Child and Family Studies, and Amsterdam Public Health, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rens', 'Initials': 'R', 'LastName': 'Huffmeijer', 'Affiliation': 'Leiden Consortium on Individual Development, Leiden University, Leiden, The Netherlands.'}]",Infant mental health journal,['10.1002/imhj.21946']
2417,34746999,An investigation into the Effects of Intravenous Vitamin C on Pulmonary CT Findings and Clinical Outcomes of Patients with COVID 19 Pneumonia A Randomized Clinical Trial.,"PURPOSE


In late December 2019, a series of unexplained cases of pneumonia were reported in Wuhan, China. On January 12, 2020, the World Health Organization temporarily named the virus responsible for the emerging cases of pneumonia as the 2019 coronavirus. Acute respiratory distress syndrome (ARDS) due to Covid-19 has rapidly spread around the world, and while no specific treatment or vaccine has been reported, mortality rates remain high. One of the suggested treatments for cellular damage in the pathogenesis of ARDS caused by the coronavirus is the administration of high doses of intravenous vitamin C. Considering the paucity of literature on the therapeutic effects of high doses of intravenous vitamin C in patients with ARDS resulting from the coronavirus, this study was conducted to assess this therapeutic supplement in these patients.
MATERIALS AND METHODS


This study was performed as a single-center clinical trial in patients with a documented diagnosis of COVID-19 pneumonia. 54 eligible patients with moderate to severe COVID-19 symptoms, based on specific inclusion and exclusion criteria, were included in the investigation and randomly divided into two groups. The control group consisted of 26 patients who received standard treatment, whereas the treatment group was comprised of 18 patients administered intravenous vitamin C at a dose of 2 g every 6 hours for 5 days in addition to standard treatment. Demographic characteristics, underlying diseases, length of hospital stay, and mortality rates were reviewed and collected. Oxygen saturation, respiratory rates, serum C Reactive Protein (CRP) levels, lymphopenia and lung parenchymal involvement on CT were investigated at the time of admission and on the sixth day after hospitalization. Finally, all variables were analyzed with IBM SPSS Statistics 23 software and a significant statistical difference was defined for all variables, P <0.05.
RESULTS


Of these variables, the amount of oxygen saturation in the vitamin C group increased significantly from 86±5% on the first day of hospitalization to 90±3% on the sixth day of hospitalization (P value=0.02). Also, the respiratory rate in the vitamin C group decreased significantly from 27±3 on the first day of hospitalization to 24±3 on the sixth day of hospitalization (P value=0.03). Lung CT scans of patients in the two groups reported by two radiologists were also compared. Based on the report of the radiologists, the rate of lung involvement in the vitamin C group was significantly lower than in the control group at the end of treatment (P value=0.02).
CONCLUSION


Due to the effectiveness of high doses of intravenous vitamin C on reducing lung involvement and improving clinical symptoms, further studies with a larger sample size are recommended to demonstrate the effects of this drug supplement.",2021,the amount of oxygen saturation in the vitamin C group increased significantly from 86±5% on the first day of hospitalization to 90±3% on the sixth day of hospitalization (P value=0.02).,"['patients with a documented diagnosis of COVID-19 pneumonia', 'Patients with COVID 19 Pneumonia', '54 eligible patients with moderate to severe COVID-19 symptoms, based on specific inclusion and exclusion criteria', 'Acute respiratory distress syndrome (ARDS', 'patients with ARDS']","['Intravenous Vitamin C', 'intravenous vitamin C', 'vitamin C']","['lung involvement and improving clinical symptoms', 'respiratory rate', 'Oxygen saturation, respiratory rates, serum C Reactive Protein (CRP) levels, lymphopenia and lung parenchymal involvement on CT', 'rate of lung involvement', 'Demographic characteristics, underlying diseases, length of hospital stay, and mortality rates', 'oxygen saturation', 'Lung CT scans']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0412611', 'cui_str': 'CT of lungs'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",54.0,0.0649149,the amount of oxygen saturation in the vitamin C group increased significantly from 86±5% on the first day of hospitalization to 90±3% on the sixth day of hospitalization (P value=0.02).,"[{'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Tehrani', 'Affiliation': 'Labbafinejad Clinical Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Tehrani.shabnam89@yahoo.com.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Yadegarynia', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. d.yadegarynia@gmail.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Abrishami', 'Affiliation': 'Assistant Professor of Radiology, Department of Radiology, Shahid Labbafinejad hospital,Shahid Beheshti University of Medical Sciences,Tehran,Iran. abr.alireza@yahoo.com.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Moradi', 'Affiliation': 'Labbafinejad Clinical Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. hamidehmoradi05@gmail.com.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Gharaei', 'Affiliation': 'Anesthesiology department, school of medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. babakgaraei@gmail.com.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Rauofi', 'Affiliation': 'Department of radiology, school of medicine, Imam Hossein hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. masomeraoufi@gmail.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Maghsoudi Nejad', 'Affiliation': 'School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. F.maghsoudi92@gmail.com.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Sali', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Dr.sali@gmail.com.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Khabiri', 'Affiliation': 'Labbafinejad Clinical Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. dr.neda_khabiri@yahoo.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Abolghasemi', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. saraabolghsemi1@gmail.com.'}]",Urology journal,['10.22037/uj.v18i.6863']
2418,34746997,"The effect of Melatonin on Improving the benign Prostatic Hyperplasia Urinary Symptoms, a Randomized Clinical Trial.","PURPOSE


to investigate the effect of melatonin along with tamsulosin in the improving the BPH urinary symptoms.
MATERIALS AND METHODS


A total of 108 men with BPH symptoms, age of ≥50 years, and International Prostate Symptom Score (IPSS) ≥8 entered into the parallel group randomized, double-blind clinical trial with balanced randomization. Treatment group received of 3mg melatonin plus 0.4mg tamsulosin and control group received placebo plus 0.4mg tamsulosin. Patients and physicians were concealed by sealed and opaque envelopes. Symptoms were assessed at baseline and 1 month after treatment. Finally all scores at the initial and end of the study compared and analyzed using SPSS software.
RESULTS


This study showed that adding melatonin to classic treatment of BPH patients with tamsulosin could significantly reduce the likelihood of nocturia by 2.39 times (95% CI: 1.07-5.32, OR = 2.39, p = 0.033) and could also reduce the frequency of urination by 2.59 times (95% CI: 1.15-5.84, OR = 2.59, p = 0.021). There was no statistically significant difference between the two groups in IPSS, intermittency, incomplete emptying, straining, urgency, and weak stream.
CONCLUSION


Melatonin plus tamsulosin treatment is associated with a significant improvement of nocturia and frequency in patients with benign proststic hyperplasia. However, it is necessary to do more studies.",2021,"There was no statistically significant difference between the two groups in IPSS, intermittency, incomplete emptying, straining, urgency, and weak stream.
","['108 men with BPH symptoms, age of ≥50 years, and International Prostate Symptom Score (IPSS', 'patients with benign proststic hyperplasia', 'BPH patients with']","['placebo plus 0.4mg tamsulosin', 'tamsulosin', 'melatonin plus 0.4mg tamsulosin', 'Melatonin', 'melatonin', 'Melatonin plus tamsulosin']","['IPSS, intermittency, incomplete emptying, straining, urgency, and weak stream', 'frequency of urination', 'likelihood of nocturia', 'nocturia and frequency']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0232854', 'cui_str': 'Slowing of urinary stream'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",108.0,0.371825,"There was no statistically significant difference between the two groups in IPSS, intermittency, incomplete emptying, straining, urgency, and weak stream.
","[{'ForeName': 'Amirreza', 'Initials': 'A', 'LastName': 'Fotovat', 'Affiliation': 'Uro-Oncology Research Center, Tehran University of Medical Sciences, Tehran, Iran. fotovat_a@yahoo.com.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Samadzadeh', 'Affiliation': 'Department of Urology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran. samadzadehb@gmail.com.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Ayati', 'Affiliation': 'Uro-Oncology Research Center, Tehran University of Medical Sciences, Tehran, Iran. drayati_mohsen@yahoo.com.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Nowroozi', 'Affiliation': 'Uro-Oncology Research Center, Tehran University of Medical Sciences, Tehran, Iran. mrnowroozi@yahoo.com.'}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Momeni', 'Affiliation': 'Uro-Oncology Research Center, Tehran University of Medical Sciences, Tehran, Iran. seyedali6127@yahoo.com.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Yavari', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. syavari@yahoo.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Nasseri', 'Affiliation': 'Department of Radiology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. a_nasseri@gmail.com.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Sharifi', 'Affiliation': 'Uro-Oncology Research Center, Tehran University of Medical Sciences, Tehran, Iran. lalehsharifi@yahoo.com.'}]",Urology journal,['10.22037/uj.v18i.6761']
2419,34746976,The acceptability of a therapist-assisted internet-delivered cognitive behaviour therapy program for the treatment of anxiety disorders in adolescents: a qualitative study.,"Computerized treatments have been shown to be effective in young people with anxiety disorders. However, there has been limited investigation into the experiences of adolescents in undertaking this treatment. This qualitative study explored adolescents' experiences of being treated for an anxiety disorder, using an online intervention with therapist support, as part of a randomised controlled trial. Individual semi-structured interviews were conducted with thirteen adolescents aged between 13 and 17 years, who had received the online intervention. Data were analysed using reflexive thematic analysis. Two cross-cutting themes were identified: (i) Usability of the program, and (ii) Putting techniques into practice. Although the convenience of online sessions was recognised as positive, many of the adolescents expressed a preference for face-to-face sessions. The length of sessions and the large amount of reading involved was highlighted by most participants. The transdiagnostic nature of the content meant some elements of the programme were seen as less relevant. While many participants appreciated the 'fun' aspect of the program, others felt that certain aspects of the program were not suitable for their age group. Exposure, psychoeducation and cognitive restructuring were generally received positively, whereas responses to the use of relaxation and rewards were much more mixed. Our findings highlight the potential utility for online treatments delivered with therapist support. However, they also highlight how issues with both the format and treatment components can impact the acceptability of a program. As such, further work is warranted to improve the acceptability of online treatments for adolescents with anxiety disorders.",2021,"Individual semi-structured interviews were conducted with thirteen adolescents aged between 13 and 17 years, who had received the online intervention.","[""adolescents' experiences of being treated for an anxiety disorder"", 'thirteen adolescents aged between 13 and 17\xa0years, who had received the online intervention', 'adolescents with anxiety disorders', 'young people with anxiety disorders', 'anxiety disorders in adolescents']",['therapist-assisted internet-delivered cognitive behaviour therapy program'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],13.0,0.0147608,"Individual semi-structured interviews were conducted with thirteen adolescents aged between 13 and 17 years, who had received the online intervention.","[{'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Smart', 'Affiliation': 'School of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University and University of Warwick, Coventry, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Harvey', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Waite', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK. p.l.waite@reading.ac.uk.'}]",European child & adolescent psychiatry,['10.1007/s00787-021-01903-6']
2420,34746964,Inter-method reliability of the modified Rankin Scale in patients with subarachnoid hemorrhage.,"BACKGROUND AND OBJECTIVES


The modified Rankin Scale (mRS) is one of the most frequently used outcome measures in trials in patients with an aneurysmal subarachnoid hemorrhage (aSAH). The assessment method of the mRS is often not clearly described in trials, while the method used might influence the mRS score. The aim of this study is to evaluate the inter-method reliability of different assessment methods of the mRS.
METHODS


This is a prospective, randomized, multicenter study with follow-up at 6 weeks and 6 months. Patients aged ≥ 18 years with aSAH were randomized to either a structured interview or a self-assessment of the mRS. Patients were seen by a physician who assigned an mRS score, followed by either the structured interview or the self-assessment. Inter-method reliability was assessed with the quadratic weighted kappa score and percentage of agreement. Assessment of feasibility of the self-assessment was done by a feasibility questionnaire.
RESULTS


The quadratic weighted kappa was 0.60 between the assessment of the physician and structured interview and 0.56 between assessment of the physician and self-assessment. Percentage agreement was, respectively, 50.8 and 19.6%. The assessment of the mRS through a structured interview and by self-assessment resulted in systematically higher mRS scores than the mRS scored by the physician. Self-assessment of the mRS was proven feasible.
DISCUSSION


The mRS scores obtained with different assessment methods differ significantly. The agreement between the scores is low, although the reliability between the assessment methods is good. This should be considered when using the mRS in clinical trials.
TRIAL REGISTRATION


www.trialregister.nl ; Unique identifier: NL7859.",2021,The assessment of the mRS through a structured interview and by self-assessment resulted in systematically higher mRS scores than the mRS scored by the physician.,"['patients with subarachnoid hemorrhage', 'patients with an aneurysmal subarachnoid hemorrhage (aSAH', 'Patients aged\u2009≥', '18\xa0years with aSAH']",['structured interview or a self-assessment of the mRS'],"['quadratic weighted kappa', 'modified Rankin Scale (mRS', 'mRS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.017997,The assessment of the mRS through a structured interview and by self-assessment resulted in systematically higher mRS scores than the mRS scored by the physician.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nobels-Janssen', 'Affiliation': 'Department of Neurology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands. edith.nobels-janssen@radboudumc.nl.'}, {'ForeName': 'E N', 'Initials': 'EN', 'LastName': 'Postma', 'Affiliation': 'Amsterdam UMC, Department of Neurosurgery, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'I L', 'Initials': 'IL', 'LastName': 'Abma', 'Affiliation': 'IQ Healthcare, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'J M C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurosurgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Haeren', 'Affiliation': 'Department of Neurosurgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Schenck', 'Affiliation': 'Department of Neurosurgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Moojen', 'Affiliation': 'Department of Neurosurgery, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'den Hertog', 'Affiliation': 'Department of Neurology, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nanda', 'Affiliation': 'Department of Neurosurgery, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'A R E', 'Initials': 'ARE', 'LastName': 'Potgieser', 'Affiliation': 'Department of Neurosurgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Coert', 'Affiliation': 'Amsterdam UMC, Department of Neurosurgery, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'W I M', 'Initials': 'WIM', 'LastName': 'Verhagen', 'Affiliation': 'Department of Neurology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'R H M A', 'Initials': 'RHMA', 'LastName': 'Bartels', 'Affiliation': 'Department of Neurosurgery, Radboud University Medical Center, PO Box 9101, Nijmegen, 6500 HB, The Netherlands.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'van der Wees', 'Affiliation': 'IQ Healthcare, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Verbaan', 'Affiliation': 'Amsterdam UMC, Department of Neurosurgery, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Boogaarts', 'Affiliation': 'Department of Neurosurgery, Radboud University Medical Center, PO Box 9101, Nijmegen, 6500 HB, The Netherlands.'}]",Journal of neurology,['10.1007/s00415-021-10880-4']
2421,34748450,"Acute impact of Nordic hamstring exercise on sprint performance after 24, 48 and 72 hours.","The Nordic Hamstring Exercise (NHE) improves the strength of the hamstring muscles, as well as prevents and rehabilitates the injuries of said muscles. However, the eccentric demand of NHE may influence the athlete's performance, making compliance with these programmes difficult. The aim is to analyse the acute impact on sprint performance after the passing of 24, 48, and 72 hours respectively since an NHE-based session (4 sets of 10 repetitions) had taken place. Participants were randomly divided into an experimental group (EG) (n = 12 male participants) who carried out an NHE session and a measurement of their 30 m sprint performance in each of the three subsequent days, and a control group (CG) (n = 12 male participants) who did not take part in the NHE session. The results show a significant reduction of maximum power within 24 hours ( t  = 3.57,  d  = 0.22,  P  < .0273) as well of the production of high speed horizontal force up to after 48 hours ( t  = 4.82,  d  = 0.22,  P  < .0001) in the EG. These results may suggest separating weekly NHE sessions from competition or demanding training in which sprint performance should not be affected by at least 72 hours.",2021,"The results show a significant reduction of maximum power within 24 hours ( t  = 3.57,  d  = 0.22,  P  < .0273) as well of the production of high speed horizontal force up to after 48 hours ( t  = 4.82,  d  = 0.22,  P  < .0001) in the EG.",[],"['Nordic hamstring exercise', 'Nordic Hamstring Exercise (NHE', 'control group (CG) (n\xa0=\xa012 male participants) who did not take part in the NHE session']","['strength of the hamstring muscles', 'maximum power', 'production of high speed horizontal force', 'sprint performance']",[],"[{'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",12.0,0.0468923,"The results show a significant reduction of maximum power within 24 hours ( t  = 3.57,  d  = 0.22,  P  < .0273) as well of the production of high speed horizontal force up to after 48 hours ( t  = 4.82,  d  = 0.22,  P  < .0001) in the EG.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Alonso-Fernandez', 'Affiliation': 'Department of Special Didactics, Faculty of Science Education and Sport, University of Vigo, Pontevedra, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lopez-Barreiro', 'Affiliation': 'Faculty of Science Education and Sport, University of Vigo, Pontevedra, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Garganta', 'Affiliation': 'Department of Kinanthropometry, Faculty of Sport, University of Porto, Porto, Portugal.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Taboada-Iglesias', 'Affiliation': 'Department of Special Didactics, Faculty of Science Education and Sport, University of Vigo, Pontevedra, Spain.'}]",Sports biomechanics,['10.1080/14763141.2021.1992493']
2422,34748876,VeggieSense: A non-taste multisensory exposure technique for increasing vegetable acceptance in young children.,"Vegetable consumption falls well below recommended levels for children in the UK. Previous research has found that repeated non-taste sensory exposure over the course of several days increases young children's willingness to touch and taste vegetables. The current study examined the impact of a one-off multisensory non-taste exposure intervention that took place on a single day on children's willingness to taste and intake of the exposed vegetables. Children (N = 110) aged 3- to 4-years-old were assigned to one of three intervention groups or to a control group. Children in all groups participated individually in a single activity session delivered in their nursery. Children in the intervention conditions took part in fun activities that provided either (a) visual exposure, (b) smell and visual exposure, or (c) smell, touch and visual exposure to six raw and prepared vegetables. Children in the control group engaged in a visual exposure activity with non-food items. After the exposure activities, all children were offered the prepared vegetables to eat; their willingness to taste and intake of the vegetables were measured. Results confirmed previous findings of sensory exposure activities increasing children's willingness to taste and intake of vegetables and revealed linear trends in both measures of acceptance with the number of senses engaged; children who took part in smell, touch and visual activities showed the highest level of acceptance. Findings suggest that multisensory exposures are effective in increasing consumption of vegetables in young children and that the effect of sensory exposure to healthy foods may be cumulative, with the more senses engaged prior to offering a food, the better.",2021,"Results confirmed previous findings of sensory exposure activities increasing children's willingness to taste and intake of vegetables and revealed linear trends in both measures of acceptance with the number of senses engaged; children who took part in smell, touch and visual activities showed the highest level of acceptance.","['Children (N\u202f=\u202f110) aged 3- to 4-years-old', 'VeggieSense', 'young children', ""children's willingness to taste and intake of the exposed vegetables""]","['visual exposure, (b) smell and visual exposure, or (c) smell, touch and visual exposure to six raw and prepared vegetables']","['vegetable acceptance', 'visual exposure activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",110.0,0.0284562,"Results confirmed previous findings of sensory exposure activities increasing children's willingness to taste and intake of vegetables and revealed linear trends in both measures of acceptance with the number of senses engaged; children who took part in smell, touch and visual activities showed the highest level of acceptance.","[{'ForeName': 'Alan Parry', 'Initials': 'AP', 'LastName': 'Roberts', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley, Reading, RG6 6BZ, UK. Electronic address: a.p.roberts@reading.ac.uk.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Cross', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley, Reading, RG6 6BZ, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hale', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley, Reading, RG6 6BZ, UK.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Houston-Price', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley, Reading, RG6 6BZ, UK.'}]",Appetite,['10.1016/j.appet.2021.105784']
2423,34748774,Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients with Crohn's Disease.,"BACKGROUND


Mirikizumab is a humanized monoclonal antibody targeting IL-23p19 with demonstrated efficacy in psoriasis and ulcerative colitis. We investigated the safety and efficacy of mirikizumab in patients with moderate-to-severe Crohn's disease (CD).
METHODS


Patients (N=191) were randomized (2:1:1:2) to receive placebo (PBO), 200, 600, or 1000mg mirikizumab, administered intravenously (IV) every 4 weeks (Q4W). Patients who received mirikizumab and achieved ≥1 point improvement in SES-CD at Week 12 (Re-randomized Maintenance Cohort) were re-randomized to continue their induction IV treatment (IV-C) or receive 300mg mirikizumab subcutaneously (SC) Q4W. Non-randomized Maintenance Cohort included endoscopic non-improvers (NI/1000mg) and PBO patients (PBO/1000mg) who received 1000mg mirikizumab IV from Week 12. The primary objective was to evaluate superiority of mirikizumab to PBO in inducing endoscopic response (50% reduction from baseline in SES-CD) at Week 12.
RESULTS


At Week 12, endoscopic response was significantly higher by the pre-defined 2-sided significance level of 0.1 for all mirikizumab groups compared to PBO (200mg: 25.8%, 8/31[95%CI: 10.4-41.2], p=0.079; 600mg: 37.5%, 12/32[95%CI: 20.7-54.3], p=0.003; 1000mg: 43.8%, 28/64[95%CI: 31.6-55.9], p<0.001; PBO: 10.9 %, 7/64[95%CI: 3.3-18.6]). Endoscopic response at Week 52 was 58.5%(24/41) and 58.7%(27/46) in the IV-C and SC groups, respectively. Frequencies of adverse events (AE) in mirikizumab groups were similar to PBO. Through Week 52, frequencies of TEAEs were similar across all groups. Frequencies of serious AE and discontinuations due to AE were higher in the Non-randomized Maintenance Cohort.
CONCLUSION


Mirikizumab effectively induced endoscopic response after 12 weeks in patients with moderate-to-severe CD and demonstrated durable efficacy to Week 52.",2021,"Endoscopic response at Week 52 was 58.5%(24/41) and 58.7%(27/46) in the IV-C and SC groups, respectively.","['Patients (N=191', ""Patients with Crohn's Disease"", ""patients with moderate-to-severe Crohn's disease (CD""]","['PBO', 'Mirikizumab', 'mirikizumab', 'placebo (PBO', 'mirikizumab subcutaneously (SC) Q4W. Non-randomized Maintenance Cohort included endoscopic non-improvers (NI/1000mg) and PBO patients (PBO/1000mg) who received 1000mg mirikizumab IV']","['SES-CD', 'Efficacy and Safety', 'Endoscopic response', 'safety and efficacy', 'Frequencies of adverse events (AE', 'endoscopic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.133473,"Endoscopic response at Week 52 was 58.5%(24/41) and 58.7%(27/46) in the IV-C and SC groups, respectively.","[{'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: bruce.sands@mssm.edu.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'University Hospital of Nancy, Vandoeuvre-les-Nancy, Fance.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Kierkus', 'Affiliation': ""Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Peter D R', 'Initials': 'PDR', 'LastName': 'Higgins', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Western University, London, Canada.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Hirai', 'Affiliation': 'Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': ""D'Haens"", 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Belin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Gomez-Valderas', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'April N', 'Initials': 'AN', 'LastName': 'Naegeli', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Tuttle', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Pollack', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University California San Diego, La Jolla, CA, USA.'}]",Gastroenterology,['10.1053/j.gastro.2021.10.050']
2424,34748738,Patterns and Determinants of the Double Burden of Malnutrition among Adolescents: A 14-Year Follow-up of a Birth Cohort in Rural China.,"OBJECTIVE


To examine the prevalence of the double burden of malnutrition and its associated factors among adolescents in rural China.
STUDY DESIGN


A birth cohort of adolescents born to women in northwestern China who participated in a double-blind, randomized, controlled trial of micronutrient supplementation during pregnancy from August 2002 to January 2006 was enrolled. Follow-up was conducted from June to December 2016.
RESULTS


A total of 2115 participants were analyzed (median age 12 years; IQR±1), the majority of whom were male (59.7%). The nutritional status distribution was 17.72% underweight, 8.62% overweight, 0.96% obese, and 2.58% stunted. Girls were less likely to be overweight/obese (RRR=0.67, 95% CI= 0.48-0.92) but more likely to be underweight (RRR=1.65, 95% CI=1.25-2.17) or stunted (RRR=2.26, 95% CI=1.21-4.22). Children of underweight mothers (RRR=1.63, 95% CI= 1.19-2.25) with a history of small-for-gestational-age (SGA) (RRR=1.64, 95% CI= 1.14-2.36) or described as being a ""picky eater"" (RRR=1.53, 95% CI= 1.18-1.99) had a higher risk of being underweight. Children whose fathers' education was primary or below (RRR=2.25, 95% CI= 1.11-4.59), with maternal height <150.1 cm (RRR=2.46, 95% CI= 1.12-5.39), or who had underweight mothers (RRR=2.80, 95% CI= 1.37-5.72) had a higher likelihood of stunting. Overweight/obesity was associated with high and middle household wealth (RRR=1.62, 95% CI= 1.14-2.32), overweight mothers (RRR=1.86, 95% CI= 1.25-2.78), and picky eating (RRR=0.62, 95% CI= 0.46-0.84).
CONCLUSIONS


Malnutrition (undernutrition and overweight/obesity) is common in rural Chinese adolescents and is associated with perinatal, genetic and economic conditions.",2021,"Overweight/obesity was associated with high and middle household wealth (RRR=1.62, 95%","['adolescents in rural China', 'A 14-Year Follow-up of a Birth Cohort in Rural China', 'A birth cohort of adolescents born to women in northwestern China who participated in a double-blind', 'rural Chinese adolescents', 'during pregnancy from August 2002 to January 2006 was enrolled', 'Adolescents', 'A total of 2115 participants were analyzed (median age 12 years; IQR±1), the majority of whom were male (59.7']",['micronutrient supplementation'],"['Overweight/obesity', 'nutritional status distribution', 'picky eating']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",2115.0,0.577463,"Overweight/obesity was associated with high and middle household wealth (RRR=1.62, 95%","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elhoumed', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, P.R. China;; National Institute of Public Health Research (INRSP), BP. 695, Nouakchott, Mauritania.""}, {'ForeName': 'Amanuel Kidane', 'Initials': 'AK', 'LastName': 'Andegiorgish', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, P.R. China;; Department of Epidemiology and Biostatistics, Asmara College of Health Sciences, School of Public Health, P.O.Box 8566, Asmara, Eritrea.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Qi', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, P.R. China.""}, {'ForeName': 'Mitslal Abrha', 'Initials': 'MA', 'LastName': 'Gebremedhin', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, P.R. China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, P.R. China.""}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Uwimana', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, P.R. China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Nutrition and Food Safety Research, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, P.R. China.""}, {'ForeName': 'Zhonghai', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, P.R. China.""}, {'ForeName': 'Lingxia', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, P.R. China;; Key Laboratory of Environment and Genes Related to Diseases, Xi'an Jiaotong University, Ministry of Education, Xi'an, Shaanxi, P.R. China. Electronic address: tjzlx@mail.xjtu.edu.cn.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2021.10.062']
2425,34749015,"Author's response to Z. Huang on his commentary on ""Effect of a perioperative immune-enhancing diet in clean-contaminated head and neck cancer surgery: A randomized controlled trial"" (Int. J. Surg. 94 (2021) 106114).",,2021,,"['94', 'clean-contaminated head and neck cancer surgery']",['perioperative immune-enhancing diet'],[],"[{'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",[],,0.0901644,,"[{'ForeName': 'Pichit', 'Initials': 'P', 'LastName': 'Sittitrai', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. Electronic address: psittitrai@yahoo.com.'}, {'ForeName': 'Donyarat', 'Initials': 'D', 'LastName': 'Ruenmarkkaew', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. Electronic address: rdonyarat@gmail.com.'}, {'ForeName': 'Somkamol', 'Initials': 'S', 'LastName': 'Booyaprapa', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Boonsita', 'Initials': 'B', 'LastName': 'Kasempitakpong', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106175']
2426,34749008,Health care coach support to assist with advance care planning and symptom management -A randomized controlled trial.,"Advance care planning and symptom management (supportive cancer care) improves patient experiences and reduces acute care use (hospitalizations and emergency department visits). Strong evidence supports team-based approaches to deliver supportive cancer care. However no studies, to our knowledge, have evaluated the use of lay or community health workers to deliver supportive cancer care as compared to usual cancer care. The ""Health Care Coach Support"" intervention was developed to improve cancer care. The intervention assigns a lay or community health worker ""health coach"" to all patients newly diagnosed with advanced stages of cancer or patients with recurrent or progressive disease. The intervention aims to educate and activate patients in advance care planning discussions and symptom management with their clinicians. Patients are randomized in a 1:1 allocation to either the 12-month health coach intervention combined with usual oncology care or usual oncology care alone. The primary outcome is to evaluate whether the intervention reduces acute care use measured at 6-months follow-up more than usual care. Secondary outcomes include the effect on acute care, palliative care, and hospice at 12-months follow-up and one month prior to death for patients who die. Additional secondary outcomes include changes in patient satisfaction with decision and patient satisfaction with care from baseline (time of enrollment) to 3-, 6-, 9- and 12-months post-enrollment. The Health Coach Support study addresses an important gap in supportive cancer care by testing whether a team-based approach using non-professional personnel can ensure delivery of these services. Findings can assist in our understanding of how to improve care for patients with cancer. ClinicalTrials.gov Registration #NCT03154190.",2021,Advance care planning and symptom management (supportive cancer care) improves patient experiences and reduces acute care use (hospitalizations and emergency department visits).,['patients with cancer'],"['health coach intervention combined with usual oncology care or usual oncology care alone', 'intervention assigns a lay or community health worker ""health coach', 'Advance care planning and symptom management (supportive cancer care']","['patient satisfaction with decision and patient satisfaction with care from baseline (time of enrollment) to', 'acute care use measured at 6-months follow-up more than usual care', 'effect on acute care, palliative care, and hospice at 12-months follow-up and one month prior to death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0868411,Advance care planning and symptom management (supportive cancer care) improves patient experiences and reduces acute care use (hospitalizations and emergency department visits).,"[{'ForeName': 'Manali I', 'Initials': 'MI', 'LastName': 'Patel', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States of America; Medical Services, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, United States of America; Center for Primary Care and Outcomes Research/Health Research and Policy, Stanford University School of Medicine, Stanford, CA, United States of America. Electronic address: manalip@stanford.edu.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Aguilar', 'Affiliation': 'Providence Medical Foundation, Fullerton, CA, United States of America.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Sanchez', 'Affiliation': 'Providence Medical Foundation, Fullerton, CA, United States of America.'}, {'ForeName': 'Etsegenet', 'Initials': 'E', 'LastName': 'Sisay', 'Affiliation': 'Providence Medical Foundation, Fullerton, CA, United States of America.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'St Jude Crosson Cancer Institute, Center for Hematology and Oncology, Fullerton, CA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106617']
2427,34748929,Left Atrial Appendage Closure versus Non-Warfarin Oral Anticoagulation in Atrial Fibrillation: 4-Year Outcomes of PRAGUE-17.,"BACKGROUND


The PRAGUE-17 trial demonstrated that left atrial appendage closure (LAAC) was non-inferior to non-warfarin oral anticoagulants (NOAC) for preventing major neurological, cardiovascular or bleeding events in high-risk patients with atrial fibrillation (AF).
OBJECTIVE


To assess the pre-specified long-term (4-year) outcomes in PRAGUE-17.
METHODS


PRAGUE-17 was a randomized non-inferiority trial comparing percutaneous LAAC (Watchman or Amulet) with NOACs (95% apixaban) in non-valvular AF patients with a history of cardioembolism, clinically-relevant bleeding, or both CHA 2 DS 2 -VASc > 3 and HASBLED > 2. The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically-relevant bleeding, or procedure/device-related complications (LAAC group only). The primary analysis was modified intention-to-treat (mITT).
RESULTS


We randomized 402 AF patients (201 per group, age 73.3±7.0 years, 65.7% male, CHA 2 DS 2 -VASc 4.7+1.5, HASBLED 3.1+0.9). After 3.5 years median follow-up (1,354 patients-years), LAAC was non-inferior to NOAC for the primary endpoint by mITT (subdistribution hazard ratio[sHR] 0.81, 95% CI 0.56-1.18; p=0.27; p for non-inferiority=0.006). For the components of the composite endpoint, the corresponding sHRs (and 95% CIs) were 0.68 (0.39-1.20; p=0.19) for cardiovascular death, 1.14 (0.56-2.30; p=0.72) for all-stroke/TIA, 0.75 (0.44-1.27; p=0.28) for clinically-relevant bleeding, and 0.55 (0.31-0.97; p=0.039) for non-procedural clinically-relevant bleeding. The primary endpoint outcomes were similar in the per-protocol [sHR 0.80 (95% CI 0.54-1.18), p=0.25] and on-treatment [sHR 0.82 (95% CI 0.56-1.20), p=0.30] analyses.
CONCLUSION


In long-term follow-up of PRAGUE-17, LAAC remains non-inferior to NOACs for preventing major cardiovascular, neurological or bleeding events. Furthermore, non-procedural bleeding was significantly reduced with LAAC.",2021,"The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically-relevant bleeding, or procedure/device-related complications (LAAC group only).","['402 AF patients (201 per group, age 73.3±7.0 years, 65.7% male, CHA 2 DS 2 -VASc 4.7+1.5, HASBLED 3.1+0.9', 'Atrial Fibrillation', 'non-valvular AF patients with a history of cardioembolism, clinically-relevant bleeding, or both CHA 2 DS 2 -VASc > 3 and HASBLED > 2', 'high-risk patients with atrial fibrillation (AF']","['warfarin oral anticoagulants (NOAC', 'left atrial appendage closure (LAAC', 'percutaneous LAAC (Watchman or Amulet) with NOACs (95% apixaban', 'Left Atrial Appendage Closure versus Non-Warfarin Oral Anticoagulation']","['similar in the per-protocol [sHR 0.80', 'modified intention-to-treat (mITT', 'non-procedural bleeding', 'composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically-relevant bleeding, or procedure/device-related complications', 'cardiovascular death']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C4759306', 'cui_str': 'Left atrial appendage closure'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}, {'cui': 'C0335390', 'cui_str': 'Watchman'}, {'cui': 'C0642228', 'cui_str': 'N(4)-oleylcytosine arabinoside'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1439030', 'cui_str': 'SHORT ROOT protein, Arabidopsis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C3203457', 'cui_str': 'Procedural haemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",402.0,0.464088,"The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically-relevant bleeding, or procedure/device-related complications (LAAC group only).","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Osmancik', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic. Electronic address: pavel.osmancik@gmail.com.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Herman', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Neuzil', 'Affiliation': 'Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Hala', 'Affiliation': 'Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Taborsky', 'Affiliation': 'Cardiocenter, Dept. of Cardiology, University Hospital Olomouc, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kala', 'Affiliation': 'Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Poloczek', 'Affiliation': 'Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Stasek', 'Affiliation': '1(st) Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University Prague, Czech Republic.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Haman', 'Affiliation': '1(st) Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University Prague, Czech Republic.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Branny', 'Affiliation': 'Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Chovancik', 'Affiliation': 'Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Cervinka', 'Affiliation': 'Department of Cardiology, Krajská zdravotni a.s., Masaryk hospital and UJEP, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Holy', 'Affiliation': 'Department of Cardiology, Krajská zdravotni a.s., Masaryk hospital and UJEP, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kovarnik', 'Affiliation': 'Cardiocenter, 2nd internal clinic - Cardiology and Angiology, Charles University, General Faculty Hospital, Prague Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zemanek', 'Affiliation': 'Cardiocenter, 2nd internal clinic - Cardiology and Angiology, Charles University, General Faculty Hospital, Prague Czech Republic.'}, {'ForeName': 'Stepan', 'Initials': 'S', 'LastName': 'Havranek', 'Affiliation': 'Cardiocenter, 2nd internal clinic - Cardiology and Angiology, Charles University, General Faculty Hospital, Prague Czech Republic.'}, {'ForeName': 'Vlastimil', 'Initials': 'V', 'LastName': 'Vancura', 'Affiliation': 'Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Peichl', 'Affiliation': 'Cardiocenter, Institute of Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Tousek', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Lekesova', 'Affiliation': 'Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Jarkovsky', 'Affiliation': 'Institute of Biostatistics and Analysis, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Novackova', 'Affiliation': 'Institute of Biostatistics and Analysis, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Benesova', 'Affiliation': 'Institute of Biostatistics and Analysis, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Widimsky', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Vivek Y', 'Initials': 'VY', 'LastName': 'Reddy', 'Affiliation': 'Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic; Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: vivek.reddy@mountsinai.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.10.023']
2428,34749395,Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort.,"Polatuzumab vedotin plus bendamustine and rituximab (pola+BR) received regulatory approvals in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) based on primary results from the randomized arms of the GO29365 study. Following the randomized phase, 106 additional patients received pola+BR in a single-arm extension cohort. We report updated results from the randomized arms, and results of the extension cohort. In this phase Ib/II study, patients with R/R DLBCL who were transplant-ineligible received up to six 21-day cycles of pola+BR or BR. The primary endpoint of the randomized arms was complete response (CR) rate at end of treatment. Primary objectives of the extension cohort were safety, pharmacokinetics, and efficacy of pola+BR. As of July 7, 2020, 192 patients with R/R DLBCL were enrolled into pola+BR cohorts (n=152 [safety run-in: n=6; randomized: n=40; extension cohort: n=106]) or the BR cohort (n=40). Significant survival benefit with pola+BR versus BR persisted in the randomized arms (median progression-free survival [PFS]: 9.2 vs 3.7 months, hazard ratio [HR]: 0.42, 95% confidence interval [CI] 0.25-0.71 months; median overall survival [OS]: 12.4 vs 4.7 months, HR: 0.42, 95% CI 0.24-0.72 months). In the extension cohort, the independent review committee (IRC)-assessed objective response rate was 41.5% and CR rate was 38.7%; median IRC-assessed PFS and OS were 6.6 months and 12.5 months, respectively. No new safety signals with pola+BR were identified. Pola+BR is an effective treatment option for patients with R/R DLBCL, with a well-characterized and manageable safety profile. ClinicalTrials.gov: NCT02257567.",2021,"Significant survival benefit with pola+BR versus BR persisted in the randomized arms (median progression-free survival [PFS]: 9.2 vs 3.7 months, hazard ratio [HR]: 0.42, 95% confidence interval [CI] 0.25-0.71 months; median overall survival [OS]: 12.4 vs 4.7 months, HR:","['192 patients with R/R DLBCL were enrolled into pola+BR cohorts (n=152 [safety run-in: n=6; randomized: n=40; extension cohort: n=106]) or the BR cohort (n=40', 'relapsed/refractory DLBCL', '106 additional patients received', 'patients with R/R DLBCL who were transplant-ineligible']","['Pola+BR', 'Polatuzumab vedotin plus bendamustine and rituximab (pola+BR', 'pola+BR', 'Polatuzumab vedotin plus bendamustine and rituximab']","['complete response (CR) rate', 'safety, pharmacokinetics, and efficacy of pola+BR']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0855112', 'cui_str': 'Diffuse large B-cell lymphoma refractory'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C4078806', 'cui_str': 'polatuzumab vedotin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",192.0,0.158428,"Significant survival benefit with pola+BR versus BR persisted in the randomized arms (median progression-free survival [PFS]: 9.2 vs 3.7 months, hazard ratio [HR]: 0.42, 95% confidence interval [CI] 0.25-0.71 months; median overall survival [OS]: 12.4 vs 4.7 months, HR:","[{'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'BC Cancer, Vancouver, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hertzberg', 'Affiliation': 'Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Opat', 'Affiliation': 'Monash Health, Clayton, Australia.'}, {'ForeName': 'Alex F', 'Initials': 'AF', 'LastName': 'Herrera', 'Affiliation': 'City of Hope National Medical Center, Duarte, California, United States.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Assouline', 'Affiliation': 'Jewish General Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Flowers', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Tae Min', 'Initials': 'TM', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, Korea, Republic of.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'McMillan', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Muhit', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': 'Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Violaine', 'Initials': 'V', 'LastName': 'Safar', 'Affiliation': 'Hospices Civils de Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Gilles Andre', 'Initials': 'GA', 'LastName': 'Salles', 'Affiliation': '10Centre Hospitalier Lyon-Sud, France.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ku', 'Affiliation': 'Genentech, Inc., South San Francisco, California, United States.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hirata', 'Affiliation': 'Genentech, Inc., South San Francisco, California, United States.'}, {'ForeName': 'Yi Meng', 'Initials': 'YM', 'LastName': 'Chang', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Mississauga, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Musick', 'Affiliation': 'Genentech, Inc., South San Francisco, California, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Matasar', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, New York, United States.'}]",Blood advances,['10.1182/bloodadvances.2021005794']
2429,34749319,[PHYSICAL THERAPEUTIC FACTORS IN STAGE MEDICAL REHABILITATION OF PUERPERAS WITH PERINEAL WOUNDS AFTER FETAL VACUUM EXTRACTION].,"Objective - to assess the role of physical therapeutic factors in the staged medical rehabilitation of puerperas with perineal wounds after fetal vacuum extraction. A comparative analysis of the postpartum period was carried out in 154 puerperas with perineal injuries after fetal vacuum extraction. Three groups were formed by simple randomization: patients in the control group (54 women) received standard treatment only; the experimental group (51 women) received standard treatment and low-intensity magnetic laser therapy (LLLT); the main group (49 women) underwent additional extracorporeal magnetic stimulation. Staged physiotherapy provided an increase in the strength of the pelvic floor muscles in patients of the main group by 47.9% (p<0.01), experimental group - by 36.2% (p<0.01), and control - by 24.4% (p <0.05); a decrease in the number of postoperative complications was by 6.5, 4.6, and 2.63 times, respectively. The use of staged physiotherapy in puerperas with perineal wounds after delivery operations provides a statistically significant improvement in clinical and functional parameters in comparison with the use of only standard treatment and its combination with NMLT.",2021,"Staged physiotherapy provided an increase in the strength of the pelvic floor muscles in patients of the main group by 47.9% (p<0.01), experimental group - by 36.2% (p<0.01), and control - by 24.4% (p <0.05); a decrease in the number of postoperative complications was by 6.5, 4.6, and 2.63 times, respectively.","['154 puerperas with perineal injuries after fetal vacuum extraction', 'puerperas with perineal wounds after fetal vacuum extraction']","['standard treatment only; the experimental group (51 women) received standard treatment and low-intensity magnetic laser therapy (LLLT); the main group (49 women) underwent additional extracorporeal magnetic stimulation', 'staged physiotherapy', 'NMLT']","['clinical and functional parameters', 'strength of the pelvic floor muscles', 'number of postoperative complications']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C3544174', 'cui_str': 'Perineal injury'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0042225', 'cui_str': 'Delivery by vacuum extraction'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",154.0,0.00821058,"Staged physiotherapy provided an increase in the strength of the pelvic floor muscles in patients of the main group by 47.9% (p<0.01), experimental group - by 36.2% (p<0.01), and control - by 24.4% (p <0.05); a decrease in the number of postoperative complications was by 6.5, 4.6, and 2.63 times, respectively.","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Uzdenova', 'Affiliation': '1FSBEI HE Kh.M. Berbekov Kabardino-Balkarian State University, Nalchik; Russia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zalikhanova', 'Affiliation': '1FSBEI HE Kh.M. Berbekov Kabardino-Balkarian State University, Nalchik; Russia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Gatagazheva', 'Affiliation': '2FSBEI HE Ingush State University, Nazran, Russia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Shavaeva', 'Affiliation': '1FSBEI HE Kh.M. Berbekov Kabardino-Balkarian State University, Nalchik; Russia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Marshenkulova', 'Affiliation': '1FSBEI HE Kh.M. Berbekov Kabardino-Balkarian State University, Nalchik; Russia.'}]",Georgian medical news,[]
2430,34749275,Effects of a structured online educational program course on nursing students' attitudes toward gender roles and women and children's violence abuse reports: A quasi-experimental evaluation.,"BACKGROUND


It is important to know the rights of women and children while shaping attitudes toward gender roles, violence against women, and reporting child abuse. To shape attitudes toward reporting abuse, women's and children's rights courses should be integrated into undergraduate nursing curriculum. It is important to develop positive attitudes of nursing students toward gender roles, violence against women, and reporting child abuse.
OBJECTIVES


The aim of the study was to evaluate the effects of a ""women's-children's rights"" online-educational program in a nursing curricula.
DESIGN


A pretest-posttest follow-up with a control group quasi-experimental trial.
SETTINGS


Nursing department of the state university in Turkey.
PARTICIPANTS


Fourth-year students (N = 62) of a nursing department at the state university in Turkey constituted the study sample. The students were divided into two groups: education and control groups with each group comprising 31 fourth-year nursing students.
METHODS


The education group took the women's-children's rights online-course, whereas the control group did not. In both groups, baseline assessments were performed online using the ""Gender Roles Attitude Scale,"" ""Violence Against Women Attitude Scale,"" and ""Healthcare Provider Attitudes Toward Child Maltreatment Reporting Scale."" The posttest (T1) was conducted immediately after the 14-week course was completed. Follow-up was performed after 1 month (T2). Numbers, percentages, chi-square test, t-test, Kolmogorov-Smirnov test, Pearson's correlation, and Duncan's test were conducted using SPSS 20.00 software.
RESULTS


The education group's scores of attitudes toward gender roles, violence against women, and reporting child abuse/neglect were significantly higher than those of the control group (p < 0.05). After the online program, a significant difference between the groups and between the measurements was observed in the education group (p < 0.05).
CONCLUSIONS


The women's-children's rights online-course is an effective method in educating and enriching nursing students on women's and children's rights.",2021,The women's-children's rights online-course is an effective method in educating and enriching nursing students on women's and children's rights.,"[""nursing students' attitudes toward gender roles and women and children's violence abuse reports"", 'Nursing department of the state university in Turkey', 'Fourth-year students (N\xa0=\xa062) of a nursing department at the state university in Turkey constituted the study sample']","['structured online educational program course', 'women\'s-children\'s rights"" online-educational program']","['Gender Roles Attitude Scale,"" ""Violence Against Women Attitude Scale,"" and ""Healthcare Provider Attitudes Toward Child Maltreatment Reporting Scale', ""Numbers, percentages, chi-square test, t-test, Kolmogorov-Smirnov test, Pearson's correlation, and Duncan's test"", 'scores of attitudes toward gender roles, violence against women, and reporting child abuse/neglect']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0017253', 'cui_str': 'Gender Role'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0376485', 'cui_str': 'Abuse Reporting'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242925', 'cui_str': 'Kolmogorov-Smirnov Test'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017253', 'cui_str': 'Gender Role'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}]",,0.0265815,The women's-children's rights online-course is an effective method in educating and enriching nursing students on women's and children's rights.,"[{'ForeName': 'Fatma Dilek', 'Initials': 'FD', 'LastName': 'Turan', 'Affiliation': 'Aksaray University, Faculty of Health Science, Pediatric Nursing Department, 68100, Aksaray, Turkey. Electronic address: Fatmadilek_32@hotmail.com.'}]",Nurse education today,['10.1016/j.nedt.2021.105191']
2431,34749586,Impact of resistance training on muscle fatigue in type 2 diabetes mellitus patients during dynamic fatigue protocol.,"BACKGROUND


Type 2 diabetes mellitus (T2DM) is often accompanied with several neuromuscular complications of which muscle fatigue is one of the scantily studied and less-explored complication of this disease.
OBJECTIVE


To investigate the effects of resistance training (RT) on muscle fatigue markers from electromyography (EMG) and capillary blood in T2DM patients.
METHODS


Forty T2DM patients were randomized to either RT (n = 20) or control group (n = 20). They were assessed for EMG indices of muscle fatigue along with blood lactate (at three time points: Lactate pre , Lactate peak , Lactate post ) during a dynamic fatigue protocol. Dynamic fatigue protocol consisted of 5 sets of leg press exercise at 10 repetition maximum intensity. RT group performed moderate intensity (65%-75% 1 repetition maximum) RT 3 times/week for 12 weeks. Control group followed usual routine.
RESULTS


Findings revealed that EMG amplitude (root mean square) and Dimitrov's muscle fatigue index (FI nsmk ) decreased significantly while median frequency (MF) increased significantly during the dynamic fatigue protocol for both vastus medialis (Root mean square,  p  = .02; FI nsmk ,  p  = .001; MF,  p  < .001) and vastus lateralis muscle (Root mean square,  p = .04,FI nsmk, p  = .01; MF,  p  < .001) post-RT. Blood lactate responses did not change after RT (Lactate pre ,  p  = .55; Lactate peak ,  p  = .91; Lactate post ,  p  = .33).
CONCLUSIONS


Findings of the present study illustrated that moderate intensity RT led to a significant reduction muscle fatigue in knee extensor muscles of T2DM patients. These results reinforce the utilization of RT in patients with T2DM.",2021,"MF,  p  < .001) and vastus lateralis muscle (Root mean square,  p = .04,FI nsmk, p  = .01; MF,  p  < .001) post-RT.","['T2DM patients', 'Forty T2DM patients', 'Type 2 diabetes mellitus (T2DM', 'type 2 diabetes mellitus patients during dynamic fatigue protocol', 'patients with T2DM']","['resistance training', 'resistance training (RT', 'leg press exercise', 'Control group followed usual routine', 'RT']","['median frequency (MF', 'Blood lactate responses', 'muscle fatigue', 'EMG indices of muscle fatigue along with blood lactate', 'vastus lateralis muscle', ""EMG amplitude (root mean square) and Dimitrov's muscle fatigue index (FI nsmk "", 'moderate intensity']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]",40.0,0.0261226,"MF,  p  < .001) and vastus lateralis muscle (Root mean square,  p = .04,FI nsmk, p  = .01; MF,  p  < .001) post-RT.","[{'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Bhati', 'Affiliation': 'Faculty of Allied Health Sciences, Shree Guru Gobind Singh Tricentenary University, Gurugram, Haryana, 122505, India.'}, {'ForeName': 'M Ejaz', 'Initials': 'ME', 'LastName': 'Hussain', 'Affiliation': 'Faculty of Physiotherapy and Allied Health Sciences, Shree Guru Gobind Singh Tricentenary University, Chandu-Budhera, Gurugram, India.'}]",Physiotherapy theory and practice,['10.1080/09593985.2021.2001882']
2432,34749585,A cohort study of the efficacy of the dienogest and the gonadotropin-releasing hormone agonist in women with adenomyosis and dysmenorrhea.,"PURPOSE


To study the efficacy and safety of the dienogest and the gonadotropin-releasing hormone agonist (GnRH-a) in symptomatic females with uterine adenomyosis.
METHODS


A total of 127 patients with adenomyosis with a chief complaint of dysmenorrhea were recruited. The first group received 2 mg of dienogest (DNG) daily, whereas the second group received goserelin acetate (GS) (3.6 mg/4 weeks) for 12 weeks. Outpatient follow-up was undertaken after 12 weeks.
RESULTS


Among 127 women, 56/63 (88.9%) patients completed the treatment in the DNG group, whereas 62/64 (96.9%) patients completed the treatment in the GS group. A significant decrease in dysmenorrhea symptoms as measured by the visual analog scale (VAS) and Carcinoma antigen125 (CA125) after 12 weeks of treatment was observed in both groups ( p  < .001). The hemoglobin of anemic patients did not significantly improve after 12 weeks of treatment ( p ＝0.21) and the uterine volume slightly increased without statistical significance ( p ＝0.10) in the DNG group. Simultaneously, The hemoglobin of anemic patients significantly improved ( p  < .001) and the uterine volume significantly decreased ( p  < .001) in the GS group.
CONCLUSIONS


Dienogest effectively alleviates the symptoms of dysmenorrhea in patients with adenomyosis, but it cannot improve the anemia or reduce the size of the uterus. GnRH-a is more effective in improving anemia and reducing the uterine volume in patients with adenomyosis.  TRIAL REGISTRATION:  ChiCTR1900024958.",2021,The hemoglobin of anemic patients did not significantly improve after 12 weeks of treatment ( p ＝0.21) and the uterine volume slightly increased without statistical significance ( p ＝0.10) in the DNG group.,"['127 women, 56/63 (88.9%) patients completed the treatment in the DNG group, whereas 62/64 (96.9%) patients completed the treatment in the GS group', '127 patients with adenomyosis with a chief complaint of dysmenorrhea were recruited', 'symptomatic females with uterine adenomyosis', 'women with adenomyosis and dysmenorrhea', 'patients with adenomyosis']","['goserelin acetate (GS', 'gonadotropin-releasing hormone agonist (GnRH-a', '2\u2009mg of dienogest (DNG', 'gonadotropin-releasing hormone agonist']","['dysmenorrhea symptoms', 'visual analog scale (VAS) and Carcinoma antigen125 (CA125', 'symptoms of dysmenorrhea', 'uterine volume']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0700476', 'cui_str': 'Goserelin acetate'}, {'cui': 'C0341858', 'cui_str': 'Endometriosis of uterus'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0700476', 'cui_str': 'Goserelin acetate'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}]","[{'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",127.0,0.0294553,The hemoglobin of anemic patients did not significantly improve after 12 weeks of treatment ( p ＝0.21) and the uterine volume slightly increased without statistical significance ( p ＝0.10) in the DNG group.,"[{'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Ji', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Qiuju', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Guoyun', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2021.2000961']
2433,34749577,Effects of plyometric jump training versus power training using free weights on measures of physical fitness in youth male soccer players.,"This study aimed to contrast the effects of power training (PT) and plyometric-jump-training (PJT) programmes on measures of physical fitness in prepubertal male soccer players. Thirty-three participants were randomly allocated to PT group (n = 11), PJT group (n = 11), and an active control group (CG; n = 11). Before and after 12 weeks of training, tests were performed for the assessment of sprint-speed , change-of-direction (CoD) speed, muscular strength , and aerobic-endurance (AE). Findings indicated significant group×time interaction effects for all sprint-speed intervals, CoD speed, AE, and strength ( d  = 0.20-0.32). Post-hoc analyses revealed significant, moderate-to-large improvements in all sprint-speed intervals, CoD speed, AE, and muscle strength following PT (ES = 0.71 to 1.38). The PJT induced significant, moderate-to-large enhancements in 10 m, 20 m, and 30 m sprint, CoD speed, and AE (ES = 0.51 to 0.96) with no significant changes for 5 m sprint-speed and muscle strength (ES = 0.71 and 0.16, respectively). No significant pre-post changes were observed for the CG . Overall, PT and PJT are effective means to improve various measures of physical fitness in prepubertal male soccer players. Notably, to additionally improve acceleration and muscle strength, PT has an advantage over PJT.",2021,"Findings indicated significant group×time interaction effects for all sprint-speed intervals, CoD speed, AE, and strength ( d  = 0.20-0.32).","['youth male soccer players', 'Thirty-three participants', 'prepubertal male soccer players']","['plyometric jump training versus power training', 'PJT', 'power training (PT) and plyometric-jump-training (PJT) programmes', 'PT']","['physical fitness', 'group×time interaction effects for all sprint-speed intervals, CoD speed, AE, and strength', 'sprint-speed intervals, CoD speed, AE, and muscle strength', '5 m sprint-speed and muscle strength', 'sprint-speed , change-of-direction (CoD) speed, muscular strength , and aerobic-endurance (AE']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0450358', 'cui_str': '33'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",33.0,0.00930908,"Findings indicated significant group×time interaction effects for all sprint-speed intervals, CoD speed, AE, and strength ( d  = 0.20-0.32).","[{'ForeName': 'Senda', 'Initials': 'S', 'LastName': 'Sammoud', 'Affiliation': 'Research Unit (Ur17js01) «sport Performance, Health & Society», Higher Institute of Sport and Physical Education of Ksar Saïd, University of ""La Manouba"", Tunisia.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Bouguezzi', 'Affiliation': 'Research Unit (Ur17js01) «sport Performance, Health & Society», Higher Institute of Sport and Physical Education of Ksar Saïd, University of ""La Manouba"", Tunisia.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Department of Physical Activity Sciences. Universidad De Los Lagos. Santiago, Chile.'}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Negra', 'Affiliation': 'Research Unit (Ur17js01) «sport Performance, Health & Society», Higher Institute of Sport and Physical Education of Ksar Saïd, University of ""La Manouba"", Tunisia.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Prieske', 'Affiliation': 'Division of Exercise and Movement, University of Applied Sciences for Sports and Management Potsdam, Potsdam, Germany.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Moran', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Sciences, University of Essex, Colchester, Essex, UK.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'Faculty of Human Sciences, Department of Sports and Health Sciences, University of Potsdam, Potsdam, Germany.'}]",Journal of sports sciences,['10.1080/02640414.2021.1976570']
2434,34749555,"Assessing safety and success after using bevacizumab, 5-fluorouracil or placebo in primary trabeculectomy. A Prospective Randomized placebo controlled 1-Year Follow-up Study.","PURPOSE


The aim of this study was to determine whether glaucoma patients after trabeculectomy could benefit more from subconjunctival injections of bevacizumab than 5-FU or placebo.
METHODS AND RESULTS


Fifty-one eyes of 51 patients were recruited for primary MMC (0.2mg/ml for 1 min) augmented trabeculectomy. 17 patients were randomly assigned to receive 1.25mg (0.05ml) of bevacizumab augmentation, 21 patients were assigned to receive 0.1ml of 50mg/ml 5-FU and 13 patients were assigned to a control group receiving a normal saline injection as a placebo. Initial recruitment included 58 patients, but seven patients had to be excluded from the study for various reasons. Postoperative follow up of IOP and bleb characteristics was carried out at 1 day, 1 week, 3 weeks, 6 weeks, 6 months and 1 year after surgery. All analyses where carried out by two masked clinicians. IOP reduction was statistically significant (P < 0.05) across all three groups between baseline visit and final 1-year postoperative visit. There was no significant difference of the final average IOP values between the three groups. Bleb evaluation was made using the Moorfields bleb grading system (MBGS) after 1 year follow up. Central bleb area was statistically greater in the Bevacizumab group when compared with the 5-FU group but not with the placebo group. The vascularity of the central bleb was significantly different between the groups with the Bevacizumab group showing the least vascularity. Vascularity of the peripheral bleb was also decreased in the Bevacizumab group when compared with the placebo group but not with the 5-FU group.
CONCLUSION


The 12-month IOP results showed no significant differences between the groups of patients after Bevacizumab, 5-FU or placebo to augment primary MMC enhanced trabeculectomy. However, by the analysis of bleb morphology there was a significant difference in terms of central bleb area and vascularity.",2021,"The 12-month IOP results showed no significant differences between the groups of patients after Bevacizumab, 5-FU or placebo to augment primary MMC enhanced trabeculectomy.","['58 patients, but seven patients had to be excluded from the study for various reasons', 'glaucoma patients after', 'primary trabeculectomy', 'Fifty-one eyes of 51 patients were recruited for primary MMC (0.2mg/ml for 1\u2009min) augmented', '17 patients']","['5-FU', 'bevacizumab augmentation', 'bevacizumab', 'trabeculectomy', 'control group receiving a normal saline injection as a placebo', 'bevacizumab, 5-fluorouracil or placebo', 'Bevacizumab', 'Bevacizumab, 5-FU or placebo', 'placebo', '5-FU or placebo', 'ml 5-FU']","['Vascularity of the peripheral bleb', 'Central bleb area', 'IOP reduction', 'trabeculectomy', 'vascularity of the central bleb', 'final average IOP values', 'central bleb area and vascularity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",58.0,0.228601,"The 12-month IOP results showed no significant differences between the groups of patients after Bevacizumab, 5-FU or placebo to augment primary MMC enhanced trabeculectomy.","[{'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Kandarakis', 'Affiliation': 'Department of Ophthalmology, National and Kapodistrian University of Athens, 1st University Eye Clinic, G. Gennimatas General Hospital, Athens, Greece.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Kontaxakis', 'Affiliation': 'Department of Ophthalmology, National and Kapodistrian University of Athens, 1st University Eye Clinic, G. Gennimatas General Hospital, Athens, Greece.'}, {'ForeName': 'Leonidas', 'Initials': 'L', 'LastName': 'Doumazos', 'Affiliation': 'Department of Ophthalmology, National and Kapodistrian University of Athens, 1st University Eye Clinic, G. Gennimatas General Hospital, Athens, Greece.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Petrou', 'Affiliation': 'Department of Ophthalmology, National and Kapodistrian University of Athens, 1st University Eye Clinic, G. Gennimatas General Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Droutsas', 'Affiliation': 'Department of Ophthalmology, National and Kapodistrian University of Athens, 1st University Eye Clinic, G. Gennimatas General Hospital, Athens, Greece.'}, {'ForeName': 'Demetrios', 'Initials': 'D', 'LastName': 'Papaconstantinou', 'Affiliation': 'Department of Ophthalmology, National and Kapodistrian University of Athens, 1st University Eye Clinic, G. Gennimatas General Hospital, Athens, Greece.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Georgalas', 'Affiliation': 'Department of Ophthalmology, National and Kapodistrian University of Athens, 1st University Eye Clinic, G. Gennimatas General Hospital, Athens, Greece.'}]",Cutaneous and ocular toxicology,['10.1080/15569527.2021.2003376']
2435,34749549,Functional high-intensity interval training is not equivalent when compared to combined training for blood pressure improvements in postmenopausal women: a randomized controlled trial.,"INTRODUCTION


Low-volume functional high-intensity interval training (F-HIIT) improves cardiorespiratory fitness, body composition, and physical function similarly to combined training (CT, gold standard protocol), however no previous studies have compared the F-HIIT equivalence with CT in reducing blood pressure in older people, particularly in postmenopausal women (PW). Therefore, the aim of this study (trial registration: NCT03200639) was designed to test whether F-HIIT of low volume is an equivalent strategy to CT for improving blood pressure (BP) in PW.
MATERIAL AND METHOD


Forty-nine PW were divided into two groups: F-HIIT and CT. The F-HIIT protocol was composed of 10 sets of 60 seconds of high-intensity exercises interspersed with 60 seconds of low-intensity exercises for recovery. The CT protocol was composed of 30 minutes of moderate-intensity walking, followed by five total body resistance exercises. Both protocols were performed 3-times-a-week for 12 weeks. The BP from rest condition (before exercise) was measured before and after 12 weeks of intervention in both groups, using an automatic blood pressure monitor. The boundaries values for equivalence for systolic and diastolic BP was set at 5.14 and 2.92 mmHg, respectively.
RESULTS


There was only a significant reduction ( P  < .05) in systolic BP in CT group from baseline (-3.2 (95% CI, -6.2 to -0.2) mmHg). The difference of systolic BP between F-HIIT and CT was 5.8 (95% CI, 1.3-10.4) mmHg, showing non-equivalence (inferiority) for F-HIIT.
CONCLUSION


Thus, these results suggest that low-volume F-HIIT protocol is not an equivalent strategy when compared to CT for BP improvements in PW.",2021,"There was only a significant reduction ( P  < .05) in systolic BP in CT group from baseline (-3.2 (95% CI, -6.2 to -0.2) mmHg).","['older people, particularly in postmenopausal women (PW', 'postmenopausal women', 'Forty-nine PW']","['Functional high-intensity interval training', 'CT', 'F-HIIT and CT', 'Low-volume functional high-intensity interval training (F-HIIT', 'combined training', 'high-intensity exercises interspersed with 60\xa0seconds of low-intensity exercises']","['systolic BP', 'systolic and diastolic BP', 'cardiorespiratory fitness, body composition, and physical function', 'blood pressure', 'blood pressure improvements', 'blood pressure (BP']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",49.0,0.0673699,"There was only a significant reduction ( P  < .05) in systolic BP in CT group from baseline (-3.2 (95% CI, -6.2 to -0.2) mmHg).","[{'ForeName': 'Paulo R P', 'Initials': 'PRP', 'LastName': 'Nunes', 'Affiliation': 'Exercise Biology Laboratory (BioEx), Federal University of Triângulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Thalles R G B', 'Initials': 'TRGB', 'LastName': 'Silva', 'Affiliation': 'Exercise Biology Laboratory (BioEx), Federal University of Triângulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Marcelo A S', 'Initials': 'MAS', 'LastName': 'Carneiro', 'Affiliation': 'Exercise Biology Laboratory (BioEx), Federal University of Triângulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Fernanda M', 'Initials': 'FM', 'LastName': 'Martins', 'Affiliation': 'Exercise Biology Laboratory (BioEx), Federal University of Triângulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Aletéia P', 'Initials': 'AP', 'LastName': 'Souza', 'Affiliation': 'Exercise Biology Laboratory (BioEx), Federal University of Triângulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Fábio L', 'Initials': 'FL', 'LastName': 'Orsatti', 'Affiliation': 'Exercise Biology Laboratory (BioEx), Federal University of Triângulo Mineiro (UFTM), Minas Gerais, Brazil.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2021.2001481']
2436,34749509,Investigation of the implementation of a Communication Enhanced Environment model on an acute/slow stream rehabilitation and a rehabilitation ward: A before-and-after pilot study.,"OBJECTIVES


Develop and implement a Communication Enhanced Environment model and explore its effect on language activities for patients early after stroke.
METHOD AND DESIGN


Before-and-after pilot study.
SETTING


An acute/slow stream rehabilitation and a rehabilitation ward in a private hospital in Perth, Western Australia.
PARTICIPANTS


Fourteen patients recruited within 21 days of stroke. Seven recruited during the before-phase (control group: patients with aphasia = 3, patients without aphasia = 4) and seven recruited in the after-phase (intervention group: patients with aphasia = 4, patients without aphasia = 3).
INTERVENTION


The intervention group exposed to a Communication Enhanced Environment model had access to equipment, resources, planned social activities and trained communication partners. Both groups received usual stroke care.
DATA COLLECTION


Hospital site champions monitored the availability of the intervention. Behavioural mapping completed during the first minute of each 5-minute interval over 12 hours (between 7 am and 7 pm) determined patient engagement in language activities.
RESULTS


Seventy-one percent of the Communication Enhanced Environment model was available to the intervention group who engaged in higher, but not significant (95% CI), levels of language activities (600 of 816 observation time points, 73%) than the control group (551 of 835 observation time points, 66%). Unforeseen reorganisation of the acute ward occurred during the study.
CONCLUSIONS


Implementation of a Communication Enhanced Environment model was feasible in this specific setting and may potentially influence patients' engagement in language activities. The unforeseen contextual challenges that occurred during the study period demonstrate the challenging nature of the hospital environment and will be useful in future research planning.",2021,"The intervention group exposed to a Communication Enhanced Environment model had access to equipment, resources, planned social activities and trained communication partners.","['patients early after stroke', 'Seven recruited during the before-phase (control group: patients with aphasia = 3, patients without aphasia = 4) and seven recruited in the after-phase (intervention group: patients with aphasia = 4, patients without aphasia = 3', 'acute/slow stream rehabilitation and a rehabilitation ward', 'Fourteen patients recruited within 21 days of stroke', 'An acute/slow stream rehabilitation and a rehabilitation ward in a private hospital in Perth, Western Australia']","['Communication Enhanced Environment model had access to equipment, resources, planned social activities and trained communication partners', 'usual stroke care']","['language activities', 'Communication Enhanced Environment model', 'levels of language activities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",14.0,0.0132195,"The intervention group exposed to a Communication Enhanced Environment model had access to equipment, resources, planned social activities and trained communication partners.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': ""D'Souza"", 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Godecke', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ciccone', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hersh', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Armstrong', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Tucak', 'Affiliation': 'Hollywood Private Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Janssen', 'Affiliation': 'Hunter New England Local Health District, New Lambton Heights, NSW Health, NSW, Australia.'}]",Clinical rehabilitation,['10.1177/02692155211032655']
2437,34749425,Effect of intensive olfactory training for cognitive function in patients with dementia.,"AIM


Recent evidence has revealed an association between neurodegenerative disorders and olfactory dysfunction. However, whether olfactory training can improve cognitive impairment in patients with dementia requires further study. The present study aimed to resolve this by developing an intensive olfactory training (IOT) protocol and assessing its impact on each of the cognitive domains in patients with dementia.
METHODS


Patients were prospectively recruited between June 2020 and September 2020. Baseline evaluations included demographic data, olfactory function test, depression scale and detailed cognitive function tests. Thirty-four patients in the experimental group underwent IOT twice a day with a 40-odor set for 15 days, while 31 individuals in the control group received conservative management. Follow-up evaluations using the depression scale and detailed cognitive function tests were performed after IOT.
RESULTS


Baseline characteristics were not different between the two groups. The IOT group showed significant improvements in depression, attention, memory and language functions, but not global cognition, frontal executive, or visuospatial functions compared with the control group.
CONCLUSION


This study shows the ability of IOT to alleviate depression and improve some cognitive functions in patients with dementia. These results suggest that IOT may be an effective non-pharmacological approach for improving the symptoms of dementia. Geriatr Gerontol Int ••; ••: ••-•• Geriatr Gerontol Int 2021; ••: ••-••.",2021,"The IOT group showed significant improvements in depression, attention, memory and language functions, but not global cognition, frontal executive, or visuospatial functions compared with the control group.
","['patients with dementia', 'Patients were prospectively recruited between June 2020 and September 2020']","['intensive olfactory training', 'intensive olfactory training (IOT) protocol', 'conservative management', 'olfactory training', 'IOT']","['depression scale and detailed cognitive function tests', 'cognitive impairment', 'demographic data, olfactory function test, depression scale and detailed cognitive function tests', 'depression, attention, memory and language functions, but not global cognition, frontal executive, or visuospatial functions', 'cognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}]",,0.0217939,"The IOT group showed significant improvements in depression, attention, memory and language functions, but not global cognition, frontal executive, or visuospatial functions compared with the control group.
","[{'ForeName': 'Hyegyeong', 'Initials': 'H', 'LastName': 'Cha', 'Affiliation': 'Department of Nursing, Namseoul University, Cheonan-si, Republic of Korea.'}, {'ForeName': 'Sisook', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Namseoul University, Cheonan-si, Republic of Korea.'}, {'ForeName': 'Hansong', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Namgung Hospital, Cheongju-si, Republic of Korea.'}, {'ForeName': 'Gaeyoung', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Graduate School of Chung-Ang University, Seoul, Republic of Korea.'}, {'ForeName': 'Kyum-Yil', 'Initials': 'KY', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Soonchunhyang University Seoul Hospital, Soonchunhyang University School of Medicine, Seoul, Republic of Korea.'}]",Geriatrics & gerontology international,['10.1111/ggi.14287']
2438,34749418,Interval Training with Different Intensities in Overweight/Obese Adolescent Females.,"To compare the effects of 12 weeks of high-intensity interval training (HIIT) versus moderate-intensity interval training (MIIT) on hematological and inflammatory markers in youth females, 38 overweight/obese females (16.4±1.0 yrs.) were randomly assigned to HIIT (2×6-8 repetitions of 30 s at 100-110% maximal aerobic speed (MAS), with 30 s active recovery between repetitions at 50% MAS; n=13), MIIT (2×6-8 repetitions of 30 s at 70-80% MAS, with 30 s active recovery between repetitions at 50% MAS; n=13), and a control group (CG, no intervention; n=12). Body composition, blood pressure, maximal heart rate, hematological and inflammatory markers (C-reactive protein [CRP], and erythrocyte sedimentation rate [ESR]) markers were assessed in all groups before and following the training program. Results revealed a significant (P<0.05) interaction effect for body composition, systolic blood pressure (SBP), MAS, maximal heart rate, and CRP. Within-group analyses for the HIIT and MIIT groups showed significant improvements in body mass (P=0.009 and P=0.025, respectively), BMI Z-score (P=0.011 and P=0.028, respectively), and MAS (P<0.001 and P=0.011, respectively). The HIIT program showed a significant decrease in body fat (P=0.002), waist circumference (P=0.002), maximal heart rate (P=0.003), SBP (P=0.001), and plasma CRP (P=0.004). In both groups, no significant changes were observed in ESR and hematological markers after intervention. No variable changed in CG. HIIT was the effective method to manage cardiometabolic health and inflammatory disorders in obese youth.",2021,"The HIIT program showed a significant decrease in body fat (P=0.002), waist circumference (P=0.002), maximal heart rate (P=0.003), SBP (P=0.001), and plasma CRP (P=0.004).","['youth females, 38 overweight/obese females (16.4±1.0\u2009yrs', 'Overweight/Obese Adolescent Females', 'obese youth']","['high-intensity interval training (HIIT) versus moderate-intensity interval training (MIIT', 'Interval Training']","['waist circumference', 'hematological and inflammatory markers', 'body mass', 'body composition, systolic blood pressure (SBP), MAS, maximal heart rate, and CRP', 'Body composition, blood pressure, maximal heart rate, hematological and inflammatory markers (C-reactive protein [CRP], and erythrocyte sedimentation rate [ESR]) markers', 'ESR and hematological markers', 'MAS', 'SBP', 'maximal heart rate', 'plasma CRP', 'BMI Z-score', 'body fat', 'CG']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",,0.016944,"The HIIT program showed a significant decrease in body fat (P=0.002), waist circumference (P=0.002), maximal heart rate (P=0.003), SBP (P=0.001), and plasma CRP (P=0.004).","[{'ForeName': 'Wissal', 'Initials': 'W', 'LastName': 'Abassi', 'Affiliation': 'University of Jendouba, High Institute of Sport and Physical Education of Kef, UR13JS01, 7100 Kef, Tunisia.'}, {'ForeName': 'Nejmeddine', 'Initials': 'N', 'LastName': 'Ouerghi', 'Affiliation': 'University of Jendouba, High Institute of Sport and Physical Education of Kef, UR13JS01, 7100 Kef, Tunisia.'}, {'ForeName': 'Pantelis T', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'School of Health and Caring Sciences, University of West Attica, Athens, Greece.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Division of Gastroenterology and Nutrition, Department of Pediatrics, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Ghazi', 'Initials': 'G', 'LastName': 'Racil', 'Affiliation': 'Higher Institute of Sport and Physical Education of Ksar Said, University of ""La Manouba"", Manouba 2010, Tunisia.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knechtle', 'Affiliation': 'Medbase St. Gallen Am Vadianplatz, St. Gallen, Switzerland.'}, {'ForeName': 'Moncef', 'Initials': 'M', 'LastName': 'Feki', 'Affiliation': 'University of Tunis El Manar, Faculty of Medicine of Tunis, Rabta Hospital, LR99ES11, 1007 Tunis, Tunisia.'}, {'ForeName': 'Anissa', 'Initials': 'A', 'LastName': 'Bouassida', 'Affiliation': 'University of Jendouba, High Institute of Sport and Physical Education of Kef, UR13JS01, 7100 Kef, Tunisia.'}]",International journal of sports medicine,['10.1055/a-1648-4653']
2439,34749410,Effect of Air Tamponade among Patients with Epiretinal Membranes and Intraretinal Cystoid Changes Undergoing Vitrectomy with Membrane Peeling - A Prospective Randomized Trial.,"BACKGROUND


The effect of air tamponade among patients undergoing vitrectomy with membrane peeling for removal of epiretinal membranes (ERM) is controversially discussed. The aim of the present study was to analyze differences in outcomes between air tamponade and balanced salt solution (BSS) in a study population with preoperative intraretinal cystoid changes.
PATIENTS AND METHODS


This randomized study included patients scheduled for pars plana vitrectomy with membrane peeling owing to ERM and intraretinal cystoid changes. Air tamponade or BSS at the end of surgery was applied according to preoperative randomization. Optical coherence tomography and best-corrected distance visual acuity (DCVA) measurements were performed before surgery, 5 days after surgery, and 3 months after surgery.
RESULTS


From 96 patients included, 85 eyes had full follow-up and could be included for analysis. Median improvement of DCVA was + 16 EDTRS letters (IQR: 8 to 22) among patients with BSS, while it was + 13 EDTRS letters (IQR: 8 to 17) among patients with air tamponade. There was a trend for better improvement of DCVA when BSS was left at the end of surgery, compared to air tamponade, but not reaching statistical significance.
CONCLUSIONS


There were no statistically significant differences concerning resorption of preoperative intraretinal cystoid changes, improvement of visual acuity, and final DVCA between air tamponade and BSS.",2021,"There were no statistically significant differences concerning resorption of preoperative intraretinal cystoid changes, improvement of visual acuity, and final DVCA between air tamponade and BSS.","['Patients with Epiretinal Membranes and Intraretinal Cystoid Changes', 'From 96 patients included, 85 eyes had full follow-up and could be included for analysis', 'patients undergoing vitrectomy with membrane peeling for removal of epiretinal membranes (ERM', 'study population with preoperative intraretinal cystoid changes', 'patients scheduled for pars plana vitrectomy with membrane peeling owing to ERM and intraretinal cystoid changes']","['air tamponade and balanced salt solution (BSS', 'Air Tamponade', 'Undergoing Vitrectomy with Membrane Peeling']","['resorption of preoperative intraretinal cystoid changes, improvement of visual acuity, and final DVCA between air tamponade and BSS', 'Optical coherence tomography and best-corrected distance visual acuity (DCVA) measurements', 'Median improvement of DCVA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C3653289', 'cui_str': 'Salt solutions'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C3653289', 'cui_str': 'Salt solutions'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",96.0,0.056238,"There were no statistically significant differences concerning resorption of preoperative intraretinal cystoid changes, improvement of visual acuity, and final DVCA between air tamponade and BSS.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Leisser', 'Affiliation': 'Augenabteilung, Hanusch-Krankenhaus, Wien, Österreich.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruiss', 'Affiliation': 'Vienna Institute for Research in Ocular Surgery, Hanusch-Krankenhaus, Wien, Österreich.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Pilwachs', 'Affiliation': 'Vienna Institute for Research in Ocular Surgery, Hanusch-Krankenhaus, Wien, Österreich.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Hienert', 'Affiliation': 'Augenabteilung, Hanusch-Krankenhaus, Wien, Österreich.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Stjepanek', 'Affiliation': 'Augenabteilung, Hanusch-Krankenhaus, Wien, Österreich.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Findl', 'Affiliation': 'Augenabteilung, Hanusch-Krankenhaus, Wien, Österreich.'}]",Klinische Monatsblatter fur Augenheilkunde,['10.1055/a-1610-9479']
2440,34749871,[Lipids-lowering effects of equol on low density lipoprotein receptor knockout hamsters].,"OBJECTIVE


Used low density lipoprotein receptor knockout(LDLR KO) hamster as the model similar to human dyslipidemia to observe the lipid-lowering effect of equol on heterozygotes.
METHODS


With soy-free high cholesterol high fat diet, 12-week-old LDLR KO female heterozygous hamsters were randomly divided into negative control group(no addition), positive control group(add 0.004% ezetimibe), genistein group(add 0.1%), and low, medium and high-dose groups of equol(add 0.025%, 0.05%, 0.1% respectively). Body weight, food consumption and blood lipid were continuously monitored for 12 weeks after feeding each group. Finally, liver morphology and lipid metabolism related genes expressions were checked.
RESULTS


There was no significant difference in body weight and average weekly food intake among the groups. The blood lipids in negative control group increased over time, and the cholesterol and triglyceride levels of LDLR KO heterozygous hamsters were significantly reduced by ezetimibe in the second week, while the high-density lipoprotein cholesterol was also significantly decreased. The lipid-lowering effects of genistein and equol were weaker than ezetimibe, and there was significant difference between the two groups after 12 weeks, but the decrease of HDL-c was not as significant as ezetimibe. Compared with genistein, the effect of medium and high dose equol was stronger. At 12 weeks, the liver weight ratio also decreased significantly, and the liver lipid accumulation was inhibited, especially in the high dose of equol. The expression of ApoAI, SREBP-2 and HMGCR were significantly up-regulated by equol and genistein.
CONCLUSION


Equol could reduce female LDLR KO hamster blood lipid. It may play a role in lipid lowering by inhibiting cholesterol absorption besides estrogen receptor pathway, but it is weaker than NPC1 L1 inhibitor. At the same time, up-regulation of ApoAI inhibits the decrease of high-density lipoprotein and reduces lipid accumulation in liver.",2021,"The expression of ApoAI, SREBP-2 and HMGCR were significantly up-regulated by equol and genistein.
",['old LDLR KO female heterozygous hamsters'],"['genistein', 'soy-free high cholesterol high fat diet', 'positive control group(add 0.004% ezetimibe), genistein', 'Equol', 'ezetimibe', 'equol']","['cholesterol and triglyceride levels of LDLR KO heterozygous hamsters', 'HDL-c', 'expression of ApoAI, SREBP-2 and HMGCR', 'lipid accumulation', 'high-density lipoprotein cholesterol', 'blood lipids', 'Body weight, food consumption and blood lipid', 'liver weight ratio', 'female LDLR KO hamster blood lipid', 'body weight and average weekly food intake', 'liver lipid accumulation']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0018557', 'cui_str': 'Subfamily Cricetinae'}]","[{'cui': 'C0061202', 'cui_str': 'Genistein'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0059497', 'cui_str': 'Equol'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0018557', 'cui_str': 'Subfamily Cricetinae'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C2975999', 'cui_str': 'HMGCR protein, human'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",,0.0108768,"The expression of ApoAI, SREBP-2 and HMGCR were significantly up-regulated by equol and genistein.
","[{'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Dou', 'Affiliation': 'School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Gonglie', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Institute of Cardiovascular Research, Peking University, Key Laboratory of Molecular Cardiology, Ministry of Education, Beijing 100191, China.'}, {'ForeName': 'Yuanfa', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Institute of Cardiovascular Research, Peking University, Key Laboratory of Molecular Cardiology, Ministry of Education, Beijing 100191, China.'}, {'ForeName': 'Zekun', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Institute of Cardiovascular Research, Peking University, Key Laboratory of Molecular Cardiology, Ministry of Education, Beijing 100191, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Institute of Cardiovascular Research, Peking University, Key Laboratory of Molecular Cardiology, Ministry of Education, Beijing 100191, China.'}, {'ForeName': 'Defu', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'School of Public Health, Peking University, Beijing 100191, China.'}]",Wei sheng yan jiu = Journal of hygiene research,['10.19813/j.cnki.weishengyanjiu.2021.05.012']
2441,34749826,Effectiveness of a health promotion intervention to address determinants of child neglect in a disadvantaged community in Sri Lanka.,"BACKGROUND


Child neglect is a form of child maltreatment and it is a neglected area of research. As similar to other forms of maltreatment, neglect also results in negative health outcomes for children. Child neglect is concentrated in disadvantaged communities. The community-centered health promotion approach empowers communities to identify and address determinants of perceived health issues. This study aimed to implement a health promotion intervention to enable a disadvantaged community to address determinants of child neglect and evaluate the effectiveness of the intervention.
METHODS


A quasi-experimental study design was used. Two disadvantaged communities in Anuradhapura District, Sri Lanka with similar socio-demographic characteristics were purposively selected as the experimental and control study settings. The mothers who have at least one child in the age range 5-18 years were included in the sample. The sample included 42 mothers from the experimental group and 44 mothers from the control group. The elder children of mothers in the experimental group were selected to be the agents of change. A health promotion intervention was implemented only with the experimental setting. The steps of the intervention included; (1) identifying prevention of child neglect as a goal, (2) understanding the determinants, (3) analyzing determinants and identifying actions and (4) implementing and modifying the actions. The total study duration was 1 year, with the intervention taking an average of 6 months. Data were collected at both pre and post-intervention phases from mothers and children through interviewer-administered questionnaires.
RESULTS


Mothers of the experimental group improved their knowledge on child neglect significantly in comparison to the control group (p < 0.05). In the post-intervention phase, there were significant differences in attitudes related to child neglect between experimental and control groups (p < 0.05). Following the health promotion intervention, mothers of the experimental group had significantly improved their practices related to the safety, education, nutrition of children, relationships with the child and social support for child caring (p < 0.05) when compared with the control group.
CONCLUSIONS


The health promotion intervention was effective in addressing the selected determinants of child neglect in a disadvantaged community. Children could act as active agents of change to deliver the interventions to their mothers (perpetrators).",2021,"RESULTS


Mothers of the experimental group improved their knowledge on child neglect significantly in comparison to the control group (p < 0.05).","['Two disadvantaged communities in Anuradhapura District, Sri Lanka with similar socio-demographic characteristics', '42 mothers from the experimental group and 44 mothers from the control group', 'mothers who have at least one child in the age range 5-18\xa0years were included in the sample', 'child neglect in a disadvantaged community in Sri Lanka', 'children']",['health promotion intervention'],"['knowledge on child neglect', 'safety, education, nutrition of children, relationships with the child and social support for child caring', 'attitudes related to child neglect']","[{'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0553726', 'cui_str': 'Victim of child neglect'}]","[{'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0553726', 'cui_str': 'Victim of child neglect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",42.0,0.0102492,"RESULTS


Mothers of the experimental group improved their knowledge on child neglect significantly in comparison to the control group (p < 0.05).","[{'ForeName': 'Nadeeka', 'Initials': 'N', 'LastName': 'Rathnayake', 'Affiliation': 'Department of Health Promotion, Faculty of Applied Sciences, Rajarata University of Sri Lanka, Mihintale, Sri Lanka. nadeeka93rathnayake@gmail.com.'}, {'ForeName': 'Shreenika', 'Initials': 'S', 'LastName': 'De Silva Weliange', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'G N Duminda', 'Initials': 'GND', 'LastName': 'Guruge', 'Affiliation': 'Department of Health Promotion, Faculty of Applied Sciences, Rajarata University of Sri Lanka, Mihintale, Sri Lanka.'}]","Journal of health, population, and nutrition",['10.1186/s41043-021-00267-6']
2442,34749823,Is an individually tailored programme of intense leg resistance and dynamic exercise acceptable to adults with an acute lateral patellar dislocation? A feasibility study.,"BACKGROUND


Lateral patellar dislocations mainly affect active teenagers and young adults. To help people recover, non-surgical exercise-based treatment is often recommended but the optimal exercise-based treatment is unknown. Currently, treatment outcomes after this injury are variable. Common problems include recurrent dislocation, reduced activity levels, and later surgery. A programme of intense leg resistance exercises, and dynamic exercises related to participants' activity-related goals, has rationale, but has not been previously reported. In line with the Medical Research Council guidance, this study aimed to assess the acceptability of a novel evidence-based exercise programme for adults after acute lateral patellar dislocation and the feasibility of future research evaluating this treatment.
METHODS


A single-group prospective study was conducted at the John Radcliffe Hospital, Oxford, UK. Participants were 16 years or older with an acute first-time or recurrent lateral patellar dislocation. Participants received up to six face-to-face, one-to-one, physiotherapy sessions, over a maximum of 3 months, and performed intensive home exercises independently at least three times per week. Strategies to increase exercise adherence were used. Primary objectives were to determine the number of eligible patients, the recruitment rate (proportion of eligible patients that provided written informed consent), participant adherence to scheduled physiotherapy sessions and self-reported adherence to prescribed exercise, and intervention acceptability to participants measured by attrition and a study-specific questionnaire. Data were analysed using descriptive statistics.
RESULTS


Fifteen of 22 (68%) patients with a lateral patellar dislocation were eligible. All eligible (100%) were recruited. Two of 15 (13%) participants provided no outcome data, 2/15 (13%) provided partial outcome data, and 11/15 (73%) provided all outcome data. Questionnaire responses demonstrated high intervention acceptability to participants. Participants attended 56/66 (85%) physiotherapy sessions and 10/11 (91%) participants reported they 'always' or 'often' completed the prescribed exercise. One participant redislocated their patella; another experienced knee pain or swelling lasting more than one week after home exercise on three occasions.
CONCLUSION


The intervention appeared acceptable to adults after acute lateral patellar dislocation, and a future randomised pilot trial is feasible. This future pilot trial should estimate attrition with increased precision over a longer duration and assess participants' willingness to be randomised to different treatments across multiple centres.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03798483 , registered on January 10, 2019.",2021,Questionnaire responses demonstrated high intervention acceptability to participants.,"['Participants were 16 years or older with an acute first-time or recurrent lateral patellar dislocation', 'adults after acute lateral patellar dislocation', 'All eligible (100%) were recruited', 'Fifteen of 22 (68', ""Participants attended 56/66 (85%) physiotherapy sessions and 10/11 (91%) participants reported they 'always' or 'often' completed the prescribed exercise"", 'patients with a lateral patellar dislocation were eligible', 'active teenagers and young adults', 'adults with an acute lateral patellar dislocation']",['novel evidence-based exercise programme'],"['exercise adherence', 'recurrent dislocation, reduced activity levels, and later surgery', 'participant adherence to scheduled physiotherapy sessions and self-reported adherence to prescribed exercise, and intervention acceptability', 'knee pain or swelling lasting']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1135812', 'cui_str': 'Dislocation of patellofemoral joint'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0158100', 'cui_str': 'Recurrent dislocation of joint'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}]",,0.0667091,Questionnaire responses demonstrated high intervention acceptability to participants.,"[{'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Forde', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Kadoorie Research Centre, University of Oxford, Kadoorie Centre for Critical Care Research and Education, Level 3, John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK. colin.forde@ndorms.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Haddad', 'Affiliation': 'School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'Shashivadan P', 'Initials': 'SP', 'LastName': 'Hirani', 'Affiliation': 'School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Keene', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Kadoorie Research Centre, University of Oxford, Kadoorie Centre for Critical Care Research and Education, Level 3, John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00932-x']
2443,34749822,Study protocol for a pilot high-intensity interval training intervention in inpatient mental health settings: a two-part study using a randomised controlled trial and naturalistic study design.,"BACKGROUND


Severe mental illnesses (SMI), including schizophrenia spectrum disorder, bipolar disorder and major depressive disorder, are associated with physical health comorbidities and premature mortality. Physical activity and structured exercise have a beneficial impact on cardiometabolic risk and ameliorate mental health symptomology and cognition. This protocol describes a feasibility study for a high-intensity interval training (HIIT) intervention among inpatients with SMI, to improve their physical and mental health.
METHODS


The feasibility study follows a two-part design owing to COVID-19-related adaptations to project design: (a) a non-blinded randomised controlled trial (RCT) of 12 weeks of bicycle-based HIIT, delivered twice weekly in a face-to-face, one-to-one setting, compared to treatment as usual (TAU) and (b) a naturalistic study of inpatient HIIT; eligible participants will be invited to two sessions of HIIT per week, delivered by the research team remotely or in person. Additionally, participants in the naturalistic study may use the bike to conduct self-directed sessions of their chosen length and intensity. We will measure the feasibility and acceptability of the HIIT intervention as primary outcomes, alongside secondary and tertiary outcomes evaluating the physical, mental and cognitive effects of HIIT. The study aims to recruit 40 patients to the RCT and 6-8 patients to the naturalistic design.
DISCUSSION


Exercise is a modifiable lifestyle barrier that can reverse cardiometabolic disease risk. If HIIT is found to be feasible and acceptable in inpatients with SMI, there would be scope for large-scale work to evaluate the clinical, cost and implementation effectiveness of HIIT in inpatient mental health settings.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03959735 . Registered June 22, 2019.",2021,Physical activity and structured exercise have a beneficial impact on cardiometabolic risk and ameliorate mental health symptomology and cognition.,"['inpatients with SMI, to improve their physical and mental health', 'inpatients with SMI', 'inpatient mental health settings', '40 patients to the RCT and 6-8 patients to the naturalistic design']","['HIIT intervention', 'high-intensity interval training (HIIT) intervention', 'pilot high-intensity interval training intervention', 'Physical activity and structured exercise']",[],"[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.063063,Physical activity and structured exercise have a beneficial impact on cardiometabolic risk and ameliorate mental health symptomology and cognition.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Martland', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK. rebecca.martland@kcl.ac.uk.""}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Onwumere', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Stubbs', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Gaughran', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK.""}]",Pilot and feasibility studies,['10.1186/s40814-021-00937-6']
2444,34749821,Impact of Spirulina corn soy blend on Iron deficient children aged 6-23 months in Ndhiwa Sub-County Kenya: a randomized controlled trial.,"BACKGROUND


Iron deficiency anemia (IDA) remains high in Kenya despite interventions. Twenty-seven percent of children aged 6 months-14 years are anemic, with low iron intake (7%) among children aged 6-23 months. Standard food interventions involve a corn soy blend (CSB), which is limited in micronutrients, and fortifiers are not accessible locally. Moreover, the use of spirulina as a strategy for mitigating IDA has not been adequately documented. This study compared the impact of a spirulina corn soy blend (SCSB) on IDA among children aged 6-23 months.
METHODS


A total of 240 children with IDA were randomly assigned to study groups at a ratio of 1:1:1 through lotteries, and caregivers and research assistants were blinded to group assignment. Dry-take-home SCSB, CSB and placebo flour (1.7 kg) was given to caregivers to prepare porridges using a flour water ratio of 1:4, producing 600 ml-700 ml of porridge to feed children 200 ml of porridge three times a day for 6 months. Impact was assessed as plasma hematocrit at baseline and after the study. Blood drawing, preparation and analysis were performed in accordance with approved procedures by the EthicsResearchCommittee. Monthly follow-up and data collection on dietary intake, anthropometry, morbidity and infant feeding practices were performed using questionnaires. Relative risk, magnitude of change and log-rank tests were used to compare the impact of the intervention, and significant differences were determined at P < 0.05.
RESULTS


The survival probabilities for children consuming SCSB were significantly higher than those consuming CSB (log-rank-X 2  = 0.978; CI: 0.954-1.033, P = 0.001) and the placebo (log-rankX2 = 0.971; CI: 0.943-0.984, P = 0.0001). Children consuming SCSB had a mean recovery time of 8 days (CI: 7-12 days) compared to those consuming CSB (19 days; CI: 20-23 days) and placebo (33 days; CI: 3 1-35 days). The recovery rate was 15.4 per 100 persons per day for children who consumed SCSB as opposed to 4.6 and 1.8 per 100 persons per day for those who consumed CSB and the placebo, respectively.
CONCLUSION


Management of IDA with SCSB compared to CSB and the placebo led to faster reversal and large numbers of recoveries from IDA. The recovery rates were above the World Health Organizations (WHO) minimums standards for food interventions. Efforts to realize high and faster recoveries from IDA should be heightened by fortifying CSB with spirulina powder.",2021,"The survival probabilities for children consuming SCSB were significantly higher than those consuming CSB (log-rank-X 2  = 0.978; CI: 0.954-1.033, P = 0.001) and the placebo (log-rankX2 = 0.971; CI: 0.943-0.984, P = 0.0001).","['240 children with IDA', 'Iron deficient children aged 6-23\u2009months in Ndhiwa Sub-County Kenya', 'Twenty-seven percent of children aged 6\u2009months-14\u2009years are anemic, with low iron intake (7%) among children aged 6-23\u2009months', 'children aged 6-23\u2009months']","['spirulina corn soy blend (SCSB', 'Dry-take-home SCSB, CSB and placebo flour', 'Spirulina corn soy blend', 'corn soy blend (CSB', 'placebo']","['recovery rates', 'recovery rate', 'plasma hematocrit', 'survival probabilities', 'mean recovery time', 'dietary intake, anthropometry, morbidity and infant feeding practices']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0860975', 'cui_str': 'Iron low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0075026', 'cui_str': 'Spirulina'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016260', 'cui_str': 'Flour'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",240.0,0.205323,"The survival probabilities for children consuming SCSB were significantly higher than those consuming CSB (log-rank-X 2  = 0.978; CI: 0.954-1.033, P = 0.001) and the placebo (log-rankX2 = 0.971; CI: 0.943-0.984, P = 0.0001).","[{'ForeName': 'Dorothy Apondi', 'Initials': 'DA', 'LastName': 'Othoo', 'Affiliation': 'Jomo Kenyatta University of Agriculture and Technology, P.O.Box 62000-00200, Nairobi, Kenya. othoodapa@gmail.com.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Ochola', 'Affiliation': 'Kenyatta University, P.O. Box 43844-00100, Nairobi, Kenya.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kuria', 'Affiliation': 'Kenyatta University, P.O. Box 43844-00100, Nairobi, Kenya.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kimiywe', 'Affiliation': 'Kenyatta University, P.O. Box 43844-00100, Nairobi, Kenya.'}]",BMC nutrition,['10.1186/s40795-021-00472-w']
2445,34749808,Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study.,"BACKGROUND


Bone grafting is an important surgical procedure to reconstruct alveolar bone defects in patients with cleft lip and palate. Polyphosphate (PolyP) is a physiological polymer present in the blood, primarily in platelets. PolyP plays a role as a phosphate source in bone calcium phosphate deposition. Moreover, the cleavage of high-energy bonds to release phosphates provides local energy necessary for regenerative processes. In this study, polyP is complexed with calcium to form Calcium polyP microparticles (Ca-polyP MPs), which were shown to have osteoinductive properties in preclinical studies. The aim of this study was to evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs, alone or in combination with BCP, in a first-in-human clinical trial.
METHODS


This single-blinded, parallel, prospective clinical pilot study enrolled eight adolescent patients (mean age 18.1: range 13-34 years) with residual alveolar bone cleft. Randomization in two groups (four receiving Ca-polyP MPs only, four a combination of Ca-polyP MPs and biphasic calcium phosphate (BCP)) was performed. Patient follow-up was 6 months. Outcome parameters included safety parameters and close monitoring of possible adverse effects using radiographic imaging, regular blood tests, and physical examinations. Osteoinductivity evaluation using histomorphometric analysis of biopsies was not possible due to COVID restrictions.
RESULTS


Due to surgical and feasibility reasons, eventually, only 2 patients received Ca-polyP MPs, and the others the combination graft. All patients were assessed up to day 90. Four out of eight were able to continue with the final assessment day (day 180). Three out of eight were unable to reach the hospital due to COVID-19 restrictions. One patient decided not to continue with the study. None of the patients showed any allergic reactions or any remarkable local or systematic side effects. Radiographically, patients receiving Ca-polyP MPs only were scored grade IV Bergland scale, while patients who got the BCP/Ca-polyP MPs combination had scores ranging from I to III.
CONCLUSIONS


Our results indicate that Ca-polyP MPs and the BCP/Ca-polyP MPs combination appear to be safe graft materials; however, in the current setting, Ca-polyP MPs alone may not be a sufficiently stable defect-filling scaffold to be used in alveolar cleft repair.
TRIAL REGISTRATION


Indonesian Trial Registry under number INA-EW74C1N by the ethical committee of Faculty of Medicine, Hasanuddin University, Makassar, Indonesia with code number 1063/UN4.6.4.5.31/PP36/2019 .",2021,None of the patients showed any allergic reactions or any remarkable local or systematic side effects.,"['alveolar cleft repair', 'patients with cleft lip and palate', 'enrolled eight adolescent patients (mean age 18.1: range 13-34 years) with residual alveolar bone cleft']","['polyphosphate (PolyP', 'Ca-polyP MPs and biphasic calcium phosphate (BCP', 'Polyphosphate (PolyP', 'Ca-polyP MPs, alone or in combination with BCP']","['safety parameters and close monitoring of possible adverse effects using radiographic imaging, regular blood tests, and physical examinations', 'grade IV Bergland scale', 'allergic reactions']","[{'cui': 'C0432084', 'cui_str': 'Cleft of primary palate'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0158646', 'cui_str': 'Cleft palate with cleft lip'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}]","[{'cui': 'C0032575', 'cui_str': 'Polyphosphates'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0210087', 'cui_str': 'hydroxyapatite-beta tricalcium phosphate'}, {'cui': 'C0053051', 'cui_str': 'BCP protocol'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0457276', 'cui_str': 'Radiographic imaging - action'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",8.0,0.047801,None of the patients showed any allergic reactions or any remarkable local or systematic side effects.,"[{'ForeName': 'Salem A', 'Initials': 'SA', 'LastName': 'Alkaabi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands. al_kaabi33@hotmail.com.'}, {'ForeName': 'Diandra Sabrina Natsir', 'Initials': 'DSN', 'LastName': 'Kalla', 'Affiliation': 'Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Ghamdan A', 'Initials': 'GA', 'LastName': 'Alsabri', 'Affiliation': 'Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Abul', 'Initials': 'A', 'LastName': 'Fauzi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Nova', 'Initials': 'N', 'LastName': 'Jansen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Tajrin', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Rifaat', 'Initials': 'R', 'LastName': 'Nurrahma', 'Affiliation': 'Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Müller', 'Affiliation': 'Institute for Physiological Chemistry, University Medical Center, University Mainz, Mainz, Germany.'}, {'ForeName': 'Heinz C', 'Initials': 'HC', 'LastName': 'Schröder', 'Affiliation': 'Institute for Physiological Chemistry, University Medical Center, University Mainz, Mainz, Germany.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Xiaohong', 'Affiliation': 'Institute for Physiological Chemistry, University Medical Center, University Mainz, Mainz, Germany.'}, {'ForeName': 'Tymour', 'Initials': 'T', 'LastName': 'Forouzanfar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Marco N', 'Initials': 'MN', 'LastName': 'Helder', 'Affiliation': 'Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Ruslin', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia. mruslin@unhas.ac.id.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00939-4']
2446,34749788,HOME DM-BAT: home-based diabetes-modified behavioral activation treatment for low-income seniors with type 2 diabetes-study protocol for a randomized controlled trial.,"BACKGROUND


About 13% of African Americans and 13% of Hispanics have diabetes, compared to 8% of non-Hispanic Whites (NHWs). This is more pronounced in the elderly where about 25-30% of those aged 65 and older have diabetes. Studies have found associations between social determinants of health (SDoH) and increased incidence, prevalence, and burden of diabetes; however, few interventions have accounted for the context in which the elderly live by addressing SDoH. Specifically, psychosocial factors (such as cognitive dysfunction, functional impairment, and social isolation) impacting this population may be under-addressed due to numerous medical concerns addressed during the clinical visit. The long-term goal of the project is to identify strategies to improve glycemic control and reduce diabetes complications and mortality in African Americans and Hispanics/Latinos with type 2 diabetes.
METHODS


This is a 5-year prospective, randomized clinical trial, which will test the effectiveness of a home-based diabetes-modified behavioral activation treatment for low-income, minority seniors with type 2 diabetes mellitus (T2DM) (HOME DM-BAT). Two hundred, aged 65 and older and with an HbA1c ≥8%, will be randomized into one of two groups: (1) an intervention using in-home, nurse telephone-delivered diabetes education, and behavioral activation or (2) a usual care group using in-home, nurse telephone-delivered, health education/supportive therapy. Participants will be followed for 12 months to ascertain the effect of the intervention on glycemic control, blood pressure, and low-density lipoprotein (LDL) cholesterol. The primary hypothesis is low-income, minority seniors with poorly controlled type 2 diabetes randomized to HOME DM-BAT will have significantly greater improvements in clinical outcomes at 12 months of follow-up compared to usual care.
DISCUSSION


Results from this study will provide important insight into the effectiveness of a home-based diabetes-modified behavioral activation treatment for low-income, minority seniors with uncontrolled type 2 diabetes mellitus and inform strategies to improve glycemic control and reduce diabetes complications in minority elderly with T2DM.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04203147 ). Registered on December 18, 2019, with the National Institutes of Health Clinical Trials Registry.",2021,"Studies have found associations between social determinants of health (SDoH) and increased incidence, prevalence, and burden of diabetes; however, few interventions have accounted for the context in which the elderly live by addressing SDoH.","['minority elderly with T2DM', 'Two hundred, aged 65 and older and with an HbA1c ≥8', 'low-income, minority seniors with type 2 diabetes mellitus (T2DM) (HOME DM-BAT', 'African Americans and Hispanics/Latinos with type 2 diabetes', 'low-income seniors with type 2 diabetes', 'elderly where about 25-30% of those aged 65 and older have diabetes']","['HOME DM-BAT: home-based diabetes-modified behavioral activation treatment', 'HOME DM-BAT', 'intervention using in-home, nurse telephone-delivered diabetes education, and behavioral activation or (2) a usual care group using in-home, nurse telephone-delivered, health education/supportive therapy', 'home-based diabetes-modified behavioral activation treatment']","['glycemic control, blood pressure, and low-density lipoprotein (LDL) cholesterol']","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",,0.051087,"Studies have found associations between social determinants of health (SDoH) and increased incidence, prevalence, and burden of diabetes; however, few interventions have accounted for the context in which the elderly live by addressing SDoH.","[{'ForeName': 'Leonard E', 'Initials': 'LE', 'LastName': 'Egede', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA. legede@mcw.edu.'}, {'ForeName': 'Tatiana M', 'Initials': 'TM', 'LastName': 'Davidson', 'Affiliation': 'College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St, MSC 160, Charleston, SC, 29425, USA.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Knapp', 'Affiliation': 'Department of Public Health Services, College of Medicine, Medical University of South Carolina, 135 Cannon St., Charleston, SC, 29425, USA.'}, {'ForeName': 'Rebekah J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Joni S', 'Initials': 'JS', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Clara E', 'Initials': 'CE', 'LastName': 'Dismuke', 'Affiliation': 'Health Economics Resource Center, VA Palo Alto Healthcare System, 795 Willow Road (152 MPD), Menlo Park, CA, 94025, USA.'}, {'ForeName': 'Aprill Z', 'Initials': 'AZ', 'LastName': 'Dawson', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}]",Trials,['10.1186/s13063-021-05744-1']
2447,34749784,Measuring the effects of nurse practitioner (NP)-led care on depression and anxiety levels in people with multiple sclerosis: a study protocol for a randomized controlled trial.,"BACKGROUND


Canada has one of the highest rates of multiple sclerosis (MS) in the world. Treatments and supports for people with MS (PwMS) have become increasingly complex, requiring individualized and adaptive care. Specialized NPs provide advanced skills to those with complex medical conditions, with potential to enhance the health, functioning, and quality of life for PwMS. This study aims to determine the effect of a Nurse Practitioner (NP) on depression and anxiety levels in PwMS.
METHODS


We will perform a parallel randomized controlled trial. PwMS who are followed by general private-practice neurologists will be randomly assigned to the intervention group (NP-led care) or the 'usual care' control group (general neurologist or family physician and registered nurse support). In the intervention group, the NP will assess and provide care to the MS patient and their caregiver at a baseline visit, with 3-month and 6-month follow-up visits. PwMS in the control group will receive usual care provided by their community neurologists or family physicians with the standard assistance provided by registered nurses experienced in MS care. The primary outcome will be the difference in change in the patient's anxiety and depression scores as measured by the validated Hospital Anxiety and Depression Scale (HADS) questionnaire at 3 months. Secondary outcomes will include difference in change in HADS at 6 months; Modified Fatigue Impact Scale scores (MSIF) at 3 and 6 months; EQ-5D scores at 3 and 6 months; caregiver health-related quality of life in MS measures (CAREQOL-MS) at 3 and 6 months; number of visits and phone calls to healthcare professionals recorded by patient, and satisfaction with NP-led care vs usual care measured by the validated Consultant Satisfaction Questionnaire.
DISCUSSION


Findings from this study will contribute to exploring benefits of advanced nursing practitioner interventions for PwMS followed by general neurologists and family physicians in a community setting. It will provide evidence of the benefits of NP-led care for PwMS and offer an alternative healthcare resource for management of MS.
TRIAL REGISTRATION


ClinicalTrials.gov Pro00069595 . Retrospectively registered on June 26, 2020. Protocol version: January 2017, version 1.",2021,"Secondary outcomes will include difference in change in HADS at 6 months; Modified Fatigue Impact Scale scores (MSIF) at 3 and 6 months; EQ-5D scores at 3 and 6 months; caregiver health-related quality of life in MS measures (CAREQOL-MS) at 3 and 6 months; number of visits and phone calls to healthcare professionals recorded by patient, and satisfaction with NP-led care vs usual care measured by the validated Consultant Satisfaction Questionnaire.
","['people with MS (PwMS', 'PwMS who are followed by general private-practice neurologists', 'people with multiple sclerosis']","['nurse practitioner (NP)-led care', 'Nurse Practitioner (NP', 'Protocol version', ""intervention group (NP-led care) or the 'usual care' control group (general neurologist or family physician and registered nurse support""]","['number of visits and phone calls to healthcare professionals recorded by patient, and satisfaction with NP-led care vs usual care measured by the validated Consultant Satisfaction Questionnaire', 'depression and anxiety levels', ""patient's anxiety and depression scores"", 'validated Hospital Anxiety and Depression Scale (HADS) questionnaire', 'change in HADS at 6\u2009months; Modified Fatigue Impact Scale scores (MSIF) at 3 and 6\u2009months; EQ-5D scores at 3 and 6\u2009months; caregiver health-related quality of life in MS measures (CAREQOL-MS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}]","[{'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2960438', 'cui_str': 'Fatigue impact scale score'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]",,0.0766574,"Secondary outcomes will include difference in change in HADS at 6 months; Modified Fatigue Impact Scale scores (MSIF) at 3 and 6 months; EQ-5D scores at 3 and 6 months; caregiver health-related quality of life in MS measures (CAREQOL-MS) at 3 and 6 months; number of visits and phone calls to healthcare professionals recorded by patient, and satisfaction with NP-led care vs usual care measured by the validated Consultant Satisfaction Questionnaire.
","[{'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Smyth', 'Affiliation': 'Department of Medicine (Neurology), University of Alberta, Edmonton, AB, Canada. smyth@ualberta.ca.'}, {'ForeName': 'Kaitlyn E', 'Initials': 'KE', 'LastName': 'Watson', 'Affiliation': 'EPICORE Centre, Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ross T', 'Initials': 'RT', 'LastName': 'Tsuyuki', 'Affiliation': 'EPICORE Centre, Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}]",Trials,['10.1186/s13063-021-05726-3']
2448,34749783,"Home-based Extended Rehabilitation for Older people (HERO): study protocol for an individually randomised controlled multi-centre trial to determine the clinical and cost-effectiveness of a home-based exercise intervention for older people with frailty as extended rehabilitation following acute illness or injury, including embedded process evaluation.","BACKGROUND


The majority of older people (> 65 years) in hospital have frailty and are at increased risk of readmission or death following discharge home. In the UK, following acute hospitalisation, around one third of older people with frailty are referred on for rehabilitation, termed 'intermediate care' services. Although this rehabilitation can reduce early readmission to hospital (< 30 days), recipients often do not feel ready to leave the service on discharge, suggesting possible incomplete recovery. Limited evidence suggests extended rehabilitation is of benefit in several conditions and there is preliminary evidence that progressive physical exercise can improve mobility and function for older people with frailty, and slow progression to disability. Our aim is to evaluate the effectiveness of the Home-based Older People's Exercise (HOPE) programme as extended rehabilitation for older people with frailty discharged home from hospital or intermediate care services after acute illness or injury.
METHODS


A multi-centre individually randomised controlled trial, to evaluate the clinical and cost-effectiveness of the HOPE programme. This individualised, graded and progressive 24-week exercise programme is delivered by NHS physiotherapy teams to people aged 65 and older with frailty, identified using the Clinical Frailty Scale, following discharge from acute hospitalisation and linked intermediate care rehabilitation pathways. The primary outcome is physical health-related quality of life, measured using the physical component summary score of the modified Short Form 36- item health questionnaire (SF36) at 12 months. Secondary outcomes include self-reported physical and mental health, functional independence, death, hospitalisations, care home admissions. Plans include health economic analyses and an embedded process evaluation.
DISCUSSION


This trial seeks to determine if extended rehabilitation, via the HOPE programme, can improve physical health-related quality of life for older people with frailty following acute hospitalisation. Results will improve awareness of the rehabilitation needs of older people with frailty, and provide evidence on the clinical and cost-effectiveness of the targeted exercise intervention. There is potential for considerable benefit for health and social care services through widespread implementation of trial findings if clinical and cost-effectiveness is demonstrated.
TRIAL REGISTRATION


ISRCTN 13927531 . Registered on April 19, 2017.",2021,"In the UK, following acute hospitalisation, around one third of older people with frailty are referred on for rehabilitation, termed 'intermediate care' services.","['older people with frailty as extended rehabilitation following acute illness or injury, including embedded process evaluation', 'older people with frailty following acute hospitalisation', 'Older people (HERO', 'people aged 65 and older with frailty, identified using the Clinical Frailty Scale, following discharge from acute hospitalisation and linked intermediate care rehabilitation pathways', 'older people with frailty discharged home from hospital or intermediate care services after acute illness or injury']","['NHS physiotherapy teams', 'Home-based Extended Rehabilitation', 'HOPE programme', 'home-based exercise intervention', '24-week exercise programme', ""Home-based Older People's Exercise (HOPE) programme""]","['self-reported physical and mental health, functional independence, death, hospitalisations, care home admissions', 'physical health-related quality of life, measured using the physical component summary score of the modified Short Form 36- item health questionnaire (SF36', 'physical health-related quality of life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0920218,"In the UK, following acute hospitalisation, around one third of older people with frailty are referred on for rehabilitation, termed 'intermediate care' services.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Prescott', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK. Matthew.Prescott@bthft.nhs.uk.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lilley-Kelly', 'Affiliation': 'Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Cundill', 'Affiliation': 'Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clarke', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Leeds Institute of Health Science, University of Leeds, based at: Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Drake', 'Affiliation': 'Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Leeds Institute of Health Science, University of Leeds, based at: Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Goodwin', 'Affiliation': 'Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Goodwin', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, EX1 2LU, UK.'}, {'ForeName': 'Abi J', 'Initials': 'AJ', 'LastName': 'Hall', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, EX1 2LU, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Holland', 'Affiliation': 'Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, EX1 2LU, UK.'}, {'ForeName': 'Silviya', 'Initials': 'S', 'LastName': 'Nikolova', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Wright', 'Affiliation': 'Physiotherapy Department, Bradford Teaching Hospitals NHS Foundation Trust, Bradford Royal Infirmary, Bradford, BD9 6RJ, UK.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Ziegler', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clegg', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Leeds Institute of Health Science, University of Leeds, based at: Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.'}]",Trials,['10.1186/s13063-021-05778-5']
2449,34749782,Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): study protocol for a randomized non-inferiority trial of magnetic seizure therapy versus electroconvulsive therapy.,"BACKGROUND


Electroconvulsive therapy (ECT) is well-established and effective for treatment-resistant depression (TRD), but in Canada and the USA, less than 1% of patients with TRD receive ECT mainly due to its cognitive adverse effects (i.e. amnesia). Thus, new treatment alternatives for TRD are urgently needed. One such treatment is magnetic seizure therapy (MST). ECT involves applying a train of high-frequency electrical stimuli to induce a seizure, whereas MST involves applying a train of high-frequency magnetic stimuli to induce a seizure.
METHODS


In this manuscript, we introduce our international, two-site, double-blinded, randomized, non-inferiority clinical trial to develop MST as an effective and safe treatment for TRD. This trial will compare the efficacy of MST to right unilateral ultra-brief pulse width electroconvulsive therapy (RUL-UB-ECT) with a combined primary endpoint of remission of depression and superior cognitive adverse effects in 260 patients with TRD. Amelioration of suicidal ideation will be assessed as a secondary endpoint. Inpatients or outpatients, over 18 years of age with a MINI International Neuropsychiatric Interview (MINI) diagnosis of non-psychotic major depressive disorder (MDD) can be enrolled in the study provided that they meet illness severity and full eligibility criteria. Participants are randomized to receive MST or RUL-UB ECT, 2-3 days per week over seven weeks, or a maximum of 21 treatments. The study will involve before-, during-, and after-treatment assessments of depression severity, suicidal ideation, subjective side-effects, and cognitive performance consistent with an intent-to-treat study design approach.
DISCUSSION


Positive results from this trial could have an immediate and tremendous impact for patients with TRD. If MST demonstrates comparable antidepressant treatment efficacy to ECT, but with greater cognitive safety, it could rapidly be adopted into clinical practice. Indeed, given that the administration of MST is nearly identical to ECT, the majority of ECT facilities in North America could readily adopt MST. Furthermore, the potential for cognitive safety could lead to improved treatment acceptability. Healthcare providers, patients and care partners, and policymakers would therefore demand this form of convulsive therapy.
TRIAL STATUS


Enrollment for this study began on June 26, 2018, and is estimated to complete recruitment by July 2024. At the time of submission, we have enrolled and randomized 117 participants.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03191058 , Registered on June 19, 2017. Primary sponsor: Daniel Blumberger (DMB), Principal Investigator Daniel.Blumberger@camh.ca , 416-535-8501 x 33662 Contact for public queries: DMB, Daniel.Blumberger@camh.ca Contact for scientific queries: ZJD, Zdaskalakis@health.ucsd.edu.",2021,"If MST demonstrates comparable antidepressant treatment efficacy to ECT, but with greater cognitive safety, it could rapidly be adopted into clinical practice.","['260 patients with TRD', 'patients with TRD', 'Enrollment for this study began on June 26, 2018, and is estimated to complete recruitment by July 2024', 'Depression', 'Inpatients or outpatients, over 18\u2009years of age with a MINI International Neuropsychiatric Interview (MINI) diagnosis of non-psychotic major depressive disorder (MDD']","['MST', 'Magnetic Seizure Therapy', 'Electroconvulsive therapy (ECT', 'magnetic seizure therapy', 'MST to right unilateral ultra-brief pulse width electroconvulsive therapy (RUL-UB-ECT', 'MST or RUL-UB ECT', 'CREST-MST', 'electroconvulsive therapy', 'ECT', 'magnetic seizure therapy (MST']","['remission of depression and superior cognitive adverse effects', 'cognitive safety', 'depression severity, suicidal ideation, subjective side-effects, and cognitive performance', 'suicidal ideation']","[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0444804', 'cui_str': 'Brief pulse'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C1261074', 'cui_str': 'Structure of upper lobe of right lung'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",117.0,0.247464,"If MST demonstrates comparable antidepressant treatment efficacy to ECT, but with greater cognitive safety, it could rapidly be adopted into clinical practice.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA. zdaskalakis@health.ucsd.edu.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Tamminga', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Alanah', 'Initials': 'A', 'LastName': 'Throop', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Palmer', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Department of Psychology, University at Buffalo, The State University of New York | SUNY Buffalo, Buffalo, USA.'}, {'ForeName': 'Faranak', 'Initials': 'F', 'LastName': 'Farzan', 'Affiliation': 'School of Mechatronic Systems Engineering, Simon Fraser University, Surrey, British Columbia, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's, Toronto, Ontario, Canada.""}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Institute of Medical Science and Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}]",Trials,['10.1186/s13063-021-05730-7']
2450,34749777,Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH).,"BACKGROUND


Nowadays, the main challenge of transplantation is the improvement of long-term care, aiming at reducing treatment-related complications and at decreasing rejection rates. Patients' adherence to both treatment and hygienic-dietary measures is mandatory to achieve these objectives. Adherence to immunosuppressive drugs is estimated to be only 70%. We hypothesized that the implementation of a personalized pharmaceutical plan (PPP) would increase adherence and therefore graft survival.
METHODS/DESIGN


This study is a stepped-wedge cluster randomized trial with transplantation units defining clusters. Twelve clusters from 10 university hospitals were recruited. All centres started on the same day in the control phase. Every 7 weeks, one centre will switch to the intervention phase and remain there until the end of inclusions. We plan to recruit 1716 kidney and/or liver transplant patients. The intervention phase consists in setting up the PPP: development of the patient's hospital and community pharmaceutical follow-up. In the hospital, the pharmacist will carry out drug reconciliation upon admission, daily pharmaceutical follow-up of prescriptions and pharmaceutical interviews with the patient in order to explain the modalities of taking immunosuppressive drugs and hygienic-dietary measures. After hospitalization, during the post-transplantation year, pharmaceutical meetings will take place, prior to medical consultations in order to check the patient's understanding of the prescription, his adherence, to remind them of hygienic-dietary measures and to look for adverse effects. The hospital pharmacist will also be in charge of establishing a close link with the community pharmacist (CP) and general practitioner, especially providing discharge medication reconciliation, an e-learning and a checklist. Moreover, prior to each pharmaceutical consultation, the hospital pharmacist will contact the CP to discuss patient adherence. The primary outcome is adherence to immunosuppressive treatments 1 year post-transplantation assessed by using the BAASIS questionnaire and the health insurance data from the national health data system. A medico-economic study will measure the efficiency of this plan.
DISCUSSION


GRePH aims to increase adherence of liver and/or kidney transplant patients to their immunosuppressive therapies in order to reduce transplant rejections. To this end, a new clinical pharmacy model, the PPP, will be set up in 10 university hospitals.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04295928 . Registered on 5 March 2020.",2021,"Nowadays, the main challenge of transplantation is the improvement of long-term care, aiming at reducing treatment-related complications and at decreasing rejection rates.","['Twelve clusters from 10 university hospitals were recruited', 'liver and/or kidney transplant patients', '1716 kidney and/or liver transplant patients', 'kidney or liver transplant patients', '10 university hospitals']",['personalized pharmaceutical plan (PPP'],['adherence to immunosuppressive treatments 1 year post-transplantation assessed by using the BAASIS questionnaire and the health insurance data from the national health data system'],"[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1622900', 'cui_str': 'Data Systems'}]",,0.11877,"Nowadays, the main challenge of transplantation is the improvement of long-term care, aiming at reducing treatment-related complications and at decreasing rejection rates.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pourrat', 'Affiliation': 'Pharmacy Department, Pharm D, Tours University Hospital, 2 boulevard Tonnelle, 37044, 09, Tours Cedex, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Berthy', 'Affiliation': 'Pharmacy Department, Pharm D, Tours University Hospital, 2 boulevard Tonnelle, 37044, 09, Tours Cedex, France. elise.berthy@gmail.com.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Dupuis', 'Affiliation': 'Biology-Pharmacy-Public Health Department, University Hospital of Poitiers, 2 rue de la 9 Milétrie, 86021, Poitiers Cedex, France.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Barbier', 'Affiliation': 'Digestive Surgery and Liver Transplantation, Tours University Hospital, Tours, France.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Buchler', 'Affiliation': 'Nephrology Department, Tours University Hospital, 2 boulevard Tonnelle, 37044, 09, Tours Cedex, France.'}, {'ForeName': 'Leslie Grammatico', 'Initials': 'LG', 'LastName': 'Guillon', 'Affiliation': 'Department of Medical Information, Epidemiology and Medical Economy, Tours University Hospital, Tours, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Monmousseau', 'Affiliation': 'Health-economic Evaluation Unit, University Hospital of Tours, Tours, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ruspini', 'Affiliation': 'Regional Union of Healthcare Professionals Pharmacists of the Greater East of France, 4 rue Piroux, Nancy, France.'}, {'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Salamé', 'Affiliation': 'Digestive Surgery and Liver Transplantation, Tours University Hospital, Tours, France.'}, {'ForeName': 'Solène Brunet', 'Initials': 'SB', 'LastName': 'Houdard', 'Affiliation': 'Health-economic Evaluation Unit, University Hospital of Tours, Tours, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'Université de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France.'}]",Trials,['10.1186/s13063-021-05749-w']
2451,34749770,"Impact of low-dose calcipotriol ointment on wound healing, pruritus and pain in patients with dystrophic epidermolysis bullosa: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Wound management is a critical factor when treating patients with the inherited skin fragility disease dystrophic epidermolysis bullosa (DEB). Due to genetic defects in structural proteins, skin and mucous epithelia are prone to blistering and chronic wounding upon minor trauma. Furthermore, these wounds are commonly associated with excessive pruritus and predispose to the development of life-threatening squamous cell carcinomas, underscoring the unmet need for new therapeutic options to improve wound healing in this patient cohort. Vitamin D3 is acknowledged to play an important role in wound healing by modulating different cellular processes that impact epidermal homeostasis and immune responses. In this study, we evaluate the safety and efficacy of low-dose calcipotriol, a vitamin D3 analogue, in promoting wound healing and reducing itch and pain in patients with DEB.
METHODS


Eligible DEB patients, aged ≥ 6 years and with a known mutation in the COL7A1 gene, were recruited to a placebo-controlled, randomized, double blind, cross-over phase II monocentric clinical trial. Patients were required to have at least two wounds with a minimum size of 6 cm 2  per wound. The primary objective was to evaluate efficacy of daily topical application of a 0.05 µg/g calcipotriol ointment in reducing wound size within a 4-week treatment regimen. Secondary objectives were to assess safety, as well as the impact of treatment on pruritus, pain, and bacterial wound colonization in these patients.
RESULTS


Six patients completed the clinical trial and were included into the final analysis. Topical low-dose calcipotriol treatment led to a significant reduction in wound area at day 14 compared to placebo (88.4% vs. 65.5%, P < 0.05). Patients also reported a significant reduction of pruritus with calcipotriol ointment compared to placebo over the entire course of the treatment as shown by itch scores of 3.16 vs 4.83 (P < 0.05) and 1.83 vs 5.52 (P < 0.0001) at days 14 and 28, respectively. Treatment with low-dose calcipotriol did not affect serum calcium levels and improved the species richness of the wound microbiome, albeit with no statistical significance.
CONCLUSIONS


Our results show that topical treatment with low-dose calcipotriol can accelerate wound closure and significantly reduces itch, and can be considered a safe and readily-available option to improve local wound care in DEB patients. Trial Registration EudraCT: 2016-001,967-35. Registered 28 June 2016, https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001967-35/AT.",2021,"Topical low-dose calcipotriol treatment led to a significant reduction in wound area at day 14 compared to placebo (88.4% vs. 65.5%, P < 0.05).","['patients with DEB', 'patients with dystrophic epidermolysis bullosa', '6\xa0years and with a known mutation in the COL7A1 gene', 'patients with the inherited skin fragility disease dystrophic epidermolysis bullosa (DEB', 'DEB patients', 'Patients were required to have at least two wounds with a minimum size of 6 cm 2  per wound', 'Eligible DEB patients, aged\u2009≥']","['low-dose calcipotriol, a vitamin D3 analogue', 'low-dose calcipotriol ointment', 'Topical low-dose calcipotriol', 'calcipotriol ointment', 'Vitamin D3', 'placebo']","['wound size', 'wound healing and reducing itch and pain', 'wound healing, pruritus and pain', 'pruritus', 'safety and efficacy', 'pruritus, pain, and bacterial wound colonization', 'serum calcium levels', 'wound area']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079294', 'cui_str': 'Dystrophic epidermolysis bullosa'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0241181', 'cui_str': 'Fragile skin'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.32585,"Topical low-dose calcipotriol treatment led to a significant reduction in wound area at day 14 compared to placebo (88.4% vs. 65.5%, P < 0.05).","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Guttmann-Gruber', 'Affiliation': 'EB House Austria, Research Program for Molecular Therapy of Genodermatoses, Department of Dermatology and Allergology, University Hospital of the Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Piñón Hofbauer', 'Affiliation': 'EB House Austria, Research Program for Molecular Therapy of Genodermatoses, Department of Dermatology and Allergology, University Hospital of the Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Tockner', 'Affiliation': 'EB House Austria, Research Program for Molecular Therapy of Genodermatoses, Department of Dermatology and Allergology, University Hospital of the Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Reichl', 'Affiliation': 'EB House Austria, Research Program for Molecular Therapy of Genodermatoses, Department of Dermatology and Allergology, University Hospital of the Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Klausegger', 'Affiliation': 'EB House Austria, Research Program for Molecular Therapy of Genodermatoses, Department of Dermatology and Allergology, University Hospital of the Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hofbauer', 'Affiliation': 'Landesapotheke Salzburg, Department of Production, Hospital Pharmacy, Salzburg, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wolkersdorfer', 'Affiliation': 'Landesapotheke Salzburg, Department of Production, Hospital Pharmacy, Salzburg, Austria.'}, {'ForeName': 'Khek-Chian', 'Initials': 'KC', 'LastName': 'Tham', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, 8A Biomedical Grove, Immunos #06-06, Singapore, Singapore.'}, {'ForeName': 'Seong Soo', 'Initials': 'SS', 'LastName': 'Lim', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, 8A Biomedical Grove, Immunos #06-06, Singapore, Singapore.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Common', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, 8A Biomedical Grove, Immunos #06-06, Singapore, Singapore.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Diem', 'Affiliation': 'EB House Austria, Outpatient Unit, Department of Dermatology and Allergology, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Ude-Schoder', 'Affiliation': 'EB House Austria, Outpatient Unit, Department of Dermatology and Allergology, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hitzl', 'Affiliation': 'Research Office Biostatistics, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lagler', 'Affiliation': 'Institute for Inborn Errors of Metabolism and Department of Pediatrics, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Reichelt', 'Affiliation': 'EB House Austria, Research Program for Molecular Therapy of Genodermatoses, Department of Dermatology and Allergology, University Hospital of the Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Johann W', 'Initials': 'JW', 'LastName': 'Bauer', 'Affiliation': 'EB House Austria, Research Program for Molecular Therapy of Genodermatoses, Department of Dermatology and Allergology, University Hospital of the Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Lang', 'Affiliation': 'Department of Dermatology and Allergology, University Hospital Salzburg, Paracelsus Medical University, Muellner-Hauptstrasse 48, 5020, Salzburg, Austria. r.lang@salk.at.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Laimer', 'Affiliation': 'EB House Austria, Research Program for Molecular Therapy of Genodermatoses, Department of Dermatology and Allergology, University Hospital of the Paracelsus Medical University, Salzburg, Austria. m.laimer@salk.at.'}]",Orphanet journal of rare diseases,['10.1186/s13023-021-02062-2']
2452,34749762,"A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial.","BACKGROUND


Targeted normoxia (SpO 2  90-96% or PaO 2  60-100 mmHg) may help to conserve oxygen and improve outcomes in critically ill patients by avoiding potentially harmful hyperoxia. However, the role of normoxia for critically ill trauma patients remains uncertain. The objective of this study is to describe the study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients (SAVE-O2) clinical trial.
METHODS


Design, setting, and participants: Protocol for a multicenter cluster randomized, stepped wedge implementation trial evaluating the effectiveness of a multimodal intervention to target normoxia in critically ill trauma patients at eight level 1 trauma centers in the USA. Each hospital will contribute pre-implementation (control) and post-implementation (intervention) data. All sites will begin in the control phase with usual care. When sites reach their randomly assigned time to transition, there will be a one-month training period, which does not contribute to data collection. Following the 1-month training period, the site will remain in the intervention phase for the duration of the trial.
MAIN OUTCOME MEASURES


The primary outcome will be supplemental oxygen-free days, defined as the number of days alive and not on supplemental oxygen. Secondary outcomes include in-hospital mortality to day 90, hospital-free days to day 90, ventilator-free days (VFD) to day 28, time to room air, Glasgow Outcome Score (GOS), and duration of time receiving supplemental oxygen.
DISCUSSION


SAVE-O2 will determine if a multimodal intervention to improve compliance with targeted normoxia will safely reduce the need for concentrated oxygen for critically injured trauma patients. These data will inform military stakeholders regarding oxygen requirements for critically injured warfighters, while reducing logistical burden in prolonged combat casualty care.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04534959 . Registered September 1, 2020.",2021,"Secondary outcomes include in-hospital mortality to day 90, hospital-free days to day 90, ventilator-free days (VFD) to day 28, time to room air, Glasgow Outcome Score (GOS), and duration of time receiving supplemental oxygen.
","['critically ill trauma patients', 'critically ill trauma patients at eight level 1 trauma centers in the USA', 'critically ill patients by avoiding potentially harmful hyperoxia', 'critically injured trauma patients', 'Design, setting, and participants', 'Critically Ill Trauma Patients (SAVE-O2) clinical trial']",['multimodal intervention'],"['supplemental oxygen-free days, defined as the number of days alive and not on supplemental oxygen', 'hospital mortality to day 90, hospital-free days to day 90, ventilator-free days (VFD) to day 28, time to room air, Glasgow Outcome Score (GOS), and duration of time receiving supplemental oxygen']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.384214,"Secondary outcomes include in-hospital mortality to day 90, hospital-free days to day 90, ventilator-free days (VFD) to day 28, time to room air, Glasgow Outcome Score (GOS), and duration of time receiving supplemental oxygen.
","[{'ForeName': 'Layne', 'Initials': 'L', 'LastName': 'Dylla', 'Affiliation': 'Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Douin', 'Affiliation': 'Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Anderson', 'Affiliation': 'Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Rice', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Conner L', 'Initials': 'CL', 'LastName': 'Jackson', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Vikhyat S', 'Initials': 'VS', 'LastName': 'Bebarta', 'Affiliation': 'Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Schauer', 'Affiliation': 'US Air Force 59th Medical Wing, Office of the Chief Scientist, JBSA, Lackland, San Antonio, TX, USA.'}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA. Adit.Ginde@cuanschutz.edu.'}]",Trials,['10.1186/s13063-021-05688-6']
2453,34749751,"Relationship between genetic polymorphism of drug transporters and the efficacy of Rosuvastatin, atorvastatin and simvastatin in patients with hyperlipidemia.","BACKGROUND


To determine the effect of genetic polymorphism of drug transporters on the efficacy of treatment with Rosuvastatin, Atorvastatin and Simvastatin in patients with hyperlipidemia.
METHODS


The study consists of 180 patients, aged 40-75 years, with hyperlipidemia. All patients were divided into two equal groups: patients with different SLCO1B1 (521CC, 521CT and 521TT) and MDR1 (3435CC, 3435TC and 3435TT) genotypes. Each group was divided into rosuvastatin-treated, atorvastatin-treated and simvastatin-treated subgroups. The lipid-lowering effect of statins was assessed by tracing changes in total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels.
RESULTS


The use of statins over a 4-month period led to substantial reductions in TC and LDL-C levels. The hypolipidemic effect of studied agents was seen in both groups. However, it was less pronounced in patients with 521CC genotype. No statistically significantly differences were found between carriers of 3435TT, 3435CT and 3435CC genotypes.
CONCLUSIONS


The lipid-lowering efficacy of rosuvastatin was higher compared to other two statins. Patients with SLCO1B1 521CC genotype are more likely to encounter a decrease in the hypolipidemic effect of statins. Such a risk should be considered when treating this category of patients. MDR1 polymorphism had no significant effect on statin efficacy.",2021,"No statistically significantly differences were found between carriers of 3435TT, 3435CT and 3435CC genotypes.
","['patients with hyperlipidemia', 'patients with 521CC genotype', '180 patients, aged 40-75\u2009years, with hyperlipidemia']","['rosuvastatin-treated, atorvastatin-treated and simvastatin-treated subgroups', 'Rosuvastatin, Atorvastatin and Simvastatin', 'rosuvastatin', 'SLCO1B1 (521CC, 521CT and 521TT) and MDR1 (3435CC, 3435TC and 3435TT) genotypes', 'Rosuvastatin, atorvastatin and simvastatin']","['total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels', 'hypolipidemic effect of statins', 'TC and LDL-C levels', 'hypolipidemic effect', 'statin efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",180.0,0.0118901,"No statistically significantly differences were found between carriers of 3435TT, 3435CT and 3435CC genotypes.
","[{'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Sivkov', 'Affiliation': 'N.V. Sklifosovsky Institute of Clinical Medicine, Department of Clinical Pharmacology and Propaedeutics of Internal Diseases, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation. andr_sivkov@rambler.ru.'}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Chernus', 'Affiliation': 'N.V. Sklifosovsky Institute of Clinical Medicine, Department of Polyclinical Therapy, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Gorenkov', 'Affiliation': 'Institute of Leadership and Health Management, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Sivkov', 'Affiliation': 'N.V. Sklifosovsky Institute of Clinical Medicine, Department of Clinical Pharmacology and Propaedeutics of Internal Diseases, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Sivkova', 'Affiliation': 'N.V. Sklifosovsky Institute of Clinical Medicine, Department of Polyclinical Therapy, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Savina', 'Affiliation': 'N.V. Sklifosovsky Institute of Clinical Medicine, Department of Polyclinical Therapy, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}]",Lipids in health and disease,['10.1186/s12944-021-01586-7']
2454,34749744,"""Prevention of opioid use disorder: the HOME (housing, opportunities, motivation and engagement) feasibility study"".","Young adults experiencing homelessness are at high risk of opioid and other substance use, poor mental health outcomes, exposure to trauma, and other risks. Providing access to stable housing has the potential to act as a powerful preventive intervention, but supportive housing programs have been studied most often among chronically homeless adults or adults with serious mental illness. The Housing First model, which does not precondition supportive housing on sobriety, may reduce drug use in homeless adults. In the present study, we piloted an adapted model of Housing First plus prevention services that was tailored to the needs of young adults (18-24 years) experiencing homelessness in the USA. Preventive services were added to the Housing First model and included youth-centered advocacy services, motivational interviewing, and HIV risk prevention services. This model was piloted in a single-arm study (n = 21) to assess the feasibility, acceptability, and initial efficacy of a Housing First model over a 6-month period in preparation for a larger randomized trial. We use repeated measures ANOVA to test for changes in alcohol and drug use (percent days of use; alcohol or drug use consequences), housing stability, social network support, and cognitive distortions over 6 months of follow-up. A total of 17 youth completed the study (85% retention), and a high proportion of youth were stably housed at 6-month follow-up. Participation in intervention services was high with an average of 13.57 sessions for advocacy, 1.33 for MI, and 0.76 for HIV prevention. Alcohol use did not change significantly over time. However, drug use, drug use consequences, and cognitive distortions, and the size of youths' social networks that were drug using individuals decreased significantly. The Housing First model appeared to be feasible to deliver, and youth engaged in the supportive intervention services. The study demonstrates the potential for an adapted Housing First model to be delivered to youth experiencing homelessness and may improve outcomes, opening the way for larger randomized trials of the intervention.",2021,"Participation in intervention services was high with an average of 13.57 sessions for advocacy, 1.33 for MI, and 0.76 for HIV prevention.","['young adults (18-24\xa0years) experiencing homelessness in the USA', 'A total of 17 youth completed the study (85% retention), and a high proportion of youth were stably housed at 6-month follow-up', 'homeless adults', 'chronically homeless adults or adults with serious mental illness', 'Young adults experiencing homelessness']",[],"['feasibility, acceptability, and initial efficacy', ""size of youths' social networks""]","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",,0.0108477,"Participation in intervention services was high with an average of 13.57 sessions for advocacy, 1.33 for MI, and 0.76 for HIV prevention.","[{'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Kelleher', 'Affiliation': 'Department of Human Sciences, College of Education and Human Ecology, The Ohio State University, 1787 Neil Ave, 130 Campbell Hall, Columbus, OH, 43201, USA. Kelly.kelleher@nationwidechildrens.org.'}, {'ForeName': 'Ruri', 'Initials': 'R', 'LastName': 'Famelia', 'Affiliation': ""Center for Child Health Equity and Outcomes Research, Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA.""}, {'ForeName': 'Tansel', 'Initials': 'T', 'LastName': 'Yilmazer', 'Affiliation': ""Center for Child Health Equity and Outcomes Research, Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA.""}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Mallory', 'Affiliation': ""Center for Child Health Equity and Outcomes Research, Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA.""}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': 'College of Nursing, The Ohio State University, Newton Hall, 1585 Neil Avenue, Columbus, OH, 43201, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Chavez', 'Affiliation': 'Department of Human Sciences, College of Education and Human Ecology, The Ohio State University, 1787 Neil Ave, 130 Campbell Hall, Columbus, OH, 43201, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Slesnick', 'Affiliation': ""Center for Child Health Equity and Outcomes Research, Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA.""}]",Harm reduction journal,['10.1186/s12954-021-00560-x']
2455,34749739,Interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART).,"BACKGROUND


Sarcoidosis is an inflammatory disease characterized by the formation of granulomas, which involve the heart in up to 25% of patients. Cardiac sarcoidosis can lead to life threatening arrhythmias and heart failure. While corticosteroids have been used as a treatment for over 50 years, they are associated with hypertension, diabetes, and weight gain, further increasing cardiovascular risk. Interleukin-1 (IL-1) is the prototypical proinflammatory cytokine that works to activate the nuclear transcription factor NF-kB, one of the targets of glucocorticoids. IL-1 also plays an important role also in the pathophysiology of heart disease including atherosclerosis, myocardial infarction, and myocarditis.
METHODS


Building on a network of research collaborators developed in the Cardiac Sarcoidosis Consortium, we will investigate the feasibility and tolerability of treatment of CS with anakinra at two National Institute of Health Clinical and Translational Science Award (CTSA) hubs with expertise in cardiac sarcoidosis. In this pilot study, up to 28 patients with cardiac sarcoidosis will be recruited to compare the administration of an IL-1 blocker, anakinra, 100 mg daily on top of standard of care versus standard of care only for 28 days and followed for 180 days. Utilizing surrogate endpoints of changes in systemic inflammatory biomarkers and cardiac imaging, we aim to determine whether IL-1 blockade with anakinra can combat systemic and cardiac inflammation in patients with cardiac sarcoidosis.
DISCUSSION


The current trial demonstrates an innovative collaborative approach to clinical trial development in a rare, understudied disease that disproportionately affects females and minorities. Trial Registration The trial was registered prospectively with ClinicalTrials.gov on July 12, 2019, identifier NCT04017936.",2021,"IL-1 also plays an important role also in the pathophysiology of heart disease including atherosclerosis, myocardial infarction, and myocarditis.
","['patients with cardiac sarcoidosis', '28 patients with cardiac sarcoidosis', 'cardiac sarcoidosis']","['Interleukin-1 blockade', 'IL-1 blocker, anakinra, 100\xa0mg daily on top of standard of care versus standard of care', 'Interleukin-1 (IL-1']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392077', 'cui_str': 'Cardiac sarcoidosis'}]","[{'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],28.0,0.333631,"IL-1 also plays an important role also in the pathophysiology of heart disease including atherosclerosis, myocardial infarction, and myocarditis.
","[{'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Kron', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, P.O. Box 980053, Richmond, VA, 23298-0053, USA. jordana.kron@vcuhealth.org.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Crawford', 'Affiliation': 'Cardiovascular Center, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Mihalick', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, P.O. Box 980053, Richmond, VA, 23298-0053, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Bogun', 'Affiliation': 'Cardiovascular Center, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Jordan', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, P.O. Box 980053, Richmond, VA, 23298-0053, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Koelling', 'Affiliation': 'Cardiovascular Center, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Huzaefah', 'Initials': 'H', 'LastName': 'Syed', 'Affiliation': 'Division of Rheumatology, Virginia Commonwealth University, Allergy, and Immunology, Richmond, VA, USA.'}, {'ForeName': 'Aamer', 'Initials': 'A', 'LastName': 'Syed', 'Affiliation': 'Division of Pulmonary and Critical Care, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Iden', 'Affiliation': 'Division of Pulmonary and Critical Care, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Polly', 'Affiliation': 'Division of Pulmonary and Critical Care, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Federmann', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, P.O. Box 980053, Richmond, VA, 23298-0053, USA.'}, {'ForeName': 'Kirsta', 'Initials': 'K', 'LastName': 'Bray', 'Affiliation': 'Cardiovascular Center, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Lathkar-Pradhan', 'Affiliation': 'Cardiovascular Center, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Jasti', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, P.O. Box 980053, Richmond, VA, 23298-0053, USA.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Rosenfeld', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Birnie', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Smallfield', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, P.O. Box 980053, Richmond, VA, 23298-0053, USA.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Alpha Berry', 'Initials': 'AB', 'LastName': 'Fowler', 'Affiliation': 'Division of Pulmonary and Critical Care, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Ladd', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, P.O. Box 980053, Richmond, VA, 23298-0053, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ellenbogen', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, P.O. Box 980053, Richmond, VA, 23298-0053, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Van Tassell', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, P.O. Box 980053, Richmond, VA, 23298-0053, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Gregory Hundley', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, P.O. Box 980053, Richmond, VA, 23298-0053, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, P.O. Box 980053, Richmond, VA, 23298-0053, USA.'}]",Journal of translational medicine,['10.1186/s12967-021-03130-8']
2456,34749735,Implementation of web-based open-source radiotherapy delineation software (WORDS) in organs at risk contouring training for newly qualified radiotherapists: quantitative comparison with conventional one-to-one coaching approach.,"BACKGROUND


Due to the role expansion of radiotherapists in dosimetric aspect, radiotherapists have taken up organs at risk (OARs) contouring work in many clinical settings. However, training of newly qualified radiotherapists in OARs contouring can be time consuming, it may also cause extra burden to experienced radiotherapists. As web-based open-source radiotherapy delineation software (WORDS) has become more readily available, it has provided a free and interactive alternative to conventional one-to-one coaching approach during OARs contouring training. The present study aims to evaluate the effectiveness of WORDS in training OARs contouring skills of newly qualified radiotherapists, compared to those trained by conventional one-to-one coaching approach.
METHODS


Nine newly qualified radiotherapists (licensed in 2017 - 2018) were enrolled to the conventional one-to-one coaching group (control group), while 11 newly qualified radiotherapists (licensed in 2019 - 2021) were assigned to WORDS training group (measured group). Ten OARs were selected to be contoured in this 3-phases quantitative study. Participants were required to undergo phase 1 OARs contouring in the beginning of the training session. Afterwards, conventional one-to-one training or WORDS training session was provided to participants according to their assigned group. Then the participants did phase 2 and 3 OARs contouring which were separated 1 week apart. Phase 1 - 3 OARs contouring aimed to demonstrate participants' pre-training OARs contouring ability, post-training OARs contouring ability and knowledge retention after one-week interval respectively using either training approach. To prevent bias, the computed tomography dataset for OARs contouring in each phase were different. Variations in the contouring scores for the selected OARs were evaluated between 3 phases using Kruskal-Wallis tests with Dunn tests for pairwise comparisons. Variations in the contouring scores between control and measured group in phase 1 - 3 contouring were analyzed using Wilcoxon signed-rank test. A p-value < 0.05 was considered to be statistically significant.
RESULTS


In both control group and measured group, significant improvement (p < 0.05) in phase 2 and 3 contouring scores have been observed comparing to phase 1 contouring scores. In comparison of contouring scores between control group and measured group, no significant differences (p > 0.05) were observed in all OARs between both groups.
CONCLUSIONS


The results in this study have demonstrated that the outcome of OARs contouring training using WORDS is comparable to the conventional training approach. In addition, WORDS can offer flexibility to newly qualified radiotherapists to practice OARs contouring at will, as well as reduce staff training burden of experienced radiotherapists.",2021,"In comparison of contouring scores between control group and measured group, no significant differences (p > 0.05) were observed in all OARs between both groups.
","['Nine newly qualified radiotherapists (licensed in 2017 - 2018) were enrolled to the conventional one-to-one coaching group (control group), while 11 newly qualified radiotherapists (licensed in 2019 - 2021']","['web-based open-source radiotherapy delineation software (WORDS', 'WORDS training']",[],"[{'cui': 'C0278604', 'cui_str': 'Radiation therapist'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],2021.0,0.0116269,"In comparison of contouring scores between control group and measured group, no significant differences (p > 0.05) were observed in all OARs between both groups.
","[{'ForeName': 'Adams Hei Long', 'Initials': 'AHL', 'LastName': 'Yuen', 'Affiliation': ""Oncology Centre, St. Teresa's Hospital, 327 Prince Edward Road, Hong Kong Special Administrative Region, China. yhladams@hotmail.com.""}, {'ForeName': 'Alex Kai Leung', 'Initials': 'AKL', 'LastName': 'Li', 'Affiliation': ""Oncology Centre, St. Teresa's Hospital, 327 Prince Edward Road, Hong Kong Special Administrative Region, China.""}, {'ForeName': 'Philip Chung Yin', 'Initials': 'PCY', 'LastName': 'Mak', 'Affiliation': ""Oncology Centre, St. Teresa's Hospital, 327 Prince Edward Road, Hong Kong Special Administrative Region, China.""}, {'ForeName': 'Hin Lap', 'Initials': 'HL', 'LastName': 'Leung', 'Affiliation': ""Oncology Centre, St. Teresa's Hospital, 327 Prince Edward Road, Hong Kong Special Administrative Region, China.""}]",BMC medical education,['10.1186/s12909-021-02992-2']
2457,34749724,Dental follicles promote soft tissue management in surgical exposure of labially impacted maxillary canine.,"BACKGROUND


The present study aimed to report a technically improved operation on the surgical exposure of labially impacted maxillary canine, elaborating the management of soft tissue to achieve better aesthetic results, and post-treatment periodontal health.
METHODS


Patients sought orthodontic treatment with unilateral labially impacted maxillary canines were selected in this study. The impacted teeth were assigned to the experimental group and contralateral unimpacted canines were assigned to the control group. The impacted canines were surgically exposed with dissected dental follicle (DF) stitching to muscle and mucosa surrounding the crowns. The gingival index (GI), probing depth (PD), the width of the keratinized gingiva (WKG), gingival scars (GS), bone loss (BL), and apical root resorption (ARR) were recorded after the removal of the fixed appliance. A two-sample t-test was used for independent samples for parametric variables.
RESULTS


A total of 24 patients with unilateral maxillary canine impaction were successfully treated. The outcomes of GI, WKG, GS, BL, and ARR did not indicate statistical significance between the experimental group and the control group.
CONCLUSIONS


The preservation of DF promotes soft tissue management in combined surgical and orthodontic treatment of labially impacted maxillary canine to achieve better periodontal status. Trial Registration Chinese Clinical Trial Registry ChiCTR2000029091, 2020-01-12.",2021,"The outcomes of GI, WKG, GS, BL, and ARR did not indicate statistical significance between the experimental group and the control group.
","['Patients sought orthodontic treatment with unilateral labially impacted maxillary canines', '24 patients with unilateral maxillary canine impaction', '2020-01-12', 'surgical exposure of labially impacted maxillary canine']",[],"['gingival index (GI), probing depth (PD), the width of the keratinized gingiva (WKG), gingival scars (GS), bone loss (BL), and apical root resorption (ARR', 'GI, WKG, GS, BL, and ARR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",[],"[{'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C1290638', 'cui_str': 'Resorption of apex of tooth root'}]",24.0,0.0317214,"The outcomes of GI, WKG, GS, BL, and ARR did not indicate statistical significance between the experimental group and the control group.
","[{'ForeName': 'Li-Ru', 'Initials': 'LR', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Oral Diseases, and National Clinical Research Center for Oral Diseases, and Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, #14 Third Section, Renmin Road South, 610041, Chengdu, China.'}, {'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Qi', 'Affiliation': 'State Key Laboratory of Oral Diseases, and National Clinical Research Center for Oral Diseases, and Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, #14 Third Section, Renmin Road South, 610041, Chengdu, China.'}, {'ForeName': 'Chong-Yun', 'Initials': 'CY', 'LastName': 'Bao', 'Affiliation': 'State Key Laboratory of Oral Diseases, and National Clinical Research Center for Oral Diseases, and Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, #14 Third Section, Renmin Road South, 610041, Chengdu, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'State Key Laboratory of Oral Diseases, and National Clinical Research Center for Oral Diseases, and Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, #14 Third Section, Renmin Road South, 610041, Chengdu, China. jianpancn@scu.edu.cn.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oral Diseases, and National Clinical Research Center for Oral Diseases, and Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, #14 Third Section, Renmin Road South, 610041, Chengdu, China. jssyliuxian@163.com.'}]",BMC oral health,['10.1186/s12903-021-01922-4']
2458,34749720,"Effects of health-promoting school strategy on dental plaque control and preventive behaviors in schoolchildren in high-caries, rural areas of Taiwan: a quasi-experimental design.","BACKGROUND


We evaluated the effects of health-promoting school (HPS) strategy on plaque control and behavior change in high-caries schoolchildren in Taitung, Taiwan.
METHODS


A quasi-experimental design was adopted; six intervention schools (intervention group [IG]) and six comparison schools (comparison group [CG]) were selected from elementary schools with higher-than-average caries rates (> 68%). The IG was selected using cluster sampling, and the CG was selected to match the IG. In total, the IG and CG groups included 166 and 174 children each. The selected schools implemented the HPS framework for 3 months in the 2019 academic year. An oral examination of dental plaque was administered, and a self-administered questionnaire regarding knowledge, attitude, self-efficacy, and behaviors was distributed at baseline and at 2-week follow-up. A linear and logistic regression model using generalized estimating equations (GEEs) was used to analyze the differences between baseline and the follow-up data.
RESULTS


Compared with the CG, the IG had a greater reduction in plaque index among second graders (β =  - 0.36) and plaque control record scores among second, fourth, and sixth graders (β =  - 27.48, - 26.04, and - 18.38, respectively). The IG also exhibited a greater increase at follow-up with respect to oral health-related knowledge among second graders and fourth graders (β = 1.46 and β = 0.92, respectively), attitude toward oral hygiene behaviors among sixth graders (β = 1.78), and self-efficacy regarding flossing for sixth graders (β = 1.43). Sixth graders in the IG were significantly more likely to brush before sleeping (adjusted odds ratio [aOR] = 2.99) and use fluoride toothpaste (aOR = 5.88) than those in the CG.
CONCLUSIONS


The HPS strategy was effective in reducing dental plaque and promoting preventing behaviors in rural high-caries schoolchildren.",2021,"The IG also exhibited a greater increase at follow-up with respect to oral health-related knowledge among second graders and fourth graders (β = 1.46 and β = 0.92, respectively), attitude toward oral hygiene behaviors among sixth graders (β = 1.78), and self-efficacy regarding flossing for sixth graders (β = 1.43).","['elementary schools with higher-than-average caries rates (>\u200968', 'rural high-caries schoolchildren', 'schoolchildren in high-caries, rural areas of Taiwan', 'high-caries schoolchildren in Taitung, Taiwan']","['fluoride toothpaste', 'health-promoting school strategy', 'health-promoting school (HPS) strategy', 'six intervention schools (intervention group [IG]) and six comparison schools (comparison group [CG']","['attitude toward oral hygiene behaviors', 'plaque index', 'dental plaque control and preventive behaviors']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}]",,0.0187227,"The IG also exhibited a greater increase at follow-up with respect to oral health-related knowledge among second graders and fourth graders (β = 1.46 and β = 0.92, respectively), attitude toward oral hygiene behaviors among sixth graders (β = 1.78), and self-efficacy regarding flossing for sixth graders (β = 1.43).","[{'ForeName': 'Chun-Ting', 'Initials': 'CT', 'LastName': 'Wei', 'Affiliation': 'Department of Oral Hygiene, College of Dental Medicine, Kaohsiung Medical University, 100 Shih-Chuan 1st Road, Sanmin Dist., Kaohsiung City, 80708, Taiwan.'}, {'ForeName': 'Kai-Yang', 'Initials': 'KY', 'LastName': 'Lo', 'Affiliation': 'Center for Physical and Health Education, National Sun Yat-Sen University, No. 70 Lien-hai Rd., Kaohsiung, 80424, Taiwan.'}, {'ForeName': 'Yi-Ching', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'School of Dentistry, College of Dental Medicine, Kaohsiung Medical University, 100 Shih-Chuan 1st Road, Sanmin Dist., Kaohsiung City, 80708, Taiwan.'}, {'ForeName': 'Chih-Yang', 'Initials': 'CY', 'LastName': 'Hu', 'Affiliation': 'School of Public Health, Health Sciences Center, Louisiana State University, 2020 Gravier Street, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Fu-Li', 'Initials': 'FL', 'LastName': 'Chen', 'Affiliation': 'Department of Public Health, Fu Jen Catholic University, No. 510, Zhongzheng Rd., Xinzhuang Dist., New Taipei City, 242062, Taiwan.'}, {'ForeName': 'Hsiao-Ling', 'Initials': 'HL', 'LastName': 'Huang', 'Affiliation': 'Department of Oral Hygiene, College of Dental Medicine, Kaohsiung Medical University, 100 Shih-Chuan 1st Road, Sanmin Dist., Kaohsiung City, 80708, Taiwan. hhuang@kmu.edu.tw.'}]",BMC oral health,['10.1186/s12903-021-01927-z']
2459,34749717,"SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout.","BACKGROUND


Urate-lowering therapy (ULT) adherence is low in gout, and few, if any, effective, low-cost, interventions are available. Our objective was to assess if a culturally appropriate gout-storytelling intervention is superior to an attention control for improving gout outcomes in African-Americans (AAs).
METHODS


In a 1-year, multicenter, randomized controlled trial, AA veterans with gout were randomized to gout-storytelling intervention vs. a stress reduction video (attention control group; 1:1 ratio). The primary outcome was ULT adherence measured with MEMSCap™, an electronic monitoring system that objectively measured ULT medication adherence.
RESULTS


The 306 male AA veterans with gout who met the eligibility criteria were randomized to the gout-storytelling intervention (n = 152) or stress reduction video (n = 154); 261/306 (85%) completed the 1-year study. The mean age was 64 years, body mass index was 33 kg/m 2 , and gout disease duration was 3 years. ULT adherence was similar in the intervention vs. control groups: 3 months, 73% versus 70%; 6 months, 69% versus 69%; 9 months, 66% versus 67%; and 12 months, 61% versus 64% (p > 0.05 each). Secondary outcomes (gout flares, serum urate and gout-specific health-related quality of life [HRQOL]) in the intervention versus control groups were similar at all time points except intervention group outcomes were better for the following: (1) number of gout flares at 9 months were fewer, 0.7 versus 1.3 in the previous month (p = 0.03); (2) lower/better scores on two gout specific HRQOL subscales: gout medication side effects at 3 months, 32.8 vs. 39.6 (p = 0.02); and unmet gout treatment need at 3 months, 30.9 vs. 38.2 (p = 0.003), and 6 months, 29.5 vs. 34.5 (p = 0.03), respectively.
CONCLUSIONS


A culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout.
TRIAL REGISTRATION


Registered at ClinicalTrials.gov NCT02741700.",2021,"A culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout.
","['AA veterans with gout', 'The mean age was 64\u2009years, body mass index was 33\u2009kg/m 2 , and gout disease duration was 3\u2009years', '306 male AA veterans with gout who met the eligibility criteria', 'African American veterans with gout', 'African-Americans (AAs', 'n = 154); 261/306 (85%) completed the 1-year study']","['gout-storytelling intervention vs. a stress reduction video (attention control group;\xa01:1 ratio', 'culturally appropriate gout-storytelling intervention', 'gout-storytelling intervention (n = 152) or stress reduction video', 'Urate-lowering therapy (ULT) adherence']","['ULT adherence', 'number of gout flares', 'ULT adherence measured with MEMSCap™, an electronic monitoring system\xa0that objectively\xa0measured ULT\xa0medication adherence', 'Secondary outcomes (gout flares, serum urate and gout-specific health-related quality of life [HRQOL', 'gout specific HRQOL subscales: gout medication side effects']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149896', 'cui_str': 'Primary gout'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",306.0,0.132363,"A culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout.
","[{'ForeName': 'Jasvinder A', 'Initials': 'JA', 'LastName': 'Singh', 'Affiliation': 'Medicine Service, VA Medical Center, 700 19th St S, Birmingham, AL, 35233, USA. Jasvinder.md@gmail.com.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Richman', 'Affiliation': 'Medicine Service, VA Medical Center, 700 19th St S, Birmingham, AL, 35233, USA.'}, {'ForeName': 'Terrence', 'Initials': 'T', 'LastName': 'Shaneyfelt', 'Affiliation': 'Medicine Service, VA Medical Center, 700 19th St S, Birmingham, AL, 35233, USA.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'Medicine Service, VA Medical Center, 700 19th St S, Birmingham, AL, 35233, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Eisen', 'Affiliation': 'St. Louis Veterans Affairs Medical Center, St. Louis, MO, USA.'}]",BMC medicine,['10.1186/s12916-021-02135-w']
2460,34749710,Work-related factors predict changes in physical activity among nurses participating in a web-based worksite intervention: A randomized controlled trial.,"BACKGROUND


Despite the numerous benefits associated with physical activity (PA), most nurses are not active enough and few interventions have been developed to promote PA among nurses. A secondary analysis of raw data from a single-centre, three-arm parallel-group randomized controlled trial was conducted to assess whether work-related characteristics and general mood states predict changes in total weekly moderate-to-vigorous intensity PA (MVPA) and average daily step-count among nurses participating in a 6-week web-based worksite intervention.
METHODS


Seventy nurses (mean age : 46.1 ± 11.2 years) were randomized to an individual-, friend-, or team-based PA challenge. Participants completed questionnaires pre- and post-intervention assessing work-related characteristics (i.e., shift schedule and length, number of hours worked per week, work role) and general mood states (i.e., tension, depression, anger, confusion, fatigue, vigour). Participants received a PA monitor to wear before and during the 6-week PA challenge, which was used to assess total weekly MVPA minutes and average daily step-count. Data were analyzed descriptively and using multilevel modeling for repeated measures.
RESULTS


Change in total weekly MVPA minutes, but not change in average daily step-count, was predicted by shift schedule (rotating vs. fixed) by time (estimate = - 17.43, SE = 6.18, p = .006), and work role (clinical-only vs. other) by time (estimate = 18.98, SE = 6.51, p = .005). General mood states did not predict change in MVPA or change in average daily step-count.
CONCLUSIONS


Given that nurses who work rotating shifts and perform clinical work showed smaller improvements in MVPA, it may be necessary to consider work-related factors/barriers (e.g., time constraints, fatigue) and collaborate with nurses when designing and implementing MVPA interventions in the workplace.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04524572 . August 24, 2020. This trial was registered retrospectively. This study adheres to the CONSORT 2010 statement guidelines.",2021,"General mood states did not predict change in MVPA or change in average daily step-count.
","['Seventy nurses (mean age : 46.1\u2009±\u200911.2\xa0years', 'nurses participating in a 6-week web-based worksite intervention', 'nurses participating in a web-based worksite intervention']",[],"['physical activity', 'average daily step-count', 'general mood states (i.e., tension, depression, anger, confusion, fatigue, vigour']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.178407,"General mood states did not predict change in MVPA or change in average daily step-count.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Brunet', 'Affiliation': 'School of Human Kinetics, University of Ottawa, 125 University Private, Montpetit Hall, Room 339, Ottawa, ON, K1N 6N5, Canada. jennifer.brunet@uottawa.ca.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Black', 'Affiliation': 'School of Human Kinetics, University of Ottawa, 125 University Private, Montpetit Hall, Room 339, Ottawa, ON, K1N 6N5, Canada.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Tulloch', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, 40 Ruskin Street, Ottawa, Ontario, Canada.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Pipe', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, 40 Ruskin Street, Ottawa, Ontario, Canada.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Reid', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, 40 Ruskin Street, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Reed', 'Affiliation': 'School of Human Kinetics, University of Ottawa, 125 University Private, Montpetit Hall, Room 339, Ottawa, ON, K1N 6N5, Canada.'}]",BMC nursing,['10.1186/s12912-021-00739-4']
2461,34749699,Impact of high-flow oxygen therapy during exercise in idiopathic pulmonary fibrosis: a pilot crossover clinical trial.,"BACKGROUND


Supplemental oxygen delivered with standard oxygen therapy (SOT) improves exercise capacity in patients with idiopathic pulmonary fibrosis (IPF). Although high-flow nasal cannula oxygen therapy (HFNC) improves oxygenation in other respiratory diseases, its impact on exercise performance has never been evaluated in IPF patients. We hypothesized that HFNC may improve exercise capacity in IPF subjects compared to SOT.
METHODS


This was a prospective, crossover, pilot randomized trial that compared both oxygenation methods during a constant submaximal cardiopulmonary exercise test (CPET) in IPF patients with exertional oxygen saturation (SpO 2 ) ≤ 85% in the 6-min walking test. The primary outcome was endurance time (Tlim). Secondary outcomes were muscle oxygen saturation (StO 2 ) and respiratory and leg symptoms.
RESULTS


Ten IPF patients [71.7 (6) years old, 90% males] were included. FVC and DL CO  were 58 ± 11% and 31 ± 13% pred. respectively. Tlim during CPET was significantly greater using HFNC compared to SOT [494 ± 173 vs. 381 ± 137 s, p = 0.01]. HFNC also associated with a higher increase in inspiratory capacity (IC) [19.4 ± 14.2 vs. 7.1 ± 8.9%, respectively; p = 0.04], and a similar trend was observed in StO 2  during exercise. No differences were found in respiratory or leg symptoms between the two oxygen devices.
CONCLUSIONS


This is the first study demonstrating that HFNC oxygen therapy improves exercise tolerance better than SOT in IPF patients with exertional desaturation. This might be explained by changes in ventilatory mechanics and muscle oxygenation. Further and larger studies are needed to confirm the benefits of HFNC in IPF patients and its potential usefulness in rehabilitation programs.",2021,"HFNC also associated with a higher increase in inspiratory capacity (IC) [19.4 ± 14.2 vs. 7.1 ± 8.9%, respectively; p = 0.04], and a similar trend was observed in StO 2  during exercise.","['IPF subjects', 'IPF patients with exertional desaturation', 'Ten IPF patients [71.7 (6) years old, 90% males', 'IPF patients', 'IPF patients with exertional oxygen saturation (SpO 2 )\u2009≤\u200985% in the 6-min walking test', 'patients with idiopathic pulmonary fibrosis (IPF', 'idiopathic pulmonary fibrosis']","['high-flow nasal cannula oxygen therapy (HFNC', 'high-flow oxygen therapy', 'HFNC', 'HFNC oxygen therapy', 'SOT', 'constant submaximal cardiopulmonary exercise test (CPET', 'standard oxygen therapy (SOT']","['exercise capacity', 'endurance time (Tlim', 'inspiratory capacity (IC', 'exercise tolerance', 'muscle oxygen saturation (StO 2 ) and respiratory and leg symptoms', 'respiratory or leg symptoms', 'FVC and DL CO']","[{'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C4761117', 'cui_str': 'High-flow nasal cannula oxygen therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",10.0,0.0652929,"HFNC also associated with a higher increase in inspiratory capacity (IC) [19.4 ± 14.2 vs. 7.1 ± 8.9%, respectively; p = 0.04], and a similar trend was observed in StO 2  during exercise.","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Badenes-Bonet', 'Affiliation': 'Respiratory Department, Servei de Pneumologia, Hospital del Mar, Passeig Marítim 27, 08003, Barcelona, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Cejudo', 'Affiliation': 'Grupo CB17/06/00030, Centro de Investigación en Red de Enfermedades Respiratorias, (CIBERES), Instituto de Salud Carlos III (ISCIII), Sevilla, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rodó-Pin', 'Affiliation': 'Respiratory Department, Servei de Pneumologia, Hospital del Mar, Passeig Marítim 27, 08003, Barcelona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Martín-Ontiyuelo', 'Affiliation': 'Respiratory Department, Servei de Pneumologia, Hospital del Mar, Passeig Marítim 27, 08003, Barcelona, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Chalela', 'Affiliation': 'Respiratory Department, Servei de Pneumologia, Hospital del Mar, Passeig Marítim 27, 08003, Barcelona, Spain.'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Rodríguez-Portal', 'Affiliation': 'Grupo CB17/06/00030, Centro de Investigación en Red de Enfermedades Respiratorias, (CIBERES), Instituto de Salud Carlos III (ISCIII), Sevilla, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Vázquez-Sánchez', 'Affiliation': 'Unidad Médico-Quirúrgica de Enfermedades Respiratorias, University Hospital Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Gea', 'Affiliation': 'Respiratory Department, Servei de Pneumologia, Hospital del Mar, Passeig Marítim 27, 08003, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Duran', 'Affiliation': 'Scientific, Statistics and Technical Department, Hospital del Mar-IMIM, Barcelona, Spain.'}, {'ForeName': 'Oswaldo Antonio', 'Initials': 'OA', 'LastName': 'Caguana', 'Affiliation': 'Respiratory Department, Servei de Pneumologia, Hospital del Mar, Passeig Marítim 27, 08003, Barcelona, Spain.'}, {'ForeName': 'Diego Agustín', 'Initials': 'DA', 'LastName': 'Rodriguez-Chiaradia', 'Affiliation': 'Respiratory Department, Servei de Pneumologia, Hospital del Mar, Passeig Marítim 27, 08003, Barcelona, Spain. DARodriguez@parcdesalutmar.cat.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Balcells', 'Affiliation': 'Respiratory Department, Servei de Pneumologia, Hospital del Mar, Passeig Marítim 27, 08003, Barcelona, Spain.'}]",BMC pulmonary medicine,['10.1186/s12890-021-01727-9']
2462,34749675,Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study.,"BACKGROUND


Low adherence to investigational products can negatively impact study outcomes, limiting the ability to demonstrate efficacy. To continue advancing potential new HIV prevention technologies, efforts are needed to improve adherence among study participants. In MTN-020/ASPIRE, a phase III randomized, double-blind, placebo-controlled study of the dapivirine vaginal ring carried out across 15 sites in sub-Saharan Africa, a multifaceted approach to adherence support was implemented, including a strong focus on participant engagement activities (PEAs). In this manuscript, we describe PEAs and participant attendance, and analyze the potential impact of PEAs on ring use.
METHODS


All sites implemented PEAs and submitted activity and attendance reports to the study management team throughout the study. Participant demographics were collected via case report forms. Residual dapivirine remaining in the last ring returned by each participant was used to estimate drug released from the ring, which was then adjusted for time participants had the ring to calculate probable use categorized into three levels (low/intermittent/high). Product use was connected to PEA attendance using participant identification numbers. We used multivariate Poisson regression with robust standard errors to explore differences in ring use between PEA attendance groups and reviewed qualitative reports for illustrative quotes highlighting participant experiences with PEAs.
RESULTS


2312 of 2629 study participants attended at least one of 389 PEAs conducted across sites. Participant country and partner knowledge of study participation were most strongly associated with PEA attendance (p < 0.005) with age, education, and income status also associated with event attendance (p < 0.05). When controlling for these variables, participants who attended at least one event were more likely to return a last ring showing at least some use (RR = 1.40) than those who never attended an event. There was a stronger correlation between a last returned ring showing use and participant attendance at multiple events (RR = 1.52).
CONCLUSIONS


Our analysis supports the growing body of work illustrating the importance of meaningfully engaging research participants to achieve study success and aligns with other analyses of adherence support efforts during ASPIRE. While causation between PEA attendance and product use cannot be established, residual drug levels in returned rings strongly correlated with participant attendance at PEAs, and the benefits of incorporating PEAs should be considered when designing future studies of investigational products.",2021,"Participant country and partner knowledge of study participation were most strongly associated with PEA attendance (p < 0.005) with age, education, and income status also associated with event attendance (p < 0.05).","['participants enrolled in the phase III MTN-020/ASPIRE study', '2312 of 2629 study participants']",['placebo'],['PEA attendance'],"[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",2629.0,0.0727865,"Participant country and partner knowledge of study participation were most strongly associated with PEA attendance (p < 0.005) with age, education, and income status also associated with event attendance (p < 0.05).","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': 'Global Health Population and Nutrition, FHI, Durham, NC, 360, USA. mgarcia@fhi360.org.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Luecke', 'Affiliation': ""Women's Global Health Imperative (WGHI) RTI International, Berkeley, CA, USA; ASTRA Consulting, Kensington, CA, USA.""}, {'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Mayo', 'Affiliation': 'Global Health Population and Nutrition, FHI, Durham, NC, 360, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Scheckter', 'Affiliation': 'Global Health Population and Nutrition, FHI, Durham, NC, 360, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ndase', 'Affiliation': 'Population Services International (PSI), 1120 19th St. NW, Washington, DC, USA.'}, {'ForeName': 'Flavia Matovu', 'Initials': 'FM', 'LastName': 'Kiweewa', 'Affiliation': 'Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Kemigisha', 'Affiliation': 'Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Petina', 'Initials': 'P', 'LastName': 'Musara', 'Affiliation': 'University of Zimbabwe College of Health Sciences-Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Leila E', 'Initials': 'LE', 'LastName': 'Mansoor', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Nishanta', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'HIV Prevention Research Unit (HPRU), South African Medical Research Council (SAMRC), Durban, South Africa.'}, {'ForeName': 'Kubashni', 'Initials': 'K', 'LastName': 'Woeber', 'Affiliation': 'HIV Prevention Research Unit (HPRU), South African Medical Research Council (SAMRC), Durban, South Africa.'}, {'ForeName': 'Neetha S', 'Initials': 'NS', 'LastName': 'Morar', 'Affiliation': 'HIV Prevention Research Unit (HPRU), South African Medical Research Council (SAMRC), Durban, South Africa.'}, {'ForeName': 'Nitesha', 'Initials': 'N', 'LastName': 'Jeenarain', 'Affiliation': 'HIV Prevention Research Unit (HPRU), South African Medical Research Council (SAMRC), Durban, South Africa.'}, {'ForeName': 'Zakir', 'Initials': 'Z', 'LastName': 'Gaffoor', 'Affiliation': 'HIV Prevention Research Unit (HPRU), South African Medical Research Council (SAMRC), Durban, South Africa.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Gondwe', 'Affiliation': 'College of Medicine - Johns Hopkins Bloomberg School of Public Health, Blantyre, Malawi.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Makala', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Llewellyn', 'Initials': 'L', 'LastName': 'Fleurs', 'Affiliation': 'Desmond Tutu HIV Foundation, Emavundleni Clinical Research Site, Cape Town, South Africa.'}, {'ForeName': 'Krishnaveni', 'Initials': 'K', 'LastName': 'Reddy', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""Women's Global Health Imperative (WGHI) RTI International, Berkeley, CA, USA; ASTRA Consulting, Kensington, CA, USA.""}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Torjesen', 'Affiliation': 'Global Health Population and Nutrition, FHI, Durham, NC, 360, USA.'}]",BMC public health,['10.1186/s12889-021-11919-x']
2463,34750149,"Study protocol: a multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous macrophage therapy for liver cirrhosis (MATCH).","INTRODUCTION


Liver cirrhosis is a growing global healthcare challenge. Cirrhosis is characterised by severe liver fibrosis, organ dysfunction and complications related to portal hypertension. There are no licensed antifibrotic or proregenerative medicines and liver transplantation is a scarce resource. Hepatic macrophages can promote both liver fibrogenesis and fibrosis regression. The safety and feasibility of peripheral infusion of ex vivo matured autologous monocyte-derived macrophages in patients with compensated cirrhosis has been demonstrated.
METHODS AND ANALYSIS


The efficacy of autologous macrophage therapy, compared with standard medical care, will be investigated in a cohort of adult patients with compensated cirrhosis in a multicentre, open-label, parallel-group, phase 2, randomised controlled trial. The primary outcome is the change in Model for End-Stage Liver Disease score at 90 days. The trial will provide the first high-quality examination of the efficacy of autologous macrophage therapy in improving liver function, non-invasive fibrosis markers and other clinical outcomes in patients with compensated cirrhosis.
ETHICS AND DISSEMINATION


The trial will be conducted according to the ethical principles of the Declaration of Helsinki 2013 and has been approved by Scotland A Research Ethics Committee (reference 15/SS/0121), National Health Service Lothian Research and Development department and the Medicine and Health Care Regulatory Agency-UK. Final results will be presented in peer-reviewed journals and at relevant conferences.
TRIAL REGISTRATION NUMBERS


ISRCTN10368050 and EudraCT; reference 2015-000963-15.",2021,"The safety and feasibility of peripheral infusion of ex vivo matured autologous monocyte-derived macrophages in patients with compensated cirrhosis has been demonstrated.
","['adult patients with compensated cirrhosis', 'patients with compensated cirrhosis', 'liver cirrhosis (MATCH']","['autologous macrophage therapy', 'peripheral infusion of ex vivo matured autologous monocyte-derived macrophages']",['change in Model for End-Stage Liver Disease score'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205286', 'cui_str': 'Mature'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4048785', 'cui_str': 'Model for end stage liver disease score'}]",,0.180599,"The safety and feasibility of peripheral infusion of ex vivo matured autologous monocyte-derived macrophages in patients with compensated cirrhosis has been demonstrated.
","[{'ForeName': 'Paul Noel', 'Initials': 'PN', 'LastName': 'Brennan', 'Affiliation': 'Centre for Regenerative Medicine, The University of Edinburgh Medical School, Edinburgh, UK pbrenna2@ed.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'MacMillan', 'Affiliation': 'Centre for Regenerative Medicine, The University of Edinburgh Medical School, Edinburgh, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Manship', 'Affiliation': 'CLDD, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Moroni', 'Affiliation': 'Department of Gastroenterology, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Glover', 'Affiliation': 'Scottish National Blood Transfusion Service, Edinburgh, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': 'Deanery of Clinical Sciences, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh Deanery of Clinical Sciences, Edinburgh, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Morris', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh Deanery of Clinical Sciences, Edinburgh, UK.'}, {'ForeName': 'Alasdair R', 'Initials': 'AR', 'LastName': 'Fraser', 'Affiliation': 'Tissues, Cells and Advanced Therapeutics, SNBTS, Edinburgh, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Pass', 'Affiliation': 'Tissues, Cells and Advanced Therapeutics, SNBTS, Edinburgh, UK.'}, {'ForeName': 'Neil W A', 'Initials': 'NWA', 'LastName': 'McGowan', 'Affiliation': 'Tissues, Cells and Advanced Therapeutics, SNBTS, Edinburgh, UK.'}, {'ForeName': 'Marc L', 'Initials': 'ML', 'LastName': 'Turner', 'Affiliation': 'Tissues, Cells and Advanced Therapeutics, SNBTS, Edinburgh, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Lachlan', 'Affiliation': 'Department of Gastroenterology, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dillon', 'Affiliation': 'Liver Group, University of Dundee Division of Cardiovascular and Diabetes Medicine, Dundee, UK.'}, {'ForeName': 'John D M', 'Initials': 'JDM', 'LastName': 'Campbell', 'Affiliation': 'Tissues, Cells and Advanced Therapeutics, SNBTS, Edinburgh, UK.'}, {'ForeName': 'Jonathan Andrew', 'Initials': 'JA', 'LastName': 'Fallowfield', 'Affiliation': ""Queen's Medical Research Institute, University of Edinburgh MRC Centre for Inflammation Research, Edinburgh, UK.""}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Forbes', 'Affiliation': 'Centre for Regenerative Medicine, The University of Edinburgh Deanery of Clinical Sciences, Edinburgh, UK.'}]",BMJ open,['10.1136/bmjopen-2021-053190']
2464,34750146,A randomized double-blind placebo-controlled trial of oral aspirin for protection of melanocytic nevi against UV-induced DNA damage.,"DNA damage plays a role in ultraviolet (UV)-induced melanoma. We previously showed that aspirin (ASA) can suppress prostaglandin-E2 (PGE2) and protect melanocytes from UV-induced DNA damage in mice, and suggested that taking ASA before acute sun exposure may reduce melanoma risk. We conducted a prospective randomized placebo-controlled trial to determine if orally administered ASA could suppress PGE2 in plasma and nevi and protect nevi from UV-induced DNA damage. After obtaining plasma and determining the minimal erythemal dose (MED) in 95 subjects at increased risk for melanoma, they were randomized to receive a daily dose of placebo, 81 mg ASA, or 325 mg ASA, in double-blind fashion for one month. After this intervention, one nevus was irradiated (dose = 1 or 2 MED) using a solar simulator. One day later, MED was re-determined, a second plasma sample was obtained, and the UV-irradiated nevus and an unirradiated nevus were removed. ASA metabolites were detected in the second plasma sample in subjects in the ASA arms. There were no significant differences in the pre- and post-intervention MED between those patients receiving ASA and placebo. Significantly reduced PGE2 levels were detected in plasma (second vs. first samples) and in nevi (both unirradiated and UV-treated) in subjects receiving ASA compared to placebo. Comparing UV-treated nevi from the ASA and placebo cohorts, however, did not reveal significant reductions in CD3-cell infiltration or 8-oxoguanine and cyclobutane pyrimidine dimers. Thus ASA did not effectively protect nevi from solar-simulated UV -induced inflammation and DNA damage under the conditions examined.",2021,Significantly reduced PGE2 levels were detected in plasma (second vs. first samples) and in nevi (both unirradiated and UV-treated) in subjects receiving ASA compared to placebo.,['95 subjects at increased risk for melanoma'],"['ASA', 'placebo', 'oral aspirin', 'aspirin (ASA']","['ASA metabolites', 'PGE2 levels']","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.251396,Significantly reduced PGE2 levels were detected in plasma (second vs. first samples) and in nevi (both unirradiated and UV-treated) in subjects receiving ASA compared to placebo.,"[{'ForeName': 'Nwanneka', 'Initials': 'N', 'LastName': 'Okwundu', 'Affiliation': 'Huntsman Cancer Institute, University of Utah.'}, {'ForeName': 'Hafeez', 'Initials': 'H', 'LastName': 'Rahman', 'Affiliation': 'Huntsman Cancer Institute, University of Utah.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Oncological Sciences, University of Utah.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Florell', 'Affiliation': 'Dermatology, University of Utah.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Boucher', 'Affiliation': 'Internal Medicine, University of Utah.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Grossman', 'Affiliation': 'Huntsman Cancer Institute, University of Utah doug.grossman@hci.utah.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-21-0399']
2465,34750128,Peer Coaching to Improve Diabetes Self-Management Among Low-Income Black Veteran Men: A Mixed Methods Assessment of Enrollment and Engagement.,"PURPOSE


We undertook a study to ascertain patient characteristics associated with enrollment and engagement in a type 2 diabetes peer health coaching program at an urban health care facility serving predominantly Black veteran men, to improve the targeting of such programs.
METHODS


A total of 149 patients declined enrollment in a randomized controlled trial but provided sociodemographic, clinical, and psychosocial information. A total of 290 patients enrolled and were randomized to 2 peer coaching programs; they provided sociodemographic, clinical, and survey data, and were analyzed according to their level of program engagement (167 engaged, 123 did not engage) irrespective of randomization group. Qualitative interviews were conducted with 14 engaged participants.
RESULTS


Patients who enrolled were more likely to be Black men, have higher levels of education, have higher baseline hemoglobin A 1c  levels, describe their diabetes self-management as ""fair"" or ""poor,"" and agree they ""find it easy to get close to others"" ( P  <.05 for each). At the program's end, patients who had engaged were more likely than those who had not to describe their peer coaches as being supportive of their autonomy (mean score, 85.4 vs 70.7;  P  <.001). The importance of coaches being encouraging, supportive, and having common ground/shared experiences with participants also emerged as key themes in interviews with engaged participants.
CONCLUSION


Individuals with greatest perceived need were more likely to enroll in our trial of peer coaching, but the only factor associated with engagement was finding one's coach to support autonomy. Our findings reinforce the importance of training and ensuring fidelity of peer coaches to autonomy-supportive communication styles for participant engagement. In tailoring peer support programs for Black men, future research should elucidate which shared characteristics between participant and peer coach are most important for engagement and improved outcomes. Visual abstract .",2021,"Individuals with greatest perceived need were more likely to enroll in our trial of peer coaching, but the only factor associated with engagement was finding one's coach to support autonomy.","['type 2 diabetes peer health coaching program at an urban health care facility serving predominantly Black veteran men', 'Patients who enrolled were more likely to be Black men', '149 patients', 'Black men', '14 engaged participants', '290 patients enrolled', 'Low-Income Black Veteran Men']",['Peer Coaching'],['Visual abstract '],"[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0041933', 'cui_str': 'Urban Health'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",[],"[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]",290.0,0.129224,"Individuals with greatest perceived need were more likely to enroll in our trial of peer coaching, but the only factor associated with engagement was finding one's coach to support autonomy.","[{'ForeName': 'Cassie D', 'Initials': 'CD', 'LastName': 'Turner', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan cpringle@med.umich.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lindsay', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}]",Annals of family medicine,['10.1370/afm.2742']
2466,34750127,Where Trust Flourishes: Perceptions of Clinicians Who Trust Their Organizations and Are Trusted by Their Patients.,"PURPOSE


Trust is an essential component of health care. Clinicians need to trust organizational leaders to provide a safe and effective work environment, and patients need to trust their clinicians to deliver high-quality care while addressing their health care needs. We sought to determine perceived characteristics of clinics by clinicians who trust their organizations and whose patients have trust in them.
METHODS


We used baseline data from the Healthy Work Place trial, a randomized trial of interventions to improve work life in 34 Midwest and East Coast primary care clinics, to identify clinic characteristics associated with high clinician and patient trust.
RESULTS


The study included 165 clinicians with 1,132 patients. High trust by clinicians with patients who trusted them was found for 34% of 162 clinicians with sufficient data for modeling. High clinician-high patient trust occurred when clinicians perceived their organizational cultures to have (1) an emphasis on quality (odds ratio [OR] 4.95; 95% CI, 2.02-12.15;  P  <.001), (2) an emphasis on communication and information (OR 3.21; 95% CI, 1.33-7.78;  P  = .01), (3) cohesiveness among clinicians (OR 2.29; 95% CI, 1.25-4.20;  P  = .008), and (4) values alignment between clinicians and leaders (OR 1.86; 95% CI, 1.23-2.81;  P  = .003).
CONCLUSION


Addressing organizational culture might improve the trust of clinicians whose patients have high trust in them.",2021,High trust by clinicians with patients who trusted them was found for 34% of 162 clinicians with sufficient data for modeling.,"['165 clinicians with 1,132 patients', '34 Midwest and East Coast primary care clinics, to identify clinic characteristics associated with high clinician and patient trust']",[],[],"[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]",[],[],165.0,0.116121,High trust by clinicians with patients who trusted them was found for 34% of 162 clinicians with sufficient data for modeling.,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Linzer', 'Affiliation': 'Hennepin Healthcare Research Institute, Hennepin Healthcare, Minneapolis, MN mark.linzer@hcmed.org.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Neprash', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'University of Wisconsin School of Nursing, Madison, WI.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': 'University of Alabama, Tuscaloosa, AL.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Audi', 'Affiliation': 'Hennepin Healthcare Research Institute, Hennepin Healthcare, Minneapolis, MN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Poplau', 'Affiliation': 'Hennepin Healthcare Research Institute, Hennepin Healthcare, Minneapolis, MN.'}, {'ForeName': 'Kriti', 'Initials': 'K', 'LastName': 'Prasad', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Dhruv', 'Initials': 'D', 'LastName': 'Khullar', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of family medicine,['10.1370/afm.2732']
2467,34750077,The EFFect of dietary fat content on the recurrence of pancreaTitis (EFFORT): Protocol of a multicenter randomized controlled trial.,"BACKGROUND


Around 20% of patients with acute pancreatitis (AP) will develop acute recurrent pancreatitis (ARP) and 10% will progress to chronic pancreatitis. While interventions to avoid recurrences exist for the two most common causes - abstinence for alcoholic and cholecystectomy for biliary pancreatitis - the are no known preventive measures in idiopathic ARP. Though it is not included in any of the guidelines, a low-fat diet is often recommended. Our aim is to test dietary fat reduction's effect on AP recurrence in a randomized controlled setting, in order to provide high-quality evidence for the validity of such an intervention.
METHODS, DESIGN


Participants with at least 2 episodes of AP in the preceding 2 years of which the last episode was idiopathic will be randomized to one of two diets with different fat contents: a 'reduced fat diet' (15% fat, 65% carbohydrate, 20% protein) and a 'standard healthy diet' (30% fat, 50% carbohydrate, 20% protein; based on WHO recommendations). Participants will be followed-up for 2 years (visits will be scheduled for months 3, 6, 12, 18 and 24) during which they will receive a repeated session of nutritional guidance, complete food frequency questionnaires and data on relapse, mortality, BMI, cardiovascular parameters and serum lipid values will be collected.
DISCUSSION


This study will determine the effect of modifying the dietary fat content on AP recurrence, mortality, serum lipids and weight loss in idiopathic cases.",2021,"This study will determine the effect of modifying the dietary fat content on AP recurrence, mortality, serum lipids and weight loss in idiopathic cases.","['Participants with at least 2 episodes of AP in the preceding 2 years of which the last episode was idiopathic', 'idiopathic cases', 'patients with acute pancreatitis (AP']","[""diets with different fat contents: a 'reduced fat diet' (15% fat, 65% carbohydrate, 20% protein) and a 'standard healthy diet' (30% fat, 50% carbohydrate, 20% protein; based on WHO recommendations""]","['relapse, mortality, BMI, cardiovascular parameters and serum lipid values', 'AP recurrence, mortality, serum lipids and weight loss']","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0301585', 'cui_str': 'Fat diet'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0219642,"This study will determine the effect of modifying the dietary fat content on AP recurrence, mortality, serum lipids and weight loss in idiopathic cases.","[{'ForeName': 'Márk Félix', 'Initials': 'MF', 'LastName': 'Juhász', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary; Centre for Translational Medicine, Semmelweis University, Budapest, Hungary. Electronic address: flixjuhsz@gmail.com.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Vereczkei', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary. Electronic address: vereczkei47@gmail.com.'}, {'ForeName': 'Klementina', 'Initials': 'K', 'LastName': 'Ocskay', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary. Electronic address: ocskay.klementina@gmail.com.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Szakó', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary. Electronic address: szaklaj@gmail.com.'}, {'ForeName': 'Nelli', 'Initials': 'N', 'LastName': 'Farkas', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary. Electronic address: farkas.nelli@gmail.com.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Szakács', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary. Electronic address: szaki92@gmail.com.'}, {'ForeName': 'Noémi', 'Initials': 'N', 'LastName': 'Zádori', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary. Electronic address: znoeemi@gmail.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wilschanski', 'Affiliation': 'Hadassah Hebrew University Medical Center, Jerusalem, Israel. Electronic address: michaelwil@hadassah.org.il.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Pandol', 'Affiliation': 'Cedars-Sinai Medical Center and University of California, Los Angeles, USA. Electronic address: pandol.stephen@gmail.com.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Centre for Intestinal Failure, Department of Gastroenterology and Nutritional Support, Hôpital Beaujon, Clichy, France. Electronic address: francisca.joly@gmail.com.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Capurso', 'Affiliation': 'Pancreato-Biliary Endoscopy and Endosonography Division, Pancreas Translational and Clinical Research Centre, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: gabriele.capurso@gmail.com.'}, {'ForeName': 'Paolo Giorgio', 'Initials': 'PG', 'LastName': 'Arcidiacono', 'Affiliation': 'Pancreato-Biliary Endoscopy and Endosonography Division, Pancreas Translational and Clinical Research Centre, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Ferenc', 'Initials': 'F', 'LastName': 'Izbéki', 'Affiliation': 'Szent György Teaching Hospital of County Fejér, Székesfehérvár, Hungary. Electronic address: izbeki@mail.fmkorhaz.hu.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Czakó', 'Affiliation': 'First Department of Medicine, University of Szeged, Szeged, Hungary. Electronic address: czako.laszlo@med.u-szeged.hu.'}, {'ForeName': 'Mária', 'Initials': 'M', 'LastName': 'Papp', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Hungary. Electronic address: papp.maria@med.unideb.hu.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Czopf', 'Affiliation': 'First Department of Internal Medicine, Medical School, University of Pécs, Pécs, Hungary. Electronic address: laszlo.czopf@aok.pte.hu.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Hegyi', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary; Centre for Translational Medicine, Semmelweis University, Budapest, Hungary; Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary. Electronic address: hegyi2009@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Párniczky', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary; Centre for Translational Medicine, Semmelweis University, Budapest, Hungary; Heim Pál National Pediatric Institute, Budapest, Hungary. Electronic address: andrea.parniczky@gmail.com.'}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2021.10.002']
2468,34750069,The efficacy of weekly and bi-weekly heat training to maintain the physiological benefits of heat acclimation.,"OBJECTIVES


To examine the efficacy of weekly and bi-weekly heat training to maintain heat acclimatization (HAz) and heat acclimation (HA) for 8 weeks in aerobically trained athletes.
DESIGN


Randomized, between-group.
METHODS


Twenty-four males (mean [m ± standard deviation [sd]; (age, 34 ± 12 y; body mass, 72.6 ± 8.8 kg, VO 2peak , 57.7 ± 6.8 mL·kg -1 ·min -1 ) completed five trials (baseline, following HAz, following HA (HAz + HA), four weeks into heat training [HT WK4 ], and eight weeks into HT [HT WK8 ] that involved 60 min of steady-state exercise (59.1 ± 1.8% vVO 2peak ) in an environmental laboratory (wet bulb globe temperature [WBGT], 29.6 ± 1.4 °C) on a motorized treadmill. Throughout exercise, heart rate (HR) and rectal temperature (T rec ) were recorded. Following HAz + HA, participants were assigned to three groups: control group (HT 0 ), once per week heat training (HT 1 ), and twice per week heat training (HT 2 ). HT involved heated exercise (WBGT, 33.3 ± 1.3 °C) to achieve hyperthermia (38.5-39.75 °C) for 60 min. Repeated measures ANOVAs were used to determine differences.
RESULTS


HAz + HA resulted in significant improvements in HR (p < 0.001) and T rec  (p < 0.001). At HT WK8 , HR was significantly higher in HT 0  (174 ± 22 beats⋅min -1 ) compared to HT 2  (151 ± 17 beats⋅min -1 , p < 0.023), but was not different than HT 1  (159 ± 17 beats⋅min -1 , p = 0.112). There was no difference in % change of T rec  from post-HAz + HA to HT WK4  (0.6 ± 1.3%; p = 0.218), however, HT WK8  (1.8 ± 1.4%) was significantly greater than post-HAz + HA in HT 0  (p = 0.009).
CONCLUSIONS


Bi-weekly HT provided clear evidence for the ability to maintain physiological adaptions for 8 weeks following HA.",2021,"RESULTS


HAz + HA resulted in significant improvements in HR (p < 0.001) and T rec  (p < 0.001).","['aerobically trained athletes', 'Twenty-four males (mean [m\u202f±\u202fstandard deviation [sd]; (age, 34\u202f±\u202f12 y; body mass, 72.6\u202f±\u202f8.8\u202fkg, VO 2peak , 57.7\u202f±\u202f6.8\u202fmL·kg -1 ·min -1 ) completed five trials (baseline, following']","['control group (HT 0 ), once per week heat training (HT 1 ), and twice per week heat training (HT 2 ', 'HAz, following HA (HAz\u202f+\u202fHA), four weeks into heat training [HT WK4 ], and eight weeks into HT [HT WK8 ] that involved 60\u202fmin of steady-state exercise (59.1\u202f±\u202f1.8% vVO 2peak ) in an environmental laboratory (wet bulb globe temperature [WBGT], 29.6\u202f±\u202f1.4\u202f°C) on a motorized treadmill', 'bi-weekly heat training to maintain heat acclimatization (HAz) and heat acclimation (HA', 'HAz\u202f+\u202fHA']","['heart rate (HR) and rectal temperature (T rec ', 'HR']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0025148', 'cui_str': 'Medulla oblongata structure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C2606415', 'cui_str': 'ZDHHC2 protein, human'}]",,0.040219,"RESULTS


HAz + HA resulted in significant improvements in HR (p < 0.001) and T rec  (p < 0.001).","[{'ForeName': 'Courteney L', 'Initials': 'CL', 'LastName': 'Benjamin', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, USA; Department of Kinesiology, Samford University, USA. Electronic address: cbenjami@samford.edu.'}, {'ForeName': 'Yasuki', 'Initials': 'Y', 'LastName': 'Sekiguchi', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, USA; Sports Performance Lab, Department of Kinesiology and Sport Management, Texas Tech University, USA.'}, {'ForeName': 'Lawrence E', 'Initials': 'LE', 'LastName': 'Armstrong', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, USA.'}, {'ForeName': 'Ciara N', 'Initials': 'CN', 'LastName': 'Manning', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, USA.'}, {'ForeName': 'Jeb F', 'Initials': 'JF', 'LastName': 'Struder', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, USA.'}, {'ForeName': 'Cody R', 'Initials': 'CR', 'LastName': 'Butler', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Huggins', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Stearns', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, USA.'}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Lee', 'Affiliation': 'Human Performance Laboratory, Department of Kinesiology, University of Connecticut, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Casa', 'Affiliation': 'Korey Stringer Institute, University of Connecticut, USA.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2021.10.006']
2469,34750057,"Comparison of Long-Term Efficacy and Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Younger Versus Older Patients With Treatment-Resistant Depression: Post-Hoc Analysis of SUSTAIN-2, a Long-Term Open-Label Phase 3 Safety and Efficacy Study.","BACKGROUND


Older, compared with younger, patients with treatment-resistant depression (TRD) typically have lower response and remission rates with poorer tolerability to antidepressant treatment. This post-hoc analysis compared outcomes following treatment with esketamine nasal spray (ESK) between younger (18-64 years) and older (≥65 years) patients with TRD.
METHODS


SUSTAIN-2, an up to 1-year open-label safety and efficacy study of ESK plus an oral antidepressant, included patients with TRD either directly enrolled (≥18-year) or transferred from a phase 3 double-blind study, TRANSFORM-3 (≥65-year). Patients were treated in two phases: 4-week induction and 48-week optimization/maintenance.
RESULTS


Younger (n = 624) and older (n = 178) patients had similar baseline characteristics except for hypertension history (21.5% versus 48.3%, respectively). Patients (younger versus older) had similar mean baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total scores and mean (SD) reductions in MADRS total scores for induction (-18.0 [7.19] versus -18.1 [9.37]; p = 0.492 [t = 0.69, df = 701]) and optimization/maintenance (week 12) (-19.9 [7.03] versus -22.2 [9.50]; p = 0.265 [t = -1.12, df = 3470]) phases. Treatment-emergent adverse events (TEAEs) reported in younger versus older patients, respectively, were: induction, 86.1% versus 74.8%; optimization/maintenance, 86.8% versus 81.0%; serious TEAEs: induction, 2.2% versus 1.9%; optimization/maintenance, 6.7% versus 4.8%; TEAEs of increased blood pressure: induction, 6.9% versus 6.5%; optimization/maintenance, 7.1% versus 9.5%; and falls: induction, 0.3% versus 0.6%; optimization/maintenance, 0.2% versus 0.8%. Cognitive tests did not show clinically meaningful differences between the age groups.
CONCLUSIONS


Although limited by the open-label design of SUSTAIN-2, this post-hoc analysis showed generally comparable improvement in depression between ESK-treated younger and older adult patients with TRD, with consistent safety outcomes.",2021,"Cognitive tests did not show clinically meaningful differences between the age groups.
","['younger (18-64 years) and older (≥65 years) patients with TRD', 'patients with TRD either directly enrolled (≥18-year) or transferred from a phase 3 double-blind study, TRANSFORM-3 (≥65-year', 'Younger Versus Older Patients', 'Younger (n\xa0=\xa0624) and older (n\xa0=\xa0178) patients had similar baseline characteristics except for hypertension history (21.5% versus 48.3%, respectively']","['Esketamine Nasal Spray Plus Oral Antidepressant', 'esketamine nasal spray (ESK', 'ESK']","['Cognitive tests', 'depression', 'mean baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total scores and mean (SD) reductions in MADRS total scores for induction ', 'blood pressure: induction']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0019664', 'cui_str': 'History'}]","[{'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",178.0,0.0973919,"Cognitive tests did not show clinically meaningful differences between the age groups.
","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ochs-Ross', 'Affiliation': 'Janssen Research and Development (RO-R, RL, PL, DH, HM), Titusville, NJ. Electronic address: rfochs21@gmail.com.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wajs', 'Affiliation': 'Janssen Research and Development (EW), Beerse, Belgium.'}, {'ForeName': 'Ella J', 'Initials': 'EJ', 'LastName': 'Daly', 'Affiliation': 'Janssen Neuroscience Medical Affairs (EJD), Titusville, NJ.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research and Development (YZ, CJ), Fermont, CA.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'Janssen Research and Development (RO-R, RL, PL, DH, HM), Titusville, NJ.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Janssen Research and Development (RO-R, RL, PL, DH, HM), Titusville, NJ.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Janssen Research and Development (WCD, JBS), San Diego, CA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Steffens', 'Affiliation': 'University of Connecticut School of Medicine (DCS), Farmington, CT.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'The Yale Depression Research Program, Yale University (GS), New Haven, CT.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Jamieson', 'Affiliation': 'Janssen Research and Development (YZ, CJ), Fermont, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hough', 'Affiliation': 'Janssen Research and Development (RO-R, RL, PL, DH, HM), Titusville, NJ.'}, {'ForeName': 'Husseini', 'Initials': 'H', 'LastName': 'Manji', 'Affiliation': 'Janssen Research and Development (RO-R, RL, PL, DH, HM), Titusville, NJ.'}, {'ForeName': 'Jaskaran B', 'Initials': 'JB', 'LastName': 'Singh', 'Affiliation': 'Janssen Research and Development (WCD, JBS), San Diego, CA.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2021.09.014']
2470,34750035,First-line Nivolumab plus Ipilimumab Versus Sunitinib in Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial.,"We present an exploratory post hoc analysis from the phase 3 CheckMate 214 trial of first-line nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib in a subgroup of 108 patients with advanced renal cell carcinoma (aRCC) without prior nephrectomy and with an evaluable primary tumor, a population under-represented in clinical trials. Patients with clear cell aRCC were randomized to NIVO+IPI every 3 wk for four doses followed by NIVO monotherapy, or sunitinib every day for 4 wk (6-wk cycle). Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and primary tumor shrinkage were assessed. PFS and ORR were assessed per independent radiology review committee using RECIST version 1.1. With minimum study follow-up of 4 yr for intent-to-treat patients, OS favored NIVO+IPI (n = 53) over sunitinib (n = 55; hazard ratio 0.63, 95% confidence interval 0.40-1.0) among patients without prior nephrectomy. ORR was higher (34% vs 15%; p = 0.0041) and median duration of response was longer with NIVO+IPI versus sunitinib (20.5 vs 14.1 mo); the best overall response was partial response in either arm. A ≥30% reduction in the diameter of intact target renal tumors was achieved in 35% of patients with NIVO+IPI versus 20% with sunitinib. Safety was consistent with the global study population. In conclusion, in patients with aRCC without prior nephrectomy and with an evaluable primary tumor, NIVO+IPI showed survival benefits and renal tumor reduction versus sunitinib. This trial is registered at ClinicalTrials.gov as NCT02231749. PATIENT SUMMARY: In an exploratory analysis of a large global trial (CheckMate 214), we observed positive outcomes (both survival and tumor response to treatment) with nivolumab plus ipilimumab over sunitinib in a subgroup of patients with advanced kidney cancer who did not undergo removal of their primary kidney tumor. This subset of patients represents a population that has not been studied in clinical trials and for whom outcomes with new immunotherapy combination regimens are not yet known. We conclude that treatment with nivolumab plus ipilimumab offers these patients a survival benefit versus sunitinib, consistent with that observed in the overall study, as well as a notable kidney tumor reduction.",2021,ORR was higher (34% vs 15%; p = 0.0041) and median duration of response was longer with NIVO+IPI versus sunitinib (20.5 vs 14.1 mo); the best overall response was partial response in either arm.,"['patients with advanced kidney cancer who did not undergo removal of their primary kidney tumor', 'Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial', '108 patients with advanced renal cell carcinoma (aRCC) without prior nephrectomy and with an evaluable primary tumor, a population under-represented in clinical trials', 'Patients with clear cell aRCC']","['nivolumab plus ipilimumab', 'nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib', 'First-line Nivolumab plus Ipilimumab Versus Sunitinib', 'NIVO monotherapy, or sunitinib']","['survival benefit', 'survival benefits and renal tumor reduction', 'ORR', 'Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and primary tumor shrinkage', 'diameter of intact target renal tumors', 'median duration of response', 'PFS and ORR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0022665', 'cui_str': 'Neoplasm of kidney'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022665', 'cui_str': 'Neoplasm of kidney'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",108.0,0.200007,ORR was higher (34% vs 15%; p = 0.0041) and median duration of response was longer with NIVO+IPI versus sunitinib (20.5 vs 14.1 mo); the best overall response was partial response in either arm.,"[{'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Department of Cancer Medicine, Gustave Roussy, Villejuif, France. Electronic address: laurence.albiges@gustaveroussy.fr.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Burotto', 'Affiliation': 'Bradford Hill Clinical Research Center, Santiago, Chile.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDermott', 'Affiliation': 'Division of Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthélémy', 'Affiliation': 'Medical Oncology, Institut de Cancérologie Strasbourg Europe, Strasbourg, France.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'University of Pavia, Pavia, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Urology, Barts Cancer Institute, Queen Mary University of London, Royal Free NHS Trust, London, UK.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Department of Medicine, British Columbia Cancer Agency, Vancouver, Canada.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, Australia.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Medical Oncology Service, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Division of Hematology Oncology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Department of Medical Oncology, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leung', 'Affiliation': 'Department of Imaging, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Shruti Shally', 'Initials': 'SS', 'LastName': 'Saggi', 'Affiliation': 'Department of Clinical Trials, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Chung-Wei', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Trials, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Department of Biostatistics, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",European urology,['10.1016/j.eururo.2021.10.001']
2471,34749997,Child internalizing symptoms during the COVID-19 pandemic among maltreating and non-maltreating families: Examining the effects of family resources and the Reminiscing and Emotion Training intervention.,"BACKGROUND


The effects of the COVID-19 pandemic on child functioning have been especially pronounced among low-income families. Protective factors, including sensitive reminiscing and sufficient family resources, may reduce the negative effects of the pandemic on child adjustment.
OBJECTIVE


The current study investigated how family resources during the pandemic, race, maltreatment, and pre-pandemic involvement in an emotion socialization intervention (M years ago  = 4.37, SD = 1.36) were associated with child internalizing symptoms during the pandemic.
PARTICIPANTS AND SETTING


The study utilized longitudinal data following 137 maltreating and low-income nonmaltreating mother-child dyads (M age  = 9.08, SD = 1.88; 54.7% Male).
METHODS


Mother-child dyads engaged in a randomized controlled trial of the Reminiscing and Emotion Training (RET; Valentino et al., 2019) intervention prior to the pandemic. Dyads discussed shared, past emotional experiences, and during the pandemic, mothers reported on their family resources and their child's internalizing symptoms. A path analysis examined the effects of family resources, race, maltreatment, and the RET intervention on child internalizing symptoms.
RESULTS


Family resources during the pandemic were significantly and inversely associated with child internalizing symptoms, b = -0.07, SE = 0.02, p < .01. There was a significant indirect effect of RET on child internalizing symptoms through sensitive reminiscing and a prior assessment of child maladjustment (95% CI [-0.294, -0.001]).
CONCLUSIONS


These findings suggest adequate family resources and sensitive maternal emotion socialization may be protective against child internalizing symptoms during the pandemic.",2021,"RESULTS


Family resources during the pandemic were significantly and inversely associated with child internalizing symptoms, b = -0.07, SE = 0.02, p < .01.","['Mother-child dyads', 'Child internalizing symptoms during the COVID-19 pandemic among maltreating and non-maltreating families', '137 maltreating and low-income nonmaltreating mother-child dyads (M age \xa0=\xa09.08, SD\xa0=\xa01.88; 54.7% Male']","['Reminiscing and Emotion Training', 'RET intervention', 'RET', 'Reminiscing and Emotion Training intervention']",['child internalizing symptoms'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191374', 'cui_str': '1.88'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0841933,"RESULTS


Family resources during the pandemic were significantly and inversely associated with child internalizing symptoms, b = -0.07, SE = 0.02, p < .01.","[{'ForeName': 'Brigid', 'Initials': 'B', 'LastName': 'Behrens', 'Affiliation': 'University of Notre Dame, USA. Electronic address: bbehren1@nd.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Edler', 'Affiliation': 'University of Notre Dame, USA.'}, {'ForeName': 'Kreila', 'Initials': 'K', 'LastName': 'Cote', 'Affiliation': 'University of Notre Dame, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Valentino', 'Affiliation': 'University of Notre Dame, USA.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.105375']
2472,34749994,High-dose steroids in high pain responders undergoing total knee arthroplasty: a randomised double-blind trial.,"BACKGROUND


Total knee arthroplasty (TKA) is associated with moderate-to-severe postoperative pain despite multimodal opioid-sparing analgesia. Pain catastrophising or preoperative opioid therapy is associated with increased postoperative pain. Preoperative glucocorticoid improves pain after TKA, but dose-finding studies and benefit in high pain responders are lacking.
METHODS


A randomised double-blind controlled trial with preoperative high-dose intravenous dexamethasone 1 mg kg -1  or intermediate-dose dexamethasone 0.3 mg kg -1  in 88 patients undergoing TKA with preoperative pain catastrophising score >20 or regular opioid use was designed. The primary outcome was the proportion of patients experiencing moderate-to-severe pain (VAS >30) during a 5 m walk 24 h postoperatively. Secondary outcomes included pain at rest during nights and at passive leg raise, C-reactive protein, opioid use, quality of sleep, Quality of Recovery-15 and Opioid-Related Symptom Distress Scale, readmission, and complications.
RESULTS


Moderate-to-severe pain when walking 24 h postoperatively was reduced (high dose vs intermediate dose, 49% vs 79%; P<0.01), along with pain at leg raise at 24 and 48 h (14% vs 29%, P=0.02 and 12% vs 31%, P=0.03, respectively). C-reactive protein was reduced in the high-dose group at both 24 and 48 h (both P<0.01). Quality of Recovery-15 was also improved (P<0.01).
CONCLUSIONS


When compared with preoperative dexamethasone 0.3 mg kg -1  i.v., dexamethasone 1 mg kg -1  reduced moderate-to-severe pain 24 h after TKA and improved recovery in high pain responders without apparent side-effects.
CLINICAL TRIAL REGISTRATION


NCT03763734.",2021,C-reactive protein was reduced in the high-dose group at both 24 and 48 h (both P<0.01).,"['high pain responders undergoing total knee arthroplasty', '88 patients undergoing TKA with preoperative pain catastrophising score >20 or regular opioid use was designed']","['Preoperative glucocorticoid', 'High-dose steroids', 'Total knee arthroplasty (TKA', 'preoperative high-dose intravenous dexamethasone 1 mg kg -1  or intermediate-dose dexamethasone', 'preoperative dexamethasone', 'dexamethasone', 'Pain catastrophising or preoperative opioid therapy']","['proportion of patients experiencing moderate-to-severe pain', 'pain at rest during nights and at passive leg raise, C-reactive protein, opioid use, quality of sleep, Quality of Recovery-15 and Opioid-Related Symptom Distress Scale, readmission, and complications', 'moderate-to-severe pain', 'pain at leg raise', 'C-reactive protein', 'Quality of Recovery-15', 'Moderate-to-severe pain', 'postoperative pain']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0985344', 'cui_str': 'Dexamethasone 1 MG'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",88.0,0.755816,C-reactive protein was reduced in the high-dose group at both 24 and 48 h (both P<0.01).,"[{'ForeName': 'Niklas I', 'Initials': 'NI', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesiology, Copenhagen University, Hvidovre Hospital, Copenhagen, Denmark. Electronic address: Niklas.Ingemann.Nielsen@regionh.dk.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Section of Surgical Pathophysiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Gromov', 'Affiliation': 'Department of Orthopaedic Surgery, Copenhagen University, Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopaedic Surgery, Copenhagen University, Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Husted', 'Affiliation': 'Department of Orthopaedic Surgery, Copenhagen University, Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Varnum', 'Affiliation': 'Department of Orthopaedic Surgery, Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kjærsgaard-Andersen', 'Affiliation': 'Department of Orthopaedic Surgery, Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Lasse E', 'Initials': 'LE', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Orthopaedic Surgery, Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Pleckaitiene', 'Affiliation': 'Department of Anaesthesiology, Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Nicolai B', 'Initials': 'NB', 'LastName': 'Foss', 'Affiliation': 'Department of Anaesthesiology, Copenhagen University, Hvidovre Hospital, Copenhagen, Denmark.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.10.001']
2473,34749983,Corrigendum to: Early enteral feeding versus traditional feeding in neonatal congenital gastrointestinal malformation undergoing intestinal anastomosis: A Randomized Multicenter Controlled Trial of an Enhanced Recovery after Surgery (ERAS) Component [J Pediatr Surg 2021 Sep; 56 (9): 1479-1484].,,2021,,['neonatal congenital gastrointestinal malformation undergoing intestinal anastomosis'],"['enteral feeding versus traditional feeding', 'Enhanced Recovery after Surgery (ERAS) Component [J Pediatr Surg 2021']",[],"[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0012241', 'cui_str': 'Congenital anomaly of gastrointestinal tract'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",[],,0.102563,,"[{'ForeName': 'Yanfen', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Xiao', 'Affiliation': ""Department of General Surgery, Shenzhen Children's Hospital, Shenzhen, China.""}, {'ForeName': 'Shangjie', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': ""Department of Neonatal Surgery, Guangdong Women and Children's Hospital, Guangdong, China.""}, {'ForeName': 'Liucheng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Zhujiang Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""Guangzhou Women and Children's Medical Center, Institute of Pediatrics, Guangzhou, China.""}, {'ForeName': 'Qiuming', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Haozhong', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of General Surgery, Shenzhen Children's Hospital, Shenzhen, China.""}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Neonatal Surgery, Guangdong Women and Children's Hospital, Guangdong, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Jiakang', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China. Electronic address: jiakangyu@hotmail.com.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2021.09.045']
2474,34750317,Liposomal Bupivacaine Suspension for Pain Control Following Ocular Evisceration Surgery.,"PURPOSE


To determine the effectiveness of retrobulbar liposomal bupivacaine for controlling postoperative pain following evisceration, compared with 0.75% bupivacaine.
METHODS


Randomized controlled trial, in which the postoperative pain scores from 24 patients who had retrobulbar liposomal bupivacaine after an evisceration were compared with the pain scores from 24 patients eviscerated using 0.75% bupivacaine.
RESULTS


Patients who received liposomal bupivacaine reported significantly less pain at 24 hours (2.0 out of 10, p = 0.01) and 48 hours (2.2 out of 10, p = 0.01) after surgery than patients who received 0.75% bupivacaine (5.7, and 5.0, respectively). The postoperative pain scores at 1 hour and at 7 days did not significantly differ between the 2 groups. Significantly, fewer patients who received liposomal bupivacaine (0%) than patients who received 0.75% bupivacaine (16.7%) returned emergently during the postoperative period for uncontrolled pain (p ≤ 0.001).
CONCLUSIONS


Retrobulbar liposomal bupivacaine is more effective than 0.75% bupivacaine for controlling pain during the first 2 days after evisceration and should be considered for patients undergoing this procedure.",2021,"Significantly, fewer patients who received liposomal bupivacaine (0%) than patients who received 0.75% bupivacaine (16.7%) returned emergently during the postoperative period for uncontrolled pain (p ≤ 0.001).
","['patients undergoing this procedure', '24 patients who had']","['liposomal bupivacaine', 'retrobulbar liposomal bupivacaine', 'Retrobulbar liposomal bupivacaine', 'bupivacaine', 'Liposomal Bupivacaine Suspension']","['postoperative pain scores', 'controlling pain', 'Pain Control', 'pain', 'pain scores', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0459804', 'cui_str': 'Retrobulbar space'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.200442,"Significantly, fewer patients who received liposomal bupivacaine (0%) than patients who received 0.75% bupivacaine (16.7%) returned emergently during the postoperative period for uncontrolled pain (p ≤ 0.001).
","[{'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Cox', 'Affiliation': 'Alabama Ophthalmology Associates, Birmingham, Alabama, U.S.A. University of Alabama, Birmingham, Alabama, U.S.A. Alabama Oculoplastic Surgery, Huntsville, Alabama, U.S.A.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Vicinanzo', 'Affiliation': ''}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Jacobs', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scruggs', 'Affiliation': ''}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': ''}]",Ophthalmic plastic and reconstructive surgery,['10.1097/IOP.0000000000002060']
2475,34750291,"Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV: a randomized phase 3 study.","OBJECTIVES


To evaluate safety and immunogenicity of V114 (15-valent pneumococcal conjugate vaccine [PCV] containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9 V, 14, 18C, 19A, 19F, 22F, 23F, and 33F), followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in adults living with HIV.
DESIGN


In this phase 3 study (V114-018; NCT03480802), pneumococcal vaccine-naive adults with HIV (CD4+ count ≥50 cells/μl, plasma HIV RNA < 50 000 copies/ml, receiving antiretroviral therapy) were randomized 1:1 to receive one dose of V114 or licensed 13-valent PCV (PCV13) on Day 1; participants received PPSV23 at Week 8.
METHODS


Adverse events (AEs) and serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) antibodies were evaluated after each vaccination.
RESULTS


Of 302 participants enrolled, 292 (96.7%) completed the study. Proportions of participants experiencing ≥1 AE were 73.0% and 62.7% in the V114 and PCV13 groups following PCV and 60.7% and 71.6% following PPSV23. Most solicited AEs were of mild or moderate severity and short duration. OPA geometric mean titers (GMTs) and IgG geometric mean concentrations (GMCs) were generally comparable between groups for shared serotypes at Day 30 and maintained at Week 12. OPA and IgG responses for additional serotypes in V114 (22F, 33F) were higher following V114 than PCV13 at Day 30 but comparable at Week 12, 30 days post-PPSV23.
CONCLUSIONS


In pneumococcal vaccine-naive adults living with HIV, V114 was well tolerated and induced immune responses for all 15 pneumococcal serotypes. V114 can be followed by PPSV23 8 weeks later to broaden serotype coverage.",2021,"OPA and IgG responses for additional serotypes in V114 (22F, 33F) were higher following V114 than PCV13 at Day 30 but comparable at Week 12, 30 days post-PPSV23.
","['naive adults with HIV (CD4+ count ≥50\u200acells/μl, plasma HIV RNA\u200a<\u200a50 000\u200acopies/ml, receiving antiretroviral therapy', '302 participants enrolled, 292 (96.7%) completed the study', 'adults living with HIV']","['PPSV23 at Week 8', 'V114 or licensed 13-valent PCV (PCV13', 'pneumococcal vaccine', 'V114 (15-valent pneumococcal conjugate vaccine [PCV', '15-valent pneumococcal conjugate vaccine']","['OPA and IgG responses', 'Adverse events (AEs) and serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) antibodies', 'tolerated and induced immune responses', 'OPA geometric mean titers (GMTs) and IgG geometric mean concentrations (GMCs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0947642', 'cui_str': 'Pneumovax 23'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine'}, {'cui': 'C1579319', 'cui_str': 'Pneumococcal conjugate vaccine'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",302.0,0.202074,"OPA and IgG responses for additional serotypes in V114 (22F, 33F) were higher following V114 than PCV13 at Day 30 but comparable at Week 12, 30 days post-PPSV23.
","[{'ForeName': 'Lerato', 'Initials': 'L', 'LastName': 'Mohapi', 'Affiliation': 'University of the Witwatersrand, Johannesburg, South Africa Hospital Nacional Arzobispo Loayza, Lima, Peru Triple O Research Institute, West Palm Beach, Florida, USA Chiang Mai University, Chiang Mai, Thailand Siriraj Hospital, Mahidol University, Bangkok, Thailand Assistance Publique Hopitaux de Paris, Paris, France Ben-Gurion University, Beer-Sheva, Israel Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Yvett', 'Initials': 'Y', 'LastName': 'Pinedo', 'Affiliation': ''}, {'ForeName': 'Olayemi', 'Initials': 'O', 'LastName': 'Osiyemi', 'Affiliation': ''}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': ''}, {'ForeName': 'Winai', 'Initials': 'W', 'LastName': 'Ratanasuwan', 'Affiliation': ''}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': ''}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Dagan', 'Affiliation': ''}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Tamms', 'Affiliation': ''}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Sterling', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Pedley', 'Affiliation': ''}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hartzel', 'Affiliation': ''}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Kan', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hurtado', 'Affiliation': ''}, {'ForeName': 'Luwy', 'Initials': 'L', 'LastName': 'Musey', 'Affiliation': ''}, {'ForeName': 'Jakub K', 'Initials': 'JK', 'LastName': 'Simon', 'Affiliation': ''}, {'ForeName': 'Ulrike K', 'Initials': 'UK', 'LastName': 'Buchwald', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000003126']
2476,34750197,PROPER-PRehabilitatiOn Plus Enhanced Recovery after surgery versus enhanced recovery after surgery in gynecologic oncology: a randomized clinical trial.,"BACKGROUND


Prehabilitation is a process that occurs before surgery and aims to improve patient functional capacity and enhance surgical recovery. This process includes medical, nutritional, physical, and psychological interventions that may reduce the duration of hospital stay and provide postoperative physical benefits.
PRIMARY OBJECTIVE


To evaluate the impact of a prehabilitation program on postoperative recovery time for patients who will undergo gynecological surgery following the Enhanced Recovery After Surgery (ERAS) guidelines.
STUDY HYPOTHESIS


A multidisciplinary, preoperative prehabilitation program for patients who will undergo gynecological surgery leads to a reduction in the length of hospital stay and improves patient functional capacity.
TRIAL DESIGN


Prospective, interventionist, and randomized controlled trial in a 1:1 ratio, open to multidisciplinary team and patients, blinded to surgeons and anesthesiologists. The control group will undergo ERAS standard preoperative care while the intervention group will have ERAS standard preoperative care plus prehabilitation.
MAJOR INCLUSION CRITERIA


Patients scheduled to undergo gynecologic surgery performed by laparotomy with a preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks.
PRIMARY ENDPOINT


To compare time between surgery and the day the patient is ready for discharge in patients who underwent the prehabilitation process versus those who did not. Readiness for discharge is defined as the ability to take care of one's-self, to walk alone, and to ingest at least 75% of daily recommended calorie intake.
SAMPLE SIZE


194 participants ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: At present, 30 patients have been recruited. Accrual should be completed by 2023-24.
TRIAL REGISTRATION


The study is approved by the IBCC - São Camilo Oncologia ethics committee (reference number 4.256.553) and is registered at clinicaltrials.gov (NCT04596800).",2021,"STUDY HYPOTHESIS


A multidisciplinary, preoperative prehabilitation program for patients who will undergo gynecological surgery leads to a reduction in the length of hospital stay and improves patient functional capacity.
","['patients who will undergo gynecological surgery leads to a reduction in the length of hospital stay and improves patient functional capacity', '194 participants', '30 patients have been recruited', 'Patients scheduled to undergo gynecologic surgery performed by laparotomy with a preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks', 'patients who will undergo gynecological surgery following the Enhanced Recovery']","['prehabilitation program', 'ERAS standard preoperative care while the intervention group will have ERAS standard preoperative care plus prehabilitation']",['postoperative recovery time'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033061', 'cui_str': 'Preoperative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.252317,"STUDY HYPOTHESIS


A multidisciplinary, preoperative prehabilitation program for patients who will undergo gynecological surgery leads to a reduction in the length of hospital stay and improves patient functional capacity.
","[{'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'Departamento de Ginecologia, Sao Camilo Oncologia, Sao Paulo, Brazil andrelopes.cirurgia@gmail.com.'}, {'ForeName': 'Alayne Magalhães Trindade Domingues', 'Initials': 'AMTD', 'LastName': 'Yamada', 'Affiliation': 'Núcleo de Pesquisa e Ensino da Rede São Camilo, Sao Paulo, Brazil.'}, {'ForeName': 'Thais de Campos', 'Initials': 'TC', 'LastName': 'Cardenas', 'Affiliation': 'Centro Universitário São Camilo, Sao Paulo, Brazil.'}, {'ForeName': 'Jaqueline Nunes de', 'Initials': 'JN', 'LastName': 'Carvalho', 'Affiliation': 'Serviço de Nutrição e Dietética, São Camilo Oncologia, Sao Paulo, Brazil.'}, {'ForeName': 'Emília de Azevedo', 'Initials': 'EA', 'LastName': 'Oliveira', 'Affiliation': 'Equipe Multidisciplinar, São Camilo Oncologia, Sao Paulo, Brazil.'}, {'ForeName': 'Marina Elisa Ribeiro da', 'Initials': 'MERD', 'LastName': 'Silva', 'Affiliation': 'Equipe Multidisciplinar, São Camilo Oncologia, Sao Paulo, Brazil.'}, {'ForeName': 'Juliana Fenerich Mauri', 'Initials': 'JFM', 'LastName': 'Andrade', 'Affiliation': 'Núcleo de Pesquisa e Ensino da Rede São Camilo, Sao Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'de Souza Neto', 'Affiliation': 'Departamento de Anestesiologia, Sao Camilo Oncologia, Sao Paulo, Brazil.'}, {'ForeName': 'Lilian Arruda do Rêgo', 'Initials': 'LADR', 'LastName': 'Barros', 'Affiliation': 'Núcleo de Pesquisa e Ensino da Rede São Camilo, Sao Paulo, Brazil.'}, {'ForeName': 'Ronaldo Lúcio Rangel', 'Initials': 'RLR', 'LastName': 'Costa', 'Affiliation': 'Departamento de Ginecologia, Sao Camilo Oncologia, Sao Paulo, Brazil.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2021-003170']
2477,34750613,Author response to: Shortening surgical training through robotics: randomized clinical trial of laparoscopic versus robotic surgical learning curves.,,2021,,[],['laparoscopic versus robotic surgical learning curves'],[],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",[],,0.139051,,"[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': 'The Royal Marsden Hospital, Department of Surgery and Cancer, Imperial College, London, UK.'}, {'ForeName': 'Tamara M H', 'Initials': 'TMH', 'LastName': 'Gall', 'Affiliation': 'The Royal Marsden Hospital, Department of Surgery and Cancer, Imperial College, London, UK.'}]",BJS open,['10.1093/bjsopen/zrab031']
2478,34750564,Acute effects of alcohol on social and personal decision making.,"Social drinking is common, but it is unclear how moderate levels of alcohol influence decision making. Most prior studies have focused on adverse long-term effects on cognitive and executive function in people with alcohol use disorders (AUD). Some studies have investigated the acute effects of alcohol on decision making in healthy people, but have predominantly used small samples and focused on a narrow selection of tasks related to personal decision making, e.g., delay or probability discounting. Here, we conducted a large (n = 264), preregistered randomized placebo-controlled study (RCT) using a parallel group design, to systematically assess the acute effects of alcohol on measures of decision making in both personal and social domains. We found a robust effect of a 0.6 g/kg dose of alcohol on both moral judgment and altruistic behavior, but no effects on several measures of risk taking or waiting impulsivity. These findings suggest that alcohol at low to moderate doses selectively moderates decision making in the social domain, and promotes utilitarian decisions over those dictated by rule-based ethical principles (deontological). This is consistent with existing theory that emphasizes the dual roles of shortsighted information processing and salient social cues in shaping decisions made under the influence of alcohol. A better understanding of these effects is important to understand altered social functioning during alcohol intoxication.",2021,"We found a robust effect of a 0.6 g/kg dose of alcohol on both moral judgment and altruistic behavior, but no effects on several measures of risk taking or waiting impulsivity.","['healthy people', 'people with alcohol use disorders (AUD']","['placebo-controlled study (RCT', 'alcohol']","['cognitive and executive function', 'several measures of risk taking or waiting impulsivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}]",,0.00613181,"We found a robust effect of a 0.6 g/kg dose of alcohol on both moral judgment and altruistic behavior, but no effects on several measures of risk taking or waiting impulsivity.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Karlsson', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Biomedical and Clinical Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Persson', 'Affiliation': 'Department of Management and Engineering, Division of Economics, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Perini', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Biomedical and Clinical Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Yngve', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Biomedical and Clinical Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Biomedical and Clinical Sciences, Linköping University, 581 83, Linköping, Sweden. markus.heilig@liu.se.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Tinghög', 'Affiliation': 'Department of Management and Engineering, Division of Economics, Linköping University, 581 83, Linköping, Sweden.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01218-9']
2479,34750553,Fenebrutinib in H 1  antihistamine-refractory chronic spontaneous urticaria: a randomized phase 2 trial.,"Bruton's tyrosine kinase (BTK) is crucial for FcεRI-mediated mast cell activation and essential for autoantibody production by B cells in chronic spontaneous urticaria (CSU). Fenebrutinib, an orally administered, potent, highly selective, reversible BTK inhibitor, may be effective in CSU. This double-blind, placebo-controlled, phase 2 trial (EudraCT ID 2016-004624-35 ) randomized 93 adults with antihistamine-refractory CSU to 50 mg daily, 150 mg daily and 200 mg twice daily of fenebrutinib or placebo for 8 weeks. The primary end point was change from baseline in urticaria activity score over 7 d (UAS7) at week 8. Secondary end points were the change from baseline in UAS7 at week 4 and the proportion of patients well-controlled (UAS7 ≤ 6) at week 8. Fenebrutinib efficacy in patients with type IIb autoimmunity and effects on IgG-anti-FcεRI were exploratory end points. Safety was also evaluated. The primary end point was met, with dose-dependent improvements in UAS7 at week 8 occurring at 200 mg twice daily and 150 mg daily, but not at 50 mg daily of fenebrutinib versus placebo. Asymptomatic, reversible grade 2 and 3 liver transaminase elevations occurred in the fenebrutinib 150 mg daily and 200 mg twice daily groups (2 patients each). Fenebrutinib diminished disease activity in patients with antihistamine-refractory CSU, including more patients with refractory type IIb autoimmunity. These results support the potential use of BTK inhibition in antihistamine-refractory CSU.",2021,Bruton's tyrosine kinase (BTK) is crucial for FcεRI-mediated mast cell activation and essential for autoantibody production by B cells in chronic spontaneous urticaria (CSU).,"['2016-004624-35 ) randomized 93 adults with', 'refractory chronic spontaneous urticaria', 'patients with antihistamine-refractory CSU, including more patients with refractory type IIb autoimmunity', 'patients with type IIb autoimmunity and effects on IgG-anti-FcεRI']","['antihistamine-refractory CSU to 50\u2009mg daily, 150\u2009mg daily and 200\u2009mg twice daily of fenebrutinib or placebo', 'placebo', 'antihistamine']","['UAS7', 'Asymptomatic, reversible grade 2 and 3 liver transaminase elevations', 'urticaria activity score', 'disease activity', 'Fenebrutinib efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0051979', 'cui_str': 'Anti-Immunoglobulin G antibody'}]","[{'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",93.0,0.286887,Bruton's tyrosine kinase (BTK) is crucial for FcεRI-mediated mast cell activation and essential for autoantibody production by B cells in chronic spontaneous urticaria (CSU).,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Metz', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sussman', 'Affiliation': ""Division of Allergy and Clinical Immunology, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Gagnon', 'Affiliation': ""Service d'Allergie et Immunologie, Département de Médecine, Centre Hospitalier Universitaire de Québec, Quebec City, Québec, Canada.""}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Staubach', 'Affiliation': 'Department of Dermatology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Tonny', 'Initials': 'T', 'LastName': 'Tanus', 'Affiliation': 'Kern Allergy Medical Clinic Inc., Bakersfield, CA, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Lim', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Holly J', 'Initials': 'HJ', 'LastName': 'Clarke', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Galanter', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Leslie W', 'Initials': 'LW', 'LastName': 'Chinn', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Chu', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Teterina', 'Affiliation': 'Hoffman-LaRoche Limited, Missisauga, Ontario, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Burgess', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'D James', 'Initials': 'DJ', 'LastName': 'Haddon', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Timothy T', 'Initials': 'TT', 'LastName': 'Lu', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany. marcus.maurer@charite.de.'}]",Nature medicine,['10.1038/s41591-021-01537-w']
2480,34750484,Renal and hepatic function of patients with severe tricuspid regurgitation undergoing inferior caval valve implantation.,"Due to progressive abdominal-venous congestion severe tricuspid regurgitation (TR) is a common cause of cardiorenal and cardiohepatic syndrome. We initiated the TRICAVAL study to compare interventional valve implantation into the inferior vena cava (CAVI) versus optimal medical therapy (OMT) in severe TR. In the present subanalysis, we aimed to evaluate the effects of CAVI on clinical signs of congestion, renal and hepatic function. TRICAVAL was an investigator-initiated, randomized trial. Twenty-eight patients with severe TR were randomized to OMT or CAVI using an Edwards Sapien XT valve. Probands who completed the 3-month follow-up (CAVI [n = 8], OMT [n = 10]) were evaluated by medical history, clinical examination, and laboratory testing at baseline, 3 and 12 months. After 3 months, the CAVI group exhibited a significant reduction of body weight (from 80.7 [69.0-87.7] kg to 75.5 [63.8-84.6] kg, p < 0.05) and abdominal circumference (from 101.5 ± 13.8 cm to 96.3 ± 15.4 cm, p ≤ 0.01) and a trend to lower doses of diuretics compared to OMT. Renal and hepatic function parameters did not change significantly. Within a short-term follow-up, CAVI led to an improvement of clinical signs of venous congestion and a non-significant reduction of diuretic doses compared to OMT.",2021,Renal and hepatic function parameters did not change significantly.,"['severe TR', 'Twenty-eight patients with severe TR', 'patients with severe tricuspid regurgitation undergoing inferior caval valve implantation', 'progressive abdominal-venous congestion severe tricuspid regurgitation (TR']","['interventional valve implantation into the inferior vena cava (CAVI) versus optimal medical therapy (OMT', 'CAVI', 'OMT or CAVI']","['Renal and hepatic function', 'Renal and hepatic function parameters', 'body weight', 'clinical signs of congestion, renal and hepatic function', 'abdominal circumference']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0042484', 'cui_str': 'Passive congestion'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0042458', 'cui_str': 'Inferior vena cava structure'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0085979', 'cui_str': 'Genus Cavia'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0700148', 'cui_str': 'Congestion'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}]",28.0,0.0276249,Renal and hepatic function parameters did not change significantly.,"[{'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hewing', 'Affiliation': 'Corporate Member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Medizinische Klinik Mit Schwerpunkt Kardiologie und Angiologie, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mattig', 'Affiliation': 'Corporate Member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Medizinische Klinik Mit Schwerpunkt Kardiologie und Angiologie, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Knebel', 'Affiliation': 'Corporate Member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Medizinische Klinik Mit Schwerpunkt Kardiologie und Angiologie, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Stangl', 'Affiliation': 'Corporate Member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Medizinische Klinik Mit Schwerpunkt Kardiologie und Angiologie, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Laule', 'Affiliation': 'Corporate Member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Medizinische Klinik Mit Schwerpunkt Kardiologie und Angiologie, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Stangl', 'Affiliation': 'Corporate Member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Medizinische Klinik Mit Schwerpunkt Kardiologie und Angiologie, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Dreger', 'Affiliation': 'Corporate Member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Medizinische Klinik Mit Schwerpunkt Kardiologie und Angiologie, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany. henryk.dreger@charite.de.'}]",Scientific reports,['10.1038/s41598-021-01322-2']
2481,34750450,The effects of bathing in neutral bicarbonate ion water.,"Percutaneously absorbed carbon dioxide enhances blood flow. The mechanism by which it does so is unclear, but we hypothesized that it involves bicarbonate ions. BALB/c mice were bathed in neutral bicarbonate ionized water (NBIW) and showed increased blood bicarbonate levels and blood flow via phosphorylation of peripheral vascular endothelial nitric oxide synthase (eNOS) and production of nitric oxide (NO). Phosphorylation of eNOS and NO production were also increased in human umbilical vein endothelial cells cultured in medium containing NBIW, and NBIW showed reactive oxygen species scavenging activity. In a double-blind, randomized study in men and women aged 30 to 59 years with subjective cold intolerance, bathing in NBIW elevated body temperature faster than bathing in a control solution and improved chills and sleep quality. Taken together, our results show that percutaneously absorbed carbon dioxide changes to bicarbonate ions, which act directly on endothelial cells to increase NO production by phosphorylation of eNOS and thus improve blood flow.",2021,"Phosphorylation of eNOS and NO production were also increased in human umbilical vein endothelial cells cultured in medium containing NBIW, and NBIW showed reactive oxygen species scavenging activity.","['men and women aged 30 to 59\xa0years with subjective cold intolerance, bathing in NBIW elevated body temperature faster than bathing in a control solution and improved chills and sleep quality']",['Percutaneously absorbed carbon dioxide'],"['blood bicarbonate levels and blood flow via phosphorylation of peripheral vascular endothelial nitric oxide synthase (eNOS) and production of nitric oxide (NO', 'blood flow']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009269', 'cui_str': 'Intolerant of cold'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0729819', 'cui_str': 'Blood bicarbonate measurement'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]",,0.044002,"Phosphorylation of eNOS and NO production were also increased in human umbilical vein endothelial cells cultured in medium containing NBIW, and NBIW showed reactive oxygen species scavenging activity.","[{'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Pathology, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, 230-8501, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Ushikoshi-Nakayama', 'Affiliation': 'Department of Pathology, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, 230-8501, Japan.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Shakya', 'Affiliation': 'Department of Pathology, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, 230-8501, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Omagari', 'Affiliation': 'Department of Pathology, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, 230-8501, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Pathology, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, 230-8501, Japan.'}, {'ForeName': 'Chiyoko', 'Initials': 'C', 'LastName': 'Nukuzuma', 'Affiliation': 'THERMOCELL Clinic, Tokyo Design Center 2F, 5-25-19 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Komatsu', 'Affiliation': 'Kanagawa Dental University Graduate School of Dental Medicine, Yokosuka-Shonan Disaster Oral Health Research Center & Oxidative Stress/ESR Laboratories, 82 Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan.'}, {'ForeName': 'Masaichi Chang-Il', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Kanagawa Dental University Graduate School of Dental Medicine, Yokosuka-Shonan Disaster Oral Health Research Center & Oxidative Stress/ESR Laboratories, 82 Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Inoue', 'Affiliation': 'Department of Pharmaceutical Sciences, Nihon Pharmaceutical University, 10281 Komuro, Ina-machi, Kitaadachi-gun, Saitama, 362-0806, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Saito', 'Affiliation': 'Department of Pathology, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, 230-8501, Japan. saito-i@tsurumi-u.ac.jp.'}]",Scientific reports,['10.1038/s41598-021-01285-4']
2482,34750443,Turn taking is not restricted by task specialisation but does not facilitate equality in offspring provisioning.,"Sexual conflict arises when two individuals invest in their common offspring because both individuals benefit when their partner invests more. Conditional cooperation is a theoretical concept that could resolve this conflict. Here, parents are thought to motivate each other to contribute to provisioning visits by following the rules of turn taking, which results in equal and efficient investment. However, parents have other tasks besides provisioning, which might hinder taking turns. To investigate restrictions by other care tasks and whether turn taking can be used to match investment, we manipulated brooding duration in female blue tits (Cyanistes caeruleus) during the early nestling phase by changing nest box temperature. As expected, females subjected to cold conditions brooded longer than females under warm conditions. Yet, contrary to our prediction, females had similar visit rates in both treatments, which suggests that females in the cold treatment invested more overall. In addition, the females' turn taking level was higher in the more demanding cold condition (and the calculated randomised turn taking levels of females did not differ), hence females don't seem to be restricted in their turn taking strategy by other care tasks. However, males did not seem to match the females' turn taking levels because they did not adjust their visit rates. Thus, level of turn taking was not restricted by an other sex-specific task in females and did not facilitate a greater investment by their male partners.",2021,"In addition, the females' turn taking level was higher in the more demanding cold condition (and the calculated randomised turn taking levels of females did not differ), hence females don't seem to be restricted in their turn taking strategy by other care tasks.",[],[],['visit rates'],[],[],[],,0.0682638,"In addition, the females' turn taking level was higher in the more demanding cold condition (and the calculated randomised turn taking levels of females did not differ), hence females don't seem to be restricted in their turn taking strategy by other care tasks.","[{'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Griffioen', 'Affiliation': 'Department of Biology, Behavioural Ecology and Ecophysiology Research Group, University of Antwerp, Wilrijk, Belgium. Maaike.griffioen@uantwerpen.be.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Iserbyt', 'Affiliation': 'Department of Biology, Behavioural Ecology and Ecophysiology Research Group, University of Antwerp, Wilrijk, Belgium.'}, {'ForeName': 'Wendt', 'Initials': 'W', 'LastName': 'Müller', 'Affiliation': 'Department of Biology, Behavioural Ecology and Ecophysiology Research Group, University of Antwerp, Wilrijk, Belgium.'}]",Scientific reports,['10.1038/s41598-021-01298-z']
2483,34750839,Effects of rocuronium dosage on intraoperative neurophysiological monitoring in patients undergoing spinal surgery.,"WHAT IS KNOWN AND OBJECTIVE


Intraoperative neurophysiological monitoring (IONM) has been widely used in clinical practice. Therefore, the influence of neuromuscular blockers essential for spinal anaesthesia on IONM is worthy of our attention, but no randomized study has evaluated the dose-response effect. This study investigated the effects of different doses of rocuronium bromide on the intraoperative monitoring of motor evoked potentials (MEPs).
METHODS


We conducted a randomized, double-blind trial to assess the effects of three rocuronium bromide doses (6.0, 9.0, 12 μg·kg -1  ·min -1  ) combined with intravenous infusion of propofol 6-8 mg·kg -1  ·h -1  and remifentanil 10 μg·kg -1  ·h -1  on the amplitudes of somatosensory evoked potentials (SEPs) and MEPs at the time of the baseline recording (T 1  ), before pedicle screw placement (T 2  ) and before spinal canal decompression (T 3  ). Secondary outcomes included measurement of neuromuscular function, the occurrence of unexpected intraoperative body movement and recovery of spontaneous breathing.
RESULTS AND DISCUSSION


A total of 123 patients were enrolled, and 120 patients were ultimately analysed. No differences were observed in the amplitude of SEPs among the three groups (p > 0.05). The MEP amplitude differences at T 1  , T 2  and T 3  in all limbs did not differ in patients receiving rocuronium at 6.0 μg·kg -1  ·min -1  and 9.0 μg·kg -1  ·min -1  (p > 0.05). However, when rocuronium was administered at 12.0 μg·kg -1  ·min -1  , MEP amplitudes at the time point T 3  were significantly attenuated compared with the time points T 1  and T 2  in both right upper limb and left lower limb (p = 0.002, p = 0.025, respectively). In patients treated with rocuronium 6.0 μg·kg -1  ·min -1  , the incidence of unexpected body movement was significantly higher (p = 0.026), and the train-of-four count (TOF count) showed a significant increase at T 2  and T 3  (p < 0.001) compared to other doses.
WHAT IS NEW AND CONCLUSION


Rocuronium bromide at a rate of 9.0 μg·kg -1  ·min -1  provided suitable and adequate muscle relaxation without inhibiting IONM; thus, this dose is recommended for spinal surgery.",2021,"The MEP amplitude differences at T 1  , T 2  and T 3  in all limbs did not differ in patients receiving rocuronium at 6.0 μg·kg -1  ·min -1  and 9.0 μg·kg -1  ·min -1  (p > 0.05).","['A total of 123 patients were enrolled, and 120 patients were ultimately analysed', 'patients undergoing spinal surgery']","['Rocuronium bromide', 'rocuronium bromide', 'rocuronium', 'propofol 6-8\xa0mg·kg -1  ·h -1  and remifentanil 10\xa0μg·kg -1  ·']","['incidence of unexpected body movement', 'intraoperative neurophysiological monitoring', 'amplitude of SEPs', 'measurement of neuromuscular function, the occurrence of unexpected intraoperative body movement and recovery of spontaneous breathing', 'amplitudes of somatosensory evoked potentials (SEPs) and MEPs', 'intraoperative monitoring of motor evoked potentials (MEPs']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0069632', 'cui_str': 'rocuronium bromide'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0430853', 'cui_str': 'Intraoperative neurophysiological monitoring'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0079637', 'cui_str': 'Intraoperative Monitoring'}]",123.0,0.254273,"The MEP amplitude differences at T 1  , T 2  and T 3  in all limbs did not differ in patients receiving rocuronium at 6.0 μg·kg -1  ·min -1  and 9.0 μg·kg -1  ·min -1  (p > 0.05).","[{'ForeName': 'Xueyong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Ruixu', 'Initials': 'R', 'LastName': 'Yan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Wanchao', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13557']
2484,34750775,The Implicit Sexual Risk Assessment: A Pilot Study of a Novel Behavioral Task.,"Risky sexual behaviors are a significant public health concern. Laboratory experiments are necessary to identify causal determinants of risky sexual behavior. However, experiments often rely on analogue sexual risk behavior, assessed by self-reported intentions in response to a sexual scenario. Using behavioral tasks to assess risk taking may be a valuable addition to self-reported intention outcome measures. The Balloon Analogue Risk Task (BART) is a commonly used measure of general risk-taking. However, BART's associations with sexual risk-taking have been mixed. In this pilot study, we developed a task akin to the BART, the Implicit Sexual Risk Assessment (ISRA), which incorporates sexual stimuli. We hypothesized sexual arousal would increase risk taking on ISRA relative to BART. Using a within-persons experimental design, 79 participants (52% women, mean age = 19.5 (SD = 1.42)) were randomized to condition (i.e., arousal versus neutral) and completed the BART and ISRA tasks. As expected, sexual arousal was associated with increased risk-taking (i.e., adjusted pumps) on ISRA relative to BART. However, this was unexpectedly the result of decreased pumps on BART instead of increased pumps on ISRA. Neither BART nor ISRA were significantly associated with sexual risk behavior or intentions. Null findings are qualified by the fact that sexual arousal was not significantly associated with sexual risk intentions.",2021,Neither BART nor ISRA were significantly associated with sexual risk behavior or intentions.,"['79 participants (52% women, mean age\u2009=\u200919.5 (SD\u2009=\u20091.42']",['Balloon Analogue Risk Task (BART'],"['Implicit Sexual Risk Assessment', 'Risky sexual behaviors', 'BART nor ISRA', 'Implicit Sexual Risk Assessment (ISRA', 'sexual risk behavior or intentions', 'sexual arousal']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0233972', 'cui_str': 'Sexual excitation'}]",79.0,0.0292252,Neither BART nor ISRA were significantly associated with sexual risk behavior or intentions.,"[{'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Walters', 'Affiliation': 'Department of Psychology, The University of South Dakota, 414 E Clark St, Vermillion, SD, 57069, USA. kyle.walters@coyotes.usd.edu.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Webb', 'Affiliation': 'Department of Psychology, The University of South Dakota, 414 E Clark St, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Simons', 'Affiliation': 'Department of Psychology, The University of South Dakota, 414 E Clark St, Vermillion, SD, 57069, USA.'}]",Archives of sexual behavior,['10.1007/s10508-021-02092-8']
2485,34750767,The Anti-inflammatory Effect of Dexmedetomidine Administration on Patients Undergoing Intestinal Surgery: A Randomized Study.,"BACKGROUND AND OBJECTIVE


Dexmedetomidine is a highly selective α2-adrenergic receptor agonist with sedative, analgesic, anti-sympathetic and stress-reducing effects. It has been widely used as an adjunct for general anesthesia of multiple surgeries. However, the relationship between the utilization of dexmedetomidine in intestinal surgery and the postoperative inflammatory response of patients remains unclear.
METHODS


A randomized, controlled, single-blinded clinical trial was performed. Eighty-six patients assigned for intestinal surgery were recruited and were randomly divided into two groups (dexmedetomidine group, n = 40; control group, n = 40) [six participants were excluded due to multiple reasons, such as allergy and drug use history]. The clinical characteristics and physiological outcomes of participants who received different treatments (dexmedetomidine and 0.9% sodium chloride) were collected and analyzed. Blood samples of the two groups were collected before administration (T0), 10 min after pumping dexmedetomidine/saline solution (T1), immediately after the operation started (T2), 30 min after the operation started (T3), and immediately after the operation ended (T4). Enzyme-linked immunosorbent assay (ELISA) was performed to evaluate the proinflammatory factors.
RESULTS


Intravenous injection of dexmedetomidine before intestinal surgery decreased a variety of circulating proinflammatory factors. Dexmedetomidine alleviated the stress response and promoted the recovery of cognitive ability among patients undergoing intestinal surgery.
CONCLUSION


Dexmedetomidine administration in patients undergoing intestinal surgery inhibited the surgery-induced inflammatory reactions.",2021,Intravenous injection of dexmedetomidine before intestinal surgery decreased a variety of circulating proinflammatory factors.,"['patients undergoing intestinal surgery inhibited the surgery-induced inflammatory reactions', 'patients undergoing intestinal surgery', 'Patients Undergoing Intestinal Surgery', 'participants who received different treatments ', 'Eighty-six patients assigned for intestinal surgery']","['Dexmedetomidine', 'dexmedetomidine', 'dexmedetomidine and 0.9% sodium chloride', 'dexmedetomidine/saline solution', 'dexmedetomidine group, n\xa0=\xa040; control group, n\xa0=\xa040) [six participants were excluded due to multiple reasons, such as allergy and drug use history', 'Enzyme-linked immunosorbent assay (ELISA']","['recovery of cognitive ability', 'stress response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",86.0,0.234555,Intravenous injection of dexmedetomidine before intestinal surgery decreased a variety of circulating proinflammatory factors.,"[{'ForeName': 'Rushuang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, Fujian, China.'}, {'ForeName': 'Zhenming', 'Initials': 'Z', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, Fujian, China. kzm991041@163.com.'}, {'ForeName': 'Yaduan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, Fujian, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, Fujian, China.'}, {'ForeName': 'Shunyuan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, Fujian, China. li767679@sina.com.'}]",Drugs in R&D,['10.1007/s40268-021-00368-x']
2486,34750747,The effect of pulse pressure variation compared with central venous pressure on intraoperative fluid management during kidney transplant surgery: a randomized controlled trial.,"BACKGROUND


Traditionally, fluid administration during kidney transplant surgery is guided by central venous pressure (CVP) despite its limited reliability as a parameter for assessing intravascular fluid volume, particularly in patients with cardiovascular diseases. The recommended goals at graft reperfusion are a mean arterial pressure of 90 mm Hg and a CVP of 12-14 mm Hg. This approach may increase the risk of significant adverse effects due to volume overload. Perioperative fluid therapy guided by dynamic indices of fluid responsiveness has been shown to optimize intravascular volume and prevent complications associated with overzealous administration of fluids in major abdominal surgeries. We hypothesized that pulse pressure variation (PPV)-guided fluid administration would result in better optimization of intravascular fluid volume compared with a CVP-guided strategy during kidney transplant surgery.
METHODS


In this single-centre randomized double blinded trial, 77 end-stage renal disease patients, who underwent kidney transplant surgery under general anesthesia with epidural analgesia, were randomized to receive either CVP-guided (n = 35) or PPV-guided (n = 35) fluid therapy using predefined hemodynamic endpoints. The primary outcome was the total volume of intraoperative fluids administered. Secondary outcomes were intraoperative hemodynamic changes, serum lactate levels, serum creatinine, need for dialysis within the first week, creatinine elimination ratio, and incidence of immediate and delayed graft dysfunction.
RESULTS


Results were analyzed for 70 patients. Eighty percent of the patients underwent living-related donor allograft kidney transplant. Operative variables related to donor characteristics, duration of surgery, graft cold ischemia time, and blood loss were comparable in both groups. The mean (standard deviation) volume of intravenous fluids administered intraoperatively was 1,346 (337) mL in the PPV-guided group vs 1,901 (379) mL in the CVP-guided group (difference in means, 556 mL; 95% confidence interval, 385 to 727; P = 0.001). There were no significant differences in secondary outcomes between the two groups.
CONCLUSION


Pulse pressure variation -guided fluid administration significantly decreased the total volume of crystalloids compared with CVP-guided fluid therapy during the intraoperative period in patients who underwent kidney transplant surgery. Nevertheless, our study was underpowered to detect differences in secondary outcomes.
TRIAL REGISTRATION


www.ctri.nic.in (CTRI/2018/01/011638); registered 31 January 2018.",2021,"There were no significant differences in secondary outcomes between the two groups.
","['77 end-stage renal disease patients, who underwent kidney transplant surgery under general anesthesia with epidural analgesia', 'patients with cardiovascular diseases', 'Eighty percent of the patients underwent living-related donor allograft kidney transplant', 'kidney transplant surgery', '70 patients', 'patients who underwent kidney transplant surgery']","['CVP-guided fluid therapy', 'central venous pressure', 'CVP-guided (n = 35) or PPV-guided (n = 35) fluid therapy', 'pulse pressure variation']","['total volume of crystalloids', 'intraoperative hemodynamic changes, serum lactate levels, serum creatinine, need for dialysis within the first week, creatinine elimination ratio, and incidence of immediate and delayed graft dysfunction', 'donor characteristics, duration of surgery, graft cold ischemia time, and blood loss', 'total volume of intraoperative fluids administered']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0564454', 'cui_str': 'Allograft kidney'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0428446', 'cui_str': 'Serum lactate measurement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1167870', 'cui_str': 'Transplant dysfunction'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C1563922', 'cui_str': 'Cold Ischemic Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",,0.418943,"There were no significant differences in secondary outcomes between the two groups.
","[{'ForeName': 'Gowtham', 'Initials': 'G', 'LastName': 'Kannan', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sekar', 'Initials': 'S', 'LastName': 'Loganathan', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Kajal', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India. kamal.kajal@gmail.com.'}, {'ForeName': 'Amarjyoti', 'Initials': 'A', 'LastName': 'Hazarika', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Indu Mohini', 'Initials': 'IM', 'LastName': 'Sen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Subramanyam', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Sarbpreet', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Kidney Transplant Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-021-02130-y']
2487,34750735,Gender Differences in Impacts of Place-Based Neighborhood Greening Interventions on Fear of Violence Based on a Cluster-Randomized Controlled Trial.,"Maintained green space in underserved urban neighborhoods may be an important environmental pathway to improving community health and safety, though effects may vary across population subgroups and by time of day. We examined survey responses from 442 participants (178 men and 264 women), living near vacant lots in a cluster-randomized controlled trial of a cleaning and greening intervention, on perceived safety during the day and at night. At the intervention sites after the intervention, only men reported feeling less unsafe during the day. Women reported more fear, and men reported less fear, after the intervention, although these results and tests for effect modification were not statistically significant. The clean-and-green intervention may have allayed fears for men during the day and supported their ease of movement throughout their neighborhoods. However, at night, it may have had the opposite effect on women. Though our study was under-powered, not designed to test associations stratified by gender, directions and magnitudes of associations differed substantially, indicating a need for further investigations into potential gender differences in the benefits of green space, to inform and better tailor interventions to improve perceived safety for all.",2021,"Women reported more fear, and men reported less fear, after the intervention, although these results and tests for effect modification were not statistically significant.","['442 participants (178 men and 264 women), living near vacant lots in a cluster-randomized controlled trial of a', 'underserved urban neighborhoods']","['cleaning and greening intervention', 'Neighborhood Greening Interventions']",['Fear of Violence'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}]","[{'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0042693', 'cui_str': 'Violence'}]",442.0,0.0880618,"Women reported more fear, and men reported less fear, after the intervention, although these results and tests for effect modification were not statistically significant.","[{'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Kondo', 'Affiliation': 'USDA Forest Service, Northern Research Station, Philadelphia, PA, USA. michelle.c.kondo@usda.gov.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Clougherty', 'Affiliation': 'Department of Environmental and Occupational Health, Drexel Dornsife School of Public Health, Philadelphia, PA, USA.'}, {'ForeName': 'Bernadette C', 'Initials': 'BC', 'LastName': 'Hohl', 'Affiliation': 'Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, NJ, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Branas', 'Affiliation': 'Department of Epidemiology, Columbia Mailman School of Public Health, New York, NY, USA.'}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-021-00580-9']
2488,34750707,Gender benefit in laparoscopic surgical performance using a 3D-display system: data from a randomized cross-over trial.,"BACKGROUND


The use of 3D technique compared to high-resolution 2D-4K-display technique has been shown to optimize spatial orientation and surgical performance in laparoscopic surgery. Since women make up an increasing amount of medical students and surgeons, this study was designed to investigate whether one gender has a greater benefit from using a 3D compared to a 4K-display system.
METHODS


In a randomized cross-over trial, the surgical performance of male and female medical students (MS), non-board certified surgeons (NBCS), and board certified surgeons (BCS) was compared using 3D- vs. 4K-display technique at a minimally invasive training parkour with multiple surgical tasks and repetitions.
RESULTS


128 participants (56 women, 72 men) were included. Overall parkour time in seconds was 3D vs. 4K for all women 770.7 ± 31.9 vs. 1068.1 ± 50.0 (p < 0.001) and all men 664.5 ± 19.9 vs. 889.7 ± 31.2 (p < 0.001). Regarding overall mistakes, participants tend to commit less mistakes while using the 3D-vision system, showing 10.2 ± 1.1 vs. 13.3 ± 1.3 (p = 0.005) for all women and 9.6 ± 0.7 vs. 12.2 ± 1.0 (p = 0.001) for all men. The benefit of using a 3D system, measured by the difference in seconds, was for women 297.3 ± 41.8 (27.84%) vs. 225.2 ± 23.3 (25.31%) for men (p = 0.005). This can be confirmed in the MS group with 327.6 ± 65.5 (35.82%) vs. 249.8 ± 33.7 (32.12%), p = 0.041 and in the NBCS group 359 ± 52.4 (28.25%) vs. 198.2 ± 54.2 (18.62%), p = 0.003. There was no significant difference in the BCS group.
CONCLUSION


3D laparoscopic display technique optimizes surgical performance compared to the 2D-4K technique for both women and men. The greatest 3D benefit was found for women with less surgical experience. As a possible result of surgical education, this gender specific difference disappears with higher grade of experience. Using a 3D-vision system could facilitate surgical apprenticeship, especially for women.",2021,3D laparoscopic display technique optimizes surgical performance compared to the 2D-4K technique for both women and men.,"['women with less surgical experience', 'women and men', 'male and female medical students (MS), non-board certified surgeons (NBCS), and board certified surgeons (BCS', '128 participants (56 women, 72 men) were included']","['2D-4K technique', '3D laparoscopic display technique optimizes surgical performance', '3D- vs. 4K-display technique at a minimally invasive training parkour with multiple surgical tasks and repetitions']",['Overall parkour time'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.134924,3D laparoscopic display technique optimizes surgical performance compared to the 2D-4K technique for both women and men.,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Busshoff', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Joseph-Stelzmann-Straße 9, 50931, Cologne, Germany.'}, {'ForeName': 'Rabi R', 'Initials': 'RR', 'LastName': 'Datta', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Joseph-Stelzmann-Straße 9, 50931, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Joseph-Stelzmann-Straße 9, 50931, Cologne, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kleinert', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Joseph-Stelzmann-Straße 9, 50931, Cologne, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Morgenstern', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pfister', 'Affiliation': 'Department of Urology, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Costanza', 'Initials': 'C', 'LastName': 'Chiapponi', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Joseph-Stelzmann-Straße 9, 50931, Cologne, Germany.'}, {'ForeName': 'Hans F', 'Initials': 'HF', 'LastName': 'Fuchs', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Joseph-Stelzmann-Straße 9, 50931, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Joseph-Stelzmann-Straße 9, 50931, Cologne, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gietzelt', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hedergott', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Desdemona', 'Initials': 'D', 'LastName': 'Möller', 'Affiliation': 'Department of Business Administration and Health Care Management, Faculty of Management, Economics and Social Sciences, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christiane J', 'Initials': 'CJ', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Joseph-Stelzmann-Straße 9, 50931, Cologne, Germany.'}, {'ForeName': 'Dirk L', 'Initials': 'DL', 'LastName': 'Stippel', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Joseph-Stelzmann-Straße 9, 50931, Cologne, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Wahba', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Joseph-Stelzmann-Straße 9, 50931, Cologne, Germany. roger.wahba@uk-koeln.de.'}]",Surgical endoscopy,['10.1007/s00464-021-08785-4']
2489,34750705,Comparative effectiveness of lidocaine sprays between sitting and supine position for patients undergoing upper gastrointestinal endoscopy: a prospective randomized controlled trial.,"BACKGROUND


Topical pharyngeal anesthesia has improved esophagogastroduodenoscopy (EGD) efficiency with smooth insertion, reducing pain and discomfort. Lidocaine spray is one of the safe and widely used methods. In practice, the patients walk, sit in a wheelchair, or lie on a trolley bed, and the lidocaine sprays are applied to those in sitting or supine positions for pre-endoscopic preparation. Although there is no current guidance technique, this study aims to compare the effects of lidocaine sprays between sitting (Group A; Gp A) and supine positions (Group B; Gp B) for patients undergoing unsedated EGD.
METHODS


This study was a single-center prospective randomized controlled trial. Unsedated EGD patients were randomly allocated the lidocaine spray in sitting or lidocaine spray in the supine position.
RESULTS


Lidocaine spray treatments were significantly different in the gag reflex (NRS; Gp A: 1.28 ± 0.67, Gp B: 1 ± 0.63, p = 0.0003), ease of esophageal instrumentation (NRS; Gp A: 7.68 ± 0.91, Gp B: 7.95 ± 0.66, p = 0.0042), and pain score (NRS; Gp A: 5.16 ± 2.08, Gp B: 4.53 ± 1.93, p = 0.0059). When considering modified Mallampati classification (MMC), MMC classes III and IV were significantly different in the same direction but MMC classes I and II were not.
CONCLUSION


The technique of spraying in the supine position was associated with less gagging, less pain, and easier esophageal instrumentation, especially in patients with MMC classes III and IV.",2021,"RESULTS


Lidocaine spray treatments were significantly different in the gag reflex (NRS; Gp A: 1.28 ± 0.67, Gp B: 1 ± 0.63, p = 0.0003), ease of esophageal instrumentation (NRS;","['patients undergoing upper gastrointestinal endoscopy', 'patients undergoing unsedated EGD', 'Unsedated EGD patients']","['lidocaine spray in sitting or lidocaine spray', 'lidocaine sprays', 'Lidocaine', 'lidocaine sprays between sitting and supine position', 'lidocaine', 'Lidocaine spray']","['gag reflex', 'gagging, less pain', 'pain and discomfort', 'pain score (NRS', 'ease of esophageal instrumentation (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}]",,0.0397038,"RESULTS


Lidocaine spray treatments were significantly different in the gag reflex (NRS; Gp A: 1.28 ± 0.67, Gp B: 1 ± 0.63, p = 0.0003), ease of esophageal instrumentation (NRS;","[{'ForeName': 'Prasit', 'Initials': 'P', 'LastName': 'Mahawongkajit', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 95/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand. prasit_md@yahoo.com.'}, {'ForeName': 'Neranchala', 'Initials': 'N', 'LastName': 'Soonthornkes', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Thammasat University, Pathumthani, Thailand.'}]",Surgical endoscopy,['10.1007/s00464-021-08868-2']
2490,34669181,Evaluation of Interfascial Plane and Pericapsular Nerve Blocks to the Shoulder Joint: A Preliminary Analysis of Shoulder Anterior Capsular Block.,"INTRODUCTION


The aim of this study is to verify if the shoulder anterior capsular block (SHAC), combined with other nerve blocks, is effective in relieving shoulder pain, avoiding motor block and allowing an early rehabilitation program.
METHODS


Seventy-five consecutive patients with painful shoulder were treated with the SHAC, alone (30 patients) or in combination with a suprascapular nerve block (SSnb: 25 patients) or with pectoralis and serratus plane block (PECS-2: 20 patients). All blocks were performed with 0.2% ropivacaine plus 8 mg dexamethasone. All patients were treated with three-weekly physiotherapy sessions for the following 2 weeks and then with home exercises.
RESULTS


The post-procedural analgesic effect was strong in all groups, with a mean change in numeric rating scale (NRS) values of -6.05 in group 1, -6.25 in group 2, and -6.19 in group 3 (p < .0001), allowing all patients to complete an immediate physiotherapy session. Only a few patients needed to repeat the procedure 1 week after the first treatment for the recurrence of pain. From the treatment to the end of the follow-up, we noted a further drop in mean pain NRS values of 1.90 in group 1 and 1.80 in groups 2 and 3. No difference in effect over time was observed among the different groups. No adverse event or motor block was recorded.
CONCLUSION


This study demonstrates that the SHAC, alone or in combination with other peripheral nerve blocks, is an attractive alternative for shoulder pain management, especially when physiotherapy is required to recover shoulder function.",2021,"The post-procedural analgesic effect was strong in all groups, with a mean change in numeric rating scale (NRS) values of -6.05 in group 1, -6.25 in group 2, and -6.19 in group 3 (p < .0001), allowing all patients to complete an immediate physiotherapy session.","['Seventy-five consecutive patients with painful shoulder', 'Shoulder Joint']","['shoulder anterior capsular block (SHAC), combined with other nerve blocks', 'ropivacaine', 'SHAC, alone (30 patients) or in combination with a suprascapular nerve block (SSnb: 25 patients) or with pectoralis and serratus plane block (PECS-2', 'dexamethasone', 'Interfascial Plane and Pericapsular Nerve Blocks']","['post-procedural analgesic effect', 'mean pain NRS values', 'recurrence of pain', 'adverse event or motor block', 'numeric rating scale (NRS) values']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",75.0,0.0138955,"The post-procedural analgesic effect was strong in all groups, with a mean change in numeric rating scale (NRS) values of -6.05 in group 1, -6.25 in group 2, and -6.19 in group 3 (p < .0001), allowing all patients to complete an immediate physiotherapy session.","[{'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Galluccio', 'Affiliation': 'MoMaRC Morphological Madrid Research Center, Madrid, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Fajardo Perez', 'Affiliation': 'MoMaRC Morphological Madrid Research Center, Madrid, Spain.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Yamak Altinpulluk', 'Affiliation': 'MoMaRC Morphological Madrid Research Center, Madrid, Spain.'}, {'ForeName': 'Jin-De', 'Initials': 'JD', 'LastName': 'Hou', 'Affiliation': 'Division of Anesthesiology, Hualien Armed Forces General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Jui-An', 'Initials': 'JA', 'LastName': 'Lin', 'Affiliation': 'Center for Regional Anesthesia and Pain Medicine, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan. juian.lin@tmu.edu.tw.'}]",Pain and therapy,['10.1007/s40122-021-00326-0']
2491,34741653,Delivering exercise medicine to cancer survivors: has COVID-19 shifted the landscape for how and who can be reached with supervised group exercise?,"PURPOSE


Due to stay-at-home orders during COVID-19, we transitioned supervised, group, in-person resistance training interventions in two clinical trials in cancer survivors to live, online delivery using video-conferencing technology. We describe the feasibility, preliminary efficacy, and safety of live online group training and compare to in-person training.
METHODS


Adherence (% sessions attended), retention (% participants completing intervention), and safety (# adverse events) data of resistance training groups from two randomized controlled trials in cancer survivors that participated before or during the COVID-19 pandemic were collated. Participants were post-treatment breast cancer survivors and their spouses (n = 62) and prostate cancer survivors (n = 32) (age range: 38-82 years). During COVID-19, delivery of supervised, group resistance exercise sessions was delivered live online via video-conference. Preliminary evidence for training efficacy was assessed by chair stand performance over the 6-month intervention.
RESULTS


Feasibility of online resistance training was better than in-person for both studies (adherence: 86% vs 82% and 91% vs. 81% and retention 95% vs. 80% and 92% vs. 84% for online and in-person classes). Improvements in chair stand time were similar in prostate cancer and spouse groups that trained online vs. in-person, except for breast cancer survivors who improved more with in-person training (7% vs. 14% for online vs. in-person). Safety was similar between formats (12 vs. 11 adverse events for online vs. in-person).
CONCLUSION


Supervised, in-person group resistance training can be feasibly adapted for live, online delivery and could help broaden approaches to exercise delivery in cancer survivors, including older adults.
TRIAL REGISTRATION


The studies described in this commentary were registered on ClinicalTrials.gov on August 3, 2018 (NCT03630354) and on October 30, 2018 (NCT03741335).",2021,"Improvements in chair stand time were similar in prostate cancer and spouse groups that trained online vs. in-person, except for breast cancer survivors who improved more with in-person training (7% vs. 14% for online vs. in-person).","['cancer survivors', 'Participants were post-treatment breast cancer survivors and their spouses (n\u2009=\u200962) and prostate cancer survivors (n\u2009=\u200932) (age range: 38-82\xa0years', 'cancer survivors, including older adults']","['live online group training', 'online resistance training']","['chair stand time', 'Safety']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0546777,"Improvements in chair stand time were similar in prostate cancer and spouse groups that trained online vs. in-person, except for breast cancer survivors who improved more with in-person training (7% vs. 14% for online vs. in-person).","[{'ForeName': 'Kerri M', 'Initials': 'KM', 'LastName': 'Winters-Stone', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, KCRB-CPC, 3455 SW US Veterans Hospital Road, Portland, OR, 97239, USA. wintersk@ohsu.edu.'}, {'ForeName': 'Cassie', 'Initials': 'C', 'LastName': 'Boisvert', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, KCRB-CPC, 3455 SW US Veterans Hospital Road, Portland, OR, 97239, USA.'}, {'ForeName': 'Fuzhong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Oregon Research Institute, Eugene, OR, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Lyons', 'Affiliation': 'Connell School of Nursing, Boston College, Boston, MA, USA.'}, {'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Beer', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, KCRB-CPC, 3455 SW US Veterans Hospital Road, Portland, OR, 97239, USA.'}, {'ForeName': 'Zahi', 'Initials': 'Z', 'LastName': 'Mitri', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, KCRB-CPC, 3455 SW US Veterans Hospital Road, Portland, OR, 97239, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Meyers', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, KCRB-CPC, 3455 SW US Veterans Hospital Road, Portland, OR, 97239, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Eckstrom', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, School of Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-021-06669-w']
2492,34741911,"Effects of an ethical decision-making reasoning scheme in nursing students: A randomized, open-label, controlled trial.","BACKGROUND


Previous research suggests that, to design a program to help students to develop ethical decision making, competence and courage to confront ethical dilemmas should be critical components.
PURPOSE


This study examines the effect of an ethical decision-making reasoning scheme in ethical decision making and communication self-efficacy in nursing students.
METHODS


This study was a prospective and randomized, open-label, controlled trial design. Nursing students from a medical university served as participants. Students were randomly assigned to an intervention group (IG), which received the ethical decision-making reasoning scheme intervention, or a control group (CG), which received a standard general course. The effect was measured with the Ethical Decision-Making Scale-Revised and the Self-efficacy for Communication Scale. Analysis of covariance (ANCOVA) was used to measure between-group differences, and paired t-tests were used to measure pre- and post-IG/CG differences.
RESULTS


A total of 101 nursing students were included and randomly assigned to the IG (n = 50) and CG (n = 51), and 41 IG and 43 CG students completed all aspects of the study. The findings show that there was significant improvement in self-efficacy in communication (t = 2.341, p = .024) and a decrease in difficulty in communication (t = 2.330, p = .025) in the IG. Ethical decision-making competencies improved more in the IG compared to the CG (F = 4.856, p = .034). Ethical decision-making competencies increased in both males and females, but there were no significant differences between males and females at the end of study (F = 0.264, p = .610).
CONCLUSION


These findings suggest that ethical decision-making training can improve students' confidence in communicating with patients and may help to improve students' more complex ethical decision making.",2021,"Ethical decision-making competencies improved more in the IG compared to the CG (F = 4.856, p = .034).","['nursing students', 'A total of 101 nursing students', 'Nursing students from a medical university served as participants']","['ethical decision-making reasoning scheme', 'CG', 'ethical decision-making reasoning scheme intervention, or a control group (CG']","['self-efficacy in communication', 'Ethical decision-making competencies', 'Ethical Decision-Making Scale-Revised and the Self-efficacy for Communication Scale', 'difficulty in communication']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",101.0,0.0207719,"Ethical decision-making competencies improved more in the IG compared to the CG (F = 4.856, p = .034).","[{'ForeName': 'Hsiang-Chu', 'Initials': 'HC', 'LastName': 'Pai', 'Affiliation': 'Department of Nursing, Chung-Shan Medical University, Taiwan, ROC; Chung-Shan Medical University Hospital, Taiwan, ROC. Electronic address: pai55215@ms41.hinet.net.'}, {'ForeName': 'Lien-Jen', 'Initials': 'LJ', 'LastName': 'Hwu', 'Affiliation': 'Department of Nursing, Chung-Shan Medical University, Taiwan, ROC. Electronic address: lienjen@csmu.edu.tw.'}, {'ForeName': 'Yen-Chiao', 'Initials': 'YC', 'LastName': 'Lu', 'Affiliation': 'Department of Nursing, Chung-Shan Medical University, Taiwan, ROC. Electronic address: angellu@csmu.edu.tw.'}, {'ForeName': 'Wen-Jiuan', 'Initials': 'WJ', 'LastName': 'Yen', 'Affiliation': 'Department of Nursing, Chung-Shan Medical University, Taiwan, ROC; Chung-Shan Medical University Hospital, Taiwan, ROC. Electronic address: wyen@csmu.edu.tw.'}]",Nurse education today,['10.1016/j.nedt.2021.105189']
2493,34741886,In vitro validation study of HER2 and HER4 mutations identified in an ad hoc secondary analysis of the LUX-Lung 8 randomized clinical trial.,"OBJECTIVES


The LUX-Lung 8 randomized trial (LL8) demonstrated a prolonged progression-free survival (PFS) in patients with metastatic squamous cell carcinoma (SCC) of the lung after treatment with afatinib compared with erlotinib. A secondary analysis of the LL8 reported that the presence of rare HER2/HER4 mutations may be partly responsible for this result. Patients with HER2 (hazard ratio [HR] 0.06/p-value 0.02) or HER4 (HR 0.21/p-value unreported) mutations had longer PFS after treatment with afatinib. However, the biological function of these mutations is unclear.
MATERIALS AND METHODS


Ten HER2 and 13 HER4 point mutations that were detected in the secondary analysis were transduced into the mouse pro-B cell line (Ba/F3) to determine changes in interleukin-3 (IL-3) dependence and sensitivity to six EGFR or pan-HER tyrosine kinase inhibitors (TKIs), including afatinib and erlotinib. The efficacy of the six TKIs was compared using a sensitivity index, defined as the 50% inhibitory concentration divided by trough concentration of each drug at clinically recommended doses.
RESULTS


Seven out of 10 Ba/F3 clones expressing HER2 mutations and all 13 Ba/F3 clones expressing HER4 mutations did not grow in the absence of IL-3, indicating these mutations were non-oncogenic. Three Ba/F3 clones expressing the HER2 mutations E395K, G815R, or R929W acquired IL-3-independent growth. The sensitivity indices for afatinib were ≤ one-fifth of those for erlotinib in all three lines. Other second/third-generation (2G/3G) TKIs showed high efficacy against clones expressing these HER2 mutations.
CONCLUSIONS


The majority of HER2/4 mutations detected in lung SCC from LL8 were not oncogenic in the Ba/F3 models, suggesting that the presence of HER2/4 mutations were not responsible for the superior outcomes of afatinib in the LL8 study. However, SCC of the lung in some patients may be driven by rare HER2 mutations, and these patients may benefit from 2G/3G pan-HER-TKI treatment.",2021,Patients with HER2 (hazard ratio [HR] 0.06/p-value 0.02) or HER4 (HR 0.21/p-value unreported),"['patients with metastatic squamous cell carcinoma (SCC) of the lung after treatment with afatinib compared with', 'Seven out of 10']",['erlotinib'],"['HER2 mutations', 'sensitivity indices', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.205128,Patients with HER2 (hazard ratio [HR] 0.06/p-value 0.02) or HER4 (HR 0.21/p-value unreported),"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Hamada', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan; Department of Surgery II, Yamagata University Faculty of Medicine, 2-2-2 Iida-Nishi, Yamagata 990-9585, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Suda', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.'}, {'ForeName': 'Takamasa', 'Initials': 'T', 'LastName': 'Koga', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Fujino', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Nishino', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.'}, {'ForeName': 'Shuta', 'Initials': 'S', 'LastName': 'Ohara', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Chiba', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Shimoji', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Takemoto', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Soh', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Uchida', 'Affiliation': 'Department of Surgery II, Yamagata University Faculty of Medicine, 2-2-2 Iida-Nishi, Yamagata 990-9585, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Mitsudomi', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan. Electronic address: mitsudom@med.kindai.ac.jp.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2021.10.014']
2494,34741827,Maintenance phase of a physical activity intervention in older kidney transplant recipients: A 12-month follow-up.,"Daily walking activities are associated with improving cardiovascular outcomes in older kidney transplant recipients. However, little is known regarding physical activity adherence outcomes in older kidney recipients. The purpose of this randomized controlled trial 12-month follow-up study was to evaluate the feasibility of the intervention (SystemCHANGE™ + activity tracker) during the maintenance period (7-12 months), compared to an attention-control group (activity tracker only) in older kidney recipients (age 60 and older). The sample included 60 participants (n = 30 IG; n = 30 ACG). Adherence rates for wearing the activity tracker daily were 96.5% in the IG and 80.8% in the ACG. The IG demonstrated within-group improvements for blood pressure at 12 months. Overall, there was a decrease in the average daily steps observed in both groups. These data suggest this intervention is feasible and additional boosters should be considered during the maintenance period to encourage physical activity.",2021,Adherence rates for wearing the activity tracker daily were 96.5% in the IG and 80.8% in the ACG.,"['older kidney transplant recipients', 'older kidney recipients', '60 participants (n\xa0=\xa030 IG; n\xa0=\xa030 ACG', 'older kidney recipients (age 60 and older']","['attention-control group (activity tracker only', 'intervention (SystemCHANGE™\xa0+\xa0activity tracker', 'physical activity intervention']","['cardiovascular outcomes', 'average daily steps', 'blood pressure', 'Adherence rates']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0050397', 'cui_str': 'acceleratory factor from growth hormone'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",60.0,0.0701799,Adherence rates for wearing the activity tracker daily were 96.5% in the IG and 80.8% in the ACG.,"[{'ForeName': 'Tara', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': 'The Ohio State University College of Nursing, Columbus, OH Columbus, OH, Newton Hall,1585 Neil Ave, Columbus, OH 43210, USA. Electronic address: obrien.782@osu.edu.'}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'The Ohio State University College of Nursing Newton Hall, 1585 Neil Ave, Columbus, OH, USA 43210.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'The Ohio State University College of Nursing Newton Hall, 1585 Neil Ave, Columbus, OH, USA 43210.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Focht', 'Affiliation': 'The Ohio State University College of Education and Human Ecology, 152 PAES, 305 Annie and John Glenn Ave, Columbus, OH, USA, 43210.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Daloul', 'Affiliation': 'The Ohio State University College of Medicine, 300 West 10th Avenue Suite 1150, Columbus, USA, OH 43210.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.08.019']
2495,34741779,PaRent InterventiOn to pRevent dIsordered eating in children with TYpe 1 diabetes (PRIORITY): Study protocol for a feasibility randomised controlled trial.,"AIMS


Increasing evidence suggests that children and young people with type 1 diabetes (T1D) are at greater risk of disordered eating compared to children without T1D. Disordered eating in T1D has been linked to impaired wellbeing, increased health service use and early mortality. To address this problem, we will co-develop a psycho-education intervention for parents of children and young people with T1D, informed by the Information Motivation Behavioural Skills model.
METHODS


The objective of this study is to assess the feasibility and acceptability of the intervention compared to a waitlist control group using a feasibility randomised controlled trial (RCT) design. We aim to recruit 70 parents of children and young people with T1D (11-14 years), 35 in each arm. Those assigned to the intervention will be invited to participate in two workshops of 2 h each. Parents will be asked to complete outcome measures regarding eating habits, diabetes management, as well as a questionnaire based on the Information Motivation Behavioural Skills model which provides a theoretical foundation for the intervention. These will be completed at baseline, 1- and 3-month post-intervention. Children and young people will be asked to complete questionnaires on their eating behaviours at the same time intervals. Parents randomised to receive the intervention will be invited to take part in interviews to feedback on the intervention and research protocol acceptability.
CONCLUSION


It is anticipated that the psycho-education intervention aimed at parents will help prevent the development of disordered eating in children and young people with T1D and improve parental wellbeing. The results of this feasibility trial will determine whether this intervention approach is acceptable to families living with T1D, and whether a definitive RCT of intervention effectiveness is justified. Qualitative findings will be used to refine the intervention and study protocols.
TRIAL REGISTRATION


This protocol has been registered with ClinicalTrials.gov [Identifier: NCT04741568].",2021,"The results of this feasibility trial will determine whether this intervention approach is acceptable to families living with T1D, and whether a definitive RCT of intervention effectiveness is justified.","['children and young people with type 1 diabetes (T1D', 'children with TYpe 1 diabetes (PRIORITY', 'Children and young people', '70 parents of children and young people with T1D (11-14 years), 35 in each arm', 'parents of children and young people with T1D']","['psycho-education intervention', 'PaRent InterventiOn']",['feasibility and acceptability'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0274458,"The results of this feasibility trial will determine whether this intervention approach is acceptable to families living with T1D, and whether a definitive RCT of intervention effectiveness is justified.","[{'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Jones', 'Affiliation': 'School of Psychology, University of Surrey, Guildford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': ""O'Donnell"", 'Affiliation': 'School of Psychology, University of Surrey, Guildford, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'John', 'Affiliation': 'School of Psychology, University of Surrey, Guildford, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Cooke', 'Affiliation': 'School of Health Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Stewart', 'Affiliation': 'Betsi Cadwaladr University Health Board, Wrexham, Wales, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Hale', 'Affiliation': 'School of Psychology, University of Surrey, Guildford, UK.'}, {'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Skene', 'Affiliation': 'Surrey Clinical Trials Unit, School of Biosciences and Medicine, University of Surrey, Guildford, UK.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Kanumakala', 'Affiliation': ""Royal Alexandra Children's Hospital, University Hospitals Sussex NHS Foundation Trust, Brighton, UK.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Harrington', 'Affiliation': 'School of Psychology, University of Surrey, Guildford, UK.'}, {'ForeName': 'Rose-Marie', 'Initials': 'RM', 'LastName': 'Satherley', 'Affiliation': 'School of Psychology, University of Surrey, Guildford, UK.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14738']
2496,34746655,Efficacy of orthopaedic-inspired osteoporosis management: a secondary fracture prevention program after a fracture of the hip in a prospective randomized study.,"Aims


Patients who present with fragility fractures are consistently under-evaluated and under-treated for underlying osteoporosis. This point-of-care represents a lost opportunity to prevent future fractures. This 2-arm study evaluated the success by an orthopaedic department in osteoporosis evaluation and initiating treatment.
Methods


Patients over the age of 50 years with a fragility fracture of the hip were candidates for inclusion. Exclusion criteria included end-of-life care and moderate or severe dementia. Patients were prospectively randomized into 1 of 2 groups. The Letter group received a letter at the time of discharge encouraging their primary care physician to start medication for osteoporosis (Letter group). The intervention group had 4 interventions including printed information, a DEXA scan, a specific treatment recommendation, and monthly phone calls for 4 months (Intervention group). The primary outcome measure was whether the patient was on recommended treatment at 4 months from the fracture.
Results


There were 200 patients in the study, 100 in the Letter, and 100 in the Intervention group. Sixteen patients were removed from the study since they either died (9) within 4 months of their fracture, were transferred for end-of-life care (7), and 4 dropped out. This left 180 patients for analysis. The Letter group had only 6 patients (6.2%) on recommended treatment compared with the Intervention group with 64 patients (77.1%). This was statistically significant ( P  < 0.0001).
Conclusion


Osteoporosis is a worldwide epidemic. Internationally, only about 20% of patients after a hip fracture are treated for their underlying weak bone. The most effective systems use a fracture liaison service (FLS) model. We present a 4-part intervention program that uses an FLS coordinator within the orthopaedic department. We encourage orthopaedic programs to adopt this or other models with the goal of taking the first step toward responsibility for bone health.An FLS program within an orthopaedic department can successfully initiate treatment for underlying osteoporosis.",2021,The Letter group had only 6 patients (6.2%) on recommended treatment compared with the Intervention group with 64 patients (77.1%).,"['200 patients in the study, 100 in the Letter, and 100 in the Intervention group', 'This left 180 patients for analysis', 'Methods\n\n\nPatients over the age of 50\u200ayears with a fragility fracture of the hip were candidates for inclusion', 'Sixteen patients were removed from the study since they either died (9) within 4\u200amonths of their fracture, were transferred for end-of-life care (7), and 4 dropped out', 'Exclusion criteria included end-of-life care and moderate or severe dementia']","['orthopaedic-inspired osteoporosis management', '4 interventions including printed information, a DEXA scan, a specific treatment recommendation, and monthly phone calls', 'letter at the time of discharge encouraging their primary care physician to start medication for osteoporosis (Letter group']",[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1292747', 'cui_str': 'Removes from'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia'}]","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],16.0,0.00744426,The Letter group had only 6 patients (6.2%) on recommended treatment compared with the Intervention group with 64 patients (77.1%).,"[{'ForeName': 'Gershon', 'Initials': 'G', 'LastName': 'Zinger', 'Affiliation': 'Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Sylvetsky', 'Affiliation': 'Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Yedin', 'Initials': 'Y', 'LastName': 'Levy', 'Affiliation': 'Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Kobi', 'Initials': 'K', 'LastName': 'Steinberg', 'Affiliation': 'Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bregman', 'Affiliation': 'Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Genady', 'Initials': 'G', 'LastName': 'Yudkevich', 'Affiliation': 'Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Peyser', 'Affiliation': 'Shaare Zedek Medical Center, Jerusalem, Israel.'}]",OTA international : the open access journal of orthopaedic trauma,['10.1097/OI9.0000000000000122']
2497,34747087,"Restrictive versus Liberal Transfusion in Patients with Diabetes Undergoing Cardiac Surgery: An Open-Label Randomized, Blinded Outcome Evaluation Trial.","AIM


To characterize the association between diabetes and transfusion and clinical outcomes in cardiac surgery, and to evaluate whether restrictive transfusion thresholds are harmful in these patients.
MATERIALS AND METHODS


The multinational, open-label, randomized controlled TRICS-III trial assessed a restrictive transfusion strategy (hemoglobin [Hb] transfusion threshold <75 g/L) compared to a liberal strategy (Hb <95 g/L for operating room or ICU; or < 85 g/L for ward) in patients undergoing cardiac surgery on cardiopulmonary bypass with a moderate-to-high risk of death (EuroSCORE ≥6). Diabetes status was collected preoperatively. The primary composite outcome was all-cause death, stroke, myocardial infarction, and new-onset renal failure requiring dialysis at 6 months. Secondary outcomes included components of the composite outcome at 6 months, and transfusion and clinical outcomes at 28 days.
RESULTS


Of the 5092 patients analyzed, 1396 (27.4%) had diabetes (Restrictive: n = 679, Liberal n = 717). Patients with diabetes had more cardiovascular disease than patients without diabetes. Neither the presence of diabetes (OR [95%CI]1.10[0.93-1.31]) or the restrictive strategy increased the risk for the primary composite outcome (diabetes OR [95%CI]1.04[0.68-1.59] vs. no diabetes OR 1.02[0.85-1.22],p interaction   = 0.92). In patients with versus without diabetes, a restrictive transfusion strategy was more effective at reducing red blood cell transfusion (diabetes OR [95%CI] 0.28[0.21-0.36]; no diabetes OR [95%CI] 0.40[0.35-0.47];p interaction   = 0.04).
CONCLUSIONS


The presence of diabetes did not modify the effect of a restrictive transfusion strategy on the primary composite outcome, but improved its efficacy on red cell transfusion. Restrictive transfusion triggers are safe and effective in patients with diabetes undergoing cardiac surgery. This article is protected by copyright. All rights reserved.",2021,"The presence of diabetes did not modify the effect of a restrictive transfusion strategy on the primary composite outcome, but improved its efficacy on red cell transfusion.","['5092 patients analyzed, 1396 (27.4%) had diabetes (Restrictive: n\xa0=\xa0679, Liberal n\xa0=\xa0717', 'patients undergoing cardiac surgery on cardiopulmonary bypass with a moderate-to-high risk of death (EuroSCORE ≥6', 'Patients with diabetes', 'Patients with Diabetes Undergoing Cardiac Surgery', 'patients with diabetes undergoing cardiac surgery']","['restrictive transfusion strategy (hemoglobin [Hb] transfusion threshold <75\u2009g/L', 'liberal strategy (Hb <95\u2009g/L for operating room or ICU; or\u2009<\u200985\u2009g/L for ward', 'Restrictive versus Liberal Transfusion']","['cardiovascular disease', 'red blood cell transfusion', 'cause death, stroke, myocardial infarction, and new-onset renal failure requiring dialysis at 6\u2009months', 'components of the composite outcome at 6\u2009months, and transfusion and clinical outcomes at 28\u2009days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5192328', 'cui_str': '27.4'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.234749,"The presence of diabetes did not modify the effect of a restrictive transfusion strategy on the primary composite outcome, but improved its efficacy on red cell transfusion.","[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Mistry', 'Affiliation': ""Department of Anesthesia, St. Michael's Hospital, Institute of Medical Sciences, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Shehata', 'Affiliation': 'Division of Hematology, Departments of Medicine, Laboratory Medicine and Pathobiology, Institute of Health Policy Management and Evaluation, University of Toronto, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Carmona', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Universitari and Politecnic La Fe, Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bolliger', 'Affiliation': 'Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Switzerland.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'François M', 'Initials': 'FM', 'LastName': 'Carrier', 'Affiliation': ""Department of Anesthesiology & Department of Medicine, Critical Care Division, Centre hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Christella S', 'Initials': 'CS', 'LastName': 'Alphonsus', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, South Africa.'}, {'ForeName': 'Elaine E', 'Initials': 'EE', 'LastName': 'Tseng', 'Affiliation': 'Division of Adult Cardiothoracic Surgery, Department of Surgery, University of California San Francisco and San Francisco VA Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Alistair G', 'Initials': 'AG', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, The University of Melbourne and The Royal Melbourne Hospital, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Filipescu', 'Affiliation': 'Department of Cardiac Anaesthesia and Intensive Care Medicine, Emergency Institute for Cardiovascular Diseases, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'Department of Cardiac Anaesthesia, Epic Hospital, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Tarit', 'Initials': 'T', 'LastName': 'Saha', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Villar', 'Affiliation': 'Fundación Cardioinfantil-Instituto de Cardiología, Bogota; Universidad Autónoma de Bucaramanga, Bucaramanga, Columbia.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Gregory', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Duminda N', 'Initials': 'DN', 'LastName': 'Wijeysundera', 'Affiliation': ""Department of Anesthesia, St. Michael's Hospital, Li Ka Shing Knowledge Institute, Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Gregory M T', 'Initials': 'GMT', 'LastName': 'Hare', 'Affiliation': ""Department of Anesthesia, St. Michael's Hospital, Li Ka Shing Knowledge Institute, Department of Physiology, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Ko', 'Affiliation': 'Division of Cardiology, Schulich Heart Centre, Sunnybrook Health Sciences Centre, Institute of Health Policy, Management and Evaluation University of Toronto; ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, Li Ka Shing Knowledge Institute, Department of Surgery, Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""Department of Anesthesia, St. Michael's Hospital, Li Ka Shing Knowledge Institute, Institute of Medical Sciences, Department of Physiology, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.14591']
2498,34747093,Effects of group psychological counseling on transition shock in newly graduated nurses: A quasi-experimental study.,"AIM


This study examined the effects of group psychological counseling on transition shock in newly graduated nurses.
BACKGROUND


Newly graduated nurses are often faced with transition shock as they enter the workforce. Helping them adapt to the new work environment and role as quickly as possible is an important goal for nursing managers.
METHOD


This prospective, parallel-group, quasi-experimental trial enrolled 71 newly graduated nurses, who were randomly assigned to the intervention (n=38) or control (n=41) group. In addition to routine hospital training, the intervention group received psychological counseling. Participants were evaluated with the Transition Shock Scale of Newly Graduated Nurses before (pre) and after (post) the training with or without intervention.
RESULTS


The total score and score on each dimension of the scale were decreased after the intervention (P<0.05); control subjects showed no difference between pre and post scores. The total score and score on each dimension were higher in the control group than in the intervention group (P<0.05).
CONCLUSION


Psychological counseling alleviates transition shock in newly graduated nurses entering the workforce.
IMPLICATIONS FOR NURSING MANAGEMENT


Nursing managers can introduce group psychological counseling into their training programs to increase the job readiness of newly graduated nurses.",2021,The total score and score on each dimension of the scale were decreased after the intervention (P<0.05); control subjects showed no difference between pre and post scores.,"['newly graduated nurses entering the workforce', 'parallel-group, quasi-experimental trial enrolled 71 newly graduated nurses, who were randomly assigned to the intervention (n=38) or control (n=41) group', 'Participants were evaluated with the Transition Shock Scale of Newly Graduated Nurses before (pre) and after (post) the training with or without intervention', 'newly graduated nurses']","['psychological counseling', 'Psychological counseling alleviates transition shock']","['total score and score on each dimension', 'total score and score on each dimension of the scale']","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0474178', 'cui_str': 'Psychological counseling'}, {'cui': 'C0036974', 'cui_str': 'Shock'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",71.0,0.0115617,The total score and score on each dimension of the scale were decreased after the intervention (P<0.05); control subjects showed no difference between pre and post scores.,"[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Nursing Department, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu Province, China.'}, {'ForeName': 'Suyuan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Urology Department, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu Province, China.'}, {'ForeName': 'Wenxia', 'Initials': 'W', 'LastName': 'Bian', 'Affiliation': 'Thyroid and breast surgery Department, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu Province, China.'}, {'ForeName': 'Meifeng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Gastroenterology Department, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu Province, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, Nanjing Medical University/Nanjing Medical University First Affiliated Hospital (Jiangsu Province Hospital), Nanjing, Jiangsu Province, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Interventional radiology department, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu Province, China.'}]",Journal of nursing management,['10.1111/jonm.13506']
2499,34747048,A randomized clinical study using optical coherence tomography to evaluate the short-term effects of high-intensity interval training on cardiac allograft vasculopathy: a HITTS substudy.,"Cardiac allograft vasculopathy (CAV) remains a leading cause of long-term mortality after heart transplantation. Both preventive measures and treatment options are limited. This study aimed to evaluate the short-term effects of high-intensity interval training (HIT) on CAV in de novo heart transplant (HTx) recipients as assessed by optical coherence tomography (OCT). The study population was a subgroup of the 81-patient HITTS study in which HTx recipients were randomized to HIT or moderate intensity continuous training (MICT) for nine consecutive months. OCT images from baseline and 12 months were compared to assess CAV progression. The primary endpoint was defined as the change in the mean intima area. Paired OCT data were available for 56 patients (n = 23 in the HIT group and n = 33 in the MICT group). The intima area in the entire study population increased by 25% [from 1.8±1.4mm 2  to 2.3±2.0mm 2  , p<0.05]. The change was twofold higher in the MICT group (0.6±1.2 mm 2  ) than in the HIT group (0.3±0.6 mm 2  ). However, the treatment effect of HIT was not significant (treatment effect = -0.3 mm 2  , 95% CI [-0.825 to 0.2 mm 2  ] p = 0.29). These results suggest that early initiation of HIT compared with MICT does not attenuate CAV progression in de novo HTx recipients. This article is protected by copyright. All rights reserved.",2021,"However, the treatment effect of HIT was not significant (treatment effect = -0.3 ",['de novo heart transplant (HTx) recipients'],"['high-intensity interval training (HIT', 'high-intensity interval training', 'HIT or moderate intensity continuous training (MICT', 'MICT', 'optical coherence tomography']","['CAV progression', 'cardiac allograft vasculopathy', 'change in the mean intima area']","[{'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C0564471', 'cui_str': 'Allograft heart'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0591935,"However, the treatment effect of HIT was not significant (treatment effect = -0.3 ","[{'ForeName': 'Muzammil', 'Initials': 'M', 'LastName': 'Rafique', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ole Geir', 'Initials': 'OG', 'LastName': 'Solberg', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Bendz', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Niels Ramsing', 'Initials': 'NR', 'LastName': 'Holm', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Omeed', 'Initials': 'O', 'LastName': 'Neghabat', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jouke', 'Initials': 'J', 'LastName': 'Dijkstra', 'Affiliation': 'Division of Image Processing, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Nytrøen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Rolid', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ketil', 'Initials': 'K', 'LastName': 'Lunde', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}]",Clinical transplantation,['10.1111/ctr.14488']
2500,34747042,Randomised controlled trial of an accommodative support lens designed for computer users.,"PURPOSE


Accommodative support (AS) lenses are a low add progressive addition spectacle lens designed to ease symptoms in computer vision syndrome (CVS). The study aims to investigate if (1) AS lenses improve CVS symptoms; (2) binocular/accommodative functions predict a benefit from AS lenses and (3) wearing AS lenses for six months impacts on binocular/accommodative functions.
METHODS


Pre-presbyopic adults with symptoms of CVS (Computer Vision Syndrome Questionnaire, CVS-Q ©  , score ≥ 6) were randomly allocated to wear AS lenses or control single vision (SV) lenses. The CVS-Q ©  and a battery of optometric tests were applied at baseline and after three and six months. Participants and researchers were masked to participant group. After six months, the SV group were unmasked and changed to AS lenses and one week later asked to choose which they preferred.
RESULTS


The change in CVS-Q ©  scores from baseline to six months did not differ significantly in the two groups. At the end of the one week period, when the control group wore the AS lenses, control group participants were significantly more likely to prefer AS lenses to SV lenses. No optometric functions correlated with the benefit from AS lenses. AS lenses did not have any adverse effects on binocular or accommodative function.
CONCLUSIONS


In pre-presbyopic adults, there was no greater improvement in CVS-Q ©  scores in the group wearing AS lenses than in the control group. No adverse effects on optometric function (including accommodation) are associated with wearing AS lenses.",2021,"In pre-presbyopic adults, there was no greater improvement in CVS-Q ©  scores in the group wearing AS lenses than in the control group.",['Pre-presbyopic adults with symptoms of CVS (Computer Vision Syndrome Questionnaire'],"['wear AS lenses or control single vision (SV) lenses', 'Accommodative support (AS) lenses', 'CVS-Q ©', 'accommodative support lens']","['CVS symptoms', 'CVS-Q ©  scores', 'change in CVS-Q ©  scores']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2609092', 'cui_str': 'Computer vision syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C2609092', 'cui_str': 'Computer vision syndrome'}]","[{'cui': 'C2609092', 'cui_str': 'Computer vision syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",6.0,0.112759,"In pre-presbyopic adults, there was no greater improvement in CVS-Q ©  scores in the group wearing AS lenses than in the control group.","[{'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Del Mar Seguí-Crespo', 'Affiliation': 'University of Alicante, Alicante, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ronda-Pérez', 'Affiliation': 'University of Alicante, Alicante, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Yammouni', 'Affiliation': 'Institute of Optometry, London, UK.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Arroyo Sanz', 'Affiliation': 'Hoya Lens Iberia, Coslada, Spain.'}, {'ForeName': 'Bruce J W', 'Initials': 'BJW', 'LastName': 'Evans', 'Affiliation': 'Institute of Optometry, London, UK.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12913']
2501,34747336,Affective and cognitive restoration: Comparing the restorative role of indoor plants and guided meditation.,"This study investigated whether indoor plants were as effective as guided meditation for enabling psychological recovery after fatigue induced by the abbreviated vigilance task. Sixty students were randomly assigned to an indoor plant, guided meditation, or control rest-break condition. The psychological processes most in need of recovery were identified as cognitive and affective restoration. Measures of affect, stress, and working memory were taken before and after the vigilance task, and again after a rest intervention. The vigilance task induced fatigue as shown by a significant vigilance decrement and also significantly lowered positive affect and cognitive engagement, and significantly increased distress across all three conditions. After exposure to the break interventions, distress significantly decreased for participants in the indoor plant break condition while distress significantly decreased and engagement significantly increased in the guided meditation break condition. Indoor plants and guided meditation had a small, but significant positive impact on affective restoration and no significant impact on cognitive restoration. Practitioner summary:  Indoor plants are a cost-effective green ergonomics intervention in offices. This study found that a rest break with indoor plants was as effective as a rest break with guided meditation for affective restoration after fatigue from a vigilance task.",2021,"The vigilance task induced fatigue as shown by a significant vigilance decrement and also significantly lowered positive affect and cognitive engagement, and significantly increased distress across all three conditions.","['offices', 'Sixty students']","['guided meditation', 'indoor plants and guided meditation', 'indoor plant, guided meditation, or control rest-break condition']","['cognitive restoration', 'vigilance task induced fatigue', 'Affective and cognitive restoration', 'affect, stress, and working memory', 'distress']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",60.0,0.0304385,"The vigilance task induced fatigue as shown by a significant vigilance decrement and also significantly lowered positive affect and cognitive engagement, and significantly increased distress across all three conditions.","[{'ForeName': 'Preyen', 'Initials': 'P', 'LastName': 'Archary', 'Affiliation': 'Department of Psychology, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Thatcher', 'Affiliation': 'Department of Psychology, University of the Witwatersrand, Johannesburg, South Africa.'}]",Ergonomics,['10.1080/00140139.2021.2003873']
2502,34747256,Prospective memory deficits following acute alcohol consumption.,"BACKGROUND


Prospective memory is a critical neurocognitive capacity that refers to the ability to execute delayed intentions. To date, few studies have investigated the effects of acute alcohol consumption on prospective memory, and important questions remain about the mechanisms that might underpin acute alcohol-induced prospective memory impairment.
AIMS


The current study sought to clarify the nature and magnitude of prospective memory difficulties following acute alcohol consumption and to test the degree to which any problems with prospective remembering might be a secondary consequence of broader cognitive impairment. This study also investigated whether there were potential sex differences.
METHODS


In all, 124 healthy adult social drinkers were assigned to either the alcohol ( n  = 61) or placebo ( n  = 63) condition. Participants were administered a dose of 0.6 g/kg alcohol or a matched placebo drink and then asked to complete a measure of prospective memory. A broader neurocognitive test battery was also administered.
RESULTS


Relative to the placebo condition, acute alcohol intoxication led to significant impairment on all prospective memory tasks, with effects mostly large in magnitude. These difficulties could not be explained by broader problems in retrospective memory, executive function or episodic future thinking. In addition, females recorded a higher blood alcohol concentration than males; however, no sex differences in prospective memory performance were identified following acute alcohol use.
CONCLUSION


The results show that acutely, even a moderate dose of alcohol substantially impairs prospective memory function. These findings have potentially important implications for understanding many of the maladaptive behaviours associated with acute alcohol consumption.",2021,"Relative to the placebo condition, acute alcohol intoxication led to significant impairment on all prospective memory tasks, with effects mostly large in magnitude.","['acute alcohol consumption', '124 healthy adult social drinkers']","['alcohol', 'placebo', 'kg alcohol or a matched placebo drink']",['blood alcohol concentration'],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}]",124.0,0.00449819,"Relative to the placebo condition, acute alcohol intoxication led to significant impairment on all prospective memory tasks, with effects mostly large in magnitude.","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Elliott', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Terrett', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'De Bono', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Rendell', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Julie D', 'Initials': 'JD', 'LastName': 'Henry', 'Affiliation': 'School of Psychology, The University of Queensland, Brisbane, QLD, Australia.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/02698811211056195']
2503,34747249,Effects of regular exercise on intraocular pressure.,"BACKGROUND


Exercise may potentially provide an adjunctive measure to help control intraocular pressure in glaucoma patients. However, currently, there is still no substantial evidence that regular exercise can produce a prolonged effect of intraocular pressure reduction. We aim to determine the effects of regular exercise on intraocular pressure in healthy individuals.
METHODS


We conducted a prospective, interventional study at the University of Malaya Medical Centre. Our subjects consist of 45 healthy participants in the intervention arm, and 38 healthy control participants who were age- and gender-matched. The intervention arm was enrolled into a supervised exercise programme for a 6-week period, where controls were asked to continue their usual daily lifestyle. The intervention consists of three sessions every week, which focused on aerobic exercise and strength training.
RESULTS


Baseline intraocular pressure was measured, and then remeasured again at the end of 6 weeks of exercise conditioning. In the intervention group, there was a reduction of baseline intraocular pressure from pre-intervention mean intraocular pressure of 15.55 ± 2.63 mmHg, down to 13.36 ± 3.16 mmHg at 6 weeks, a statistically significant reduction of -2.18 ± 2.25 mmHg ( p  < 0.001) post-intervention. On the other hand, the control group recorded a non-statistically significant mean increase of 0.63 ± 2.47 mmHg ( p  = 0.123) at 6 weeks.
CONCLUSIONS


Our study concluded that regular exercise results in a significant intraocular pressure reduction in healthy individuals.",2021,"In the intervention group, there was a reduction of baseline intraocular pressure from pre-intervention mean intraocular pressure of 15.55 ± 2.63 mmHg, down to 13.36 ± 3.16 mmHg at 6 weeks, a statistically significant reduction of -2.18 ± 2.25 mmHg ( p  < 0.001) post-intervention.","['University of Malaya Medical Centre', '45 healthy participants in the intervention arm, and 38 healthy control participants who were age- and gender-matched', 'glaucoma patients', 'healthy individuals']","['supervised exercise programme', 'regular exercise', 'aerobic exercise and strength training']","['reduction of baseline intraocular pressure', 'Baseline intraocular pressure', 'intraocular pressure reduction', 'intraocular pressure']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",45.0,0.022126,"In the intervention group, there was a reduction of baseline intraocular pressure from pre-intervention mean intraocular pressure of 15.55 ± 2.63 mmHg, down to 13.36 ± 3.16 mmHg at 6 weeks, a statistically significant reduction of -2.18 ± 2.25 mmHg ( p  < 0.001) post-intervention.","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Yeak Dieu Siang', 'Affiliation': '37447University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohd Nahar Azmi Bin', 'Initials': 'MNAB', 'LastName': 'Mohamed', 'Affiliation': '37447University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Norlina Binti', 'Initials': 'NB', 'LastName': 'Mohd Ramli', 'Affiliation': '37447University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mimiwati Binti', 'Initials': 'MB', 'LastName': 'Zahari', 'Affiliation': '37447University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}]",European journal of ophthalmology,['10.1177/11206721211051236']
2504,34747219,Preventing postoperative adhesions after hand tendon repair using acellular dermal matrix.,"AIMS


Postoperative tendon adhesions contribute to functional disability and reconstructive failure. In this study, we present the long-term outcomes of a prospective study in which acellular dermal matrix (ADM) was used to prevent postoperative adhesion after tendon injury.
METHODS


The study was conducted between March 2014 and February 2017. Patients, aged 19-65 years, with an acute single flexor tendon injury in zones 1 or 2, distal to the palmar digital crease were candidates for the study. Patients were allocated to either an ADM treatment group or a control group without ADM treatment.
RESULTS


A total of 37 patients were enrolled in the study: 21 patients in the ADM group and 16 patients in the control group. At six months after surgery, the range of motion in the proximal interphalangeal joint was 81.0±5.1 degrees in the ADM group and 75.8±6.9 degrees in the control group. The range of motion in the distal interphalangeal joint was 79.9±7.1 in the ADM group and 71.2±5.7 degrees in the control group, with significant difference (p=0.03 and p<0.05, respectively). In addition, the total active motion was higher in the ADM group than in the control group. The patients' scores on the Patient Satisfaction Questionnaire were also significantly different, with higher satisfaction scores in the ADM group (p=0.02). The minimal follow-up period was six months.
CONCLUSION


The use of ADM after tendon repair has the potential to significantly improve the outcome of tendon surgery in terms of range of motion.
DECLARATION OF INTEREST


None of the authors has any financial interest in the products, devices, or drugs mentioned in this article.",2021,"The range of motion in the distal interphalangeal joint was 79.9±7.1 in the ADM group and 71.2±5.7 degrees in the control group, with significant difference (p=0.03 and p<0.05, respectively).","['Patients, aged 19-65 years, with an acute single flexor tendon injury in zones 1 or 2, distal to the palmar digital crease were candidates for the study', 'March 2014 and February 2017', '37 patients were enrolled in the study: 21 patients in the ADM group and 16 patients in the control group']","['hand tendon repair using acellular dermal matrix', 'ADM treatment group or a control group without ADM treatment', 'acellular dermal matrix (ADM']","['Patient Satisfaction Questionnaire', 'total active motion', 'range of motion in the proximal interphalangeal joint', 'postoperative adhesions', 'satisfaction scores', 'range of motion in the distal interphalangeal joint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0224848', 'cui_str': 'Structure of flexor tendon'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1184147', 'cui_str': 'Palmar'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0187530', 'cui_str': 'Repair of ruptured tendon of hand'}, {'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231481', 'cui_str': 'Active movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C1563055', 'cui_str': 'Interphalangeal joint structure'}, {'cui': 'C0001510', 'cui_str': 'Postoperative adhesion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0932510', 'cui_str': 'Structure of distal interphalangeal joint'}]",37.0,0.0796408,"The range of motion in the distal interphalangeal joint was 79.9±7.1 in the ADM group and 71.2±5.7 degrees in the control group, with significant difference (p=0.03 and p<0.05, respectively).","[{'ForeName': 'Hyung Sup', 'Initials': 'HS', 'LastName': 'Shim', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Kyeong Soo', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Sang Wha', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, College of Medicine, Seoul National University, Seoul National University Hospital, Seoul, Korea.'}]",Journal of wound care,['10.12968/jowc.2021.30.11.890']
2505,34747186,Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial.,"Background:  No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure (LAAC).  Methods:  In the investigator-initiated SWISS APERO trial, patients undergoing LAAC were randomized (1:1) open-label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centres. The primary endpoint was the composite of justified crossover to a non-randomized device during LAAC procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary endpoints included procedural complications, device related thrombus (DRT), peridevice leak (PDL) at transesophageal echocardiography (TEE) and clinical outcomes at 45 days.  Results:  Between June 2018, and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary endpoint was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) Amulet and 70 (70.0%) Watchman patients respectively (risk ratio [RR] 0.97 [95% CI 0.80- 1.16]; P=0.713). A single justified cross-over occurred in an Amulet patient who fulfilled LAA patency criteria at 45-day CCTA. Major procedure related complications occurred more frequently in the Amulet group (9.0% vs. 2.7%; P=0.047), owing to more frequent bleeding (7.2% vs.1.8%). At 45 days, the PDL rate at TEE was higher with Watchman than Amulet (27.5% vs. 13.7%, p=0.020), albeit none was major (i.e. > 5 mm), whereas DRT was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at TEE, respectively. Clinical outcomes at 45 days did not differ between the groups.  Conclusions:  Amulet was not associated with lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, was however associated with lower PDL rates at TEE, higher procedural complications and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation.  Clinical Trial Registration:  URL https://clinicaltrials.gov Unique Identifier NCT03399851.",2021,"Amulet, was however associated with lower PDL rates at TEE, higher procedural complications and similar clinical outcomes at 45 days compared with Watchman.","['Percutaneous Left Atrial Appendage Closure', 'patients undergoing percutaneous LAA closure (LAAC', 'Results:  Between June 2018, and May 2021, 221 patients', 'patients undergoing LAAC']","['open-label to receive Amulet or Watchman 2.5 or FLX (Watchman', 'URL', 'Watchman FLX', 'Amulet or Watchman Device']","['frequent bleeding', 'PDL rates', 'composite of justified crossover to a non-randomized device during LAAC procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA', 'PDL rate at TEE', 'residual LAA patency', 'complications', 'procedural complications, device related thrombus (DRT), peridevice leak (PDL) at transesophageal echocardiography (TEE) and clinical outcomes at 45 days', 'DRT', 'risk ratio [RR']","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0335390', 'cui_str': 'Watchman'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3849574', 'cui_str': 'EPHB2 protein, human'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",221.0,0.260683,"Amulet, was however associated with lower PDL rates at TEE, higher procedural complications and similar clinical outcomes at 45 days compared with Watchman.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Galea', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'De Marco', 'Affiliation': 'Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meneveau', 'Affiliation': 'Besancon University Hospital, EA3920, University of Burgundy Franche-Comté, Besancon, France.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Anselme', 'Affiliation': 'Department of Cardiology, University Hospital of Rouen, Rouen, France.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Gräni', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Adrian T', 'Initials': 'AT', 'LastName': 'Huber', 'Affiliation': 'Department of Diagnostic, Interventional and Pediatric Radiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Teiger', 'Affiliation': 'Department of Cardiology, Henri-Mondor Hospital, Public Assistance Hospitals of Paris, Créteil, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Iriart', 'Affiliation': 'Department of Pediatric and Adult Congenital Cardiology, Hôpital Cardiologique du Haut- Lévêque, CHU de Bordeaux, Bordeaux-Pessac, France.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Babongo Bosombo', 'Affiliation': 'Department of Clinical Research, Clinical Trials Unit and Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Department of Clinical Research, Clinical Trials Unit and Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Franzone', 'Affiliation': 'Department of Advanced Biomedical Sciences, University Federico II University, Naples, Italy.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Fischer', 'Affiliation': 'Department of Neurology, Bern University Hospital, University of Bern, Bern, Switzerland and Department of Neurology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pedrazzini', 'Affiliation': 'Cardiocentro Ticino Institute and Università della Svizzera Italiana (USI), Lugano, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bedogni', 'Affiliation': 'Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland; Cardiocentro Ticino Institute and Università della Svizzera Italiana (USI), Lugano, Switzerland.'}]",Circulation,['10.1161/CIRCULATIONAHA.121.057859']
2506,34750968,The effectiveness of a medical clowning program on improving emotional status among hospitalized children undergoing cancer treatment: A quasi-experimental study.,"PURPOSE


To examine the effectiveness of one-time medical clowning on improving short-term positive emotions among hospitalized children undergoing cancer treatment, and to analyze whether age moderates this effect.
DESIGN


In this quasi-experimental research study, we recruited a pooled sample of 96 children who were undergoing cancer treatment in pediatric oncology/hematology wards at three university-affiliated medical centers in Taiwan from June 2018 through April 2020.
METHODS


Children's demographic characteristics, symptom distress, quality of life, and pretest emotional status were collected at T1. At T2, we collected only posttest emotional status. We adapted generalized estimating equation models to evaluate the effectiveness of medical clowning on enhancing positive emotions.
FINDINGS


Changes in the probabilities of positive emotion were significantly different across groups (51.84% for the experimental group, 15.76% for the control group; Δ = 36.08, p = 0.001), and the change was more than two times larger for the experimental group (effect ratio = 3.28, p < 0.05) than for the control group. When evaluating the moderating effect of age on the intervention, none of the coefficients reached the significant (p < 0.05) levels, suggesting that age may not moderate the intervention effect.
CONCLUSION


This study demonstrates the core value of medical clowning in child-friendly health care. Our findings clearly support the benefit of the one-time medical clowning program on enhancing short-term emotional well-being across age groups of children. Medical clowning programs should be strongly encouraged and supported in pediatric oncology wards.
CLINICAL RELEVANCE


Medical clowning programs should be widely and continuously implemented in pediatric oncology wards as a routine clinical practice for enhancing emotional well-being among children receiving cancer treatment. Nurses need to be aware of medical clowning's equal effectiveness across age groups, not only or better for younger children.",2021,"FINDINGS


Changes in the probabilities of positive emotion were significantly different across groups (51.84% for the experimental group, 15.76% for the control group; Δ = 36.08, p = 0.001), and the change was more than two times larger for the experimental group (effect ratio = 3.28, p < 0.05) than for the control group.","['children receiving cancer treatment', 'child-friendly health care', 'hospitalized children undergoing cancer treatment', '96 children who were undergoing cancer treatment in pediatric oncology/hematology wards at three university-affiliated medical centers in Taiwan from June 2018 through April 2020', ""Children's""]",['medical clowning program'],"['probabilities of positive emotion', 'demographic characteristics, symptom distress, quality of life, and pretest emotional status', 'emotional status']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C1518927', 'cui_str': 'Pediatric hematology oncology'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",96.0,0.0861586,"FINDINGS


Changes in the probabilities of positive emotion were significantly different across groups (51.84% for the experimental group, 15.76% for the control group; Δ = 36.08, p = 0.001), and the change was more than two times larger for the experimental group (effect ratio = 3.28, p < 0.05) than for the control group.","[{'ForeName': 'Wei-Wen', 'Initials': 'WW', 'LastName': 'Wu', 'Affiliation': 'School of Nursing, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Lu', 'Affiliation': ""Department of Pediatrics, National Taiwan University Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Cheng-Shi', 'Initials': 'CS', 'LastName': 'Shiu', 'Affiliation': 'Department of Social Work, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chia-Chun', 'Initials': 'CC', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Shiann-Tang', 'Initials': 'ST', 'LastName': 'Jou', 'Affiliation': ""Department of Pediatrics, National Taiwan University Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Jiann-Shiuh', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Yen-Lin', 'Initials': 'YL', 'LastName': 'Liu', 'Affiliation': 'Department of Pediatrics, Taipei Medical University Hospital, Taipei, Taiwan.'}]",Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing,['10.1111/jnu.12720']
2507,34750933,"Triple combination therapy of narrowband ultraviolet B, fractional carbon dioxide laser and topical bimatoprost 0.01% for non-segmental vitiligo on non-facial areas: A randomized half-body, double-blind, placebo-controlled, comparative study.","Combination therapy shows superior outcomes over monotherapy in treating vitiligo. Topical bimatoprost is a melanogenic agent effectively used to induce repigmentation. However, topical bimatoprost 0.01% has never been explored in non-facial vitiligo, and triple therapy of phototherapy, fractional laser and topical bimatoprost has never been examined. This study aims to investigate the efficacy and safety of triple-modality treatment, combining narrowband ultraviolet B (NB-UVB), fractional carbon dioxide (CO 2  ) laser and topical bimatoprost 0.01% for stable non-segmental vitiligo on non-facial areas. Fifteen vitiligo patients with at least two symmetrical, comparable-sized lesions on non-facial regions were included. The paired lesions were randomized to receive a treatment regimen of twice-daily application of either bimatoprost 0.01% solution or placebo in combination with once-monthly fractional CO 2  laser and twice-weekly NB-UVB therapy for 12 weeks. There were no statistically significant differences in the vitiligo surface area (VSA) and melanin concentration (MC) at baseline between treatment sides. After 12 weeks of treatment, the percentage change from baseline of MC on the triple-therapy side was significantly higher than that on the dual-therapy side, 27.17 ± 13.62 % versus 22.82 ± 10.10 % (p =.028). The change from baseline of VSA was also greater on the triple-therapy side; however, a statistically significant difference was not reached. Improvement grades of repigmentation and adverse events were similar on both sides. Triple therapy with NB-UVB, fractional CO 2  laser and topical bimatoprost 0.01% tends to be safe and more effective as compared to dual therapy of NB-UVB and fractional CO 2  laser in non-facial vitiligo. This article is protected by copyright. All rights reserved.",2021,There were no statistically significant differences in the vitiligo surface area (VSA) and melanin concentration (MC) at baseline between treatment sides.,"['non-segmental vitiligo on non-facial areas', 'stable non-segmental vitiligo on non-facial areas', 'Fifteen vitiligo patients with at least two symmetrical, comparable-sized lesions on non-facial regions']","['bimatoprost 0.01% solution or placebo in combination with once-monthly fractional CO 2  laser and twice-weekly NB-UVB therapy', 'placebo', 'narrowband ultraviolet B (NB-UVB), fractional carbon dioxide (CO 2  ) laser and topical bimatoprost', 'narrowband ultraviolet B, fractional carbon dioxide laser and topical bimatoprost']","['vitiligo surface area (VSA) and melanin concentration (MC', 'VSA', 'Improvement grades of repigmentation and adverse events', 'efficacy and safety']","[{'cui': 'C1274648', 'cui_str': 'Segmental vitiligo'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0934422', 'cui_str': 'Region of face'}]","[{'cui': 'C0937917', 'cui_str': 'bimatoprost'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585302', 'cui_str': 'Once monthly'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",15.0,0.0581493,There were no statistically significant differences in the vitiligo surface area (VSA) and melanin concentration (MC) at baseline between treatment sides.,"[{'ForeName': 'Silada', 'Initials': 'S', 'LastName': 'Kanokrungsee', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Khunkhet', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Salinee', 'Initials': 'S', 'LastName': 'Rojhirunsakool', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Kamonwan', 'Initials': 'K', 'LastName': 'Thadvibun', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Thanyapat', 'Initials': 'T', 'LastName': 'Sahaspot', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}]",Dermatologic therapy,['10.1111/dth.15198']
2508,34751384,"Advances in the use of electrospun nanofibrous polymeric matrix for dermal healing at the donor site after the split-thickness skin graft excision: a prospective, randomized, controlled, open-label, multicenter study.","Dressings used to manage donor site wounds have up to 40% of patients experiencing complications that may cause suboptimal scarring. We evaluated the efficacy and safety of a portable electrospun nanofibrous matrix that provides contactless management of donor site wounds compared with standard dressing techniques. This study included adult patients who underwent an excised split-thickness skin graft with a donor site wound area of 10-200 cm 2. Patients were allocated into two groups; i.e., the nanofiber group managed with a nanofibrous polymer-based matrix, and the control group managed using the standard of care such as Jelonet® or Biatain® Ibu dressing. Primary outcomes were postoperative dermal healing efficacy assessed by Draize scores. The time to complete re-epithelialization was also recorded. Secondary outcomes included postoperative adverse events, pain, and infections during the first 21-days and extended 12-month follow-up. The itching and scarring were recorded during the extended follow-up (months 1,3,6,9,12) using Numerical-Analogue-Score and Vancouver scores, respectively. The nanofiber and control groups included 21 and 20 patients, respectively. The Draize dermal irritation scores were significantly lower in the nanofiber vs. control group (Z=-2.509; P=0.028) on the first postoperative day but became similar afterward (Z≥-1.62; P≥0.198). In addition, the average time to re-epithelialization was similar in the nanofiber (17.9±4.4 days) and control group (18.3±4.5 days) (Z=-0.299; P=0.764), so were postoperative adverse events, pain, and infection incidence, itching and scarring. The safety and efficacy of electrospun nanofibrous matrix are similar to standard wound care allowing its use as an alternative donor site dressing following the split-thickness skin graft excision.",2021,The Draize dermal irritation scores were significantly lower in the nanofiber vs. control group (Z=-2.509; P=0.028) on the first postoperative day but became similar afterward (Z≥-1.62; P≥0.198).,['adult patients who underwent an excised split-thickness skin graft with a donor site wound area of 10-200\xa0cm 2'],"['electrospun nanofibrous polymeric matrix', 'nanofiber group managed with a nanofibrous polymer-based matrix, and the control group managed using the standard of care such as Jelonet® or Biatain® Ibu dressing', 'electrospun nanofibrous matrix', 'portable electrospun nanofibrous matrix']","['Draize dermal irritation scores', 'postoperative dermal healing efficacy assessed by Draize scores', 'postoperative adverse events, pain, and infections during the first 21-days and extended 12-month follow-up', 'time to complete re-epithelialization', 'efficacy and safety', 'postoperative adverse events, pain, and infection incidence, itching and scarring', 'itching and scarring', 'average time to re-epithelialization']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C1881960', 'cui_str': 'Nanofibers'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0534488', 'cui_str': 'jelonet'}, {'cui': 'C0721022', 'cui_str': 'Ibu'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0334221', 'cui_str': 'Re-epithelialization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]",,0.0135731,The Draize dermal irritation scores were significantly lower in the nanofiber vs. control group (Z=-2.509; P=0.028) on the first postoperative day but became similar afterward (Z≥-1.62; P≥0.198).,"[{'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Haik', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Sheba Medical Center, Ramat-Gan, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Ullman', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Rambam Health Care Campus, affiliated with the Rappaport Faculty of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Gur', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Sourasky Medical Center, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Ad-El', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Rabin Medical Center, Petah-Tikva, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Egozi', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Kaplan Medical Center, Rehovot, Israel.'}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Kruchevsky', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Rambam Health Care Campus, affiliated with the Rappaport Faculty of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Zissman', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Sourasky Medical Center, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Biros', 'Affiliation': 'College of Medicine and Dentistry, James Cook University, Townsville, Australia.'}, {'ForeName': 'Rony-Reuven', 'Initials': 'RR', 'LastName': 'Nir', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Sheba Medical Center, Ramat-Gan, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kornhaber', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Sheba Medical Center, Ramat-Gan, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cleary', 'Affiliation': 'School of Nursing, Midwifery and Social Sciences, CQUniversity Australia.'}, {'ForeName': 'Moti', 'Initials': 'M', 'LastName': 'Harats', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Sheba Medical Center, Ramat-Gan, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/irab216']
2509,34751177,Does the use of ultrasound guidance during percutaneous Achilles tendon tenotomy improve outcomes of clubfoot management? A randomized controlled trial.,"OBJECTIVE


Achilles tenotomy is a crucial aspect in the non-operative management of clubfoot as per Ponseti's casting protocol. Achilles tenotomy is routinely carried out percutaneously in a blind manner without any image guidance. This study aimed to determine the role of ultrasound-guided percutaneous Achilles tenotomy (PAT) in improving outcomes in clubfoot management. There are no previous studies that have explored the role of image guidance in PAT.
METHODS


This prospective, single-center randomized control trial included 50 clubfoot cases (74 feet) planned for PAT at a mean age of 30.2 months. A single experienced senior surgeon performed tenotomies. Patients were randomized to two groups, with the tenotomies performed under ultrasound guidance in one group (test group) and PAT carried out without image guidance in the other (control) group. Outcome measures assessed included rate of complications, immediate postoperative FLACC score for pain severity and Pirani score at a minimum follow-up of 12 months.
RESULTS


There were no significant differences in the complication rates between the test and control groups regarding bleeding, nerve injury and incomplete tenotomies. The mean pain FLACC score was significantly higher in the control group (PAT without image guidance) (P = 0.03), suggesting that the child would better tolerate the ultrasound-guided procedure. All patients in both groups had a Pirani score of zero and plantigrade feet at final follow up, with no relapses.
CONCLUSION


Ultrasound-guided PAT does not have any added advantage over PAT with clinical examination without image guidance in terms of long-term outcomes.
LEVEL OF EVIDENCE


Therapeutic level II.",2021,"There were no significant differences in the complication rates between the test and control groups regarding bleeding, nerve injury and incomplete tenotomies.",['50 clubfoot cases (74 feet) planned for PAT at a mean age of 30.2 months'],"['ultrasound guidance', 'tenotomies performed under ultrasound guidance in one group (test group) and PAT carried out without image guidance in the other (control) group', 'ultrasound-guided percutaneous Achilles tenotomy (PAT']","['bleeding, nerve injury and incomplete tenotomies', 'mean pain FLACC score', 'rate of complications, immediate postoperative FLACC score for pain severity and Pirani score', 'complication rates', 'Pirani score of zero and plantigrade feet']","[{'cui': 'C0009081', 'cui_str': 'Talipes equinovarus'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0407093', 'cui_str': 'Adductor tenotomy of hip'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C2936600', 'cui_str': 'Tenotomy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0407093', 'cui_str': 'Adductor tenotomy of hip'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0442972', 'cui_str': 'Imaging guidance'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C2936600', 'cui_str': 'Tenotomy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]",50.0,0.0555428,"There were no significant differences in the complication rates between the test and control groups regarding bleeding, nerve injury and incomplete tenotomies.","[{'ForeName': 'Pardeep', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopaedics, Civil Hospital, Jind, Haryana Department of Orthopaedics, AIIMS Bilaspur, Himachal Pradesh, India Department of Orthopaedics, Nisarga Hospital, Dhangadhi, Nepal Department of Orthopaedics, JSS Medical College, Mysore Department of Orthopaedics, PGIMER Chandigarh, India.'}, {'ForeName': 'Vishnu', 'Initials': 'V', 'LastName': 'Baburaj', 'Affiliation': ''}, {'ForeName': 'Omkar', 'Initials': 'O', 'LastName': 'Bist', 'Affiliation': ''}, {'ForeName': 'Prashasth S', 'Initials': 'PS', 'LastName': 'Belludi', 'Affiliation': ''}, {'ForeName': 'Pebam', 'Initials': 'P', 'LastName': 'Sudesh', 'Affiliation': ''}]",Journal of pediatric orthopedics. Part B,['10.1097/BPB.0000000000000934']
2510,34751506,Effects of Vitality Acupunch exercise on functional fitness and activities of daily living among probable sarcopenic older adults in residential facilities.,"PURPOSE


To test the effects of a Vitality Acupunch exercise program on the functional fitness and the ability to perform the activities of daily living (ADL) among older adults with probable sarcopenia in residential facilities.
DESIGN


This was a cluster-randomized controlled trial. A total of 12 long-term care facilities randomly assigned to the intervention and control groups with 1:1 allocation ratio. Among them, 114 older adults with probable sarcopenia participated at baseline and were allocated to either the intervention or control group according to the facility where they resided in. Of these, 103 older adults completed the study.
METHODS


The intervention group (n = 52) underwent the Vitality Acupunch exercise program three times a week, each lasting 40 min, for 6 months while the control group (n = 51) performed its routine daily activities.
FINDINGS


The functional fitness and ADL of the intervention group significantly improved at each time point (all p < 0.001), while the control group showed a significant decreasing trend. Except the lower limb muscular endurance, the functional fitness and ADL of the intervention group significantly improved compared to the control group at T1, and the improvements were still significant at T2.
CONCLUSIONS


Functional fitness and the ability to perform ADL in older adults with probable sarcopenia were significantly improved after receiving the Vitality Acupunch exercises.
CLINICAL RELEVANCE


An exercise that integrates the meridian theory and exercise concepts effectively improves functional fitness in probable sarcopenic older adults.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov (NCT04504786). The trial was first posted on August 7, 2020. This part of the data was collected from August 2020 to March 2021.",2021,"Except the lower limb muscular endurance, the functional fitness and ADL of the intervention group significantly improved compared to the control group at T1, and the improvements were still significant at T2.
","['probable sarcopenic older adults', '103 older adults completed the study', '114 older adults with probable sarcopenia participated at baseline', 'older adults with probable sarcopenia in residential facilities', 'probable sarcopenic older adults in residential facilities']","['Vitality Acupunch exercise', 'Vitality Acupunch exercise program']","['functional fitness', 'functional fitness and activities of daily living', 'lower limb muscular endurance, the functional fitness and ADL', 'activities of daily living (ADL']","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",,0.0643716,"Except the lower limb muscular endurance, the functional fitness and ADL of the intervention group significantly improved compared to the control group at T1, and the improvements were still significant at T2.
","[{'ForeName': 'Hsiao-Ting', 'Initials': 'HT', 'LastName': 'Tung', 'Affiliation': 'Department of Nursing, Kaohsiung Armed Forces General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Kuei-Min', 'Initials': 'KM', 'LastName': 'Chen', 'Affiliation': 'College of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Kuo-Chin', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Fen', 'Initials': 'HF', 'LastName': 'Hsu', 'Affiliation': 'Center of Long-Term Care Research, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Chia-Pei', 'Initials': 'CP', 'LastName': 'Chou', 'Affiliation': 'Department of Family Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chuan-Feng', 'Initials': 'CF', 'LastName': 'Kuo', 'Affiliation': 'Center of Long-Term Care Research, Kaohsiung Medical University, Kaohsiung, Taiwan.'}]",Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing,['10.1111/jnu.12723']
2511,34751479,Comparison of apical debris extrusion during root canal preparation in primary molars using different file systems: an in vitro study.,"This study aimed to compare the amount of debris extrusion of four endodontic systems made of Nickle-Titanium alloy. This in vitro study was done on 80 extracted primary molars. They were selected by cone-beam computed tomography and randomly divided into four groups (n = 20) to be prepared to the apical size of 25 by one of the systems: Reciproc, Protaper Universal, Neolix, or Hyflex CM. Debris was collected into Eppendorf microtubes and placed in an incubator to evaporate the washing solution. Debris was weighed by a digital scale of 0.01 g precision. Data were statistically analysed using SPSS software. Tukey's comparison was used to determine the difference between the four file systems (α = 0.05). Debris extrusion after Reciproc preparation (0.00320) was significantly higher than the other (P < 0.05), with no significant difference having been observed among the other systems (P > 0.05). It can be concluded that all systems under investigation exhibited debris extrusion.",2021,"Debris extrusion after Reciproc preparation (0.00320) was significantly higher than the other (P < 0.05), with no significant difference having been observed among the other systems (P > 0.05).",['80 extracted primary molars'],"['Reciproc, Protaper Universal, Neolix, or Hyflex CM', 'apical debris extrusion during root canal preparation', 'Nickle-Titanium alloy']",['Debris extrusion'],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0282543', 'cui_str': 'Root canal preparation'}, {'cui': 'C0076732', 'cui_str': 'titanium alloy (TiAl6V4)'}]","[{'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}]",80.0,0.0230004,"Debris extrusion after Reciproc preparation (0.00320) was significantly higher than the other (P < 0.05), with no significant difference having been observed among the other systems (P > 0.05).","[{'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Ilam Medical University, Ilam, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mehran', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Shahed University, Tehran, Iran.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Frankenberger', 'Affiliation': 'Department of Operative Dentistry and Endodontics, Dental School, University of Marburg and University Medical Center Giessen and Marburg, Marburg, Germany.'}, {'ForeName': 'Newsha', 'Initials': 'N', 'LastName': 'BabeveyNejad', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Shahed University, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Banakar', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Shahed University, Tehran, Iran.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Haghgoo', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Shahed University, Tehran, Iran.'}]",Australian endodontic journal : the journal of the Australian Society of Endodontology Inc,['10.1111/aej.12582']
2512,34751456,Does the interference phenomenon affect strength development during same-session combined rehabilitation program in hemodialysis patients?,"INTRODUCTION


This study aimed to assess if an interference effect could blunt the neuromuscular gains induced by a same-session combined rehabilitation in hemodialysis (HD) patients.
METHODS


Patients exercised twice a week, for 16 weeks, over their HD sessions. They were either always trained with resistance and endurance exercises (continuous training, ""CONT"") or alternatively with 1 week of resistance alternated with 1 week of endurance (discontinuous training, ""DISC""). Adherence and workload were continuously recorded. Short Physical Performance Battery (SPPB) score, one-leg balance test, and handgrip and quadriceps strength were evaluated before and after training intervention.
RESULTS


Adherence to both programs was high (>90%). SPPB score had significantly improved (CONT: +1.5 point, DISC: +1.2 pt, p < 0.001), like one-leg balance test (CONT: +3.7 s, DISC: +5.5 s, p < 0.05), handgrip strength of exercised (CONT: +5.5 kg, DISC: +5.6 kg, p < 0.001) and of nonexercised arm (CONT: +4.4 kg, DISC: +2.8 kg, p < 0.01) as well as maximal quadriceps strength (+22 N·m for dominant and +29 N·m for nondominant leg in both groups, p < 0.001) bearing no difference between the trainings.
CONCLUSION


Same-session combined training does not induce an interference effect in HD patients and temporal separation of exercises does not optimize strength gains. These practical data may be relevant for clinicians and practitioners to alternate endurance and resistance exercises.",2021,"SPPB score had significantly improved (CONT: +1.5 point, DISC: +1.2 pt, p < 0.001), like one-leg balance test (CONT: +3.7 s, DISC: +5.5 s, p < 0.05), handgrip strength of exercised (CONT: +5.5 kg, DISC: +5.6 kg, p < 0.001) and of nonexercised arm (CONT: +4.4 kg, DISC: +2.8 kg, p < 0.01) as well as maximal quadriceps strength (+22 N·m for dominant and +29 N·m for nondominant leg in both groups, p < 0.001) bearing no difference between the trainings.
","['hemodialysis patients', 'hemodialysis (HD) patients']","['resistance and endurance exercises (continuous training, ""CONT"") or alternatively with 1\u2009week of resistance alternated with 1\u2009week of endurance (discontinuous training, ""DISC']","['SPPB score', 'like one-leg balance test', 'Adherence and workload', 'maximal quadriceps strength', 'handgrip strength of exercised', 'Short Physical Performance Battery (SPPB) score, one-leg balance test, and handgrip and quadriceps strength']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439599', 'cui_str': 'Discontinuous'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.00923153,"SPPB score had significantly improved (CONT: +1.5 point, DISC: +1.2 pt, p < 0.001), like one-leg balance test (CONT: +3.7 s, DISC: +5.5 s, p < 0.05), handgrip strength of exercised (CONT: +5.5 kg, DISC: +5.6 kg, p < 0.001) and of nonexercised arm (CONT: +4.4 kg, DISC: +2.8 kg, p < 0.01) as well as maximal quadriceps strength (+22 N·m for dominant and +29 N·m for nondominant leg in both groups, p < 0.001) bearing no difference between the trainings.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pavlin', 'Affiliation': 'DMEM, UMR866, INRAE, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Fondation Charles Mion - AIDER Santé, AIDER Santé, Montpellier, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ohresser', 'Affiliation': 'Fondation Charles Mion - AIDER Santé, AIDER Santé, Montpellier, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Larivière', 'Affiliation': 'Fondation Charles Mion - AIDER Santé, AIDER Santé, Montpellier, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Portal', 'Affiliation': 'Fondation Charles Mion - AIDER Santé, AIDER Santé, Montpellier, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Cristol', 'Affiliation': 'Department of Biochemistry, University Hospital of Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Bernardi', 'Affiliation': 'DMEM, UMR866, INRAE, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Turc-Baron', 'Affiliation': 'Fondation Charles Mion - AIDER Santé, AIDER Santé, Montpellier, France.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Candau', 'Affiliation': 'DMEM, UMR866, INRAE, University of Montpellier, Montpellier, France.'}]",Seminars in dialysis,['10.1111/sdi.13033']
2513,34751427,Facet Median Branch Radiofrequency Thermocoagulation Treatment at Different Temperatures and Durations in Patients with Lumbar Facet Syndrome: A Randomized Controlled Double-Blind Study.,"AIM


Radiofrequency thermocoagulation (RFT) at various temperatures and durations will be evaluated in this study to treat low back pain caused by facet joints.
MATERIAL AND METHODS


This is a randomized controlled, double-blind study. Patients diagnosed with facet syndrome were randomly divided into three groups. RFT was applied to the medial branches, which received senses from the facet joint 90ºC 50 seconds in 31 patients, 85ºC 60 seconds in 32 patients, 70ºC 90 seconds in 33 patients at constant current and impedance values. Numeric Rating Scale (NRS) scores before and after the treatment (1 and 6 months), the need for additional analgesics after treatment, and opioid dose changes were recorded.
RESULTS


The demographic data of the groups were similar. NRS scores in all three groups were significantly lower at 1 and 6 months (p 0.001, p 0.001, p 0.001, respectively). At the first and sixth months, there was no significant difference between the groups in patients who experienced a 50% reduction in pain intensity (p=0.1, p=0.7, respectively). Patients who had back surgery had a significantly lower rate of pain regression (p=0.001).
CONCLUSION


In patients with lumbar facet syndrome, RFT application in every 3 degrees and seconds is effective because it generates equal energy, and there was no significant difference in pain relief between the groups.",2021,"At the first and sixth months, there was no significant difference between the groups in patients who experienced a 50% reduction in pain intensity (p=0.1, p=0.7, respectively).","['Patients with Lumbar Facet Syndrome', 'Patients diagnosed with facet syndrome']","['Facet Median Branch Radiofrequency Thermocoagulation Treatment', 'Radiofrequency thermocoagulation (RFT', 'RFT']","['pain relief', 'NRS scores', 'rate of pain regression', 'pain intensity', 'Numeric Rating Scale (NRS) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458225', 'cui_str': 'Lumbar facet joint pain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0423690', 'cui_str': 'Facet joint pain'}]","[{'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.14899,"At the first and sixth months, there was no significant difference between the groups in patients who experienced a 50% reduction in pain intensity (p=0.1, p=0.7, respectively).","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ertilav', 'Affiliation': 'Adnan Menderes University, School of Medicine, Department of Neurology, Division of Algology, Aydin, Turkey.'}, {'ForeName': 'Osman Nuri', 'Initials': 'ON', 'LastName': 'Aydin', 'Affiliation': ''}, {'ForeName': 'Kamil Varlik', 'Initials': 'KV', 'LastName': 'Erel', 'Affiliation': ''}]",Turkish neurosurgery,['10.5137/1019-5149.JTN.34637-21.2']
2514,34751888,Promoting Strong Latino Families Within an Emerging Immigration Context: Results of a Replication and Extension Trial of a Culturally Adapted Preventive Intervention.,"We conducted a randomized controlled trial (RCT) of Nuestras Familias: Andando Entre Culturas, a culturally adapted evidence-based parent management training (PMT) preventive intervention, with a sample of 241 Spanish-speaking Latino parents and their middle-school-aged children residing in an emerging immigration context. Scientifically rigorous studies of programs designed for this setting are rare. The intervention was designed to promote prosocial parenting practices and to prevent youth substance use and related problem behaviors. The RCT was designed as an extension and replication of a prior trial (Martinez & Eddy in Journal of Consulting and Clinical Psychology, 73, 841-851, 2005) which was also conducted in an emerging immigration context. Two key issues were of primary interest: intervention feasibility and intervention efficacy. Intervention feasibility was assessed through weekly session attendance, participation, and parent-reported session satisfaction as well as overall program satisfaction. Intervention efficacy was assessed by comparing changes within the intervention and control groups on parenting practices and youth adjustment from pre-intervention baseline to post-intervention termination 6 months later. Results provided support for the feasibility of delivering the intervention on a large scale within communities. Consistent with the prior trial, positive effects of the intervention were detected on parenting practices and on youth outcomes. Differential effects of the intervention were detected based on youth gender and nativity status, such that girls benefited the most with respect to tobacco use likelihood, and foreign-born youth benefited the most with respect to decreased depressive symptoms.Findings provide additional evidence for Nuestras Familias as an efficacious family-based intervention for Latino families within communities that are sites of emerging immigration in terms of both improving parenting practices and decreasing risk for youth substance use and related problem behaviors.",2021,Findings provide additional evidence for Nuestras Familias as an efficacious family-based intervention for Latino families within communities that are sites of emerging immigration in terms of both improving parenting practices and decreasing risk for youth substance use and related problem behaviors.,['241 Spanish-speaking Latino parents and their middle-school-aged children residing in an emerging immigration context'],"['Nuestras Familias: Andando Entre Culturas, a culturally adapted evidence-based parent management training (PMT) preventive intervention']",['Intervention efficacy'],"[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020942', 'cui_str': 'In-Migration'}, {'cui': 'C0449255', 'cui_str': 'Context'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0344488,Findings provide additional evidence for Nuestras Familias as an efficacious family-based intervention for Latino families within communities that are sites of emerging immigration in terms of both improving parenting practices and decreasing risk for youth substance use and related problem behaviors.,"[{'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Martinez', 'Affiliation': 'Texas Center for Equity Promotion, College of Education, The University of Texas at Austin, Austin, TX, USA. charlesm@austin.utexas.edu.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'Eddy', 'Affiliation': 'Texas Center for Equity Promotion, College of Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Heather H', 'Initials': 'HH', 'LastName': 'McClure', 'Affiliation': 'Center for Equity Promotion, College of Education, University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Cory L', 'Initials': 'CL', 'LastName': 'Cobb', 'Affiliation': 'Texas Center for Equity Promotion, College of Education, The University of Texas at Austin, Austin, TX, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-021-01323-7']
2515,34751818,Teaching medical students to choose wisely through simulation.,"The Choosing Wisely (CW) campaign aims to encourage dialog among physicians and patients about the costs and benefits of medical care. The purpose of the present study was to describe the implementation of the CW campaign among medical students in the pediatrics clerkship using different teaching strategies and to evaluate the students' perception and performance. A prospective, interventionist, open study with a control group was conducted. All sixth-year undergraduate medical students that were on their pediatric clerkship at the Emergency Department during the study period were invited to participate. The study consisted of two strategies: a remote video class about the CW initiative and in situ simulation training. By the end of the rotation, all participants were evaluated through an Objective Structured Clinical Examination (OSCE). A total of 50 students were included, of which 24 watched only the online video (control group) and 26 were exposed to both the online video and the simulation scenarios (intervention group). Students in the intervention group had a significantly higher total score in the OSCE compared to students in the control group (median 90 vs 90; range 78-100 vs 50-100; p: 0.047). Median scores of behavioral items of the OSCE grouped together were significantly higher in the intervention group compared to the control group (median 60 vs 50; range 40-60 vs 20-60; p: 0.002).Conclusion: Simulation training about principles of the CW campaign had a greater impact on behavioral aspects of undergraduate students. This learning strategy was well accepted by participants. What is Known: • The Choosing Wisely (CW) campaign aims to encourage dialog among physicians and patients about the costs and benefits of medical care. • Teaching high-value and cost-conscious care to medical students is highly desired.. What is New: • Simulation training about principles of the CW campaign had a greater impact on behavioral aspects of undergraduate students.",2021,Median scores of behavioral items of the OSCE grouped together were significantly higher in the intervention group compared to the control group (median 60 vs 50; range 40-60 vs 20-60; p: 0.002).Conclusion: Simulation training about principles of the CW campaign had a greater impact on behavioral aspects of undergraduate students.,"['undergraduate students', 'medical students', 'All sixth-year undergraduate medical students that were on their pediatric clerkship at the Emergency Department during the study period were invited to participate', 'A total of 50 students were included, of which 24 watched only the online video (control group) and 26 were exposed to both the online video and the simulation scenarios (intervention group']","['CW campaign', 'remote video class about the CW initiative and in situ simulation training']","['Objective Structured Clinical Examination (OSCE', 'Median scores of behavioral items', 'OSCE', 'total score']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",50.0,0.0121705,Median scores of behavioral items of the OSCE grouped together were significantly higher in the intervention group compared to the control group (median 60 vs 50; range 40-60 vs 20-60; p: 0.002).Conclusion: Simulation training about principles of the CW campaign had a greater impact on behavioral aspects of undergraduate students.,"[{'ForeName': 'Thayza Marcelly Rodrigues', 'Initials': 'TMR', 'LastName': 'Morato', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Pedro Henrique Magalhães', 'Initials': 'PHM', 'LastName': 'Mendes', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Danielle Saad Nemer Bou', 'Initials': 'DSNB', 'LastName': 'Ghosn', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Thomaz Bittencourt', 'Initials': 'TB', 'LastName': 'Couto', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Paulo Victor Ferreira', 'Initials': 'PVF', 'LastName': 'Mai', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Sylvia Costa Lima', 'Initials': 'SCL', 'LastName': 'Farhat', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'Schvartsman', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Nara Vasconcelos', 'Initials': 'NV', 'LastName': 'Cavalcanti', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil. cavalcantinara@gmail.com.'}]",European journal of pediatrics,['10.1007/s00431-021-04305-7']
2516,34751787,Acute CTX-1 Suppression With Milk Calcium or Calcium Carbonate is Independent of Visceral Fat in A Randomized Crossover Study in Lean and Overweight Postmenopausal Women.,"BACKGROUND


Postmenopausal women with higher visceral adipose tissue (VAT) present with suppressed bone resorption (lower c-terminal cross-linking telopeptide of type I collagen, CTX-1) and turnover (lower osteocalcin) but whether this blunts the effect of calcium is unknown.
OBJECTIVE


The primary outcome of this study was the effect of VAT on changes in CTX-1 after intake of two forms of calcium. Secondary outcomes included changes in parathyroid hormone (PTH), serum calcium, phosphorus, and alkaline phosphatase (ALP).
DESIGN


Randomized open three period crossover trial conducted between 2017-2019 at the University of South Australia among 77 lean and overweight postmenopausal women (53-79 y) with body mass index (BMI) less than 25 kg/m2 and greater than 27 kg/m2, respectively. Participants received a single dose of milk (1000 mg calcium), calcium carbonate tablet (1000 mg calcium), and fruit juice (no calcium) in random order with a seven-day washout period. Blood samples were collected at baseline and hourly for 5h. Data was analysed by repeated measures analysis of variance (ANOVA) of log-transformed data.
RESULTS


At baseline, women with higher VAT had significantly lower CTX-1 and higher PTH (44% lower and 30% higher, respectively between Q4 and Q1, P < 0.0001). VAT had no influence on the acute changes in CTX-1 or PTH with calcium or juice. A suppression of 44% in CTX-1 was seen with calcium carbonate and milk and a suppression of 18% with juice. PTH was suppressed more with calcium carbonate (47%) compared to milk (22%). Milk calcium reduced PTH and CTX-1 at 2-hour while calcium carbonate reduced PTH in 1 hour. The suppression in CTX-1 was slower with lowest levels at 4-5 hour.
CONCLUSIONS


1000 mg calcium obtained from milk or from calcium carbonate is effective in acutely suppressing bone resorption in postmenopausal women irrespective of visceral fat.This trial is registered with the Australian New Zealand Clinical Trials Registry http://www.ANZCTR.org.au/ACTRN12617000779370.aspx (ACTRN 12617000779370).",2021,"At baseline, women with higher VAT had significantly lower CTX-1 and higher PTH (44% lower and 30% higher, respectively between Q4 and Q1, P < 0.0001).","['Lean and Overweight Postmenopausal Women', 'Postmenopausal women with higher visceral adipose tissue (VAT', 'postmenopausal women irrespective of visceral fat', '2017-2019 at the University of South Australia among 77 lean and overweight postmenopausal women (53-79 y) with body mass index (BMI']","['VAT', 'calcium carbonate', 'Milk Calcium or Calcium Carbonate', 'single dose of milk (1000\xa0mg calcium), calcium carbonate tablet (1000\xa0mg calcium), and fruit juice (no calcium']","['Blood samples', 'PTH', 'changes in parathyroid hormone (PTH), serum calcium, phosphorus, and alkaline phosphatase (ALP', 'suppression in CTX-1', 'CTX-1 and higher PTH']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0026136', 'cui_str': 'Milk of Calcium'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1245242', 'cui_str': 'Calcium Carbonate Oral Tablet'}, {'cui': 'C0452453', 'cui_str': 'Fruit juice'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.12623,"At baseline, women with higher VAT had significantly lower CTX-1 and higher PTH (44% lower and 30% higher, respectively between Q4 and Q1, P < 0.0001).","[{'ForeName': 'Deepti K', 'Initials': 'DK', 'LastName': 'Sharma', 'Affiliation': 'Clinical and Health Sciences Academic Unit, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Anderson', 'Affiliation': 'Clinical and Health Sciences Academic Unit, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Howard A', 'Initials': 'HA', 'LastName': 'Morris', 'Affiliation': 'Clinical and Health Sciences Academic Unit, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Clifton', 'Affiliation': 'Clinical and Health Sciences Academic Unit, University of South Australia, Adelaide, Australia.'}]",The Journal of nutrition,['10.1093/jn/nxab384']
2517,34751784,The Manual Therapy and Strengthening for the Hip (MASH) Trial: Protocol for a Multisite Randomized Trial of a Subgroup of Older Adults with Chronic Back and Hip Pain.,"OBJECTIVE


Chronic low back pain (CLBP) is a disabling and costly condition for older adults that is difficult to properly classify and treat. In a cohort study, a subgroup of older adults with CLBP who had elevated hip pain and hip muscle weakness was identified; this subgroup differentiated itself by being at higher risk for future mobility decline. The primary purpose of this clinical trial is to evaluate whether a hip-focused low back pain (LBP) treatment provides better disability and physical performance outcomes for this at-risk group when compared to a spine-focused LBP treatment.
METHODS


This study is a multisite, single-blinded, randomized controlled, parallel arm, Phase II trial conducted across 3 clinical research sites. A total of 180 people between 60 and 85 years of age with CLBP and hip pain are being recruited. Participants undergo a comprehensive baseline assessment and are randomized into 1 of 2 intervention arms: hip-focused or spine-focused. They are treated twice weekly by a licensed physical therapist for 8 weeks and undergo follow-up assessments at 8 weeks and 6 months after randomization. Primary outcome measures include the Quebec Low Back Disability Scale and the 10-Meter Walk Test, which are measures of self-report and performance-based physical function, respectively.
IMPACT


This multicenter, randomized clinical trial will determine whether a hip-focused or spine-focused physical therapist intervention results in improved disability and physical performance for a subgroup of older adults with CLBP and hip pain who are at increased risk of mobility decline. This trial will help further the development of effective interventions for this subgroup of older adults with CLBP.",2021,"This multicenter, randomized clinical trial will determine whether a hip-focused or spine-focused physical therapist intervention results in improved disability and physical performance for a subgroup of older adults with CLBP and hip pain who are at increased risk of mobility decline.","['older adults with CLBP who had elevated hip pain and hip muscle weakness', 'older adults', 'Older Adults with Chronic Back and Hip Pain', '180 people between 60 and 85\xa0years of age with CLBP and hip pain are being recruited', 'older adults with CLBP', 'older adults with CLBP and hip pain who are at increased risk of mobility decline']","['hip-focused or spine-focused', 'hip-focused or spine-focused physical therapist intervention', 'hip-focused low back pain (LBP']","['Quebec Low Back Disability Scale and the 10-Meter Walk Test, which are measures of self-report and performance-based physical function, respectively', 'disability and physical performance', 'disability and physical performance outcomes']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",180.0,0.121377,"This multicenter, randomized clinical trial will determine whether a hip-focused or spine-focused physical therapist intervention results in improved disability and physical performance for a subgroup of older adults with CLBP and hip pain who are at increased risk of mobility decline.","[{'ForeName': 'Jenifer M', 'Initials': 'JM', 'LastName': 'Pugliese', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Coyle', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Knox', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE.'}, {'ForeName': 'J Megan', 'Initials': 'JM', 'LastName': 'Sions', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE.'}, {'ForeName': 'Charity G', 'Initials': 'CG', 'LastName': 'Patterson', 'Affiliation': 'Clinical and Translational Sciences Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Pohlig', 'Affiliation': 'Department of Epidemiology, University of Delaware, PT.'}, {'ForeName': 'Corey B', 'Initials': 'CB', 'LastName': 'Simon', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Geriatric Research Education and Clinical Center, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, PA.'}, {'ForeName': 'Steven Z', 'Initials': 'SZ', 'LastName': 'George', 'Affiliation': 'Duke School of Medicine, Department of Orthopedic Surgery, Durham, NC.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Piva', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Hicks', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE.'}]",Physical therapy,['10.1093/ptj/pzab255']
2518,34751780,What factors are associated with waterpipe smoking cessation? A secondary data analysis.,"INTRODUCTION


Waterpipe smoking is gaining popularity and becoming a major global public health concern. An understanding of factors that predict waterpipe smoking cessation is necessary for targeting tobacco control efforts.
METHODS


This is a secondary data analysis of a randomised controlled-trial comparing the efficacy of varenicline against placebo in helping waterpipe smokers to quit. A total of 510 adult daily waterpipe smokers were recruited to the trial in 2016. Logistic regression models were applied to assess factors (i.e., demographic, environmental, behavioural, and physiological) associated with primary outcome (waterpipe smoking cessation) and secondary outcomes (waterpipe cessation alongside abstinence from cigarette and short-term and long-term waterpipe smoking cessation). Cessation was defined as 7-day point prevalence abstinence from smoking reported at 5,12, and/or 25 weeks follow ups.
RESULTS


Over a period of six months, 189 (39.2%) participants abstained from waterpipe smoking for at least one week. Being male (adjusted odds ratio (aOR):2.99 (95%CI:1.47-6.08)), dual smoker (waterpipe and cigarettes) (aOR:2.98 (95%CI:1.87-4.74)), more withdrawal symptoms measured by the Mood and Physical Symptoms Scale (aOR:1.08 (95%CI:1.02-1.13)), less nicotine dependency measured by Lebanon Waterpipe Dependency Scale (aOR:0.90 (95%CI:0.85-0.96)), having history of quit attempt (aOR:2.14 (95%CI:1.16-3.96)), smoking restriction in the house (aOR:2.69 (95%CI:1.01-7.14)), and not sharing waterpipe with others (aOR:2.72 (95%CI:1.31-5.66)) predicted waterpipe smoking cessation.
CONCLUSIONS


In addition to nicotine dependency, social factors such as home restrictions on smoking, and not sharing waterpipe were identified as predictors of waterpipe smoking cessation. To help waterpipe smokers quit, social environment may be just as or even more important than well-known physical and psychological factors.
IMPLICATIONS


A range of factors, predominantly social factors play a significant role in facilitating or deterring waterpipe smokers from quitting smoking. Our findings suggest that interventions that focus on social as well as physical/psychological factors may encourage waterpipe smokers in achieving abstinence.",2021,"more withdrawal symptoms measured by the Mood and Physical Symptoms Scale (aOR:1.08 (95%CI:1.02-1.13)), less nicotine dependency measured by Lebanon Waterpipe Dependency Scale (aOR:0.90 (95%CI:0.85-0.96)), having history of quit attempt (aOR:2.14 (95%CI:1.16-3.96)), smoking restriction in the house (aOR:2.69 (95%CI:1.01-7.14)), and not sharing waterpipe with others (aOR:2.72 (95%CI:1.31-5.66)) predicted waterpipe smoking cessation.
","['helping waterpipe smokers to quit', '510 adult daily waterpipe smokers']",['varenicline against placebo'],"['Mood and Physical Symptoms Scale', 'smoking restriction', 'withdrawal symptoms', 'waterpipe smoking cessation', 'demographic, environmental, behavioural, and physiological) associated with primary outcome (waterpipe smoking cessation) and secondary outcomes (waterpipe cessation alongside abstinence from cigarette and short-term and long-term waterpipe smoking cessation', 'having history of quit attempt', 'nicotine dependency measured by Lebanon Waterpipe Dependency Scale']","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C4505138', 'cui_str': 'Waterpipe Smoking'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}]",510.0,0.0776858,"more withdrawal symptoms measured by the Mood and Physical Symptoms Scale (aOR:1.08 (95%CI:1.02-1.13)), less nicotine dependency measured by Lebanon Waterpipe Dependency Scale (aOR:0.90 (95%CI:0.85-0.96)), having history of quit attempt (aOR:2.14 (95%CI:1.16-3.96)), smoking restriction in the house (aOR:2.69 (95%CI:1.01-7.14)), and not sharing waterpipe with others (aOR:2.72 (95%CI:1.31-5.66)) predicted waterpipe smoking cessation.
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Shtaiwi', 'Affiliation': 'Freelance Research Consultant, Amman, Jordan.'}, {'ForeName': 'Faraz', 'Initials': 'F', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Health Sciences, University of York, York YO10 5DD, UK.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Kanaan', 'Affiliation': 'Department of Health Sciences, University of York, York YO10 5DD, UK.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Siddiqi', 'Affiliation': 'Department of Health Sciences, University of York, York YO10 5DD, UK.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab234']
2519,34751662,Mechanisms of Smartphone Apps for Cigarette Smoking Cessation: Results of a Serial Mediation Model From the iCanQuit Randomized Trial.,"BACKGROUND


Engagement with digital interventions is a well-known predictor of treatment outcomes, but this knowledge has had limited actionable value. Instead, learning why engagement with digital interventions impact treatment outcomes can lead to targeted improvements in their efficacy.
OBJECTIVE


This study aimed to test a serial mediation model of an Acceptance and Commitment Therapy (ACT) smartphone intervention for smoking cessation.
METHODS


In this randomized controlled trial, participants (N=2415) from 50 US states were assigned to the ACT-based smartphone intervention (iCanQuit) or comparison smartphone intervention (QuitGuide). Their engagement with the apps (primary measure: number of logins) was measured during the first 3 months, ACT processes were measured at baseline and 3 months (acceptance of internal cues to smoke, valued living), and smoking cessation was measured at 12 months with 87% follow-up retention.
RESULTS


There was a significant serial mediation effect of iCanQuit on smoking cessation through multiple indicators of intervention engagement (ie, total number of logins, total number of minutes used, and total number of unique days of use) and in turn through increases in mean acceptance of internal cues to smoke from baseline to 3 months. Analyses of the acceptance subscales showed that the mediation was through acceptance of physical sensations and emotions, but not acceptance of thoughts. There was no evidence that the effect of the iCanQuit intervention was mediated through changes in valued living.
CONCLUSIONS


In this first study of serial mediators underlying the efficacy of smartphone apps for smoking cessation, our results suggest the effect of the iCanQuit ACT-based smartphone app on smoking cessation was mediated through multiple indicators of engagement and in turn through increases in the acceptance of physical sensations and emotions that cue smoking.
TRIAL REGISTRATION


Clinical Trials.gov NCT02724462; https://clinicaltrials.gov/ct2/show/NCT02724462.",2021,"There was a significant serial mediation effect of iCanQuit on smoking cessation through multiple indicators of intervention engagement (ie, total number of logins, total number of minutes used, and total number of unique days of use) and in turn through increases in mean acceptance of internal cues to smoke from baseline to 3 months.","['participants (N=2415) from 50 US states', 'Cigarette Smoking Cessation']","['Acceptance and Commitment Therapy (ACT) smartphone intervention', 'ACT-based smartphone intervention (iCanQuit) or comparison smartphone intervention (QuitGuide', 'smartphone', 'iCanQuit']","['smoking cessation through multiple indicators of intervention engagement (ie, total number of logins, total number of minutes used, and total number of unique days of use', 'internal cues to smoke, valued living), and smoking cessation', 'number of logins', 'mean acceptance of internal cues to smoke']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1562039', 'cui_str': 'Number of minutes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",,0.102808,"There was a significant serial mediation effect of iCanQuit on smoking cessation through multiple indicators of intervention engagement (ie, total number of logins, total number of minutes used, and total number of unique days of use) and in turn through increases in mean acceptance of internal cues to smoke from baseline to 3 months.","[{'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levin', 'Affiliation': 'Department of Psychology, Utah State University, Logan, UT, United States.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Lappalainen', 'Affiliation': 'Department of Psychology, University of Jyvaskyla, Jyvaskyla, Finland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mull', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Sullivan', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Santiago-Torres', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}]",JMIR mHealth and uHealth,['10.2196/32847']
2520,34752019,Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.,"BACKGROUND


Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.
METHODS


A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed.
RESULTS


During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3).
CONCLUSIONS


A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).",2021,No vaccine-related serious adverse events were noted.,"['751 children', '2268 children', 'children 6 months to 11 years of age', 'children 5 to 11 years of age', '5-to-11-year-old children', 'Children 5 to 11 Years of Age', '48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level', 'children younger than 12 years of age', '1517 children) or']","['BNT162b2 Covid-19 Vaccine', 'placebo', 'BNT162b2 vaccine']","['reactogenicity and immunogenicity', 'Vaccine efficacy against Covid-19', 'geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers', 'safety, immunogenicity, and efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2268.0,0.537594,No vaccine-related serious adverse events were noted.,"[{'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Walter', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Kawsar R', 'Initials': 'KR', 'LastName': 'Talaat', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Sabharwal', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Grant C', 'Initials': 'GC', 'LastName': 'Paulsen', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Barnett', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Flor M', 'Initials': 'FM', 'LastName': 'Muñoz', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Maldonado', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Pahud', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Domachowske', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Uzma N', 'Initials': 'UN', 'LastName': 'Sarwar', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Cunliffe', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rojo', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Kuchar', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Rämet', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Iona', 'Initials': 'I', 'LastName': 'Munjal', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Perez', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Frenck', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Lagkadinou', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Koury', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mather', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Belanger', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Türeci', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Şahin', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2116298']
2521,34751928,Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS.,"BACKGROUND AND OBJECTIVES


In clinical trials, the safety of drugs is summarized by the incidence of adverse events, while post-marketing reporting systems use disproportionate reporting of adverse drug reactions. Here, we propose a method to evaluate the novelty of a safety profile of a drug in a new class (in clinical trials), against that of those already on the market (using pharmacovigilance data).
METHODS


Through Bayesian disproportionality analyses of the US Food and Drug Administration Adverse Event Reporting System (FAERS) data, we identified and ranked Preferred Terms for a pool of 30 antipsychotics. Adverse event rates in randomized, double-blind, placebo-controlled schizophrenia clinical trials were summarized by their class specificity. One study (N = 245) of the trace amine-associated receptor 1 (TAAR1) agonist ulotaront (SEP-363856) was compared with five studies of dopamine D2 receptor-based antipsychotics lurasidone (N = 1041), quetiapine (N = 119), olanzapine (N = 122), and placebo (N = 504).
RESULTS


In clinical trials of antipsychotics, cumulative rates for adverse events at and above a threshold of disproportional reporting (Empirical Bayes Geometric Mean 50 > 3 in FAERS) were 52%, 42%, and 60% for lurasidone, quetiapine, and olanzapine, respectively, indicating that over half of the adverse events reported in clinical trials of an atypical antipsychotic are class-specific risks. In contrast, in the clinical trial of ulotaront, the cumulative rate was 23%, indicating a lower rate of antipsychotic class-specific risk.
CONCLUSIONS


These results demonstrate a novel approach to summarize adverse events in clinical trials, where the cumulative burden of class-specific risks describes the emerging safety profile of a new drug in clinical development, relative to reactions anticipated for drugs in an established pharmacological class. CLINICALTRIALS.
GOV IDENTIFIERS


NCT0296938, NCT00088634, NCT00549718, NCT00615433, NCT00790192.",2021,"One study (N = 245) of the trace amine-associated receptor 1 (TAAR1) agonist ulotaront (SEP-363856) was compared with five studies of dopamine D2 receptor-based antipsychotics lurasidone (N = 1041), quetiapine (N = 119), olanzapine (N = 122), and placebo (N = 504).
",[],"['trace amine-associated receptor 1\xa0(TAAR1) agonist ulotaront (SEP-363856', 'quetiapine', 'TAAR1', 'placebo', 'olanzapine', 'dopamine D2 receptor-based antipsychotics lurasidone']","['Adverse event rates', 'cumulative rate']",[],"[{'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0002508', 'cui_str': 'Amine'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0058698', 'cui_str': 'Dopamine-D2 Receptor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.58756,"One study (N = 245) of the trace amine-associated receptor 1 (TAAR1) agonist ulotaront (SEP-363856) was compared with five studies of dopamine D2 receptor-based antipsychotics lurasidone (N = 1041), quetiapine (N = 119), olanzapine (N = 122), and placebo (N = 504).
","[{'ForeName': 'Seth C', 'Initials': 'SC', 'LastName': 'Hopkins', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA. seth.hopkins@sunovion.com.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Ogirala', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.'}, {'ForeName': 'MaryAlice', 'Initials': 'M', 'LastName': 'Worden', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.'}, {'ForeName': 'Kenneth S', 'Initials': 'KS', 'LastName': 'Koblan', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.'}]",Clinical drug investigation,['10.1007/s40261-021-01094-7']
2522,33345573,Positron Emission Tomography Combined With Computed Tomography vs. No Positron Emission Tomography Combined With Computed Tomography for the Management of Patients With Resectable Colorectal Cancer Liver Metastases and Synchronous Extrahepatic Disease.,"INTRODUCTION


Selected patients with colorectal cancer liver metastases (CRLM) and synchronous extrahepatic disease (EHD) are considered for surgery.
OBJECTIVES


To evaluate the change in surgical management and long-term survival (disease-free survival [DFS] and overall survival [OS]) for patients with CRLM and EHD who undergo positron emission tomography combined with computed tomography (PET-CT) vs no PET-CT.
METHODS


Patients with CRLM were enrolled in a trial evaluating the effect of PET-CT (vs no PET-CT) on surgical management, DFS, and OS. This is a sub-study of the trial, including only patients with synchronous EHD. Cox proportional hazard models were used to calculate risks for recurrence and death. Survival were described by Kaplan-Meier method and compared with log-rank test.
RESULTS


Of 25 patients with EHD (PET-CT arm: 14/270 (5%) and no PET-CT arm: 11/134 (8%)), PET-CT changed surgical management in 14%, all of which avoided liver resection due to more extensive disease. Complete metastasectomy was achieved in 36% (5/14) and 72% (8/11), respectively. Respectively, PET-CT vs no PET-CT had statistically similar median DFS, 5.6 months (95% confidence interval (CI) 3.6-18) vs 7.6 months (95% CI 2.9-15) and median OS, 42 months (95% CI 25-48) vs 29 months (95% CI 17-41). EHD was associated with worse DFS (hazard ratio HR = 1.89, 95% CI 1.41-2.52) and OS (HR = 2.47, 95% CI 1.6-3.83).
CONCLUSIONS


Preoperative PET-CT for the management of resectable CRLM did not improve long-term outcomes among patients who had synchronous EHD; however, it changed surgical management in a relatively significant proportion of patients.",2021,"EHD was associated with worse DFS (hazard ratio HR = 1.89, 95% CI 1.41-2.52) and OS (HR = 2.47, 95% CI 1.6-3.83).
","['patients with CRLM and EHD who undergo', 'Patients', 'With Resectable Colorectal Cancer Liver Metastases and Synchronous Extrahepatic Disease', 'patients with colorectal cancer liver metastases (CRLM) and synchronous extrahepatic disease (EHD', 'patients with synchronous EHD', 'Patients with CRLM']","['PET-CT (vs no PET-CT', 'Positron Emission Tomography Combined With Computed Tomography vs. No Positron Emission Tomography', 'Computed Tomography', 'positron emission tomography combined with computed tomography (PET-CT) vs no PET-CT']","['median DFS', 'Survival', 'surgical management and long-term survival (disease-free survival [DFS] and overall survival [OS', 'Complete metastasectomy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}]","[{'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}]",25.0,0.141499,"EHD was associated with worse DFS (hazard ratio HR = 1.89, 95% CI 1.41-2.52) and OS (HR = 2.47, 95% CI 1.6-3.83).
","[{'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Serrano', 'Affiliation': 'Department of Surgery, 153004McMaster University, Canada.'}, {'ForeName': 'Chu-Shu', 'Initials': 'CS', 'LastName': 'Gu', 'Affiliation': 'Ontario Clinical Oncology Group, McMaster University, Canada.'}, {'ForeName': 'Carol-Anne', 'Initials': 'CA', 'LastName': 'Moulton', 'Affiliation': '30133University Health Network, Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Gallinger', 'Affiliation': '30133University Health Network, Canada.'}]",The American surgeon,['10.1177/0003134820954834']
2523,32928003,COPD Maintenance Therapy with Tiotropium/Olodaterol Compared with Tiotropium: An Analysis in the Absence of Additional ICS Therapy.,"The American Thoracic Society guidelines recommend long-acting β 2 -agonist (LABA)/long-acting muscarinic antagonist (LAMA) dual bronchodilation over LAMA or LABA monotherapy as maintenance therapy for patients with chronic obstructive pulmonary disease suffering from dyspnea or exercise intolerance. Previous studies, which included patients receiving background inhaled corticosteroids (ICS), have shown the benefits of dual bronchodilation over monotherapy. This analysis aimed to confirm the benefits of LAMA/LABA over LAMA alone, without any confounding effects from ICS use. This pooled  post hoc  analysis compared the efficacy of tiotropium/olodaterol with tiotropium alone in patients from the TONADO ®  and OTEMTO ®  clinical trials who were not receiving ICS at study entry or during the studies. We analyzed change from baseline in trough forced expiratory volume in 1 s (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) score and Transition Dyspnea Index (TDI) score in all patients, by Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage, baseline SGRQ score, and Baseline Dyspnea Index score. In this analysis of 1596 patients, tiotropium/olodaterol improved trough FEV 1 , SGRQ and TDI compared with tiotropium alone. The observed mean differences were: trough FEV 1 , 0.054 L (95% confidence interval [CI] 0.036, 0.073;  p  < 0.001); SGRQ, -1.918 (95% CI -2.994, -0.843;  p  < 0.001); and TDI, 0.575 (95% CI 0.301, 0.848;  p  < 0.001). Similar improvements were seen in each of the subgroup analyses. Tiotropium/olodaterol therapy significantly improved lung function, symptoms and health status compared with tiotropium alone. In a population free from ICS treatment, these data confirm the benefits of dual bronchodilation versus monotherapy.",2020,"Tiotropium/olodaterol therapy significantly improved lung function, symptoms and health status compared with tiotropium alone.","['1596 patients', 'patients with chronic obstructive pulmonary disease suffering from dyspnea or exercise intolerance', 'patients from the TONADO ®  and OTEMTO ®  clinical trials who were not receiving ICS at study entry or during the studies']","['background inhaled corticosteroids (ICS', 'Tiotropium/Olodaterol', 'tiotropium/olodaterol', 'Tiotropium', 'Tiotropium/olodaterol therapy', 'LAMA/LABA', 'tiotropium/olodaterol with tiotropium', 'tiotropium', 'agonist (LABA)/long-acting muscarinic antagonist (LAMA) dual bronchodilation over LAMA or LABA monotherapy']","[""trough forced expiratory volume in 1\u2009s (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) score and Transition Dyspnea Index (TDI) score"", 'lung function, symptoms and health status', 'Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage, baseline SGRQ score, and Baseline Dyspnea Index score', 'trough FEV 1 , SGRQ and TDI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0424551', 'cui_str': 'Impaired exercise tolerance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}]",1596.0,0.629484,"Tiotropium/olodaterol therapy significantly improved lung function, symptoms and health status compared with tiotropium alone.","[{'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Alberto de la', 'Initials': 'A', 'LastName': 'Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miravitlles', 'Affiliation': ""Pneumology Department, Hospital Universitari Vall d'Hebron/Vall d'Hebron Research Institute (VHIR), CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.""}]",COPD,['10.1080/15412555.2020.1813269']
2524,34725095,Home based rehabilitation after a knee replacement is as effective as physiotherapy.,"The studyBarker KL, Room J, Knight R, et al. Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT.  Health Technol Assess  2020;24:1-116.To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/knee-replacements-home-based-rehabilitation-as-effective-physiotherapy/.",2021,Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT.  ,['patients at risk of poor outcomes after knee arthroplasty'],"['https://evidence.nihr.ac.uk/alert/knee-replacements-home-based-rehabilitation-as-effective-physiotherapy', 'Outpatient physiotherapy versus home-based rehabilitation']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]",[],,0.0206526,Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT.  ,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Saul', 'Affiliation': 'NIHR Centre for Engagement and Dissemination, Twickenham, UK.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Gursul', 'Affiliation': 'NIHR Centre for Engagement and Dissemination, Twickenham, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj.n2593']
2525,34756733,Evaluation of condylar position in anterior mandibular fractures using 3 dimensional miniplate osteosynthesis versus conventional miniplates: Randomized clinical trial.,"To compare clinically and radiographically between the 3-D plates and the conventional two Champy's miniplates in the treatment of anterior mandibular fractures. It is a randomized clinical and radiographic comparative study between 2 equal groups of patients with isolated anterior mandibular fractures. Open reduction and internal rigid fixation was accomplished in the study group using 3D miniplates fixation while in the control group using the two Champy's miniplates. The 3D miniplate osteosynthesis consumed less operative time than the two miniplates osteosynthesis. Independent t-test revealed that the difference between the 2 groups was 8.4 ± 3.11 min. This difference was statistically significant (p=0.012). Occlusion was slightly disturbed in two patients in the study group in comparison to three patients in the control group. The difference between the 2 groups was not statistically significant (p=0.62). None of the cases of both groups showed mobility between the reduced and fixed fractured segments, immediately post-operatively and at the end of follow-up intervals. The 3D miniplate osteosynthesis (study group) recorded less intercondylar distance than two miniplates osteosynthesis (control group) immediately post-operatively and after 3 months. Independent t-test revealed that the difference between the 2 groups was not statistically significant, immediately postoperative (p=0.322) and after 3 months (p=0.263). Pre-operatively to 3 months postoperatively, the 3D miniplate osteosynthesis (study group) recorded a lower median percent increase in the intercondylar distance than the two miniplates osteosynthesis (control group). The difference between the 2 groups was not statistically significant (p=0.917). Regarding the intercondylar angle, the3D miniplate osteosynthesis (study group) recorded higher intercondylar angle than the two miniplates osteosynthesis (control group) immediately post-operative (p=0.333) and after 3 months (p=0.255). Independent t-test revealed that the difference between the 2 groups was not statistically significant. The 3-Dimensional strut miniplates should be considered an alternative for internal rigid fixation of anterior mandibular fractures for their ease of adaptation and insertion, while providing the advantage of reduced operative time compared to the conventional two Champy's miniplates.",2021,"None of the cases of both groups showed mobility between the reduced and fixed fractured segments, immediately post-operatively and at the end of follow-up intervals.","['2 equal groups of patients with isolated anterior mandibular fractures', 'anterior mandibular fractures']",['dimensional miniplate osteosynthesis versus conventional miniplates'],"['Occlusion', 'operative time', 'intercondylar distance', 'Open reduction and internal rigid fixation']","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}]","[{'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",,0.024799,"None of the cases of both groups showed mobility between the reduced and fixed fractured segments, immediately post-operatively and at the end of follow-up intervals.","[{'ForeName': 'Omar Al-Husseiny', 'Initials': 'OA', 'LastName': 'Mohammad', 'Affiliation': 'Resident of Oral and Maxillofacial Surgery, Faculty of Dentistry, October 6 University, Giza, Egypt; M.Sc. of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Cairo, Egypt. Electronic address: omar.alhusseiny.mohammad@gmail.com.'}, {'ForeName': 'Essam Mohamed', 'Initials': 'EM', 'LastName': 'Ashour', 'Affiliation': 'Associate Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, October 6 University, Giza, Egypt.'}, {'ForeName': 'Fahmy Abd-El Aal', 'Initials': 'FAA', 'LastName': 'Hassanein', 'Affiliation': 'Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2021.09.014']
2526,34756706,Agreement Between A 2-Dimensional Digital Image-Based 3-Compartment Body Composition Model and Dual Energy X-Ray Absorptiometry for The Estimation of Relative Adiposity.,"The purpose of this study was to compare relative adiposity (%Fat) derived from a 2-dimensional image-based 3-component (3C) model (%Fat 3C-IMAGE ) and dual-energy X-ray absorptiometry (DXA) (%Fat DXA ) against a 5-component (5C) laboratory criterion (%Fat 5C ). 57 participants were included (63.2% male, 84.2% White/Caucasian, 22.5±4.7 yrs., 23.9±2.8 kg/m 2 ). For each participant, body mass and standing height were measured to the nearest 0.1 kg and 0.1 cm, respectively. A digital image of each participant was taken using a 9.7 inch, 16g iPad Air 2 and analyzed using a commercially available application (version 1.1.2, made Health and Fitness, USA) for the estimation of body volume (BV) and inclusion in %Fat 3C-IMAGE  . %Fat 3C-IMAGE  and %Fat 5C  included measures of total body water derived from bioimpedance spectroscopy. The criterion %Fat 5C  included BV estimates derived from underwater weighing and bone mineral content measures via DXA. %Fat DXA  estimates were calculated from a whole-body DXA scan. A standardized mean effect size (ES) assessed the magnitude of differences between models with values of 0.2, 0.5, and 0.8 for small, moderate, and large differences, respectively. Data are presented as mean ± standard deviation. A strong correlation (r = 0.94, p <.001) and small mean difference (ES = 0.24, p <.001) was observed between %Fat 3C-IMAGE  (19.20±5.80) and %Fat 5C  (17.69±6.20) whereas a strong correlation (r = 0.87, p <.001) and moderate-large mean difference (ES = 0.70, p <.001) was observed between %Fat DXA  (22.01±6.81) and %Fat 5C . Furthermore, %Fat 3C-IMAGE  (SEE = 2.20 %Fat, TE= 2.6) exhibited smaller SEE and TE than %Fat DXA  (SEE = 3.14 %Fat, TE = 5.5). The 3C image-based model performed slightly better in our sample of young adults than the DXA 3C model. Thus, the 2D image analysis program provides an accurate and non-invasive estimate of %Fat within a 3C model in young adults. Compared to DXA, the 3C image-based model allows for a more cost-effective and portable method of body composition assessment, potentially increasing accessibility to multi-component methods.",2021,The 3C image-based model performed slightly better in our sample of young adults than the DXA 3C model.,"['57 participants were included (63.2% male, 84.2% White/Caucasian, 22.5±4.7 yrs', 'young adults']","['2-dimensional image-based 3-component (3C) model (%Fat 3C-IMAGE ) and dual-energy X-ray absorptiometry (DXA) (%Fat DXA ', 'Fat 3C-IMAGE  (SEE', '2-Dimensional Digital Image-Based 3-Compartment Body Composition Model and Dual Energy X-Ray Absorptiometry']","['body mass and standing height', 'relative adiposity']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043157', 'cui_str': 'Caucasian'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",57.0,0.0164786,The 3C image-based model performed slightly better in our sample of young adults than the DXA 3C model.,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Sullivan', 'Affiliation': 'Department of Kinesiology, The University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Casey J', 'Initials': 'CJ', 'LastName': 'Metoyer', 'Affiliation': 'Department of Kinesiology, The University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Hornikel', 'Affiliation': 'Department of Kinesiology, The University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Clifton J', 'Initials': 'CJ', 'LastName': 'Holmes', 'Affiliation': 'Department of Kinesiology, The University of Alabama, Tuscaloosa, Alabama, USA; Program in Physical Therapy, School of Medicine, Washington University, Saint Louis, Missouri, USA.'}, {'ForeName': 'Brett S', 'Initials': 'BS', 'LastName': 'Nickerson', 'Affiliation': 'College of Nursing and Health Sciences, Texas A&M International University, Laredo, Texas, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Esco', 'Affiliation': 'Department of Kinesiology, The University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Fedewa', 'Affiliation': 'Department of Kinesiology, The University of Alabama, Tuscaloosa, Alabama, USA. Electronic address: mvfedewa@ua.edu.'}]",Journal of clinical densitometry : the official journal of the International Society for Clinical Densitometry,['10.1016/j.jocd.2021.08.004']
2527,34756698,Comparison of dose delivered to vagina using two different intracavitary brachytherapy applicators for carcinoma cervix.,"PURPOSE


The aim of the study was to compare the dose to vaginal points between two intracavitary applicators used for HDR brachytherapy in Carcinoma Cervix METHODS AND MATERIALS: Patients reporting to our center for Carcinoma cervix intracavitary brachytherapy were randomly allocated to treatment with either Manchester or Fletcher Suit Delclos (FSD) applicator. All patients received an EBRT dose of 50 Gy in 25 fractions along with weekly Cisplatin (40 mg/m 2 ). Brachytherapy was administered using CT based planning. All patients received a dose of 7 Gy to Point A one week apart for a total of three fractions. For vaginal dose reporting, the PIBS points (PIBS, PIBS+1, PIBS+2, PIBS-1, PIBS-2) and dose to vagina at the level of ovoids was compared between the two applicators RESULTS: A total of 30 Carcinoma cervix patients were randomly allocated to receive intracavitary brachytherapy with either Manchester or FSD applicator. The mean vaginal reference length for patients treated with Manchester applicator was 4.3 and for patients treated with FSD applicator was 4.4. On analyzing dose to different vaginal points, patients treated with Manchester applicator received significantly higher mean and median doses to all PIBS points (except PIBS-2 cm) as compared to FSD applicator. On analyzing dose to the upper vagina at the level of the ovoids, the Manchester applicator delivered higher antero-posterior doses as compared to FSD applicator.
CONCLUSIONS


Manchester applicator gives higher dose to the vagina as compared to FSD applicator for intracavitary brachytherapy in Carcinoma Cervix. The choice of using a particular applicator depends on the residual disease at the time of brachytherapy and patient anatomy.",2021,"CONCLUSIONS


Manchester applicator gives higher dose to the vagina as compared to FSD applicator for intracavitary brachytherapy in Carcinoma Cervix.","['Carcinoma Cervix', 'carcinoma cervix', 'Patients reporting to our center for Carcinoma cervix intracavitary brachytherapy', '30 Carcinoma cervix patients']","['Cisplatin', 'Brachytherapy', 'HDR brachytherapy', 'intracavitary brachytherapy applicators', 'intracavitary brachytherapy', 'Manchester or Fletcher Suit Delclos (FSD) applicator']","['mean vaginal reference length', 'PIBS points (PIBS, PIBS+1, PIBS+2, PIBS-1, PIBS-2) and dose to vagina']","[{'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0021864', 'cui_str': 'Intracavitary brachytherapy'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0021864', 'cui_str': 'Intracavitary brachytherapy'}, {'cui': 'C0179108', 'cui_str': 'Applicator'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0097150', 'cui_str': '4-iodobenzenesulfonamide'}, {'cui': 'C1568156', 'cui_str': 'Pittsburgh compound B'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",30.0,0.0229056,"CONCLUSIONS


Manchester applicator gives higher dose to the vagina as compared to FSD applicator for intracavitary brachytherapy in Carcinoma Cervix.","[{'ForeName': 'Harjot Kaur', 'Initials': 'HK', 'LastName': 'Bajwa', 'Affiliation': 'Department of Radiation Oncology, Basavatarakam Indo American, Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Talluri', 'Affiliation': 'Department of Radiation Physics, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Aijaz', 'Initials': 'A', 'LastName': 'Maqbool', 'Affiliation': 'Department of Radiation Oncology, Basavatarakam Indo American, Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Devender', 'Initials': 'D', 'LastName': 'Reddy', 'Affiliation': 'Department of Radiation Physics, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Rohith', 'Initials': 'R', 'LastName': 'Singareddy', 'Affiliation': 'Department of Radiation Oncology, Basavatarakam Indo American, Cancer Hospital and Research Institute, Hyderabad, Telangana, India. Electronic address: rohithsingareddy@gmail.com.'}, {'ForeName': 'Nvn Madhusudhana', 'Initials': 'NM', 'LastName': 'Sresty', 'Affiliation': 'Department of Radiation Physics, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Alluri Krishnam', 'Initials': 'AK', 'LastName': 'Raju', 'Affiliation': 'Department of Radiation Oncology, Basavatarakam Indo American, Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}]",Brachytherapy,['10.1016/j.brachy.2021.09.004']
2528,34756645,Clinical outcomes of potential high responders after individualized FSH dosing based on anti-Müllerian hormone and body weight.,"RESEARCH QUESTION


How does the efficacy and safety of individualized follitropin delta dosing compare with conventional dosing for ovarian stimulation in potential high responders?
DESIGN


Retrospective analysis of 153 potential high responders identified on the basis of baseline serum anti-Müllerian hormone (AMH) levels above 35 pmol/l, who were originally randomized to an individualized fixed dose of follitropin delta based on AMH and body weight (n = 78) or to a daily starting dose of 150 IU follitropin alfa (n = 75).
RESULTS


At the end of stimulation, patients treated with individualized follitropin delta or conventional follitropin alfa had 12.1 ± 7.0 and 18.3 ± 7.0 (P < 0.001) follicles measuring 12 mm or wider, and 27.3% and 62.7% had serum progesterone levels higher than 3.18 nmol/l (P < 0.001), respectively. Overall number of oocytes in these two respective arms was 9.3 ± 6.7 and 17.9 ± 8.7 (P < 0.001), and the ongoing pregnancy rate per started cycle after fresh blastocyst transfer was 28.2% and 24.0%. The risk of ovarian hyperstimulation syndrome (OHSS) for all cases was three times higher in the conventional follitropin alfa arm at 16.0% versus 5.1% with individualized follitropin delta treatment (P = 0.025) and 26.7% versus 7.7% (P = 0.001) for early moderate or severe OHSS, preventive interventions for early OHSS, or both.
CONCLUSIONS


Treatment with individualized follitropin delta provides an improved efficacy-safety balance in women with high ovarian reserve, as it normalizes the ovarian response and decreases the risk of OHSS without compromising the chance of pregnancy.",2021,"The risk of ovarian hyperstimulation syndrome (OHSS) for all cases was three times higher in the conventional follitropin alfa arm at 16.0% versus 5.1% with individualized follitropin delta treatment (P = 0.025) and 26.7% versus 7.7% (P = 0.001) for early moderate or severe OHSS, preventive interventions for early OHSS, or both.
","['women with high ovarian reserve', '153 potential high responders identified on the basis of baseline serum anti-Müllerian hormone (AMH) levels above 35 pmol/l']","['follitropin delta based on AMH and body weight (n\u202f=\u202f78) or to a daily starting dose of 150 IU follitropin alfa', 'individualized follitropin delta or conventional follitropin alfa']","['ongoing pregnancy rate', 'anti-Müllerian hormone and body weight', 'Overall number of oocytes', 'risk of ovarian hyperstimulation syndrome (OHSS', 'serum progesterone levels', 'efficacy-safety balance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439284', 'cui_str': 'pmol/L'}]","[{'cui': 'C4301617', 'cui_str': 'follitropin delta'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1268876', 'cui_str': 'Follitropin Alfa'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",153.0,0.0564744,"The risk of ovarian hyperstimulation syndrome (OHSS) for all cases was three times higher in the conventional follitropin alfa arm at 16.0% versus 5.1% with individualized follitropin delta treatment (P = 0.025) and 26.7% versus 7.7% (P = 0.001) for early moderate or severe OHSS, preventive interventions for early OHSS, or both.
","[{'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Višnová', 'Affiliation': 'IVF Cube, Fertility Clinic, Evropská 423, Prague 160 00, Czech Republic.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Papaleo', 'Affiliation': 'IRCCS San Raffaele Hospital, Via Olgettina 60, Milan 20132.'}, {'ForeName': 'Fernando Sánchez', 'Initials': 'FS', 'LastName': 'Martin', 'Affiliation': 'Ginemed, Calle Farmaceutico Murillo Herrera 3 Sevilla 41010, Spain.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Koziol', 'Affiliation': 'nOvum Fertility Clinic, Bociania 13 Warsaw 02-807, Poland.'}, {'ForeName': 'Bjarke M', 'Initials': 'BM', 'LastName': 'Klein', 'Affiliation': 'Ferring Pharmaceuticals, Global Biometrics, Kay Fiskers Plads 11, Copenhagen DK-2300, Denmark.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Mannaerts', 'Affiliation': 'Ferring Pharmaceuticals, Reproductive Medicine and Maternal Health, Kay Fiskers Plads 11, Copenhagen DK-2300, Denmark. Electronic address: Bernadette.Mannaerts@ferring.com.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2021.08.024']
2529,34756640,Evaluation of the efficiency of different treatment modalities in individuals with painful temporomandibular joint disc displacement with reduction: a randomised controlled clinical trial.,"The aim of the study was to investigate and compare short and long-term effects of occlusal splints (OS), ultrasound (US), and high-intensity laser therapy (HILT) in patients with painful temporomandibular joint (TMJ) disc displacement with reduction (DDWR). This prospective, randomised, single-blinded, controlled clinical study was conducted on patients with DDWR at a university oral and maxillofacial surgery clinic. A total of 140 patients were allocated randomly to four groups (OS, US, HILT, and control), with 35 patients in each. Patients were evaluated for pain, range of motion of the jaw, disability, and quality of life. A total of 132 patients completed the study. In all treatment groups (OS, US, and HILT), a significant improvement was observed in terms of pain, function, disability, and quality of life, at both weeks four and 12 compared with the control group (p < 0.001). Improvements in VAS pain and maximum mouth opening were not significantly different between the treatment groups. However, compared with the OS group, there was a significant improvement in the HILT and US groups in terms of total Oral Health Impact Profile (OHIP-14) and Jaw Functional Limitation Scale-20 (JFLS-20) scores at week four, but no difference between the groups at week 12. The results of this study show that OS, US, and HILT are effective treatments for pain and functional jaw movements in patients with DDWR. HILT, a new method, can be an alternative treatment in cases of TMD.",2021,"In all treatment groups (OS, US, and HILT), a significant improvement was observed in terms of pain, function, disability, and quality of life, at both weeks four and 12 compared with the control group (p < 0.001).","['140 patients', 'patients with DDWR at a university oral and maxillofacial surgery clinic', 'individuals with painful temporomandibular joint disc displacement with reduction', 'patients with painful temporomandibular joint (TMJ) disc displacement with reduction (DDWR', 'patients with DDWR', '132 patients completed the study']","['occlusal splints (OS), ultrasound (US), and high-intensity laser therapy (HILT']","['total Oral Health Impact Profile (OHIP-14) and Jaw Functional Limitation Scale-20 (JFLS-20) scores', 'VAS pain and maximum mouth opening', 'pain and functional jaw movements', 'pain, function, disability, and quality of life', 'pain, range of motion of the jaw, disability, and quality of life']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1552440', 'cui_str': 'Oral and maxillofacial surgery clinic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1290686', 'cui_str': 'Temporomandibular joint disc displacement'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0596807', 'cui_str': 'Moving jaw'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",140.0,0.0104732,"In all treatment groups (OS, US, and HILT), a significant improvement was observed in terms of pain, function, disability, and quality of life, at both weeks four and 12 compared with the control group (p < 0.001).","[{'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Ekici', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey. Electronic address: omer.ekici@afsu.edu.tr.'}, {'ForeName': 'Ümit', 'Initials': 'Ü', 'LastName': 'Dündar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey.'}, {'ForeName': 'Gonca Deste', 'Initials': 'GD', 'LastName': 'Gökay', 'Affiliation': 'Department of Prosthetic Dentistry, Faculty of Dentistry, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Büyükbosna', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2021.08.001']
2530,34756613,Effect of inactivated influenza vaccination on human coronavirus infection: Secondary analysis of a randomized trial in Hutterite colonies.,"BACKGROUND


Although influenza vaccines provide protection against influenza viruses, concern has been raised that they may increase susceptibility to non-influenza respiratory viruses. As pandemic lockdowns end, temporal overlap of circulation of seasonal influenza viruses and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is expected. Understanding the impact of influenza vaccination on risk of coronavirus infection is therefore of considerable public health importance.
METHODS


We performed a secondary analysis of a randomized trial where children and adolescents in Canadian Hutterite colonies were randomly assigned by colony to receive the 2008-2009 seasonal inactivated trivalent influenza vaccine (TIV) or a control hepatitis A (HepA) vaccine. All 3273 colony members (vaccinated children and nonvaccine recipients) were followed for the primary outcome of RT-PCR confirmed seasonal coronavirus infection. Serum collected pre- and post-vaccination was analyzed for titers of IgG antibodies towards human coronaviruses (HCoV).
RESULTS


The incidence of coronavirus infection was 0·18/1000 person-days in the colonies that received TIV vs 0.36/1000 person-days in the control group, hazard ratio (HR) 0.49 [0.21-1.17]. The risk reduction among non-vaccine recipients in the TIV group compared to the control group was HR 0.55 [0.24-1.23]. There was an increase in the geometric mean fold change of HCoV-OC43 antibody titers following TIV compared to HepA vaccine (mean difference 1.2 [0.38-2.06], p = 0.007), and an increase in geometric mean HCoV-NL63 antibody titers post-TIV (262.9 vs 342.9, p = 0.03).
CONCLUSION


The influenza vaccine does not increase the risk of a coronavirus infection. Instead, the influenza vaccine may reduce the rate of coronavirus infections by inducing cross-reactive anti-coronavirus IgG antibodies.",2021,"Serum collected pre- and post-vaccination was analyzed for titers of IgG antibodies towards human coronaviruses (HCoV).
","['human coronavirus infection', 'All 3273 colony members (vaccinated children and nonvaccine recipients', 'children and adolescents in Canadian Hutterite colonies']","['influenza vaccination', '2008-2009 seasonal inactivated trivalent influenza vaccine (TIV) or a control hepatitis A (HepA) vaccine', 'influenza vaccine', 'inactivated influenza vaccination']","['risk of a coronavirus infection', 'geometric mean HCoV-NL63 antibody titers post-TIV', 'rate of coronavirus infections', 'risk reduction', 'geometric mean fold change of HCoV-OC43 antibody titers']","[{'cui': 'C0206422', 'cui_str': 'Human coronavirus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019159', 'cui_str': 'Viral hepatitis, type A'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0206750', 'cui_str': 'Coronavirus infection'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1478824', 'cui_str': 'Human coronavirus NL63'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0949881', 'cui_str': 'Human coronavirus OC43'}]",,0.151426,"Serum collected pre- and post-vaccination was analyzed for titers of IgG antibodies towards human coronaviruses (HCoV).
","[{'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Hannah D', 'Initials': 'HD', 'LastName': 'Stacey', 'Affiliation': 'Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, ON, Canada; Michael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada; McMaster Immunology Research Centre, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Art', 'Initials': 'A', 'LastName': 'Marzok', 'Affiliation': 'Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, ON, Canada; Michael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada; McMaster Immunology Research Centre, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Pardeep', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jann', 'Initials': 'J', 'LastName': 'Ang', 'Affiliation': 'Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, ON, Canada; Michael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada; McMaster Immunology Research Centre, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Miller', 'Affiliation': 'Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, ON, Canada; Michael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada; McMaster Immunology Research Centre, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Loeb', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada; Michael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada; Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada; Department of Mathematics and Statistics, McMaster University, Hamilton, ON, Canada. Electronic address: loebm@mcmaster.ca.'}]",Vaccine,['10.1016/j.vaccine.2021.10.021']
2531,34756607,Performance of complete dentures fabricated with the simplified and the traditional technique: A randomized clinical trial.,"STATEMENT OF PROBLEM


The simplified technique has been recommended for the fabrication of removable complete dentures. However, a consensus regarding the performance of the simplified and the traditional techniques is lacking.
PURPOSE


The purpose of this randomized clinical trial was to compare the performance of prostheses fabricated with the simplified and the traditional techniques.
MATERIAL AND METHODS


Sixty participants were recruited and randomized into 2 groups: traditional technique (control group) and simplified technique (experimental group). The assessments were performed before treatment (baseline) and 2 and 4 months after adaptation to the new complete dentures. The variables evaluated were satisfaction, oral health-related quality of life (OHRQoL) by using the Brazilian version of the OHIP-EDENT, the quality of the prostheses, and, for the functional assessment, the masticatory performance and swallowing threshold. The data were analyzed by the Fisher exact test, the Mann-Whitney test, and the generalized equations estimating (GEE) method.
RESULTS


At baseline, the mean ±standard deviation quality of the prostheses was 5.3 ±2.3 for the traditional technique and 4.9 ±2.3 for the simplified technique, and at 4 months, it was 9.3 ±0.9 and 9.1 ±0.9, respectively. For masticatory performance, the mean ±standard deviation X 50  at baseline was 5.7 ±1.4 for the traditional technique and 5.7 ±0.9 for the simplified technique, and at 4 months, it was 3.8 ±1.2 and 3.7 ±0.9, respectively. The mean ±standard deviation OHRQoL at baseline was 14.1 ±8.6 for the traditional technique and 12.5 ±9.4 for the simplified technique, and at 4 months, it was 3.2 ±4.3 and 2.6 ±5.1, respectively. The mean ±standard deviation satisfaction at baseline was 9.5 ±3.9 for the traditional technique and 9.3 ±4.2 for the simplified technique; after 4 months, it was 14.8 ±2.0 for both techniques. There was a significant improvement (P<.05) for all variables in the study when comparing them at the baseline to those at the evaluation after provision of new complete dentures. There was no significant difference in all analyzed variables (P>.05) between the 2 techniques for prosthesis fabrication.
CONCLUSIONS


The simplified technique appears to be a suitable alternative to the traditional technique for the fabrication of complete dentures, with similar performance.",2021,There was a significant improvement (P<.05) for all variables in the study when comparing them at the baseline to those at the evaluation after provision of new complete dentures.,['Sixty participants'],['traditional technique (control group) and simplified technique (experimental group'],"['mean ±standard deviation satisfaction', 'satisfaction, oral health-related quality of life (OHRQoL) by using the Brazilian version of the OHIP-EDENT, the quality of the prostheses, and, for the functional assessment, the masticatory performance and swallowing threshold', 'mean ±standard deviation OHRQoL', 'mean ±standard deviation quality']",[],"[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",60.0,0.0999808,There was a significant improvement (P<.05) for all variables in the study when comparing them at the baseline to those at the evaluation after provision of new complete dentures.,"[{'ForeName': 'Francisco Mauro da Silva', 'Initials': 'FMDS', 'LastName': 'Girundi', 'Affiliation': 'PhD student, Department of Prosthodontics and Periodontology, Piracicaba Dental School, State University of Campinas, Piracicaba, São Paulo, Brazil; Professor, Departmet of Odontology, Newton Paiva School of Dentistry, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Raissa Micaella', 'Initials': 'RM', 'LastName': 'Marcello-Machado', 'Affiliation': 'Post-Doctoral Research, Department of Prosthodontics and Periodontology, Piracicaba Dental School, State University of Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Ana Luíza Gonçalves', 'Initials': 'ALG', 'LastName': 'Girundi', 'Affiliation': 'MSc student, Department of Prosthodontics and Periodontology, Piracicaba Dental School, State University of Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Thais Marques Simek Vega', 'Initials': 'TMSV', 'LastName': 'Gonçalves', 'Affiliation': 'Professor, Department of Odontology, Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Altair Antoninha', 'Initials': 'AA', 'LastName': 'Del Bel Cury', 'Affiliation': 'Professor, Department of Prosthodontics and Periodontology, Piracicaba Dental School, State University of Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Wander José', 'Initials': 'WJ', 'LastName': 'da Silva', 'Affiliation': 'Professor, Department of Prosthodontics and Periodontology, Piracicaba Dental School, State University of Campinas, Piracicaba, São Paulo, Brazil. Electronic address: wanderjose@unicamp.br.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2021.08.024']
2532,34756606,Effect of anodized titanium abutment collars on peri-implant soft tissue: A split-mouth clinical study.,"STATEMENT OF PROBLEM


Anodic oxidation of titanium implant abutment collars has been used to mask their unesthetic grayish color. However, the effect of anodic oxidation on the health and appearance of peri-implant soft tissues is unclear.
PURPOSE


The purpose of this split-mouth clinical study was to investigate the effect of anodized titanium on the health and esthetics of peri-implant soft tissues.
MATERIAL AND METHODS


A total of 60 osseointegrated implants placed in 30 participants were included in the present study. Each participant received 2 randomly allocated abutments, one with a pink anodized collar and the other with an unanodized one to form 2 groups: unanodized group (control group) and anodized group (experimental group). All implants were restored with lithium disilicate restorations. Evaluations of the peri-implant soft tissues were performed at the time of definitive restoration insertion (baseline) and after 3, 6, 12, and 18 months: peri-implant probing depth, soft tissue recession, modified sulcus bleeding index, modified plaque index, and modified gingival index. The esthetics of peri-implant soft tissues were evaluated by using the modified pink esthetic score. The paired t test or Wilcoxon signed-rank test was used for comparing the 2 study groups at each point of time depending on the normality of the variables (α=.05). To compare each variable at different time points within each group separately, repeated measures ANOVA or Friedman tests were used according to the normality of the variables, followed by post hoc pairwise comparisons by using the Bonferroni adjusted significance (α=.05).
RESULTS


Five peri-implant soft tissue indices were followed up throughout the study. No statistically significant differences were found among the mean values of the tested indices in the anodized and unanodized groups throughout the evaluation periods (P>.05). The collective mean values of the modified pink esthetic score also showed no statistically significant differences between the groups (P>.05).
CONCLUSIONS


Based on this split-mouth clinical study, pink anodized titanium abutment collars do not produce a clinically significant effect on the health or esthetics of peri-implant soft tissues.",2021,"The collective mean values of the modified pink esthetic score also showed no statistically significant differences between the groups (P>.05).
",['60 osseointegrated implants placed in 30 participants were included in the present study'],"['anodic oxidation', 'anodized titanium', 'unanodized group (control group) and anodized group (experimental group', 'pink anodized titanium abutment collars', 'lithium disilicate restorations', 'anodized titanium abutment collars']","['peri-implant soft tissue', 'collective mean values of the modified pink esthetic score']","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0290626,"The collective mean values of the modified pink esthetic score also showed no statistically significant differences between the groups (P>.05).
","[{'ForeName': 'Khaled Mohamed', 'Initials': 'KM', 'LastName': 'Farrag', 'Affiliation': 'Demonstrator of Fixed Prosthodontics, Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Mohamed Moataz', 'Initials': 'MM', 'LastName': 'Khamis', 'Affiliation': 'Professor and Chairman, Department of Prosthodontics, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. Electronic address: moataz_khamis@yahoo.com.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2021.09.019']
2533,34756997,Ultrasound-Guided Subgluteal Sciatic Nerve Block for Pain Management during Endovascular Treatment for Below-the-Knee Arterial Occlusions.,"PURPOSE


To evaluate the pain control of subgluteal sciatic nerve block (SSNB) in the endovascular treatment of below-the-knee (BTK) occlusions.
MATERIALS AND METHODS


This randomized prospective controlled study evaluated 60 consecutive adult patients who underwent endovascular treatment for BTK occlusions. The patients were randomized into two equal groups: the SSNB group underwent SSNB in the subgluteal space under ultrasound guidance, while the control group received fentanyl as an analgesic. The visual analog scale (VAS) and Face, Legs, Activity, Cry, Consolability (FLACC) scale scores were recorded.
RESULTS


Compared with the control group, the SSNB group showed significantly lower median VAS score (0 [range 0-30] vs 70 [range 20-100], p<0.001) and median FLACC score (0 [range 0-2] vs 6 [range 3-10], p<0.001). There was no statistical difference between the two groups regarding remaining parameters. There was a very strong correlation between the VAS and FLACC scores in both the SSNB group (r=0.805, p<0.001) and the control group (r=0.950, p<0.001). Operation time and total balloon inflation time were correlated with the VAS (r=0.411, p=0.024 and r=0.402, p=0.031, respectively) and FLACC (r=0.431, p=0.017 and r=0.414, p=0.022, respectively) scores in the control group, but not in the SSNB group (r=0. 364, p=0.056 and r=0.300, p=0.085, respectively, for correlation with VAS score and r=0.730, p=0.068 and r=0.704, p=0.075, respectively, for correlation with the FLACC score).
CONCLUSION


SSNB is a highly effective and safe pain management modality in the endovascular treatment of BTK occlusions.",2021,There was no statistical difference between the two groups regarding remaining parameters.,['60 consecutive adult patients who underwent endovascular treatment for BTK occlusions'],"['Ultrasound-Guided Subgluteal Sciatic Nerve Block', 'fentanyl as an analgesic', 'SSNB group underwent SSNB', 'SSNB', 'subgluteal sciatic nerve block (SSNB']","['median VAS score', 'FLACC', 'VAS and FLACC scores', 'VAS score', 'visual analog scale (VAS) and Face, Legs, Activity, Cry, Consolability (FLACC) scale scores', 'Operation time and total balloon inflation time', 'median FLACC score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0230037', 'cui_str': 'Structure of center of face'}]",60.0,0.0220769,There was no statistical difference between the two groups regarding remaining parameters.,"[{'ForeName': 'Gurkan', 'Initials': 'G', 'LastName': 'Danisan', 'Affiliation': 'Sakarya University Faculty of Medicine, Department of Radiology, Sakarya, TURKEY. Electronic address: gurkandanisan@yahoo.com.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Taydas', 'Affiliation': 'Sakarya University Faculty of Medicine, Department of Radiology, Sakarya, TURKEY.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2021.10.018']
2534,34756937,Exposure to models' positive facial expressions whilst eating a raw vegetable increases children's acceptance and consumption of the modelled vegetable.,"Research has shown that seeing positive facial expressions (FEs) towards food increased children's desire to eat foods rated as disliked. However, the effect of adults' positive FEs whilst eating a raw vegetable on children's acceptance and intake of nutritious foods that are less preferred (e.g., vegetables) remains to be established. This study aimed to examine the effect of models' FEs eating raw broccoli on children's acceptance and intake of raw broccoli. 111 children aged 4-6 years (64 male, 47 female) were randomised to watch a video of unfamiliar adult models eating raw broccoli with a positive or neutral facial expression (FE), or a non-food control video. Children's acceptance and intake of raw broccoli was assessed. Data about parent and child characteristics was provided by parents. There was a main effect of FE type on children's frequency of tastes (p = .03) and intake of broccoli (p = .02). Children who were exposed to models eating broccoli with positive FEs had greater frequency of tastes (p = .04) and intake of broccoli (p = .03), than children in the control condition, but not compared to children in the neutral FE condition (p > .05). There was no effect of positive FEs on children's willingness to try broccoli (p > .05). These findings suggest that observing others enjoy a commonly disliked vegetable can encourage children's tastes and intake of the vegetable. Thus, exposing children to others enjoying vegetables could be a useful strategy for encouraging healthier eating in children. Further work is needed to determine whether a single exposure is sufficient and whether these effects are sustained over time.",2021,There was no effect of positive FEs on children's willingness to try broccoli (p > .05).,"['111 children aged 4-6 years (64 male, 47 female', ""children's acceptance and intake of raw broccoli""]","[""models' FEs eating raw broccoli"", 'video of unfamiliar adult models eating raw broccoli with a positive or neutral facial expression, or a non-food control video']","[""Children's acceptance and intake of raw broccoli"", 'intake of broccoli', 'frequency of tastes']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0330498', 'cui_str': 'Brassica oleracea'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0330498', 'cui_str': 'Brassica oleracea'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0330498', 'cui_str': 'Brassica oleracea'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}]",111.0,0.0461939,There was no effect of positive FEs on children's willingness to try broccoli (p > .05).,"[{'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Edwards', 'Affiliation': 'School of Psychology, Aston University, Birmingham, UK. Electronic address: edwardk2@aston.ac.uk.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Thomas', 'Affiliation': 'School of Psychology, Aston University, Birmingham, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Higgs', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Blissett', 'Affiliation': 'School of Psychology, Aston University, Birmingham, UK.'}]",Appetite,['10.1016/j.appet.2021.105779']
2535,34756882,Outcomes According to ALK Status Determined by Central IHC or FISH in Patients with ALK-Positive NSCLC Enrolled in the Phase III ALEX Study.,"INTRODUCTION


We retrospectively examined progression-free survival (PFS) and response by ALK fluorescence in-situ hybridization (FISH) status in patients with advanced ALK immunohistochemistry (IHC)-positive non-small-cell lung cancer (NSCLC) in the ALEX study.
METHODS


303 treatment-naïve patients were randomized to receive twice-daily alectinib 600 mg or crizotinib 250 mg. ALK status was assessed centrally using Ventana ALK (D5F3) CDx IHC and Vysis ALK Break Apart FISH Probe Kit. Primary endpoint: investigator-assessed PFS. Secondary endpoints of interest: objective response rate (ORR) and duration.
RESULTS


Investigator-assessed PFS was significantly prolonged with alectinib versus crizotinib in ALK IHC-positive/FISH-positive tumors (n = 203, 67%) (HR 0.37, 95% CI: 0.25-0.56) and ALK IHC-positive/FISH-uninformative tumors (n = 61, 20%) (HR 0.39, 95% CI: 0.20-0.78), but not ALK IHC-positive/FISH-negative tumors (n = 39, 13%) (HR 1.33, 95% CI: 0.6-3.2). ORRs were higher with alectinib versus crizotinib in ALK IHC-positive/FISH-positive tumors 90.6% versus 81.4%; stratified odds ratio [OR] 2.22, 95% CI: 0.97-5.07) and ALK IHC-positive/FISH-uninformative tumors (96.0% versus 75.0%; OR 9.29, 95% CI: 1.05-81.88), but not ALK IHC-positive/FISH-negative tumors (28.6% versus 44.4%; OR 0.45, 95% CI: 0.12-1.74). Next-generation sequencing (NGS) was performed in 35/39 patients with ALK IHC-positive/FISH-negative tumors; no ALK fusion was identified in 20/35 (57.1%) patients by NGS, but 10/20 (50.0%) had partial response/stable disease.
CONCLUSION


Outcomes of patients with ALK IHC-positive/FISH-positive and ALK IHC-positive/FISH-uninformative NSCLC were similar to the overall ALEX population. These results suggest that Ventana ALK IHC is a standard testing method for selecting patients for treatment with alectinib.",2020,"ORRs were higher with alectinib versus crizotinib in ALK IHC-positive/FISH-positive tumors 90.6% versus 81.4%; stratified odds ratio [OR] 2.22, 95% CI: 0.97-5.07) and ALK IHC-positive/FISH-uninformative tumors (96.0% versus 75.0%; OR","['patients with advanced ALK immunohistochemistry (IHC)-positive non-small-cell lung cancer (NSCLC) in the ALEX study', 'patients with ALK IHC-positive/FISH-positive and ALK IHC-positive/FISH-uninformative NSCLC', '303 treatment-naïve patients', 'n = 61, 20']","['ALK fluorescence', 'twice-daily alectinib 600 mg or crizotinib 250 mg', 'Ventana ALK IHC']","['ALK fusion', 'PFS', 'interest: objective response rate (ORR) and duration', 'partial response/stable disease', 'not ALK IHC-positive/FISH-negative tumors', 'ORRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0162789', 'cui_str': 'Fluorescence in situ hybridization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3853921', 'cui_str': 'alectinib'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3204577', 'cui_str': 'crizotinib 250 MG'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}]","[{'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0162789', 'cui_str': 'Fluorescence in situ hybridization'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",,0.219211,"ORRs were higher with alectinib versus crizotinib in ALK IHC-positive/FISH-positive tumors 90.6% versus 81.4%; stratified odds ratio [OR] 2.22, 95% CI: 0.97-5.07) and ALK IHC-positive/FISH-uninformative tumors (96.0% versus 75.0%; OR","[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mok', 'Affiliation': 'State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong. Electronic address: tony@clo.cuhk.edu.hk.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado, Denver, Colorado.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Noé', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Shirish', 'Initials': 'S', 'LastName': 'Gadgeel', 'Affiliation': 'Department of Internal Medicine, Division of Hematology and Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Sai-Hong', 'Initials': 'SH', 'LastName': 'Ignatius Ou', 'Affiliation': 'University of California, Irvine School of Medicine, Orange, California.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Konopa', 'Affiliation': 'Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Pozzi', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Isabell R', 'Initials': 'IR', 'LastName': 'Loftin', 'Affiliation': 'Ventana Medical Systems Inc, Tucson, Arizona.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Ventana Medical Systems Inc, Tucson, Arizona.'}, {'ForeName': 'Alice T', 'Initials': 'AT', 'LastName': 'Shaw', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.10.007']
2536,34756796,The impact of a hand therapy workplace-based educational approach on the management of lateral elbow tendinopathy: A randomized controlled study.,"BACKGROUND


Lateral elbow tendinopathy (LET) is one of the most prevalent work-related musculoskeletal conditions. Management strategies for LET rarely consider patients' work environments and have limited focus on education regarding occupational risk factors. Workplace-based rehabilitation has shown benefits in the return to work processes for injured workers with other health conditions, but no studies have investigated the impact of a workplace-based educational approach in the management of LET.
PURPOSES


First, to identify the impact of an additional workplace-based educational intervention to standard hand therapy care on the outcomes of pain, grip strength, and function. Second, to identify the effectiveness of standard hand therapy on the same clinical outcomes.
STUDY DESIGN


A randomized controlled trial.
METHODS


Forty-nine participants were randomized to the control group (n = 25) or intervention group (n == 24). The control group received standard hand therapy for 12 weeks. The intervention group received standard hand therapy for the first 12 weeks plus an additional workplace-based educational intervention, ""Working Hands-ED,"" delivered by a hand therapist. Pain levels for provocative tests, grip strength, and function were measured using a Numeric Rating Scale, Jamar Dynamometer, and the Patient-Rated Tennis Elbow Evaluation questionnaire at baseline, weeks 6 and 12. The Patient-Specific Functional Scale was also used for the intervention group.
RESULTS


There were no statistical differences between both groups for all clinical outcomes by 12 weeks (P> .05). Pain levels for all provocative tests and Patient-Rated Tennis Elbow Evaluation scores statistically improved within both groups (P < .05), however with small effect sizes observed. The Patient-Specific Functional Scale scores statistically improved for the intervention group by 12 weeks (P < .05).
CONCLUSION


The addition of a hand therapy workplace-based intervention did not result in superior clinical outcomes for pain, grip strength, and function. The study identified that a multimodal self-management approach used by hand therapists improved their patients' pain and function regardless of whether the education was given in the clinic or the workplace.",2021,"Pain levels for all provocative tests and Patient-Rated Tennis Elbow Evaluation scores statistically improved within both groups (P < .05), however with small effect sizes observed.","['lateral elbow tendinopathy', 'injured workers with other health conditions', 'Forty-nine participants']","['hand therapy workplace-based educational approach', 'standard hand therapy for the first 12 weeks plus an additional workplace-based educational intervention, ""Working Hands-ED,"" delivered by a hand therapist', 'standard hand therapy', 'Workplace-based rehabilitation', 'additional workplace-based educational intervention to standard hand therapy care']","['Patient-Specific Functional Scale scores', 'Pain levels for provocative tests, grip strength, and function', 'Pain levels', 'Numeric Rating Scale, Jamar Dynamometer, and the Patient-Rated Tennis Elbow Evaluation questionnaire', 'Patient-Rated Tennis Elbow Evaluation scores', 'pain, grip strength, and function']","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C4277745', 'cui_str': 'Elbow Tendinopathy'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0729315', 'cui_str': 'Hand therapy'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C4304945', 'cui_str': 'Patient-Specific Functional Scale score'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0201784', 'cui_str': 'Provocative test'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",49.0,0.0125073,"Pain levels for all provocative tests and Patient-Rated Tennis Elbow Evaluation scores statistically improved within both groups (P < .05), however with small effect sizes observed.","[{'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': 'Curtin School of Allied Health, Curtin University, Perth, Western Australia, Australia. Electronic address: thuy.tran23@hotmail.com.'}, {'ForeName': 'Courtenay', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'Curtin School of Allied Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Ciccarelli', 'Affiliation': 'Curtin School of Allied Health, Curtin University, Perth, Western Australia, Australia.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2021.09.004']
2537,34756786,Long-term evaluation of maxillary molar position after distalization using modified C-palatal plates in patients with and without second molar eruption.,"INTRODUCTION


The purpose of this study was to analyze the treatment effects after molar distalization using modified C-palatal plates with and without second molar eruption and, to evaluate the three-dimensional position of the molars during long-term retention using cone-beam computed tomography.
METHODS


The study sample comprised 74 third molars in 42 patients. Twenty-seven adolescent patients (mean age, 12.6 years) having 48 maxillary third molars were divided into 2 groups according to the eruption of their second molars: 15 patients with second molar eruption (group 1) and 12 patients without second molar eruption (group 2). Pretreatment, posttreatment, and long-term data (mean, 5.2 years) from cone-beam computed tomography were scanned and compared with control groups.
RESULTS


There was less tipping movement of the first and second molars (0.94° and 3.22°) and distal tipping movement of the third molars (8.91°) in group 1 than in group 2 (4.36°, 7.39°, and 3.08°, respectively), but the treatment time was shorter and the positional change of the third molars was insignificant in group 2. In the long-term, the second molars fully erupted after distalization in group 2, and there was no difference in the third molar position between group 1, group 2, and the control group, except for the vertical position of the third molars in group 1.
CONCLUSIONS


In the long-term, the second molars fully erupted after distalization, and the third molars were in a favorable position. Therefore, these findings suggest that clinicians do not need to extract developing third molars before distalization in adolescents.",2021,"There was less tipping movement of the first and second molars (0.94° and 3.22°) and distal tipping movement of the third molars (8.91°) in group 1 than in group 2 (4.36°, 7.39°, and 3.08°, respectively), but the treatment time was shorter and the positional change of the third molars was insignificant in group 2.","['74 third molars in 42 patients', 'patients with and without second\xa0molar eruption', 'Twenty-seven adolescent patients (mean age, 12.6\xa0years) having 48 maxillary third molars were divided into 2 groups according to the eruption of their second\xa0molars: 15 patients with second\xa0molar eruption (group 1) and 12 patients without second\xa0molar eruption (group 2']","['molar distalization using modified C-palatal plates with and without second\xa0molar eruption', 'modified C-palatal plates']","['tipping movement', 'distal tipping movement']","[{'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]","[{'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205108', 'cui_str': 'Distal'}]",27.0,0.0262558,"There was less tipping movement of the first and second molars (0.94° and 3.22°) and distal tipping movement of the third molars (8.91°) in group 1 than in group 2 (4.36°, 7.39°, and 3.08°, respectively), but the treatment time was shorter and the positional change of the third molars was insignificant in group 2.","[{'ForeName': 'Jou Hee', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ""Department of Orthodontics, Seoul St. Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Yoonji', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': ""Department of Orthodontics, Seoul St. Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Jae Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Postgraduate Orthodontic Program, Arizona School of Dentistry & Oral Health, A.T. Still University, Mesa, Ariz, and Graduate School of Dentistry, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Nam-Ki', 'Initials': 'NK', 'LastName': 'Lee', 'Affiliation': 'Department of Orthodontics, Section of Dentistry, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Seong-Hun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Orthodontics, Graduate School, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Yoon-Ah', 'Initials': 'YA', 'LastName': 'Kook', 'Affiliation': ""Department of Orthodontics, Seoul St. Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, Korea. Electronic address: kook2002@catholic.ac.kr.""}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.06.052']
2538,34757221,Developing a virtual assessment protocol for the AMPLIFI Randomized Controlled Trial due to COVID-19: From assessing participants' preference to preparing the team.,"Background During the COVID-19 pandemic, in-person research assessments needed to be adapted to ensure safety of participants and staff. Participants' willingness to participate in research activities, how to prepare assessors to ensure data integrity, and the feasibility of modified protocols, were unknown. Within the AMPLIFI randomized clinical trial (RCT) for cancer survivors, we elicited participants' preferences and willingness to participate in Clinic, Home, or Virtual assessments, prepared assessors for, and implemented virtual assessments. Methods 1) We conducted phone surveys of potential AMPLIFI participants; 2) Based on survey results, we modified assessments from in-person to virtual visits (VV) by videoconference. Assessors were trained and certified, i.e., assessors recorded 3 assessments that were reviewed and scored by 2 investigators. The modified protocol was proposed to 62 participants: we report numbers of those who agreed to attend VV. Results 1) Survey results: Among 74 survey respondents, 44.6% preferred, 75.7% were willing to attend Clinic Visits; 32.4% preferred, 83.8% were willing to do VV; 23% preferred, 77% were willing to do Home Visits. Survivors 70+ were less likely than 50-69 years old to be willing to do VV: no other differences were noted by gender, race, rural status or education. 2) Assessment uptake: 66.1% agreed to attend VV, and of them 75.6% completed them. Conclusion Diverse research participants adapted to protocols that prioritize their safety, although older participants may be reluctant to do virtual assessments. Virtual assessments are feasible and research teams can rigorously prepare to collect quality data through them.",2021,"Survivors 70+ were less likely than 50-69 years old to be willing to do VV: no other differences were noted by gender, race, rural status or education.","['62 participants: we report numbers of those who agreed to attend VV', 'potential AMPLIFI participants']",['videoconference'],[],"[{'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}]",[],77.0,0.346304,"Survivors 70+ were less likely than 50-69 years old to be willing to do VV: no other differences were noted by gender, race, rural status or education.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pisu', 'Affiliation': ""Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: mpisu@uab.edu.""}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Omairi', 'Affiliation': 'Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Hoenemeyer', 'Affiliation': ""O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA; School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Karina I', 'Initials': 'KI', 'LastName': 'Halilova', 'Affiliation': 'Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Yu-Mei M', 'Initials': 'YM', 'LastName': 'Schoenberger', 'Affiliation': ""Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Laura Q', 'Initials': 'LQ', 'LastName': 'Rogers', 'Affiliation': ""Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Kenzik', 'Affiliation': ""O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA; Division of Hematology & Oncology, University of Alabama at Birmingham, Birmingham, AL, USA; Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Oster', 'Affiliation': ""Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Nataliya V', 'Initials': 'NV', 'LastName': 'Ivankova', 'Affiliation': 'School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Dori', 'Initials': 'D', 'LastName': 'Pekmezi', 'Affiliation': ""O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA; Department of Health Behavior, School of Public Health, University of Alabama at Birmingham, AL, USA.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fontaine', 'Affiliation': ""O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA; Department of Health Behavior, School of Public Health, University of Alabama at Birmingham, AL, USA.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': ""O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA; School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Michelle Y', 'Initials': 'MY', 'LastName': 'Martin', 'Affiliation': 'Center for Innovation in Health Equity Research, Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106604']
2539,34757148,Aesthetic outcome of simple cuticular suture distance from the wound edge on the closure of linear wounds on the head and neck: a randomized evaluator blinded split wound comparative effect trial.,"BACKGROUND


Little data supports the optimal distance of cuticular suture placement from the wound edge to achieve the most cosmetically appealing scar.
OBJECTIVE


To compare POSAS scores for cutaneous sutures spaced 2 versus 5 mm from the wound edge in head and neck defects repaired via linear closure.
METHODS


Fifty patients were enrolled in this randomized, evaluator blinded, split-scar study. Surgical wounds were repaired with cuticular sutures 2 mm from the wound edge on one side and 5 mm on the other side. POSAS scores and scar width was compared three-months post-operatively.
RESULTS


This study in sum observer POSAS score, with a mean (SD) of 16.06 (6.49) on the 2-mm side and 15.82 (6.83) on the 5-mm side (p=0.807). Similarly, no difference was seen in scar width, with a mean (SD) of 0.100 (0.058) cm on the 2-mm side and 0.100 (0.076) cm on the 5-mm side (p=0.967).
LIMITATIONS


Linear repairs were studied on head and neck defects after extirpation of cutaneous malignancies, resulting in a homogeneous elderly white patient population.
CONCLUSION


Cuticular sutures placed 2 or 5 mm from the wound edge did not result in different cosmetic outcomes in linear closures on the head and neck.",2021,"CONCLUSION


Cuticular sutures placed 2 or 5 mm from the wound edge did not result in different cosmetic outcomes in linear closures on the head and neck.","['linear wounds on the head and neck', 'Fifty patients', 'homogeneous elderly white patient population']",['simple cuticular suture distance'],"['POSAS scores and scar width', 'scar width', 'POSAS scores']","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0487742', 'cui_str': 'Width'}]",50.0,0.0753963,"CONCLUSION


Cuticular sutures placed 2 or 5 mm from the wound edge did not result in different cosmetic outcomes in linear closures on the head and neck.","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Weinkle', 'Affiliation': 'University of California, Davis, Department of Dermatology, 3301 C Street Suite 1300, Sacramento, CA 95816. Electronic address: allisonweinkle@gmail.com.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Harrington', 'Affiliation': 'University of California, Davis, Department of Dermatology, 3301 C Street Suite 1300, Sacramento, CA 95816.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Kang', 'Affiliation': 'University of California, Davis, Department of Dermatology, 3301 C Street Suite 1300, Sacramento, CA 95816.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Keck School of Medicine at University of Southern California, Los Angeles, Department of Dermatology, HC4 2000 1450 San Pablo Health Sciences Campus, Los Angeles, CA, 90089.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Eisen', 'Affiliation': 'University of California, Davis, Department of Dermatology, 3301 C Street Suite 1300, Sacramento, CA 95816.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2021.10.036']
2540,34757134,A FOUR PROBIOTIC PREPARATION FOR VENTILATOR-ASSOCIATED PNEUMONIA IN MULTI-TRAUMA PATIENTS: RESULTS OF A RANDOMIZED CLINICAL TRIAL.,"The role of probiotics for the prevention of ventilator-associated pneumonia remains inconclusive. Our aim was to assess the efficacy of a probiotics regimen for VAP prophylaxis in mechanically ventilated multi-trauma patients, intubated immediately after the injurious insult. In a randomized, placebo-controlled study enrolling multi-trauma patients, anticipated to require mechanical ventilation for more than 10 days were randomly assigned to receive prophylaxis either with a probiotic formula [n=59] or placebo [n=53]. The probiotic formula was a preparation of Lactobacillus acidophilus LA-5 (1.75 × 10 9  cfu), L. plantarum (0.5 × 10 9  cfu), B. lactis BB-12 (1.75 × 10 9  cfu) and S. boulardii (1.5 × 10 9  cfu) per sachet. Each patient received two sachets twice daily for 15 days; one through the nasogastric tube; and another spread on the oropharynx. The incidence of VAP was the primary endpoint. The incidence of other infections and sepsis and the duration of hospital stay were the secondary endpoints. Probiotics administration reduced notably the incidence of VAP [11.9% vs 28.3%, odds ratio 0.34, 95%CIs 0.13-0.92, p=0.034] and of sepsis [6.8% vs 24.5%, OR 0.22, 95% CIs 0.07-0.74, p=0.016]. Furthermore, probiotics prophylaxis decreases the time of stay in the intensive care unit (ICU) and of hospital stay. The prophylactic use of probiotics as a combination of enteral and topical application to oropharynx exerted a positive effect on the incidence of VAP and sepsis as well as on the ICU and total hospital stay in patients under protracted mechanical ventilation.",2021,"Probiotics administration reduced notably the incidence of VAP [11.9% vs 28.3%, odds ratio 0.34, 95%CIs 0.13-0.92, p=0.034] and of sepsis [6.8% vs 24.5%, OR 0.22, 95% CIs 0.07-0.74, p=0.016].","['patients under protracted mechanical ventilation', 'controlled study enrolling multi-trauma patients, anticipated to require mechanical ventilation for more than 10 days', 'mechanically ventilated multi-trauma patients, intubated immediately after the injurious insult']","['Probiotics', 'probiotics regimen', 'prophylaxis either with a probiotic formula [n=59] or placebo', 'placebo', 'boulardii']","['sepsis', 'incidence of VAP', 'time of stay in the intensive care unit (ICU) and of hospital stay', 'incidence of other infections and sepsis and the duration of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.195533,"Probiotics administration reduced notably the incidence of VAP [11.9% vs 28.3%, odds ratio 0.34, 95%CIs 0.13-0.92, p=0.034] and of sepsis [6.8% vs 24.5%, OR 0.22, 95% CIs 0.07-0.74, p=0.016].","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsilika', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Giannoula', 'Initials': 'G', 'LastName': 'Thoma', 'Affiliation': 'Intensive Care Unit, AHEPA General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Zoi', 'Initials': 'Z', 'LastName': 'Aidoni', 'Affiliation': 'Intensive Care Unit, AHEPA General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Tsaousi', 'Affiliation': 'Intensive Care Unit, AHEPA General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Kyriakos', 'Initials': 'K', 'LastName': 'Fotiadis', 'Affiliation': 'Intensive Care Unit, AHEPA General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Stavrou', 'Affiliation': 'Department of Surgery, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Malliou', 'Affiliation': 'Department of Surgery, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Chorti', 'Affiliation': 'Department of Surgery, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Massa', 'Affiliation': 'Intensive Care Unit, Ippokrateion General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Antypa', 'Affiliation': 'Intensive Care Unit, Georgios Gennimatas General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Vasiliadou', 'Affiliation': 'Intensive Care Unit, George Papanikolaou General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Pagdatoglou', 'Affiliation': 'Intensive Care Unit, Trikala General Hospital, Trikala, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Voudouris', 'Affiliation': 'Intensive Care Unit, Aghios Pavlos General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Spyridoula', 'Initials': 'S', 'LastName': 'Vasiliagou', 'Affiliation': 'Department of Surgery, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Giakoumis', 'Initials': 'G', 'LastName': 'Mitos', 'Affiliation': 'Intensive Care Unit, AHEPA General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Ntina', 'Initials': 'N', 'LastName': 'Kontopoulou', 'Affiliation': 'Intensive Care Unit, Georgios Gennimatas General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Paraforou', 'Affiliation': 'Intensive Care Unit, Trikala General Hospital, Trikala, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Antoniadou', 'Affiliation': 'Intensive Care Unit, Georgios Gennimatas General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mouloudi', 'Affiliation': 'Intensive Care Unit, Ippokrateion General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Gkeka', 'Affiliation': 'Intensive Care Unit, AHEPA General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Vasilis', 'Initials': 'V', 'LastName': 'Grosomanidis', 'Affiliation': 'Intensive Care Unit, AHEPA General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Evangelos J', 'Initials': 'EJ', 'LastName': 'Giamarellos-Bourboulis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece. Electronic address: egiamarel@med.uoa.gr.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Kotzampassi', 'Affiliation': 'Department of Surgery, Aristotle University of Thessaloniki, Greece.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2021.106471']
2541,34757489,"Patient-reported outcomes during repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy for isolated unresectable colorectal peritoneal metastases in a multicenter, single-arm, phase 2 trial (CRC-PIPAC).","BACKGROUND


CRC-PIPAC prospectively assessed repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-OX) as a palliative monotherapy (i.e., without concomitant systemic therapy in between subsequent procedures) for unresectable colorectal peritoneal metastases (CPM). The present study explored patient-reported outcomes (PROs) during trial treatment.
METHODS


In this single-arm phase 2 trial in two tertiary centers, patients with isolated unresectable CPM received 6-weekly PIPAC-OX (92 mg/m 2 ). PROs (calculated from EQ-5D-5L, and EORTC QLQ-C30 and QLQ-CR29) were compared between baseline and 1 and 4 weeks after the first three procedures using linear mixed modeling with determination of clinical relevance (Cohen's D ≥ 0.50) of statistically significant differences.
RESULTS


Twenty patients underwent 59 procedures (median 3 [range 1-6]). Several PROs solely worsened 1 week after the first procedure (index value - 0.10, p < 0.001; physical functioning - 20, p < 0.001; role functioning - 27, p < 0.001; social functioning - 18, p < 0.001; C30 summary score - 16, p < 0.001; appetite loss + 15, p = 0.007; diarrhea + 15, p = 0.002; urinary frequency + 13, p = 0.004; flatulence + 13, p = 0.001). These PROs returned to baseline at subsequent time points. Other PROs worsened 1 week after the first procedure (fatigue + 23, p < 0.001; pain + 29, p < 0.001; abdominal pain + 32, p < 0.001), second procedure (fatigue + 20, p < 0.001; pain + 21, p < 0.001; abdominal pain + 20, p = 0.002), and third procedure (pain + 22, p < 0.001; abdominal pain + 22, p = 0.002). Except for appetite loss, all changes were clinically relevant. All analyzed PROs returned to baseline 4 weeks after the third procedure.
CONCLUSIONS


Patients receiving repetitive PIPAC-OX monotherapy for unresectable CPM had clinically relevant but reversible worsening of several PROs, mainly 1 week after the first procedure.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT03246321; Netherlands trial register: NL6426.",2021,"Other PROs worsened 1 week after the first procedure (fatigue + 23, p < 0.001; pain + 29, p < 0.001; abdominal pain + 32, p < 0.001), second procedure (fatigue + 20, p < 0.001; pain + 21, p < 0.001; abdominal pain + 20, p = 0.002), and third procedure (pain + 22, p < 0.001; abdominal pain + 22, p = 0.002).","['Twenty patients underwent 59 procedures (median 3 [range 1-6', 'unresectable colorectal peritoneal metastases (CPM']","['repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-OX', 'PIPAC-OX', 'repetitive PIPAC-OX monotherapy', 'repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy']","['appetite loss', 'abdominal pain', 'PROs (calculated from EQ-5D-5L, and EORTC QLQ-C30 and QLQ-CR29']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant neoplasm of peritoneum'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",20.0,0.368733,"Other PROs worsened 1 week after the first procedure (fatigue + 23, p < 0.001; pain + 29, p < 0.001; abdominal pain + 32, p < 0.001), second procedure (fatigue + 20, p < 0.001; pain + 21, p < 0.001; abdominal pain + 20, p = 0.002), and third procedure (pain + 22, p < 0.001; abdominal pain + 22, p = 0.002).","[{'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Lurvink', 'Affiliation': 'Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.'}, {'ForeName': 'Koen P', 'Initials': 'KP', 'LastName': 'Rovers', 'Affiliation': 'Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.'}, {'ForeName': 'Emma C E', 'Initials': 'ECE', 'LastName': 'Wassenaar', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, The Netherlands.'}, {'ForeName': 'Checca', 'Initials': 'C', 'LastName': 'Bakkers', 'Affiliation': 'Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.'}, {'ForeName': 'Jacobus W A', 'Initials': 'JWA', 'LastName': 'Burger', 'Affiliation': 'Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.'}, {'ForeName': 'Geert-Jan M', 'Initials': 'GM', 'LastName': 'Creemers', 'Affiliation': 'Department of Medical Oncology, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.'}, {'ForeName': 'Maartje', 'Initials': 'M', 'LastName': 'Los', 'Affiliation': 'Department of Medical Oncology, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, The Netherlands.'}, {'ForeName': 'Floortje', 'Initials': 'F', 'LastName': 'Mols', 'Affiliation': 'Department of Research and Development, Netherlands Comprehensive Cancer Organization, Utrecht, The Netherlands.'}, {'ForeName': 'Marinus J', 'Initials': 'MJ', 'LastName': 'Wiezer', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, The Netherlands.'}, {'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Nienhuijs', 'Affiliation': 'Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.'}, {'ForeName': 'Djamila', 'Initials': 'D', 'LastName': 'Boerma', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, The Netherlands.'}, {'ForeName': 'Ignace H J T', 'Initials': 'IHJT', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands. ignace.d.hingh@catharinaziekenhuis.nl.'}]",Surgical endoscopy,['10.1007/s00464-021-08802-6']
2542,34757487,Weight changes in heart failure with preserved ejection fraction: findings from TOPCAT.,"BACKGROUND


Weight loss has been associated with poor outcomes in patients with heart failure (HF). However, few data are available for patients with heart failure with preserved ejection fraction (HFpEF). The impact of weight gain on outcomes has not been frequently reported either.
AIMS


To study post-randomization weight changes and how these could impact outcomes and the effect of spironolactone in patients with HFpEF enrolled in the TOPCAT-Americas trial (N = 1767).
METHODS


Mixed-effects regressions and time-updated Cox models to assess the factors associated with weight changes and their impact on subsequent outcomes.
RESULTS


Over a median follow-up of 3 years, 824 (47%) patients experienced weight loss ≥ 5% and 390 (22%) experienced weight loss ≥ 10%. Patients experiencing weight loss were older and more frequently women with severe HF symptoms. Spironolactone slightly reduced body weight before 12 months of follow-up: β =  - 0.55 (- 0.82 to - 0.29) kg, without effect on weight afterwards: β = 0.01 (- 0.66 to 0.68) kg; treatment-by-time interaction P = 0.0015. Spironolactone did not increase the odds of weight loss but reduced the odds of weight gain. Weight loss ≥ 5% was associated with a higher risk of cardiovascular and all-cause death irrespective of baseline body mass index: HR = 1.47, 95%CI = 1.07-2.01 and HR = 1.84, 95%CI = 1.46-2.31, respectively. Weight gain was not associated with an increased risk of any outcome.
CONCLUSION


Weight loss ≥ 5% was frequent and independently associated with an increased risk of subsequent mortality. Spironolactone induced only slight body weight reductions early after its introduction and up to a maximum of 8-12 months of follow-up. Association between body weight changes and subsequent death. Legend: HR, hazard ratio from time-updated Cox models. Model adjusted on age, sex, race, NYHA class, systolic blood pressure, diabetes, atrial fibrillation, previous myocardial infarction, previous heart failure hospitalization, estimated glomerular filtration rate, diuretic use, and baseline weight.",2021,"Weight loss ≥ 5% was associated with a higher risk of cardiovascular and all-cause death irrespective of baseline body mass index: HR = 1.47, 95%CI = 1.07-2.01 and HR = 1.84, 95%CI = 1.46-2.31, respectively.","['patients with heart failure (HF', 'patients with HFpEF enrolled in the TOPCAT-Americas trial (N\u2009=\u20091767', 'patients with heart failure with preserved ejection fraction (HFpEF']","['Spironolactone', 'spironolactone']","['risk of subsequent mortality', 'body weight', 'weight loss', 'weight gain', 'Weight gain', 'body weight changes and subsequent death', 'slight body weight reductions', 'odds of weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.066811,"Weight loss ≥ 5% was associated with a higher risk of cardiovascular and all-cause death irrespective of baseline body mass index: HR = 1.47, 95%CI = 1.07-2.01 and HR = 1.84, 95%CI = 1.46-2.31, respectively.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Centre d'Investigations Cliniques Plurithématique 1433, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Université de Lorraine, Inserm, Inserm U1116, CHRU Nancy - Hopitaux de Brabois, Institut Lorrain du Coeur Et Des Vaisseaux Louis Mathieu, 4 rue du Morvan, 54500, Vandoeuvre les Nancy, France. j.ferreira@chru-nancy.fr.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Centre d'Investigations Cliniques Plurithématique 1433, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Université de Lorraine, Inserm, Inserm U1116, CHRU Nancy - Hopitaux de Brabois, Institut Lorrain du Coeur Et Des Vaisseaux Louis Mathieu, 4 rue du Morvan, 54500, Vandoeuvre les Nancy, France.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Pfeffer', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Centre d'Investigations Cliniques Plurithématique 1433, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Université de Lorraine, Inserm, Inserm U1116, CHRU Nancy - Hopitaux de Brabois, Institut Lorrain du Coeur Et Des Vaisseaux Louis Mathieu, 4 rue du Morvan, 54500, Vandoeuvre les Nancy, France.""}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-021-01962-4']
2543,34757439,"Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial.","PURPOSE


We compared dexamethasone 12 versus 6 mg daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia in the international, randomised, blinded COVID STEROID 2 trial. In the primary, conventional analyses, the predefined statistical significance thresholds were not reached. We conducted a pre-planned Bayesian analysis to facilitate probabilistic interpretation.
METHODS


We analysed outcome data within 90 days in the intention-to-treat population (data available in 967 to 982 patients) using Bayesian models with various sensitivity analyses. Results are presented as median posterior probabilities with 95% credible intervals (CrIs) and probabilities of different effect sizes with 12 mg dexamethasone.
RESULTS


The adjusted mean difference on days alive without life support at day 28 (primary outcome) was 1.3 days (95% CrI -0.3 to 2.9; 94.2% probability of benefit). Adjusted relative risks and probabilities of benefit on serious adverse reactions was 0.85 (0.63 to 1.16; 84.1%) and on mortality 0.87 (0.73 to 1.03; 94.8%) at day 28 and 0.88 (0.75 to 1.02; 95.1%) at day 90. Probabilities of benefit on days alive without life support and days alive out of hospital at day 90 were 85 and 95.7%, respectively. Results were largely consistent across sensitivity analyses, with relatively low probabilities of clinically important harm with 12 mg on all outcomes in all analyses.
CONCLUSION


We found high probabilities of benefit and low probabilities of clinically important harm with dexamethasone 12 mg versus 6 mg daily in patients with COVID-19 and severe hypoxaemia on all outcomes up to 90 days.",2021,Adjusted relative risks and probabilities of benefit on serious adverse reactions was 0.85 (0.63 to 1.16; 84.1%) and on mortality 0.87 (0.73 to 1.03; 94.8%) at day 28 and 0.88 (0.75 to 1.02; 95.1%) at day 90.,"['patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia in the international', 'patients with COVID-19 and severe hypoxaemia']","['Dexamethasone', 'dexamethasone']","['median posterior probabilities', 'days alive without life support', 'Adjusted relative risks and probabilities of benefit on serious adverse reactions', 'Probabilities of benefit on days alive without life support and days alive out of hospital']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.434019,Adjusted relative risks and probabilities of benefit on serious adverse reactions was 0.85 (0.63 to 1.16; 84.1%) and on mortality 0.87 (0.73 to 1.03; 94.8%) at day 28 and 0.88 (0.75 to 1.02; 95.1%) at day 90.,"[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. andersgran@gmail.com.'}, {'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Munch', 'Affiliation': 'Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Sheila Nainan', 'Initials': 'SN', 'LastName': 'Myatra', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Bharath Kumar Tirupakuzhi', 'Initials': 'BKT', 'LastName': 'Vijayaraghavan', 'Affiliation': 'Department of Critical Care, Apollo Hospitals, Chennai, India.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cronhjort', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rebecka Rubenson', 'Initials': 'RR', 'LastName': 'Wahlin', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Maj-Brit Nørregaard', 'Initials': 'MN', 'LastName': 'Kjær', 'Affiliation': 'Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Gitte Kingo', 'Initials': 'GK', 'LastName': 'Vesterlund', 'Affiliation': 'Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Tine Sylvest', 'Initials': 'TS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Helleberg', 'Affiliation': 'Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Center of Research & Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Naomi E', 'Initials': 'NE', 'LastName': 'Hammond', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Micallef', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Bassi', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Oommen', 'Initials': 'O', 'LastName': 'John', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Vivekanand', 'Initials': 'V', 'LastName': 'Jha', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Klaus Tjelle', 'Initials': 'KT', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke Lind', 'Initials': 'VL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Thoracic Anaesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Smitt', 'Affiliation': 'Department of Neuroanaesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Andreasen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Lone Musaeus', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Anne Craveiro', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Odense University Hospital, Odense C, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Møller', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Næstved-Slagelse-Ringsted Hospital, Slagelse, Denmark.'}, {'ForeName': 'Mohd Saif', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': 'Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Ranchi, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Padmanaban', 'Affiliation': 'Department of Critical Care, Apollo Hospitals, Chennai, India.'}, {'ForeName': 'Jigeeshu Vasishtha', 'Initials': 'JV', 'LastName': 'Divatia', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sanjith', 'Initials': 'S', 'LastName': 'Saseedharan', 'Affiliation': 'Department of Intensive Care, SL Raheja Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Borawake', 'Affiliation': 'Department of Intensive Care, Vishwaraj Hospital, Pune, India.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Kapadia', 'Affiliation': 'Section of Critical Care, Department of Medicine, Hinduja Hospital, Mahim, Mumbai, India.'}, {'ForeName': 'Subhal', 'Initials': 'S', 'LastName': 'Dixit', 'Affiliation': 'Department of Critical Care Medicine, Sanjeevan Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Chawla', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Indraprastha Apollo Hospital, New Delhi, India.'}, {'ForeName': 'Urvi', 'Initials': 'U', 'LastName': 'Shukla', 'Affiliation': 'Intensive Care Unit and Emergency Services, Symbiosis University Hospital and Research Centre, Lavale, Pune, India.'}, {'ForeName': 'Pravin', 'Initials': 'P', 'LastName': 'Amin', 'Affiliation': 'Department of Critical Care Medicine, Bombay Hospital Institute of Medical Sciences, Mumbai, India.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Chew', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Christian Aage', 'Initials': 'CA', 'LastName': 'Wamberg', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Centre for Clinical Intervention Research, Copenhagen Trial Unit, Capital Region of Denmark, Copenhagen University Hospital -Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}]",Intensive care medicine,['10.1007/s00134-021-06573-1']
2544,34757343,The Efficacy of Preoperative Duloxetine in Patients Undergoing Major Abdominal Cancer Surgery: A Randomized Controlled Trial.,"OBJECTIVE


We aimed to evaluate the analgesic efficacy as well as the postoperative quality of recovery of preoperative oral duloxetine a serotonin and norepinephrine reuptake inhibitor for patients undergoing major abdominal cancer surgery.
MATERIALS AND METHODS


Sixty-two patients, undergoing major abdominal cancer surgery were divided into 2 equal groups, received oral duloxetine 60 mg (2 h preoperative) or placebo. Postoperative 48 hours morphine consumption, visual analog scale pain score, and quality of recovery were measured.
RESULTS


The cumulative 48 hours morphine consumption was significantly reduced in the duloxetine group compared with the placebo group (mean±SD) (5.2±3.2 vs. 12.9±3.4 mg), mean difference (95% confidence interval) 7.6 mg (5.9-9.3) P<0.001. The time to first morphine request was delayed significantly in the duloxetine group, median (interquartile range), 25 (19 to 38) versus 8 (4 to 9) hours, P<0.001. The duloxetine group had lower pain scores than the placebo group at 8, 12, 16, and 24 hours postoperatively, however, nonsignificant changes were observed at 0, 2, 4, 36, and 48 hours postoperatively. Participants in the duloxetine group had a better postoperative quality of recovery than the placebo group. The median (interquartile range) of the global quality of recovery-40 scoring system for the duloxetine group was 185 (180 to 191) compared with 170 (163 to 175) in the placebo group (P<0.001).
DISCUSSION


A single preoperative dose of oral duloxetine, 60 mg for patients subjected to major abdominal cancer surgery reduced postoperative pain, decreased opioid consumption, and improved the quality of recovery.",2021,"The duloxetine group had lower pain scores than the placebo group at 8, 12, 16, and 24 hours postoperatively, however, nonsignificant changes were observed at 0, 2, 4, 36, and 48 hours postoperatively.","['Patients Undergoing Major Abdominal Cancer Surgery', 'Sixty-two patients, undergoing major abdominal cancer surgery', 'patients undergoing major abdominal cancer surgery']","['duloxetine', 'duloxetine a serotonin and norepinephrine reuptake inhibitor', 'oral duloxetine', 'Preoperative Duloxetine', 'oral duloxetine 60\u2009mg (2\u2009h preoperative) or placebo', 'placebo']","['postoperative quality of recovery', 'global quality of recovery-40 scoring system', 'postoperative pain, decreased opioid consumption', 'lower pain scores', 'cumulative 48 hours morphine consumption', 'time to first morphine request', 'quality of recovery', 'Postoperative 48 hours morphine consumption, visual analog scale pain score, and quality of recovery', 'analgesic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0153662', 'cui_str': 'Malignant neoplasm of abdomen'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517835', 'cui_str': '62'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C1579361', 'cui_str': 'SSRIs and NRIs'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1667738', 'cui_str': 'duloxetine 60 MG'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.854345,"The duloxetine group had lower pain scores than the placebo group at 8, 12, 16, and 24 hours postoperatively, however, nonsignificant changes were observed at 0, 2, 4, 36, and 48 hours postoperatively.","[{'ForeName': 'Diab Fuad', 'Initials': 'DF', 'LastName': 'Hetta', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut City, Egypt.'}, {'ForeName': 'Nourhan Alaa', 'Initials': 'NA', 'LastName': 'Elgalaly', 'Affiliation': ''}, {'ForeName': 'Montaser A Fattah', 'Initials': 'MAF', 'LastName': 'Mohammad', 'Affiliation': ''}]",The Clinical journal of pain,['10.1097/AJP.0000000000000983']
2545,34757341,Changes in Brain-derived Neurotrophic Factor From Active and Sham Transcranial Direct Current Stimulation in Older Adults With Knee Osteoarthritis.,"OBJECTIVES


Previous work has shown effects of transcranial direct current stimulation (tDCS) on clinical pain measures, qualitative sensory testing measures, and peripheral inflammation. The present report extends this research to investigate the effect of tDCS on brain-derived neurotrophic factor (BDNF) levels.
MATERIALS AND METHODS


This secondary analysis examined a sample of 40 older adults (50 to 70 y old) with symptomatic knee osteoarthritis randomly assigned in a 1:1 fashion to active (n=20) or sham (n=20) tDCS for 20 minutes on 5 consecutive days. BDNF was measured before the first session and after the final treatment session. Generalized linear modeling evaluated BDNF plasma levels as a function of tDCS group, adjusted for baseline. Bayesian statistical inference was used to quantify the probability that effects of the treatment exist.
RESULTS


Generalized linear modeling indicated a 90.4% posterior probability that the sham condition had 49.9% higher BDNF at the end of treatment, controlling for baseline. Follow-up analyses within the active TDCS group supported an association between change in BDNF and change in clinical pain, and exploratory analyses found an effect of tDCS on irisin.
DISCUSSION


Results indicated that tDCS could be a potential nonpharmacological treatment to decrease BDNF levels, which may in turn decrease pain. This study adds to a growing literature suggesting that tDCS affects cortical excitability, and consequentially, the neural circuits implicated in pain modulation. In addition to a direct connection to analgesia, BDNF changes may reflect tDCS-induced changes in different cortical areas and/or neural circuits.",2021,"Follow-up analyses within the active TDCS group supported an association between change in BDNF and change in clinical pain, and exploratory analyses found an effect of tDCS on irisin.
","['Older Adults With Knee Osteoarthritis', '40 older adults (50 to 70\u2009y old) with symptomatic knee osteoarthritis randomly assigned in a 1:1 fashion to active (n=20) or sham (n=20']","['transcranial direct current stimulation (tDCS', 'tDCS', 'Neurotrophic Factor From Active and Sham Transcranial Direct Current Stimulation']","['BDNF plasma levels', 'brain-derived neurotrophic factor (BDNF) levels', 'BDNF', 'BDNF levels', 'clinical pain measures, qualitative sensory testing measures, and peripheral inflammation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",40.0,0.0500688,"Follow-up analyses within the active TDCS group supported an association between change in BDNF and change in clinical pain, and exploratory analyses found an effect of tDCS on irisin.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Suchting', 'Affiliation': 'UTHealth McGovern Medical School, Faillace Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Antonio L', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'UTHealth McGovern Medical School, Faillace Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ahn', 'Affiliation': 'UTHealth McGovern Medical School, Faillace Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Gabriela D', 'Initials': 'GD', 'LastName': 'Colpo', 'Affiliation': 'UTHealth McGovern Medical School, Faillace Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Juyoung', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'College of Social Work and Criminal Justice, Phyllis and Harvey Sandler School of Social Work, Florida Atlantic University, Boca Raton.'}, {'ForeName': 'Hyochol', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'College of Nursing, Florida State University, Tallahassee, FL.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000987']
2546,34757340,Ultrasound-guided Multiple Nerve Blocks: A Safe and Effective Anesthetic Modality in Geriatric Hip Fracture Patients.,"OBJECTIVES


The aim was to compare the feasibility of ultrasound-guided multiple nerve blocks (fascia iliaca compartment block+sacral plexus block+superior cluneal nerve block) with general anesthesia in geriatric hip fracture patients.
METHODS


Ninety-four patients were randomly divided into 2 groups: group N received ultrasound-guided multiple nerve blocks and group G received general anesthesia. Primary outcome measures included perioperative Pain Threshold Index (PTI) and Numerical Rating Scale. Secondary outcome measures comprised the following: (1) perioperative Delirium Index and Short Portable Mental Status Questionnaire; (2) perioperative Comfort Index; (3) perioperative opioid consumption (within 72 hours postoperatively); and (4) postoperative side effects (within 72 h postoperatively).
RESULTS


Eighty-seven patients completed the study. Baseline PTI was comparable between the groups. However, intraoperative PTI was significantly lower in group N than in group G. Preoperative and postoperative Comfort Index scores were comparable between the groups. Moderate delirium (24 to 72 h postoperatively) was significantly higher than the baseline in group G. Early moderate delirium (24 h postoperatively) was significantly higher in group G than in group N. Severe delirium was comparable between the groups and within each group. High intraoperative PTI was associated with high opioid consumption. The intravenous sufentanil dose in group G was twice of that in group N. Incidence of nausea and vomiting was similar between the groups.
DISCUSSION


Ultrasound-guided multiple nerve blockade may be an alternative to the common anesthetic procedures used for geriatric hip fracture patients. It provided satisfactory intraoperative pain management and reduced early postoperative cognitive disorders.",2021,"However, intraoperative PTI was significantly lower in group N than in group G. Preoperative and postoperative Comfort Index scores were comparable between the groups.","['Ninety-four patients', 'Eighty-seven patients completed the study', 'geriatric hip fracture patients', 'Geriatric Hip Fracture Patients']","['ultrasound-guided multiple nerve blocks (fascia iliaca compartment block+sacral plexus block+superior cluneal nerve block', 'ultrasound-guided multiple nerve blocks and group G received general anesthesia', 'sufentanil', 'Ultrasound-guided Multiple Nerve Blocks']","['following: (1) perioperative Delirium Index and Short Portable Mental Status Questionnaire; (2) perioperative Comfort Index; (3) perioperative opioid consumption (within 72 hours postoperatively); and (4) postoperative side effects', 'nausea and vomiting', 'Severe delirium', 'Baseline PTI', 'Moderate delirium', 'intraoperative PTI', 'postoperative Comfort Index scores', 'perioperative Pain Threshold Index (PTI) and Numerical Rating Scale', 'moderate delirium']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0441841', 'cui_str': 'Group G'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0451291', 'cui_str': 'Mental status questionnaire'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",94.0,0.045885,"However, intraoperative PTI was significantly lower in group N than in group G. Preoperative and postoperative Comfort Index scores were comparable between the groups.","[{'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Naval Medical University.'}, {'ForeName': 'Eerdun', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Navy 971 Hospital of PLA, Qingdao, Shandong, China.'}, {'ForeName': 'Shiyun', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Naval Medical University.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Fengying', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Navy 971 Hospital of PLA, Qingdao, Shandong, China.'}, {'ForeName': 'Zijin', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Xingying', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Naval Medical University.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000988']
2547,34757312,"A placebo-controlled, randomised pilot trial of N-acetylcysteine or placebo for cessation of tobacco smoking.","Smoking represents a significant health threat to the population, however there remains a core group of consistent smokers that are largely unable to break the addiction. Novel therapies are required to assist this group with cessation. N-acetylcysteine (NAC) is a nutraceutical supplement that has shown efficacy compared to placebo in previous pilot studies for assisting smokers to quit or reduce their consumption of cigarettes. A double-blind, randomised trial with a treatment period of 16 weeks and a final follow-up at 42 weeks was conducted comparing 1.8g of effervescent NAC per day (n=47) with placebo (n=47) as an aide to smoking cessation. Both study arms received adjunctive online support through the QuitCoach program. Participants reported smoking at each timepoint (baseline and weeks 8, 16 & 42), which was confirmed through salivary cotinine and exhaled carbon monoxide testing. Primary and secondary analyses were undertaken using a modified intent-to-treat basis, including all participants with at least one valid post baseline outcome, regardless of treatment received or their withdrawal from the study. There was no significant difference in smoking outcomes between intervention groups among the 24 participants that competed follow-up. There were no significant differences in age, gender, or body mass index (BMI) between the groups lost to follow-up or recorded at follow-up. This study found no evidence to support NAC as a therapy for smoking cessation. The negative outcome could be the result of lack of treatment efficacy, or alternatively, small sample size, participant retention difficulties, dose, or duration of follow-up. Trial Registration: Australian New Zealand Clinical Trials registry (ANZCTR), ACTRN12617001478303. Registered on 19 October 2017.",2021,"There were no significant differences in age, gender, or body mass index (BMI) between the groups lost to follow-up or recorded at follow-up.",[],"['effervescent NAC', 'N-acetylcysteine (NAC', 'adjunctive online support through the QuitCoach program', 'N-acetylcysteine or placebo', 'placebo']","['smoking outcomes', 'lack of treatment efficacy, or alternatively, small sample size, participant retention difficulties, dose, or duration of follow-up', 'salivary cotinine and exhaled carbon monoxide testing', 'age, gender, or body mass index (BMI']",[],"[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.377411,"There were no significant differences in age, gender, or body mass index (BMI) between the groups lost to follow-up or recorded at follow-up.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Arancini', 'Affiliation': 'Deakin University, IMPACT, the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, VIC, Australia. Electronic address: lauren.arancini@deakin.edu.au.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Deakin University, Faculty of Health, Biostatistics Unit, Geelong, VIC, Australia. Electronic address: m.mohebbi@deakin.edu.au.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'Deakin University, IMPACT, the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, VIC, Australia; University Hospital Geelong, Barwon Health, Geelong, VIC, Australia; Department of Psychiatry, the University of Melbourne, Parkville, VIC, Australia; Orygen, the National Centre for Excellence in Youth Mental Health, Parkville, VIC, Australia; Florey Institute of Neuroscience and Mental Health, Parkville, VIC, Australia. Electronic address: michael.berk@barwonhealth.org.au.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'Deakin University, IMPACT, the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, VIC, Australia; University Hospital Geelong, Barwon Health, Geelong, VIC, Australia; Department of Psychiatry, the University of Melbourne, Parkville, VIC, Australia; Florey Institute of Neuroscience and Mental Health, Parkville, VIC, Australia. Electronic address: o.dean@deakin.edu.au.'}, {'ForeName': 'Chiara C', 'Initials': 'CC', 'LastName': 'Bortolasci', 'Affiliation': 'Deakin University, IMPACT, the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, VIC, Australia. Electronic address: chiara.b@deakin.edu.au.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Spolding', 'Affiliation': 'Deakin University, IMPACT, the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, VIC, Australia.'}, {'ForeName': 'Robson', 'Initials': 'R', 'LastName': 'Zazula', 'Affiliation': 'Federal University for Latin American Integration, Foz do Iguacu, Brazil.'}, {'ForeName': 'Seetal', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'Deakin University, IMPACT, the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, VIC, Australia; University Hospital Geelong, Barwon Health, Geelong, VIC, Australia; Department of Psychiatry, the University of Melbourne, Parkville, VIC, Australia; Orygen, the National Centre for Excellence in Youth Mental Health, Parkville, VIC, Australia. Electronic address: seetald@barwonhealth.org.au.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2021.10.002']
2548,34757704,Immediate effect of cold mud pack therapy on autonomic variables in primary hypertensive individuals: a randomized trial.,"OBJECTIVES


Mud pack or compress is an easily accessible, cost-effective, efficient treatment modality used in naturopathy to manage and prevent various chronic illnesses. This study sought to elucidate the effectiveness of cold spinal mud packs on improving neuro-cardiac parameters among hypertensive individuals.
METHODS


A total of 100 hypertensive subjects aged 30-50 years were randomly allocated into two groups: Cold spinal mud pack (CSMP) and prone rest. Blood Pressure (BP) and Heart Rate Variability (HRV) were assessed at three-time points: Baseline, After 20 min (T1), After 60 min (T2). This single-blinded randomized controlled trial was registered in the Clinical Trials Registry-India (CTRI/2019/12/022492).
RESULTS


After 20 min of CSMP showed a statistically significant reduction (p<0.01) in mean values of Systolic BP, Diastolic BP, and in HRV attained statistically significant change (p<0.01) in mean score in the frequency domain except for Very low-frequency power (VLF) and a significant difference found in the mean score of time-domain values (p<0.01) when compared to control group and 95% confidence interval (CI) will be provided for each effect.
CONCLUSIONS


CSMP reduces the sympathetic tone and shifts the sympathovagal balance in favor of parasympathetic dominance, contributing to a decrease in BP and effective changes in components of HRV.",2021,"After 20 min of CSMP showed a statistically significant reduction (p<0.01) in mean values of Systolic BP, Diastolic BP, and in HRV attained statistically significant change (p<0.01) in mean score in the frequency domain except for Very low-frequency power (VLF) and a significant difference found in the mean score of time-domain values (p<0.01) when compared to control group and 95% confidence interval (CI) will be provided for each effect.
","['hypertensive individuals', '100 hypertensive subjects aged 30-50 years', 'primary hypertensive individuals']","['CSMP', 'cold mud pack therapy', 'cold spinal mud packs', 'Cold spinal mud pack (CSMP) and prone rest']","['mean score of time-domain values', 'neuro-cardiac parameters', 'autonomic variables', 'mean values of Systolic BP, Diastolic BP, and in HRV', 'Blood Pressure (BP) and Heart Rate Variability (HRV']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0949364', 'cui_str': 'Mud Packs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",100.0,0.179827,"After 20 min of CSMP showed a statistically significant reduction (p<0.01) in mean values of Systolic BP, Diastolic BP, and in HRV attained statistically significant change (p<0.01) in mean score in the frequency domain except for Very low-frequency power (VLF) and a significant difference found in the mean score of time-domain values (p<0.01) when compared to control group and 95% confidence interval (CI) will be provided for each effect.
","[{'ForeName': 'Abitone', 'Initials': 'A', 'LastName': 'Valsakumar', 'Affiliation': 'Department of Naturopathy, SDM College of Naturopathy and Yogic Sciences, Affiliated to RGUHS, Bangalore, Karnataka, India.'}, {'ForeName': 'Sujatha', 'Initials': 'S', 'LastName': 'Dinesh', 'Affiliation': 'Division of Natural Therapeutics, SDM College of Naturopathy and Yogic Sciences, Affiliated to RGUHS, Bangalore, Karnataka, India.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Prasad', 'Affiliation': 'Department of Naturopathy, SDM College of Naturopathy and Yogic Sciences, Affiliated to RGUHS, Bangalore, Karnataka, India.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Shetty', 'Affiliation': 'SDM College of Naturopathy and Yogic Sciences, Affiliated to RGUHS, Bangalore, Karnataka, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2021-0421']
2549,34757701,Sociodemographic factors affecting perceived stress during pregnancy and the association with immune-mediator concentrations.,"OBJECTIVES


Determine which sociodemographic factors are most associated with increased maternal perceived stress during pregnancy. Evaluate the association between maternal stress and plasma immune-mediator concentrations (IMCs).
METHODS


As part of a prospective, randomized clinical trial, 247 participants completed a Perceived Stress Scale survey (PSS-10) during each trimester of pregnancy. Blood samples were collected from participants and were analyzed for 25-hydroxyvitamin D (25(OH)D) concentration and for several IMCs: interferon-gamma, interleukins (IL-) IL-2, IL-4, IL-5, IL-10, vascular endothelial growth factor, c-reactive protein, and tumor necrosis factor alpha (TNF- α ) (R&D Elisa). The potential associations between PSS-10 scores, sociodemographic factors, and IMCs were assessed.
RESULTS


In bivariate analysis, participants who were not married and/or had high risk pregnancies were more likely to have increased PSS-10 scores (p<0.05). Increased PSS-10 scores were associated with higher serum concentrations of IL-2 and TNF- α , and decreased concentrations of IL-10 and 25(OH)D. In linear regression analysis, single marital status, high-risk pregnancy, IL-2, and TNF- α  were independent predictors of PSS-10 scores.
CONCLUSIONS


This study identifies specific sociodemographic factors that are associated with increased perceived stress during pregnancy. This study also provides evidence that increased perceived stress is associated with physiological changes as measured by changes in circulating IL-2, TNF- α , IL-10, and 25(OH)D concentrations.",2021,"Increased PSS-10 scores were associated with higher serum concentrations of IL-2 and TNF- α , and decreased concentrations of IL-10 and 25(OH)D.","['247 participants completed a Perceived Stress Scale survey (PSS-10) during each trimester of pregnancy', 'participants who were not married and/or had high risk pregnancies']",[],"['single marital status, high-risk pregnancy, IL-2, and TNF- α', 'PSS-10 scores', 'maternal stress and plasma immune-mediator concentrations (IMCs', 'PSS-10 scores, sociodemographic factors, and IMCs', '25-hydroxyvitamin D (25(OH)D) concentration and for several IMCs: interferon-gamma, interleukins (IL-) IL-2, IL-4, IL-5, IL-10, vascular endothelial growth factor, c-reactive protein, and tumor necrosis factor alpha (TNF- α ) (R&D Elisa', 'Increased PSS-10 scores', 'serum concentrations of IL-2 and TNF- α , and decreased concentrations of IL-10 and 25(OH)D', 'circulating IL-2, TNF- α , IL-10, and 25(OH)D concentrations']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0242786', 'cui_str': 'High risk pregnancy'}]",[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0242786', 'cui_str': 'High risk pregnancy'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",247.0,0.22562,"Increased PSS-10 scores were associated with higher serum concentrations of IL-2 and TNF- α , and decreased concentrations of IL-10 and 25(OH)D.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'McLeod', 'Affiliation': ""College of Medicine, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, SC, USA.""}, {'ForeName': 'Myla D', 'Initials': 'MD', 'LastName': 'Ebeling', 'Affiliation': ""Division of Neonatology, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, SC, USA.""}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Baatz', 'Affiliation': ""Division of Neonatology, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, SC, USA.""}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Shary', 'Affiliation': ""Division of Neonatology, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, SC, USA.""}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Mulligan', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Florida-Gainesville, Gainesville, FL, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Wagner', 'Affiliation': ""Division of Neonatology, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, SC, USA.""}]",Journal of perinatal medicine,['10.1515/jpm-2021-0227']
2550,34757700,"Effect of a Persian metabolic diet on the functional dyspepsia symptoms in patients with postprandial distress syndrome: a randomized, double-blind clinical trial.","OBJECTIVES


Postprandial distress syndrome (PDS) is associated with food indigestion. Efficacy of drugs used against PDS is limited whereas dietary modifications were shown to have important beneficial effects. Traditional Persian Medicine (TPM) sages suggested a dietary regimen known as Persian metabolic diet (PMD) for the management of PDS patients. In this study, the efficacy of PMD in alleviating the symptoms of PDS was explored.
METHODS


This single-center, parallel-group, randomized clinical trial included 56 patients whom were randomly allocated to PMD group (29 participants) and Optional diet (OD) group (27 participants). They were instructed to follow the protocol for two weeks. Using a standard validated questionnaire, all outcomes were evaluated at baseline, end of the intervention period, and end of follow-up time.
RESULTS


At the end of the intervention period, comparing the changes of severity scores between the groups showed a statistically significant difference in week 2 (p-value<0.001) and week 8 (p-value<0.001) follow-up comparing to the baseline. Similarly, at the end of the follow-up period, epigastric fullness, epigastric discomfort, and bloating were significantly improved in the PMD group (p<0.001).
CONCLUSIONS


This diet prepared based on Persian medicine seems to be effective in relieving the symptoms of patients with PDS.",2021,"At the end of the intervention period, comparing the changes of severity scores between the groups showed a statistically significant difference in week 2 (p-value<0.001) and week 8 (p-value<0.001) follow-up comparing to the baseline.","['PDS patients', 'patients with PDS', '56 patients', 'patients with postprandial distress syndrome']","['Persian metabolic diet', 'Optional diet (OD', 'PMD']","['Postprandial distress syndrome (PDS', 'epigastric fullness, epigastric discomfort, and bloating', 'functional dyspepsia symptoms', 'changes of severity scores']","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0452399', 'cui_str': 'Metabolic diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0232570', 'cui_str': 'Epigastric fullness'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",56.0,0.0847632,"At the end of the intervention period, comparing the changes of severity scores between the groups showed a statistically significant difference in week 2 (p-value<0.001) and week 8 (p-value<0.001) follow-up comparing to the baseline.","[{'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Nouri', 'Affiliation': 'Department of Traditional Persian Medicine, Faculty of Medicine, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Naseri', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Abdi', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soghrat', 'Initials': 'S', 'LastName': 'Faghihzadeh', 'Affiliation': 'Epidemiology and Biostatistics Department, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Pasalar', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Mohammadi Farsani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Zali', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2021-0368']
2551,34757657,Effects of food on the pharmacokinetics of ensartinib in healthy Chinese subjects.,"Ensartinib is a promising, aminopyridazine-based small molecule that potently inhibits anaplastic lymphoma kinase. This random, two-period, crossover study evaluated the effects of food on the pharmacokinetics of ensartinib after a single dose (225 mg) in healthy Chinese subjects. The pharmacokinetic parameters of ensartinib were calculated using non-compartmental analysis. Twenty-four Chinese healthy subjects aged 20-44 years were included in this study. The area under the concentration-time curve of ensartinib was approximately 25% lower after the intake of a high-fat, high-calorie meal prior to dosing, whereas the maximum plasma concentration was decreased by approximately 37%, illustrating the statistically significant effect of food on ensartinib pharmacokinetics. In addition, food intake prolonged the absorption phase of ensartinib (median time to maximum plasma concentration, from 4.5 to 6 h). Population pharmacokinetic (PopPK) analysis was conducted using NONMEM, and the influences of food, age, sex, body weight, and body mass index were studied via covariate analysis. In this analysis, ensartinib plasma concentrations were best described by a one-compartment model with Weibull absorption. The final model included food and age as covariates on apparent distribution and apparent clearance. Based on the final PopPK model, food was identified as a significant covariate for apparent clearance, apparent volume of distribution, and absorption rate constant, consistent with the results of non-compartmental pharmacokinetic analysis.",2021,"Based on the final PopPK model, food was identified as a significant covariate for apparent clearance, apparent volume of distribution, and absorption rate constant, consistent with the results of non-compartmental pharmacokinetic analysis.","['Twenty-four Chinese healthy subjects aged 20-44 years', 'healthy Chinese subjects']",[],"['ensartinib pharmacokinetics', 'ensartinib plasma concentrations', 'area under the concentration-time curve of ensartinib', 'maximum plasma concentration']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C4524311', 'cui_str': 'ensartinib'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",24.0,0.0158527,"Based on the final PopPK model, food was identified as a significant covariate for apparent clearance, apparent volume of distribution, and absorption rate constant, consistent with the results of non-compartmental pharmacokinetic analysis.","[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Shao', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, 310009, PR China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, 310009, PR China.'}, {'ForeName': 'Zourong', 'Initials': 'Z', 'LastName': 'Ruan', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, 310009, PR China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, 310009, PR China.'}, {'ForeName': 'Wanlin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Betta Pharmaceuticals Co., Ltd, Hangzhou, Zhejiang, 311100, PR China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Betta Pharmaceuticals Co., Ltd, Hangzhou, Zhejiang, 311100, PR China.'}, {'ForeName': 'Honggang', 'Initials': 'H', 'LastName': 'Lou', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, 310009, PR China.'}, {'ForeName': 'Jingliang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, 310009, PR China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, 310009, PR China.'}]",Clinical and experimental pharmacology & physiology,['10.1111/1440-1681.13611']
2552,34757654,Validation of a test meal paradigm to experimentally manipulate meal-related fears: A registered report.,"Fear is central to conceptualizations of weight and shape-focused eating disorders. The current study will examine the reliability and validity of a test meal paradigm that varies perceptions of fat content to manipulate fear. Undergraduate women with elevated eating pathology (N = 96) will be randomized to one of three test meal conditions: two ""low"" fat yogurts, two ""high"" fat yogurts, or one ""high"" fat and one ""low"" fat yogurt. In actuality, all yogurts will have the same fat content. Supporting reliability, we hypothesize that self-reported fear and electrodermal activity (psychophysiological index of fear-related arousal) will exhibit good test-retest reliability over a 48-hr period in the ""high"" fat/""high"" fat and ""low"" fat/""low"" fat conditions. Supporting construct validity, self-reported fear and electrodermal activity will be elevated during the ""high"" versus ""low"" fat condition and responses to the ""high"" fat condition will correlate with fear of food, eating, and weight gain. Supporting discriminant validity, self-reported disgust and anger will be comparable in the ""high"" and ""low"" fat conditions and will exhibit weak correlations with trait measures of disgust and anger. This experimental paradigm will allow researchers to manipulate fear in order understand the mechanisms by which fear maintains eating pathology.",2021,"Undergraduate women with elevated eating pathology (N = 96) will be randomized to one of three test meal conditions: two ""low"" fat yogurts, two ""high"" fat yogurts, or one ""high"" fat and one ""low"" fat yogurt.",['Undergraduate women with elevated eating pathology (N\xa0=\u200996'],"['low"" fat yogurts, two ""high"" fat yogurts, or one ""high"" fat and one ""low"" fat yogurt']",['fear and electrodermal activity (psychophysiological index of fear-related arousal'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",96.0,0.0269227,"Undergraduate women with elevated eating pathology (N = 96) will be randomized to one of three test meal conditions: two ""low"" fat yogurts, two ""high"" fat yogurts, or one ""high"" fat and one ""low"" fat yogurt.","[{'ForeName': 'K Jean', 'Initials': 'KJ', 'LastName': 'Forney', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Jenny H', 'Initials': 'JH', 'LastName': 'Jo', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pucci', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}]",The International journal of eating disorders,['10.1002/eat.23637']
2553,34757600,Influence of Fasting Plasma Glucose Targets on Glycemic Variability in Chinese Participants With Type 2 Diabetes: A Post Hoc Analysis of the FPG GOAL Trial (BEYOND III).,"INTRODUCTION


This post hoc analysis examines the relationship between glycemic variability (GV) and fasting plasma glucose (FPG) targets used to achieve glycated hemoglobin (HbA1c) < 7%, and HbA1c levels after 24 weeks of treatment with insulin glargine and oral antidiabetic drugs (OADs) in Chinese participants with type 2 diabetes mellitus (T2DM) from the BEYOND III FPG GOAL trial (NCT02545842).
METHODS


Participants were randomized for three FBG targets (≤ 5.6 mmol/L, ≤ 6.1 mmol/L, and ≤ 7.0 mmol/L) receiving insulin glargine 100 U/mL were analyzed for mean change from baseline to 24 weeks in postprandial glucose (PPG) excursion and FPG coefficient of variation (FPG-CV). The study analyzed change from baseline in HbA1c and the proportion of participants who achieved HbA1c < 7% at 24 weeks, according to their baseline FPG-CV and change from baseline in PPG excursion.
RESULTS


The change in PPG excursion and FPG-CV from baseline to 24 weeks was not significantly different between the three groups stratified by randomization or by 24-week FPG levels. While the change in HbA1c from baseline to 24 weeks was slightly higher among participants with baseline FPG-CV < 33.3% (vs. > 66.7%; P = 0.023), a higher proportion of participants with baseline FPG-CV < 33.3% achieved HbA1c < 7% (P = 0.021).
CONCLUSIONS


GV was not associated with either target FPG levels or HbA1c < 7.0% after 24 weeks of treatment with insulin glargine and OADs.
TRIAL REGISTRATION


Clinicaltrials.gov identifier NCT02545842.",2021,The change in PPG excursion and FPG-CV from baseline to 24 weeks was not significantly different between the three groups stratified by randomization or by 24-week FPG levels.,"['HbA1c and the proportion of participants who achieved HbA1c\xa0<\xa07% at 24\xa0weeks, according to their baseline FPG-CV and change from baseline in PPG excursion', 'Chinese Participants With Type 2 Diabetes', 'Chinese participants with type 2 diabetes mellitus (T2DM', 'participants with baseline FPG-CV', 'Participants']","['Fasting Plasma Glucose Targets', 'insulin glargine and oral antidiabetic drugs (OADs', 'insulin glargine', 'FBG targets (≤\xa05.6\xa0mmol/L,\xa0≤\xa06.1\xa0mmol/L, and\xa0≤\xa07.0\xa0mmol/L) receiving insulin glargine']","['glycemic variability (GV) and fasting plasma glucose (FPG) targets', 'Glycemic Variability', 'target FPG levels or HbA1c', 'postprandial glucose (PPG) excursion and FPG coefficient of variation (FPG-CV', 'HbA1c levels', 'glycated hemoglobin (HbA1c', 'PPG excursion and FPG-CV']","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]","[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.327852,The change in PPG excursion and FPG-CV from baseline to 24 weeks was not significantly different between the three groups stratified by randomization or by 24-week FPG levels.,"[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Yaoming', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Nanfang Hospital, Guangzhou, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Ruan', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Yunguang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""China-Japan Friendship Hospital, East Yinghuayuan Street, Hepingli, Beijing, 100029, People's Republic of China. ywying_1010@163.com.""}]",Advances in therapy,['10.1007/s12325-021-01932-2']
2554,34757584,Examining Ways to Improve Weight Control Programs' Population Reach and Representativeness: A Discrete Choice Experiment of Financial Incentives.,"BACKGROUND


Both theoretical and empirical evidence supports the potential of modest financial incentives to increase the reach of evidence-based weight control programs. However, few studies exist that examine the best incentive design for achieving the highest reach and representativeness at the lowest cost and whether or not incentive designs may be valued differentially by subgroups that experience obesity-related health disparities.
METHODS


A discrete choice experiment was conducted (n = 1232 participants; over 90% of them were overweight/obese) to collect stated preference towards different financial incentive attributes, including reward amount, program location, reward contingency, and payment form and frequency. Mixed logit and conditional logit models were used to determine overall and subgroup preference ranking of attributes. Using the National Health and Nutrition Examination Survey data sample weights and the estimated models, we predicted US nationally representative participation rates by subgroups and examined the effect of offering more than one incentive design. External validity was checked by using a completed cluster randomized control trial.
RESULTS


There were significant subgroup differences in preference toward incentive attributes. There was also a sizable negative response to larger incentive amounts among African Americans, suggesting that higher amounts would reduce participation from this population. We also find that offering participants a menu of incentive designs to choose from would increase reach more than offering higher reward amounts.
CONCLUSIONS


We confirmed the existence of preference heterogeneity and the importance of subgroup-targeted incentive designs in any evidence-based weight control program to maximize population reach and reduce health disparities.",2021,There were significant subgroup differences in preference toward incentive attributes.,"['Representativeness', 'A discrete choice experiment was conducted (n\xa0=\xa01232 participants; over 90% of them were overweight/obese', 'African Americans']",[],"['preference toward incentive attributes', 'External validity']","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0085756', 'cui_str': 'African American'}]",[],"[{'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",1232.0,0.0795207,There were significant subgroup differences in preference toward incentive attributes.,"[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Department of Public Health Science, School of Medicine, University of Virginia, University of Virginia Cancer Center, Charlottesville, VA, USA. wenyou@virginia.edu.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Convoy Inc., Seattle, WA, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Boyle', 'Affiliation': 'Department of Agricultural and Applied Economics, Willis Blackwood Real Estate, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Tzeyu L', 'Initials': 'TL', 'LastName': 'Michaud', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Parmeter', 'Affiliation': 'Department of Economics, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Seidel', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Virginia Tech Carilion School of Medicine, Roanoke, VA, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE, USA.'}]",PharmacoEconomics - open,['10.1007/s41669-021-00310-6']
2555,34757573,Capacity Building of Frontline Workers for Detection of Children (0-6 Years) with Developmental Delays in a Rural Setting: A Cluster-Randomized Trial.,"INTRODUCTION


Development during the early stage of life i.e. in the first 1000 d is crucial in determining the psychosocial productivity of a child in the future. Frontline workers (FLWs) are not trained to detect of developmental delays (DDs) in children under the national programme of Rashtriya Bal Swasthya Karyakram (RBSK) in India.
OBJECTIVE


To train the FLWs and assess the effectiveness of a training strategy in detection of DDs in children less than 6 y of age using a cluster-randomized trial approach.
METHODS


A community-based interventional study was conducted in Khurdha district of Odisha. Training was imparted to FLWs in intervention arm using a training module developed in regional language. Knowledge level of FLWs was assessed before and after the training in both study arms using a structured questionnaire, and data were analyzed in IBM SPSS 22. Outcomes were compared using chi square, Student t (both paired and unpaired) and Man-Whitney U test. After 3 mo of intervention, the investigator examined a sample of children (intervention arm: 870, control arm: 847) for DDs using the Denver Developmental Screening Test II.
RESULTS


The mean difference in knowledge scores of FLWs was found to be 7.26 (8.8 to 5.7) and 1.11 (1.38 to 0.84) in intervention and control arm, respectively. Case detection rate by FLWs in intervention and control arm was 61.5% and 9.09%, respectively.
CONCLUSION


Capacity building of the FLWs should be considered by the government for integrating them in the Rashtriya Bal Swasthya Karyakram (RBSK) programme for screening children.",2021,"Case detection rate by FLWs in intervention and control arm was 61.5% and 9.09%, respectively.
","['Frontline Workers\xa0for Detection of Children (0-6 Years) with Developmental Delays in a Rural Setting', 'children under the national programme of Rashtriya Bal Swasthya Karyakram (RBSK) in India', 'A community-based interventional study was conducted in Khurdha district of Odisha', 'children less than 6 y of age using a cluster-randomized trial approach']",[],"['Knowledge level of FLWs', 'knowledge scores of FLWs', 'Case detection rate by FLWs']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0012383', 'cui_str': 'Dimercaprol'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],"[{'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",,0.0363512,"Case detection rate by FLWs in intervention and control arm was 61.5% and 9.09%, respectively.
","[{'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Dora', 'Affiliation': 'Department of Community Medicine & Family Medicine, AIIMS, Bhubaneswar, Odisha, 751019, India. susmitadora90@gmail.com.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Bhatia', 'Affiliation': 'Department of Community Medicine & Family Medicine, AIIMS, Bhubaneswar, Odisha, 751019, India.'}, {'ForeName': 'Binod Kumar', 'Initials': 'BK', 'LastName': 'Behera', 'Affiliation': 'Department of Community Medicine & Family Medicine, AIIMS, Bhubaneswar, Odisha, 751019, India.'}, {'ForeName': 'Amit Kumar', 'Initials': 'AK', 'LastName': 'Satapathy', 'Affiliation': 'Department of Pediatrics, AIIMS, Bhubaneswar, Odisha, India.'}]",Indian journal of pediatrics,['10.1007/s12098-021-03912-4']
2556,34757564,Effects of a physical activity intervention on brain atrophy in older adults at risk of dementia: a randomized controlled trial.,"Lack of physical activity is a risk factor for dementia, however, the utility of interventional physical activity programs as a protective measure against brain atrophy and cognitive decline is uncertain. Here we present the effect of a randomized controlled trial of a 24-month physical activity intervention on global and regional brain atrophy as characterized by longitudinal voxel-based morphometry with T1-weighted MRI images. The study sample consisted of 98 participants at risk of dementia, with mild cognitive impairment or subjective memory complaints, and having at least one vascular risk factor for dementia, randomized into an exercise group and a control group. Between 0 and 24 months, there was no significant difference detected between groups in the rate of change in global, or regional brain volumes.",2021,"Between 0 and 24 months, there was no significant difference detected between groups in the rate of change in global, or regional brain volumes.","['98 participants at risk of dementia, with mild cognitive impairment or subjective memory complaints, and having at least one vascular risk factor for dementia, randomized into an exercise group and a control group', 'older adults at risk of dementia']",['physical activity intervention'],"['brain atrophy', 'global and regional brain atrophy', 'rate of change in global, or regional brain volumes']","[{'cui': 'C3697373', 'cui_str': 'At risk of dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",98.0,0.0738518,"Between 0 and 24 months, there was no significant difference detected between groups in the rate of change in global, or regional brain volumes.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Sinclair', 'Affiliation': 'Department of Radiology, University of Melbourne, Melbourne, Australia. benjamin.james.sinclair@gmail.com.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Steward', 'Affiliation': 'Department of Radiology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Venkatraman', 'Affiliation': 'Department of Radiology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Rowa', 'Initials': 'R', 'LastName': 'Aljondi', 'Affiliation': 'Department of Radiology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Ellis', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ames', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Colin L', 'Initials': 'CL', 'LastName': 'Masters', 'Affiliation': 'The Florey Institute, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Pramit M', 'Initials': 'PM', 'LastName': 'Phal', 'Affiliation': 'Department of Radiology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Sharman', 'Affiliation': 'School of Health Science, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Elizabeth V', 'Initials': 'EV', 'LastName': 'Cyarto', 'Affiliation': 'Bolton Clarke Research Institute, Brisbane, Australia.'}, {'ForeName': 'Michelle M Y', 'Initials': 'MMY', 'LastName': 'Lai', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Szoeke', 'Affiliation': 'University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': 'University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Desmond', 'Affiliation': 'Department of Radiology, University of Melbourne, Melbourne, Australia.'}]",Brain imaging and behavior,['10.1007/s11682-021-00577-7']
2557,33893329,Augmenting ideational fluency in a creativity task across multiple transcranial direct current stimulation montages.,"Neuroimaging and transcranial direct current stimulation (tDCS) research has revealed that generating novel ideas is associated with both reductions and increases in prefrontal cortex (PFC) activity, and engagement of posterior occipital cortex, among other regions. However, there is substantial variability in the robustness of these tDCS-induced effects due to heterogeneous sample sizes, different creativity measures, and methodological diversity in the application of tDCS across laboratories. To address these shortcomings, we used twelve different montages within a standardized tDCS protocol to investigate how altering activity in frontotemporal and occipital cortex impacts creative thinking. Across four experiments, 246 participants generated either the common or an uncommon use for 60 object pictures while undergoing tDCS. Participants also completed a control short-term memory task. We applied active tDCS for 20 min at 1.5 mA through two 5 cm × 5 cm electrodes over left or right ventrolateral prefrontal (areas F7, F8) or occipital (areas O1, O2) cortex, concurrent bilateral stimulation of these regions across polarities, or sham stimulation. Cathodal stimulation of the left, but not right, ventrolateral PFC improved fluency in creative idea generation, but had no effects on originality, as approximated by measures of semantic distance. No effects were obtained for the control tasks. Concurrent bilateral stimulation of the ventrolateral PFC regardless of polarity direction, and excitatory stimulation of occipital cortex did not alter task performance. Highlighting the importance of cross-experimental methodological consistency, these results extend our past findings and contribute to our understanding of the role of left PFC in creative thinking.",2021,"Cathodal stimulation of the left, but not right, ventrolateral PFC improved fluency in creative idea generation, but had no effects on originality, as approximated by measures of semantic distance.",['246 participants generated either the common or an uncommon use for 60 object pictures while undergoing tDCS'],"['active tDCS for 20\xa0min at 1.5\xa0mA through two 5\xa0cm\u2009×\u20095\xa0cm electrodes over left or right ventrolateral prefrontal (areas F7, F8) or occipital (areas O1, O2) cortex, concurrent bilateral stimulation of these regions across polarities, or sham stimulation', 'Neuroimaging and transcranial direct current stimulation (tDCS', 'control short-term memory task']","['task performance', 'prefrontal cortex (PFC) activity, and engagement of posterior occipital cortex']","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0522498', 'cui_str': 'Rare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]","[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0028785', 'cui_str': 'Occipital lobe structure'}]",246.0,0.0374272,"Cathodal stimulation of the left, but not right, ventrolateral PFC improved fluency in creative idea generation, but had no effects on originality, as approximated by measures of semantic distance.","[{'ForeName': 'Evangelia G', 'Initials': 'EG', 'LastName': 'Chrysikou', 'Affiliation': 'Department of Psychology, Drexel University, 3201 Chestnut St., Philadelphia, PA, 19140, USA. lilachrysikou@drexel.edu.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Morrow', 'Affiliation': 'University of Connecticut, Storrs, USA.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Flohrschutz', 'Affiliation': 'University of Arizona, Tucson, USA.'}, {'ForeName': 'Lauryn', 'Initials': 'L', 'LastName': 'Denney', 'Affiliation': 'University of Kansas Medical Center, Kansas City, USA.'}]",Scientific reports,['10.1038/s41598-021-85804-3']
2558,34288956,Substance use behavior and its lifestyle-related risk factors in Bangladeshi high school-going adolescents: An exploratory study.,"Substance abuse is a major concern worldwide and is increasing rapidly in Bangladesh. However, there are no prior studies concerning lifestyle-related factors that influence adolescents' substance use behavior. Therefore, the present study investigated the prevalence of substance use and its associated sociodemographic and lifestyle-related risk factors among a total of 424 Bangladeshi high school-going adolescents through a structured questionnaire interview study. The survey questionnaire consisted of socio-demographics, lifestyle-related information, and substance use-related questions. For data analysis, descriptive and inferential statistics were performed using SPSS (Statistical Package for Social Science) version 22.0, and a p-value of <0.05 determined statistical significance. Results showed that 21.2%, 14.4%, and 15.1% of the participants reported smoking, using a drug, and consuming alcohol, respectively, at least once during their lifespan; whereas the current (i.e., past-month) rates were reported to be 10.4%, 2.8%, and 3.1%, respectively. Overall, the current substance use risk factors were identified as being male, not being from science academic background, having less family influence on personal life, irregular teeth brushing, being smartphone users, using a smartphone for a longer time, and being late-night sleepers. From the list of identified risk factors of substance use, those that are modifiable may be targeted to evolve a prevention program to manage this problem in Bangladeshi adolescents.",2021,"Results showed that 21.2%, 14.4%, and 15.1% of the participants reported smoking, using a drug, and consuming alcohol, respectively, at least once during their lifespan; whereas the current (i.e., past-month) rates were reported to be 10.4%, 2.8%, and 3.1%, respectively.","['Bangladeshi high school-going adolescents', '424 Bangladeshi high school-going adolescents through a structured questionnaire interview study']",[],[],"[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],424.0,0.00904284,"Results showed that 21.2%, 14.4%, and 15.1% of the participants reported smoking, using a drug, and consuming alcohol, respectively, at least once during their lifespan; whereas the current (i.e., past-month) rates were reported to be 10.4%, 2.8%, and 3.1%, respectively.","[{'ForeName': 'Mst Sabrina', 'Initials': 'MS', 'LastName': 'Moonajilin', 'Affiliation': 'Department of Public Health and Informatics, Jahangirnagar University, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Md Khalid Ibne', 'Initials': 'MKI', 'LastName': 'Kamal', 'Affiliation': 'Department of Public Health and Informatics, Jahangirnagar University, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Firoj Al', 'Initials': 'FA', 'LastName': 'Mamun', 'Affiliation': 'Department of Public Health and Informatics, Jahangirnagar University, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Mariam Binte', 'Initials': 'MB', 'LastName': 'Safiq', 'Affiliation': 'CHINTA Research Bangladesh, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Hosen', 'Affiliation': 'Department of Public Health and Informatics, Jahangirnagar University, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Md Dilshad', 'Initials': 'MD', 'LastName': 'Manzar', 'Affiliation': ""Department of Nursing, College of Applied Medical Sciences, Majmaah University, Al Majma'ah, Saudi Arabia.""}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Mamun', 'Affiliation': 'Department of Public Health and Informatics, Jahangirnagar University, Savar, Dhaka, Bangladesh.'}]",PloS one,['10.1371/journal.pone.0254926']
2559,34294784,Association of blood pressure and renal outcome in patients with chronic kidney disease; a post hoc analysis of FROM-J study.,"It is well-known that hypertension exacerbates chronic kidney disease (CKD) progression, however, the optimal target blood pressure (BP) level in patients with CKD remains unclear. This study aimed to assess the optimal BP level for preventing CKD progression. The risk of renal outcome among different BP categories at baseline as well as 1 year after, were evaluated using individual CKD patient data aged between 40 and 74 years from FROM-J [Frontier of Renal Outcome Modifications in Japan] study. The renal outcome was defined as ≥ 40% reduction in estimated glomerular filtration rate to < 60 mL/min/1.73 m 2 , or a diagnosis of end stage renal disease. Regarding baseline BP, the group of systolic BP (SBP) 120-129 mmHg had the lowest risk of the renal outcome, which increased more than 60% in SBP ≥ 130 mmHg group. A significant increase in the renal outcome was found only in the group of diastolic BP ≥ 90 mmHg. The group of BP < 130/80 mmHg had a benefit for lowering the risk regardless of the presence of proteinuria, and it significantly reduced the risk in patients with proteinuria. Achieving SBP level < 130 mmHg after one year resulted in a 42% risk reduction in patients with SBP level ≥ 130 mmHg at baseline. Targeting SBP level < 130 mmHg would be associated with the preferable renal outcome.Clinical Trial Registration-URL: https://www.umin.ac.jp/ctr/ . Unique identifier: UMIN000001159 (16/05/2008).",2021,Achieving SBP level < 130 mmHg after one year resulted in a 42% risk reduction in patients with SBP level ≥ 130 mmHg at baseline.,['patients with chronic kidney disease'],[],"['Achieving SBP level', 'blood pressure and renal outcome', 'systolic BP (SBP', 'blood pressure (BP) level', 'renal outcome', 'glomerular filtration rate', 'optimal BP level', 'lowest risk of the renal outcome', 'diastolic BP\u2009≥']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",[],"[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.0635958,Achieving SBP level < 130 mmHg after one year resulted in a 42% risk reduction in patients with SBP level ≥ 130 mmHg at baseline.,"[{'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Tsuchida-Nishiwaki', 'Affiliation': 'Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama, Japan.'}, {'ForeName': 'Haruhito A', 'Initials': 'HA', 'LastName': 'Uchida', 'Affiliation': 'Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama, Japan. hauchida@okayama-u.ac.jp.'}, {'ForeName': 'Hidemi', 'Initials': 'H', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Nishiwaki', 'Affiliation': 'Department of Gastroenterological Surgery Transplant and Surgical Oncology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Maeshima', 'Affiliation': 'Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama, Japan.'}, {'ForeName': 'Chie', 'Initials': 'C', 'LastName': 'Saito', 'Affiliation': 'Department of Nephrology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wada', 'Affiliation': 'Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama, Japan.'}, {'ForeName': 'Ichiei', 'Initials': 'I', 'LastName': 'Narita', 'Affiliation': 'Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Science, Niigata, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Tokyo-Kita Medical Center, Kita-ward, Tokyo, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Matsuo', 'Affiliation': 'Nagoya University, Nagoya, Aichi, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Okayama University, Okayama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Hishida', 'Affiliation': 'Yaizu City Hospital, Shizuoka, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Yamagata', 'Affiliation': 'Department of Nephrology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}]",Scientific reports,['10.1038/s41598-021-94467-z']
2560,34293010,Long-term effect of botulinum toxin A on the hip and spine in cerebral palsy: A national retrospective cohort study in Taiwan.,"OBJECTIVES


To investigate the effect of botulinum toxin A (BTA) on the development of hip dislocation and scoliosis, surgical rates for hip and spine, and mortality in cerebral palsy (CP).
STUDY DESIGN


A cohort study was conducted using CP data from a Taiwan National Insurance Health Research Database. Diagnoses were defined using the International Classification of Diseases codes, 9th revision. Adjusted hazard ratios for outcomes were calculated using Cox regression analysis and adjusted for the following variables: BTA injection, sex, age, severities of CP, comorbidities, location, urbanization level, and level of care.
RESULTS


A total of 1,405 CP children (670 female vs. 735 male), 281 in the BTA group and 1,124 in the controls, were followed-up for a mean of 5 years 4 months. There were no significant differences in the outcomes in both groups, in the incidence rates of hip dislocation and scoliosis, nor in the surgical rates for hip and spine surgery. Mortality rate in the BTA group was 0.49 times lower than that in the controls (p = 0.001). Moderate to severe types of CP had higher incidence rates of hip dislocation, scoliosis, hip surgery, spine surgery, and mortality.
CONCLUSION


Moderate to severe types of CP had poorer outcomes in all aspects, including a higher risk of hip dislocation, scoliosis, surgical rate for hip and spine, and mortality. Although BTA injection in children with CP proved to not significantly reduce hip dislocation and scoliosis, it is considered safe as an anti-spasticity treatment and may be beneficial for survival.",2021,"There were no significant differences in the outcomes in both groups, in the incidence rates of hip dislocation and scoliosis, nor in the surgical rates for hip and spine surgery.","['A cohort study was conducted using CP data from a Taiwan National Insurance Health Research Database', '1,405 CP children (670 female vs. 735 male), 281 in the BTA group and 1,124 in the controls, were followed-up for a mean of 5 years 4 months', 'cerebral palsy', 'hip dislocation and scoliosis, surgical rates for hip and spine, and mortality in cerebral palsy (CP', 'children with CP', 'Taiwan']","['botulinum toxin A', 'BTA', 'botulinum toxin A (BTA']","['surgical rates for hip and spine surgery', 'higher risk of hip dislocation, scoliosis, surgical rate for hip and spine, and mortality', 'Mortality rate', 'hip dislocation, scoliosis, hip surgery, spine surgery, and mortality', 'hip dislocation and scoliosis', 'incidence rates of hip dislocation and scoliosis', 'severities of CP, comorbidities, location, urbanization level, and level of care']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019554', 'cui_str': 'Dislocation of hip joint'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019554', 'cui_str': 'Dislocation of hip joint'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0041938', 'cui_str': 'Urbanization'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1405.0,0.043799,"There were no significant differences in the outcomes in both groups, in the incidence rates of hip dislocation and scoliosis, nor in the surgical rates for hip and spine surgery.","[{'ForeName': 'Ching-Yueh', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Kaohsiung Armed Forces General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chi-Hsiang', 'Initials': 'CH', 'LastName': 'Chung', 'Affiliation': 'School of Public Health, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Matthews', 'Affiliation': ""Department of Physical Medicine and Rehabilitation, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO, United States of America.""}, {'ForeName': 'Heng-Yi', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'School of Medicine, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Liang-Cheng', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'School of Medicine, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Sung-Sen', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Research, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Wu-Chien', 'Initials': 'WC', 'LastName': 'Chien', 'Affiliation': 'School of Public Health, National Defense Medical Center, Taipei, Taiwan.'}]",PloS one,['10.1371/journal.pone.0255143']
2561,34465828,Prior intracerebral hemorrhage and white matter hyperintensity burden on recurrent stroke risk.,"Prior intracerebral hemorrhage (ICH) is associated with increased risk of ischemic stroke. Since white matter hyperintensity (WMH) is associated with ischemic stroke and ICH, this study aimed to evaluate the relationship between ICH and the risk of recurrent stroke by WMH severity. From a prospective multicenter database comprising 1454 noncardioembolic stroke patients with cerebral small-vessel disease, patients were categorized by presence or absence of prior ICH and WMH severity: mild-moderate WMH (reference); advanced WMH; ICH with mild-moderate WMH; and ICH with advanced WMH. Among patients with ICH, the association with stroke outcomes by WMH burden was further assessed. The primary endpoint was ischemic stroke and hemorrhagic stroke. The secondary endpoint was major adverse cardiovascular events (MACE): stroke/coronary heart disease/vascular death. During the mean 1.9-year follow-up period, the ischemic stroke incidence rate per 100 person-years was 2.7, 4.0, 2.5, and 8.1 in increasing severity, and the rate of hemorrhagic stroke was 0.7, 1.3, 0.6, and 2.1, respectively. The risk of ischemic stroke was higher in ICH with advanced WMH (adjusted HR 2.62; 95% CI 1.22-5.60) than the reference group, while the risk of hemorrhagic stroke trended higher (3.75, 0.85-16.53). The risk of MACE showed a similar pattern in ICH with advanced WMH. Among ICH patients, compared with mild WMH, the risk of ischemic stroke trended to be higher in advanced WMH (HR 3.37; 95% CI 0.90‒12.61). Advanced WMH was independently associated with an increased risk of hemorrhagic stroke (HR 33.96; 95% CI 1.52-760.95). Given the fewer rate of hemorrhagic stroke, the risk of hemorrhagic stroke might not outweigh the benefits of antiplatelet therapy for secondary prevention.",2021,"The risk of ischemic stroke was higher in ICH with advanced WMH (adjusted HR 2.62; 95% CI 1.22-5.60) than the reference group, while the risk of hemorrhagic stroke trended higher (3.75, 0.85-16.53).","['1454 noncardioembolic stroke patients with cerebral small-vessel disease, patients were categorized by presence or absence of prior ICH and WMH severity: mild-moderate WMH (reference); advanced WMH; ICH with mild-moderate WMH; and ICH with advanced WMH']",[],"['risk of ischemic stroke', 'hemorrhagic stroke', 'rate of hemorrhagic stroke', 'ischemic stroke incidence rate', 'risk of hemorrhagic stroke', 'major adverse cardiovascular events (MACE): stroke/coronary heart disease/vascular death', 'ischemic stroke and hemorrhagic stroke']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2733158', 'cui_str': 'Small vessel cerebrovascular disease'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1454.0,0.0470577,"The risk of ischemic stroke was higher in ICH with advanced WMH (adjusted HR 2.62; 95% CI 1.22-5.60) than the reference group, while the risk of hemorrhagic stroke trended higher (3.75, 0.85-16.53).","[{'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea. neurotector.jhp@gmail.com.'}, {'ForeName': 'Sun U', 'Initials': 'SU', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. sukwon@amc.seoul.kr.'}, {'ForeName': 'Hyuk Sung', 'Initials': 'HS', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung Hyuk', 'Initials': 'SH', 'LastName': 'Heo', 'Affiliation': 'Department of Neurology, Kyung Hee University Hospital, Seoul, Korea.'}]",Scientific reports,['10.1038/s41598-021-96809-3']
2562,34752255,"A randomized, 3-month, parallel-group clinical trial to compare the efficacy of electric 3-dimensional toothbrushes vs manual toothbrushes in maintaining oral health in patients with fixed orthodontic appliances.","INTRODUCTION


The aim of this single-blinded, parallel-group, randomized clinical trial was to compare the efficacy of electric 3-dimensional (3D) toothbrushes and manual toothbrushes in removing plaque and reducing gingival inflammation in orthodontic patients.
METHODS


Eighty adolescents with fixed orthodontic appliances in both arches were randomized at a 1:1 ratio, with an equal number of both sexes, in this examiner blinded, parallel clinical trial. Eligibility criteria included subjects aged between 12 and 16 years, good general health, nonextraction orthodontic treatment, and plaque-induced gingivitis, excluding patients with active caries or periodontitis, tooth agenesis, syndromes, disabilities, and craniofacial deformities, ≥2 cervical and/or proximal fillings, dental prostheses or dental implants, and subjects smoking or using antibiotics or medication predisposing to gingival enlargement. Patients were assigned to use either an electric 3D orthodontic toothbrush (Oral-B Pro-1000 with Oral-B Ortho head; Procter & Gamble, Cincinnati, Ohio) or a manual toothbrush (Oral-B Orthodontic brush; Procter & Gamble) and instructed to brush twice daily for 2 minutes. The main outcomes were: (1) plaque removal, assessed with the Modified Silness and Löe plaque index and the Modified Full Mouth Plaque Score, and (2) gingival inflammation reduction, assessed with the Modified Silness and Löe Gingival Index and the Modified Simplified Gingival Index. Measurements were taken at baseline, 1, 2, and 3 months. Randomization was achieved with 2 random sequences, one for each brush, written and sealed in opaque numbered envelopes. Blinding was possible for outcome assessment only.
RESULTS


Considerable variability was observed among patients in the values of all dependent variables. There was no difference between interventions over time for any of the outcomes, and the main effects for treatment and time were also not statistically significant. For Modified Silness and Löe plaque index, the interaction was 0.001 (95% confidence interval, -0.011 to 0.013; P = 0.89).
CONCLUSIONS


No difference in plaque removal efficacy and gingival inflammation reduction was found between the electric 3D and manual toothbrushes in adolescents with fixed orthodontic appliances. Therefore, orthodontists should focus on enhancing their patients' dental awareness and oral hygiene, along with professional prophylaxis and other oral hygiene aids, independently of the brush used.
REGISTRATION


This trial was registered at ClinicalTrials.gov (Identifier: NCT02699931).
PROTOCOL


The protocol was not published before trial commencement.
FUNDING


Electric and manual toothbrushes and toothpastes for all participants were provided by Procter & Gamble (Oral-B). Miscellaneous costs were covered by the participating departments.",2021,No difference in plaque removal efficacy and gingival inflammation reduction was found between the electric 3D and manual toothbrushes in adolescents with fixed orthodontic appliances.,"['Eighty adolescents with fixed orthodontic appliances in both arches', 'orthodontic patients', 'adolescents with fixed orthodontic appliances', 'patients with fixed orthodontic appliances', 'Eligibility criteria included subjects aged between 12 and 16\xa0years, good general health, nonextraction orthodontic treatment, and plaque-induced gingivitis, excluding patients with active caries or periodontitis, tooth agenesis, syndromes, disabilities, and craniofacial deformities, ≥2 cervical and/or proximal fillings, dental prostheses or dental implants, and subjects smoking or using antibiotics or medication predisposing to gingival enlargement']","['electric 3-dimensional (3D) toothbrushes and manual toothbrushes', 'electric 3-dimensional toothbrushes vs manual toothbrushes', 'electric 3D orthodontic toothbrush (Oral-B Pro-1000 with Oral-B Ortho head; Procter & Gamble, Cincinnati, Ohio) or a manual toothbrush (Oral-B Orthodontic brush; Procter & Gamble', 'electric 3D and manual toothbrushes']","['plaque removal efficacy and gingival inflammation reduction', 'gingival inflammation', 'plaque removal, assessed with the Modified Silness and Löe plaque index and the Modified Full Mouth Plaque Score, and (2) gingival inflammation reduction, assessed with the Modified Silness and Löe Gingival Index and the Modified Simplified Gingival Index', 'Miscellaneous costs']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0429170', 'cui_str': 'Caries active'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0000846', 'cui_str': 'Agenesis'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C3665865', 'cui_str': 'Craniofacial deformity'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0017566', 'cui_str': 'Hyperplasia of gingiva'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0205395', 'cui_str': 'Miscellaneous'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",80.0,0.308774,No difference in plaque removal efficacy and gingival inflammation reduction was found between the electric 3D and manual toothbrushes in adolescents with fixed orthodontic appliances.,"[{'ForeName': 'Ioulia-Maria', 'Initials': 'IM', 'LastName': 'Mylonopoulou', 'Affiliation': 'Department of Orthodontics, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: marilimyl@yahoo.com.'}, {'ForeName': 'Eudoxie', 'Initials': 'E', 'LastName': 'Pepelassi', 'Affiliation': 'Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Phoebus', 'Initials': 'P', 'LastName': 'Madianos', 'Affiliation': 'Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Demetrios J', 'Initials': 'DJ', 'LastName': 'Halazonetis', 'Affiliation': 'Department of Orthodontics, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2021.02.016']
2563,34752205,"PASTEC - a prospective, single-center, randomized, cross-over trial of pure physical versus physical plus attentional training in children with cancer.","Despite recent improvements in survival rates in children with cancer, long-term toxicities remain a major concern. Physical activity could reduce the impact of long-term sequelae, notably in neuropsychological and physical areas. We report of a randomized trial of pure physical versus physical/attentional training in pediatric oncology patients. Twenty-two patients aged 6-18 y.o. were included, irrespective of their clinical diagnosis or treatment status, stratified by age and randomized 1:1 into pure physical vs. physical/attentional activity arms, with a cross-over at study midpoint. Neurological, motor and neuropsychological assessments were performed at inclusion, start, crossover and end of the program. Feasibility, defined as > 80% patients attending > 80% of sessions, was the primary endpoint. Secondary outcomes were improvements in neuropsychological and motor performance tests. While 68% of patients attended more than 80% of sessions during the pre-crossover phase of the study, this dropped to 36% post-crossover. Our study therefore failed to meet our primary endpoint. Nonetheless, significant improvements in anxiety (p<0.001), emotional control (p = 0.04), organization skills (p = 0.03), as well as motor deficit scores (p = 0.04) were observed. We noted no significant difference between the pure physical and the physical/attentional training arms, or when analyzing subgroups by age or sequence of intervention. We conclude that physical activity has a positive impact on anxiety, emotional and organizational aspects as well as motor deficits. Attendance dropped during the course of the study and motivational interventions should be included in future studies or equivalent programs.Supplemental data for this article is available online at https://doi.org/10.1080/08880018.2021.1994677 .",2021,"Nonetheless, significant improvements in anxiety (p<0.001), emotional control (p = 0.04), organization skills (p = 0.03), as well as motor deficit scores (p = 0.04) were observed.","['Twenty-two patients aged 6-18 y.o. were included, irrespective of their clinical diagnosis or treatment status, stratified by age and randomized 1:1 into', 'pediatric oncology patients', 'children with cancer']","['pure physical versus physical plus attentional training', 'pure physical vs. physical/attentional activity', 'pure physical versus physical/attentional training']","['survival rates', 'organization skills', 'motor deficit scores', 'anxiety (p<0.001), emotional control', 'neuropsychological and motor performance tests', 'Neurological, motor and neuropsychological assessments']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}]",22.0,0.0358304,"Nonetheless, significant improvements in anxiety (p<0.001), emotional control (p = 0.04), organization skills (p = 0.03), as well as motor deficit scores (p = 0.04) were observed.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fontana', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Division of Pediatrics, Department ""Woman-Mother-Child"", Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Matthey', 'Affiliation': 'Centre Sport et Santé, Sports Universitaires, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Mayor', 'Affiliation': 'Neuropsychology, Pediatric Neurology and Neurorehabilitation Unit, Division of Pediatrics, Department ""Woman-Mother-Child"", Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Dufour', 'Affiliation': 'Pediatric Occupational Therapy, Division of Pediatrics, Department ""Woman-Mother-Child"", Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Destaillats', 'Affiliation': 'Clinical Research Unit, Department ""Woman-Mother-Child"", Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Ballabeni', 'Affiliation': 'Clinical Research Centre, Lausanne University Hospital and Institute of General Medicine and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Maeder', 'Affiliation': 'Centre Sport et Santé, Sports Universitaires, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Newman', 'Affiliation': 'Pediatric Neurology and Neurorehabilitation Unit, Division of Pediatrics, Department ""Woman-Mother-Child"", Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Beck Popovic', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Division of Pediatrics, Department ""Woman-Mother-Child"", Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Renella', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Division of Pediatrics, Department ""Woman-Mother-Child"", Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Diezi', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Division of Pediatrics, Department ""Woman-Mother-Child"", Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}]",Pediatric hematology and oncology,['10.1080/08880018.2021.1994677']
2564,34752494,Effect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protocol.,"BACKGROUND


Vaginal laxity is an underreported condition that negatively affects women's sexual function and their relationships. Evidence-based studies are needed to better understand this complaint and to discuss its treatment options. Thus, we present a study protocol to compare the effect of radiofrequency and pelvic floor muscle training in the treatment of women with complaints of vaginal laxity.
METHODS/DESIGN


This is a prospective, parallel-group, two-arm, randomized clinical trial (Registry: RBR-2zdvfp-REBEC). Participants will be randomly assigned to one of the two groups of intervention (Radiofrequency or Pelvic Floor Muscle Training). The study will be performed in the Urogynecology outpatient clinic and in the physiotherapy outpatient clinic at the State University of Campinas-UNICAMP and will include women aged ≥ 18 years and with self-reported complaints of vaginal laxity. Participants will be assessed at baseline (pre-intervention period) and will be followed up in two periods: first follow-up (30 days after intervention) and second follow-up (six months after intervention).
EXPECTED RESULTS


The results of this randomized clinical trial will have a positive impact on the participants' quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity.
TRIAL REGISTRATION


Registry: RBR-2zdvfp-Registro Brasileiro de Ensaios Clínicos-REBEC (19/02/2020).",2021,"The results of this randomized clinical trial will have a positive impact on the participants' quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity.
","['women with vaginal laxity', 'Urogynecology outpatient clinic and in the physiotherapy outpatient clinic at the State University of Campinas-UNICAMP and will include women aged ≥ 18 years and with self-reported complaints of vaginal laxity', 'women with complaints of vaginal laxity']","['radiofrequency and pelvic floor muscle training', 'intervention (Radiofrequency or Pelvic Floor Muscle Training']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0536154,"The results of this randomized clinical trial will have a positive impact on the participants' quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity.
","[{'ForeName': 'Gláucia Miranda Varella', 'Initials': 'GMV', 'LastName': 'Pereira', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Cássia Raquel Teatin', 'Initials': 'CRT', 'LastName': 'Juliato', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Cristiane Martins', 'Initials': 'CM', 'LastName': 'de Almeida', 'Affiliation': 'Centro de Atenção Integral à Saúde da Mulher (CAISM)-Hospital da Mulher Professor Dr. José Aristodemo Pinotti-UNICAMP, Campinas, Brazil.'}, {'ForeName': 'Kleber Cursino', 'Initials': 'KC', 'LastName': 'de Andrade', 'Affiliation': 'Centro de Atenção Integral à Saúde da Mulher (CAISM)-Hospital da Mulher Professor Dr. José Aristodemo Pinotti-UNICAMP, Campinas, Brazil.'}, {'ForeName': 'Júlia Ferreira', 'Initials': 'JF', 'LastName': 'Fante', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Martinho', 'Affiliation': 'Centro Universitário das Faculdades Associadas de Ensino-UNIFAE, São João da Boa Vista, Brazil.'}, {'ForeName': 'Rodrigo Menezes', 'Initials': 'RM', 'LastName': 'Jales', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Marcela Ponzio', 'Initials': 'MP', 'LastName': 'Pinto E Silva', 'Affiliation': 'Centro de Atenção Integral à Saúde da Mulher (CAISM)-Hospital da Mulher Professor Dr. José Aristodemo Pinotti-UNICAMP, Campinas, Brazil.'}, {'ForeName': 'Luiz Gustavo Oliveira', 'Initials': 'LGO', 'LastName': 'Brito', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil.'}]",PloS one,['10.1371/journal.pone.0259650']
2565,34752723,A randomized clinical trial of hyaluronic acid gel pulpotomy in primary molars with 1 year follow-up.,"OBJECTIVE


This randomized clinical study aimed to evaluate the success of hyaluronic acid (HA) as a pulpotomy medicament of human primary molars and to compare it with formocresol (FC) and ferric sulphate (FS) pulpotomy treatments up to 12 months.
MATERIALS AND METHODS


The study was conducted with 130 primary molars of 44 children. The ethical approval and registration to clinical trials (No: NCT04115358) were completed. After the removal of all the coronal pulp tissue, a 0.5% HA gel, or a FC, or a 20% FS solution were applied randomly to the radicular pulp tissues of the primary molars. Then, the pulp chambers were filled with a zinc oxide eugenol cement and restored either with a composite filling material or with a stainless-steel crown. The treatment success rates of the 3 groups were followed and compared clinically and radiographically at 1st-, 3rd-, 6th- and 12th-months.
RESULTS


Primary molars treated with FC, FS and HA dressings were clinically successful 77.5%, 86.8% and 87.5% respectively after 12th-month follow-up ( p  > .05). Radiographic successes of FC, FS and HA groups were lower than clinical successes (57.6%, 68.8%, 57.9% respectively at the 12th-month) but the difference between the groups was not statistically significant ( p  > .05). Equivalence analysis assuming not more than 10% difference between the materials suggested that HA was not inferior to FC or FS.
CONCLUSIONS


Within the limitations of this study, our randomized clinical trial shows that HA is a promising pulpotomy medicament in primary molars. However, further studies are justified to further improve the HA material success.",2021,"Radiographic successes of FC, FS and HA groups were lower than clinical successes (57.6%, 68.8%, 57.9% respectively at the 12th-month) but the difference between the groups was not statistically significant ( p  > .05).","['primary molars with 1 year follow-up', 'human primary molars', '130 primary molars of 44 children']","['hyaluronic acid (HA', 'zinc oxide eugenol cement and restored either with a composite filling material or with a stainless-steel crown', 'HA', 'ferric sulphate (FS) pulpotomy', 'hyaluronic acid gel pulpotomy']","['Radiographic successes', 'FC, FS and HA dressings']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0043492', 'cui_str': 'Zinc oxide eugenol dental cement'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0474702', 'cui_str': 'Sulfate measurement'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0016583', 'cui_str': 'Formocresols'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0474702', 'cui_str': 'Sulfate measurement'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]",130.0,0.0994679,"Radiographic successes of FC, FS and HA groups were lower than clinical successes (57.6%, 68.8%, 57.9% respectively at the 12th-month) but the difference between the groups was not statistically significant ( p  > .05).","[{'ForeName': 'Gökçe Çiçek', 'Initials': 'GÇ', 'LastName': 'Ildeş', 'Affiliation': 'Department of Paediatric\xa0Dentistry, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Batın Ilgıt', 'Initials': 'BI', 'LastName': 'Sezgin', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Istanbul Kent University, Istanbul, Turkey.'}, {'ForeName': 'Alexandre Rezende', 'Initials': 'AR', 'LastName': 'Vieira', 'Affiliation': 'Department of Oral and Craniofacial Sciences, School of Dental Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mentes', 'Affiliation': 'Department of Paediatric\xa0Dentistry, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2021.1998612']
2566,34752667,"A multicentre, randomised, parallel-group, double-blind, vehicle-controlled and open label versus amorolfine 5% study, to evaluate the efficacy and safety of terbinafine 10% nail lacquer in the treatment of onychomycosis.","BACKGROUND


Onychomycosis is a difficult-to-treat fungal nail infection whose treatment can involve systemic or topical antifungal approaches.
OBJECTIVES


To assess the efficacy and safety of terbinafine 10% nail lacquer in distal lateral subungual onychomycosis (DLSO).
PATIENTS/METHODS


Patients with mild-to-moderate DLSO were randomised (3:3:1) to receive double-blind topical terbinafine 10% (n = 406) or its vehicle (n = 410) administered once daily for 4 weeks and then once weekly for 44 weeks, or open-label topical amorolfine 5% (n = 137) for 48 weeks, with a 12-week follow-up period. The primary efficacy endpoint, complete cure rate at Week 60, was a composite of negative potassium hydroxide (KOH) microscopy, negative culture for dermatophytes and no residual clinical involvement of the target big toenail.
RESULTS


Complete cure rates at Week 60 in the terbinafine, vehicle and amorolfine groups were 5.67%, 2.20% and 2.92%, respectively (odds ratio (OR) vs vehicle = 2.68; 95% confidence intervals (CI): 1.22-5.86; p = .0138). Statistically significant differences in responder (negative KOH and negative culture and ≤10% residual clinical involvement) and mycological cure rates (negative KOH and negative culture) at Week 60 were obtained between terbinafine and vehicle. Terbinafine was well-tolerated with no systemic adverse reactions identified; the most common topical adverse reactions were erythema and skin irritation.
CONCLUSIONS


Terbinafine 10% nail lacquer was an effective treatment for mild-to-moderate onychomycosis improving both clinical and mycological criteria compared with vehicle. Furthermore, there may be some benefits compared to the currently available topical agent, amorolfine 5%. Treatment was well-tolerated and safe.",2021,"RESULTS


Complete cure rates at Week 60 in the terbinafine, vehicle and amorolfine groups were 5.67%, 2.20% and 2.92%, respectively (odds ratio (OR) vs vehicle = 2.68; 95% confidence intervals (CI): 1.22-5.86; p = .0138).","['Patients with mild-to-moderate DLSO', 'onychomycosis', 'distal lateral subungual onychomycosis (DLSO']","['vehicle-controlled and open label versus amorolfine', 'terbinafine', 'double-blind topical terbinafine', 'Terbinafine', 'open-label topical amorolfine']","['responder (negative KOH and negative culture and ≤10% residual clinical involvement) and mycological cure rates (negative KOH and negative culture', 'negative potassium hydroxide (KOH) microscopy, negative culture for dermatophytes and no residual clinical involvement of the target big toenail', 'tolerated and safe', 'Complete cure rates', 'efficacy and safety', 'complete cure rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}]","[{'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0051736', 'cui_str': 'Amorolfine'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0011635', 'cui_str': 'Arthrodermataceae'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.498455,"RESULTS


Complete cure rates at Week 60 in the terbinafine, vehicle and amorolfine groups were 5.67%, 2.20% and 2.92%, respectively (odds ratio (OR) vs vehicle = 2.68; 95% confidence intervals (CI): 1.22-5.86; p = .0138).","[{'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Blume-Peytavi', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Tosti', 'Affiliation': 'Department of Dermatology and Cutaneous Surgery, Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery, University of Miami, FL, USA.'}, {'ForeName': 'Meritxell', 'Initials': 'M', 'LastName': 'Falqués', 'Affiliation': 'Almirall Research and Development Center, Sant Feliu de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Tamarit', 'Affiliation': 'Almirall Research and Development Center, Sant Feliu de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Carreño', 'Affiliation': 'Almirall Research and Development Center, Sant Feliu de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Galván', 'Affiliation': 'Almirall Global Medical Affairs Department, Barcelona, Spain.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tebbs', 'Affiliation': 'Island View Consulting Ltd., Dronfield, United Kingdom.'}]",Mycoses,['10.1111/myc.13392']
2567,34752649,Why do we hunger for touch? The impact of daily gentle touch stimulation on maternal-infant physiological and behavioral regulation and resilience.,"We report the impact of a Gentle Touch Stimulation (GTS) program. Forty-three mothers provided daily 10-min GTS with C-tactile (CT) afferent optimal stroking touch, for 4 weeks to their 3-12 weeks old infants. CT-afferents are cutaneous unmyelinated, low-threshold mechanosensitive nerves hypothesized to underly the regulatory impact of affective touch. We compared physiological and behavioral responses during a no-touch-baseline (BL), static-touch-baseline (BL-T), intervention/control (GTS/CTRL), Still Face (SF) and Reunion (RU) condition for GTS-infants versus a control-group (CTRL) at the start (T1) and end of (T2) of the program. We collected mother-infant ECG, respiration, cortisol, video-recordings, and diary-reports. At T1, physiological arousal significantly increased during SF in both groups, that is, decreased respiratory sinus arrhythmia (RSA) and R-R interval (RRI). At T2, GTS-infants showed significantly increased RSA, RRI, decreased respiration during GTS, buffering SF-arousal and allowing complete recovery during RU; CTRL-infants showed higher SF-arousal and small recovery, under initial BL-levels. Maternal cardio-respiratory showed a metabolic investment during RU. Cortisol and behavioral analyses showed higher arousal in CTRL-infants than GTS-infants at T2. We suggest that the combination of phasic short-term and tonic long-term responses to CT-optimal stroking touch, delivered in a structured daily manner, contribute to the building of infant stress regulation and resilience.",2021,"At T2, GTS-infants showed significantly increased RSA, RRI, decreased respiration during GTS, buffering SF-arousal and allowing complete recovery during RU; CTRL-infants showed higher SF-arousal and small recovery, under initial BL-levels.",[],"['daily 10-min GTS with C-tactile (CT) afferent optimal stroking touch', 'Gentle Touch Stimulation (GTS) program', 'daily gentle touch stimulation', 'GTS-infants versus a control-group (CTRL']","['RSA, RRI, decreased respiration during GTS, buffering SF-arousal', 'respiratory sinus arrhythmia (RSA) and R-R interval (RRI', 'physiological arousal', 'SF-arousal and small recovery, under initial BL-levels', 'maternal-infant physiological and behavioral regulation and resilience', 'static-touch-baseline (BL-T), intervention/control (GTS/CTRL), Still Face (SF) and Reunion (RU) condition']",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035373', 'cui_str': 'Reunion'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",43.0,0.0438445,"At T2, GTS-infants showed significantly increased RSA, RRI, decreased respiration during GTS, buffering SF-arousal and allowing complete recovery during RU; CTRL-infants showed higher SF-arousal and small recovery, under initial BL-levels.","[{'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Van Puyvelde', 'Affiliation': 'VIPER Research Unit, LIFE Department, Royal Military Academy, Brussels, Belgium.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Staring', 'Affiliation': 'Experimental and Applied Psychology, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Schaffers', 'Affiliation': 'Experimental and Applied Psychology, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rivas-Smits', 'Affiliation': 'Experimental and Applied Psychology, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Leysa', 'Initials': 'L', 'LastName': 'Groenendijk', 'Affiliation': 'Experimental and Applied Psychology, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Smeyers', 'Affiliation': 'Experimental and Applied Psychology, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Collette', 'Affiliation': 'Clinical & Lifespan Psychology, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Schoofs', 'Affiliation': 'Experimental and Applied Psychology, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Van den Bossche', 'Affiliation': 'Experimental and Applied Psychology, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'McGlone', 'Affiliation': 'School of Natural Sciences & Psychology, Faculty of Science, Liverpool John Moores University, Liverpool, UK.'}]",Infant mental health journal,['10.1002/imhj.21949']
2568,34752573,Impact of Electronic Medication Reminder Caps on Patient Adherence and Blood Pressure.,"Background:  Medication adherence is widely recognized as an essential component of chronic disease management, yet only 50% of patients take their medication as prescribed. Newer technologies have the potential to improve medication adherence.  Objective:  To conduct a pilot study estimating the impact of a pharmacy-dispensed electronic reminder cap (SMARxT cap), which also records cap openings, on medication adherence and blood pressure (BP).  Methods:  After a 30-day run-in period, 28 individuals were randomized to receive a SMARxT or placebo cap on each BP medication. The primary outcome was adherence measured via (1) the medication possession ratio, (2) number of cap openings, and (3) self-report. The secondary outcome was the average of 2 BP readings at 6 months. Mean changes from baseline to 6 months were compared between the 2 groups.  Results:  The medication possession ratio increased 2.7% in the SMARxT cap group and decreased 1.1% in the control group ( P  = .13), and cap openings increased 11.9% in the SMARxT cap group and 9.9% in the control group ( P  = .83). Self-reported adherence increased 1.1 points in the SMARxT cap group and 0.8 points in the control group ( P  = .64). Systolic BP decreased 8.2 mm Hg in the SMARxT cap group and 2.8 mm Hg in the placebo cap group ( P  = .35), and diastolic BP decreased to 6.2 mm Hg in the SMARxT cap group and was unchanged in the placebo cap group ( P  = .06).  Conclusions:  Use of SMARxT cap showed nonsignificant improvement in medication adherence and BP lowering. This technology has potential to characterize and improve medication-taking behavior.",2021,Self-reported adherence increased 1.1 points in the SMARxT cap group and 0.8 points in the control group ( P  = .64).,['28 individuals'],"['SMARxT', 'pharmacy-dispensed electronic reminder cap (SMARxT cap', 'SMARxT or placebo']","['Self-reported adherence', 'medication possession ratio', 'medication adherence and blood pressure (BP', 'average of 2 BP readings', 'diastolic BP', 'medication adherence and BP lowering', 'adherence measured via (1) the medication possession ratio, (2) number of cap openings, and (3) self-report', 'cap openings', 'Patient Adherence and Blood Pressure', 'Systolic BP']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0754977', 'cui_str': '2-(125I)N-(N-benzylpiperidin-4-yl)-4-iodobenzamide'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",28.0,0.118439,Self-reported adherence increased 1.1 points in the SMARxT cap group and 0.8 points in the control group ( P  = .64).,"[{'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Mehas', 'Affiliation': 'National Quality Forum, Washington, DC, USA.'}, {'ForeName': 'Karen Suchanek', 'Initials': 'KS', 'LastName': 'Hudmon', 'Affiliation': 'Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jaynes', 'Affiliation': 'Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Klink', 'Affiliation': 'Concordance Health Solutions, West Lafayette, IN, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Downey', 'Affiliation': 'Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Zillich', 'Affiliation': 'Purdue University, West Lafayette, IN, USA.'}]",The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians,['10.1177/87551225211018708']
2569,34752990,Effectiveness of an intervention to reduce stigma towards people with a severe mental disorder diagnosis in primary health care personnel: Programme Igual-Mente.,"This study assessed the effectiveness of a program (called Igual-Mente, Equal-Mind) designed to reduce stigma in primary health care personnel. A random clinical trial was performed (ISRCTN46464036). There were 316 primary care professionals and technicians who were randomized and assigned to the experimental or control group. The program considered as strategies the education, the contact and the development of skills. There were six sessions with the primary care staff and two sessions with the managers of the health centers. It was executed by two facilitators, a professional psychologist and an expert by experience, i.e., a person diagnosed with a severe mental disorder (SMD). Attitudes, social distance, and humane treatment behaviors toward people with SMD were assessed. The intervention was effective in reducing stigma attitudes y social distance towards people diagnosed with SMD. The magnitude of the changes ranged from moderate to high in all these variables and the effects were maintained for four months after the end of the program. Regarding humane treatment behaviors, the effects were less clear. This study shows good results indicating that well-designed interventions can effectively reduce stigma towards people diagnosed with SMD, which is one of the main challenges of health systems.",2021,The magnitude of the changes ranged from moderate to high in all these variables and the effects were maintained for four months after the end of the program.,"['316 primary care professionals and technicians', 'stigma towards people with a severe mental disorder diagnosis in primary health care personnel', 'person diagnosed with a severe mental disorder (SMD', 'primary health care personnel']","['program (called Igual-Mente, Equal-Mind']","['stigma attitudes y social distance', 'Attitudes, social distance, and humane treatment behaviors toward people with SMD']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}]",316.0,0.00993493,The magnitude of the changes ranged from moderate to high in all these variables and the effects were maintained for four months after the end of the program.,"[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Grandón', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile. Electronic address: pgrandon@udec.cl.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Saldivia', 'Affiliation': 'Psychiatric Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Cova', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bustos', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Vaccari', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Ramírez-Vielma', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Vielma-Aguilera', 'Affiliation': 'Psychiatric Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zambrano', 'Affiliation': 'Recovery Group, Concepcion, Chile.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Ortiz', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Knaak', 'Affiliation': 'Social Sciences Department, University of Calgary, Calgary, Canada.'}]",Psychiatry research,['10.1016/j.psychres.2021.114259']
2570,34752971,Handgrip as a measure of muscle strength and its physiological dependence on therapeutic variables: A randomized case.,"Clinical and medical data findings have traditionally been more representative of male than female subjects, and when combined, have not clearly differentiated between the groups. In this study there were no research questions initially contemplated, as the data were obtained from an educational setting, where participants completed tasks as part of a pedagogical program of preparation. The nature of the post-hoc analysis renders the study as a hypothesis-generating type rather than a hypothesis-testing one. It began as a cross-sectional quantitative analysis of performance on a task to explore the relationship between hand grip and three independent physiological variables. The data collected from all subjects were randomized since the total group of participants contained a disproportionate number of females as compared to males, this being a result of a demographic predominance of female students in a program of teacher preparation. Graphical analysis with the slope taken as a measure of hand grip dependence on three independent variables, and the correlation value used as a measure of association between variables yielded discernible differences. The grip strength dependence on the hand size as well as the wrist thickness show consistently significant differences for females only, with t test of significance (p < .001), and large effect size differences based on Cohen's d values of 3.08 and 1.92, respectively. The significance of the finding that female grip strength depends the most on wrist thickness has implications for rehabilitative and therapeutic settings.",2021,"The grip strength dependence on the hand size as well as the wrist thickness show consistently significant differences for females only, with t test of significance (p < .001), and large effect size differences based on Cohen's d values of 3.08 and 1.92, respectively.",['female students in a program of teacher preparation'],[],['grip strength dependence'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",[],"[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}]",,0.0371074,"The grip strength dependence on the hand size as well as the wrist thickness show consistently significant differences for females only, with t test of significance (p < .001), and large effect size differences based on Cohen's d values of 3.08 and 1.92, respectively.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Espinoza', 'Affiliation': 'Departments of Adolescence Education and Chemistry-Physics, State University of New York-College at Old Westbury, P.O. Box 210, Old Westbury, NY 11568, USA. Electronic address: espinozaf@oldwestbury.edu.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Wheeler', 'Affiliation': 'Pre-Medical Program, Stony Brook University, 100 Nichols Road, Stony Brook, NY, 11794 USA.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2021.11.001']
2571,34752941,Is one or two infusions better in the first week of low-dose ketamine treatment for medication-resistant depression? A post hoc pooled analysis of randomized placebo-controlled and open-label trials.,"BACKGROUND


Whether a second ketamine infusion in the first week improves the antidepressant, antisuicidal, and anti-inflammatory effects of the first low-dose ketamine infusion remains unclear.
METHODS


A total of 78 patients with medication-resistant depression were allocated to receive two ketamine infusions (n = 30; days 1 and 4), a single ketamine infusion (n = 24; only day 1), or normal saline placebo infusion (n = 24; only day 1). The Montgomery-Asberg Depression Scale (MADRS) and 17-item Hamilton Rating Scale for Depression (HDRS) were administered before and at 40 min, 240 min, day 2, day 4, day 5, and day 7 after infusion. Serum concentrations of interleukin (IL)-2 and tumor necrosis factor (TNF)-α were assessed.
RESULTS


Two ketamine infusions improved the overall depressive symptoms (p < 0.001) and melancholic symptoms (p < 0.001) than a single ketamine or placebo infusion. The antisuicidal effect did not differ between the ketamine treatment groups. Two ketamine infusions increased TNF-α levels compared with a single ketamine or placebo infusion (p = 0.015). A single ketamine infusion improved the TNF-α-to-IL-2 ratio, an index of average anti-inflammatory effect, than two ketamine infusions or a single placebo infusion (p = 0.027).
DISCUSSION


Repeated low-dose ketamine infusions improved the antidepressant effect, but not the antisuicidal effect, compared with a single infusion. However, repeated ketamine infusions may exert a lesser anti-inflammatory effect than a single infusion.",2021,Two ketamine infusions increased TNF-α levels compared with a single ketamine or placebo infusion (p = 0.015).,['78 patients with medication-resistant depression'],"['ketamine infusions', 'placebo', 'ketamine or placebo', 'ketamine infusion', 'ketamine', 'normal saline placebo infusion']","['antisuicidal effect', 'TNF-α-to-IL-2 ratio, an index of average anti-inflammatory effect', 'antidepressant effect', 'TNF-α levels', 'Montgomery-Asberg Depression Scale (MADRS) and 17-item Hamilton Rating Scale for Depression (HDRS', 'melancholic symptoms', 'overall depressive symptoms', 'Serum concentrations of interleukin (IL)-2 and tumor necrosis factor (TNF)-α']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",78.0,0.277891,Two ketamine infusions increased TNF-α levels compared with a single ketamine or placebo infusion (p = 0.015).,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan. Electronic address: kremer7119@gmail.com.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Medical Research, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chung', 'Initials': 'WC', 'LastName': 'Mao', 'Affiliation': 'Department of Psychiatry, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Medical Research, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Psychiatry, Cheng Hsin General Hospital, Taipei, Taiwan. Electronic address: tomsu0402@gmail.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.11.006']
2572,34752934,Accelerated intermittent theta-burst stimulation broadly ameliorates symptoms and cognition in Alzheimer's disease: A randomized controlled trial.,"BACKGROUND


Deficits in associative memory (AM) are the earliest and most prominent feature of Alzheimer's disease (AD) and demonstrate a clear cause of distress for patients and their families.
OBJECTIVE


The present study aimed to determine AM enhancements following accelerated intermittent theta-burst stimulation (iTBS) in patients with AD.
METHODS


In a randomized, double-blind, sham-controlled design, iTBS was administered to the left dorsolateral prefrontal cortex (DLPFC) of patients with AD for 14 days. Measurements included AM (primary outcome) and a comprehensive neuropsychological battery. Patients were evaluated at baseline, following the intervention (week 2), and 8 weeks after treatment cessation (week 10).
RESULTS


Sixty patients with AD were initially enrolled; 47 completed the trial. The active group displayed greater AM improvements compared with the sham group at week 2 (P = 0.003), which was sustained at week 10. Furthermore, higher Mini-Mental State Examination (MMSE) scores at baseline were associated with greater AM improvements at weeks 2 and 10. For the independent iTBS group, this correlation predicted improvements in AM (P < 0.001) and identified treatment responders with 92% accuracy. Most of the neuropsychological tests were markedly improved in the active group. In particular, the Montreal Cognitive Assessment and MMSE in the active group increased by 2.8 and 2.3 points, respectively, at week 2, while there was no marked change in the sham group.
CONCLUSION


In the present study, accelerated iTBS of the DLPFC demonstrated an effective and well-tolerated complementary treatment for patients with AD, especially for individuals with relatively high MMSE scores.",2021,"The active group displayed greater AM improvements compared with the sham group at week 2 (P = 0.003), which was sustained at week 10.","['patients with AD', 'Sixty patients with AD were initially enrolled; 47 completed the trial', 'patients with AD, especially for individuals with relatively high MMSE scores', ""Alzheimer's disease""]","['Accelerated intermittent theta-burst stimulation', 'accelerated intermittent theta-burst stimulation (iTBS', 'iTBS']","['AM', 'Montreal Cognitive Assessment and MMSE', 'comprehensive neuropsychological battery', 'higher Mini-Mental State Examination (MMSE) scores', 'AM improvements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0451331', 'cui_str': 'Neuropsychological battery'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.599897,"The active group displayed greater AM improvements compared with the sham group at week 2 (P = 0.003), which was sustained at week 10.","[{'ForeName': 'Xingqi', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China; Collaborative Innovation Center of Neuropsychiatric Disorders and Mental Health, Hefei, 230022, China.'}, {'ForeName': 'Gong-Jun', 'Initials': 'GJ', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China; Collaborative Innovation Center of Neuropsychiatric Disorders and Mental Health, Hefei, 230022, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': ""Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China; Collaborative Innovation Center of Neuropsychiatric Disorders and Mental Health, Hefei, 230022, China; Department of Neurology, Second People's Hospital of Hefei City, The Hefei Affiliated Hospital of Anhui Medical University, Hefei, 230022, China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China; Collaborative Innovation Center of Neuropsychiatric Disorders and Mental Health, Hefei, 230022, China.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China.'}, {'ForeName': 'Guixian', 'Initials': 'G', 'LastName': 'Xiao', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China; Collaborative Innovation Center of Neuropsychiatric Disorders and Mental Health, Hefei, 230022, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China; Collaborative Innovation Center of Neuropsychiatric Disorders and Mental Health, Hefei, 230022, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China; Collaborative Innovation Center of Neuropsychiatric Disorders and Mental Health, Hefei, 230022, China. Electronic address: ahykdxwl@126.com.'}, {'ForeName': 'Yanghua', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Institute of Artificial Intelligence, Hefei Comprehensive National Science Center, Hefei, 230088, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China; Collaborative Innovation Center of Neuropsychiatric Disorders and Mental Health, Hefei, 230022, China. Electronic address: ayfytyh@126.com.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, the School of Mental Health and Psychological Sciences, Anhui MedicalUniversity, Hefei, 230032, China; Institute of Artificial Intelligence, Hefei Comprehensive National Science Center, Hefei, 230088, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, 230022, China; Collaborative Innovation Center of Neuropsychiatric Disorders and Mental Health, Hefei, 230022, China; Anhui Provincial Institute of Translational Medicine, Anhui Medical University, Hefei, 230032, China. Electronic address: wangkai1964@126.com.'}]",Brain stimulation,['10.1016/j.brs.2021.11.007']
2573,34752902,Magnetically-controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-induced Gastrointestinal Injury.,"BACKGROUND


Gastrointestinal bleeding is the most frequent major complication of antiplatelet therapy. In patients at low bleeding risk, however, clinically overt gastrointestinal bleeding is relatively uncommon.
OBJECTIVE


We sought to assess the effects of different antiplatelet regimens on gastrointestinal mucosal injury using a novel magnetically-controlled capsule endoscopy system in patients at low bleeding risk.
METHODS


Patients (n=505) undergoing percutaneous coronary intervention in whom capsule endoscopy demonstrated no ulcerations or bleeding (although erosions were permitted) after 6 months of dual antiplatelet therapy (DAPT) were randomly assigned to aspirin plus placebo (n=168), clopidogrel plus placebo (n=169), or aspirin plus clopidogrel (n=168) for an additional 6 months. The primary endpoint was the incidence of gastrointestinal mucosal injury (erosions, ulceration, or bleeding) at 6-month or 12-month capsule endoscopy.
RESULTS


Gastrointestinal mucosal injury through 12 months was less with single antiplatelet therapy (SAPT) compared with DAPT (94.3% vs. 99.2%, P=0.02). Aspirin and clopidogrel monotherapy had similar effects. Among 68 patients without any gastrointestinal injury at randomization (including no erosions), SAPT compared with DAPT caused less gastrointestinal injury (68.1% vs. 95.2%, P=0.006), including fewer new ulcers (8.5% vs. 38.1%, P=0.009). Clinical gastrointestinal bleeding between 6 and 12 months was less with SAPT compared with DAPT (0.6% vs. 5.4%, P=0.001).
CONCLUSIONS


Despite being at low risk of bleeding, nearly all patients receiving antiplatelet therapy developed gastrointestinal injury, although overt bleeding was infrequent. DAPT for 6 months followed by SAPT with aspirin or clopidogrel between 6 and 12 months resulted in less gastrointestinal mucosal injury and clinical bleeding compared with DAPT through 12 months.",2021,"Among 68 patients without any gastrointestinal injury at randomization (including no erosions), SAPT compared with DAPT caused less gastrointestinal injury (68.1% vs. 95.2%, P=0.006), including fewer new ulcers (8.5% vs. 38.1%, P=0.009).","['Patients (n=505) undergoing percutaneous coronary intervention in whom capsule endoscopy demonstrated no ulcerations or bleeding (although erosions were permitted) after 6 months of dual antiplatelet therapy (DAPT', 'patients at low bleeding risk', '68 patients without any gastrointestinal injury at randomization (including no erosions), SAPT compared with']","['novel magnetically-controlled capsule endoscopy system', 'SAPT', 'aspirin plus clopidogrel', 'aspirin plus placebo', 'DAPT', 'SAPT with aspirin or clopidogrel', 'Aspirin and clopidogrel monotherapy', 'Magnetically-controlled Capsule Endoscopy', 'clopidogrel plus placebo']","['Clinical gastrointestinal bleeding', 'gastrointestinal injury', 'incidence of gastrointestinal mucosal injury (erosions, ulceration, or bleeding) at 6-month or 12-month capsule endoscopy', 'overt bleeding', 'new ulcers', 'gastrointestinal mucosal injury and clinical bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0160345', 'cui_str': 'Injury of gastrointestinal tract'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0160345', 'cui_str': 'Injury of gastrointestinal tract'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0205314', 'cui_str': 'New'}]",505.0,0.0536317,"Among 68 patients without any gastrointestinal injury at randomization (including no erosions), SAPT compared with DAPT caused less gastrointestinal injury (68.1% vs. 95.2%, P=0.006), including fewer new ulcers (8.5% vs. 38.1%, P=0.009).","[{'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Changhai Hospital of Navy Military Medical University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xianxian', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Changhai Hospital of Navy Military Medical University, Shanghai, China.'}, {'ForeName': 'Shuren', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Miaohan', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': ""The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jinhai', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Qu', 'Affiliation': 'The Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Chunmeng', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'The Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Shaobin', 'Initials': 'S', 'LastName': 'Jia', 'Affiliation': 'General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Shaoqi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Leisheng', 'Initials': 'L', 'LastName': 'Ru', 'Affiliation': 'No. 980 Hospital of Joint Logistic Support Force, Shijiazhuang, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'No. 980 Hospital of Joint Logistic Support Force, Shijiazhuang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': ""Xijing Hospital of Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Xijing Hospital of Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'General Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Bangmao', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'General Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Youlin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Junxia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Seventh Medical Center of the General Hospital of PLA, Beijing, China.'}, {'ForeName': 'Jiangqiu', 'Initials': 'J', 'LastName': 'Sheng', 'Affiliation': 'Seventh Medical Center of the General Hospital of PLA, Beijing, China.'}, {'ForeName': 'Yitong', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cui', 'Affiliation': 'The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhaoshen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Changhai Hospital of Navy Military Medical University, Shanghai, China. Electronic address: zhsl@vip.163.com.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Mount Sinai Heart and the Cardiovascular Research Foundation, New York, NY, USA.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.10.028']
2574,34753201,Perioperative systemic nonsteroidal anti-inflammatory drugs (NSAIDs) in women undergoing breast surgery.,"BACKGROUND


Breast surgery encompasses oncologic, reconstructive, and cosmetic procedures. With the recent focus on the over-prescribing of opioids in the literature, it is important to assess the effectiveness and safety of non-opioid pain medication regimens including nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID pain medications. Clinicians have differing opinions on the safety of perioperative (relating to, occurring in, or being the period around the time of a surgical operation) NSAIDs for breast surgery given the unclear risk/benefit ratio. NSAIDs have been shown to decrease inflammation, pain, and fever, while potentially increasing the risks of bleeding complications.
OBJECTIVES


To assess the effects of perioperative NSAID use versus non-NSAID analgesics (other pain medications) in women undergoing any form of breast surgery.
SEARCH METHODS


The Cochrane Breast Information Specialist searched the Cochrane Breast Cancer Group (CBCG) Specialized Register, CENTRAL (the Cochrane Library), MEDLINE, Embase, The WHO International Clinical Trials Registry Platform (ICTRP) and Clinicaltrials.gov registries to 21 September 2020. Full articles were retrieved for potentially eligible trials.
SELECTION CRITERIA


We considered all randomized controlled trials (RCTs) looking at perioperative NSAID use in women undergoing breast surgery.
DATA COLLECTION AND ANALYSIS


Two review authors independently screened studies, extracted data and assessed risk of bias, and certainty of the evidence using the GRADE approach. The main outcomes were incidence of breast hematoma within 90 days (requiring reoperation, interventional drainage, or no treatment) of breast surgery and pain intensity 24 hours following surgery, incidence rate or severity of postoperative nausea, vomiting or both, bleeding from any location within 90 days, need for blood transfusion, other side effects of NSAID use, opioid use within 24 hours of surgery, length of hospital stay, breast cancer recurrence, and non-prescribed NSAID use. Data were presented as risk ratios (RRs) for dichotomous outcomes and standardized mean differences (SMDs) for continuous outcomes.
MAIN RESULTS


We included 12 RCTs with a total of 1596 participants. Seven studies compared NSAIDs (ketorolac, diclofenac, flurbiprofen, parecoxib and celecoxib) to placebo. Four studies compared NSAIDs (ketorolac, flurbiprofen, ibuprofen, and celecoxib) to other analgesics (morphine, hydrocodone, hydromorphone, fentanyl). One study compared NSAIDs (diclofenac) to no intervention. NSAIDs compared to placebo Most outcomes are judged to have low-certainty evidence unless stated otherwise. There may be little to no difference in the incidence of breast hematomas within 90 days of breast surgery (RR 0.33, 95% confidence interval (CI) 0.05 to 2.02; 2 studies, 230 participants; I 2  = 0%). NSAIDs may reduce pain intensity 24 (± 12) hours following surgery compared to placebo (SMD -0.26, 95% CI -0.49 to -0.03; 3 studies, 310 participants; I 2  = 73%). There may be little to no difference in the incidence rates or severities of postoperative nausea, vomiting, or both (RR 1.15, 95% CI 0.58 to 2.27; 4 studies, 939 participants; I 2  = 81%), bleeding from any location within 90 days (RR 1.05, 95% CI 0.89 to 1.24; 2 studies, 251 participants; I 2  = 8%), or need for blood transfusion compared to placebo groups, but we are very uncertain (RR 4.62, 95% CI 0.23 to 91.34; 1 study, 48 participants; very low-certainty evidence). There may be no difference in other side effects (RR 1.12, 95% CI 0.44 to 2.86; 2 studies, 251 participants; I 2  = 0%). NSAIDs may reduce opioid use within 24 hours of surgery compared to placebo (SMD -0.45, 95% CI -0.85 to -0.05; 4 studies, 304 participants; I 2  = 63%). NSAIDs compared to other analgesics There is little to no difference in the incidence of breast hematomas within 90 days of breast surgery, but we are very uncertain (RR 0.33, 95% CI 0.01 to 7.99; 1 study, 100 participants; very low-certainty evidence). NSAIDs may reduce pain intensity 24 (± 12) hours following surgery (SMD -0.68, 95% CI -0.97 to -0.39; 3 studies, 200 participants; I 2  = 89%; low-certainty evidence) and probably reduce the incidence rates or severities of postoperative nausea, vomiting, or both compared to other analgesics (RR 0.18, 95% CI 0.06 to 0.57; 3 studies, 128 participants; I 2  = 0%; moderate-certainty evidence). There is little to no difference in the development of bleeding from any location within 90 days of breast surgery or in other side effects, but we are very uncertain (bleeding: RR 0.33, 95% CI 0.01 to 7.99; 1 study, 100 participants; other side effects: RR 0.11, 95% CI 0.01 to 1.80; 1 study, 48 participants; very low-certainty evidence). NSAIDs may reduce opioid use within 24 hours of surgery compared to other analgesics (SMD -6.87, 95% CI -10.93 to -2.81; 3 studies, 178 participants; I 2  = 96%; low-certainty evidence). NSAIDs compared to no intervention There is little to no difference in pain intensity 24 (± 12) hours following surgery compared to no intervention, but we are very uncertain (SMD -0.54, 95% CI -1.09 to 0.00; 1 study, 60 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS


Low-certainty evidence suggests that NSAIDs may reduce postoperative pain, nausea and vomiting, and postoperative opioid use. However, there was very little evidence to indicate whether NSAIDs affect the rate of breast hematoma or bleeding from any location within 90 days of breast surgery, the need for blood transfusion and incidence of other side effects compared to placebo or other analgesics. High-quality large-scale RCTs are required before definitive conclusions can be made.",2021,"NSAIDs may reduce pain intensity 24 (± 12) hours following surgery compared to placebo (SMD -0.26, 95% CI -0.49 to -0.03; 3 studies, 310 participants; I 2  = 73%).","['women undergoing breast surgery', 'women undergoing any form of breast surgery', '12 RCTs with a total of 1596 participants']","['NSAIDs (ketorolac, flurbiprofen, ibuprofen, and celecoxib', 'perioperative NSAID use versus non-NSAID analgesics (other pain medications', 'NSAIDs (ketorolac, diclofenac, flurbiprofen, parecoxib and celecoxib', 'Cochrane Breast Cancer Group (CBCG', 'analgesics (morphine, hydrocodone, hydromorphone, fentanyl', 'NSAIDs (diclofenac', 'Perioperative systemic nonsteroidal anti-inflammatory drugs (NSAIDs', 'placebo']","['incidence of breast hematomas', 'bleeding', 'side effects', 'blood transfusion', 'incidence of breast hematoma within 90 days (requiring reoperation, interventional drainage, or no treatment) of breast surgery and pain intensity 24 hours following surgery, incidence rate or severity of postoperative nausea, vomiting or both, bleeding from any location within 90 days, need for blood transfusion, other side effects of NSAID use, opioid use within 24 hours of surgery, length of hospital stay, breast cancer recurrence, and non-prescribed NSAID use', 'inflammation, pain, and fever', 'incidence rates or severities of postoperative nausea, vomiting', 'pain intensity', 'rate of breast hematoma or bleeding', 'postoperative pain, nausea and vomiting, and postoperative opioid use']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C1286083', 'cui_str': 'Form of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0016377', 'cui_str': 'Flurbiprofen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0342095', 'cui_str': 'Breast hematoma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",48.0,0.605765,"NSAIDs may reduce pain intensity 24 (± 12) hours following surgery compared to placebo (SMD -0.26, 95% CI -0.49 to -0.03; 3 studies, 310 participants; I 2  = 73%).","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Klifto', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Missouri School of Medicine, Columbia, USA.'}, {'ForeName': 'Ala', 'Initials': 'A', 'LastName': 'Elhelali', 'Affiliation': 'School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Rachael M', 'Initials': 'RM', 'LastName': 'Payne', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Washington University School of Medicine, St Louis, USA.'}, {'ForeName': 'Carisa M', 'Initials': 'CM', 'LastName': 'Cooney', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine, Baltimore, USA.'}, {'ForeName': 'Michele A', 'Initials': 'MA', 'LastName': 'Manahan', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine, Baltimore, USA.'}, {'ForeName': 'Gedge D', 'Initials': 'GD', 'LastName': 'Rosson', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine, Baltimore, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013290.pub2']
2575,34753185,Association between hypertensive disorders of pregnancy and long-term neurodevelopmental outcomes in the offspring.,"OBJECTIVE


The long-term impact of hypertensive disorders of pregnancy (HDP) exposure on offspring health is an emerging research area. The objective of this study was to evaluate the association between a maternal diagnosis of HDP (gestational hypertension and preeclampsia) and adverse neurodevelopmental outcomes in the offspring.
STUDY DESIGN


A secondary analysis of two parallel multicenter clinical trials of thyroxine therapy for subclinical hypothyroid disorders in pregnancy. Women with singleton non-anomalous gestations diagnosed with subclinical hypothyroidism or hypothyroxinemia were randomized to thyroxine therapy or placebo. The primary outcome was child intelligence quotient (IQ) at 5 years of age. Secondary outcomes were Bayley-III cognitive, motor and language scores at 12 and 24 months, DAS-II scores at 36 months, the Conners' Rating Scales-Revised at 48 months, and scores from the Child Behavior Checklist at 36 and 60 months. Associations between neurodevelopment outcomes and maternal HDP were examined using univariable and multivariable analyses.
RESULTS


A total of 112 woman-child dyads with HDP were compared with 1067 woman-child dyads without HDP. In univariable analysis, mean maternal age (26.7±5.9 vs. 27.8±5.7 years, p=0.032) and nulliparity (45.5% vs. 31.0%, p=0.002) differed significantly between the two groups. Maternal socioeconomic characteristics did not differ between the groups. After adjusting for potential confounders, there were no significant differences in primary or secondary neurodevelopment outcome between offspring exposed to HDP and those unexposed. However, when dichotomized as low or high scores, we found higher rates of language delay (language scores <85: -1 standard deviation) at two years of age among offspring exposed to HDP compared with those unexposed (46.5% versus 30.5%, adjusted odds ratio 2.22, 95% CI 1.44 - 3.42).
CONCLUSIONS


In this cohort of pregnant women, HDP diagnosis was associated with language delay at 2 years of age. However, other long-term neurodevelopmental outcomes in offspring were not associated with HDP.",2021,"After adjusting for potential confounders, there were no significant differences in primary or secondary neurodevelopment outcome between offspring exposed to HDP and those unexposed.","['Women with singleton non-anomalous gestations diagnosed with subclinical hypothyroidism or hypothyroxinemia', 'subclinical hypothyroid disorders in pregnancy', '112 woman-child dyads with HDP were compared with 1067 woman-child dyads without HDP', 'pregnant women, HDP diagnosis was associated with language delay at 2 years of age', 'hypertensive disorders of pregnancy (HDP) exposure on offspring health']","['thyroxine therapy', 'thyroxine therapy or placebo']","['child intelligence quotient (IQ', 'nulliparity', 'maternal diagnosis of HDP (gestational hypertension and preeclampsia) and adverse neurodevelopmental outcomes', ""Bayley-III cognitive, motor and language scores at 12 and 24 months, DAS-II scores at 36 months, the Conners' Rating Scales-Revised at 48 months, and scores from the Child Behavior Checklist"", 'mean maternal age', 'rates of language delay (language scores', 'Maternal socioeconomic characteristics']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023012', 'cui_str': 'Language Delay'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0948465', 'cui_str': 'Thyroxine therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0023012', 'cui_str': 'Language Delay'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]",,0.169906,"After adjusting for potential confounders, there were no significant differences in primary or secondary neurodevelopment outcome between offspring exposed to HDP and those unexposed.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Palatnik', 'Affiliation': 'Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, United States.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Varner', 'Affiliation': 'Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, United States.'}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Sorokin', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': 'Yale University School of Medicine, New Haven, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Wapner', 'Affiliation': 'OB/GYN, Columbia University Medical Center, New York, United States.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Saade', 'Affiliation': 'OB-GYN, UTMB, Galveston, United States.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Tita', 'Affiliation': 'Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, United States.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, United States.'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'Obstetrics & Gynecology, University of Texas Health Sciences Center at Houston, Houston, United States.'}, {'ForeName': 'Maged M', 'Initials': 'MM', 'LastName': 'Costantine', 'Affiliation': 'Maternal-Fetal Medicine, Ohio State University Wexner Medical Center, Columbus, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mercer', 'Affiliation': 'Ob/Gyn, Suite G240, MetroHealth Medical Center, Clevelans, United States.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Tolosa', 'Affiliation': 'Oregon Health Sciences University, Portland, Portland, United States.'}, {'ForeName': 'Steve N', 'Initials': 'SN', 'LastName': 'Caritis', 'Affiliation': ''}]",American journal of perinatology,['10.1055/a-1692-0659']
2576,34753183,Factors Associated with Outpatient Therapy Utilization in Extremely Preterm Infants.,"Objective Factors influencing utilization of outpatient interventional therapies for extremely low gestational age newborns (ELGANs) after discharge remain poorly characterized, despite significant risk of neurodevelopmental impairment. We sought to assess the effects of maternal, infant, and environmental characteristics on outpatient therapy utilization in the first two years after discharge using data from the Preterm Erythropoietin Neuroprotection (PENUT) Trial. Study Design This is a secondary analysis of 818 24-27 weeks' gestation infants enrolled in the PENUT trial who survived through discharge and completed at least one follow-up call or in-person visit between 4 and 24 months of age. Utilization of a state early intervention program (EI), physical (PT), occupational (OT), and speech (ST) therapies was recorded. Odds ratios and cumulative frequency curves for resource utilization were calculated for patient characteristics adjusting for gestational age, treatment group, and birth weight. Results 37% of infants did not access EI and 18% did not use any service (PT/OT/ST/EI). Infants diagnosed with severe morbidities (IVH, ROP, BPD, NEC), discharged with home oxygen, or with gastrostomy placement experienced increased utilization of PT, OT and ST compared to peers. However, substantial variation in service utilization occurred by state of enrollment and selected maternal characteristics. Conclusions ELGANs with severe medical comorbidities are more likely to utilize services after discharge. Therapy utilization may be impacted by maternal characteristics and state of enrollment. Outpatient therapy services remain significantly underutilized in this high-risk cohort. Further research is required to characterize and optimize utilization of therapy services following NICU discharge of ELGANs.",2021,"Objective Factors influencing utilization of outpatient interventional therapies for extremely low gestational age newborns (ELGANs) after discharge remain poorly characterized, despite significant risk of neurodevelopmental impairment.","['Extremely Preterm Infants', ""818 24-27 weeks' gestation infants enrolled in the PENUT trial who survived through discharge and completed at least one follow-up call or in-person visit between 4 and 24 months of age"", 'Infants diagnosed with severe morbidities (IVH, ROP, BPD, NEC), discharged with home oxygen, or with', 'extremely low gestational age newborns']",['gastrostomy placement'],"['Utilization of a state early intervention program (EI), physical (PT), occupational (OT), and speech (ST) therapies', 'Odds ratios and cumulative frequency curves for resource utilization', 'service utilization', 'utilization of PT, OT and ST']","[{'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0598958', 'cui_str': 'Neuron Protection'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0421203', 'cui_str': 'Home oxygen supply'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]","[{'cui': 'C0017196', 'cui_str': 'Gastrostomy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0009460', 'cui_str': 'Communication disorder'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}]",,0.0537887,"Objective Factors influencing utilization of outpatient interventional therapies for extremely low gestational age newborns (ELGANs) after discharge remain poorly characterized, despite significant risk of neurodevelopmental impairment.","[{'ForeName': 'Adharsh', 'Initials': 'A', 'LastName': 'Ponnapakkam', 'Affiliation': 'Pediatrics, SAUSHEC, Fort Sam Houston, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Carr', 'Affiliation': 'University of Utah Medical Center, Salt Lake City, United States.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Comstock', 'Affiliation': 'University of Washington, Seattle, United States.'}, {'ForeName': 'Krystle', 'Initials': 'K', 'LastName': 'Perez', 'Affiliation': 'University of Washington, Seattle, United States.'}, {'ForeName': 'T Michael', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, United States.'}, {'ForeName': 'Veeral N', 'Initials': 'VN', 'LastName': 'Tolia', 'Affiliation': 'Baylor Scott and White Health, Dallas, United States.'}, {'ForeName': 'Reese', 'Initials': 'R', 'LastName': 'Clark', 'Affiliation': 'Pediatrix-Obstetrix Center for Research and Education, Sunrise, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'University of Washington, Seattle, United States.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'University of Washington, Seattle, United States.'}, {'ForeName': 'Kaashif Aqeeb', 'Initials': 'KA', 'LastName': 'Ahmad', 'Affiliation': 'Pediatrix Medical Group of San Antonio, San Antonio, United States.'}]",American journal of perinatology,['10.1055/a-1692-0544']
2577,34753153,Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors: A Randomized Controlled Trial.,"The aim of this single-blinded, randomized controlled study was to determine the effectiveness of vapocoolant spray in reducing pain related to venipuncture in young, healthy male blood donors. The participants were separated into 2 groups by randomization. The donors in the control group (n = 44) were not given any intervention during the blood collection process. Vapocoolant spray was applied to the donors in the vapocoolant spray group (n = 44). The pain score was 1.90 ± 1.47 for the vapocoolant spray group and 3.23 ± 2.21 for the control group, and the difference between the groups was found to be statistically significant (P = .02). The study result showed that the use of vapocoolant spray for pain management is an effective method of reducing pain related to venipuncture during the process of blood donation in young male donors.",2021,Vapocoolant spray was applied to the donors in the vapocoolant spray group (n = 44).,"['young, healthy male blood donors', 'Young Male Donors', 'young male donors']","['vapocoolant spray', 'Vapocoolant Spray', 'Vapocoolant spray']","['pain', 'Venipuncture Pain', 'pain score']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",44.0,0.0755555,Vapocoolant spray was applied to the donors in the vapocoolant spray group (n = 44).,"[{'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Basak', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Faculty of Nursing, Fundamentals of Nursing Department, Etlik Ankara, Turkey (Dr Basak); University of Health Sciences Turkey, Hamidiye Faculty of Nursing, Fundamentals of Nursing Department Istanbul, Turkey (Dr Aciksoz); University of Health Sciences Turkey, Gulhane Training and Research Hospital, Infectious Diseases and Clinical Microbiology, Etlik Ankara, Turkey (Drs Savasci and Yilmaz).'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Aciksoz', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Faculty of Nursing, Fundamentals of Nursing Department, Etlik Ankara, Turkey (Dr Basak); University of Health Sciences Turkey, Hamidiye Faculty of Nursing, Fundamentals of Nursing Department Istanbul, Turkey (Dr Aciksoz); University of Health Sciences Turkey, Gulhane Training and Research Hospital, Infectious Diseases and Clinical Microbiology, Etlik Ankara, Turkey (Drs Savasci and Yilmaz).'}, {'ForeName': 'Umit', 'Initials': 'U', 'LastName': 'Savasci', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Faculty of Nursing, Fundamentals of Nursing Department, Etlik Ankara, Turkey (Dr Basak); University of Health Sciences Turkey, Hamidiye Faculty of Nursing, Fundamentals of Nursing Department Istanbul, Turkey (Dr Aciksoz); University of Health Sciences Turkey, Gulhane Training and Research Hospital, Infectious Diseases and Clinical Microbiology, Etlik Ankara, Turkey (Drs Savasci and Yilmaz).'}, {'ForeName': 'Soner', 'Initials': 'S', 'LastName': 'Yilmaz', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Faculty of Nursing, Fundamentals of Nursing Department, Etlik Ankara, Turkey (Dr Basak); University of Health Sciences Turkey, Hamidiye Faculty of Nursing, Fundamentals of Nursing Department Istanbul, Turkey (Dr Aciksoz); University of Health Sciences Turkey, Gulhane Training and Research Hospital, Infectious Diseases and Clinical Microbiology, Etlik Ankara, Turkey (Drs Savasci and Yilmaz).'}]",Journal of infusion nursing : the official publication of the Infusion Nurses Society,['10.1097/NAN.0000000000000443']
2578,34753154,A Comparison of Local Anesthetics for Intravenous Catheter Insertion in Hospitalized Pediatric Patients: A Randomized Clinical Pilot Trial.,"Peripheral intravenous catheter (PIVC) insertion is one of the most painful procedures pediatric patients undergo during hospitalization. To date, local anesthetics delivered via cream, patch, and needle-free injection have not been rigorously evaluated together. This study aimed to investigate feasibility and potential efficacy of local anesthetics on pain intensity during PIVC insertion in an unblinded, single-center, randomized clinical pilot trial. Between March 2017 and February 2020, 88 hospitalized children aged 12 months to 18 years in an acute pediatric unit at an academic medical center were randomized to 1 of 3 local anesthetics: 1) lidocaine/prilocaine cream, 2) lidocaine/tetracaine patch, and 3) unbuffered lidocaine needle-free injection. Feasibility outcomes were recruitment and protocol adherence. Pain intensity was measured using the Face, Legs, Activity, Cry, Consolability (age <8 years) and Verbal Numeric Rating (VNRS) scales (age ≥8 years) before, during, and after procedure. Secondary outcomes included catheterization attempts, procedure time, and parent satisfaction. Recruitment rate was acceptable (2.7 patients per month). Protocol adherence was high (92%). Preliminary clinical findings showed no significant difference in pain intensity across treatments. Procedure time to successful insertion differed in the VNRS group, favoring unbuffered lidocaine needle-free injection. Conduct of a definitive, full-scale randomized clinical trial in the hospitalized pediatric population is feasible.",2021,Preliminary clinical findings showed no significant difference in pain intensity across treatments.,"['Between March 2017 and February 2020, 88 hospitalized children aged 12 months to 18 years in an acute pediatric unit at an academic medical center', 'painful procedures pediatric patients undergo during hospitalization', 'hospitalized pediatric population', 'Hospitalized Pediatric Patients']","['lidocaine/prilocaine cream, 2) lidocaine/tetracaine patch, and 3) unbuffered lidocaine needle-free injection', 'Intravenous Catheter Insertion', 'local anesthetics', 'Peripheral intravenous catheter (PIVC) insertion', 'lidocaine', 'Local Anesthetics']","['catheterization attempts, procedure time, and parent satisfaction', 'Pain intensity', 'Procedure time to successful insertion', 'Protocol adherence', 'Recruitment rate', 'Face, Legs, Activity, Cry, Consolability (age <8 years) and Verbal Numeric Rating (VNRS) scales', 'pain intensity']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C1628498', 'cui_str': 'Lidocaine- and tetracaine-containing product'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}]","[{'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",88.0,0.0661074,Preliminary clinical findings showed no significant difference in pain intensity across treatments.,"[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lozano', 'Affiliation': ""University of California Los Angeles Medical Center, Santa Monica, California (Ms Lozano); University of California Los Angeles Mattel Children's Hospital, Los Angeles, California (Ms Sund); University of California Los Angeles Health, Los Angeles, California (Drs Guimera, Deukmedjian, and Miller).""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Sund', 'Affiliation': ""University of California Los Angeles Medical Center, Santa Monica, California (Ms Lozano); University of California Los Angeles Mattel Children's Hospital, Los Angeles, California (Ms Sund); University of California Los Angeles Health, Los Angeles, California (Drs Guimera, Deukmedjian, and Miller).""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Guimera', 'Affiliation': ""University of California Los Angeles Medical Center, Santa Monica, California (Ms Lozano); University of California Los Angeles Mattel Children's Hospital, Los Angeles, California (Ms Sund); University of California Los Angeles Health, Los Angeles, California (Drs Guimera, Deukmedjian, and Miller).""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Deukmedjian', 'Affiliation': ""University of California Los Angeles Medical Center, Santa Monica, California (Ms Lozano); University of California Los Angeles Mattel Children's Hospital, Los Angeles, California (Ms Sund); University of California Los Angeles Health, Los Angeles, California (Drs Guimera, Deukmedjian, and Miller).""}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Miller', 'Affiliation': ""University of California Los Angeles Medical Center, Santa Monica, California (Ms Lozano); University of California Los Angeles Mattel Children's Hospital, Los Angeles, California (Ms Sund); University of California Los Angeles Health, Los Angeles, California (Drs Guimera, Deukmedjian, and Miller).""}]",Journal of infusion nursing : the official publication of the Infusion Nurses Society,['10.1097/NAN.0000000000000449']
2579,34753085,Results of a feasibility randomised controlled trial of osteopathy on neck-shoulder pain in computer users.,"BACKGROUND


Computer use is a well-known source of chronic pain, leading to absenteeism and reduced productivity and well-being. This study evaluated the feasibility of conducting a full-scale randomised controlled trial. Several methodological variables defined trial feasibility.
MATERIALS AND METHODS


Thirty adults, daily computer users reporting pain, were recruited. Data collection took place at LABIOMEP. Participants were randomised into 1 of 3 parallel groups and received either osteopathic, sham or no treatment. Only the volunteers were blind to group assignments. The primary objective was to study the feasibility and acceptability of the protocol.
RESULTS


Of 77 participants interested, 30 were included and randomised into three groups of ten. All participants concluded the study, and all the data was analysed. The feasibility outcomes were deemed appropriate. No adverse events or severe side effects were reported or identified.
CONCLUSION


Studying the efficacy of osteopathic consultation on computer users by conducting an RCT is feasible and safe. With adjustments, a full-scale study can be designed.
TRIAL REGISTRATION


ClinicalTrials.gov with the identifier: NCT04501575. Date registered August 06, 2020.",2021,"No adverse events or severe side effects were reported or identified.
","['computer users', 'Thirty adults, daily computer users reporting pain, were recruited', '77 participants interested, 30 were included and randomised into three groups of ten']","['osteopathic, sham or no treatment']","['neck-shoulder pain', 'feasibility and acceptability', 'adverse events or severe side effects']","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",30.0,0.45557,"No adverse events or severe side effects were reported or identified.
","[{'ForeName': 'Rui José', 'Initials': 'RJ', 'LastName': 'Santiago', 'Affiliation': 'Laboratory on Prevention of Occupational and Environmental Risks, Faculty of Engineering, University of Porto, Porto, Portugal; Porto Biomechanics Laboratory (Labiomep), University of Porto, Porto, Portugal; Clinical-based Human Research Department, Research Division, COME Collaboration, Pescara, Italy. Electronic address: rui.santiago@gmail.com.'}, {'ForeName': 'Jorge Eduardo', 'Initials': 'JE', 'LastName': 'Esteves', 'Affiliation': 'Clinical-based Human Research Department, Research Division, COME Collaboration, Pescara, Italy; University College of Osteopathy, London, UK; Malta ICOM Educational, Malta; Camilo Jose Cela University, Madrid, Spain. Electronic address: osteojorge@gmail.com.'}, {'ForeName': 'João Santos', 'Initials': 'JS', 'LastName': 'Baptista', 'Affiliation': 'Laboratory on Prevention of Occupational and Environmental Risks, Faculty of Engineering, University of Porto, Porto, Portugal; Associated Laboratory for Energy, Transports and Aeronautics, Faculty of Engineering, University of Porto, Porto, Portugal. Electronic address: jsbap@fe.up.pt.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Magalhães', 'Affiliation': 'School of Health Sciences, University Fernando Pessoa, Porto, Portugal. Electronic address: andrem@ufp.edu.pt.'}, {'ForeName': 'José Torres', 'Initials': 'JT', 'LastName': 'Costa', 'Affiliation': 'Laboratory on Prevention of Occupational and Environmental Risks, Faculty of Medicine, University of Porto, Porto, Portugal. Electronic address: zecatoco@sapo.pt.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101507']
2580,34753530,Protocol for a quasi-experimental study examining the effect of a ball skills intervention on four domains of preschooler development.,"BACKGROUND


Preschooler inactivity and insufficient motor development have serious long-term consequences. The Chinese Ministry of Education launched a nationwide football-focused pilot project aimed at kindergartens in 2019 and issued the policy ""Notice on the Establishment of National Football Kindergartens"" in 2020. However, the impact of fundamental movement skills (FMS) interventions on other aspects of child development is unclear.
AIM


This study will evaluate the effects of ball skills physical education projects on the development of Chinese preschoolers' physical, motor, cognitive, and social competencies and examine the influencing factors.
METHOD


This is a quasi-experimental study evaluating how well the ""Hello Sunshine"" curriculum project promotes children's development over 10 weeks. The trial will be conducted from September 2021 to November 2021 in 12 classes from 3 kindergartens with a total of 249 children aged 4 to 6 years in Haikou, China. Pre- and posttest analyses will include tests on participants' physical fitness, FMS, cognitive self-regulation, and emotional competence. Participants' background information will be collected through questionnaires answered by parents and teachers. The intervention will focus on game-based basic ball skills.
FINDINGS


If this intervention provides evidence that these skills improve children's multidimensional development, it will support the promotion of similar programs in China. We will also outline the social-ecological factors affecting the intervention's results, providing further information for improving pedagogical methods related to preschool ball skills.",2021,"Pre- and posttest analyses will include tests on participants' physical fitness, FMS, cognitive self-regulation, and emotional competence.","['September 2021 to November 2021 in 12 classes from 3 kindergartens with a total of 249 children aged 4 to 6 years in Haikou, China']","['fundamental movement skills (FMS) interventions', 'ball skills intervention', 'ball skills physical education projects']","[""Chinese preschoolers' physical, motor, cognitive, and social competencies"", ""participants' physical fitness, FMS, cognitive self-regulation, and emotional competence""]","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",249.0,0.0344688,"Pre- and posttest analyses will include tests on participants' physical fitness, FMS, cognitive self-regulation, and emotional competence.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Wichai', 'Initials': 'W', 'LastName': 'Eungpinichpong', 'Affiliation': 'Division of Physical Therapy, Faculty of Associated Medical Sciences, BNOJHP Research Center, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ruan', 'Affiliation': 'Faculty of Physical Education, Hainan Normal University, Haikou, China.'}, {'ForeName': 'Xinding', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Physical Education, Hainan Normal University, Haikou, China.'}, {'ForeName': 'Sansan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Central Kindergarten of Haikou, Haikou, China.'}, {'ForeName': 'Caijin', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Central Kindergarten of Haikou, Haikou, China.'}]",Primary health care research & development,['10.1017/S1463423621000645']
2581,34753522,The feasibility of a peer support intervention to encourage adoption and maintenance of a Mediterranean diet in established community groups at increased CVD risk: the TEAM-MED EXTEND study: a pilot cluster randomised controlled trial.,"This study aimed to evaluate the feasibility of a peer support intervention to encourage adoption and maintenance of a Mediterranean diet (MD) in established community groups where existing social support may assist the behaviour change process. Four established community groups with members at increased Cardiovascular Disease (CVD) risk and homogenous in gender were recruited and randomised to receive either a 12-month Peer Support (PS) intervention (PSG) (n 2) or a Minimal Support intervention (educational materials only) (MSG) (n 2). The feasibility of the intervention was assessed using recruitment and retention rates, assessing the variability of outcome measures (primary outcome: adoption of an MD at 6 months (using a Mediterranean Diet Score (MDS)) and process evaluation measures including qualitative interviews. Recruitment rates for community groups (n 4/8), participants (n 31/51) and peer supporters (n 6/14) were 50 %, 61 % and 43 %, respectively. The recruitment strategy faced several challenges with recruitment and retention of participants, leading to a smaller sample than intended. At 12 months, a 65 % and 76·5 % retention rate for PSG and MSG participants was observed, respectively. A > 2-point increase in MDS was observed in both the PSG and the MSG at 6 months, maintained at 12 months. An increase in MD adherence was evident in both groups during follow-up; however, the challenges faced in recruitment and retention suggest a definitive study of the peer support intervention using current methods is not feasible and refinement based on the current feasibility study should be incorporated. Lessons learned during the implementation of this intervention will help inform future interventions in this area.",2021,"A > 2-point increase in MDS was observed in both the PSG and the MSG at 6 months, maintained at 12 months.",['Four established community groups with members at increased Cardiovascular Disease (CVD) risk and homogenous in gender'],"['Mediterranean diet', '12-month Peer Support (PS) intervention (PSG) (n 2) or a Minimal Support intervention (educational materials only) (MSG', 'peer support intervention', 'Mediterranean diet (MD']","['MDS', 'Mediterranean Diet Score (MDS)) and process evaluation measures including qualitative interviews', 'MD adherence', 'CVD risk', 'retention rate']","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0037511', 'cui_str': 'Monosodium glutamate'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",4.0,0.0715575,"A > 2-point increase in MDS was observed in both the PSG and the MSG at 6 months, maintained at 12 months.","[{'ForeName': 'Roisin F', 'Initials': 'RF', 'LastName': ""O'Neill"", 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, A, Grosvenor Road, BelfastBT12 6BJ, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McGowan', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, A, Grosvenor Road, BelfastBT12 6BJ, UK.""}, {'ForeName': 'Claire T', 'Initials': 'CT', 'LastName': 'McEvoy', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, A, Grosvenor Road, BelfastBT12 6BJ, UK.""}, {'ForeName': 'Sara Megan', 'Initials': 'SM', 'LastName': 'Wallace', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, A, Grosvenor Road, BelfastBT12 6BJ, UK.""}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Moore', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, A, Grosvenor Road, BelfastBT12 6BJ, UK.""}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'McKinley', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, A, Grosvenor Road, BelfastBT12 6BJ, UK.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kee', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, A, Grosvenor Road, BelfastBT12 6BJ, UK.""}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Cupples', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, A, Grosvenor Road, BelfastBT12 6BJ, UK.""}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Young', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, A, Grosvenor Road, BelfastBT12 6BJ, UK.""}, {'ForeName': 'Jayne V', 'Initials': 'JV', 'LastName': 'Woodside', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, A, Grosvenor Road, BelfastBT12 6BJ, UK.""}]",The British journal of nutrition,['10.1017/S0007114521004050']
2582,34753515,"Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial.","BACKGROUND


Sugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex, neostigmine, and postoperative pulmonary complications.
METHODS


Patients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong. Perioperative care was at the discretion of clinicians, except for the use of rocuronium and/or vecuronium for neuromuscular blockade and the randomised intervention (sugammadex or neostigmine) for reversal. Feasibility measurements included recruitment, crossover, acceptability, completeness, and workload. Trial coordinator feedback was systematically sought. Patient-reported quality of life was measured using the EQ-5D-5L score. The primary pilot outcome was the incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital).
RESULTS


Among 150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86%). The randomised intervention was administered without crossover to 115 of 117 patients who received reversal (98%, 95% CI 94 to 100%). The protocol was acceptable or highly acceptable to the anaesthetist in 108 of 116 cases (93%, 95% CI 87 to 97%; missing = 4). Four patients of the 120 patients were lost to follow-up at 3 months (3.3%, 95% CI 0.9 to 8.3%). Case report forms were complete at 3 months for all remaining patients. The median time to complete trial processes was 3.5 h (range 2.5-4.5 h). Trial coordinators reported no barriers to trial processes. Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47%]). The primary outcome was observed in 5 (8.5%) of the 59 sugammadex patients and 5 (8.2%) of the 61 neostigmine patients (odds ratio 1.02, 95% CI 0.28 to 3.67).
CONCLUSIONS


A large international randomised controlled trial of sugammadex, neostigmine and postoperative pulmonary complications in adult patients having abdominal and intrathoracic surgery, including collection of cost-effectiveness evidence for Health Technology Appraisal, is feasible.
TRIAL REGISTRATION


Prospectively registered at the Australian and New Zealand Clinical Trials Registry ( ACTRN12620001313921 ) on December 7, 2020. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380645&isReview=true .",2021,The median time to complete trial processes was 3.5 h (range 2.5-4.5 h).,"['150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86', 'Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47', 'Patients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong', 'adult patients having abdominal and intrathoracic surgery']","['Sugammadex, neostigmine', 'rocuronium and/or vecuronium', 'sugammadex, neostigmine', 'www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380645&isReview=true ', 'intervention (sugammadex or neostigmine']","['quality of life', 'incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital', 'acceptability, completeness, and workload', 'EQ-5D-5L score', 'median time to complete trial processes']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0242531', 'cui_str': 'Vecuronium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",120.0,0.641854,The median time to complete trial processes was 3.5 h (range 2.5-4.5 h).,"[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': 'Department of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia. kate.leslie@mh.org.au.'}, {'ForeName': 'Matthew T V', 'Initials': 'MTV', 'LastName': 'Chan', 'Affiliation': ""Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong, The Prince of Wales Hospital, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Jai N', 'Initials': 'JN', 'LastName': 'Darvall', 'Affiliation': 'Department of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Anurika P', 'Initials': 'AP', 'LastName': 'De Silva', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Braat', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Devlin', 'Affiliation': 'Health Economics Unit, Melbourne School of Population and Global Health, Melbourne, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Peyton', 'Affiliation': 'Department of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Radnor', 'Affiliation': 'Department of Anaesthesia and Pain Management, Northeast Health Wangaratta, Wangaratta, Australia.'}, {'ForeName': 'Carmen K M', 'Initials': 'CKM', 'LastName': 'Lam', 'Affiliation': ""Department of Anaesthesia and Operating Room Services, Tuen Mun Hospital, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Sidiropoulos', 'Affiliation': 'Department of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Story', 'Affiliation': 'Department of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00942-9']
2583,34753488,Correction to: An exploratory non-randomized study of a 3-month electronic nicotine delivery system (ENDS) intervention with people accessing a homeless supported temporary accommodation service (STA) in Ireland.,,2021,,['people accessing a homeless supported temporary accommodation service (STA) in Ireland'],['electronic nicotine delivery system (ENDS) intervention'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0531169,,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Scheibein', 'Affiliation': 'School of Health Science, Waterford Institute of Technology, Waterford, Ireland. florian.scheibein@wit.ie.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGirr', 'Affiliation': 'University of California San Francisco, San Francisco, USA.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': 'New Nicotine Alliance, London, UK.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Roche', 'Affiliation': 'Nutritional Research Centre Ireland, Waterford Institute of Technology, Waterford, Ireland.'}, {'ForeName': 'John Stephen Gary', 'Initials': 'JSG', 'LastName': 'Wells', 'Affiliation': 'School of Health Science, Waterford Institute of Technology, Waterford, Ireland.'}]",Harm reduction journal,['10.1186/s12954-021-00549-6']
2584,34753480,Effect of empagliflozin on ketone bodies in patients with stable chronic heart failure.,"BACKGROUND


Recent studies indicated that sodium glucose cotransporter (SGLT)2 inhibition increases levels of ketone bodies in the blood in patients with type 1 and 2 diabetes. Other studies suggested that in patients with chronic heart failure (CHF), increased myocardial oxygen demand can be provided by ketone bodies as a fuel substrate. Experimental studies reported that ketone bodies, specifically beta-hydroxybutyrate (β-OHB) may increase blood pressure (BP) by impairing endothelium-dependant relaxation, thereby leading to increased vascular stiffness. In our study we assessed whether the SGLT 2 inhibition with empagliflozin increases ketone bodies in patients with stable CHF and whether such an increase impairs BP and vascular function.
METHODS


In a prospective, double blind, placebo controlled, parallel-group single centre study 75 patients with CHF (left ventricular ejection fraction 39.0 ± 8.2%) were randomised (2:1) to the SGLT-2 inhibitor empagliflozin 10 mg orally once daily or to placebo, 72 patients completed the study. After a run-in phase we evaluated at baseline BP by 24 h ambulatory blood pressure (ABP) monitoring, vascular stiffness parameters by the SphygmoCor system (AtCor Medical, Sydney, NSW, Australia) and fasting metabolic parameters, including β-OHB by an enzymatic assay (Beckman Coulter DxC 700 AU). The same measurements were repeated 12 weeks after treatment. In 19 of the 72 patients serum levels of β-OHB were beneath the lower border of our assay (< 0.05 mmol/l) therefore being excluded from the subsequent analysis.
RESULTS


In patients with stable CHF, treatment with empagliflozin (n = 36) was followed by an increase of β-OHB by 33.39% (p = 0.017), reduction in 24 h systolic (p = 0.038) and diastolic (p = 0.085) ABP, weight loss (p = 0.003) and decrease of central systolic BP (p = 0.008) and central pulse pressure (p = 0.008). The increase in β-OHB was related to an attenuated decrease of empagliflozin-induced 24 h systolic (r = 0.321, p = 0.069) and diastolic (r = 0.516, p = 0.002) ABP and less reduction of central systolic BP (r = 0.470, p = 0.009) and central pulse pressure (r = 0.391, p = 0.033). No significant changes were seen in any of these parameters after 12 weeks of treatment in the placebo group (n = 17).
CONCLUSION


In patients with stable CHF ketone bodies as assessed by β-OHB increased after treatment with empagliflozin. This increase led to an attenuation of the beneficial effects of empagliflozin on BP and vascular parameters. Trial registration The study was registered at http://www.clinicaltrials.gov (NCT03128528).",2021,"No significant changes were seen in any of these parameters after 12 weeks of treatment in the placebo group (n = 17).
","['patients with chronic heart failure (CHF', '75 patients with CHF (left ventricular ejection fraction 39.0\u2009±\u20098.2', 'patients with stable chronic heart failure', 'patients with type 1 and 2 diabetes', 'patients with stable CHF']","['empagliflozin', 'placebo', 'SGLT-2 inhibitor empagliflozin', 'sodium glucose cotransporter (SGLT)2 inhibition']","['central pulse pressure', 'central systolic BP', 'diastolic', 'BP and vascular function', 'ketone bodies', 'ambulatory blood pressure (ABP) monitoring, vascular stiffness parameters by the SphygmoCor system (AtCor Medical, Sydney, NSW, Australia) and fasting metabolic parameters, including β-OHB by an enzymatic assay (Beckman Coulter DxC 700 AU', 'weight loss', 'serum levels of β-OHB', 'β-OHB', 'BP and vascular parameters', 'blood pressure (BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036071', 'cui_str': 'salicylamide'}, {'cui': 'C2717977', 'cui_str': 'Enzymatic Assays'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",75.0,0.127779,"No significant changes were seen in any of these parameters after 12 weeks of treatment in the placebo group (n = 17).
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pietschner', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kolwelter', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bosch', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Striepe', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kannenkeril', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ott', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schiffer', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': 'Department of Cardiology, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054, Erlangen, Germany. Roland.Schmieder@uk-erlangen.de.'}]",Cardiovascular diabetology,['10.1186/s12933-021-01410-7']
2585,34753433,Sustaining success: a qualitative study of gay and bisexual men's experiences and perceptions of HIV self-testing in a randomized controlled trial.,"BACKGROUND


HIV self-testing was proved as an effective tool for increasing testing frequency in gay and bisexual men at high risk of infection. Questions remain about understanding why HIVST encouraged testing and how such success can be translated to programmatic implementation.
METHODS


We conducted a qualitative investigation of how FORTH participants experienced and perceived HIVST. Stratified sampling was used to recruit gay and bisexual men participating in the FORTH HIVST intervention to take part in interviews, focusing on infrequent testers and those who had received inaccurate HIVST results.
RESULTS


Our analysis identified several prominent themes organized into two overarching domains from the 15 interviews: (i) aspects of HIVST contributing to HIV testing frequency, and (ii) sustaining HIVST into the future. Participants also believed that their use of HIVST in the future would depend on the test kit's reliability, particularly when compared with highly reliable clinic-based testing.
CONCLUSION


HIVST increases the frequency of HIV testing among gay and bisexual men due, in part, to the practical, psychological, and social benefits it offers. To capitalize fully on these benefits, however, strategies to ensure the availability of highly reliable HIVST are required to sustain benefits beyond the confines of a structured research study.",2021,"BACKGROUND


HIV self-testing was proved as an effective tool for increasing testing frequency in gay and bisexual men at high risk of infection.","[""gay and bisexual men's experiences and perceptions of HIV self-testing"", 'gay and bisexual men participating in the', 'gay and bisexual men at high risk of infection']","['HIVST', 'FORTH HIVST intervention to take part in interviews, focusing on infrequent testers and those who had received inaccurate HIVST results']",['frequency of HIV testing'],"[{'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0183885', 'cui_str': 'Tester'}, {'cui': 'C0443236', 'cui_str': 'Inaccurate'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}]",,0.146972,"BACKGROUND


HIV self-testing was proved as an effective tool for increasing testing frequency in gay and bisexual men at high risk of infection.","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Guy', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kirsty S', 'Initials': 'KS', 'LastName': 'Smith', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Muhammad S', 'Initials': 'MS', 'LastName': 'Jamil', 'Affiliation': 'Global HIV, Hepatitis and STI Programme, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Prestage', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Tanya L', 'Initials': 'TL', 'LastName': 'Applegate', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Damian P', 'Initials': 'DP', 'LastName': 'Conway', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Holt', 'Affiliation': 'Centre for Social Research in Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Keen', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Bavinton', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'McNulty', 'Affiliation': 'Sydney Sexual Health Centre, South Eastern Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Batrouney', 'Affiliation': 'Thorne Harbour Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Cairns Sexual Health Service, Cairns North, QLD, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Vaughan', 'Affiliation': 'ACON, Sydney, NSW, Australia.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Fairley', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Grulich', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kaldor', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Denton', 'Initials': 'D', 'LastName': 'Callander', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia. d.callander@columbia.edu.'}]",BMC public health,['10.1186/s12889-021-12011-0']
2586,34753431,Effect of short-term psychological intervention on anxiety of pregnant women with positive screening results for chromosomal disorders: a randomized controlled trial.,"BACKGROUND AND AIM


Prenatal diagnosis of fetal abnormalities is a critical and stressful event for women. Most pregnant women are concerned about fetal abnormalities and screening tests. Due to the importance of anxiety reduction in pregnant women, this study was conducted to determine the effect of short-term psychological intervention on the anxiety of pregnant women with positive screening results for chromosomal disorders.
METHODS


A randomized clinical trial was performed on women referred to Akbarabadi Hospital in Tehran, Iran, who had positive screening results for chromosomal abnormalities. Participants were selected from eligible individuals by a continuous method and were assigned to two groups of cognitive-behavioral training (n = 46) and control (n = 46), using the block balanced randomization method. Participants in the cognitive-behavioral training group received 4 sessions of individual counseling. The control group received routine pregnancy visits. The Spielberger State-Trait Anxiety Inventory was completed before the intervention and immediately at the end of the intervention (before receiving the amniocentesis result). The analysis of intervention effects was performed as intention-to-treat and per-protocol analysis.
RESULTS


There was a statistically significant difference in post-intervention state anxiety scores and trait anxiety scores (p <  0.001) between the intervention and control groups, when their means were adjusted for pre-intervention scores for both intention-to-treat and per-protocol analysis. Also, there was a large effect size between the groups in terms of state (ITT: η p 2  = 0.63, PP: η p 2  = 0.71) and trait (ITT: η p 2  = 0.72, PP: η p 2  = 0.75) anxiety scores clinically for both intention-to-treat and per-protocol analysis. The intervention group had a statistically significant and large decrease in state and trait anxiety scores from pretrial to post-trial. In contrast, the control group had a statistically significant and medium increase in state and trait anxiety scores from pretrial to post-trial.
CONCLUSION


The results showed that cognitive-behavioral training reduced the anxiety of pregnant women with positive screening results for chromosomal disorders. According to the results, it is recommended to hold cognitive-behavioral training classes to reduce the anxiety of pregnant women with a positive screening result for chromosomal disorders.
TRIAL REGISTRATION


IRCT.ir: IRCT20180427039436N7 ; date of registration: 24/08/2020 2020-08-24.",2021,The intervention group had a statistically significant and large decrease in state and trait anxiety scores from pretrial to post-trial.,"['pregnant women with positive screening results for chromosomal disorders', 'Participants were selected from eligible individuals by a continuous method', 'pregnant women with a positive screening result for chromosomal disorders', 'women referred to Akbarabadi Hospital in Tehran, Iran, who had positive screening results for chromosomal abnormalities', 'pregnant women', 'women']","['short-term psychological intervention', 'cognitive-behavioral training', 'IRCT.ir', 'routine pregnancy visits', 'cognitive-behavioral training group received 4 sessions of individual counseling']","['state and trait anxiety scores', 'post-intervention state anxiety scores and trait anxiety scores', 'Spielberger State-Trait Anxiety Inventory']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008626', 'cui_str': 'Congenital chromosomal disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}]",,0.0393138,The intervention group had a statistically significant and large decrease in state and trait anxiety scores from pretrial to post-trial.,"[{'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Bayat', 'Affiliation': 'Department of Reproductive Health and Midwifery, Shahid Akbarabadi Clinical Research Development Unit (Sh ACRDU), School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Amiri-Farahani', 'Affiliation': 'Department of Reproductive Health and Midwifery, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, 1996713883, Iran. l.amirifarahani@gmail.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Soleimani', 'Affiliation': 'Department of Psychiatry, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Eshraghi', 'Affiliation': 'Department of Obstetrics and Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital, Tehran, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Haghani', 'Affiliation': 'Department of Biostatistics, Nursing Care Research Center, Iran University of Medical Sciences, Tehran, Iran.'}]",BMC pregnancy and childbirth,['10.1186/s12884-021-04206-5']
2587,34753425,Transmuscular quadratus lumborum block for postoperative pain and recovery after laparoscopic adrenalectomy: a randomized controlled trial.,"BACKGROUND


To investigate the role of transmuscular quadratus lumborum block (TMQLB) for postoperative pain control, patient satisfaction and recovery in laparoscopic adrenalectomy.
METHODS


Seventy-two patients aged between 18 and 70 years with an ASA I-II and scheduled for laparoscopic adrenalectomy were randomized to receive a single-shot TMQLB with 0.4 ml/kg 0.5 % ropivacaine or 0.4 ml/kg 0.9 % saline as placebo. The primary endpoint was pain on movement at 12 h after surgery evaluated by the numeric rating scale (NRS, 0-10). P-values < 0.05 was considered statistically significant. The secondary outcomes included pain at rest and pain on movement evaluated by the NRS, and postoperative recovery related parameters.
RESULTS


NRS on movement at 12 h after surgery was lower in the TMQLB group compared with the control (median 2 vs. 3, p = 0.024). Intraoperative fentanyl consumption was lower in the TMQLB group (247.08 ± 63.54 vs. 285.44 ± 74.70, p = 0.022). The rate of using postoperative rescue tramadol was also lower in the TMQLB group (5.6 vs. 27.8 %, p = 0.027). Similar incidences of nausea and vomiting were observed (11.1 vs. 25 %, p = 0.220). Patient satisfaction of pain service was better in the TMQLB group (83.3 vs. 25 %, p < 0.001) with shorter time to ambulation (16.5 vs. 21 h, p = 0.004) and flatus (18.5 vs. 23.5 h, p = 0.006).
CONCLUSIONS


TMQLB showed better control of postoperative pain on movement for laparoscopic adrenalectomy with improved patients' satisfaction of anesthesia, shorter time to ambulation and flatus.
TRIAL REGISTRATION


This study was registered at Clinicaltrials.gov ( NCT03942237 ; registration date: 08/05/2019; enrollment date: 10/05/2019).",2021,"Similar incidences of nausea and vomiting were observed (11.1 vs. 25 %, p = 0.220).",['Seventy-two patients aged between 18 and 70 years with an ASA I-II and scheduled for'],"['Transmuscular quadratus lumborum block', 'TMQLB', 'single-shot TMQLB with 0.4 ml/kg 0.5\u2009% ropivacaine or 0.4 ml/kg 0.9\u2009% saline as placebo', 'laparoscopic adrenalectomy', 'transmuscular quadratus lumborum block (TMQLB']","['pain on movement at 12\xa0h after surgery evaluated by the numeric rating scale', 'rate of using postoperative rescue tramadol', 'shorter time to ambulation', 'nausea and vomiting', 'pain at rest and pain on movement evaluated by the NRS, and postoperative recovery related parameters', 'Patient satisfaction of pain service', 'Intraoperative fentanyl consumption', 'flatus', 'satisfaction of anesthesia, shorter time to ambulation and flatus']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0521267', 'cui_str': 'Laparoscopic adrenalectomy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",72.0,0.689538,"Similar incidences of nausea and vomiting were observed (11.1 vs. 25 %, p = 0.220).","[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Sufang', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Xulei', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China. cuixulei10685@pumch.cn.'}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Medical Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Weigang', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Ji', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}]",BMC anesthesiology,['10.1186/s12871-021-01494-4']
2588,34753423,"Supraclavicular block with Mepivacaine vs Ropivacaine, their impact on postoperative pain: a prospective randomised study.","BACKGROUND


Supraclavicular block (SCB) with long-acting local anaesthetic is commonly used for surgical repair of distal radial fractures (DRF). Studies have shown a risk for rebound pain when the block fades. This randomised single-centre study aimed to compare pain and opioid consumption the first three days post-surgery between SCB-mepivacaine vs. SCB-ropivacaine, with general anaesthesia (GA) as control.
METHODS


Patients (n = 90) with ASA physical status 1-3 were prospectively randomised to receive; SCB with mepivacine 1%, 25-30 ml (n = 30), SCB with ropivacaine 0.5%, 25-30 ml (n = 30) or GA (n = 30) with propofol/fentanyl/sevoflurane. Study objectives compared postoperative pain with Numeric Rating Scale (NRS) and sum postoperative Opioid Equivalent Consumption (OEC) during the first 3 days post-surgery between study-groups.
RESULTS


The three groups showed significant differences in postoperative pain-profile. Mean NRS at 24 h was significantly lower for the SCB-mepivacaine group (p = 0.018). Further both median NRS and median OEC day 0 to 3 were significanly lower in the SCB-mepivacaine group as compared to the SCB-ropivacaine group during the first three days after surgery; pain NRS 1 (IQR 0.3-3.3) and 2.7 (IQR 1.3-4.2) (p = 0.017) and OEC 30 mg (IQR 10-80) and 85 mg (IQR 45-125) (p = 0.004), respectively. The GA-group was in between both in pain NRS and median sum OEC. Unplanned healthcare contacts were highest among SCB-ropivacaine patients (39.3%) vs. SCB-mepivacaine patients (0%) and GA-patients (3.4%).
CONCLUSIONS


The potential benefit of longer duration of analgesia, associated to a long-acting local anaesthetic agent, during the early postoperative course must be put in perspective of potential worse pain progression following block resolution.
TRIAL REGISTRATION


NCT03749174 (clinicaltrials.gov, Nov 21, 2018, retrospectively registered).",2021,Mean NRS at 24 h was significantly lower for the SCB-mepivacaine group (p = 0.018).,['Patients (n\u2009=\u200990) with ASA physical status 1-3'],"['Mepivacaine vs Ropivacaine', 'SCB-mepivacaine vs. SCB-ropivacaine, with general anaesthesia (GA', 'SCB with mepivacine', 'propofol/fentanyl/sevoflurane', 'SCB-mepivacaine', 'SCB-ropivacaine', 'SCB with ropivacaine 0.5%, 25-30\u2009ml (n\u2009=\u200930) or GA', 'mepivacaine']","['postoperative pain with Numeric Rating Scale (NRS) and sum postoperative Opioid Equivalent Consumption (OEC', 'postoperative pain-profile', 'pain and opioid consumption', 'Unplanned healthcare contacts', 'median NRS and median OEC', 'postoperative pain', 'Mean NRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.38452,Mean NRS at 24 h was significantly lower for the SCB-mepivacaine group (p = 0.018).,"[{'ForeName': 'Irén', 'Initials': 'I', 'LastName': 'Sellbrant', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden. iren.sellbrant@vgregion.se.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Karlsson', 'Affiliation': 'Department of Orthopedic Surgery, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Jakobsson', 'Affiliation': 'Department of Anaesthesia & Intensive Care, Institute of Clinical Science, Karolinska Institute, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Nellgård', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",BMC anesthesiology,['10.1186/s12871-021-01499-z']
2589,34753412,The prophylactic effect of betaxolol 0.5% versus brimonidine 0.2% on IOP elevation after Nd:YAG laser posterior capsulotomy.,"CLINICAL RELEVANCE


Posterior capsule opacification is a common late complication of cataract surgery. Posterior capsule opening with Nd:YAG laser, which is the standard treatment, may cause transient elevation of intraocular pressure (IOP).
BACKGROUND


To evaluate the efficacy of betaxolol 0.‌5% compared to brimonidine 0.2%, in prevention of intraocular pressure increase after Nd:YAG Laser posterior capsulotomy.
METHODS


In a double masked randomised clinical trial, 38 eyes from 38 pseudophakic patients over 21 years of age who had significant posterior capsule opacification after phacoemulsification were randomly assigned to receive either betaxolol 0.‌5% (18 eyes) or brimonidine 0.‌2% (20 eyes) one hour before Nd:YAG Laser posterior capsulotomy.‌ Exclusion criteria were: glaucoma or history of glaucoma surgery, active uveitis, active ocular infection, pregnancy, unstable cardiovascular condition and severe asthma and lung diseases. Intraocular pressure was measured by Goldmann applanation tonometry, 1 hour before applying the laser and 4 hours after the laser application.
RESULTS


There was no statistically significant difference between the two groups regarding the baseline mean IOP and the 4-hour post-laser mean IOP. There was a statistically significant decrease in the 4-hour post-laser mean IOP as compared to the baseline mean IOP in each group. The mean IOP change in the betaxolol group, was -2.39 ± 1.79 mm Hg and in the brimonidine group was -4.25 ± 2.20 mm Hg. The difference was statistically significant (P = 0.007). None of the patients experienced clinically significant IOP increase (≥5 mm Hg) in either group.
CONCLUSION


Use of a single topical dose of betaxolol 0.5% and brimonidine 0.2%, 1 hour before laser treatment, can prevent significant acute IOP increase after Nd:YAG laser posterior capsulotomy, and betaxolol may provide a new alternative for prophylactic use.",2021,There was a statistically significant decrease in the 4-hour post-laser mean IOP as compared to the baseline mean IOP in each group.,"['one hour before Nd:YAG Laser posterior capsulotomy.\u200c Exclusion criteria were: glaucoma or history of glaucoma surgery, active uveitis, active ocular infection, pregnancy, unstable cardiovascular condition and severe asthma and lung diseases', '38 eyes from 38 pseudophakic patients over 21\xa0years of age who had significant posterior capsule opacification after phacoemulsification']","['brimonidine', 'Posterior capsule opening with Nd:YAG laser', 'betaxolol', 'YAG laser posterior capsulotomy']","['mean IOP change', 'intraocular pressure increase', 'IOP elevation', '4-hour post-laser mean IOP', 'Intraocular pressure']","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0455517', 'cui_str': 'H/O: glaucoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0015403', 'cui_str': 'Eye infection'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0005320', 'cui_str': 'Betaxolol'}, {'cui': 'C0587069', 'cui_str': 'YAG laser posterior capsulotomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]",38.0,0.131611,There was a statistically significant decrease in the 4-hour post-laser mean IOP as compared to the baseline mean IOP in each group.,"[{'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Elmi Sadr', 'Affiliation': 'Clinical Research Development Unit, Kowsar Educational, Research and Therapeutic Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Saber', 'Affiliation': 'Clinical Research Development Unit, Kowsar Educational, Research and Therapeutic Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Paknazar', 'Affiliation': 'Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}]",Clinical & experimental optometry,['10.1080/08164622.2021.1989265']
2590,34753411,The impact of using implementation intentions as task instructions on prospective memory performance after stroke.,"Prospective Memory (PM), the ability to remember to carry out intentions in the future, is often impaired after stroke. Little is known about rehabilitation of PM post-stroke with literature limited by small sample sizes and reliance on self-reported memory performance. Implementation intentions may make prospective remembering more automatic and follow a simple if-then structure (if X occurs, then I will do Y), focusing on the cue rather than the task. We aimed to investigate the effect of implementation intentions on PM post-stroke. Twenty-eight individuals with stroke and 27 controls were randomly allocated to a standard instruction or implementation intention condition and completed an assessment battery over two sessions. Implementation intention instructions were provided for PM tasks on the Delayed Message Task, Lexical Decision Prospective Memory Task (LDPMT), and the Virtual Reality Prospective Memory Shopping Task. The implementation intention groups performed better on all PM tasks compared to the standard instruction group, but no results reached statistical significance, likely due to the small sample size. In addition, the implementation intentions group monitored the time significantly more on the LDPMT than those in the standard instruction group.",2021,"The implementation intention groups performed better on all PM tasks compared to the standard instruction group, but no results reached statistical significance, likely due to the small sample size.",['Twenty-eight individuals with stroke and 27 controls'],"['LDPMT', 'standard instruction or implementation intention condition']",[],"[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],28.0,0.00910036,"The implementation intention groups performed better on all PM tasks compared to the standard instruction group, but no results reached statistical significance, likely due to the small sample size.","[{'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Hogan', 'Affiliation': 'School of Applied Psychology and The Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Nathan, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fleming', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Queensland, Saint Lucia, Australia.'}, {'ForeName': 'Petrea', 'Initials': 'P', 'LastName': 'Cornwell', 'Affiliation': 'School of Health Sciences and Social Work, Menzies Health Institute Queensland, Griffith University, Nathan, Australia.'}, {'ForeName': 'David H K', 'Initials': 'DHK', 'LastName': 'Shum', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2021.1997766']
2591,34753386,"Health-Related Quality of Life among Children with Disabilities: Is There a Place for Parent-Proxy Reports? A Commentary on the ""The Effects of Basic Photography Education on Quality of Life, Self-Esteem, Life Satisfaction and Moods in Children with Diplegic Cerebral Palsy: A Randomized Controlled Study"".",,2021,,"['Children with Diplegic Cerebral Palsy', 'Children with Disabilities']",['Basic Photography Education'],"['Quality of Life, Self-Esteem, Life Satisfaction and Moods', 'Health-Related Quality of Life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270804', 'cui_str': 'Diplegic cerebral palsy'}, {'cui': 'C0259916', 'cui_str': 'Child, Disabled'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0434541,,"[{'ForeName': 'Mariane', 'Initials': 'M', 'LastName': 'Sentenac', 'Affiliation': 'Université de Paris, CRESS, Obstetrical Perinatal and Pediatric Epidemiology Research Team, EPOPé, INSERM, INRA, Paris, France.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2022.1999157']
2592,34753329,A novel technique of isolated gastrocnemius recession: A cadaveric comparison with Strayer procedure.,"BACKGROUND


Strayer's gastrocnemius recession is a common technique in treating ankle equinus of gastrocnemius origin. Nevertheless, this technique is associated with a few flaws. We aim to introduce a novel technique of isolated gastrocnemius recession and perform a cadaveric study to evaluate its safety and at the same time compare this novel technique with the existing Strayer procedure biomechanically.
METHODS


Eight fresh cadaveric models of gastrocnemius tightness were established by isolated traction of the gastrocnemius muscles. Gastrocnemius recession was performed on all eight models with Strayer method and the novel method randomized equally. The safety of both the techniques was evaluated by identifying any iatrogenic injury to the surrounding structures. The lengthening and improvement of the ankle dorsiflexion was measured and compared between the two techniques.
RESULTS


There was no iatrogenic sural nerve or saphenous vein injury in all eight models. There was no significant difference between the two techniques in terms of lengthening (24.25 mm vs 21.00 mm;  p  = 0.838) and improvement of ankle dorsiflexion (26.5° vs 26°;  p  = .829).
CONCLUSIONS


Both Strayer technique and the novel technique of gastrocnemius recession lengthened the gastrocnemius and improved the ankle dorsiflexion in this cadaver trial. Both procedures were safe with proper techniques, and there was no significant difference in efficacy between them.
LEVEL OF EVIDENCE


Level II, randomized controlled trial.",2021,"There was no significant difference between the two techniques in terms of lengthening (24.25 mm vs 21.00 mm;  p  = 0.838) and improvement of ankle dorsiflexion (26.5° vs 26°;  p  = .829).
","['isolated gastrocnemius recession', 'Eight fresh cadaveric models of gastrocnemius tightness were established by isolated traction of the gastrocnemius muscles']",[],"['ankle dorsiflexion', 'iatrogenic sural nerve or saphenous vein injury', 'lengthening and improvement of the ankle dorsiflexion', 'improvement of ankle dorsiflexion']","[{'cui': 'C0188316', 'cui_str': 'Gastrocnemius recession'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0040597', 'cui_str': 'Traction'}]",[],"[{'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0038879', 'cui_str': 'Structure of sural nerve'}, {'cui': 'C0160758', 'cui_str': 'Injury of saphenous vein'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}]",,0.0567681,"There was no significant difference between the two techniques in terms of lengthening (24.25 mm vs 21.00 mm;  p  = 0.838) and improvement of ankle dorsiflexion (26.5° vs 26°;  p  = .829).
","[{'ForeName': 'Ren Yi', 'Initials': 'RY', 'LastName': 'Kow', 'Affiliation': 'Department of Orthopaedics, Traumatology & Rehabilitation, 162083International Islamic University Malaysia, Kuantan, Pahang, Malaysia.'}, {'ForeName': 'Aminudin', 'Initials': 'A', 'LastName': 'Che-Ahmad', 'Affiliation': 'Department of Orthopaedics, Traumatology & Rehabilitation, 162083International Islamic University Malaysia, Kuantan, Pahang, Malaysia.'}, {'ForeName': 'Mohd Adham Shah', 'Initials': 'MAS', 'LastName': 'Ayeop', 'Affiliation': 'Department of Orthopaedics, Traumatology & Rehabilitation, 162083International Islamic University Malaysia, Kuantan, Pahang, Malaysia.'}, {'ForeName': 'Muhammad Wafiuddin', 'Initials': 'MW', 'LastName': 'Ahmad', 'Affiliation': 'Department of Orthopaedics, Traumatology & Rehabilitation, 162083International Islamic University Malaysia, Kuantan, Pahang, Malaysia.'}, {'ForeName': 'Shahril', 'Initials': 'S', 'LastName': 'Yusof', 'Affiliation': 'Department of Orthopaedics, Traumatology & Rehabilitation, 162083International Islamic University Malaysia, Kuantan, Pahang, Malaysia.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/23094990211043987']
2593,34753334,Examining the Effects of Integrating Anxiety Management Instruction Within a Reading Intervention for Upper Elementary Students With Reading Difficulties.,"We present findings from the first cohort of third- and fourth-grade students with reading difficulties (128 students from 31 classrooms) who participated in a 2-year intervention examining the effects of a reading intervention with and without anxiety management. Using a randomized controlled trial, students were assigned to one of three conditions: (a) small-group reading intervention with anxiety management instruction (RANX), (b) small-group reading intervention with math fact practice (RMATH), and (c) business-as-usual (BAU) comparison condition (no researcher provided treatment). Personnel from the research team provided participants in the RANX and RMATH the same reading intervention with the variation in the two treatments being whether the same amount of time per lesson was allocated to anxiety management (RANX) or practicing math facts (RMATH). Students in the RANX significantly outperformed students in the BAU on reading comprehension (effect size [ES] = 1.22) and students in the RMATH outperformed BAU on reading comprehension (ES = 0.77). Groups did not differ significantly on other reading outcomes. Reading anxiety moderated the main effect of the RANX intervention on Test of Word Reading Efficiency (TOWRE) word reading when contrasted against the BAU group indicating a significant difference favoring RANX where treatment's effect decreased by 0.94 units (about 1 point on the outcome) on word reading for each additional point increase in reading anxiety.",2021,Reading anxiety moderated the main effect of the RANX intervention on Test of Word Reading Efficiency (TOWRE) word reading when contrasted against the BAU group indicating a significant difference favoring RANX where treatment's effect decreased by 0.94 units (about 1 point on the outcome) on word reading for each additional point increase in reading anxiety.,"['first cohort of third- and fourth-grade students with reading difficulties (128 students from 31 classrooms) who participated in a 2-year intervention examining the effects of a reading intervention with and without anxiety management', 'Upper Elementary Students With Reading Difficulties']","['Integrating Anxiety Management Instruction Within a Reading Intervention', 'small-group reading intervention with anxiety management instruction (RANX), (b) small-group reading intervention with math fact practice (RMATH), and (c) business-as-usual (BAU) comparison condition (no researcher provided treatment', 'anxiety management (RANX) or practicing math facts (RMATH', 'RANX intervention']","['reading comprehension', 'reading anxiety', 'Test of Word Reading Efficiency (TOWRE) word reading']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0586742', 'cui_str': 'Difficulty reading'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0871652', 'cui_str': 'Management of anxiety'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]","[{'cui': 'C0871652', 'cui_str': 'Management of anxiety'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",128.0,0.018309,Reading anxiety moderated the main effect of the RANX intervention on Test of Word Reading Efficiency (TOWRE) word reading when contrasted against the BAU group indicating a significant difference favoring RANX where treatment's effect decreased by 0.94 units (about 1 point on the outcome) on word reading for each additional point increase in reading anxiety.,"[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Vaughn', 'Affiliation': 'The University of Texas-Austin, USA.'}, {'ForeName': 'Amie E', 'Initials': 'AE', 'LastName': 'Grills', 'Affiliation': 'Boston University, MA, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Capin', 'Affiliation': 'The University of Texas-Austin, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'The University of Texas-Austin, USA.'}, {'ForeName': 'Anna-Mária', 'Initials': 'AM', 'LastName': 'Fall', 'Affiliation': 'The University of Texas-Austin, USA.'}, {'ForeName': 'Johny', 'Initials': 'J', 'LastName': 'Daniel', 'Affiliation': 'The University of Texas-Austin, USA.'}]",Journal of learning disabilities,['10.1177/00222194211053225']
2594,34753304,Endovascular Treatment for Posterior Circulation Stroke in Routine Clinical Practice: Results of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry.,"BACKGROUND AND PURPOSE


The benefit of endovascular treatment (EVT) for posterior circulation stroke (PCS) remains uncertain, and little is known on treatment outcomes in clinical practice. This study evaluates outcomes of a large PCS cohort treated with EVT in clinical practice. Simultaneous to this observational study, several intervention centers participated in the BASICS trial (Basilar Artery International Cooperation Study), which tested the efficacy of EVT for basilar artery occlusion in a randomized setting. We additionally compared characteristics and outcomes of patients treated outside BASICS in trial centers to those from nontrial centers.
METHODS


We included patients with PCS from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry: a prospective, multicenter, observational study of patients who underwent EVT in the Netherlands between 2014 and 2018. Primary outcome was a score of 0 to 3 on the modified Rankin Scale at 90 days. Secondary outcomes included reperfusion status and symptomatic intracranial hemorrhage. For outcome comparison between patients treated in trial versus nontrial centers, we used ordinal logistic regression analysis.
RESULTS


We included 264 patients of whom 135 (51%) had received intravenous thrombolysis. The basilar artery was most often involved (77%). Favorable outcome (modified Rankin Scale score 0-3) was observed in 115/252 (46%) patients, and 109/252 (43%) patients died. Successful reperfusion was achieved in 178/238 (75%), and symptomatic intracranial hemorrhage occurred in 9/264 (3%). The 154 nontrial patients receiving EVT in BASICS trial centers had similar characteristics and outcomes as the 110 patients treated in nontrial centers (modified Rankin Scale adjusted cOR: 0.77 [95% CI, 0.5-1.2]).
CONCLUSIONS


Our study shows that high rates of favorable clinical outcome and successful reperfusion can be achieved with EVT for PCS, despite high mortality. Characteristics and outcomes of patients treated in trial versus nontrial centers were similar indicating that our cohort is representative of clinical practice in the Netherlands. Randomized studies using modern treatment approaches are needed for further insight in the benefit of EVT for PCS.",2021,"Favorable outcome (modified Rankin Scale score 0-3) was observed in 115/252 (46%) patients, and 109/252 (43%) patients died.","['posterior circulation stroke (PCS', '154 nontrial patients receiving', 'patients treated outside BASICS in trial centers to those from nontrial centers', 'patients with PCS', '264 patients of whom 135 (51%) had received', 'patients who underwent EVT in the Netherlands between 2014 and 2018', 'Acute Ischemic Stroke in the Netherlands Registry']","['intravenous thrombolysis', 'EVT', 'endovascular treatment (EVT', 'Endovascular Treatment']","['Favorable outcome (modified Rankin Scale score 0-3', 'Successful reperfusion', 'symptomatic intracranial hemorrhage', 'score of 0 to 3 on the modified Rankin Scale', 'reperfusion status and symptomatic intracranial hemorrhage']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",264.0,0.108193,"Favorable outcome (modified Rankin Scale score 0-3) was observed in 115/252 (46%) patients, and 109/252 (43%) patients died.","[{'ForeName': 'F Anne V', 'Initials': 'FAV', 'LastName': 'Pirson', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, School for Cardiovascular Diseases (CARIM), the Netherlands (F.A.V.P., R.-J.B.G., J.S., R.J.v.O.).'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Boodt', 'Affiliation': 'Department of Neurology, Erasmus University Medical Center, Rotterdam, the Netherlands. (N.B., S.J.d.H., D.W.J.D.).'}, {'ForeName': 'Josje', 'Initials': 'J', 'LastName': 'Brouwer', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Center, location AMC, the Netherlands. (J.B., J.M.C.).'}, {'ForeName': 'Agnetha A E', 'Initials': 'AAE', 'LastName': 'Bruggeman', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, location AMC, the Netherlands. (A.A.E.B., C.B.L.M.M., B.J.E.).'}, {'ForeName': 'Sanne J', 'Initials': 'SJ', 'LastName': 'den Hartog', 'Affiliation': 'Department of Neurology, Erasmus University Medical Center, Rotterdam, the Netherlands. (N.B., S.J.d.H., D.W.J.D.).'}, {'ForeName': 'Robert-Jan B', 'Initials': 'RB', 'LastName': 'Goldhoorn', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, School for Cardiovascular Diseases (CARIM), the Netherlands (F.A.V.P., R.-J.B.G., J.S., R.J.v.O.).'}, {'ForeName': 'Lucianne C M', 'Initials': 'LCM', 'LastName': 'Langezaal', 'Affiliation': 'Department of Radiology, Sint Antonius Hospital, Nieuwegein, the Netherlands (L.C.M.L., J.-A.V.).'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Staals', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, School for Cardiovascular Diseases (CARIM), the Netherlands (F.A.V.P., R.-J.B.G., J.S., R.J.v.O.).'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center, CARIM, the Netherlands (W.H.v.Z., C.v.d.L., R.J.B.B.).'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'van der Leij', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center, CARIM, the Netherlands (W.H.v.Z., C.v.d.L., R.J.B.B.).'}, {'ForeName': 'Rutger J B', 'Initials': 'RJB', 'LastName': 'Brans', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center, CARIM, the Netherlands (W.H.v.Z., C.v.d.L., R.J.B.B.).'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, location AMC, the Netherlands. (A.A.E.B., C.B.L.M.M., B.J.E.).'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Center, location AMC, the Netherlands. (J.B., J.M.C.).'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, location AMC, the Netherlands. (A.A.E.B., C.B.L.M.M., B.J.E.).'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands. (N.B., S.J.d.H., A.v.d.L.).'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'Department of Neurology, Erasmus University Medical Center, Rotterdam, the Netherlands. (N.B., S.J.d.H., D.W.J.D.).'}, {'ForeName': 'Jan-Albert', 'Initials': 'JA', 'LastName': 'Vos', 'Affiliation': 'Department of Radiology, Sint Antonius Hospital, Nieuwegein, the Netherlands (L.C.M.L., J.-A.V.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, School for Cardiovascular Diseases (CARIM), the Netherlands (F.A.V.P., R.-J.B.G., J.S., R.J.v.O.).'}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Schonewille', 'Affiliation': 'Department of Neurology, Sint Antonius Hospital, Nieuwegein, the Netherlands (W.J.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.121.034786']
2595,34753296,A feasibility study to assess the design of a multicentre randomized controlled trial of the clinical and cost-effectiveness of a caregiving intervention for people following hip fracture surgery.,"AIMS


This study aims to assess the feasibility of conducting a pragmatic, multicentre randomized controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery.
METHODS


This will be a mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomized to usual NHS care, versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme will comprise of three, one-hour, one-to-one training sessions for the patient and caregiver, delivered by a nurse, physiotherapist, or occupational therapist. Training will be delivered in the hospital setting pre-patient discharge. It will include practical skills for rehabilitation such as: transfers and walking; recovery goal setting and expectations; pacing and stress management techniques; and introduction to the HIP HELPER Caregiver Workbook, which provides information on recovery, exercises, worksheets, and goal-setting plans to facilitate a 'good' recovery. After discharge, patients and caregivers will be supported in delivering rehabilitation through three telephone coaching sessions. Data, collected at baseline and four months post-randomization, will include: screening logs, intervention logs, fidelity checklists, quality assurance monitoring visit data, and clinical outcomes assessing quality of life, physical, emotional, adverse events, and resource use outcomes. The acceptability of the study intervention and RCT design will be explored through qualitative methods with 20 participants (patients and informal caregivers) and 12 health professionals.
DISCUSSION


A multicentre recruitment approach will provide greater external validity across population characteristics in England. The mixed-methods approach will permit in-depth examination of the intervention and trial design parameters. The findings will inform whether and how a definitive trial may be undertaken to test the effectiveness of this caregiver intervention for patients after hip fracture surgery. Cite this article:  Bone Jt Open  2021;2(11):909-920.",2021,The findings will inform whether and how a definitive trial may be undertaken to test the effectiveness of this caregiver intervention for patients after hip fracture surgery.,"['60 patients following hip fracture surgery and their informal caregivers', 'people following hip fracture surgery', 'patients after hip fracture surgery', '20 participants (patients and informal caregivers) and 12 health professionals']","['usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER', 'informal caregiver training programme', 'caregiving intervention']","['screening logs, intervention logs, fidelity checklists, quality assurance monitoring visit data, and clinical outcomes assessing quality of life, physical, emotional, adverse events, and resource use outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",60.0,0.100979,The findings will inform whether and how a definitive trial may be undertaken to test the effectiveness of this caregiver intervention for patients after hip fracture surgery.,"[{'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Clark', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Khoury', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Mei-See', 'Initials': 'MS', 'LastName': 'Man', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hanson', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Welsh', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hopewell', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Geriatric Rehabilitation, Robert-Bosch-Krankenhaus GmbH, Stuttgart, Germany.'}, {'ForeName': 'Pip', 'Initials': 'P', 'LastName': 'Logan', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Costa', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}]",Bone & joint open,['10.1302/2633-1462.211.BJO-2021-0136']
2596,34753776,Identifying low-risk chest pain in the emergency department without troponin testing: a validation study of the HE-MACS and HEAR risk scores.,"INTRODUCTION


Patients presenting to EDs with chest pain of possible cardiac origin represent a substantial and challenging cohort to risk stratify. Scores such as HE-MACS (History and Electrocardiogram-only Manchester Acute Coronary Syndromes decision aid) and HEAR (History, ECG, Age, Risk factors) have been developed to stratify risk without the need for troponin testing. Validation of these scores remains limited.
METHODS


We performed a post hoc analysis of the Limit of Detection and ECG discharge strategy randomised-controlled trial dataset (n=629; June 2018 to March 2019; 8 UK hospitals) to calculate HEAR and HE-MACS scores. A <4% risk of major adverse cardiac events (MACE) at 30 days using HE-MACS and a score of <2 calculated using HEAR defined 'very low risk' patients suitable for discharge. The primary outcome of MACE at 30 days was used to assess diagnostic accuracy.
RESULTS


MACE within 30 days occurred in 42/629 (7%) of the cohort. HE-MACS and HEAR scores identified 85/629 and 181/629 patients as 'very low risk', with MACE occurring in 0/85 and 1/181 patients, respectively. The sensitivities of each score for ruling out MACE were 100% (95% CI: 91.6% to 100%) for HE-MACS and 97.6% (95% CI: 87.7% to 99.9%) for HEAR. Presenting symptoms within these scores were poorly predictive, with only diaphoresis reaching statistical significance (OR: 4.99 (2.33 to 10.67)). Conventional cardiovascular risk factors and clinician suspicion were related to the presence of MACE at 30 days.
CONCLUSION


HEAR and HE-MACS show potential as rule out tools for acute myocardial infarction without the need for troponin testing. However, prospective studies are required to further validate these scores.",2021,"Presenting symptoms within these scores were poorly predictive, with only diaphoresis reaching statistical significance (OR: 4.99 (2.33 to 10.67)).",[],['MACE'],"['HE-MACS and HEAR scores', 'HEAR and HE-MACS scores', 'diagnostic accuracy']",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0943028,"Presenting symptoms within these scores were poorly predictive, with only diaphoresis reaching statistical significance (OR: 4.99 (2.33 to 10.67)).","[{'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Todd', 'Affiliation': 'Emergency Department, North Bristol NHS Trust, Bristol, UK fst@doctors.org.uk.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Duff', 'Affiliation': 'Emergency Department, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Carlton', 'Affiliation': 'Emergency Department, North Bristol NHS Trust, Bristol, UK.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2021-211669']
2597,34753762,Supplementation with  Bifidobacterium longum  subspecies  infantis  EVC001 for mitigation of type 1 diabetes autoimmunity: the GPPAD-SINT1A randomised controlled trial protocol.,"INTRODUCTION


The Global Platform for the Prevention of Autoimmune Diabetes-SINT1A Study is designed as a randomised, placebo-controlled, double-blind, multicentre, multinational, primary prevention study aiming to assess whether daily administration of  Bifidobacterium infantis  from age 7 days to 6 weeks until age 12 months to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.
METHODS AND ANALYSIS


Infants aged 7 days to 6 weeks from Germany, Poland, Belgium, UK and Sweden are eligible for study participation if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies by age 6 years as determined by genetic risk score or family history and HLA genotype. Infants are randomised 1:1 to daily administration of  B. infantis  EVC001 or placebo until age 12 months and followed for a maximum of 5.5 years thereafter. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies. Secondary outcomes are (1) Any persistent confirmed beta-cell autoantibody, defined as at least one confirmed autoantibody in two consecutive samples, including insulin autoantibodies, glutamic acid decarboxylase, islet tyrosine phosphatase 2 or zinc transporter 8, (2) Diabetes, (3) Transglutaminase autoantibodies associated with coeliac disease, (4) Respiratory infection rate in first year of life during supplementation and (5) Safety. Exploratory outcomes include allergy, antibody response to vaccines, alterations of the gut microbiome or blood metabolome, stool pH and calprotectin.
ETHICS AND DISSEMINATION


The study was approved by the local ethical committees of the Technical University Munich, Medical Faculty, the Technische Universität Dresden, the Medizinische Hochschule Hannover, the Medical University of Warsaw, EC Research UZ Leuven and the Swedish ethical review authority. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the study.
TRIAL REGISTRATION NUMBER


NCT04769037.",2021,Infants are randomised 1:1 to daily administration of  B. infantis  EVC001 or placebo until age 12 months and followed for a maximum of 5.5 years thereafter.,"['Infants aged 7 days to 6 weeks from Germany, Poland, Belgium, UK and Sweden are eligible for study participation if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies by age 6 years as determined by genetic risk score or family history and HLA genotype', 'infantis  from age 7 days to 6 weeks until age 12 months to children with elevated genetic risk for type 1 diabetes']","['Bifidobacterium', 'placebo', 'B. infantis  EVC001 or placebo']","['insulin autoantibodies, glutamic acid decarboxylase, islet tyrosine phosphatase 2 or zinc transporter 8, (2) Diabetes, (3) Transglutaminase autoantibodies associated with coeliac disease, (4) Respiratory infection rate', 'allergy, antibody response to vaccines, alterations of the gut microbiome or blood metabolome, stool pH and calprotectin', 'cumulative incidence of beta-cell autoantibodies', 'development of persistent confirmed multiple beta-cell autoantibodies']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1275890', 'cui_str': 'Anti-insulin autoantibody'}, {'cui': 'C0017785', 'cui_str': 'Glutamate decarboxylase'}, {'cui': 'C0085536', 'cui_str': 'Protein-tyrosine-phosphatase'}, {'cui': 'C4019440', 'cui_str': 'Slc30A8 Protein'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033679', 'cui_str': 'Proteinglutamine gamma-glutamyltransferase'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",,0.580149,Infants are randomised 1:1 to daily administration of  B. infantis  EVC001 or placebo until age 12 months and followed for a maximum of 5.5 years thereafter.,"[{'ForeName': 'Anette-Gabriele', 'Initials': 'AG', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany anette-g.ziegler@helmholtz-muenchen.de.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Arnolds', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Kölln', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Achenbach', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Berner', 'Affiliation': 'Department of Pediatrics, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Bonifacio', 'Affiliation': 'Center for Regenerative Therapies Dresden (CRTD), Faculty of Medicine, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Casteels', 'Affiliation': 'Department of Pedriatrics, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Elding Larsson', 'Affiliation': 'Department of Paediatrics, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Gündert', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kordonouri', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Lundgren', 'Affiliation': 'Department of Paediatrics, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Oltarzewski', 'Affiliation': 'Institute of Mother and Child, Warszawa, Poland.'}, {'ForeName': 'Marcin L', 'Initials': 'ML', 'LastName': 'Pekalski', 'Affiliation': 'Wellcome Centre for Human Genetics, Nuffield Department of Medicine, NIHR Biomedical Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pfirrmann', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szypowska', 'Affiliation': 'Department of Paediatrics, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Todd', 'Affiliation': 'Wellcome Centre for Human Genetics, Nuffield Department of Medicine, NIHR Biomedical Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-052449']
2598,34753752,Health providers' experiences with mental health specialist video consultations in primary care: a qualitative study nested within a randomised feasibility trial.,"OBJECTIVE


Despite available effective treatments for mental health disorders, few patients in need receive even the most basic care. Integrated telepsychiatry services may be a viable option to increase access to mental healthcare. The aim of this qualitative process evaluation embedded in a randomised controlled feasibility trial was to explore health providers' experiences with a mental healthcare model integrating mental health specialist video consultations (MHSVC) and primary care.
METHODS


A qualitative process evaluation focusing on MHSVC in primary care was conducted. In 13 semistructured interviews, we assessed the experience of all mental health specialists, primary care physicians and medical assistants who participated in the trial. A thematic analysis, focusing on the implementation, mechanisms of impact and context, was applied to investigate the data.
RESULTS


Considering (1) the implementation, participants evaluated the consultations as feasible, easy to use and time saving. Concerning (2) the mechanisms of impact, the consultations were regarded as effective for patients. Providers attributed the patients' improvements to two key aspects: the familiarity of the primary care practice and the fast access to specialist mental healthcare. Mental health specialists observed trustful therapeutic alliances emerging and described their experience as comparable to same-room care. However, compared with same-room care, specialists perceived the video consultations as more challenging and sometimes more exhausting due to the additional effort required for establishing therapeutic alliances. Regarding (3) the intervention's context, shorter travel distances for patients positively affected the implementation, while technical failures, that is, poor Internet connectivity, emerged as the main barrier.
CONCLUSIONS


MHSVCs in primary care are feasible and successful in improving access to mental healthcare for patients. To optimise engagement and comfort of both patients and health providers, future work should focus on empirical determinants for establishing robust therapeutic alliances with patients receiving MHSVC (eg, leveraging non-verbal cues for therapeutic purposes).
TRIAL REGISTRATION NUMBER


DRKS00015812; Results.",2021,"Regarding (3) the intervention's context, shorter travel distances for patients positively affected the implementation, while technical failures, that is, poor Internet connectivity, emerged as the main barrier.
","[""Health providers' experiences with mental health specialist video consultations in primary care"", '13 semistructured interviews, we assessed the experience of all mental health specialists, primary care physicians and medical assistants who participated in the trial']",['mental healthcare model integrating mental health specialist video consultations (MHSVC) and primary care'],[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0334914', 'cui_str': 'Medical assistant'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],,0.037903,"Regarding (3) the intervention's context, shorter travel distances for patients positively affected the implementation, while technical failures, that is, poor Internet connectivity, emerged as the main barrier.
","[{'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Haun', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Heidelberg University, Heidelberg, Baden-Württemberg, Germany markus.haun@med.uni-heidelberg.de.'}, {'ForeName': 'Mariell', 'Initials': 'M', 'LastName': 'Hoffmann', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Heidelberg University, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Wildenauer', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Heidelberg University, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Justus', 'Initials': 'J', 'LastName': 'Tönnies', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Heidelberg University, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Szecsenyi', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Peters-Klimm', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Kronsteiner', 'Affiliation': 'Institute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Mechthild', 'Initials': 'M', 'LastName': 'Hartmann', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Heidelberg University, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Friederich', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Heidelberg University, Heidelberg, Baden-Württemberg, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-047829']
2599,34753703,"EGFR High Copy Number Together With High EGFR Protein Expression Predicts Improved Outcome for Cetuximab-based Therapy in Squamous Cell Lung Cancer: Analysis From SWOG S0819, a Phase III Trial of Chemotherapy With or Without Cetuximab in Advanced NSCLC.","BACKGROUND


The phase III S0819 trial investigated addition of cetuximab to first-line chemotherapy (CT) in NSCLC. Subgroup analyses suggested an OS benefit among patients with EGFR copy number gain in squamous cell carcinomas (SCC), (HR = 0.58 [0.39-0.86], P = .0071). A more detailed model based on EGFR FISH, EGFR IHC and KRAS mutation status was evaluated to yield a more precise predictive paradigm of cetuximab-based therapy in advanced NSCLC.
METHODS


FISH was performed using the Colorado Scoring Criteria; H-Score was used to quantify EGFR IHC expression (cut-off ≥ 200). A Cox model was used to assess treatment effects for OS and PFS within biomarker and clinical subgroups. KRAS mutation was analyzed using Therascreen. The false discovery rate controlled for multiple comparisons. S0819 ClinicalTrials.gov Identifier: NCT00946712.
RESULTS


Of 1,313 eligible patients, assay results were obtained for FISH on 976 patients (41% positive), for IHC on 945 patients (31% positive), and KRAS mutation status on 627 patients (26% positive). In SCC patients, OS was significantly improved with addition of cetuximab when both EGFR FISH and EGFR IHC were positive (N = 58), (OS HR: 0.32 [95% CI 0.18-0.59]; P = .0002, q = 0.08), median 12.6 versus 4.6 months. The results were independent of KRAS mutation status. In Non-SCC, no predictive value of EGFR IHC, EGFR FISH status and/or KRAS status was seen.
CONCLUSIONS


In NSCLC SCC, a combination index of EGFR FISH plus EGFR IHC results was associated with improved OS when cetuximab was added to CT, representing a potential predictive molecular paradigm for patients suitable for EGFR-antibody therapy.",2021,"In Non-SCC, no predictive value of EGFR IHC, EGFR FISH status","['Squamous Cell Lung Cancer', '1,313 eligible patients', 'Advanced NSCLC']","['Cetuximab-based Therapy', 'cetuximab to first-line chemotherapy (CT']","['EGFR IHC, EGFR FISH status', 'EGFR High Copy Number', 'EGFR IHC expression']","[{'cui': 'C0149782', 'cui_str': 'Squamous cell carcinoma of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",1313.0,0.107154,"In Non-SCC, no predictive value of EGFR IHC, EGFR FISH status","[{'ForeName': 'Fred R', 'Initials': 'FR', 'LastName': 'Hirsch', 'Affiliation': 'Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO; Center for Thoracic Oncology, Tisch Cancer Institute, Mount Sinai Health System, New York City, NY. Electronic address: fred.hirsch@mssm.edu.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Redman', 'Affiliation': 'SWOG Statistical Center and Clinical Biostatistics, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'SWOG Statistical Center and Clinical Biostatistics, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Agustoni', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Semrad', 'Affiliation': 'University of California at Davis, Sacramento, CA.'}, {'ForeName': 'Marileila', 'Initials': 'M', 'LastName': 'Varella-Garcia', 'Affiliation': 'Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Rivard', 'Affiliation': 'Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'University of California at Davis, Sacramento, CA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'University of California at Davis, Sacramento, CA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Mack', 'Affiliation': 'Center for Thoracic Oncology, Tisch Cancer Institute, Mount Sinai Health System, New York City, NY; University of California at Davis, Sacramento, CA.'}]",Clinical lung cancer,['10.1016/j.cllc.2021.10.002']
2600,34753667,Effectiveness of a school-based intervention on physical activity and screen time among adolescents.,"OBJECTIVES


To evaluate the effectiveness of a multi-component school-based intervention on physical activity (PA) and screen time (ST) among urban adolescents in Bangladesh.
DESIGN


Cluster-randomised controlled trial.
METHODS


Eight high schools were randomly assigned to either intervention group (IG) or control group (CG). Participants (n = 160 per group, 40 school) were in grades 8-9. A 12-week multi-component intervention was developed based on the WHO's Health-Promoting Schools framework. The IG received weekly supervised circuit exercise (30 min/week), health education session (10 min/week) with health educational materials, and lunchtime sports activities (20 min/week). The main outcome measures included self-reported PA, ST, knowledge on PA and SB, which were assessed at baseline, 8 and 12 weeks. Repeated measures ANCOVA was used to evaluate the intervention effects.
RESULTS


Total PA (MET-min/week) was increased from baseline to 8 and 12 weeks in the IG (3%-5%) but decreased in the CG (5%-3%) and significantly improved in the IG compared to the CG (p < 0.001) over time. Average ST (min/day) reduced from baseline to 8 and 12 weeks in the IG (28%-35%), while remained unchanged in the CG (6%-5%). The IG had a significantly lower average ST than the CG at 12 weeks. The average knowledge scores on PA and SB were significantly higher in the IG than the CG at 12 weeks (p < 0.001).
CONCLUSIONS


Our intervention has demonstrated some promising effects on increasing PA, reducing ST, and improving PA and SB knowledge. This study underscores the need for a scaled-up evaluation in other locations including rural settings.",2021,"The average knowledge scores on PA and SB were significantly higher in the IG than the CG at 12 weeks (p < 0.001).
","['Participants (n\u202f=\u202f160 per group, 40 school) were in grades 8-9', 'adolescents', 'Eight high schools', 'urban adolescents in Bangladesh']","['school-based intervention', 'multi-component school-based intervention', 'supervised circuit exercise (30\u202fmin/week), health education session (10\u202fmin/week) with health educational materials, and lunchtime sports activities', 'intervention group (IG) or control group (CG']","['Average ST', 'self-reported PA, ST, knowledge on PA and SB', 'average ST', 'physical activity (PA) and screen time (ST', 'physical activity and screen time', 'average knowledge scores on PA and SB']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0585039', 'cui_str': 'Lunch time'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",8.0,0.0343921,"The average knowledge scores on PA and SB were significantly higher in the IG than the CG at 12 weeks (p < 0.001).
","[{'ForeName': 'Kazi Rumana', 'Initials': 'KR', 'LastName': 'Ahmed', 'Affiliation': 'School of Health & Rehabilitation Sciences, The University of Queensland, Australia. Electronic address: k.ahmed@uqconnect.edu.au.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Kolbe-Alexander', 'Affiliation': 'School of Health and Wellbeing, University of Southern Queensland, Australia; School of Human Movement and Nutrition Sciences, The University of Queensland, Australia; Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, South Africa. Electronic address: tracy.kolbe-alexander@usq.edu.au.'}, {'ForeName': 'Asaduzzaman', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'School of Health & Rehabilitation Sciences, The University of Queensland, Australia. Electronic address: a.khan2@uq.edu.au.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2021.10.007']
2601,34753654,Impact of High-Frequency Oscillatory Ventilation Combined With Volume Guarantee on Lung Inflammatory Response in Infants With Acute Respiratory Distress Syndrome After Congenital Heart Surgery: A Randomized Controlled Trial.,"OBJECTIVES


Congenital heart disease (CHD) after cardiopulmonary bypass can cause systemic inflammation, and its degree is closely related to the incidence of acute respiratory distress syndrome (ARDS). The purpose of this study was to determine the effectiveness of high-frequency oscillatory ventilation (HFOV) combined with volume guarantee (VG) in reducing systemic inflammation in infants with ARDS after cardiopulmonary bypass for congenital heart surgery.
DESIGN


A randomized controlled trial.
SETTING


Single-center study in a tertiary teaching hospital.
PARTICIPANTS


A total of 58 infants with ARDS after congenital heart surgery were eligible and were randomized to the HFOV (n = 29) or the HFOV-VG (n = 29) between January 2020 and January 2021.
INTERVENTIONS


Tracheal aspirate samples for the measurement of interleukin (IL)-6, IL-8, and tumor necrosis factor-α (TNF-α) were obtained on days one, two, and three of HFOV or HFOV-VG ventilation.
MEASUREMENTS AND MAIN RESULTS


The authors found a significantly increasing trend in the HFOV group mean values of IL-6, IL-8, and TNF-α (p < 0.05 on days two and three v day one), and IL-6, IL-8, and TNF-α levels were significantly higher on day three in the HFOV group versus the HFOV+VG group (p < 0.05). In addition, the incidences of hypocapnia and hypercapnia in infants supported with HFOV-VG were significantly lower (p < 0.05). Furthermore, the postoperative mechanical ventilation duration in the HFOV-VG group also was shorter than that in the HFOV group (p < 0.05).
CONCLUSION


Compared with HFOV alone, HFOV-VG reduced proinflammatory systemic reactions after congenital cardiac surgery, decreased the incidences of hypercapnia and hypocapnia, and shortened the postoperative mechanical ventilation duration.",2021,"Compared with HFOV alone, HFOV-VG reduced proinflammatory systemic reactions after congenital cardiac surgery, decreased the incidences of hypercapnia and hypocapnia, and shortened the postoperative mechanical ventilation duration.","['n = 29) between January 2020 and January 2021', 'Infants With Acute Respiratory Distress Syndrome', 'Single-center study in a tertiary teaching hospital', 'After Congenital Heart Surgery', 'A total of 58 infants with ARDS after congenital heart surgery', 'infants with ARDS after cardiopulmonary bypass for congenital heart surgery']","['HFOV', 'HFOV-VG', 'high-frequency oscillatory ventilation (HFOV) combined with volume guarantee (VG', 'HFOV alone, HFOV-VG', 'High-Frequency Oscillatory Ventilation Combined With Volume Guarantee', 'HFOV+VG']","['IL-6, IL-8, and TNF-α', 'HFOV-VG', 'proinflammatory systemic reactions', 'Lung Inflammatory Response', 'incidences of hypercapnia and hypocapnia, and shortened the postoperative mechanical ventilation duration', 'IL-6, IL-8, and TNF-α levels', 'incidences of hypocapnia and hypercapnia', 'postoperative mechanical ventilation duration']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0419017', 'cui_str': 'High frequency oscillatory ventilation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0419017', 'cui_str': 'High frequency oscillatory ventilation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0085383', 'cui_str': 'Hypocapnia'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",58.0,0.0812455,"Compared with HFOV alone, HFOV-VG reduced proinflammatory systemic reactions after congenital cardiac surgery, decreased the incidences of hypercapnia and hypocapnia, and shortened the postoperative mechanical ventilation duration.","[{'ForeName': 'Yi-Rong', 'Initials': 'YR', 'LastName': 'Zheng', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Wen-Peng', 'Initials': 'WP', 'LastName': 'Xie', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Hong-Lin', 'Initials': 'HL', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China. Electronic address: chenqiang2228@163.com.""}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2021.10.012']
2602,34753640,"Aqua-Plyometric Exercises: Potential Implications for Bone Mineral Density, Functional Capacity, and Quality of Life in Survivors of Childhood Acute Lymphoblastic Leukemia.","OBJECTIVE


This study endeavored to explore the effect of an aquatic-based plyometric exercise program (Aqua-PLYO) on bone mineralization, functional capacity, and quality of life in survivors of childhood acute lymphoblastic leukemia (ALL).
DATA SOURCES


In a prospective, single-blinded quasi-experimental study, 30 survivors of childhood ALL (63.3% boys; age: 13.1 ± 2.8 years) were allocated to undergo the Aqua-PLYO exercise program (Aqua-PLYO group; n = 15) or the usual physical therapy (Control group; n = 15). Bone mineralization (bone mineral density [BMD], bone mineral content [BMC], BMD Z-score, and BMD volumetric [BMD vol ]), functional capacity, and quality of life were assessed prior to, and following 36 treatment sessions, which were undertaken over nonconsecutive days in a 12-week program. With controlling for the pretreatment values, all measures of bone mineralization, functional capacity, and quality of life showed more favorable posttreatment improvement in the Aqua-PLYO group as compared to the control group (all P < .05).
CONCLUSION


The Aqua-PLYO exercises, besides the usual physical therapy, can effectively improve bone health, increase functional capacity, and promote a better quality of life in long-term survivors of childhood ALL.
IMPLICATIONS FOR NURSING PRACTICE


Although survivors of childhood ALL experience reduced BMD, functional ability, and quality of life, Aqua-PLYO exercises can have positive effects on survivors' physical and functional disturbances and can, even more, be enjoyable and increase their motivation and interest in engaging in exercise interventions.",2021,"With controlling for the pretreatment values, all measures of bone mineralization, functional capacity, and quality of life showed more favorable posttreatment improvement in the Aqua-PLYO group as compared to the control group (all P < .05).
","['Survivors of Childhood Acute Lymphoblastic Leukemia', 'survivors of childhood acute lymphoblastic leukemia (ALL', '30 survivors of childhood ALL (63.3% boys; age: 13.1 ± 2.8 years']","['aquatic-based plyometric exercise program (Aqua-PLYO', 'Aqua-Plyometric Exercises', 'Aqua-PLYO exercise program (Aqua-PLYO group; n\u202f=\u202f15) or the usual physical therapy (Control group; n\u202f=\u202f15']","['quality of life', 'bone mineralization, functional capacity, and quality of life', 'Bone Mineral Density, Functional Capacity, and Quality of Life', 'BMD, functional ability, and quality of life, Aqua-PLYO exercises', 'bone health, increase functional capacity', 'Bone mineralization (bone mineral density [BMD], bone mineral content [BMC], BMD Z-score, and BMD volumetric [BMD vol ]), functional capacity, and quality of life']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0023452', 'cui_str': 'Lymphoblastic Leukemia, Acute, Childhood'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2350989', 'cui_str': 'Bone Mineralization'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0104323,"With controlling for the pretreatment values, all measures of bone mineralization, functional capacity, and quality of life showed more favorable posttreatment improvement in the Aqua-PLYO group as compared to the control group (all P < .05).
","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia; Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt. Electronic address: rke_pt2001@yahoo.com.'}, {'ForeName': 'Rania R', 'Initials': 'RR', 'LastName': 'Mohamed', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Seminars in oncology nursing,['10.1016/j.soncn.2021.151225']
2603,34753612,Adaptive web-based stress management programs among adults with a cardiovascular disease: A pilot Sequential Multiple Assignment Randomized Trial (SMART).,"OBJECTIVE


To assess the feasibility and acceptability of using a Sequential Multiple Assignment Randomized Trial (SMART) to optimize the delivery of a web-based, stress management intervention for patients with a cardiovascular disease (CVD).
METHODS


59 patients with a CVD and moderate stress were randomized to a self-directed web-based stress management program (n = 30) or the same intervention plus lay telephone coaching (n = 29). After 6 weeks, non-responders were re-randomized to continue with their initial intervention or switched to motivational interviewing (MI). Feasibility, acceptability, and clinical significance were assessed.
RESULTS


SMART procedures were feasible. Attrition rates were almost twice as high in the web-only group than the lay coach group. This might be because of the low satisfaction (47%) in the web-only group. On average, 1.7/5 modules were completed. Effect sizes for stress and quality of life generally exceeded 0.2 (clinical benchmark), except for the group that initially received lay coaching and then switched to MI.
CONCLUSIONS


Results suggest that a larger trial would be feasible. Issues pertaining to attrition and satisfaction for non-responders need to be addressed.
PRACTICE IMPLICATIONS


Findings contribute to the evidence on how best to develop and deliver e-Health interventions to maximize their efficacy while remaining cost-effective.",2021,"Effect sizes for stress and quality of life generally exceeded 0.2 (clinical benchmark), except for the group that initially received lay coaching and then switched to MI.
","['patients with a cardiovascular disease (CVD', 'adults with a cardiovascular disease', '59 patients with a CVD and moderate stress']","['Adaptive web-based stress management programs', 'self-directed web-based stress management program (n\xa0=\xa030) or the same intervention plus lay telephone coaching', 'initial intervention or switched to motivational interviewing (MI']","['Attrition rates', 'Feasibility, acceptability, and clinical significance', 'feasibility and acceptability', 'stress and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",59.0,0.020667,"Effect sizes for stress and quality of life generally exceeded 0.2 (clinical benchmark), except for the group that initially received lay coaching and then switched to MI.
","[{'ForeName': 'Sylvie D', 'Initials': 'SD', 'LastName': 'Lambert', 'Affiliation': ""Ingram School of Nursing, McGill University, 80 Sherbrooke St W, Suite 1800, Montreal, Quebec, Canada\xa0H3A 2M7; St. Mary's Research Centre, 3830 Lacombe Ave., Hayes Pavilion, Suite 4720, Montreal, Quebec, Canada\xa0H3T 1M5. Electronic address: sylvie.lambert@mcgill.ca.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Grover', 'Affiliation': 'Department of Medicine, McGill University, 845 Rue Sherbrooke St W, Montreal, Quebec, Canada H3A 0G4.'}, {'ForeName': 'Andrea Maria', 'Initials': 'AM', 'LastName': 'Laizner', 'Affiliation': 'Ingram School of Nursing, McGill University, 80 Sherbrooke St W, Suite 1800, Montreal, Quebec, Canada\xa0H3A 2M7; McGill University Health Centre, 1001 Decarie Blvd, Montreal, Quebec, Canada\xa0H4A 3J1; Research Institute of the McGill University Health Centre, 2155 Guy St, Suite 500, Montreal, Quebec, Canada\xa0H3H 2R9.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McCusker', 'Affiliation': ""St. Mary's Research Centre, 3830 Lacombe Ave., Hayes Pavilion, Suite 4720, Montreal, Quebec, Canada\xa0H3T 1M5; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, 1020 Pine Ave, Montreal, Quebec, Canada\xa0H3A 1A2.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Belzile', 'Affiliation': ""St. Mary's Research Centre, 3830 Lacombe Ave., Hayes Pavilion, Suite 4720, Montreal, Quebec, Canada\xa0H3T 1M5; Montreal West Island Integrated University Health and Social Services Centre (CIUSSS-ODIM), 3830 Lacombe Ave., Montreal, Quebec, Canada H3T 1M5.""}, {'ForeName': 'Erica E M', 'Initials': 'EEM', 'LastName': 'Moodie', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, 1020 Pine Ave, Montreal, Quebec, Canada\xa0H3A 1A2.'}, {'ForeName': 'John William', 'Initials': 'JW', 'LastName': 'Kayser', 'Affiliation': 'Montreal West Island Integrated University Health and Social Services Centre (CIUSSS-ODIM), 3830 Lacombe Ave., Montreal, Quebec, Canada H3T 1M5.'}, {'ForeName': 'Ilka', 'Initials': 'I', 'LastName': 'Lowensteyn', 'Affiliation': 'Clinimetrica, 430 Saint-Pierre St, Suite 200, Montreal, Quebec, Canada\xa0H2Y 2M5; Research Institute of the McGill University Health Centre, 2155 Guy St, Suite 500, Montreal, Quebec, Canada\xa0H3H 2R9.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vallis', 'Affiliation': 'Department of Family Medicine, Dalhousie University, 1465 Brenton St, Suite 402, Halifax, Nova Scotia, Canada\xa0B3J 3T4.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': ""Division of Cardiology, St Mary's Hospital Centre, 3830 Lacombe Ave., Montreal, Quebec, Canada\xa0H3T 1M5.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Da Costa', 'Affiliation': 'Center for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre,\xa02155 Guy St, Suite 500, Montreal, Quebec, Canada\xa0H3H 2R9; Department of Medicine, McGill University, 845 Rue Sherbrooke St W, Montreal, Quebec, Canada H3A 0G4.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Pilote', 'Affiliation': 'Center for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre,\xa02155 Guy St, Suite 500, Montreal, Quebec, Canada\xa0H3H 2R9; Department of Medicine, McGill University, 845 Rue Sherbrooke St W, Montreal, Quebec, Canada H3A 0G4.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Ibberson', 'Affiliation': ""St. Mary's Research Centre, 3830 Lacombe Ave., Hayes Pavilion, Suite 4720, Montreal, Quebec, Canada\xa0H3T 1M5.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Sabetti', 'Affiliation': ""St. Mary's Research Centre, 3830 Lacombe Ave., Hayes Pavilion, Suite 4720, Montreal, Quebec, Canada\xa0H3T 1M5.""}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'de Raad', 'Affiliation': ""St. Mary's Research Centre, 3830 Lacombe Ave., Hayes Pavilion, Suite 4720, Montreal, Quebec, Canada\xa0H3T 1M5; Montreal West Island Integrated University Health and Social Services Centre (CIUSSS-ODIM), 3830 Lacombe Ave., Montreal, Quebec, Canada H3T 1M5.""}]",Patient education and counseling,['10.1016/j.pec.2021.10.020']
2604,34753557,Serum interleukin-6 levels predict kidney disease progression in diabetic nephropathy.,"BACKGROUND


Inflammation is a main mechanism for the pathogenesis and progression of diabetic kidney disease (DKD). Interleukin-6 (IL-6) is an important inflammatory mediator that is suggested to be involved in the pathogenesis of DKD. The aim of our study was to evaluate the association between IL-6 levels and progression of DKD in patients with type 2 diabetes mellitus. Materials an methods: IL-6 levels were measured at baseline and after 4 and 12 months in 70 patients included in a multi-center, randomized controlled clinical trial designed to compare the effect of RAS blockers in monotherapy to dual blockade for slowing the progression of DKD. The primary composite endpoint was > 50% increase in baseline serum creatinine, end-stage kidney disease (ESKD), or death.
RESULTS


The median follow-up was 36 months, during which 27 patients (38.6%) reached the primary endpoint. Baseline IL-6 levels correlated with TNF-α, C-reactive protein, and PTH levels. Survival analysis showed that patients with the highest IL-6 levels (> 4.84 pg/mL) reached the primary endpoint faster than the other two groups. Multivariate Cox regression analysis showed that baseline IL-6 levels > 4.84 pg/mL (HR 4.10, 95% CI 1.36 - 12.31) were a risk factor for reaching the primary endpoint adjusted for eGFR and proteinuria. Generalized linear mixed model analysis showed no effect on subsequent IL-6 levels either with RAS blockade monotherapy or dual blockade.
CONCLUSION


These results suggest that treatment with RAS blockade does not influence IL-6 levels. IL-6 is independently associated with an increased risk for progression of DKD.",2021,"Multivariate Cox regression analysis showed that baseline IL-6 levels > 4.84 pg/mL (HR 4.10, 95% CI 1.36 - 12.31) were a risk factor for reaching the primary endpoint adjusted for eGFR and proteinuria.","['diabetic nephropathy', 'patients with type 2 diabetes mellitus']","['RAS blockers', 'RAS blockade']","['subsequent IL-6 levels', 'Interleukin-6 (IL-6', 'IL-6 levels and progression of DKD', 'IL-6 levels', 'baseline serum creatinine, end-stage kidney disease (ESKD), or death', 'Baseline IL-6 levels correlated with TNF-α, C-reactive protein, and PTH levels']","[{'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]",,0.323699,"Multivariate Cox regression analysis showed that baseline IL-6 levels > 4.84 pg/mL (HR 4.10, 95% CI 1.36 - 12.31) were a risk factor for reaching the primary endpoint adjusted for eGFR and proteinuria.","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Sanchez-Alamo', 'Affiliation': ''}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Shabaka', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cachofeiro', 'Affiliation': ''}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Cases-Corona', 'Affiliation': ''}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Fernandez-Juarez', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical nephrology,['10.5414/CN110223']
2605,34753541,Effect of probiotics combined with applied behavior analysis in the treatment of children with autism spectrum disorder: a prospective randomized controlled trial.,"OBJECTIVES


To study the effect of probiotics combined with applied behavior analysis (ABA) in the treatment of children with autism spectrum disorder (ASD).
METHODS


A total of 41 children with ASD who attended the Affiliated Hospital of Jiangsu University from May 2019 to December 2020 were enrolled and randomly divided into an observation group with 21 children and a control group with 20 children. The children in the observation group were given oral probiotics combined with ABA intervention, while those in the control group were given ABA intervention alone. The treatment outcomes were compared between the two groups. Autism Treatment Evaluation Checklist (ATEC) was used to evaluate the severity of behavioral symptoms in both groups before intervention and at 3 months after intervention. The fecal samples were collected to analyze the difference in intestinal flora between the two groups based on 16s rRNA high-throughput sequencing.
RESULTS


Before intervention, there was no significant difference in the ATEC score between the observation and control groups ( P >0.05). At 3 months after intervention, both groups had a significant reduction in the ATEC score, and the observation group had a significantly lower ATEC score than the control group ( P <0.05). Before intervention, there was no significant difference in the composition of intestinal flora between the observation and control groups. At 3 months after intervention, there was a significant difference in the composition of intestinal flora between the observation and control groups. Compared with the control group, the observation group had significantly higher relative abundances of  Bifidobacterium ,  Lactobacillus ,  Coprobacillus ,  Ruminococcus ,  Prevotella , and  Blautia  ( P <0.05) and significantly lower relative abundances of  Shigella  and  Clostridium  ( P <0.05).
CONCLUSIONS


Probiotics may improve the effect of conventional ABA intervention in children with ASD by regulating intestinal flora.",2021,"At 3 months after intervention, there was a significant difference in the composition of intestinal flora between the observation and control groups.","['children with ASD by regulating intestinal flora', '41 children with ASD who attended the Affiliated Hospital of Jiangsu University from May 2019 to December 2020 were enrolled and randomly divided into an observation group with 21 children and a control group with 20 children', 'children with autism spectrum disorder', 'children with autism spectrum disorder (ASD']","['ABA intervention alone', 'oral probiotics combined with ABA intervention', 'probiotics combined with applied behavior analysis (ABA', 'conventional ABA intervention', 'probiotics combined with applied behavior analysis']","['severity of behavioral symptoms', 'relative abundances of  Bifidobacterium ,  Lactobacillus ,  Coprobacillus ,  Ruminococcus ,  Prevotella , and  Blautia', 'ATEC score', 'composition of intestinal flora', 'relative abundances of  Shigella  and  Clostridium']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4277701', 'cui_str': 'Applied Behavior Analysis'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C1046489', 'cui_str': 'Genus Coprobacillus'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C2658870', 'cui_str': 'Blautia'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0557980', 'cui_str': 'Evaluating interventions'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0013371', 'cui_str': 'Infection by Shigella'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}]",41.0,0.0257383,"At 3 months after intervention, there was a significant difference in the composition of intestinal flora between the observation and control groups.","[{'ForeName': 'Yu-Qin', 'Initials': 'YQ', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu 212001, China (Email: yqli1314@163. com).'}, {'ForeName': 'Ying-Hong', 'Initials': 'YH', 'LastName': 'Sun', 'Affiliation': 'Department of Pediatrics, Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu 212001, China (Email: yqli1314@163. com).'}, {'ForeName': 'Ya-Peng', 'Initials': 'YP', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Pediatrics, Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu 212001, China (Email: yqli1314@163. com).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu 212001, China (Email: yqli1314@163. com).'}, {'ForeName': 'Sheng-Li', 'Initials': 'SL', 'LastName': 'Jin', 'Affiliation': 'Department of Pediatrics, Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu 212001, China (Email: yqli1314@163. com).'}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,['10.7499/j.issn.1008-8830.2108085']
2606,34753540,Effect of different maintenance doses of caffeine citrate on ventilator weaning in very preterm infants with respiratory distress syndrome: a prospective randomized controlled trial.,"OBJECTIVES


To study the effect of different maintenance doses of caffeine citrate on the success rate of ventilator weaning in very preterm infants (gestational age of ≤32 weeks) with respiratory distress syndrome (RDS).
METHODS


A total of 162 preterm infants with RDS who were admitted to the hospital from January 2016 to December 2018 were enrolled in this prospective trial. These infants had a gestational age of ≤32 weeks and required invasive mechanical ventilation. They were randomly divided into a high-dose caffeine group and a low-dose caffeine group, with 81 infants in each group. Within 6 hours after birth, both groups were given caffeine at a dose of 20 mg/kg. After 24 hours, the high- and low-dose caffeine groups were given caffeine at a maintenance dose of 10 mg/kg and 5 mg/kg, respectively. The two groups were compared in terms of re-intubation rate within 48 hours after ventilator weaning, durations of ventilation and oxygen therapy, enteral feeding, weight gain, and the incidence rates of complications and adverse reactions during hospitalization.
RESULTS


The high-dose caffeine group had a significantly lower re-intubation rate within 48 hours after ventilator weaning than the low-dose caffeine group ( P <0.05), with frequent apnea as the main reason for failed ventilator weaning in both groups. The high-dose caffeine group had significantly shorter durations of mechanical ventilation and oxygen therapy than the low-dose caffeine group ( P <0.05). There were no significant differences between the two groups in the time to total enteral feeding, average daily weight gain, body weight at discharge, and the incidence rates of complications (bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intracranial hemorrhage) and adverse reactions (tachycardia, hypertension, and feeding intolerance) ( P >0.05).
CONCLUSIONS


A high maintenance dose of caffeine can safely and effectively reduce the incidence rate of apnea after ventilator weaning and the failure rate of ventilator weaning in RDS preterm infants with a gestational age of ≤32 weeks, and therefore, it holds promise for clinical application.",2021,The high-dose caffeine group had significantly shorter durations of mechanical ventilation and oxygen therapy than the low-dose caffeine group ( P <0.05).,"['162 preterm infants with RDS who were admitted to the hospital from January 2016 to December 2018', 'infants had a gestational age of ≤32 weeks and required invasive mechanical ventilation', 'RDS preterm infants with a gestational age of ≤32 weeks', 'very preterm infants with respiratory distress syndrome', 'very preterm infants (gestational age of ≤32 weeks) with respiratory distress syndrome (RDS']","['caffeine', 'caffeine group and a low-dose caffeine', 'caffeine citrate']","['shorter durations of mechanical ventilation and oxygen therapy', 'success rate of ventilator weaning', 'time to total enteral feeding, average daily weight gain, body weight at discharge, and the incidence rates of complications (bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intracranial hemorrhage) and adverse reactions (tachycardia, hypertension, and feeding intolerance', 're-intubation rate', 'durations of ventilation and oxygen therapy, enteral feeding, weight gain, and the incidence rates of complications and adverse reactions during hospitalization', 'incidence rate of apnea']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0054436', 'cui_str': 'Caffeine citrate'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}]",162.0,0.0274233,The high-dose caffeine group had significantly shorter durations of mechanical ventilation and oxygen therapy than the low-dose caffeine group ( P <0.05).,"[{'ForeName': 'Xiao-Lan', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': ""Department of Child Health Care, Guangzhou Women and Children's Medical Center, Guangzhou 510623, China.""}, {'ForeName': 'Yue-Ju', 'Initials': 'YJ', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiao-Wen', 'Initials': 'XW', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Song', 'Affiliation': ""Department of Child Health Care, Guangzhou Women and Children's Medical Center, Guangzhou 510623, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,['10.7499/j.issn.1008-8830.2107167']
2607,34753536,Analgesic Efficacy of Tramadol and Morphine in White's Tree Frogs (Litoria caerulea).,"Published data are sparse regarding the recognition of clinically relevant pain and appropriate analgesia in amphibians. The amphibian analgesia literature has primarily focused on nociceptive pathways in a single species, the northern leopard frog (Rana pipiens). The objective of the current study was to assess the analgesic efficacy and safety of oral tramadol and subcutaneous morphine in a commonly maintained zoo and pet species, White's tree frog (Litoria caerulea). We hypothesized that tramadol and morphine would provide dose-dependent antinociception, as measured by significant increases in hindlimb withdrawal latency after exposure to a noxious thermal stimulus. Two randomized, placebo-controlled, complete crossover studies were performed, with tramadol (n = 12) administered at 15, 25, and 40 mg/kg PO and morphine (n = 12) administered at 5 and 10 mg/kg SC. Hindlimb withdrawal latency was measured for a maximum of 72 h. No adverse side effects or signs of sedation were observed with any dose or drug evaluated. No significant difference in withdrawal latency was detectedbetween the control and either tramadol or morphine. These negative results were surprising, suggesting that the thermalnociceptive model may not be biologically relevant in amphibian species.",2021,No adverse side effects or signs of sedation were observed with any dose or drug evaluated.,"[""White's Tree Frogs (Litoria caerulea""]","['Tramadol and Morphine', 'tramadol and morphine', 'tramadol', 'placebo', 'morphine', 'oral tramadol and subcutaneous morphine']","['hindlimb withdrawal latency', 'analgesic efficacy and safety', 'adverse side effects or signs of sedation', 'withdrawal latency', 'Hindlimb withdrawal latency', 'Analgesic Efficacy']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0327058', 'cui_str': 'Treefrog'}, {'cui': 'C0327066', 'cui_str': 'Litoria caerulea'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]",,0.113191,No adverse side effects or signs of sedation were observed with any dose or drug evaluated.,"[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Hausmann', 'Affiliation': ''}, {'ForeName': 'Ashley R', 'Initials': 'AR', 'LastName': 'Krisp', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mans', 'Affiliation': ''}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Kurt K', 'Initials': 'KK', 'LastName': 'Sladky', 'Affiliation': ''}]",Journal of the American Association for Laboratory Animal Science : JAALAS,['10.30802/AALAS-JAALAS-21-000009']
2608,34753535,Evaluation of the ocular safety associated with the exhalation delivery system with fluticasone.,"BACKGROUND


Intranasal corticosteroids (INCS) are the cornerstone of treatment for chronic rhinosinusitis. Although INCS are generally considered safe and effective, there is a concern that chronic use may lead to ocular adverse effects.
OBJECTIVE


To assess ocular safety of the exhalation delivery system with fluticasone propionate (EDS-FLU) in patients with chronic rhinosinusitis with nasal polyps.
METHODS


Ocular safety data were collected during two randomized, double-blind, placebo controlled studies with open label extensions. Ophthalmologists performed tonometry, slit-lamp, and visual acuity examinations to assess intraocular pressure (IOP) and the presence of cataracts. Ocular examinations were conducted before double-blind treatment, at the end of the 16-week double-blind phase, and at the end of the 8-week open-label phase. The results of pooled data from patients who received EDS-FLU 186 mcg (n = 160), EDS-FLU 372 mcg (n = 161), and EDS-placebo (n = 161) twice daily are reported here.
RESULTS


At the end of the double-blind phase, six patients developed elevated average IOP > 21 mm Hg: two patients(1.2%) in the EDS-placebo group, three patients (1.9%) in the EDS-FLU 186 mcg group, and one patient (0.6%) in the EDSFLU 372 mcg group. In addition, 6 of 482 patients developed cataracts: 3 patients in the EDS-placebo group, 2 patients in the EDS-FLU 186 mg group, and 1 patient in the EDS-FLU 372 mg group. At the end of the open-label phase, two additional patients showed IOP > 21 mm Hg and two additional patients developed cataracts.
CONCLUSION


No increased risk of elevated IOP was detected with EDS-FLU; the rate of cataract development was similar to EDS-placebo and to that reported with other INCS.",2021,No increased risk of elevated IOP was detected with EDS-FLU; the rate of cataract development was similar to EDS-placebo and to that reported with other INCS.,"['chronic rhinosinusitis', 'patients with chronic rhinosinusitis with nasal polyps', '482 patients developed cataracts: 3 patients in the EDS']","['fluticasone propionate (EDS-FLU', 'Ophthalmologists performed tonometry, slit-lamp, and visual acuity examinations', 'Intranasal corticosteroids (INCS', 'EDS-placebo', 'INCS', 'fluticasone', 'placebo']","['cataracts', 'intraocular pressure (IOP', 'risk of elevated IOP', 'rate of cataract development', 'elevated average IOP ']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}]","[{'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0183355', 'cui_str': 'Slit lamp biomicroscope'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}]","[{'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.666789,No increased risk of elevated IOP was detected with EDS-FLU; the rate of cataract development was similar to EDS-placebo and to that reported with other INCS.,"[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Skoner', 'Affiliation': ''}, {'ForeName': 'Eli O', 'Initials': 'EO', 'LastName': 'Meltzer', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Skoner', 'Affiliation': ''}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Sacks', 'Affiliation': ''}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': ''}]",Allergy and asthma proceedings,['10.2500/aap.2022.43.210096']
2609,34754004,Pharmacists' interventions improve health-related quality of life of rural older person on warfarin: a randomized controlled trial.,"Warfarin therapy can significantly affect patients' quality of life and cause therapy discontinuation. This study aimed to investigate the effect of the pharmacists' interventions on the health-related quality of life (HRQoL) in older rural patients on warfarin therapy. Eligible older patients from rural area of Croatian province Slavonia were randomized into the intervention and control groups and followed for six months. Repeated education and a follow-up plan were provided to the participants in the intervention group, and if needed, the pharmacist intervened to optimize warfarin therapy. Secondary analysis on HRQoL data are presented here. Main outcome measure was Duke anticoagulation satisfactions scale questionnaire score. In total, 131 participants finished the study (median age 73 years; 51.1% male). Participants in the intervention group scored significantly lower (median being 86.5 and 66.0 in the control and intervention groups, respectively; p < 0,001), indicating higher HRQoL. Adverse drug reactions and pharmacist's intervention were identified as predictive factors for patients' HRQoL (r 2  = 65.5%, P < 0.001). The study demonstrated that community pharmacist's interventions can improve HRQoL of older patients taking warfarin what is of particular significance for patients living in rural areas with less accessible healthcare and lower socio-economic status.Clinicaltrials.gov (ID: NCT03212898), 11/07/2017, retrospectively registered.",2021,"Participants in the intervention group scored significantly lower (median being 86.5 and 66.0 in the control and intervention groups, respectively; p < 0,001), indicating higher HRQoL. Adverse drug reactions and pharmacist's intervention were identified as predictive factors for patients' HRQoL (r 2  = 65.5%, P < 0.001).","['older rural patients on warfarin therapy', 'older patients taking', '131 participants finished the study (median age 73\xa0years; 51.1% male', 'Eligible older patients from rural area of Croatian province Slavonia']","[""community pharmacist's interventions"", 'warfarin', 'Warfarin therapy', 'warfarin therapy', ""pharmacists' interventions""]","[""patients' quality of life and cause therapy discontinuation"", 'health-related quality of life', 'health-related quality of life (HRQoL', 'Duke anticoagulation satisfactions scale questionnaire score']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4303340', 'cui_str': 'Warfarin therapy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0684046', 'cui_str': 'Croatian language'}]","[{'cui': 'C0402003', 'cui_str': 'Community pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C4303340', 'cui_str': 'Warfarin therapy'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",131.0,0.0626715,"Participants in the intervention group scored significantly lower (median being 86.5 and 66.0 in the control and intervention groups, respectively; p < 0,001), indicating higher HRQoL. Adverse drug reactions and pharmacist's intervention were identified as predictive factors for patients' HRQoL (r 2  = 65.5%, P < 0.001).","[{'ForeName': 'Slaven', 'Initials': 'S', 'LastName': 'Falamić', 'Affiliation': 'Pharmacy Branka Marušić, Trg Ante Starčevića 24, 31450, Donji Miholjac, Croatia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Lucijanić', 'Affiliation': 'Hematology Department, University Hospital Dubrava, Avenija Gojka Suska 6, 10000, Zagreb, Croatia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Ortner-Hadžiabdić', 'Affiliation': 'Centre for Applied Pharmacy, Faculty of Pharmacy and Biochemistry, University of Zagreb, Ante Kovačića 1, 10000, Zagreb, Croatia. mortner@pharma.hr.'}, {'ForeName': 'Srećko', 'Initials': 'S', 'LastName': 'Marušić', 'Affiliation': 'Department of Clinical Pharmacology, University Hospital Dubrava, Avenija Gojka Suska 6, 10000, Zagreb, Croatia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Bačić-Vrca', 'Affiliation': 'Department of Clinical Pharmacy, University Hospital Dubrava, Avenija Gojka Suska 6, 10000, Zagreb, Croatia.'}]",Scientific reports,['10.1038/s41598-021-01394-0']
2610,34753900,Egg and saturated fat containing breakfasts have no acute effect on acute glycemic control in healthy adults: a randomized partial crossover trial.,"BACKGROUND/OBJECTIVES


High egg consumption is associated with poor glycemic control. Considering the widespread consumption of eggs, it is crucial to determine causality in this association. We tested if egg consumption acutely alters glucose disposal in the absence or presence of saturated fat, which is frequently consumed with eggs.
SUBJECTS/METHODS


In a randomized partial crossover clinical trial, 48 subjects (consuming ≥ 1 egg/week) received two of four isocaloric, macronutrient-matched breakfasts. The groups were defined based on the main ingredient of the breakfasts offered: eggs (EB); saturated fat (SB); eggs and saturated fat (ES); and control, which included a cereal based breakfast (CB). The breakfasts were offered in two testing sessions spaced seven days apart. Six blood samples (pre breakfast (fasting); 30, 60, 90, 120, and 180 minutes post breakfast) were collected to measure glucose and insulin levels. Area under the curves (AUC) were analyzed controlling for the baseline concentrations using mixed-effects models accounting for within-subject dependencies to compare these across breakfast assignments.
RESULTS


Forty-eight patients (46% males, age 25.8 ± 7.7 years, BMI 25.7 ± 4.6 kg/m 2 ) were included. Neither EB, SB nor ES was associated with a significant difference in AUC of glucose or insulin compared to CB (p > 0.1).
CONCLUSIONS


Acutely, consumption of egg breakfast with or without accompanying saturated fat does not adversely affect glucose disposal in healthy adults. While this is reassuring for continued egg consumption, a long-term evaluation of egg intake with or without saturated fat would be the next step.",2021,"Neither EB, SB nor ES was associated with a significant difference in AUC of glucose or insulin compared to CB (p > 0.1).
","['healthy adults', '48 subjects (consuming ≥ 1 egg/week) received two of four', 'Forty-eight patients (46% males, age 25.8\u2009±\u20097.7 years, BMI 25.7\u2009±\u20094.6\u2009kg/m 2 ) were included']","['Egg and saturated fat containing breakfasts', 'breakfasts offered: eggs (EB); saturated fat (SB); eggs and saturated fat (ES); and control, which included a cereal based breakfast (CB', 'egg breakfast with or without accompanying saturated fat', 'isocaloric, macronutrient-matched breakfasts']","['acute glycemic control', 'AUC of glucose or insulin', 'glucose and insulin levels', 'glucose disposal']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",48.0,0.0619393,"Neither EB, SB nor ES was associated with a significant difference in AUC of glucose or insulin compared to CB (p > 0.1).
","[{'ForeName': 'Chathurika S', 'Initials': 'CS', 'LastName': 'Dhanasekara', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Dawson', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Binks', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Childress', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Nikhil V', 'Initials': 'NV', 'LastName': 'Dhurandhar', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX, USA. Nikhil.Dhurandhar@ttu.edu.'}]",Nutrition & diabetes,['10.1038/s41387-021-00176-x']
2611,34753859,Performance Nutrition for Physician Trainees Working Overnight Shifts: A Randomized Controlled Trial.,"PURPOSE


To compare acute effects of 2 dietary interventions with usual dietary habits on physician trainees' alertness during overnight shifts.
METHOD


This registered, controlled, block-randomized crossover trial (NCT03698123) was conducted between October 2018 and May 2019 at Stanford Medicine. Physician trainees working at least 3 overnight shifts during a 1-week period were recruited. During the first overnight shift, participants followed their usual dietary habits. During the intervention nights (low carbohydrate-to-protein ratio and high carbohydrate-to-protein ratio interventions), participants received healthy dinners, snacks, water, and, upon request, caffeinated beverages, at the beginning of their shifts and were instructed to eat meals before 10 p.m. The sequence of interventions on the second and third nights were block-randomized across study weeks. Outcome measures (a priori) were overnight changes in validated measures of specific neurobehavioral dimensions: psychomotor vigilance, sensory-motor speed, working memory, and risk decision-making, as well as self-reported sleepiness and work exhaustion.
RESULTS


Sixty-one physician trainees participated in this study. Compared to usual dietary habits, overnight changes in psychomotor vigilance scores (scale 0-1,000) improved by 51.02 points (95% confidence interval [CI]: 12.08, 89.96); sleepiness (scale 1-7) improved by 0.69 points (95% CI: 0.33, 1.05) under the low carbohydrate-to-protein ratio intervention. Compared to usual dietary habits, overnight changes in sleepiness (scale 1-7) improved by 0.61 points (95% CI: 0.25, 0.96) under the high carbohydrate-to-protein ratio intervention. Neither intervention had beneficial effects relative to usual dietary habits with respect to sensory-motor speed, working memory, risk decision-making, or work exhaustion. There were no differences in outcomes between low carbohydrate-to-protein ratio and high carbohydrate-to-protein ratio interventions.
CONCLUSIONS


Dietary interventions may mitigate negative effects of physician trainee sleep deprivation during overnight shifts. Future studies are warranted to further examine the effectiveness of nutritional strategies on physician alertness during overnight shifts.",2021,"Neither intervention had beneficial effects relative to usual dietary habits with respect to sensory-motor speed, working memory, risk decision-making, or work exhaustion.","['Sixty-one physician trainees', 'Physician trainees working at least 3 overnight shifts during a 1-week period were recruited', 'October 2018 and May 2019 at Stanford Medicine', 'Physician Trainees']","['Working Overnight Shifts', 'intervention nights (low carbohydrate-to-protein ratio and high carbohydrate-to-protein ratio interventions', '2 dietary interventions with usual dietary habits']","['specific neurobehavioral dimensions: psychomotor vigilance, sensory-motor speed, working memory, and risk decision-making, as well as self-reported sleepiness and work exhaustion', 'psychomotor vigilance scores', 'sensory-motor speed, working memory, risk decision-making, or work exhaustion']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0583218,"Neither intervention had beneficial effects relative to usual dietary habits with respect to sensory-motor speed, working memory, risk decision-making, or work exhaustion.","[{'ForeName': 'Maryam S', 'Initials': 'MS', 'LastName': 'Makowski', 'Affiliation': 'M.S. Makowski is clinical assistant professor, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0003-0823-5376. M.T. Trockel is clinical professor, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0001-7191-5791. N.K. Menon is social science research professional, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0001-6443-1561. H. Wang is a biostatistician, Stanford Medicine WellMD & WellPhD Center, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0003-4076-3443. L. Katznelson is professor of neurosurgery and medicine, Departments of Neurosurgery and Medicine, and associate dean of graduate medical education, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0001-8115-5714. T.D. Shanafelt is professor of medicine, Department of Medicine, chief wellness officer, Stanford Medicine, and associate dean, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0002-7106-5202.'}, {'ForeName': 'Mickey T', 'Initials': 'MT', 'LastName': 'Trockel', 'Affiliation': ''}, {'ForeName': 'Nikitha K', 'Initials': 'NK', 'LastName': 'Menon', 'Affiliation': ''}, {'ForeName': 'Hanhan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Katznelson', 'Affiliation': ''}, {'ForeName': 'Tait D', 'Initials': 'TD', 'LastName': 'Shanafelt', 'Affiliation': ''}]",Academic medicine : journal of the Association of American Medical Colleges,['10.1097/ACM.0000000000004509']
2612,34753844,Efficacy of Licorice on Salivary  Streptococcus mutans  Levels vs Chlorhexidine Mouthwash in High Caries Risk Patients: A Randomized Clinical Trial.,"AIM


To evaluate the efficacy of an innovative herbal licorice mouthwash on reducing salivary  Streptococcus mutans  levels versus chlorhexidine mouthwash in high caries risk patients.
METHODOLOGY


A total number of 52 high caries risk patients were assigned to this study. Patients were randomly divided into two groups ( n  = 26) according to the type of mouthwash (G): Patients in group G 1  used the mouthwash containing chlorhexidine, while patients in group G 2  used the mouthwash containing the innovative licorice extract. Afterward, each group was further divided into three subgroups according to the time (T): T 0  represents the baseline, T 1  represents the time immediately after using the mouthwash, and T 2  represents the time 1 week after using the mouthwash. Furthermore, pH and plaque index were recorded. Data were statistically analyzed using a Chi-square test for categorical data, Shapiro-Wilk test for numerical data, and one-way repeated measures ANOVA followed by Bonferroni post hoc test for intragroup comparisons. The significance level was set at  p  ≤0.05 for all tests. Statistical analysis was performed with IBM ®  SPSS ®  Statistics version 26 for Windows.
RESULTS


It was found that in high caries risk patients, there was no significant difference between licorice and chlorhexidine mouthwashes regarding  Streptococcus  bacterial count. Moreover, it was found that licorice mouthwash stimulates salivary flow, and thus, it raises salivary pH in patients with high caries risk. However, the plaque index of chlorhexidine showed better results. Additionally, there was a positive weak correlation between bacterial count and plaque index.
CONCLUSIONS


Licorice mouthwash may demonstrate a promising antibacterial effect that can be a suitable alternative for current synthetic mouthwashes.
CLINICAL SIGNIFICANCE


Natural herbal mouthwash could be incorporated in dental preventive measures and could be used as cavity-fighting compound. It introduces a minimal health hazard substitute for conventional synthetic preventive measures.",2021,"It was found that in high caries risk patients, there was no significant difference between licorice and chlorhexidine mouthwashes regarding  Streptococcus  bacterial count.","['52 high caries risk patients', 'high caries risk patients', 'High Caries Risk Patients', 'patients with high caries risk']","['chlorhexidine', 'Chlorhexidine Mouthwash', 'mouthwash containing chlorhexidine, while patients in group G 2  used the mouthwash containing the innovative licorice extract', 'innovative herbal licorice mouthwash', 'Licorice', 'chlorhexidine mouthwash']","['bacterial count and plaque index', 'Furthermore, pH and plaque index']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0352155', 'cui_str': 'Chlorhexidine Mouthwash'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441841', 'cui_str': 'Group G'}, {'cui': 'C2756786', 'cui_str': 'Glycyrrhiza glabra extract'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0017987', 'cui_str': 'Licorice'}]","[{'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",52.0,0.0371922,"It was found that in high caries risk patients, there was no significant difference between licorice and chlorhexidine mouthwashes regarding  Streptococcus  bacterial count.","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Helmy', 'Affiliation': 'Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Cairo, Egypt, Phone: +2001206897557, e-mail: nancy.helmy@dentistry.cu.edu.eg.'}, {'ForeName': 'Shereen', 'Initials': 'S', 'LastName': 'Hafez', 'Affiliation': 'Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Farid', 'Affiliation': 'Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}]",The journal of contemporary dental practice,[]
2613,34753814,Effects of Inhaled Salbutamol on Transient Tachypnea of the Newborn: A Clinical Trial.,"Background:  One of the most common causes of respiratory distress in newborns is transient tachypnea of the newborn (TTN). Salbutamol is often suggested to increase the rate of pulmonary fluid absorption in newborns with TTN. This study hence aimed to evaluate the efficacy of inhaled salbutamol in TTN management. Methods:  This double-blind clinical trial was conducted on 52 newborns admitted to the NICU of Fatemieh Hospital of Hamadan, Iran. The newborns were randomly assigned to two groups of equal members: one group received 2 ml of nebulized sodium chloride (control group) and the other group was treated with 0.1 mg/kg of salbutamol (treatment group). The clinical outcomes were then compared before and 0.5, 1, and 4 hours after the intervention. The data were recorded in a checklist and then were statistically analyzed in SPSS-16: the significant level was decided to be P<0.05. Results:  The comparison of TTN scores revealed a significant difference between the two groups one hour (P=0.005) and four hours (P<0.005) after the intervention. Moreover, the mean fraction of inspired oxygen one hour after the intervention was 53.3±6.6 in the treatment group and 57.7±7.5 in the control group (P=0.022). The mean duration of respiratory support in the treatment and control groups was 2.4±2.7 and 3.1±0.8 days, respectively (P=0.002). The findings suggested no statistically significant difference between the two groups regarding the adverse effects, length of stay (LOS), duration of antibiotics intake, oral feeding resumption time, and maximum oral feeding time (P>0.05). Conclusion:  The study results indicated that inhaled Salbutamol significantly decreased the TTN clinical score, oxygen demands, and duration of respiratory support, whereas there was no significant difference between the groups in terms of LOS.",2021,The comparison of TTN scores revealed a significant difference between the two groups one hour (P=0.005) and four hours (P<0.005) after the intervention.,"['Transient Tachypnea of the Newborn', '52 newborns admitted to the NICU of Fatemieh Hospital of Hamadan, Iran', 'newborns is transient tachypnea of the newborn (TTN', 'newborns with TTN']","['Salbutamol', 'inhaled salbutamol', 'nebulized sodium chloride (control group) and the other group was treated with 0.1 mg/kg of salbutamol', 'inhaled Salbutamol', 'Inhaled Salbutamol']","['TTN scores', 'TTN clinical score, oxygen demands, and duration of respiratory support', 'mean fraction of inspired oxygen one hour', 'rate of pulmonary fluid absorption', 'adverse effects, length of stay (LOS), duration of antibiotics intake, oral feeding resumption time, and maximum oral feeding time (P>0.05', 'mean duration of respiratory support']","[{'cui': 'C0158940', 'cui_str': 'Transitory tachypnea of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0158940', 'cui_str': 'Transitory tachypnea of newborn'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",52.0,0.0823965,The comparison of TTN scores revealed a significant difference between the two groups one hour (P=0.005) and four hours (P<0.005) after the intervention.,[],Respiratory care,['10.4187/respcare.09284']
2614,34754238,Matching-Adjusted Indirect Comparison of Ribociclib Plus Fulvestrant versus Palbociclib Plus Letrozole as First-Line Treatment of HR+/HER2- Advanced Breast Cancer.,"Purpose


Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) plus endocrine therapy are recommended for first-line treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC). However, not all CDK4/6i trials have reported significant overall survival (OS) benefit, and there have been no head-to-head trials. Two trials have reported OS outcomes in first-line patients: MONALEESA-3 reported significant OS benefit with first- or second-line ribociclib plus fulvestrant (RIB+FUL) versus placebo plus fulvestrant (PBO+FUL), while PALOMA-1 reported no significant OS benefit for palbociclib plus letrozole (PAL+LET) versus LET in first-line postmenopausal patients. Matched-adjusted indirect comparisons (MAICs) are an established method for comparing efficacy of treatments from different trials. We used an MAIC to compare first-line patients from MONALEESA-3 and PALOMA-1.
Patients and Methods


An unanchored MAIC of progression-free survival (PFS) and OS in first-line patients with HR+/HER2- ABC treated with RIB+FUL versus PAL+LET was conducted using individual patient data from MONALEESA-3 and aggregated data from PALOMA-1. To match patients in PALOMA-1, patients in MONALEESA-3 were limited to those with no prior endocrine therapy for ABC and no (neo) adjuvant LET ≤12 months before enrollment. PFS and OS were compared using Kaplan-Meier estimators and Cox regression.
Results


A total of 329 and 178 patients from RIB+FUL and PBO+FUL arms, respectively, of MONALEESA-3 were matched to 84 and 81 patients from PAL+LET and LET arms of PALOMA-1. After weighting, OS was significantly longer for RIB+FUL versus PAL+LET (hazard ratio [HR], 0.50; 95% CI, 0.32-0.77;  p  = 0.0020). PFS favored RIB+FUL versus PAL+LET, although the difference was not statistically significant (HR, 0.77; 95% CI, 0.54-1.10;  p  = 0.1553).
Conclusion


Using MAIC to adjust for trial differences, OS comparisons favored RIB+FUL over PAL+LET as first-line treatment in postmenopausal patients with HR+/HER2- ABC. These exploratory results suggest a significant increase in OS benefit with RIB treatment compared with PAL.",2021,"PFS favored RIB+FUL versus PAL+LET, although the difference was not statistically significant (HR, 0.77; 95% CI, 0.54-1.10;  p  = 0.1553).
","['postmenopausal patients with HR+/HER2- ABC', 'To match patients in PALOMA-1, patients in MONALEESA-3 were limited to those with no prior endocrine therapy for ABC and no (neo) adjuvant', 'A total of 329 and 178 patients from RIB+FUL and PBO+FUL arms, respectively, of MONALEESA-3 were matched to 84 and 81 patients from PAL+LET and LET arms of PALOMA-1', 'HR+/HER2- Advanced Breast Cancer']","['placebo plus fulvestrant (PBO+FUL', 'Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) plus endocrine therapy', 'Ribociclib Plus Fulvestrant versus Palbociclib Plus Letrozole', 'RIB+FUL versus PAL+LET', 'letrozole (PAL+LET) versus LET']","['PFS and OS', 'progression-free survival (PFS) and OS', 'OS benefit', 'overall survival (OS) benefit', 'OS outcomes']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",329.0,0.0928603,"PFS favored RIB+FUL versus PAL+LET, although the difference was not statistically significant (HR, 0.77; 95% CI, 0.54-1.10;  p  = 0.1553).
","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Delea', 'Affiliation': 'Policy Analysis Inc. (PAI), Brookline, MA, USA.'}, {'ForeName': 'Yen-Shen', 'Initials': 'YS', 'LastName': 'Lu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'De Boer', 'Affiliation': 'Peter MacCallum Cancer Centre, Victoria, Australia.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'University of California, Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Moynahan', 'Affiliation': 'Policy Analysis Inc. (PAI), Brookline, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chandiwana', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Lanoue', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Huilin', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Thuerigen', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Medical Oncology, Baylor University Medical Center, Texas Oncology and US Oncology Network, Dallas, TX, USA.'}]",Cancer management and research,['10.2147/CMAR.S325043']
2615,34754234,A Comparison of the Clinical Effectiveness Between Low-Dose Strong Opioids and Non-Steroidal Anti-Inflammatory Drugs in the Treatment of Mild Cancer Pain: A Randomized Trial.,"Objective


The present study aims to explore the effectiveness and safety of low-dose strong opioids compared with non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of mild cancer pain.
Methods


From September 2016 to September 2018, 66 patients with a malignant tumor and mild cancer pain admitted to the Department of Oncology of Dalian Fifth People's Hospital were divided into the group A (treated with ibuprofen sustained-release tablets for pain relief) and the group B (treated with oxycodone hydrochloride sustained-release tablets for pain relief). After 7 days of treatment, the pain relief (Numeric Rating Scale [NRS]), physical strength, quality of life scores (Zubrod/ECOG/WHO [ZPS]), the Edmonton Symptom Assessment System [ESAS], and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core15-Palliative [EORTC QLQ-C15-PAL] scores), and the occurrence of adverse reactions between the two groups were compared. The occurrence of adverse reactions in the mid-term (after one month and three months of treatment) between the two groups were also compared.
Results


Both groups had over 90% analgesic efficiency, but complete pain relief was more likely to be obtained in the group B (41.18%). The total analgesic efficiency in the group B was higher (100%) than in the group A (98.9%), and the difference was statistically significant (P < 0.05). The differences in the physical strength and quality of life scores in the two groups before and after treatment were statistically significant (P < 0.05). The differences in the ZPS scores between the two groups were statistically significant (P < 0.05). The differences in ESAS and EORTC QLQ-C15-PAL scores between groups were not statistically significant (P > 0.05).
Conclusion


The application of low-dose oxycodone hydrochloride sustained-release tablets as the initial medication for patients with mild cancer pain was safe and effective, and the adverse reactions were easy to manage.",2021,"The differences in ESAS and EORTC QLQ-C15-PAL scores between groups were not statistically significant (P > 0.05).
","[""Methods\n\n\nFrom September 2016 to September 2018, 66 patients with a malignant tumor and mild cancer pain admitted to the Department of Oncology of Dalian Fifth People's Hospital"", 'mild cancer pain', 'Mild Cancer Pain', 'patients with mild cancer pain']","['Low-Dose Strong Opioids and Non-Steroidal Anti-Inflammatory Drugs', 'low-dose strong opioids compared with non-steroidal anti-inflammatory drugs (NSAIDs', 'ibuprofen sustained-release tablets for pain relief', 'oxycodone hydrochloride', 'oxycodone hydrochloride sustained-release tablets']","['physical strength and quality of life scores', 'effectiveness and safety', 'pain relief (Numeric Rating Scale [NRS]), physical strength, quality of life scores (Zubrod/ECOG/WHO [ZPS]), the Edmonton Symptom Assessment System [ESAS], and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core15-Palliative [EORTC QLQ-C15-PAL] scores), and the occurrence of adverse reactions', 'complete pain relief', 'total analgesic efficiency', 'ZPS scores', 'ESAS and EORTC QLQ-C15-PAL scores', 'analgesic efficiency', 'occurrence of adverse reactions']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C3472649', 'cui_str': 'Edmonton symptom assessment system'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",66.0,0.0252165,"The differences in ESAS and EORTC QLQ-C15-PAL scores between groups were not statistically significant (P > 0.05).
","[{'ForeName': 'Mei-Zuo', 'Initials': 'MZ', 'LastName': 'Liu', 'Affiliation': ""Department of Oncology, The Fifth People's Hospital of Dalian, Dalian, 116000, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Intensive Care Unit, The Fifth People's Hospital of Dalian, Dalian, 116000, People's Republic of China.""}, {'ForeName': 'Jun-Dong', 'Initials': 'JD', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, The Fifth People's Hospital of Dalian, Dalian, 116000, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Oncology, The Fifth People's Hospital of Dalian, Dalian, 116000, People's Republic of China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Oncology, The Fifth People's Hospital of Dalian, Dalian, 116000, People's Republic of China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': ""Department of Oncology, The Fifth People's Hospital of Dalian, Dalian, 116000, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Oncology, The Fifth People's Hospital of Dalian, Dalian, 116000, People's Republic of China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Medical Examination Center, The Fifth People's Hospital of Dalian, Dalian, 116000, People's Republic of China.""}, {'ForeName': 'Ji-Lai', 'Initials': 'JL', 'LastName': 'Bian', 'Affiliation': ""Department of Oncology, The Fifth People's Hospital of Dalian, Dalian, 116000, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S322893']
2616,34754228,Eight Trigrams Boxing Combined with Wenyang Huoxue Recipe Improves Cardiopulmonary Motor Function and the Quality of Life of Patients with Coronary Heart Disease.,"Objective


To investigate the therapeutic effects of Eight Trigrams Boxing combined with a Wenyang Huoxue recipe on the cardiopulmonary motor function and quality of life in patients with coronary heart disease after an interventional operation (percutaneous coronary intervention [PCI]); further, to provide new clinical evidence and ideas for integrated traditional Chinese and Western medicine in cardiac rehabilitation.
Methods


Sixty patients were selected and successfully underwent PCI in designated hospitals after four weeks, from June 2018 to September 2020. The patients were randomly divided into a treatment group and control group, and both groups were given standard pharmaceuticals after PCI and the Wenyang Huoxue recipe. The treatment group was additionally treated with the Eight Trigrams Boxing Method. The control group was provided with aerobic rehabilitation exercise. The maximum oxygen uptake (VO2max), metabolic equivalent (MET), the results of a 6-min walking test, the Seattle Angina Questionnaire (SAQ) score, SF-36 score, and other indicators were evaluated before and after treatment. The therapeutic effect was evaluated by comparison between the groups and within the groups.
Results


The VO2max, MET, 6-min walking distance, SAQ score, and SF-36 score in both groups improved after treatment compared with before treatment. There was no difference between the two groups before treatment. However, after treatment, the VO2max, MET, 6 min walking distance, SAQ score, and SF-36 score in the treatment group were higher compared with the control group.
Conclusion


A traditional Chinese medicine cardiac rehabilitation program of Eight Trigrams Boxing combined with a Wenyang Huoxue recipe can improve the cardiopulmonary function and quality of life of patients. The therapeutic effect was clear and is worthy of further investigation.",2021,"However, after treatment, the VO2max, MET, 6 min walking distance, SAQ score, and SF-36 score in the treatment group were higher compared with the control group.
","['patients with coronary heart disease after an interventional operation (percutaneous coronary intervention [PCI', 'Patients with Coronary Heart Disease', 'Eight Trigrams', 'Methods\n\n\nSixty patients were selected and successfully underwent PCI in designated hospitals after four weeks, from June 2018 to September 2020']","['Boxing combined with a Wenyang Huoxue recipe', 'Eight Trigrams', 'Boxing Combined with Wenyang Huoxue Recipe', 'standard pharmaceuticals after PCI and the Wenyang Huoxue recipe', 'aerobic rehabilitation exercise', 'Wenyang Huoxue recipe']","['maximum oxygen uptake (VO2max), metabolic equivalent (MET), the results of a 6-min walking test, the Seattle Angina Questionnaire (SAQ) score, SF-36 score, and other indicators', 'cardiopulmonary function and quality of life', 'VO2max, MET, 6-min walking distance, SAQ score, and SF-36 score', 'Quality of Life', 'VO2max, MET, 6 min walking distance, SAQ score, and SF-36 score', 'Cardiopulmonary Motor Function', 'therapeutic effect', 'cardiopulmonary motor function and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",60.0,0.0169595,"However, after treatment, the VO2max, MET, 6 min walking distance, SAQ score, and SF-36 score in the treatment group were higher compared with the control group.
","[{'ForeName': 'Xiao-Zhen', 'Initials': 'XZ', 'LastName': 'Hu', 'Affiliation': ""Department of Internal Medicine-Cardiovascular, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ""Department of Internal Medicine-Cardiovascular, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Jia-Hao', 'Initials': 'JH', 'LastName': 'Weng', 'Affiliation': ""Department of Internal Medicine-Cardiovascular, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.""}]",International journal of general medicine,['10.2147/IJGM.S318269']
2617,34754193,Different Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Calcium Balance in Patients with Moderate to Advanced Chronic Kidney Disease.,"Objective


Opposite to lanthanum carbonate (LC), sevelamer hydrochloride (SH) may increase intestinal calcium absorption. The study compared the effects of LC and SH on serum and urine phosphate and calcium, and on hormones regulating mineral-bone metabolism.
Patients and Methods


A prospective randomized crossover study included 34 patients with eGFR <60 mL/min. A single oral dose of LC (1,000 mg) or SH (2,400 mg) was administered in random order 15 minutes after a standardized meal fortified with 5 g calcium carbonate. Serum calcium, phosphate, and parathormone were measured before and 3, 6, 12, and 24 hours after each medication. Bone alkaline phosphatase (BAP), sclerostin, calcitriol, and FGF-23 were measured at baseline and after 12 and 24 hours. A 24-hour calcium and phosphate excretion was measured after each drug.
Results


Serum calcium increased 3 and 6 hours after SH then returned to baseline. After LC calcium was unchanged for up to 3 hours then transiently increased and eventually returned to baseline. The area under curve (AUC) of serum calcium for 12 hours after SH was larger than after LC ( p =0.04). Serum phosphate decreased after each drug with a nadir 3 hours post-SH and 6 hours post-LC. AUC of serum phosphate was similar after both medications. PTH decreased transiently after both drugs. BAP did not change. FGF-23 was constant for the first 12 hours but later decreased after each drug.
Conclusion


A 2,400 mg SH and 1,000 mg LC are similarly effective in lowering serum phosphate in CKD, but LC induce in less intestinal calcium absorption after a meal. The trial was registered on February 23, 2018 in the clinicaltrial.gov database - NCT03451019.",2021,"Bone alkaline phosphatase (BAP), sclerostin, calcitriol, and FGF-23 were measured at baseline and after 12 and 24 hours.","['34 patients with eGFR <60 mL/min', 'Patients with Moderate to Advanced Chronic Kidney Disease']","['Lanthanum Carbonate and Sevelamer Hydrochloride', 'SH', 'LC and SH', 'lanthanum carbonate (LC), sevelamer hydrochloride (SH', 'LC']","['Calcium Balance', 'Bone alkaline phosphatase (BAP), sclerostin, calcitriol, and FGF-23', 'AUC of serum phosphate', 'Serum calcium', 'intestinal calcium absorption', 'Serum phosphate', 'PTH', 'FGF-23', 'Serum calcium, phosphate, and parathormone', '24-hour calcium and phosphate excretion', 'area under curve (AUC) of serum calcium', 'BAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0772463', 'cui_str': 'Sevelamer hydrochloride'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C1431973', 'cui_str': 'FGF23 protein, human'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",34.0,0.014949,"Bone alkaline phosphatase (BAP), sclerostin, calcitriol, and FGF-23 were measured at baseline and after 12 and 24 hours.","[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Makowka', 'Affiliation': 'Department of Nephrology, Hypertension and Kidney Transplantation, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Nowicki', 'Affiliation': 'Department of Nephrology, Hypertension and Kidney Transplantation, Medical University of Lodz, Lodz, Poland.'}]",Therapeutics and clinical risk management,['10.2147/TCRM.S330649']
2618,34754408,CT Image Features under Reconstruction Algorithm in Analysis of the Effect of Probiotics Combined with Ursodeoxycholic Acid in Treatment of Intrahepatic Cholestasis of Pregnancy.,"This research was to explore the adoption value of computed tomography (CT) images based on adaptive statistical iterative reconstruction (ASIR) algorithm in the evaluation of probiotics combined with ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy (ICP). A total of 82 patients with ICP were selected as the research subjects and they were randomly rolled into experimental group (380 mg probiotics enteric-soluble capsule twice a day, combined with 90 mg ursodeoxycholic acid soft capsule three times a day) and control group (90 mg ursodeoxycholic acid soft capsule three times a day), with 41 cases in each. The treatment course was four months. The ASIR algorithm was constructed and applied to the CT image analysis and diagnosis of ICP patients. The effects of filtering back projection (FBP) reconstruction and ASIR algorithm on CT image quality, denoising degree, and artifacts of ICP patients were compared. Moreover, blood indicator levels of ICP patients before and after treatment were assessed. The results showed that the SD values of liver and gallbladder (20.77 Hu and 27.58 Hu) in the reconstructed image of the ASIR algorithm were significantly lower than those of the FBP algorithm (40.58 Hu and 45.63 Hu) ( P  < 0.05). The SNR values of the liver and gallbladder (3.68 and 2.05) of the reconstructed image were significantly higher than those of the FBP algorithm (1.91 and 1.19) ( P  < 0.05). The overall image quality after ASIR reconstruction (3.92 points) was significantly better than that of the FBP algorithm (2.36 points), and the image noise score (3.21 points) reconstructed by the FBP algorithm was higher than that by the ASIR algorithm (1.83 points). The artifact score of FBP reconstructed image (4.47 points) was greatly higher than that of ASIR algorithm (2.26 points) ( P  < 0.05). Before treatment, there was no remarkable difference in the indexes between the two groups of patients ( P  > 0.05). After treatment, the  γ -glutamyltransferase ( γ -GT) and alkaline phosphatase (ALP) levels (327.55 U/L and 778.15  μ mol/L) of the experimental group of ICP patients were higher than those of the control group (248.63 U/L and 668.43  μ mol/L), with substantial difference between the two groups ( P  < 0.05). The blood ammonia (BA) level (151.09  μ mol/L) of the experimental group was lower than that of the control group (178.46  μ mol/L), and the difference between the two groups was remarkable ( P  < 0.05). To sum up, the CT image denoising degree based on ASIR algorithm was high, with few artifacts and good overall quality. Probiotics combined with ursodeoxycholic acid in the treatment of ICP can effectively improve the liver function and intestinal flora of patients, which was of great significance in the clinical diagnosis and treatment of the disease.",2021,"The overall image quality after ASIR reconstruction (3.92 points) was significantly better than that of the FBP algorithm (2.36 points), and the image noise score (3.21 points) reconstructed by the FBP algorithm was higher than that by the ASIR algorithm (1.83 points).","['82 patients with ICP were selected as the research subjects', 'intrahepatic cholestasis of pregnancy (ICP']","['computed tomography (CT) images based on adaptive statistical iterative reconstruction (ASIR) algorithm', 'Probiotics', 'filtering back projection (FBP) reconstruction and ASIR algorithm', 'Ursodeoxycholic Acid', 'ursodeoxycholic acid', 'probiotics enteric-soluble capsule twice a day, combined with 90\u2009mg ursodeoxycholic acid soft capsule three times a day) and control group (90\u2009mg ursodeoxycholic acid']","['liver function and intestinal flora', 'Intrahepatic Cholestasis of Pregnancy', 'image noise score', 'SNR values of the liver and gallbladder', 'γ -glutamyltransferase ( γ -GT) and alkaline phosphatase (ALP) levels', 'overall image quality after ASIR reconstruction', 'blood indicator levels', 'blood ammonia (BA) level', 'SD values of liver and gallbladder']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0268318', 'cui_str': 'Cholestasis of pregnancy'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1273639', 'cui_str': 'Soft capsule'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0268318', 'cui_str': 'Cholestasis of pregnancy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0428332', 'cui_str': 'Alkaline phosphatase level - finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428437', 'cui_str': 'Blood ammonia measurement'}]",82.0,0.052855,"The overall image quality after ASIR reconstruction (3.92 points) was significantly better than that of the FBP algorithm (2.36 points), and the image noise score (3.21 points) reconstructed by the FBP algorithm was higher than that by the ASIR algorithm (1.83 points).","[{'ForeName': 'Hongxue', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics, The Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University, Huai'an 223300, Jiangsu, China.""}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics, The Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University, Huai'an 223300, Jiangsu, China.""}, {'ForeName': 'Muling', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Obstetrics, The Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University, Huai'an 223300, Jiangsu, China.""}]",Journal of healthcare engineering,['10.1155/2021/1709793']
2619,34754402,Patent hemostasis of radial artery: Comparison of two methods.,"BACKGROUND


Radial artery obstruction is the most common complication of coronary angiography performed  via  transradial access. Patent hemostasis can significantly reduce the risk of radial artery occlusion. Previous studies utilized sophisticated methods to evaluate radial artery patency. Simplified and easily applicable methods for successful patent hemostasis are currently lacking.
AIM


To determine which method (pulse oximeter  vs  the traditional radial artery palpation) is better to achieve patent hemostasis.
METHODS


This prospective, single center study included 299 consecutive patients who underwent coronary angiography or percutaneous coronary intervention between November 2017 and July 2019. Patients less than 18 years old, with a history of radial artery disease, or no palpable artery pulse were excluded from the study. Patients were randomly assigned to two groups. In the first group, radial artery flow was assessed by palpation of the artery during hemostasis (traditional method). In the second group, radial artery patency was estimated with the use of a pulse oximeter. Two different compression devices were used for hemostasis (air chamber and pressure valve). The primary study endpoint was the achievement of successful patent hemostasis.
RESULTS


The two groups (pulse oximeter  vs  artery palpation) had no significant differences in age, sex, body mass index, risk factors, or comorbidities except for supraventricular arrhythmias. The percentage of patients with successful patent hemostasis was significantly higher in the pulse oximeter group (82.2%  vs  68.1%,  P  = 0.005). A lower percentage of patients with spasm was recorded in the pulse oximeter group (9.9%  vs  19.0%,  P  = 0.024). The incidence of local complications, edema, bleeding, hematoma, vagotonia, or pain did not differ between the two groups. In the multivariate analysis, the use of a pulse oximeter (OR: 2.35, 95%CI: 1.34-4.13,  P  = 0.003) and advanced age (OR: 1.04, 95%CI: 1.01-1.07,  P  = 0.006), were independently associated with an increased probability of successful patent hemostasis. The type of hemostatic device did not affect patent hemostasis ( P  = 0.450).
CONCLUSION


Patent hemostasis with the use of pulse oximeter is a simple, efficient, and safe method that is worthy of further investigation. Larger randomized studies are required to consider its clinical implications.",2021,"The incidence of local complications, edema, bleeding, hematoma, vagotonia, or pain did not differ between the two groups.","['299 consecutive patients who underwent', 'Patients less than 18 years old, with a history of radial artery disease, or no palpable artery pulse were excluded from the study', 'between November 2017 and July 2019']","['method (pulse oximeter  vs  the traditional radial artery palpation', 'pulse oximeter', 'coronary angiography or percutaneous coronary intervention']","['risk of radial artery occlusion', 'percentage of patients with successful patent hemostasis', 'age, sex, body mass index, risk factors, or comorbidities except for supraventricular arrhythmias', 'incidence of local complications, edema, bleeding, hematoma, vagotonia, or pain', 'patent hemostasis', 'achievement of successful patent hemostasis', 'radial artery patency', 'probability of successful patent hemostasis', 'radial artery flow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0522499', 'cui_str': 'Palpable'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0428974', 'cui_str': 'Supraventricular arrhythmia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C1455782', 'cui_str': 'Vagotonia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",299.0,0.0352512,"The incidence of local complications, edema, bleeding, hematoma, vagotonia, or pain did not differ between the two groups.","[{'ForeName': 'Vassileios', 'Initials': 'V', 'LastName': 'Kyriakopoulos', 'Affiliation': 'Department of Cardiology, Konstantopoulio General Hospital, Athens 14233, Greece.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Xanthopoulos', 'Affiliation': 'Department of Cardiology, University Hospital of Larissa, Larissa 41110, Greece. andrewvxanth@gmail.com.'}, {'ForeName': 'Michail', 'Initials': 'M', 'LastName': 'Papamichalis', 'Affiliation': 'Department of Cardiology, University Hospital of Larissa, Larissa 41110, Greece.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Skoularigkis', 'Affiliation': 'Department of Cardiology, University Hospital of Larissa, Larissa 41110, Greece.'}, {'ForeName': 'Chara', 'Initials': 'C', 'LastName': 'Tzavara', 'Affiliation': 'Department of Health, Medical School, University of Athens, Athens 11527, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Papadakis', 'Affiliation': 'Department of Cardiology, Konstantopoulio General Hospital, Athens 14233, Greece.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Patsilinakos', 'Affiliation': 'Department of Cardiology, Konstantopoulio General Hospital, Athens 14233, Greece.'}, {'ForeName': 'Filippos', 'Initials': 'F', 'LastName': 'Triposkiadis', 'Affiliation': 'Department of Cardiology, University Hospital of Larissa, Larissa 41110, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Skoularigis', 'Affiliation': 'Department of Cardiology, University Hospital of Larissa, Larissa 41110, Greece.'}]",World journal of cardiology,['10.4330/wjc.v13.i10.574']
2620,34754346,Transversus Abdominis Plane (TAP) Block: A Comparative Study between Levobupivacaine versus Levobupivacaine plus Ketamine in Abdominoplasty.,"Purpose


We conducted this study to explore the hypothesis that the addition of ketamine to levobupivacaine in ultrasound-guided Transversus Abdominis Plane (TAP) block would result in a better and prolonged duration of postoperative analgesia for patients undergoing abdominoplasty.  Material and Methods . This randomized prospective study was conducted on 50 patients who were scheduled for abdominoplasty. TAP block was performed bilaterally for all patients either with levobupivacaine 0.5% 15 ml plus ketamine 0.5 mg/kg in a total volume of 20 ml in the LK group ( n  = 25) or with levobupivacaine 0.5% 15 ml plus 5 ml normal saline in a total volume of 20 ml in the L group on each side.
Results


Visual analogue scale (VAS) was significantly lower in the LK group in resting condition at 6, 12, and 16 h postoperatively compared to the L group. On movement, the VAS was significantly lower at 4, 6, 8, 12, 16, and 24 h postoperatively in the LK group compared to the L group. The time for first rescue analgesia was longer in the LK group (18.7 ± 4.8 h) than that in the L group (6.5 ± 2.4 h) with the reduced total amount of rescue morphine in the LK group (1.14 ± 2.2 mg) versus the L group (5.86 ± 3.6 mg). Only six patients in the LK group requested rescue morphine, whereas nineteen patients requested rescue morphine in the L group.
Conclusions


In TAP block, adding ketamine 0.5 mg/kg enhanced the analgesic efficacy of levobupivacaine 0.5% in patients undergoing abdominoplasty and reduced the required analgesics postoperatively.",2021,"In TAP block, adding ketamine 0.5 mg/kg enhanced the analgesic efficacy of levobupivacaine 0.5% in patients undergoing abdominoplasty and reduced the required analgesics postoperatively.","['Abdominoplasty', 'patients undergoing abdominoplasty', '50 patients who were scheduled for abdominoplasty']","['levobupivacaine 0.5% 15\u2009ml plus ketamine', 'levobupivacaine', 'Levobupivacaine plus Ketamine', 'ketamine to levobupivacaine', 'LK', 'ketamine', 'Levobupivacaine', 'levobupivacaine 0.5% 15\u2009ml plus 5\u2009ml normal saline', 'Transversus Abdominis Plane (TAP) Block', 'morphine']","['time for first rescue analgesia', 'total amount of rescue morphine', 'Visual analogue scale (VAS', 'VAS', 'analgesic efficacy']","[{'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.0603525,"In TAP block, adding ketamine 0.5 mg/kg enhanced the analgesic efficacy of levobupivacaine 0.5% in patients undergoing abdominoplasty and reduced the required analgesics postoperatively.","[{'ForeName': 'Radwa F', 'Initials': 'RF', 'LastName': 'Mansour', 'Affiliation': 'Lecturer of Anesthesia and Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Afifi', 'Affiliation': 'Lecturer of Anesthesia and ICU, Alazhar Faculty of Medicine in Cairo, Alazhar University, Cairo, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Abdelghany', 'Affiliation': 'Lecturer of Anesthesia and Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Pain research & management,['10.1155/2021/1762853']
2621,34754329,Effects of Plyometric Exercises versus Flatfoot Corrective Exercises on Postural Control and Foot Posture in Obese Children with a Flexible Flatfoot.,"Background


Obesity contributes to the acquired flatfoot deformity which in turn impairs balance.
Aim


The purpose of the current study was to compare the effect of plyometric exercises with flatfoot corrective exercises on balance, foot posture, and functional mobility in obese children with a flexible flatfoot.
Methods


Forty-seven children participated in the study. Their age ranged from 7 to 11 years. Participants were randomly divided into 3 groups: experimental group I (EGI), experimental group II (EGII), and the control group (CG). The EGI received plyometric exercises and the EGII received corrective exercises, 2 sessions weekly for 10 weeks. The control group did not perform any planned physical activities. The Prokin system was used to assess balance, the timed up and go test (TUG) was used to assess functional mobility, and the navicular drop test (NDT) was used to assess foot posture.
Results


EGI showed significant improvement in all balance parameters, foot posture, and TUG. EGII showed improvement in the ellipse area and perimeter in addition to foot posture and TUG.
Conclusion


Plyometric exercises and foot correction exercises had a positive effect on foot posture, balance, and functional mobility in obese children with flatfeet.",2021,"Results


EGI showed significant improvement in all balance parameters, foot posture, and TUG.","['Obese Children with a Flexible Flatfoot', 'Methods\n\n\nForty-seven children participated in the study', 'obese children with a flexible flatfoot', 'obese children with flatfeet']","['Plyometric Exercises versus Flatfoot Corrective Exercises', 'Plyometric exercises and foot correction exercises', 'plyometric exercises with flatfoot corrective exercises']","['ellipse area and perimeter in addition to foot posture and TUG', 'Postural Control and Foot Posture', 'balance, foot posture, and functional mobility', 'balance parameters, foot posture, and TUG', 'foot posture, balance, and functional mobility']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0152237', 'cui_str': 'Flexible Flatfoot'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0016202', 'cui_str': 'Flatfeet'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0016202', 'cui_str': 'Flatfeet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",47.0,0.0172293,"Results


EGI showed significant improvement in all balance parameters, foot posture, and TUG.","[{'ForeName': 'Hatem H', 'Initials': 'HH', 'LastName': 'Allam', 'Affiliation': 'Department of Physical Therapy, College of Applied Medical Sciences, Taif University, Saudi Arabia.'}, {'ForeName': 'Alsufiany', 'Initials': 'A', 'LastName': 'Muhsen', 'Affiliation': 'Department of Physical Therapy, College of Applied Medical Sciences, Taif University, Saudi Arabia.'}, {'ForeName': 'Mosfer A', 'Initials': 'MA', 'LastName': 'Al-Walah', 'Affiliation': 'Department of Physical Therapy, College of Applied Medical Sciences, Taif University, Saudi Arabia.'}, {'ForeName': 'Abdulmajeed N', 'Initials': 'AN', 'LastName': 'Alotaibi', 'Affiliation': 'Children Hospital, Taif Health Affairs, Ministry of Health, Saudi Arabia.'}, {'ForeName': 'Shayek S', 'Initials': 'SS', 'LastName': 'Alotaibi', 'Affiliation': 'Department of Medical Rehabilitation and Physiotherapy, Children Hospital, Ministry of Health, Taif, Saudi Arabia.'}, {'ForeName': 'Lamiaa K', 'Initials': 'LK', 'LastName': 'Elsayyad', 'Affiliation': 'Department of Biomechanics, Faculty of Physical Therapy, Cairo University, Egypt.'}]",Applied bionics and biomechanics,['10.1155/2021/3635660']
2622,34754306,Attention Bias to Pain Words Comes Early and Cognitive Load Matters: Evidence from an ERP Study on Experimental Pain.,"Attention bias (AB) is a common cognitive challenge for patients with pain. In this study, we tested at what stage AB to pain occurs in participants with experimental pain (EP) and tested whether cognitive load interferes with it. We recruited 40 healthy adults aged 18-27 years, and randomized them into control and EP groups. We sprayed the participants in the EP group with 10% capsaicin paste to mimic acute pain and those in the control group with water, accessing both groups' behavioral results and event-related potential data. We found that high-load tasks had longer response times and lower accuracies than low-load tasks did and that different neural processing of words occurred between the groups. The EP group exhibited AB to pain at an early stage with both attentional avoidance (N1 latency) and facilitated attention (P2 amplitude) to pain words. The control group coped with semantic differentiation (N1) at first, followed by pain word discrimination (P2). In addition, AB to pain occurred only in low-load tasks. As the cognitive load multiplied, we did not find AB in the EP group. Therefore, our study adds further evidence for AB to pain, suggesting the implementation of cognitive load in future AB therapy.",2021,The EP group exhibited AB to pain at an early stage with both attentional avoidance (N1 latency) and facilitated attention (P2 amplitude) to pain words.,"['participants with experimental pain (EP', '40 healthy adults aged 18-27 years', 'patients with pain']",['capsaicin paste'],['AB to pain'],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.104828,The EP group exhibited AB to pain at an early stage with both attentional avoidance (N1 latency) and facilitated attention (P2 amplitude) to pain words.,"[{'ForeName': 'Kangling', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Howe', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Physical Therapy, Health Science Center, University of North Texas, Fort Worth, TX, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}]",Neural plasticity,['10.1155/2021/9940889']
2623,34755014,Institutional variation in survival and morbidity in laparoscopic surgery for colon cancer: From the data of a randomized controlled trial comparing open and laparoscopic surgery (JCOG0404).,"Background


Institutional variation in outcomes is a key factor to ascertain the generalizability of results and reliability of the clinical trial. This study evaluated institutional variation in survival and postoperative complications using data from JCOG0404 comparing laparoscopic colectomy (LAP) with open colectomy (OP).
Methods


Institutions with fewer than 10 registered patients were excluded from this analysis. Institutional variation was evaluated in terms of early postoperative complications, overall survival, and relapse-free survival and estimated using a mixed-effect model with institution as a random effect after adjusting for background factors.
Results


This analysis included 1028 patients in the safety analysis and 1040 patients in the efficacy analysis from 26 institutions. In the safety analysis, there was no variation in grades 3-4 early postoperative complications (in OP, median 6.3% [range 6.3%-6.3%]; in LAP, median 2.6% [range 2.6%-2.6%]), but some variation in grades 1-4 early postoperative complications was observed (in OP, median 20.8% [range 13.2%-31.8%]; in LAP, median 11.9% [range 7.2%-28.7%]), and that in grades 2-4 was observed only in LAP (median 8.8% [range 4.7%-24.0%]; in OP, median 12.7% [range 12.7%-12.7%]). Two specific institutions showed especially high incidences of postoperative complications in LAP. In the efficacy analysis, there was no institutional variation in OP, although a certain variation was observed in LAP.
Conclusions


Some institutional variations in safety and efficacy were observed, although only in LAP. We conclude that a qualification system, including training and education, is needed when new surgical techniques such as laparoscopic surgery are introduced in clinical practice.",2021,"Some institutional variations in safety and efficacy were observed, although only in LAP.","['1028 patients in the safety analysis and 1040 patients in the efficacy analysis from 26 institutions', 'Methods\n\n\nInstitutions with fewer than 10 registered patients were excluded from this analysis', 'colon cancer']","['laparoscopic surgery (JCOG0404', 'laparoscopic colectomy (LAP) with open colectomy (OP', 'laparoscopic surgery']","['postoperative complications', 'safety and efficacy', 'early postoperative complications, overall survival, and relapse-free survival', 'survival and morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}, {'cui': 'C0149750', 'cui_str': 'Partial resection of colon'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.165147,"Some institutional variations in safety and efficacy were observed, although only in LAP.","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office National Cancer Center Hospital Tokyo Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Inomata', 'Affiliation': 'Department of Gastroenterological and Pediatric Surgery Oita University Faculty of Medicine Oita Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office National Cancer Center Hospital Tokyo Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office National Cancer Center Hospital Tokyo Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Surgery Kitasato University Kitasato Institute Hospital Tokyo Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Akagi', 'Affiliation': 'Department of Gastroenterological and Pediatric Surgery Oita University Faculty of Medicine Oita Japan.'}, {'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterological Surgery Tokai University School of Medicine Kanagawa Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Department of Colorectal Surgery National Cancer Center Hospital East Chiba Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kinugasa', 'Affiliation': 'Department of Gastrointestinal Surgery Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Masazumi', 'Initials': 'M', 'LastName': 'Okajima', 'Affiliation': 'Department of Surgery Hiroshima City Hiroshima Citizens Hospital Hiroshima Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Takemasa', 'Affiliation': 'Department of Surgery Surgical Oncology and Science Sapporo Medical University Hokkaido Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Okuda', 'Affiliation': 'General and Gastroenterological Surgery Osaka Medical College Osaka Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Shida', 'Affiliation': 'Department of Colorectal Surgery National Cancer Center Hospital Tokyo Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'Department of Colorectal Surgery National Cancer Center Hospital Tokyo Japan.'}, {'ForeName': 'Seigo', 'Initials': 'S', 'LastName': 'Kitano', 'Affiliation': 'Oita University Oita Japan.'}]",Annals of gastroenterological surgery,['10.1002/ags3.12484']
2624,34755012,Identification of patient subgroups with unfavorable long-term outcomes associated with laparoscopic surgery in a randomized controlled trial comparing open and laparoscopic surgery for colon cancer (Japan Clinical Oncology Group Study JCOG0404).,"Background


Previously, we conducted a randomized controlled trial (JCOG0404) for stage II/III colon cancer patients and reported that the long-term survival after open surgery (OP) and laparoscopic surgery (LAP) were almost identical; however, JCOG0404 suggested that survival of patients after LAP with tumors located in the rectosigmoid colon, cT4 or cN2 tumors, and high body mass index (BMI) might be unfavorable.
Aim


To identify the patient subgroups associated with poor long-term survival in the LAP arm compared with the OP arm.
Methods


Patients aged 20-75, clinical T3 or deeper lesion without involvement of other organs, clinical N0-2 and M0 were included. The patients with pathological stage IV and R2 resection were excluded from the current analysis. In each subgroup, the hazard ratio for LAP (vs. OP) in overall survival (OS) from surgery was estimated using a multivariable Cox regression model adjusted for the clinical and pathological factors.
Results


In total, 1025 patients (OP, 511 and LAP, 514) were included in the current analysis. Adjusted hazards ratios for OS of patients with high BMI (>25 kg/m 2 ), pT4, and pN2 in LAP were 3.37 (95% confidence interval [CI], 1.24-9.19), 1.33 (0.73-2.41), and 1.74 (0.76-3.97), respectively. In contrast, that of rectosigmoid colon tumors was 0.98 (0.46-2.09).
Conclusions


Although LAP is an acceptable optional treatment for stage II/III colon cancer, the present subgroup analysis suggests that high BMI (>25 kg/m 2 ), pT4, and pN2 except for RS were factors associated with unfavorable long-term outcomes of LAP in patients with colon cancer who underwent curative resection. (JCOG 0404: NCT00147134/UMIN-CTR: C000000105.).",2021,"In each subgroup, the hazard ratio for LAP (vs. OP) in overall survival (OS) from surgery was estimated using a multivariable Cox regression model adjusted for the clinical and pathological factors.
","['1025 patients (OP, 511 and LAP, 514) were included in the current analysis', 'patients with pathological stage IV and R2 resection', 'stage II/III colon cancer patients', 'patients with colon cancer who underwent curative resection', 'Methods\n\n\nPatients aged 20-75, clinical T3 or deeper lesion without involvement of other organs, clinical N0-2 and M0 were included']","['open surgery (OP) and laparoscopic surgery (LAP', 'laparoscopic surgery', 'LAP']","['hazard ratio for LAP', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1025.0,0.458636,"In each subgroup, the hazard ratio for LAP (vs. OP) in overall survival (OS) from surgery was estimated using a multivariable Cox regression model adjusted for the clinical and pathological factors.
","[{'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Division of Surgery Gastrointestinal Center Yokohama Shin-Midori General Hospital Yokohama Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Akagi', 'Affiliation': 'Department of Gastroenterological and Pediatric Surgery Oita University Faculty of Medicine Oita Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office National Cancer Center Hospital Tokyo Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Wakabayashi', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office National Cancer Center Hospital Tokyo Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Inomata', 'Affiliation': 'Department of Gastroenterological and Pediatric Surgery Oita University Faculty of Medicine Oita Japan.'}, {'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Surgery Tokai University School of Medicine Kanagawa Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Department of Colorectal Surgery National Cancer Center Hospital East Chiba Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kinugasa', 'Affiliation': 'Department of Gastrointestinal Surgery Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Egi', 'Affiliation': 'Department of Gastrointestinal Surgery and Surgical Oncology Ehime University Graduate School of Medicine Ehime Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Munakata', 'Affiliation': 'Department of Surgery Nagano Municipal Hospital Nagano Japan.'}, {'ForeName': 'Yukihito', 'Initials': 'Y', 'LastName': 'Kokuba', 'Affiliation': 'Department of Gastroenterological Surgery St. Marianna University Yokohama Seibu Hospital Yokohama Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Department of Gastroenterological Surgery Ishikawa Prefectural Central Hospital Kanazawa Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Yasui', 'Affiliation': 'Department of Gastroenterological Surgery Osaka International Cancer Institute Osaka Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Division of Lower Gastrointestinal Surgery, Department of Gastroenterological Surgery Hyogo College of Medicine Nishinomiya Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Nakajima', 'Affiliation': 'Department of Surgery NTT Medical Center Tokyo Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Shida', 'Affiliation': 'Division of Frontier Surgery The Institute of Medical Science The University of Tokyo Tokyo Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'Department of Colorectal Surgery National Cancer Center Hospital Tokyo Japan.'}, {'ForeName': 'Seigo', 'Initials': 'S', 'LastName': 'Kitano', 'Affiliation': 'Oita University Oita Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of gastroenterological surgery,['10.1002/ags3.12475']
2625,34755007,Utility of monthly minodronate for osteoporosis after gastrectomy: Prospective multicenter randomized controlled trials.,"Aim


Osteoporosis in patients after gastrectomy is increasing with the aging of gastric cancer patients. Bisphosphonates are effective treatments for osteoporosis; however, their safety or efficacy in postgastrectomy patients has not been established. The purpose of this multicenter prospective intervention study was to investigate the impact of monthly minodronate on osteoporosis after gastrectomy.
Methods


Of the 261 enrolled gastric cancer patients, 164 patients were diagnosed with osteoporosis based on criteria of the Japan Society of Osteoporosis. They were randomly assigned 1:1 to groups treated with active vitamin D (VD group) or monthly minodronate (MIN group). The primary endpoint was changes in lumbar bone mineral density (L-BMD) 12 mo after the start of administration. The secondary endpoints were changes in bone metabolism markers, adverse events (AEs), or treatment completion rates.
Results


There was no significant difference in patient background between the VD (n = 82) and MIN (n = 82) groups. In the MIN group, the increase in L-BMD was significantly higher than that in the VD group (4.52% vs 1.72%,  P  = .001), with a significant reduction in bone metabolism markers; blood NTX (-25.6% vs -1.6%,  P  < .01) and serum bone-specific alkaline phosphatase (-34.3% vs -20.1%,  P  < .01). AEs were observed in 26.8% and 9.3% of the patients and treatment completion rates were 77.5% and 89.3% in the MIN and VD groups, respectively. Serious AEs were not observed in either group.
Conclusion


This study demonstrated the safety and efficacy of monthly minodronate, suggesting that this treatment may be useful for osteoporosis after gastrectomy (UMIN000015517).",2021,There was no significant difference in patient background between the VD (n = 82) and MIN (n = 82) groups.,"['patients after gastrectomy', 'osteoporosis after gastrectomy', '261 enrolled gastric cancer patients, 164 patients were diagnosed with osteoporosis based on criteria of the Japan Society of Osteoporosis', 'gastric cancer patients']","['active vitamin D (VD group) or monthly minodronate (MIN group', 'Bisphosphonates']","['lumbar bone mineral density (L-BMD', 'serum bone-specific alkaline phosphatase', 'treatment completion rates', 'L-BMD', 'safety and efficacy', 'bone metabolism markers, adverse events (AEs), or treatment completion rates', 'bone metabolism markers; blood NTX']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0662880', 'cui_str': 'minodronate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}]",261.0,0.0775963,There was no significant difference in patient background between the VD (n = 82) and MIN (n = 82) groups.,"[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Hirota', 'Affiliation': 'Department of Surgery Toyonaka municipal hospital Osaka Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Gastroenterological Surgery Osaka University Graduate School of Medicine Osaka Japan.'}, {'ForeName': 'Yurina', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterological Surgery Osaka University Graduate School of Medicine Osaka Japan.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Kawabata', 'Affiliation': 'Department of Surgery Osaka Rosai Hospital Sakai Japan.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Nakatsuka', 'Affiliation': 'Department of Surgery Osaka General medical center Osaka Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Imamura', 'Affiliation': 'Department of Surgery Toyonaka municipal hospital Osaka Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Motoori', 'Affiliation': 'Department of Surgery Osaka General medical center Osaka Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Makari', 'Affiliation': 'Department of Surgery Sakai city medical center Sakai Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeno', 'Affiliation': 'Department of Surgery Kansai Rosai Hospital Amagasaki Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kishi', 'Affiliation': 'Department of Surgery Osaka police hospital Osaka Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Adachi', 'Affiliation': 'Department of Surgery Ikeda municipal hospital Ikeda Japan.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Miyagaki', 'Affiliation': 'Department of Surgery Saiseikai Senri Hospital Suita Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Department of Gastroenterological Surgery Osaka University Graduate School of Medicine Osaka Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Gastroenterological Surgery Osaka University Graduate School of Medicine Osaka Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': 'Department of Gastroenterological Surgery Osaka University Graduate School of Medicine Osaka Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Gastroenterological Surgery Osaka University Graduate School of Medicine Osaka Japan.'}]",Annals of gastroenterological surgery,['10.1002/ags3.12474']
2626,34754981,Comparing pregabalin and gabapentin for persistent neuropathic pain: A protocol for a pilot N-of-1 trial series.,"Background


Evidence-based management of neuropathic pain is commonly ineffective due to the large variability in response between cases. Patients often have to trial several drugs before finding one that provides adequate relief, leading to increased costs and worsened outcomes. There is thus a need for tools to guide and streamline prescribing decisions in neuropathic pain. N-of-1 trials provide a potentially precise and economical method of selecting between multiple interventions in an individual patient, and merit a feasibility assessment for use in clinical pain practice.
Aims


We aim to evaluate the feasibility of N-of-1 trials to compare pregabalin and gabapentin for individual presentations of neuropathic pain.
Methods


This is a double-blinded multiple crossover study, with recruitment from existing patients at an outpatient pain clinic in New South Wales, Australia. Participants will undergo three 4-week treatment pairs, comprising 2 weeks of pregabalin (150-600 mg/day) and 2 weeks of gabapentin (900-3600 mg/day), in an individually randomised order. Intervention doses will be derived from participants' existing treatment dose. Medications will be taken orally three times daily. The primary outcome will be pain intensity; measures will be self-reported daily in patient diaries. After completing all three cycles, participants and their physicians will be presented with the results of the trial to form an informed decision about their treatment.
Discussion


As a stable yet debilitating condition, neuropathic pain is especially amenable to an N-of-1 study design. A successful trial would represent a significant quality of life improvement for the patient, possibly extending over the course of their lifetime.",2021,"A successful trial would represent a significant quality of life improvement for the patient, possibly extending over the course of their lifetime.","['persistent neuropathic pain', 'patients at an outpatient pain clinic in New South Wales, Australia']","['pregabalin and gabapentin', 'pregabalin', 'gabapentin']","['quality of life improvement', 'pain intensity; measures will be self-reported daily in patient diaries']","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",,0.174231,"A successful trial would represent a significant quality of life improvement for the patient, possibly extending over the course of their lifetime.","[{'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Bashford', 'Affiliation': 'Department of Rehabilitation Medicine, Port Kembla Hospital, Wollongong, Australia.'}, {'ForeName': 'Samuel X', 'Initials': 'SX', 'LastName': 'Tan', 'Affiliation': 'Centre for Clinical Research, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McGree', 'Affiliation': 'School of Mathematical Sciences, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Murdoch', 'Affiliation': 'Wollongong Hospital, Wollongong, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Nikles', 'Affiliation': 'Centre for Clinical Research, University of Queensland, Brisbane, Australia.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2021.100852']
2627,34754954,Quality assurance of dysphagia-optimised intensity modulated radiotherapy treatment planning for head and neck cancer.,"This study aimed to assess the impact of the margin applied to the clinical target volume, to create the planning target volume, on plan quality of a novel dysphagia-optimised intensity modulated radiotherapy technique developed within a head and neck cancer multicentre randomised controlled trial. Protocol compliant plans were used for a single benchmark planning case. Larger margins were associated with higher doses to adjacent organs at risk, particularly the inferior pharyngeal constrictor muscle, but coincided with some improved low dose target coverage. A 3 mm margin is recommended for this technique if local practices allow.",2021,"Larger margins were associated with higher doses to adjacent organs at risk, particularly the inferior pharyngeal constrictor muscle, but coincided with some improved low dose target coverage.",['head and neck cancer'],"['dysphagia-optimised intensity modulated radiotherapy treatment planning', 'novel dysphagia-optimised intensity modulated radiotherapy technique']",[],"[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],,0.052095,"Larger margins were associated with higher doses to adjacent organs at risk, particularly the inferior pharyngeal constrictor muscle, but coincided with some improved low dose target coverage.","[{'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Tyler', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, The Royal Marsden NHS Foundation Trust, 203 Fulham Road, London SW3 6JJ, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bernstein', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, The Royal Marsden NHS Foundation Trust, 203 Fulham Road, London SW3 6JJ, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Seithel', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, The Royal Marsden NHS Foundation Trust, 203 Fulham Road, London SW3 6JJ, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Rooney', 'Affiliation': 'Radiotherapy Department, The Royal Marsden NHS Foundation Trust, 203 Fulham Road, London SW3 6JJ, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Petkar', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miles', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, Middlesex HA6 2RN, UK.'}, {'ForeName': 'Catharine H', 'Initials': 'CH', 'LastName': 'Clark', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, Middlesex HA6 2RN, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Nutting', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, UK.'}]",Physics and imaging in radiation oncology,['10.1016/j.phro.2021.10.003']
2628,34754899,Therapeutic responsiveness to vagus nerve stimulation in patients receiving beta-blockade for heart failure with reduced ejection fraction.,"Background


The effect of beta-blockade (BB) on response to vagus nerve stimulation (VNS) has not been reported in patients with heart failure and reduced ejection fraction (HFrEF). In the ANTHEM-HF Study, 60 patients received chronic cervical VNS. Background pharmacological therapy remained unchanged during the study, and VNS intensity was stable once up-titrated. Significant improvement from baseline occurred in resting 24-hour heart rate (HR), 24-hour HR variability (SDNN), left ventricular EF (LVEF), 6-minute walk distance (6MWD), and quality of life (MLWHFS) at 6 months post-titration. We evaluated whether response to VNS was related to percentage of target BB dose (PTBBD) at baseline.
Methods


Patients were categorized by baseline PTBBD, then analyzed for changes from baseline in symptoms and function at 6 months after VNS titration.
Results


All patients received BB, either PTBBD ≥ 50 % (16 patients, 27 %; group 1) or PTBBD < 50 % (44 patients, 73 %; group 2). Heart rate, systolic blood pressure, LVEF, use of ACE/ARB, and use of MRA were similar between the two groups at baseline. Six months after up-titration, VNS reduced HR and significantly improved SDNN, LVEF, 6MWD, and MLWHFS equally in both groups.
Conclusions


In the ANTHEM-HF study, VNS responsiveness appeared to be independent of the baseline BB dose administered.",2021,"Six months after up-titration, VNS reduced HR and significantly improved SDNN, LVEF, 6MWD, and MLWHFS equally in both groups.
","['patients with heart failure and reduced ejection fraction (HFrEF', 'patients receiving beta-blockade for heart failure with reduced ejection fraction', '60 patients received chronic cervical VNS']",['beta-blockade (BB'],"['SDNN, LVEF, 6MWD, and MLWHFS', 'Heart rate, systolic blood pressure, LVEF, use of ACE/ARB, and use of MRA', 'resting 24-hour heart rate (HR), 24-hour HR variability (SDNN), left ventricular EF (LVEF), 6-minute walk distance (6MWD), and quality of life (MLWHFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0615479,"Six months after up-titration, VNS reduced HR and significantly improved SDNN, LVEF, 6MWD, and MLWHFS equally in both groups.
","[{'ForeName': 'Enea', 'Initials': 'E', 'LastName': 'Dede', 'Affiliation': 'Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Gregory', 'Affiliation': 'Clinical Cardiovascular Science Foundation, Boston, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Ardell', 'Affiliation': 'University of California at Los Angeles, Los Angeles, USA.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Libbus', 'Affiliation': 'LivaNova USA, Inc., Houston, USA.'}, {'ForeName': 'Lorenzo A', 'Initials': 'LA', 'LastName': 'DiCarlo', 'Affiliation': 'LivaNova USA, Inc., Houston, USA.'}, {'ForeName': 'Rajendra K', 'Initials': 'RK', 'LastName': 'Premchand', 'Affiliation': 'Krishna Institute of Medical Sciences, Secunderabad, India.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Sanjivani Super Specialty Hospitals, Ahmedabad, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Medanta, The Medicity, Haryana, India.'}, {'ForeName': 'Rufino', 'Initials': 'R', 'LastName': 'Monteiro', 'Affiliation': 'Vintage Hospital, Goa, India.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'Hans-Dirk', 'Initials': 'HD', 'LastName': 'Düngen', 'Affiliation': 'Charité Universitätsmedizin Berlin, Germany.'}]",International journal of cardiology. Heart & vasculature,['10.1016/j.ijcha.2021.100888']
2629,34754850,Effect of family caregiver nursing education on patients with rheumatoid arthritis and its impact factors: A randomized controlled trial.,"BACKGROUND


Rheumatoid arthritis (RA) is a common autoimmune disease. Nursing education for family caregivers is considered a workable and effective intervention, but the validity of this intervention in RA has not been reported.
AIM


To explore whether family caregiver nursing education (FCNE) works on patients with RA and the factors that influence FCNE.
METHODS


In this randomized controlled study, a sample of 158 pairs was included in the study with 80 in the intervention group and 78 in the control group. Baseline data of patients and caregivers was collected. The FCNE intervention was administered to caregivers, and inflammation level indicators, disease activity indicators and mood disorder indicators of patients were followed up and analyzed.
RESULTS


Baseline characteristics of the intervention and the control groups had no significant difference. Indicators were significantly reduced in the intervention group compared to the control group. The intervention group showed significant differences in stratification of relationship, education duration and age.
CONCLUSION


The effect of FCNE on RA is multifaceted, weakening inflammation level, alleviating disease activity and relieving mood disorder. Relationship between caregiver and patient, caregiver's education level and patient's age may act as impact factors of FCNE.",2021,Indicators were significantly reduced in the intervention group compared to the control group.,"['patients with RA and the factors that influence FCNE', 'patients with rheumatoid arthritis and its impact factors', 'a sample of 158 pairs was included in the study with 80 in the intervention group and 78 in the control group']","['family caregiver nursing education (FCNE', 'family caregiver nursing education', 'FCNE']","['stratification of relationship, education duration and age', 'inflammation level indicators, disease activity indicators and mood disorder indicators']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0013636', 'cui_str': 'Nursing Education'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}]",158.0,0.16787,Indicators were significantly reduced in the intervention group compared to the control group.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Immunology and Rheumatology, The Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China. jinglijingli0311@163.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Immunology and Rheumatology, The Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China.'}, {'ForeName': 'Ya-Juan', 'Initials': 'YJ', 'LastName': 'Kang', 'Affiliation': 'Department of Immunology and Rheumatology, The Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Ma', 'Affiliation': 'Department of Immunology and Rheumatology, The Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China.'}]",World journal of clinical cases,['10.12998/wjcc.v9.i28.8413']
2630,34754845,Short-term effect and long-term prognosis of neuroendoscopic minimally invasive surgery for hypertensive intracerebral hemorrhage.,"BACKGROUND


Hypertensive intracerebral hemorrhage is a common critical disease of the nervous system, comprising one fifth of all acute cerebrovascular diseases and has a high disability and mortality rate. It severely affects the patients' quality of life.
AIM


To analyze the short-term effect and long-term prognosis of neuroendoscopic minimally invasive surgery for hypertensive intracerebral hemorrhage.
METHODS


From March 2018 to May 2020, 118 patients with hypertensive intracerebral hemorrhage were enrolled in our study and divided into a control group and observation group according to the surgical plan. The control group used a hard-channel minimally invasive puncture and drainage procedure. The observation group underwent minimally invasive neuroendoscopic surgery. The changes in the levels of serum P substances (SP), inflammatory factors [tumor necrosis factor-α, interleukin-6 (IL-6), IL-10], and the National Hospital Stroke Scale (NIHSS) and Barthel index scores were recorded. Surgery related indicators and prognosis were compared between the two groups.
RESULTS


The operation time (105.26 ± 28.35) of the observation group was min longer than that of the control group, and the volume of intraoperative bleeding was 45.36 ± 10.17 mL more than that of the control group. The hematoma clearance rates were 88.58% ± 4.69% and 94.47% ± 4.02% higher than those of the control group at 48 h and 72 h, respectively. Good prognosis rate (86.44%) was higher in the observation group than in the control group, and complication rate (5.08%) was not significantly different from that of the control group ( P  > 0.05).The SP level and Barthel index score of the two groups increased ( P  < 0.05) and the inflammatory factors and NIHSS score decreased ( P  < 0.05). The cytokine levels, NIHSS score, and Barthel index score were better in the observation group than in the control group ( P  < 0.05).
CONCLUSION


Neuroendoscopic minimally invasive surgery is more complicated than hard channel minimally invasive puncture drainage in the treatment of hypertensive intracerebral hemorrhage; however, hematoma clearance is more thorough, and the short-term effect and long-term prognosis are better than hard channel minimally invasive puncture drainage.",2021,"The cytokine levels, NIHSS score, and Barthel index score were better in the observation group than in the control group ( P  < 0.05).
","['From March 2018 to May 2020, 118 patients with hypertensive intracerebral hemorrhage', 'hypertensive intracerebral hemorrhage']","['Neuroendoscopic minimally invasive surgery', 'minimally invasive neuroendoscopic surgery', 'neuroendoscopic minimally invasive surgery', 'control group and observation group according to the surgical plan', 'hard-channel minimally invasive puncture and drainage procedure']","['SP level and Barthel index score', 'hematoma clearance rates', 'volume of intraoperative bleeding', 'cytokine levels, NIHSS score, and Barthel index score', 'operation time', 'complication rate', 'inflammatory factors and NIHSS score', 'Good prognosis rate', 'levels of serum P substances (SP), inflammatory factors [tumor necrosis factor-α, interleukin-6 (IL-6), IL-10], and the National Hospital Stroke Scale (NIHSS) and Barthel index scores']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751892', 'cui_str': 'Hypertensive Hemorrhage, Cerebral'}]","[{'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",118.0,0.0543774,"The cytokine levels, NIHSS score, and Barthel index score were better in the observation group than in the control group ( P  < 0.05).
","[{'ForeName': 'Jian-Hui', 'Initials': 'JH', 'LastName': 'Wei', 'Affiliation': 'Department of Neurosurgery, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China.'}, {'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Tian', 'Affiliation': 'Department of Neurology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China.'}, {'ForeName': 'Ya-Zhao', 'Initials': 'YZ', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China.'}, {'ForeName': 'Xue-Jing', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China.'}, {'ForeName': 'Jian-Hui', 'Initials': 'JH', 'LastName': 'Mao', 'Affiliation': 'Department of Neurology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China. weijianhui2005@126.com.'}]",World journal of clinical cases,['10.12998/wjcc.v9.i28.8358']
2631,34754834,Short-term effectiveness of high- and low-intensity percutaneous electrolysis in patients with patellofemoral pain syndrome: A pilot study.,"BACKGROUND


Unilateral patellofemoral pain syndrome (PFPS) is the most frequently diagnosed knee condition in populations aged < 50 years old. Although the treatment of myofascial trigger points (MTrPs) is a common and effective tool for reducing pain, previous studies showed no additional benefits compared with placebo in populations with PFPS. Percutaneous electrolysis is a minimally invasive approach frequently used in musculotendinous pathologies which consists of the application of a galvanic current through dry needling (DN).
AIM


To evaluate changes in sensitivity, knee pain perception and perceived pain during the application of these three invasive techniques.
METHODS


A triple-blinded, pilot randomized controlled trial was conducted on fifteen patients with unilateral PFPS who were randomized to the high-intensity percutaneous electrolysis (HIPE) experimental group, low-intensity percutaneous electrolysis (LIPE) experimental group or DN active control group. All interventions were conducted in the most active MTrP, in the rectus femoris muscle. The HIPE group received a 660 mA galvanic current for 10 s, the LIPE group 220 mA × 30 s and the DN group received no galvanic current. The MTrP and patellar tendon pain pressure thresholds (PPTs) and subjective anterior knee pain perception (SAKPP) were assessed before, after and 7 d after the single intervention. In addition, perceived pain during the intervention was also assessed.
RESULTS


Both groups were comparable at baseline as no significant differences were found for age, height, weight, body mass index, PPTs or SAKPP. No adverse events were reported during or after the interventions. A significant decrease in SAKPP (both HIPE and LIPE,  P  < 0.01) and increased patellar tendon PPT (all,  P  < 0.001) were found, with no differences between the groups (VAS: F = 0.30; η 2  = 0.05;  P  > 0.05; tendon PPT immediate effects: F = 0.15; η 2  = 0.02;  P  > 0.05 and tendon PPT 7-d effects: F = 0.67; η 2  = 0.10;  P  > 0.05). A significant PPT increase in rectus femoris MTrP was found at follow-up in both the HIPE and LIPE groups (both,  P  < 0.001) with no differences between the groups (immediate effects: F= 1.55; η 2  = 0.20;  P  > 0.05 and 7-d effects: F = 0.71; η 2  = 0.10;  P  > 0.05). Both HIPE and LIPE interventions were considered less painful compared with DN (F = 8.52; η 2  = 0.587;  P  < 0.01).
CONCLUSION


HIPE and LIPE induce PPT changes in MTrPs and patellar tendon and improvements in SAKPP, and seem to produce less pain during the intervention compared with DN.",2021,"A significant decrease in SAKPP (both HIPE and LIPE,  P  < 0.01) and increased patellar tendon PPT (all,  P  < 0.001) were found, with no differences between the groups (VAS: F = 0.30; η 2  = 0.05;  P  > 0.05; tendon PPT immediate effects: F = 0.15; η 2  = 0.02;  P  > 0.05 and tendon PPT 7-d effects: F = 0.67; η 2  = 0.10;  P  > 0.05).","['fifteen patients with unilateral PFPS', 'Unilateral patellofemoral pain syndrome (PFPS', 'patients with patellofemoral pain syndrome', 'populations aged < 50 years old']","['high-intensity percutaneous electrolysis (HIPE) experimental group, low-intensity percutaneous electrolysis (LIPE) experimental group or DN active control group', '660 mA galvanic current for 10 s, the LIPE group 220 mA × 30 s and the DN group received no galvanic current', 'high- and low-intensity percutaneous electrolysis', 'placebo', 'Percutaneous electrolysis']","['SAKPP', 'PPT increase in rectus femoris MTrP', 'pain', 'adverse events', 'patellar tendon PPT', 'sensitivity, knee pain perception and perceived pain', 'MTrP and patellar tendon pain pressure thresholds (PPTs) and subjective anterior knee pain perception (SAKPP', 'age, height, weight, body mass index, PPTs or SAKPP', 'perceived pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0240671', 'cui_str': 'Partial thromboplastin time increased'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",15.0,0.0463457,"A significant decrease in SAKPP (both HIPE and LIPE,  P  < 0.01) and increased patellar tendon PPT (all,  P  < 0.001) were found, with no differences between the groups (VAS: F = 0.30; η 2  = 0.05;  P  > 0.05; tendon PPT immediate effects: F = 0.15; η 2  = 0.02;  P  > 0.05 and tendon PPT 7-d effects: F = 0.67; η 2  = 0.10;  P  > 0.05).","[{'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Valera-Calero', 'Affiliation': 'Department of Physiotherapy, Camilo Jose Cela University, Madrid 28692, Spain. javalera@ucjc.edu.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sánchez-Mayoral-Martín', 'Affiliation': 'Department of Physiotherapy, Camilo Jose Cela University, Madrid 28692, Spain.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Varol', 'Affiliation': 'Business Analytics and Big Data, IE School of Human Sciences and Technology, Madrid 28006, Spain.'}]",World journal of orthopedics,['10.5312/wjo.v12.i10.781']
2632,34755269,Colchicine Is Safe Though Ineffective in the Treatment of Severe COVID-19: a Randomized Clinical Trial (COLCHIVID).,"BACKGROUND


Colchicine is an available, safe, and effective anti-inflammatory drug and has been suggested as a COVID-19 treatment, but its usefulness in hospitalized severe COVID-19 patients has not been thoroughly demonstrated.
OBJECTIVE


To address the safety and efficacy of colchicine in hospitalized patients with severe COVID-19.
DESIGN


We conducted a triple-blind parallel non-stratified placebo-controlled clinical trial.
PARTICIPANTS


We recruited 116 hospitalized patients with severe COVID-19 in Mexico.
INTERVENTIONS


Patients were randomized to receive 1.5 mg of colchicine or placebo at the time of the recruitment in the study (baseline) and 0.5 mg BID PO to complete 10 days of treatment.
MAIN MEASURES


The primary composite outcome was the progression to critical disease or death. Besides, we evaluated immunological features at baseline and after recovery or disease progression in 20 patients.
KEY RESULTS


Fifty-six patients were allocated to colchicine and 60 patients received placebo. The study was suspended after the second interim analysis demonstrated colchicine had no effect on the primary outcome (OR 0.83, 95%CI 0.35-1.93, P = 0.67), nor in the days of ICU and hospital stays. Adverse events were similar between groups (OR 1.63, 95% CI 0.66-3.88, P = 0.37). After colchicine treatment, patients had higher BUN and lower serum levels of IL-8, IL-12p70, and IL-17A.
CONCLUSIONS


Colchicine is safe but not effective in the treatment of severe COVID-19.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04367168.",2021,"After colchicine treatment, patients had higher BUN and lower serum levels of IL-8, IL-12p70, and IL-17A.
CONCLUSIONS


Colchicine is safe but not effective in the treatment of severe COVID-19.
","['116 hospitalized patients with severe COVID-19 in Mexico', 'hospitalized patients with severe COVID-19', '20 patients', 'hospitalized severe COVID-19 patients', 'Fifty-six patients']","['colchicine', 'Colchicine', 'placebo', 'colchicine or placebo']","['safety and efficacy', 'Adverse events', 'progression to critical disease or death']","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",116.0,0.594064,"After colchicine treatment, patients had higher BUN and lower serum levels of IL-8, IL-12p70, and IL-17A.
CONCLUSIONS


Colchicine is safe but not effective in the treatment of severe COVID-19.
","[{'ForeName': 'Abdiel', 'Initials': 'A', 'LastName': 'Absalón-Aguilar', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Rull-Gabayet', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Pérez-Fragoso', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Mejía-Domínguez', 'Affiliation': 'Bioinformatics, Biostatistics and Computational Biology Unit, Red de apoyo a la investigación Coordinación de Investigación Científica, Universidad Nacional Autónoma de México, Mexico City, Mexico.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Núñez-Álvarez', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kershenobich-Stalnikowitz', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Sifuentes-Osornio', 'Affiliation': 'Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Ponce-de-León', 'Affiliation': 'Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'González-Lara', 'Affiliation': 'Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Martín-Nares', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Montesinos-Ramírez', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Ramírez-Alemón', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ramírez-Rangel', 'Affiliation': 'Department of Cardiology, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.'}, {'ForeName': 'Manlio F', 'Initials': 'MF', 'LastName': 'Márquez', 'Affiliation': 'Department of Clinical Investigation, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Plata-Corona', 'Affiliation': 'Department of Cardiology, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Juárez-Vega', 'Affiliation': 'Flow Cytometry Unit, Red de Apoyo a La Investigacion, Coordinacion de Investigacion Cientifica, Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Gómez-Martín', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Jiram', 'Initials': 'J', 'LastName': 'Torres-Ruiz', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico. josetorresruiz85@gmail.com.'}]",Journal of general internal medicine,['10.1007/s11606-021-07203-8']
2633,34755519,Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER.,"Background Thromboprophylaxis extended after hospital discharge in medically ill patients currently is not recommended by practice guidelines because of uncertainty about the benefit for preventing major or fatal thromboembolic events, and the risk of bleeding. Methods and Results We assessed the benefit and risk of thromboprophylaxis with rivaroxaban 10 mg once daily extended for 25 to 45 days after hospitalization for preventing major thromboembolism in medically ill patients using the pooled data in 16 496 patients from 2 randomized trials, MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) and MAGELLAN (Multicenter, randomized, parallel-group efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically ill patients comparing rivaroxaban with enoxaparin). The data from the MARINER trial were pooled with the data from the MAGELLAN trial in patients who were free of thrombotic or bleeding events up to the last dose of enoxaparin/placebo and who continued in the outpatient phase of thromboprophylaxis. The composite outcome of major thromboembolic events (symptomatic deep vein thrombosis, nonfatal pulmonary embolism, myocardial infarction, and nonhemorrhagic stroke) and all-cause mortality was used to assess benefit and was compared with the risk of the composite of fatal and critical site bleeding. The incidence of the composite efficacy outcome was 1.80% (148 of 8222 patients) in the rivaroxaban group, compared with 2.31% (191 of 8274 patients in the placebo group) (HR, 0.78 [95% CI, 0.63-0.97],  P =0.024). Fatal or critical site bleeding events were infrequent and occurred in <0.1% of patients in both groups (rivaroxaban 0.09%; placebo 0.04%; HR, 2.36;  P =0.214). Conclusions The results suggest a benefit for reducing major thromboembolic outcomes (number needed to treat: 197), with a favorable trade-off to fatal or critical site bleeding (number needed to harm: 2045). Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00571649 and NCT02111564.",2021,"Fatal or critical site bleeding events were infrequent and occurred in <0.1% of patients in both groups (rivaroxaban 0.09%; placebo 0.04%; HR, 2.36;  P =0.214).","['hospitalized medically ill patients comparing', 'medically ill patients using the pooled data in 16\xa0496 patients from 2 randomized trials, MARINER (Medically Ill Patient Assessment of', 'medically ill patients']","['rivaroxaban with enoxaparin', 'Rivaroxaban', 'rivaroxaban', 'enoxaparin/placebo', 'Rivaroxaban Versus Placebo']","['Fatal or critical site bleeding events', 'major thromboembolic events (symptomatic deep vein thrombosis, nonfatal pulmonary embolism, myocardial infarction, and nonhemorrhagic stroke) and all-cause mortality', 'incidence of the composite efficacy outcome', 'thrombotic or bleeding events', 'major thromboembolic outcomes', 'risk of the composite of fatal and critical site bleeding']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3805136', 'cui_str': 'Nonhaemorrhagic stroke'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",16496.0,0.460059,"Fatal or critical site bleeding events were infrequent and occurred in <0.1% of patients in both groups (rivaroxaban 0.09%; placebo 0.04%; HR, 2.36;  P =0.214).","[{'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Raskob', 'Affiliation': 'Hudson College of Public HealthUniversity of Oklahoma Health Sciences Center Oklahoma City OK.'}, {'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Spyropoulos', 'Affiliation': 'Department of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill HospitalThe Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, The Feinstein Institute for Medical Research New York NY.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Thrombosis and Hematology Therapeutic Area Clinical Development Pharmaceuticals Bayer U.S. LLC Whippany NJ.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Janssen Research and Development LLC Raritan NJ.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Janssen Research and Development LLC Titusville NJ.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Levitan', 'Affiliation': 'Janssen Research and Development LLC Titusville NJ.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Suh', 'Affiliation': 'Janssen Research and Development LLC Raritan NJ.'}, {'ForeName': 'Elliot S', 'Initials': 'ES', 'LastName': 'Barnathan', 'Affiliation': 'Janssen Research and Development LLC Raritan NJ.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.021579']
2634,34755426,Outpatient diuretic intensification as endpoint in HFpEF trials: an analysis from TOPCAT.,"BACKGROUND


Outpatient treatment for the worsening of signs and symptoms of heart failure (HF) is usually not incorporated in the main outcomes of HF trials. Patients with heart failure with a preserved ejection fraction (HFpEF) may experience frequent episodes of outpatient worsening.
OBJECTIVES


To study the frequency, prognostic impact, and the effect of spironolactone on outpatient diuretic intensification (ODI), among 1767 patients enrolled in TOPCAT-Americas.
METHODS


Time-updated Cox models and win ratio analysis. ODI was defined by a post-randomization loop diuretic dose increase or new initiation. The median follow-up was 2.9 years.
RESULTS


At baseline, 1362 (77%) patients were taking loop diuretics. During the follow-up, 685 (38.8%) patients experienced ODI, which was associated with a higher risk of subsequent cardiovascular events and death: adjusted HR (95%CI) for HF hospitalization or cardiovascular death=1.67 (1.36-2.04), HR (95%CI) for cardiovascular death=2.17 (1.64-2.87), and HR (95%CI) for all-cause mortality=1.75 (1.41-2.16) (p<0.001 for all outcomes). Adding ODI to the composite of HF hospitalization or cardiovascular death increased the event-rate by 3-fold in the placebo group (from 10.4 to 29.9 events per 100 person-years). Spironolactone treatment led to a 26% relative reduction of the extended composite of ODI or HF hospitalization or cardiovascular death: HR (95%CI) 0.74 (0.65-0.85), p-value<0.001 compared with a 16% relative reduction of HF hospitalization or cardiovascular death: HR (95%CI) 0.84 (0.70-0.99), p-value=0.044. Using win ratio provided similar estimates.
CONCLUSION


In HFpEF, ODI was frequent and independently associated with subsequent cardiovascular events. Spironolactone significantly reduced an extended composite outcome incorporating ODI. This article is protected by copyright. All rights reserved.",2021,"Spironolactone treatment led to a 26% relative reduction of the extended composite of ODI or HF hospitalization or cardiovascular death: HR (95%CI) 0.74 (0.65-0.85), p-value<0.001 compared with a 16% relative reduction of HF hospitalization or cardiovascular death: HR (95%CI) 0.84 (0.70-0.99), p-value=0.044.","['Patients with heart failure with a preserved ejection fraction (HFpEF', '1767 patients enrolled in TOPCAT-Americas']","['placebo', 'Spironolactone', 'spironolactone']","['HF hospitalization or cardiovascular death: HR', 'ODI', 'extended composite of ODI or HF hospitalization or cardiovascular death', 'higher risk of subsequent cardiovascular events and death: adjusted HR (95%CI) for HF hospitalization or cardiovascular', 'extended composite outcome incorporating ODI', 'HF hospitalization or cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0002454', 'cui_str': 'America'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1767.0,0.386273,"Spironolactone treatment led to a 26% relative reduction of the extended composite of ODI or HF hospitalization or cardiovascular death: HR (95%CI) 0.74 (0.65-0.85), p-value<0.001 compared with a 16% relative reduction of HF hospitalization or cardiovascular death: HR (95%CI) 0.84 (0.70-0.99), p-value=0.044.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations Cliniques Plurithématique 1433, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'Jiankang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Vardeny', 'Affiliation': 'Minneapolis VA Center for Care Delivery and Outcomes Research, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Division of Cardiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations Cliniques Plurithématique 1433, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}]",European journal of heart failure,['10.1002/ejhf.2376']
2635,34755413,Comparing objective wakefulness and vigilance tests to on-the-road driving performance in narcolepsy and idiopathic hypersomnia.,"Patients with narcolepsy or idiopathic hypersomnia (IH) are at increased risk of driving accidents. Both excessive daytime sleepiness, i.e. unwanted sleep episodes during the day, and disturbed vigilance are core features of these disorders. We tested on-the-road driving performance of patients with narcolepsy or IH coming in for a routine driving fitness evaluation and examined: (1) correlations between driving performance and the Maintenance of Wakefulness Test (MWT), Sustained Attention to Response Task (SART) and Psychomotor Vigilance Test (PVT) as objective tests; (2) the predictive power of the MWT and SART for increased risk of impaired driving; (3) the best set of objective predictors for increased risk of impaired driving. Participants were 44 patients (aged 18-75 years) with narcolepsy type 1 (NT1), type 2 (NT2) or IH. They completed the MWT, SART, PVT, a subjective sleepiness questionnaire, and a standardised on-the-road driving test. The standard deviation of the lateral position (SDLP) was used as outcome measure of driving performance. The MWT had low correlation with the SDLP (ρ = -0.41 to -0.49, p < 0.01). The SART and PVT had low correlations with SDLP (ρ = 0.30 and ρ = 0.39, respectively, both p < 0.05). The predictive power of MWT for an increased risk of impaired driving was significant, but low (area under the curve = 0.273, p = 0.012), and non-significant for SART. We conclude that in our present group, none of the tests had adequate ability to predict impaired driving, questioning their use for clinical driving fitness evaluation in narcolepsy and IH. Real-time monitoring of sleepiness while driving seems more promising in these patients.",2021,"The predictive power of MWT for an increased risk of impaired driving was significant, but low (area under the curve = 0.273, p = 0.012), and non-significant for SART.","['Patients with narcolepsy or idiopathic hypersomnia (IH', 'narcolepsy and idiopathic hypersomnia', 'Participants were 44 patients (aged 18-75\xa0years) with narcolepsy type 1 (NT1), type 2 (NT2) or IH', 'patients with narcolepsy or IH coming in for a routine driving fitness evaluation and examined']",[],"['risk of impaired driving', 'Maintenance of Wakefulness Test (MWT), Sustained Attention to Response Task (SART) and Psychomotor Vigilance Test (PVT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0033138', 'cui_str': 'Primary hypersomnia'}, {'cui': 'C0911524', 'cui_str': 'AM 44'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4543926', 'cui_str': 'Narcolepsy type 1'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}]",44.0,0.0586267,"The predictive power of MWT for an increased risk of impaired driving was significant, but low (area under the curve = 0.273, p = 0.012), and non-significant for SART.","[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bijlenga', 'Affiliation': 'Sleep-Wake Centre, Stichting Epilepsie Instellingen Nederland (SEIN), Heemstede, the Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Urbanus', 'Affiliation': 'Sleep-Wake Centre, Stichting Epilepsie Instellingen Nederland (SEIN), Heemstede, the Netherlands.'}, {'ForeName': 'Nick N J J M', 'Initials': 'NNJJM', 'LastName': 'van der Sluiszen', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Overeem', 'Affiliation': 'Centre for Sleep Medicine, Kempenhaeghe, Heeze, the Netherlands.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Vermeeren', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Gert Jan', 'Initials': 'GJ', 'LastName': 'Lammers', 'Affiliation': 'Sleep-Wake Centre, Stichting Epilepsie Instellingen Nederland (SEIN), Heemstede, the Netherlands.'}]",Journal of sleep research,['10.1111/jsr.13518']
2636,34755389,The acute effects of milk intake on calcium homeostasis and cardiovascular outcome: A randomized crossover trial in postmenopausal women.,"OBJECTIVE


The importance of calcium intake from dairy in regard to cardiovascular health has been investigated in several studies with discrepant results. Hence, we aim to investigate the immediate effects of milk intake on cardiovascular function.
DESIGN


A randomized crossover study with at least 10 days for washout between the two interventions, 500 ml of water with 200 µg of cholecalciferol or 500 ml of semi-skimmed milk containing approximately 600 mg of calcium with 200 µg of cholecalciferol.
PATIENTS


Twenty community-based postmenopausal women aged 60-80 years.
MEASUREMENTS


Parathyroid hormone and ionized calcium were measured at baseline and after 2 and 4 h on each study day. Pulse wave analysis and velocity were measured at baseline and after 4 h on each study day.
RESULTS


Compared to water, milk intake increased ionized calcium levels by 0.02 mmol/L (p = .029) and decreased parathyroid hormone levels by 1.78 pmol/L (p < .001). The two interventions caused no changes as measured 4 h after the intervention in the following indices of cardiovascular health; pulse wave velocity, brachial diastolic or systolic blood pressure, central diastolic or systolic blood pressure, mean arterial pressure, pulse pressure, augmentation pressure, augmentation index, heart rate or pulse transit time.
CONCLUSIONS


Despite significant changes in calcium homeostasis with increased levels of ionized calcium following milk intake, no acute effects seem to occur on measures of cardiovascular health.",2021,"Compared to water, milk intake increased ionized calcium levels by 0.02 mmol/L (p = .029) and decreased parathyroid hormone levels by 1.78 pmol/L (p < .001).","['postmenopausal women', 'Twenty community-based postmenopausal women aged 60-80 years']","['cholecalciferol or 500\u2009ml of semi-skimmed milk containing approximately 600\u2009mg of calcium with 200\u2009µg of cholecalciferol', 'milk intake']","['ionized calcium levels', 'cardiovascular health; pulse wave velocity, brachial diastolic or systolic blood pressure, central diastolic or systolic blood pressure, mean arterial pressure, pulse pressure, augmentation pressure, augmentation index, heart rate or pulse transit time', 'parathyroid hormone levels', 'Parathyroid hormone and ionized calcium', 'cardiovascular health', 'calcium homeostasis and cardiovascular outcome']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0452714', 'cui_str': 'Semi-skimmed milk'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556180', 'cui_str': 'Milk intake'}]","[{'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C3494432', 'cui_str': 'Pulse Transit Time'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C3653518', 'cui_str': 'CALCIUM HOMEOSTASIS'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0979064,"Compared to water, milk intake increased ionized calcium levels by 0.02 mmol/L (p = .029) and decreased parathyroid hormone levels by 1.78 pmol/L (p < .001).","[{'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Espersen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rejnmark', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",Clinical endocrinology,['10.1111/cen.14632']
2637,34755312,Adapted ERAS Pathway Versus Standard Care in Patients Undergoing Emergency Surgery for Perforation Peritonitis-a Randomized Controlled Trial.,"BACKGROUND


Enhanced Recovery After Surgery (ERAS) pathways have an uncertain role in emergencies. To the best of our knowledge, there are no trials studying ERAS in perforation peritonitis across the GI tract, despite it being a common surgical emergency.
AIMS


To evaluate the safety, feasibility and efficacy of adapted ERAS protocols in emergency laparotomy for perforation peritonitis.
METHODS


This was an open-labeled, superiority randomized controlled trial conducted between October 2018 and June 2020 in patients with perforation peritonitis assigned to standard care or adapted ERAS groups using block randomization. Patients with refractory shock, ASA class 4E, localized peritonitis, etc. were excluded. Components of the adapted ERAS protocol included epidural analgesia, goal-directed fluid therapy, avoidance of opioids, early mobilization, early removal of tubes, drains and catheters, and early enteral feeding. The primary outcome, length of hospitalization (LOH), and the secondary outcomes, functional recovery parameters, were analyzed between both the groups.
RESULTS


A total of 59 patients in standard care group and 61 patients in adapted ERAS group were included and randomized, and were comparable in terms of demographic and clinico-pathological characteristics. LOH in adapted ERAS group was shorter by 3 days (p < 0.001), and patients showed reduction in time (days) to first flatus (2.84 vs 4.22, p < 0.001), first stool (4.38 vs 6.08, p < 0.001) and solid diet (4.67 vs 8.37, p < 0.001). Post-operative nausea, vomiting (p = 0.05) and surgical site infections (p < 0.001) were reduced in adapted ERAS group. Pre-existing malignancy, respiratory complications and high output stoma were reasons for delayed discharge in adapted ERAS group.
CONCLUSION


Adapted ERAS pathways considerably reduce LOH in patients undergoing emergency surgery for perforation peritonitis, with no adverse events in 30 days after discharge.
TRIAL REGISTRATION


Registered at http://ctri.nic.in/Clinicaltrials/login.php (CTRI/2019/02/017537).",2021,"Post-operative nausea, vomiting (p = 0.05) and surgical site infections (p < 0.001) were reduced in adapted ERAS group.","['patients undergoing emergency surgery for perforation peritonitis', '59 patients in standard care group and 61 patients in adapted ERAS group', 'Patients with refractory shock, ASA class 4E, localized peritonitis, etc. were excluded', 'Patients Undergoing Emergency Surgery for Perforation Peritonitis', 'October 2018 and June 2020 in patients with perforation peritonitis assigned to standard care or adapted ERAS groups using block randomization']","['adapted ERAS protocols', 'Adapted ERAS Pathway Versus Standard Care']","['reduction in time (days) to first flatus', 'Post-operative nausea, vomiting', 'surgical site infections', 'LOH', 'epidural analgesia, goal-directed fluid therapy, avoidance of opioids, early mobilization, early removal of tubes, drains and catheters, and early enteral feeding', 'length of hospitalization (LOH), and the secondary outcomes, functional recovery parameters', 'safety, feasibility and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0349412', 'cui_str': 'Refractory shock'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.277194,"Post-operative nausea, vomiting (p = 0.05) and surgical site infections (p < 0.001) were reduced in adapted ERAS group.","[{'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Pranavi', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Sathasivam', 'Initials': 'S', 'LastName': 'Sureshkumar', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Thulasingam', 'Initials': 'T', 'LastName': 'Mahalakshmy', 'Affiliation': 'Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kundra', 'Affiliation': 'Department of Anesthesia and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India. drvikramkate@gmail.com.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-021-05184-x']
2638,34755287,"Efficacy of Quxie Capsule in Metastatic Colorectal Cancer: Long-Term Survival Update of A Double-Blind, Randomized, Placebo Controlled Trial.","OBJECTIVE


To verify the efficacy of Quxie Capsule in patients with metastatic colorectal cancer (mCRC).
METHODS


It was a block randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into 2 groups at a 1:1 ratio. The patients in the treatment group received conventional therapy including chemotherapy, radiotherapy, targeted therapy and supportive care, and Chinese herbal medicine combined with Quxie Capsule (each capsule of 0.4 g was orally administered at 50 mg/kg, twice daily, day 1-20, in a 30-day course) for 3 months. The patients in the control group received conventional therapy and Chinese herbal medicine combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Subgroup analysis was performed according to therapy lines, right or left-sided colon, targeted therapy and RAS gene status to determine the differences in PFS and OS between the two groups. Patients were followed up every 3 months until December 31st, 2018.
RESULTS


Median follow-up time was 19.4 months. The median OS was 23.9 months in the treatment group [95% confidence interval (CI) 15.9-28.5] vs. 14.3 months in the control group (95% CI 11.3-21.4, P<;0.05). Hazard ratio (95% CI) was 0.55 (0.31-0.95, P=0.040). There were no significant differences between the two groups in PFS (P>0.05). In the subgroups of ⩾second-line therapy, non-targeted therapy, RAS gene wild type and left-sided colon, the treatment group showed a significant survival benefit compared with the control group (P<;0.05 or P<;0.01), respectively.
CONCLUSION


Quxie Capsule can reduce the risk of death and prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733).",2021,The median OS was 23.9 months in the treatment group [95% confidence interval (CI) 15.9-28.5] vs. 14.3 months in the control group (,"['Sixty patients with mCRC', 'patients with metastatic colorectal cancer (mCRC', 'Metastatic Colorectal Cancer']","['conventional therapy including chemotherapy, radiotherapy, targeted therapy and supportive care, and Chinese herbal medicine combined with Quxie Capsule', 'Placebo', 'conventional therapy and Chinese herbal medicine combined with placebo', 'Quxie Capsule', 'placebo']","['survival benefit', 'overall survival (OS) and progression-free survival (PFS', 'risk of death', 'median OS', 'Hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2605254', 'cui_str': 'quxie'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",60.0,0.700076,The median OS was 23.9 months in the treatment group [95% confidence interval (CI) 15.9-28.5] vs. 14.3 months in the control group (,"[{'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Ling-Yun', 'Initials': 'LY', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Yu-Fei', 'Initials': 'YF', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. yyf93@vip.sina.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-3281-1']
2639,34755760,Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial.,"OBJECTIVE


To evaluate the clinical effects of early administration of fibrinogen concentrate in patients with severe trauma and hypofibrinogenemia.
METHODS


We conducted an open randomized feasibility trial between December 2015 and January 2017 in patients with severe trauma admitted to the emergency department of a large trauma center. Patients presented with hypotension, tachycardia, and FIBTEM findings suggestive of hypofibrinogenemia. The intervention group received fibrinogen concentrate (50 mg/kg), and the control group did not receive early fibrinogen replacement. The primary outcome was feasibility assessed as the proportion of patients receiving the allocated treatment within 60 min after randomization. The secondary outcomes were transfusion requirements and other exploratory outcomes. Randomization was performed using sequentially numbered and sealed opaque envelopes. ClinicalTrials.gov: NCT02864875.
RESULTS


Thirty-two patients were randomized (16 in each group). All patients received the allocated treatment within 60 min after randomization (100%, 95% confidence interval, 86.7%-100%). The median length of intensive care unit stay was shorter in the intervention group (8 days, interquartile range [IQR] 5.75-10.0 vs. 11 days, IQR 8.5-16.0; p=0.02). There was no difference between the groups in other clinical outcomes. No adverse effects related to treatment were recorded in either group.
CONCLUSION


Early fibrinogen replacement with fibrinogen concentrate was feasible. Larger trials are required to properly evaluate clinical outcomes.",2021,"All patients received the allocated treatment within 60 min after randomization (100%, 95% confidence interval, 86.7%-100%).","['patients with severe trauma and hypofibrinogenemia', 'Thirty-two patients', 'December 2015 and January 2017 in patients with severe trauma admitted to the emergency department of a large trauma center', 'patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia']","['fibrinogen concentrate', 'control group did not receive early fibrinogen replacement']","['median length of intensive care unit stay', 'adverse effects', 'interquartile range [IQR', 'transfusion requirements and other exploratory outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0553681', 'cui_str': 'Hypofibrinogenemia'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C3661505', 'cui_str': 'Thromboelastometry'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}]","[{'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",32.0,0.190947,"All patients received the allocated treatment within 60 min after randomization (100%, 95% confidence interval, 86.7%-100%).","[{'ForeName': 'Lucas Siqueira de', 'Initials': 'LS', 'LastName': 'Lucena', 'Affiliation': 'Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Roseny Dos Reis', 'Initials': 'RDR', 'LastName': 'Rodrigues', 'Affiliation': 'Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Maria José Carvalho', 'Initials': 'MJC', 'LastName': 'Carmona', 'Affiliation': 'Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Francisco José Diniz', 'Initials': 'FJD', 'LastName': 'Noronha', 'Affiliation': 'Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Heleno de Paiva', 'Initials': 'HP', 'LastName': 'Oliveira', 'Affiliation': 'Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Natalia Martins', 'Initials': 'NM', 'LastName': 'Lima', 'Affiliation': 'Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Rodrigo Brandão', 'Initials': 'RB', 'LastName': 'Pinheiro', 'Affiliation': 'Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Wallace Andrino da', 'Initials': 'WAD', 'LastName': 'Silva', 'Affiliation': 'Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2021/e3168']
2640,34755758,Evaluating the Efficacy of VitalStim Electrical Stimulation Combined with Swallowing Function Training for Treating Dysphagia following an Acute Stroke.,"OBJECTIVES


This study explored the clinical efficacy of VitalStim electrical stimulation combined with swallowing function training for patients with dysphagia following an acute stroke.
METHODS


Seventy-two patients with dysphagia following an acute stroke were admitted to our hospital and were further divided into two groups using prospective research methods. There were 36 cases in each group according to the random number table method. The control group received conventional medical treatment and swallowing function training while the experimental group received conventional medical treatment and VitalStim electrical stimulation combined with swallowing function training.
RESULTS


The overall response rate of the experimental group (94.44%) was higher than that of the control group (77.78%), and the difference was statistically significant (p<0.05). Compared with before treatment, the upward and forward movement speeds of the hyoid bone, anterior movement speed, the grading score of the Kubota drinking water test, Caiteng's grading score, serum superoxide dismutase, 5-hydroxytryptamine, and norepinephrine levels, Fugl-Meyer Assessment score, and multiple quality of life scores of the two groups showed improvement after treatment. While the standard swallowing assessment score, serum malondialdehyde level, and National Institutes of Health Stroke Scale score decreased, the aforementioned indices showed a significant improvement in the experimental group (p<0.05).
CONCLUSION


The results of this study indicate that VitalStim electrical stimulation combined with swallowing function is effective for treating dysphagia following an acute stroke. It can effectively improve swallowing, neurological, and limb motor functions, reduce complications, promote physical recovery, and improve overall quality of life of patients.",2021,"While the standard swallowing assessment score, serum malondialdehyde level, and National Institutes of Health Stroke Scale score decreased, the aforementioned indices showed a significant improvement in the experimental group (p<0.05).
","['patients with dysphagia following an acute stroke', 'Seventy-two patients with dysphagia following an acute stroke were admitted to our hospital and']","['VitalStim electrical stimulation combined with swallowing function training', 'VitalStim Electrical Stimulation Combined with Swallowing Function Training', 'conventional medical treatment and swallowing function training while the experimental group received conventional medical treatment and VitalStim electrical stimulation combined with swallowing function training', 'VitalStim electrical stimulation combined with swallowing function']","['overall quality of life', 'standard swallowing assessment score, serum malondialdehyde level, and National Institutes of Health Stroke Scale score', 'swallowing, neurological, and limb motor functions, reduce complications, promote physical recovery', ""Kubota drinking water test, Caiteng's grading score, serum superoxide dismutase, 5-hydroxytryptamine, and norepinephrine levels, Fugl-Meyer Assessment score, and multiple quality of life scores"", 'overall response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",72.0,0.0116024,"While the standard swallowing assessment score, serum malondialdehyde level, and National Institutes of Health Stroke Scale score decreased, the aforementioned indices showed a significant improvement in the experimental group (p<0.05).
","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Geriatric Rehabilitation, Cadre Sanatorium of Hainan & Geriatric Hospital of Hainan (CSH), Haikou, Hainan 571100, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Eldercare Services and Medical Care Area, Cadre Sanatorium of Hainan & Geriatric Hospital of Hainan (CSH), Haikou, Hainan 571100, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Medicine, Cadre Sanatorium of Hainan & Geriatric Hospital of Hainan (CSH), Haikou, Hainan 571100, China.'}, {'ForeName': 'Shufen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Geriatric Rehabilitation, Cadre Sanatorium of Hainan & Geriatric Hospital of Hainan (CSH), Haikou, Hainan 571100, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Cadre Sanatorium of Hainan & Geriatric Hospital of Hainan (CSH), Haikou, Hainan 571100, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Geriatric Rehabilitation, Cadre Sanatorium of Hainan & Geriatric Hospital of Hainan (CSH), Haikou, Hainan 571100, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Pediatric Area II, Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University, Haikou, Hainan 570311, China.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2021/e3069']
2641,34755702,Role of EUS at high risk for choledocholithiasis without severe cholangitis and visible stone on cross-sectional imaging: A multicenter randomized clinical trial.,"Background and Objectives


The prevalence of choledocholithiasis in the high-risk group of choledocholithiasis has been reported to be slightly more than 50% when there is no definite cholangitis. Replacement of diagnostic endoscopic retrograde cholangiography (ERC) with an EUS-first approach may be beneficial in these patients.
Materials and Methods


In this prospective, multicenter study, patients with dilated common bile duct and serum total bilirubin levels of 1.8-4 mg/dL were randomly allocated to undergo either EUS first, followed by subsequent ERC if necessary (EUS group) or ERC only (ERC group). The primary endpoint was the incidence of negative outcomes associated with a false-negative diagnosis of the choledocholithiasis or the endoscopic procedure. The secondary endpoints were the rate of diagnostic ERC and hospital stay length related to the endoscopic procedure.
Results


Of 90 patients who were randomly assigned, the final analysis involved 42 in the EUS group and 44 in the ERC group. The negative outcomes were not significantly different between the EUS and ERC groups (2.4% vs. 6.8%; P = 0.62). The rate of diagnostic ERC was significantly lower in the EUS group (2.4% vs. 47.7%; P < 0.001). The hospital stay length related to the endoscopic procedure was significantly shorter in the EUS group (1.8 ± 1.0 vs. 2.5 ± 1.2 days; P = 0.001).
Conclusion


In selected high-risk choledocholithiasis patients, an EUS-first strategy significantly decreased the rate of diagnostic ERC and hospital stay but did not achieve a significant reduction in negative endoscopic procedure outcomes.",2021,The rate of diagnostic ERC was significantly lower in the EUS group (2.4% vs. 47.7%; P < 0.001).,"['patients with dilated common bile duct and serum total bilirubin levels of 1.8-4 mg/dL', '90 patients who were randomly assigned']","['EUS first, followed by subsequent ERC if necessary (EUS group) or ERC only (ERC group', 'EUS', 'diagnostic endoscopic retrograde cholangiography (ERC']","['negative outcomes', 'rate of diagnostic ERC', 'rate of diagnostic ERC and hospital stay', 'hospital stay length related to the endoscopic procedure', 'rate of diagnostic ERC and hospital stay length related to the endoscopic procedure', 'incidence of negative outcomes associated with a false-negative diagnosis of the choledocholithiasis or the endoscopic procedure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009437', 'cui_str': 'Common bile duct structure'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0193504', 'cui_str': 'Endoscopic retrograde cholangiography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0193504', 'cui_str': 'Endoscopic retrograde cholangiography'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0701818', 'cui_str': 'Cholelithiasis, Common Bile Duct'}]",90.0,0.0181675,The rate of diagnostic ERC was significantly lower in the EUS group (2.4% vs. 47.7%; P < 0.001).,"[{'ForeName': 'Young Hoon', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': ""Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine; Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Yoon Suk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, South Korea.'}, {'ForeName': 'Sang Hyub', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jun Hyuk', 'Initials': 'JH', 'LastName': 'Son', 'Affiliation': 'Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, South Korea.'}, {'ForeName': 'Ji Kon', 'Initials': 'JK', 'LastName': 'Ryu', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yong-Tae', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Woo Hyun', 'Initials': 'WH', 'LastName': 'Paik', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.'}]",Endoscopic ultrasound,['10.4103/EUS-D-20-00229']
2642,34755655,Omega-3 fatty acids and blood-based biomarkers in Alzheimer's disease and mild cognitive impairment: A randomized placebo-controlled trial.,"BACKGROUND


Increased serum levels of pro-inflammatory biomarkers are consistently associated with cognitive decline. The omega-3 unsaturated fatty acids (n-3 PUFAs) had been linked to slowing cognitive decline due to their potential anti-inflammatory effects. To our knowledge, the different regiments of pure DHA, pure EPA, and their combination on various associated symptoms of dementia, including a mild form of cognitive impairment (MCI) and Alzheimer's disease (AD), have never been studied.
METHODS


This multisite, randomized, double-blind, placebo-controlled trial was conducted at two veteran's retirement centers and one medical center in central Taiwan between 2013 and 2015. 163 MCI or AD patients were randomly assigned to placebo (n = 40), docosahexaenoic acid (DHA, 0.7 g/day, n = 41), eicosapentaenoic acid (EPA, 1.6 g/day, n = 40), or EPA (0.8 g/day) + DHA (0.35 g/day) (n = 42) group for 24 months. The results were measured as the cognitive and functional abilities, biochemical, and inflammatory cytokines profiles. Chi-square tests, two-sample t-test, ANOVA, and linear mixedeffects models were conducted with p < 0.05.
RESULTS


131 (80%) participants had completed the trial with all cognitive, functional, and mood status assessments. The statistically significant difference between the placebo and treatment groups was not determined, concerning the changes in cognitive, functional, and mood status scores, the biochemical profiles, and inflammatory cytokines levels. However, EPA was found to reduce the C-C motif ligands 4 (CCL4) level (p < 0.001). Additionally, EPA could reduce the constructional praxis (p < 0.05) and spoken language ability scores (p < 0.01), and DHA also reduced the spoken language ability score (p < 0.05).
CONCLUSION


Overall, n-3 PUFAs supplements did not reduce cognitive, functional, and depressive symptom outcomes, but spoken language ability and constructional praxis subitems of ADAS-cog. These findings show that attention to clinical heterogeneity in dementia is crucial when studying nutrients interventions, such as n-3 PUFAs. In addition, with small effect size CCL4 is a better indicator than other inflammatory cytokines for EPA treatment response.",2021,"Additionally, EPA could reduce the constructional praxis (p < 0.05) and spoken language ability scores (p < 0.01), and DHA also reduced the spoken language ability score (p < 0.05).
","['163 MCI or AD patients', ""two veteran's retirement centers and one medical center in central Taiwan between 2013 and 2015"", 'participants had completed the trial with all cognitive, functional, and mood status assessments', '131 (80', ""Alzheimer's disease and mild cognitive impairment""]","['eicosapentaenoic acid (EPA, 1.6', 'omega-3 unsaturated fatty acids (n-3 PUFAs', 'docosahexaenoic acid', 'Omega-3 fatty acids and blood-based biomarkers', 'n-3 PUFAs supplements', 'placebo', 'EPA']","['C-C motif ligands 4 (CCL4) level', 'constructional praxis', 'spoken language ability scores', 'cognitive, functional, and depressive symptom outcomes, but spoken language ability and constructional praxis subitems of ADAS-cog', 'cognitive and functional abilities, biochemical, and inflammatory cytokines profiles', 'spoken language ability score', 'cognitive, functional, and mood status scores, the biochemical profiles, and inflammatory cytokines levels']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0338046', 'cui_str': 'Residential home'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0424919', 'cui_str': 'Language spoken'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.798235,"Additionally, EPA could reduce the constructional praxis (p < 0.05) and spoken language ability scores (p < 0.01), and DHA also reduced the spoken language ability score (p < 0.05).
","[{'ForeName': 'Pan-Yen', 'Initials': 'PY', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry & Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan; Department of Psychiatry, Wei Gong Memorial Hospital, Miaoli, Taiwan.'}, {'ForeName': 'Chin', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': 'Department of Psychiatry & Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan; Good Day Psychiatric Clinic, Taichung, Taiwan.'}, {'ForeName': 'Senthil Kumaran', 'Initials': 'SK', 'LastName': 'Satyanarayanan', 'Affiliation': 'Department of Psychiatry & Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan; Institute of Chinese Medical Sciences, University of Macau, Macau, China.'}, {'ForeName': 'Lu-Ting', 'Initials': 'LT', 'LastName': 'Chiu', 'Affiliation': 'College of Medicine, China Medical University, Taichung, Taiwan; Management Office for Health Data, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Yu-Chuan', 'Initials': 'YC', 'LastName': 'Chien', 'Affiliation': 'Department of Psychiatry & Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chih-Pin', 'Initials': 'CP', 'LastName': 'Chuu', 'Affiliation': 'College of Medicine, China Medical University, Taichung, Taiwan; Institute of Cellular and System Medicine, National Health Research Institutes, Miaoli, Taiwan.'}, {'ForeName': 'Tsuo-Hung', 'Initials': 'TH', 'LastName': 'Lan', 'Affiliation': 'Tsaotun Psychiatric Center, Ministry of Health and Welfare, Nantou, Taiwan; Department of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Institue of Clinical Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Center for Neuropsychiatric Research, National Health Research Institutes, Miaoli, Taiwan. Electronic address: tosafish@gmail.com.'}, {'ForeName': 'Kuan-Pin', 'Initials': 'KP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry & Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan; An-Nan Hospital, China Medical University, Tainan, Taiwan. Electronic address: cobolsu@gmail.com.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2021.10.014']
2643,34755627,Efficacy and safety of maralixibat treatment in patients with Alagille syndrome and cholestatic pruritus (ICONIC): a randomised phase 2 study.,"BACKGROUND


Alagille syndrome is a rare genetic disease that often presents with severe cholestasis and pruritus. There are no approved drugs for management. Maralixibat, an apical, sodium-dependent, bile acid transport inhibitor, prevents enterohepatic bile acid recirculation. We evaluated the safety and efficacy of maralixibat for children with cholestasis in Alagille syndrome.
METHODS


ICONIC was a placebo-controlled, randomised withdrawal period (RWD), phase 2b study with open-label extension in children (aged 1-18 years) with Alagille syndrome (NCT02160782). Eligible participants had more than three times the normal serum bile acid (sBA) levels and intractable pruritus. After 18 weeks of maralixibat 380 μg/kg once per day, participants were randomly assigned (1:1) to continue maralixibat or receive placebo for 4 weeks. Subsequently, all participants received open-label maralixibat until week 48. During the long-term extension (204 weeks reported), doses were increased up to 380 μg/kg twice per day. The primary endpoint was the mean sBA change during the RWD in participants with at least 50% sBA reduction by week 18. Cholestastic pruritus was assessed using observer-rated, patient-rated, and clinician-rated 0-4 scales. The safety population was defined as all participants who had received at least one dose of maralixibat. This trial was registered with ClinicalTrials.gov, NCT02160782, and is closed to recruitment.
FINDINGS


Between Oct 28, 2014, and Aug 14, 2015, 31 participants (mean age 5·4 years [SD 4·25]) were enrolled and 28 analysed at week 48. Of the 29 participants who entered the randomised drug withdrawal period, ten (34%) were female and 19 (66%) were male. In the RWD, participants switched to placebo had significant increases in sBA (94 μmol/L, 95% CI 23 to 164) and pruritus (1·7 points, 95% CI 1·2 to 2·2), whereas participants who continued maralixibat maintained treatment effect. This study met the primary endpoint (least square mean difference -117 μmol/L, 95% CI -232 to -2). From baseline to week 48, sBA (-96 μmol/L, -162 to -31) and pruritus (-1·6 pts, -2·1 to -1·1) improved. In participants who continued to week 204 (n=15) all improvements were maintained. Maralixibat was generally safe and well tolerated throughout. The most frequent adverse events were gastrointestinal related. Most adverse events were self-limiting in nature and mild-to-moderate in severity.
INTERPRETATION


In children with Alagille syndrome, maralixibat is, to our knowledge, the first agent to show durable and clinically meaningful improvements in cholestasis. Maralixibat might represent a new treatment paradigm for chronic cholestasis in Alagille syndrome.
FUNDING


Mirum Pharmaceuticals.",2021,In participants who continued to week 204 (n=15) all improvements were maintained.,"['29 participants who entered the randomised drug withdrawal period, ten (34%) were female and 19 (66%) were male', 'patients with Alagille syndrome and cholestatic pruritus (ICONIC', 'Between Oct 28, 2014, and Aug 14, 2015, 31 participants (mean age 5·4 years [SD 4·25]) were enrolled and 28 analysed at week 48', 'children (aged 1-18 years) with Alagille syndrome (NCT02160782', 'participants who had received at least one dose of maralixibat', 'children with cholestasis in Alagille syndrome']","['maralixibat treatment', 'placebo', 'continue maralixibat or receive placebo']","['sBA', 'pruritus', 'safety and efficacy', 'Efficacy and safety', 'safe and well tolerated', 'Cholestastic pruritus', 'normal serum bile acid (sBA) levels and intractable pruritus', 'mean sBA change']","[{'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0038587', 'cui_str': 'Withdrawal syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085280', 'cui_str': 'Arteriohepatic dysplasia'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008370', 'cui_str': 'Cholestasis'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.410833,In participants who continued to week 204 (n=15) all improvements were maintained.,"[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Gonzales', 'Affiliation': ""Hépatologie et Transplantation Hépatique Pédiatriques, Centre de référence de l'atrésie des voies biliaires et des cholestases génétiques, FSMR FILFOIE, ERN RARE LIVER, Hôpital Bicêtre, AP-HP, Université Paris-Saclay, Hépatinov, Inserm U 1193, Le Kremlin-Bicêtre, France. Electronic address: emmanuel.gonzales@aphp.fr.""}, {'ForeName': 'Winita', 'Initials': 'W', 'LastName': 'Hardikar', 'Affiliation': ""Department of Gastroenterology, The Royal Children's Hospital Melbourne, Parkville, VIC, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stormon', 'Affiliation': ""Department of Gastroenterology, The Children's Hospital at Westmead, Sydney, NSW, Australia.""}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': ""Department of Child Health, The Paediatric Liver Centre, King's College Hospital, London, UK.""}, {'ForeName': 'Loreto', 'Initials': 'L', 'LastName': 'Hierro', 'Affiliation': 'Servicio de Hepatologìa y Trasplante Pediátrico, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Gliwicz', 'Affiliation': ""Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Lacaille', 'Affiliation': 'Gastroenterology-Hepatology-Nutrition Unit, Hôpital Universitaire Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Lachaux', 'Affiliation': ""Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques, Centre de référence de la maladie de Wilson et autres maladies rares liées au cuivre, Centre de référence de l'atrésie des voies biliaires et cholestases génétiques, Hôpital Femme-Mère-Enfant, Lyon, France.""}, {'ForeName': 'Ekkehard', 'Initials': 'E', 'LastName': 'Sturm', 'Affiliation': 'Paediatric Gastroenterology/Hepatology, University Hospital for Children and Adolescents, Tübingen, Germany.'}, {'ForeName': 'Kenneth D R', 'Initials': 'KDR', 'LastName': 'Setchell', 'Affiliation': ""Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Kennedy', 'Affiliation': 'Amplyx Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Dorenbaum', 'Affiliation': 'Pediatrics - Immunology and Allergy, Stanford Medical School, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Steinmetz', 'Affiliation': 'Biostatistics, Premier Research, Naperville, IL, USA.'}, {'ForeName': 'Nirav K', 'Initials': 'NK', 'LastName': 'Desai', 'Affiliation': 'Takeda Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Wardle', 'Affiliation': 'Mirum Pharmaceuticals, Foster City, CA, USA.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Garner', 'Affiliation': 'Mirum Pharmaceuticals, Foster City, CA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Vig', 'Affiliation': 'Mirum Pharmaceuticals, Foster City, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaecklin', 'Affiliation': 'Mirum Pharmaceuticals, Basel, Switzerland.'}, {'ForeName': 'Etienne M', 'Initials': 'EM', 'LastName': 'Sokal', 'Affiliation': 'UCLouvain, Cliniques Universitaires Saint Luc, Service de Gastroentérologie Hépatologie Pédiatrique, Brussels, Belgium.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Jacquemin', 'Affiliation': ""Hépatologie et Transplantation Hépatique Pédiatriques, Centre de référence de l'atrésie des voies biliaires et des cholestases génétiques, FSMR FILFOIE, ERN RARE LIVER, Hôpital Bicêtre, AP-HP, Université Paris-Saclay, Hépatinov, Inserm U 1193, Le Kremlin-Bicêtre, France.""}]","Lancet (London, England)",['10.1016/S0140-6736(21)01256-3']
2644,34755569,Acupuncture combined with opioids for cancer pain: a pilot pragmatic randomized controlled trial.,"OBJECTIVE


Given the existing evidence for the analgesic effect of acupuncture, the current study aimed to assess whether acupuncture could be feasible and manageable as an adjunctive therapy for cancer pain in a real-world hospital setting.
METHODS


Thirty patients in an Oncology department with moderate or severe pain were recruited and randomized to an adjunctive acupuncture group or control group, who received pharmacotherapy for pain management without acupuncture. The duration of the treatment course was 1 week with a 2-week follow-up. In total, four acupuncture sessions were administered, on days 1/2/4/6 of the trial. Pain intensity was measured using a numerical rating scale (NRS) and the daily opioid dose was recorded.
RESULTS


The overall trends favored acupuncture for both pain intensity and daily opioid consumption. The proportion of participants experiencing at least a 2-point reduction in the NRS at the end of the treatment was 93% (n = 14/15) for the acupuncture group and 57% (n = 8/14) for the control group (risk difference (RD) 36.1%, 95% confidence interval (CI) [7.4%-65.0%]; relative risk (RR) 1.63, 95% CI [1.02-2.62]; p = 0.04). There were no serious adverse events and no dropouts during the treatment.
CONCLUSION


This pilot study showed that adding acupuncture to routine analgesia for patients with cancer pain was feasible and acceptable to patients. The clinical effects of adding acupuncture as an adjunctive therapy need to be further evaluated.
CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR1800017023 (Chinese Clinical Trial Registry).",2021,"There were no serious adverse events and no dropouts during the treatment.
","['cancer pain', 'Thirty patients in an Oncology department with moderate or severe pain', 'patients with cancer pain']","['acupuncture', 'adjunctive acupuncture group or control group, who received pharmacotherapy for pain management without acupuncture', 'Acupuncture combined with opioids']","['pain intensity and daily opioid consumption', 'numerical rating scale (NRS', 'serious adverse events', 'Pain intensity']","[{'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.537557,"There were no serious adverse events and no dropouts during the treatment.
","[{'ForeName': 'Yihan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'China-Australia International Research Centre for Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Yifang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Traditional Therapy, Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Shunqin', 'Initials': 'S', 'LastName': 'Long', 'Affiliation': 'Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Shujing', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'May', 'Affiliation': 'China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Melbourne, VIC, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lin Zhang', 'Affiliation': 'China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Melbourne, VIC, Australia.'}, {'ForeName': 'Xinfeng', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'China-Australia International Research Centre for Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Charlie Changli', 'Initials': 'CC', 'LastName': 'Xue', 'Affiliation': 'China-Australia International Research Centre for Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Chuanjian', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'China-Australia International Research Centre for Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/09645284211056016']
2645,34755994,Comparison of the influence the amount of sterile normal saline solution in reducing the postoperative complications after third molar surgery.,"OBJECTIVE


This study aimed to determine the optimal amount of serum used for reducing complications after impacted lower third molar surgery.
METHODS


This study was performed as a randomized clinical trial with patients requiring mandibular third molar surgery. Patients with random selection were divided into 1of 3 intervention groups: intervention group A received 20 ml of normal saline 0.9% as irrigation solution of socket and B intervention group and C intervention group received 40 and 60ml of normal saline0.9%, respectively. Pain intensity, swelling, change in normal daily activities, General patient satisfaction were assessed on the 2 and 7 days after surgery. The pain was measured using a visual analog scale(VAS) and the number of analgesic tablets consumed. Data were analyzed using Kruskal-Wallis analysis and analysis of variance (ANOVA). P value<.05 was considered significant.
RESULTS


A total of 330 patients had a mean age of 25.6 years, 95% male .There was a significant difference between the amount of pain, swelling, satisfaction and change of mouth smell on the 2 and 7 days after surgery in the between 3 groups (P<0.05). There was no significant difference between the rate of change in the quality of life on the 2 and 7 days after surgery in the between 3 groups (P>0.05).
CONCLUSIONS


According to the findings of the present study, it seems that the use of low serum levels can reduce the amount of pain, general satisfaction and mouth smell after surgery and increase swelling scores.",2021,"There was no significant difference between the rate of change in the quality of life on the 2 and 7 days after surgery in the between 3 groups (P>0.05).
","['Patients with random selection', '330 patients had a mean age of 25.6 years', 'patients requiring mandibular third molar surgery', 'after third molar surgery']","['intervention group A received 20 ml of normal saline 0.9% as irrigation solution of socket and B intervention group and C intervention', 'sterile normal saline solution']","['quality of life', 'pain, swelling, satisfaction and change of mouth smell', 'pain', 'postoperative complications', 'pain, general satisfaction and mouth smell after surgery and increase swelling scores', 'Pain intensity, swelling, change in normal daily activities, General patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",330.0,0.0952494,"There was no significant difference between the rate of change in the quality of life on the 2 and 7 days after surgery in the between 3 groups (P>0.05).
","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Omidpanah', 'Affiliation': 'Department of Oral Medicine, School of Dentistry, Kermanshah University of Medical Sciences, Kermanshah, Iran - n.omidpanah20000@gmail.com.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Nazari', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Zareie', 'Affiliation': 'School of Dentistry, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Minerva dental and oral science,['10.23736/S2724-6329.21.04602-7']
2646,34755919,Working memory training in children with borderline intellectual functioning and neuropsychiatric disorders: a triple-blind randomised controlled trial.,"BACKGROUND


Poor working memory, lower IQ and maladaptive behaviour form a triple disability known to have negative effects on the academic and social development of children with borderline intellectual functioning (BIF; IQ: 70 < IQ < 85) and neuropsychiatric disorders [attention-deficit hyperactivity disorder (ADHD) and/or autism spectrum disorder (ASD)]. Treatment possibilities for these children are scarce and hardly evidence based. This study primarily investigated whether adaptive computerised working memory training (WMT) may lead to significantly more improvement on a non-trained visuospatial WM task compared with a non-adaptive control WMT (placebo) in children with BIF and neuropsychiatric disorders. As secondary outcome measures, we used the scores on several non-trained neuropsychological near-transfer and far-transfer tasks as well as behavioural measures.
METHOD


We conducted a triple-blind placebo-controlled randomised clinical trial in 72 children (aged 10;0-13;11 years, 53 boys, 19 girls) with BIF and comorbid neuropsychiatric disorders (ADHD = 37, ASD = 21, both = 14) that were referred to child and adolescent psychiatry care, between May 2012 and March 2019. Children completed the Dutch version of Cogmed WMT, either the adaptive training version or the non-adaptive placebo version, 25 sessions (30-45 min a day), for 5 weeks. The primary outcome measure was the score on a non-trained visuospatial working memory task. The primary outcome was measured before and directly after 5 weeks of WMT and again 6 months after training.
RESULTS


A total of 375 children were screened for eligibility and 72 were randomised. No significantly higher levels of improvement over time were found on our primary outcome measure in the experimental WMT group compared with the placebo control WMT, nor in the secondary (near-transfer and far-transfer tasks) or tertiary (behavioural measures) outcome measures. However, this study did show changes over time for these measurements for both the experimental and placebo conditions.
CONCLUSIONS


This study was unable to document superior training effects over time of an adaptive WMT in children with BIF and neuropsychiatric disorders, compared with a placebo (non-adaptive) WMT. The objectively documented changes over time in the non-adaptive WMT arm suggest that these children with persistent impairments in WM may benefit from a structured learning environment that is associated with improvement of neurocognitive functioning and coping strategies. Further research is needed to examine which elements of cognitive training may be useful for which specific patients and to study long-term effects of training.",2021,"No significantly higher levels of improvement over time were found on our primary outcome measure in the experimental WMT group compared with the placebo control WMT, nor in the secondary (near-transfer and far-transfer tasks) or tertiary (behavioural measures) outcome measures.","['children with BIF and neuropsychiatric disorders', '375 children were screened for eligibility and 72 were randomised', 'children with borderline intellectual functioning (BIF; IQ: 70', '72 children (aged 10;0-13;11\xa0years, 53 boys, 19 girls) with BIF and comorbid neuropsychiatric disorders (ADHD\xa0=\xa037, ASD\xa0=\xa021, both\xa0=\xa014) that were referred to child and adolescent psychiatry care, between May 2012 and March 2019', 'children with borderline intellectual functioning and neuropsychiatric disorders', 'and/or autism spectrum disorder (ASD']","['Working memory training', 'adaptive training version or the non-adaptive placebo', 'placebo', 'adaptive computerised working memory training (WMT', 'non-adaptive control WMT (placebo']","['neuropsychiatric disorders [attention-deficit hyperactivity disorder (ADHD', 'score on a non-trained visuospatial working memory task', 'scores on several non-trained neuropsychological near-transfer and far-transfer tasks as well as behavioural measures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006009', 'cui_str': 'Borderline intellectual disability'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1274032', 'cui_str': 'Child and adolescent psychiatry'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0729377', 'cui_str': 'Memory skills training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",72.0,0.141473,"No significantly higher levels of improvement over time were found on our primary outcome measure in the experimental WMT group compared with the placebo control WMT, nor in the secondary (near-transfer and far-transfer tasks) or tertiary (behavioural measures) outcome measures.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Roording-Ragetlie', 'Affiliation': 'Department of Mild Intellectual Disabilities, Karakter Child and Adolescent Psychiatry, Nijmegen, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Spaltman', 'Affiliation': 'Department of Mild Intellectual Disabilities, Karakter Child and Adolescent Psychiatry, Nijmegen, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'de Groot', 'Affiliation': 'Department of Mild Intellectual Disabilities, Karakter Child and Adolescent Psychiatry, Nijmegen, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Klip', 'Affiliation': 'Department of Mild Intellectual Disabilities, Karakter Child and Adolescent Psychiatry, Nijmegen, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Buitelaar', 'Affiliation': 'Department of Mild Intellectual Disabilities, Karakter Child and Adolescent Psychiatry, Nijmegen, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Slaats-Willemse', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12895']
2647,34755800,Multicomponent nursing program to prevent delirium in critically ill patients: a randomized clinical trial.,"OBJECTIVES


To determine the efficacy of a multicomponent nursing program to prevent delirium in critically ill patients.
METHODS


Parallel controlled randomized clinical trial to prevent delirium in 81 critically ill patients: 41 in the control group and 40 in the intervention group (intervention: spatial and temporal guidance, visual stimulus, auditive stimulus, and family support). Participants were recruited from September 2017 to March 2018 in the university hospital Los Comuneros, Bucaramanga, Colombia. Clinical Trials record NCT03215745.
RESULTS


The incidence of delirium was 5% in the intervention group and 24% in the control group. The relative risk was 0.20 (95% CI 0.05 to 0.88). The absolute risk reduction was 19.39% (95% CI 4.61 to 34.17) and the number needed to treat was 5 (95 CI % 3 to 26%).
CONCLUSION


The multicomponent nursing program is efficient to prevent delirium in critically ill patients.",2021,"The absolute risk reduction was 19.39% (95% CI 4.61 to 34.17) and the number needed to treat was 5 (95 CI % 3 to 26%).
","['critically ill patients', 'Participants were recruited from September 2017 to March 2018 in the university hospital Los Comuneros, Bucaramanga, Colombia', '81 critically ill patients']","['control group and 40 in the intervention group (intervention: spatial and temporal guidance, visual stimulus, auditive stimulus, and family support', 'Multicomponent nursing program', 'multicomponent nursing program']","['incidence of delirium', 'absolute risk reduction', 'number needed to treat']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}]",81.0,0.302592,"The absolute risk reduction was 19.39% (95% CI 4.61 to 34.17) and the number needed to treat was 5 (95 CI % 3 to 26%).
","[{'ForeName': 'Claudia Consuelo Torres', 'Initials': 'CCT', 'LastName': 'Contreras', 'Affiliation': 'Universidad de Santander (UDES), School of Health Sciences, Nursing Investigation Group EVEREST. Bucaramanga, Santander, Colombia.'}, {'ForeName': 'Astrid Nathalia Páez', 'Initials': 'ANP', 'LastName': 'Esteban', 'Affiliation': 'Universidad de Santander (UDES), School of Health Sciences, Nursing Investigation Group in Public Health. Bucaramanga, Santander, Colombia.'}, {'ForeName': 'Myriam Durán', 'Initials': 'MD', 'LastName': 'Parra', 'Affiliation': 'Universidad de Santander (UDES), School of Health Sciences, Nursing Investigation Group EVEREST. Bucaramanga, Santander, Colombia.'}, {'ForeName': 'Mayerli Katherine Rincón', 'Initials': 'MKR', 'LastName': 'Romero', 'Affiliation': 'Universidad de Santander (UDES), School of Health Sciences, Nursing Investigation Group EVEREST. Bucaramanga, Santander, Colombia.'}, {'ForeName': 'Carolina Giordani da', 'Initials': 'CGD', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Enfermagem, Programa de Pós-Graduação em Enfermagem. Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Nohora Paola Duarte', 'Initials': 'NPD', 'LastName': 'Buitrago', 'Affiliation': 'Universidad de Santander (UDES), School of Health Sciences, Nursing Investigation Group EVEREST. Bucaramanga, Santander, Colombia.'}]",Revista gaucha de enfermagem,['10.1590/1983-1447.2021.20200278']
2648,34755790,Influence of testing environment on static fatigue behavior of a glass and a polycrystalline ceramic.,"It aims on evaluate the effect of the test environment on static fatigue behavior of lithium disilicate-based (LD), and yttrium oxide-stabilized zirconia (YSZ) ceramics. Specimens of LD (IPS e.max CAD, Ivoclar Vivadent) and YSZ (IPS e.max ZirCAD MO, 3 mol% Y2O3, Ivoclar Vivadent) were randomly allocated into three groups: tested in air, inert (paraffin oil, Sigma Aldrich) or distilled water. The static fatigue test (n=15) was performed using a piston-on-three ball assembly, adapted from ISO 6872, as follows: starting load 100 N for LD and 300 N for YSZ; loading application time set to 1 hour for each loading step; step size of 50 N for LD and 100 N for YSZ, applied successively until fracture. Data from static fatigue strength (MPa) and time to fracture (hours) were recorded. Fractographic analysis was executed. Survival analysis corroborates absence of influence of environment on static fatigue outcomes (fatigue strength, time to fracture and survival rates) for YSZ. For LD, specimens tested in air presented statistically superior survival rate and static fatigue strength (p= 0.025). In regards of time to fracture, LD tested in air were superior than when tested in distilled water (p=0.019) or inert (p=0.017) environments. No statistical differences for Weibull modulus were observed. Failures started on the tensile stress surface. Thus, the test environment did not affect slow crack growth (SCG) mechanisms during static fatigue test of YSZ ceramics, but it plays a significant role for the static fatigue behavior of lithium disilicate-based glass ceramics, indicating a high susceptibility to SCG.",2021,"For LD, specimens tested in air presented statistically superior survival rate and static fatigue strength (p= 0.025).",[],"['air, inert (paraffin oil, Sigma Aldrich) or distilled water', 'lithium disilicate-based (LD), and yttrium oxide-stabilized zirconia (YSZ) ceramics', 'static fatigue test (n=15) was performed using a piston-on-three ball assembly, adapted from ISO 6872, as follows: starting load 100 N for LD and 300 N for YSZ; loading application time set to 1 hour for each loading step; step size of 50 N for LD and 100 N for YSZ']","['static fatigue behavior', 'static fatigue outcomes (fatigue strength, time to fracture and survival rates', 'static fatigue strength (MPa) and time to fracture (hours', 'superior survival rate and static fatigue strength']",[],"[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0026156', 'cui_str': 'Mineral Oil'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}, {'cui': 'C0043194', 'cui_str': 'Wiskott-Aldrich syndrome'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0292957', 'cui_str': 'yttria'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0441230', 'cui_str': 'Ossicular piston prosthesis'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]",,0.0734049,"For LD, specimens tested in air presented statistically superior survival rate and static fatigue strength (p= 0.025).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fraga', 'Affiliation': 'Federal University of Rio Grande do Sul, Faculty of Dentistry, Department of Conservative Dentistry, Porto Alegre, RS, Brazil. sara.odonto@yahoo.com.br.'}, {'ForeName': 'Gabriel Kalil Rocha', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': 'Federal University of Santa Maria, Faculty of Dentistry, Department of Restorative Dentistry, Santa Maria, RS, Brazil. gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Luís Felipe', 'Initials': 'LF', 'LastName': 'Guilardi', 'Affiliation': 'Federal University of Santa Maria, Faculty of Dentistry, Department of Restorative Dentistry, Santa Maria, RS, Brazil. luisfguilardi@hotmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'Federal University of Santa Maria, Faculty of Dentistry, Department of Restorative Dentistry, Santa Maria, RS, Brazil. liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': '* Federal University of Santa Maria, Faculty of Dentistry, Department of Restorative Dentistry, Santa Maria, RS, Brazil. valandrolf@gmail.com.'}, {'ForeName': 'Cornelis Johannes', 'Initials': 'CJ', 'LastName': 'Kleverlaan', 'Affiliation': 'Academic Centre for Dentistry Amsterdam - ACTA, Department of Dental Materials Science, Universiteit van Amsterdam and Vrije Universiteit, Amsterdam, The Netherlands. c.kleverlaan@acta.nl.'}]",Brazilian dental journal,['10.1590/0103-6440202103961']
2649,34755786,Stability of early anterior open bite treatment: a 2-year follow-up randomized clinical trial.,"This 2-year-follow up study compared and evaluated the stability of early anterior open bite (AOB) treatment based on different appliances. Children from 7 to 10 years with Angle Class I, AOB larger than 1.0 mm and fully erupted maxillary and mandibular permanent central incisors were eligible. The initial sample was 99 patients distributed, by simple randomization, into four groups: BS (bonded spurs), CC (chincup), FPC (fixed palatal crib) and RPC (removable palatal crib). Cephalometric analysis was performed at baseline (T1), final (T2) and 2-year post-treatment (T3) by taking the overbite measurements as the main outcome. Blinding was possible to cephalometric analysis. At T3, with dropouts, there were 63 individuals, being BS (n=15; overbite 0.19 mm; 11.54 years; 10 female (F)/5 male (M)); CC (n=11; overbite -0.19 mm; 11.41 years; 8 F/3 M); FPC (n=21; overbite 1.23 mm; 11.44 years; 15 F/6 M) and; RPC (n=16; overbite 0.73 mm; 11.67 years; 6 F/10 M). Changes in dentoskeletal variables and breaking deleterious oral habits during the follow up were statically analyzed with p<.05. Mandibular skeletal linear measurements and vertical dental components have gradually increased with age, manly at pubertal growth spurt and at the establishment of permanent dentition after treatment. Incisor teeth extrusion had impact on AOB correction and stability in 4 groups, which recorded a 1.15 mm-improvement of overbite after treatment (T3-T2). The experimental appliances were effective with stable results, being FPC the device recorded the highest AOB correction and the lowest patient withdrawal rate.",2021,"Incisor teeth extrusion had impact on AOB correction and stability in 4 groups, which recorded a 1.15 mm-improvement of overbite after treatment (T3-T2).","['63 individuals, being BS (n=15; overbite 0.19 mm; 11.54 years; 10 female (F)/5 male (M)); CC (n=11; overbite -0.19 mm; 11.41 years; 8 F/3 M); FPC (n=21; overbite 1.23 mm; 11.44 years; 15 F/6 M) and; RPC (n=16; overbite 0.73 mm; 11.67 years; 6 F/10 M', 'Children from 7 to 10 years with Angle Class I, AOB larger than 1.0 mm and fully erupted maxillary and mandibular permanent central incisors were eligible']","['early anterior open bite treatment', 'BS (bonded spurs), CC (chincup), FPC (fixed palatal crib) and RPC (removable palatal crib']","['dentoskeletal variables and breaking deleterious oral habits', 'stability of early anterior open bite (AOB', 'AOB correction and stability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1305740', 'cui_str': 'Overbite'}, {'cui': 'C4517435', 'cui_str': '0.19'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0032580', 'cui_str': 'Adenomatous polyposis coli'}, {'cui': 'C4517495', 'cui_str': '1.23'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0399523', 'cui_str': 'Malocclusion, Angle class I'}, {'cui': 'C0266060', 'cui_str': 'Anterior open bite'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0266060', 'cui_str': 'Anterior open bite'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0032580', 'cui_str': 'Adenomatous polyposis coli'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0010317', 'cui_str': 'Crib'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0424439', 'cui_str': 'Oral habits'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0266060', 'cui_str': 'Anterior open bite'}]",99.0,0.0660577,"Incisor teeth extrusion had impact on AOB correction and stability in 4 groups, which recorded a 1.15 mm-improvement of overbite after treatment (T3-T2).","[{'ForeName': 'Flaviana Alves', 'Initials': 'FA', 'LastName': 'Dias', 'Affiliation': 'Department of Orthodontics, University of Northern Parana (UNOPAR), Brazil.'}, {'ForeName': 'Paula Vanessa Pedron', 'Initials': 'PVP', 'LastName': 'Oltramari', 'Affiliation': 'Department of Orthodontics, University of Northern Parana (UNOPAR), Brazil.'}, {'ForeName': 'Marcio Rodrigues de', 'Initials': 'MR', 'LastName': 'Almeida', 'Affiliation': 'Department of Orthodontics, University of Northern Parana (UNOPAR), Brazil.'}, {'ForeName': 'Ana Claúdia de Castro Ferreira', 'Initials': 'ACCF', 'LastName': 'Conti', 'Affiliation': 'Department of Orthodontics, University of Northern Parana (UNOPAR), Brazil.'}, {'ForeName': 'Renato Rodrigues de', 'Initials': 'RR', 'LastName': 'Almeida', 'Affiliation': 'Department of Orthodontics, University of Northern Parana (UNOPAR), Brazil.'}, {'ForeName': 'Thais Maria Freire', 'Initials': 'TMF', 'LastName': 'Fernandes', 'Affiliation': 'Department of Orthodontics, University of Northern Parana (UNOPAR), Brazil.'}]",Brazilian dental journal,['10.1590/0103-6440202103509']
2650,34755785,Coadministration of ibuprofen/caffeine on bleaching-induced tooth sensitivity: A randomized clinical trial.,"This clinical trial evaluated the effect of the coadministration of ibuprofen/caffeine on bleaching-induced tooth sensitivity (TS). A triple-blind, parallel-design, randomized clinical trial was conducted on 84 patients who received ibuprofen/caffeine or placebo capsules. The drugs were administered for 48 hours, starting 1 hour before the in-office bleaching. Two bleaching sessions were performed with 35% hydrogen peroxide gel with 1-week interval. TS was recorded up to 48 hours after dental bleaching with a 0-10 visual analogic scale (VAS) and a 5-point numeric rating scale (NRS). The color was evaluated with VITA Classical and VITA Bleachedguide scales (ΔSGU) and VITA Easyshade spectrophotometer (ΔE*ab and ΔE00). The absolute risk of TS in both groups was evaluated using Fischer's exact test. Comparisons of the TS intensity (NRS and VAS data) were performed by using the Mann-Whitney test and a two-way repeated measures ANOVA, respectively. The color alteration between the groups was compared with the Student's t test. The significance level was 5%. There was no statistically significant difference between the groups for the absolute risk of TS (p = 1.00) or for the intensity of TS (p > 0.05). A bleaching of approximately 7 shade guide units was observed on the Vita Classical and Vita Bleachedguide scales, with no statistical difference between the groups. It was concluded that coadministration of ibuprofen and caffeine did not reduce the absolute risk or intensity of TS and did not interfere with the efficacy of dental bleaching.",2021,There was no statistically significant difference between the groups for the absolute risk of TS (p = 1.00) or for the intensity of TS (p > 0.05).,['84 patients who received'],"['ibuprofen and caffeine', 'ibuprofen/caffeine or placebo capsules', 'ibuprofen/caffeine', 'hydrogen peroxide gel']","['VITA Classical and VITA Bleachedguide scales (ΔSGU) and VITA Easyshade spectrophotometer', 'Vita Classical and Vita Bleachedguide scales', 'absolute risk of TS', 'color alteration', 'bleaching-induced tooth sensitivity (TS', 'absolute risk or intensity of TS', 'bleaching-induced tooth sensitivity', 'TS intensity (NRS and VAS data', '5-point numeric rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",84.0,0.0585375,There was no statistically significant difference between the groups for the absolute risk of TS (p = 1.00) or for the intensity of TS (p > 0.05).,"[{'ForeName': 'Karine Letícia da', 'Initials': 'KLD', 'LastName': 'Silva', 'Affiliation': 'School of Dentistry. State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Elisama', 'Initials': 'E', 'LastName': 'Sutil', 'Affiliation': 'School of Dentistry. State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Hortkoff', 'Affiliation': 'School of Dentistry. State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Renata Maria Oleniki', 'Initials': 'RMO', 'LastName': 'Terra', 'Affiliation': 'School of Dentistry. State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Rezende', 'Affiliation': 'School of Dentistry. School Paulo Picanço, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'School of Dentistry. State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'School of Dentistry. State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Vilela', 'Affiliation': 'School of Pharmacy, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Paulo Vitor', 'Initials': 'PV', 'LastName': 'Farago', 'Affiliation': 'School of Pharmacy, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}]",Brazilian dental journal,['10.1590/0103-6440202104138']
2651,34756198,Delayed-intervention management of ingested Hijab pins.,,2020,,[],['ingested Hijab pins'],[],[],"[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]",[],,0.0248261,,"[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'The Hebrew University of Jerusalem Jerusalem, Israel.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Yerushalmi', 'Affiliation': 'Soroka University Medical Center Beersheba, Israel.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.059']
2652,34756180,"The clinical and microbiological efficacy of temocillin versus cefotaxime in adults with febrile urinary tract infection, and its effects on the intestinal microbiota: a randomised multicentre clinical trial in Sweden.","BACKGROUND


Use of third-generation cephalosporins, such as cefotaxime, is associated with an increased risk of selection for antimicrobial resistance, so alternative antibiotics need to be considered. The aim of the present study was to evaluate intestinal colonisation with third-generation cephalosporin-resistant pathogens following use of temocillin-an alternative antibiotic to cefotaxime that is potentially less prone to disturbing the intestinal microbiota-in empirical treatment of febrile urinary tract infection (UTI).
METHODS


We did a randomised, multicentre, superiority, open-label phase 4 trial in patients who had been admitted to inpatient care in 12 Swedish hospitals with suspected or diagnosed febrile UTI (complicated or uncomplicated). To meet inclusion criteria, a patient was required to have at least one sign or symptom of pyelonephritis (ie, flank pain; costovertebral angle tenderness; and changes to urinary frequency or urgency or dysuria), a fever of 38·0°C or higher, and a positive urine dipstick (for nitrites, white blood cells, or both). Participants were also required to have an indication for intravenous antibiotic treatment. Participants were randomly assigned (1:1) to receive either 2 g temocillin or 1-2 g cefotaxime, by local investigators opening consecutive sealed randomisation envelopes that were generated centrally in advance. Both drugs were administered intravenously every 8 h. The trial was open label for investigators and patients, but those doing the microbiological analyses were masked to the groups. Participants were treated with antibiotics for 7-10 days (or up to 14 days if they had bacteraemia), at least 3 days of which were on the study drug; at day 4 and later, participants who were showing improvement could be given an oral antibiotic (ciprofloxacin, ceftibuten, cefixime, or co-trimoxazole). Patients not showing improvement were regarded as having treatment failures. Rectal swabs were collected at three timepoints: at baseline (before the first dose), after the last dose of study drug, and 7-10 days after treatment stopped. The composite primary outcome was colonisation with Enterobacterales with reduced susceptibility to third-generation cephalosporins, or colonisation with toxin-producing Clostridioides difficile, or both, to evaluate disturbance of the intestinal microbiota. The study is registered in the EU Clinical Trials Register (EudraCT 2015-003898-15).
FINDINGS


Between May 20, 2016, and July 31, 2019, 207 patients were screened for eligibility, of whom 55 patients were excluded. 152 participants were randomly assigned to groups: 77 (51%) patients received temocillin, 75 (49%) patients received cefotaxime. The composite primary endpoint was met by 18 (26%) of 68 participants receiving temocillin versus 30 (48%) of 62 patients receiving cefotaxime (risk difference -22% [95% CI -42% to -3%]), showing superiority of temocillin versus cefotaxime (ie, less disturbance of the intestinal microbiota). 43 adverse events were reported in 40 (52%) of 77 patients in the temocillin group, versus 46 adverse events in 34 (45%) of 75 patients in the cefotaxime group. Most events were of mild to moderate severity. 21 (27%) patients in the temocillin and 17 (23%) patients in the cefotaxime group had an adverse event that was considered to be associated with the study drug.
INTERPRETATION


Temocillin was found to be less selective than cefotaxime of Enterobacterales with reduced susceptibility to third-generation cephalosporins, and it could therefore be a favourable alternative in the empirical treatment of febrile UTI. Use of this antibiotic could reduce hospital transmission and health-care-associated infections by these pathogens.
FUNDING


Public Health Agency of Sweden.",2021,"INTERPRETATION


Temocillin was found to be less selective than cefotaxime of Enterobacterales with reduced susceptibility to third-generation cephalosporins, and it could therefore be a favourable alternative in the empirical treatment of febrile UTI.","['152 participants', '207 patients were screened for eligibility, of whom 55 patients were excluded', 'Between May 20, 2016, and July 31, 2019', 'adults with febrile urinary tract infection', 'patient was required to have at least one sign or symptom of pyelonephritis (ie, flank pain; costovertebral angle tenderness; and changes to urinary frequency or urgency or dysuria), a fever of 38·0°C or higher, and a positive urine dipstick (for nitrites, white blood cells, or both', 'patients who had been admitted to inpatient care in 12 Swedish hospitals with suspected or diagnosed febrile UTI (complicated or uncomplicated']","['2 g temocillin or 1-2 g cefotaxime', 'antibiotics', 'temocillin versus cefotaxime', 'oral antibiotic (ciprofloxacin, ceftibuten, cefixime, or co-trimoxazole', 'cefotaxime']","['colonisation with Enterobacterales with reduced susceptibility to third-generation cephalosporins, or colonisation with toxin-producing Clostridioides difficile, or both, to evaluate disturbance of the intestinal microbiota', '43 adverse events', 'adverse event']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3875265', 'cui_str': 'Febrile urinary tract infection'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034186', 'cui_str': 'Pyelonephritis'}, {'cui': 'C0016199', 'cui_str': 'Flank pain'}, {'cui': 'C0235634', 'cui_str': 'Renal angle tenderness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0076079', 'cui_str': 'temocillin'}, {'cui': 'C0007554', 'cui_str': 'Cefotaxime'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0055014', 'cui_str': 'ceftibuten'}, {'cui': 'C0060400', 'cui_str': 'Cefixime'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0304320', 'cui_str': 'Third generation cephalosporin'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",152.0,0.208314,"INTERPRETATION


Temocillin was found to be less selective than cefotaxime of Enterobacterales with reduced susceptibility to third-generation cephalosporins, and it could therefore be a favourable alternative in the empirical treatment of febrile UTI.","[{'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Edlund', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ternhag', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden; Division of Infectious Diseases, Department of Medicine, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Skoog Ståhlgren', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Edquist', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Östholm Balkhed', 'Affiliation': 'Division of Infectious Diseases, Department of Biomedical and Clinical Sciences, Faculty of Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Athlin', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Emeli', 'Initials': 'E', 'LastName': 'Månsson', 'Affiliation': 'Department of Infectious Diseases and Centre of Clinical Research, Västmanland Hospital, Västerås, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tempé', 'Affiliation': 'Sundsvall Härnösand Regional Hospital, Sundsvall, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Bergström', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Giske', 'Affiliation': 'Division of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet, Solna, Sweden; Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Hanberger', 'Affiliation': 'Division of Infectious Diseases, Department of Biomedical and Clinical Sciences, Faculty of Medicine, Linköping University, Linköping, Sweden. Electronic address: hakan.hanberger@liu.se.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00407-2']
2653,34756178,"Effect of anti-interleukin drugs in patients with COVID-19 and signs of cytokine release syndrome (COV-AID): a factorial, randomised, controlled trial.","BACKGROUND


Infections with SARS-CoV-2 continue to cause significant morbidity and mortality. Interleukin (IL)-1 and IL-6 blockade have been proposed as therapeutic strategies in COVID-19, but study outcomes have been conflicting. We sought to study whether blockade of the IL-6 or IL-1 pathway shortened the time to clinical improvement in patients with COVID-19, hypoxic respiratory failure, and signs of systemic cytokine release syndrome.
METHODS


We did a prospective, multicentre, open-label, randomised, controlled trial, in hospitalised patients with COVID-19, hypoxia, and signs of a cytokine release syndrome across 16 hospitals in Belgium. Eligible patients had a proven diagnosis of COVID-19 with symptoms between 6 and 16 days, a ratio of the partial pressure of oxygen to the fraction of inspired oxygen (PaO 2 :FiO 2 ) of less than 350 mm Hg on room air or less than 280 mm Hg on supplemental oxygen, and signs of a cytokine release syndrome in their serum (either a single ferritin measurement of more than 2000 μg/L and immediately requiring high flow oxygen or mechanical ventilation, or a ferritin concentration of more than 1000 μg/L, which had been increasing over the previous 24 h, or lymphopenia below 800/mL with two of the following criteria: an increasing ferritin concentration of more than 700 μg/L, an increasing lactate dehydrogenase concentration of more than 300 international units per L, an increasing C-reactive protein concentration of more than 70 mg/L, or an increasing D-dimers concentration of more than 1000 ng/mL). The COV-AID trial has a 2 × 2 factorial design to evaluate IL-1 blockade versus no IL-1 blockade and IL-6 blockade versus no IL-6 blockade. Patients were randomly assigned by means of permuted block randomisation with varying block size and stratification by centre. In a first randomisation, patients were assigned to receive subcutaneous anakinra once daily (100 mg) for 28 days or until discharge, or to receive no IL-1 blockade (1:2). In a second randomisation step, patients were allocated to receive a single dose of siltuximab (11 mg/kg) intravenously, or a single dose of tocilizumab (8 mg/kg) intravenously, or to receive no IL-6 blockade (1:1:1). The primary outcome was the time to clinical improvement, defined as time from randomisation to an increase of at least two points on a 6-category ordinal scale or to discharge from hospital alive. The primary and supportive efficacy endpoints were assessed in the intention-to-treat population. Safety was assessed in the safety population. This study is registered online with ClinicalTrials.gov (NCT04330638) and EudraCT (2020-001500-41) and is complete.
FINDINGS


Between April 4, and Dec 6, 2020, 342 patients were randomly assigned to IL-1 blockade (n=112) or no IL-1 blockade (n=230) and simultaneously randomly assigned to IL-6 blockade (n=227; 114 for tocilizumab and 113 for siltuximab) or no IL-6 blockade (n=115). Most patients were male (265 [77%] of 342), median age was 65 years (IQR 54-73), and median Systematic Organ Failure Assessment (SOFA) score at randomisation was 3 (2-4). All 342 patients were included in the primary intention-to-treat analysis. The estimated median time to clinical improvement was 12 days (95% CI 10-16) in the IL-1 blockade group versus 12 days (10-15) in the no IL-1 blockade group (hazard ratio [HR] 0·94 [95% CI 0·73-1·21]). For the IL-6 blockade group, the estimated median time to clinical improvement was 11 days (95% CI 10-16) versus 12 days (11-16) in the no IL-6 blockade group (HR 1·00 [0·78-1·29]). 55 patients died during the study, but no evidence for differences in mortality between treatment groups was found. The incidence of serious adverse events and serious infections was similar across study groups.
INTERPRETATION


Drugs targeting IL-1 or IL-6 did not shorten the time to clinical improvement in this sample of patients with COVID-19, hypoxic respiratory failure, low SOFA score, and low baseline mortality risk.
FUNDING


Belgian Health Care Knowledge Center and VIB Grand Challenges program.",2021,"INTERPRETATION


Drugs targeting IL-1 or IL-6 did not shorten the time to clinical improvement in this sample of patients with COVID-19, hypoxic respiratory failure, low SOFA score, and low baseline mortality risk.
","['patients with COVID-19 and signs of cytokine release syndrome (COV-AID', 'hospitalised patients with COVID-19, hypoxia, and signs of a cytokine release syndrome across 16 hospitals in Belgium', 'All 342 patients were included in the primary intention-to-treat analysis', 'Eligible patients had a proven diagnosis of COVID-19 with symptoms between 6 and 16 days, a ratio of the partial pressure of oxygen to the fraction of inspired oxygen (PaO 2 :FiO 2 ) of less than 350 mm Hg on room air or less than 280 mm Hg on supplemental oxygen, and signs of a cytokine release syndrome in their serum (either a single ferritin measurement of more than 2000 μg/L and immediately requiring high flow oxygen or mechanical ventilation, or a ferritin concentration of more than 1000 μg/L, which had been increasing over the previous 24 h, or lymphopenia below 800/mL with two of the following criteria: an increasing ferritin concentration of more than 700 μg/L, an increasing lactate dehydrogenase concentration of more than 300 international units per L, an increasing C-reactive protein concentration of more than 70 mg/L, or an increasing D-dimers concentration of more than 1000 ng/mL', 'Most patients were male (265 [77%] of 342), median age was 65 years (IQR 54-73), and', 'patients with COVID-19, hypoxic respiratory failure, and signs of systemic cytokine release syndrome', 'Between April 4, and Dec 6, 2020, 342 patients']","['tocilizumab (8 mg/kg) intravenously, or to receive no IL-6 blockade', 'anti-interleukin drugs', 'IL-1 blockade (n=112) or no IL-1 blockade', 'siltuximab', 'EudraCT', 'subcutaneous anakinra once daily (100 mg) for 28 days or until discharge, or to receive no IL-1 blockade', 'tocilizumab and 113 for siltuximab) or no IL-6 blockade', 'IL-6 blockade', 'Interleukin (IL)-1 and IL-6 blockade']","['estimated median time to clinical improvement', 'median time to clinical improvement', 'time to clinical improvement, defined as time from randomisation to an increase of at least two points on a 6-category ordinal scale or to discharge from hospital alive', 'median Systematic Organ Failure Assessment (SOFA) score', 'intention-to-treat population', 'Safety', 'mortality', 'incidence of serious adverse events and serious infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0948245', 'cui_str': 'Cytokine release syndrome'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0743912', 'cui_str': 'Ferritin increased'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C1609931', 'cui_str': 'siltuximab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",342.0,0.600646,"INTERPRETATION


Drugs targeting IL-1 or IL-6 did not shorten the time to clinical improvement in this sample of patients with COVID-19, hypoxic respiratory failure, low SOFA score, and low baseline mortality risk.
","[{'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Declercq', 'Affiliation': 'Laboratory of Mucosal Immunology, VIB-UGhent Center for Inflammation Research, Ghent University, Ghent, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Pulmonary Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Karel F A', 'Initials': 'KFA', 'LastName': 'Van Damme', 'Affiliation': 'Laboratory of Mucosal Immunology, VIB-UGhent Center for Inflammation Research, Ghent University, Ghent, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Pulmonary Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'De Leeuw', 'Affiliation': 'Laboratory of Mucosal Immunology, VIB-UGhent Center for Inflammation Research, Ghent University, Ghent, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Pulmonary Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Maes', 'Affiliation': 'Laboratory of Mucosal Immunology, VIB-UGhent Center for Inflammation Research, Ghent University, Ghent, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Pulmonary Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bosteels', 'Affiliation': 'Laboratory of Mucosal Immunology, VIB-UGhent Center for Inflammation Research, Ghent University, Ghent, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Pulmonary Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Tavernier', 'Affiliation': 'Laboratory of Mucosal Immunology, VIB-UGhent Center for Inflammation Research, Ghent University, Ghent, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Primary Immunodeficiency Research Laboratory, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'De Buyser', 'Affiliation': 'Biostatistics Unit, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Roos', 'Initials': 'R', 'LastName': 'Colman', 'Affiliation': 'Biostatistics Unit, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Hites', 'Affiliation': 'Clinic of Infectious Diseases, Cliniques Universitaires de Bruxelles, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Verschelden', 'Affiliation': 'Clinic of Infectious Diseases, Cliniques Universitaires de Bruxelles, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Fivez', 'Affiliation': 'Intensive Care Unit, ZOL Genk General Hospital, Genk, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Moerman', 'Affiliation': 'Department of Infectious Diseases, CHR de La Citadelle General Hospital, Liège, Belgium.'}, {'ForeName': 'Ingel K', 'Initials': 'IK', 'LastName': 'Demedts', 'Affiliation': 'Department of Pulmonary Medicine, AZ Delta General Hospital, Roeselare, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dauby', 'Affiliation': 'Institute for Medical Immunology, Université Libre de Bruxelles and CHU Saint-Pierre University Hospital, Brussels, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'De Schryver', 'Affiliation': 'Intensive Care Unit, Clinique Saint-Pierre, Ottignies, Belgium.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Govaerts', 'Affiliation': 'Department of Pulmonary Medicine, AZ Sint-Lucas General Hospital, Ghent, Belgium.'}, {'ForeName': 'Stefaan J', 'Initials': 'SJ', 'LastName': 'Vandecasteele', 'Affiliation': 'Department of Infectious Diseases, AZ Sint-Jan Brugge-Oostende, Brugge, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Van Laethem', 'Affiliation': 'Department of Internal Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Anguille', 'Affiliation': 'Department of Hematology, University Hospital Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'van der Hilst', 'Affiliation': 'Department of Infectious Diseases and Immune Pathology, Jessa General Hospital and Limburg Clinical Research Center, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Misset', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital, Liège, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Slabbynck', 'Affiliation': 'Department of Pulmonary Medicine, ZNA General Hospital, Antwerp, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Wittebole', 'Affiliation': 'Intensive Care Unit, Saint Luc University Hospital, UC Louvain, Brussels, Belgium.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Liénart', 'Affiliation': 'Department of Internal Medicine, CHU Tivoli University Hospital, La Louvière, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Legrand', 'Affiliation': 'Institute of Statistics, Biostatistics and Actuarial Sciences (ISBA), Louvain Institute for Data Analysis and Modeling, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Buyse', 'Affiliation': '(22)IDDI, Louvain-la-Neuve, and Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt, Belgium.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Stevens', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Pulmonary Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Fre', 'Initials': 'F', 'LastName': 'Bauters', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Pulmonary Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Leen J M', 'Initials': 'LJM', 'LastName': 'Seys', 'Affiliation': 'Laboratory of Mucosal Immunology, VIB-UGhent Center for Inflammation Research, Ghent University, Ghent, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Aegerter', 'Affiliation': 'Laboratory of Mucosal Immunology, VIB-UGhent Center for Inflammation Research, Ghent University, Ghent, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Smole', 'Affiliation': 'Laboratory of Mucosal Immunology, VIB-UGhent Center for Inflammation Research, Ghent University, Ghent, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Bosteels', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Laboratory of ER Stress and Inflammation, VIB-UGhent Center for Inflammation Research, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Levi', 'Initials': 'L', 'LastName': 'Hoste', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Primary Immunodeficiency Research Laboratory, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Naesens', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Primary Immunodeficiency Research Laboratory, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Filomeen', 'Initials': 'F', 'LastName': 'Haerynck', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Primary Immunodeficiency Research Laboratory, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Linos', 'Initials': 'L', 'LastName': 'Vandekerckhove', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Infectious Diseases, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Depuydt', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Intensive Care Unit, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'van Braeckel', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Pulmonary Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Rottey', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Drug Research Unit, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Peene', 'Affiliation': 'Department of Rheumatology, AZ Sint-Jan Brugge-Oostende, Brugge, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Van Der Straeten', 'Affiliation': 'Health Innovation Research, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hulstaert', 'Affiliation': 'Belgian Health Care Knowledge Centre, Brussels, Belgium.'}, {'ForeName': 'Bart N', 'Initials': 'BN', 'LastName': 'Lambrecht', 'Affiliation': 'Laboratory of Mucosal Immunology, VIB-UGhent Center for Inflammation Research, Ghent University, Ghent, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Pulmonary Medicine, University Hospital Ghent, Ghent, Belgium. Electronic address: bart.lambrecht@ugent.be.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00377-5']
2654,34756158,Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources.,"In this paper, a propensity score-integrated power prior approach is developed to augment the control arm of a two-arm randomized controlled trial (RCT) with subjects from multiple external data sources such as real-world data (RWD) and historical clinical studies containing subject-level outcomes and covariates. The propensity scores for the subjects in the external data sources versus the subjects in the RCT are first estimated, and then subjects are placed in different strata based on their estimated propensity scores. Within each propensity score stratum, a power prior is formulated with the information contributed by the external data sources, and Bayesian inference on the treatment effect is obtained. The proposed approach is implemented under the two-stage study design framework utilizing the outcome-free principle to ensure the integrity of a study. An illustrative example is provided to demonstrate the implementation of the proposed approach.",2021,The proposed approach is implemented under the two-stage study design framework utilizing the outcome-free principle to ensure the integrity of a study.,[],[],[],[],[],[],,0.0835007,The proposed approach is implemented under the two-stage study design framework utilizing the outcome-free principle to ensure the integrity of a study.,"[{'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Chenguang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Tiwari', 'Affiliation': '18426 Polynesian Lane, Boyds, Maryland 20841.'}, {'ForeName': 'Yunling', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Lilly Q', 'Initials': 'LQ', 'LastName': 'Yue', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2021.1998098']
2655,34756139,Epithelial Flap Corneal Cross-linking.,"PURPOSE


To compare standard epithelium-off corneal cross-linking (standard Epi-Off CXL) to corneal cross-linking with an epithelial flap (Epi-Flap CXL).
METHODS


Patients who had undergone sequential bilateral CXL for progressive keratoconus were included in this comparative interventional case series. One eye was treated with the Epi-Off CXL technique and the fellow eye with the Epi-Flap CXL technique. Postoperative pain was measured using the Verbal Rating Scale and corneal densitometry using a Scheimpflug camera. Sex, age, corrected distance visual acuity, keratometry, and corneal thickness were also recorded.
RESULTS


Twenty-four eyes of 12 patients with keratoconus with a mean age of 27.15 ± 5.15 years were included. The Verbal Rating Scale scores were significantly lower in patients who had Epi-Flap CXL on the first (1.00 [interquartile range (IQR): 0.00 to 1.00] vs 3.00 [IQR: 3.00 to 3.75],  P  = .01) and third (0.00 [IQR: 0.00 to 1.00] vs 1.00 [IQR: 0.00 to 1.00],  P  = .01) postoperative day compared to the Epi-Off CXL group. No pain was observed in both groups after the third day. After 12 months, the Epi-Flap CXL group showed significantly less anterior corneal haze (measured as corneal densitometry) compared to the patients treated with Epi-Off CXL ( P  = .01). Both groups demonstrated stability of keratometry and corneal thickness at 12 months after CXL ( P  < .01).
CONCLUSIONS


Epi-Flap CXL is associated with less postoperative pain and anterior stromal haze in patients undergoing CXL for progressive keratoconus with no loss of efficacy.  [ J Refract Surg . 2021;37(11):741-745.] .",2021,"CONCLUSIONS


Epi-Flap CXL is associated with less postoperative pain and anterior stromal haze in patients undergoing CXL for progressive keratoconus with no loss of efficacy.  ","['Patients who had undergone sequential bilateral CXL for progressive keratoconus', 'Twenty-four eyes of 12 patients with keratoconus with a mean age of 27.15 ± 5.15 years were included']","['standard epithelium-off corneal cross-linking (standard Epi-Off CXL) to corneal cross-linking with an epithelial flap (Epi-Flap CXL', 'Epi-Flap CXL', 'Epi-Off CXL technique and the fellow eye with the Epi-Flap CXL technique']","['Verbal Rating Scale and corneal densitometry', 'anterior corneal haze', 'Verbal Rating Scale scores', 'stability of keratometry and corneal thickness', 'Sex, age, corrected distance visual acuity, keratometry, and corneal thickness', 'Postoperative pain', 'No pain', 'postoperative pain and anterior stromal haze']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0011321', 'cui_str': 'Densitometry'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0010038', 'cui_str': 'Corneal opacity'}, {'cui': 'C4274441', 'cui_str': 'Verbal Rating Scale score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0234225', 'cui_str': 'No pain'}]",12.0,0.0307102,"CONCLUSIONS


Epi-Flap CXL is associated with less postoperative pain and anterior stromal haze in patients undergoing CXL for progressive keratoconus with no loss of efficacy.  ","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Borroni', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bonzano', 'Affiliation': ''}, {'ForeName': 'Rozaliya', 'Initials': 'R', 'LastName': 'Hristova', 'Affiliation': ''}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Rachwani-Anil', 'Affiliation': ''}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Sánchez-González', 'Affiliation': ''}, {'ForeName': 'Carlos Rocha', 'Initials': 'CR', 'LastName': 'de Lossada', 'Affiliation': ''}]","Journal of refractive surgery (Thorofare, N.J. : 1995)",['10.3928/1081597X-20210802-01']
2656,34756518,Efficacy of intraoperative sedation combined with preemptive analgesia for single-level kyphoplasty under local anesthesia: A randomized clinical trial.,"BACKGROUND


Kyphoplasty is widely used for Osteoporotic Vertebral Compression Fracture (OVCF) under general or local anesthesia, more attention was paid to its post-operative efficacy. Patients' pain and discomfort control strategies during surgery have not been taken seriously.
OBJECTIVE


This study aimed at assessing the efficacy of preoperative preemptive analgesia combined with intraoperative sedation for pain and tension relief in OVCF patients undergoing kyphoplasty under local anesthesia.
METHODS


We enrolled 128 patients with single-level OVCF who underwent kyphoplasty in our hospital from July 2013 to July 2016. The patients were randomly allocated into three groups: conventional group (i.e., local anesthesia with 0.5% lidocaine (1); n = 42), preemptive group (i.e, (1) + oral 200 mg Celecoxib on the night before surgery with intravenous 40 mg parecoxib sodium an hour before surgery (2); n = 43), and combined group (i.e., (1) + (2) + continuous intravenous 0.5 μg/kg/h dexmedetomidine intraoperatively; n = 43). Hemodynamic variations (heart rate, blood pressure, pulse oxygen saturation (SpO 2 )), Pain Visual Analogue Score (VAS), Ramsay score, and adverse events were recorded during perioperative period.
RESULTS


Blood pressure and heart rate were more stable with significantly smaller values in the combined group than in the conventional and preemptive groups both intra- and postoperatively. In contrast, SpO 2  showed no significant difference among the groups throughout the perioperative period. Intraoperative VAS scores revealed significant differences among the groups with the combined group having the smallest values followed by the preemptive group. Similarly, intraoperative Ramsay scores reflected significantly more favorable effects of sedation in the combined than in conventional group. Both VAS and Ramsay scores showed no significant differences among the groups postoperatively, and no differences in complication incidences were noted among the groups as well.
CONCLUSIONS


For kyphoplasty under local anesthesia for single-level OVCF, intraoperative sedation combined with preemptive analgesia worked better in mitigating pain and tension intraoperatively and in preventing hemodynamic changes intra- and post-operatively, as compared to local anesthesia alone or additional preemptive analgesia.",2021,"Both VAS and Ramsay scores showed no significant differences among the groups postoperatively, and no differences in complication incidences were noted among the groups as well.
","['single-level kyphoplasty under local anesthesia', 'OVCF patients undergoing kyphoplasty under local anesthesia', '128 patients with single-level OVCF who underwent kyphoplasty in our hospital from July 2013 to July 2016']","['preoperative preemptive analgesia combined with intraoperative sedation', 'conventional group (i.e., local anesthesia with 0.5% lidocaine (1); n\xa0=\xa042), preemptive group (i.e, (1)\xa0+ oral 200\xa0mg Celecoxib', 'parecoxib sodium an hour before surgery (2); n\xa0=\xa043), and combined group (i.e., (1)\xa0+ (2)\xa0+ continuous intravenous 0.5\xa0μg/kg/h dexmedetomidine', 'intraoperative sedation combined with preemptive analgesia']","['Intraoperative VAS scores', 'Hemodynamic variations (heart rate, blood pressure, pulse oxygen saturation (SpO 2 )), Pain Visual Analogue Score (VAS), Ramsay score, and adverse events', 'complication incidences', 'intraoperative Ramsay scores', 'pain and tension relief', 'Blood pressure and heart rate', 'VAS and Ramsay scores']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0915144', 'cui_str': 'Parecoxib sodium'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C2724208', 'cui_str': '++'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",128.0,0.111173,"Both VAS and Ramsay scores showed no significant differences among the groups postoperatively, and no differences in complication incidences were noted among the groups as well.
","[{'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, Shaanxi, 710061, China. Electronic address: zwren1980@163.com.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tahir', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, Shaanxi, 710061, China. Electronic address: elenatahir1993@gmail.com.""}, {'ForeName': 'Bobo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, Shaanxi, 710061, China. Electronic address: bo_bope@163.com.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, Shaanxi, 710061, China. Electronic address: wangying_ortho@163.com.""}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, Shaanxi, 710061, China. Electronic address: yymin_ortho@163.com.""}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2021.08.021']
2657,34756500,"Corrigendum to 'Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: Results from a multicentre, open-label, randomised, phase III study (COLUMBUS)' [European Journal of Cancer 152 (2021) 116-128].",,2021,,['patients with BRAF-mutant melanoma receiving the'],['combination encorafenib plus binimetinib'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]","[{'cui': 'C4079208', 'cui_str': 'encorafenib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3899947', 'cui_str': 'Binimetinib'}]",[],,0.118266,,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'National and Kapodistrian University of Athens, Laikon Hospital, Athens, Greece. Electronic address: helgogas@gmail.com.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University Hospital Zürich Skin Cancer Center, Zürich, Switzerland.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Unit of Medical Oncology, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Liszkay', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Eberhard Karls University, Tuebingen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Krajsová', 'Affiliation': 'University Hospital Prague and Charles University First Medical Faculty, Prague, Czech Republic.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion Sileni', 'Affiliation': 'Oncology Institute of Veneto IRCCS, Padua, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'University Hospital Centre Bordeaux, Hôpital Saint-Andre´, Bordeaux, France.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'University Medical Center, Mainz, Germany.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Queirolo', 'Affiliation': 'Division of Medical Oncology for Melanoma, Sarcoma, and Rare Tumors, IEO, European Institute of Oncology IRCCS, Milan, Italy; Ospedale Policlinico San Martino IRCCS, Genoa, Italy.'}, {'ForeName': 'Groot J', 'Initials': 'GJ', 'LastName': 'de Willem', 'Affiliation': 'Department of Medical Oncology, Isala Oncological Center, Zwolle, Netherlands.'}, {'ForeName': 'Abir T', 'Initials': 'AT', 'LastName': 'Sellier', 'Affiliation': 'Pierre Fabre Medicament, Boulogne-Billancourt, France.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Suissa', 'Affiliation': 'Pierre Fabre Medicament, Boulogne-Billancourt, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Murris', 'Affiliation': 'Pierre Fabre Medicament, Boulogne-Billancourt, France.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Gollerkeri', 'Affiliation': 'At Time of Research: Pfizer Inc., Boulder, CO, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Institute Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.10.002']
2658,34756489,Effect of Kinesio taping on wrist kinematics and functional performance: A randomized controlled trial.,"BACKGROUND


Kinesio taping (KT) is a popular adjunct treatment modality for musculoskeletal injuries, hand and wrist injuries. The effectiveness of KT on wrist kinematics has been analyzed during single plane movements in general, and no study has investigated its effectiveness during dart throwing motion (DTM).
PURPOSE


To compare the effects of different KT techniques on wrist kinematics during DTM and functional performance of hand in healthy participants.
STUDY DESIGN


Randomized, double-blind, placebo-controlled, crossover study.
METHODS


Seventy-two healthy participants were included. Dominant wrist kinematics during DTM was evaluated by a Leap motion controller and wrist functional performance was evaluated by Minnesota Manual Dexterity Test. In order to compare the effects of KT on different muscles and also the effects of KT and placebo taping (PT), wrists of participants were evaluated under 5 conditions: without any taping, KT on flexor carpi ulnaris (FCU), KT on extensor carpi radialis brevis and longus (ECRB/L), PT on FCU and PT on ECRB/L. Means of outcome measures without any taping and with different 4 tapings were compared by repeated measures analysis of variance. PT and KT effects were compared by Wilcoxon signed rank test.
RESULTS


DTM range increased (P = .0) and Minnesota Manual Dexterity Test time decreased (P = .0) after KT and PT applications on FCU and ECRB/L muscles. Amount of change in wrist kinematics (P = .0; effect size = 0.2 and 0.3) and functional performance (P = .0; effect size = 0.6 and 0.8) were more obvious with KT applications, independent from the muscles they were applied on (P = .2 for wrist kinematics and P = .7 for functional performance).
CONCLUSIONS


KT on either FCU or ECRB/L muscles improve wrist kinematics and functional performance, significantly. Further studies should investigate if these findings apply for the patients with different wrist injuries, for both immediate- and long-term effectiveness.",2021,"RESULTS


DTM range increased (P = .0) and Minnesota Manual Dexterity Test time decreased (P = .0) after KT and PT applications on FCU and ECRB/L muscles.","['healthy participants', 'Seventy-two healthy participants were included', 'patients with different wrist injuries']","['Kinesio taping', 'Kinesio taping (KT', 'KT techniques', 'KT', 'placebo', 'KT and placebo taping (PT']","['Minnesota Manual Dexterity Test time', 'flexor carpi ulnaris (FCU), KT on extensor carpi radialis brevis and longus (ECRB/L), PT on FCU and PT on ECRB/L. Means of outcome measures', 'PT and KT effects', 'wrist kinematics', 'wrist kinematics and functional performance', 'DTM range', 'functional performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043264', 'cui_str': 'Injury of wrist'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0224254', 'cui_str': 'Flexor carpi ulnaris muscle structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0336707', 'cui_str': 'Dart'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",72.0,0.115861,"RESULTS


DTM range increased (P = .0) and Minnesota Manual Dexterity Test time decreased (P = .0) after KT and PT applications on FCU and ECRB/L muscles.","[{'ForeName': 'Dilara Özen', 'Initials': 'DÖ', 'LastName': 'Oruk', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Muğla Sıtkı Koçman University, Muğla, Turkey.'}, {'ForeName': 'Mehmet Gürhan', 'Initials': 'MG', 'LastName': 'Karakaya', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Muğla Sıtkı Koçman University, Muğla, Turkey. Electronic address: karakaya70@yahoo.com.'}, {'ForeName': 'Semiha', 'Initials': 'S', 'LastName': 'Yenişehir', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Muğla Sıtkı Koçman University, Muğla, Turkey; Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Muş Alparslan University, Muş, Turkey.'}, {'ForeName': 'İlkim Çıtak', 'Initials': 'İÇ', 'LastName': 'Karakaya', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Muğla Sıtkı Koçman University, Muğla, Turkey.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2021.09.005']
2659,34756414,Comparison of vacuum sealing drainage and conventional drainage for postoperative drainage in closed calcaneal fracture: A randomized controlled trial.,"BACKGROUND


The objective of this study was to compare the outcomes of vacuum sealing drainage (VSD) and conventional drainage after surgery in the treatment of closed calcaneal fracture. We hypothesize that VSD is superior to conventional drainage in reducing volume of drainage, time of wound drying, time of skin fold, time of wound healing, VAS at day 3 postoperatively, wound complications and increasing wound healing grade.
METHODS


120 patients with closed calcaneal fractures from January 2016 to December 2018 were enrolled in our study. They were divided randomly into VSD group (n = 60) and conventional (n = 60). The volume of drainage, duration of drainage, time of wound drying, time of skin fold, time of wound healing and VAS at day 3 postoperatively were recorded. Furthermore, the wound complications of the two groups were also evaluated. Besides, wound healing grade was used to assess the degree of wound healing. The functional outcome American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot scores and visual analog scale (VAS) pain scores was also evaluated.
RESULTS


A total of 10 patients were lost to follow-up for various reasons, VSD group remained 55 cases while conventional group remained 53 cases. Our results showed that VSD group exhibited significantly more volume of drainage (P< 0.0001), longer duration of drainage (P< 0.0001), shorter time of wound drying (P = 0.0086), shorter time of skin fold (P = 0.0158), shorter time of wound healing (P = 0.0240) and lower VAS at day 3 postoperatively (P = 0.0019) compared with conventional group. Moreover, VSD group was demonstrated to have significantly lower wound complications (P = 0.025) and higher rate grade A of wound healing (P = 0.031). However, no significant difference was noted in time of fracture union (P = 0.754), VAS (P = 0.407) and AOFAS score (P = 0.512) at final follow-up between the two groups.
CONCLUSIONS


Our hypothesis was confirmed that VSD was superior in terms of some aspects than conventional drainage. Therefore, VSD is a safe and effective postoperative wound drainage method in the treatment of closed calcaneal fracture. However, more and higher evidence needs to be carried to demonstrate the results.",2021,"Moreover, VSD group was demonstrated to have significantly lower wound complications (P = 0.025) and higher rate grade A of wound healing (P = 0.031).","['closed calcaneal fracture', '120 patients with closed calcaneal fractures from January 2016 to December 2018 were enrolled in our study']","['vacuum sealing drainage (VSD) and conventional drainage', 'VSD', 'vacuum sealing drainage and conventional drainage']","['volume of drainage, duration of drainage, time of wound drying, time of skin fold, time of wound healing and VAS', 'longer duration of drainage', 'shorter time of wound healing', 'volume of drainage', 'functional outcome American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot scores and visual analog scale (VAS) pain scores', 'time of fracture union', 'AOFAS score', 'shorter time of wound drying', 'volume of drainage, time of wound drying, time of skin fold, time of wound healing, VAS at day 3 postoperatively, wound complications and increasing wound healing grade', 'wound complications', 'shorter time of skin fold', 'VAS', 'degree of wound healing', 'rate grade A of wound healing', 'lower VAS']","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",10.0,0.00804341,"Moreover, VSD group was demonstrated to have significantly lower wound complications (P = 0.025) and higher rate grade A of wound healing (P = 0.031).","[{'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Mei', 'Affiliation': ""Department of Emergency, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}, {'ForeName': 'Chunhui', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}, {'ForeName': 'Jinwu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}, {'ForeName': 'Xingyu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}, {'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China. Electronic address: zhengwenhao@wmu.edu.cn.""}]",Injury,['10.1016/j.injury.2021.10.018']
2660,34756350,Sodium bicarbonate improves sprint performance in endurance cycling.,"OBJECTIVES


Oral sodium bicarbonate intake (NaHCO 3 ) may improve performance in short maximal exercise by inducing metabolic alkalosis. However, it remains unknown whether NaHCO 3  also enhances all-out performance at the end of an endurance competition. Therefore, the present study investigated the effect of stacked NaHCO 3  loading on sprint performance following a 3-h simulated cycling race.
DESIGN


Double-blind randomized placebo-controlled cross-over study.
METHODS


Eleven trained male cyclists (22.3 (18.3-25.3) year; 73.0 (61.5-88) kg; VO 2 max: 63.7 (57-72) mlkg -1 min -1 ) ingested either 300mgkg -1  body weight NaHCO 3  (BIC) or NaCl (PL). NaHCO 3  or NaCl was supplemented prior to (150mgkg -1 ) and during (150mgkg -1 ) a 3-h simulated cycling race with a 90-s all-out sprint (90S) at the end. Capillary blood samples were collected for determination of blood pH, lactate and HCO 3 -  concentrations. Analysis of variance (lactate, pH, HCO 3 - ) and paired t-test (power) were applied to compare variables across condition (and time).
RESULTS


NaHCO 3  intake improved mean power during 90S by ∼3% (541±59W vs. 524±57W in PL, p=0.047, Cohen's D=0.28, medium). Peak blood lactate concentration and heart rate at the end of 90S were higher (p<0.05) in BIC (16.2±4.1mmoll 1 , 184±7bpm) than in PL (12.4±4.2mmoll -1 , 181±5bpm). NaHCO 3  ingestion increased blood [HCO 3 - ] (31.5±1.3 vs. 24.4±1.5mmoll -1  in PL, p<0.001) and blood pH (7.50±0.01 vs. 7.41±0.03 in PL, p<0.05) prior to 90S.
CONCLUSIONS


NaHCO 3  supplementation prior and during endurance exercise improves short all-out exercise performance at the end of the event. Therefore, sodium bicarbonate intake can be applied as a strategy to increase success rate in endurance competitions.",2020,"Peak blood lactate concentration and heart rate at the end of 90S were higher (p<0.05) in BIC (16.2±4.1mmoll 1 , 184±7bpm) than in PL (12.4±4.2mmoll -1 , 181±5bpm).","['endurance cycling', 'Eleven trained male cyclists (22.3 (18.3-25.3) year; 73.0 (61.5-88) kg; VO 2 max']","['Oral sodium bicarbonate intake (NaHCO 3 ', 'NaHCO 3  or NaCl', '300mgkg -1  body weight NaHCO 3  (BIC) or NaCl (PL', 'sodium bicarbonate', 'placebo', 'Sodium bicarbonate']","['mean power', 'sprint performance', 'NaHCO 3  ingestion increased blood [HCO 3 - ', 'blood pH', 'variance (lactate, pH, HCO 3 - ) and paired t-test (power', 'Peak blood lactate concentration and heart rate']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",11.0,0.117144,"Peak blood lactate concentration and heart rate at the end of 90S were higher (p<0.05) in BIC (16.2±4.1mmoll 1 , 184±7bpm) than in PL (12.4±4.2mmoll -1 , 181±5bpm).","[{'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Koppo', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hespel', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Belgium; Bakala Academy Athletic Performance Center, KU Leuven, Belgium. Electronic address: peter.hespel@kuleuven.be.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.09.011']
2661,34293527,Effects of single-dose L-theanine on motor cortex excitability.,,2021,,[],['single-dose L-theanine'],['motor cortex excitability'],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0076380', 'cui_str': 'theanine'}]","[{'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",,0.0921846,,"[{'ForeName': 'Shiwen', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Butler Hospital, Providence, RI, USA. Electronic address: shiwen_yuan@brown.edu.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Butler Hospital, Providence, RI, USA; Department of Neurology, Alpert Medical School of Brown University, Butler Hospital, Providence, RI, USA; Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC, USA; Department of Neurology, Medical University of South Carolina (MUSC), Charleston, SC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gold', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tirrell', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, RI, USA; Department of Neurology, Alpert Medical School of Brown University, RI, USA.'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Butler Hospital, Providence, RI, USA.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2021.07.003']
2662,34298539,Saliency-guided deep learning network for automatic tumor bed volume delineation in post-operative breast irradiation.,"Efficient, reliable and reproducible target volume delineation is a key step in the effective planning of breast radiotherapy. However, post-operative breast target delineation is challenging as the contrast between the tumor bed volume (TBV) and normal breast tissue is relatively low in CT images. In this study, we propose to mimic the marker-guidance procedure in manual target delineation. We developed a saliency-based deep learning segmentation (SDL-Seg) algorithm for accurate TBV segmentation in post-operative breast irradiation. The SDL-Seg algorithm incorporates saliency information in the form of markers' location cues into a U-Net model. The design forces the model to encode the location-related features, which underscores regions with high saliency levels and suppresses low saliency regions. The saliency maps were generated by identifying markers on CT images. Markers' location were then converted to probability maps using a distance transformation coupled with a Gaussian filter. Subsequently, the CT images and the corresponding saliency maps formed a multi-channel input for the SDL-Seg network. Our in-house dataset was comprised of 145 prone CT images from 29 post-operative breast cancer patients, who received 5-fraction partial breast irradiation (PBI) regimen on GammaPod. The 29 patients were randomly split into training (19), validation (5) and test (5) sets. The performance of the proposed method was compared against basic U-Net. Our model achieved mean (standard deviation) of 76.4(±2.7) %, 6.76(±1.83) mm, and 1.9(±0.66) mm for Dice similarity coefficient, 95 percentile Hausdorff distance, and average symmetric surface distance respectively on the test set with computation time of below 11 seconds per one CT volume. SDL-Seg showed superior performance relative to basic U-Net for all the evaluation metrics while preserving low computation cost. The findings demonstrate that SDL-Seg is a promising approach for improving the efficiency and accuracy of the on-line treatment planning procedure of PBI, such as GammaPod based PBI.",2021,SDL-Seg showed superior performance relative to basic U-Net for all the evaluation metrics while preserving low computation cost.,"['29 post-operative breast cancer patients', '29 patients']","['Saliency-guided deep learning network', 'saliency-based deep learning segmentation (SDL-Seg) algorithm', '5-fraction partial breast irradiation (PBI) regimen on GammaPod']",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]",[],29.0,0.0186526,SDL-Seg showed superior performance relative to basic U-Net for all the evaluation metrics while preserving low computation cost.,"[{'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Kazemimoghadam', 'Affiliation': 'Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Weicheng', 'Initials': 'W', 'LastName': 'Chi', 'Affiliation': 'Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Asal', 'Initials': 'A', 'LastName': 'Rahimi', 'Affiliation': 'Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Alluri', 'Affiliation': 'Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Nwachukwu', 'Affiliation': 'Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Stanford University, Palo Alto, CA, United States of America.'}]",Physics in medicine and biology,['10.1088/1361-6560/ac176d']
2663,32022434,Visual spatial learning outcomes for clinical trials in neurofibromatosis type 1.,"Cognitive problems are common in children with neurofibromatosis type 1, representing a significant source of lifelong morbidity. Assessment of cognitive function has been challenging in the setting of clinical trials. Spatial learning deficits may be an important target for cognitive interventions. We leveraged a large, international cognitive study in affected children with NF1 treated with lovastatin to assess spatial learning using the ""Arena Maze"", a portable, computerized task that allows for retesting in the same environment. As with the parent study, spatial learning assessed with this task did not improve with lovastatin treatment.",2020,"As with the parent study, spatial learning assessed with this task did not improve with lovastatin treatment.",['affected children with NF1 treated with'],['lovastatin'],['Visual spatial learning outcomes'],"[{'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0024027', 'cui_str': 'Lovastatin'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582587', 'cui_str': 'Visual learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0842568,"As with the parent study, spatial learning assessed with this task did not improve with lovastatin treatment.","[{'ForeName': 'Nicole J', 'Initials': 'NJ', 'LastName': 'Ullrich', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Payne', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Walsh', 'Affiliation': ""Center for Neuroscience and Behavioral Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'School of Public Health, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Packer', 'Affiliation': ""Center for Neuroscience and Behavioral Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'North', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Celiane', 'Initials': 'C', 'LastName': 'Rey-Casserly', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of clinical and translational neurology,['10.1002/acn3.50976']
2664,33020204,Phase 2 study of cetuximab (Erbitux) in patients with progressive or recurrent endometrial cancer.,"INTRODUCTION


Overexpression of the epidermal growth factor receptor (EGFR) found in common subtypes of endometrial cancer has been associated with advanced stage disease and a poor prognosis. The purpose of this phase 2 study was to evaluate the efficacy and safety of cetuximab in patients with recurrent endometrial cancer.
METHODS


The study was an open-label phase 2 clinical trial conducted at two institutions. Patients with recurrent or progressive endometrial cancer of any histologic type with the exception of uterine sarcoma received cetuximab at an initial dose of 400 mg/m 2  IV followed by weekly doses of 250 mg/m 2 . One cycle was considered 4 weeks of treatment. The primary efficacy endpoint was clinical benefit response, defined as a complete or partial response or prolonged stable disease (>8 weeks) by RECIST 1.0 criteria.
RESULTS


A total of 30 patients were enrolled with a median age of 64 years (range 42-83). Of the 20 evaluable patients, three (15%) had clinical benefit response (one complete response, two stable disease). The patient with a clinical benefit response received a total of 27 cycles and the two patients with stable disease were taken off the study due to progression after four and six cycles, respectively. Of the 10 inevaluable patients, nine received ≤1 cycle due to clinical deterioration and one had an anaphylactic reaction. One patient had a grade 3 rash which resolved after a delay in treatment. No dose reduction was reported.
CONCLUSIONS


In this cohort, single agent therapy with cetuximab was well tolerated and had a 15% clinical benefit response. Further studies are required to better identify patients who may respond to this treatment.",2020,"No dose reduction was reported.
","['patients with recurrent endometrial cancer', '30 patients were enrolled with a median age of 64 years (range 42-83', 'patients with progressive or recurrent endometrial cancer', 'Patients with recurrent or progressive endometrial cancer of any histologic type with the exception of uterine sarcoma received']","['cetuximab (Erbitux', 'cetuximab']","['anaphylactic reaction', 'clinical benefit response, defined as a complete or partial response or prolonged stable disease', 'efficacy and safety', 'grade 3 rash', 'clinical benefit response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278802', 'cui_str': 'Endometrial cancer recurrent'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0449574', 'cui_str': 'Histologic type'}, {'cui': 'C0338113', 'cui_str': 'Sarcoma of uterus'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1173436', 'cui_str': 'Erbitux'}]","[{'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",30.0,0.103046,"No dose reduction was reported.
","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Slomovitz', 'Affiliation': 'Division of Gynecologic Oncology, Broward Health Medical Center, Fort Lauderdale, Florida, USA.'}, {'ForeName': 'Anca', 'Initials': 'A', 'LastName': 'Chelariu-Raicu', 'Affiliation': 'Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Schmeler', 'Affiliation': 'Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Lu', 'Affiliation': 'Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Gershenson', 'Affiliation': 'Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA rcoleman@gog.org.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001859']
2665,33592205,Evolution of epitope-specific IgE and IgG 4  antibodies in children enrolled in the LEAP trial.,"BACKGROUND


In the LEAP (Learning Early About Peanut Allergy) trial, early consumption of peanut in high-risk infants was found to decrease the rate of peanut allergy at 5 years of age. Sequential epitope-specific (ses-)IgE is a promising biomarker of clinical peanut reactivity.
OBJECTIVE


We sought to compare the evolution of ses-IgE and ses-IgG 4  in children who developed (or not) peanut allergy and to evaluate the immunomodulatory effects of early peanut consumption on these antibodies.
METHODS


Sera from 341 children (LEAP cohort) were assayed at baseline, 1, 2.5, and 5 years of age, with allergy status determined by oral food challenge at 5 years. A bead-based epitope assay was used to quantitate ses-IgE and ses-IgG 4  to 64 sequential epitopes from Ara h 1 to Ara h 3 and was analyzed using linear mixed-effect models.
RESULTS


In children avoiding peanut who became peanut allergic, the bulk of peanut ses-IgE did not develop until after 2.5 years. Minimal increases of ses-IgE occurred after 1 year in consumers, but not to the same epitopes as those in children developing peanut allergy. No major changes in ses-IgE were seen in nonallergic or sensitized children. IgE in sensitized consumers was detected against peanut proteins. ses-IgG 4  increased over time in most children regardless of consumption or allergy status.
CONCLUSIONS


Early peanut consumption in infants at high risk of developing peanut allergy appears to divert the immunologic response to a presumably ""protective"" effect. In general, consumers tend to generate ses-IgG 4  earlier and in greater quantities than nonconsumers do, whereas only avoiders tend to generate significant quantities of ses-IgE.",2021,"Minimal increases of ses-IgE occurred after 1 year in consumers, but not to the same epitopes as those in children developing peanut allergy.","['341 children (LEAP cohort) were assayed at baseline, 1, 2.5, and 5 years of age, with allergy status determined by oral food challenge at 5 years', 'children who developed (or not) peanut allergy', 'infants at high risk of developing peanut allergy', 'children enrolled in the LEAP trial']","['Sequential epitope-specific', 'LEAP']","['rate of peanut allergy', 'ses-IgE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0003316', 'cui_str': 'Epitope'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0003316', 'cui_str': 'Epitope'}]",341.0,0.0881385,"Minimal increases of ses-IgE occurred after 1 year in consumers, but not to the same epitopes as those in children developing peanut allergy.","[{'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Suarez-Farinas', 'Affiliation': 'Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai, New York, NY; Center for Biostatistics, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Suprun', 'Affiliation': 'Division of Pediatric Allergy and Immunology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Bahnson', 'Affiliation': 'Benaroya Research Institute and the Immune Tolerance Network, Seattle, Wash.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Raghunathan', 'Affiliation': 'Center for Biostatistics, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Getts', 'Affiliation': 'AllerGenis LLC, Hatfield, Pa.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'duToit', 'Affiliation': ""Department of Pediatrics, St Thomas Hospital and King's College London, London, United Kingdom.""}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Lack', 'Affiliation': ""Department of Pediatrics, St Thomas Hospital and King's College London, London, United Kingdom.""}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'Division of Pediatric Allergy and Immunology, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: hugh.sampson@mssm.edu.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.01.030']
2666,33727428,Altered dopamine signalling in chronic epigastric pain syndrome.,"Chronic epigastric pain syndrome (CEPS) is an important diagnostic problem, especially in patients without macroscopic and microscopic changes in gastric mucosa. The cause of this ailment is unclear. The aim of this study was the assessment of coexistence between symptoms of this syndrome and secretion level of dopamine (DA), as well as the efficacy of peripheral and central D2 receptors antagonist. Sixty depressive patients with CEPS occurring independently of the diet and with no Helicobacter pylori infection and 30 healthy subjects were enrolled in this study. Plasma DA and urinary homovanilic acid (HVA) concentration were measured by ELISA, and the mRNA expression of dopa decarboxylase (DDC) in gastric mucosa was evaluated by RT-PCR in 30 patients with CEPS and 30 controls. Severity of epigastric pain before and after 12 weeks 2 x 50 mg itopride or sulpiride treatment was evaluated using the modified 10-point Visual Analogue Scale. Higher average levels of plasma DA and urinary HVA levels in CEPS patients than controls 129.5 ± 22.0 versus 109.1 ± 18.4 pg/ml (p < 0.001) and 6.82 ± 1.55 versus 5.39 ± 1.04 mg/24 h, respectively were obtained. Moreover, the expression of DDC in gastric mucosa of CEPS patients was higher than in healthy subjects (p < 0.01). Sulpiride subsided epigastric pain in 73.3%, but itopride reduced it only in 6.6% of CEPS patients. We concluded that altered dopamine signalling may affect locally-and-centrally mediated chronic epigastric pain.",2020,"Sulpiride subsided epigastric pain in 73.3%, but itopride reduced it only in 6.6% of CEPS patients.","['Chronic epigastric pain syndrome (CEPS', 'Sixty depressive patients with CEPS occurring independently of the diet and with no Helicobacter pylori infection and 30 healthy subjects', '30 patients with CEPS and 30 controls', 'patients without macroscopic and microscopic changes in gastric mucosa', 'chronic epigastric pain syndrome']",['dopamine (DA'],"['plasma DA and urinary HVA levels', 'expression of DDC in gastric mucosa', 'Sulpiride subsided epigastric pain', 'Severity of epigastric pain', 'mRNA expression of dopa decarboxylase (DDC) in gastric mucosa', 'modified 10-point Visual Analogue Scale', 'Plasma DA and urinary homovanilic acid (HVA) concentration']","[{'cui': 'C0743541', 'cui_str': 'Chronic epigastric pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017136', 'cui_str': 'Gastric mucous membrane structure'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C4042618', 'cui_str': 'DDC protein, human'}, {'cui': 'C0017136', 'cui_str': 'Gastric mucous membrane structure'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",60.0,0.0215326,"Sulpiride subsided epigastric pain in 73.3%, but itopride reduced it only in 6.6% of CEPS patients.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chojnacki', 'Affiliation': 'Department of Clinical Nutrition and Gastroenterological Diagnostics, Medical University, Lodz, Poland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Poplawski', 'Affiliation': 'Department of Molecular Genetics, Faculty of Biology and Environmental Sciences, University of Lodz, Lodz, Poland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Blasiak', 'Affiliation': 'Department of Molecular Genetics, Faculty of Biology and Environmental Sciences, University of Lodz, Lodz, Poland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fila', 'Affiliation': 'Department of Neurology, Polish Mother Memorial Hospital-Research Institute, Lodz, Poland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Konrad', 'Affiliation': 'Department of Clinical Nutrition and Gastroenterological Diagnostics, Medical University, Lodz, Poland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chojnacki', 'Affiliation': 'Department of Clinical Nutrition and Gastroenterological Diagnostics, Medical University, Lodz, Poland. jan.chojnacki@umed.lodz.pl.'}]",Journal of physiology and pharmacology : an official journal of the Polish Physiological Society,['10.26402/jpp.2020.6.05']
2667,33883615,Selection of aptamers against triple negative breast cancer cells using high throughput sequencing.,"Triple-negative breast cancer is the most aggressive subtype of invasive breast cancer with a poor prognosis and no approved targeted therapy. Hence, the identification of new and specific ligands is essential to develop novel targeted therapies. In this study, we aimed to identify new aptamers that bind to highly metastatic breast cancer MDA-MB-231 cells using the cell-SELEX technology aided by high throughput sequencing. After 8 cycles of selection, the aptamer pool was sequenced and the 25 most frequent sequences were aligned for homology within their variable core region, plotted according to their free energy and the key nucleotides possibly involved in the target binding site were analyzed. Two aptamer candidates, Apt1 and Apt2, binding specifically to the target cells with [Formula: see text] values of 44.3 ± 13.3 nM and 17.7 ± 2.7 nM, respectively, were further validated. The binding analysis clearly showed their specificity to MDA-MB-231 cells and suggested the targeting of cell surface receptors. Additionally, Apt2 revealed no toxicity in vitro and showed potential translational application due to its affinity to breast cancer tissue sections. Overall, the results suggest that Apt2 is a promising candidate to be used in triple-negative breast cancer treatment and/or diagnosis.",2021,"Two aptamer candidates, Apt1 and Apt2, binding specifically to the target cells with [Formula:","['44.3\u2009±\u200913.3\xa0nM and 17.7\u2009±\u20092.7\xa0nM, respectively, were further validated']",[],[],"[{'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C4517635', 'cui_str': '2.7'}]",[],[],,0.15997,"Two aptamer candidates, Apt1 and Apt2, binding specifically to the target cells with [Formula:","[{'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Ferreira', 'Affiliation': 'CEB - Centre of Biological Engineering, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Barbosa', 'Affiliation': 'CEB - Centre of Biological Engineering, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Sousa', 'Affiliation': 'CEB - Centre of Biological Engineering, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.'}, {'ForeName': 'Cátia', 'Initials': 'C', 'LastName': 'Silva', 'Affiliation': 'CEB - Centre of Biological Engineering, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.'}, {'ForeName': 'Luís D R', 'Initials': 'LDR', 'LastName': 'Melo', 'Affiliation': 'CEB - Centre of Biological Engineering, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Avci-Adali', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital Tuebingen, Calwerstr. 7/1, 72076, Tuebingen, Germany.'}, {'ForeName': 'Hans P', 'Initials': 'HP', 'LastName': 'Wendel', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital Tuebingen, Calwerstr. 7/1, 72076, Tuebingen, Germany.'}, {'ForeName': 'Ligia R', 'Initials': 'LR', 'LastName': 'Rodrigues', 'Affiliation': 'CEB - Centre of Biological Engineering, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal. lrmr@deb.uminho.pt.'}]",Scientific reports,['10.1038/s41598-021-87998-y']
2668,34757812,Quality of Life in Men With Prostate Cancer Randomly Allocated to Receive Docetaxel or Abiraterone in the STAMPEDE Trial.,"PURPOSE


Docetaxel and abiraterone acetate plus prednisone or prednisolone (AAP) both improve survival when commenced alongside standard of care (SOC) androgen deprivation therapy in locally advanced or metastatic hormone-sensitive prostate cancer. Thus, patient-reported quality of life (QOL) data may guide treatment choices.
METHODS


A group of patients within the STAMPEDE trial were contemporaneously enrolled with the possibility of being randomly allocated to receive either docetaxel + SOC or AAP + SOC. A mixed-model assessed QOL in those who had completed at least one QLQ-C30 + PR25 questionnaire. The primary outcome measure was difference in global-QOL (QLQ-C30 Q29&30) between patients allocated to docetaxel + SOC or AAP + SOC over the 2 years after random assignment, with a predefined criterion for clinically meaningful difference of > 4.0 points. Secondary outcome measures included longitudinal comparison of functional domains, pain, and fatigue, plus global-QOL at defined timepoints.
RESULTS


Five hundred fifteen patients (173 docetaxel + SOC and 342 AAP + SOC) were included. Baseline characteristics, proportion of missing data, and mean baseline global-QOL scores (docetaxel + SOC 77.8 and AAP + SOC 78.0) were similar. Over the 2 years following random assignment, the mean modeled global-QOL score was +3.9 points (95% CI, +0.5 to +7.2;  P  = .022) higher in patients allocated to AAP + SOC. Global-QOL was higher for patients allocated to AAP + SOC over the first year (+5.7 points, 95% CI, +3.0 to +8.5;  P  < .001), particularly at 12 (+7.0 points, 95% CI, +3.0 to +11.0;  P  = .001) and 24 weeks (+8.3 points, 95% CI, +4.0 to +12.6;  P  < .001).
CONCLUSION


Patient-reported QOL was superior for patients allocated to receive AAP + SOC, compared with docetaxel + SOC over a 2-year period, narrowly missing the predefined value for clinical significance. Patients receiving AAP + SOC reported clinically meaningful higher global-QOL scores throughout the first year following random assignment.",2021,"Global-QOL was higher for patients allocated to AAP + SOC over the first year (+5.7 points, 95% CI, +3.0 to +8.5;  P  < .001), particularly at 12 (+7.0 points, 95% CI, +3.0 to +11.0;  P  =","['A group of patients within the STAMPEDE trial were contemporaneously enrolled with the possibility', 'Men With Prostate Cancer', 'locally advanced or metastatic hormone-sensitive prostate cancer', 'Five hundred fifteen patients (173 docetaxel + SOC and 342 AAP + SOC) were included']","['care (SOC) androgen deprivation therapy', 'docetaxel + SOC', 'Docetaxel or Abiraterone', 'Docetaxel and abiraterone acetate plus prednisone or prednisolone (AAP', 'AAP + SOC', 'docetaxel + SOC or AAP + SOC']","['global-QOL (QLQ-C30 Q29&30', 'Baseline characteristics, proportion of missing data, and mean baseline global-QOL scores', 'Global-QOL', 'Quality of Life', 'longitudinal comparison of functional domains, pain, and fatigue, plus global-QOL at defined timepoints', 'global-QOL scores', 'mean modeled global-QOL score']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",515.0,0.158899,"Global-QOL was higher for patients allocated to AAP + SOC over the first year (+5.7 points, 95% CI, +3.0 to +8.5;  P  < .001), particularly at 12 (+7.0 points, 95% CI, +3.0 to +11.0;  P  =","[{'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Rush', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Murphy', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Alicia K', 'Initials': 'AK', 'LastName': 'Morgans', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'The Christie and Salford Royal NHS Foundation Trusts, Manchester, United Kingdom.'}, {'ForeName': 'Adrian D', 'Initials': 'AD', 'LastName': 'Cook', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'UCL Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Archie', 'Initials': 'A', 'LastName': 'Macnair', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': 'Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'J Martin', 'Initials': 'JM', 'LastName': 'Russell', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Gillessen', 'Affiliation': 'Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Matheson', 'Affiliation': 'University of Wolverhampton, Wolverhampton, United Kingdom.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Millman', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Brawley', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Pugh', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Jacob S', 'Initials': 'JS', 'LastName': 'Tanguay', 'Affiliation': 'Velindre Cancer Centre, Cardiff, Wales.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': 'Velindre Cancer Centre, Cardiff, Wales.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rudman', 'Affiliation': ""Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Joe M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': ""Patrick G. Johnston Centre for Cancer Research, Queen's University Belfast, United Kingdom.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Gale', 'Affiliation': 'Portsmouth Hospital University Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Rosemere Cancer Centre, Lancs Teaching Hospitals, Preston, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Protheroe', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Gray', 'Affiliation': 'Musgrove Park Hospital, Taunton, United Kingdom.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Perna', 'Affiliation': 'Royal Surrey Hospital Foundation Trust, Guildford, United Kingdom.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Tolan', 'Affiliation': 'The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'McPhail', 'Affiliation': 'Raigmore Hospital, Inverness, Scotland.'}, {'ForeName': 'Zaf I', 'Initials': 'ZI', 'LastName': 'Malik', 'Affiliation': 'The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Salil', 'Initials': 'S', 'LastName': 'Vengalil', 'Affiliation': 'University Hospital North Midlands NHS Trust, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fackrell', 'Affiliation': 'University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hoskin', 'Affiliation': 'University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Duncan C', 'Initials': 'DC', 'LastName': 'Gilbert', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.00728']
2669,34758080,"A Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of Amiselimod in Patients with Moderate to Severe Active Crohn's Disease.","BACKGROUND AND AIMS


Amiselimod is an oral selective S1P1 receptor modulator with potentially fewer adverse effects than fingolimod. We evaluated the safety, tolerability and clinical efficacy of amiselimod in participants with moderate to severe active Crohn's disease.
METHODS


Phase IIa, multicentre, randomised, double-blind, parallel group, placebo-controlled study comparing amiselimod 0.4 mg with placebo over a 14-week treatment period. The primary endpoint of the study was the proportion of participants with clinical response (CDAI 100) from baseline at Week 12.
RESULTS


180 patients were screened and 78 randomised (40 to amiselimod 0.4 mg and 38 to placebo). There was no significant difference in the proportion of patients achieving CDAI 100 at week 12 on amiselimod 0.4 mg and on placebo (48.7% vs. 54.1%, respectively) (OR [95% confidence interval]: 0.79 [0.31,1.98]). The results from the secondary endpoint analyses supported the results of the primary endpoint analysis. Treatment with amiselimod 0.4 mg was generally well-tolerated with 71.8% of participants completing the 14-week treatment period. Seven participants had serious adverse events and 4 discontinued treatment in the amiselimod group.
CONCLUSIONS


Amiselimod 0.4 mg for 12 weeks was not superior to placebo for the induction of clinical response (CDAI 100) in Crohn's disease. Treatment with amiselimod 0.4 mg was generally well tolerated and no new safety concerns related to amiselimod were reported in this study.",2021,"There was no significant difference in the proportion of patients achieving CDAI 100 at week 12 on amiselimod 0.4 mg and on placebo (48.7% vs. 54.1%, respectively) (OR [95% confidence interval]: 0.79 [0.31,1.98]).","['180 patients were screened and 78 randomised (40 to', ""Patients with Moderate to Severe Active Crohn's Disease"", ""participants with moderate to severe active Crohn's disease""]","['Placebo', 'amiselimod 0.4\xa0mg with placebo', 'amiselimod', 'amiselimod 0.4\xa0mg and 38 to placebo', 'Amiselimod', 'placebo']","['tolerated', 'serious adverse events', 'proportion of participants with clinical response (CDAI 100', 'Safety, Tolerability and Efficacy', 'proportion of patients achieving CDAI', 'safety, tolerability and clinical efficacy']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4548794', 'cui_str': 'amiselimod'}, {'cui': 'C4517457', 'cui_str': '0.4'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",180.0,0.577054,"There was no significant difference in the proportion of patients achieving CDAI 100 at week 12 on amiselimod 0.4 mg and on placebo (48.7% vs. 54.1%, respectively) (OR [95% confidence interval]: 0.79 [0.31,1.98]).","[{'ForeName': 'Geert', 'Initials': 'G', 'LastName': ""D'Haens"", 'Affiliation': 'Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'University Vita-Salute San Raffaele Milan, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Mitsubishi Tanabe Pharma Europe, London, United Kingdom.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Kitasato University Kitasato Institute Hospital, Tokyo, Japan.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjab201']
2670,34758073,The effect of low-dose aspirin on frailty phenotype and frailty index in community-dwelling older adults in the ASPirin in Reducing Events in the Elderly study.,"BACKGROUND


Frailty is associated with chronic inflammation, which may be modified by aspirin. The purpose of this study was to determine whether low dose aspirin reduces incident frailty in healthy older adult participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial.
METHODS


In the U.S and Australia, 19,114 community-dwelling individuals aged ≥70 years (U.S minorities ≥65 years) and free of overt cardiovascular disease, persistent physical disability, and dementia, were enrolled in ASPREE, a double-blind, placebo-controlled trial of 100mg daily aspirin versus placebo. Frailty, a pre-specified study endpoint, was defined according to a modified Fried frailty definition (Fried frailty) and the frailty index based on the deficit accumulation model (frailty index). Competing risk Cox proportional hazards models were used to compare time to incident frailty by aspirin versus placebo. Sensitivity analysis was conducted to include frailty data with and without imputation of missing data.
RESULTS


Over a median 4.7 years, 2252 participants developed incident Fried frailty, and 4451 had incident frailty according to the frailty index. Compared with placebo, aspirin treatment did not alter the risk of incident frailty (Fried frailty HR: 1.04, 95% CI 0.96-1.13; frailty index HR: 1.03, 95% CI 0.97-1.09). The proportion of individuals classified as frail, and the trajectory in continuous frailty scores over time, were not different between the aspirin and placebo treatment groups. The results were consistent across a series of subgroups.
CONCLUSIONS


Low dose aspirin use in healthy older adults when initiated in older ages does not reduce risk of incident frailty or the trajectory of frailty.",2021,"Compared with placebo, aspirin treatment did not alter the risk of incident frailty (Fried frailty HR: 1.04, 95% CI 0.96-1.13; frailty index HR: 1.03, 95% CI 0.97-1.09).","['healthy older adult participants of the', '2252 participants developed incident Fried frailty, and 4451 had incident frailty according to the frailty index', '19,114 community-dwelling individuals aged ≥70 years (U.S minorities ≥65 years) and free of overt cardiovascular disease, persistent physical disability, and dementia', 'community-dwelling older adults', 'healthy older adults']","['low-dose aspirin', 'aspirin versus placebo', 'aspirin and placebo', 'ASPirin', 'placebo', 'aspirin', 'placebo, aspirin']","['risk of incident frailty', 'frailty phenotype and frailty index']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}]",19114.0,0.271975,"Compared with placebo, aspirin treatment did not alter the risk of incident frailty (Fried frailty HR: 1.04, 95% CI 0.96-1.13; frailty index HR: 1.03, 95% CI 0.97-1.09).","[{'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Espinoza', 'Affiliation': 'Division of Geriatrics, Gerontology & Palliative Medicine, Sam and Ann Barshop Institute for Longevity and Aging Studies, UT Health San Antonio, San Antonio, Texas and Geriatrics Research, Education and Clinical Center, South Texas Veterans Health Care System, San Antonio, Texas, US.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': 'A R M Saifuddin', 'Initials': 'ARMS', 'LastName': 'Ekram', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City, US.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois, US.""}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Ward', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': 'Van Cleef/Roet Centre for Nervous Diseases, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Research Institute, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Trevaks', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': 'Sharyn M', 'Initials': 'SM', 'LastName': 'Fitzgerald', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': 'Nigel P', 'Initials': 'NP', 'LastName': 'Stocks', 'Affiliation': 'University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Clinical Outcomes and Research, Hennepin Health Research Institute and Division of Geriatrics, Department of Medicine, Hennepin Healthcare and University of Minnesota, Minneapolis, US.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Center for Aging and Population Health, University of Pittsburgh, Pennsylvania, US.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab340']
2671,34758069,"The CLL12 trial: Ibrutinib versus placebo in treatment-naïve, early stage chronic lymphocytic leukemia.","Observation is the current standard of care for patients with early stage asymptomatic chronic lymphocytic leukemia (CLL), as chemotherapy-based interventions have failed to prolong survival. We hypothesized that early intervention with ibrutinib would be well tolerated and lead to superior disease control in a subgroup of early stage patients with CLL. The phase 3, double-blind, placebo-controlled CLL12 trial randomly assigned asymptomatic, treatment-naïve Binet stage A CLL patients at increased risk of progression in a 1:1 ratio to receive ibrutinib (N=182) or placebo (N=181) at a dose of 420 mg daily. At a median follow up of 31 months the study met its primary endpoint by significantly improving event-free survival in the ibrutinib group (median, not reached vs. 47.8 months; hazard ratio=0.25; 95% confidence interval=0.14-0.43, P<0.0001). Compared to placebo, ibrutinib did not increase overall toxicity, yielding similar incidence and severity of adverse events. The most common serious adverse events were atrial fibrillation, pneumonia and rash in the ibrutinib group, and basal cell carcinoma, pneumonia and myocardial infarction in the placebo group. Ibrutinib-associated risk for bleeding (33.5%) was decreased by prohibiting use of oral anticoagulants through an amendment of the study protocol and by avoiding CYP3A4 drug-drug interactions. Taken together, ibrutinib confirms efficacy in CLL patients at early stage with increased risk of progression. However, the results do not justify to change the current standard of 'watch and wait'. The trial is registered at clinicaltrials.gov as NCT02863718.",2021,"At a median follow up of 31 months the study met its primary endpoint by significantly improving event-free survival in the ibrutinib group (median, not reached vs. 47.8 months; hazard ratio=0.25; 95% confidence interval=0.14-0.43, P<0.0001).","['patients with early stage asymptomatic chronic lymphocytic leukemia (CLL', 'treatment-naïve, early stage chronic lymphocytic leukemia']",['placebo'],"['Ibrutinib-associated risk for bleeding', 'overall toxicity, yielding similar incidence and severity of adverse events', 'basal cell carcinoma, pneumonia and myocardial infarction', 'improving event-free survival', 'atrial fibrillation, pneumonia and rash']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",,0.563897,"At a median follow up of 31 months the study met its primary endpoint by significantly improving event-free survival in the ibrutinib group (median, not reached vs. 47.8 months; hazard ratio=0.25; 95% confidence interval=0.14-0.43, P<0.0001).","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Langerbeins', 'Affiliation': 'University Hospital, Cologne, Germany.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'University Hospital of Cologne, Köln, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'University Hospital of Cologne, Köln, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cramer', 'Affiliation': 'Department I of Internal Medicine and German CLL Study Group; Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD); University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Fürstenau', 'Affiliation': 'University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Othman', 'Initials': 'O', 'LastName': 'Al-Sawaf', 'Affiliation': 'University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'von Tresckow', 'Affiliation': 'University Hospital of Cologne, Germany.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Karl-Anton', 'Initials': 'KA', 'LastName': 'Kreuzer', 'Affiliation': 'University at Cologne, Cologne, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Vehling-Kaiser', 'Affiliation': 'Outpatient Clinic, Landshut, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Ulm University, Ulm, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Müller', 'Affiliation': 'Studienzentrum UnterEms, Leer, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Eckart', 'Affiliation': 'Onkologische Schwerpunktpraxis Erlangen, Erlangen, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Schlag', 'Affiliation': 'Practice for Hematology and Oncology, Würzburg, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Freier', 'Affiliation': 'Medicinum, Hildesheim, Alabama, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Gaska', 'Affiliation': 'Brüderkrankenhaus St. Josef, Paderborn, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Balser', 'Affiliation': 'Practice for Internal Medicine, Marburg, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Reiser', 'Affiliation': 'PIOH, Cologne, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Stauch', 'Affiliation': 'Practice for Internal Medicine, Kronach, Germany.'}, {'ForeName': 'Clemens-Martin', 'Initials': 'CM', 'LastName': 'Wendtner', 'Affiliation': 'Munich Clinic Schwabing, Academic Teaching Hospital, Ludwig-Maximilians University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Saarland University Medical School, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'University of Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'University Hospital, Cologne, Germany.'}]",Blood,['10.1182/blood.2021010845']
2672,34758065,Frailty and Depression in Late Life: A High-Risk Comorbidity with Distinctive Clinical Presentation and Poor Antidepressant Response.,"BACKGROUND


Investigate the longitudinal relationship between physical frailty, the clinical representation of accelerated biological aging, and antidepressant medication response in older adults with depressive illness.
METHODS


An 8-week randomized placebo-controlled trial (escitalopram or duloxetine) followed by 10-months of open antidepressant medication treatment (augmentation, switch strategies) was conducted in an outpatient research clinic. 121 adults age > 60 years with Major Depressive (MDD) or Persistent Depressive Disorders and a 24-item Hamilton Rating Scale for Depression (HRSD) > 16 were enrolled. Primary measures assessed serially over 12-months include response (50% reduction from baseline HRSD score), remission (HRSD score < 10), and frailty (non/intermediate frail [0-2 deficits] vs frail [> 3 deficits]); latent class analysis was used to classify longitudinal frailty trajectories.
RESULTS


A 2-class model best fit the data, identifying a consistently-low frailty-risk (63% of the sample) and consistently-high frailty-risk (37% of the sample) trajectory. Response and remission rates (P's<.002) for adults in the high-risk frailty class were at least 21 percentage-points worse than those in the low-risk class over 12-months. Furthermore, subsequent frailty was associated with previous frailty (P's < .01) but not previous response or remission (P's > .10).
CONCLUSIONS


Antidepressant medication is poorly effective for MDD occurring in the context of frailty in older adults. Furthermore, even when an antidepressant response is achieved, this response does little to improve their frailty. These data suggest that standard psychiatric assessment of depressed older adults should include frailty measures and that novel therapeutic strategies to address comorbid frailty and depression are needed.",2021,Response and remission rates (P's<.002) for adults in the high-risk frailty class were at least 21 percentage-points worse than those in the low-risk class over 12-months.,"['depressed older adults', 'older adults', ' 16 were enrolled', 'older adults with depressive illness', 'Late Life', '121 adults age > 60 years with Major Depressive (MDD) or Persistent Depressive Disorders and a']","['placebo-controlled trial (escitalopram or duloxetine', 'open antidepressant medication treatment (augmentation, switch strategies']","['Response and remission rates', 'baseline HRSD score), remission (HRSD score < 10), and frailty (non/intermediate frail [0-2 deficits', '24-item Hamilton Rating Scale for Depression (HRSD']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",121.0,0.0548419,Response and remission rates (P's<.002) for adults in the high-risk frailty class were at least 21 percentage-points worse than those in the low-risk class over 12-months.,"[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Brown', 'Affiliation': 'New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons, New York, NY USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Ciarleglio', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington DC.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Roose', 'Affiliation': 'New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons, New York, NY USA.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Montes Garcia', 'Affiliation': 'New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons, New York, NY USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': 'Albert Einstein College of Medicine, New York, NY USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fernandes', 'Affiliation': 'New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons, New York, NY USA.'}, {'ForeName': 'Bret R', 'Initials': 'BR', 'LastName': 'Rutherford', 'Affiliation': 'New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons, New York, NY USA.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab338']
2673,34758057,Carbon Dioxide Changes during High-flow Nasal Oxygenation in Apneic Patients: A Single-center Randomized Controlled Noninferiority Trial.,"BACKGROUND


Anesthesia studies using high-flow, humidified, heated oxygen delivered via nasal cannulas at flow rates of more than 50 l · min-1 postulated a ventilatory effect because carbon dioxide increased at lower levels as reported earlier. This study investigated the increase of arterial partial pressure of carbon dioxide between different flow rates of 100% oxygen in elective anesthetized and paralyzed surgical adults before intubation.
METHODS


After preoxygenation and standardized anesthesia induction with nondepolarizing neuromuscular blockade, all patients received 100% oxygen (via high-flow nasal oxygenation system or circuit of the anesthesia machine), and continuous jaw thrust/laryngoscopy was applied throughout the 15-min period. In this single-center noninferiority trial, 25 patients each, were randomized to five groups: (1) minimal flow: 0.25 l · min-1, endotracheal tube; (2) low flow: 2 l · min-1, continuous jaw thrust; (3) medium flow: 10 l · min-1, continuous jaw thrust; (4) high flow: 70 l · min-1, continuous jaw thrust; and (5) control: 70 l · min-1, continuous laryngoscopy. Immediately after anesthesia induction, the 15-min apnea period started with oxygen delivered according to the randomized flow rate. Serial arterial blood gas analyses were drawn every 2 min. The study was terminated if either oxygen saturation measured by pulse oximetry was less than 92%, transcutaneous carbon dioxide was greater than 100 mmHg, pH was less than 7.1, potassium level was greater than 6 mmol · l-1, or apnea time was 15 min. The primary outcome was the linear rate of mean increase of arterial carbon dioxide during the 15-min apnea period computed from linear regressions.
RESULTS


In total, 125 patients completed the study. Noninferiority with a predefined noninferiority margin of 0.3 mmHg · min-1 could be declared for all treatments with the following mean and 95% CI for the mean differences in the linear rate of arterial partial pressure of carbon dioxide with associated P values regarding noninferiority: high flow versus control, -0.0 mmHg · min-1 (-0.3, 0.3 mmHg · min-1, P = 0.030); medium flow versus control, -0.1 mmHg · min-1 (-0.4, 0.2 mmHg · min-1, P = 0.002); low flow versus control, -0.1 mmHg · min-1 (-0.4, 0.2 mmHg · min-1, P = 0.003); and minimal flow versus control, -0.1 mmHg · min-1 (-0.4, 0.2 mmHg · min-1, P = 0.004).
CONCLUSIONS


Widely differing flow rates of humidified 100% oxygen during apnea resulted in comparable increases of arterial partial pressure of carbon dioxide, which does not support an additional ventilatory effect of high-flow nasal oxygenation.
EDITOR’S PERSPECTIVE


",2021,"mmHg · min-1 (-0.4, 0.2 mmHg · min-1, P = 0.004).
","['elective anesthetized and paralyzed surgical adults before intubation', '25 patients each', 'Apneic Patients', '125 patients completed the study']","['minimal flow: 0.25 l · min-1, endotracheal tube; (2) low flow: 2 l · min-1, continuous jaw thrust; (3) medium flow: 10 l · min-1, continuous jaw thrust; (4) high flow: 70 l · min-1, continuous jaw thrust; and (5) control: 70 l · min-1, continuous laryngoscopy', '100% oxygen (via high-flow nasal oxygenation system or circuit of the anesthesia machine), and continuous jaw thrust/laryngoscopy']","['oxygen saturation measured by pulse oximetry', 'linear rate of mean increase of arterial carbon dioxide', 'transcutaneous carbon dioxide', 'arterial partial pressure of carbon dioxide', 'apnea time', 'Carbon Dioxide Changes', 'linear rate of arterial partial pressure of carbon dioxide', 'potassium level']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0396612', 'cui_str': 'Jaw thrust'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0179064', 'cui_str': 'Anesthesia machine'}]","[{'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}]",125.0,0.0786983,"mmHg · min-1 (-0.4, 0.2 mmHg · min-1, P = 0.004).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Riva', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Greif', 'Affiliation': ''}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Kaiser', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Riedel', 'Affiliation': ''}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Huber', 'Affiliation': ''}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Theiler', 'Affiliation': ''}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Nabecker', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000004025']
2674,34758056,"Hyaluronic Acid Compound Filling plus Mesotherapy Versus Botulinum Toxin A for the Treatment of Horizontal Neck Lines: A Multicenter, Randomized, Evaluator-Blinded, Prospective Study in Chinese Subjects.","BACKGROUND


Although energy devices and botulinum toxin-A (BTX-A) could alleviate the age-related laxity, ptosis, and platysmal bands, they have limited efficacy on horizontal neck lines.
OBJECTIVES


The purpose of this study was to investigate the efficacy, safety, and subject satisfaction of non-cross-linked hyaluronic acid (HA) compound filling plus mesotherapy combined treatment for the correction of horizontal neck lines, in comparison with BTX-A.
METHODS


This multi-center, randomized, evaluator-blinded, prospective study enrolled female patients with moderate-to-severe horizontal neck lines corrected with either 2-3 sessions of non-cross-linked HA compound filling plus mesotherapy combined treatment or one session of BTX-A injection. Improvement of the neck lines grades, global aesthetic improvement scale (GAIS), patient satisfaction, and adverse events (AEs) were evaluated and compared on 1, 3, 6, and 10 months after the final treatment.
RESULTS


Twenty-five patients received HA filling plus mesotherapy combined treatment and 23 received BTX-A injection. Compared with BTX-A, the HA compound filling plus mesotherapy combined treatment significantly improved the horizontal neck lines grades on all follow-up visits (P=0.000). Cases of different baseline grades (2, 2.5, and 3) demonstrated similar outcomes. The GAIS and patients' satisfaction ratings were significantly higher for the HA combined treatment group (P=0.000). Significantly higher pain ratings, higher incidence, and longer recovery of AEs (erythema, edema, and ecchymosis) were noticed in the combined treatment group (P<0.001). No serious AEs occurred.
CONCLUSIONS


Compared with BTX-A, the HA compound filling plus mesotherapy combined treatment significantly improved moderate-to-severe horizontal neck lines and achieved a high level of patients' satisfaction.",2021,The GAIS and patients' satisfaction ratings were significantly higher for the HA combined treatment group (P=0.000).,"['enrolled female patients with moderate-to-severe horizontal neck lines corrected with either 2-3 sessions of non-cross-linked HA compound filling plus mesotherapy combined treatment or one session of BTX-A injection', 'Horizontal Neck Lines', 'Chinese Subjects']","['botulinum toxin-A (BTX-A', 'non-cross-linked hyaluronic acid (HA) compound filling plus mesotherapy combined treatment', 'Hyaluronic Acid Compound Filling plus Mesotherapy Versus Botulinum Toxin A', 'BTX-A injection']","['efficacy, safety, and subject satisfaction', 'pain ratings, higher incidence, and longer recovery of AEs (erythema, edema, and ecchymosis', 'horizontal neck lines grades', 'moderate-to-severe horizontal neck lines', 'neck lines grades, global aesthetic improvement scale (GAIS), patient satisfaction, and adverse events (AEs', ""GAIS and patients' satisfaction ratings""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2242515', 'cui_str': 'Mesotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2242515', 'cui_str': 'Mesotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",25.0,0.0405845,The GAIS and patients' satisfaction ratings were significantly higher for the HA combined treatment group (P=0.000).,"[{'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology Department of Dermatology and Venerology, Chengdu, Sichuan, China.'}, {'ForeName': 'Meirong', 'Initials': 'M', 'LastName': 'Liao', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yijin', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Dermatology, Xian FreSkin hospital, Xian, Shanxi, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Dermatology, Xian FreSkin hospital, Xian, Shanxi, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Dermatology, Changsha FreSkin hospital, Changsha, Hunan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Dermatology, Chongqing FreSkin hospital, Chongqing, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Plastic Surgery, Sichuan FreSkin hospital, Chengdu, Sichuan, China.'}]",Aesthetic surgery journal,['10.1093/asj/sjab387']
2675,34758017,Community control strategies for scabies: A cluster randomised noninferiority trial.,"BACKGROUND


Scabies is a neglected tropical disease hyperendemic to many low- and middle-income countries. Scabies can be successfully controlled using mass drug administration (MDA) using 2 doses of ivermectin-based treatment. If effective, a strategy of 1-dose ivermectin-based MDA would have substantial advantages for implementing MDA for scabies at large scale.
METHODS AND FINDINGS


We did a cluster randomised, noninferiority, open-label, 3-group unblinded study comparing the effectiveness of control strategies on community prevalence of scabies at 12 months. All residents from 35 villages on 2 Fijian islands were eligible to participate. Villages were randomised 1:1:1 to 2-dose ivermectin-based MDA (IVM-2), 1-dose ivermectin-based MDA (IVM-1), or screen and treat with topical permethrin 5% for individuals with scabies and their household contacts (SAT). All groups also received diethylcarbamazine and albendazole for lymphatic filariasis control. For IVM-2 and IVM-1, oral ivermectin was dosed at 200 μg/kg and when contraindicated substituted with permethrin. We designated a noninferiority margin of 5%. We enrolled 3,812 participants at baseline (July to November 2017) from the 35 villages with median village size of 108 (range 18 to 298). Age and sex of participants were representative of the population with 51.6% male and median age of 25 years (interquartile range 10 to 47). We enrolled 3,898 at 12 months (July to November 2018). At baseline, scabies prevalence was similar in all groups: IVM-2: 11.7% (95% confidence interval (CI) 8.5 to 16.0); IVM-1: 15.2% (95% CI 9.4 to 23.8); SAT: 13.6% (95% CI 7.9 to 22.4). At 12 months, scabies decreased substantially in all groups: IVM-2: 1.3% (95% CI 0.6 to 2.5); IVM-1: 2.7% (95% CI 1.1 to 6.5); SAT: 1.1% (95% CI 0.6 to 2.0). The risk difference in scabies prevalence at 12 months between the IVM-1 and IVM-2 groups was 1.2% (95% CI -0.2 to 2.7, p = 0.10). Limitations of the study included the method of scabies diagnosis by nonexperts, a lower baseline prevalence than anticipated, and the addition of diethylcarbamazine and albendazole to scabies treatment.
CONCLUSIONS


All 3 strategies substantially reduced prevalence. One-dose was noninferior to 2-dose ivermectin-based MDA, as was a screen and treat approach, for community control of scabies. Further trials comparing these approaches in varied settings are warranted to inform global scabies control strategies.
TRIAL REGISTRATION


Clinitrials.gov NCT03177993 and ANZCTR N12617000738325.",2021,"The risk difference in scabies prevalence at 12 months between the IVM-1 and IVM-2 groups was 1.2% (95% CI -0.2 to 2.7, p = 0.10).","['All residents from 35 villages on 2 Fijian islands were eligible to participate', 'scabies', 'Age and sex of participants were representative of the population with 51.6% male and median age of 25 years (interquartile range 10 to 47', '3,812 participants at baseline (July to November 2017) from the 35 villages with median village size of 108 (range 18 to 298', 'We enrolled 3,898 at 12 months (July to November 2018', 'community prevalence of scabies at 12 months']","['ivermectin', 'IVM-2', 'diethylcarbamazine and albendazole', 'ivermectin-based MDA (IVM-2), 1-dose ivermectin-based MDA (IVM-1), or screen and treat with topical permethrin 5% for individuals with scabies and their household contacts (SAT', 'ivermectin-based MDA', 'IVM-1']",['scabies prevalence'],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0574392', 'cui_str': 'Fijian language'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0596795', 'cui_str': 'In Vivo Microscopy'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3219686', 'cui_str': 'Permethrin-containing product in cutaneous dose form'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",3812.0,0.528032,"The risk difference in scabies prevalence at 12 months between the IVM-1 and IVM-2 groups was 1.2% (95% CI -0.2 to 2.7, p = 0.10).","[{'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Hardy', 'Affiliation': ""Tropical Diseases, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Josaia', 'Initials': 'J', 'LastName': 'Samuela', 'Affiliation': 'Fiji Ministry of Health and Medical Services, Suva, Fiji.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Kama', 'Affiliation': 'Fiji Ministry of Health and Medical Services, Suva, Fiji.'}, {'ForeName': 'Meciusela', 'Initials': 'M', 'LastName': 'Tuicakau', 'Affiliation': 'Fiji Ministry of Health and Medical Services, Suva, Fiji.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Romani', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Margot J', 'Initials': 'MJ', 'LastName': 'Whitfeld', 'Affiliation': ""St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'King', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University and Veterans Affairs Medical Center, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Weil', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Schuster', 'Affiliation': 'Department of Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Anneke C', 'Initials': 'AC', 'LastName': 'Grobler', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Engelman', 'Affiliation': ""Tropical Diseases, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Leanne J', 'Initials': 'LJ', 'LastName': 'Robinson', 'Affiliation': 'Vector-borne Diseases and Tropical Public Health, Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kaldor', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Steer', 'Affiliation': ""Tropical Diseases, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}]",PLoS medicine,['10.1371/journal.pmed.1003849']
2676,34757989,"A Peer-Led, Artificial Intelligence-Augmented Social Network Intervention to Prevent HIV Among Youth Experiencing Homelessness.","BACKGROUND


Youth experiencing homelessness (YEH) are at elevated risk of HIV/AIDS and disproportionately identify as racial, ethnic, sexual, and gender minorities. We developed a new peer change agent (PCA) HIV prevention intervention with 3 arms: (1) an arm using an artificial intelligence (AI) planning algorithm to select PCAs; (2) a popularity arm, the standard PCA approach, operationalized as highest degree centrality (DC); and (3) an observation-only comparison group.
SETTING


A total of 713 YEH were recruited from 3 drop-in centers in Los Angeles, CA.
METHODS


Youth consented and completed a baseline survey that collected self-reported data on HIV knowledge, condom use, and social network information. A quasi-experimental pretest/posttest design was used; 472 youth (66.5% retention at 1 month postbaseline) and 415 youth (58.5% retention at 3 months postbaseline) completed follow-up. In each intervention arm (AI and DC), 20% of youth was selected as PCAs and attended a 4-hour initial training, followed by 7 weeks of half-hour follow-up sessions. Youth disseminated messages promoting HIV knowledge and condom use.
RESULTS


Using generalized estimating equation models, there was a significant reduction over time (P < 0.001) and a significant time by AI arm interaction (P < 0.001) for condomless anal sex act. There was a significant increase in HIV knowledge over time among PCAs in DC and AI arms.
CONCLUSIONS


PCA models that promote HIV knowledge and condom use are efficacious for YEH. Youth are able to serve as a bridge between interventionists and their community. Interventionists should consider working with computer scientists to solve implementation problems.",2021,"Using generalized estimating equation models, there was a significant reduction over time (P < 0.001) and a significant time by AI arm interaction (P < 0.001) for condomless anal sex act.","['Youth consented and completed a baseline survey that collected self-reported data on HIV knowledge, condom use, and social network information', 'Youth Experiencing Homelessness', '472 youth (66.5% retention at 1 month postbaseline) and 415 youth (58.5% retention at 3 months postbaseline) completed follow-up', 'A total of 713 YEH were recruited from 3 drop-in centers in Los Angeles, CA', 'Youth experiencing homelessness (YEH']","['Artificial Intelligence-Augmented Social Network Intervention to Prevent HIV', 'new peer change agent (PCA) HIV prevention intervention with 3 arms: (1) an arm using an artificial intelligence (AI) planning algorithm to select PCAs']",['HIV knowledge'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",713.0,0.0221156,"Using generalized estimating equation models, there was a significant reduction over time (P < 0.001) and a significant time by AI arm interaction (P < 0.001) for condomless anal sex act.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rice', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work and Center for Artificial Intelligence in Society, University of Southern California Los Angeles, CA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Wilder', 'Affiliation': 'Center for Research on Computation and Society, John A. Paulson School of Engineering and Applied Sciences, Harvard University Cambridge, MA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Onasch-Vera', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work and Center for Artificial Intelligence in Society, University of Southern California Los Angeles, CA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'DiGuiseppi', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work and Center for Artificial Intelligence in Society, University of Southern California Los Angeles, CA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Petering', 'Affiliation': 'Lens Co.'}, {'ForeName': 'Chyna', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work and Center for Artificial Intelligence in Society, University of Southern California Los Angeles, CA.'}, {'ForeName': 'Amulya', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': 'College of Information Sciences and Technology, Pennsylvania State University College Station, TX; and.'}, {'ForeName': 'Sung-Jae', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Division of Population Behavioral Health, David Geffen School of Medicine, University of California, Los Angeles Los Angeles, CA.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Tambe', 'Affiliation': 'Center for Research on Computation and Society, John A. Paulson School of Engineering and Applied Sciences, Harvard University Cambridge, MA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002807']
2677,34757964,Pharmacological Management of Myasthenia Gravis: A Century of Expert Opinions in Cecil Textbook of Medicine.,"BACKGROUND


Advances in drug therapy for myasthenia gravis have had a significant impact on the quality of life and work potential of a substantial majority of affected persons and has contributed to a remarkable decrease in the frequency and severity of complications, hospitalizations, and mortality.
STUDY QUESTION


What are the milestones of the changes in the expert approach to the pharmacological management of myasthenia in the past century?
STUDY DESIGN


To determine the changes in the experts' approach to the management of myasthenia gravis, as presented in a widely used textbook in the United States.
DATA SOURCES


The chapters presenting the management of myasthenia gravis in the 26 editions of Cecil Textbook of Medicine published from 1927 to 2020.
RESULTS


Adequate feeding, absolute rest in bed, and ""tonics"" were the only interventions recommended for the care of patients with myasthenia gravis in 1927. Ephedrine and glycine were used in the early 1930s. Treatment with the anticholinesterases physostigmine and neostigmine was recommended in 1937, 3 years after Mary Walker discovered it in the United Kingdom. Immunosuppressant pharmacological interventions with prednisone and azathioprine have been considered the standard since 1975, and intravenous immune globulin was added to usual care in 1996. The newer immunosuppressant drugs mycophenolate, cyclosporine, and tacrolimus have expanded the arsenal since 2008, and the monoclonal antibodies rituximab and eculizumab have been mentioned in the textbooks published in 2012-2020. The first randomized clinical trial of drug therapy for myasthenia gravis was published in 1987.
CONCLUSIONS


The pharmacological management of myasthenia gravis was revolutionized by the epiphany of an astute clinician in the 1930s. Immunosuppressant treatment was a logical step once the autoimmune nature of the condition was established. The major therapeutic advances highlight the values of empiricism and persistent attention to detail in treating relatively rare chronic disorders.",2021,"What are the milestones of the changes in the expert approach to the pharmacological management of myasthenia in the past century?
","['myasthenia gravis in the 26 editions of Cecil Textbook of Medicine published from 1927 to 2020', 'myasthenia gravis was published in 1987', 'myasthenia gravis', 'patients with myasthenia gravis in 1927', 'Myasthenia Gravis']","['Ephedrine and glycine', 'Immunosuppressant', 'prednisone and azathioprine', 'anticholinesterases physostigmine and neostigmine', 'mycophenolate, cyclosporine, and tacrolimus']",[],"[{'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0456591', 'cui_str': '1987'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0008425', 'cui_str': 'Cholinesterase inhibitor'}, {'cui': 'C0031849', 'cui_str': 'Physostigmine'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]",[],,0.0146561,"What are the milestones of the changes in the expert approach to the pharmacological management of myasthenia in the past century?
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Manu', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY.'}, {'ForeName': 'Liliana M', 'Initials': 'LM', 'LastName': 'Rogozea', 'Affiliation': 'Basic, Preventive and Clinical Sciences Department, Transilvania University, Brasov, Romania; and.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Roman-Filip', 'Affiliation': 'Department of Neurology, University Lucian Blaga, Sibiu, Romania.'}]",American journal of therapeutics,['10.1097/MJT.0000000000001454']
2678,34757917,"Coronary vasomotion after treatment with drug-coated balloons or drug-eluting stents: a prospective, open-label, single-centre randomised trial.","BACKGROUND


Although recent studies have reported that drug-coated balloons (DCB) are non-inferior to drug-eluting stents (DES) for the treatment of native coronary arteries in a specific population, there is no available information concerning vasomotion after treatment with DCB.
AIMS


The aim of this study was to prospectively compare coronary vasomotion in patients with small coronary artery disease treated with DCB versus DES.
METHODS


Forty-two native lesions (2.0-3.0 mm) treated in our institution were randomly assigned to the DCB arm (n=19) or the bioabsorbable polymer everolimus-eluting stents arm (n=23) after successful predilation. At eight months after treatment, endothelium-dependent and -independent vasomotion was evaluated with intracoronary infusions in incremental doses of acetylcholine (right coronary artery: low dose 5 μg, high dose 50 μg; left coronary artery: low dose 10 μg, high dose 100 μg) and nitroglycerine (200 μg). The mean lumen diameter of the distal segment, beginning 5 mm and ending 15 mm distal to the edge of the treated segment, was quantitatively measured by angiography.
RESULTS


The luminal dimension in the treated segment did not differ between groups at the follow-up angiography. The vasoconstriction after acetylcholine infusion was less pronounced in the DCB arm than in the DES arm (low-dose: 6±13% vs -3±18%, p=0.060; high-dose: -4±17% vs -21±29%, p=0.035). The response to nitroglycerine did not differ between groups (17±13% vs 17±22%, p=0.929).
CONCLUSIONS


Vasoconstriction after acetylcholine infusion in the peri-treated region was less pronounced in the DCB arm than in the DES arm, suggesting that endothelial function in treated coronary vessels could be better preserved by DCB than by new-generation DES.",2021,"The response to nitroglycerine did not differ between groups (17±13% vs 17±22%, p=0.929).
","['patients with small coronary artery disease treated with DCB versus DES', 'Forty-two native lesions (2.0-3.0 mm) treated in our institution']","['Coronary vasomotion after treatment with drug-coated balloons or drug-eluting stents', 'bioabsorbable polymer everolimus-eluting stents', 'acetylcholine (right coronary artery: low dose 5 μg, high dose 50 μg; left coronary artery: low dose 10 μg, high dose 100 μg) and nitroglycerine', 'DCB']","['response to nitroglycerine', 'mean lumen diameter of the distal segment', 'luminal dimension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1261082', 'cui_str': 'Left coronary artery structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}]","[{'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0125971,"The response to nitroglycerine did not differ between groups (17±13% vs 17±22%, p=0.929).
","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Kawai', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': ''}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': ''}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': ''}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': ''}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Tamaki', 'Affiliation': ''}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kawasaki', 'Affiliation': ''}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kikuchi', 'Affiliation': ''}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': ''}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Tachibana', 'Affiliation': ''}, {'ForeName': 'Hirota', 'Initials': 'H', 'LastName': 'Kida', 'Affiliation': ''}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Sotomi', 'Affiliation': ''}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': ''}, {'ForeName': 'Masatake', 'Initials': 'M', 'LastName': 'Fukunami', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-21-00636']
2679,34757864,Bioenergetics of Islet Preparations in a Pilot Clinical Trial of Peri-Transplant Hydroxychloroquine for Autologous Islet Transplantation.,"The inflammatory response is an obstacle to success in both allogeneic and autologous islet transplantation. In autologous islet transplantation (AIT), however, the recipient is also the donor, permitting pretreatment of donor/recipient for a controlled duration prior to transplantation. We sought to exploit this feature of (AIT) by pretreating donor/recipients with chronic pancreatitis undergoing total pancreatectomy and autologous islet transplantation (TPAIT) to test the hypothesis that peri-transplant treatment with the FDA-approved anti-inflammatory hydroxychloroquine (HCQ) improves graft function. In this randomized placebo-controlled pilot clinical study, patients ( n  = 6) were treated with oral HCQ for 30 days prior to and 90 days after TPAIT. In vivo islet function was assessed via Mixed Meal Tolerance Testing before HCQ treatment, 6- and 12-months after surgery. In vitro islet bioenergetics were assessed at the time of transplantation via extracellular flux analysis of islet preparation samples from the clinical trial cohort and six additional patients ( n  = 12). Our study shows that HCQ did not alter clinical endpoints, but HCQ-treated patients showed greater spare respiratory capacity (SRC) compared to samples from control patients ( P =0.028). Glycolytic metabolism of islet preparations directly correlated with stimulated C-peptide secretion both before and after TPAIT ( P =0.01,  R   2 =0.489 and  P =0.03,  R   2 =0.674, respectively), and predicted in vivo islet function better than mitochondrial metabolism of islet preps or islet equivalents infused. Overnight culture of islet preparations altered bioenergetic function, significantly decreasing SRC and maximal respiration ( P <0.001). In conclusion, while HCQ did not alter clinical outcomes, it was associated with significantly increased SRC in islet preparations. Bioenergetic analyses of islet preparations suggests that culture should be avoided and that glycolysis may be a more sensitive indicator of in vivo islet function than current metrics, including islet oxygen consumption and islet equivalents infused.",2021,"Overnight culture of islet preparations altered bioenergetic function, significantly decreasing SRC and maximal respiration ( P <0.001).","['recipients with chronic pancreatitis undergoing', 'Autologous Islet Transplantation', 'patients ( n  = 6']","['autologous islet transplantation (AIT', 'HCQ', 'FDA-approved anti-inflammatory hydroxychloroquine (HCQ', 'oral HCQ', 'total pancreatectomy and autologous islet transplantation (TPAIT', 'placebo', 'Peri-Transplant Hydroxychloroquine']","['SRC and maximal respiration', 'bioenergetic function', 'SRC', 'Glycolytic metabolism', 'spare respiratory capacity (SRC']","[{'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0079646', 'cui_str': 'Islet cell transplant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0079646', 'cui_str': 'Islet cell transplant'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040511', 'cui_str': 'Total pancreatectomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0005486', 'cui_str': 'Bioenergetics'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",6.0,0.0927947,"Overnight culture of islet preparations altered bioenergetic function, significantly decreasing SRC and maximal respiration ( P <0.001).","[{'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'McDowell', 'Affiliation': 'Department of Inflammation & Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Khawla F', 'Initials': 'KF', 'LastName': 'Ali', 'Affiliation': 'Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Saloni', 'Initials': 'S', 'LastName': 'Lad', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Vicente T', 'Initials': 'VT', 'LastName': 'San Martin', 'Affiliation': 'Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Bottino', 'Affiliation': 'Institute for Cellular Therapeutics, Allegheny Health Network Research Institute, Pittsburgh, PA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Digestive Disease Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Stevens', 'Affiliation': 'Digestive Disease Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wilke', 'Affiliation': 'Orthopaedic & Rheumatologic Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Department of Inflammation & Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Betul', 'Initials': 'B', 'LastName': 'Hatipoglu', 'Affiliation': 'Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, OH, USA.'}]",Cell transplantation,['10.1177/09636897211057440']
2680,34747558,"Warmed and humidified insufflation to prevent perioperative hypothermia and improve quality of recovery in elective laparoscopic colorectal resection patients: A feasibility, triple blind randomised controlled trial.","AIM


The use of standard CO 2  for insufflation during laparoscopic colorectal surgery may be associated with cooling and drying of the peritoneal cavity contributing to perioperative hypothermia. The aim was the assess the feasibility of a study comparing insufflation of warmed, humidified CO 2  (WHCO2) (using HumiGard, Fisher and Paykel Healthcare) with standard measures and its impact on the quality of recovery of surgical patients.
METHODS


Single-centre, triple-blind, feasibility, randomised controlled trial of adults scheduled for planned laparoscopic colorectal surgery. The primary outcome was recruitment. Secondary outcomes included feasibility of blinding, acceptability to patients, and suitability of objective measures: patient-reported quality of recovery using a validated questionnaire (QoR-40), patient pain scores, and semi-continuous core temperature measurements.
RESULTS


Thirty-nine participants were randomised to either WHCO2 group (n=19) or standard care alone (n=20). Recruitment to the study was successful and acceptable to patients. Blinding of the surgeons, patients, and assessors was effective. Response rates to QoR-40 were high, but ceiling effects were observed indicating the tool was unsuitable in this population. Less patients in the WHCO2 group reported post-operative nausea and vomiting (PONV) at days 1 (53%vs 65%) and 3 (37%vs 60%). Median hospital length of stay was 5.5 days in the standard care group and 4 days in the WHCO2 group.
CONCLUSIONS


A study of WHCO2 for insufflation in laparoscopic colorectal surgery is highly acceptable to both patients and researchers. Potential reductions in PONV and hospital length of stay in patients treated with WHCO2 merits further investigation. The design of the full-scale RCT will benefit from this feasibility study.",2021,"Median hospital length of stay was 5.5 days in the standard care group and 4 days in the WHCO2 group.
","['elective laparoscopic colorectal resection patients', 'Thirty-nine participants']","['planned laparoscopic colorectal surgery', 'standard CO', 'WHCO2', 'insufflation of warmed, humidified CO 2  (WHCO2) (using HumiGard, Fisher and Paykel Healthcare', 'standard care alone', 'Warmed and humidified insufflation']","['Median hospital length of stay', 'feasibility of blinding, acceptability to patients, and suitability of objective measures: patient-reported quality of recovery using a validated questionnaire (QoR-40), patient pain scores, and semi-continuous core temperature measurements', 'post-operative nausea and vomiting (PONV', 'quality of recovery', 'Response rates to QoR-40', 'PONV and hospital length of stay']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816447', 'cui_str': '39'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",39.0,0.32215,"Median hospital length of stay was 5.5 days in the standard care group and 4 days in the WHCO2 group.
","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Reeves', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, CF10 3AT.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Cedar, Cardiff & Vale University Health Board, Heath Park, CF14 4UJ.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bird', 'Affiliation': 'University Hospital of Wales, Cardiff and Vale University Health Board, Cardiff, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shinkwin', 'Affiliation': 'University Hospital of Wales, Cardiff and Vale University Health Board, Cardiff, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cornish', 'Affiliation': 'University Hospital of Wales, Cardiff and Vale University Health Board, Cardiff, United Kingdom.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Torkington', 'Affiliation': ''}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15984']
2681,34747516,Cholecalciferol supplementation attenuates bone loss in incident kidney transplant recipients: A prespecified secondary endpoint analysis of a randomized controlled trial.,"Vitamin D deficiency, persistent hyperparathyroidism, and bone loss are common after kidney transplantation (KTx). However, limited evidence exists regarding the effects of cholecalciferol supplementation on parathyroid hormone (PTH) and bone loss after KTx. In this prespecified secondary endpoint analysis of a randomized controlled trial, we evaluated changes in PTH, bone metabolic markers, and bone mineral density (BMD). At 1-month post-transplant, we randomized 193 patients to an 11-month intervention with cholecalciferol (4000 IU/day) or placebo. The median baseline 25-hydroxyvitamin D (25[OH]D) level was 10 ng/mL and 44% of participants had osteopenia or osteoporosis. At the end of the study, the median 25(OH)D level was increased to 40 ng/mL in the cholecalciferol group and substantially unchanged in the placebo group. Compared with placebo, cholecalciferol significantly reduced whole PTH concentrations (between-group difference of -15% [95% confidence interval (CI), -25 to -3]), with greater treatment effects in subgroups with lower 25(OH)D, lower serum calcium, or higher estimated glomerular filtration rate (P int   < 0.05). The percent change in lumbar spine (LS) BMD from before KTx to 12-month post-transplant was -0.2% (95% CI, -1.4 to 0.9) in the cholecalciferol group and - 1.9% (95% CI, -3.0 to -0.8) in the placebo group, with a significant between-group difference (1.7% [95% CI, 0.1 to 3.3]). The beneficial effect of cholecalciferol on LS BMD was prominent in patients with low bone mass (P int   < 0.05). Changes in serum calcium, phosphate, bone metabolic markers, and BMD at the distal radius were not different between groups. In mediation analyses, change in whole PTH levels explained 39% of treatment effects on BMD change. In conclusion, 4000 IU/day cholecalciferol significantly reduced PTH levels and attenuated LS BMD loss after KTx. This regimen has the potential to eliminate vitamin D deficiency and provides beneficial effects on bone health even under glucocorticoid treatment This article is protected by copyright. All rights reserved.",2021,"Changes in serum calcium, phosphate, bone metabolic markers, and BMD at the distal radius were not different between groups.",['incident kidney transplant recipients'],"['cholecalciferol', 'Cholecalciferol supplementation', 'placebo, cholecalciferol', 'placebo', 'cholecalciferol supplementation']","['median baseline 25-hydroxyvitamin D (25[OH]D) level', 'parathyroid hormone (PTH) and bone loss', 'PTH levels and attenuated LS BMD loss', 'Vitamin D deficiency, persistent hyperparathyroidism, and bone loss', 'PTH, bone metabolic markers, and bone mineral density (BMD', 'median 25(OH)D level', 'osteopenia or osteoporosis', 'BMD change', 'glomerular filtration rate', 'bone loss', 'lumbar spine (LS) BMD', 'serum calcium, phosphate, bone metabolic markers, and BMD at the distal radius', 'LS BMD', 'whole PTH concentrations']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020502', 'cui_str': 'Hyperparathyroidism'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",193.0,0.32474,"Changes in serum calcium, phosphate, bone metabolic markers, and BMD at the distal radius were not different between groups.","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tsujita', 'Affiliation': 'Department of Transplant Nephrology and Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Doi', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Obi', 'Affiliation': 'Division of Nephrology, University of Tennessee Health Science Center, Memphis, USA.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Hamano', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Toshihide', 'Initials': 'T', 'LastName': 'Tomosugi', 'Affiliation': 'Department of Transplant Nephrology and Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Futamura', 'Affiliation': 'Department of Transplant Nephrology and Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Transplant Nephrology and Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Hiramitsu', 'Affiliation': 'Department of Transplant Nephrology and Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Goto', 'Affiliation': 'Department of Transplant Nephrology and Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Isaka', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Asami', 'Initials': 'A', 'LastName': 'Takeda', 'Affiliation': 'Department of Nephrology, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Narumi', 'Affiliation': 'Department of Transplant Nephrology and Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Watarai', 'Affiliation': 'Department of Transplant Nephrology and Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4469']
2682,34747448,"Efficacy, Safety, and Tolerability of Ansofaxine (LY03005) Extended-Release Tablet for Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Phase 2 Clinical Trial.","BACKGROUND


Ansofaxine (LY03005) extended-release (ER) tablet is a potential triple reuptake inhibitor of serotonin, norepinephrine, and dopamine. This study assessed the efficacy, safety, and appropriate dosage of ansofaxine for the treatment of major depressive disorder (MDD).
METHOD


A multicenter, randomized, double-blind, placebo-controlled, dose-finding, Phase 2 clinical trial was conducted in China. Eligible patients with MDD (18-65 years) were randomly assigned to receive fixed-dose ansofaxine ER tablets (40, 80, 120, or 160 mg/day) or placebo for 6 weeks. The primary outcome measure was a change in the total score on the 17-item Hamilton Depression Rating Scale (HAMD17) from baseline to week 6.
RESULT


A total of 260 patients were recruited from October 2015 to September 2017. 255 patients received the study drug as the following: 40 mg (n = 52), 80 mg (n = 52), 120 mg (n = 51), and 160 mg (n = 51) ansofaxine and placebo (n = 49). Significant differences were found in mean changes in HAMD17 total scores at week 6 in the four ansofaxine groups vs. placebo (-12.46; χ  2 = -9.71, p = 0.0447). All doses of ansofaxine were generally well-tolerated. Treatment-related adverse events (TRAEs) occurred in 141 patients (303 cases), giving TRAEs incidence rates of 51.92%, 65.38%, 56.86%, and 62.75%in the 40, 80, 120, and 160 mg ansofaxine groups and 38.78% in the placebo group.
CONCLUSION


Active doses (40, 80, 120, and 160 mg per day) of ansofaxine in a controlled setting were safe, tolerated, and effective in improving depression symptoms in MDD patients.",2021,"Significant differences were found in mean changes in HAMD17 total scores at week 6 in the four ansofaxine groups vs. placebo (-12.46; χ  2 = -9.71, p = 0.0447).","['Major Depressive Disorder', '255 patients', 'major depressive disorder (MDD', 'MDD patients', '260 patients were recruited from October 2015 to September 2017', 'Eligible patients with MDD (18-65 years']","['Placebo', 'ansofaxine', 'Ansofaxine (LY03005) extended-release (ER) tablet', 'Ansofaxine (LY03005) Extended-Release Tablet', 'ansofaxine and placebo', 'placebo', 'fixed-dose ansofaxine ER tablets']","['giving TRAEs incidence rates', 'tolerated', 'total score on the 17-item Hamilton Depression Rating Scale (HAMD17', 'depression symptoms', 'Efficacy, Safety, and Tolerability', 'HAMD17 total scores', 'efficacy, safety', 'adverse events (TRAEs']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0991507', 'cui_str': 'Prolonged-release oral tablet'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",260.0,0.359184,"Significant differences were found in mean changes in HAMD17 total scores at week 6 in the four ansofaxine groups vs. placebo (-12.46; χ  2 = -9.71, p = 0.0447).","[{'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Mi', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Fude', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Beijing Huilongguan Hospital, Beijing, China.'}, {'ForeName': 'Huafang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai, China.'}, {'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Lehua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Qingrong', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': ""First Affiliated Hospital of the Fourth Military Medical University (Air Force Medical University), Xi'an, China.""}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Wuxi Mental Health Center, Wuxi, China.'}, {'ForeName': 'Kerang', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'First Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': 'Second Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Beijing Anding Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Jielai', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Fourth Military Medical University of Chinese People's Liberation Army, Statistical Analysis Teaching and Research Section, Xi'an, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Yuan', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Yantai University, Yantai, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyab074']
2683,34747807,"Effect of Monochromatic Infrared Energy on Quality of Life and Intraepidermal Nerve Fiber Density in Painful Diabetic Neuropathy: A Randomized, Sham Control Study.","Background


Monochromatic infrared energy (MIRE) has evoked mixed results for symptomatic relief of painful diabetic peripheral neuropathy (DPN). However, intraepidermal nerve-fiber density (IENFD) the gold standard for small-fiber neuropathy has not been evaluated.
Objective


We assessed the IENFD, pain symptoms and quality of life (QoL) with MIRE therapy compared to placebo in painful DPN.
Material and Methods


Participants with type 2 diabetes and painful DPN were randomized to receive MIRE or sham therapy dosed thrice a week for 12 weeks. Quantitative assessment of IENFD was performed from 3 mm skin punch-biopsy specimens at baseline and after 12 weeks. We also assessed the QoL with Norfolk QOL, symptom severity with visual analogue scale (VAS), and neuropathy assessment with Michigan neuropathy severity instrument and neuropathy disability score.
Results


Thirty-eight participants were enrolled and 30 completed the study protocol. The mean age of participants in MIRE cohort was 59.1 ± 9.2 years, duration of diabetes 12.9 ± 3.1 years, and symptom duration of 3.9 ± 3.7 months. The mean IENFD was 0.90 ± 0.73/mm 2  (P < 0.01) and 1.71 ± 1.11/mm 2  in the MIRE cohort and 0.60 ± 0.89/mm 2  and 2.17 ± 0.98/mm 2  (P < 0.01) in sham cohort at baseline and after 3 months. The median decline in VAS was 5.1 (4.0-7.6) and 3.0 (0.4-5.6) points (intergroup difference, P = 0.01); and an increase in Norfolk QoL-DN by 15 (11-18) and 4 (4-14.2) points (intergroup difference, P = 0.021) in MIRE and sham cohort, respectively after 3 months.
Conclusions


MIRE therapy does not increase IENFD over short-term usage. However, MIRE therapy provides symptomatic benefit and improves QoL in patients with painful DPN.",2021,The mean IENFD was 0.90 ± 0.73/mm 2  (P < 0.01) and 1.71 ±,"['Participants with type 2 diabetes and painful DPN', 'Thirty-eight participants were enrolled and 30 completed the study protocol', 'patients with painful DPN', 'The mean age of participants in MIRE cohort was 59.1 ± 9.2 years, duration of diabetes 12.9 ± 3.1 years, and symptom duration of 3.9 ± 3.7 months', 'Painful Diabetic Neuropathy']","['\n\n\nMonochromatic infrared energy (MIRE', 'IENFD', 'MIRE therapy', 'MIRE', 'placebo', 'Monochromatic Infrared Energy']","['IENFD, pain symptoms and quality of life (QoL', 'IENFD', 'mean IENFD', 'median decline in VAS', 'Quality of Life and Intraepidermal Nerve Fiber Density', 'QoL with Norfolk QOL, symptom severity with visual analogue scale (VAS), and neuropathy assessment with Michigan neuropathy severity instrument and neuropathy disability score', 'Norfolk QoL-DN']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205290', 'cui_str': 'Monochromatic'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}]","[{'cui': 'C0205290', 'cui_str': 'Monochromatic'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0027749', 'cui_str': 'Nerve fiber'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027749', 'cui_str': 'Nerve fiber'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0454866', 'cui_str': 'Norfolk'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",38.0,0.059921,The mean IENFD was 0.90 ± 0.73/mm 2  (P < 0.01) and 1.71 ±,"[{'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Endocrinology, Histopathology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Pavan', 'Initials': 'P', 'LastName': 'Uppula', 'Affiliation': 'Department of Endocrinology, Histopathology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Saikia', 'Affiliation': 'Department of Endocrinology, Histopathology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Bhansali', 'Affiliation': 'Department of Endocrinology, Histopathology, PGIMER, Chandigarh, India.'}]",Neurology India,['10.4103/0028-3886.329614']
2684,34748059,The impact of drainage pathways on the detection of nodal metastases in prostate cancer: a phase II randomized comparison of intratumoral vs intraprostatic tracer injection for sentinel node detection.,"INTRODUCTION


Previous studies indicated that location and amount of detected sentinel lymph nodes (SLNs) in prostate cancer (PCa) are influenced where SLN-tracer is deposited within the prostate. To validate whether intratumoral (IT) tracer injection helps to increase identification of tumor-positive lymph nodes (LNs) better than intraprostatic (IP) tracer injection, a prospective randomized phase II trial was performed.
METHODS


PCa patients with a > 5% risk of lymphatic involvement were randomized between ultrasound-guided transrectal injection of indocyanine green-[ 99m Tc]Tc-nanocolloid in 2 depots of 1 mL in the tumor (n = 55, IT-group) or in 4 depots of 0.5 mL in the peripheral zone of the prostate (n = 58, IP-group). Preoperative lymphoscintigraphy and SPECT/CT were used to define the location of the SLNs. SLNs were dissected using combination of radio- and fluorescence-guidance, followed by extended pelvic LN dissection and robot-assisted radical prostatectomy. Outcome measurements were number of tumor-bearing SNs, tumor-bearing LNs, removed nodes, number of patients with nodal metastases, and metastasis-free survival (MFS) of 4-7-year follow-up data.
RESULTS


IT-injection did not result in significant difference of removed SLNs (5.0 vs 6.0, p = 0.317) and histologically positive SLNs (28 vs 22, p = 0.571). However, in IT-group, the SLN-positive nodes were 73.7% of total positive nodes compared to 37.3% in IP-group (p = 0.015). Moreover, significantly more node-positive patients were found in IT-group (42% vs 24%, p = 0.045), which did not result in worse MFS. In two patients (3.6%) from whom the IT-tracer injection only partly covered intraprostatic tumor spread, nodal metastases in ePLND without tumor-positive SNs were yielded.
CONCLUSIONS


The percentage-positive SLNs found after IT-injection were significantly higher compared to IP-injection. Significantly more node-positive patients were found using IT-injection, which did not affect MFS. IT-injection failed to detect nodal metastases from non-index satellite lesions. Therefore, we suggest to combine IT- and IP-tracer injections in men with visible tumor on imaging.",2021,The percentage-positive SLNs found after IT-injection were significantly higher compared to IP-injection.,"['prostate cancer', 'men with visible tumor on imaging', 'sentinel node detection', 'PCa patients with a\u2009>\u20095% risk of lymphatic involvement']","['intratumoral vs intraprostatic tracer injection', 'extended pelvic LN dissection and robot-assisted radical prostatectomy', 'combine IT- and IP-tracer injections', 'ultrasound-guided transrectal injection of indocyanine green', 'intraprostatic (IP) tracer injection', 'Preoperative lymphoscintigraphy and SPECT/CT', 'intratumoral (IT) tracer injection']","['removed SLNs', 'SLN-positive nodes', 'percentage-positive SLNs', 'number of tumor-bearing SNs, tumor-bearing LNs, removed nodes, number of patients with nodal metastases, and metastasis-free survival (MFS']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C1512969', 'cui_str': 'Intraprostatic route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0412375', 'cui_str': 'Radioisotope scan of lymphatic system'}, {'cui': 'C3472245', 'cui_str': 'Single photon emission computed tomography with computed tomography'}]","[{'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0475450', 'cui_str': 'Number of tumors'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}]",,0.0367899,The percentage-positive SLNs found after IT-injection were significantly higher compared to IP-injection.,"[{'ForeName': 'Esther M K', 'Initials': 'EMK', 'LastName': 'Wit', 'Affiliation': 'Department of Urology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. e.wit@nki.nl.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'van Beurden', 'Affiliation': 'Department of Urology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Gijs H', 'Initials': 'GH', 'LastName': 'Kleinjan', 'Affiliation': 'Department of Urology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Grivas', 'Affiliation': 'Department of Urology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Clarize M', 'Initials': 'CM', 'LastName': 'de Korne', 'Affiliation': 'Interventional Molecular Imaging Laboratory, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Buckle', 'Affiliation': 'Department of Urology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Maarten L', 'Initials': 'ML', 'LastName': 'Donswijk', 'Affiliation': 'Department of Nuclear Medicine, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Bekers', 'Affiliation': 'Department of Pathology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Fijs W B', 'Initials': 'FWB', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Urology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk G', 'Initials': 'HG', 'LastName': 'van der Poel', 'Affiliation': 'Department of Urology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-021-05580-0']
2685,34748017,Wearability and preference of mouthguard during sport in patients undergoing orthodontic treatment with fixed appliances: a randomized clinical trial.,"BACKGROUND


Orthodontic patients wearing fixed appliances are susceptible to traumatic dental injuries during a wide range of sporting activities. This randomized clinical trial investigated wearability and preference of mouthguards during sporting activities in patients undergoing orthodontic treatment with fixed appliances.
METHODS


A prospective three-arm crossover randomized clinical trial conducted in the UK. Thirty patients in active orthodontic treatment with fixed appliances undertaking at least 120 minutes of contact sport per 6-8-week observation period were randomly assigned to one of six mouthguard allocation sequences consisting of three mouthguard types: (MG1) custom-made laboratory constructed, (MG2) mouth-formed OPRO® Gold Braces, and (MG3) pre-fabricated Shock Doctor® Single Brace. Patients completed a nine-outcome 100-mm visual analogue scale (VAS) questionnaire relating to mouthguard wearability during sport. Once feedback was completed, subjects were allocated the next mouthguard in the sequence. At study-end, subjects were asked to identify their preferred mouthguard.
RESULTS


Twenty-four patients (median age = 13; inter-quartile range 12-14.5 years) completed n = 72 follow-up questionnaires with most playing rugby union or field hockey. Considering VAS score as a continuous variable, for comfort, stability, hardness, ability to breathe, ability to not cause nausea, and inclination to chew, and MG2 performed better than MG3. For categorization of VAS score into low (less than 80 mm) or high (at least 80 mm) wearability, for comfort, stability, ability to not cause nausea, and inclination to chew, MG1 and MG2 also rated superior to MG3. Patients preferred MG1 overall.
CONCLUSIONS


This randomized clinical trial found that during contact sport patients in fixed appliances reported superior wearability for custom-made and mouth-formed mouthguards in comparison to pre-fabricated. Overall, patients preferred custom-made mouthguards.
CLINICAL TRIALS REGISTRATION


ClinicalTrials.gov: NCT04588831.",2021,This randomized clinical trial found that during contact sport patients in fixed appliances reported superior wearability for custom-made and mouth-formed mouthguards in comparison to pre-fabricated.,"['Thirty patients in active orthodontic treatment with fixed appliances undertaking at least 120 minutes of contact sport per 6-8-week observation period', 'Orthodontic patients wearing fixed appliances', 'patients undergoing orthodontic treatment with fixed appliances', 'Twenty-four patients (median age = 13; inter-quartile range 12-14.5 years) completed n = 72 follow-up questionnaires with most playing rugby union or field hockey']","['six mouthguard allocation sequences consisting of three mouthguard types: (MG1) custom-made laboratory constructed, (MG2) mouth-formed OPRO® Gold Braces, and (MG3) pre-fabricated Shock Doctor® Single Brace']","['Wearability and preference', 'comfort, stability, hardness, ability to breathe, ability to not cause nausea, and inclination to chew, and MG2', 'nine-outcome 100-mm visual analogue scale (VAS) questionnaire relating to mouthguard wearability during sport']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0336924', 'cui_str': 'Contact sport'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0016074', 'cui_str': 'Field hockey'}]","[{'cui': 'C0026642', 'cui_str': 'Mouth Guards'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0566501', 'cui_str': 'Ability to breathe'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026642', 'cui_str': 'Mouth Guards'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]",,0.130607,This randomized clinical trial found that during contact sport patients in fixed appliances reported superior wearability for custom-made and mouth-formed mouthguards in comparison to pre-fabricated.,"[{'ForeName': 'Aneesh', 'Initials': 'A', 'LastName': 'Kalra', 'Affiliation': 'Department of Orthodontics, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Harrington', 'Affiliation': 'Department of Orthodontics, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Gursharan', 'Initials': 'G', 'LastName': 'Minhas', 'Affiliation': 'Department of Orthodontics, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Spyridon N', 'Initials': 'SN', 'LastName': 'Papageorgiou', 'Affiliation': 'Clinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich, Switzerland.'}, {'ForeName': 'Martyn T', 'Initials': 'MT', 'LastName': 'Cobourne', 'Affiliation': ""Centre for Craniofacial Development & Regeneration, Department of Orthodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, UK.""}]",European journal of orthodontics,['10.1093/ejo/cjab062']
2686,34748003,"Development and Assessment of a Clinical Calculator for Estimating the Likelihood of Recurrence and Survival Among Patients With Locally Advanced Rectal Cancer Treated With Chemotherapy, Radiotherapy, and Surgery.","Importance


Predicting outcomes in patients receiving neoadjuvant therapy for rectal cancer is challenging because of tumor downstaging. Validated clinical calculators that can estimate recurrence-free survival (RFS) and overall survival (OS) among patients with rectal cancer who have received multimodal therapy are needed.
Objective


To develop and validate clinical calculators providing estimates of rectal cancer recurrence and survival that are better for individualized decision-making than the American Joint Committee on Cancer (AJCC) staging system or the neoadjuvant rectal (NAR) score.
Design, Setting, and Participants


This prognostic study developed risk models, graphically represented as nomograms, for patients with incomplete pathological response using Cox proportional hazards and multivariable regression analyses with restricted cubic splines. Because patients with complete pathological response to neoadjuvant therapy had uniformly favorable outcomes, their predictions were obtained separately. The study included 1400 patients with stage II or III rectal cancer who received treatment with chemotherapy, radiotherapy, and surgery at 2 comprehensive cancer centers (Memorial Sloan Kettering [MSK] Cancer Center and Siteman Cancer Center [SCC]) between January 1, 1998, and December 31, 2017. Patients from the MSK cohort received chemoradiation, surgery, and adjuvant chemotherapy from January 1, 1998, to December 31, 2014; these patients were randomly assigned to either a model training group or an internal validation group. Models were externally validated using data from the SCC cohort, who received either chemoradiation, surgery, and adjuvant chemotherapy (chemoradiotherapy group) or short-course radiotherapy, consolidation chemotherapy, and surgery (total neoadjuvant therapy with short-course radiotherapy group) from January 1, 2009, to December 31, 2017. Data were analyzed from March 1, 2020, to January 10, 2021.
Exposures


Chemotherapy, radiotherapy, chemoradiotherapy, and surgery.
Main Outcomes and Measures


Recurrence-free survival and OS were the outcome measures, and the discriminatory performance of the clinical calculators was measured with concordance index and calibration plots. The ability of the clinical calculators to predict RFS and OS was compared with that of the AJCC staging system and the NAR score. The models for RFS and OS among patients with incomplete pathological response included postoperative pathological tumor category, number of positive lymph nodes, tumor distance from anal verge, and large- and small-vessel venous and perineural invasion; age was included in the risk model for OS. The final clinical calculators provided RFS and OS estimates derived from Kaplan-Meier curves for patients with complete pathological response and from risk models for patients with incomplete pathological response.
Results


Among 1400 total patients with locally advanced rectal cancer, the median age was 57.8 years (range, 18.0-91.9 years), and 863 patients (61.6%) were male, with tumors at a median distance of 6.7 cm (range, 0-15.0 cm) from the anal verge. The MSK cohort comprised 1069 patients; of those, 710 were assigned to the model training group and 359 were assigned to the internal validation group. The SCC cohort comprised 331 patients; of those, 200 were assigned to the chemoradiotherapy group and 131 were assigned to the total neoadjuvant therapy with short-course radiotherapy group. The concordance indices in the MSK validation data set were 0.70 (95% CI, 0.65-0.76) for RFS and 0.73 (95% CI, 0.65-0.80) for OS. In the external SCC data set, the concordance indices in the chemoradiotherapy group were 0.71 (95% CI, 0.62-0.81) for RFS and 0.72 (95% CI, 0.59-0.85) for OS; the concordance indices in the total neoadjuvant therapy with short-course radiotherapy group were 0.62 (95% CI, 0.49-0.75) for RFS and 0.67 (95% CI, 0.46-0.84) for OS. Calibration plots confirmed good agreement between predicted and observed events. These results compared favorably with predictions based on the AJCC staging system (concordance indices for MSK validation: RFS = 0.69 [95% CI, 0.64-0.74]; OS = 0.67 [95% CI, 0.58-0.75]) and the NAR score (concordance indices for MSK validation: RFS = 0.56 [95% CI, 0.50-0.63]; OS = 0.56 [95% CI, 0.46-0.66]). Furthermore, the clinical calculators provided more individualized outcome estimates compared with the categorical schemas (eg, estimated RFS for patients with AJCC stage IIIB disease ranged from 7% to 68%).
Conclusions and Relevance


In this prognostic study, clinical calculators were developed and validated; these calculators provided more individualized estimates of the likelihood of RFS and OS than the AJCC staging system or the NAR score among patients with rectal cancer who received multimodal treatment. The calculators were easy to use and applicable to both short- and long-course radiotherapy regimens, and they may be used to inform surveillance strategies and facilitate future clinical trials and statistical power calculations.",2021,The ability of the clinical calculators to predict RFS and OS was compared with that of the AJCC staging system and the NAR score.,"['1400 patients with stage II or III rectal cancer who received treatment with', 'patients receiving neoadjuvant therapy for rectal cancer', 'patients with rectal cancer who have received', 'patients with rectal cancer who received multimodal treatment', 'Patients from the MSK cohort received chemoradiation, surgery, and adjuvant chemotherapy from January 1, 1998, to December 31, 2014; these patients', '1400 total patients with locally advanced rectal cancer, the median age was 57.8 years (range, 18.0-91.9 years), and 863 patients (61.6%) were male, with tumors at a median distance of 6.7 cm (range, 0-15.0 cm) from the anal verge', 'Patients With Locally Advanced Rectal Cancer Treated With', '1069 patients; of those, 710 were assigned to the model training group and 359 were assigned to the internal validation group', ' and surgery at 2 comprehensive cancer centers (Memorial Sloan Kettering [MSK] Cancer Center and Siteman Cancer Center [SCC]) between January 1, 1998, and December 31, 2017']","['total neoadjuvant therapy with short-course radiotherapy', 'Chemotherapy, Radiotherapy, and Surgery', 'Exposures\n\n\nChemotherapy, radiotherapy, chemoradiotherapy, and surgery', 'chemoradiation, surgery, and adjuvant chemotherapy (chemoradiotherapy group) or short-course radiotherapy, consolidation chemotherapy, and surgery (total neoadjuvant therapy with short-course radiotherapy', 'chemoradiotherapy', 'model training group or an internal validation group', 'chemotherapy, radiotherapy', 'multimodal therapy']","['recurrence-free survival (RFS) and overall survival (OS', 'Measures\n\n\nRecurrence-free survival and OS', 'NAR score', 'Recurrence and Survival', 'discriminatory performance of the clinical calculators']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}]",1400.0,0.227395,The ability of the clinical calculators to predict RFS and OS was compared with that of the AJCC staging system and the NAR score.,"[{'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Weiser', 'Affiliation': 'Colorectal Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Ajaratu', 'Initials': 'A', 'LastName': 'Keshinro', 'Affiliation': 'Colorectal Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Chapman', 'Affiliation': 'Department of Surgery, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Bauer', 'Affiliation': 'Department of Surgery, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Mutch', 'Affiliation': 'Department of Surgery, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Parag J', 'Initials': 'PJ', 'LastName': 'Parikh', 'Affiliation': 'Department of Radiation Oncology, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cercek', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Saltz', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Gollub', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Romesser', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Crane', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jinru', 'Initials': 'J', 'LastName': 'Shia', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York, New York.'}, {'ForeName': 'Arnold J', 'Initials': 'AJ', 'LastName': 'Markowitz', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Garcia-Aguilar', 'Affiliation': 'Colorectal Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Mithat', 'Initials': 'M', 'LastName': 'Gönen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2021.33457']
2687,34747997,"Factors influencing participants' engagement with an interactive text-message intervention to improve sun protection behaviors: ""SunText"" randomized controlled trial.","There is growing evidence suggesting that text-message-based interventions are effective to promote sun protection behaviors. However, it is still unclear how engagement and adherence with the intervention messages can be optimized through intervention design. This study evaluated the effect of different combinations of personalized and two-way interactive messages on participant engagement with a theory-based skin cancer prevention intervention. In the SunText study conducted in February-July 2019 in Queensland, Australia participants 18-40 years were randomized to four different text message schedules using a Latin square design. This study analyzed if the order and intensity in which the schedules were received were associated with participants' level of engagement, and if this differed by demographic factors. Out of the 389 participants enrolled in the study, 375 completed the intervention period and remained for analysis. The overall intervention engagement rate was 71% and decreased from the beginning to the end of the study (82.2%-61.4%). The group starting with personalized, but not interactive messaging showed the lowest engagement rate. The intervention involving interactive messages three times a week for 4 weeks achieved the highest engagement rate. The intervention with increasing frequency (personalized and interactive three times a week for 2 weeks; then daily for 2 weeks) had lower engagement than intervention with constant or decreasing frequency. Engagement with two-way interactive messages was high across all intervention groups. Results suggest enhanced engagement with constant or decreasing message frequency compared to increasing frequency.",2021,"The group starting with personalized, but not interactive messaging showed the lowest engagement rate.","['February-July 2019 in Queensland, Australia participants 18-40 years', '389 participants enrolled in the study, 375 completed the intervention period and remained for analysis']","['interactive text-message intervention', 'personalized and two-way interactive messages on participant engagement with a theory-based skin cancer prevention intervention']","['overall intervention engagement rate', 'sun protection behaviors']","[{'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517752', 'cui_str': '389'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",389.0,0.027186,"The group starting with personalized, but not interactive messaging showed the lowest engagement rate.","[{'ForeName': 'Carina V', 'Initials': 'CV', 'LastName': 'Silva', 'Affiliation': 'Centre for Health Services Research, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Horsham', 'Affiliation': 'Centre for Health Services Research, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Kou', 'Initials': 'K', 'LastName': 'Kou', 'Affiliation': 'Cancer Council Queensland, Brisbane, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Baade', 'Affiliation': 'Cancer Council Queensland, Brisbane, Australia.'}, {'ForeName': 'H Peter', 'Initials': 'HP', 'LastName': 'Soyer', 'Affiliation': 'The University of Queensland Diamantina Institute, The University of Queensland, Dermatology Research Centre, Brisbane, Australia.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Janda', 'Affiliation': 'Centre for Health Services Research, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}]",Translational behavioral medicine,['10.1093/tbm/ibab135']
2688,34748133,Brief Report: A Brief Video Intervention for Increasing Autism Knowledge in a General Population Sample.,"As many individuals in the general population will likely interact with autistic persons in various contexts, ensuring adequate autism knowledge and awareness is important. Increased knowledge of autism has been linked to positive outcomes such as a reduction in explicit bias against autism by non-autistic adults and an increase in service quality for autistic individuals provided by indirect professionals. For this study we developed an informational video about autism and employed a randomized control trial to evaluate its effectiveness at increasing autism awareness in a general population sample. Participants were randomly assigned to the intervention (n = 80) or active control group (n = 72). Results from a repeated measures analysis of variance indicated that the video intervention was effective at increasing knowledge about autism. Results from this study can be applied to future educational efforts aimed at increasing awareness about autism among the general population.",2021,Increased knowledge of autism has been linked to positive outcomes such as a reduction in explicit bias against autism by non-autistic adults and an increase in service quality for autistic individuals provided by indirect professionals.,['autism awareness in a general population sample'],"['video intervention', 'Video Intervention', 'active control group']",['service quality'],"[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0375845,Increased knowledge of autism has been linked to positive outcomes such as a reduction in explicit bias against autism by non-autistic adults and an increase in service quality for autistic individuals provided by indirect professionals.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ha', 'Affiliation': 'Department of Psychology, Utah State University, 2810 Old Main Hill, Logan, UT, 84322, USA.'}, {'ForeName': 'Maryellen Brunson', 'Initials': 'MB', 'LastName': 'McClain', 'Affiliation': 'Department of Psychology, Utah State University, 2810 Old Main Hill, Logan, UT, 84322, USA. maryellen.mcclainverdoes@usu.edu.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Covington', 'Affiliation': 'Department of Psychology, Utah State University, 2810 Old Main Hill, Logan, UT, 84322, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Golson', 'Affiliation': 'Department of Psychology, Utah State University, 2810 Old Main Hill, Logan, UT, 84322, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-021-05341-w']
2689,34742368,"Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial.","BACKGROUND


Compared with visual angiographic assessment, pressure wire-based physiological measurement more accurately identifies flow-limiting lesions in patients with coronary artery disease. Nonetheless, angiography remains the most widely used method to guide percutaneous coronary intervention (PCI). In FAVOR III China, we aimed to establish whether clinical outcomes might be improved by lesion selection for PCI using the quantitative flow ratio (QFR), a novel angiography-based approach to estimate the fractional flow reserve.
METHODS


FAVOR III China is a multicentre, blinded, randomised, sham-controlled trial done at 26 hospitals in China. Patients aged 18 years or older, with stable or unstable angina pectoris or patients who had a myocardial infarction at least 72 h before screening, who had at least one lesion with a diameter stenosis of 50-90% in a coronary artery with a reference vessel of at least 2·5 mm diameter by visual assessment were eligible. Patients were randomly assigned to a QFR-guided strategy (PCI performed only if QFR ≤0·80) or an angiography-guided strategy (PCI based on standard visual angiographic assessment). Participants and clinical assessors were masked to treatment allocation. The primary endpoint was the 1-year rate of major adverse cardiac events, a composite of death from any cause, myocardial infarction, or ischaemia-driven revascularisation. The primary analysis was done in the intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT03656848).
FINDINGS


Between Dec 25, 2018, and Jan 19, 2020, 3847 patients were enrolled. After exclusion of 22 patients who elected not to undergo PCI or who were withdrawn by their physicians, 3825 participants were included in the intention-to-treat population (1913 in the QFR-guided group and 1912 in the angiography-guided group). The mean age was 62·7 years (SD 10·1), 2699 (70·6%) were men and 1126 (29·4%) were women, 1295 (33·9%) had diabetes, and 2428 (63·5%) presented with an acute coronary syndrome. The 1-year primary endpoint occurred in 110 (Kaplan-Meier estimated rate 5·8%) participants in the QFR-guided group and in 167 (8·8%) participants in the angiography-guided group (difference, -3·0% [95% CI -4·7 to -1·4]; hazard ratio 0·65 [95% CI 0·51 to 0·83]; p=0·0004), driven by fewer myocardial infarctions and ischaemia-driven revascularisations in the QFR-guided group than in the angiography-guided group.
INTERPRETATION


In FAVOR III China, among patients undergoing PCI, a QFR-guided strategy of lesion selection improved 1-year clinical outcomes compared with standard angiography guidance.
FUNDING


Beijing Municipal Science and Technology Commission, Chinese Academy of Medical Sciences, and the National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital.",2021,"The 1-year primary endpoint occurred in 110 (Kaplan-Meier estimated rate 5·8%) participants in the QFR-guided group and in 167 (8·8%) participants in the angiography-guided group (difference, -3·0% [95% CI -4·7 to -1·4]; hazard ratio 0·65","['Between Dec 25, 2018, and Jan 19, 2020, 3847 patients were enrolled', 'Patients aged 18 years or older, with stable or unstable angina pectoris or patients who had a myocardial infarction at least 72 h before screening, who had at least one lesion with a diameter stenosis of 50-90% in a coronary artery with a reference vessel of at least 2·5 mm diameter by visual assessment were eligible', '22 patients who elected not to undergo PCI or who were withdrawn by their physicians, 3825 participants were included in the intention-to-treat population (1913 in the QFR-guided group and 1912 in the angiography-guided group', 'patients with coronary artery disease', 'The mean age was 62·7 years (SD 10·1), 2699 (70·6%) were men and 1126 (29·4%) were women, 1295 (33·9%) had diabetes, and 2428 (63·5%) presented with an acute coronary syndrome', '26 hospitals in China']","['visual angiographic assessment, pressure wire-based physiological measurement', 'Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China', 'QFR-guided strategy (PCI performed only if QFR ≤0·80) or an angiography-guided strategy (PCI based on standard visual angiographic assessment']","['myocardial infarctions and ischaemia-driven revascularisations', '1-year rate of major adverse cardiac events, a composite of death from any cause, myocardial infarction, or ischaemia-driven revascularisation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517556', 'cui_str': '1295'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",3847.0,0.542874,"The 1-year primary endpoint occurred in 110 (Kaplan-Meier estimated rate 5·8%) participants in the QFR-guided group and in 167 (8·8%) participants in the angiography-guided group (difference, -3·0% [95% CI -4·7 to -1·4]; hazard ratio 0·65","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, National Clinical Research Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: bxu@citmd.com.'}, {'ForeName': 'Shengxian', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, National Clinical Research Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zening', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': ""Jian'an"", 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, the Sixth Medical Centre, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pu', 'Affiliation': 'Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lianglong', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': 'Department of Cardiology, Huadong Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xuebo', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Tongji Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Chengxing', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': ""Department of Cardiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yaojun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Xuzhou Third People's Hospital, Xuzhou Medical University, Xuzhou, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': ""Department of Cardiology, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, China.""}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Shanghai Jiao Tong University-Pulse Medical Imaging Technology Joint Laboratory, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Medical Research and Biometrics Centre, National Centre for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos IDISSC, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research and Biometrics Centre, National Centre for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Fearon', 'Affiliation': 'Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine and VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Kefei', 'Initials': 'K', 'LastName': 'Dou', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, National Clinical Research Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Centre, New York, NY, USA; The Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Yongjian', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, National Clinical Research Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Ireland; NHLI, Imperial College London, London, UK.'}, {'ForeName': 'Weixian', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, National Clinical Research Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, National Clinical Research Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Centre, New York, NY, USA; The Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, National Clinical Research Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Cardiovascular Research Foundation, New York, NY, USA; The Zena and Michael A Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)02248-0']
2690,34742353,Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol.,"BACKGROUND


Tuberculosis (TB) caused Mycobacterium tuberculosis (M.tb) is one of infectious disease that lead a large number of morbidity and mortality all over the world. Although no reliable evidence has been found, it is considered that combining chemotherapeutic drugs with Chinese herbs can significantly improves the cure rate and the clinical therapeutic effect.
METHODS


Multi-drug resistant pulmonary tuberculosis (MDR-PTB, n = 258) patients with Qi-yin deficiency syndrome will be randomly assigned into a treatment group (n = 172) or control/placebo group (n = 86). The treatment group will receive the chemotherapeutic drugs combined with Chinese herbs granules (1 + 3 granules), while the control group will receive the chemotherapeutic drugs combined with Chinese herbs placebo (1 + 3 placebo granules). In addition, MDR-PTB (n = 312) patients with Yin deficiency lung heat syndrome will be randomly assigned to a treatment (n = 208) or control/placebo (n = 104) group. The treatment group will receive the chemotherapeutic regimen combined with Chinese herbs granules (2 + 4 granules), while the control group will receive the chemotherapeutic drugs and Chinese herbs placebo (2 + 4 placebo granules). The primary outcome is cure rate, the secondary outcomes included time to sputum culture conversion, lesion absorption rate and cavity closure rate. BACTEC™ MGIT™ automated mycobacterial detection system will be used to evaluate the M.tb infection and drug resistance. Chi-square test and Cox regression will be conducted with SAS 9.4 Statistical software to analyze the data.
DISCUSSION


The treatment cycle for MDR-PTB using standardized modern medicine could cause lengthy substantial side effects. Chinese herbs have been used for many years to treat MDR-PTB, but are without high-quality evidence. Hence, it is unknown whether Chinese herbs enhances the clinical therapeutic effect of synthetic drugs for treating MDR-PTB. Therefore, this study will be conducted to evaluate the clinical therapeutic effect of combining Chinese herbs and chemotherapeutic drugs to treat MDR-PTB cases. It will assist in screening new therapeutic drugs and establishing treatment plan that aims to improve the clinical therapeutic effect for MDR-PTB patients.
TRIAL REGISTRATION


This trial was registered at ClinicalTrials.gov (ChiCTR1900027720) on 24 November 2019 (prospective registered).",2021,"The primary outcome is cure rate, the secondary outcomes included time to sputum culture conversion, lesion absorption rate and cavity closure rate.","['n\u2009=\u2009312) patients with Yin deficiency lung heat syndrome', 'Multi-drug resistant pulmonary tuberculosis (MDR-PTB, n\u2009=\u2009258) patients with Qi-yin deficiency syndrome', 'China', '24 November 2019 (prospective registered']","['MDR-PTB', 'chemotherapeutic regimen combined with Chinese herbs granules (2\u2009+\u20094 granules), while the control group will receive the chemotherapeutic drugs and Chinese herbs placebo', 'chemotherapeutic drugs combined with Chinese herbs granules', 'control/placebo', 'integrating short-course chemotherapy with Chinese herbs', 'chemotherapeutic drugs combined with Chinese herbs placebo']","['time to sputum culture conversion, lesion absorption rate and cavity closure rate', 'cure rate']","[{'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085257', 'cui_str': 'Yin deficiency'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0242640', 'cui_str': 'Multiple-drug resistance'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0242640', 'cui_str': 'Multiple-drug resistance'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",,0.18478,"The primary outcome is cure rate, the secondary outcomes included time to sputum culture conversion, lesion absorption rate and cavity closure rate.","[{'ForeName': 'Shun-Xian', 'Initials': 'SX', 'LastName': 'Zhang', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': ""Shanghai University of Traditional Chinese Medicine, 1200 Cai Lun road, Shanghai, 201203, People's Republic of China.""}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'Tian', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Hui-Yong', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Zi-Feng', 'Initials': 'ZF', 'LastName': 'Ma', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Xian-Wei', 'Initials': 'XW', 'LastName': 'Wu', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Yu-Wei', 'Initials': 'YW', 'LastName': 'Jiang', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Shao-Yan', 'Initials': 'SY', 'LastName': 'Zhang', 'Affiliation': 'Center for Energy Metabolism and Reproduction, Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, Shenzhen, 518055, China. zhangshaoyan000@163.com.'}, {'ForeName': 'Zhen-Hui', 'Initials': 'ZH', 'LastName': 'Lu', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China. Dr_luzh@shutcm.edu.cn.""}]",Infectious diseases of poverty,['10.1186/s40249-021-00913-5']
2691,34742345,Efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial.,"BACKGROUND


Insomnia is a common sleeping disorder which affects the quality of life which can bring harms to physical and mental health of human beings and even economic development. Traditional Chinese medicine (TCM) plays an outstanding role in treating chronic diseases and alleviating their symptoms. Therefore, the purpose of this study is to assess the treatment efficacy in patients with insomnia treated with abdomen-rubbing qigong exercise (ARQE). In addition, the brain function changes of patients will be explored by resting state functional magnetic resonance imaging (rs-fMRI).
METHOD/DESIGN


This trial is a randomized, single-blind, controlled study planned to transpire between July 1, 2020, and July 31, 2021. A sample size of 114 participants (57 per group) with chronic insomnia will be randomly assigned to receive ARQE or CBTI for 8 weeks. The study duration will be 13 weeks, including a 1-week screening period, 8 weeks of intervention, and another 4 weeks of follow-up. The primary outcome is the Pittsburgh sleep quality index scores. Secondary outcomes include insomnia severity index, gastrointestinal symptom rating scale, the Hamilton Depression Scale, and rs-fMRI scan. The adverse events will be in control.
DISCUSSION


The results of this study will help to clarify the efficacy of ARQE in the treatment of insomnia and try to use rs-fMRI technology to explore the brain function changes of ARQE in improving sleep quality in patients with insomnia disorder. If the results are as expected, this study will provide high-quality evidence for the treatment of insomnia with ARQE.
TRIAL REGISTRATION


China Clinical Registration Agency ChiCTR1900028009 . Registered on 19 December 2019.",2021,"Secondary outcomes include insomnia severity index, gastrointestinal symptom rating scale, the Hamilton Depression Scale, and rs-fMRI scan.","['chronic insomnia', '114 participants (57 per group) with chronic insomnia', 'patients with insomnia disorder', 'July 1, 2020, and July 31, 2021', 'patients with insomnia treated with abdomen-rubbing qigong exercise (ARQE']","['ARQE or CBTI', 'abdomen-rubbing qigong exercise', 'ARQE', 'Traditional Chinese medicine (TCM']","['Pittsburgh sleep quality index scores', 'adverse events', 'insomnia severity index, gastrointestinal symptom rating scale, the Hamilton Depression Scale, and rs-fMRI scan']","[{'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",,0.161156,"Secondary outcomes include insomnia severity index, gastrointestinal symptom rating scale, the Hamilton Depression Scale, and rs-fMRI scan.","[{'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Ziji', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Ruiping', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Shanghai Skin Disease Hospital, Shanghai, 200050, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yao', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. doctoryaofei@126.com.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. fangmin19650510@163.com.'}]",Trials,['10.1186/s13063-021-05528-7']
2692,34758516,The effect of the anticholinergic burden on duration and severity of delirium in older hip-surgery patients with and without haloperidol prophylaxis: A post hoc analysis.,"BACKGROUND


Anticholinergic acting drugs have been associated with delirium in older patients.
OBJECTIVE


To examine the association between the anticholinergic burden (ACB) and the duration and severity of delirium in older hip-surgery patients with or without haloperidol prophylaxis.
METHODS


Older patients with a postoperative delirium following hip surgery from a randomized controlled trial investigating the effects of haloperidol prophylaxis on delirium incidence were included in this study. The ACB was quantified using two different tools, the Anticholinergic Drug Scale and an Expert Panel. Using linear regression, the association between the ACB and delirium was analyzed.
RESULTS


Overall delirium duration and severity were not significantly associated with the ACB. Also, no statistically significant differences were found in delirium duration or severity between the placebo and haloperidol treatment groups for the ACB groups. The protective effect of haloperidol on delirium duration and severity however tended to be present in patients with no or a low ACB but not or to a lesser extent in patients with an intermediate to high ACB.
CONCLUSIONS


The ACB was not significantly associated with delirium duration or severity. Haloperidol prophylaxis tended to shorten delirium duration and decrease delirium severity in patients with no or a low ACB. To further explore the influence of anticholinergic acting drugs on delirium duration and severity and the effect of concomitant haloperidol use, additional research with a higher haloperidol dose, a larger study population, and ACB quantification taking drug exposure into account is warranted.",2021,"Also, no statistically significant differences were found in delirium duration or severity between the placebo and haloperidol treatment groups for the ACB groups.","['older patients', 'patients with no or a low ACB', 'older hip-surgery patients with and without', 'Older patients with a postoperative delirium following hip surgery', 'older hip-surgery patients with or without haloperidol prophylaxis', 'patients with no or a low ACB but not or to a lesser extent in patients with an intermediate to high ACB']","['anticholinergic acting drugs', 'haloperidol', 'haloperidol prophylaxis', 'Haloperidol prophylaxis', 'placebo']","['delirium duration', 'delirium severity', 'duration and severity of delirium', 'Overall delirium duration and severity', 'delirium incidence', 'delirium duration or severity', 'delirium duration and severity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0322608,"Also, no statistically significant differences were found in delirium duration or severity between the placebo and haloperidol treatment groups for the ACB groups.","[{'ForeName': 'Monique P H', 'Initials': 'MPH', 'LastName': 'Tillemans', 'Affiliation': 'Stichting Apotheek der Haarlemse ziekenhuizen, Haarlem, The Netherlands.'}, {'ForeName': 'Madelon H', 'Initials': 'MH', 'LastName': 'Butterhoff-Terlingen', 'Affiliation': 'Department of Clinical Pharmacy, Ter Gooi Ziekenhuizen, Hilversum, The Netherlands.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Stuffken', 'Affiliation': 'Department of Clinical Pharmacy, Ter Gooi Ziekenhuizen, Hilversum, The Netherlands.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Vreeswijk', 'Affiliation': 'Department of Geriatric Medicine, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'Toine C G', 'Initials': 'TCG', 'LastName': 'Egberts', 'Affiliation': 'Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Kees J', 'Initials': 'KJ', 'LastName': 'Kalisvaart', 'Affiliation': 'Department of Geriatric Medicine, Spaarne Gasthuis, Haarlem, The Netherlands.'}]",Brain and behavior,['10.1002/brb3.2404']
2693,34758408,Does the use of infrared technology (AccuVein AV-500®) for Peripheral Intravenous Cannulation (PIVC) increase the success rate in nursing students? A randomized controlled trial.,"BACKGROUND


PIVC is one of the essential procedures of modern medicine, and is one of the most widely used and important treatments in the clinical setting. Nevertheless, it is one of the most difficult skills to teach in nursing education, and it is the skill which causes the most anxiety in nursing students.
OBJECTIVES


The aim of the study was to examine the effect of the teaching method using infrared technology on PIVC success, duration, and the level of psychomotor skills and knowledge in the acquisition of PIVC skills in nursing students.
METHODS


This was a pre-test post-test randomized experimental study with a control group. The research was conducted in the Skills and Simulation Laboratory of a Nursing Faculty of a university between December 2019 and February 2020 to examine the effects of teaching PIVC measurement via infrared light on students' success rate. A theory lesson on PIVC followed 15 days later by laboratory practical was carried out with all of the students included in the study. The PIVC Knowledge Evaluation Form as a pre-test. The researchers completed the PIVC Skills Performance Test from observation during the application of the checklist. Immediately after the procedure, the PIVC Knowledge Evaluation Form was applied as a post-test.
RESULTS


The procedure success rate of the experimental group was 90%, and that of the control group was 46%. Comparing PIVC skill scores between the groups, the difference was found to be statistically significant (Z = -2.741; p < 0.05). The groups' PIVC knowledge levels increased in a similar way.
CONCLUSION


Teaching with infrared technology contributes more to students' success in PIVC skills than does standard teaching. Both methods were effective in developing knowledge of PIVC.",2021,"Comparing PIVC skill scores between the groups, the difference was found to be statistically significant (Z = -2.741; p < 0.05).","['nursing students', 'Nursing Faculty of a university between December 2019 and February 2020']","['teaching PIVC measurement via infrared light', 'infrared technology (AccuVein AV-500®']","['PIVC success, duration, and the level of psychomotor skills and knowledge in the acquisition of PIVC skills', 'PIVC skill scores', 'PIVC knowledge levels', 'knowledge of PIVC', 'procedure success rate']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0015538', 'cui_str': 'Nurse teacher'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.0156385,"Comparing PIVC skill scores between the groups, the difference was found to be statistically significant (Z = -2.741; p < 0.05).","[{'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Yılmaz', 'Affiliation': 'Bursa Uludağ University, Faculty of Medicine, Department of General Surgery, Turkey. Electronic address: hlyylmz2017@gmail.com.'}, {'ForeName': 'Şebnem Çınar', 'Initials': 'ŞÇ', 'LastName': 'Yücel', 'Affiliation': 'Ege University, Nursing Faculty, Department of Nursing, Izmir, Turkey.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Ergin', 'Affiliation': 'Izmir Bakircay University, Faculty of Health Sciences, Department of Nursing, İzmir, Turkey.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Bağcı', 'Affiliation': 'Dokuz Eylül University, Department of Chest Diseases, Izmir, Turkey.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Khorshid', 'Affiliation': 'Ege University, Nursing Faculty, Department of Nursing, Izmir, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2021.105179']
2694,34758385,Impact of precoding on reimbursement in diagnosis-related group systems: Randomized controlled trial.,"BACKGROUND


Complete and correct documentation of diagnosis and procedures is essential for adequate health provider reimbursement in diagnosis-related group (DRG) systems. The objective of this study was to investigate whether daily monitoring and semiautomated proposal optimization of DRG coding (precoding) is associated with higher reimbursement per hospitalization day.
MATERIALS AND METHODS


This parallel-group, unblinded, randomized clinical trial randomized patients 1:1 into intervention (precoding) and control groups. Between June 12 and December 6, 2019 all hospitalized patients (1566 cases) undergoing elective or emergency surgery at the department of surgery in a Swiss hospital were eligible for this study. By random sample selection, cases were assigned to the intervention (precoding) and control groups. The primary outcome was the total reimbursement, divided by the length of stay.
RESULTS


Of the 1205 randomized cases, 1200 (precoding group: 602) remained for intention-to-treat, and 1131 (precoding group: 564) for per-protocol analysis. Precoding increased reimbursement per hospitalization day by 6.5% (160 US dollars; 95% confidence interval 31 to 289; P = 0.015). In a regression analysis patients hospitalized 7 days or longer, precoding increased reimbursement per day by 10.0% (246 US dollars; 95% confidence interval -12 to 504; P = 0.021). More secondary diagnoses (mean [SD]: 5.16 [5.60] vs 4.39 [5.34]; 0.77; 95% confidence interval 0.15 to 1.39; P = 0.015) and nonsurgical postoperative complications (mean [SD]: 0.68 [1.45] vs 0.45 [1.12]; 0.23; 95% confidence interval 0.08 to 0.38; P = 0.002) were documented by precoding. No associated was observed regarding the length of stay, total reimbursement, or case mix index. The mean (SD) precoding time effort was 37 (27) minutes per case.
CONCLUSION


Physician-led precoding increases DRG-based reimbursement. Precoding is time consuming and should be focused on cases with a longer hospital stay to increase efficiency.",2021,Precoding increased reimbursement per hospitalization day by 6.5% (160 US dollars; 95% confidence interval 31 to 289; P = 0.015).,"['Of the 1205 randomized cases, 1200 (precoding group: 602) remained for intention-to-treat, and 1131 (precoding group: 564) for per-protocol analysis', 'diagnosis-related group systems', 'Between June 12 and December 6, 2019 all hospitalized patients (1566 cases) undergoing elective or emergency surgery at the department of surgery in a Swiss hospital were eligible for this study']",[],"['nonsurgical postoperative complications', 'total reimbursement, divided by the length of stay', 'length of stay, total reimbursement, or case mix index']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011928', 'cui_str': 'DRG'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0007319', 'cui_str': 'Case Mixes'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.334571,Precoding increased reimbursement per hospitalization day by 6.5% (160 US dollars; 95% confidence interval 31 to 289; P = 0.015).,"[{'ForeName': 'Ignazio', 'Initials': 'I', 'LastName': 'Tarantino', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplant Surgery, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Widmann', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplant Surgery, Kantonsspital St. Gallen, St. Gallen, Switzerland. Electronic address: bernhard.widmann@kssg.ch.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Warschkow', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplant Surgery, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weitzendorfer', 'Affiliation': 'Department of Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Bock', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplant Surgery, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Roeske', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplant Surgery, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Abbassi', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplant Surgery, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Rosita', 'Initials': 'R', 'LastName': 'Sortino', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplant Surgery, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Schmied', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplant Surgery, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Steffen', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplant Surgery, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106173']
2695,34758808,High intensity interval training versus moderate intensity continuous training for people with interstitial lung disease: protocol for a randomised controlled trial.,"BACKGROUND


Interstitial lung disease is a debilitating condition associated with significant dyspnoea, fatigue, and poor exercise tolerance. Pulmonary rehabilitation is an effective and key intervention in people with interstitial lung disease. However, despite the best efforts of patients and clinicians, many of those who participate are not achieving clinically meaningful benefits. This assessor-blinded, multi-centre, randomised controlled trial aims to compare the clinical benefits of high intensity interval exercise training versus the standard pulmonary rehabilitation method of continuous training at moderate intensity in people with fibrotic interstitial lung disease.
METHODS


Eligible participants will be randomised to either a standard pulmonary rehabilitation group using moderate intensity continuous exercise training or high intensity interval exercise training. Participants in both groups will undertake an 8-week pulmonary rehabilitation program of twice-weekly supervised exercise training including aerobic (cycling) and strengthening exercises. In addition, participants in both groups will be prescribed a home exercise program. Outcomes will be assessed at baseline, upon completion of the intervention and at six months following the intervention by a blinded assessor. The primary outcome is endurance time on a constant work rate test. Secondary outcomes are functional capacity (6-min walk distance), health-related quality of life (Chronic Respiratory Disease Questionnaire (CRQ), St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I), breathlessness (Dyspnoea 12, Modified Medical Research Council Dyspnoea Scale), fatigue (fatigue severity scale), anxiety (Hospital Anxiety and Depression Scale), physical activity level (GeneActiv), skeletal muscle changes (ultrasonography) and completion and adherence to pulmonary rehabilitation.
DISCUSSION


The standard exercise training strategies used in pulmonary rehabilitation may not provide an optimal exercise training stimulus for people with interstitial lung disease. This study will determine whether high intensity interval training can produce equivalent or even superior changes in exercise performance and symptoms. If high intensity interval training proves effective, it will provide an exercise training strategy that can readily be implemented into clinical practice for people with interstitial lung disease. Trial registration ClinicalTrials.gov Registry (NCT03800914). Registered 11 January 2019, https://clinicaltrials.gov/ct2/show/NCT03800914 Australian New Zealand Clinical Trials Registry ACTRN12619000019101. Registered 9 January 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376050&isReview=true.",2021,The standard exercise training strategies used in pulmonary rehabilitation may not provide an optimal exercise training stimulus for people with interstitial lung disease.,"['people with interstitial lung disease', 'people with fibrotic interstitial lung disease', 'Eligible participants']","['high intensity interval exercise training', 'pulmonary rehabilitation program of twice-weekly supervised exercise training including aerobic (cycling) and strengthening exercises', 'standard pulmonary rehabilitation group using moderate intensity continuous exercise training or high intensity interval exercise training', 'high intensity interval training', 'High intensity interval training versus moderate intensity continuous training', 'home exercise program', 'Pulmonary rehabilitation', 'continuous training']","['endurance time on a constant work rate test', ""functional capacity (6-min walk distance), health-related quality of life (Chronic Respiratory Disease Questionnaire (CRQ), St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I), breathlessness (Dyspnoea 12, Modified Medical Research Council Dyspnoea Scale), fatigue (fatigue severity scale), anxiety (Hospital Anxiety and Depression Scale), physical activity level (GeneActiv), skeletal muscle changes (ultrasonography) and completion and adherence to pulmonary rehabilitation""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]",,0.0271854,The standard exercise training strategies used in pulmonary rehabilitation may not provide an optimal exercise training stimulus for people with interstitial lung disease.,"[{'ForeName': 'Leona M', 'Initials': 'LM', 'LastName': 'Dowman', 'Affiliation': 'Respiratory Research @ Alfred, Central Clinical School, Monash University, Melbourne, VIC, Australia. leona.dowman@monash.edu.'}, {'ForeName': 'Anthony K', 'Initials': 'AK', 'LastName': 'May', 'Affiliation': 'Respiratory Research @ Alfred, Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Hill', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, VIC, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Bondarenko', 'Affiliation': 'Respiratory Research @ Alfred, Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Lissa', 'Initials': 'L', 'LastName': 'Spencer', 'Affiliation': 'Department of Physiotherapy, Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': 'School of Health Sciences and Social Work, The Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Alison', 'Affiliation': 'Allied Health Professorial Unit, Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Walsh', 'Affiliation': 'School of Health Sciences and Social Work, The Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Nicole S L', 'Initials': 'NSL', 'LastName': 'Goh', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, VIC, Australia.'}, {'ForeName': 'Tamera', 'Initials': 'T', 'LastName': 'Corte', 'Affiliation': 'Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Glaspole', 'Affiliation': 'Department of Respiratory Medicine, Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Chambers', 'Affiliation': 'NHMRC Centre of Research Excellence in Pulmonary Fibrosis, Sydney, NSW, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, VIC, Australia.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'Respiratory Research @ Alfred, Central Clinical School, Monash University, Melbourne, VIC, Australia.'}]",BMC pulmonary medicine,['10.1186/s12890-021-01704-2']
2696,34758807,Implications of remote monitoring Technology in Optimizing Traditional Self-Monitoring of blood glucose in adults with T2DM in primary care.,"BACKGROUND


Self-monitoring of blood glucose (SMBG) has been shown to reduce hemoglobin A1C (HbA1C). Accordingly, guidelines recommend SMBG up to 4-10 times daily for adults with type 2 diabetes (T2DM) on insulin. For persons not on insulin, recommendations are equivocal. Newer technology-enabled blood glucose monitoring (BGM) devices can facilitate remote monitoring of glycemic data. New evidence generated by remote BGM may help to guide best practices for frequency and timing of finger-stick blood glucose (FSBG) monitoring in uncontrolled T2DM patients managed in primary care settings. This study aims to evaluate the impact of SMBG utility and frequency on glycemic outcomes using a novel BGM system which auto-transfers near real-time FSBG data to a cloud-based dashboard using cellular networks.
METHODS


Secondary analysis of the intervention arm of a comparative non-randomized trial with propensity-matched chart controls. Adults with T2DM and HbA1C > 9% receiving care in five primary care practices in a healthcare system participated in a 3-month diabetes boot camp (DBC) using telemedicine and a novel BGM to support comprehensive diabetes care management. The primary independent variable was frequency of FSBG. Secondary outcomes included frequency of FSBG by insulin status, distribution of FSBG checks by time of day, and hypoglycemia rates.
RESULTS


48,111 FSBGs were transmitted by 359 DBC completers. Participants performed 1.5 FSBG checks/day; with 1.6 checks/day for those on basal/bolus insulin. Higher FSBG frequency was associated with greater improvement in HbA1C independent of insulin treatment status (p = 0.0003). FSBG frequency was higher in patients treated with insulin (p = 0.003). FSBG checks were most common pre-breakfast and post-dinner. Hypoglycemia was rare (1.2% < 70 mg/dL).
CONCLUSIONS


Adults with uncontrolled T2DM achieved significant HbA1C improvement performing just 1.5 FSBGs daily during a technology-enabled diabetes care intervention. Among the 40% taking insulin, this improvement was achieved with a lower FSBG frequency than guidelines recommend. For those not on insulin, despite a lower frequency of FSBG, they achieved a greater reduction in A1C compared to patients on insulin. Low frequency FSBG monitoring pre-breakfast and post-dinner can potentially support optimization of glycemic control regardless of insulin status in the primary care setting.
TRIAL REGISTRATION


Trial registration number: NCT02925312 (10/19/2016).",2021,"For those not on insulin, despite a lower frequency of FSBG, they achieved a greater reduction in A1C compared to patients on insulin.","['Adults with T2DM and HbA1C >\u20099% receiving care in five primary care practices in a healthcare system participated in a 3-month diabetes boot camp (DBC) using', 'adults with type 2 diabetes (T2DM) on insulin', 'adults with T2DM in primary care']","['blood glucose (SMBG', 'Newer technology-enabled blood glucose monitoring (BGM) devices', 'telemedicine and a novel BGM to support comprehensive diabetes care management']","['frequency of FSBG by insulin status, distribution of FSBG checks by time of day, and hypoglycemia rates', 'FSBG checks', 'hemoglobin A1C (HbA1C', 'Higher FSBG frequency', 'Hypoglycemia', 'frequency of FSBG', 'FSBG frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0457575', 'cui_str': 'Finger stick'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0439548', 'cui_str': 'Temporal periods of day'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205250', 'cui_str': 'High'}]",48111.0,0.0415752,"For those not on insulin, despite a lower frequency of FSBG, they achieved a greater reduction in A1C compared to patients on insulin.","[{'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Montero', 'Affiliation': 'Department of Medicine, MedStar Georgetown University Hospital, 3800 Reservoir Rd, Washington, DC, 20007, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Toro-Tobon', 'Affiliation': 'Mayo Clinic, Division of Endocrinology, 200 1st Street NW, Rochester, MN, 55905, USA. Torotobon.david@mayo.edu.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Gann', 'Affiliation': 'BioTelemetry, 1000 Cedar Hollow Road, Suite 102, Malvern, PA, 19355, USA.'}, {'ForeName': 'Carine M', 'Initials': 'CM', 'LastName': 'Nassar', 'Affiliation': 'MedStar Diabetes Institute, 100 Irving Street, NW # 4114, Washington, DC, 20010, USA.'}, {'ForeName': 'Gretchen A', 'Initials': 'GA', 'LastName': 'Youssef', 'Affiliation': 'MedStar Diabetes Institute, 100 Irving Street, NW # 4114, Washington, DC, 20010, USA.'}, {'ForeName': 'Michelle F', 'Initials': 'MF', 'LastName': 'Magee', 'Affiliation': 'MedStar Diabetes Institute, 100 Irving Street, NW # 4114, Washington, DC, 20010, USA.'}]",BMC endocrine disorders,['10.1186/s12902-021-00884-6']
2697,34758798,The older prisoner health and social care assessment and plan (OHSCAP) versus treatment as usual: a randomised controlled trial.,"BACKGROUND


Older people are the fastest-growing demographic group among prisoners in England and Wales and they have complex health and social care needs. Their care is frequently ad hoc and uncoordinated. No previous research has explored how to identify and appropriately address the needs of older adults in prison. We hypothesised that the Older prisoner Health and Social Care Assessment and Plan (OHSCAP) would significantly increase the proportion of met health and social care needs 3 months after prison entry, compared to treatment as usual (TAU).
METHODS


The study was a parallel randomised controlled trial (RCT) recruiting male prisoners aged 50 and over from 10 prisons in northern England. Participants received the OHSCAP or TAU. A clinical trials unit used minimisation with a random element as the allocation procedure. Data analysis was conducted blind to allocation status. The intervention group had their needs assessed using the OHSCAP tool and care plans were devised; processes that lasted approximately 30 min in total per prisoner. TAU included the standard prison health assessment and care. The intention to treat principle was followed. The trial was registered with the UK Clinical Research Network Portfolio (ISRCTN ID: 11841493) and was closed on 30 November 2016.
RESULTS


Data were collected between 28 January 2014 and 06 April 2016. Two hundred and forty nine older prisoners were assigned TAU of which 32 transferred prison; 12 were released; 2 withdrew and 1 was deemed unsafe to interview. Two hundred and fifty three 3 prisoners were assigned the OHSCAP of which 33 transferred prison; 11 were released; 6 withdrew and 1 was deemed unsafe to interview. Consequently, data from 202 participants were analysed in each of the two groups. There were no significant differences in the number of unmet needs as measured by the Camberwell Assessment of Needs - Forensic Short Version (CANFOR-S). The mean number of unmet needs for the OHSCAP group at follow-up was 2.03 (SD = 2.07) and 2.06 (SD = 2.11) for the TAU group (mean difference = 0.088; 95% CI - 0.276 to 0.449, p = 0.621). No adverse events were reported.
CONCLUSION


The OHSCAP was fundamentally not implemented as planned, partly due to the national prison staffing crisis that ensued during the study period. Therefore, those receiving the OHSCAP did not experience improved outcomes compared to those who received TAU.
TRIAL REGISTRATION


Current Controlled Trials: ISRCTN11841493 , 25/10/2012.",2021,There were no significant differences in the number of unmet needs as measured by the Camberwell Assessment of Needs - Forensic Short Version (CANFOR-S).,"['male prisoners aged 50 and over from 10 prisons in northern England', 'Two hundred and forty nine older prisoners were assigned TAU of which 32 transferred prison; 12 were released; 2 withdrew and 1 was deemed unsafe to interview', 'Data were collected between 28 January 2014 and 06 April 2016', 'Older people', '202 participants', 'older adults in prison', 'Two hundred and fifty three 3 prisoners were assigned the OHSCAP of which 33 transferred prison; 11 were released; 6 withdrew and 1 was deemed unsafe to interview']","['OHSCAP', 'social care assessment and plan (OHSCAP', 'OHSCAP or TAU']","['mean number of unmet needs', 'number of unmet needs as measured by the Camberwell Assessment of Needs - Forensic Short Version (CANFOR-S', 'adverse events']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0558005', 'cui_str': 'Assessment of needs'}, {'cui': 'C0016557', 'cui_str': 'Medicine, Forensic'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",202.0,0.324605,There were no significant differences in the number of unmet needs as measured by the Camberwell Assessment of Needs - Forensic Short Version (CANFOR-S).,"[{'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Forsyth', 'Affiliation': 'The University of Manchester, Oxford Road, Manchester, M13 9PL, UK. Katrina.Forsyth@manchester.ac.uk.'}, {'ForeName': 'Roger T', 'Initials': 'RT', 'LastName': 'Webb', 'Affiliation': 'The University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Laura Archer', 'Initials': 'LA', 'LastName': 'Power', 'Affiliation': 'Lancashire Police, Saunders Lane, Hutton, PR4 5SB, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""King's College, London Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Senior', 'Affiliation': 'The University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'The University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': 'Institute of Mental Health, Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hayes', 'Affiliation': 'Avon and Wiltshire Mental Health Partnership NHS Trust, Bath NHS House, Newbridge Hill, Bath, BA1 3QE, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Meacock', 'Affiliation': 'The University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Walsh', 'Affiliation': 'Care UK, Hawker House, 5-6 Napier Court, Napier Road, Reading, Berkshire, RG1 8BW, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Ware', 'Affiliation': 'Restore Support Network, Exeter CVS, Wat Tyler House, King William Street, Exeter, EX4 6PD, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': 'The University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}]",BMC public health,['10.1186/s12889-021-11965-5']
2698,34758761,"Effectiveness of mobile application on changing weight, healthy eating habits, and quality of life in children and adolescents with obesity: a randomized controlled trial.","BACKGROUND


A technology-based intervention, such as a mobile application, was a growing interest and potentially effective modality for treating obesity. The study aimed to evaluate the effectiveness of the OBEST, a new mobile/tablet-based application in reducing weight and encouraging healthy eating behaviors and quality of life in children with obesity. The application could assist healthcare professionals to treat children and adolescents with obesity.
METHODS


A randomized controlled trial was conducted in the hospital and school settings in Chiang Mai, Thailand. Seventy-seven children and adolescents with obesity were randomized into two groups; one received standard care combined with the OBEST application, and the other received only standard care. The outcomes were changes in weight, healthy eating behaviors, and quality of life assessed by the Pediatric Quality of Life Inventory (PedsQL) from baseline to six-month follow-up between the two groups.
RESULTS


The results showed that the intervention group reduced more body mass index (BMI) and had a higher number of participants engaging in healthy eating behaviors than the standard care group but did not reach a statistically significant level, except for less frequent consumption of fast food. The participants in the intervention group had 4.5 times higher odds of decreased engaging in fast-food consumption than the standard care group at 6 months follow-up (odds ratio, 4.5 [95% CI, 1.41 to 14.35]). There were no statistically significant changes in PedsQL scores over 6 months in between groups.
CONCLUSIONS


The current study was unable to detect a significant effect of the OBEST application as an adjunct tool to the standard treatment on reducing weight in obese children and adolescents. However, the mobile application might help to increase engaging in healthy eating behaviors. Further studies with a larger sample are needed to confirm our findings.
TRIAL REGISTRATION


The trial was retrospectively registered at the Thai Clinical Trials Registry (trial registration number: TCTR20200604008 , on June 4, 2020).",2021,"The outcomes were changes in weight, healthy eating behaviors, and quality of life assessed by the Pediatric Quality of Life Inventory (PedsQL) from baseline to six-month follow-up between the two groups.
","['children and adolescents with obesity', 'obese children and adolescents', 'Seventy-seven children and adolescents with obesity', 'hospital and school settings in Chiang Mai, Thailand', 'children with obesity']","['standard care combined with the OBEST application, and the other received only standard care', 'mobile application', 'OBEST application', 'OBEST']","['times higher odds of decreased engaging in fast-food consumption', 'body mass index (BMI', 'changing weight, healthy eating habits, and quality of life', 'healthy eating behaviors and quality of life', 'PedsQL scores', 'frequent consumption of fast food', 'changes in weight, healthy eating behaviors, and quality of life assessed by the Pediatric Quality of Life Inventory (PedsQL', 'healthy eating behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",77.0,0.0846576,"The outcomes were changes in weight, healthy eating behaviors, and quality of life assessed by the Pediatric Quality of Life Inventory (PedsQL) from baseline to six-month follow-up between the two groups.
","[{'ForeName': 'Narueporn', 'Initials': 'N', 'LastName': 'Likhitweerawong', 'Affiliation': 'Division of Growth and Development, Department of Pediatrics, Faculty of Medicine, Chiang Mai University, 110 Inthawarorot Road, Sriphum, Muang, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Nonglak', 'Initials': 'N', 'LastName': 'Boonchooduang', 'Affiliation': 'Division of Growth and Development, Department of Pediatrics, Faculty of Medicine, Chiang Mai University, 110 Inthawarorot Road, Sriphum, Muang, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Kulnipa', 'Initials': 'K', 'LastName': 'Kittisakmontri', 'Affiliation': 'Division of Pediatric Nutrition, Department of Pediatrics, Faculty of Medicine, Chiang Mai University, 110 Inthawarorot Road, Sriphum, Muang, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Weerasak', 'Initials': 'W', 'LastName': 'Chonchaiya', 'Affiliation': ""Maximizing Thai Children's Developmental Potential Research Unit, Division of Growth and Development, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 Road, Pathumwan, Bangkok, 10330, Thailand.""}, {'ForeName': 'Orawan', 'Initials': 'O', 'LastName': 'Louthrenoo', 'Affiliation': 'Division of Growth and Development, Department of Pediatrics, Faculty of Medicine, Chiang Mai University, 110 Inthawarorot Road, Sriphum, Muang, Chiang Mai, 50200, Thailand. orawan.l@cmu.ac.th.'}]",BMC pediatrics,['10.1186/s12887-021-02980-x']
2699,34758759,"Effects of two 24-week multimodal exercise programs on reaction time, mobility, and dual-task performance in community-dwelling older adults at risk of falling: a randomized controlled trial.","BACKGROUND


Falls in older adults are considered a major public health problem. Declines in cognitive and physical functions, as measured by parameters including reaction time, mobility, and dual-task performance, have been reported to be important risk factors for falls. The aim of this study was to investigate the effects of two multimodal programs on reaction time, mobility, and dual-task performance in community-dwelling older adults at risk of falling.
METHODS


In this randomized controlled trial, fifty-one participants (75.4 ± 5.6 years) were allocated into two experimental groups (EGs) (with sessions 3 times per week for 24 weeks), and a control group: EG1 was enrolled in a psychomotor intervention program, EG2 was enrolled in a combined exercise program (psychomotor intervention program + whole-body vibration program), and the control group maintained their usual daily activities. The participants were assessed at baseline, after the intervention, and after a 12-week no-intervention follow-up period.
RESULTS


The comparisons revealed significant improvements in mobility and dual-task performance after the intervention in EG1, while there were improvements in reaction time, mobility, and dual-task performance in EG2 (p ≤ 0.05). The size of the interventions' clinical effect was medium in EG1 and ranged from medium to large in EG2. The comparisons also showed a reduction in the fall rate in both EGs (EG1: -44.2%; EG2: - 63.0%, p ≤ 0.05) from baseline to post-intervention. The interventions' effects on reaction time, mobility, and dual-task performance were no longer evident after the 12-week no-intervention follow-up period.
CONCLUSIONS


The results suggest that multimodal psychomotor programs were well tolerated by community-dwelling older adults and were effective for fall prevention, as well as for the prevention of cognitive and physical functional decline, particularly if the programs are combined with whole-body vibration exercise. The discontinuation of these programs could lead to the fast reversal of the positive outcomes achieved.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03446352. Date of registration: February 07, 2018.",2021,"The interventions' effects on reaction time, mobility, and dual-task performance were no longer evident after the 12-week no-intervention follow-up period.
","['older adults', 'community-dwelling older adults at risk of falling', 'fifty-one participants (75.4\u2009±\u20095.6\u2009years']","['psychomotor intervention program, EG2 was enrolled in a combined exercise program (psychomotor intervention program + whole-body vibration program), and the control group maintained their usual daily activities', 'multimodal exercise programs']","['mobility and dual-task performance', 'reaction time, mobility, and dual-task performance', 'reaction time, mobility, and dual-task performance in EG2', 'fall rate', 'cognitive and physical functions']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",51.0,0.028616,"The interventions' effects on reaction time, mobility, and dual-task performance were no longer evident after the 12-week no-intervention follow-up period.
","[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Rosado', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, Largo dos Colegiais 2, Évora, Portugal. hrosado@uevora.pt.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Bravo', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, Largo dos Colegiais 2, Évora, Portugal.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Raimundo', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, Largo dos Colegiais 2, Évora, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Carvalho', 'Affiliation': 'Faculdade de Desporto, Universidade do Porto, Praça de Gomes Teixeira, Porto, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Marmeleira', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, Largo dos Colegiais 2, Évora, Portugal.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Pereira', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, Largo dos Colegiais 2, Évora, Portugal.'}]",BMC public health,['10.1186/s12889-021-10448-x']
2700,34758737,Evaluation of implementation and effectiveness of digital adherence technology with differentiated care to support tuberculosis treatment adherence and improve treatment outcomes in Ethiopia: a study protocol for a cluster randomised trial.,"BACKGROUND


Digital adherence technologies (DATs) are recommended to support patient-centred, differentiated care to improve tuberculosis (TB) treatment outcomes, but evidence that such technologies improve adherence is limited. We aim to implement and evaluate the effectiveness of smart pillboxes and medication labels linked to an adherence data platform, to create a differentiated care response to patient adherence and improve TB care among adult pulmonary TB participants. Our study is part of the Adherence Support Coalition to End TB (ASCENT) project in Ethiopia.
METHODS/DESIGN


We will conduct a pragmatic three-arm cluster-randomised trial with 78 health facilities in two regions in Ethiopia. Facilities are randomised (1:1:1) to either of the two intervention arms or standard of care. Adults aged ≥ 18 years with drug-sensitive (DS) pulmonary TB are enrolled over 12 months and followed-up for 12 months after treatment initiation. Participants in facilities randomised to either of the two intervention arms are offered a DAT linked to the web-based ASCENT adherence platform for daily adherence monitoring and differentiated response to patient adherence for those who have missed doses. Participants at standard of care facilities receive routine care. For those that had bacteriologically confirmed TB at treatment initiation and can produce sputum without induction, sputum culture will be performed approximately 6 months after the end of treatment to measure disease recurrence. The primary endpoint is a composite unfavourable outcome measured over 12 months from TB treatment initiation defined as either poor end of treatment outcome (lost to follow-up, death, or treatment failure) or treatment recurrence measured 6 months after the scheduled end of treatment. This study will also evaluate the effectiveness, feasibility, and cost-effectiveness of DAT systems for DS-TB patients.
DISCUSSION


This trial will evaluate the impact and contextual factors of medication label and smart pillbox with a differentiated response to patient care, among adult pulmonary DS-TB participants in Ethiopia. If successful, this evaluation will generate valuable evidence via a shared evaluation framework for optimal use and scale-up.
TRIAL REGISTRATION


Pan African Clinical Trials Registry PACTR202008776694999, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241 , registered on August 11, 2020.",2021,Participants in facilities randomised to either of the two intervention arms are offered a DAT linked to the web-based ASCENT adherence platform for daily adherence monitoring and differentiated response to patient adherence for those who have missed doses.,"['Ethiopia', 'DS-TB patients', 'Adults aged\u2009≥', '78 health facilities in two regions in Ethiopia', '18\xa0years with drug-sensitive (DS) pulmonary TB are enrolled over 12\xa0months and followed-up for 12\xa0months after treatment initiation', 'adult pulmonary TB participants', 'adult pulmonary DS-TB participants in Ethiopia', 'Participants at standard of care facilities receive routine care']","['smart pillboxes and medication labels', 'digital adherence technology with differentiated care to support tuberculosis treatment adherence', 'DAT linked to the web-based ASCENT adherence platform']","['composite unfavourable outcome measured over 12\xa0months from TB treatment initiation defined as either poor end of treatment outcome (lost to follow-up, death, or treatment failure) or treatment recurrence']","[{'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.150024,Participants in facilities randomised to either of the two intervention arms are offered a DAT linked to the web-based ASCENT adherence platform for daily adherence monitoring and differentiated response to patient adherence for those who have missed doses.,"[{'ForeName': 'Amare W', 'Initials': 'AW', 'LastName': 'Tadesse', 'Affiliation': 'TB Centre, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM), London, UK. amare.tadesse@lshtm.ac.uk.'}, {'ForeName': 'Zemedu', 'Initials': 'Z', 'LastName': 'Mohammed', 'Affiliation': 'KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Foster', 'Affiliation': 'TB Modelling Group, TB Centre, and Centre for Mathematical Modelling of Infectious Diseases, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Quaife', 'Affiliation': 'TB Modelling Group, TB Centre, and Centre for Mathematical Modelling of Infectious Diseases, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'Christopher Finn', 'Initials': 'CF', 'LastName': 'McQuaid', 'Affiliation': 'TB Modelling Group, TB Centre, and Centre for Mathematical Modelling of Infectious Diseases, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'KNCV Tuberculosis Foundation, The Hague, the Netherlands.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'van Kalmthout', 'Affiliation': 'KNCV Tuberculosis Foundation, The Hague, the Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van Rest', 'Affiliation': 'KNCV Tuberculosis Foundation, The Hague, the Netherlands.'}, {'ForeName': 'Degu', 'Initials': 'D', 'LastName': 'Jerene', 'Affiliation': 'KNCV Tuberculosis Foundation, The Hague, the Netherlands.'}, {'ForeName': 'Tofik', 'Initials': 'T', 'LastName': 'Abdurhman', 'Affiliation': 'KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia.'}, {'ForeName': 'Hiwot', 'Initials': 'H', 'LastName': 'Yazew', 'Affiliation': 'KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia.'}, {'ForeName': 'Demekech G', 'Initials': 'DG', 'LastName': 'Umeta', 'Affiliation': 'KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia.'}, {'ForeName': 'Demelash', 'Initials': 'D', 'LastName': 'Assefa', 'Affiliation': 'KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia.'}, {'ForeName': 'Gedion T', 'Initials': 'GT', 'LastName': 'Weldemichael', 'Affiliation': 'KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Bedru', 'Affiliation': 'KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia.'}, {'ForeName': 'Taye', 'Initials': 'T', 'LastName': 'Letta', 'Affiliation': 'National Tuberculosis Control Program, Ethiopian Ministry of Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Fielding', 'Affiliation': 'TB Centre, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM), London, UK.'}]",BMC infectious diseases,['10.1186/s12879-021-06833-x']
2701,34758731,Association of fibroblast growth factor 23 and α-klotho in hemodialysis patients during administration of ferric citrate hydrate: post hoc analysis of ASTRIO study.,"BACKGROUND


Fibroblast growth factor-23 (FGF23) and α-klotho are associated with anemia in patients with chronic kidney disease. In this post hoc analysis of the ASTRIO study (UMIN000019176), we investigated the relationship between FGF23 and α-klotho during treatment with an iron-based phosphate binder, ferric citrate hydrate (FC), compared with non-iron-based phosphate binders in hemodialysis (HD) patients. We examined the effect of iron absorption by FC on the relationship between FGF23 and α-klotho. There have been few clinical studies evaluating these biomarkers simultaneously in HD patients.
METHODS


The ASTRIO study was a 24-week, randomized, open-label, multicenter trial. HD patients taking non-iron-based phosphate binder(s) were randomized at a 1:1 ratio to continue other binder(s) (control group) or switch to FC (FC group). Serum phosphate (P) and hemoglobin (Hb) were maintained within 3.5-6.0 mg/dL and 10-12 g/dL, respectively. Plasma levels of intact FGF23 (i-FGF23), C-terminal FGF23 (c-FGF23), and α-klotho were measured, as were iron-related parameters. Association analyses of FGF23 and α-klotho were conducted.
RESULTS


Patients were randomized to FC (n = 48) and control (n = 45) groups. Serum ferritin significantly increased from baseline to end-of-treatment (EOT) in the FC group, compared with the control group (adjusted mean difference [95% confidence interval]: 79.5 [44.7, 114.4] ng/mL; p <  0.001). The mean change from baseline to EOT in c-FGF23 was significantly different between the FC and control groups (mean ± standard deviation (SD): - 0.2 ± 0.8 log e  pg/mL vs. 0.2 ± 0.8 log e  pg/mL, respectively; p = 0.04). The mean change from baseline to EOT in i-FGF23 and α-klotho were not significantly different between the FC and control groups (mean ± SD: - 0.1 ± 0.8 log e  pg/mL vs. 0.1 ± 0.9 log e  pg/mL; p = 0.33, and 2.0 ± 91.5 pg/mL vs. - 8.9 ± 145.3; p = 0.58, respectively). However, both forms of FGF23 and α-klotho were not significantly associated with each other in both groups.
CONCLUSIONS


Iron absorbed via FC administration in HD patients did not influence the correlation relationship between plasma levels of FGF23 and α-klotho under the condition of serum P and Hb were maintained.
TRIAL REGISTRATION


ASTRIO study ( UMIN000019176 , registered at UMIN Clinical Trials Registry on October 1, 2015).",2021,The mean change from baseline to EOT in i-FGF23 and α-klotho were not significantly different between the FC and control groups (mean ± SD: - 0.1 ± ,"['hemodialysis patients', 'patients with chronic kidney disease', 'HD patients', 'in hemodialysis (HD) patients', 'HD patients taking non-iron-based phosphate binder(s']","['iron-based phosphate binder, ferric citrate hydrate (FC), compared with non-iron-based phosphate binders', 'fibroblast growth factor 23 and α-klotho', 'ferric citrate hydrate', 'FC']","['Serum phosphate (P) and hemoglobin (Hb', 'Serum ferritin', 'Plasma levels of intact FGF23 (i-FGF23), C-terminal FGF23 (c-FGF23), and α-klotho']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}]","[{'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0060231', 'cui_str': 'ferric citrate'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}]","[{'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C1829744', 'cui_str': 'Fibroblast growth factor 23, C-terminal'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}]",,0.0622777,The mean change from baseline to EOT in i-FGF23 and α-klotho were not significantly different between the FC and control groups (mean ± SD: - 0.1 ± ,"[{'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Medical Affairs Department, Torii Pharmaceutical Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Keitaro', 'Initials': 'K', 'LastName': 'Yokoyama', 'Affiliation': 'Health Care Center, Harumi Toriton Clinic, The Jikei University Hospital, 1-8-8 Harumi, Chuo-ku, Tokyo, 104-0053, Japan. keitaro@jikei.ac.jp.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': ""St. Luke's International University, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Fukagawa', 'Affiliation': 'Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hirakata', 'Affiliation': 'Fukuoka Renal Clinic, Fukuoka, Japan.'}]",BMC nephrology,['10.1186/s12882-021-02575-9']
2702,34758698,A Pilot Study Assessing Reactions to Educational Videos on Harm of Waterpipe among Young Adults Susceptible to Waterpipe Tobacco Smoking.,"Young adults who never engaged in waterpipe tobacco smoking (WTS) yet are open to trying it, that is, are susceptible, is a high-risk group for initiation WTS. Very few interventions dissuade this group from WTS. Thus, we explored how four short videos that varied themes of WTS harms influenced susceptible young adults' risk perceptions, risk beliefs, and susceptibility to future WTS. As part of online cross-sectional study, 208 participants aged 18-34 were randomized to watch or not a short video; each video focused on different themes of WTS risks: physical harms, myths about WTS, addiction, and harms to others. The main outcomes were perceived personal risks, risk beliefs, perceived harm of WTS compared to cigarettes, and susceptibility to future WTS. Watching any video increased beliefs of harm of WTS and lowered susceptibility to future WTS compared to not watching a video. The theme of physical harms was most effective at increasing risk beliefs and lowering susceptibility to future WTS. All four videos were rated as credible, engaging, personally relevant, producing negative affect toward WTS, and effective at dissuading WTS. These promising findings suggest further testing is needed to determine if effects persist and prevent WTS among adults susceptible to WTS.",2021,Watching any video increased beliefs of harm of WTS and lowered susceptibility to future WTS compared to not watching a video.,"['Young adults who never engaged in waterpipe tobacco smoking (WTS', '208 participants aged 18-34', 'Young Adults Susceptible to Waterpipe Tobacco Smoking']",['Educational Videos'],"['personal risks, risk beliefs, perceived harm of WTS compared to cigarettes, and susceptibility to future WTS']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4505131', 'cui_str': 'Waterpipe Tobacco'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4505131', 'cui_str': 'Waterpipe Tobacco'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",208.0,0.0321597,Watching any video increased beliefs of harm of WTS and lowered susceptibility to future WTS compared to not watching a video.,"[{'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Lipkus', 'Affiliation': 'Duke University School of Nursing, Durham, North Carolina, USA.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Sanders', 'Affiliation': 'Duke University School of Nursing, Durham, North Carolina, USA.'}]",Journal of health communication,['10.1080/10810730.2021.2000522']
2703,34758661,Clinical Indoor Running Gait Analysis May Not Approximate Outdoor Running Gait Based on Novel Drone Technology.,"BACKGROUND


Traditional running gait analysis is limited to artificial environments, but whether treadmill running approximates overground running is debated. This study aimed to compare treadmill gait analysis using fixed video with outdoor gait analysis using drone video capture.
HYPOTHESIS


Measured kinematics would be similar between natural outdoor running and traditional treadmill gait analysis.
STUDY DESIGN


Crossover study.
LEVEL OF EVIDENCE


Level 2.
METHODS


The study population included cross-country, track and field, and recreational athletes with current running mileage of at least 15 km per week. Participants completed segments in indoor and outdoor environments. Indoor running was completed on a treadmill with static video capture, and outdoor segments were obtained via drone on an outdoor track. Three reviewers independently performed clinical gait analysis on footage for 32 runners using kinematic measurements with published acceptable intra- and interrater reliability.
RESULTS


Of the 8 kinematic variables measured, 2 were found to have moderate agreement indoor versus outdoor, while 6 had fair to poor agreement. Foot strike at initial contact and rearfoot position at midstance had moderate agreement indoor versus outdoor, with a kappa of 0.54 and 0.49, respectively. The remaining variables: tibial inclination at initial contact, knee flexion angle initial contact, forward trunk lean full gait cycle, knee center position midstance, knee separation midstance, and lateral pelvic drop at midstance were found to have fair to poor agreement, ranging from 0.21 to 0.36.
CONCLUSION


This study suggests that kinematics may differ between natural outdoor running and traditional treadmill gait analysis.
CLINICAL RELEVANCE


Providing recommendations for altering gait based on treadmill gait analysis may prove to be harmful if treadmill analysis does not approximate natural running environments. Drone technology could provide advancement in clinical running recommendations by capturing runners in natural environments.",2021,"Foot strike at initial contact and rearfoot position at midstance had moderate agreement indoor versus outdoor, with a kappa of 0.54 and 0.49, respectively.","['capturing runners in natural environments', 'The study population included cross-country, track and field, and recreational athletes with current running mileage of at least 15 km per week']",['fixed video with outdoor gait analysis using drone video capture'],"['tibial inclination at initial contact, knee flexion angle initial contact, forward trunk lean full gait cycle, knee center position midstance, knee separation midstance, and lateral pelvic drop at midstance']","[{'cui': 'C0557745', 'cui_str': 'Natural environment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0040595', 'cui_str': 'Track and field'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}]","[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]",,0.114767,"Foot strike at initial contact and rearfoot position at midstance had moderate agreement indoor versus outdoor, with a kappa of 0.54 and 0.49, respectively.","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Lafferty', 'Affiliation': 'Department of Family and Community Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wawrzyniak', 'Affiliation': 'Department of Physical Therapy, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Chambers', 'Affiliation': 'Department of Family and Community Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Pagliarulo', 'Affiliation': 'Independent Researcher.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Berg', 'Affiliation': 'Department of Public Health Sciences, Division of Biostatistics and Bioinformatics, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Hawila', 'Affiliation': 'Department of Public Health Sciences, Division of Biostatistics and Bioinformatics, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Silvis', 'Affiliation': 'Department of Family and Community Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}]",Sports health,['10.1177/19417381211050931']
2704,34758629,Experience of participants with chronic pain in a pilot randomized clinical trial using a ketogenic diet.,"Aim:  To report the experience of chronic pain participants after a well-formulated ketogenic diet (WFKD) or whole-food diet (WFD). The quantitative outcomes for this trial have been published separately (clinical trial registration number ACTRN12620000946910).  Patients & methods:  The experience of 24 participants was evaluated after 12 and 24 weeks of dietary intervention using survey responses and open questions.  Results & conclusion:  Retention rates for the WFKD and WFD groups were 93 and 89%, respectively. Average adherence to the WFKD was 82% and to the WFD was 87%. The WFKD enjoyment was rated at 66 and 81% for the WFD group. The ease of adhering to the diet varied more widely for the WFKD group. Barriers included knowledge integration, time management, navigating social food environments and emotional attachment to eliminated foods. Facilitators included structured support and coaching, and comprehensive learning materials. The WFKD was shown to be a feasible and effective treatment option for chronic pain.",2021,The WFKD enjoyment was rated at 66 and 81% for the WFD group.,"['participants with chronic pain', 'chronic pain participants after a', '24 participants was evaluated after 12 and 24 weeks of']","['well-formulated ketogenic diet (WFKD) or whole-food diet (WFD', 'dietary intervention', 'ketogenic diet', 'structured support and coaching, and comprehensive learning materials']","['knowledge integration, time management, navigating social food environments and emotional attachment to eliminated foods', 'Retention rates', 'Average adherence to the WFKD', 'WFKD enjoyment']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0453870', 'cui_str': 'Whole food'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",24.0,0.0895868,The WFKD enjoyment was rated at 66 and 81% for the WFD group.,"[{'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Field', 'Affiliation': 'Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Tara J', 'Initials': 'TJ', 'LastName': 'Field', 'Affiliation': 'The New South Wales Ministry of Health (NSW Health), Sydney, Australia.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Pourkazemi', 'Affiliation': 'Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kieron B', 'Initials': 'KB', 'LastName': 'Rooney', 'Affiliation': 'Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}]",Pain management,['10.2217/pmt-2021-0084']
2705,34759045,Effect of intraperitoneal local anesthesia on enhanced recovery outcomes after bariatric surgery: a randomized controlled pilot study.,"BACKGROUND


Patients with extreme obesity are at high risk for adverse perioperative events, especially when opioid-centric analgesic protocols are used, and perioperative pain management interventions in bariatric surgery could improve safety, outcomes and satisfaction. We aimed to evaluate the impact of intraperitoneal local anesthesia (IPLA) on enhanced recovery after bariatric surgery (ERABS) outcomes.
METHODS


We conducted a prospective double-blind randomized controlled pilot study in adherence to an a priori peer-reviewed protocol. Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery (LRYGB) with an established ERABS protocol between July 2014 and February 2015 were randomly allocated to receive either IPLA with 0.2% ropivacaine (intervention group) or normal saline (control group). We measured pain scores, analgesic consumption and adverse effects. Functional prehabilitation outcomes, including peak expiratory flow (PEF) and the Six Minute Walk Test (6MWT) and Quality of Recovery Survey-40 (QoR-40) scores, were assessed before surgery, and 1 day and 7 days postoperatively.
RESULTS


One hundred patients were randomly allocated to the study groups, of whom 92 completed the study, 46 in each group. There were no statistically significant differences between the 2 groups in baseline characteristics or any primary or secondary outcomes. Pain scores and analgesic consumption were low in both groups. There were no adverse events. Significant declines in PEF and 6MWT and QoR-40 scores were noted on postoperative day 1 in both groups; the values returned to baseline on postoperative day 7 in both groups.
CONCLUSION


Intraperitoneal local anesthesia with ropivacaine did not reduce postoperative pain or analgesic consumption when administered intraoperatively to patients undergoing LRYGB. Standardization of the ERABS protocol benefited patients, with functional prehabilitation outcomes returning to baseline postoperatively.  Trial registration:  ClinicalTrials.gov no. NCT02154763.",2021,"Significant declines in PEF and 6MWT and QoR-40 scores were noted on postoperative day 1 in both groups; the values returned to baseline on postoperative day 7 in both groups.
","['Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery (LRYGB) with an established ERABS protocol between July 2014 and February 2015', 'Patients with extreme obesity', 'bariatric surgery', 'One hundred patients were randomly allocated to the study groups, of whom 92 completed the study, 46 in each group']","['IPLA with 0.2% ropivacaine (intervention group) or normal saline (control group', 'intraperitoneal local anesthesia', 'ropivacaine', 'intraperitoneal local anesthesia (IPLA']","['Pain scores and analgesic consumption', 'PEF and 6MWT and QoR-40 scores', 'pain scores, analgesic consumption and adverse effects', 'postoperative pain or analgesic consumption', 'peak expiratory flow (PEF) and the Six Minute Walk Test (6MWT) and Quality of Recovery Survey-40 (QoR-40) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",100.0,0.549094,"Significant declines in PEF and 6MWT and QoR-40 scores were noted on postoperative day 1 in both groups; the values returned to baseline on postoperative day 7 in both groups.
","[{'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Jarrar', 'Affiliation': 'From the Department of Surgery, The Ottawa Hospital, Ottawa, Ont. (Jarrar, Wu, Neville, Yelle, Mamazza); and the Department of Anesthesiology, The Ottawa Hospital, Ottawa, Ont. (Eipe). ajarrar.md@gmail.com.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Eipe', 'Affiliation': 'From the Department of Surgery, The Ottawa Hospital, Ottawa, Ont. (Jarrar, Wu, Neville, Yelle, Mamazza); and the Department of Anesthesiology, The Ottawa Hospital, Ottawa, Ont. (Eipe).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'From the Department of Surgery, The Ottawa Hospital, Ottawa, Ont. (Jarrar, Wu, Neville, Yelle, Mamazza); and the Department of Anesthesiology, The Ottawa Hospital, Ottawa, Ont. (Eipe).'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Neville', 'Affiliation': 'From the Department of Surgery, The Ottawa Hospital, Ottawa, Ont. (Jarrar, Wu, Neville, Yelle, Mamazza); and the Department of Anesthesiology, The Ottawa Hospital, Ottawa, Ont. (Eipe).'}, {'ForeName': 'Jean-Denis', 'Initials': 'JD', 'LastName': 'Yelle', 'Affiliation': 'From the Department of Surgery, The Ottawa Hospital, Ottawa, Ont. (Jarrar, Wu, Neville, Yelle, Mamazza); and the Department of Anesthesiology, The Ottawa Hospital, Ottawa, Ont. (Eipe).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mamazza', 'Affiliation': 'From the Department of Surgery, The Ottawa Hospital, Ottawa, Ont. (Jarrar, Wu, Neville, Yelle, Mamazza); and the Department of Anesthesiology, The Ottawa Hospital, Ottawa, Ont. (Eipe).'}]",Canadian journal of surgery. Journal canadien de chirurgie,['10.1503/cjs.017719']
2706,34759049,Treatment of Age-Related Hearing Loss Alters Audiovisual Integration and Resting-State Functional Connectivity: A Randomized Controlled Pilot Trial.,"Untreated age-related hearing loss increases audiovisual integration and impacts resting state functional brain connectivity. Further, there is a relation between crossmodal plasticity and audiovisual integration strength in cochlear implant patients. However, it is currently unclear whether amplification of the auditory input by hearing aids influences audiovisual integration and resting state functional brain connectivity. We conducted a randomized controlled pilot study to investigate how the McGurk illusion, a common measure for audiovisual integration, and resting state functional brain connectivity of the auditory cortex are altered by six-month hearing aid use. Thirty-two older participants with slight-to-moderate, symmetric, age-related hearing loss were allocated to a treatment or waiting control group and measured one week before and six months after hearing aid fitting with functional magnetic resonance imaging. Our results showed a statistical trend for an increased McGurk illusion after six months of hearing aid use. We further demonstrated that an increase in McGurk susceptibility is related to a decreased hearing aid benefit for auditory speech intelligibility in noise. No significant interaction between group and time point was obtained in the whole-brain resting state analysis. However, a region of interest (ROI)-to-ROI analysis indicated that hearing aid use of six months was associated with a decrease in resting state functional connectivity between the auditory cortex and the fusiform gyrus and that this decrease was related to an increase of perceived McGurk illusions. Our study, therefore, suggests that even short-term hearing aid use alters audiovisual integration and functional brain connectivity between auditory and visual cortices. Significance Statement In this study, we showed that first time hearing aid use of six months was related to a decrease in resting state functional connectivity between the auditory cortex and the fusiform gyrus. The decreased connectivity was associated with an increase in perceived McGurk illusions. Further, this increase in McGurk illusions was correlated with decreased hearing aid benefit in auditory speech in noise intelligibility. Our study therefore suggests that hearing aid fitting impacts functional connectivity between auditory and visual regions and audiovisual integration (susceptibility to the McGurk illusion). Further our results suggest, that an increased McGurk susceptibility seems to inhibit the beneficial effect of the hearing aid when tested in auditory only conditions.",2021,No significant interaction between group and time point was obtained in the whole-brain resting state analysis.,"['cochlear implant patients', 'Thirty-two older participants with slight-to-moderate, symmetric, age-related hearing loss']","['Age-Related Hearing Loss Alters Audiovisual Integration and Resting-State Functional Connectivity', 'waiting control group and measured one week before and six months after hearing aid fitting with functional magnetic resonance imaging']","['McGurk illusions', 'McGurk illusion', 'resting state functional connectivity', 'crossmodal plasticity and audiovisual integration strength', 'perceived McGurk illusions']","[{'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",32.0,0.019287,No significant interaction between group and time point was obtained in the whole-brain resting state analysis.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Rosemann', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg 26111, Germany stephanie.rosemann@uni-oldenburg.de christiane.thiel@uni-oldenburg.de.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Gieseler', 'Affiliation': 'Cluster of Excellence ""Hearing4all,"" Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Tahden', 'Affiliation': 'Cluster of Excellence ""Hearing4all,"" Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Colonius', 'Affiliation': 'Cluster of Excellence ""Hearing4all,"" Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Christiane M', 'Initials': 'CM', 'LastName': 'Thiel', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg 26111, Germany stephanie.rosemann@uni-oldenburg.de christiane.thiel@uni-oldenburg.de.'}]",eNeuro,['10.1523/ENEURO.0258-21.2021']
2707,34759043,Treatment-free Survival after Immune Checkpoint Inhibitor Therapy versus Targeted Therapy for Advanced Renal Cell Carcinoma: 42-Month Results of the CheckMate 214 Trial.,"PURPOSE


Patients discontinuing immuno-oncology regimens may experience periods of disease control without need for ongoing anticancer therapy, but toxicity may persist. We describe treatment-free survival (TFS), with and without toxicity.
PATIENTS AND METHODS


Data were analyzed from the randomized phase III CheckMate 214 trial of nivolumab plus ipilimumab ( n  = 550) versus sunitinib ( n  = 546) for treatment-naïve, advanced renal cell carcinoma (aRCC). TFS was estimated by the 42-month restricted mean times defined by the area between Kaplan-Meier curves for two time-to-event endpoints defined from randomization: time to protocol therapy cessation and time to subsequent systemic therapy initiation or death. TFS was subdivided as TFS with and without toxicity by counting days with ≥1 grade ≥3 treatment-related adverse event (TRAE).
RESULTS


At 42 months since randomization, 52% of nivolumab plus ipilimumab and 39% of sunitinib intermediate/poor-risk patients were alive; 18% and 5% surviving treatment-free, respectively. Among favorable-risk patients, 70% and 73% of nivolumab plus ipilimumab and sunitinib patients were alive; 20% and 9% treatment-free. Over the 42-month period, mean TFS was over twice as long after nivolumab plus ipilimumab than sunitinib for intermediate/poor-risk (6.9 vs. 3.1 months) and three times as long for favorable-risk patients (11.0 vs. 3.7 months). Mean TFS with grade ≥3 TRAEs was a small proportion of time for both treatments (0.6 vs. 0.3 months after nivolumab plus ipilimumab vs. sunitinib for intermediate/poor-risk, and 0.9 vs. 0.3 months for favorable-risk patients).
CONCLUSIONS


Patients initiating first-line nivolumab plus ipilimumab for aRCC spent more survival time treatment-free without toxicity versus those on sunitinib, regardless of risk group.",2021,"CONCLUSIONS


Patients initiating first-line nivolumab plus ipilimumab for aRCC spent more survival time treatment-free without toxicity versus those on sunitinib, regardless of risk group.","['Advanced Renal Cell Carcinoma', ' n  = 550) versus sunitinib ( n  = 546) for treatment-naïve, advanced renal cell carcinoma (aRCC', 'Data were analyzed from the randomized phase III CheckMate 214 trial of']","['nivolumab plus ipilimumab', 'TFS', 'Immune Checkpoint Inhibitor Therapy']","['mean TFS', 'TFS', 'survival time']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",,0.0836699,"CONCLUSIONS


Patients initiating first-line nivolumab plus ipilimumab for aRCC spent more survival time treatment-free without toxicity versus those on sunitinib, regardless of risk group.","[{'ForeName': 'Meredith M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'Division of Biostatistics, Dana-Farber Cancer Institute, Boston, Massachusetts. mregan@jimmy.harvard.edu.'}, {'ForeName': 'Opeyemi A', 'Initials': 'OA', 'LastName': 'Jegede', 'Affiliation': 'Division of Biostatistics, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Charlene M', 'Initials': 'CM', 'LastName': 'Mantia', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Werner', 'Affiliation': 'Division of Biostatistics, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Chung-Han', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Urology, Niigata University, Niigata, Japan.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Voss', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Division of Genitourinary Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Vanderbilt Ingram Cancer Center, Nashville, Tennessee.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Hammers', 'Affiliation': 'Division of Hematology and Oncology, UT Southwestern, Dallas, Texas.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Huo', 'Affiliation': 'Worldwide Health Economics and Outcomes Research-US Market, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Del Tejo', 'Affiliation': 'US Medical Oncology, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Stwalley', 'Affiliation': 'Worldwide Health Economics and Outcomes Research-US Market, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Division of Hematology/Oncology, Georgetown-Lombardi Comprehensive Cancer Center, Washington, District of Columbia.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-2283']
2708,34759039,"Letter to the editor: prospective, double-blind diagnostic multicentre study of confocal laser endomicroscopy for wheat sensitivity in patients with irritable bowel syndrome.",,2021,,['patients with irritable bowel syndrome'],['confocal laser endomicroscopy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}]",[],,0.19825,,"[{'ForeName': 'Lukas Michaja', 'Initials': 'LM', 'LastName': 'Balsiger', 'Affiliation': 'Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tack', 'Affiliation': 'Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium jan.tack@kuleuven.be.'}]",Gut,['10.1136/gutjnl-2021-326252']
2709,34759036,Self-testing for HIV could increase diagnoses in the trans community.,"The studyWitzel TC, Wright T, McCabe L, et al. Impact and acceptability of HIV self-testing for trans men and trans women: A mixed-methods subgroup analysis of the SELPHI randomised controlled trial and process evaluation in England and Wales.  EClinicalMedicine  2021;32:100700.To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/hiv-self-testing-increases-diagnoses-trans-people/.",2021,Impact and acceptability of HIV self-testing for trans men and trans women:,['trans men and trans women'],"['EClinicalMedicine', 'HIV self-testing']",[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",[],,0.158832,Impact and acceptability of HIV self-testing for trans men and trans women:,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Saul', 'Affiliation': 'NIHR Centre for Engagement and Dissemination, Twickenham, UK NIHRAlerts@nihr.ac.uk.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Gursul', 'Affiliation': 'NIHR Centre for Engagement and Dissemination, Twickenham, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj.n2633']
2710,34759005,Effect of nutritionally modified infant formula on academic performance: linkage of seven dormant randomised controlled trials to national education data.,"OBJECTIVE


To compare differences in academic performance between adolescents who were randomised in infancy to modified or standard infant formula.
DESIGN


Linkage of seven dormant randomised controlled trials to national education data.
SETTING


Five hospitals in England, 11 August 1993 to 29 October 2001, and schools in England, September 2002 to August 2016.
PARTICIPANTS


1763 adolescents (425 born preterm, 299 born at term and small for gestational age, 1039 born at term) who took part in one of seven randomised controlled trials of infant formula in infancy.
INTERVENTIONS


Nutrient enriched versus standard term formula (two trials), long chain polyunsaturated fatty acid (LCPUFA) supplemented versus unsupplemented formula (two trials), high versus low iron follow-on formula (one trial), high versus low sn-2 palmitate formula (one trial), and nucleotide supplemented versus unsupplemented formula (one trial).
MAIN OUTCOME MEASURES


The primary outcome, determined by linkage of trial data to school data, was the mean difference in standard deviation scores for mandated examinations in mathematics at age 16 years. Secondary outcomes included differences in standard deviation scores in English (16 and 11 years) and mathematics (11 years). Analysis was by intention to treat with multiple imputation for participants missing the primary outcome.
RESULTS


1607 (91.2%) participants were linked to school records. No benefit was found for performance in mathematics examinations at age 16 years for any modified formula: nutrient enriched in preterm infants after discharge from hospital, standard deviation score 0.02 (95% confidence interval -0.22 to 0.27), and nutrient enriched in small for gestational age term infants -0.11 (-0.33 to 0.12); LCPUFA supplemented in preterm infants -0.19 (-0.46 to 0.08) and in term infants -0.14 (-0.36 to 0.08); iron follow-on formula in term infants -0.12 (-0.31 to 0.07); and sn-2 palmitate supplemented formula in term infants -0.09 (-0.37 to 0.19). Participants from the nucleotide trial were too young to have sat their General Certificate of Secondary Education (GCSE) examinations at the time of linkage to school data. Secondary outcomes did not differ for nutrient enriched, high iron, sn-2 palmitate, or nucleotide supplemented formulas, but at 11 years, preterm and term participants randomised to LCPUFA supplemented formula scored lower in English and mathematics.
CONCLUSIONS


Evidence from these randomised controlled trials indicated that the infant formula modifications did not promote long term cognitive benefit compared with standard infant formulas.",2021,"No benefit was found for performance in mathematics examinations at age 16 years for any modified formula: nutrient enriched in preterm infants after discharge from hospital, standard deviation score 0.02","['1763 adolescents (425 born preterm, 299 born at term and small for gestational age, 1039 born at term) who took part in one of seven randomised controlled trials of infant formula in infancy', 'adolescents who were randomised in infancy to modified or standard infant formula', 'Participants from the nucleotide trial were too young to have sat their General Certificate of Secondary Education (GCSE) examinations at the time of linkage to school data', 'Five hospitals in England, 11 August 1993 to 29 October 2001, and schools in England, September 2002 to August 2016', 'preterm infants -0.19']","['LCPUFA', 'nutritionally modified infant formula', 'Nutrient enriched versus standard term formula (two trials), long chain polyunsaturated fatty acid (LCPUFA) supplemented versus unsupplemented formula (two trials), high versus low iron follow-on formula (one trial), high versus low sn-2 palmitate formula (one trial), and nucleotide supplemented versus unsupplemented formula (one trial']","['academic performance', 'standard deviation scores in English (16 and 11 years) and mathematics (11 years', 'nutrient enriched, high iron, sn-2 palmitate, or nucleotide supplemented formulas', 'standard deviation scores', 'LCPUFA supplemented formula scored lower in English and mathematics']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3853282', 'cui_str': 'Standard infant formula'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0586303', 'cui_str': 'Certificate'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4517435', 'cui_str': '0.19'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0860975', 'cui_str': 'Iron low'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}]","[{'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0860976', 'cui_str': 'Iron increased'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",,0.479878,"No benefit was found for performance in mathematics examinations at age 16 years for any modified formula: nutrient enriched in preterm infants after discharge from hospital, standard deviation score 0.02","[{'ForeName': 'Maximiliane L', 'Initials': 'ML', 'LastName': 'Verfürden', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK m.verfuerden@alumni.ucl.ac.uk.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Gilbert', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Lucas', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jerrim', 'Affiliation': 'UCL Institute of Education, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fewtrell', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj-2021-065805']
2711,34759002,Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation.,"OBJECTIVE


To evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after breast cancer surgery.
DESIGN


Multicentre, pragmatic, superiority, randomised controlled trial with economic evaluation.
SETTING


17 UK National Health Service cancer centres.
PARTICIPANTS


392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to usual care with structured exercise (n=196) or usual care alone (n=196).
INTERVENTIONS


Usual care (information leaflets) only or usual care plus a physiotherapy led exercise programme, incorporating stretching, strengthening, physical activity, and behavioural change techniques to support adherence to exercise, introduced at 7-10 days postoperatively, with two further appointments at one and three months.
MAIN OUTCOME MEASURES


Disability of Arm, Hand and Shoulder (DASH) questionnaire at 12 months, analysed by intention to treat. Secondary outcomes included DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective.
RESULTS


Between 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis. 181 (95%) of 191 participants allocated to exercise attended at least one appointment. Upper limb function improved after exercise compared with usual care (mean DASH 16.3 (SD 17.6) for exercise (n=132); 23.7 (22.9) usual care (n=138); adjusted mean difference 7.81, 95% confidence interval 3.17 to 12.44; P=0.001). Secondary outcomes favoured exercise over usual care, with lower pain intensity at 12 months (adjusted mean difference on numerical rating scale -0.68, -1.23 to -0.12; P=0.02) and fewer arm disability symptoms at 12 months (adjusted mean difference on Functional Assessment of Cancer Therapy-Breast+4 (FACT-B+4) -2.02, -3.11 to -0.93; P=0.001). No increase in complications, lymphoedema, or adverse events was noted in participants allocated to exercise. Exercise accrued lower costs per patient (on average -£387 (€457; $533) (95% confidence interval -£2491 to £1718; 2015 pricing) and was cost effective compared with usual care.
CONCLUSIONS


The PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN35358984.",2021,"The PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications.
","['181 (95%) of 191 participants allocated to exercise attended at least one appointment', 'Between 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis', 'women at high risk of upper limb disability after breast cancer surgery', '392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to', '17 UK National Health Service cancer centres']","['Usual care (information leaflets) only or usual care plus a physiotherapy', 'structured exercise programme', 'Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER', 'PROSPER exercise programme', 'usual care with structured exercise (n=196) or usual care alone', 'usual care']","['clinically effective and cost effective and reduced upper limb disability', 'fewer arm disability symptoms', 'Functional Assessment of Cancer Therapy-Breast+4 (FACT-B+4', 'DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective', 'exercise over usual care, with lower pain intensity', 'Disability of Arm, Hand and Shoulder (DASH) questionnaire', 'Upper limb function', 'functional and health related quality of life outcomes', 'complications, lymphoedema, or adverse events']","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",392.0,0.0663333,"The PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications.
","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK julie.bruce@warwick.ac.uk.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Mazuquin', 'Affiliation': 'Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Canaway', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Anower', 'Initials': 'A', 'LastName': 'Hossain', 'Affiliation': 'Institute of Statistical Research and Training (ISRT), University of Dhaka, Dhaka, Bangladesh.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Williamson', 'Affiliation': 'Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Mistry', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Institute of Health Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Rees', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Padfield', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Raghavan', 'Initials': 'R', 'LastName': 'Vidya', 'Affiliation': 'Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Department of Surgery, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX 77030, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj-2021-066542']
2712,34758995,Effect of dexmedetomidine on postoperative delirium in patients undergoing brain tumour resections: study protocol of a randomised controlled trial.,"INTRODUCTION


Postoperative delirium (POD) is a common complication. The incidence of POD is about 25% in non-cardiac surgery and ranges from 10% to 30% in neurological procedures. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine on POD for patients undergoing craniotomy and tumour resections remains unclear.
METHODS AND ANALYSIS


The study is a prospective, single-centre, randomised, double-blinded, paralleled-group controlled trial. Patients undergoing elective frontotemporal tumour resections will be randomly assigned to the dexmedetomidine group and the control group. After endotracheal intubation, patients in the dexmedetomidine group will be administered with a loading dose of dexmedetomidine 0.6 µg/kg in 10 min followed by continuous infusion at a rate of 0.4 µg/kg/hour until the start of dural closure. In the control group, patients will receive the identical volume of normal saline in the same setting. The primary outcome will be the cumulative incidence of POD within 5 days. The delirium assessment will be performed by using the confusion assessment method in the first 5 consecutive days after surgery. Secondary outcomes include the pain severity assessed by Numerical Rating Scale pain score, quality of postoperative sleep assessed by the Richards Campbell sleep questionnaire and postoperative quality of recovery from anaesthesia by the Postoperative Quality Recovery Scale.
ETHICS AND DISSEMINATION


The protocol (V.1.0, 10 November 2020) has been approved by the Ethics Review Committee of the Chinese Clinical Trial Registry (number ChiECRCT-20200436). The findings of the study will be disseminated in a peer-reviewed journal and at a scientific conference.
TRIAL REGISTRATION NUMBER


NCT04674241.",2021,Patients undergoing elective frontotemporal tumour resections will be randomly assigned to the dexmedetomidine group and the control group.,"['patients undergoing brain tumour resections', 'patients undergoing craniotomy and tumour resections', 'patients undergoing non-cardiac surgery', 'Patients undergoing elective frontotemporal tumour resections']",['dexmedetomidine'],"['incidence of POD', 'incidence of delirium', 'postoperative delirium', 'pain severity assessed by Numerical Rating Scale pain score, quality of postoperative sleep assessed by the Richards Campbell sleep questionnaire and postoperative quality of recovery from anaesthesia by the Postoperative Quality Recovery Scale', 'cumulative incidence of POD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",,0.780115,Patients undergoing elective frontotemporal tumour resections will be randomly assigned to the dexmedetomidine group and the control group.,"[{'ForeName': 'Dexiang', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Ruowen', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Beijing, China florapym766@163.com.'}]",BMJ open,['10.1136/bmjopen-2021-051584']
2713,34758988,"Can the 'Learn in peace, educate without violence' intervention in Cote d'Ivoire reduce teacher violence? Development of a theory of change and formative evaluation results.","OBJECTIVES


To gather evidence on whether a brief intervention (Apprendre en paix et éduquer sans violence, developed by the Ivorian Ministry of Education and Graines de Paix) to promote peace in primary schools by reducing teacher violence perpetration and improving pedagogical techniques was acceptable to teachers and affected change in intermediate outcomes.
DESIGN


Mixed-methods formative research.
SETTING


Primary schools in Tonkpi region, Cote d'Ivoire.
PARTICIPANTS


160 teachers participating in the peace training, surveyed three times during implementation; qualitative in-depth interviews with 19 teachers and teacher-counsellors.
INTERVENTIONS


Learn in peace, educate without violence-a brief intervention with primary school teachers designed to promote peace in primary schools.
OUTCOMES


For survey data, we generated composite measures of intermediate outcomes (teachers' awareness of consequences of violence, self-efficacy in applying positive classroom management methods, acceptance of physical discipline practices in school) and used random intercept linear mixed-effects models to compare responses over time. Qualitative research included open-ended questions about acceptability and perceived need for such an intervention. A framework analysis was undertaken.
RESULTS


Four-months post-training (vs pretraining), teachers had higher self-efficacy in applying positive classroom management methods (pre-mean=26.1; post-mean=27.5; p<0.001) and borderline lower acceptance of physical discipline practices (premean=4.2; postmean=3.6; p=0.10). We found no change in teacher awareness of the consequences of violence. Qualitatively, teachers found the intervention acceptable and understandable, perceiving it as useful because it provided methods for non-violent discipline. Teachers had mixed views about whether the techniques improved classroom dynamics.
CONCLUSIONS


Data suggest that the intervention is acceptable and leads to change in intermediate outcomes for teachers. Further evaluation in a randomised controlled trial is warranted.",2021,"RESULTS


Four-months post-training (vs pretraining), teachers had higher self-efficacy in applying positive classroom management methods (pre-mean=26.1; post-mean=27.5; p<0.001) and borderline lower acceptance of physical discipline practices (premean=4.2; postmean=3.6; p=0.10).","[""Primary schools in Tonkpi region, Cote d'Ivoire.\nPARTICIPANTS\n\n\n160 teachers participating in the peace training, surveyed three times during implementation""]",[],"[""intermediate outcomes (teachers' awareness of consequences of violence, self-efficacy in applying positive classroom management methods, acceptance of physical discipline practices in school) and used random intercept linear mixed-effects models to compare responses over time"", 'borderline lower acceptance of physical discipline practices', 'self-efficacy']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],"[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2711040', 'cui_str': 'Borderline low'}]",160.0,0.083893,"RESULTS


Four-months post-training (vs pretraining), teachers had higher self-efficacy in applying positive classroom management methods (pre-mean=26.1; post-mean=27.5; p<0.001) and borderline lower acceptance of physical discipline practices (premean=4.2; postmean=3.6; p=0.10).","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Devries', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK karen.devries@lshtm.ac.uk.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Balliet', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kerrie', 'Initials': 'K', 'LastName': 'Thornhill', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Knight', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Procureur', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Yah Ariane Bernadette', 'Initials': 'YAB', 'LastName': ""N'Djoré"", 'Affiliation': ""Université Félix Houphouët-Boigny, Abidjan, Lagunes, Côte d'Ivoire.""}, {'ForeName': 'Dedou Gruzshca Ferrand', 'Initials': 'DGF', 'LastName': ""N'Guessan"", 'Affiliation': ""Université Félix Houphouët-Boigny, Abidjan, Lagunes, Côte d'Ivoire.""}, {'ForeName': 'Katherine G', 'Initials': 'KG', 'LastName': 'Merrill', 'Affiliation': 'Bloomburg School of Public Health Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Dally', 'Affiliation': ""Graines de Paix, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Mazeda', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Beniamino', 'Initials': 'B', 'LastName': 'Cislaghi', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Tanton', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Quintero', 'Affiliation': ""Graines de Paix, Abidjan, Côte d'Ivoire.""}]",BMJ open,['10.1136/bmjopen-2020-044645']
2714,34758970,Debunking highly prevalent health misinformation using audio dramas delivered by WhatsApp: evidence from a randomised controlled trial in Sierra Leone.,"INTRODUCTION


Infectious disease misinformation is widespread and poses challenges to disease control. There is limited evidence on how to effectively counter health misinformation in a community setting, particularly in low-income regions, and unsettled scientific debate about whether misinformation should be directly discussed and debunked, or implicitly countered by providing scientifically correct information.
METHODS


The Contagious Misinformation Trial developed and tested interventions designed to counter highly prevalent infectious disease misinformation in Sierra Leone, namely the beliefs that (1) mosquitoes cause typhoid and (2) typhoid co-occurs with malaria. The information intervention for group A (n=246) explicitly discussed misinformation and explained why it was incorrect and then provided the scientifically correct information. The intervention for group B (n=245) only focused on providing correct information, without directly discussing related misinformation. Both interventions were delivered via audio dramas on WhatsApp that incorporated local cultural understandings of typhoid. Participants were randomised 1:1:1 to the intervention groups or the control group (n=245), who received two episodes about breast feeding.
RESULTS


At baseline 51% believed that typhoid is caused by mosquitoes and 59% believed that typhoid and malaria always co-occur. The endline survey was completed by 91% of participants. Results from the intention-to-treat, per-protocol and as-treated analyses show that both interventions substantially reduced belief in misinformation compared with the control group. Estimates from these analyses, as well as an exploratory dose-response analysis, suggest that direct debunking may be more effective at countering misinformation. Both interventions improved people's knowledge and self-reported behaviour around typhoid risk reduction, and yielded self-reported increases in an important preventive method, drinking treated water.
CONCLUSION


These results from a field experiment in a community setting show that highly prevalent health misinformation can be countered, and that direct, detailed debunking may be most effective.
TRIAL REGISTRATION NUMBER


NCT04112680.",2021,"Both interventions improved people's knowledge and self-reported behaviour around typhoid risk reduction, and yielded self-reported increases in an important preventive method, drinking treated water.
",[],[],"[""people's knowledge and self-reported behaviour around typhoid risk reduction""]",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.040212,"Both interventions improved people's knowledge and self-reported behaviour around typhoid risk reduction, and yielded self-reported increases in an important preventive method, drinking treated water.
","[{'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Winters', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden maike.winters@ki.se.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Oppenheim', 'Affiliation': 'Center on International Cooperation, New York University, New York, New York, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sengeh', 'Affiliation': 'FOCUS1000, Freetown, Sierra Leone.'}, {'ForeName': 'Mohammad B', 'Initials': 'MB', 'LastName': 'Jalloh', 'Affiliation': 'FOCUS1000, Freetown, Sierra Leone.'}, {'ForeName': 'Nance', 'Initials': 'N', 'LastName': 'Webber', 'Affiliation': 'FOCUS1000, Freetown, Sierra Leone.'}, {'ForeName': 'Samuel Abu', 'Initials': 'SA', 'LastName': 'Pratt', 'Affiliation': 'FOCUS1000, Freetown, Sierra Leone.'}, {'ForeName': 'Bailah', 'Initials': 'B', 'LastName': 'Leigh', 'Affiliation': 'College of Medicine and Allied Health Sciences, Freetown, Sierra Leone.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Molsted-Alvesson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Zangin', 'Initials': 'Z', 'LastName': 'Zeebari', 'Affiliation': 'Department of Economics, Finance and Statistics, Jönköping International Business School, Jönköping, Sweden.'}, {'ForeName': 'Carl Johan', 'Initials': 'CJ', 'LastName': 'Sundberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Jalloh', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Nordenstedt', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]",BMJ global health,['10.1136/bmjgh-2021-006954']
2715,34758945,Oral Azacitidine (CC-486) for the Treatment of Myeloid Malignancies.,"Epigenetic dysregulation leads to aberrant DNA hypermethylation and is common in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). A large number of clinical trials in AML, MDS, and other hematologic malignancies have assessed hypomethylating agents (HMAs), used alone or in combination with other drugs, in the frontline, maintenance, relapsed/refractory, and peritransplant settings. Effective maintenance therapy has long been a goal for patients with AML in remission. Previous large, randomized clinical trials of maintenance with HMAs or other agents had not shown meaningful improvement in overall survival. Oral azacitidine (Oral-AZA [CC-486]) is approved in the United States, Canada, and European Union for treatment of adult patients with AML in first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy who are ineligible for hematopoietic cell transplant. Regulatory approvals of Oral-AZA were based on outcomes from the randomized, phase III QUAZAR AML-001 trial, which showed a median overall survival advantage of 9.9 months with Oral-AZA versus placebo. Oral-AZA allows convenient extended AZA dosing for 14 days per 28-day treatment cycle, which is not feasible with injectable AZA. Focusing on AML and MDS, this report reviews the rationale for the use of orally bioavailable AZA and its potential use in all-oral combination therapy regimens; the unique pharmacokinetic and pharmacodynamic profile of Oral-AZA compared with injectable AZA; the clinical safety and efficacy of Oral-AZA maintenance therapy in patients with AML in first remission and for treatment of patients with active MDS; and ongoing Oral-AZA clinical trials.",2021,"Previous large, randomized clinical trials of maintenance with HMAs or other agents had not shown meaningful improvement in overall survival.","['patients with AML in first remission and for treatment of patients with active MDS', 'patients with AML in remission', 'Myeloid Malignancies', 'acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS', 'adult patients with AML in first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy who are ineligible for hematopoietic cell transplant']","['bioavailable AZA', 'Oral-AZA maintenance therapy', 'Oral azacitidine (Oral-AZA [CC-486', 'injectable AZA', 'Oral Azacitidine (CC-486', 'Oral-AZA', 'Oral-AZA versus placebo']","['overall survival', 'median overall survival advantage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}, {'cui': 'C0153886', 'cui_str': 'Acute myeloid leukemia in remission'}, {'cui': 'C2939461', 'cui_str': 'Myeloid neoplasm'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}]","[{'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.248105,"Previous large, randomized clinical trials of maintenance with HMAs or other agents had not shown meaningful improvement in overall survival.","[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: ggarciam@mdanderson.org.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'Department of Clinical Haematology, The Alfred Hospital, Melbourne, Australia; Monash University, Australian Centre for Blood Diseases, Melbourne, Australia.'}, {'ForeName': 'Ignazia', 'Initials': 'I', 'LastName': 'La Torre', 'Affiliation': 'Celgene, a Bristol Myers Squibb Company, Boudry, Switzerland.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Skikne', 'Affiliation': 'Bristol-Myers Squibb Company, Princeton, NJ; Department of Hematology, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Beach', 'Affiliation': 'Bristol-Myers Squibb Company, Princeton, NJ.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Santini', 'Affiliation': 'MDS Unit, Hematology, AOU Careggi, University of Florence, Florence, Italy.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2021.09.021']
2716,34758887,Perspectives on extended-release naltrexone induction among patients living with HIV and opioid use disorder: a qualitative analysis.,"BACKGROUND


The CHOICES study randomized participants with HIV and opioid use disorder (OUD) to HIV clinic-based extended-release naltrexone (XR-NTX), which requires complete cessation of opioid use, versus treatment-as-usual (i.e., buprenorphine, methadone). Study participants randomized to XR-NTX were interviewed to assess their experiences with successful and unsuccessful XR-NTX induction.
METHODS


Semi-structured qualitative interviews were completed with a convenience sample of study participants with HIV and OUD (n = 37) randomized to XR-NTX in five HIV clinics between 2018 and 2019. All participants approached agreed to be interviewed. Interviews were digitally recorded, professionally transcribed, and analyzed using thematic analysis.
RESULTS


Participants included women (43%), African Americans (62%) and Hispanics (16%), between 27 to 69 years of age. Individuals who completed XR-NTX induction (n = 20) reported experiencing (1) readiness for change, (2) a supportive environment during withdrawal including comfort medications, and (3) caring interactions with staff. Four contrasting themes emerged among participants (n = 17) who did not complete induction: (1) concern and anxiety about withdrawal including past negative experiences, (2) ambivalence about or reluctance to stop opioids, (3) concerns about XR-NTX effects, and (4) preferences for other medications.
CONCLUSIONS


The results highlight opportunities to improve initiation of XR-NTX in high-need groups. Addressing expectations regarding induction may enhance XR-NTX initiation rates. Trial Registration ClinicalTrials.gov: NCT03275350. Registered September 7, 2017. https://clinicaltrials.gov/ct2/show/NCT03275350?term=extended+release+naltrexone&cond=Opioid+Use .",2021,"Four contrasting themes emerged among participants (n = 17) who did not complete induction: (1) concern and anxiety about withdrawal including past negative experiences, (2) ambivalence about or reluctance to stop opioids, (3) concerns about XR-NTX effects, and (4) preferences for other medications.
","['Individuals who completed XR-NTX induction (n\u2009=\u200920) reported experiencing (1) readiness for change, (2) a supportive environment during withdrawal including comfort medications, and (3) caring interactions with staff', 'in five HIV clinics between 2018 and 2019', 'participants (n\u2009=\u200917) who did not complete induction: (1) concern and anxiety about withdrawal including past negative experiences, (2) ambivalence about or reluctance to stop opioids, (3) concerns about XR-NTX effects, and (4) preferences for other medications', 'Participants included women (43%), African Americans (62%) and Hispanics (16%), between 27 to 69\xa0years of age', 'Semi-structured qualitative interviews were completed with a convenience sample of study participants with HIV and OUD (n\u2009=\u200937) randomized to', 'participants with HIV and opioid use disorder (OUD) to HIV clinic-based extended-release', 'patients living with HIV and opioid use disorder']","['XR-NTX', 'buprenorphine, methadone', 'naltrexone (XR-NTX']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0233495', 'cui_str': 'Feeling mixed emotions'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]",[],,0.191523,"Four contrasting themes emerged among participants (n = 17) who did not complete induction: (1) concern and anxiety about withdrawal including past negative experiences, (2) ambivalence about or reluctance to stop opioids, (3) concerns about XR-NTX effects, and (4) preferences for other medications.
","[{'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Hoffman', 'Affiliation': 'Oregon Health and Science University-Portland State University School of Public Health, Portland, OR, USA. hoffmaki@ohsu.edu.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Baker', 'Affiliation': 'Oregon Health and Science University-Portland State University School of Public Health, Portland, OR, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Fanucchi', 'Affiliation': 'College of Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Lum', 'Affiliation': 'Department of Medicine, Division of HIV, ID & Global Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Kunkel', 'Affiliation': 'Department of Medicine, Section of Addiction Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ponce Terashima', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'McCarty', 'Affiliation': 'Department of Medicine, Division of HIV, ID & Global Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Jacobs', 'Affiliation': 'National Institute on Drug Abuse, Center for the Clinical Trials Network, North Bethesda, MD, USA.'}, {'ForeName': 'P Todd', 'Initials': 'PT', 'LastName': 'Korthuis', 'Affiliation': 'Oregon Health and Science University-Portland State University School of Public Health, Portland, OR, USA.'}]",Addiction science & clinical practice,['10.1186/s13722-021-00277-z']
2717,34758875,The impact of stress management training on stress-related coping strategies and self-efficacy in hemodialysis patients: a randomized controlled clinical trial.,"INTRODUCTION


Dialysis causes many psychological and social problems, such as stress and inefficiency in patients, which should be considered in health promotion interventions. Therefore, this study aimed to determine the impact of stress management training on stress coping strategies and the self-efficacy of these patients in southeastern Iran.
METHODS


This quasi-experimental study was a randomized controlled clinical trial was conducted on hemodialysis patients from December 2019 to January 2020. Patients who met inclusion criteria were selected with the convenience sampling method and divided into the two groups of intervention (n = 30) and control (n = 30) by using the block randomization method. Participants in the intervention group were trained in a stress management training program in 8 one-and-a-half-hour sessions, held twice a week. Data were measured with stress coping strategies and general self-efficacy questionnaires before, immediately, and 1 month after the intervention. SPSS18 was used for data analysis.
RESULTS


The study results showed that the scores of stress coping strategies and the self-efficacy score in all their dimensions were significantly different between the intervention and control groups (P < 0.001).
CONCLUSION


The present study results showed that stress management training programs promoted stress coping strategies and self-efficacy in hemodialysis patients. Health planners and nurses are recommended to use these easy, feasible, and inexpensive interventions to reduce stress and increase self-efficacy. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20160914029817N10. Date of registration: October 7, 2021. URL: https://en.irct.ir/trial/58540 . Registration timing: a retrospective.",2021,"Data were measured with stress coping strategies and general self-efficacy questionnaires before, immediately, and 1 month after the intervention.","['hemodialysis patients from December 2019 to January 2020', 'hemodialysis patients']","['stress management training', 'stress management training program', 'URL']","['stress coping strategies and general self-efficacy questionnaires', 'scores of stress coping strategies and the self-efficacy score', 'stress coping strategies and self-efficacy', 'stress-related coping strategies and self-efficacy']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3541384', 'cui_str': 'URL'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.00843462,"Data were measured with stress coping strategies and general self-efficacy questionnaires before, immediately, and 1 month after the intervention.","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Ghasemi Bahraseman', 'Affiliation': 'Nursing Research Center, Razi Faculty of Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mangolian Shahrbabaki', 'Affiliation': 'Department of critical Care Nursing, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Nouhi', 'Affiliation': 'Department of critical Care Nursing, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran. e_nuhi@kmu.ac.ir.'}]",BMC psychology,['10.1186/s40359-021-00678-4']
2718,34759287,Effects of short-term bisoprolol on perioperative myocardial injury in patients undergoing non-cardiac surgery: a randomized control study.,"The protective role of preoperative beta-blocker in patients undergoing non-cardiac surgery is unknown. We aimed to evaluate the effects of beta-blocker on perioperative myocardial injury in patients undergoing non-cardiac surgery. We consecutively enrolled 112 patients undergoing non-cardiac surgery. They were randomly allocated to receive bisoprolol or placebo given at least 2 days preoperatively and continued until 30 days after surgery. The primary outcome was incidence of perioperative myocardial injury defined by a rise of high-sensitive troponin-T (hs-TnT) more than 99th percentile of upper reference limit or a rise of hs-TnT more than 20% if baseline level is abnormal. Baseline characteristics were comparable between bisoprolol and placebo in randomized cohort Mean age was 62.5 ± 11.8 years and 76 (67.8%) of 112 patients were male. Among 112 patients, 49 (43.8%) underwent vascular surgery and 63 (56.2%) underwent thoracic surgery. The median duration of assigned treatment prior to surgery was 4 days (2-6 days). We did not demonstrate the significant difference in the incidence of perioperative myocardial injury [52.6% (30 of 57 patients) vs. 49.1% (27 of 55 patients), P = 0.706]. In addition, the incidence of intraoperative hypotension was higher in bisoprolol group than placebo group in patients undergoing non-cardiac surgery [70.2% (40 of 57 patients) vs. 47.3% (26 of 55 patients), P = 0.017]. We demonstrated that there was no statistically significant difference in perioperative myocardial injury observed between patients receiving bisoprolol and placebo who had undergone non-cardiac surgery.",2021,"We did not demonstrate the significant difference in the incidence of perioperative myocardial injury [52.6% (30 of 57 patients) vs. 49.1% (27 of 55 patients), P = 0.706].","['randomized cohort Mean age was 62.5\u2009±\u200911.8\xa0years and 76 (67.8%) of 112 patients were male', '112 patients, 49 (43.8%) underwent vascular surgery and 63 (56.2%) underwent thoracic surgery', '112 patients undergoing non-cardiac surgery', 'patients undergoing non-cardiac surgery']","['preoperative beta-blocker', 'bisoprolol or placebo', 'short-term bisoprolol', 'bisoprolol and placebo', 'placebo', 'beta-blocker']","['incidence of perioperative myocardial injury defined by a rise of high-sensitive troponin-T (hs-TnT) more than 99th percentile of upper reference limit or a rise of hs-TnT', 'median duration', 'incidence of intraoperative hypotension', 'perioperative myocardial injury']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}]",112.0,0.371302,"We did not demonstrate the significant difference in the incidence of perioperative myocardial injury [52.6% (30 of 57 patients) vs. 49.1% (27 of 55 patients), P = 0.706].","[{'ForeName': 'Wanwarang', 'Initials': 'W', 'LastName': 'Wongcharoen', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Thanyalak', 'Initials': 'T', 'LastName': 'Chotayaporn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kavint', 'Initials': 'K', 'LastName': 'Chutikhongchalermroj', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Apichat', 'Initials': 'A', 'LastName': 'Tantraworasin', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Somcharoen', 'Initials': 'S', 'LastName': 'Saeteng', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Supapong', 'Initials': 'S', 'LastName': 'Arworn', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kittipan', 'Initials': 'K', 'LastName': 'Rerkasem', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Arintaya', 'Initials': 'A', 'LastName': 'Phrommintikul', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. arintaya.p@cmu.ac.th.'}]",Scientific reports,['10.1038/s41598-021-01365-5']
2719,34759278,A randomized cross-over trial investigating differences in 24-h personal air and skin temperatures using wearable sensors between two climatologically contrasting settings.,"The influence of elevated air temperatures recorded in various urban microenvironments in adversely impacting biologically relevant disease end points has not yet been extensively tackled. This study is a post hoc analysis of the TEMP pilot trial, a randomized 2 × 2 cross-over trial that examined changes in metabolic and stress hormonal profiles of healthy adults in two settings (urban vs. rural) with distinctly different climatological characteristics during the Mediterranean summer. This analysis aimed to study the association between the 24-h personal air or skin temperature sensor measurements and the diary-based location type (indoors vs. outdoors) in urban (seaside) vs. rural (higher in altitude) microenvironments. Out of 41 eligible participants, a total of 37 participants were included in this post-hoc TEMP trial analysis. Wearable sensors recorded personal air temperature, skin temperature, and activity (as a surrogate marker of physical activity) in each setting, while a time-stamped personal diary recorded the types of indoor or outdoor activities. Temperature peaks during the 24-h sampling period were detected using a peak finding algorithm. Mixed effect logistic regression models were fitted for the odds of participant location (being indoors vs. outdoors) as a function of setting (urban vs. rural) and sensor-based personal temperature data (either raw temperature values or number of temperature peaks). During the study period (July-end of September), median [interquartile range, IQR] personal air temperature in the rural (higher altitude) settings was 1.5 °C lower than that in the urban settings (27.1 °C [25.4, 29.2] vs. 28.6 °C [27.1, 30.5], p < 0.001), being consistent with the Mediterranean climate. Median [IQR] personal air temperature in indoor (micro)environments was lower than those in outdoors (28.0 °C [26.4, 30.3] vs 28.5 °C [26.8, 30.7], p < 0.001). However, median [IQR] skin temperature was higher in indoor (micro)environments vs. outdoors (34.8 °C [34.0, 35.6] and 33.9 °C [32.9, 34.8], p < 0.001) and the number of both personal air and skin temperature peaks was higher indoors compared to outdoors (median [IQR] 3.0 [2.0,4.0] vs 1.0 [1.0,1.3], p < 0.007, for the skin sensors). A significant association between the number of temperature peaks and indoor location types was observed with either the personal air sensor (OR 3.1; 95% CI 1.2-8.2; p = 0.02) or the skin sensor (OR 3.7; 95% CI 1.4-9.9; p = 0.01), suggesting higher number of indoor air temperature fluctuations. Amidst the global climate crisis, more population health studies or personalized medicine approaches that utilize continuous tracking of individual-level air/skin temperatures in both indoor/outdoor locations would be warranted, if we were to better characterize the disease phenotype in response to climate change manifestations.",2021,"p < 0.001) and the number of both personal air and skin temperature peaks was higher indoors compared to outdoors (median [IQR] 3.0 [2.0,4.0] vs 1.0 [1.0,1.3], p < 0.007, for the skin sensors).","['41 eligible participants, a total of 37 participants were included in this post-hoc TEMP trial analysis', 'urban\xa0(seaside) vs. rural (higher in altitude) microenvironments', 'healthy adults in two settings (urban vs. rural)\xa0with distinctly different climatological characteristics\xa0during the Mediterranean summer']","['24-h personal air or skin temperature sensor measurements and the diary-based location type (indoors vs. outdoors', 'micro)environments']","['indoor air temperature fluctuations', 'median [interquartile range,\xa0IQR] personal air temperature', 'personal air temperature, skin temperature, and activity (as a surrogate marker of physical activity', 'median [IQR]\xa0skin temperature', 'number of both personal air and skin temperature peaks', 'number of temperature peaks and indoor location types', 'Median [IQR] personal air temperature in indoor (micro)environments', 'skin sensor', '24-h personal air and skin temperatures', 'Temperature peaks']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0086589', 'cui_str': 'Marker, Surrogate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]",37.0,0.0899442,"p < 0.001) and the number of both personal air and skin temperature peaks was higher indoors compared to outdoors (median [IQR] 3.0 [2.0,4.0] vs 1.0 [1.0,1.3], p < 0.007, for the skin sensors).","[{'ForeName': 'Andria', 'Initials': 'A', 'LastName': 'Constantinou', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Oikonomou', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Konstantinou', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Konstantinos C', 'Initials': 'KC', 'LastName': 'Makris', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus. konstantinos.makris@cut.ac.cy.'}]",Scientific reports,['10.1038/s41598-021-01180-y']
2720,34759247,"Tailored Strategy for Locally-Advanced Rectal Carcinoma (GRECCAR 4): Long-term Results from a Multicenter, Randomized, Open-Label, Phase 2 Trial.","BACKGROUND


Systematic preoperative radiochemotherapy and total mesorectal excision are standard-of-care for locally-advanced rectal carcinoma. Some patients can be over- or undertreated.
OBJECTIVE


Long-term oncological, functional and late morbidity outcomes after tailored radiochemotherapy and induction high-dose chemotherapy.
DESIGN


Prospective, phase II, multicenter, open-label study at 16 tertiary centers in France.
SETTINGS


Patients operated by surgeons from the French GRECCAR group.
PATIENTS


206 patients were randomly assigned to treatment: good responders after chemotherapy (≥75% tumor volume reduction) to immediate surgery (arm A) or standard radiochemotherapy (Cap 50) plus surgery (arm B); poor responders to Cap 50 (arm C) or intensive radiochemotherapy (Cap 60 (60 Gy irradiation) (arm D) before surgery.
INTERVENTIONS


Tailored treatment according to MR response to induction CT.
RESULTS


After induction treatment, 194 patients were classified as good (n=30, 15%) or poor (n=164, 85%) responders, and included in arms A and B (16 and 14 patients) or C and D (113 and 51 patients). The primary objective was obtained: R0 resection rates [90% confidence interval] in the four arms respectively were 100% [74-100], 100% [85-100], 83% [72-91], and 88% [77-95]. At 5 years, rates were: overall survival 90% [47.3-98.5], 93.3% [61.3-99.0], 84.3% [71.0-91.8], 86.1% [71.6-93.5]; disease-free survival 80% [40.9-94.6], 89.5% [64.1-97.3], 72.9% [58.5-82.9], 72.8% [57.7-83.2]; local recurrence 0, 0, 2.1% [0.3-13.9], 9.3% [3.6-23.0]; metastasis 20% [5.4-59.1], 10.5% [2.7-35.9], 18% [31.8-94.6], 18.8% [10.2-33.0]. Late morbidity and quality of life evaluations showed no significant difference between arms.
LIMITATIONS


limitations due to the small number of patients randomized in the good responder arms, especially arm A without radiotherapy.
CONCLUSION


Tailoring preoperative radiochemotherapy-based on induction treatment response appears to be promising. Future prospective trials should confirm this strategy. See Video Abstract at http://links.lww.com/DCR/B761.ClinicalTrials.gov Identifier: NCT01333709.",2021,"Late morbidity and quality of life evaluations showed no significant difference between arms.
","['Locally-Advanced Rectal Carcinoma (GRECCAR 4', '194 patients were classified as good (n=30, 15%) or poor (n=164, 85%) responders, and included in arms A and B (16 and 14 patients) or C and D (113 and 51 patients', '16 tertiary centers in France', 'locally-advanced rectal carcinoma', '206 patients', 'Patients operated by surgeons from the French GRECCAR group']","['radiochemotherapy and induction high-dose chemotherapy', 'radiochemotherapy and total mesorectal excision', 'chemotherapy (≥75% tumor volume reduction) to immediate surgery (arm A) or standard radiochemotherapy (Cap 50) plus surgery (arm B); poor responders to Cap 50 (arm C) or intensive radiochemotherapy (Cap 60 (60 Gy irradiation) (arm D) before surgery']","['disease-free survival', 'R0 resection rates', 'Late morbidity and quality of life evaluations', 'overall survival', 'local recurrence']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0167771', 'cui_str': 'calcyclin-associated protein 50'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0631191', 'cui_str': 'calmodulin acceptor protein 60'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",206.0,0.0430648,"Late morbidity and quality of life evaluations showed no significant difference between arms.
","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rouanet', 'Affiliation': 'Institut régional du Cancer de Montpellier (ICM), Montpellier, France Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France Institut Paoli-Calmettes, Marseille, France APHP, Pitié-Salpêtrière, Paris Centre Hospitalier Universitaire de Rouen, Rouen, France Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rullier', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Lelong', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Maingon', 'Affiliation': ''}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pezet', 'Affiliation': ''}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Castan', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Nougaret', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000002153']
2721,34759239,"Pudendal Nerve Block For Post-hemorrhoidectomy Pain: A Prospective, Single-Blinded Randomized Control Trial.","BACKGROUND


Postoperative pain is common in hemorrhoidectomy patients. Local anesthetic given either as an intraoperative pudendal nerve block or as a local wound infiltration may help alleviate postoperative pain.
OBJECTIVES


This study sought to determine whether the addition of an intra-operative pudendal nerve block to a perianal local wound infiltration and standardized analgesia regimen was superior to a perianal local wound infiltration and standardized analgesia regimen alone in reducing early post-operative pain following hemorrhoidectomy. Secondary objectives included perceived perianal numbness, oral opioid requirements and adverse events reported.
DESIGN


This study was a prospective, single-blinded randomized controlled trial approved by the Eastern Health Human Research and Ethics Committee in Melbourne, Australia (registration number: E09/2014).
SETTINGS


Patients were recruited across three Australian hospitals.
PATIENTS


Eighty patients were successfully enrolled in the study, with one patient later dropping out.
INTERVENTION


Patients were randomized to either the pudendal nerve block group or a control group. The pudendal nerve block group received 5mls bupivacaine 0.5% with adrenaline 1:200,000 to both pudendal nerve trunks bilaterally. Both groups received 10mls of the same local anesthetic injected into the post hemorrhoidectomy wound bed.
MAIN OUTCOME MEASURES


Visual analogue scales were used to record patient pain scores. Dichotomous (yes/no) answers were recorded for secondary objectives.
RESULTS


There were no significant differences in post-operative pain between groups at 4 hours, 8 hours, 12 hours, or 24 hours. Additionally, there were no significant differences between groups with respect to perceived perianal numbness, oral opioid usage or adverse events.
LIMITATIONS


The authors recognize that without a nerve stimulator, an argument can be made that the pudendal nerve block was not actually achieved.
CONCLUSION


Pudendal nerve block does not appear to demonstrate additional benefit in post-hemorrhoidectomy pain reduction beyond local anesthetic to the wound. See Video Abstract at http://links.lww.com/DCR/B780.",2021,Pudendal nerve block does not appear to demonstrate additional benefit in post-hemorrhoidectomy pain reduction beyond local anesthetic to the wound.,"['Eighty patients were successfully enrolled in the study, with one patient later dropping out', 'Eastern Health Human Research and Ethics Committee in Melbourne, Australia (registration number: E09/2014', 'hemorrhoidectomy patients', 'Patients were recruited across three Australian hospitals']","['pudendal nerve block group or a control group', 'hemorrhoidectomy', 'bupivacaine', 'Pudendal Nerve Block For Post-hemorrhoidectomy Pain', 'local anesthetic injected into the post hemorrhoidectomy wound bed', 'adrenaline 1:200,000 to both pudendal nerve trunks bilaterally']","['patient pain scores', 'perianal numbness, oral opioid usage or adverse events', 'perianal numbness, oral opioid requirements and adverse events reported', 'post-operative pain']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0228959', 'cui_str': 'Structure of pudendal nerve'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0442158', 'cui_str': 'Perianal'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",80.0,0.279784,Pudendal nerve block does not appear to demonstrate additional benefit in post-hemorrhoidectomy pain reduction beyond local anesthetic to the wound.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Steen', 'Affiliation': 'Department of Colorectal Surgery, Eastern Health, Victoria, Australia Adjunct Senior Lecturer, Monash University, Eastern Clinical School, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'Raaj', 'Initials': 'R', 'LastName': 'Chandra', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Chua', 'Affiliation': ''}, {'ForeName': 'Vinna', 'Initials': 'V', 'LastName': 'An', 'Affiliation': ''}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Keck', 'Affiliation': ''}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000002293']
2722,34759229,"Efficacy and safety of a parylene-coated occluder for atrial septal defect: a prospective, multi-center, randomized controlled clinical trial.","BACKGROUND


Nitinol-containing devices are widely used in clinical practice. However, there are concerns about nickel release after nitinol-containing device implantation. This study aimed to compare the efficacy and safety of a parylene-coated occluder vs. a traditional nitinol-containing device for atrial septal defect (ASD).
METHODS


One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder (n = 54) or the control group to receive a traditional occluder (n = 54). The plugging success rate at 6 months after device implantation and the pre- and post-implantation serum nickel levels were compared between the two groups. A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device. The Cochran-Mantel-Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups.
RESULTS


At 6 months after implantation, successful ASD closure was achieved in 52 of 53 patients (98.11%) in both the trial and control groups (95% confidence interval (CI): [-4.90, 5.16]) based on per-protocol set analysis. The absolute value of the lower limit of the 95% CI was 4.90%, which was less than the specified non-inferiority margin of 8%. No deaths or severe complications occurred during 6 months of follow-up. The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group (P < 0.05 vs. baseline). In the trial group, there was no significant difference in the serum nickel level before vs. after device implantation (P > 0.05).
CONCLUSIONS


The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder. The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD, especially in patients with a nickel allergy.",2021,The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder.,"['atrial septal defect', 'One-hundred-and-eight patients with ASD', 'patients with a nickel allergy']","['parylene-coated occluder', 'parylene-coated occluder vs. a traditional nitinol-containing device', 'parylene-coated occluder (n\u200a=\u200a54) or the control group to receive a traditional occluder', 'parylene-coated ASD occluder']","['deaths or severe complications', 'serum nickel level', 'plugging success rate', 'successful ASD closure', 'efficacy and safety', 'Efficacy and safety', 'serum nickel levels']","[{'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028013', 'cui_str': 'nickel'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}]","[{'cui': 'C0070131', 'cui_str': 'parylene'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373682', 'cui_str': 'Nickel measurement'}, {'cui': 'C0182324', 'cui_str': 'Plug'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0189965', 'cui_str': 'Atrioseptoplasty'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",108.0,0.0757837,The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder.,"[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Center of Structural Heart Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100037, China Department of Magnetic Resonance Imaging, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100037, China Department of Interventional Diagnosis and Treatment, Anzhen Hospital, Capital Medical University, Beijing 100011, China Department of Cardiology, Fuwai Central China Cardiovascular Hospital, Zhengzhou University, Zhengzhou, Henan 450000, China Department of Cardiology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China Department of Cardiac Surgery, Qinghai Province Cardiovascular and Cerebrovascular Disease Specialist Hospital, Xining 810012, China Department of Radiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100037, China Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Lyu', 'Affiliation': ''}, {'ForeName': 'Hai-Bo', 'Initials': 'HB', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Wen-Hui', 'Initials': 'WH', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Ge-Jun', 'Initials': 'GJ', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jing-Lin', 'Initials': 'JL', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Yu-Hao', 'Initials': 'YH', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Shi-Hua', 'Initials': 'SH', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Shi-Liang', 'Initials': 'SL', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiang-Bin', 'Initials': 'XB', 'LastName': 'Pan', 'Affiliation': ''}]",Chinese medical journal,['10.1097/CM9.0000000000001865']
2723,34759182,Subacromial Injections of Low- or High-Molecular-Weight Hyaluronate Versus Physical Therapy for Shoulder Tendinopathy: A Randomized Triple-Blind Controlled Trial.,"OBJECTIVE


Shoulder tendinopathy is a prevalent and debilitating problem. We compared the effects of subacromial high- or low-molecular-weight hyaluronate injection with physical therapy (PT) in shoulder tendinopathy.
DESIGN


A triple-blinded randomized controlled trial.
SETTING


We conducted the trial in an outpatient clinic at a teaching hospital.
PARTICIPANTS


In total, 79 patients with shoulder tendinopathy were randomly allocated to high- (n = 27) or low-molecular-weight (n = 28) hyaluronate or PT (n = 24) groups.
INTERVENTIONS


We administered a 20-mg injection of high- or low-molecular-weight hyaluronate. For PT, we prescribed 10 sessions of physiotherapy and exercise.
OUTCOME MEASURES


The primary outcome was shoulder pain and the secondary outcomes included Disability of the Arm Shoulder and Hand score, shoulder range of movement and QoL. We measured the outcomes at baseline, 1, and 3 months of treatment, and assessed shoulder pain at the sixth month postintervention.
RESULTS


The interventions were all clinically beneficial in the management of tendinopathy for high- (n = 25) and low-molecular-weight (n = 24) hyaluronate and PT (n = 19) groups (all P < 0.05). However, between-group analyses indicated that hyaluronate preparations were more effective in controlling pain, decreasing disability, increasing range of motion, and improving the quality of life (all P < 0.05). The pain and subjective feeling of rigidity at the injection area (P = 0.012) were less prominent for low-molecular-weight hyaluronate.
CONCLUSION


High- or low-molecular-weight hyaluronate is more effective than PT in the treatment of shoulder tendinopathy. The clinical benefits of hyaluronate last for at least 3 months, and the pain alleviation sustains partially for 6 months. Shoulder injection of low-molecular-weight hyaluronate is more tolerable to the patient than high-molecular-weight hyaluronate.",2021,"The pain and subjective feeling of rigidity at the injection area (P = 0.012) were less prominent for low-molecular-weight hyaluronate.
","['outpatient clinic at a teaching hospital', '79 patients with shoulder tendinopathy', 'Shoulder Tendinopathy']","['Subacromial Injections of Low- or High-Molecular-Weight', 'Hyaluronate Versus Physical Therapy', 'Shoulder injection of low-molecular-weight hyaluronate', 'low-molecular-weight (n = 28) hyaluronate or PT', 'subacromial high- or low-molecular-weight hyaluronate injection with physical therapy (PT']","['shoulder pain', 'pain and subjective feeling of rigidity', 'controlling pain, decreasing disability, increasing range of motion, and improving the quality of life', 'Disability of the Arm Shoulder and Hand score, shoulder range of movement and QoL. We measured the outcomes at baseline, 1, and 3 months of treatment, and assessed shoulder pain', 'pain alleviation sustains']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0178695', 'cui_str': 'hyaluronate'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0856432', 'cui_str': 'Shoulder injection'}, {'cui': 'C4307026', 'cui_str': 'hyaluronate Injection [Hyalgan]'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",79.0,0.0920831,"The pain and subjective feeling of rigidity at the injection area (P = 0.012) were less prominent for low-molecular-weight hyaluronate.
","[{'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Esmaily', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Clinical Biomechanics and Ergonomics Research Center, Faculty of Medicine, Aja University of Medical Sciences, Tehran, Iran; and Department of Food Hygiene and Technology, University of Leon, Leon, Spain.'}, {'ForeName': 'Rezvaneh', 'Initials': 'R', 'LastName': 'Mohebbi', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rezasoltani', 'Affiliation': ''}, {'ForeName': 'Seyedalireza', 'Initials': 'S', 'LastName': 'Kasaiyan', 'Affiliation': ''}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dadarkhah', 'Affiliation': ''}, {'ForeName': 'Mahshad', 'Initials': 'M', 'LastName': 'Mir', 'Affiliation': ''}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000988']
2724,34759176,Difluprednate 0.05% twice a day vs Prednisolone acetate 1% four times a day for cataract postsurgical inflammation treatment: a non-inferiority trial.,"PURPOSE


To establish if Difluprednate 0.05% nanoemulsion (DIFL) twice a day (BID) is as effective as Prednisolone acetate 1% + Phenylephrine hydrochloride 0.12% suspension (PRED) four times a day (QID) on postsurgical inflammation treatment.
SETTING


4 private Argentine ophthalmological centers.
DESIGN


Non-inferiority, prospective, multicenter, double-blind, randomized, parallel-group, comparative trial.
METHODS


A total of 259 patients who underwent phacoemulsification randomly received DIFL or PRED starting the day before surgery and continuing for 28 days. The primary endpoint was central corneal thickness. Non-inferior anti-inflammatory efficacy was considered if the difference of corneal thickness between baseline and Day 4 did not differ beyond 17 µm between treatments. Secondary endpoints were cell & flare, corrected distance visual acuity (CDVA), endothelial cell count, OCT-central macular thickness, and intraocular pressure (IOP). All outcomes were evaluated at baseline, day 1, 4, and 28 after surgery.
RESULTS


225 patients finished the study. The difference in corneal thickness at baseline and Day 4 did not differ beyond 17 µm between treatments (IC95% -2.78µm - 14,84 µm), with no statistically significant difference between treatments (p = 0.523). There were not statistically significant differences between groups on total anterior chamber clearance at any study time (p > 0.05). No statistically significant differences were reported between treatments in CDVA (p = 0.455), endothelial cell count (p = 0.811), OCT-central macular thickness (p = 0.869), and in intraocular pressure outcome (p = 0.316).
CONCLUSIONS


Difluprednate administered BID is at least as effective as Prednisolone acetate administered QID on inflammatory treatment following cataract surgery.",2021,"No statistically significant differences were reported between treatments in CDVA (p = 0.455), endothelial cell count (p = 0.811), OCT-central macular thickness (p = 0.869), and in intraocular pressure outcome (p = 0.316).
","['259 patients who underwent phacoemulsification randomly received', '4 private Argentine ophthalmological centers', '225 patients finished the study']","['Prednisolone acetate 1% + Phenylephrine hydrochloride 0.12% suspension (PRED', 'Prednisolone acetate', 'Prednisolone acetate administered QID', 'DIFL or PRED']","['central corneal thickness. Non-inferior anti-inflammatory efficacy', 'intraocular pressure outcome', 'OCT-central macular thickness', 'total anterior chamber clearance', 'cell & flare, corrected distance visual acuity (CDVA), endothelial cell count, OCT-central macular thickness, and intraocular pressure (IOP', 'corneal thickness', 'endothelial cell count', 'CDVA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C2013096', 'cui_str': 'OPHTHALMOLOGICALS'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0031470', 'cui_str': 'Phenylephrine hydrochloride'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0058004', 'cui_str': 'difluprednate'}, {'cui': 'C4517411', 'cui_str': '0.05'}]","[{'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}]",259.0,0.526853,"No statistically significant differences were reported between treatments in CDVA (p = 0.455), endothelial cell count (p = 0.811), OCT-central macular thickness (p = 0.869), and in intraocular pressure outcome (p = 0.316).
","[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Valvecchia', 'Affiliation': 'Centro de Ojos Quilmes, Quilmes, Buenos Aires, Argentina Centro de Ojos Martínez, Martínez, Buenos Aires, Argentina Clínica de ojos y cirugía refractiva Dr. Carlos Ferroni, Rosario, Santa Fe, Argentina. Instituto Zaldívar, Mendoza, Mendoza, Argentina. Universidad de Buenos Aires, Facultad de Farmacia y Bioquímica, Cátedra de Matemática, Ciudad Autónoma de Buenos Aires, Argentina. Laboratorios POEN S.A.U., Ciudad Autónoma de Buenos Aires, Argentina.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kaufer', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferroni', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Zaldívar', 'Affiliation': ''}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Masseroni', 'Affiliation': ''}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Idiart', 'Affiliation': ''}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Ferroni', 'Affiliation': ''}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Marino', 'Affiliation': ''}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Nuñez', 'Affiliation': ''}, {'ForeName': 'Melina Del', 'Initials': 'MD', 'LastName': 'Papa', 'Affiliation': ''}, {'ForeName': 'María Silvia', 'Initials': 'MS', 'LastName': 'Passerini', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000863']
2725,34759153,Efficacy of the direct grasping technique using pean forceps under fluoroscopy to replace ureteral stents in women.,"Purpose : To evaluate the efficacy of the direct grasping technique using pean forceps under fluoroscopic guidance for ureteral stent replacement in women. Methods : Between April 2018 and September 2020, 28 female patients underwent ureteral stent replacements at our facility, and 184 stent replacement procedures were performed. A total of 127 stents were replaced using pean forceps under fluoroscopic guidance (pean forceps group), and 57 stents were replaced using the cystoscope (cystoscopy group). Clinical characteristics and surgical outcomes were compared between the groups. Results : All stents were successfully replaced. There was a statistically significant difference in the procedure time between the two groups (median [interquartile range], pean forceps group : 10.8 [8.2-13.9] minutes vs. cystoscopy group : 15.8 [11.1-20.9] minutes, P < 0.001). There were no intraoperative complications in either group and no difference in the incidence of postoperative complications (pean forceps group : 1.6% vs. cystoscopy group : 1.8%, P = 1.000). Fluoroscopy time was longer in the pean forceps group, although this difference was not statistically significant (pean forceps group : 38.9 [22.6-60.1] seconds vs. cystoscopy group : 33.0 [20.0-48.9] seconds, P = 0.0558). Conclusion : The direct grasping technique using pean forceps under fluoroscopy may be a beneficial alternative to cystoscopy for ureteral stent replacement in women. J. Med. Invest. 68 : 326-329, August, 2021.",2021,"Fluoroscopy time was longer in the pean forceps group, although this difference was not statistically significant (pean forceps group : 38.9 [22.6-60.1] seconds vs. cystoscopy group : 33.0 [20.0-48.9] seconds, P = 0.0558).","['ureteral stent replacement in women', 'Methods\u2005:\u2005Between April 2018 and September 2020, 28 female patients underwent ureteral stent replacements at our facility, and 184 stent replacement procedures were performed', 'women', '68 : 326-329, August, 2021']","['pean forceps under fluoroscopic guidance (pean forceps group), and 57 stents were replaced using the cystoscope (cystoscopy group', 'direct grasping technique using pean forceps under fluoroscopic guidance', 'direct grasping technique using pean forceps under fluoroscopy']","['intraoperative complications', 'incidence of postoperative complications', 'Fluoroscopy time', 'procedure time']","[{'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0522779', 'cui_str': 'Replacement of stent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C5191353', 'cui_str': '326'}]","[{'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0560563', 'cui_str': 'Fluoroscopic guidance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0180274', 'cui_str': 'Cystoscope'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]","[{'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",127.0,0.0507055,"Fluoroscopy time was longer in the pean forceps group, although this difference was not statistically significant (pean forceps group : 38.9 [22.6-60.1] seconds vs. cystoscopy group : 33.0 [20.0-48.9] seconds, P = 0.0558).","[{'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Sasaki', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ozaki', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Daizumoto', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Ueno', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Tsuda', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Kusuhara', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Fukawa', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Yasuyo', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Kunihisa', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Hiroomi', 'Initials': 'H', 'LastName': 'Kanayama', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}]",The journal of medical investigation : JMI,['10.2152/jmi.68.326']
2726,34759152,The value of Neutrophil gelatinase-associated lipocalin and Neutrophil / Lymphocyte Ratio in the diagnosis of preeclampsia and its severity.,"Many hypotheses underlie the pathogenesis of preeclampsia. This study aims to evaluate Neutrophil gelatinase-associated lipocalin (a marker of immune hypothesis) and Neutrophil / Lymphocyte ratio (a marker of inflammation) in the diagnosis of preeclampsia and its severity and to determine the correlation between them.Study design : This randomized case-control study involved 132 pregnant women ; 88 were diagnosed with PE (divided into non-severe and severe groups), and 44 healthy pregnant women as a control group. Results : The mean serum level of NGL was significantly higher in PE (535.37 ± 158.61 ng / ml for severe PE, 522.5 ± 106.3 ng / ml for non-severe PE, and 161.96 ± 17.48 ng / ml for the control group). The ROC Curve NGL criteria of more than 204.4 ng / ml showed 100% sensitivity and specificity in both severe and non-severe cases versus control. The N / L ratio showed a significant difference (5.81 ± 5.24 for severe PE, 4.1 ± 3.41 for non-severe PE, and 3.89 ± 1.79 for the control group), but the ROC curve criterion was not significant. Both showed a non-significant positive correlation. Conclusion : NGL is an excellent diagnostic factor, whereas N / L might have lower diagnostic performance compared with NGL. Both are related independently to the pathophysiology of PE. J. Med. Invest. 68 : 321-325, August, 2021.",2021,"The N / L ratio showed a significant difference (5.81 ± 5.24 for severe PE, 4.1 ± 3.41 for non-severe PE, and 3.89 ± 1.79 for the control group), but the ROC curve criterion was not significant.","['68 : 321-325, August, 2021', '132 pregnant women\u2005;\u200588 were diagnosed with PE (divided into non-severe and severe groups), and 44 healthy pregnant women as a control group']",['NGL'],['mean serum level of NGL'],"[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}]",132.0,0.114364,"The N / L ratio showed a significant difference (5.81 ± 5.24 for severe PE, 4.1 ± 3.41 for non-severe PE, and 3.89 ± 1.79 for the control group), but the ROC curve criterion was not significant.","[{'ForeName': 'Eham Amer', 'Initials': 'EA', 'LastName': 'Ali', 'Affiliation': 'Ass. Prof. Department of Chemistry and Biochemistry, College of Medicine/Mustansiriyah University, Baghdad, Iraq.'}, {'ForeName': 'Ban Hadi', 'Initials': 'BH', 'LastName': 'Hameed', 'Affiliation': 'Ass. Prof. Department of Gynaecology And Obstetrics, Mustansiriyah university\u2009\\\u2009College of medicine, Baghdad, Iraq.'}, {'ForeName': 'Alea Farhan', 'Initials': 'AF', 'LastName': 'Salman', 'Affiliation': 'Lecturer Alea Farhan Salman, The National Centre of Haematology, Mustansiriyah University, Baghdad, Iraq.'}]",The journal of medical investigation : JMI,['10.2152/jmi.68.321']
2727,34759151,"Dietary supplementation with monosodium glutamate with dietary balance such as protein, salt and sugar intake with increasing T1R3 taste receptor gene expression in healthy females.","We previously showed that chemotherapy-induced dysgeusia was associated with lingual taste receptor gene expression, and monosodium glutamate (MSG) improved dysgeusia by upregulating taste 1 receptor 3(T1R3) gene expression. In recent years, decreased taste sensitivity has also been reported in some young people, and these are partly due to their disordered eating habits. From these background, we investigated the effects of MSG supplementation on taste receptor expression and dietary intake in healthy females. Fifteen young healthy volunteers were enrolled for the present crossover study and divided in two groups (dietary supplementation with MSG at 2.7 g / day or 0.27 g / day). The relative expression of T1R3, a subunit of both umami and sweet taste receptors, in the tongue was assessed by quantitative PCR analysis. Food intake was assessed by food frequency questionnaire (FFQg), and body composition was measured using Omron HBF-701. T1R3 expression levels in the tongue and taste sensitivity increased significantly in participants who consumed <10 g of MSG daily, whereas no alteration was observed in participants who consumed >10 g of MSG daily. Furthermore, protein, fat, and carbohydrate (PFC) balance and salt and sugar intake improved by MSG supplementation. In conclusion, MSG supplementation increased T1R3 expression in the tongue and improved dietary balance. J. Med. Invest. 68 : 315-320, August, 2021.",2021,"T1R3 expression levels in the tongue and taste sensitivity increased significantly in participants who consumed <10 g of MSG daily, whereas no alteration was observed in participants who consumed >10 g of MSG daily.","['healthy females', 'Fifteen young healthy volunteers', '68 ']","['dietary supplementation with MSG', 'MSG supplementation', 'Dietary supplementation with monosodium glutamate with dietary balance such as protein, salt and sugar intake']","['taste receptor expression and dietary intake', 'taste sensitivity', 'food frequency questionnaire (FFQg), and body composition', 'dietary balance', 'Furthermore, protein, fat, and carbohydrate (PFC) balance and salt and sugar intake', 'T1R3 expression', 'Food intake', 'T1R3 expression levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0037511', 'cui_str': 'Monosodium glutamate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}]","[{'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",15.0,0.0476511,"T1R3 expression levels in the tongue and taste sensitivity increased significantly in participants who consumed <10 g of MSG daily, whereas no alteration was observed in participants who consumed >10 g of MSG daily.","[{'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Beppu', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Shono', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Ayuka', 'Initials': 'A', 'LastName': 'Kawakami', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Takashi', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Suzuno', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Akari', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kuroda', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kanamura', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ohnishi', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kondo', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Takahito', 'Initials': 'T', 'LastName': 'Azuma', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Sato', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Kitamura', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakaue', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Takeda', 'Affiliation': 'Department of Otolaryngology, Institute of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}]",The journal of medical investigation : JMI,['10.2152/jmi.68.315']
2728,34759139,"Effects of daily 1,000-IU vitamin D-fortified milk intake on skeletal muscle mass, power, physical function and nutrition status in Japanese.","An intervention study was conducted to investigate the effects of daily 1,000-IU vitamin D-fortified milk intake on skeletal muscle mass, power, physical function and nutrition status in 26 healthy people and 8 older adults living in a nursing home. The serum 25-hydroxyvitamin D [25(OH)D] level was 13.4 ± 0.8 ng / mL and it markedly increased to 29.6 ± 0.9 ng / mL after daily 1000-IU vitamin D-fortified milk intake for 6 months. Handgrip strength (kg) also significantly increased in the 21-50 years and total groups, and male subjects, and the timed up and go test significantly improved in the 21-50 years and total groups, and female subjects after 6-month vitamin D intake. However, there were no significant differences between baseline and post-treatment in the Barthel Index (BI), walking speed (m / sec) or skeletal muscle mass (kg, % of BW, kg / m2). Therefore, the present study suggested that vitamin D-fortified milk intake is effective at improving muscle strength and physical function in Japanese, although further studies are needed, particularly for older adults. J. Med. Invest. 68 : 249-255, August, 2021.",2021,"Handgrip strength (kg) also significantly increased in the 21-50 years and total groups, and male subjects, and the timed up and go test significantly improved in the 21-50 years and total groups, and female subjects after 6-month vitamin D intake.","['older adults', '68 : 249-255, August, 2021', '26 healthy people and 8 older adults living in a nursing home', 'Japanese']","['daily 1,000-IU vitamin D-fortified milk intake', 'vitamin D-fortified milk intake']","['Barthel Index (BI), walking speed (m\u2009/\u2009sec) or skeletal muscle mass', 'skeletal muscle mass, power, physical function and nutrition status', 'serum 25-hydroxyvitamin D [25(OH)D] level', 'Handgrip strength (kg']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1532525', 'cui_str': 'Fortified milk'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",26.0,0.0446517,"Handgrip strength (kg) also significantly increased in the 21-50 years and total groups, and male subjects, and the timed up and go test significantly improved in the 21-50 years and total groups, and female subjects after 6-month vitamin D intake.","[{'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Matsuura', 'Affiliation': 'Kenshokai Gakuen College for Health and Welfare, Tokushima, Japan.'}, {'ForeName': 'Teruhiro', 'Initials': 'T', 'LastName': 'Morishita', 'Affiliation': 'Kenshokai Gakuen College for Health and Welfare, Tokushima, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Kenshokai Gakuen College for Health and Welfare, Tokushima, Japan.'}, {'ForeName': 'Nami', 'Initials': 'N', 'LastName': 'Sumida', 'Affiliation': 'Kenshokai Gakuen College for Health and Welfare, Tokushima, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Katayama', 'Affiliation': 'Department of Statistics and Computer Science, College of Nursing Art and Science, University of Hyogo, Akashi, Japan.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakaue', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Taketani', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Sairyo', 'Affiliation': 'Department of Orthopedics, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Kawaura', 'Affiliation': 'Kenshokai Gakuen College for Health and Welfare, Tokushima, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Takeda', 'Affiliation': 'Kenshokai Gakuen College for Health and Welfare, Tokushima, Japan.'}]",The journal of medical investigation : JMI,['10.2152/jmi.68.249']
2729,34759131,New Ultrasound-Controlled Paclitaxel Releasing Balloon vs. Asymmetric Drug-Eluting Stent in Primary ST-Segment Elevation Myocardial Infarction　- A Prospective Randomized Trial.,"BACKGROUND


Application of drug-coated balloons (DCBs) is popular for the treatment of percutaneous coronary intervention (PCI). A new DCB has been designed as ultrasound-controlled paclitaxel releasing. This study was conducted to determine whether a DCB-only strategy has a similar safety profile and equal angiographic and clinical outcomes to DES implantation in primary ST-elevation myocardial infarction (STEMI) patients, as well as determine the efficiency and safety of this new DCB.Methods and Results:Overall, 184 pretreated STEMI patients were randomized into DCB and DES groups with a 1:1 allocation. The main study end-point was late lumen loss (LLL) during the 9 months after PCI. Late lumen loss was reported to be 0.24±0.39 mm in the DCB group and 0.31±0.38 mm in the DES group (P=0.215). Diameter stenosis was 28.27±15.35% in the DCB group and 25.73±15.41% in the DES group (P=0.312). Major adverse cardiovascular events (MACEs) were reported in 3 patients (3.4%) in the DCB group and 4 patients (4.7%) in the DES group (P=0.718). TLR and TVR in the DCB group was 2.3%, 3.4% and 2.4%, 3.5% in the DES group (P=1.000), respectively. No cardiac death and stent thrombosis (ST) was found in the DCB group at 12 months clinical follow up.
CONCLUSIONS


The DCB-only strategy showed good angiographic and clinical outcomes in the 9- and 12-month follow-up periods, respectively. The VasoguardTM DCB is safe and feasible to treat STEMI patients.",2021,"The DCB-only strategy showed good angiographic and clinical outcomes in the 9- and 12-month follow-up periods, respectively.","['primary ST-elevation myocardial infarction (STEMI) patients', '184 pretreated STEMI patients']","['DES implantation', 'New Ultrasound-Controlled Paclitaxel Releasing Balloon vs. Asymmetric Drug-Eluting Stent', 'drug-coated balloons (DCBs', 'VasoguardTM DCB', 'DCB']","['cardiac death and stent thrombosis (ST', 'Major adverse cardiovascular events (MACEs', 'Late lumen loss', 'TLR and TVR', 'Diameter stenosis', 'late lumen loss (LLL']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517616', 'cui_str': '184'}]","[{'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0000370', 'cui_str': ""3-3'dichlorobenzidine""}]","[{'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]",184.0,0.065621,"The DCB-only strategy showed good angiographic and clinical outcomes in the 9- and 12-month follow-up periods, respectively.","[{'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Emergency Cardiology, Heart Center, Inner Mongolia People's Hospital.""}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Beijing Advanced Innovation Center for Materials Genome Engineering, University of Science and Technology Beijing.'}, {'ForeName': 'Jianfei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Emergency Cardiology, Heart Center, Inner Mongolia People's Hospital.""}, {'ForeName': 'Wantao', 'Initials': 'W', 'LastName': 'Qi', 'Affiliation': ""Department of Emergency Cardiology, Heart Center, Inner Mongolia People's Hospital.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': ""Department of Emergency Cardiology, Heart Center, Inner Mongolia People's Hospital.""}, {'ForeName': 'Zhiru', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of Emergency Cardiology, Heart Center, Inner Mongolia People's Hospital.""}, {'ForeName': 'Wangliang', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': ""Department of Emergency Cardiology, Heart Center, Inner Mongolia People's Hospital.""}, {'ForeName': 'Fa', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""Department of Emergency Cardiology, Heart Center, Inner Mongolia People's Hospital.""}, {'ForeName': 'Mingkun', 'Initials': 'M', 'LastName': 'Cao', 'Affiliation': ""Department of Vascular & Intervention, Tenth Peoples' Hospital of Tongji University, Tongji University.""}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Vascular & Intervention, Tenth Peoples' Hospital of Tongji University, Tongji University.""}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-21-0315']
2730,34759112,Intake of Docosahexaenoic Acid-Enriched Milk Beverage Prevents Age-Related Cognitive Decline and Decreases Serum Bone Resorption Marker Levels.,"The pathogenic mechanism of dementia is still unknown, and the fundamental treatment remains to be established. Thus, there is growing interest in preventing dementia through diet. One of the functional ingredients attracting attention is docosahexaenoic acid. We conducted a 12-month, randomized, double-blind, placebo-controlled clinical trial in healthy elderly Japanese individuals with a Mini-Mental State Examination score of 28 or higher at baseline using a docosahexaenoic acid-enriched milk beverage containing 297 mg docosahexaenoic acid and 137 mg eicosapentaenoic acid. Consumption of a docosahexaenoic acid-enriched milk beverage increased the fatty acid levels of docosahexaenoic acid and eicosapentaenoic acid in erythrocyte membranes, which was the primary outcome of this study. Moreover, intake of this beverage prevented age-related cognitive decline and decreased serum bone resorption marker levels. Our data demonstrate that, even at a low dose, long-term daily intake of docosahexaenoic acid prevents dementia and may show beneficial effect on bone health.",2021,"Moreover, intake of this beverage prevented age-related cognitive decline and decreased serum bone resorption marker levels.",['healthy elderly Japanese individuals with a Mini-Mental State Examination score of 28 or higher at baseline using a'],"['Docosahexaenoic Acid-Enriched Milk Beverage', 'docosahexaenoic acid-enriched milk beverage containing 297 mg docosahexaenoic acid and 137 mg eicosapentaenoic acid', 'docosahexaenoic acid', 'docosahexaenoic acid-enriched milk beverage', 'placebo']","['serum bone resorption marker levels', 'Serum Bone Resorption Marker Levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.230096,"Moreover, intake of this beverage prevented age-related cognitive decline and decreased serum bone resorption marker levels.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ichinose', 'Affiliation': 'Research Institute for Creating the Future, Fuji Oil Holdings Inc.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Matsuzaki', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'R&D Division, Fuji Oil Co., Ltd.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Tanabe', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Tachibana', 'Affiliation': 'Research Institute for Creating the Future, Fuji Oil Holdings Inc.'}, {'ForeName': 'Miwako', 'Initials': 'M', 'LastName': 'Morikawa', 'Affiliation': 'R&D Division, Fuji Oil Co., Ltd.'}, {'ForeName': 'Setsushi', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Kato Hospital, Jinjukai Healthcare Corporation.'}, {'ForeName': 'Shuuzo', 'Initials': 'S', 'LastName': 'Ohata', 'Affiliation': 'Kato Hospital, Jinjukai Healthcare Corporation.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Ohno', 'Affiliation': 'Kato Hospital, Jinjukai Healthcare Corporation.'}, {'ForeName': 'Harumi', 'Initials': 'H', 'LastName': 'Wakatsuki', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine.'}, {'ForeName': 'Shahdat', 'Initials': 'S', 'LastName': 'Hossain', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Shido', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine.'}]",Journal of oleo science,['10.5650/jos.ess21195']
2731,34759577,The effect of natural reducing agents on push-out bond strength of AH plus and BioRoot RCS to sodium hypochlorite treated root dentin.,"Aims


To evaluate the effect of natural anticoagulants 6.5% proanthocyanidin (PA) and 25% bamboo salt on push-out bond strength (PBS) of AH Plus and BioRoot RCS to dentin.
Subjects and Methods


30 single-rooted extracted human teeth were collected. After establishing the working length samples were prepared up to size F3. 5 ml of 3% NaOCl was used as irrigant during instrumentation followed by rinse with 5 ml of 17% ethylenediaminetetraacetic acid. Samples were randomly divided into groups based on the final irrigation solution: Group I - AH plus sealer group, Ia - Saline group, Ib - PA group, Ic - Bamboo salt (BS) group. Group II - BioRoot RCS group, IIa - Saline group, IIb - PA group, IIc - BS group. After obturation, samples were embedded in self-cure acrylic resin and 2 mm thick root slices were made at coronal middle and apical 3 rd . These slices were subjected to PBS testing followed by stereomicroscopic examination for checking the mode of failure.
Statistical Analysis Used


Kruskal-Wallis and Dunn's  post hoc  test.
Results


3% NaOCl significantly decreased the bond strength of AH Plus as compared to BioRoot RCS to dentin ( P  < 0.05). Both PA and BS were capable of increasing the PBS of AH Plus and BioRoot RCS to NaOCl-treated dentin.
Conclusions


Final irrigation with antioxidants such as PA and BS eliminates the risk of reduced bond strength of sealer to root canal walls, which ensues following the use of NaOCl as an irrigant.",2021,"Both PA and BS were capable of increasing the PBS of AH Plus and BioRoot RCS to NaOCl-treated dentin.
",['Subjects and Methods\n\n\n30 single-rooted extracted human teeth were collected'],"['ethylenediaminetetraacetic acid', 'AH plus sealer group, Ia - Saline group, Ib - PA group, Ic - Bamboo salt (BS', 'natural anticoagulants 6.5% proanthocyanidin (PA) and 25% bamboo salt']",['bond strength of AH Plus'],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0072018', 'cui_str': 'Proanthocyanidin'}, {'cui': 'C4277450', 'cui_str': 'bamboo salt'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C3844007', 'cui_str': '6.5'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}]",30.0,0.0184203,"Both PA and BS were capable of increasing the PBS of AH Plus and BioRoot RCS to NaOCl-treated dentin.
","[{'ForeName': 'S Mann', 'Initials': 'SM', 'LastName': 'Navjot', 'Affiliation': 'Professor and Head, Department of Conservative Dentistry and Endodontics, National Dental College and Hospital, Punjab, India.'}, {'ForeName': 'Jhamb', 'Initials': 'J', 'LastName': 'Ashu', 'Affiliation': 'Reader, Department of Conservative Dentistry and Endodontics, National Dental College and Hospital, Punjab, India.'}, {'ForeName': 'Kaur', 'Initials': 'K', 'LastName': 'Kamalpreet', 'Affiliation': 'PG Student, Department of Conservative Dentistry and Endodontics, National Dental College and Hospital, Punjab, India.'}, {'ForeName': 'K Mann', 'Initials': 'KM', 'LastName': 'Navneet', 'Affiliation': 'Reader, Department of Prosthodontics, National Dental College and Hospital, Punjab, India.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Manu', 'Affiliation': 'Reader, Department of Conservative Dentistry and Endodontics, National Dental College and Hospital, Punjab, India.'}, {'ForeName': 'Batra', 'Initials': 'B', 'LastName': 'Divya', 'Affiliation': 'Senior Lecturer, Department of Conservative Dentistry and Endodontics, National Dental College and Hospital, Punjab, India.'}]",Journal of conservative dentistry : JCD,['10.4103/jcd.jcd_52_21']
2732,34759565,Determination of the efficacy of ultrasound-guided bilateral transversus abdominis plane (US-TAP) block in laparoscopic total extraperitoneal (TEP) repair of unilateral hernia surgeries: A randomized controlled trial.,"Background and Aims


Bilateral ultrasound-guided transversus abdominis plane (US-TAP) block has been successfully used to provide analgesia for most lower abdominal procedures. Our aim was to determine the efficacy of US-TAP block with levobupivacaine in laparoscopic total extraperitoneal (TEP) repair of unilateral hernia surgeries under general anaesthesia (GA) as compared to no block.
Material and Methods


It is prospective randomised controlled study done in a tertiary care centre in South-East Asia. After obtaining Institute Ethics Committee approval and consent, 60 patients of ASA I-II aged between 18 to 80 years were randomized into two groups.After receiving GA, Group TAP - received bilateral US-TAP block with levobupivacaine 0.25% 0.3ml kg -1  on either side whereas, the control group did not receive any block.The time taken to first request for rescue analgesic (T Rescue) by the patient and the Numeric Rating Scale (NRS) at that time point were noted and tramadol 50mg i.v. was administered, followed by 50mg i.m. PRN for 24 h from the time of extubation. The 24 h analgesic requirement was noted in mg kg -1 .
Results


Results were analysed using SPSS 16 and  P < 0.05  was considered significant. T Rescue was significantly longer in the TAP Group ( P = 0.02 ) with lower NRS at time points 24 h ( P = 0.02 ) and 12 h ( P = 0.004 ). Postoperative nausea and vomiting were significantly less in TAP Group ( P < 0.001 ).
Conclusion


Bilateral US-TAP block provided better analgesia and side effect profile as compared to no block when administered in laparoscopic TEP repair of hernia surgeries.",2021,T Rescue was significantly longer in the TAP Group ( P = 0.02 ) with lower NRS at time points 24 h ( P = 0.02 ) and 12 h ( P = 0.004 ).,"['60 patients of ASA I-II aged between 18 to 80 years', 'unilateral hernia surgeries', 'tertiary care centre in South-East Asia']","['levobupivacaine', 'laparoscopic total extraperitoneal (TEP) repair of unilateral hernia surgeries under general anaesthesia (GA', 'ultrasound-guided bilateral transversus abdominis plane (US-TAP) block', 'Bilateral ultrasound-guided transversus abdominis plane (US-TAP) block', 'TAP', 'laparoscopic total extraperitoneal (TEP) repair', 'tramadol']","['Postoperative nausea and vomiting', 'Numeric Rating Scale (NRS', 'analgesic requirement', 'T Rescue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0003983', 'cui_str': 'South east Asian country'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",,0.500545,T Rescue was significantly longer in the TAP Group ( P = 0.02 ) with lower NRS at time points 24 h ( P = 0.02 ) and 12 h ( P = 0.004 ).,"[{'ForeName': 'Vijayalakshmi', 'Initials': 'V', 'LastName': 'Sivapurapu', 'Affiliation': 'Department of Anesthesiology, Indira Gandhi Medical College and Research Institute, Puducherry, India.'}, {'ForeName': 'Sri Vengadesh', 'Initials': 'SV', 'LastName': 'Gopal', 'Affiliation': 'Department of General Surgery, Indira Gandhi Medical College and Research Institute, Puducherry, India.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'Department of General Surgery, Indira Gandhi Medical College and Research Institute, Puducherry, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_353_19']
2733,34759564,A study to evaluate the role of experience in acquisition of the skill of orotracheal intubation in adults.,"Background and Aims


To evaluate the role of experience in acquisition of skill of orotracheal intubation in adults.
Material and Methods


A prospective randomized study was conducted on 307 patients of either sex, belonging to ASA grade I and II (aged 18-60 years) posted for surgery under general anaesthesia. The patients were subjected to DL and ETI procedure, which was performed by five different groups of participants. Group 1 consisted of first-year resident of anaesthesiology with experience of less than 10 intubations, group 2 for second-year resident, group 3 for third-year resident, group 4 for senior resident and group 5 for consultant. Ease of mask ventilation, time taken for intubation, number of attempts, success rate, and ease of intubation were assessed for all the groups.
Results


Categorical variables were analysed using Chi-square test. For all statistical tests, a  P  value less than 0.05 was taken as a significant difference. Maximum difficulty in mask ventilation was encountered by group 1 anaesthesiologist, that is, in 69.2% of the patients. Group 1 took maximum time to intubate, that is, 47.98 ± 31.54 sec and least time was taken by group 5 anaesthesiologist (9.55 ± 6.93) sec. First attempt success rate was least in group (80.0%). Group 1 had success rate of 96.9%, whereas rest all groups had 100% success.
Conclusion


Skill of mask ventilation and intubation and time taken for intubation grossly improves with increasing experience. Minimum of 25 intubation attempts should be required by an anaesthesiologist resident in elective scenario to achieve 100% success rate in our study.",2021,First attempt success rate was least in group (80.0%).,"['adults', 'I and II (aged 18-60 years) posted for surgery under general anaesthesia', '307 patients of either sex, belonging to ASA grade']",[],"['Ease of mask ventilation, time taken for intubation, number of attempts, success rate, and ease of intubation', 'Maximum difficulty in mask ventilation', 'success rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",[],"[{'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",307.0,0.0147123,First attempt success rate was least in group (80.0%).,"[{'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Singhal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Kiranpreet', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Pushpa', 'Initials': 'P', 'LastName': 'Yadav', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_133_19']
2734,34759559,Intraperitoneal nebulization of ropivacaine for control of pain after laparoscopic cholecystectomy -A randomized control trial.,"Background and Aims


Use of high dose opioids following laparoscopic surgery delays discharge from the hospital. Unlike intraperitoneal instillation, nebulization has been reported to provide a homogeneous spread of local anesthetics and provide better analgesia. In our study, we aimed to assess the efficacy of intraperitoneal nebulization of local anesthetic in alleviating postoperative pain in patients undergoing laparoscopic cholecystectomy.
Material and Methods


This randomized control double-blinded study was conducted after obtaining approval from the hospital ethics committee and informed consent from patients undergoing laparoscopic cholecystectomy under general anesthesia. Patients recruited were divided into two equal groups of 20 each. Group B received intraperitoneal nebulization with 4 ml of 0.75% ropivacaine and Group C received intraperitoneal nebulization with 4ml of saline before surgical dissection. Postoperative pain score using a numeric rating scale was monitored until 24 h, the need for rescue analgesics and associated complications were noted. Chi-square test, Student's test, and Mann-Whitney  U  test were used for statistical analysis.
Results


The pain score was significantly less in Group B during rest and deep breathing up to 24 h with a  P  value <0.05. The pain score on movement was also less in Group B and this difference was statistically significant at 6 and 24 h ( P  = 0.004 and 0.005, respectively). Tramadol consumption was less in Group B and was statistically significant at 24 h with  P  value of 0.044. No adverse events were noted.
Conclusion


Intraperitoneal nebulization of ropivacaine is effective and safe in providing postoperative analgesia in patients undergoing laparoscopic cholecystectomy.",2021,Tramadol consumption was less in Group B and was statistically significant at 24 h with  P  value of 0.044.,"['laparoscopic surgery delays discharge from the hospital', 'patients undergoing laparoscopic cholecystectomy', 'patients undergoing laparoscopic cholecystectomy under general anesthesia']","['ropivacaine', 'intraperitoneal nebulization of local anesthetic', 'intraperitoneal nebulization with 4 ml of 0.75% ropivacaine', 'intraperitoneal nebulization with 4ml of saline before surgical dissection']","['adverse events', 'pain score on movement', 'numeric rating scale', 'Postoperative pain score', 'pain score', 'Tramadol consumption']","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.103138,Tramadol consumption was less in Group B and was statistically significant at 24 h with  P  value of 0.044.,"[{'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Sandhya', 'Affiliation': 'Department of Anaesthesia and Critical Care, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Nitu', 'Initials': 'N', 'LastName': 'Puthenveettil', 'Affiliation': 'Department of Anaesthesia and Critical Care, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Vinodan', 'Affiliation': 'Department of Anaesthesia and Critical Care, Medical Trust Hospital Kochi, Kerala, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_358_19']
2735,34759557,Comparison of clinical methods to diagnose pediatric endobronchial intubation-A randomized controlled trial.,"Background and Aims


Diagnosing accurate placement of the tip of the endotracheal tube is crucial in pediatric practice. This study was conducted to find out the efficacy of five clinical methods to ascertain the tube position by a resident anesthesiologist.
Material and Methods


This was a randomized crossover study conducted in a research institute. Fifty pediatric patients were enrolled. All patients were randomly allocated to tracheal (group T) or bronchial group (group B). The five clinical methods which were evaluated include the auscultation, observation of chest movements, bag compliance, tube depth, and capnography. In group T, the tube was placed in the trachea and later positioned in bronchus (assisted by fiberoptic bronchoscopy). The vice versa was done in group B. In each position, a single test followed by all tests was performed and after the change of position, the same single test followed by all tests was performed. Correct and incorrect diagnoses by tests in detecting tube positions were made and their sensitivity and odds ratio were estimated.
Results


The tube depth and combination of all tests detected endobronchial intubation with a sensitivity of 88% and 97%, respectively, which is more than that of auscultation (70%) and observation (55%). Evaluation of the difference in agreement level of tube depth to detect tube-position showed the odds ratio of 2.28 (0.17-30.95) for detecting endobronchial intubation.
Conclusion


We observed that the tube-depth was better than the other individual tests in diagnosing endobronchial intubation in pediatric patients. However, its efficacy is lesser than that of performing all clinical tests together.",2021,"The tube depth and combination of all tests detected endobronchial intubation with a sensitivity of 88% and 97%, respectively, which is more than that of auscultation (70%) and observation (55%).","['Fifty pediatric patients were enrolled', 'pediatric patients']",[],"['auscultation, observation of chest movements, bag compliance, tube depth, and capnography']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0231896', 'cui_str': 'Chest movement'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0376529', 'cui_str': 'Capnography'}]",50.0,0.0540094,"The tube depth and combination of all tests detected endobronchial intubation with a sensitivity of 88% and 97%, respectively, which is more than that of auscultation (70%) and observation (55%).","[{'ForeName': 'Sathishkumar', 'Initials': 'S', 'LastName': 'Selvaraj', 'Affiliation': 'Department of Anesthesiology and Critical Care, Kauvery Hospital, Salem, Tamil Nadu, India.'}, {'ForeName': 'Lenin Babu', 'Initials': 'LB', 'LastName': 'Elakkumanan', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Education and Research, Puducherry, India.'}, {'ForeName': 'Hemavathy', 'Initials': 'H', 'LastName': 'Balachandar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Education and Research, Puducherry, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_272_19']
2736,34759556,The interrelation between body mass index and post-dural puncture headache in parturient women.,"Background and Aims


Post-dural puncture headache is seen more frequently in pregnant women due to stress, dehydration, intra-abdominal pressure, and insufficient fluid replacement after delivery. Obesity protects against post-dural puncture headache in pregnant women; increased intra-abdominal fat tissue reduced cerebrospinal fluid leakage by increasing the pressure in the epidural space. Therefore, this study investigated the influence of body mass index on post-dural puncture headache in elective cesarean section patients in whom 27G spinal needles were used.
Material and Methods


The study included 464 women who underwent elective cesarean section under spinal anesthesia. Dural puncture performed with a 27G Quincke spinal needle at the L3-4 or L4-5 intervertebral space and given 12.5 mg hyperbaric bupivacaine intrathecally. The patients were questioned regarding headache and low back pain 6, 12, 24, and 48 h after the procedure, and by phone calls on days 3 and 7.
Results


Post-dural puncture headache developed in 38 (8.2%) patients. Of the patients who developed post-dural puncture headache, 23 (60.5%) had a body mass index <30 and 15 (39.5%) had a body mass index ≥30. Of the patients who did not develop post-dural puncture headache, 258 (60, 6%) had a body mass index <30 and 168 (39, 4%) had a body mass index ≥30.
Conclusion


This prospective study found the body mass index values did not affect post-dural puncture headache in the elective cesarean section performed under spinal anesthesia.",2021,Obesity protects against post-dural puncture headache in pregnant women; increased intra-abdominal fat tissue reduced cerebrospinal fluid leakage by increasing the pressure in the epidural space.,"['patients who developed post-dural puncture headache, 23 (60.5%) had a body mass index <30 and 15 (39.5%) had a body mass index ≥30', '464 women who underwent elective cesarean section under spinal anesthesia', 'parturient women', 'patients who did not develop post-dural puncture headache, 258 (60, 6%) had a body mass index <30 and 168 (39, 4%) had a body mass index ≥30', 'pregnant women', 'elective cesarean section patients in whom 27G spinal needles were used']","['Obesity protects against post-dural puncture headache', 'Dural puncture performed with a 27G Quincke spinal needle at the L3-4 or L4-5 intervertebral space and given 12.5 mg hyperbaric bupivacaine', 'elective cesarean section performed under spinal anesthesia']",['Results\n\n\nPost-dural puncture headache'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0456640', 'cui_str': '27G'}, {'cui': 'C0181982', 'cui_str': 'Spinal needle'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0456640', 'cui_str': '27G'}, {'cui': 'C1301823', 'cui_str': 'Quincke spinal needle'}, {'cui': 'C0223088', 'cui_str': 'Structure of intervertebral space'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}]",464.0,0.0289484,Obesity protects against post-dural puncture headache in pregnant women; increased intra-abdominal fat tissue reduced cerebrospinal fluid leakage by increasing the pressure in the epidural space.,"[{'ForeName': 'Serbülent Gökhan', 'Initials': 'SG', 'LastName': 'Beyaz', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Faculty of Medicine, Istinye University, Istanbul, Republic of Turkey.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Ergönenç', 'Affiliation': 'Department of Anesthesiology, Akyazı State Hospital, Sakarya, Republic of Turkey.'}, {'ForeName': 'Aykut', 'Initials': 'A', 'LastName': 'Saritaş', 'Affiliation': 'Department of Anesthesiology and Reanimation, Tepecik Training and Research Hospital, İzmir, Republic of Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Şahin', 'Affiliation': 'Department of Anesthesiology, Yenikent State Hospital, Sakarya, Republic of Turkey.'}, {'ForeName': 'Ali Metin', 'Initials': 'AM', 'LastName': 'Ülgen', 'Affiliation': 'Department of Anesthesiology, Sakarya University Training and Research Hospital, Sakarya, Republic of Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Eman', 'Affiliation': 'Department of Anesthesiology, Sakarya University Training and Research Hospital, Sakarya, Republic of Turkey.'}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Doğan', 'Affiliation': 'Department of Family Medicine, Sakarya University Training and Research Hospital, Sakarya, Republic of Turkey.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_249_19']
2737,34759555,Efficacy of Baska mask as an alternative airway device to endotracheal tube in patients undergoing laparoscopic surgeries under controlled ventilation.,"Background and Aims


Newer supraglottic devices with an additional gastric channel offer greater protection from aspiration and avoidance of laryngoscopy for their insertion would result in attenuated hemodynamic responses.The primary objective was to assess hemodynamic responses to insertion of Baska mask as compared to tracheal intubation. The time and attempts taken to secure airway and evidence of regurgitation and pulmonary aspiration of gastric contents were also assessed.
Material and Methods


This prospective, randomized study was conducted in 80 patients undergoing laparoscopic cholecystectomy. All patients received standardized anaesthesia protocol. Baska mask was used to secure airway in Group B, while tracheal intubation was done in group T. Methylene blue was injected through Ryle's tube into stomach in both groups. At end of surgery, fibreoptic bronchoscopy was performed to detect bluish staining of trachea and/or main bronchi as evidence of aspiration of gastric contents and bluish staining in oropharynx as evidence of regurgitation. Chi-square test and Independent sample t-test were applied.
Results


The time taken to secure airway was significantly longer in Group B as compared to Group T (45.3 ± 12.6 vs. 24.3 ± 9.1 sec) Percentage of patients who had oropharyngeal blue stain was comparable in both groups. No patient in both groups had tracheal blue stain. Group T had significantly higher HR and MAP after intubation till 10 min later.
Conclusion


Baska mask insertion was associated with attenuated hemodynamic responses, though more time and attempts were required for securing the airway. It could be considered as an alternative to tracheal intubation during laparoscopic surgeries.",2021,The time taken to secure airway was significantly longer in Group B as compared to Group T (45.3 ± 12.6 vs. 24.3 ± 9.1 sec),"['patients undergoing laparoscopic surgeries under controlled ventilation', '80 patients undergoing']","['laparoscopic cholecystectomy', 'standardized anaesthesia protocol', 'Baska mask']","['oropharyngeal blue stain', 'HR and MAP', 'hemodynamic responses', 'tracheal blue stain', 'hemodynamic responses to insertion of Baska mask', 'time and attempts taken to secure airway and evidence of regurgitation and pulmonary aspiration of gastric contents', 'time taken to secure airway']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0419011', 'cui_str': 'Controlled ventilation'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0004052', 'cui_str': 'Pulmonary aspiration of gastric contents'}]",80.0,0.0136034,The time taken to secure airway was significantly longer in Group B as compared to Group T (45.3 ± 12.6 vs. 24.3 ± 9.1 sec),"[{'ForeName': 'Pulak', 'Initials': 'P', 'LastName': 'Tosh', 'Affiliation': 'Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Patna, India.'}, {'ForeName': 'Ravi B', 'Initials': 'RB', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Patna, India.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Sahay', 'Affiliation': 'Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Patna, India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Suman', 'Affiliation': 'Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Patna, India.'}, {'ForeName': 'Umesh K', 'Initials': 'UK', 'LastName': 'Bhadani', 'Affiliation': 'Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Patna, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_339_19']
2738,34759551,What is the minimum effective anesthetic volume (MEAV90) of 0.2% ropivacaine required for ultrasound-guided popliteal-sciatic nerve block?,"Background and Aims


Popliteal-Sciatic nerve block under Ultrasound Guidance (USG) using a local anesthetic agent like Ropivacaine is an established technique for providing analgesia and muscle relaxation for lower limb surgeries with minimal untoward events. Establishing the minimal volume of 0.2% ropivacaine required to provide intraoperative and postoperative analgesia will further reduce the drug requirements and adverse effects toward the patient.
Material and Methods


This randomized prospective observational blinded study was done in a tertiary care referral hospital in South India over 9 months from August 2017 till April 2018. The block was performed on all recruited patients under ultrasound guidance with a starting volume of 16 ml 0.2% ropivacaine. Duration of time for loss of pin-prick sensation around the sole of the foot (tibial nerve) and the lateral malleolus (common peroneal nerve) was noted. If successful, the volume of the drug for subsequent patients was randomized by lottery method to either be kept the same or reduced. If the block failed, the subsequent patient recruited would have an increased volume of drug injected.
Results


By Probit regression analysis using the biased coin up-and-down method we found that 9.3 ml (MEAV90) of 0.2% ropivacaine was sufficient for providing adequate analgesia. Factors such as patient age or weight had no role in efficacy of the block. There were no adverse effects such as allergy to the drug or systemic toxicity noted in the studied patients.
Conclusion


9.3 ml of 0.2% ropivacaine is sufficient to provide analgesia (assessed by pin-prick) in 90% of patients undergoing popliteal-sciatic block for lower limb surgeries.",2021,"There were no adverse effects such as allergy to the drug or systemic toxicity noted in the studied patients.
",['tertiary care referral hospital in South India over 9 months from August 2017 till April 2018'],"['Popliteal-Sciatic nerve block under Ultrasound Guidance (USG', 'ropivacaine', 'ultrasound guidance with a starting volume of 16 ml 0.2% ropivacaine', 'Ropivacaine']","['adverse effects such as allergy to the drug or systemic toxicity', 'Duration of time for loss of pin-prick sensation']","[{'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4552199', 'cui_str': 'Systemic toxicity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0423557', 'cui_str': 'Discrimination between sharp and blunt'}]",,0.0697319,"There were no adverse effects such as allergy to the drug or systemic toxicity noted in the studied patients.
","[{'ForeName': 'Sandeep N', 'Initials': 'SN', 'LastName': 'David', 'Affiliation': 'Department of Anaesthesiology, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.'}, {'ForeName': 'Davies C', 'Initials': 'DC', 'LastName': 'Varghese', 'Affiliation': 'Department of Anaesthesiology, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Valiaveedan', 'Affiliation': 'Department of Anaesthesiology, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_34_19']
2739,34759548,Efficacy of dexmedetomidine as an adjuvant in femoral nerve block for post-op pain relief in hip surgery: A prospective randomized double-blind controlled study.,"Background and Aims


To determine whether the addition of dexmedetomidine either in peripheral block or via systemic route leads to prolongation of the duration of analgesia is inconclusive. The present study aimed to assess the duration of postoperative analgesia with dexmedetomidine used as an additive with bupivacaine for ultrasound-guided femoral nerve block (FNB) and to compare it with intramuscular dexmedetomidine along with FNB.
Material and Methods


A prospective, double-blind randomized clinical trial involving adult patients undergoing elective hip surgery, performed under subarachnoid block. When sensory block receded to T12 after the surgery, FNB was given for postoperative analgesia. Patients were randomized into three groups; Group A received FNB with 40 mL 0.25% bupivacaine and 0.5 mL saline as IM injection, Group B received FNB with 39.5 mL of 0.25% bupivacaine + 0.5 mL (50 mcg) of dexmedetomidine in the affected limb and 0.5 mL saline IM injection, and Group C received FNB with 40 mL of 0.25% bupivacaine and 0.5 mL (50 mcg) of dexmedetomidine as IM injection. Postoperative pain was assessed and for pain with VAS score >3, intravenous tramadol was given as rescue analgesia. Chi-square test for categorical variables and one-way ANOVA for continuous variables.
Results


The mean duration of analgesia in groups A, B, and C was 671, 676, and 490 min, respectively which was not significant. A 24 h analgesic requirement was also not different between the groups.
Conclusion


The use of dexmedetomidine perineurally or systemically did not prolong the duration of analgesia as compared to bupivacaine alone for femoral nerve block.",2021,The use of dexmedetomidine perineurally or systemically did not prolong the duration of analgesia as compared to bupivacaine alone for femoral nerve block.,"['adult patients undergoing elective hip surgery, performed under subarachnoid block', 'hip surgery']","['FNB with 40 mL of 0.25% bupivacaine', 'FNB with 39.5 mL of 0.25% bupivacaine + 0.5 mL', 'dexmedetomidine', 'bupivacaine', 'tramadol', 'FNB', 'FNB with 40 mL 0.25% bupivacaine and 0.5 mL saline']","['duration of analgesia', 'Postoperative pain', 'mean duration of analgesia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.375935,The use of dexmedetomidine perineurally or systemically did not prolong the duration of analgesia as compared to bupivacaine alone for femoral nerve block.,"[{'ForeName': 'Chetna P', 'Initials': 'CP', 'LastName': 'Goel', 'Affiliation': 'Department of Anesthesia, SDM College of Medical Sciences and Hospital, Sattur, Dharwad, Karnataka, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Department of Anesthesia, SDM College of Medical Sciences and Hospital, Sattur, Dharwad, Karnataka, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_182_19']
2740,34759549,"Comparison between caudal epidural and ultrasound-guided ilioinguinal-iliohypogastric block with bupivacaine and dexmedetomidine for postoperative analgesia following pediatric inguinal hernia surgeries: A prospective randomized, double-blind study.","Background and Aims


Caudal epidural and ultrasound-guided ilioinguinal, iliohypogastric nerve (IL/IH) blocks are commonly used regional anesthesia techniques for postoperative analgesia in pediatric inguinal surgeries. Dexmedetomidine as an adjuvant has been proven to prolong the duration of both neuraxial and peripheral nerve blocks. We compared the duration of analgesia provided by local anesthetic (LA) and dexmedetomidine for caudal and IL/IH block for pediatric inguinal surgeries.
Material and Methods


Forty-six children undergoing inguinal hernia repair were selected for this randomized double-blind study. After general anesthesia, children received either 0.75 mL.kg -1  of 0.25% bupivacaine with 1 mcg.kg -1  of dexmedetomidine in caudal epidural or 0.25 mL.kg -1  of 0.25% bupivacaine with 1 mcg.kg -1  of dexmedetomidine in IL/IH block. The pain was assessed up to 24 h postoperatively using face, legs, activity, cry, consolability (FLACC) score. For FLACC ≥4, rescue analgesia was provided using 1 μg/kg of intravenous fentanyl, up to 2 h postoperatively and 10 mg/kg of oral ibuprofen between 2 and 24 postoperative hours. The time for first rescue analgesia was taken as the duration of analgesia.
Results


There were no significant differences in the pain scores or analgesic utilization between the groups. The duration of analgesia of caudal and IL/IH blocks was similar (720.3 ± 430.1 min and 808.4 ± 453.1 min, respectively). The time taken for the performance of block was significantly higher for caudal compared to IL/IH (547 ± 93 vs. 317 ± 179 s;  P  < 0.001).
Conclusion


Both caudal epidural and USG-IL/IH block with dexmedetomidine as additive provide the comparable duration of postoperative analgesia with no significant side effects.",2021,There were no significant differences in the pain scores or analgesic utilization between the groups.,"['pediatric inguinal surgeries', 'pediatric inguinal hernia surgeries', 'Material and Methods\n\n\nForty-six children undergoing inguinal hernia repair']","['Dexmedetomidine', 'local anesthetic (LA) and dexmedetomidine', 'dexmedetomidine', 'Caudal epidural and ultrasound-guided ilioinguinal, iliohypogastric nerve (IL/IH) blocks', 'oral ibuprofen', 'bupivacaine', 'caudal epidural and ultrasound-guided ilioinguinal-iliohypogastric block with bupivacaine and dexmedetomidine']","['duration of analgesia of caudal and IL/IH blocks', 'face, legs, activity, cry, consolability (FLACC) score', 'pain', 'time taken for the performance of block', 'pain scores or analgesic utilization']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0228903', 'cui_str': 'Structure of iliohypogastric nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0394767', 'cui_str': 'Local anesthetic block of iliohypogastric nerve'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",46.0,0.507215,There were no significant differences in the pain scores or analgesic utilization between the groups.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Varsha', 'Affiliation': 'Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharawd, Karnataka, India.'}, {'ForeName': 'Sameer N', 'Initials': 'SN', 'LastName': 'Desai', 'Affiliation': 'Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharawd, Karnataka, India.'}, {'ForeName': 'Mahantesh S', 'Initials': 'MS', 'LastName': 'Mudakanagoudar', 'Affiliation': 'Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharawd, Karnataka, India.'}, {'ForeName': 'Venkatesh M', 'Initials': 'VM', 'LastName': 'Annigeri', 'Affiliation': 'Department of Paediatric Surgery, SDM College of Medical Sciences and Hospital, Dharawd, Karnataka, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_175_19']
2741,34759547,Fentanyl versus nalbuphine for intubating conditions during awake fiberoptic bronchoscopy: A randomized double-blind comparative study.,"Background and Aims


Patient cooperation, sedation, anxiolysis, and topicalization are important prerequisites for the successful and safe conduct of awake intubation. Because of the pharmacological properties, opioids can facilitate this process. Fentanyl is an opioid agonist and nalbuphine is an agonist-antagonist. This study aims to compare these two opioids for their effect on sedation and intubating conditions during awake fiberoptic intubation.
Material and Methods


This randomized double-blind controlled study was conducted on 62 ASA I/II patients of either sex between the age of 20 and 60 years, weight between 40 and 80 kg, with MP class I/II airways requiring general anesthesia with endotracheal intubation. All patients received standard airway topicalization and nebulization. Patients were randomly allocated to one of the two groups according to a computer-generated random number table. Group F ( n  = 31) received fentanyl 2 μg/kg i.v. and group N ( n  = 31) received nalbuphine 0.2 mg/kg i.v. over 10 min before intubation. Fiberoptic intubation was attempted and lignocaine spray and propofol boluses were administered as and when required. Hemodynamic responses and intubating conditions were recorded. Repeated measure ANOVA, McNemar test, and Chi-square test or Fischer's exact test were used for data analysis. A  P  < 0.05 was considered significant.
Results


Cough score ( P  = 0.458), post-intubation score ( P  = 1.000), and sedation score ( P  = 1.000) were comparable among the two groups. Hemodynamic responses and propofol and lignocaine requirements were also comparable.
Conclusion


Both fentanyl and nalbuphine provide comparable intubating conditions when used before awake fiberoptic intubation with minimal adverse effects on hemodynamic profile.",2021,"Cough score ( P  = 0.458), post-intubation score ( P  = 1.000), and sedation score ( P  = 1.000) were comparable among the two groups.","['awake fiberoptic bronchoscopy', '62 ASA I/II patients of either sex between the age of 20 and 60 years, weight between 40 and 80 kg, with MP class I/II airways requiring general anesthesia with endotracheal intubation']","['nalbuphine 0.2 mg/kg i.v', 'fentanyl and nalbuphine', 'standard airway topicalization and nebulization', 'Fentanyl', 'Fiberoptic intubation', 'lignocaine spray and propofol boluses', 'propofol and lignocaine', 'fentanyl 2 μg/kg i.v', 'Fentanyl versus nalbuphine']","['Hemodynamic responses', 'hemodynamic profile', 'Cough score', 'Hemodynamic responses and intubating conditions', 'post-intubation score', ""Repeated measure ANOVA, McNemar test, and Chi-square test or Fischer's exact test"", 'sedation score']","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0189391', 'cui_str': 'Fiberoptic bronchoscopy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]",62.0,0.321573,"Cough score ( P  = 0.458), post-intubation score ( P  = 1.000), and sedation score ( P  = 1.000) were comparable among the two groups.","[{'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Chaudhary', 'Affiliation': 'Department of Anesthesiology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi, India.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Chaudhary', 'Affiliation': 'Department of Anesthesiology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi, India.'}, {'ForeName': 'Mahendra', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesiology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi, India.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Salhotra', 'Affiliation': 'Department of Anesthesiology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_359_19']
2742,34759546,Effect of dexmedetomidine on characteristics of ultrasound-guided supraclavicular brachial plexus block with levobupivacaine-A prospective double-blind randomized controlled trial.,"Background and Aims


Levobupivacaine, a less cardiotoxic s-isomer of bupivacaine, is proved to be similar to bupivacaine, hence, proposed as a safer alternative for nerve blocks. We aimed to evaluate the effect of perineural and intravenous dexmedetomidine on characteristics of ultrasound-guided supraclavicular brachial plexus block (BPB) performed with levobupivacaine. The aim of this study is to evaluate the effect of perineural and intravenous dexmedetomidine on characteristics of ultrasound-guided supraclavicular BPB performed with levobupivacaine.
Material and Methods


A prospective, randomized double-blind control trial done on 120 patients undergoing elective upper limb surgical procedures under supraclavicular BPB. The enrolled patients were allocated to one of the three groups: Group L - 0.5% levobupivacaine +0.9% normal saline (NS) IV infusion; Group LDI - 0.5% levobupivacaine + dexmedetomidine (1 mcg/kg) in NS IV infusion; and Group LDP - 0.5% levobupivacaine +1 mcg/kg of dexmedetomidine perineural + NS IV infusion. The onset and duration of sensory and motor blockade were recorded in minutes. One-way ANOVA was used to observe any differences between the groups, and post hoc comparisons were conducted after Bonferroni correction for multiple comparisons.
Results


The onset of sensory and motor blockade in Group LDP was significantly shorter than Group L and Group LDI. The duration of sensory blockade in Group LDP was significantly longer than Group LDI and Group L. The duration of motor blockade in Group LDP was prolonged compared to Group LDI and Group L.
Conclusions


When dexmedetomidine is added as adjunct to levobupivacaine in supraclavicular BPB, onset of sensory and motor blockade is faster in perineural group, whereas duration of sensory and motor blockade and duration of analgesia are more prolonged when used perineurally than intravenously.",2021,The onset of sensory and motor blockade in Group LDP was significantly shorter than Group L and Group LDI.,['120 patients undergoing elective upper limb surgical procedures under supraclavicular BPB'],"['levobupivacaine', 'dexmedetomidine', 'bupivacaine', 'Group L - 0.5% levobupivacaine +0.9% normal saline (NS) IV infusion; Group LDI - 0.5% levobupivacaine + dexmedetomidine', 'Levobupivacaine', 'NS IV infusion; and Group LDP - 0.5% levobupivacaine +1 mcg/kg of dexmedetomidine perineural + NS IV infusion']","['duration of sensory and motor blockade and duration of analgesia', 'duration of sensory blockade', 'onset and duration of sensory and motor blockade', 'duration of motor blockade']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0441846', 'cui_str': 'Group L'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1627892', 'cui_str': 'ug/kg'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",120.0,0.129115,The onset of sensory and motor blockade in Group LDP was significantly shorter than Group L and Group LDI.,"[{'ForeName': 'Bhumireddy Suneel', 'Initials': 'BS', 'LastName': 'Reddy', 'Affiliation': 'Department of Anaesthesiology, Apollo Institute of Medical Sciences and Research, Chittoor, Andhra Pradesh, India.'}, {'ForeName': 'Yogesh K', 'Initials': 'YK', 'LastName': 'Gaude', 'Affiliation': 'Department of Anaesthesiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Shriram', 'Initials': 'S', 'LastName': 'Vaidya', 'Affiliation': 'Department of Anaesthesiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Gurudas K', 'Initials': 'GK', 'LastName': 'Kini', 'Affiliation': 'Department of Anaesthesiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Lokvendra S', 'Initials': 'LS', 'LastName': 'Budania', 'Affiliation': 'Department of Anaesthesiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Eeshwar', 'Affiliation': 'Department of Anaesthesiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_289_18']
2743,34759543,Optimum time of LMA ProSeal removal in adult patients undergoing isoflurane anesthesia: A randomized controlled trial.,"Background and Aims


Optimum timing of laryngeal mask airway (LMA) removal after general anesthesia with isoflurane is debatable. The objective was to investigate the potential benefits of removing LMA ProSeal at ≤0.4 Minimum alveolar concentration (MAC) isoflurane over awake and ""deep plane"" extubation after short duration laparoscopic gynecological surgery.
Material and Methods


In this prospective randomized trial 90 adult female patients undergoing elective laparoscopic surgery under general anesthesia using LMA ProSeal™ as airway device were included. At the end of surgery, LMA ProSeal™ was removed when the patient was awake, could open mouth following verbal command (Group A); at MAC ≤0.4 (Group B); or at MAC of 0.6 (Group C). Adverse airway events like nausea, vomiting, airway obstruction, coughing, bucking, laryngospasm were noted. Statistical analyses were done by SPSS statistical software (IBM SPSS Statistics for Mac OS X, Version 21.0. IBM Corp, Armonk, NY).
Results


Baseline demographic characteristics were comparable in all three groups. Coughing or bucking at the time of LMA removal was higher in group A ( P  = 0.004). Snoring and airway obstruction after LMA removal was significantly higher in group C compared to group A and group B ( P  = 0.002 and  P  = 0.011, respectively). There was significant change in mean arterial pressure and heart rate between before and after LMA removal on group A ( P  = 0.008 and  P  < 0.001, respectively) but not in other groups.
Conclusion


MAC ≤0.4 can be considered optimum depth of anesthesia for removal of LMA Proseal in adult patients undergoing isoflurane anesthesia.",2021,"Snoring and airway obstruction after LMA removal was significantly higher in group C compared to group A and group B ( P  = 0.002 and  P  = 0.011, respectively).","['adult patients undergoing isoflurane anesthesia', '90 adult female patients undergoing elective laparoscopic surgery under general anesthesia using LMA ProSeal™ as airway device were included']","['isoflurane', 'LMA ProSeal at ≤0.4 Minimum alveolar concentration (MAC) isoflurane over awake and ""deep plane"" extubation']","['Coughing or bucking at the time of LMA removal', 'mean arterial pressure and heart rate', 'Snoring and airway obstruction after LMA removal', 'Adverse airway events like nausea, vomiting, airway obstruction, coughing, bucking, laryngospasm']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0852885', 'cui_str': 'Bucking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}, {'cui': 'C1320715', 'cui_str': 'Airway event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0023066', 'cui_str': 'Laryngeal spasm'}]",90.0,0.122255,"Snoring and airway obstruction after LMA removal was significantly higher in group C compared to group A and group B ( P  = 0.002 and  P  = 0.011, respectively).","[{'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Maitra', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Dalim K', 'Initials': 'DK', 'LastName': 'Baidya', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Devalina', 'Initials': 'D', 'LastName': 'Goswami', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Thilaka', 'Initials': 'T', 'LastName': 'Muthiah', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajkumar', 'Initials': 'R', 'LastName': 'Subramanian', 'Affiliation': 'Consultant, Intensive Care Unit, Department of Intensive Care Medicine, Apollo Hospitals, Chennai, Tamil Nadu, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_238_19']
2744,34759540,A comparative evaluation of Airtraq and Hansraj Video laryngoscopes in patients undergoing tracheal intubation with cervical spine immobilization - A randomized prospective study.,"Background and Aims


Airway management is a key concern in trauma patients with cervical spine fracture. Application of manual inline axial stabilization (MIAS) has become the standard of care in these patients. Indirect laryngoscopy only requires alignment of the pharyngeal and laryngeal axis. Hence the primary objective of the study was to compare two indirect laryngoscopes, Airtraq (with adaptor) and Hansraj Video laryngoscopes based on its Intubation Difficulty Score.
Material and Methods


Sixty anesthetized patients were divided into two groups using computer-based randomization, and tracheal intubation was performed using either Airtraq or Hansraj Videolaryngoscope with cervical spine immobilization.
Results


Both Airtraq and Hansraj groups were comparable in terms of percentage of glottic opening (POGO) scoring (92 ± 9.88% vs. 89.3 ± 10.4%.) and duration of intubation attempt (14.9 ± 4.36 sec vs. 16.97 ± 3.64 sec). Intubation difficulty scale (IDS) score was significantly shorter with Airtraq (1 ± 0.58 vs. 1.8 ± 0.805;  P  < 0.0001). The mean duration of time taken for laryngoscopy in Airtraq (12.9 ± 2.07 s vs. 19.06 ± 3.83 s;  P  < 0.0001)) was significantly shorter and also the duration of time taken to secure airway in Airtraq VL was significantly shorter (29.47 ± 4.75 s vs. 36.03 ± 5.80 sec;  P  < 0.0001). The heart rate and MABP changes were modest in both groups, but was significantly more in Hansraj VL as compared to Airtraq VL, post-intubation.
Conclusion


Both Airtraq and Hansraj videolaryngoscope can be used as first-hand device in the scenario of cervical spine stabilization. Airtraq videolaryngoscope is better than Hansraj videolaryngoscope due to shorter IDS and lessor hemodynamic changes.",2021,Intubation difficulty scale (IDS) score was significantly shorter with Airtraq (1 ± 0.58 vs. 1.8 ± 0.805;  P  < 0.0001).,"['Material and Methods\n\n\nSixty anesthetized patients', 'patients undergoing tracheal intubation with cervical spine immobilization ', 'trauma patients with cervical spine fracture']","['Indirect laryngoscopy', 'computer-based randomization, and tracheal intubation was performed using either Airtraq or Hansraj Videolaryngoscope with cervical spine immobilization', 'manual inline axial stabilization (MIAS', 'Airtraq and Hansraj Video laryngoscopes']","['Intubation difficulty scale (IDS) score', 'heart rate and MABP changes', 'duration of time taken to secure airway in Airtraq VL', 'duration of intubation attempt', 'mean duration of time taken for laryngoscopy', 'percentage of glottic opening (POGO) scoring']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1301792', 'cui_str': 'Cervical spine immobilization'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0262414', 'cui_str': 'Fracture of cervical spine'}]","[{'cui': 'C0189266', 'cui_str': 'Indirect laryngoscopy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C1301792', 'cui_str': 'Cervical spine immobilization'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",60.0,0.0107258,Intubation difficulty scale (IDS) score was significantly shorter with Airtraq (1 ± 0.58 vs. 1.8 ± 0.805;  P  < 0.0001).,"[{'ForeName': 'Poojangi', 'Initials': 'P', 'LastName': 'Varshney', 'Affiliation': 'Dr Poojangi Varshney: Senior Resident, GTB, New Delhi Syed M. Ahmed: Professor in the Department of Anesthesiology JNMCH, AMU. Abu Nadeem: Associate Prof in the Department of Anesthesiology JNMCH, AMU. Obaid A. Siddiqui: Associate Prof in the Department of Anesthesiology JNMCH, AMU Ajmal PM: Assistant Professor GMC, Palakkad, Kerala.'}, {'ForeName': 'Syed M', 'Initials': 'SM', 'LastName': 'Ahmed', 'Affiliation': 'Dr Poojangi Varshney: Senior Resident, GTB, New Delhi Syed M. Ahmed: Professor in the Department of Anesthesiology JNMCH, AMU. Abu Nadeem: Associate Prof in the Department of Anesthesiology JNMCH, AMU. Obaid A. Siddiqui: Associate Prof in the Department of Anesthesiology JNMCH, AMU Ajmal PM: Assistant Professor GMC, Palakkad, Kerala.'}, {'ForeName': 'Obaid A', 'Initials': 'OA', 'LastName': 'Siddiqui', 'Affiliation': 'Dr Poojangi Varshney: Senior Resident, GTB, New Delhi Syed M. Ahmed: Professor in the Department of Anesthesiology JNMCH, AMU. Abu Nadeem: Associate Prof in the Department of Anesthesiology JNMCH, AMU. Obaid A. Siddiqui: Associate Prof in the Department of Anesthesiology JNMCH, AMU Ajmal PM: Assistant Professor GMC, Palakkad, Kerala.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Nadeem', 'Affiliation': 'Dr Poojangi Varshney: Senior Resident, GTB, New Delhi Syed M. Ahmed: Professor in the Department of Anesthesiology JNMCH, AMU. Abu Nadeem: Associate Prof in the Department of Anesthesiology JNMCH, AMU. Obaid A. Siddiqui: Associate Prof in the Department of Anesthesiology JNMCH, AMU Ajmal PM: Assistant Professor GMC, Palakkad, Kerala.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Ajmal', 'Affiliation': 'Dr Poojangi Varshney: Senior Resident, GTB, New Delhi Syed M. Ahmed: Professor in the Department of Anesthesiology JNMCH, AMU. Abu Nadeem: Associate Prof in the Department of Anesthesiology JNMCH, AMU. Obaid A. Siddiqui: Associate Prof in the Department of Anesthesiology JNMCH, AMU Ajmal PM: Assistant Professor GMC, Palakkad, Kerala.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_327_19']
2745,34759395,Comparative Effectiveness and Safety of Methotrexate Versus PUVA in Severe Chronic Stable Plaque Psoriasis.,"Background


Psoriasis is a chronic, inflammatory, immune-mediated, debilitating skin disease affecting approximately 2%-3% of the global population. Various treatment modalities are available for extensive psoriasis which include methotrexate, cyclosporine, retinoids, oral PUVA therapy, and biologic agents.
Aims and Objectives


The aim of this study was to compare the effectiveness and safety of methotrexate vs. PUVA in severe chronic plaque psoriasis with BSA >20%.
Materials and Methods


A randomized open-label clinical study was performed. Sixty patients with extensive stable plaque psoriasis were recruited in the study. Thirty patients received methotrexate at a dose of 0.4 mg/kg up to a maximum of 15 mg/week and the rest 30 were treated by PUVA, 8-methoxy psoralen tablet (20 mg) followed by UVA started at the dose of 1 j/cm 2  thrice weekly with an increment of 20% dose every third sitting until 2.5 j/cm 2  is reached. Both forms of treatment were continued for 10 weeks or until PASI 90 achieved, which-ever was earlier. Clinical examination, blood investigation, PASI scoring, and photograph were repeated in serial intervals during the study. At the end of study, the data were compiled, tabulated, and analyzed.
Result


In the PUVA group, 90% achieved PASI-50 and 63.33% achieved PASI-90, in the methotrexate group all patients achieved both PASI-50 and PASI-90. Methotrexate acted significantly faster than PUVA in disease clearance. In the methotrexate group decreased platelet count in 13.33% patients, decreased hemoglobin (<10 gm/dl), elevated liver enzyme, each of these developed in 10% of patients. In the PUVA group, no serious side effects were observed.
Conclusions


Methotrexate is more efficacious with lesser incidence of subjective complications and more incidence of laboratory complications compared to PUVA in extensive plaque psoriasis.",2021,"In the methotrexate group decreased platelet count in 13.33% patients, decreased hemoglobin (<10 gm/dl), elevated liver enzyme, each of these developed in 10% of patients.","['severe chronic plaque psoriasis with BSA >20', 'Severe Chronic Stable Plaque Psoriasis', 'Sixty patients with extensive stable plaque psoriasis']","['PUVA', 'methotrexate vs. PUVA', 'methotrexate, cyclosporine, retinoids, oral PUVA therapy', 'PUVA, 8-methoxy psoralen tablet', 'methotrexate', 'Methotrexate Versus PUVA', 'Methotrexate']","['effectiveness and safety', 'disease clearance', 'platelet count', 'Clinical examination, blood investigation, PASI scoring, and photograph', 'elevated liver enzyme', 'serious side effects', 'hemoglobin']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C1304119', 'cui_str': 'Chronic stable plaque psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0853073', 'cui_str': 'PUVA'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0035339', 'cui_str': 'Retinoid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034172', 'cui_str': 'Photochemotherapy with psoralens and ultraviolet A'}, {'cui': 'C0016072', 'cui_str': 'Ficusin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0702196', 'cui_str': 'Blood investigation'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",60.0,0.00847823,"In the methotrexate group decreased platelet count in 13.33% patients, decreased hemoglobin (<10 gm/dl), elevated liver enzyme, each of these developed in 10% of patients.","[{'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, NRS Medical College, Kolkata, India.'}, {'ForeName': 'Suchibrata', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, NRS Medical College, Kolkata, India.'}, {'ForeName': 'Alok K', 'Initials': 'AK', 'LastName': 'Roy', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, NRS Medical College, Kolkata, India.'}, {'ForeName': 'Loknath', 'Initials': 'L', 'LastName': 'Ghoshal', 'Affiliation': 'Associate Professor and Head of the Department, Department of Dermatology, Malda Medical College and Hospital, Malda, West Bengal, India.'}]",Indian journal of dermatology,['10.4103/ijd.IJD_492_20']
2746,34759773,"Professional Mental Rehearsal: the Power of ""Imagination"" in Nursing Skills Training.","Background


Mental rehearsal is a form of training used by nurse educators to enhance the performance of clinical skills. The use of imagination may facilitate cognitive and affective modification and subsequently may even reduce extraneous cognitive load.
Objective


The aim of the study was to investigate the efficacy of mental rehearsal in cardiopulmonary resuscitation training of nursing students.
Methods


This is a comparative study with a random sample of 52 Nurse-Assistant students who were randomly divided into two groups. A 10-minute educational video on CPR and defibrillation was shown to both groups with the experimental group having additional time to be coached on mental rehearsal. Student performance was subsequently timed and errors/overall performance recorded. Descriptive statistics and Mann-Whitney test was used for group comparisons analysis.
Results


Students in the control group needed 8.5 minutes on average as compared to 6.2 minutes for the experimental group to complete cardiopulmonary resuscitation training. This equals to a difference of 2.5 minutes faster time for the experimental group (p<0.001). For overall mistakes the mental rehearsal group had 1.3 fewer mistakes on average (p=0.003). In terms of mistakes when executing cardiopulmonary resuscitation training there were 0.9 fewer mistakes in the experimental group (p=0.021).
Conclusion


The use of mental rehearsal might be the first step in improving the teaching of nursing skills. Differences in skill acquisition in favor of mental rehearsal are important, especially when this technique is used in the teaching of life-saving skills such as cardiopulmonary resuscitation and the use of defibrillate.",2021,For overall mistakes the mental rehearsal group had 1.3 fewer mistakes on average (p=0.003).,"['nursing students', '52 Nurse-Assistant students']","['mental rehearsal', 'Professional Mental Rehearsal']",[],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],[],,0.00687126,For overall mistakes the mental rehearsal group had 1.3 fewer mistakes on average (p=0.003).,"[{'ForeName': 'Antigoni', 'Initials': 'A', 'LastName': 'Fountouki', 'Affiliation': 'Nursing Department, International Hellenic University, Greece.'}, {'ForeName': 'Stiliani', 'Initials': 'S', 'LastName': 'Kotrotsiou', 'Affiliation': 'Health Care Lab, University of Thessaly, Greece.'}, {'ForeName': 'Theodosios', 'Initials': 'T', 'LastName': 'Paralikas', 'Affiliation': 'Health Care Lab, University of Thessaly, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Malliarou', 'Affiliation': 'Nursing Department, University of Thessaly, Greece.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Konstanti', 'Affiliation': 'Laboratory Teaching Staff, Nursing Department, University of Ioannina, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsioumanis', 'Affiliation': 'Mobile Health Units, National Public Health Organization (NPHO), Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Theofanidis', 'Affiliation': 'Nursing Department, International Hellenic University, Greece.'}]",Materia socio-medica,['10.5455/msm.2021.33.174-178']
2747,34759711,Erratum: The Effect of Mindfulness on Quality of Life among Women with Premature Ovarian Insufficiency: A Randomized Clinical Trial.,"[This corrects the article on p. 116 in vol. 12, PMID: 34526745.].",2021,"[This corrects the article on p. 116 in vol. 12, PMID: 34526745.].",['Women with Premature Ovarian Insufficiency'],['Mindfulness'],['Quality of Life'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.268292,"[This corrects the article on p. 116 in vol. 12, PMID: 34526745.].",[],Journal of mid-life health,['10.4103/0976-7800.328372']
2748,34759703,Role of Short-Term Estradiol Supplementation in Symptomatic Postmenopausal COVID-19 Females: A Randomized Controlled Trial.,"Background


Protective role of estrogen in COVID-19 was speculated once the epidemiological studies reported increased susceptibility of estrogen-deficient population - males and postmenopausal females to severe disease category and involvement of angiotensin-converting enzyme 2 receptors and renin-angiotensin- aldosterone system in pathophysiology.
Materials & Methods


An open-label randomized controlled trial was planned to assess the efficacy of short-course oral estradiol in preventing the clinical progression to severe disease and reduce case-fatality rate and the hospital stay duration in estrogen-deficient postmenopausal women. The intervention group ( n  = 40) received 2 mg per day of estradiol valerate per orally for 7 days along with the standard care, while the control group ( n  = 40) received only the standard care.
Results


A significant difference was observed in the rate of reverse transcriptase-polymerase chain reaction negativization in the intervention versus control group at day 5 and day 7 of admission (42.5% vs. 15%,  P  = 0.007; 72.5% versus 50%,  P  = -0.026). No significant difference was noted in the duration of hospitalization ( P  = 0.213). A significant decrease was noted in the mean values of inflammatory biomarkers - D-dimer, lactate dehydrogenase, and C-reactive protein on day 5 in the intervention group. Interleukin-6 also showed a declining trend on day 5 in the intervention group, while a rising trend was noted in the control arm. Only one case (2.5%) in the intervention group while seven in the control group (17.5%) progressed to the moderate category; however, the difference was not statistically significant ( P  = 0.057).
Conclusion


Oral estradiol in postmenopausal females can be a novel and efficient option for managing nonsevere COVID-19 infection.",2021,"A significant difference was observed in the rate of reverse transcriptase-polymerase chain reaction negativization in the intervention versus control group at day 5 and day 7 of admission (42.5% vs. 15%,  P  = 0.007; 72.5% versus 50%,  P  = -0.026).","['estrogen-deficient postmenopausal women', 'Symptomatic Postmenopausal COVID-19 Females', 'postmenopausal females']","['Short-Term Estradiol Supplementation', 'estradiol valerate', 'Oral estradiol', 'short-course oral estradiol']","['mean values of inflammatory biomarkers - D-dimer, lactate dehydrogenase, and C-reactive protein', 'rate of reverse transcriptase-polymerase chain reaction negativization', 'duration of hospitalization', 'Interleukin-6']","[{'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0059623', 'cui_str': 'Estradiol valerate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.109532,"A significant difference was observed in the rate of reverse transcriptase-polymerase chain reaction negativization in the intervention versus control group at day 5 and day 7 of admission (42.5% vs. 15%,  P  = 0.007; 72.5% versus 50%,  P  = -0.026).","[{'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Seth', 'Affiliation': 'Department of Obstetrics and Gynaecology, GIMS, Greater Noida, Uttar Pradesh, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, GIMS, Greater Noida, Uttar Pradesh, India.'}, {'ForeName': 'Pinky', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Department of Obstetrics and Gynaecology, GIMS, Greater Noida, Uttar Pradesh, India.'}, {'ForeName': 'Hariom Kumar', 'Initials': 'HK', 'LastName': 'Solanki', 'Affiliation': 'Department of Community Medicine, GIMS, Greater Noida, Uttar Pradesh, India.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Obstetrics and Gynaecology, GIMS, Greater Noida, Uttar Pradesh, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Biochemistry, GIMS, Greater Noida, Uttar Pradesh, India.'}]",Journal of mid-life health,['10.4103/jmh.JMH_57_21']
2749,34759689,A Comparison of NovaMin ™  and Casein Phosphopeptide-Amorphous Calcium Phosphate Fluoride on Enamel Remineralization - An  In vitro  Study Using Scanning Electron Microscope and DIAGNOdent ® .,"Aim


The aim of this study was to compare the efficacy of NovaMin ™  (SHY-NM) and casein phosphopeptide-amorphous calcium phosphate fluoride (CPP-ACPF) (tooth mousse plus ™ ) on enamel remineralization using DIAGNOdent ®  and scanning electron microscope (SEM).
Methodology


Eighty-six natural permanent maxillary first premolars were selected and randomly divided into two groups of 43 each, Group A (NovaMin ™ ) and Group B (CPP-ACPF). All the samples were assessed using DIAGNOdent ®  (KaVo) at the baseline, after demineralization, and remineralization after 7 days. Two samples were randomly selected from each group after remineralization to evaluate the surface changes using SEM at × 1000 and × 2000.
Results


The mean value of remineralization was highest for Group A NovaMin ™  (6.56 ± 0.93) compared to Group B, CPP-ACPF (tooth mousse plus ™ ) (6.02 ± 1.09). The maximum demineralization to remineralization value within the groups showed that the mean values in Group B CPP-ACPF (7.02 ± 3.02) was higher than Group A NovaMin ™  (6.42 ± 2.21). The difference in remineralizing potential between the groups and demineralization to remineralization value in within-group comparison was not found to be statistically significant.
Conclusion


On comparing Group A NovaMin ™  and Group B CPP-ACPF, Group B CPP-ACPF showed a higher amount of remineralization than Group A NovaMin ™ . From the present study, it can be inferred that both the experimental groups have the potential for remineralization.",2021,"The mean value of remineralization was highest for Group A NovaMin ™  (6.56 ± 0.93) compared to Group B, CPP-ACPF (tooth mousse plus ™ ) (6.02 ± 1.09).",['Methodology\n\n\nEighty-six natural permanent maxillary first premolars'],"['NovaMin ™  (SHY-NM) and casein phosphopeptide-amorphous calcium phosphate fluoride (CPP-ACPF', 'Group A (NovaMin ™ ) and Group B (CPP-ACPF', 'Scanning Electron Microscope and DIAGNOdent ® ', 'NovaMin ™  and Casein Phosphopeptide-Amorphous Calcium Phosphate Fluoride']","['remineralizing potential', 'Enamel Remineralization ', 'maximum demineralization to remineralization value', 'mean value of remineralization']","[{'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C1722474', 'cui_str': 'NovaMin'}, {'cui': 'C0557869', 'cui_str': 'Introvert'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181845', 'cui_str': 'Electron microscope'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0700185', 'cui_str': 'Decalcified structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.023986,"The mean value of remineralization was highest for Group A NovaMin ™  (6.56 ± 0.93) compared to Group B, CPP-ACPF (tooth mousse plus ™ ) (6.02 ± 1.09).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dhanya', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Chandra', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Anandakrishna', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Vineetha', 'Initials': 'V', 'LastName': 'Karuveettil', 'Affiliation': 'Department of Public Health Dentistry, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_240_19']
2750,34759690,Comparative Evaluation of Effectiveness of 2% Lignocaine Hydrochloride with Clonidine Hydrochloride versus 2% Lignocaine Hydrochloride with Adrenaline Bitartrate as Local Anesthetic for Adult Patients Undergoing Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Controlled Clinical Study.,"Background and Objectives


Clonidine is a common additive to local anesthetics for various regional and local nerve blocks. However, its effectiveness in dentistry has not yet been fully explored. Thus, this study was performed to evaluate the quality of anesthesia, vasoconstrictive effects, hemodynamic response, and pain control using a solution of 2% lignocaine hydrochloride with clonidine hydrochloride in comparison with the standard solution of 2% lignocaine hydrochloride and adrenaline bitartrate for pterygomandibular nerve blocks.
Materials and Methods


A parallel arm, triple-blind randomized controlled study was conducted on 152 patients belonging to ASA-I (American Society of Anesthesiologists) category in the age group of 18-45 years, requiring surgical extraction of impacted mandibular third molars. The patients were divided equally into two groups randomly by computer-generated sequence; Group 1: 2% lignocaine hydrochloride with 1 ml of clonidine hydrochloride (150 μg/ml) and Group 2: 2% lignocaine hydrochloride with adrenaline bitartrate 1: 80,000 (12.5 μg/ml). The variables evaluated were systolic, diastolic, and mean arterial blood pressures, heart rate (HR), blood loss, onset, depth (pain), and duration of anesthesia.
Results


There was a statistically nonsignificant difference seen between the two groups ( P  > 0.05) for the onset of anesthesia, pain assessed, and blood loss, whereas a statistically highly significant difference was seen for cardiovascular variables (systolic, diastolic and mean arterial blood pressures, and HR) at various intervals with higher values for Group 2 ( P  < 0.001) and for the duration of action of local anesthesia (LA), with higher values for Group 1 ( P  < 0.001).
Conclusions


Clonidine as an additive to lignocaine has proved to have the onset of action, vasoconstrictive properties, and pain control, equivalent to adrenaline. However, with better stability of hemodynamic variables and prolonged duration of action of LA with clonidine, it can be considered as a better, safer, and more effective additive to lignocaine than adrenaline.",2021,"There was a statistically nonsignificant difference seen between the two groups ( P  > 0.05) for the onset of anesthesia, pain assessed, and blood loss, whereas a statistically highly significant difference was seen for cardiovascular variables (systolic, diastolic and mean arterial blood pressures, and HR) at various intervals with higher values for Group 2 ( P  < 0.001) and for the duration of action of local anesthesia (LA), with higher values for Group 1 ( P  < 0.001).
","['Adult Patients', 'Undergoing Surgical Extraction of Impacted Mandibular Third Molars', '152 patients belonging to ASA-I (American Society of Anesthesiologists) category in the age group of 18-45 years, requiring surgical extraction of impacted mandibular third molars']","['Clonidine', 'Lignocaine Hydrochloride with Adrenaline Bitartrate', 'lignocaine hydrochloride with clonidine hydrochloride', 'Lignocaine Hydrochloride with Clonidine Hydrochloride', 'clonidine', 'lignocaine hydrochloride and adrenaline bitartrate', 'lignocaine hydrochloride with 1 ml of clonidine hydrochloride', 'lignocaine hydrochloride with adrenaline bitartrate', 'lignocaine']","['quality of anesthesia, vasoconstrictive effects, hemodynamic response, and pain control', 'duration of action of local anesthesia (LA', 'onset of anesthesia, pain assessed, and blood loss', 'cardiovascular variables (systolic, diastolic and mean arterial blood pressures, and HR', 'systolic, diastolic, and mean arterial blood pressures, heart rate (HR), blood loss, onset, depth (pain), and duration of anesthesia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1293139', 'cui_str': 'Surgical extraction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine hydrochloride'}, {'cui': 'C0700536', 'cui_str': 'Epinephrine bitartrate'}, {'cui': 'C0546860', 'cui_str': 'Clonidine hydrochloride'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",152.0,0.0222146,"There was a statistically nonsignificant difference seen between the two groups ( P  > 0.05) for the onset of anesthesia, pain assessed, and blood loss, whereas a statistically highly significant difference was seen for cardiovascular variables (systolic, diastolic and mean arterial blood pressures, and HR) at various intervals with higher values for Group 2 ( P  < 0.001) and for the duration of action of local anesthesia (LA), with higher values for Group 1 ( P  < 0.001).
","[{'ForeName': 'Shreyas H', 'Initials': 'SH', 'LastName': 'Gupte', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, YMT Dental College and Hospital, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Rinku D', 'Initials': 'RD', 'LastName': 'Kalra', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, YMT Dental College and Hospital, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Thomson M', 'Initials': 'TM', 'LastName': 'Dcruz', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, YMT Dental College and Hospital, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Kamble', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, YMT Dental College and Hospital, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Ranjana S', 'Initials': 'RS', 'LastName': 'Patnaik', 'Affiliation': 'Department of Clinical Research, School of Biosciences and Biomedical Engineering, Galgotias University, Greater Noida, Uttar Pradesh, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_665_20']
2751,34759686,Efficacy of Preprocedural Boric Acid Mouthrinse in Reducing Viable Bacteria in Dental Aerosols Produced during Ultrasonic Scaling.,"Introduction


Aerosols and droplets contaminated with bacteria and blood are produced during ultrasonic scaling. Measures to control aerosol contamination in dental clinics are recommended by the Centers for Disease Control and Prevention. This study aimed to evaluate the efficacy of preprocedural boric acid (BA) mouthrinse in reducing bacterial contamination in dental aerosols generated during ultrasonic scaling.
Materials and Methods


This was a randomised clinical trial in 90 systemically healthy subjects (25-55 yrs) diagnosed with chronic periodontitis who were allocated into three groups of 30 subjects each to receive, Group A - 0.12% chlorhexidine (CHX), Group B - 0.75% BA and Group C-water, as a preprocedural rinse for 1 min. The aerosol generated while performing ultrasonic scaling for 30 min was collected at three locations on blood agar plates. Incubation of the blood agar plates at 37°C for next 48 h for aerobic culture was performed and subsequently colony-forming units (CFUs) were counted.
Results


CFUs in Group A were significantly reduced compared with Group B ( P  < 0.001). When we compare CFUs in all the three groups, CFUs in Groups A and B were statistically significantly reduced compared with Group C ( P  < 0.001). Furthermore, it was also observed that the assistant's chest area had lowest CFUs whereas patient's chest area had highest.
Conclusion


This study recommends routine use of preprocedural mouthrinse as a measure to reduce bacterial aerosols generated during ultrasonic scaling and that 0.12% CHX gluconate is more effective than 0.75% BA mouthwash in reducing CFUs count.",2021,"When we compare CFUs in all the three groups, CFUs in Groups A and B were statistically significantly reduced compared with Group C ( P  < 0.001).","['Dental Aerosols Produced during Ultrasonic Scaling', '90 systemically healthy subjects (25-55 yrs) diagnosed with chronic periodontitis']","['preprocedural boric acid (BA) mouthrinse', 'Preprocedural Boric Acid Mouthrinse', 'CHX gluconate', 'chlorhexidine (CHX']",['CFUs count'],"[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}]","[{'cui': 'C0006020', 'cui_str': 'boric acid'}, {'cui': 'C0017714', 'cui_str': 'Gluconates'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C0439157', 'cui_str': 'counts'}]",90.0,0.0296515,"When we compare CFUs in all the three groups, CFUs in Groups A and B were statistically significantly reduced compared with Group C ( P  < 0.001).","[{'ForeName': 'Swet', 'Initials': 'S', 'LastName': 'Nisha', 'Affiliation': 'Department of Periodontology, J.S.S Dental College and Hospital, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.'}, {'ForeName': 'Avinash Bettahalli', 'Initials': 'AB', 'LastName': 'Shivamallu', 'Affiliation': 'Department of Periodontology, J.S.S Dental College and Hospital, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.'}, {'ForeName': 'Sheela Kumar', 'Initials': 'SK', 'LastName': 'Gujjari', 'Affiliation': 'Department of Periodontology, J.S.S Dental College and Hospital, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Shashikumar', 'Affiliation': 'Department of Periodontology, J.S.S Dental College and Hospital, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.'}, {'ForeName': 'Nada Musharraf', 'Initials': 'NM', 'LastName': 'Ali', 'Affiliation': 'Department of Periodontology, J.S.S Dental College and Hospital, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.'}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Kulkarni', 'Affiliation': 'Department Of Microbiology, J.S.S Medical College and Hospital, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_374_20']
2752,34759678,"Microscopic Assessment of Dentinal Defects Induced by ProTaper Universal, ProTaper Gold, and Hyflex Electric Discharge Machining Rotary File Systems - An  in vitro  Study.","Background


Biomechanical preparation of root canal can damage root dentin leading to the formation of dentinal cracks which can eventually lead to fracture and failure of the treatment.
Aim


The aim was to investigate the incidence of dentinal defects in root canals prepared with ProTaper Universal, ProTaper Gold, and Hyflex electric discharge machining (EDM) rotary file systems using handheld USB digital microscope.
Materials and Methods


One hundred and fifty extracted mandibular premolar teeth with single canal were randomly divided into five groups ( n  = 30). Group 1: unprepared (negative control). Group 2: canal preparation done with nickel-titanium hand files (positive control), Group 3: canals prepared with ProTaper Universal rotary system, Group 4: canal preparation done with ProTaper Gold rotary system, and Group 5: canals prepared with Hyflex EDM rotary system. The specimens were sliced at 3 mm, 6 mm, and 9 mm from the apex with a slow-speed saw under water cooling. Digital images of each section were captured at ×40 magnification with the aid of a microscope. Two independent evaluators assessed the images for the presence of dentinal defects. The number of dentinal defects was recorded and Chi-square test was used for statistical analysis ( P  < 0.05).
Results


The number of specimens presenting dentinal defects was as follows: Group 3; ProTaper Universal - 9/30 (30.0%), Group 4; ProTaper Gold - 2/30 (6.7%), and Group 5; Hyflex EDM - 1/30 (3.3%). No defects were detected in the negative and positive control groups (Group 1 and Group 2).
Conclusion


ProTaper Universal showed the highest percentage of defects in comparison to ProTaper Gold and Hyflex EDM.",2021,"No defects were detected in the negative and positive control groups (Group 1 and Group 2).
",['One hundred and fifty extracted mandibular premolar teeth with single canal'],"['canal preparation done with nickel-titanium hand files (positive control), Group 3: canals prepared with ProTaper Universal rotary system, Group 4: canal preparation done with ProTaper Gold rotary system, and Group 5: canals prepared with Hyflex EDM rotary system', 'ProTaper Universal, ProTaper Gold, and Hyflex electric discharge machining (EDM) rotary file systems']","['number of dentinal defects', 'number of specimens presenting dentinal defects']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}]","[{'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0563526', 'cui_str': 'Electric discharge'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",150.0,0.0463195,"No defects were detected in the negative and positive control groups (Group 1 and Group 2).
","[{'ForeName': 'Takhellambam Premlata', 'Initials': 'TP', 'LastName': 'Devi', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Dental College, Regional Institute of Medical Sciences, Imphal, Manipur, India.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Kaur', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Dental College, Regional Institute of Medical Sciences, Imphal, Manipur, India.'}, {'ForeName': 'Shamurailatpam', 'Initials': 'S', 'LastName': 'Priyadarshini', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Dental College, Regional Institute of Medical Sciences, Imphal, Manipur, India.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Deepak', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Dental College, Regional Institute of Medical Sciences, Imphal, Manipur, India.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Department of Oral Pathology and Microbiology, Dental College, Regional Institute of Medical Sciences, Imphal, Manipur, India.'}, {'ForeName': 'Ng', 'Initials': 'N', 'LastName': 'Sanjeeta', 'Affiliation': 'Department of Oral Pathology and Microbiology, Dental College, Regional Institute of Medical Sciences, Imphal, Manipur, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_631_20']
2753,34759679,"Influence of Adjunctive Photodynamic Therapy on Interleukin-6, Interleukin-8, and Interleukin-10 Gingival Crevicular Fluid Levels in Chronic Periodontitis - A Randomized Controlled Trial.","Background


Numerous studies have assessed the effect of photodynamic therapy (PDT) both as a primary mode of treatment and as an adjunct to scaling and root planing in the treatment of periodontitis. Some results were nondefinitive and, in part, inconsistent with respect to the clinical and biochemical effects. Hence, the aim of this study was to evaluate the effect of PDT as an adjunct to nonsurgical periodontal therapy (NSPT) on the gingival crevicular fluid (GCF) interleukin-6 (IL-6), IL-8, and IL-10 levels in the treatment of chronic periodontitis (CP).
Materials and Methods


In 21 patients with CP, two contralateral sites (premolar and molar) were randomly divided into: control sites (treated with NSPT only) and test sites (treated with NSPT + PDT). Clinical parameters including bleeding on probing (BOP), probing pocket depth, clinical attachment level were evaluated at baseline, 1- and 3 months and biochemical parameters of GCF levels of IL-6, IL-8, and IL-10 were evaluated at baseline and 3-month post-therapy through enzyme-linked immunosorbant assay.
Results


A greater improvement in BOP score at 1 month (41.10% ± 3.58%) and 3-months (38.00% ± 3.62%) posttherapy was found in the test site as compared to control site. Regarding cytokines, test sites exhibited significant reductions in IL-6 (4.29 ± 0.67 pg/ml) and IL-8 (308.16 ± 36.04 pg/ml) levels and increase in IL-10 (14.25 ± 0.83 pg/ml) level at 3 months ( P  < 0.0001).
Conclusion


Additional application of PDT, adjunctive to NSPT, resulted in a significant reduction in BOP score as well as GCF pro-inflammatory cytokine levels along with an increase in anti-inflammatory cytokine levels, compared to NSPT alone.",2021,"Regarding cytokines, test sites exhibited significant reductions in IL-6 (4.29 ± 0.67 pg/ml) and IL-8 (308.16 ± 36.04 pg/ml) levels and increase in IL-10 (14.25 ± 0.83 pg/ml) level at 3 months ( P  < 0.0001).
","['chronic periodontitis (CP', '21 patients with CP, two contralateral sites (premolar and molar']","['Adjunctive Photodynamic Therapy', 'PDT', 'photodynamic therapy (PDT', 'control sites (treated with NSPT only) and test sites (treated with NSPT + PDT', 'nonsurgical periodontal therapy (NSPT']","['IL-8', 'IL-6', 'GCF pro-inflammatory cytokine levels', 'Interleukin-6, Interleukin-8, and Interleukin-10 Gingival Crevicular Fluid Levels', 'GCF levels of IL-6, IL-8, and IL-10', 'gingival crevicular fluid (GCF) interleukin-6 (IL-6), IL-8, and IL-10 levels', 'bleeding on probing (BOP), probing pocket depth, clinical attachment level', 'BOP score', 'IL-10']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",21.0,0.294035,"Regarding cytokines, test sites exhibited significant reductions in IL-6 (4.29 ± 0.67 pg/ml) and IL-8 (308.16 ± 36.04 pg/ml) levels and increase in IL-10 (14.25 ± 0.83 pg/ml) level at 3 months ( P  < 0.0001).
","[{'ForeName': 'Vishakha Vilas', 'Initials': 'VV', 'LastName': 'Kharkar', 'Affiliation': 'Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Nagpur, Maharashtra, India.'}, {'ForeName': 'Abhay Pandurang', 'Initials': 'AP', 'LastName': 'Kolte', 'Affiliation': 'Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Nagpur, Maharashtra, India.'}, {'ForeName': 'Rajashri Abhay', 'Initials': 'RA', 'LastName': 'Kolte', 'Affiliation': 'Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Nagpur, Maharashtra, India.'}, {'ForeName': 'Pranjali Vijaykumar', 'Initials': 'PV', 'LastName': 'Bawankar', 'Affiliation': 'Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Nagpur, Maharashtra, India.'}, {'ForeName': 'Vrushali Nilesh', 'Initials': 'VN', 'LastName': 'Lathiya', 'Affiliation': 'Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Nagpur, Maharashtra, India.'}, {'ForeName': 'Girish Haripal', 'Initials': 'GH', 'LastName': 'Bodhare', 'Affiliation': 'Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Nagpur, Maharashtra, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_510_20']
2754,34759677,Comparative Evaluation of Efficacy of Different Irrigating Needles and Devices in Removal of Debris from Apical Third of Root Canal: An  In-vitro  SEM Study.,"Background


Irrigants were required to eliminate the microbes and debris from the intraradicular space and must have direct contact with the entire root canal wall. Therefore, different irrigation methods have been proposed to deliver the irrigant as close as possible to the remote areas of the root canal.
Aim


The aim of the present study is to evaluate the cleaning efficacy of single-beveled needle, side-vented needle, endovac, and endo-irrigator plus in the removal of debris from apical third of root canal by Scanning Electron Microscope.
Materials and Methods


Forty single-rooted freshly extracted human permanent mandibular premolars were collected. Root canals were cleaned and instrumented till X2 (25/06) with rotary Protaper Next at working length 1 mm short of the apex. Teeth were randomly divided into four equal groups: Group 1 ( n  = 10): Endovac, Group 2 ( n  = 10): Endo irrigator plus, Group 3 ( n  = 10): Side-vented needle, and Group 4 ( n  = 10): Single-beveled needle. Irrigation was done with 5.25% NaOCl, followed by 17% ethylenediaminetetraacetic acid. Samples were sectioned and examined under SEM at apical levels.
Statistical Analysis


Analysis of variance followed by Tukey's  post hoc  test was performed.
Results


The level of debris removal efficacy is as follows: Endovac > Endo-irrigator plus > Side-vented needle ~ Single-beveled needle.
Conclusion


Endovac showed the maximum number of debris removal and has better cleaning efficacy in the apical areas of the root canal, followed by Endo irrigator plus, Side-vented needle and Single-beveled needle.",2021,"Conclusion


Endovac showed the maximum number of debris removal and has better cleaning efficacy in the apical areas of the root canal, followed by Endo irrigator plus, Side-vented needle and Single-beveled needle.",['Materials and Methods\n\n\nForty single-rooted freshly extracted human permanent mandibular premolars'],"['Endovac > Endo-irrigator plus > Side-vented needle ~ Single-beveled needle', 'ethylenediaminetetraacetic acid', 'Endo irrigator plus, Group 3 ( n  = 10): Side-vented needle, and Group 4 ( n  = 10): Single-beveled needle', 'single-beveled needle, side-vented needle, endovac, and endo-irrigator plus', 'Different Irrigating Needles and Devices']",['level of debris removal efficacy'],"[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0335463', 'cui_str': 'Irrigator'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0181988', 'cui_str': 'Medication transfer needle, vented'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1720515', 'cui_str': 'Bevel needle'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",40.0,0.110608,"Conclusion


Endovac showed the maximum number of debris removal and has better cleaning efficacy in the apical areas of the root canal, followed by Endo irrigator plus, Side-vented needle and Single-beveled needle.","[{'ForeName': 'Isha', 'Initials': 'I', 'LastName': 'Srivastava', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, All India Institute of Medical Sciences, Gorakhpur, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Grover', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Paliwal', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_468_20']
2755,34759647,Use of conventional DJ stent and single loop stent with string after ureterorenoscopic lithotripsy: Can we use? Can it be effective?,"Context


Use of conventional double j stent with string and single loop stent with string after ureterorenoscopy.
Aim


The aim of this study was to compare the use of both types of stents using the Ureteral Symptom Score Questionnaire (USSQ) and assess proximal migration.
Settings and Design


This was a single institute study.
Subjects and Methods


A total of 96 female patients with unilateral ureteric stones were enrolled. Patients underwent ureterorenoscopic lithotripsy, conventional double J (DJ) stent with string and single loop stent with string was placed. Before stent removal at 7-10 days, they were evaluated with X-ray kidney ureter bladder for proximal migration and USSQ for stent-related complaints.
Statistical Analysis Used


Data were analyzed using Chi-square and Student's  t -test.
Results


In our study, Group A (DJ loop with string) had 51 patients and Group B (single J loop with string) had 47 patients. The mean stone size in group A was 10.06 mm and Group B was 9.7 mm. Both groups had one case each of early stent expulsion and none had proximal migration of the stent. Group A had two cases of urinary tract infection and Group B had one case which resolved on antibiotics. Evaluating the USSQ questionnaire in both groups, urinary symptoms such as urgency ( P  = 0.03), dysuria ( P  = 0.02), interference with life ( P  = 0.01), and quality impact overall ( P  = 0.016) were statistically significant. Evaluating pain, sleep disturbance ( P  = 0.04), pain at voiding ( P  = 0.03), and flank pain during voiding ( P  = 0.018) was statistically significant. In general health, difficulty with heavyweight physical activity ( P  = 0.02), feeling calm ( P  = 0.16), social life enjoyment ( P  = 0.26), and need for extra help ( P  = 0.008) was significant. In sexual matters, 13 (28%) patients in Group B had no active sex (conscious) and 6 (12%) patients had stopped intercourse due to stent-related symptoms, whereas in Group A, it was 10 (20%) and 2 (4%) patients, respectively.
Conclusions


The use of a single J stent with string is an effective method, has lesser complication, and is easier to remove.",2021,"Evaluating pain, sleep disturbance ( P  = 0.04), pain at voiding ( P  = 0.03), and flank pain during voiding ( P  = 0.018) was statistically significant.",['96 female patients with unilateral ureteric stones were enrolled'],"['conventional double j stent with string and single loop stent with string after ureterorenoscopy', 'conventional DJ stent and single loop stent with string after ureterorenoscopic lithotripsy', 'ureterorenoscopic lithotripsy, conventional double J (DJ) stent with string and single loop stent with string was placed']","['urinary tract infection', 'social life enjoyment', 'USSQ questionnaire', 'pain at voiding', 'proximal migration of the stent', 'interference with life', 'flank pain during voiding', 'quality impact overall', 'Evaluating pain, sleep disturbance', 'mean stone size', 'early stent expulsion', 'dysuria', 'heavyweight physical activity', 'Ureteral Symptom Score Questionnaire (USSQ', 'feeling calm']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0443313', 'cui_str': 'Stringing'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0016199', 'cui_str': 'Flank pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522165', 'cui_str': 'Feeling calm'}]",96.0,0.073867,"Evaluating pain, sleep disturbance ( P  = 0.04), pain at voiding ( P  = 0.03), and flank pain during voiding ( P  = 0.018) was statistically significant.","[{'ForeName': 'Sonu', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Urology, Renal Transplant and Robotics, Dr D Y Patil Medical College, Pune, Maharastra, India.'}, {'ForeName': 'Vilas', 'Initials': 'V', 'LastName': 'Sabale', 'Affiliation': 'Department of Urology, Renal Transplant and Robotics, Dr D Y Patil Medical College, Pune, Maharastra, India.'}, {'ForeName': 'Abhirudra', 'Initials': 'A', 'LastName': 'Mulay', 'Affiliation': 'Department of Urology, Renal Transplant and Robotics, Dr D Y Patil Medical College, Pune, Maharastra, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Mhaske', 'Affiliation': 'Department of Urology, Renal Transplant and Robotics, Dr D Y Patil Medical College, Pune, Maharastra, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Satav', 'Affiliation': 'Department of Urology, Renal Transplant and Robotics, Dr D Y Patil Medical College, Pune, Maharastra, India.'}, {'ForeName': 'Surya', 'Initials': 'S', 'LastName': 'Nihar', 'Affiliation': 'Department of Urology, Renal Transplant and Robotics, Dr D Y Patil Medical College, Pune, Maharastra, India.'}]",Urology annals,['10.4103/UA.UA_113_20']
2756,34759592,"Assessment of yogic relaxation techniques for its anxiolytic effects in patients requiring endodontic treatment: A prospective, randomized controlled study.","Background


The aim of the study is to assess the anxiolytic effects of yogic relaxation technique (YRT) in patients requiring root canal treatment (RCT).
Materials and Methods


In this prospective, randomized, placebo-controlled study, 30 patients undergoing RCT with baseline visual analog scale for anxiety (VAS-A) of score >4 were divided into Group 1: YRTs; Group 2: alprazolam (0.25 mg/0.5 mg), and Group 3: placebo. After 30 min of completion of YRT, endodontic treatment was performed. Reduction in anxiety was analyzed using state anxiety score (domain) of the state-trait anxiety inventory scale.
Results


There was no significant difference in anxiety score 1 h before RCT between groups ( P  = 0.401). Ten minutes before ( P  < 0.0001) and after RCT ( P  < 0.0001), there was significant difference between groups (yogic relaxation vs. alprazolam [ P  < 0.0001]; yogic relaxation vs. placebo [ P  < 0.0001]). Ten minutes before RCT, yoga relaxation showed significant difference in anxiety score for pain versus alprazolam and placebo ( P  < 0.0001 for both). Ten minutes after RCT, the change from baseline in mean anxiety score for pain was significantly different with yogic relaxation (versus alprazolam [ P  = 0.043]; versus placebo [ P  = 0.002]). As per the global assessment of efficacy, the response was excellent in 9 (90%), 2 (20%), and 1 (10%) patients in yoga relaxation group, alprazolam group, and placebo group, respectively. Difference in response between three groups was significant ( P  < 0.0001). There was no significant difference in the global assessment of tolerability between three groups ( P  = 0.535). No adverse events were reported.
Conclusion


Before RCT, YRT is an effective alternative to anxiolytic agents, alprazolam.",2021,"Ten minutes before RCT, yoga relaxation showed significant difference in anxiety score for pain versus alprazolam and placebo ( P  < 0.0001 for both).","['patients requiring endodontic treatment', 'patients requiring root canal treatment (RCT', '30 patients undergoing RCT with baseline visual analog scale for anxiety (VAS-A) of score >4']","['alprazolam', 'yogic relaxation techniques', 'yogic relaxation technique (YRT', 'placebo']","['Reduction in anxiety', 'global assessment of tolerability', 'adverse events', 'mean anxiety score for pain', 'anxiety score for pain', 'state anxiety score (domain) of the state-trait anxiety inventory scale', 'anxiety score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",30.0,0.0669193,"Ten minutes before RCT, yoga relaxation showed significant difference in anxiety score for pain versus alprazolam and placebo ( P  < 0.0001 for both).","[{'ForeName': 'Meenakshi R', 'Initials': 'MR', 'LastName': 'Verma', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Rahul D', 'Initials': 'RD', 'LastName': 'Rao', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Langade', 'Affiliation': 'Department of Pharmacology, Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Guha', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Malavika', 'Initials': 'M', 'LastName': 'Mohan', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai, Maharashtra, India.'}]",Journal of conservative dentistry : JCD,['10.4103/jcd.jcd_97_21']
2757,34759593,Effect of dental acid etchant-mediated photodynamic therapy on bacterial reduction and microshear bond strength of composite to dentin - An  in vitro  study.,"Objective


The objective of this study was to assess the effect of dental acid etchant (DAE)-mediated photodynamic therapy on bacterial reduction and microshear bond strength of composite to dentin.
Materials and Methods


Eighty permanent third molars after sample preparation were exposed to a cariogenic challenge with  Streptococcus mutans . After incubation, specimens were randomly divided into four groups ( n  = 20): Group I - DAE, Group II - low-level laser (LLL), Group III - diode laser + methylene blue (MB + L), and Group IV - diode laser + DAE (DAE + L). Half of the specimens from each group were selected for bacterial reduction assessment and the other half for microshear bond strength. All the samples for assessment of bacterial reduction (before and after intervention) were seeded onto the surface of mitis-salivarius-bacitracin medium. After incubation, the viable bacterial count was determined in colony-forming unit/mL. For microshear bond strength assessment, samples were subjected to various treatment modalities and then bonding and debonding procedure was performed for blocks of composite and values were recorded.
Results


Significant reductions in  S. mutans  were observed in all the groups - Group I (DAE) 68.50%, Group II (LLL) 55.90%, Group III (MB + L) 88.60%, and Group IV (DAE + L) 87% with comparable bacterial reduction between Group III (MB + L) and Group IV (DAE + L). Furthermore, a significant difference in bond strength values was seen in Group III (MB + L) 10.99 MPa and Group IV (DAE + L) 17.99 MPa whereas an insignificant difference was found between Group I (DAE) 20.74 MPa, Group II (LLL) 18.27 MPa, and Group IV (DAE + L).
Conclusion


DAE caused a comparable reduction in bacterial count to MB-assisted PDT and also there was no adverse effect on bond strength values. PDT can be performed while acid etchant containing MB dye is being applied in the cavity, thus reducing operative time and enhancing cavity disinfection.",2021,"Furthermore, a significant difference in bond strength values was seen in Group III (MB + L) 10.99 MPa and Group IV (DAE + L) 17.99 MPa whereas an insignificant difference was found between Group I (DAE) 20.74 MPa, Group II (LLL) 18.27 MPa, and Group IV (DAE + L).
",[],"['dental acid etchant-mediated photodynamic therapy', 'dental acid etchant (DAE)-mediated photodynamic therapy', 'Group I - DAE, Group II - low-level laser (LLL), Group III - diode laser + methylene blue (MB + L), and Group IV - diode laser + DAE (DAE + L']","['S. mutans', 'viable bacterial count', 'bacterial reduction and microshear bond strength of composite to dentin', 'bond strength values', 'bacterial reduction and microshear bond strength of composite to dentin ']",[],"[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0444619', 'cui_str': 'Etchant'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}]","[{'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0337915,"Furthermore, a significant difference in bond strength values was seen in Group III (MB + L) 10.99 MPa and Group IV (DAE + L) 17.99 MPa whereas an insignificant difference was found between Group I (DAE) 20.74 MPa, Group II (LLL) 18.27 MPa, and Group IV (DAE + L).
","[{'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Gupta', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, I.T.S.-C.D.S.R, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, I.T.S.-C.D.S.R, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Anshi', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Oral Pathology, I.T.S.-C.D.S.R, Ghaziabad, Uttar Pradesh, India.'}]",Journal of conservative dentistry : JCD,['10.4103/JCD.JCD_620_20']
2758,34760067,"Assessing quality of obturation and instrumentation time using Kedo-SG blue, Kedo-SH, and reciprocating hand K-files in primary mandibular molars: A double-blinded randomized controlled trial.","Background


Pulpectomy is the treatment of choice for severely infected primary molars. The aim of the study is to evaluate the instrumentation time and obturation quality using Kedo SG blue, Kedo SH, and reciprocating hand K files in primary mandibular molars. To evaluate the instrumentation time and obturation quality using Kedo-SG blue, Kedo-SH, and reciprocating hand K-files in primary mandibular molars.
Materials and Methods


A double-blinded randomized controlled trial was conducted on 45 mandibular molars and were randomly assigned to three experimental groups ( n  = 15). Group I was instrumented using Kedo-SG blue pediatric rotary files, Group II with Kedo-SH pediatric hand files, and Group III with reciprocating hand K-files. Standardized digital radiographs were taken before and after root canal instrumentation. Root canal preparation time was also recorded. Statistical analysis of the obtained data was done using SPSS software version 17.0. An intergroup comparison of the instrumentation time and the quality of obturation were done using ANOVA and Chi-square test with the level of significance set at 5%.  P  < 0.05 was considered statistically significant.
Results


No significant differences were noted with regard to the quality of obturation between the three groups ( P  < 0.14). However, a statistically significant difference was noted in the instrumentation time between the three groups ( P  = 0.000). Kedo-SG blue rotary file had significantly lesser instrumentation time when compared to that of Kedo-SH hand files and reciprocating hand K-files.
Conclusion


On comparative evaluation,Kedo-SG blue pediatric rotary file showed a marked reduction in instrumentation time, followed by Kedo-SH pediatric hand files and reciprocating hand K-files.",2021,"Kedo-SG blue rotary file had significantly lesser instrumentation time when compared to that of Kedo-SH hand files and reciprocating hand K-files.
","['primary mandibular molars', 'severely infected primary molars', '45 mandibular molars']","['Kedo SG blue, Kedo SH, and reciprocating hand K files', 'Kedo-SG blue, Kedo-SH, and reciprocating hand K-files', 'Kedo-SG blue pediatric rotary files, Group II with Kedo-SH pediatric hand files, and Group III with reciprocating hand K-files']","['quality of obturation', 'instrumentation time', 'Root canal preparation time']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282543', 'cui_str': 'Root canal preparation'}]",45.0,0.12052,"Kedo-SG blue rotary file had significantly lesser instrumentation time when compared to that of Kedo-SH hand files and reciprocating hand K-files.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sruthi', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Jeevanandan', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Govindaraju', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Emg', 'Initials': 'E', 'LastName': 'Subramanian', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, Tamil Nadu, India.'}]",Dental research journal,['10.4103/1735-3327.326649']
2759,34760065,Effects of probiotic and fluoride mouthrinses on  Streptococcus mutans  in dental plaque around orthodontic brackets: A preliminary explorative randomized placebo-controlled clinical trial.,"Background


Although it is shown that probiotic agents might reduce  Streptococcus mutans , no study has evaluated this effect in the form of probiotic mouthrinse. The purpose of this study was to compare the effect of probiotic experimental mouthwash  Lactobacillus plantarum  versus sodium fluoride and placebo mouthwashes on the number of  S. mutans  present in dental plaque around orthodontic brackets in fixed orthodontic patients.
Materials and Methods


This study was a randomized clinical trial. The total of 38 patients participate consisting of 12 patients in the fluoride group, 13 in the probiotic, and 12 in the placebo group. They were given mouthwashes to use twice a day for 2 weeks. Plaque sampling was performed using the 4-pass technique in all three groups in two stages: before the intervention and after 2 weeks of using the mouthwash. The number of bacteria present in the dental plaque was then reported based on the number of colonies grown on agar medium. Data were analyzed using Kruskal-Wallis and Wilcoxon tests (α = 0.05).
Results


Gender distribution, mean age, and protocol adherence were not significantly different among all three groups. After the intervention, the number of  S. mutans  present in the dental plaque followed an increasing manner in the placebo ( P  = 0.005) and probiotic ( P  = 0.158) groups and decreased in fluoride group ( P  = 0.025).
Conclusion


The  L. plantarum  probiotic mouthwash was ineffective in reduction of  S. mutans  in dental plaque. However, fluoride mouthwash is considerably effective against  S. mutans  and thus recommended.",2021,"After the intervention, the number of  S. mutans  present in the dental plaque followed an increasing manner in the placebo ( P  = 0.005) and probiotic ( P  = 0.158) groups and decreased in fluoride group ( P  = 0.025).
","['Streptococcus mutans  in dental plaque around orthodontic brackets', 'dental plaque around orthodontic brackets in fixed orthodontic patients', '38 patients participate consisting of 12 patients in the fluoride group, 13 in the probiotic, and 12 in the placebo group']","['probiotic and fluoride mouthrinses', 'placebo', 'probiotic experimental mouthwash  Lactobacillus plantarum  versus sodium fluoride and placebo mouthwashes', 'fluoride mouthwash']",['number of  S. mutans  present in the dental plaque'],"[{'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0085428', 'cui_str': 'Orthodontic bracket'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",38.0,0.0660317,"After the intervention, the number of  S. mutans  present in the dental plaque followed an increasing manner in the placebo ( P  = 0.005) and probiotic ( P  = 0.158) groups and decreased in fluoride group ( P  = 0.025).
","[{'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Dadgar', 'Affiliation': 'Dental Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Heydarian', 'Affiliation': 'Private Practice, Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Sobouti', 'Affiliation': 'Dental Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Goli', 'Affiliation': 'Molecular And Cell Biology Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Rakhshan', 'Affiliation': 'Private Practice, Tehran, Iran.'}, {'ForeName': 'Mohadeseh', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': 'Dental Implant Research Center, Tehran University of Medical Science, Tehran, Iran.'}]",Dental research journal,['10.4103/1735-3327.326647']
2760,34760062,Evaluation effect of color in dental office and dentist's uniform while using two different distraction techniques on injection anxiety of 6-9 years' old children referring to Hamedan Dental School: Randomized clinical trial.,"Background


The management of children's anxiety in dental offices is still a challenge for the treatment team. The most important factors which affect children's dental anxiety are the clinician-related factors and the physical factors of the dental operatory. Color is an environmental factor whose relationship with the perceptive and emotional factors of children has been reported. On the other hand, distraction is essential factors in a treatment environment that can be used to manage children's anxiety.
Materials and Methods


In this randomized clinical trial study, from 132 6 to 9 years of age children, 52.3% were male, and 47.7% were female, with a mean age of 7.45 ± 1.1 years. The children's anxiety levels were determined using the Venham Picture Test and pulse oximetry before and after the administration of local anesthesia. The children were randomly assigned to two groups ( n  = 66): Group 1, music, and Group 2, animated cartoons. The data were analyzed with SPSS 25, using descriptive statistics and the statistical tests consisting of one-way analysis of variance (ANOVA),  t -test, and repeated-measures ANOVA, followed by Tukey honestly significant difference tests. Statistical significance was set at  P  < 0.05.
Results


The anxiety levels were the lowest in the blue and pink environments and the highest in the black and red. Anxiety levels between different colors in terms of physiologic markers and the questionnaire in each distraction technique at different intervals was significantly different.
Conclusion


The use of blue, pink, green, and yellow for dentists' attire, and the interior design of the dental operatory decreased the child patients' anxiety.",2021,"Anxiety levels between different colors in terms of physiologic markers and the questionnaire in each distraction technique at different intervals was significantly different.
","['from 132 6 to 9 years of age children, 52.3% were male, and 47.7% were female, with a mean age of 7.45 ± 1.1 years', ""child patients' anxiety"", ""6-9 years' old children referring to Hamedan Dental School"", ""children's anxiety in dental offices""]",['distraction techniques'],"['Anxiety levels', ""children's anxiety levels"", 'injection anxiety', 'anxiety levels']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0011386', 'cui_str': 'Dental Office'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0182751,"Anxiety levels between different colors in terms of physiologic markers and the questionnaire in each distraction technique at different intervals was significantly different.
","[{'ForeName': 'Rezvan', 'Initials': 'R', 'LastName': 'Rafatjou', 'Affiliation': 'Department of Pediatric Dentistry, Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Dental School, Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farhadian', 'Affiliation': 'Department of Biostatistics, Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Niloofar Entezari', 'Initials': 'NE', 'LastName': 'Moghadam', 'Affiliation': 'Department of Dental School, Hamedan University of Medical Sciences, Hamedan, Iran.'}]",Dental research journal,['10.4103/1735-3327.326644']
2761,34760020,"Effect of Garlic ( Allium sativum ) Supplementation on Premenstrual Disorders: A Randomized, Double-Blind, Placebo-Controlled Trial.","Background


Premenstrual disorders involve physical, behavioral, and mood variations that affect women of childbearing age and interfere with family relationships, household responsibilities, professional duties, and social activities.
Objectives


Considering the side effects of conventional medications, their use is not recommended except in severe cases of premenstrual disorders. Nowadays, there is a tendency to use traditional and complementary medicine that offers various treatments. The purpose of the current study was to investigate the impacts of garlic as a herbal medicine on the severity of premenstrual symptoms.
Methods


This study was a double-blind, randomized, controlled trial. After identification of participants with moderate-to-severe PMS through the premenstrual symptoms screening tools questionnaire (PSST), they were randomly assigned to placebo ( n  = 64) or garlic ( n  = 65) groups. Each participant received one tablet daily for three consecutive cycles and logged the severity of their symptoms in the PSST questionnaire during the intervention period.
Results


There was no significant difference between the two groups in the baseline level of premenstrual symptoms before the intervention. After treatment with garlic for three consecutive cycles, the total score of the severity of premenstrual symptoms significantly ( P  < 0.001) reduced from 34.09 ± 7.31 to 11.21 ± 7.17. In the placebo group, this score changed from 33.35 ± 7.96 to 24.28 ± 7.22. The difference between mean changes in the two groups was 13.78, with a 95% Confidence Interval (CI) of 11.23-16.33. No serious side effects were observed in either group.
Conclusion


Our findings highlight the potential effect of garlic in reducing the severity of premenstrual symptoms; therefore, the use of garlic can be considered as an alternative therapy in the prevention and treatment of premenstrual disorders.",2021,"No serious side effects were observed in either group.
","['participants with moderate-to-severe PMS through the premenstrual symptoms screening tools questionnaire (PSST', 'Premenstrual Disorders']","['Placebo', 'placebo', 'Garlic ( Allium sativum ) Supplementation', 'garlic']","['serious side effects', 'total score of the severity of premenstrual symptoms', 'baseline level of premenstrual symptoms']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0232959', 'cui_str': 'Premenstrual symptom'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0520676', 'cui_str': 'Premenstrual dysphoric disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}, {'cui': 'C0993630', 'cui_str': 'Garlic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0232959', 'cui_str': 'Premenstrual symptom'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.458645,"No serious side effects were observed in either group.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jafari', 'Affiliation': 'Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Tabarrai', 'Affiliation': 'Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Abbassian', 'Affiliation': 'Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Jafari', 'Affiliation': 'Social Medicine, Department of Health and Community Medicine, School of Medicine, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Ayati', 'Affiliation': 'Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/9965064']
2762,34759989,Malus domestica  reduces chemotherapy-induced nausea and vomiting: A randomized double-blind placebo-controlled clinical trial.,"Background


Chemotherapy-induced nausea and vomiting (CINV) is considered as the most common complications of chemotherapy which has a detrimental influence on the quality of life of patients with cancer. We assessed the efficacy of Apple ( Malus domestica ) syrup for reducing CINV.
Materials and Methods


This study was a randomized, double-blind, placebo-controlled trial carried out in a Hematooncology Clinic affiliated to Mazandaran University of Medical Sciences, Sari, Iran (from October 2017 to August 2018). Subjects were randomly allocated to receive apple syrup or placebo along with their previous antiemetic treatment and chemotherapy regimen, three times a day. Thirty-four patients received apple syrup ( n  = 16) or placebo ( n  = 18). Statistical analysis was conducted using SPSS software Version 21 ®  (SPSS Inc., Chicago, IL, USA). A  P  < 0.05 indicated statistical significance.
Results


Both acute and delayed nausea grades were significantly lower in  M. domestica  syrup in comparison to placebo syrup ( P  = 0.001 and 0.001, respectively). The duration of nausea ( P  = 0.04) was lower in intervention group compared to placebo group.
Conclusion


These findings demonstrated that  M. domestica  syrup can reduce the severity and duration of nausea in cancer patients who received chemotherapy.",2021,Both acute and delayed nausea grades were significantly lower in  M. domestica  syrup in comparison to placebo syrup (,"['cancer patients who received chemotherapy', 'a Hematooncology Clinic affiliated to Mazandaran University of Medical Sciences, Sari, Iran (from October 2017 to August 2018', 'patients with cancer']","['Apple ( Malus domestica ) syrup', 'placebo syrup ', 'placebo', 'apple syrup or placebo', 'apple syrup']","['severity and duration of nausea', 'delayed nausea grades', 'nausea and vomiting (CINV', 'nausea and vomiting', 'duration of nausea']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0443055', 'cui_str': 'Sari - microbial strain'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0330653', 'cui_str': 'Malus domestica'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}]",,0.612609,Both acute and delayed nausea grades were significantly lower in  M. domestica  syrup in comparison to placebo syrup (,"[{'ForeName': 'Sharareh', 'Initials': 'S', 'LastName': 'Darvishpour', 'Affiliation': 'Department of Clinical Pharmacy, Gastrointestinal Cancer Research Center, Student Research Committee, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Avan', 'Affiliation': 'Department of Clinical Pharmacy, Medical Toxicology and Drug Abuse Research Center (MTDRC), School of Pharmacy, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Azadbakht', 'Affiliation': 'Department of Pharmacognosy, Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Monireh', 'Initials': 'M', 'LastName': 'Maham', 'Affiliation': 'Department of Clinical Pharmacy, Student Research Committee, Resident of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Akbari', 'Affiliation': 'Department of Pharmaceutics, Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Janbabaei', 'Affiliation': 'Department of Hematology and Oncology, Gastrointestinal Cancer Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Zaboli', 'Affiliation': 'Department of Hematology and Oncology, Gastrointestinal Cancer Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Amirabadizadeh', 'Affiliation': 'Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Department of Clinical Pharmacy, Pharmaceutical Sciences Research Center, Hemoglobinopathy Institute, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_833_20']
2763,34759933,"Clinical Immunogenicity Evaluation of Eptinezumab, a Therapeutic Humanized Monoclonal Antibody Targeting Calcitonin Gene-Related Peptide (CGRP) for the Preventive Treatment of Migraine.","Background


Eptinezumab is a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide and is indicated for the preventive treatment of migraine in adults. This analysis characterizes the immunogenic profile of eptinezumab using data from clinical trials of eptinezumab for migraine prevention.
Methods


Immunogenicity data were collected from five studies that included 2076 patients with episodic or chronic migraine treated with eptinezumab at dose levels ranging from 10 to 1000 mg, administered intravenously for up to 4 doses at 12-week intervals. Anti-drug antibody (ADA) results were available from 2074 of these patients. Four studies were randomized, double-blind, placebo-controlled trials with ADA monitoring for up to 56 weeks; one was a 2-year, open-label, phase 3 safety study with ADA monitoring for 104 weeks. Patients who had a confirmed ADA-positive result at the end-of-study visit were monitored for up to 6 additional months. Development of ADA and neutralizing antibodies (NAbs) were evaluated to explore three key areas of potential impact: pharmacokinetic exposure profile (eptinezumab trough plasma concentrations), efficacy (change in monthly migraine days), and safety (rates of treatment-emergent adverse events). These studies included methods designed to capture the dynamics of a potential humoral immune response to eptinezumab treatment, and descriptive analyses were applied to interpret the relationship of ADA signals to drug exposure, efficacy, and safety.
Results


Pooled across the five clinical trials, treatment-emergent ADAs and NAbs occurred in 15.8 and 6.2% of eptinezumab-treated patients, respectively. Highly consistent profiles were observed across all studies, with initial onset of detectable ADA observed at the week 8 measurement and maximal ADA frequency and titer observed at week 24, regardless of eptinezumab dose level or number of doses. After 24 weeks, the ADA and NAb titers steadily declined despite additional doses of eptinezumab.
Interpretation


Collectively, these integrated analyses did not demonstrate any clinically meaningful impact from ADA occurring after treatment with eptinezumab. The ADA profiles were low titer and transient, with the incidence and magnitude of ADA or NAb responses declining after week 24. Development of ADAs and NAbs did not impact the efficacy and safety profiles of eptinezumab.",2021,"The ADA profiles were low titer and transient, with the incidence and magnitude of ADA or NAb responses declining after week 24.","['Patients who had a confirmed ADA-positive result at the end-of-study visit', '2076 patients with episodic or chronic migraine treated with']","['eptinezumab', 'placebo', 'Eptinezumab']","['ADA and NAb titers', 'ADA or NAb responses', 'maximal ADA frequency and titer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C4694272', 'cui_str': 'eptinezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",2076.0,0.214396,"The ADA profiles were low titer and transient, with the incidence and magnitude of ADA or NAb responses declining after week 24.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pederson', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, United States.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Biondi', 'Affiliation': 'Alder BioPharmaceuticals, Inc. (CKA Lundbeck Seattle BioPharmaceuticals, Inc.), Bothell, WA, United States.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Allan', 'Affiliation': 'Alder BioPharmaceuticals, Inc. (CKA Lundbeck Seattle BioPharmaceuticals, Inc.), Bothell, WA, United States.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schaeffler', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Baker', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Latham', 'Affiliation': 'Alder BioPharmaceuticals, Inc. (CKA Lundbeck Seattle BioPharmaceuticals, Inc.), Bothell, WA, United States.'}]",Frontiers in immunology,['10.3389/fimmu.2021.765822']
2764,34760321,Assessment of Shoulder Function after Internal Fixation of Humeral Diaphyseal Fractures in Young Adults: A Prospective Comparative Study.,"Background


Humeral shaft fractures are commonly encountered in casualties. There are different methods of operative internal fixation with no consensus on the best technique. The objective of this study was to assess shoulder function and rate of complications among two different options of fixation, intramedullary nailing, and minimal invasive plate osteosynthesis (MIPO) in young adults.
Methods


Forty-two patients with humeral shaft fractures were included in the study and divided into two equal groups: group A treated with antegrade intramedullary locked nails (IMN) and group B with MIPO. Fracture union was evaluated with serial X-rays, and shoulder function was assessed in both groups using the scale of the American Shoulder and Elbow Surgeons (ASES), University of California at Los Angeles Shoulder Scale (UCLA), and visual analog score (VAS). The mean differences between groups were recorded and considered significant if the  P  value was ˂0.05.
Results


The results were reported prospectively with no significant differences in mean age, sex, side of injury, type of fracture, mechanism of injury, and the follow-up period between the groups studied. Group A had shorter operative time and minimal blood loss than group B. Regarding shoulder function scores (ASES, UCLA, and VAS), the results in the MIPO group were better than the IMN group with shorter time of union and fewer complications.
Conclusion


Despite a shorter operative time and lower blood loss during locked intramedullary nail fixation in the management of humeral shaft fractures, MIPO enables more superior shoulder function with better fracture healing and lower morbidities.",2021,Group A had shorter operative time and minimal blood loss than,"['Humeral Diaphyseal Fractures in Young Adults', 'young adults', 'Methods\n\n\nForty-two patients with humeral shaft fractures']","['antegrade intramedullary locked nails (IMN) and group B with MIPO', 'fixation, intramedullary nailing, and minimal invasive plate osteosynthesis (MIPO', 'IMN', 'locked intramedullary nail fixation']","['Shoulder Function', 'operative time and lower blood loss', 'shoulder function and rate of complications', 'shoulder function scores (ASES, UCLA, and VAS', 'Fracture union', 'shorter operative time and minimal blood loss', 'time of union and fewer complications', 'American Shoulder and Elbow Surgeons (ASES), University of California at Los Angeles Shoulder Scale (UCLA), and visual analog score (VAS']","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}]","[{'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0441226', 'cui_str': 'Locking nail'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C4727954', 'cui_str': 'Plate osteosynthesis'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205388', 'cui_str': 'Few'}]",42.0,0.00708236,Group A had shorter operative time and minimal blood loss than,"[{'ForeName': 'Hossam Fathi', 'Initials': 'HF', 'LastName': 'Mahmoud', 'Affiliation': 'Orthopedic Surgery Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ahmed Hatem', 'Initials': 'AH', 'LastName': 'Farhan', 'Affiliation': 'Orthopedic Surgery Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Fahmy Samir', 'Initials': 'FS', 'LastName': 'Fahmy', 'Affiliation': 'Orthopedic Surgery Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Advances in orthopedics,['10.1155/2021/9471009']
2765,34747972,Effectiveness of a Multifaceted Intervention for Prevention of Obesity in Primary School Children in China: A Cluster Randomized Clinical Trial.,"Importance


A rapid nutritional transition has caused greater childhood obesity prevalence in many countries, but the repertoire of effective preventive interventions remains limited.
Objective


To determine the effectiveness of a novel multifaceted intervention for obesity prevention in primary school children.
Design, Setting, and Participants


A cluster randomized clinical trial was conducted during a single school year (from September 11, 2018, to June 30, 2019) across 3 socioeconomically distinct regions in China according to a prespecified trial protocol. Twenty-four schools were randomly allocated (1:1) to the intervention or the control group, with 1392 eligible children aged 8 to 10 years participating. Data from the intent-to-treat population were analyzed from October 1 to December 31, 2019.
Interventions


A multifaceted intervention targeted both children (promoting healthy diet and physical activity) and their environment (engaging schools and families to support children's behavioral changes). The intervention was novel in its strengthening of family involvement with the assistance of a smartphone app. The control schools engaged in their usual practices.
Main Outcomes and Measures


The primary outcome was the change in body mass index (BMI; calculated as weight in kilograms divided by height in square meters) from baseline to the end of the trial. Secondary outcomes included changes in adiposity outcomes (eg, BMI z score, prevalence of obesity), blood pressure, physical activity and dietary behaviors, obesity-related knowledge, and physical fitness. Generalized linear mixed models were used in the analyses.
Results


Among the 1392 participants (mean [SD] age, 9.6 [0.4] years; 717 boys [51.5%]; mean [SD] BMI, 18.6 [3.7]), 1362 (97.8%) with follow-up data were included in the analyses. From baseline to the end of the trial, the mean BMI decreased in the intervention group, whereas it increased in the control group; the mean between-group difference in BMI change was -0.46 (95% CI, -0.67 to -0.25; P < .001), which showed no evidence of difference across different regions, sexes, maternal education levels, and primary caregivers (parents vs nonparents). The prevalence of obesity decreased by 27.0% of the baseline figure (a relative decrease) in the intervention group, compared with 5.6% in the control group. The intervention also improved other adiposity outcomes, dietary, sedentary, and physical activity behaviors, and obesity-related knowledge, but it did not change moderate- to vigorous-intensity physical activity, physical fitness, or blood pressure. No adverse events were observed during the intervention.
Conclusions and Relevance


The multifaceted intervention effectively reduced the mean BMI and obesity prevalence in primary school children across socioeconomically distinct regions in China, suggesting its potential for national scaling.
Trial Registration


ClinicalTrials.gov Identifier: NCT03665857.",2021,"The prevalence of obesity decreased by 27.0% of the baseline figure (a relative decrease) in the intervention group, compared with 5.6% in the control group.","['1392 eligible children aged 8 to 10 years participating', 'primary school children', 'primary school children across socioeconomically distinct regions in China', 'single school year (from September 11, 2018, to June 30, 2019) across 3 socioeconomically distinct regions in China according to a prespecified trial protocol', 'Twenty-four schools', 'Primary School Children in China', '1392 participants (mean [SD] age, 9.6 [0.4] years; 717 boys [51.5%]; mean [SD] BMI, 18.6 [3.7]), 1362 (97.8%) with follow-up data were included in the analyses']","['novel multifaceted intervention', 'multifaceted intervention targeted both children (promoting healthy diet and physical activity', 'Multifaceted Intervention']","['mean BMI and obesity prevalence', 'adiposity outcomes, dietary, sedentary, and physical activity behaviors, and obesity-related knowledge, but it did not change moderate- to vigorous-intensity physical activity, physical fitness, or blood pressure', 'change in body mass index (BMI; calculated as weight in kilograms divided by height in square meters', 'adverse events', 'prevalence of obesity', 'mean BMI', 'BMI change', 'changes in adiposity outcomes (eg, BMI z score, prevalence of obesity), blood pressure, physical activity and dietary behaviors, obesity-related knowledge, and physical fitness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0457242', 'cui_str': 'sq. m'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",1392.0,0.174521,"The prevalence of obesity decreased by 27.0% of the baseline figure (a relative decrease) in the intervention group, compared with 5.6% in the control group.","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, National Health Commission Key Laboratory of Reproductive Health, Beijing, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Ai-Yu', 'Initials': 'AY', 'LastName': 'Gao', 'Affiliation': 'Dongcheng Primary and Secondary School Health Care Center, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Urumqi Primary and Secondary School Health Care Center, Xinjiang, China.'}, {'ForeName': 'Xiang-Xian', 'Initials': 'XX', 'LastName': 'Feng', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Mentougou Primary and Secondary School Health Care Center, Beijing, China.'}, {'ForeName': 'Li-Qun', 'Initials': 'LQ', 'LastName': 'Xu', 'Affiliation': 'Center of Excellence for mHealth and Smart Healthcare, China Mobile Research Institute, China Mobile Communications Corporation, Beijing, China.'}, {'ForeName': 'Wen-Yi', 'Initials': 'WY', 'LastName': 'Niu', 'Affiliation': 'Department of Social Medicine and Health Education, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'China Center for Health Development Studies, Peking University, Beijing, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, National Health Commission Key Laboratory of Reproductive Health, Beijing, China.'}, {'ForeName': 'Wen-Hao', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, National Health Commission Key Laboratory of Reproductive Health, Beijing, China.'}, {'ForeName': 'Jian-Hui', 'Initials': 'JH', 'LastName': 'Yuan', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Chun-Xia', 'Initials': 'CX', 'LastName': 'Xu', 'Affiliation': 'Urumqi Primary and Secondary School Health Care Center, Xinjiang, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Center of Excellence for mHealth and Smart Healthcare, China Mobile Research Institute, China Mobile Communications Corporation, Beijing, China.'}, {'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'Wen', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'George C', 'Initials': 'GC', 'LastName': 'Patton', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Hai-Jun', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, National Health Commission Key Laboratory of Reproductive Health, Beijing, China.'}, {'ForeName': 'Yang-Feng', 'Initials': 'YF', 'LastName': 'Wu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2021.4375']
2766,34747925,Ivabradine versus bisoprolol in the treatment of inappropriate sinus tachycardia: a long-term follow-up study.,"AIM


The aim of our study was to compare ivabradine versus bisoprolol in the short-term and long-term treatment of inappropriate sinus tachycardia.
METHODS


From this prospective, parallel-group, open-label study, consecutive patients affected by inappropriate sinus tachycardia received ivabradine or bisoprolol and were evaluated with Holter ECG, ECG stress test, European Heart Rhythm Association score and Minnesota Living With Heart Failure Questionnaire at baseline, after 3 and 24 months.
RESULTS


Overall, 40 patients were enrolled. Baseline parameters were comparable in the ivabradine and bisoprolol subgroups. Two patients had transient phosphenes with ivabradine and two others interrupted the drug after 3 months as they planned to become pregnant. Eight individuals treated with bisoprolol experienced hypotension and weakness, which caused drug discontinuation in five of them. Ivabradine was superior to bisoprolol in reducing Holter ECG mean heart rate (HR) and mean HR during daytime at short- and long-term follow-up. Moreover, ivabradine but not bisoprolol significantly reduced Holter ECG mean HR during night-time as well as maximal and minimal HR and significantly increased the time duration and maximal load reached at ECG stress test. The quality of life questionnaires significantly improved in both subgroups.
CONCLUSION


This study suggests that ivabradine is better tolerated than bisoprolol and seems to be superior in controlling the heart rate and improving exercise capacity in a small population of individuals affected by inappropriate sinus tachycardia during a short-term and long-term follow-up.",2021,"The quality of life questionnaires significantly improved in both subgroups.
","['inappropriate sinus tachycardia', '40 patients were enrolled']","['Ivabradine versus bisoprolol', 'Ivabradine', 'ivabradine', 'ivabradine versus bisoprolol', 'ivabradine or bisoprolol']","['hypotension and weakness', 'quality of life questionnaires', 'Holter ECG mean heart rate (HR) and mean HR during daytime', 'Holter ECG mean HR', 'Holter ECG, ECG stress test, European Heart Rhythm Association score and Minnesota Living With Heart Failure Questionnaire', 'time duration and maximal load', 'heart rate and improving exercise capacity']","[{'cui': 'C1881170', 'cui_str': 'Inappropriate sinus tachycardia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C1304755', 'cui_str': 'Electrocardiogram with exercise test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",40.0,0.0244651,"The quality of life questionnaires significantly improved in both subgroups.
","[{'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Martino', 'Affiliation': 'Division of Cardiology, Policlinic Casilino.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rebecchi', 'Affiliation': 'Division of Cardiology, Policlinic Casilino.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Sette', 'Affiliation': 'Division of Cardiology, Policlinic Casilino.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cicogna', 'Affiliation': 'Division of Cardiology, Policlinic Casilino.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Politano', 'Affiliation': 'Division of Cardiology, Policlinic Casilino.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Sgueglia', 'Affiliation': 'Division of Cardiology, Policlinic Casilino.'}, {'ForeName': 'Ermenegildo', 'Initials': 'E', 'LastName': 'de Ruvo', 'Affiliation': 'Division of Cardiology, Policlinic Casilino.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Volterrani', 'Affiliation': 'Cardiology Department, IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': ""Calo'"", 'Affiliation': 'Division of Cardiology, Policlinic Casilino.'}]","Journal of cardiovascular medicine (Hagerstown, Md.)",['10.2459/JCM.0000000000001203']
2767,34747917,Botulinum Toxin Injection Plus Topical Diltiazem for Chronic Anal Fissure: A Randomized Double-Blind Clinical Trial and Long-term Outcome.,"BACKGROUND


Chemical sphincterotomy avoids the risk of permanent incontinence in the treatment of chronic anal fissure, but it does not reach the efficacy of surgery and recurrence is high. Drug combination has been proposed to overcome these drawbacks.
OBJECTIVE


This study aimed to compare the clinical, morphological, and functional effects of combined therapy with botulinum toxin injection and topical diltiazem in chronic anal fissure and to assess the long-term outcome after healing.
DESIGN


This is a randomized, controlled, double-blind, 2-arm, parallel-group trial with a long-term follow-up.
SETTINGS


This study was conducted at a tertiary care center.
PATIENTS


A total of 70 consecutive patients were referred to the gastroenterology department of a hospital in Valencia, Spain.
INTERVENTION


After botulinum toxin injection (20 IU), patients were randomly assigned to local diltiazem (diltiazem group) or placebo gel (placebo group) for 12 weeks.
MAIN OUTCOME MEASURES


The primary outcome was fissure healing (evaluated by video register by 3 independent physicians). Secondary outcomes included symptomatic relief (30-day diary), effect on anal sphincters (manometry), safety, and long-term recurrence (24 months and 10 years).
RESULTS


Healing was achieved per protocol in 13 of 25 (52%) patients of the diltiazem group and 11 of 30 (36.7%) patients of the placebo group (p = 0.25); on an intention-to-treat basis in 37.1% and 31.4% (p = 0.61). Both groups displayed significant reduction of anal pressures. Thirty percent reported minor and transitory incontinence, without differences between groups. Nine (69.2%) of the diltiazem group and 6 (54.5%) of the placebo group experienced a relapse at 24 months (p = 0.67). The overall recurrence rate at 10 years was 83.3% (20/24 patients).
LIMITATIONS


This study was limited by the loss of patients during the trial. The low healing rate led to a small cohort to assess recurrence.
CONCLUSIONS


Combined botulinum toxin injection and topical diltiazem is not superior to botulinum toxin injection in the treatment of chronic anal fissure. Both options offer suboptimal healing rates. Long-term recurrence is high (>80% at 10 years) and might appear at any time after healing. See Video Abstract at http://links.lww.com/DCR/B527.
INYECCIN DE TOXINA BOTULNICA MS DILTIAZEM TPICO EN FISURA ANAL CRNICA UN ENSAYO CLNICO ALEATORIZADO DOBLE CIEGO Y RESULTADOS A LARGO PLAZO


ANTECEDENTES:La esfinterotomía química evita el riesgo de incontinencia permanente en el tratamiento de la fisura anal crónica, pero no alcanza la eficacia de la cirugía y la recurrencia es alta. Se ha propuesto la combinación de fármacos para superar estos inconvenientes.OBJETIVO:Comparar los efectos clínicos, morfológicos y funcionales de la terapia combinada con inyección de toxina botulínica y diltiazem tópico en fisura anal crónica y evaluar el resultado a largo plazo después de la cicatrización.DISEÑO:Ensayo aleatorizado, controlado, doble ciego, de dos brazos, de grupos paralelos con un seguimiento a largo plazo.ESCENARIO:Estudio realizado en un centro de atención terciaria.PACIENTES:Un total de 70 pacientes consecutivos referidos al servicio de gastroenterología de un hospital de Valencia, España.INTERVENCIÓN:Después de la inyección de toxina botulínica (20UI), los pacientes fueron asignados al azar a diltiazem local (grupo de diltiazem) o gel de placebo (grupo de placebo) durante 12 semanas.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue la cicatrización de la fisura (evaluado por registro de video por tres médicos independientes). Los resultados secundarios incluyeron alivio sintomático (diario de 30 días), efecto sobre los esfínteres anales (manometría), seguridad y recurrencia a largo plazo (24 meses y 10 años).RESULTADOS:La curación se logró por protocolo en 13/25 (52%) en el grupo de Diltiazem y 11/30 (36,7%) en el grupo de Placebo (p = 0.25); por intención de tratar en el 37.1% y el 31.4%, respectivamente (p = 0.61). Ambos grupos mostraron una reducción significativa de las presiones anales. El 30% refirió incontinencia leve y transitoria, sin diferencias entre grupos. 9 (69.2%) del grupo de Diltiazem y 6 (54.5%) del grupo de placebo recurrieron a los 24 meses (p = 0.67). La tasa global de recurrencia a los 10 años fue del 83.3% (20/24 pacientes).LIMITACIONES:La pérdida de pacientes a lo largo del ensayo. La baja tasa de curación llevó a una pequeña cohorte para evaluar la recurrencia.CONCLUSIONES:La inyección combinada de toxina botulínica y diltiazem tópico no es superior a la inyección de TB en el tratamiento de la fisura anal crónica. Ambas opciones ofrecen tasas de curación subóptimas. La recurrencia a largo plazo es alta (> 80% a los 10 años) y puede aparecer en cualquier momento después de la curación. Consulte Video Resumen en http://links.lww.com/DCR/B527.",2021,La inyección combinada de toxina botulínica y diltiazem tópico no es superior a la inyección de TB en el tratamiento de la fisura anal crónica.,"['Chronic Anal Fissure', 'y funcionales', '70 consecutive patients were referred to the gastroenterology department of a hospital in Valencia, Spain', 'y 10 años).RESULTADOS', 'de toxina botulínica y diltiazem tópico en fisura anal crónica', 'chronic anal fissure']","['con inyección', 'DISEÑO', 'o gel de placebo (grupo de placebo', 'Placebo', 'botulinum toxin injection', 'alcanza', 'botulinum toxin injection and topical diltiazem', 'placebo', 'Botulinum Toxin Injection Plus Topical Diltiazem', 'Diltiazem', 'diltiazem local (grupo de diltiazem', 'local diltiazem (diltiazem group) or placebo gel (placebo', 'diltiazem']","['symptomatic relief (30-day diary), effect on anal sphincters (manometry), safety, and long-term recurrence', 'Healing', 'La tasa global de recurrencia', 'transitory incontinence', 'anal pressures', 'fissure healing', 'overall recurrence rate', 'low healing rate', 'chronic anal fissure']","[{'cui': 'C0349071', 'cui_str': 'Chronic anal fissure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0587464', 'cui_str': 'Gastroenterology department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0002760', 'cui_str': 'Structure of sphincter ani muscle'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0349071', 'cui_str': 'Chronic anal fissure'}]",70.0,0.197335,La inyección combinada de toxina botulínica y diltiazem tópico no es superior a la inyección de TB en el tratamiento de la fisura anal crónica.,"[{'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Herreros', 'Affiliation': 'Department of Gastroenterology, Hospital de Villajoyosa, Alicante, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Espi', 'Affiliation': 'Department of General Surgery, Hospital Clínico Universitario, University of Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Montón Rodriguez', 'Affiliation': 'Department of Gastroenterology, Hospital Clínico Universitario, University of Valencia, Spain.'}, {'ForeName': 'Eduardo García-', 'Initials': 'EG', 'LastName': 'Granero', 'Affiliation': 'Digestive Surgery Unit, Department of General Surgery, Hospital Universitario y Politecnico La Fe, University of Valencia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Sanchiz', 'Affiliation': 'Department of Pharmacy, Hospital Clínico Universitario de Valencia, Spain.'}, {'ForeName': 'Francisco L', 'Initials': 'FL', 'LastName': 'Ferriols', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Castellón, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Almela', 'Affiliation': 'Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Hernandez', 'Affiliation': 'Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Mora', 'Affiliation': 'Department of Pharmacy, Hospital Clínico Universitario de Valencia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Mínguez', 'Affiliation': 'Department of Pharmacy, Hospital Clínico Universitario de Valencia, Spain.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001983']
2768,34747891,Deteriorating Patient Training Using Nonimmersive Virtual Reality: A Descriptive Qualitative Study.,"Recent nurse education pedagogical strategies are starting to embrace the use of virtual patient simulations in higher education settings. This study evaluated student, simulation technician, and lecturer perspectives on student performance after virtual training for care of a deteriorating diabetic patient. Second year nursing students learned using a virtual patient simulation, which was a follow-up of a randomized controlled trial that took place during the academic year 2017-2018. Group and individual interviews were conducted comprising the 21 staff and students involved in the virtual reality simulation in four individual lecture sessions. Five themes emerged from this study: engagement, immersion, confidence, knowledge, and challenges. Student participants found that the virtual reality exercise aided their understanding of the complex concepts associated with hypoglycemia, provided immediate feedback about their clinical decisions, could be completed multiple times, and provided more opportunities for safe practice, complimenting their ward and clinical skills experiences. Simulation technicians and lecturing staff also recognized these benefits but identified challenges, including time and cost constraints. We recommend further research into potential benefits and challenges, including likely consequences of increased use of virtual reality technologies for nurse education curriculum design.",2021,Group and individual interviews were conducted comprising the 21 staff and students involved in the virtual reality simulation in four individual lecture sessions.,"['Student participants', 'student performance after virtual training for care of a deteriorating diabetic patient']","['virtual reality exercise', 'Deteriorating Patient Training Using Nonimmersive Virtual Reality']",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0287713,Group and individual interviews were conducted comprising the 21 staff and students involved in the virtual reality simulation in four individual lecture sessions.,"[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Singleton', 'Affiliation': 'Author Affiliations: Bournemouth University, Bournemouth (Drs Singleton, James, Falconer, and Holley); University Hospitals Dorset, Bournemouth (Ms Penfold); University of Portsmouth, Hampshire (Dr Priego-Hernandez); and Daden Limited, Faraday Wharf, Birmingham Innovation Campus, Birmingham, United Kingdom (Mr Burden).'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'James', 'Affiliation': ''}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Penfold', 'Affiliation': ''}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Falconer', 'Affiliation': ''}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Priego-Hernandez', 'Affiliation': ''}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Holley', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burden', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000787']
2769,34748210,Long-term cognitive and pulmonary functions following a lower versus a higher oxygenation target in the HOT-ICU trial - protocol and statistical analysis plan.,"BACKGROUND


Although supplemental oxygen can be lifesaving, liberal oxygen administration causing hyperoxaemia, may be harmful. The targets for oxygenation in patients with acute hypoxaemic respiratory failure acutely admitted to the intensive care unit (ICU) are strongly debated, and consensus on which targets to recommend has not been reached. The Handling Oxygenation Targets in the ICU (HOT-ICU) trial is a multicentre, randomised, parallel-group trial of a lower oxygenation target (arterial partial pressure of oxygen (PaO 2  ) = 8 kPa) versus a higher oxygenation target (PaO 2  = 12 kPa) in adult ICU patients with acute hypoxaemic respiratory failure. In this study, we aim to evaluate the effects of these targets on long-term cognitive and pulmonary function in Danish patients, enrolled in the HOT-ICU trial and surviving to one-year follow-up. We hypothesise that a lower oxygenation target throughout the ICU stay may result in cognitive impairment, whereas a higher oxygenation target may result in impaired pulmonary function.
METHODS


All patients enrolled in the HOT-ICU trial at Danish sites and surviving to one year after randomisation are eligible to participate. The last patient is expected to be included by November 2021. A Repeatable Battery for the Assessment of Neuropsychological Status and a body plethysmography, including diffusion capacity for carbon monoxide, both pre-planned secondary long-term outcomes of the HOT-ICU trial, will be obtained.
CONCLUSION


This study will provide important information on the long-term effects of a lower versus a higher oxygenation target on cognitive and pulmonary function in adult ICU patients with acute hypoxaemic respiratory failure.",2021,"A Repeatable Battery for the Assessment of Neuropsychological Status and a body plethysmography, including diffusion capacity for carbon monoxide, both pre-planned secondary long-term outcomes of the HOT-ICU trial, will be obtained.
","['patients with acute hypoxaemic respiratory failure acutely admitted to the intensive care unit (ICU', 'adult ICU patients with acute hypoxaemic respiratory failure', 'All patients enrolled in the HOT-ICU trial at Danish sites and surviving to one year after randomisation are eligible to participate', 'Danish patients, enrolled in the HOT-ICU trial and surviving to one-year follow-up']",['lower oxygenation target (arterial partial pressure of oxygen (PaO 2  ) = 8 kPa) versus a higher oxygenation target (PaO 2  = 12 kPa'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0205250', 'cui_str': 'High'}]",[],,0.280579,"A Repeatable Battery for the Assessment of Neuropsychological Status and a body plethysmography, including diffusion capacity for carbon monoxide, both pre-planned secondary long-term outcomes of the HOT-ICU trial, will be obtained.
","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Crescioli', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens Østergaard', 'Initials': 'JØ', 'LastName': 'Riis', 'Affiliation': 'Departments of Neurology and Neurosurgery, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Ulla Møller', 'Initials': 'UM', 'LastName': 'Weinreich', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jens Ulrik Staehr', 'Initials': 'JUS', 'LastName': 'Jensen', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Lone Musaeus', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Anne Craveiro', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Kolding Hospital, University of Southern Denmark, Kolding, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Lass', 'Initials': 'TL', 'LastName': 'Klitgaard', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Olav Lilleholt', 'Initials': 'OL', 'LastName': 'Schjørring', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13995']
2770,34748171,Testing a Prostate Cancer Educational Intervention in High-Burden Neighborhoods.,"To better capitalize on our enhanced understanding of prostate cancer (PCa) risk factors, it is important to better understand how knowledge and attitudes contribute to ethnic disparities in PCa outcomes. The goal of this study was to test the impact of a targeted PCa educational intervention vs. a healthy lifestyle educational control intervention on levels of knowledge, concern, and intention to screen for PCa.We recruited 239 men from neighborhoods with the highest PCa burden in Philadelphia. We assigned 118 men from two of the neighborhoods to the control group 121 men from 2 other neighborhoods to the intervention group. Repeated outcome assessment measures were obtained by administering the survey at baseline, post-session, 1 month post-session, and 4 months post-session.We conducted descriptive statistics to characterize the study sample and linear mixed effect regression models to analyze the intervention's effect on the outcomes. At baseline, we observed no differences in the outcomes between the PCa-targeted intervention and healthy lifestyle control groups.We found that knowledge of PCa and intention to screen increased significantly over time for both the control and intervention groups (p ≤ 0.01 at the 4-month follow-up). In contrast, change in the level of PCa concern was only significant for the intervention group immediately post-session and at 1-month follow-up (p = 0.04 and p = 0.01, respectively).This study showed that gathering at-risk men for discussions about PCa or other health concerns may increase their PCa knowledge and intention to talk to a doctor about PCa screening.",2021,We found that knowledge of PCa and intention to screen increased significantly over time for both the control and intervention groups (p ≤ 0.01 at the 4-month follow-up).,"['239 men from neighborhoods with the highest PCa burden in Philadelphia', '118 men from two of the neighborhoods to the control group 121 men from 2 other neighborhoods to the intervention group', 'High-Burden Neighborhoods']","['targeted PCa educational intervention vs. a healthy lifestyle educational control intervention', 'Prostate Cancer Educational Intervention']","['levels of knowledge, concern, and intention to screen for PCa', 'knowledge of PCa and intention to screen increased significantly over time', 'level of PCa concern']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",118.0,0.0303296,We found that knowledge of PCa and intention to screen increased significantly over time for both the control and intervention groups (p ≤ 0.01 at the 4-month follow-up).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Zeigler-Johnson', 'Affiliation': 'Department of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, USA. Charnita.zeigler-johnson@jefferson.edu.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Madsen', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Keith', 'Affiliation': 'Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Glanz', 'Affiliation': 'Perelman School of Medicine and School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Quinn', 'Affiliation': 'Department of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'V N', 'Initials': 'VN', 'LastName': 'Giri', 'Affiliation': 'Department of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bowen', 'Affiliation': 'Cheyney University, Cheyney, PA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sauls', 'Affiliation': 'Delaware Prostate Cancer Coalition, Dover, DE, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Leader', 'Affiliation': 'Department of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-021-01183-5']
2771,34748169,Outcome of parathyroid function after total thyroidectomy when calcium supplementation is administered routinely versus exclusively to symptomatic patients: A prospective randomized clinical trial.,"PURPOSE


Current guidelines for calcium supplementation for parathyroid function recovery after thyroidectomy are based on low-quality evidence. The present trial compared the effects of oral calcium and vitamin D supplementation on the recovery of parathyroid function when administered routinely or exclusively to symptomatic patients.
METHODS


This prospective, randomized, open-label clinical trial analyzed 203 patients who underwent total thyroidectomy and developed hypoparathyroidism on postoperative day 1 (POD1) with median age of 41 years and proportion of women of 77.8%. Participants were randomized to group A (calcium and vitamin D supplementation administered only to symptomatic patients) and group B (routine supplementation). The primary outcome was the incidence of protracted hypoparathyroidism in the two groups. Secondary outcomes included risk factors for postoperative protracted hypoparathyroidism and the incidence of symptomatic hypocalcemia.
RESULTS


The incidence of protracted hypoparathyroidism was not significantly different between group A and group B (11 of 99 vs. 17 of 104, P = 0.280). Parathyroid hormone (PTH) in group B exhibited a better recovery tendency. The incidence of postoperative symptomatic hypocalcemia in group B was significantly lower than group A (26.92% vs. 42.42%, P = 0.020). Independent factors predicting protracted hypoparathyroidism included sex, preoperative serum calcium, and POD1 PTH.
CONCLUSION


Calcium and vitamin D supplementation administered exclusively to symptomatic patients achieved the same effect on protracted hypoparathyroidism as routine supplementation. However, routine supplementation significantly reduced postoperative hypocalcemia. Extra attention is necessary in female patients with high preoperative serum calcium and patients with low POD1 PTH.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (ChiCTR), ChiCTR1900022194. Registered March 30, 2019.",2021,"The incidence of postoperative symptomatic hypocalcemia in group B was significantly lower than group A (26.92% vs. 42.42%, P = 0.020).","['203 patients who underwent total thyroidectomy and developed hypoparathyroidism on postoperative day 1 (POD1) with median age of 41 years and proportion of women of 77.8', 'symptomatic patients', 'female patients with high preoperative serum calcium and patients with low POD1 PTH']","['oral calcium and vitamin D supplementation', 'calcium and vitamin D supplementation administered only to symptomatic patients) and group B (routine supplementation', 'Calcium and vitamin D supplementation', 'Parathyroid hormone (PTH', 'calcium supplementation']","['parathyroid function', 'incidence of protracted hypoparathyroidism', 'recovery of parathyroid function', 'risk factors for postoperative protracted hypoparathyroidism and the incidence of symptomatic hypocalcemia', 'incidence of postoperative symptomatic hypocalcemia', 'protracted hypoparathyroidism', 'postoperative hypocalcemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}]","[{'cui': 'C0030518', 'cui_str': 'Parathyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}]",203.0,0.170188,"The incidence of postoperative symptomatic hypocalcemia in group B was significantly lower than group A (26.92% vs. 42.42%, P = 0.020).","[{'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid & Parathyroid Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Fei', 'Affiliation': 'Department of Thyroid & Parathyroid Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid & Parathyroid Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wei', 'Affiliation': 'Department of Thyroid & Parathyroid Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Jingqiang', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Thyroid & Parathyroid Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Anping', 'Initials': 'A', 'LastName': 'Su', 'Affiliation': 'Department of Thyroid & Parathyroid Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China. suanpingcd120@163.com.'}]",Endocrine,['10.1007/s12020-021-02921-9']
2772,34748164,Cost-Utility Analysis of Discontinuing Antidepressants in England Primary Care Patients Compared with Long-Term Maintenance: The ANTLER Study.,"BACKGROUND


Depression is a common mental health condition with considerable negative impact on health and well-being. Although antidepressants are recommended as first-line treatment, there is limited evidence regarding the cost effectiveness of long-term maintenance antidepressants for preventing relapse.
OBJECTIVES


Our objective was to calculate the mean incremental costs and quality-adjusted life-years (QALYs) over 12 months of discontinuing long-term antidepressant medication in well patients compared with maintenance, using patient-level trial data.
METHODS


We conducted a cost-utility analysis of 478 participants from 150 UK general practices recruited to a randomised, double-blind trial (ANTLER). QALYs were calculated from EQ-5D-5L and 12-Item Short Form survey (SF-12) results, with primary analysis using the EQ-5D-5L value set for England. Resource use was collected from primary care patient electronic medical records and self-completed questionnaires capturing mental-health-related resource use. Costs were calculated by applying standard UK unit costs to resource use. Adjustments were made for baseline variables.
RESULTS


Participants randomised to discontinuation had significantly worse utility scores at 3 months (- 0.032; 95% confidence interval [CI] - 0.053 to - 0.011) but no significant difference in QALYs (- 0.011; 95% CI - 0.026 to 0.003) or costs (£3.11; 95% CI - 41.28 to 47.50) at 12 months. The probability that discontinuation was cost effective compared with maintenance was 12.9% at a threshold of £20,000 per QALY gained.
CONCLUSIONS


Discontinuation of antidepressants was unlikely to be cost effective compared with maintenance for currently well patients on long-term antidepressants. However, this analysis provides no information on the wider impact of antidepressants. Our findings provide information on the potential impact of discontinuing long-term maintenance antidepressants and facilitate improving guidance for shared patient-clinician decision making.
TRIAL REGISTRATION


EudraCT number 2015-004210-26; ISRCTN number ISRCTN15969819.",2021,"The probability that discontinuation was cost effective compared with maintenance was 12.9% at a threshold of £20,000 per QALY gained.
","['478 participants from 150 UK general practices', 'primary care patient electronic medical records and self-completed questionnaires capturing mental-health-related resource use', 'England Primary Care Patients']","['Discontinuing Antidepressants', 'Long-Term Maintenance']","['utility scores', 'mean incremental costs and quality-adjusted life-years (QALYs']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",478.0,0.184567,"The probability that discontinuation was cost effective compared with maintenance was 12.9% at a threshold of £20,000 per QALY gained.
","[{'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Clarke', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK. caroline.clarke@ucl.ac.uk.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Duffy', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences and Hull York Medical School, University of York, York, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Kendrick', 'Affiliation': 'Primary Care Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lanham', 'Affiliation': 'Patient and Public Involvement Collaborator, London, UK.'}, {'ForeName': 'Derelie', 'Initials': 'D', 'LastName': 'Mangin', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Nazareth', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Rachael Maree', 'Initials': 'RM', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}]",Applied health economics and health policy,['10.1007/s40258-021-00693-x']
2773,34742613,Association between self-assessed preoperative level of physical activity and postoperative complications - An observational cohort analysis within a randomized controlled trial (PHYSSURG-C).,"INTRODUCTION


Physical activity has been suggested as a modifiable risk factor for postoperative recovery after major surgery. We aimed to further define the association between self-reported leisure time physical activity and postoperative complications and recovery on a group level.
MATERIALS AND METHODS


An observational cohort analysis was performed within a randomized controlled trial. Patients ≥20 years with colorectal cancer were eligible. Between January 2015 and May 2020, 761 participants were recruited. Leisure time physical activity was self-assessed on a four-grade scale. The primary outcome in this analysis was postoperative complications within 90 days, measured with the comprehensive complication index (CCI). Secondary outcomes were CCI for the index hospital stay, CCI 30 days postoperatively, specific types of complications, length of hospital stay, and self-assessed physical recovery. Analyses were adjusted for gender, age, study center, alcohol consumption, tumor stage, colon/rectal cancer, neoadjuvant therapy, and open or laparoscopic surgery.
RESULTS


Data on preoperative physical activity was available for 614 participants. Participants who reported some physical activity had on average a lower CCI 90 days postoperatively than sedentary participants (odds ratio 0.63, 95% CI 0.43-0.92). Similar patterns were shown for complications during hospital stay and within 30 days. There were trends towards lower risk for several types of complications, reoperations and length of hospital stay but the only difference shown was for respiratory insufficiency.
CONCLUSION


Physically active participants experienced fewer postoperative complications, which suggests the information has a potential prognostic value. The work for increasing physical activity in the general population should continue.",2021,"There were trends towards lower risk for several types of complications, reoperations and length of hospital stay but the only difference shown was for respiratory insufficiency.
","['Between January 2015 and May 2020, 761 participants were recruited', 'Patients ≥20 years with colorectal cancer were eligible', '614 participants']",[],"['complications, reoperations and length of hospital stay', 'postoperative complications within 90 days, measured with the comprehensive complication index (CCI', 'Leisure time physical activity', 'postoperative complications', 'CCI for the index hospital stay, CCI 30 days postoperatively, specific types of complications, length of hospital stay, and self-assessed physical recovery', 'physical activity', 'physical activity and postoperative complications ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],"[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",761.0,0.184295,"There were trends towards lower risk for several types of complications, reoperations and length of hospital stay but the only difference shown was for respiratory insufficiency.
","[{'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Onerup', 'Affiliation': 'Scandinavian Surgical Outcomes Research Group (SSORG), Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Pediatric Oncology, Gothenburg, Sweden. Electronic address: aron.onerup@gu.se.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Angenete', 'Affiliation': 'Scandinavian Surgical Outcomes Research Group (SSORG), Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Surgery, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bock', 'Affiliation': 'Scandinavian Surgical Outcomes Research Group (SSORG), Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Haglind', 'Affiliation': 'Scandinavian Surgical Outcomes Research Group (SSORG), Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Surgery, Gothenburg, Sweden.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2021.10.033']
2774,34742607,Persons from racial and ethnic minority groups receiving medication for opioid use disorder experienced increased difficulty accessing harm reduction services during COVID-19.,"INTRODUCTION


The COVID-19 pandemic collided with the opioid epidemic and longstanding health inequities to exacerbate the disproportionate harms experienced by persons with opioid use disorder (OUD) who self-identify as from racial and ethnic minority groups. Disrupted access to harm reduction services (e.g., naloxone, sterile syringes, recovery support) is one pathway whereby COVID-19 might exacerbate health disparities. We tested the hypothesis that persons receiving medication for opioid use disorder (MOUD) who self-identify as from racial/ethnic minority groups would experience more disruptions in access to harm reduction services than persons identifying as non-Hispanic White, even when controlling for severity of opioid use and sociodemographics (e.g., education, income, biological sex, age).
METHODS


Analyses used data from a cluster randomized trial that had enrolled 188 patients, all of whom had provided baseline data on sociodemographics and severity of opioid use, across eight opioid treatment programs. Data collectors re-contacted participants between May and June 2020 and 133 (71% response rate) agreed to complete a survey about access to harm reduction services.
RESULTS


Twenty-six respondents (20%) identified as from racial/ethnic minority groups (predominantly Black, Hispanic, and/or biracial). Between 7% and 27% of respondents reported disrupted access to harm reduction services. Logistic regressions indicated that persons identifying as from racial/ethnic minority groups were 8-10 times more likely than persons identifying as non-Hispanic White to report reduced access to naloxone and sterile syringes (p < .01), even when accounting for potential confounding variables.
CONCLUSIONS


This report concludes with a discussion of potential outreach strategies and policies to advance more equitable access to essential harm reduction services.",2021,"Disrupted access to harm reduction services (e.g., naloxone, sterile syringes, recovery support) is one pathway whereby COVID-19 might exacerbate health disparities.","['Analyses used data from a cluster randomized trial that had enrolled 188 patients, all of whom had provided baseline data on sociodemographics and severity of opioid use, across eight opioid treatment programs']",['naloxone'],[],"[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}]",[],188.0,0.0757349,"Disrupted access to harm reduction services (e.g., naloxone, sterile syringes, recovery support) is one pathway whereby COVID-19 might exacerbate health disparities.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rosales', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI 02903, USA. Electronic address: robert_rosales@brown.edu.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Janssen', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI 02903, USA. Electronic address: tim_janssen@brown.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Yermash', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI 02903, USA. Electronic address: julia_yermash@brown.edu.'}, {'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Yap', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI 02903, USA. Electronic address: kimberly_yap@brown.edu.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Ball', 'Affiliation': 'Community Health and Implementation Research Program, RTI International, 3040 East Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC 27709-2194, USA. Electronic address: eball@rti.org.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Hartzler', 'Affiliation': 'Alcohol & Drug Abuse Institute, Department of Psychiatry and Behavioral Sciences, University of Washington, 1107 NE 45th St, Seattle, WA 98105, USA. Electronic address: hartzb@uw.edu.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'Community Health and Implementation Research Program, RTI International, 3040 East Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC 27709-2194, USA.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Becker', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI 02903, USA. Electronic address: sara_becker@brown.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2021.108648']
2775,34742669,Effectiveness to promote weight loss maintenance and healthy lifestyle habits of a group educational intervention program in adults with obesity: IGOBE program.,"BACKGROUND


To achieve sustainable weight loss and healthy lifestyle changes is a huge challenge in the fight against obesity. The objective of this study was to evaluate the effectiveness to promote weight loss maintenance and healthy lifestyle habits of a group educational intervention program, Group Intervention in OBEsity (IGOBE), compared with a usual care therapy to lose weight.
METHODS


Patients with obesity (n = 437; 18.5% men, 18-77 years and 40.4 ± 6.7 kg/m 2 ) were randomised into two groups to follow a prospective interventional real-life study: a control group (CG), treated with usual clinical practice, and an intervention group (IG), in which the patients participate in a group intervention program on healthy lifestyle habits with weekly sessions for six weeks, after which a re-evaluation was made at six months and at 12 months of follow-up. After finishing the study dropout rates were 44.6% in CG and 43.4% in IG. Anthropometric, dietetic habits and body composition data were analysed in both groups at the pre-intervention and post-interventions of the subjects by completer's analysis.
RESULTS


At 12 months of following IGOBE program, the IG achieved greater weight loss (-7.1% of the initial weight) than the CG, which exhibited a weight gain (3.0% of the initial weight). The body weight change induced in the IG was accompanied by a reduction in fat mass, particularly visceral fat and waist circumference. Relevantly, the IG adhered to a healthy dietary pattern and changed its eating habits, which correlated with the improvement in body weight.
CONCLUSIONS


Intensive educational group treatment that induces a change of eating habits and adherence to healthy dietary pattern is more effective in a long-term to counteract obesity traits than a standard treatment performed individually. The IGOBE program could be a cost-effective practice in the clinical management of obesity.",2021,"The body weight change induced in the IG was accompanied by a reduction in fat mass, particularly visceral fat and waist circumference.","['Patients with obesity (n = 437; 18.5% men, 18-77 years and 40.4 ± 6.7 kg/m 2 ', 'adults with obesity']","['weight loss maintenance and healthy lifestyle habits of a group educational intervention program', 'control group (CG), treated with usual clinical practice, and an intervention group (IG), in which the patients participate in a group intervention program']","['fat mass, particularly visceral fat and waist circumference', 'body weight change', 'body weight', 'eating habits', 'weight gain', 'weight loss', 'Anthropometric, dietetic habits and body composition data']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",,0.00176342,"The body weight change induced in the IG was accompanied by a reduction in fat mass, particularly visceral fat and waist circumference.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Porca', 'Affiliation': 'Epigenomics in Endocrinology and Nutrition Group, Instituto de Investigación Sanitaria de Santiago (IDIS), Complejo Hospitalario Univeristario de Santiago de Compostela (CHUS/SERGAS), Santiago de Compostela, Spain; Division of Endocrinology, Complejo Hospitalario Universitario de Ferrol (CHUF/SERGAS) and Coruña University, Ferrol, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Rodriguez-Carnero', 'Affiliation': 'Epigenomics in Endocrinology and Nutrition Group, Instituto de Investigación Sanitaria de Santiago (IDIS), Complejo Hospitalario Univeristario de Santiago de Compostela (CHUS/SERGAS), Santiago de Compostela, Spain; Division of Endocrinology and Nutrition, Complejo Hospitalario Universitario de Santiago de Compostela (CHUS/SERGAS), Santiago de Compostela, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Tejera', 'Affiliation': 'Epigenomics in Endocrinology and Nutrition Group, Instituto de Investigación Sanitaria de Santiago (IDIS), Complejo Hospitalario Univeristario de Santiago de Compostela (CHUS/SERGAS), Santiago de Compostela, Spain; Division of Endocrinology, Complejo Hospitalario Universitario de Ferrol (CHUF/SERGAS) and Coruña University, Ferrol, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Andujar', 'Affiliation': 'Division of Endocrinology, Complejo Hospitalario Universitario de Ferrol (CHUF/SERGAS) and Coruña University, Ferrol, Spain.'}, {'ForeName': 'Felipe F', 'Initials': 'FF', 'LastName': 'Casanueva', 'Affiliation': 'Division of Endocrinology and Nutrition, Complejo Hospitalario Universitario de Santiago de Compostela (CHUS/SERGAS), Santiago de Compostela, Spain; Molecular Endocrinology Group, Instituto de Investigacion Sanitaria de Santiago (IDIS), Complejo Hospitalario Universitario de Santiago de Compostela (CHUS/SERGAS), Santiago de Compostela, Spain; Centro de Investigacion Biomedica en Red Fisiopatologia de la Obesidad y Nutricion (CIBERobn), Madrid, Spain.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Crujeiras', 'Affiliation': 'Epigenomics in Endocrinology and Nutrition Group, Instituto de Investigación Sanitaria de Santiago (IDIS), Complejo Hospitalario Univeristario de Santiago de Compostela (CHUS/SERGAS), Santiago de Compostela, Spain; Centro de Investigacion Biomedica en Red Fisiopatologia de la Obesidad y Nutricion (CIBERobn), Madrid, Spain. Electronic address: anabelencrujeiras@hotmail.com.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Bellido', 'Affiliation': 'Epigenomics in Endocrinology and Nutrition Group, Instituto de Investigación Sanitaria de Santiago (IDIS), Complejo Hospitalario Univeristario de Santiago de Compostela (CHUS/SERGAS), Santiago de Compostela, Spain; Division of Endocrinology, Complejo Hospitalario Universitario de Ferrol (CHUF/SERGAS) and Coruña University, Ferrol, Spain. Electronic address: Diego.Bellido.Guerrero@sergas.es.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2021.10.003']
2776,34743118,"Safety and Effectiveness of Hyaluronic Acid Filler, VYC-20L, via Cannula for Cheek Augmentation: A Randomized, Single-Blind, Controlled Study.","BACKGROUND


Using cannulas to deliver facial fillers may reduce adverse events (AEs) compared with needle injection.
OBJECTIVE


To evaluate the safety and effectiveness of VYC-20L (20 mg/mL hyaluronic acid gel with lidocaine) via cannula for midface age-related volume deficit.
MATERIALS AND METHODS


This multicenter, evaluator-blind, randomized, within-subject, controlled study enrolled adults with moderate to severe Mid-Face Volume Deficit Scale (MFVDS) scores. VYC-20L was administered in one cheek via cannula (with optional needle use in the zygomaticomalar region) and in the other cheek via needle. The primary effectiveness end point was the mean (95% confidence interval [CI]) paired difference between treatments in MFVDS score change from baseline to Month 1; an upper CI limit of less than 0.5 determined noninferiority. Injection-site responses (ISRs), procedural pain, and AEs were assessed.
RESULTS


Of 60 randomized and treated subjects, the mean change in MFVDS score from baseline to Month 1 was -1.8 with cannulas and -1.9 with needles, providing a mean (95% CI) paired difference of 0.1 (-0.05 to 0.25). Most ISRs were mild/moderate and resolved within 2 weeks. Procedural pain was minimal, and no serious AEs were reported.
CONCLUSION


VYC-20L for cheek augmentation was safe and effective using a cannula and noninferior to needle injection.",2021,VYC-20L for cheek augmentation was safe and effective using a cannula and noninferior to needle injection.,['enrolled adults with moderate to severe Mid-Face Volume Deficit Scale (MFVDS) scores'],"['VYC-20L ', 'Hyaluronic Acid Filler, VYC-20L, via Cannula for Cheek Augmentation', 'VYC-20L', 'mL hyaluronic acid gel with lidocaine']","['MFVDS score change', 'Injection-site responses (ISRs), procedural pain, and AEs', 'Procedural pain', 'mean change in MFVDS score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0007966', 'cui_str': 'Cheek structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.198222,VYC-20L for cheek augmentation was safe and effective using a cannula and noninferior to needle injection.,"[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California; Art of Skin MD, Solana Beach, California; Aesthetic Solutions, Chapel Hill, North Carolina; Peloton Advantage, LLC, Parsippany, New Jersey; Allergan Aesthetics, an AbbVie Company, Aesthetic Medicine, Irvine, California; Clinical Development, Irvine, California.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Palm', 'Affiliation': ''}, {'ForeName': 'Sue Ellen', 'Initials': 'SE', 'LastName': 'Cox', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McDermott', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sartor', 'Affiliation': ''}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000003246']
2777,34743112,"High-Frequency, Low-Dose Education to Improve Neonatal Outcomes in Low-Resource Settings: A Cluster Randomized Controlled Trial.","BACKGROUND


Annually 2.5 million infants die in the first 28 days of life, with a significant regional distribution disparity. An estimated 80% of those could be saved if neonatal resuscitation were correctly and promptly initiated. A barrier to achieving the target is the knowledge and skills of healthcare workers.
PURPOSE


The objective of this cluster randomized trial was to assess the improvement and retention of resuscitation skills of nurses, midwives, and birth attendants in 2 birth centers serving 60 villages in rural India using high-frequency, low-dose training.
RESULTS


There was a significant difference (P < .05) between the groups in the rate of resuscitation, with 18% needing resuscitation in the control group and 6% in the intervention group. The posttest scores for knowledge retention at the final 8-month evaluation were significantly better in the intervention group than in the control group (intervention group mean rank 19.4 vs control group mean rank 10.3; P < .05). The success rate of resuscitation was not significantly different among the groups.
IMPLICATIONS FOR PRACTICE


Improved knowledge retention at 8 months and the lower need for resuscitation in the intervention group support the efficacy of the high-frequency, low-dose education model of teaching in this setting.
IMPLICATIONS FOR RESEARCH


Replication of these findings in other settings with a larger population cohort is needed to study the impact of such intervention on birth outcomes in low-resource settings.",2021,"There was a significant difference (P < .05) between the groups in the rate of resuscitation, with 18% needing resuscitation in the control group and 6% in the intervention group.","['nurses, midwives, and birth attendants in 2 birth centers serving 60 villages in rural India using high-frequency, low-dose training', 'Low-Resource Settings']",[],"['success rate of resuscitation', 'knowledge retention']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0085142', 'cui_str': 'Birth Centers'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",[],"[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0209999,"There was a significant difference (P < .05) between the groups in the rate of resuscitation, with 18% needing resuscitation in the control group and 6% in the intervention group.","[{'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Spies', 'Affiliation': 'Louise Herrington School of Nursing, Baylor University, Dallas, Texas (Drs Spies and Riley); NICE Foundation, Shantinagar, Hyderabad, Telangana, India (Ms Nair and Dr Reddy); and University of Connecticut School of Medicine and University of Connecticut Health Center, Farmington (Dr Hussain).'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Riley', 'Affiliation': ''}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': ''}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Hussain', 'Affiliation': ''}, {'ForeName': 'M Padmanabh', 'Initials': 'MP', 'LastName': 'Reddy', 'Affiliation': ''}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000938']
2778,34742935,Outcomes of a Mindfulness-Based Healthy Lifestyle Intervention for Adolescents and Young Adults with Polycystic Ovary Syndrome.,"STUDY OBJECTIVE


The purpose of this study was to examine feasibility, acceptability, and preliminary efficacy of a mindfulness-based healthy lifestyle self-management intervention with adolescents and young adults diagnosed with polycystic ovary syndrome (PCOS).
DESIGN


A pilot randomized controlled trial using a pre-post design was used.
SETTING


Central Texas.
PARTICIPANTS


Individuals aged 14-23 with a diagnosis of PCOS.
INTERVENTIONS


The PCOS Kind Mind Program integrates a manualized mindfulness training program (Taming the Adolescent Mind) with health education in four key areas of self-management and health promotion; (1) medication adherence, (2) nutrition, (3) physical activity, and (4) sleep.
MAIN OUTCOME MEASURES


Psychological distress, mindfulness, physical activity strategies, nutrition and exercise self-efficacy.
RESULTS


Linear regression models revealed that those in the PCOS Kind Mind condition reported significantly higher nutrition self-efficacy (β = 6.50, 95% CI = 1.71 - 11.28, p = 0.013, d = 0.48), physical activity strategies (β = 0.41, 95% CI = 0.04 - 0.79, p = 0.040, d = 0.67), and physical activity self-efficacy (β = 0.48, 95% CI = 0.07 - 0.88, p = 0.028, d = 0.46).
CONCLUSION


The PCOS Kind Mind Program improved self-efficacy in the key areas of nutrition and physical activity and increased physical activity strategies in adolescents and young people with PCOS. These findings are encouraging and suggest the need for larger scale, randomized controlled trials with longer-term follow-up in order to more robustly evaluate the PCOS Kind Mind Program on the psychological and physiological health of adolescents and young people with PCOS.",2021,The PCOS Kind Mind Program improved self-efficacy in the key areas of nutrition and physical activity and increased physical activity strategies in adolescents and young people with PCOS.,"['Central Texas', 'adolescents and young adults diagnosed with polycystic ovary syndrome (PCOS', 'Individuals aged 14-23 with a diagnosis of PCOS', 'Adolescents and Young Adults with Polycystic Ovary Syndrome', 'adolescents and young people with PCOS']","['mindfulness-based healthy lifestyle self-management intervention', 'Mindfulness-Based Healthy Lifestyle Intervention']","['self-efficacy', 'physical activity self-efficacy', 'nutrition self-efficacy', 'physical activity strategies', 'Psychological distress, mindfulness, physical activity strategies, nutrition and exercise self-efficacy']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0182112,The PCOS Kind Mind Program improved self-efficacy in the key areas of nutrition and physical activity and increased physical activity strategies in adolescents and young people with PCOS.,"[{'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Young', 'Affiliation': 'University of Texas at Austin, School of Nursing, 1710 Red River St., Austin, TX 78712, USA. Electronic address: cyoung@mail.nur.utexas.edu.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Monge', 'Affiliation': 'The University of Texas at Austin, Dell Medical School, 1501 Red River St. Austin, TX 78712, USA.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Minami', 'Affiliation': 'Fordham University, 441 E. Fordham Road, Bronx, NY 10458, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rew', 'Affiliation': 'University of Texas at Austin, School of Nursing, 1710 Red River St., Austin, TX 78712, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Conroy', 'Affiliation': 'PhD student, University of Houston,3695 Cullen Boulevard, Houston, Texas 77204, USA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Peretz', 'Affiliation': 'University of Texas at Austin, Steve Hicks School of Social Work, 1925 San Jacinto Blvd, Austin, TX 78712, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Lucy Tan Psychological Services, Highpoint Plana 240 Waterworks Rd., Ashgrove, Qld 4060, Australia.'}]",Journal of pediatric and adolescent gynecology,['10.1016/j.jpag.2021.10.016']
2779,34743361,"Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes.","BACKGROUND


A significant improvement in clinical signs was demonstrated with abrocitinib relative to placebo in adolescents with moderate-to-severe atopic dermatitis (AD) in three phase 3, randomized, double-blinded, placebo-controlled studies (JADE TEEN [ClinicalTrials.gov, NCT03796676], JADE MONO-1 [NCT03349060] and JADE MONO-2 [NCT03575871]).
OBJECTIVES


To evaluate the impact of abrocitinib on patient-reported signs/symptoms, including sleep loss and quality of life among adolescents with moderate-to-severe AD.
METHODS


JADE TEEN, JADE MONO-1 and JADE MONO-2 were conducted in the Asia-Pacific region, Europe and North America and included patients aged 12 to 17 years with moderate-to-severe AD and inadequate response to ≥4 consecutive weeks of topical medication or treatment with systemic therapy for AD. Patients were randomly assigned (1:1:1, JADE TEEN; 2:2:1, JADE MONO-1/-2) to receive once-daily oral abrocitinib (200 mg or 100 mg) or placebo for 12 weeks in combination with topical therapy (JADE TEEN) or as monotherapy (JADE MONO-1/-2). Data from adolescent patients in JADE MONO-1/-2 were pooled for these analyses.
RESULTS


At week 12, more adolescents treated with abrocitinib (200 mg or 100 mg) vs. placebo achieved a ≥4-point improvement from baseline in the Patient-Oriented Eczema Measure in JADE TEEN (83.9% and 77.0% vs. 60.2%) and JADE MONO-1/-2 (83.0% and 69.4% vs. 43.5%) and a ≥6-point improvement from baseline in the Children's Dermatology Life Quality Index in JADE TEEN (73.8% and 67.5% vs. 56.5%) and JADE MONO-1/-2 (70.0% and 57.1% vs. 19.0%). Significant improvements in SCORing Atopic Dermatitis Visual Analog Scale for sleep loss scores were demonstrated with abrocitinib vs. placebo at weeks 2 to 12 in JADE TEEN and JADE MONO-1/-2.
CONCLUSIONS


Patient-reported signs/symptoms, including reduction of sleep loss and quality of life, were substantially improved with abrocitinib monotherapy or combination therapy relative to placebo in adolescents with moderate-to-severe AD.",2021,"Significant improvements in SCORing Atopic Dermatitis Visual Analog Scale for sleep loss scores were demonstrated with abrocitinib vs. placebo at weeks 2 to 12 in JADE TEEN and JADE MONO-1/-2.
","['adolescents with moderate-to-severe AD', 'adolescents with moderate-to-severe atopic dermatitis', 'Asia-Pacific region, Europe and North America and included patients aged 12 to 17 years with moderate-to-severe AD and inadequate response to ≥4 consecutive weeks of topical medication or treatment with systemic therapy for AD', 'adolescents with moderate-to-severe atopic dermatitis (AD']","['abrocitinib', 'placebo', 'oral abrocitinib', 'topical therapy (JADE TEEN) or as monotherapy (JADE MONO-1/-2']","['signs, symptoms and quality of life', 'SCORing Atopic Dermatitis Visual Analog Scale for sleep loss scores', 'sleep loss and quality of life']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0235161', 'cui_str': 'Sleep loss'}]",,0.591585,"Significant improvements in SCORing Atopic Dermatitis Visual Analog Scale for sleep loss scores were demonstrated with abrocitinib vs. placebo at weeks 2 to 12 in JADE TEEN and JADE MONO-1/-2.
","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'McMichael', 'Affiliation': 'Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Teng', 'Affiliation': 'Department of Dermatology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Valdez', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rojo', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Myers', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'DiBonaventura', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.17792']
2780,34760799,Plaque Removal Efficacy of Triple-Headed Toothbrush in 4-6-Year-Old Children: A Randomized Crossover Study.,"Objectives


The objective of this randomized crossover designed study was to compare the efficacy of plaque removal between a triple-headed toothbrush and a conventional single-headed toothbrush in 4-6-year-old children.
Materials and Methods


A total of 73 children, aged 4-6 years, were randomly divided into two groups (triple-headed toothbrush and conventional single-headed toothbrush). The children were instructed on how to use the toothbrush by watching a video clip for each toothbrush type and then brushed their teeth for 2 min. The remained plaque was recorded by Greene and Vermillion plaque index (PI). After a 3-week washout period, the toothbrush type was switched, the children brushed their teeth with the alternate toothbrush, and the PI scores were re-recorded.
Results


Plaque scores in the triple-headed toothbrush group were statistically significantly lower than those in the single-headed group in almost all (10 out or 12) surfaces measured ( P  < 0.05). Plaque scores were not significantly different on the buccal surfaces of the upper posterior teeth.
Conclusion


The triple-headed toothbrush showed better efficacy in plaque removal and could potentially be a good alternative to the conventional single-headed toothbrush in young children with limited hand skill.",2021,The triple-headed toothbrush showed better efficacy in plaque removal and could potentially be a good alternative to the conventional single-headed toothbrush in young children with limited hand skill.,"['4-6-year-old children', '4-6-Year-Old Children', '73 children, aged 4-6 years']","['triple-headed toothbrush and conventional single-headed toothbrush', 'triple-headed toothbrush and a conventional single-headed toothbrush', 'Triple-Headed Toothbrush']","['Plaque Removal Efficacy', 'Plaque scores', 'Greene and Vermillion plaque index (PI']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",73.0,0.0372652,The triple-headed toothbrush showed better efficacy in plaque removal and could potentially be a good alternative to the conventional single-headed toothbrush in young children with limited hand skill.,"[{'ForeName': 'Kwanchanok', 'Initials': 'K', 'LastName': 'Youcharoen', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Faculty of Dentistry, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Narawit', 'Initials': 'N', 'LastName': 'Thomngam', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Faculty of Dentistry, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Natchanok', 'Initials': 'N', 'LastName': 'Aranya', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Faculty of Dentistry, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Yasumin', 'Initials': 'Y', 'LastName': 'Wongphanthuset', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Faculty of Dentistry, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Mintita', 'Initials': 'M', 'LastName': 'Rungruangpattana', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Faculty of Dentistry, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Nathawut', 'Initials': 'N', 'LastName': 'Kaewsutha', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Faculty of Dentistry, Srinakharinwirot University, Bangkok, Thailand.'}]",Journal of International Society of Preventive & Community Dentistry,['10.4103/jispcd.JISPCD_93_21']
2781,34760801,"Evaluation of IL-1α and IL-1β, COX-2, and iNOS mRNA Expression in Orthodontic Patients Given Chitosan Mouthwash During Treatment with Miniscrew.","Objective


Chitosan is a biomaterial with antibacterial properties that may benefit from maintaining peri-miniscrew hygiene and preventing inflammation. This study aimed to evaluate the expression of inflammatory-related molecules from the gingival crevicular fluid (GCF) after treatment of 1% chitosan when compared with 0.2% chlorhexidine mouthwash of patients with orthodontic miniscrew.
Materials and Methods


A total of 30 subjects were divided into three groups: the first group received mouthwash containing 1% chitosan, the second group 0.2% chlorhexidine digluconate, and the control group received aquadest. The GCF was collected before and after 4 days of rinsing, and relative expressions of IL-1α and IL-1β, cyclooxygenase-2 (COX-2), and inducible nitric oxide synthase (iNOS) were evaluated by real-time qPCR.
Results


The expression of IL-1α was the highest in chitosan-treated patients when compared with that of IL-1β in between-groups. Patients receiving chlorhexidine have the highest expression of COX-2 and iNOS when compared with the chitosan and control groups, respectively.
Conclusion


A mouthwash containing 1% of chitosan could suppress the expression of inflammatory mediators IL-1β, COX-2, and iNOS.",2021,"A mouthwash containing 1% of chitosan could suppress the expression of inflammatory mediators IL-1β, COX-2, and iNOS.","['30 subjects', 'patients with orthodontic miniscrew', 'Orthodontic Patients Given Chitosan Mouthwash During Treatment with Miniscrew']","['chlorhexidine', 'mouthwash containing 1% chitosan, the second group 0.2% chlorhexidine digluconate, and the control group received aquadest']","['expression of IL-1α', 'expression of inflammatory mediators IL-1β, COX-2, and iNOS', 'highest expression of COX-2 and iNOS', 'relative expressions of IL-1α and IL-1β, cyclooxygenase-2 (COX-2), and inducible nitric oxide synthase (iNOS', 'IL-1α and IL-1β, COX-2, and iNOS mRNA Expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0387583', 'cui_str': 'Cyclooxygenase 2'}, {'cui': 'C0669372', 'cui_str': 'NOS2A protein, human'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]",30.0,0.0654553,"A mouthwash containing 1% of chitosan could suppress the expression of inflammatory mediators IL-1β, COX-2, and iNOS.","[{'ForeName': 'Haru Setyo', 'Initials': 'HS', 'LastName': 'Anggani', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Erlina', 'Initials': 'E', 'LastName': 'Hasriati', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Endang', 'Initials': 'E', 'LastName': 'Winiati Bachtiar', 'Affiliation': 'Department of Oral Biology and Oral Science Research Center, Faculty of Dentistry, Universitas Indonesia, Jakarta, Indonesia.'}]",Journal of International Society of Preventive & Community Dentistry,['10.4103/jispcd.JISPCD_163_21']
2782,34760767,Effect of peer support on breastfeeding self-efficacy in ilamian primiparous women: A single-blind randomized clinical trial.,"Introduction


Mother's belief, ability, and self-confidence, which is interpreted as breastfeeding self-efficacy, play a key role in the initiation and continuation of breastfeeding. Numerous factors affect this ability of the mother. Therefore, this study aimed to investigate the effect of peer support on breastfeeding self-efficacy in primiparous women.
Materials and Methods


In this clinical trial, 240 primiparous women were randomly divided into experimental and control groups. The control group program included routine training, and the experimental group received counseling and training by 30 peers during the first three months after delivery. To determine breastfeeding self-efficacy, Denis's long-term breastfeeding self-efficacy questionnaire was used at the end of week 12 after delivery. Data were analyzed using SPSS software program, version 16.0 and independent t test, Chi-square test, and Mann-Whitney U test.
Results


The mean of breastfeeding self-efficacy score at the end of week 12 after delivery was 141.11 ± 93.4 in the experimental group versus 114.40 ± 60.16 in the control group. Then, the two groups had a statistically significant difference ( P  = 0.001). Also, exclusive breastfeeding in the experimental group was higher than in the control group ( P  = 0.001).
Conclusion


Peer support for primiparous women can effectively improve breastfeeding self-efficacy and continuity of exclusive breastfeeding.",2021,"Also, exclusive breastfeeding in the experimental group was higher than in the control group ( P  = 0.001).
","['ilamian primiparous women', 'primiparous women', '240 primiparous women']","['peer support', 'routine training, and the experimental group received counseling and training']","['breastfeeding self-efficacy', 'breastfeeding self-efficacy and continuity of exclusive breastfeeding', 'mean of breastfeeding self-efficacy score', ""breastfeeding self-efficacy, Denis's long-term breastfeeding self-efficacy questionnaire""]","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332319', 'cui_str': 'Denied'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",240.0,0.0147736,"Also, exclusive breastfeeding in the experimental group was higher than in the control group ( P  = 0.001).
","[{'ForeName': 'Razhan', 'Initials': 'R', 'LastName': 'Chehreh', 'Affiliation': 'Assistant Professor, PhD of Reproductive Health, School of Midwifery and Nursing, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Shahnaz Tork', 'Initials': 'ST', 'LastName': 'Zahrani', 'Affiliation': 'Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zolaykha', 'Initials': 'Z', 'LastName': 'Karamelahi', 'Affiliation': 'MSc in Midwifery, School of Nursing and Midwifery, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Alerza Akbarzadeh', 'Initials': 'AA', 'LastName': 'Baghban', 'Affiliation': 'Professor of Biostatistics, Department of Biostatistics, School of Allied Medical Sciences, Proteomics Research Center, Shahid Beheshti University of Medical Sciences,Tehran, Iran.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_172_21']
2783,34760749,Comparison of the effect of fluoride gel and two toothpastes with different materials on remineralization of initial carious lesions in primary teeth.,"Introduction


Various types of toothpastes are claimed to be able to improve initial enamel caries. This study compared the effect of fluoride gel and two toothpastes on remineralization of initial caries lesions in primary teeth.
Materials and Methods


A total of sixty-four sound extracted primary canine were immersed in demineralizing solution at 37°C for 96 h to produce artificial caries  in vitro . Enamel pieces (3 × 3 × 5 mm) were prepared from each tooth and mounted in self cure acrylic blocks. The specimens were randomly assigned to four groups ( n  = 16) based on treatment agent (fluoride gel, Chitodent toothpaste, ReminPro toothpaste, no treatment as control) and underwent a pH cycling model for 10 days. Vickers microhardness (VH) was measured before and after treatment. Data was analyzed using analysis of variance and paired  t -test by SPSS 18 ( P  < 0.05).
Results


No significant difference was found in VH between groups at baseline (fluoride group: 265.9 ± 44.8, Chitodent group: 282.6 ± 34.6, ReminPro group: 266.5 ± 26.6, control: 272.7 ± 32.5;  P  = 0.516). Microhardness significantly increased after exposure to ReminPro toothpaste (VH change: 24.1%,  P  < 0.001) and fluoride gel (VH change: 10.9%,  P  = 0.046), but no significant changes were observed in Chitodent (VH change: 2.8%,  P  = 0.635) and control (VH change: - 2.2%,  P  = 0.181) groups.
Conclusion


ReminPro toothpaste might be effective in remineralizing initial carious lesions of primary teeth.",2021,"Microhardness significantly increased after exposure to ReminPro toothpaste (VH change: 24.1%,  P  < 0.001) and fluoride gel (VH change: 10.9%,  P  = 0.046), but no significant changes were observed in Chitodent (VH change: 2.8%,  P  = 0.635) and control (VH change: - 2.2%,  P  = 0.181) groups.
","['initial carious lesions in primary teeth', 'A total of sixty-four sound extracted primary canine', 'initial caries lesions in primary teeth']","['fluoride gel and two toothpastes', 'ReminPro toothpaste', 'treatment agent (fluoride gel, Chitodent toothpaste, ReminPro toothpaste, no treatment as control) and underwent a pH cycling model']","['VH', 'fluoride gel', 'Vickers microhardness (VH']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0266858', 'cui_str': 'Incipient enamel caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C3881208', 'cui_str': 'Fluoride gel'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C3881208', 'cui_str': 'Fluoride gel'}]",64.0,0.0446032,"Microhardness significantly increased after exposure to ReminPro toothpaste (VH change: 24.1%,  P  < 0.001) and fluoride gel (VH change: 10.9%,  P  = 0.046), but no significant changes were observed in Chitodent (VH change: 2.8%,  P  = 0.635) and control (VH change: - 2.2%,  P  = 0.181) groups.
","[{'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Meshki', 'Affiliation': 'Department of Pedodontics, Dental School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Basir', 'Affiliation': 'Department of Pedodontics, Dental School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Nadereh', 'Initials': 'N', 'LastName': 'Rahbar', 'Affiliation': 'Department of Nanotechnology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kazempour', 'Affiliation': 'Department of Pedodontics, Dental School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_1046_21']
2784,34761037,The effectiveness of lifestyle training program promoting adolescent health with polycystic ovarian syndrome: A study protocol for a randomized controlled study.,"BACKGROUND


Lifestyle training is of a key important in adolescent age for better life in the future. Healthy lifestyle in adolescents can management of any disease such as diabetes and polycystic ovarian syndrome (PCOS). Schools can provide an important environment to identify and change the lifestyle of students. The aim of this protocol is designing and evaluating the effectiveness of school-based lifestyle training program improving the PCOS of adolescents.
MATERIALS AND METHODS


A cluster-randomized controlled trial will be conducted to examine the effectiveness of school-based lifestyle training program in 16 to 18 years old adolescent girls. The healthy lifestyle program will be designed by modification of behavioral habit, dietary intake, and physical activity and educated in eight sessions for adolescents and one session for parents in the intervention groups with sixty participants.
RESULTS


Changes in primary and secondary outcomes in PCOS and healthy adolescents before and after intervention in the intervention and control groups will be analyzed for evaluation effectiveness by one-way ANOVA or other nonparametric equivalents.
CONCLUSION


The current study will provide information on the effectiveness of school-based lifestyle training programs for adolescents. With increasing numbers of PCOS at risk for long-term and/or late effects of treatment and other chronic diseases, efforts for promoting the healthy lifestyle of this important group are urgently needed. This lifestyle program may provide valuable information relating to the development of other healthy lifestyle interventions for PCOS and result in appropriate behavior change and self-management strategies.",2021,"The aim of this protocol is designing and evaluating the effectiveness of school-based lifestyle training program improving the PCOS of adolescents.
","['adolescent health with polycystic ovarian syndrome', 'adolescents', '16 to 18 years old adolescent girls', 'adolescents and one session for parents in the intervention groups with sixty participants']","['school-based lifestyle training programs', 'Lifestyle training', 'school-based lifestyle training program', 'lifestyle training program']",['PCOS and healthy adolescents'],"[{'cui': 'C1456722', 'cui_str': 'Teen Health'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}]",60.0,0.00388752,"The aim of this protocol is designing and evaluating the effectiveness of school-based lifestyle training program improving the PCOS of adolescents.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nahidi', 'Affiliation': 'Department of Midwifery and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fahimeh Ramezani', 'Initials': 'FR', 'LastName': 'Tehrani', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Delaram', 'Initials': 'D', 'LastName': 'Ghodsi', 'Affiliation': 'Department of Nutrition Research, National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Jafari', 'Affiliation': 'Department of Clinical Psychology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid Alavi', 'Initials': 'HA', 'LastName': 'Majd', 'Affiliation': 'Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Abdolahian', 'Affiliation': 'Department of Midwifery and Reproductive Health, Student Research Committee, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_15_21']
2785,34761035,Effects of blended aromatherapy using lavender and damask rose oils on the test anxiety of nursing students.,"BACKGROUND


People experience extreme anxiety in testing situations, so it considers as a psychological condition and can actually impair learning and hurt test performance. People experience some degree of stress and anxiety before and during examinations. This study aimed to investigate the effect of blended aromatherapy using lavender and damask rose oils on the test anxiety of nursing students.
MATERIALS AND METHODS


The present study was a single-blinded clinical trial study. Seventy nursing students were selected and randomly assigned to two experimental and sham groups. For the experimental group, seven droplets of lavender, 10%, and three droplets of damask rose oil, 10%, and for the sham group, ten droplets of sesame oil were poured on a nonabsorbent pad which was placed within a 20-cm distance from the students' noses on their chairs' handles. The data were collected by using a two-part questionnaire including demographic information and State-Trait Anxiety Inventory 1, before, 15 min after the intervention, and immediately at the end of the test. Data were analyzed using descriptive (frequency, mean, and standard deviation) and inferential (independent  t -test, ANOVA with repeated measure, Fisher's exact test, and least significant difference  post hoc  test) statistics.
RESULTS


It was found that no significant difference between the two groups in terms of age, the number of credits, Semester Grade Point Average and, gender, place of residence and marital status and the two groups were almost identical in regard of the above variables ( P  > 0.05). State anxiety mean scores of the experimental group were lower than the mean scores of the sham group, 15 min after the intervention and at the end of the test, and the difference between the groups was statistically significant ( P  < 0.05).
CONCLUSIONS


Blended aromatherapy is effective in improving the test anxiety of nursing students. Therefore, it can be used as a therapeutic approach to reduce test anxiety.",2021,"State anxiety mean scores of the experimental group were lower than the mean scores of the sham group, 15 min after the intervention and at the end of the test, and the difference between the groups was statistically significant ( P  < 0.05).
","['nursing students', 'Seventy nursing students']","['Blended aromatherapy', 'blended aromatherapy using lavender and damask rose oils']","['State anxiety mean scores', 'number of credits, Semester Grade Point Average and, gender, place of residence and marital status']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0304113', 'cui_str': 'Rose oil'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}]",70.0,0.0670572,"State anxiety mean scores of the experimental group were lower than the mean scores of the sham group, 15 min after the intervention and at the end of the test, and the difference between the groups was statistically significant ( P  < 0.05).
","[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Hashemi', 'Affiliation': 'Department of Adult Health, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nazari', 'Affiliation': 'Isfahan Neurosciences Research Center, Department of Adult Health, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Aref', 'Initials': 'A', 'LastName': 'Faghih', 'Affiliation': 'Department of Crisis Management, Faculty Faculty of Literature and Humanities, Islamic Azad University, Kerman, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Forughi', 'Affiliation': 'Department of Crisis Management, Faculty Faculty of Literature and Humanities, Islamic Azad University, Kerman, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_88_21']
2786,34761031,The effect of peer support on quality of life among type 2 diabetic patients in deprived areas in Iran: A randomized clinical trial.,"BACKGROUND


Quality of life (QOL) is one of the effective factors in promoting the health of diabetic patients. In recent years, the role of peer support in the optimal management of diabetes has gained increasing attention. However, contradictory results have been reported from the effectiveness of this method. This study aimed to investigate the effect of peer support on the QOL among type 2 diabetic patients in deprived areas.
MATERIALS AND METHODS


This study was a randomized clinical trial conducted on 80 patients with T2D referring to the diabetes Clinic in Aligoudarz in Iran. Participants were randomly assigned into two groups of 40 patients. Intervention group received a peer Supportive-educational program for 3 months and the control group received routine clinic care. Diabetes QOL brief clinical inventory was used to collect the data. This questionnaire was completed three times at the beginning of the study, immediately after the 3-day training, and after 3 months of peer supportive intervention. The SPSS software (v. 18.0) was used to analyze the data through the Generalized Estimating Equations.
RESULTS


There was no significant difference in mean QOL between the two groups before the intervention ( P  = 0.891) and immediately after the education ( P  = 0.076). However, after 3 months of intervention, the intervention group showed a significant improvement in mean QOL compared to those in the control group ( P  < 0.001).
CONCLUSION


Peer support program can improve the QOL in type 2 diabetic patients in deprived areas. Therefore, this method can be recommended to improve care and educational programs in these patients.",2021,There was no significant difference in mean QOL between the two groups before the intervention ( P  = 0.891) and immediately after the education ( P  = 0.076).,"['type 2 diabetic patients in deprived areas', 'type 2 diabetic patients in deprived areas in Iran', 'diabetic patients', '80 patients with T2D referring to the diabetes Clinic in Aligoudarz in Iran']","['peer support', 'Peer support program', 'peer Supportive-educational program for 3 months and the control group received routine clinic care']","['QOL', 'quality of life', 'mean QOL']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",80.0,0.00870325,There was no significant difference in mean QOL between the two groups before the intervention ( P  = 0.891) and immediately after the education ( P  = 0.076).,"[{'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Shahsavari', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Estebsari', 'Affiliation': 'Department of Community Health Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Foroozan', 'Initials': 'F', 'LastName': 'Atashzadeh-Shoorideh', 'Affiliation': 'Department of Psychiatric Nursing and Management, School of Nursing and Midwifery, Shahid Labbafinezhad Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Ilkhani', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_72_21']
2787,34761021,Comparing the effect of face-to-face education and using educational films on couples' sexual dysfunction during pregnancy.,"BACKGROUND


Pregnancy is a special period in a woman's life during which physical, mental, social, and cultural changes would affect sexual desires during this period. The present study was conducted to compare the effect of face-to-face education and using educational films on the sexual dysfunction in couples.
MATERIALS AND METHODS


The present study was a semi-experimental research. Study population contained pregnant women and their husbands. Samples were selected randomly. Data were gathered using demographic characteristic questionnaire and sexual dysfunction in men and women questionnaire. Sample size was 96 couples (32 couples in the face-to-face group, 32 in the educational films group, and 32 in the control group). Data were analyzed using SPSS20 software.
RESULTS


The mean total score of preintervention sexual function in face-to-face education group was 46.72 ± 9.79, in educational film group 47.82 ± 13.07, and in control group 43.84 ± 12.76. In the case of postintervention, it was, respectively, 60.62 ± 9.72, 57.37 ± 14.74, and 43.61 ± 14.21. Face-to-face education led to the treatment of sexual dysfunction during pregnancy ( P  < 0.001). In the educational film group ( P  = 0.40), sexual dysfunction during pregnancy was not treated, but there was an improvement in sexual function ( P  = 0.001). In the control group, there was a significant difference regarding the decrease in the score of sexual function and untreated sexual dysfunction during pregnancy ( P  = 0.001). Furthermore, no improvement was observed in the sexual dysfunction during pregnancy ( P  = 0.90).
CONCLUSIONS


According to the results, face-to-face and film education are effective in sexual function during pregnancy, but face-to-face education in pregnancy is more effective in the treatment of sexual dysfunction, and so this causes promoting sexual health during this period.",2021,Face-to-face education led to the treatment of sexual dysfunction during pregnancy ( P  < 0.001).,"['couples', ""couples' sexual dysfunction during pregnancy"", 'Study population contained pregnant women and their husbands', '96 couples (32 couples in the face-to-face group, 32 in the educational films group, and 32 in the control group']",['face-to-face education and using educational films'],"['sexual dysfunction', 'score of sexual function and untreated sexual dysfunction', 'sexual function', 'mean total score of preintervention sexual function']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242664', 'cui_str': 'Husband'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",96.0,0.0058249,Face-to-face education led to the treatment of sexual dysfunction during pregnancy ( P  < 0.001).,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Research Centre for Nursing and Midwifery Care, Faculty of Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'MohammadBagher', 'Initials': 'M', 'LastName': 'Khani', 'Affiliation': 'Research Centre for Nursing and Midwifery Care, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_1535_20']
2788,34761258,Effectiveness of theory-based Multimedia Messaging Service (MMS) on exercise benefits and barriers among patients with type 2 diabetes.,"The current study aimed to examine the effectiveness of multimedia messaging service (MMS) education on exercise benefits and barriers in patients with type 2 diabetes. A quasi-experimental, pretest-post-test design recruited 98 patients with type 2 diabetes. The intervention group received MMS education to improve perceived exercise benefits and decrease exercise barriers over two months, and the control group received routine care. All patients completed a survey at three time points (baseline, 4 and 8 weeks post-intervention). The results showed that there was an improvement in both perceived life enhancement and physical performance domains in the intervention group. The exercise context barriers decreased after the first follow-up but increased during the second follow-up in the intervention group. Cohen's d values indicated a medium effect size in life enhancement (0.502) and physical performance (0.525) subscales. A small effect size was found in psychological outlook (0.196) and exercise context (0.132) subscales. However, there was no significant effect of the intervention in time expenditure (-0.244) and physical exertion (-0.119) subscales. In conclusion, theoretically based MMS health education targeting perceived exercise benefits and barriers was feasible and cost-effective in changing patients with diabetes' perceptions and intended behaviors about regular physical activity.",2021,The exercise context barriers decreased after the first follow-up but increased during the second follow-up in the intervention group.,"['98 patients with type 2 diabetes', 'patients with type 2 diabetes']","['MMS education to improve perceived exercise benefits and decrease exercise barriers over two months, and the control group received routine care', 'multimedia messaging service (MMS) education', 'theory-based Multimedia Messaging Service (MMS']","['medium effect size in life enhancement (0.502) and physical performance (0.525) subscales', 'time expenditure (-0.244) and physical exertion (-0.119) subscales', 'life enhancement and physical performance domains', 'psychological outlook']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C4517442', 'cui_str': '0.244'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",98.0,0.0154305,The exercise context barriers decreased after the first follow-up but increased during the second follow-up in the intervention group.,"[{'ForeName': 'Nihaya A', 'Initials': 'NA', 'LastName': 'Al-Sheyab', 'Affiliation': 'Department of Allied Medical Sciences, Jordan University of Science and Technology, PO Box (3030), Irbid 22110, Jordan.'}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Alyahya', 'Affiliation': 'Department of Health Management and Policy, Jordan University of Science and Technology, PO Box (3030), Irbid 22110, Jordan.'}, {'ForeName': 'Jumana A', 'Initials': 'JA', 'LastName': 'Alqudah', 'Affiliation': 'Public Health and Community Medicine, Jordan University of Science and Technology, PO Box (3030), Irbid 22110, Jordan.'}]",Health education research,['10.1093/her/cyab038']
2789,34761243,"Mindfulness meditation training effects on quality of life, immune function and glutathione metabolism in service healthy female teachers: A randomized pilot clinical trial.","Background


Despite the crucial role of educators in encourage students' academic learning, addressing educator stress inside the classroom remains a significant challenge in the educational context. Mindfulness Meditation training (MM) has been recommended as an environmental enrichment strategy in schools to help teachers cope with stress and cultivating a state of awareness in daily life. Although studies have shown that MM can improve immune system dynamics the biological mechanism underlying glutathione metabolism in a healthy human is unclear.
Objective


The purpose of this study was to determine whether MM training benefits psychological and behavioral response, immunological functions and glutathione metabolism in service healthy female teachers from public schools.
Methods


We randomly assigned 76 teachers to an 8-week Mindfulness-Based Health Program for Educators (MBHPEduca) or Neuroscience for Education program (Neuro-Educa; active control group). Using the quality of life as our primary outcome, perceived stress, negative affectivity, and resilience as our secondary outcome, and pro-inflammatory cytokines and glutathione levels as our third outcome at baseline and post-intervention that occurred in public schools. Blood samples were collected for the measurement of three proinflammatory markers, including interleukin-1β (IL-1β), interleukin-6 (IL-6), and interleukin-8 (IL-8) and three GSH metabolism, including Cysteine (Cys), Homocysteine (HCys) and GSH were conducted at pre-and post-intervention, with selfreported assessments over time. Treatment effects were analyzed using generalized estimating equations (GEE) with to intention to treat.
Results


We observed statistically significant improvements to the MBHP-Educa group compared to active control in perceived stress, resilience, positive and negative affect, and quality of life after 8-weeks MM (p ​< ​0.0001). Further, the MBHP-Educa group exhibited lower circulating IL-6 production accompanied by high circulating GSH, and Cys (p ​< ​0.0001). Additional analyses indicated that enhancing quality of life through mindfulness meditation training was mediated by reducing perceived stress and serum levels of IL- 6 and increasing resilience and teachers 'plasma GSH levels.
Conclusions


The present study is a pilot trial with low-power and provides preliminary evidence that mindfulness meditation training help teachers to cope with stress in the school environment with an impact on the quality of life, immune function, and glutathione metabolism.",2021,"We observed statistically significant improvements to the MBHP-Educa group compared to active control in perceived stress, resilience, positive and negative affect, and quality of life after 8-weeks MM (p ​< ​0.0001).","['service healthy female teachers from public schools', 'service healthy female teachers']","['Mindfulness meditation training', 'Mindfulness Meditation training (MM', '8-week Mindfulness-Based Health Program for Educators (MBHPEduca) or Neuroscience for Education program (Neuro-Educa; active control group', 'MM training', 'mindfulness meditation training']","['quality of life, immune function and glutathione metabolism', 'stress, resilience, positive and negative affect, and quality of life', 'quality of life, immune function, and glutathione metabolism', 'circulating IL-6 production', ""perceived stress and serum levels of IL- 6 and increasing resilience and teachers 'plasma GSH levels"", 'interleukin-1β (IL-1β), interleukin-6 (IL-6), and interleukin-8 (IL-8) and three GSH metabolism, including Cysteine (Cys), Homocysteine (HCys) and GSH', 'perceived stress, negative affectivity, and resilience as our secondary outcome, and pro-inflammatory cytokines and glutathione levels']","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0557800', 'cui_str': 'Public school'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}]",76.0,0.0458823,"We observed statistically significant improvements to the MBHP-Educa group compared to active control in perceived stress, resilience, positive and negative affect, and quality of life after 8-weeks MM (p ​< ​0.0001).","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rodrigues de Oliveira', 'Affiliation': 'Mente Aberta - Brazilian Center for Mindfulness and Health Promotion, Departamento de Medicina Preventiva, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Mente Aberta - Brazilian Center for Mindfulness and Health Promotion, Departamento de Medicina Preventiva, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Palace-Berl', 'Affiliation': 'Departamento de Patologia, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'de Mello Ponteciano', 'Affiliation': 'Departamento de Patologia, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Fungaro Rissatti', 'Affiliation': 'Departamento de Patologia, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'Sardela de Miranda', 'Affiliation': 'Laboratório de Imunomodulação, Departamento de Imunologia, Instituto de Ciências Biomédicas, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Valéria', 'Initials': 'V', 'LastName': 'Piassa Pollizi', 'Affiliation': 'Mente Aberta - Brazilian Center for Mindfulness and Health Promotion, Departamento de Medicina Preventiva, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Fuscella', 'Affiliation': 'Centro Educacional Objetivo, São Paulo, SP, Brazil.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mourão Terzi', 'Affiliation': 'Instituto Federal de Educação, Ciência e Tecnologia do Sudeste de Minas Gerais, Campus, São João del-Rei, MG, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Lepique', 'Affiliation': 'Laboratório de Imunomodulação, Departamento de Imunologia, Instituto de Ciências Biomédicas, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Vânia', 'Initials': 'V', 'LastName': ""D'Almeida"", 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Demarzo', 'Affiliation': 'Mente Aberta - Brazilian Center for Mindfulness and Health Promotion, Departamento de Medicina Preventiva, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]","Brain, behavior, & immunity - health",['10.1016/j.bbih.2021.100372']
2790,34761160,Estimating 24-Hour Urinary Excretion of Sodium and Potassium Is More Reliable from 24-Hour Urine Than Spot Urine Sample in a Feeding Study of US Older Postmenopausal Women.,"Background


Assessing estimated sodium (Na) and potassium (K) intakes derived from 24-h urinary excretions compared with a spot urine sample, if comparable, could reduce participant burden in epidemiologic and clinical studies.
Objectives


In a 2-week controlled-feeding study, Na and K excretions from a 24-h urine collection were compared with a first-void spot urine sample, applying established algorithms and enhanced models to estimate 24-h excretion. Actual and estimated 24-h excretions were evaluated relative to mean daily Na and K intakes in the feeding study.
Methods


A total of 153 older postmenopausal women ages 75.4 ± 3.5 y participated in a 2-wk controlled-feeding study with a 4-d repeating menu cycle based on their usual intake (ClinicalTrials.gov Identifier: NCT00000611). Of the 150 participants who provided both a first-void spot urine sample and a 24-h urine collection on the penultimate study day, statistical methods included Pearson correlations for Na and K between intake, 24-h collections, and the 24-h estimated excretions using 4 established algorithms: enhanced biomarker models by regressing ln-transformed intakes on ln-transformed 24-h excretions or ln-transformed 24-h estimated excretions plus participant characteristics and sensitivity analyses for factors potentially influencing Na or K excretion (e.g., possible kidney disease estimated glomerular filtration rate <60 mL/min/1.73 m 2  ).
Results


Pearson correlation coefficients between Na and K intakes and actual 24-h excretions were 0.57 and 0.38-0.44 for estimated 24-h excretions, depending on electrolyte and algorithm used. Enhanced biomarker model cross-validated  R   2  (CVR 2 ) for 24-h excretions were 38.5% (Na), 40.2% (K), and 42.0% (Na/K). After excluding participants with possible kidney disease, the CVR 2  values were 43.2% (Na), 40.2% (K), and 38.1% (Na/K).
Conclusions


Twenty-four-hour urine excretion measurement performs better than estimated 24-h excretion from a spot urine as a biomarker for Na and K intake among a sample of primarily White postmenopausal women.",2021,"Enhanced biomarker model cross-validated  R   2  (CVR 2 ) for 24-h excretions were 38.5% (Na), 40.2% (K), and 42.0% (Na/K).","['Older Postmenopausal Women', 'primarily White postmenopausal women', '150 participants who provided both a first-void spot urine sample', '153 older postmenopausal women ages 75.4\xa0±\xa03.5 y participated']","['\n\n\nAssessing estimated sodium (Na) and potassium (K) intakes', 'Sodium and Potassium']","['mean daily Na and K intakes', 'Na and K intakes and actual 24-h excretions', 'Enhanced biomarker model cross-validated  R   2  (CVR 2 ) for 24-h excretions']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0457208', 'cui_str': 'Spot urine sample'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}]",153.0,0.0777576,"Enhanced biomarker model cross-validated  R   2  (CVR 2 ) for 24-h excretions were 38.5% (Na), 40.2% (K), and 42.0% (Na/K).","[{'ForeName': 'Lesley F', 'Initials': 'LF', 'LastName': 'Tinker', 'Affiliation': 'Division of Public Health Sciences, Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Division of Public Health Sciences, Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Carbone', 'Affiliation': 'Department of Medicine, Medical College of Georgia at Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Snetselaar', 'Affiliation': 'Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Departments of Epidemiology, Medicine, and Surgery and Center for Global Cardiometabolic Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Mossavar-Rahmani', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Division of Public Health Sciences, Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Division of Public Health Sciences, Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzab125']
2791,34761154,External qualification of the Web-Accessible Population Pharmacokinetic Service-Hemophilia (WAPPS-Hemo) models for octocog alfa using real patient data.,"Background


Existing adult patient pharmacokinetic (PK) data from the published Advate vs Kovaltry PK crossover study were used for this validation study. This data set is appropriate for qualification, given that it has not been previously submitted to Web-Accessible Population Pharmacokinetic Service-Hemophilia (WAPPS-Hemo) and will not have impacted the WAPPS-Hemo models for Kovaltry.
Objective


To compare the population PK parameters for Kovaltry (BAY 81-8973) derived from the WAPPS-Hemo models with PK parameters derived from noncompartmental analysis (NCA), using a validation PK dataset.
Methods


The qualification data set included Kovaltry factor activity (10 samples per infusion) and anthropometric data for 18 patients. Two analyses were performed comparison of Bayesian forecasting from the WAPPS-Hemo models versus NCA using the full 10-sample data set; and comparison of Bayesian forecasting using the full versus reduced 4- and 3-sample data sets. Agreement between outcomes was assessed by quantifying the variability and bias of the error.
Results


Comparison of WAPPS-Hemo models versus NCA led to well-correlated outcomes despite a systematic overprediction of clearance. Population PK models demonstrated greater consistency with NCA on one-stage data, compared with chromogenic data. WAPPS-Hemo model results were consistent in reduced sampling compared to full sampling. Inclusion of a 48-hour time point in the reduced sampling greatly improved the consistency with full sampling.
Discussion


Qualification of population PK models and their use for Bayesian forecasting in full and reduced sampling is an essential step toward their validation. The evaluations performed in this study support the confidence of PK parameter estimates provided by the models.",2021,"This data set is appropriate for qualification, given that it has not been previously submitted to Web-Accessible Population Pharmacokinetic Service-Hemophilia (WAPPS-Hemo) and will not have impacted the WAPPS-Hemo models for Kovaltry.
",['18 patients'],"['NCA', 'WAPPS']",['Kovaltry factor activity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C4084378', 'cui_str': 'Kovaltry'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",2.0,0.0858469,"This data set is appropriate for qualification, given that it has not been previously submitted to Web-Accessible Population Pharmacokinetic Service-Hemophilia (WAPPS-Hemo) and will not have impacted the WAPPS-Hemo models for Kovaltry.
","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chelle', 'Affiliation': 'School of Pharmacy University of Waterloo Waterloo ON Canada.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Hajducek', 'Affiliation': 'School of Pharmacy University of Waterloo Waterloo ON Canada.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Mahdi', 'Affiliation': 'Bayer, Mississauga ON Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'Bayer, Mississauga ON Canada.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Iorio', 'Affiliation': 'McMaster-Bayer Endowed Research Chair for Clinical Epidemiology of Congenital Bleeding Disorders Department of Medicine Department of Health Research Methods, Evidence and Impact McMaster University ON Canada.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Silvertown', 'Affiliation': 'Bayer, Mississauga ON Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Edginton', 'Affiliation': 'School of Pharmacy University of Waterloo Waterloo ON Canada.'}]",Research and practice in thrombosis and haemostasis,['10.1002/rth2.12599']
2792,34761134,Effect of different doses of triacontanol on growth and yield of kohlrabi ( Brassica oleracea  L. var.  gongylodes ).,"Triacontanol (TRIA), an endogenous plant growth regulator, promotes various metabolic activities in plants, resulting in improved growth and development in kohlrabi. The objective of this study was to assess the effect of different doses of triacontanol on the growth and yield of kohlrabi. This study was carried out in a randomized complete block design (RCBD) with five replications at Purkot Daha, Gulmi, Nepal, from October 2020 to January 2021. The treatments consisted of four doses of triacontanol (Niraculan 0.05% EC) diluted in water  viz  0 mL L -1  (control), 1 mL L -1 , 1.5 mL L -1  and 2 mL L -1 . The results showed that triacontanol application significantly increased plant height, number of leaves, leaf length, and width of the large leaf at 40 days after transplanting (DAT). Plants treated with triacontanol at the dose of 1 mL L -1  produced the highest plant height (14.61 cm), which was statistically at par with 0 mL L -1  (12.76 cm) and 2 mL L -1  (14.26 cm). Similarly, at 40 DAT, plants treated with triacontanol at the dose of 2 mL L -1  produced the highest number of leaves (5.56), which was statistically at par with 1 mL L -1  (5.4) and 1.5 mL L -1  (4.96). Likewise, at 40 DAT, the highest length of large leaf (13.95 cm) and width of the large leaf (5.09 cm) were found in plants treated with triacontanol at the dose of 1 mL L -1 , which was statistically similar with 2 mL L -1 . The yield was found to be higher (6.75% to 40.4%) in plants treated with triacontanol as compared to plants treated with triacontanol at the dose of 0 mL L -1 . A significant difference was found in the harvest index. The highest harvest index (0.39) was found in plants treated with triacontanol at the dose of 2 mL L -1 , which was statistically similar with 1 mL L -1  (0.35) and 1.5 mL L -1  (0.39). The lowest harvest index (0.31) was found in plants treated with 0 mL -1 . This study suggests that farmers can apply triacontanol at the dose of 1 mL L -1  to enhance the growth and yield of kohlrabi.",2021,"The results showed that triacontanol application significantly increased plant height, number of leaves, leaf length, and width of the large leaf at 40 days after transplanting (DAT).",[],"['triacontanol (Niraculan 0.05% EC) diluted in water  viz  0', 'triacontanol', 'Triacontanol (TRIA']","['harvest index', 'plant height, number of leaves, leaf length, and width of the large leaf', 'highest plant height', 'highest harvest index', 'highest length of large leaf (13.95 cm) and width of the large leaf']",[],"[{'cui': 'C0044634', 'cui_str': '1-triacontanol'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0682475', 'cui_str': 'Subkingdom Tracheobionta'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0418159,"The results showed that triacontanol application significantly increased plant height, number of leaves, leaf length, and width of the large leaf at 40 days after transplanting (DAT).","[{'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Agriculture and Forestry University, Rampur, Chitwan, Nepal.'}, {'ForeName': 'Aashish', 'Initials': 'A', 'LastName': 'Bhandari', 'Affiliation': 'Agriculture and Forestry University, Rampur, Chitwan, Nepal.'}, {'ForeName': 'Jiban', 'Initials': 'J', 'LastName': 'Shrestha', 'Affiliation': 'Nepal Agricultural Research Council, National Plant Breeding and Genetics Research Centre, Khumaltar, Lalitpur, Nepal.'}]",Heliyon,['10.1016/j.heliyon.2021.e08242']
2793,34761586,Application value of Doppler ultrasound combined with CA125 and CA19.9 in the early diagnosis of epithelial ovarian cancer.,"PURPOSE


An early diagnosis is of great significance in improving the survival rate of patients. At present, the application values of different diagnostic methods in ovarian cancer are different, and the clinical diagnosis alone is not ideal. Therefore, this study explored the application value of Doppler ultrasound combined with CA125 and CA19.9 in the early diagnosis of epithelial ovarian cancer.
METHODS


A total of 58 patients with ovarian diseases were divided into an observation group (epithelial ovarian cancer group, n=29) and a control group (benign ovarian tumour group, n=29). Doppler ultrasound results and serum CA125 and CA19.9 detection results of the two groups were collected to analyse and compare the application values of ultrasound and different kinds of tumour markers in the early diagnosis of epithelial ovarian cancer.
RESULTS


The results of Doppler ultrasound showed that the resistance index of the blood flow in the observation group was lower than that in the control group, and the ultrasound score was higher than that in the control group (p<0.05). The levels of serum tumour markers CA125 and CA19.9 in the observation group were significantly higher than those in the control group (p<0.05). The results of the repeated measurement analysis of variance showed that there were significant differences in the ultrasound score, blood flow resistance index, and CA125 and CA19.9 levels in different stages of ovarian cancer (p<0.05). There was no difference in the ultrasonographic score between stage I and the partum stage, while the stages of menstruation and implantation showed a gradually increasing trend (p<0.05). The blood flow resistance index and CA125 and CA19.9 levels increased gradually with the stage (p<0.05). The sensitivity (93.1%), specificity (96.55%), positive predictive value (96.43%), negative predictive value (93.33%) and diagnosis rate (94.83%) of Doppler ultrasonography combined with CA125 and CA19.9 in the diagnosis of epithelial ovarian cancer were higher than those of the single indicator detection method or the two combined diagnostic detection methods.
CONCLUSION


Doppler ultrasound combined with CA125 and CA19.9 has high sensitivity, high specificity and high coincidence rate and can improve the early clinical diagnosis of epithelial ovarian cancer.",2021,The blood flow resistance index and CA125 and CA19.9 levels increased gradually with the stage (p<0.05).,"['epithelial ovarian cancer', '58 patients with ovarian diseases']","['Doppler ultrasound combined with CA125 and CA19.9', 'control group (benign ovarian tumour group', 'observation group (epithelial ovarian cancer']","['resistance index of the blood flow', 'specificity', 'ultrasound score', 'survival rate', 'sensitivity', 'negative predictive value', 'levels of serum tumour markers CA125 and CA19.9', 'diagnosis rate', 'epithelial ovarian cancer', 'ultrasonographic score', 'positive predictive value', 'blood flow resistance index and CA125 and CA19.9 levels', 'ultrasound score, blood flow resistance index, and CA125 and CA19.9 levels']","[{'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029928', 'cui_str': 'Disorder of ovary'}]","[{'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004997', 'cui_str': 'Benign neoplasm of ovary'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1869090', 'cui_str': 'Tumour markers (SMQ)'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",58.0,0.0992187,The blood flow resistance index and CA125 and CA19.9 levels increased gradually with the stage (p<0.05).,"[{'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Ultrasonography, Yantaishan Hospital, Yantai, China.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Shaoqin', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
2794,34761530,Information about foot care provided to people with diabetes with or without their partners: Impact on recommended foot care behavior.,"BACKGROUND


Many people with diabetes will develop foot ulcers. To reduce risk, it is recommended that the feet are protected against harm and checked daily. Spouses can help people with diabetes care for their feet.
METHODS


A randomized parallel arm design compared information sheets given to participants with diabetes and their spouses (dyad group; n = 64) to an information sheet given only to participants with diabetes (individual group; n = 69). The self-reported number of days that the participant with diabetes' feet were (1) checked for problems and (2) protected against problems occurring (by the person with diabetes and/or the spouse) were summed for the week after receiving the information sheet. ANCOVAs tested the effects of group.
RESULTS


Frequency of foot detection behavior (Participant + Spouse) was significantly higher in the dyad group compared with the individual group. This was not the case for foot protection behavior (Participant + Spouse). Findings revealed greater levels of spousal support (for both protection and detection behavior) in the dyad group compared to the individual group.
CONCLUSIONS


Clinical recommendations and advice on foot care delivered both to people with diabetes and their spouses can encourage greater foot care than if delivered to the patient alone.",2021,"RESULTS


Frequency of foot detection behavior (Participant + Spouse) was significantly higher in the dyad group compared with the individual group.","['people with diabetes with or without their partners', 'participants with diabetes and their spouses (dyad group; n\u2009=\u200964) to an information sheet given only to participants with diabetes (individual group; n\u2009=\u200969']",[],"['Frequency of foot detection behavior', 'levels of spousal support']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],"[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.0202092,"RESULTS


Frequency of foot detection behavior (Participant + Spouse) was significantly higher in the dyad group compared with the individual group.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Reaney', 'Affiliation': 'Institute of Education, Health, and Social Sciences, University of Chichester, Chichester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gladwin', 'Affiliation': 'Institute of Education, Health, and Social Sciences, University of Chichester, Chichester, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Churchill', 'Affiliation': 'Institute of Education, Health, and Social Sciences, University of Chichester, Chichester, UK.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12314']
2795,34761474,rFIXFc prophylaxis improves pain and levels of physical activity in haemophilia B: Post hoc analysis of B-LONG using haemophilia-specific quality of life questionnaires.,"INTRODUCTION


Recurrent bleeding in severe haemophilia B causes painful hemarthroses and reduces capacity for physical activity. Recombinant factor IX Fc fusion protein (rFIXFc) prophylaxis results in low annualised bleeding rates, with the potential to improve patients' health-related quality of life (HRQoL).
AIM


To present a post hoc analysis of data from B-LONG describing change over time in patient-reported outcomes associated with pain and physical activity.
METHODS


Patients (≥12 years) who received weekly dose-adjusted or interval-adjusted rFIXFc prophylaxis and completed the Haemophilia-Specific QoL questionnaire for adolescents (Haemo-QoL) or adults (Haem-A-QoL) at baseline (BL) and end of study (EoS). Individual level changes in items of the 'Physical Health' and 'Sports and Leisure' domains, categorised as 'never/rarely/seldom' or 'sometimes/often/all the time', were analysed using McNemar's test to compare distribution of responses at EoS versus BL.
RESULTS


At EoS versus BL, a significantly greater proportion of patients did not experience painful swellings (64% vs. 44%; P = .004), painful joints (44% vs. 28%; P = .003) or pain when moving (54% vs. 41%; P = .026). Additionally, at EoS versus BL, patients were less likely to avoid participating in sports like football (30% vs. 8%; P = .002), avoid sports due to their haemophilia (47% vs. 27%; P = .007), or experience difficulty walking as far as they wanted (63% vs. 43%; P = .001). The proportion of patients who played sports as much as the general population was numerically increased (52% vs. 37%; P = .033) at EoS versus BL.
CONCLUSION


Results of the analysis suggest that over time, rFIXFc prophylaxis is associated with significant improvements in pain and physical functioning. This contributes to previous evidence of overall HRQoL improvements in patients with haemophilia B treated with rFIXFc.",2021,"The proportion of patients who played sports as much as the general population was numerically increased (52% vs. 37%; P = .033) at EoS versus BL.
CONCLUSION


Results of the analysis suggest that over time, rFIXFc prophylaxis is associated with significant improvements in pain and physical functioning.","['haemophilia B', 'for adolescents (Haemo-QoL) or adults (Haem-A-QoL) at baseline (BL) and end of study (EoS', 'Patients (≥12 years) who received', 'patients with haemophilia B treated with rFIXFc']","['rFIXFc prophylaxis', 'Recombinant factor IX Fc fusion protein (rFIXFc) prophylaxis', 'weekly dose-adjusted or interval-adjusted rFIXFc prophylaxis and completed the Haemophilia-Specific QoL questionnaire']","['pain and levels of physical activity', 'pain and physical functioning', 'pain', 'painful joints', 'experience painful swellings', 'avoid sports due to their haemophilia']","[{'cui': 'C0008533', 'cui_str': 'Factor IX deficiency'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018966', 'cui_str': 'Heme'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2826076', 'cui_str': 'Nonacog alfa'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein'}]","[{'cui': 'C2826076', 'cui_str': 'Nonacog alfa'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}]",,0.056102,"The proportion of patients who played sports as much as the general population was numerically increased (52% vs. 37%; P = .033) at EoS versus BL.
CONCLUSION


Results of the analysis suggest that over time, rFIXFc prophylaxis is associated with significant improvements in pain and physical functioning.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Astermark', 'Affiliation': 'Department of Translational Medicine, Lund University, Malmö, Sweden.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Hermans', 'Affiliation': 'Division of Haematology, Haemostasis and Thrombosis Unit, Saint-Luc University Hospital, Université catholique de Louvain (UCLouvain), Brussels, Belgium.'}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Ezzalfani', 'Affiliation': 'Creativ-Ceutical, Paris, France.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Aballéa', 'Affiliation': 'Creativ-Ceutical, Rotterdam, Netherlands.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santagostino', 'Affiliation': 'Swedish Orphan Biovitrum AB, Basel, Switzerland.'}, {'ForeName': 'Zalmai', 'Initials': 'Z', 'LastName': 'Hakimi', 'Affiliation': 'Swedish Orphan Biovitrum AB, Stockholm, Sweden.'}, {'ForeName': 'Jameel', 'Initials': 'J', 'LastName': 'Nazir', 'Affiliation': 'Swedish Orphan Biovitrum AB, Stockholm, Sweden.'}]",Haemophilia : the official journal of the World Federation of Hemophilia,['10.1111/hae.14455']
2796,34761392,Effect of self-assessment in a removable prosthodontics preclinical course on skills and competence.,"PURPOSE


Self-assessment is increasingly implemented in medical professions' curricula. In this research, the authors measure the effects of self-assessment within a preclinical removable prosthodontics course among dental students in a private dental school according to the European qualifications framework descriptors.
MATERIALS AND METHODS


Thirty subjects, all fourth-year dental students, were included in this experiment. Fifteen subjects were included in each of the experimental and control groups during one semester. The experimental group subjects used the study roadmap tool in their preclinical tasks. The control group subjects executed the same preclinical tasks under instructor supervision only. All subjects were filmed, and an autonomy score was given to every subject per session. At the end of the semester, cognitive skills development was compared using the Kember et al. questionnaire while practical skills development was compared using a comparison of grades. Two focus groups were undertaken with experimental group subjects. Qualitative and quantitative data were collected and statistically analyzed (p < 0.005).
RESULTS


Subjects from the experimental group showed development in critical thinking, practical skills, autonomy, and taking responsibility, thus development in the competence level.
CONCLUSION


Implementation of self-assessment within preclinical courses may develop skills and competence among dental students, yet more studies are needed.",2021,"RESULTS


Subjects from the experimental group showed development in critical thinking, practical skills, autonomy, and taking responsibility, thus development in the competence level.
","['dental students in a private dental school according to the European qualifications framework descriptors', 'Fifteen subjects were included in each of the experimental and control groups during one semester', 'dental students', 'Thirty subjects, all fourth-year dental students']",[],"['critical thinking, practical skills, autonomy, and taking responsibility, thus development in the competence level']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0282354', 'cui_str': 'Descriptor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",15.0,0.0163287,"RESULTS


Subjects from the experimental group showed development in critical thinking, practical skills, autonomy, and taking responsibility, thus development in the competence level.
","[{'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Saadé', 'Affiliation': 'Department of Removable Prosthodontics, Faculty of Dental Medicine, Saint-Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Wassim', 'Initials': 'W', 'LastName': 'El-Khatib', 'Affiliation': 'Faculty of Education, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Nada R', 'Initials': 'NR', 'LastName': 'Chedid', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dental Medicine, Saint-Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Makzoumé', 'Affiliation': 'Department of Removable Prosthodontics, Faculty of Dental Medicine, Saint-Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Mohammad Tarek', 'Initials': 'MT', 'LastName': 'El-Halabi', 'Affiliation': 'Faculty of Education, Saint-Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'El-Hage', 'Affiliation': 'Faculty of Education, Saint-Joseph University, Beirut, Lebanon.'}]",Journal of dental education,['10.1002/jdd.12821']
2797,34761749,Opioid antagonism modulates wanting-related frontostriatal connectivity.,"Theoretical accounts distinguish between motivational ('wanting') and hedonic ('liking') dimensions of rewards. Previous animal and human research linked wanting and liking to anatomically and neurochemically distinct brain mechanisms, but it remains unknown how the different brain regions and neurotransmitter systems interact in processing distinct reward dimensions. Here, we assessed how pharmacological manipulations of opioid and dopamine receptor activation modulate the neural processing of wanting and liking in humans in a randomized, placebo-controlled, double-blind clinical trial. Reducing opioid receptor activation with naltrexone selectively reduced wanting of rewards, which on a neural level was reflected by stronger coupling between dorsolateral prefrontal cortex and the striatum under naltrexone compared with placebo. In contrast, reducing dopaminergic neurotransmission with amisulpride revealed no robust effects on behavior or neural activity. Our findings thus provide insights into how opioid receptors mediate neural connectivity related to specifically motivational, not hedonic, aspects of rewards.",2021,"Reducing opioid receptor activation with naltrexone selectively reduced wanting of rewards, which on a neural level was reflected by stronger coupling between dorsolateral prefrontal cortex and the striatum under naltrexone compared with placebo.",[],"['opioid and dopamine receptor activation', 'naltrexone', 'amisulpride', 'Opioid antagonism', 'placebo']",['behavior or neural activity'],[],"[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0034798', 'cui_str': 'Dopamine receptor'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.265882,"Reducing opioid receptor activation with naltrexone selectively reduced wanting of rewards, which on a neural level was reflected by stronger coupling between dorsolateral prefrontal cortex and the striatum under naltrexone compared with placebo.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Soutschek', 'Affiliation': 'Ludwig Maximilian University Munich, Munich, Germany.'}, {'ForeName': 'Susanna C', 'Initials': 'SC', 'LastName': 'Weber', 'Affiliation': 'University of Zurich, Zürich, Switzerland.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kahnt', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, United States.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Philippe N', 'Initials': 'PN', 'LastName': 'Tobler', 'Affiliation': 'University of Zurich, Zürich, Switzerland.'}]",eLife,['10.7554/eLife.71077']
2798,34761730,Effectiveness of game-based meditation therapy on neurobiological stress systems in adolescents with posttraumatic symptoms: a randomized controlled trial.,"Many adolescents in residential care have experienced traumatic events and suffer from posttraumatic stress. Prolonged activation of neurobiological stress systems as the autonomic nervous system (ANS) and the hypothalamic-pituitary-adrenal (HPA) axis can result in long-lasting maladaptive alternations. This study investigated the effectiveness of  Muse , a game-based meditation intervention, on the sympathetic nervous system (SNS), parasympathetic nervous system (PNS), and cortisol basal activity and reactivity to acute stress among adolescents with posttraumatic symptoms in residential care. The intervention consisted of two gameplay sessions a week, for 6 consecutive weeks. Seventy-seven adolescents with clinical levels of posttraumatic symptoms (10-18 years old) received either  Muse  as an addition to treatment as usual ( n  = 40) or treatment as usual alone ( n  = 37). We expected reduced basal activity for the SNS and cortisol and increased basal activity for the PNS. As for the response to acute stress, we expected decreased PNS and increased HPA axis reactivity. The Muse group exhibited lower basal activity for the SNS and increased HPA reactivity to acute stress. There were no differences between conditions on SNS and HPA axis activity during rest and on SNS and PNS reactivity to acute stress. Game-based meditation therapy is a promising intervention for the treatment of adolescents with posttraumatic symptoms in residential care. Implications for clinical relevance and trauma-focused treatment purposes are discussed.",2021,There were no differences between conditions on SNS and HPA axis activity during rest and on SNS and PNS reactivity to acute stress.,"['adolescents with posttraumatic symptoms', 'adolescents with posttraumatic symptoms in residential care', 'Seventy-seven adolescents with clinical levels of posttraumatic symptoms (10-18\u2009years old']","['Muse , a game-based meditation intervention', 'Muse  as an addition to treatment as usual ( n \u2009=\u200940) or treatment as usual alone', 'Game-based meditation therapy', 'game-based meditation therapy']","['HPA reactivity', 'basal activity', 'sympathetic nervous system (SNS), parasympathetic nervous system (PNS), and cortisol basal activity and reactivity to acute stress', 'HPA axis reactivity', 'neurobiological stress systems', 'SNS and HPA axis activity']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C2366566', 'cui_str': 'Muse'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0030510', 'cui_str': 'Parasympathetic nervous system structure'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",77.0,0.0869861,There were no differences between conditions on SNS and HPA axis activity during rest and on SNS and PNS reactivity to acute stress.,"[{'ForeName': 'Angela A T', 'Initials': 'AAT', 'LastName': 'Schuurmans', 'Affiliation': 'Department of Research and Development, Pluryn, Nijmegen, the Netherlands.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Nijhof', 'Affiliation': 'Department of Research and Development, Pluryn, Nijmegen, the Netherlands.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Scholte', 'Affiliation': 'Behavioural Science Institute, Radboud University Nijmegen, Nijmegen, the Netherlands.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Popma', 'Affiliation': 'Department of Child and Adolescent Psychiatry, VUmc/De Bascule, Amsterdam, the Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Otten', 'Affiliation': 'Department of Research and Development, Pluryn, Nijmegen, the Netherlands.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2021.1998444']
2799,34761713,"The effect of dapagliflozin on ventricular arrhythmias, cardiac arrest, or sudden death in people with heart failure: a tick in another box for sodium-glucose cotransporter 2 inhibitors.","INTRODUCTION


Despite the progress made in the treatment of heart failure with reduced ejection fraction (HFrEF) in recent years, the prognosis of the disease remains poor, with ventricular arrhythmias (VA) contributing significantly to increased mortality.
AREAS COVERED


A recently published  post hoc  analysis of the DAPA-HF trial evaluated the effect of the sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin versus placebo on the incidence of VA, resuscitated cardiac arrest, or sudden death among people with HFrEF. During a median follow-up of 18.2 months, the composite primary outcome occurred in 140 (5.9%) people who received dapagliflozin compared to 175 (7.4%) participants in the placebo arm (hazard ratio 0.79; 95 confidence interval 0.63-0.99, P=0.037). Animal studies suggest that SGLT2i could ameliorate the deleterious effects of myocardial injury, through various mechanisms, including reduced sympathetic activity, improved oxidative stress, tissue oxygenation, autophagy, heart energy metabolism, and promotion of cardiac remodeling.
EXPERT OPINION


Taken together, the above findings indicate a place for SGLT2i in future trials investigating novel treatments to improve survival in patients with acute cardiovascular episodes. This is primarily applicable for acute decompensated HF; however, their use could also be evaluated in other conditions that induce VA, such as acute coronary syndromes.",2021,"During a median follow-up of 18.2 months, the composite primary outcome occurred in 140 (5.9%) people who received dapagliflozin compared to 175 (7.4%) participants in the placebo arm (hazard ratio 0.79; 95 confidence interval 0.63-0.99, P=0.037).","['people with HFrEF', 'patients with acute cardiovascular episodes', 'people with heart failure']","['dapagliflozin', 'placebo', 'SGLT2i', 'sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin versus placebo']","['incidence of VA, resuscitated cardiac arrest, or sudden death', 'ventricular arrhythmias, cardiac arrest, or sudden death']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}]",,0.321259,"During a median follow-up of 18.2 months, the composite primary outcome occurred in 140 (5.9%) people who received dapagliflozin compared to 175 (7.4%) participants in the placebo arm (hazard ratio 0.79; 95 confidence interval 0.63-0.99, P=0.037).","[{'ForeName': 'Theocharis', 'Initials': 'T', 'LastName': 'Koufakis', 'Affiliation': 'Division of Endocrinology and Metabolism and Diabetes Center, First Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakoulas', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Zebekakis', 'Affiliation': 'Division of Endocrinology and Metabolism and Diabetes Center, First Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Kotsa', 'Affiliation': 'Division of Endocrinology and Metabolism and Diabetes Center, First Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}]",Expert opinion on pharmacotherapy,['10.1080/14656566.2021.2003329']
2800,34761694,"Peripheral nerve stimulation for the management of acute and subacute post-amputation pain: a randomized, controlled feasibility trial.","Introduction & aim:  Temporary (60-day) percutaneous peripheral nerve stimulation (PNS) has demonstrated effectiveness for the treatment of chronic post-amputation pain, and this pilot study aims to evaluate the feasibility of temporary percutaneous PNS for the treatment of acute post-amputation pain.  Patients & methods:  Sixteen veterans undergoing lower extremity amputation received PNS and standard medical therapy or standard medical therapy alone.  Results:  The PNS group reported greater reductions in average phantom limb pain, residual limb pain and daily opioid consumption, and there were fewer participants taking opioids through 3 months post-amputation.  Conclusion:  This pilot study suggests that PNS is feasible in the acute postoperative period following lower limb amputation and may provide a non-pharmacologic analgesic therapy that lowers pain scores and reduces opioid consumption, and thus warrants further investigation.",2021,"The PNS group reported greater reductions in average phantom limb pain, residual limb pain and daily opioid consumption, and there were fewer participants taking opioids through 3 months post-amputation.  ","['acute and subacute post-amputation pain', 'Patients & methods:  Sixteen veterans undergoing lower extremity amputation received']","['PNS and standard medical therapy or standard medical therapy alone', 'temporary percutaneous PNS', 'PNS', 'Temporary (60-day) percutaneous peripheral nerve stimulation (PNS', 'Peripheral nerve stimulation']","['pain scores', 'average phantom limb pain, residual limb pain and daily opioid consumption']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}]","[{'cui': 'C0206417', 'cui_str': 'Peripheral nervous system structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",16.0,0.0426671,"The PNS group reported greater reductions in average phantom limb pain, residual limb pain and daily opioid consumption, and there were fewer participants taking opioids through 3 months post-amputation.  ","[{'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Albright-Trainer', 'Affiliation': 'Department of Anesthesiology, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Phan', 'Affiliation': 'Department of Physical Medicine & Rehab, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Trainer', 'Affiliation': 'Department of Physical Medicine & Rehab, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Crosby', 'Affiliation': 'SPR Therapeutics, Cleveland, OH\xa044122, USA.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Murphy', 'Affiliation': 'Department of Physical Medicine & Rehab, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Disalvo', 'Affiliation': 'Department of Physical Medicine & Rehab, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Amendola', 'Affiliation': 'Department of Surgery, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Denise D', 'Initials': 'DD', 'LastName': 'Lester', 'Affiliation': 'Department of Physical Medicine & Rehab, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}]",Pain management,['10.2217/pmt-2021-0087']
2801,34761622,Development and validation of a nomogram for specific survival in osteosarcoma patients less than 60 years old: a population-based study.,"PURPOSE


The present study aimed to develop a nomogram to predict the overall survival of patients with osteosarcoma, especially those less than 60 years old.
METHODS


903 osteosarcoma patients less than 60 years old were collected from the Surveillance, Epidemiology, and End Results (SEER) database.Univariate and multivariate analyses identified the independent prognostic factors of osteosarcoma. Nomogram was used to predict 3- and 5-year overall survival (OS) of osteosarcoma.The accuracy of the model was determined using the concordance index (C‑index), calibration curves, the area under the receiver operating characteristic curves (ROC),as well as decision curve analysis (DCA).
RESULTS


Osteosarcoma patients less than 60 years old were randomly assigned into a training cohort (n=635) or validation cohort (n=268). Age, tumor site, tumor grade, tumor size, and tumor stage were identified as independent prognostic factors via univariate and multivariate Cox analyses (all p<0.05) and then included in the prognostic nomogram. The concordance indices(C-index) for OS prediction in the training cohort was 0.788 (95% CI 0.751-0.852) and in the external validation cohort was 0.779 (95% CI 0.712-0.846). Calibration plots and the area under the ROC revealed excellent consistency between actual survival and nomogram prediction. Finally, DCA demonstrated that the prognostic nomogram was clinically meaningful.
CONCLUSION


A nomogram could accurately predict the OS of osteosarcoma patients less than 60 years old and contribute to making better clinical treatment decisions for the treating doctors.",2021,The concordance indices(C-index) for OS prediction in the training cohort was 0.788,"['patients with osteosarcoma, especially those less than 60 years old', 'Osteosarcoma patients less than 60 years old', '903 osteosarcoma patients less than 60 years old were collected from the Surveillance, Epidemiology, and End Results (SEER) database', 'osteosarcoma patients less than 60 years old']",[],"['overall survival', 'concordance index (C‑index), calibration curves, the area under the receiver operating characteristic curves (ROC),as well as decision curve analysis (DCA', '5-year overall survival (OS) of osteosarcoma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0037501', 'cui_str': 'Sodium Dichloroacetate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}]",903.0,0.0999999,The concordance indices(C-index) for OS prediction in the training cohort was 0.788,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Zhuhai Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Zhuhai, Guandong, China.'}, {'ForeName': 'Jianfei', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Mu', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
2802,34761610,Treatment effect of concurrent chemoradiotherapy after surgery and its effect on postoperative swallowing function of patients with locally advanced hypopharyngeal carcinoma.,"PURPOSE


To study the treatment effect of concurrent chemoradiotherapy (CCRT) after surgery and its effect on postoperative swallowing function of patients with locally advanced hypopharyngeal carcinoma.
METHODS


The clinical data of 84 patients with advanced hypopharyngeal carcinoma treated in our hospital were retrospectively analyzed. The patients were randomly divided into experimental group and control group, with 42 cases in each group. After both groups of patients were treated with radical neck dissection, the control group received adjuvant radiotherapy while the experimental group received CCRT.
RESULTS


The Burke score in the experimental group after treatment was significantly lower than that in the control group (p<0.001). The objective remission rate in the experimental group was significantly higher than that in the control group (p<0.05). The jitter and shimmer in the experimental group after treatment were significantly lower than those in the control group (p<0.05). The quality of life scores of patients in the two groups after treatment were significantly higher than those before treatment (p<0.001), and the quality of life score in the experimental group was significantly higher than that in the control group (p<0.001). And the incidence of gastrointestinal reactions and neutropenia in the experimental group after treatment was significantly lower than that in the control group (p<0.05). The 3-year cumulative survival rate after surgery in the experimental group was significantly higher than in the control group (p<0.05).
CONCLUSIONS


CCRT after surgery can effectively improve the swallowing function of patients with locally advanced hypopharyngeal carcinoma, which is worthy of promotion and application.",2021,The objective remission rate in the experimental group was significantly higher than that in the control group (p<0.05).,"['84 patients with advanced hypopharyngeal carcinoma treated in our hospital were retrospectively analyzed', 'patients with locally advanced hypopharyngeal carcinoma']","['concurrent chemoradiotherapy (CCRT', 'concurrent chemoradiotherapy', 'radical neck dissection', 'adjuvant radiotherapy', 'CCRT']","['swallowing function', 'Burke score', 'objective remission rate', 'quality of life score', 'gastrointestinal reactions and neutropenia', '3-year cumulative survival rate', 'postoperative swallowing function', 'quality of life scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0034542', 'cui_str': 'Radical neck dissection'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}]","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010456', 'cui_str': 'Cumulative Survival Rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",84.0,0.0213459,The objective remission rate in the experimental group was significantly higher than that in the control group (p<0.05).,"[{'ForeName': 'Xiaoxu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology,the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, P.R.China.'}, {'ForeName': 'Liuzhong', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
2803,34761595,Clinical analysis of 125I seed implantation combined with epidermal growth factor receptor-tyrosine kinase inhibitors in advanced non-small cell lung cancer.,"PURPOSE


To explore the efficacy and safety of 125I radioactive seed implantation combined with epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) in the treatment of advanced non-small cell lung cancer (NSCLC).
METHODS


108 patients with EGFR mutation-positive unresectable advanced NSCLC (stage IIIB-IV) were randomly divided into 125I group (treated with 125I radioactive seed implantation combined with EGFR-TKIs, n=54) and EGFR-TKIs group (treated with EGFR-TKIs alone, n=54). The short-term efficacy and adverse reactions were analyzed and evaluated, the changes in the levels of peripheral blood T lymphocyte subsets, natural killer (NK) cells and related immune-inflammatory factors were analyzed, and the long-term survival and progression of disease were recorded.
RESULTS


The objective response rate was 61.1% (33/54) and 51.9% (28/54), and the disease control rate was 88.9% (48/54) and 68.5% (37/54), respectively, in 125I group and EGFR-TKIs group. At 6 months after treatment, the levels of peripheral blood cluster of differentiation 3+ (CD3+), CD4+, CD4+/CD8+ and NK cells significantly rose in both groups compared with those before treatment (p<0.05), while the levels of CD8+, serum tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ), interleukin-6 (IL-6) and IL-10 significantly declined compared with those before treatment. The 2-year overall survival (OS) rate was 53.7% (29/54) and 40.7% (22/54), and the median progression-free survival (PFS) was 14.5 months and 9.8 months, respectively, in 125I group and EGFR-TKIs group.
CONCLUSIONS


125I radioactive seed implantation combined with EGFR-TKIs is safe and effective in the treatment of advanced NSCLC, and its short-term efficacy and long-term survival rate of patients are significantly superior to those of EGFR-TKIs alone. At the same time, it can regulate the expressions of T lymphocyte subsets, NK cells and immune-inflammatory factors in patients, and improve their immune function.",2021,"The objective response rate was 61.1% (33/54) and 51.9% (28/54), and the disease control rate was 88.9% (48/54) and 68.5% (37/54), respectively, in 125I group and EGFR-TKIs group.","['advanced non-small cell lung cancer (NSCLC', '108 patients with EGFR mutation-positive unresectable advanced NSCLC (stage IIIB-IV', 'advanced non-small cell lung cancer']","['125I seed implantation combined with epidermal growth factor receptor-tyrosine kinase inhibitors', '125I radioactive seed implantation combined with epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs', '125I radioactive seed implantation combined with EGFR-TKIs, n=54) and EGFR-TKIs group (treated with EGFR-TKIs alone']","['levels of CD8+, serum tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ), interleukin-6 (IL-6) and IL-10', 'median progression-free survival (PFS', 'objective response rate', 'expressions of T lymphocyte subsets, NK cells and immune-inflammatory factors', 'levels of peripheral blood cluster of differentiation 3+ (CD3+), CD4+, CD4+/CD8+ and NK cells', 'disease control rate', '2-year overall survival (OS) rate', 'levels of peripheral blood T lymphocyte subsets, natural killer (NK) cells and related immune-inflammatory factors', 'short-term efficacy and adverse reactions', 'long-term survival and progression of disease']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}]","[{'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0034553', 'cui_str': 'Radioactivity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0080202', 'cui_str': 'T-Cell Subsets'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",108.0,0.133576,"The objective response rate was 61.1% (33/54) and 51.9% (28/54), and the disease control rate was 88.9% (48/54) and 68.5% (37/54), respectively, in 125I group and EGFR-TKIs group.","[{'ForeName': 'Xiaoshan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Process Development, Beijing Yisheng Biotechnology Co., Ltd., Beijing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
2804,34762057,Mobile Diary App Versus Paper-Based Diary Cards for Patients With Borderline Personality Disorder: Economic Evaluation.,"BACKGROUND


The cost-effectiveness of using a mobile diary app as an adjunct in dialectical behavior therapy (DBT) in patients with borderline personality disorder is unknown.
OBJECTIVE


This study aims to perform an economic evaluation of a mobile diary app compared with paper-based diary cards in DBT treatment for patients with borderline personality disorder in a psychiatric outpatient facility.
METHODS


This study was conducted alongside a pragmatic, multicenter, randomized controlled trial. The participants were recruited at 5 Danish psychiatric outpatient facilities and were randomized to register the emotions, urges, and skills used in a mobile diary app or on paper-based diary cards. The participants in both groups received DBT delivered by the therapists. A cost-consequence analysis with a time horizon of 12 months was performed. Consequences included quality-adjusted life years (QALYs), depression severity, borderline severity, suicidal behavior, health care use, treatment compliance, and system usability. All relevant costs were included. Focus group interviews were conducted with patients, therapists, researchers, and industry representatives to discuss the potential advantages and disadvantages of using a mobile diary app.
RESULTS


A total of 78 participants were included in the analysis. An insignificantly higher number of participants in the paper group dropped out before the start of treatment (P=.07). Of those starting treatment, participants in the app group had an average of 37.1 (SE 27.55) more days of treatment and recorded an average of 3.16 (SE 5.10) more skills per week than participants in the paper group. Participants in both groups had a QALY gain and a decrease in depression severity, borderline severity, and suicidal behavior. Significant differences were found in favor of the paper group for both QALY gain (adjusted difference -0.054; SE 0.03) and reduction in depression severity (adjusted difference -1.11; SE 1.57). The between-group difference in total costs ranged from US $107.37 to US $322.10 per participant during the 12 months. The use of services in the health care sector was similar across both time points and groups (difference: psychiatric hospitalization <5 and <5; general practice -1.32; SE 3.68 and 2.02; SE 3.19). Overall, the patients showed high acceptability and considered the app as being easy to use. Therapists worried about potential negative influences on the therapist-patient interaction from new work tasks accompanying the introduction of the new technology but pointed at innovation potential from digital database registrations.
CONCLUSIONS


This study suggests both positive and negative consequences of mobile diary apps as adjuncts to DBT compared with paper diary cards. More research is needed to draw conclusions regarding its cost-effectiveness.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03191565; http://clinicaltrials.gov/ct2/show/NCT03191565.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/17737.",2021,Significant differences were found in favor of the paper group for both QALY gain (adjusted difference -0.054; SE 0.03) and reduction in depression severity (adjusted difference -1.11; SE 1.57).,"['patients with borderline personality disorder in a psychiatric outpatient facility', 'participants were recruited at 5 Danish psychiatric outpatient facilities', 'A total of 78 participants were included in the analysis', 'Patients With Borderline Personality Disorder', 'patients with borderline personality disorder']","['Mobile Diary App Versus Paper-Based Diary Cards', 'mobile diary app compared with paper-based diary cards in DBT treatment', 'mobile diary app or on paper-based diary cards', 'dialectical behavior therapy (DBT', 'DBT']","['depression severity, borderline severity, and suicidal behavior', 'quality-adjusted life years (QALYs), depression severity, borderline severity, suicidal behavior, health care use, treatment compliance, and system usability', 'QALY gain', 'depression severity', 'total costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",78.0,0.12582,Significant differences were found in favor of the paper group for both QALY gain (adjusted difference -0.054; SE 0.03) and reduction in depression severity (adjusted difference -1.11; SE 1.57).,"[{'ForeName': 'Sidsel Lund', 'Initials': 'SL', 'LastName': 'Laursen', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Healthcare Improvements, Aalborg University, Aalborg Oest, Denmark.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Helweg-Jørgensen', 'Affiliation': 'Research Unit for Telepsychiatry and E-mental Health, Mental Health Services in the Region of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Langergaard', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Healthcare Improvements, Aalborg University, Aalborg Oest, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Søndergaard', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Healthcare Improvements, Aalborg University, Aalborg Oest, Denmark.'}, {'ForeName': 'Sabrina Storgaard', 'Initials': 'SS', 'LastName': 'Sørensen', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Healthcare Improvements, Aalborg University, Aalborg Oest, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mathiasen', 'Affiliation': 'Research Unit for Telepsychiatry and E-mental Health, Mental Health Services in the Region of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Mia Beck', 'Initials': 'MB', 'LastName': 'Lichtenstein', 'Affiliation': 'Research Unit for Telepsychiatry and E-mental Health, Mental Health Services in the Region of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Lars Holger', 'Initials': 'LH', 'LastName': 'Ehlers', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Healthcare Improvements, Aalborg University, Aalborg Oest, Denmark.'}]",Journal of medical Internet research,['10.2196/28874']
2805,34761854,A trial of a six-month sugar-sweetened beverage intervention in secondary schools from a socio-economically disadvantaged region in Australia.,"OBJECTIVE


This study assessed the effectiveness of a school-based intervention in reducing adolescents' sugar-sweetened beverage (SSB) consumption and percentage of energy from SSBs. Secondary outcomes were SSB consumption within school, average daily energy intake, and body mass index z-scores.
METHODS


Six secondary schools located in New South Wales, Australia were recruited to participate in a six-month pilot randomised controlled trial (1:1). The intervention included components targeting the school nutrition environment, curricula and community. Outcomes were collected via online surveys, observations, anthropometric measurements and project records. Between-group differences were assessed via linear mixed models.
RESULTS


At the six-month intervention endpoint (n=862) there were no statistically significant differences between students in intervention or control schools for mean daily intake of SSBs (8.55mL; CI -26.77, 43.87; p=0.63), percentage daily energy from SSBs (0.12% kJ; CI -0.55, 0.80; p=0.72), or for secondary outcomes. Acceptability of the school-based strategies were high, however intervention fidelity varied across schools.
CONCLUSION


While acceptable, improving fidelity of implementation and increasing the duration or intensity of the intervention may be required to reduce SSB intake. Implications for public health: Engaging parents and education stakeholders in the development phase to co-design interventions may prove beneficial in improving intervention fidelity and enhance behavioural outcomes.",2021,"At the six-month intervention endpoint (n=862) there were no statistically significant differences between students in intervention or control schools for mean daily intake of SSBs (8.55mL; CI -26.77, 43.87; p=0.63), percentage daily energy from SSBs (0.12% kJ; CI -0.55, 0.80; p=0.72), or for secondary outcomes.","['Six secondary schools located in New South Wales, Australia', 'secondary schools from a socio-economically disadvantaged region in Australia', 'public health']","['school-based intervention', 'six-month sugar-sweetened beverage intervention']","['mean daily intake of SSBs', ""adolescents' sugar-sweetened beverage (SSB) consumption and percentage of energy from SSBs"", 'percentage daily energy from SSBs', 'SSB consumption within school, average daily energy intake, and body mass index z-scores']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.0818793,"At the six-month intervention endpoint (n=862) there were no statistically significant differences between students in intervention or control schools for mean daily intake of SSBs (8.55mL; CI -26.77, 43.87; p=0.63), percentage daily energy from SSBs (0.12% kJ; CI -0.55, 0.80; p=0.72), or for secondary outcomes.","[{'ForeName': 'Jia Ying', 'Initials': 'JY', 'LastName': 'Ooi', 'Affiliation': 'Hunter New England Population Health, New South Wales.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'Hunter New England Population Health, New South Wales.'}, {'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'Hunter New England Population Health, New South Wales.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Janssen', 'Affiliation': 'Hunter New England Population Health, New South Wales.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Reilly', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, New South Wales.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nathan', 'Affiliation': 'Hunter New England Population Health, New South Wales.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'Hunter New England Population Health, New South Wales.'}]",Australian and New Zealand journal of public health,['10.1111/1753-6405.13159']
2806,34762233,Effects of Transcutaneous Electrical Acupoint Stimulation on Ovarian Responses and Pregnancy Outcomes in Patients Undergoing IVF-ET: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the influence of different transcutaneous electrical acupoint stimulation (TEAS) modes on ovarian responses and pregnancy outcomes in patients with infertility undergoing in vitro fertilization and embryo transfer (IVF-ET).
METHODS


Two hundred infertility patients undergoing IVF-ET were divided randomly into experimental groups (TEAS groups: E-I, E-II, E-III, and E-IV, 40 cases each group) and a control group (mock TEAS group, 40 patients) using the random number method. The patients in the experimental groups received TEAS treatment of 20, 30, 40 and 50 mA for the E-I, E-II, E-III and E-IV groups, respectively. The control group received a treatment of 5 mA. TEAS was applied at acupoints of Guanyuan (RN 4), Zhongji (RN 3), Sanyinjiao (SP 6), Zigong (EX-CA 1), and Taixi (KI 13), once a day for 30 min each time for a treatment period of 10-13 d. Treatment effect was assessed using the following indicators: endometrial thickness on the 6th day of gonadotropin treatment (GN6 day), endometrial thickness on the day on chorionic gonadotropin administration (HCG day), number of ovarian follicles on HCG day, number of ova captured, amount of estrogen required for each harvested ova, number of mature ova divided by the total number of ova, percentage of high-quality embryos, and clinical pregnancy.
RESULTS


Endometrial thickness in the experimental groups on the HCG day was significantly better than that of the control group after TEAS stimulation (P=0.01). TEAS exhibited a greater impact on the number of ova captured (P=0.003). However, the effect of TEAS stimulation on the high-quality embryo rate and clinical pregnancy in patients was not statistically significant (P>0.05).
CONCLUSIONS


TEAS is an effective method in improving the ovarian state. When the stimulus intensity was at 40 mA and above, it could be helpful to improve the patient's endometrial condition and endometrial receptivity and to retrieve more oocytes. (Trial registration No. ChiCTR-TRC-11001780).",2021,Endometrial thickness in the experimental groups on the HCG day was significantly better than that of the control group after TEAS stimulation (P=0.01).,"['Two hundred infertility patients undergoing IVF-ET', 'Patients Undergoing IVF-ET', 'patients with infertility undergoing in vitro fertilization and embryo transfer (IVF-ET']","['gonadotropin treatment (GN6 day), endometrial thickness on the day on chorionic gonadotropin administration (HCG day), number of ovarian follicles on HCG day, number of ova captured, amount of estrogen', 'control group (mock TEAS', 'transcutaneous electrical acupoint stimulation (TEAS) modes', 'Transcutaneous Electrical Acupoint Stimulation', 'TEAS', 'TEAS was applied at acupoints of Guanyuan (RN 4), Zhongji (RN 3), Sanyinjiao (SP 6), Zigong (EX-CA 1), and Taixi (KI 13']","['high-quality embryo rate and clinical pregnancy', 'Ovarian Responses and Pregnancy Outcomes', 'Endometrial thickness', 'number of ova captured', 'ovarian responses and pregnancy outcomes']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018062', 'cui_str': 'Chorionic Gonadotropin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0029974', 'cui_str': 'Ovum'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0562577', 'cui_str': 'Mocking'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0626533', 'cui_str': 'SP 6'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029974', 'cui_str': 'Ovum'}]",200.0,0.051362,Endometrial thickness in the experimental groups on the HCG day was significantly better than that of the control group after TEAS stimulation (P=0.01).,"[{'ForeName': 'Zhi-Jin', 'Initials': 'ZJ', 'LastName': 'Zhai', 'Affiliation': 'Department of Reproductive Medicine, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, 100026, China.'}, {'ForeName': 'Jia-En', 'Initials': 'JE', 'LastName': 'Liu', 'Affiliation': 'Center for Reproductive Medicine, Beijing Jia-En De Yun Hospital, Beijing, 100089, China.'}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Lei', 'Affiliation': 'Department of Reproductive Medicine, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, 100026, China.'}, {'ForeName': 'Shu-Yu', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': 'Department of Reproductive Medicine, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, 100026, China. wangshuyu@ccmu.edu.cn.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-3457-8']
2807,34762211,"Moderate-intensity continuous training and high-intensity interval training improve cognition, and BDNF levels of middle-aged overweight men.","The prevalence of overweight and obesity is increasing worldwide, which has been associated with poor cognitive outcomes. Participating in regular physical exercise may also improve cognition, and levels of brain-derived neurotrophic factor (BDNF), but the optimal exercise prescription remains to be elucidated. The purpose of the present study is to compare the effects of moderate intensity continuous training (MICT) and high intensity interval training (HIIT) on cognition, and serum BDNF levels in middle-aged and overweight men. Twenty-five sedentary, overweight men participated in the 8-week training intervention. Subjects were randomized into MICT (n = 12) or HIIT (n = 13) and performed exercise sessions 3x/week for 8-weeks. Cognitive function, and serum BDNF levels were assessed pre- and post-intervention. Statistical analysis was carried out using the Graph Pad Prism 7.0, and the level of significance was set at 5%. Significant improvements were observed in cognitive test scores, and BDNF levels in MICT and HIIT groups (p < 0.05). There were no significant differences in cognitive function between MICT and HIIT. The present study implicates that 8 weeks of MICT or HIIT may be a very useful non-pharmacological treatment option to improve cognitive function, and BDNF levels in middle-aged overweight men.",2021,"Significant improvements were observed in cognitive test scores, and BDNF levels in MICT and HIIT groups (p < 0.05).","['middle-aged and overweight men', 'Twenty-five sedentary, overweight men participated in the', 'middle-aged overweight men']","['moderate intensity continuous training (MICT) and high intensity interval training (HIIT', 'MICT or HIIT', '8-week training intervention', 'MICT', 'Moderate-intensity continuous training and high-intensity interval training', 'regular physical exercise']","['cognition, and BDNF levels', 'cognition, and serum BDNF levels', 'cognitive function, and BDNF levels', 'Cognitive function, and serum BDNF levels', 'cognitive function', 'cognition, and levels of brain-derived neurotrophic factor (BDNF', 'cognitive test scores, and BDNF levels']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.010694,"Significant improvements were observed in cognitive test scores, and BDNF levels in MICT and HIIT groups (p < 0.05).","[{'ForeName': 'Neumir Sales', 'Initials': 'NS', 'LastName': 'de Lima', 'Affiliation': 'Physical Education Department, Federal University of the Valleys of Jequitinhonha and Mucuri (UFVJM), Rodovia MGT 367 - Km 583, n° 5000, Diamantina, MG, CEP 39100-000, Brazil.'}, {'ForeName': 'Ricardo Augusto Leoni', 'Initials': 'RAL', 'LastName': 'De Sousa', 'Affiliation': 'Physical Education Department, Federal University of the Valleys of Jequitinhonha and Mucuri (UFVJM), Rodovia MGT 367 - Km 583, n° 5000, Diamantina, MG, CEP 39100-000, Brazil.'}, {'ForeName': 'Fabiano Trigueiro', 'Initials': 'FT', 'LastName': 'Amorim', 'Affiliation': 'Department of Health, Exercise & Sports Sciences, University of New Mexico, Albuquerque, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Gripp', 'Affiliation': 'Physical Education Department, Federal University of the Valleys of Jequitinhonha and Mucuri (UFVJM), Rodovia MGT 367 - Km 583, n° 5000, Diamantina, MG, CEP 39100-000, Brazil.'}, {'ForeName': 'Caíque Olegário', 'Initials': 'CO', 'LastName': 'Diniz E Magalhães', 'Affiliation': 'Physical Education Department, Federal University of the Valleys of Jequitinhonha and Mucuri (UFVJM), Rodovia MGT 367 - Km 583, n° 5000, Diamantina, MG, CEP 39100-000, Brazil.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Henrique Pinto', 'Affiliation': 'Physical Education Department, Federal University of the Valleys of Jequitinhonha and Mucuri (UFVJM), Rodovia MGT 367 - Km 583, n° 5000, Diamantina, MG, CEP 39100-000, Brazil.'}, {'ForeName': 'Marco Fabrício Dias', 'Initials': 'MFD', 'LastName': 'Peixoto', 'Affiliation': 'Physical Education Department, Federal University of the Valleys of Jequitinhonha and Mucuri (UFVJM), Rodovia MGT 367 - Km 583, n° 5000, Diamantina, MG, CEP 39100-000, Brazil.'}, {'ForeName': 'Renato Sobral', 'Initials': 'RS', 'LastName': 'Monteiro-Junior', 'Affiliation': 'Physical Education and Sport Department, State University of Montes Claros, Montes Claros, MG, Brazil.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Bourbeau', 'Affiliation': 'Department of Health, Exercise & Sports Sciences, University of New Mexico, Albuquerque, USA.'}, {'ForeName': 'Ricardo Cardoso', 'Initials': 'RC', 'LastName': 'Cassilhas', 'Affiliation': 'Physical Education Department, Federal University of the Valleys of Jequitinhonha and Mucuri (UFVJM), Rodovia MGT 367 - Km 583, n° 5000, Diamantina, MG, CEP 39100-000, Brazil. rcassilhas@yahoo.com.br.'}]",Metabolic brain disease,['10.1007/s11011-021-00859-5']
2808,34762378,[Effect of acupuncture for regulating spleen and stomach on aspirin resistance in patients with type 2 diabetes mellitus: a randomized controlled trial].,"OBJECTIVE


To observe the effect of acupuncture for regulating spleen and stomach on aspirin resistance in patients with type 2 diabetes mellitus (T2DM) and explore the effect mechanism.
METHODS


A total of 68 T2DM patients complicated with aspirin resistance were randomized into an observation group and a control group, 34 cases in each one. On the base of the conventional treatment for diabetes, aspirin enteric-coated tablets were prescribed for oral administration, 100 mg each time, once daily in the control group. In the observation group, on the basis of the treatment as the control group, acupuncture was used for regulating spleen and stomach at Zhongwan (CV 12), Zusanli (ST 36), Yinlingquan (SP 9), Hegu (LI 4), etc., once daily. The treatment for 1 week was as one course and 4 courses of treatment were required totally in two groups. Before and After treatment, the indexes of platelet function (platelet aggregation rate [PAG] and salicylic acid concentration), the indexes of vascular endothelial function (6-keone prostaglandin F1α[6-keto-PGF1α], thromin B2 [TXB2] and cyclooxysynthase-2 [COX-2]), blood glucose (fasting plasma glucose [FPG], 2 h plasma glucose [2h PG] and glycosylated hemoglobin [HbA1c]), insulin resistance index (HOMA-IR), blood lipid indexes (total cholesterol [TC], triacylglycerol [TG], high-density lipoprotein cholesterol [HDL-C] and low-density lipoprotein cholesterol [LDL-C]) and the total score of TCM symptoms were observed in the patients of two groups. Clinical therapeutic effect and safety was compared in the patients between the two groups after treatment and the recurrence rate of cardiocerebrovascular events was followed up 6 months after treatment.
RESULTS


After treatment, PAG, salicylic acid concentration, TXB2, COX-2, FPG, 2h PG, HbA1c, HOMA-IR, LDL-C, TC, TG and the total scores of TCM symptoms were all reduced as compared with those before treatment in the two groups ( P <0.01,  P <0.05), and 6-keto-PGF1αand HDL-C were increased as compared with those before treatment in the two groups ( P <0.01,  P <0.05). In comparison with the control group, the aforementioned indexes in the observation group were all improved significantly ( P <0.01). The total effective rate was 91.2% (31/34) in the observation group, higher than 70.6% (24/34) in the control group ( P <0.05). In follow up visit, the recurrence rate of cardiocerebrovascular events was 14.7% (5/34) in the observation group, lower than 29.4% (10/34) in the control group ( P <0.05). The therapies were safe and had no obvious adverse reactions in both two groups.
CONCLUSION


Acupuncture for regulating spleen and stomach combined with aspirin enteric-coated tablets relieve insulin resistance and reduces blood glucose and lipid as well as the recurrence rate of cardiocerebrovascular events in the patients with T2DM, which is probably related to the regulation of insulin resistance and the improvement of vascular endothelial function. This combined therapy achieves the better effect on aspirin resistance as compared with simple aspirin enteric-coated tablets.",2021,"Before and After treatment, the indexes of platelet function (platelet aggregation rate [PAG] and salicylic acid concentration), the indexes of vascular endothelial function (6-keone prostaglandin F1α[6-keto-PGF1α], thromin B2 [TXB2] and cyclooxysynthase-2 [COX-2]), blood glucose (fasting plasma glucose [FPG], 2 h plasma glucose [2h PG] and glycosylated hemoglobin [HbA1c]), insulin resistance index (HOMA-IR), blood lipid indexes (total cholesterol [TC], triacylglycerol [TG], high-density lipoprotein cholesterol [HDL-C] and low-density lipoprotein cholesterol [LDL-C]) and the total score of TCM symptoms were observed in the patients of two groups.","['patients with T2DM', 'patients with type 2 diabetes mellitus (T2DM', 'patients with type 2 diabetes mellitus', '68 T2DM patients complicated with aspirin resistance']","['acupuncture', 'Acupuncture']","['total effective rate', '6-keto-PGF1αand HDL-C', 'blood glucose and lipid', 'recurrence rate of cardiocerebrovascular events', 'aspirin resistance', 'PAG, salicylic acid concentration, TXB2, COX-2, FPG, 2h PG, HbA1c, HOMA-IR, LDL-C, TC, TG and the total scores of TCM symptoms', 'indexes of platelet function (platelet aggregation rate [PAG] and salicylic acid concentration), the indexes of vascular endothelial function (6-keone prostaglandin F1α[6-keto-PGF1α], thromin B2 [TXB2] and cyclooxysynthase-2 [COX-2]), blood glucose (fasting plasma glucose [FPG], 2 h plasma glucose [2h PG] and glycosylated hemoglobin [HbA1c]), insulin resistance index (HOMA-IR), blood lipid indexes (total cholesterol [TC], triacylglycerol [TG], high-density lipoprotein cholesterol [HDL-C] and low-density lipoprotein cholesterol [LDL-C]) and the total score of TCM symptoms', 'Clinical therapeutic effect and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0228398', 'cui_str': 'Structure of periaqueductal gray matter'}, {'cui': 'C0036079', 'cui_str': 'Salicylic Acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040059', 'cui_str': 'Thromboxane B>2<'}, {'cui': 'C1565860', 'cui_str': 'PTGS2 protein, human'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",68.0,0.0419694,"Before and After treatment, the indexes of platelet function (platelet aggregation rate [PAG] and salicylic acid concentration), the indexes of vascular endothelial function (6-keone prostaglandin F1α[6-keto-PGF1α], thromin B2 [TXB2] and cyclooxysynthase-2 [COX-2]), blood glucose (fasting plasma glucose [FPG], 2 h plasma glucose [2h PG] and glycosylated hemoglobin [HbA1c]), insulin resistance index (HOMA-IR), blood lipid indexes (total cholesterol [TC], triacylglycerol [TG], high-density lipoprotein cholesterol [HDL-C] and low-density lipoprotein cholesterol [LDL-C]) and the total score of TCM symptoms were observed in the patients of two groups.","[{'ForeName': 'Yuan-Qing', 'Initials': 'YQ', 'LastName': 'Yang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Tianjin Academy of TCM, Tianjin 300120, China.'}, {'ForeName': 'Zhi-Long', 'Initials': 'ZL', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Tianjin Academy of TCM, Tianjin 300120, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Tianjin Academy of TCM, Tianjin 300120, China.'}, {'ForeName': 'Xing-Ya', 'Initials': 'XY', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Tianjin Academy of TCM, Tianjin 300120, China.'}, {'ForeName': 'Xiao-Tong', 'Initials': 'XT', 'LastName': 'Xing', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Tianjin Academy of TCM, Tianjin 300120, China.'}, {'ForeName': 'Jian-Bin', 'Initials': 'JB', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Tianjin Academy of TCM, Tianjin 300120, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20201104-0002']
2809,34762377,[Efficacy and action mechanism of  ZHU Lian  inhibition type Ⅰacupuncture for acne with spleen-stomach dampness-heat].,"OBJECTIVE


To observe the efficacy of  ZHU Lian  inhibition type Ⅰ acupuncture for acne with spleen-stomach dampness-heat, and to explore its possible action mechanism.
METHODS


A total of 82 patients of acne with spleen-stomach dampness-heat were randomly divided into an observation group and a control group, 41 cases in each group. The patients in the control group were treated with  danshentong  capsules (1 g, 3 times per day) and 0.1% adapalene gel smear (once every night) for 4 weeks. The patients in the observation group were treated with  ZHU Lian  inhibition type Ⅰ acupuncture at Hegu (LI 4), Neiting (ST 44), Quchi (LI 11), Yangbai (GB 14), Sibai (ST 2), Qihai (CV 6), Xuehai (SP 10), Yinlingquan (SP 9) and skin lesions, once every other day, 7 times as a course of treatment, totaling for 2 courses of treatment. The skin lesion score of the global acne grading system (GAGS) and quality of life-acne (Qol-Acne) score as well as the serum levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) were compared between the two groups before and after treatment; the clinical efficacy were compared between the two groups, and the recurrence rate was evaluated 4 weeks after treatment.
RESULTS


After treatment, the skin lesion scores of GAGS in the two groups were reduced ( P <0.05), and the score in the observation group was lower than that in the control group ( P <0.05). After treatment, the Qol-Acne scores were increased in the two groups ( P <0.05), and the score in the observation group was higher than that in the control group ( P <0.05). The serum levels of TNF-αand IL-6 in the two groups were reduced after treatment ( P <0.05), and those in the observation group were lower than the control group ( P <0.05). The total effective rate was 95.1% (39/41) in the observation group, which was higher than 82.9% (34/41) in the control group ( P <0.05). Four weeks after treatment, the recurrence rate of acne lesions was 10.3% (4/39) in the observation group, which was lower than 32.4% (11/34) in the control group ( P <0.05).
CONCLUSION


ZHU Lian  inhibition type Ⅰ acupuncture is effective for acne with spleen-stomach dampness-heat, and the recurrence rate is low. Its mechanism may be related to the reduction of serum inflammatory factor TNF-α and IL-6.",2021,"The serum levels of TNF-αand IL-6 in the two groups were reduced after treatment ( P <0.05), and those in the observation group were lower than the control group ( P <0.05).",['82 patients of acne with spleen-stomach dampness-heat'],"['ZHU Lian', 'ZHU Lian  inhibition type Ⅰ acupuncture', 'ZHU Lian  inhibition type Ⅰ acupuncture at Hegu (LI 4), Neiting (ST 44), Quchi (LI 11), Yangbai (GB 14), Sibai (ST 2), Qihai (CV 6), Xuehai (SP 10), Yinlingquan (SP 9) and skin lesions', 'inhibition type Ⅰ acupuncture', 'ZHU Lian  inhibition type Ⅰacupuncture', 'adapalene gel smear']","['skin lesion score of the global acne grading system (GAGS) and quality of life-acne (Qol-Acne) score', 'total effective rate', 'Qol-Acne scores', 'serum levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6', 'serum levels of TNF-αand IL-6', 'skin lesion scores of GAGS', 'clinical efficacy', 'recurrence rate of acne lesions', 'recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0018837', 'cui_str': 'Heat'}]","[{'cui': 'C0330941', 'cui_str': 'Melia azedarach'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C1252203', 'cui_str': 'adapalene Topical Gel'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}]","[{'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",82.0,0.0178542,"The serum levels of TNF-αand IL-6 in the two groups were reduced after treatment ( P <0.05), and those in the observation group were lower than the control group ( P <0.05).","[{'ForeName': 'Rui-Kang', 'Initials': 'RK', 'LastName': 'Pang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Guangxi University of CM, Nanning 530001, China.'}, {'ForeName': 'Yu-Shan', 'Initials': 'YS', 'LastName': 'Fan', 'Affiliation': ""Ren'ai Branch of First Affiliated Hospital, Guangxi University of CM.""}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Guangxi University of CM, Nanning 530001, China.'}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Zhao', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Guangxi University of CM, Nanning 530001, China.'}, {'ForeName': 'Li-Lin', 'Initials': 'LL', 'LastName': 'Huang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Guangxi University of CM, Nanning 530001, China.'}, {'ForeName': 'Fu-Rui', 'Initials': 'FR', 'LastName': 'Miao', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Guangxi University of CM, Nanning 530001, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20201007-k0002']
2810,34762376,"[Abdominal acupoint thread embedding therapy based on ""brain-intestinal connection"" for mild-to-moderate Alzheimer's disease and its effects on serum levels of APP and Aβ 1-42 ].","OBJECTIVE


To compare the clinical efficacy of abdominal acupoint thread embedding therapy based on ""brain-intestinal connection"" combined with donepezil hydrochloride tablets and oral donepezil hydrochloride tablets alone for mild-to-moderate Alzheimer's disease (AD) and observe its effects on amyloid precursor protein (APP) and β-amyloid protein 1-42  (Aβ 1-42 ).
METHODS


Sixty patients with AD were randomly divided into an observation group (30 cases, 3 cases dropped off) and a control group (30 cases, 3 cases dropped off). The patients in the control group were treated with donepezil hydrochloride tablets (5 mg per day); based on the treatment in the control group, the patients in the observation group were treated with abdominal acupoint thread embedding therapy at Zhongwan (CV 12), Xiawan (CV 10), Huaroumen (ST 24), Wailing (ST 26), Daheng (SP 15), etc., once every 10 days. Both groups were treated for 2 months. The mini-mental state examination (MMSE), Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog), activity of daily living scale (ADL), neuropsychiatric inventory questionnaire (NPI) as well as the serum levels of APP and Aβ 1-42  were observed before and after treatment in the two groups.
RESULTS


After treatment, the MMSE scores in the two groups were higher than those before treatment ( P <0.05), and the ADAS-Cog, ADL and NPI scores were lower than those before treatment ( P <0.05). After treatment, the MMSE score in the observation group was higher than that in the control group ( P <0.05), and the ADAS-Cog, ADL and NPI scores were lower than those in the control group ( P <0.05). After treatment, the serum levels of APP and Aβ 1-42  were lower than those before treatment ( P <0.05), and the serum levels of APP and Aβ 1-42  in the observation group was lower than those in the control group ( P <0.05).
CONCLUSION


The abdominal acupoint thread embedding therapy based on the theory of ""brain-intestinal connection"" combined with donepezil hydrochloride tablets can improve cognitive function, self-care ability of daily life and mental behavior, and reduce the serum levels of APP and Aβ 1-42  in patients with mild-to-moderate AD, which have superior clinical effect to donepezil hydrochloride tablets alone.",2021,"After treatment, the MMSE scores in the two groups were higher than those before treatment ( P <0.05), and the ADAS-Cog, ADL and NPI scores were lower than those before treatment ( P <0.05).","[""mild-to-moderate Alzheimer's disease (AD"", 'patients with mild-to-moderate AD', 'Sixty patients with AD']","['abdominal acupoint thread embedding therapy at Zhongwan (CV 12), Xiawan (CV 10), Huaroumen (ST 24), Wailing (ST 26), Daheng', 'donepezil hydrochloride tablets and oral donepezil hydrochloride tablets', 'donepezil hydrochloride tablets alone', 'abdominal acupoint thread embedding therapy', 'donepezil hydrochloride tablets', 'Abdominal acupoint thread embedding therapy based on ""brain-intestinal connection']","['MMSE scores', 'serum levels of APP and Aβ 1-42', 'serum levels of APP', 'cognitive function, self-care ability of daily life and mental behavior', 'ADAS-Cog, ADL and NPI scores', ""mini-mental state examination (MMSE), Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog), activity of daily living scale (ADL), neuropsychiatric inventory questionnaire (NPI) as well as the serum levels of APP and Aβ 1-42"", 'MMSE score']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0771848', 'cui_str': 'Donepezil hydrochloride'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0449379', 'cui_str': 'Connection'}]","[{'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085151', 'cui_str': 'Amyloid beta Precursor Protein'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform personal care activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}]",60.0,0.0344782,"After treatment, the MMSE scores in the two groups were higher than those before treatment ( P <0.05), and the ADAS-Cog, ADL and NPI scores were lower than those before treatment ( P <0.05).","[{'ForeName': 'Shu-Quan', 'Initials': 'SQ', 'LastName': 'Yang', 'Affiliation': 'Fifth Clinical Medical College of Guangzhou University of CM, Guangzhou 510095, Guangdong Province, China; Department of Acupuncture-Moxibustion, Second Hospital of TCM of Guangdong Province, Guangzhou 510095.'}, {'ForeName': 'De-Hui', 'Initials': 'DH', 'LastName': 'Fan', 'Affiliation': 'Department of Acupuncture-Moxibustion, Second Hospital of TCM of Guangdong Province, Guangzhou 510095.'}, {'ForeName': 'Zhi-Xian', 'Initials': 'ZX', 'LastName': 'Yuan', 'Affiliation': 'Department of Acupuncture-Moxibustion, Second Hospital of TCM of Guangdong Province, Guangzhou 510095.'}, {'ForeName': 'Mei-Yi', 'Initials': 'MY', 'LastName': 'Su', 'Affiliation': 'Department of Acupuncture-Moxibustion, Second Hospital of TCM of Guangdong Province, Guangzhou 510095.'}, {'ForeName': 'Zhen-Ning', 'Initials': 'ZN', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture-Moxibustion, Second Hospital of TCM of Guangdong Province, Guangzhou 510095.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Acupuncture-Moxibustion, Second Hospital of TCM of Guangdong Province, Guangzhou 510095.'}, {'ForeName': 'Hu-Guang', 'Initials': 'HG', 'LastName': 'Lin', 'Affiliation': 'Department of Acupuncture-Moxibustion, Second Hospital of TCM of Guangdong Province, Guangzhou 510095.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20201106-k0002']
2811,34762375,[ Xingnao   Kaiqiao  acupuncture on promoting wake-up of vegetative state after brain injury].,"OBJECTIVE


To observe the clinical effect of  Xingnao   Kaiqiao  acupuncture on promoting wake-up of vegetative state after brain injury on the basis of comprehensive rehabilitation training.
METHODS


A total of 100 patients with vegetative state after brain injury were randomly divided into an observation group (50 cases, 2 cases dropped off) and a control group (50 cases). Both groups were treated with routine clinical treatment. The patients in the control group were treated with rehabilitation and hyperbaric oxygen; on the basis of the control group treatment, the patients in the observation group were treated with  Xingnao   Kaiqiao  acupuncture at Neiguan (PC 6), Shuigou (GV 26), Sanyinjiao (SP 6), Chize (LU 5), Weizhong (BL 40), Hegu (LI 4) and Taichong (LR 3). The acupuncture was given once a day, 5 days per week, for continuous 30 days. The Glasgow coma scale (GCS) and coma recovery scale-revised (CRS-R) scores were observed before treatment and 10, 20 and 30 days into treatment. The wake-up rate of the two groups was compared after treatment.
RESULTS


On 10, 20 and 30 days into treatment, the GCS and CRS-R scores in the two groups were higher than those before treatment ( P <0.01), and the scores in the observation group were higher than those in the control group ( P <0.01). After treatment, the wake-up rate was 16.7% (8/48) in the observation group, which was higher than 12.0% (6/50) in the control group ( P <0.01).
CONCLUSION


On the basis of comprehensive rehabilitation and wake-up promotion therapy, the  Xingnao Kaiqiao  acupuncture could promote the recovery of consciousness level in patients with vegetative state after brain injury.",2021,"On 10, 20 and 30 days into treatment, the GCS and CRS-R scores in the two groups were higher than those before treatment ( P <0.01), and the scores in the observation group were higher than those in the control group ( P <0.01).","['100 patients with vegetative state after brain injury', 'patients with vegetative state after brain injury']","['Xingnao   Kaiqiao  acupuncture at Neiguan (PC 6), Shuigou (GV 26), Sanyinjiao (SP 6), Chize (LU 5), Weizhong (BL 40), Hegu (LI 4) and Taichong (LR 3', ' Xingnao   Kaiqiao  acupuncture', 'rehabilitation and hyperbaric oxygen', 'acupuncture', 'Xingnao   Kaiqiao  acupuncture']","['Glasgow coma scale (GCS) and coma recovery scale-revised (CRS-R) scores', 'GCS and CRS-R scores']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917808', 'cui_str': 'Vegetative State'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0626533', 'cui_str': 'SP 6'}, {'cui': 'C0450634', 'cui_str': 'BL40 - popliteal crease'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}]",100.0,0.0304821,"On 10, 20 and 30 days into treatment, the GCS and CRS-R scores in the two groups were higher than those before treatment ( P <0.01), and the scores in the observation group were higher than those in the control group ( P <0.01).","[{'ForeName': 'Ying-Cun', 'Initials': 'YC', 'LastName': 'Bao', 'Affiliation': 'Department of Rehabilitation Medicine, Second Hospital of Lanzhou University, Lanzhou 730030, Gansu Province, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Second Hospital of Lanzhou University, Lanzhou 730030, Gansu Province, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Second Hospital of Lanzhou University, Lanzhou 730030, Gansu Province, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Second Hospital of Lanzhou University, Lanzhou 730030, Gansu Province, China.'}, {'ForeName': 'Xiao-Rong', 'Initials': 'XR', 'LastName': 'Cheng', 'Affiliation': 'Department of Rehabilitation Medicine, Second Hospital of Lanzhou University, Lanzhou 730030, Gansu Province, China.'}, {'ForeName': 'Yi-Bao', 'Initials': 'YB', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Second Hospital of Lanzhou University, Lanzhou 730030, Gansu Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Qiu', 'Affiliation': 'Department of Rehabilitation Medicine, Second Hospital of Lanzhou University, Lanzhou 730030, Gansu Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20201101-k0002']
2812,34762374,[Clinical therapeutic effect on bronchial asthma by the observation of skin reaction after acupoint application based on chronic disease management platform of asthma].,"OBJECTIVE


To compare the therapeutic effect on bronchial asthma between presence of skin reaction and the absence of skin reaction after acupoint application.
METHODS


Sixty-one patients with bronchial asthma were treated with acupoint application during the hottest periods of summer (""dog days""). The acupoints included Dingchuan (EX-B 1), Feishu (BL 13), Xinshu (BL 15), Pishu (BL 20) and Shenshu (BL 23). The treatment was given once every 7 days, with the herbal plaster remained for 6 h each time, and 4 treatments were required totally. According to the local skin reaction after acupoint application, a skin reaction group (30 cases, 2 cases dropped off) and a non-skin reaction group (31 cases) were divided. Separately, before treatment and 1 year after treatment, using chronic disease management platform of asthma, the number of asthma attacks, the score of asthma control test (ACT) and the score of asthma quality of life questionnaire (AQLQ) were recorded online. Besides, the therapeutic effect was observed in the two groups 1 year after treatment.
RESULTS


One year after treatment, the number of asthma attacks was reduced as compared with that before treatment in the patients of either group ( P <0.001), the score of ACT and each domain in AQLQ, i.e. activity limitation, asthma symptoms, psychological state, reactions to stimuli and self-health care as well as the total scores of AQLQ were all increased as compared with those before treatment ( P <0.001). The number of asthma attacks in the skin reaction group was less than the non-skin reaction group ( P <0.05), the score of ACT and each domain of AQLQ and the total scores of AQLQ were all higher than the non-skin reaction group successively ( P <0.05,  P <0.01). The total effective rate was 82.1% (23/28) in the skin reaction group, better than 67.7% (21/31) in the non-skin reaction group ( P <0.05).
CONCLUSION


In treatment of acupoint application for bronchial asthma, the clinical therapeutic effect is better in the patients with local skin reaction after acupoint application. The chronic disease management platform of asthma is convenient for online evaluation.",2021,"The number of asthma attacks in the skin reaction group was less than the non-skin reaction group ( P <0.05), the score of ACT and each domain of AQLQ and the total scores of AQLQ were all higher than the non-skin reaction group successively ( P <0.05,  P <0.01).","['chronic disease management platform of asthma', 'patients with local skin reaction after acupoint application', 'Sixty-one patients with bronchial asthma']",['acupoint application'],"['total effective rate', 'score of ACT and each domain in AQLQ, i.e. activity limitation, asthma symptoms, psychological state, reactions to stimuli and self-health care', 'number of asthma attacks', 'total scores of AQLQ', 'score of ACT and each domain of AQLQ and the total scores of AQLQ', 'therapeutic effect', 'number of asthma attacks, the score of asthma control test (ACT) and the score of asthma quality of life questionnaire (AQLQ']","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0347950', 'cui_str': 'Acute exacerbation of asthma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",61.0,0.00770318,"The number of asthma attacks in the skin reaction group was less than the non-skin reaction group ( P <0.05), the score of ACT and each domain of AQLQ and the total scores of AQLQ were all higher than the non-skin reaction group successively ( P <0.05,  P <0.01).","[{'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, 4Department of Pharmacy, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, Jiangsu Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Key Laboratory of Acupuncture and Medicine Research of Ministry of Education, Nanjing University of Chinese Medicine.'}, {'ForeName': 'Wen-Zhong', 'Initials': 'WZ', 'LastName': 'Wu', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, 4Department of Pharmacy, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, Jiangsu Province, China.'}, {'ForeName': 'Xin-Xin', 'Initials': 'XX', 'LastName': 'Feng', 'Affiliation': 'Department of Acupuncture and Moxibustion, Ningbo Hospital of TCM.'}, {'ForeName': 'Ya-Wei', 'Initials': 'YW', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, Jiangsu Province, China.'}, {'ForeName': 'Han-Qing', 'Initials': 'HQ', 'LastName': 'Xi', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, 4Department of Pharmacy, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, Jiangsu Province, China.'}, {'ForeName': 'Cheng-Yong', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, 4Department of Pharmacy, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, Jiangsu Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20201030-k0001']
2813,34762373,[Effect of moxibustion on renal function and hypercoagulable state in patients with idiopathic membranous nephropathy of low to medium risk with spleen-kidney deficiency and blood stasis].,"OBJECTIVE


To compare the effect of moxibustion combined with basic treatment and simple basic treatment on the clinical symptoms, renal function and hypercoagulable state in patients with idiopathic membranous nephropathy (IMN) of low to medium risk with spleen-kidney deficiency and blood stasis.
METHODS


A total of 60 patients with IMN of low to medium risk with spleen-kidney deficiency and blood stasis were randomized into an observation group (30 cases, 2 cases dropped off) and a control group (30 cases, 1 case dropped off). In the control group, the conventional basic treatment of anti-hypertension, regulating blood lipid and anti-coagulation was adopted. On the basis of the control group, moxibustion was applied at Shenshu (BL 23), Pishu (BL 20), Guanyuan (CV 4), Zusanli (ST 36) and Sanyinjiao (SP 6) in the observation group, once a day, 5 days a week continuously with 2 day interval. The treatment of 6 months was required in the both groups. Before treatment and 3 and 6 months into treatment, the total TCM syndrome score, the renal function indexes (24-hour urinary protein quantity [UTP], albumin [ALB], urea nitrogen [BUN] and creatinine [Scr]), the blood coagulation indexes (fibrinogen [FIB], D-Dimer [D-D], p-selection and von Willebrand factor [vWF]), total cholesterol (TC) and triacylglycerol (TG) levels were observed, and the therapeutic efficacy was evaluated on 3 and 6 months into treatment in the two groups.
RESULTS


The effective rates of 3 and 6 months into treatment were 78.6% (22/28) and 89.3% (25/28) in the observation group, which were higher than 62.1% (18/29) and 75.9% (22/29) in the control group respectively ( P <0.05). On 3 and 6 months into treatment, the total TCM syndrome scores were decreased compared before treatment in the both groups ( P <0.05), and those in the observation group were lower than the control group ( P <0.05). On 3 months into treatment, the levels of UTP, FIB, D-D, P-selection and vWF were decreased ( P <0.05), the level of ALB was increased ( P <0.05) compared before treatment in the observation group; the levels of UTP and FIB were decreased compared before treatment in the control group ( P <0.05); the level of ALB in the observation group was higher than that in the control group ( P <0.05), the levels of FIB and vWF in the observation group were lower than those in the control group ( P <0.05). On 6 months into treatment, the levels of UTP, FIB, D-D, P-selection, vWF, TC and TG were decreased ( P <0.05), the levels of ALB were increased ( P <0.05) compared before treatment in the both groups ( P <0.05); the levels of UTP, FIB, D-D, P-selection, vWF, TC and TG in the observation group were lower than those in the control group, the level of ALB in the observation group was higher than that in the control group ( P <0.05).
CONCLUSION


Moxibustion combined with basic treatment can effectively improve the clinical symptoms, renal function and renal microcirculation in patients with idiopathic membranous nephropathy of low to medium risk with spleen-kidney deficiency and blood stasis, the therapeutic effect is superior to the simple basic treatment.",2021,"On 3 months into treatment, the levels of UTP, FIB, D-D, P-selection and vWF were decreased ( P <0.05), the level of ALB was increased ( P <0.05) compared before treatment in the observation group; the levels of UTP and FIB were decreased compared before treatment in the control group ( P <0.05); the level of ALB in the observation group was higher than that in the control group ( P <0.05), the levels of FIB and vWF in the observation group were lower than those in the control group ( P <0.05).","['patients with idiopathic membranous nephropathy of low to medium risk with spleen-kidney deficiency and blood stasis', 'patients with idiopathic membranous nephropathy', '60 patients with IMN of low to medium risk with spleen-kidney deficiency and blood stasis', 'patients with idiopathic membranous nephropathy (IMN) of low to medium risk with spleen-kidney deficiency and blood stasis']","['moxibustion', 'moxibustion combined with basic treatment and simple basic treatment']","['levels of UTP and FIB', 'renal function and hypercoagulable state', 'level of ALB', 'levels of UTP, FIB, D-D, P-selection, vWF, TC and TG', 'total TCM syndrome score, the renal function indexes (24-hour urinary protein quantity [UTP], albumin [ALB], urea nitrogen [BUN] and creatinine [Scr]), the blood coagulation indexes (fibrinogen [FIB], D-Dimer [D-D], p-selection and von Willebrand factor [vWF]), total cholesterol (TC) and triacylglycerol (TG) levels', 'clinical symptoms, renal function and renal microcirculation', 'levels of ALB', 'levels of UTP, FIB, D-D, P-selection and vWF', 'therapeutic efficacy', 'total TCM syndrome scores', 'levels of FIB and vWF', 'clinical symptoms, renal function and hypercoagulable state', 'effective rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086445', 'cui_str': 'Idiopathic membranous glomerulonephritis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0333138', 'cui_str': 'Stasis'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042010', 'cui_str': 'Uridine triphosphate'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0398623', 'cui_str': 'Thrombophilia'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0112081', 'cui_str': 'D-D mixture'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.0120268,"On 3 months into treatment, the levels of UTP, FIB, D-D, P-selection and vWF were decreased ( P <0.05), the level of ALB was increased ( P <0.05) compared before treatment in the observation group; the levels of UTP and FIB were decreased compared before treatment in the control group ( P <0.05); the level of ALB in the observation group was higher than that in the control group ( P <0.05), the levels of FIB and vWF in the observation group were lower than those in the control group ( P <0.05).","[{'ForeName': 'Jing-Yu', 'Initials': 'JY', 'LastName': 'Mao', 'Affiliation': 'Graduate School of Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Feng-Wen', 'Initials': 'FW', 'LastName': 'Yang', 'Affiliation': 'First Department of Nephrology, First Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Graduate School of Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Graduate School of Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Graduate School of Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Graduate School of Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, Fourth Hospital of Hebei Medical University.'}, {'ForeName': 'Su-Zhi', 'Initials': 'SZ', 'LastName': 'Chen', 'Affiliation': 'First Department of Nephrology, First Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011.'}, {'ForeName': 'Guo-Dong', 'Initials': 'GD', 'LastName': 'Yuan', 'Affiliation': 'First Department of Nephrology, First Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011.'}, {'ForeName': 'Mei-Jiao', 'Initials': 'MJ', 'LastName': 'Zhao', 'Affiliation': 'First Department of Nephrology, First Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011.'}, {'ForeName': 'Yi-Ran', 'Initials': 'YR', 'LastName': 'Kong', 'Affiliation': 'Graduate School of Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Jin-Chuan', 'Initials': 'JC', 'LastName': 'Tan', 'Affiliation': 'First Department of Nephrology, First Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200907-0005']
2814,34762372,[Therapeutic effect of electric-balance stimulation with scalp acupuncture for motor aphasia after cerebral infarction].,"OBJECTIVE


To compare the clinical efficacy between scalp acupuncture electrical stimulation and routine scalp acupuncture for motor aphasia in subacute stage of cerebral infarction.
METHODS


A total of 54 patients with motor aphasia in subacute stage of cerebral infarction were randomly divided into an observation group (27 cases, 1 case dropped off) and a control group (27 cases, 2 cases dropped off ). Both groups were treated with routine medication and language training. In the observation group, scalp acupuncture was given at bilateral lower 2/5 of the parietal and temporal anterior oblique line and temporal frontline; after the arrival of  qi , the electrical stimulation with disperse-dense wave was given at the affected side and continuous wave was given at healthy side. The control group was treated with routine scalp acupuncture at lower 2/5 of the parietal and temporal anterior oblique line and temporal frontline of the affected side, once a day, five times as a course, totaling two courses of treatment. The aphasia battery of Chinese (ABC) score and Boston diagnostic aphasia examination (BDAE) grade were observed before and after treatment. The levels of oxygenated hemoglobin (HbO 2 ), deoxyhemoglobin (D-Hb) and total hemoglobin (T-Hb) in local cerebral cortex of the two groups were measured in real time using functional near-infrared spectroscopy (fNIRS) before and after treatment. The clinical efficacy of the two groups was compared.
RESULTS


After treatment, the scores of listening comprehension, retelling, naming, spontaneous conversation and BDAE grade in the two groups were improved compared with those before treatment ( P <0.01,  P <0.05), and those in the observation group were better than the control group ( P <0.05). Compared before treatment, the levels of HbO 2  and T-Hb were increased ( P <0.01), and the levels of D-Hb were decreased ( P <0.01) after treatment in the two groups. The levels of HbO 2  and T-Hb in the observation group were higher than those in the control group ( P <0.05), and the level of D-Hb was lower than that in the control group ( P <0.05). The total effective rate was 92.3% (24/26) in the observation group, which was higher than 84.0% (21/25) in the control group ( P <0.05).
CONCLUSION


The scalp acupuncture electrical stimulation could improve cerebral circulation, activate specific functional areas of cerebral cortex, and promote the reconstruction and recovery of brain language function. Its curative effect is better than conventional scalp acupuncture.",2021,"Compared before treatment, the levels of HbO 2  and T-Hb were increased ( P <0.01), and the levels of D-Hb were decreased ( P <0.01) after treatment in the two groups.","['motor aphasia after cerebral infarction', '54 patients with motor aphasia in subacute stage of cerebral infarction']","['routine medication and language training', 'scalp acupuncture', 'electric-balance stimulation with scalp acupuncture', 'scalp acupuncture electrical stimulation', 'conventional scalp acupuncture', 'routine scalp acupuncture', 'scalp acupuncture electrical stimulation and routine scalp acupuncture']","['level of D-Hb', 'total effective rate', 'cerebral circulation, activate specific functional areas of cerebral cortex, and promote the reconstruction and recovery of brain language function', 'levels of D-Hb', 'scores of listening comprehension, retelling, naming, spontaneous conversation and BDAE grade', 'levels of oxygenated hemoglobin (HbO 2 ), deoxyhemoglobin (D-Hb) and total hemoglobin (T-Hb) in local cerebral cortex', 'clinical efficacy', 'levels of HbO 2  and T-Hb', 'aphasia battery of Chinese (ABC) score and Boston diagnostic aphasia examination (BDAE) grade']","[{'cui': 'C0003550', 'cui_str': 'Motor aphasia'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023018', 'cui_str': 'Language Training'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0007776', 'cui_str': 'Structure of cerebral cortex'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0057437', 'cui_str': 'Deoxyhemoglobin'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0451036', 'cui_str': 'Boston diagnostic aphasia examination'}]",54.0,0.0226809,"Compared before treatment, the levels of HbO 2  and T-Hb were increased ( P <0.01), and the levels of D-Hb were decreased ( P <0.01) after treatment in the two groups.","[{'ForeName': 'Xi-Qiang', 'Initials': 'XQ', 'LastName': 'Lou', 'Affiliation': 'Department of Acupuncture- Moxibustion, Lishui Hospital of TCM, Lishui 323000, Zhejiang Province, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture- Moxibustion, Lishui Hospital of TCM, Lishui 323000, Zhejiang Province, China.'}, {'ForeName': 'Chun-Hua', 'Initials': 'CH', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture- Moxibustion, Lishui Hospital of TCM, Lishui 323000, Zhejiang Province, China.'}, {'ForeName': 'Hua-Jian', 'Initials': 'HJ', 'LastName': 'Lin', 'Affiliation': 'Department of Acupuncture- Moxibustion, Lishui Hospital of TCM, Lishui 323000, Zhejiang Province, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture- Moxibustion, Lishui Hospital of TCM, Lishui 323000, Zhejiang Province, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'Department of Neurology, Lishui Hospital of TCM, Lishui 323000, Zhejiang Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20210302-k0005']
2815,34762351,A randomized controlled clinical trial on efficacy and safety of anakinra in patients with severe COVID-19.,"INTRODUCTION


Hyperinflammatory state has a role in the pathogenesis of COVID-19. Anakinra could reduce inflammation and help to combat the condition. In this study, we aimed to assess the safety and efficacy of anakinra (PerkinRA®) in severe COVID-19.
METHOD


The study was an open-label, randomized, controlled trial conducted in Imam Hossein Medical Center from May to July 2020. Patients with a confirmed diagnosis of COVID-19 were included in this study. We administered anakinra 100 mg daily intravenously. All patients received COVID-19 pharmacotherapy based on the represented national guideline. The need for invasive mechanical ventilation is considered the primary outcome.
RESULTS


Thirty patients were included in this study, and 15 of them received Anakinra. Nineteen patients were male (63.3%), and 11 were female (36.7%). The mean age of patients was 55.77 ± 15.89 years. In the intervention group, the need for invasive mechanical ventilation was significantly reduced compared to the control group (20.0% vs. 66.7%, p = .010). Also, these patients had a significantly lower length of hospital stay (p = .043). No significant higher rate of infection was recorded.
CONCLUSION


Anakinra as an immunomodulatory agent has been associated with the reduced need for mechanical ventilation in patients admitted to intensive care units because of severe COVID-19. The medication reduced the hospital length of stay. Furthermore, no increased risk of infection was observed. Further randomized placebo-controlled trials with a larger sample size are needed to confirm these findings.",2021,"In the intervention group, the need for invasive mechanical ventilation was significantly reduced compared to the control group (20.0% vs. 66.7%, p = .010).","['Patients with a confirmed diagnosis of COVID-19', 'Imam Hossein Medical Center from May to July 2020', 'Nineteen patients were male (63.3%), and 11 were female (36.7', 'patients admitted to intensive care units because of severe COVID-19', 'patients with severe COVID-19', 'The mean age of patients was 55.77\u2009±\u200915.89 years', 'Thirty patients were included in this study, and 15 of them received Anakinra']","['placebo', 'COVID-19 pharmacotherapy', 'anakinra (PerkinRA®']","['need for invasive mechanical ventilation', 'length of hospital stay', 'hospital length of stay', 'rate of infection', 'safety and efficacy', 'risk of infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",19.0,0.121401,"In the intervention group, the need for invasive mechanical ventilation was significantly reduced compared to the control group (20.0% vs. 66.7%, p = .010).","[{'ForeName': 'Amir Behnam', 'Initials': 'AB', 'LastName': 'Kharazmi', 'Affiliation': 'Department of Internal Medicine, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Moradi', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Haghighi', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Kouchek', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Manafi-Rasi', 'Affiliation': 'Department of Orthopedic Surgery, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Raoufi', 'Affiliation': 'Department of Radiology, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Simin Dokht', 'Initials': 'SD', 'LastName': 'Shoaei', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Hadavand', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Nabavi', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Iran.'}, {'ForeName': 'Mir Mohammad', 'Initials': 'MM', 'LastName': 'Miri', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Salarian', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedpouzhia', 'Initials': 'S', 'LastName': 'Shojaei', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Khalili', 'Affiliation': 'Department of Internal Medicine, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sistanizad', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Setayesh', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Karagah', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saemeh', 'Initials': 'S', 'LastName': 'Asgari', 'Affiliation': 'Medical Biotechnology Department, Biotechnology Research Center, Pasteur Institute of Iran, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Jaffaraghaei', 'Affiliation': 'PersisGen Par Company, Alborz, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Araghi', 'Affiliation': 'Department of Microbiology, Faculty of Advanced Science and Technology, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}]","Immunity, inflammation and disease",['10.1002/iid3.563']
2816,33905642,The Effects of Trazodone on Sleep Stability Among Patients With Temporomandibular Disorders: A Brief Report from an Interrupted Trial.,,2021,,['Patients With Temporomandibular Disorders'],['Trazodone'],['Sleep Stability'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0751243,,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Herrero Babiloni', 'Affiliation': ''}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Prie', 'Affiliation': ''}, {'ForeName': 'Cibele', 'Initials': 'C', 'LastName': 'Dal Fabbro', 'Affiliation': ''}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Harvey', 'Affiliation': ''}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Schmittbuhl', 'Affiliation': ''}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Desgroseilliers-Dussault', 'Affiliation': ''}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Beaudoin', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Mayer', 'Affiliation': ''}, {'ForeName': 'Gilles J', 'Initials': 'GJ', 'LastName': 'Lavigne', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001385']
2817,31990490,Indirect frontocingulate structural connectivity predicts clinical response to accelerated rTMS in major depressive disorder,"Background


Repetitive transcranial magnetic stimulation (rTMS) is an established treatment for major depressive disorder (MDD), but its clinical efficacy remains rather modest. One reason for this could be that the propagation of rTMS effects via structural connections from the stimulated area to deeper brain structures (such as the cingulate cortices) is suboptimal.
Methods


We investigated whether structural connectivity — derived from diffusion MRI data — could serve as a biomarker to predict treatment response. We hypothesized that stronger structural connections between the patient-specific stimulation position in the left dorsolateral prefrontal cortex (dlPFC) and the cingulate cortices would predict better clinical outcomes. We applied accelerated intermittent theta burst stimulation (aiTBS) to the left dlPFC in 40 patients with MDD. We correlated baseline structural connectivity, quantified using various metrics (fractional anisotropy, mean diffusivity, tract density, tract volume and number of tracts), with changes in depression severity scores
after aiTBS.
Results


Exploratory results (p < 0.05) showed that structural connectivity between the patient-specific stimulation site and the caudal and posterior parts of the cingulate cortex had predictive potential for clinical response to aiTBS.
Limitations


We used the diffusion tensor to perform tractography. A main limitation was that multiple fibre directions within voxels could not be resolved, which might have led to missing connections in some patients.
Conclusion


Stronger structural frontocingular connections may be of essence to optimally benefit from left dlPFC rTMS treatment in MDD. Even though the results are promising, further investigation with larger numbers of patients, more advanced tractography algorithms and classic daily rTMS treatment paradigms is warranted.
Clinical trial registration


http://clinicaltrials.gov/show/NCT01832805",2020,"Results


Exploratory results (p < 0.05) showed that structural connectivity between the patient-specific stimulation site and the caudal and posterior parts of the cingulate cortex had predictive potential for clinical response to aiTBS.
","['major depressive disorder (MDD', '40 patients with MDD', 'major depressive disorder']","['accelerated intermittent theta burst stimulation (aiTBS', 'accelerated rTMS', '\n\n\nRepetitive transcranial magnetic stimulation (rTMS']","['structural connectivity', 'baseline structural connectivity, quantified using various metrics (fractional anisotropy, mean diffusivity, tract density, tract volume and number of tracts']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",40.0,0.0496945,"Results


Exploratory results (p < 0.05) showed that structural connectivity between the patient-specific stimulation site and the caudal and posterior parts of the cingulate cortex had predictive potential for clinical response to aiTBS.
","[{'ForeName': 'Deborah C.W.', 'Initials': 'DC', 'LastName': 'Klooster', 'Affiliation': 'From the Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands (Klooster, Vos, Besseling, Aldenkamp); the Academic Center for Epileptology Kempenhaeghe, Department of Research and Development, Heeze, the Netherlands (Klooster, Aldenkamp); Ghent University, Ghent Experimental Psychiatry Laboratory, Ghent, Belgium (Baeken); the Australian Catholic University, Faculty of Health Sciences, Mary MacKillop Institute for Health Research, Melbourne, Australia (Caeyenberghs); the PROVIDI Lab, Image Sciences Institute, University Medical Center Utrecht and Utrecht University, Utrecht, the Netherlands (Leemans, David); the Brussel University Hospital, Department of Psychiatry, Brussels, Belgium (Baeken).'}, {'ForeName': 'Iris N.', 'Initials': 'IN', 'LastName': 'Vos', 'Affiliation': 'From the Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands (Klooster, Vos, Besseling, Aldenkamp); the Academic Center for Epileptology Kempenhaeghe, Department of Research and Development, Heeze, the Netherlands (Klooster, Aldenkamp); Ghent University, Ghent Experimental Psychiatry Laboratory, Ghent, Belgium (Baeken); the Australian Catholic University, Faculty of Health Sciences, Mary MacKillop Institute for Health Research, Melbourne, Australia (Caeyenberghs); the PROVIDI Lab, Image Sciences Institute, University Medical Center Utrecht and Utrecht University, Utrecht, the Netherlands (Leemans, David); the Brussel University Hospital, Department of Psychiatry, Brussels, Belgium (Baeken).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Caeyenberghs', 'Affiliation': 'From the Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands (Klooster, Vos, Besseling, Aldenkamp); the Academic Center for Epileptology Kempenhaeghe, Department of Research and Development, Heeze, the Netherlands (Klooster, Aldenkamp); Ghent University, Ghent Experimental Psychiatry Laboratory, Ghent, Belgium (Baeken); the Australian Catholic University, Faculty of Health Sciences, Mary MacKillop Institute for Health Research, Melbourne, Australia (Caeyenberghs); the PROVIDI Lab, Image Sciences Institute, University Medical Center Utrecht and Utrecht University, Utrecht, the Netherlands (Leemans, David); the Brussel University Hospital, Department of Psychiatry, Brussels, Belgium (Baeken).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Leemans', 'Affiliation': 'From the Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands (Klooster, Vos, Besseling, Aldenkamp); the Academic Center for Epileptology Kempenhaeghe, Department of Research and Development, Heeze, the Netherlands (Klooster, Aldenkamp); Ghent University, Ghent Experimental Psychiatry Laboratory, Ghent, Belgium (Baeken); the Australian Catholic University, Faculty of Health Sciences, Mary MacKillop Institute for Health Research, Melbourne, Australia (Caeyenberghs); the PROVIDI Lab, Image Sciences Institute, University Medical Center Utrecht and Utrecht University, Utrecht, the Netherlands (Leemans, David); the Brussel University Hospital, Department of Psychiatry, Brussels, Belgium (Baeken).'}, {'ForeName': 'Szabolcs', 'Initials': 'S', 'LastName': 'David', 'Affiliation': 'From the Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands (Klooster, Vos, Besseling, Aldenkamp); the Academic Center for Epileptology Kempenhaeghe, Department of Research and Development, Heeze, the Netherlands (Klooster, Aldenkamp); Ghent University, Ghent Experimental Psychiatry Laboratory, Ghent, Belgium (Baeken); the Australian Catholic University, Faculty of Health Sciences, Mary MacKillop Institute for Health Research, Melbourne, Australia (Caeyenberghs); the PROVIDI Lab, Image Sciences Institute, University Medical Center Utrecht and Utrecht University, Utrecht, the Netherlands (Leemans, David); the Brussel University Hospital, Department of Psychiatry, Brussels, Belgium (Baeken).'}, {'ForeName': 'René M.H.', 'Initials': 'RM', 'LastName': 'Besseling', 'Affiliation': 'From the Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands (Klooster, Vos, Besseling, Aldenkamp); the Academic Center for Epileptology Kempenhaeghe, Department of Research and Development, Heeze, the Netherlands (Klooster, Aldenkamp); Ghent University, Ghent Experimental Psychiatry Laboratory, Ghent, Belgium (Baeken); the Australian Catholic University, Faculty of Health Sciences, Mary MacKillop Institute for Health Research, Melbourne, Australia (Caeyenberghs); the PROVIDI Lab, Image Sciences Institute, University Medical Center Utrecht and Utrecht University, Utrecht, the Netherlands (Leemans, David); the Brussel University Hospital, Department of Psychiatry, Brussels, Belgium (Baeken).'}, {'ForeName': 'Albert P.', 'Initials': 'AP', 'LastName': 'Aldenkamp', 'Affiliation': 'From the Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands (Klooster, Vos, Besseling, Aldenkamp); the Academic Center for Epileptology Kempenhaeghe, Department of Research and Development, Heeze, the Netherlands (Klooster, Aldenkamp); Ghent University, Ghent Experimental Psychiatry Laboratory, Ghent, Belgium (Baeken); the Australian Catholic University, Faculty of Health Sciences, Mary MacKillop Institute for Health Research, Melbourne, Australia (Caeyenberghs); the PROVIDI Lab, Image Sciences Institute, University Medical Center Utrecht and Utrecht University, Utrecht, the Netherlands (Leemans, David); the Brussel University Hospital, Department of Psychiatry, Brussels, Belgium (Baeken).'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'From the Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands (Klooster, Vos, Besseling, Aldenkamp); the Academic Center for Epileptology Kempenhaeghe, Department of Research and Development, Heeze, the Netherlands (Klooster, Aldenkamp); Ghent University, Ghent Experimental Psychiatry Laboratory, Ghent, Belgium (Baeken); the Australian Catholic University, Faculty of Health Sciences, Mary MacKillop Institute for Health Research, Melbourne, Australia (Caeyenberghs); the PROVIDI Lab, Image Sciences Institute, University Medical Center Utrecht and Utrecht University, Utrecht, the Netherlands (Leemans, David); the Brussel University Hospital, Department of Psychiatry, Brussels, Belgium (Baeken).'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.190088']
2818,33340279,"Safety and nonclinical and clinical pharmacokinetics of PC945, a novel inhaled triazole antifungal agent.","PC945 is a novel antifungal triazole formulated for nebulized delivery to treat lung Aspergillus infections. Pharmacokinetic and safety profiles from nonclinical studies and clinical trials in healthy subjects, and subjects with mild asthma were characterized. Toxicokinetics were assessed following daily 2-hour inhalation for 14 days. Potential for drug-drug interactions was evaluated using pooled human liver microsomes. Clinical safety and pharmacokinetics were assessed following (a) single inhaled doses (0.5-10 mg), (b) 7-day repeat doses (5 mg daily) in healthy subjects; (c) a single dose (5 mg) in subjects with mild asthma. C max  occurred 4 hours (rats) or immediately (dogs) after a single dose. PC945 lung concentrations were substantially higher (>2000-fold) than those in plasma. PC945 only inhibited CYP3A4/5 substrate metabolism (IC 50  : 1.33 µM [testosterone] and 0.085 µM [midazolam]). Geometric mean C max  was 322 pg/mL (healthy subjects) and 335 pg/mL (subjects with mild asthma) 4-5 hours (median t max  ) after a single inhalation (5 mg). Following repeat, once daily inhalation (5 mg), Day 7 C max  was 951 pg/mL (0.0016 µM) 45 minutes after dosing. Increases in C max  and AUC 0-24h  were approximately dose-proportional (0.5-10 mg). PC945 administration was well tolerated in both healthy subjects and subjects with mild asthma. Treatment-emergent adverse events were mild/moderate and resolved before the study ended. No clinically significant lung function changes were observed. PC945 pharmacokinetics translated from nonclinical species to humans showed slow absorption from lungs and low systemic exposure, thereby limiting the potential for adverse side effects and drug interactions commonly seen with systemically delivered azoles.",2021,PC945 only inhibited CYP3A4/5 substrate metabolism (IC 50  : 1.33 µM [testosterone] and 0.085 µM [midazolam]).,"['healthy subjects, and subjects with mild asthma', 'subjects with mild asthma', 'healthy subjects', 'healthy subjects and subjects with mild asthma']","['PC945', 'µM [testosterone']","['Clinical safety and pharmacokinetics', 'Pharmacokinetic and safety profiles', 'PC945 lung concentrations', 'Toxicokinetics', 'CYP3A4/5 substrate metabolism']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282299', 'cui_str': 'Toxicokinetics'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0579503,PC945 only inhibited CYP3A4/5 substrate metabolism (IC 50  : 1.33 µM [testosterone] and 0.085 µM [midazolam]).,"[{'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Cass', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Murray', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Davis', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Woodward', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'Parexel Early Phase Clinical Unit Level 7, Northwick Park Hospital, Harrow, UK.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Strong', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ayrton', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Brindley', 'Affiliation': 'KinetAssist Limited, Quothquan, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Prosser', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'French', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Haywood', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wallis', 'Affiliation': 'Pulmocide Ltd, London, UK.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Rapeport', 'Affiliation': 'Pulmocide Ltd, London, UK.'}]",Pharmacology research & perspectives,['10.1002/prp2.690']
2819,33663316,Optimization of taste-masked dapoxetine oral thin films using factorial design:  in vitro  and  in vivo  evaluation.,"Dapoxetine HCl is used for the treatment of premature ejaculation. Dapoxetine is primarily metabolized in the liver and kidney and its metabolites are inactive; resulting in reduced bioavailability. Also, one of the commonly encountered issues in the oral dapoxetine formulae is its bitter taste. Thus, the objective of this study was to develop and to optimize novel dapoxetine taste-masked oral thin films (OTFs), to offer a faster dissolution rate, rapid release pattern, lower liver metabolism, and better patient compliance. To achieve our goal, the applicability of either pullulan or maltodextrin as strip forming polymers were investigated in the preparation of (OTFs), while glycerol was used as a plasticizer. Also, the physicochemical characteristics of dapoxetine in a resinate complex with AmberLite TM  -IRP69 as taste masking were evaluated. Furthermore, a 2 3  factorial design was used to study and to optimize the effect of the independent variables (strip forming polymer (X 1 ), glycerol (X 2 ) and AmberLite TM  (X 3 ) amounts) on the disintegration time (Y 1 ), degree of elongation (Y 2 ), and degree of  in vitro  drug release in phosphate buffer pH 6.8 at 5 minutes (Q5min, Y 3 ) as responses. P2 batch (OTF) (pullulan 96 mg, glycerol 12 mg, AmberLite TM  32 mg, and dapoxetine 30 mg) was identified as an optimized formulation showing an  in vitro  disintegration time 9.33 s, 35.56% elongation, and 91.43% Q5min; excellent  in vivo  disintegration time; good overall taste acceptability and stable resinate complex.",2021,"To achieve our goal, the applicability of either pullulan or maltodextrin as strip forming polymers were investigated in the preparation of (OTFs), while glycerol was used as a plasticizer.",['premature ejaculation'],"['Dapoxetine', 'dapoxetine taste-masked oral thin films (OTFs', 'pullulan 96\u2009mg, glycerol 12\u2009mg, AmberLite TM', 'pullulan or maltodextrin', 'Dapoxetine HCl']","['disintegration time (Y 1 ), degree of elongation (Y 2 ), and degree of  in\xa0vitro  drug release', 'P2 batch (OTF']","[{'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4553896', 'cui_str': 'Thin film'}, {'cui': 'C0072595', 'cui_str': 'pullulan'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0051547', 'cui_str': 'amberlite'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0970823', 'cui_str': 'Dapoxetine hydrochloride'}]","[{'cui': 'C1265875', 'cui_str': 'Disintegration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C3850077', 'cui_str': 'Drug Dissolution'}, {'cui': 'C2606970', 'cui_str': '1-butyl-3-methylimidazolium trifluoromethanesulfonate'}]",,0.0243792,"To achieve our goal, the applicability of either pullulan or maltodextrin as strip forming polymers were investigated in the preparation of (OTFs), while glycerol was used as a plasticizer.","[{'ForeName': 'Ibrahim A', 'Initials': 'IA', 'LastName': 'El-Said', 'Affiliation': 'Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Aboelwafa', 'Affiliation': 'Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Omaima N', 'Initials': 'ON', 'LastName': 'ElGazayerly', 'Affiliation': 'Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.'}]",Pharmaceutical development and technology,['10.1080/10837450.2021.1894445']
2820,34762555,Can Skin Temperature Be Altered After Different Magnitudes of Eccentric Exercise-Induced Muscle Damage?,"PURPOSE


This study aimed to assess skin temperature (Tsk) changes after different magnitudes of exercise-induced muscle damage (EIMD) of the elbow flexor muscles and investigate whether Tsk is related to indirect markers of EIMD.
METHODS


Thirty healthy active men were randomly allocated to the mild (MiDG) ( n  = 15) or moderate (MoDG) ( n  = 15) muscle damage group. Muscle damage in elbow flexor muscles was induced by 10 (for MiDG) or 30 (for MoDG) maximal eccentric isokinetic contractions at 60 degrees/s. Tsk, maximal voluntary isometric contraction (MVIC), delayed-onset muscle soreness (DOMS), plasma creatine kinase (CK) activity, range of motion (ROM), and pressure pain threshold (PPT) were measured before and up to 72 hr after EIMD.
RESULTS


Tsk increased only immediately after EIMD ( p  < .05;  f  = 1.44) in the MoDG (4.2%) and MiDG (4.6%), returning to near baseline values 30 min after EIMD and remaining so thereafter. In addition, there was no intergroup difference ( p  > .05) at any of the times analyzed, or correlation between Tsk and most indirect markers of EIMD.
CONCLUSIONS


In conclusion, Tsk should not be considered an indirect marker of mild or moderate muscle damage in active men, since alterations in this variable last less than 30 min after damaging exercise and showed no correlation with most indirect markers of EIMD.",2021,"RESULTS


Tsk increased only immediately after EIMD ( p  < .05;  f  = 1.44) in the MoDG (4.2%) and MiDG (4.6%), returning to near baseline values 30 min after EIMD and remaining so thereafter.",['Thirty healthy active men'],['mild (MiDG) ( n  =\xa015) or moderate (MoDG) ( n  =\xa015) muscle damage group'],"['Muscle damage in elbow flexor muscles', 'skin temperature (Tsk) changes', 'Tsk, maximal voluntary isometric contraction (MVIC), delayed-onset muscle soreness (DOMS), plasma creatine kinase (CK) activity, range of motion (ROM), and pressure pain threshold (PPT']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}]",30.0,0.0607533,"RESULTS


Tsk increased only immediately after EIMD ( p  < .05;  f  = 1.44) in the MoDG (4.2%) and MiDG (4.6%), returning to near baseline values 30 min after EIMD and remaining so thereafter.","[{'ForeName': 'Jean Artur Mendonça', 'Initials': 'JAM', 'LastName': 'Barboza', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'José Jamacy de Almeida', 'Initials': 'JJA', 'LastName': 'Ferreira', 'Affiliation': 'Federal University of Paraíba, Cidade Universitária.'}, {'ForeName': 'Mikhail Santos', 'Initials': 'MS', 'LastName': 'Cerqueira', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Daniel Germano', 'Initials': 'DG', 'LastName': 'Maciel', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Alef Cavalcanti Matias', 'Initials': 'ACM', 'LastName': 'de Barros', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Emmanoel Claudio', 'Initials': 'EC', 'LastName': 'Leite', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Monayane Grazielly', 'Initials': 'MG', 'LastName': 'Matias', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Telma Maria', 'Initials': 'TM', 'LastName': 'Lemos', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Rúsia Dayanny', 'Initials': 'RD', 'LastName': 'Nonato', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Wouber Hérickson', 'Initials': 'WH', 'LastName': 'de Brito Vieira', 'Affiliation': 'Federal University of Rio Grande do Norte.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2021.1909693']
2821,34762534,Laser-Assisted Drug Delivery of Tranexamic Acid by Picosecond Laser in Postinflammatory Hyperpigmentation: A Split-Area Double Blind Randomized Prospective Study.,"Background:  Tranexamic acid has been reported to benefit the treatment of postinflammatory hyperpigmentation (PIH). Laser-assisted drug delivery (LADD) could facilitate the efficacy of topically applied drugs into the dermis. This split-area randomized prospective study aims to assess whether early utilization of the LADD procedure with tranexamic acid delivery followed by picosecond lasers can attenuate the PIH better than the utilization of picosecond lasers alone.  Patients and methods:  Ten post-traumatic cases of PIH in 10 patients (8 female and 2 male) with an average age of 34.2 ± 11.2 years were included in this clinical trial. Using block randomization to determine the treatment side, one side of each area of the PIH was separated from the midline into two halves belonging to the control and tranexamic acid groups. The half area of the tranexamic acid group was further topically applied with 10% tranexamic acid solution. This procedure was repeated every 6 weeks, four times in total.  Results:  The self-assessment of the hyperpigmentation and overall satisfaction of the treatment outcome were not significantly different between the treatment and control sides.  Conclusions:  This split-area study revealed that, compared with picosecond alone, there was no significant difference adopting tranexamic acid in LADD after nonablative fractional picosecond laser for PIH.",2021,The self-assessment of the hyperpigmentation and overall satisfaction of the treatment outcome were not significantly different between the treatment and control sides.  ,"['10 patients (8 female and 2 male) with an average age of 34.2\u2009±\u200911.2 years', 'Postinflammatory Hyperpigmentation']","['Tranexamic acid', 'tranexamic acid', 'tranexamic acid solution', 'Laser-assisted drug delivery (LADD', 'Tranexamic Acid by Picosecond Laser']",['hyperpigmentation and overall satisfaction'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191359', 'cui_str': '34.2'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0265269', 'cui_str': 'Levy-Hollister syndrome'}, {'cui': 'C1532556', 'cui_str': 'Picosecond pulsed laser device'}]","[{'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",10.0,0.087657,The self-assessment of the hyperpigmentation and overall satisfaction of the treatment outcome were not significantly different between the treatment and control sides.  ,"[{'ForeName': 'Cen-Hung', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Plastic Surgery, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University and College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Yueh-Ju', 'Initials': 'YJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Plastic Surgery, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University and College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Ko-Chien', 'Initials': 'KC', 'LastName': 'Lin', 'Affiliation': 'Department of Plastic Surgery, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University and College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Mu-Han', 'Initials': 'MH', 'LastName': 'Hsieh', 'Affiliation': 'Department of Plastic Surgery, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University and College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Hui-Ping', 'Initials': 'HP', 'LastName': 'Lin', 'Affiliation': 'Department of Plastic Surgery, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University and College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Shiun-Yuan', 'Initials': 'SY', 'LastName': 'Hsu', 'Affiliation': 'Department of Trauma Surgery, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University and College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Hui-Hong', 'Initials': 'HH', 'LastName': 'Tsai', 'Affiliation': 'An Hsiang Dermatologic Clinic, Kaohsiung, Taiwan.'}, {'ForeName': 'Ching-Hua', 'Initials': 'CH', 'LastName': 'Hsieh', 'Affiliation': 'Department of Plastic Surgery, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University and College of Medicine, Kaohsiung, Taiwan.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2021.0086']
2822,34762533,An Efficacy of Photobiomodulation of 850 nm on Pain Reduction in a Human Oral Capsaicin Pain Model.,"Objective:  The aim of this clinical trial was to evaluate the efficacy of photobiomodulation (PBM) to reduce oral pain initiated by capsaicin. Background: PBM has been used for pain reduction in oral regions; however, its clinical efficacy to alleviate burning sensations is still unknown.  Methods:  This clinical study was divided into two phases. There were 10 subjects in each phase. In Phase I, the burning sensation was stimulated using 0.05% in 95% ethanol capsaicin (prepared by the Faculty of Pharmaceutical Sciences, Khon Kaen University, Thailand) on filter paper and recorded with a 10-cm horizontal visual analog scale (VAS) every 1 min until the subject experienced no more pain. The area under the curve (AUC) of the graph between VAS and time was calculated. The washout period was 24 h. In Phase II, a crossover clinical trial was conducted in subjects who received the pain model as stated. Four interventions were included: (1) PBM before & after pain stimulation, (2) PBM before pain stimulation, (3) PBM after pain stimulation, and (4) Placebo. For PBM intervention, a single exposure of 850 nm Laser (AsGaAl; TOP 250 Soft Laser, Berkmed Medikal, distributed by Medical Innovation-MI, Istanbul, Turkey) with 0.10 cm 2  spot size laser probe continuous wave at 1 W/cm 2  and 30 J/cm 2  for 30 sec was used.  Results:  In Phase I, there was no statistically significant difference ( p  = 0.09) between the average AUC of day 1 [55.63 (23.38)] and day 2 [48.99 (27.20)]. In phase II, there was no statistical difference ( p  = 0.20) of the average AUC among the interventions and the placebo; group 1 [56.24 (30.11)], group 2 [45.46 (45.46)], group 3 [64.15 (32.89)], and group 4 [58.59 (30.16)].  Conclusions:  The human capsaicin model was suitable for a crossover design clinical trial. The PBM used in this study did not reduce oral burning sensations from capsaicin.",2021,"In phase II, there was no statistical difference ( p  = 0.20) of the average AUC among the interventions and the placebo; group 1 [56.24 (30.11)], group 2 [45.46 (45.46)], group 3 [64.15 (32.89)], and group 4 [58.59 (30.16)].  ","['subjects who received the pain model as stated', '850\u2009nm on Pain Reduction in a Human Oral Capsaicin Pain Model']","['Placebo', 'ethanol capsaicin', 'photobiomodulation (PBM', 'capsaicin', 'placebo']","['burning sensation', 'oral burning sensations']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0065764', 'cui_str': 'MBD protocol'}]","[{'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",,0.11024,"In phase II, there was no statistical difference ( p  = 0.20) of the average AUC among the interventions and the placebo; group 1 [56.24 (30.11)], group 2 [45.46 (45.46)], group 3 [64.15 (32.89)], and group 4 [58.59 (30.16)].  ","[{'ForeName': 'Sajee', 'Initials': 'S', 'LastName': 'Sattayut', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Duangruthai', 'Initials': 'D', 'LastName': 'Chotiwutthiphatthana', 'Affiliation': 'Lasers in Dentistry Research Group, Faculty of Dentistry, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Todsaphon', 'Initials': 'T', 'LastName': 'Inprakhon', 'Affiliation': 'Lasers in Dentistry Research Group, Faculty of Dentistry, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Tiansongjai', 'Affiliation': 'Lasers in Dentistry Research Group, Faculty of Dentistry, Khon Kaen University, Khon Kaen, Thailand.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2020.4892']
2823,34762532,Clinical Evaluation of 532-nm Green Laser on Dentin Hypersensitivity: A Randomized Double-Blind Clinical Trial.,"Objective:  The aim of this study was to evaluate the therapies of low-level green laser and chemical desensitizer in the treatment of dentin hypersensitivity (DH).  Methods:  Forty-eight patients with 96 sensitive teeth were invited to participate in this clinical trial and were randomly divided into three groups. One group was treated with low-level green laser, the second group was treated with desensitizer [sodium fluoride (NaF)], and the third group acted as the placebo group and was treated with distilled water and placebo laser. The wavelength of green laser was 532 nm and the irradiance was 15 J/cm 2  per treatment site. Hypersensitivity was assessed by visual analogue scale (VAS) according to cold test and probing at baseline. Immediately, 2 weeks, and 3 months after the application of green laser, NaF, and placebo, the participants' sensitivity level was accessed by new VAS analysis.  Results:  Forty-five patients with 90 teeth ( n  = 15 patients/group; 30 teeth/group) were followed up for 2 weeks and 3 months after treatment. There were significant differences in VAS scores between the placebo group and intervention group (green laser group and NaF group; analysis of variance,  p  < 0.05) at all three time points. The mean pain scores in DH reduced significantly immediately after treatment in the green laser group and NaF group when stimulated by cold and probing, whereas no significant difference was observed with these two therapies after 2 weeks ( p  > 0.05). After 3 months, mean VAS scores of the NaF group were higher than those of the green laser group ( p  < 0.01).  Conclusions:  Therefore, the green laser displayed similar effectiveness as NaF in treatment of DH and could be a promising new therapy to reduce DH.",2021,"The mean pain scores in DH reduced significantly immediately after treatment in the green laser group and NaF group when stimulated by cold and probing, whereas no significant difference was observed with these two therapies after 2 weeks ( p  > 0.05).","['Forty-five patients with 90 teeth ( n \u2009=\u200915 patients/group; 30 teeth/group', 'Dentin Hypersensitivity', 'dentin hypersensitivity (DH', 'Methods:  Forty-eight patients with 96 sensitive teeth']","['532-nm Green Laser', 'green laser, NaF, and placebo', 'low-level green laser and chemical desensitizer', 'placebo', 'desensitizer [sodium fluoride (NaF', 'low-level green laser', 'distilled water and placebo laser']","['Hypersensitivity', 'visual analogue scale (VAS', 'mean VAS scores', 'wavelength of green laser', 'mean pain scores in DH', 'VAS scores']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C1289896', 'cui_str': 'Laser light, green'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C1289896', 'cui_str': 'Laser light, green'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",48.0,0.0785038,"The mean pain scores in DH reduced significantly immediately after treatment in the green laser group and NaF group when stimulated by cold and probing, whereas no significant difference was observed with these two therapies after 2 weeks ( p  > 0.05).","[{'ForeName': 'Su-Ning', 'Initials': 'SN', 'LastName': 'Hu', 'Affiliation': 'Department of Prosthodontics, Peking University School, Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Lin-Tian', 'Initials': 'LT', 'LastName': 'Yuan', 'Affiliation': 'Department of Prosthodontics, Peking University School, Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Meng-Qi', 'Initials': 'MQ', 'LastName': 'Wang', 'Affiliation': 'National Engineering Laboratory for Digital and Material Technology of Stomatology, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Yu-Guang', 'Initials': 'YG', 'LastName': 'Wang', 'Affiliation': 'Department of Prosthodontics, Peking University School, Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Yong-Sheng', 'Initials': 'YS', 'LastName': 'Zhou', 'Affiliation': 'Department of Prosthodontics, Peking University School, Hospital of Stomatology, Beijing, China.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2021.0046']
2824,34762528,Endothelin Receptor Blockade Blunts the Pressor Response to Acute Stress in Obese Men and Women.,"Obesity is associated with dysregulation of the endothelin system. In obese individuals, an exaggerated pressor response to acute stress is accompanied by increased circulating endothelin-1. The impact of combined endothelin A/B receptor (ET A/B ) antagonism on the stress-induced pressor response in overweight/obese individuals is unknown.
OBJECTIVE


To test the hypothesis that treatment with an ET A/B  antagonist (bosentan) would reduce the stress-induced pressor response and arterial stiffness in overweight/obese compared to normal weight individuals.
METHODS


40 participants [Normal weight (NW): n=20, BMI: 21.7 ± 2.4 kg/m 2  & Overweight/obese (OB): n=20, BMI: 33.8 ± 8.2 kg/m 2 ] were randomized to placebo or 125 mg of bosentan twice a day (250 mg total) for 3 days. Hemodynamics were assessed before, during, and after a cold pressor test (CPT). Endothelin-1 was assessed at baseline and immediately after CPT. Following a washout period, the same protocol was repeated with the opposite treatment.
RESULTS


The change from baseline in mean arterial pressure (MAP) during CPT following bosentan was significantly lower (p=0.039) in the OB group, compared to the NW group (OB: 28±12 vs LN: 34±15 mm Hg).
CONCLUSIONS


These results suggest that ET A/B  antagonism favorably blunts the pressor response to acute stress in overweight/obese individuals.",2021,"The change from baseline in mean arterial pressure (MAP) during CPT following bosentan was significantly lower (p=0.039) in the OB group, compared to the NW group (OB: 28±12 vs LN: 34±15 mm Hg).
","['overweight/obese individuals', '40 participants [Normal weight (NW): n=20, BMI: 21.7 ± 2.4 kg/m 2  & Overweight/obese (OB): n=20, BMI: 33.8 ± 8.2 kg/m 2 ', 'Obese Men and Women']","['Endothelin Receptor Blockade', 'placebo', 'combined endothelin A/B receptor (ET A/B ) antagonism']","['Endothelin-1', 'mean arterial pressure (MAP']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5191366', 'cui_str': '21.7'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0059285', 'cui_str': 'Endothelin Receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079284', 'cui_str': 'Endothelin'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",40.0,0.0788073,"The change from baseline in mean arterial pressure (MAP) during CPT following bosentan was significantly lower (p=0.039) in the OB group, compared to the NW group (OB: 28±12 vs LN: 34±15 mm Hg).
","[{'ForeName': 'Cassandra C', 'Initials': 'CC', 'LastName': 'Derella', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Anson M', 'Initials': 'AM', 'LastName': 'Blanks', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Tucker', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Chase', 'Initials': 'C', 'LastName': 'Horsager', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rodriguez-Miguelez', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Looney', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pollock', 'Affiliation': 'Cardio-Renal Physiology and Medicine Section, Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Augusta University, Augusta, GA, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00156.2021']
2825,34762527,Post-exercise urinary alpha-1 acid glycoprotein is not dependent on hypoxia.,"INTRODUCTION


Proteinuria is a transient physiologic phenomenon that occurs with a range of physical activities and during ascent to altitude. Exercise intensity appears to dictate the magnitude of post-exercise proteinuria; however, evidence also indicates possible contributions from exercise-induced hypoxemia or reoxygenation. Utilizing an environmental hypoxic chamber, this crossover designed study aimed to evaluate urinary alpha-1 acid glycoprotein (α1-AGP) excretion pre/post exercise performed in hypoxia and normoxia.
METHODS


Sixteen individuals underwent experimental sessions in normoxia (NOR, 20.9% O 2 ) and hypoxia (HYP, 12.0% O 2 ). Sessions began with a 2-hour priming period before completing a graded maximal exercise test (GXT) on a cycle ergometer, which was followed by continuation of exposure for an additional 2 hours. Physiologic responses (i.e., blood pressure, heart rate, and peripheral oxygenation), Lake Louise Scores, and urine specimens (analyzed for albumin and α1-AGP) were collected pre- and post-exercise (after 30, 60, and 120 minutes).
RESULTS


Peak power output was significantly reduced in HYP (193 ± 45 W) compared to NOR (249 ± 59 W, p < 0.01). Post-exercise urinary α1-AGP was greater in NOR (20.04 ± 14.84 μg•min -1 ) compared to HYP (15.08 ± 13.46 μg•min -1 ), albeit the difference was not significant (p > 0.05). Changes in urinary α1-AGP from pre- to post-30 minutes were not related to physiologic responses or performance outcomes observed during GXT in NOR or HYP.
CONCLUSION


Despite profound systemic hypoxemia with maximal exercise in hypoxia, post-exercise α1-AGP excretion was not elevated above levels observed following normoxic exercise.",2021,"Changes in urinary α1-AGP from pre- to post-30 minutes were not related to physiologic responses or performance outcomes observed during GXT in NOR or HYP.
CONCLUSION


Despite profound systemic hypoxemia with maximal exercise in hypoxia, post-exercise α1-AGP excretion was not elevated above levels observed following normoxic exercise.","['Sixteen individuals underwent experimental sessions in normoxia (NOR, 20.9% O 2 ) and hypoxia (HYP, 12.0% O 2 ']","['graded maximal exercise test (GXT', 'urinary alpha-1 acid glycoprotein (α1-AGP) excretion pre/post exercise']","['Peak power output', 'Post-exercise urinary α1-AGP', 'Physiologic responses (i.e., blood pressure, heart rate, and peripheral oxygenation), Lake Louise Scores, and urine specimens (analyzed for albumin and α1-AGP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0733682', 'cui_str': 'Hypophosphatemic Rickets, X-Linked Dominant'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0029297', 'cui_str': 'Alpha-1- acid glycoprotein'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0029297', 'cui_str': 'Alpha-1- acid glycoprotein'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]",16.0,0.0176518,"Changes in urinary α1-AGP from pre- to post-30 minutes were not related to physiologic responses or performance outcomes observed during GXT in NOR or HYP.
CONCLUSION


Despite profound systemic hypoxemia with maximal exercise in hypoxia, post-exercise α1-AGP excretion was not elevated above levels observed following normoxic exercise.","[{'ForeName': 'Kelsey Elizabeth', 'Initials': 'KE', 'LastName': 'Joyce', 'Affiliation': 'School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Balanos', 'Affiliation': 'School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bradley', 'Affiliation': 'School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fountain', 'Affiliation': 'Research & Development, The Binding Site Ltd, Birmingham, United Kingdom.'}, {'ForeName': 'Arthur Randell', 'Initials': 'AR', 'LastName': 'Bradwell', 'Affiliation': 'The Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Samuel J E', 'Initials': 'SJE', 'LastName': 'Lucas', 'Affiliation': 'School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00476.2021']
2826,34762850,Is Inferior Alveolar Nerve Block Needed to Perform Implant Surgery in the Posterior Mandible? A Randomized Controlled Trial.,"PURPOSE


There is no agreement in the literature on whether inferior alveolar nerve block (IANB) or infiltration (INF) is the anesthetic technique of choice for placing implants in the posterior mandible. This study aimed to compare the efficacy of the 2 techniques using articaine 4% with epinephrine 1:100,000.
MATERIAL AND METHODS


The trial was a comparison between 2 parallel groups of patients, who received implants distal to the mental foramen, either with IANB or INF. The anesthetic technique was the predictor variable. The primary outcome was patients' perceived pain by a numerical rating scale (NRS) in incision, osteotomy and suture. The secondary outcome, patients' satisfaction, was equally recorded 12 hours after surgery. The dataset were first analyzed by descriptive statistics. Then, Mann-Whitney test, Spearman's coefficient and regression models were used. This trial followed the recommendations of the Consort Statement for reporting RCTs.
RESULTS


Ninety-six patients (41 men, 55 women, mean age 55.76 years) were randomly assigned to either group, IANB or INF, of 48 patients each. Only 20% of patients reported pain values >0 (range 0-4 of 10). Medians were: 0 (0-0) for both groups (P = .956, .175 and .908, incision, osteotomy and suture, respectively). Mean satisfaction was high in both groups, 9.0 ± 1.0, median 10; and 8.8 ± 1.7, median 9, for IANB and INF (P = .695). Hence, the anesthetic technique did not generate statistically significant differences. Five potential influencing variables that were measured did not significantly affect pain levels or patient satisfaction in either group.
CONCLUSIONS


According to the results, an IANB might not be necessary for standard implant surgery in the posterior mandible, and infiltration of articaine 4% with epinephrine 1:100,000 appears to be sufficient. Further research is needed to check if these results are extensible to other anesthetic drugs.",2021,"Medians were: 0 (0-0) for both groups (P = .956, .175 and .908, incision, osteotomy and suture, respectively).","['Ninety-six patients (41 men, 55 women, mean age 55.76 years', '2 parallel groups of patients, who received implants distal to the mental foramen, either with IANB or INF']","['epinephrine', 'articaine']","['pain levels or patient satisfaction', 'pain by a numerical rating scale (NRS) in incision, osteotomy and suture', 'pain values', 'inferior alveolar nerve block (IANB) or infiltration (INF', 'Mean satisfaction']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0448011', 'cui_str': 'Mental foramen'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",96.0,0.117336,"Medians were: 0 (0-0) for both groups (P = .956, .175 and .908, incision, osteotomy and suture, respectively).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Esteve-Pardo', 'Affiliation': 'Private Practice, Master Degree in Biotechnology and Bioengineering in Bioengineering Institute, Miguel Hernández University of Elche, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'De-Larriva', 'Affiliation': 'Private practice at Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salgado', 'Affiliation': 'Private Practice, Teaching Assistant, Miguel Hernández University of Elche, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bernabeu-Esclapez', 'Affiliation': 'Private practice, Elche, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Bardaji', 'Affiliation': 'Private practice, Assistant Professor, Periodontology & Osseointegration Department, Universidad Católica, Valencia, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Esteve-Colomina', 'Affiliation': 'Private Practice, Master Degree in Biotechnology and Bioengineering in Bioengineering Institute, Miguel Hernández University of Elche, Spain. Electronic address: guillemjoes@hotmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2021.09.028']
2827,34762845,Multicomponent Staff Training Intervention to Improve Residential Dementia Care (PROCUIDA-Demencia): A Mixed-Methods 2-Arm Cluster Randomized Controlled Pilot and Clinical Outcomes Study.,"OBJECTIVES


To evaluate the feasibility outcomes of implementing a multicomponent staff training intervention (PROCUIDA-Demencia) to promote psychosocial interventions and reduce antipsychotic prescription in Mexican care homes and study its effect on staff's care experience and residents' quality of life.
DESIGN


A mixed-methods 2-arm cluster randomized controlled pilot study of a 2-day staff training program with baseline, 12 weeks, and 24 weeks of the PROCUIDA-Demencia intervention vs treatment as usual (TAU).
SETTING AND PARTICIPANTS


Eight care homes in Mexico City were selected, from which 55 residents and 126 staff were recruited.
INTERVENTION


In situ staff training consisting of evidence-based manualized psychosocial interventions of person-centered activities, reminiscence therapy, doll therapy, psychomotor dance therapy, and antipsychotic prescription review. Fidelity to protocol was supervised once a week.
METHODS


Cluster-level feasibility measures included views of staff, residents, and relatives on acceptability, satisfaction, adherence, and fidelity to the intervention. Staff outcome measures were Maslach Burnout Inventory (MBI), Approaches to Dementia Questionnaire, and Sense of Competence in Dementia Care Staff. Residents' outcome measures included Quality of Life-Alzheimer's Disease scale (QoL-AD), and Neuropsychiatric Inventory-Nursing Home Version (NPI-NH). Staff distress was measured using the NPI-NH occupational disturbance scale. Feasibility was elicited through a focus group, and hierarchical linear mixed effects models were used to assess the adjusted effects of the respective measures.
RESULTS


Observed medical practice showed the prescription of at least 1 antipsychotic in 41% of participants in the intervention group. Overall, 39% of residents reported discontinuation, and 15% reduction of antipsychotics, following the 12-week medical review in parallel with psychosocial interventions. Clinical outcomes contributed positively to the reduction in baseline staff burden according to the MBI after the intervention [mean difference -8.9, 95% confidence interval (CI) -17.7, -0.1, P = .049] and to the reduction in severity and frequency of behavior as per NPI-NH in residents (mean difference -9.4, 95% CI -17.5, -1.3, P = .025).
CONCLUSIONS AND IMPLICATIONS


PROCUIDA-Demencia is a feasible intervention for Mexican care homes. Results contribute to the Mexican Dementia Plan optimizing dementia care by supporting the need for staff training to implement psychosocial interventions prior to prescribing antipsychotic medication.",2021,"Overall, 39% of residents reported discontinuation, and 15% reduction of antipsychotics, following the 12-week medical review in parallel with psychosocial interventions.","['Residential Dementia Care (PROCUIDA-Demencia', 'Eight care homes in Mexico City were selected, from which 55 residents and 126 staff were recruited', 'Mexican care homes']","['Multicomponent Staff Training Intervention', 'multicomponent staff training intervention']","[""Quality of Life-Alzheimer's Disease scale (QoL-AD), and Neuropsychiatric Inventory-Nursing Home Version (NPI-NH"", 'Maslach Burnout Inventory (MBI), Approaches to Dementia Questionnaire, and Sense of Competence in Dementia Care Staff', 'severity and frequency of behavior', 'NPI-NH occupational disturbance scale', 'Staff distress', 'acceptability, satisfaction, adherence, and fidelity to the intervention']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0790856,"Overall, 39% of residents reported discontinuation, and 15% reduction of antipsychotics, following the 12-week medical review in parallel with psychosocial interventions.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Torres-Castro', 'Affiliation': 'Instituto Nacional de Geriatría, San Jerónimo Lídice, Mexico City, Mexico. Electronic address: storres@inger.gob.mx.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Rabaneda-Bueno', 'Affiliation': 'Biology Centre of the Czech Academy of Sciences, Institute of Hydrobiology, České Budějovice, Czech Republic.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'López-Ortega', 'Affiliation': 'Instituto Nacional de Geriatría, San Jerónimo Lídice, Mexico City, Mexico.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Gutiérrez-Robledo', 'Affiliation': 'Instituto Nacional de Geriatría, San Jerónimo Lídice, Mexico City, Mexico.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'Guzmán', 'Affiliation': 'Department of Clinical Psychology, School of Health in Social Science, University of Edinburgh, Edinburgh, United Kingdom; Adult Mental Health Team Psychological Services, NHS Lothian, Royal Edinburgh Hospital, Edinburgh, United Kingdom.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.09.035']
2828,34762840,Pharmacogenetic studies of long-acting beta agonist and inhaled corticosteroid responsiveness in randomised controlled trials of individuals of African descent with asthma.,"BACKGROUND


Pharmacogenetic studies in asthma cohorts, primarily made up of White people of European descent, have identified loci associated with response to inhaled beta agonists and corticosteroids (ICSs). Differences exist in how individuals from different ancestral backgrounds respond to long-acting beta agonist (LABA) and ICSs. Therefore, we sought to understand the pharmacogenetic mechanisms regulating therapeutic responsiveness in individuals of African descent.
METHODS


We did ancestry-based pharmacogenetic studies of children (aged 5-11 years) and adolescents and adults (aged 12-69 years) from the Best African Response to Drug (BARD) trials, in which participants with asthma uncontrolled with low-dose ICS (fluticasone propionate 50 μg in children, 100 μg in adolescents and adults) received different step-up combination therapies. The hierarchal composite outcome of pairwise superior responsiveness in BARD was based on asthma exacerbations, a 31-day difference in annualised asthma-control days, or a 5% difference in percentage predicted FEV 1 . We did whole-genome admixture mapping of 15 159 ancestral segments within 312 independent regions, stratified by the two age groups. The two co-primary outcome comparisons were the step up from low-dose ICS to the quintuple dose of ICS (5 × ICS: 250 μg twice daily in children and 500 μg twice daily in adolescents and adults) versus double dose (2-2·5 × ICS: 100 μg twice daily in children, 250 μg twice daily in adolescents and adults), and 5 × ICS versus 100 μg fluticasone plus a LABA (salmeterol 50 μg twice daily). We used a genome-wide significance threshold of p<1·6 × 10 -4 , and tested for replication using independent cohorts of individuals of African descent with asthma.
FINDINGS


We included 249 unrelated children and 267 unrelated adolescents and adults in the BARD pharmacogenetic analysis. In children, we identified a significant admixture mapping peak for superior responsiveness to 5 × ICS versus 100 μg fluticasone plus salmeterol on chromosome 12 (odds ratio [OR local African ] 3·95, 95% CI 2·02-7·72, p=6·1 × 10 -5 ) fine mapped to a locus adjacent to RNFT2 and NOS1 (rs73399224, OR allele dose  0·17, 95% CI 0·07-0·42, p=8·4 × 10 -5 ). In adolescents and adults, we identified a peak for superior responsiveness to 5 × ICS versus 2·5 × ICS on chromosome 22 (OR local African  3·35, 1·98-5·67, p=6·8 × 10 -6 ) containing a locus adjacent to TPST2 (rs5752429, OR allele dose  0·21, 0·09-0·52, p=5·7 × 10 -4 ). We replicated rs5752429 and nominally replicated rs73399224 in independent African American cohorts.
INTERPRETATION


BARD is the first genome-wide pharmacogenetic study of LABA and ICS response in clinical trials of individuals of African descent to detect and replicate genome-wide significant loci. Admixture mapping of the composite BARD trial outcome enabled the identification of novel pharmacogenetic variation accounting for differential therapeutic responses in people of African descent with asthma.
FUNDING


National Institutes of Health, National Heart, Lung, and Blood Institute.",2021,"In children, we identified a significant admixture mapping peak for superior responsiveness to 5 × ICS versus 100 μg fluticasone plus salmeterol on chromosome 12 (odds ratio [OR local African ]","['individuals of African descent', '50 μg in children, 100 μg in adolescents and adults', 'individuals of African descent with asthma', '15\u2008159 ancestral segments within 312 independent regions, stratified by the two age groups', '249 unrelated children and 267 unrelated adolescents and adults in the BARD pharmacogenetic analysis', 'African American cohorts', 'people of African descent with asthma', '100 μg twice daily in children, 250 μg twice daily in adolescents and adults', 'children (aged 5-11 years) and adolescents and adults (aged 12-69 years) from the Best African Response to Drug (BARD) trials, in which participants with asthma uncontrolled with low-dose']","['double dose (2-2·5\u2008×\u2008ICS', 'ICS (fluticasone propionate', 'fluticasone plus a LABA ', 'fluticasone plus salmeterol', 'different step-up combination therapies', 'salmeterol']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4084975', 'cui_str': 'Pharmacogenetic Study'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]",[],249.0,0.45131,"In children, we identified a significant admixture mapping peak for superior responsiveness to 5 × ICS versus 100 μg fluticasone plus salmeterol on chromosome 12 (odds ratio [OR local African ]","[{'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Ortega', 'Affiliation': 'Department of Internal Medicine, Section for Pulmonary, Critical Care, Allergy, and Immunologic Diseases, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: ortega.victor@mayo.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Daya', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'Department of Internal Medicine, Division of Genetics, Genomics, and Precision Medicine, University of Arizona College of Medicine, Tucson, AZ, USA.'}, {'ForeName': 'Vernon M', 'Initials': 'VM', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Pediatric Allergy and Immunology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Mauger', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Fernando D', 'Initials': 'FD', 'LastName': 'Martinez', 'Affiliation': 'Asthma and Airway Disease Research Center, University of Arizona Health Sciences, Tucson, AZ, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Herrera-Luis', 'Affiliation': 'Department of Biochemistry, La Laguna, Tenerife, Spain; Microbiology, Cell Biology, and Genetics, La Laguna, Tenerife, Spain; Genomics and Health Group, La Laguna, Tenerife, Spain; Universidad de La Laguna, La Laguna, Tenerife, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pino-Yanes', 'Affiliation': 'Department of Biochemistry, La Laguna, Tenerife, Spain; Microbiology, Cell Biology, and Genetics, La Laguna, Tenerife, Spain; Genomics and Health Group, La Laguna, Tenerife, Spain; Universidad de La Laguna, La Laguna, Tenerife, Spain; CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Hawkins', 'Affiliation': 'Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Ampleford', 'Affiliation': 'Department of Internal Medicine, Section for Pulmonary, Critical Care, Allergy, and Immunologic Diseases, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Kunselman', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Cabana', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': 'Department of Internal Medicine, Division of Allergy and Immunology, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Loren C', 'Initials': 'LC', 'LastName': 'Denlinger', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Eng', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Pediatrics, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}, {'ForeName': 'Donglei', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Jackson', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Jarjour', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'Department of Internal Medicine, Division of Genetics, Genomics, and Precision Medicine, University of Arizona College of Medicine, Tucson, AZ, USA.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Krishnan', 'Affiliation': 'Breathe Chicago Center, Division of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Lazarus', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Lemanske', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Lima', 'Affiliation': ""Center for Pharmacogenomics and Translational Research, Nemours Children's Health System, Jacksonville, FL, USA.""}, {'ForeName': 'Njira', 'Initials': 'N', 'LastName': 'Lugogo', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Mak', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Moore', 'Affiliation': 'Department of Internal Medicine, Section for Pulmonary, Critical Care, Allergy, and Immunologic Diseases, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Naureckas', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Department of Internal Medicine, Section for Pulmonary, Critical Care, Allergy, and Immunologic Diseases, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Pongracic', 'Affiliation': ""Department of Pediatrics, Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Satria P', 'Initials': 'SP', 'LastName': 'Sajuthi', 'Affiliation': 'Center for Genes, Environment, and Health, Department of Pediatrics, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Seibold', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, CO, USA; Center for Genes, Environment, and Health, Department of Pediatrics, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Solway', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Sorkness', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wenzel', 'Affiliation': 'Department of Environmental and Occupational Health, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'White', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Esteban G', 'Initials': 'EG', 'LastName': 'Burchard', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Barnes', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Meyers', 'Affiliation': 'Department of Internal Medicine, Division of Genetics, Genomics, and Precision Medicine, University of Arizona College of Medicine, Tucson, AZ, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Department of Pulmonary and Critical Care Medicine and Allergy and Immunology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, CO, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(21)00268-6']
2829,34762789,Effects of an interdisciplinary weight loss program on fibroblast growth factor 21 and inflammatory biomarkers in women with overweight and obesity.,"Objective


To investigate the effects of an interdisciplinary intervention on biomarkers of inflammation and their relationship with fibroblast growth factor 21 (FGF21) concentrations in women with overweight and obesity.
Methods


Thirty-one women were enrolled in a 12-week interdisciplinary weight loss program delivered by a team comprising an endocrinologist, nutritionist and exercise physiologist. Body composition; anthropometric measures; metabolic and inflammatory markers including adiponectin, leptin, and atrial natriuretic peptide (ANP) were assessed at baseline and post-therapy. The homeostasis model assessment of insulin resistance (HOMA-IR) and the homeostasis model assessment of adiponectin (HOMA-AD) were calculated. The participants were divided into two groups: those with increased FGF21, and those with decreased FGF21.
Results


The sample comprised women aged 32 ± 5 years with a body mass index of 33.64 ± 3.49 kg/m 2 . Body weight, waist circumference and leptin concentration were decreased in the whole sample after therapy. However, only the group with an increase in FGF21 concentration presented significant improvements in adiponectin concentration and adiponectin/leptin ratio. Moreover, although there was a reduction of leptin in both groups, it was greater in the increased FGF21 groups. There was a reduction in ANP in the decreased FGF21 group.
Conclusion


Changes in FGF21 concentrations were different among the women participating in the weight loss program, with some having increased levels and some reduced levels. Furthermore, improvements in adiponectin and the adiponectin/leptin ratio were found only in the group with increased FGF21 concentration.",2021,"However, only the group with an increase in FGF21 concentration presented significant improvements in adiponectin concentration and adiponectin/leptin ratio.","['Methods\n\n\nThirty-one women were enrolled in a 12-week', 'sample comprised women aged 32 ± 5 years with a body mass index of 33.64 ± 3.49 kg/m 2 ', 'women with overweight and obesity']","['interdisciplinary weight loss program delivered by a team comprising an endocrinologist, nutritionist and exercise physiologist', 'interdisciplinary intervention', 'interdisciplinary weight loss program']","['reduction in ANP', 'adiponectin and the adiponectin/leptin ratio', 'fibroblast growth factor 21 and inflammatory biomarkers', 'reduction of leptin', 'adiponectin concentration and adiponectin/leptin ratio', 'Body weight, waist circumference and leptin concentration', 'Body composition; anthropometric measures; metabolic and inflammatory markers including adiponectin, leptin, and atrial natriuretic peptide (ANP', 'FGF21 concentrations', 'homeostasis model assessment of insulin resistance (HOMA-IR) and the homeostasis model assessment of adiponectin (HOMA-AD']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0259863', 'cui_str': 'Endocrinologist'}, {'cui': 'C0237083', 'cui_str': 'Nutritionist'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",31.0,0.0233153,"However, only the group with an increase in FGF21 concentration presented significant improvements in adiponectin concentration and adiponectin/leptin ratio.","[{'ForeName': 'Ana Raimunda', 'Initials': 'AR', 'LastName': 'Dâmaso', 'Affiliation': 'Programa de Pós-graduação em Nutrição, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brasil, ana.damaso@unifesp.br.'}, {'ForeName': 'Paola Próspero', 'Initials': 'PP', 'LastName': 'Machado', 'Affiliation': 'Programa de Pós-graduação em Nutrição, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'Samantha Ottani', 'Initials': 'SO', 'LastName': 'Rhein', 'Affiliation': 'Programa de Pós-graduação em Nutrição, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'Deborah Cristina Landi', 'Initials': 'DCL', 'LastName': 'Masquio', 'Affiliation': 'Centro Universitário São Camilo, São Paulo, SP, Brasil.'}, {'ForeName': 'Lila Missae', 'Initials': 'LM', 'LastName': 'Oyama', 'Affiliation': 'Programa de Pós-graduação em Nutrição, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'Valter Tadeu', 'Initials': 'VT', 'LastName': 'Boldarine', 'Affiliation': 'Programa de Pós-graduação em Nutrição, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'Gabriela Iervolino', 'Initials': 'GI', 'LastName': 'de Oliveira', 'Affiliation': 'Grupo de Estudos da Obesidade (GEO/UNIFESP), Escola Paulista de Medicina, São Paulo, SP, Brasil.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Tock', 'Affiliation': 'Grupo de Estudos da Obesidade (GEO/UNIFESP), Escola Paulista de Medicina, São Paulo, SP, Brasil.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France; CRNH-Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Raquel Munhoz', 'Initials': 'RM', 'LastName': 'da Silveira Campos', 'Affiliation': 'Departamento de Biociências, Universidade Federal de São Paulo, Campus Baixada Santista, Santos, SP, Brasil, raquel.munhoz@unifesp.br.'}]",Archives of endocrinology and metabolism,['10.20945/2359-3997000000419']
2830,34762781,Radiofrequency ablation of thyroid nodules: prospective cost-effectiveness analysis in comparison to conventional thyroidectomy.,"Objective


The objective of this study is to compare the total costs of surgery and radiofrequency (RF) ablation for the treatment of benign thyroid nodules.
Methods


This is a prospective randomized study comparing cases treated with US-guided RF ablation (cases) and surgery (control). They were selected and allocated to groups (thyroidectomy or radioablation) by permuted block randomization in blocks of five cases each.
Results


Five cases of RF Ablation were compared with five cases of thyroidectomies conducted in the same period. Similar complication rates were observed in both groups. Shorter operating time and hospital stay were observed for the RF group. In the evaluation of the total cost between procedures, radioblation represented 76% of the cost of partial thyroidectomy.
Conclusion


This study demonstrated that radioablation has a competitive cost, making it an effective alternative in the treatment of benign thyroid nodules.",2021,"In the evaluation of the total cost between procedures, radioblation represented 76% of the cost of partial thyroidectomy.
",[],"['RF Ablation', 'surgery and radiofrequency (RF) ablation', 'Radiofrequency ablation of thyroid nodules', 'US-guided RF ablation (cases) and surgery (control', 'thyroidectomy or radioablation', 'conventional thyroidectomy']","['Shorter operating time and hospital stay', 'Similar complication rates']",[],"[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040137', 'cui_str': 'Thyroid nodule'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.00453574,"In the evaluation of the total cost between procedures, radioblation represented 76% of the cost of partial thyroidectomy.
","[{'ForeName': 'Marcelo Soares', 'Initials': 'MS', 'LastName': 'Schalch', 'Affiliation': 'Departamento de Cirurgia de Cabeça e Pescoço, Instituto do Câncer Arnaldo Vieira de Carvalho (ICAVC), São Paulo, SP, Brasil.'}, {'ForeName': 'Anna Carolina Novais', 'Initials': 'ACN', 'LastName': 'Costa', 'Affiliation': 'Departamento de Cirurgia de Cabeça e Pescoço, Instituto do Câncer Arnaldo Vieira de Carvalho (ICAVC), São Paulo, SP, Brasil.'}, {'ForeName': 'Rafael Pereira', 'Initials': 'RP', 'LastName': 'de Souza', 'Affiliation': 'Departamento de Cirurgia de Cabeça e Pescoço, Instituto do Câncer Arnaldo Vieira de Carvalho (ICAVC), São Paulo, SP, Brasil.'}, {'ForeName': 'Filipe Lamounier Barros', 'Initials': 'FLB', 'LastName': 'Guerra', 'Affiliation': 'Departamento de Cirurgia de Cabeça e Pescoço, Instituto do Câncer Arnaldo Vieira de Carvalho (ICAVC), São Paulo, SP, Brasil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Guerreiro', 'Affiliation': 'Departamento de Cirurgia de Cabeça e Pescoço, Instituto do Câncer Arnaldo Vieira de Carvalho (ICAVC), São Paulo, SP, Brasil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'De Cicco', 'Affiliation': 'Departamento de Cirurgia de Cabeça e Pescoço, Instituto do Câncer Arnaldo Vieira de Carvalho (ICAVC), São Paulo, SP, Brasil, rafaeldecicco@gmail.com.'}]",Archives of endocrinology and metabolism,['10.20945/2359-3997000000411']
2831,34762770,HIV-1 drug resistance among individuals who seroconverted in the ASPIRE dapivirine ring trial.,"INTRODUCTION


A potential concern with the use of dapivirine (DPV) for HIV prevention is the selection of a drug-resistant virus that could spread and reduce the effectiveness of non-nucleoside reverse transcriptase (NNRTI)-based first-line antiretroviral therapy. We evaluated HIV-1 seroconversions in MTN-020/ASPIRE for selection of drug resistance and evaluated the genetic basis for observed reductions in susceptibility to DPV.
METHODS


MTN-020/ASPIRE was a placebo-controlled, Phase III safety and effectiveness study of DPV ring for HIV-1 prevention conducted at 15 sites in South Africa, Zimbabwe, Malawi and Uganda between 2012 and 2015. Plasma from individuals who seroconverted in ASPIRE was analysed for HIV-1 drug resistance using both population Sanger sequencing and next-generation sequencing (NGS) with unique molecular identifiers to report mutations at ≥1% frequency. DPV susceptibility of plasma-derived recombinant HIV-1 containing bulk-cloned full-length reverse transcriptase sequences from MTN-020/ASPIRE seroconversions was determined in TZM-bl cells. Statistical significance was calculated using the Fisher's exact test.
RESULTS


Plasma from all 168 HIV seroconversions were successfully tested by Sanger sequencing; 57 of 71 DPV arm and 82 of 97 placebo (PLB) arm participants had NGS results at 1% sensitivity. Overall, 18/168 (11%) had NNRTI mutations including K101E, K103N/S, V106M, V108I, E138A/G, V179D/I/T and H221Y. Five samples from both arms had low-frequency NNRTI mutations that were not detected by Sanger sequencing. The frequency of NNRTI mutations from the DPV arm (11%) was not different from the PLB arm (10%; p = 0.80). The E138A mutation was detected in both the DPV (3 of 71 [4.2%]) and PLB arm (5 of 97 [5.2%]) and conferred modest reductions in DPV susceptibility in some reverse transcriptase backgrounds but not others.
CONCLUSIONS


HIV-1 drug resistance including NNRTI resistance did not differ between the DPV and placebo arms of the MTN-020/ASPIRE study, indicating that drug resistance was not preferentially acquired or selected by the DPV ring and that the preventive benefit of DPV ring outweighs resistance risk.",2021,"RESULTS


Plasma from all 168 HIV seroconversions were successfully tested by Sanger sequencing; 57 of 71 DPV arm and 82 of 97 placebo (PLB) arm participants had NGS results at 1% sensitivity.","['HIV-1 prevention conducted at 15 sites in South Africa, Zimbabwe, Malawi and Uganda between 2012 and 2015', 'individuals who seroconverted in the ASPIRE dapivirine ring trial']","['MTN-020/ASPIRE', 'placebo (PLB', 'dapivirine (DPV']","['NNRTI resistance', 'frequency of NNRTI mutations']","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}]","[{'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0035379', 'cui_str': 'RNA-directed DNA polymerase'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",,0.182712,"RESULTS


Plasma from all 168 HIV seroconversions were successfully tested by Sanger sequencing; 57 of 71 DPV arm and 82 of 97 placebo (PLB) arm participants had NGS results at 1% sensitivity.","[{'ForeName': 'Urvi M', 'Initials': 'UM', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Kerri J', 'Initials': 'KJ', 'LastName': 'Penrose', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Heaps', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Elias K', 'Initials': 'EK', 'LastName': 'Halvas', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'B Jay', 'Initials': 'BJ', 'LastName': 'Goetz', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Kelley C', 'Initials': 'KC', 'LastName': 'Gordon', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Hardesty', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Rahil', 'Initials': 'R', 'LastName': 'Sethi', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Schwarzmann', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Szydlo', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Marla J', 'Initials': 'MJ', 'LastName': 'Husnik', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Chandran', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Johannesburg, South Africa.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Departments of Global Health, Medicine, Epidemiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Mellors', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25833']
2832,34762764,A cluster randomised controlled trial of a MedicineInsight Educational QUality Improvement Program to improve the diagnosis and treatment of chronic HEPatitis C in general practice (the EQUIP-HEPC trial).,"The availability of direct acting antivirals (DAAs) sparked efforts to eliminate hepatitis C virus (HCV) in Australia. We evaluated whether an educational intervention of a 1-hour discussion among staff using audit and feedback data from MedicineInsight GP program would improve DAA uptake. Of 296 eligible general practices in MedicineInsight 11% opted out. Randomisation stratified by practice caseload allocated 130 practices to the intervention arm and 129 to control. The primary outcome was the number of patients started on DAAs over 6 months using the negative binomial regression model adjusted for DAA prescribing history and clustering by practice. Data for analysis were available for 78% of practices, which included 101 practices and 2,469 DAA-naive patients with confirmed/possible HCV in the intervention arm; and 100 practices and 2,466 patients in the control arm. At baseline: 49.5% of practices had prescribed ≥1 DAA in the past year; 18.9% of HCV patients had already been treated with DAAs; the mean age of DAA-naive HCV patients was 43 years and 57% were male. Over 6 months, 43 patients in the intervention arm and 36 in the control arm started DAAs (adjusted IRR 1.19; 95% CI 0.67-2.11, p=0.55). In the first 3 months 27 vs 16 patients started DAAs (adjusted IRR 1.77, 0.88-3.58; p=0.111). Few patients were started on DAAs and a facilitated discussion in HCV management did not lead to a significant increase. Alternative measures, such as incentivising GP initiations or patients, are suggested to address remaining barriers to DAA uptake in Australian primary care.",2021,"In the first 3 months 27 vs 16 patients started DAAs (adjusted IRR 1.77, 0.88-3.58; p=0.111).",['296 eligible general practices in MedicineInsight 11% opted out'],['MedicineInsight Educational QUality Improvement Program'],"['number of patients started on DAAs', 'DAA uptake']","[{'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C3653501', 'cui_str': 'DIRECT ACTING ANTIVIRALS'}]",,0.0304067,"In the first 3 months 27 vs 16 patients started DAAs (adjusted IRR 1.77, 0.88-3.58; p=0.111).","[{'ForeName': 'Kendal', 'Initials': 'K', 'LastName': 'Chidwick', 'Affiliation': 'MedicineInsight, NPS MedicineWise, Sydney, Australia.'}, {'ForeName': 'Rimma', 'Initials': 'R', 'LastName': 'Myton', 'Affiliation': 'MedicineInsight, NPS MedicineWise, Sydney, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Jun', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Dartnell', 'Affiliation': 'MedicineInsight, NPS MedicineWise, Sydney, Australia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Balcomb', 'Affiliation': 'Prince St Medical Practice, Orange, NSW, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Dore', 'Affiliation': 'The Kirby Institute, UNSW Sydney, Sydney, Australia.'}]",Journal of viral hepatitis,['10.1111/jvh.13629']
2833,34762756,'It's like having a core belief that's able to speak back to you': Therapist accounts of dialoguing with auditory hallucinations.,"PURPOSE


To investigate the clinical perspectives and experiences of therapists when engaging in direct dialogue with auditory hallucinations.
METHOD


Therapist accounts were explored via a qualitative study nested within a pilot randomized controlled trial of a novel intervention for supporting distressed voice-hearers (Talking with Voices). Five therapists were involved, none of whom had substantive previous experience of the technique. All agreed to take part in two semi-structured, in-depth interviews which were arranged prior to delivering therapy and again after therapists had experience of conducting dialogues. Data were analysed using inductive thematic analysis.
RESULTS


Participants described their impressions of seeking to improve the relationship between voice(s) and voice-hearer using dialogue. The findings are organized within three main themes and associated subthemes: (1) Commitment to delivery (professional values, mentorship, professional growth); (2) Communication and collaboration (therapeutic alliance, relationships with voices, managing clinical perceptions); and (3) Challenges of delivery (client/voice engagement, impact of trauma, systemic issues). A series of recommendations are derived from the findings to support implementation and guide the practice of therapists undertaking dialogue work with clients who hear voices.
CONCLUSION


Despite clinical challenges, therapists also identified professional gains from conducting their work. Their accounts demonstrate that it is possible for practitioners with no previous formal experience to engage in direct communication with voices within a context of appropriate training and supervision.
PRACTITIONER POINTS


Therapists with no previous experience of dialogue work can be trained and supported to verbally engage with the voices heard by people experiencing psychosis. Therapeutic alliance and therapist values are important components of successful therapy. Confidence for dialoguing with voices can be increased through drawing on therapist's existing transferable clinical skills. The emotional and practical needs of therapists undertaking such work should be addressed through training and regular group supervision.",2021,"A series of recommendations are derived from the findings to support implementation and guide the practice of therapists undertaking dialogue work with clients who hear voices.
",['distressed voice-hearers (Talking with Voices'],['novel intervention'],[],"[{'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],5.0,0.0479041,"A series of recommendations are derived from the findings to support implementation and guide the practice of therapists undertaking dialogue work with clients who hear voices.
","[{'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Longden', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Branitsky', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Jones', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, School of Health Sciences, Manchester Academic Health Science Centre, The University of Manchester, UK.'}]",Psychology and psychotherapy,['10.1111/papt.12373']
2834,34762753,Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants.,,2021,,['preterm infants'],['azithromycin'],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",[],,0.165575,,"[{'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Gandecha', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Boyle', 'Affiliation': 'University of Leicester, Leicester, UK.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.16159']
2835,34762734,Evaluating the association of frailty with communication about aging-related concerns between older patients with advanced cancer and their oncologists.,"BACKGROUND


A geriatric assessment (GA) intervention improves communication about aging-related concerns, but its effect on communication in patients with various levels of frailty is unknown.
METHODS


This was a secondary analysis of a nationwide trial of patients aged ≥70 years with incurable cancer and impairment on 1 or more GA domains (ClinicalTrials.gov Identifier NCT02107443; principal investigator Supriya G. Mohile). Practice sites were randomized to either the GA-intervention or usual care. Frailty was assessed with a deficit accumulation index (range, 0-1), and patients were stratified as robust (0 to <0.2), prefrail (0.2 to <0.35), or frail (≥0.35). The clinic visit after the GA-intervention was audio-recorded, transcribed, and coded to evaluate the number and quality of conversations about aging-related concerns. Linear mixed models examined differences in the number and quality of conversations within and between arms. All P values were 2-sided.
RESULTS


Patients (n = 541) were classified as robust (27%), prefrail (42%), or frail (31%). In the usual care arm, frail patients (vs robust ones) engaged in more aging-related conversations (adjusted mean difference, 1.73; 95% confidence interval [CI], 0.59-2.87), conversations of higher quality (difference, 1.12; 95% CI, 0.24-2.0), and more discussions about evidence-based recommendations (difference, 0.71; 95% CI, 0.04-1.38; all P values ≤ .01). Similarly, in the GA intervention arm, frail patients (vs robust ones) engaged in more aging-related conversations (difference, 2.49; 95% CI, 1.51-3.47), conversations of higher quality (difference, 1.31; 95% CI, 0.56-2.06), and more discussions about evidence-based recommendations (difference, 0.87; 95% CI, 0.32-1.42; all P values ≤ .01). Furthermore, the GA-intervention significantly improved the number and quality of conversations in all patients: robust, prefrail, and frail (all P values ≤ .01).
CONCLUSIONS


Patients with higher degrees of frailty and those exposed to the GA-intervention had more and higher quality conversations about aging-related concerns with oncologists.
LAY SUMMARY


A geriatric assessment (GA) intervention improves communication about aging-related concerns, but its effect on communication in patients with various levels of frailty is unknown. This study conducted a secondary analysis of a nationwide trial of patients aged ≥70 years with incurable cancer and 1 or more GA domain impairments. Patients were stratified as robust, prefrail, or frail. The number and quality of conversations about aging-related concerns that occurred during the clinic visit after the GA-intervention were determined. Patients with higher degrees of frailty and those in the GA intervention arm had more and higher quality conversations about aging-related concerns with oncologists.",2021,Patients with higher degrees of frailty and those in the GA intervention arm had more and higher quality conversations about aging-related concerns with oncologists.,"['older patients with advanced cancer and their oncologists', 'Patients (n = 541) were classified as robust (27%), prefrail (42%), or frail (31', 'patients aged ≥70 years with incurable cancer and 1 or more GA domain impairments', 'Patients with higher degrees of frailty and those in the', 'patients aged ≥70 years with incurable cancer and impairment on 1 or more GA domains (ClinicalTrials.gov Identifier NCT02107443; principal investigator Supriya G. Mohile']","['GA) intervention', 'GA-intervention or usual care', 'GA intervention']","['number and quality of conversations about aging-related concerns', 'quality conversations', 'number and quality of conversations', 'conversations of higher quality']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C1521895', 'cui_str': 'Principal investigator'}]","[{'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205250', 'cui_str': 'High'}]",541.0,0.106221,Patients with higher degrees of frailty and those in the GA intervention arm had more and higher quality conversations about aging-related concerns with oncologists.,"[{'ForeName': 'Nikesha', 'Initials': 'N', 'LastName': 'Gilmore', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Kehoe', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Amber S', 'Initials': 'AS', 'LastName': 'Kleckner', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Moorthi', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Lianlian', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Mostafa R S', 'Initials': 'MRS', 'LastName': 'Mohamed', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Kah Poh Melissa', 'Initials': 'KPM', 'LastName': 'Loh', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Flannery', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Ramsdale', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Rutgers University School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Canin', 'Affiliation': 'SCOREboard Stakeholder Advisory Group, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kamen', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Giri', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Watson', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Patil', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Adedayo A', 'Initials': 'AA', 'LastName': 'Onitilo', 'Affiliation': 'Wisconsin National Cancer Institute Community Oncology Research Program, Marshfield, Wisconsin.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Burnette', 'Affiliation': 'Cancer Research of Wisconsin and Northern Michigan, Green Bay, Wisconsin.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Janelsins', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}]",Cancer,['10.1002/cncr.34010']
2836,34762724,Intra-operative application of ultrasonography combined with limited radiography for the treatment of supracondylar humerus fractures in children: a randomized controlled trial.,"AIMS


To introduce a new method of intra-operative application of ultrasonography (US) combined with limited radiography to treat supracondylar humerus fractures in children and evaluate its effect on radiation protection.
MATERIAL AND METHODS


Fifty patients were randomly divided into the radiography-only group (RO group, n = 22) and the US combined with the limited radiography group (UR group, n = 28). US was performed to evaluate fracture displacement and to guide reduction in the UR group. The primary outcome measures were the average number of radiography instances and the quantitative value of radiation emission. Secondary outcome measures were length of hospital stays, loss of range of motion, loss of carrying angle, loss of Baumann angle, fracture healing time, pin site infection, compartment syndrome, cubitus varus, cubitus valgus, and iatrogenic ulnar nerve injury.
RESULTS


Average number of radiography instances and quantitative value of radiation emission in the UR group decreased compared with the RO group (p<0.05). There were no significant differences between the groups regarding mean time to surgery, the average length of hospital stays, average surgery time, radiological union time, Flynn grade, or loss of Baumann angle. Pin site infection was seen in one patient in the RO group and two patients in the UR group. No other complications occurred.
CONCLUSION


Intra-operative application of US combined with limited radiography decreases radiation exposure during treatment of supracondylar humerus fractures in children without compromising the therapeutic effect.",2021,"There were no significant differences between the groups regarding mean time to surgery, the average length of hospital stays, average surgery time, radiological union time, Flynn grade, or loss of Baumann angle.","['Fifty patients', 'supracondylar humerus fractures in children']","['ultrasonography combined with limited radiography', 'radiography-only group (RO group, n = 22) and the US combined with the\xa0limited radiography', 'ultrasonography (US) combined with limited radiography']","['average number of radiography instances and the quantitative value of\xa0radiation emission', 'radiography instances and quantitative value of radiation emission', 'mean time to surgery, the average length of hospital stays, average surgery time, radiological union time, Flynn grade,\xa0or loss of Baumann angle', 'length of hospital stays, loss of range of motion, loss of carrying angle,\xa0loss of Baumann angle, fracture healing time, pin site infection, compartment syndrome, cubitus varus, cubitus valgus, and iatrogenic\xa0ulnar nerve injury', 'Pin site infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0347788', 'cui_str': 'Supracondylar fracture of humerus'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0578491', 'cui_str': 'Infection by site'}, {'cui': 'C0009492', 'cui_str': 'Compartment syndrome'}, {'cui': 'C0158466', 'cui_str': 'Acquired cubitus varus'}, {'cui': 'C0158465', 'cui_str': 'Acquired cubitus valgus'}, {'cui': 'C0161458', 'cui_str': 'Injury of ulnar nerve'}]",50.0,0.042265,"There were no significant differences between the groups regarding mean time to surgery, the average length of hospital stays, average surgery time, radiological union time, Flynn grade, or loss of Baumann angle.","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedics Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou,China. liyuanzhejiang@163.com.""}, {'ForeName': 'Zongyi', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopaedics Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou,China. 810116063@qq.com.""}, {'ForeName': 'Xianhong', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': ""Department of Orthopaedics Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou,China. wzfeyyxh@163.com.""}, {'ForeName': 'Chenghuang', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': ""Department of Orthopaedics Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou,China. 294436616@qq.com.""}, {'ForeName': 'Guangkui', 'Initials': 'G', 'LastName': 'Yan', 'Affiliation': ""Department of Orthopaedics Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou,China. 56815083@qq.com.""}, {'ForeName': 'Mingqiao', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': ""Department of Orthopaedics Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou,China. 279246195@qq.com.""}, {'ForeName': 'Tianlong', 'Initials': 'T', 'LastName': 'Pan', 'Affiliation': ""Department of Orthopaedics Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou,China. 785289389@qq.com.""}, {'ForeName': 'Ruibo', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': ""Department of Orthopaedics Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou,China. 198759094@qq.com.""}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou,China. zjdegd07@163.com.""}]",Medical ultrasonography,['10.11152/mu-3300']
2837,34762713,"Effects of a school-based intervention to reduce cardiovascular disease risk factors among secondary school students: A cluster-randomized, controlled trial.","BACKGROUND


Cardiovascular diseases (CVDs) are the number cause of death worldwide. In Ghana CVD has been the leading cause of death since 2001. The prevalence of CVD risk factors among adolescents in Ghana has been increasing. This study seeks to develop, implement and evaluate the effects of a behavioral modification intervention program to reduce CVD risk factors among secondary school students in Brong Ahafo, Ghana.
METHODS


A cluster-randomized controlled trial was conducted with schools as clusters over a period of six-months with pre and post intervention evaluations. Participants were public secondary school students (14-19 years) from four schools in Brong Ahafo, Ghana. Students in the intervention group were trained by the researchers whereas those of the control group received no intervention. The intervention included health education and physical activity modules. Follow-up data using same questionnaire were collected within two weeks after the intervention was completed. Intention-to-treat analysis was performed after replacing missing values using the multiple imputation method. The generalized linear mixed model (GLMM) was used to assess the effects of the intervention study.
RESULTS


The GLMM analyses showed the intervention was effective in attaining 0.77(p<0.001), 0.72(p<0.001), 0.47(p<0.001), 0.56(p<0.001), and 0.39(p = 0.045) higher total physical activity, fruits, vegetables, seafood, and water scores respectively for the intervention group over the control group. The intervention was also significant in reducing -0.15(p<0.001),-0.23(p<0.001),-0.50(p<0.001),-0.32(p<0.001),-0.90(p<0.001),-0.87(p<0.001),-0.38(p<0.001), -0.63(p<0.001), -1.63(p<0.001), 0.61(p<0.001), and -1.53(p = 0.005) carbohydrates, fats and oils, fried eggs, fried chicken, carbonated drinks, sugar, sweet snacks, salted fish, weight, BMI, and diastolic BP. The odds of quitting alcohol use in the intervention group were 1.06 times more than the control group. There was no significant effect on reducing smoking and systolic BP.
CONCLUSION


There is an urgent need for the intervention program to be integrated into the existing curriculum structure of secondary school schools. Implementing the intervention will allow for longer and more consistent impact on the reduction of CVD risk factors among secondary school students.",2021,"The GLMM analyses showed the intervention was effective in attaining 0.77(p<0.001), 0.72(p<0.001), 0.47(p<0.001), 0.56(p<0.001), and 0.39(p = 0.045) higher total physical activity, fruits, vegetables, seafood, and water scores respectively for the intervention group over the control group.","['secondary school students', 'secondary school students in Brong Ahafo, Ghana', 'Participants were public secondary school students (14-19 years) from four schools in Brong Ahafo, Ghana', 'adolescents in Ghana']","['control group received no intervention', 'school-based intervention', 'behavioral modification intervention program']","['cardiovascular disease risk factors', 'CVD risk factors', 'health education and physical activity modules', 'odds of quitting alcohol use', 'reducing -0.15(p<0.001),-0.23(p<0.001),-0.50(p<0.001),-0.32(p<0.001),-0.90(p<0.001),-0.87(p<0.001),-0.38(p<0.001), -0.63(p<0.001), -1.63(p<0.001), 0.61(p<0.001), and -1.53(p = 0.005) carbohydrates, fats and oils, fried eggs, fried chicken, carbonated drinks, sugar, sweet snacks, salted fish, weight, BMI, and diastolic BP', 'reducing smoking and systolic BP', 'total physical activity, fruits, vegetables, seafood, and water scores']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452829', 'cui_str': 'Dietary fats and oils'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0007025', 'cui_str': 'Carbonated drink'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0468662,"The GLMM analyses showed the intervention was effective in attaining 0.77(p<0.001), 0.72(p<0.001), 0.47(p<0.001), 0.56(p<0.001), and 0.39(p = 0.045) higher total physical activity, fruits, vegetables, seafood, and water scores respectively for the intervention group over the control group.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Amoah', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Bono-East, Ghana.'}, {'ForeName': 'Salmiah', 'Initials': 'S', 'LastName': 'Said', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, University Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Lekhraj', 'Initials': 'L', 'LastName': 'Rampal', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, University Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Rosliza', 'Initials': 'R', 'LastName': 'Manaf', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, University Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Normala', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Health Sciences, University Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': 'Department of Public Health, University of Health and Allied Science, Ho, Volta, Ghana.'}, {'ForeName': 'Kwaku', 'Initials': 'K', 'LastName': 'Poku Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Bono-East, Ghana.'}]",PloS one,['10.1371/journal.pone.0259581']
2838,34762677,Clinical impact of implementing a rapid-response team based on the Modified Early Warning Score in wards that offer emergency department support.,"BACKGROUND


Emergency department (ED) crowding is a frequent situation. To decrease this overload, patients without a life-threating condition are transferred to wards that offer ED support. This study aimed to evaluate if implementing a rapid response team (RRT) triggered by the modified early warning score (MEWS) in high-risk wards offering ED support is associated with decreased in-hospital mortality rate.
METHODS


A before-and-after cross-sectional study compared in-hospital mortality rates before and after implementation of an RRT triggered by the MEWS ≥4 in two wards of a tertiary hospital that offer ED support.
RESULTS


We included 6863 patients hospitalized in these wards before RRT implementation from July 2015 through June 2017 and 6944 patients hospitalized in these same wards after RRT implementation from July 2018 through June 2020. We observed a statistically significant decrease in the in-hospital mortality rate after intervention, 449 deaths/6944 hospitalizations [6.47% (95% confidence interval (CI) 5.91%- 7.07%)] compared to 534 deaths/6863 hospitalizations [7.78% (95% CI 7.17-8.44)] before intervention; with an absolute risk reduction of -1.31% (95% CI -2.20 --0.50).
CONCLUSION


RRT trigged by the MEWS≥4 in high-risk wards that offer ED support was found to be associated with a decreased in-hospital mortality rate. A further cluster-randomized trial should evaluate the impact of this intervention in this setting.",2021,"We observed a statistically significant decrease in the in-hospital mortality rate after intervention, 449 deaths/6944 hospitalizations [6.47% (95% confidence interval (CI) 5.91%- 7.07%)] compared to 534 deaths/6863 hospitalizations [7.78% (95% CI 7.17-8.44)] before intervention; with an absolute risk reduction of -1.31% (95% CI -2.20 --0.50).
","['6863 patients hospitalized in these wards before RRT implementation from July 2015 through June 2017 and 6944 patients hospitalized in these same wards after RRT implementation from July 2018 through June 2020', 'A before-and-after cross-sectional study compared in-hospital mortality rates before and after implementation of an RRT triggered by the MEWS ≥4 in two wards of a tertiary hospital that offer ED support']",[],['hospital mortality rate'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C2718033', 'cui_str': 'Hospital Medical Emergency Team'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],"[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",6863.0,0.0533732,"We observed a statistically significant decrease in the in-hospital mortality rate after intervention, 449 deaths/6944 hospitalizations [6.47% (95% confidence interval (CI) 5.91%- 7.07%)] compared to 534 deaths/6863 hospitalizations [7.78% (95% CI 7.17-8.44)] before intervention; with an absolute risk reduction of -1.31% (95% CI -2.20 --0.50).
","[{'ForeName': 'Lorena Micheline', 'Initials': 'LM', 'LastName': 'Alves Silva', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Diego Marques', 'Initials': 'DM', 'LastName': 'Moroço', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'José Paulo', 'Initials': 'JP', 'LastName': 'Pintya', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Miranda', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0259577']
2839,34762673,An intervention to improve teacher well-being support and training to support students in UK high schools (the WISE study): A cluster randomised controlled trial.,"BACKGROUND


Teachers are at heightened risk of poor mental health and well-being, which is likely to impact on the support they provide to students, and student outcomes. We conducted a cluster randomised controlled trial, to test whether an intervention to improve mental health support and training for high school teachers led to improved mental health and well-being for teachers and students, compared to usual practice. We also conducted a cost evaluation of the intervention.
METHODS AND FINDINGS


The intervention comprised (i) Mental Health First Aid training for teachers to support students; (ii) a mental health awareness session; and (iii) a confidential staff peer support service. About 25 mainstream, non-fee-paying secondary schools stratified by geographical area and free school meal entitlement were randomly allocated to intervention (n = 12) or control group (n = 13) after collection of baseline measures. We analysed data using mixed-effects repeated measures models in the intention-to-treat population, adjusted for stratification variables, sex, and years of experience. The primary outcome was teacher well-being (Warwick-Edinburgh Mental Well-being Scale). Secondary outcomes were teacher depression, absence, and presenteeism, and student well-being, mental health difficulties, attendance, and attainment. Follow-up was at months 12 (T1) and 24 (T2). We collected process data to test the logic model underpinning the intervention, to aid interpretation of the findings. A total of 1,722 teachers were included in the primary analysis. Teacher well-being did not differ between groups at T2 (intervention mean well-being score 47.5, control group mean well-being score 48.4, adjusted mean difference -0.90, 95% CI -2.07 to 0.27, p = 0.130). The only effect on secondary outcomes was higher teacher-reported absence among the intervention group at T2 (intervention group median number of days absent 0, control group median number of days absent 0, ratio of geometric means 1.04, 95% CI 1.00 to 1.09, p = 0.042). Process measures indicated little change in perceived mental health support, quality of relationships, and work-related stress. The average cost of the intervention was £9,103 per school. The study's main limitations were a lack of blinding of research participants and the self-report nature of the outcome measures.
CONCLUSIONS


In this study, we observed no improvements to teacher or student mental health following the intervention, possibly due to a lack of impact on key drivers of poor mental health within the school environment. Future research should focus on structural and cultural changes to the school environment, which may be more effective at improving teacher and student mental health and well-being.
TRIAL REGISTRATION


www.isrctn.com ISRCTN95909211.",2021,"Teacher well-being did not differ between groups at T2 (intervention mean well-being score 47.5, control group mean well-being score 48.4, adjusted mean difference -0.90, 95% CI -2.07 to 0.27, p = 0.130).","['students in UK high schools (the WISE study', 'A total of 1,722 teachers were included in the primary analysis', 'About 25 mainstream, non-fee-paying secondary schools stratified by geographical area and free school meal entitlement']","['Mental Health First Aid training for teachers to support students; (ii) a mental health awareness session; and (iii) a confidential staff peer support service', 'teacher well-being support and training to support']","['perceived mental health support, quality of relationships, and work-related stress', 'average cost', 'teacher well-being (Warwick-Edinburgh Mental Well-being Scale', 'teacher depression, absence, and presenteeism, and student well-being, mental health difficulties, attendance, and attainment']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1276379', 'cui_str': 'First aid education'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4273514', 'cui_str': 'Warwick Edinburgh Mental Well Being Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",1722.0,0.115386,"Teacher well-being did not differ between groups at T2 (intervention mean well-being score 47.5, control group mean well-being score 48.4, adjusted mean difference -0.90, 95% CI -2.07 to 0.27, p = 0.130).","[{'ForeName': 'Judi', 'Initials': 'J', 'LastName': 'Kidger', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'DECIPHer, School of Social Sciences, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bell', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Brockman', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Copeland', 'Affiliation': 'DECIPHer, School of Social Sciences, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Fisher', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harding', 'Affiliation': 'School for Policy Studies, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'School for Policy Studies, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Centre for Population Neuroscience and Precision Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Campbell', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gunnell', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'DECIPHer, School of Social Sciences, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morris', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003847']
2840,34763080,Randomized Controlled Trial of a Cognitive Intervention to Improve Memory in Heart Failure.,"BACKGROUND


The objective of this 3-arm randomized controlled trial was to evaluate efficacy of computerized cognitive training (CCT) to improve primary outcomes of delayed recall memory and serum brain-derived neurotrophic factor (BDNF) levels and secondary outcomes of working memory, instrumental activities of daily living (IADL), and health-related quality of life (HRQL) among patients with heart failure (HF).
METHODS AND RESULTS


Patients (N = 256) were randomly assigned to 8 weeks of CCT using BrainHQ, computerized crossword puzzles active control intervention, and usual care. All patients received weekly nurse enhancement interventions. Data were collected at enrollment and baseline visits and at 10 weeks and 4 and 8 months. In mixed effects models, there were no statistically significant group or group by time differences in outcomes. There were statistically significant differences over time in all outcomes in all groups. Patients improved over time on measures of delayed recall memory, working memory, IADL, and HRQL and had decreased serum BDNF.
CONCLUSIONS


CCT did not improve outcomes compared with the active control intervention and usual care. Nurse enhancement interventions may have led to improved outcomes over time. Future studies are needed to test nurse enhancement interventions in combination with other cognitive interventions to improve memory in HF.
LAYSUMMARY


In 256 patients with heart failure, 8 weeks of computerized cognitive training, computerized crossword puzzles, or usual care were studied for effects on (1st) recall memory and serum brain-derived neurotrophic factor (BDNF) and (2nd) working memory, instrumental activities of daily living (IADL), and health-related quality of life (HRQL). Measurements were at baseline, 10 weeks, 4- and 8-months. Nurse enhancement interventions (e.g., support, assessment) were provided. Recall memory, working memory, IADL, and HRQL improved over time. There were no statistically significant differences among treatment groups over time. BDNF unexpectedly decreased. Nurse enhancement interventions may explain improved outcomes. Future studies are needed.",2021,"Patients improved over time on measures of delayed recall memory, working memory, IADL, and HRQL and had decreased serum BDNF.
","['256 patients with heart failure, 8 weeks of computerized cognitive training, computerized crossword puzzles, or usual care', 'patients with heart failure (HF', 'Patients (N\u202f=\u202f256']","['nurse enhancement interventions', 'Cognitive Intervention', 'CCT using BrainHQ, computerized crossword puzzles active control intervention, and usual care', 'computerized cognitive training (CCT', 'CCT']","['BDNF', 'Recall memory, working memory, IADL, and HRQL improved over time', 'Memory in Heart Failure', 'recall memory and serum brain-derived neurotrophic factor (BDNF) and (2nd) working memory, instrumental activities of daily living (IADL), and health-related quality of life (HRQL', 'delayed recall memory, working memory, IADL, and HRQL and had decreased serum BDNF', 'delayed recall memory and serum brain-derived neurotrophic factor (BDNF) levels and secondary outcomes of working memory, instrumental activities of daily living (IADL), and health-related quality of life (HRQL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0423995', 'cui_str': 'Puzzled'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0423995', 'cui_str': 'Puzzled'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",256.0,0.0569048,"Patients improved over time on measures of delayed recall memory, working memory, IADL, and HRQL and had decreased serum BDNF.
","[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Pressler', 'Affiliation': 'Indiana University School of Nursing, 600 Barnhill Drive, Indianapolis, IN 46202. Electronic address: sjpress@iu.edu.'}, {'ForeName': 'Miyeon', 'Initials': 'M', 'LastName': 'Jung', 'Affiliation': 'Indiana University School of Nursing, 600 Barnhill Drive, Indianapolis, IN 46202.'}, {'ForeName': 'Irmina', 'Initials': 'I', 'LastName': 'Gradus-Pizlo', 'Affiliation': 'University of California Irvine School of Medicine, 333 City Blvd, West, Suite 400, Orange, CA.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Titler', 'Affiliation': 'University of Michigan School of Nursing, 400 North Ingalls, Ann Arbor, Michigan 48109-5482.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Louisiana State University School of Public Health, 2020 Gravier Street, 3rd Floor, New Orleans, LA 70112.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Indiana University School of Medicine, Department of Biostatistics, 410 West 10(th)\xa0Street, Suite 3000, Indianapolis, IN 46202.'}, {'ForeName': 'Kittie Reid', 'Initials': 'KR', 'LastName': 'Lake', 'Affiliation': 'Indiana University School of Nursing, 600 Barnhill Drive, Indianapolis, IN 46202.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Burney', 'Affiliation': 'Indiana University School of Medicine, Department of Biostatistics, 410 West 10(th)\xa0Street, Suite 3000, Indianapolis, IN 46202.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Indiana University School of Medicine, 355 W. 16th Street, Suite 4020, Indianapolis, IN 46202.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Wierenga', 'Affiliation': 'Indiana University School of Nursing, 600 Barnhill Drive, Indianapolis, IN 46202.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Dorsey', 'Affiliation': 'University of Maryland School of Nursing, 655 West Lombard Street, Baltimore MD 21201.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giordani', 'Affiliation': ""University of Michigan, Michigan Alzheimer's Disease Research Center, Suite C, 2101 Commonwealth Blvd. Ann Arbor MI 48105.""}]",Journal of cardiac failure,['10.1016/j.cardfail.2021.10.008']
2841,34763071,"Basal Insulin degludec and GLycemic control ComparEd to Aspart via insulin Pump in type 1 diabetes (BIGLEAP): a single-center, open-label, randomized, crossover trial.","OBJECTIVE


We compared the efficacy of the second-generation basal insulin degludec (IDeg) to that of insulin aspart via pump using continuous glucose monitoring (CGM) in patients with well-controlled type 1 diabetes.
METHODS


In this 40-week, single center, randomized, crossover-controlled trial, adults with well-controlled type 1 diabetes (HbA1c <7.5%, <58 mmol/mol)(n=52) using an insulin pump and CGM were randomized to a 20-week treatment period of either a single daily injection of IDeg with bolus aspart via pump or continuous subcutaneous insulin infusion (CSII) with aspart, followed by crossover to the other treatment. Primary endpoint was time in range (TIR) (70 to 180 mg/dL) during the final two weeks of each treatment period.
RESULTS


52 subjects were randomized and completed both treatment periods. TIR was 71.5% with IDeg and 70.9% with CSII (p=0.553; NS). Time in level 1 hypoglycemia for the 24-hour period was 2.19% with IDeg and 1.75% with CSII (p=0.065). Time in level 2 hypoglycemia for the 24-hour period with IDeg was 0.355% and with CSII 0.271% (p=0.212; NS) and for the nocturnal period 0.330% and 0.381%, respectively (p=0.639; NS). The mean SD of blood glucose for the 24-hour period was 52.4 mg/dL with IDeg and 51.0 mg/dL with CSII (p=0.294; NS). Final HbA1c for each treatment was 7.04% (53 mmol/mol) with IDeg and 6.95% (52 mmol/mol) with CSII (p=0.288; NS). Adverse events were similar between treatments.
CONCLUSIONS


We observed similar glycemic control between IDeg and insulin aspart via CSII for basal insulin coverage in patients with well-controlled type 1 diabetes.",2021,TIR was 71.5% with IDeg and 70.9% with CSII (p=0.553; NS).,"['52 subjects', 'adults with well-controlled type 1 diabetes (HbA1c <7.5%, <58 mmol/mol)(n=52) using an insulin pump and CGM', 'patients with well-controlled type 1 diabetes']","['Aspart via insulin Pump', 'insulin aspart via CSII', 'IDeg with bolus aspart via pump or continuous subcutaneous insulin infusion (CSII) with aspart', 'second-generation basal insulin degludec (IDeg', 'insulin aspart via pump using continuous glucose monitoring (CGM']","['TIR', 'Adverse events', 'Time in level 2 hypoglycemia', 'mean SD of blood glucose', 'time in range (TIR', 'Time in level 1 hypoglycemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}]",52.0,0.0633229,TIR was 71.5% with IDeg and 70.9% with CSII (p=0.553; NS).,"[{'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Lane', 'Affiliation': 'Mountain Diabetes and Endocrine Center, Asheville, NC USA. Electronic address: mountaindiabetes@msn.com.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Weinrib', 'Affiliation': 'Mountain Diabetes and Endocrine Center, Asheville, NC USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Lawrence', 'Affiliation': 'Mountain Diabetes and Endocrine Center, Asheville, NC USA.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Lane', 'Affiliation': 'Department of Data Science, Vanderbilt University, Nashville, TN USA.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Jarrett', 'Affiliation': 'Department of Biostatistics, Vanderbilt University, Nashville, TN USA.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.1016/j.eprac.2021.11.001']
2842,34763045,"Efficacy and safety of Bufei Huoxue capsules in the management of convalescent patients with COVID-19 infection: A multicentre, double-blind, and randomised controlled trial.","BACKGROUND


As of July 22, 2021, coronavirus disease 2019 (COVID-19) has infected more than 192 million people in a worldwide pandemic, with conservative estimates suggesting that there are more than 175 million convalescent patients with COVID-19. Previous studies have indicated that patients in the recovery phase exhibit decreased function of multiple organs. In China, traditional Chinese medicine (TCM) treatment is recommended in the rehabilitation period of COVID-19; however, the safety and efficacy of such treatment remain to be confirmed.
AIM OF STUDY


The present study aimed to evaluate the efficacy and safety of Bufei Huoxue (BFHX) in restoring the functional status and exercise tolerance of patients recovering from COVID-19.
METHODS


A total of 131 patients in the rehabilitation period of COVID-19 infection were randomly divided into a Bufei Huoxue (BFHX) group (n = 66) and a placebo group (n = 65). BFHX or placebo was given orally three times a day (1.4 g/dose) for 90 days. The primary outcomes was to evaluate improvements in exercise tolerance and imaging manifestations on chest computed tomography (CT).
RESULTS


After the exclusion of two patients who withdrew prior to receiving any medications, 129 patients were recruited, including 64 patients in the BFHX group and 65 patients in the placebo group. After 3 months of treatment, the BFHX group exhibited greater attenuation of pneumonia lesions on chest CT than the placebo group (P<0.05). Improvements in 6-minute walk distance (6MWD) relative to baseline were also significantly better in the BFHX group than in the placebo group (P<0.01). Scores on the Fatigue Assessment Inventory (FAI) were lower in the BFHX group than in the placebo group (P<0.05). Although the rate of adverse events was higher in the BFHX group than in the placebo group (9.38% vs. 4.62%), the difference was not significant (P=0.3241).
CONCLUSIONS


BFHX may exert strong rehabilitative effects on physiological activity in patients recovering from COVID-19, which may in turn attenuate symptoms of fatigue and improve exercise tolerance.",2021,Scores on the Fatigue Assessment Inventory (FAI) were lower in the BFHX group than in the placebo group (P<0.05).,"['July 22, 2021, coronavirus disease 2019 (COVID-19) has infected more than 192 million people in a worldwide pandemic, with conservative estimates suggesting that there are more than 175 million convalescent patients with COVID-19', '129 patients were recruited, including 64 patients in the BFHX group and 65 patients in the placebo group', 'patients recovering from COVID-19', '131 patients in the rehabilitation period of COVID-19 infection', 'convalescent patients with COVID-19 infection']","['BFHX', 'Bufei Huoxue (BFHX', 'Bufei Huoxue capsules', 'traditional Chinese medicine (TCM', 'placebo', 'BFHX or placebo']","['6-minute walk distance (6MWD', 'exercise tolerance and imaging manifestations on chest computed tomography (CT', 'Fatigue Assessment Inventory (FAI', 'Efficacy and safety', 'rate of adverse events', 'attenuation of pneumonia lesions']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.268723,Scores on the Fatigue Assessment Inventory (FAI) were lower in the BFHX group than in the placebo group (P<0.05).,"[{'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Tingping', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Out-patient and Emergency, Wuhan Institute for Tuberculosis Control, Wuhan Pulmonary Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qi', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Xiangzhou District People's Hospital, Xiangyang, Hubei, China.""}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': 'Department of Respiratory, Third Hospital of Baotou City, Baotou, Inner Mongolia, China.'}, {'ForeName': 'Xiansheng', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, Hubei, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Wenju', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Bihua', 'Initials': 'B', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Lian', 'Affiliation': 'Department of Out-patient and Emergency, Wuhan Institute for Tuberculosis Control, Wuhan Pulmonary Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Haohao', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Xiangzhou District People's Hospital, Xiangyang, Hubei, China.""}, {'ForeName': 'Junping', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Respiratory, Third Hospital of Baotou City, Baotou, Inner Mongolia, China.'}, {'ForeName': 'Xuejiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, Hubei, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Dansha', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd., Hangzhou, Zhejiang, China.'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China. Electronic address: nanshan@vip.163.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China. Electronic address: jianwang1986@yahoo.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2021.114830']
2843,34763043,Exploring the pathogenesis of type 2 diabetes mellitus intestinal damp-heat syndrome and the therapeutic effect of Gegen Qinlian Decoction from the perspective of exosomal miRNA.,"ETHNOPHARMACOLOGICAL RELEVANCE


Diabetes is a common, complex, chronic metabolic disease. A randomized, double-blind, placebo-parallel controlled clinical study has shown that Gegen Qinlian Decoction (GQD) can reduce glycosylated hemoglobin in type 2 diabetes mellitus (T2DM) intestinal damp-heat syndrome patients in a dose-dependent manner.
AIM


To explore the pathogenesis of T2DM intestinal damp-heat syndrome and the therapeutic effect of GQD from the perspective of exosomal microRNA (miRNA).
METHODS


Eligible patients were selected and treated with GQD for 3 months to evaluate their clinical efficacy. Effective cases were matched with healthy volunteers, and saliva samples were collected. Exosomal miRNA was extracted from saliva and analyzed by chip sequencing. Subsequently, the function of the differential gene and the signal transduction pathway were analyzed using bioinformatics technology. Finally, three target miRNAs were randomly selected from the T2DM group/healthy group, and two target miRNAs in the T2DM before treatment/after treatment group were randomly selected for qPCR verification. Finally, we conducted a correlation analysis of the miRNAs and clinical indicators. The registration number for this research is ChiCTR-IOR-15006626.
RESULTS


(1) The expression of exosomal miRNA chips showed that there were 14 differentially expressed miRNAs in the T2DM group/healthy group, and 26 differentially expressed miRNAs in the T2DM before treatment/after treatment group. (2) Enrichment results showed that in the T2DM group/healthy group, it was primarily related to cell development, body metabolism, TGF-β, and ErbB signaling pathways. In the T2DM before treatment/after treatment group, it was mainly related to cellular metabolic regulation processes, and insulin, Wnt, and AMPK signaling pathways. (3) The qPCR verification showed that the expressions of hsa-miR-9-5p, hsa-miR-150-5p, and hsa-miR-216b-5p in the T2DM group was higher (P<0.05). Following GQD treatment, hsa-miR-342-3p and hsa-miR-221-3p were significantly downregulated (P<0.05). (4) hsa-miR-9-5p was positively correlated with BMI (P<0.05), and hsa-miR-150-5p was positively correlated with total cholesterol and triglycerides (P<0.05). The GQD efficacy-related gene hsa-miR-342-3p was positively correlated with the patient's initial blood glucose level (P<0.05), and hsa-miR-221-3p was positively correlated with total cholesterol and triglycerides (P<0.05).
CONCLUSION


The exosomal miRNA expression profile and signaling pathways related to T2DM intestinal damp-heat syndrome and the efficacy of GQD were established, which provides an alternative strategy for precision traditional Chinese medicine treatment.",2021,"Following GQD treatment, hsa-miR-342-3p and hsa-miR-221-3p were significantly downregulated (P<0.05).","['type 2 diabetes mellitus (T2DM) intestinal damp-heat syndrome patients in a dose-dependent manner', 'Eligible patients were selected and treated with']","['GQD', 'Gegen Qinlian Decoction', 'placebo', 'Gegen Qinlian Decoction (GQD']","['GQD efficacy-related gene hsa-miR-342-3p', ""patient's initial blood glucose level"", 'expression of exosomal miRNA chips', 'total cholesterol and triglycerides', 'cellular metabolic regulation processes, and insulin, Wnt, and AMPK signaling pathways', 'cell development, body metabolism, TGF-β, and ErbB signaling pathways', 'total cholesterol and triglycerides (P<0.05']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C2744779', 'cui_str': 'MIRN342 microRNA, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}]",,0.0241111,"Following GQD treatment, hsa-miR-342-3p and hsa-miR-221-3p were significantly downregulated (P<0.05).","[{'ForeName': 'LiSha', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Chengdu, 611137, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Bao', 'Affiliation': ""Graduate College, Beijing University of Chinese Medicine, Beijing, 100029, China; Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.""}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Graduate College, Beijing University of Chinese Medicine, Beijing, 100029, China; Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.""}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.""}, {'ForeName': 'Chengjuan', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'Shenzhen Hospital of Guang Zhou University of Chinese Medicine (Futian), Shenzhen, 518000, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Gansu University of Chinese Medicine, Lanzhou, 730000, China.'}, {'ForeName': 'Tiangang', 'Initials': 'T', 'LastName': 'Zhai', 'Affiliation': ""Graduate College, Beijing University of Chinese Medicine, Beijing, 100029, China; Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.""}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, 650000, China.'}, {'ForeName': 'Mengyi', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Linhua', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: melonzhao@163.com.""}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': 'Endocrinology Department, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, 130117, China. Electronic address: tongxiaolin66@126.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2021.114786']
2844,34762999,Mid-term Efficacy and Safety of Drug-coated Balloon versus Nitinol Bare Metal Stent for Primary Lesions in Femoropopliteal Artery Disease.,"OBJECTIVES


To compare drug-coated balloon (DCB) and bare metal stent (BMS) for primary lesions in femoropopliteal artery disease in Chinese population and to make subgroup analysis between the groups.
METHODS


Patients with primary lesions who underwent BMS or DCB treatment of a single tertiary vascular center were included and followed up for 24 months. Clinical and anatomic status were reported using the criteria recommended by the Society for Vascular Surgery. The primary endpoint included primary patency, clinically target limb revascularization, composite safety endpoint and all-cause death over 24 months assessed by Kaplan-Meier. Secondary endpoints included technical success rate and stent-related complications.
RESULTS


284 patients with 324 limbs were pooled into analysis and most of the baseline characteristics did not show significant difference. 74 in BMS group and 71 in DCB group were claudicants while 83 in BMS group and 56 in DCB group suffered from chronic limb threatening ischemia (CLTI). The mean cumulative lesion length was 18.7±9.8cm in BMS group while 17.2±10.3cm in DCB group. Kaplan-Meier estimates of primary patency were 75.3% and 80.9% for BMS and DCB groups at 12 months while decreased to 63.9% and 70.2% at 24 months (log-rank p=0.167), respectively. Freedom from clinically driven target limb revascularization was 86.8% and 92.7% for BMS and DCB groups at 12 months while dropped to 82.5% and 85.9% at 24 months (log-rank p=0.342). Estimates of primary patency between BMS and DCB group did not show significant difference on lesions with poor runoff (58.8% versus 67.3%, log-rank p=0.127), severe calcification (64.5% versus 69.4%, log-rank p=0.525) and popliteal artery involvement (59.3% versus 60.3%, log-rank p=0.695) at 24 months. The overall survival (92.6% for BMS, 90.3% for DCB, log-rank p=0.391) and freedom from composite safety endpoint (79.3% for BMS, 79.2% for DCB, log-rank p=0.941) showed no significant difference at 24 months.
CONCLUSIONS


Over the 24-month follow-up, BMS and DCB showed equivalent efficacy and safety outcomes for primary femoropopliteal artery disease, which indicated the reduction of permanent metallic implant insertion might be possible.",2021,"The overall survival (92.6% for BMS, 90.3% for DCB, log-rank p=0.391) and freedom from composite safety endpoint (79.3% for BMS, 79.2% for DCB, log-rank p=0.941) showed no significant difference at 24 months.
","['primary lesions in femoropopliteal artery disease in Chinese population', 'Patients with primary lesions who underwent BMS or DCB treatment of a single tertiary vascular center were included and followed up for 24 months', 'Primary Lesions in Femoropopliteal Artery Disease', '284 patients with 324 limbs']","['Drug-coated Balloon versus Nitinol Bare Metal Stent', 'BMS and DCB', 'drug-coated balloon (DCB) and bare metal stent (BMS', 'DCB']","['lesions with poor runoff', 'primary patency, clinically target limb revascularization, composite safety endpoint and all-cause death', 'limb revascularization', 'technical success rate and stent-related complications', 'overall survival', 'severe calcification', 'popliteal artery involvement', 'Kaplan-Meier estimates of primary patency', 'mean cumulative lesion length']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0852949', 'cui_str': 'Disorder of artery'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0472662', 'cui_str': 'Limb revascularization'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1720943', 'cui_str': 'Kaplan-Meier Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",324.0,0.0854107,"The overall survival (92.6% for BMS, 90.3% for DCB, log-rank p=0.391) and freedom from composite safety endpoint (79.3% for BMS, 79.2% for DCB, log-rank p=0.941) showed no significant difference at 24 months.
","[{'ForeName': 'Haocheng', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China.""}, {'ForeName': 'Xuemin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China.""}, {'ForeName': 'Qingle', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China.""}, {'ForeName': 'Jingjun', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China.""}, {'ForeName': 'Changshun', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China.""}, {'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China.""}, {'ForeName': 'Weihao', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China. Electronic address: taozhang@bjmu.edu.cn.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, West District, Beijing, 100044, P. R. China. Electronic address: rmyyxgwk@163.com.""}]",Annals of vascular surgery,['10.1016/j.avsg.2021.09.022']
2845,34762989,Superimposition of sequential scans to measure erosion on unpolished and curved human enamel.,"OBJECTIVES


To determine if superimposition of sequential scans can discriminate between different fluorides at step heights less than 5 μm on natural human enamel surfaces.
MATERIALS AND METHODS


Natural, unpolished, human enamel specimens (n = 60) were randomly assigned to one of three pre-treatment toothpaste slurries with a calcium silicate/fluoride, fluoride-only and a control. Baseline and post treatment scans, from a non-contacting profilometer with a 0.01 μm z-axis and <1 μm lateral scanning resolution were imported into superimposition software to define change in mean 3D step height and surface roughness following erosion in 0.3 % citric acid for 15 min. Statistical analysis conducted with two-way repeated measures ANOVA and post-hoc Tukey's multiple comparisons.
RESULTS


Confidence and resolution of superimposition and subtraction of repeated profiles from unpolished enamel revealed accuracy within 1-2 μm. The technique was able to discriminate between the fluorides demonstrating statistical differences in mean (SD) 3D step height (μm) of 1.96 (0.40) and 2.75 (0.49) (p=0.0024). There was a statistically significant increase in surface roughness for all groups after 15 min erosion compared to baseline. But no statistically significant difference between the interventions after 15 min erosion but there was compared to no fluoride (p=0.006).
CONCLUSION


Superimposition and subtraction of profiles could discriminate between fluoride interventions, which showed statistical differences in enamel loss differences less than 3 μm.
CLINICAL SIGNIFICANCE


This erosion model and data analysis workflow was able to distinguish differences between scans of 3 μm on unpolished enamel following the interaction with fluoride.",2021,There was a statistically significant increase in surface roughness for all groups after 15 min erosion compared to baseline.,"['Natural, unpolished, human enamel specimens (n\u202f=\u202f60']","['toothpaste slurries with a calcium silicate/fluoride, fluoride-only and a control']",['surface roughness'],"[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}]",60.0,0.0925206,There was a statistically significant increase in surface roughness for all groups after 15 min erosion compared to baseline.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mylonas', 'Affiliation': ""School of Dentistry, College of Biomedical and Life Sciences, Cardiff University, Heath Park, Cardiff CF14 4XY; Centre for Oral, Clinical &Translational Sciences, King's College London Faculty of Dentistry, Oral & Craniofacial Sciences, UK. Electronic address: mylonasp@cardiff.ac.uk.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Moazzez', 'Affiliation': ""Centre for Oral, Clinical &Translational Sciences, King's College London Faculty of Dentistry, Oral & Craniofacial Sciences, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Joiner', 'Affiliation': 'Unilever Oral Care, Bebington, Wirral, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': ""Centre for Oral, Clinical &Translational Sciences, King's College London Faculty of Dentistry, Oral & Craniofacial Sciences, UK.""}]",Journal of dentistry,['10.1016/j.jdent.2021.103879']
2846,34762980,Exploringpatterns of transcranial magnetic stimulation in improving sleep disorders in Alzheimer's disease patients.,"BACKGROUND


Sleep disorders are commonly comorbid with Alzheimer's disease (AD), And these disorders interfere with each other in many aspects. To date, pharmacological treatments for sleep disorders are still limited, and studies investigating repetitive transcranial magnetic stimulation (rTMS) for sleep disorders in AD are still lacking.
METHOD


A single-center, randomized, double-blind, parallel-arm, and sham-controlled pilot study was conducted in AD patients with sleep disorders. Seventy subjects were randomly divided into the following two groups: the sham group (SG) and the intervention group (IG). We evaluated sleep changes using the Pittsburgh Sleep Quality Index (PSQI) before and after the intervention. We also assessed the patients' cognitive function by the Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-Cog). The intervention period was four weeks, and the patients were followed up in the 8th week to test the persistence of the effect of the rTMS intervention.
RESULT


Significant differences in the PSQI scores were found between the SG and IG at the end of the 4-week intervention (P = 0.001) and the 8-week follow-up (P < 0.001). There was also significant improvement in ADAS-Cog scores (4 weeks: P = 0.048, 8 weeks: P = 0.038). Activities of daily living (ADL) did not significantly differ between the SG and IG.
CONCLUSION


rTMS can effectively ameliorate sleep disorders in AD patients.",2021,Significant differences in the PSQI scores were found between the SG and IG at the end of the 4-week intervention (P = 0.001) and the 8-week follow-up (P < 0.001).,"['AD patients with sleep disorders', 'Seventy subjects', 'AD patients', ""Alzheimer's disease patients""]","['rTMS intervention', 'transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'rTMS']","['Activities of daily living (ADL', 'PSQI scores', 'Pittsburgh Sleep Quality Index (PSQI', ""patients' cognitive function by the Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-Cog"", 'ADAS-Cog scores', 'sleep disorders']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}]",70.0,0.10001,Significant differences in the PSQI scores were found between the SG and IG at the end of the 4-week intervention (P = 0.001) and the 8-week follow-up (P < 0.001).,"[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Graduate School of Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China; Department of Neurology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China-Japan Friendship Hospital, Beijing, China; Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Department of Neurology, China-Japan Friendship Hospital, Beijing, China; Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Shuhong', 'Initials': 'S', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China.'}, {'ForeName': 'Dantao', 'Initials': 'D', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Graduate School of Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China; Department of Neurology, China-Japan Friendship Hospital, Beijing, China; Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China.'}]",Neuroscience letters,['10.1016/j.neulet.2021.136337']
2847,34763383,"Commentary on ""Comparative Study of Narrow-Band Imaging and i-scan for Predicting the Histology of Intermediate-to-Large Colorectal Polyps: A Prospective, Randomized Pilot Study"".",,2021,,['Intermediate-to-Large Colorectal Polyps'],['Narrow-Band Imaging and i-scan'],[],"[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}]","[{'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",[],,0.00580047,,"[{'ForeName': 'Yunho', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Endoscopy, The Jikei University Katsushika Medical Center, Tokyo, Japan.'}]",Clinical endoscopy,['10.5946/ce.2021.206']
2848,34763370,RESTING STATE LANGUAGE NETWORK NEUROPLASTICITY IN POST-STROKE MUSIC LISTENING: A RANDOMISED CONTROLLED TRIAL.,"Recent evidence suggests that post-stroke vocal music listening can aid language recovery, but the mechanisms of network-level functional neuroplasticity of this effect are unknown. Here, we sought to determine if improved language recovery observed after post-stroke listening to vocal music is driven by changes in longitudinal resting-state functional connectivity within the language network. Using data from a single-blind randomized controlled trial on stroke patients (N=38), we compared the effects of daily listening to self-selected vocal music, instrumental music, and audio books on changes of the resting state functional connectivity within the language network and their correlation to improved language skills and verbal memory during the first three months post-stroke. From acute to 3-month stage, the vocal music and instrumental music groups increased functional connectivity between a cluster comprising the left inferior parietal areas and the language network more than the audio book group. However, the functional connectivity increase correlated with improved verbal memory only in the vocal music group cluster. This study shows that listening to vocal music post-stroke promotes recovery of verbal memory by inducing changes in longitudinal functional connectivity in the language network. Our results conform to the variable neurodisplacement theory underpinning aphasia recovery.",2021,This study shows that listening to vocal music post-stroke promotes recovery of verbal memory by inducing changes in longitudinal functional connectivity in the language network.,['stroke patients (N=38'],"['daily listening to self-selected vocal music, instrumental music, and audio books']","['language skills and verbal memory', 'functional connectivity', 'verbal memory', 'language recovery']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0006002', 'cui_str': 'Book'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.160612,This study shows that listening to vocal music post-stroke promotes recovery of verbal memory by inducing changes in longitudinal functional connectivity in the language network.,"[{'ForeName': 'Aleksi J', 'Initials': 'AJ', 'LastName': 'Sihvonen', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Pitkäniemi', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Leo', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Soinila', 'Affiliation': 'Neurocenter, Turku University Hospital and Division of Clinical Neurosciences, University of Turku, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Särkämö', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland.'}]",The European journal of neuroscience,['10.1111/ejn.15524']
2849,34763338,Mannitol is comparable to hypertonic saline for raised intracranial pressure in Acute Liver Failure (MAHAL Study): A RCT.,"BACKGROUND


Raised intracranial pressure due to cerebral edema (CE) is central to development of hepatic encephalopathy in ALF. Mannitol (MT) & Hypertonic saline (HS) has been shown to improve CE. We compared the efficacy & safety of the two modalities Methods: ALF with CE were prospectively randomized in an open study to receive either 5 ml/kg of either 3% HS, as continuous infusion; titrated every 6 hourly to achieve serum sodium of <160(Group A; n=26) or 1 g/kg of 20% MN as a IV bolus, repeated every six hourly (Group B; n=25) in addition to standard ALF care. Primary end-point was reduction of intracranial pressure defined as optic nerve sheath diameter <5mm and middle cerebral arterial pulsatility index (PI) <1.2 at 12 hours.
RESULTS


Fifty-one patients with ALF, hepatitis E being commonest (33.3%), median jaundice to HE interval of 8(1-16) days, were randomized to HS (n=26) or MN (n=25). Baseline characteristics were comparable including King's college criteria [>2: 38.4% vs.40%]. Overall, 61.5% patients in HS and 56% in MN group showed reduction in ICP at 12 hr. (p=0.25). Rebound increase in ICP indices was noted in 5(20%) patients in MT and none in HS (p<0.05) group. New onset acute kidney injury was commoner in MT than HS group. The ICU stay, and 28-day transplant free survival were not different between the groups.
CONCLUSIONS


While both agents had comparable efficacy in reducing ICP and mortality in ALF patients was comparable, HS was significantly better in preventing reducing rebound CE with lower renal dysfunction.",2021,"The ICU stay, and 28-day transplant free survival were not different between the groups.
","['Fifty-one patients with ALF, hepatitis E being commonest (33.3%), median jaundice to HE interval of 8(1-16) days']","['HS', 'Mannitol', 'hypertonic saline', 'Mannitol (MT) & Hypertonic saline (HS']","['ICP', 'efficacy & safety', 'ICP and mortality', 'reduction of intracranial pressure defined as optic nerve sheath diameter <5mm and middle cerebral arterial pulsatility index (PI', 'ICU stay, and 28-day transplant free survival', 'ICP indices']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1431931', 'cui_str': 'ALF protein, human'}, {'cui': 'C0085293', 'cui_str': 'Viral hepatitis E'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",51.0,0.139551,"The ICU stay, and 28-day transplant free survival were not different between the groups.
","[{'ForeName': 'Chetan Ramesh', 'Initials': 'CR', 'LastName': 'Kalal', 'Affiliation': ''}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Maiwall', 'Affiliation': ''}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Choudhary', 'Affiliation': ''}, {'ForeName': 'Madhumita', 'Initials': 'M', 'LastName': 'Premkumar', 'Affiliation': ''}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Ashish Kumar', 'Initials': 'AK', 'LastName': 'Vyas', 'Affiliation': ''}, {'ForeName': 'Shiv Kumar', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': ''}]","Digestive diseases (Basel, Switzerland)",['10.1159/000520229']
2850,34763335,"Effects of Low-Volume, High-Intensity Interval Training Compared with Continuous Training on Regional and Global Body Composition in Adults with Metabolic Syndrome: A post hoc Analysis of a Randomized Clinical Trial.","OBJECTIVE


The aim of this study was to compare the effects of low-volume, high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT) on body composition in adults with metabolic syndrome (MS).
METHODS


This is a post hoc analysis of the randomized clinical trial Intraining-MET. Sixty adults (40-60 years old) were randomized to an MICT (n = 31) or HIIT (n = 29) supervised programme 3 days/week for 12 weeks. MICT sessions were conducted for 36 min at 60% of peak oxygen consumption (VO2peak). HIIT sessions included 6 intervals at 90% VO2peak for 1 min, followed by 2 min at 50% VO2peak. Body composition was assessed with dual energy X-ray absorptiometry.
RESULTS


Body weight did not change from pre- to post-training in either MICT (78.9 ± 15.6 kg; 77.7 ± 16.5 kg, p = 0.280) or HIIT groups (76.3 ± 13.4 kg; 76.3 ± 13.7 kg, p = 0.964). Body fat percentage and fat mass (FM) decreased post-training in the MICT (-0.9%; 95% confidence interval [CI]: -0.27 to -1.47 and -0.7 kg; 95% CI: -0.12 to -1.30) and HIIT groups (-1.0%; 95% CI: -0.32 to -1.68 and -0.8 kg; 95% CI: -0.17 to -1.47). Compared to the HIIT programme, MICT significantly reduced android FM (-0.14 kg; 95% CI: -0.02 to -0.26). Lean mass (LM) increased post-training in MICT (+0.7 kg; 95% CI: 0.01-1.41) and HIIT groups (+0.9 kg; 95% CI: 0.12-1.64), but only HIIT increased the trunk LM (+0.6 kg; 95% CI: 0.06-1.20).
CONCLUSIONS


Both MICT and HIIT reduced FM without changing body weight in adults with MS. MICT had additional benefits by reducing the android FM, whereas HIIT seemed to increase LM. Given the characteristics of the post hoc analysis, further research is required to confirm these results.",2021,Body fat percentage and fat mass (FM) decreased post-training in the MICT (-0.9%; 95% confidence interval [CI]:,"['adults with metabolic syndrome (MS', 'Sixty adults (40-60 years old', 'adults with MS', 'Adults with Metabolic Syndrome']","['low-volume, high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT', 'MICT', 'Low-Volume, High-Intensity Interval Training', 'MICT and HIIT reduced FM', 'Continuous Training']","['trunk LM', 'Body fat percentage and fat mass (FM', 'Regional and Global Body Composition', 'android FM', 'body composition', 'Body weight', 'Lean mass (LM', 'Body composition']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.0507643,Body fat percentage and fat mass (FM) decreased post-training in the MICT (-0.9%; 95% confidence interval [CI]:,"[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Aristizabal', 'Affiliation': 'Physiology and Biochemistry Research Group-PHYSIS, Faculty of Medicine, University of Antioquia, Medellín, Colombia.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Montoya', 'Affiliation': 'Physiology and Biochemistry Research Group-PHYSIS, Faculty of Medicine, University of Antioquia, Medellín, Colombia.'}, {'ForeName': 'Yeliana L', 'Initials': 'YL', 'LastName': 'Sánchez', 'Affiliation': 'Physiology and Biochemistry Research Group-PHYSIS, Faculty of Medicine, University of Antioquia, Medellín, Colombia.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Yepes-Calderón', 'Affiliation': 'Physiology and Biochemistry Research Group-PHYSIS, Faculty of Medicine, University of Antioquia, Medellín, Colombia.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Narvaez-Sanchez', 'Affiliation': 'Physiology and Biochemistry Research Group-PHYSIS, Faculty of Medicine, University of Antioquia, Medellín, Colombia.'}, {'ForeName': 'Jaime A', 'Initials': 'JA', 'LastName': 'Gallo-Villegas', 'Affiliation': 'Sports Medicine Postgraduate Program, and GRINMADE Research Group, Faculty of Medicine, University of Antioquia, Medellín, Colombia.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Calderón', 'Affiliation': 'Physiology and Biochemistry Research Group-PHYSIS, Faculty of Medicine, University of Antioquia, Medellín, Colombia.'}]",Annals of nutrition & metabolism,['10.1159/000518909']
2851,34763309,Effect of time-restricted feeding on body composition and cardio-metabolic risk in middle-aged women in Taiwan.,"OBJECTIVES


We sought to investigate the effects of time-restricted feeding (TRF) and a traditional weight-loss method on body composition and cardio-metabolic risk factors in middle-aged women.
METHODS


In a single-center, randomized, open-label, parallel-group design, women ages 40 to 65 y with body mass index ≥ 24 kg/m 2  or waist circumference > 80 cm were recruited. They were guided to a daily low-calorie diet of 1400 kcal and randomly assigned into a TRF group (limit 8 h of eating time and fasting for 16 h) or a non-TRF group (traditional weight-loss method, unrestricted eating time) for 8 wk. Body composition, blood pressure, blood biochemical variables, and insulin resistance status were measured before and after intervention.
RESULTS


Body weight, body mass index, waist circumference, and body fat mass decreased significantly in both groups after 8 wk of intervention (P < 0.05). Body weight decreased more in the TRF group than the non-TRF group (-4.1% ± 2.8% versus -2.4% ± 2.5%; P = 0.012), as did diastolic blood pressure (75.3 ± 11.2 mm Hg versus 70.5 ± 9.4 mm Hg; P = 0.012). There were no statistical differences between the two groups in total cholesterol, triacylglycerols, high- or low-density lipoprotein cholesterol, and fasting insulin level. However, fasting glucose and insulin resistance status increased significantly for the TRF group after the intervention (respectively, 88.3 ± 7.6 mg/dL versus 92.6 ± 9.6 mg/dL, P = 0.003; 1.7 ± 0.7 versus 2.1 ± 1.0, P = 0.048).
CONCLUSION


The weight loss and reduction in diastolic blood pressure using the TRF method were better than with the traditional weight-loss method. However, this method may increase fasting glucose levels and adverse insulin resistance status.",2021,The weight loss and reduction in diastolic blood pressure using the TRF method were better than with the traditional weight-loss method.,"['middle-aged women in Taiwan', 'women ages 40 to 65 y with body mass index ≥ 24 kg/m', ' 80 cm were recruited', 'middle-aged women']","['TRF', 'TRF group (limit 8 h of eating time and fasting for 16 h) or a non-TRF', 'time-restricted feeding (TRF) and a traditional weight-loss method', 'time-restricted feeding']","['total cholesterol, triacylglycerols, high- or low-density lipoprotein cholesterol, and fasting insulin level', 'Body composition, blood pressure, blood biochemical variables, and insulin resistance status', 'fasting glucose and insulin resistance status', '2  or waist circumference', 'body composition and cardio-metabolic risk factors', 'Body weight', 'fasting glucose levels and adverse insulin resistance status', 'weight loss and reduction in diastolic blood pressure', 'body composition and cardio-metabolic risk', 'Body weight, body mass index, waist circumference, and body fat mass', 'did diastolic blood pressure']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.00983594,The weight loss and reduction in diastolic blood pressure using the TRF method were better than with the traditional weight-loss method.,"[{'ForeName': 'Yan-Ju', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Department of Food and Nutrition, Tri-Service General Hospital, Taipei, Taiwan. Electronic address: jinstar6666@gmail.com.'}, {'ForeName': 'Yun-Ting', 'Initials': 'YT', 'LastName': 'Wang', 'Affiliation': 'Department of Food and Nutrition, Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Lin-Chien', 'Initials': 'LC', 'LastName': 'Chan', 'Affiliation': 'Department of Food and Nutrition, Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Nain-Feng', 'Initials': 'NF', 'LastName': 'Chu', 'Affiliation': 'Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan; School of Public Health, National Defense Medical Center, Taipei, Taiwan. Electronic address: chuepi369@gmail.com.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2021.111504']
2852,34763295,Yoga and Pilates compared to pelvic floor muscle training for urinary incontinence in elderly women: A randomised controlled pilot trial.,"BACKGROUND


and purpose: There is limited evidence from randomised controlled trials (RCTs) regarding the use of yoga and Pilates for the management of urinary incontinence (UI) in women. This study aims to investigate the preliminary effects of using Pilates and yoga to manage UI.
MATERIALS AND METHODS


An assessor-blinded, prospective, three-arm parallel-group randomised controlled pilot trial was conducted in three elderly care centres in Hong Kong. Thirty women aged 60 years or above were included in the study. Study centres were randomly assigned to each of the three interventions (yoga, Pilates and pelvic floor muscle training [PFMT; standard care control]). Study interventions were provided once a week for four weeks, followed by unsupervised CD-guided home exercises for eight weeks. Outcomes included the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), 1-h pad test, and feasibility measures such as adherence to the intervention programme, recruitment and retention rates and safety. Outcomes were assessed at baseline, 4 and 12 weeks. Statistical analysis was performed using two-way repeated measures analysis of covariance.
RESULTS


All three interventions demonstrated a statistically significant effect on ICIQ-SF scores from baseline to weeks 4 and 12. Significant effects in UI were reported for yoga compared with Pilates (mean: -2.93, 95% CI -5.35, -0.51; p = 0.02).
CONCLUSION


Yoga poses intended to address the pelvic floor and core muscles were found to have superior benefits over Pilates exercises in terms of improved continence measured with the ICIQ-SF.",2021,"Significant effects in UI were reported for yoga compared with Pilates (mean: -2.93, 95% CI -5.35, -0.51; p = 0.02).
","['urinary incontinence (UI) in women', 'Thirty women aged 60 years or above were included in the study', 'elderly women', 'three elderly care centres in Hong Kong']","['Pilates and yoga to manage UI', 'pelvic floor muscle training', 'Yoga and Pilates', 'three interventions (yoga, Pilates and pelvic floor muscle training [PFMT; standard care control']","['International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), 1-h pad test, and feasibility measures such as adherence to the intervention programme, recruitment and retention rates and safety', 'ICIQ-SF scores']","[{'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.107871,"Significant effects in UI were reported for yoga compared with Pilates (mean: -2.93, 95% CI -5.35, -0.51; p = 0.02).
","[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kannan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong. Electronic address: priya.kannan@polyu.edu.hk.'}, {'ForeName': 'Wai Hin', 'Initials': 'WH', 'LastName': 'Hsu', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Wai Tung', 'Initials': 'WT', 'LastName': 'Suen', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Lok Man', 'Initials': 'LM', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Ayelet', 'Initials': 'A', 'LastName': 'Assor', 'Affiliation': 'Stanley Wellness Centre, Central, Hong Kong.'}, {'ForeName': 'Chun Ming', 'Initials': 'CM', 'LastName': 'Ho', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101502']
2853,34763283,Increase in the left hippocampal dentate gyrus head volume after a 4-week bright light exposure in healthy participants: A randomized controlled study.,"INTRODUCTION


Bright light therapy (BLT) has been used for treating seasonal affective disorder, depression and bipolar depression. However, it's precise mechanism remains unclear. Bright light exposure (BL) induces neurogenesis in the adult rat hippocampal dentate gyrus (DG). We hypothesized that BL may induce neurogenesis in the human DG as well.
METHOD


A 4-week randomized controlled trial study was conducted, where healthy participants were randomly assigned to a BL group (10,000 lux) or dim light exposure group (DL group; 50 lux). Magnetic resonance imaging was performed at baseline and after 4 weeks. Longitudinal hippocampal subfield segmentation was generated via the FreeSurfer 7.1.1 hippocampal subfields module to evaluate volume of bilateral granule cell and molecular layer of the DG-head and -body.
RESULTS


Our final sample size was 20, which consisted of BL group (n = 10) and DL group (n = 10). After age and sex adjustment, significant effects of time and group were detected in the left DG-head volume (p = 0.04). In the BL group, the left DG-head volume significantly increased (p = 0.004), whereas no significant volumetric change was observed in the DL group.
CONCLUSIONS


This study revealed that 4-week BL significantly increased left DG-head volume in healthy participants. Thus, neurogenesis might be induced by BL in the human DG, which is a completely new mechanism of BLT.",2021,"In the BL group, the left DG-head volume significantly increased (p = 0.004), whereas no significant volumetric change was observed in the DL group.
","['adult rat hippocampal dentate gyrus (DG', 'healthy participants']","['BL group (10,000 lux) or dim light exposure', 'BL', 'Bright light exposure (BL', 'Bright light therapy (BLT', 'Magnetic resonance imaging']","['volumetric change', 'left DG-head volume']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0152314', 'cui_str': 'Structure of dentate gyrus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152314', 'cui_str': 'Structure of dentate gyrus'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0309167,"In the BL group, the left DG-head volume significantly increased (p = 0.004), whereas no significant volumetric change was observed in the DL group.
","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Neuropsychiatry, Oita University Faculty of Medicine, Oita, Japan. Electronic address: hira-hiro@oita-u.ac.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Terao', 'Affiliation': 'Department of Neuropsychiatry, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Hatano', 'Affiliation': 'Department of Neuropsychiatry, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Masanao', 'Initials': 'M', 'LastName': 'Shirahama', 'Affiliation': 'Department of Neuropsychiatry, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Kugimiya', 'Affiliation': 'Department of Neuropsychiatry, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kohno', 'Affiliation': 'Department of Neuropsychiatry, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Ishii', 'Affiliation': 'Department of Neuropsychiatry, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Matsuta', 'Affiliation': 'Department of Neurosurgery, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Shimomura', 'Affiliation': 'Hospital informatics center, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Fujiki', 'Affiliation': 'Department of Neurosurgery, Oita University Faculty of Medicine, Oita, Japan.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.11.009']
2854,34763274,"Comment on ""The direct comparison of inhaled versus intravenous levosimendan in children with pulmonary hypertension undergoing on-cardiopulmonary bypass cardiac surgery: A randomized, controlled, non-inferiority study"".",,2021,,['children with pulmonary hypertension undergoing on-cardiopulmonary bypass cardiac surgery'],['levosimendan'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}]",[],,0.163873,,"[{'ForeName': 'Honggang', 'Initials': 'H', 'LastName': 'Zang', 'Affiliation': 'Department of Anaesthesia, Gansu Provincial Hospital, Lanzhou 730000, Gansu, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Anaesthesia, Gansu Provincial Hospital, Lanzhou 730000, Gansu, China.'}, {'ForeName': 'Wanxia', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Department of Cardiology, Gansu Provincial Hospital, Lanzhou 730000, Gansu, China. Electronic address: 15009315694m@sina.cn.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110572']
2855,34763236,Injury characteristics and hemodynamics associated with guideline-compliant CPR in a pediatric porcine cardiac arrest model.,"BACKGROUND


Guidelines for depth of chest compressions in pediatric cardiopulmonary resuscitation (CPR) are based on sparse evidence.
OBJECTIVE


We sought to evaluate the performance of the two most widely recommended chest compression depth levels for pediatric CPR (1.5 in. and 1/3 the anterior-posterior diameter- APd) in a controlled swine model of asphyxial cardiac arrest.
METHODS


We executed a 2-group, randomized laboratory study with an adaptive design allowing early termination for overwhelming injury or benefit. Forty mixed-breed domestic swine (mean weight = 26 kg) were sedated, anesthetized and paralyzed along with endotracheal intubation and mechanical ventilation. Asphyxial cardiac arrest was induced with fentanyl overdose. Animals were untreated for 9 min followed by mechanical CPR with a target depth of 1.5 in. or 1/3 the APd. Advanced life support drugs were administered IV after 4 min of basic resuscitation followed by defibrillation at 14 min. The primary outcomes were return of spontaneous circulation (ROSC), hemodynamics and CPR-related injury severity.
RESULTS


Enrollment in the 1/3 APd group was stopped early due to overwhelming differences in injury. Twenty-three animals were assigned to the 1.5 in. group and 15 assigned to the 1/3 APd group, per an adaptive group design. The 1/3 APd group had increased frequency of rib fracture (6.7 vs 1.7, p < 0.001) and higher proportions of several anatomic injury markers than the 1.5 in. group, including sternal fracture, hemothorax and blood in the endotracheal tube (p < 0.001). ROSC and hemodynamic measures were similar between groups.
CONCLUSION


In this pediatric model of cardiac arrest, chest compressions to 1/3APd were more harmful without a concurrent benefit for resuscitation outcomes compared to the 1.5 in. compression group.",2021,"The 1/3 APd group had increased frequency of rib fracture (6.7 vs 1.7, p < 0.001) and higher proportions of several anatomic injury markers than the 1.5 in.","['pediatric CPR (1.5\xa0in. and 1/3 the anterior-posterior diameter- APd) in a controlled swine model of asphyxial cardiac arrest', 'pediatric cardiopulmonary resuscitation (CPR', 'Forty mixed-breed domestic swine (mean weight\xa0=\xa026\xa0kg']",['endotracheal intubation and mechanical ventilation'],"['frequency of rib fracture', 'several anatomic injury markers', 'ROSC and hemodynamic measures', 'return of spontaneous circulation (ROSC), hemodynamics and CPR-related injury severity', 'sternal fracture, hemothorax and blood in the endotracheal tube']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0043603', 'cui_str': 'pamidronate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0006159', 'cui_str': 'Breeding'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0238436', 'cui_str': 'Fracture of sternum'}, {'cui': 'C0019123', 'cui_str': 'Hemothorax'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}]",23.0,0.0679175,"The 1/3 APd group had increased frequency of rib fracture (6.7 vs 1.7, p < 0.001) and higher proportions of several anatomic injury markers than the 1.5 in.","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Salcido', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: salcidodd@upmc.edu.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Koller', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Genbrugge', 'Affiliation': 'Emergency Department, University Hospitals Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Ericka L', 'Initials': 'EL', 'LastName': 'Fink', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Berg', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia and University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.""}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Menegazzi', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.10.030']
2856,34763175,Respiratory muscle training program supplemented by a cell-phone application in COPD patients with severe airflow limitation.,"PURPOSE


The purpose of this study was to implement a respiratory muscle training program through a mobile phone application for COPD patients with severe airflow limitation.
METHODS


We conducted an experimental study to determine the efficacy of a six-month mobile phone application. At least three times a week for six months the patients would participate in an online training session. We evaluated the lung volumes, maximal inspiratory and expiratory pressure (MIP/MEP) and diaphragm amplitude. The tests were performed at the beginning and at the end of the study.
RESULTS


Thirty-four patients with severe COPD, aged between 44 and 67 years (Mean ± SD, 59.29 ± 6.063), accepted to follow a rehabilitation program based on the use of the Pneumocontrol application. We observed on increased of MEP from the pre-rehabilitation state (83.41 cmH2O) to the post-rehabilitation state (95.03 cmH2O), z = 5.087, p < 0.001. Also, the median MIP significantly increased from the pre-rehabilitation state to the post-rehabilitation state, z = 5.052, p < 0.001. Diaphragmatic distance also increased from 2.81 cm to 3.44 cm, z = 5.069, p < 0.001.
CONCLUSION


Respiratory muscle training supplemented through a cell phone-based application can improve respiratory muscle strength and diaphragm mobility.",2021,"Diaphragmatic distance also increased from 2.81 cm to 3.44 cm, z = 5.069, p < 0.001.
","['COPD patients with severe airflow limitation', 'Thirty-four patients with severe COPD, aged between 44 and 67 years (Mean\xa0±\xa0SD, 59.29\xa0±\xa06.063), accepted to follow a rehabilitation program based on the use of the Pneumocontrol application']","['respiratory muscle training program', 'Respiratory muscle training program supplemented by a cell-phone application']","['median MIP', 'Diaphragmatic distance', 'lung volumes, maximal inspiratory and expiratory pressure (MIP/MEP) and diaphragm amplitude', 'respiratory muscle strength and diaphragm mobility']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1136359', 'cui_str': 'Cellular Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",34.0,0.0095753,"Diaphragmatic distance also increased from 2.81 cm to 3.44 cm, z = 5.069, p < 0.001.
","[{'ForeName': 'Barata Paula', 'Initials': 'BP', 'LastName': 'Irina', 'Affiliation': '""Vasile Goldis"" University of Arad, Faculty of Medicine, Department of Physiology, Arad, Romania.'}, {'ForeName': 'Marc Monica', 'Initials': 'MM', 'LastName': 'Steluta', 'Affiliation': 'University of Medicine and Pharmacy ""Victor Babes"" Timisoara, Department of Pulmonology, Timisoara, Romania. Electronic address: stel.marc@gmail.com.'}, {'ForeName': 'Tudorache', 'Initials': 'T', 'LastName': 'Emanuela', 'Affiliation': 'University of Medicine and Pharmacy ""Victor Babes"" Timisoara, Department of Pulmonology, Timisoara, Romania.'}, {'ForeName': 'Manolescu', 'Initials': 'M', 'LastName': 'Diana', 'Affiliation': 'University of Medicine and Pharmacy ""Victor Babes"" Timisoara, Radiology Department, Timisoara, Romania.'}, {'ForeName': 'Olar Dana', 'Initials': 'OD', 'LastName': 'Cristina', 'Affiliation': '""Vasile Goldis"" University of Arad, Faculty of Medicine, Department of Physiology, Arad, Romania.'}, {'ForeName': 'Frandes', 'Initials': 'F', 'LastName': 'Mirela', 'Affiliation': 'University of Medicine and Pharmacy ""Victor Babes"" Timisoara, Department of Biostatistics and Medical Informatics, Timisoara, Romania.'}, {'ForeName': 'Oancea', 'Initials': 'O', 'LastName': 'Cristian', 'Affiliation': 'University of Medicine and Pharmacy ""Victor Babes"" Timisoara, Department of Pulmonology, Timisoara, Romania.'}]",Respiratory medicine,['10.1016/j.rmed.2021.106679']
2857,34763652,The effectiveness of intervention based on the transactional model on improving coping efforts and stress moderators in hemodialysis patients in Tehran: a randomized controlled trial.,"BACKGROUND


Present study was conducted to determine the effect of training on coping efforts and stress moderators, based on transactional model of Lazarus and Folkman, in hemodialysis patients.
METHODS


This is a randomized controlled clinical trial on 116 hemodialysis patients referred to dialysis centers in Tehran from May to August 2018. The patients were assigned to two experimental and control groups using a simple randomization method. The intervention included 6 training sessions in the form of coping efforts and moderators of transactional model. Data were collected before and 3 months after the intervention. Data were analyzed using SPSS 16.
RESULTS


After 3 months training intervention, there was significant increase in the intervention group in the mean scores of coping efforts (P < 0.001), moderators and subscales of emotional regulation from 51.18 ± 20.42 to 64.87 ± 13.18 (P < 0.001), dispositional coping style from 45.56 ± 19.45 to 55.84 ± 18.03 and social support from 49.61 ± 20.14 to 55.55 ± 17.35 (P < 0.005).
CONCLUSION


The training based on transactional model was successful in the increase of social support, dispositional coping style and emotional regulation in hemodialysis patients. Therefore, Nurses and healthcare providers can use this program to help hemodialysis patients to increase their adaptation to the illness and reduce stress.
TRIAL REGISTRATION


IRCT registration number: IRCT20180524039814N1 ; Registration date: 13-08-2018; Registration timing: retrospectively registered: Last update: 13-08-2018.",2021,"The training based on transactional model was successful in the increase of social support, dispositional coping style and emotional regulation in hemodialysis patients.","['hemodialysis patients', '116 hemodialysis patients referred to dialysis centers in Tehran from May to August 2018', 'hemodialysis patients in Tehran']",[],"['social support, dispositional coping style and emotional regulation', 'moderators and subscales of emotional regulation', 'mean scores of coping efforts', 'dispositional coping style']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],"[{'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",116.0,0.0249387,"The training based on transactional model was successful in the increase of social support, dispositional coping style and emotional regulation in hemodialysis patients.","[{'ForeName': 'Mohtasham', 'Initials': 'M', 'LastName': 'Ghaffari', 'Affiliation': 'Environmental and Occupational Hazards Control Research Center, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Morowatisharifabad', 'Affiliation': 'Health Department, School of Public Health, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammad Saeed', 'Initials': 'MS', 'LastName': 'Jadgal', 'Affiliation': 'Tropical and communicable diseases research center, Iranshahr University of Medical Sciences and health services, Iranshahr, Iran.'}, {'ForeName': 'Yadollah', 'Initials': 'Y', 'LastName': 'Mehrabi', 'Affiliation': 'School of public health and safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Alizadeh', 'Affiliation': 'Health Department, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran. alizade2009@yahoo.com.'}]",BMC nephrology,['10.1186/s12882-021-02592-8']
2858,34763638,Comparative characteristics of a pacemaker implantation after biatrial or left atrial ablation of atrial fibrillation in combination with coronary artery bypass grafting in patients with ischemic heart disease and long-standing persistent atrial fibrillation.,"Aim      To compare the incidence of a permanent pacemaker (PP) implantation based on the chosen treatment technology (biatrial ablation, BA, or left atrial ablation (LAA) for long-standing persistent atrial fibrillation (AF) with simultaneous coronary bypass (CB).Material and methods  The study included 116 patients with long-standing persistent AF and indications for CB. Patients were randomized to two equal groups (58 patients in each). Group 1 underwent BA in combination with CB; group 2 patients underwent isolated LAA with simultaneous CB under the conditions of artificial circulation. Incidence of PP implantation was assessed during the early (to 30 days) and late (to 60 months) postoperative periods.Results For the observation period, a total of 9 PPs was implanted in both groups, 6 in the BA group and 3 in the LAA group (odds ratio, OR, 0.5; 95 % confidence interval, CI, 0.1-2.4; р=0.490). During the early postoperative period, 5 patients in the BA group and 2 patients in the LAA group were implanted with PP (OR, 0.4; 95 % CI. 0-2.5; р=0.438). During the late postoperative period, one (2%) patient of the BA group was implanted with a permanent PP at 30 months of follow-up due to the development of sick sinus syndrome (SSS); also, one (2%) patient of the LAA group required PP implantation at 54 months of follow-up due to the development of SSS. The causes for PP implantation in the BA group included the development of complete atrioventricular (AV) block in 9 % of cases (95 % CI, 4-19 %); sinus node dysfunction and junctional rhythm in 2 % of cases (95 % CI, 0-9 %). Compared to this group, the LAA group showed a statistically significant difference in the incidence of AV block (0 cases, р=0.047). The major cause for PP implantation in the LAA group was the development of sinus node dysfunction in 3 (5 %) patients (95 % CI, 2-14 %).Conclusion      The use of BA in surgical treatment of long-standing persistent AF with simultaneous myocardial revascularization is associated with a high risk of AV block, which requires permanent PP implantation in the postoperative period. Total incidence of permanent PP implantation for dysfunction of the cardiac conduction system following the combination surgical treatment of long-standing persistent AF and IHD, either CB and LAA or BA, did not differ between the treatment groups both in early and late postoperative periods.",2021,"Compared to this group, the LAA group showed a statistically significant difference in the incidence of AV block (0 cases, р=0.047).","['patients with ischemic heart disease and long-standing persistent atrial fibrillation', '116 patients with long-standing persistent AF and indications for CB']","['LAA', 'isolated LAA with simultaneous CB', 'simultaneous coronary bypass (CB).Material and methods', 'BA in combination with CB', 'permanent pacemaker (PP) implantation based on the chosen treatment technology (biatrial ablation, BA, or left atrial ablation (LAA', 'pacemaker implantation after biatrial or left atrial ablation of atrial fibrillation in combination with coronary artery bypass grafting']","['sinus node dysfunction and junctional rhythm', 'PP implantation', 'sinus node dysfunction', 'incidence of AV block', 'development of complete atrioventricular (AV) block', 'total of 9 PPs', 'Incidence of PP implantation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0428908', 'cui_str': 'Sinus node dysfunction'}, {'cui': 'C0232208', 'cui_str': 'AV junctional rhythm'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004245', 'cui_str': 'Atrioventricular block'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0151517', 'cui_str': 'Complete atrioventricular block'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",116.0,0.0342247,"Compared to this group, the LAA group showed a statistically significant difference in the incidence of AV block (0 cases, р=0.047).","[{'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Kalybekova', 'Affiliation': 'National medical research center named after academician E.N. Meshalkin, Novosibirsk.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Rakhmonov', 'Affiliation': 'National medical research center named after academician E.N. Meshalkin, Novosibirsk.'}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Lukinov', 'Affiliation': 'Institute of computational mathematics and mathematical geophysics, Novosibirsk.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Chernyavsky', 'Affiliation': 'National medical research center named after academician E.N. Meshalkin, Novosibirsk.'}]",Kardiologiia,['10.18087/cardio.2021.10.n1513']
2859,34763615,Therapist in-session feelings predict change in depressive symptoms in interpersonal and brief relational psychotherapy.,"Objective:  Brief Relational Therapy (BRT) includes the idea that the therapists use their in-session feelings in meta-communications about the therapy relationship to facilitate resolution of alliance ruptures. The current study aimed to explore the effect of therapist feelings on patient depressive symptoms in BRT compared to Interpersonal Psychotherapy (IPT). Methods:  The effects of therapist feelings were studied in 40 patients randomized to 16 sessions of IPT or BRT, using the Feeling Word Checklist-24, the Patient Health Questionnaire-9 and the Working Alliance Inventory. Data was analyzed using dynamic structural equation modeling. Results:  Negative therapist feelings predicted increase and positive feelings decrease in next-session PHQ-9 via the alliance and the patients' engaged feelings, in both treatments. The direct effect of negative therapist feelings on PHQ-9 differed significantly between BRT and IPT, with more negative feelings predicting a decrease in PHQ-9 in BRT but not in IPT. Conclusion:  Negative therapist feelings may cause increase/less decrease and positive feelings more decrease in depressive symptoms via disruptions in the alliance. In BRT, if the alliance is unaffected by negative therapist feelings, the patient's depressive symptoms may improve. Findings need replication in a larger sample.",2021,"Negative therapist feelings predicted increase and positive feelings decrease in next-session PHQ-9 via the alliance and the patients' engaged feelings, in both treatments.",['40 patients randomized to 16 sessions of'],"['Interpersonal Psychotherapy (IPT', 'IPT or BRT', 'Brief Relational Therapy (BRT']","['PHQ-9 in BRT', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",40.0,0.0263602,"Negative therapist feelings predicted increase and positive feelings decrease in next-session PHQ-9 via the alliance and the patients' engaged feelings, in both treatments.","[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Falkenström', 'Affiliation': 'Department of Psychology, Linnaeus University, Växjö, Sweden.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Holmqvist', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2021.1998700']
2860,34763599,Effect of heat stable carbetocin vs oxytocin for preventing postpartum haemorrhage on post delivery hemoglobin-a randomized controlled trial.,"OBJECTIVE


To compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level.
SETTING


Hospital based study in Southern India.
POPULATION


Women delivering vaginally who were enrolled in the WHO CHAMPION trial in a single facility in India. WHO CHAMPION Trial was a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin with oxytocin administered immediately after vaginal birth in women across 23 sites in 10 countries.
METHODS


This was a nested randomized controlled trial designed to compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM, administered within one minute of vaginal delivery of the baby for prevention of postpartum hemorrhage, on post-delivery 48-72 h hemoglobin level, adjusted for pre-delivery hemoglobin level. 1,799 women from one hospital in India participated in this study.
RESULTS


Pre-delivery hemoglobin and postpartum blood loss were not significantly different between carbetocin and oxytocin. Post-delivery hemoglobin, unadjusted or adjusted for pre-delivery hemoglobin, was slightly lower for carbetocin (10.09 g/dL) compared to oxytocin (10.21) (p value of 0.0432). The drop in hemoglobin was slightly higher for carbetocin, although the difference was very small (1.2 g/dL for carbetocin, 1.1 g/dL for oxytocin) ( p  value of .0786). The proportion of participants with a drop in hemoglobin of 2 g/dL or more, adjusted for pre-delivery hemoglobin, was higher for carbetocin (RR = 1.29, 95% CI 1.02-1.63). From the regression coefficients it can be derived that post-delivery hemoglobin, adjusted for pre-delivery hemoglobin, decreases on average 0.12 g/dL for each dL of blood lost, for the two treatments combined.
CONCLUSION


The present ancillary study showed that intramuscular administration of 100 µg of heat stable carbetocin can result in a slightly lower post-delivery hemoglobin, slightly higher drop and higher percentage of women having a drop of 2 g/dL or larger, compared to 10 IU of oxytocin.",2021,"The drop in hemoglobin was slightly higher for carbetocin, although the difference was very small (1.2 g/dL for carbetocin, 1.1 g/dL for oxytocin) ( p  value of .0786).","['1,799 women from one hospital in India participated in this study', 'Women delivering vaginally who were enrolled in the WHO CHAMPION trial in a single facility in India', 'Hospital based study in Southern India', 'women across 23 sites in 10 countries']","['intramuscular injections of heat-stable carbetocin with oxytocin', 'oxytocin', 'heat-stable carbetocin 100\u2009μg IM versus oxytocin', 'heat stable carbetocin vs oxytocin']","['postpartum haemorrhage', 'Pre-delivery hemoglobin and postpartum blood loss', 'hemoglobin']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0054670', 'cui_str': 'carbetocin'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",1799.0,0.155736,"The drop in hemoglobin was slightly higher for carbetocin, although the difference was very small (1.2 g/dL for carbetocin, 1.1 g/dL for oxytocin) ( p  value of .0786).","[{'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Vernekar', 'Affiliation': ""Women's and Children's Health Research Unit, J N Medical College, KLE Academy of Higher Education and Research, Belagavi, India.""}, {'ForeName': 'Swati S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': 'Obstetrics and Gynaecology, Amrita Institute of Medical Sciences, Kochi, India.'}, {'ForeName': 'Mrityunjay', 'Initials': 'M', 'LastName': 'Metgud', 'Affiliation': ""Women's and Children's Health Research Unit, J N Medical College, KLE Academy of Higher Education and Research, Belagavi, India.""}, {'ForeName': 'Yeshita V', 'Initials': 'YV', 'LastName': 'Pujar', 'Affiliation': ""Women's and Children's Health Research Unit, J N Medical College, KLE Academy of Higher Education and Research, Belagavi, India.""}, {'ForeName': 'Manjunath S', 'Initials': 'MS', 'LastName': 'Somannavar', 'Affiliation': ""Women's and Children's Health Research Unit, J N Medical College, KLE Academy of Higher Education and Research, Belagavi, India.""}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Piaggio', 'Affiliation': 'Statistika Consultoria, Campinas, Brazil.'}, {'ForeName': 'José Ferreira D E', 'Initials': 'JFDE', 'LastName': 'Carvalho', 'Affiliation': 'Statistika Consultoria, Campinas, Brazil.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Revankar', 'Affiliation': ""Women's and Children's Health Research Unit, J N Medical College, KLE Academy of Higher Education and Research, Belagavi, India.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Althabe', 'Affiliation': 'Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Widmer', 'Affiliation': 'Maternal and Perinatal Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Ahmet Metin', 'Initials': 'AM', 'LastName': 'Gulmezoglu', 'Affiliation': 'Concept Foundation, Geneva, Switzerland.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""Women's and Children's Health Research Unit, J N Medical College, KLE Academy of Higher Education and Research, Belagavi, India.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2021.2001799']
2861,34763594,Microbubble contrast agent SonoVue combined with oxytocin improves the efficiency of high-intensity focused ultrasound ablation for adenomyosis.,"BACKGROUND


To investigate the combined enhancing effects of microbubble-contrast SonoVue and oxytocin on high-intensity focused ultrasound (HIFU) ablation of adenomyosis.
METHODS


330 patients with adenomyosis were randomly assigned to SonoVue and oxytocin group (group A,  n  = 82), oxytocin (group B,  n  = 85), SonoVue (group C,  n  = 81), or the control (group D,  n  = 82) for HIFU ablation. In group A, oxytocin was dripped 0.32 IU/min, and HIFU ablation was started one minute after SonoVue injection. In group B, oxytocin was dripped 0.32 IU/min during ablation. In group C, HIFU ablation was started one minute after SonoVue injection. In group D, neither oxytocin nor SonoVue was applied. The clinical data, treatment results, and complications were analyzed.
RESULTS


All participants underwent HIFU treatment safely, and the mean energy efficiency factor (EEF) in the four groups was 4.7 ± 0.9J/mm 3 , 8.5 ± 0.6J/mm 3 , 8.9 ± 0.7J/mm 3 , and 12.6 ± 1.8J/mm 3 , respectively, with the mean ablation time (AT) of 633.7 ± 55.1 s, 874.2 ± 65.6 s, 936.3 ± 85.2 s, and 1103.2 ± 96.2 s, respectively. The non-perfused volume ratios (NPVR) were 90.4 ± 8.8%, 88.7 ± 9.1%, 89.4 ± 7.2%, 80.5 ± 7.9%, respectively. In addition, EEF and AT were the shortest in group A ( p  < 0.05). NPVR was significantly higher in group A than in the control group D ( p  < 0.05). The incidence rates of adverse events were not significantly different in the four groups ( p  > 0.05).
CONCLUSIONS


Compared to the control group, oxytocin combined with SonoVue in HIFU for adenomyosis can significantly decrease the energy and time needed for the ablation and safely enhance the treatment efficiency by improving the cavitation and heating of HIFU ablation and increasing the non-perfused volume ratio.",2021,"The incidence rates of adverse events were not significantly different in the four groups ( p  > 0.05).
",['330 patients with adenomyosis'],"['oxytocin', 'SonoVue and oxytocin', 'microbubble-contrast SonoVue and oxytocin', 'HIFU ablation']","['incidence rates of adverse events', 'NPVR', 'HIFU ablation', 'energy and time needed for the ablation and safely enhance the treatment efficiency', 'mean energy efficiency factor (EEF']","[{'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341858', 'cui_str': 'Endometriosis of uterus'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0964361', 'cui_str': 'SonoVue'}, {'cui': 'C1258018', 'cui_str': 'Microbubbles'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C2348970', 'cui_str': 'High intensity focused ultrasound ablation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2348970', 'cui_str': 'High intensity focused ultrasound ablation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",330.0,0.0435908,"The incidence rates of adverse events were not significantly different in the four groups ( p  > 0.05).
","[{'ForeName': 'Ruihong', 'Initials': 'R', 'LastName': 'Yao', 'Affiliation': 'Medical Imaging Department, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Medical Imaging Department, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Bulang', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': 'Medical Imaging Department, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Medical Imaging Department, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Medical Imaging Department, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}]","International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group",['10.1080/02656736.2021.1993357']
2862,34763587,Hospitalization costs with degludec versus glargine U100 for patients with type 2 diabetes at high cardiovascular risk: Canadian costs applied to SAEs from a randomized outcomes trial.,"OBJECTIVES


The present cost-consequence analysis compared estimated hospitalization costs in a Canadian setting with insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) in patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk.
METHODS


Medical terms were mapped across the different vocabularies, in order to assign unit costs from eligible hospital abstracts in Canadian Institute for Health Information data (International Statistical Classification of Diseases and Related Health Problems, 10 th  Revision, Canada) to serious adverse events (SAEs; Medical Dictionary for Regulatory Activities) from the randomized DEVOTE trial comparing the two insulins degludec and glargine. Mean annual costs of SAE-related hospitalizations were estimated by treatment, the cost difference (degludec - glargine U100) was bootstrapped to compute confidence intervals (CIs) and  p -values, and the cost ratio (degludec/glargine U100) was estimated using a Tweedie distribution.
RESULTS


The mean annual cost per patient for SAE-related hospitalizations was 4074 CAD with degludec and 4569 CAD with glargine U100 (cost difference: -495, 95% confidence interval [CI]: -966;-24,  p  = 0.039), for a cost ratio of 0.89 (95% CI: 0.81;0.98,  p  = 0.016). Overall, cost ratios from sensitivity analyses varying individual methodological assumptions were consistent with the main analysis. Of the system organ classes from DEVOTE SAEs,  cardiac disorders  were the largest contributor to the costs savings with degludec versus glargine U100.
CONCLUSIONS


In patients with T2D at high CV risk, our findings suggest that there are likely to be lower hospitalization costs with degludec versus glargine U100 based on the SAEs observed in DEVOTE and in a Canadian setting.",2021,"-966;-24,  p  = 0.039), for a cost ratio of 0.89 (95% CI: 0.81;0.98,  p  = 0.016).","['patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk', 'Medical terms were mapped across the different vocabularies, in order to assign unit costs from eligible hospital abstracts in Canadian Institute for Health Information data (International Statistical Classification of Diseases and Related Health Problems, 10 th  Revision, Canada) to serious adverse events (SAEs; Medical Dictionary for Regulatory Activities', 'patients with T2D at high CV risk', 'patients with type 2 diabetes at high cardiovascular risk']","['insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100', 'glargine', 'glargine U100']","['hospitalization costs', 'mean annual cost per patient for SAE-related hospitalizations', 'Hospitalization costs', 'Mean annual costs of SAE-related hospitalizations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012113', 'cui_str': 'Dictionary, Medical'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.27872,"-966;-24,  p  = 0.039), for a cost ratio of 0.89 (95% CI: 0.81;0.98,  p  = 0.016).","[{'ForeName': 'Jean-Eric', 'Initials': 'JE', 'LastName': 'Tarride', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Ted Rogers Centre for Heart Research, Toronto General Hospital Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Andersen', 'Affiliation': 'Biostatistics GLP-1 and CV 1, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gundgaard', 'Affiliation': 'GEPA early asset strategy, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Luckevich', 'Affiliation': 'Patient access, Novo Nordisk Canada Inc., Mississauga, Ontario, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mark', 'Affiliation': 'Biostatistics Degludec, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Wagner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}]",Journal of medical economics,['10.1080/13696998.2021.2003804']
2863,34763558,Investigating the Feasibility of Multisensory Environments to Improve the Assisted Bathing Experience for Veterans With Dementia: A Clinical Trial.,"OBJECTIVES


This evidence-based design clinical trial assessed the feasibility of a multisensory environment (MSE) using aromatherapy, color-changing lights, and music as a behavioral intervention to calm  Veterans  with dementia during assisted bathing to improve the patient experience.
BACKGROUND


The number of Veterans with dementia is growing rapidly, along with the associated debilitating behavior challenges. The severity of these distressed behaviors that predominantly occur at bath time often necessitates costly, dangerous sedatives. Feasibility studies of nonpharmacological behavioral interventions during bathing for people with dementia are urgently needed, and research supports MSE as a viable solution.
METHOD


Using an A-B, multiple baselines across participants design, this study tracked operational behaviors of four Veterans with dementia during bathing without and with an MSE intervention. Sessions were provided and recorded by a dedicated team of five nurses, so the study team could analyze the Veterans' operational behaviors to understand the impact of individualized MSE during both baseline and intervention phases.
RESULTS


The results support the feasibility of MSE as a helpful, nonpharmacological behavioral intervention for Veterans with dementia during bathing. All participants experienced an overall increase in duration of positive operational behaviors and an overall decrease in duration of negative operational behaviors.
CONCLUSIONS


Healthcare environments are integral components in dementia care and the use of MSE within the bathing setting appears to improve not only operational behaviors but the overall bathing experience.",2021,"The results support the feasibility of MSE as a helpful, nonpharmacological behavioral intervention for Veterans with dementia during bathing.","['Veterans With Dementia', 'people with dementia', 'Veterans with dementia during bathing without and with an MSE intervention', 'Veterans with dementia during bathing']","['MSE', 'nonpharmacological behavioral interventions', 'Multisensory Environments', 'multisensory environment (MSE) using aromatherapy, color-changing lights, and music as a behavioral intervention']","['duration of negative operational behaviors', 'duration of positive operational behaviors']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",5.0,0.108191,"The results support the feasibility of MSE as a helpful, nonpharmacological behavioral intervention for Veterans with dementia during bathing.","[{'ForeName': 'Lesa', 'Initials': 'L', 'LastName': 'Lorusso', 'Affiliation': 'Gresham Smith, Nashville, TN, USA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Bosch', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Nam-Kyu', 'Initials': 'NK', 'LastName': 'Park', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Shorr', 'Affiliation': 'Geriatric Research Education and Clinical Center, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Conroy', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Ahrentzen', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Magaly', 'Initials': 'M', 'LastName': 'Freytes', 'Affiliation': 'Center of Innovation on Disability & Rehabilitation Research, Gainesville, FL, USA.'}]",HERD,['10.1177/19375867211053861']
2864,34744066,Effects of a WeChat-based individualized post-discharge rehabilitation program on patients with lumbar fusion surgery.,"BACKGROUND


Exercise training after lumbar fusion surgery (LFS) is important for regaining the strength in the spinal muscles, pain management, and minimizing dysfunction. It may be prudent to evaluate technologies such as web-based chat and social media apps for increasing the efficacy of post-surgery interventions in LFS patients.
OBJECTIVE


To explore the effectiveness of a WeChat-based individualized post-discharge rehabilitation program in patients with LFS.
METHODS


Seventy-two eligible discharged LFS patients were enrolled from October 2018 to February 2019. The experimental group (36 cases) received a 10-week WeChat-based individualized rehabilitation program, while the control group (36 cases) received routine follow-up guidance. The outcomes were measured using the Exercise Compliance Questionnaire, Numerical Rating Scale, Oswestry Disability Index and Chinese version of the self-efficacy for exercise scale.
RESULTS


The analysis using generalized estimation equations method shows significant differences in the interaction effect of group*time in exercise compliance (Wald c2= 7.459, P< 0.05), group effect in pain (Wald c2= 5.811, P< 0.05) and self-efficacy (Wald c2= 16.383, P< 0.05). However, there was no significant difference between the experimental and control groups in the group effect in dysfunction improvement (Wald c2= 2.289, P> 0.05).
CONCLUSIONS


The WeChat-based rehabilitation intervention can improve exercise compliance and self-efficacy, and help achieve greater pain relief compared to the routine intervention. However, the WeChat-based intervention did not offer better improvement in the self-dysfunction in the post-discharge LFS patients.",2021,"The WeChat-based rehabilitation intervention can improve exercise compliance and self-efficacy, and help achieve greater pain relief compared to the routine intervention.","['patients with LFS', 'Seventy-two eligible discharged LFS patients were enrolled from October 2018 to February 2019', 'patients with lumbar fusion surgery', 'LFS patients']","['WeChat-based individualized post-discharge rehabilitation program', 'WeChat-based rehabilitation intervention', 'Exercise training after lumbar fusion surgery (LFS', '10-week WeChat-based individualized rehabilitation program', 'routine follow-up guidance']","['self-efficacy', 'pain relief', 'self-dysfunction', 'pain', 'dysfunction improvement', 'exercise compliance', 'exercise compliance and self-efficacy', 'Exercise Compliance Questionnaire, Numerical Rating Scale, Oswestry Disability Index and Chinese version of the self-efficacy for exercise scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",72.0,0.00457221,"The WeChat-based rehabilitation intervention can improve exercise compliance and self-efficacy, and help achieve greater pain relief compared to the routine intervention.","[{'ForeName': 'Xiao-Yun', 'Initials': 'XY', 'LastName': 'Hu', 'Affiliation': 'Pharmacy School, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jia-Yu', 'Initials': 'JY', 'LastName': 'Li', 'Affiliation': 'Nursing School, Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Yu-Jie', 'Initials': 'YJ', 'LastName': 'Guo', 'Affiliation': 'Nursing School, Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'First Clinical Medical School, Nanjing Medical University, Nanjing, Jiangsu, China.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200280']
2865,34744048,Pedunculopontine and Cuneiform Nuclei Deep Brain Stimulation for Severe Gait and Balance Disorders in Parkinson's Disease: Interim Results from a Randomised Double-Blind Clinical Trial.,"BACKGROUND


Dopa-resistant freezing of gait (FOG) and falls represent the dominant motor disabilities in advanced Parkinson's disease (PD).
OBJECTIVE


We investigate the effects of deep brain stimulation (DBS) of the mesencephalic locomotor region (MLR), comprised of the pedunculopontine (PPN) and cuneiform (CuN) nuclei, for treating gait and balance disorders, in a randomized double-blind cross-over trial.
METHODS


Six PD patients with dopa-resistant FOG and/or falls were operated for MLR-DBS. Patients received three DBS conditions, PPN, CuN, or sham, in a randomized order for 2-months each, followed by an open-label phase. The primary outcome was the change in anteroposterior anticipatory-postural-adjustments (APAs) during gait initiation on a force platformResults:The anteroposterior APAs were not significantly different between the DBS conditions (median displacement [1st-3rd quartile] of 3.07 [3.12-4.62] cm with sham-DBS, 1.95 [2.29-3.85] cm with PPN-DBS and 2.78 [1.66-4.04] cm with CuN-DBS; p = 0.25). Step length and velocity were significantly higher with CuN-DBS vs. both sham-DBS and PPN-DBS. Conversely, step length and velocity were lower with PPN-DBS vs. sham-DBS, with greater double stance and gait initiation durations. One year after surgery, step length was significantly lower with PPN-DBS vs. inclusion. We did not find any significant change in clinical scales between DBS conditions or one year after surgery.
CONCLUSION


Two months of PPN-DBS or CuN-DBS does not effectively improve clinically dopa-resistant gait and balance disorders in PD patients.",2021,Two months of PPN-DBS or CuN-DBS does not effectively improve clinically dopa-resistant gait and balance disorders in PD patients.,"[""advanced Parkinson's disease (PD"", 'Six PD patients with dopa-resistant FOG and/or falls were operated for MLR-DBS', 'PD patients', ""Severe Gait and Balance Disorders in Parkinson's Disease""]","['PPN-DBS vs. sham-DBS', 'deep brain stimulation (DBS) of the mesencephalic locomotor region (MLR', 'pedunculopontine (PPN) and cuneiform (CuN) nuclei', 'Pedunculopontine and Cuneiform Nuclei Deep Brain Stimulation', 'PPN-DBS or CuN-DBS']","['change in anteroposterior anticipatory-postural-adjustments (APAs) during gait initiation on a force platformResults:The anteroposterior APAs', 'clinically dopa-resistant gait and balance disorders', 'step length and velocity', 'Step length and velocity', 'double stance and gait initiation durations', 'clinical scales']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013023', 'cui_str': 'Dihydroxyphenylalanine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0025462', 'cui_str': 'Midbrain structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0575090', 'cui_str': 'Balance disorder'}]","[{'cui': 'C1527386', 'cui_str': 'Peripheral line feeding'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025462', 'cui_str': 'Midbrain structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0013023', 'cui_str': 'Dihydroxyphenylalanine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0575090', 'cui_str': 'Balance disorder'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",6.0,0.450265,Two months of PPN-DBS or CuN-DBS does not effectively improve clinically dopa-resistant gait and balance disorders in PD patients.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bourilhon', 'Affiliation': 'Department of Neurophysiology, Rouen UniversityHospital and University of Rouen, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Olivier', 'Affiliation': 'Sorbonne Universités, UPMC Univ Paris 06, CNRS, INSERM, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France PANAM platform, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Sorbonne Universités, UPMC Univ Paris 06, CNRS, INSERM, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France PANAM platform, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Collomb-Clerc', 'Affiliation': 'Sorbonne Universités, UPMC Univ Paris 06, CNRS, INSERM, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France PANAM platform, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grabli', 'Affiliation': 'Sorbonne Universités, UPMC Univ Paris 06, CNRS, INSERM, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France PANAM platform, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France.'}, {'ForeName': 'Hayat', 'Initials': 'H', 'LastName': 'Belaid', 'Affiliation': 'Department of Neurosurgery, Pitié-Salpêtrière, Charles Foix University Hospital, Assistance Publique-Hôpitaux Paris, Paris, France.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Mullie', 'Affiliation': 'Sorbonne Universités, UPMC Univ Paris 06, CNRS, INSERM, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France PANAM platform, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'François', 'Affiliation': 'Sorbonne Universités, UPMC Univ Paris 06, CNRS, INSERM, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France PANAM platform, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Czernecki', 'Affiliation': 'Fédération des Maladies du Système Nerveux, Pitié-Salpêtrière, Charles Foix University Hospital, Assistance Publique-Hôpitaux de Paris Paris, Paris, France.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lau', 'Affiliation': 'Sorbonne Universités, UPMC Univ Paris 06, CNRS, INSERM, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France PANAM platform, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pérez-García', 'Affiliation': 'Sorbonne Universités, UPMC Univ Paris 06, CNRS, INSERM, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France PANAM platform, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bardinet', 'Affiliation': 'Sorbonne Universités, UPMC Univ Paris 06, CNRS, INSERM, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France PANAM platform, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fernandez-Vidal', 'Affiliation': 'Sorbonne Universités, UPMC Univ Paris 06, CNRS, INSERM, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France PANAM platform, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Karachi', 'Affiliation': 'Sorbonne Universités, UPMC Univ Paris 06, CNRS, INSERM, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France PANAM platform, Institut du Cerveau et de la Moelle Épinière (ICM), Paris, France.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Welter', 'Affiliation': 'Department of Neurophysiology, Rouen UniversityHospital and University of Rouen, France.'}]",Journal of Parkinson's disease,['10.3233/JPD-212793']
2866,34744407,Psychometric Properties of the Behavior Assessment System for Children Student Observation System (BASC-3 SOS) with Young Children in Special Education.,"Measuring classroom behavior among young children is important to guide assessment and intervention decisions, yet there is limited literature on appropriate direct observation tools for this purpose. This article describes the psychometric properties of the Behavior Assessment System for Children, Student Observation System (BASC-3 SOS) with 135 children ages 20 to 67 months ( M  = 35 months, 64% Latinx, 78% with an established developmental disability) and their teachers ( N  = 36) as part of a larger randomized control trial of a teacher training intervention. Inter-rater reliability on individual BASC-3 SOS behaviors ranged from poor to good. Correlations between BASC-3 SOS scores across time indicated low to moderate developmental test-retest reliability. Significant correlations between BASC-3 SOS scores and teacher ratings provided evidence for convergent, divergent, and predictive validity. Differences between BASC-3 SOS scores for children with versus without disabilities supported the tool's discriminant validity. There were no significant pre- to post-treatment changes in BASC-3 SOS scores. Overall, results provide mixed evidence for the psychometric properties of the BASC-3 SOS when used with young, diverse children with and without disabilities. Implications for clinical and research purposes are discussed.
Supplementary Information


The online version contains supplementary material available at 10.1007/s10864-021-09458-x.",2021,There were no significant pre- to post-treatment changes in BASC-3 SOS scores.,"['young children', 'Children Student Observation System (BASC-3 SOS) with Young Children in Special Education', 'Children, Student Observation System (BASC-3 SOS) with 135 children ages 20 to 67\xa0months ( M \u2009=\u200935\xa0months, 64% Latinx, 78% with an established developmental disability) and their teachers ( N \u2009=\u200936']",['teacher training intervention'],"['individual BASC-3 SOS behaviors', 'BASC-3 SOS scores and teacher ratings provided evidence for convergent, divergent, and predictive validity', 'BASC-3 SOS scores']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4225412', 'cui_str': 'Spondylo-ocular syndrome'}, {'cui': 'C0013649', 'cui_str': 'Special Education'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}]","[{'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4225412', 'cui_str': 'Spondylo-ocular syndrome'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",135.0,0.0314161,There were no significant pre- to post-treatment changes in BASC-3 SOS scores.,"[{'ForeName': 'Ellyn M', 'Initials': 'EM', 'LastName': 'Schmidt', 'Affiliation': 'Department of Pediatrics, Mailman Center for Child Development, University of Miami Miller School of Medicine, 1601 NW 12th Avenue, Miami, FL 33136 USA.'}, {'ForeName': 'W Andrew', 'Initials': 'WA', 'LastName': 'Rothenberg', 'Affiliation': 'Department of Pediatrics, Mailman Center for Child Development, University of Miami Miller School of Medicine, 1601 NW 12th Avenue, Miami, FL 33136 USA.'}, {'ForeName': 'Bridget C', 'Initials': 'BC', 'LastName': 'Davidson', 'Affiliation': 'Department of Pediatrics, Mailman Center for Child Development, University of Miami Miller School of Medicine, 1601 NW 12th Avenue, Miami, FL 33136 USA.'}, {'ForeName': 'Miya', 'Initials': 'M', 'LastName': 'Barnett', 'Affiliation': 'University of California, Santa Barbara, CA USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Jent', 'Affiliation': 'Department of Pediatrics, Mailman Center for Child Development, University of Miami Miller School of Medicine, 1601 NW 12th Avenue, Miami, FL 33136 USA.'}, {'ForeName': 'Heleny', 'Initials': 'H', 'LastName': 'Cadenas', 'Affiliation': 'Department of Pediatrics, Mailman Center for Child Development, University of Miami Miller School of Medicine, 1601 NW 12th Avenue, Miami, FL 33136 USA.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Fernandez', 'Affiliation': 'Department of Pediatrics, Mailman Center for Child Development, University of Miami Miller School of Medicine, 1601 NW 12th Avenue, Miami, FL 33136 USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, Mailman Center for Child Development, University of Miami Miller School of Medicine, 1601 NW 12th Avenue, Miami, FL 33136 USA.'}]",Journal of behavioral education,['10.1007/s10864-021-09458-x']
2867,34744864,Adaptation and Implementation of an Intervention Programme on Spanish Carers and Adolescent Patients With an Eating Disorder: Study Protocol of a Randomized Controlled Trial.,"Introduction:  One of the major problems with inpatient treatment of adolescent girls with an eating disorder (ED) is that the strategies learned during their hospital stay are not easily applied or maintained in their daily lives, and this has been related to high rates of relapse and readmission. The ECHOMANTRA programme was developed to optimize outcomes during and following inpatient or day-patient treatment. ECHOMANTRA is based on interventions for carers (Experienced Carers Helping Others, ECHO) and patients (Maudsley Model of Anorexia Nervosa Treatment for Adults, MANTRA) and is developed from the cognitive interpersonal model of anorexia (Schmidt and Treasure, 2006; Treasure and Schmidt, 2013). This study aims to describe the study protocol of a randomized controlled trial (RCT) for evaluating the efficacy of an adaptation of a novel intervention for patients and carers (ECHOMANTRA) to be implemented as an add-on to treatment-as-usual (TAU).  Method:  In a multi-center pilot RCT, 80 female adolescent patients with a DSM-5 diagnosis of an ED and their carers will be invited to participate in the study. They will then be randomized to receive either the ECHOMANTRA intervention as an add-on to TAU or TAU alone. A repeated measures design will be conducted across four time points. Primary outcomes will be patient psychological well-being and eating disorder symptoms, and secondary outcomes will include body mass index, obsessive-compulsive symptoms, perfectionism, motivation to change and psychosocial adjustment. For carers, outcome variables will include psychological well-being, expressed emotion, accommodation and enabling behaviors, burden, and care skills.  Discussion:  The results from this trial will establish the effectiveness of ECHOMANTRA and may reveal whether and to what extent this novel intervention can optimize outcomes during and following inpatient treatment. This study will also provide the adaptation of the ECHOMANTRA in the Spanish context for inpatient/day-care treatment.",2021,"ECHOMANTRA is based on interventions for carers (Experienced Carers Helping Others, ECHO) and patients (Maudsley Model of Anorexia Nervosa Treatment for Adults, MANTRA) and is developed from the cognitive interpersonal model of anorexia (Schmidt and Treasure, 2006; Treasure and Schmidt, 2013).","['Spanish Carers and Adolescent Patients With an Eating Disorder', '80 female adolescent patients with a DSM-5 diagnosis of an ED and their carers', 'adolescent girls with an eating disorder (ED', 'carers (Experienced Carers Helping Others, ECHO) and patients (Maudsley Model of Anorexia Nervosa Treatment for Adults, MANTRA', 'patients and carers (ECHOMANTRA']",['Intervention Programme'],"['psychological well-being, expressed emotion, accommodation and enabling behaviors, burden, and care skills', 'patient psychological well-being and eating disorder symptoms, and secondary outcomes will include body mass index, obsessive-compulsive symptoms, perfectionism, motivation to change and psychosocial adjustment']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]",80.0,0.0768012,"ECHOMANTRA is based on interventions for carers (Experienced Carers Helping Others, ECHO) and patients (Maudsley Model of Anorexia Nervosa Treatment for Adults, MANTRA) and is developed from the cognitive interpersonal model of anorexia (Schmidt and Treasure, 2006; Treasure and Schmidt, 2013).","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Quiles', 'Affiliation': 'Department of Behavioral Sciences and Health, University Miguel Hernández, Elche, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Quiles', 'Affiliation': 'Department of Behavioral Sciences and Health, University Miguel Hernández, Elche, Spain.'}, {'ForeName': 'Eva María', 'Initials': 'EM', 'LastName': 'León', 'Affiliation': 'Department of Behavioral Sciences and Health, University Miguel Hernández, Elche, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Roncero', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatments, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Ruiz', 'Affiliation': 'Department of Behavioral Sciences and Health, University Miguel Hernández, Elche, Spain.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'España', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatment, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Romero', 'Affiliation': 'Unit of Eating Disorders, University Hospital of San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Elvira', 'Affiliation': 'Unit of Eating Disorders, University Hospital of San Juan de Alicante, Alicante, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.697916']
2868,34744830,The Effect of Yijinjing on the Cognitive Function of Patients With Chronic Schizophrenia.,"Background:  Patients with chronic schizophrenia present cognitive impairment, which affects their social function and prevents them from reintegrating into society. Yijinjing is a traditional Chinese aerobic exercise that has a putative psychosomatic effect on improving cognitive function.  Methods:  From January to May 2021, 40 patients with chronic schizophrenia were recruited and randomly divided into a control group and a Yijinjing group. In the 12-week intervention, the patients in the control group received conventional treatment, whereas patients in the Yijinjing group performed Yijinjing exercise (40 min/session, twice a week) in addition to receiving conventional treatment. The Positive and Negative Syndrome Scale (PANSS), the Insight and Treatment Attitude Questionnaire (ITAQ), the Rosenberg Self-esteem Scale (SES), and the Mini Mental State Examination (MMSE) were used to measure clinical symptoms and cognitive function at 0, 6, and 12 weeks.  Results:  The demographic information was not significantly different between groups. At baseline, the scores of all the scales were not statistically different between groups. After 12 weeks of intervention, compared to those at baseline, the scores of the negative scale ( t  = 19.00,  p  < 0.0001), general psychopathology scale ( t  = 15.98,  p  < 0.0001), and total score ( t  = 15.47,  p  < 0.0001) of the PANSS and SES ( t  = 5.378,  p  < 0.0001) had significantly decreased, and the scores of the ITAQ ( t  = 7.984,  p  < 0.0001) and MMSE ( t  = 6.750,  p  < 0.0001) had significantly increased in Yijinjing group; the score of the MMSE increased in the control group as well ( t  = 2.491,  p  = 0.0222). Compared to the respective scores in the control group, the negative scale score ( t  = 2.953,  p  = 0.0054) significantly decreased, and the ITAQ ( t  = 3.043,  p  = 0.0042) and MMSE ( t  = 2.2.68,  p  = 0.0291) scores significantly increased in the Yijinjing group after 12 weeks of intervention.  Conclusion:  These results provide a preliminary indication that Yijinjing exercise had the potential to improve cognitive function and negative symptoms in patients with chronic schizophrenia. A larger-scale study to determine the trajectory of change in the longer term should be undertaken.",2021,"Compared to the respective scores in the control group, the negative scale score ( t  = 2.953,  p  = 0.0054) significantly decreased, and the ITAQ ( t  = 3.043,  p  = 0.0042) and MMSE ( t  = 2.2.68,  p  = 0.0291) scores significantly increased in the Yijinjing group after 12 weeks of intervention.  ","['patients with chronic schizophrenia', 'Patients with chronic schizophrenia present cognitive impairment', '40 patients with chronic schizophrenia', 'Patients With Chronic Schizophrenia']","['conventional treatment', 'Chinese aerobic exercise', 'Yijinjing exercise (40 min/session, twice a week) in addition to receiving conventional treatment']","['Positive and Negative Syndrome Scale (PANSS), the Insight and Treatment Attitude Questionnaire (ITAQ), the Rosenberg Self-esteem Scale (SES), and the Mini Mental State Examination (MMSE', 'score of the MMSE', 'scores of the negative scale', 'general psychopathology scale', 'total score', 'ITAQ', 'Cognitive Function', 'cognitive function and negative symptoms', 'MMSE', 'negative scale score', 'scores of the ITAQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",40.0,0.0136576,"Compared to the respective scores in the control group, the negative scale score ( t  = 2.953,  p  = 0.0054) significantly decreased, and the ITAQ ( t  = 3.043,  p  = 0.0042) and MMSE ( t  = 2.2.68,  p  = 0.0291) scores significantly increased in the Yijinjing group after 12 weeks of intervention.  ","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Department of Psychiatry, Shanghai No.1 Mental Health Center of Civil Administration, Shanghai, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Shanghai Institute of Traditional Chinese Medicine for Mental Health, Shanghai Clinical Research Center for Mental Health, Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Si-Jing', 'Initials': 'SJ', 'LastName': 'Tu', 'Affiliation': 'School of Public Health, Hangzhou Normal University, Hangzhou, China.'}, {'ForeName': 'Ru-Ping', 'Initials': 'RP', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, Shanghai No.1 Mental Health Center of Civil Administration, Shanghai, China.'}, {'ForeName': 'Lin-Na', 'Initials': 'LN', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry, Shanghai No.1 Mental Health Center of Civil Administration, Shanghai, China.'}, {'ForeName': 'Hui-Jun', 'Initials': 'HJ', 'LastName': 'Qiao', 'Affiliation': 'Department of Psychiatry, Shanghai No.1 Mental Health Center of Civil Administration, Shanghai, China.'}, {'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Shanghai No.1 Mental Health Center of Civil Administration, Shanghai, China.'}, {'ForeName': 'Ning-Ning', 'Initials': 'NN', 'LastName': 'Li', 'Affiliation': 'Shanghai Institute of Traditional Chinese Medicine for Mental Health, Shanghai Clinical Research Center for Mental Health, Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Traditional Chinese Medicine for Mental Health, Shanghai Clinical Research Center for Mental Health, Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2021.739364']
2869,34744825,"Study Protocol for ""Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study"".","Background:  Anorexia nervosa (AN) is a serious and life-threatening psychiatric condition. With a paucity of approved treatments, there is a desperate need for novel treatment avenues to be explored. Here, we present (1) an overview of the ways through which Public Patient Involvement (PPI) has informed a trial of psilocybin-assisted therapy for AN and (2) a protocol for a pilot study of psilocybin-assisted therapy in AN currently underway at Imperial College London. The study aims to assess the feasibility, brain mechanisms and preliminary outcomes of treating anorexia nervosa with psilocybin.  Methods:  (1) PPI: Across two online focus groups, eleven individuals with lived experience of AN were presented with an overview of the protocol. Their feedback not only identified solutions to possible barriers for future participants, but also helped the research team to better understand the concept of "" recovery""  from the perspective of those with lived experience. (2) Protocol: Twenty female participants [21-65 years old, body mass index (BMI) 15 kg/m 2  or above] will receive three oral doses of psilocybin (up to 25 mg) over a 6-week period delivered in a therapeutic environment and enveloped by psychological preparation and integration. We will work with participant support networks (care teams and an identified support person) throughout and there will be an extended remote follow-up period of 12 months. Our two-fold primary outcomes are (1) psychopathology (Eating Disorder Examination) across the 6-month follow-up and (2) readiness and motivation to engage in recovery (Readiness and Motivation Questionnaire) across the 6-week trial period. Neurophysiological outcome measures will be: (1) functional magnetic resonance imaging (fMRI) brain changes from baseline to 6-week endpoint and (2) post-acute changes in electroencephalography (EEG) activity, including an electrophysiological marker of neuronal plasticity.  Discussion:  The results of this pilot study will not only shed light on the acceptability, brain mechanisms, and impression of the potential efficacy of psilocybin as an adjunct treatment for AN but will be essential in shaping a subsequent Randomised Control Trial (RCT) that would test this treatment against a suitable control condition.  Clinical Trial Registration:  identifier: NCT04505189.",2021,"Their feedback not only identified solutions to possible barriers for future participants, but also helped the research team to better understand the concept of "" recovery""  from the perspective of those with lived experience.","['anorexia nervosa with psilocybin', 'Anorexia Nervosa', 'eleven individuals with lived experience of AN were presented with an overview of the protocol', '2) Protocol: Twenty female participants [21-65 years old, body mass index (BMI) 15 kg/m 2  or above']","['Psilocybin', 'psilocybin', 'PPI', 'psilocybin-assisted therapy']","['psychopathology (Eating Disorder Examination) across the 6-month follow-up and (2) readiness and motivation to engage in recovery (Readiness and Motivation Questionnaire', 'Neurophysiological outcome measures will be: (1) functional magnetic resonance imaging (fMRI) brain changes from baseline to 6-week endpoint and (2) post-acute changes in electroencephalography (EEG) activity, including an electrophysiological marker of neuronal plasticity']","[{'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}]","[{'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C2732388', 'cui_str': 'Eating disorder examination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}]",,0.0881525,"Their feedback not only identified solutions to possible barriers for future participants, but also helped the research team to better understand the concept of "" recovery""  from the perspective of those with lived experience.","[{'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Spriggs', 'Affiliation': 'Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Douglass', 'Affiliation': 'Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Park', 'Affiliation': 'OxBREaD Research Group, Department of Psychiatry, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Read', 'Affiliation': 'Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Danby', 'Affiliation': 'Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Frederico J C', 'Initials': 'FJC', 'LastName': 'de Magalhães', 'Affiliation': 'Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Kirsty L', 'Initials': 'KL', 'LastName': 'Alderton', 'Affiliation': 'Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Tim M', 'Initials': 'TM', 'LastName': 'Williams', 'Affiliation': 'Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Blemings', 'Affiliation': 'Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Lafrance', 'Affiliation': 'School of Rural and Northern Health, Laurentian University, Sudbury, ON, Canada.'}, {'ForeName': 'Dasha E', 'Initials': 'DE', 'LastName': 'Nicholls', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erritzoe', 'Affiliation': 'Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Nutt', 'Affiliation': 'Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Carhart-Harris', 'Affiliation': 'Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2021.735523']
2870,34744722,Combination of Dexmedetomidine and Tramadol in Patient-Controlled Intravenous Analgesia Strengthens Sedative Effect in Pregnancy-Induced Hypertension.,"Objective:  The aim of the present study is to explore the combination of dexmedetomidine (DXM) and tramadol (TMD) on sedative effect in patients with pregnancy-induced hypertension (PIH).  Methods:  A total of 356 patients with pregnancy-induced hypertension (PIH) were randomly divided into three groups: DXM, TMD and DXM + TMD groups. These patients were treated with different doses of DXM, TMD or combination of DXM and TMD by a patient-controlled intravenous injection device. The scores of static pain and dynamic pain, sedation degree, and adverse reaction were recorded. The plasma levels of inflammatory mediators IL-10 and C-reactive protein (CRP), and the serum level of p-p38-MAPK were evaluated.  Results:  It was found that administration with DXM 1.0 µg/kg/h + TMD 700 mg and DXM 2.0 µg/kg/h + TMD 600 mg result in stronger sedative effect than single administration with DXM or TMD. The mean arterial pressure (MAP) and heart rate (HR) of patients with PIH were decreased with the combinational treatment of DXM and TMD. Interestingly, the PIH patients injected with DXM 1.0 µg/kg/h + TMD 700 mg and DXM 2.0 µg/kg/h + TMD 600 mg showed stronger sedative effect. In addition, the plasma level of level of IL-10 was increased and CRP decreased. The serum level of p-p38/MAPK was decreased.  Conclusion:  Taken together, our study indicates that combination of DXM and TMD effectively lowers blood pressure and reduces inflammation through increasing the level of IL-10, reducing CRP and inhibiting p-p38/MAPK in patients with PIH. This study suggests that the combination of DXM and TMD could be an anesthetic choice in the management of PIH.",2021,"The plasma levels of inflammatory mediators IL-10 and C-reactive protein (CRP), and the serum level of p-p38-MAPK were evaluated.  ","['Pregnancy-Induced Hypertension', '356 patients with pregnancy-induced hypertension (PIH', 'patients with PIH', 'patients with pregnancy-induced hypertension (PIH']","['Dexmedetomidine and Tramadol', 'DXM or TMD', 'DXM, TMD or combination of DXM and TMD', 'dexmedetomidine (DXM) and tramadol (TMD', 'DXM and TMD', 'DXM, TMD and DXM + TMD', 'TMD', 'DXM']","['mean arterial pressure (MAP) and heart rate (HR) of patients with PIH', 'sedative effect', 'plasma levels of inflammatory mediators IL-10 and C-reactive protein (CRP), and the serum level of p-p38-MAPK', 'plasma level of level of IL-10', 'blood pressure', 'serum level of p-p38/MAPK', 'scores of static pain and dynamic pain, sedation degree, and adverse reaction']","[{'cui': 'C0852036', 'cui_str': 'Pregnancy-induced hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033373', 'cui_str': 'Prolactin inhibiting factor'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033373', 'cui_str': 'Prolactin inhibiting factor'}, {'cui': 'C3179159', 'cui_str': 'Sedative Effects'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0257535', 'cui_str': 'CSAID-Binding Protein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",356.0,0.0165489,"The plasma levels of inflammatory mediators IL-10 and C-reactive protein (CRP), and the serum level of p-p38-MAPK were evaluated.  ","[{'ForeName': 'Shu-Yao', 'Initials': 'SY', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Guangzhou Red Cross Hospital Jinan University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Affiliated Hospital of Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmacy, Guangzhou Red Cross Hospital Jinan University, Guangzhou, China.'}, {'ForeName': 'Qiuzhen', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Guangzhou Red Cross Hospital Jinan University, Guangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Guangzhou Red Cross Hospital Jinan University, Guangzhou, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, Guangzhou Red Cross Hospital Jinan University, Guangzhou, China.'}, {'ForeName': 'Xia-Lan', 'Initials': 'XL', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Affiliated Hospital of Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Chengkuan', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Guangzhou Red Cross Hospital Jinan University, Guangzhou, China.'}, {'ForeName': 'Meini', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacology, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Dong-Hua', 'Initials': 'DH', 'LastName': 'Yang', 'Affiliation': ""Department of Pharmaceutical Sciences, St. John's University College of Pharmacy and Health Sciences, Queens, NY, United States.""}]",Frontiers in pharmacology,['10.3389/fphar.2021.739749']
2871,34744714,"Prophylactic Phenylephrine Increases the Dose Requirement of Oxytocin to Treat Uterine Atony During Cesarean Delivery: A Double-Blinded, Single-Center, Randomized and Placebo-Controlled Trial.","Purpose:  Studies involving mouse models and human uterine smooth muscle cells have shown that phenylephrine inhibits uterine contractions in non-pregnant mice and human  in vitro  cell  via  cyclic adenosine monophosphate (cAMP) signaling. However, there has been no limited exploration to date of the effect of phenylephrine on uterine contractions in clinical practice. This study aimed to compare the dose requirement of oxytocin with or without the infusion of prophylactic phenylephrine to prevent post spinal hypotension during cesarean delivery under combined spinal and epidural anesthesia.  Methods:  This was a double-blinded, single-center, randomized, control study. One hundred and sixty pregnant patients provided informed consent and were randomly allocated to the phenylephrine (phenylephrine infusion) and control (saline infusion) groups. Patients randomized to the phenylephrine group received an intravenous prophylactic phenylephrine infusion at a fixed rate of 0.5 μg/kg/min. The control group received a saline placebo at the same rate and used the same apparatus for delivery. After neonatal delivery and clamping of the umbilical cord, patients received a standard institutional oxytocin protocol. The primary outcome measure was the total dose of oxytocin administered during CD. Secondary outcomes including the proportion (%) of patients requiring a secondary uterotonic agent and estimated blood loss (EBL) in the first 24 h after surgery.  Results:  The median oxytocin dose administered was significantly higher in the phenylephrine group than in the control group [6.9 ± 2.5 international standardized units (IU)  vs.  5.4 ± 2.4 IU,  p  = 0.0004]. The number of patients that required a secondary uterotonic agent was significantly higher in the phenylephrine group than in the control group (24.2%  vs.  9.1%;  p  = 0.034). The EBL in the first 24-h postoperatively was similar between the two groups (467 ± 47 ml  vs.  392 ± 38 ml;  p  = 0.22).  Conclusions:  Prophylactic infusion of phenylephrine used to prevent post-spinal hypotension during CD was associated with a higher dose of oxytocin. This has important clinical implications, as the suboptimal use of oxytocin is associated with an increased risk of postpartum hemorrhage and increased maternal morbidity and mortality. Further studies are now needed to confirm these findings.",2021,The number of patients that required a secondary uterotonic agent was significantly higher in the phenylephrine group than in the control group (24.2%  vs.  9.1%;  p  = 0.034).,['One hundred and sixty pregnant patients'],"['phenylephrine', 'Placebo', 'saline placebo', 'prophylactic phenylephrine', 'oxytocin', 'standard institutional oxytocin protocol', 'phenylephrine (phenylephrine infusion) and control (saline infusion', 'Oxytocin', 'intravenous prophylactic phenylephrine infusion', 'Prophylactic Phenylephrine']","['total dose of oxytocin administered during CD', 'maternal morbidity and mortality', 'number of patients that required a secondary uterotonic agent', 'proportion (%) of patients requiring a secondary uterotonic agent and estimated blood loss (EBL', 'median oxytocin dose administered', 'EBL']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3653843', 'cui_str': 'UTEROTONICS'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",160.0,0.688877,The number of patients that required a secondary uterotonic agent was significantly higher in the phenylephrine group than in the control group (24.2%  vs.  9.1%;  p  = 0.034).,"[{'ForeName': 'Yao-Hua', 'Initials': 'YH', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesia, Hangzhou City Linping District Maternal and Child Care Hospital, Hangzhou, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders (Ministry of Education), Bio-X Institutes, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Li-Dan', 'Initials': 'LD', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesia, Hangzhou City Linping District Maternal and Child Care Hospital, Hangzhou, China.'}, {'ForeName': 'Yu-Jia', 'Initials': 'YJ', 'LastName': 'Qian', 'Affiliation': 'Department of Anesthesia, Hangzhou City Linping District Maternal and Child Care Hospital, Hangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xing', 'Affiliation': 'Department of Anesthesia, Hangzhou City Linping District Maternal and Child Care Hospital, Hangzhou, China.'}, {'ForeName': 'Ya-Li', 'Initials': 'YL', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesia, Hangzhou City Linping District Maternal and Child Care Hospital, Hangzhou, China.'}, {'ForeName': 'Su-Feng', 'Initials': 'SF', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesia, Hangzhou City Linping District Maternal and Child Care Hospital, Hangzhou, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2021.720906']
2872,34744698,Impact of Transcranial Direct Current Stimulation and Cognitive Training on Frontal Lobe Neurotransmitter Concentrations.,"Objective:  This study examines the impact of transcranial direct current stimulation (tDCS) combined with cognitive training on neurotransmitter concentrations in the prefrontal cortex.  Materials and Methods:  Twenty-three older adults were randomized to either active-tDCS or sham-tDCS in combination with cognitive training for 2 weeks. Active-tDCS was delivered over F3 (cathode) and F4 (anode) electrode placements for 20 min at 2 mA intensity. For each training session, 40-min of computerized cognitive training were applied with active or sham stimulation delivered during the first 20-min. Glutamine/glutamate (Glx) and gamma-aminobutyric acid (GABA) concentrations  via  proton magnetic resonance spectroscopy were evaluated at baseline and at the end of 2-week intervention.  Results:  Glx concentrations increased from pre- to post-intervention ( p  = 0.010) in the active versus sham group after controlling for age, number of intervention days, MoCA scores, and baseline Glx concentration. No difference in GABA concentration was detected between active and sham groups ( p  = 0.650) after 2-week intervention.  Conclusion:  Results provide preliminary evidence suggesting that combining cognitive training and tDCS over the prefrontal cortex elicits sustained increase in excitatory neurotransmitter concentrations. Findings support the combination of tDCS and cognitive training as a potential method for altering neurotransmitter concentrations in the frontal cortices, which may have implications for neuroplasticity in the aging brain.",2021,"Glx concentrations increased from pre- to post-intervention ( p  = 0.010) in the active versus sham group after controlling for age, number of intervention days, MoCA scores, and baseline Glx concentration.",['Materials and Methods:  Twenty-three older adults'],"['active-tDCS or sham-tDCS in combination with cognitive training', 'Active-tDCS was delivered over F3 (cathode) and F4 (anode) electrode placements', 'transcranial direct current stimulation (tDCS) combined with cognitive training', 'Transcranial Direct Current Stimulation and Cognitive Training', 'tDCS and cognitive training']","['excitatory neurotransmitter concentrations', 'Glx concentrations', 'Glutamine/glutamate (Glx) and gamma-aminobutyric acid (GABA) concentrations', 'GABA concentration']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}]",23.0,0.0427971,"Glx concentrations increased from pre- to post-intervention ( p  = 0.010) in the active versus sham group after controlling for age, number of intervention days, MoCA scores, and baseline Glx concentration.","[{'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Alvarez-Alvarado', 'Affiliation': 'Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Emanuel M', 'Initials': 'EM', 'LastName': 'Boutzoukas', 'Affiliation': 'Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Jessica N', 'Initials': 'JN', 'LastName': 'Kraft', 'Affiliation': 'Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': ""O'Shea"", 'Affiliation': 'Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Aprinda', 'Initials': 'A', 'LastName': 'Indahlastari', 'Affiliation': 'Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Albizu', 'Affiliation': 'Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'Nissim', 'Affiliation': 'Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Nicole D', 'Initials': 'ND', 'LastName': 'Evangelista', 'Affiliation': 'Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Porges', 'Affiliation': 'Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Woods', 'Affiliation': 'Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2021.761348']
2873,34744686,"Multimodal Exercise Effects in Older Adults Depend on Sleep, Movement Biography, and Habitual Physical Activity: A Randomized Controlled Trial.","Background:  The promotion of healthy aging is one of the major challenges for healthcare systems in current times. The present study investigates the effects of a standardized physical activity intervention for older adults on cognitive capacity, self-reported health, fear of falls, balance, leg strength and gait under consideration of movement biography, sleep duration, and current activity behavior.  Methods:  This single-blinded, randomized controlled trial included 49 community-dwelling older adults (36 women; 82.9 ± 4.5 years of age (Mean [M] ± SD); intervention group = 25; control group = 24). Movement biography, sleep duration, cognitive capacity, self-reported health status, and fear of falls were assessed by means of questionnaires. Leg strength, gait, and current activity levels were captured using a pressure plate, accelerometers, and conducting the functional-reach and chair-rising-test. The multicomponent intervention took place twice a week for 45 min and lasted 16 weeks. Sub-cohorts of different sleep duration were formed to distinguish between intervention effects and benefits of healthy sleep durations. Change scores were evaluated in univariate analyses of covariances (ANCOVAs) between groups and sub-cohorts of different sleep duration in both groups. Changes in cognitive capacity, self-reported health, fear of falls, balance, leg strength, and gait were investigated using the respective baseline values, movement biography, and current activity levels as covariates. Analysis was by intention-to-treat (ITT).  Results:  We found sub-cohort differences in cognitive capacity change scores [ F   (3,48)  = 5.498,  p  = 0.003, η p   2  = 0.287]. Effects on fear of falls [ F   (1,48)  = 12.961,  p  = 0.001, η p   2  = 0.240] and balance change scores  F   (1,48)  = 4.521,  p  = 0.040, η p   2  = (0.099) were modified by the level of current activity. Effects on gait cadence were modified by the movement biography [ F   (1,48)  = 4.545;  p  = 0.039, η p   2  = 0.100].  Conclusions:  Unlike for functional outcomes, our multicomponent intervention in combination with adequate sleep duration appears to provide combinable beneficial effects for cognitive capacity in older adults. Trainability of gait, fear of falls, and flexibility seems to be affected by movement biography and current physical activity levels.  Trial registration:  This study was registered at the DRKS (German Clinical Trials Register) on November 11, 2020 with the corresponding trial number: DRKS00020472.",2021,"Effects on gait cadence were modified by the movement biography [ F   (1,48)  = 4.545;  p  = 0.039, η p   2  = 0.100].  ","['older adults', 'Older Adults', '49 community-dwelling older adults (36 women; 82.9 ± 4.5 years of age (Mean [M] ± SD); intervention group = 25; control group = 24']",['standardized physical activity intervention'],"['Movement biography, sleep duration, cognitive capacity, self-reported health status, and fear of falls', 'cognitive capacity, self-reported health, fear of falls, balance, leg strength and gait under consideration of movement biography, sleep duration, and current activity behavior', 'fear of falls [ F', 'Sleep, Movement Biography, and Habitual Physical Activity', 'cognitive capacity, self-reported health, fear of falls, balance, leg strength, and gait', 'gait cadence', 'cognitive capacity change scores', 'Trainability of gait, fear of falls, and flexibility', 'Leg strength, gait, and current activity levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0005504', 'cui_str': 'Biography'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1272681', 'cui_str': 'Under consideration'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",49.0,0.115465,"Effects on gait cadence were modified by the movement biography [ F   (1,48)  = 4.545;  p  = 0.039, η p   2  = 0.100].  ","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Vogel', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Institute of Sports Sciences, Johann Wolfgang Goethe-University, Frankfurt, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Niederer', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Institute of Sports Sciences, Johann Wolfgang Goethe-University, Frankfurt, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Institute of Sports Sciences, Johann Wolfgang Goethe-University, Frankfurt, Germany.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2021.722799']
2874,34744685,Working Memory Training and Cortical Arousal in Healthy Older Adults: A Resting-State EEG Pilot Study.,"The current pilot study aimed to test the gains of working memory (WM) training, both at the short- and long-term, at a behavioral level, and by examining the electrophysiological changes induced by training in resting-state EEG activity among older adults. The study group included 24 older adults (from 64 to 75 years old) who were randomly assigned to a training group (TG) or an active control group (ACG) in a double-blind, repeated-measures experimental design in which open eyes, resting-state EEG recording, followed by a WM task, i.e., the Categorization Working Memory Span (CWMS) task, were collected before and after training, as well as at a 6-month follow-up session. At the behavioral level, medium to large Cohen's  d  effect sizes was found for the TG in immediate and long-term gains in the WM criterion task, as compared with small gains for the ACG. Regarding intrusion errors committed in the CWMS, an index of inhibitory control representing a transfer effect, results showed that medium to large effect sizes for immediate and long-term gains emerged for the TG, as compared to small effect sizes for the ACG. Spontaneous high-beta/alpha ratio analyses in four regions of interest (ROIs) revealed no pre-training group differences. Significantly greater TG anterior rates, particularly in the left ROI, were found after training, with frontal oscillatory responses being correlated with better post-training CWMS performance in only the TG. The follow-up analysis showed similar results, with greater anterior left high-beta/alpha rates among TG participants. Follow-up frontal high-beta/alpha rates in the right ROI were correlated with lower CWMS follow-up intrusion errors in only the TG. The present findings are further evidence of the efficacy of WM training in enhancing the cognitive functioning of older adults and their frontal oscillatory activity. Overall, these results suggested that WM training also can be a promising approach toward fostering the so-called functional cortical plasticity in aging.",2021,"Significantly greater TG anterior rates, particularly in the left ROI, were found after training, with frontal oscillatory responses being correlated with better post-training CWMS performance in only the TG.","['older adults', 'Healthy Older Adults', '24 older adults (from 64 to 75 years old']","['Working Memory Training', 'working memory (WM) training', 'WM training', 'training group (TG) or an active control group (ACG) in a double-blind, repeated-measures experimental design in which open eyes, resting-state EEG recording, followed by a WM task']","['anterior left high-beta/alpha rates', 'Categorization Working Memory Span (CWMS) task', 'TG anterior rates']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0441998', 'cui_str': 'Left anterior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",24.0,0.00837311,"Significantly greater TG anterior rates, particularly in the left ROI, were found after training, with frontal oscillatory responses being correlated with better post-training CWMS performance in only the TG.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Spironelli', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Borella', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2021.718965']
2875,34745008,Computed Tomography-Based Radiomics Model to Predict Central Cervical Lymph Node Metastases in Papillary Thyroid Carcinoma: A Multicenter Study.,"Objectives


This study aimed to develop a computed tomography (CT)-based radiomics model to predict central lymph node metastases (CLNM) preoperatively in patients with papillary thyroid carcinoma (PTC).
Methods


In this retrospective study, 678 patients with PTC were enrolled from Yantai Yuhuangding Hot3spital (n=605) and the Affiliated Hospital of Binzhou Medical University (n=73) within August 2010 to December 2020. The patients were randomly divided into a training set (n=423), an internal test set (n=182), and an external test set (n=73). Radiomics features of each patient were extracted from preoperative plain scan and contrast-enhanced CT images (arterial and venous phases). One-way analysis of variance (ANOVA) and least absolute shrinkage and selection operator algorithm were used for feature selection. The K-nearest neighbor, logistics regression, decision tree, linear-support vector machine (linear-SVM), Gaussian-SVM, and polynomial-SVM algorithms were used to establish radiomics models for CLNM prediction. The clinical risk factors were selected by ANOVA and multivariate logistic regression. Incorporated with clinical risk factors, a combined radiomics model was established for the preoperative prediction of CLNM in patients with PTCs. The performance of the combined radiomics model was evaluated using the receiver operating characteristic (ROC) and calibration curves in the training and test sets. The clinical usefulness was evaluated through decision curve analysis (DCA).
Results


A total of 4227 radiomic features were extracted from the CT images of each patient, and 14 non-zero coefficient features associated with CLNM were selected. Four clinical variables (sex, age, tumor diameter, and CT-reported lymph node status) were significantly associated with CLNM. Linear-SVM led to the best prediction model, which incorporated radiomic features and clinical risk factors. Areas under the ROC curves of 0.747 (95% confidence interval [CI] 0.706-0.782), 0.710 (95% CI 0.634-0.786), and 0.764 (95% CI 0.654-0.875) were obtained in the training, internal, and external test sets, respectively. The linear-SVM algorithm also showed better sensitivity (0.702 [95% CI 0.600-0.790]  vs.  0.477 [95% CI 0.409-0.545]) and accuracy (0.670 [95% CI 0.600-0.738]  vs.  0.642 [95% CI 0.569-0.712]) than an experienced radiologist in the internal test set in the combined radiomics model. The calibration plot reflected a favorable agreement between the actual and estimated probabilities of CLNM. The DCA indicated the clinical usefulness of the combined radiomics model.
Conclusion


The combined radiomics model is a non-invasive preoperative tool that incorporates radiomic features and clinical risk factors to predict CLNM in patients with PTC.",2021,The linear-SVM algorithm also showed better sensitivity (0.702 [95% CI 0.600-0.790]  vs.  0.477 [95% CI 0.409-0.545]) and accuracy (0.670 [95% CI 0.600-0.738]  vs.  0.642 [95% CI 0.569-0.712]) than an experienced radiologist in the internal test set in the combined radiomics model.,"['patients with PTC', '678 patients with PTC were enrolled from Yantai Yuhuangding Hot3spital (n=605) and the Affiliated Hospital of Binzhou Medical University (n=73) within August 2010 to December 2020', 'patients with PTCs', 'patients with papillary thyroid carcinoma (PTC', 'Papillary Thyroid Carcinoma']","['Computed Tomography-Based Radiomics Model', 'computed tomography (CT)-based radiomics model']","['sensitivity', 'accuracy', 'receiver operating characteristic (ROC) and calibration curves']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",678.0,0.0717574,The linear-SVM algorithm also showed better sensitivity (0.702 [95% CI 0.600-0.790]  vs.  0.477 [95% CI 0.409-0.545]) and accuracy (0.670 [95% CI 0.600-0.738]  vs.  0.642 [95% CI 0.569-0.712]) than an experienced radiologist in the internal test set in the combined radiomics model.,"[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Second Clinical Medicine College, Binzhou Medical University, Yantai, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Mao', 'Affiliation': 'Department of Radiology, Yantai Yuhuangding Hospital, Yantai, China.'}, {'ForeName': 'Guibin', 'Initials': 'G', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid Surgery, Yantai Yuhuangding Hospital, Yantai, China.'}, {'ForeName': 'Haicheng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Big Data and Artificial Intelligence Laboratory, Yantai Yuhuangding Hospital, Yantai, China.'}, {'ForeName': 'Yakui', 'Initials': 'Y', 'LastName': 'Mou', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Mi', 'Affiliation': 'Precision Medicine Research Center, Binzhou Medical University, Yantai, China.'}, {'ForeName': 'Xicheng', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2021.741698']
2876,34744972,Evolution of Blood-Brain Barrier Permeability in Subacute Ischemic Stroke and Associations With Serum Biomarkers and Functional Outcome.,"Background and Purpose:  In the setting of acute ischemic stroke, increased blood-brain barrier permeability (BBBP) as a sign of injury is believed to be associated with increased risk of poor outcome. Pre-clinical studies show that selected serum biomarkers including C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNFα), matrix metallopeptidases (MMP), and vascular endothelial growth factors (VEGFs) may play a role in BBBP post-stroke. In the subacute phase of stroke, increased BBBP may also be caused by regenerative mechanisms such as vascular remodeling and therefore may improve functional recovery. Our aim was to investigate the evolution of BBBP in ischemic stroke using contrast-enhanced (CE) magnetic resonance imaging (MRI) and to analyze potential associations with blood-derived biomarkers as well as functional recovery in subacute ischemic stroke patients.  Methods:  This is an exploratory analysis of subacute ischemic stroke patients enrolled in the  BAPTISe  study nested within the randomized controlled  PHYS-STROKE  trial (interventions: 4 weeks of aerobic fitness training vs. relaxation). Patients with at least one CE-MRI before (v1) or after (v2) the intervention were eligible for this analysis. The prevalence of increased BBBP was visually assessed on T1-weighted MR-images based on extent of contrast-agent enhancement within the ischemic lesion. The intensity of increased BBBP was assessed semi-quantitatively by normalizing the mean voxel intensity within the region of interest (ROI) to the contralateral hemisphere (""normalized CE-ROI""). Selected serum biomarkers (high-sensitive CRP, IL-6, TNF-α, MMP-9, and VEGF) at v1 (before intervention) were analyzed as continuous and dichotomized variables defined by laboratory cut-off levels. Functional outcome was assessed at 6 months after stroke using the modified Rankin Scale (mRS).  Results:  Ninety-three patients with a median baseline NIHSS of 9 [IQR 6-12] were included into the analysis. The median time to v1 MRI was 30 days [IQR 18-37], and the median lesion volume on v1 MRI was 4 ml [IQR 1.2-23.4]. Seventy patients (80%) had increased BBBP visible on v1 MRI. After the trial intervention, increased BBBP was still detectable in 52 patients (74%) on v2 MRI. The median time to v2 MRI was 56 days [IQR 46-67]. The presence of increased BBBP on v1 MRI was associated with larger lesion volumes and more severe strokes. Aerobic fitness training did not influence the increase of BBBP evaluated at v2. In linear mixed models, the time from stroke onset to MRI was inversely associated with normalized CE-ROI (coefficient -0.002, Standard Error 0.007,  p  < 0.01). Selected serum biomarkers were not associated with the presence or evolution of increased BBBP. Multivariable regression analysis did not identify the occurrence or evolution of increased BBBP as an independent predictor of favorable functional outcome post-stroke.  Conclusion:  In patients with moderate-to-severe subacute stroke, three out of four patients demonstrated increased BBB permeability, which decreased over time. The presence of increased BBBP was associated with larger lesion volumes and more severe strokes. We could not detect an association between selected serum biomarkers of inflammation and an increased BBBP in this cohort. No clear association with favorable functional outcome was observed.  Trial registration:  NCT01954797.",2021,"Selected serum biomarkers (high-sensitive CRP, IL-6, TNF-α, MMP-9, and VEGF) at v1 (before intervention) were analyzed as continuous and dichotomized variables defined by laboratory cut-off levels.","['Subacute Ischemic Stroke and Associations', 'Patients with at least one CE-MRI before (v1) or after (v2) the intervention were eligible for this analysis', 'Ninety-three patients with a median baseline NIHSS of 9 [IQR 6-12', 'patients with moderate-to-severe subacute stroke', 'subacute ischemic stroke patients']","['aerobic fitness training vs. relaxation', 'contrast-enhanced (CE) magnetic resonance imaging (MRI', 'Aerobic fitness training']","['BBB permeability', 'modified Rankin Scale (mRS', 'median time to v1 MRI', 'median lesion volume', 'normalized CE-ROI', 'BBBP', 'blood-brain barrier permeability (BBBP', 'severe strokes', 'C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNFα), matrix metallopeptidases (MMP), and vascular endothelial growth factors (VEGFs', 'Functional outcome', 'BBBP visible', 'median time to v2 MRI', 'intensity of increased BBBP', 'Selected serum biomarkers (high-sensitive CRP, IL-6, TNF-α, MMP-9, and VEGF']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0005854', 'cui_str': 'Brain-Blood Barrier'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C1256770', 'cui_str': 'VEGFs'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}]",93.0,0.0323484,"Selected serum biomarkers (high-sensitive CRP, IL-6, TNF-α, MMP-9, and VEGF) at v1 (before intervention) were analyzed as continuous and dichotomized variables defined by laboratory cut-off levels.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Müller', 'Affiliation': 'Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kufner', 'Affiliation': 'Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': ""Dell'Orco"", 'Affiliation': 'Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Rackoll', 'Affiliation': 'Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Mekle', 'Affiliation': 'Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Sophie K', 'Initials': 'SK', 'LastName': 'Piper', 'Affiliation': 'Berlin Institute of Health (BIH), Berlin, Germany.'}, {'ForeName': 'Jochen B', 'Initials': 'JB', 'LastName': 'Fiebach', 'Affiliation': 'Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Kersten', 'Initials': 'K', 'LastName': 'Villringer', 'Affiliation': 'Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Flöel', 'Affiliation': 'Department of Neurology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ebinger', 'Affiliation': 'Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Alexander H', 'Initials': 'AH', 'LastName': 'Nave', 'Affiliation': 'Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.'}]",Frontiers in neurology,['10.3389/fneur.2021.730923']
2877,34763663,'Asking for help': a qualitative interview study exploring the experiences of interpersonal counselling (IPC) compared to low-intensity cognitive behavioural therapy (CBT) for women with depression during pregnancy.,"BACKGROUND


Treating depression early in pregnancy can improve health outcomes for women and their children. Current low-intensity psychological therapy for perinatal depression is a supported self-help approach informed by cognitive behavioural therapy (CBT) principles. Interpersonal counselling (IPC) may be a more appropriate low-intensity talking therapy for addressing the problems experienced by pregnant women with depression. A randomised feasibility trial (ADAGIO) has compared the acceptability of offering IPC for mild-moderate antenatal depression in routine NHS services compared to low-intensity CBT. This paper reports on a nested qualitative study which explored women's views and expectations of therapy, experiences of receiving IPC, and Psychological Wellbeing Practitioners (PWPs - junior mental health workers) views of delivering the low-intensity therapy.
METHODS


A qualitative study design using in-depth semi-structured interviews and focus groups. Thirty-two pregnant women received talking therapy within the ADAGIO trial; 19 contributed to the interview study from July 2019 to January 2020; 12 who had IPC and seven who had CBT. All six PWPs trained in IPC took part in a focus group or interview. Interviews and focus groups were recorded, transcribed, anonymised, and analysed using thematic methods.
RESULTS


Pregnant women welcomed being asked about their mental health in pregnancy and having the chance to have support in accessing therapy. The IPC approach helped women to identify triggers for depression and explored relationships using strategies such as 'promoting self-awareness through mood timelines', 'identifying their circles of support', 'developing communication skills and reciprocity in relationships', and 'asking for help'. PWPs compared how IPC differed from their prior experiences of delivering low-intensity CBT. They reported that IPC included a useful additional emotional component which was relevant to the perinatal period.
CONCLUSIONS


Identifying and treating depression in pregnancy is important for the future health of both mother and child. Low-intensity perinatal-specific talking therapies delivered by psychological wellbeing practitioners in routine NHS primary care services in England are acceptable to pregnant women with mild-moderate depression. The strategies used in IPC to manage depression, including identifying triggers for low mood, and communicating the need for help, may be particularly appropriate for the perinatal period.
TRIAL REGISTRATION


ISRCTN 11513120. 02/05/2019.",2021,Low-intensity perinatal-specific talking therapies delivered by psychological wellbeing practitioners in routine NHS primary care services in England are acceptable to pregnant women with mild-moderate depression.,"['pregnant women with depression', 'Thirty-two pregnant women received talking therapy within the ADAGIO trial; 19 contributed to the interview study from July 2019 to January 2020; 12 who had IPC and seven who had CBT', 'women with depression during pregnancy', 'Pregnant women', 'women and their children', ""women's views and expectations of therapy, experiences of receiving IPC, and Psychological Wellbeing Practitioners (PWPs - junior mental health workers"", 'pregnant women with mild-moderate depression']","['interpersonal counselling (IPC', 'low-intensity cognitive behavioural therapy (CBT', 'Low-intensity perinatal-specific talking therapies delivered by psychological wellbeing practitioners', 'Interpersonal counselling (IPC', 'Current low-intensity psychological therapy']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}]",[],32.0,0.0240993,Low-intensity perinatal-specific talking therapies delivered by psychological wellbeing practitioners in routine NHS primary care services in England are acceptable to pregnant women with mild-moderate depression.,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UK. Jenny.Ingram@bristol.ac.uk.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': ""O'Mahen"", 'Affiliation': 'Mood disorders Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Law', 'Affiliation': 'Anna Freud National Centre for Children and Families, London, UK.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Culpin', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK.'}]",BMC pregnancy and childbirth,['10.1186/s12884-021-04247-w']
2878,34764150,"Effects of 40 Hz transcranial alternating current stimulation (tACS) on cognitive functions of patients with Alzheimer's disease: a randomised, double-blind, sham-controlled clinical trial.",,2021,,"[""patients with Alzheimer's disease""]",['40 Hz transcranial alternating current stimulation (tACS'],['cognitive functions'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.845071,,"[{'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': ""Ningbo Kangning Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': ""Guangdong Key Laboratory of Non-human Primate Research, Guangdong-Hong Kong-Macau Institute of CNS Regeneration, Jinan University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Xingxing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Ningbo Kangning Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': ""Ningbo Kangning Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yiyao', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Guangdong Key Laboratory of Non-human Primate Research, Guangdong-Hong Kong-Macau Institute of CNS Regeneration, Jinan University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Cheng-Ying', 'Initials': 'CY', 'LastName': 'Zheng', 'Affiliation': ""Ningbo Kangning Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ""Ningbo Kangning Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': ""Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China ytf0707@126.com.""}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2021-326885']
2879,34764044,Efficacy of the early treatment with tocilizumab-hydroxychloroquine and tocilizumab-remdesivir in severe COVID-19 Patients.,"BACKGROUND


The effectiveness of the best combination between different antiviral and anti-inflammatory drugs stills an interest in the treatment of COVID19 infection.
PATIENTS AND METHODS


A prospective randomized cohort study comprised 108 adult patients with confirmed PCR COVID 19 infection with systemic hyper inflammation state, divided into two groups according to the treatment regimen, 56 in the tocilizumab- hydroxychloroquine (TCZ-HCQ) treatment, and 52 in the tocilizumab-remdesivir (TCZ-RMV) treatment. The first group received a combination of I.V. TCZ (400-800 mg every 24 h for only two doses) and HCQ (400 mg twice in the first day then 200 mg twice for 5 days) while the second group of patients received I.V. RMV of 200 mg on day 1 followed by 100 mg once daily infused over 60 min for 5 days with the same TCZ regimen used in the first group. All clinical parameters and laboratory investigations were assessed before and after treatment.
RESULTS


The CRP was significantly decreased while PaO 2 /FiO 2  (P/F) ratio post-treatment was significantly improved in both treatment groups. TCZ-HCQ group showed a significant decrease in the ferritin, LDH, and D. Dimer levels. The median days of hospitalization with interquartile range (IQR) were 10 (6-16) and 8 (5-12) for TCZ-HCQ and TCZ-RMV groups, respectively. The numbers of mechanically ventilated patients were 25 and 43 for TCZ-HCQ and TCZ-RMV groups, respectively. Therapeutic failure was about 26.8% in the TCZ-HCQ group and 30.8% in the TCZ-RMV group but there was no significant difference between both groups. Some complications were recognized only in TCZ-RMV following treatment including secondary bacterial infections (42.3%), myocarditis (15.4%), and finally pulmonary embolism (7.7%).
CONCLUSION


Efficacy of both TCZ-RMV and TCZ-HCQ combinations are observed in the treatment of severe COVID-19 patients; however the increased need for ICU or mechanical ventilation in the TCZ-RMV arm contributed to the appearance of cardiac and thrombotic events. The study was registered at the Clinical Trials registry (ClinicalTrials.gov; NCT04779047).",2021,The CRP was significantly decreased while PaO 2 /FiO 2  (P/F) ratio post-treatment was significantly improved in both treatment groups.,"['severe COVID-19 Patients', '108 adult patients with confirmed PCR COVID 19 infection with systemic hyper inflammation state', 'severe COVID-19 patients']","['TCZ-HCQ', 'tocilizumab- hydroxychloroquine (TCZ-HCQ) treatment, and 52 in the tocilizumab-remdesivir (TCZ-RMV) treatment', 'tocilizumab-hydroxychloroquine and tocilizumab-remdesivir', 'TCZ', 'RMV', 'HCQ', 'TCZ-RMV', 'TCZ-RMV and TCZ-HCQ']","['Therapeutic failure', 'finally pulmonary embolism', 'Efficacy', 'ferritin, LDH, and D. Dimer levels', 'median days of hospitalization with interquartile range (IQR', 'CRP']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",108.0,0.0513301,The CRP was significantly decreased while PaO 2 /FiO 2  (P/F) ratio post-treatment was significantly improved in both treatment groups.,"[{'ForeName': 'Rania M', 'Initials': 'RM', 'LastName': 'Sarhan', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-suef, Egypt. Electronic address: raniamohammad87@yahoo.com.'}, {'ForeName': 'Hadeer S', 'Initials': 'HS', 'LastName': 'Harb', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-suef, Egypt.'}, {'ForeName': 'Ahmed E', 'Initials': 'AE', 'LastName': 'Abou Warda', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, October 6 University, Giza, Egypt.'}, {'ForeName': 'Mounir M', 'Initials': 'MM', 'LastName': 'Salem-Bekhit', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, 11451, Saudi Arabia; Department of Microbiology and Immunology, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Faiyaz', 'Initials': 'F', 'LastName': 'Shakeel', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, 11451, Saudi Arabia.'}, {'ForeName': 'Sami Ali', 'Initials': 'SA', 'LastName': 'Alzahrani', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, 11451, Saudi Arabia.'}, {'ForeName': 'Yasmin M', 'Initials': 'YM', 'LastName': 'Madney', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-suef, Egypt.'}, {'ForeName': 'Marian S', 'Initials': 'MS', 'LastName': 'Boshra', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-suef, Egypt.'}]",Journal of infection and public health,['10.1016/j.jiph.2021.10.024']
2880,34764037,The impact of community pharmacy utilization of immunization information systems on vaccination rates: Results of a clustered randomized controlled trial.,"BACKGROUND


Adult immunization rates in the United States remain low. More convenient access to immunization information systems (IIS) may improve vaccination rates.
OBJECTIVE


The objective of this multilevel, clustered, randomized controlled study was to measure the impact of providing pharmacists with software and training to query IIS for patient vaccine history/recommendations on adult influenza, pneumococcal, herpes zoster, and Td/Tdap vaccination rates.
METHODS


California Rite Aid pharmacy districts were randomized into intervention/control groups using stratified randomization based on baseline influenza vaccination rates. Store demographic characteristics were collected at baseline (January 1-December 31, 2018). During follow-up (April 1, 2019-March 31, 2020), intervention group stores received access to ImmsLink, software that allows health care providers to review immunization records from IIS and identify a patient's recommended vaccinations. The difference-in-difference between intervention and control groups compared the changes in vaccination rates from baseline to follow-up by calculating adjusted ratios of risk ratios (RRRs). Analysis was performed at the store level.
RESULTS


Thirty-six districts comprising 501 Rite Aid stores (intervention: n = 244 stores; control: n = 257) were included. We found no significant differences in vaccination rates between groups: influenza, 19-64 years (adjusted RRR 0.99 [95% CI 0.83-1.17]); influenza, ≥65 years (1.02 [0.86-1.22]); herpes zoster (1.07 [0.90-1.28]); pneumococcal (0.95, 0.80-1.14); and Td/Tdap (0.88, 0.73-1.05). Reasons that recommended vaccines were not given in the intervention group included patient being deferred to future visit, patient declining, patient having already received the vaccination, patient declining because of cost, or vaccine being unavailable. Overall, pharmacist engagement with ImmsLink was low.
CONCLUSION


Providing pharmacists with software and training to query IIS did not improve vaccination rates compared with control pharmacies in this study. Factors such as an inconvenient interface or inadequate training or motivation may have caused low engagement with the software and should be considered in future interventions.",2021,"CONCLUSION


Providing pharmacists with software and training to query IIS did not improve vaccination rates compared with control pharmacies in this study.","['Thirty-six districts comprising 501 Rite Aid stores (intervention: n\xa0= 244 stores; control: n\xa0= 257) were included', 'California Rite Aid pharmacy districts']","[""intervention group stores received access to ImmsLink, software that allows health care providers to review immunization records from IIS and identify a patient's recommended vaccinations"", 'immunization information systems']","['vaccination rates', 'herpes zoster']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4273868', 'cui_str': 'Immunization record'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}]",501.0,0.224849,"CONCLUSION


Providing pharmacists with software and training to query IIS did not improve vaccination rates compared with control pharmacies in this study.","[{'ForeName': 'Pamela C', 'Initials': 'PC', 'LastName': 'Heaton', 'Affiliation': ''}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Altstadter', 'Affiliation': ''}, {'ForeName': 'Cosmina', 'Initials': 'C', 'LastName': 'Hogea', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Poston', 'Affiliation': ''}, {'ForeName': 'Parinaz', 'Initials': 'P', 'LastName': 'Ghaswalla', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2021.09.010']
2881,34764014,Effect of acupressure at the BL67 spot on the spontaneous rotation of fetus with breech presentation: A randomized controlled trial.,"BACKGROUND


Breech is a common fetal presentation in preterm pregnancies. This study aimed to investigate the effect of acupressure at the BL67 point on the spontaneous rotation of fetus with breech presentation.
METHODS


An unblind, two-armed randomized controlled trial was carried out from September 2017 to April 2020. Research participants were 138 pregnant women at 32 to 35 weeks of gestational age that had fetal breech presentation confirmed by ultrasound. They were randomly assigned into intervention and control groups (n=69 in each group). The intervention group received acupressure at the BL67 point on both feet for 10 minutes daily and for two consecutive weeks. The control group received routine care. Demographic and midwifery data questionnaires were used for data collection.
RESULTS


The spontaneous rotation of fetus with breech presentation into cephalic was observed in the majority of participants in the intervention group (82.6%) compared to the control group (17.4%) (p<0.001). Statistically significant differences in the fetal presentation at delivery was observed between the groups (84.1% cephalic vs. 18.8% breech, p<0.001). Regarding the type of delivery, cesarean section was reported mostly (85.5%) in the control group compared to the intervention group (21.7%) (p<0.001). However, the first- and fifth-minute Apgar scores of newborns had no statistically significant differences between the groups (p=0.773).
CONCLUSION


It is suggested to incorporate acupressure at the BL67 point into the care process for pregnant women to help with the reduction of the rate of cesarean section and avoid its related complications.",2021,The spontaneous rotation of fetus with breech presentation into cephalic was observed in the majority of participants in the intervention group (82.6%) compared to the control group (17.4%) (p<0.001).,"['An unblind, two-armed randomized controlled trial was carried out from September 2017 to April 2020', 'preterm pregnancies', 'fetus with breech presentation', '138 pregnant women at 32 to 35 weeks of gestational age that had fetal breech presentation confirmed by ultrasound', 'pregnant women']","['acupressure', 'BL67 spot', 'routine care', 'acupressure at the BL67 point']","['type of delivery, cesarean section', 'spontaneous rotation of fetus with breech presentation into cephalic', 'fetal presentation at delivery']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0006157', 'cui_str': 'Breech presentation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0006157', 'cui_str': 'Breech presentation'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0022869', 'cui_str': 'Presentation of fetus'}]",138.0,0.0796401,The spontaneous rotation of fetus with breech presentation into cephalic was observed in the majority of participants in the intervention group (82.6%) compared to the control group (17.4%) (p<0.001).,"[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Hamidzadeh', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: azhamidzade@gmail.com.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Tavakol', 'Affiliation': 'Community-Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: zeinab.tavakol@yahoo.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Pediatric and Neonatal Intensive Care Nursing Education Department, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: maleki-m@razi.tums.ac.ir.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Kolahdozan', 'Affiliation': 'Sexual Health and Fertility Research Center, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: sakolahdozan@gmail.com.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Khosravi', 'Affiliation': 'Center for Health related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: ahmadkhosravi225@gmail.com.'}, {'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Kiani', 'Affiliation': 'School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: kiani@shmu.ac.ir.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, Bodø, Norway. Electronic address: mojtaba.vaismoradi@nord.no.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2021.10.005']
2882,34763950,A single blind randomized phase 3 study to evaluate safety and immunogenicity of inactivated hepatitis A vaccine (HAPIBEV TM ) in 1-15 years-old healthy hepatitis A vaccine-naïve children.,"The Biological E inactivated hepatitis A (HAPIBEV™) vaccine was developed by importing the Healive® vaccine bulk from China and fill-finish it in India. Healive® vaccine is approved in China for both children and adults. This study assessed the safety and immunogenicity of HAPIBEV™ vaccine as compared to the Havrix 720® vaccine of GlaxoSmithKline (GSK) pharmaceuticals when administered intramuscularly (IM) 6 months apart in 1-15 years old hepatitis A virus (HAV) vaccine naive children in India. This Phase 3, single blind, parallel, randomized, active-controlled, two-arm study was conducted at 8 centers in India in healthy HAV vaccine-naive children. Subjects were stratified into 2 age subsets (1-7 and 8-15 years) and randomly assigned to either BE-HAPIBEV™ or GSK's Havrix® vaccine and administered 2 IM injections 6 months apart. The immunogenicity evaluations included: (1) proportion of subjects who achieved the following at Day 210 from baseline: (a) seroconversion (≥20 mIU/mL) with anti-HAV immunoglobulin G (IgG) antibodies, (b) ≥4-fold increase in anti-HAV IgG antibodies, and (c) ≥2-fold increase in anti-HAV IgG antibodies concentration who were already seroconverted at baseline and (2) geometric mean concentrations (GMC) of anti-HAV IgG antibodies at baseline and Day 210. Safety was evaluated throughout the study. A total of 467 (89.8%) subjects completed the study. The non-inferiority criterion was met by HAPIBEV™ vaccine as seroconversion rates in both vaccine groups were 100%. Overall, other immunogenicity evaluations were either similar in both vaccine groups or higher in the HAPIBEV™ group compared with the Havrix® group. The safety profile was also comparable between HAPIBEV™ and Havrix® groups. The most common adverse event (AE) was injection site pain, and the majority of AEs were mild in severity. The HAPIBEV™ vaccine demonstrated an immunological and safety profile on par with Havrix® in 1-15 years old healthy HAV vaccine-naive Indian children. This study is registered with clinical trial registry of India bearing no: CTRI/2019/04/018384 on 02 Apr 2019.",2021,The HAPIBEV™ vaccine demonstrated an immunological and safety profile on par with Havrix® in 1-15 years old healthy HAV vaccine-naive Indian children.,"['children and adults', '1-15\xa0years-old healthy hepatitis A vaccine-naïve children', '1-15\xa0years old healthy HAV vaccine-naive Indian children', '6\xa0months apart in 1-15\xa0years old hepatitis A virus (HAV) vaccine naive children in India', 'A total of 467 (89.8%) subjects completed the study', 'Subjects were stratified into 2 age subsets (1-7 and 8-15\xa0years', '8 centers in India in healthy HAV vaccine-naive children']","['Healive® vaccine', 'inactivated hepatitis A vaccine (HAPIBEV TM ', 'GlaxoSmithKline (GSK', ""BE-HAPIBEV™ or GSK's Havrix® vaccine and administered 2 IM injections 6\xa0months apart""]","['immunogenicity evaluations', 'safety profile', 'geometric mean concentrations (GMC) of anti-HAV IgG antibodies', 'seroconversion rates', 'Safety', 'anti-HAV immunoglobulin G (IgG) antibodies, (b) ≥4-fold increase in anti-HAV IgG antibodies, and (c) ≥2-fold increase in anti-HAV IgG antibodies concentration', 'safety and immunogenicity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0170300', 'cui_str': 'Hepatitis A Vaccine'}, {'cui': 'C0795623', 'cui_str': 'Hepatitis A Vaccine, Inactivated'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376325', 'cui_str': 'Hepatitis A Virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0795623', 'cui_str': 'Hepatitis A Vaccine, Inactivated'}, {'cui': 'C0700881', 'cui_str': 'Havrix'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376325', 'cui_str': 'Hepatitis A Virus'}, {'cui': 'C1292065', 'cui_str': 'Immunoglobulin G (IgG) antibody'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.180618,The HAPIBEV™ vaccine demonstrated an immunological and safety profile on par with Havrix® in 1-15 years old healthy HAV vaccine-naive Indian children.,"[{'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Thuluva', 'Affiliation': 'Biological E Limited, 18/1&3, Azamabad, Hyderabad 500 020, Telangana, India. Electronic address: subhash.thuluva@biologicale.com.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Matur', 'Affiliation': 'Biological E Limited, 18/1&3, Azamabad, Hyderabad 500 020, Telangana, India.'}, {'ForeName': 'Kishore', 'Initials': 'K', 'LastName': 'Tsa', 'Affiliation': 'Biological E Limited, 18/1&3, Azamabad, Hyderabad 500 020, Telangana, India.'}, {'ForeName': 'Subba Reddy', 'Initials': 'SR', 'LastName': 'Gv', 'Affiliation': 'Biological E Limited, 18/1&3, Azamabad, Hyderabad 500 020, Telangana, India.'}]",Vaccine,['10.1016/j.vaccine.2021.10.018']
2883,34763939,Challenges in lower limb lymphoedema assessment based on limb volume change: Lessons learnt from the SENTIX prospective multicentre study.,"BACKGROUND


Lower limb lymphoedema (LLL) is the most disabling adverse effect of surgical staging of pelvic lymph nodes. However, the lack of standardisation of volumetric LLL assessment hinders direct comparison between the studies and makes LLL reporting unreliable. The aim of our study is to report outcomes from a prospective trial that have implications for LLL assessment standardisation.
METHODS


In the prospective international multicentre trial SENTIX, a group of 150 patients with stage IA1-IB2 cervical cancer treated by uterine surgery with bilateral sentinel lymph node biopsy was prospectively evaluated by objective LLL assessment, based on limb volume change (LVC) using circumferrential limb measurements and subjective patient-reported swelling. The assessments were conducted in six-month periods over 24 months post-surgery.
RESULTS


Patient LVC substantially fluctuated in both positive and negative directions, which were comparable in frequency up to ±14% change. Thirty-eight patients experienced persistent LVC increase >10% classified as LLL, with nine months median time to onset. Some 34.2% of cases experienced onset later than one year after the surgery. Thirty-three patients (22%) experienced transient oedema characterised as LVC >10%, which resolved without intervention between two consequent follow-up visits. No significant correlation between LVC >10% and a patient-reported swelling was observed.
CONCLUSIONS


Given that we observed comparable fluctuations of the the lower-limb volumes after surgical treatment of cervical cancer in both positive and negative direction up to ±14%, the diagnostic threshold for LLL diagnosis based on LVC should be increased to >15% LVC. The distinction of transient oedema from persistent LLL requires repeated measurements. Also, as one-third of LLL cases are diagnosed >1-year post-surgery, a sufficient follow-up duration needs to be ensured. Patient-reported swelling correlated poorly with LVC and should only be used as an adjunct to objective LLL assessment.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02494063.",2021,"Thirty-three patients (22%) experienced transient oedema characterised as LVC >10%, which resolved without intervention between two consequent follow-up visits.",['150 patients with stage IA1-IB2 cervical cancer treated by'],['uterine surgery with bilateral sentinel lymph node biopsy'],"['persistent LVC', 'lower-limb volumes', 'transient oedema']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C3665370', 'cui_str': 'Operation on uterus'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0333244', 'cui_str': 'Transient edema'}]",150.0,0.0237275,"Thirty-three patients (22%) experienced transient oedema characterised as LVC >10%, which resolved without intervention between two consequent follow-up visits.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Borčinová', 'Affiliation': 'Gynecologic Oncology Centre, Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital, Central and Eastern European Gynecologic Oncology Group, CEEGOG, Prague, Czech Republic.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Ragosch', 'Affiliation': 'Department of Special Operative and Oncologic Gynaecology, Asklepios-Clinic Hamburg, Hamburg, Germany.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Jarkovský', 'Affiliation': 'Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Sylva', 'Initials': 'S', 'LastName': 'Bajsová', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Ostrava, Central and Eastern European Gynecologic Oncology Group, CEEGOG, Ostrava Poruba, Czech Republic.'}, {'ForeName': 'Radovan', 'Initials': 'R', 'LastName': 'Pilka', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine and Dentistry, Palacky University, University Hospital Olomouc, Central and Eastern European Gynecologic Oncology Group, CEEGOG, Olomouc, Czech Republic.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Glickman', 'Affiliation': ""Unit of Gynecological Oncology, Institute Clinic of Gynaecology, Obstetrics, and Neonatology, Hospital Clinic-Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Garrido-Mallach', 'Affiliation': 'Gynecologic Oncology Unit, La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Fondazione IRCCS Instituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Wiktor', 'Initials': 'W', 'LastName': 'Szatkowski', 'Affiliation': 'M. Sklodowska-Curie Memorial Institute, Krakow, Poland.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pakiz', 'Affiliation': 'University medical Centre Maribor, Slovenia.'}, {'ForeName': 'Leon C', 'Initials': 'LC', 'LastName': 'Snyman', 'Affiliation': 'Kalafong Provincial Tertiary Hospital, South Africa.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Kocián', 'Affiliation': 'Gynecologic Oncology Centre, Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital, Central and Eastern European Gynecologic Oncology Group, CEEGOG, Prague, Czech Republic.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Tamussino', 'Affiliation': 'Medical University Graz, Austria.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Kalist', 'Affiliation': 'Krajská nemocnice T. Bati, A.S., Zlín, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Michal', 'Affiliation': 'Nemocnice České Budějovice, Czech Republic.'}, {'ForeName': 'Myriam Gracia', 'Initials': 'MG', 'LastName': 'Segovia', 'Affiliation': 'Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Poka', 'Affiliation': 'Department of obstetrics and Gynecology, University of Debrecen, Hungary.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kipp', 'Affiliation': 'Neue Freuenklinik, Luzerner Kantonsspital, Switzerland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Szewczyk', 'Affiliation': 'Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Wydra', 'Affiliation': 'The University Clinical Centre in Gdansk, Poland.'}, {'ForeName': 'Róbert', 'Initials': 'R', 'LastName': 'Tóth', 'Affiliation': 'Oncology Institute of East Slovakia, Košice, Slovakia.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Vinnytska', 'Affiliation': 'LISOD - Israeli Oncological Hospital, Plyuty, Ukraine.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fischerová', 'Affiliation': 'Gynecologic Oncology Centre, Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital, Central and Eastern European Gynecologic Oncology Group, CEEGOG, Prague, Czech Republic.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Siegler', 'Affiliation': 'Department of Special Operative and Oncologic Gynaecology, Asklepios-Clinic Hamburg, Hamburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cibula', 'Affiliation': 'Gynecologic Oncology Centre, Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital, Central and Eastern European Gynecologic Oncology Group, CEEGOG, Prague, Czech Republic. Electronic address: dc@davidcibula.cz.'}]",Gynecologic oncology,['10.1016/j.ygyno.2021.10.089']
2884,34763937,"Phase II study of enzalutamide in androgen receptor positive, recurrent, high- and low-grade serous ovarian cancer.","OBJECTIVES


We sought to determine the safety and efficacy of the oral androgen receptor antagonist enzalutamide in patients with previously treated, recurrent, AR-positive (AR+) ovarian cancer.
METHODS


This was a single-institution phase II study of patients with AR+ ovarian cancer with measurable disease with 1-3 prior lines of chemotherapy; patients were screened for enrollment from 11/2013-7/2018. Following consent, archival tissue was evaluated for AR+. Enrolled patients received daily enzalutamide 160 mg until progression of disease or treatment discontinuation. Adverse events were graded by CTCAE v4.0. Co-primary endpoints were 6-month progression-free survival (PFS 6 ) and overall response rate (ORR) by RECIST 1.1 criteria.
RESULTS


During the study period, 160 patients were screened and 59 (45 high-grade serous [HGS] and 14 low-grade serous [LGS]) consented to treatment on study. There was 1 confirmed and 1 unconfirmed partial response. The ORR was 1.7% (90% CI: 0.2-100%). The overall PFS 6  rate (as binary) was 22% (90% CI: 15.1-100%). The 6-month PFS rate (as time to event) was 19.8% for HGS patients (90% CI: 12.7-100%) and 38.5% (90% CI: 21.7%-100%) for LGS patients. Grade 3 toxicities occurred in 6 patients (one toxicity (Grade 3 rash) was considered a dose-limiting toxicity). One patient died of cardiac arrest after 42 days on treatment of a cardiac arrest not attributed to study drug.
CONCLUSIONS


The study met its primary endpoint, with a PFS 6  rate of 22% (n = 13); however, the overall response rate was low. Enzalutamide was well tolerated and may be a potential treatment option in select patients.",2021,The overall PFS 6  rate (as binary) was 22% (90% CI: 15.1-100%).,"['androgen receptor positive, recurrent, high- and low-grade serous ovarian cancer', '160 patients were screened and 59 (45 high-grade serous [HGS] and 14 low-grade serous [LGS]) consented to treatment on study', 'patients with previously treated, recurrent, AR-positive (AR+) ovarian cancer', 'patients with AR+ ovarian cancer with measurable disease with 1-3 prior lines of chemotherapy; patients were screened for enrollment from 11/2013-7/2018']","['daily enzalutamide 160\xa0mg until progression of disease or treatment discontinuation', 'enzalutamide', 'oral androgen receptor antagonist enzalutamide', 'Enzalutamide']","['6-month PFS rate', 'Adverse events', 'ORR', 'safety and efficacy', 'overall response rate', 'overall PFS 6  rate', 'Grade 3 toxicities', '6-month progression-free survival (PFS 6 ) and overall response rate (ORR']","[{'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2936804', 'cui_str': 'Androgen Receptor Antagonists'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",160.0,0.0715423,The overall PFS 6  rate (as binary) was 22% (90% CI: 15.1-100%).,"[{'ForeName': 'Beryl L', 'Initials': 'BL', 'LastName': 'Manning-Geist', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Sushmita B', 'Initials': 'SB', 'LastName': 'Gordhandas', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Dilip D', 'Initials': 'DD', 'LastName': 'Giri', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Iasonos', 'Affiliation': 'Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Girshman', 'Affiliation': 'Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA; Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Roisin E', 'Initials': 'RE', 'LastName': ""O'Cearbhaill"", 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Dmitriy', 'Initials': 'D', 'LastName': 'Zamarin', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Lichtman', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Sabbatini', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Tew', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Autumn S', 'Initials': 'AS', 'LastName': 'McDonnell', 'Affiliation': 'Research and Technology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Emeline M', 'Initials': 'EM', 'LastName': 'Aviki', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Chi', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Aghajanian', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Grisham', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA. Electronic address: grishamr@mskcc.org.'}]",Gynecologic oncology,['10.1016/j.ygyno.2021.10.087']
2885,34764381,Bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial.,"Normoferritinemic women with functional hyperandrogenism show a mild iron overload. Iron excess, hyperandrogenism, and cardioautonomic dysfunction contribute to blood pressure (BP) abnormalities in these patients. Furthermore, combined oral contraceptives (COC) prescribed for hyperandrogenic symptoms may worse BP recordings. Iron depletion by phlebotomy appears to lower BP in other acquired iron overload conditions. We aimed to determine the effect of iron depletion on the office BP, ambulatory BP monitoring, and frequency of hypertension in patients with functional hyperandrogenism submitted to standard therapy with COC. We conducted a phase 2 randomized, controlled, parallel, open-label clinical trial (NCT02460445) in adult women with functional hyperandrogenism including hyperandrogenic polycystic ovary syndrome and idiopathic hyperandrogenism. After a 3-month run-in period of treatment with 35 µg ethinylestradiol plus 2 mg cyproterone acetate, participants were randomized (1:1) to three scheduled bloodlettings or observation for another 9 months. Main outcome measures were the changes in office BP, 24-h-ambulatory BP, and frequency of hypertension in both study arms. From June 2015 to June 2019, 33 women were included in the intention-to-treat analyses. We observed an increase in mean office systolic BP [mean of the differences (MD): 2.5 (0.3-4.8) mmHg] and night-time ambulatory systolic BP [MD 4.1 (1.4-6.8) mmHg] after 3 months on COC. The percentage of nocturnal BP non-dippers also increased, from 28.1 to 92.3% (P < 0.001). Office and ambulatory BP did not change throughout the experimental period of the trial, both when considering all women as a whole or as a function of the study arm. The frequency of the non-dipping pattern in BP decreased during the experimental period [OR 0.694 (0.577-0.835), P < 0.001], regardless of the study arm. Decreasing iron stores by scheduled bloodletting does not override the BP abnormalities caused by COC in women with functional hyperandrogenism.",2021,"Office and ambulatory BP did not change throughout the experimental period of the trial, both when considering all women as a whole or as a function of the study arm.","['hyperandrogenic women taking oral contraceptives', 'patients with functional hyperandrogenism submitted to standard therapy with COC', 'Normoferritinemic women with functional hyperandrogenism show a mild iron overload', 'women with functional hyperandrogenism', 'adult women with functional hyperandrogenism including hyperandrogenic polycystic ovary syndrome and idiopathic hyperandrogenism', 'From June 2015 to June 2019, 33 women were included in the intention-to-treat analyses']","['combined oral contraceptives (COC', 'ethinylestradiol plus 2\xa0mg cyproterone acetate']","['Office and ambulatory BP', 'mean office systolic BP', 'blood pressure (BP) abnormalities', 'office BP, ambulatory BP monitoring, and frequency of hypertension', 'night-time ambulatory systolic BP', 'blood pressure abnormalities', 'changes in office BP, 24-h-ambulatory BP, and frequency of hypertension', 'percentage of nocturnal BP non-dippers', 'frequency of the non-dipping pattern in BP', 'Decreasing iron stores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0206081', 'cui_str': 'Hyperandrogenization syndrome'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0282193', 'cui_str': 'Iron overload'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0056855', 'cui_str': 'Cyproterone acetate'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0326560', 'cui_str': 'Cinclidae'}, {'cui': 'C0337426', 'cui_str': 'Dipping'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}]",33.0,0.1089,"Office and ambulatory BP did not change throughout the experimental period of the trial, both when considering all women as a whole or as a function of the study arm.","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Luque-Ramírez', 'Affiliation': 'Diabetes, Obesity, and Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) and Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain. manuel.luque@salud.madrid.org.'}, {'ForeName': 'Andrés E', 'Initials': 'AE', 'LastName': 'Ortiz-Flores', 'Affiliation': 'Diabetes, Obesity, and Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) and Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Lía', 'Initials': 'L', 'LastName': 'Nattero-Chávez', 'Affiliation': 'Diabetes, Obesity, and Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) and Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Martínez-García', 'Affiliation': 'Diabetes, Obesity, and Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) and Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Insenser', 'Affiliation': 'Diabetes, Obesity, and Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) and Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Álvarez-Blasco', 'Affiliation': 'Diabetes, Obesity, and Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) and Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fernández-Durán', 'Affiliation': 'Diabetes, Obesity, and Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) and Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Quintero-Tobar', 'Affiliation': 'Diabetes, Obesity, and Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) and Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'de Lope Quiñones', 'Affiliation': 'Diabetes, Obesity, and Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) and Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Héctor F', 'Initials': 'HF', 'LastName': 'Escobar-Morreale', 'Affiliation': 'Diabetes, Obesity, and Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) and Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain.'}]",Scientific reports,['10.1038/s41598-021-01606-7']
2886,34764377,Comparison of nasal patency after nose-blowing between pinch versus no pinch method: a randomized controlled trial.,"We proposed that nose-blowing without pinching was safer and able to get rid of mucus and maintain nasal patency as effective as the pinch and blow method. The objective of this study was to evaluate the nasal patency after nose-blowing by pinching the nose versus no pinching. The patients who have nasal discharge such as allergic rhinitis or common cold were recruited. The patients were randomized to perform pinching or no pinching nose-blowing. Fifty patients were enrolled in this study. The objective evaluation using acoustic rhinometry found no difference in nasal patency between the two groups (p > 0.05). The subjective patency score was significantly higher in the pinch one nostril shut group (mean difference 0.88, 95% CI 0.20-1.55). The patency of the two methods were comparable according to the objective test. However, the patients felt that their nose was clearer when pinching and blowing.",2021,The objective evaluation using acoustic rhinometry found no difference in nasal patency between the two groups (p > 0.05).,"['Fifty patients were enrolled in this study', 'patients who have nasal discharge such as allergic rhinitis or common cold were recruited']",['pinching or no pinching nose-blowing'],"['subjective patency score', 'nasal patency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}]","[{'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",50.0,0.0319894,The objective evaluation using acoustic rhinometry found no difference in nasal patency between the two groups (p > 0.05).,"[{'ForeName': 'Patorn', 'Initials': 'P', 'LastName': 'Piromchai', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, Thailand. patorn@kku.ac.th.'}, {'ForeName': 'Jakkrit', 'Initials': 'J', 'LastName': 'Netnoi', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Supaporn', 'Initials': 'S', 'LastName': 'Srirompotong', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Panida', 'Initials': 'P', 'LastName': 'Thanawirattananit', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, Thailand.'}]",Scientific reports,['10.1038/s41598-021-01631-6']
2887,34764311,A structured exercise to relieve musculoskeletal pain caused by face-down posture after retinal surgery: a randomized controlled trial.,"Face-down posture after vitrectomy physically burdens patients. Despite being of significant concern for patients, the intraoperative pain and discomfort has not been of great interest to retinal surgeons or researchers. This randomized controlled trial evaluated the effect of a 3-day novel structured exercise on reducing musculoskeletal pain from the face-down posture in 61 participants (31 in the exercise group) who underwent vitrectomy. Among the subjects, the median age was 62 years, 42 were female, 42 had macular holes, and 19 had retinal detachments. Participants in the exercise group received initial education on the exercise and performed three daily active exercise sessions. After the sessions, the exercise group had median numeric pain scores of 2, 1, and 1 at the back neck, shoulder, and lower back, respectively, while the control group had corresponding scores of 5, 3, and 4, respectively. The exercise group reported significantly lower pain scores (P = .003, .039, and .006 for the back neck, shoulder, and lower back, respectively). Application of the structured exercise would alleviate the patients' position-induced postoperative physical burden, by reducing pain and discomfort.",2021,"The exercise group reported significantly lower pain scores (P = .003, .039, and .006 for the back neck, shoulder, and lower back, respectively).","['Among the subjects, the median age was 62\xa0years, 42 were female, 42 had macular holes, and 19 had retinal detachments', '61 participants (31 in the exercise group) who underwent']","['initial education on the exercise and performed three daily active exercise sessions', 'vitrectomy', 'structured exercise', '3-day novel structured exercise']","['musculoskeletal pain', 'pain and discomfort', 'median numeric pain scores', 'lower pain scores']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0035305', 'cui_str': 'Retinal detachment'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0419117', 'cui_str': 'Active exercise'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.0359106,"The exercise group reported significantly lower pain scores (P = .003, .039, and .006 for the back neck, shoulder, and lower back, respectively).","[{'ForeName': 'A-Young', 'Initials': 'AY', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, #81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Sungsoon', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, #81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Se Woong', 'Initials': 'SW', 'LastName': 'Kang', 'Affiliation': 'Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, #81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea. kangsewoong@gmail.com.'}, {'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Shin', 'Affiliation': 'Department of Nursing, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Won Hyuk', 'Initials': 'WH', 'LastName': 'Chang', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, #81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Noh', 'Affiliation': 'Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, #81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}]",Scientific reports,['10.1038/s41598-021-01182-w']
2888,34764215,Impact of Dietary Intervention on Serum Neurofilament Light Chain in Multiple Sclerosis.,"BACKGROUND AND OBJECTIVES


Adapted ketogenic diet (AKD) and caloric restriction (CR) have been suggested as alternative therapeutic strategies for multiple sclerosis (MS), but information on their impact on neuroaxonal damage is lacking. Thus, we explored the impact of diets on serum neurofilament light chain (sNfL) levels in patients with relapsing-remitting MS.
METHODS


We retrospectively evaluated a prospective randomized controlled trial of 60 patients with MS who were on a common diet or ketogenic diet or fasting. We examined sNfL levels of 40 participants at baseline and at the end of the study after 6 months using single molecule array assay.
RESULTS


sNfL levels were investigated in 9 controls, 14 participants on CR, and 17 participants on AKD. Correlation analysis showed an association of sNfL with age and disease duration; an association was also found between sNfL and the Multiple Sclerosis Functional Composite. AKD significantly reduced sNfL levels at 6 months compared with the common diet group ( p  = 0.001).
DISCUSSION


For clinical or study use, consider that AKD may incline sNfL levels independent of relapse activity up to 3 months after initiation. At 6 months, AKD, which complements current therapies, reduced sNfL levels, therefore suggesting potential neuroprotective effects in MS. A single cycle of seven-day fasting did not affect sNfL. AKD may be an addition to the armamentarium to help clinicians support patients with MS in a personalized manner with tailored diet strategies.
TRIAL REGISTRATION INFORMATION


Clinical trial registration number NCT01538355.",2022,"AKD significantly reduced sNfL levels at 6 months compared with the common diet group ( p  = 0.001).
","['60 patients with MS who were on a common diet or ketogenic diet or fasting', '40 participants at baseline and at the end of the study after 6 months using single molecule array assay', 'Multiple Sclerosis', '14 participants on CR, and 17 participants on AKD', 'patients with relapsing-remitting MS']","['ketogenic diet (AKD) and caloric restriction (CR', 'Dietary Intervention']","['serum neurofilament light chain (sNfL) levels', 'sNfL levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1562562', 'cui_str': 'Light chain level'}]",60.0,0.0279165,"AKD significantly reduced sNfL levels at 6 months compared with the common diet group ( p  = 0.001).
","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bock', 'Affiliation': 'From the Department of Neurology (M.B., F.S., F.Z., S.B.), Focus Program Translational Neuroscience (FTN) and Immunotherapy (FZI), Rhine Main Neuroscience Network (rmn2), University Medical Center of the Johannes Gutenberg University Mainz; Institute of Biochemistry (M.B.), University Medicine Berlin-Charité, Germany; and Experimental & Clinical Research Center (ECRC) A Joint Cooperation of Charité Medical Faculty and Max-Delbrueck-Center for Molecular Medicine (MDC) (M.B.). markus.bock@posteo.de.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Steffen', 'Affiliation': 'From the Department of Neurology (M.B., F.S., F.Z., S.B.), Focus Program Translational Neuroscience (FTN) and Immunotherapy (FZI), Rhine Main Neuroscience Network (rmn2), University Medical Center of the Johannes Gutenberg University Mainz; Institute of Biochemistry (M.B.), University Medicine Berlin-Charité, Germany; and Experimental & Clinical Research Center (ECRC) A Joint Cooperation of Charité Medical Faculty and Max-Delbrueck-Center for Molecular Medicine (MDC) (M.B.).'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Zipp', 'Affiliation': 'From the Department of Neurology (M.B., F.S., F.Z., S.B.), Focus Program Translational Neuroscience (FTN) and Immunotherapy (FZI), Rhine Main Neuroscience Network (rmn2), University Medical Center of the Johannes Gutenberg University Mainz; Institute of Biochemistry (M.B.), University Medicine Berlin-Charité, Germany; and Experimental & Clinical Research Center (ECRC) A Joint Cooperation of Charité Medical Faculty and Max-Delbrueck-Center for Molecular Medicine (MDC) (M.B.).'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bittner', 'Affiliation': 'From the Department of Neurology (M.B., F.S., F.Z., S.B.), Focus Program Translational Neuroscience (FTN) and Immunotherapy (FZI), Rhine Main Neuroscience Network (rmn2), University Medical Center of the Johannes Gutenberg University Mainz; Institute of Biochemistry (M.B.), University Medicine Berlin-Charité, Germany; and Experimental & Clinical Research Center (ECRC) A Joint Cooperation of Charité Medical Faculty and Max-Delbrueck-Center for Molecular Medicine (MDC) (M.B.).'}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000001102']
2889,34764195,Adjuvant pembrolizumab versus interferon alfa-2b or ipilimumab in resected high-risk melanoma.,"We conducted a randomized phase 3 trial to evaluate whether adjuvant pembrolizumab for one year (648 patients) improved recurrence-free survival (RFS) or overall survival (OS) in comparison to high-dose interferon alfa-2b for one year or ipilimumab for up to three years (655 patients), the approved standard-of-care adjuvant immunotherapies at the time of enrollment for patients with high-risk resected melanoma. At a median follow-up of 47.5 months, pembrolizumab was associated with significantly longer RFS than prior standard-of-care adjuvant immunotherapies (hazard ratio [HR] 0.77; 99.62% confidence interval [CI] 0.59-0.99; P=0.002). There was no statistically significant association with OS among all patients (HR, 0.82; 96.3% CI 0.61-1.09; P=0.15). Proportions of treatment-related adverse events of grades 3 to 5 were 19.5% with pembrolizumab, 71.2% with interferon alfa-2b, and 49.2% with ipilimumab. Therefore, adjuvant pembrolizumab significantly improved RFS but not OS compared to the prior standard-of-care immunotherapies for patients with high-risk resected melanoma.",2021,"There was no statistically significant association with OS among all patients (HR, 0.82; 96.3% CI 0.61-1.09; P=0.15).","['patients with high-risk resected melanoma', 'resected high-risk melanoma']","['interferon alfa-2b for one year or ipilimumab', 'Adjuvant pembrolizumab versus interferon alfa-2b or ipilimumab', 'adjuvant pembrolizumab', 'ipilimumab']","['recurrence-free survival (RFS) or overall survival (OS', 'RFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]","[{'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.250705,"There was no statistically significant association with OS among all patients (HR, 0.82; 96.3% CI 0.61-1.09; P=0.15).","[{'ForeName': 'Kenneth F', 'Initials': 'KF', 'LastName': 'Grossmann', 'Affiliation': 'Internal Medicine, Division of Medical Oncology, Huntsman Cancer Institute.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Othus', 'Affiliation': 'SWOG Statistical Center, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Sapna P', 'Initials': 'SP', 'LastName': 'Patel', 'Affiliation': 'Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Tarhini', 'Affiliation': 'Cutaneous Oncology and Immunology, H. Lee Moffitt Cancer Center and Research Institute.'}, {'ForeName': 'Vernon K', 'Initials': 'VK', 'LastName': 'Sondak', 'Affiliation': 'Cutaneous Oncology, Moffitt Cancer Center.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Knopp', 'Affiliation': 'Radiology, OSU.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Petrella', 'Affiliation': 'Toronto, Canada.'}, {'ForeName': 'Thach-Giao', 'Initials': 'TG', 'LastName': 'Truong', 'Affiliation': 'Kaiser Permanente.'}, {'ForeName': 'Nikhil I', 'Initials': 'NI', 'LastName': 'Khushalani', 'Affiliation': 'Cutaneous Oncology, Moffitt Cancer Center.'}, {'ForeName': 'Justine V', 'Initials': 'JV', 'LastName': 'Cohen', 'Affiliation': 'Medicine, Massachusetts General Hospital.'}, {'ForeName': 'Elizabeth I', 'Initials': 'EI', 'LastName': 'Buchbinder', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kendra', 'Affiliation': 'Division of Internal Medicine, The Ohio State University.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Funchain', 'Affiliation': 'Taussig Cancer Institute, Cleveland Clinic.'}, {'ForeName': 'Karl D', 'Initials': 'KD', 'LastName': 'Lewis', 'Affiliation': 'School of Medicine, Division of Medical Oncology, University of Colorado Denver.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Conry', 'Affiliation': 'Clearview Cancer Institute.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Chmielowski', 'Affiliation': 'Hematology - Medical Oncology, Jonsson Comprehensive Cancer Center, University of California, Los Angeles.'}, {'ForeName': 'Ragini R', 'Initials': 'RR', 'LastName': 'Kudchadkar', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Vanderbilt-Ingram Cancer Center.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Fred Hutchinson/University of Washington Cancer Consortium.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Eroglu', 'Affiliation': 'Cutaneous Oncology, Moffitt Cancer Center.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Gastman', 'Affiliation': 'Inflammation and immunity, Cleveland Clinic.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Kovacsovics-Bankowski', 'Affiliation': 'Huntsman Cancer Institute, University of Utah.'}, {'ForeName': 'Krishna S', 'Initials': 'KS', 'LastName': 'Gunturu', 'Affiliation': 'Hematology and Oncology, Lahey Hospital and Medical Center.'}, {'ForeName': 'Scot W', 'Initials': 'SW', 'LastName': 'Ebbinghaus', 'Affiliation': 'Clinical Research/Oncology, Merck & Co., Inc.'}, {'ForeName': 'Sama', 'Initials': 'S', 'LastName': 'Ahsan', 'Affiliation': 'Clinical Research/Oncology, Merck & Co., Inc.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Oncology, Merck Research Laboratories.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Sharon', 'Affiliation': 'Cancer Therapy Evaluation Program, National Cancer Institute.'}, {'ForeName': 'Larissa A', 'Initials': 'LA', 'LastName': 'Korde', 'Affiliation': 'Cancer Therapy Evaluation Program, National Cancer Institute.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'Medicine; Division of Hematology/Oncology, University of Pittsburgh.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'Department of Medicine, Jonsson Comprehensive Cancer Center at University of California, Los Angeles, Los Angeles aribas@mednet.ucla.edu.'}]",Cancer discovery,['10.1158/2159-8290.CD-21-1141']
2890,34764183,Protective efficacy of 6-week regimen for latent tuberculosis infection treatment in rural China: 5-year follow-up of a randomised controlled trial.,"BACKGROUND


Enlarging tuberculosis (TB) preventive treatment among at-risk populations is a critical component of the End TB Strategy. It is urgently needed to develop suitable latent tuberculosis infection (LTBI) testing and treatment tools according to local TB epidemic and available resources in worldwide.
METHODS


Based on an open-labeled randomised controlled trial conducted since 2015 among rural residents aged 50-70 years with LTBI, the protective efficacy of the 6-week twice-weekly regimen of rifapentine plus isoniazid was further evaluated in a 5-year follow-up survey.
RESULTS


A total of 1298 treated participants and 1151 untreated controls were included in the 5-year protective efficacy analysis. In the per-protocol analysis, the incidence rate was 0.49/100 person-years (95% confidence interval (CI): 0.30-0.67) in the untreated control group and 0.19/100 person-years (95% CI: 0.07-0.32) in the treated group, the protection rate was 61.22%. Subgroup analysis showed that the protection rate was 76.82% in the per-protocol analysis among participants with baseline IFN-γ levels in the highest quartile (≥3.25 IU·mL -1 ). The multiple logistic regression analysis indicated that participants with baseline BMI <18.5 kg·m -2  and with pulmonary fibrotic lesions had increased hazard of developing active disease with an adjusted hazard ratio (aHR) of 3.64 (95% CI: 1.20-11.00) and 5.99 (95% CI: 2.20-16.27), respectively. In addition, individuals with higher baseline IFN-γ levels showed an increased risk of TB occurrence (aHR 2.27, 95% CI 1.13-4.58).
CONCLUSIONS


Our findings suggested the 6-week twice-weekly regimen of rifapentine plus isoniazid for LTBI treatment might be an optional tool for TB control in Chinese population.",2021,"In the per-protocol analysis, the incidence rate was 0.49/100 person-years (95% confidence interval (CI): 0.30-0.67) in the untreated control group and 0.19/100 person-years (95% CI: 0.07-0.32) in the treated group, the protection rate was 61.22%.","['2015 among rural residents aged 50-70\u2005years with LTBI', 'A total of 1298 treated participants and 1151 untreated controls', 'rural China']",['rifapentine plus isoniazid'],"['protection rate', 'Protective efficacy', 'hazard of developing active disease', 'incidence rate', 'risk of TB occurrence (aHR']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1312385', 'cui_str': 'AHR protein, human'}]",1298.0,0.564799,"In the per-protocol analysis, the incidence rate was 0.49/100 person-years (95% confidence interval (CI): 0.30-0.67) in the untreated control group and 0.19/100 person-years (95% CI: 0.07-0.32) in the treated group, the protection rate was 61.22%.","[{'ForeName': 'Henan', 'Initials': 'H', 'LastName': 'Xin', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.'}, {'ForeName': 'Xuefang', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.'}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.'}, {'ForeName': 'Boxuan', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Center for Diseases Control and Prevention of Zhongmu, Zhengzhou, China.'}, {'ForeName': 'Dakuan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Center for Diseases Control and Prevention of Zhongmu, Zhengzhou, China.'}, {'ForeName': 'Zisen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Center for Diseases Control and Prevention of Zhongmu, Zhengzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, China.""}, {'ForeName': 'Xueling', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, China.""}, {'ForeName': 'Jiaoxia', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Center for Diseases Control and Prevention of Zhongmu, Zhengzhou, China.'}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.'}, {'ForeName': 'Yongpeng', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.'}, {'ForeName': 'Zhusheng', 'Initials': 'Z', 'LastName': 'Quan', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.'}, {'ForeName': 'Shouguo', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Center for Diseases Control and Prevention of Zhongmu, Zhengzhou, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jin', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China gaolei@ipbcams.ac.cn.'}]",The European respiratory journal,['10.1183/13993003.02359-2021']
2891,34764182,"Nebulised liposomal-amphotericin-B as maintenance therapy in ABPA: a randomised, multicentre, trial.","BACKGROUND


In allergic bronchopulmonary aspergillosis (ABPA), prolonged nebulised antifungal treatment may be a strategy for maintaining remission.
METHODS


We performed a randomised, single-blind, clinical trial in 30 centres. Patients with controlled ABPA after a 4-month attack treatment (corticosteroids and itraconazole) were randomly assigned to nebulised liposomal-amphotericin-B or placebo for 6 months. The primary outcome was occurrence of a first severe clinical exacerbation within 24 months following randomisation. Secondary outcomes included the median time-to-first severe clinical exacerbation, number of severe clinical exacerbations per patient, ABPA-related biological parameters.
RESULTS


Among 174 enrolled patients with ABPA from March 2015 through July 2017, 139 were controlled after 4-month attack treatment and were randomised. The primary outcome occurred in 33 (50.8%) of 65 patients in nebulised liposomal-amphotericin-B group and 38 (51.3%) of 74 in placebo group (absolute difference -0.6%, 95% CI -16.8% to +15.6%, odds ratio 0.98, 95% CI 0.50 to 1.90; p=0.95). The median time-to-first severe clinical exacerbation was longer in liposomal-amphotericin-B group, 337 days (IQR, 168 to 476)  versus  177 (64 to 288). At the end of maintenance therapy, total immunoglobulin-E and  Aspergillus  precipitins were significantly decreased in nebulised liposomal-amphotericin-B group.
CONCLUSIONS


In ABPA, maintenance therapy using nebulised liposomal-amphotericin-B did not reduce the risk of severe clinical exacerbation. The presence of some positive secondary outcomes creates clinical equipoise for further research.",2021,"At the end of maintenance therapy, total immunoglobulin-E and  Aspergillus  precipitins were significantly decreased in nebulised liposomal-amphotericin-B group.
","['ABPA', 'allergic bronchopulmonary aspergillosis (ABPA', '174 enrolled patients with ABPA from March 2015 through July 2017, 139 were controlled after 4-month attack treatment and were randomised', 'Patients with controlled ABPA after a 4-month attack treatment (corticosteroids and', '30 centres']","['itraconazole', 'Nebulised liposomal-amphotericin-B', 'nebulised liposomal-amphotericin-B or placebo', 'nebulised liposomal-amphotericin', 'nebulised liposomal-amphotericin-B', 'liposomal-amphotericin', 'placebo', 'nebulised liposomal-amphotericin-B group']","['occurrence of a first severe clinical exacerbation', 'median time-to-first severe clinical exacerbation, number of severe clinical exacerbations per patient, ABPA-related biological parameters', 'total immunoglobulin-E and  Aspergillus  precipitins', 'risk of severe clinical exacerbation', 'median time-to-first severe clinical exacerbation']","[{'cui': 'C0004031', 'cui_str': 'Allergic bronchopulmonary aspergillosis'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C1145701', 'cui_str': 'amphotericin B liposomal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004031', 'cui_str': 'Allergic bronchopulmonary aspergillosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428539', 'cui_str': 'Total immunoglobulin measurement'}, {'cui': 'C0004034', 'cui_str': 'Aspergillus'}, {'cui': 'C0032936', 'cui_str': 'Precipitins'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",174.0,0.401976,"At the end of maintenance therapy, total immunoglobulin-E and  Aspergillus  precipitins were significantly decreased in nebulised liposomal-amphotericin-B group.
","[{'ForeName': 'Cendrine', 'Initials': 'C', 'LastName': 'Godet', 'Affiliation': 'Service de Pneumologie, Assistance Publique - Hôpitaux de Paris, Hôpital Bichat, Paris, France cendrine.godet@aphp.fr.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Université François Rabelais, Inserm, Tours, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pison', 'Affiliation': 'CHU Grenoble Alpes, Service Hospitalier Universitaire Pneumologie Physiologie, Université Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Gagnadoux', 'Affiliation': ""Département de Pneumologie, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Blanchard', 'Affiliation': 'Service des Maladies Respiratoires, Pessac, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Taillé', 'Affiliation': 'Service de Pneumologie, Groupe Hospitalier Universitaire AP-HP Nord-Université de Paris, Hôpital Bichat, et Centre de Référence constitutif des Maladies Pulmonaires Rares, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Philippe', 'Affiliation': 'Service de Pneumologie, Hôpital René Dubos, Pontoise, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Hirschi', 'Affiliation': 'Service de Pneumologie, Hôpitaux Universitaires de Strasbourg, Centre de Compétence des Maladies Pulmonaires Rares, Strasbourg, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Andréjak', 'Affiliation': 'Service de Pneumologie, CHU Amiens Picardie, Université de Picardie Jules Verne, Amiens, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourdin', 'Affiliation': 'Université de Montpellier, CHU Montpellier, PhyMedExp, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Chenivesse', 'Affiliation': ""Service de Pneumologie et Immuno-allergologie, CHU Lille, Centre de référence constitutif pour les maladies pulmonaires rares, Lille, France; University Lille, Inserm UMR9017, Institut Pasteur de Lille, CIIL - Centre d'Infection et d'Immunité de Lille, Lille, France, CRISALIS/F-CRIN INSERM network.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dominique', 'Affiliation': 'Département de Pneumologie, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Bassinet', 'Affiliation': 'Service de pneumologie, CHI de Créteil, Créteil, France.'}, {'ForeName': 'Marlène', 'Initials': 'M', 'LastName': 'Murris-Espin', 'Affiliation': 'Service de Pneumologie, CHU de Toulouse, CRCM adulte et Transplantation pulmonaire. Clinique des Voies Respiratoires, Hôpital Larrey, Toulouse, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Rivière', 'Affiliation': ""Service de Pneumologie, Hôpital d'Instruction des Armées Percy, Clamart, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Garcia', 'Affiliation': 'Université Paris-Saclay, School of Medicine, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Caillaud', 'Affiliation': 'Service de Pneumologie-Allergologie, CHU Gabriel Montpied, Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Blanc', 'Affiliation': ""Service de Pneumologie et centre d'investigations cliniques Thorax, CHU de Nantes, Nantes, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Goupil', 'Affiliation': 'Service de pneumologie, CH Le Mans, Le Mans, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bergeron', 'Affiliation': 'Service de Pneumologie, Assistance Publique - Hôpitaux de Paris, Hôpital Saint-Louis, Université de Paris, Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gondouin', 'Affiliation': 'Service de pneumologie, CHU Besançon, Besançon, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': 'CHU Poitiers, Médecine Intensive Réanimation, Poitiers, France; Inserm, CIC, Université de Poitiers, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Flament', 'Affiliation': 'service de pneumologie et explorations fonctionnelles respiratoires, CHRU de Tours, Tours, France.'}, {'ForeName': 'Boubou', 'Initials': 'B', 'LastName': 'Camara', 'Affiliation': 'CHU Grenoble Alpes, Service Hospitalier Universitaire Pneumologie Physiologie, Université Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Pascaline', 'Initials': 'P', 'LastName': 'Priou', 'Affiliation': ""Département de Pneumologie, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Brun', 'Affiliation': 'Service de Radiologie, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Laurent', 'Affiliation': 'Université de Bordeaux, Centre de Recherche Cardio-Thoracique de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': 'Faculté de Médecine et de Pharmacie de Poitiers, INSERM, CIC-1402, Biostatistics, Poitiers, France; Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'Service de Pneumologie, Assistance Publique - Hôpitaux de Paris, Hôpital Bichat, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.02218-2021']
2892,34764171,"Single-centre, double-blind, randomised, parallel-group, superiority study to evaluate the effectiveness of general anaesthesia and ultrasound-guided transversus thoracis muscle plane block combination in adult cardiac surgery for reducing the surgical stress response: clinical trial protocol.","INTRODUCTION


Adult open-heart surgery is a major surgery that causes surgical stress response and activation of the immune system, contributing further to postoperative complications. Transversus thoracis muscle plane block (TTPB) may potentially benefit in reducing the surgical stress response. This study aims to know the effectiveness of preoperative TTPB in adult open-heart surgery for reducing the surgical stress response.
METHODS AND ANALYSIS


This study is a prospective, double-blind, randomised control trial comparing the combination of general anaesthesia and TTPB versus general anaesthesia only in adult open-heart surgery. Forty-two eligible subjects will be randomly assigned to the TTPB group or control group. The primary outcomes are the difference between the two groups in the means of postoperative cortisol and interleukin-6 plasma levels at 24 hours and 48 hours after cardiac intensive care unit admission. The secondary outcomes are the difference between the two groups in the means of total 24-hour postoperative morphine consumption and time of first postoperative patient-controlled analgesia (PCA) dose.
ETHICS AND DISSEMINATION


The study protocol and informed consent forms have been reviewed and approved by the Ethics Committee of Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo Hospital. The result will be released to the medical community through presentation and publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04544254.",2021,The primary outcomes are the difference between the two groups in the means of postoperative cortisol and interleukin-6 plasma levels at 24 hours and 48 hours after cardiac intensive care unit admission.,"['adult open-heart surgery', 'Forty-two eligible subjects']","['Transversus thoracis muscle plane block (TTPB', 'general anaesthesia and TTPB', 'general anaesthesia and ultrasound-guided transversus thoracis muscle plane block combination', 'TTPB', 'preoperative TTPB']","['postoperative cortisol and interleukin-6 plasma levels', 'total 24-hour postoperative morphine consumption and time of first postoperative patient-controlled analgesia (PCA) dose.\nETHICS AND DISSEMINATION']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C4319566', 'cui_str': '42'}]","[{'cui': 'C1744608', 'cui_str': 'Structure of transverse thoracis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}]",42.0,0.414555,The primary outcomes are the difference between the two groups in the means of postoperative cortisol and interleukin-6 plasma levels at 24 hours and 48 hours after cardiac intensive care unit admission.,"[{'ForeName': 'A A Gde Putra Semara', 'Initials': 'AAGPS', 'LastName': 'Jaya', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Dr. Cipto Mangunkusumo Hospital - Faculty of Medicine Universitas Indonesia, Jakarta Pusat, Indonesia.'}, {'ForeName': 'Aida Rosita', 'Initials': 'AR', 'LastName': 'Tantri', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Dr. Cipto Mangunkusumo Hospital - Faculty of Medicine Universitas Indonesia, Jakarta Pusat, Indonesia aidatantri@yahoo.com.'}, {'ForeName': 'Aldy', 'Initials': 'A', 'LastName': 'Heriwardito', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Dr. Cipto Mangunkusumo Hospital - Faculty of Medicine Universitas Indonesia, Jakarta Pusat, Indonesia.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Mansjoer', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Dr. Cipto Mangunkusumo Hospital - Faculty of Medicine Universitas Indonesia, Jakarta Pusat, Indonesia.'}]",BMJ open,['10.1136/bmjopen-2021-051008']
2893,34764169,"CATALYST trial protocol: a multicentre, open-label, phase II, multiarm trial for an early and accelerated evaluation of the potential treatments for COVID-19 in hospitalised adults.","INTRODUCTION


Severe SARS-CoV-2 infection is associated with a dysregulated immune response. Inflammatory monocytes and macrophages are crucial, promoting injurious, proinflammatory sequelae. Immunomodulation is, therefore, an attractive therapeutic strategy and we sought to test licensed and novel candidate drugs.
METHODS AND ANALYSIS


The CATALYST trial is a multiarm, open-label, multicentre, phase II platform trial designed to identify candidate novel treatments to improve outcomes of patients hospitalised with COVID-19 compared with usual care. Treatments with evidence of biomarker improvements will be put forward for larger-scale testing by current national phase III platform trials. Hospitalised patients >16 years with a clinical picture strongly suggestive of SARS-CoV-2 pneumonia (confirmed by chest X-ray or CT scan, with or without a positive reverse transcription PCR assay) and a C reactive protein (CRP) ≥40 mg/L are eligible. The primary outcome measure is CRP, measured serially from admission to day 14, hospital discharge or death. Secondary outcomes include the WHO Clinical Progression Improvement Scale as a principal efficacy assessment.
ETHICS AND DISSEMINATION


The protocol was approved by the East Midlands-Nottingham 2 Research Ethics Committee (20/EM/0115) and given urgent public health status; initial approval was received on 5 May 2020, current protocol version (V.6.0) approval on 12 October 2020. The MHRA also approved all protocol versions. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBERS


EudraCT2020-001684-89, ISRCTN40580903.",2021,"Hospitalised patients >16 years with a clinical picture strongly suggestive of SARS-CoV-2 pneumonia (confirmed by chest X-ray or CT scan, with or without a positive reverse transcription PCR assay) and a C reactive protein (CRP) ≥40 ","['hospitalised adults', 'patients hospitalised with COVID-19 compared with usual care', 'Hospitalised patients >16 years with a clinical picture strongly suggestive of SARS-CoV-2 pneumonia (confirmed by chest X-ray or CT scan, with or without a positive reverse transcription PCR assay) and a C reactive protein (CRP) ≥40']",[],"['CRP, measured serially from admission to day 14, hospital discharge or death', 'WHO Clinical Progression Improvement Scale as a principal efficacy assessment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035380', 'cui_str': 'Transcription, Reverse'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",[],"[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.17347,"Hospitalised patients >16 years with a clinical picture strongly suggestive of SARS-CoV-2 pneumonia (confirmed by chest X-ray or CT scan, with or without a positive reverse transcription PCR assay) and a C reactive protein (CRP) ≥40 ","[{'ForeName': 'Tonny', 'Initials': 'T', 'LastName': 'Veenith', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Fisher', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK b.fisher@bham.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Slade', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rowe', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Sharpe', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thickett', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Whitehouse', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rowland', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Scriven', 'Affiliation': 'Department of Infectious Diseases, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Dhruv', 'Initials': 'D', 'LastName': 'Parekh', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Bowden', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'Oxford Clinical Trials Research Unit, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Bion', 'Affiliation': 'Department of Critical Care Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Kearns', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-050202']
2894,34446756,Relationship of subjective and objective sleep measures with physical performance in advanced-stage lung cancer patients.,"Advanced lung cancer patients suffer from deteriorated physical function, which negatively impacts physical and psychological health. As little is known about sleep and physical function in this population, this study aimed to examine the association between subjective and objective sleep parameters and physical function among them. 164 advanced lung cancer patients were included. Objective sleep was measured by actigraphy (measured on non-dominant wrist for 72 h), and subjective sleep quality was assessed by the Pittsburgh Sleep Quality Index (PSQI). Performance-based physical function was measured by Timed Up and Go Test (TUGT), 6-Minute Walk Test (6MWT), Sit-to-Stand Test, and One-leg Standing Test. Univariable and multivariable regression analyses were employed to examine the association between sleep and physical function. Total sleep time (TST) was significantly associated with the 6MWT (β = 0.259; 95% CI 0.120, 0.398; P < 0.001), TUGT (β = - 0.012; 95% CI = - 0.017, - 0.008; P < 0.001) and Sit-to-Stand Test (β = 0.027; 95% CI = 0.018, 0.035; P < 0.001) after adjustment for multiple covariates. PSQI global score was only significantly associated with TUGT (β = 0.140; 95% CI = 0.000, 0.280; P = 0.050) after adjustment for multiple covariates. Shorter sleep duration significantly predicted poorer physical performance in advanced lung cancer patients, and more attention is required for those with less than 4.3 h of sleep on average.Trial registration: ClinicalTrials.gov, NCT03482323. Registered 29 March 2018, https://clinicaltrials.gov/ct2/show/NCT03482323 ; ClinicalTrials.gov, NCT04119778. Registered 8 October 2019, https://clinicaltrials.gov/ct2/show/NCT04119778 .",2021,"Total sleep time (TST) was significantly associated with the 6MWT (β = 0.259; 95% CI 0.120, 0.398; P < 0.001), TUGT (β = - 0.012; 95% CI = - 0.017, - 0.008; P < 0.001) and Sit-to-Stand Test (β = 0.027; 95% CI = 0.018, 0.035; P < 0.001) after adjustment for multiple covariates.","['advanced-stage lung cancer patients', 'Advanced lung cancer patients', 'advanced lung cancer patients', '164 advanced lung cancer patients']",[],"['Timed Up and Go Test (TUGT), 6-Minute Walk Test (6MWT), Sit-to-Stand Test, and One-leg Standing Test', 'PSQI global score', 'Pittsburgh Sleep Quality Index (PSQI', 'subjective sleep quality', 'Total sleep time (TST', 'Performance-based physical function', 'physical performance', 'Objective sleep']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]",[],"[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.208683,"Total sleep time (TST) was significantly associated with the 6MWT (β = 0.259; 95% CI 0.120, 0.398; P < 0.001), TUGT (β = - 0.012; 95% CI = - 0.017, - 0.008; P < 0.001) and Sit-to-Stand Test (β = 0.027; 95% CI = 0.018, 0.035; P < 0.001) after adjustment for multiple covariates.","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Takemura', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 4/F, William M.W. Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Denise Shuk Ting', 'Initials': 'DST', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 4/F, William M.W. Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Daniel Yee Tak', 'Initials': 'DYT', 'LastName': 'Fong', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 4/F, William M.W. Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Anne Wing Mui', 'Initials': 'AWM', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Guangdong, China.'}, {'ForeName': 'Tai-Chung', 'Initials': 'TC', 'LastName': 'Lam', 'Affiliation': 'Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Guangdong, China.'}, {'ForeName': 'James Chung-Man', 'Initials': 'JC', 'LastName': 'Ho', 'Affiliation': 'Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Tsz Yeung', 'Initials': 'TY', 'LastName': 'Kam', 'Affiliation': 'Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong.'}, {'ForeName': 'Jeannie Yin Kwan', 'Initials': 'JYK', 'LastName': 'Chik', 'Affiliation': 'Department of Clinical Oncology, Queen Elizabeth Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Chia-Chin', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 4/F, William M.W. Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong. cclin@hku.hk.'}]",Scientific reports,['10.1038/s41598-021-96481-7']
2895,34193885,Lipidomics study of plasma from patients suggest that ALS and PLS are part of a continuum of motor neuron disorders.,"Motor neuron disorders (MND) include a group of pathologies that affect upper and/or lower motor neurons. Among them, amyotrophic lateral sclerosis (ALS) is characterized by progressive muscle weakness, with fatal outcomes only in a few years after diagnosis. On the other hand, primary lateral sclerosis (PLS), a more benign form of MND that only affects upper motor neurons, results in life-long progressive motor dysfunction. Although the outcomes are quite different, ALS and PLS present with similar symptoms at disease onset, to the degree that both disorders could be considered part of a continuum. These similarities and the lack of reliable biomarkers often result in delays in accurate diagnosis and/or treatment. In the nervous system, lipids exert a wide variety of functions, including roles in cell structure, synaptic transmission, and multiple metabolic processes. Thus, the study of the absolute and relative concentrations of a subset of lipids in human pathology can shed light into these cellular processes and unravel alterations in one or more pathways. In here, we report the lipid composition of longitudinal plasma samples from ALS and PLS patients initially, and after 2 years following enrollment in a clinical study. Our analysis revealed common aspects of these pathologies suggesting that, from the lipidomics point of view, PLS and ALS behave as part of a continuum of motor neuron disorders.",2021,"Although the outcomes are quite different, ALS and PLS present with similar symptoms at disease onset, to the degree that both disorders could be considered part of a continuum.",[],[],[],[],[],[],,0.0583604,"Although the outcomes are quite different, ALS and PLS present with similar symptoms at disease onset, to the degree that both disorders could be considered part of a continuum.","[{'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Area-Gomez', 'Affiliation': 'Departments of Neurology, Columbia University Medical Center, Room P&S 4-443, 630 West 168th Street, New York, NY, 10032, USA. eag2118@columbia.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Larrea', 'Affiliation': 'Departments of Neurology, Columbia University Medical Center, Room P&S 4-443, 630 West 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yun', 'Affiliation': 'Departments of Neurology, Columbia University Medical Center, Room P&S 4-443, 630 West 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Pathology and Cell Biology, Columbia University Medical Center, New York, NY, 10032, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hupf', 'Affiliation': 'Departments of Neurology, Columbia University Medical Center, Room P&S 4-443, 630 West 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zandkarimi', 'Affiliation': 'Biological Sciences, Columbia University Medical Center, New York, NY, 10032, USA.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Chan', 'Affiliation': 'Pathology and Cell Biology, Columbia University Medical Center, New York, NY, 10032, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mitsumoto', 'Affiliation': 'Departments of Neurology, Columbia University Medical Center, Room P&S 4-443, 630 West 168th Street, New York, NY, 10032, USA.'}]",Scientific reports,['10.1038/s41598-021-92112-3']
2896,34465809,Kallistatin limits abdominal aortic aneurysm by attenuating generation of reactive oxygen species and apoptosis.,"Inflammation, vascular smooth muscle cell apoptosis and oxidative stress are believed to play important roles in abdominal aortic aneurysm (AAA) pathogenesis. Human kallistatin (KAL; gene SERPINA4) is a serine proteinase inhibitor previously shown to inhibit inflammation, apoptosis and oxidative stress. The aim of this study was to investigate the role of KAL in AAA through studies in experimental mouse models and patients. Serum KAL concentration was negatively associated with the diagnosis and growth of human AAA. Transgenic overexpression of the human KAL gene (KS-Tg) or administration of recombinant human KAL (rhKAL) inhibited AAA in the calcium phosphate (CaPO 4 ) and subcutaneous angiotensin II (AngII) infusion mouse models. Upregulation of KAL in both models resulted in reduction in the severity of aortic elastin degradation, reduced markers of oxidative stress and less vascular smooth muscle apoptosis within the aorta. Administration of rhKAL to vascular smooth muscle cells incubated in the presence of AngII or in human AAA thrombus-conditioned media reduced apoptosis and downregulated markers of oxidative stress. These effects of KAL were associated with upregulation of Sirtuin 1 activity within the aortas of both KS-Tg mice and rodents receiving rhKAL. These results suggest KAL-Sirtuin 1 signalling limits aortic wall remodelling and aneurysm development through reductions in oxidative stress and vascular smooth muscle cell apoptosis. Upregulating KAL may be a novel therapeutic strategy for AAA.",2021,"Upregulation of KAL in both models resulted in reduction in the severity of aortic elastin degradation, reduced markers of oxidative stress and less vascular smooth muscle apoptosis within the aorta.",[],"['recombinant human KAL (rhKAL) inhibited AAA', 'KAL']","['oxidative stress', 'Serum KAL concentration']",[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0076727', 'cui_str': 'kallistatin'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0076727', 'cui_str': 'kallistatin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.173384,"Upregulation of KAL in both models resulted in reduction in the severity of aortic elastin degradation, reduced markers of oxidative stress and less vascular smooth muscle apoptosis within the aorta.","[{'ForeName': 'Smriti Murali', 'Initials': 'SM', 'LastName': 'Krishna', 'Affiliation': 'The Vascular Biology Unit, Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.'}, {'ForeName': 'Jiaze', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Vascular Biology Unit, Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.'}, {'ForeName': 'Yutang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Vascular Biology Unit, Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.'}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Moran', 'Affiliation': 'The Vascular Biology Unit, Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Trollope', 'Affiliation': 'The Vascular Biology Unit, Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.'}, {'ForeName': 'Pacific', 'Initials': 'P', 'LastName': 'Huynh', 'Affiliation': 'The Vascular Biology Unit, Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.'}, {'ForeName': 'Roby', 'Initials': 'R', 'LastName': 'Jose', 'Affiliation': 'The Vascular Biology Unit, Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Biros', 'Affiliation': 'The Vascular Biology Unit, Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Physiology, Health Sciences Centre, University of Oklahoma, Oklahoma City, OK, 73104, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Golledge', 'Affiliation': 'The Vascular Biology Unit, Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia. jonathan.golledge@jcu.edu.au.'}]",Scientific reports,['10.1038/s41598-021-97042-8']
2897,34708432,Utility of phrenic nerve conduction studies for identification of patients with neuromuscular diseases requiring invasive mechanical ventilation.,"INTRODUCTION/AIMS


Predicting when a patient will require invasive mechanical ventilation (IMV) is a major challenge in routine care for some neuromuscular diseases. In this study, we prospectively investigated whether phrenic nerve conduction studies (PNCS) can predict when IMV will be required in patients with amyotrophic lateral sclerosis (ALS), Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and myotonic dystrophy (DM).
METHODS


PNCS amplitude (avAMP) and latency (avLAT) were compared between patients who required IMV (IMV group) and those who did not (non-IMV group). PNCS were performed in 62 healthy controls and in patients with four different diseases that may require IMV: ALS (n = 56), GBS (n = 72), CIDP (n = 38), and DM (n = 24).
RESULTS


The IMV group consisted of 12 patients with ALS, 14 with GBS, 2 with CIDP, and 4 with DM. avAMP was significantly lower in the IMV group with ALS than in the non-IMV group (P < .05), but no significant difference was observed in avLAT. avAMP was significantly lower and avLAT was significantly longer in the IMV group with GBS than in the non-IMV group (both P < .05). Receiver operating characteristic analysis showed that the avAMP cutoff between the IMV and non-IMV groups was 184.3 μV (area under the curve = 0.921; sensitivity, 84.6%; specificity, 88.2%) for ALS and GBS.
DISCUSSION


PNCSs may aid in determining whether a patient with ALS or GBS requires IMV.",2021,avAMP was significantly lower and avLAT was significantly longer in the IMV group with GBS than in the non-IMV group (both P < .05).,"['62 healthy controls and in patients with four different diseases that may require IMV: ALS (n\xa0=\xa056), GBS (n\xa0=\xa072), CIDP', 'patients with amyotrophic lateral sclerosis (ALS), Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and myotonic dystrophy (DM', 'patients who required IMV (IMV group) and those who did not (non-IMV group', 'patients with neuromuscular diseases requiring invasive mechanical ventilation']","['phrenic nerve conduction studies', 'phrenic nerve conduction studies (PNCS', 'PNCS']","['avAMP', 'avLAT', 'PNCS amplitude (avAMP) and latency (avLAT']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0018378', 'cui_str': 'Guillain-Barré syndrome'}, {'cui': 'C0393819', 'cui_str': 'Chronic inflammatory demyelinating polyradiculoneuropathy'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}, {'cui': 'C0027126', 'cui_str': 'Steinert myotonic dystrophy syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}]","[{'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0646690', 'cui_str': 'avidin-adenosine monophosphate conjugate'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",12.0,0.0369015,avAMP was significantly lower and avLAT was significantly longer in the IMV group with GBS than in the non-IMV group (both P < .05).,"[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Narukawa', 'Affiliation': 'Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Ishizuka', 'Affiliation': 'Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Kyoichi', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.'}]",Muscle & nerve,['10.1002/mus.27449']
2898,34748393,Colchicine in Patients With Acute Coronary Syndrome: Two-Year Follow-Up of the Australian COPS Randomized Clinical Trial.,,2021,,['Patients With Acute Coronary Syndrome'],['Colchicine'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}]",[],,0.264501,,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Tong', 'Affiliation': ""St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia (D.C.T., R.W., J.L.).""}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Bloom', 'Affiliation': 'Cardiology, Department of Medicine, Peninsula Health, Frankston, Victoria, Australia (D.C.T., J.E.B., R.S., N.M.H., A. Yeap, B.Y., S.W., P.P., M.P., J.L.).'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Quinn', 'Affiliation': 'Swinburne University of Technology, Department of Health Science and Biostatistics, Hawthorn, Victoria, Australia (S.Q.).'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Nasis', 'Affiliation': 'MonashHeart, Monash Health, Clayton, Victoria, Australia (A.N.).'}, {'ForeName': 'Chin', 'Initials': 'C', 'LastName': 'Hiew', 'Affiliation': 'Barwon Health - University Hospital Geelong, Victoria, Australia (C.H., J.A.).'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Roberts-Thomson', 'Affiliation': 'Royal Hobart Hospital, Hobart, Tasmania, Australia (P.R.-T., H.A.).'}, {'ForeName': 'Heath', 'Initials': 'H', 'LastName': 'Adams', 'Affiliation': 'Royal Hobart Hospital, Hobart, Tasmania, Australia (P.R.-T., H.A.).'}, {'ForeName': 'Rumes', 'Initials': 'R', 'LastName': 'Sriamareswaran', 'Affiliation': 'Cardiology, Department of Medicine, Peninsula Health, Frankston, Victoria, Australia (D.C.T., J.E.B., R.S., N.M.H., A. Yeap, B.Y., S.W., P.P., M.P., J.L.).'}, {'ForeName': 'Nay M', 'Initials': 'NM', 'LastName': 'Htun', 'Affiliation': 'Cardiology, Department of Medicine, Peninsula Health, Frankston, Victoria, Australia (D.C.T., J.E.B., R.S., N.M.H., A. Yeap, B.Y., S.W., P.P., M.P., J.L.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wilson', 'Affiliation': 'Royal Melbourne Hospital, Parkville, Victoria, Australia (W.W.).'}, {'ForeName': 'Dion', 'Initials': 'D', 'LastName': 'Stub', 'Affiliation': 'Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia (J.E.B., D.S.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'van Gaal', 'Affiliation': 'Northern Health, Epping, Victoria, Australia (W.v.G.).'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Howes', 'Affiliation': 'Gold Coast University Hospital, Southport, Queensland, Australia (L.H.).'}, {'ForeName': 'Allysha', 'Initials': 'A', 'LastName': 'Yeap', 'Affiliation': 'Cardiology, Department of Medicine, Peninsula Health, Frankston, Victoria, Australia (D.C.T., J.E.B., R.S., N.M.H., A. Yeap, B.Y., S.W., P.P., M.P., J.L.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Yip', 'Affiliation': 'Cardiology, Department of Medicine, Peninsula Health, Frankston, Victoria, Australia (D.C.T., J.E.B., R.S., N.M.H., A. Yeap, B.Y., S.W., P.P., M.P., J.L.).'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Cardiology, Department of Medicine, Peninsula Health, Frankston, Victoria, Australia (D.C.T., J.E.B., R.S., N.M.H., A. Yeap, B.Y., S.W., P.P., M.P., J.L.).'}, {'ForeName': 'Padeepa', 'Initials': 'P', 'LastName': 'Perera', 'Affiliation': 'Cardiology, Department of Medicine, Peninsula Health, Frankston, Victoria, Australia (D.C.T., J.E.B., R.S., N.M.H., A. Yeap, B.Y., S.W., P.P., M.P., J.L.).'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Collins', 'Affiliation': 'John Hunter Hospital, New Lambton Heights, New South Wales, Australia (N.C.).'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Yong', 'Affiliation': 'Concord Repatriation General Hospital, New South Wales, Australia (A. Yong).'}, {'ForeName': 'Ravinay', 'Initials': 'R', 'LastName': 'Bhindi', 'Affiliation': 'Royal North Shore Hospital, St Leonards, New South Wales, Australia (R.B.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Whitbourn', 'Affiliation': ""St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia (D.C.T., R.W., J.L.).""}, {'ForeName': 'Astin', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Wollongong Hospital, New South Wales, Australia (A.L.).'}, {'ForeName': 'Manuja', 'Initials': 'M', 'LastName': 'Premaratne', 'Affiliation': 'Cardiology, Department of Medicine, Peninsula Health, Frankston, Victoria, Australia (D.C.T., J.E.B., R.S., N.M.H., A. Yeap, B.Y., S.W., P.P., M.P., J.L.).'}, {'ForeName': 'Kaleab', 'Initials': 'K', 'LastName': 'Asrress', 'Affiliation': 'Bankstown-Lidcombe Hospital, New South Wales, Australia (K.A.).'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Freeman', 'Affiliation': '.EasternHealth, Box Hill, Victoria, Australia (M.F.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Amerena', 'Affiliation': 'Barwon Health - University Hospital Geelong, Victoria, Australia (C.H., J.A.).'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Layland', 'Affiliation': ""St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia (D.C.T., R.W., J.L.).""}]",Circulation,['10.1161/CIRCULATIONAHA.121.054610']
2899,34748376,Long-Term Follow-up of the Italian Flexible Sigmoidoscopy Screening Trial.,"BACKGROUND


Recent reports showed that the protective effect of flexible sigmoidoscopy (FS) screening was maintained up to17 years, although differences were reported by sex.
OBJECTIVE


To assess long-term reduction of colorectal cancer (CRC) incidence and mortality after a single FS screening.
DESIGN


Parallel randomized controlled trial. (ISRCTN registry number: 27814061).
SETTING


6 centers in Italy.
PARTICIPANTS


Persons aged 55 to 64 years expressing interest in having FS screening if invited, recruited from 1995 to 1999 and followed until 2012 (incidence) and 2014 to 2016 (mortality).
INTERVENTION


Eligible persons were randomly assigned (1:1 ratio) to either the once-only FS screening group or control (usual care) group.
MEASUREMENTS


Incidence and mortality rate ratios (RRs) and rate differences.
RESULTS


A total of 34 272 persons (17 136 in each group) were included in the analysis; 9911 participants had screening in the intervention group. Median follow-up was 15.4 years for incidence and 18.8 years for mortality. Incidence of CRC was reduced by 19% (RR, 0.81 [95% CI, 0.71 to 0.93]) in the intention-to-treat (ITT) analysis, comparing the intervention with the control group, and by 33% (RR, 0.67 [CI, 0.56 to 0.81]) in the per protocol (PP) analysis, comparing participants screened in the intervention group with the control persons. Colorectal cancer mortality was reduced by 22% (RR, 0.78 [CI, 0.61 to 0.98]) in the ITT analysis and by 39% (RR, 0.61 [CI, 0.44 to 0.84]) in the PP analysis. Incidence of CRC was statistically significantly reduced among both men and women. Colorectal cancer mortality was statistically significantly reduced among men (ITT RR, 0.73 [CI, 0.54 to 0.97]) but not among women (ITT RR, 0.90 [CI, 0.59 to 1.37]).
LIMITATION


Self-selection of volunteers from the general population sample targeted for recruitment may limit generalizability.
CONCLUSION


The strong protective effect of a single FS screening for CRC incidence and mortality was maintained up to 15 and 19 years, respectively.
PRIMARY FUNDING SOURCE


Italian Association for Cancer Research, Italian National Research Council, Istituto Oncologico Romagnolo, Fondo ""E. Tempia,"" University of Milan, and Local Health Unit ASL-Torino.",2021,"Colorectal cancer mortality was reduced by 22% (RR, 0.78","['A total of 34\xa0272 persons (17\xa0136 in each group) were included in the analysis; 9911 participants had screening in the intervention group', 'Persons aged 55 to 64 years expressing interest in having FS screening if invited, recruited from 1995 to 1999 and followed until 2012 (incidence) and 2014 to 2016 (mortality', '6 centers in Italy']","['FS screening group or control (usual care) group', 'flexible sigmoidoscopy (FS) screening', 'single FS screening']","['Colorectal cancer mortality', 'CRC incidence and mortality', 'Incidence and mortality rate ratios (RRs) and rate differences', 'colorectal cancer (CRC) incidence and mortality', 'Incidence of CRC']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.222934,"Colorectal cancer mortality was reduced by 22% (RR, 0.78","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Senore', 'Affiliation': 'University Hospital Città della Salute e della Scienza, Turin, Italy (C.S., E.R., P.A., N.S.).'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Riggi', 'Affiliation': 'University Hospital Città della Salute e della Scienza, Turin, Italy (C.S., E.R., P.A., N.S.).'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Armaroli', 'Affiliation': 'University Hospital Città della Salute e della Scienza, Turin, Italy (C.S., E.R., P.A., N.S.).'}, {'ForeName': 'Luigina', 'Initials': 'L', 'LastName': 'Bonelli', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, Genoa, Italy (L.B., S.S., C.C.).'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Sciallero', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, Genoa, Italy (L.B., S.S., C.C.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zappa', 'Affiliation': 'ISPRO, Florence, Italy (M.Z., C.B.V.).'}, {'ForeName': 'Arrigo', 'Initials': 'A', 'LastName': 'Arrigoni', 'Affiliation': 'FPO-IRCCS Candiolo Cancer Institute,Turin, Italy (A.A.).'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Casella', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, Genoa, Italy (L.B., S.S., C.C.).'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Crosta', 'Affiliation': 'IRCCS European Institute of Oncology, Milan, Italy (C.C.).'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Falcini', 'Affiliation': 'Romagna Cancer Registry, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori,"" Meldola, Forlì, Italy (F.F., O.G.).'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Ferrero', 'Affiliation': 'Infermi Hospital, Biella, Italy (F.F.).'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Fracchia', 'Affiliation': 'Mauriziano Umberto I Hospital, Turin, Italy (M.F.).'}, {'ForeName': 'Orietta', 'Initials': 'O', 'LastName': 'Giuliani', 'Affiliation': 'Romagna Cancer Registry, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori,"" Meldola, Forlì, Italy (F.F., O.G.).'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Risio', 'Affiliation': 'FPO-IRCCS Candiolo Cancer Institute, Turin, Italy (M.R.).'}, {'ForeName': 'Antonio G', 'Initials': 'AG', 'LastName': 'Russo', 'Affiliation': 'Agency for Health Protection of the Metropolitan Area of Milan, Milan, Italy (A.G.R.).'}, {'ForeName': 'Carmen Beatriz', 'Initials': 'CB', 'LastName': 'Visioli', 'Affiliation': 'ISPRO, Florence, Italy (M.Z., C.B.V.).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Rosso', 'Affiliation': 'Piedmont Cancer Registry, University Hospital Città della Salute e della Scienza, Turin, Italy (S.R.).'}, {'ForeName': 'Nereo', 'Initials': 'N', 'LastName': 'Segnan', 'Affiliation': 'University Hospital Città della Salute e della Scienza, Turin, Italy (C.S., E.R., P.A., N.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M21-0977']
2900,34748653,Crown Accuracy and Time Efficiency of Cement-Retained Implant-Supported Restorations in a Complete Digital Workflow: A Randomized Control Trial.,"PURPOSE


This is a clinical study to compare complete digital workflows generated using intraoral scanning and the split-file technique with a conventional workflow for cement-retained implant-supported restorations.
MATERIALS AND METHODS


Forty patients requiring posterior single-unit implant restorations were included. Twenty patients were randomly assigned to the complete digital workflow group, involving intraoral scanning and manufacture of cement-retained crowns using the split-file technique (test group). The remaining 20 patients were assigned to the hybrid workflow group (control group), involving conventional impressions and CAD/CAM-fabricated crowns based on stone casts. Scanning of the crowns was performed before and after clinical adjustment using an intraoral scanner (TRIOS Color; 3Shape). Two 3D digital models were trimmed and superimposed to evaluate changes in dimensions using Geomagic Control 2014 software. Chair-side and laboratory times for the entire workflow were recorded. Independent-sample t tests were used for the statistical analysis.
RESULTS


All crowns were inserted without re-fabrication. The average maximum occlusal adjustment of the crowns, measured as maximum deviation of occlusal area in superimposed pre and post scans, was -212.7 ±150.5 and -330.7 ±192.5 μm in the test and control groups, respectively (p = 0.037).The average area of occlusal adjustment, measured as area of deviation larger than 100 μm, was 8.4 ±8.1 and 17.1 ±12.3 mm 2  in the test and control groups, respectively (p = 0.012). The mesial and distal contact adjustment amounts, maximum deviations of proximal area, were -33.0 ±96.2 and -48.6 ±70.5 μm in the test group, and -3.7 ±66.7 μm and -11.4 ±106.7 μm in the control group, respectively. The mean chair-side time was 20.20 ± 3.00 and 26.65 ± 4.53 min in the test and control groups, respectively (p < 0.001). The mean laboratory time was 43.70 ± 5.56 and 84.55 ± 5.81 min in the test and control groups, respectively (p < 0.001).
CONCLUSIONS


Single-unit cement-retained crowns with complete digital workflows required fewer crown adjustments and had shorter clinical and laboratory times compared to conventional impressions and hybrid workflows. Digital impressions and the split-file technique provided customized abutments and cement-retained crowns, thus broadening the indications for digital workflows for implants. This article is protected by copyright. All rights reserved.",2021,"CONCLUSIONS


Single-unit cement-retained crowns with complete digital workflows required fewer crown adjustments and had shorter clinical and laboratory times compared to conventional impressions and hybrid workflows.","['a Complete Digital Workflow', 'Forty patients requiring posterior single-unit implant restorations were included', 'Twenty patients']","['Cement-Retained Implant-Supported Restorations', 'hybrid workflow group (control group), involving conventional impressions and CAD/CAM-fabricated crowns based on stone casts', 'complete digital workflow group, involving intraoral scanning and manufacture of cement-retained crowns using the split-file technique']","['mean chair-side time', 'mesial and distal contact adjustment amounts, maximum deviations of proximal area', 'mean laboratory time', 'maximum deviation of occlusal area']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}]",20.0,0.118068,"CONCLUSIONS


Single-unit cement-retained crowns with complete digital workflows required fewer crown adjustments and had shorter clinical and laboratory times compared to conventional impressions and hybrid workflows.","[{'ForeName': 'Shuxin', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Xie', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Di', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, China.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13447']
2901,34748649,Intolerance of uncertainty and novelty facilitated extinction: The impact of reinforcement schedule.,"Individuals who score high in intolerance of uncertainty (IU) display reduced threat extinction. Recently, it was shown that replacing threat associations with novel associations during extinction learning (i.e., presenting a novel tone 100% of the time) can promote threat extinction retention in individuals with high IU. This novelty facilitated extinction (NFE) effect could be driven by the tone's novelty or reliability. Here, we sought to address this question by adjusting the reliability of the novel tone (i.e., the reinforcement rate) during NFE. We measured skin conductance response during an associative learning task in which participants (n = 92) were assigned to one of three experimental groups: standard extinction, NFE 100% reinforcement, or NFE 50% reinforcement. For standard extinction, compared to NFE 100% and 50% reinforcement groups, we observed a trend for greater recovery of the conditioned response during extinction retention. Individuals with high IU relative to low IU in the standard extinction group demonstrated a larger recovery of the conditioned response during extinction retention. These findings tentatively suggest that NFE effects are driven by the novelty rather than the reliability of the new stimulus. The implications of these findings for translational and clinical research in anxiety disorder pathology are discussed.",2021,Individuals with high IU relative to low IU in the standard extinction group demonstrated a larger recovery of the conditioned response during extinction retention.,"['individuals with high IU', 'participants (n\xa0=\xa092', 'Individuals who score high in intolerance of uncertainty (IU) display reduced threat extinction']","['standard extinction, NFE 100% reinforcement, or NFE 50% reinforcement', 'associative learning task']","['Intolerance of uncertainty and novelty facilitated extinction', 'skin conductance response']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0009649', 'cui_str': 'Conditioning, Classical'}]","[{'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",92.0,0.089388,Individuals with high IU relative to low IU in the standard extinction group demonstrated a larger recovery of the conditioned response during extinction retention.,"[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wake', 'Affiliation': 'Centre for Integrative Neuroscience and Neurodynamics, School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dodd', 'Affiliation': 'Centre for Integrative Neuroscience and Neurodynamics, School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Morriss', 'Affiliation': 'Centre for Integrative Neuroscience and Neurodynamics, School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}]","British journal of psychology (London, England : 1953)",['10.1111/bjop.12538']
2902,34748565,Long-term foot outcomes following differential abatement of inflammation and osteoclastogenesis for active Charcot neuroarthropathy in diabetes mellitus.,"AIMS


Inflammatory osteolysis is sine-qua-non of active Charcot neuroarthropathy (CN) causing decreased foot bone mineral density (BMD) and fractures. We aimed to explore the effect of anti-inflammatory or anti-resorptive agents for effect on foot bone mineral content (BMC) and consequent long-term outcomes of foot deformities, fractures and amputation.
METHODS


Forty-three patients with active CN (temperature difference >2°C from normal foot) were evaluated. Patients were off-loaded with total contact cast and randomized to receive either methylprednisolone (1gm) (group A), zoledronate (5mg) (group B) or placebo (100ml normal saline) (group C) once monthly infusion for three consecutive months. Change in foot BMC was assessed at 6 months or at remission and followed subsequently up to 4 years for the incidence of new-onset fracture, deformities, or CN recurrence.
RESULTS


Thirty-six participants (24 male, 12 female) were randomized (11 in group A, 12 group B, 13 group C). The mean age was 57.7± 9.9 years, duration of diabetes 12.3± 5.8 years and symptom duration 6.5± 2.8 weeks. BMC increased by 36% with zoledronate (p = 0.02) but reduced by 13% with methylprednisolone (p = 0.03) and 9% (p = 0.09) with placebo at remission. There were no incident foot fractures, however, two patients sustained ulcers, and 3 had new-onset or worsening deformities and none required amputation during 3.36 ± 0.89 years of follow-up.
CONCLUSION


Bisphosphonate for active CN is associated with an increase in foot bone mineral content as compared to decrease with steroids or total contact cast but long-term outcomes of foot deformities, ulceration and amputation are similar.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03289338.",2021,BMC increased by 36% with zoledronate (p = 0.02) but reduced by 13% with methylprednisolone (p = 0.03) and 9% (p = 0.09) with placebo at remission.,"['Thirty-six participants (24 male, 12 female', 'Forty-three patients with active CN (temperature difference >2°C from normal foot', 'diabetes mellitus', 'The mean age was 57.7± 9.9 years, duration of diabetes 12.3± 5.8 years and symptom duration 6.5± 2.8 weeks']","['zoledronate', 'methylprednisolone', 'Bisphosphonate', 'anti-inflammatory or anti-resorptive agents', 'placebo (100ml normal saline', 'placebo']","['foot bone mineral density (BMD) and fractures', 'foot bone mineral content', 'Change in foot BMC', 'foot bone mineral content (BMC', 'new-onset or worsening deformities', 'BMC']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0576239', 'cui_str': 'Foot normal'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0016505', 'cui_str': 'Bone structure of foot'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",43.0,0.0374532,BMC increased by 36% with zoledronate (p = 0.02) but reduced by 13% with methylprednisolone (p = 0.03) and 9% (p = 0.09) with placebo at remission.,"[{'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Das', 'Affiliation': 'Department of Endocrinology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Endocrinology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Jude', 'Affiliation': 'Tameside and Glossop Integrated Care NHS Foundation Trust, Ashton on Lyne, United Kingdom.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Prakash', 'Affiliation': 'Department of Radiodiagnosis, PGIMER, Chandigarh, India.'}, {'ForeName': 'Pinaki', 'Initials': 'P', 'LastName': 'Dutta', 'Affiliation': 'Department of Endocrinology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Bhansali', 'Affiliation': 'Department of Endocrinology, PGIMER, Chandigarh, India.'}]",PloS one,['10.1371/journal.pone.0259224']
2903,34748549,The added value of cognition-targeted exercise versus symptom-targeted exercise for multiple sclerosis fatigue: A randomized controlled pilot trial.,"BACKGROUND


Fatigue is considered one of the most common symptoms of multiple sclerosis (MS) and lacks a current standardized treatment. Therefore, the aim of this study was to examine the feasibility and effectiveness of a cognition-targeted exercise versus symptom-targeted exercise for MS fatigue.
METHODS


In this Pilot, parallel-group, randomized controlled trial, sixty participants with multiple sclerosis, were randomly assigned to either a Cognition-Targeted Exercise (CTE) (N = 30, mean age 41) or a Symptom-Targeted Exercise (STE) (N = 30, mean age 42). The participants in the experimental group received eight, 50-minute sessions of weekly Cognitive Behavior Therapy (CBT) in addition to a CTE Program; whereas, participants in the control group received eight, 50-minute sessions of weekly CBT in addition to the standardized physiotherapy program (STE Program). Feasibility was assessed through recruitment rate, participant retention, adherence and safety, in addition to clinical outcome measures, including: (1) Modified Fatigue Impact Scale (MFIS), (2) Work and Social Adjustment Scale (WSAS), (3) Hospital Anxiety and Depression Scale (HADS), and Perceived Stress Scale (PSS). All outcome measures were assessed at baseline (pretreatment), following completion of the eight visit intervention protocol, and at 3-months follow-up.
RESULTS


The recruitment rate was 60% and 93% of participants completed the entire study. The recruited participants complied with 98% of the required visits. No adverse events were recorded. A Generalized Estimation Equation Model revealed a significant difference over time as an interaction term during the post and follow up visit for all clinical outcome measures (p < .001).
CONCLUSION


The addition of CTE to CBT exhibited positive and more lasting influence on MS fatigue outcomes compared to Symptom-Targeted Exercise (STE). Feasibility and efficacy data from this pilot study provide support for a full-scale RCT of CTE as an integral component of Multiple Sclerosis fatigue management.",2021,The addition of CTE to CBT exhibited positive and more lasting influence on MS fatigue outcomes compared to Symptom-Targeted Exercise (STE).,"['sixty participants with multiple sclerosis', 'multiple sclerosis fatigue']","['CBT in addition to the standardized physiotherapy program (STE Program', 'CTE', 'Symptom-Targeted Exercise (STE', 'cognition-targeted exercise versus symptom-targeted exercise', 'Cognitive Behavior Therapy (CBT', 'Cognition-Targeted Exercise (CTE']","['MS fatigue outcomes', 'adverse events', 'recruitment rate, participant retention, adherence and safety, in addition to clinical outcome measures, including: (1) Modified Fatigue Impact Scale (MFIS), (2) Work and Social Adjustment Scale (WSAS), (3) Hospital Anxiety and Depression Scale (HADS), and Perceived Stress Scale (PSS']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}]",60.0,0.128134,The addition of CTE to CBT exhibited positive and more lasting influence on MS fatigue outcomes compared to Symptom-Targeted Exercise (STE).,"[{'ForeName': 'Azza', 'Initials': 'A', 'LastName': 'Alketbi', 'Affiliation': 'Department of Physiotherapy, College of Health Sciences, University of Sharjah, Sharjah, United Arab Emirates.'}, {'ForeName': 'Salah', 'Initials': 'S', 'LastName': 'Basit', 'Affiliation': 'Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Nouran', 'Initials': 'N', 'LastName': 'Hamza', 'Affiliation': 'Biostatistician at Medical Agency for Research and Statistics (MARS), Egypt.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Walton', 'Affiliation': 'Department of Physical Therapy, University of Scranton, Scranton, Pennsylvania, United States of America.'}, {'ForeName': 'Ibrahim M', 'Initials': 'IM', 'LastName': 'Moustafa', 'Affiliation': 'Department of Physiotherapy, College of Health Sciences, University of Sharjah, Sharjah, United Arab Emirates.'}]",PloS one,['10.1371/journal.pone.0258752']
2904,34748516,Correction: Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial.,[This corrects the article DOI: 10.2196/29495.].,2021,[This corrects the article DOI: 10.2196/29495.].,[],['Correction: Text Messaging Versus Email Messaging to Support Patients'],[],[],"[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],,0.0521807,[This corrects the article DOI: 10.2196/29495.].,"[{'ForeName': 'Medard Kofi', 'Initials': 'MK', 'LastName': 'Adu', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Reham', 'Initials': 'R', 'LastName': 'Shalaby', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ejemai', 'Initials': 'E', 'LastName': 'Eboreime', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Adegboyega', 'Initials': 'A', 'LastName': 'Sapara', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Nnamdi', 'Initials': 'N', 'LastName': 'Nkire', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Chawla', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Chidi', 'Initials': 'C', 'LastName': 'Chima', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Achor', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Osiogo', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chue', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Greenshaw', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Vincent Israel', 'Initials': 'VI', 'LastName': 'Agyapong', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}]",JMIR research protocols,['10.2196/34515']
2905,34748469,Feasibility and Acceptability of a Classroom-based Active Breaks Intervention for 8-12-Year Old Children.,"PURPOSE


This study explored the feasibility of conducting a classroom-based active breaks intervention on sedentary behavior (SB), physical activity (PA) and attention in 8-12-year-old children.
METHODS


Eight schools were randomized on a 1:1 basis to the control or intervention. Teachers selected 10 cards detailing an activity break at random. Children then undertook each of the ten activity breaks for 30 s, three times per day for 6 weeks. School and participant recruitment, attrition rates, percentage of outcome measures collected, and acceptability were used to explore the feasibility of the study. Mixed effects models were undertaken to examine intervention effects upon measures of PA, SB and attention.
RESULTS


Two hundred and thirty-nine consent forms were issued and 153 were returned (64%). Of the 153 consents, 146 children (95%) were measured at baseline, and 117 participated in the follow-up measures (80%) 6 weeks later suggesting the intervention was acceptable for the participants. From teacher interviews, it was noted that the intervention was feasible to implement, and teachers observed positive classroom behavior changes in children. Inclusion rates for outcome measures ranged from 49% to 66%. Significant, intervention effects were observed for sitting time (B = -27.19; 95%CI: -36.84, -17.17), standing time (B = 23.51; 95%CI 14.1, 32.45) and the number of sit to stand transitions (B = 16.1; 95%CI 4.7, 26.79).
CONCLUSION


Findings suggest that it was feasible and acceptable to implement an active breaks intervention within the classroom setting. Future work should consider the effectiveness of implementing this intervention across a full academic year.",2021,"Significant, intervention effects were observed for sitting time (B = -27.19; 95%CI: -36.84, -17.17), standing time (B = 23.51; 95%CI 14.1, 32.45) and the number of sit to stand transitions (B = 16.1; 95%CI 4.7, 26.79).
","['8-12-Year Old Children', 'Eight schools', 'Two hundred and thirty-nine consent forms were issued and 153 were returned (64', '8-12-year-old children']","['classroom-based active breaks intervention', 'Classroom-based Active Breaks Intervention']","['Feasibility and Acceptability', 'sitting time', 'standing time', 'sedentary behavior (SB), physical activity (PA) and attention', 'PA, SB and attention', 'number of sit to stand transitions']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}]",8.0,0.0735558,"Significant, intervention effects were observed for sitting time (B = -27.19; 95%CI: -36.84, -17.17), standing time (B = 23.51; 95%CI 14.1, 32.45) and the number of sit to stand transitions (B = 16.1; 95%CI 4.7, 26.79).
","[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'McLellan', 'Affiliation': 'The University of the West of Scotland, Lanarkshire Campus.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Arthur', 'Affiliation': 'The University of the West of Scotland, Lanarkshire Campus.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Donnelly', 'Affiliation': 'The University of the West of Scotland, Lanarkshire Campus.'}, {'ForeName': 'Andisheh', 'Initials': 'A', 'LastName': 'Bakshi', 'Affiliation': 'University of the West of Scotland.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Fairclough', 'Affiliation': 'Edge Hill University.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Taylor', 'Affiliation': 'Leeds Trinity University.'}, {'ForeName': 'Duncan S', 'Initials': 'DS', 'LastName': 'Buchan', 'Affiliation': 'The University of the West of Scotland, Lanarkshire Campus.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2021.1923627']
2906,34748694,Feasibility of Using Daily Home High-Flow Nasal Therapy in COPD Patients Following a Recent COPD Hospitalization.,"Rationale


High-flow nasal therapy (HFNT) has beneficial effects in patients hospitalized with acute hypoxemic respiratory failure. HFNT has not been extensively studied following hospitalization for an Acute Exacerbation of COPD (AECOPD).
Objective


We explored the feasibility of conducting a multicentered trial to evaluate the use of HFNT to increase the time to next moderate/ severe exacerbation in patients recently hospitalized for a COPD exacerbation. In this pilot study we measured the hours of home daily HFNT use, maximally tolerated flow rates and temperature, and side effects for a period of 90 days.
Methods


Patients were enrolled in a 90-day open-labeled pilot study of HFNT to determine the safety and feasibility of home use for daily outpatient COPD management. Patients ≥ 40 years of age with prior hospitalization within the past 12 weeks for an acute COPD exacerbation were enrolled. COPD as the primary diagnosis in all patients.
Results


Thirty patients presented for HFNT titration. Two dropped out; one after receiving a lung transplant and the other was lost to follow-up. The remaining 28 patients completed 90 days of HFNT. None withdrew from HFNT due to intolerance. Use of HFNT averaged 6.8 (2.1) hours daily.
Conclusions


Daily home HFNT for up to three months is feasible in COPD patients following hospitalization for an acute exacerbation. Improvements observed in disease specific quality of life, respiratory symptoms and 6 MWD suggest the need for a prospective multicenter controlled clinical trial.",2021,"Improvements observed in disease specific quality of life, respiratory symptoms and 6 MWD suggest the need for a prospective multicenter controlled clinical trial.","['Thirty patients presented for HFNT titration', 'patients recently hospitalized for a COPD exacerbation', 'Patients ≥ 40 years of age with prior hospitalization within the past 12 weeks for an acute COPD exacerbation were enrolled', 'COPD patients following hospitalization for an acute exacerbation', 'Methods\n\n\nPatients were enrolled in a 90-day open-labeled pilot study of', 'COPD Patients Following a Recent COPD Hospitalization', 'patients hospitalized with acute hypoxemic respiratory failure']","['Rationale\n\n\nHigh-flow nasal therapy (HFNT', 'Daily Home High-Flow Nasal Therapy', 'HFNT']","['tolerated flow rates and temperature, and side effects', 'disease specific quality of life, respiratory symptoms']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}]","[{'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}]",,0.0176049,"Improvements observed in disease specific quality of life, respiratory symptoms and 6 MWD suggest the need for a prospective multicenter controlled clinical trial.","[{'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Lii-Yoong H', 'Initials': 'LH', 'LastName': 'Criner', 'Affiliation': 'Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Sheril A', 'Initials': 'SA', 'LastName': 'George', 'Affiliation': 'Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Jiji K', 'Initials': 'JK', 'LastName': 'Thomas', 'Affiliation': 'Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jacobs', 'Affiliation': ''}]","Chronic obstructive pulmonary diseases (Miami, Fla.)",['10.15326/jcopdf.2021.0236']
2907,34748679,A Virtual Reality System for Pain and Anxiety Management during Outpatient Hysteroscopy- A Randomized-Control Trial.,"BACKGROUND


Visual and acoustic virtual reality (VR) has been increasingly explored as a non-pharmacological tool for pain relief in clinical settings.
OBJECTIVE


We aimed to evaluate the effectiveness of VR as a distraction technique in the management of acute pain during operative hysteroscopy in the outpatient setting.
METHODS


A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 82 women were randomly allocated to undergo operative hysteroscopy either with the use of VR (n = 44, study group) or with standard treatment (control group, n = 38). VR was applied throughout the procedure and no anesthesia was given. The primary outcome measures included self-reported intraoperative pain. Other objectives included vital parameters as pulse rate (PR) and respiratory rate (RR) before and during the first 3 minutes of the procedure. Pain and anxiety outcomes were measured as numeric rating scores.
RESULTS


The baseline parameters were similar between groups. The mean duration for the procedure was 8.1 ±3.2 vs. 7.3± 6.0 minutes for the study and the control groups (p = 0.23). There were no statistically significant differences between the reported pain scores during the procedure [median (interquartile range) 5.0 (3.0-7.2) vs 5.0 (3.0-8.0), respectively; P = .67]. While neither intraoperative heart rate nor respiratory rate differed between groups [14.0 (13.0-16.0) vs 14.0 (11.0-16.5); P = .77)], the increase of heart rate was found greater in the VR group [+7.0 (8.5) vs. +1.0 (12.2); P = .01].
CONCLUSION


VR was not effective in reducing pain during an outpatient operative hysteroscopy.",2021,"While neither intraoperative heart rate nor respiratory rate differed between groups [14.0 (13.0-16.0) vs 14.0 (11.0-16.5); P = .77)], the increase of heart rate was found greater in the VR group [+7.0 (8.5) vs. +1.0 (12.2); P = .01].
","['tertiary university-affiliated medical center between April to August 2020', '82 women']","['Visual and acoustic virtual reality (VR', 'operative hysteroscopy either with the use of VR', 'VR']","['mean duration for the procedure', 'pain', 'pulse rate (PR) and respiratory rate (RR', 'heart rate', 'self-reported intraoperative pain', 'numeric rating scores', 'pain scores', 'Pain and anxiety outcomes', 'intraoperative heart rate nor respiratory rate']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",82.0,0.0383238,"While neither intraoperative heart rate nor respiratory rate differed between groups [14.0 (13.0-16.0) vs 14.0 (11.0-16.5); P = .77)], the increase of heart rate was found greater in the VR group [+7.0 (8.5) vs. +1.0 (12.2); P = .01].
","[{'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Fouks', 'Affiliation': 'Lis Hospital for Women, Department of Obstetrics and Gynecology, Affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Kern', 'Affiliation': 'Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Aviad', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Lis Hospital for Women, Department of Obstetrics and Gynecology, Affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Reicher', 'Affiliation': 'Lis Hospital for Women, Department of Obstetrics and Gynecology, Affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Shapira', 'Affiliation': 'Lis Hospital for Women, Department of Obstetrics and Gynecology, Affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Many', 'Affiliation': 'Lis Hospital for Women, Department of Obstetrics and Gynecology, Affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Yariv', 'Initials': 'Y', 'LastName': 'Yogev', 'Affiliation': 'Lis Hospital for Women, Department of Obstetrics and Gynecology, Affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Gilad', 'Initials': 'G', 'LastName': 'Rattan', 'Affiliation': 'Lis Hospital for Women, Department of Obstetrics and Gynecology, Affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}]","European journal of pain (London, England)",['10.1002/ejp.1882']
2908,34748672,"Efficacy and Safety of Ocrelizumab in Patients with Relapsing-Remitting Multiple Sclerosis with Suboptimal Response to Prior Disease-Modifying Therapies: Primary Analysis from the Phase 3b CASTING Single-Arm, Open-Label Trial.","BACKGROUND


Using the treatment goal of 'no evidence of disease activity' (NEDA) incorporating MRI rebaselining, we assessed the efficacy of ocrelizumab in patients with relapsing-remitting multiple sclerosis with a prior suboptimal response, defined by MRI or relapse criteria, to one or two disease-modifying therapies (DMTs).
METHODS


CASTING was a prospective, international, multicenter, single-arm, open-label phase III trial (NCT02861014). Patients (Expanded Disability Status Scale [EDSS] score ≤4.0; discontinued prior DMT of ≥6 months duration due to suboptimal disease control) received intravenous ocrelizumab 600 mg every 24 weeks for 96 weeks. The primary endpoint was NEDA (defined as: absence of relapses, disability progression, and inflammatory MRI measures, with prespecified MRI rebaselining at Week 8) over 96 weeks.
RESULTS


A total of 680 patients were enrolled, 167 (24.6%) based on MRI activity only. At Week 96, 74.8% (95% CI, 71.3-78.0; n/N=492/658) of patients had NEDA. NEDA was highest among patients enrolled due to MRI activity alone (80.6% [68.6-89.6] n/N=50/62) versus for relapse (75.1% [69.0-80.6] n/N=172/229) or relapse with MRI (70.5% [60.0-79.0] n/N=74/105). NEDA across subgroups was highest in patients with baseline EDSS score <2.5 (77.2% [72.8-81.2] n/N=315/408). NEDA was higher in patients receiving one prior DMT (77.6% [73.2-81.6] n/N=312/402) versus two (70.3% [64.3-75.8] n/N=180/256).
CONCLUSIONS


In patients switching therapy due to suboptimal disease control, treatment with ocrelizumab led to an overall high NEDA rate across a wide range of disease-related and demographic subgroups, regardless of prior treatment background, with no new safety signals detected.",2021,"In patients switching therapy due to suboptimal disease control, treatment with ocrelizumab led to an overall high NEDA rate across a wide range of disease-related and demographic subgroups, regardless of prior treatment background, with no new safety signals detected.","['patients with relapsing-remitting multiple sclerosis with a prior suboptimal response, defined by MRI or relapse criteria, to one or two disease-modifying therapies (DMTs', '680 patients were enrolled, 167 (24.6%) based on MRI activity only', 'Patients with Relapsing-Remitting Multiple Sclerosis with Suboptimal Response to Prior Disease-Modifying Therapies']","['Ocrelizumab', 'ocrelizumab']","['NEDA', 'NEDA (defined as: absence of relapses, disability progression, and inflammatory MRI measures, with prespecified MRI rebaselining at Week', 'Efficacy and Safety', 'relapse with MRI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}]","[{'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",680.0,0.0675126,"In patients switching therapy due to suboptimal disease control, treatment with ocrelizumab led to an overall high NEDA rate across a wide range of disease-related and demographic subgroups, regardless of prior treatment background, with no new safety signals detected.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': 'Univ. Lille, Inserm U1172 LilNCog, CHU Lille, FHU Precise, Lille, France.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Oreja-Guevara', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Aksel', 'Initials': 'A', 'LastName': 'Siva', 'Affiliation': 'Istanbul University Cerrahpasa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Van Wijmeersch', 'Affiliation': 'University MS Centre, Pelt, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wiendl', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wuerfel', 'Affiliation': 'Medical Image Analysis Center (MIAC AG) and Dept. Biomedical Engineering, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Buffels', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kadner', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuenzel', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Vita-Salute San Raffaele University, Milan Casa di Cura del Policlinico, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of neurology,['10.1111/ene.15171']
2909,34749132,A protein-supplemented very-low-calorie diet does not mitigate reductions in lean mass and resting metabolic rate in subjects with overweight or obesity: A randomized controlled trial.,"BACKGROUND & AIMS


The European Food Safety Authority recently recommended an increase in the protein content of total diet replacement (TDR) products from 50 to 75 g/day. The rationale was to minimize reductions in lean mass (LM) and resting metabolic rate (RMR) that occur with weight loss, and thereby facilitate maintenance of lost weight. We sought to directly compare the efficacy of TDR regimens with the new vs the current protein requirement.
METHODS


We randomized 108 adults with overweight or obesity (body mass index 28-40 kg/m 2 ) to very-low-calorie diets (VLCD) with either 52 or 77 g/day protein for 8 weeks (total energy intake of 600 or 700 kcal/day, respectively). LM was determined by dual energy X-ray absorptiometry and RMR by indirect calorimetry.
RESULTS


Attrition rate was 22% in both groups. Both VLCDs decreased body weight, fat mass, LM, and RMR (all P < 0.05). Significant time-by-group interactions were detected for weight and fat mass (both P < 0.05), with corresponding reductions being smaller in the higher-protein than the standard-protein VLCD, likely because of the added calories. On the other hand, reductions in LM (6% from baseline) and RMR (9-10% from baseline) did not differ between groups (P = 0.155 and P = 0.389, respectively), and the contribution of LM to total weight loss was identical (27 ± 2% of lost weight, P = 0.973).
CONCLUSIONS


Our results indicate that the proposed increase in the protein content of TDR products does not attenuate reductions in LM and RMR in individuals with overweight and obesity who are treated with <800 kcal/day VLCDs for 2 months.
CLINICAL TRIAL REGISTRY


ClinicalTrials.gov # NCT04156165.",2021,"Both VLCDs decreased body weight, fat mass, LM, and RMR (all P < 0.05).","['subjects with overweight or obesity', '108 adults with overweight or obesity (body mass index 28-40\xa0kg/m 2 ) to very-low-calorie diets (VLCD) with either 52 or 77\xa0g/day protein for 8 weeks (total energy intake of 600 or 700\xa0kcal/day, respectively']",['protein-supplemented very-low-calorie diet'],"['weight and fat mass', 'lean mass and resting metabolic rate', 'body weight, fat mass, LM, and RMR', 'lean mass (LM) and resting metabolic rate (RMR', 'LM', 'RMR', 'Attrition rate', 'contribution of LM to total weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",108.0,0.114801,"Both VLCDs decreased body weight, fat mass, LM, and RMR (all P < 0.05).","[{'ForeName': 'Faidon', 'Initials': 'F', 'LastName': 'Magkos', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark. Electronic address: fma@nexs.ku.dk.'}, {'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Asping', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Rosenkrans', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Sidse I', 'Initials': 'SI', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Sjödin', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Nina R W', 'Initials': 'NRW', 'LastName': 'Geiker', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.10.006']
2910,34764663,Acarbose Reduces Low-Grade Albuminuria Compared to Metformin in Chinese Patients with Newly Diagnosed Type 2 Diabetes.,"Purpose


To assess the effect of acarbose in lowering low-grade albuminuria compared to metformin in newly diagnosed Chinese type 2 diabetes (T2DM) patients.
Patients and Methods


The Metformin and AcaRbose Clinical Trial was a randomized, open-label trial in newly diagnosed T2DM patients. Participants received 48 weeks of monotherapy with acarbose (100 mg three times a day) or metformin (1500 mg once a day). As the hypoglycemic effect of acarbose and metformin has been evaluated in previous reports. This analysis studied the effect of the two antidiabetic drugs on reducing urinary albumin. The percent change in the urinary albumin/creatinine ratio (uACR) from baseline to week 48 was analyzed, and ANCOVA was employed to establish whether the effect in decreasing uACR was mediated by metabolic improvement.
Results


Acarbose reduced the adjusted mean percent uACR by -31.5% (95% confidence interval [CI] -48.4 to -7.5) compared with metformin. When adjusting for changes in glycated hemoglobin, body weight, systolic blood pressure and triglycerides or changes in area under the curve of glucagon-like peptide 1 (AUCGLP-1) in the standard meal test, the uACR-lowering effect was not attenuated. If stratified by eGFR, blood glucose level, sex or uACR level, the effect of acarbose versus metformin was consistent across subgroups. The proportion of patients with a reduction in uACR of at least 70% was 48.6% in the acarbose group and 34.1% in the metformin group.
Conclusion


Acarbose lowered the uACR compared to metformin in newly diagnosed T2DM patients independent of improvements in hyperglycemia, blood pressure, body weight and triglycerides.",2021,"Results


Acarbose reduced the adjusted mean percent uACR by -31.5% (95% confidence interval [CI] -48.4 to -7.5) compared with metformin.","['newly diagnosed T2DM patients', 'Chinese Patients with Newly Diagnosed Type 2 Diabetes', 'newly diagnosed Chinese type 2 diabetes (T2DM) patients']","['acarbose versus metformin', 'acarbose', 'Metformin', 'monotherapy with acarbose', 'acarbose and metformin', 'Metformin and AcaRbose', 'Acarbose', 'metformin']","['glycated hemoglobin, body weight, systolic blood pressure and triglycerides or changes in area under the curve of glucagon-like peptide 1 (AUCGLP-1', 'blood glucose level, sex or uACR level', 'uACR', 'urinary albumin/creatinine ratio (uACR', 'urinary albumin', 'Low-Grade Albuminuria', 'hyperglycemia, blood pressure, body weight and triglycerides']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3871467', 'cui_str': 'metformin and acarbose'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.145187,"Results


Acarbose reduced the adjusted mean percent uACR by -31.5% (95% confidence interval [CI] -48.4 to -7.5) compared with metformin.","[{'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ""Department of Endocrinology, China-Japan Friendship Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaomu', 'Initials': 'X', 'LastName': 'Kong', 'Affiliation': ""Clinical Laboratory, China-Japan Friendship Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Zhaojun', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, China-Japan Friendship Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology, China-Japan Friendship Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, China-Japan Friendship Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology, China-Japan Friendship Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology, China-Japan Friendship Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, China-Japan Friendship Hospital, Beijing, People's Republic of China.""}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S325683']
2911,34764661,Effect of Metformin on Breast Density in Overweight/Obese Premenopausal Women.,"Background


This study investigated the effects of metformin on breast density in overweight/obese premenopausal women.
Methods


Overweight/obese premenopausal women (n=120) were randomly assigned to the metformin or placebo group, and all women received lifestyle interventions. The outcomes included weight, BMI, FPG, FIN, glucose, HOMA-IR, LDL-C, HDL-C, TG, TC, SBP, DBP, FSH, E, AD, and the BIRADS grade, and the incidence of breast cancer was assessed by pathological biopsy and BIRADS grade greater than 4.
Results


In total, 120 overweight/obese women completed the 1-year trial. Seven patients had a BIRADS grade greater than 4, including 5 patients who were biopsy positive, in the control group, and 2 patients had a BIRADS grade greater than 4, including 1 patient who was biopsy positive, in the metformin group. Compared with those in the control group, the body weight, BMI, FIN, FPG, HOMA-IR, TC, BIRADS grade and positive pathological biopsy rate in the metformin group were significantly decreased (P<0.05), while AD was significantly increased (P<0.05). The correlation analysis indicated that the BIRADS grade was significantly correlated with weight, BMI, FPG, FIN, HOMA-IR, SBP, AD and the positive pathological biopsy rate, and the positive pathological biopsy rate was significantly correlated with weight, BMI, HOMA-IR, SBP, AD and BIRADS grade. The logistic regression analysis revealed that the BIRADS grade was significantly correlated with the positive pathological biopsy rate and AD and that the positive pathological biopsy rate was significantly correlated with the BIRADS grade.
Conclusion


As adjunctive therapy, the combination of lifestyle changes and metformin was found to be a safe strategy for improving related metabolic markers and increasing adiponectin. The BIRADS grade was significantly correlated with the positive pathological biopsy rate and AD, and the positive pathological biopsy rate was significantly correlated with the BIRADS grade.",2021,"Compared with those in the control group, the body weight, BMI, FIN, FPG, HOMA-IR, TC, BIRADS grade and positive pathological biopsy rate in the metformin group were significantly decreased (P<0.05), while AD was significantly increased (P<0.05).","['120 overweight/obese women completed the 1-year trial', 'overweight/obese premenopausal women', 'Overweight/Obese Premenopausal Women', 'Methods\n\n\nOverweight/obese premenopausal women (n=120']","['lifestyle interventions', 'metformin or placebo', 'Metformin', 'metformin']","['weight, BMI, HOMA-IR, SBP, AD and BIRADS grade', 'positive pathological biopsy rate and AD', 'positive pathological biopsy rate', 'weight, BMI, FPG, FIN, glucose, HOMA-IR, LDL-C, HDL-C, TG, TC, SBP, DBP, FSH, E, AD, and the BIRADS grade, and the incidence of breast cancer', 'weight, BMI, FPG, FIN, HOMA-IR, SBP, AD and the positive pathological biopsy rate, and the positive pathological biopsy rate', 'positive pathological biopsy rate and AD, and the positive pathological biopsy rate', 'body weight, BMI, FIN, FPG, HOMA-IR, TC, BIRADS grade and positive pathological biopsy rate']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",120.0,0.0867063,"Compared with those in the control group, the body weight, BMI, FIN, FPG, HOMA-IR, TC, BIRADS grade and positive pathological biopsy rate in the metformin group were significantly decreased (P<0.05), while AD was significantly increased (P<0.05).","[{'ForeName': 'Weiling', 'Initials': 'W', 'LastName': 'Leng', 'Affiliation': ""Endocrinology Department, The First Affiliated Hospital of the Third Military Medical University (Army Medical University), Chongqing, People's Republic of China.""}, {'ForeName': 'Danlan', 'Initials': 'D', 'LastName': 'Pu', 'Affiliation': ""Endocrinology and Nephrology Department, Chongqing University Cancer Hospital and Chongqing Cancer Institute and Chongqing Cancer Hospital, Chongqing, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Endocrinology and Nephrology Department, Chongqing University Cancer Hospital and Chongqing Cancer Institute and Chongqing Cancer Hospital, Chongqing, People's Republic of China.""}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': ""Endocrinology Department, The First Affiliated Hospital of the Third Military Medical University (Army Medical University), Chongqing, People's Republic of China.""}, {'ForeName': 'Qinan', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Endocrinology Department, Chongqing Medical University Affiliated Dazu Hospital, Dazu District People's Hospital, Chongqing, People's Republic of China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Endocrinology Department, The First Affiliated Hospital of the Third Military Medical University (Army Medical University), Chongqing, People's Republic of China.""}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S330625']
2912,34765076,Tissue based biomarkers in non-clear cell RCC: Correlative analysis from the ASPEN clinical trial.,"Biomarkers are needed in patients with non-clear cell renal cell carcinomas (NC-RCC), particularly papillary renal cell carcinoma, in order to inform on initial treatment selection and identify potentially novel targets for therapy. We enrolled 108 patients in ASPEN, an international randomized open-label phase 2 trial of patients with metastatic papillary, chromophobe, or unclassified NC-RCC treated with the mTOR inhibitor everolimus (n=57) or the vascular endothelial growth factor (VEGF) receptor inhibitor sunitinib (n=51), stratified by MSKCC risk and histology. The primary endpoint was overall survival (OS) and secondary efficacy endpoints for this exploratory biomarker analysis were radiographic progression-free survival (rPFS) defined by intention-to-treat using the RECIST 1.1 criteria and radiographic response rates. Tissue biomarkers (n=78) of mTOR pathway activation (phospho-S6 and -Akt, c-kit) and VEGF pathway activation (HIF-1α, c-MET) were prospectively explored in tumor tissue by immunohistochemistry prior to treatment and associated with clinical outcomes. We found that S6 activation was more common in poor risk NC-RCC tumors and S6/Akt activation was associated with worse PFS and OS outcomes with both everolimus and sunitinib, while c-kit was commonly expressed in chromophobe tumors and associated with improved outcomes with both agents. C-MET was commonly expressed in papillary tumors and was associated with lower rates of radiographic response but did not predict PFS for either agent. In multivariable analysis, both pAkt and c-kit were statistically significant prognostic biomarkers of OS. No predictive biomarkers of treatment response were identified for clinical outcomes. Most biomarker subgroups had improved outcomes with sunitinib as compared to everolimus.",2021,C-MET was commonly expressed in papillary tumors and was associated with lower rates of radiographic response but did not predict PFS for either agent.,"['108 patients in ASPEN, an international randomized open-label phase 2 trial of patients with metastatic papillary, chromophobe, or unclassified NC-RCC treated with the', 'patients with non-clear cell renal cell carcinomas (NC-RCC), particularly papillary renal cell carcinoma']",['mTOR inhibitor everolimus (n=57) or the vascular endothelial growth factor (VEGF) receptor inhibitor sunitinib'],"['PFS and OS outcomes', 'radiographic progression-free survival (rPFS) defined by intention-to-treat using the RECIST 1.1 criteria and radiographic response rates', 'radiographic response', 'overall survival (OS) and secondary efficacy endpoints']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0205426', 'cui_str': 'Unclassified'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}]","[{'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",108.0,0.189184,C-MET was commonly expressed in papillary tumors and was associated with lower rates of radiographic response but did not predict PFS for either agent.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham NC.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham NC.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carmack', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham NC.'}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham NC.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Foo', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham NC.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Eisen', 'Affiliation': 'University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Stadler', 'Affiliation': 'University of Chicago, Chicago, IL USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow, The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Garcia', 'Affiliation': 'Cleveland Clinic, Cleveland, OH USA.'}, {'ForeName': 'Ulka N', 'Initials': 'UN', 'LastName': 'Vaishampayan', 'Affiliation': 'University of Michigan, Ann Arbor/Karmanos Cancer Institute, Wayne State University, Detroit, MI USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Picus', 'Affiliation': 'Washington University in St. Louis, St. Louis, MO USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Hawkins', 'Affiliation': 'Christie Cancer Research Centre, Manchester, United Kingdom.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hainsworth', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN USA.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'BC Cancer Agency, Vancouver Cancer Centre, Vancouver, BC Canada.'}, {'ForeName': 'Theodore F', 'Initials': 'TF', 'LastName': 'Logan', 'Affiliation': 'Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Puzanov', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pickering', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Ryan', 'Affiliation': 'Oregon Health & Science University, OHSU Knight Cancer Institute, Portland, OR USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Protheroe', 'Affiliation': 'University of Oxford Medical Oncology Department, Oxford, United Kingdom.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': 'Duke University and the Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Duke University and the Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC.'}]",Kidney cancer journal : official journal of the Kidney Cancer Association,['10.52733/kcj19n3-a1']
2913,34765010,The Feasibility of Tai Chi Exercise as a Beneficial Mind-Body Intervention in a Group of Community-Dwelling Stroke Survivors with Symptoms of Depression.,"Depression is prevalent among one-third to two-thirds of acute and chronic stroke survivors. Despite the availability of pharmacotherapies and/or psychotherapies, depression persists, even for 5-10 years after stroke, reflecting limited treatment responses and/or adherence to this conventional care. Mind-body interventions are commonly used among adults to ameliorate depressive symptoms. Thus, the feasibility of Tai Chi, alongside conventional care, to manage poststroke depression was investigated using a single-group pre-post intervention design. Recruitment and retention, intervention adherence, safety, acceptability, and fidelity were assessed. Symptoms of depression, anxiety, and stress were assessed using standardized questionnaires, objective sleep was assessed via a research-grade triaxial accelerometer, and blood samples were taken to measure oxidative stress, inflammatory markers, and a neurotrophic growth factor using commercially available kits per manufacturer's protocol. Pre-post intervention changes were assessed using paired  t -tests. We enrolled stroke survivors ( N  = 11, mean age = 69.7 ± 9.3) reporting depression symptoms. After the intervention, we observed significant reductions in symptoms of depression (-5.3 ± 5.9,  p =0.01), anxiety (-2.2 ± 2.4,  p =0.01), and stress (-4.6 ± 4.8,  p =0.01), along with better sleep efficiency (+1.8 ± 1.8,  p =0.01), less wakefulness after sleep onset (-9.3 ± 11.6,  p =0.04), and less time awake (-9.3 ± 11.6,  p =0.04). There was a 36% decrease in oxidative stress ( p =0.02), though no significant changes in the other biomarkers were found (all  p  values >0.05). Tai Chi exercise is a feasible intervention that can be used alongside conventional care to manage poststroke depression, aid in reducing symptoms of anxiety and stress, and improve sleep.",2021,"There was a 36% decrease in oxidative stress ( p =0.02), though no significant changes in the other biomarkers were found (all  p  values >0.05).","['Community-Dwelling Stroke Survivors with Symptoms of Depression', 'enrolled stroke survivors ( N \u2009=\u200911, mean age\u2009=\u200969.7\u2009±\u20099.3) reporting depression symptoms']","['Tai Chi Exercise', 'Tai Chi exercise']","['anxiety', 'wakefulness after sleep onset', 'symptoms of depression', 'Symptoms of depression, anxiety, and stress were assessed using standardized questionnaires, objective sleep was assessed via a research-grade triaxial accelerometer, and blood samples', 'sleep efficiency', 'Recruitment and retention, intervention adherence, safety, acceptability, and fidelity', 'oxidative stress']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.00896415,"There was a 36% decrease in oxidative stress ( p =0.02), though no significant changes in the other biomarkers were found (all  p  values >0.05).","[{'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Taylor-Piliae', 'Affiliation': 'College of Nursing, University of Arizona, Tucson, AZ 85721, USA.'}, {'ForeName': 'Helena W', 'Initials': 'HW', 'LastName': 'Morrison', 'Affiliation': 'College of Nursing, University of Arizona, Tucson, AZ 85721, USA.'}, {'ForeName': 'Chiu-Hsieh Paul', 'Initials': 'CP', 'LastName': 'Hsu', 'Affiliation': 'College of Public Health, University of Arizona, Tucson, AZ 85724, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Whitman', 'Affiliation': 'College of Nursing, University of Arizona, Tucson, AZ 85721, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grandner', 'Affiliation': 'College of Medicine, University of Arizona, Tucson, AZ 85724, USA.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/8600443']
2914,34765229,Efficacy of high-volume injections with and without corticosteroid compared with sham for Achilles tendinopathy: a protocol for a randomised controlled trial.,"Introduction


Achilles tendinopathy (AT) is a common and disabling musculoskeletal condition. First-line management involving Achilles tendon loading exercise with, or without, other modalities may not resolve the problem in up to 44% of cases. Many people receive injections. Yet there are no injection treatments with demonstrated long-term efficacy. The aim of the trial is to examine the 12-month efficacy of high-volume injection (HVI) with corticosteroid and HVI without corticosteroid versus sham injection among individuals with AT.
Methods and analysis


The trial is a three-arm, parallel group, double-blind, superiority randomised controlled trial that will assess the efficacy of HVI with and without corticosteroid versus sham up to 12 months. We will block-randomise 192 participants to one of the three groups with a 1:1:1 ratio, and both participants and outcome assessors will be blinded to treatment allocation. All participants will receive an identical evidence-based education and exercise intervention. The primary outcome measure will be the Victorian Institute of Sport Assessment - Achilles (VISA-A) at 12 months post-randomisation, a validated, reliable and disease-specific measure of pain and function. Choice of secondary outcomes was informed by core outcome domains for tendinopathy. Data will be analysed using the intention-to-treat principle.
Ethics and dissemination


Ethics approval was obtained via the Monash University Human Ethics Committee (no: 13138). The study is expected to be completed in 2024 and disseminated via peer review publication and conference presentations.
Trial registration number


Australia and New Zealand Clinical trials registry (ACTRN12619001455156).",2021,"(VISA-A) at 12 months post-randomisation, a validated, reliable and disease-specific measure of pain and function.","['Trial registration number\n\n\nAustralia and New Zealand', 'individuals with AT', 'Achilles tendinopathy']","['high-volume injection (HVI) with corticosteroid and HVI without corticosteroid', 'high-volume injections with and without corticosteroid', 'HVI with and without corticosteroid', 'identical evidence-based education and exercise intervention']",['Victorian Institute of Sport Assessment - Achilles'],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}]",,0.805545,"(VISA-A) at 12 months post-randomisation, a validated, reliable and disease-specific measure of pain and function.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malliaras', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Frankston, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Connell', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Frankston, Victoria, Australia.'}, {'ForeName': 'Anders Ploug', 'Initials': 'AP', 'LastName': 'Boesen', 'Affiliation': 'Department of Orthopaedic Surgery, Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Kearney', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, West Midlands, UK.'}, {'ForeName': 'Hylton B', 'Initials': 'HB', 'LastName': 'Menz', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Morrissey', 'Affiliation': 'Sports and Exercise Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Munteanu', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Karin G', 'Initials': 'KG', 'LastName': 'Silbernagel', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, West Midlands, UK.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Frankston, Victoria, Australia.'}]",BMJ open sport & exercise medicine,['10.1136/bmjsem-2021-001136']
2915,34750692,Does arthroscopic patellar denervation with high tibial osteotomy improve anterior knee pain?,"PURPOSE


Patellofemoral (PF) joint osteoarthritis (OA) is a major cause of anterior knee pain. Combined PF and medial tibiofemoral (TF) OA is common in older adults. We evaluated the effect of arthroscopic patellar denervation (PD) in patients with combined TF and PFOA after malalignment correction.
METHODS


Forty-five patients [females/males, 27/18; age, 30-59 years (45.5 ± 8.50); mean body mass index, 25.15 ± 3.04 kg/m 2 ] were treated in our department from March 2017 to March 2019. The patients were randomised into 2 groups: group A included 22 patients who underwent open-wedge high tibial osteotomy (OWHTO) and arthroscopic PD and group B included 23 patients who underwent OWHTO without denervation. The effect of denervation was statistically and clinically evaluated using the Knee injury and Osteoarthritis Outcome Score (KOOS) and Kujala (anterior knee pain score) score.
RESULTS


After 24 months, 40 patients were available for the final follow-up. The final values of KOOS and the Kujala score were significantly different between the groups (p < 0.001). For group A, the average KOOS improved from 42.73 to 72.38 (p < 0.001) and the Kujala score improved from 42 to 74.1 (p < 0.001), whereas in group B, the average KOOS improved from 39.22 to 56.84 (p < 0.001) and the Kujala score improved from 39.7 to 56.4 (p < 0.001).
CONCLUSION


Adding arthroscopic PD to OWHTO relieves anterior knee pain in patients with combined TF and PFOA and improves knee joint function and quality of life.
LEVEL OF EVIDENCE


Level I prospective randomised control clinical trial.",2021,"For group A, the average KOOS improved from 42.73 to 72.38 (p < 0.001) and the Kujala score improved from 42 to 74.1 (p < 0.001), whereas in group B, the average KOOS improved from 39.22 to 56.84 (p < 0.001) and the Kujala score improved from 39.7 to 56.4 (p < 0.001).
","['patients with combined TF and', 'older adults', '22 patients who underwent', 'patients with combined TF and PFOA after malalignment correction', 'Forty-five patients [females/males, 27/18; age, 30-59\u2009years (45.5\u2009±\u20098.50); mean body mass index, 25.15\u2009±\u20093.04\u2009kg/m 2 ] were treated in our department from March 2017 to March 2019']","['PFOA', 'arthroscopic patellar denervation (PD', 'Combined PF and medial tibiofemoral (TF) OA', 'open-wedge high tibial osteotomy (OWHTO) and arthroscopic PD and group B included 23 patients who underwent OWHTO without denervation', 'arthroscopic patellar denervation with high tibial osteotomy']","['average KOOS', 'knee joint function and quality of life', 'final values of KOOS and the Kujala score', 'Kujala score', 'anterior knee pain', 'Knee injury and Osteoarthritis Outcome Score (KOOS) and Kujala (anterior knee pain score) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0445153', 'cui_str': 'Opening wedge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}]",40.0,0.0422764,"For group A, the average KOOS improved from 42.73 to 72.38 (p < 0.001) and the Kujala score improved from 42 to 74.1 (p < 0.001), whereas in group B, the average KOOS improved from 39.22 to 56.84 (p < 0.001) and the Kujala score improved from 39.7 to 56.4 (p < 0.001).
","[{'ForeName': 'Mohamed Kamel Mohamed', 'Initials': 'MKM', 'LastName': 'Said', 'Affiliation': 'Faculty of Medicine, Assiut University, Assiut, 71515, Egypt. mohamed.sayedp31@med.au.edu.eg.'}, {'ForeName': 'Hatem G', 'Initials': 'HG', 'LastName': 'Said', 'Affiliation': 'Faculty of Medicine, Assiut University, Assiut, 71515, Egypt.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Elkady', 'Affiliation': 'Faculty of Medicine, Assiut University, Assiut, 71515, Egypt.'}, {'ForeName': 'Mahmoud Kamel Mohamed', 'Initials': 'MKM', 'LastName': 'Said', 'Affiliation': 'Faculty of Medicine, Assiut University, Assiut, 71515, Egypt.'}, {'ForeName': 'Islam Karam-Allah', 'Initials': 'IK', 'LastName': 'Ramadan', 'Affiliation': 'Faculty of Medicine, Assiut University, Assiut, 71515, Egypt.'}, {'ForeName': 'Mohamed Abd', 'Initials': 'MA', 'LastName': 'El-Radi', 'Affiliation': 'Faculty of Medicine, Assiut University, Assiut, 71515, Egypt.'}]",Journal of experimental orthopaedics,['10.1186/s40634-021-00411-5']
2916,34750670,Local vancomycin therapy to reduce surgical site infection in adult spine surgery: a randomized prospective study.,"PURPOSE


This prospective randomized controlled trial hypothesizes that intra wound vancomycin reduces postoperative infection.
METHODS


In this RCT study, the patients were randomly divided into two groups of treatment and control. In the treatment group, 1-2 g of intra wound vancomycin was used, and no drug was used for the control group. SSI and the type of microorganism causing postoperative infection were assessed at a three-month follow-up. Factors affecting postoperative infection such as age, sex, site of operation, surgical levels, and risk factors affecting postoperative infection, such as diabetes, blood pressure, ischemic heart disease, smoking, blood transfusion, BMI, neurologic deficit, CSF leakage, UTI, COPD and surgery time were examined in two groups.
RESULTS


In this study, 375 patients, including 187patients in the treatment group and 188 patients in the control group, were studied. Among the patients, 228 had surgery without instrumentation, and 147 had surgery with instrumentation. There were 12 cases of SSI in the treatment group and 11 in the control group, and there was no statistically significant difference between the two groups. There was no difference between the two groups with and without instrumentation in the evaluation of postoperative infection. In the subgroups with and without instruments, there was no significant difference between treatment and control groups. Due to the microorganism causing the infection, gram-negative bacteria were more common in the treatment group.
CONCLUSION


Intra-wound vancomycin has no effect on SSI; in addition, it can increase the rate of gram-negative infections.",2021,There was no difference between the two groups with and without instrumentation in the evaluation of postoperative infection.,"['adult\xa0spine surgery', '375 patients, including 187patients in the treatment group and 188 patients in the control group, were studied', 'patients, 228 had surgery without instrumentation, and 147 had surgery with instrumentation']","['Local vancomycin therapy', 'vancomycin']","['SSI', 'surgical site infection', 'diabetes, blood pressure, ischemic heart disease, smoking, blood transfusion, BMI, neurologic deficit, CSF leakage, UTI, COPD and surgery time', 'postoperative infection', 'rate of gram-negative infections']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0023182', 'cui_str': 'Cerebrospinal fluid leak'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",375.0,0.0398058,There was no difference between the two groups with and without instrumentation in the evaluation of postoperative infection.,"[{'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Salimi', 'Affiliation': 'Clinical Research and Development Unit, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Khayat Kashani', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran. hrkhka@gmail.com.'}, {'ForeName': 'Shirzad', 'Initials': 'S', 'LastName': 'Azhari', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Sheikhghomy', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran.'}, {'ForeName': 'Poorya', 'Initials': 'P', 'LastName': 'Paryan', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'KhayatKashani', 'Affiliation': 'Clinical Research and Development Unit, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-021-07050-5']
2917,34751046,Efficacy and safety of vitamin supplements with resveratrol in diabetic macular edema: Long-term results of a comparative study.,"PURPOSE


To investigate the adjunct efficacy and safety of vitamin supplements, including resveratrol, in patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial factor (anti-VEGF) agents.
METHODS


Participants in this prospective study were 45 patients with DME, who were treated with either intravitreal anti-VEGF injections (n = 23, Group I) or with combination of intravitreal anti-VEGF injections and vitamin supplements, including resveratrol (n = 22, Group II). All patients underwent visual acuity measurement, slit-lamp examination and spectral domain-optical coherence tomography (SD-OCT) at baseline and monthly after the loading phase of three-monthly anti-VEGF injections, following a PRN protocol.
RESULTS


There was a statistically significant improvement in visual acuity in both groups at month 12 compared to baseline, although the mean change in visual acuity did not differ between the two groups (p = 0.183). Accordingly, there was a statistically significant decrease in central retinal thickness in both groups at month 12 compared to baseline, while the mean difference in central retinal thickness was significantly greater in the ""combination"" group. The mean number of intravitreal anti-VEGF injection was less in Group II (6.45 ± 1.12 in Group II vs. 7.39 ± 1.31 in Group I, p = 0.018).
CONCLUSIONS


Vitamin supplements with resveratrol was found to be an effective adjunct to intravitreal anti-VEGF injections in patients with DME, offering better anatomic restoration with less injections at the 12-month follow-up.",2021,"There was a statistically significant improvement in visual acuity in both groups at month 12 compared to baseline, although the mean change in visual acuity did not differ between the two groups (p = 0.183).","['patients with diabetic macular edema (DME) treated with', 'n\u2009=\u200923, Group I) or with', 'Participants in this prospective study were 45 patients with DME, who were treated with either', 'diabetic macular edema']","['intravitreal anti-VEGF injections', 'vitamin supplements', 'combination of intravitreal anti-VEGF injections and vitamin supplements, including resveratrol', 'intravitreal anti-vascular endothelial factor (anti-VEGF']","['central retinal thickness', 'visual acuity', 'Efficacy and safety', 'mean change in visual acuity', 'mean number of intravitreal anti-VEGF injection', 'visual acuity measurement, slit-lamp examination and spectral domain-optical coherence tomography (SD-OCT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]",45.0,0.049103,"There was a statistically significant improvement in visual acuity in both groups at month 12 compared to baseline, although the mean change in visual acuity did not differ between the two groups (p = 0.183).","[{'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Chatziralli', 'Affiliation': '2nd Department of Ophthalmology, 68993National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Dimitriou', 'Affiliation': '2nd Department of Ophthalmology, 68993National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Chatzirallis', 'Affiliation': '2nd Department of Ophthalmology, Ophthalmiatrion Athinon, Athens, Greece.'}, {'ForeName': 'Evaggelia', 'Initials': 'E', 'LastName': 'Aissopou', 'Affiliation': '2nd Department of Ophthalmology, 68993National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kazantzis', 'Affiliation': '2nd Department of Ophthalmology, 68993National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Theodossiadis', 'Affiliation': '2nd Department of Ophthalmology, 68993National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Theodossiadis', 'Affiliation': '2nd Department of Ophthalmology, 68993National and Kapodistrian University of Athens, Athens, Greece.'}]",European journal of ophthalmology,['10.1177/11206721211057682']
2918,34750975,Short-term effects of a social media-based intervention on the physical and mental health of remotely working young software professionals: A randomised controlled trial.,"The present study aimed to explore the short term effects of a social media-based intervention on the physical and mental health of the software professionals working remotely during the pandemic. Sixty software professionals with poor physical and mental health were randomised to Facebook-based intervention (FIIT) and a control (CONT) group for 2 months. Forty-six remote workers (26.25 ± 3.49 years) completed the study (FIIT = 22; CONT = 26). All the respondents had the median sitting time (7.07 ± 2.30 h/day) during office hours on workdays. We found a significant difference in the sitting time during office hours in workday within the subjects (F 1,46   = 4.66; p < .004; η p   2   = .048) and between the subjects (F 1,46   = 3.81; p < .004; η p   2   = .040). Post hoc analysis revealed participants in the FIIT group reduced their sitting time by 58 min during office hours during a typical workday compared with the control group. Nevertheless, we found a significant difference in the scores of stress, anxiety and depression within and between the groups. Short-term social media-based physical and mental health intervention may improve physical and mental health scores in the desk-based office workers working remotely.",2021,Short-term social media-based physical and mental health intervention may improve physical and mental health scores in the desk-based office workers working remotely.,"['Forty-six remote workers (26.25\u2009±\u20093.49\u2009years) completed the study (FIIT\u2009=\u200922; CONT\u2009=\u200926', 'Sixty software professionals with poor physical and mental health', 'remotely working young software professionals']","['Short-term social media-based physical and mental health intervention', 'Facebook-based intervention (FIIT) and a control (CONT', 'social media-based intervention']","['physical and mental health scores', 'median sitting time', 'scores of stress, anxiety and depression', 'sitting time']","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",46.0,0.0190205,Short-term social media-based physical and mental health intervention may improve physical and mental health scores in the desk-based office workers working remotely.,"[{'ForeName': 'Prabhu', 'Initials': 'P', 'LastName': 'Muniswamy', 'Affiliation': 'Department of Exercise and Sports Sciences, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Varadayini', 'Initials': 'V', 'LastName': 'Gorhe', 'Affiliation': 'Sports & Performance Psychology, MindFirst Performance, Pune, India.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Parashivakumar', 'Affiliation': 'RNR FIT Gymnastics Academy, Bangalore, India.'}, {'ForeName': 'Baskaran', 'Initials': 'B', 'LastName': 'Chandrasekaran', 'Affiliation': 'Department of Exercise and Sports Sciences, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, India.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12318']
2919,34751655,Home-Based Exercise Program for Patients With Combined Advanced Chronic Cardiac and Pulmonary Diseases: Exploratory Study.,"BACKGROUND


As chronic cardiac and pulmonary diseases often coexist, there is a need for combined physical home-based rehabilitation programs, specifically addressing older patients with advanced disease stages.
OBJECTIVE


The primary aim of this study is to evaluate the completion and adherence rates of an 8-week, home-based exercise program for patients with advanced cardiopulmonary disease. The secondary end points include patient satisfaction; adverse events; and program efficacy in terms of change in functional capacity, level of dyspnea, and health-related quality of life.
METHODS


The participants received a goal-oriented, home-based exercise program, and they used a wrist-worn activity tracker to record their exercise sessions. Activity tracker data were made visible on a digital platform, which was also equipped with several other features such as short instruction videos on how to perform specific exercises. The participants received weekly coaching by a physiotherapist and an occupational therapist through video communication.
RESULTS


In all, 10 patients with advanced combined cardiopulmonary disease participated (median age 71, IQR 63-75 years), and 50% (5/10) were men. Of the 10 participants, 9 (90%) completed the 8-week program. Median adherence to the exercise prescription was 75% (IQR 37%-88%), but it declined significantly when the program was divided into 2-week periods (first 2 weeks: 86%, IQR 51%-100%, and final 2 weeks: 57%, IQR 8%-75%; P=.03). The participants were highly satisfied with the program (Client Satisfaction Questionnaire: median score 29, IQR 26-32, and Purpose-Designed Questionnaire: median score 103, IQR 92-108); however, of the 9 participants, 4 (44%) experienced technical issues. The Patient-Specific Complaints Instrument scores declined, indicating functional improvement (from median 7.5, IQR 6.1-8.9, to median 5.7, IQR 3.8-6.7; P=.01). Other program efficacy metrics showed a trend toward improvement.
CONCLUSIONS


Home-based cardiopulmonary telerehabilitation for patients with severe combined cardiopulmonary disease is feasible in terms of high completion and satisfaction rates. Nevertheless, a decrease in adherence during the program was observed, and some of the participants reported difficulties with the technology, indicating the importance of the integration of behavior change techniques, using appropriate technology.
TRIAL REGISTRATION


Netherlands Trial Register NL9182; https://www.trialregister.nl/trial/9182.",2021,"Median adherence to the exercise prescription was 75% (IQR 37%-88%), but it declined significantly when the program was divided into 2-week periods (first 2 weeks: 86%, IQR 51%-100%, and final 2 weeks: 57%, IQR 8%-75%; P=.03).","['Patients With Combined Advanced Chronic Cardiac and Pulmonary Diseases', 'patients with severe combined cardiopulmonary disease', 'older patients with advanced disease stages', 'participants were highly satisfied with the program (Client Satisfaction Questionnaire: median score 29, IQR 26-32, and Purpose-Designed Questionnaire: median score 103, IQR 92-108); however, of the 9 participants, 4 (44%) experienced technical issues', 'patients with advanced cardiopulmonary disease', '10 participants, 9 (90%) completed the 8-week program', '10 patients with advanced combined cardiopulmonary disease participated (median age 71, IQR 63-75 years), and 50% (5/10) were men']","['weekly coaching by a physiotherapist and an occupational therapist through video communication', 'home-based exercise program', 'Home-Based Exercise Program', 'goal-oriented, home-based exercise program, and they used a wrist-worn activity tracker to record their exercise sessions', 'Home-based cardiopulmonary telerehabilitation']","['Median adherence', 'functional improvement', 'completion and adherence rates', 'patient satisfaction; adverse events; and program efficacy in terms of change in functional capacity, level of dyspnea, and health-related quality of life', 'adherence', 'Patient-Specific Complaints Instrument scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",10.0,0.034287,"Median adherence to the exercise prescription was 75% (IQR 37%-88%), but it declined significantly when the program was divided into 2-week periods (first 2 weeks: 86%, IQR 51%-100%, and final 2 weeks: 57%, IQR 8%-75%; P=.03).","[{'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Herkert', 'Affiliation': 'Department of Cardiology, Máxima Medical Center, Eindhoven, Netherlands.'}, {'ForeName': 'Lidwien', 'Initials': 'L', 'LastName': 'Graat-Verboom', 'Affiliation': 'Department of Pulmonology, Máxima Medical Center, Eindhoven, Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gilsing-Fernhout', 'Affiliation': 'ParaMáx: Center for Paramedic Care, Máxima Medical Center, Eindhoven, Netherlands.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Schols', 'Affiliation': 'ParaMáx: Center for Paramedic Care, Máxima Medical Center, Eindhoven, Netherlands.'}, {'ForeName': 'Hareld Marijn Clemens', 'Initials': 'HMC', 'LastName': 'Kemps', 'Affiliation': 'Department of Cardiology, Máxima Medical Center, Eindhoven, Netherlands.'}]",JMIR formative research,['10.2196/28634']
2920,34751654,Mediating Effects of Stigma and Depressive Symptoms in a Social Media-Based Intervention to Improve Long-term Quality of Life Among People Living With HIV: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


Mobile health (mHealth) interventions have been shown to effectively improve the quality of life (QOL) among people living with HIV. However, little is known about the long-term effects of mHealth interventions.
OBJECTIVE


This study aims to explore the intervention mechanisms of a social media-based intervention, Run4Love, on the QOL of people with HIV over across a 9-month follow-up period.
METHODS


We recruited people living with HIV who were concurrently experiencing elevated depressive symptoms from an HIV outpatient clinic in South China. A total of 300 eligible participants were randomized either to the intervention group or the control group in a 1:1 ratio after they provided informed consent and completed a baseline survey. The intervention group received a 3-month WeChat-based intervention, comprising cognitive-behavioral stress management (CBSM) courses and physical activity promotion. The control group received a printed brochure on nutrition guidelines in addition to the usual care for HIV treatment. Neither participants nor the research staff were blinded to group assignment. All patients were followed at 3, 6, and 9 months. The primary outcome was depressive symptoms. Structural equation model (SEM) with longitudinal data was conducted to examine the sequential mediating effects of HIV-related stigma and depressive symptoms on the long-term intervention effects on participants' QOL.
RESULTS


About 91.3% (274/300), 88.3% (265/300), and 86.7% (260/300) of all participants completed follow-up surveys at 3, 6, and 9 months, respectively. Results showed that the intervention had significantly improved participants' QOL at 9 months, via complete mediating effects of reduced HIV-related stigma at 3 months and decreased depressive symptoms at 6 months. No adverse events were reported.
CONCLUSIONS


These findings underscore the critical roles of HIV-related stigma and depressive symptoms in an mHealth intervention with long-term effects on QOL improvements. We call for targeted mHealth interventions to improve QOL among people living with HIV, especially social media-based interventions that can address HIV-related stigma and alleviate depressive symptoms.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://www.chictr.org.cn/showproj.aspx?proj=21019.",2021,"No adverse events were reported.
","['people living with HIV who were concurrently experiencing elevated depressive symptoms from an HIV outpatient clinic in South China', ""participants' QOL"", 'people living with HIV', 'People Living With HIV', '300 eligible participants']","['printed brochure on nutrition guidelines in addition to the usual care for HIV treatment', '3-month WeChat-based intervention, comprising cognitive-behavioral stress management (CBSM) courses and physical activity promotion']","[""participants' QOL"", 'quality of life (QOL', 'depressive symptoms', 'Long-term Quality of Life', 'adverse events', 'QOL improvements', 'Stigma and Depressive Symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",300.0,0.0915884,"No adverse events were reported.
","[{'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Y Alicia', 'Initials': 'YA', 'LastName': 'Hong', 'Affiliation': 'Department of Health Administration and Policy, College of Health and Human Services, George Mason University, Fairfax, VA, United States.'}, {'ForeName': 'Chengbo', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'South Carolina SmartState Center for Healthcare Quality, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hanxi', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Center of AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': 'Department of Vital Statistics, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}]",Journal of medical Internet research,['10.2196/27897']
2921,34751645,Feasibility and design of a trial regarding the optimal mode of delivery for preterm birth: the CASSAVA multiple methods study.,"BACKGROUND


Around 60,000 babies are born preterm (prior to 37 weeks' gestation) each year in the UK. There is little evidence on the optimal birth mode (vaginal or caesarean section).
OBJECTIVE


The overall aim of the CASSAVA project was to determine if a trial to define the optimal mode of preterm birth could be carried out and, if so, determine what sort of trial could be conducted and how it could best be performed. We aimed to determine the specific groups of preterm women and babies for whom there are uncertainties about the best planned mode of birth, and if there would be willingness to recruit to, and participate in, a randomised trial to address some, but not all, of these uncertainties. This project was conducted in response to a Heath Technology Assessment programme commissioning call (17/22 'Mode of delivery for preterm infants').
METHODS


We conducted clinician and patient surveys ( n  = 224 and  n  = 379, respectively) to identify current practice and opinion, and a consensus survey and Delphi workshop ( n  = 76 and  n  = 22 participants, respectively) to inform the design of a hypothetical clinical trial. The protocol for this clinical trial/vignette was used in telephone interviews with clinicians ( n  = 24) and in focus groups with potential participants ( n  = 13).
RESULTS


Planned sample size and data saturation was achieved for all groups except for focus groups with participants, as this had to be curtailed because of the COVID-19 pandemic and data saturation was not achieved. There was broad agreement from parents and health-care professionals that a trial is needed. The clinician survey demonstrated a variety of practice and opinion. The parent survey suggested that women and their families generally preferred vaginal birth at later gestations and caesarean section for preterm infants. The interactive workshop and Delphi consensus process confirmed the need for more evidence (hence the case for a trial) and provided rich information on what a future trial should entail. It was agreed that any trial should address the areas with most uncertainty, including the management of women at 26-32 weeks' gestation, with either spontaneous preterm labour (cephalic presentation) or where preterm birth was medically indicated. Clear themes around the challenges inherent in conducting any trial emerged, including the concept of equipoise itself. Specific issues were as follows: different clinicians and participants would be in equipoise for each clinical scenario, effective conduct of the trial would require appropriate resources and expertise within the hospital conducting the trial, potential participants would welcome information on the trial well before the onset of labour and minority ethnic groups would require tailored approaches.
CONCLUSION


Given the lack of evidence and the variation of practice and opinion in this area, and having listened to clinicians and potential participants, we conclude that a trial should be conducted and the outlined challenges resolved.
FUTURE WORK


The CASSAVA project could be used to inform the design of a randomised trial and indicates how such a trial could be carried out. Any future trial would benefit from a pilot with qualitative input and a study within a trial to inform optimal recruitment.
LIMITATIONS


Certainty that a trial could be conducted can be determined only when it is attempted.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN12295730.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 25, No. 61. See the NIHR Journals Library website for further project information.",2021,The parent survey suggested that women and their families generally preferred vaginal birth at later gestations and caesarean section for preterm infants.,"['preterm women and babies', 'preterm birth', 'telephone interviews with clinicians ( n \u2009=\u200924) and in focus groups with potential participants ( n \u2009=\u200913']","['Heath Technology Assessment programme commissioning call', 'Delphi workshop']",['vaginal birth'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}]","[{'cui': 'C0039422', 'cui_str': 'Assessment, Technology'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",,0.323588,The parent survey suggested that women and their families generally preferred vaginal birth at later gestations and caesarean section for preterm infants.,"[{'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Norman', 'Affiliation': 'Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lawton', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Stock', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Siassakos', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Hallowell', 'Affiliation': 'Ethox Centre and Wellcome Centre for Ethics & Humanities, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sushila', 'Initials': 'S', 'LastName': 'Chowdhry', 'Affiliation': 'School of Health Sciences, University of Dundee, Dundee, UK.'}, {'ForeName': 'Ruth I', 'Initials': 'RI', 'LastName': 'Hart', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Odd', 'Affiliation': 'Division of Population Medicine, School of Medicine, University of Cardiff, Cardiff, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Brewin', 'Affiliation': ""Tommy's, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Culshaw', 'Affiliation': 'Bliss, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lee-Davey', 'Affiliation': 'Bliss, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Tebbutt', 'Affiliation': 'Edinburgh, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Whyte', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health, MRC Centre for Maternal and Fetal Health, University of Edinburgh, Edinburgh, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta25610']
2922,34751632,Working with Black vs. White patients: an experimental test of therapist decision-making in cognitive behavioral therapy for depression.,"Whether and how therapists' delivery of cognitive behavioral therapy (CBT) for depression differs by patients' ethnicity or race remains unclear. In this study, 218 therapists were randomized to clinical vignettes that involved the same text but varied in whether the accompanying image depicted a Black or White patient. Therapists exhibited three key differences in their views of clinical strategies for working with Black as compared to White patients. They viewed cognitive change strategies as less therapeutic and validation strategies as more therapeutic for Black patients. They reported similar differences for the time they would spend on each kind of strategy. When asked to compare the relative importance of cognitive change vs. validation strategies specifically, therapists rated validation as more important for Black than White patients. Among therapists presented with Black patients, positive racial attitudes were associated with viewing cognitive change and validation strategies as more therapeutic. These results suggest therapists tend to believe it is desirable to incorporate cognitive methods more limitedly when working with Black patients. Whether such adaptations enhance or detract from the care of Black patients is an important issue that merits future investigation.",2021,"When asked to compare the relative importance of cognitive change vs. validation strategies specifically, therapists rated validation as more important for Black than White patients.","['Working with Black vs. White patients', 'Black patients', '218 therapists']","['therapist decision-making in cognitive behavioral therapy', 'cognitive behavioral therapy (CBT']",['positive racial attitudes'],"[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517647', 'cui_str': '218'}]","[{'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",218.0,0.0343655,"When asked to compare the relative importance of cognitive change vs. validation strategies specifically, therapists rated validation as more important for Black than White patients.","[{'ForeName': 'Iony D', 'Initials': 'ID', 'LastName': 'Ezawa', 'Affiliation': 'Department of Psychology, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Strunk', 'Affiliation': 'Department of Psychology, The Ohio State University, Columbus, OH, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2021.1970799']
2923,34751628,Unattended compared to traditional blood pressure measurement in patients with rheumatoid arthritis: a randomised cross-over study.,"BACKGROUND


Hypertension is characterised by a high prevalence, low awareness and poor control among rheumatoid arthritis (RA) patients. Correct blood pressure (BP) measurement is highly important in these subjects. The ""unattended"" BP measurement aims to reduce the ""white-coat effect,"" a phenomenon associated with cardiovascular risk. Data on ""unattended"" BP measurement in RA and its impact on hypertensive organ damage are very limited.
METHODS


BP was measured in the same patient both traditionally (""attended"" BP) and by the ""unattended"" protocol (3 automated office BP measurements, at 1-min intervals, after 5 min of rest, with patient left alone) by a randomised cross-over design. Patients underwent clinical examination, 12-lead electrocardiography and trans-thoracic echocardiography to evaluate cardiac damage.
RESULTS


Sixty-two RA patients (mean age 67 ± 9 years, 87% women) were enrolled. Hypertension was diagnosed in 79% and 66% of patients according to ACC/AHA and ESC/ESH criteria, respectively. Concordance correlation coefficients between the two techniques were 0.55 (95%, CI 0.38-0.68) for systolic BP and 0.73 (95%, CI 0.60-0.82) for diastolic BP. ""Unattended"" (121.7/68.6 mmHg) was lower than ""attended"" BP (130.5/72.8 mmHg) for systolic and diastolic BP (both  p  < .0001). Among the two techniques, only ""unattended"" systolic BP showed a significant association with left ventricular mass ( r  = 0.11;  p  = .40 for ""attended"" BP;  r  = 0.27;  p  = .036 for unattended BP; difference between slopes:  z  = 3.92;  p  = .0001).
CONCLUSIONS


In RA patients, ""unattended"" BP is lower than traditional (""attended"") BP and more closely associated with LV mass. In these patients, the ""unattended"" automated BP measurement is a promising tool which requires further evaluation.KEY MESSAGES""Unattended"" automated blood pressure registration, aimed to reduce the ""white-coat effect"" is lower than ""attended"" value in rheumatoid arthritis patients.""Unattended"" blood pressure is more closely associated with left ventricular mass than ""attende"" registration.",2021,"Concordance correlation coefficients between the two techniques were 0.55 (95%, CI 0.38-0.68) for systolic BP and 0.73 (95%, CI 0.60-0.82) for diastolic BP. ""","['Sixty-two RA patients (mean age 67\u2009±\u20099\u2009years, 87% women) were enrolled', 'rheumatoid arthritis (RA) patients', 'patients with rheumatoid arthritis']","['traditional blood pressure measurement', '12-lead electrocardiography and trans-thoracic echocardiography']","['Correct blood pressure (BP) measurement', 'systolic BP', 'diastolic BP. ', 'Concordance correlation coefficients', 'Hypertension', 'systolic and diastolic BP', 'BP', 'unattended"" systolic BP', 'left ventricular mass']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}]",62.0,0.221397,"Concordance correlation coefficients between the two techniques were 0.55 (95%, CI 0.38-0.68) for systolic BP and 0.73 (95%, CI 0.60-0.82) for diastolic BP. ""","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bartoloni', 'Affiliation': 'Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Angeli', 'Affiliation': 'Department of Medicine and Surgery, University of Insubria and Department of Medicine and Cardiopulmonary Rehabilitation, Maugeri Care and Research Institutes, IRCCS Tradate, Varese, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Marcucci', 'Affiliation': 'Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Perricone', 'Affiliation': 'Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Cafaro', 'Affiliation': 'Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Riccini', 'Affiliation': 'Department of Cardiology, Hospital S. Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Spighi', 'Affiliation': 'Department of Cardiology, Hospital S. Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Gildoni', 'Affiliation': 'Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cavallini', 'Affiliation': 'Department of Cardiology, Hospital S. Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Verdecchia', 'Affiliation': 'Department of Cardiology, Hospital S. Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Gerli', 'Affiliation': 'Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.'}]",Annals of medicine,['10.1080/07853890.2021.1999493']
2924,34751612,Added Value of Prereading Screening Mammograms for Breast Cancer by Radiologic Technologists on Early Screening Outcomes.,"Background In the Dutch breast cancer screening program, mammograms are preread by technologists to identify possible abnormalities, leading to ""warning signals"" (an audible and visual alert if the technologist observed an abnormality suspicious for cancer) for radiologists. The best moment to present these warning signals is unknown. Purpose To determine the effect that blinding of technologists' warning signals has on radiologists' early screening outcome measures during interpretation of mammograms. Materials and Methods In this prospective study from September 2017 to May 2019, on alternating months, radiologists were either blinded or nonblinded to the warning signals of the technologist when interpreting screening mammograms for breast cancer. All discrepancies between radiologists and technologists were reviewed during quality assurance sessions every 6 weeks, which could result in secondary recalls. The outcome measures of this study were recall rate, cancer detection rate, and positive predictive value of recall. A χ 2  test was used to test for differences between the two groups. Results During the study period, 109 596 women (mean age, 62 years ± 7 [standard deviation]), including 53 291 in the blinded and 56 305 in the nonblinded groups, participated. The overall recall rate (including secondary recalls) was lower for women in the blinded group than in the nonblinded group (blinded: 1140 of 53 291 women [2.1%], nonblinded: 1372 of 56 305 women [2.4%];  P  = .001). There was no evidence of cancer detection rate differences between the groups (blinded: 349 of 53 291 women [6.5 per 1000 screening examinations], nonblinded: 360 of 56 305 women [6.4 per 1000 screening examinations];  P  = .75). The blinded group thus had a higher positive predictive value of recall (blinded: 349 of 1140 women [30.6%], nonblinded: 360 of 1372 women [26.2%];  P  = .02). Conclusion While interpreting screening mammograms for breast cancer, radiologists blinded to technologists' warning signals had lower recall rates with higher positive predictive values than nonblinded radiologists, yet cancer detection rates seemed to remain unchanged. See also the editorial by Hofvind and Lee in this issue. © RSNA, 2021.",2021,The overall recall rate (including secondary recalls) was lower for women in the blinded group than in the nonblinded group (blinded:,"['109\u2009596 women (mean age, 62 years ± 7 [standard deviation]), including 53\u2009291 in the blinded and 56\u2009305 in the nonblinded groups, participated']",[],"['overall recall rate', 'cancer detection rate differences', 'recall rate, cancer detection rate, and positive predictive value of recall']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",109596.0,0.475263,The overall recall rate (including secondary recalls) was lower for women in the blinded group than in the nonblinded group (blinded:,"[{'ForeName': 'Tanya D', 'Initials': 'TD', 'LastName': 'Geertse', 'Affiliation': 'From the Dutch Expert Centre for Screening (LRCB), Wijchenseweg 101, 6538 SW Nijmegen, the Netherlands (T.D.G., D.v.d.W., R.M.P., M.J.M.B.); Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands (W.S.P., J.N., B.K.); Department of Radiology, Amphia Hospital, Breda, the Netherlands (E.T.); Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands (R.M.P.); Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands (M.J.M.B.); and Department of Radiology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands (L.E.M.D.).'}, {'ForeName': 'Wikke', 'Initials': 'W', 'LastName': 'Setz-Pels', 'Affiliation': 'From the Dutch Expert Centre for Screening (LRCB), Wijchenseweg 101, 6538 SW Nijmegen, the Netherlands (T.D.G., D.v.d.W., R.M.P., M.J.M.B.); Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands (W.S.P., J.N., B.K.); Department of Radiology, Amphia Hospital, Breda, the Netherlands (E.T.); Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands (R.M.P.); Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands (M.J.M.B.); and Department of Radiology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands (L.E.M.D.).'}, {'ForeName': 'Daniëlle', 'Initials': 'D', 'LastName': 'van der Waal', 'Affiliation': 'From the Dutch Expert Centre for Screening (LRCB), Wijchenseweg 101, 6538 SW Nijmegen, the Netherlands (T.D.G., D.v.d.W., R.M.P., M.J.M.B.); Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands (W.S.P., J.N., B.K.); Department of Radiology, Amphia Hospital, Breda, the Netherlands (E.T.); Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands (R.M.P.); Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands (M.J.M.B.); and Department of Radiology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands (L.E.M.D.).'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Nederend', 'Affiliation': 'From the Dutch Expert Centre for Screening (LRCB), Wijchenseweg 101, 6538 SW Nijmegen, the Netherlands (T.D.G., D.v.d.W., R.M.P., M.J.M.B.); Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands (W.S.P., J.N., B.K.); Department of Radiology, Amphia Hospital, Breda, the Netherlands (E.T.); Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands (R.M.P.); Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands (M.J.M.B.); and Department of Radiology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands (L.E.M.D.).'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Korte', 'Affiliation': 'From the Dutch Expert Centre for Screening (LRCB), Wijchenseweg 101, 6538 SW Nijmegen, the Netherlands (T.D.G., D.v.d.W., R.M.P., M.J.M.B.); Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands (W.S.P., J.N., B.K.); Department of Radiology, Amphia Hospital, Breda, the Netherlands (E.T.); Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands (R.M.P.); Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands (M.J.M.B.); and Department of Radiology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands (L.E.M.D.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tetteroo', 'Affiliation': 'From the Dutch Expert Centre for Screening (LRCB), Wijchenseweg 101, 6538 SW Nijmegen, the Netherlands (T.D.G., D.v.d.W., R.M.P., M.J.M.B.); Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands (W.S.P., J.N., B.K.); Department of Radiology, Amphia Hospital, Breda, the Netherlands (E.T.); Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands (R.M.P.); Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands (M.J.M.B.); and Department of Radiology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands (L.E.M.D.).'}, {'ForeName': 'Ruud M', 'Initials': 'RM', 'LastName': 'Pijnappel', 'Affiliation': 'From the Dutch Expert Centre for Screening (LRCB), Wijchenseweg 101, 6538 SW Nijmegen, the Netherlands (T.D.G., D.v.d.W., R.M.P., M.J.M.B.); Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands (W.S.P., J.N., B.K.); Department of Radiology, Amphia Hospital, Breda, the Netherlands (E.T.); Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands (R.M.P.); Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands (M.J.M.B.); and Department of Radiology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands (L.E.M.D.).'}, {'ForeName': 'Mireille J M', 'Initials': 'MJM', 'LastName': 'Broeders', 'Affiliation': 'From the Dutch Expert Centre for Screening (LRCB), Wijchenseweg 101, 6538 SW Nijmegen, the Netherlands (T.D.G., D.v.d.W., R.M.P., M.J.M.B.); Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands (W.S.P., J.N., B.K.); Department of Radiology, Amphia Hospital, Breda, the Netherlands (E.T.); Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands (R.M.P.); Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands (M.J.M.B.); and Department of Radiology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands (L.E.M.D.).'}, {'ForeName': 'Lucien E M', 'Initials': 'LEM', 'LastName': 'Duijm', 'Affiliation': 'From the Dutch Expert Centre for Screening (LRCB), Wijchenseweg 101, 6538 SW Nijmegen, the Netherlands (T.D.G., D.v.d.W., R.M.P., M.J.M.B.); Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands (W.S.P., J.N., B.K.); Department of Radiology, Amphia Hospital, Breda, the Netherlands (E.T.); Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands (R.M.P.); Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands (M.J.M.B.); and Department of Radiology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands (L.E.M.D.).'}]",Radiology,['10.1148/radiol.2021210746']
2925,34751609,Real-life experience of treating HCV co-infection among HIV-infected population in Egypt: single-center experience.,"BACKGROUND


Liver disease has emerged as a leading cause of death among PLHIV coinfected with HCV.
METHODS


: a retrospective study involving all HCV viremic patients coinfected with HIV who presented to HCV/HIV multidisciplinary clinics located at Embaba fever hospital. Patients were assigned to receive DAAs according to the national treatment guidelines. The primary endpoint was SVR12.
RESULTS


Of the 519 patients enrolled, 38.73% LTFU; either not initiated (n=170) or did not complete the treatment (n=31). The main identified reasons behind LTFU were schedule conflict (19%) or hospitalization (13%). Among 318 patients who completed their DAAs course, Nine patients had a relapse after the end of treatment and 97% had attained SVR12. There were significant differences among different virological response groups in baseline factors including smoking (p=0.005), history of dental procedure (p= 0.007), CD4 count (p=0.007), and HIV viral load (p=<0.001). Among responders (n=309), there was a significant reduction of baseline hemoglobin and significant improvement of baseline platelets (p= 0.005) at on-treatment week 8. Baseline necro-inflammatory markers showed significant improvement across follow-up time points (p <0.001).
CONCLUSIONS


DAAs are an effective and safe choice to treat HCV in PLHIV. Social stigma could be a major cause for lacking adherence to follow-up visits.",2021,"There were significant differences among different virological response groups in baseline factors including smoking (p=0.005), history of dental procedure (p= 0.007), CD4 count (p=0.007), and HIV viral load (p=<0.001).","['519 patients enrolled, 38.73% LTFU; either not initiated (n=170) or did not complete the treatment (n=31', ' a retrospective study involving all HCV viremic patients coinfected with HIV who presented to HCV/HIV multidisciplinary clinics located at Embaba fever hospital', 'HIV-infected population in Egypt', '318 patients']",[],"['SVR12', 'relapse', 'history of dental procedure', 'baseline hemoglobin', 'CD4 count', 'HIV viral load', 'baseline platelets']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]",[],"[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}]",519.0,0.11044,"There were significant differences among different virological response groups in baseline factors including smoking (p=0.005), history of dental procedure (p= 0.007), CD4 count (p=0.007), and HIV viral load (p=<0.001).","[{'ForeName': 'Hossam', 'Initials': 'H', 'LastName': 'Abdelaziz', 'Affiliation': 'Hepatology department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Omar', 'Affiliation': 'Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Khalil', 'Affiliation': 'Infectious Disease Department, National Hepatology and Tropical Medicine Research Institute, Cairo Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Cordie', 'Affiliation': 'Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Rahma', 'Initials': 'R', 'LastName': 'Mohamed', 'Affiliation': 'Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdalla', 'Affiliation': 'Medical Research Division, National Research Center, Cairo, Egypt.'}, {'ForeName': 'Mohammed Hamdy', 'Initials': 'MH', 'LastName': 'Abdel Maksoud', 'Affiliation': 'Tropical Medicine Department, Embaba fever Hospital, Cairo, Egypt.'}, {'ForeName': 'Naeema', 'Initials': 'N', 'LastName': 'El Garhy', 'Affiliation': 'Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Lamiaa', 'Initials': 'L', 'LastName': 'Ali', 'Affiliation': 'Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'El Serafy', 'Affiliation': 'Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Esmat', 'Affiliation': 'Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Wahid', 'Initials': 'W', 'LastName': 'Doss', 'Affiliation': 'Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Egypt.'}]",Expert review of anti-infective therapy,['10.1080/14787210.2022.2004117']
2926,34751605,Information and communication technology to improve school participation among upper secondary school students with special educational needs.,"BACKGROUND


Evidence-based information and communication technology (ICT) interventions to enhance school participation among students with special educational needs (SEN) are required.
AIM


To evaluate the impact of an ICT intervention on school participation among upper secondary school students with special educational needs.
MATERIALS AND METHODS


Data on 300 students' assessments with the School Setting Interview (SSI), grades and school attendance were used in this quasi-experimental study, with a one-group pretest-posttest design. Descriptive and inferential statistics and effect size were used, as well as Rasch analysis to generate interval data on the students' ordinal SSI ratings.
RESULTS


In the ICT intervention (median time eight hours), 54% of the students received a tablet, and software concerned with planning and structure was received by 85%. After the ICT intervention, a significant decrease in perceived need for adjustments in school activities was found on a group level and 30% of the students improved their school attendance. Students who benefitted the most from the ICT intervention had few adjustment needs in school activities and no special educational support at baseline.
CONCLUSION


An ICT intervention is promising for improving school participation among upper secondary school students with SEN.",2021,"After the ICT intervention, a significant decrease in perceived need for adjustments in school activities was found on a group level and 30% of the students improved their school attendance.","['upper secondary school students with special educational needs', 'Students who benefitted the most from the', ""Data on 300 students' assessments with the School Setting Interview (SSI), grades and school attendance were used in this quasi-experimental study, with a one-group pretest-posttest design"", 'school participation among upper secondary school students with special educational needs', 'upper secondary school students with SEN', 'students with special educational needs (SEN']","['communication technology (ICT) interventions', 'ICT intervention']","['perceived need for adjustments in school activities', 'school activities', 'school attendance']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",300.0,0.0499343,"After the ICT intervention, a significant decrease in perceived need for adjustments in school activities was found on a group level and 30% of the students improved their school attendance.","[{'ForeName': 'Moa', 'Initials': 'M', 'LastName': 'Yngve', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Ekbladh', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Lidström', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hemmingsson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}]",Scandinavian journal of occupational therapy,['10.1080/11038128.2021.1998610']
2927,34751757,Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial.,"Importance


The optimal management for acute traumatic cervical spinal cord injury (SCI) is unknown.
Objective


To determine whether early surgical decompression results in better motor recovery than delayed surgical treatment in patients with acute traumatic incomplete cervical SCI associated with preexisting canal stenosis but without bone injury.
Design, Setting, and Participants


This multicenter randomized clinical trial was conducted in 43 tertiary referral centers in Japan from December 2011 through November 2019. Patients aged 20 to 79 years with motor-incomplete cervical SCI with preexisting canal stenosis (American Spinal Injury Association [ASIA] Impairment Scale C; without fracture or dislocation) were included. Data were analyzed from September to November 2020.
Interventions


Patients were randomized to undergo surgical treatment within 24 hours after admission or delayed surgical treatment after at least 2 weeks of conservative treatment.
Main Outcomes and Measures


The primary end points were improvement in the mean ASIA motor score, total score of the spinal cord independence measure, and the proportion of patients able to walk independently at 1 year after injury.
Results


Among 72 randomized patients, 70 patients (mean [SD] age, 65.1 [9.4] years; age range, 41-79 years; 5 [7%] women and 65 [93%] men) were included in the full analysis population (37 patients assigned to early surgical treatment and 33 patients assigned to delayed surgical treatment). Of these, 56 patients (80%) had data available for at least 1 primary outcome at 1 year. There was no significant difference among primary end points for the early surgical treatment group compared with the delayed surgical treatment group (mean [SD] change in ASIA motor score, 53.7 [14.7] vs 48.5 [19.1]; difference, 5.2; 95% CI, -4.2 to 14.5; P = .27; mean [SD] SCIM total score, 77.9 [22.7] vs 71.3 [27.3]; P = .34; able to walk independently, 21 of 30 patients [70.0%] vs 16 of 26 patients [61.5%]; P = .51). A mixed-design analysis of variance revealed a significant difference in the mean change in ASIA motor scores between the groups (F1,49 = 4.80; P = .03). The early surgical treatment group, compared with the delayed surgical treatment group, had greater motor scores than the delayed surgical treatment group at 2 weeks (mean [SD] score, 34.2 [18.8] vs 18.9 [20.9]), 3 months (mean [SD] score, 49.1 [15.1] vs 37.2 [20.9]), and 6 months (mean [SD] score, 51.5 [13.9] vs 41.3 [23.4]) after injury. Adverse events were common in both groups (eg, worsening of paralysis, 6 patients vs 6 patients; death, 3 patients vs 3 patients).
Conclusions and Relevance


These findings suggest that among patients with cervical SCI, early surgical treatment produced similar motor regain at 1 year after injury as delayed surgical treatment but showed accelerated recovery within the first 6 months. These exploratory results suggest that early surgical treatment leads to faster neurological recovery, which requires further validation.
Trial Registration


ClinicalTrials.gov Identifier: NCT01485458; umin.ac.jp/ctr Identifier: UMIN000006780.",2021,"The early surgical treatment group, compared with the delayed surgical treatment group, had greater motor scores than the delayed surgical treatment group at 2 weeks (mean [SD] score, 34.2 [18.8] vs 18.9 [20.9]), 3 months (mean [SD] score, 49.1 [15.1] vs 37.2 [20.9]), and 6 months (mean [SD] score, 51.5 [13.9] vs 41.3 [23.4]) after injury.","['patients with acute traumatic incomplete cervical SCI associated with preexisting canal stenosis but without bone injury', 'Incomplete Cervical Spinal Cord Injury', '43 tertiary referral centers in Japan from December 2011 through November 2019', 'Patients aged 20 to 79 years with motor-incomplete cervical SCI with preexisting canal stenosis (American Spinal Injury Association [ASIA', 'acute traumatic cervical spinal cord injury (SCI', '72 randomized patients, 70 patients (mean [SD] age, 65.1 [9.4] years; age range, 41-79 years; 5 [7%] women and 65 [93%] men) were included in the full analysis population (37 patients assigned to early surgical treatment and 33 patients assigned to delayed surgical treatment']",['Early vs Delayed Surgical Treatment'],"['mean ASIA motor score, total score of the spinal cord independence measure, and the proportion of patients able to walk independently at 1 year after injury', 'mean change in ASIA motor scores', 'Adverse events', 'Motor Recovery', 'greater motor scores', 'motor regain', 'ASIA motor score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0561852', 'cui_str': 'Bone injury'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037937', 'cui_str': 'Spinal injury'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",72.0,0.306971,"The early surgical treatment group, compared with the delayed surgical treatment group, had greater motor scores than the delayed surgical treatment group at 2 weeks (mean [SD] score, 34.2 [18.8] vs 18.9 [20.9]), 3 months (mean [SD] score, 49.1 [15.1] vs 37.2 [20.9]), and 6 months (mean [SD] score, 51.5 [13.9] vs 41.3 [23.4]) after injury.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Chikuda', 'Affiliation': 'Department of Orthopaedic Surgery, Gunma University, Maebashi, Gunma, Japan.'}, {'ForeName': 'Yurie', 'Initials': 'Y', 'LastName': 'Koyama', 'Affiliation': 'Kitasato University School of Nursing, Sagamihara, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Matsubayashi', 'Affiliation': 'Department of Orthopaedic Surgery, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Ogata', 'Affiliation': 'Department of Rehabilitation Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ohtsu', 'Affiliation': 'National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Shurei', 'Initials': 'S', 'LastName': 'Sugita', 'Affiliation': 'Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Sumitani', 'Affiliation': 'Department of Pain and Palliative Medicine, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuho', 'Initials': 'Y', 'LastName': 'Kadono', 'Affiliation': 'Saitama Medical University, Moroyama, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Miura', 'Affiliation': 'JR Tokyo General Hospital, Tokyo, Japan.'}, {'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopaedic Surgery, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Akiyama', 'Affiliation': 'Saitama Medical Center, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Anno', 'Affiliation': 'Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Azuma', 'Affiliation': 'Japanese Red Cross Saitama Hospital, Saitama, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Endo', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Endo', 'Affiliation': 'Wakayama Medical University Hospital, Wakayama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Fujiyoshi', 'Affiliation': 'Kimitsu Chuo Hospital, Kisarazu, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Furuya', 'Affiliation': 'Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Tonami General Hospital, Tonami, Japan.'}, {'ForeName': 'Akiro', 'Initials': 'A', 'LastName': 'Higashikawa', 'Affiliation': 'Kanto Rosai Hospital, Kawasaki, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Hiyama', 'Affiliation': 'Tokai University Hospital, Isehara, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Horii', 'Affiliation': 'Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Iimoto', 'Affiliation': 'Hokkaido Spinal Cord Injury Center, Bibai, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Iizuka', 'Affiliation': 'Department of Orthopaedic Surgery, Gunma University, Maebashi, Gunma, Japan.'}, {'ForeName': 'Hisanori', 'Initials': 'H', 'LastName': 'Ikuma', 'Affiliation': 'Kagawa Prefectural Central Hospital, Takamatsu, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Imagama', 'Affiliation': 'Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Inokuchi', 'Affiliation': 'Saitama Medical University Saitama Medical Center, Kawagoe, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Inoue', 'Affiliation': 'Jichi Medical University Hospital, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Tomoo', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Kagawa Prefectural Central Hospital, Takamatsu, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ishii', 'Affiliation': 'Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Ishii', 'Affiliation': 'Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Takui', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Niigata City General Hospital, Niigata, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Itoi', 'Affiliation': 'Juntendo University Shizuoka Hospital, Izunokuni, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Iwamoto', 'Affiliation': 'Kagawa Prefectural Central Hospital, Takamatsu, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Iwasaki', 'Affiliation': 'Osaka Rosai Hospital, Sakai, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kaito', 'Affiliation': 'Osaka University Hospital, Suita, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Tokyo Medical and Dental University Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Katoh', 'Affiliation': 'Tokai University Hospital, Isehara, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Kawaguchi', 'Affiliation': 'Toyama University Hospital, Toyama, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kawano', 'Affiliation': 'Spinal Injuries Center, Iizuka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Jichi Medical University Hospital, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Koda', 'Affiliation': 'Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Komatsu', 'Affiliation': 'Hokkaido Spinal Cord Injury Center, Bibai, Japan.'}, {'ForeName': 'Gentaro', 'Initials': 'G', 'LastName': 'Kumagai', 'Affiliation': 'Hirosaki University Hospital, Hirosaki, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Spinal Injuries Center, Iizuka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Osaka University Hospital, Suita, Japan.'}, {'ForeName': 'Chikato', 'Initials': 'C', 'LastName': 'Mannoji', 'Affiliation': 'Chiba Aoba Municipal Hospital, Chiba, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Masuda', 'Affiliation': 'Tokyo Metropolitan Tama Medical Center, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Masuda', 'Affiliation': 'Nara Medical University Hospital, Kashihara, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Nihon University Itabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Matsunaga', 'Affiliation': 'Imakiire General Hospital, Kagoshima, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Hamamatsu University Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Tokue', 'Initials': 'T', 'LastName': 'Mieda', 'Affiliation': 'Department of Orthopaedic Surgery, Gunma University, Maebashi, Gunma, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Miyoshi', 'Affiliation': 'Yokohama Rosai Hospital, Yokohama, Japan.'}, {'ForeName': 'Joji', 'Initials': 'J', 'LastName': 'Mochida', 'Affiliation': 'Tokai University Hospital, Isehara, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Moridaira', 'Affiliation': 'Dokkyo Medical University Hospital, Mibu, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Motegi', 'Affiliation': 'Chiba Aoba Municipal Hospital, Chiba, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Wakayama Medical University Hospital, Wakayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Nohara', 'Affiliation': 'Dokkyo Medical University Hospital, Mibu, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Oae', 'Affiliation': 'Saitama Medical University Saitama Medical Center, Kawagoe, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ogawa', 'Affiliation': 'Sendai Medical Center, Sendai, Japan.'}, {'ForeName': 'Rentaro', 'Initials': 'R', 'LastName': 'Okazaki', 'Affiliation': 'Japanese Red Cross Saitama Hospital, Saitama, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Okuda', 'Affiliation': 'Nara Medical University Hospital, Kashihara, Japan.'}, {'ForeName': 'Eijiro', 'Initials': 'E', 'LastName': 'Onishi', 'Affiliation': 'Kurashiki Central Hospital, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ono', 'Affiliation': 'Hirosaki University Hospital, Hirosaki, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Oshima', 'Affiliation': 'Nihon University Itabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Oshita', 'Affiliation': 'Showa University Northern Yokohama Hospital, Yokohama, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Saita', 'Affiliation': 'Saitama Medical Center, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Sasao', 'Affiliation': 'St Marianna University Hospital, Kawasaki, Japan.'}, {'ForeName': 'Kimiaki', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Sawakami', 'Affiliation': 'Niigata City General Hospital, Niigata, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Seichi', 'Affiliation': 'Department of Orthopaedic Surgery, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Seki', 'Affiliation': 'Toyama University Hospital, Toyama, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Shigematsu', 'Affiliation': 'Nara Medical University Hospital, Kashihara, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Suda', 'Affiliation': 'Hokkaido Spinal Cord Injury Center, Bibai, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Takagi', 'Affiliation': 'Tonami General Hospital, Tonami, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Kyorin University Hospital, Tokyo, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Takahashi', 'Affiliation': 'Juntendo University Shizuoka Hospital, Izunokuni, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Takasawa', 'Affiliation': 'Department of Orthopaedic Surgery, Gunma University, Maebashi, Gunma, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Takenaka', 'Affiliation': 'Osaka University Hospital, Suita, Japan.'}, {'ForeName': 'Katsushi', 'Initials': 'K', 'LastName': 'Takeshita', 'Affiliation': 'Jichi Medical University Hospital, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Takeshita', 'Affiliation': 'Yokohama Rosai Hospital, Yokohama, Japan.'}, {'ForeName': 'Takamitsu', 'Initials': 'T', 'LastName': 'Tokioka', 'Affiliation': 'Kochi Health Sciences Center, Kochi, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Tokuhashi', 'Affiliation': 'Nihon University Itabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Juichi', 'Initials': 'J', 'LastName': 'Tonosu', 'Affiliation': 'Kanto Rosai Hospital, Kawasaki, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Uei', 'Affiliation': 'Nihon University Itabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Kanichiro', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Hirosaki University Hospital, Hirosaki, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Tokai University Hospital, Isehara, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Yahata', 'Affiliation': 'Saitama Medical University Saitama Medical Center, Kawagoe, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': 'Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Taketoshi', 'Initials': 'T', 'LastName': 'Yasuda', 'Affiliation': 'Toyama University Hospital, Toyama, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Yasui', 'Affiliation': 'Hokkaido Spinal Cord Injury Center, Bibai, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Yoshii', 'Affiliation': 'Tokyo Medical and Dental University Hospital, Tokyo, Japan.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.33604']
2928,34751730,Pfizer Launches Phase 1 mRNA Flu Vaccine Trial.,,2021,,[],[],[],[],[],[],,0.171095,,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Abbasi', 'Affiliation': ''}]",JAMA,['10.1001/jama.2021.19634']
2929,34751680,"Retraction: Samaha et al. Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon.  Viruses  2021,  13 , 989.","The journal retracts the article, Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon [...].",2021,"The journal retracts the article, Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon [...].",['Asymptomatic SARS-CoV-2 Infected Subjects'],['Ivermectin'],[],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}]",[],,0.182179,"The journal retracts the article, Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon [...].","[{'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'Samaha', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Mouawia', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Fawaz', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Beirut Arab University, Beirut, Mazraa 1105, Lebanon.'}, {'ForeName': 'Hamad', 'Initials': 'H', 'LastName': 'Hassan', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Salami', 'Affiliation': 'Department of Mathematics, Faculty of Sciences, Lebanese University, Nabatieh 1700, Lebanon.'}, {'ForeName': 'Ali Al', 'Initials': 'AA', 'LastName': 'Bazzal', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Hamid Bou', 'Initials': 'HB', 'LastName': 'Saab', 'Affiliation': 'Faculty of Sciences, Lebanese University, Zahle 1801, Lebanon.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Al-Wakeel', 'Affiliation': 'Karbala Health Directory, Baghdad 10081, Iraq.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alsaabi', 'Affiliation': 'Department of Biology, Lille University, 59160 Lille, France.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Chouman', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Mahmoud Al', 'Initials': 'MA', 'LastName': 'Moussawi', 'Affiliation': 'Faculty of Nursing Sciences, Islamic University of Lebanon, Baalbek 1800, Lebanon.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Ayoub', 'Affiliation': 'Department of Cardiology, Rayak University Hospital, Bekaa 1801, Lebanon.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Raad', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Hajjeh', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Ali H', 'Initials': 'AH', 'LastName': 'Eid', 'Affiliation': 'Department of Basic Medical Sciences, College of Medicine, QU Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Houssam', 'Initials': 'H', 'LastName': 'Raad', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut, Lebanon.'}]",Viruses,['10.3390/v13112154']
2930,34751666,"An In Situ, Child-Led Intervention to Promote Emotion Regulation Competence in Middle Childhood: Protocol for an Exploratory Randomized Controlled Trial.","BACKGROUND


Emotion regulation is a key transdiagnostic risk factor for a range of psychopathologies, making it a prime target for both prevention and treatment interventions in childhood. Existing interventions predominantly rely on workshops or in-person therapy-based approaches, limiting the ability to promote emotion regulation competence for children in everyday settings and at scale. Purrble is a newly developed, inexpensive, socially assistive robot-in the form of an interactive plush toy-that uses haptic feedback to support in-the-moment emotion regulation. It is accessible to children as needed in their daily lives, without the need for a priori training. Although qualitative data from previous studies show high engagement in situ and anecdotal evidence of the robot being incorporated into children's emotion regulation routines, there is no quantitative evidence of the intervention's impact on child outcomes.
OBJECTIVE


The aim of this study is to examine the efficacy of a new intervention model for child-led emotion regulation-Purrble-that can be deployed across prevention and treatment contexts.
METHODS


Overall, 134 children aged 8 to 10 years will be selected from an enriched nonclinical North American population; for inclusion, the cutoff for the parents' rating of child dysregulation will be ≥10 points in the total difficulties score on the Strengths and Difficulties Questionnaire. This cutoff was selected to obtain a measurable, but not necessarily clinical, level of the child's emotion regulatory difficulties. The selected families will be randomly assigned with .5 probability to receive either a Purrble or an active control (noninteractive plush toy). The primary outcome will be a daily ecological momentary assessment measure of child emotion regulation capability (as reported by parents) over a period of 4 weeks. Exploratory analyses will investigate the intervention impact on secondary outcomes of child emotion regulation, collected weekly over the same 4-week period, with follow-ups at 1 month and 6 months postdeployment. Quantitative data will be analyzed on an intent-to-treat basis. A proportion of families (approximately 30% of the sample) will be interviewed after deployment as part of the process analysis.
RESULTS


The study is funded by the UKRI Future Leaders Fellowship (MR/T041897/1) and an in-kind contribution from the Committee for Children. This study received ethical approval from the Pearl institutional review board (#18-CFC-101). Participant recruitment started in February 2021, with the 1-month deployment in April-May 2021. The results of this analysis will be published in 2022.
CONCLUSIONS


This study will be the first quantitative evaluation of the efficacy of an innovative, proof-of-concept intervention model for an in situ, child-led emotion regulation intervention. Insights into the trajectory of daily changes, complemented with weekly questionnaire batteries and postdeployment interviews, will result in an in-depth understanding of whether and how the hypothesized intervention logic model works, leading to further intervention optimization.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04810455; http://clinicaltrials.gov/ct2/show/NCT04810455.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/28914.",2021,The aim of this study is to examine the efficacy of a new intervention model for child-led emotion regulation,"['child-led emotion regulation', 'Middle Childhood', '134 children aged 8 to 10 years will be selected from an enriched nonclinical North American population']",['Purrble or an active control (noninteractive plush toy'],['daily ecological momentary assessment measure of child emotion regulation capability'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040565', 'cui_str': 'Toy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",134.0,0.153139,The aim of this study is to examine the efficacy of a new intervention model for child-led emotion regulation,"[{'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Slovak', 'Affiliation': ""Department of Informatics, King's College London, London, United Kingdom.""}, {'ForeName': 'Brett Q', 'Initials': 'BQ', 'LastName': 'Ford', 'Affiliation': 'Psychology Department, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Widen', 'Affiliation': 'Committee for Children, Seattle, WA, United States.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Daudén Roquet', 'Affiliation': ""Department of Informatics, King's College London, London, United Kingdom.""}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Theofanopoulou', 'Affiliation': ""Department of Informatics, King's College London, London, United Kingdom.""}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Gross', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hankin', 'Affiliation': 'Department of Psychology, University of Illinois Urbana Champaign, Champaign, IL, United States.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Klasnja', 'Affiliation': 'School of Information, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR research protocols,['10.2196/28914']
2931,34751665,A Text Message Intervention for Adolescents With Depression and Their Parents or Caregivers to Overcome Cognitive Barriers to Mental Health Treatment Initiation: Focus Groups and Pilot Trial.,"BACKGROUND


Many adolescents with depression do not pursue mental health treatment following a health care provider referral. We developed a theory-based automated SMS text message intervention (Text to Connect [T2C]) that attempts to reduce cognitive barriers to the initiation of mental health care.
OBJECTIVE


In this two-phase study, we seek to first understand the potential of T2C and then test its engagement, usability, and potential efficacy among adolescents with depression and their parents or caregivers.
METHODS


In phase 1, we conducted focus groups with adolescents with depression (n=9) and their parents or caregivers (n=9) separately, and transcripts were examined to determine themes. In phase 2, we conducted an open trial of T2C comprising adolescents with depression referred to mental health care (n=43) and their parents or caregivers (n=28). We assessed usability by examining program engagement, usability ratings, and qualitative feedback at the 4-week follow-up. We also assessed potential effectiveness by examining changes in perceived barriers to treatment and mental health care initiation from baseline to 4 weeks.
RESULTS


In phase 1, we found that the themes supported the T2C approach. In phase 2, we observed high engagement with daily negative affect check-ins, high usability ratings, and decreased self-reported barriers to mental health treatment over time among adolescents. Overall, 52% (22/42) of the adolescents who completed follow-up reported that they had attended an appointment with a mental health care specialist. Of the 20 adolescents who had not attended a mental health care appointment, 5% (1/20) reported that it was scheduled for a future date, 10% (2/20) reported that the primary care site did not have the ability to help them schedule a mental health care appointment, and 15% (3/20) reported that they were no longer interested in receiving mental health care.
CONCLUSIONS


The findings from this study suggest that T2C is acceptable to adolescents with depression and most parents or caregivers; it is used at high rates; and it may be helpful to reduce cognitive barriers to mental health care initiation.",2021,"In phase 2, we observed high engagement with daily negative affect check-ins, high usability ratings, and decreased self-reported barriers to mental health treatment over time among adolescents.","['Adolescents With Depression and Their Parents or Caregivers', '20 adolescents who had not attended a mental health care appointment, 5% (1/20) reported that it was scheduled for a future date, 10% (2/20) reported that the primary care site did not have the ability to help them schedule a mental health care appointment, and 15% (3/20) reported that they were no longer interested in receiving mental health care', 'comprising adolescents with depression referred to mental health care (n=43) and their parents or caregivers (n=28', 'groups with adolescents with depression (n=9) and their parents or caregivers (n=9) separately, and transcripts', 'adolescents with depression and their parents or caregivers', 'adolescents with depression do not pursue mental health treatment following a health care provider referral', 'adolescents with depression and most parents or caregivers']","['Text Message Intervention', 'T2C', 'theory-based automated SMS text message intervention (Text to Connect [T2C']","['usability ratings, and qualitative feedback']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0559294', 'cui_str': 'Did not attend'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0475389', 'cui_str': 'Tumor stage T2c'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.0548007,"In phase 2, we observed high engagement with daily negative affect check-ins, high usability ratings, and decreased self-reported barriers to mental health treatment over time among adolescents.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brent', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, United States.'}]",JMIR formative research,['10.2196/30580']
2932,34765900,Inpatient compliance with venous thromboembolism prophylaxis after orthopaedic trauma: results from a randomized controlled trial of aspirin versus low molecular weight heparin.,"Objectives


To compare inpatient compliance with venous thromboembolism prophylaxis regimens.
Design


A secondary analysis of patients enrolled in the ADAPT (A Different Approach to Preventing Thrombosis) randomized controlled trial.
Setting


Level I trauma center.
Patients/Participants


Patients with operative extremity or any pelvic or acetabular fracture requiring venous thromboembolism prophylaxis.
Intervention


We compared patients randomized to receive either low molecular weight heparin (LMWH) 30 mg or aspirin 81 mg BID during their inpatient admission.
Main Outcome Measurements


The primary outcome measure was the number of doses missed compared with prescribed number of doses.
Results


A total of 329 patients were randomized to receive either LMWH 30 mg BID (164 patients) or aspirin 81 mg BID (165 patients). No differences observed in percentage of patients who missed a dose (aspirin: 41.2% vs LMWH: 43.3%,  P  = .7) or mean number of missed doses (0.6 vs 0.7 doses,  P  = .4). The majority of patients (57.8%, n = 190) did not miss any doses. Missed doses were often associated with an operation.
Conclusions


These data should reassure clinicians that inpatient compliance is similar for low molecular weight heparin and aspirin regimens.",2021,"No differences observed in percentage of patients who missed a dose (aspirin: 41.2% vs LMWH: 43.3%,  P  = .7) or mean number of missed doses (0.6 vs 0.7 doses,  P  = .4).","['Inpatient compliance with venous thromboembolism prophylaxis after orthopaedic trauma', 'Patients/Participants\n\n\nPatients with operative extremity or any pelvic or acetabular fracture requiring venous thromboembolism prophylaxis', '329 patients']","['aspirin 81\u200amg BID', 'aspirin', 'low molecular weight heparin (LMWH) 30\u200amg or aspirin', 'LMWH 30\u200amg BID']",['number of doses missed compared with prescribed number of doses'],"[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0199242', 'cui_str': 'Anticoagulant prophylaxis'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0347804', 'cui_str': 'Fracture of acetabulum'}]","[{'cui': 'C0983882', 'cui_str': 'Aspirin 81 MG'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}]",329.0,0.185919,"No differences observed in percentage of patients who missed a dose (aspirin: 41.2% vs LMWH: 43.3%,  P  = .7) or mean number of missed doses (0.6 vs 0.7 doses,  P  = .4).","[{'ForeName': 'Bryce E', 'Initials': 'BE', 'LastName': 'Haac', 'Affiliation': 'R Adams Cowley Shock Trauma Center, Department of Surgery.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': ""O'Hara"", 'Affiliation': 'R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine.'}, {'ForeName': 'Theodore T', 'Initials': 'TT', 'LastName': 'Manson', 'Affiliation': 'R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine.'}, {'ForeName': 'Renan C', 'Initials': 'RC', 'LastName': 'Castillo', 'Affiliation': 'Department of Health Policy and Management, Center for Health Services and Outcomes Research and Johns Hopkins Center for Injury and Research Policy, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': ""O'Toole"", 'Affiliation': 'R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Stein', 'Affiliation': 'R Adams Cowley Shock Trauma Center, Department of Surgery.'}]",OTA international : the open access journal of orthopaedic trauma,['10.1097/OI9.0000000000000150']
2933,34765854,The Proteomic Signature of Recombinant Growth Hormone in Recreational Athletes.,"Objective


Administration of human growth hormone (hGH) is prohibited in competitive sport and its detection in an athlete's sample triggers an adverse analytical finding. However, the biological processes that are modulated by recombinant hGH are not well characterized and associated blood serum proteins may constitute new biomarkers for hGH misuse.
Methods


Thirty-five recreational athletes were enrolled in a study to investigate the time- and dose-dependent response of serum protein levels to recombinant hGH administration. Participants were randomly assigned to 4 groups, receiving 1 of 3 different doses of recombinant hGH or a placebo. Bio samples were collected at 22 time points over a period of 13 weeks, starting 4 weeks before treatment, during 3 weeks of treatment, and at 6 weeks' follow-up. A total of 749 serum samples were analyzed for 1305 protein markers using the SOMAscan proteomics platform.
Results


We identified 66 proteins that significantly associated with recombinant hGH administration and dosage, including well known hGH targets, such as IGF1, but also previously unknown hGH-related proteins (eg, protease inhibitors, WFIKKN1, and chemokines, CCL2). Network analysis revealed changes in specific biological pathways, mainly related to the immune system and glucose metabolism.
Conclusion


Our analysis suggests that hGH administration affects biological processes more strongly than previously acknowledged. Some of the proteins were dysregulated even after hGH treatment and could potentially be developed into biomarkers for hGH misuse. Moreover, our findings suggest new roles for hGH-associated proteins in the etiology of hGH-related diseases and may indicate new risks that may be associated with hGH misuse.",2021,"Network analysis revealed changes in specific biological pathways, mainly related to the immune system and glucose metabolism.
","['A total of 749 serum samples were analyzed for 1305 protein markers using the SOMAscan proteomics platform', 'Methods\n\n\nThirty-five recreational athletes', 'Recreational Athletes']","['human growth hormone (hGH', 'hGH', 'recombinant hGH or a placebo']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0872252', 'cui_str': 'Proteomics'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],35.0,0.109476,"Network analysis revealed changes in specific biological pathways, mainly related to the immune system and glucose metabolism.
","[{'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Esefeld', 'Affiliation': 'Proteomics Core, Weill Cornell Medicine-Qatar, Qatar Foundation-Education City, Doha, Qatar.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Pastor', 'Affiliation': 'Integrative Pharmacology and Systems Neuroscience Research Group. Hospital del Mar Medical Research Institute (IMIM), 08009 Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Torre', 'Affiliation': 'Integrative Pharmacology and Systems Neuroscience Research Group. Hospital del Mar Medical Research Institute (IMIM), 08009 Barcelona, Spain.'}, {'ForeName': 'Osquel', 'Initials': 'O', 'LastName': 'Barroso', 'Affiliation': 'World Anti-Doping Agency, Montreal, Quebec H4Z 1B7, Canada.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Aikin', 'Affiliation': 'World Anti-Doping Agency, Montreal, Quebec H4Z 1B7, Canada.'}, {'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Sarwath', 'Affiliation': 'Proteomics Core, Weill Cornell Medicine-Qatar, Qatar Foundation-Education City, Doha, Qatar.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Engelke', 'Affiliation': 'Proteomics Core, Weill Cornell Medicine-Qatar, Qatar Foundation-Education City, Doha, Qatar.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schmidt', 'Affiliation': 'Proteomics Core, Weill Cornell Medicine-Qatar, Qatar Foundation-Education City, Doha, Qatar.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Suhre', 'Affiliation': 'Bioinformatics Core, Weill Cornell Medicine-Qatar, Qatar Foundation-Education City, Doha, Qatar.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvab156']
2934,34765814,The Effect of Meibomian Gland Dysfunction Treatment on Sleep Quality.,"Purpose


To assess the therapeutic efficacy of a combinational therapy, including conventional treatment and intense pulsed light (IPL) technique on sleep quality of patients with meibomian gland dysfunction (MGD).
Methods


Fifty participants with a clinical diagnosis of MGD were enrolled in this study. Participants underwent three sessions of IPL therapy. There was a 2-week interval between IPL sessions 1 and 2 and 1 month between sessions 2 and 3. Treatment was supplemented with conventional home-based therapy (including lid hygiene, warm compress, eyelid massage, and lid margin scrub) for MGD. Dry eye symptomatology, tear film, and ocular surface parameters were evaluated at baseline (day 0) and days 15, 45, and 75. Sleep quality was assessed before and after the study using Pittsburgh Sleep Quality Index (PSQI).
Results


PSQI components improved significantly at day 75 in comparison with the baseline (all  P  < 0.05). Ocular Surface Disease Index (OSDI) score, noninvasive Keratograph tear break-up time (NIKBUT), fluorescein tear break-up time (FTBUT), meibomian gland expressibility, meibum quality score, and tear osmolarity improved at follow-up visits ( P  < 0.05). Younger patients showed more improvement in NIKBUT, sleep quality, and duration ( P  = 0.024,  P  = 0.047, and  P  = 0.008). Sleep latency decreased with increased NIKBUT and FTBUT and decreased OSDI score ( P  = 0.001,  P  = 0.005, and  P  = 0.041).
Conclusions


The treatment of MGD is effective for improving sleep quality. Younger patients may preferentially benefit from the treatment.",2021,"Younger patients showed more improvement in NIKBUT, sleep quality, and duration ( P  = 0.024,  P  = 0.047, and  P  = 0.008).","['Fifty participants with a clinical diagnosis of MGD', 'patients with meibomian gland dysfunction (MGD', 'Younger patients']","['combinational therapy', 'MGD', 'Meibomian Gland Dysfunction', 'conventional treatment and intense pulsed light (IPL) technique', 'conventional home-based therapy (including lid hygiene, warm compress, eyelid massage, and lid margin scrub) for MGD', 'IPL therapy']","['Sleep quality', 'Ocular Surface Disease Index (OSDI) score, noninvasive Keratograph tear break-up time (NIKBUT), fluorescein tear break-up time (FTBUT), meibomian gland expressibility, meibum quality score, and tear osmolarity', 'Sleep latency', 'Pittsburgh Sleep Quality Index (PSQI', 'sleep quality', 'Sleep Quality', 'PSQI components', 'therapeutic efficacy', 'OSDI score', 'improvement in NIKBUT, sleep quality, and duration', 'Dry eye symptomatology, tear film, and ocular surface parameters']","[{'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0332260', 'cui_str': 'Compressing'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C5197842', 'cui_str': 'Meibomian Lipids'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",50.0,0.0434627,"Younger patients showed more improvement in NIKBUT, sleep quality, and duration ( P  = 0.024,  P  = 0.047, and  P  = 0.008).","[{'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Zarei-Ghanavati', 'Affiliation': 'Eye Research Center, Department of Ophthalmology, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Hassanzadeh', 'Affiliation': 'Department of Optometry, Paramedical College, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Abbas Azimi', 'Initials': 'AA', 'LastName': 'Khorasani', 'Affiliation': 'Refractive Error Research Center, Paramedical College, Department of Optometry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Asieh', 'Initials': 'A', 'LastName': 'Ehsaei', 'Affiliation': 'Refractive Error Research Center, Paramedical College, Department of Optometry, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of current ophthalmology,['10.4103/joco.joco_171_20']
2935,34765813,Anterior Subconjunctival Anesthesia for Manual Small Incision Cataract Surgery: A Randomized Controlled Trial.,"Purpose


To compare the effectiveness of anterior subconjunctival anesthesia (ASCA) with sub-tenon's anesthesia (STA) for manual small incision cataract surgery (MSICS), regarding pain, akinesia, surgeon comfort, and complications.
Methods


This trial randomized 164 patients into two groups. Group 1 received ASCA, and Group 2 received STA. MSICS was performed on all patients. Any complications of anesthesia were noted before starting surgery. Patient ocular motility during surgery was scored between 0 and 4 based on the number of directions of gaze in which movement persisted. Following surgery, patients scored pain felt during surgery on a visual pain-score analog, and the surgeon graded for ""discomfort"" felt during surgery from 0 (Nil) to 4 (additional anesthesia needed).
Results


Chemosis due to anesthesia and persistence of ocular motility in all four gaze directions were seen in all 82 patients of Group 1, but these did not prevent the surgeon from performing MSICS. Seventy-seven patients (94%) in Group 1 and 79 (96.4%) in Group 2 had no or mild pain during surgery. The surgeon had moderate-to-severe discomfort in 14 (17.2%) Group 1 patients and 3 (3.6%) Group 2 patients, most of whom had deep-set eyes or exhibited excessive eye movements. Two patients in Group 1 and one patient in Group 2 were converted to peribulbar block.
Conclusion


ASCA is a safe and effective alternative for performing MSICS. It does not induce akinesia but provides adequate anesthesia for the surgery in most patients, except those with deep-set eyes, especially if displaying increased anxiety.",2021,"Results


Chemosis due to anesthesia and persistence of ocular motility in all four gaze directions were seen in all 82 patients of Group 1, but these did not prevent the surgeon from performing MSICS.","['Manual Small Incision Cataract Surgery', '164 patients into two groups']","['ASCA', 'STA', 'Anterior Subconjunctival Anesthesia', 'manual small incision cataract surgery (MSICS', ""anterior subconjunctival anesthesia (ASCA) with sub-tenon's anesthesia (STA""]","['moderate-to-severe discomfort', 'ocular motility', 'Patient ocular motility', 'mild pain', 'deep-set eyes or exhibited excessive eye movements']","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0423224', 'cui_str': 'Sunken eyes'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}]",164.0,0.104715,"Results


Chemosis due to anesthesia and persistence of ocular motility in all four gaze directions were seen in all 82 patients of Group 1, but these did not prevent the surgeon from performing MSICS.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ajay', 'Affiliation': 'Department of Ophthalmology, The Oxford Medical College Hospital and Research Center, Bengaluru, Karnataka, India.'}, {'ForeName': 'Revuru Kanaka', 'Initials': 'RK', 'LastName': 'Subhasree', 'Affiliation': 'Department of Ophthalmology, P. E. S. Institute of Medical Sciences and Research, Kuppam, Andhra Pradesh, India.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Poka', 'Affiliation': 'Department of Ophthalmology, P. E. S. Institute of Medical Sciences and Research, Kuppam, Andhra Pradesh, India.'}]",Journal of current ophthalmology,['10.4103/2452-2325.329083']
2936,34766120,Is there a maximal effect of tranexamic acid in patients undergoing total knee arthroplasty? A randomized controlled trial.,"The optimal dosing regimen of tranexamic acid (TXA) has not been determined in total knee arthroplasty (TKA). In this study, patients were randomized to receive a high initial-dose (60 mg/kg) TXA before incision, followed by five doses 3, 6, 12, 18, and 24 hours later (A), or three doses 3, 12, and 24 hours later (B), or a single dose 3 hours later (C). The primary outcome was perioperative blood loss. Other outcomes such as, hemoglobin level, transfusion, the levels of fibrin (ogen) degradation products (FDP), D-dimer, C-reactive protein (CRP) and interleukin-6 (IL-6), coagulation parameters, and adverse events were also compared. The results showed that individuals in Groups A and B had reduced total and hidden blood loss (HBL), lower FDP, D-dimer, CRP, and IL-6 levels than in Group C. Such differences were also detected in HBL between Groups A and B. No differences were observed in other outcomes between Groups A and B. No differences were observed in coagulation parameters and adverse events among the three groups. In conclusion, a high initial-dose (60 mg/kg) TXA before TKA followed by three doses can be sufficient to achieve maximal effects on total blood loss, fibrinolysis, and inflammation.",2020,"The results showed that individuals in Groups A and B had reduced total and hidden blood loss (HBL), lower FDP, D-dimer, CRP, and IL-6 levels than in Group C. Such differences were also detected in HBL between Groups A and B. No differences were observed in other outcomes between Groups A and B. No differences were observed in coagulation parameters and adverse events among the three groups.",['patients undergoing total knee arthroplasty'],"['tranexamic acid (TXA', 'tranexamic acid']","['perioperative blood loss', 'total blood loss, fibrinolysis, and inflammation', 'HBL', 'coagulation parameters and adverse events', 'reduced total and hidden blood loss (HBL), lower FDP, D-dimer, CRP, and IL-6 levels', 'hemoglobin level, transfusion, the levels of fibrin (ogen) degradation products (FDP), D-dimer, C-reactive protein (CRP) and interleukin-6 (IL-6), coagulation parameters, and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0163275', 'cui_str': 'Fibrin degradation product'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",,0.223308,"The results showed that individuals in Groups A and B had reduced total and hidden blood loss (HBL), lower FDP, D-dimer, CRP, and IL-6 levels than in Group C. Such differences were also detected in HBL between Groups A and B. No differences were observed in other outcomes between Groups A and B. No differences were observed in coagulation parameters and adverse events among the three groups.","[{'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Orthopedics The First Affiliated Hospital of Chongqing Medical University Chongqing People's Republic of China.""}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopedics West China Hospital Sichuan University Chengdu People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics West China Hospital Sichuan University Chengdu People's Republic of China.""}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopedics West China Hospital Sichuan University Chengdu People's Republic of China.""}]",MedComm,['10.1002/mco2.23']
2937,34766090,"Comparative analysis of intra-articular injection of steroid and/or sodium hyaluronate in adhesive capsulitis: prospective, double-blind, randomized, placebo-controlled study.","Background


Few studies have reported the effects of simultaneous injections of corticosteroid (CS) and hyaluronic acid (HA) on adhesive capsulitis (AC) of the shoulder. This study investigated the synergistic effects of simultaneous intra-articular injections of CS and compared them to those of CS or HA alone.
Method


Sixty patients with AC were enrolled in this randomized, placebo-controlled trial. The participants were divided into 4 groups: saline, CS, HA, and CS with HA groups. The primary outcome measure was changes in the Shoulder Pain and Disability Index (SPADI) scores at one month. The secondary outcome measures included changes in pain, range of motion, muscle strength, and additional shoulder functional scores at 1 day, 1 week, and 1, 3, and 6 months after injection.
Results


After 1 month, changes of the SPADI scores were significantly higher in the CS with HA group (-58.4%) than those in the saline (-7.7%) and HA (-14.4%) groups. The score changed more in the CS with HA group than that in the CS group (-43.7%), but there was no significant difference. In the changes in pain, the CS with HA group showed significantly better and faster effects than the saline and HA groups. In the changes of range of motion, functional scores, the CS with HA group showed better results than the saline and HA groups.
Conclusion


In the treatment of AC, the simultaneous injection of CS and HA was more effective in improving SPADI scores at one month after injection than a single injection of CS or HA.",2021,"In the changes in pain, the CS with HA group showed significantly better and faster effects than the saline and HA groups.","['Method\n\n\nSixty patients with AC', 'adhesive capsulitis']","['simultaneous intra-articular injections of CS', 'saline, CS, HA, and CS with HA groups', 'CS or HA alone', 'placebo', 'corticosteroid (CS) and hyaluronic acid (HA', 'steroid and/or sodium hyaluronate']","['changes in pain, range of motion, muscle strength, and additional shoulder functional scores', 'SPADI scores', 'Shoulder Pain and Disability Index (SPADI) scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.242884,"In the changes in pain, the CS with HA group showed significantly better and faster effects than the saline and HA groups.","[{'ForeName': 'Sang-Hoon', 'Initials': 'SH', 'LastName': 'Oh', 'Affiliation': 'Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Dongjak-gu, Seoul, Korea.'}, {'ForeName': 'Won-Sub', 'Initials': 'WS', 'LastName': 'Sung', 'Affiliation': 'Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Dongjak-gu, Seoul, Korea.'}, {'ForeName': 'So-Hee', 'Initials': 'SH', 'LastName': 'Oh', 'Affiliation': 'Department of Biostatistics, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Dongjak-gu, Seoul, Korea.'}, {'ForeName': 'Chris Hyunchul', 'Initials': 'CH', 'LastName': 'Jo', 'Affiliation': 'Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Dongjak-gu, Seoul, Korea.'}]",JSES international,['10.1016/j.jseint.2021.07.017']
2938,34765977,A randomized phase II trial of efficacy and safety of the immunotherapy ALECSAT as an adjunct to radiotherapy and temozolomide for newly diagnosed glioblastoma.,"Background


There is an urgent need for effective treatments against glioblastoma (GBM). In this trial, we investigated the efficacy and safety of an adoptive cell-based immunotherapy.
Methods


Patients with newly diagnosed GBM were recruited at 4 study sites in Sweden. The patients were randomized 1:2 to receive either radiotherapy (RT), 60 Gy/30 fractions, with concomitant and adjuvant temozolomide (TMZ) only, or RT and TMZ with the addition of Autologous Lymphoid Effector Cells Specific Against Tumor (ALECSAT) in an open-label phase II trial. The primary endpoint was investigator-assessed progression-free survival (PFS). The secondary endpoints were survival and safety of ALECSAT.
Results


Sixty-two patients were randomized to either standard of care (SOC) with RT and TMZ alone (n = 22) or SOC with ALECSAT (n = 40). Median age was 57 years (range 38-69), 95% of the patients were in good performance status (WHO 0-1). There was no significant difference between the study arms (SOC vs ALECSAT + SOC) in PFS (7.9 vs 7.8 months; hazard ratio [HR] 1.28; 95% confidence interval [CI] 0.70-2.36;  P  = .42) or in median overall survival (OS) (18.3 vs 19.2 months; HR 1.16, 95% CI 0.58-2.31;  P  = .67). The treatment groups were balanced in terms of serious adverse events (52.4% vs 52.5%), but adverse events ≥grade 3 were more common in the experimental arm (81.0% vs 92.5%).
Conclusion


Addition of ALECSAT immunotherapy to standard treatment with radiochemotherapy was well tolerated but did not improve PFS or OS for patients with newly diagnosed GBM.",2021,"The treatment groups were balanced in terms of serious adverse events (52.4% vs 52.5%), but adverse events ≥grade 3 were more common in the experimental arm (81.0% vs 92.5%).
","['Median age was 57 years (range 38-69), 95% of the patients were in good performance status (WHO 0-1', 'Methods\n\n\nPatients with newly diagnosed GBM were recruited at 4 study sites in Sweden', 'newly diagnosed glioblastoma', 'patients with newly diagnosed GBM']","['SOC with ALECSAT', 'standard of care (SOC) with RT and TMZ alone', 'adoptive cell-based immunotherapy', 'immunotherapy ALECSAT', 'radiotherapy and temozolomide', 'ALECSAT immunotherapy', 'radiotherapy (RT), 60 Gy/30 fractions, with concomitant and adjuvant temozolomide (TMZ) only, or RT and TMZ with the addition of Autologous Lymphoid Effector Cells Specific Against Tumor (ALECSAT', 'radiochemotherapy']","['median overall survival (OS', 'investigator-assessed progression-free survival (PFS', 'PFS or OS', 'efficacy and safety', 'survival and safety of ALECSAT', 'serious adverse events']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0312740', 'cui_str': 'Immune effector cell'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0312740', 'cui_str': 'Immune effector cell'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",62.0,0.171584,"The treatment groups were balanced in terms of serious adverse events (52.4% vs 52.5%), but adverse events ≥grade 3 were more common in the experimental arm (81.0% vs 92.5%).
","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Werlenius', 'Affiliation': 'Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Stragliotto', 'Affiliation': 'Department of Neurology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Strandeus', 'Affiliation': 'Department of Oncology, Ryhov Hospital, Jönköping, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Blomstrand', 'Affiliation': 'Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Carén', 'Affiliation': 'Sahlgrenska Center for Cancer Research, Department of Laboratory Medicine, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Asgeir S', 'Initials': 'AS', 'LastName': 'Jakola', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Bertil', 'Initials': 'B', 'LastName': 'Rydenhag', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Dyregaard', 'Affiliation': 'Cytovac A/S, Hørsholm, Denmark.'}, {'ForeName': 'Karine N', 'Initials': 'KN', 'LastName': 'Dzhandzhugazyan', 'Affiliation': 'Cytovac A/S, Hørsholm, Denmark.'}, {'ForeName': 'Alexei F', 'Initials': 'AF', 'LastName': 'Kirkin', 'Affiliation': 'Cytovac A/S, Hørsholm, Denmark.'}, {'ForeName': 'Martin K', 'Initials': 'MK', 'LastName': 'Raida', 'Affiliation': 'Cytovac A/S, Hørsholm, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Smits', 'Affiliation': 'Institute of Neuroscience and Physiology, Department of Clinical Neuroscience, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kinhult', 'Affiliation': 'Department of Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.'}]",Neuro-oncology advances,['10.1093/noajnl/vdab156']
2939,34765985,Group-based Exercise Therapy Improves Psychosocial Health and Physical Fitness in Breast Cancer Patients in Hawai'i.,"Cancer diagnosis and treatment often negatively impact quality of life, worsening prognosis, and long-term survival in cancer patients. Rehabilitation is effective at reversing cancer-related effects, but these services are not standardized. An implementation study was conducted to determine the usability and efficacy of group-based exercise therapy delivered from an outpatient therapy clinic. Thirty breast cancer patients (mean age ± standard deviation [SD],= 55 ± 10 years) completed 36 90-minute group-based exercise sessions in small groups. Team-based exercises were used to foster peer interaction and social support. Usability was evaluated with participant feedback, adherence, and occurrence of adverse events. Effectiveness was measured with the Revised Piper Fatigue, the City of Hope Quality of Life (QOL), and the Beck Depression Inventories. Paired t-tests and 2-way ANOVAs were used to detect significance (P<.05); Cohen's d was used to measure effect size. Twenty-five patients completed the program; they reported that they liked the program design. One anticipated, moderate adverse event occurred. The intervention improved fatigue and QOL, where significant main effects of time were detected [Fatigue: (F(1,76)=29.78, P <.001); QOL: (F(1,80)=24.42, P<.0001)]. Improvements in the fatigue inventory's behavioral/security and sensory dimensions (Cohen's d=-0.43 and ȡ0.68, respectively) and the physical dimension of the QOL inventory were detected (Cohen's d=0.92). There were no significant changes in depression (P=.0735). Seven patients continued to participate in exercise classes for 2.5-years post-intervention, demonstrating achievability of program maintenance. Providing group-based exercise therapy services at an outpatient clinic is an effective and practical approach to improve cancer patients' QOL.",2021,"Improvements in the fatigue inventory's behavioral/security and sensory dimensions (Cohen's d=-0.43 and ȡ0.68, respectively) and the physical dimension of the QOL inventory were detected (Cohen's d=0.92).","['Thirty breast cancer patients (mean age ± standard deviation [SD],= 55 ± 10 years) completed 36', ""cancer patients' QOL"", 'cancer patients', ""Breast Cancer Patients in Hawai'i""]","['group-based exercise therapy', 'Exercise Therapy', 'Providing group-based exercise therapy services', '90-minute group-based exercise sessions']","['physical dimension of the QOL inventory', ""fatigue inventory's behavioral/security and sensory dimensions"", 'usability and efficacy', 'participant feedback, adherence, and occurrence of adverse events', 'Revised Piper Fatigue, the City of Hope Quality of Life (QOL), and the Beck Depression Inventories', 'Psychosocial Health and Physical Fitness', 'QOL', 'fatigue and QOL', 'depression']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018619', 'cui_str': 'Hawaii state'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",30.0,0.0117368,"Improvements in the fatigue inventory's behavioral/security and sensory dimensions (Cohen's d=-0.43 and ȡ0.68, respectively) and the physical dimension of the QOL inventory were detected (Cohen's d=0.92).","[{'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Teranishi-Hashimoto', 'Affiliation': 'Rehabilitation Hospital of the Pacific, Honolulu, HI (CT, EL).'}, {'ForeName': 'Erin O', 'Initials': 'EO', 'LastName': 'Bantum', 'Affiliation': ""University of Hawai'i Cancer Center, Honolulu, HI (EOB).""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Conde', 'Affiliation': 'Department of Oncology, Straub Medical Center, Honolulu, HI (FC).'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Rehabilitation Hospital of the Pacific, Honolulu, HI (CT, EL).'}, {'ForeName': 'Paulette M', 'Initials': 'PM', 'LastName': 'Yamada', 'Affiliation': ""Department of Kinesiology and Rehabilitative Services, University of Hawai'i at Manoa, Honolulu, HI (PMY).""}]",Hawai'i journal of health & social welfare,[]
2940,34765975,"Impact of lymphopenia on survival for elderly patients with glioblastoma: A secondary analysis of the CCTG CE.6 (EORTC 26062-22061, TROG03.01) randomized clinical trial.","Background


Lymphopenia may lead to worse outcomes for glioblastoma patients. This study is a secondary analysis of the CCTG CE.6 trial evaluating the impact of chemotherapy and radiation on lymphopenia, and effects of lymphopenia on overall survival (OS).
Methods


CCTG CE.6 randomized elderly glioblastoma patients (≥ 65 years) to short-course radiation alone (RT) or short-course radiation with temozolomide (RT + TMZ). Lymphopenia (mild-moderate: grade 1-2; severe: grade 3-4) was defined per CTCAE v3.0, and measured at baseline, 1 week and 4 weeks post-RT. Preselected key factors for analysis included age, sex, ECOG, resection extent, MGMT methylation, Mini-Mental State Examination, and steroid use. Multinomial logistic regression and multivariable Cox regression models were used to identify lymphopenia-associated factors and association with survival.
Results


Five hundred and sixty-two patients were analyzed (281 RT vs 281 RT+TMZ). At baseline, both arms had similar rates of mild-moderate (21.4% vs 21.4%) and severe (3.2% vs 2.9%) lymphopenia. However, at 4 weeks post-RT, RT+TMZ was more likely to develop lymphopenia (mild-moderate: 27.9% vs 18.2%; severe: 9.3% vs 1.8%; p<0.001). Developing any lymphopenia post-RT was associated with baseline lymphopenia ( P  < .001). Baseline lymphopenia (hazard ratio [HR] 1.3) was associated with worse OS (HR: 1.30, 95% confidence interval [CI] 1.05-1.62;  P  = .02), regardless of MGMT status.
Conclusions


Development of post-RT lymphopenia is associated with addition of TMZ and baseline lymphopenia and not with RT alone in patients treated with short-course radiation. However, regardless of MGMT status, only baseline lymphopenia is associated with worse OS, which may be considered as a prognostic biomarker for elderly glioblastoma patients.",2021,Developing any lymphopenia post-RT was associated with baseline lymphopenia ( P  < .001).,"['elderly glioblastoma patients', 'elderly patients with glioblastoma', 'Five hundred and sixty-two patients were analyzed (281 RT vs 281 RT+TMZ', 'glioblastoma patients']","['short-course radiation alone (RT) or short-course radiation with temozolomide (RT + TMZ', 'TMZ']","['overall survival (OS', 'develop lymphopenia', 'Lymphopenia', 'baseline lymphopenia', 'Baseline lymphopenia', 'mild-moderate', 'severe']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",562.0,0.220962,Developing any lymphopenia post-RT was associated with baseline lymphopenia ( P  < .001).,"[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Song', 'Affiliation': 'Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Keyue', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': ""Department of Public Health Sciences, Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Iyad', 'Initials': 'I', 'LastName': 'Alnahhas', 'Affiliation': 'Department of Neurological Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Normand J', 'Initials': 'NJ', 'LastName': 'Laperriere', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Center, Toronto, Ontario, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Perry', 'Affiliation': 'Department of Medicine, Division of Neurology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Warren P', 'Initials': 'WP', 'LastName': 'Mason', 'Affiliation': 'Department of Medicine, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Winch', 'Affiliation': ""Department of Public Health Sciences, Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': ""O'Callaghan"", 'Affiliation': ""Department of Public Health Sciences, Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Johan J', 'Initials': 'JJ', 'LastName': 'Menten', 'Affiliation': 'Department of Experimental Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Department of Medical oncology, IRCCS Istituto Scienze Neurologiche - Bologna, Italy.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Fay', 'Affiliation': 'Genesis Cancer Care, Newcastle, NSW, Australia.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osoba', 'Affiliation': 'QOL Consulting, West Vancouver, British Columbia, Canada.'}, {'ForeName': 'J Gregory', 'Initials': 'JG', 'LastName': 'Cairncross', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Roa', 'Affiliation': 'Division of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Division of Neurology, Heidelberg University Medical Center, Clinical Cooperation Unit Neurooncology, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Wenyin', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}]",Neuro-oncology advances,['10.1093/noajnl/vdab153']
2941,34765982,The Effect of Chaplain Patient Navigators and Multidisciplinary Family Meetings on Patient Outcomes in the ICU: The Critical Care Collaboration and Communication Project.,"OBJECTIVES


To assess the effectiveness of a chaplain patient navigator in improving outcomes and reducing costs in the ICU setting.
DESIGN


A randomized controlled trial at a large, urban, academic community hospital in Baltimore, Maryland.
SETTING/PATIENTS


All patients admitted to the Johns Hopkins Bayview Medical Center Cardiac and Medical ICUs between March 2015 and December 2015.
INTERVENTIONS


Patients in the intervention group were assigned a chaplain patient navigator to facilitate communication, offer support, and setup multidisciplinary family meetings.
MEASUREMENTS AND MAIN RESULTS


The primary outcomes were hospital and ICU length of stay. Secondary outcomes included total and ICU charges, 60- and 90-day readmission rates, and the number of palliative care consults. For all outcomes, patients were included in the intention-to-treat analyses only if they remained in the ICU greater than 24 hours. In total, 1,174 were randomly assigned to ""usual care"" ( n  = 573) or to the intervention ( n  = 601). In the intervention group, 44.8% (269/601) had meetings within 24 hours of admission and, of those patients, 32.8% (88/268) took part in the larger multidisciplinary family meeting 2-3 days later. The intervention group had longer mean adjusted hospital length of stay (7.78 vs 8.63 d;  p  ≤ 0.001) and mean ICU length of stay (3.65 vs 3.87 d;  p  = 0.029). In addition, they had greater total and ICU charges. There were no differences in other outcomes. Of note, only differences in total and ICU charges remained when controlling for case-mix index, which were greater in the intervention group.
CONCLUSIONS


Although the chaplain patient navigator anecdotally enhanced communication, our study found an increase in hospital and ICU length of stay as well as cost. Since other studies have shown benefits in some clinical outcomes, projects focused on patient navigators may learn lessons from our study in order to better prioritize family meetings, gather indicators of communication quality, and identify the optimal patient navigator operational context.",2021,The intervention group had longer mean adjusted hospital length of stay (7.78 vs 8.63 d;  p  ≤ 0.001) and mean ICU length of stay (3.65 vs 3.87 d;  p  = 0.029).,"['All patients admitted to the Johns Hopkins Bayview Medical Center Cardiac and Medical ICUs between March 2015 and December 2015', 'large, urban, academic community hospital in Baltimore, Maryland']","['chaplain patient navigator to facilitate communication, offer support, and setup multidisciplinary family meetings', 'chaplain patient navigator', 'Chaplain Patient Navigators and Multidisciplinary Family Meetings', 'usual care']","['total and ICU charges', 'mean ICU length of stay', 'longer mean adjusted hospital length of stay', 'hospital and ICU length of stay', 'total and ICU charges, 60- and 90-day readmission rates, and the number of palliative care consults']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}]","[{'cui': 'C0558269', 'cui_str': 'Chaplain'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",1174.0,0.125277,The intervention group had longer mean adjusted hospital length of stay (7.78 vs 8.63 d;  p  ≤ 0.001) and mean ICU length of stay (3.65 vs 3.87 d;  p  = 0.029).,"[{'ForeName': 'Fahid', 'Initials': 'F', 'LastName': 'Alghanim', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Furqan', 'Affiliation': 'Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Prichett', 'Affiliation': 'Biostatistics, Epidemiology, and Data Management (BEAD) Core, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Jondavid', 'Initials': 'J', 'LastName': 'Landon', 'Affiliation': 'Department of Emergency Medicine, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Tao', 'Affiliation': 'Biostatistics, Epidemiology, and Data Management (BEAD) Core, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Selvam', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, FL.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Leslie', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hartman-Shea', 'Affiliation': 'Department of Social Work, Johns Hopkins Bayview Medical Center, Baltimore, MD.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Teague', 'Affiliation': 'Department of Spiritual Care and Chaplaincy, Johns Hopkins Bayview Medical Center, Baltimore, MD.'}, {'ForeName': 'Wayman', 'Initials': 'W', 'LastName': 'Scott', 'Affiliation': 'Counseling and Support Services, Gilchrist Hospice, Greater Baltimore Medical Center, Towson, MD.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kraeuter', 'Affiliation': 'Department of Nursing, Johns Hopkins Bayview Medical Center, Baltimore, MD.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hicks', 'Affiliation': 'Department of Nursing, Johns Hopkins Bayview Medical Center, Baltimore, MD.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Medicine, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'York', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Blanding', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Zakaria', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",Critical care explorations,['10.1097/CCE.0000000000000574']
2942,34758252,Angiotensin Receptor-Neprilysin Inhibition in Acute Myocardial Infarction.,"BACKGROUND


In patients with symptomatic heart failure, sacubitril-valsartan has been found to reduce the risk of hospitalization and death from cardiovascular causes more effectively than an angiotensin-converting-enzyme inhibitor. Trials comparing the effects of these drugs in patients with acute myocardial infarction have been lacking.
METHODS


We randomly assigned patients with myocardial infarction complicated by a reduced left ventricular ejection fraction, pulmonary congestion, or both to receive either sacubitril-valsartan (97 mg of sacubitril and 103 mg of valsartan twice daily) or ramipril (5 mg twice daily) in addition to recommended therapy. The primary outcome was death from cardiovascular causes or incident heart failure (outpatient symptomatic heart failure or heart failure leading to hospitalization), whichever occurred first.
RESULTS


A total of 5661 patients underwent randomization; 2830 were assigned to receive sacubitril-valsartan and 2831 to receive ramipril. Over a median of 22 months, a primary-outcome event occurred in 338 patients (11.9%) in the sacubitril-valsartan group and in 373 patients (13.2%) in the ramipril group (hazard ratio, 0.90; 95% confidence interval [CI], 0.78 to 1.04; P = 0.17). Death from cardiovascular causes or hospitalization for heart failure occurred in 308 patients (10.9%) in the sacubitril-valsartan group and in 335 patients (11.8%) in the ramipril group (hazard ratio, 0.91; 95% CI, 0.78 to 1.07); death from cardiovascular causes in 168 (5.9%) and 191 (6.7%), respectively (hazard ratio, 0.87; 95% CI, 0.71 to 1.08); and death from any cause in 213 (7.5%) and 242 (8.5%), respectively (hazard ratio, 0.88; 95% CI, 0.73 to 1.05). Treatment was discontinued because of an adverse event in 357 patients (12.6%) in the sacubitril-valsartan group and 379 patients (13.4%) in the ramipril group.
CONCLUSIONS


Sacubitril-valsartan was not associated with a significantly lower incidence of death from cardiovascular causes or incident heart failure than ramipril among patients with acute myocardial infarction. (Funded by Novartis; PARADISE-MI ClinicalTrials.gov number, NCT02924727.).",2021,Sacubitril-valsartan was not associated with a significantly lower incidence of death from cardiovascular causes or incident heart failure than ramipril among patients with acute myocardial infarction.,"['5661 patients underwent randomization; 2830', 'patients with acute myocardial infarction', 'We randomly assigned patients with myocardial infarction complicated by a reduced left ventricular ejection fraction, pulmonary congestion, or both to receive either', 'Acute Myocardial Infarction', 'patients with symptomatic heart failure']","['sacubitril-valsartan', 'Angiotensin Receptor-Neprilysin Inhibition', 'Sacubitril-valsartan', 'sacubitril-valsartan (97 mg of sacubitril and 103 mg of valsartan twice daily) or ramipril', 'ramipril']","['death from cardiovascular causes', 'Death from cardiovascular causes or hospitalization for heart failure', 'death', 'death from cardiovascular causes or incident heart failure (outpatient symptomatic heart failure or heart failure leading to hospitalization), whichever occurred first']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0242073', 'cui_str': 'Pulmonary congestion'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0025250', 'cui_str': 'Lymphocyte antigen CD10'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",5661.0,0.390184,Sacubitril-valsartan was not associated with a significantly lower incidence of death from cardiovascular causes or incident heart failure than ramipril among patients with acute myocardial infarction.,"[{'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Jean-Lucien', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Philippe G', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Cikes', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Carmine G', 'Initials': 'CG', 'LastName': 'De Pasquale', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'East', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Karola', 'Initials': 'K', 'LastName': 'Jering', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Freny', 'Initials': 'F', 'LastName': 'Vaghaiwalla Mody', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Petrov', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sim', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Meer', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Yinong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Jianjian', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women's Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) - both in California; Duke University Medical Center, Durham, NC (C.B.G.); Rigshospitalet, Blegdamsvej, University of Copenhagen (L.K.), and the Department of Cardiology, Herlev-Gentofte University Hospital (M. Schou) - both in Copenhagen; National Association of Hospital Cardiologists Research Center, Florence (A.P.M.), and the Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo (M. Senni) - both in Italy; Washington University School of Medicine, St. Louis (D.L.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P.); Montreal Heart Institute, University of Montreal, Montreal (J.-L.R.); Université de Paris, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials and INSERM Unité 1148, Paris (P.G.S.); Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo (O.B.); the Department of Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia (M.C.); the Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia (C.G.D.P.); Baylor Soltero CV Research Center, Baylor Scott and White Heart and Vascular Hospital, Dallas (C.E.); Cardiology Service, Sanatorio Modelo Quilmes, Quilmes, Argentina (A.F.); the Department of Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin (U.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.); National Heart Center Singapore, Singapore (D.S.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (P.M.); and Novartis, East Hanover, NJ (M.L., Y.Z., J.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2104508']
2943,34760248,"Effect of protein and carbohydrate distribution among meals on quality of life, sleep quality, inflammation, and oxidative stress in patients with type 2 diabetes: A single-blinded randomized controlled trial.","Background/Objectives


Patients with diabetes mellitus have a lower quality of life and sleep compared with healthy individuals. Nutrition therapy has an important role in the management of diabetes and can improve inflammation and quality of life in patients with diabetes. The present study aimed to evaluate the effect of high-protein versus high-carbohydrate intake during evening meal on quality of life, sleep quality, inflammation, and oxidative stress in subjects with type 2 diabetes.
Subjects/Methods


This is a 10-week randomized controlled trial. 96 adult patients with type 2 diabetes were assigned into one of the following three groups: standard evening meal (ST), high-carbohydrate evening meal (HC), and high-protein evening meal (HP). The effect of these diets was examined on high-sensitivity C-reactive protein, malondialdehyde, quality of life, and sleep quality.
Results


Sleep quality improved significantly in all groups ( p  < .05). The quality of life and high-sensitivity C-reactive protein improved in all groups except for the HP group ( p  < .05). Serum malondialdehyde level did not change significantly throughout the study ( p  > .05).
Conclusions


Small manipulation of protein and carbohydrate distribution among the meals might not affect sleep quality. A diet with an even distribution of macronutrients among the meals or with a higher percentage of carbohydrates in the evenings can improve the quality of life and reduce inflammation in patients with type 2 diabetes, while a diet with a higher percentage of protein in the evenings may not improve it.",2021,The quality of life and high-sensitivity C-reactive protein improved in all groups except for the HP group ( p  < .05).,"['Patients with diabetes mellitus', 'patients with diabetes', 'subjects with type 2 diabetes', '96 adult patients with type 2 diabetes', 'patients with type 2 diabetes']","['Nutrition therapy', 'protein and carbohydrate distribution', 'high-protein versus high-carbohydrate intake', 'standard evening meal (ST), high-carbohydrate evening meal (HC), and high-protein evening meal (HP']","['Sleep quality', 'quality of life and reduce inflammation', 'high-sensitivity C-reactive protein, malondialdehyde, quality of life, and sleep quality', 'quality of life and sleep', 'quality of life and high-sensitivity C-reactive protein', 'sleep quality', 'inflammation and quality of life', 'Serum malondialdehyde level', 'quality of life, sleep quality, inflammation, and oxidative stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0585040', 'cui_str': 'Evening meal'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",96.0,0.0496408,The quality of life and high-sensitivity C-reactive protein improved in all groups except for the HP group ( p  < .05).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nouripour', 'Affiliation': 'Department of Clinical Nutrition School of Nutrition and Food Sciences Shiraz University of Medical Sciences Shiraz Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Mazloom', 'Affiliation': 'Department of Clinical Nutrition School of Nutrition and Food Sciences Shiraz University of Medical Sciences Shiraz Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fararouei', 'Affiliation': 'Department of Epidemiology School of Health Shiraz University of Medical Sciences Shiraz Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zamani', 'Affiliation': 'Department of Internal medicine School of Medicine, Endocrinology and Metabolism Research Center Shiraz University of Medical Sciences Shiraz Iran.'}]",Food science & nutrition,['10.1002/fsn3.2570']
2944,34760234,"A randomized, double blind, parallel, placebo-controlled study to investigate the efficacy of  Lactobacillus paracasei  N1115 in gut development of young children.","In this clinical trial, the safety and effectiveness of  Lactobacillus paracasei  N1115 (LP N1115) were investigated as a potential probiotic to enhance gut development in young children born by caesarean section. Infants and young children between the ages of 6 months and 3 years were administered with a probiotic consisting of LP N1115 strain ( n  = 30) or placebo supplement ( n  = 30) over an 8 weeks intervention. And the stool consistency, bowel habits, salivary cortisol, fecal microbiota, and short-chain fatty acid metabolism were investigated. Efficacy data were obtained from 58 participants who completed the study. Overall, the placebo functioned similarly to LP N1115 group in relation to stool consistency, gastrointestinal symptoms, salivary cortisol, and short-chain fatty acids. However, the scoring data relating to the 6-18 months subgroup receiving LP N1115 remained stable over 8 weeks in comparison to placebo. Analysis of the fecal microbiota using 16S rRNA amplicon sequencing revealed that the phyla Firmicutes represented 62% of the microbial relative abundance in the feces of the subjects during the intervening period. No significant changes in alpha- or beta-diversity were noted between the placebo and LP N1115 groups overtime and at each time point. Differential abundance analysis indicated an increase in  Lactobacillus  in LP N1115 group at weeks 4 ( p  < .05) and 8 ( p  < .05) in comparison to the placebo group. These results suggest that probiotic supplementation with LP N1115 was well tolerated by the young children and subtle changes in the microbiome were noted throughout the intervention period.",2021,Differential abundance analysis indicated an increase in  Lactobacillus  in LP N1115 group at weeks 4 ( p  < .05) and 8 ( p  < .05) in comparison to the placebo group.,"['young children', 'Infants and young children between the ages of 6\xa0months and 3\xa0years', 'young children born by caesarean section', '58 participants who completed the study']","['Lactobacillus paracasei  N1115', 'placebo supplement', 'Lactobacillus paracasei  N1115 (LP N1115', 'placebo', 'probiotic consisting of LP N1115 strain']","['stool consistency, bowel habits, salivary cortisol, fecal microbiota, and short-chain fatty acid metabolism', 'alpha- or beta-diversity', 'stool consistency, gastrointestinal symptoms, salivary cortisol, and short-chain fatty acids', 'Lactobacillus']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1271069', 'cui_str': 'Born by cesarean section'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}]",,0.212035,Differential abundance analysis indicated an increase in  Lactobacillus  in LP N1115 group at weeks 4 ( p  < .05) and 8 ( p  < .05) in comparison to the placebo group.,"[{'ForeName': 'Shijie', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Shijiazhuang Junlebao Dairy Co. Ltd. Shijiazhuang China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Xun', 'Affiliation': 'Shijiazhuang Junlebao Dairy Co. Ltd. Shijiazhuang China.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Ahern', 'Affiliation': 'School of Microbiology University College Cork Cork Ireland.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Shijiazhuang Junlebao Dairy Co. Ltd. Shijiazhuang China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Shijiazhuang Junlebao Dairy Co. Ltd. Shijiazhuang China.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Shijiazhuang Junlebao Dairy Co. Ltd. Shijiazhuang China.'}, {'ForeName': 'Reynolds Paul', 'Initials': 'RP', 'LastName': 'Ross', 'Affiliation': 'School of Microbiology University College Cork Cork Ireland.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Doolan', 'Affiliation': 'Atlantia Food Clinical Trials Ltd. Cork Ireland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stanton', 'Affiliation': 'APC Microbiome Institute University College Cork Cork Ireland.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Shijiazhuang Junlebao Dairy Co. Ltd. Shijiazhuang China.'}]",Food science & nutrition,['10.1002/fsn3.2533']
2945,34760143,The Factors Affecting Orthodontic Pain with Periodontitis.,"The occurrence of pain is often closely related to the psychological status, and the threshold for pain tolerance varies from patient to patient. In short, the factors affecting orthodontic pain are diverse and have individual differences. Tooth pain after the first force of intraoral malocclusion orthodontic treatment is one of the common complications of fixed orthodontic treatment, which often affects the outcome of treatment of patients with malocclusion and their subjective satisfaction with fixed orthodontic treatment. The purpose of the paper was to investigate the basic patterns and influencing factors of dental pain in fixed orthodontic patients within seven days after the initial wearing of straight arch aligners and the analysis of the effect of psychological intervention on dental pain using the visual simulation scoring method. According to the inclusion criteria of the experimental design, 89 patients who visited the Department of Orthodontics of Hospital for malocclusion were randomly divided into observation group and control group, and the observation group used chewing gum as psychological intervention, while the control group did not use any intervention. The effect of psychological intervention on periodontal pain was analyzed. The results of the paper were that all but 3 of the 89 patients had no pain, and all the patients had different degrees of dental pain at different points in time.",2021,"Tooth pain after the first force of intraoral malocclusion orthodontic treatment is one of the common complications of fixed orthodontic treatment, which often affects the outcome of treatment of patients with malocclusion and their subjective satisfaction with fixed orthodontic treatment.","['patients with malocclusion and their subjective satisfaction with fixed orthodontic treatment', 'fixed orthodontic patients within seven days after the initial wearing of straight arch aligners', '89 patients who visited the Department of Orthodontics of Hospital for malocclusion']","['psychological intervention', 'observation group and control group, and the observation group used chewing gum as psychological intervention, while the control group did not use any intervention']","['Tooth pain', 'dental pain', 'periodontal pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",89.0,0.0325026,"Tooth pain after the first force of intraoral malocclusion orthodontic treatment is one of the common complications of fixed orthodontic treatment, which often affects the outcome of treatment of patients with malocclusion and their subjective satisfaction with fixed orthodontic treatment.","[{'ForeName': 'Yuzhi', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Stomatology, First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang 550001, China.'}, {'ForeName': 'Songjiang', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang 550001, China.'}]",Journal of healthcare engineering,['10.1155/2021/8942979']
2946,34760128,Prevention of Postpartum Weight Retention during One Year after Childbirth by Prenatal Nutrition Education: A Randomized Controlled Trial.,"Background


It seems that 14-25% of the women retain at least 5 kg weight from 6 to 12 months after delivery and gestational weight gain is the most important reason of weight retention. Thus, we assessed the effect of prenatal nutrition education program on the retained weights at 8, 26, and 52 weeks after delivery in primiparous women.
Methods


This randomized controlled trial was implemented among 192 primiparous pregnant women in five hospitals, fifteen community health centers, and fifteen private offices. Self-developed questionnaire was used to collect the participants' characteristics. A 72-hr dietary recall was applied to evaluate the food intakes before and after intervention. The pregnancy physical activity questionnaire determined the physical activity score. The participants' weights at 8, 26, and 52 weeks after delivery were measured by a digital beam.
Results


The means of postpartum weight decreased in both groups, but nutrition education was significantly effective on reducing postpartum weight in intervention group (β = -3.112, SE =. 7384,  P  < 0.001). Also, the women in intervention group had less retained weight compared to control during the follow-up (β = -3.35, SE = 0.75, p < 0.001). The proportion of pregnant women in intervention group who reached to their pre-gravid weight was more than control during the follow-up (OR = 2.86, 95% CI: 1.62, 5.07).
Conclusions


Nutrition education considering an individualized calorie-appropriate diet for each pregnant woman and based on the national guideline is effective on postpartum weight retention and reaching to pre-gravid weight.",2021,"The means of postpartum weight decreased in both groups, but nutrition education was significantly effective on reducing postpartum weight in intervention group (β = -3.112, SE =.","['Postpartum Weight Retention during One Year after Childbirth by Prenatal Nutrition Education', '192 primiparous pregnant women in five hospitals, fifteen community health centers, and fifteen private offices', 'primiparous women']",['prenatal nutrition education program'],"['pre-gravid weight', 'pregnancy physical activity questionnaire determined the physical activity score', 'retained weight', 'postpartum weight']","[{'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0598901', 'cui_str': 'Prenatal Nutritional Physiological Phenomenon'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0598901', 'cui_str': 'Prenatal Nutritional Physiological Phenomenon'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",,0.0321723,"The means of postpartum weight decreased in both groups, but nutrition education was significantly effective on reducing postpartum weight in intervention group (β = -3.112, SE =.","[{'ForeName': 'Seyed Saeed', 'Initials': 'SS', 'LastName': 'Mazloomy Mahmoodabad', 'Affiliation': 'Department of Health Education and Promotion, Social Determinants of Health Research Center, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sajedeh', 'Initials': 'S', 'LastName': 'Molavi', 'Affiliation': 'Msc in Counselling Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Nadjarzadeh', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Mardanian', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Riahi', 'Affiliation': 'Ph.D, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Ardian', 'Affiliation': 'Social Determinants of Health Research Center, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Kobra', 'Initials': 'K', 'LastName': 'Salehi', 'Affiliation': 'Department of Midwifery and Reproductive Health, Nursing and Midwifery Care Research Center, School of Nursing and Midwifery, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Goodarzi-Khoigani', 'Affiliation': 'Ph.D, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",International journal of preventive medicine,['10.4103/ijpvm.IJPVM_37_20']
2947,34760536,Comparing the effectiveness of training course formats for point-of-care ultrasound in the third trimester of pregnancy.,"Introduction


The availability of obstetric point-of-care ultrasound (PoCUS) services has been shown to improve pregnancy outcomes in regional and remote areas both in Australia and around the world. There is an increasing demand for efficient, cost-effective PoCUS courses for monitoring the fetus in the third trimester of pregnancy.
Aim


To compare the effectiveness of targeted PoCUS courses provided for health professionals that assess the fetus during the third trimester of pregnancy.
Method


The skill-teaching curriculum and competency outcomes of six obstetric PoCUS courses were compared. There were 55 learners with no prior ultrasound experience including 23 with English as a second language. Course duration ranged from 4 to 18 h, didactic lecture time up to 6 h and practical scanning sessions of 3-12 h. Learner/tutor ratio varied from 1:1 to 6:1. All courses included the teaching of knobology, image optimisation and probe manipulation. Practical sessions included supervised scanning of ultrasound phantoms and scanning women in the third trimester of pregnancy. The teaching outcomes that were assessed included image optimisation, determination of fetal lie, fetal heart rate, measuring the single deepest pocket of amniotic fluid, identifying the placental position and basic fetal biometry. The same pre- and post-course multiple choice test and course evaluation forms were used for every programme.
Results


All participants achieved the limited course objectives, regardless of the differences in the course formats.
Conclusion


This study confirms that obstetric PoCUS courses can provide the initial basic knowledge and scanning skills required to perform limited scope third-trimester scanning.",2019,The availability of obstetric point-of-care ultrasound (PoCUS) services has been shown to improve pregnancy outcomes in regional and remote areas both in Australia and around the world.,['55 learners with no prior ultrasound experience including 23 with English as a second language'],['care ultrasound (PoCUS) services'],"['image optimisation, determination of fetal lie, fetal heart rate, measuring the single deepest pocket of amniotic fluid, identifying the placental position and basic fetal biometry', 'didactic lecture time']","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0424920', 'cui_str': 'English as a second language'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0002638', 'cui_str': 'Amniotic fluid'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005544', 'cui_str': 'Biometry'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",55.0,0.066805,The availability of obstetric point-of-care ultrasound (PoCUS) services has been shown to improve pregnancy outcomes in regional and remote areas both in Australia and around the world.,"[{'ForeName': 'Susan Campbell', 'Initials': 'SC', 'LastName': 'Westerway', 'Affiliation': 'School of Dentistry & Health Sciences Charles Sturt University Wagga Wagga New South Wales Australia.'}]",Australasian journal of ultrasound in medicine,['10.1002/ajum.12125']
2948,34760803,Evaluation of Novel Topical Camel Whey Protein Gel for the Treatment of Recurrent Aphthous Stomatitis: Randomized Clinical Study.,"Aim


The aim of this article is to evaluate the topical effect of camel whey protein (CWP) on the healing of recurrent aphthous stomatitis (RAS) and the serum levels of interleukin (IL)-1, IL-6, and tumor necrosis factor (TNF)-α.
Materials and Methods


Forty patients with minor RAS were randomly assigned into control and study groups. The control group applied placebo methylcellulose gel topically over the aphthous ulcer, whereas the study group used CWP dissolved in methylcellulose gel topically over the aphthous ulcer. Healing period, pain scale, and serum inflammatory biomarkers were evaluated before and after gel application. Collected data were analyzed statistically using the paired  t -test or independent sample  t -test.
Results


Ulcer healing period, pain scale, and immunological biomarkers were statistically improved in both groups with significant shortening of the ulcer duration and significant regulation of immunological values related to the study group.
Conclusion


Topical CWP gel is potentially effective in the treatment of RAS.",2021,"Results


Ulcer healing period, pain scale, and immunological biomarkers were statistically improved in both groups with significant shortening of the ulcer duration and significant regulation of immunological values related to the study group.
","['Recurrent Aphthous Stomatitis', 'Forty patients with minor RAS']","['camel whey protein (CWP', 'Novel Topical Camel Whey Protein Gel', 'placebo', 'Topical CWP gel']","['Healing period, pain scale, and serum inflammatory biomarkers', 'immunological values', 'Ulcer healing period, pain scale, and immunological biomarkers']","[{'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]","[{'cui': 'C0006801', 'cui_str': 'Camelus'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",40.0,0.0161581,"Results


Ulcer healing period, pain scale, and immunological biomarkers were statistically improved in both groups with significant shortening of the ulcer duration and significant regulation of immunological values related to the study group.
","[{'ForeName': 'Walid A', 'Initials': 'WA', 'LastName': 'Elamrousy', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Kafrelsheikh University, Kafr Elsheikh, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Mortada', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Malak', 'Initials': 'M', 'LastName': 'Shoukheba', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Tanta University, Tanta, Egypt.'}]",Journal of International Society of Preventive & Community Dentistry,['10.4103/jispcd.JISPCD_172_21']
2949,34760706,"Short-Term Outcomes of Single-Incision Laparoscopic Surgery for Colorectal Cancer: A Single-Center, Open-Label, Non-Inferiority, Randomized Clinical Trial.","Objective


To date, well-designed randomized controlled trials examining the safety, efficacy, and long-term outcomes of single-incision laparoscopic surgery (SILS) for colorectal cancer are scarce. The aim of the current study was to compare short-term outcomes of SILS for colorectal cancer with conventional laparoscopic surgery (CLS).
Methods


Between June 28, 2017, and June 29, 2019, a single-center, open-label, non-inferiority, randomized clinical trial was conducted at the Department of General Surgery, Ruijin Hospital (North), Shanghai Jiaotong University School of Medicine in Shanghai, China. In total, 200 patients diagnosed or suspected of colorectal cancer (cT 1-4a N 0-2 M 0 ) were randomly assigned to either the SILS or CLS group in a 1:1 ratio. The primary outcome was early morbidity rate. Secondary outcomes included intraoperative outcomes, pain intensity, postoperative recovery, pathologic outcomes, and long-term outcomes.
Results


In total, 193 participants (SILS, 97; CLS, 96) were analyzed in the modified intention-to-treat (MITT) population. Among them, 48 underwent right hemicolectomy (SILS  n  = 23, 23.7% and MLS  n  = 25, 26%), 15 underwent left hemicolectomy (SILS  n  = 6, 6.2% and MLS  n  = 9, 9.4%), 1 underwent transverse colectomy (MLS  n  = 1, 1%), 57 underwent sigmoidectomy (SILS  n  = 32, 33% and MLS  n  = 25, 26%), and 72 underwent anterior resection (SILS  n  = 36, 37.1% and MLS  n  = 36, 37.5%). No significant differences were observed in the baseline characteristics. The intraoperative complication was comparable between the two groups [5 (5.2%) vs. 4 (4.2%); difference, 1%; 95% CI, -5.8% to 7.8%;  p  > 0.999) and so was postoperative complication rates [10 (10.3%) vs. 14 (14.6%); difference, -4.3%; 95% CI, -13.9% to 5.3%;  p  = 0.392]. The SILS group showed shorter incision length [median (IQR), 4 (3.5-5) vs. 6.6 (6-7.5),  p  < 0.001] and lower VAS scores on the first [median (IQR), 4 (3-5) vs. 4 (4-5),  p  = 0.002] and the second day [median (IQR), 2 (1.5-3) vs. 3 (2-4),  p  < 0.001] after surgery. No statistically significant difference was found in other measured outcomes.
Conclusions


Compared with CLS, SILS performed by experienced surgeons for selected colorectal cancer patients is non-inferior with good short-term safety and has the advantage of reducing postoperative pain.
Clinical Trial Registration


ClinicalTrials.gov, identifier NCT03151733.",2021,"The SILS group showed shorter incision length [median (IQR), 4 (3.5-5) vs. 6.6 (6-7.5),  p  < 0.001] and lower VAS scores on the first [median (IQR), 4 (3-5) vs. 4 (4-5),  p  = 0.002] and the second day [median (IQR), 2 (1.5-3) vs. 3 (2-4),  p  < 0.001] after surgery.","['Methods\n\n\nBetween June 28, 2017, and June 29, 2019, a single-center, open-label, non-inferiority, randomized clinical trial was conducted at the Department of General Surgery, Ruijin Hospital (North), Shanghai Jiaotong University School of Medicine in Shanghai, China', 'selected colorectal cancer patients', 'Colorectal Cancer', '193 participants (SILS, 97; CLS, 96) were analyzed in the modified intention-to-treat (MITT) population', '200 patients diagnosed or suspected of colorectal cancer (cT 1-4a N 0-2 M 0 ']","['CLS', 'SILS or CLS', 'single-incision laparoscopic surgery (SILS', 'conventional laparoscopic surgery (CLS', 'SILS', 'Single-Incision Laparoscopic Surgery']","['postoperative complication rates', 'shorter incision length', 'intraoperative outcomes, pain intensity, postoperative recovery, pathologic outcomes, and long-term outcomes', 'VAS scores', 'intraoperative complication', 'early morbidity rate']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",200.0,0.740949,"The SILS group showed shorter incision length [median (IQR), 4 (3.5-5) vs. 6.6 (6-7.5),  p  < 0.001] and lower VAS scores on the first [median (IQR), 4 (3-5) vs. 4 (4-5),  p  = 0.002] and the second day [median (IQR), 2 (1.5-3) vs. 3 (2-4),  p  < 0.001] after surgery.","[{'ForeName': 'Zijia', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yimei', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Changgang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xianze', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaopin', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}]",Frontiers in oncology,['10.3389/fonc.2021.762147']
2950,34760661,Macintosh laryngoscope versus AMBU King Vision video laryngoscope for endotracheal intubation using a COVID-19 barrier box: A randomized controlled trial.,"Background


Coronavirus disease 2019 (COVID-19) barrier box is being used by health-care workers for protection against aerosol-transmitted infection. Usually, a Macintosh laryngoscope (MC) or a video laryngoscope (VL) is used for endotracheal intubation (ETI). We aimed to determine the most suitable laryngoscope blade in terms of time to ETI, ease of ETI, and the first-pass success rate.
Methods


American Society of Anesthesiologists Grade I and II patients undergoing surgery under general anesthesia were randomized into the MC and the King Vision VL groups in a 1:1 ratio. ETI was performed using either the MC (the MC group) or the King Vision VL (the VL group) with a COVID-19 barrier box. The first-pass intubation success rate, intubation time, and ease of ETI were analyzed.
Results


The first-pass success rate was higher in the MC group ( P  = 0.43). The mean duration of ETI was 33 s and 47 s in the MC group and VL group, respectively. The difference was statistically significant between the groups ( P  = 0.002). The ease of ETI was comparable between the groups ( P  = 0.57), and the Cormack-Lehane grade was significantly different between the groups ( P  = 0.0025).
Conclusion


ETI duration was shorter in the MC group than in the VL group. Hence, a MC can be used along with a COVID-19 barrier box by experienced operators for the prevention of aerosol spread.",2021,"The ease of ETI was comparable between the groups ( P  = 0.57), and the Cormack-Lehane grade was significantly different between the groups ( P  = 0.0025).
",['I and II patients undergoing surgery under general anesthesia'],"['Macintosh laryngoscope versus AMBU King Vision video laryngoscope', 'King Vision VL (the VL group) with a COVID-19 barrier box', 'Macintosh laryngoscope (MC) or a video laryngoscope (VL']","['intubation success rate, intubation time, and ease of ETI', 'success rate', 'Cormack-Lehane grade', 'ease of ETI', 'ETI duration', 'mean duration of ETI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0656116,"The ease of ETI was comparable between the groups ( P  = 0.57), and the Cormack-Lehane grade was significantly different between the groups ( P  = 0.0025).
","[{'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Sahoo', 'Affiliation': 'Department of Trauma and Emergency, AIIMS, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesiology and Critical Care, AIIMS, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Chitta Ranjan', 'Initials': 'CR', 'LastName': 'Mohanty', 'Affiliation': 'Department of Trauma and Emergency, AIIMS, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Hansda', 'Affiliation': 'Department of Trauma and Emergency, AIIMS, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Jyotiranjan', 'Initials': 'J', 'LastName': 'Sahoo', 'Affiliation': 'Department of Community Medicine, IMS and SUM Hospital, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Ajitesh', 'Initials': 'A', 'LastName': 'Sahu', 'Affiliation': 'Department of Trauma and Emergency, AIIMS, Bhubaneswar, Odisha, India.'}]",International journal of critical illness and injury science,['10.4103/ijciis.ijciis_34_21']
2951,34760651,"Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study.","Objective


To compare efficacy, safety, and cost-effectiveness of sertaconazole (2%) and luliconazole (1%) cream in patients with dermatophytoses.
Materials and Methods


Sixty-four patients with tinea corporis and tinea cruris infections were enrolled in this single-center, randomized, open-label, parallel study. Following inclusion and exclusion criteria, patients were randomly divided into two treatment groups and received either sertaconazole 2% cream applied topically twice daily for 4 weeks and luliconazole 1% cream once daily for 2 weeks. At follow-up, efficacy was assessed clinically using 4-point physician global assessment (PGA) scale, composite score, and mycologically by KOH mount. Safety was assessed by monitoring adverse drug events at each visit.
Results


The primary efficacy variables including changes in pruritus, erythema, vesicle, and desquamation (4-point PGA) were significantly ( P  < 0.0001) improved in both the groups, at the end of treatment. There was a significant reduction in mean total composite score (pruritus, erythema, vesicle, and desquamation) after the end of treatment in the sertaconazole group ( P  = 0.0002) compared to the luliconazole group. Both the groups showed equal negative mycological assessment. Both the study drugs were well tolerated. Only one patient in the sertaconazole group showed allergic contact dermatitis.
Conclusion


Sertaconazole was better than luliconazole in relieving signs and symptoms during the study and follow-up period, but cost-effectiveness wise, luliconazole was better than sertaconazole.",2021,"There was a significant reduction in mean total composite score (pruritus, erythema, vesicle, and desquamation) after the end of treatment in the sertaconazole group ( P  = 0.0002) compared to the luliconazole group.","['patients with tinea corporis and tinea cruris infections', 'patients with dermatophytoses']","['sertaconazole and luliconazole cream', 'sertaconazole', 'luliconazole', 'luliconazole (1%) cream', 'sertaconazole 2% cream applied topically twice daily for 4 weeks and luliconazole 1% cream']","['tolerated', 'changes in pruritus, erythema, vesicle, and desquamation (4-point PGA', 'mean total composite score (pruritus, erythema, vesicle, and desquamation', 'equal negative mycological assessment', 'Safety', 'allergic contact dermatitis', 'efficacy, safety, and cost-effectiveness', '4-point physician global assessment (PGA) scale, composite score, and mycologically by KOH mount']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040252', 'cui_str': 'Tinea corporis'}, {'cui': 'C0040253', 'cui_str': 'Tinea of perianal region'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0074391', 'cui_str': 'sertaconazole'}, {'cui': 'C3693180', 'cui_str': 'luliconazole Topical Cream'}, {'cui': 'C1956280', 'cui_str': 'luliconazole'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0333262', 'cui_str': 'Vesicle'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162820', 'cui_str': 'Allergic contact dermatitis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C0181909', 'cui_str': 'Mount'}]",64.0,0.0154063,"There was a significant reduction in mean total composite score (pruritus, erythema, vesicle, and desquamation) after the end of treatment in the sertaconazole group ( P  = 0.0002) compared to the luliconazole group.","[{'ForeName': 'Ganesh N', 'Initials': 'GN', 'LastName': 'Dakhale', 'Affiliation': 'Department of Pharmacology, AIIMS, Nagpur, Maharashtra, India.'}, {'ForeName': 'Ashish V', 'Initials': 'AV', 'LastName': 'Gupta', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Jayesh I', 'Initials': 'JI', 'LastName': 'Mukhi', 'Affiliation': 'Department of Dermato-Venereo-Leprology, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Mrunalini V', 'Initials': 'MV', 'LastName': 'Kalikar', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}]",Perspectives in clinical research,['10.4103/picr.PICR_24_19']
2952,34761039,The of effect of partnership-based education on adherence to the treatment plans in open heart surgery.,"BACKGROUND


Adherence to the treatment plans is one of the most effective conducts to prevent and reduce postoperative side effects. Partnership-based education is one of the most efficient ways to shape health behaviors. The aim of the present study was to determine the effect of partnership-based education on adherence to the treatment plans in open heart surgery.
MATERIALS AND METHODS


This quasi-experimental study was conducted in 2019-2020 on the patients undergoing open heart surgery in Tehran (Capital of Iran). Sampling was done in one educational hospital. A total of 86 patients and their caregivers participated in the study. Sampling was done nonrandomly by tossing a coin, and patients were allocated into the odd week in the intervention group and the even week in the control group ( n  = 43 in each group), and data were collected before and after intervention using the Treatment Adherence Questionnaire concerning dietary, physical activity, and medication aspects. The educational intervention was carried out after the pretest analysis in five 20-45 min sessions (two individual and three group educations). Data were analyzed with Chi-square, independent  t -test, and paired  t -test using SPSS 19 at a significance level of  P  < 0.05.
RESULTS


Patients and caregivers in both groups did not have a significant difference in terms of demographic variables ( P  > 0. 05). In addition, there was no significant difference in the mean of dietary, physical activity, and medication plans before the intervention in both groups; however, after the intervention, the mean of the three aspects in the intervention group was significantly higher than that of control ( P  < 0.001).
CONCLUSION


Implementing partnership-based education with participation of patients and caregivers is influential in improving patients' adherence to the treatment plans and it is recommended as a clinical dynamic educational strategy.",2021,"In addition, there was no significant difference in the mean of dietary, physical activity, and medication plans before the intervention in both groups; however, after the intervention, the mean of the three aspects in the intervention group was significantly higher than that of control ( P  < 0.001).
","['2019-2020 on the patients undergoing open heart surgery in Tehran (Capital of Iran', '86 patients and their caregivers participated in the study', 'open heart surgery']",['partnership-based education'],"['demographic variables', 'mean of dietary, physical activity, and medication plans']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]",86.0,0.0141743,"In addition, there was no significant difference in the mean of dietary, physical activity, and medication plans before the intervention in both groups; however, after the intervention, the mean of the three aspects in the intervention group was significantly higher than that of control ( P  < 0.001).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Bahramnezhad', 'Affiliation': 'Department of Critical Care Nursing, School of Nursing and Midwifery, Nursing and Midwifery Care Research Centre, Spiritual Health Group, Research Center of Quran, Hadith and Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Sanaie', 'Affiliation': 'Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alun C', 'Initials': 'AC', 'LastName': 'Jackson', 'Affiliation': 'Australian Centre for Heart Health, Melbourne Australia.'}, {'ForeName': 'Esmail', 'Initials': 'E', 'LastName': 'Shariati', 'Affiliation': 'Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Foroozan', 'Initials': 'F', 'LastName': 'Atashzadeh-Shoorideh', 'Affiliation': 'Department of Psychiatric Nursing and Management, School of Nursing and Midwifery, Shahid Labbafinezhad Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_1463_20']
2953,34761014,Mobile-application intervention on physical activity of pregnant women in Iran during the COVID-19 epidemic in 2020.,"BACKGROUND


Considering the low level of physical activity in pregnant women in the COVID-19 pandemic period, and on the other hand, the benefits of mobile application (mobile app) learning, we decided to conduct a study to determine the impact of educational intervention based on mobile app on physical activity in pregnant women.
MATERIALS AND METHODS


The present study was quasi-experimental and examined 93 pregnant women aged 16-20 weeks of gestation. Sampling was done on pregnant women participating in the childbirth preparation classes in Isfahan. We used the validated and reliable questionnaire including perceived benefits, perceived barriers, perceived enjoyment, perceived social support, and Pregnancy Physical Activity Questionnaire. The intervention was based on mobile app, and the content of the application contained 12 main domains such as description of physical activity and benefits and barriers of exercise in the pregnancy, different types of proper pregnancy exercise, planning for exercise, and different types of exercise. Finally, data were analyzed using SPSS20, and the Chi-square test, independent  t -test Paired  t -test were employed. The significance level was considered to be <0.05.
RESULTS


The results showed that, after the intervention based on mobile app, the mean score of perceived benefits and enjoyment were significantly higher than before the intervention in the intervention group. Finally, total mean score of physical activity significantly increased in the intervention group, while the change decreased in the control group.
CONCLUSION


The results indicated that the use of mobile app can be used to promote physical activity in pregnant women. Therefore, it is recommended that mobile app education should apply with face-to-face classes in health centers for physical activity in pregnant women in the pandemic situation.",2021,"Finally, total mean score of physical activity significantly increased in the intervention group, while the change decreased in the control group.
","['pregnant women', 'pregnant women in Iran during the COVID-19 epidemic in 2020', '93 pregnant women aged 16-20 weeks of gestation', 'pregnant women participating in the childbirth preparation classes in Isfahan']","['Mobile-application intervention', 'barriers of exercise in the pregnancy, different types of proper pregnancy exercise, planning for exercise, and different types of exercise']","['physical activity', 'perceived benefits, perceived barriers, perceived enjoyment, perceived social support, and Pregnancy Physical Activity Questionnaire', 'mean score of perceived benefits and enjoyment', 'total mean score of physical activity']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0150169', 'cui_str': 'Childbirth preparation'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",93.0,0.0152092,"Finally, total mean score of physical activity significantly increased in the intervention group, while the change decreased in the control group.
","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Kiani', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Asiyeh', 'Initials': 'A', 'LastName': 'Pirzadeh', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_56_21']
2954,34760995,Impact of fan therapy during exercise on breathlessness and recovery time in patients with COPD: a pilot randomised controlled crossover trial.,"Background


Patients with COPD reduce physical activity to avoid the onset of breathlessness. Fan therapy can reduce breathlessness at rest, but the efficacy of fan therapy during exercise remains unknown in this population. The aim of the present study was to investigate 1) the effect of fan therapy on exercise-induced breathlessness and post-exercise recovery time in patients with COPD and 2) the acceptability of fan therapy during exercise; and 3) to assess the reproducibility of any observed improvements in outcome measures.
Methods


A pilot single-centre, randomised, controlled, crossover open (nonmasked) trial (clinicaltrials.gov NCT03137524) of fan therapy  versus  no fan therapy during 6-min walk test (6MWT) in patients with COPD and a modified Medical Research Council (mMRC) dyspnoea score ≥2. Breathlessness intensity was quantified before and on termination of the 6MWT, using the numerical rating scale (NRS) (0-10). Post-exertional recovery time was measured, defined as the time taken to return to baseline NRS breathlessness score. Oxygen saturation and heart rate were measure pre- and post-6MWT.
Results


14 patients with COPD completed the trial per protocol (four male, 10 female; median (interquartile range (IQR)) age 66.50 (60.75 to 73.50) years); mMRC dyspnoea 3 (2 to 3)). Fan therapy resulted in lower exercise-induced breathlessness (ΔNRS; Δ modified Borg scale) (within-individual differences in medians (WIDiM) -1.00, IQR -2.00 to -0.50; p<0.01; WIDiM -0.25, IQR -2.00 to 0.00; p=0.02), greater distance walked (metres) during the 6MWT (WIDiM 21.25, IQR 12.75 to 31.88; p<0.01), and improved post-exertional breathlessness (NRS) recovery time (WIDiM -10.00, IQR -78.75 to 50.00; p<0.01). Fan therapy was deemed to be acceptable by 92% of participants.
Conclusion


Fan therapy was acceptable and provided symptomatic relief to patients with COPD during exercise. These data will inform larger pilot studies and efficacy studies of fan therapy during exercise.",2021,"Fan therapy resulted in lower exercise-induced breathlessness (ΔNRS; Δ modified Borg scale) (within-individual differences in medians (WIDiM) -1.00, IQR -2.00 to -0.50; p<0.01; WIDiM -0.25, IQR -2.00 to 0.00; p=0.02), greater distance walked (metres) during the 6MWT (WIDiM 21.25, IQR 12.75 to 31.88; p<0.01), and improved post-exertional breathlessness (NRS) recovery time (WIDiM -10.00, IQR -78.75 to 50.00; p<0.01).","['14 patients with COPD completed the trial per protocol (four male, 10 female; median (interquartile range (IQR)) age 66.50 (60.75 to 73.50) years); mMRC dyspnoea 3 (2 to 3', 'patients with COPD and 2', 'patients with COPD and a modified Medical Research Council (mMRC) dyspnoea score ≥2', 'patients with COPD during exercise', 'patients with COPD']","['Fan therapy', 'fan therapy  versus  no fan therapy during 6-min walk test (6MWT']","['exercise-induced breathlessness and post-exercise recovery time', 'time taken to return to baseline NRS breathlessness score', 'post-exertional breathlessness (NRS) recovery time', 'lower exercise-induced breathlessness', 'Oxygen saturation and heart rate', 'Post-exertional recovery time', 'breathlessness and recovery time', 'Breathlessness intensity', 'symptomatic relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]","[{'cui': 'C0441039', 'cui_str': 'Fan'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",14.0,0.0941348,"Fan therapy resulted in lower exercise-induced breathlessness (ΔNRS; Δ modified Borg scale) (within-individual differences in medians (WIDiM) -1.00, IQR -2.00 to -0.50; p<0.01; WIDiM -0.25, IQR -2.00 to 0.00; p=0.02), greater distance walked (metres) during the 6MWT (WIDiM 21.25, IQR 12.75 to 31.88; p<0.01), and improved post-exertional breathlessness (NRS) recovery time (WIDiM -10.00, IQR -78.75 to 50.00; p<0.01).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Long', 'Affiliation': ""Dept of Physiotherapy, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Cartwright', 'Affiliation': 'School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Reilly', 'Affiliation': ""Dept of Physiotherapy, King's College Hospital NHS Foundation Trust, London, UK.""}]",ERJ open research,['10.1183/23120541.00211-2021']
2955,34760994,4-week daily airway clearance using oscillating positive-end expiratory pressure  versus  autogenic drainage in bronchiectasis patients: a randomised controlled trial.,"Background


Airway clearance is a fundamental component of bronchiectasis care. Lung clearance index (LCI) is a measurement of ventilation inhomogeneity. Its responsiveness to long-term airway clearance is unknown. We aimed to compare two methods of daily airway clearance over 4 weeks: autogenic drainage (AD) and oscillating positive airway pressure (oPEP), and to determine effects of airway clearance on LCI and clinical outcomes.
Methods


Adults with bronchiectasis naive to airway clearance were randomised to daily airway clearance with either AD or oPEP. Difference in LCI as primary outcome, spirometry, sputum volume and purulence, and quality of life were at randomisation and after 4 weeks of airway clearance.
Results


51 patients (32 women and 19 men, mean age 66.2±12.8 years) were randomised and 49 completed the study (25 AD and 24 oPEP). The LCI and forced expiratory volume in 1 s did not change between visits between groups (difference between groups 0.02), nor between visits in either group. Sputum quantity decreased in 12 out of 24 (50%) of the oPEP group, and in six out of 25 (24%) of the AD group (p=0.044). The ""treatment burden"" worsened or was unchanged in 70% of participants randomised to AD and 55% randomised to oPEP (p=0.038).
Conclusion


Sputum quantity decreased in more participants randomised to oPEP group after 1 month of daily airway clearance, with a better treatment burden. The effects of 4 weeks of airway clearance on LCI were not significant in either treatment group.",2021,"The LCI and forced expiratory volume in 1 s did not change between visits between groups (difference between groups 0.02), nor between visits in either group.","['bronchiectasis patients', 'Adults with bronchiectasis naive to airway clearance', '51 patients (32 women and 19 men, mean age 66.2±12.8\u2005years']","['daily airway clearance over 4\u2005weeks: autogenic drainage (AD) and oscillating positive airway pressure (oPEP', '4-week daily airway clearance using oscillating positive-end expiratory pressure  versus  autogenic drainage', 'oPEP', 'daily airway clearance with either AD or oPEP']","['Lung clearance index (LCI', 'spirometry, sputum volume and purulence, and quality of life', 'LCI and forced expiratory volume', 'Sputum quantity']","[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0454507', 'cui_str': 'Autogenic pulmonary drainage'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0231990', 'cui_str': 'Lung clearance index'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0425514', 'cui_str': 'Sputum volume'}, {'cui': 'C0854358', 'cui_str': 'Purulence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",,0.166368,"The LCI and forced expiratory volume in 1 s did not change between visits between groups (difference between groups 0.02), nor between visits in either group.","[{'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Livnat', 'Affiliation': 'Pediatric Pulmonology, Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Naama', 'Initials': 'N', 'LastName': 'Yaari', 'Affiliation': 'Dept of Physical Therapy, Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Stein', 'Affiliation': 'Dept of Community Medicine and Epidemiology, Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Bentur', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Moneera', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': ""Pediatric Pulmonology and CF Center, The Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel.""}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Harel', 'Affiliation': 'Pulmonology Institute, Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Yochai', 'Initials': 'Y', 'LastName': 'Adir', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Shteinberg', 'Affiliation': 'Cystic Fibrosis Center, Carmel Medical Center, Haifa, Israel.'}]",ERJ open research,['10.1183/23120541.00426-2021']
2956,34760978,"Commentary on ""Effect of green-Mediterranean diet on intrahepatic fat: the DIRECT PLUS randomised controlled trial"".",,2021,,[],['green-Mediterranean diet'],[],[],"[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]",[],,0.0895115,,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Baratta', 'Affiliation': 'Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Pastori', 'Affiliation': 'Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Ben', 'Affiliation': 'Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy.'}]",Hepatobiliary surgery and nutrition,['10.21037/hbsn-21-280']
2957,34760951,External Counterpulsation Improves Angiogenesis by Preserving Vascular Endothelial Growth Factor-A and Vascular Endothelial Growth Factor Receptor-2 but Not Regulating MicroRNA-92a Expression in Patients With Refractory Angina.,"Objective:  External counterpulsation (ECP) provides long-term benefits of improved anginal frequency and exercise tolerance in patients with refractory angina (RA). This is postulated as a result of improved angiogenesis and endothelial function through an increase in shear stress. Angiogenesis is mainly represented by vascular endothelial growth factor-A (VEGF-A) and its receptor, vascular endothelial growth factor receptor-2 (VEGFR-2). The microRNA-92a (miR-92a) is a flow-sensitive miRNA that regulates atherosclerosis and angiogenesis in response to shear stress. Thus, ECP beneficial effect might be achieved through interaction between VEGF-A, VEGFR-2, and miR-92a. This study aims to evaluate the ECP effect on VEGF-A, VEGFR-2, and miR-92a in patients with RA in a sham-controlled manner.  Methods:  This was a randomized sham-controlled trial, enrolling 50 patients with RA who have coronary artery disease (CAD). Participants were randomized (1:1 ratio) to 35 sessions of either ECP ( n  = 25) or sham ( n  = 25), each session lasting for 1 h. Plasma levels of VEGF-A and VEGFR-2 were assayed by the ELISA technique. The quantitative reverse transcription-polymerase chain reaction (qRT-PCR) was performed to measure miR-92a circulating levels in plasma.  Result:  External counterpulsation significantly preserved VEGF-A and VEGFR-2 level compared to sham [ΔVEGF-A: 1 (-139 to 160) vs.-136 (-237 to 67) pg/ml,  p  = 0.026; ΔVEGFR-2: -171(-844 to +1,166) vs. -517(-1,549 to +1,407) pg/ml,  p  = 0.021, respectively]. Circulating miR-92a increased significantly in ECP [5.1 (4.2-6.4) to 5.9 (4.8-6.4), p < 0.001] and sham [5.2 (4.1-9.4) to 5.6 (4.8-6.3),  p  = 0.008] post-intervention. The  fold changes  tended to be higher in ECP group, although was not statistically different from sham [ fold changes  ECP = 4.6 (0.3-36.5) vs. sham 2.8 (0-15),  p  = 0.33)].  Conclusion:  External counterpulsation improved angiogenesis by preserving VEGF-A and VEGFR-2 levels. Both ECP and sham increased miR-92a significantly, yet the changes were not different between the two groups. (Study registered on www.clinicaltrials.gov, no: NCT03991871, August 8, 2019, and received a grant from the National Health Research and Development of Ministry of Health of Indonesia, No: HK.02.02/I/27/2020).",2021,"External counterpulsation significantly preserved VEGF-A and VEGFR-2 level compared to sham [ΔVEGF-A: 1 (-139 to 160) vs.-136 (-237 to 67) pg/ml,  p  = 0.026; ΔVEGFR-2: -171(-844 to +1,166) vs. -517(-1,549 to +1,407) pg/ml,  p  = 0.021, respectively].","['patients with RA in a sham-controlled manner', 'Patients With Refractory Angina', 'patients with refractory angina (RA', '50 patients with RA who have coronary artery disease (CAD']","['ECP', 'External counterpulsation (ECP']","['Circulating miR-92a', 'anginal frequency and exercise tolerance', 'Vascular Endothelial Growth Factor-A and Vascular Endothelial Growth Factor', 'Plasma levels of VEGF-A and VEGFR-2', 'ECP effect on VEGF-A, VEGFR-2, and miR-92a', 'miR-92a', 'VEGF-A and VEGFR-2 level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0741032', 'cui_str': 'Refractory angina'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C0010217', 'cui_str': 'External counterpulsation'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0378796', 'cui_str': 'KDR Tyrosine Kinase'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",50.0,0.213735,"External counterpulsation significantly preserved VEGF-A and VEGFR-2 level compared to sham [ΔVEGF-A: 1 (-139 to 160) vs.-136 (-237 to 67) pg/ml,  p  = 0.026; ΔVEGFR-2: -171(-844 to +1,166) vs. -517(-1,549 to +1,407) pg/ml,  p  = 0.021, respectively].","[{'ForeName': 'Ade Meidian', 'Initials': 'AM', 'LastName': 'Ambari', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Gracia', 'Initials': 'G', 'LastName': 'Lilihata', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Ervan', 'Initials': 'E', 'LastName': 'Zuhri', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Elok', 'Initials': 'E', 'LastName': 'Ekawati', 'Affiliation': 'Division of Cardiovascular Research and Development, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Shoma Adhi', 'Initials': 'SA', 'LastName': 'Wijaya', 'Affiliation': 'Division of Cardiovascular Research and Development, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Bambang', 'Initials': 'B', 'LastName': 'Dwiputra', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Renan', 'Initials': 'R', 'LastName': 'Sukmawan', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Basuni', 'Initials': 'B', 'LastName': 'Radi', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Sofia Mubarika', 'Initials': 'SM', 'LastName': 'Haryana', 'Affiliation': 'Department of Histology and Cell Biology, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Suko', 'Initials': 'S', 'LastName': 'Adiarto', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Dicky A', 'Initials': 'DA', 'LastName': 'Hanafy', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Zamroni', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Elen', 'Initials': 'E', 'LastName': 'Elen', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Arwin S', 'Initials': 'AS', 'LastName': 'Mangkuanom', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Santoso', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Indonesia - National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}]",Frontiers in cardiovascular medicine,['10.3389/fcvm.2021.761112']
2958,34760950,Team-Based Care for Improving Hypertension Management: A Pragmatic Randomized Controlled Trial.,"Objective:  We evaluated the effect on long term blood pressure (BP) of an interprofessional team-based care (TBC) intervention, involving nurses, pharmacists, and physicians, compared to usual care.  Methods:  We conducted a pragmatic randomized controlled study in ambulatory clinics and community pharmacies in Switzerland (ClinicalTrials.gov: NCT02511093). Uncontrolled treated hypertensive patients were randomized to TBC or usual care (UC). In the TBC group, nurses and pharmacists met patients every 6 weeks to measure BP, assess lifestyle, support medication adherence, and provide health education for 6 months. After each visit, they wrote a report to the physician who could adjust antihypertensive therapy. The outcome was the intention-to-treat difference in mean daytime ambulatory blood pressure measurement (ABPM) and control (<135/85 mmHg) at 6 and 12 months.  Results:  Eighty-nine patients (60 men/29 women; mean (SD) age: 61(12) year) were randomized to TBC ( n  = 43) or UC ( n  = 46). At baseline, mean (SD) BP was 144(10)/90(8) mmHg and 147(12)/87(11) mmHg in the TBC and UC groups. At 6 months, the between-groups difference in daytime systolic ABPM was-3 mmHg [95% confidence interval (CI):-10 to +4;  p  = 0.45]; at 12 months, this difference was-7 mmHg [95% CI:-13 to-2;  p  = 0.01]. At 6 months, the between-groups difference in daytime diastolic ABPM was +2 mmHg [95% CI:-1 to +6;  p  = 0.20]; at 12 months, this difference was-2 mmHg [95% CI:-5 to +2; 0.42]. Upon adjustment for baseline covariates including baseline BP, the between-groups differences at 6 and 12 months were maintained. At 6 months, there was no difference in BP control. At 12 months, the TBC group tended to have a better control in systolic BP ( p  = 0.07) but not in diastolic BP ( p  = 0.33).  Conclusion:  While there was not significant effect on BP at 6 months of follow-up, the TBC intervention can help decrease long-term systolic BP among uncontrolled hypertensive patients.",2021,"At 12 months, the TBC group tended to have a better control in systolic BP ( p  = 0.07) but not in diastolic BP ( p  = 0.33).  ","['Hypertension Management', 'ambulatory clinics and community pharmacies in Switzerland (ClinicalTrials.gov', 'uncontrolled hypertensive patients', 'Results:  Eighty-nine patients (60 men/29 women', 'Uncontrolled treated hypertensive patients']","['interprofessional team-based care (TBC) intervention', 'TBC', 'TBC intervention', 'TBC or usual care (UC']","['systolic BP', 'diastolic BP', 'BP control', 'daytime systolic ABPM', 'BP, assess lifestyle, support medication adherence, and provide health education', 'BP', 'mean daytime ambulatory blood pressure measurement (ABPM', 'long term blood pressure (BP', 'decrease long-term systolic BP', 'daytime diastolic ABPM']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0041286', 'cui_str': '7-Deazaadenosine'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}]",,0.171828,"At 12 months, the TBC group tended to have a better control in systolic BP ( p  = 0.07) but not in diastolic BP ( p  = 0.33).  ","[{'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Santschi', 'Affiliation': 'La Source, School of Nursing Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Lausanne, Switzerland.'}, {'ForeName': 'Gregoire', 'Initials': 'G', 'LastName': 'Wuerzner', 'Affiliation': 'Service of Nephrology and Hypertension, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pais', 'Affiliation': 'La Source, School of Nursing Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Lausanne, Switzerland.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Chiolero', 'Affiliation': 'Population Health Laboratory, #PopHealthLab, University of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Schaller', 'Affiliation': 'Cité Générations, Onex, Switzerland.'}, {'ForeName': 'Lyne', 'Initials': 'L', 'LastName': 'Cloutier', 'Affiliation': 'Département des sciences infirmières, Université du Québec à Trois-Rivières, Trois-Rivières, QC, Canada.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Paradis', 'Affiliation': 'School of Population and Global Health, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Burnier', 'Affiliation': 'Service of Nephrology and Hypertension, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}]",Frontiers in cardiovascular medicine,['10.3389/fcvm.2021.760662']
2959,34760843,"Comparison of Different Dosages and Volumes of Triamcinolone in the Treatment of Stenosing Tenosynovitis: A Prospective, Blinded, Randomized Trial.","Background


Stenosing tenosynovitis is a condition due to a size mismatch between the flexor tendons and the first annular pulley. Corticosteroid injection is the mainstay treatment. The purpose of this study is to compare different dosages and volumes of triamcinolone in the treatment of primary stenosing tenosynovitis.
Methods


Patients with primary Quinnell grades 1 or 2 stenosing tenosynovitis were recruited in this prospective, blinded, randomized trial. Patients were randomized into 1 of 2 groups. Group A received 0.25 mL of triamcinolone 40 mg/mL, mixed with 0.25 mL of 1% lidocaine with epinephrine (10 mg of triamcinolone, 0.5 mL in total volume). Group B received 0.5 mL of triamcinolone 40 mg/mL, mixed with 0.5 mL of 1% lidocaine with epinephrine (20 mg of triamcinolone, 1 mL in total volume). Patients were assessed by a blinded hand therapist at 2 and 4 weeks, and by a blinded hand surgeon at 6 weeks. The primary outcome was complete symptom resolution at 6 weeks. Both per-protocol and intention-to-treat analyses were performed.
Results


One hundred ninety-one patients were recruited from 2009 to 2018. Eighty-two and 77 patients had complete data in group A and B, respectively. There was no difference in success rates in complete symptom resolution at 6 weeks between group A (59.8%) and group B (62.3%). The mean visual analogue pain scores on injection were 4.31 ± 2.11 for group A and 4.30 ± 2.09 for group B.
Conclusions


Triamcinolone 10 mg was as effective as 20 mg in the resolution of symptoms of Quinnell grade 1 or 2 stenosing tenosynovitis at 6 weeks.",2021,There was no difference in success rates in complete symptom resolution at 6 weeks between group A (59.8%) and group B (62.3%).,"['One hundred ninety-one patients were recruited from 2009 to 2018', 'Methods\n\n\nPatients with primary Quinnell grades 1 or 2 stenosing tenosynovitis', 'primary stenosing tenosynovitis', 'Stenosing Tenosynovitis']","['Triamcinolone', 'triamcinolone 40 mg/mL, mixed with 0.25 mL of 1% lidocaine with epinephrine', 'triamcinolone 40 mg/mL, mixed with 0.5 mL of 1% lidocaine with epinephrine', 'triamcinolone', 'Corticosteroid injection']","['success rates in complete symptom resolution', 'mean visual analogue pain scores', 'complete symptom resolution']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0039520', 'cui_str': 'Tenosynovitis'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",191.0,0.197278,There was no difference in success rates in complete symptom resolution at 6 weeks between group A (59.8%) and group B (62.3%).,"[{'ForeName': 'Leslie Tze Fung', 'Initials': 'LTF', 'LastName': 'Leung', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of British Columbia, Vancouver, British Columbia, Canada.'}]","Plastic surgery (Oakville, Ont.)",['10.1177/2292550320969643']
2960,34761312,The lessebo effect in randomized controlled trials of rituximab in patients with rheumatoid arthritis: a meta-analysis.,"OBJECTIVE


The goal of this study was to assess the impact of negative expectations associated with receiving a placebo (the lessebo effect) on efficacy outcomes in randomized clinical trials (RCTs) of rituximab in patients with rheumatoid arthritis (RA).
METHODS


We performed a meta-analysis on the American College of Rheumatology 20%, 50%, and 70% (ACR20, 50, 70) response rates in the placebo and active (biosimilar)-controlled groups (reference-pbo and reference-bs) of rituximab showing an insufficient response to methotrexate or tumor necrosis factor. We evaluated the difference in ACR20, 50, 70 response rates between the two groups (reference-bs vs. reference-pbo).
RESULTS


Nine RCTs included a total of 2734 patients with RA. The pooled incidence of ACR20 response rate in the placebo- and active-controlled groups of the rituximab RCTs for RA was 53.1% (95% confidence interval [CI] 49.9-56.3%) and 75.0% (95% CI 71.2-78.4%), respectively. The difference in the ACR20 response rate between the placebo- and active-controlled groups was -20.9% (95% CI -26.9 to 61.9%, p < 0.001). The pooled incidence of ACR50 response rate in the placebo- and active-controlled groups of the rituximab RCTs for RA was 29.0% (95% CI 26.2-32.0%) and 47.4% (95% CI 43.2-51.6%), respectively. The ACR50 response rates were significantly higher in the active-controlled groups than in the placebo-controlled groups (-18.4%; 95% CI -18.4 to -13.4%, p < 0.001). The difference in the ACR70 response rate between the placebo- and active-controlled groups was -14.9% (95% CI -22.2 to -7.6%, p < 0.001). The ACR20, 50, 70 response rates were significantly higher in the active-controlled groups than in the placebo-controlled group.
CONCLUSION


This study shows that the use of a placebo can be associated with a clinically significant reduction in the magnitude of change of the ACR20, 50, 70 response rates in rituximab RCTs for RA. The lessebo effect has potential implications for the development of new treatments and appraisal of current treatment options for RA.",2021,"The ACR20, 50, 70 response rates were significantly higher in the active-controlled groups than in the placebo-controlled group.
","['Nine RCTs included a\xa0total of 2734 patients with RA', 'patients with rheumatoid arthritis', 'patients with rheumatoid arthritis (RA']","['placebo', 'placebo and active (biosimilar)-controlled groups (reference-pbo and reference-bs) of rituximab', 'rituximab']","['ACR20 response rate', 'ACR50 response rates', 'ACR50 response rate', 'ACR70 response rate']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",[],2734.0,0.359327,"The ACR20, 50, 70 response rates were significantly higher in the active-controlled groups than in the placebo-controlled group.
","[{'ForeName': 'Yoon-Kyoung', 'Initials': 'YK', 'LastName': 'Sung', 'Affiliation': 'Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea (Republic of).'}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Rheumatology, Korea University College of Medicine, Seoul, Korea (Republic of). lyhcgh@korea.ac.kr.'}]",Zeitschrift fur Rheumatologie,['10.1007/s00393-021-01126-9']
2961,34766785,A combined laboratory and field test of a smartphone breath alcohol device and blood alcohol concentration estimator to facilitate moderate drinking among young adults.,"OBJECTIVE


Innovative strategies are needed to reduce young adult drinking. Real-time feedback via mobile health (mHealth) technology (e.g., smartphone devices/apps) may facilitate moderate drinking, yet requires evidence of feasibility, acceptability, and usability.
METHOD


Young adults reporting frequent heavy drinking ( N  = 99,  M age  = 23, 51% male) participated in a manualized, brief, motivational interview on recent typical and peak blood alcohol concentration (BAC), then were randomized to use 1 of the 3 forms of technology: (a) smartphone breathalyzer device/app; (b) app that estimates BAC based on factors including sex, weight, number/types of drinks over time; or (c) self-text messaging after each drink. Technologies were tested initially in small-group laboratory alcohol self-administration sessions. Participants then completed a 2-week field test wherein they had free access to all three technologies. Participants reported on usability and acceptability.
RESULTS


Laboratory alcohol self-administration did not differ significantly by technology condition. The smartphone breathalyzer and BAC estimator app had favorable acceptability and usability. Participants used at least one form of technology on 67% of drinking days in the field period. In exploratory analyses, alcohol use during the field period was significantly lower than the baseline including a decrease of nearly one drink per drinking day.
CONCLUSIONS


These findings support the feasibility of research combining lab and field methods to test moderate drinking technologies in young adults. Findings further support the acceptability and usability of these technologies, along with young adults' openness to using them. Exploratory results suggest potential efficacy of combined mobile technology intervention to be tested in subsequent controlled studies. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"RESULTS


Laboratory alcohol self-administration did not differ significantly by technology condition.","['Young adults reporting frequent heavy drinking ( N  = 99,  M age  = 23, 51% male) participated in a', 'young adult drinking', 'young adults']","['smartphone breathalyzer device/app; (b) app that estimates BAC based on factors including sex, weight, number/types of drinks over time; or (c) self-text messaging after each drink', 'combined mobile technology intervention', 'manualized, brief, motivational interview on recent typical and peak blood alcohol concentration (BAC', 'smartphone breath alcohol device and blood alcohol concentration estimator']",['usability and acceptability'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0179415', 'cui_str': 'Breath analyzer'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}, {'cui': 'C0202306', 'cui_str': 'Ethanol measurement, breath'}, {'cui': 'C0401805', 'cui_str': 'Estimator'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0255975,"RESULTS


Laboratory alcohol self-administration did not differ significantly by technology condition.","[{'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Leeman', 'Affiliation': 'Department of Health Education and Behavior.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Berey', 'Affiliation': 'Department of Health Education and Behavior.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Frohe', 'Affiliation': 'Department of Health Education and Behavior.'}, {'ForeName': 'Bonnie H P', 'Initials': 'BHP', 'LastName': 'Rowland', 'Affiliation': 'Department of Health Education and Behavior.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Martens', 'Affiliation': 'Department of Educational, School, and Counseling Psychology.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Fucito', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stellefson', 'Affiliation': 'Department of Health Science.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000780']
2962,34766664,Patient reported self-help strategies and the perceived benefits for managing sub-threshold depressive symptoms: A nested qualitative study of Australian primary care attendees.,"BACKGROUND


Subthreshold depression is common in primary care, but there is little information about the self-help strategies that patients use and the perceived benefits of these.
AIM


This study sought to elicit the self-help strategies that primary care attendees identified as beneficial for the self-management of subthreshold depressive symptoms and the implications for general practitioners.
METHOD


Semi-structured telephone interviews were conducted with 14 people (April-May 2017) from the Target-D randomised controlled trial (RCT). Target-D investigated whether using a patient-centred clinical prediction tool and an e-health platform to match mental health management options to prognosis was beneficial for improving depressive symptoms at 3 months compared to usual care. Interviews were thematically analysed to identify self-help strategies and their perceived benefits.
RESULTS


Four overarching domains for the self-management strategies were identified: social, cognitive, behavioural and restorative. Interviewees reported using strategies across multiple domains, which included undertaking enjoyable, immersive activities, that provided relief from automatic negative thoughts and had a perceived cognitive benefit. Differences in the perceived sense of agency were noted around the self-regulation of mood, which indicated more explicit direction to patient-identified self-help management strategies by general practitioners for some may be of benefit in routine care.
CONCLUSION


Some of the reported self-management strategies aligned with evidence-based approaches such as physical activity and mindfulness for mental health symptom management. These findings can inform low-intensity interventions within stepped care models for mental health in primary care, social prescribing models and, help to guide the management of patients by GPs for subthreshold depression.",2021,"Differences in the perceived sense of agency were noted around the self-regulation of mood, which indicated more explicit direction to patient-identified self-help management strategies by general practitioners for some may be of benefit in routine care.
","['primary care attendees', 'Semi-structured telephone interviews were conducted with 14 people (April-May 2017) from the Target-D randomised controlled trial (RCT', 'Australian primary care attendees']",[],"['depressive symptoms', 'social, cognitive, behavioural and restorative']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0266099,"Differences in the perceived sense of agency were noted around the self-regulation of mood, which indicated more explicit direction to patient-identified self-help management strategies by general practitioners for some may be of benefit in routine care.
","[{'ForeName': 'Anna Kathryn', 'Initials': 'AK', 'LastName': 'Taylor', 'Affiliation': 'School of Medicine, Leeds Institute of Health Sciences, Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Palmer', 'Affiliation': 'The ALIVE National Centre for Mental Health Research Translation, The Department of General Practice, Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Davidson', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, The Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Fletcher', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, The Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Gunn', 'Affiliation': 'The ALIVE National Centre for Mental Health Research Translation, The Department of General Practice, Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia.'}]",Health & social care in the community,['10.1111/hsc.13646']
2963,34767149,Randomized trial of high-dose rectal diclofenac suppository and epinephrine spray on duodenal papilla for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis.,"BACKGROUND AND AIMS


High-dose rectal diclofenac suppository and epinephrine spray on duodenal papilla during endoscopic retrograde cholangiopancreatography (ERCP) may reduce the incidence of post-ERCP pancreatitis. We performed randomized trial to compare the effect of combination of rectal diclofenac and epinephrine spray on papilla (group A) vs. combination of rectal diclofenac with saline spray (group B) for prevention of post-ERCP pancreatitis.
METHODS


We performed a double-blind trial at tertiary care center from April 2018 to May 2020 on 882 patients with naive papilla undergoing ERCP. The patients were randomly assigned to groups, A (n=437) or B (n=445). All patients received a single dose of rectal diclofenac 100 mg within 30 minutes before ERCP; 20 mL of diluted epinephrine 0.02% (group A) or saline (group B) was then sprayed on the duodenal papilla at the end of ERCP. The primary outcome was to compare incidence of post-ERCP pancreatitis (PEP) in two groups.
RESULTS


The groups had similar baseline characteristics. PEP developed in 28 patients in group A (6.4%) and 35 patients in group B (7.9%) (relative risk, 1.1; 95% CI, 0.87-1.39; p=0.401).
CONCLUSION


Our study showed that addition of epinephrine spray on duodenal papilla did not reduce the risk of post-ERCP pancreatitis. There is need for further studies to evaluate the role of different concentrations of epinephrine spray on papilla for prevention of post-ERCP pancreatitis.
TRIAL REGISTRATION


Clinical Trials Registry- India (CTRI/2018/04/013396).",2021,"PEP developed in 28 patients in group A (6.4%) and 35 patients in group B (7.9%) (relative risk, 1.1; 95% CI, 0.87-1.39; p=0.401).
",['tertiary care center from April 2018 to May 2020 on 882 patients with naive papilla undergoing ERCP'],"['rectal diclofenac with saline spray', 'diluted epinephrine 0.02% (group A) or saline', 'rectal diclofenac', 'epinephrine spray', 'Registry- India (CTRI/2018/04/013396', 'rectal diclofenac and epinephrine spray', 'diclofenac suppository and epinephrine spray', 'rectal diclofenac suppository and epinephrine spray', 'endoscopic retrograde cholangiopancreatography (ERCP']","['PEP', 'risk of post-ERCP pancreatitis', 'duodenal papilla for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis', 'incidence of post-ERCP pancreatitis (PEP']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]","[{'cui': 'C0360480', 'cui_str': 'Diclofenac-containing product in rectal dose form'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0227296', 'cui_str': 'Duodenal papilla structure'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",882.0,0.231403,"PEP developed in 28 patients in group A (6.4%) and 35 patients in group B (7.9%) (relative risk, 1.1; 95% CI, 0.87-1.39; p=0.401).
","[{'ForeName': 'Hilal Ahmad', 'Initials': 'HA', 'LastName': 'Dar', 'Affiliation': 'Department of Gastroenterology, Sher- i- Kashmir Institute of Medical Sciences, Srinagar, Kashmir, 190 011, India. drhilaldar@gmail.com.'}, {'ForeName': 'Altaf', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Department of Gastroenterology, Sher- i- Kashmir Institute of Medical Sciences, Srinagar, Kashmir, 190 011, India.'}, {'ForeName': 'Gul', 'Initials': 'G', 'LastName': 'Javid', 'Affiliation': 'Department of Gastroenterology, Sher- i- Kashmir Institute of Medical Sciences, Srinagar, Kashmir, 190 011, India.'}, {'ForeName': 'Mushtaq Ahmad', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Department of Gastroenterology, Sher- i- Kashmir Institute of Medical Sciences, Srinagar, Kashmir, 190 011, India.'}, {'ForeName': 'Bhagat', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'Department of Gastroenterology, Sher- i- Kashmir Institute of Medical Sciences, Srinagar, Kashmir, 190 011, India.'}, {'ForeName': 'Nadeem Ahmad', 'Initials': 'NA', 'LastName': 'Sheikh', 'Affiliation': 'Department of Gastroenterology, Sher- i- Kashmir Institute of Medical Sciences, Srinagar, Kashmir, 190 011, India.'}, {'ForeName': 'Aadil', 'Initials': 'A', 'LastName': 'Ashraf', 'Affiliation': 'Department of Gastroenterology, Sher- i- Kashmir Institute of Medical Sciences, Srinagar, Kashmir, 190 011, India.'}, {'ForeName': 'Sozia', 'Initials': 'S', 'LastName': 'Mohammad', 'Affiliation': 'Department of Microbiology, Sher- i- Kashmir Institute of Medical Sciences, Srinagar, Kashmir, 190 011, India.'}]",Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology,['10.1007/s12664-021-01161-z']
2964,34767148,Comparative efficacy of 0.2% chlorhexidine and 10% Betadine for perioral skin disinfection prior to oral surgical procedures: a clinical trial.,"BACKGROUND


Surgical site infection (SSI) is a possible postoperative complication. Preoperative application of antiseptics on the surgical site can decrease the rate of SSIs.
AIM


This study aimed to compare the efficacy of 0.2% chlorhexidine (CHX) and 10% Betadine (povidone-iodine) for perioral skin disinfection prior to oral surgical procedures.
METHODS


This clinical trial (IRCT20181017041365N1) (registration date: 2019/05/04) evaluated 57 male patients who were randomly selected among those presenting to the Periodontology Department of Ahvaz Jundishapur University. Baseline microbial samples were collected from the perioral skin at the right and left sides of the face in each patient by sterile swabs. Next, the perioral area was disinfected with 10% Betadine in the right side and 0.2% CHX in the left side. Secondary microbial samples were then collected. Wilcoxon matched-pairs signed-ranks and Mann-Whitney test were used to compare the colony counts. The significance level was set at p ≤ 0.05. Data were analyzed with the Stata program, version15.1.
RESULTS


The bacterial colony count was 3147 (314,700) in the Betadine and 3139 (313,900) in the CHX group at baseline (P = 0.86). These values changed to 1196 (119,600) in the Betadine (P < 0.001) and 857 (85,700) in the CHX (P < 0.001) group after disinfection. A significant difference was found in colony count between the CHX and Betadine groups after intervention (P = 0.0001).
CONCLUSION


According to the results, 0.2% CHX has higher antimicrobial efficacy than 10% Betadine for perioral disinfection prior to oral surgical procedures.
TRIAL REGISTRATION


IRCT20181017041365N1. Registered on 2019/05/04.",2021,"A significant difference was found in colony count between the CHX and Betadine groups after intervention (P = 0.0001).
","['57 male patients who were randomly selected among those presenting to the Periodontology Department of Ahvaz Jundishapur University', 'perioral skin disinfection prior to oral surgical procedures']","['Betadine (povidone-iodine', 'chlorhexidine and 10% Betadine', 'CHX', 'Betadine', 'chlorhexidine (CHX', 'CHX and Betadine']","['rate of SSIs', 'antimicrobial efficacy', 'bacterial colony count', 'colony count']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0031098', 'cui_str': 'Periodontics'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0457008', 'cui_str': 'Perioral'}, {'cui': 'C1698034', 'cui_str': 'Skin disinfection'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0524861', 'cui_str': 'Oral surgery'}]","[{'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0368993', 'cui_str': 'Colony count'}]",57.0,0.0686181,"A significant difference was found in colony count between the CHX and Betadine groups after intervention (P = 0.0001).
","[{'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Dorestan', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Ostadian', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Sadaf Sadat', 'Initials': 'SS', 'LastName': 'Mahmoudinezhad', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Farajzadeh Sheikh', 'Affiliation': 'Department of Microbiology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Kooshan', 'Initials': 'K', 'LastName': 'Moradi', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Irish journal of medical science,['10.1007/s11845-021-02850-6']
2965,34767131,Early Trimetazidine Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction Reduces Myocardial Infarction Size.,"PURPOSE


Trimetazidine, a metabolic agent with anti-ischemic effects, was reported to reduce reperfusion injury in animal models. In this randomized double-blind placebo-controlled trial, we investigated the effects of trimetazidine on the reduction of infarction size in patients undergoing revascularization for ST segment elevation myocardial infarction (STEMI).
METHODS


Patients with STEMI randomly received trimetazidine (n = 87) or placebo (n = 86) before primary percutaneous coronary intervention (PCI), and subsequently received oral trimetazidine or placebo for 12 months after reperfusion. The predefined primary endpoint was infarction size on cardiac magnetic resonance (CMR) performed at 7 days after primary PCI. The trial was registered on www.clinicaltrials.gov (registration number: NCT02826616).
RESULTS


The clinical characteristics of the patients in both groups were well-matched at baseline. At 7 days after primary PCI, the percentage and absolute infarction size in the trimetazidine group were significantly smaller than those in the control group (22% ± 12% [n = 74] vs. 27% ± 13% [n = 74], p = 0.011 and 28 ± 18 g [n = 74] vs. 35 ± 19 g [n = 74], p = 0.022, respectively), and the incidence of myocardial microvascular obstruction (MVO) measured by CMR was significantly reduced in the trimetazidine group (29.7% [22/74] vs. 52.7% [39/74], p = 0.005). The myocardial salvage index (MSI) measured by CMR was significantly higher in the trimetazidine group (48% ± 20% vs. 39% ± 20%, p = 0.008). The incidence of readmission due to aggravated heart failure did not differ significantly between the trimetazidine group and the control group (8.0% vs. 14.0%, p = 0.234).
CONCLUSIONS


In patients with STEMI undergoing primary PCI, early trimetazidine before reperfusion reduced myocardial infarction size and MVO, and improved MSI.",2021,"At 7 days after primary PCI, the percentage and absolute infarction size in the trimetazidine group were significantly smaller than those in the control group (22% ± 12% [n = 74] vs. 27% ± 13% [n = 74], p = 0.011 and 28 ± 18 ","['patients with STEMI undergoing primary PCI, early', '\u200974] vs. 35\u2009±\u200919', 'Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction Reduces Myocardial Infarction Size', 'n\u2009=\u200987) or', 'patients undergoing revascularization for ST segment elevation myocardial infarction (STEMI', 'Patients with STEMI randomly received']","['Trimetazidine Therapy', 'trimetazidine', 'placebo (n\u2009=\u200986) before primary percutaneous coronary intervention (PCI), and subsequently received oral trimetazidine or placebo', 'Trimetazidine', 'placebo']","['incidence of readmission due to aggravated heart failure', 'incidence of myocardial microvascular obstruction (MVO) measured by CMR', 'infarction size on cardiac magnetic resonance (CMR', 'myocardial salvage index (MSI) measured by CMR', 'percentage and absolute infarction size', 'myocardial infarction size and MVO, and improved MSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.535991,"At 7 days after primary PCI, the percentage and absolute infarction size in the trimetazidine group were significantly smaller than those in the control group (22% ± 12% [n = 74] vs. 27% ± 13% [n = 74], p = 0.011 and 28 ± 18 ","[{'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Street, Beijing, 100853, China. qiangeng9396@263.net.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'A', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Street, Beijing, 100853, China.'}, {'ForeName': 'Xiaosi', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Street, Beijing, 100853, China.'}, {'ForeName': 'Zichao', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Street, Beijing, 100853, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Street, Beijing, 100853, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Street, Beijing, 100853, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Street, Beijing, 100853, China.'}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Street, Beijing, 100853, China. cyundai@vip.163.com.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-021-07259-y']
2966,34767083,Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Pilot-Randomized Controlled Trial.,"BACKGROUND AND PURPOSE


Post-stroke dysphagia affects almost half of the survivors and severely influences quality of life, thus becoming swallowing rehabilitation of paramount importance. However, there is little adequate evidence on which the best rehabilitative strategy can be. Surface electromyography (sEMG) allows for recording swallowing muscles' activity and provides real time visual feedback, as a biofeedback adjunctive technique to improve treatment outcome. This study aimed to analyze the effectiveness of biofeedback rehabilitation of swallowing through sEMG compared to standard techniques, in post-stroke dysphagia.
METHODS


A pilot-randomized controlled trial included 17 patients diagnosed with post-stroke dysphagia. Nine underwent sEMG-biofeedback rehabilitation; seven controls were submitted to control treatment, one dropout. The primary outcome was the functional oral intake scale (FOIS), secondary outcomes was pharyngeal clearance and safe swallowing, assessed through fiberoptic endoscopic evaluation of swallowing (FEES).
RESULTS


FOIS improved in all patients, regardless of treatment. sEMG-biofeedback rehabilitation led to improvements of the pharyngeal clearance and swallowing safety. The rehabilitative effects appeared stable at 2-months follow-up.
CONCLUSIONS


The application of biofeedback based on sEMG in post-stroke dysphagia patients resulted in an effective rehabilitative technique, in particular for pharyngeal clearance improvements and safe swallowing, thus reducing the risk of aspiration and malnutrition.",2021,"The application of biofeedback based on sEMG in post-stroke dysphagia patients resulted in an effective rehabilitative technique, in particular for pharyngeal clearance improvements and safe swallowing, thus reducing the risk of aspiration and malnutrition.","['Post-stroke Dysphagia', 'post-stroke dysphagia patients', '17 patients diagnosed with post-stroke dysphagia']","['biofeedback rehabilitation of swallowing through sEMG', 'Biofeedback', 'sEMG-biofeedback rehabilitation', 'Surface electromyography (sEMG']","['functional oral intake scale (FOIS), secondary outcomes was pharyngeal clearance and safe swallowing, assessed through fiberoptic endoscopic evaluation of swallowing (FEES', 'rehabilitative effects', 'pharyngeal clearance and swallowing safety', 'FOIS']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0589408', 'cui_str': 'Fiberoptic endoscopic evaluation of swallowing'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",17.0,0.08984,"The application of biofeedback based on sEMG in post-stroke dysphagia patients resulted in an effective rehabilitative technique, in particular for pharyngeal clearance improvements and safe swallowing, thus reducing the risk of aspiration and malnutrition.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Nordio', 'Affiliation': 'IRCCS San Camillo Hospital, Via Alberoni 70, 30126, Venice, Lido di Venezia, Italy. sara.nordio@ospedalesancamillo.net.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Arcara', 'Affiliation': 'IRCCS San Camillo Hospital, Via Alberoni 70, 30126, Venice, Lido di Venezia, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Berta', 'Affiliation': 'IRCCS San Camillo Hospital, Via Alberoni 70, 30126, Venice, Lido di Venezia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dellai', 'Affiliation': 'IRCCS San Camillo Hospital, Via Alberoni 70, 30126, Venice, Lido di Venezia, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Brisotto', 'Affiliation': 'IRCCS San Camillo Hospital, Via Alberoni 70, 30126, Venice, Lido di Venezia, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Koch', 'Affiliation': 'IRCCS San Camillo Hospital, Via Alberoni 70, 30126, Venice, Lido di Venezia, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cazzador', 'Affiliation': 'Otorhinolaryngology Unit, Department of Neurosciences, University of Padua, Via Giustiniani 5, 35128, Padua, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Aspidistria', 'Affiliation': 'Department of Statistical Sciences, University of Padua, Via Cesare Battisti 241, 35121, Padua, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ventura', 'Affiliation': 'Department of Statistical Sciences, University of Padua, Via Cesare Battisti 241, 35121, Padua, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Turolla', 'Affiliation': 'IRCCS San Camillo Hospital, Via Alberoni 70, 30126, Venice, Lido di Venezia, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': ""D'Imperio"", 'Affiliation': 'IRCCS San Camillo Hospital, Via Alberoni 70, 30126, Venice, Lido di Venezia, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Battel', 'Affiliation': 'Unità Operativa Medicina Fisica e Riabilitativa, Ulss 3 Serenissima, Ospedale Civile di Venezia, Castello, 6667, Venice, Italy.'}]",Dysphagia,['10.1007/s00455-021-10385-2']
2967,34767038,"The Singa-Pacli Trial, Another RCT that Lacks to Encourage the use of DEB BTK.",,2021,,[],[],[],[],[],[],,0.0702522,,"[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van Overhagen', 'Affiliation': 'Haga Teaching Hospital, Els Borst Eilersplein 275, 2545AA, Den Haag, The Netherlands. h.voverhagen@hagaziekenhuis.nl.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-021-02937-8']
2968,34767030,Bone marrow aspirate concentrate injections provide similar results versus viscosupplementation up to 24 months of follow-up in patients with symptomatic knee osteoarthritis. A randomized controlled trial.,"PURPOSE


The purpose of this double-blind randomized controlled trial (RCT) was to compare clinical improvement and radiographic findings up to 2 years of follow-up of a single intra-articular injection of bone marrow aspirate concentrate (BMAC) versus hyaluronic acid (HA) for the treatment of knee osteoarthritis (OA). The hypothesis was that BMAC injection could lead to better clinical and radiographic results compared to viscosupplementation.
METHODS


Patients with bilateral knee OA were randomized to one intra-articular injection of tibial-derived BMAC in one knee and one HA injection in the contralateral knee. Sixty patients were enrolled, and 56 were studied up to the final follow-up (35 men, 21 women, mean age 57.8 ± 8.9 years), for a total of 112 knees. Patients were evaluated before the injection and at 1, 3, 6, 12, and 24 months with the IKDC subjective score, VAS for pain, and the KOOS score. Minimal clinically important difference (MCID), patient treatment judgement, and adverse events were documented, as well as bilateral X-Rays (Rosenberg view) before and after treatment.
RESULTS


No severe adverse events nor differences were reported in terms of mild adverse events (7.1% vs 5.4%, p = ns) and treatment failures (10.7% vs 12.5%, p = ns) in BMAC and HA groups, respectively. The IKDC subjective score improved from baseline to all follow-ups for BMAC (p < 0.0005), while it improved up to 12 months (p < 0.0005) and then decreased at 24 months (p = 0.030) for HA. Compared to HA, BMAC showed a higher improvement for VAS pain at 12 (2.2 ± 2.6 vs 1.7 ± 2.5, p = 0.041) and 24 months (2.2 ± 2.6 vs 1.4 ± 2.8, p = 0.002). The analysis based on OA severity confirmed this difference only in Kellgren-Lawrence 1-2 knees, while comparable results were observed in moderate/severe OA. Radiographic evaluation did not show knee OA deterioration for both treatment groups, without intergroup differences.
CONCLUSION


BMAC did not demonstrate a clinically significant superiority at short-term compared to viscosupplementation, reporting overall comparable results in terms of clinical scores, failures, adverse events, radiographic evaluation, MCID achievement, and patient treatment judgment. However, while HA results decreased over time, BMAC presented more durable results in mild OA knees.
LEVEL OF EVIDENCE


Level I.",2021,"The IKDC subjective score improved from baseline to all follow-ups for BMAC (p < 0.0005), while it improved up to 12 months (p < 0.0005) and then decreased at 24 months (p = 0.030) for HA.","['Sixty patients were enrolled, and 56 were studied up to the final follow-up (35 men, 21 women, mean age 57.8\u2009±\u20098.9\xa0years), for a total of 112 knees', 'knee osteoarthritis (OA', 'patients with symptomatic knee osteoarthritis', 'Patients with bilateral knee OA']","['intra-articular injection of tibial-derived BMAC in one knee and one HA injection', 'bone marrow aspirate concentrate (BMAC) versus hyaluronic acid (HA']","['treatment failures', 'mild adverse events', 'severe adverse events', 'VAS pain', 'IKDC subjective score', 'knee OA deterioration', 'clinical scores, failures, adverse events, radiographic evaluation, MCID achievement, and patient treatment judgment', 'IKDC subjective score, VAS for pain, and the KOOS score', 'Minimal clinically important difference (MCID), patient treatment judgement, and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0857285', 'cui_str': 'Bone marrow aspirate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}]",60.0,0.116449,"The IKDC subjective score improved from baseline to all follow-ups for BMAC (p < 0.0005), while it improved up to 12 months (p < 0.0005) and then decreased at 24 months (p = 0.030) for HA.","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Boffa', 'Affiliation': 'Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, Via Di Barbiano, 1/10, 40136, Bologna, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Di Martino', 'Affiliation': 'Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, Via Di Barbiano, 1/10, 40136, Bologna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Andriolo', 'Affiliation': 'Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, Via Di Barbiano, 1/10, 40136, Bologna, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'De Filippis', 'Affiliation': 'Clinica Mediterranea, Via Orazio 2, 80122, Napoli, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Poggi', 'Affiliation': 'Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, Via Di Barbiano, 1/10, 40136, Bologna, Italy. poggialberto8@gmail.com.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Kon', 'Affiliation': 'Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, 20089, Rozzano, MI, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Zaffagnini', 'Affiliation': 'Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, Via Di Barbiano, 1/10, 40136, Bologna, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Filardo', 'Affiliation': 'Applied and Translational Research (ATR) Center, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-021-06793-4']
2969,34766929,Effects of Acupuncture and Acupressure on Burnout in Health Care Workers: A Randomized Trial.,"BACKGROUND


Health care workers face occupational stressors that may lead to burnout and secondary traumatic stress. Strategies to mitigate the negative psychological impact on frontline workers are urgently needed.
OBJECTIVE


The purpose of this study was to evaluate the effect of auricular acupuncture or acupressure, as compared with ear massage, on anxiety, burnout, and caring capacity in health care workers. Results were stratified on the basis of subject's level of belief in traditional Chinese medicine.
METHODS


This prospective randomized trial with an open, parallel-group design was conducted at a 334-bed Level II pediatric trauma center. Participants were randomized to one of three groups: (1) auricular acupuncture, (2) auricular seed acupressure, or (3) auricular massage. Interventions were delivered over 3 weeks. Self-reported State-Trait Anxiety Inventory (STAI), Professional Quality of Life (ProQOL), and Caring Ability Inventory (CAI) scores were analyzed using a pre-/posttest design. Univariate analysis, Fisher's exact test, and analysis of variance (ANOVA) were performed to assess group differences.
RESULTS


A total of 117 (36%) of 325 eligible participants consented to participate in the study. Seed acupressure treatment (n = 14, 35.9%, one male, 13 females) was associated with a reduction in burnout (ANOVA, p = .04) and secondary traumatic stress (p = .03). This effect remained significant after adjusting for individual pretest scores (ANOVA, p = .05). The studied interventions did not have a significant effect on STAI, ProQOL, or CAI scores.
CONCLUSIONS


Auricular acupressure is a safe, effective, and practical strategy to reduce burnout and secondary traumatic stress and may support health care workers' ability to develop caring relationships with patients and families.",2021,"Seed acupressure treatment (n = 14, 35.9%, one male, 13 females) was associated with a reduction in burnout (ANOVA, p = .04) and secondary traumatic stress (p = .03).","['Health Care Workers', 'A total of 117 (36%) of 325 eligible participants consented to participate in the study', 'health care workers', '334-bed Level II pediatric trauma center']","['auricular acupuncture or acupressure', 'Auricular acupressure', 'Seed acupressure', 'auricular acupuncture, (2) auricular seed acupressure, or (3) auricular massage', 'Acupuncture and Acupressure']","['STAI, ProQOL, or CAI scores', 'Self-reported State-Trait Anxiety Inventory (STAI), Professional Quality of Life (ProQOL), and Caring Ability Inventory (CAI) scores', 'secondary traumatic stress']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0441926', 'cui_str': 'Level II'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}]","[{'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}]",325.0,0.074591,"Seed acupressure treatment (n = 14, 35.9%, one male, 13 females) was associated with a reduction in burnout (ANOVA, p = .04) and secondary traumatic stress (p = .03).","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Afrasiabi', 'Affiliation': ""Emergency Department, UCI Medical Center, Orange, California (Ms Afrasiabi); Acupuncture and Chinese Medicine (Dr McCarty), Nursing Research and Innovation (Drs Hayakawa and Barrows), Emergency Department (Dr Lee and Ms Plouffe), and Nursing Research and Innovation and Trauma Services (Dr Schomberg), Children's Hospital of Orange County, Orange, California; and Open Mind Modalities Inc, Orange, California (Dr McCarty).""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McCarty', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hayakawa', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barrows', 'Affiliation': ''}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Plouffe', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Schomberg', 'Affiliation': ''}]",Journal of trauma nursing : the official journal of the Society of Trauma Nurses,['10.1097/JTN.0000000000000614']
2970,34766930,Effects of Acupuncture and Acupressure on Burnout in Health Care Workers: A Randomized Trial.,,2021,,['Health Care Workers'],['Acupuncture and Acupressure'],[],"[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}]",[],,0.093162,,[],Journal of trauma nursing : the official journal of the Society of Trauma Nurses,['10.1097/JTN.0000000000000622']
2971,34766920,Dietary intake and main food sources of vitamin D and calcium in Colombian urban adults.,"Data on dietary calcium and vitamin D intake from Latin America are scarce. We explored the main correlates and dietary sources of calcium and vitamin D in a probabilistic, population-based sample from Colombia. We studied 1554 participants aged 18 to 75 from five different geographical regions. Dietary intake was assessed employing a 157-item semi-quantitative food frequency questionnaire and national and international food composition tables. Daily vitamin D intake decreased with increasing age, from 230 IU/day in the 18-39 age group to 184 IU/day in the 60-75 age group (p-trend<0.001). Vitamin D intake was positively associated with socioeconomic status (SES) (196 IU/d in lowest vs 234 in highest SES, p-trend<0.001), and with educational level (176 IU/d in lowest vs 226 in highest education level, p-trend<0.001). Daily calcium intake also decreased with age, from 1376 mg/day in the 18-39 age group to 1120 mg/day in the 60-75 age group (p-trend<0.001). Calcium intake was lowest among participants with only elementary education, but the absolute difference in calcium intake between extreme education categories was smaller than for vitamin D (1107 versus 1274 mg/d, p-trend 0.023). Daily calcium intake did not correlate with SES (p-trend=0.74) Eggs were the main source of vitamin D overall, albeit their contribution decreased with increasing age. Dairy products contributed at least 48% of dietary calcium in all subgroups, mostly from cheese-containing traditional foods. SES and education were key correlates of vitamin D and calcium intake. These findings may contribute to shape public health interventions in Latin American countries.",2021,Daily calcium intake did not correlate with SES (p-trend=0.74),"['Colombian urban adults', '1554 participants aged 18 to 75 from five different geographical regions']","['calcium and vitamin D', 'Dietary intake and main food sources of vitamin D and calcium']","['Calcium intake', 'socioeconomic status (SES', 'calcium intake', 'Daily calcium intake', 'Daily vitamin D intake', 'Vitamin D intake', 'educational level']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449416', 'cui_str': 'Source'}]","[{'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0564439', 'cui_str': 'Vitamin D intake'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]",1554.0,0.222125,Daily calcium intake did not correlate with SES (p-trend=0.74),"[{'ForeName': 'Mateo', 'Initials': 'M', 'LastName': 'Amaya-Montoya', 'Affiliation': 'M Amaya-Montoya, Medicina, Universidad de los Andes, Bogota, Colombia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Duarte-Montero', 'Affiliation': 'D Duarte-Montero, Medicina, Universidad de los Andes, Bogota, Colombia.'}, {'ForeName': 'Luz D', 'Initials': 'LD', 'LastName': 'Nieves-Barreto', 'Affiliation': 'L Nieves-Barreto, Medicina, Universidad de los Andes, Bogota, Colombia.'}, {'ForeName': 'Angélica', 'Initials': 'A', 'LastName': 'Montaño-Rodríguez', 'Affiliation': 'A Montaño-Rodríguez, Medicina, Universidad de los Andes, Bogota, Colombia.'}, {'ForeName': 'Eddy C', 'Initials': 'EC', 'LastName': 'Betancourt-Villamizar', 'Affiliation': 'E Betancourt-Villamizar, Team Foods Colombia, Bogota, Colombia.'}, {'ForeName': 'María P', 'Initials': 'MP', 'LastName': 'Salazar-Ocampo', 'Affiliation': 'M Salazar-Ocampo, Medicina, Universidad de los Andes, Bogota, Colombia.'}, {'ForeName': 'Carlos O', 'Initials': 'CO', 'LastName': 'Mendivil', 'Affiliation': 'C Mendivil, Medicina, Universidad de los Andes, Bogota, 110111, Colombia.'}]",Endocrine connections,['10.1530/EC-21-0341']
2972,34766913,A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE.,"BACKGROUND


People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority.
OBJECTIVE


The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains.
METHODS


Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods.
RESULTS


Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F 1,313 =13.38; P<.001), GAD-7 (F 1,313 =5.87; P=.01), RAS (F 1,313 =23.42; P<.001), RSES (F 1,313 =19.28; P<.001), and SDS (F 1,313 =10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3.
CONCLUSIONS


We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467.",2021,"Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F 1,313 =13.38; P<.001), GAD-7 (F 1,313 =5.87; P=.01), RAS (F 1,313 =23.42; P<.001), RSES (F 1,313 =19.28; P<.001), and SDS (F 1,313 =10.73; P=.001).","['individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline', 'Individuals were recruited via the web using Google and Facebook advertisements', 'People with serious mental illness (SMI', '315 individuals from 45 states participated in this study', 'People With Serious Mental Illness']","['Smartphone Intervention', 'active intervention or waitlist control groups', 'smartphone intervention']","['30-day (T2), and 60-day (T3) assessment points', 'GAD-7', ' Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS', 'moderate effect size', 'small effect size', 'Beck Depression Inventory-Second Edition (BDI-II']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}]",,0.228897,"Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F 1,313 =13.38; P<.001), GAD-7 (F 1,313 =5.87; P=.01), RAS (F 1,313 =23.42; P<.001), RSES (F 1,313 =19.28; P<.001), and SDS (F 1,313 =10.73; P=.001).","[{'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Ben-Zeev', 'Affiliation': 'Behavioral Research in Technology and Engineering Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Chander', 'Affiliation': 'Behavioral Research in Technology and Engineering Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Tauscher', 'Affiliation': 'Behavioral Research in Technology and Engineering Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': 'Behavioral Research in Technology and Engineering Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Subigya', 'Initials': 'S', 'LastName': 'Nepal', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, United States.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Doron', 'Affiliation': 'School of Psychology, Interdisciplinary Center, Herzliya, Israel.'}]",Journal of medical Internet research,['10.2196/29201']
2973,34766912,Experiences of Wearable Technology by Persons with Knee Osteoarthritis Participating in a Physical Activity Counseling Intervention: Qualitative Study Using a Relational Ethics Lens.,"BACKGROUND


Current evidence indicates physical activity wearables could support persons with knee osteoarthritis (OA) to be more physically active. However, recent evidence also identifies some persons with arthritis experience guilt or worry while using a wearable if they are not as active as they feel they should be. Questions remain around how persons with knee OA experience benefits or downsides using a wearable in their everyday lives. Better understanding is needed if wearables are to be incorporated in arthritis self-management in ethically aware ways.
OBJECTIVE


Using an ethics lens, we aimed to describe a range of experiences from persons with knee OA who used a wearable during a physical activity counseling intervention study.
METHODS


This is a secondary analysis of qualitative interviews nested within a randomized controlled trial. Guided by phenomenography, we explored the experiences of persons with knee OA following participation in a physical activity counseling intervention that involved using a Fitbit Flex and biweekly phone calls with a study physiotherapist (PT) in an 8-week period. Benefits or downsides experienced in participants' relationships with themselves or the study PT when using the wearable were identified using a relational ethics lens.
RESULTS


Interviews with 21 participants (12 females and 9 males) aged 40 to 82 years were analyzed. Education levels ranged from high school graduates (4/21, 19%) to bachelor's degrees or above (11/21, 52%). We identified 3 categories of description: (1) participants experienced their wearable as a motivating or nagging influence to be more active, depending on how freely they were able to make autonomous choices about physical activity in their everyday lives; (2) some participants felt a sense of accomplishment from seeing progress in their wearable data, which fueled their motivation; (3) for some participants, sharing wearable data helped to build mutual trust in their relationship with the study PT. However, they also expressed there was potential for sharing wearable data to undermine this trust, particularly if this data was inaccurate.
CONCLUSIONS


Findings provide an early glimpse into positive and negative emotional impacts of using a wearable that can be experienced by participants with knee OA when participating in a randomized controlled trial to support physical activity. To our knowledge, this is the first qualitative study that uses a relational ethics lens to explore how persons with arthritis experienced changes in their relationship with a health professional when using a wearable during research participation.",2021,"Benefits or downsides experienced in participants' relationships with themselves or the study PT when using the wearable were identified using a relational ethics lens.
","['persons with knee OA who used a wearable during a physical activity counseling intervention study', 'persons with knee osteoarthritis (OA', 'Persons with Knee Osteoarthritis Participating in a Physical Activity Counseling Intervention', 'Interviews with 21 participants (12 females and 9 males) aged 40 to 82 years']",['physical activity counseling intervention that involved using a Fitbit Flex and biweekly phone calls with a study physiotherapist (PT'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]",[],1.0,0.0436815,"Benefits or downsides experienced in participants' relationships with themselves or the study PT when using the wearable were identified using a relational ethics lens.
","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Leese', 'Affiliation': 'Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'MacDonald', 'Affiliation': 'Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Backman', 'Affiliation': 'Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Townsend', 'Affiliation': 'Arthritis Research Canada, Vancouver, BC, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nimmon', 'Affiliation': 'Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Li', 'Affiliation': 'Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada.'}]",JMIR mHealth and uHealth,['10.2196/30332']
2974,34767321,Secondary Antibiotic Prophylaxis for Latent Rheumatic Heart Disease.,"BACKGROUND


Rheumatic heart disease affects more than 40.5 million people worldwide and results in 306,000 deaths annually. Echocardiographic screening detects rheumatic heart disease at an early, latent stage. Whether secondary antibiotic prophylaxis is effective in preventing progression of latent rheumatic heart disease is unknown.
METHODS


We conducted a randomized, controlled trial of secondary antibiotic prophylaxis in Ugandan children and adolescents 5 to 17 years of age with latent rheumatic heart disease. Participants were randomly assigned to receive either injections of penicillin G benzathine (also known as benzathine benzylpenicillin) every 4 weeks for 2 years or no prophylaxis. All the participants underwent echocardiography at baseline and at 2 years after randomization. Changes from baseline were adjudicated by a panel whose members were unaware of the trial-group assignments. The primary outcome was echocardiographic progression of latent rheumatic heart disease at 2 years.
RESULTS


Among 102,200 children and adolescents who had screening echocardiograms, 3327 were initially assessed as having latent rheumatic heart disease, and 926 of the 3327 subsequently received a definitive diagnosis on the basis of confirmatory echocardiography and were determined to be eligible for the trial. Consent or assent for participation was provided for 916 persons, and all underwent randomization; 818 participants were included in the modified intention-to-treat analysis, and 799 (97.7%) completed the trial. A total of 3 participants (0.8%) in the prophylaxis group had echocardiographic progression at 2 years, as compared with 33 (8.2%) in the control group (risk difference, -7.5 percentage points; 95% confidence interval, -10.2 to -4.7; P<0.001). Two participants in the prophylaxis group had serious adverse events that were attributable to receipt of prophylaxis, including one episode of a mild anaphylactic reaction (representing <0.1% of all administered doses of prophylaxis).
CONCLUSIONS


Among children and adolescents 5 to 17 years of age with latent rheumatic heart disease, secondary antibiotic prophylaxis reduced the risk of disease progression at 2 years. Further research is needed before the implementation of population-level screening can be recommended. (Funded by the Thrasher Research Fund and others; GOAL ClinicalTrials.gov number, NCT03346525.).",2021,"A total of 3 participants (0.8%) in the prophylaxis group had echocardiographic progression at 2 years, as compared with 33 (8.2%) in the control group (risk difference, -7.5 percentage points; 95% confidence interval, -10.2 to -4.7; P<0.001).","['916 persons, and all underwent randomization; 818 participants were included in the modified intention-to-treat analysis, and 799 (97.7%) completed the trial', 'Ugandan children and adolescents 5 to 17 years of age with latent rheumatic heart disease', 'Latent Rheumatic Heart Disease', 'children and adolescents 5 to 17 years of age with latent rheumatic heart disease, secondary antibiotic prophylaxis reduced the risk of disease progression at 2 years', '102,200 children and adolescents who had screening echocardiograms, 3327 were initially assessed as having latent rheumatic heart disease, and 926 of the 3327 subsequently received a definitive diagnosis on the basis of confirmatory echocardiography and were determined to be eligible for the trial']","['secondary antibiotic prophylaxis', 'penicillin G benzathine (also known as benzathine benzylpenicillin', 'Echocardiographic screening']","['mild anaphylactic reaction', 'serious adverse events', 'echocardiographic progression of latent rheumatic heart disease at 2 years', 'echocardiographic progression']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0030829', 'cui_str': 'benzathine benzylpenicillin'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0439234', 'cui_str': 'year'}]",102200.0,0.514049,"A total of 3 participants (0.8%) in the prophylaxis group had echocardiographic progression at 2 years, as compared with 33 (8.2%) in the control group (risk difference, -7.5 percentage points; 95% confidence interval, -10.2 to -4.7; P<0.001).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Beaton', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Emmy', 'Initials': 'E', 'LastName': 'Okello', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Joselyn', 'Initials': 'J', 'LastName': 'Rwebembera', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Grobler', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Engelman', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Alepere', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Canales', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'DeWyer', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lwabi', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Mirabel', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Ana O', 'Initials': 'AO', 'LastName': 'Mocumbi', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Murali', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Nakitto', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ndagire', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Maria C P', 'Initials': 'MCP', 'LastName': 'Nunes', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Isaac O', 'Initials': 'IO', 'LastName': 'Omara', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sarnacki', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Scheel', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Zimmerman', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Liesl', 'Initials': 'L', 'LastName': 'Zühlke', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Karthikeyan', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sable', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Steer', 'Affiliation': ""From Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati School of Medicine - both in Cincinnati (A.B.); Uganda Heart Institute (E.O., J.R., J.A., P.L., M.N., E.N., I.O.O.), and the Department of Medicine, Makerere University (E.O.) - both in Kampala, Uganda; Children's National Hospital, Washington, DC (L.C., M. Murali, R.S., C.A.S.); Murdoch Children's Research Institute (A.G., D.E., A.C.S.), and Melbourne Children's Global Health, Royal Children's Hospital (D.E., A.C.S.), Melbourne, and Telethon Kids Institute, Perth Children's Hospital, University of Western Australia, Perth (J.C.) - all in Australia; Virginia Tech Carilion School of Medicine, Roanoke, VA (A.D.W.); Assistance Publique-Hôpitaux de Paris, Université de Paris, and Cardio-Oncologie, Hôpital Européen Georges-Pompidou - both in Paris (M. Mirabel); Instituto Nacional de Saúde, Maputo, Mozambique (A.O.M.); Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (M.C.P.N.); Emory University School of Medicine, Atlanta (A.S.); Green Lane Paediatric and Congenital Cardiac Service, Starship Children's Hospital, Auckland, New Zealand (N.W.); Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.Z.); the Division of Paediatric Cardiology, Department of Paediatrics, Red Cross War Memorial Children's Hospital, and the Division of Cardiology, Department of Medicine, Groote Schuur Hospital - both in Cape Town, South Africa (L.Z.); and All India Institute of Medical Sciences, New Delhi, India (G.K.).""}]",The New England journal of medicine,['10.1056/NEJMoa2102074']
2975,34767246,Cognitive training program improves cognitive ability and daily living ability in elderly patients with mild cognitive impairment.,"BACKGROUND


Mild cognitive impairment (MCI) is a clinical syndrome of mild memory or other cognitive impairment without dementia and is a clinical transition state between normal aging and dementia. Careful and meticulous nursing intervention can improve the clinical symptoms of MCI and delay the progression of the disease.
AIMS


This research aimed to evaluate the efficacy of cognitive function training interventions in elderly patients with MCI.
METHODS


106 patients were randomized into the intervention group or the control group. They received conventional nursing intervention and those in the intervention group received additional cognitive training program for 6 weeks. The Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), activities of daily living (ADL) scales, and Barthel index (BI) were evaluated before and 6 weeks after the intervention, as well as the serum levels of S100β and neuron-specific enolase (NSE) at two time points.
RESULTS


After intervention, the MMSE scores and MoCA scores in both groups were significantly increased and the score in the intervention group was significantly higher. In the intervention group, the performance of conventional nursing intervention and cognitive training program significantly increased the scores of ADL and BI (p < 0.001). The serum levels of NSE and S100β in the intervention group were significantly lower.
DISCUSSION


The performance of cognitive training program alleviated the brain tissue damage in elderly patients with MCI.
CONCLUSIONS


The performance of cognitive training program in elderly patients with MCI improved their cognitive ability and daily living ability.",2021,"After intervention, the MMSE scores and MoCA scores in both groups were significantly increased and the score in the intervention group was significantly higher.","['elderly patients with mild cognitive impairment', 'elderly patients with MCI', '106 patients']","['cognitive function training interventions', 'conventional nursing intervention', 'cognitive training program', 'conventional nursing intervention and cognitive training program', 'additional cognitive training program', 'Cognitive training program']","['brain tissue damage', 'serum levels of S100β and neuron-specific enolase (NSE', 'Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), activities of daily living (ADL) scales, and Barthel index (BI', 'MMSE scores and MoCA scores', 'serum levels of NSE and S100β', 'scores of ADL and BI', 'cognitive ability and daily living ability']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0440746', 'cui_str': 'Brain tissue'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",106.0,0.0101619,"After intervention, the MMSE scores and MoCA scores in both groups were significantly increased and the score in the intervention group was significantly higher.","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Tian', 'Affiliation': 'Department of Rehabilitation, Cangzhou Central Hospital, Cangzhou, 061000, Hebei Province, China. qingmei_2002@163.com.'}, {'ForeName': 'Yujuan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Rehabilitation, Cangzhou Central Hospital, Cangzhou, 061000, Hebei Province, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Cangzhou Central Hospital, Cangzhou, 061000, Hebei Province, China.'}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Rehabilitation, Cangzhou Central Hospital, Cangzhou, 061000, Hebei Province, China.'}, {'ForeName': 'Yingwen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Magnetic Resonance, Cangzhou Central Hospital, Cangzhou, 061000, Hebei Province, China.'}, {'ForeName': 'Deqiang', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Computer Tomography, Cangzhou Central Hospital, Cangzhou, 061000, Hebei Province, China.'}]",Aging clinical and experimental research,['10.1007/s40520-021-02015-6']
2976,34767227,[Placebo in pain therapy].,,2021,,[],['Placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.317973,,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Schmitz', 'Affiliation': 'Schmerzmedizin und Schmerzpsychologie, Klinik und Poliklinik für Anästhesiologie, Martinistrasse 52, 20246, Hamburg, Germany. schmitz@uke.de.'}]",MMW Fortschritte der Medizin,['10.1007/s15006-021-0404-8']
2977,34767181,Efficacy of Dupilumab in Atopic Dermatitis: The Patient's Perspective.,"INTRODUCTION


Atopic dermatitis (AD), a predominantly type 2 inflammatory skin disease, affects approximately 2-5% of adults, with a high burden of disease. In moderate-to-severe AD, lesions can be extensive and pruritus intense with patients experiencing skin pain, sleep and mental health disturbances, and diminished quality of life (QoL).
METHODS


The objective of this study was to evaluate the efficacy of dupilumab for the treatment of AD from the patients' perspective using patient-reported outcome data from four clinical trials (CHRONOS, SOLO 1&2, and CAFÉ) in patients (N = 1553) receiving either the approved 300 mg q2w dupilumab with/without topical corticosteroids (TCS) dose or control (placebo or placebo + TCS). Patient Global Assessment of Disease Status (PGADS) was used to measure patients' well-being and Patient Global Assessment of Treatment Effect (PGATE) was used to measure treatment efficacy. Patients were asked ""Considering all the ways in which your eczema affects you, indicate how well you are doing"" to assess their perception of well-being and ""How would you rate the way your eczema responded to the study medication?"" to assess their perception of treatment effect. Possible responses for both metrics included poor, fair, good, very good, and excellent.
RESULTS


In all four studies, a significantly higher proportion of dupilumab-treated patients reported ""Good""/""Very Good""/""Excellent"" disease status from week 2 through study end versus control (CHRONOS, 52 weeks: 69.8% vs. 25.1%; SOLO 1&2, 16 weeks: 59.5% vs. 24.6%; CAFÉ, 16 weeks: 84.1% vs. 45.4%; all P < 0.0001), and significantly more dupilumab-treated patients reported ""Good""/""Very Good""/""Excellent"" treatment efficacy versus control (CHRONOS: 72.6% vs. 24.8%; SOLO 1&2: 65.0% vs. 21.1%; CAFÉ, 16 weeks: 85.0% vs. 36.1%; all P < 0.0001).
CONCLUSION


Adult patients with AD perceived that dupilumab with/without concomitant TCS was highly efficacious and improved overall disease status and well-being as early as week 2 and throughout treatment periods up to 1 year. Video Abstract (MP4 90521 kb).",2021,"CONCLUSION


Adult patients with AD perceived that dupilumab with/without concomitant TCS was highly efficacious and improved overall disease status and well-being as early as week 2 and throughout treatment periods up to 1 year.","['Atopic Dermatitis', ""patients' perspective using patient-reported outcome data from four clinical trials (CHRONOS, SOLO\xa01&2, and CAFÉ) in patients (N\u2009=\u20091553) receiving either the approved 300""]","['Dupilumab', 'dupilumab', 'mg q2w dupilumab with/without', 'topical corticosteroids (TCS) dose or control (placebo or placebo\u2009+\u2009TCS']","['Patient Global Assessment of Disease Status (PGADS', 'overall disease status', 'quality of life (QoL']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.131522,"CONCLUSION


Adult patients with AD perceived that dupilumab with/without concomitant TCS was highly efficacious and improved overall disease status and well-being as early as week 2 and throughout treatment periods up to 1 year.","[{'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'de Bruin-Weller', 'Affiliation': 'Department of Dermatology and Allergology, National Expertise Center of Atopic Dermatitis, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Chih-Ho', 'Initials': 'CH', 'LastName': 'Hong', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Surrey, BC, Canada.'}, {'ForeName': 'Esther Serra', 'Initials': 'ES', 'LastName': 'Baldrich', 'Affiliation': 'Hospital Sant Pau, Universitat Autonoma Barcelona, Barcelona, Spain.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Ettler', 'Affiliation': 'University Hospital Hradec Kralove, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Sierka', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Dimittri', 'Initials': 'D', 'LastName': 'Delevry', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA. Ana.Rossi@sanofi.com.'}]",Dermatology and therapy,['10.1007/s13555-021-00621-w']
2978,33867500,The Impact of 6-Month Land versus Water Walking on Cerebrovascular Function in the Aging Brain.,"INTRODUCTION


To examine the hypothesis that exercise training induces adaptation in cerebrovascular function, we recruited 63 older adults (62 ± 7 yr, 46 females) to undertake 24 wk of either land walking or water walking, or participate in a nonexercise control group. This is the first multi-interventional study to perform a comprehensive assessment of cerebrovascular function in response to longer term (6-month) training interventions, including water-based exercise, in older healthy individuals.
METHODS


Intracranial blood flow velocities (middle cerebral artery (MCAv) and posterior cerebral artery) were assessed at rest and in response to neurovascular coupling, hypercapnic reactivity, and cerebral autoregulation.
RESULTS


We observed no change in resting MCAv in response to either training intervention (pre vs post, mean (95% confidence interval), land walking: 65 (59-70) to 63 (57-68) cm·s-1, P = 0.33; water walking: 63 (58-69) to 61 (55-67) cm·s-1, P = 0.92) compared with controls and no change in neurovascular coupling (land walking: P = 0.18, water walking: P = 0.17). There was a significant but modest improvement in autoregulatory normalized gain after the intervention in the water-walking compared with the land-walking group (P = 0.03). Hypercapnic MCAv reactivity was not different based on exercise group (land: P = 087, water: P = 0.83); however, when data were pooled from the exercise groups, increases in fitness were correlated with decreases in hypercapnic reactivity (r2 = 0.25, P = 0.003).
CONCLUSIONS


Although exercise was not associated with systematic changes across multiple domains of cerebrovascular function, our data indicate that exercise may induce modest changes in autoregulation and CO2 reactivity. These findings should encourage further studies of the longer-term implications of exercise training on cerebrovascular health.",2021,"Hypercapnic MCAv reactivity was not different based on exercise group (land: P = 087, water: P = 0.83); however, when data were pooled from the exercise groups, increases in fitness were correlated with decreases in hypercapnic reactivity (r2 = 0.25, P = 0.003).
","['older healthy individuals', '63 older adults (62 ± 7 yr, 46 females) to undertake 24 wk of either land walking or water walking, or participate in a nonexercise control group']","['exercise training', '6-Month Land versus Water Walking']","['Intracranial blood flow velocities (middle cerebral artery (MCAv) and posterior cerebral artery', 'Hypercapnic MCAv reactivity', 'land walking', 'autoregulation and CO2 reactivity', 'Cerebrovascular Function', 'cerebrovascular health', 'hypercapnic reactivity', 'autoregulatory normalized gain']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0149576', 'cui_str': 'Structure of posterior cerebral artery'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",63.0,0.00872584,"Hypercapnic MCAv reactivity was not different based on exercise group (land: P = 087, water: P = 0.83); however, when data were pooled from the exercise groups, increases in fitness were correlated with decreases in hypercapnic reactivity (r2 = 0.25, P = 0.003).
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, AUSTRALIA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, AUSTRALIA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Maslen', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, AUSTRALIA.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': ''}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': ''}, {'ForeName': 'Carmela F', 'Initials': 'CF', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of Western Australia, Perth, WA, AUSTRALIA.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, AUSTRALIA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Science, University of British Columbia, Kelowna, British Columbia, CANADA.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Carter', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002685']
2979,34480880,Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial.,"BACKGROUND


The devastating Coronavirus disease (COVID-19) pandemic is associated with a high prothrombotic state. It is unclear if the coagulation abnormalities occur because of the direct effect of SARS-CoV-2 or indirectly by the cytokine storm and endothelial damage or by a combination of mechanisms. There is a clear indication of in-hospital pharmacological thromboprophylaxis for every patient with COVID-19 after bleed risk assessment. However, there is much debate regarding the best dosage regimen, and there is no consensus on the role of extended thromboprophylaxis.
DESIGN


This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg once daily for 35 ± 4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization. The composite efficacy endpoint is a combination of symptomatic VTE, VTE-related death, VTE detected by bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35 ± 4 posthospital discharge and symptomatic arterial thromboembolism (myocardial infarction, nonhemorrhagic stroke, major adverse limb events, and cardiovascular death) up to day 35 ± 4 posthospital discharge. The key safety outcome is the incidence of major bleeding according to ISTH criteria.
SUMMARY


The MICHELLE trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice. 1 .",2021,This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg once daily for 35 ± 4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization.,"['COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization', 'Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with']","['rivaroxaban', 'rivaroxaban ThErapy']","['safety and efficacy', 'symptomatic VTE, VTE-related death, VTE detected by bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35 ± 4 posthospital discharge and symptomatic arterial thromboembolism (myocardial infarction, nonhemorrhagic stroke, major adverse limb events, and cardiovascular death']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0677490', 'cui_str': 'Angiogram pulmonary'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3544094', 'cui_str': 'Arterial thromboembolism'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3805136', 'cui_str': 'Nonhaemorrhagic stroke'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.211969,This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg once daily for 35 ± 4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization.,"[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ramacciotti', 'Affiliation': 'Science Valley Research Institute, Santo André, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil. Electronic address: eduardoramacciotti@gmail.com.'}, {'ForeName': 'Leandro Barile', 'Initials': 'LB', 'LastName': 'Agati', 'Affiliation': 'Science Valley Research Institute, Santo André, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Calderaro', 'Affiliation': 'Interdisciplinary Medicine in Cardiology Unit Heart Institute (InCor)- University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Giuliano Giova', 'Initials': 'GG', 'LastName': 'Volpiani', 'Affiliation': 'Science Valley Research Institute, Santo André, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil.'}, {'ForeName': 'Caroline Candida Carvalho', 'Initials': 'CCC', 'LastName': 'de Oliveira', 'Affiliation': 'Science Valley Research Institute, Santo André, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil.'}, {'ForeName': 'Valéria Cristina Resende', 'Initials': 'VCR', 'LastName': 'Aguiar', 'Affiliation': 'Science Valley Research Institute, Santo André, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rodrigues', 'Affiliation': 'Science Valley Research Institute, Santo André, São Paulo, Brazil.'}, {'ForeName': 'Marcone Lima', 'Initials': 'ML', 'LastName': 'Sobreira', 'Affiliation': 'Universidade Estadual Paulista (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Edwaldo Edner', 'Initials': 'EE', 'LastName': 'Joviliano', 'Affiliation': 'Hospital das Clínicas de Ribeirão Preto, São Paulo University Medical School (USP), Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Dusilek', 'Affiliation': 'Hospital do Rocio, Campo Largo, Paraná, Brazil.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Itinose', 'Affiliation': 'Hospital do Rocio, Campo Largo, Paraná, Brazil.'}, {'ForeName': 'Rogério Aparecido', 'Initials': 'RA', 'LastName': 'Dedivitis', 'Affiliation': 'Irmandade da Santa Casa da Misericórdia de Santos, São Paulo, Brazil.'}, {'ForeName': 'André Sementilli', 'Initials': 'AS', 'LastName': 'Cortina', 'Affiliation': 'Irmandade da Santa Casa da Misericórdia de Santos, São Paulo, Brazil.'}, {'ForeName': 'Suzanna Maria Viana', 'Initials': 'SMV', 'LastName': 'Sanches', 'Affiliation': 'Hospital Ana Neri, Salvador, Bahia, Brazil.'}, {'ForeName': 'Nara Franzin', 'Initials': 'NF', 'LastName': 'de Moraes', 'Affiliation': 'Hospital Municipal de Barueri, São Paulo, Brazil.'}, {'ForeName': 'Paulo Fernando Guimarães Morando Marzocchi', 'Initials': 'PFGMM', 'LastName': 'Tierno', 'Affiliation': 'Hospital Municipal de Barueri, São Paulo, Brazil.'}, {'ForeName': 'André Luiz Malavasi Longo', 'Initials': 'ALML', 'LastName': 'de Oliveira', 'Affiliation': ""São Paulo State Public Women's Health Reference Center, São Paulo, Brazil.""}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Tachibana', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, S.P., Brazil.'}, {'ForeName': 'Rodrigo Caruso', 'Initials': 'RC', 'LastName': 'Chate', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, S.P., Brazil.'}, {'ForeName': 'Marcus Vinícius Barbosa', 'Initials': 'MVB', 'LastName': 'Santos', 'Affiliation': 'Heart Institute (InCor)- University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Bruno Bezerra de Menezes', 'Initials': 'BBM', 'LastName': 'Cavalcante', 'Affiliation': 'Institute of Teaching and Research Hapvida, Fortaleza, CE, Brazil.'}, {'ForeName': 'Ricardo Cesar Rocha', 'Initials': 'RCR', 'LastName': 'Moreira', 'Affiliation': 'Hospital Nossa Senhora das Graças, Curitiba, Brazil.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Chiann', 'Affiliation': 'Department of Statistics, Institute of Mathematics and Statistics, University of Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Tafur', 'Affiliation': 'Northshore University Health System, Chicago, IL.'}, {'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Spyropoulos', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell and the Feinstein Institutes for Medical Research, Manhasset, NY.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2021.08.016']
2980,34385543,Immunomodulation by durvalumab and pomalidomide in patients with relapsed/refractory multiple myeloma.,"This study sought to understand how the programmed death ligand 1 (PD-L1) inhibitor durvalumab and the immunomodulatory agent pomalidomide regulate immune cell activation and function in patients with relapsed/refractory (RR) multiple myeloma (MM). Immunologic changes in peripheral blood and bone marrow of patients treated with durvalumab as monotherapy or in combination with pomalidomide with/without dexamethasone were characterized by assessing subsets of immune cells and gene signatures to understand the immunomodulatory effect of the treatment. Soluble PD-L1 levels were elevated at screening in patients with RRMM but did not correlate with response to durvalumab combination therapy. Immune cell subsets were increased in peripheral blood during treatment with durvalumab and pomalidomide, and combination therapy induced significant gene expression changes in the MM tumor microenvironment versus durvalumab alone. Estimation of cell populations based on RNA sequencing data revealed increased monocytes, neutrophils, and natural killer cells with the combination therapy, but not with durvalumab alone. Additionally, multiplex immunofluorescence of bone marrow demonstrated that immune populations were different in responders versus nonresponders to durvalumab plus pomalidomide with dexamethasone therapy. Overall, durvalumab effectively blocked soluble PD-L1; however, durvalumab monotherapy was not associated with immunologic changes, which were observed with combination therapy.",2021,"Immune cell subsets were increased in peripheral blood during treatment with durvalumab and pomalidomide, and combination therapy induced significant gene expression changes in the MM tumor microenvironment versus durvalumab alone.","['patients with relapsed/refractory (RR) multiple myeloma (MM', 'patients with relapsed/refractory multiple myeloma']","['durvalumab as monotherapy', 'durvalumab and pomalidomide', 'dexamethasone']","['Immune cell subsets', 'Soluble PD-L1 levels', 'monocytes, neutrophils, and natural killer cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}]",,0.0329676,"Immune cell subsets were increased in peripheral blood during treatment with durvalumab and pomalidomide, and combination therapy induced significant gene expression changes in the MM tumor microenvironment versus durvalumab alone.","[{'ForeName': 'Mary H', 'Initials': 'MH', 'LastName': 'Young', 'Affiliation': 'Bristol Myers Squibb, 3401 Princeton Pike, Princeton, NJ, 08648, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Pietz', 'Affiliation': 'Bristol Myers Squibb, 3401 Princeton Pike, Princeton, NJ, 08648, USA. Greg.Pietz@bms.com.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Whalen', 'Affiliation': 'Bristol Myers Squibb, 3401 Princeton Pike, Princeton, NJ, 08648, USA.'}, {'ForeName': 'Wilbert', 'Initials': 'W', 'LastName': 'Copeland', 'Affiliation': 'Bristol Myers Squibb, 3401 Princeton Pike, Princeton, NJ, 08648, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Thompson', 'Affiliation': 'Bristol Myers Squibb, 3401 Princeton Pike, Princeton, NJ, 08648, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Fox', 'Affiliation': 'Bristol Myers Squibb, 3401 Princeton Pike, Princeton, NJ, 08648, USA.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Newhall', 'Affiliation': 'Bristol Myers Squibb, 3401 Princeton Pike, Princeton, NJ, 08648, USA.'}]",Scientific reports,['10.1038/s41598-021-95902-x']
2981,34504129,Spacetime in the brain: rapid brain network reorganization in visual processing and recovery.,"Functional connectivity networks (FCN) are the physiological basis of brain synchronization to integrating neural activity. They are not rigid but can reorganize under pathological conditions or during mental or behavioral states. However, because mental acts can be very fast, like the blink of an eye, we now used the visual system as a model to explore rapid FCN reorganization and its functional impact in normal, abnormal and post treatment vision. EEG-recordings were time-locked to visual stimulus presentation; graph analysis of neurophysiological oscillations were used to characterize millisecond FCN dynamics in healthy subjects and in patients with optic nerve damage before and after neuromodulation with alternating currents stimulation and were correlated with visual performance. We showed that rapid and transient FCN synchronization patterns in humans can evolve and dissolve in millisecond speed during visual processing. This rapid FCN reorganization is functionally relevant because disruption and recovery after treatment in optic nerve patients correlated with impaired and recovered visual performance, respectively. Because FCN hub and node interactions can evolve and dissolve in millisecond speed to manage spatial and temporal neural synchronization during visual processing and recovery, we propose ""Brain Spacetime"" as a fundamental principle of the human mind not only in visual cognition but also in vision restoration.",2021,"This rapid FCN reorganization is functionally relevant because disruption and recovery after treatment in optic nerve patients correlated with impaired and recovered visual performance, respectively.",[],['Functional connectivity networks (FCN'],['visual performance'],[],"[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}]",,0.0538236,"This rapid FCN reorganization is functionally relevant because disruption and recovery after treatment in optic nerve patients correlated with impaired and recovered visual performance, respectively.","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Institute of Medical Psychology, Medical Faculty, Otto-von-Guericke University of Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Bernhard A', 'Initials': 'BA', 'LastName': 'Sabel', 'Affiliation': 'Institute of Medical Psychology, Medical Faculty, Otto-von-Guericke University of Magdeburg, Magdeburg, Germany. bernhard.sabel@med.ovgu.de.'}]",Scientific reports,['10.1038/s41598-021-96971-8']
2982,34543276,Assessment of small-intestine permeability in healthy Nigerian children is altered by urinary volume and voiding status.,"OBJECTIVE


This study aimed to uncover the effect of voided urinary volume on small intestine permeability ratios in healthy children.
METHODS


We assessed small intestine permeability in 155 apparently healthy children, aged 3-5 years old, without any visible symptoms of disease, in a rural, malaria-endemic setting in Nigeria, using a multi-sugar test solution, comprising lactulose, sucrose, mannitol, and rhamnose. Children were categorized into low urinary volume (LV) and high urinary volume (HV), based on the volume of urine voided per kg body weight per hour. LV children voided less than 25th percentile of the total population, while HV children voided greater than 75th percentile of the total population. Urinary volume excreted over a 90-minute period after administration of the test solution was measured, and differences in sugar ratios were compared between children with high (HV) and low urinary volumes (LV), as well as between children who voided (VC) or who were not able to void (NVC) before administration of the test solution.
RESULTS


Urinary mannitol and rhamnose recovery were 44% (p = 0.002) and 77% (p<0.001) higher in HV children compared to LV children respectively, while urinary lactulose recovery was 34% lower (p = 0.071). There was no difference in urinary sucrose recovery between groups (p = 0.74). Lactulose-mannitol ratio, lactulose-rhamnose ratio and sucrose-rhamnose ratio were all significantly higher in children in the LV group compared to children in the HV group (p<0.001). In a multiple regression analysis, urinary volume and voiding status combined, explained 13%, 23% and 7% of the variation observed in lactulose-mannitol, lactulose-rhamnose and sucrose-rhamnose ratios, respectively.
CONCLUSION


Sugar permeability ratios vary significantly with total urinary volume in multi-sugar small-intestine permeability tests. Voiding status before sugar administration appears to influence lactulose recovery, lactulose-rhamnose and sucrose-rhamnose ratios independently of total urinary volume. Evidence from this study suggests the need to take urinary volume into account when conducting multi-sugar small-intestine permeability tests.",2021,"RESULTS


Urinary mannitol and rhamnose recovery were 44% (p = 0.002) and 77% (p<0.001) higher in HV children compared to LV children respectively, while urinary lactulose recovery was 34% lower (p = 0.071).","['155 apparently healthy children, aged 3-5 years old, without any visible symptoms of disease, in a rural, malaria-endemic setting in Nigeria, using a multi-sugar test solution, comprising', 'healthy Nigerian children', 'healthy children']","['voided urinary volume', 'lactulose, sucrose, mannitol, and rhamnose']","['urinary volume and voiding status combined', 'small intestine permeability', 'sugar ratios', 'Lactulose-mannitol ratio, lactulose-rhamnose ratio and sucrose-rhamnose ratio', 'urinary sucrose recovery', 'low urinary volume (LV) and high urinary volume (HV', 'small intestine permeability ratios', 'urinary lactulose recovery', 'Urinary mannitol and rhamnose recovery', 'Urinary volume excreted']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1287298', 'cui_str': 'Urine volume finding'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0035417', 'cui_str': 'rhamnose'}]","[{'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0429243', 'cui_str': 'Small intestine permeability'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0035417', 'cui_str': 'rhamnose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",155.0,0.0519681,"RESULTS


Urinary mannitol and rhamnose recovery were 44% (p = 0.002) and 77% (p<0.001) higher in HV children compared to LV children respectively, while urinary lactulose recovery was 34% lower (p = 0.071).","[{'ForeName': 'Ibukun', 'Initials': 'I', 'LastName': 'Afolami', 'Affiliation': 'Department of Human Nutrition, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Folake Olukemi', 'Initials': 'FO', 'LastName': 'Samuel', 'Affiliation': 'Department of Human Nutrition, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Mwangi', 'Affiliation': 'Department of Human Nutrition, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Oderinde', 'Affiliation': 'Department of Human Nutrition, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Diepeveen-de Bruin', 'Affiliation': 'Department of Human Nutrition, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Melse-Boonstra', 'Affiliation': 'Department of Human Nutrition, Wageningen University & Research, Wageningen, the Netherlands.'}]",PloS one,['10.1371/journal.pone.0253436']
2983,34767655,Effect of concurrent strength and endurance training on run performance and biomechanics: a randomised controlled trial.,"This parallel-groups randomised controlled trial investigated the effect of concurrent strength and endurance (CSE) training on running performance, biomechanics, and muscle activity during overground running. Thirty moderately-trained distance runners were randomly assigned to 10-weeks CSE training (n = 15; 33.1 ± 7.5 years) or a control group (n = 15; 34.2 ± 8.2 years). Participants ran ≥ 30 km per week and had no experience with strength training. The primary outcome measure was two-kilometre run time. Secondary outcome measures included lower limb sagittal plane biomechanics and muscle activity during running (3.89 m·s -1  and maximal sprinting); maximal aerobic capacity (V̇O 2  max); running economy; and, body composition. CSE training improved two-kilometre run time (mean difference (MD): -11.3 s [95% CI -3.7, -19.0]; p = 0.006) and time to exhaustion during the V̇O 2  max running test (MD 59.1 s [95% CI 8.58, 109.62]; p = 0.024). The CSE training group also reduced total body fat (MD: -1.05 kg [95% CI -0.21, -1.88]; p = 0.016) while total body mass and lean body mass were unchanged. Hip joint angular velocity during the early swing phase of running at 3.89 m·s -1  was the only biomechanical or muscle activity variable that significantly changed following CSE training. CSE training is beneficial for running performance, but changes in running biomechanics and muscle activity may not be contributing factors to the performance improvement. Future research should consider other possible mechanisms and the effect of CSE training on biomechanics and muscle activity during prolonged running under fatigued conditions.",2021,"The CSE training group also reduced total body fat (MD: -1.05 kg [95% CI -0.21, -1.88]; p = 0.016) while total body mass and lean body mass were unchanged.",['Thirty moderately-trained distance runners'],"['CSE training', 'concurrent strength and endurance training', 'concurrent strength and endurance (CSE) training', 'strength training']","['two-kilometre run time', 'total body mass and lean body mass', 'running performance, biomechanics, and muscle activity', 'total body fat', 'lower limb sagittal plane biomechanics and muscle activity during running (3.89 m·s -1  and maximal sprinting); maximal aerobic capacity (V̇O 2  max); running economy; and, body composition', 'time to exhaustion', 'Hip joint angular velocity', 'run performance and biomechanics']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0439198', 'cui_str': 'km'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",,0.0572725,"The CSE training group also reduced total body fat (MD: -1.05 kg [95% CI -0.21, -1.88]; p = 0.016) while total body mass and lean body mass were unchanged.","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Trowell', 'Affiliation': 'Centre for Sport Research, Deakin University, Australia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Fox', 'Affiliation': 'Centre for Sport Research, Deakin University, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Saunders', 'Affiliation': 'Centre for Sport Research, Deakin University, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Queensland, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bonacci', 'Affiliation': 'Centre for Sport Research, Deakin University, Australia.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.14092']
2984,34767652,A Prospective Study of Filgrastim Pharmacokinetics in Morbidly Obese Patients Compared to Non-Obese Controls.,"INTRODUCTION


Filgrastim is a human granulocyte colony-stimulating factor (G-CSF). There is limited data on dosing filgrastim in obesity. The objective of this study was to compare filgrastim pharmacokinetic parameters for morbidly obese and non-obese patients after a single subcutaneous dose of filgrastim dosed per actual body weight.
METHODS


This prospective, matched-pair study (NCT01719432) included patients ≥18 years of age, receiving filgrastim at 5 mcg/kg with a weight >190% of their ideal body weight (IBW) for ""morbidly obese"" patients or within 80-124% of IBW for matched control patients. The control group was prospectively matched for age (within 10 years), degree of neutropenia, and gender. Filgrastim doses were not rounded to vial size, to allow more accurate assessment of exposure. Blood samples were collected at 0 (prior to dose), 2, 4, 6, 8, 12, and 24 hours after the first subcutaneous administration of filgrastim.
RESULTS


A total of 30 patients were enrolled in this prospective pharmacokinetic study, with 15 patients assigned to each arm. Non-compartmental analysis showed that the systemic clearance (Cl) was 0.111 ± 0.041 mL/min in the morbidly obese group versus 0.124 ± 0.045 mL/min in the non-obese group (p=0.44). Additionally, the mean area under the curve (AUC 0-24h  ) was 49.3 ± 13.9 ng/mL x min in the morbidly obese group versus 46.3 ± 16.8 ng/mL x min in the non-obese group (p=0.6). No differences were seen in maximum concentrations (C max  ) between the two groups (morbidly obese: 48.1 ± 14.7 ng/mL vs. non-obese: 49.2 ± 20.7 ng/mL (p=0.87)). The morbidly obese group had a numerically higher, but not statistically significant, increase in time to maximum concentration (T max  ) compared to the non-obese group (544 ± 145 min vs 436 ± 156 min (p=0.06), respectively).
CONCLUSION


Calculating subcutaneous filgrastim doses using actual body weight appears to produce similar systemic exposure in morbidly obese and non-obese patients with severe neutropenia.",2021,No differences were seen in maximum concentrations (C max  ) between the two groups (morbidly obese: 48.1 ± 14.7 ng/mL vs. non-obese: 49.2 ± 20.7 ng/mL (p=0.87)).,"['Morbidly Obese Patients', '30 patients', 'patients ≥18 years of age, receiving filgrastim at 5 mcg/kg with a weight >190% of their ideal body weight (IBW) for ""morbidly obese"" patients or within 80-124% of IBW for matched control patients', 'morbidly obese and non-obese patients with severe neutropenia', 'morbidly obese and non-obese patients after a single subcutaneous dose of']","['filgrastim', 'Filgrastim', 'Filgrastim Pharmacokinetics']","['systemic clearance (Cl', 'time to maximum concentration (T max  ', 'Blood samples', 'filgrastim pharmacokinetic parameters', 'maximum concentrations (C max  ']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C1627892', 'cui_str': 'ug/kg'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0421272', 'cui_str': 'Ideal body weight'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",30.0,0.0211699,No differences were seen in maximum concentrations (C max  ) between the two groups (morbidly obese: 48.1 ± 14.7 ng/mL vs. non-obese: 49.2 ± 20.7 ng/mL (p=0.87)).,"[{'ForeName': 'Aaron W', 'Initials': 'AW', 'LastName': 'Stewart', 'Affiliation': 'Department of Pharmacy, West Virginia University Hospital, Morgantown, West Virginia, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Shillingburg', 'Affiliation': 'Department of Pharmacy, West Virginia University Hospital, Morgantown, West Virginia, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Petros', 'Affiliation': 'School of Pharmacy, West Virginia University, Morgantown, West Virginia, USA.'}, {'ForeName': 'Sijin', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Biostatistics, West Virginia University, Morgantown, West Virginia, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Piktel', 'Affiliation': 'West Virginia University Cancer Institute, Robert C. Byrd Health Sciences Center, West Virginia University, Morgantown, West Virginia, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Moses', 'Affiliation': 'West Virginia University Cancer Institute, Robert C. Byrd Health Sciences Center, West Virginia University, Morgantown, West Virginia, USA.'}, {'ForeName': 'Laura F', 'Initials': 'LF', 'LastName': 'Gibson', 'Affiliation': 'West Virginia University Cancer Institute, Robert C. Byrd Health Sciences Center, West Virginia University, Morgantown, West Virginia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Craig', 'Affiliation': 'West Virginia University Cancer Institute, Robert C. Byrd Health Sciences Center, West Virginia University, Morgantown, West Virginia, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Cumpston', 'Affiliation': 'Department of Pharmacy, West Virginia University Hospital, Morgantown, West Virginia, USA.'}]",Pharmacotherapy,['10.1002/phar.2646']
2985,34767581,A social norms approach intervention to address misperceptions of anti-vaccine conspiracy beliefs amongst UK parents.,"Anti-vaccine conspiracy beliefs among parents can reduce vaccination intentions. Parents' beliefs in anti-vaccine conspiracy theories are also related to their perceptions of other parents' conspiracy beliefs. Further, research has shown that parents hold misperceptions of anti-vaccine conspiracy belief norms: UK parents over-estimate the anti-vaccine conspiracy beliefs of other parents. The present study tested the effectiveness of a Social Norms Approach intervention, which corrects misperceptions using normative feedback, to reduce UK parents' anti-vaccine conspiracy beliefs and increase vaccination intentions. At baseline, 202 UK parents of young children reported their personal belief in anti-vaccine conspiracy theories, future intentions to vaccinate, and their perceptions of other UK parents' beliefs and intentions. Participants were then randomly assigned to a normative feedback condition (n = 89) or an assessment-only control condition (n = 113). The normative feedback compared participants' personal anti-vaccine conspiracy beliefs and perceptions of other UK parents' beliefs with actual normative belief levels. Parents receiving the normative feedback showed significantly reduced personal belief in anti-vaccine conspiracy beliefs at immediate post-test. As hypothesised, changes in normative perceptions of anti-vaccine conspiracy beliefs mediated the effect of the intervention. The intervention, did not directly increase vaccination intentions, however mediation analysis showed that the normative feedback increased perceptions of other parents' vaccination intentions, which in turn increased personal vaccination intentions. No significant effects remained after a six-week follow-up. The current research demonstrates the potential utility of Social Norms Approach interventions for correcting misperceptions and reducing anti-vaccine conspiracy beliefs among UK parents. Further research could explore utilising a top-up intervention to maintain the efficacy.",2021,"The intervention, did not directly increase vaccination intentions, however mediation analysis showed that the normative feedback increased perceptions of other parents' vaccination intentions, which in turn increased personal vaccination intentions.","['UK parents', '202 UK parents of young children']","['normative feedback condition (n = 89) or an assessment-only control condition', 'Social Norms Approach intervention']","['vaccination intentions', 'personal vaccination intentions', ""normative feedback increased perceptions of other parents' vaccination intentions"", 'personal belief']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",,0.0357983,"The intervention, did not directly increase vaccination intentions, however mediation analysis showed that the normative feedback increased perceptions of other parents' vaccination intentions, which in turn increased personal vaccination intentions.","[{'ForeName': 'Darel', 'Initials': 'D', 'LastName': 'Cookson', 'Affiliation': 'Department of Psychology, School of Social Sciences, Nottingham Trent University, Nottingham, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jolley', 'Affiliation': 'Department of Psychology, Northumbria University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Dempsey', 'Affiliation': 'Department of Psychology, Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Povey', 'Affiliation': 'The Staffordshire Centre for Psychological Research, School of Life Sciences and Education, Staffordshire University, Stoke-on-Trent, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0258985']
2986,34763534,Feasibility of self-administered acupressure for allergic rhinitis: a pilot randomized controlled trial and lessons learnt for future studies.,"OBJECTIVES


Allergic rhinitis (AR) is an immunoglobulin (Ig)E-mediated inflammatory condition that is highly prevalent worldwide. The aim of this pilot trial was to evaluate the feasibility and safety of self-administered acupressure for AR.
METHODS


A randomized, single-blind, non-specific controlled clinical trial was conducted at Royal Melbourne Institute of Technology (RMIT) University, Melbourne, Australia. Fifteen AR patients were randomized into two groups: self-administered acupressure at five specific acupressure (SA) points or five non-specific acupressure (NSA) points (1 min/point, twice a day), and treated for 4 weeks with an 8-week follow-up period. The primary outcome was the change in 7-point scale symptom severity. Secondary outcomes included the rhinoconjunctivitis quality of life questionnaire and standardized activities (RQLQs), medication usage, adverse events and participants' opinions of the blinding method. The Statistical Package for the Social Science (SPSS) version 26 was used for data analyses.
RESULTS


Fourteen participants completed the study and no major adverse events were reported. No statistically significant differences between SA and NSA groups were identified in 7-point scale symptom severity scores, RQLQs or medication usage. However, participants in the SA group believed that SA was useful for AR and recommended it for self-care. The credibility of the blinding method was successful. No adverse effects were considered to be related to the intervention.
CONCLUSION


Acupressure is feasible and appears to be safe for self-administration by AR sufferers. Experience from this pilot study has guided minor amendments to the protocol. A large-scale randomized controlled trial is warranted to further investigate the efficacy and safety of self-administered acupressure for the management of AR.",2021,"No statistically significant differences between SA and NSA groups were identified in 7-point scale symptom severity scores, RQLQs or medication usage.","['Fifteen AR patients', 'Allergic rhinitis (AR', 'allergic rhinitis']","['Acupressure', 'Technology (RMIT', 'self-administered acupressure at five specific acupressure (SA) points or five non-specific acupressure (NSA', 'SA', 'self-administered acupressure']","['7-point scale symptom severity scores, RQLQs or medication usage', 'feasibility and safety', 'adverse effects', ""rhinoconjunctivitis quality of life questionnaire and standardized activities (RQLQs), medication usage, adverse events and participants' opinions of the blinding method"", 'change in 7-point scale symptom severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",15.0,0.143455,"No statistically significant differences between SA and NSA groups were identified in 7-point scale symptom severity scores, RQLQs or medication usage.","[{'ForeName': 'Yaqun', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC, Australia.'}, {'ForeName': 'George Binh', 'Initials': 'GB', 'LastName': 'Lenon', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC, Australia.'}, {'ForeName': 'Mingdi', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC, Australia.'}, {'ForeName': 'Angela Wei Hong', 'Initials': 'AWH', 'LastName': 'Yang', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC, Australia.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/09645284211055757']
2987,34763506,Effect of dialectical behavior group therapy on the anxiety and depression of medical students under the normalization of epidemic prevention and control for the COVID-19 epidemic: a randomized study.,"BACKGROUND


During the epidemic, the mental health of college students was generally poor, especially anxiety and depression, which should be treated using counseling and intervention. This study aimed to observe the influence of dialectical behavior therapy on the anxiety and depression of medical students during the normalization of the prevention and control of the COVID-19 epidemic.
METHODS


A total of 26 medical students (experimental group) were treated with dialectical behavior therapy intervention for 4 weeks. Changes in depression, anxiety, and stress levels were assessed by the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder (GAD-7) scale, the Somatic Self-rating Scale (SSS), and the Perceived Stress Scale (PSS-10). This group was compared with 26 medical students (control group) without intervention.
RESULTS


The value-added scores of the PHQ-9 (t=2.543, P=0.014) and GAD-7 scales (t=3.790, P=0.000) in the experimental group were significantly higher than those in the control group, while in the SSS scale, the value-added score of the depressive symptoms subscale (t=2.234, P=0.030) in the experimental group was significantly higher than that of the control group. For the total score of the PSS-10 scale (t=2.435, P=0.018), the value-added score of the experimental group was significantly higher than that of the control group.
CONCLUSIONS


The intervention of dialectical behavior therapy can effectively alleviate the depression and anxiety of medical students during the normalization of epidemic prevention and control.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR2100048784.",2021,"For the total score of the PSS-10 scale (t=2.435, P=0.018), the value-added score of the experimental group was significantly higher than that of the control group.
","['26 medical students (experimental group', 'medical students under the normalization of epidemic prevention and control for the COVID-19 epidemic']","['26 medical students (control group) without intervention', 'dialectical behavior therapy intervention', 'dialectical behavior group therapy', 'dialectical behavior therapy']","['value-added scores of the PHQ-9', 'GAD-7 scales', 'depression, anxiety, and stress levels', 'SSS scale, the value-added score of the depressive symptoms subscale', 'anxiety and depression', 'Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder (GAD-7) scale, the Somatic Self-rating Scale (SSS), and the Perceived Stress Scale (PSS-10', 'total score of the PSS-10 scale']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",26.0,0.0204305,"For the total score of the PSS-10 scale (t=2.435, P=0.018), the value-added score of the experimental group was significantly higher than that of the control group.
","[{'ForeName': 'Lizhen', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of General Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'AIDS Training Center, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Central Operating Room, Shiyan Taihe Hospital, Shiyan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of General Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Mental Health and Psychological Science, Anhui Medical University, Hefei, China.'}]",Annals of palliative medicine,['10.21037/apm-21-2466']
2988,34763504,Clinical efficacy of bevacizumab combined with cisplatin in the treatment of malignant pleural effusion and ascites caused by lung cancer: a randomized trial.,"BACKGROUND


To analyze the clinical effect of bevacizumab combined with cisplatin in the treatment of malignant pleural effusion and ascites.
METHODS


A total of 86 patients with malignant pleural effusion and ascites admitted from June 2018 to September 2020 were selected as the research participants and randomly divided into a control group and observation group, with 43 cases in each group. The control group was given cisplatin intracavitary perfusion scheme, and the observation group was given bevacizumab combined with cisplatin intracavitary perfusion scheme. The Symptom Checklist 90 (SCL-90), Hamilton Depression Scale (HAM-D), and Hamilton Anxiety Scale (HAM-A) were used to evaluate participants' self-perceived negative symptoms, depression, and anxiety. The therapeutic effect and adverse reactions of the 2 groups were compared. The t-test was used for measurement data, and c2 test was used for enumeration data. Statistical significance was considered at P<0.05.
RESULTS


After treatment, the serum levels of hypoxia inducible factor-1 (HIF-1α) and vascular endothelial growth factor (VEGF) in the observation group were significantly decreased and statistically lower than those in the control group (both P<0.05); the malignant pleural and abdominal water volume, average urine volume, and average chest circumference of the observation group were improved, and the difference was statistically significant compared with the control group (all P<0.05). The scores of each factor of SCL-90 in the observation group were decreased, among which the scores of somatization, interpersonal sensitivity, depression, anxiety, hostility, and terror in the observation group were significantly lower than those in the control group (all P<0.05); after treatment, the HAMD and HAMA scores of the observation group decreased, and the scores of HAMD (13.71±5.98) and HAMA (17.62±3.98) of the observation group were significantly lower than the score of (16.52±5.75) and (21.54±4.77) of the control group (both P<0.05).
CONCLUSIONS


In the clinical treatment of malignant pleural effusion and ascites, bevacizumab combined with cisplatin intracavitary perfusion can improve the clinical treatment effect, reduce the depression and anxiety of patients, optimize patient quality of life, and improve the safety of treatment.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR2100048959.",2021,"After treatment, the serum levels of hypoxia inducible factor-1 (HIF-1α) and vascular endothelial growth factor (VEGF) in the observation group were significantly decreased and statistically lower than those in the control group (both P<0.05); the malignant pleural and abdominal water volume, average urine volume, and average chest circumference of the observation group were improved, and the difference was statistically significant compared with the control group (all P<0.05).","['86 patients with malignant pleural effusion and ascites admitted from June 2018 to September 2020', 'malignant pleural effusion and ascites', 'malignant pleural effusion and ascites caused by lung cancer']","['cisplatin intracavitary perfusion scheme', 'bevacizumab combined with cisplatin intracavitary perfusion', 'bevacizumab combined with cisplatin', 'bevacizumab combined with cisplatin intracavitary perfusion scheme']","['serum levels of hypoxia inducible factor-1 (HIF-1α) and vascular endothelial growth factor (VEGF', 'Symptom Checklist 90 (SCL-90), Hamilton Depression Scale (HAM-D), and Hamilton Anxiety Scale (HAM-A', ""participants' self-perceived negative symptoms, depression, and anxiety"", 'scores of HAMD', 'therapeutic effect and adverse reactions', 'malignant pleural and abdominal water volume, average urine volume, and average chest circumference', 'HAMD and HAMA scores', 'scores of each factor of SCL-90', 'scores of somatization, interpersonal sensitivity, depression, anxiety, hostility, and terror']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080032', 'cui_str': 'Neoplastic pleural effusion'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1298613', 'cui_str': 'Intracavitary'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0215848', 'cui_str': 'Hypoxia-Inducible Factor 1'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0424683', 'cui_str': 'Chest circumference'}, {'cui': 'C1291910', 'cui_str': 'Human anti-mouse antibody'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}]",86.0,0.0167886,"After treatment, the serum levels of hypoxia inducible factor-1 (HIF-1α) and vascular endothelial growth factor (VEGF) in the observation group were significantly decreased and statistically lower than those in the control group (both P<0.05); the malignant pleural and abdominal water volume, average urine volume, and average chest circumference of the observation group were improved, and the difference was statistically significant compared with the control group (all P<0.05).","[{'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Palliative Medicine, Benq Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Huiqing', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Palliative Medicine, Benq Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Daoqing', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, Benq Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lanzhu', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Department of Palliative Medicine, Benq Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}]",Annals of palliative medicine,['10.21037/apm-21-2623']
2989,34763495,Diagnostic value of transvaginal three-dimensional ultrasound combined with color Doppler ultrasound for early cesarean scar pregnancy.,"BACKGROUND


Our study sought to obtain data which assess the diagnostic value of transvaginal three-dimensional ultrasound (3D-US) combined with color Doppler ultrasound (US) for early cesarean scar pregnancy (CSP).
METHODS


All participants were randomly divided into a Control group diagnosed using 3D-US and a Combination group diagnosed using 3D-US combined with color Doppler US. The preoperative US results were compared with postoperative pathological results. The diagnostic coincidence rate, sensitivity, and specificity of these two examination methods were compared, and their diagnostic results for different types of CSP were analyzed. Finally, the diagnostic effects of both methods were compared and analyzed, and the imaging of CSP was summarized.
RESULTS


The diagnostic accuracy of transvaginal 3D-US combined with color Doppler US (92.96%) was significantly higher than that of transvaginal 3D-US (71.83%). For different types of CSP, the diagnostic rate of CSP with mixed echogenic mass and partial implantation of gestational sac in the Combination group was markedly higher than that in the Control group.
CONCLUSIONS


Additionally, the sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve (AUC) in the Combination group were higher than those in the Control group. Transvaginal 3D-US combined with color Doppler US can improve the sensitivity, specificity, and accuracy of diagnosis of early CSP, and has important reference value for clinical condition evaluation and treatment options.",2021,The diagnostic accuracy of transvaginal 3D-US combined with color Doppler US (92.96%) was significantly higher than that of transvaginal 3D-US (71.83%).,"['early cesarean scar pregnancy', 'early cesarean scar pregnancy (CSP']","['Transvaginal 3D-US combined with color Doppler US', 'Control group diagnosed using 3D-US and a Combination group diagnosed using 3D-US combined with color Doppler US', 'transvaginal 3D-US combined with color Doppler US', 'transvaginal three-dimensional ultrasound combined with color Doppler ultrasound', 'transvaginal three-dimensional ultrasound (3D-US) combined with color Doppler ultrasound (US']","['diagnostic rate of CSP with mixed echogenic mass and partial implantation of gestational sac', 'sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve (AUC', 'diagnostic coincidence rate, sensitivity, and specificity']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0522507', 'cui_str': 'With color'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0553498', 'cui_str': 'Gestation Sac'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0620439,The diagnostic accuracy of transvaginal 3D-US combined with color Doppler US (92.96%) was significantly higher than that of transvaginal 3D-US (71.83%).,"[{'ForeName': 'Liangyan', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Gynecology, Maternal and Child Healthcare Hospital Hubei, Wuhan, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Gynecology, Maternal and Child Healthcare Hospital Hubei, Wuhan, China; Wuhan University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecology, Maternal and Child Healthcare Hospital Hubei, Wuhan, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Ultrasonic, Maternal and Child Healthcare Hospital Hubei, Wuhan, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Yao', 'Affiliation': 'Department of Gynecology, Maternal and Child Healthcare Hospital Hubei, Wuhan, China.'}, {'ForeName': 'Dejun', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Gynecology, Maternal and Child Healthcare Hospital Hubei, Wuhan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'Department of Gynecology, Maternal and Child Healthcare Hospital Hubei, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Gynecology, Maternal and Child Healthcare Hospital Hubei, Wuhan, China.'}]",Annals of palliative medicine,['10.21037/apm-21-2208']
2990,34763475,"Simplified dressing change after loose combined cutting seton surgery for high anal fistula: a prospective, single center randomized controlled study.","BACKGROUND


High anal fistula (HAF) is a refractory infectious disease. Surgery is the most effective way to treat HAF. Dressing change is an indispensable part of the rehabilitation process after surgery. The purpose of this study is to provide feasibility and evidence of safety for the implementation of a simplified dressing change after loose combined cutting seton (LCCS) surgery and to offer a better method for clinical treatment and postoperative rehabilitation of HAF.
METHODS


In this single-blind randomized controlled trial, 76 patients diagnosed with HAF will be randomly divided into two groups: the simplified dressing change group (n=38) or the traditional debridement and dressing change group (n=38). Compared with traditional debridement and dressing change, simplified dressing change was conducted without mechanical debridement and disinfection. All patients were treated surgically with the LCCS and dressing change. Postoperative follow-up will be carried out on the 3rd, 7th, 14th, 21st, and 180th day after the operation. The primary outcomes will be: complete healing rate of wound and fistula, long-term recurrence rate, poor wound healing rate, and complete wound healing time. The following secondary outcomes will be evaluated: postoperative pain using a visual analogue scale (VAS) score, wound secretions, edema, granulation shape, depth of wound, duration of each dressing change, and incidence of adverse events.
DISCUSSION


Dressing change after HAF surgery is a necessary stage of recovery after anorectal surgery. Effective dressing change can reduce false healing and increase the cure rate. However, traditional dressing change takes a long time, and the patient endures severe pain. We have found that the dressing change process can be simplified in the clinic for patients treated with LCCS. In particular, simplification of the dressing change process may be related to the unobstructed drainage provided by the combination of LCCS and the separation of the dotted line. We will treat HAF using LCCS and compare the simplified dressing change method after the operation with traditional routine debridement and dressing change to demonstrate whether the simplified dressing change can be used in patients with HAF treated with LCCS.
TRIAL REGISTRATION


ChiCTR2100047312.",2021,"The primary outcomes will be: complete healing rate of wound and fistula, long-term recurrence rate, poor wound healing rate, and complete wound healing time.","['patients with HAF treated with LCCS', 'high anal fistula', '76 patients diagnosed with HAF', 'patients treated with LCCS']","['simplified dressing change group (n=38) or the traditional debridement and dressing change group', 'loose combined cutting seton (LCCS) surgery', 'Simplified dressing change after loose combined cutting seton surgery']","['complete healing rate of wound and fistula, long-term recurrence rate, poor wound healing rate, and complete wound healing time', 'cure rate', 'postoperative pain using a visual analogue scale (VAS) score, wound secretions, edema, granulation shape, depth of wound, duration of each dressing change, and incidence of adverse events', 'false healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348083', 'cui_str': 'High anal fistula'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C1827381', 'cui_str': 'Depth of wound'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205237', 'cui_str': 'False'}]",76.0,0.0155632,"The primary outcomes will be: complete healing rate of wound and fistula, long-term recurrence rate, poor wound healing rate, and complete wound healing time.","[{'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Shan', 'Affiliation': 'Graduate School, Beijing University of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Proctology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yicheng', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Proctology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Proctology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Zhi', 'Affiliation': 'Department of Proctology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Graduate School, Beijing University of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yaxuan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Graduate School, Beijing University of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Hongxin', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Graduate School, Beijing University of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Dun', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Graduate School, Beijing University of Traditional Chinese Medicine, Beijing, China.'}]",Annals of palliative medicine,['10.21037/apm-21-2726']
2991,34763441,The comparison of different drip cholangiography: a randomised trial.,"BACKGROUND


This study investigated the advantages and disadvantages of contrast media administration by gravity drip and manual push injection during cholangiography.
METHODS


A total of 100 patients who presented to the Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University, for a cholangiography between June 2019 to June 2020 were enrolled in this study. Patients were randomly divided into 2 treatment groups. One group of patients with manual injection of contrast (the N group, n=50), received the contrast agent via the traditional manual injection method whereby the doctor injects 50 mL of prepared contrast agent into the right side of the patient while continuously observing the effects on the bile duct. The other group of patients with gravity drip administration of contrast media (the O group, n=50), received the contrast agent via gravity drip at a rate of 80 drops per minute, and both clinicians and radiologists monitored the entire cholangiography process from a safe distance. Patients were followed up and angiographic satisfaction was assessed after two weeks.
RESULTS


All 100 patients completed cholangiography without allergic reaction to the contrast medium. In the traditional injection group (N group), nine patients experienced upper abdominal discomfort with nausea, abdominal pain, chills, high fever, and other symptoms, and residual gallstones were observed in 12 patients. In patients in the gravity drip group (O group), four patients felt upper abdominal discomfort accompanied by nausea, abdominal pain, chills, high fever, and other symptoms, with residual gallstones detected in six patients.
CONCLUSIONS


Patients who underwent gravity drip cholangiography had significantly reduced adverse reactions compared to patients who underwent traditional manual infusion cholangiography. Furthermore, gravity drip cholangiography resulted in clearer images and reduced X-ray exposure for medical staff. Thus, increased implementation of gravity drip cholangiography in the clinical setting should be considered.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1800018202.",2021,"In the traditional injection group (N group), nine patients experienced upper abdominal discomfort with nausea, abdominal pain, chills, high fever, and other symptoms, and residual gallstones were observed in 12 patients.","['100 patients completed cholangiography without allergic reaction to the contrast medium', '100 patients who presented to the Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University, for a cholangiography between June 2019 to June 2020 were enrolled in this study']","['gravity drip administration of contrast media', 'contrast media administration by gravity drip and manual push injection', 'drip cholangiography', 'gravity drip cholangiography']","['adverse reactions', 'angiographic satisfaction', 'upper abdominal discomfort accompanied by nausea, abdominal pain, chills, high fever, and other symptoms, with residual gallstones', 'upper abdominal discomfort with nausea, abdominal pain, chills, high fever, and other symptoms, and residual gallstones']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008307', 'cui_str': 'Cholangiogram'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0452837', 'cui_str': 'Dripping'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0008307', 'cui_str': 'Cholangiogram'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1868919', 'cui_str': 'Upper abdominal discomfort'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}]",100.0,0.0342228,"In the traditional injection group (N group), nine patients experienced upper abdominal discomfort with nausea, abdominal pain, chills, high fever, and other symptoms, and residual gallstones were observed in 12 patients.","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Hand, Foot and Ankle Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Shuhong', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Xiangguo', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Taizhou Central Hospital (Affiliated Hospital of Taizhou University), Taizhou, China.'}, {'ForeName': 'Baohua', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': 'Department of Nursing, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Chengsi', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Graduate School, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'Department of Orthopedics, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Haijing', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': ""Department of Cardiology, Ningxia Hui Autonomous Region People's Hospital, Yinchuan, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Hand, Foot and Ankle Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}]",Annals of palliative medicine,['10.21037/apm-21-2661']
2992,34763847,Nothing to Fear but Fear Itself: A Mechanistic Test of Unconscious Exposure.,"BACKGROUND


While effective, exposure therapy can be distressing, which creates problems with treatment acceptance. Can exposure be effectively delivered unconsciously-and thus without causing phobic people to experience distress? No study has tested this hypothesis in a sufficiently rigorous experiment that selected between mechanisms for reducing fear unconsciously.
METHODS


We conducted a psychophysiological experiment of an unconscious exposure intervention to discern its mechanism of therapeutic action. We identified 98 highly spider-phobic participants with a validated fear questionnaire and a Behavioral Avoidance Test in which they gradually approached and exhibited impairment of a live tarantula, which was indicative of a DSM-5 diagnosis of specific phobia. These participants were randomized to viewing unconscious exposure to spiders, visible exposure to spiders, or unconscious exposure to flowers (control). In a novel psychophysiological design, concurrent changes in sympathetic arousal and subjective fear were monitored throughout exposure. Shortly thereafter, phobic participants approached the tarantula again in order to measure exposure-induced changes in real-life avoidance behavior and experienced fear.
RESULTS


Unconscious exposure did not induce concurrent changes in sympathetic arousal or subjective fear, and subsequently reduced fear of the tarantula. Visible exposure to the same phobic stimuli, by contrast, induced significant arousal and fear, but did not affect fear of the tarantula. Levels of arousal during exposure moderated effects on fear of the tarantula: lower arousal during unconscious exposure, but not during conscious exposure, predicted greater fear reduction.
CONCLUSIONS


Unconscious exposure reduces fear by generating new implicit learning of nonaversive, stimulus-response associations that facilitate fear extinction in phobic persons.",2021,"RESULTS


Unconscious exposure did not induce concurrent changes in sympathetic arousal or subjective fear, and subsequently reduced fear of the tarantula.","['98 highly spider-phobic participants with a validated fear questionnaire and a Behavioral Avoidance Test in which they gradually approached and exhibited impairment of a live tarantula, which was indicative of a DSM-5 diagnosis of specific phobia', 'phobic persons']","['viewing unconscious exposure to spiders, visible exposure to spiders, or unconscious exposure to flowers (control']","['Levels of arousal', 'sympathetic arousal and subjective fear', 'real-life avoidance behavior and experienced fear', 'sympathetic arousal or subjective fear']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0236801', 'cui_str': 'Simple phobia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0041654', 'cui_str': 'Unconscious (Psychology)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.0427737,"RESULTS


Unconscious exposure did not induce concurrent changes in sympathetic arousal or subjective fear, and subsequently reduced fear of the tarantula.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, Purchase College, State University of New York, Purchase, New York; Department of Psychiatry, Keck School of Medicine, University of Southern California, Los Angeles, California. Electronic address: paul.siegel@purchase.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychology, New York University, New York, New York.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Warren', 'Affiliation': 'Department of Neuroscience, Columbia University, New York, New York.'}]",Biological psychiatry,['10.1016/j.biopsych.2021.08.022']
2993,34763746,Intervention for promoting intake of fruits and vegetables in Brazilians: a randomised controlled trial.,"OBJECTIVE


To evaluate the effectiveness of a nutritional intervention to promote fruit and vegetable (FV) intake.
DESIGN


A randomised controlled community trial was conducted to evaluate the effectiveness of a 7-month nutritional intervention and to promote FV intake, separately and together. All participants attended physical exercise sessions. The intervention was based on the transtheoretical model and Paulo Freire's pedagogy. The interventions included group educational sessions, motivational cards and informational materials. The primary outcome was a change in FV intake (g/d), and secondary outcomes included stages of change, self-efficacy, decisional balance and knowledge on FV. All data were collected face-to-face; and FV intake was assessed using a validated brief questionnaire.
SETTING


Health promotion services of Brazilian Primary Health Care.
PARTICIPANTS


3414 users of Brazilian Primary Health Care (1931 in the control group and 1483 in the intervention group (IG)).
RESULTS


At baseline, the average daily FV intake was 370·4 g/d (95 % CI 364·2, 376·6). The increase in FV intake (23·4 g/d; 95 % CI 6·7, 40·0) and fruit intake (+17·3 g/d; 95 % CI 5·1, 29·4; P = 0·01) was greater in the IG among participants in the lowest baseline intake. Participants in the IG also showed progression in the stages of change (P < 0·001), increased self-efficacy (P < 0·001) and improved knowledge of FV crops (P < 0·001).
CONCLUSIONS


The nutritional intervention was effective in increasing FV intake and fruits intake among individuals with a lower intake at baseline and in maintaining FV intake among those who reported consuming FV as recommended (400 g/d).",2021,"Participants in the IG also showed progression in the stages of change (P < 0·001), increased self-efficacy (P < 0·001) and improved knowledge of FV crops (P < 0·001).
","['Health promotion services of Brazilian Primary Health Care', 'fruits and vegetables in Brazilians', '3414 users of Brazilian Primary Health Care (1931 in the control group and 1483 in the intervention group (IG']","['educational sessions, motivational cards and informational materials', 'nutritional intervention to promote fruit and vegetable (FV) intake', 'physical exercise sessions', '7-month nutritional intervention']","['self-efficacy', 'average daily FV intake', 'knowledge of FV crops', 'FV intake and fruits intake', 'change in FV intake (g/d), and secondary outcomes included stages of change, self-efficacy, decisional balance and knowledge on FV', 'FV intake']","[{'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0242775', 'cui_str': 'Agricultural Crops'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0810641,"Participants in the IG also showed progression in the stages of change (P < 0·001), increased self-efficacy (P < 0·001) and improved knowledge of FV crops (P < 0·001).
","[{'ForeName': 'Raquel de Deus', 'Initials': 'RD', 'LastName': 'Mendonça', 'Affiliation': 'Department of Nutrition, Universidade Federal de Minas Gerais, Avenue Alfredo Balena, 190, Belo Horizonte, MG30190-100, Brazil.'}, {'ForeName': 'Sueli Aparecida', 'Initials': 'SA', 'LastName': 'Mingoti', 'Affiliation': 'Department of Statistics, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Maria Flávia', 'Initials': 'MF', 'LastName': 'Gazzinelli Bethony', 'Affiliation': 'Department of Applied Nursing, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martinez-Gonzalez', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Maira', 'Initials': 'M', 'LastName': 'Bes-Rastrollo', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Aline Cristine Souza', 'Initials': 'ACS', 'LastName': 'Lopes', 'Affiliation': 'Department of Nutrition, Universidade Federal de Minas Gerais, Avenue Alfredo Balena, 190, Belo Horizonte, MG30190-100, Brazil.'}]",Public health nutrition,['10.1017/S1368980021004341']
2994,34763733,"Effects of the Dietary Approaches to Stop Hypertension (DASH) diet on clinical, quality of life, and mental health outcomes in women with migraine: A randomised controlled trial.","The relationship between the Dietary Approaches to Stop Hypertension (DASH) diet and clinical, quality of life, and mental health outcomes in migraine is unknown. To address this knowledge gap, we conducted a parallel-group, randomised controlled trial to evaluate the effect of the DASH diet on these health outcomes in women with migraine. Of 102 eligible women (20-50 years), 51 randomised to the DASH and 51 to the usual dietary advice (control) groups completed a 12-week intervention. The DASH diet was designed using a 7-day menu cycle to provide 15-20% of total daily energy requirements from proteins, 25-30% from fats, and 55-60% from carbohydrates. Dietary records and serum vitamin C levels were used to assess women's compliance with the DASH diet. The clinical symptoms of migraine (i.e., frequency, duration, severity) and quality of life and mental health (i.e., depression, anxiety, stress) outcomes were assessed in groups pre-and post-intervention. We observed greater decreases in the frequency (-3.00 vs. -1.40, P=0.025) and severity (-1.76 vs. -0.59, P<0.001) of migraine in the DASH vs. control group post-intervention. Similarly, the DASH group exhibited a tendency toward greater decreases in migraine duration (-0.58 vs -0.33 days, P=0.053) and had lower scores of depression (-4.50 vs. -2.73, P=0.019) and stress (-5.84 vs -2.98, P=0.011) vs. controls. However, the quality of life and anxiety outcomes remained comparable in groups post-intervention. Together, evidence supports the benefits of the DASH diet on improving migraine health outcomes in reproductive-aged women. Further research is needed to confirm our findings.",2021,"We observed greater decreases in the frequency (-3.00 vs. -1.40, P=0.025) and severity (-1.76 vs. -0.59, P<0.001) of migraine in the DASH vs. control group post-intervention.","['reproductive-aged women', 'women with migraine', '102 eligible women (20-50 years), 51 randomised to the DASH and 51 to the']","['DASH diet', 'Dietary Approaches to Stop Hypertension (DASH) diet', 'usual dietary advice (control']","['stress', 'quality of life and anxiety outcomes', 'scores of depression', 'clinical, quality of life, and mental health outcomes', 'clinical symptoms of migraine (i.e., frequency, duration, severity) and quality of life and mental health (i.e., depression, anxiety, stress) outcomes', 'serum vitamin C levels', 'migraine health outcomes', 'migraine duration']","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0428585', 'cui_str': 'Serum vitamin C measurement'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",102.0,0.0330111,"We observed greater decreases in the frequency (-3.00 vs. -1.40, P=0.025) and severity (-1.76 vs. -0.59, P<0.001) of migraine in the DASH vs. control group post-intervention.","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Arab', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran E-mail: Arman4369@gmail.com.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran E-mail: fkhorvash@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kazemi', 'Affiliation': 'Human Metabolic Research Unit, Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA E-mail: maryam.kazemi@cornell.edu.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran, E-mail: heidarizahra@hlth.mui.ac.ir.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran E-mail: Askari@mui.ac.ir.'}]",The British journal of nutrition,['10.1017/S000711452100444X']
2995,34763731,Metabolomics profiles of premenopausal women are different based on  O- desmethylangolensin metabotype.,"Urinary O-desmethylangolensin (ODMA) concentrations provide a functional gut microbiome marker of dietary isoflavone daidzein metabolism to ODMA. Individuals who do not have gut microbial environments that produce ODMA have less favorable cardiometabolic and cancer risk profiles. Urinary metabolomics profiles were evaluated in relation to ODMA metabotypes within and between individuals over time. Secondary analysis of data was conducted from the BEAN2 trial, which was a cross-over study of premenopausal women consuming six months on a high- and a low-soy diet, each separated by a 1-month washout period. In all of the 672 samples in the study, 66 of the 84 women had the same ODMA metabotype at seven or all eight time points. Two or four urine samples per woman were selected based on temporal metabotypes in order to compare within and across individuals. Metabolomics assays for primary metabolism and biogenic amines were conducted in 60 urine samples from 20 women. Partial least-squares discriminant analysis was used to compare metabolomics profiles. For the same ODMA metabotype across different time points, no profile differences were detected. For changes in metabotype within individuals and across individuals with different metabotypes, distinct metabolomes emerged. Influential metabolites (variables importance in projection score>2) included several phenolic compounds, carnitine and derivatives, fatty acid and amino acid metabolites, and some medications. Based on the distinct metabolomes of producers vs. non-producers, the ODMA metabotype may be a marker of gut microbiome functionality broadly involved in nutrient and bioactive metabolism, and should be evaluated for relevance to precision nutrition initiatives.",2021,"Influential metabolites (variables importance in projection score>2) included several phenolic compounds, carnitine and derivatives, fatty acid and amino acid metabolites, and some medications.","['primary metabolism and biogenic amines were conducted in 60 urine samples from 20 women', '672 samples in the study, 66 of the 84 women had the same ODMA metabotype at seven or all eight time points', 'premenopausal women']",[],"['Urinary metabolomics profiles', 'several phenolic compounds, carnitine and derivatives, fatty acid and amino acid metabolites']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005496', 'cui_str': 'Biogenic amine'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0164565', 'cui_str': 'O-desmethylangolensin'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}]",[],"[{'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0643256,"Influential metabolites (variables importance in projection score>2) included several phenolic compounds, carnitine and derivatives, fatty acid and amino acid metabolites, and some medications.","[{'ForeName': 'Cara L', 'Initials': 'CL', 'LastName': 'Frankenfeld', 'Affiliation': 'George Mason University, Department of Global and Community Health, Fairfax, Virginia, USA.'}, {'ForeName': 'Gertraud', 'Initials': 'G', 'LastName': 'Maskarinec', 'Affiliation': 'Population Sciences in the Pacific, University of Hawaii Cancer Center, Honolulu, Hawaii, USA.'}, {'ForeName': 'Adrian A', 'Initials': 'AA', 'LastName': 'Franke', 'Affiliation': 'Population Sciences in the Pacific, University of Hawaii Cancer Center, Honolulu, Hawaii, USA.'}]",The British journal of nutrition,['10.1017/S0007114521004463']
2996,34763719,Correction to: Very preterm infants engage in an intervention to train their control of attention: results from the feasibility study of the attention control training (ACT) randomised trial.,,2021,,[],['attention control training (ACT'],[],[],"[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]",[],,0.0482116,,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Perra', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Building, 97 Lisburn Road, Belfast, BT9 7BL, UK. o.perra@qub.ac.uk.""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Wass', 'Affiliation': 'School of Psychology, University of East London, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McNulty', 'Affiliation': 'TinyLife, The Premature Baby Charity for Northern Ireland, Belfast, Northern Ireland, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sweet', 'Affiliation': 'Health and Social Care Belfast Trust, Belfast, Northern Ireland, UK.'}, {'ForeName': 'Kostas A', 'Initials': 'KA', 'LastName': 'Papageorgiou', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Johnston', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Building, 97 Lisburn Road, Belfast, BT9 7BL, UK.""}, {'ForeName': 'Delfina', 'Initials': 'D', 'LastName': 'Bilello', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Building, 97 Lisburn Road, Belfast, BT9 7BL, UK.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Patterson', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Alderdice', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00943-8']
2997,34763714,Improving peer review of systematic reviews by involving librarians and information specialists: protocol for a randomized controlled trial.,"BACKGROUND


Problems continue to exist with the reporting quality and risk of bias in search methods and strategies in systematic reviews and related review types. Peer reviewers who are not familiar with what is required to transparently and fully report a search may not be prepared to review the search components of systematic reviews, nor may they know what is likely to introduce bias into a search. Librarians and information specialists, who have expertise in searching, may offer specialized knowledge that would help improve systematic review search reporting and lessen risk of bias, but they are underutilized as methodological peer reviewers.
METHODS


This study will evaluate the effect of adding librarians and information specialists as methodological peer reviewers on the quality of search reporting and risk of bias in systematic review searches. The study will be a pragmatic randomized controlled trial using 150 systematic review manuscripts submitted to BMJ and BMJ Open as the unit of randomization. Manuscripts that report on completed systematic reviews and related review types and have been sent for peer review are eligible. For each manuscript randomized to the intervention, a librarian/information specialist will be invited as an additional peer reviewer using standard practices for each journal. First revision manuscripts will be assessed in duplicate for reporting quality and risk of bias, using adherence to 4 items from PRISMA-S and assessors' judgements on 4 signaling questions from ROBIS Domain 2, respectively. Identifying information from the manuscripts will be removed prior to assessment.
DISCUSSION


The primary outcomes for this study are quality of reporting as indicated by differences in the proportion of adequately reported searches in first revision manuscripts between intervention and control groups and risk of bias as indicated by differences in the proportions of first revision manuscripts with high, low, and unclear bias. If the intervention demonstrates an effect on search reporting or bias, this may indicate a need for journal editors to work with librarians and information specialists as methodological peer reviewers.
TRIAL REGISTRATION


Open Science Framework. Registered on June 17, 2021, at https://doi.org/10.17605/OSF.IO/W4CK2 .",2021,"Librarians and information specialists, who have expertise in searching, may offer specialized knowledge that would help improve systematic review search reporting and lessen risk of bias, but they are underutilized as methodological peer reviewers.
",['150 systematic review manuscripts submitted to BMJ and BMJ Open as the unit of randomization'],[],[],"[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1955832', 'cui_str': 'Review, Systematic'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",[],[],,0.0933221,"Librarians and information specialists, who have expertise in searching, may offer specialized knowledge that would help improve systematic review search reporting and lessen risk of bias, but they are underutilized as methodological peer reviewers.
","[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Rethlefsen', 'Affiliation': 'Health Sciences Library & Informatics Center, University of New Mexico, MSC 09 5100, 1 University of New Mexico, Albuquerque, NM, 87131-0001, USA. mlrethlefsen@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schroter', 'Affiliation': 'BMJ Publishing Group, London, England.'}, {'ForeName': 'Lex M', 'Initials': 'LM', 'LastName': 'Bouter', 'Affiliation': 'Department of Philosophy, Faculty of Humanities, Vrije Universiteit Amsterdam, De Boelelaan 1105, 1081, HV, Amsterdam, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moher', 'Affiliation': 'Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, Centre for Practice Changing Research Building, 501 Smyth Road, PO BOX 201B, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Ana Patricia', 'Initials': 'AP', 'LastName': 'Ayala', 'Affiliation': 'Gerstein Science Information Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Jamie J', 'Initials': 'JJ', 'LastName': 'Kirkham', 'Affiliation': 'Centre for Biostatistics, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Maurice P', 'Initials': 'MP', 'LastName': 'Zeegers', 'Affiliation': 'Department of Epidemiology, School for Nutrition and Translational Research in Metabolisms, Care and Health Research Institute, Maastricht University Medical Center+, PO Box 616, 6200, MD, Maastricht, The Netherlands.'}]",Trials,['10.1186/s13063-021-05738-z']
2998,34763712,"Parenting interventions for families with refugee backgrounds: a randomized factorial, mixed-methods design study protocol.","BACKGROUND


Raising children in new social and cultural contexts can be challenging for parents. In order to help parents address these challenges, the Norwegian government has instituted a policy of mandatory parent training for families who settle in Norway as refugees. The Incredible Years (IY) and The International Child Development Programme (ICDP) have been widely adopted throughout Norway. They have similar aims: to improve parenting through positive parenting practices and development of attachment behaviors. We will evaluate the use of these programs and a measurement feedback system (MFS) to give regular feedback to interventionists about parents' progress during the course of the parenting intervention.
METHODS


The study is a mixed method, randomized factorial design aimed at evaluating the effect of parenting interventions and the use of feedback to address parental stress, child behavior, resilience, and parents' mental health. Factor 1 is based on random assignment to one of the parenting interventions IY or ICDP. The parenting interventions are delivered over 15 weeks (IY) or 12 weeks (ICDP) in group-based settings. Factor 2 is based on random assignment of the parenting groups to the (a) with MFS or (b) without MFS condition. The MFS is answered weekly via a phone app, MittEcho, and results are sent to group leaders in the MFS condition. Additionally, the study explores the experiences of families settling in a new cultural context and participating with parenting programs via qualitative interviews. Participants will be recruited from a population of parents with children between the age of 6 and 12 years who settled in Norway as refugees within the previous 9 years. The target sample size is N = 360; n (IY) = 180, n (ICDP) = 180 families. This study is a collaboration between first-line, municipal services; their national governing agencies; family representatives; and a national network of research organizations.
DISCUSSION


This study endeavors to provide information about what helps families with refugee background integrate successfully into new cultural contexts with different laws, norms, and expectations. Whether or not these interventions can help to normalize this experience, reduce stress, and provide parents with new tools to improve their parenting and the lives of their children are important questions which we address. These findings can lead to the further establishment of evidence-based practices in Norway.
TRIAL REGISTRATION


ISRCTN35008070 . Registered on February 24, 2020.",2021,"We will evaluate the use of these programs and a measurement feedback system (MFS) to give regular feedback to interventionists about parents' progress during the course of the parenting intervention.
","['families with refugee backgrounds', 'Participants will be recruited from a population of parents with children between the age of 6 and 12\u2009years who settled in Norway as refugees within the previous 9 years', 'N = 360; n (IY) = 180, n (ICDP) = 180 families']","['parenting interventions', 'International Child Development Programme (ICDP', 'Parenting interventions', 'measurement feedback system (MFS']",[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1266099', 'cui_str': 'Spindle epithelial tumor with thymus-like element'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",[],,0.0472066,"We will evaluate the use of these programs and a measurement feedback system (MFS) to give regular feedback to interventionists about parents' progress during the course of the parenting intervention.
","[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Patras', 'Affiliation': 'UiT The Arctic University of Norway, Tromsø, Norway. joshua.patras@r-bup.no.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Saus', 'Affiliation': 'UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Douglas', 'Affiliation': 'UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Bjørknes', 'Affiliation': 'NORCE, Bergen, Norway.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Gammelsæter', 'Affiliation': 'Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Lene-Mari Potulski', 'Initials': 'LP', 'LastName': 'Rasmussen', 'Affiliation': 'UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Halvorsen', 'Affiliation': 'UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Ida Mari', 'Initials': 'IM', 'LastName': 'Haug', 'Affiliation': 'UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Risholm', 'Affiliation': 'Bufetat - Region South, Drammen, Norway.'}, {'ForeName': 'Tuva', 'Initials': 'T', 'LastName': 'Øktedalen', 'Affiliation': 'Bufetat - Region South, Drammen, Norway.'}, {'ForeName': 'Reidar', 'Initials': 'R', 'LastName': 'Jakobsen', 'Affiliation': 'UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Simon Peter', 'Initials': 'SP', 'LastName': 'Neumer', 'Affiliation': 'UiT The Arctic University of Norway, Tromsø, Norway.'}]",Trials,['10.1186/s13063-021-05766-9']
2999,34763711,"IL-1 Signal Inhibition In Alcoholic Hepatitis (ISAIAH): a study protocol for a multicentre, randomised, placebo-controlled trial to explore the potential benefits of canakinumab in the treatment of alcoholic hepatitis.","BACKGROUND


Alcohol consumption causes a spectrum of liver abnormalities and leads to over 3 million deaths per year. Alcoholic hepatitis (AH) is a florid presentation of alcoholic liver disease characterized by liver failure in the context of recent and heavy alcohol consumption. The aim of this study is to explore the potential benefits of the IL-1β antibody, canakinumab, in the treatment of AH.
METHODS


This is a multicentre, double-blind, randomised placebo-controlled trial. Participants will be diagnosed with AH using clinical criteria. Liver biopsy will then confirm that all histological features of AH are present. Up to 58 participants will be recruited into two groups from 15 centres in the UK. Patients will receive an infusion of Canakinumab or matched placebo by random 1:1 allocation. The primary outcome is the difference between groups in the proportion of patients demonstrating histological improvement and will compare histological appearances at baseline with appearances at 28 days to assign a category of ""improved"" or ""not improved"". Patients with evidence of ongoing disease activity will receive a second infusion of canakinumab or placebo. Participants will be followed up for 90 days. Secondary outcomes include mortality and change in MELD score at 90 days.
DISCUSSION


This phase II study will explore the benefits of the IL-1β antibody, canakinumab, in the treatment of AH to provide proof of concept that inhibition of IL-1β signalling may improve histology and survival for patients with AH.
TRIAL REGISTRATION


EudraCT 2017-003724-79 . Prospectively registered on 13 April 2018.",2021,"This phase II study will explore the benefits of the IL-1β antibody, canakinumab, in the treatment of AH to provide proof of concept that inhibition of IL-1β signalling may improve histology and survival for patients with AH.
","['Prospectively registered on 13 April 2018', 'alcoholic hepatitis', '58 participants will be recruited into two groups from 15 centres in the UK', 'Patients with evidence of ongoing disease activity', 'Alcoholic hepatitis (AH', 'patients with AH']","['Canakinumab or matched placebo', 'EudraCT', 'canakinumab or placebo', 'canakinumab', 'placebo']","['proportion of patients demonstrating histological improvement and will compare histological appearances', 'category of ""improved"" or ""not improved', 'mortality and change in MELD score', 'IL-1 Signal Inhibition']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0019187', 'cui_str': 'Alcoholic hepatitis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4048785', 'cui_str': 'Model for end stage liver disease score'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",58.0,0.655371,"This phase II study will explore the benefits of the IL-1β antibody, canakinumab, in the treatment of AH to provide proof of concept that inhibition of IL-1β signalling may improve histology and survival for patients with AH.
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vergis', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK. nvergis@ic.ac.uk.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': ""Institute of Liver Studies, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bogdanowicz', 'Affiliation': 'Imperial Clinical Trials Unit, Department of Surgery and Cancer, Imperial College, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Czyzewska-Khan', 'Affiliation': 'Imperial Clinical Trials Unit, Department of Surgery and Cancer, Imperial College, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Imperial Clinical Trials Unit, Department of Surgery and Cancer, Imperial College, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': 'Imperial Clinical Trials Unit, Department of Surgery and Cancer, Imperial College, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cross', 'Affiliation': 'Imperial Clinical Trials Unit, Department of Surgery and Cancer, Imperial College, London, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Foster', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lord', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Goldin', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Forrest', 'Affiliation': 'Glasgow Royal Infirmary and University of Glasgow, Glasgow, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Thursz', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.'}]",Trials,['10.1186/s13063-021-05719-2']
3000,34763681,Game-based training of selective voluntary motor control in children and youth with upper motor neuron lesions: protocol for a multiple baseline design study.,"BACKGROUND


Impairments of selective control of joint movements can have consequences for many activities of daily life, but there are only a few interventions to improve selective voluntary motor control (SVMC). We have developed a treatment option to specifically enhance SVMC exploiting the advantages of interactive computer play technology. It targets SVMC by training selective activation of a muscle or a selective joint movement while it provides immediate feedback about involuntary muscle activations/movements at an (unwanted) joint. This study aims to investigate the effectiveness of this game-based intervention to enhance SVMC in children and youth with upper motor neuron lesions.
METHODS


We will conduct a randomized, non-concurrent, multiple baseline design study. Patients aged between 6 and 20 years with reduced SVMC due to an upper motor neuron lesion will be included. During the baseline phase of random length, participants will attend their regular intensive rehabilitation program, and in the intervention phase, they will additionally complete 10 therapy sessions (à 40 min) of the game-based SVMC training. The primary outcome will be a short SVMC assessment conducted repeatedly throughout both phases, which quantifies movement accuracy and involuntary movements. Changes in clinical SVMC measures, muscle strength, cortical excitability, motor control of the inhibited/unwanted movement, and functional independence will be assessed as secondary outcomes. We will use a mixed-effect model to determine the change in the course of the primary outcome when the intervention is introduced, and we will compare changes between phases for secondary outcomes with paired tests.
DISCUSSION


This study will provide first evidence whether SVMC can be improved with our game-based training. The single-case design takes into account the individualization required for this intervention, and it can help to address the challenges of intervention trials in our setting.
TRIAL REGISTRATION


German Clinical Trials Register: DRKS00025184 , registered on 28.04.2021.",2021,"Changes in clinical SVMC measures, muscle strength, cortical excitability, motor control of the inhibited/unwanted movement, and functional independence will be assessed as secondary outcomes.","['children and youth with upper motor neuron lesions', 'Patients aged between 6 and 20\u2009years with reduced SVMC due to an upper motor neuron lesion will be included']","['game-based SVMC training', 'game-based intervention', 'Game-based training of selective voluntary motor control', 'SVMC']","['short SVMC assessment conducted repeatedly throughout both phases, which quantifies movement accuracy and involuntary movements', 'clinical SVMC measures, muscle strength, cortical excitability, motor control of the inhibited/unwanted movement, and functional independence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0235834', 'cui_str': 'Upper motor neurone lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0427086', 'cui_str': 'Involuntary movement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0727412,"Changes in clinical SVMC measures, muscle strength, cortical excitability, motor control of the inhibited/unwanted movement, and functional independence will be assessed as secondary outcomes.","[{'ForeName': 'Annina', 'Initials': 'A', 'LastName': 'Fahr', 'Affiliation': ""Swiss Children's Rehab, University Children's Hospital Zurich, Mühlebergstrasse 104, 8910, Affoltern am Albis, Switzerland. annina.fahr@kispi.uzh.ch.""}, {'ForeName': 'Andrina', 'Initials': 'A', 'LastName': 'Kläy', 'Affiliation': ""Swiss Children's Rehab, University Children's Hospital Zurich, Mühlebergstrasse 104, 8910, Affoltern am Albis, Switzerland.""}, {'ForeName': 'Larissa S', 'Initials': 'LS', 'LastName': 'Coka', 'Affiliation': ""Swiss Children's Rehab, University Children's Hospital Zurich, Mühlebergstrasse 104, 8910, Affoltern am Albis, Switzerland.""}, {'ForeName': 'Hubertus J A', 'Initials': 'HJA', 'LastName': 'van Hedel', 'Affiliation': ""Swiss Children's Rehab, University Children's Hospital Zurich, Mühlebergstrasse 104, 8910, Affoltern am Albis, Switzerland.""}]",BMC pediatrics,['10.1186/s12887-021-02983-8']
3001,34767869,Molecular and clinical effects of selective TYK2 inhibition with deucravacitinib in psoriasis.,"BACKGROUND


Psoriasis, a chronic inflammatory disease dependent on the interleukin (IL)-23/T helper cell 17 (Th17) pathway, is initiated through plasmacytoid dendritic cell activation and type I interferon induction in the skin. Deucravacitinib, a selective tyrosine kinase 2 (TYK2) inhibitor, blocks IL-23, IL-12, and type I interferon signaling in cellular assays.
OBJECTIVE


Investigate changes in IL-23/Th17- and type I interferon-pathway biomarkers and gene responses, and measures of selectivity for TYK2 over Janus kinases (JAKs) 1-3, in patients with moderate to severe psoriasis receiving deucravacitinib.
METHODS


Deucravacitinib was evaluated in a randomized, placebo-controlled, dose-ranging trial. Biopsies from non-lesional (Day 1) and lesional skin (Days 1, 15, and 85) were assessed for changes in IL-23/IL-12 and type I interferon pathway biomarkers by quantitative reverse-transcription polymerase chain reaction, RNA sequencing, and immunohistochemistry. Laboratory markers were measured in blood. Percent change from baseline in Psoriasis Area and Severity Index (PASI) score was assessed.
RESULTS


IL-23 pathway biomarkers in lesional skin returned toward non-lesional levels dose-dependently with deucravacitinib. Interferon and IL-12 pathway genes were normalized. Markers of keratinocyte dysregulation, keratin-16, and β-defensin genes approached non-lesional levels with effective dosages. Select laboratory parameters impacted by JAK1-3 inhibition were unaffected by deucravacitinib. Greater improvements in PASI scores, correlated with biomarker changes, were seen with the highest dosages of deucravacitinib versus lower dosages or placebo.
CONCLUSION


Robust clinical efficacy with deucravacitinib treatment was associated with decreases in IL-23/Th17 and interferon pathway biomarkers. The lack of effect seen on biomarkers specific to JAK1-3 inhibition support selectivity of deucravacitinib for TYK2; larger studies are needed to further confirm.",2021,"RESULTS


IL-23 pathway biomarkers in lesional skin returned toward non-lesional levels dose-dependently with deucravacitinib.","['patients with moderate to severe psoriasis receiving deucravacitinib', 'Biopsies from non-lesional (Day 1) and lesional skin ', 'psoriasis']","['Janus kinases (JAKs', 'placebo', 'IL-23/Th17- and type']","['changes in IL-23/IL-12 and type', 'PASI scores', 'Psoriasis Area and Severity Index (PASI) score', 'IL-23/Th17 and interferon pathway biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C0266700', 'cui_str': 'Janiceps'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.151571,"RESULTS


IL-23 pathway biomarkers in lesional skin returned toward non-lesional levels dose-dependently with deucravacitinib.","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Catlett', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA. Electronic address: Ian.Catlett@bms.com.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Subhashis', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'The Rockefeller University, New York, NY, USA.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.11.001']
3002,34767866,"Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease: the ONSET-2 Phase 3, Randomized Trial.","OBJECTIVE


To evaluate the efficacy and safety of OC-01 (varenicline) nasal spray for treatment of patients with dry eye disease.
DESIGN


Randomized, multicenter, double-masked, vehicle-controlled, phase 3 study.
PARTICIPANTS


Adults aged 22 years or more with a diagnosis of dry eye disease, artificial tear use, Ocular Surface Disease Index score of 23 or more, and Schirmer's Test Score (STS) of 10 mm or less. Eligibility was not restricted by Eye Dryness Score (EDS).
METHODS


Patients (N = 758) were randomized in a 1:1:1 ratio to twice-daily treatment with 50-μl intranasal spray in each nostril of OC-01 0.6 mg/ml (n = 260), OC-01 1.2 mg/ml (n = 246), or vehicle (control; n = 252) for 4 weeks (ClinicalTrials.gov, NCT04036292).
MAIN OUTCOME MEASURES


The primary efficacy end point was the percentage of patients achieving a 10-mm improvement or more in STS at week 4. Secondary end points included change from baseline to week 4 in STS and EDS in a controlled adverse environment (CAE) chamber and in the clinic. Treatment-emergent adverse events (TEAEs) were assessed.
RESULTS


A statistically significantly greater percentage of patients achieved the primary end point in both OC-01 treatment groups compared with vehicle (OC-01 0.6 mg/ml, 47.3%; OC-01 1.2 mg/ml, 49.2%; vs. vehicle, 27.8%; P < 0.0001 for both doses). Change from baseline in STS at week 4 was statistically significantly greater for patients receiving OC-01 compared with vehicle (P < 0.0001 for both doses). Eye Dryness Score assessed at week 4 improved with OC-01 treatment compared with vehicle, although the difference between groups was not significant for EDS measured in the CAE chamber, and had (nominal) significance in the clinic. Overall, 86.5% (654/756) of patients reported at least 1 TEAE during the treatment period; most were mild, nonocular (most common events included sneezing, cough, throat irritation, and instillation site irritation), and were reported by fewer patients in the vehicle group than in the OC-01 treatment groups (OC-01 0.6 mg/ml, 97.3%; OC-01 1.2 mg/ml, 99.2%; vehicle, 62.9%).
CONCLUSIONS


OC-01 nasal spray was well tolerated and had a clinically meaningful effect on signs and symptoms of dry eye disease.",2021,"CONCLUSIONS


OC-01 nasal spray was well tolerated and had a clinically meaningful effect on signs and symptoms of dry eye disease.","['Patients (N = 758', ""Adults aged 22 years or more with a diagnosis of dry eye disease, artificial tear use, Ocular Surface Disease Index score of 23 or more, and Schirmer's Test Score (STS) of 10 mm or less"", 'patients with dry eye disease']","['OC-01 (varenicline) nasal spray', 'OC-01 (Varenicline) Nasal Spray', '50-μl intranasal spray in each nostril of OC-01 0.6 mg/ml', 'OC-01 1.2 mg/ml']","['sneezing, cough, throat irritation, and instillation site irritation', 'change from baseline to week 4 in STS and EDS in a controlled adverse environment (CAE) chamber and in the clinic', 'Eye Dryness Score (EDS', 'Eye Dryness Score', 'percentage of patients achieving a 10-mm improvement or more in STS', 'Signs and Symptoms of Dry Eye Disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C4068880', 'cui_str': '1.2'}]","[{'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0700184', 'cui_str': 'Throat irritation'}, {'cui': 'C1096668', 'cui_str': 'Instillation site irritation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0560033', 'cui_str': 'in/s'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]",758.0,0.124335,"CONCLUSIONS


OC-01 nasal spray was well tolerated and had a clinically meaningful effect on signs and symptoms of dry eye disease.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wirta', 'Affiliation': 'Eye Research Foundation, Newport Beach, California. Electronic address: david.wirta@drwirta.com.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vollmer', 'Affiliation': 'Vita Eye Clinic, Shelby, North Carolina.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Paauw', 'Affiliation': 'Piedmont Eye Center, Lynchburg, Virginia.'}, {'ForeName': 'Kuei-Hsun', 'Initials': 'KH', 'LastName': 'Chiu', 'Affiliation': 'Firma Clinical Research, Hunt Valley, Maryland.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Henry', 'Affiliation': 'Firma Clinical Research, Hunt Valley, Maryland.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Striffler', 'Affiliation': 'Oyster Point Pharma, Inc., Princeton, New Jersey.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Nau', 'Affiliation': 'Oyster Point Pharma, Inc., Princeton, New Jersey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2021.11.004']
3003,34767839,Cognitive reappraisal is not always successful during pain anticipation: Stimulus-focused and goal-based reappraisal effects on self-reports and peripheral psychophysiology.,"The present study aims at comparing the effects of two subtypes of cognitive reappraisal (i.e., stimulus-focused vs. goal-based reappraisal) to reduce anticipatory anxiety of pain. Affective ratings, startle reflex, and autonomic measures (electrodermal and heart rate changes) were used as a measure of emotion regulation success. A total of 86 undergraduate students completed an anticipatory task in which they had to regulate their negative emotions or react naturally when faced with the possibility of receiving a painful thermal stimulus. Participants were randomly assigned to two experimental groups to compare the stimulus-focused and goal-based strategies explored here. Our results revealed enhanced self-reported anxiety, electrodermal activity and eyeblink response when participants tried to voluntarily down-regulate their negative emotions, compared to the control instruction. Differences between both cognitive reappraisal groups were not found. These unexpected findings suggest that brief reappraisal instructions may not necessarily be favorable for regulating emotions during anticipation of aversive events. Moreover, these results are further explained in terms of the pain expectation, the painful stimuli modality, and emotion regulation instructions.",2021,"Our results revealed enhanced self-reported anxiety, electrodermal activity and eyeblink response when participants tried to voluntarily down-regulate their negative emotions, compared to the control instruction.",['86 undergraduate students'],"['anticipatory task', 'Cognitive reappraisal', 'cognitive reappraisal (i.e., stimulus-focused vs. goal-based reappraisal']","['anticipatory anxiety of pain', 'enhanced self-reported anxiety, electrodermal activity and eyeblink response', 'emotion regulation success', 'Affective ratings, startle reflex, and autonomic measures (electrodermal and heart rate changes']","[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0038186', 'cui_str': 'Startle Reaction'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}]",86.0,0.0246286,"Our results revealed enhanced self-reported anxiety, electrodermal activity and eyeblink response when participants tried to voluntarily down-regulate their negative emotions, compared to the control instruction.","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jaén', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Escrig', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Matthias J', 'Initials': 'MJ', 'LastName': 'Wieser', 'Affiliation': 'Erasmus University of Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'M Carmen', 'Initials': 'MC', 'LastName': 'Pastor', 'Affiliation': 'Universitat Jaume I, Castellón, Spain. Electronic address: mpastor@uji.es.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2021.10.015']
3004,34767836,"No apparent effects of a viscous, superabsorbent hydrogel on appetite, energy intake, or fecal excretion in overweight adults.","As the obesity epidemic continues, there is a great need for safe and effective weight loss aids. A superabsorbent hydrogel device administered as a capsule demonstrates potential for weight loss, but its mechanism of action remains unclear. The present study's goal was to determine the mechanisms of action of the hydrogel through the investigation of its effects on appetitive sensations, eating behavior, energy intake, and fecal excretion of energy. Overweight and obese adults (n=18) participated in a double-blind, randomized, crossover-design study in which they were provided all meals for a week in a supervised setting (i.e., controlled-feeding) and were required to either consume the hydrogel or a placebo with 16-oz of water 20 minutes before lunch and dinner. No differences in appetite (all, p>0.05), total nitrogen fecal excretion (p=0.74), total fat fecal excretion (p=0.54), or total fecal energy excretion (p=0.76) were determined when comparing the hydrogel to a placebo. Affect towards food (i.e., mood, emotions) was more positive in the hydrogel group compared with the placebo group. A subset of the controlled-feeding group (n=10) then participated in another double-blind, randomized, crossover-design study in which they provided their own food for a week (i.e., free-feeding) and were required to either consume the hydrogel or a placebo with 16-oz of water 20 minutes before lunch and dinner. No differences in appetite (all, p>0.05), energy intake (p=0.95), diet quality (all, p>0.05), or eating behavior (all, p>0.05) were determined when comparing the hydrogel to the placebo. Future studies with greater statistical power should confirm these findings and investigate other potential mechanisms of action of the hydrogel.",2021,"No differences in appetite (all, p>0.05), energy intake (p=0.95), diet quality (all, p>0.05), or eating behavior (all, p>0.05) were determined when comparing the hydrogel to the placebo.","['overweight adults', 'Overweight and obese adults (n=18']","['viscous, superabsorbent hydrogel', 'placebo', 'placebo with 16-oz of water 20 minutes before lunch and dinner']","['appetite', 'total fecal energy excretion', 'appetite (all, p>0.05), energy intake (p=0.95), diet quality (all, p>0.05), or eating behavior', 'total nitrogen fecal excretion', 'appetitive sensations, eating behavior, energy intake, and fecal excretion of energy', 'appetite, energy intake, or fecal excretion', 'total fat fecal excretion']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1550741', 'cui_str': 'Before lunch'}, {'cui': 'C4048877', 'cui_str': 'Supper'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",18.0,0.231039,"No differences in appetite (all, p>0.05), energy intake (p=0.95), diet quality (all, p>0.05), or eating behavior (all, p>0.05) were determined when comparing the hydrogel to the placebo.","[{'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Reister', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN 47907.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Mattes', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN 47907. Electronic address: mattes@purdue.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2021.113643']
3005,34768161,"A randomized, phase II trial of adjuvant immunotherapy with durable TKI-free survival in patients with chronic phase CML.","PURPOSE


Chronic myeloid leukemia (CP-CML) patients can achieve undetectable minimal residual disease (UMRD) and discontinue tyrosine kinase inhibitors (TKIs). Cellular immunity plays an important role in CML disease control. We conducted a randomized, non-blinded phase II trial of adjuvant immunotherapy with TKIs to facilitate TKI discontinuation.
METHODS


TKI-treated patients with CP-CML were randomized to receive the K562/GM-CSF vaccine (vaccine) OR Interferon-α + Sargramostim (IFN). If UMRD was achieved, then all treatment was stopped. Patients who did not achieve UMRD within one year, had a molecular relapse, or discontinued therapy for toxicity could crossover.
RESULTS


Thirty-four patients were randomized to IFN (n = 18) or vaccine (n = 16), and 21 patients crossed over (IFN⟶vaccine: n = 9, vaccine⟶IFN, n = 12). TKIs at enrollment included imatinib (n = 31), nilotinib (n = 2), and dasatinib (n = 1). No patients discontinued vaccine due to side effects, while 33 % of IFN-treated patients discontinued treatment. More patients randomized to IFN (47.4 %, 95 % CI: 16.7-66.7 %) versus vaccine (25.0 %, 95 % CI: 0.5-43.5 %) achieved UMRD within one year. Seven patients randomized to IFN discontinued treatment with 28.6 % (95 % CI: 8.9-92.2 %) sustaining treatment-free remission (TFR) at 1 year, while three patients randomized to vaccine discontinued treatment with none sustaining TFR. Including crossover, there was a cumulative discontinuation success rate of 36.4 % (95 % CI: 16.6 %-79.5 %) after adjuvant IFN. Patients who sustained TFR received a median of 29 months of imatinib prior to discontinuation.
CONCLUSION


Adjuvant IFN led to durable TFRs with limited prior TKI exposure with comparable success to prior discontinuation trials, but many patients stopped IFN early.",2021,"More patients randomized to IFN (47.4 %, 95 % CI: 16.7-66.7 %) versus vaccine (25.0 %, 95 % CI: 0.5-43.5 %) achieved UMRD within one year.","['TKI-treated patients with CP-CML', 'patients with chronic phase CML', 'Patients who did not achieve UMRD within one year, had a molecular relapse, or discontinued therapy for toxicity could crossover', 'Thirty-four patients', 'Chronic myeloid leukemia (CP-CML) patients']","['IFN', 'vaccine', '21 patients crossed over (IFN⟶vaccine: n = 9, vaccine⟶IFN', 'vaccine discontinued treatment with none sustaining TFR', 'K562/GM-CSF vaccine (vaccine) OR Interferon-α + Sargramostim (IFN', 'adjuvant immunotherapy']","['cumulative discontinuation success rate', 'side effects', 'UMRD']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0023474', 'cui_str': 'Chronic phase chronic myeloid leukemia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0216231', 'cui_str': 'sargramostim'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}]",34.0,0.176746,"More patients randomized to IFN (47.4 %, 95 % CI: 16.7-66.7 %) versus vaccine (25.0 %, 95 % CI: 0.5-43.5 %) achieved UMRD within one year.","[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Webster', 'Affiliation': 'Hematologic Malignancies and Bone Marrow Transplantation Program, Department of Oncology, Johns Hopkins University School of MedIcine, Baltimore, MD, United States. Electronic address: jwebst17@jhmi.edu.'}, {'ForeName': 'Tara M', 'Initials': 'TM', 'LastName': 'Robinson', 'Affiliation': 'BioMarin, San Rafael, CA, United States.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Blackford', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Warlick', 'Affiliation': 'Division of Hematology, Oncology, and Transplantation, Department of Medicine, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ferguson', 'Affiliation': 'Hematologic Malignancies and Bone Marrow Transplantation Program, Department of Oncology, Johns Hopkins University School of MedIcine, Baltimore, MD, United States.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Borrello', 'Affiliation': 'Hematologic Malignancies and Bone Marrow Transplantation Program, Department of Oncology, Johns Hopkins University School of MedIcine, Baltimore, MD, United States.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Zahurak', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'Hematologic Malignancies and Bone Marrow Transplantation Program, Department of Oncology, Johns Hopkins University School of MedIcine, Baltimore, MD, United States.'}, {'ForeName': 'B Douglas', 'Initials': 'BD', 'LastName': 'Smith', 'Affiliation': 'Hematologic Malignancies and Bone Marrow Transplantation Program, Department of Oncology, Johns Hopkins University School of MedIcine, Baltimore, MD, United States.'}]",Leukemia research,['10.1016/j.leukres.2021.106737']
3006,34768124,Correlates of days of medication for opioid use disorder exposure among people living with HIV in Northern Vietnam.,"BACKGROUND


In Vietnam, access to medications for opioid use disorder (MOUD) for people living with HIV has rapidly expanded, but MOUD use over time remains low. We sought to assess factors associated with days of MOUD treatment exposure.
METHODS


From 2015 to 2019, patients with OUD in six Northern Vietnamese HIV clinics were randomized to receive HIV clinic-based buprenorphine (BUP/NX) or referral for methadone maintenance therapy (MMT) and followed for 12 months. All MOUD doses were directly observed and abstracted from dosing logs. The primary outcome was days of MOUD treatment exposure (buprenorphine or methadone) received over 12 months. Negative binomial regression modelled associations with days of MOUD exposure.
RESULTS


Of 281 participants, 264 (94%) were eligible for analysis. Participants were primarily male (97%), unmarried (61%), employed (54%), and previously arrested (83%). Participants had a mean 187 (SD 150) days of MOUD exposure with 134 (51%) having at least 180 days, and 35 (13.2%) having at least 360 days of MOUD exposure. Age (IRR 1.26, 95% CI 1.02-1.55), income (IRR 0.96, 95% CI 0.93-1.001), and methadone (IRR 1.88, 95% CI 1.51-2.42) were associated with MOUD exposure in multivariate models. Multivariate models predicted 127 (95% CL 109-147) days of MOUD exposure for HIV clinic based-buprenorphine vs 243 (95% CL 205-288) for MMT.
CONCLUSION


MOUD treatment exposure was suboptimal among patients with HIV and OUD in Northern Vietnam and was influenced by several factors. Interventions to support populations at risk of lower MOUD exposure as well programs administering MOUD should be considered in countries seeking to expand access to MOUD.",2021,"Multivariate models predicted 127 (95% CL 109-147) days of MOUD exposure for HIV clinic based-buprenorphine vs 243 (95% CL 205-288) for MMT.
","['Participants had a mean 187 (SD 150) days of MOUD exposure with 134 (51%) having at least 180 days, and 35 (13.2%) having at least 360 days of MOUD exposure', 'people living with HIV in Northern Vietnam', 'patients with HIV and OUD in Northern Vietnam', 'From 2015 to 2019', 'Of 281 participants, 264 (94%) were eligible for analysis', 'Participants were primarily male (97%), unmarried (61%), employed (54%), and previously arrested (83', 'patients with OUD in six Northern Vietnamese HIV clinics']","['HIV clinic-based buprenorphine (BUP/NX) or referral for methadone maintenance therapy (MMT', 'buprenorphine']",['days of MOUD treatment exposure (buprenorphine or methadone'],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}]",,0.127051,"Multivariate models predicted 127 (95% CL 109-147) days of MOUD exposure for HIV clinic based-buprenorphine vs 243 (95% CL 205-288) for MMT.
","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Button', 'Affiliation': 'MD/MCR Program, School of Medicine, Oregon Health & Science University, Portland, OR, USA. Electronic address: buttond@ohsu.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Cook', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine and Geriatrics, Section of Addiction Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'MD/PhD Program, School of Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Tong Thi', 'Initials': 'TT', 'LastName': 'Khuyen', 'Affiliation': 'Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Kunkel', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine and Geriatrics, Section of Addiction Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Bart', 'Affiliation': 'Hennepin Healthcare, Minneapolis, MN, USA.'}, {'ForeName': 'Dinh Thanh', 'Initials': 'DT', 'LastName': 'Thuy', 'Affiliation': 'Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Diep Bich', 'Initials': 'DB', 'LastName': 'Nguyen', 'Affiliation': 'Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Blazes', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Le Minh', 'Initials': 'LM', 'LastName': 'Giang', 'Affiliation': 'Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'P Todd', 'Initials': 'PT', 'LastName': 'Korthuis', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine and Geriatrics, Section of Addiction Medicine, Oregon Health & Science University, Portland, OR, USA.'}]",The International journal on drug policy,['10.1016/j.drugpo.2021.103503']
3007,34768093,Impairment of speech auditory feedback error detection and motor correction in post-stroke aphasia.,"INTRODUCTION


The present study investigated how damage to left-hemisphere brain networks affects the ability for speech auditory feedback error detection and motor correction in post-stroke aphasia.
METHODS


34 individuals with left-hemisphere stroke and 25 neurologically intact age-matched control participants performed two randomized experimental tasks in which their online speech auditory feedback was altered using externally induced pitch-shift stimuli: 1) vocalization of a steady speech vowel sound /a/, and 2) listening to the playback of the same self-produced vowel vocalizations. Randomized control condition trials were interleaved in between vocalization and listening tasks where no pitch-shift stimuli were delivered. Following each trial, participants pressed a button to indicate whether they detected a pitch-shift error in their speech auditory feedback during vocalization and listening tasks.
RESULTS


Our data analysis revealed that speech auditory feedback error detection accuracy rate was significantly lower in the stroke compared with control participants, irrespective of the experimental task (i.e. vocalization vs. listening) and trial condition (i.e. pitch-shifted vs. no-pitch-shift). We found that this effect was associated with the reduced magnitude of speech compensation in the early phase of responses at 150-200 ms following the onset of pitch-shift stimuli in stroke participants. In addition, motor speech compensation deficit in the stroke group was correlated with lower scores on speech repetition tasks as an index of language impairment resulting from aphasia.
CONCLUSIONS


These findings provide evidence that left-hemisphere stroke is associated with impaired speech auditory feedback error processing, and such deficits account for specific aspects of language impairment in aphasia.",2021,"Our data analysis revealed that speech auditory feedback error detection accuracy rate was significantly lower in the stroke compared with control participants, irrespective of the experimental task (i.e. vocalization vs. listening) and trial condition (i.e. pitch-shifted vs. no-pitch-shift).",['34 individuals with left-hemisphere stroke and 25 neurologically intact age-matched control participants'],"['randomized experimental tasks in which their online speech auditory feedback was altered using externally induced pitch-shift stimuli: 1) vocalization of a steady speech vowel sound /a/, and 2) listening to the playback of the same self-produced vowel vocalizations', 'pitch-shift error in their speech auditory feedback during vocalization and listening tasks']","['speech repetition tasks', 'motor speech compensation deficit', 'speech auditory feedback error detection accuracy rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0042932', 'cui_str': 'Singing, Animal'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0347984', 'cui_str': 'During'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",34.0,0.106847,"Our data analysis revealed that speech auditory feedback error detection accuracy rate was significantly lower in the stroke compared with control participants, irrespective of the experimental task (i.e. vocalization vs. listening) and trial condition (i.e. pitch-shifted vs. no-pitch-shift).","[{'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Sangtian', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, United States of America.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, United States of America.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Fridriksson', 'Affiliation': 'Aphasia Lab, Department of Communication Sciences and Disorders, Arnold School of Public Health, University of South Carolina, 915 Greene St., Columbia, SC 29208, United States of America; Center for the Study of Aphasia Recovery (C-STAR), Department of Communication Sciences and Disorders, Arnold School of Public Health, University of South Carolina, 915 Greene St., Columbia, SC 29208, United States of America.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Behroozmand', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, United States of America. Electronic address: r-behroozmand@sc.edu.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2021.106163']
3008,34768016,E-learning versus face-to-face training: comparison of two learning methods for Lyme borreliosis.,"OBJECTIVES


To compare two learning methods for Lyme disease (e-learning versus face-to-face training) to assess knowledge and know-how.
METHODS


The study population was volunteer general medicine residents and family physicians (FP). Face-to-face training on Lyme disease was offered to each group. E-learning training was then offered to those who had not attended the face-to-face training. Theoretical knowledge was assessed by an identical pre- and post-test questionnaire and know-how by a script concordance test.
RESULTS


Seventy learners (47 FPs and 23 general medicine residents) were included in the face-to-face training group and 61 (33 FPs and 28 general medicine residents) in the e-learning group. The pre- and post-test scores were significantly improved in the FP group (difference of 29.3 ±1.9 [p<0.0001] out of 100) as well as in the general medicine resident group (difference of 38.2 ±2.7 [p<0.0001] out of 100). E-learning was more effective than face-to-face training, particularly among general medicine residents (progression of mean difference of 44.3 ±3.4/100 vs 30.9 ±4.0/100; p=0.0138) and to a lesser extent among FPs (progression of 25.3 ±2.3/100 vs 31.9 ±2.7/100; p=0.0757). Forty-six script concordance tests were completed by FPs and 20 by general medicine residents. Script concordance test results did not seem significant between the subgroups.
CONCLUSIONS


E-learning seems to be a good alternative to face-to-face training for Lyme disease. It seems to be more effective than face-to-face training for the acquisition of theoretical knowledge. The script concordance test evaluation of know-how did not show any difference between the two learning methods.",2021,"E-learning was more effective than face-to-face training, particularly among general medicine residents (progression of mean difference of 44.3 ±3.4/100 vs 30.9 ±4.0/100; p=0.0138) and to a lesser extent among FPs (progression of 25.3 ±2.3/100 vs 31.9 ±2.7/100; p=0.0757).","['Seventy learners (47 FPs and 23 general medicine residents) were included in the face-to-face training group and 61 (33 FPs and 28 general medicine residents) in the e-learning group', 'volunteer general medicine residents and family physicians (FP', 'Lyme borreliosis', 'Forty-six script concordance tests were completed by FPs and 20 by general medicine residents']","['E-learning versus face-to-face training', 'E-learning training']",['pre- and post-test scores'],"[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0024198', 'cui_str': 'Lyme disease'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2676780', 'cui_str': 'Progeroid Syndrome, Congenital, Petty Type'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0154854,"E-learning was more effective than face-to-face training, particularly among general medicine residents (progression of mean difference of 44.3 ±3.4/100 vs 30.9 ±4.0/100; p=0.0138) and to a lesser extent among FPs (progression of 25.3 ±2.3/100 vs 31.9 ±2.7/100; p=0.0757).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gaudin', 'Affiliation': 'Infectious and Tropical Diseases Department, Clermont-Ferrand University Hospital Center, Reference Center for Osteoarticular Infections, Regional Reference Center for Tick-Based Vector Diseases, Genome and Environment Microorganisms Laboratory, Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tanguy', 'Affiliation': 'Research Unit ACCePPT self-medication, multi-professional support for patients, Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Plagne', 'Affiliation': 'Infectious and Tropical Diseases Department, Clermont-Ferrand University Hospital Center, Reference Center for Osteoarticular Infections, Regional Reference Center for Tick-Based Vector Diseases, Genome and Environment Microorganisms Laboratory, Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saussac', 'Affiliation': 'Infectious and Tropical Diseases Department, Clermont-Ferrand University Hospital Center, Reference Center for Osteoarticular Infections, Regional Reference Center for Tick-Based Vector Diseases, Genome and Environment Microorganisms Laboratory, Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hansmann', 'Affiliation': 'Service des Maladies Infectieuses, Hôpitaux Universitaires de Strasbourg, Unistra, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jaulhac', 'Affiliation': 'Service des Maladies Infectieuses, Hôpitaux Universitaires de Strasbourg, Unistra, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': ""Medical Microbiologist and Infectious Diseases Specialist, Centre Universitaire de Santé de l'Estrie, Hôpital de Granby, Québec, Canada.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ouchchane', 'Affiliation': 'Biostatistics Unit, Department of Public Health, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Lesens', 'Affiliation': 'Infectious and Tropical Diseases Department, Clermont-Ferrand University Hospital Center, Reference Center for Osteoarticular Infections, Regional Reference Center for Tick-Based Vector Diseases, Genome and Environment Microorganisms Laboratory, Clermont Auvergne University, Clermont-Ferrand, France. Electronic address: olesens@chu-clermontferrand.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Infectious diseases now,['10.1016/j.idnow.2021.11.001']
3009,34767999,"Efficacy of House Dust Mite Sublingual Immunotherapy in Patients with Atopic Dermatitis: A Randomized, Double-blind, Placebo-controlled Trial.","BACKGROUND


Sensitization to house dust mites (HDM) is frequent in patients with atopic dermatitis (AD).
OBJECTIVE


To investigate the efficacy of sublingual immunotherapy (SLIT) with Dermatophagoides pteronyssinus(Dpt) extract in patients with AD sensitized to HDM.
METHODS


In this randomized, double-blind, placebo-controlled trial, we enrolled 91 patients aged ≥3 years, with SCORing Atopic Dermatitis (SCORAD) ≥15 and positive skin test and/or IgE to Dpt. Patients were stratified according to age (<12 and ≥12 years) to receive HDM SLIT or placebo for 18 months. Primary outcome was a >15-point decrease in SCORAD. Secondary outcomes were decreases in SCORAD and objective SCORAD (O-SCORAD), Eczema Area and Severity Index (EASI), visual analog scale (VAS) for symptoms, pruritus scale; Investigator's Global Assessment (IGA) 0/1; and decrease ≥4 points in Dermatology Life Quality Index (DLQI). Background therapy was maintained.
RESULTS


A total of 66 patients completed the study (35 HDM SLIT, 31 placebo). After 18 months, 74.2% and 58% patients in HDM SLIT and placebo groups, respectively, showed >15-point decrease in SCORAD (relative risk[RR]1.28, 95% confidence interval[CI] 0.89-1.83). Significant SCORAD decreases from baseline of 55.6% and 34.5% in HDM SLIT and placebo groups (mean difference 20.4;95%CI 3.89-37.3); significant O-SCORAD decreases of 56.8% and 34.9% in HDM SLIT and placebo groups (mean difference 21.3;95%CI 0.66-41.81); and more patients with IGA 0/1 in HDM SLIT group as compared to placebo group (14/35 vs 5/31;RR 2.63, 95%CI 1.09-6.39), were observed at 18 months.
CONCLUSION


Our results suggest that HDM SLIT may be effective in HDM sensitized patients as an add-on treatment for AD.",2021,"Significant SCORAD decreases from baseline of 55.6% and 34.5% in HDM SLIT and placebo groups (mean difference 20.4;95%CI 3.89-37.3); significant O-SCORAD decreases of 56.8% and 34.9% in HDM SLIT and placebo groups (mean difference 21.3;95%CI 0.66-41.81); and more patients with IGA 0/1 in HDM SLIT group as compared to placebo group (14/35 vs 5/31;RR 2.63, 95%CI 1.09-6.39), were observed at 18 months.
","['Patients with Atopic Dermatitis', 'patients with AD sensitized to HDM', 'patients with atopic dermatitis (AD', 'Patients were stratified according to age (<12 and ≥12 years) to receive', '66 patients completed the study (35 HDM SLIT, 31 placebo', '91 patients aged ≥3 years, with SCORing Atopic Dermatitis (SCORAD) ≥15 and positive skin test and/or IgE to Dpt']","['Placebo', 'HDM SLIT or placebo', 'sublingual immunotherapy (SLIT) with Dermatophagoides pteronyssinus(Dpt) extract', 'HDM SLIT', 'House Dust Mite Sublingual Immunotherapy', 'placebo']","[""SCORAD and objective SCORAD (O-SCORAD), Eczema Area and Severity Index (EASI), visual analog scale (VAS) for symptoms, pruritus scale; Investigator's Global Assessment (IGA) 0/1; and decrease ≥4 points in Dermatology Life Quality Index (DLQI"", 'SCORAD', '15-point decrease in SCORAD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0524581', 'cui_str': 'House dust'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0542213', 'cui_str': 'Skin test positive'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0323674', 'cui_str': 'Dermatophagoides'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0524581', 'cui_str': 'House dust'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0323674', 'cui_str': 'Dermatophagoides'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}]",91.0,0.634705,"Significant SCORAD decreases from baseline of 55.6% and 34.5% in HDM SLIT and placebo groups (mean difference 20.4;95%CI 3.89-37.3); significant O-SCORAD decreases of 56.8% and 34.9% in HDM SLIT and placebo groups (mean difference 21.3;95%CI 0.66-41.81); and more patients with IGA 0/1 in HDM SLIT group as compared to placebo group (14/35 vs 5/31;RR 2.63, 95%CI 1.09-6.39), were observed at 18 months.
","[{'ForeName': 'Sarah Sella', 'Initials': 'SS', 'LastName': 'Langer', 'Affiliation': 'Departments of Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil; Departments of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Renata Nahas', 'Initials': 'RN', 'LastName': 'Cardili', 'Affiliation': 'Departments of Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Janaina Michelle Lima', 'Initials': 'JML', 'LastName': 'Melo', 'Affiliation': 'Departments of Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Mariana Paes Leme', 'Initials': 'MPL', 'LastName': 'Ferriani', 'Affiliation': 'Departments of Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Adriana Santos', 'Initials': 'AS', 'LastName': 'Moreno', 'Affiliation': 'Departments of Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Marina Mendonça', 'Initials': 'MM', 'LastName': 'Dias', 'Affiliation': 'Departments of Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bueno-Filho', 'Affiliation': 'Departments of Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Renata Helena Candido', 'Initials': 'RHC', 'LastName': 'Pocente', 'Affiliation': 'Departments of Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Pérsio', 'Initials': 'P', 'LastName': 'Roxo-Junior', 'Affiliation': 'Departments of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Jorgete', 'Initials': 'J', 'LastName': 'Silva', 'Affiliation': 'Departments of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Fabiana Cardoso Pereira', 'Initials': 'FCP', 'LastName': 'Valera', 'Affiliation': 'Departments of Otorhinolaryngology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil; Clinical Research Unit, Ribeirão Preto Medical School Hospital, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Eduardo Barbosa', 'Initials': 'EB', 'LastName': 'Coelho', 'Affiliation': 'Departments of Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Clóvis Eduardo Santos', 'Initials': 'CES', 'LastName': 'Galvão', 'Affiliation': 'Division of Clinical Immunology and Allergy, University of São Paulo Medical School Hospital, São Paulo, SP, Brazil.'}, {'ForeName': 'Fábio', 'Initials': 'F', 'LastName': 'Carmona', 'Affiliation': 'Departments of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Davi Casale', 'Initials': 'DC', 'LastName': 'Aragon', 'Affiliation': 'Departments of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Luisa Karla', 'Initials': 'LK', 'LastName': 'Arruda', 'Affiliation': 'Departments of Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil. Electronic address: karla@fmrp.usp.br.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2021.10.060']
3010,34767967,Anatomical and fMRI-network comparison of multiple DLPFC targeting strategies for repetitive transcranial magnetic stimulation treatment of depression.,"BACKGROUND


The efficacy of repetitive transcranial magnetic stimulation (rTMS) for depression may vary depending on the subregion stimulated within the dorsolateral prefrontal cortex (DLPFC). Clinical TMS typically uses scalp-based landmarks for DLPFC targeting, rather than individualized MRI guidance.
OBJECTIVE


In rTMS patients, determine the brain systems targeted by multiple DLPFC stimulation rules by computing several surrogate measures: underlying brain targets labeled with connectivity-based atlases, subgenual cingulate anticorrelation strength, and functionally connected networks.
METHODS


Forty-nine patients in a randomized controlled trial of rTMS therapy for treatment resistant major depression underwent structural and functional MRI. DLPFC rules were applied virtually using MR-image guidance. Underlying cortical regions were labeled, and connectivity with the subgenual cingulate and whole-brain computed.
RESULTS


Scalp-targeting rules applied post hoc to these MRIs that adjusted for head size, including Beam F3, were comparably precise, successful in directly targeting classical DLPFC and frontal networks, and anticorrelated with the subgenual cingulate. In contrast, all rules involving fixed distances introduced variability in regions and networks targeted. The 5 cm rule targeted a transitional DLPFC region with a different connectivity profile from the adjusted rules. Seed-based connectivity analyses identified multiple regions, such as posterior cingulate and inferior parietal lobe, that warrant further study in order to understand their potential contribution to clinical response.
CONCLUSION


EEG-based rules consistently targeted DLPFC brain regions with resting-state fMRI features known to be associated with depression response. These results provide a bridge from lab to clinic by enabling clinicians to relate scalp-targeting rules to functionally connected brain systems.",2021,"Seed-based connectivity analyses identified multiple regions, such as posterior cingulate and inferior parietal lobe, that warrant further study in order to understand their potential contribution to clinical response.
",['Forty-nine patients'],"['rTMS therapy', 'repetitive transcranial magnetic stimulation (rTMS']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],49.0,0.0432681,"Seed-based connectivity analyses identified multiple regions, such as posterior cingulate and inferior parietal lobe, that warrant further study in order to understand their potential contribution to clinical response.
","[{'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Cardenas', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Bhat', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA; Palo Alto Veterans Institute for Research, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Horwege', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Ehrlich', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA; University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lavacot', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'Mental Health Service, San Francisco Veterans Affairs Health Care System, University of California, San Francisco, San Francisco, CA, USA; Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Glover', 'Affiliation': 'Department of Radiology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Roach', 'Affiliation': 'Mental Health Service, San Francisco Veterans Affairs Health Care System, University of California, San Francisco, San Francisco, CA, USA; Northern California Institute for Research and Education, San Francisco Veterans Affairs Medical Center, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Forman', 'Affiliation': 'Department of Veterans Affairs, Veterans Affairs Medical Center, Pittsburgh, PA, USA; Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, USA.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'VISN4 Mental Illness Research, Education, and Clinical Center at the Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, 19104, USA; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Yesavage', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Yurgelun-Todd', 'Affiliation': 'Rocky Mountain Network Mental Illness Research Education and Clinical Centers (VISN 19), VA Salt Lake City Health Care System, Salt Lake City, UT, USA; Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Rosen', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA. Electronic address: rosena@stanford.edu.'}]",Brain stimulation,['10.1016/j.brs.2021.11.008']
3011,34767940,"A comparison of GABA-ergic (propofol) and non-GABA-ergic (dexmedetomidine) sedation on visual and motor cortical oscillations, using magnetoencephalography.","Studying changes in cortical oscillations can help elucidate the mechanistic link between receptor physiology and the clinical effects of anaesthetic drugs. Propofol, a GABA-ergic drug produces divergent effects on visual cortical activity: increasing induced gamma-band responses (GBR) while decreasing evoked responses. Dexmedetomidine, an α2- adrenergic agonist, differs from GABA-ergic sedatives both mechanistically and clinically as it allows easy arousability from deep sedation with less cognitive side-effects. Here we use magnetoencephalography (MEG) to characterize and compare the effects of GABA-ergic (propofol) and non-GABA-ergic (dexmedetomidine) sedation, on visual and motor cortical oscillations. Sixteen male participants received target-controlled infusions of propofol and dexmedetomidine, producing mild-sedation, in a placebo-controlled, cross-over study. MEG data was collected during a combined visuomotor task. The key findings were that propofol significantly enhanced visual stimulus induced GBR (44% increase in amplitude) while dexmedetomidine decreased it (40%). Propofol also decreased the amplitudes of the Mv100 (visual M100) (27%) and Mv150 (52%) visual evoked fields (VEF), whilst dexmedetomidine had no effect on these. During the motor task, neither drug had any significant effect on movement related gamma synchrony (MRGS), movement related beta de-synchronisation (MRBD) or Mm100 (movement-related M100) movement-related evoked fields (MEF), although dexmedetomidine slowed the Mm300. Dexmedetomidine increased (92%) post-movement beta synchronisation/rebound (PMBR) power while propofol reduced it (70%, statistically non- significant). Overall, dexmedetomidine and propofol, at equi-sedative doses, produce contrasting effects on visual induced GBR, VEF, PMBR and MEF. These findings provide a mechanistic link between the known receptor physiology of these sedative drugs with their known clinical effects and may be used to explore mechanisms of other anaesthetic drugs on human consciousness.",2021,"Propofol also decreased the amplitudes of the Mv100 (visual M100) (27%) and Mv150 (52%) visual evoked fields (VEF), whilst dexmedetomidine had no effect on these.",['Sixteen male participants'],"['propofol', 'Dexmedetomidine', 'magnetoencephalography (MEG', 'dexmedetomidine', 'propofol and dexmedetomidine', 'Propofol', 'GABA-ergic (propofol) and non-GABA-ergic (dexmedetomidine) sedation', 'dexmedetomidine and propofol']","['post-movement beta synchronisation/rebound (PMBR) power', 'visual induced GBR, VEF, PMBR and MEF', 'visual stimulus induced GBR', 'amplitudes of the Mv100 (visual M100', 'movement related gamma synchrony (MRGS), movement related beta de-synchronisation (MRBD) or Mm100 (movement-related M100) movement-related evoked fields (MEF']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}]",16.0,0.0222884,"Propofol also decreased the amplitudes of the Mv100 (visual M100) (27%) and Mv150 (52%) visual evoked fields (VEF), whilst dexmedetomidine had no effect on these.","[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Saxena', 'Affiliation': 'Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Cardiff CF24 4HQ, United Kingdom; Department of Anaesthetics, Intensive Care and Pain Medicine, Cwm Taf Morgannwg University Health Board, Llantrisant CF72 8XR, United Kingdom. Electronic address: SaxenaN2@cardiff.ac.uk.'}, {'ForeName': 'Suresh D', 'Initials': 'SD', 'LastName': 'Muthukumaraswamy', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, Auckland University, Auckland 1123, New Zealand; School of Psychology, Faculty of Medical and Health Sciences, Auckland University, Auckland 1123, New Zealand.'}, {'ForeName': 'Lewys', 'Initials': 'L', 'LastName': 'Richmond', 'Affiliation': 'Department of Anaesthetics, Morriston Hospital, Swansea, SA6 6NL, United Kingdom.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Babic', 'Affiliation': 'Department of Anaesthetics, Royal Gwent Hospital, Newport, NP20 2UB, United Kingdom.'}, {'ForeName': 'Krish D', 'Initials': 'KD', 'LastName': 'Singh', 'Affiliation': 'Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Cardiff CF24 4HQ, United Kingdom.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Hall', 'Affiliation': 'Department of Anaesthetics, Intensive Care and Pain Medicine, School of Medicine, Cardiff University, Cardiff CF14 4XW, United Kingdom.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Wise', 'Affiliation': 'Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Cardiff CF24 4HQ, United Kingdom; Institute for Advanced Biomedical Technologies, Department of Neuroscience, Imaging and Clinical Sciences, ""G. D\'Annunzio University"" of Chieti-Pescara, 66100, Chieti, Italy.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Shaw', 'Affiliation': 'Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Cardiff CF24 4HQ, United Kingdom; Department of Psychology, University of Exeter, UK.'}]",NeuroImage,['10.1016/j.neuroimage.2021.118659']
3012,34768411,A Randomised-Controlled Clinical Study Examining the Effect of High-Intensity Laser Therapy (HILT) on the Management of Painful Calcaneal Spur with Plantar Fasciitis.,"Calcaneal spur and plantar fasciitis are the most common causes of plantar heel pain. There are many effective physical modalities for treating this musculoskeletal disorder. So far, the are no clear recommendations confirming the clinical utility of high-intensity laser therapy (HILT) in the management of painful calcaneal spur with plantar fasciitis. This study aimed to evaluate the effectiveness of HILT in pain management in patients with calcaneal spur and plantar fasciitis. A group of 65 patients was assessed for eligibility based on the CONSORT guidelines. This study was prospectively registered in the Australian New Zealand Clinical Trial Registry platform (registration number ACTRN12618000744257, 3 May 2018). The main eligibility criteria were: cancer, pregnancy, electronic and metal implants, acute infections, impaired blood coagulation, cardiac arrhythmias, taking analgesic or anti-inflammatory medications, non-experience of heel pain, or presence of other painful foot conditions. Finally, 60 patients were randomly assigned into two groups: study group ( n  = 30, mean age 59.9 ± 10.1), treated with HILT (7 W, 149.9 J/cm 2 , 1064 nm, 4496 J, 12 min), and placebo-controlled group ( n  = 30, mean age 60.4 ± 11.9), treated with sham HILT therapy. Both groups received ultrasound treatments (0.8 W/cm 2 , 1 MHz frequency, 100% load factor, 5 min). Treatment procedures were performed once a day, five times per week for three weeks (total of 15 treatment sessions). Study outcomes focused on pain intensity and were assessed before (M1) and after (M2) the treatment as well as after 4 (M3) and 12 (M4) weeks using the Visual Analogue Scale (VAS) and the Laitinen Pain Scale (LPS). According to VAS, a statistically significant decrease in the study group was observed between M1 and M2 by 3.5 pts, M1 and M3 by 3.7 pts, and M1 and M4 by 3.2 pts ( p  < 0.001). On the other hand, the control group showed a statistically significant decrease ( p  < 0.001) between M1 and M2 by 3.0 pts, M1 and M3 by 3.4 pts, and M1 and M4 by 3.2 pts. According to LPS, a statistically significant decrease in the study group was observed between M1 and M2 by 3.9 pts, M1 and M3 by 4.2 pts, and M1 and M4 by 4.0 pts ( p  < 0.001). On the other hand, the control group showed a statistically significant decrease between M1 and M2 by 3.2 pts ( p  = 0.002), M1 and M3 by 4.0 pts ( p  < 0.001), and M1 and M4 by 3.9 pts ( p  < 0.001). However, there were no statistically significant differences between the groups in VAS and LPS ( p  > 0.05). In conclusion, the HILT does not appear to be more effective in pain management of patients with calcaneal spurs and plantar fasciitis than the conservative standard physiotherapeutic procedures.",2021,"In conclusion, the HILT does not appear to be more effective in pain management of patients with calcaneal spurs and plantar fasciitis than the conservative standard physiotherapeutic procedures.","['Painful Calcaneal Spur with Plantar Fasciitis', 'The main eligibility criteria were: cancer, pregnancy, electronic and metal implants, acute infections, impaired blood coagulation, cardiac arrhythmias, taking analgesic or anti-inflammatory medications, non-experience of heel pain, or presence of other painful foot conditions', 'patients with calcaneal spur and plantar fasciitis', '60 patients', 'A group of 65 patients was assessed for eligibility based on the CONSORT guidelines']","['High-Intensity Laser Therapy (HILT', 'HILT', 'sham HILT therapy', 'intensity laser therapy (HILT', 'placebo-controlled group']","['Visual Analogue Scale (VAS) and the Laitinen Pain Scale (LPS', 'M1 and M2', 'VAS and LPS', 'pain intensity']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0158322', 'cui_str': 'Calcaneal spur'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0275518', 'cui_str': 'Acute infectious disease'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231780', 'cui_str': 'Heel pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0857248', 'cui_str': 'Painful feet'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",60.0,0.0188587,"In conclusion, the HILT does not appear to be more effective in pain management of patients with calcaneal spurs and plantar fasciitis than the conservative standard physiotherapeutic procedures.","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Tkocz', 'Affiliation': 'Institute of Health Sciences, University of Opole, 45-060 Opole, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Matusz', 'Affiliation': 'Institute of Health Sciences, University of Opole, 45-060 Opole, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Kosowski', 'Affiliation': 'Institute of Health Sciences, University of Opole, 45-060 Opole, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Walewicz', 'Affiliation': 'Institute of Health Sciences, University of Opole, 45-060 Opole, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Argier', 'Affiliation': 'Institute of Health Sciences, University of Opole, 45-060 Opole, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Kuszewski', 'Affiliation': 'Institute of Physiotherapy and Health Sciences, Academy of Physical Education, 40-065 Katowice, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Hagner-Derengowska', 'Affiliation': 'Faculty of Earth Sciences and Spatial Management, Nicolaus Copernicus University, 87-100 Torun, Poland.'}, {'ForeName': 'Kuba', 'Initials': 'K', 'LastName': 'Ptaszkowski', 'Affiliation': 'Department of Physiotherapy, Wroclaw Medical University, 50-355 Wroclaw, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dymarek', 'Affiliation': 'Department of Physiotherapy, Wroclaw Medical University, 50-355 Wroclaw, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Taradaj', 'Affiliation': 'Institute of Physiotherapy and Health Sciences, Academy of Physical Education, 40-065 Katowice, Poland.'}]",Journal of clinical medicine,['10.3390/jcm10214891']
3013,34768404,Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis.,"No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode.
METHODS


(1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The effect of albumin (1.5 g/kg at baseline and 1 g/kg on day 3) on 90-day survival rates after a HE episode grade II or higher was evaluated. (2) A meta-analysis of individual patient's data for survival including two clinical trials (BETA and ALFAE) was performed.
RESULTS


In total, 82 patients were included. Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%,  p  = 0.3). A competing risk analysis was performed, observing a 90-day cumulative incidence of death of 9% in the albumin group vs. 20% in the placebo ( p  = 0.1). The meta-analysis showed a benefit in the albumin group, with a lower rate of clinical events (death or liver transplant) than patients in the placebo (HR, 0.44; 95% CI, 0.21-0.82), when analyzed by a competing risk analysis (90-days mortality rate of 11% in the albumin group vs. 30% in the placebo,  p  = 0.02).
CONCLUSIONS


Repeated doses of albumin might be beneficial for patient's survival as an add-on therapy after an HE episode, but an adequately powered trial is needed.",2021,"Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%,  p  = 0.3).","['12 hospitals', '82 patients were included', 'Hepatic Encephalopathy Episode']","['albumin', 'placebo', 'Albumin']","['survival', '90-day survival rates', '90-days mortality rate', '90-day transplant-free survival', 'rate of clinical events (death or liver transplant', '90-day cumulative incidence of death']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",82.0,0.862465,"Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%,  p  = 0.3).","[{'ForeName': 'Meritxell', 'Initials': 'M', 'LastName': 'Ventura-Cots', 'Affiliation': ""Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.""}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Simón-Talero', 'Affiliation': ""Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Poca', 'Affiliation': 'Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Ariza', 'Affiliation': 'Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Masnou', 'Affiliation': 'Gastroenterology Department, Hospital Universitary Germans Tries i Pujol, 08916 Badalona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Sanchez', 'Affiliation': 'Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Elba', 'Initials': 'E', 'LastName': 'Llop', 'Affiliation': 'Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Cañete', 'Affiliation': 'Liver Section, Gastroenterology Department, Hospital del Mar, Hospital del Mar Medical Research Institute (IMIM), Universitat Autònoma de Barcelona, 08003 Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Martín-Llahí', 'Affiliation': 'Gastrointestinal Department, Hospital Moisès Broggi, 08970 Sant Joan Despí, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Amador', 'Affiliation': ""Hepatology Unit, Gastroenterology Department, Hospital de Bellvitge, ICS, Research Group of Hepato-biliary and Pancreatic Diseases (IDIBELL), Barcelona University, 08907 L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez', 'Affiliation': 'Deparment of Gastroenterology, Hospital Universitario Ramon y Cajal, 28034 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Clemente-Sanchez', 'Affiliation': 'Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Puente', 'Affiliation': 'Digestive Disease Department, University Hospital Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla (IDIVAL), 39008 Santander, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Torrens', 'Affiliation': ""Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.""}, {'ForeName': 'Edilmar', 'Initials': 'E', 'LastName': 'Alvarado-Tapias', 'Affiliation': 'Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Napoleone', 'Affiliation': 'Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Miquel-Planas', 'Affiliation': 'Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Ardèvol', 'Affiliation': 'Gastroenterology Department, Hospital Universitary Germans Tries i Pujol, 08916 Badalona, Spain.'}, {'ForeName': 'Meritxell', 'Initials': 'M', 'LastName': 'Casas Rodrigo', 'Affiliation': 'Department of Gastroenterology, Corporació Sanitària Parc Taulí, 08208 Sabadell, Spain.'}, {'ForeName': 'Jose Luís', 'Initials': 'JL', 'LastName': 'Calleja', 'Affiliation': 'Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Solé', 'Affiliation': 'Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Soriano', 'Affiliation': 'Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Genescà', 'Affiliation': ""Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.""}]",Journal of clinical medicine,['10.3390/jcm10214885']
3014,34764637,"Efficacy of Pre-Treatment with Remimazolam on Prevention of Propofol-Induced Injection Pain in Patients Undergoing Abortion or Curettage: A Prospective, Double-Blinded, Randomized and Placebo-Controlled Clinical Trial.","Background


Propofol-induced injection pain (PIP) is a well-known problem in general anesthesia. We hypothesized that pre-treatment with remimazolam prevents PIP in patients undergoing abortion or curettage.
Materials and Methods


In this prospective, single-center, double-blinded, randomized, placebo-controlled clinical trial, adult patients aged 18 to 60 undergoing abortion or curettage were randomly assigned to three groups. Group Lido received system lidocaine (a bolus of 0.5 mg kg -1 , iv). Group Remi received remimazolam (a bolus of 0.1 mg kg -1 , iv). Group NS received identical volumes of 0.9% normal saline. Sixty seconds after the injection of lidocaine, remimazolam or saline, patients were injected with propofol at a rate of 12 mL/min until the loss of consciousness. The primary outcome was the incidence of PIP at the time of induction using 4-point scale. Secondary outcomes included propofol-induced injection pain, vital signs, the characteristics of anesthesia and surgery, and adverse events.
Results


The incidence of patients with PIP was higher in group NS than that in group Lido and group Remi (75.7, 44.3, and 42.9%, respectively,  p  < 0.001). The percentages of patients with moderate PIP were higher in group NS than that in group Lido and group Remi (20.0, 2.9, and 1.4%, respectively,  p  < 0.001). Moreover, the consumption of propofol and the incidence of adverse event (hypoxemia and chin lifting) in group Remi were lower than that in group NS and Lido, and less patients got physical movement and cough in group Remi. The recovery time in group NS was longer than that in group Lido and Remi.
Conclusion


Our findings indicate that pre-treatment with remimazolam reduced the incidence and intensity of PIP in abortion or curettage patients, equivalent to that of lidocaine without severe adverse effects.
Trial Registration


Chinese Clinical Trial Registry (identifier: ChiCTR2100041805).",2021,"Moreover, the consumption of propofol and the incidence of adverse event (hypoxemia and chin lifting) in group Remi were lower than that in group NS and Lido, and less patients got physical movement and cough in group Remi.","['Patients Undergoing Abortion or Curettage', 'patients undergoing abortion or curettage', 'adult patients aged 18 to 60 undergoing abortion or curettage']","['Placebo', 'Remimazolam', 'propofol', 'identical volumes of 0.9% normal saline', 'system lidocaine', 'Propofol-Induced Injection Pain', 'lidocaine, remimazolam or saline', 'Propofol-induced injection pain (PIP', 'remimazolam', 'lidocaine', 'placebo']","['recovery time', 'propofol-induced injection pain, vital signs, the characteristics of anesthesia and surgery, and adverse events', 'adverse event (hypoxemia and chin lifting', 'percentages of patients with moderate PIP', 'incidence of patients with PIP', 'incidence of PIP at the time of induction using 4-point scale', 'incidence and intensity of PIP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0008114', 'cui_str': 'Chin structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",60.0,0.384703,"Moreover, the consumption of propofol and the incidence of adverse event (hypoxemia and chin lifting) in group Remi were lower than that in group NS and Lido, and less patients got physical movement and cough in group Remi.","[{'ForeName': 'Xuehai', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People's Republic of China.""}, {'ForeName': 'Ziyin', 'Initials': 'Z', 'LastName': 'Jiao', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People's Republic of China.""}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People's Republic of China.""}, {'ForeName': 'Huiyu', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People's Republic of China.""}, {'ForeName': 'Susu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People's Republic of China.""}, {'ForeName': 'Hongmeng', 'Initials': 'H', 'LastName': 'Lan', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People's Republic of China.""}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People's Republic of China.""}, {'ForeName': 'Yanmeng', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People's Republic of China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Rehabilitation, The People`s Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, People's Republic of China.""}, {'ForeName': 'Chengxin', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S334100']
3015,34764501,Comparison of block characteristics of intrathecal isobaric levobupivacaine versus isobaric ropivacaine for infra-umbilical surgeries in school-age children: A prospective randomised double-blind study.,"Background and Aims


Levobupivacaine and ropivacaine are effective local anaesthetic drugs used in regional anaesthesia with low cardio-neurotoxicity profile than bupivacaine, but comparative studies are limited in children. So, we compared these two drugs intrathecally to study their efficacy and safety in school-age children.
Methods


This study was carried out in 60 American Society of Anesthesiologists class I, II and III patients aged 6-12 years, of either sex undergoing infra-umbilical surgeries. After institutional ethical committee approval and written informed consent, the patients were randomly divided into two groups. Group A received isobaric levobupivacaine (0.5%, 0.3-0.4 mg/kg), whereas group B received isobaric ropivacaine (0.5%, 0.5 mg/kg) intrathecally. Fentanyl (0.2 μg/kg) was used as an adjuvant in both the groups. Onset, peak and duration of sensory and motor blockade, duration of post-operative analgesia, time for micturition, perioperative haemodynamic parameters and complications were compared.
Results


Onset and peak of sensory and motor block were earlier in group A. Significantly longer duration of sensory and motor block was achieved in group A (251 ± 41 min, 201 ± 40 min) compared to group B (211 ± 21 min, 102 ± 16 min) ( P  < 0.001). The time to first rescue analgesic was also significantly prolonged in group A (270 ± 39 min) compared to group B (233 ± 18 min) ( P  < 0.001). Time to micturition was much early in group B (157 ± 27 min) compared to group A (225 ± 31 min) ( P  < 0.001).
Conclusion


Intrathecal isobaric levobupivacaine and ropivacaine with fentanyl produces effective surgical anaesthesia and postoperative analgesia without any adverse effects. Early regression of sensorimotor blockade makes ropivacaine better in comparison to levobupivacaine for short infra-umbilical surgeries in children.",2021,The time to first rescue analgesic was also significantly prolonged in group A (270 ± 39 min) compared to group B (233 ± 18 min) ( P  < 0.001).,"['III patients aged 6-12 years, of either sex undergoing infra-umbilical surgeries', '60 American Society of Anesthesiologists class', 'children', 'school-age children']","['levobupivacaine', 'ropivacaine', 'Fentanyl', 'isobaric ropivacaine', 'isobaric levobupivacaine', 'fentanyl', 'bupivacaine', 'Levobupivacaine', 'Intrathecal isobaric levobupivacaine', 'intrathecal isobaric levobupivacaine']","['effective surgical anaesthesia and postoperative analgesia', 'Results\n\n\nOnset and peak of sensory and motor block', 'Onset, peak and duration of sensory and motor blockade, duration of post-operative analgesia, time for micturition, perioperative haemodynamic parameters and complications', 'efficacy and safety', 'duration of sensory and motor block', 'time to first rescue analgesic']","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",60.0,0.0764935,The time to first rescue analgesic was also significantly prolonged in group A (270 ± 39 min) compared to group B (233 ± 18 min) ( P  < 0.001).,"[{'ForeName': 'Kanta', 'Initials': 'K', 'LastName': 'Bhati', 'Affiliation': 'Department of Anaesthesia, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Kuraning', 'Affiliation': 'Department of Anaesthesia, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Dhawan', 'Affiliation': 'Department of Anaesthesia, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Irum', 'Initials': 'I', 'LastName': 'Jawaid', 'Affiliation': 'Department of Anaesthesia, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Yunus', 'Initials': 'Y', 'LastName': 'Khilji', 'Affiliation': 'Department of Anaesthesia, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_242_21']
3016,34764499,Tracheal intubation with King Vision video laryngoscope in patients with cervical spine instability-Comparison of straight versus curved reinforced endotracheal tubes.,"Background and Aims


King Vision video laryngoscope is commonly used to facilitate intubation in corrective surgery for cervical spine instability patients due to less manipulation. Curved and straight reinforced tracheal tubes are regularly used in this surgery as neck of the patient is likely to be flexed. We aimed to compare intubation characteristics between the curved and straight reinforced tubes through King Vision video laryngoscope in patients to be operated for cervical spine instability with the primary objective being intubation time.
Methods


Sixty patients undergoing cervical spine surgery were enroled in this prospective randomised comparative clinical study. All were intubated after applying manual in-line stabilisation of the neck, using either curved (group C) or straight (group S) reinforced endotracheal tubes through King Vision video laryngoscope. The intubation time, number of attempts, incidence of tube impingement with arytenoids/aryepiglottic folds, optimisation manoeuvres required and complications were observed. Unpaired 't' test and Chi-square test were used to analyse the data using MedCalc software, version 12.5.
Results


Time taken for intubation was shorter with curved compared to straight reinforced tube (16.24 ± 3.09 vs. 29.08 ± 5.48 seconds,  P  < 0.0001) The first attempt success rate was higher using curved than straight reinforced tube (93.3% vs. 70%,  P  = 0.02). Incidences of impingement with arytenoids/ aryepiglottic folds and optimisation manoeuvres required more with the straight reinforced tube.
Conclusion


The intubation was fast and with higher first attempt success rate with curved than with straight reinforced tube through King Vision videolaryngoscope when used in patients with cervical spine instability.",2021,"The first attempt success rate was higher using curved than straight reinforced tube (93.3% vs. 70%,  P  = 0.02).","['patients with cervical spine instability-Comparison of', 'patients with cervical spine instability', 'cervical spine instability patients', 'patients to be operated for cervical spine instability with the primary objective being intubation time', 'Sixty patients undergoing cervical spine surgery']","['straight (group S) reinforced endotracheal tubes through King Vision video laryngoscope', 'curved and straight reinforced tubes through King Vision video laryngoscope', 'straight versus curved reinforced endotracheal tubes', 'straight reinforced tube through King Vision videolaryngoscope', 'Tracheal intubation with King Vision video laryngoscope']","['intubation time, number of attempts, incidence of tube impingement with arytenoids/aryepiglottic folds, optimisation manoeuvres required and complications', 'Results\n\n\nTime taken for intubation', 'success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0410652', 'cui_str': 'Cervical spine instability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0587273', 'cui_str': 'Armored endotracheal tube'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0003943', 'cui_str': 'Arytenoid cartilage structure'}, {'cui': 'C0225560', 'cui_str': 'Aryepiglottic fold structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",60.0,0.0264655,"The first attempt success rate was higher using curved than straight reinforced tube (93.3% vs. 70%,  P  = 0.02).","[{'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Anaesthesiology, Medical College, Vadodara, Gujarat, India.'}, {'ForeName': 'Devyani J', 'Initials': 'DJ', 'LastName': 'Desai', 'Affiliation': 'Department of Anaesthesiology, Medical College, Vadodara, Gujarat, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_86_21']
3017,34764498,Effect of diffusion of anaesthetic gases on fibre-optic view change of laryngeal mask airway and post-operative laryngo-pharyngeal morbidity in children - A randomised controlled trial.,"Background and Aims


The diffusion of nitrous oxide (N 2 O) into the air-filled cuff of the classic laryngeal mask airway (LMA) may lead to an increase in cuff pressure (CP) and displacement of LMA affecting its performance. This study was conducted to evaluate the change in optimal position of LMA by fibre-optic bronchoscope, the changes in cuff pressure and oropharyngeal leak pressure (OLP), and post-operative laryngo-pharyngeal morbidity during N 2 O-oxygen (O 2 ) anaesthesia in children.
Methods


After ethics committee approval and written informed consent, 84 children, aged 2 to 8 years undergoing lower abdominal surgery using LMA were included. Anaesthesia was induced with sevoflurane and maintained with either 33% O 2  in air (Group 1) or with 33% O 2  in 67% N 2 O (Group 2) along with sevoflurane. The position of LMA using fibre-optic bronchoscope, CP and OLP were recorded at 30, 60 and 90 minutes and at the end of surgery. The incidence of post-operative sore throat, hoarseness of voice and dysphagia was assessed for 24 hours.
Results


A mild (Grade 1) change in fibre-optic position of LMA was observed in 6 out of 42 children maintained with N 2 O-O 2  anaesthesia. The cuff pressure was higher than baseline in group 2 at all three time points with the maximum at 90 minutes (93.23 ± 14.86 cm H 2 O vs. 39.78 ± 7.75 cm H 2 O;  P  < 0.05). The OLP was comparable between the groups during the initial 60 minutes and then increased in group 2. The incidence of post-operative sore throat was significantly higher in group 2 ( P  = 0.008).
Conclusion


The diffusion of anaesthetic gases into the air-filled cuff does not change the fibre-optic position of the LMA significantly but increases the cuff pressure and incidence of post-operative laryngo-pharyngeal complications in children.",2021,"The incidence of post-operative sore throat was significantly higher in group 2 ( P  = 0.008).
","['children', '84 children, aged 2 to 8 years undergoing lower abdominal surgery using LMA were included', 'children ']","['sevoflurane', 'N 2 O-oxygen (O 2 ) anaesthesia', 'nitrous oxide (N 2 O) into the air-filled cuff of the classic laryngeal mask airway (LMA']","['cuff pressure and oropharyngeal leak pressure (OLP), and post-operative laryngo-pharyngeal morbidity', 'incidence of post-operative sore throat, hoarseness of voice and dysphagia', 'OLP', 'incidence of post-operative sore throat', 'cuff pressure (CP', 'cuff pressure and incidence of post-operative laryngo-pharyngeal complications', 'fibre-optic position of LMA', 'cuff pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}]","[{'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}]",42.0,0.0935816,"The incidence of post-operative sore throat was significantly higher in group 2 ( P  = 0.008).
","[{'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bharti', 'Affiliation': 'Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Bala', 'Affiliation': 'Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Revathi', 'Initials': 'R', 'LastName': 'Lokala', 'Affiliation': 'Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Neeru', 'Initials': 'N', 'LastName': 'Sahni', 'Affiliation': 'Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Samujh', 'Affiliation': 'Department of Pediatric Surgery, PGIMER, Chandigarh, India.'}]",Indian journal of anaesthesia,['10.4103/ija.ija_432_21']
3018,34764467,Daily briefing: Largest trial shows psilocybin is effective to treat depression.,,2021,,[],"['psilocybin', 'Daily briefing']",[],[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],,0.11285,,"[{'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Graham', 'Affiliation': ''}]",Nature,['10.1038/d41586-021-03413-6']
3019,34764848,Cerebellar Theta Burst Stimulation on Walking Function in Stroke Patients: A Randomized Clinical Trial.,"Objectives:  The objective of this study was to explore the efficacy of cerebellar intermittent theta burst stimulation (iTBS) on the walking function of stroke patients.  Methods:  Stroke patients with walking dysfunction aged 25-80 years who had suffered their first unilateral stroke were included. A total of 36 patients [mean (SD) age, 53 (7.93) years; 10 women (28%)] were enrolled in the study. All participants received the same conventional physical therapy, including transfer, balance, and ambulation training, during admission for 50 min per day during 2 weeks (10 sessions). Every session was preceded by 3 min procedure of cerebellar iTBS applyed over the contralesional cerebellum in the intervention group or by a similar sham iTBS in control group. The groups were formed randomly and the baseline characteristics showed no significant difference. The primary outcome measure was Fugl-Meyer Assessment-Lower Extremity scores. Secondary outcomes included walking performance and corticospinal excitability. Measures were performed before the intervention beginning (T0), after the first (T1) and the second (T2) weeks.  Results:  The Fugl-Meyer Assessment for lower extremity scores slightly improved with time in both groups with no significant difference between the groups and over the time. The walking performance significantly improved with time and between group. Two-way mixed measures ANOVA showed that there was significant interaction between time and group in comfortable walking time ( F   2,68  = 6.5242,  P  = 0.0080, η 2   partial  = 0.276, ε = 0.641), between-group comparisons revealed significant differences at T1 ( P  = 0.0072) and T2 ( P  = 0.0133). The statistical analysis of maximum walking time showed that there was significant interaction between time and groups ( F   2,68  = 5.4354,  P  = 0.0115, η 2   partial  = 0.198, ε = 0.734). Compared with T0, the differences of maximum walking time between the two groups at T1 ( P  = 0.0227) and T2 ( P  = 0.0127) were statistically significant. However, both the Timed up and go test and functional ambulation category scale did not yield significant differences between groups ( P  > 0.05).  Conclusion:  Our results revealed that applying iTBS over the contralesional cerebellum paired with physical therapy could improve walking performance in patients after stroke, implying that cerebellar iTBS intervention may be a noninvasive strategy to promote walking function in these patients. This study was registered at ChiCTR, number ChiCTR1900026450.",2021,Results:  The Fugl-Meyer Assessment for lower extremity scores slightly improved with time in both groups with no significant difference between the groups and over the time.,"['Stroke Patients', '36 patients [mean (SD) age, 53 (7.93) years; 10 women (28%)] were enrolled in the study', 'stroke patients', 'Stroke patients with walking dysfunction aged 25-80 years who had suffered their first unilateral stroke were included']","['Cerebellar Theta Burst Stimulation', 'cerebellar intermittent theta burst stimulation (iTBS', 'conventional physical therapy, including transfer, balance, and ambulation training']","['Walking Function', 'maximum walking time', 'functional ambulation category scale', 'Fugl-Meyer Assessment-Lower Extremity scores', 'comfortable walking time', 'walking performance and corticospinal excitability', 'walking performance', 'Fugl-Meyer Assessment for lower extremity scores']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1276390', 'cui_str': 'Ambulation training'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",36.0,0.0532702,Results:  The Fugl-Meyer Assessment for lower extremity scores slightly improved with time in both groups with no significant difference between the groups and over the time.,"[{'ForeName': 'Yun-Juan', 'Initials': 'YJ', 'LastName': 'Xie', 'Affiliation': 'Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qing-Chuan', 'Initials': 'QC', 'LastName': 'Wei', 'Affiliation': 'Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ling-Yi', 'Initials': 'LY', 'LastName': 'Liao', 'Affiliation': 'Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Bao-Jin', 'Initials': 'BJ', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hui-Xin', 'Initials': 'HX', 'LastName': 'Tan', 'Affiliation': 'Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Han-Hong', 'Initials': 'HH', 'LastName': 'Jiang', 'Affiliation': 'Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qi-Fan', 'Initials': 'QF', 'LastName': 'Guo', 'Affiliation': 'Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}]",Frontiers in neuroscience,['10.3389/fnins.2021.688569']
3020,34764722,Effect of red ginseng on visual function and vision-related quality of life in patients with glaucoma.,"Background


Red ginseng has been found to improve ocular perfusion and dry eye syndrome in glaucomatous eyes; however, its effects on visual function and vision-related quality of life have not been investigated. This study sought to evaluate the effects of red ginseng on visual function and vision-related quality of life in glaucoma patients using contrast sensitivity and a questionnaire.
Methods


Participants were randomly assigned to two groups in this prospective, randomized, double-blind study: in one group, red ginseng was taken first, followed by a placebo, and in the other, placebo was taken first, followed by red ginseng. We measured and compared changes in contrast sensitivity and vision-related quality of life between the two groups. Contrast sensitivity was measured using OPTEC® 6500P, and vision-related quality of life was evaluated using the 25-item National Eye Institute Visual Function Questionnaire. One-way and two-way repeated measure analyses of variance were used for the comparison. Relationships between respective changes in dry eye syndrome and contrast sensitivity were also analyzed.
Results


Daytime contrast sensitivity and ocular pain improved after the administration of red ginseng. Nighttime contrast sensitivity was improved in early or moderate glaucoma. Improved contrast sensitivity was not associated with improvement in dry eye syndrome.
Conclusion


Red ginseng could improve contrast sensitivity and ocular pain in patients with glaucoma. The mechanism underlying improvement in contrast sensitivity appears to be associated with enhanced retinal perfusion or retinal ganglion cell function, but not dry eye syndrome.",2021,"Improved contrast sensitivity was not associated with improvement in dry eye syndrome.
","['patients with glaucoma', 'glaucoma patients using contrast sensitivity and a questionnaire']","['red ginseng was taken first, followed by a placebo, and in the other, placebo', '\n\n\nRed ginseng', 'red ginseng', 'Red ginseng']","['contrast sensitivity and ocular pain', '25-item National Eye Institute Visual Function Questionnaire', 'Daytime contrast sensitivity and ocular pain', 'Contrast sensitivity', 'contrast sensitivity', 'contrast sensitivity and vision-related quality of life', 'visual function and vision-related quality of life', 'Nighttime contrast sensitivity', 'OPTEC® 6500P, and vision-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0134017', 'cui_str': 'Optec'}]",,0.0285623,"Improved contrast sensitivity was not associated with improvement in dry eye syndrome.
","[{'ForeName': 'Kwanghyun', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Heon', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Kong Eye Clinic, Seoul, Republic of Korea.'}, {'ForeName': 'Joo Yeon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Wungrak', 'Initials': 'W', 'LastName': 'Choi', 'Affiliation': 'Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Gong Je', 'Initials': 'GJ', 'LastName': 'Seong', 'Affiliation': 'Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chan Yun', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jun Mo', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Siloam Eye Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyoung Won', 'Initials': 'HW', 'LastName': 'Bae', 'Affiliation': 'Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Journal of ginseng research,['10.1016/j.jgr.2021.03.004']
3021,34764687,Effect of Ultrasound-Guided Thoracolumbar Interfascial Plane Block on the Analgesic Requirements in Patients Undergoing Lumbar Spine Surgery Under General Anesthesia: A Randomized Controlled Trial.,"Background


Thoracolumbar interfascial plane (TLIP) block was recently described as a regional anesthetic technique to achieve analgesia for lumbar spine surgery by blocking the dorsal rami of spinal nerves. The study aims to test the hypothesis that TLIP block can offer pain control and reduce the perioperative analgesic requirement in patients undergoing spinal surgery.
Methods


There were 60 patients scheduled for lumbar spine surgery who were randomly assigned into two equal groups, TLIP and control groups. Patients in the TLIP group received general anesthesia and TLIP block while patients in the control group received general anesthesia alone. The primary outcome was the analgesic consumption in the first postoperative 24 hours, while intraoperative additional analgesic needs, time to the first request of postoperative analgesia, and pain scores were the secondary outcomes.
Results


At 24 hours postoperatively, morphine consumption was lower in the TLIP group (5.13±1.55) versus the control group (14.33±2.58) mg. The intraoperative fentanyl consumption was lower in the TLIP group (15±35.11 mcgs) versus the control group (105±62.08 mcgs). Postoperative first request for analgesia was delayed in the TLIP group (7.30±2.69 h) compared to the control group (0.92±1.23 h). Postoperative Pain scores at rest were 2.53 ± 0.97 and 3.43 ± 0.50 at 24 hours in the TLIP group and the control group, respectively. Postoperative Pain scores at passive flexion of spine were 2.73 ±0.87 and 3.93 ±0.78 at 24 hours in the TLIP group and the control group, respectively. Patients in the TLIP group had lower perioperative hemodynamic responses to surgical stimulation in comparison to the control group.
Conclusion


Combined TLIP block with general anesthesia in patients undergoing spinal surgery reduced both postoperative and intraoperative analgesic needs, reduced intra-operative hemodynamic response to surgery, and achieved good postoperative pain control.",2021,"At 24 hours postoperatively, morphine consumption was lower in the TLIP group (5.13±1.55) versus the control group (14.33±2.58) mg.","['Patients Undergoing Lumbar Spine Surgery Under General Anesthesia', '60 patients scheduled for lumbar spine surgery', 'patients undergoing spinal surgery']","['TLIP', 'Ultrasound-Guided Thoracolumbar Interfascial Plane Block', 'general anesthesia and TLIP block', 'TLIP block', 'TLIP block with general anesthesia', 'general anesthesia alone']","['good postoperative pain control', 'morphine consumption', 'postoperative and intraoperative analgesic needs, reduced intra-operative hemodynamic response', 'perioperative analgesic requirement', 'Analgesic Requirements', 'Postoperative Pain scores', 'intraoperative fentanyl consumption', 'analgesic consumption in the first postoperative 24 hours, while intraoperative additional analgesic needs, time to the first request of postoperative analgesia, and pain scores', 'Postoperative Pain scores at passive flexion of spine', 'Postoperative first request for analgesia', 'perioperative hemodynamic responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0408578', 'cui_str': 'Operation on lumbar spine'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",60.0,0.221413,"At 24 hours postoperatively, morphine consumption was lower in the TLIP group (5.13±1.55) versus the control group (14.33±2.58) mg.","[{'ForeName': 'Ezzat', 'Initials': 'E', 'LastName': 'Eltaher', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Nasr', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Abuelnaga', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Yassmin', 'Initials': 'Y', 'LastName': 'Elgawish', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}]",Journal of pain research,['10.2147/JPR.S329158']
3022,34765004,"The Preventive Value of Acupoint Sensitization for Patients with Stable Angina Pectoris: A Randomized, Double-Blind, Positive-Controlled, Multicentre Trial.","Background


Acupoint sensitization is considered an important factor in the efficacy of acupoint therapy. This study aimed to evaluate the efficacy of acupressure in the prevention of stable angina pectoris using acupoints with different pressure-pain sensitivities.
Methods


A total of 202 patients were enrolled and randomly assigned to a high-sensitivity group (HSG) ( n  = 109) in which patients received acupressure at the five acupoints with the highest sensitivity to pain and a low-sensitivity group (LSG) ( n  = 93) in which patients received acupressure at the five acupoints with the lowest sensitivity to pain. The duration of acupressure treatment was 4 weeks, and the patients were evaluated at baseline, week 4, and week 8. The primary outcome was a change in the frequency of angina attacks from baseline. The secondary outcomes included nitroglycerin consumption, the Canadian Cardiovascular Society classification, and the Seattle Angina Questionnaire score. Adverse events such as bleeding and subcutaneous haemorrhage were recorded in both groups.
Results


The effect of acupressure compared with baseline on the prevention of angina pectoris in HSG was better than that in LSG at week 4 (incidence rate ratio (IRR): 0.691 and 95% confidence interval (CI): [0.569, 0.839]) and week 8 (IRR: 0.692 and 95% CI: [0.569, 0.839]). No significant difference between groups was found in the frequency of nitroglycerin consumption at week 4 (odds ratio (OR) = 0.863 and 95% CI: [0.147, 5.077]) or week 8 (OR = 1.426 and 95% CI: [0.211, 9.661]). Two themes in the questionnaire showed significantly different changes from baseline between the two groups. Scores on the angina frequency (AF) subscale had changed more from the baseline in the HSG at week 8 than in the LSG (mean difference (MD) = 3.807 and 95% CI: [0.673, 6.942]). Scores on the treatment satisfaction (TS) subscale had also changed more in the HSG than in the LSG at week 4 (MD = 3.651 and 95% CI: [0.327, 7.327]) and week 8 (MD = 4.220 and 95% CI: [0.347, 7.346]). One patient in the LSG reported bruising at the acupoint. No unexpected safety problems arose.
Conclusions


This study showed that acupressure at acupoints with high sensitivity to pain may effectively reduce the frequency of stable angina pectoris episodes. This trial is registered with NCT03975140.",2021,"Scores on the treatment satisfaction (TS) subscale had also changed more in the HSG than in the LSG at week 4 (MD = 3.651 and 95% CI: [0.327, 7.327]) and week 8 (MD = 4.220 and 95% CI: [0.347, 7.346]).","['202 patients', 'Patients with Stable Angina Pectoris']","['acupressure at the five acupoints with the highest sensitivity to pain and a low-sensitivity group (LSG', 'Acupoint Sensitization', 'acupressure at the five acupoints with the lowest sensitivity to pain', 'high-sensitivity group (HSG', 'acupressure']","['nitroglycerin consumption, the Canadian Cardiovascular Society classification, and the Seattle Angina Questionnaire score', 'angina frequency (AF) subscale', 'frequency of stable angina pectoris episodes', 'Adverse events such as bleeding and subcutaneous haemorrhage', 'treatment satisfaction (TS) subscale', 'prevention of angina pectoris in HSG', 'frequency of nitroglycerin consumption', 'frequency of angina attacks']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0423727', 'cui_str': 'High pain threshold'}]","[{'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3695257', 'cui_str': 'Frequency of angina'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",202.0,0.59282,"Scores on the treatment satisfaction (TS) subscale had also changed more in the HSG than in the LSG at week 4 (MD = 3.651 and 95% CI: [0.327, 7.327]) and week 8 (MD = 4.220 and 95% CI: [0.347, 7.346]).","[{'ForeName': 'Shourui', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Acupuncture and Massage, The Third Affiliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, China.'}, {'ForeName': 'Qingyang', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Graduate School of Chengdu University of Traditional Chinese Medicine, Chengdu 610036, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Xindu District Hospital of Traditional Chinese Medicine, Chengdu 610500, China.'}, {'ForeName': 'Mingxiu', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Geriatrics, Sichuan Second Hospital of Traditional Chinese Medicine, Chengdu 610031, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Urology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Ning', 'Affiliation': 'Department of Cardiology, No. 363 Hospital, Chengdu 610041, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'International Medical Centre, General Practice Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xihui', 'Initials': 'X', 'LastName': 'Ying', 'Affiliation': 'Department of Cardiology, Xindu District Hospital of Traditional Chinese Medicine, Chengdu 610500, China.'}, {'ForeName': 'Weiye', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Geriatrics, Sichuan Second Hospital of Traditional Chinese Medicine, Chengdu 610031, China.'}, {'ForeName': 'Fuyu', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""Department of Traditional Chinese Medicine, The First People's Hospital of Longquanyi District, Chengdu 610041, China.""}, {'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, No. 363 Hospital, Chengdu 610041, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'International Medical Centre, General Practice Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Wenzhu', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Blood Transfusion, The First People's Hospital of Longquanyi District, Chengdu 610041, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University, Chengdu 610041, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/7228033']
3023,34765003,Clinical Pilot Study of Rectal Suppository Containing Combined Extract of  Cissus quadrangularis  Linn. and  Acmella paniculata  (Wall ex. DC.) R. K. Jansen in Acute Hemorrhoids.,"Background


Cissus quadrangularis  Linn. (CQ) is a medicinal plant with good evidence for the treatment of hemorrhoids, listed in the Thai National List of Herbal Products in the oral dosage form.  Acmella paniculata  (Wall ex. DC.) R. K. Jansen. (AP) is a medicinal plant with a local anesthetic effect.
Objective


To investigate the potential of rectal suppositories containing CQ and AP extracts to alleviate symptoms of hemorrhoids compared with the commercialized rectal suppository containing hydrocortisone and cinchocaine.
Materials and Methods


Hemorrhoid outpatients ( n  = 105) with different severity grades (I, II, or III) from eight hospitals in northern Thailand were included in this study. Hemorrhoid severity was graded by proctoscopy associated with either anal pain or bleeding related to hemorrhoids or both. The patients were randomly allocated to two groups: CQ-AP group ( n  = 52) or the commercialized rectal suppository group ( n  = 53). One suppository was rectally administered twice daily in the morning and at bedtime for seven days. Evaluations were performed by physicians on days 1, 4, and 8 of the study. The primary endpoints were bleeding and prolapse size, while the secondary endpoint was anal pain.
Results


Baseline demographics, lifestyle, constipation, number of prolapses, grade of hemorrhoid severity, and duration of experiencing hemorrhoids were comparable in both groups of patients. The effects of CQ-AP and the commercialized rectal suppository on bleeding, prolapse size, and anal pain were comparable. The patients in both groups were satisfied with both products at comparable levels and stated a preference for further use in the case of hemorrhoids recurrence. In terms of safety, the patients in the commercialized rectal suppository group experienced a higher incidence of adverse events, including anal pain and bleeding.
Conclusion


Rectal suppositories containing a combined extract of CQ and AP show potential in alleviating hemorrhoidal symptoms with a good safety profile.",2021,"In terms of safety, the patients in the commercialized rectal suppository group experienced a higher incidence of adverse events, including anal pain and bleeding.
","['Hemorrhoid outpatients ( n \u2009=\u2009105) with different severity grades (I, II, or III) from eight hospitals in northern Thailand were included in this study', 'Acute Hemorrhoids']","['Rectal Suppository Containing Combined Extract', 'CQ-AP', 'CQ-AP and the commercialized rectal suppository', 'rectal suppositories containing CQ and AP extracts', 'commercialized rectal suppository', 'DC', 'hydrocortisone and cinchocaine']","['Hemorrhoid severity', 'hemorrhoidal symptoms', 'anal pain or bleeding', 'anal pain', 'adverse events', 'bleeding, prolapse size, and anal pain', 'anal pain and bleeding', 'Baseline demographics, lifestyle, constipation, number of prolapses, grade of hemorrhoid severity, and duration of experiencing hemorrhoids', 'bleeding and prolapse size']","[{'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0991547', 'cui_str': 'Rectal suppository'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0012050', 'cui_str': 'Dibucaine'}]","[{'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0238637', 'cui_str': 'Anal pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",105.0,0.083121,"In terms of safety, the patients in the commercialized rectal suppository group experienced a higher incidence of adverse events, including anal pain and bleeding.
","[{'ForeName': 'Kanokporn', 'Initials': 'K', 'LastName': 'Niwatananun', 'Affiliation': 'Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Wirat', 'Initials': 'W', 'LastName': 'Niwatananun', 'Affiliation': 'Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Sirivipa', 'Initials': 'S', 'LastName': 'Piyamongkol', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Darunee', 'Initials': 'D', 'LastName': 'Hongwiset', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Chidchanok', 'Initials': 'C', 'LastName': 'Ruengorn', 'Affiliation': 'Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Kiatkriangkrai', 'Initials': 'K', 'LastName': 'Koyratkoson', 'Affiliation': 'Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Panee', 'Initials': 'P', 'LastName': 'Sirisa-Ard', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Chansakaow', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Songwut', 'Initials': 'S', 'LastName': 'Yotsawimonwat', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Chalermpong', 'Initials': 'C', 'LastName': 'Saenjum', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Ampai', 'Initials': 'A', 'LastName': 'Phrutivorapongkul', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Suporn', 'Initials': 'S', 'LastName': 'Charumanee', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/5605323']
3024,34764916,The COVID-19 Pandemic Changes the Nudging Effect of Social Information on Individuals' Blood Donation Intention.,"The positive effect of social information on nudging prosocial behavior is context dependent. Understanding how sensitive intervention outcomes are to changes in the choice context is essential for policy design, especially in times of great uncertainty, such as the current COVID-19 pandemic. The present paper explores the effectiveness of social information in changing voluntary blood donation intention in two contexts: before and after the peak of the COVID-19 pandemic in China. In addition to the dimension of context, information content and its source are also important. Using a survey administered to 1,116 participants, we conducted an intertemporal randomized-controlled experiment to systematically analyze how information can effectively nudge the intention to donate blood. Compared with content featuring blood donors' commendation information, blood users' demand information is found to have a stronger nudging effect. An official information source has a greater influence on participants' donation intention than an unofficial source. Furthermore, our analysis of two waves of experimental data (i.e., before and after the peak of the COVID-19 pandemic) shows that the COVID-19 pandemic has further enhanced the nudging effect of blood users' demand information and official information sources. These findings provide a theoretical basis and policy recommendations for relevant institutions to develop effective blood donation campaign strategies.",2021,An official information source has a greater influence on participants' donation intention than an unofficial source.,"[""Individuals' Blood Donation Intention"", '1,116 participants']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",[],[],1116.0,0.0268544,An official information source has a greater influence on participants' donation intention than an unofficial source.,"[{'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'China Academy of Corporate Governance, Business School, Nankai University, Tianjin, China.'}, {'ForeName': 'Shuaiqi', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'School of Finance, Shandong University of Finance and Economics, Jinan, China.'}, {'ForeName': 'Jianbiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Institute for Study of Brain-like Economics, School of Economics, Shandong University, Jinan, China.'}, {'ForeName': 'Yujun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Economic and Management, Nankai University Binhai College, Tianjin, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.736002']
3025,34765401,Resistance exercise training with protein supplementation improves skeletal muscle strength and improves quality of life in late adolescents and young adults with Barth syndrome: A pilot study.,"Background


Muscle weakness and exercise intolerance contribute to reduced quality of life (QOL) in Barth syndrome (BTHS). Our group previously found that 12 weeks of resistance exercise training (RET) improved muscle strength, however, did not increase muscle (lean) mass or QOL in n = 3 young adults with BTHS. The overall objective of this pilot study was to examine the safety and effectiveness of RET plus daily protein supplementation (RET + protein) on muscle strength, skeletal muscle mass, exercise tolerance, cardiac function, and QOL in late adolescents/young adults with BTHS.
Methods


Participants with BTHS (n = 5, age 27 ± 7) performed 12 weeks of supervised RET (60 minutes per session, three sessions/week) and consumed 42 g/day of whey protein. Muscle strength, muscle mass, exercise capacity, cardiac function, and health-related QOL were assessed pre-post intervention.
Results


RET + protein was safe, increased muscle strength and quality of life, and tended to increase lean mass.
Conclusions


RET + protein appears safe, increases muscle strength and quality of life and tends to increase lean mass. Larger studies are needed to confirm these findings and to fully determine the effects of RET + protein in individuals with BTHS.",2021,"Muscle strength, muscle mass, exercise capacity, cardiac function, and health-related QOL were assessed pre-post intervention.
","['late adolescents/young adults with BTHS', 'individuals with BTHS', 'Methods\n\n\nParticipants with BTHS', 'late adolescents and young adults with Barth syndrome', 'Barth syndrome (BTHS']","['resistance exercise training (RET', 'RET plus daily protein supplementation (RET\u2009+\u2009protein', 'supervised RET', 'Resistance exercise training with protein supplementation']","['quality of life', 'muscle strength, skeletal muscle mass, exercise tolerance, cardiac function, and QOL', 'muscle strength', 'quality of life (QOL', 'skeletal muscle strength', 'muscle (lean) mass or QOL', 'muscle strength and quality of life', 'Muscle strength, muscle mass, exercise capacity, cardiac function, and health-related QOL']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0574083', 'cui_str': '3-Methylglutaconic aciduria type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",3.0,0.0176044,"Muscle strength, muscle mass, exercise capacity, cardiac function, and health-related QOL were assessed pre-post intervention.
","[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Bohnert', 'Affiliation': 'Program in Physical Therapy Washington University School of Medicine St. Louis Missouri USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ditzenberger', 'Affiliation': 'Doctor of Physical Therapy Division Duke University School of Medicine Durham North Carolina USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Bittel', 'Affiliation': 'Program in Physical Therapy Washington University School of Medicine St. Louis Missouri USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'de Las Fuentes', 'Affiliation': 'Department of Medicine Washington University School of Medicine St. Louis Missouri USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Corti', 'Affiliation': 'Department of Pediatrics University of Florida School of Medicine Gainesville Florida USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Pacak', 'Affiliation': 'Department of Pediatrics University of Florida School of Medicine Gainesville Florida USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Department of Pediatrics Medical University of South Carolina Chaleston South Carolina USA.'}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Byrne', 'Affiliation': 'Department of Pediatrics University of Florida School of Medicine Gainesville Florida USA.'}, {'ForeName': 'Dominic N', 'Initials': 'DN', 'LastName': 'Reeds', 'Affiliation': 'Department of Medicine Washington University School of Medicine St. Louis Missouri USA.'}, {'ForeName': 'W Todd', 'Initials': 'WT', 'LastName': 'Cade', 'Affiliation': 'Program in Physical Therapy Washington University School of Medicine St. Louis Missouri USA.'}]",JIMD reports,['10.1002/jmd2.12244']
3026,34765324,Using Wearables and Machine Learning to Enable Personalized Lifestyle Recommendations to Improve Blood Pressure.,"Background:  Blood pressure (BP) is an essential indicator for human health and is known to be greatly influenced by lifestyle factors, like activity and sleep factors. However, the degree of impact of each lifestyle factor on BP is unknown and may vary between individuals. Our goal is to investigate the relationships between BP and lifestyle factors and provide personalized and precise recommendations to improve BP, as opposed to the current practice of general lifestyle recommendations.  Method:  Our proposed system consists of automated data collection using home BP monitors and wearable activity trackers and feature engineering techniques to address time-series data and enhance interpretability. We propose Random Forest with Shapley-Value-based Feature Selection to offer personalized BP modeling and top lifestyle factor identification, and subsequent generation of precise recommendations based on the top factors.  Result:  In collaboration with UC San Diego Health and Altman Clinical and Translational Research Institute, we performed a clinical study, applying our system to 25 patients with elevated BP or stage I hypertension for three consecutive months. Our study results validate our system's ability to provide accurate personalized BP models and identify the top features which can vary greatly between individuals. We also validate the effectiveness of personalized recommendations in a randomized controlled experiment. After receiving recommendations, the subjects in the experimental group decreased their BPs by 3.8 and 2.3 for systolic and diastolic BP, compared to the decrease of 0.3 and 0.9 for the subjects without recommendations.  Conclusion:  The study demonstrates the potential of using wearables and machine learning to develop personalized models and precise lifestyle recommendations to improve BP.",2021,"After receiving recommendations, the subjects in the experimental group decreased their BPs by 3.8 and 2.3 for systolic and diastolic BP, compared to the decrease of 0.3 and 0.9 for the subjects without recommendations.  ",['25 patients with elevated BP or stage'],[':  Blood pressure (BP'],"['BPs', 'Blood Pressure', 'systolic and diastolic BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C1849718', 'cui_str': 'Autosomal recessive popliteal pterygium syndrome'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",25.0,0.0451254,"After receiving recommendations, the subjects in the experimental group decreased their BPs by 3.8 and 2.3 for systolic and diastolic BP, compared to the decrease of 0.3 and 0.9 for the subjects without recommendations.  ","[{'ForeName': 'Po-Han', 'Initials': 'PH', 'LastName': 'Chiang', 'Affiliation': 'Mobile Systems Design LaboratoryDepartment of Electrical and Computer EngineeringUniversity of California at San Diego La Jolla CA 92092 USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Department of MedicineUniversity of California at San Diego La Jolla CA 92092 USA.'}, {'ForeName': 'Sujit', 'Initials': 'S', 'LastName': 'Dey', 'Affiliation': 'Mobile Systems Design LaboratoryDepartment of Electrical and Computer EngineeringUniversity of California at San Diego La Jolla CA 92092 USA.'}]",IEEE journal of translational engineering in health and medicine,['10.1109/JTEHM.2021.3098173']
3027,34765257,Enhancing LPG Adoption in Ghana (ELAG): A Trial Testing Policy-Relevant Interventions to Increase Sustained Use of Clean Fuels.,"Rural Ghanaians rely on solid biomass fuels for their cooking. National efforts to promote the Sustainable Development Goals include the Rural Liquefied Petroleum Gas Promotion Program (RLP), which freely distributes LPG stoves, but evaluations have demonstrated low sustained use among recipients. Our study objective was to assess if cheap and scalable add-on interventions could increase sustained use of LPG stoves under the RLP scheme. We replicated RLP conditions among participants in 27 communities in Kintampo, Ghana, but cluster-randomized them to four add-on interventions: a behavioral intervention, fuel delivery service, combined intervention, or control. We reported on the final 6 months of a 12-month follow-up for participants ( n  = 778). Results demonstrated increased use for each intervention, but magnitudes were small. The direct delivery intervention induced the largest increase: 280 min over 6 months ( p  < 0.001), ∼1.5 min per day. Self-reported refills (a secondary outcome), support increased use for the dual intervention arm (IRR = 2.2,  p  = 0.026). Past literature demonstrates that recipients of clean cookstoves rarely achieve sustained use of the technologies. While these results are statistically significant, we interpret them as null given the implied persistent reliance on solid fuels. Future research should investigate if fuel subsidies would increase sustained use since current LPG promotion activities do not.",2021,"The direct delivery intervention induced the largest increase: 280 min over 6 months ( p  < 0.001), ∼1.5 min per day.","['Ghana (ELAG', 'participants in 27 communities in Kintampo, Ghana, but cluster-randomized them to four add-on interventions: a']","['behavioral intervention, fuel delivery service, combined intervention, or control']",[],"[{'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0206063,"The direct delivery intervention induced the largest increase: 280 min over 6 months ( p  < 0.001), ∼1.5 min per day.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Carrión', 'Affiliation': 'Department of Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Prah', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Tawiah', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Agyei', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Mieks', 'Initials': 'M', 'LastName': 'Twumasi', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Mujtaba', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Darby', 'Initials': 'D', 'LastName': 'Jack', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Kwaku Poku', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}]",Sustainability,['10.3390/su13042213']
3028,34765522,Beneficial effect of mindfulness based stress reduction on optic disc perfusion in primary open angle glaucoma: A randomized controlled trial.,"Background and aim


Glaucoma is one of the leading causes of visual impairment worldwide. Next to intraocular pressure (IOP), vascular factors play a major role in glaucoma. Mindfulness-based stress reduction (MBSR) has been shown to reduce the IOP, normalize the stress biomarkers, modulate gene expression, and also improve the quality of life. This study was aimed to assess the effect of MBSR in optic disc perfusion of patients with primary open angle glaucoma (POAG).
Experimental procedure


POAG patients with controlled IOP (<21 mmHg) were randomised in to intervention group (n = 30) and control group (n = 30). Both the groups continued their routine glaucoma medications while the intervention group practiced 45 min of MBSR every day in addition. IOP and optic disc perfusion using OCT-Angiography were recorded at baseline and at 6 weeks for both the groups.
Results


The mean age of the participants were 53.23 ± 8.4yr in intervention and 50.23 ± 7.3yr in the control group (p = 0.06). All the baseline parameters were comparable in both groups. After MBSR, in the intervention group there was a significant reduction of IOP (p=0.001), increase in circum-papillary vessel density in superior quadrant (15.8%-17.4%, p=0.02) and nasal quadrant (14.2%-16.5%, p=0.01), increase in circum papillary vascular perfusion, in superior quadrant (38.9%-41.1%, p<0.001), in temporal quadrant (42.2%-44.5%, p<0.001), in inferior quadrant (40.1%-43.8%, p<0.001), and in nasal quadrant (40.6%-42.8%, p<0.001). There was also a significant increase in Flux Index after 6weeks (0.38-0.40, p<0.001).
Conclusion


MBSR can reduce barotrauma and improve optic disc perfusion in POAG patients and serve as a useful adjunct to the standard medical therapy.",2021,"After MBSR, in the intervention group there was a significant reduction of IOP (p=0.001), increase in circum-papillary vessel density in superior quadrant (15.8%-17.4%, p=0.02) and nasal quadrant (14.2%-16.5%, p=0.01), increase in circum papillary vascular perfusion, in superior quadrant (38.9%-41.1%, p<0.001), in temporal quadrant (42.2%-44.5%, p<0.001), in inferior quadrant (40.1%-43.8%, p<0.001), and in nasal quadrant (40.6%-42.8%, p<0.001).","['patients with primary open angle glaucoma (POAG', 'Experimental procedure\n\n\nPOAG patients with controlled IOP (<21\xa0mmHg', 'The mean age of the participants were 53.23\xa0±', 'primary open angle glaucoma']","['Mindfulness-based stress reduction (MBSR', 'MBSR', 'mindfulness based stress reduction']","['quality of life', 'nasal quadrant', 'IOP and optic disc perfusion using OCT-Angiography', 'Flux Index', 'circum-papillary vessel density in superior quadrant', 'circum papillary vascular perfusion, in superior quadrant', 'IOP', 'optic disc perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]",,0.0641444,"After MBSR, in the intervention group there was a significant reduction of IOP (p=0.001), increase in circum-papillary vessel density in superior quadrant (15.8%-17.4%, p=0.02) and nasal quadrant (14.2%-16.5%, p=0.01), increase in circum papillary vascular perfusion, in superior quadrant (38.9%-41.1%, p<0.001), in temporal quadrant (42.2%-44.5%, p<0.001), in inferior quadrant (40.1%-43.8%, p<0.001), and in nasal quadrant (40.6%-42.8%, p<0.001).","[{'ForeName': 'Tanuj', 'Initials': 'T', 'LastName': 'Dada', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Brajesh', 'Initials': 'B', 'LastName': 'Lahri', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Karthikeyan', 'Initials': 'K', 'LastName': 'Mahalingam', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Shakrawal', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ramanjit', 'Initials': 'R', 'LastName': 'Sihota', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Raj Kumar', 'Initials': 'RK', 'LastName': 'Yadav', 'Affiliation': 'Integral Health Clinic, Department of Physiology, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of traditional and complementary medicine,['10.1016/j.jtcme.2021.06.006']
3029,34765519,"Early intervention with Kan Jang® to treat upper-respiratory tract infections: A randomized, quadruple-blind study.","Background and aim


Andrographis paniculata  and  Eleutherococcus senticosus  preparations and their fixed combination, called Kan Jang®, are traditionally used for relieving symptoms of upper-respiratory tract infections (URTIs). This study aimed to assess the efficacy of early intervention with Kan Jang® on the relief and duration of inflammatory symptoms during the acute phase of the disease.
Experimental procedure


A total of 179 patients with URTI symptoms received six Kan Jang® (daily dose of andrographolides: 60 mg) or placebo capsules a day for five consecutive days in this randomized, quadruple-blinded, placebo-controlled, two-parallel-group phase II study. The primary efficacy outcomes were the decrease in the acute-phase duration and the mean URTI symptoms score (sore throat, runny nose, nasal congestion, hoarseness, cough, headache, and fatigue).
Results


Early intervention with Kan Jang® significantly increased the recovery rate and reduced the number of sick leave days by >21% (0.64/day) relative to that observed in the placebo group (2.38 vs. 3.02 days, p = 0.0053). Kan Jang® significantly alleviated all URTI symptoms starting from the second day of treatment. A superior anti-inflammatory effect of Kan Jang® to that of placebo was also observed on the white blood cell count (p = 0.007) and erythrocyte sedimentation rate (p = 0.0258). Treatment with Kan Jang® was tolerated well.
Conclusion


This study demonstrates that early intervention with Kan Jang® capsules reduces the recovery duration of patients by 21% and significantly relieves the severity of typical URTI symptoms.",2021,"Early intervention with Kan Jang® significantly increased the recovery rate and reduced the number of sick leave days by >21% (0.64/day) relative to that observed in the placebo group (2.38 vs. 3.02 days, p = 0.0053).",['179 patients with URTI symptoms'],"['six Kan Jang® (daily dose of andrographolides: 60\xa0mg) or placebo', 'placebo', 'Kan Jang®']","['recovery duration', 'relief and duration of inflammatory symptoms', 'white blood cell count', 'recovery rate', 'erythrocyte sedimentation rate', 'severity of typical URTI symptoms', 'number of sick leave days', 'acute-phase duration and the mean URTI symptoms score (sore throat, runny nose, nasal congestion, hoarseness, cough, headache, and fatigue']","[{'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0574287', 'cui_str': 'Kanarese language'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0051821', 'cui_str': 'andrographolide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",179.0,0.0712843,"Early intervention with Kan Jang® significantly increased the recovery rate and reduced the number of sick leave days by >21% (0.64/day) relative to that observed in the placebo group (2.38 vs. 3.02 days, p = 0.0053).","[{'ForeName': 'Mikayel', 'Initials': 'M', 'LastName': 'Narimanyan', 'Affiliation': 'Yerevan State Medical University of Armenia, Koryun 2, RA-0025 Yerevan, Armenia.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Jamalyan', 'Affiliation': 'Erebouni Medical Center, 14 Titogradyan Str, RA-0087 Yerevan, Armenia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Balyan', 'Affiliation': 'Yerevan State Medical University of Armenia, Koryun 2, RA-0025 Yerevan, Armenia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Barth', 'Affiliation': 'Partus Kvinnohälsa, Korsgatan 4, SE-411 16 Göteborg, Sweden.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Palm', 'Affiliation': 'Panafarma Medical Consult AB, Skottorps Castle, SE-312 96 Laholm, Sweden.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Wikman', 'Affiliation': 'SHI Research and Development AB, Kövlingevägen 21, SE-312 50 Vallberga, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Panossian', 'Affiliation': 'Phytomed AB, Bofinkvägen 1, Våxtorp 31275, Sweden.'}]",Journal of traditional and complementary medicine,['10.1016/j.jtcme.2021.06.001']
3030,34765482,The metabolic effects of multi-trace elements on parenteral nutrition for critically ill pediatric patients: a randomized controlled trial and metabolomic research.,"Background


We investigated the efficacy and metabolic dose-effect of multi-trace element injection I [MTEI-(I)] for severe pediatric patients via a parallel, randomized control study.
Methods


The inclusion criteria were as follows: (I) patients who required parenteral nutrition (PN) due to various diseases, and were expected to receive PN for >5 days; (II) patients aged <18 years; (III) patients with no serious cardiac, hepatic, renal, or pulmonary dysfunction; and (IV) patients with an established central venous pathway. Enrolled patients were randomly assigned into two groups using sequentially numbered, sealed, opaque envelopes: Group A (low-dose group) received MTEI-(I) at 1 mL/kg/d, and Group B (high-dose group) received MTEI-(I) at 2 mL/kg/d, up to a maximum dose of 15 mL/d. The concentrations of manganese (Mn), copper (Cu), zinc (Zn), and selenium (Se) were detected. The following indexes were measured after 5 days of treatment (T5): β-oxidation of very-long-chain fatty acids, arginine and proline metabolism, pentose phosphate metabolism, ketone body metabolism, citric acid cycle, purine metabolism, caffeine metabolism, and pyruvate metabolism. The participants, care givers, and data analysis staff were blinded to the group assignment.
Results


Overall, at T5, Mn and Cu levels were decreased, while Zn and Se levels were increased. The increase of Zn levels (A: 0.170±0.479  vs.  B: 0.193±0.900) and decrease of Cu levels (A: -0.240±0.382  vs.  B: -0.373±0.465) of patients in Group B (n=22) were significantly higher than those in Group A (n=18). At T5, the β-oxidation of very-long-chain fatty acids, arginine and proline metabolism, pentose phosphate metabolism, ketone body metabolism, citric acid cycle, purine metabolism, caffeine metabolism, and pyruvate metabolism were variably decreased (P<0.05) in Group B compared to Group A.
Conclusions


Our results suggested that the high-dose administration of MTEI-(I) is safe for severe pediatric patients, and may alleviate inflammation and antioxidation, relieve hyperactivity caused by stress, and improve tissues-based hypoxia and renal function.
Trial Registration


Chinese Clinical Trial Registry ChiCTR2100052198.",2021,The increase of Zn levels (A: 0.170±0.479  vs.  B: 0.193±0.900) and decrease of Cu levels (A: -0.240±0.382  vs.  B: -0.373±0.465) of patients in Group B (n=22) were significantly higher than those in Group A (n=18).,"['severe pediatric patients via a parallel, randomized control study', 'severe pediatric patients', 'I) patients who required parenteral nutrition (PN) due to various diseases, and were expected to receive PN for >5 days; (II) patients aged <18 years; (III) patients with no serious cardiac, hepatic, renal, or pulmonary dysfunction; and (IV) patients with an established central venous pathway', 'critically ill pediatric patients']","['multi-trace element injection', 'MTEI-(I', 'multi-trace elements']","['β-oxidation of very-long-chain fatty acids, arginine and proline metabolism, pentose phosphate metabolism, ketone body metabolism, citric acid cycle, purine metabolism, caffeine metabolism, and pyruvate metabolism', 'Zn levels', 'Cu levels', 'concentrations of manganese (Mn), copper (Cu), zinc (Zn), and selenium (Se', 'Overall, at T5, Mn and Cu levels', 'Zn and Se levels']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0444466', 'cui_str': 'Central venous'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0443566', 'cui_str': 'Very long chain fatty acids measurement'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0030893', 'cui_str': 'Pentosephosphates'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0008858', 'cui_str': 'Krebs cycle pathway'}, {'cui': 'C0034140', 'cui_str': 'Purines'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0373748', 'cui_str': 'Zinc measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024706', 'cui_str': 'Manganese'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0373721', 'cui_str': 'Selenium measurement'}]",22.0,0.124443,The increase of Zn levels (A: 0.170±0.479  vs.  B: 0.193±0.900) and decrease of Cu levels (A: -0.240±0.382  vs.  B: -0.373±0.465) of patients in Group B (n=22) were significantly higher than those in Group A (n=18).,"[{'ForeName': 'Qingti', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': ""Pediatric Intensive Care Unit, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Institute for Emergency and Disaster Medicine, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Pediatric Intensive Care Unit, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': ""Pediatric Intensive Care Unit, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ""Pediatric Intensive Care Unit, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Tao', 'Affiliation': ""Pediatric Intensive Care Unit, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Institute for Emergency and Disaster Medicine, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Nutrition, Department of Health Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Translational pediatrics,['10.21037/tp-21-456']
3031,34765467,Early high-energy feeding in infants following cardiac surgery: a randomized controlled trial.,"Background


Effective nutrition programs are beneficial for nutritional recovery in infants. Few studies have focused on the effect of early high-energy feeding after open heart surgery. This study sought to assess the effects of early high-energy feeding in infants after congenital heart surgery.
Methods


Patients at a tertiary pediatric cardiology center who underwent open heart surgery between July 2016 and July 2018 were recruited and randomly allocated to 1 of the following 2 groups: (I) the intervention group (postoperative early high-energy feeding; n=124); and (II) the control group (no intervention; n=120).The primary endpoints of average energy delivery and growth Z-scores [i.e., weight-for-height Z-score (WHZ), weight-for-age Z-score (WAZ), and height-for-age Z-score (HAZ)] were recorded preoperatively, during the intensive care unit (ICU) stay, at discharge, and at 1 and 3 months postoperatively. The secondary endpoints of malnutrition recovery, ventilator support time, infection rate, and cardiac ICU (CICU) stay were also recorded.
Results


A total of 244 infants were included in the study. There were no significant differences in the baseline features between the 2 groups. The intervention group received higher calories on average than the control group (44.5  vs.  34.7; P<0.001). At discharge from the ICU, the WHZ (-2.29  vs.  -2.76; P<0.001) and WAZ (-3.08  vs.  -3.43; P=0.005) of patients in the intervention group were higher than those of patients in the control group. Ventilator support time (P=0.004), CICU stay (P=0.045), and infection rate (P=0.001) were significantly lower in the intervention group than the control group. At 3 months post-surgery, the intervention group exhibited a higher malnutrition recovery rate than the control group (19.4%  vs.  6.5%; P=0.002).
Conclusions


The administration of early high-energy feeding to infants after congenital heart surgery is associated with improved growth, reduced CICU stay, decreased ventilator support time, and reduced postoperative infection rates.
Trial Registration


ClinicalTrials NCT04609358.",2021,"Ventilator support time (P=0.004), CICU stay (P=0.045), and infection rate (P=0.001) were significantly lower in the intervention group than the control group.","['infants after congenital heart surgery', 'infants', '244 infants were included in the study', 'Methods\n\n\nPatients at a tertiary pediatric cardiology center who underwent open heart surgery between July 2016 and July 2018', 'infants following cardiac surgery']",[],"['improved growth, reduced CICU stay, decreased ventilator support time', 'Ventilator support time', 'CICU stay', 'postoperative infection rates', 'infection rate', 'malnutrition recovery rate', 'average energy delivery and growth Z-scores [i.e., weight-for-height Z-score (WHZ), weight-for-age Z-score (WAZ), and height-for-age Z-score (HAZ', 'malnutrition recovery, ventilator support time, infection rate, and cardiac ICU (CICU) stay']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C1321166', 'cui_str': 'Pediatric cardiology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]",[],"[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0587446', 'cui_str': 'Cardiac intensive care unit'}]",244.0,0.0490288,"Ventilator support time (P=0.004), CICU stay (P=0.045), and infection rate (P=0.001) were significantly lower in the intervention group than the control group.","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Mingjie', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yixiao', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Zhuoming', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Bao', 'Affiliation': ""Department of Pediatric Surgery, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}]",Translational pediatrics,['10.21037/tp-21-360']
3032,34768608,Effect of Neuromuscular Blockade on Intraoperative Respiratory Mechanics and Surgical Space Conditions during Robot-Assisted Radical Prostatectomy: A Prospective Randomized Controlled Trial.,"The aim of this study was to investigate whether deep neuromuscular blockade (NMB) may affect intraoperative respiratory mechanics, surgical condition, and recovery profiles in patients undergoing robot-assisted radical prostatectomy (RARP). Patients were randomly assigned to the moderate or deep NMB groups. Pneumoperitoneum was maintained with carbon dioxide (CO 2 ) insufflation at 15 mmHg during surgery. The primary outcome was peak inspiratory pressure (PIP) after CO 2  insufflation. Mean airway pressure (P mean ) and dynamic lung compliance (C dyn ) were also recorded. The surgeon rated the surgical condition and surgical difficulty on a five-point scale (1 = extremely poor; 2 = poor; 3 = acceptable; 4 = good; 5 = optimal). Recovery profiles, such as pulmonary complications, pain scores, and recovery time, were recorded. We included 58 patients in this study. No significant differences were observed regarding intraoperative respiratory mechanics including PIP, P mean  and C dyn , between the two groups. The number of patients with optimal surgical conditions was significantly higher in the deep than in the moderate NMB group (29 vs. 20,  p  = 0.014). We found no differences in recovery profiles. In conclusion, deep NMB had no significant effect on the intraoperative respiratory mechanics but resulted in optimal endoscopic surgical conditions during RARP compared with moderate NMB.",2021,"No significant differences were observed regarding intraoperative respiratory mechanics including PIP, P mean  and C dyn , between the two groups.","['patients undergoing', '58 patients in this study']","['deep neuromuscular blockade (NMB', 'carbon dioxide (CO 2 ) insufflation', 'Neuromuscular Blockade', 'Robot-Assisted Radical Prostatectomy', 'robot-assisted radical prostatectomy (RARP']","['Recovery profiles, such as pulmonary complications, pain scores, and recovery time', 'intraoperative respiratory mechanics', 'peak inspiratory pressure (PIP', 'Intraoperative Respiratory Mechanics and Surgical Space Conditions', 'number of patients with optimal surgical conditions', 'intraoperative respiratory mechanics including PIP, P mean  and C dyn', 'Mean airway pressure (P mean ) and dynamic lung compliance (C dyn ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0600130', 'cui_str': 'dyne'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0024112', 'cui_str': 'Lung compliance'}]",58.0,0.169296,"No significant differences were observed regarding intraoperative respiratory mechanics including PIP, P mean  and C dyn , between the two groups.","[{'ForeName': 'Chang-Hoon', 'Initials': 'CH', 'LastName': 'Koo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam 13620, Korea.'}, {'ForeName': 'Insun', 'Initials': 'I', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam 13620, Korea.'}, {'ForeName': 'Sungmin', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam 13620, Korea.'}, {'ForeName': 'Sangchul', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Seoul National University Bundang Hospital, Seongnam 13620, Korea.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam 13620, Korea.'}]",Journal of clinical medicine,['10.3390/jcm10215090']
3033,34768600,"Comparative Study between the Combination of Dexamethasone and Bupivacaine for Third Molar Surgery Postoperative Pain: A Triple-Blind, Randomized Clinical Trial.","Objectives:  To compare the possible benefits of the combination of dexamethasone-bupivacaine with articaine-epinephrine as an anaesthetic block after third molar surgery.  Materials and Methods:  Triple-blind, randomized, controlled, parallel, phase 3 clinical trial. Two groups: experimental (93 patients) with standard anaesthetic block: 40/0.005 mg/mL articaine-epinephrine and submucosal reinforcement with 0.8 mg dexamethasone-5% bupivacaine; and control group (91 patients) with standard block: 40/0.005 mg/mL articaine-epinephrine. The surgery consisted of the extraction of the impacted mandibular third molar by performing a procedure following the same repeatable scheme. The visual analogue scale (VAS) was used to analyse postoperative pain.  Results:  Groups were homogeneous, without significant differences related to epidemiological variables. Postoperative pain among the first, second, and seventh postoperative days was statistically significantly lower in the experimental group compared to the control group ( p  < 0.001). Drug consumption was lower in the experimental group throughout the study period ( p  < 0.04).  Conclusion:  Bupivacaine is an alternative to articaine in oral surgery, being more effective in reducing postoperative pain by reducing patients' scores on the VAS as well as their consumption of analgesic drugs after surgery.",2021,"Postoperative pain among the first, second, and seventh postoperative days was statistically significantly lower in the experimental group compared to the control group ( p  < 0.001).",['Third Molar Surgery Postoperative Pain'],"['standard block: 40/0.005 mg/mL articaine-epinephrine', 'Bupivacaine', 'articaine-epinephrine', 'articaine', 'Dexamethasone and Bupivacaine', 'standard anaesthetic block: 40/0.005 mg/mL articaine-epinephrine and submucosal reinforcement with 0.8 mg dexamethasone-5% bupivacaine', 'dexamethasone-bupivacaine']","['Postoperative pain', 'Drug consumption', 'visual analogue scale (VAS', 'postoperative pain']","[{'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0939218', 'cui_str': 'Articaine- and epinephrine-containing product'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.169345,"Postoperative pain among the first, second, and seventh postoperative days was statistically significantly lower in the experimental group compared to the control group ( p  < 0.001).","[{'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Quesada-Bravo', 'Affiliation': 'Maxillofacial Surgeons of Department of Oral and Maxillofacial Surgery, Torrecardenas University Hospital, 04009 Almeria, Spain.'}, {'ForeName': 'Ana Rocío', 'Initials': 'AR', 'LastName': 'García-Carricondo', 'Affiliation': 'Maxillofacial Surgeons of Department of Oral and Maxillofacial Surgery, Torrecardenas University Hospital, 04009 Almeria, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Espín-Gálvez', 'Affiliation': 'Maxillofacial Surgeons of Department of Oral and Maxillofacial Surgery, Torrecardenas University Hospital, 04009 Almeria, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Fernández-Sánchez', 'Affiliation': 'Department of Clinical Pharmacology, Torrecardenas University Complex, 04009 Almeria, Spain.'}, {'ForeName': 'Damaso', 'Initials': 'D', 'LastName': 'Fernández-Ginés', 'Affiliation': 'Department of Clinical Pharmacology, Torrecardenas University Complex, 04009 Almeria, Spain.'}, {'ForeName': 'María Del Mar', 'Initials': 'MDM', 'LastName': 'Requena-Mullor', 'Affiliation': 'Department of Nursing, Physiotherapy and Medicine, University of Almería, 04120 Almería, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Alarcón-Rodríguez', 'Affiliation': 'Department of Nursing, Physiotherapy and Medicine, University of Almería, 04120 Almería, Spain.'}]",Journal of clinical medicine,['10.3390/jcm10215081']
3034,34768592,Improvements in the Effectiveness of Early Detection in Colorectal Cancer with Open-Label Randomised Study.,"INTRODUCTION


The general objective of this research is to improve the quality of colorectal cancer screening (CRC) by assessing, as an indicator of effectiveness, the ability of colonoscopy to detect more advanced adenomas in the exposed group than in the control group.
MATERIAL AND METHODS


The present work is designed as an open-label randomized study on cancer screening, using two groups based on their exposure to the protocol: an exposed to intervention group (EIG, 167), and a control group (CG, 167), without the intervention of the protocol and by 1:1 matching.
RESULTS


In 167 patients in the GEI, 449 polyps are visualized and 274 are adenomas (80.58%), of which 100 (36.49%) are advanced adenomas. In the CG ( n  = 174), there are 321 polyps and 152 adenomas (82.60%). The variables significantly associated by logistic regression to the detection of adenomas are the male sex with an OR of 2.52. The variable time to withdrawal, ≥9 min, is significant at 99% confidence ( p  = 0.002/OR 34.67) and the fractional dose is significant at 99% ( p  = 0.009, OR 7.81).
CONCLUSION


Based on the observations made, our study suggests that the intervention in collaboration between primary care and hospital care is effective from a preventive point of view and achieves the objective of effectiveness and quality of the PCCR.",2021,"The variable time to withdrawal, ≥9 min, is significant at 99% confidence ( p  = 0.002/OR 34.67) and the fractional dose is significant at 99% ( p  = 0.009, OR 7.81).
","['167 patients in the GEI, 449 polyps are visualized and 274 are adenomas (80.58%), of which 100 (36.49%) are advanced adenomas']",[],[],"[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]",[],[],,0.019643,"The variable time to withdrawal, ≥9 min, is significant at 99% confidence ( p  = 0.002/OR 34.67) and the fractional dose is significant at 99% ( p  = 0.009, OR 7.81).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Álvarez-Delgado', 'Affiliation': 'Digestive, Department of Medicine, University Hospital of Salamanca-IBSAL, University of Salamanca, 37007 Salamanca, Spain.'}, {'ForeName': 'M L Pérez', 'Initials': 'MLP', 'LastName': 'García', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), 37007 Salamanca, Spain.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'García-González', 'Affiliation': 'Department of Sociology, University Pablo of Olavide (Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'H Iglesias', 'Initials': 'HI', 'LastName': 'de Sena', 'Affiliation': 'Department of Biomedical and Diagnostic Sciences, School of Medicine, University of Salamanca, 37007 Salamanca, Spain.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Chamorro', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), 37007 Salamanca, Spain.'}, {'ForeName': 'M F Lorenzo', 'Initials': 'MFL', 'LastName': 'Gómez', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), 37007 Salamanca, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marcos', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), 37007 Salamanca, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Mirón-Canelo', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), 37007 Salamanca, Spain.'}]",Journal of clinical medicine,['10.3390/jcm10215072']
3035,34768588,Comprehensive Lifestyle Modification Influences Medium-Term and Artificially Induced Stress in Ulcerative Colitis-A Sub-Study within a Randomized Controlled Trial Using the Trier Social Stress Test.,"OBJECTIVE


The present study presents long-term results of stress-related outcomes of a prospective RCT that evaluated effects of a ten-week comprehensive lifestyle-modification program (LSM) in patients with inactive ulcerative colitis (UC). In addition, exploratory results of a sub-study applying a laboratory stress protocol (Trier Social Stress Test; TSST) conducted within the RCT are reported.
METHODS


Ninety-seven patients with inactive UC were randomized to LSM ( n  = 47; 50.28 ± 11.90 years; 72.3% female) or self-care ( n  = 50; 45.54 ± 12.49 years; 70% female). Patients' perceived stress, anxiety, flourishing and depression were assessed at week 0, 12, 24 and 48. After the respective intervention, 16 female patients (LSM:  n  = 8; 44.6 ± 14.3 years; Self-care:  n  = 8; 49.25 ± 4.30 years) additionally underwent the TSST. State anxiety, blood pressure, pulse, complete blood counts, adrenocorticotropic hormone (ACTH), cortisol, adrenalin and noradrenalin were measured at  baseline  (-15 min),  stress  (+10 min),  recovery1  (+20 min) and  recovery2  (+55 min). Statistical significance was set at  p  < 0.05; for the exploratory sub-study using the TSST,  p -values < 0.10 were considered significant.
RESULTS


Patients' perceived stress declined significantly after the LSM ( p  < 0.001) compared with control. This lasted until week 24 ( p  = 0.023) but did not persist until week 48 ( p  = 0.060). After 48 weeks, patients' flourishing was significantly increased compared with control ( p  = 0.006). In response to the TSST, significant group differences were evident for pulse ( p  = 0.015), adrenaline ( p  = 0.037) and anxiety ( p  = 0.066). After 55 min, group differences were found for ACTH ( p  = 0.067) and systolic blood pressure ( p  = 0.050).
CONCLUSIONS


LSM has a medium-term positive effect on perceived stress. First indications show that it is promising to investigate these effects further under laboratory conditions. It is also desirable to find out how the effects of LSM can be maintained in the long term.",2021,"After 55 min, group differences were found for ACTH ( p  = 0.067) and systolic blood pressure ( p  = 0.050).
","['Ninety-seven patients with inactive UC', ' n  = 47; 50.28 ± 11.90 years; 72.3% female) or self-care ( n  = 50; 45.54 ± 12.49 years; 70% female', 'patients with inactive ulcerative colitis (UC', '16 female patients (LSM:  n  = 8; 44.6 ± 14.3 years; Self-care:  n  = 8; 49.25 ± 4.30 years) additionally underwent the']","['TSST', 'Comprehensive Lifestyle Modification Influences Medium-Term and Artificially Induced Stress', 'LSM', 'adrenaline', 'comprehensive lifestyle-modification program (LSM']","['anxiety', 'stress', 'systolic blood pressure', 'stress, anxiety, flourishing and depression', 'State anxiety, blood pressure, pulse, complete blood counts, adrenocorticotropic hormone (ACTH), cortisol, adrenalin and noradrenalin']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]",97.0,0.0201293,"After 55 min, group differences were found for ACTH ( p  = 0.067) and systolic blood pressure ( p  = 0.050).
","[{'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Koch', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, 45276 Essen, Germany.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Schöls', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, 45276 Essen, Germany.'}, {'ForeName': 'Heidemarie', 'Initials': 'H', 'LastName': 'Haller', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, 45276 Essen, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Anheyer', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, 45276 Essen, Germany.'}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Cinar', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, 45276 Essen, Germany.'}, {'ForeName': 'Ronja', 'Initials': 'R', 'LastName': 'Eilert', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, 45276 Essen, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kofink', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, 45276 Essen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Engler', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, 45122 Essen, Germany.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Elsenbruch', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, Faculty of Medicine, Ruhr University, 44801 Bochum, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Cramer', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, 45276 Essen, Germany.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Dobos', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, 45276 Essen, Germany.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Langhorst', 'Affiliation': 'Department of Internal and Integrative Medicine, Klinikum Bamberg, Sozialstiftung Bamberg, 96049 Bamberg, Germany.'}]",Journal of clinical medicine,['10.3390/jcm10215070']
3036,34765635,Predictive Value of the Serum Albumin Level on Admission in Patients With Spontaneous Subarachnoid Hemorrhage.,"Objective:  To determine the effect of the serum albumin level on admission in patients with spontaneous subarachnoid hemorrhage (SAH).  Methods:  A total of 229 patients with SAH were divided into control and hypoalbuminemia groups. The serum albumin levels were measured. The data, including age, gender, co-existing medical conditions, risk factors, Hunt-Hess (H-H) grade on admission, Glasgow coma score (GCS) on admission, complications during hospitalizations, length of hospital stay, length of intensive care unit (ICU) stay, in-hospital mortality, survival rate, outcome at discharge, and the 6-month follow-up outcome, were compared between the two groups.  Results:  Older age, an increased number of patients who consumed an excess of alcohol, and a lower GCS on admission were findings in the hypoalbuminemia group compared to the control group ( p  < 0.001). The ratio of patients with H-H grade I on admission in the hypoalbuminemia group was decreased compared to the control group ( p  < 0.05). Patients with hypoalbuminemia were more likely to be intubated, and have pneumonia and cerebral vasospasm than patients with a normal albumin level on admission ( p  < 0.001). Furthermore, the length of hospital and ICU stays were longer in the hypoalbuminemia group than the control group ( p  < 0.001). Hypoalbuminemia on admission significantly increased poor outcomes at discharge ( p  < 0.001). The number of patients with severe disability was increased and the recovery rate was decreased with respect to in-hospital outcomes in the hypoalbuminemia group than the control group ( p  < 0.001).  Conclusion:  Hypoalbuminemia was shown to be associated with a poor prognosis in patients with SAH.",2021,The number of patients with severe disability was increased and the recovery rate was decreased with respect to in-hospital outcomes in the hypoalbuminemia group than the control group ( p  < 0.001).  ,"['patients with spontaneous subarachnoid hemorrhage (SAH', 'Patients With Spontaneous Subarachnoid Hemorrhage', 'patients with SAH', '229 patients with SAH']",[],"['pneumonia and cerebral vasospasm', 'recovery rate', 'risk factors, Hunt-Hess (H-H) grade on admission, Glasgow coma score (GCS) on admission, complications during hospitalizations, length of hospital stay, length of intensive care unit (ICU) stay, in-hospital mortality, survival rate, outcome at discharge, and the 6-month follow-up outcome', 'serum albumin levels', 'ratio of patients with H-H grade I on admission', 'length of hospital and ICU stays', 'number of patients with severe disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472383', 'cui_str': 'Spontaneous subarachnoid hemorrhage'}, {'cui': 'C0036001', 'cui_str': 'S-Adenosyl homocysteine'}]",[],"[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0265110', 'cui_str': 'Spasm of cerebral arteries'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",229.0,0.0654056,The number of patients with severe disability was increased and the recovery rate was decreased with respect to in-hospital outcomes in the hypoalbuminemia group than the control group ( p  < 0.001).  ,"[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shang', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Weitao', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital of Capital Medical University, Beijing, China.'}]",Frontiers in surgery,['10.3389/fsurg.2021.719226']
3037,34765612,Long-Term Effects of Financial Incentives for General Practitioners on Quality Indicators in the Treatment of Patients With Diabetes Mellitus in Primary Care-A Follow-Up Analysis of a Cluster Randomized Parallel Controlled Trial.,"Background:  The effect of financial incentives on the quality of primary care is of high interest, and so is its sustainability after financial incentives are withdrawn.  Objective:  To assess both long-term effects and sustainability of financial incentives for general practitioners (GPs) in the treatment of patients with diabetes mellitus based on quality indicators (QIs) calculated from routine data from electronic medical records.  Design/Participants:  Randomized controlled trial using routine data from electronic medical records of patients with diabetes mellitus of Swiss GPs.  Intervention:  During the study period of 24 months, all GPs received bimonthly feedback reports with information on their actual treatment as reflected in QIs. In the intervention group, the reports were combined with financial incentives for quality improvement. The incentive was stopped after 12 months.  Measurements:  Proportion of patients meeting the process QI of annual HbA1c measurements and the clinical QI of blood pressure levels below 140/85 mmHg.  Results:  A total of 71 GPs from 43 different practices were included along with 3,854 of their patients with diabetes mellitus. Throughout the study, the proportion of patients with annual HbA1c measurements was stable in the intervention group (78.8-78.9%) and decreased slightly in the control group (81.5-80.2%) [odds ratio (OR): 1.21; 95% CI: 1.04-1.42,  p  < 0.05]. The proportion of patients achieving blood pressure levels below 140/85 mmHg decreased in the control group (51.2-47.2%) and increased in the intervention group (49.7-51.9%) (OR: 1.18; 95% CI: 1.04-1.35,  p  < 0.05) where it peaked at 54.9% after 18 months and decreased steadily over the last 6 months.  Conclusion:  After the withdrawal of financial incentives for the GPs after 12 months, some QIs still improved, indicating that 1 year might be too short to observe the full effect of such interventions. The decrease in QI achievement rates after 18 months suggests that the positive effects of time-limited financial incentives eventually wane.",2021,"The proportion of patients achieving blood pressure levels below 140/85 mmHg decreased in the control group (51.2-47.2%) and increased in the intervention group (49.7-51.9%) (OR: 1.18; 95% CI: 1.04-1.35,  p  < 0.05) where it peaked at 54.9% after 18 months and decreased steadily over the last 6 months.  ","['A total of 71 GPs from 43 different practices were included along with 3,854 of their patients with diabetes mellitus', 'patients with diabetes mellitus based on quality indicators (QIs) calculated from routine data from electronic medical records', 'Patients', 'patients with diabetes mellitus of Swiss GPs']",['Financial Incentives'],"['QI achievement rates', 'Quality Indicators', 'proportion of patients achieving blood pressure levels', 'annual HbA1c measurements', 'clinical QI of blood pressure levels']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}]","[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",71.0,0.0658002,"The proportion of patients achieving blood pressure levels below 140/85 mmHg decreased in the control group (51.2-47.2%) and increased in the intervention group (49.7-51.9%) (OR: 1.18; 95% CI: 1.04-1.35,  p  < 0.05) where it peaked at 54.9% after 18 months and decreased steadily over the last 6 months.  ","[{'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Meier', 'Affiliation': 'Institute of Primary Care, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Chmiel', 'Affiliation': 'Institute of Primary Care, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Valeri', 'Affiliation': 'Institute of Primary Care, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Leander', 'Initials': 'L', 'LastName': 'Muheim', 'Affiliation': 'Institute of Primary Care, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Senn', 'Affiliation': 'Institute of Primary Care, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosemann', 'Affiliation': 'Institute of Primary Care, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}]",Frontiers in medicine,['10.3389/fmed.2021.664510']
3038,34765593,Development and Feasibility of a Kinect-Based Constraint-Induced Therapy Program in the Home Setting for Children With Unilateral Cerebral Palsy.,"Introduction:  Cerebral palsy (CP) is the leading cause of childhood-onset physical disability. Children with CP often have impaired upper limb (UL) function. Constraint-induced therapy (CIT) is one of the most effective UL interventions for children with unilateral CP. However, concerns about CIT for children have been repeatedly raised due to frustration caused by restraint of the child's less-affected UL and lack of motivation for the intensive protocol. Virtual reality (VR), which can mitigate the disadvantages of CIT, potentially can be used as an alternative mediator for implementing CIT. Therefore, we developed a VR-based CIT program for children with CP using the Kinect system.  Aims:  The feasibility of the Kinect-based CIT program was evaluated for children with unilateral CP using a two-phase study design.  Materials and Methods:  In phase 1, ten children with unilateral CP were recruited. To confirm the achievement of the motor training goals, maximal UL joint angles were evaluated during gameplay. To evaluate children's perceptions of the game, a questionnaire was used. In phase 2, eight children with unilateral CP were recruited and received an 8 weeks Kinect-based CIT intervention. Performance scores of the game and outcomes of the box and block test (BBT) were recorded weekly.  Results:  In phase 1, results supported that the design of the program was CIT-specific and was motivational for children with unilateral CP. In phase 2, game performance and the BBT scores began showing stable improvements in the fifth week of intervention.  Conclusion:  It suggested the Kinect-based CIT program was beneficial to the motor function of the affected UL for children with unilateral CP. According to the results of this feasibility study, larger and controlled effectiveness studies of the Kinect-based CIT program can be conducted to further improve its clinical utility.  Clinical Trial Registration:  ClinicalTrials.gov, NCT02808195; Comparative effectiveness of a Kinect-based unilateral arm training system vs. CIT for children with CP.",2021,"In phase 1, results supported that the design of the program was CIT-specific and was motivational for children with unilateral CP.","['ten children with unilateral CP were recruited', 'Children with CP often have impaired upper limb (UL) function', 'Children With Unilateral Cerebral Palsy', 'children with CP using the Kinect system', 'children with unilateral CP', 'eight children with unilateral CP', 'children with CP', 'children with unilateral CP using a two-phase study design']","['VR-based CIT program', 'Virtual reality (VR', 'Constraint-induced therapy (CIT', 'Kinect-Based Constraint-Induced Therapy Program', 'Kinect-based unilateral arm training system vs. CIT', 'Kinect-based CIT program', '8\xa0weeks Kinect-based CIT intervention']","['Performance scores of the game and outcomes of the box and block test (BBT', 'BBT scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",10.0,0.00763854,"In phase 1, results supported that the design of the program was CIT-specific and was motivational for children with unilateral CP.","[{'ForeName': 'Hao-Ling', 'Initials': 'HL', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Szu-Yu', 'Initials': 'SY', 'LastName': 'Lin', 'Affiliation': 'School of Occupational Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chun-Fu', 'Initials': 'CF', 'LastName': 'Yeh', 'Affiliation': 'School of Occupational Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Ren-Yu', 'Initials': 'RY', 'LastName': 'Chen', 'Affiliation': 'School of Occupational Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Hsien-Hui', 'Initials': 'HH', 'LastName': 'Tang', 'Affiliation': 'Department of Industrial and Commercial Design, National Taiwan University of Science and Technology, Taipei, Taiwan.'}, {'ForeName': 'Shanq-Jang', 'Initials': 'SJ', 'LastName': 'Ruan', 'Affiliation': 'Department of Electronic and Computer Engineering, National Taiwan University of Science and Technology, Taipei, Taiwan.'}, {'ForeName': 'Tien-Ni', 'Initials': 'TN', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, National Taiwan University, Taipei, Taiwan.'}]",Frontiers in bioengineering and biotechnology,['10.3389/fbioe.2021.755506']
3039,34765464,A clinical study on the tip localization of peripherally inserted central catheter (PICC) guided by intracavitary electrocardiography in newborns: a randomised trial.,"Background


The present study aimed to investigate the P-wave changes in intracavitary electrocardiography (IC-ECG) during catheterization with a peripherally inserted central catheter (PICC) in order to provide guidance for the accurate localization of the tip of the PICC.
Methods


A total of 106 newborns who needed a PICC were randomly divided into two groups-a study group and a control group-using a random number table, with 53 cases in each group. In the study group, the ECG monitor was connected after the successful puncture and insertion of the PICC into the right sternoclavicular joint, and the position of the catheter tip was determined according to the P-wave changes on the IC-ECG. Localization X-rays were taken at the same time. In the control group, after the successful routine puncture and insertion of the PICC into the location to a predetermined length, localization X-rays were taken. The accuracy, procedure duration, and cost of the two localization methods were evaluated.
Results


The accuracy of the localization in the study group was 92.5%, but the difference was not significant when compared with the control group (P>0.05). The duration of the procedure in the study group was 5.12±1.57 minutes, and the cost was 7.12±0.56 yuan, both of which were significantly different when compared with the control group (P<0.05).
Conclusions


P-wave changes during IC-ECG have high accuracy in determining the location of the tip of the PICC. It is also a simple method and has certain clinical application value.
Trial Registration


Chinese Clinical Trial Registry (number: ChiCTR2100047660).",2021,"The accuracy of the localization in the study group was 92.5%, but the difference was not significant when compared with the control group (P>0.05).","['106 newborns who needed a PICC', 'newborns']","['peripherally inserted central catheter (PICC) guided by intracavitary electrocardiography', 'catheterization with a peripherally inserted central catheter (PICC', 'intracavitary electrocardiography (IC-ECG']","['accuracy, procedure duration, and cost of the two localization methods', 'accuracy of the localization', 'duration of the procedure']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}]","[{'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1298613', 'cui_str': 'Intracavitary'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",106.0,0.149629,"The accuracy of the localization in the study group was 92.5%, but the difference was not significant when compared with the control group (P>0.05).","[{'ForeName': 'Li-Bo', 'Initials': 'LB', 'LastName': 'Zhu', 'Affiliation': ""Department of Neonatology, Kunming Children's Hospital, Kunming, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Neonatology, Kunming Children's Hospital, Kunming, China.""}, {'ForeName': 'Tie-Song', 'Initials': 'TS', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Kunming Children's Hospital, Kunming, China.""}, {'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Zheng', 'Affiliation': ""Department of Neonatology, Kunming Children's Hospital, Kunming, China.""}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Lu', 'Affiliation': ""Department of Neonatology, Kunming Children's Hospital, Kunming, China.""}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': ""Department of Neonatology, Kunming Children's Hospital, Kunming, China.""}, {'ForeName': 'Shu-Xian', 'Initials': 'SX', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Kunming Children's Hospital, Kunming, China.""}, {'ForeName': 'Liu-Yan', 'Initials': 'LY', 'LastName': 'Duan', 'Affiliation': ""Department of Neonatology, Kunming Children's Hospital, Kunming, China.""}, {'ForeName': 'Mei-Lin', 'Initials': 'ML', 'LastName': 'Yang', 'Affiliation': ""Department of Neonatology, Kunming Children's Hospital, Kunming, China.""}]",Translational pediatrics,['10.21037/tp-20-370']
3040,34765460,Subtypes of smokers in a randomized controlled trial of a web-based smoking cessation program and their role in predicting intervention non-usage attrition: Implications for the development of tailored interventions.,"Introduction


Web-based smoking interventions hold potential for smoking cessation; however, many of them report low intervention usage (i.e., high levels of non-usage attrition). One strategy to counter this issue is to tailor such interventions to user subtypes if these can be identified and related to non-usage attrition outcomes. The aim of this study was two-fold: (1) to identify and describe a smoker typology in participants of a web-based smoking cessation program and (2) to explore subtypes of smokers who are at a higher risk for non-usage attrition (i.e., early dropout times).
Methods


We conducted secondary analyses of data from a large randomized controlled trial (RCT) that investigated effects of a web-based Cognitive Bias Modification intervention in adult smokers. First, we conducted a two-step cluster analysis to identify subtypes of smokers based on participants' baseline characteristics (including demographics, psychological and smoking-related variables,  N  = 749). Next, we conducted a discrete-time survival analysis to investigate the predictive value of the subtypes on time until dropout.
Results


We found three distinct clusters of smokers: Cluster 1 (25.2%,  n  = 189) was characterized by participants being relatively young, highly educated, unmarried, light-to-moderate smokers, poly-substance users, and relatively high scores on sensation seeking and impulsivity; Cluster 2 (41.0%,  n  = 307) was characterized by participants being older, with a relatively high socio-economic status (SES), moderate-to-heavy smokers and regular drinkers; Cluster 3 (33.8%,  n  = 253) contained mostly females of older age, and participants were further characterized by a relatively low SES, heavy smoking, and relatively high scores on hopelessness, anxiety sensitivity, impulsivity, depression, and alcohol use. Additionally, Cluster 1 was more likely to drop out at the early stage of the intervention compared to Cluster 2 (adjusted Hazard Ratio ( HR   adjusted ) = 1.51,  95% CI  = [1.25, 1.83]) and Cluster 3 ( HR   adjusted  = 1.52,  95% CI  = [1.25, 1.86]).
Conclusions


We identified three clusters of smokers that differed on a broad range of characteristics and on intervention non-usage attrition patterns. This highlights the heterogeneity of participants in a web-based smoking cessation program. Also, it supports the idea that such interventions could be tailored to these subtypes to prevent non-usage attrition. The subtypes of smokers identified in this study need to be replicated in the field of e-health outside the context of RCT; based on the smoker subtypes identified in this study, we provided suggestions for developing tailored web-based smoking cessation intervention programs in future research.",2021,"We found three distinct clusters of smokers: Cluster 1 (25.2%,  n  = 189) was characterized by participants being relatively young, highly educated, unmarried, light-to-moderate smokers, poly-substance users, and relatively high scores on sensation seeking and impulsivity; Cluster 2 (41.0%,  n  = 307) was characterized by participants being older, with a relatively high socio-economic status (SES), moderate-to-heavy smokers and regular drinkers; Cluster 3 (33.8%,  n  = 253) contained mostly females of older age, and participants were further characterized by a relatively low SES, heavy smoking, and relatively high scores on hopelessness, anxiety sensitivity, impulsivity, depression, and alcohol use.","['adult smokers', 'participants of a web-based smoking cessation program and (2) to explore subtypes of smokers who are at a higher risk for non-usage attrition (i.e., early dropout times', 'participants being relatively young, highly educated, unmarried, light-to-moderate smokers, poly-substance users, and relatively high scores on sensation seeking and impulsivity; Cluster 2 (41.0%,  n \xa0=\xa0307) was characterized by participants being older, with a relatively high socio-economic status (SES), moderate-to-heavy smokers and regular drinkers; Cluster 3 (33.8%,  n \xa0=\xa0253) contained mostly females of older age, and participants were further characterized by a relatively low SES, heavy smoking, and relatively high scores on hopelessness, anxiety sensitivity, impulsivity, depression, and alcohol use']","['Introduction\n\n\nWeb-based smoking interventions', 'web-based smoking cessation program', 'web-based Cognitive Bias Modification intervention']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0338666', 'cui_str': 'Misuses drugs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C3494625', 'cui_str': 'Heavy tobacco smoker'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",[],,0.0822427,"We found three distinct clusters of smokers: Cluster 1 (25.2%,  n  = 189) was characterized by participants being relatively young, highly educated, unmarried, light-to-moderate smokers, poly-substance users, and relatively high scores on sensation seeking and impulsivity; Cluster 2 (41.0%,  n  = 307) was characterized by participants being older, with a relatively high socio-economic status (SES), moderate-to-heavy smokers and regular drinkers; Cluster 3 (33.8%,  n  = 253) contained mostly females of older age, and participants were further characterized by a relatively low SES, heavy smoking, and relatively high scores on hopelessness, anxiety sensitivity, impulsivity, depression, and alcohol use.","[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Addiction Development and Psychopathology (ADAPT)-lab, Department of Psychology, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Addiction Development and Psychopathology (ADAPT)-lab, Department of Psychology, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Marilisa', 'Initials': 'M', 'LastName': 'Boffo', 'Affiliation': 'Addiction Development and Psychopathology (ADAPT)-lab, Department of Psychology, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Raoul P P P', 'Initials': 'RPPP', 'LastName': 'Grasman', 'Affiliation': 'Programme group Psychological Methods, Department of Psychology, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pronk', 'Affiliation': 'Addiction Development and Psychopathology (ADAPT)-lab, Department of Psychology, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Larsen', 'Affiliation': 'Addiction Development and Psychopathology (ADAPT)-lab, Department of Psychology, University of Amsterdam, Amsterdam, the Netherlands.'}]",Internet interventions,['10.1016/j.invent.2021.100473']
3041,34765451,"Effect of tamsulosin versus tamsulosin plus tadalafil on renal calculus clearance after shock wave lithotripsy: An open-labelled, randomised, prospective study.","Objectives


To compare the efficacy of tamsulosin versus tamsulosin plus tadalafil in achieving clearance of fragments after shock wave lithotripsy (SWL) to treat renal calculi.
Methods


Between January 2016 to December 2017, 140 patients with solitary, non-branched, non-lower calyceal renal calculus and measuring less than 20 mm and treated with SWL were randomized to tamsulosin (group A) or tamsulosin plus tadalafil (group B). Therapy was given for a period of 4 weeks. Stone clearance rate, analgesic requirement, occurrence of steinstrasse, need for auxiliary procedures (endoscopic treatment), and adverse effects of drugs were recorded.
Results


The overall clearance rate was 72.5% (50/69) in the group A and 90.1% (64/71) in the group B ( p =0.007). For stones up to 12 mm, the difference in the clearance rate was significant ( p =0.039) while it was not so for stones larger than 12 mm ( p =0.151). There was no statistically significant difference between the two groups with regards to analgesic requirement ( p =0.94), occurrence of steinstrasse ( p =0.101), need for auxiliary procedures ( p =0.76), and adverse effects of the drugs ( p =0.148).
Conclusion


Our study shows that adjunctive medical expulsive therapy with tamsulosin and tadalafil achieves better clearance rate than tadalafil alone in patients receiving SWL for renal stones.",2021,"For stones up to 12 mm, the difference in the clearance rate was significant ( p =0.039) while it was not so for stones larger than 12 mm ( p =0.151).","['patients receiving SWL for renal stones', 'Methods\n\n\nBetween January 2016 to December 2017, 140 patients with solitary, non-branched, non-lower calyceal renal calculus and measuring less than 20\xa0mm and treated with SWL', 'after shock wave lithotripsy']","['tadalafil', 'tamsulosin', 'tamsulosin and tadalafil', 'tamsulosin plus tadalafil']","['clearance rate', 'overall clearance rate', 'need for auxiliary procedures', 'analgesic requirement', 'occurrence of steinstrasse', 'renal calculus clearance', 'adverse effects', 'Stone clearance rate, analgesic requirement, occurrence of steinstrasse, need for auxiliary procedures (endoscopic treatment), and adverse effects of drugs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0403714', 'cui_str': 'Calyceal renal calculus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0403718', 'cui_str': 'Steinstrasse'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",140.0,0.0299288,"For stones up to 12 mm, the difference in the clearance rate was significant ( p =0.039) while it was not so for stones larger than 12 mm ( p =0.151).","[{'ForeName': 'Siddalingeshwar', 'Initials': 'S', 'LastName': 'Neeli', 'Affiliation': 'Department of Urology, Jawaharlal Nehru Medical College, Belagavi, India.'}]",Asian journal of urology,['10.1016/j.ajur.2021.03.005']
3042,34765434,Role of nonsurgical periodontal therapy on leptin levels and total antioxidant capacity in chronic generalised periodontitis patients - A clinical trial.,"Introduction


Periodontitis causes oxidative stress and reduce total antioxidant levels. The aim of this study was to determine the effect of non-surgical periodontal treatment on leptin levels and total antioxidant capacity in chronic periodontitis.
Materials and methods


A total of 35 chronic periodontitis (ChP) patients and 35 systemically and periodontal healthy subjects were enrolled in this study. Further, the ChP group received nonsurgical periodontal therapy (NSPT). Leptin and total antioxidant capacity (TAOC) was measured in serum and saliva samples at baseline, 3 months and 6 months after non-surgical periodontal therapy. Clinical parameters measured were measured at baseline, 1, 3 and 6 months interval.
Results


The mean serum leptin and TAOC levels in control group were significantly higher compared to chronic periodontitis group (p < 0.05). The control group had lower mean salivary leptin levels and higher mean salivary TAOC levels as compared to periodontitis group(p < 0.05). Clinical parameters were improved in ChP group post therapy (p < 0.05). However, the periodontal treatment showed insignificant changes in serum and salivary leptin and TAOC levels.
Conclusion


Chronic periodontitis is significantly associated with serum and salivary TAOC and leptin levels. Non surgical periodontal therapy didn't alter the local and systemic TAOC and leptin levels.",2022,The mean serum leptin and TAOC levels in control group were significantly higher compared to chronic periodontitis group (p < 0.05).,"['chronic generalised periodontitis patients', 'chronic periodontitis', '35 chronic periodontitis (ChP) patients and 35 systemically and periodontal healthy subjects']","['nonsurgical periodontal therapy', 'nonsurgical periodontal therapy (NSPT']","['total antioxidant levels', 'leptin levels and total antioxidant capacity', 'mean serum leptin and TAOC levels', 'mean salivary leptin levels', 'serum and salivary TAOC and leptin levels', 'local and systemic TAOC and leptin levels', 'serum and salivary leptin and TAOC levels', 'mean salivary TAOC levels', 'Leptin and total antioxidant capacity (TAOC']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",35.0,0.0898135,The mean serum leptin and TAOC levels in control group were significantly higher compared to chronic periodontitis group (p < 0.05).,"[{'ForeName': 'Swet', 'Initials': 'S', 'LastName': 'Nisha', 'Affiliation': 'Dept of Periodontology, Haldia Institute of Dental Sciences & Research, Haldia, West Bengal, India.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Bettahalli Shivamallu', 'Affiliation': 'Dept. of Periodontology, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, Karnataka, India.'}, {'ForeName': 'Akila', 'Initials': 'A', 'LastName': 'Prashant', 'Affiliation': 'Dept. of Biochemistry, JSS Medical College, JSS Academy of Higher Education & Research, Mysuru, Karnataka, India.'}, {'ForeName': 'Manish Kumar', 'Initials': 'MK', 'LastName': 'Yadav', 'Affiliation': 'Wake Forest Institute of Regenerative Medicine, Wake Forest University, Winston Salem, NC, 27101, USA.'}, {'ForeName': 'Sheela Kumar', 'Initials': 'SK', 'LastName': 'Gujjari', 'Affiliation': 'Dept. of Periodontology, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, Karnataka, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Shashikumar', 'Affiliation': 'Dept. of Periodontology, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, Karnataka, India.'}]",Journal of oral biology and craniofacial research,['10.1016/j.jobcr.2021.10.002']
3043,34765784,Anodal tDCS effects over the left dorsolateral prefrontal cortex (L-DLPFC) on the rating of facial expression: evidence for a gender-specific effect.,"The accurate recognition of others' facial expressions is a core skill for social interactions. The left Dorsolateral Prefrontal Cortex (L-DLPFC) represents a key node in the network for facial emotion recognition. However, its specific role is still under debate. As such, the aim of the current neuromodulation study was to assess the causal role of the L-DLPFC in humans' rating of facial expressions of emotions and implicit attitudes toward other races. In this sham-controlled single-blind between-subject experiment, we offline administered L-DLPFC transcranial direct current stimulation (tDCS) to 69 healthy participants who were divided into three groups of 23 (each receiving anodal 1 mA tDCS, anodal 2 mA tDCS, or Sham), before completing an ""Emotion Rating task and two Implicit Association Tests (IATs). The former required the intensity rating of 192 faces (half black and half white) displaying happiness, sadness, anger, or fear. The IATs were designed to assess participants' automatic associations of positive or negative attributes with racial contents. Results on the Emotion Rating task showed participants' gender-specific effect of tDCS. Specifically, a  gender bias,  with only males showing a tendency to underestimate negative emotions was found in Sham, and absent in the tDCS groups. When considering the race of the stimuli, females but not males in Sham exhibited a  racial bias , that is, the tendency to overestimate negative emotions of other-race faces. Again, the bias disappeared in the tDCS groups. Concerning the IATs, no significant effects emerged. We conclude that the L-DLPFC plays a critical role in humans' rating of facial expressions, and for variability in other-race emotional judgements. These results shed light on the neural bases of the human emotional system and its gender-related differences, and have potential implications for interventional settings.",2021,"Concerning the IATs, no significant effects emerged.",['69 healthy participants who were divided into three groups of 23 (each receiving'],"['offline administered L-DLPFC transcranial direct current stimulation (tDCS', 'anodal 1 mA tDCS, anodal 2 mA tDCS, or Sham), before completing an ""Emotion Rating task and two Implicit Association Tests (IATs']","['Emotion Rating task', 'negative emotions', 'intensity rating of 192 faces (half black and half white) displaying happiness, sadness, anger, or fear']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",69.0,0.0444002,"Concerning the IATs, no significant effects emerged.","[{'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Palmisano', 'Affiliation': 'Department of Education, Psychology, and Communication, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bossi', 'Affiliation': 'IMT School for Advanced Studies Lucca, Lucca, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Barlabà', 'Affiliation': 'Department of Education, Psychology, and Communication, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Febbraio', 'Affiliation': 'Department of Education, Psychology, and Communication, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Loconte', 'Affiliation': 'Department of Education, Psychology, and Communication, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Lupo', 'Affiliation': 'Department of Education, Psychology, and Communication, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Center for Working Environment and Human Factors (IfADo), Dortmund, Germany.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Rivolta', 'Affiliation': 'Department of Education, Psychology, and Communication, University of Bari Aldo Moro, Bari, Italy.'}]",Heliyon,['10.1016/j.heliyon.2021.e08267']
3044,34765775,A Mixed-apprOach program To help women wIth breast cancer stay actiVE (MOTIVE program): A pilot-controlled study.,"Given the benefits of physical activity for breast cancer survivals, this pilot study aims to assess the feasibility of the MOTIVE program at achieving and maintaining the recommended physical activity level in women diagnosed and treated breast cancer, over 16 weeks. We conduct a pilot-controlled study of 20 women diagnosed with breast cancer stage I, II or IIIa. In this study, women of Intervention Arm (n = 10) received the MOTIVE program. This group was compared to women of Control Arm (n = 10) who received only counselling. Health-related fitness measures, and quality of life were assessed at baseline (t0) and after 4 (t1), 8 (t2) and 16 (t3) weeks. Intervention Arm women reached the recommended physical activity guidelines at t1 and t2 (eff.size = 1.9 [1.0-3.1]), and 90% continued to be active, autonomously, at t3 (eff.size = 1.12 [0.21-2.12]). Intervention Arm participants' arm strength, fitness levels and quality of life also improved over time. No significant improvements in outcome measures were observed in Control Arm participants. These results are encouraging and suggest that the MOTIVE program may be a viable, well tolerated and effective option to help breast cancer women reaching a stable physical activity level over time, which meets prevention-related goals.",2021,No significant improvements in outcome measures were observed in Control Arm participants.,"['women wIth breast cancer stay actiVE (MOTIVE program', 'women of Intervention Arm (n = 10', 'women diagnosed and treated breast cancer, over 16 weeks', '20 women diagnosed with breast cancer stage']",[],"['strength, fitness levels and quality of life also improved over time', 'physical activity guidelines', 'Health-related fitness measures, and quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.0166905,No significant improvements in outcome measures were observed in Control Arm participants.,"[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Natalucci', 'Affiliation': 'Department of Biomolecular Science, University of Urbino Carlo Bo, Via I. Maggetti, 26, 61029, Urbino, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Lucertini', 'Affiliation': 'Department of Biomolecular Science, University of Urbino Carlo Bo, Via I. Maggetti, 26, 61029, Urbino, Italy.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Vallorani', 'Affiliation': 'Department of Biomolecular Science, University of Urbino Carlo Bo, Via I. Maggetti, 26, 61029, Urbino, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Brandi', 'Affiliation': 'Department of Biomolecular Science, University of Urbino Carlo Bo, Via I. Maggetti, 26, 61029, Urbino, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Marchegiani', 'Affiliation': 'Neuro-rehabilitation Clinic, Breast Unit, Department of Neurological Science, University Hospital ""Ospedali Riuniti di Ancona"", Via Conca, 71, 60126, Ancona, Italy.'}, {'ForeName': 'Mirco', 'Initials': 'M', 'LastName': 'Pistelli', 'Affiliation': 'Oncology Clinic, Breast Unit, Department of Internal Medicine, University Hospital ""Ospedali Riuniti di Ancona"", Via Conca, 71, 60126, Ancona, Italy.'}, {'ForeName': 'Rossana', 'Initials': 'R', 'LastName': 'Berardi', 'Affiliation': 'Oncology Clinic, Breast Unit, Department of Internal Medicine, University Hospital ""Ospedali Riuniti di Ancona"", Via Conca, 71, 60126, Ancona, Italy.'}, {'ForeName': 'Maria Gabriella', 'Initials': 'MG', 'LastName': 'Ceravolo', 'Affiliation': 'Neuro-rehabilitation Clinic, Breast Unit, Department of Neurological Science, University Hospital ""Ospedali Riuniti di Ancona"", Via Conca, 71, 60126, Ancona, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barbieri', 'Affiliation': 'Department of Biomolecular Science, University of Urbino Carlo Bo, Via I. Maggetti, 26, 61029, Urbino, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Capecci', 'Affiliation': 'Neuro-rehabilitation Clinic, Breast Unit, Department of Neurological Science, University Hospital ""Ospedali Riuniti di Ancona"", Via Conca, 71, 60126, Ancona, Italy.'}]",Heliyon,['10.1016/j.heliyon.2021.e08252']
3045,34765720,Long-Term renal function after implantation of continuous-flow left ventricular assist devices: A single center study.,"Background


Implantable continuous-flow left ventricular assist device (LVAD) improve renal function in advanced heart failure. However, the long-term effects of LVAD on renal function have not been investigated thoroughly. We aimed to assess long-term renal function in patients with LVAD support and to identify predictors for late deterioration in renal function (LDRF).
Methods


One hundred patients underwent LVAD implantation as a bridge to transplant at the University of Tokyo Hospital between May 2011 and December 2018. We assessed renal function at intervals (preoperative, 1, 6, 12, 18, 24 and 30 months after LVAD implantation). We divided patients into two groups: ""with LDRF,"" whose renal function at 30 months had decreased by >25% compared with preoperatively (n = 14), and ""without LDRF"" (n = 55).
Results


Renal function improved at 1 month, returned to preoperative levels at 6 months, and remained there up to 30 months after LVAD implantation. However, renal function impairment became evident in patients with LDRF 18 months after LVAD implantation. A ratio of right atrial pressure/pulmonary artery wedge pressure > 0.57 and left ventricular dimension diastole ≤ 67 mm were preoperative independent risk factors for LDRF. In addition, the incidence of perioperative acute kidney injury, ventricular arrhythmia, aortic insufficiency, and late right ventricular failure was significantly higher in patients with LDRF.
Conclusion


LDRF after LVAD implantation corresponded to several risk factors, including a small left ventricle and LVAD-related complications, such as right ventricular failure.",2021,A ratio of right atrial pressure/pulmonary artery wedge pressure > 0.57 and left ventricular dimension diastole ≤ 67 mm were preoperative independent risk factors for LDRF.,"['patients with LDRF', 'advanced heart failure', 'One hundred patients underwent LVAD implantation as a bridge to transplant at the University of Tokyo Hospital between May 2011 and December 2018', 'patients with LVAD support and to identify predictors for late deterioration in renal function (LDRF']","['LVAD', 'without LDRF', 'continuous-flow left ventricular assist devices', '\n\n\nImplantable continuous-flow left ventricular assist device (LVAD']","['Renal function', 'perioperative acute kidney injury, ventricular arrhythmia, aortic insufficiency, and late right ventricular failure', 'renal function', 'renal function impairment', 'A ratio of right atrial pressure/pulmonary artery wedge pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0235527', 'cui_str': 'Right heart failure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456165', 'cui_str': 'Right atrial pressure'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}]",100.0,0.0310922,A ratio of right atrial pressure/pulmonary artery wedge pressure > 0.57 and left ventricular dimension diastole ≤ 67 mm were preoperative independent risk factors for LDRF.,"[{'ForeName': 'Chie', 'Initials': 'C', 'LastName': 'Bujo', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Amiya', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Hatano', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Ishida', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Tsuji', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Kakuda', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Narita', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yagi', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Shimada', 'Affiliation': 'Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Mitsutoshi', 'Initials': 'M', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Komuro', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan.'}]",International journal of cardiology. Heart & vasculature,['10.1016/j.ijcha.2021.100907']
3046,34765697,"How and Why Consumers View ""Little Cigars"" as Legally-Defined Cigarettes.","Objective


To test if consumers perceive filtered ""little cigars"" as legally-defined cigarettes and identify features they associate with cigarettes but not little cigars and vice versa.
Methods


1,030 adults ( mean  age 31.1 years, 34% male, 25% non-white) were randomized in a 2×2 between-subjects experiment to view images of filtered ""little cigars"" that varied by package labeling (cigars: yes/no) and the product displayed in front of the packaging (filtered ""little cigar"" or cigarette). Measures assessed participants' perceptions that the product shown can be used as a substitute for cigarettes and features perceived to be associated with cigarettes vs. little cigars.
Results


Participants perceived filtered ""little cigars"" as substitutes for cigarettes, perceived certain features to be more like little cigars (e.g., no filter/tip, wrapped in tobacco leaf) and others to be more like cigarettes (e.g., filtered, could be inhaled deeply). In analysis of covariance assessing experimental condition effects, participants viewing images of cigarettes had stronger perceptions that filtered ""little cigars"" could be used as cigarette substitutes and had cigarette characteristics, but the effect was small.
Conclusions


This study provides new evidence that filtered ""little cigars"" are perceived by consumers as cigarettes under current laws and identifies features distinguishing little cigars from cigarettes.",2019,"In analysis of covariance assessing experimental condition effects, participants viewing images of cigarettes had stronger perceptions that filtered ""little cigars"" could be used as cigarette substitutes and had cigarette characteristics, but the effect was small.
","['1,030 adults ( mean  age 31.1 years, 34% male, 25% non-white']","['filtered ""little cigars"" that varied by package labeling (cigars: yes/no) and the product displayed in front of the packaging (filtered ""little cigar"" or cigarette']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0678446', 'cui_str': 'Cigar'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",[],1030.0,0.0739001,"In analysis of covariance assessing experimental condition effects, participants viewing images of cigarettes had stronger perceptions that filtered ""little cigars"" could be used as cigarette substitutes and had cigarette characteristics, but the effect was small.
","[{'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Lindblom', 'Affiliation': ""Eric N. Lindblom, Program Director, O'Neill Institute for National & Global Health Law, Georgetown University Law Center, Washington, DC. Andrea C. Johnson, Doctoral Student, Milken Institute School of Public Health, George Washington University, Washington, DC. Tiffany Gray, Doctoral Student, Milken Institute School of Public Health, George Washington University, Washington, DC. George Luta, Associate Professor, Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, Washington, DC. Darren Mays, Associate Professor, Cancer Prevention & Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.""}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Johnson', 'Affiliation': ""Eric N. Lindblom, Program Director, O'Neill Institute for National & Global Health Law, Georgetown University Law Center, Washington, DC. Andrea C. Johnson, Doctoral Student, Milken Institute School of Public Health, George Washington University, Washington, DC. Tiffany Gray, Doctoral Student, Milken Institute School of Public Health, George Washington University, Washington, DC. George Luta, Associate Professor, Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, Washington, DC. Darren Mays, Associate Professor, Cancer Prevention & Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.""}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Gray', 'Affiliation': ""Eric N. Lindblom, Program Director, O'Neill Institute for National & Global Health Law, Georgetown University Law Center, Washington, DC. Andrea C. Johnson, Doctoral Student, Milken Institute School of Public Health, George Washington University, Washington, DC. Tiffany Gray, Doctoral Student, Milken Institute School of Public Health, George Washington University, Washington, DC. George Luta, Associate Professor, Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, Washington, DC. Darren Mays, Associate Professor, Cancer Prevention & Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Luta', 'Affiliation': ""Eric N. Lindblom, Program Director, O'Neill Institute for National & Global Health Law, Georgetown University Law Center, Washington, DC. Andrea C. Johnson, Doctoral Student, Milken Institute School of Public Health, George Washington University, Washington, DC. Tiffany Gray, Doctoral Student, Milken Institute School of Public Health, George Washington University, Washington, DC. George Luta, Associate Professor, Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, Washington, DC. Darren Mays, Associate Professor, Cancer Prevention & Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.""}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': ""Eric N. Lindblom, Program Director, O'Neill Institute for National & Global Health Law, Georgetown University Law Center, Washington, DC. Andrea C. Johnson, Doctoral Student, Milken Institute School of Public Health, George Washington University, Washington, DC. Tiffany Gray, Doctoral Student, Milken Institute School of Public Health, George Washington University, Washington, DC. George Luta, Associate Professor, Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, Washington, DC. Darren Mays, Associate Professor, Cancer Prevention & Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.""}]",Tobacco regulatory science,['10.18001/trs.5.2.4']
3047,34765674,Driving with hemianopia VIII: Effects of a vibro-tactile assistance system on safety and gaze behavior in pedestrian crossing situations.,"People with homonymous visual field defects (HVFDs), the loss of vision in the same half of the visual field in both eyes, are permitted to drive in some jurisdictions. However, the HVFD may cause difficulties in detecting hazards approaching on the side of the field loss (the blind side). An advanced driver assistance system (ADAS) could assist with hazard detection, but little research has been conducted to evaluate the potential benefits of an ADAS for visually impaired drivers. We developed a prototype vibro-tactile assistance system for drivers with HVFDs and conducted a proof-of-concept driving simulation study to evaluate the system. Given that pedestrian accidents are the second most frequent cause of death in road traffic and most of those accidents occur in urban scenarios, we evaluated the potential of the assistance system to improve responses to pedestrian hazards in a city environment. Sixteen participants, of which eight had HVFDs and eight had normal vision, took part. Our analyses evaluated the effects of the driver assistance system, crossing direction and pedestrian behavior on the safety of pedestrian events and the participant's gaze behavior at each of the 256 crossing situations. Generalized linear mixed effects models were used to assess binomial outcome variables. Despite the limited sample size, the results suggest that the vibro-tactile directional warnings were effective in directing the drivers' gaze so that they were looking in the necessary direction before a potential hazard occurred. More time was spent fixating pedestrians on the blind side when the ADAS was engaged and as a result, the safety of street crossings from the blind side improved. The effect of the ADAS was greater on responses to pedestrians from the blind than the seeing side. With an activated ADAS, crossings from the participants' blind sides were as safe as from their seeing sides, and as safe as the crossings when normally-sighted participants were driving. The results suggest that the vibro-tactile ADAS is a promising approach to improve the safety of drivers with HVFD and surrounding traffic.",2021,The results suggest that the vibro-tactile ADAS is a promising approach to improve the safety of drivers with HVFD and surrounding traffic.,"['pedestrian crossing situations', 'People with homonymous visual field defects (HVFDs', 'drivers with HVFDs', 'Sixteen participants, of which eight had HVFDs and eight had normal vision, took part']","['ADAS', 'vibro-tactile assistance system', 'prototype vibro-tactile assistance system']",['safety and gaze behavior'],"[{'cui': 'C0450063', 'cui_str': 'Pedestrian'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3887875', 'cui_str': 'Visual field defect'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0686183,The results suggest that the vibro-tactile ADAS is a promising approach to improve the safety of drivers with HVFD and surrounding traffic.,"[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hölzl', 'Affiliation': 'Technical University of Munich.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Steckhan', 'Affiliation': 'Technical University of Munich.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lehsing', 'Affiliation': 'Technical University of Munich.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Savage', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Bowers', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School.'}]","Safety (Basel, Switzerland)",['10.3390/safety7010018']
3048,34765950,"Monosialotetrahexosylganglioside in the treatment of chronic oxaliplatin-induced peripheral neurotoxicity: TJMUCH-GI-001, a randomised controlled trial.","Background


Chronic oxaliplatin-induced peripheral neurotoxicity (OIPN) is the most troublesome and dose-limiting side effect of oxaliplatin. There is no effective treatment for chronic OIPN. We conducted a randomised controlled trial to investigate the efficacy of monosialotetrahexosylganglioside (GM1) in treating chronic OIPN.
Methods


In this single-centre, double-blind, phase Ⅲ trial, gastrointestinal cancer patients with persistent chronic OIPN were randomised in 1:1 ratio to receive either GM1 or placebo at Tianjin Medical University Cancer Institute and Hospital, China. GM1 was dosed at 60 mg daily for every 3 weeks or 40 mg daily for every 2 weeks. Seven- and fourteen- day infusions were administered to concurrent oxaliplatin users and oxaliplatin discontinuation patients, respectively. The primary endpoint was the relief of neurotoxicity (≥30% improvement), measured by a newly developed patient reported outcome measure (MCIPN) based on prior questionnaires including the European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy Induced Peripheral Neuropathy Questionnaire twenty-item scale. Visual analogue score (VAS) was used as another instrument for patients to evaluate the total Chronic OIPN treatment effect. VAS responders (≥30% improvement), double responders (≥30% improvement in both MCIPN and VAS), and high responders (≥50% improvement in the MCIPN total score) were also calculated. The secondary endpoints were safety and quality of life. The additional endpoints are progression-free survival (PFS), disease-free survival (DFS), overall survival (OS), and tumour response. (Trial registration number: NCT02486198 at ClinicalTrials.gov).
Findings


Between May 2015 to December 2017, 145 patients were randomly assigned to receive either GM1 (n=73) and placebo (n=72). Majority of the patients in both arms (90% in GM1 and 83% in placebo) continued receiving oxaliplatin on the trial. More patients responded in the GM1 group than in the placebo group (MCIPN responders: 53% vs 14%, VAS responders: 49% vs 22%, double responders: 41% vs 7%, and high responders: 32% vs 13%, all  P  < ·01). Analyses were also performed in concurrent oxaliplatin users. The results were consistent with those of the whole group. No deleterious effects of GM1 on survival or tumour response were found. There were no ≥G3 GM1-related adverse events.
Interpretation


In patients with chronic OIPN, the use of GM1 reduces the severity of chronic OIPN compared with placebo.
Funding


This work was supported by clinical trial development fund of Tianjin Medical University Cancer Institute and Hospital (No.C1706).",2021,"More patients responded in the GM1 group than in the placebo group (MCIPN responders: 53% vs 14%, VAS responders: 49% vs 22%, double responders: 41% vs 7%, and high responders: 32% vs 13%, all  P  < ·01).","['chronic oxaliplatin-induced peripheral neurotoxicity: TJMUCH-GI-001', 'patients with chronic OIPN', 'at Tianjin Medical University Cancer Institute and Hospital, China', 'gastrointestinal cancer patients with persistent chronic OIPN', 'Tianjin Medical University Cancer Institute and Hospital ', 'Findings\n\n\nBetween May 2015 to December 2017', '145 patients']","['GM1', 'GM1 or placebo', 'oxaliplatin users and oxaliplatin', 'Monosialotetrahexosylganglioside', '\n\n\nChronic oxaliplatin-induced peripheral neurotoxicity (OIPN', 'placebo', 'oxaliplatin', 'monosialotetrahexosylganglioside (GM1']","['survival or tumour response', 'Visual analogue score (VAS', 'outcome measure (MCIPN) based on prior questionnaires including the European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy Induced Peripheral Neuropathy Questionnaire twenty-item scale', 'relief of neurotoxicity', 'safety and quality of life', 'VAS responders', 'progression-free survival (PFS), disease-free survival (DFS), overall survival (OS), and tumour response', 'severity of chronic OIPN']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C0016895', 'cui_str': 'Ganglioside GM>1<'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}]",145.0,0.411598,"More patients responded in the GM1 group than in the placebo group (MCIPN responders: 53% vs 14%, VAS responders: 49% vs 22%, double responders: 41% vs 7%, and high responders: 32% vs 13%, all  P  < ·01).","[{'ForeName': 'Likun', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Dingzhi', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Ning', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Ge', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Bai', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Yuchong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'XinYi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Xingyun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Medical Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Laizhi', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Guangzhou Medical University, Guangzhou Chest Hospital, Guangzhou, China.'}, {'ForeName': 'Yuanquan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Division of medical oncology, the Ohio state university, Columbus, Ohio.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Deng', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ba', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy Tianjin Medical University, Tianjin, China.""}]",EClinicalMedicine,['10.1016/j.eclinm.2021.101157']
3049,34765938,A randomized prospective study to assess health-related quality-of-life outcomes of antiretroviral therapy in human immunodeficiency virus-positive adults.,"Introduction


Health-related quality of life (HRQOL) in human immunodeficiency virus (HIV)-positive individuals is substantially challenged due to disease, opportunistic infections, lifelong commitment, and tolerability to antiretroviral therapy (ART) and various social, physical, and psychological domains.
Aim


This study was conducted to assess the magnitude of the impact on HRQOL in HIV-positive people from early access to ART.
Settings and Design


This was a randomized, prospective, open-label study, conducted at the ART center attached to the Government Medical College, Amritsar.
Subjects and Methods


This study comprised 240 HIV-infected adults in the age group >18 years who presented to the ART center. Approval from the Institutional Ethics Committee was obtained. Informed consent was taken from all the enrolled participants after explaining the study therapy and its benefits and side effects. Patients who presented early in their course of disease and had baseline CD4 count ≥350/mm 3  were recruited in early arm and those with <350/mm 3  or the development of symptomatic HIV-related disease in the late arm. Following stratification, both groups were 1:1 randomized by permuted block randomization. The primary objective was to assess HRQOL using the World Health Organization Quality of Life-HIV brief instrument (WHOQOL-HIV).
Statistical Analysis Used


The summary domain and total HRQOL scores were calculated using method developed by the WHOQOL-HIV group. Unpaired  t -test was applied for statistical analysis, with level of significance expressed as  P  < 0.05.
Results


Out of the total 240 HIV-positive patients, 120 who met eligibility criteria were recruited for the final analysis. There was a significant difference between HRQOL score of Physical domains and Psychological domains, between early and late arms at baseline and at the end of 9 months.
Conclusions


Quality of life is an important holistic measure for assessing the health of people living with HIV/AIDS.",2021,"There was a significant difference between HRQOL score of Physical domains and Psychological domains, between early and late arms at baseline and at the end of 9 months.
","['human immunodeficiency virus-positive adults', 'human immunodeficiency virus (HIV)-positive individuals', 'Patients who presented early in their course of disease and had baseline CD4 count ≥350/mm 3  were recruited in early arm and those with <350/mm 3  or the development of symptomatic HIV-related disease in the late arm', '240 HIV-positive patients, 120 who met eligibility criteria were recruited for the final analysis', 'Subjects and Methods', '240 HIV-infected adults in the age group >18 years who presented to the ART center', 'HIV-positive people from early access to ART']",['antiretroviral therapy'],"['quality of life (HRQOL', 'summary domain and total HRQOL scores', 'HRQOL using the World Health Organization Quality of Life-HIV brief instrument (WHOQOL-HIV', 'HRQOL score of Physical domains and Psychological domains']","[{'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",240.0,0.111942,"There was a significant difference between HRQOL score of Physical domains and Psychological domains, between early and late arms at baseline and at the end of 9 months.
","[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Jatinder', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Department of Pharmacology, Government Medical College, Amritsar, Punjab, India.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Department of Medicine, Government Medical College, Amritsar, Punjab, India.'}]",Indian journal of sexually transmitted diseases and AIDS,['10.4103/ijstd.IJSTD_102_19']
3050,34766389,Effect of Melissa officinalis on systolic and diastolic blood pressures in essential hypertension: A double-blind crossover clinical trial.,"For a long time, Melissa officinalis (M. officinalis) has been used to treat cardiovascular diseases. Therefore, this study aimed at evaluating the effects of M. officinalis on systolic and diastolic blood pressures in hypertensive patients. We conducted a double-blind, controlled, randomized crossover clinical trial on 49 patients who received either M. officinalis capsules (400 mg/d; n = 23) or the placebo (n = 26) three times per day for a 4-week period. After a 2-week washout period, the M. officinalis group received placebo and the other group received M. officinalis for another 4-week period. The systolic and diastolic blood pressures were measured once at baseline and then every 2 weeks for 10 weeks. The statistical analysis of the obtained data revealed that the chronology of the consumption of M. officinalis and placebo had no effect on the systolic and diastolic blood pressures in these two studied groups. Moreover, it was found that systolic and diastolic blood pressures significantly decreased after the consumption of M. officinalis, compared to placebo. Systolic and diastolic blood pressures in group A at the beginning of the study were 152.30 ± 5.312 mmHg and 95.52 ± 1.988 mmHg, respectively, and, after the first phase (drug use), reached 129.88 ± 9.009 mmHg and 80.13 ± 5.488 mmHg, respectively. Systolic and diastolic blood pressures in group B at the beginning of the study was 152.26 ± 5.640 mmHg and 94.44 ± 2.607 mmHg, respectively, and after the second phase (drug use), reached 131.77 ± 8.091 mmHg and 81.46 ± 7.426 mmHg, (p = .005), respectively. Also, no significant side effects were observed during the study. According to the results, M. officinalis can reduce systolic and diastolic blood pressures of the patients with essential hypertension.",2021,"According to the results, M. officinalis can reduce systolic and diastolic blood pressures of the patients with essential hypertension.","['essential hypertension', 'hypertensive patients', '49 patients who received either', 'patients with essential hypertension']","['M. officinalis capsules (400\u2009mg/d; n\xa0=\u200923) or the placebo', 'placebo', 'M. officinalis', 'Melissa officinalis']","['Systolic and diastolic blood pressures', 'systolic and diastolic blood pressures', 'side effects']","[{'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1008143', 'cui_str': 'Lemon Balm'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",49.0,0.126074,"According to the results, M. officinalis can reduce systolic and diastolic blood pressures of the patients with essential hypertension.","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Shekarriz', 'Affiliation': 'Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Seyed Afshin', 'Initials': 'SA', 'LastName': 'Shorofi', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing and Midwifery, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nabati', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Bizhan', 'Initials': 'B', 'LastName': 'Shabankhani', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Seyde Sedighe', 'Initials': 'SS', 'LastName': 'Yousefi', 'Affiliation': 'Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.7251']
3051,34766245,Political Orientation as Psychological Defense or Basic Disposition? A Social Neuroscience Examination.,"Psychological views on political orientation generally agree that conservatism is associated with negativity bias but disagree on the form of that association. Some view conservatism as a psychological defense that insulates from negative stimuli and events. Others view conservatism as a consequence of increased dispositional sensitivity to negative stimuli and events. Further complicating matters, research shows that conservatives are sometimes more and sometimes less sensitive to negative stimuli and events. The current research integrates these opposing views and results. We reasoned that conservatives should typically be less sensitive to negative stimuli if conservative beliefs act as a psychological defense. However, when core components of conservative beliefs are threatened, the psychological defense may fall, and conservatives may show heightened sensitivity to negative stimuli. In two ERP studies, participants were randomly assigned to either an ostensibly real economic threat or a nonthreatening control condition. To measure reactivity to negative stimuli, we indexed the P3 component to aversive white noise bursts in an auditory oddball paradigm. In both studies, the relationship between increased conservatism and P3 mean amplitude was negative in the control condition but positive in threat condition (this relationship was stronger in Study 2). In Study 2, source localization of the P3 component revealed that, after threat, conservatism was associated with increased activity in the anterior cingulate cortex and dorsomedial prefrontal cortex, regions associated with conflict-related processes. These results demonstrate that the link between conservatism and negativity bias is context-dependent, i.e., dependent on threat experiences.",2021,"In both studies, the relationship between increased conservatism and P3 mean amplitude was negative in the control condition but positive in threat condition (this relationship was stronger in Study 2).",[],"['P3 component to aversive white noise bursts in an auditory oddball paradigm', 'ostensibly real economic threat or a nonthreatening control condition']",['conservatism and P3 mean amplitude'],[],"[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0009800', 'cui_str': 'Conservatism'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0273459,"In both studies, the relationship between increased conservatism and P3 mean amplitude was negative in the control condition but positive in threat condition (this relationship was stronger in Study 2).","[{'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Nash', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, AB, Canada. knash@ualberta.ca.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Leota', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, AB, Canada.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-021-00965-y']
3052,34768692,Effect of Biofeedback Therapy during Temporary Stoma Period in Rectal Cancer Patients: A Prospective Randomized Trial.,"BACKGROUND


This prospective randomized controlled study was designed to evaluate the effect of biofeedback therapy (BFT) during temporary stoma period to prevent defecation dysfunction after sphincter-preserving surgery (SPS).
METHODS


Following SPS with temporary stoma, patients were divided according to whether (BFT group) or not (Control group) they received BFT. BFT was performed once or twice a week during the temporary stoma period. Kegel exercise were advised to all the patients. Subjective defecation symptoms were evaluated according to Cleveland Clinic Incontinence Score (CCIS) as primary outcome at 12 months postoperatively. Manometric data of five time-points were also analyzed.
RESULTS


Twenty-one patients in the BFT group and 23 patients in the control group received anorectal physiologic testing. The incidence of CCIS of more than 9 points, which is the primary end point in this study, was not statistically different between BFT group and control group ( p  = 1.000). The liquid stool incontinence in the BFT group showed a better tendency ( p  = 0.06) at 12 months post-SPS. Time-dependent serial changes in maximal sensory threshold (Max RST) was significantly different between the BFT and control groups ( p  = 0.048). Also, the change of mean resting pressure (MRP) tended to be more stable in the BFT group ( p  = 0.074).
CONCLUSIONS


The BFT in the period of temporary stoma may be related to liquid stool incontinence at 12 months post-SPS and lead to stable MRP and better Max RST. Therefore, BFT during temporary stoma might be helpful for preventing and minimizing defecation dysfunction in high risk patients after SPS, NCT01661829).",2021,Time-dependent serial changes in maximal sensory threshold (Max RST) was significantly different between the BFT and control groups ( p  = 0.048).,"['Rectal Cancer Patients', 'defecation dysfunction after sphincter-preserving surgery (SPS']","['Kegel exercise', 'BFT', 'Biofeedback Therapy', 'biofeedback therapy (BFT']","['Subjective defecation symptoms', 'incidence of CCIS', 'liquid stool incontinence', 'Cleveland Clinic Incontinence Score (CCIS', 'anorectal physiologic testing', 'Time-dependent serial changes in maximal sensory threshold (Max RST', 'mean resting pressure (MRP']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0262718', 'cui_str': 'Pelvic floor exercises'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2129214', 'cui_str': 'Loose stool'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0036677', 'cui_str': 'Sensory threshold'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0035934', 'cui_str': 'Rubinstein-Taybi syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0290741', 'cui_str': 'Multidrug Resistance-Associated Protein'}]",,0.017638,Time-dependent serial changes in maximal sensory threshold (Max RST) was significantly different between the BFT and control groups ( p  = 0.048).,"[{'ForeName': 'Hyeon-Min', 'Initials': 'HM', 'LastName': 'Cho', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon 16247, Korea.""}, {'ForeName': 'Hyungjin', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.""}, {'ForeName': 'RiNa', 'Initials': 'R', 'LastName': 'Yoo', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon 16247, Korea.""}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon 16247, Korea.""}, {'ForeName': 'Bong-Hyeon', 'Initials': 'BH', 'LastName': 'Kye', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon 16247, Korea.""}]",Journal of clinical medicine,['10.3390/jcm10215172']
3053,34768949,Management and Medical Therapy of Mild Hypercortisolism.,"Mild hypercortisolism (mHC) is defined as an excessive cortisol secretion, without the classical manifestations of clinically overt Cushing's syndrome. This condition increases the risk of bone fragility, neuropsychological alterations, hypertension, diabetes, cardiovascular events and mortality. At variance with Cushing's syndrome, mHC is not rare, with it estimated to be present in up to 2% of individuals older than 60 years, with higher prevalence (up to 10%) in individuals with uncontrolled hypertension and/or diabetes or with unexplainable bone fragility. Measuring cortisol after a 1 mg overnight dexamethasone suppression test is the first-line test for searching for mHC, and the degree of cortisol suppression is associated with the presence of cortisol-related consequences and mortality. Among the additional tests used for diagnosing mHC in doubtful cases, the basal morning plasma adrenocorticotroph hormone, 24-h urinary free cortisol and/or late-night salivary cortisol could be measured, particularly in patients with possible cortisol-related complications, such as hypertension and diabetes. Surgery is considered as a possible therapeutic option in patients with munilateral adrenal incidentalomas and mHC since it improves diabetes and hypertension and reduces the fracture risk. In patients with mHC and bilateral adrenal adenomas, in whom surgery would lead to persistent hypocortisolism, and in patients refusing surgery or in whom surgery is not feasible, medical therapy is needed. Currently, promising though scarce data have been provided on the possible use of pituitary-directed agents, such as the multi-ligand somatostatin analog pasireotide or the dopamine agonist cabergoline for the-nowadays-rare patients with pituitary mHC. In the more frequently adrenal mHC, encouraging data are available for metyrapone, a steroidogenesis inhibitor acting mainly against the adrenal 11-βhydroxylase, while data on osilodrostat and levoketoconazole, other new steroidogenesis inhibitors, are still needed in patients with mHC. Finally, on the basis of promising data with mifepristone, a non-selective glucocorticoid receptor antagonist, in patients with mild cortisol hypersecretion, a randomized placebo-controlled study is ongoing for assessing the efficacy and safety of relacorilant, a selective glucocorticoid receptor antagonist, for patients with mild adrenal hypercortisolism and diabetes mellitus/impaired glucose tolerance and/or uncontrolled systolic hypertension.",2021,"Mild hypercortisolism (mHC) is defined as an excessive cortisol secretion, without the classical manifestations of clinically overt Cushing's syndrome.","['patients with mild cortisol hypersecretion', 'patients with mild adrenal hypercortisolism and diabetes mellitus/impaired glucose tolerance and/or uncontrolled systolic hypertension', 'patients with munilateral adrenal incidentalomas', 'patients with mHC', 'patients with mHC and bilateral adrenal adenomas', 'individuals older than 60 years, with higher prevalence (up to 10%) in individuals with uncontrolled hypertension and/or diabetes or with unexplainable bone fragility']","['mifepristone', 'placebo', 'dopamine agonist cabergoline']","['basal morning plasma adrenocorticotroph hormone, 24-h urinary free cortisol and/or late-night salivary cortisol', 'risk of bone fragility, neuropsychological alterations, hypertension, diabetes, cardiovascular events and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0001622', 'cui_str': 'Hypercortisolism'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0221155', 'cui_str': 'Systolic hypertension'}, {'cui': 'C2609247', 'cui_str': 'Adrenal incidentaloma'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0206667', 'cui_str': 'Adrenal cortical adenoma'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0107994', 'cui_str': 'cabergoline'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0449161,"Mild hypercortisolism (mHC) is defined as an excessive cortisol secretion, without the classical manifestations of clinically overt Cushing's syndrome.","[{'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Favero', 'Affiliation': 'Department of Medical Biotechnology and Translational Medicine, University of Milan, 20133 Milan, Italy.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Cremaschi', 'Affiliation': 'Department of Medical Biotechnology and Translational Medicine, University of Milan, 20133 Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Falchetti', 'Affiliation': 'Department of Endocrine and Metabolic Diseases, IRCCS, Istituto Auxologico Italiano, 20149 Milan, Italy.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Gaudio', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, 95123 Catania, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Gennari', 'Affiliation': 'Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Scillitani', 'Affiliation': 'Unit of Endocrinology and Diabetology ""Casa Sollievo della Sofferenza"" Hospital, IRCCS, 71013 San Giovanni Rotondo (FG), Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Vescini', 'Affiliation': 'Endocrinology and Metabolism Unit, University-Hospital S. M. Misericordia of Udine, 33100 Udine, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Morelli', 'Affiliation': 'Unit of Endocrinology, Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico, 20122 Milan, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Aresta', 'Affiliation': 'Department of Endocrine and Metabolic Diseases, IRCCS, Istituto Auxologico Italiano, 20149 Milan, Italy.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Chiodini', 'Affiliation': 'Department of Medical Biotechnology and Translational Medicine, University of Milan, 20133 Milan, Italy.'}]",International journal of molecular sciences,['10.3390/ijms222111521']
3054,34769658,Development and Pilot Testing of a Smartphone-Based Self-Care Program for Patients with Chronic Hepatitis B.,"The purpose of this study is to develop a smartphone-based self-care program (Hep B Care ® ) for patients with the chronic hepatitis B virus (HBV). To pilot test the feasibility of Hep B Care ® , 63 participants with chronic HBV were recruited from an outpatient clinic at S hospital, Seoul, South Korea (experimental group [EG]:  n  = 30, control group [CG]:  n  = 33) between February and July 2016. Hep B Care ®  was developed based on the theory of self-care whilst having a chronic illness. During the 12-week intervention period, the application: (1) provided information about the disease, medication, nutrition, and exercise; (2) encouraged taking medication and exercise using alarms; and (3) enabled the exchange of messages between healthcare providers and patients. Salivary cortisol, fatigue, depression, anxiety, knowledge of the HBV, quality of life, and medication adherence were all measured as outcomes. Cortisol levels were significantly increased, knowledge of the HBV was improved, and the mean anxiety score was significantly decreased in the EG. Thus, Hep B Care  ®  partially improved health outcomes in the EG. We recommend that large trials be conducted among patients with the HBV. The smartphone-based self-care program for providing education and coaching is effective for improving knowledge and reducing anxiety among patients with the HBV.",2021,"Salivary cortisol, fatigue, depression, anxiety, knowledge of the HBV, quality of life, and medication adherence were all measured as outcomes.","['patients with the chronic hepatitis B virus (HBV', 'patients with the HBV', '63 participants with chronic HBV were recruited from an outpatient clinic at S hospital, Seoul, South Korea (experimental group [EG]:  n  = 30, control group [CG]:  n  = 33) between February and July 2016', 'Patients with Chronic Hepatitis B']","['Smartphone-Based Self-Care Program', 'Hep B Care ®', 'smartphone-based self-care program (Hep B Care ® ', 'application: (1) provided information about the disease, medication, nutrition, and exercise; (2) encouraged taking medication and exercise using alarms; and (3) enabled the exchange of messages between healthcare providers and patients']","['mean anxiety score', 'Cortisol levels', 'Salivary cortisol, fatigue, depression, anxiety, knowledge of the HBV, quality of life, and medication adherence', 'knowledge of the HBV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",63.0,0.0094056,"Salivary cortisol, fatigue, depression, anxiety, knowledge of the HBV, quality of life, and medication adherence were all measured as outcomes.","[{'ForeName': 'Yeonsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University, 50-1, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'College of Medicine, Department of Internal Medicine, Institute of Gastroenterology, Yonsei University, 50-1, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Kyunghwa', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Konyang University, Daejeon 35365, Korea.'}, {'ForeName': 'Oh Young', 'Initials': 'OY', 'LastName': 'Kwon', 'Affiliation': 'College of Nursing and Brain Korea 21 FOUR Project, Yonsei University, 50-1, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Jeong Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Ansan University, Ansan 15328, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph182111139']
3055,34769656,"Impact of a Brief Family Skills Training Programme (""Strong Families"") on Parenting Skills, Child Psychosocial Functioning, and Resilience in Iran: A Multisite Controlled Trial.","Caregivers have a key role in protecting children's wellbeing, and, with appropriate skills, can prevent a multitude of negative social outcomes, particularly in challenged or humanitarian settings. Accordingly, the Strong Families programme was designed as a light touch family skills programme, with a focus of supporting caregiving during stressful situations. To evaluate the short-term impact of the Strong Families programme, we performed a time-convenience, randomized, controlled trial in Iran. A total of 292 families (63% from Iranian decent, 39% from Afghan decent, and 1% other), with children aged eight to twelve years, were recruited through ten centers in Iran and allocated to an intervention ( n  = 199) or waitlist/control group ( n  = 93). The two groups did not differ demographically at baseline. We assessed families prospectively, through three scales, PAFAS (parenting and family adjustment scales), SDQ (strengths and difficulties questionnaire), and CYRM-R (child and youth resilience measure). Caregivers in the intervention group improved (highly) statistically significantly on all but one PAFAS subscales (parental consistency, coercive parenting, positive encouragement, parental adjustment, family relationships, and parental teamwork), which was not noted in the waitlist group. On the SDQ, there were (highly) significant positive changes in scores in the intervention group on all sub-scales and the ""total difficulty scale"", whereas the waitlist/control group also improved on three (prosocial, conduct problems, and hyperactivity) of the five SDQ subscales. Children originating from Afghanistan improved significantly on the overall resilience scale of the CYRM-R in the intervention group, but not in the waitlist/control group. Overall, all our stratified results of the different scales reflect an accentuated improvement in families with higher levels of problems at baseline. Our comparative results indicated a strong alignment of the strong families programme with its intended short-term impact, per its logical frame on parenting practices and family management skills, children behaviour, caregivers and children mental health, and capacity to cope with stress. We postulate that the potential nudging or diffusion of knowledge (cross-contamination between intervention and waitlist/control group) at the community level could explain improvements in the waitlist/control group on some indicators, however, further research on this is recommend.",2021,"Children originating from Afghanistan improved significantly on the overall resilience scale of the CYRM-R in the intervention group, but not in the waitlist/control group.","['in Iran', '292 families (63% from Iranian decent, 39% from Afghan decent, and 1% other), with children aged eight to twelve years, were recruited through ten centers in Iran and allocated to an intervention ( n  = 199) or waitlist/control group ( n  = 93', 'Iran']","['Brief Family Skills Training Programme (""Strong Families']","['three (prosocial, conduct problems, and hyperactivity', 'Parenting Skills, Child Psychosocial Functioning, and Resilience', 'PAFAS (parenting and family adjustment scales), SDQ (strengths and difficulties questionnaire), and CYRM-R (child and youth resilience measure', 'overall resilience scale of the CYRM-R', 'PAFAS subscales (parental consistency, coercive parenting, positive encouragement, parental adjustment, family relationships, and parental teamwork']","[{'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}]",292.0,0.034945,"Children originating from Afghanistan improved significantly on the overall resilience scale of the CYRM-R in the intervention group, but not in the waitlist/control group.","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Haar', 'Affiliation': 'Prevention, Treatment and Rehabilitation Section, Drug Prevention and Health Branch, Division of Operations, United Nations Office on Drugs and Crime (UNODC), Wagramer Strasse 5, A-1400 Vienna, Austria.'}, {'ForeName': 'Aala', 'Initials': 'A', 'LastName': 'El-Khani', 'Affiliation': 'Prevention, Treatment and Rehabilitation Section, Drug Prevention and Health Branch, Division of Operations, United Nations Office on Drugs and Crime (UNODC), Wagramer Strasse 5, A-1400 Vienna, Austria.'}, {'ForeName': 'Gelareh', 'Initials': 'G', 'LastName': 'Mostashari', 'Affiliation': 'United Nations Office on Drugs and Crime, Field Office I.R. of Iran, P.O. Box 15875-4557, Tehran 1994715311, Iran.'}, {'ForeName': 'Mahdokht', 'Initials': 'M', 'LastName': 'Hafezi', 'Affiliation': 'United Nations Office on Drugs and Crime, Field Office I.R. of Iran, P.O. Box 15875-4557, Tehran 1994715311, Iran.'}, {'ForeName': 'Atoosa', 'Initials': 'A', 'LastName': 'Malek', 'Affiliation': 'United Nations Office on Drugs and Crime, Field Office I.R. of Iran, P.O. Box 15875-4557, Tehran 1994715311, Iran.'}, {'ForeName': 'Wadih', 'Initials': 'W', 'LastName': 'Maalouf', 'Affiliation': 'Prevention, Treatment and Rehabilitation Section, Drug Prevention and Health Branch, Division of Operations, United Nations Office on Drugs and Crime (UNODC), Wagramer Strasse 5, A-1400 Vienna, Austria.'}]",International journal of environmental research and public health,['10.3390/ijerph182111137']
3056,34769642,Posters as a Tool to Improve Hand Hygiene among Health Science Students: Case-Control Study.,"(1) Background: Numerous educational interventions have been conducted to improve hand hygiene (HH) compliance and effectiveness among nursing students, with mixed results. The aim is to evaluate the effectiveness of posters as a teaching tool and factors associated with HH quality. (2) Methods: A pre-post experimental intervention study was conducted with a total of 293 nursing students randomly assigned to two groups (experimental and control) who, before and after HH, took cell culture samples from their non-dominant hands. Only the experimental group was exposed to the poster. (3) Results: In the experimental group, significant differences were observed among students older than 22 years ( p  = 0.017; V = 0.188), with a higher percentage of failures (15.7% vs. 3.6%). Poster displaying was associated with passing, other variables being equal, although without statistical significance (ORa = 2.07; 95% CI = 0.81-5.26). Pre-practice hand contamination was weakly associated with lower HH quality (ORa = 0.99, 95% CI = 0.99-0.99). (4) Conclusions: The use of posters as a teaching method shows indications of efficacy. Prior hand contamination slightly affects the quality of HH. Further evaluation of teaching methods is needed to ensure good technical performance of HH to prevent the spread of infectious diseases during the COVID-19 pandemic.",2021,"Poster displaying was associated with passing, other variables being equal, although without statistical significance (ORa = 2.07; 95% CI = 0.81-5.26).",['293 nursing students'],[],"['quality of HH', 'hand hygiene (HH) compliance and effectiveness', 'lower HH quality']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}]",[],"[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",293.0,0.0217837,"Poster displaying was associated with passing, other variables being equal, although without statistical significance (ORa = 2.07; 95% CI = 0.81-5.26).","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Gázquez-López', 'Affiliation': 'Faculty of Health Sciences, University of Granada, 51001 Ceuta, Spain.'}, {'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Martínez-García', 'Affiliation': 'Faculty of Health Sciences, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'Adelina', 'Initials': 'A', 'LastName': 'Martín-Salvador', 'Affiliation': 'Faculty of Health Sciences, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'María Adelaida', 'Initials': 'MA', 'LastName': 'Álvarez-Serrano', 'Affiliation': 'Faculty of Health Sciences, University of Granada, 51001 Ceuta, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'García-García', 'Affiliation': 'Faculty of Health Sciences, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Caparros-Gonzalez', 'Affiliation': 'Faculty of Health Sciences, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'Pérez-Morente', 'Affiliation': 'Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph182111123']
3057,34766228,"Stachys schtschegleevii tea, matrix metalloproteinase, and disease severity in female rheumatoid arthritis patients: a randomized controlled clinical trial.","BACKGROUND


Stachys schtschegleevii (SSC) is a herbal medicine used to treat infections. To date, this is the first study aimed to investigate the effects of SSC tea on disease activity score (DAS), serum inflammatory biomarkers and matrix metalloproteinases (MMP-1 and MMP-3) among women with rheumatoid arthritis (RA).
METHODS


This pilot, triple-blind, randomized controlled clinical trial was conducted among forty-four women (age: 30-65 years) diagnosed with moderately active RA. Subjects were randomly assigned (1:1 ratio) into either SSC group (2.4 g/day SSC + 2.4 g/day black tea, n=22) or placebo (2.4 g/day black tea, n=22) for 8 weeks. Serum high-sensitivity C-reactive protein (hs-CRP), interleukin-1 beta (IL-1β), and MMPs were measured using ELISA. According to the American College of Rheumatology guideline considering hs-CRP, DAS28 was assessed.
RESULTS


Both study groups had respondent rates above 94.9%. The SSC intervention caused significant reductions in the number and the percent changes of the tender joints (SSC: -74.39% vs. placebo: -57.15%, mean differences= -0.77; P<0.05) and DAS28 [SSC: -32.44% vs. placebo: -22.32%, mean differences= -0.41, P<0.05). Unlike the intervention within SSC group that showed significant reductions in the mean serum levels of hs-CRP, IL-1β, and MMP-3, SSC caused significant MMP-3 reductions (SSC: -20.59% vs. placebo: 1.29%, P<0.05).
CONCLUSION


The SSC intervention showed an appropriate clinical efficacy for female RA patients, accompanying remarkable reductions in the number of tender and swollen joints, DAS28, and serum levels of MMP-3. This can provide additional insights to the interventional studies controlling RA-related pathological and inflammatory outcomes. Trial registration Prospectively registered at the Iranian Registry of Clinical Trials (IRCT), linked to the WHO Registry Network ( https://en.irct.ir/trial/11602 , IRCT registration number: IRCT2015032011335N5, Registration date:2015-05-12). Key Points • Stachys schtschegleevii improved clinical outcomes and attenuated disease severity in RA patients. • Stachys schtschegleevii ameliorated serum level of MMP-3 in RA patients.",2021,"Unlike the intervention within SSC group that showed significant reductions in the mean serum levels of hs-CRP, IL-1β, and MMP-3, SSC caused significant MMP-3 reductions (SSC: -20.59% vs. placebo: 1.29%, P<0.05).
","['female RA patients', 'forty-four women (age: 30-65 years) diagnosed with moderately active RA', 'RA patients', 'women with rheumatoid arthritis (RA', 'female rheumatoid arthritis patients']","['Stachys schtschegleevii (SSC', 'SSC tea', 'placebo', 'SSC']","['number of tender and swollen joints, DAS28, and serum levels of MMP-3', 'tender joints', 'mean serum levels of hs-CRP, IL-1β, and MMP-3, SSC caused significant MMP-3 reductions', 'disease activity score (DAS), serum inflammatory biomarkers and matrix metalloproteinases (MMP-1 and MMP-3', 'serum level of MMP-3', 'Serum high-sensitivity C-reactive protein (hs-CRP), interleukin-1 beta (IL-1β), and MMPs']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1083570', 'cui_str': 'Betonica'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C2001899', 'cui_str': 'MMP1 protein, human'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}]",44.0,0.398344,"Unlike the intervention within SSC group that showed significant reductions in the mean serum levels of hs-CRP, IL-1β, and MMP-3, SSC caused significant MMP-3 reductions (SSC: -20.59% vs. placebo: 1.29%, P<0.05).
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Mirtaheri', 'Affiliation': 'Department of Biochemistry and Dietetics, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Khabbazi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Nazemiyeh', 'Affiliation': 'Research Center for Pharmaceutical Nanotechnology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali-Asghar', 'Initials': 'AA', 'LastName': 'Ebrahimi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehrzad', 'Initials': 'M', 'LastName': 'Hajalilou', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Shakibay Novin', 'Affiliation': 'Department of Biochemistry and Dietetics, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Pirouzpanah', 'Affiliation': 'Molecular Medicine Research Center, Biomedicine Institute, Tabriz University of Medical Sciences, 5166614711, Tabriz, Eastern-Azerbaijan, Iran. pirouzpanah@gmail.com.'}]",Clinical rheumatology,['10.1007/s10067-021-05981-4']
3058,34766214,Comparison of two techniques for the management of 2-3 cm lower pole renal calculi in obese patients.,"OBJECTIVE


To compare the outcomes of mini percutaneous nephrolithotomy (mPNL) and retrograde intrarenal surgery (RIRS) for the management of 2-3 cm lower pole renal calculi (LPC) in obese patients.
PATIENTS AND METHODS


120 obese patients with 2-3 cm LPC were randomly divided into mPNL group and RIRS group. Demography, clinical characteristics, perioperative complications, and stone free rate (SFR) were recorded. Stone-free status means no stone on computed tomography 3 months after surgery, or residual fragments were less than 3 mm.
RESULTS


Baseline characteristics were similar between the two groups. The mean stone burden was 585.39 ± 131.06 mm 2  in the mPNL group and 548.64 ± 123.55 mm 2  in the RIRS group (P = 0.125). The SFR of mPNL group was significantly better than that of RIRS group (86.2% vs 61.4%, P = 0.002). Besides, the overall complication rate was 22.4% in the mPNL group and 7% in the RIRS group (P = 0.02). Patients performed with mPNL required longer length of hospital stay than those with RIRS (P = 0.001). There were no significant differences in operative time and stone composition between the two groups.
CONCLUSION


In our study, both mPNL and RIRS are safe and effective techniques for the treatment of 2-3 cm LPC in obese patients. Compared to RIRS, mPNL has better SFR at the expense of the higher incidence of complications and prolonged length of hospital stay.",2021,Patients performed with mPNL required longer length of hospital stay than those with RIRS (P = 0.001).,"['obese patients', '120 obese patients with 2-3\xa0cm LPC', '2-3\xa0cm lower pole renal calculi (LPC) in obese patients']","['mini percutaneous nephrolithotomy (mPNL) and retrograde intrarenal surgery (RIRS', 'RIRS', 'mPNL group and RIRS']","['Demography, clinical characteristics, perioperative complications, and stone free rate (SFR', 'longer length of hospital stay', 'operative time and stone composition', 'pole renal calculi', 'complications and prolonged length of hospital stay', 'overall complication rate', 'mean stone burden']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0428447', 'cui_str': 'Determination of stone composition'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",120.0,0.026671,Patients performed with mPNL required longer length of hospital stay than those with RIRS (P = 0.001).,"[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xia', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Ejun', 'Initials': 'E', 'LastName': 'Peng', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Yonghua', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Hailang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Xinguang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. zhqchen_8366@163.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. tangsk1990@163.com.'}]",World journal of urology,['10.1007/s00345-021-03872-6']
3059,34766208,Effect of the perception of breakfast consumption on subsequent appetite and energy intake in healthy males.,"PURPOSE


This study aimed to assess the effects of consuming a very-low-energy placebo breakfast on subsequent appetite and lunch energy intake.
METHODS


Fourteen healthy males consumed water-only (WAT), very-low-energy, viscous placebo (containing water, low-calorie flavoured squash, and xanthan gum; ~ 16 kcal; PLA), and whole-food (~ 573 kcal; FOOD) breakfasts in a randomised order. Subjects were blinded to the energy content of PLA and specific study aims. Venous blood samples were collected pre-breakfast, 60- and 180-min post-breakfast to assess plasma acylated ghrelin and peptide tyrosine tyrosine concentrations. Subjective appetite was measured regularly, and energy intake was assessed at an ad libitum lunch meal 195-min post-breakfast.
RESULTS


Lunch energy intake was lower during FOOD compared to WAT (P < 0.05), with no further differences between trials (P ≥ 0.132). Cumulative energy intake (breakfast plus lunch) was lower during PLA (1078 ± 274 kcal) and WAT (1093 ± 249 kcal), compared to FOOD (1554 ± 301 kcal; P < 0.001). Total area under the curve (AUC) for hunger, desire to eat and prospective food consumption were lower, and fullness was greater during PLA and FOOD compared to WAT (P < 0.05). AUC for hunger was lower during FOOD compared to PLA (P < 0.05). During FOOD, acylated ghrelin was suppressed compared to PLA and WAT at 60 min (P < 0.05), with no other hormonal differences between trials (P ≥ 0.071).
CONCLUSION


Consuming a very-low-energy placebo breakfast does not alter energy intake at lunch but may reduce cumulative energy intake across breakfast and lunch and attenuate elevations in subjective appetite associated with breakfast omission.
TRIAL REGISTRATION


NCT04735783, 2nd February 2021, retrospectively registered.",2021,"During FOOD, acylated ghrelin was suppressed compared to PLA and WAT at 60 min (P < 0.05), with no other hormonal differences between trials (P ≥ 0.071).
","['healthy males', 'Fourteen healthy males consumed water-only (WAT), very-low-energy, viscous placebo (containing water, low-calorie flavoured squash, and xanthan gum;\u2009~\u200916\xa0kcal; PLA), and whole-food (~\u2009573\xa0kcal; FOOD) breakfasts in a randomised order']","['consuming a very-low-energy placebo breakfast', 'breakfast consumption']","['subsequent appetite and energy intake', 'Cumulative energy intake (breakfast plus lunch', 'Total area under the curve (AUC) for hunger, desire to eat and prospective food consumption', 'AUC for hunger', 'Subjective appetite', 'Lunch energy intake', 'Venous blood samples']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0038076', 'cui_str': 'Squash'}, {'cui': 'C0078596', 'cui_str': 'xanthan gum'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0453870', 'cui_str': 'Whole food'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}]",14.0,0.125476,"During FOOD, acylated ghrelin was suppressed compared to PLA and WAT at 60 min (P < 0.05), with no other hormonal differences between trials (P ≥ 0.071).
","[{'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Slater', 'Affiliation': 'Musculoskeletal Physiology Research Group, Nutrition and Exercise Physiology, Sport, Health and Performance Enhancement Research Centre, School of Science and Technology, Clifton Campus, Nottingham Trent University, Nottingham, NG11 8NS, Nottinghamshire, UK.'}, {'ForeName': 'William J A', 'Initials': 'WJA', 'LastName': 'Mode', 'Affiliation': 'Musculoskeletal Physiology Research Group, Nutrition and Exercise Physiology, Sport, Health and Performance Enhancement Research Centre, School of Science and Technology, Clifton Campus, Nottingham Trent University, Nottingham, NG11 8NS, Nottinghamshire, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hough', 'Affiliation': 'Musculoskeletal Physiology Research Group, Nutrition and Exercise Physiology, Sport, Health and Performance Enhancement Research Centre, School of Science and Technology, Clifton Campus, Nottingham Trent University, Nottingham, NG11 8NS, Nottinghamshire, UK.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'James', 'Affiliation': 'Musculoskeletal Physiology Research Group, Nutrition and Exercise Physiology, Sport, Health and Performance Enhancement Research Centre, School of Science and Technology, Clifton Campus, Nottingham Trent University, Nottingham, NG11 8NS, Nottinghamshire, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Sale', 'Affiliation': 'Musculoskeletal Physiology Research Group, Nutrition and Exercise Physiology, Sport, Health and Performance Enhancement Research Centre, School of Science and Technology, Clifton Campus, Nottingham Trent University, Nottingham, NG11 8NS, Nottinghamshire, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, Leicestershire, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'Musculoskeletal Physiology Research Group, Nutrition and Exercise Physiology, Sport, Health and Performance Enhancement Research Centre, School of Science and Technology, Clifton Campus, Nottingham Trent University, Nottingham, NG11 8NS, Nottinghamshire, UK. David.Clayton@ntu.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-021-02727-5']
3060,34766657,Re-Analysis of the STEADY-PD II Trial-Evidence for Slowing the Progression of Parkinson's Disease.,"BACKGROUND


Recent examination of the STEADY-PD III isradipine clinical trial data concluded that early-stage Parkinson's disease (PD) participants who had longer exposure to isradipine had a significant delay in their need for symptomatic medication, as well as a lower medication burden at the end of the trial. These findings suggest that greater exposure to isradipine might slow disease progression.
OBJECTIVES


To test this hypothesis, the data from the STEADY-PD II isradipine clinical trial, in which an extended-release (ER) formulation of the drug was used, was re-examined.
METHODS


The re-analysis of the STEADY-PD II data was restricted to participants assigned placebo or tolerable isradipine treatment (10 mg isradipine/day or less). The effect of isradipine treatment was assessed by Unified Parkinson's Disease Rating Scale (UPDRS) at the end of the 52-week trial, rather than by last observation carried forward at the beginning of symptomatic therapy.
RESULTS


Participant cohorts were well-matched for baseline disability, initial disease progression, and time to initiation of symptomatic therapy. Participants given 10 mg/day ER isradipine had significantly smaller total and part 3 UPDRS scores at the end of the trial than did the placebo cohort. Post hoc adjustment for symptomatic therapy diminished the statistical significance of these differences. In those participants not taking a monoamine oxidase B inhibitor, the progression in UPDRS scores also was significantly reduced.
CONCLUSIONS


These results are consistent with the recent secondary analysis of the STEADY-PD III clinical trial-suggesting that clinically attainable brain exposure to isradipine may slow early-stage PD progression. © 2021 International Parkinson and Movement Disorder Society.",2021,Participants given 10 mg/day ER isradipine had significantly smaller total and part 3 UPDRS scores at the end of the trial than did the placebo cohort.,"[""early-stage Parkinson's disease (PD) participants who had longer exposure to""]","['placebo or tolerable isradipine', 'placebo', 'ER isradipine', 'isradipine']","['smaller total and part 3 UPDRS scores', 'progression in UPDRS scores', ""Unified Parkinson's Disease Rating Scale (UPDRS"", 'baseline disability, initial disease progression, and time to initiation of symptomatic therapy']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.60841,Participants given 10 mg/day ER isradipine had significantly smaller total and part 3 UPDRS scores at the end of the trial than did the placebo cohort.,"[{'ForeName': 'D James', 'Initials': 'DJ', 'LastName': 'Surmeier', 'Affiliation': 'Department of Neuroscience, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Nguyen', 'Affiliation': 'Cavalon Therapeutics, Berkeley, California, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lancki', 'Affiliation': 'Biostatistics Collaboration Center, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Venuto', 'Affiliation': 'Department of Neurology, Center for Health and Technology, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Oakes', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Simuni', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Wyse', 'Affiliation': 'Cure Parkinsons, London, United Kingdom.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28850']
3061,34766589,The role of rehabilitation and vitamin D supplementation on motor and psychological outcomes in poststroke patients.,"ABSTRACT


Post-Stroke depression affects between 12% and 72% of patients who have suffered a stroke. The association between low serum levels of 25-hydroxyvitamin D (25(OH) D) and increased risk of depression is reported in both stroke and non-stroke patients. Similarly, high 25(OH) D levels might be associated with greater functional improvement during rehabilitation program.We wanted to investigate the effects of an intensive rehabilitation on poststroke outcomes. We wondered if the daily rehabilitation of motor and cognitive functions could also have an effect on mood and functional abilities in addition to or as an alternative to vitamin D supplementation.We conducted a 12-week, randomized trial, double blind, parallel, monocentric clinical trial of 40 patients undergoing intensive neuro-rehabilitation treatment at a specialized care facility for ischemic or hemorrhagic brain stroke. Participants were randomly assigned, in a 1:1 ratio, to 1 of 2 parallel groups: in the experimental group, 2000 IU/day of oral cholecalciferol was administered; in the control group patients were not taking vitamin D supplementation. Patients underwent a text evaluation to investigate psychological and motor outcomes.Significant intra-group difference in outcomes measures was found but not between control group and experimental group. In the vitamin D group, we highlighted significant differences between T0 and T1 in calcium (P < .001), vitamin D (P < .001), in Montgomery Aasberg Depression Rating Scale (P = .001), and in Functional Independent Measures (P < .001). In the health control group, we found a significant difference in calcium (P = .003), vitamin D (P < .001), Montgomery Aasberg Depression Rating Scale (P = 0.006), in general self-efficacy (P = .009), and in Functional Independent Measures (P < .001).Our results show that the beneficial effect on mood and functional recovery is mainly due to neurorehabilitation rather than vitamin D supplementation.",2021,"In the health control group, we found a significant difference in calcium (P = .003), vitamin D (P < .001), Montgomery Aasberg Depression Rating Scale (P = 0.006), in general self-efficacy (P = .009), and in Functional Independent Measures (P < .001).Our results show that the beneficial effect on mood and functional recovery is mainly due to neurorehabilitation rather than vitamin D supplementation.","['40 patients undergoing intensive neuro-rehabilitation treatment at a specialized care facility for ischemic or hemorrhagic brain stroke', 'poststroke patients']","['vitamin D supplementation', 'vitamin D', 'rehabilitation and vitamin D supplementation', 'intensive rehabilitation', 'oral cholecalciferol']","['Montgomery Aasberg Depression Rating Scale', 'vitamin D', 'T0 and T1 in calcium', 'general self-efficacy', 'poststroke outcomes', 'low serum levels of 25-hydroxyvitamin D (25(OH) D) and increased risk of depression', 'calcium', 'motor and psychological outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",40.0,0.149103,"In the health control group, we found a significant difference in calcium (P = .003), vitamin D (P < .001), Montgomery Aasberg Depression Rating Scale (P = 0.006), in general self-efficacy (P = .009), and in Functional Independent Measures (P < .001).Our results show that the beneficial effect on mood and functional recovery is mainly due to neurorehabilitation rather than vitamin D supplementation.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Torrisi', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"" - S.S. 113 C.da Casazza, Messina, Italy.'}, {'ForeName': 'Lilla', 'Initials': 'L', 'LastName': 'Bonanno', 'Affiliation': ''}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Formica', 'Affiliation': ''}, {'ForeName': 'Francesca Antonia', 'Initials': 'FA', 'LastName': 'Arcadi', 'Affiliation': ''}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Cardile', 'Affiliation': ''}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Cimino', 'Affiliation': ''}, {'ForeName': 'Placido', 'Initials': 'P', 'LastName': 'Bramanti', 'Affiliation': ''}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Morini', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000027747']
3062,34766586,Relationship between the proficiency level and anxiety-reducing effect in a one-time heart rate variability biofeedback: A randomized controlled trial.,"INTRODUCTION


Previous studies have reported that the proficiency level of heart rate variability biofeedback (HRVBF) contributes significantly to the anxiety-reducing effects in continuous HRVBF interventions. Meanwhile, anxiety-reducing effects have been confirmed in one-time HRVBF interventions as well as continuous HRVBF; however, no study has analyzed the relationship between the proficiency level of a one-time HRVBF and its anxiety-reducing effects. To pursuit the effectiveness of a one-time HRVBF intervention, it is necessary to clarify whether the proficiency level is an important predictor of anxiety-reducing effects from a dose-response relationship between these 2 variables. The purpose of this study was to examine the dose-response relationship between the proficiency level and anxiety-reducing effects of a one-time HRVBF.
METHODS


This study was a single-blinded, randomized, controlled trial with stratification based on trait anxiety of the State-Trait Anxiety Inventory-JYZ. In total, 45 healthy young males aged 20 to 30 years were allocated to the HRVBF or control group with simple breathing at rest. The intervention was performed for 15 minute in each group. The state anxiety score of the State-Trait Anxiety Inventory-JYZ was measured to evaluate the anxiety-reducing effect before and after training.
RESULTS


The results showed no significant linear relationship between the proficiency level and anxiety-reducing effect, and variations in the proficiency level were observed post-intervention in the HRVBF group. A significant anxiety-reducing effect was only observed in the HRVBF group (P = .001, effect size r = 0.62).
CONCLUSIONS


These results suggest that there is no close relationship between the proficiency level and anxiety-reducing effect in one-time HRVBF and that HRVBF is effective in reducing anxiety regardless of individual differences in the proficiency level. Therefore, a one-time HRVBF may be a useful breathing technique for reducing state anxiety without specific education and breathing techniques.
TRIAL REGISTRATION


University Hospital Medical Information Network Clinical Trial Registry (UMIN000041760).",2021,"A significant anxiety-reducing effect was only observed in the HRVBF group (P = .001, effect size",['45 healthy young males aged 20 to 30\u200ayears'],"['HRVBF', 'HRVBF or control group with simple breathing at rest']","['proficiency level and anxiety-reducing effect, and variations in the proficiency level', 'anxiety-reducing effect', 'state anxiety score of the State-Trait Anxiety Inventory-JYZ']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0443144', 'cui_str': 'At rest'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",45.0,0.0407393,"A significant anxiety-reducing effect was only observed in the HRVBF group (P = .001, effect size","[{'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Saito', 'Affiliation': 'Graduate School of Health Sciences, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sawamura', 'Affiliation': 'Department of Rehabilitation Science, Faculty of Health Sciences, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Rehabilitation Science, Faculty of Health Sciences, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Sakai', 'Affiliation': 'Department of Rehabilitation Science, Faculty of Health Sciences, Hokkaido University, Sapporo, Japan.'}]",Medicine,['10.1097/MD.0000000000027742']
3063,34766584,Effects of attentional bias modification on chronic low back pain in older outpatients: A randomized crossover trial (pilot study).,"OBJECTIVES


In the present study, the effect of attentional bias modification (ABM) on older outpatients, with chronic low back pain, was examined.
DESIGN


This was a single-center, randomized, single-blinded, crossover trial and patients were randomly divided in a 1:1 allocation ratio into two groups: an ABM Leading group and an ABM Trailing group.
PARTICIPANTS


Forty-three outpatients with chronic low back pain participated.
INTERVENTIONS


Patients were evaluated four times and the treatments were ABM + Normal intervention or Normal intervention only.
OUTCOMES


Outcome measures included pain intensity on the Numerical Rating Scale, the Pain Catastrophizing Scale, Fear-Avoidance Beliefs Questionnaire, Hospital Anxiety and Depression Scale, Somatic Symptom Scale-8, and EuroQol 5 Dimension-3 levels questionnaire. In addition, we performed the 30-second Chair-Stand test and the Timed Up & Go test for physical function evaluations.
RESULTS


There was no change in pain intensity due to ABM. However, the total Pain Catastrophizing Scale score was significantly decreased, and the EuroQol 5 Dimension-3 levels questionnaire and 30-second chair-stand test were significantly improved (P <.05).
TRIAL REGISTRATION


The Health Science Ethics Committee, Graduate School of Biomedical Sciences, Nagasaki University (permit number: 17060861), and the clinical trial was registered with UMIN (UMIN000029424).",2021,"However, the total Pain Catastrophizing Scale score was significantly decreased, and the EuroQol 5 Dimension-3 levels questionnaire and 30-second chair-stand test were significantly improved (P <.05).
","['older outpatients', 'Nagasaki University', 'Forty-three outpatients with chronic low back pain participated', 'older outpatients, with chronic low back pain, was examined']","['attentional bias modification (ABM', 'ABM Leading group and an ABM Trailing group', 'attentional bias modification', 'ABM\u200a+\u200aNormal intervention or Normal intervention only']","['chronic low back pain', 'pain intensity', 'EuroQol 5 Dimension-3 levels questionnaire and 30-second chair-stand test', 'total Pain Catastrophizing Scale score', 'pain intensity on the Numerical Rating Scale, the Pain Catastrophizing Scale, Fear-Avoidance Beliefs Questionnaire, Hospital Anxiety and Depression Scale, Somatic Symptom Scale-8, and EuroQol 5 Dimension-3 levels questionnaire']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}]",43.0,0.0494154,"However, the total Pain Catastrophizing Scale score was significantly decreased, and the EuroQol 5 Dimension-3 levels questionnaire and 30-second chair-stand test were significantly improved (P <.05).
","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Wajinkai Medical Corporation, Wajinkai Hospital, Nagasaki, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Nishi', 'Affiliation': 'Macroscopic Anatomy, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Nakashima', 'Affiliation': 'Unit of Rehabilitation Sciences, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Moriuchi', 'Affiliation': 'Unit of Rehabilitation Sciences, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Iso', 'Affiliation': 'Unit of Rehabilitation Sciences, Tokyo Kasei University, Saitama, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Koseki', 'Affiliation': 'Unit of Rehabilitation Sciences, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Tabira', 'Affiliation': 'School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Higashi', 'Affiliation': 'Unit of Rehabilitation Sciences, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.'}]",Medicine,['10.1097/MD.0000000000027738']
3064,34766461,The need for speed in advanced non-small cell lung cancer: A population kinetics assessment.,"BACKGROUND


Systemic therapy prolongs overall survival (OS) in advanced non-small cell lung cancer (NSCLC), but diagnostic tests, staging and molecular profiling take time, and this can delay therapy initiation. OS approximates first-order kinetics.
METHODS


We used OS of chemo-naive NSCLC patients on a placebo/best supportive care trial arm to estimate % of patients dying while awaiting therapy. We digitized survival curves from eight studies, calculated OS half-life, then estimated the proportion surviving after different times of interest (t n  ) using the formula:  X     =     exp   -   t   n   ∗   0   .693   /   t   1   /   2            , where EXP signifies exponential, * indicates multiplication, 0.693 is the natural log of 2, and t 1/2  is the survival half-life in weeks.
RESULTS


Across trials, the OS half-life for placebo/best supportive care in previously untreated NSCLC was 19.5 weeks. Hence, based on calculations using the formula above, if therapy were delayed by 1, 2, 3, or 4 weeks then 4%, 7%, 10%, and 13% of all patients, respectively, would die while awaiting treatment. Others would become too sick to consider therapy even if still alive.
CONCLUSIONS


This quantifies why rapid baseline testing and prompt therapy initiation are important in advanced NSCLC. It also illustrates why screening procedures for clinical trial inclusion must be faster. Otherwise, it is potentially hazardous for a patient to be considered for a trial due to risk of death or deterioration while awaiting eligibility assessment. It is also important to not delay initiation of systemic therapy for procedures that add relatively little value, such as radiotherapy for small, asymptomatic brain metastases.",2021,"Across trials, the OS half-life for placebo/best supportive care in previously untreated NSCLC was 19.5 weeks.","['advanced non-small cell lung cancer (NSCLC', 'patients dying while awaiting therapy']",['placebo'],['overall survival (OS'],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.253317,"Across trials, the OS half-life for placebo/best supportive care in previously untreated NSCLC was 19.5 weeks.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stewart', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Maziak', 'Affiliation': 'Department of Surgery, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Moore', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Stephanie Y', 'Initials': 'SY', 'LastName': 'Brule', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Marcio', 'Initials': 'M', 'LastName': 'Gomes', 'Affiliation': 'Department of Pathology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Harman', 'Initials': 'H', 'LastName': 'Sekhon', 'Affiliation': 'Department of Pathology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Dennie', 'Affiliation': 'Department of Diagnostic Imaging, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Lo', 'Affiliation': 'Department of Pathology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fung-Kee-Fung', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'John-Peter', 'Initials': 'JP', 'LastName': 'Bradford', 'Affiliation': 'Life Saving Therapies Network, Ottawa, Ontario, Canada.'}, {'ForeName': 'Martin Neil', 'Initials': 'MN', 'LastName': 'Reaume', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}]",Cancer medicine,['10.1002/cam4.4411']
3065,34766453,Effectiveness of nurse-led counselling and education on self-efficacy of patients with acute coronary syndrome: A randomized controlled trial.,"AIM


Adherence to lifestyle recommendations, medical regimens and cardiac rehabilitation is poor among patients with acute coronary syndrome. The aim of this study was to examine the effect of nurse-led counselling and education using a person-centred care approach on short-term cardiac self-efficacy in patients with acute coronary syndrome.
DESIGN


A parallel, two-armed, randomized controlled trial was conducted.
METHODS


One hundred twenty patients who were hospitalized with diagnosis of acute coronary syndrome were selected and randomly assigned into intervention (n = 60) or control (n = 60) groups. In the intervention group, in addition to routine care, the nurse-led counselling and education programme included two face-to-face sessions, two telephone counselling and education sessions, using the person-centred care approach. Participants in the control group received only routine care. Data were collected using the cardiac self-efficacy scale before the intervention and 1 month after discharge.
RESULTS


After the intervention, we found that cardiac self-efficacy, including the perceived self-efficacy to control symptoms and maintain function, was statistically significantly higher in the intervention group than the control group.",2021,"After the intervention, we found that cardiac self-efficacy, including the perceived self-efficacy to control symptoms and maintain function, was statistically significantly higher in the intervention group than the control group.","['patients with acute coronary syndrome', 'One hundred twenty patients who were hospitalized with diagnosis of acute coronary syndrome']","['routine care', 'nurse-led counselling and education', 'nurse-led counselling and education using a person-centred care approach', 'nurse-led counselling and education programme included two face-to-face sessions, two telephone counselling and education sessions, using the person-centred care approach']","['cardiac self-efficacy', 'cardiac self-efficacy scale', 'perceived self-efficacy to control symptoms and maintain function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",120.0,0.0214565,"After the intervention, we found that cardiac self-efficacy, including the perceived self-efficacy to control symptoms and maintain function, was statistically significantly higher in the intervention group than the control group.","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Bagheri', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shakeri', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Ali-Mohammad', 'Initials': 'AM', 'LastName': 'Nazari', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Shahrbanoo', 'Initials': 'S', 'LastName': 'Goli', 'Affiliation': 'Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Khajeh', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mardani', 'Affiliation': 'Nursing Care Research Center, Department of Medical Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zeljko', 'Initials': 'Z', 'LastName': 'Vlaisavljevic', 'Affiliation': 'University Clinical Center of Serbia, Clinic for Gastroenterology and Hepatoligia, Belgarade, Serbia.'}]",Nursing open,['10.1002/nop2.1129']
3066,34766424,Dapagliflozin and atrial fibrillation in heart failure with reduced ejection fraction: Insights from DAPA-HF.,"AIMS


Among patients with heart failure and reduced ejection fraction (HFrEF), those with atrial fibrillation (AF) may respond differently to certain treatments than patients without AF. We investigated the efficacy and safety of dapagliflozin in patients with HFrEF with and without AF in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF). We also examined the effect of dapagliflozin on new-onset AF.
METHODS AND RESULTS


The primary outcome was the composite of an episode of worsening HF (HF hospitalization or urgent HF visit requiring intravenous therapy) or cardiovascular death. Of the 4744 patients randomized, 1910 (40.3%) had ""any AF"" (history of AF or AF on enrolment electrocardiogram). Compared with placebo, dapagliflozin reduced the risk of worsening HF or cardiovascular death to a similar extent in patients with and without any AF (HR 0.75 [95% CI, 0.62-0.92]) and 0.74 [95% CI, 0.62-0.88]), respectively; P for interaction = 0.88). Consistent benefits were observed for the components of the primary outcome, all-cause mortality, and improvement of Kansas City Cardiomyopathy Questionnaire total symptom score. Among patients without AF at baseline, dapagliflozin did not significantly reduce the risk of new-onset AF compared with placebo (HR 0.86 [95% CI, 0.60-1.22]). However, patients with new-onset AF had a 5 to 6-fold higher risk of adverse outcomes when compared to those without incident AF.
CONCLUSIONS


Dapagliflozin, compared with placebo, reduced the risk of worsening HF events, cardiovascular death, and all-cause death, and improved symptoms, in patients with and without AF. Dapagliflozin did not reduce the risk of new-onset AF. This article is protected by copyright. All rights reserved.",2021,"Among patients without AF at baseline, dapagliflozin did not significantly reduce the risk of new-onset AF compared with placebo (HR 0.86 [95% CI, 0.60-1.22]).","['patients with HFrEF with and without AF in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF', '4744 patients randomized, 1910 (40.3%) had ""any AF"" (history of AF or AF on enrolment electrocardiogram', 'heart failure with reduced ejection fraction', 'patients with heart failure and reduced ejection fraction (HFrEF), those with atrial fibrillation (AF']","['Dapagliflozin', 'placebo, dapagliflozin', 'placebo', 'dapagliflozin']","['risk of new-onset AF', 'risk of worsening HF or cardiovascular death', 'risk of worsening HF events, cardiovascular death, and all-cause death, and improved symptoms', 'efficacy and safety', 'composite of an episode of worsening HF (HF hospitalization or urgent HF visit requiring intravenous therapy) or cardiovascular death', 'adverse outcomes', 'cause mortality, and improvement of Kansas City Cardiomyopathy Questionnaire total symptom score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0729790', 'cui_str': 'H/O: atrial fibrillation'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",4744.0,0.417609,"Among patients without AF at baseline, dapagliflozin did not significantly reduce the risk of new-onset AF compared with placebo (HR 0.86 [95% CI, 0.60-1.22]).","[{'ForeName': 'Jawad H', 'Initials': 'JH', 'LastName': 'Butt', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'De Boer', 'Affiliation': 'Department of Cardiology, University Medical Center and University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III, Saarland University Hospital, Saarland University, Homburg, Saar, Germany.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States.""}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Howlett', 'Affiliation': 'Cumming School of Medicine and Libin Cardiovascular Institute, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, Connecticut, United States.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City; The George Institute for Global Health, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Poland.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States.""}, {'ForeName': 'John Jv', 'Initials': 'JJ', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}]",European journal of heart failure,['10.1002/ejhf.2381']
3067,34766909,Dropout From an Internet-Delivered Cognitive Behavioral Therapy Intervention for Adults With Depression and Anxiety: Qualitative Study.,"BACKGROUND


Treatment dropout continues to be reported from internet-delivered cognitive behavioral therapy (iCBT) interventions, and lower completion rates are generally associated with lower treatment effect sizes. However, evidence is emerging to suggest that completion of a predefined number of modules is not always necessary for clinical benefit or consideration of the needs of each individual patient.
OBJECTIVE


The aim of this study is to perform a qualitative analysis of patients' experiences with an iCBT intervention in a routine care setting to achieve a deeper insight into the phenomenon of dropout.
METHODS


A total of 15 purposively sampled participants (female: 8/15, 53%) from a larger parent randomized controlled trial were interviewed via telephone using a semistructured interview schedule that was developed based on the existing literature and research on dropout in iCBT. Data were analyzed using a descriptive-interpretive approach.
RESULTS


The experience of treatment leading to dropout can be understood in terms of 10 domains: relationship to technology, motivation to start, background knowledge and attitudes toward iCBT, perceived change in motivation, usage of the program, changes due to the intervention, engagement with content, experience interacting with the supporter, experience of web-based communication, and termination of the supported period.
CONCLUSIONS


Patients who drop out of treatment can be distinguished in terms of their change in motivation: those who felt ready to leave treatment early and those who had negative reasons for dropping out. These 2 groups of participants have different treatment experiences, revealing the potential attributes and nonattributes of dropout. The reported between-group differences should be examined further to consider those attributes that are strongly descriptive of the experience and regarded less important than those that have become loosely affiliated.",2021,"CONCLUSIONS


Patients who drop out of treatment can be distinguished in terms of their change in motivation: those who felt ready to leave treatment early and those who had negative reasons for dropping out.","['A total of 15 purposively sampled participants (female: 8/15, 53%) from a larger parent randomized controlled trial', 'Adults With Depression and Anxiety', ""patients' experiences with an""]","['iCBT intervention', 'Internet-Delivered Cognitive Behavioral Therapy Intervention']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],15.0,0.056895,"CONCLUSIONS


Patients who drop out of treatment can be distinguished in terms of their change in motivation: those who felt ready to leave treatment early and those who had negative reasons for dropping out.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lawler', 'Affiliation': 'E-Mental Health Research Group, School of Psychology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Earley', 'Affiliation': 'E-Mental Health Research Group, School of Psychology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Timulak', 'Affiliation': 'E-Mental Health Research Group, School of Psychology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Enrique', 'Affiliation': 'E-Mental Health Research Group, School of Psychology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'E-Mental Health Research Group, School of Psychology, Trinity College Dublin, Dublin, Ireland.'}]",JMIR formative research,['10.2196/26221']
3068,34766835,Outcomes from Returning Individual versus Only Study-Wide Biomonitoring Results in an Environmental Exposure Study Using the Digital Exposure Report-Back Interface (DERBI).,"BACKGROUND


Study participants want to receive their biomonitoring results for environmental chemicals, and ethics guidelines encourage reporting back. However, few studies have quantitively assessed participants' responses to individual exposure reports, and digital methods have not been evaluated.
OBJECTIVES


We isolated effects of receiving personal results vs. only study-wide findings and investigated whether effects differed for Black participants.
METHODS


We randomly assigned a subset of 295 women from the Child Health and Development Studies, half of whom were Black, to receive a report with personal environmental chemical results or only study-wide (aggregate) findings. Reports included results for 42 chemicals and lipids and were prepared using the Digital Exposure Report-Back Interface (DERBI). Women were interviewed before and after viewing their report. We analyzed differences in website activity, emotional responses, and intentions to participate in future research by report type and race using Wilcoxon rank sum tests, Wilcoxon-Pratt signed ranks tests, and multiple regression.
RESULTS


The personal report group spent approximately twice as much time on their reports as the aggregate group before the post-report-back interview. Among personal-report participants ( n = 93 ), 84% (78) viewed chemical group information for at least one personal result highlighted on their home page; among aggregate-report participants ( n = 94 ), 66% (62) viewed any chemical group page. Both groups reported strong positive feelings (curious, informed, interested, respected) about receiving results before and after report-back and mild negative feelings (helpless, scared, worried). Although most participants remained unworried after report-back, worry increased by a small amount in both groups. Among Black participants, higher post report-back worry was associated with having high levels of chemicals.
CONCLUSIONS


Participants were motivated by their personal results to access online information about chemical sources and potential health effects. Report-back was associated with a small increase in worry, which could motivate appropriate action. Personal report-back increased engagement with exposure reports among Black participants. https://doi.org/10.1289/EHP9072.",2021,"Both groups reported strong positive feelings (curious, informed, interested, respected) about receiving results before and after report-back and mild negative feelings (helpless, scared, worried).","['295 women from the Child Health and Development Studies, half of whom were Black, to receive a report with personal environmental chemical results or only study-wide (aggregate) findings', 'Black participants', 'Among personal-report participants ( n = 93 ), 84% (78) viewed chemical group information for at least one personal result highlighted on their home page; among aggregate-report participants ( n = 94 ), 66% (62) viewed any chemical group page']",[],"['website activity, emotional responses, and intentions to participate in future research by report type and race using Wilcoxon rank sum tests, Wilcoxon-Pratt signed ranks tests, and multiple regression', 'Digital Exposure Report-Back Interface (DERBI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}]",[],"[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0585733', 'cui_str': 'Report type'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0242928', 'cui_str': 'Rank-Sum Tests'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",295.0,0.0645659,"Both groups reported strong positive feelings (curious, informed, interested, respected) about receiving results before and after report-back and mild negative feelings (helpless, scared, worried).","[{'ForeName': 'Julia Green', 'Initials': 'JG', 'LastName': 'Brody', 'Affiliation': 'Silent Spring Institute, Newton, Massachusetts, USA.'}, {'ForeName': 'Piera M', 'Initials': 'PM', 'LastName': 'Cirillo', 'Affiliation': 'Public Health Institute, Oakland, California, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Boronow', 'Affiliation': 'Silent Spring Institute, Newton, Massachusetts, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Havas', 'Affiliation': 'Participant Advisory Council, Child Health and Development Studies, Public Health Institute, Oakland, California, USA.'}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Plumb', 'Affiliation': 'Plumbline Coaching and Consulting, Omaha, Nebraska, USA.'}, {'ForeName': 'Herbert P', 'Initials': 'HP', 'LastName': 'Susmann', 'Affiliation': 'Department of Biostatistics, School of Public Health and Health Science, University of Massachusetts Amherst, Amherst, Massachusetts, USA.'}, {'ForeName': 'Krzysztof Z', 'Initials': 'KZ', 'LastName': 'Gajos', 'Affiliation': 'Computer Science, Harvard John A. Paulson School of Engineering and Applied Sciences, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Cohn', 'Affiliation': 'Public Health Institute, Oakland, California, USA.'}]",Environmental health perspectives,['10.1289/EHP9072']
3069,34766822,Effects of control strategies on the activation of unwanted intrusive thoughts in elite athletes.,"Unwanted intrusive thoughts (UITs) are negative ruminations that occur commonly and show similar characteristics between clinical and nonclinical forms. Despite their prevalence and impact, the control processes of UITs remain unclear. This study aimed to capture the effects of three thought-control strategies on UITs through an interventional design with individualized choking thoughts among Elite athletes, while measuring behavioral and brain responses. Ninety athletes recollected recent ""choking"" experiences prior to being randomized into one of three groups that used either acceptance, suppression, or passive monitoring (control condition). The activation of choking thoughts during and after the thought control intervention was gauged through three measurement approaches, including conscious presence in mind, priming, as well as the amplitudes of the P3b and N400 event-related potentials (ERPs). To strengthen the causal inferences concerning thought control strategies, athletes' working memory capacity was measured and controlled at baseline. Results indicated that, relative to passive monitoring, suppression led to enhanced priming and reduced conscious presence of UITs, whereas acceptance resulted in an opposite pattern of reduced priming and increased conscious presence of UITs. Moreover, UIT-related stimuli elicited less negative-going N400 amplitudes and more positive-going P3b amplitudes than UIT-irrelevant stimuli, although no effect of thought control strategies was identified on the ERPs. These findings contribute to the theoretical and mechanistic understanding of UIT control processes by revealing subtle effects of two fundamental UIT control strategies: suppression and acceptance. Such insights also bear meaningful applied implications. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Moreover, UIT-related stimuli elicited less negative-going N400 amplitudes and more positive-going P3b amplitudes than UIT-irrelevant stimuli, although no effect of thought control strategies was identified on the ERPs.","['Elite athletes', 'Ninety athletes recollected recent ""choking"" experiences prior', 'elite athletes']","['acceptance, suppression, or passive monitoring (control condition']","['conscious presence of UITs', 'behavioral and brain responses', 'UIT-related stimuli elicited less negative-going N400 amplitudes and more positive-going P3b amplitudes', 'activation of choking thoughts']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0008301', 'cui_str': 'Choking'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0558066', 'cui_str': 'Intrusive thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008301', 'cui_str': 'Choking'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}]",,0.0258065,"Moreover, UIT-related stimuli elicited less negative-going N400 amplitudes and more positive-going P3b amplitudes than UIT-irrelevant stimuli, although no effect of thought control strategies was identified on the ERPs.","[{'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Educational Psychology and Learning System, Florida State University.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Folstein', 'Affiliation': 'Department of Psychology, Florida State University.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Appelbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine.'}, {'ForeName': 'Gershon', 'Initials': 'G', 'LastName': 'Tenenbaum', 'Affiliation': 'Department of Educational Psychology and Learning System, Florida State University.'}]",Journal of experimental psychology. Human perception and performance,['10.1037/xhp0000945']
3070,34766812,"Individual and school predictors of teacher stress, coping, and wellness during the COVID-19 pandemic.","The Coronavirus disease 2019 (COVID-19) pandemic created unprecedented challenges for the U.S. education system and for teachers. The present study examined correlates and predictors of teacher well-being in the immediate aftermath of school closures related to the pandemic. Data were collected as part of a larger group randomized trial. Six hundred and thirty-nine teachers completed surveys about their stress, coping, health, job satisfaction, and internalizing symptoms in Fall 2019, before the pandemic, and May 2020, during the pandemic. Teachers also provided ratings during COVID-19 of their teaching, student attendance and engagement, and concern about students and families. Teachers reported lower levels of work-related stress after the pandemic's onset compared to their prepandemic levels. Multilevel regression analyses revealed teacher confidence in their ability to manage student behaviors as a consistent and robust predictor of teacher well-being outcomes. Additionally, pre-COVID-19 school-level factors measured in Fall 2019, including collegial school leadership and fair and equitable school discipline structures, also predicted aspects of teacher well-being at the onset of COVID-19. Findings suggest the importance of teacher competence and perceived efficacy in managing student behavior and engaging them in learning to help them adapt to the stressors of a pandemic. Additionally, aspects of organizational health and climate may also help facilitate or hinder teacher adjustment. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,Multilevel regression analyses revealed teacher confidence in their ability to manage student behaviors as a consistent and robust predictor of teacher well-being outcomes.,['Six hundred and thirty-nine teachers completed surveys about their'],[],"['stress, coping, health, job satisfaction, and internalizing symptoms', 'collegial school leadership and fair and equitable school discipline structures', 'levels of work-related stress']","[{'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",639.0,0.0854501,Multilevel regression analyses revealed teacher confidence in their ability to manage student behaviors as a consistent and robust predictor of teacher well-being outcomes.,"[{'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Herman', 'Affiliation': 'Missouri Prevention Science Institute, University of Missouri.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sebastian', 'Affiliation': 'Missouri Prevention Science Institute, University of Missouri.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Reinke', 'Affiliation': 'Missouri Prevention Science Institute, University of Missouri.'}, {'ForeName': 'Francis L', 'Initials': 'FL', 'LastName': 'Huang', 'Affiliation': 'Missouri Prevention Science Institute, University of Missouri.'}]","School psychology (Washington, D.C.)",['10.1037/spq0000456']
3071,34766811,Equity-focused PBIS approach reduces racial inequities in school discipline: A randomized controlled trial.,"We assessed the effects of a whole-school equity intervention implemented within a school-wide positive behavioral interventions and supports (PBIS) framework on racial inequities in school discipline in eight elementary schools with inequitable referrals for Black students. The intervention involved assessing patterns of racial disparities in school discipline decisions and providing professional development on adapting school-wide behavior systems to improve cultural responsiveness through concrete strategies targeting the patterns. After consent and matching on existing levels of racial inequities, half of the schools were randomly assigned to receive the intervention. Analyses showed that schools receiving the intervention had significant decreases in racial disparities in school discipline and rates of office discipline referrals (ODRs) for Black students, while control schools had minimal change. Results are discussed in terms of improving equity in school discipline within multitiered systems of support. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Analyses showed that schools receiving the intervention had significant decreases in racial disparities in school discipline and rates of office discipline referrals (ODRs) for Black students, while control schools had minimal change.","['school discipline', 'eight elementary schools with inequitable referrals for Black students']","['whole-school equity intervention implemented within a school-wide positive behavioral interventions and supports (PBIS) framework', 'Equity-focused PBIS approach']",['racial disparities in school discipline and rates of office discipline referrals (ODRs'],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]",,0.0419437,"Analyses showed that schools receiving the intervention had significant decreases in racial disparities in school discipline and rates of office discipline referrals (ODRs) for Black students, while control schools had minimal change.","[{'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'McIntosh', 'Affiliation': 'Special Education and Clinical Sciences, University of Oregon.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Girvan', 'Affiliation': 'Special Education and Clinical Sciences, University of Oregon.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fairbanks Falcon', 'Affiliation': 'Special Education and Clinical Sciences, University of Oregon.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'McDaniel', 'Affiliation': 'College of Education, University of Alabama.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Smolkowski', 'Affiliation': 'Oregon Research Institute.'}, {'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Bastable', 'Affiliation': 'Special Education and Clinical Sciences, University of Oregon.'}, {'ForeName': 'María Reina', 'Initials': 'MR', 'LastName': 'Santiago-Rosario', 'Affiliation': 'Special Education and Clinical Sciences, University of Oregon.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Izzard', 'Affiliation': 'Special Education and Clinical Sciences, University of Oregon.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Austin', 'Affiliation': 'Special Education and Clinical Sciences, University of Oregon.'}, {'ForeName': 'Rhonda N T', 'Initials': 'RNT', 'LastName': 'Nese', 'Affiliation': 'Special Education and Clinical Sciences, University of Oregon.'}, {'ForeName': 'Tabathia S', 'Initials': 'TS', 'LastName': 'Baldy', 'Affiliation': 'Colquitt County Schools.'}]","School psychology (Washington, D.C.)",['10.1037/spq0000466']
3072,34766790,"Autonomic reactivity to social rejection, peer difficulties, and the buffering effects of adolescent friendships following early psychosocial deprivation.","Autonomic nervous system reactivity has been posited to be a mechanism contributing to social and emotional problems among children exposed to early adversity. Leveraging data from the Bucharest Early Intervention Project, a longitudinal randomized controlled trial of foster care versus institutional care of abandoned children in Romania, we assessed whether altered sympathetic reactivity to peer rejection feedback in early adolescence mediated the relation between early institutional rearing and peer problems in later adolescence. We also assessed whether adolescent friendship quality or randomized placement in foster care early in life moderated these associations. Participants include 68 institutionalized children randomized to care as usual, 68 institutionalized children randomized to foster care, and 135 never-institutionalized children. At age 12, participants reported friendship quality with respect to a best friend and completed a social rejection task while electrocardiogram and impedance cardiography were recorded. Sympathetic nervous system reactivity to rejection feedback was assessed using preejection period (PEP). At ages 12 and 16, peer problems were reported by parents. Mediation analysis revealed that less PEP reactivity to social rejection at age 12 partially mediated the association between early institutionalization and greater peer problems at age 16. Further moderated mediation analysis revealed that this indirect effect was evidenced among previously institutionalized youths with low, but not high, quality friendships. We did not observe foster care intervention effects. These findings suggest that altered sympathetic reactivity to social rejection might be a mechanism linking early institutionalization to social difficulties into adolescence, however, positive adolescent friendships may buffer these effects. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,We did not observe foster care intervention effects.,"['Participants include 68 institutionalized children randomized to care as usual, 68 institutionalized children randomized to foster care, and 135 never-institutionalized children']",[],"['PEP reactivity to social rejection', 'social rejection task while electrocardiogram and impedance cardiography', 'adolescent friendship quality', 'friendship quality']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008099', 'cui_str': 'Institutionalized Child'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0237827', 'cui_str': 'Social exclusion'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0007185', 'cui_str': 'Impedance Cardiography'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",68.0,0.0223038,We did not observe foster care intervention effects.,"[{'ForeName': 'Alva', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Department of Human Development and Quantitative Methodology.'}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'McLaughlin', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Sheridan', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Boston Children's Hospital.""}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0001016']
3073,34766787,Cross-cultural comparisons of the effect of a schizophrenia label on stigmatizing family attitudes: A case vignette study.,"It has been proposed that stigmatizing attitudes toward a family member with schizophrenia are less prevalent in low- and middle-income countries (LAMIC) than in high-income countries (HIC). Furthermore, studies from HIC have shown that labeling increases certain aspects of stigma. This raises concerns about an export of this Western psychiatric labeling practice to LAMIC. The aim of the present research was to determine (a) whether stigmatizing family attitudes are less prevalent in LAMIC than in HIC and (b) whether stigmatizing family attitudes are intensified in both country types by introducing a schizophrenia label. Adults from two HIC ( n  = 718) and four LAMIC ( n  = 763) participated in the online study by reading a vignette, which depicted a family member presenting schizophrenia symptoms. Participants were randomly allocated to receive either the label (mental illness called schizophrenia) or the no label condition. Stigma-related stereotypes, emotions, and negative family affect were measured. A two-way multivariate analysis of covariance was conducted. This analysis revealed that participants from LAMIC showed significantly less stigmatizing attitudes toward their family members compared to those from HIC. Introducing a schizophrenia label significantly increased stigmatizing family attitudes in both country types, but the association between labeling and family attitudes was stronger in HIC than in LAMIC. Our results indicate that family attitudes toward schizophrenia and associated labeling effects differ between countries with varying economic strata and cultural values. This needs to be considered in stigma research and in the tailoring of antistigma interventions. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Introducing a schizophrenia label significantly increased stigmatizing family attitudes in both country types, but the association between labeling and family attitudes was stronger in HIC than in LAMIC.","['stigmatizing family attitudes', 'Adults from two HIC ( n  = 718) and four LAMIC ( n  = 763) participated in the online study by reading a vignette, which depicted a family member presenting schizophrenia symptoms']","['schizophrenia label', 'label (mental illness called schizophrenia) or the no label condition']","['stigmatizing attitudes', 'stigmatizing family attitudes', 'Stigma-related stereotypes, emotions, and negative family affect']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",,0.0447238,"Introducing a schizophrenia label significantly increased stigmatizing family attitudes in both country types, but the association between labeling and family attitudes was stronger in HIC than in LAMIC.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wüsten', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Tania M', 'Initials': 'TM', 'LastName': 'Lincoln', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}]",Journal of abnormal psychology,['10.1037/abn0000708']
3074,34769711,Men Show Reduced Cardiac Baroreceptor Sensitivity during Modestly Painful Electrical Stimulation of the Forearm: Exploratory Results from a Sham-Controlled Crossover Vagus Nerve Stimulation Study.,"This paper presents data from a transcutaneous vagus nerve stimulation experiment that point towards a blunted cardiac baroreceptor sensitivity (cBRS) in young males compared to females during electrical stimulation of the forearm and a rhythmic breathing task. Continuous electrocardiography, impedance cardiography and continuous blood-pressure recordings were assessed in a sex-matched cohort of twenty young healthy subjects. Electrical stimulation of the median nerve was conducted by using a threshold-tracking method combined with two rhythmic breathing tasks (0.1 and 0.2 Hz) before, during and after active or sham transcutaneous vagus nerve stimulation. Autonomic and hemodynamic parameters were calculated, and differences were analyzed by using linear mixed models and post hoc F-tests. None of the autonomic and hemodynamic parameters differed between the sham and active conditions. However, compared to females, male participants had an overall lower total cBRS independent of stimulation condition during nerve stimulation (females: 14.96 ± 5.67 ms/mmHg, males: 11.89 ± 3.24 ms/mmHg,  p  = 0.031) and rhythmic breathing at 0.2 Hz (females: 21.49 ± 8.47 ms/mmHg, males: 15.12 ± 5.70 ms/mmHg,  p  = 0.004). Whereas vagus nerve stimulation at the left inner tragus did not affect the efferent vagal control of the heart, we found similar patterns of baroreceptor sensitivity activation over the stimulation period in both sexes, which, however, significantly differed in their magnitude, with females showing an overall higher cBRS.",2021,None of the autonomic and hemodynamic parameters differed between the sham and active conditions.,"['young males', 'twenty young healthy subjects']","['threshold-tracking method combined with two rhythmic breathing tasks', 'Continuous electrocardiography, impedance cardiography and continuous blood-pressure recordings']","['Autonomic and hemodynamic parameters', 'total cBRS', 'Cardiac Baroreceptor Sensitivity', 'cardiac baroreceptor sensitivity (cBRS', 'rhythmic breathing', 'autonomic and hemodynamic parameters', 'baroreceptor sensitivity activation']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0007185', 'cui_str': 'Impedance Cardiography'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033093', 'cui_str': 'Baroreceptors'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",20.0,0.0187472,None of the autonomic and hemodynamic parameters differed between the sham and active conditions.,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Veiz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, University of Göttingen, 37075 Göttingen, Germany.'}, {'ForeName': 'Susann-Kristin', 'Initials': 'SK', 'LastName': 'Kieslich', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, University of Göttingen, 37075 Göttingen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Staab', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, University of Göttingen, 37075 Göttingen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Czesnik', 'Affiliation': 'Department of Neurology, University Medical Center, University of Göttingen, 37075 Göttingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Herrmann-Lingen', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, University of Göttingen, 37075 Göttingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, University of Göttingen, 37075 Göttingen, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph182111193']
3075,34769707,Implementation of a WeChat-Based Smoking Cessation Program for Chinese Smokers.,"Introduction:  Although smoking prevalence has recently declined, the smoking prevalence in China remains high. Extensive research has demonstrated ways that social media can assist in quitting smoking. WeChat is the most commonly used social media platform in China but has not been used for smoking cessation. A process evaluation of a novel WeChat-based smoking cessation intervention was conducted to measure its efficacy of content delivery, participant satisfaction, engagement, and likelihood of recommendation to others.  Methods:  A three-week, three-arm, single-blind randomized control trial was established. WeChat was used to recruit 403 participants and to deliver intervention messages and process evaluation surveys to them. Recruitment advertisements were posted on an official WeChat account and were forwarded to WeChat Moments. Intervention messages were delivered once a day during weekdays, using the WeChat broadcasting messages function, with two messages being sent each time. Process evaluation surveys were organized using Wenjuanwang and were delivered via WeChat. Process assessments were conducted every Friday to assess intervention message receipt, satisfaction level, engagement level, and recommendation to others. The receipt of intervention messages was measured by a self-reported question indicating which messages were read each week. Satisfaction was measured by a five-item Likert scale survey. Engagement was measured by a one-item Likert scale survey. Recommendation to others was measured by one self-reported question.  Results:  Participants read an average of 4.76 (out of 10), 5.80 (out of 10), and 4.25 (out of 6) messages at week 1, week 2, and week 3, respectively. The second messages were less likely to be read compared to the first messages (52.3% vs. 61.6%, respectively). Moreover, within each single week, the number of participants who read the intervention messages gradually decreases over time. Picture-based intervention messages tended to be less likely to be read than video-based intervention messages. Total program satisfaction scores ranged between 5 and 25, and the overall scores for satisfaction for each week were 21.55, 22.27, and 22.76, respectively. No significant differences were found in all the satisfaction indicators between groups. More than 60% of participants reported being either highly engaged or somewhat engaged each week. In addition, most participants (93.0% at week 1, 95.8% at week 2, and 96.2% at week 3) reported that they were willing to recommend our program to others.  Discussion:  A WeChat-based smoking cessation intervention for Chinese smokers was implemented and evaluated. For future studies, one should consider sending messages of a higher importance as the first message of a given day. Smokers had a higher rate of reading intervention messages at the beginning part of each week, during which, relatively important messages should be prioritized. One might also consider alternating the topics and formats of the messages for a better engagement of the users in future studies.",2021,No significant differences were found in all the satisfaction indicators between groups.,"['Chinese Smokers', 'Chinese smokers']","['WeChat-based smoking cessation intervention', 'WeChat', 'novel WeChat-based smoking cessation intervention', 'WeChat-Based Smoking Cessation Program']","['satisfaction indicators', 'Satisfaction', 'rate of reading intervention messages', 'Total program satisfaction scores', 'efficacy of content delivery, participant satisfaction, engagement, and likelihood of recommendation to others', 'satisfaction level, engagement level, and recommendation to others']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",403.0,0.0203051,No significant differences were found in all the satisfaction indicators between groups.,"[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Luo', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, CA 92122, USA.'}, {'ForeName': 'Mirandy S', 'Initials': 'MS', 'LastName': 'Li', 'Affiliation': 'Behavioral and Community Health Sciences, School of Public Health, Louisiana State University Health Sciences Center-New Orleans, New Orleans, LA 70122, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'Behavioral and Community Health Sciences, School of Public Health, Louisiana State University Health Sciences Center-New Orleans, New Orleans, LA 70122, USA.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Fritz', 'Affiliation': 'Behavioral and Community Health Sciences, School of Public Health, Louisiana State University Health Sciences Center-New Orleans, New Orleans, LA 70122, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Phillippi', 'Affiliation': 'Behavioral and Community Health Sciences, School of Public Health, Louisiana State University Health Sciences Center-New Orleans, New Orleans, LA 70122, USA.'}, {'ForeName': 'Qingzhao', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Biostatistics, School of Public Health, Louisiana State University Health Sciences Center-New Orleans, New Orleans, LA 70122, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kantrow', 'Affiliation': 'School of Medicine, Louisiana State University Health Sciences Center-New Orleans, New Orleans, LA 70122, USA.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA 900095, USA.'}, {'ForeName': 'Yongchun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Clinical Nutrition, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Zhengzhou 450003, China.""}, {'ForeName': 'Kaylin', 'Initials': 'K', 'LastName': 'Beiter', 'Affiliation': 'Behavioral and Community Health Sciences, School of Public Health, Louisiana State University Health Sciences Center-New Orleans, New Orleans, LA 70122, USA.'}, {'ForeName': 'Tung-Sung', 'Initials': 'TS', 'LastName': 'Tseng', 'Affiliation': 'Behavioral and Community Health Sciences, School of Public Health, Louisiana State University Health Sciences Center-New Orleans, New Orleans, LA 70122, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph182111189']
3076,34769704,Acute Effects of Vibration Foam Rolling with Light and Moderate Pressure on Blood Pressure and Senior Fitness Test in Older Women.,"Vibration foam rolling (VR) can improve flexibility and sports performance. However, blood pressure (BP), heart rate (HR) and senior fitness test (SFT) responses induced by an acute VR session in older women are currently unknown. Fifteen healthy women (72.90 ± 4.32 years) completed three separated randomly sequenced experimental visits. During each visit, they started with a warm-up protocol (general warm up (GW): walking + static stretching (SS), SS + VR with light pressure (VRL), or SS + VR with moderate pressure (VRM)), and completed BP, HR, SFT measurements. The systolic BP increased significantly after all three warm up protocols ( p  < 0.05). Both VRL and VRM protocols induced statistically significant improvements (effect size range: 0.3-1.04,  p  < 0.05) in the senior fitness test (back scratch, 30 s chair stand, 30 s arm curl, and 8 foot up and go), as compared to the GW. In addition, the VRM showed greater improvement for the 2 min step test when comparing with the VRL. Therefore, including VR in a warm-up protocol can result in superior SFT performance enhancement than the GW does in healthy older women.",2021,"Both VRL and VRM protocols induced statistically significant improvements (effect size range: 0.3-1.04,  p  < 0.05) in the senior fitness test (back scratch, 30 s chair stand, 30 s arm curl, and 8 foot up and go), as compared to the GW.","['Older Women', 'Fifteen healthy women (72.90 ± 4.32 years', 'healthy older women']","['Vibration Foam Rolling with Light and Moderate Pressure', 'Vibration foam rolling (VR', 'warm-up protocol (general warm up (GW): walking + static stretching (SS), SS + VR with light pressure (VRL), or SS + VR with moderate pressure (VRM']","['flexibility and sports performance', 'systolic BP', 'Blood Pressure and Senior Fitness Test', 'blood pressure (BP), heart rate (HR) and senior fitness test (SFT) responses']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517760', 'cui_str': '4.32'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",15.0,0.0279605,"Both VRL and VRM protocols induced statistically significant improvements (effect size range: 0.3-1.04,  p  < 0.05) in the senior fitness test (back scratch, 30 s chair stand, 30 s arm curl, and 8 foot up and go), as compared to the GW.","[{'ForeName': 'Wen-Chieh', 'Initials': 'WC', 'LastName': 'Yang', 'Affiliation': 'Department of Physical Therapy, Hung Kuang University, Taichung 433304, Taiwan.'}, {'ForeName': 'Che-Hsiu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Sport Performance, National Taiwan University of Sport, Taichung 404401, Taiwan.'}, {'ForeName': 'Lee-Ping', 'Initials': 'LP', 'LastName': 'Chu', 'Affiliation': 'Department of Orthopedics, China Medical University Hospital, Taichung 404333, Taiwan.'}, {'ForeName': 'Chih-Hui', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': 'Department of Exercise Health Science, National Taiwan University of Sport, Taichung 404401, Taiwan.'}, {'ForeName': 'Chin-Hsien', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Department of Leisure Industry Management, National Chin-Yi University of Technology, Taichung 411030, Taiwan.'}, {'ForeName': 'Kai-Wei', 'Initials': 'KW', 'LastName': 'Yu', 'Affiliation': 'Department of Leisure Industry Management and Institute of Project Management, National Chin-Yi University of Technology, Taichung 411030, Taiwan.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Rehabilitation Sciences, University of Hartford, West Hartford, CT 06117, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph182111186']
3077,34770157,"The Comparison of the Effects between Continuous and Intermittent Energy Restriction in Short-Term Bodyweight Loss for Sedentary Population: A Randomized, Double-Blind, Controlled Trial.","OBJECTIVE


To compare the effects of continuous energy restriction (CER) and intermittent energy restriction (IER) in bodyweight loss plan in sedentary individuals with normal bodyweight and explore the influence factors of effect and individual retention.
METHODS


26 participants were recruited in this randomized controlled and double-blinded trial and allocated to CER and IER groups. Bodyweight (BW), body mass index (BMI), and resting metabolic rate (RMR) would be collected before and after a 4-week (28 days) plan which included energy restriction (CER or IER) and moderate-intensity exercise. Daily intake of three major nutrients (protein, carbohydrate, fat) and calories were recorded.
RESULTS


A significant decrease in BW and BMI were reported within each group. No statistically significant difference in the change of RMR in CERG. No statistically significant difference was reported in the effect between groups, neither as well the intake of total calories, three major nutrients, and individual plan retention. The influence factors of IER and CER are different.
CONCLUSION


Both CER and IER are effective and safe energy restriction strategies in the short term. Daily energy intake and physical exercise are important to both IER and CER.",2021,"No statistically significant difference was reported in the effect between groups, neither as well the intake of total calories, three major nutrients, and individual plan retention.","['26 participants', 'Sedentary Population', 'sedentary individuals with normal bodyweight']","['continuous energy restriction (CER) and intermittent energy restriction (IER', 'CER and IER', 'Continuous and Intermittent Energy Restriction']","['Bodyweight (BW), body mass index (BMI), and resting metabolic rate (RMR', 'energy restriction (CER or IER) and moderate-intensity exercise', 'BW and BMI', 'intake of total calories, three major nutrients, and individual plan retention', 'change of RMR in CERG']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",26.0,0.0496005,"No statistically significant difference was reported in the effect between groups, neither as well the intake of total calories, three major nutrients, and individual plan retention.","[{'ForeName': 'Manwen', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Yining', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Faculty of Sports Science, Ningbo University, Ningbo 315211, China.'}]",International journal of environmental research and public health,['10.3390/ijerph182111645']
3078,34767575,"Acceptability, effectiveness and cost-effectiveness of blended cognitive-behavioural therapy (bCBT) versus face-to-face CBT (ftfCBT) for anxiety disorders in specialised mental health care: A 15-week randomised controlled trial with 1-year follow-up.","BACKGROUND


Anxiety disorders are highly prevalent and cause substantial economic burden. Blended cognitive-behavioural therapy (bCBT), which integrates Internet-based CBT and face-to-face CBT (ftfCBT), is an attractive and potentially cost-saving treatment alternative to conventional CBT for patients with anxiety disorders in specialised mental health care. However, little is known about the effectiveness of bCBT in routine care. We examined the acceptability, effectiveness and cost-effectiveness of bCBT versus ftfCBT in outpatient specialised care to patients with panic disorder, social anxiety disorder and generalised anxiety disorder.
METHODS AND FINDINGS


Patients with anxiety disorders were randomised to bCBT (n = 52) or ftfCBT (n = 62). Acceptability of bCBT and ftfCBT were evaluated by assessing treatment preference, adherence, satisfaction and therapeutic alliance. Costs and effects were assessed at post-treatment and one-year follow-up. Primary outcome measure was the Beck Anxiety Inventory (BAI). Secondary outcomes were depressive symptoms, general psychopathology, work and social adjustment, quality of life and mastery. Incremental cost-effectiveness ratios (ICERs) were computed from societal and healthcare perspectives by calculating the incremental costs per incremental quality-adjusted life year (QALY). No significant differences between bCBT and ftfCBT were found on acceptability or effectiveness measures at post-treatment (Cohen's d between-group effect size on BAI = 0.15, 95% CI -0.30 to 0.60) or at one-year follow-up (d = -0.38, 95% CI -0.84 to 0.09). The modelled point estimates of societal costs (bCBT €10945, ftfCBT €10937) were higher and modelled point estimates of direct medical costs (bCBT €3748, ftfCBT €3841) were lower in bCBT. The acceptability curves showed that bCBT was expected to be a cost-effective intervention. Results should be carefully interpreted due to the small sample size.
CONCLUSIONS


bCBT appears an acceptable, clinically effective and potentially cost-saving alternative option for treating patients with anxiety disorders. Trials with larger samples are needed to further investigate cost-effectiveness.
TRIAL REGISTRATION


Netherlands Trial Register: NTR4912.",2021,"No significant differences between bCBT and ftfCBT were found on acceptability or effectiveness measures at post-treatment (Cohen's d between-group effect size on BAI = 0.15, 95% CI -0.30 to 0.60) or at one-year follow-up (d = -0.38, 95% CI -0.84 to 0.09).","['patients with anxiety disorders', 'Patients with anxiety disorders', 'outpatient specialised care to patients with panic disorder, social anxiety disorder and generalised anxiety disorder', 'anxiety disorders in specialised mental health care', 'patients with anxiety disorders in specialised mental health care']","['ftfCBT', 'bCBT and ftfCBT', 'blended cognitive-behavioural therapy (bCBT) versus face-to-face CBT (ftfCBT', 'Blended cognitive-behavioural therapy (bCBT), which integrates Internet-based CBT and face-to-face CBT (ftfCBT', 'bCBT']","['depressive symptoms, general psychopathology, work and social adjustment, quality of life and mastery', 'direct medical costs', 'Acceptability, effectiveness and cost-effectiveness', 'Beck Anxiety Inventory (BAI', 'Costs and effects', 'societal costs', 'acceptability or effectiveness measures', 'Incremental cost-effectiveness ratios (ICERs', 'treatment preference, adherence, satisfaction and therapeutic alliance', 'acceptability, effectiveness and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}]",,0.0268619,"No significant differences between bCBT and ftfCBT were found on acceptability or effectiveness measures at post-treatment (Cohen's d between-group effect size on BAI = 0.15, 95% CI -0.30 to 0.60) or at one-year follow-up (d = -0.38, 95% CI -0.84 to 0.09).","[{'ForeName': 'Geke', 'Initials': 'G', 'LastName': 'Romijn', 'Affiliation': 'Clinical Psychology Section, Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam; and Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Neeltje', 'Initials': 'N', 'LastName': 'Batelaan', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Psychiatry, Amsterdam Public Health Research Institute and GGZ inGeest Specialized Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Koning', 'Affiliation': 'Clinical Psychology Section, Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam; and Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'van Balkom', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Psychiatry, Amsterdam Public Health Research Institute and GGZ inGeest Specialized Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'de Leeuw', 'Affiliation': 'Altrecht Academic Anxiety Centre, Utrecht, Netherlands.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Benning', 'Affiliation': 'Department of Health Technology Assessment, Erasmus School of Health Policy and Management, Rotterdam, The Netherlands.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Hakkaart van Roijen', 'Affiliation': 'Department of Health Technology Assessment, Erasmus School of Health Policy and Management, Rotterdam, The Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Clinical Psychology Section, Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam; and Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0259493']
3079,34767574,"Mind training, stress and behaviour-A randomised experiment.","In this paper, we evaluate the effects of a psychological training, called Mindfulness-Based Stress Reduction (MBSR) on stress and risk and time preferences. MBSR is a well-known psychological technique, which is believed to improve self-control and reduce stress. We conduct the experiment with 139 participants, half of whom receive the MBSR training, while the other half are asked to watch a documentary series, both over 4 consecutive weeks. Using a range of self-reported and physiological measures (such as cortisol measures), we find evidence that mindfulness training reduces perceived stress, but we only find weak evidence of effects on risk and inter-temporal attitudes.",2021,"In this paper, we evaluate the effects of a psychological training, called Mindfulness-Based Stress Reduction (MBSR) on stress and risk and time preferences.","['139 participants, half of whom receive the MBSR training, while the other half are asked to watch a documentary series, both over 4 consecutive weeks']","['psychological training, called Mindfulness-Based Stress Reduction (MBSR']",['stress and risk and time preferences'],"[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]",139.0,0.0172033,"In this paper, we evaluate the effects of a psychological training, called Mindfulness-Based Stress Reduction (MBSR) on stress and risk and time preferences.","[{'ForeName': 'Yonas', 'Initials': 'Y', 'LastName': 'Alem', 'Affiliation': 'Department of Economics, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Behrendt', 'Affiliation': 'Behavioural Insights Team, London, United Kingdom.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Belot', 'Affiliation': 'Cornell University, Ithaca, NY, United States of America.'}, {'ForeName': 'Anikó', 'Initials': 'A', 'LastName': 'Bíró', 'Affiliation': 'Centre for Economic and Regional Studies, Békéscsaba, Hungary.'}]",PloS one,['10.1371/journal.pone.0258172']
3080,34767495,Efficacy of Inhaled Treprostinil on Multiple Disease Progression Events in Patients with Pulmonary Hypertension Due to Parenchymal Lung Disease in the INCREASE Trial.,"Rationale The INCREASE study of inhaled treprostinil met its primary endpoint of change in 6-minute walk distance at Week 16. In addition, there were significantly fewer clinical worsening events in patients receiving inhaled treprostinil. However, the incidence of multiple events in the same patient is unknown. Objectives This post-hoc analysis evaluated the effect of continued treatment with inhaled treprostinil on the frequency and impact of multiple disease progression events. Methods Patients enrolled in INCREASE were analyzed for disease progression events, defined as ≥15% decline in 6-minute walk distance, exacerbation of underlying lung disease, cardiopulmonary hospitalization, lung transplantation, ≥10% decline in forced vital capacity, or death during the duration of the 16-week study. Measurements and Main Results 147 disease progression events occurred in the inhaled treprostinil group (89/163 patients, 55%) compared to 215 events (109/163 patients, 67%) in the placebo group (p=0.018). There was a lower incidence of each disease progression component in the inhaled treprostinil group: 6-minute walk distance decline (45 vs. 64 events), lung disease exacerbation (48 vs. 72 events), forced vital capacity decline (19 vs. 33), cardiopulmonary hospitalization (23 vs. 33 events) and death (10 vs. 12). Fewer patients receiving inhaled treprostinil had multiple progression events compared to placebo (35 vs. 58; 22% vs. 36%, p=0.005). Conclusions Patients who received inhaled treprostinil were significantly less likely to experience further disease progression events after an initial event compared to placebo. These results support the continuation of inhaled treprostinil despite the occurrence of disease progression in clinical practice. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).",2021,"Fewer patients receiving inhaled treprostinil had multiple progression events compared to placebo (35 vs. 58; 22% vs. 36%, p=0.005).","['Patients with Pulmonary Hypertension Due to Parenchymal Lung Disease in the INCREASE Trial', 'patients receiving inhaled']","['Inhaled Treprostinil', 'placebo', 'treprostinil', 'inhaled treprostinil']","['6-minute walk distance, exacerbation of underlying lung disease, cardiopulmonary hospitalization, lung transplantation, ≥10% decline in forced vital capacity, or death', '6-minute walk distance', 'disease progression events', 'death', 'multiple progression events', 'cardiopulmonary hospitalization', 'lung disease exacerbation', '6-minute walk distance decline', 'forced vital capacity decline']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1145760', 'cui_str': 'Treprostinil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",,0.318855,"Fewer patients receiving inhaled treprostinil had multiple progression events compared to placebo (35 vs. 58; 22% vs. 36%, p=0.005).","[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': 'Inova Fairfax Hospital, 23146, Advanced Lung Disease and Transplant Program, Falls Church, Virginia, United States; steven.nathan@inova.org.'}, {'ForeName': 'Victor F', 'Initials': 'VF', 'LastName': 'Tapson', 'Affiliation': 'Cedars Sinai Medical Center, Medicine - Pulmonary, Beverely Hills, California, United States.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Elwing', 'Affiliation': 'University of Cincinnati, 2514, Pulmonary, Critical Care, and Sleep Medicine, Cincinnati, Ohio, United States.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Rischard', 'Affiliation': 'University of Arizona, Division of Pulmonary and Critical Care Medicine, Tuscon, Arizona, United States.'}, {'ForeName': 'Jinesh', 'Initials': 'J', 'LastName': 'Mehta', 'Affiliation': 'Cleveland Clinic Florida, Department of Pulmonary & Critical Care Medicine, Weston, Florida, United States.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Shapiro', 'Affiliation': 'UCLA Medical Center, 21767, Los Angeles, California, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Shen', 'Affiliation': 'United Therapeutics Corp, 17909, Silver Spring, Maryland, United States.'}, {'ForeName': 'Chunqin', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'United Therapeutics Corp, 17909, Silver Spring, Maryland, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'United Therapeutics Corp, 17909, Silver Spring, Maryland, United States.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Waxman', 'Affiliation': ""Brigham and Women's Hospital, 1861, Pulmonary and Critical Care, Boston, Massachusetts, United States.""}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202107-1766OC']
3081,34767488,Assessing the fidelity of the independently getting up off the floor (IGO) technique as part of the ReTrain pilot feasibility randomised controlled trial for stroke survivors.,"PURPOSE


Hemiparesis and physical deconditioning following stroke lead to an increase in falls, which many individuals cannot get up from. Teaching stroke survivors to independently get off the floor (IGO) might mitigate long-lie complications. IGO was taught as part of a community-based, functional rehabilitation training programme (ReTrain). We explore the feasibility of teaching IGO and assess participant's level of mastery, adherence, and injury risk.
MATERIALS AND METHODS


Videos of participants ( n  = 17) performing IGO at early, middle, and late stages of the ReTrain programme were compared to a manualised standard. A visual, qualitative analysis was used to assess technique mastery, adherence, and injury risk.
RESULTS


Most participants (64%) achieved independent, safe practice of IGO. A good (73%) level of adherence to IGO and low incidence of risk of injury (6.8%) were observed. Deviations were made to accommodate for non-stroke related comorbidities.
CONCLUSIONS


IGO was successfully and safely practised by stroke survivors including those with hemiparesis. Trainers should be aware of comorbidities that may impede completion of IGO and modify teaching to accommodate individual need. Further research should assess if IGO can be utilised by individuals who have other disabilities with unilateral impairments and whether IGO has physical, functional and economic benefit.Implications for rehabilitationFalls are common in stroke survivors, and many are unable to get up despite being uninjured, leading to long-lie complications or ambulance call-outs but non-conveyance to hospital.Teaching the independently getting up off the floor (IGO) technique to stroke survivors was possible for those with or without hemiparesis, and remained safe despite modifications to accommodate an individual's needs.Individual assessment is needed to check if a stroke survivor is suitable for learning IGO including, but not limited to, their ability to safely get to the floor and to temporarily stand (without support) at the end of the technique.",2021,"Teaching the independently getting up off the floor (IGO) technique to stroke survivors was possible for those with or without hemiparesis, and remained safe despite modifications to accommodate an individual's needs.","['stroke survivors', 'individuals who have other disabilities with unilateral impairments', 'Videos of participants ( n \u2009=\u200917) performing IGO at early, middle, and']",['functional rehabilitation training programme (ReTrain'],"['mastery, adherence, and injury risk', 'level of adherence to IGO and low incidence of risk of injury', 'technique mastery, adherence, and injury risk', 'safe practice of IGO']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}]","[{'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0582456', 'cui_str': 'At risk for injury'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.107339,"Teaching the independently getting up off the floor (IGO) technique to stroke survivors was possible for those with or without hemiparesis, and remained safe despite modifications to accommodate an individual's needs.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hollands', 'Affiliation': 'University of Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Raff', 'Initials': 'R', 'LastName': 'Calitri', 'Affiliation': 'University of Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Warmoth', 'Affiliation': 'Research in Public Health and Community Care (CRIPACC), University of Hertfordshire, Hatfield, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Shepherd', 'Affiliation': 'School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Allison', 'Affiliation': 'Torbay & South Devon NHS Foundation Trust, Torquay, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dean', 'Affiliation': 'University of Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Disability and rehabilitation,['10.1080/09638288.2021.1998672']
3082,34767481,Impact of Behavioral Nudges on the Quality of Serious Illness Conversations Among Patients With Cancer: Secondary Analysis of a Randomized Controlled Trial.,"PURPOSE


Serious Illness Conversations (SICs) are structured conversations between clinicians and patients about prognosis, treatment goals, and end-of-life preferences. Although behavioral interventions may prompt earlier or more frequent SICs, their impact on the quality of SICs is unclear.
METHODS


This was a secondary analysis of a randomized clinical trial (NCT03984773) among 78 clinicians and 14,607 patients with cancer testing the impact of an automated mortality prediction with behavioral nudges to clinicians to prompt more SICs. We analyzed 318 randomly selected SICs matched 1:1 by clinicians (159 control and 159 intervention) to compare the quality of intervention vs. control conversations using a validated codebook. Comprehensiveness of SIC documentation was used as a measure of quality, with higher integer numbers of documented conversation domains corresponding to higher quality conversations. A conversation was classified as high-quality if its score was ≥ 8 of a maximum of 10. Using a noninferiority design, mixed effects regression models with clinician-level random effects were used to assess SIC quality in intervention vs. control groups, concluding noninferiority if the adjusted odds ratio (aOR) was not significantly < 0.9.
RESULTS


Baseline characteristics of the control and intervention groups were similar. Intervention SICs were noninferior to control conversations (aOR 0.99; 95% CI, 0.91 to 1.09). The intervention increased the likelihood of addressing patient-clinician relationship (aOR = 1.99; 95% CI, 1.23 to 3.27;  P  < .01) and decreased the likelihood of addressing family involvement (aOR = 0.56; 95% CI, 0.34 to 0.90;  P  < .05).
CONCLUSION


A behavioral intervention that increased SIC frequency did not decrease their quality. Behavioral prompts may increase SIC frequency without sacrificing quality.",2021,"Intervention SICs were noninferior to control conversations (aOR 0.99; 95% CI, 0.91 to 1.09).","['318 randomly selected SICs matched 1:1 by clinicians (159 control and 159 intervention', '78 clinicians and 14,607 patients with cancer testing the impact of an automated mortality prediction with behavioral nudges to clinicians to prompt more SICs', 'Patients With Cancer']",['Behavioral Nudges'],"['Quality of Serious Illness Conversations', 'likelihood of addressing patient-clinician relationship', 'likelihood of addressing family involvement', 'SIC frequency', 'SIC quality']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",318.0,0.116758,"Intervention SICs were noninferior to control conversations (aOR 0.99; 95% CI, 0.91 to 1.09).","[{'ForeName': 'Eric H', 'Initials': 'EH', 'LastName': 'Li', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ferrell', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Klaiman', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': ""O'Connor"", 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Schuchter', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jinbo', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Manz', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Ravi B', 'Initials': 'RB', 'LastName': 'Parikh', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}]",JCO oncology practice,['10.1200/OP.21.00024']
3083,34767474,"Effects of an Oncology Nurse-Led, Primary Palliative Care Intervention (CONNECT) on Illness Expectations Among Patients With Advanced Cancer.","PURPOSE


Patients with advanced cancer often have unrealistic expectations about prognosis and treatment. This study assessed the effect of an oncology nurse-led primary palliative care intervention on illness expectations among patients with advanced cancer.
METHODS


This study is a secondary analysis of a cluster-randomized trial of primary palliative care conducted at 17 oncology clinics. Adult patients with advanced solid tumors for whom the oncologist would not be surprised if died within 1 year were enrolled. Monthly visits were designed to foster realistic illness expectations by eliciting patient concerns and goals for their medical care and empowering patients and families to engage in discussions with oncologists about treatment options and preferences. Baseline and 3-month questionnaires included questions about life expectancy, treatment intent, and terminal illness acknowledgment. Odds of realistic illness expectations at 3 months were adjusted for baseline responses, patient demographic and clinical characteristics, and intervention dose.
RESULTS


Among 457 primarily White patients, there was little difference in realistic illness expectations at 3 months between intervention and standard care groups: 12.8%  v  11.4% for life expectancy (adjusted odds ratio [aOR] = 1.15; 95% CI, 0.59 to 2.22;  P  = .684); 24.6%  v  33.3% for treatment intent (aOR = 0.76; 95% CI, 0.44 to 1.27;  P  = .290); 53.6%  v  44.7% for terminal illness acknowledgment (aOR = 1.28; 95% CI, 0.81 to 2.00;  P  = .288). Results did not differ when accounting for variation in clinic sites or intervention dose.
CONCLUSION


Illness expectations are difficult to change among patients with advanced cancer. Additional work is needed to identify approaches within oncology practices that foster realistic illness expectations to improve patient decision making.",2021,"Among 457 primarily White patients, there was little difference in realistic illness expectations at 3 months between intervention and standard care groups: 12.8%  v  11.4% for life expectancy (adjusted odds ratio [aOR] = 1.15; 95% CI, 0.59 to 2.22;  P  = .684); 24.6%  v  33.3% for treatment intent (aOR = 0.76; 95% CI, 0.44 to 1.27;  P  = .290); 53.6%  v  44.7% for terminal illness acknowledgment (aOR = 1.28; 95% CI, 0.81 to 2.00;  P  = .288).","['Patients with advanced cancer', '457 primarily White patients', 'primary palliative care conducted at 17 oncology clinics', 'Patients With Advanced Cancer', 'Adult patients with advanced solid tumors for whom the oncologist would not be surprised if died within 1 year were enrolled', 'patients with advanced cancer']","['oncology nurse-led primary palliative care intervention', 'Oncology Nurse-Led, Primary Palliative Care Intervention (CONNECT']","['realistic illness expectations', 'questions about life expectancy, treatment intent, and terminal illness acknowledgment', 'life expectancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0104487', 'cui_str': 'AT 17'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0557529', 'cui_str': 'Oncology nurse'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0679247', 'cui_str': 'Terminal illness'}]",457.0,0.196665,"Among 457 primarily White patients, there was little difference in realistic illness expectations at 3 months between intervention and standard care groups: 12.8%  v  11.4% for life expectancy (adjusted odds ratio [aOR] = 1.15; 95% CI, 0.59 to 2.22;  P  = .684); 24.6%  v  33.3% for treatment intent (aOR = 0.76; 95% CI, 0.44 to 1.27;  P  = .290); 53.6%  v  44.7% for terminal illness acknowledgment (aOR = 1.28; 95% CI, 0.81 to 2.00;  P  = .288).","[{'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Sigler', 'Affiliation': 'Division of General Internal Medicine, Section of Palliative Care and Medical Ethics, Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Althouse', 'Affiliation': 'Division of General Internal Medicine, Section of Palliative Care and Medical Ethics, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Teresa H', 'Initials': 'TH', 'LastName': 'Thomas', 'Affiliation': 'Division of General Internal Medicine, Section of Palliative Care and Medical Ethics, Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Division of General Internal Medicine, Section of Palliative Care and Medical Ethics, Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Division of General Internal Medicine, Section of Palliative Care and Medical Ethics, Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Division of General Internal Medicine, Section of Palliative Medicine, Johns Hopkins University School of Medicine and Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chu', 'Affiliation': 'Albert Einstein Cancer Center, Albert Einstein College of Medicine, New York, NY.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rosenzweig', 'Affiliation': 'Division of General Internal Medicine, Section of Palliative Care and Medical Ethics, Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Smith', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': 'Division of General Internal Medicine, Section of Palliative Care and Medical Ethics, Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, PA.'}]",JCO oncology practice,['10.1200/OP.21.00573']
3084,34767764,"Tofacitinib in juvenile idiopathic arthritis: a double-blind, placebo-controlled, withdrawal phase 3 randomised trial.","BACKGROUND


Tofacitinib is an oral Janus kinase inhibitor. This trial assessed the efficacy and safety of tofacitinib versus placebo in patients with polyarticular course juvenile idiopathic arthritis (JIA).
METHODS


This double-blind, withdrawal phase 3 trial enrolled patients with polyarticular course JIA (extended oligoarthritis, rheumatoid factor-positive or rheumatoid factor-negative polyarthritis, or systemic JIA without active systemic features) aged 2 years to younger than 18 years, and was done at 64 centres of the Paediatric Rheumatology International Trials Organisation and Pediatric Rheumatology Collaborative Study Group networks in 14 countries. Patients with psoriatic arthritis or enthesitis-related arthritis were enrolled for exploratory endpoints. During part 1 of the study, patients received oral open-label tofacitinib (weight-based doses; 5 mg twice daily or lower) for 18 weeks. Patients achieving at least JIA/American College of Rheumatology 30 response were randomly assigned (1:1) using an Interactive Response Technology system to continue tofacitinib or switch to placebo in part 2 of the study for 26 weeks. The primary endpoint was JIA flare rate by week 44 in part 2 in patients with polyarticular course JIA; the intention-to-treat principle was applied. Safety was evaluated throughout part 1 and part 2 of the study in all patients who received one dose or more of study medication. This trial is registered with ClinicalTrials.gov, NCT02592434.
FINDINGS


Between June 10, 2016, and May 16, 2019, of 225 patients enrolled, 184 (82%) patients had polyarticular course JIA, 20 (9%) had psoriatic arthritis, and 21 (9%) had enthesitis-related arthritis. 147 (65%) of 225 patients received concomitant methotrexate. In part 2, 142 patients with polyarticular course JIA were assigned to tofacitinib (n=72) or placebo (n=70). Flare rate by week 44 was significantly lower with tofacitinib (21 [29%] of 72 patients) than with placebo (37 [53%] of 70 patients; hazard ratio 0·46, 95% CI 0·27-0·79; p=0·0031). In part 2 of the study, adverse events occurred in 68 (77%) of 88 patients receiving tofacitinib and 63 (74%) of 85 in the placebo group. Serious adverse events occurred in one (1%) and two (2%), respectively. In the entire tofacitinib exposure period, 107 (48%) of 225 patients had infections or infestations. There were no deaths during this study.
INTERPRETATION


The results of this pivotal trial show that tofacitinib is an effective treatment in patients with polyarticular course JIA. New oral therapies are particularly relevant for children and adolescents, who might prefer to avoid injections.
FUNDING


Pfizer.",2021,"Flare rate by week 44 was significantly lower with tofacitinib (21 [29%] of 72 patients) than with placebo (37 [53%] of 70 patients; hazard ratio 0·46, 95% CI 0·27-0·79; p=0·0031).","['patients with polyarticular course juvenile idiopathic arthritis (JIA', 'Patients achieving at least JIA/American College of Rheumatology 30 response', '142 patients with polyarticular course JIA', 'juvenile idiopathic arthritis', 'patients had polyarticular course JIA, 20 (9%) had psoriatic arthritis, and 21 (9%) had enthesitis-related arthritis', 'enrolled patients with polyarticular course JIA (extended oligoarthritis, rheumatoid factor-positive or rheumatoid factor-negative polyarthritis, or systemic JIA without active systemic features) aged 2 years to younger than 18 years, and was done at 64 centres of the Paediatric Rheumatology International Trials Organisation and Pediatric Rheumatology Collaborative Study Group networks in 14 countries', 'Patients with psoriatic arthritis or enthesitis-related arthritis', '225 patients had infections or infestations', 'children and adolescents', 'patients with polyarticular course JIA', 'Between June 10, 2016, and May 16, 2019, of 225 patients enrolled, 184 (82']","['concomitant methotrexate', 'Tofacitinib', 'Interactive Response Technology system to continue tofacitinib or switch to placebo', 'tofacitinib', 'oral open-label tofacitinib', 'placebo']","['Serious adverse events', 'adverse events', 'JIA flare rate', 'Safety', 'efficacy and safety', 'Flare rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0240789', 'cui_str': 'Polyarticular'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C3892044', 'cui_str': 'Oligoarthritis'}, {'cui': 'C0151379', 'cui_str': 'Rheumatoid factor positive'}, {'cui': 'C2931825', 'cui_str': 'Negative rheumatoid factor polyarthritis'}, {'cui': 'C1384600', 'cui_str': 'Systemic onset juvenile chronic arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1621271', 'cui_str': 'Pediatric rheumatology'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0030499', 'cui_str': 'Disease caused by parasite'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517616', 'cui_str': '184'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3495922', 'cui_str': 'Juvenile idiopathic arthritis flare'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",225.0,0.645335,"Flare rate by week 44 was significantly lower with tofacitinib (21 [29%] of 72 patients) than with placebo (37 [53%] of 70 patients; hazard ratio 0·46, 95% CI 0·27-0·79; p=0·0031).","[{'ForeName': 'Nicolino', 'Initials': 'N', 'LastName': 'Ruperto', 'Affiliation': 'IRCCS Istituto Giannina Gaslini, UOSID Centro Trial, PRINTO, Genova, Italy. Electronic address: nicolaruperto@gaslini.org.'}, {'ForeName': 'Hermine I', 'Initials': 'HI', 'LastName': 'Brunner', 'Affiliation': ""College of Medicine, University of Cincinnati, and Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Synoverska', 'Affiliation': ""Regional Children's Hospital, Ivano-Frankivsk, Ukraine.""}, {'ForeName': 'Tracy V', 'Initials': 'TV', 'LastName': 'Ting', 'Affiliation': ""College of Medicine, University of Cincinnati, and Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Carlos Abud', 'Initials': 'CA', 'LastName': 'Mendoza', 'Affiliation': 'Regional Unit of Rheumatology and Osteoporosis at Central Hospital, Faculty of Medicine, San Luis Potosí, Mexico.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Spindler', 'Affiliation': 'Centro Médico Privado de Reumatologia, Tucumán, Argentina.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Vyzhga', 'Affiliation': 'Vinnytsya National Medical University N Pirogov, Vinnytsya, Ukraine.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Marzan', 'Affiliation': ""Division of Rheumatology, Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}, {'ForeName': 'Lyudmila', 'Initials': 'L', 'LastName': 'Grebenkina', 'Affiliation': 'Togliatti City Clinical Hospital number 5, Togliatti, Russia.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Tirosh', 'Affiliation': ""Pediatric Rheumatology Unit and Department of Pediatrics, Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Tel-Hashomer, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Imundo', 'Affiliation': 'Adolescent Rheumatology Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Jerath', 'Affiliation': 'Augusta University Medical Center, Augusta, GA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Kingsbury', 'Affiliation': ""Augusta University Medical Center, Augusta, GA, USA; Randall Children's Hospital at Legacy Emanuel, Portland, OR, USA.""}, {'ForeName': 'Betul', 'Initials': 'B', 'LastName': 'Sozeri', 'Affiliation': 'Department of Pediatric Rheumatology, Ümraniye Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sheetal S', 'Initials': 'SS', 'LastName': 'Vora', 'Affiliation': ""Pediatric Rheumatology, Atrium Health Levine Children's Hospital, Charlotte, NC, USA.""}, {'ForeName': 'Sampath', 'Initials': 'S', 'LastName': 'Prahalad', 'Affiliation': ""Departments of Pediatrics and Human Genetics, Emory University School of Medicine, and Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zholobova', 'Affiliation': ""Institute of Children's Health, University Children's Clinical Hospital, Sechenov University, Moscow, Russia.""}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Butbul Aviel', 'Affiliation': ""Pediatric Rheumatology Service, Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel.""}, {'ForeName': 'Vyacheslav', 'Initials': 'V', 'LastName': 'Chasnyk', 'Affiliation': 'Saint Petersburg State Pediatric Medical University, Saint-Petersburg, Russia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Lerman', 'Affiliation': ""Division of Rheumatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Kabita', 'Initials': 'K', 'LastName': 'Nanda', 'Affiliation': ""Division of Rheumatology, Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Heinrike', 'Initials': 'H', 'LastName': 'Schmeling', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Tory', 'Affiliation': ""Division of Rheumatology, Connecticut Children's Medical Center, Hartford, and Department of Pediatrics, University of Connecticut School of Medicine, Farmington, CT, USA.""}, {'ForeName': 'Yosef', 'Initials': 'Y', 'LastName': 'Uziel', 'Affiliation': 'Pediatric Rheumatology Unit, Department of Pediatrics, Meir Medical Centre, Kfar Saba, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Diego O', 'Initials': 'DO', 'LastName': 'Viola', 'Affiliation': 'CAICI Institute, Rosario City, Argentina.'}, {'ForeName': 'Holly B', 'Initials': 'HB', 'LastName': 'Posner', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Kanik', 'Affiliation': 'Pfizer, Groton, CT, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Wouters', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Pfizer, Groton, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Lazariciu', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Ming-Ann', 'Initials': 'MA', 'LastName': 'Hsu', 'Affiliation': 'Pfizer, Groton, CT, USA.'}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Suehiro', 'Affiliation': 'Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'Università degli Studi di Genova, Genova, Italy.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lovell', 'Affiliation': ""College of Medicine, University of Cincinnati, and Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)01255-1']
3085,34767729,Implementing Prevention Plus with Underserved Families in an Integrated Primary Care Setting.,"Background:  This proof-of-concept trial examined a 6-month Prevention Plus (PP) intervention implemented in a federally qualified health center on child standardized BMI (ZBMI), using a planned clinical effect threshold of -0.16 ZBMI. The relationship between food security status and PP delivered with caregiver goals (PP+) and without caregiver goals (PP-) on energy balance behaviors ( i.e. , fruits and vegetables, physical activity) and child ZBMI was explored.  Methods:  Seventy-three, underserved children, 4-10 years of age with a BMI ≥85th percentile, were randomized to one of two interventions, PP+ and PP-, both providing 2.5 hours of contact time, implemented in five clinics by behavioral health consultants (BHCs). Outcomes were child anthropometrics (included 9-month follow-up), implementation data collected from electronic health records, and caregiver and BHC evaluations.  Results:  Children were 57.5% female and 78.1% Hispanic, with 32.9% from food-insecure households and 58.9% from households with an annual income of less than $20,000. Child ZBMI significantly ( p  < 0.05) decreased at 6 and 9 months (-0.08 ± 0.24 and -0.12 ± 0.43), with only PP+ reaching the clinical threshold at 9 months (PP+: -0.20 ± 0.42 vs. PP-: -0.05 ± 0.42). Sixty-four percent of families attended ≥50% of the sessions, and BHCs delivered 78.5% ± 23.5% of components at attended sessions. Caregivers were satisfied with the intervention and BHCs found the intervention helpful/useful. No relationship with food insecurity status and outcomes was found.  Conclusions:  PP+ when delivered by a primary care provider to underserved families showed promise for producing a clinically meaningful effect. Families and providers felt the intervention was a viable treatment option.",2021,"Child ZBMI significantly ( p  < 0.05) decreased at 6 and 9 months (-0.08 ± 0.24 and -0.12 ± 0.43), with only PP+ reaching the clinical threshold at 9 months (PP+: -0.20 ± 0.42 vs. PP-: -0.05 ± 0.42).","['federally qualified health center on child standardized BMI (ZBMI', 'Methods:  Seventy-three, underserved children, 4-10 years of age with a BMI ≥85th percentile', 'were 57.5% female and 78.1% Hispanic, with 32.9% from food-insecure households and 58.9% from households with an annual income of less than $20,000']","['Prevention Plus (PP) intervention', 'caregiver goals (PP+) and without caregiver goals (PP', 'PP+ and PP-, both providing 2.5 hours of contact time, implemented in five clinics by behavioral health consultants (BHCs']","['energy balance behaviors ( i.e. , fruits and vegetables, physical activity) and child ZBMI', 'Child ZBMI', 'child anthropometrics (included 9-month follow-up), implementation data collected from electronic health records, and caregiver and BHC evaluations']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0393584', 'cui_str': 'Benign hereditary chorea'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",,0.0463615,"Child ZBMI significantly ( p  < 0.05) decreased at 6 and 9 months (-0.08 ± 0.24 and -0.12 ± 0.43), with only PP+ reaching the clinical threshold at 9 months (PP+: -0.20 ± 0.42 vs. PP-: -0.05 ± 0.42).","[{'ForeName': 'Hollie A', 'Initials': 'HA', 'LastName': 'Raynor', 'Affiliation': 'Department of Nutrition, University of Tennessee Knoxville, Knoxville, TN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Propst', 'Affiliation': 'Cherokee Health Systems, Knoxville, TN, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Robson', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Kristoffer S', 'Initials': 'KS', 'LastName': 'Berlin', 'Affiliation': 'Department of Psychology, The University of Memphis, Memphis, TN, USA.'}, {'ForeName': 'Cristina S', 'Initials': 'CS', 'LastName': 'Barroso', 'Affiliation': 'Department of Public Health, University of Tennessee Knoxville, Knoxville, TN, USA.'}, {'ForeName': 'Parinda', 'Initials': 'P', 'LastName': 'Khatri', 'Affiliation': 'Cherokee Health Systems, Knoxville, TN, USA.'}]",Childhood obesity (Print),['10.1089/chi.2021.0071']
3086,34767728,How Do Interpersonal Relationships Affect Children's Weight Management? A Qualitative Analysis of Parents' Long-Term Perceptions after Obesity Treatment.,"Background:  Childhood obesity interventions are particularly effective during the preschool age, but little is known about parents' long-term perceptions of weight management. This study explores how parents perceive the influence of interpersonal relationships on their children's eating and physical activity 4 years after participating in a randomized controlled trial. Bronfenbrenner's ecological systems theory frames this study, with the child's environment conceptualized as interlocking microsystems that affect weight management.  Methods:  Interviews were conducted with 33 parents (85% mothers, 48% with university degree) of 33 children [mean age 9.3 (standard deviation 0.7), 46% girls] from Stockholm, Sweden. Interviews were analyzed using thematic analysis, focusing on parents' perceptions of interpersonal relationships: family, relatives, other children, preschool/school staff, and health care practitioners.  Results:  Two main themes were developed: (1)  Discouragement , with the subthemes  Conflicting rules  and  Social comparison , and (2)  Support and understanding , with the subthemes  Teamwork  and  Shared responsibility and continuity of care . Parents perceived children's weight management as a continuous orchestration of different influences across social spheres. Years after obesity treatment, parents struggled to maintain the child's healthy routines outside the home. However, when siblings, grandparents, teachers, and friends' parents acted supportively, routines were easier to maintain.  Conclusions:  The findings suggest that each microsystem in a child's environment has important influence on weight management, such that, as children grow older, children's lifestyles cannot be managed by parents alone. To facilitate weight management, more people in the child's environment should be involved early in the treatment process, and continued professional support should be offered to parents.",2021,This study explores how parents perceive the influence of interpersonal relationships on their children's eating and physical activity 4 years after participating in a randomized controlled trial.,"[""children's eating and physical activity 4 years after participating"", ""parents' perceptions of interpersonal relationships: family, relatives, other children, preschool/school staff, and health care practitioners"", '33 parents (85% mothers, 48% with university degree) of 33 children [mean age 9.3 (standard deviation 0.7), 46% girls] from Stockholm, Sweden']",[],"['subthemes  Conflicting rules  and  Social comparison , and (2)  Support and understanding , with the subthemes  Teamwork  and  Shared responsibility and continuity of care ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]",[],"[{'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}]",33.0,0.0144448,This study explores how parents perceive the influence of interpersonal relationships on their children's eating and physical activity 4 years after participating in a randomized controlled trial.,"[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Nowicka', 'Affiliation': 'Department of Food Studies, Nutrition, and Dietetics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ek', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Emeli', 'Initials': 'E', 'LastName': 'Grafström', 'Affiliation': 'Department of Food Studies, Nutrition, and Dietetics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tora', 'Initials': 'T', 'LastName': 'Johansson', 'Affiliation': 'Department of Food Studies, Nutrition, and Dietetics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nordin', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Nicklas', 'Initials': 'N', 'LastName': 'Neuman', 'Affiliation': 'Department of Food Studies, Nutrition, and Dietetics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Reijs Richards', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Eli', 'Affiliation': 'Department of Food Studies, Nutrition, and Dietetics, Uppsala University, Uppsala, Sweden.'}]",Childhood obesity (Print),['10.1089/chi.2021.0156']
3087,34768399,Tent versus Mask-On Acute Effects during Repeated-Sprint Training in Normobaric Hypoxia and Normoxia.,"Repeated sprint in hypoxia (RSH) is used to improve supramaximal cycling capacity, but little is known about the potential differences between different systems for creating normobaric hypoxia, such as a chamber, tent, or mask. This study aimed to compare the environmental (carbon dioxide (CO 2 ) and wet-globe bulb temperature (WGBT)), perceptual (pain, respiratory difficulty, and rate of perceived exertion (RPE)), and external (peak and mean power output) and internal (peak heart rate (HRpeak), muscle oxygen saturation (SmO 2 ), arterial oxygen saturation (SpO 2 ), blood lactate and glucose) workload acute effects of an RSH session when performed inside a tent versus using a mask. Twelve well-trained cyclists (age = 29 ± 9.8 years, VO 2 max = 70.3 ± 5.9 mL/kg/min) participated in this single-blind, randomized, crossover trial. Participants completed four sessions of three sets of five repetitions × 10 s:20 s (180 s rest between series) of all-out in different conditions: normoxia in a tent (RSNTent) and mask-on (RSNMask), and normobaric hypoxia in a tent (RSHTent) and mask-on (RSHMask). CO 2  and WGBT levels increased steadily in all conditions ( p  < 0.01) and were lower when using a mask (RSNMask and RSHMask) than when inside a tent (RSHTent and RSNTent) ( p  < 0.01). RSHTent presented lower SpO 2  than the other three conditions ( p  < 0.05), and hypoxic conditions presented lower SpO 2  than normoxic ones ( p  < 0.05). HRpeak, RPE, blood lactate, and blood glucose increased throughout the training, as expected. RSH could lead to acute conditions such as hypoxemia, which may be exacerbated when using a tent to simulate hypoxia compared to a mask-based system.",2021,"RSHTent presented lower SpO 2  than the other three conditions ( p  < 0.05), and hypoxic conditions presented lower SpO 2  than normoxic ones ( p  < 0.05).","['Twelve well-trained cyclists (age = 29 ± 9.8 years, VO 2 max = 70.3 ± 5.9 mL/kg/min']","['Repeated sprint in hypoxia (RSH', 'Repeated-Sprint Training', 'RSH', 'tent (RSNTent) and mask-on (RSNMask), and normobaric hypoxia in a tent (RSHTent) and mask-on (RSHMask']","['HRpeak, RPE, blood lactate, and blood glucose', 'CO 2  and WGBT levels', 'environmental (carbon dioxide (CO 2 ) and wet-globe bulb temperature (WGBT)), perceptual (pain, respiratory difficulty, and rate of perceived exertion (RPE)), and external (peak and mean power output) and internal (peak heart rate (HRpeak), muscle oxygen saturation (SmO 2 ), arterial oxygen saturation (SpO 2 ), blood lactate and glucose) workload acute effects of an RSH session']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}, {'cui': 'C0677506', 'cui_str': 'Tent'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0025148', 'cui_str': 'Medulla oblongata structure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0574401', 'cui_str': 'Samoan language'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",,0.0452476,"RSHTent presented lower SpO 2  than the other three conditions ( p  < 0.05), and hypoxic conditions presented lower SpO 2  than normoxic ones ( p  < 0.05).","[{'ForeName': 'Aldo A', 'Initials': 'AA', 'LastName': 'Vasquez-Bonilla', 'Affiliation': 'Grupo de Avances en Entrenamiento Deportivo y Acondicionamiento Físico (GAEDAF), Facultad de Ciencias del Deprote, Universidad de Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rojas-Valverde', 'Affiliation': 'Centro de Investigación y Diagnóstico en Salud y Deporte (CIDISAD), Escuela de Ciencias del Movimiento Humano y Calidad de Vida, Universidad Nacional, Heredia 86-3000, Costa Rica.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'González-Custodio', 'Affiliation': 'Grupo de Avances en Entrenamiento Deportivo y Acondicionamiento Físico (GAEDAF), Facultad de Ciencias del Deprote, Universidad de Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Timón', 'Affiliation': 'Grupo de Avances en Entrenamiento Deportivo y Acondicionamiento Físico (GAEDAF), Facultad de Ciencias del Deprote, Universidad de Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Olcina', 'Affiliation': 'Grupo de Avances en Entrenamiento Deportivo y Acondicionamiento Físico (GAEDAF), Facultad de Ciencias del Deprote, Universidad de Extremadura, 10003 Cáceres, Spain.'}]",Journal of clinical medicine,['10.3390/jcm10214879']
3088,34768378,Effect of Adding Midazolam to Dual Prophylaxis for Preventing Postoperative Nausea and Vomiting.,"Multimodal prophylaxis for postoperative nausea and vomiting (PONV) has been recommended, even in low-risk patients. Midazolam is known to have antiemetic properties. We researched the effects of adding midazolam to the dual prophylaxis of ondansetron and dexamethasone on PONV after gynecologic laparoscopy. In this prospective, randomized, double-blinded trial, 144 patients undergoing gynecological laparoscopic surgery under sevoflurane anesthesia were randomized to receive either normal saline (control group,  n  = 72) or midazolam 0.05 mg/kg (midazolam group,  n  = 72) intravenously at pre-induction. All patients were administered dexamethasone 4 mg at induction and ondansetron 4 mg at the completion of the laparoscopy, intravenously. The primary outcome was the incidence of complete response, which implied the absence of PONV without rescue antiemetic requirement until 24 h post-surgery. The complete response during the 24 h following laparoscopy was similar between the two groups: 41 patients (59%) in the control group and 48 patients (72%) in the midazolam group ( p  = 0.11). The incidence of nausea, severe nausea, retching/vomiting, and administration of rescue antiemetic was comparable between the two groups. The addition of 0.05 mg/kg midazolam at pre-induction to the dual prophylaxis had no additive preventive effect on PONV after gynecologic laparoscopy.",2021,"The incidence of nausea, severe nausea, retching/vomiting, and administration of rescue antiemetic was comparable between the two groups.",['144 patients undergoing gynecological laparoscopic surgery under sevoflurane anesthesia'],"['dexamethasone 4 mg at induction and ondansetron', 'Multimodal prophylaxis', 'normal saline (control group,  n  = 72) or midazolam 0.05 mg/kg (midazolam group,  n  = 72) intravenously at pre-induction', 'midazolam', 'ondansetron and dexamethasone', 'Midazolam']","['incidence of complete response, which implied the absence of PONV without rescue antiemetic requirement until 24 h post-surgery', 'complete response', 'postoperative nausea and vomiting (PONV', 'nausea, severe nausea, retching/vomiting, and administration of rescue antiemetic', 'Postoperative Nausea and Vomiting']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0985346', 'cui_str': 'Dexamethasone 4 MG'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0232602', 'cui_str': 'Retching'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",144.0,0.185549,"The incidence of nausea, severe nausea, retching/vomiting, and administration of rescue antiemetic was comparable between the two groups.","[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, 59 Yatap-ro, Bundang-gu, Seongnam 13496, Korea.'}, {'ForeName': 'In Kyong', 'Initials': 'IK', 'LastName': 'Yi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164 World Cup-ro, Yeongtong-gu, Suwon 16499, Korea.'}, {'ForeName': 'Jung Youn', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, 59 Yatap-ro, Bundang-gu, Seongnam 13496, Korea.'}, {'ForeName': 'Eun Duc', 'Initials': 'ED', 'LastName': 'Na', 'Affiliation': 'Department of Obstetrics and Gynecology, CHA Bundang Medical Center, CHA University, 59 Yatap-ro, Bundang-gu, Seongnam 13496, Korea.'}, {'ForeName': 'Chunghyun', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, 59 Yatap-ro, Bundang-gu, Seongnam 13496, Korea.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164 World Cup-ro, Yeongtong-gu, Suwon 16499, Korea.'}]",Journal of clinical medicine,['10.3390/jcm10214857']
3089,34768338,Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial.,"The need for oxygen increases with activity in patients with COPD and on long-term oxygen treatment (LTOT), leading to periods of hypoxemia, which may influence the patient's performance. This study aimed to evaluate the effect of automated oxygen titration compared to usual fixed-dose oxygen treatment during walking on dyspnea and endurance in patients with COPD and on LTOT. In a double-blinded randomised crossover trial, 33 patients were assigned to use either automated oxygen titration or the usual fixed-dose in a random order in two walking tests. A closed-loop device, O2matic delivered a variable oxygen dose set with a target saturation of 90-94%. The patients had a home oxygen flow of (mean ± SD) 1.6 ± 0.9 L/min. At the last corresponding isotime in the endurance shuttle walk test, the patients reported dyspnea equal to median (IQR) 4 (3-6) when using automated oxygen titration and 8 (5-9) when using fixed doses,  p  < 0.001. The patients walked 10.9 (6.5-14.9) min with automated oxygen compared to 5.5 (3.3-7.9) min with fixed-dose,  p  < 0.001. Walking with automated oxygen titration had a statistically significant and clinically important effect on dyspnea. Furthermore, the patients walked for a 98% longer time when hypoxemia was reduced with a more well-matched, personalised oxygen treatment.",2021,"The patients walked 10.9 (6.5-14.9) min with automated oxygen compared to 5.5 (3.3-7.9) min with fixed-dose,  p  < 0.001.","['33 patients', 'patients had a home oxygen flow of (mean ± SD) 1.6 ± 0.9 L/min', 'Chronic Hypoxemic Patients with COPD', 'patients with COPD and on LTOT', 'patients with COPD']","['automated oxygen titration', 'Automated Oxygen Titration during Walking']","['dyspnea', 'dyspnea and endurance', 'Dyspnea and Endurance', 'hypoxemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0421203', 'cui_str': 'Home oxygen supply'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",33.0,0.127819,"The patients walked 10.9 (6.5-14.9) min with automated oxygen compared to 5.5 (3.3-7.9) min with fixed-dose,  p  < 0.001.","[{'ForeName': 'Linette Marie', 'Initials': 'LM', 'LastName': 'Kofod', 'Affiliation': 'PMR-C, Department of Physio- and Occupational Therapy, Copenhagen University Hospital, 2650 Hvidovre, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Westerdahl', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, 702 81 Örebro, Sweden.'}, {'ForeName': 'Morten Tange', 'Initials': 'MT', 'LastName': 'Kristensen', 'Affiliation': 'PMR-C, Department of Physio- and Occupational Therapy, Copenhagen University Hospital, 2650 Hvidovre, Denmark.'}, {'ForeName': 'Barbara Cristina', 'Initials': 'BC', 'LastName': 'Brocki', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Aalborg University Hospital, 9000 Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ringbæk', 'Affiliation': 'Department of Pulmonology, Copenhagen University Hospital, Hvidovre, 2650 Hvidovre, Denmark.'}, {'ForeName': 'Ejvind Frausing', 'Initials': 'EF', 'LastName': 'Hansen', 'Affiliation': 'Department of Pulmonology, Copenhagen University Hospital, Hvidovre, 2650 Hvidovre, Denmark.'}]",Journal of clinical medicine,['10.3390/jcm10214820']
3090,34768288,"The feasibility and safety of disposable endoscope vs. conventional endoscope for upper gastrointestinal tract examination: a multicenter, randomized, parallel, non-inferiority trial.","BACKGROUND


A disposable upper gastrointestinal endoscope can effectively decrease infectious outbreaks associated with endoscope reuse. In the present study, we aimed to evaluate the feasibility and safety of a disposable endoscope for upper gastrointestinal examination.
METHODS


In a prospective, randomized trial, 144 upper endoscopic procedures were allocated to either the disposable endoscope group or the conventional endoscope group. The primary outcomes were rates of excellent and good image qualities and maneuverability satisfaction. The second outcome included procedure duration, endoscopic diagnosis, and adverse events.
RESULTS


A total of 144 subjects were enrolled in the present analysis and prospectively randomized to 2 study groups. Finally, 70 and 69 subjects were enrolled in the novel disposable endoscope group and the conventional endoscope group, respectively, due to the schedule cancellation of 5 subjects. The baseline characteristics of the patients were similar in both groups. The excellent and good image quality rates and maneuverability satisfaction of the novel disposable endoscope were not inferior to the conventional endoscope (p = 0.99 and p = 0.99, respectively). Moreover, no significant between-group difference was observed in the endoscopic results and adverse events (p = 0.30 and p = 1, respectively). However, the procedure duration in the novel disposable endoscope was longer compared with the conventional endoscope (8.40 ± 4.28 min  vs.  5.12 ± 2.65 min, p < 0.001).
CONCLUSIONS


The novel disposable endoscope was as safe, effective, and maneuverable as a conventional endoscope. However, the novel disposable endoscope was associated with a longer procedure duration.",2021,"The excellent and good image quality rates and maneuverability satisfaction of the novel disposable endoscope were not inferior to the conventional endoscope (p = 0.99 and p = 0.99, respectively).","['upper gastrointestinal tract examination', '144 upper endoscopic procedures', '70 and 69 subjects were enrolled in the novel disposable endoscope group and the conventional endoscope group, respectively, due to the schedule cancellation of 5 subjects', 'A total of 144 subjects']","['disposable endoscope group or the conventional endoscope group', 'disposable endoscope', 'disposable endoscope vs. conventional endoscope']","['endoscopic results and adverse events', 'excellent and good image quality rates and maneuverability satisfaction', 'rates of excellent and good image qualities and maneuverability satisfaction', 'procedure duration, endoscopic diagnosis, and adverse events', 'feasibility and safety']","[{'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",144.0,0.0406257,"The excellent and good image quality rates and maneuverability satisfaction of the novel disposable endoscope were not inferior to the conventional endoscope (p = 0.99 and p = 0.99, respectively).","[{'ForeName': 'De-Feng', 'Initials': 'DF', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology).""}, {'ForeName': 'Rui-Yue', 'Initials': 'RY', 'LastName': 'Shi', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology).""}, {'ForeName': 'Yan-Hui', 'Initials': 'YH', 'LastName': 'Tian', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology).""}, {'ForeName': 'Zheng-Lei', 'Initials': 'ZL', 'LastName': 'Xu', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology).""}, {'ForeName': 'Ying-Sheng', 'Initials': 'YS', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital.'}, {'ForeName': 'Xian-Jiu', 'Initials': 'XJ', 'LastName': 'Sun', 'Affiliation': 'Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital.'}, {'ForeName': 'Jin-Wei', 'Initials': 'JW', 'LastName': 'Cai', 'Affiliation': 'Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital.'}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Fang', 'Affiliation': 'Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital.'}, {'ForeName': 'Jia-Min', 'Initials': 'JM', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Dong', 'Affiliation': 'Shenzhen Pengrui Intelligent Image Co., Ltd.'}, {'ForeName': 'Yong-de', 'Initials': 'YD', 'LastName': 'Cai', 'Affiliation': 'Shenzhen Pengrui Intelligent Image Co., Ltd.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology).""}, {'ForeName': 'Li-Sheng', 'Initials': 'LS', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology).""}]",Zeitschrift fur Gastroenterologie,['10.1055/a-1555-0568']
3091,34768276,Commentary: Treatment-resistant Depression: Considerations Related to ECT and Ketamine.,"Treatment-resistant depression (TRD) may be responsive to interventions beyond antidepressants including brain stimulation such as electroconvulsive therapy (ECT) or to ketamine or esketamine, the latter of which is approved for TRD in an intranasal form. The 3 cases presented in this issue deal with an array of clinical considerations in treating patients with TRD, including the use of ECT in a patient with a history of liver transplantation, the use of heated yoga in a patient nonresponsive to ECT, and intranasal ketamine abuse in a patient with comorbid migraines. Gunther and colleagues described the case of a 73-year-old man who presented with a major depressive episode with psychotic features not responsive to medications 26 years after liver transplantation. Despite his past transplant and antirejection medications, the patient was cleared for ECT and received 9 bitemporal treatments with good response. Sakurai and colleagues reported the case of a 28-year-old woman with chronic TRD and multiple previous ECT treatments who had only a partial response to several antidepressants and maintenance ECT. She was evaluated and treated with a course of twice-weekly 90-minute heated yoga and experienced a remission of her depression. Finally, Rivas-Grajales and colleagues described a 52-year-old woman with recurrent TRD and chronic migraines who was receiving 2 antidepressants and migraine medication, who presented emergently with agitation and paranoia in the context of receiving intranasal ketamine from multiple providers, suggesting a pattern of misuse. Her symptoms abated despite her refusal of prescribed antipsychotics. These 3 cases highlight different challenges and complexities in treating patients with TRD. While ECT remains safe and effective, even in cases of organ transplantation, there is potential for the development of nonpharmacologic adjunctive treatments, such as heated yoga (which is under randomized study). And while eskatamine is an approved treatment for TRD, screening and ongoing monitoring is important to prevent misuse or abuse.",2021,"Treatment-resistant depression (TRD) may be responsive to interventions beyond antidepressants including brain stimulation such as electroconvulsive therapy (ECT) or to ketamine or esketamine, the latter of which is approved for TRD in an intranasal form.","['52-year-old woman with recurrent TRD and chronic migraines who was receiving 2 antidepressants and migraine medication, who presented emergently with agitation and paranoia in the context of receiving', 'patients with TRD', 'Treatment-resistant Depression', '73-year-old man who presented with a major depressive episode with psychotic features not responsive to medications 26 years after liver transplantation']","['intranasal ketamine', 'ketamine or esketamine', 'ECT and Ketamine', 'ECT', 'electroconvulsive therapy (ECT']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]",[],,0.032937,"Treatment-resistant depression (TRD) may be responsive to interventions beyond antidepressants including brain stimulation such as electroconvulsive therapy (ECT) or to ketamine or esketamine, the latter of which is approved for TRD in an intranasal form.","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Garakani', 'Affiliation': 'GARAKANI: Department of Psychiatry and Behavioral Health, Greenwich Hospital, Greenwich, CT; Department of Psychiatry, Yale University School of Medicine, New Haven, CT.'}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000593']
3092,34768274,A Patient With Electroconvulsive Therapy-resistant Major Depressive Disorder With a Full Response to Heated Yoga: A Case Report.,"Depression remains difficult to treat as a result of less than optimal efficacy and troublesome side effects of antidepressants. The authors present the case of a patient with treatment-resistant depression with melancholic features who had previously been unresponsive to electroconvulsive therapy (ECT) plus an antidepressant regimen but whose condition fully remitted with the addition of a standardized form of heated hatha yoga (HY; Bikram yoga) practiced in a room heated to 105°F. The patient was a 28-year-old woman who underwent 8 weeks of HY as part of a randomized controlled trial of HY for depression while continuing her antidepressant treatment. The patient was asked to attend a minimum of 2 weekly, 90-minute HY classes. After 8 weeks (12 classes in total), the patient no longer met the criteria for a major depressive episode with melancholic features, per Mini-International Neuropsychiatric Interview (MINI) criteria. Her depressive symptoms had improved dramatically, with Inventory of Depressive Symptomatology, Clinician-Rated (IDS-C30), and Hamilton Depression Rating Scale (HAM-D28) scores decreasing from 28 at baseline to 3, and from 28 at baseline to 4, respectively, indicating remission. This patient's ECT-resistant depression remitted with the addition of HY to her antidepressant regimen. Because of her youth and athleticism, this patient was likely well suited to this rigorous form of yoga. Further research is needed to explore HY as a potential intervention for treatment-resistant depression.",2021,"After 8 weeks (12 classes in total), the patient no longer met the criteria for a major depressive episode with melancholic features, per Mini-International Neuropsychiatric Interview (MINI) criteria.","['patient was a 28-year-old woman who underwent 8 weeks of HY as part of a randomized controlled trial of HY for depression while continuing her antidepressant treatment', 'patient with treatment-resistant depression with melancholic features who had previously been unresponsive to electroconvulsive therapy (ECT) plus an antidepressant regimen but whose condition fully remitted with the addition of a standardized form of heated hatha yoga (HY; Bikram yoga) practiced in a room heated to 105°F', 'resistant Major Depressive Disorder']",['Electroconvulsive Therapy'],"['Her depressive symptoms', 'Inventory of Depressive Symptomatology, Clinician-Rated (IDS-C30), and Hamilton Depression Rating Scale (HAM-D28) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.125288,"After 8 weeks (12 classes in total), the patient no longer met the criteria for a major depressive episode with melancholic features, per Mini-International Neuropsychiatric Interview (MINI) criteria.","[{'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Sakurai', 'Affiliation': ''}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Norton', 'Affiliation': ''}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Megha V', 'Initials': 'MV', 'LastName': 'Nagaswami', 'Affiliation': ''}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Streeter', 'Affiliation': ''}, {'ForeName': 'Ashley K', 'Initials': 'AK', 'LastName': 'Meyer', 'Affiliation': ''}, {'ForeName': 'Taquesha', 'Initials': 'T', 'LastName': 'Dean', 'Affiliation': ''}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mischoulon', 'Affiliation': ''}, {'ForeName': 'Maren B', 'Initials': 'MB', 'LastName': 'Nyer', 'Affiliation': ''}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000587']
3093,34768623,Stent Selection for Primary Angioplasty and Outcomes in the Era of Potent Antiplatelets. Data from the Multicenter Randomized Prague-18 Trial.,"Drug-eluting stents (DES) are the recommended stents for primary percutaneous coronary intervention (PCI). This study aimed to determine why interventional cardiologists used non-DES and how it influenced patient prognoses. The efficacy and safety outcomes of the different stents were also compared in patients treated with either prasugrel or ticagrelor. Of the PRAGUE-18 study patients, 749 (67.4%) were treated with DES, 296 (26.6%) with bare-metal stents (BMS), and 66 (5.9%) with bioabsorbable vascular scaffold/stents (BVS) between 2013 and 2016. Cardiogenic shock at presentation, left main coronary artery disease, especially as the culprit lesion, and right coronary artery stenosis were the reasons for selecting a BMS. The incidence of the primary composite net-clinical endpoint (EP) (death, nonfatal myocardial infarction, stroke, serious bleeding, or revascularization) at seven days was 2.5% vs. 6.3% and 3.0% in the DES, vs. with BMS and BVS, respectively (HR 2.7; 95% CI 1.419-5.15,  p  = 0.002 for BMS vs. DES and 1.25 (0.29-5.39)  p  = 0.76 for BVS vs. DES). Patients with BMS were at higher risk of death at 30 days (HR 2.20; 95% CI 1.01-4.76; for BMS vs. DES,  p  = 0.045) and at one year (HR 2.1; 95% CI 1.19-3.69;  p  = 0.01); they also had a higher composite of cardiac death, reinfarction, and stroke (HR 1.66; 95% CI 1.0-2.74; p = 0.047) at one year. BMS were associated with a significantly higher rate of primary EP whether treated with prasugrel or ticagrelor. In conclusion, patients with the highest initial risk profile were preferably treated with BMS over BVS. BMS were associated with a significantly higher rate of cardiovascular events whether treated with prasugrel or ticagrelor.",2021,"Patients with BMS were at higher risk of death at 30 days (HR 2.20; 95% CI 1.01-4.76; for BMS vs. DES,  p  = 0.045) and at one year (HR 2.1; 95% CI 1.19-3.69;  p  = 0.01); they also had a higher composite of cardiac death, reinfarction, and stroke (HR 1.66; 95% CI 1.0-2.74; p = 0.047) at one year.","['primary percutaneous coronary intervention (PCI', 'patients, 749 (67.4%) were treated with DES, 296 (26.6%) with bare-metal stents (BMS), and 66 (5.9%) with bioabsorbable vascular scaffold/stents (BVS) between 2013 and 2016', 'patients with the highest initial risk profile']","['Drug-eluting stents (DES', 'prasugrel or ticagrelor']","['risk of death', 'cardiac death, reinfarction, and stroke', 'rate of cardiovascular events', 'incidence of the primary composite net-clinical endpoint (EP) (death, nonfatal myocardial infarction, stroke, serious bleeding, or revascularization', 'BMS', 'efficacy and safety outcomes']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0484959,"Patients with BMS were at higher risk of death at 30 days (HR 2.20; 95% CI 1.01-4.76; for BMS vs. DES,  p  = 0.045) and at one year (HR 2.1; 95% CI 1.19-3.69;  p  = 0.01); they also had a higher composite of cardiac death, reinfarction, and stroke (HR 1.66; 95% CI 1.0-2.74; p = 0.047) at one year.","[{'ForeName': 'Ota', 'Initials': 'O', 'LastName': 'Hlinomaz', 'Affiliation': 'ICRC, Department of Cardioangiology, St. Anne University Hospital, Masaryk University, 65691 Brno, Czech Republic.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Motovska', 'Affiliation': 'Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Cardiocentre, 10034 Prague, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Knot', 'Affiliation': 'Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Cardiocentre, 10034 Prague, Czech Republic.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Miklik', 'Affiliation': 'Department of Internal Medicine and Cardiology, Faculty of Medicine of Masaryk University and University Hospital, 62500 Brno, Czech Republic.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Sabbah', 'Affiliation': 'ICRC, Department of Cardioangiology, St. Anne University Hospital, Masaryk University, 65691 Brno, Czech Republic.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Hromadka', 'Affiliation': 'Department of Cardiology, University Hospital and Faculty of Medicine, Charles University, 30599 Pilsen, Czech Republic.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Varvarovsky', 'Affiliation': 'Cardiology Centre AGEL, 53203 Pardubice, Czech Republic.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Dusek', 'Affiliation': 'First Department of Internal Medicine, University Hospital Hradec Kralove, 50005 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Svoboda', 'Affiliation': 'Faculty of Medicine, Institute of Biostatistics and Analyses, Masaryk University, 62500 Brno, Czech Republic.'}, {'ForeName': 'Frantisek', 'Initials': 'F', 'LastName': 'Tousek', 'Affiliation': 'Cardiocentre-Department of Cardiology, Regional Hospital, 37001 Ceske Budejovice, Czech Republic.'}, {'ForeName': 'Bohumil', 'Initials': 'B', 'LastName': 'Majtan', 'Affiliation': 'Cardiocentre, Regional Hospital, 36001 Karlovy Vary, Czech Republic.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Simek', 'Affiliation': 'Department of Physiology and Second Department of Medicine-Department of Cardiovascular Medicine, 1st Faculty of Medicine, Charles University, 12808 Prague, Czech Republic.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Branny', 'Affiliation': 'Cardiovascular Center, Hospital Podlesi, AGEL Research and Training Institute, 73961 Trinec, Czech Republic.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Jarkovský', 'Affiliation': 'Faculty of Medicine, Institute of Biostatistics and Analyses, Masaryk University, 62500 Brno, Czech Republic.'}]",Journal of clinical medicine,['10.3390/jcm10215103']
3094,34768614,"The Added Value of Subcutaneous Peripheral Nerve Field Stimulation Combined with SCS, as Salvage Therapy, for Refractory Low Back Pain Component in Persistent Spinal Pain Syndrome Implanted Patients: A Randomized Controlled Study (CUMPNS Study) Based on 3D-Mapping Composite Pain Assessment.","While Spinal Cord Stimulation (SCS) provides satisfaction to almost 2/3 of Persistent Spinal Pain Syndrome-Type 2 (PSPS-T2) patients implanted for refractory chronic back and/or leg pain, when not adequately addressed the back pain component, leaves patients in a therapeutic cul-de-sac. Peripheral Nerve field Stimulation (PNfS) has shown interesting results addressing back pain in the same population. Far from placing these two techniques in opposition, we suggest that these approaches could be combined to better treat PSPS-T2 patients. We designed a RCT (CUMPNS), with a 12-month follow-up, to assess the potential added value of PNfS, as a salvage therapy, in PSPS-T2 patients experiencing a ""Failed SCS Syndrome"" in the back pain component. Fourteen patients were included in this study and randomized into 2 groups (""SCS + PNfS"" group/ n  = 6 vs. ""SCS only"" group/ n  = 8). The primary objective of the study was to compare the percentage of back pain surface decrease after 3 months, using a computerized interface to obtain quantitative pain mappings, combined with multi-dimensional SCS outcomes. Back pain surface decreased significantly greater for the ""SCS + PNfS"" group (80.2% ± 21.3%) compared to the ""SCS only"" group (13.2% ± 94.8%) ( p  = 0.012), highlighting the clinical interest of SCS + PNfS, in cases where SCS fails to address back pain.",2021,"Back pain surface decreased significantly greater for the ""SCS + PNfS"" group (80.2% ± 21.3%) compared to the ""SCS only"" group (13.2% ± 94.8%) ( p  = 0.012), highlighting the clinical interest of SCS + PNfS, in cases where SCS fails to address back pain.","['Fourteen patients', 'Persistent Spinal Pain Syndrome', 'PSPS-T2 patients experiencing a ""Failed SCS Syndrome"" in the back pain component', 'Implanted Patients']","['RCT (CUMPNS', 'While Spinal Cord Stimulation (SCS', 'Peripheral Nerve field Stimulation (PNfS', 'SCS + PNfS"" group/ n  = 6 vs. ""SCS only"" group/ n  = 8', 'Subcutaneous Peripheral Nerve Field Stimulation Combined with SCS', 'SCS + PNfS']","['percentage of back pain surface', 'Back pain surface']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0423673', 'cui_str': 'Pain in spine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",14.0,0.0293892,"Back pain surface decreased significantly greater for the ""SCS + PNfS"" group (80.2% ± 21.3%) compared to the ""SCS only"" group (13.2% ± 94.8%) ( p  = 0.012), highlighting the clinical interest of SCS + PNfS, in cases where SCS fails to address back pain.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rigoard', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Ounajim', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Goudman', 'Affiliation': 'Department of Neurosurgery, Universitair Ziekenhuis Brussel, 1090 Brussels, Belgium.'}, {'ForeName': 'Benedicte', 'Initials': 'B', 'LastName': 'Bouche', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Roulaud', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Page', 'Affiliation': 'STIMULUS Research Group, Vrije Universiteit Brussel, 1090 Brussels, Belgium.'}, {'ForeName': 'Bertille', 'Initials': 'B', 'LastName': 'Lorgeoux', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Baron', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Nivole', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Many', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Nihel', 'Initials': 'N', 'LastName': 'Adjali', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Charrier', 'Affiliation': 'Pain Evaluation and Treatment Centre, Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Rannou', 'Affiliation': 'Pain Evaluation and Treatment Centre, Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Poupin', 'Affiliation': 'Pain Evaluation and Treatment Centre, Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Wood', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'David', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Héraud', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}, {'ForeName': 'Maartens', 'Initials': 'M', 'LastName': 'Moens', 'Affiliation': 'Department of Neurosurgery, Universitair Ziekenhuis Brussel, 1090 Brussels, Belgium.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Billot', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.'}]",Journal of clinical medicine,['10.3390/jcm10215094']
3095,34768563,Immediate Effects of Kinesio Taping on Rectus Abdominis Diastasis in Postpartum Women-Preliminary Report.,"BACKGROUND


Rectus abdominis diastasis (RAD) is an excessive divarication of the rectus abdominis muscle with concurrent stretching and thinning of the linea alba, which occurs due to mechanical and functional disturbances in the anterior abdominal wall and the whole body. The primary objective of this study is a palpation assessment of RAD in postpartum women before and after the application of KT tapes and a subsequent comparison of the results with those from a sham intervention group.
METHODS


A randomized clinical trial was conducted in the Physical Therapy Department at Wroclaw Medical University. The participants were randomly assigned to one of two groups: the KT group (intervention), in which KT tapes were applied (48 h intervention) and the sham KT group (control, sham intervention), in which non-stretch tapes were used (cloth surgical tape, 48 h intervention). In all participants, a palpation assessment of RAD was conducted and the inter-recti distance was measured using a digital caliper at three sites: at the umbilicus and 4.5 cm above and below it. Measurements were taken before and after the intervention.
RESULTS


The gathered results show a statistically significant reduction in rectus abdominis diastasis at each of the observed sites after the application of KT tapes in the intervention group ( p  < 0.05). In the intergroup comparison, a statistically significantly lower RAD (at umbilicus) was found after the intervention ( p  = 0.005) in KT group.
CONCLUSIONS


the application of KT tapes using the corrective technique can contribute to reducing RAD in women up to 12 months after delivery.",2021,the application of KT tapes using the corrective technique can contribute to reducing RAD in women up to 12 months after delivery.,"['Postpartum Women-Preliminary Report', 'Physical Therapy Department at Wroclaw Medical University']","['Kinesio Taping', 'Rectus abdominis diastasis (RAD', 'KT group (intervention), in which KT tapes were applied (48 h intervention) and the sham KT group (control, sham intervention']","['RAD', 'Rectus Abdominis Diastasis', 'palpation assessment of RAD', 'rectus abdominis diastasis']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0307125,the application of KT tapes using the corrective technique can contribute to reducing RAD in women up to 12 months after delivery.,"[{'ForeName': 'Lucyna', 'Initials': 'L', 'LastName': 'Ptaszkowska', 'Affiliation': 'Institute of Health Science, University of Opole, Katowicka 68, 45-060 Opole, Poland.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Gorecka', 'Affiliation': 'Department of Physiotherapy, Wroclaw Medical University, Grunwaldzka 2, 50-355 Wroclaw, Poland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Paprocka-Borowicz', 'Affiliation': 'Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Faculty of Health Science, Wroclaw Medical University, Grunwaldzka 2, 50-355 Wroclaw, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Walewicz', 'Affiliation': 'Institute of Health Science, University of Opole, Katowicka 68, 45-060 Opole, Poland.'}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Jarzab', 'Affiliation': 'Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Faculty of Health Science, Wroclaw Medical University, Grunwaldzka 2, 50-355 Wroclaw, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Majewska-Pulsakowska', 'Affiliation': 'Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Faculty of Health Science, Wroclaw Medical University, Grunwaldzka 2, 50-355 Wroclaw, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Gorka-Dynysiewicz', 'Affiliation': 'Department of Pharmaceutical Biochemistry, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jenczura', 'Affiliation': 'Institute of Health Science, University of Opole, Katowicka 68, 45-060 Opole, Poland.'}, {'ForeName': 'Kuba', 'Initials': 'K', 'LastName': 'Ptaszkowski', 'Affiliation': 'Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Faculty of Health Science, Wroclaw Medical University, Grunwaldzka 2, 50-355 Wroclaw, Poland.'}]",Journal of clinical medicine,['10.3390/jcm10215043']
3096,34768528,Carotid Artery Temperature Reduction with Statin Therapy in Patients with Familial Hyperlipidemia Syndromes.,"BACKGROUND


Microwave radiometry (MWR) assesses non-invasive carotid artery temperatures reflecting inflammation. In the present study, we aimed to investigate the impact of hypolipidemic therapy either with simvastatin or with combination simvastatin plus ezetimibe on carotid artery temperatures of patients with familial hyperlipidemia syndromes (FHS).
METHODS


Consecutive patients with diagnosis of either familial heterozygous hypercholesterolemia (heFH) or familial combined hyperlipidemia (FCH) were included in the study. Patients were assigned to either simvastatin 40 mg or simvastatin 40 mg plus ezetimibe 10 mg, according to the discretion of the physician. FHS patients who refused statin therapy were used as a control group. Common carotid intima-media thickness (ccIMT) was measured and ΔΤ (maximum-minimum) temperature measurements were performed across each carotid during MWR evaluation.
RESULTS


In total, 115 patients were included in the study. Of them, 40 patients received simvastatin (19 heFH and 21 FCH), 41 simvastatin + ezetimibe (31 heFH and 10 FCH), and 34 (21 heFH and 13 FCH) no statin. Carotid artery temperatures were significantly reduced at 6 months in FH patients who received hypolipidemic treatment (0.83 ± 0.34 versus 0.63 ± 0.24 °C,  p  = 0.004 for simvastatin, 1.00 ± 0.38 versus 0.69 ± 0.23 °C,  p  < 0.001 for simvastatin + ezetimibe), but no change was recorded in controls (0.72 ± 0.26 versus 0.70 ± 0.26 °C,  p  = 0.86).
CONCLUSIONS


Hypolipidemic therapy reduced carotid temperatures in FHS patients.",2021,"but no change was recorded in controls (0.72 ± 0.26 versus 0.70 ± 0.26 °C,  p  = 0.86).
","['FHS patients who refused', 'FHS patients', 'Consecutive patients with diagnosis of either familial heterozygous hypercholesterolemia (heFH) or familial combined hyperlipidemia (FCH', '115 patients were included in the study', 'patients with familial hyperlipidemia syndromes (FHS', 'Patients with Familial Hyperlipidemia Syndromes']","['Microwave radiometry (MWR', 'simvastatin (19 heFH and 21 FCH), 41 simvastatin + ezetimibe', 'hypolipidemic', 'statin therapy', 'statin', 'Hypolipidemic therapy', 'Statin Therapy', 'simvastatin + ezetimibe', 'simvastatin 40 mg or simvastatin 40 mg plus ezetimibe', 'simvastatin or with combination simvastatin plus ezetimibe']","['Carotid artery temperatures', 'Common carotid intima-media thickness (ccIMT', 'carotid artery temperatures', 'carotid temperatures']","[{'cui': 'C0694546', 'cui_str': 'Familial hyperlipidemia'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020474', 'cui_str': 'Familial combined hyperlipidemia'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026051', 'cui_str': 'Microwave'}, {'cui': 'C0034603', 'cui_str': 'Radiation Dosimetry'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0020474', 'cui_str': 'Familial combined hyperlipidemia'}, {'cui': 'C1532737', 'cui_str': 'simvastatin and ezetimibe'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0989916', 'cui_str': 'Simvastatin 40 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}]","[{'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",115.0,0.0388181,"but no change was recorded in controls (0.72 ± 0.26 versus 0.70 ± 0.26 °C,  p  = 0.86).
","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Benetos', 'Affiliation': 'First Department of Cardiology, National & Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Galanakos', 'Affiliation': 'First Department of Cardiology, National & Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Iosif', 'Initials': 'I', 'LastName': 'Koutagiar', 'Affiliation': 'First Department of Cardiology, National & Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Skoumas', 'Affiliation': 'First Department of Cardiology, National & Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Oikonomou', 'Affiliation': 'First Department of Cardiology, National & Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Drakopoulou', 'Affiliation': 'First Department of Cardiology, National & Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karmpalioti', 'Affiliation': 'First Department of Cardiology, National & Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Katsi', 'Affiliation': 'First Department of Cardiology, National & Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Costas', 'Initials': 'C', 'LastName': 'Tsioufis', 'Affiliation': 'First Department of Cardiology, National & Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Toutouzas', 'Affiliation': 'First Department of Cardiology, National & Kapodistrian University of Athens, 11527 Athens, Greece.'}]",Journal of clinical medicine,['10.3390/jcm10215008']
3097,34768520,"Myofascial Induction Therapy Improves the Sequelae of Medical Treatment in Head and Neck Cancer Survivors: A Single-Blind, Placebo-Controlled, Randomized Cross-Over Study.","Head and neck cancer (HNC) is the sixth most common cancer worldwide. Yet, less than 60% of HNC survivors receive adequate therapy for treatment-related sequelae. The objective of this study was to determine the efficacy of myofascial induction therapy (MIT) in improving cervical and shoulder pain and range of motion, maximal mouth opening, and cervical muscle function in HNC survivors. This crossover, blinded, placebo-controlled study involved 22 HNC survivors (average age 56.55 ± 12.71) of which 13 were males (59.1%) who received, in a crossover fashion, both a single 30-min session of MIT in the form of manual unwinding and simulated pulsed shortwave therapy (placebo), with a 4-week washout interval between the two. Cervical and shoulder pain (visual analogue scale) and range of motion (cervical range of motion device and goniometer), maximum mouth opening (digital caliper), and cervical muscle function (deep cervical flexor endurance test) were measured before and after the treatment and placebo sessions. A single session of MIT improved cervical and affected side shoulder pain, cervical range of motion, maximum mouth opening, and cervical muscle function. The associated effect sizes ranged from moderate to large. The present study suggests that MIT, in the form of manual unwinding, improves cervical (-3.91 ± 2.77) and affected-side shoulder (-3.64 ± 3.1) pain, cervical range of motion (flexion: 8.41 ± 8.26 deg; extension: 12.23 ± 6.55; affected-side rotation: 14.27 ± 11.05; unaffected-side rotation: 11.73 ± 8.65; affected-side lateroflexion: 7.95 ± 5.1; unaffected-side lateroflexion: 9.55 ± 6.6), maximum mouth opening (3.36 ± 3.4 mm), and cervical muscle function (8.09 ± 6.96 s) in HNC survivors.",2021,"A single session of MIT improved cervical and affected side shoulder pain, cervical range of motion, maximum mouth opening, and cervical muscle function.","['Head and Neck Cancer Survivors', '3.36 ± 3.4 mm), and cervical muscle function (8.09 ± 6.96 s) in HNC survivors', '22 HNC survivors (average age 56.55 ± 12.71) of which 13 were males (59.1%) who received, in a crossover fashion, both a single 30-min session of MIT in the form of', 'HNC survivors']","['Placebo', 'myofascial induction therapy (MIT', 'manual unwinding and simulated pulsed shortwave therapy (placebo', 'Myofascial Induction Therapy', 'placebo']","['Cervical and shoulder pain (visual analogue scale) and range of motion (cervical range of motion device and goniometer), maximum mouth opening (digital caliper), and cervical muscle function (deep cervical flexor endurance test', 'maximum mouth opening', 'side shoulder pain, cervical range of motion, maximum mouth opening, and cervical muscle function', 'cervical and shoulder pain and range of motion, maximal mouth opening, and cervical muscle function']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0037000', 'cui_str': 'Short Wave Therapy'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0175720', 'cui_str': 'Caliper'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",22.0,0.125017,"A single session of MIT improved cervical and affected side shoulder pain, cervical range of motion, maximum mouth opening, and cervical muscle function.","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Castro-Martín', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Galiano-Castillo', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernández-Lao', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Ortiz-Comino', 'Affiliation': ""'Cuídate' Support Unit for Oncology Patients, 18016 Granada, Spain.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Postigo-Martin', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, 18016 Granada, Spain.'}]",Journal of clinical medicine,['10.3390/jcm10215003']
3098,34768502,The Main Role of Diaphragm Muscle as a Mechanism of Hypopressive Abdominal Gymnastics to Improve Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial.,"BACKGROUND


Chronic low back pain (LBP) has been stated as one of the main health concerns in the XXI century due to its high incidence.
OBJECTIVE


The objective of this study was to determine the effects of an 8-week program of hypopressive abdominal gymnastics (HAG) on inspiratory muscle strength, diaphragm thickness, disability and pain in patients suffering from non-specific chronic LBP.
METHODS


A total of 40 patients with chronic LBP were randomly divided into two groups. The experimental group carried out an 8-week supervised program of HAG (two sessions/week), whereas the control group did not receive any treatment. Outcomes were measured before and after the intervention, comprising diaphragm thickness during relaxed respiratory activity, maximal inspiratory pressure (PI max ), pain intensity (NRS), pressure pain threshold and responses to four questionnaires: Physical Activity Questionnaire (PAQ), Roland-Morris Disability Questionnaire (RMQ), Central Sensitization Inventory (CSI) and Tampa Scale of Kinesiophobia-11 Items (TSK-11).
RESULTS


Statistically significant differences ( p  < 0.05) were observed for greater thickness of the left and right hemi-diaphragms at inspiration, as well as higher PI max  and decreased NRS, CSI and RMQ scores in the intervention group. After treatment, the increases in the thickness of the left and right hemi-diaphragms at inspiration and PI max , as well as the decrease in the NRS and RMQ scores, were only predicted by the proposed intervention ( R 2  = 0.118-0.552).
CONCLUSIONS


An 8-week HAG intervention seemed to show beneficial effects and predicted an increase in diaphragm thickness and strength during inspiration, as well as a reduction in pain intensity, central sensitization and disability, in patients suffering from chronic non-specific LBP with respect to non-intervention.",2021,"Statistically significant differences ( p  < 0.05) were observed for greater thickness of the left and right hemi-diaphragms at inspiration, as well as higher PI max  and decreased NRS, CSI and RMQ scores in the intervention group.","['40 patients with chronic LBP', 'patients suffering from chronic non-specific LBP with respect to non-intervention', 'Chronic low back pain (LBP', 'patients suffering from non-specific chronic LBP', 'Specific Chronic Low Back Pain']","['control group did not receive any treatment', 'HAG intervention', 'hypopressive abdominal gymnastics (HAG']","['diaphragm thickness and strength', 'higher PI max  and decreased NRS, CSI and RMQ scores', 'NRS and RMQ scores', 'pain intensity, central sensitization and disability', 'thickness of the left and right hemi-diaphragms at inspiration and PI max', 'inspiratory muscle strength, diaphragm thickness, disability and pain', 'diaphragm thickness during relaxed respiratory activity, maximal inspiratory pressure (PI max ), pain intensity (NRS), pressure pain threshold and responses to four questionnaires: Physical Activity Questionnaire (PAQ), Roland-Morris Disability Questionnaire (RMQ), Central Sensitization Inventory (CSI) and Tampa Scale of Kinesiophobia-11 Items (TSK-11']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}]",40.0,0.0324838,"Statistically significant differences ( p  < 0.05) were observed for greater thickness of the left and right hemi-diaphragms at inspiration, as well as higher PI max  and decreased NRS, CSI and RMQ scores in the intervention group.","[{'ForeName': 'Davinia', 'Initials': 'D', 'LastName': 'Vicente-Campos', 'Affiliation': 'Faculty of Health Sciences, Universidad Francisco de Vitoria, Pozuelo de Alarcón, 28223 Madrid, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sanchez-Jorge', 'Affiliation': 'Faculty of Health Sciences, Universidad Francisco de Vitoria, Pozuelo de Alarcón, 28223 Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Terrón-Manrique', 'Affiliation': 'Faculty of Health Sciences, Universidad Francisco de Vitoria, Pozuelo de Alarcón, 28223 Madrid, Spain.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Guisard', 'Affiliation': 'Faculty of Health Sciences, Universidad Francisco de Vitoria, Pozuelo de Alarcón, 28223 Madrid, Spain.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Collin', 'Affiliation': 'Faculty of Health Sciences, Universidad Francisco de Vitoria, Pozuelo de Alarcón, 28223 Madrid, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Castaño', 'Affiliation': 'Faculty of Health Sciences, Universidad Francisco de Vitoria, Pozuelo de Alarcón, 28223 Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Becerro-de-Bengoa-Vallejo', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'José López', 'Initials': 'JL', 'LastName': 'Chicharro', 'Affiliation': 'Grupo FEBIO, Universidad Complutense de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, 28040 Madrid, Spain.'}]",Journal of clinical medicine,['10.3390/jcm10214983']
3099,34768453,Prevalence of Perineal Tear Peripartum after Two Antepartum Perineal Massage Techniques: A Non-Randomised Controlled Trial.,"Perineal massage increases elasticity of myofascial perineal tissue and decreases the burning and perineal pain during labour, thus optimising child birth, although an application protocol has not been standardised yet. The objective of this study is to determine the efficiency of massage in perineal tear prevention and identification of possible differences in massage application. Total of 90 pregnant participants were divided into three groups: perineal massage and EPI-NO ®  device group, applied by an expert physiotherapist, self-massage group, where women were instructed to apply perineal massage in domestic household, and a control group, which received ordinary obstetric attention. Results: The results showed significant differences among the control group and the two perineal massage groups in perineal postpartum pain. Correlations in perineal postpartum pain, labour duration and the baby's weight were not statistically significant. Lithotomy posture was significantly less prevalent in the massage group than in the other two; this variable is known to have a direct effect on episiotomy incidence and could act as a causal covariate of the different incidence of episiotomy in the groups. Perineal massage reduces postpartum perineal pain, prevalence and severity of perineal tear during delivery.",2021,"Perineal massage increases elasticity of myofascial perineal tissue and decreases the burning and perineal pain during labour, thus optimising child birth, although an application protocol has not been standardised yet.",['90 pregnant participants'],"['perineal massage and EPI', 'Perineal Tear Peripartum after Two Antepartum Perineal Massage Techniques', 'Perineal massage', 'perineal massage in domestic household, and a control group, which received ordinary obstetric attention']","['burning and perineal pain', 'Lithotomy posture', 'perineal postpartum pain', 'postpartum perineal pain, prevalence and severity of perineal tear during delivery', ""perineal postpartum pain, labour duration and the baby's weight""]","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum'}, {'cui': 'C2936491', 'cui_str': 'Peripartum period'}, {'cui': 'C0456336', 'cui_str': 'Antepartum'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C1293108', 'cui_str': 'Lithotomy'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0848200', 'cui_str': 'Afterbirth pain'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",90.0,0.0371135,"Perineal massage increases elasticity of myofascial perineal tissue and decreases the burning and perineal pain during labour, thus optimising child birth, although an application protocol has not been standardised yet.","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Álvarez-González', 'Affiliation': 'Faculty of Health Sciences, Universidad de León, Astorga Ave. s/n, 24401 Ponferrada, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Leirós-Rodríguez', 'Affiliation': 'SALBIS Research Group, Faculty of Health Sciences, Universidad de León, Astorga Ave. s/n, 24401 Ponferrada, Spain.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Álvarez-Barrio', 'Affiliation': 'Faculty of Health Sciences, Universidad de León, Astorga Ave. s/n, 24401 Ponferrada, Spain.'}, {'ForeName': 'Ana F', 'Initials': 'AF', 'LastName': 'López-Rodríguez', 'Affiliation': 'Faculty of Health Sciences, Universidad de León, Astorga Ave. s/n, 24401 Ponferrada, Spain.'}]",Journal of clinical medicine,['10.3390/jcm10214934']
3100,34768722,Exploring Early Pre-Symptomatic Detection of Influenza Using Continuous Monitoring of Advanced Physiological Parameters during a Randomized Controlled Trial.,"Early detection of influenza may improve responses against outbreaks. This study was part of a clinical study assessing the efficacy of a novel influenza vaccine, aiming to discover distinct, highly predictive patterns of pre-symptomatic illness based on changes in advanced physiological parameters using a novel wearable sensor. Participants were frequently monitored 24 h before and for nine days after the influenza challenge. Viral load was measured daily, and self-reported symptoms were collected twice a day. The Random Forest classifier model was used to classify the participants based on changes in the measured parameters. A total of 116 participants with ~3,400,000 data points were included. Changes in parameters were detected at an early stage of the disease, before the development of symptomatic illness. Heart rate, blood pressure, cardiac output, and systemic vascular resistance showed the greatest changes in the third post-exposure day, correlating with viral load. Applying the classifier model identified participants as flu-positive or negative with an accuracy of 0.81 ± 0.05 two days before major symptoms appeared. Cardiac index and diastolic blood pressure were the leading predicting factors when using data from the first and second day. This study suggests that frequent remote monitoring of advanced physiological parameters may provide early pre-symptomatic detection of flu.",2021,"Heart rate, blood pressure, cardiac output, and systemic vascular resistance showed the greatest changes in the third post-exposure day, correlating with viral load.","['116 participants with ~3,400,000 data points were included']",['novel influenza vaccine'],"['Heart rate, blood pressure, cardiac output, and systemic vascular resistance', 'Cardiac index and diastolic blood pressure']","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",116.0,0.087435,"Heart rate, blood pressure, cardiac output, and systemic vascular resistance showed the greatest changes in the third post-exposure day, correlating with viral load.","[{'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Goldstein', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, and Sylvan Adams Sports Institute, Tel-Aviv University, Tel-Aviv 6997801, Israel.'}, {'ForeName': 'Arik', 'Initials': 'A', 'LastName': 'Eisenkraft', 'Affiliation': 'Biobeat Technologies LTD, Petah Tikva 4951122, Israel.'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Arguello', 'Affiliation': 'Leidos, Reston, VA 20190, USA.'}, {'ForeName': 'Ge Justin', 'Initials': 'GJ', 'LastName': 'Yang', 'Affiliation': 'Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA), Washington, DC 20201, USA.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Sand', 'Affiliation': 'Biobeat Technologies LTD, Petah Tikva 4951122, Israel.'}, {'ForeName': 'Arik Ben', 'Initials': 'AB', 'LastName': 'Ishay', 'Affiliation': 'Biobeat Technologies LTD, Petah Tikva 4951122, Israel.'}, {'ForeName': 'Roei', 'Initials': 'R', 'LastName': 'Merin', 'Affiliation': 'Biobeat Technologies LTD, Petah Tikva 4951122, Israel.'}, {'ForeName': 'Meir', 'Initials': 'M', 'LastName': 'Fons', 'Affiliation': 'Biobeat Technologies LTD, Petah Tikva 4951122, Israel.'}, {'ForeName': 'Romi', 'Initials': 'R', 'LastName': 'Littman', 'Affiliation': 'Biobeat Technologies LTD, Petah Tikva 4951122, Israel.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Nachman', 'Affiliation': 'The Institute for Research in Military Medicine, The Hebrew University Faculty of Medicine, The Israel Defense Force Medical Corps, Jerusalem 9112102, Israel.'}, {'ForeName': 'Yftach', 'Initials': 'Y', 'LastName': 'Gepner', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, and Sylvan Adams Sports Institute, Tel-Aviv University, Tel-Aviv 6997801, Israel.'}]",Journal of clinical medicine,['10.3390/jcm10215202']
3101,34768696,Median Nerve Neural Mobilization Adds No Additional Benefit When Combined with Cervical Lateral Glide in the Treatment of Neck Pain: A Randomized Clinical Trial.,"BACKGROUND


This study aimed to compare the effectiveness of cervical lateral glide (CLG) added to median nerve neural mobilization (MNNM) in patients with neck pain (NP).
METHODS


A single-blinded randomized controlled clinical trial was carried out in a Pain Management Unit from a Hospital. A total sample of 72 patients with NP was recruited from a hospital. Patients were randomized to receive isolated CLG ( n  = 36) or CLG + MNNM ( n  = 36). Bilateral elbow extension range of motion (ROM) on upper limb neurodynamic test 1 (ULNT1), bilateral pressure pain thresholds (PPT) on the median nerve at elbow joint, C 6  zygapophyseal joint and tibialis anterior, Visual analogue scale (VAS), body chart distribution of pain, active cervical ROM (CROM), Neck Disability Index (NDI), and Tampa Scale of Kinesiophobia (TSK-11) were measured at baseline as well as immediately, 15 days, and 1 month after treatment.
RESULTS


There were no statistically significant interactions ( p  > 0.05) between treatment and time for median nerve mechanosensitivity outcomes, pain intensity, symptom distribution, and PPT of the widespread pain assessment, as well as cervical function, and kinesiophobia.
CONCLUSIONS


MNNM gave no additional benefit to CLG in patients with NP regarding pain intensity, symptom distribution, mechanosensitivity, functionality, and kinesiophobia. Only two treatment sessions and the short follow-up are important issues, therefore, justifying further studies to answer the research question with better methodology.",2021,"There were no statistically significant interactions ( p  > 0.05) between treatment and time for median nerve mechanosensitivity outcomes, pain intensity, symptom distribution, and PPT of the widespread pain assessment, as well as cervical function, and kinesiophobia.
","['Pain Management Unit from a Hospital', 'Neck Pain', '72 patients with NP was recruited from a hospital', 'patients with neck pain (NP']","['CLG + MNNM', 'Cervical Lateral Glide', 'isolated CLG', 'cervical lateral glide (CLG) added to median nerve neural mobilization (MNNM']","['median nerve mechanosensitivity outcomes, pain intensity, symptom distribution, and PPT of the widespread pain assessment, as well as cervical function, and kinesiophobia', 'Bilateral elbow extension range of motion (ROM) on upper limb neurodynamic test 1 (ULNT1), bilateral pressure pain thresholds (PPT) on the median nerve at elbow joint, C 6  zygapophyseal joint and tibialis anterior, Visual analogue scale (VAS), body chart distribution of pain, active cervical ROM (CROM), Neck Disability Index (NDI), and Tampa Scale of Kinesiophobia (TSK-11', 'pain intensity, symptom distribution, mechanosensitivity, functionality, and kinesiophobia']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0025058', 'cui_str': 'Structure of median nerve'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0025058', 'cui_str': 'Structure of median nerve'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0422826', 'cui_str': 'Symptom distribution'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0446794', 'cui_str': 'Median nerve at elbow'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0224521', 'cui_str': 'Zygapophyseal joint structure'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",72.0,0.266069,"There were no statistically significant interactions ( p  > 0.05) between treatment and time for median nerve mechanosensitivity outcomes, pain intensity, symptom distribution, and PPT of the widespread pain assessment, as well as cervical function, and kinesiophobia.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martin-Vera', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, 28005 Madrid, Spain.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'Fernández-Carnero', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, 28606 Madrid, Spain.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, 28606 Madrid, Spain.'}, {'ForeName': 'Ibai', 'Initials': 'I', 'LastName': 'López-de-Uralde-Villanueva', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, 28606 Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Arribas-Romano', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Martínez-Lozano', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, 28005 Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pecos-Martín', 'Affiliation': 'Physiotherapy and Pain Research Center, General Foundation of the University of Alcalá, 28805 Madrid, Spain.'}]",Journal of clinical medicine,['10.3390/jcm10215178']
3102,34772367,Facilitating Perinatal Access to Resources and Support (PeARS): a feasibility study with external pilot of a novel intervention.,"BACKGROUND


Up to 50% of women in areas of high socio-economic deprivation are at risk of developing depressive symptoms in pregnancy. Feeling well supported, can facilitate good mental health perinatally. A brief, innovative intervention to facilitate access to support and resources was developed and tested. This included one antenatal and one postnatal session, each with three evidence-based components: i) support from a non-professional peer to enable a woman to identify her needs; ii) information about local community services and signposting; and iii) development of a personalised If-Then plan to access that support. The aims were to evaluate the intervention and research methods for feasibility and acceptability for perinatal women, maternity care providers and peers, and provide preliminary effectiveness indications.
METHODS


Pregnant women living in an area of high deprivation were recruited from community-based antenatal clinics and randomised to intervention or control condition (a booklet about local resources). Outcome measures included women's use of community services by 34 + weeks gestation and 6 months postnatally; mental health and wellbeing measures, and plan implementation. Interviews and focus groups were conducted with women participants, providers, and peers. Data were analysed using framework analysis. Recruitment and retention of peers and participants, intervention fidelity, and acceptability of outcome measures were recorded.
RESULTS


Peer facilitators could be recruited, trained, retained and provide the intervention with fidelity. One hundred twenty six women were recruited and randomised, 85% lived in the 1% most deprived UK areas. Recruitment constituted 39% of those eligible, improving to 54% after midwifery liaison. Sixty five percent were retained at 6 months postnatally. Women welcomed the intervention, and found it helpful to plan access to community services. Providers strongly supported the intervention philosophy and integrated this easily into services. The study was not powered to detect significant group differences but there were positive trends in community service use, particularly postnatally. No differences were evident in mental health and wellbeing.
CONCLUSIONS


This intervention was well received and easily integrated into existing services. Women living in highly deprived areas could be recruited, randomised and retained. Measures were acceptable. Peer facilitators were successfully trained and retained. Full effectiveness studies are warranted.",2021,"The study was not powered to detect significant group differences but there were positive trends in community service use, particularly postnatally.","['perinatal women, maternity care providers and peers', 'women participants, providers, and peers', 'Pregnant women living in an area of high deprivation were recruited from community-based antenatal clinics and randomised to', 'Women living in highly deprived areas', 'One hundred twenty six women were recruited and randomised, 85% lived in the 1% most deprived UK areas']","['Facilitating Perinatal Access to Resources and Support (PeARS', 'intervention or control condition (a booklet about local resources', 'three evidence-based components: i) support from a non-professional peer to enable a woman to identify her needs; ii) information about local community services and signposting; and iii) development of a personalised If-Then plan to access that support']","['Recruitment and retention of peers and participants, intervention fidelity, and acceptability of outcome measures', 'mental health and wellbeing', ""women's use of community services by 34\u2009+\u2009weeks gestation and 6\xa0months postnatally; mental health and wellbeing measures, and plan implementation""]","[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1634625', 'cui_str': '% live'}]","[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0330664', 'cui_str': 'Pyrus communis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0009482', 'cui_str': 'Community Services'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009482', 'cui_str': 'Community Services'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]",126.0,0.0833122,"The study was not powered to detect significant group differences but there were positive trends in community service use, particularly postnatally.","[{'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Slade', 'Affiliation': 'Institute of Population Health, University of Liverpool, Ground Floor Whelan Building, Brownlow Hill, Liverpool, L69 3GB, UK. pauline.slade@liverpool.ac.uk.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Dembinsky', 'Affiliation': 'Health Sciences Stirling, University of Stirling, Stirling, FK9 4LA, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Bristow', 'Affiliation': 'NIHR CLAHRC North West Coast, Department of Health Services Research, Institute of Psychology, Health and Society, University of Liverpool, Waterhouse Building, Brownlow street, Liverpool, L69 3GL, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Garthwaite', 'Affiliation': 'Liverpool City Council, 1 Municipal Buildings, Dale St, Liverpool, l2 2DH, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Mahdi', 'Affiliation': ""Liverpool Women's Hospital NHS Foundation Trust, Crown St, Liverpool, L8 7SS, UK.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'James', 'Affiliation': ""Head of Children's Health Improvement, Liverpool Public Health, Liverpool City Council Cunard Building, Water Street, Liverpool, L3 1DS, UK.""}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Population Health, University of Liverpool, Waterhouse Building, Brownlow street, Liverpool, L69 3GL, UK.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Downe', 'Affiliation': 'School of Community Health and Midwifery, University of Central Lancashire, Preston, PR1 2HE, UK.'}]",BMC pregnancy and childbirth,['10.1186/s12884-021-04112-w']
3103,34772353,Ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a multicenter single-arm trial.,"BACKGROUND


Cytotoxic chemotherapy combinations and targeted agents represent established treatment concepts in advanced pancreatic neuroendocrine tumors (PNETs). However, response rates, side effects and outcome data strongly vary among these therapeutic approaches. Head-to-head comparisons between chemo- and molecular therapies are missing and secondary resistances frequently occur. The RamuNET trial aims to identify the effectiveness of dual treatment with DTIC and ramucirumab in progressive advanced PNET patients.
METHODS


The RamuNET study is an investigator-initiated multicenter prospective single-arm trial to evaluate the efficacy of ramucirumab in combination with dacarbazine (DTIC) over a period of at least 6 months. Patients with progressive well-differentiated and metastatic pancreatic neuroendocrine tumors are eligible. The study aims to include 45 patients over a period of 24 months with a minimum follow-up of 24 months. The primary endpoint is disease control after 6 months. Secondary endpoints include progression-free survival, biochemical response, overall survival, quality of life and toxicity. Based on the hypothesis that 80% of the patients can achieve a disease control after 6 months, the sample size calculation follows an exact binomial single-stage design. H0: p < =p 0  = 60% versus H1: p > =p 1  = 80%, alpha = 0.05, beta = 0.1.
DISCUSSION


This study investigates a new therapeutic approach using the combination of cytotoxic and targeted antiangiogenic therapy in advanced PNET. If positive, this trial will be the basis for a randomized two-arm study to investigate the combination of ramucirumab and DTIC against other established therapies in PNET.
TRIAL REGISTRATION


EudraCT: 2017-001207-68 . Date of registration: 2018.01.03.",2021,"Secondary endpoints include progression-free survival, biochemical response, overall survival, quality of life and toxicity.","['patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET', 'progressive advanced PNET patients', '45 patients over a period of 24\u2009months with a minimum follow-up of 24\u2009months', 'Patients with progressive well-differentiated and metastatic pancreatic neuroendocrine tumors', 'advanced pancreatic neuroendocrine tumors (PNETs']","['dacarbazine (DTIC', 'cytotoxic and targeted antiangiogenic therapy', 'DTIC and ramucirumab', 'ramucirumab and DTIC', 'Ramucirumab', 'ramucirumab', 'dacarbazine']","['response rates, side effects', 'progression-free survival, biochemical response, overall survival, quality of life and toxicity', 'disease control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C2609093', 'cui_str': 'Pancreatic neuroendocrine tumour metastatic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0206663', 'cui_str': 'Primitive neuroectodermal tumor'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242363', 'cui_str': 'Pancreatic endocrine tumor'}]","[{'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.115275,"Secondary endpoints include progression-free survival, biochemical response, overall survival, quality of life and toxicity.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Krug', 'Affiliation': 'Department of Internal Medicine I, Martin-Luther University Halle/Wittenberg, Ernst-Grube-Str. 40, 06120, Halle (Saale), Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kegel', 'Affiliation': 'Department of Internal Medicine IV, Martin-Luther University Halle/Wittenberg, Halle, Germany.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gress', 'Affiliation': 'Department of Gastroenterology, Endocrinology and Metabolism, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rinke', 'Affiliation': 'Department of Gastroenterology, Endocrinology and Metabolism, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Leonidas', 'Initials': 'L', 'LastName': 'Apostolidis', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Jann', 'Affiliation': 'Department of Gastroenterology and Hepatology, Charité University Hospital, Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'König', 'Affiliation': 'Department of Gastroenterology and gastrointestinal Oncology, Georg-August University, Göttingen, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Hörsch', 'Affiliation': 'Department of Gastroenterology/Endocrinology, Center for Neuroendocrine Tumors Bad Berka, Bad Berka, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Schrader', 'Affiliation': 'Department of Medicine - Gastroenterology and Hepatology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ettrich', 'Affiliation': 'Department of Internal Medicine I, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Richter', 'Affiliation': 'Coordination Centre for Clinical Trials, Faculty of Medicine, Martin-Luther University Halle/Wittenberg, Halle, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Steighardt', 'Affiliation': 'Coordination Centre for Clinical Trials, Faculty of Medicine, Martin-Luther University Halle/Wittenberg, Halle, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Michl', 'Affiliation': 'Department of Internal Medicine I, Martin-Luther University Halle/Wittenberg, Ernst-Grube-Str. 40, 06120, Halle (Saale), Germany. patrick.michl@uk-halle.de.'}]",BMC cancer,['10.1186/s12885-021-08900-7']
3104,34772339,Investigating the effect of multimedia education in combination with teach-back method on quality of life and cardiac anxiety in patients with heart failure: a randomized clinical trial.,"BACKGROUND


Education can contribute to promotion of the quality of life and reduction of heart anxiety in patients with heart failure, so it is important to find a suitable educational method for these patients. Therefore, the present study was an attempt to determine the effect of multimedia education using teach-back method on the life quality and cardiac anxiety in patients with heart failure.
METHODS


The present study was a randomized clinical trial. 120 patients with heart failure class I to III and aged less than 60 years old were selected using sequential sampling; then, they were assigned randomly into two intervention groups and one control group. Group A (multimedia education), group B (education using multimedia together with teach-back method), and group C (control). The quality of life and cardiac anxiety were evaluated in the participants of the three groups before, after, 1 month, and 3 months after the intervention. Data were analyzed using descriptive tests, Pearson correlation, Kolmogorov-Smirnov, chi square and ANOVA test in SPSS 22. The significance level was set at P < 0.05.
RESULTS


No significant differences were found in the mean scores of the quality of life and cardiac anxiety in the control and two intervention groups before the educational intervention. However, immediately after, 1 month and 3 months after the educational intervention, a significant difference was observed between the mean scores of the quality of life and cardiac anxiety in the intervention groups (P < 0.05).
CONCLUSION


Multimedia education together with Teach-Back method is effective in promoting the quality of life and reducing cardiac anxiety in patients with heart failure. Therefore, it is recommended that health policymakers should use this educational method in providing treatment programs.
IRANIAN REGISTRY OF CLINICAL TRIALS


20190917044802N1. Registration date: 5/2/2020.",2021,No significant differences were found in the mean scores of the quality of life and cardiac anxiety in the control and two intervention groups before the educational intervention.,"['patients with heart failure', '120 patients with heart failure class I to III and aged less than 60\xa0years old']",['multimedia education in combination with teach-back method'],"['quality of life and reducing cardiac anxiety', 'life quality and cardiac anxiety', 'quality of life and cardiac anxiety', 'mean scores of the quality of life and cardiac anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0205297,No significant differences were found in the mean scores of the quality of life and cardiac anxiety in the control and two intervention groups before the educational intervention.,"[{'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Mohammadi', 'Affiliation': 'Chronic Diseases (Home Care) Research Center and Autism Spectrum Disorders Research Center, Department of Nursing, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mitra Sadeghi', 'Initials': 'MS', 'LastName': 'Jahromi', 'Affiliation': 'Department of Medical Surgical Nursing, Fasa University of Medical Sciences, 81936-13119, Fasa, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Bijani', 'Affiliation': 'Department of Medical Surgical Nursing, Fasa University of Medical Sciences, 81936-13119, Fasa, Iran. bizhani_mostafa@yahoo.com.'}, {'ForeName': 'Shanaz', 'Initials': 'S', 'LastName': 'Karimi', 'Affiliation': 'Department of Medical Surgical Nursing, Fasa University of Medical Sciences, 81936-13119, Fasa, Iran.'}, {'ForeName': 'Azizallah', 'Initials': 'A', 'LastName': 'Dehghan', 'Affiliation': 'NonCommunicable Diseases Research Center (NCDRC), Fasa University of Medical Sciences, Fasa, Iran.'}]",BMC cardiovascular disorders,['10.1186/s12872-021-02357-z']
3105,34772324,Tasting rewards. Effects of orosensory sweet signals on human error processing.,"Human research has shown interactions between rewards and cognitive control. In animal models of affective neuroscience, reward administration typically involves administering orosensory sugar signals (OSS) during caloric-deprived states. We adopted this procedure to investigate neurophysiological mechanisms of reward-cognitive control interactions in humans. We predicted that OSS would affect neurophysiological and behavioral indices of error processing oppositely, depending on the relative weight of the OSS-induced 'wanting' and 'liking' components of reward. We, therefore, conducted a double-blind, non-nutritive sweetener-controlled study with a within-subject design. Fasted (16 hr) participants ( N  = 61) performed a modified Flanker task to assess neurophysiological (error-related negativity [N e /ERN]) and behavioral (post-error adaptations) measures of error processing. Non-contingent to task performance, we repeatedly administered either a sugar (glucose) or non-nutritive sweetener (aspartame) solution, which had to be expulsed after short oral stimulation to prevent post-oral effects. Consistent with our hypothesis on how 'liking' would affect N e /ERN amplitude, we found the latter to be decreased for sugar compared to aspartame. Unexpectedly, we found post-error accuracy, instead of post-error slowing, to be reduced by sugar relative to aspartame. Our findings suggest that OSS may interact with error processing through the 'liking' component of rewards. Adopting our reward-induction procedure (i.e. administering OSS in a state of high reward sensitivity [i.e. fasting], non-contingent to task performance) might help future research investigating the neural underpinnings of reward-cognitive control interactions in humans.",2021,"Consistent with our hypothesis on how 'liking' would affect N e /ERN amplitude, we found the latter to be decreased for sugar compared to aspartame.",['humans'],"['orosensory sweet signals', 'OSS', 'sugar (glucose) or non-nutritive sweetener (aspartame) solution', 'modified Flanker task to assess neurophysiological (error-related negativity [N e /ERN]) and behavioral (post-error adaptations) measures of error processing']",['human error processing'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3658246', 'cui_str': 'High-Intensity Sweeteners'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]",,0.13113,"Consistent with our hypothesis on how 'liking' would affect N e /ERN amplitude, we found the latter to be decreased for sugar compared to aspartame.","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hosang', 'Affiliation': 'Experimental Psychology Unit, Faculty of Humanities and Social Sciences, Helmut Schmidt University/University of the Federal Armed Forces Hamburg, Hamburg, Germany.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Laborde', 'Affiliation': 'Department of Performance Psychology, Institute of Psychology, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sprengel', 'Affiliation': 'Experimental Psychology Unit, Faculty of Humanities and Social Sciences, Helmut Schmidt University/University of the Federal Armed Forces Hamburg, Hamburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Löw', 'Affiliation': 'Experimental Psychology Unit, Faculty of Humanities and Social Sciences, Helmut Schmidt University/University of the Federal Armed Forces Hamburg, Hamburg, Germany.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Baum', 'Affiliation': 'Department of Performance Psychology, Institute of Psychology, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Performance Psychology, Institute of Psychology, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jacobsen', 'Affiliation': 'Experimental Psychology Unit, Faculty of Humanities and Social Sciences, Helmut Schmidt University/University of the Federal Armed Forces Hamburg, Hamburg, Germany.'}]",Nutritional neuroscience,['10.1080/1028415X.2021.1993538']
3106,34772592,Comparison of Black and White participants with severe mental illness in response to cognitive remediation as an augmentation of vocational rehabilitation.,"PURPOSE


Despite evidence that cognitive remediation improves cognitive and employment outcomes in persons with severe mental illnesses (SMI), its effects have not been systematically compared between Black and White participants. Considering that Black adults have more negative experiences receiving mental health treatment, providers may have greater difficulty engaging and retaining Black Americans in cognitive remediation. Due to the effects of structural racism on reducing employment opportunities for Black Americans, it is unclear whether Black participants will reap the same benefits of cognitive remediation on work outcomes as White Americans. This paper addressed this question.
METHODS


A secondary analysis was conducted of five randomized controlled trials comparing cognitive remediation (the Thinking Skills for Work program: TSW) and vocational rehabilitation vs. vocational rehabilitation only in 137 Black and 147 White Americans (64.2% schizophrenia-schizoaffective disorder) who were followed up for two years.
RESULTS


Comparable proportions of Black and White participants were engaged and retained in TSW (>75%). Participants who received TSW improved significantly more in cognition than those receiving vocational services alone, with no racial differences in benefit. Participants in TSW obtained more work, earned more wages, and worked more weeks than those receiving vocational services alone, with no differences between the races.
CONCLUSIONS


The findings indicate that Black Americans with SMI receiving vocational services could be successfully engaged in and benefit from cognitive remediation, highlighting the vital role of healthcare service systems in giving credence to structural racism to more effectively mitigate racial disparities in treatment outcomes.",2021,"Participants who received TSW improved significantly more in cognition than those receiving vocational services alone, with no racial differences in benefit.","['Black and White participants with severe mental illness', 'Black adults', '137 Black and 147 White Americans (64.2% schizophrenia-schizoaffective disorder) who were followed up for two years', 'Black Americans with SMI receiving vocational services', 'Black Americans', 'persons with severe mental illnesses (SMI']","['structural racism', 'cognitive remediation', 'cognitive remediation (the Thinking Skills for Work program: TSW) and vocational rehabilitation vs. vocational rehabilitation', 'TSW']",['cognitive and employment outcomes'],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205905', 'cui_str': 'Racial Discrimination'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C4279942', 'cui_str': 'Thinking Skills'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034996', 'cui_str': 'Vocational rehabilitation'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",137.0,0.110756,"Participants who received TSW improved significantly more in cognition than those receiving vocational services alone, with no racial differences in benefit.","[{'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'DeTore', 'Affiliation': 'Massachusetts General Hospital, United States of America; Department of Psychiatry, Harvard Medical School, United States of America.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Balogun-Mwangi', 'Affiliation': 'Salve Regina University, United States of America.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Mueser', 'Affiliation': 'Center for Psychiatric Rehabilitation, Boston University, United States of America; Department of Occupational Therapy, Boston University, United States of America. Electronic address: mueser@bu.edu.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'McGurk', 'Affiliation': 'Center for Psychiatric Rehabilitation, Boston University, United States of America; Department of Occupational Therapy, Boston University, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2021.09.001']
3107,34772457,"Treatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE + ) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial.","BACKGROUND


Edema is commonly seen after surgical fixation of ankle fractures. Rest, ice, compression, and elevation (RICE) is an established combination to prevent swelling but hardly able to stimulate lymphatic resorption. Recently, an epicutaneously applied negative pressure suction apparatus (LymphaTouch®) has been introduced to stimulate lymphatic flow. While postoperative recovery, soft tissue, and osseous healing as well as functional outcome are probably linked to the amount of postoperative swelling, estimates on this relative to prevention (RICE) or prevention + stimulated resorption (RICE + ) of fluid are scarce.
METHODS AND ANALYSIS


This is a single-center, evaluator-blinded randomized pilot trial to investigate postoperative swelling in adults requiring surgical fixation of a closed unilateral ankle fracture. A total of 50 patients will be recruited and randomly assigned to RICE or RICE +  prior to surgery. All patients will undergo evaluator-blinded measurements of the ankle volume the day before surgery and subsequently from the evening of the 2nd postoperative day every 24 h until discharge. RICE will be initiated right after surgery and continued until discharge from the hospital in all patients. Additional application of negative pressure therapy (RICE + ) will be initiated on the morning of the 2nd postoperative day and repeated every 24 h until the time of discharge from the hospital. Outcome measures are (i) the relative amount and the time course of the postoperative swelling, (ii) the demand for analgesic therapy (type and amount) together with the perception of pain, (iii) the rate of complications, and (iv) mobility of the ankle joint and the recovery of walking abilities during a 12-weeks follow-up period. Serum and urine samples taken prior to sugery and during postoperative recovery will allow to evaluate the ratio of naturally occurring stable calcium isotopes (δ 44/42 Ca) as a marker of skeletal calcium accrual.
ETHICS AND DISSEMINATION


The protocol was approved by the institutional Ethics Committee (Rostock University Medical Center, Rostock, Germany) in accordance with the Declaration of Helsinki (approval number: A 2020-0092). The results of this study will be actively disseminated through scientific publications and conference presentations.
TRIAL REGISTRATION


DRKS, DRKS00023739 . Registered on 14 December 2020.",2021,"Outcome measures are (i) the relative amount and the time course of the postoperative swelling, (ii) the demand for analgesic therapy (type and amount) together with the perception of pain, (iii) the rate of complications, and (iv) mobility of the ankle joint and the recovery of walking abilities during a 12-weeks follow-up period.","['adults requiring surgical fixation of a closed unilateral ankle fracture', 'patients with a unilateral ankle fracture', '50 patients']","['perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE + ', 'RICE or RICE +  prior to surgery', 'negative pressure therapy (RICE + ', 'epicutaneously applied negative pressure suction apparatus (LymphaTouch®']","['Rest, ice, compression, and elevation (RICE', 'relative amount and the time course of the postoperative swelling, (ii) the demand for analgesic therapy (type and amount) together with the perception of pain, (iii) the rate of complications, and (iv) mobility of the ankle joint and the recovery of walking abilities', 'postoperative recovery, soft tissue, and osseous healing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",50.0,0.179413,"Outcome measures are (i) the relative amount and the time course of the postoperative swelling, (ii) the demand for analgesic therapy (type and amount) together with the perception of pain, (iii) the rate of complications, and (iv) mobility of the ankle joint and the recovery of walking abilities during a 12-weeks follow-up period.","[{'ForeName': 'Dagmar-C', 'Initials': 'DC', 'LastName': 'Fischer', 'Affiliation': 'Department of Pediatrics, Rostock University Medical Center, Ernst-Heydemann-Str. 8, 18057, Rostock, Germany. dagmar-christiane.fischer@med.uni-rostock.de.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Sckell', 'Affiliation': 'Department of Traumatology, Hand and Reconstructive Surgery, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Garkisch', 'Affiliation': 'Department of Traumatology, Hand and Reconstructive Surgery, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Dresing', 'Affiliation': 'Department of Trauma Surgery, Orthopaedics and Plastic Surgery, University Medicine Göttingen, Georg-August-University, Göttingen, Germany.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Eisenhauer', 'Affiliation': 'GEOMAR Helmholtz Center for Ocean Research Kiel, Kiel, Germany.'}, {'ForeName': 'Luzia', 'Initials': 'L', 'LastName': 'Valentini', 'Affiliation': 'Department of Agriculture and Food Sciences, Neubrandenburg Institute for Evidence-Based Dietetics (NIED), University of Applied Sciences Neubrandenburg, Neubrandenburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mittlmeier', 'Affiliation': 'Department of Traumatology, Hand and Reconstructive Surgery, Rostock University Medical Center, Rostock, Germany.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00944-7']
3108,34768500,"Ultrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial.","BACKGROUND


The purpose of this prospective study was to evaluate the efficacy and safety of the Ultrasound Cyclo Plasty (UCP) procedure using high-intensity focused ultrasound in surgery-naïve open-angle glaucoma patients.
METHODS


prospective, non-randomized, single-arm, multicenter clinical trial. Sixty-six eyes with primary open-angle glaucoma, intraocular pressure (IOP) ≥21 mmHg and with no history of filtering surgery were enrolled. Patients were treated by UCP with a therapy probe comprising six piezoelectric transducers, consecutively activated for 8 s each. Complete ophthalmic examination was performed before the procedure, 1 day after the procedure, and 1, 3, 6, 12, 18 and 24 months after the procedure. Primary outcomes were complete success (defined as IOP lowering from baseline ≥20% without additional glaucoma medications) and vision-threatening complications. Secondary outcomes were the presence of complications and the reduction of the number of medications used.
RESULTS


IOP was significantly reduced after one procedure ( p  < 0.05), from a mean pre-operative value of 24.3 ± 2.9 mmHg (n = 2.3 hypotensive medications) to a mean value of 15.9 ± 3.6 mmHg (n = 2.2 hypotensive medications) at 2 years (mean IOP lowering of 33%). Surgical success was achieved in 74% of eyes. Notwithstanding side effects such as transient anterior chamber inflammation, refractive error changes, transient hypotony and macular edema, no major intra or post-operative complications such as phthisis, induced cataract, neovascularization or significant vision loss were observed.
CONCLUSIONS


Ultrasound Cyclo Plasty is a valuable, effective and well-tolerated procedure to lower IOP in patients with open-angle glaucoma without previous filtering surgery.",2021,"Ultrasound Cyclo Plasty is a valuable, effective and well-tolerated procedure to lower IOP in patients with open-angle glaucoma without previous filtering surgery.","['Surgery-Naïve Open-Angle Glaucoma Patients', 'patients with open-angle glaucoma without previous filtering surgery', 'surgery-naïve open-angle glaucoma patients', 'Sixty-six eyes with primary open-angle glaucoma, intraocular pressure (IOP) ≥21 mmHg and with no history of filtering surgery were enrolled']","['Ultrasound Cyclo Plasty (UCP) procedure using high-intensity focused ultrasound', 'UCP', 'Ultrasound Cyclo Plasty']","['presence of complications and the reduction of the number of medications used', 'Surgical success', 'IOP', 'complete success (defined as IOP lowering from baseline ≥20% without additional glaucoma medications) and vision-threatening complications', 'efficacy and safety', 'transient anterior chamber inflammation, refractive error changes, transient hypotony and macular edema, no major intra or post-operative complications such as phthisis, induced cataract, neovascularization or significant vision loss']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0242673', 'cui_str': 'Surgery, Filtering'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441583', 'cui_str': 'High intensity focused ultrasound'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}]",66.0,0.0167636,"Ultrasound Cyclo Plasty is a valuable, effective and well-tolerated procedure to lower IOP in patients with open-angle glaucoma without previous filtering surgery.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Figus', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and of Critical Area, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Posarelli', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and of Critical Area, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Nardi', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and of Critical Area, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Stalmans', 'Affiliation': 'Department of Ophthalmology, University Hospital of UZ Leuven, 3001 Leuven, Belgium.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Vandewalle', 'Affiliation': 'Department of Ophthalmology, University Hospital of UZ Leuven, 3001 Leuven, Belgium.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Melamed', 'Affiliation': 'The Sam Rothberg Glaucoma Center, Goldschleger Eye Institute, Sheba Medical Center, Tel-Aviv University, Tel-Hashomer 52621, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Skaat', 'Affiliation': 'The Sam Rothberg Glaucoma Center, Goldschleger Eye Institute, Sheba Medical Center, Tel-Aviv University, Tel-Hashomer 52621, Israel.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Leshno', 'Affiliation': 'The Sam Rothberg Glaucoma Center, Goldschleger Eye Institute, Sheba Medical Center, Tel-Aviv University, Tel-Hashomer 52621, Israel.'}, {'ForeName': 'David Cordeiro', 'Initials': 'DC', 'LastName': 'Sousa', 'Affiliation': 'Department of Ophthalmology, Santa Maria Hospital, University of Lisbon, 1649-028 Lisbon, Portugal.'}, {'ForeName': 'Luis Abegão', 'Initials': 'LA', 'LastName': 'Pinto', 'Affiliation': 'Department of Ophthalmology, Santa Maria Hospital, University of Lisbon, 1649-028 Lisbon, Portugal.'}]",Journal of clinical medicine,['10.3390/jcm10214982']
3109,34768498,The Effect of Ultrasonic Agitation on the Porosity Distribution in Apically Perforated Root Canals Filled with Different Bioceramic Materials and Techniques: A Micro-CT Assessment.,"The present study evaluated the effect of ultrasonic agitation on the porosity distribution of BioRoot RCS/single gutta-percha cone (BR/SC) and MTA Flow (MF) root canals fillings used as apical plugs in moderately curved and apically perforated roots. Eighty mesial root canals of mandibular first molars were enlarged up to ProTaper NEXT X5 rotary instrument 2 mm beyond the apical foramen, simulating apical perforations. Specimens were randomly divided into four experimental groups (20 canals per group) according to the material and technique used for root canal obturation: BR/SC, BR/SC with ultrasonic agitation (BR/SC-UA), MF and MF with ultrasonic agitation (MF-UA). The ultrasonic tip was passively inserted into the root canal after the injection of flowable cement and activated for 10 s. The specimens were scanned before and after obturation with a high-resolution micro-computed tomography scanner, and the porosity of the apical plugs was assessed. The differences between groups were analyzed using the Kruskal-Wallis and Mann-Whitney tests, with the significance level set at 5%. None of the obturation materials and techniques used in this study was able to provide a pore-free root canal filling in the apical 5 mm. Considerably higher percentages of open and closed pores were observed in the MF and MF-UA groups, with the highest porosity being in the MF-UA group ( p  < 0.05). No significant differences were observed between the BR/SC and BR/SC-UA groups, where the quantity of open and closed pores remained similar ( p  > 0.05).",2021,None of the obturation materials and techniques used in this study was able to provide a pore-free root canal filling in the apical 5 mm.,"['Apically Perforated Root Canals Filled with Different Bioceramic Materials and Techniques', 'Eighty mesial root canals of mandibular first molars']","['material and technique used for root canal obturation: BR/SC, BR/SC with ultrasonic agitation (BR/SC-UA), MF and MF with ultrasonic agitation (MF-UA', 'ultrasonic agitation', 'Ultrasonic Agitation', 'BioRoot RCS/single gutta-percha cone (BR/SC) and MTA Flow (MF) root canals fillings']","['quantity of open and closed pores', 'Porosity Distribution']","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0447375', 'cui_str': 'Mesial tooth root'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0035848', 'cui_str': 'Root canal obturation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0440200', 'cui_str': 'Gutta percha cone'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0080037', 'cui_str': 'Porosity'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",,0.00892745,None of the obturation materials and techniques used in this study was able to provide a pore-free root canal filling in the apical 5 mm.,"[{'ForeName': 'Saulius', 'Initials': 'S', 'LastName': 'Drukteinis', 'Affiliation': 'Institute of Dentistry, Faculty of Medicine, Vilnius University, Zalgirio 115, LT-08217 Vilnius, Lithuania.'}, {'ForeName': 'Goda', 'Initials': 'G', 'LastName': 'Bilvinaite', 'Affiliation': 'Institute of Dentistry, Faculty of Medicine, Vilnius University, Zalgirio 115, LT-08217 Vilnius, Lithuania.'}, {'ForeName': 'Hagay', 'Initials': 'H', 'LastName': 'Shemesh', 'Affiliation': 'Academic Centre for Dentistry Amsterdam (ACTA), Gustav Mahlerlaan 3044, 1081 LA Amsterdam, The Netherlands.'}, {'ForeName': 'Paulius', 'Initials': 'P', 'LastName': 'Tusas', 'Affiliation': 'Institute of Dentistry, Faculty of Medicine, Vilnius University, Zalgirio 115, LT-08217 Vilnius, Lithuania.'}, {'ForeName': 'Vytaute', 'Initials': 'V', 'LastName': 'Peciuliene', 'Affiliation': 'Institute of Dentistry, Faculty of Medicine, Vilnius University, Zalgirio 115, LT-08217 Vilnius, Lithuania.'}]",Journal of clinical medicine,['10.3390/jcm10214977']
3110,34768487,"Six-Month Results on Treatment Adherence, Physical Activity, Spinal Appearance, Spinal Deformity, and Quality of Life in an Ongoing Randomised Trial on Conservative Treatment for Adolescent Idiopathic Scoliosis (CONTRAIS).","Adolescents with idiopathic scoliosis (AIS) often receive conservative treatments aiming to prevent progression of the spinal deformity during puberty. This study aimed to explore patient adherence and secondary outcomes during the first 6 months in an ongoing randomised controlled trial of three treatment interventions. Interventions consisted of physical activity combined with either hypercorrective Boston brace night shift (NB), scoliosis-specific exercise (SSE), or physical activity alone (PA). Measures at baseline and 6 months included angle of trunk rotation (ATR), Cobb angle, International Physical Activity Questionnaire short form (IPAQ-SF), pictorial Spinal Appearance Questionnaire (pSAQ), Scoliosis Research Society (SRS-22r), EuroQol 5-Dimensions Youth (EQ-5D-Y) and Visual Analogue Scale (EQ-VAS). Patient adherence, motivation, and capability in performing the intervention were reported at 6 months. The study included 135 patients (111 females) with AIS and >1-year estimated remaining growth, mean age 12.7 (1.4) years, and mean Cobb angle 31 (±5.3). At 6 months, the proportion of patients in the groups reporting high to very high adherence ranged between 72 and 95%, while motivation ranged between 65 and 92%, with the highest proportion seen in the NB group ( p  = 0.014,  p = 0.002). IPAQ-SF displayed significant between group main effects regarding moderate activity (F = 5.7;  p  = 0.004; η p 2  = 0.10), with a medium-sized increase favouring the SSE group compared to NB. Walking showed significant between group main effects, as did metabolic equivalent (MET-min/week), with medium (F = 6.8,  p  = 0.002; η p 2  = 0.11, and large (F = 8.3,  p  = < 0.001, η p 2  = 0.14) increases, respectively, for the SSE and PA groups compared to NB. From baseline to 6 months, ATR showed significant between group medium-sized main effects (F = 1.2,  p  = 0.019, η p 2  = 0.007) favouring the NB group compared to PA, but not reaching a clinically relevant level. In conclusion, patients reported high adherence and motivation to treatment, especially in the NB group. Patients in the SSE and PA groups increased their physical activity levels without other clinically relevant differences between groups in other clinical measures or patient-reported outcomes. The results suggest that the prescribed treatments are viable first-step options during the first 6 months.",2021,Patients in the SSE and PA groups increased their physical activity levels without other clinically relevant differences between groups in other clinical measures or patient-reported outcomes.,"['135 patients (111 females) with AIS and >1-year estimated remaining growth, mean age 12.7 (1.4) years, and mean Cobb angle 31 (±5.3', 'Adolescent Idiopathic Scoliosis (CONTRAIS', 'Adolescents with idiopathic scoliosis (AIS']","['physical activity combined with either hypercorrective Boston brace night shift (NB), scoliosis-specific exercise (SSE), or physical activity alone (PA', 'SSE']","['Patient adherence, motivation, and capability', 'angle of trunk rotation (ATR), Cobb angle, International Physical Activity Questionnaire short form (IPAQ-SF), pictorial Spinal Appearance Questionnaire (pSAQ), Scoliosis Research Society (SRS-22r), EuroQol 5-Dimensions Youth (EQ-5D-Y) and Visual Analogue Scale (EQ-VAS', 'Treatment Adherence, Physical Activity, Spinal Appearance, Spinal Deformity, and Quality of Life', 'physical activity levels', 'moderate activity']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0438891', 'cui_str': 'Boston brace'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0575157', 'cui_str': 'Deformity of spine'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",135.0,0.0499658,Patients in the SSE and PA groups increased their physical activity levels without other clinically relevant differences between groups in other clinical measures or patient-reported outcomes.,"[{'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Dufvenberg', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, SE 581 83 Linköping, Sweden.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Diarbakerli', 'Affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Orthopaedics and Biotechnology, Karolinska Institutet, SE 141 86 Stockholm, Sweden.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Charalampidis', 'Affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Orthopaedics and Biotechnology, Karolinska Institutet, SE 141 86 Stockholm, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Öberg', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, SE 581 83 Linköping, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Tropp', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, SE 581 83 Linköping, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Aspberg Ahl', 'Affiliation': 'Department of Orthopaedics, Ryhov County Hospital, SE 551 85 Jönköping, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Möller', 'Affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Orthopaedics and Biotechnology, Karolinska Institutet, SE 141 86 Stockholm, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gerdhem', 'Affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Orthopaedics and Biotechnology, Karolinska Institutet, SE 141 86 Stockholm, Sweden.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbott', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, SE 581 83 Linköping, Sweden.'}]",Journal of clinical medicine,['10.3390/jcm10214967']
3111,34768480,"Efficacy of a Preparation Based on Calcium Butyrate,  Bifidobacterium bifidum ,  Bifidobacterium lactis , and Fructooligosaccharides in the Prevention of Relapse in Ulcerative Colitis: A Prospective Observational Study.","Several compounds based on short chain fatty acids and/or probiotics/prebiotics have shown promising results in the therapy of ulcerative colitis (UC), possibly due to its key role in restoring gut homeostasis as well as intestinal barrier integrity. Here, we investigated the efficacy of a patented preparation based on calcium butyrate,  Bifidobacterium bifidum ,  Bifidobacterium lactis , and fructooligosaccharides (FEEDColon ® , Princeps, Cuneo, Italy) in maintaining remission and improving subjective symptoms and inflammatory indices in patients with UC receiving 5-ASA therapy. A total of 42 patients were prospectively recruited and randomized in 21 patients receiving combination therapy with mesalamine (5-ASA) plus FEEDColon ®  and 21 patients treated with standard 5-ASA therapy. Patients were assessed at baseline, at 6-month, and 12-month follow-up (FU). Therapeutic success (defined as Mayo partial score ≤ 2 and faecal calprotectin (FC) < 250 µg/g at 12-month FU) was reached by 32 (76%) patients: 20 (95%) among those treated with 5-ASA + FeedColon ® , and 12 (57%) among those treated with 5-ASA only ( p  = 0.009). Consistently, patients treated with combination therapy improved subjective symptoms (quality of life, abdominal pain, and stool consistency) and reduced FC values, while those treated with 5-ASA alone, improved neither subjective symptoms nor FC during the FU. In conclusion, FEEDColon ®  supplementation appears to be a valid add-on therapy for the maintenance of remission in patients with UC. Further multicentre, placebo-controlled, double-blind clinical trials are needed to validate our results on larger cohorts of patients with UC.",2021,"Therapeutic success (defined as Mayo partial score ≤ 2 and faecal calprotectin (FC) < 250 µg/g at 12-month FU) was reached by 32 (76%) patients: 20 (95%) among those treated with 5-ASA + FeedColon ® , and 12 (57%) among those treated with 5-ASA only ( p  = 0.009).","['patients with UC receiving 5-ASA therapy', 'Ulcerative Colitis', 'patients with UC', 'A total of 42 patients were prospectively recruited and randomized in 21 patients receiving']","['calcium butyrate,  Bifidobacterium bifidum ,  Bifidobacterium lactis , and fructooligosaccharides (FEEDColon ® , Princeps, Cuneo, Italy', 'combination therapy with mesalamine (5-ASA) plus FEEDColon ®', 'standard 5-ASA therapy', 'Calcium Butyrate,  Bifidobacterium bifidum ,  Bifidobacterium lactis , and Fructooligosaccharides', 'FEEDColon ®  supplementation', 'placebo', '5-ASA']","['subjective symptoms nor FC', 'subjective symptoms (quality of life, abdominal pain, and stool consistency) and reduced FC values', 'Mayo partial score ≤ 2 and faecal calprotectin (FC', 'Therapeutic success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",42.0,0.0293746,"Therapeutic success (defined as Mayo partial score ≤ 2 and faecal calprotectin (FC) < 250 µg/g at 12-month FU) was reached by 32 (76%) patients: 20 (95%) among those treated with 5-ASA + FeedColon ® , and 12 (57%) among those treated with 5-ASA only ( p  = 0.009).","[{'ForeName': 'Gian Paolo', 'Initials': 'GP', 'LastName': 'Caviglia', 'Affiliation': 'Department of Medical Sciences, University of Turin, 10124 Turin, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'De Blasio', 'Affiliation': 'Clinic of Gastroenterology, Department of Gastroenterology and Transplantation, Università Politecnica delle Marche, Ospedali Riuniti di Ancona, 60126 Ancona, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vernero', 'Affiliation': 'Department of Internal Medicine, San Matteo Hospital, 27100 Pavia, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Armandi', 'Affiliation': 'Department of Medical Sciences, University of Turin, 10124 Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Rosso', 'Affiliation': 'Department of Medical Sciences, University of Turin, 10124 Turin, Italy.'}, {'ForeName': 'Giorgio Maria', 'Initials': 'GM', 'LastName': 'Saracco', 'Affiliation': 'Department of Medical Sciences, University of Turin, 10124 Turin, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Bugianesi', 'Affiliation': 'Department of Medical Sciences, University of Turin, 10124 Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Astegiano', 'Affiliation': 'Unit of Gastroenterology, Città della Salute e della Scienza di Torino-Molinette Hospital, 10126 Turin, Italy.'}, {'ForeName': 'Davide Giuseppe', 'Initials': 'DG', 'LastName': 'Ribaldone', 'Affiliation': 'Department of Medical Sciences, University of Turin, 10124 Turin, Italy.'}]",Journal of clinical medicine,['10.3390/jcm10214961']
3112,34769633,Reduction in Pain and Pain Intensity with Nonpharmacological Treatment in Severely Obese Patients: A Randomized Clinical Trial.,"The objective of this study was to analyze the effectiveness of two nonpharmacological interventions-traditional Brazilian diet (DieTBra), and extra-virgin olive oil (EVOO)-in terms of the reduction in pain and pain intensity in individuals with severe obesity. We conducted a 12-week parallel randomized clinical trial with 149 individuals (body mass index (BMI) ≥ 35 kg/m 2 ) who were randomized into three groups: supplementation with EVOO ( n  = 50), DieTBra ( n  = 49), and EVOO + DieTBra ( n  = 50). Of the total, 133 individuals with a mean BMI of 46.04 kg/m 2  completed the study. By the end of the follow-up, there was a reduction in severe pain in the EVOO + DieTBra group ( p  = 0.003). There was a significant reduction in severe pain in the EVOO + DieTBra group (-22.7%); pain in the wrist and hand (-14.1%), upper back (-26.9%), and knees (-18.4%) in the DieTBra group; and reduction in hip pain (-11.1%) with EVOO consumption. We conclude that EVOO and DieTBra, either alone or in combination, are effective interventions to reduce pain intensity and pain in different regions in individuals with severe obesity, and have great potential for clinical application.",2021,"There was a significant reduction in severe pain in the EVOO + DieTBra group (-22.7%); pain in the wrist and hand (-14.1%), upper back (-26.9%), and knees (-18.4%) in the DieTBra group; and reduction in hip pain (-11.1%) with EVOO consumption.","['individuals with severe obesity', '149 individuals (body mass index (BMI) ≥ 35 kg/m 2 ', 'Severely Obese Patients', '133 individuals with a mean BMI of 46.04 kg/m 2  completed the study']","['nonpharmacological interventions-traditional Brazilian diet (DieTBra), and extra-virgin olive oil (EVOO)-in', 'supplementation with EVOO']","['severe pain', 'pain', 'pain intensity and pain', 'hip pain', 'Pain and Pain Intensity', 'pain and pain intensity', 'upper back']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0230101', 'cui_str': 'Upper back structure'}]",133.0,0.110368,"There was a significant reduction in severe pain in the EVOO + DieTBra group (-22.7%); pain in the wrist and hand (-14.1%), upper back (-26.9%), and knees (-18.4%) in the DieTBra group; and reduction in hip pain (-11.1%) with EVOO consumption.","[{'ForeName': 'Carolina Rodrigues', 'Initials': 'CR', 'LastName': 'Mendonça', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74650-050, GO, Brazil.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Noll', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74650-050, GO, Brazil.'}, {'ForeName': 'Camila Kellen de Souza', 'Initials': 'CKS', 'LastName': 'Cardoso', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74650-050, GO, Brazil.'}, {'ForeName': 'Annelisa Silva Alves de Carvalho', 'Initials': 'ASAC', 'LastName': 'Santos', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74650-050, GO, Brazil.'}, {'ForeName': 'Ana Paula Dos Santos', 'Initials': 'APDS', 'LastName': 'Rodrigues', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74650-050, GO, Brazil.'}, {'ForeName': 'Erika Aparecida', 'Initials': 'EA', 'LastName': 'Silveira', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74650-050, GO, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph182111112']
3113,34769571,The Influence of Robot-Assisted Learning System on Health Literacy and Learning Perception.,"Healthy aging is a new challenge for the world. Therefore, health literacy education is a key issue in the current health care field. This research has developed a robot-assisted learning system to explore the possibility of significantly improving health literacy and learning perception through interaction with robots. In particular, this study adopted an experimental design, in which the experiment lasted for 90 min. A total of 60 participants over the age of 50 were randomly assigned to different learning modes. The RobotLS group learned by interacting with robots, while the VideoLS group watched health education videos on a tablet computer. The content dealt with hypertension related issues. This study used the European Health Literacy Survey Questionnaire (HLS-EU-Q16), Health Knowledge Questionnaire, Reduced Instructional Materials Motivation Survey (RIMMS), and Flow Scale as evaluation tools. The result shows no significant difference in the pre-test scores between the two groups. Compared with the video-assisted learning system, the robot-assisted learning system can significantly improve health knowledge, health literacy, learning motivation, and flow perception. According to the findings of this study, a robot-assisted learning system can be introduced in the future into homes and care institutions to enhance the health literacy of the elderly.",2021,"Compared with the video-assisted learning system, the robot-assisted learning system can significantly improve health knowledge, health literacy, learning motivation, and flow perception.",['60 participants over the age of 50'],"['robot-assisted learning system', 'video-assisted learning system, the robot-assisted learning system', 'VideoLS group watched health education videos', 'Robot-Assisted Learning System']","['European Health Literacy Survey Questionnaire (HLS-EU-Q16), Health Knowledge Questionnaire, Reduced Instructional Materials Motivation Survey (RIMMS), and Flow Scale', 'pre-test scores', 'health knowledge, health literacy, learning motivation, and flow perception', 'Health Literacy and Learning Perception']","[{'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",60.0,0.0213883,"Compared with the video-assisted learning system, the robot-assisted learning system can significantly improve health knowledge, health literacy, learning motivation, and flow perception.","[{'ForeName': 'Chun-Wang', 'Initials': 'CW', 'LastName': 'Wei', 'Affiliation': 'Department of Healthcare Administration and Medical Informatics, Kaohsiung Medical University, Kaohsiung City 80708, Taiwan.'}, {'ForeName': 'Hao-Yun', 'Initials': 'HY', 'LastName': 'Kao', 'Affiliation': 'Department of Healthcare Administration and Medical Informatics, Kaohsiung Medical University, Kaohsiung City 80708, Taiwan.'}, {'ForeName': 'Wen-Hsiung', 'Initials': 'WH', 'LastName': 'Wu', 'Affiliation': 'Department of Healthcare Administration and Medical Informatics, Kaohsiung Medical University, Kaohsiung City 80708, Taiwan.'}, {'ForeName': 'Chien-Yu', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Healthcare Administration and Medical Informatics, Kaohsiung Medical University, Kaohsiung City 80708, Taiwan.'}, {'ForeName': 'Hsin-Pin', 'Initials': 'HP', 'LastName': 'Fu', 'Affiliation': 'Department of Marketing and Distribution Management, National Kaohsiung University of Science and Technology, Kaohsiung City 824005, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph182111053']
3114,34769561,Physical Activity through a Classroom-Based Intervention: A Pragmatic Non-Randomized Trial among Swedish Adolescents in an Upper Secondary School.,"Schools are an important arena to curb the decline in physical activity (PA) in youth. School-based interventions with accelerometer-measured PA are warranted. This study aimed to increase accelerometer-measured PA in adolescents following a 12-month school-based intervention. Two school-classes of 16-18-year-old Swedish students were allocated to intervention group and control group. Accelerometer-measured PA was gathered at baseline, 6- and 12-month follow-up. Mixed-effects linear regression was used to investigate between-group and within-group differences in mean minutes per day (min/day) of moderate to vigorous PA (MVPA), light PA (LPA) and sedentary time (ST). Fifty-seven students participated (intervention group = 31, control group = 26). At 12-month follow-up, the intervention group performed 5.9 (95% CI: -4.3, 16.2) min/day more in MVPA, 1.8 (95% CI: -17.9, 14.2) min/day less in LPA, and 4.1 (95% CI: -27.3, 19.2) min/day less in ST compared to the control group. Within the intervention group, there was no significant change in PA. Within the control group, LPA decreased (95% CI: -19.6, -0.2;  p  = 0.044) and ST increased (95% CI: 1.8, 30.8;  p  = 0.028). Although no between-group differences in PA were statistically significant, the within-group changes may suggest a preventive impact on the decline in PA during adolescence.",2021,"Within the control group, LPA decreased (95% CI: -19.6, -0.2;  p  = 0.044) and ST increased (95% CI: 1.8, 30.8;  p  = 0.028).","['Swedish Adolescents in an Upper Secondary School', 'adolescents following a 12-month school-based intervention', 'Two school-classes of 16-18-year-old Swedish students', 'Fifty-seven students participated (intervention group = 31, control group = 26']","['intervention group and control group', 'Physical Activity through a Classroom-Based Intervention']","['LPA', 'ST', 'moderate to vigorous PA (MVPA), light PA (LPA) and sedentary time (ST', 'PA']","[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1096202', 'cui_str': 'Lipoprotein (a) measurement'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",57.0,0.0295273,"Within the control group, LPA decreased (95% CI: -19.6, -0.2;  p  = 0.044) and ST increased (95% CI: 1.8, 30.8;  p  = 0.028).","[{'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Christiansen', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Viktor H', 'Initials': 'VH', 'LastName': 'Ahlqvist', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Nyroos', 'Affiliation': 'Department of Education, Umeå University, 901 87 Umeå, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Löfgren', 'Affiliation': 'Department of the Police Education Unit, Umeå University, 901 87 Umeå, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Berglind', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph182111041']
3115,34769545,The Efficacy of a Calamansi-Containing Energy Drink on Running Performance and Recovery in NCAA Division I Middle-Distance Runners: A Preliminary Study.,"This study examined the effects of a non-caffeinated energy drink (ED) that contained calamansi juice, glucose, and taurine on 3-km running performance and recovery. Eleven NCAA Division I middle-distance runners (20.8 ± 1.5 years old) were randomly assigned to consume either the ED or a placebo drink 60 min before 3-km running on a 400-m official track. Performance time and speed were recorded every 500-m interval. Recovery blood lactate concentration (BLC), systolic (SBP), diastolic blood pressure (DBP), and heart rate (HR) were measured at baseline, 60-min after ingesting the drinks, and post-running measurements were performed at 1-min, 5-min, and 10-min. Repeated analysis of variance and paired  t -test were applied to examine the effects of time, trials, and their interaction on performance and recovery. Statistical significance was set a priori at  p <  0.05. No significant difference was observed in performance time and speed between trials ( p <  0.05). No interaction effect was found on performance time, speed, recovery BLC, DBP, and HR ( p <  0.05). However, an interaction effect for trial by time was observed on SBP ( p  = 0.01). Recovery SBP continues to decrease from 5-min to 10-min in the ED trial (∆ = -13.9 mmHg) and slightly increased in the placebo trial (∆ = 1.1 mmHg). This study suggests that acute consumption of a calamansi-containing ED can positively impact the SBP recovery but not running performance. Further studies are needed to examine the acute and chronic effects of this ED on exercise performance and recovery among different populations.",2021,"No interaction effect was found on performance time, speed, recovery BLC, DBP, and HR ( p <  0.05).","['Middle-Distance Runners', 'I middle-distance runners (20.8 ± 1.5 years old', 'Eleven NCAA Division']","['non-caffeinated energy drink (ED) that contained calamansi juice, glucose, and taurine', 'placebo drink 60 min before 3-km running on a 400-m official track', 'Calamansi-Containing Energy Drink']","['Performance time and speed', 'Running Performance and Recovery in NCAA Division', 'performance time and speed', 'Recovery SBP', 'SBP', 'Recovery blood lactate concentration (BLC), systolic (SBP), diastolic blood pressure (DBP), and heart rate (HR', 'SBP recovery', 'performance time, speed, recovery BLC, DBP, and HR']","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1293097', 'cui_str': 'Division'}]","[{'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0040594', 'cui_str': 'Track'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.1678,"No interaction effect was found on performance time, speed, recovery BLC, DBP, and HR ( p <  0.05).","[{'ForeName': 'Abdullah B', 'Initials': 'AB', 'LastName': 'Alansare', 'Affiliation': 'Department of Exercise Physiology, College of Sport Sciences and Physical Activity, King Saud University, King Khalid Rd., Riyadh 11543, Saudi Arabia.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Hayman', 'Affiliation': 'Athletic Department, Mercer University, 1501 Mercer University Dr., Macon, GA 31207, USA.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Education, College of Physical Education, Kyung Hee University, Global Campus, 1732 Deokyoungdaero, Giheung-gu, Yongin-si 17014, Korea.'}, {'ForeName': 'Myong-Won', 'Initials': 'MW', 'LastName': 'Seo', 'Affiliation': 'Department of Exercise Science, David B. Falk College of Sport and Human Dynamics, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'Deoksu', 'Initials': 'D', 'LastName': 'Yoo', 'Affiliation': 'Department of Taekwondo, College of Physical Education, Kyung Hee University, 1732 Deokyoungdaero, Giheung-gu, Yongin-si 17014, Korea.'}, {'ForeName': 'Hyun Chul', 'Initials': 'HC', 'LastName': 'Jung', 'Affiliation': 'Department of Coaching, College of Physical Education, Kyung Hee University, Global Campus, 1732 Deokyoungdaero, Giheung-gu, Yongin-si 17014, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph182111023']
3116,34769434,Synergistic Effect in Neurological Recovery via Anti-Apoptotic Akt Signaling in Umbilical Cord Blood and Erythropoietin Combination Therapy for Neonatal Hypoxic-Ischemic Brain Injury.,"Our previous clinical studies demonstrated the synergistic therapeutic effect induced by co-administering recombinant human erythropoietin (rhEPO) in human umbilical cord blood (hUCB) therapy for children with cerebral palsy. However, the cellular mechanism beyond the beneficial effects in this combination therapy still needs to be elucidated. A hypoxic-ischemic encephalopathy (HIE) model of neonates, representing cerebral palsy, was prepared and randomly divided into five groups (hUCB+rhEPO combination, hUCB, and rhEPO treatments over HIE, HIE control, and sham). Seven days after, hUCB was administered intraperitoneally and the rhEPO injections were started. Neurobehavioral tests showed the best outcome in the combination therapy group, while the hUCB and rhEPO alone treatments also showed better outcomes compared with the control ( p  < 0.05). Inflammatory cytokines were downregulated by the treatments and attenuated most by the combination therapy ( p  < 0.05). The hUCB+rhEPO treatment also showed remarkable increase in phosphorylation of Akt and potentiation of anti-apoptotic responses with decreased Bax and increased Bcl-2 ( p  < 0.05). Pre-treatment of MK-2206, an Akt inhibitor, for the combination therapy depressed the anti-apoptotic effects. In conclusion, these findings suggest that the therapeutic effect of hUCB therapy might be potentiated by co-administration of rhEPO via augmentation of anti-inflammatory and anti-apoptotic responses related to the phosphorylation of Akt.",2021,Inflammatory cytokines were downregulated by the treatments and attenuated most by the combination therapy ( p  < 0.05).,"['neonates, representing cerebral palsy', 'Neonatal Hypoxic-Ischemic Brain Injury', 'children with cerebral palsy']","['recombinant human erythropoietin (rhEPO', 'MK-2206', 'Erythropoietin Combination Therapy', 'hUCB+rhEPO', 'hUCB+rhEPO combination, hUCB, and rhEPO treatments over HIE, HIE control, and sham', 'hUCB']","['Inflammatory cytokines', 'phosphorylation of Akt and potentiation of anti-apoptotic responses with decreased Bax and increased Bcl-2', 'Neurobehavioral tests']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C2933427', 'cui_str': 'MK 2206'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}, {'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0219474', 'cui_str': 'Bax Protein'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0376515', 'cui_str': 'bcl-2 Genes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0270567,Inflammatory cytokines were downregulated by the treatments and attenuated most by the combination therapy ( p  < 0.05).,"[{'ForeName': 'Jee In', 'Initials': 'JI', 'LastName': 'Choi', 'Affiliation': 'Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}, {'ForeName': 'Joo-Wan', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Rehabilitation and Regeneration Research Center, CHA University School of Medicine, Seongnam 13488, Korea.'}, {'ForeName': 'Kyu-Ho', 'Initials': 'KH', 'LastName': 'Shim', 'Affiliation': 'Rehabilitation and Regeneration Research Center, CHA University School of Medicine, Seongnam 13488, Korea.'}, {'ForeName': 'Jin Seung', 'Initials': 'JS', 'LastName': 'Choung', 'Affiliation': 'Rehabilitation and Regeneration Research Center, CHA University School of Medicine, Seongnam 13488, Korea.'}, {'ForeName': 'Hyun-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Rehabilitation and Regeneration Research Center, CHA University School of Medicine, Seongnam 13488, Korea.'}, {'ForeName': 'Hye Ryeong', 'Initials': 'HR', 'LastName': 'Sim', 'Affiliation': 'Rehabilitation and Regeneration Research Center, CHA University School of Medicine, Seongnam 13488, Korea.'}, {'ForeName': 'Mi Ri', 'Initials': 'MR', 'LastName': 'Suh', 'Affiliation': 'Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}, {'ForeName': 'Joo Eun', 'Initials': 'JE', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, University of Texas Health Science Center at Houston, McGovern Medical School, Houston, TX 77030, USA.'}, {'ForeName': 'MinYoung', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}]",International journal of molecular sciences,['10.3390/ijms222111995']
3117,34769906,The Effects of Elastic Band Exercises with PNF on Shooting Speed and Accuracy in Ball Hockey Players during the COVID-19 Pandemic.,"The coronavirus pandemic has affected life and left one of the strongest negative effects on sport. The aim of our study was to evaluate how a simple exercise performed with elastic resistance during the COVID-19 pandemic, when athletes cannot train, affects the basic shooting characteristics of ball hockey players. Extra-league ball hockey players ( N  = 30, age 19-37 years) were randomly divided into an experimental group, which performed elastic resistance exercises with Proprioceptive Neuromuscular Facilitation (PNF) elements for eight weeks, and a control group, which did not perform any exercises. Before the start of the experiment and after it was completed, the speed and accuracy of shooting were measured. In experimental group, there was no decrease after 8 weeks in the shooting speed, and in the control group, there was a statistically significant decrease. There was a deterioration in the accuracy of shooting in both groups; however, in the experimental group, the deterioration was not significant. The results show that even three simple exercises with elastic resistance according to the PNF concept performed 10 times per day for eight weeks can maintain the level of basic skills of ball hockey players-the speed and accuracy of shooting-even when no other training is performed.",2021,"There was a deterioration in the accuracy of shooting in both groups; however, in the experimental group, the deterioration was not significant.","['Extra-league ball hockey players ( N  = 30, age 19-37 years', 'Ball Hockey Players during the COVID-19 Pandemic']","['Elastic Band Exercises with PNF', 'elastic resistance exercises with Proprioceptive Neuromuscular Facilitation (PNF) elements for eight weeks, and a control group, which did not perform any exercises']","['shooting speed', 'accuracy of shooting', 'speed and accuracy of shooting', 'Shooting Speed and Accuracy']","[{'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0016074', 'cui_str': 'Field hockey'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1444774', 'cui_str': 'Shooting sensation quality'}]",,0.0298964,"There was a deterioration in the accuracy of shooting in both groups; however, in the experimental group, the deterioration was not significant.","[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Pavlů', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, 16252 Prague, Czech Republic.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Škripková', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, 16252 Prague, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pánek', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, 16252 Prague, Czech Republic.'}]",International journal of environmental research and public health,['10.3390/ijerph182111391']
3118,34769896,Effects of a 12-Week Recreational Skiing Program on Cardio-Pulmonary Fitness in the Elderly: Results from the Salzburg Skiing in the Elderly Study (SASES).,"OBJECTIVES


To investigate whether recreational alpine skiing in the elderly can improve cardio-pulmonary fitness.
DESIGN


Randomized controlled study with pre-post repeated measurements.
METHODS


A total of 48 elderly participants (60-76 years) were randomly assigned to either participate in a 12-week guided recreational skiing program (intervention group, IG, average of 28.5 ± 2.6 skiing days) or to continue a sedentary ski-free lifestyle (control group, CG). Cardio-pulmonary exercise testing (CPET) and pulmonary function testing were performed in both groups before (PRE) and after (POST) the intervention/control period to compare parameters PRE vs. POST CPET.
RESULTS


At baseline, IG and CG did not differ significantly with respect to CPET and pulmonary function parameters. At POST, several measures of maximal exercise capacity and breathing economy were significantly improved in IG as compared to CG: maximal oxygen capacity (IG: 33.8 ± 7.9; CG: 28.7 ± 5.9 mL/min/kg;  p  = 0.030), maximal carbon dioxide production (IG: 36.2 ± 7.7; CG: 31.8 ± 6.5 mL/min/kg;  p  = 0.05), maximal oxygen pulse (IG: 16.8 ± 4.2; CG: 13.2 ± 4 mL/heart beat;  p  = 0.010), maximal minute ventilation (IG: 96.8 ± 17.8; CG: 81.3 ± 21.9 l/min;  p  = 0.025), and maximal metabolic equivalent of task (METs, IG: 9.65 ± 2.26; CG: 8.19 ± 1.68 METs;  p  = 0.029). Except for oxygen pulse, these significant changes could also be observed at the anaerobic threshold. Maximal heart rate and pulmonary function parameters remained essentially unchanged.
CONCLUSION


Regular recreational skiing improves cardio-pulmonary fitness along with breathing economy and thus can contribute to a heart-healthy lifestyle for the elderly.",2021,"At POST, several measures of maximal exercise capacity and breathing economy were significantly improved in IG as compared to CG: maximal oxygen capacity (IG: 33.8 ± 7.9; CG: 28.7 ± 5.9 mL/min/kg;  p  = 0.030), maximal carbon dioxide production (IG: 36.2 ± 7.7; CG: 31.8 ±","['the Elderly', '48 elderly participants (60-76 years']","['Regular recreational skiing', '12-Week Recreational Skiing Program', 'recreational alpine skiing', 'Cardio-pulmonary exercise testing (CPET', 'guided recreational skiing program (intervention group, IG, average of 28.5 ± 2.6 skiing days) or to continue a sedentary ski-free lifestyle (control group, CG']","['cardio-pulmonary fitness', 'maximal oxygen pulse', 'Cardio-Pulmonary Fitness', 'maximal exercise capacity and breathing economy', 'Maximal heart rate and pulmonary function parameters', 'maximal minute ventilation', 'maximal carbon dioxide production']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0037264', 'cui_str': 'Skiing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0037262', 'cui_str': 'SKI'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]",48.0,0.0267253,"At POST, several measures of maximal exercise capacity and breathing economy were significantly improved in IG as compared to CG: maximal oxygen capacity (IG: 33.8 ± 7.9; CG: 28.7 ± 5.9 mL/min/kg;  p  = 0.030), maximal carbon dioxide production (IG: 36.2 ± 7.7; CG: 31.8 ±","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, University of Zurich, 8091 Zurich, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Walser', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, University of Zurich, 8091 Zurich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmied', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, University of Zurich, 8091 Zurich, Switzerland.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Dela', 'Affiliation': 'Department of Geriatrics, Bispebjerg-Frederiksberg University Hospital, DK-2400NV Copenhagen, Denmark.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Gräni', 'Affiliation': 'Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Bohm', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, University of Zurich, 8091 Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Müller', 'Affiliation': 'Department of Sport Science and Kinesiology, University of Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}]",International journal of environmental research and public health,['10.3390/ijerph182111378']
3119,34769859,Tele-Yoga in Long Term Illness-Protocol for a Randomised Controlled Trial Including a Process Evaluation and Results from a Pilot Study.,"BACKGROUND


For people with long-term illness, debilitated by severe symptoms, it can be difficult to attend regular yoga classes. We have therefore developed a tele-health format of yoga that can be delivered in the home. The tele-yoga was co-designed with members of a patient-organisation, yoga-instructor, and IT-technician. It includes live-streamed group-yoga sessions twice a week and an app with instructions on how to self-perform yoga.
AIM


To describe a study protocol for a randomised controlled trial (RCT) including a process evaluation and report on a pilot study evaluating method- and intervention-related components including feasibility, safety, and efficacy.
METHODS


Ten participants with heart failure aged between 41-76 years were randomised to tele-yoga ( n  = 5) or to the control group ( n  = 5). In the pilot study recruitment, enrolment, randomisation, and data collection of all outcomes including primary, secondary and process evaluation measures were tested according to the study protocol. Fidelity, adherence and acceptability to the tele-yoga group training and app use was determined. Safety was assessed by adverse events.
RESULTS


The pilot revealed that the methodological aspect of the protocol worked sufficiently in all aspects except for missing data in the physical test of two participants and one participant in the control-group that dropped out of the study at three months follow-up. The tele-yoga training did not lead to any adverse events or injuries, adherence of tele-yoga was sufficient according to preset limits. The tele-yoga intervention also showed some favourable trends of improvements in the composite-end point compared to the active control group. However, since data only was presented descriptively due to the small sample size, the impact of these trends should be interpreted carefully.
CONCLUSION


Our pilot study showed promising results in feasibility, safety, and acceptability of the tele-yoga intervention. Some changes in the protocol have been made to decrease the risk of missing data in the measures of physical function and in the full-scale RCT now ongoing the results of the sample size calculation for 300 participants have included the estimated level of drop outs and missing data.",2021,"The tele-yoga training did not lead to any adverse events or injuries, adherence of tele-yoga was sufficient according to preset limits.","['Ten participants with heart failure aged between 41-76 years', '300 participants']","['tele-yoga', 'Tele-Yoga']","['feasibility, safety, and acceptability', 'feasibility, safety, and efficacy', 'Fidelity, adherence and acceptability', 'Safety', 'adverse events or injuries, adherence of tele-yoga']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]",10.0,0.0604047,"The tele-yoga training did not lead to any adverse events or injuries, adherence of tele-yoga was sufficient according to preset limits.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Strömberg', 'Affiliation': 'Department of Health Medicine and Caring Sciences, Linköping University, 581 83 Linköping, Sweden.'}, {'ForeName': 'Ingela', 'Initials': 'I', 'LastName': 'Thylén', 'Affiliation': 'Department of Health Medicine and Caring Sciences, Linköping University, 581 83 Linköping, Sweden.'}, {'ForeName': 'Lotti', 'Initials': 'L', 'LastName': 'Orwelius', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Linköping University, 581 85 Linköping, Sweden.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Klompstra', 'Affiliation': 'Department of Health Medicine and Caring Sciences, Linköping University, 581 83 Linköping, Sweden.'}, {'ForeName': 'Tiny', 'Initials': 'T', 'LastName': 'Jaarsma', 'Affiliation': 'Department of Health Medicine and Caring Sciences, Linköping University, 581 83 Linköping, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph182111343']
3120,34769855,The Effects of Integrated Step Training into the Physical Education Curriculum of Children with Intellectual Disabilities.,"(1) Background: This study investigated the changes in step frequency, walking ability, and standing posture of students with intellectual disabilities by integrating step training into the students' physical education curriculum; (2) Methods: The centroid formula was used to estimate the geometric center of the students' bodies in video footage of each participant. Each participant's stepping frequency per minute was recorded. After training, the teachers involved were interviewed regarding the participants' everyday activities in school. Each step training session was recorded by two video cameras. Each step training session was observed and photographed by a senior physical education teacher with special education qualifications; (3) Results: The step training increased the stability of the participants' body axes. The participants' average steps per minute of the participants significantly improved from 24.200 ± 7.554 to 28.700 ± 8.629. Additionally, despite the students exhibiting anxious behavior (e.g., squeezing their hands and grasping at their clothes) at baseline, the frequency of these behaviors decreased significantly from week 4. Overall, the students' daily activities, motivation, interpersonal interaction, self-confidence, and anxiety behaviors improved; (4) Conclusions: After the 8-week step program, the participants with intellectual disabilities improved their step frequency, movement stability, ability to perform daily activities, walking speed, motivation, interpersonal interaction, and self-confidence, and they exhibited a lower level of anxiety-related behaviors.",2021,The participants' average steps per minute of the participants significantly improved from 24.200 ± 7.554 to 28.700 ± 8.629.,"['Children with Intellectual Disabilities', 'students with intellectual disabilities by']","[""integrating step training into the students' physical education curriculum"", 'Integrated Step Training']","[""students' daily activities, motivation, interpersonal interaction, self-confidence, and anxiety behaviors"", 'step frequency, movement stability, ability to perform daily activities, walking speed, motivation, interpersonal interaction, and self-confidence, and they exhibited a lower level of anxiety-related behaviors', ""stability of the participants' body axes""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]",4.0,0.0183035,The participants' average steps per minute of the participants significantly improved from 24.200 ± 7.554 to 28.700 ± 8.629.,"[{'ForeName': 'Pei-Fung', 'Initials': 'PF', 'LastName': 'Wu', 'Affiliation': 'Department of Kinesiology, Health and Leisure Studies, National University of Kaohsiung, Kaohsiung 811726, Taiwan.'}, {'ForeName': 'Yu-Wei', 'Initials': 'YW', 'LastName': 'Chang', 'Affiliation': 'Department of Kinesiology, Health and Leisure Studies, National University of Kaohsiung, Kaohsiung 811726, Taiwan.'}, {'ForeName': 'Tai-Been', 'Initials': 'TB', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging and Radiological Science, I-Shou University, Kaohsiung 824005, Taiwan.'}, {'ForeName': 'Li-Ching', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'School of Medicine for International Students, I-Shou University, Kaohsiung 824005, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph182111340']
3121,34769851,Effect of Eight-Month Exercise Intervention on Bone Outcomes of Young Opioid-Dependent Women.,"OBJECTIVE


To evaluate the bone response to an 8 month aerobic gymnastics training program in young opioid-addicted women.
DESIGN


Randomized controlled trial (parallel design).
SETTING


Women's Specific Drug Rehabilitation Center in China.
PATIENTS


One hundred and two young women with low bone quality and previous opioid addiction were divided into two groups: (a) the low bone quality intervention experimental group (n = 55; age: 30.3 ± 6.1) and (b) the low bone quality observed control group (observation group; n = 47; age: 29.0 ± 5.3).
INTERVENTIONS


The intervention group took aerobic gymnastics regularly for 80 min/d and 5 d/wk for 8 months and completed follow-up testing.
MAIN OUTCOME MEASURES


Substance use history and other life habits affecting bone quality were assessed by questionnaire-based interviews. Bone quality (stiffness-index, T-score, Z-score) was examined with quantitative ultrasound. Anthropometric characteristics (body weight, fat-free mass, fat mass) were obtained by bioelectrical impedance analysis.
RESULTS


After the 8 month intervention, the stiffness index of bone quality increased significantly (before: 82 ± 6, after: 108 ± 14,  p  < 0.05) in the experimental group. However, the bone quality did not change significantly in the controls (before: 79 ± 10, after: 77 ± 13,  p  > 0.05). The bone change in the difference group was significant (experimental group: 31.7% vs observation group: -0.03%). Fat mass decreased in the experimental group (experimental group: before: 19.6 ± 3.7 kg, after: 18.8 ± 4.0 kg,  p  < 0.05). Meanwhile, the change in fat-free mass was the determination of the change in bone quality in the experimental group.
CONCLUSIONS


Our results suggested that aerobic gymnastics intervention can be an effective strategy for the prevention and treatment of drug-induced osteoporosis in detoxification addicts.",2021,The bone change in the difference group was significant (experimental group: 31.7% vs observation group: -0.03%).,"['young opioid-addicted women', 'One hundred and two young women with low bone quality and previous opioid addiction', ""Women's Specific Drug Rehabilitation Center in China"", 'Young Opioid-Dependent Women']","['Eight-Month Exercise Intervention', 'low bone quality intervention experimental group', 'aerobic gymnastics intervention', 'aerobic gymnastics training program']","['bone change', 'Bone quality (stiffness-index, T-score, Z-score', 'Substance use history and other life habits affecting bone quality', 'bone response', 'Anthropometric characteristics (body weight, fat-free mass, fat mass', 'Bone Outcomes', 'Fat mass', 'bone quality', 'stiffness index of bone quality']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0524662', 'cui_str': 'Opioid dependence'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1510463', 'cui_str': 'Drug Rehabilitation Centers'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",102.0,0.0141565,The bone change in the difference group was significant (experimental group: 31.7% vs observation group: -0.03%).,"[{'ForeName': 'Zenghui', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Center for Information Technology of Sports and Health, Institute of Intelligent Machines, Hefei Institutes of Physical Science, Chinese Academy of Sciences , Hefei 230031, China.'}, {'ForeName': 'Zuchang', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Center for Information Technology of Sports and Health, Institute of Intelligent Machines, Hefei Institutes of Physical Science, Chinese Academy of Sciences , Hefei 230031, China.'}, {'ForeName': 'Xianjun', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Center for Information Technology of Sports and Health, Institute of Intelligent Machines, Hefei Institutes of Physical Science, Chinese Academy of Sciences , Hefei 230031, China.'}, {'ForeName': 'Yining', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Center for Information Technology of Sports and Health, Institute of Intelligent Machines, Hefei Institutes of Physical Science, Chinese Academy of Sciences , Hefei 230031, China.'}]",International journal of environmental research and public health,['10.3390/ijerph182111336']
3122,34769849,Effect of an Unsupervised Exercises-Based Athletics Injury Prevention Programme on Injury Complaints Leading to Participation Restriction in Athletics: A Cluster-Randomised Controlled Trial.,"OBJECTIVE


To test the efficacy of the Athletics Injury Prevention Programme (AIPP) to reduce the percentage of athletes presenting at least one injury complaint leading to participation restriction (ICPR) over an athletics season.
METHODS


During the 2017-2018 athletics season, we included in this cluster randomised controlled trial (ClinicalTrials.gov Identifier: NCT03307434) 840 athletes randomly assigned (randomisation unit: athletic clubs) to a control group (regular training) or to an intervention group (regular training plus the AIPP 2/week). Using a weekly online questionnaire, athletes reported the ICPR, training and competition exposures, and, for the intervention group, the compliance with the AIPP. The primary outcome was the percentage of athletes presenting at least one ICPR over the study follow-up.
RESULTS


A total of 449 and 391 athletes were included in the intervention and control groups, respectively. From them, 68 (15.1%) and 100 (25.6%) athletes, respectively, provided 100% of the requested information during the follow-up (39 weeks). A total of 6 (8.8%) performed the AIPP 2/week or more. The proportion of athletes who had at least one ICPR over the follow-up period was similar in the intervention (64.7%) and control groups (65.0%), with adjusted odds ratios: 0.81 (95% CI 0.36 to 1.85). There were no between-group differences when comparing separately the subgroups corresponding with the different compliance levels.
CONCLUSION


This cluster randomised controlled trial reported no efficacy of the AIPP. However, the overall response proportion and the compliance with the AIPP in the intervention group were low. In individual sports especially, efforts should be first made to improve the implementation and adoption of interventions.",2021,"There were no between-group differences when comparing separately the subgroups corresponding with the different compliance levels.
","['athletes presenting at least one injury complaint leading to participation restriction (ICPR) over an athletics season', 'During the 2017-2018 athletics season', 'A total of 449 and 391 athletes', 'Injury Complaints Leading to Participation Restriction in Athletics']","['control group (regular training) or to an intervention group (regular training plus the AIPP 2/week', 'Unsupervised Exercises-Based Athletics Injury Prevention Programme', 'Athletics Injury Prevention Programme (AIPP', 'AIPP']","['ICPR', 'percentage of athletes presenting at least one ICPR']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004161', 'cui_str': 'Sports injury'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",840.0,0.0884589,"There were no between-group differences when comparing separately the subgroups corresponding with the different compliance levels.
","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Edouard', 'Affiliation': 'Inter-University Laboratory of Human Movement Science (LIBM EA 7424), University Jean Monnet, University of Lyon, F-42023 Saint Etienne, France.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Steffen', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, 0806 Oslo, Norway.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Peuriere', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation (DRCI), Centre Hospitalo-Universitaire (CHU) de Saint-Etienne, 42055 Saint-Etienne, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gardet', 'Affiliation': ""PGC, 42580 L'Etrat, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Navarro', 'Affiliation': 'Mines Saint-Etienne, U1059 Sainbiose, INSERM, University Jean Monnet, University of Lyon, F-42023 Saint-Etienne, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blanco', 'Affiliation': 'Physiotherapy Department, Universitat Internacional de Catalunya, Sant Cugat del Vallès, 08195 Barcelona, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph182111334']
3123,34772433,"The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial.","BACKGROUND


Primary prevention trials have demonstrated that the traditional Mediterranean diet is associated with a reduction in cardiovascular mortality and morbidity. However, this benefit has not been proven for secondary prevention after an acute coronary syndrome (ACS). We hypothesized that a high-intensity Mediterranean diet intervention after an ACS decreases the vulnerability of atherosclerotic plaques by complex interactions between anti-inflammatory effects, microbiota changes and modulation of gene expression.
METHODS


The MEDIMACS project is an academically funded, prospective, randomized, controlled and mechanistic clinical trial designed to address the effects of an active randomized intervention with the Mediterranean diet on atherosclerotic plaque vulnerability, coronary endothelial dysfunction and other mechanistic endpoints. One hundred patients with ACS are randomized 1:1 to a monitored high-intensity Mediterranean diet intervention or to a standard-of-care arm. Adherence to diet is assessed in both arms using food frequency questionnaires and biomarkers of compliance. The primary endpoint is the change (from baseline to 12 months) in the thickness of the fibrous cap of a non-significant atherosclerotic plaque in a non-culprit vessel, as assessed by repeated optical coherence tomography intracoronary imaging. Indices of coronary vascular physiology and changes in gastrointestinal microbiota, immunological status and protein and metabolite profiles will be evaluated as secondary endpoints.
DISCUSSION


The results of this trial will address the key effects of dietary habits on atherosclerotic risk and will provide initial data on the complex interplay of immunological, microbiome-, proteome- and metabolome-related mechanisms by which non-pharmacological factors may impact the progression of coronary atherosclerosis after an ACS.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03842319 . Registered on 13 May 2019.",2021,"The primary endpoint is the change (from baseline to 12 months) in the thickness of the fibrous cap of a non-significant atherosclerotic plaque in a non-culprit vessel, as assessed by repeated optical coherence tomography intracoronary imaging.","['acute coronary syndrome', 'One hundred patients with ACS']","['Mediterranean diet', 'monitored high-intensity Mediterranean diet intervention or to a standard-of-care arm']","['cardiovascular mortality and morbidity', 'coronary plaque vulnerability, microvascular function, inflammation and microbiome', 'thickness of the fibrous cap of a non-significant atherosclerotic plaque in a non-culprit vessel', 'coronary vascular physiology and changes in gastrointestinal microbiota, immunological status and protein and metabolite profiles', 'vulnerability of atherosclerotic plaques', 'atherosclerotic plaque vulnerability, coronary endothelial dysfunction']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbiota'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]",100.0,0.0522259,"The primary endpoint is the change (from baseline to 12 months) in the thickness of the fibrous cap of a non-significant atherosclerotic plaque in a non-culprit vessel, as assessed by repeated optical coherence tomography intracoronary imaging.","[{'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Fernández', 'Affiliation': 'Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bermejo', 'Affiliation': 'Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain. javier.bermejo@salud.madrid.org.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Yotti', 'Affiliation': 'Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-Gonzalez', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, IDISNA, CIBEROBN, Pamplona, Spain.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mira', 'Affiliation': 'Department of Health and Genomics, Center for Advanced Research in Public Health, CSISP-FISABIO, and CIBERESP, Valencia, Spain.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Gophna', 'Affiliation': 'Department of Molecular Microbiology and Biotechnology, George S. Wise Faculty of Life Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv, Israel.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Karlsson', 'Affiliation': 'Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy of the University of Gothenburg; Sweden Nanoxis Consulting AB; Centre for Antibiotic Resistance Research (CARe), University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Al-Daccak', 'Affiliation': 'Institut National de la Santé et de la Recherche Médicale (INSERM) UMRS-97f, Université Paris-Diderot, HLA et Médecine, Labex Transplantex, Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Martín-Demiguel', 'Affiliation': 'Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gutiérrez-Ibanes', 'Affiliation': 'Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Charron', 'Affiliation': 'Institut National de la Santé et de la Recherche Médicale (INSERM) UMRS-97f, Université Paris-Diderot, HLA et Médecine, Labex Transplantex, Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Fernández-Avilés', 'Affiliation': 'Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-021-05746-z']
3124,34772434,Improving phenylalanine and micronutrients status of children with phenylketonuria: a pilot randomized study.,"BACKGROUND


Children with Phenylketonuria (PKU) need a special diet to avoid a variety of physical and psychological complications. The aim of this study was to compare and assess the effects of two interventions on and levels of phenylalanine and micronutrients in children with PKU.
METHODS


Forty-six children with PKU (ages 1-12 years) and their caregivers were randomly assigned to one of two 10-week interventions: a caregiver educational intervention based on the Integrative Model of Behvioral Prediction (IMBP) and supplementary low-protein-modified foods. Outcomes consisted of Children's plasma phenylalanine and micronutrients (i.e., vitamin B12, vitamin D3, and zinc) and hemoglobin levels. To assess the sustainability of outcomes, we also compared the children's phenylalanine level at five-time points including baseline and 10-week, 6 months, 12 months, and 24 months follow-ups. In addition, caregivers of both groups were asked to complete a questionnaire to assess how well the interventions were implemented as well as satisfaction with interventions.
RESULTS


While a large percentage of children had phenylalanine levels out of range indicating non-adherence (69.6% and 81% in the educational and food items group, respectively), micronutrient deficiencies were not prevalent in the patient cohort. The levels of phenylalanine in both groups decreased significantly over time. However, conducting a repeated-measures ANOVA to evaluating the change in groups across five-time points, revealed a significant difference between groups (F = 4.68, p = 0.03). That is, the educational intervention was more effective in lowering the children's phenylalanine level. At 24-month follow-up, the percentage of children with a normal range of phenylalanine level in the educational and food items groups increased to 73.9 and 57.1 percent, respectively, from 26 and 38 percent at baseline. There were no significant changes in children's micronutrients level following the interventions, except in the hemoglobin. In this way, at 10-week follow-up, the mean hemoglobin of children in the educational group reduced significantly (P = 0.041). However, there was no significant difference between the two groups. In general, all caregivers completed the process evaluation checklist, the feedback was largely positive.
CONCLUSIONS


The results of this study demonstrated that both educational and providing food item interventions resulted in a significant reduction in phenylalanine levels. Empowering caregivers of patients, creating and fortifying social networks, providing favorable social supports, and providing access to special food items may be effective in controlling PKU.
CLINICAL TRIAL REGISTRATION


Iranian Registry of Clinical Trials (IRCT20180506039548N1). Registered 6th Jun 2018, https://www.irct.ir/trial/30977 .",2021,The results of this study demonstrated that both educational and providing food item interventions resulted in a significant reduction in phenylalanine levels.,"['children with PKU', 'Children with Phenylketonuria (PKU', 'Forty-six children with PKU (ages 1-12\xa0years) and their caregivers', 'children with phenylketonuria']","['phenylalanine', 'caregiver educational intervention based on the Integrative Model of Behvioral Prediction (IMBP) and supplementary low-protein-modified foods']","[""Children's plasma phenylalanine and micronutrients (i.e., vitamin B12, vitamin D3, and zinc) and hemoglobin levels"", 'mean hemoglobin of children', ""children's micronutrients level"", 'phenylalanine levels', 'levels of phenylalanine', 'percentage of children with a normal range of phenylalanine level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428204', 'cui_str': 'Phenylalanine level - finding'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}]",46.0,0.0527166,The results of this study demonstrated that both educational and providing food item interventions resulted in a significant reduction in phenylalanine levels.,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zamani', 'Affiliation': 'Department of Public Health, School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave., Hamadan, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Karimi-Shahanjarini', 'Affiliation': 'Department of Public Health, School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave., Hamadan, Iran. karimi.a@umsha.ac.ir.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Tapak', 'Affiliation': 'Department of Biostatistics, School of Public Health, Modeling of Noncommunicable Diseases Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Moeini', 'Affiliation': 'Department of Public Health, School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave., Hamadan, Iran.'}]",Orphanet journal of rare diseases,['10.1186/s13023-021-02094-8']
3125,34772432,Auditory-cognitive training for adult cochlear implant recipients: a study protocol for a randomised controlled trial.,"BACKGROUND


There is an urgent need to develop new therapies to improve cognitive function in adults following cochlear implant surgery. This study aims to determine if completing at-home computer-based brain training activities improve memory and thinking skills in adults following their first cochlear implant.
METHODS


This study will be conducted as a single-blind, head-to-head, randomised controlled trial (RCT). It will determine whether auditory training combined with adaptive computerised cognitive training will elicit greater improvement in cognition, sound and speech perception, mood, and quality of life outcomes in adult cochlear implant recipients, when compared to auditory training combined with non-adaptive (i.e. placebo) computerised cognitive training. Participants 18 years or older who meet the clinical criteria for a cochlear implant will be recruited into the study.
RESULTS


The results of this trial will clarify whether the auditory training combined with cognitive training will improve cognition, sound and speech perception, mood, and quality of life outcomes in adult cochlear implant recipients.
DISCUSSION


We anticipate that our findings will have implications for clinical practice in the treatment of adult cochlear implant recipients.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12619000609156 . Registered on April 23 2019.",2021,"It will determine whether auditory training combined with adaptive computerised cognitive training will elicit greater improvement in cognition, sound and speech perception, mood, and quality of life outcomes in adult cochlear implant recipients, when compared to auditory training combined with non-adaptive (i.e. placebo) computerised cognitive training.","['Participants 18\u2009years or older who meet the clinical criteria for a cochlear implant will be recruited into the study', 'adults following their first cochlear implant', 'adults following cochlear implant surgery', 'adult cochlear implant recipients']","['auditory training combined with cognitive training', 'Auditory-cognitive training', 'auditory training combined with non-adaptive (i.e. placebo) computerised cognitive training', 'auditory training combined with adaptive computerised cognitive training', 'home computer-based brain training activities']","['cognition, sound and speech perception, mood, and quality of life outcomes', 'memory and thinking skills', 'cognitive function']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040606', 'cui_str': 'Training Activities'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C4279942', 'cui_str': 'Thinking Skills'}]",,0.16595,"It will determine whether auditory training combined with adaptive computerised cognitive training will elicit greater improvement in cognition, sound and speech perception, mood, and quality of life outcomes in adult cochlear implant recipients, when compared to auditory training combined with non-adaptive (i.e. placebo) computerised cognitive training.","[{'ForeName': 'Blake J', 'Initials': 'BJ', 'LastName': 'Lawrence', 'Affiliation': 'School of Population Health, Curtin University, Bentley, WA, Australia.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Eikelboom', 'Affiliation': 'Ear Science Institute Australia, 1 Salvado Road, Subiaco, WA, 6008, Australia.'}, {'ForeName': 'Dona M P', 'Initials': 'DMP', 'LastName': 'Jayakody', 'Affiliation': 'Ear Science Institute Australia, 1 Salvado Road, Subiaco, WA, 6008, Australia. dona.jayakody@uwa.edu.au.'}]",Trials,['10.1186/s13063-021-05714-7']
3126,34772904,The Motor Engram of Functional Connectivity Generated by Acute Whole-Body Dynamic Balance Training.,"PURPOSE


Whole-body dynamic balance is necessary for both athletic activities and activities of daily living. This study aimed to investigate the effect of acute dynamic balance training on neural networks.
METHODS


We evaluated resting-state functional connectivity (rs-FC), white matter fiber density (FD), fiber-bundle cross-section (FC), and gray matter volume in 28 healthy young adults (14 women) before and after 30 minutes of slackline training using a randomized, counterbalanced crossover design.
RESULTS


The rs-FC between the left lateral prefrontal cortex (PFC) and foot area of the primary sensorimotor cortex (SM1) increased significantly after slackline training compared to that after a control condition involving ergometer-based aerobic exercise. In addition, changes in rs-FC between the left lateral PFC and SM1 were correlated with performance changes after training (i.e., offline process) rather than online learning. We also observed a main effect of time between the hippocampus and cingulate cortex, including the anterior areas, and between the bilateral lateral PFCs. Although we observed no structural changes, FD in the commissural fiber pathway before the first balance assessment was correlated with initial balance capability.
CONCLUSIONS


Our findings demonstrate that acute whole-body dynamic balance training alters specific rs-FC, and that this change is associated with performance changes after training. In addition, rs-FC changes in cognitive regions were modulated by both acute dynamic balance training and aerobic exercise. These findings have the potential to influence various fields (e.g., sports neuroscience, neurorehabilitation) and may aid in the development of methods that can improve motor and cognitive performance.",2021,(SM1) increased significantly after slackline training compared to that after a control condition involving ergometer-based aerobic exercise.,['28 healthy young adults (14 women) before and after 30 minutes of'],"['acute dynamic balance training', 'slackline training']","['resting-state functional connectivity (rs-FC), white matter fiber density (FD), fiber-bundle cross-section (FC), and gray matter volume']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",28.0,0.00803058,(SM1) increased significantly after slackline training compared to that after a control condition involving ergometer-based aerobic exercise.,"[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ueta', 'Affiliation': 'College of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan Research Organization of Science and Technology, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Mizuguchi', 'Affiliation': ''}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sugiyama', 'Affiliation': ''}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Isaka', 'Affiliation': ''}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Otomo', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002829']
3127,34772775,Differences in Occupational Burnout Among Primary Care Professionals.,"BACKGROUND


Occupational burnout is a major concern for personal well-being and patient care. We examined burnout among primary care providers (PCPs), medical residents, behavioral health providers (BHPs), nurses, and other clinical and nonclinical primary care team members.
METHODS


This was a cross-sectional study, nested within a larger randomized trial. Participants completed a validated 9-item burnout measure with 3 domains: depersonalization, emotional exhaustion, and personal accomplishment. Multivariable multilevel linear regression with a random intercept for each practice was used to determine mean differences in burnout across professional roles.
RESULTS


Overall burnout rates varied by professional role: PCPs 70%, medical residents 89%, BHPs 59%, nurses 66%, other clinicians 68%, and nonclinical professionals 70%. Compared with nonclinical professionals, residents experienced more burnout in more domains, followed by PCPs. PCPs, residents, and nurses reported significantly worse depersonalization and exhaustion scores. Nonclinical professionals had worse accomplishment scores than all clinical professionals except for residents. This study revealed moderate-to-high levels of burnout among primary care professionals.
DISCUSSION


Clinicians may be experiencing aspects of burnout more intensely than their nonclinical colleagues, and this may be most true for residents and PCPs. Based on these variations, interventions to mitigate burnout may need to be tailored by professional role.",2021,"PCPs, residents, and nurses reported significantly worse depersonalization and exhaustion scores.","['primary care providers (PCPs), medical residents, behavioral health providers (BHPs), nurses, and other clinical and nonclinical primary care team members']",[],"['accomplishment scores', 'validated 9-item burnout measure with 3 domains: depersonalization, emotional exhaustion, and personal accomplishment', 'depersonalization and exhaustion scores']","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]",,0.0832525,"PCPs, residents, and nurses reported significantly worse depersonalization and exhaustion scores.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Clifton', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL). jessica.clifton@med.uvm.edu.'}, {'ForeName': 'Levi', 'Initials': 'L', 'LastName': 'Bonnell', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL).'}, {'ForeName': 'Juvena', 'Initials': 'J', 'LastName': 'Hitt', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL).'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Crocker', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL).'}, {'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Rose', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL).'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'van Eeghen', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL).'}, {'ForeName': 'Rodger', 'Initials': 'R', 'LastName': 'Kessler', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL).'}, {'ForeName': 'Kari A', 'Initials': 'KA', 'LastName': 'Stephens', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL).'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Teng', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL).'}, {'ForeName': 'Janeen', 'Initials': 'J', 'LastName': 'Leon', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL).'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Mollis', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL).'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Littenberg', 'Affiliation': 'From University of Vermont, Burlington (JC, LB, JH, AC, GLR, CvE, BL); University of Colorado, Aurora (RK); University of Washington, Seattle (KAS, BM); MetroHealth System, Case Western Reserve University, Cleveland (KT, JL).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2021.06.210139']
3128,34772753,Radiotherapy for head and neck tumours using an oral fixation and parameter acquisition device and TOMO technology: a randomised controlled study.,"INTRODUCTION


Radiotherapy has become one of the main methods used for the treatment of malignant tumours of the head and neck. Spiral tomographic intensity-modulated radiotherapy has the many advantages of precision radiotherapy, which puts forward high requirements for postural reproducibility and accuracy. We will aim to ensure that the accurate positioning of the tumour will reduce the side effects of radiotherapy caused by positioning errors. We will design and implement this clinical trial using the patent of 'a radiotherapy oral fixation and parameter acquisition device (patent number: ZL201921877986.5)'.
METHODS AND ANALYSIS


This will be a randomised, controlled, prospective study with 120 patients with head and neck tumours. Using the random number table method, a random number sequence will be generated, and the patients will be enrolled in the experimental group (oral fixation device) and the control group (conventional fixation) in a 2:1 ratio. The primary outcome will be the progression-free survival time after the treatment. Secondary outcomes will include the oral mucosal reaction and the quality of life. Follow-ups will be carried out according to the plan. This is V.1.0 of protocol on 1 April 2021. The recruitment process for this clinical trial commenced on 1 May 2021, and will end on 1 October 2022.
ETHICS AND DISSEMINATION


The trial received ethical approval from Medical Ethics Committee of Liaoning Provincial Cancer Hospital (number 20210131X). The final results will be presented at a scientific conference and published in a peer-reviewed journal in accordance with the journal's guidelines.
TRIAL REGISTRATION NUMBER


ChiCTR2100045096.",2021,"Spiral tomographic intensity-modulated radiotherapy has the many advantages of precision radiotherapy, which puts forward high requirements for postural reproducibility and accuracy.","['120 patients with head and neck tumours', 'head and neck tumours']","['radiotherapy', 'Radiotherapy', 'oral fixation and parameter acquisition device and TOMO technology', 'Spiral tomographic intensity-modulated radiotherapy']","['oral mucosal reaction and the quality of life', 'progression-free survival time']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0522554', 'cui_str': 'Spiral shape'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0026639', 'cui_str': 'Oral mucous membrane structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",120.0,0.0802309,"Spiral tomographic intensity-modulated radiotherapy has the many advantages of precision radiotherapy, which puts forward high requirements for postural reproducibility and accuracy.","[{'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiotherapy, Cancer Hospital of China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Tianlu', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Radiotherapy, Cancer Hospital of China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Xinyan', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'China Medical University, Cancer Hospital of China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Radiotherapy, Cancer Hospital of China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Chen Yu', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Information Management, Cancer Hospital of China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Department of Pathology, Cancer Hospital of China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Radiotherapy Physics, Cancer Hospital of China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Yingqiu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Radiotherapy, Cancer Hospital of China Medical University, Shenyang, Liaoning, China syq18900917411@163.com.'}]",BMJ open,['10.1136/bmjopen-2021-052542']
3129,34772749,"Acupuncture for retinitis pigmentosa: study protocol for a randomised, sham-controlled trial.","INTRODUCTION


Primary retinitis pigmentosa (RP) is a common hereditary retinal disease in ophthalmology that has a considerable impact on quality of life, but there are few effective therapeutic strategies. This trial aims to determine the efficacy and safety of acupuncture versus sham acupuncture (SA) for RP.
METHODS AND ANALYSIS


This is a study protocol for a randomised, participant-blind, sham-controlled trial. 64 eligible patients with RP will randomly be divided into acupuncture group and SA group. All groups will receive 48 sessions over 3 months. Participants will complete the trial by visiting the research centre in month 6/9 for a follow-up assessment. The primary outcome is visual field mean sensitivity and visual field mean deviation at month 3/6/9 compared with baseline. Secondary outcomes include the best-corrected visual acuity, central macular thickness, subfoveal choroidal thicknes, traditional Chinese medicine syndrome score and the scale of life quality for diseases with visual impairment at month 3/6/9 compared with baseline. Adverse events and safety indexes will be recorded throughout the study. SPSS V.25.0 statistical software was used for analysis, and measurement data were expressed as mean±SD.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethics Committee of the Chinese Clinical Trial Registry (approval no: ChiECRCT20200460). The results of this study will be published in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.
TRIAL REGISTRATION NUMBER


ChiCTR2000041090.",2021,The primary outcome is visual field mean sensitivity and visual field mean deviation at month 3/6/9 compared with baseline.,"['64 eligible patients with RP', 'retinitis pigmentosa']","['acupuncture', 'acupuncture versus sham acupuncture (SA', 'Acupuncture']","['Adverse events and safety indexes', 'visual field mean sensitivity and visual field mean deviation', 'efficacy and safety', 'best-corrected visual acuity, central macular thickness, subfoveal choroidal thicknes, traditional Chinese medicine syndrome score and the scale of life quality for diseases with visual impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035334', 'cui_str': 'Retinitis pigmentosa'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1828170', 'cui_str': 'Mean deviation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}]",64.0,0.707128,The primary outcome is visual field mean sensitivity and visual field mean deviation at month 3/6/9 compared with baseline.,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Ruxue', 'Initials': 'R', 'LastName': 'Lei', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Weiwen', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Gao', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Yanlin', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China zhengyanlin@cdutcm.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2021-049245']
3130,34772747,Protocol for 'Resilient Caregivers': a randomised trial of a resilience-based intervention for psychologically distressed partner caregivers of patients with cancer.,"INTRODUCTION


Intimate partners of patients with cancer often experience significant distress, but there is a lack of psychological interventions that specifically target this population. 'Resilient Caregivers' is a novel resilience-based intervention for distressed partner cancer caregivers. The intervention was developed according to a resilience framework focusing on meta-reflective skills, coping strategies and value clarification. The aim of this study is to evaluate the effectiveness of this intervention in a randomised trial.
METHODS AND ANALYSIS


Eighty participants will be invited through the Oncology Department at Herlev Hospital, Denmark and randomised to either the intervention or usual care. Participants are eligible if they are partners (married or unmarried) of patients diagnosed with cancer and experience distress (>4 on the distress thermometer). 'Resilient Caregivers' consists of seven manualised group sessions (2.5 hours each), focusing on resilience in relation to being a partner caregiver of a patient with cancer. The primary outcome is symptoms of anxiety, while secondary outcomes include distress, depression, quality of life, sleep quality and resilience. Data will be collected at baseline, 3, 6 and 12 months follow-up using validated scales, and analysed using mixed models for repeated measures.
ETHICS AND DISSEMINATION


This study will follow the ethical principles in the Declaration of Helsinki and has been reviewed by the Ethics Committee of the Capital Region of Denmark (Journal no. 18055373). Written informed consent will be obtained from all participants. Results will be reported through scientific peer-reviewed journals and relevant conferences.
TRIAL REGISTRATION NUMBER


NCT04610034.",2021,"Resilient Caregivers' consists of seven manualised group sessions (2.5 hours each), focusing on resilience in relation to being a partner caregiver of a patient with cancer.","['distressed partner cancer caregivers', 'Participants are eligible if they are partners (married or unmarried) of patients diagnosed with cancer and experience distress (>4 on the distress thermometer). ', 'Eighty participants will be invited through the Oncology Department at Herlev Hospital, Denmark and randomised to either the intervention or usual care', 'Resilient Caregivers', 'psychologically distressed partner caregivers of patients with cancer']",['resilience-based intervention'],"['distress, depression, quality of life, sleep quality and resilience', 'symptoms of anxiety']","[{'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",80.0,0.212849,"Resilient Caregivers' consists of seven manualised group sessions (2.5 hours each), focusing on resilience in relation to being a partner caregiver of a patient with cancer.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Genter', 'Affiliation': 'Herlev Cancer Counseling Center, Danish Cancer Society, Copenhagen, Denmark.'}, {'ForeName': 'Beverley Lim', 'Initials': 'BL', 'LastName': 'Høeg', 'Affiliation': 'Psychological Aspects of Cancer Research Group, Danish Cancer Society Research Center, Copenhagen, Denmark bevlim@cancer.dk.'}, {'ForeName': 'Camilla Jensen', 'Initials': 'CJ', 'LastName': 'Hamre', 'Affiliation': 'Herlev Cancer Counseling Center, Danish Cancer Society, Copenhagen, Denmark.'}, {'ForeName': 'Elisabeth Anne Wreford', 'Initials': 'EAW', 'LastName': 'Andersen', 'Affiliation': 'Statistics and Data Analysis, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Susanne Oksbjerg', 'Initials': 'SO', 'LastName': 'Dalton', 'Affiliation': 'Survivorship and Inequality in Cancer Research Group, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Ribers', 'Affiliation': 'Department for the Study of Culture, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Pernille Envold', 'Initials': 'PE', 'LastName': 'Bidstrup', 'Affiliation': 'Psychological Aspects of Cancer Research Group, Danish Cancer Society Research Center, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-048327']
3131,34769878,Parental Book-Reading to Preterm Born Infants in NICU: The Effects on Language Development in the First Two Years.,"BACKGROUND


After preterm birth, infants are at high risk for delays in language development. A promising intervention to reduce this risk is represented by the exposure to parental voices through book-reading in Neonatal Intensive Care Units (NICU). This study investigated the possible advantages of book-reading to preterm neonates during their NICU stay on their subsequent language development.
METHODS


100 families of preterm infants were recruited. The parents of 55 preterm infants (Reading Group) received a colored picture-book on NICU admission and were supported to read to their neonate as often as possible and to continue after hospital discharge. Forty-five infants (Control Group) were recruited before the beginning of the intervention. Infant language development was assessed with the Hearing and Language quotients of the Griffith Mental Development Scale at the corrected ages of 3, 6, 9, 12, 18 and 24 months.
RESULTS


Regardless of group membership, Hearing and Language mean quotients decreased between 9 and 18 months; nevertheless, this decrease was considerably reduced in the Reading group, compared to the Control Group.
CONCLUSIONS


Reading in NICUs represents a suitable intervention that could positively influence language development and parent-infant relationships in preterm children. The study findings support its implementation as a preventive measure.",2021,"Regardless of group membership, Hearing and Language mean quotients decreased between 9 and 18 months; nevertheless, this decrease was considerably reduced in the Reading group, compared to the Control Group.
","['preterm children', 'Preterm Born Infants in NICU', 'preterm neonates during their NICU stay on their subsequent language development', 'Forty-five infants (Control Group', '55 preterm infants (Reading Group', '100 families of preterm infants were recruited']",['colored picture-book on NICU admission'],"['Language Development', 'Hearing and Language quotients of the Griffith Mental Development Scale', 'Hearing and Language mean quotients']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",55.0,0.109665,"Regardless of group membership, Hearing and Language mean quotients decreased between 9 and 18 months; nevertheless, this decrease was considerably reduced in the Reading group, compared to the Control Group.
","[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Neri', 'Affiliation': 'Department of Psychology ""Renzo Canestrari"", University of Bologna, 40127 Bologna, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'De Pascalis', 'Affiliation': 'Department of Psychology ""Renzo Canestrari"", University of Bologna, 40127 Bologna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Agostini', 'Affiliation': 'Department of Psychology ""Renzo Canestrari"", University of Bologna, 40127 Bologna, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Genova', 'Affiliation': 'Department of Psychology ""Renzo Canestrari"", University of Bologna, 40127 Bologna, Italy.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Biasini', 'Affiliation': 'Donor Human Milk Bank Italian Association (AIBLUD), 20126 Milan, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Stella', 'Affiliation': 'Pediatric and Neonatal Intensive Care Unit, Maurizio Bufalini Hospital, 47521 Cesena, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Trombini', 'Affiliation': 'Department of Psychology ""Renzo Canestrari"", University of Bologna, 40127 Bologna, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph182111361']
3132,34769876,The Effect of a Structured Individualized Educational Intervention on Breastfeeding Rates in Greek Women.,"Breastfeeding rates remain extremely low in Greece and women with gestational diabetes mellitus and hypothyroidism may experience additional difficulties. The aim of the study was to investigate the effect of a structured individualized lactation educational intervention by a midwife on increasing breastfeeding rates in women with endocrine disorders and low-risk women compared to women receiving standard care, 24 months after delivery. Two-hundred women made up the study population. Half of them were experiencing endocrine pregnancy disorders and 100 women constituted the low-risk pregnancy standard care control group. Women who were breastfeeding exclusively were significantly higher in the midwifery intervention group with endocrine disorders, namely breastfeeding continued at four months (breastfeeding: 20% vs. 12%, exclusive breastfeeding: 50% vs. 26%,  p  = 0.0228), and at six months after childbirth (breastfeeding: 54% vs. 28%, exclusive breastfeeding: 32% vs. 12%,  p  = 0.0011), compared to the standard care control group with endocrine disorder. The low-risk midwifery intervention group breastfed at four months (22% vs. 14%,  p  = 0.0428) and at six months (52% vs. 26%,  p  = 0.0018) at higher rates compared to the standard care control group. In addition, exclusive breastfeeding was significantly higher in the low-risk midwifery intervention group at four months (46% vs. 20%,  p  = 0.0102) and six months (38% vs. 4%,  p  < 0.0001) compared to the standard care control group. This study was the first attempt of a structured midwifery breastfeeding education in Greece and its major contribution reflects a significant positive impact on breastfeeding rates in terms of duration and exclusivity in women with gestational endocrine disorders as well as in low-risk women, and could possibly be applied and instituted in everyday clinical practice to increase the low breastfeeding rates in Greece.",2021,"p  = 0.0102) and six months (38% vs. 4%,  p  < 0.0001) compared to the standard care control group.","['Greek Women', 'Half of them were experiencing endocrine pregnancy disorders and 100 women constituted the low-risk pregnancy standard care control group', 'women with endocrine disorders and low-risk women compared to women receiving standard care, 24 months after delivery', 'women with gestational endocrine disorders', 'Two-hundred women made up the study population']","['Structured Individualized Educational Intervention', 'structured individualized lactation educational intervention']","['Breastfeeding Rates', 'breastfeeding rates']","[{'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0151864', 'cui_str': 'Disorder of pregnancy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0404841', 'cui_str': 'Low risk pregnancy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014130', 'cui_str': 'Disorder of endocrine system'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}]",200.0,0.0128543,"p  = 0.0102) and six months (38% vs. 4%,  p  < 0.0001) compared to the standard care control group.","[{'ForeName': 'Theoni', 'Initials': 'T', 'LastName': 'Truva', 'Affiliation': 'Department of Obstetrics & Gynaecology, University Hospital of Larisa, 41334 Larisa, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Valasoulis', 'Affiliation': 'Department of Obstetrics & Gynaecology, University Hospital of Larisa, 41334 Larisa, Greece.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Pouliakis', 'Affiliation': 'Second Department of Pathology, National and Kapodistrian University of Athens, Attikon University Hospital, 12464 Athens, Greece.'}, {'ForeName': 'Irontianta', 'Initials': 'I', 'LastName': 'Gkorezi-Ntavela', 'Affiliation': 'Department of Obstetrics & Gynaecology, University Hospital of Larisa, 41334 Larisa, Greece.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Pappa', 'Affiliation': 'Department of Endocrinology and Metabolic Diseases, Faculty of Medicine, School of Health Sciences, University of Thessaly, 41334 Larissa, Greece.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Bargiota', 'Affiliation': 'Department of Endocrinology and Metabolic Diseases, Faculty of Medicine, School of Health Sciences, University of Thessaly, 41334 Larissa, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Garas', 'Affiliation': 'Department of Obstetrics & Gynaecology, University Hospital of Larisa, 41334 Larisa, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Grivea', 'Affiliation': 'Department of Pediatrics, University of Thessaly, University Hospital of Larissa, 41334 Larissa, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Daponte', 'Affiliation': 'Department of Obstetrics & Gynaecology, University Hospital of Larisa, 41334 Larisa, Greece.'}]",International journal of environmental research and public health,['10.3390/ijerph182111359']
3133,34769874,Increasing Heart Rate Variability through Progressive Muscle Relaxation and Breathing: A 77-Day Pilot Study with Daily Ambulatory Assessment.,"The aim of this study was to examine whether it is possible to gradually increase heart rate variability (HRV) in healthy individuals (21 participants,  M  = 21.24 years,  SD  = 1.57, range 19 to 26) through regular exercises of average resonance frequency training (RFT; 6 breaths/min; 5 min each day) and progressive muscle relaxation (PMR; three times a week for 20 min). The effects were tested against an active control group using a linear mixed effect model with random slopes (day), random intercepts (participants) and an autoregressive error term. The special feature of this pilot study is that HRV was measured every day in an ambulatory assessment over 77 days, so that graduate long-term effects on HRV can be mapped. The results indicated that the PMR group significantly increased their HRV compared to the active control group. However, no effect was observed for the RFT group. Possible explanations for these results and important recommendations for subsequent studies are provided.",2021,The results indicated that the PMR group significantly increased their HRV compared to the active control group.,"['healthy individuals (21 participants,  M  = 21.24 years,  SD  = 1.57, range 19 to 26) through regular exercises of average resonance frequency training (RFT; 6 breaths/min; 5 min each day) and progressive muscle relaxation (PMR; three times a week for 20 min']","['PMR', 'Progressive Muscle Relaxation and Breathing']","['HRV', 'heart rate variability (HRV']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0231881', 'cui_str': 'Resonance'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0032533', 'cui_str': 'Polymyalgia rheumatica'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}]","[{'cui': 'C0032533', 'cui_str': 'Polymyalgia rheumatica'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0197148,The results indicated that the PMR group significantly increased their HRV compared to the active control group.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Groß', 'Affiliation': 'Department of Educational and Health Psychology, University of Education Schwäbisch Gmünd, Oberbettringerstraße 200, 73525 Schwäbisch Gmünd, Germany.'}, {'ForeName': 'Carl-Walter', 'Initials': 'CW', 'LastName': 'Kohlmann', 'Affiliation': 'Department of Educational and Health Psychology, University of Education Schwäbisch Gmünd, Oberbettringerstraße 200, 73525 Schwäbisch Gmünd, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph182111357']
3134,34769863,Effects of Oral Function Training and Oral Health Status on Physical Performance in Potentially Dependent Older Adults.,"This study aimed to evaluate the effects of an oral function training program and indicators of oral health status on improvements in physical performance induced by physical function training in dependent older adults. The participants were 131 potentially dependent older adults (age: ≥65 years) who were randomly divided into two groups: an oral intervention and a control group. All participants underwent physical function training, but only the intervention group took part in the oral function training program. In total, 106 participants completed all of the survey components (60 and 46 participants from the intervention and control groups, respectively). The measures of physical fitness examined included the one-leg standing time with eyes open (OLST) and the timed up and go test (TUG). Logistic regression analyses were carried out to determine the effects of the oral function intervention and health status on physical fitness. The results revealed that the oral function intervention significantly improved OLST and TUG times. These findings suggest that evaluations of oral health status and interventions aimed at activating oral functions are associated with improvements in physical fitness among potentially dependent older adults.",2021,These findings suggest that evaluations of oral health status and interventions aimed at activating oral functions are associated with improvements in physical fitness among potentially dependent older adults.,"['Potentially Dependent Older Adults', '106 participants completed all of the survey components (60 and 46 participants from the intervention and control groups, respectively', 'participants were 131 potentially dependent older adults (age: ≥65 years', 'dependent older adults']","['physical function training', 'oral function training program', 'physical function training, but only the intervention group took part in the oral function training program', 'Oral Function Training and Oral Health Status', 'oral intervention and a control group']","['physical fitness', 'Physical Performance', 'leg standing time with eyes open (OLST) and the timed up and go test (TUG', 'OLST and TUG times']","[{'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",131.0,0.00722576,These findings suggest that evaluations of oral health status and interventions aimed at activating oral functions are associated with improvements in physical fitness among potentially dependent older adults.,"[{'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sasajima', 'Affiliation': 'Health Promotion Division, Department of Health and Social Welfare, Niigata Prefectural Government, 4-1 Shinko-cho, Chuo-Ku, Niigata 950-8570, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Yoshihara', 'Affiliation': 'Division of Oral Science for Health Promotion, Faculty of Dentistry & Graduate School of Medical and Dental Science, Niigata University, 2-5274 Gakkocho-dori, Chuo-Ku, Niigata 951-8514, Japan.'}, {'ForeName': 'Ayuko', 'Initials': 'A', 'LastName': 'Odajima', 'Affiliation': 'Division of Oral Science for Health Promotion, Faculty of Dentistry & Graduate School of Medical and Dental Science, Niigata University, 2-5274 Gakkocho-dori, Chuo-Ku, Niigata 951-8514, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph182111348']
3135,34769831,The Effects of Running Compared with Functional High-Intensity Interval Training on Body Composition and Aerobic Fitness in Female University Students.,"High-intensity interval running (HIIT-R) and high-intensity functional training (HIFT) are two forms of HIIT exercise that are commonly used. The purpose of this study was to determine the effects of HIFT on aerobic capacity and body composition when compared to HIIT-R in females. Twenty healthy, untrained female university students (age 20.5 ± 0.7 year) were randomly assigned to a 12-week HIIT-R or HIFT intervention. The HIIT-R group involved a 30 s maximal shuttle run with a 30 s recovery period, whereas the HIFT involved multiple functional exercises with a 2:1 work-active recovery ratio. Body composition, VO 2 max, and muscle performance were measured before and post intervention. As a result, HIIT-R and HIIT-F stimulated similar improvements in VO 2 max (17.1% ± 5.6% and 12.7% ± 6.7%, respectively,  p  > 0.05). Only the HIIT-F group revealed significant improvements in muscle performance (sit-ups, 16.5% ± 3.1%, standing broad jump 5.1% ± 2.2%,  p  < 0.05). Body fat percentage decreased (17.1% ± 7.4% and 12.6% ± 5.1%, respectively,  p  < 0.05) in both HIIT-R and HIIT-F with no between-group differences. We concluded that HIFT was equally effective in promoting body composition and aerobic fitness compared to HIIT-R. HIFT resulted in improved muscle performance, whereas the HIIT-R protocol demonstrated no gains.",2021,"Only the HIIT-F group revealed significant improvements in muscle performance (sit-ups, 16.5% ± 3.1%, standing broad jump 5.1% ± 2.2%,  p  < 0.05).","['females', 'Twenty healthy, untrained female university students (age 20.5 ± 0.7 year', 'Female University Students']","['HIFT', 'HIIT-R or HIFT intervention', 'High-intensity interval running (HIIT-R) and high-intensity functional training (HIFT', 'Running Compared with Functional High-Intensity Interval Training']","['aerobic capacity and body composition', 'Body composition, VO 2 max, and muscle performance', 'Body Composition and Aerobic Fitness', 'body composition and aerobic fitness', 'Body fat percentage', 'muscle performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.0158302,"Only the HIIT-F group revealed significant improvements in muscle performance (sit-ups, 16.5% ± 3.1%, standing broad jump 5.1% ± 2.2%,  p  < 0.05).","[{'ForeName': 'Yining', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Cardiff School of Sport and Health Sciences, Cardiff Metropolitan University, Cardiff CF5 2YB, UK.'}, {'ForeName': 'Huw D', 'Initials': 'HD', 'LastName': 'Wiltshire', 'Affiliation': 'Cardiff School of Sport and Health Sciences, Cardiff Metropolitan University, Cardiff CF5 2YB, UK.'}, {'ForeName': 'Julien S', 'Initials': 'JS', 'LastName': 'Baker', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Qiaojun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Faculty of Sport Science, Ningbo University, Ningbo 315000, China.'}]",International journal of environmental research and public health,['10.3390/ijerph182111312']
3136,34769814,"Are Resistance Training-Induced BDNF in Hemodialysis Patients Associated with Depressive Symptoms, Quality of Life, Antioxidant Capacity, and Muscle Strength? An Insight for the Muscle-Brain-Renal Axis.","BACKGROUND


Hemodialysis patients are suffering from depressive symptoms. Brain-derived neurotrophic factor (BDNF) levels are negatively associated with depressive symptoms and decrease during a single hemodialysis session. Resistance training (RT) might be an additional non-pharmacological tool to increase BDNF and promote mental health.
METHODS


Two randomized groups of hemodialysis patients: control (CTL,  n  = 76/F36; 66.33 ± 3.88 years) and RT ( n  = 81/F35; 67.27 ± 3.24 years). RT completed six months of training thrice a week under the supervision of strength and conditioning professional immediately before the dialysis session. Training loads were adjusted using the OMNI rating of perceived exertion. The total antioxidant capacity (TROLOX), glutathione (GSH), thiobarbituric acid reactive substance (TBARS), and BDNF levels were analyzed in serum samples. Quality of life (assessed through Medical Outcomes-SF36), and Beck Depression Inventory was applied.
RESULTS


RT improved handgrip strength (21.17 ± 4.38 vs. 27.17 ± 4.34;  p =  0.001) but not for CTL (20.09 ± 5.19 vs. 19.75 ± 5.54;  p =  0.001). Post-training, RT group had higher values as compared to CTL related to TROLOX (RT,680.8 ± 225.2 vs. CTL,589.5 ± 195.9;  p =  0.001) and GSH (RT, 9.33 ± 2.09 vs. CTL,5.00 ± 2.96;  p =  0.001). RT group had lower values of TBARS as compared to CTL at post-training (RT, 11.06 ± 2.95 vs. CTL, 13.66 ± 2.62;  p =  0.001). BDNF increased for RT (11.66 ± 5.20 vs. 19.60 ± 7.23;  p =  0.001), but decreased for CTL (14.40 ± 4.99 vs. 10.84 ± 5.94;  p =  0.001). Quality of life and mental health increased ( p =  0.001) for RT, but did not change for CTL ( p =  0.001). BDNF levels were associated with emotional dimensions of SF36, depressive symptoms, and handgrip ( p  = 0.001).
CONCLUSIONS


RT was effective as a non-pharmacological tool to increased BDNF levels, quality of life, temper the redox balance and decrease depressive symptoms intensity in hemodialysis patients.",2021,"Quality of life and mental health increased ( p =  0.001) for RT, but did not change for CTL ( p =  0.001).","['Hemodialysis patients are suffering from depressive symptoms', 'Two randomized groups of hemodialysis patients', 'hemodialysis patients', 'Hemodialysis Patients']",['Resistance training (RT'],"['total antioxidant capacity (TROLOX), glutathione (GSH), thiobarbituric acid reactive substance (TBARS), and BDNF levels', 'BDNF levels, quality of life, temper the redox balance', 'handgrip strength', 'BDNF', 'emotional dimensions of SF36, depressive symptoms, and handgrip', 'TBARS', 'Depressive Symptoms, Quality of Life, Antioxidant Capacity, and Muscle Strength', 'depressive symptoms intensity', 'OMNI rating of perceived exertion', 'Quality of life and mental health', 'BDNF levels', 'Quality of life (assessed through Medical Outcomes-SF36), and Beck Depression Inventory', 'Brain-derived neurotrophic factor (BDNF) levels']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",,0.015838,"Quality of life and mental health increased ( p =  0.001) for RT, but did not change for CTL ( p =  0.001).","[{'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília 71966-700, Brazil.'}, {'ForeName': 'Hugo de Luca', 'Initials': 'HL', 'LastName': 'Corrêa', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília 71966-700, Brazil.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília 71966-700, Brazil.'}, {'ForeName': 'Andrea Lucena', 'Initials': 'AL', 'LastName': 'Reis', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília 71966-700, Brazil.'}, {'ForeName': 'Fernando Sousa', 'Initials': 'FS', 'LastName': 'Honorato', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília 71966-700, Brazil.'}, {'ForeName': 'Victor Lopes', 'Initials': 'VL', 'LastName': 'Silva', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília 71966-700, Brazil.'}, {'ForeName': 'Michel Kendy', 'Initials': 'MK', 'LastName': 'Souza', 'Affiliation': 'Department of Nephrology, Federal University of São Paulo, São Paulo 04021-001, Brazil.'}, {'ForeName': 'Thaís Branquinho', 'Initials': 'TB', 'LastName': 'de Araújo', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília 71966-700, Brazil.'}, {'ForeName': 'Lucas Santos', 'Initials': 'LS', 'LastName': 'de Gusmão Alves', 'Affiliation': 'Graduate Program in Medicine, Catholic University of Brasília, Brasília 71966-700, Brazil.'}, {'ForeName': 'Caio Victor', 'Initials': 'CV', 'LastName': 'Sousa', 'Affiliation': 'Bouve College of Health Sciences, Northeastern University, Boston, MA 02115, USA.'}, {'ForeName': 'Thaís Lucena', 'Initials': 'TL', 'LastName': 'Reis', 'Affiliation': 'Medical Graduate Program, University of Brasília, Brasília 70910-900, Brazil.'}, {'ForeName': 'Lucas Soares', 'Initials': 'LS', 'LastName': 'de Aguiar', 'Affiliation': 'Medical Graduate Program, University of Brasília, Brasília 70910-900, Brazil.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília 71966-700, Brazil.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília 71966-700, Brazil.'}, {'ForeName': 'Gislane Ferreira', 'Initials': 'GF', 'LastName': 'Melo', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília 71966-700, Brazil.'}, {'ForeName': 'Thiago Santos', 'Initials': 'TS', 'LastName': 'Rosa', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília 71966-700, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph182111299']
3137,34769797,Short-Term Aerobic Exercise Did Not Change Telomere Length While It Reduced Testosterone Levels and Obesity Indexes in PCOS: A Randomized Controlled Clinical Trial Study.,"Metabolic and hormonal outcomes of polycystic ovary syndrome (PCOS) have implications on telomere biology and physical activity may prevent telomere erosion. We sought to observe the effects of continuous (CAT) and intermittent (IAT) aerobic training on telomere length, inflammatory biomarkers, and its correlation with metabolic, hormonal, and anthropometric parameters of PCOS. This randomized controlled clinical trial study included 87 PCOS randomly stratified according to body mass index (BMI) in CAT ( n  = 28), IAT ( n  = 29) and non-training control group (CG,  n  = 30). The exercises were carried out on a treadmill, three times per week for 16 weeks. The participants' anthropometric characteristics and biochemical and hormonal concentrations were measured before and after aerobic training or observation period, as the telomere length that was evaluated using quantitative real-time PCR. Four months of aerobic exercises (CAT or IAT) did not alter telomere length and inflammatory biomarkers in PCOS women. Obesity index as BMI and waist circumference (WC), and inflammatory biomarkers negatively affect telomeres. The hyper-andro-genism measured by testosterone levels was reduced after both exercises (CAT,  p  ≤ 0.001; IAT,  p  = 0.019). In particular, the CAT reduced WC ( p  = 0.045), hip circumference ( p  = 0.032), serum cholesterol ( p  ≤ 0.001), and low-density lipoprotein ( p  = 0.030). Whereas, the IAT decreased WC ( p  = 0.014), waist-to-hip ratio ( p  = 0.012), free androgen index (FAI) ( p  = 0.037). WC ( p  = 0.049) and body fat ( p  = 0.015) increased in the non-training group while total cholesterol was reduced ( p  = 0.010). Booth exercises reduced obesity indices and hyperandrogenism on PCOS women without changes in telomere length or inflammatory biomarkers.",2021,"The hyper-andro-genism measured by testosterone levels was reduced after both exercises (CAT,  p  ≤ 0.001; IAT,  p  = 0.019).","['polycystic ovary syndrome (PCOS', '87 PCOS randomly stratified according to body mass index (BMI) in CAT ( n  = 28), IAT ( n  = 29) and non-training control group (CG,  n  = 30', 'PCOS women']","['aerobic exercises (CAT or IAT', 'continuous (CAT) and intermittent (IAT) aerobic training', 'Short-Term Aerobic Exercise']","['obesity indices and hyperandrogenism', 'anthropometric characteristics and biochemical and hormonal concentrations', 'telomere length and inflammatory biomarkers', 'low-density lipoprotein', 'serum cholesterol', 'IAT decreased WC', 'Obesity index as BMI and waist circumference (WC), and inflammatory biomarkers negatively affect telomeres', 'Testosterone Levels and Obesity Indexes', 'hip circumference', 'waist-to-hip ratio', 'free androgen index (FAI', 'hyper-andro-genism measured by testosterone levels', 'body fat', 'Length', 'total cholesterol', 'telomere length, inflammatory biomarkers, and its correlation with metabolic, hormonal, and anthropometric parameters of PCOS']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0206081', 'cui_str': 'Hyperandrogenization syndrome'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]",87.0,0.0287973,"The hyper-andro-genism measured by testosterone levels was reduced after both exercises (CAT,  p  ≤ 0.001; IAT,  p  = 0.019).","[{'ForeName': 'Victor Barbosa', 'Initials': 'VB', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo 14048-900, Brazil.'}, {'ForeName': 'Daiana Cristina Chielli', 'Initials': 'DCC', 'LastName': 'Pedroso', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo 14048-900, Brazil.'}, {'ForeName': 'Gislaine Satyko', 'Initials': 'GS', 'LastName': 'Kogure', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo 14048-900, Brazil.'}, {'ForeName': 'Iris Palma', 'Initials': 'IP', 'LastName': 'Lopes', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo 14048-900, Brazil.'}, {'ForeName': 'Barbara Aparecida', 'Initials': 'BA', 'LastName': 'Santana', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo 14048-900, Brazil.'}, {'ForeName': 'Hugo Celso', 'Initials': 'HC', 'LastName': 'Dutra de Souza', 'Affiliation': 'Department of Biomechanics, Medicine and Rehabilitation of the Locomotor Apparatus, Ribeirao Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo 14048-900, Brazil.'}, {'ForeName': 'Rui Alberto', 'Initials': 'RA', 'LastName': 'Ferriani', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo 14048-900, Brazil.'}, {'ForeName': 'Rodrigo Tocantins', 'Initials': 'RT', 'LastName': 'Calado', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo 14048-900, Brazil.'}, {'ForeName': 'Cristiana Libardi Miranda', 'Initials': 'CLM', 'LastName': 'Furtado', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo 14048-900, Brazil.'}, {'ForeName': 'Rosana Maria Dos', 'Initials': 'RMD', 'LastName': 'Reis', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo 14048-900, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph182111274']
3138,34769736,Effectiveness of Ergonomic Training to Decrease Awkward Postures during Dental Scaling Procedures: A Randomized Clinical Trial.,"Studies demonstrate that there is a lack of effective ergonomic principles for adopting a neutral posture during the execution of dental procedures. ISO 11.226:2000 Standard, Corr. 1:2006 has been thoroughly evaluated and adapted to the way that dentists work by the European Society of Dental Ergonomics (ESDE). However, after 15 years, no studies that showed strong evidence of effectiveness in reducing the prevalence of awkward posture in applying its parameters within the scope of dental practice were found. The aim of this study was to verify the effectiveness of applying the ergonomic parameters proposed by the European Society of Dental Ergonomics (ESDE) and ISO 11226 in reducing the prevalence of the main awkward postures adopted by female dental surgeons during the execution of dental scaling on a dental mannequin. A randomized clinical trial was carried out with sixty dental surgeons randomly assigned to two groups: the intervention group, who received instructions and theoretical and practical ergonomic training; and the control group, who received the same training only at the end of the study. For data analysis, Software IBM SPSS 27 and RStudio was used. Descriptive statistics were performed to verify the effectiveness of the intervention, and generalized linear models (specifically, generalized estimated equation models) were used. Poisson distribution was carried out with log link function and network analyses. Sixty female dental surgeons participated in the study. Twenty-two were distributed in the intervention group and thirty-eight in the control group. It was found that ergonomic training enabled a 63% reduction in the prevalence of awkward postures and that there was a statistically significant difference ( p  < 0.001) only in the intervention group. The analyses showed that the estimated marginal means of postures not recommended in the groups' initial control, final control, initial intervention, and final intervention were 8.6, 8.2, 9.0, and 3.4, respectively. The relationship of networks analyses of the variables is shown with different profiles in the control and intervention groups, but the same pattern between the groups only vary in the strength and direction of the correlations. It was concluded that the ergonomic training based on the parameters of ISO 11226 and DIN EN 1005-4, and its adaptations to the dental practice provided by the European Society of Dental Ergonomics, as well as recent studies, contributed significantly to reducing the prevalence of awkward postures adopted by female dentists during the simulation of the basic periodontal procedures; however, it was not effective enough to improve the posture of the head and neck.",2021,"The analyses showed that the estimated marginal means of postures not recommended in the groups' initial control, final control, initial intervention, and final intervention were 8.6, 8.2, 9.0, and 3.4, respectively.","['Sixty female dental surgeons participated in the study', 'female dental surgeons during the execution of dental scaling on a dental mannequin', 'sixty dental surgeons']","['Ergonomic Training', 'instructions and theoretical and practical ergonomic training', 'ergonomic training']",['prevalence of awkward postures'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}]","[{'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]",22.0,0.0137092,"The analyses showed that the estimated marginal means of postures not recommended in the groups' initial control, final control, initial intervention, and final intervention were 8.6, 8.2, 9.0, and 3.4, respectively.","[{'ForeName': 'Ana Virginia', 'Initials': 'AV', 'LastName': 'de Santana Sampaio Castilho', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry (FOB/USP), University of São Paulo, Bauru 17012-901, SP, Brazil.'}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'Michel Crosato', 'Affiliation': 'Social Dentistry Department, School of Dentistry (FOUSP), University of São Paulo, São Paulo 05508-000, SP, Brazil.'}, {'ForeName': 'Silvia Helena', 'Initials': 'SH', 'LastName': 'de Carvalho Sales-Peres', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry (FOB/USP), University of São Paulo, Bauru 17012-901, SP, Brazil.'}, {'ForeName': 'Gerson Aparecido', 'Initials': 'GA', 'LastName': 'Foratori Junior', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry (FOB/USP), University of São Paulo, Bauru 17012-901, SP, Brazil.'}, {'ForeName': 'Adriana Rodrigues', 'Initials': 'AR', 'LastName': 'de Freitas Aznar', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry (FOB/USP), University of São Paulo, Bauru 17012-901, SP, Brazil.'}, {'ForeName': 'Rogerio Leone', 'Initials': 'RL', 'LastName': 'Buchaim', 'Affiliation': 'Department of Biological Sciences, Bauru School of Dentistry (FOB/USP), University of São Paulo, Bauru 17012-901, SP, Brazil.'}, {'ForeName': 'Daniela Vieira', 'Initials': 'DV', 'LastName': 'Buchaim', 'Affiliation': 'Postgraduate Program in Structural and Functional Interactions in Rehabilitation, Postgraduate Department, University of Marilia (UNIMAR), Marília 17525-902, SP, Brazil.'}, {'ForeName': 'Dayane Maria Braz', 'Initials': 'DMB', 'LastName': 'Nogueira', 'Affiliation': 'Department of Prosthodontics and Periodontics, Bauru School of Dentistry (FOB/USP), University of São Paulo, Bauru 17012901, SP, Brazil.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'de Souza Bastos Mazuqueli Pereira', 'Affiliation': 'Postgraduate Program in Structural and Functional Interactions in Rehabilitation, Postgraduate Department, University of Marilia (UNIMAR), Marília 17525-902, SP, Brazil.'}, {'ForeName': 'Luis Carlos', 'Initials': 'LC', 'LastName': 'Paschoarelli', 'Affiliation': 'Department of Design, School of Architecture, Arts, Communication and Design, São Paulo State University (UNESP), Bauru 17033-360, SP, Brazil.'}, {'ForeName': 'Eliel Soares', 'Initials': 'ES', 'LastName': 'Orenha', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry (FOB/USP), University of São Paulo, Bauru 17012-901, SP, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph182111217']
3139,34770147,"The Impacts of Coordinated-Bilateral Ball Skills Intervention on Attention and Concentration, and Cardiorespiratory Fitness among Fourth-Grade Students.","BACKGROUND


Both cognitive function and cardiorespiratory fitness are significant correlates of physical and mental health. The exploration of innovative school-based PA intervention strategies to improve cognitive function and cardiorespiratory fitness is of great interest for researchers and school educators. This study aimed at examining the effectiveness of the coordinated-bilateral ball skills (CBBS) intervention in improving cognitive function and cardiorespiratory fitness among 4th-grade students.
METHODS


This study used a two-arm, quasi-experimental research design. The students ( n  = 347) in the intervention group received 16-weeks of CBBS intervention lessons in basketball and soccer. The students ( n  = 348) in the comparison group received 16-weeks of regular basketball and soccer lessons. All participants were pre- and post-tested with the d2 Test of Attention and the Progressive Aerobic Cardiovascular Endurance Run (PACER) test before and after the 16-week CBBS intervention. The data were analyzed by means of descriptive statistics and linear mixed models.
RESULTS


The linear mixed models yielded a marginal significant interaction effect of time with the group in their concentration ( F (1, 680.130)  = 3.272,  p  = 0.071) and a significant interaction effect of time with the group in their attention span ( F (1, 785.108)  = 4.836,  p  = 0.028) while controlling for age and the baseline concentration score. The linear mixed model also revealed a significant main effect of time in focused attention ( F (1670.605)  = 550.096,  p  = 0.000), attention accuracy ( F (1, 663.124)  = 61.542,  p  = 0.000), and cardiorespiratory fitness ( F (1, 680.336)  = 28.145,  p  = 0.000), but no significant interaction effect.
CONCLUSIONS


The CBBS group demonstrated a significant improvement in concentration performance and attention span over time, compared to the comparison group. Both groups improved their focused attention and attention accuracy as well as cardiorespiratory fitness over time. This study suggests that teaching ball skills in team sports for extended periods is instrumental to developing cognitive functions and cardiorespiratory fitness, though the CBBS lessons resulted in greater improvement in concentration performance and attention span.",2021,"The linear mixed model also revealed a significant main effect of time in focused attention ( F (1670.605)  = 550.096,  p  = 0.000), attention accuracy ( F (1, 663.124)  = 61.542,  p  = 0.000), and cardiorespiratory fitness ( F (1, 680.336)  = 28.145,  p  = 0.000), but no significant interaction effect.
","['Fourth-Grade Students', '4th-grade students']","['regular basketball and soccer lessons', 'coordinated-bilateral ball skills (CBBS) intervention', 'CBBS intervention lessons', 'Coordinated-Bilateral Ball Skills Intervention']","['cognitive function and cardiorespiratory fitness', 'attention accuracy', 'Attention and Concentration, and Cardiorespiratory Fitness', 'Progressive Aerobic Cardiovascular Endurance Run (PACER) test', 'attention and attention accuracy', 'concentration performance and attention span', 'cardiorespiratory fitness']","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0423598,"The linear mixed model also revealed a significant main effect of time in focused attention ( F (1670.605)  = 550.096,  p  = 0.000), attention accuracy ( F (1, 663.124)  = 61.542,  p  = 0.000), and cardiorespiratory fitness ( F (1, 680.336)  = 28.145,  p  = 0.000), but no significant interaction effect.
","[{'ForeName': 'Weiyun', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Xiaozan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Physical Education and Health, East China Normal University, Shanghai 200241, China.'}, {'ForeName': 'Xiangli', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Kinesiology, University of Texas at Arlington, Arlington, TX 76109, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Physical Education and Health, East China Normal University, Shanghai 200241, China.'}]",International journal of environmental research and public health,['10.3390/ijerph182111634']
3140,34770116,Effects of a Workplace Sit-Stand Desk Intervention on Health and Productivity.,"In Japan, standing while working has not yet become commonplace, and there is little evidence to support the benefits of standing during the workday. Therefore, this study assessed the relationship between the introduction of a sit-stand desk and its ability to reduce the negative effects of sitting too long and increase employees' general health and productivity. Seventy-four Japanese desk workers participated in this three-month intervention study. Using a randomized controlled trial, the participants were divided into intervention ( n  = 36) and control ( n  = 38) groups. The participant characteristics were ascertained using a questionnaire. The intervention effectiveness was assessed by measuring health-, physical activity-, and work-related outcomes. The results indicate that the intervention group significantly decreased their sitting time at work ( p  = 0.002) and had reduced neck and shoulder pain ( p  = 0.001). There was a significant increase in subjective health ( p  = 0.002), vitality in work-related engagement ( p  < 0.001), and self-rated work performance over a four-week period ( p  = 0.017). These findings indicate a significant difference between the two groups, demonstrating the effectiveness of a sit-stand desk in reducing sedentary behavior and improving workers' health and productivity. Future research can accumulate further evidence of best practice use of sit-stand desks.",2021,"There was a significant increase in subjective health ( p  = 0.002), vitality in work-related engagement ( p  < 0.001), and self-rated work performance over a four-week period ( p  = 0.017).",['Seventy-four Japanese desk workers participated in this three-month intervention study'],['Workplace Sit-Stand Desk Intervention'],"['subjective health', 'health-, physical activity-, and work-related outcomes', 'self-rated work performance', 'sitting time', 'Health and Productivity', ""sedentary behavior and improving workers' health and productivity"", 'vitality in work-related engagement', 'reduced neck and shoulder pain']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}]",74.0,0.00696663,"There was a significant increase in subjective health ( p  = 0.002), vitality in work-related engagement ( p  < 0.001), and self-rated work performance over a four-week period ( p  = 0.017).","[{'ForeName': 'Jiameng', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Faculty of Physical Education, Sendai University, Shibata 9891693, Japan.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Faculty of Physical Education, Sendai University, Shibata 9891693, Japan.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Faculty of Physical Education, Sendai University, Shibata 9891693, Japan.'}, {'ForeName': 'Hyunshik', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Faculty of Physical Education, Sendai University, Shibata 9891693, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph182111604']
3141,34770104,Effect of Differing Durations of High-Intensity Intermittent Activity on Cognitive Function in Adolescents.,"Exercise duration may influence the acute effects on cognition. However, only one study to date has explored the dose-response relationship between exercise duration and cognition in adolescents. Thus, the purpose of this study was to investigate the effect of differing durations of high-intensity intermittent running on cognition in adolescents. Thirty-eight adolescents (23 girls) completed three trials separated by 7 d: 30 min exercise, 60 min exercise, and rest; in a randomised crossover design. The exercise was a modified version of the Loughborough Intermittent Shuttle Test (LIST), which elicited high-intensity intermittent exercise. Cognitive function tests (Stroop test, Sternberg paradigm, Flanker task) were completed 30 min pre, immediately post, and 45 min post exercise. Response times on the incongruent level of the Flanker task improved to a greater extent 45 min following the 30 min LIST, compared to rest ( p  = 0.009). Moreover, response times improved to a greater extent on the three-item level of Sternberg paradigm 45 min following the 30 min LIST, compared to the 60 min LIST ( p  = 0.002) and rest ( p  = 0.013), as well as on the five-item level 45 min following the 30 min LIST, compared to the 60 min LIST ( p  = 0.002). In conclusion, acute exercise enhanced subsequent cognition in adolescents, but overall, 30 min of high-intensity intermittent running is more favourable to adolescents' cognition, compared to 60 min.",2021,"Response times on the incongruent level of the Flanker task improved to a greater extent 45 min following the 30 min LIST, compared to rest ( p  = 0.009).","['Thirty-eight adolescents (23 girls', 'adolescents', 'Adolescents']","['High-Intensity Intermittent Activity', 'Loughborough Intermittent Shuttle Test (LIST), which elicited high-intensity intermittent exercise', 'high-intensity intermittent running']","['Cognitive Function', 'Cognitive function tests (Stroop test, Sternberg paradigm, Flanker task', 'response times']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0430518', 'cui_str': 'Shuttle test'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0035953', 'cui_str': 'Running'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.042049,"Response times on the incongruent level of the Flanker task improved to a greater extent 45 min following the 30 min LIST, compared to rest ( p  = 0.009).","[{'ForeName': 'Lorna M', 'Initials': 'LM', 'LastName': 'Hatch', 'Affiliation': 'Department of Sports Science, School of Science and Technology, Nottingham Trent University, Nottingham NG11 8NS, UK.'}, {'ForeName': 'Karah J', 'Initials': 'KJ', 'LastName': 'Dring', 'Affiliation': 'Department of Sports Science, School of Science and Technology, Nottingham Trent University, Nottingham NG11 8NS, UK.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Williams', 'Affiliation': 'Department of Sports Science, School of Science and Technology, Nottingham Trent University, Nottingham NG11 8NS, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sunderland', 'Affiliation': 'Department of Sports Science, School of Science and Technology, Nottingham Trent University, Nottingham NG11 8NS, UK.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Nevill', 'Affiliation': 'Department of Sports Science, School of Science and Technology, Nottingham Trent University, Nottingham NG11 8NS, UK.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Cooper', 'Affiliation': 'Department of Sports Science, School of Science and Technology, Nottingham Trent University, Nottingham NG11 8NS, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph182111594']
3142,34770096,"Descriptive and Quasi-Experimental Studies about Moral Emotions, Online Empathy, Anger Management, and Their Relations with Key Competencies in Primary Education.","BACKGROUND


Antisocial behaviours make social interactions difficult among students. Moral emotions, online empathy, and anger management are social and emotional variables related to prosocial and antisocial behaviours and health problems. This research aims to assess the impact of Cooperative Project-Based Learning intervention on these three variables for Primary Education students. Additionally, the relations of these variables with key competencies, such as social and emotional competencies and literacy competence, were studied.
METHOD


This research is made up of two studies, descriptive and quasi-experimental, during regular school hours. The descriptive study was carried out with a sample of 516 primary school students and aimed to assess the development of the three variables, taking into account personal and ethnic-cultural factors. The quasi-experimental study, with pre-test and post-test data, had the participation of 145 students to study the incidence of these variables after Cooperative Project-Based Learning intervention in Primary Education.
RESULTS


The results show the relation among the cited variables and the positive impact of the intervention on moral emotions and anger management in the experimental group compared to the control group. Experimental group girls presented higher scores in moral emotions than control group girls.
CONCLUSION


These results open new research lines in relation to the intervention as a programme to prevent the appearance of antisocial behaviours and health problems at school.",2021,"Experimental group girls presented higher scores in moral emotions than control group girls.
","['students', '145 students to study the incidence of these variables after Cooperative Project-Based Learning intervention in Primary Education', 'Primary Education students', '516 primary school students']",['Cooperative Project-Based Learning intervention'],"['social and emotional competencies and literacy competence', 'moral emotions and anger management', 'moral emotions']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]","[{'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0557992', 'cui_str': 'Anger management therapy'}]",516.0,0.0321635,"Experimental group girls presented higher scores in moral emotions than control group girls.
","[{'ForeName': 'Antonio L', 'Initials': 'AL', 'LastName': 'González-Gómez', 'Affiliation': 'Department of Education, University of Cordoba, C/San Alberto Magno, s/n., 14004 Córdoba, Spain.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Farrington', 'Affiliation': 'Institute of Criminology, Cambridge University, Sidgwick Avenue, Cambridge CB3 9DA, UK.'}, {'ForeName': 'Vicente J', 'Initials': 'VJ', 'LastName': 'Llorent', 'Affiliation': 'Department of Education, University of Cordoba, C/San Alberto Magno, s/n., 14004 Córdoba, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph182111584']
3143,34769960,Effects of 1 MHz Therapeutic Ultrasound on Limb Blood Flow and Microvascular Reactivity: A Randomized Pilot Trial.,"A randomized, double-blind, placebo-controlled, cross-over study where continuous therapeutic ultrasound (CUS; at 0.4 W/cm 2 ), pulsed therapeutic ultrasound (PUS; at 20% duty cycle, 0.08 W/cm 2 ), both at 1 MHz, and placebo (equipment on, no energy provided) were randomized and applied over the forearm of the non-dominant arm for 5 min in 10 young, healthy individuals. Absolute and peak forearm blood flow (FBF) were measured via Venous Occlusion Plethysmography. FBF was measured before, halfway, and after (immediately and 5 min after) the therapeutic ultrasound (TUS) intervention. Post-ischemic peak FBF was measured 10 min before and 10 min after the TUS intervention. A two-way repeated measures ANOVA (group × time) was selected to assess differences in FBF before, during, and after TUS treatment, and for peak FBF before and after TUS treatment. FBF increased 5 min after TUS in CUS compared to placebo (2.96 ± 1.04 vs. 2.09 ± 0.63 mL/min/100 mL of tissue,  p  < 0.05). PUS resulted in the greatest increase in Peak FBF at 10 min after US (Δ = 3.96 ± 2.02 mL/min/100 mL of tissue,  p  = 0.06). CUS at 1 MHz was an effective treatment modality for increasing FBF up to 5 min after intervention, but PUS resulted in the greatest increase in peak FBF at 10 min after intervention.",2021,"FBF increased 5 min after TUS in CUS compared to placebo (2.96 ± 1.04 vs. 2.09 ± 0.63 mL/min/100 mL of tissue,  p  < 0.05).","['10 young, healthy individuals']","['therapeutic ultrasound (TUS) intervention', 'MHz Therapeutic Ultrasound', 'placebo (equipment on, no energy provided) were randomized and applied over the forearm of the non-dominant arm for 5 min', 'placebo', 'pulsed therapeutic ultrasound (PUS']","['Limb Blood Flow and Microvascular Reactivity', 'FBF', 'Absolute and peak forearm blood flow (FBF', 'Peak FBF', 'Post-ischemic peak FBF', 'peak FBF']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}]",,0.0517569,"FBF increased 5 min after TUS in CUS compared to placebo (2.96 ± 1.04 vs. 2.09 ± 0.63 mL/min/100 mL of tissue,  p  < 0.05).","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Waters', 'Affiliation': 'Doctor of Physical Therapy Program, College of Health Sciences, The University of Texas at El Paso, El Paso, TX 79968, USA.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Miljkovic', 'Affiliation': 'Doctor of Physical Therapy Program, College of Health Sciences, The University of Texas at El Paso, El Paso, TX 79968, USA.'}, {'ForeName': 'Jozelyn', 'Initials': 'J', 'LastName': 'Rascon', 'Affiliation': 'Doctor of Physical Therapy Program, College of Health Sciences, The University of Texas at El Paso, El Paso, TX 79968, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gomez', 'Affiliation': 'Clinical Applied Physiology Laboratory, College of Health Sciences, The University of Texas at El Paso, El Paso, TX 79902, USA.'}, {'ForeName': 'Alvaro N', 'Initials': 'AN', 'LastName': 'Gurovich', 'Affiliation': 'Doctor of Physical Therapy Program, College of Health Sciences, The University of Texas at El Paso, El Paso, TX 79968, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph182111444']
3144,34769944,"Influence of a Survival Swimming Training Programme on Water Safety Knowledge, Attitudes and Skills: A Randomized Controlled Trial among Young Adults in Sri Lanka.","Drowning among young adults is high in Sri Lanka. Water safety education is a recommended strategy for drowning prevention but is often overlooked for young adults. This study aimed to evaluate the effectiveness of an adapted educational intervention, ""Swim for Safety"" on improving water safety knowledge, attitudes and survival swimming skills among undergraduates (19-28 years) in Sri Lanka. This study employed a parallel-group, two-arm randomized controlled trial design. The intervention group ( n  = 78) received a face-to-face, 12-lesson education programme, and the control group ( n  = 78) received a brochure and weekly mobile phone messages for six consecutive weeks. Baseline, post-intervention and three-month follow-up knowledge, attitudes and skills were evaluated. Knowledge and attitudes were assessed using a self-administered questionnaire and skills were evaluated following a skills assessment protocol. In total 116 participants, 60 intervention group and 56 control group, completed the study. At baseline there were no differences between groups in median scores of water safety knowledge, attitudes and survival swimming skills. The intervention group demonstrated statistically significant increases in median water safety knowledge, attitudes and survival swimming skill scores compared with the control group, following the intervention and maintained at three-month follow-up ( p  < 0.05). The adapted Swim for Safety programme significantly improved water safety knowledge, attitudes, and survival swimming skills among young adults in Sri Lanka. Therefore, it is recommended that the SfS programme be implemented widely to prevent drowning in young adults.",2021,"The intervention group demonstrated statistically significant increases in median water safety knowledge, attitudes and survival swimming skill scores compared with the control group, following the intervention and maintained at three-month follow-up ( p  < 0.05).","['In total 116 participants, 60 intervention group and 56 control group, completed the study', 'young adults in Sri Lanka', 'Young Adults in Sri Lanka', 'young adults', 'undergraduates (19-28 years) in Sri Lanka']","['Survival Swimming Training Programme', 'face-to-face, 12-lesson education programme, and the control group ( n  = 78) received a brochure and weekly mobile phone messages', 'adapted educational intervention, ""Swim for Safety']","['median water safety knowledge, attitudes and survival swimming skill scores', 'water safety knowledge, attitudes and survival swimming skills', 'median scores of water safety knowledge, attitudes and survival swimming skills', 'water safety knowledge, attitudes, and survival swimming skills', 'Water Safety Knowledge, Attitudes and Skills']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",116.0,0.0276589,"The intervention group demonstrated statistically significant increases in median water safety knowledge, attitudes and survival swimming skill scores compared with the control group, following the intervention and maintained at three-month follow-up ( p  < 0.05).","[{'ForeName': 'Jeewanthika', 'Initials': 'J', 'LastName': 'Ekanayaka', 'Affiliation': 'Department of Nursing, Faculty of Allied Health Sciences, University of Peradeniya, Peradeniya 20400, Sri Lanka.'}, {'ForeName': 'Chan Kim', 'Initials': 'CK', 'LastName': 'Geok', 'Affiliation': 'Department of Nursing, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Kota Samarahan 94300, Sarawak, Malaysia.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Matthews', 'Affiliation': 'Research and Health Promotion Department, Life Saving Victoria, 200 The Boulevard, Port Melbourne, VIC 3207, Australia.'}, {'ForeName': 'Samath D', 'Initials': 'SD', 'LastName': 'Dharmaratne', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, University of Peradeniya, Peradeniya 20400, Sri Lanka.'}]",International journal of environmental research and public health,['10.3390/ijerph182111428']
3145,34769943,Evaluation of Silodosin and Pelvic Floor Muscle Training in Men with Benign Prostatic Hyperplasia and Overactive Bladder (Silodosing) Study Protocol (Spirit Compliant).,"The aim of our study will be to evaluate the effect of combining pelvic floor muscle training (PFMT) with the urgency-suppression technique and silodosin in comparison with silodosin alone in men with Benign Prostatic Hyperplasia (BPH) and Overactive Bladder (OAB) after 12 weeks of treatment. The primary outcome will be a change in the number of voidings and intensity of urgencies over 24 h using a micturition diary, and the secondary outcomes will be a change in lower urinary tract symptoms, a change in incontinence quality of life, a change in patients' global impression of improvement, and a lower incidence of adverse events. A randomized intervention parallel multicenter study will be conducted in collaboration with 45 urological clinics at the national level. Patients will be assigned at a 1:1 ratio to the experimental and control groups using simple randomization according to odd and even patient sequence numbers in each ambulatory clinic. The experimental group will receive oral silodosin at a daily dose of 8 mg once daily and pelvic floor muscle training (PFMT) 5 times a week for 20-30 min a day, for 12 weeks. The control group will receive oral treatment with silodosin at a daily dose of 8 mg once daily for 12 weeks. The study protocol presents the starting points and design of a randomized, interventional, parallel, multicenter study looking at the effect of a combination of silodosin and PFMT versus silodosin treatment in men with BPH and OAB.",2021,"The primary outcome will be a change in the number of voidings and intensity of urgencies over 24 h using a micturition diary, and the secondary outcomes will be a change in lower urinary tract symptoms, a change in incontinence quality of life, a change in patients' global impression of improvement, and a lower incidence of adverse events.","['men with Benign Prostatic Hyperplasia (BPH) and Overactive Bladder (OAB) after 12 weeks of treatment', 'collaboration with 45 urological clinics at the national level', 'Men with Benign Prostatic Hyperplasia and Overactive Bladder (Silodosing) Study Protocol (Spirit Compliant', 'men with BPH and OAB']","['pelvic floor muscle training (PFMT', 'silodosin and PFMT versus silodosin', 'silodosin', 'Silodosin and Pelvic Floor Muscle Training', 'silodosin alone', 'oral silodosin']","['number of voidings and intensity of urgencies over 24 h using a micturition diary', ""lower urinary tract symptoms, a change in incontinence quality of life, a change in patients' global impression of improvement, and a lower incidence of adverse events""]","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C0566588', 'cui_str': 'Compliant'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C1870115', 'cui_str': 'silodosin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",45.0,0.114913,"The primary outcome will be a change in the number of voidings and intensity of urgencies over 24 h using a micturition diary, and the secondary outcomes will be a change in lower urinary tract symptoms, a change in incontinence quality of life, a change in patients' global impression of improvement, and a lower incidence of adverse events.","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Hagovska', 'Affiliation': 'Department of Physiatry, Balneology, and Medical Rehabilitation, Faculty of Medicine, PJ Safarik University, 040 01 Kosice, Slovakia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Svihra', 'Affiliation': 'Department of Urology, Jessenius Faculty of Medicine, Martin, Comenius University, 814 99 Bratislava, Slovakia.'}]",International journal of environmental research and public health,['10.3390/ijerph182111426']
3146,34769937,The Influence of Virtual Forest Walk on Physiological and Psychological Responses.,"The authors of this paper sought to investigate the impact of virtual forest therapy based on realistic versus dreamlike environments on reducing stress levels. Today, people are facing an increase in stress levels in everyday life, which may be due to personal life, work environment, or urban area expansion. Previous studies have reported that urban environments demand more attention and mental workload than natural environments. However, evidence for the effects of natural environments as virtual forest therapy on stress levels has not yet been fully explored. In this study, a total of 20 healthy participants completed a letter-detection test to increase their stress level and were then randomly assigned to two different virtual environments representing realistic and dreamlike graphics. The participants' stress levels were assessed using two physiological methods that measured heart rate and skin conductance levels and one psychological method through the Profile of Mood States (POMS) questionnaire. These indicators were analyzed using a sample  t -test and a one-way analysis of variance. The results showed that virtual forest environments could have positive stress-relieving effects. However, realistic graphics were more efficient in reducing stress. These findings contribute to growing forest therapy concepts and provide new directions for future forest therapy research.",2021,"However, realistic graphics were more efficient in reducing stress.",['20 healthy participants completed a letter-detection test to increase their stress level'],"['Virtual Forest Walk', 'virtual environments representing realistic and dreamlike graphics']","['Physiological and Psychological Responses', 'stress levels', 'heart rate and skin conductance levels and one psychological method through the Profile of Mood States (POMS) questionnaire', 'positive stress-relieving effects']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]","[{'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",20.0,0.0344159,"However, realistic graphics were more efficient in reducing stress.","[{'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Alyan', 'Affiliation': 'Department of Computer and Information Sciences, University Teknologi PETRONAS, Seri Iskandar 32610, Perak, Malaysia.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Combe', 'Affiliation': 'Department of Computer and Information Sciences, University Teknologi PETRONAS, Seri Iskandar 32610, Perak, Malaysia.'}, {'ForeName': 'Dayang Rohaya', 'Initials': 'DR', 'LastName': 'Awang Rambli', 'Affiliation': 'Department of Computer and Information Sciences, University Teknologi PETRONAS, Seri Iskandar 32610, Perak, Malaysia.'}, {'ForeName': 'Suziah', 'Initials': 'S', 'LastName': 'Sulaiman', 'Affiliation': 'Department of Computer and Information Sciences, University Teknologi PETRONAS, Seri Iskandar 32610, Perak, Malaysia.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Merienne', 'Affiliation': 'Arts et Metiers Institute of Technology, LISPEN, HESAM Université, F-71100 Chalon-sur-Saône, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Diyana', 'Affiliation': 'School of Multimedia Technology and Communication, University Utara Malaysia, Sintok 06010, Kedah, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph182111420']
3147,34773608,Comparison of Pharmacokinetics and Pharmacodynamics of Inhaled Technosphere Insulin and Subcutaneous Insulin Lispro in the Treatment of Type 1 Diabetes Mellitus.,"BACKGROUND


This study was performed to satisfy a US Food and Drug Administration post-marketing requirement to compare the dose responses for Technosphere ®  Insulin (TI; MannKind Corporation, Westlake Village, CA, USA) and subcutaneous insulin lispro (LIS) across a wide range of doses.
OBJECTIVES


This single-center, open-label, randomized, cross-over study defined the pharmacokinetic/pharmacodynamic curves for inhaled TI vs subcutaneous LIS in persons with type 1 diabetes mellitus.
METHODS


Each volunteer received six treatments while undergoing euglycemic clamps: three doses of TI (10, 30 and 120 U) and LIS (8, 30, and 90 U). Primary endpoint was area under the glucose infusion rate vs time curve from start of treatment administration to end of clamp. Key secondary endpoints included readouts of insulin exposure and timing of pharmacokinetic/pharmacodynamic profiles.
RESULTS


Insulin exposure was more than dose proportional, increasing with dose 1.08  for LIS and dose 1.35  for TI. Time to reach 10% of the maximum glucose infusion rate was 7 to 15 min for TI vs 21 to 38 min for LIS. End of effect was dose dependent for both treatments, ranging from 2 to 6 h (TI) and 5 to 10 h (LIS). Glucose infusion rate exhibited saturation for both treatments. Technosphere Insulin produced a lesser total effect per unit insulin than LIS due to its faster absorption and correspondingly shorter duration of exposure. The difference was large enough to require significantly different doses to achieve the same total effect.
CONCLUSIONS


Technosphere Insulin has a considerably faster onset and shorter duration of action than LIS. Consequently, the overall effect of TI is smaller than that of LIS and unit-for-unit dose conversion is not appropriate.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02470637; 12 June, 2015.",2021,"RESULTS


Insulin exposure was more than dose proportional, increasing with dose 1.08  for LIS and dose 1.35  for TI.","['Type 1 Diabetes Mellitus', 'persons with type 1 diabetes mellitus']","['inhaled TI vs subcutaneous LIS', 'six treatments while undergoing euglycemic clamps: three doses of TI', 'Technosphere Insulin', 'Inhaled Technosphere Insulin and Subcutaneous Insulin Lispro']","['readouts of insulin exposure and timing of pharmacokinetic/pharmacodynamic profiles', 'maximum glucose infusion rate', 'area under the glucose infusion rate vs time curve']","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.116308,"RESULTS


Insulin exposure was more than dose proportional, increasing with dose 1.08  for LIS and dose 1.35  for TI.","[{'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Grant', 'Affiliation': 'MannKind Corporation, 30930 Russell Ranch Rd, Suite 300, Westlake Village, CA, 91362, USA. mgrant@mannkindcorp.com.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Baughman', 'Affiliation': 'Takeda Pharmaceutical Company Ltd, Lexington, MA, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-021-01084-0']
3148,34773606,Finerenone Dose-Exposure-Response for the Primary Kidney Outcome in FIDELIO-DKD Phase III: Population Pharmacokinetic and Time-to-Event Analysis.,"BACKGROUND


Finerenone is a nonsteroidal selective mineralocorticoid receptor antagonist that recently demonstrated efficacy in delaying chronic kidney disease progression and reducing cardiovascular events in patients with chronic kidney disease and type 2 diabetes in FIDELIO-DKD, where 5734 patients were randomized 1:1 to receive either titrated finerenone doses of 10 or 20 mg once daily or placebo, with a median follow-up of 2.6 years.
METHODS


Nonlinear mixed-effects population pharmacokinetic models were used to analyze the pharmacokinetics in FIDELIO-DKD, sparsely sampled in all subjects receiving finerenone. Post-hoc model parameter estimates together with dosing histories allowed the computation of individual exposures used in subsequent parametric time-to-event analyses of the primary kidney outcome.
RESULTS


The population pharmacokinetic model adequately captured the typical pharmacokinetics of finerenone and its variability. Either covariate effects or multivariate forward-simulations in subgroups of interest were contained within the equivalence range of 80-125% around typical exposure. The exposure-response relationship was characterized by a maximum effect model estimating a low half-maximal effect concentration at 0.166 µg/L and a maximal hazard decrease at 36.1%. Prognostic factors for the treatment-independent chronic kidney disease progression risk included a low estimated glomerular filtration rate and a high urine-to-creatinine ratio increasing the risk, while concomitant sodium-glucose transport protein 2 inhibitor use decreased the risk. Importantly, no sodium-glucose transport protein 2 inhibitor co-medication-related modification of the finerenone treatment effect per se could be identified.
CONCLUSIONS


None of the tested pharmacokinetic covariates had clinical relevance in FIDELIO-DKD. Finerenone effects on kidney outcomes approached saturation towards 20 mg once daily and sodium-glucose transport protein 2 inhibitor use provided additive benefits.",2021,"Prognostic factors for the treatment-independent chronic kidney disease progression risk included a low estimated glomerular filtration rate and a high urine-to-creatinine ratio increasing the risk, while concomitant sodium-glucose transport protein 2 inhibitor use decreased the risk.","['patients with chronic kidney disease and type 2 diabetes in FIDELIO-DKD, where 5734 patients']","['titrated finerenone doses of 10 or 20\xa0mg once daily or placebo', 'finerenone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C4045511', 'cui_str': 'finerenone'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],5734.0,0.0195742,"Prognostic factors for the treatment-independent chronic kidney disease progression risk included a low estimated glomerular filtration rate and a high urine-to-creatinine ratio increasing the risk, while concomitant sodium-glucose transport protein 2 inhibitor use decreased the risk.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van den Berg', 'Affiliation': 'Leiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Ruppert', 'Affiliation': 'Leiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.'}, {'ForeName': 'Emir', 'Initials': 'E', 'LastName': 'Mesic', 'Affiliation': 'Leiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.'}, {'ForeName': 'Nelleke', 'Initials': 'N', 'LastName': 'Snelder', 'Affiliation': 'Leiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Seelmann', 'Affiliation': 'Pharmacometrics, Pharmaceuticals R&D, Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Heinig', 'Affiliation': 'Clinical Pharmacology, Pharmaceuticals R&D, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'Clinical Development, Pharmaceuticals R&D, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Garmann', 'Affiliation': 'Pharmacometrics, Pharmaceuticals R&D, Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Lippert', 'Affiliation': 'Pharmacometrics, Pharmaceuticals R&D, Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissing', 'Affiliation': 'Pharmacometrics, Pharmaceuticals R&D, Bayer AG, Leverkusen, Germany. thomas.eissing@bayer.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-021-01082-2']
3149,34773596,Functional Near-Infrared Spectroscopy as a Target Navigator for rTMS Modulation in Patients with Hemiplegia: A Randomized Control Study.,"INTRODUCTION


Although repetitive transcranial magnetic stimulation (rTMS) is efficacious for motor neuromodulation in stroke survivors, high interindividual variability for responsiveness remains a concern. Target probing on the skull using a proper brain-mapping technique may help overcome this challenge. This study assessed the feasibility of functional near-infrared spectroscopy (fNIRS) as a target navigator in rTMS treatment for motor facilitation in patients with stroke.
METHODS


Fifty-one patients with stroke were enrolled in this randomized controlled study. The patients were assigned to three groups: fNIRS-guided rTMS treatment (fNIRS group, n = 20), motor evoked potential (MEP)-guided rTMS treatment (MEP group, n = 16), and sham (n = 15) group. Motor assessments, including Fugl-Meyer Assessment (FMA), Wolf Motor Function Test (WMFT), and muscle strength, were conducted at baseline and after the 10-session rTMS treatment.
RESULTS


The fNIRS-guided hotspot (fNIRS-HS) was obtained for each patient, even those for whom the MEP-guided hotspot was undetectable. Both intervention groups exhibited significant improvements in muscle strength, FMA, and WMFT scores (P < 0.001) compared with the sham group. The fNIRS group achieved significantly greater improvement in elbow function (P = 0.001) than the MEP group.
CONCLUSION


fNIRS can be a reliable tool for hotspot navigation for motor neuromodulation in patients with stroke. With high sensitivity to cortical oxygenation changes, this navigation system achieved a superior outcome to the traditional MEP-based method in patients with stroke. fNIRS-based systems may also facilitate the integration of machine learning, thus enabling precision medicine for neuromodulation.
TRIAL REGISTRATION


https://clinicaltrials.gov ; Unique identifier: NCT02006615.",2021,"The fNIRS group achieved significantly greater improvement in elbow function (P = 0.001) than the MEP group.
","['Patients with Hemiplegia', 'patients with stroke', 'Fifty-one patients with stroke']","['functional near-infrared spectroscopy (fNIRS', 'repetitive transcranial magnetic stimulation (rTMS', 'fNIRS-guided rTMS treatment (fNIRS group, n\u2009=\u200920), motor evoked potential (MEP)-guided rTMS treatment (MEP group, n\u2009=\u200916), and sham']","['elbow function', 'Motor assessments, including Fugl-Meyer Assessment (FMA), Wolf Motor Function Test (WMFT), and muscle strength', 'muscle strength, FMA, and WMFT scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",51.0,0.0390044,"The fNIRS group achieved significantly greater improvement in elbow function (P = 0.001) than the MEP group.
","[{'ForeName': 'Pang-Wei', 'Initials': 'PW', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chia-Feng', 'Initials': 'CF', 'LastName': 'Lu', 'Affiliation': 'Department of Biomedical Imaging and Radiological Sciences, School of Biomedical Science and Engineering, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Shin-Tsu', 'Initials': 'ST', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Po-Yi', 'Initials': 'PY', 'LastName': 'Tsai', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan. pytsai@vghtpe.gov.tw.'}]",Neurology and therapy,['10.1007/s40120-021-00300-0']
3150,34773579,Arterial Stiffness Alterations in Simulated Microgravity and Reactive Sledge as a Countermeasure.,"INTRODUCTION


Experiments during spaceflight and simulated microgravity as head-down tilt bedrest, demonstrated the role of arterial stiffness among others, in microgravity induced cardiovascular pathologies and emphasized the need for a robust countermeasure.
AIM


The purpose of the present study was to evaluate the use of a new countermeasure, consisting of a high intensity Reactive Sledge (RSL) jumps training protocol, to counteract changes in arterial stiffness during long term head down tilt bedrest (LTBR).
METHODS


The participants enrolled in the study were 23 male, healthy volunteers, aged between 20 and 45 years, subjected to LTBR for 60 days and randomly assigned either to a control (11) or to a training sledge (12) group using RSL 3-4 times per week, as a countermeasure. Recorded values were systolic and diastolic blood pressure, heart rate and the user's arterial stiffness index.
RESULTS


Compared to baseline measurements, there was a deterioration in the values of arterial stiffness, systolic and diastolic blood pressure and heart rate, in both groups until day 35 of LTBR, interpreted as adaptation to the microgravity environment. From this day until the end of the experiment, arterial stiffness of the control group was constantly fluctuating, while constantly improving for the training group. During the recovery period, arterial stiffness values returned to the pre-experimental levels in both groups.
CONCLUSIONS


Overall, arterial stiffness increased the longer the time spent in LTBR and the countermeasure was partially effective in preventing the observed phenomenon. German Clinical Trials Register (DRKS), DRKS00012946, September 18, 2017, retrospectively registered.",2021,"Compared to baseline measurements, there was a deterioration in the values of arterial stiffness, systolic and diastolic blood pressure and heart rate, in both groups until day 35 of LTBR, interpreted as adaptation to the microgravity environment.","['participants enrolled in the study were 23 male, healthy volunteers, aged between 20 and 45\xa0years, subjected to LTBR for 60\xa0days']","['control (11) or to a training sledge (12) group using RSL', 'high intensity Reactive Sledge (RSL) jumps training protocol']","['arterial stiffness, systolic and diastolic blood pressure and heart rate', 'Overall, arterial stiffness', 'arterial stiffness values', 'arterial stiffness', ""systolic and diastolic blood pressure, heart rate and the user's arterial stiffness index""]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242683', 'cui_str': 'Head-Down Tilt'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",23.0,0.0448191,"Compared to baseline measurements, there was a deterioration in the values of arterial stiffness, systolic and diastolic blood pressure and heart rate, in both groups until day 35 of LTBR, interpreted as adaptation to the microgravity environment.","[{'ForeName': 'Agisilaos', 'Initials': 'A', 'LastName': 'Krachtis', 'Affiliation': 'Greek Aerospace Medical Association and Space Research (GASMA-SR), Ethnikis Antistasis 44, Kalamaria, 5513, Thessaloniki, Greece.'}, {'ForeName': 'Aliki', 'Initials': 'A', 'LastName': 'Karkala', 'Affiliation': 'Greek Aerospace Medical Association and Space Research (GASMA-SR), Ethnikis Antistasis 44, Kalamaria, 5513, Thessaloniki, Greece.'}, {'ForeName': 'Christos A', 'Initials': 'CA', 'LastName': 'Frantzidis', 'Affiliation': 'Biomedical Engineering and Aerospace Neuroscience (BEAN), Laboratory of Medical Physics, Medical School, Aristotle University of Thessaloniki, 54124, Thessaloniki, Greece.'}, {'ForeName': 'Polyxeni T', 'Initials': 'PT', 'LastName': 'Gkivogkli', 'Affiliation': 'Biomedical Engineering and Aerospace Neuroscience (BEAN), Laboratory of Medical Physics, Medical School, Aristotle University of Thessaloniki, 54124, Thessaloniki, Greece.'}, {'ForeName': 'Aristea I', 'Initials': 'AI', 'LastName': 'Ladas', 'Affiliation': 'CITY College, International Faculty of the University of Sheffield, South East European Research Centre (SEERC), Proxenou Koromila 24, 54622, Thessaloniki, Greece.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Strollo', 'Affiliation': 'Elle-Di and San Raffaele Research Institute, Via degli Scipioni 175, 00192, Rome, Italy.'}, {'ForeName': 'Chrysoula', 'Initials': 'C', 'LastName': 'Kourtidou-Papadeli', 'Affiliation': 'Greek Aerospace Medical Association and Space Research (GASMA-SR), Ethnikis Antistasis 44, Kalamaria, 5513, Thessaloniki, Greece. papadc@auth.gr.'}]",High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension,['10.1007/s40292-021-00486-2']
3151,34773489,Patient-reported results of simultaneous direct anterior approach and posterolateral approach total hip arthroplasties performed in the same patients.,"BACKGROUND


Several studies have compared clinical results of the direct anterior approach (DAA) and the posterolateral approach (PLA) in total hip arthroplasty (THA); however, the effect of the surgical approach on outcome of THA remains controversial. Most of these studies used two distinct groups of patients, and THAs were performed by different surgeons, using different designs of prosthesis. These confounding factors may limit the strength of the conclusions. The purpose of this prospective, simultaneous bilateral randomized study was to investigate whether patients would perceive the difference between the direct anterior approach (DAA) and the posterolateral approach (PLA) after THA.
MATERIALS AND METHODS


Among 20 patients scheduled to undergo same-day bilateral THA between October 2017 and August 2019, one hip was randomly assigned to DAA and the other to PLA. Patient-reported outcome measures [Hip disability and Osteoarthritis Outcome Score (HOOS), patients' hip pain on mobilization] and physician-assessed measures [Harris Hip Score (HHS), operative time, intraoperative blood loss, cup abduction, cup anteversion, stem orientation, and incidence of complications (intraoperative fracture, nerve damage, incisional problem, or postoperative dislocation)] were compared.
RESULTS


All patients were followed up for 12 months. Hip pain was significantly less with DAA-THA compared with PLA-THA at postoperative 1, 3, and 7 days (p < 0.05). There was no clinical difference between DAA-THA and PLA-THA in terms of the VAS, HOOS, or HSS at 6 weeks and 3, 6, and 12 months postoperatively (p > 0.05). DAA-THA had a longer operative time and shorter length of incision compared with PLA-THA. There was no statistical difference between DAA-THA and PLA-THA in terms of intraoperative blood loss, cup abduction, cup anteversion, stem orientation, and perioperative complications (p > 0.05).
CONCLUSIONS


This study demonstrates that DAA-THA and PLA-THA could provide comparable HHS and HOOS at all follow-ups. Compared with PLA-THA, DAA-THA is associated with less hip pain within postoperative 7 days and shorter incision length, but longer operative time.
LEVEL OF EVIDENCE


Level I, therapeutic study. Trial registration Chinese Clinical Trail Registry, ChiCTR1800019816. Registered 30 November 2018-retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=30863.",2021,"There was no statistical difference between DAA-THA and PLA-THA in terms of intraoperative blood loss, cup abduction, cup anteversion, stem orientation, and perioperative complications (p > 0.05).
","['20 patients scheduled to undergo same-day bilateral THA between October 2017 and August 2019, one hip', 'total hip arthroplasty (THA']",['direct anterior approach (DAA) and the posterolateral approach (PLA'],"['operative time', ""Hip disability and Osteoarthritis Outcome Score (HOOS), patients' hip pain on mobilization] and physician-assessed measures [Harris Hip Score (HHS), operative time, intraoperative blood loss, cup abduction, cup anteversion, stem orientation, and incidence of complications (intraoperative fracture, nerve damage, incisional problem, or postoperative dislocation"", 'Hip pain', 'operative time and shorter length of incision', 'shorter incision length', 'VAS, HOOS, or HSS', 'hip pain', 'intraoperative blood loss, cup abduction, cup anteversion, stem orientation, and perioperative complications']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C2960303', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0436007', 'cui_str': 'Intraoperative fracture'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",20.0,0.0577811,"There was no statistical difference between DAA-THA and PLA-THA in terms of intraoperative blood loss, cup abduction, cup anteversion, stem orientation, and perioperative complications (p > 0.05).
","[{'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedic Surgery, The Affiliated Hospital of Xuzhou Medical University, No. 99 Huaihai West Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': ""Department of Orthopedic Surgery, The Affiliated Hospital of Xuzhou Medical University, No. 99 Huaihai West Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Kai-Jin', 'Initials': 'KJ', 'LastName': 'Guo', 'Affiliation': ""Department of Orthopedic Surgery, The Affiliated Hospital of Xuzhou Medical University, No. 99 Huaihai West Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Guo-Chun', 'Initials': 'GC', 'LastName': 'Zha', 'Affiliation': ""Department of Orthopedic Surgery, The Affiliated Hospital of Xuzhou Medical University, No. 99 Huaihai West Road, Xuzhou, 221002, Jiangsu, People's Republic of China. 41049015@qq.com.""}]",Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology,['10.1186/s10195-021-00611-w']
3152,34773837,Comparative metabolomic study of high-flux hemodialysis and high volume online hemodiafiltration in the removal of uremic toxins using  1 H NMR spectroscopy.,"Uremic toxins (UTs) accumulate in the circulation of patients with chronic kidney disease (CKD). High volume hemodiafiltration (HDF) improves clearance of low and medium molecular weight UTs compared to HD. The present study is a post-hoc analysis comparing the metabolomic profile in serum from patients under high flux HD (hf-HD) and HDF in HDFIT, a multicentric randomized controlled trial (RCTs). Per protocol, serum samples were collected pre- and post- dialysis treatments at randomization (baseline) and at the end of the follow up (6 months) and stored in a biorepository. Random (pre- and post-dialysis) samples from nine patients in study arm were selected at baseline and at the end of the follow up. To compare the samples, 26 possibly matching metabolites were identified by a t-test among the four groups using  1 H nuclear magnetic resonance (NMR). To evaluate the comparison between the modalities is a single treatment session, the clearance rates (CRs) of each metabolite were calculated based on pre-dialysis and post-dialysis samples. In addition, to evaluate to effect of UT removal during the trial follow up period, the pre-dialysis metabolite concentrations at the baseline and at 6 months were compared among the two arms of the study. There was no significant difference between in the single session CRs of metabolites when hf-HD and HDF were compared. On the other hand, the comparison between baseline and 6-month (long-term evolution) led to the identification of 16 metabolites that differentiated the hf-HD and the HDF evolutions. Most of these 16 metabolites are involved in several important metabolic pathways, such as metabolism of phenylalanine and biosynthesis of phenylalanine, tyrosine, and tryptophan, which are related to UTs and cardiovascular disease development. Although no difference was observed between hf-HD and HDF samples before and after a single session, concentrations of CKD-relevant metabolites and associated pathologies were stable in the HDF samples, but not in the hf-HD samples, over the six-month period, suggesting that HDF enhances long-term stability.",2021,High volume hemodiafiltration (HDF) improves clearance of low and medium molecular weight UTs compared to HD.,"['patients with chronic kidney disease (CKD', 'patients under high flux HD (hf-HD) and HDF in HDFIT']","['high-flux hemodialysis and high volume online hemodiafiltration', 'High volume hemodiafiltration (HDF']","['clearance rates (CRs) of each metabolite', 'pre-dialysis metabolite concentrations', 'HDF enhances long-term stability', 'concentrations of CKD-relevant metabolites and associated pathologies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",26.0,0.0338387,High volume hemodiafiltration (HDF) improves clearance of low and medium molecular weight UTs compared to HD.,"[{'ForeName': 'Andressa Flores', 'Initials': 'AF', 'LastName': 'Santos', 'Affiliation': 'Experimental Nephrology Laboratory, Basic Pathology Department, Universidade Federal do Paraná, Curitiba, PR, Brazil; Clinical Analysis Department, Universidade Federal do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Elberth Manfron', 'Initials': 'EM', 'LastName': 'Schiefer', 'Affiliation': 'Experimental Nephrology Laboratory, Basic Pathology Department, Universidade Federal do Paraná, Curitiba, PR, Brazil; Graduate Program in Electrical and Computer Engineering, Universidade Tecnológica Federal do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Guilherme Lanzi', 'Initials': 'GL', 'LastName': 'Sassaki', 'Affiliation': 'Biochemistry Department, Universidade Federal do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Leociley', 'Initials': 'L', 'LastName': 'Menezes', 'Affiliation': 'Biochemistry Department, Universidade Federal do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': 'Experimental Nephrology Laboratory, Basic Pathology Department, Universidade Federal do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Regiane', 'Initials': 'R', 'LastName': 'Cunha', 'Affiliation': 'Experimental Nephrology Laboratory, Basic Pathology Department, Universidade Federal do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Souza', 'Affiliation': 'Clinical Analysis Department, Universidade Federal do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pecoits-Filho', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Programa de Pós-Graduação em Ciências da Saúde, Curitiba, Brazil.'}, {'ForeName': 'Andréa E M', 'Initials': 'AEM', 'LastName': 'Stinghen', 'Affiliation': 'Experimental Nephrology Laboratory, Basic Pathology Department, Universidade Federal do Paraná, Curitiba, PR, Brazil. Electronic address: andreastinghen@ufpr.br.'}]",Journal of pharmaceutical and biomedical analysis,['10.1016/j.jpba.2021.114460']
3153,34773803,Berberine treatment for weight gain in patients with schizophrenia by regulating leptin rather than adiponectin.,"BACKGROUND


Berberine could improve antipsychotic-induced weight gain in obese cell lines and animal models. This study aimed to exam the effect of berberine on weight gain in patients with schizophrenia.
METHODS


Each subject who met DSM-IV-TR criteria for schizophrenia had been on stable dose of a single antipsychotic for at least one month. In an 8-week randomized, double-blind, placebo-controlled study, subjects received either berberine (900 mg per day) or placebo. Anthropometric parameters, leptin and adiponectin were measured at baseline, week 4, and week 8.
RESULTS


A total of 65 patients were enrolled, 49 of which completed the treatment. At the 8th week, the mean weight of patients in the berberine group (N = 27) lost 1.10 kg, while in the placebo group (N = 22) gained 1.45 kg. There were significant differences in body weight (F time*group =10.493, P = 0.001), BMI (F time*group =9.344, P = 0.002) and leptin (F time*group =6.265, P = 0.003). Further, the change of leptin had significant positive correlations with the changes of body weight(r = 0.395, P = 0.041) and BMI(r = 0.389, P = 0.045). There was no significant difference in adverse events between the two groups (P > 0.05).
CONCLUSION


This study suggests that berberine is a potential weight loss and weight maintenance drug for patients with schizophrenia. The effect of berberine on weight gain may be related to the regulation of leptin, but not adiponectin.",2021,"There were significant differences in body weight (F time*group =10.493, P = 0.001), BMI (F time*group =9.344, P = 0.002) and leptin (F time*group =6.265, P = 0.003).","['patients with schizophrenia', 'A total of 65 patients were enrolled, 49 of which completed the treatment', 'patients with schizophrenia by regulating leptin rather than adiponectin']","['Berberine treatment', 'berberine', 'placebo']","['leptin', 'body weight', 'adverse events', 'BMI', 'mean weight', 'weight gain', 'Anthropometric parameters, leptin and adiponectin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]","[{'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]",65.0,0.170228,"There were significant differences in body weight (F time*group =10.493, P = 0.001), BMI (F time*group =9.344, P = 0.002) and leptin (F time*group =6.265, P = 0.003).","[{'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Anding Hospital, Mental Health Center of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Anding Hospital, Mental Health Center of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Anding Hospital, Mental Health Center of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Anding Hospital, Mental Health Center of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yongping', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Anding Hospital, Mental Health Center of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Mental Health, Suzhou Psychiatric Hospital, The Affiliated Guangji Hospital of Soochow University, Suzhou, Jiangsu, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Jia', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Anding Hospital, Mental Health Center of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Anding Hospital, Mental Health Center of Tianjin Medical University, Tianjin, China. Electronic address: jieli@tjmhc.com.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2021.102896']
3154,34769994,A Home-Based Multimedia Pulmonary Rehabilitation Program Improves Clinical Symptoms and Physical Performance of Patients with Chronic Obstructive Pulmonary Disease.,"Home-based pulmonary rehabilitation can decrease symptoms in chronic obstructive pulmonary disease (COPD) patients. The purpose of this study was to compare the effects of a home-based pulmonary rehabilitation by instructive multimedia in the form of videos and flip charts on clinical symptoms and exercise performance in COPD patients. An eight-week home-based pulmonary rehabilitation program was performed with twenty COPD patients older than 60 years of age with moderate to severe stages. They were separated into two groups: a multimedia group ( n  = 10) and a control group, which was only provided with telephone monitoring ( n  = 10). Clinical symptoms were measured by using the clinical COPD questionnaire (CCQ), and exercise performance was measured using a six-minute walk test (6MWT) and an upper-lower limb muscle strengthening test. After 8 weeks, the results showed that both groups showed a statistically significant decrease in the CCQ  (p  < 0.05). The multimedia group showed a statistically significant increase in the lower-limb muscle strengthening  (p  < 0.05), while the control group was not found to show a statistically significant increase in the lower-limb muscle strengthening. Therefore, a pulmonary rehabilitation program using multimedia at home can lessen symptoms and improve exercise performance in COPD patients.",2021,"The multimedia group showed a statistically significant increase in the lower-limb muscle strengthening  (p  < 0.05), while the control group was not found to show a statistically significant increase in the lower-limb muscle strengthening.","['Patients with Chronic Obstructive Pulmonary Disease', 'chronic obstructive pulmonary disease (COPD) patients', 'COPD patients', 'twenty COPD patients older than 60 years of age with moderate to severe stages']","['home-based pulmonary rehabilitation by instructive multimedia in the form of videos and flip charts', 'eight-week home-based pulmonary rehabilitation program', 'control group, which was only provided with telephone monitoring', 'Home-Based Multimedia Pulmonary Rehabilitation Program', 'Home-based pulmonary rehabilitation']","['CCQ', 'clinical COPD questionnaire (CCQ), and exercise performance', 'exercise performance', 'lower-limb muscle strengthening', 'clinical symptoms and exercise performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C2919593', 'cui_str': 'Clinical chronic obstructive pulmonary disease questionnaire'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",20.0,0.00692173,"The multimedia group showed a statistically significant increase in the lower-limb muscle strengthening  (p  < 0.05), while the control group was not found to show a statistically significant increase in the lower-limb muscle strengthening.","[{'ForeName': 'Anoma', 'Initials': 'A', 'LastName': 'Santiworakul', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Science, Walailak University, 222 Thasala, Thaiburi, Nakhon Si Thammarat 80160, Thailand.'}, {'ForeName': 'Nitita', 'Initials': 'N', 'LastName': 'Piya-Amornphan', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Science, Walailak University, 222 Thasala, Thaiburi, Nakhon Si Thammarat 80160, Thailand.'}, {'ForeName': 'Netchanok', 'Initials': 'N', 'LastName': 'Jianramas', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Science, Walailak University, 222 Thasala, Thaiburi, Nakhon Si Thammarat 80160, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph182111479']
3155,34769980,The Wildman Programme-Rehabilitation and Reconnection with Nature for Men with Mental or Physical Health Problems-A Matched-Control Study.,"Men with health problems refuse to participate in rehabilitation programmes and drop out of healthcare offerings more often than women. Therefore, a nature-based rehabilitation programme was tailored specific to men with mental health problems, and long-term illnesses. The rehabilitation programme combines the use of nature, body, mind, and community spirit (NBMC) and is called the 'Wildman Programme'. The presented study was designed as a matched-control study with an intervention group participating in the Wildman Programme (N = 114) compared to a control group receiving treatment as usual (N = 39). Outcomes were measured at baseline (T1), post-intervention (T2), and 6 months post-intervention (T3). The primary outcome was the participants' quality of life measured by WHOQOL-BREF, which consists of four domains: physical health, psychological health, social relationships, and environment. The secondary outcomes were the level of stress measured by the Perceived Stress Scale (PSS), and the participants' emotional experience in relation to nature, measured by the Perceived Restorativeness Scale (PRS). The intervention group improved significantly in the physical and psychological WHOQOL-BREF domains and in PSS at both follow-ups. The participants' interest in using nature for restoration increased significantly as well. The only detectable difference between the control group and the intervention group was in the WHOQOL-BREF physical domain at the 6-month follow-up. For further studies, we recommend testing the effect of the Wildman Programme in an RCT study.",2021,The intervention group improved significantly in the physical and psychological WHOQOL-BREF domains and in PSS at both follow-ups.,"['Men with Mental or Physical Health Problems-A Matched-Control Study', 'men with mental health problems, and long-term illnesses', 'Men with health problems refuse to participate in rehabilitation programmes and drop out of healthcare offerings more often than women']","['control group receiving treatment as usual', 'Wildman Programme']","['physical and psychological WHOQOL-BREF domains and in PSS', 'WHOQOL-BREF physical domain', ""level of stress measured by the Perceived Stress Scale (PSS), and the participants' emotional experience in relation to nature, measured by the Perceived Restorativeness Scale (PRS"", ""participants' quality of life measured by WHOQOL-BREF, which consists of four domains: physical health, psychological health, social relationships, and environment""]","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1446390', 'cui_str': 'Physical health problems'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",,0.0150297,The intervention group improved significantly in the physical and psychological WHOQOL-BREF domains and in PSS at both follow-ups.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Høegmark', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5000 Odense, Denmark.'}, {'ForeName': 'Tonny Elmose', 'Initials': 'TE', 'LastName': 'Andersen', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5000 Odense, Denmark.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Grahn', 'Affiliation': 'Department of People and Society, Swedish University of Agricultural Sciences, SE-234 56 Alnarp, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mejldal', 'Affiliation': 'Unit of Clinical Alcohol Research, Institute of Clinical Research, University of Southern Denmark, 5000 Odense, Denmark.'}, {'ForeName': 'Kirsten K', 'Initials': 'KK', 'LastName': 'Roessler', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5000 Odense, Denmark.'}]",International journal of environmental research and public health,['10.3390/ijerph182111465']
3156,34769977,The Use of Cardiac Autonomic Responses to Aerobic Exercise in Elderly Stroke Patients: Functional Rehabilitation as a Public Health Policy.,"BACKGROUND AND PURPOSE


The development of public policies must be guided by full knowledge of the health-disease process of the population. Aerobic exercises are recommended for rehabilitation in stroke patients, and have been shown to improve heart rate variability (HRV). Our aim was to compare the cardiac autonomic modulation of elderly stroke patients with that of healthy elderly people during and after an acute bout of aerobic exercise.
METHODS


A total of 60 elderly people participated in the study (30 in the control group, mean age of 67 ± 4 years; 30 in the stroke group, mean age of 69 ± 3 years). HRV was analyzed in rest-10 min of rest in supine position; exercise-the 30 min of peak exercise; and recovery-30 min in supine position post-exercise.
RESULTS


Taking rest and exercises together, for SDNN, RMSSD, pNN50, RRTri, and TINN, there was no difference between the stroke and control groups ( p  = 0.062;  p  = 0.601;  p  = 0.166;  p  = 0.224, and  p  = 0.059, respectively). The HF (ms 2 ) was higher and the LF/HF ratio was lower for the stroke group than the control group ( p  < 0.001 and  p  = 0.007, respectively). The SD2 was lower for the stroke group than for the control group ( p  = 0.041).
CONCLUSION


Stroke patients present reduced variability at rest, sympathetic predominance during exercise, and do not return to baseline after the 30 min of recovery, with similar responses found in the healthy elderly group.",2021,"The HF (ms 2 ) was higher and the LF/HF ratio was lower for the stroke group than the control group ( p  < 0.001 and  p  = 0.007, respectively).","['60 elderly people participated in the study (30 in the control group, mean age of 67 ± 4 years; 30 in the stroke group, mean age of 69 ± 3 years', 'Elderly Stroke Patients', 'stroke patients', 'elderly stroke patients with that of healthy elderly people during and after an acute bout of aerobic exercise']","['Aerobic Exercise', 'Aerobic exercises']","['SDNN, RMSSD, pNN50, RRTri, and TINN', 'HRV', 'LF/HF ratio', 'heart rate variability (HRV', 'SD2']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",60.0,0.0423995,"The HF (ms 2 ) was higher and the LF/HF ratio was lower for the stroke group than the control group ( p  < 0.001 and  p  = 0.007, respectively).","[{'ForeName': 'Rodrigo Daminello', 'Initials': 'RD', 'LastName': 'Raimundo', 'Affiliation': 'Faculdade de Saúde Pública, Universidade de São Paulo, Av. Dr. Arnaldo, 715-Cerqueira César, Sao Paulo 01246-000, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Zangirolami-Raimundo', 'Affiliation': 'Laboratório de Delineamento de Estudos e Escrita Científica, Centro Universitário FMABC, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo Andre 09060-870, Brazil.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Leone', 'Affiliation': 'Faculdade de Saúde Pública, Universidade de São Paulo, Av. Dr. Arnaldo, 715-Cerqueira César, Sao Paulo 01246-000, Brazil.'}, {'ForeName': 'Tatiana Dias', 'Initials': 'TD', 'LastName': 'de Carvalho', 'Affiliation': 'Departamento de Ciencias de la Salud, Universidad Nacional de La Matanza, Florencio Varela 1903, San Justo B1754, Argentina.'}, {'ForeName': 'Talita Dias', 'Initials': 'TD', 'LastName': 'da Silva', 'Affiliation': 'Departamento de Cardiologia, Universidade Federal de São Paulo, Rua Sena Madureira, 1500-1º Andar-Vila Clementino, Sao Paulo 04021-001, Brazil.'}, {'ForeName': 'Italla Maria Pinheiro', 'Initials': 'IMP', 'LastName': 'Bezerra', 'Affiliation': 'Escola Superior de Ciências da Santa Casa de Misericórdia de Vitória, Avenida Nossa Senhora da Penha, 2190-Bela Vista, Vitoria 29027-502, Brazil.'}, {'ForeName': 'Alvaro Dantas', 'Initials': 'AD', 'LastName': 'de Almeida', 'Affiliation': 'Programa de Pós-Graduação em Ciencias Médicas, Faculdade de Medicina da USP, Universidade de São Paulo, Av. Dr. Arnaldo, 455-Cerqueira César, Pacaembu-SP 01246-903, Brazil.'}, {'ForeName': 'Vitor Engracia', 'Initials': 'VE', 'LastName': 'Valenti', 'Affiliation': 'Centro de Estudos do Sistema Nervoso Autônomo (CESNA), Universidade Estadual Paulista, Av. Hygino Muzzi Filho, 737, Marilia 17525-900, Brazil.'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'de Abreu', 'Affiliation': 'Centro de Estudos do Sistema Nervoso Autônomo (CESNA), Universidade Estadual Paulista, Av. Hygino Muzzi Filho, 737, Marilia 17525-900, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph182111460']
3157,34769975,Effect of Case-Based Small-Group Learning on Care Workers' Emergency Coping Abilities.,"This study aimed to develop and implement an emergency coping education program using a case-based small-group learning method and verify its effect on care workers' emergency coping abilities. The study was conducted with 72 care workers in older adult care facilities and home care centers. Using a nonequivalent control group pretest-posttest design, 36 participants were assigned to each group (i.e., experimental and control groups). The collected data were analyzed through χ ² -test and independent t-test using SPSS for Windows, version 25.0. Compared to the control group, a statistically significant increase in knowledge and performance levels in emergencies, emergency coping abilities, self-efficacy in coping with emergencies, and confidence in communication was observed in the experimental group. This study was able to verify the effectiveness of the emergency coping education program in care workers and recommends its use. To maximize the learning effects of educational programs, future research should develop and apply programs that incorporate simulation education.",2021,"Compared to the control group, a statistically significant increase in knowledge and performance levels in emergencies, emergency coping abilities, self-efficacy in coping with emergencies, and confidence in communication was observed in the experimental group.","[""care workers' emergency coping abilities"", '72 care workers in older adult care facilities and home care centers', ""Care Workers' Emergency Coping Abilities""]","['Case-Based Small-Group Learning', 'emergency coping education program']","['knowledge and performance levels in emergencies, emergency coping abilities, self-efficacy in coping with emergencies, and confidence in communication']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1171208', 'cui_str': 'Older adult care'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",36.0,0.0180864,"Compared to the control group, a statistically significant increase in knowledge and performance levels in emergencies, emergency coping abilities, self-efficacy in coping with emergencies, and confidence in communication was observed in the experimental group.","[{'ForeName': 'Soon-Ok', 'Initials': 'SO', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Shinhan University, Uijeongbu 11340, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph182111458']
3158,34769925,Choline-Based Multi-Ingredient Supplementation Can Improve Explosive Strength during a Fatiguing Task.,"Various choline-based multi-ingredient supplementations (CMS) have been suggested in the current market, but the research is limited. The purpose of this study was to investigate the acute effect of a CMS on physical performance. Fourteen male college football players (20.4 ± 1.0 years) participated in a randomized double-blind crossover experiment separated by 7 days. Subjects were given a CMS or a placebo 60 min before physical performance testing measures, including maximum vertical jumps, maximum voluntary isometric contractions (MVIC), maximal voluntary concentric contractions (MVCC), and fatiguing contractions. Four MVICs and seven sets of two MVCCs at various loads (1 N·m to 60% MVIC torque) were performed with the knee extensor muscles while seated on a dynamometer before and after the fatiguing tasks. During the fatiguing tasks, 120 MVCCs (4 sets × 30 reps) were performed with a load equivalent to 20% MVIC. Twitch interpolation technique was used to assess muscle contractile properties and voluntary activation. No significant differences were seen at baseline between sessions for all testing measures including vertical jump height, strength, power, muscle contractile properties and voluntary activation. Rate of torque development and impulse was higher in supplemental session compared to control session throughout the fatiguing contractions ( p  = 0.018,  p  < 0.001, respectively). Acute CMS can improve explosive strength by delaying the onset of fatigue.",2021,"No significant differences were seen at baseline between sessions for all testing measures including vertical jump height, strength, power, muscle contractile properties and voluntary activation.",['Fourteen male college football players (20.4 ± 1.0 years'],"['Various choline-based multi-ingredient supplementations (CMS', 'CMS', 'CMS or a placebo', 'Choline-Based Multi-Ingredient Supplementation']","['explosive strength', 'muscle contractile properties and voluntary activation', 'Explosive Strength', 'vertical jump height, strength, power, muscle contractile properties and voluntary activation', 'Rate of torque development and impulse', 'physical performance', 'maximum vertical jumps, maximum voluntary isometric contractions (MVIC), maximal voluntary concentric contractions (MVCC), and fatiguing contractions']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",14.0,0.177483,"No significant differences were seen at baseline between sessions for all testing measures including vertical jump height, strength, power, muscle contractile properties and voluntary activation.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Gage', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, Houghton, MI 49931, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Exercise Science Program, Brevard College, Brevard, NC 28712, USA.'}, {'ForeName': 'Byungjoo', 'Initials': 'B', 'LastName': 'Noh', 'Affiliation': 'Department of Kinesiology, Jeju University, Jeju-si 63243, Korea.'}, {'ForeName': 'Tejin', 'Initials': 'T', 'LastName': 'Yoon', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, Houghton, MI 49931, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph182111400']
3159,34769920,"The Association of Recurrent and Multiple Types of Abuse with Adverse Mental Health, Substance Use, and Sexual Health Outcomes among Out-of-School Adolescent Girls and Young Women in Cape Town, South Africa.","Although physical and sexual abuse exposure is a well-established risk for poor health, the dimensions of abuse associated with health among socially vulnerable adolescent girls and young women (AGYW) remain underexamined. This article describes associations between combinations of abuse type and timing with mental health, substance use, and sexual risk outcomes among a sample of 499 AGYW (aged 16 to 19) who had left school early and were recruited for a cluster randomized trial in Cape Town, South Africa. Approximately one-third (33.5%; 95% CI: 28.7, 38.6) of participants reported lifetime abuse. Exposure to more than one type of abuse was associated with increased risk of depression (β = 3.92; 95% CI: 2.25, 5.59) and anxiety (β = 3.70; 95% CI: 2.11, 5.28), and greater odds of polydrug use (OR = 2.10; 95% CI: 1.02, 4.34) and substance-impaired sex (OR = 2.17; 95% CI: 1.31, 3.86). Exposure to multiple types of abuse during childhood/early adolescence and again in late adolescence was associated with increased risk of depression (β = 4.65; 95% CI: 3.15, 6.14), anxiety (β = 4.35; 95% CI: 2.70, 6.02), and polydrug use (OR = 2.37; 95% CI: 1.03, 5.73). Findings underscore the need for trauma-informed interventions that reduce mental health, substance use, and sexual risks among AGYW who have experienced multiple forms of abuse and recurrent abuse.",2021,"Exposure to more than one type of abuse was associated with increased risk of depression (β = 3.92; 95% CI: 2.25, 5.59) and anxiety (β = 3.70; 95% CI: 2.11, 5.28), and greater odds of polydrug use (OR = 2.10; 95% CI: 1.02, 4.34) and substance-impaired sex (OR = 2.17; 95% CI: 1.31, 3.86).","['a sample of 499 AGYW (aged 16 to 19) who had left school early and were recruited for a cluster randomized trial in Cape Town, South Africa', 'Out-of-School Adolescent Girls and Young Women in Cape Town, South Africa']",[],"['anxiety', 'risk of depression', 'lifetime abuse']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}]",,0.180245,"Exposure to more than one type of abuse was associated with increased risk of depression (β = 3.92; 95% CI: 2.25, 5.59) and anxiety (β = 3.70; 95% CI: 2.11, 5.28), and greater odds of polydrug use (OR = 2.10; 95% CI: 1.02, 4.34) and substance-impaired sex (OR = 2.17; 95% CI: 1.31, 3.86).","[{'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Myers', 'Affiliation': 'Curtin enAble Institute, Faculty of Health Sciences, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'Browne', 'Affiliation': 'RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Carney', 'Affiliation': 'Alcohol, Tobacco and Other Drug Abuse Research Unit, South African Medical Research Council, P.O. Box 19070, Tygerberg 7505, South Africa.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Kline', 'Affiliation': 'RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'Courtney Peasant', 'Initials': 'CP', 'LastName': 'Bonner', 'Affiliation': 'RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'Wendee M', 'Initials': 'WM', 'LastName': 'Wechsberg', 'Affiliation': 'RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27709, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph182111403']
3160,34770243,A Preliminary Evaluation of the Unified Protocol among Trauma-Exposed Adults with and without PTSD.,"The purpose of this study was to evaluate whether the Unified Protocol (UP)-a mechanistically transdiagnostic psychological treatment-provides benefit to individuals with a range of trauma histories, psychological difficulties, and diagnostic comorbidity. Using data from a sequential multiple-assignment randomized trial (SMART), this exploratory analysis included a sample of 69 community-recruited adults seeking outpatient mental health treatment. We examined reductions in anxiety and depressive symptoms and changes in aversive and avoidant reactions to intense emotions-the UP's putative mechanism-first by comparing individuals with and without trauma histories and then specifically among participants with PTSD. Findings suggest that the UP may lead to similar improvements in clinical diagnostic severity, anxiety, and depression among patients with trauma exposure as those without trauma exposure. Roughly half of participants with PTSD demonstrated reductions in PTSD clinical severity, anxiety, depression, and distress aversion, suggesting the UP may be an efficacious treatment for people with PTSD and comorbid conditions.",2021,We examined reductions in anxiety and depressive symptoms and changes in aversive and avoidant reactions to intense emotions-the UP's putative mechanism-first by comparing individuals with and without trauma histories and then specifically among participants with PTSD.,"['individuals with a range of trauma histories, psychological difficulties, and diagnostic comorbidity', '69 community-recruited adults seeking outpatient mental health treatment', 'individuals with and without trauma histories and then specifically among participants with PTSD', 'Trauma-Exposed Adults with and without PTSD']",['Unified Protocol (UP)-a mechanistically transdiagnostic psychological treatment'],"['clinical diagnostic severity, anxiety, and depression', 'anxiety and depressive symptoms and changes in aversive and avoidant reactions', 'PTSD clinical severity, anxiety, depression, and distress aversion']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0233496', 'cui_str': 'Aversion'}]",69.0,0.0895101,We examined reductions in anxiety and depressive symptoms and changes in aversive and avoidant reactions to intense emotions-the UP's putative mechanism-first by comparing individuals with and without trauma histories and then specifically among participants with PTSD.,"[{'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY 40506, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Southward', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY 40506, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bugher', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY 40506, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY 40506, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph182111729']
3161,34770233,Assessment of the Strength Parameters of the Quadriceps Femoris Muscles in Polish University Students after a 3-Week Program of Neuromuscular Electrical Stimulation Using the RSQ1 Method.,"A rehabilitative program for patients who lose strength and muscle mass along with the ability to perform intensive exercises is lacking. We developed a 3-week training program based on neuromuscular electrical stimulation (NMES) using a RSQ1 device (modulated current resulting from the overlapping of two-component currents) for RSQ1 electrostimulation to improve strength parameters of the quadricep femoris muscles and compare its effectiveness to isometric training. Nineteen university students were randomly divided into the NMES group (10 sessions) and the control group who trained. We measured the circumference of the thigh, as well as peak torques of the flexor and extensor muscles before and after the start and after the end of the training program. Both tested training programs gave similar results. Differences between measured parameters were not significant except for differences in the peak torques of the knee flexors (9.9% for left limb;  p  = 0.2135 vs. 7.8% for rift limb;  p  = 0.2135) and the circumference of the left thigh-2% for both (left  p  = 0.5839 and right  p  = 0.1088). Comparable results of the tested training programs suggest that NMES is a good alternative for people who cannot perform exercises, but want to maintain or improve their physical fitness.",2021,Differences between measured parameters were not significant except for differences in the peak torques of the knee flexors (9.9% for left limb;  p  = 0.2135 vs. 7.8% for rift limb;  p  = 0.2135) and the circumference of the left thigh-2% for both (left  p  =,"['Nineteen university students', 'Polish University Students after a 3-Week Program of Neuromuscular Electrical Stimulation Using the RSQ1 Method']","['NMES', 'control group who trained', 'training program based on neuromuscular electrical stimulation (NMES) using a RSQ1 device (modulated current resulting from the overlapping of two-component currents) for RSQ1 electrostimulation']","['peak torques of the knee flexors', 'peak torques of the flexor and extensor muscles']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",,0.00115423,Differences between measured parameters were not significant except for differences in the peak torques of the knee flexors (9.9% for left limb;  p  = 0.2135 vs. 7.8% for rift limb;  p  = 0.2135) and the circumference of the left thigh-2% for both (left  p  =,"[{'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Rywacka', 'Affiliation': 'Department of Physiotherapy in Neurology and Pediatrics, Wroclaw University of Health and Sport Sciences, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Stefańska', 'Affiliation': 'Department of Physiotherapy in Dysfunctions of the Locomotor System, Wroclaw University of Health and Sport Sciences, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Dziuba-Słonina', 'Affiliation': 'Department of Physiotherapy in Neurology and Pediatrics, Wroclaw University of Health and Sport Sciences, 51-612 Wroclaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph182111717']
3162,34770611,Effects of Concurrent and Terminal Visual Feedback on Ankle Co-Contraction in Older Adults during Standing Balance.,"This preliminary investigation studied the effects of concurrent and terminal visual feedback during a standing balance task on ankle co-contraction, which was accomplished via surface electromyography of an agonist-antagonist muscle pair (medial gastrocnemius and tibialis anterior muscles). Two complementary mathematical definitions of co-contraction indices captured changes in ankle muscle recruitment and modulation strategies. Nineteen healthy older adults received both feedback types in a randomized order. Following an analysis of co-contraction index reliability as a function of surface electromyography normalization technique, linear mixed-effects regression analyses revealed participants learned or utilized different ankle co-contraction recruitment (i.e., relative muscle pair activity magnitudes) and modulation (i.e., absolute muscle pair activity magnitudes) strategies depending on feedback type and following the cessation of feedback use. Ankle co-contraction modulation increased when concurrent feedback was used and significantly decreased when concurrent feedback was removed. Ankle co-contraction recruitment and modulation did not significantly change when terminal feedback was used or when it was removed. Neither ankle co-contraction recruitment nor modulation was significantly different when concurrent feedback was used compared to when terminal feedback was used. The changes in ankle co-contraction recruitment and modulation were significantly different when concurrent feedback was removed as compared to when terminal feedback was removed. Finally, this study found a significant interaction between feedback type, removal of feedback, and order of use of feedback type. These results have implications for the design of balance training technologies using visual feedback.",2021,Neither ankle co-contraction recruitment nor modulation was significantly different when concurrent feedback was used compared to when terminal feedback was used.,"['Nineteen healthy older adults', 'Older Adults during Standing Balance']","['concurrent and terminal visual feedback', 'Concurrent and Terminal Visual Feedback']","['Ankle co-contraction modulation', 'feedback type, removal of feedback, and order of use of feedback type']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]",19.0,0.0174863,Neither ankle co-contraction recruitment nor modulation was significantly different when concurrent feedback was used compared to when terminal feedback was used.,"[{'ForeName': 'Rachel V', 'Initials': 'RV', 'LastName': 'Vitali', 'Affiliation': 'Department of Mechanical Engineering, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Barone', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Ferris', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Leia A', 'Initials': 'LA', 'LastName': 'Stirling', 'Affiliation': 'Department of Industrial and Operations Engineering, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Kathleen H', 'Initials': 'KH', 'LastName': 'Sienko', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, MI 48109, USA.'}]","Sensors (Basel, Switzerland)",['10.3390/s21217305']
3163,34771651,In Vivo Reflectance Confocal Microscopy as a Response Monitoring Tool for Actinic Keratoses Undergoing Cryotherapy and Photodynamic Therapy.,"Reflectance confocal microscopy (RCM) presents a non-invasive method to image actinic keratosis (AK) at a cellular level. However, RCM criteria for AK response monitoring vary across studies and a universal, standardized approach is lacking. We aimed to identify reliable AK response criteria and to compare the clinical and RCM evaluation of responses across AK severity grades. Twenty patients were included and randomized to receive either cryotherapy ( n  = 10) or PDT ( n  = 10). Clinical assessment and RCM evaluation of 12 criteria were performed in AK lesions and photodamaged skin at baseline, 3 and 6 months. We identified the RCM criteria that reliably characterize AK at baseline and display significant reduction following treatment. Those with the highest baseline odds ratio (OR), good interobserver agreement, and most significant change over time were atypical honeycomb pattern (OR: 12.7, CI: 5.7-28.1), hyperkeratosis (OR: 13.6, CI: 5.3-34.9), stratum corneum disruption (OR: 7.8, CI: 3.5-17.3), and disarranged epidermal pattern (OR: 6.5, CI: 2.9-14.8). Clinical evaluation demonstrated a significant treatment response without relapse. However, in grade 2 AK, 10/12 RCM parameters increased from 3 to 6 months, which suggested early subclinical recurrence detection by RCM. Incorporating standardized RCM protocols for the assessment of AK may enable a more meaningful comparison across clinical trials, while allowing for the early detection of relapses and evaluation of biological responses to therapy over time.",2021,Twenty patients were included and randomized to receive either cryotherapy ( n  = 10) or PDT ( n  = 10).,"['Twenty patients', 'Actinic Keratoses Undergoing Cryotherapy and Photodynamic Therapy']","['Reflectance confocal microscopy (RCM', 'cryotherapy', 'PDT']",['stratum corneum disruption'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",20.0,0.0453153,Twenty patients were included and randomized to receive either cryotherapy ( n  = 10) or PDT ( n  = 10).,"[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Curiel-Lewandrowski', 'Affiliation': 'Division of Dermatology, The University of Arizona College of Medicine, Tucson, AZ 85724, USA.'}, {'ForeName': 'Caitlyn N', 'Initials': 'CN', 'LastName': 'Myrdal', 'Affiliation': 'Division of Dermatology, The University of Arizona College of Medicine, Tucson, AZ 85724, USA.'}, {'ForeName': 'Kathylynn', 'Initials': 'K', 'LastName': 'Saboda', 'Affiliation': 'The University of Arizona Cancer Center, Tucson, AZ 85724, USA.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Zuckerman College of Public Health, The University of Arizona, Tucson, AZ 85721, USA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Arzberger', 'Affiliation': 'Department of Dermatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pellacani', 'Affiliation': 'Dermatology, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, La Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Franz Josef', 'Initials': 'FJ', 'LastName': 'Legat', 'Affiliation': 'Department of Dermatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Ulrich', 'Affiliation': 'CMB Collegium Medicum Berlin GmbH/Dermatology Office, 10117 Berlin, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Hochfellner', 'Affiliation': 'Department of Dermatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Oliviero', 'Affiliation': 'Skin and Cancer Associates, Fort Lauderdale, FL 33324, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Pasquali', 'Affiliation': 'Pius Hospital of Valls, 43850 Tarragona, Spain.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gill', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Alcalá de Henares, 28801 Madrid, Spain.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hofmann-Wellenhof', 'Affiliation': 'Department of Dermatology, Medical University of Graz, 8036 Graz, Austria.'}]",Cancers,['10.3390/cancers13215488']
3164,34771712,Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study.,"Immune-related adverse events (irAEs) are very prevalent when treating patients with ipilimumab and nivolumab in combination, and 30-40% of patients discontinue the treatment for this reason. It is of high clinical relevance to investigate the consequences of discontinuing the treatment early since combination therapy with ipilimumab and nivolumab is the first line of treatment for many patients with metastatic melanoma. In this follow-up study, with real-world data from the nationwide DAMMED database, we investigated whether there was a difference in progression-free survival (PFS) and overall survival (OS) for patients who discontinued or did not discontinue treatment within the first four doses of treatment due to irAEs. In total, 448 patients were treated with ipilimumab and nivolumab. Of these, 133 patients discontinued due to irAEs in the induction phase. Using the Cox proportional hazards model, there was no significant difference in PFS when comparing the group that discontinued with the group that did not discontinue. The group that discontinued had a significantly longer OS than the group that received the full length of treatment. Therefore, we conclude that there is no significant negative impact on efficacy for patients who discontinue due to irAEs in the induction phase of combination immunotherapy for metastatic melanoma.",2021,The group that discontinued had a significantly longer OS than the group that received the full length of treatment.,"['Patients with Metastatic Melanoma Treated with', 'many patients with metastatic melanoma', '133 patients discontinued due to irAEs in the induction phase', '448 patients were treated with']","['Ipilimumab and Nivolumab', 'ipilimumab and nivolumab']","['Immune-Related Adverse Events', 'PFS', 'progression-free survival (PFS) and overall survival (OS', 'longer OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",448.0,0.0647524,The group that discontinued had a significantly longer OS than the group that received the full length of treatment.,"[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Fink', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, 8200 Aarhus, Denmark.'}, {'ForeName': 'Anders Schwartz', 'Initials': 'AS', 'LastName': 'Vittrup', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, 8200 Aarhus, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Department of Oncology, Odense University Hospital, 5000 Odense, Denmark.'}, {'ForeName': 'Inge Marie', 'Initials': 'IM', 'LastName': 'Svane', 'Affiliation': 'National Center for Cancer Immuno Therapy, CCIT-DK, Department of Oncology, Copenhagen University Hospital, 2730 Herlev, Denmark.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Donia', 'Affiliation': 'National Center for Cancer Immuno Therapy, CCIT-DK, Department of Oncology, Copenhagen University Hospital, 2730 Herlev, Denmark.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Luczak', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, 9100 Aalborg, Denmark.'}, {'ForeName': 'Christina H', 'Initials': 'CH', 'LastName': 'Ruhlmann', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, 5230 Odense, Denmark.'}, {'ForeName': 'Louise Mahncke', 'Initials': 'LM', 'LastName': 'Guldbrandt', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, 8200 Aarhus, Denmark.'}, {'ForeName': 'Ulrich Heide', 'Initials': 'UH', 'LastName': 'Koehler', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, 8200 Aarhus, Denmark.'}, {'ForeName': 'Mette Lerche', 'Initials': 'ML', 'LastName': 'Winther', 'Affiliation': 'Department of Oncology, Odense University Hospital, 5000 Odense, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ellebaek', 'Affiliation': 'National Center for Cancer Immuno Therapy, CCIT-DK, Department of Oncology, Copenhagen University Hospital, 2730 Herlev, Denmark.'}, {'ForeName': 'Charlotte Aaquist', 'Initials': 'CA', 'LastName': 'Haslund', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, 9100 Aalborg, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, 8200 Aarhus, Denmark.'}]",Cancers,['10.3390/cancers13215550']
3165,34772399,Evaluation of topical erythropoietin application on the healing outcome of gingival graft recipient site; a randomized controlled clinical trial.,"BACKGROUND


Free gingival graft (FGG) is a highly predictable method to increase the width of keratinized gingiva. Various materials have been reported to accelerate the wound healing process. Considering the positive effect of EPO on dermal wound healing this study aimed to investigate the effects of EPO on the rate of healing and degree of inflammation in free gingival grafts.
METHODS


Seventeen patients with bilateral lack of keratinized gingiva in mandible were selected for this clinical trial. The surgical intervention was performed after phase I periodontal therapy. Recipient site was prepared apical to the mucogingival line, and FGG was harvested from the palate. Before graft placement, the test side and control side were treated with 1 ml of EPO 4000 IU/ml and distilled water, respectively, for 2 min. On days 7, 14, 21, 28, 60, and 90 after surgery, the grafted sites were examined by blinded observers to compare the healing and inflammation of the areas.
RESULTS


All the 17 patients completed the surgeries and follow-up examinations. Direct examination revealed significantly better healing in EPO group only on the 28th day. Assessment of the photographs showed a significant value in favor of the test group at some other time points as well. The EPO group demonstrated less inflammation, which was statistically significant in many time points. The graft area was 80.88 ± 30.21 mm 2  and 71.35 ± 15.62 mm 2  in the EPO and control groups, respectively. The difference was not significant, though.
CONCLUSIONS


Topical application of erythropoietin can accelerate the healing of gingival grafts and reduce the inflammation during healing period. The final graft outcome, nevertheless, does not seem to be influenced by EPO. Trial registration This was a split-mouth randomized controlled clinical trial (IRCT201201278830N1). The first registration date: 2016-10-22.",2021,"The graft area was 80.88 ± 30.21 mm 2  and 71.35 ± 15.62 mm 2  in the EPO and control groups, respectively.","['gingival graft recipient site', 'Seventeen patients with bilateral lack of keratinized gingiva in mandible', '17 patients completed the surgeries and follow-up examinations']","['EPO', 'topical erythropoietin application', 'erythropoietin']","['healing', 'rate of healing and degree of inflammation', 'healing of gingival grafts', 'healing outcome', 'healing and inflammation of the areas']","[{'cui': 'C1868699', 'cui_str': 'Gingival graft'}, {'cui': 'C1455688', 'cui_str': 'Recipient site'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3873496', 'cui_str': 'Lack of keratinized gingiva'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1868699', 'cui_str': 'Gingival graft'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",17.0,0.0684972,"The graft area was 80.88 ± 30.21 mm 2  and 71.35 ± 15.62 mm 2  in the EPO and control groups, respectively.","[{'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Yaghobee', 'Affiliation': 'Periodontics Department, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rouzmeh', 'Affiliation': 'Periodontics Department, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. ninarouzmeh@yahoo.com.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Periodontics Department, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hoori', 'Initials': 'H', 'LastName': 'Aslroosta', 'Affiliation': 'Periodontics Department, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Mahmoodi', 'Affiliation': 'Independent Researcher, Novin Formula Consulting Group, Tehran, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Mohammadnejad Hardoroodi', 'Affiliation': 'Private Office, Qaemshahr, Iran.'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Soleimanzadeh Azar', 'Affiliation': 'Endodontic Department, UTHSCSA, San Antonio, Texas, United States.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Khorsand', 'Affiliation': 'Periodontics Department, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}]",BMC oral health,['10.1186/s12903-021-01948-8']
3166,34772395,"Two-year outcomes of surgeon-tailored trans obturator tape for female stress urinary incontinence: a randomized, comparative, trial with traditional trans obturator tape.","BACKGROUND


Previously, we presented the short-term outcomes of surgeon-tailored mesh in patients with SUI undergoing TOT. In this report, we aim to highlight the two-year outcomes of surgeon tailored mesh in terms of subjective and objective cure rates, as well as late complications.
METHODS


We performed a randomized, open-label comparative trial that recruited women with SUI who were scheduled to undergo TOT. Eligible patients were randomly allocated in a 1:1 ratio to receive traditional TOT mesh or surgeon-tailored polyethylene mesh. All patients were followed up for two years.
RESULTS


At the end of the follow-up, there were 13 women in the traditional TOT mesh group and 14 patients in the surgeon-tailored polyethylene mesh group. Concerning the primary outcome of the present study, the cure rate was 100% in the surgeon-tailored polyethylene mesh (n = 14) and 92.9% in the traditional TOT mesh group (p = 0.39). One woman reported improved symptoms in the traditional TOT mesh group. There were no reported failures in both groups. Concerning safety, the incidence of de novo urgency was 0% in the surgeon-tailored polyethylene mesh group, compared to 7.1% in the traditional TOT mesh group (p = 0.34). None of the women in both groups reported mesh erosions, dyspareunia, or need for reoperation.
CONCLUSION


Surgeon-tailored mesh for patients undergoing TOT is a cost-effective technique, which has comparable long-term outcomes, in terms of cure rate and complications, to the traditional costly meshes. Larger multicentre studies should confirm our results.",2021,"Concerning safety, the incidence of de novo urgency was 0% in the surgeon-tailored polyethylene mesh group, compared to 7.1% in the traditional TOT mesh group (p = 0.34).","['patients with SUI undergoing TOT', 'Eligible patients', 'female stress urinary incontinence', 'recruited women with SUI who were scheduled to undergo TOT']","['surgeon-tailored trans obturator tape', 'surgeon tailored mesh', 'traditional trans obturator tape', 'traditional TOT mesh or surgeon-tailored polyethylene mesh']","['incidence of de novo urgency', 'subjective and objective cure rates', 'cure rate', 'mesh erosions, dyspareunia, or need for reoperation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0182021', 'cui_str': 'Obturator'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",,0.167889,"Concerning safety, the incidence of de novo urgency was 0% in the surgeon-tailored polyethylene mesh group, compared to 7.1% in the traditional TOT mesh group (p = 0.34).","[{'ForeName': 'Salah E', 'Initials': 'SE', 'LastName': 'Shebl', 'Affiliation': 'Urology Department, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt. Salahshebl@yahoo.com.'}]",BMC urology,['10.1186/s12894-021-00922-4']
3167,34772301,Coolsense®  versus  EMLA® for peripheral venous cannulation in adult volunteers: A randomised crossover trial.,"Peripheral venous cannulation (PVC) is a commonly performed invasive medical procedure. Topical treatments such as the eutectic mixture of local anaesthetics (EMLA®, Aspen Pharmacare Australia Pty Ltd, St Leonards, NSW) attenuate the associated pain, but are limited by requiring up to one hour of application before becoming effective. The Coolsense® (Coolsense Medical Ltd., Tel Aviv, Israel) pain numbing applicator is a new device using a cryoanalgesic means to anaesthetise skin within seconds. Coolsense is being increasingly used for cannulation, but comparative studies are lacking. We recruited 64 healthy adult volunteers to this open-label two sequence, two period randomised crossover trial. Participants had two 20 gauge venous cannulae inserted, one on the dorsum of each hand. Each cannulation attempt was preceded by treatment with Coolsense or an EMLA patch containing 2.5% lidocaine and 2.5% prilocaine. The primary outcome was participant pain using the 0-10 numerical pain rating scale. Secondary outcomes were participant satisfaction scores on a 0-10 scale, treatment preference, and failed cannulation attempts. Participants were randomly assigned to either the Coolsense EMLA ( n  = 32) or EMLA Coolsense ( n  = 32) sequence. All participants completed the trial. The pooled mean paired difference of the numerical pain rating scale was -1.84 (95% confidence intervals -1.28 to -2.41;  P  < 0.001) in favour of EMLA. The pooled mean paired difference for satisfaction score was 2.26 (95% confidence intervals 1.46 to 3.07;  P  < 0.001) higher with EMLA. Most participants preferred EMLA over Coolsense ( P  < 0.001). There was no significant difference regarding failed cannulation between the two treatments ( P  = 0.14). Among healthy individuals undergoing elective PVC, EMLA was associated with reduced pain, increased satisfaction, and was the preferred treatment compared to Coolsense.",2021,The pooled mean paired difference of the numerical pain rating scale was -1.84,"['Participants had two 20 gauge venous cannulae inserted, one on the dorsum of each hand', '64 healthy adult volunteers to this open-label two sequence', 'adult volunteers', 'healthy individuals undergoing']","['Coolsense or an EMLA patch containing 2.5% lidocaine and 2.5% prilocaine', 'Coolsense EMLA', 'elective PVC, EMLA', 'Coolsense®  versus  EMLA®', 'Peripheral venous cannulation (PVC', 'EMLA Coolsense']","['participant satisfaction scores on a 0-10 scale, treatment preference, and failed cannulation attempts', 'satisfaction score', 'numerical pain rating scale', 'participant pain using the 0-10 numerical pain rating scale', 'reduced pain, increased satisfaction', 'failed cannulation']","[{'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0179583', 'cui_str': 'Venous cannula'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",64.0,0.199376,The pooled mean paired difference of the numerical pain rating scale was -1.84,"[{'ForeName': 'Dilraj', 'Initials': 'D', 'LastName': 'Thind', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Royal Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Roberts', 'Affiliation': 'Department of Anaesthesia, 67587Christchurch Hospital, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Benjamin Fh', 'Initials': 'BF', 'LastName': 'van der Griend', 'Affiliation': 'Department of Anaesthesia, 67587Christchurch Hospital, Christchurch Hospital, Christchurch, New Zealand.'}]",Anaesthesia and intensive care,['10.1177/0310057X211039227']
3168,34772647,No influence of spironolactone on plasma concentrations of angiotensin-converting enzyme 2: Findings from the HOMAGE randomized trial.,,2021,,[],['spironolactone'],['plasma concentrations'],[],"[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0521123,,"[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), centre d'investigations cliniques-plurithématique 1433, Nancy, France; Unidade de Investigaçao Cardiovascular-UnIC, Faculdade de Medicina Universidade do Porto, Porto, Portugal. Electronic address: j.ferreira@chru-nancy.fr.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girerd', 'Affiliation': ""Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), centre d'investigations cliniques-plurithématique 1433, Nancy, France.""}, {'ForeName': 'Hans-Peter Brunner-La', 'Initials': 'HB', 'LastName': 'Rocca', 'Affiliation': 'Department of Cardiology, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Pellicori', 'Affiliation': 'Clinical Trials Unit, Robertson Institute of Biostatistics, University of Glasgow, University Avenue, Glasgow, UK.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Cleland', 'Affiliation': 'Clinical Trials Unit, Robertson Institute of Biostatistics, University of Glasgow, University Avenue, Glasgow, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), centre d'investigations cliniques-plurithématique 1433, Nancy, France.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), centre d'investigations cliniques-plurithématique 1433, Nancy, France.""}]",Archives of cardiovascular diseases,['10.1016/j.acvd.2021.10.003']
3169,34772616,An isometric neck strengthening program does not improve neck strength in elite women's football-code athletes: A randomised controlled trial.,"OBJECTIVES


The purpose of this study was to investigate the effectiveness of an isometric neck strengthening program to improve isometric neck strength in elite women's football-code athletes.
DESIGN


Randomised controlled trial.
METHODS


Elite female soccer (n = 10) and Australian football (n = 30) players were randomised into either a control (n = 20) or experimental (n = 20) group for a 12-week intervention study during their respective seasons. While both groups undertook their prescribed strength and conditioning programs, the experimental group also performed isometric neck strengthening exercises three times per week prior to training. Isometric neck strength of the extensors, flexors, lateral flexors, and rotators were assessed pre, mid (Week 7), and post (Week 13) intervention with a hand-held dynamometer during early to mid-competition season. A mixed design analysis of variance was performed for statistical analysis.
RESULTS


No significant group-by-time interactions in isometric neck strength were observed. All strength variables displayed a significant change over time throughout the 12-week period (p < 0.05). No significant between group differences in isometric neck strength variables were observed except for lateral left flexion (F(1, 38) =5.064, p = 0.030, η 2 p  = 0.117).
CONCLUSIONS


The addition of isometric neck strengthening exercises did not improve neck strength beyond a standard strength and conditioning program for elite women's football-code athletes. While this specific program may not improve neck strength in elite women's football-code athletes, further investigation is needed to determine whether sport-specific neck strength exercises may improve neck strength or if lower-level competition athletes may still benefit from an isometric neck strengthening program.",2021,"No significant between group differences in isometric neck strength variables were observed except for lateral left flexion (F(1, 38) =","[""elite women's football-code athletes"", 'Elite female soccer (n\u202f=\u202f10) and Australian football (n\u202f=\u202f30) players']","['isometric neck strengthening program', 'isometric neck strengthening exercises']","['neck strength', 'Isometric neck strength of the extensors, flexors, lateral flexors, and rotators', 'isometric neck strength variables', 'isometric neck strength']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0126195,"No significant between group differences in isometric neck strength variables were observed except for lateral left flexion (F(1, 38) =","[{'ForeName': 'Candy L', 'Initials': 'CL', 'LastName': 'Deng', 'Affiliation': 'Sport and Exercise Science, School of Allied Health, Human Services and Sport, La Trobe University, Australia.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Pearce', 'Affiliation': 'Sport and Exercise Science, School of Allied Health, Human Services and Sport, La Trobe University, Australia.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Mentiplay', 'Affiliation': 'Sport and Exercise Science, School of Allied Health, Human Services and Sport, La Trobe University, Australia.'}, {'ForeName': 'Kane J', 'Initials': 'KJ', 'LastName': 'Middleton', 'Affiliation': 'Sport and Exercise Science, School of Allied Health, Human Services and Sport, La Trobe University, Australia.'}, {'ForeName': 'Anthea C', 'Initials': 'AC', 'LastName': 'Clarke', 'Affiliation': 'Sport and Exercise Science, School of Allied Health, Human Services and Sport, La Trobe University, Australia. Electronic address: A.Clarke@latrobe.edu.au.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2021.10.009']
3170,34772609,The CIRCULATE Trial: Circulating Tumor DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation (AIO-KRK-0217).,"BACKGROUND


Guidance regarding adjuvant treatment decisions in stage II colorectal cancer (CRC) remains uncertain due to lack of predictive clinical or molecular markers. Recently, postoperative circulating tumour (ct)DNA has been demonstrated to be a strong prognostic marker in early colon cancer.
PATIENTS AND METHODS


CIRCULATE enrols patients with stage II microsatellite stable CRC in Germany (AIO) and Austria (ABCSG). Within the AIO, screening is supported by ColoPredict Plus 2.0, a molecular registry, and screening platform for interventional trials. Patient-specific mutations are centrally analysed by next generation sequencing in the resected primary tumour. A postoperative plasma sample is subsequently screened for the specific mutation(s). ctDNA positive (ctDNApos) patients are randomised (2:1) chemotherapy (capecitabine, oxaliplatin added an investigator's choice) or to follow-up (control group). ctDNA negative (ctDNAneg) patients are randomised (1:4) to be followed-up within CIRCULATE (control group) or outside the trial. Patients in the control group remain blinded to the ctDNA results. The primary objective is to compare disease free survival (DFS) of ctDNApos patients with chemotherapy or control. To demonstrate a treatment effect with a hazard ratio of 0.617 (3-year DFS rates 42.5% vs. 25%), 231 ctDNApos and estimated 2079 ctDNAneg patients are randomised. Secondary aims include to compare overall survival and DFS in the ctDNApos and ctDNAneg patient cohorts and ctDNA kinetics.
CONCLUSION


The CIRCULATE trial may establish ctDNA for adjuvant treatment decision in stage II colon cancer - and with the secondary objectives - support a ctDNA guided follow up in colon cancer stage II and beyond.",2021,"To demonstrate a treatment effect with a hazard ratio of 0.617 (3-year DFS rates 42.5% vs. 25%), 231 ctDNApos and estimated 2079 ctDNAneg patients are randomised.","['Colon Cancer Stage II Evaluation', 'CIRCULATE enrols patients with stage II microsatellite stable CRC in Germany (AIO) and Austria (ABCSG', 'stage II colorectal cancer (CRC', 'ctDNApos patients with chemotherapy or control']","['chemotherapy (capecitabine, oxaliplatin']","['disease free survival (DFS', 'overall survival and DFS']","[{'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C1519302', 'cui_str': 'Short Tandem Repeats'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",2079.0,0.304129,"To demonstrate a treatment effect with a hazard ratio of 0.617 (3-year DFS rates 42.5% vs. 25%), 231 ctDNApos and estimated 2079 ctDNAneg patients are randomised.","[{'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Folprecht', 'Affiliation': 'University Hospital Carl Gustav Carus, Medical Department I, National Centre for Tumor Diseases / University Cancer Centre, Dresden, Germany; German Cancer Consortium (DKTK), Germany. Electronic address: gunnar.folprecht@uniklinikum-dresden.de.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Reinacher-Schick', 'Affiliation': 'Ruhr- University Bochum / St. Josef-Hospital, Bochum, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'University Hospital Carl Gustav Carus, Department for Visceral-, Thoracic- and Vascular Surgery, National Centre for Tumor Diseases / University Cancer Centre, Dresden, Germany; German Cancer Consortium (DKTK), Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Lugnier', 'Affiliation': 'Ruhr- University Bochum / St. Josef-Hospital, Bochum, Germany.'}, {'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Kraeft', 'Affiliation': 'Ruhr- University Bochum / St. Josef-Hospital, Bochum, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wisser', 'Affiliation': 'Ruhr- University Bochum, Institute of Pathology, Bochum, Germany.'}, {'ForeName': 'Daniela E', 'Initials': 'DE', 'LastName': 'Aust', 'Affiliation': 'German Cancer Consortium (DKTK), Germany; University Hospital Carl Gustav Carus, Institut for Pathology, Dresden, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Weiss', 'Affiliation': 'Paracelsus Medical University, IIIrd Medical Department, Salzburg, Austria.'}, {'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'von Bubnoff', 'Affiliation': 'University Hospital Schleswig-Holstein, Clinic for Hematology and Oncology, 23538, Lübeck.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'Technische Universität Dresden, Faculty of Medicine Carl Gustav Carus, Medical Department I, Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'University Hospital Carl Gustav Carus, Medical Department I, Laboratory for Molecular Diagnostics, Dresden, Germany; German Cancer Consortium (DKTK), Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tannapfel', 'Affiliation': 'Ruhr- University Bochum, Institute of Pathology, Bochum, Germany.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2021.09.005']
3171,34772594,Dysphonia Interference in Schoolteachers' Speech Intelligibility in the Classroom.,"""Among the most common occupations, schooteachers are the ones who experience the most changes throughout their career. Considering this, the present study aims to verify whether dysphonia in three different degrees may compromise the speech intelligibility of schoolteachers in the classroom.
METHOD


Overall, 39 students, average age 10 years, randomly selected from a public school in the Federal District, Brazil (Distrito Federal, Brasil) performed a transcription task of 20 sentences spoken by four distinct female voices in a classroom, one with a control voice (normal), another with mild dysphonia, 1 with moderate dysphonia and another with severe dysphonia. None of the voices in the study presented changes, neither in fluency nor articulation nor neurological changes. The sentences were previously recorded in an acoustically treated booth, with a microphone on a pedestal 5 cm away from the speaker's mouth. For each sentence to be recorded, the speech model was provided by the speech therapist and then repeated by the speaker according to the model. Each voice recorded 5 different sentences, phonetically balanced and with equivalent number of words. The students included in the study underwent auditory, auditory processing, sequential memory for verbal sounds and sound source location tests, fulfilling the normality criteria. They also did not have neurological or motor disorders or learning, speech or language disorders. Academic success was also taken into account. For the experiment, a speaker was placed in front of the classroom, 1 m from the wall and 1 m from the floor, and students were randomly assigned to the classroom seats. After listening to each sentence, some time was assigned for its transcription by each student.
RESULTS


The occurrence of errors was higher in voices with moderate and severe dysphonia, in which a significant difference was found (P ≤0.003) showing that voices with moderate and severe dysphonia were less intelligible than the normal voice (control voice). No difference was found between the normal voice and the mild dysphonic voice. Binary logistic regression analysis also showed that students had a 2.55 times higher chance of making mistakes with moderate dysphonic voice (P ≤0.011), and that this chance was 3.06 times greater for severe dysphonic voice (P ≤0.002) when compared to the normal voice (control voice).
CONCLUSION


Moderate and severe dysphonia in the voices of schoolteachers interferes with the intelligibility of students, and the greater the degree of dysphonia of the teacher, the greater the chance that the student will make intelligibility errors.""",2021,"Binary logistic regression analysis also showed that students had a 2.55 times higher chance of making mistakes with moderate dysphonic voice (P ≤0.011), and that this chance was 3.06 times greater for severe dysphonic voice (P ≤0.002) when compared to the normal voice (control voice).
","['39 students, average age 10 years, randomly selected from a public school in the Federal District, Brazil (Distrito Federal, Brasil) performed a']","['transcription task of 20 sentences spoken by four distinct female voices in a classroom, one with a control voice (normal), another with mild dysphonia, 1 with moderate dysphonia and another with severe dysphonia']","['normal voice and the mild dysphonic voice', 'severe dysphonic voice', 'neurological or motor disorders or learning, speech or language disorders', 'Academic success', 'fluency nor articulation nor neurological changes', 'moderate dysphonic voice']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0234759', 'cui_str': 'Normal voice'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0221163', 'cui_str': 'Motor Disorders'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023015', 'cui_str': 'Disorder of language'}, {'cui': 'C0700132', 'cui_str': 'Academic Achievement'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0240637,"Binary logistic regression analysis also showed that students had a 2.55 times higher chance of making mistakes with moderate dysphonic voice (P ≤0.011), and that this chance was 3.06 times greater for severe dysphonic voice (P ≤0.002) when compared to the normal voice (control voice).
","[{'ForeName': 'Glauce Mara Gomes Ferreira', 'Initials': 'GMGF', 'LastName': 'Oliveira', 'Affiliation': 'Secretaria de Estado de Educação do Distrito Federal. Electronic address: glaucemgf@gmail.com.'}, {'ForeName': 'Dayane Cardoso', 'Initials': 'DC', 'LastName': 'de Melo', 'Affiliation': 'Secretaria de Estado de Educação do Distrito Federal. Electronic address: dayanec.demelo@gmail.com.'}, {'ForeName': 'Lucieny Silva Martins', 'Initials': 'LSM', 'LastName': 'Serra', 'Affiliation': 'Universidade de Brasília, Brasília, DF, Brazil. Electronic address: lucienymserra@gmail.com.'}, {'ForeName': 'Ronaldo Campos', 'Initials': 'RC', 'LastName': 'Granjeiro', 'Affiliation': 'Escola Superior de Ciências da Saúde. Electronic address: ronaldogranjeiro@gmail.com.'}, {'ForeName': 'André Luiz Lopes', 'Initials': 'ALL', 'LastName': 'Sampaio', 'Affiliation': 'Universidade de Brasília, Brasília, DF, Brazil. Electronic address: andremarjysampaio@gmail.com.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2021.09.004']
3172,34767705,Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation.,"BACKGROUND


Tricuspid regurgitation is common in patients with severe degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform tricuspid-valve repair during mitral-valve surgery in patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation.
METHODS


We randomly assigned 401 patients who were undergoing mitral-valve surgery for degenerative mitral regurgitation to receive a procedure with or without tricuspid annuloplasty (TA). The primary 2-year end point was a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death.
RESULTS


Patients who underwent mitral-valve surgery plus TA had fewer primary-end-point events than those who underwent mitral-valve surgery alone (3.9% vs. 10.2%) (relative risk, 0.37; 95% confidence interval [CI], 0.16 to 0.86; P = 0.02). Two-year mortality was 3.2% in the surgery-plus-TA group and 4.5% in the surgery-alone group (relative risk, 0.69; 95% CI, 0.25 to 1.88). The 2-year prevalence of progression of tricuspid regurgitation was lower in the surgery-plus-TA group than in the surgery-alone group (0.6% vs. 6.1%; relative risk, 0.09; 95% CI, 0.01 to 0.69). The frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life were similar in the two groups at 2 years, although the incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1% vs. 2.5%; rate ratio, 5.75; 95% CI, 2.27 to 14.60).
CONCLUSIONS


Among patients undergoing mitral-valve surgery, those who also received TA had a lower incidence of a primary-end-point event than those who underwent mitral-valve surgery alone at 2 years, a reduction that was driven by less frequent progression to severe tricuspid regurgitation. Tricuspid repair resulted in more frequent permanent pacemaker implantation. Whether reduced progression of tricuspid regurgitation results in long-term clinical benefit can be determined only with longer follow-up. (Funded by the National Heart, Lung, and Blood Institute and the German Center for Cardiovascular Research; ClinicalTrials.gov number, NCT02675244.).",2021,"The frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life were similar in the two groups at 2 years, although the incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1% vs. 2.5%; rate ratio, 5.75; 95% CI, 2.27 to 14.60).
","['401 patients who were undergoing', 'patients undergoing mitral-valve surgery', 'patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation', 'patients with severe degenerative mitral regurgitation', 'Patients with Degenerative Mitral Regurgitation']","['TA', 'mitral-valve surgery for degenerative mitral regurgitation to receive a procedure with or without tricuspid annuloplasty (TA']","['year mortality', 'composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death', '2-year prevalence of progression of tricuspid regurgitation', 'frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life', 'incidence of permanent pacemaker implantation', 'frequent permanent pacemaker implantation', 'frequent progression to severe tricuspid regurgitation', 'primary-end-point events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}]","[{'cui': 'C0443327', 'cui_str': 'Tricuspid'}, {'cui': 'C0190165', 'cui_str': 'Annuloplasty'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}]",401.0,0.28399,"The frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life were similar in the two groups at 2 years, although the incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1% vs. 2.5%; rate ratio, 5.75; 95% CI, 2.27 to 14.60).
","[{'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Gammie', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Michael W A', 'Initials': 'MWA', 'LastName': 'Chu', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Falk', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overbey', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Moskowitz', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Gillinov', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Voisine', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Krane', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Babatunde', 'Initials': 'B', 'LastName': 'Yerokun', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Bowdish', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Lenard', 'Initials': 'L', 'LastName': 'Conradi', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Bolling', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Marissa A', 'Initials': 'MA', 'LastName': 'Miller', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Taddei-Peters', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Neal O', 'Initials': 'NO', 'LastName': 'Jeffries', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Parides', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Weisel', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Mariell', 'Initials': 'M', 'LastName': 'Jessup', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Rose', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mullen', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Raymond', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Ellen G', 'Initials': 'EG', 'LastName': 'Moquete', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': ""O'Sullivan"", 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Marks', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Iribarne', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Friedhelm', 'Initials': 'F', 'LastName': 'Beyersdorf', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Borger', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Arnar', 'Initials': 'A', 'LastName': 'Geirsson', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Bagiella', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hung', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Annetine C', 'Initials': 'AC', 'LastName': 'Gelijns', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': ""O'Gara"", 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': 'Gorav', 'Initials': 'G', 'LastName': 'Ailawadi', 'Affiliation': ""From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.),\xa0Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2115961']
3173,34770227,Effects of the Healing Beats Program among University Students after Exposure to a Source of Psychological Stress: A Randomized Control Trial.,"This study is a randomized pre- and post-controlled trial to determine the effects of the Healing Beats program on anxiety, autonomic nervous balance, Bispectral (BIS) index, and heart rate among university students after exposure to a source of mental stress. Data were collected from candidates who volunteered from November 2018 to May 2019 in response to recruitment announcements. The analysis was performed using data of 99 participants in three groups: 32 in an experimental group, 35 in a placebo group, and 32 in a control group. The experimental group who received treatment via the Healing Beats program exhibited a significant effect on calming anxiety, autonomic nervous balance, BIS index, and heart rate, compared with the placebo group and the control group. The group interaction also showed a significant difference. The Healing Beats program can be used as an effective intervention for sedation in clinical situations or calmness in stressful situations in everyday life. Specifically, the Healing Beats program could serve as basic data for nursing interventions, according to the stability effect in stressful situations; it can also be applied to effective nursing practice as an initial study to confirm theoretical and practical indicators.",2021,"The experimental group who received treatment via the Healing Beats program exhibited a significant effect on calming anxiety, autonomic nervous balance, BIS index, and heart rate, compared with the placebo group and the control group.","['Data were collected from candidates who volunteered from November 2018 to May 2019 in response to recruitment announcements', '99 participants in three groups: 32 in an experimental group, 35 in a placebo group, and 32 in a control group', 'University Students after Exposure to a Source of Psychological Stress', 'university students after exposure to a source of mental stress']","['Healing Beats program', 'Healing Beats Program', 'placebo']","['calming anxiety, autonomic nervous balance, BIS index, and heart rate', 'anxiety, autonomic nervous balance, Bispectral (BIS) index, and heart rate']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}]",,0.0157017,"The experimental group who received treatment via the Healing Beats program exhibited a significant effect on calming anxiety, autonomic nervous balance, BIS index, and heart rate, compared with the placebo group and the control group.","[{'ForeName': 'Jiah', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'College of Nursing, Konyang University, 158 Gwanjeodong-ro, Seo-gu, Daejeon 35365, Korea.'}, {'ForeName': 'Wonjong', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Eulji University, 712 Dongil-ro, Uijeongbu-si 11759, Korea.'}, {'ForeName': 'Iklyul', 'Initials': 'I', 'LastName': 'Bae', 'Affiliation': 'College of Nursing, International University of Korea, 965 Dongbu-ro, Munsan-eup, Jinju-si 52833, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph182111716']
3174,34770194,Effect of Vibration Massage and Passive Rest on Recovery of Muscle Strength after Short-Term Exercise.,"BACKGROUND


The aim of the study was to compare the effect of vibration massage and passive rest on accelerating the process of muscle recovery after short-term intense exercise.
METHODS


Eighty-four healthy men aged 20 to 25 years participated in the study. Study participants performed isometric (ISO-M Group) and auxotonic (AUX-M group) contraction exercise in the lower limbs. Vibration massage was administered after exercise in the first recovery period. In the same period, controls rested passively, without the support of vibration massage. To assess the effectiveness of the applied vibration, a 4-fold measurement of the maximum force of the muscles involved in the exercise was performed under conditions of isometric contractions on a leg press machine set at an angle of 45° degrees upwards.
RESULTS


Differences in maximum strength during isometric contraction were found compared to baseline in favor of the groups subjected to the experimental vibration massage. Differences were demonstrated in muscle strength between the study groups ( p  < 0.005). The second period of passive rest in all groups did not bring significant changes in the values of maximal lower limb strength.
CONCLUSIONS


Properly selected characteristics of the vibration effect can be an effective method in accelerating recovery and regaining lost motor capabilities of muscle groups fatigued by exercise. This offers the potential to shorten rest periods between sets of repetitions in training or between training units.",2021,"RESULTS


Differences in maximum strength during isometric contraction were found compared to baseline in favor of the groups subjected to the experimental vibration massage.",['Eighty-four healthy men aged 20 to 25 years participated in the study'],"['vibration massage and passive rest', 'isometric (ISO-M Group) and auxotonic (AUX-M group) contraction exercise', 'Vibration massage', 'Vibration Massage and Passive Rest']","['Recovery of Muscle Strength', 'maximum strength during isometric contraction', 'muscle strength', 'values of maximal lower limb strength']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",84.0,0.0214967,"RESULTS


Differences in maximum strength during isometric contraction were found compared to baseline in favor of the groups subjected to the experimental vibration massage.","[{'ForeName': 'Wiesław', 'Initials': 'W', 'LastName': 'Chwała', 'Affiliation': 'The Department of Biomechanics, University of Physical Education, Al. Jana Pawla II 78, 31-571 Cracow, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Pogwizd', 'Affiliation': 'Research and Development Department of Vitberg, Marcina Borelowskiego 29, 33-300 Nowy Sącz, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Rydzik', 'Affiliation': 'Institute of Sports Sciences, University of Physical Education, 31-571 Krakow, Poland.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Ambroży', 'Affiliation': 'Institute of Sports Sciences, University of Physical Education, 31-571 Krakow, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph182111680']
3175,34770193,Effect of Oral Health Education Using a Mobile App (OHEMA) on the Oral Health and Swallowing-Related Quality of Life in Community-Based Integrated Care of the Elderly: A Randomized Clinical Trial.,"This study investigated the effect of oral health education using a mobile app (OHEMA) on the oral health and swallowing-related quality of life (SWAL-QoL) of the elderly population in a community-based integrated care project (CICP). Forty elderly individuals in the CICP were randomized into intervention and control groups. OHEMA provided information on customized oral health care management, oral exercises, and intraoral and extraoral massage methods for 50 min/session, once a week, for 6 weeks. Pre- and post-intervention surveys assessed the unstimulated salivary flow rate, subjective oral dryness, tongue pressure, and SWAL-QoL, which were analyzed using ANCOVA and repeated measures ANOVA. In the intervention group, tongue pressure increased significantly from pre- (17.75) to post-intervention (27.24) ( p  < 0.001), and subjective oral dryness decreased from pre- (30.75) to post-intervention (18.50). The unstimulated salivary flow rate had a higher mean score in the intervention group (7.19) than in the control group (5.04) ( p  < 0.001). The SWAL-QoL significantly improved from pre- (152.10) to post-intervention (171.50) in the intervention group ( p  < 0.001) but did not change significantly in the control group ( p  > 0.05). OHEMA appears to be a useful tool for oral health education for the elderly as it improved the SWAL-QoL, with increased tongue pressure and reduced oral dryness.",2021,"OHEMA appears to be a useful tool for oral health education for the elderly as it improved the SWAL-QoL, with increased tongue pressure and reduced oral dryness.","['elderly population in a community-based integrated care project (CICP', 'Forty elderly individuals in the CICP', 'Community-Based Integrated Care of the Elderly']","['Oral Health Education Using a Mobile App (OHEMA', 'OHEMA', 'oral health education using a mobile app (OHEMA']","['unstimulated salivary flow rate, subjective oral dryness, tongue pressure, and SWAL-QoL', 'Oral Health and Swallowing-Related Quality of Life', 'SWAL-QoL', 'oral health and swallowing-related quality of life (SWAL-QoL', 'unstimulated salivary flow rate', 'tongue pressure', 'subjective oral dryness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",40.0,0.0187787,"OHEMA appears to be a useful tool for oral health education for the elderly as it improved the SWAL-QoL, with increased tongue pressure and reduced oral dryness.","[{'ForeName': 'Ji-Yun', 'Initials': 'JY', 'LastName': 'Ki', 'Affiliation': 'Department of Public Health, Graduate School, Dankook University, Cheonan-si 31116, Korea.'}, {'ForeName': 'Se-Rim', 'Initials': 'SR', 'LastName': 'Jo', 'Affiliation': 'Department of Public Health, Graduate School, Dankook University, Cheonan-si 31116, Korea.'}, {'ForeName': 'Kyung-Sook', 'Initials': 'KS', 'LastName': 'Cho', 'Affiliation': 'Department of Public Health, Graduate School, Dankook University, Cheonan-si 31116, Korea.'}, {'ForeName': 'Jung-Eun', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Department of Dental Hygiene, College of Health Science, Dankook University, Cheonan-si 31116, Korea.'}, {'ForeName': 'Ja-Won', 'Initials': 'JW', 'LastName': 'Cho', 'Affiliation': 'Department of Preventive Dentistry, College of Dentistry, Dankook University, Cheonan-si 31116, Korea.'}, {'ForeName': 'Jong-Hwa', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Department of Public Health, Graduate School, Dankook University, Cheonan-si 31116, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph182111679']
3176,34770188,Development and Testing of a Community-Based Intervention to Address Intimate Partner Violence among Rohingya and Syrian Refugees: A Social Norms-Based Mental Health-Integrated Approach.,"Intimate partner violence (IPV) is the leading form of gender-based violence globally and increases during times of conflict and displacement. To reduce IPV and encourage help-seeking, a two-phase community-based intervention was co-designed with Rohingya in Malaysia and Syrians in Lebanon. Three day workshops, utilizing a social norms-based mental health-integrated approach, were implemented for women and men in each country ( n  = 148). Pre- to post-measures indicated reductions in beliefs about acceptability of violence and rigid gender norms, and improvements in mental health, functioning, coping, and self-efficacy for women and men following workshop participation. Workshop participation was also associated with increased help-seeking intent, for both mental health and IPV (victims and perpetrators). Workshops included community design of poster campaigns to address IPV, which were then tested in each setting using a randomized controlled trial in Malaysia ( n  = 240) and a matched cluster comparison in Lebanon ( n  = 260). Women in both settings found IPV less acceptable in the poster condition. Help-seeking preferences were also influenced by the poster for women and men in both countries. This participatory intervention research can provide a roadmap for use in other settings, emphasizing the value of community-generated solutions to IPV among displaced populations.",2021,"Workshop participation was also associated with increased help-seeking intent, for both mental health and IPV (victims and perpetrators).","['Intimate Partner Violence among Rohingya and Syrian Refugees', 'Malaysia ( n  = 240) and a matched cluster comparison in Lebanon ( n  = 260', 'women and men in each country ( n  = 148', 'Intimate partner violence (IPV']",[],"['beliefs about acceptability of violence and rigid gender norms, and improvements in mental health, functioning, coping, and self-efficacy']","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0018561', 'cui_str': 'Mesocricetus auratus'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0454664', 'cui_str': 'Country'}]",[],"[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0355113,"Workshop participation was also associated with increased help-seeking intent, for both mental health and IPV (victims and perpetrators).","[{'ForeName': 'Leah Emily', 'Initials': 'LE', 'LastName': 'James', 'Affiliation': 'Institute of Behavioral Science, University of Colorado, Boulder, CO 80309, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Welton-Mitchell', 'Affiliation': 'Institute of Behavioral Science, University of Colorado, Boulder, CO 80309, USA.'}, {'ForeName': 'Saja', 'Initials': 'S', 'LastName': 'Michael', 'Affiliation': 'ABAAD, Beirut, Lebanon.'}, {'ForeName': 'Fajar', 'Initials': 'F', 'LastName': 'Santoadi', 'Affiliation': 'Tenaganita, Petaling Jaya 46000, Selangor, Malaysia.'}, {'ForeName': 'Sharifah', 'Initials': 'S', 'LastName': 'Shakirah', 'Affiliation': 'Tenaganita, Petaling Jaya 46000, Selangor, Malaysia.'}, {'ForeName': 'Hasnah', 'Initials': 'H', 'LastName': 'Hussin', 'Affiliation': 'Tenaganita, Petaling Jaya 46000, Selangor, Malaysia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Anwar', 'Affiliation': 'Tenaganita, Petaling Jaya 46000, Selangor, Malaysia.'}, {'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Kilzar', 'Affiliation': 'ABAAD, Beirut, Lebanon.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'James', 'Affiliation': 'Institute of Behavioral Science, University of Colorado, Boulder, CO 80309, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph182111674']
3177,34772453,Evaluation of a health education program for improving uptake of HIV self-testing by men in Rwanda: a pilot pragmatic randomized control trial.,"BACKGROUND


Health education interventions tailored to suit men have the potential to improve health outcomes for this underserved population. HIV self-testing (HIVST) is a promising approach to overcoming challenges associated with low HIV testing rates among men. The primary objective of this study is to assess the feasibility of conducting a definitive trial to determine the effectiveness of a locally adapted and optimized health education program (HEP) on the uptake of HIVST among men in Kigali, Rwanda.
METHODS


This study employs a pilot pragmatic randomized controlled trial to evaluate an HIVST HEP for men. Participants were randomized to the intervention (HEP) arm or to the control arm. In the intervention group, the adapted HEP was administered in addition to routine health education. In the non-intervention group, only routine health education was offered. Participant data was collected first upon recruitment and then after 3 months' follow-up using interviewer-administered questionnaires.
RESULTS


There was a 100% response rate at enrollment and no loss to follow-up at exit. There was significant association between the study arm and knowledge of HIVST. Participants in the control arm had a mean knowledge score of 67% compared to 92% among participants in the intervention arm. There was an association between the study arm and HIVST uptake: 67% of the study participants in the intervention arm self-reported HIVST uptake compared to 23% of the participants in the control arm.
DISCUSSION


This pilot study demonstrates the feasibility of a larger trial to assess the effectiveness of an HEP intervention on uptake of HIVST among men. We found preliminary evidence of increased uptake of HIVST in the intervention group.
TRIAL REGISTRATION


Pan African Clinical Trial Registry PACTR201908758321490 . Registered on 8 August 2019.",2021,Participants in the control arm had a mean knowledge score of 67% compared to 92% among participants in the intervention arm.,"['men', 'for men', 'HIV self-testing by men in Rwanda']","['HIV self-testing (HIVST', 'locally adapted and optimized health education program (HEP', 'HEP intervention', 'health education program', 'adapted HEP', 'HIVST HEP']","['HIVST uptake', 'uptake of HIVST', 'mean knowledge score']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.087431,Participants in the control arm had a mean knowledge score of 67% compared to 92% among participants in the intervention arm.,"[{'ForeName': 'Tafadzwa', 'Initials': 'T', 'LastName': 'Dzinamarira', 'Affiliation': 'Department of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, 4001, South Africa. anthonydzina@gmail.com.'}, {'ForeName': 'Claude Mambo', 'Initials': 'CM', 'LastName': 'Muvunyi', 'Affiliation': 'College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda.'}, {'ForeName': 'Tivani Phosa', 'Initials': 'TP', 'LastName': 'Mashamba-Thompson', 'Affiliation': 'Department of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, 4001, South Africa.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00940-x']
3178,34772441,Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL).,"BACKGROUND


The advised standard treatment for bacterial brain abscess following surgery is 6 to 8 weeks of intravenous (IV) antibiotic treatment, but an early switch to oral antibiotic treatment has been suggested to be equally effective.
METHODS


This investigator-initiated, international, multi-center, parallel group, open-label, randomized (1:1 allocation) controlled trial will examine if oral treatment after 2 weeks of IV antibiotic therapy is non-inferior to standard 6-8 weeks of IV antibiotics for bacterial brain abscess in adults (≥ 18 years of age). The study will be conducted at hospitals across Denmark, the Netherlands, France, Australia, and Sweden. Exclusion criteria are severe immunocompromise or impaired gastro-intestinal absorption, pregnancy, device-related brain abscesses, and brain abscess caused by nocardia, tuberculosis, or Pseudomonas spp. The primary objective is a composite endpoint at 6 months after randomization consisting of all-cause mortality, intraventricular rupture of brain abscess, unplanned re-aspiration or excision of brain abscess, relapse, or recurrence. The primary endpoint will be adjudicated by an independent blinded endpoint committee. Secondary outcomes include extended Glasgow Outcome Scale scores and all-cause mortality at end of treatment as well as 3, 6, and 12 months since randomization, completion of assigned treatment, IV catheter associated complications, durations of admission and antibiotic treatment, severe adverse events, quality of life scores, and cognitive evaluations. The planned sample size is 450 patients for a one-sided alpha of 0.025 and a power of 90% to exclude a difference in favor of standard treatment of more than 10%. Date of initiation of first study center was November 3, 2020, with active recruitment for 3 years and follow-up for 1 year of all patients.
DISCUSSION


The results of this study may guide future recommendations for treatment of bacterial brain abscess. If early transition to oral antibiotics proves non-inferior to standard IV treatment, this will provide considerable health and costs benefits.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04140903, first registered 28.10.2019. EudraCT number: 2019-002845-39, first registered 03.07.2019.",2021,"If early transition to oral antibiotics proves non-inferior to standard IV treatment, this will provide considerable health and costs benefits.
","['hospitals across Denmark, the Netherlands, France, Australia, and Sweden', 'bacterial brain abscess', 'adults (≥ 18\u2009years of age']",['Partial oral antibiotic treatment'],"['cause mortality, intraventricular rupture of brain abscess, unplanned re-aspiration or excision of brain abscess, relapse, or recurrence', 'extended Glasgow Outcome Scale scores and all-cause mortality at end of treatment as well as 3, 6, and 12 months since randomization, completion of assigned treatment, IV catheter associated complications, durations of admission and antibiotic treatment, severe adverse events, quality of life scores, and cognitive evaluations']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0006105', 'cui_str': 'Abscess of brain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0006105', 'cui_str': 'Abscess of brain'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0195960', 'cui_str': 'Excision of brain'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0297096', 'cui_str': 'arsenotriglutathione'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",,0.266731,"If early transition to oral antibiotics proves non-inferior to standard IV treatment, this will provide considerable health and costs benefits.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bodilsen', 'Affiliation': 'Department of Infectious Diseases, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark. Jacob.bodilsen@rn.dk.'}, {'ForeName': 'Matthijs C', 'Initials': 'MC', 'LastName': 'Brouwer', 'Affiliation': 'European Society for Clinical Microbiology and Infectious Diseases Study Group of Infections in the Brain (ESCMID), Basel, Switzerland.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'van de Beek', 'Affiliation': 'European Society for Clinical Microbiology and Infectious Diseases Study Group of Infections in the Brain (ESCMID), Basel, Switzerland.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Tattevin', 'Affiliation': 'European Society for Clinical Microbiology and Infectious Diseases Study Group of Infections in the Brain (ESCMID), Basel, Switzerland.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Tong', 'Affiliation': 'Victorian Infectious Diseases Service, The Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'Pontus', 'Initials': 'P', 'LastName': 'Naucler', 'Affiliation': 'Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Nielsen', 'Affiliation': 'European Society for Clinical Microbiology and Infectious Diseases Study Group of Infections in the Brain (ESCMID), Basel, Switzerland.'}]",Trials,['10.1186/s13063-021-05783-8']
3179,34772437,The economic impact of two diagnostic strategies in the management of restorations in primary teeth: a health economic analysis plan for a trial-based economic evaluation.,"BACKGROUND


Different approaches have been used by dentists to base their decision. Among them, there are the aesthetical issues that may lead to more interventionist approaches. Indeed, using a more interventionist strategy (the World Dental Federation - FDI), more replacements tend to be indicated than using a minimally invasive one (based on the Caries Around Restorations and Sealants-CARS). Since the resources related to the long-term health effects of these strategies have not been explored, the economic impact of using the less-invasive strategy is still uncertain. Thus, this health economic analysis plan aims to describe methodologic approaches for conducting a trial-based economic evaluation that aims to assess whether a minimally invasive strategy is more efficient in allocating resources than the conventional strategy for managing restorations in primary teeth and extrapolating these findings to a longer time horizon.
METHODS


A trial-based economic evaluation will be conducted, including three cost-effectiveness analyses (CEA) and one cost-utility analysis (CUA). These analyses will be based on the main trial (CARDEC-03/ NCT03520309 ), in which children aged 3 to 10 were included and randomized to one of the diagnostic strategies (based on FDI or CARS). An examiner will assess children's restorations using the randomized strategy, and treatment will be recommended according to the same criteria. The time horizon for this study is 2 years, and we will adopt the societal perspective. The average costs per child for 24 months will be calculated. Three different cost-effectiveness analyses (CEA) will be performed. For CEAs, the effects will be the number of operative interventions (primary CEA analysis), the time to these new interventions, the percentage of patients who did not need new interventions in the follow-up, and changes in children's oral health-related quality of life (secondary analyses). For CUA, the effect will be tooth-related quality-adjusted life years (QALYs). Intention-to-treat analyses will be conducted. Finally, we will assess the difference when using the minimally invasive strategy for each health effect (∆effect) compared to the conventional strategy (based on FDI) as the reference strategy. The same will be calculated for related costs (∆cost). The discount rate of 5% will be applied for costs and effects. We will perform deterministic and probabilistic sensitivity analyses to handle uncertainties. The net benefit will be calculated, and acceptability curves plotted using different willingness-to-pay thresholds. Using Markov models, a longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon.
DISCUSSION


The main trial is ongoing, and data collection is still not finished. Therefore, economic evaluation has not commenced. We hypothesize that conventional strategy will be associated with more need for replacements of restorations in primary molars. These replacements may lead to more reinterventions, leading to higher costs after 2 years. The health effects will be a crucial aspect to take into account when deciding whether the minimally invasive strategy will be more efficient in allocating resources than the conventional strategy when considering the management of restorations in primary teeth. Finally, patients/parents preferences and consequent utility values may also influence this final conclusion about the economic aspects of implementing the minimally invasive approach for managing restorations in clinical practice. Therefore, these trial-based economic evaluations may bring actual evidence of the economic impact of such interventions.
TRIAL REGISTRATION


NCT03520309 . Registered May 9, 2018. Economic evaluations (the focus of this plan) are not initiated at the moment.",2021,"Using Markov models, a longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon.
","['restorations in primary teeth', 'children aged 3 to 10']",[],[],"[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],[],,0.0467958,"Using Markov models, a longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon.
","[{'ForeName': 'Raíza Dias', 'Initials': 'RD', 'LastName': 'Freitas', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil.'}, {'ForeName': 'Bruna Lorena Pereira', 'Initials': 'BLP', 'LastName': 'Moro', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil.'}, {'ForeName': 'Laura Regina Antunes', 'Initials': 'LRA', 'LastName': 'Pontes', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil.'}, {'ForeName': 'Haline Cunha Medeiros', 'Initials': 'HCM', 'LastName': 'Maia', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Passaro', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil.'}, {'ForeName': 'Rodolfo Carvalho', 'Initials': 'RC', 'LastName': 'Oliveira', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil.'}, {'ForeName': 'Jonathan Rafael', 'Initials': 'JR', 'LastName': 'Garbim', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil.'}, {'ForeName': 'Maria Eduarda Franco', 'Initials': 'MEF', 'LastName': 'Vigano', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil.'}, {'ForeName': 'Tamara Kerber', 'Initials': 'TK', 'LastName': 'Tedesco', 'Affiliation': 'School of Clinical Dentistry, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Deery', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil.'}, {'ForeName': 'Maximiliano Sergio', 'Initials': 'MS', 'LastName': 'Cenci', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil. mmbraga@usp.br.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-021-05722-7']
3180,34772901,Tart Cherry Supplement Enhances Skeletal Muscle Glutathione Peroxidase Expression and Functional Recovery after Muscle Damage.,"INTRODUCTION


Montmorency cherry concentrate (MCC) supplementation enhances functional recovery from exercise, potentially due to antioxidant and anti-inflammatory effects. However, to date, supporting empirical evidence for these mechanistic hypotheses is reliant on indirect blood biomarkers. This study is the first to investigate functional recovery from exercise alongside molecular changes within the exercised muscle following MCC supplementation.
METHODS


Ten participants completed two maximal unilateral eccentric knee extension trials following MCC or placebo supplementation for 7 days prior to and 48 hours following exercise. Knee extension maximum voluntary isometric contractions (MVC), maximal isokinetic contractions, single leg jumps, and soreness measures were assessed before, immediately, 24 and 48 h after exercise. Venous blood and vastus lateralis muscle samples were collected at each time point. Plasma concentrations of IL-6, TNF-α, C-reactive protein, creatine kinase, and phenolic acids were quantified. Intramuscular mRNA expression of SOD 1 and 3, GPX1, 3, 4 and 7, Catalase, and Nrf2 and relative intramuscular protein expression of SOD1, Catalase and GPX3 were quantified.
RESULTS


MCC supplementation enhanced recovery of normalized MVC 1 s average compared to placebo (Post- Exercise PLA: 59.5 ± 18.0% vs MCC: 76.5 ± 13.9%; 24 h PLA: 69.8 ± 15.9% vs MCC: 80.5 ± 15.3%; supplementation effect p = 0.024). MCC supplementation increased plasma hydroxybenzoic, hippuric and vanillic acid concentrations (supplementation effect p = 0.028, p = 0.002, p = 0.003); SOD3, GPX3, GPX4, GPX7 (supplement effect p < 0.05) and GPX1 (interaction effect p = 0.017) gene expression; and GPX3 protein expression (supplementation effect p = 0.004) versus placebo. There were no significant differences between conditions for other outcome measures.
CONCLUSION


MCC supplementation conserved isometric muscle strength and upregulated antioxidant gene and protein expression in parallel with increased phenolic acid concentrations.",2021,"Intramuscular mRNA expression of SOD 1 and 3, GPX1, 3, 4 and 7, Catalase, and Nrf2 and relative intramuscular protein expression of SOD1, Catalase and GPX3 were quantified.
",['Ten participants completed two maximal unilateral eccentric knee extension trials following'],"['Montmorency cherry concentrate (MCC) supplementation', 'MCC or placebo supplementation', 'placebo', 'MCC supplementation']","['Knee extension maximum voluntary isometric contractions (MVC), maximal isokinetic contractions, single leg jumps, and soreness measures', 'Plasma concentrations of IL-6, TNF-α, C-reactive protein, creatine kinase, and phenolic acids', 'Skeletal Muscle Glutathione Peroxidase Expression and Functional Recovery', 'isometric muscle strength and upregulated antioxidant gene and protein expression', 'Venous blood and vastus lateralis muscle samples', 'plasma hydroxybenzoic, hippuric and vanillic acid concentrations (supplementation effect', 'recovery of normalized MVC', 'GPX1 (interaction effect p = 0.017) gene expression; and GPX3 protein expression', 'Intramuscular mRNA expression of SOD 1 and 3, GPX1, 3, 4 and 7, Catalase, and Nrf2 and relative intramuscular protein expression of SOD1, Catalase and GPX3']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0330657', 'cui_str': 'Prunus cerasus'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C2586298', 'cui_str': 'Hydroxybenzoic acid'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0042315', 'cui_str': 'Vanillic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",10.0,0.212211,"Intramuscular mRNA expression of SOD 1 and 3, GPX1, 3, 4 and 7, Catalase, and Nrf2 and relative intramuscular protein expression of SOD1, Catalase and GPX3 were quantified.
","[{'ForeName': 'Jimmy T', 'Initials': 'JT', 'LastName': 'Wangdi', 'Affiliation': ""School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, QLD, Australia Sport and Health Sciences, St Luke's Campus, University of Exeter, Exeter, Devon, United Kingdom School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, QLD, Australia Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich, Norfolk, United Kingdom.""}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': ""O'Leary"", 'Affiliation': ''}, {'ForeName': 'Vincent G', 'Initials': 'VG', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Jackman', 'Affiliation': ''}, {'ForeName': 'Jonathan C Y', 'Initials': 'JCY', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dutton', 'Affiliation': ''}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Bowtell', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002827']
3181,34772900,Low-Load Blood Flow Restriction and High-Load Resistance Training Induce Comparable Changes in Patellar Tendon Properties.,"INTRODUCTION


Low-load resistance training with blood flow restriction (LL-BFR) has emerged as a viable alternative to conventional high-load (HL) resistance training regimens. Despite increasing evidence confirming comparable muscle adaptations between LL-BFR and HL resistance exercise, only very little is known about tendinous mechanical and morphological adaptations following LL-BFR. Therefore, the aim of the present study was to examine the effects of 14 weeks of LL-BFR and HL training on patellar tendon adaptations.
METHODS


N = 29 recreationally active male participants were randomly allocated into the following two groups: LL-BFR resistance training (20-35% one repetition maximum/1RM) or HL resistance training (70-85% 1RM). Both groups trained three times per week for 14 weeks. One week before and after the intervention, patellar tendon mechanical and morphological properties were assessed via ultrasound and magnetic resonance imaging (MRI). Additionally, changes in muscle cross-sectional area (CSA) were quantified by MRI and muscle strength via dynamic 1RM measurements.
RESULTS


The findings demonstrated that both LL-BFR and HL training resulted in comparable changes in patellar tendon stiffness (LL-BFR: + 25.2%, p = 0.003; HL: + 22.5%, p = 0.024) without significant differences between groups. Similar increases in tendon CSA were observed in HL and LL-BFR. Muscle mass and strength also significantly increased in both groups but were not statistically different between HL (+ 38%) and LL-BFR (+ 34%), except for knee extension 1RM where higher changes were seen in LL-BFR.
CONCLUSION


The present results support the notion that both HL and LL-BFR cause substantial changes in patellar tendon properties and the magnitude of changes are not significantly different between conditions. Further studies are needed which examine the physiological mechanisms underlying the altered tendon properties following LL-BFR training.",2021,"Muscle mass and strength also significantly increased in both groups but were not statistically different between HL (+ 38%) and LL-BFR (+ 34%), except for knee extension 1RM where higher changes were seen in LL-BFR.
",['N = 29 recreationally active male participants'],"['Low-load resistance training with blood flow restriction (LL-BFR', 'LL-BFR and HL training', 'Low-Load Blood Flow Restriction and High-Load Resistance Training', 'LL-BFR resistance training (20-35% one repetition maximum/1RM) or HL resistance training']","['Muscle mass and strength', 'knee extension 1RM', 'patellar tendon properties', 'changes in muscle cross-sectional area (CSA', 'tendon CSA', 'LL-BFR', 'patellar tendon stiffness']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",29.0,0.0203582,"Muscle mass and strength also significantly increased in both groups but were not statistically different between HL (+ 38%) and LL-BFR (+ 34%), except for knee extension 1RM where higher changes were seen in LL-BFR.
","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Centner', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Germany Praxisklinik Rennbahn, Muttenz, Switzerland Department of Neurosciences and Movement Sciences, Université de Fribourg, Switzerland Department of Physical Performance, Norwegian School of Sport Sciences, Norway Department of Sports Science, Institute for Nutrition, Sports and Health, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Jerger', 'Affiliation': ''}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Lauber', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Seynnes', 'Affiliation': ''}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Friedrich', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lolli', 'Affiliation': ''}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Gollhofer', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'König', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002824']
3182,34772860,Tissue selecting technique for adult women with low rectovaginal fistula.,"BACKGROUND


This study aimed to assess the effect of tissue selecting technique (TST) on low rectovaginal fistula (RVF) repair.
METHODS


Patients with low RVF were included in the prospective study from August 2009 and January 2013 in xx hospital. Patients assigned to the TST or control groups based on the different surgical methods. Surgical success, complications and quality of life were evaluated. Patients were followed up for 1-3 years.
RESULTS


A total of 81 patients were included in the study. Foutry-one were in the TST group and fourty were in the control group. Surgery was successful in 100% of patients who underwent TST, and in 95% of patients who underwent the classical perineal approach. Less patients experienced pain (72% vs. 90%, p=0.04) and edema (6% vs. 25%, p<0.001) in the TST group compared with the control group. In addition, the QOL score was significantly higher in the TST group (122±21 vs. 111±12,p=0.02).
CONCLUSION


The TST stapler approach appears to be appropriate for the treatment of low RVF in adults.",2021,"Less patients experienced pain (72% vs. 90%, p=0.04) and edema (6% vs. 25%, p<0.001) in the TST group compared with the control group.","['adult women with low rectovaginal fistula', 'A total of 81 patients were included in the study', 'Patients with low RVF were included in the prospective study from August 2009 and January 2013 in xx hospital']","['tissue selecting technique (TST', 'TST']","['pain', 'Surgical success, complications and quality of life', 'edema', 'QOL score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034895', 'cui_str': 'Rectovaginal fistula'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",81.0,0.0338861,"Less patients experienced pain (72% vs. 90%, p=0.04) and edema (6% vs. 25%, p<0.001) in the TST group compared with the control group.","[{'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Ju', 'Affiliation': ""Department of Anoretal Surgery, Liaocheng People's Hospital, Shandong, China Department of Ggynaecology and Obstetrics, Liaocheng People's Hospital, Shandong, China.""}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Chaofeng', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Yingdong', 'Initials': 'Y', 'LastName': 'Ju', 'Affiliation': ''}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000663']
3183,34772849,Oncostatin M: a Potential Biomarker to Predict Infection in Patients with Left Ventricular Assist Devices.,"Infection is a serious adverse event limiting left ventricular assist device (LVAD) therapy in advanced heart failure patients, but a reliable means to identify patients at increased risk of infection is still lacking. We hypothesized that preoperative elevated levels of plasma Oncostatin M (OSM), a cytokine marker of leukocyte activation and inflammation, would be predictive of subsequent infection. We measured plasma OSM in 41 LVAD patients one day before LVAD implantation and postoperatively over two months. Preoperative plasma OSM levels were normal in 27 patients (group A, 4.9 ± 3.2 pg/ml) but elevated in 14 patients (group B, 1649.0 ± 458.9 pg/ml) (p = 0.003). Early postoperative levels rose in both groups and declined rapidly in group A, with group B declining slowly over two months. Significantly more infections developed in group B than group A patients over two months postimplantation (p = 0.004). No other routine clinical assessment or laboratory testing afforded this differentiation. These findings suggest that preoperative plasma OSM levels may assist in identifying patients at increased risk of infections after LVAD implantation.",2021,Significantly more infections developed in group B than group A patients over two months postimplantation (p = 0.004).,"['Patients with Left Ventricular Assist Devices', '41 LVAD patients', 'advanced heart failure patients']",['left ventricular assist device (LVAD) therapy'],"['plasma OSM', 'plasma Oncostatin M (OSM), a cytokine marker of leukocyte activation and inflammation', 'infections', 'Early postoperative levels', 'Preoperative plasma OSM levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",41.0,0.0465456,Significantly more infections developed in group B than group A patients over two months postimplantation (p = 0.004).,"[{'ForeName': 'Hendra', 'Initials': 'H', 'LastName': 'Setiadi', 'Affiliation': 'From the INTEGRIS Advanced Cardiac Care, Nazih Zuhdi Transplant Institute, INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma and Department of Bioengineering, University of Texas at Dallas, Richardson, TX.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'El-Banayosy', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'George', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Schmidtke', 'Affiliation': ''}, {'ForeName': 'Aly', 'Initials': 'A', 'LastName': 'El-Banayosy', 'Affiliation': ''}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Horstmanshof', 'Affiliation': ''}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Long', 'Affiliation': ''}]",ASAIO journal (American Society for Artificial Internal Organs : 1992),['10.1097/MAT.0000000000001608']
3184,34772746,"Meditation involving people with cancer, medical staff and witnesses: a pilot study exploring improvement in wellness and connectedness.","INTRODUCTION


Mindfulness meditation is likely to promote better management of stress, pain and negative emotions. We propose to address the benefit of meditation in an open setting associating people with cancer (target population), medical staff and witnesses (neither patient nor medical staff). This study aims (1) to evaluate the effects of meditation on wellness improvement and (2) to identify criteria and modalities for a subsequent randomised study.
METHODS AND ANALYSIS


We propose a longitudinal pilot study consisting of a non-randomised experimental preintervention/postintervention survey. The intervention consists in delivering a meditation programme (12 weekly meditation sessions of 1.5 hours each), specifically adapted to our target population and addressing our research hypothesis in an open setting involving people with cancer, medical staff and witnesses (equally distributed in two groups of 15 participants). The main objective is to evaluate participants' adherence to the programme. The effects of meditation will be evaluated on stress, quality of life, feeling of personal effectiveness, on the development of mindfulness and empathy, and on satisfaction and perception of a change in quality of life. We will also measure the putative added value of 'meditating together'. This study is expected to allow validating the evaluation tools and refining the modalities of the workshops. We expect to demonstrate the evolution that this meditation-based intervention induces in the participants. We aim to promote bridge-building, between patients, medical staff but also others. In this way, one's own suffering may be understood in the light of others' suffering, thereby promoting the sense of otherness and giving insights into 'living better with'. This exploratory study will investigate the relevance of this hypothesis, which could then be explored by a randomised study.
ETHICS AND DISSEMINATION


The protocol was approved by the local ethics committee (Comité de Protection des Personnes Est II). Trial findings will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04410185.",2021,"The effects of meditation will be evaluated on stress, quality of life, feeling of personal effectiveness, on the development of mindfulness and empathy, and on satisfaction and perception of a change in quality of life.","['people with cancer (target population), medical staff and witnesses (neither patient nor medical staff', 'people with cancer, medical staff and witnesses']","['Meditation', 'meditation', 'Mindfulness meditation', 'meditation programme']","['quality of life', 'stress, quality of life, feeling of personal effectiveness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039309', 'cui_str': 'Target Population'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",15.0,0.061396,"The effects of meditation will be evaluated on stress, quality of life, feeling of personal effectiveness, on the development of mindfulness and empathy, and on satisfaction and perception of a change in quality of life.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Prevost', 'Affiliation': 'Normandie Université, UNICAEN, INSERM U1086 ANTICIPE, Caen, France virginie.prevost@unicaen.fr.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Clarisse', 'Affiliation': 'Centre François Baclesse Centre de Lutte Contre le Cancer, Caen, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leconte', 'Affiliation': 'Centre François Baclesse Centre de Lutte Contre le Cancer, Caen, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Delorme', 'Affiliation': 'Centre François Baclesse Centre de Lutte Contre le Cancer, Caen, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Benoit', 'Affiliation': 'Centre François Baclesse Centre de Lutte Contre le Cancer, Caen, France.'}, {'ForeName': 'Titi', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': 'Centre François Baclesse Centre de Lutte Contre le Cancer, Caen, France.'}]",BMJ open,['10.1136/bmjopen-2020-048164']
3185,34772742,An unsuccessful initiative to reduce 'spin' in biomedical literature.,"Overview of:  Ghannad M, Yang B, Leeflang M,  et al  A randomized trial of an editorial intervention to reduce spin in the abstract's conclusion of manuscripts showed no significant effect.  J Clin Epidemiol  2021;130:69-77.",2021,"Overview of:  Ghannad M, Yang B, Leeflang M,  et al  A randomized trial of an editorial intervention to reduce spin in the abstract's conclusion of manuscripts showed no significant effect.  ",[],['J Clin Epidemiol'],[],[],[],[],,0.12162,"Overview of:  Ghannad M, Yang B, Leeflang M,  et al  A randomized trial of an editorial intervention to reduce spin in the abstract's conclusion of manuscripts showed no significant effect.  ",[],Drug and therapeutics bulletin,['10.1136/dtb.2021.000059']
3186,34772740,"Aging Enhances Neural Activity in Auditory, Visual, and Somatosensory Cortices: The Common Cause Revisited.","In humans, age-related declines in vision, hearing, and touch coincide with changes in amplitude and latency of sensory evoked potentials. These age-related differences in neural activity may be related to a common deterioration of supra-modal brain areas (e.g., prefrontal cortex) that mediate activity in sensory cortices, or reflect specific sensorineural impairments that may differ between sensory modalities. To distinguish between these two possibilities, we measured neuroelectric brain activity while 37 young adults (18-30 years, 18 males) and 35 older adults (60-88 years, 20 males) were presented with a rapid randomized sequence of lateralized auditory, visual, and somatosensory stimuli. Within each sensory domain, we compared amplitudes and latencies of sensory-evoked responses, source activity, and functional connectivity (via phase-locking value) between groups. We found that older adults' early sensory-evoked responses were greater in amplitude than those of young adults in all three modalities, which coincided with enhanced source activity in auditory, visual, and somatosensory cortices. Older adults also showed stronger neural synchrony than young adults between superior prefrontal and sensory cortices, and in older adults, the degree of phase synchrony was positively correlated with the magnitude of source activity in sensory areas. Critically, older adults who showed enhanced neural activity in one sensory domain also showed enhanced activity in other modalities. Together, these findings support the common cause hypothesis of aging and highlight the role of prefrontal regions in exerting top-down control over sensory cortices. Significance Statement: A prominent theory of aging posits that age-related declines in sensory processing across domains are related to a single common neurobiological mechanism. However, the neural evidence supporting this common cause hypothesis has remained elusive. Our study revealed robust age-related changes in three sensory domains across a range of neural metrics. Importantly, older adults who showed increased neural activity within one sensory domain also showed enhanced neural activity in the other two sensory modalities. No such relation among activity in sensory cortices was observed in young adults. Age-related increases in neural activity in sensory cortices coincided with enhanced neural synchrony between the prefrontal cortex and sensory cortices, underlining the importance of the prefrontal cortex in regulating sensory processing.",2021,"We found that older adults' early sensory-evoked responses were greater in amplitude than those of young adults in all three modalities, which coincided with enhanced source activity in auditory, visual, and somatosensory cortices.","['older adults', 'Older adults', 'young adults', '37 young adults (18-30 years, 18 males) and 35 older adults (60-88 years, 20 males']",[],"['neural synchrony', 'neural activity', 'neuroelectric brain activity', 'Neural Activity in Auditory, Visual, and Somatosensory Cortices', 'source activity in auditory, visual, and somatosensory cortices', 'amplitudes and latencies of sensory-evoked responses, source activity, and functional connectivity (via phase-locking value', 'early sensory-evoked responses']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",,0.104274,"We found that older adults' early sensory-evoked responses were greater in amplitude than those of young adults in all three modalities, which coincided with enhanced source activity in auditory, visual, and somatosensory cortices.","[{'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Alain', 'Affiliation': 'Rotman Research Institute, Baycrest Centre, Ontario, Canada, M6A 2E1 calain@research.baycrest.org.'}, {'ForeName': 'Ricky', 'Initials': 'R', 'LastName': 'Chow', 'Affiliation': 'Rotman Research Institute, Baycrest Centre, Ontario, Canada, M6A 2E1.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'MOE Key Lab for Neuroinformation, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China, 611731.'}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Rabi', 'Affiliation': 'Rotman Research Institute, Baycrest Centre, Ontario, Canada, M6A 2E1.'}, {'ForeName': 'Vivek V', 'Initials': 'VV', 'LastName': 'Sharma', 'Affiliation': 'Rotman Research Institute, Baycrest Centre, Ontario, Canada, M6A 2E1.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': 'Rotman Research Institute, Baycrest Centre, Ontario, Canada, M6A 2E1.'}, {'ForeName': 'Nicole D', 'Initials': 'ND', 'LastName': 'Anderson', 'Affiliation': 'Rotman Research Institute, Baycrest Centre, Ontario, Canada, M6A 2E1.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Binns', 'Affiliation': 'Rotman Research Institute, Baycrest Centre, Ontario, Canada, M6A 2E1.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Hasher', 'Affiliation': 'Rotman Research Institute, Baycrest Centre, Ontario, Canada, M6A 2E1.'}, {'ForeName': 'Dezhong', 'Initials': 'D', 'LastName': 'Yao', 'Affiliation': 'MOE Key Lab for Neuroinformation, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China, 611731.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Freedman', 'Affiliation': 'Rotman Research Institute, Baycrest Centre, Ontario, Canada, M6A 2E1.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.0864-21.2021']
3187,34773136,Transradial versus transfemoral access for acute stroke endovascular thrombectomy: a 4-year experience in a high-volume center.,"PURPOSE


To compare clinical outcomes and safety of transradial (TRA) versus transfemoral access (TFA) for endovascular mechanical thrombectomy in acute stroke patients.
METHODS


Retrospective analysis of 832 consecutive patients with acute stroke undergoing interventional thrombectomy using TRA (n = 64) or TFA (n = 768).
RESULTS


Direct TFA failures occurred in 36 patients, 18 of which underwent crossover TFA to TRA, while direct TRA failures occurred in 2 patients having both crossovers to TFA. Successful catheterization was achieved in 96.8% (62/64) and 95.3% (732/768) of patients undergoing direct TRA and direct TFA, respectively, without significant differences. The median (IQR) catheterization time was 10 (8-16) min in the direct TRA group and 15 (10-20) in the direct TFA group (P < 0.001). This difference was also significant in the subgroup of anterior circulation strokes and in patients younger and older than 80 years of age. The majority of procedures yielded thrombolysis in cerebral infarction grade 2b/2c/3 revascularization in patients undergoing direct TRA (88.5%) and direct TFA (90.8%), without statistically significant differences. The median (IQR) puncture to recanalization time was 37 (24-58) min for the direct TRA group and 42 (28-70) min for the direct TFA group. Significant differences in access site complications, symptomatic ICH, and mRS score 0-2 at 90 days between both TRA and TFA accesses were not found.
CONCLUSIONS


TRA is not inferior to TFA in the probability of catheterization, times of catheterization and revascularization, and other clinical outcomes for mechanical thrombectomy in acute stroke.",2021,This difference was also significant in the subgroup of anterior circulation strokes and in patients younger and older than 80 years of age.,"['832 consecutive patients with acute stroke undergoing interventional thrombectomy using TRA (n\u2009=\u200964) or TFA (n\u2009=\u2009768', 'acute stroke endovascular thrombectomy', 'patients younger and older than 80\xa0years of age', 'acute stroke patients']","['Transradial versus transfemoral access', 'TRA', 'transradial (TRA) versus transfemoral access (TFA']","['anterior circulation strokes', 'median (IQR) catheterization time', 'direct TFA', 'access site complications, symptomatic ICH, and mRS score', 'direct TRA failures', 'Successful catheterization', 'cerebral infarction grade 2b/2c/3 revascularization', 'median (IQR) puncture to recanalization time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}]",832.0,0.0759874,This difference was also significant in the subgroup of anterior circulation strokes and in patients younger and older than 80 years of age.,"[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Barranco-Pons', 'Affiliation': ""Department of Interventional Neuroradiology, Hospital Universitari de Bellvitge, C/Feixa Llarga S/N, L'Hospitalet de Llobregat, 08017, Barcelona, Spain. rbarranco@bellvitgehospital.cat.""}, {'ForeName': 'Isabel Rodríguez', 'Initials': 'IR', 'LastName': 'Caamaño', 'Affiliation': ""Department of Interventional Neuroradiology, Hospital Universitari de Bellvitge, C/Feixa Llarga S/N, L'Hospitalet de Llobregat, 08017, Barcelona, Spain.""}, {'ForeName': 'Anna Nuñez', 'Initials': 'AN', 'LastName': 'Guillen', 'Affiliation': ""Service of Neurology, Hospital Universitari de Bellvitge, Fundació Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Oscar Sabino', 'Initials': 'OS', 'LastName': 'Chirife', 'Affiliation': ""Department of Interventional Neuroradiology, Hospital Universitari de Bellvitge, C/Feixa Llarga S/N, L'Hospitalet de Llobregat, 08017, Barcelona, Spain.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Quesada', 'Affiliation': ""Service of Neurology, Hospital Universitari de Bellvitge, Fundació Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Cardona', 'Affiliation': ""Service of Neurology, Hospital Universitari de Bellvitge, Fundació Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}]",Neuroradiology,['10.1007/s00234-021-02850-4']
3188,34773094,"Impact of high energy oral nutritional supplements consumed in the late afternoon on appetite, energy intake and cardio-metabolic risk factors in females with lower BMI.","BACKGROUND/OBJECTIVE


Morning consumption of a single dose of high-energy oral nutritional supplement (ONS) in females with a lower BMI displaces some of the food eaten at breakfast but increases overall daily energy intake. This study investigated the effectiveness of ONS intake in the late afternoon and for longer duration.
SUBJECTS/METHODS


Twenty-one healthy females (mean ± SD, age 25 ± 5 years; BMI 18.7 ± 1.2 kg/m 2 ) participated in a randomised, crossover study with two experimental trials. In the afternoon of days 1-5, participants consumed either ONS (2.510 MJ) or low-energy PLACEBO drink (0.377 MJ) and recorded food eaten at home. On day six, energy intake was measured during buffet meals, and energy expenditure, appetite measurements and blood samples were collected throughout the day.
RESULT


Over the 5-day period, in the ONS trial energy intake from evening meals was lower (ONS, 2.7 ± 0.25 MJ; Placebo, 3.6 ± 0.25 MJ, P = 0.01) but averaged total daily energy intake was higher (ONS, 9.2 ± 0.3 MJ; PLACEBO, 8.2 ± 0.4 MJ, P = 0.03). On day six, energy intake, appetite scores, plasma GLP-1 and PYY, and energy expenditure were not significantly different between the two trials but fasting insulin concentration and HOMA IR , were higher (P < 0.05) and insulin sensitivity score based on fasting insulin and TAG lower (P < 0.05) in ONS trial.
CONCLUSION


Late afternoon consumption of ONS for five consecutive days by females with a lower BMI has only a partial and short-lived energy intake suppression and thus increases daily energy intake but reduces insulin sensitivity.",2021,"On day six, energy intake, appetite scores, plasma GLP-1 and PYY, and energy expenditure were not significantly different between the two trials but fasting insulin concentration and HOMA IR , were higher (P < 0.05) and insulin sensitivity score based on fasting insulin and TAG lower (P < 0.05) in ONS trial.
","['females with lower BMI', 'Twenty-one healthy females (mean\u2009±\u2009SD, age 25\u2009±\u20095 years', 'females with a lower BMI displaces']","['ONS (2.510\u2009MJ) or low-energy PLACEBO drink', 'high-energy oral nutritional supplement (ONS']","['energy expenditure, appetite measurements and blood samples', 'appetite, energy intake and cardio-metabolic risk factors', 'fasting insulin concentration and HOMA IR', 'insulin sensitivity score based on fasting insulin and TAG lower', 'energy intake, appetite scores, plasma GLP-1 and PYY, and energy expenditure', 'total daily energy intake']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037293', 'cui_str': 'Skin tag'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",21.0,0.146911,"On day six, energy intake, appetite scores, plasma GLP-1 and PYY, and energy expenditure were not significantly different between the two trials but fasting insulin concentration and HOMA IR , were higher (P < 0.05) and insulin sensitivity score based on fasting insulin and TAG lower (P < 0.05) in ONS trial.
","[{'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Fatima', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Gerasimidis', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Wright', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Malkova', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK. dalia.malkova@glasgow.ac.uk.'}]",European journal of clinical nutrition,['10.1038/s41430-021-01042-w']
3189,34773302,"Combined versus conventional photodynamic therapy with 5-aminolaevulinic acid nanoemulsion (bf-200 ala) for actinic keratosis: a randomized, single-blind, prospective study.","BACKGROUND


Photodynamic therapy (PDT) has become one of the most effective therapies for the treatment of actinic keratosis, allowing the removal of more than one lesion in a single session. However, the pain sustained by the patient during treatment and local skin reactions can limit its use.
OBJECTIVES


To determine the efficacy and safety of combined PDT (daylight PDT followed by conventional PDT) vs. conventional PDT 12 weeks after treatment.
METHODS


The study was performed as a randomized, single-center, non-inferiority clinical trial with two parallel groups. A total of 51 patients with grade I and II AKs on the scalp or face were randomized. 25 patients received one session of combined PDT (combPDT) and 26 patients received one session of conventional PDT (cPDT). The primary endpoint was the reduction of AKs, 12 weeks after treatment. The secondary endpoint was the reduction in pain and local skin reaction.
RESULTS


The reduction rate of grade I and II AKs was similar in combPDT and cPDT, showing no statistically significant differences between both groups, 76.67% vs. 86.63% [p = 0.094] and 80.48% vs. 83.08% [p = 0.679], respectively. However, pain was significantly lower in the combPDT group (2.56 vs. 5, p < 0.01), as were local skin reactions.
CONCLUSIONS


CombPDT has proven to be as effective as cPDT for the treatment of grade I and II AKs located on the scalp and face. Furthermore, combPDT has been shown to be considerably more tolerable than cPDT, causing only mild local skin reactions.",2021,"However, pain was significantly lower in the combPDT group (2.56 vs. 5, p < 0.01), as were local skin reactions.
","['25 patients received', 'actinic keratosis', '51 patients with grade I and II AKs on the scalp or face were randomized']","['Photodynamic therapy (PDT', 'conventional photodynamic therapy with 5-aminolaevulinic acid nanoemulsion', 'combPDT', 'conventional PDT (cPDT', 'one session of combined PDT (combPDT', 'combined PDT (daylight PDT followed by conventional PDT) vs. conventional PDT']","['pain', 'reduction of AKs', 'reduction in pain and local skin reaction', 'pain sustained', 'efficacy and safety', 'local skin reactions', 'reduction rate of grade I and II AKs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]",51.0,0.0776203,"However, pain was significantly lower in the combPDT group (2.56 vs. 5, p < 0.01), as were local skin reactions.
","[{'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Sáenz-Guirado', 'Affiliation': 'Departament of Dermatology, University Hospital San Cecilio. Granada, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cuenca-Barrales', 'Affiliation': 'Departament of Dermatology, University Hospital Virgen de las Nieves. Granada, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Vega-Castillo', 'Affiliation': 'Departament of Dermatology, University Hospital San Cecilio. Granada, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Linares-Gonzalez', 'Affiliation': 'Departament of Dermatology, University Hospital San Cecilio. Granada, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Ródenas-Herranz', 'Affiliation': 'Departament of Dermatology, University Hospital San Cecilio. Granada, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Molina-Leyva', 'Affiliation': 'Departament of Dermatology, University Hospital Virgen de las Nieves. Granada, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ruiz-Villaverde', 'Affiliation': 'Departament of Dermatology, University Hospital San Cecilio. Granada, Spain.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12753']
3190,34773298,Long-term Follow Up of the Effectiveness of One Whole Cell and Two Acellular Pertussis Vaccines Based on a Randomized Controlled Vaccine Trial in Sweden.,"Sweden discontinued routine childhood vaccination against pertussis between 1979 and 1995. Meanwhile, various efficacy trials were performed in Sweden and elsewhere [1]. The larger of those trials was Stockholm Trial II, which included the whole country of Sweden except for the Gothenburg region.",2021,"The larger of those trials was Stockholm Trial II, which included the whole country of Sweden except for the Gothenburg region.",['Sweden'],[],[],"[{'cui': 'C0038995', 'cui_str': 'Sweden'}]",[],[],,0.122373,"The larger of those trials was Stockholm Trial II, which included the whole country of Sweden except for the Gothenburg region.","[{'ForeName': 'Bernice', 'Initials': 'B', 'LastName': 'Aronsson', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Appelqvist', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Jämtberg', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Källberg', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Olin', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Jann', 'Initials': 'J', 'LastName': 'Storsaeter', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.16184']
3191,34773292,A randomized controlled clinical trial on dose optimization of thalidomide in maintenance treatment for recurrent aphthous stomatitis.,"BACKGROUND


Recurrent aphthous stomatitis (RAS) is the most common oral mucosal disease, and ulcer-free periods are a major concern for patients. Thalidomide has been shown to be an effective systemic drug in the treatment of RAS, but the value of undertaking a trial to evaluate various maintenance doses was warranted.
METHODS


We performed this randomized, controlled, clinical trial with a two-stage design. Firstly, all the 125 cases of RAS received prednisone at a starting dose of 15 mg/d for one week as an initial therapeutic drug. Secondly, the 100 cases of RAS in the experimental group received thalidomide (50 mg/d vs. 25 mg/d) as a maintenance drug to observe its efficacy and safety.
RESULTS


During maintenance medication at the fourth and eighth weekend, the two doses (50 and 25 mg/d) of thalidomide were equivalent in reducing the incidence of ulcers, ulcer number, and ulcer pain, respectively (all P >0.05). Notably, the ulcer-free period in the group using 25 mg/d thalidomide for eight weeks was the longest (mean, >3 months) than those in the other groups (all P <0.05). Importantly, the total adverse events in the group using 25 mg/d thalidomide were significantly less than those in the group using 50 mg/d (P <0.001). Moreover, the effect of 50 mg/d thalidomide on the levels of various salivary cytokines was not superior to 25 mg/d medication (P >0.05).
CONCLUSION


This dose optimization study concluded that 25 mg/d thalidomide had a long-term effect on extending the recurrence interval of RAS with better safety.",2021,"Moreover, the effect of 50 mg/d thalidomide on the levels of various salivary cytokines was not superior to 25 mg/d medication (P >0.05).
",['recurrent aphthous stomatitis'],"['Thalidomide', 'thalidomide', 'prednisone']","['levels of various salivary cytokines', 'total adverse events', 'efficacy and safety', 'recurrence interval of RAS', 'incidence of ulcers, ulcer number, and ulcer pain']","[{'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}]","[{'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.078524,"Moreover, the effect of 50 mg/d thalidomide on the levels of various salivary cytokines was not superior to 25 mg/d medication (P >0.05).
","[{'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shanghai Xin Hua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Yufeng', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai, China.""}, {'ForeName': 'Guanhuan', 'Initials': 'G', 'LastName': 'Du', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai, China.""}, {'ForeName': 'Guoyao', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai, China.""}]",Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology,['10.1111/jop.13259']
3192,34773261,Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one-year extension study.,"BACKGROUND


Ligelizumab, a next-generation, humanized anti-immunoglobulin E (IgE) monoclonal antibody is in development as a treatment for patients with chronic spontaneous urticaria, whose symptoms are inadequately controlled with standard-of-care therapy.
OBJECTIVE


To evaluate the long-term safety and re-treatment efficacy of ligelizumab 240 mg in patients who completed the core study and extension study.
METHODS


This open-label, single-arm, long-term Phase 2b extension study was designed to assess patients who were previously administered various doses of ligelizumab, omalizumab or placebo in the Phase 2b, dose-finding core study and who presented with active disease after Week 32. In the extension study, patients received ligelizumab 240 mg subcutaneously every 4 weeks, for 52 weeks and were monitored post-treatment for 48 weeks.
RESULTS


Overall, ligelizumab was well-tolerated with no newly identified safety signals. A total of 95.4% (226/237) screened patients received ligelizumab 240 mg in the extension study; 84.1% (190/226) of patients experienced at least one treatment-emergent adverse event. Most reported events were mild (41.6%) or moderate (35.8%) and mostly unrelated to the study treatment. At Week 12, 46.5% of patients had a complete response increasing to 53.1% after 52 weeks. Following 52 weeks of extension study treatment, 75.8% [95% confidence interval, 69.9, 81.3] of patients had cumulative complete responses. The median time to relapse in complete responders was 38 weeks.
CONCLUSION


The long-term safety profile of ligelizumab 240 mg in patients with chronic spontaneous urticaria was consistent with the core study and re-treatment efficacy was shown.",2021,"At Week 12, 46.5% of patients had a complete response increasing to 53.1% after 52 weeks. ","['patients with chronic spontaneous urticaria', 'patients who completed the core study and extension study']","['ligelizumab', 'ligelizumab, omalizumab or placebo']",['median time to relapse'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C4041919', 'cui_str': 'ligelizumab'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.0852026,"At Week 12, 46.5% of patients had a complete response increasing to 53.1% after 52 weeks. ","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Giménez-Arnau', 'Affiliation': 'Dermatology Department, Hospital del Mar, IMIM Universitat Autònoma Barcelona, Spain.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, OH, USA.'}, {'ForeName': 'Chia-Yu', 'Initials': 'CY', 'LastName': 'Chu', 'Affiliation': 'Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Danilycheva', 'Affiliation': 'National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia, Moscow, Russia.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Hide', 'Affiliation': 'Department of Dermatology, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Makris', 'Affiliation': 'Allergy Unit, 2nd Department of Dermatology and Venereology, National and Kapodistrian University, ""Attikon"" University Hospital, Athens, Greece.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Metz', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Sinisa', 'Initials': 'S', 'LastName': 'Savic', 'Affiliation': ""Leeds Biomedical Research Centre and Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), and Department of Clinical Immunology and Allergy, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Sitz', 'Affiliation': 'Little Rock Allergy and Asthma Clinic, Little Rock, AR, USA.'}, {'ForeName': 'Weily', 'Initials': 'W', 'LastName': 'Soong', 'Affiliation': 'Alabama Allergy & Asthma Center - AllerVie Health, Clinical Research Center of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Staubach', 'Affiliation': 'Department of Dermatology, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sussman', 'Affiliation': 'Division of Allergy and Clinical Immunology, University of Toronto, Canada.'}, {'ForeName': 'Avantika', 'Initials': 'A', 'LastName': 'Barve', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Alis', 'Initials': 'A', 'LastName': 'Burciu', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hua', 'Affiliation': 'China Novartis Institutes for Biomedical Research Co. Ltd, China.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Janocha', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Severin', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Allergy,['10.1111/all.15175']
3193,34773634,Comparison of Dapoxetine /Tadalafil and Paroxetine/Tadalafil Combination Therapies for the Treatment of the Premature Ejaculation: A Randomized Clinical Trial.,"PURPOSE


The purpose of this study was to compare the effectiveness of Dapoxetine, and Paroxetine as well as Dapoxetine/Tadalafil and Paroxetine/Tadalafil combinational therapies, for the treatment of patients with premature ejaculation.
MATERIALS AND METHODS


In this clinical trial study, 120 patients with premature ejaculation were randomly divided into 4 groups: The first group was treated with Paroxetine (Pa), while the second group received Dapoxetine(Da). The third group received Paroxetine combined with Tadalafil(PT) whereas the fourth group treatment involved the use of Dapoxetine and Tadalafil(DT) for one month. In the next 2 and 4 weeks, the cases were evaluated in terms of ejaculation duration, frequency of intercourse per week, and drug side effects.
RESULTS


The mean age of the Da, Pa, PT, DT groups was 32±6.9, 32.4±7.2, 31.6±1.9, and 32.9±7.7, respectively. There was a significant difference between the Da and DT groups (p = .029) in the ejaculation latency in the 4-week follow-up. In the two weeks follow-up, a significant difference was observed between DA and DT (p = 0.043), Pa and PT (p = 0.006), and Pa and DT groups (p= 0.004) in terms of ejaculation latency. Four weeks after the intervention, a significant difference was detected in the intercourse frequency of Da and PT groups (p =0.033), Pa and PT groups (p =0.043), Pa and DT groups (p =0.02), and Da and DT groups (p=0.016).
CONCLUSION


Combination therapy (Tadalafil plus Paroxetine or Dapoxetine) was more effective in IELT (Intra ejaculation latency time) than mono-therapy especially in younger patients despite its slightly more side effects.",2021,There was a significant difference between the Da and DT groups (p = .029) in the ejaculation latency in the 4-week follow-up.,"['Premature Ejaculation', 'patients with premature ejaculation', '120 patients with premature ejaculation']","['Dapoxetine /Tadalafil and Paroxetine/Tadalafil Combination Therapies', 'Dapoxetine/Tadalafil and Paroxetine/Tadalafil combinational therapies', 'Paroxetine (Pa), while the second group received Dapoxetine(Da', 'Combination therapy (Tadalafil plus Paroxetine or Dapoxetine', 'Dapoxetine, and Paroxetine', 'Dapoxetine and Tadalafil(DT', 'Paroxetine combined with Tadalafil(PT']","['intercourse frequency', 'ejaculation latency', 'ejaculation duration, frequency of intercourse per week, and drug side effects']","[{'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",120.0,0.0124704,There was a significant difference between the Da and DT groups (p = .029) in the ejaculation latency in the 4-week follow-up.,"[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohseni Rad', 'Affiliation': 'Department of Surgery, School of Medicine, Imam Reza Hospital, Ardabil University of Medical Sciences, Iran. sirhamed2@gmail.com.'}, {'ForeName': 'Telma', 'Initials': 'T', 'LastName': 'Zahirian Moghadam', 'Affiliation': 'Social Determinants of Health Research Center, Ardabil University of Medical Sciences, Iran. t.zahirian@gmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Department of Surgery, School of Medicine, Imam Reza Hospital, Ardabil University of Medical Sciences, Iran. drhosseinkhani@yahoo.com.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Nima Soluki', 'Affiliation': 'Department of Surgery, School of Medicine, Imam Reza Hospital, Ardabil University of Medical Sciences, Iran. nima.soluki@gmail.com.'}, {'ForeName': 'Firouz', 'Initials': 'F', 'LastName': 'Amani', 'Affiliation': 'School of Medicine, Ardabil University of Medical Sciences, Iran. firouz.amani@gmail.com.'}]",Urology journal,['10.22037/uj.v18i.6644']
3194,34772982,No effect of intradialytic neuromuscular electrical stimulation on inflammation and quality of life: a randomized and parallel design clinical trial.,"Neuromuscular electrical stimulation (NMES) elicits muscle contraction and has been shown to improvement of quality of life. However, if NMES improvement the quality of life and attenuate the inflammation is not fully understood. Therefore, our aim sought to assess the effects of short-term of intradialytic NMES on inflammation and quality of life in patients with chronic kidney disease patients undergoing hemodialysis. A randomized clinical trial conducted with parallel design enrolled adult hemodialysis patients three times a week during 1 month. Patients were randomly assigned to two groups (control group, n = 11; 4F/7 M) or (NMES group, n = 10; 4F/6 M). Pre-and post-intervention, was measured the high-sensitivity C reactive protein, interleukin-6, interleukin-10, and TNFα by the ELISA, and quality of life was applied using the SF-36. During each hemodialysis session, NMES was applied bilaterally at thigh and calves for 40 min. There was not change in cytokines (hs-CRP, IL-6, IL-10, and TNFα) concentrations time × group interaction. In addition, no difference was found in eight domains of quality of life. In addition, the groups did not differ for muscle strength and muscle mass. In conclusion, we found that intradialytic NMES did not change inflammation neither quality of life.",2021,"There was not change in cytokines (hs-CRP, IL-6, IL-10, and TNFα)",['patients with chronic kidney disease patients undergoing hemodialysis'],"['Neuromuscular electrical stimulation (NMES', 'NMES', 'intradialytic neuromuscular electrical stimulation', 'intradialytic NMES']","['quality of life', 'muscle strength and muscle mass', 'high-sensitivity C reactive protein, interleukin-6, interleukin-10, and TNFα by the ELISA, and quality of life', 'cytokines (hs-CRP, IL-6, IL-10, and TNFα', 'inflammation and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.113722,"There was not change in cytokines (hs-CRP, IL-6, IL-10, and TNFα)","[{'ForeName': 'Ana C B', 'Initials': 'ACB', 'LastName': 'Marini', 'Affiliation': 'Faculty of Nutrition, Federal University of Goias, Rua 227, Quadra 68 s/n°, Setor Leste Universitário, Goiânia, GO, CEP: 74605080, Brazil.'}, {'ForeName': 'Reika D', 'Initials': 'RD', 'LastName': 'Motobu', 'Affiliation': 'Faculty of Nutrition, Federal University of Goias, Rua 227, Quadra 68 s/n°, Setor Leste Universitário, Goiânia, GO, CEP: 74605080, Brazil.'}, {'ForeName': 'Patrícia C B', 'Initials': 'PCB', 'LastName': 'Lobo', 'Affiliation': 'Faculty of Nutrition, Federal University of Goias, Rua 227, Quadra 68 s/n°, Setor Leste Universitário, Goiânia, GO, CEP: 74605080, Brazil.'}, {'ForeName': 'Paula A', 'Initials': 'PA', 'LastName': 'Monteiro', 'Affiliation': 'Immunometabolism Research Group, Department of Physical Education, São Paulo State University, Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Faculty of Nutrition, Federal University of Goias, Rua 227, Quadra 68 s/n°, Setor Leste Universitário, Goiânia, GO, CEP: 74605080, Brazil. gupimentel@yahoo.com.br.'}]",Scientific reports,['10.1038/s41598-021-01498-7']
3195,34773384,Active cycle of breathing technique may reduce pulmonary complications after esophagectomy: A randomized clinical trial.,"BACKGROUND


The purpose of the study was to determine whether the active cycle of breathing technique (ACBT) has an impact on postoperative pulmonary complication (PPC) after esophagectomy.
METHODS


In this prospective randomized trial, patients who were candidates for esophagectomy were randomized into groups, wherein they received either ACBT (n = 146) or conventional chest physiotherapy (control group, n = 145) on postoperative days (POD) 1-3. The primary outcome was PPC. The secondary outcomes included the incidence of anastomotic leakage (AL), efficacy of airway clearance, and postoperative hospital length of stay (LOS).
RESULTS


After esophagectomy, the PPC rate was significantly lower in the ACBT group (15.2%) than in the control group (31.0%) (p = 0.001). The incidences of AL were 5.5% and 12.4% in the ACBT and control groups, respectively (p = 0.042). Mean hospital LOS was 12.3 days for the ACBT group and 16.8 days for the control group (p = 0.008). ACBT significantly increased the mean sputum wet weight (g) on POD 1-3 when compared with conventional therapy (POD 1 9.08 vs. 6.47, POD 2 16.86 vs. 10.92, POD 3 24.65 vs. 13.52, all p < 0.001). Multivariable analysis revealed that ACBT decreased the rates of PPC (odds ratio [OR] 0.403, p = 0.003), AL (OR 0.379，p = 0.038)，arrhythmia (OR 0.397, p = 0.028), and bronchoscopy aspiration (OR 0.362, p = 0.016).
CONCLUSION


ACBT is an effective airway clearance technique that significantly reduces the incidence of PPC after esophagectomy. ACBT could also significantly reduce both AL and LOS.",2021,"Multivariable analysis revealed that ACBT decreased the rates of PPC (odds ratio [OR] 0.403, p = 0.003), AL (OR 0.379，p = ",['patients who were candidates for esophagectomy'],"['breathing technique', 'breathing technique (ACBT', 'conventional chest physiotherapy (control group, n\xa0=\u2009145) on postoperative days (POD) 1-3', 'ACBT']","['incidence of anastomotic leakage (AL), efficacy of airway clearance, and postoperative hospital length of stay (LOS', 'PPC rate', 'AL and LOS', 'pulmonary complications', '0.038)，arrhythmia', 'mean sputum wet weight', 'Mean hospital LOS', 'postoperative pulmonary complication (PPC', 'incidences of AL', 'rates of PPC', 'PPC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0454503', 'cui_str': 'Active cycle of breathing technique'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.116142,"Multivariable analysis revealed that ACBT decreased the rates of PPC (odds ratio [OR] 0.403, p = 0.003), AL (OR 0.379，p = ","[{'ForeName': 'Jiudi', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Siwen', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Chuangzhen', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Weijin', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Zhangxian', 'Initials': 'Z', 'LastName': 'Hong', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Long', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Tiehua', 'Initials': 'T', 'LastName': 'Rong', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat Sen University Cancer Center, Guangzhou; State Key Laboratory of Oncology in Southern China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}]",Thoracic cancer,['10.1111/1759-7714.14227']
3196,34773355,"How does uterine contractile activity affect the success of trial of labour after caesarean section, and the risk of uterine rupture? An exploratory, blinded analysis of a cohort from a randomised controlled trial.","OBJECTIVE


To investigate the impact of uterine contractile activity on the outcome of trial of labour after caesarean section (TOLAC).
DESIGN


Secondary, blinded analyses of a prospective TOLAC cohort.
SETTING


Two labour wards, in a university tertiary hospital and a central hospital.
POPULATION


194 TOLAC parturients with intrauterine tocodynamometry during labour.
METHODS


Analysis of intrauterine pressure, frequency of contractions and baseline tonus of uterine muscle in 30-minute periods for four hours prior to birth.
MAIN OUTCOME MEASURES


Primary Outcome: uterine contractile activity during TOLAC. Secondary aims: contributors associated with failed TOLAC and uterine rupture.
RESULTS


TOLAC succeeded in 74% of cases. Uterine contractile activity, expressed as intrauterine pressure, was significantly higher in successful compared with failed TOLAC (210 vs 170 MVU). The statistically significant risk factors of failed TOLAC, after multivariate regression analysis, were prolonged gestational age, reduced cervical dilatation at admission, and lower mean intrauterine pressure. In cases of uterine rupture contractile activity did not differ from that in failed TOLAC. Cervical ripening with a Foley catheter appeared to be a risk factor of uterine rupture, as well as cervical dilatation < 3 cm at admission. The incidence of total uterine rupture was 2.6% (n=5).
CONCLUSIONS


Parturients with successful vaginal birth had higher uterine contractile activity than those experiencing failed TOLAC or uterine rupture despite similar use of oxytocin. Induction of labour with a Foley catheter turned out to be a risk factor of uterine rupture during TOLAC among parturients with no previous vaginal delivery.",2021,"Cervical ripening with a Foley catheter appeared to be a risk factor of uterine rupture, as well as cervical dilatation < 3 cm at admission.","['Parturients with successful vaginal birth', '194 TOLAC parturients with intrauterine tocodynamometry during labour', 'Two labour wards, in a university tertiary hospital and a central hospital', 'parturients with no previous vaginal delivery']","['TOLAC', 'oxytocin', 'Foley catheter', 'Cervical ripening with a Foley catheter']","['uterine contractile activity', 'intrauterine pressure', 'prolonged gestational age, reduced cervical dilatation at admission, and lower mean intrauterine pressure', 'intrauterine pressure, frequency of contractions and baseline tonus of uterine muscle', 'uterine rupture contractile activity', 'total uterine rupture', 'Uterine contractile activity']","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0040345', 'cui_str': 'Tocodynamometry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0233126', 'cui_str': 'Frequency of uterine contraction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027088', 'cui_str': 'Myometrial structure'}, {'cui': 'C0042143', 'cui_str': 'Rupture of uterus'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.238945,"Cervical ripening with a Foley catheter appeared to be a risk factor of uterine rupture, as well as cervical dilatation < 3 cm at admission.","[{'ForeName': 'Tuija Maria', 'Initials': 'TM', 'LastName': 'Hautakangas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Central Finland Health Care District, Delivery Ward, Jyväskylä, Finland.'}, {'ForeName': 'Jukka Tapio', 'Initials': 'JT', 'LastName': 'Uotila', 'Affiliation': 'Department of Obstetrics and Gynaecology, Tampere University Hospital, Faculty of Medicine and Health Technology, Tampere University, Finland.'}, {'ForeName': 'Heini Sa', 'Initials': 'HS', 'LastName': 'Huhtala', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Outi Liisa', 'Initials': 'OL', 'LastName': 'Palomäki', 'Affiliation': 'Department of Obstetrics and Gynaecology, Tampere University Hospital, Faculty of Medicine and Health Technology, Tampere University, Finland.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.17005']
3197,34773320,"Reply to Ghosh et al 1  . comments on Endoxifen: A new, protein kinase C inhibitor to treat acute and mixed mania associated with bipolar I disorder.","We reviewed Ghosh et al. letter based on our active-controlled, double-blind, and randomized trial that demonstrated the therapeutic benefit of Endoxifen in patients with bipolar I disorder.",2021,"letter based on our active-controlled, double-blind, and randomized trial that demonstrated the therapeutic benefit of Endoxifen in patients with bipolar I disorder.",['patients with bipolar I disorder'],['Endoxifen'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder'}]","[{'cui': 'C0048311', 'cui_str': '4-hydroxy-N-desmethyltamoxifen'}]",[],,0.221961,"letter based on our active-controlled, double-blind, and randomized trial that demonstrated the therapeutic benefit of Endoxifen in patients with bipolar I disorder.","[{'ForeName': 'Ateeq', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'Jina Pharmaceuticals Inc, Libertyville, Illinois, USA.'}, {'ForeName': 'Saifuddin', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Jina Pharmaceuticals Inc, Libertyville, Illinois, USA.'}, {'ForeName': 'Mujtaba Ali', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Intas Pharmaceuticals Ltd, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Chaturvedi', 'Affiliation': 'Intas Pharmaceuticals Ltd, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Piyush', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Intas Pharmaceuticals Ltd, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Lambda Therapeutic Research Ltd, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Bakul Chandrakant', 'Initials': 'BC', 'LastName': 'Buch', 'Affiliation': 'Shri Hatkesh Healthcare Foundation, Junagadh, Gujarat, India.'}, {'ForeName': 'Rajendra Someshwar', 'Initials': 'RS', 'LastName': 'Anand', 'Affiliation': 'Kanoria Hospital and Research Centre, Bhat, Gandhinagar, Gujarat, India.'}, {'ForeName': 'Timirkumar Chandrakant', 'Initials': 'TC', 'LastName': 'Shah', 'Affiliation': 'Divyam Hospital, Palsana, Surat, Gujarat, India.'}, {'ForeName': 'Vaishal Nareshchandra', 'Initials': 'VN', 'LastName': 'Vora', 'Affiliation': 'Ratandeep Multispecialty Hospital, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Vikhram', 'Initials': 'V', 'LastName': 'Ramasubramanian', 'Affiliation': 'Ahana Hospitals, Gandhinagar, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Satyanarayana', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'JSS Medical College Hospital, Mysore, Karnataka, India.'}, {'ForeName': 'Narendra', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Mysore Medical College and Research Institute, K.R. Hospital, Mysore, Karnataka, India.'}, {'ForeName': 'B S V', 'Initials': 'BSV', 'LastName': 'Prasad', 'Affiliation': 'Sujata Birla Hospital and Medical Research Center, Nasik, Maharashtra, India.'}, {'ForeName': 'Ramanathan', 'Initials': 'R', 'LastName': 'Sathianathan', 'Affiliation': 'Sri Ramachandra Medical College and Research Institute, Chennai Tamil Nadu, India.'}, {'ForeName': 'Kamal Kumar', 'Initials': 'KK', 'LastName': 'Verma', 'Affiliation': 'S.P. Medical College and A.G. Hospitals, Bikaner, Rajasthan, India.'}, {'ForeName': 'Venu Gopal', 'Initials': 'VG', 'LastName': 'Jhanwar', 'Affiliation': 'Deva Institute of Healthcare and Research, Uttar Pradesh, Varanasi, India.'}, {'ForeName': 'Nand', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Gujarat Medical Education & Research Society Medical College, Gotri, Vadodara, India.'}, {'ForeName': 'Pronob Kumar', 'Initials': 'PK', 'LastName': 'Dalal', 'Affiliation': ""King George's Medical University, G.M. Associated Hospitals, Uttar Pradesh, Lucknow, India.""}, {'ForeName': 'Brahmdeep', 'Initials': 'B', 'LastName': 'Sindhu', 'Affiliation': 'Civil Hospital, Gurugram, Haryana, India.'}, {'ForeName': 'Payel', 'Initials': 'P', 'LastName': 'Talukdar', 'Affiliation': 'Nil Ratan Sircar Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Jina Pharmaceuticals Inc, Libertyville, Illinois, USA.'}]",Bipolar disorders,['10.1111/bdi.13151']
3198,34773446,Radiomic Analysis of Pharmacokinetic Heterogeneity Within Tumor Based on the Unsupervised Decomposition of Dynamic Contrast-Enhanced MRI for Predicting Histological Characteristics of Breast Cancer.,"BACKGROUND


Breast tumor heterogeneity is associated with histological characteristics. However, pharmacokinetic (PK) heterogeneity within tumor might merit further exploration.
PURPOSE


To enhance the predictive power of molecular subtypes, Ki-67, and tumor grade by analyzing PK heterogeneity within tumor based on dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
STUDY TYPE


Retrospective.
POPULATION


Two hundred and eight biopsy-proven breast cancer patients, randomly divided into a training cohort (N = 144) and a testing cohort (N = 64).
FIELD STRENGTH/SEQUENCE


T 1  -weighted DCE-MRI at 3.0 T.
ASSESSMENT


A convex analysis of mixtures-compartmental modeling decomposition method was used to estimate the PK parameter (i.e., the volume transfer constant K trans  ) in tumor subregions with distinct physiological kinetic patterns, including fast-flow kinetics, slow-flow kinetics, and plasma input. Radiomic features based on the PK parameter were calculated from each tumor subregion.
STATISTICAL TESTS


The training cohort was used to build random forest classifiers based on the optimal features determined by the 5-fold cross-validation method. The performance was assessed on the testing cohort using the area under the receiver operating characteristic curve (AUC). The AUCs derived from the tumor subregion-based PK parameter were compared with those of the original images of the entire tumor using the DeLong test. A P-value of <0.05 was considered statistically significant.
RESULTS


The tumor subregion-based PK parameter, which yielded the highest AUCs of 0.8782, 0.7568, 0.7019, 0.7963, 0.8080, and 0.7375 for luminal A, luminal B, basal-like, human epidermal growth factor receptor 2, Ki-67, and tumor grade, respectively, obtained better diagnostic performance than the original images in the entire tumor (highest AUCs = 0.8612, 0.6191, 0.5593, 0.7704, 0.7494, and 0.6261, respectively). In particular, statistically significant improvement in the diagnostic performance was obtained for luminal B.
DATA CONCLUSION


Radiomic analysis of PK heterogeneity within tumor can enhance the predictive performance of radiomic models compared with that of the entire tumor.
LEVEL OF EVIDENCE


4 TECHNICAL EFFICACY STAGE: 3.",2021,"In particular, statistically significant improvement in the diagnostic performance was obtained for luminal B.
DATA CONCLUSION


Radiomic analysis of PK heterogeneity within tumor can enhance the predictive performance of radiomic models compared with that of the entire tumor.
",['Two hundred and eight biopsy-proven breast cancer patients'],['Unsupervised Decomposition of Dynamic Contrast-Enhanced MRI'],['diagnostic performance'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.0209887,"In particular, statistically significant improvement in the diagnostic performance was obtained for luminal B.
DATA CONCLUSION


Radiomic analysis of PK heterogeneity within tumor can enhance the predictive performance of radiomic models compared with that of the entire tumor.
","[{'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Computer Science and Technology, Hangzhou Dianzi University, Hangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': 'Institute of Biomedical Engineering and Instrumentation, School of Automation, Hangzhou Dianzi University, Hangzhou, China.'}, {'ForeName': 'Shiwei', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Maosheng', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'School of Computer Science and Technology, Hangzhou Dianzi University, Hangzhou, China.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27993']
3199,34773438,Reinforcing the effect of microsurgery practice during robotic suturing skill acquisition.,"BACKGROUND


This study aimed to examine the effectiveness of microsurgery practice during an interval in robotic surgical training.
METHODS


Two participant groups with 30 trainees each practiced Thread the Rings 1 on a dV-Trainer. There were four 2-h training sessions, with a 72-h interval between each session. Group A received no additional training during the study period. During every interval, Group B practiced a similar 2-h ring penetration exercise using a microscope three times (once every 24 h).
RESULTS


The 72-h delay between two sessions for Group A caused the forgetting effect. For Group B, additional microscope-based training aided memory retention. After the training session, Group B presented a significantly higher score than Group A in Thread the Ring 1 learning curves.
CONCLUSIONS


Adding microsurgical skill training into the basic robotic-surgery training curriculum could be helpful because additional trainings with a binocular microscope could improve robotic surgical skill levels. This article is protected by copyright. All rights reserved.",2021,"After the training session, Group B presented a significantly higher score than Group A in Thread the Ring 1 learning curves.
",['Two participant groups with 30 trainees each practiced Thread the Rings 1 on a dV-Trainer'],[],"['robotic surgical skill levels', 'forgetting effect']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}]",[],"[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.019095,"After the training session, Group B presented a significantly higher score than Group A in Thread the Ring 1 learning curves.
","[{'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Wuhan University, Zhongnan Hospital, Wuhan, 430071, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Wuhan University, Zhongnan Hospital, Wuhan, 430071, China.'}, {'ForeName': 'Xinghuan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Wuhan University, Zhongnan Hospital, Wuhan, 430071, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lei', 'Affiliation': 'Wuhan University, Zhongnan Hospital, Wuhan, 430071, China.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Wuhan University, Zhongnan Hospital, Wuhan, 430071, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Wuhan University, Zhongnan Hospital, Wuhan, 430071, China.'}]",The international journal of medical robotics + computer assisted surgery : MRCAS,['10.1002/rcs.2350']
3200,34773428,EEG power spectral responses to wind farm compared with road traffic noise during sleep: A laboratory study.,"Wind turbine noise is dominated by low frequencies for which effects on sleep relative to more common environmental noise sources such as road traffic noise remain unknown. This study examined the effect of wind turbine noise compared with road traffic noise on sleep using quantitative electroencephalogram power spectral analysis. Twenty-three participants were exposed to 3-min samples of wind turbine noise and road traffic noise at three sound pressure levels (33, 38 and 43 dBA) in randomised order during established sleep. Acute (0-30 s) and more sustained (30-180 s) effects of noise presentations during N2 and N3 sleep were examined using spectral analysis of changes in electroencephalogram power frequency ranges across time in 5-s intervals. Both noise types produced time- and sound pressure level-dependent increases in electroencephalogram power, but with significant noise type by sound pressure level interactions in beta, alpha, theta and delta frequency bands (all p < 0.05). Wind turbine noise showed significantly lower delta, theta and beta activity immediately following noise onset compared with road traffic noise (all p < 0.05). However, alpha activity was higher for wind turbine noise played at lower sound pressure levels (33 dBA [p = 0.001] and 38 dBA [p = 0.003]) compared with traffic noise during N2 sleep. These findings support that spectral analyses show subtle effects of noise on sleep and that electroencephalogram changes following wind turbine noise and road traffic noise onset differ depending on sound pressure levels; however, these effects were mostly transient and had little impact on conventionally scored sleep. Further studies are needed to establish if electroencephalogram changes associated with modest environmental noise exposures have significant impacts on sleep quality and next-day functioning.",2021,"Wind turbine noise showed significantly lower delta, theta and beta activity immediately following noise onset compared with road traffic noise (all p < 0.05).",[],['wind turbine noise compared with road traffic noise'],"['time- and sound pressure level', 'sound pressure levels', 'delta, theta and beta activity', 'alpha activity']",[],"[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0442650', 'cui_str': 'Road'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",23.0,0.0498999,"Wind turbine noise showed significantly lower delta, theta and beta activity immediately following noise onset compared with road traffic noise (all p < 0.05).","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dunbar', 'Affiliation': 'College of Education, Psychology and Social Work, Flinders University of South Australia, Bedford Park, SA, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Catcheside', 'Affiliation': 'Flinders Health and Medical Research Institute: Sleep Health (formerly Adelaide Institute for Sleep Health), College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Lechat', 'Affiliation': 'Flinders Health and Medical Research Institute: Sleep Health (formerly Adelaide Institute for Sleep Health), College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Hansen', 'Affiliation': 'College of Engineering, Flinders University of South Australia, Bedford Park, SA, Australia.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Zajamsek', 'Affiliation': 'Flinders Health and Medical Research Institute: Sleep Health (formerly Adelaide Institute for Sleep Health), College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Liebich', 'Affiliation': 'College of Education, Psychology and Social Work, Flinders University of South Australia, Bedford Park, SA, Australia.'}, {'ForeName': 'Duc Phuc', 'Initials': 'DP', 'LastName': 'Nguyen', 'Affiliation': 'College of Engineering, Flinders University of South Australia, Bedford Park, SA, Australia.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Scott', 'Affiliation': 'Flinders Health and Medical Research Institute: Sleep Health (formerly Adelaide Institute for Sleep Health), College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Lack', 'Affiliation': 'Flinders Health and Medical Research Institute: Sleep Health (formerly Adelaide Institute for Sleep Health), College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Decup', 'Affiliation': 'College of Engineering, Flinders University of South Australia, Bedford Park, SA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vakulin', 'Affiliation': 'Flinders Health and Medical Research Institute: Sleep Health (formerly Adelaide Institute for Sleep Health), College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Gorica', 'Initials': 'G', 'LastName': 'Micic', 'Affiliation': 'Flinders Health and Medical Research Institute: Sleep Health (formerly Adelaide Institute for Sleep Health), College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}]",Journal of sleep research,['10.1111/jsr.13517']
3201,33514817,A multilayer multimodal detection and prediction model based on explainable artificial intelligence for Alzheimer's disease.,"Alzheimer's disease (AD) is the most common type of dementia. Its diagnosis and progression detection have been intensively studied. Nevertheless, research studies often have little effect on clinical practice mainly due to the following reasons: (1) Most studies depend mainly on a single modality, especially neuroimaging; (2) diagnosis and progression detection are usually studied separately as two independent problems; and (3) current studies concentrate mainly on optimizing the performance of complex machine learning models, while disregarding their explainability. As a result, physicians struggle to interpret these models, and feel it is hard to trust them. In this paper, we carefully develop an accurate and interpretable AD diagnosis and progression detection model. This model provides physicians with accurate decisions along with a set of explanations for every decision. Specifically, the model integrates 11 modalities of 1048 subjects from the Alzheimer's Disease Neuroimaging Initiative (ADNI) real-world dataset: 294 cognitively normal, 254 stable mild cognitive impairment (MCI), 232 progressive MCI, and 268 AD. It is actually a two-layer model with random forest (RF) as classifier algorithm. In the first layer, the model carries out a multi-class classification for the early diagnosis of AD patients. In the second layer, the model applies binary classification to detect possible MCI-to-AD progression within three years from a baseline diagnosis. The performance of the model is optimized with key markers selected from a large set of biological and clinical measures. Regarding explainability, we provide, for each layer, global and instance-based explanations of the RF classifier by using the SHapley Additive exPlanations (SHAP) feature attribution framework. In addition, we implement 22 explainers based on decision trees and fuzzy rule-based systems to provide complementary justifications for every RF decision in each layer. Furthermore, these explanations are represented in natural language form to help physicians understand the predictions. The designed model achieves a cross-validation accuracy of 93.95% and an F1-score of 93.94% in the first layer, while it achieves a cross-validation accuracy of 87.08% and an F1-Score of 87.09% in the second layer. The resulting system is not only accurate, but also trustworthy, accountable, and medically applicable, thanks to the provided explanations which are broadly consistent with each other and with the AD medical literature. The proposed system can help to enhance the clinical understanding of AD diagnosis and progression processes by providing detailed insights into the effect of different modalities on the disease risk.",2021,"The resulting system is not only accurate, but also trustworthy, accountable, and medically applicable, thanks to the provided explanations which are broadly consistent with each other and with the AD medical literature.","[""Alzheimer's disease (AD"", 'real-world dataset', ""1048 subjects from the Alzheimer's Disease Neuroimaging Initiative (ADNI"", '294 cognitively normal, 254 stable mild cognitive impairment (MCI), 232 progressive MCI, and 268 AD', ""Alzheimer's disease""]",[],[],"[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4517673', 'cui_str': '268'}]",[],[],1048.0,0.154676,"The resulting system is not only accurate, but also trustworthy, accountable, and medically applicable, thanks to the provided explanations which are broadly consistent with each other and with the AD medical literature.","[{'ForeName': 'Shaker', 'Initials': 'S', 'LastName': 'El-Sappagh', 'Affiliation': 'Centro Singular de Investigación en Tecnoloxías Intelixentes (CiTIUS), Universidade de Santiago de Compostela, 15782, Santiago de Compostela, Spain. shaker.elsappagh@usc.es.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Alonso', 'Affiliation': 'Centro Singular de Investigación en Tecnoloxías Intelixentes, Universidade de Santiago de Compostela, 15703, Santiago, Spain.'}, {'ForeName': 'S M Riazul', 'Initials': 'SMR', 'LastName': 'Islam', 'Affiliation': 'Department of Computer Science and Engineering, Sejong University, 209 Neungdong-ro, Gwangjin-gu, Seoul, 05006, Korea.'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Sultan', 'Affiliation': 'Gastrointestinal Surgical Center, Faculty of Medicine, Mansoura University, Mansura, 35516, Egypt.'}, {'ForeName': 'Kyung Sup', 'Initials': 'KS', 'LastName': 'Kwak', 'Affiliation': 'Department of Information and Communication Engineering, Inha University, Incheon, 22212, South Korea. kskwak@inha.ac.kr.'}]",Scientific reports,['10.1038/s41598-021-82098-3']
3202,33863454,Effectiveness and safety of a thermal insulating coverage on the top of the cryo-cabin during a partial-body cryostimulation.,"Partial Body Cryostimulation (PBC) consists of exposing minimally dressed participants to very cold air, in a specially designed cabin (cryo-cabin), for a short period of time. In recent years, cryo-cabins have been launched with a coverage to limit thermo-dispersion, however a validation study is lacking. The aim of this study was to compare thermal responses after a PBC protocol in an open cryo-cabin or into a cryo-cabin closed at the top with a polyurethane-made lid. Eighteen young male adults completed the two 150 s PBC sessions in a cross-over fashion. Temperature of the inner cabin and thermal responses were measured prior and 1, 5, 10, 20 min after completing each PBC session. When covered, cryo-cabins maintained a lower temperature in the front with respect to the back. There was a significant interaction regarding coverage*time*position with a main effect of coverage. Body surfaces were significantly colder under covered condition compared to open PBC. Subjects perceived a greater thermal discomfort during a covered PBC rather than during an open condition. For the first time, the use of a coverage placed on the top of the cabin was demonstrated to maintain lower temperatures of the inner environment and the users' skin with respect to a standard PBC. This evidence indicates that practitioners and clinicians making use of PBC can successfully and safely cover cryo-cabins with an insulating lid so to improve the effectiveness of their treatments.",2021,Body surfaces were significantly colder under covered condition compared to open PBC.,['Eighteen young male adults'],[],"['Partial Body Cryostimulation (PBC', 'Body surfaces', 'Effectiveness and safety', 'thermal discomfort']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",18.0,0.00892133,Body surfaces were significantly colder under covered condition compared to open PBC.,"[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'De Nardi', 'Affiliation': 'Krioplanet Ltd, Treviglio, Bergamo, Italy; Department of Experimental Medicine, Università degli Studi di Genova, Genoa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Silvani', 'Affiliation': 'Krioplanet Ltd, Treviglio, Bergamo, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Facheris', 'Affiliation': 'Krioplanet Ltd, Treviglio, Bergamo, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pagnoncelli', 'Affiliation': 'Krioplanet Ltd, Treviglio, Bergamo, Italy.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Bisio', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, Genoa, Italy; Centro Polifunzionale di Scienze Motorie, Università degli Studi di Genova, Genoa, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Faelli', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, Genoa, Italy; Centro Polifunzionale di Scienze Motorie, Università degli Studi di Genova, Genoa, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'La Torre', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy; IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Ruggeri', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, Genoa, Italy; Centro Polifunzionale di Scienze Motorie, Università degli Studi di Genova, Genoa, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Codella', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy; Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Milan, Italy. Electronic address: roberto.codella@unimi.it.'}]",Journal of thermal biology,['10.1016/j.jtherbio.2021.102901']
3203,34773928,Temporal dynamics of symptom change among veterans receiving an integrated treatment for posttraumatic stress disorder and substance use disorders.,"The present study examined temporal patterns of symptom change during treatment for comorbid posttraumatic stress disorders (PTSD) and substance use disorders (SUDs). We hypothesized that PTSD symptom severity would predict subsequent-session substance use and that this association would be particularly strong among patients who received an integrated treatment versus SUD-only treatment. Participants were 81 United States military veterans with current PTSD and an SUD who were enrolled in a 12-week, randomized controlled trial examining the efficacy of an integrated treatment called Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) compared with cognitive behavioral relapse prevention therapy (RP). Lagged multilevel models indicated that PTSD symptom improvement did not significantly predict the likelihood of next-session substance use (likelihood of use: B = 0.03, SE = 0.02, p = .141; percentage of days using B = -0.02, SE = 0.01, p = .172. Neither substance use, B = 1.53, SE = 1.79, p = .391, nor frequency of use, B = 0.26, SE = 0.50, p = .612, predicted next-session PTSD symptom severity in either treatment condition. Stronger associations between PTSD symptoms and next-session substance use were expected given the self-medication hypothesis. Additional research is needed to better understand the temporal dynamics of symptom change as well as the specific mediators and mechanisms underlying symptom change.",2021,"Neither substance use, B = 1.53, SE = 1.79, p = .391, nor frequency of use, B = 0.26, SE = 0.50, p = .612, predicted next-session PTSD symptom severity in either treatment condition.","['Participants were 81 United States military veterans with current PTSD and an SUD who were enrolled', 'veterans receiving an integrated treatment for posttraumatic stress disorder and substance use disorders', 'comorbid posttraumatic stress disorders (PTSD) and substance use disorders (SUDs']","['integrated treatment called Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE', 'cognitive behavioral relapse prevention therapy (RP']","['next-session PTSD symptom severity', 'PTSD symptom improvement', 'likelihood of next-session substance use']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",81.0,0.0269174,"Neither substance use, B = 1.53, SE = 1.79, p = .391, nor frequency of use, B = 0.26, SE = 0.50, p = .612, predicted next-session PTSD symptom severity in either treatment condition.","[{'ForeName': 'Christal L', 'Initials': 'CL', 'LastName': 'Badour', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Allan', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Gilmore', 'Affiliation': 'Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Gros', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Kristina J', 'Initials': 'KJ', 'LastName': 'Korte', 'Affiliation': 'Psychiatry Department, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Kateryna', 'Initials': 'K', 'LastName': 'Kolnogorova', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}]",Journal of traumatic stress,['10.1002/jts.22769']
3204,34773923,"A Randomized Study of the Safety and Pharmacokinetics of GSK3358699, a Mononuclear Myeloid-Targeted Bromodomain and Extra-Terminal Domain Inhibitor.","AIMS


GSK3358699 is a mononuclear myeloid-targeted bromodomain and extra-terminal domain (BET) family inhibitor which demonstrates immunomodulatory effects in vitro. This phase 1, randomized, first-in-human study evaluated the safety, pharmacokinetics, and pharmacodynamics of GSK3358699 in healthy male participants (NCT03426995).
METHODS


Part A (N=23) included three dose-escalating periods of 1-40 mg GSK3358699 or placebo in two cohorts in a single ascending-dose crossover design. Part C (N=25) was planned as an initial dose of 10 mg GSK3358699 or placebo daily for 14 days followed by selected doses in four sequential cohorts.
RESULTS


In part A, exposure to GSK3358699 and its metabolite GSK3206944 generally increased with increasing doses. The median initial half-life ranged from 0.7-1.1 (GSK3358699) and 2.1-2.9 (GSK3206944) hours after a single dose of 1-40 mg. GSK3206944 concentrations in monocytes were quantifiable at 1-hour post-dose following 10 mg GSK3358699 and 1 and 4 hours post-dose following 20-40 mg. Mean predicted percent inhibition of ex vivo lipopolysaccharide (LPS)-induced MCP-1 reached 75% with 40 mg GSK3358699. GSK3358699 did not inhibit IL-6 and TNF. The most common adverse event (AE) was headache. Four AEs of non-sustained ventricular tachycardia were observed across parts A and C. One serious AE of atrial fibrillation (part C) required hospitalization.
CONCLUSIONS


Single doses of GSK3358699 are generally well tolerated with significant metabolite concentrations detected in target cells. A complete assessment of pharmacodynamics was limited by assay variability. A causal relationship could not be excluded for cardiac-related AEs, resulting in an inability to identify a suitable repeat-dose regimen and study termination.",2021,GSK3358699 did not inhibit IL-6 and TNF.,['healthy male participants (NCT03426995'],"['GSK3358699', 'GSK3358699 or placebo']","['median initial half-life', 'safety, pharmacokinetics, and pharmacodynamics', 'inhibition of ex vivo lipopolysaccharide (LPS)-induced MCP-1']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}]",,0.0872162,GSK3358699 did not inhibit IL-6 and TNF.,"[{'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Brown', 'Affiliation': 'GlaxoSmithKline R&D, Cambridge, MA, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Bal', 'Affiliation': 'GlaxoSmithKline R&D Stevenage, Stevenage, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Simeoni', 'Affiliation': 'GlaxoSmithKline, GSK House, Brentford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'GlaxoSmithKline, GSK House, Brentford, UK.'}, {'ForeName': 'Palwinder K', 'Initials': 'PK', 'LastName': 'Mander', 'Affiliation': 'GlaxoSmithKline R&D Stevenage, Stevenage, UK.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Soden', 'Affiliation': 'GlaxoSmithKline R&D Stevenage, Stevenage, UK.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Daga', 'Affiliation': 'GlaxoSmithKline, West Drayton, Uxbridge, UK.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Fahy', 'Affiliation': 'GlaxoSmithKline, GSK House, Brentford, UK.'}, {'ForeName': 'Gabriel K', 'Initials': 'GK', 'LastName': 'Wong', 'Affiliation': 'GlaxoSmithKline R&D Stevenage, Stevenage, UK.'}, {'ForeName': 'Jackie C', 'Initials': 'JC', 'LastName': 'Bloomer', 'Affiliation': 'GlaxoSmithKline R&D, Ware, Hertfordshire, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Erwig', 'Affiliation': 'GlaxoSmithKline R&D Stevenage, Stevenage, UK.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'GlaxoSmithKline, GSK House, Brentford, UK.'}, {'ForeName': 'Disala', 'Initials': 'D', 'LastName': 'Fernando', 'Affiliation': ""GlaxoSmithKline R&D Clinical Unit, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Carnaghan', 'Affiliation': ""GlaxoSmithKline R&D Clinical Unit, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Banham-Hall', 'Affiliation': ""GlaxoSmithKline R&D Clinical Unit, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hopkins', 'Affiliation': ""GlaxoSmithKline R&D Clinical Unit, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': ""GlaxoSmithKline R&D Clinical Unit, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Joao J', 'Initials': 'JJ', 'LastName': 'Oliveira', 'Affiliation': ""GlaxoSmithKline R&D Clinical Unit, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Rab K', 'Initials': 'RK', 'LastName': 'Prinjha', 'Affiliation': 'GlaxoSmithKline R&D Stevenage, Stevenage, UK.'}]",British journal of clinical pharmacology,['10.1111/bcp.15137']
3205,34773884,Testing the validity of the AUDIT-C and AUDIT-3 to detect unhealthy alcohol use among high-risk populations in Zambia: A secondary analysis from two randomized trials.,"BACKGROUND


This study evaluated the test characteristics of brief versions of the Alcohol Use Disorders Identification Test (AUDIT), the AUDIT-C and AUDIT-3, compared to the full AUDIT in populations with heavy drinking living in Zambia and compared differences in effect size estimates when using brief versions in clinical trials.
METHODS


Data were obtained from two randomized trials of the Common Elements Treatment Approach (CETA) for reducing unhealthy alcohol use among adult couples and people living with HIV (PLWH) in Zambia. The full AUDIT was administered to participants at baseline and at 6- or 12-month follow-up. Sensitivity and specificity of the brief versions were calculated in comparison to the full AUDIT. Mixed effects regression models were estimated to calculate the effect sizes from the trials using the brief versions and these were compared to the originally calculated effect sizes using the full version.
RESULTS


The AUDIT-C performed well at cut-off ≥ 3 for both men (sensitivity: >80%; specificity: >76%) and women (sensitivity: >84%; specificity: >88%). The AUDIT-3 performed best at cut-off ≥ 1, but with comparatively reduced validity for men (sensitivity: >77%; specificity: ≥60%) and women (sensitivity: ≥72%; specificity: >62%). Effect sizes were different by up to 52% using the AUDIT-C and up to 60% for the AUDIT-3 compared to the AUDIT.
CONCLUSIONS


The AUDIT-C is recommended as a brief screening tool for community-based and clinic-based screening in Zambia among populations with high prevalence of unhealthy alcohol use. For research studies, the full AUDIT is recommended to calculate treatment effect.",2021,The AUDIT-C performed well at cut-off ≥ 3 for both men (sensitivity: >80%; specificity: >76%) and women (sensitivity: >84%; specificity: >88%).,"['adult couples and people living with HIV (PLWH) in Zambia', 'high-risk populations in Zambia', 'populations with heavy drinking living in Zambia', 'community-based and clinic-based screening in Zambia among populations with high prevalence of unhealthy alcohol use']",['Common Elements Treatment Approach (CETA) for reducing unhealthy alcohol use'],['Sensitivity and specificity'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",,0.0582485,The AUDIT-C performed well at cut-off ≥ 3 for both men (sensitivity: >80%; specificity: >76%) and women (sensitivity: >84%; specificity: >88%).,"[{'ForeName': 'Sachi', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY, USA. Electronic address: sachi_inoue@hsph.harvard.edu.'}, {'ForeName': 'Chipo', 'Initials': 'C', 'LastName': 'Chitambi', 'Affiliation': 'Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Vinikoor', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'Tukiya', 'Initials': 'T', 'LastName': 'Kanguya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Mwamba M', 'Initials': 'MM', 'LastName': 'Mwenge', 'Affiliation': 'Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.'}, {'ForeName': 'Saphira', 'Initials': 'S', 'LastName': 'Munthali', 'Affiliation': 'Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.'}, {'ForeName': 'Jeremy C', 'Initials': 'JC', 'LastName': 'Kane', 'Affiliation': 'Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109156']
3206,34773880,Parasacral versus tibial transcutaneous electrical stimulation to treat urinary urgency in adult women: Randomized controlled clinical trial.,"INTRODUCTION


Urinary urgency is a very strong urge to urinate that is difficult to postpone and control. One of the physiotherapeutic resources that can be used in the treatment of urinary urgency is electrical nerve stimulation. The objective of this study is to investigate the effects of parasacral and tibial nerve transcutaneous electrical stimulation in improving urinary urgency in adult women.
MATERIAL AND METHODS


Single-blinded randomized controlled clinical trial.
PARTICIPANTS


Ninety-nine adult women with urgency.
INTERVENTIONS


Transcutaneous electrostimulation for 12, 20-min sessions, twice a week. The tibial and parasacral groups received a current of F = 10 Hz and 200 μs pulse duration, while the sham group received a current of F = 100 Hz and 100 μs pulse duration, the active electrode placed over the scapula. Primary and secondary outcome measures: The primary outcome measure was urinary urgency, measured by the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) and Overactive Bladder questionnaire-Validated 8-Question Awareness Tool (OAB-V8). Secondary outcomes were quality of life with the King's Health Questionnaire (KHQ) and voiding habits with the 24-h voiding diary. Assessments occurred pretreatment, after the sixth and 12th post-treatment sessions and at the 30-day follow-up.
RESULTS


Both parasacral and tibial groups in the post-treatment presented fewer episodes of urgency than the sham group. The parasacral group showed better results than the sham group post-treatment for ICIQ-OAB scores, and in KHQ domains Impact of Incontinence and task limitations. Parasacral group participants had OAB-V8 score lower than 8 in the post-treatment and follow-up.
CONCLUSION


Both tibial and parasacral groups had a positive and similar effect on reducing urinary urgency in adult women. Relative to the quality of life, transcutaneous parasacral electrostimulation was superior to transcutaneous tibial electrostimulation.
CLINICAL TRIAL REGISTRATION


Brazilian Registry of Clinical Trials (ReBEC), http://ensaiosclinicos.gov.br, protocol RBR-9rf33n.",2021,"The parasacral group showed better results than the sham group post-treatment for ICIQ-OAB scores, and in KHQ domains Impact of Incontinence and task limitations.","['Ninety-nine adult women with urgency', 'adult women']","['parasacral and tibial nerve transcutaneous electrical stimulation', 'current of F\xa0', 'Parasacral versus tibial transcutaneous electrical stimulation', 'Transcutaneous electrostimulation']","['urinary urgency, measured by the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) and Overactive Bladder questionnaire-Validated 8-Question Awareness Tool (OAB-V8', 'urinary urgency', 'episodes of urgency', ""quality of life with the King's Health Questionnaire (KHQ) and voiding habits with the 24-h voiding diary"", 'ICIQ-OAB scores', 'OAB-V8 score']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}]","[{'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",99.0,0.291675,"The parasacral group showed better results than the sham group post-treatment for ICIQ-OAB scores, and in KHQ domains Impact of Incontinence and task limitations.","[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Falcão Padilha', 'Affiliation': ""Physical Therapy Post-Graduate Program, Universidade Federal de São Carlos (UFSCar), São Carlos, SP, Brazil; Laboratory of Research on Women's Health (LAMU), UFSCar, São Carlos, SP, Brazil. Electronic address: jufpadilha@gmail.com.""}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Arias Avila', 'Affiliation': 'Physical Therapy Post-Graduate Program, Universidade Federal de São Carlos (UFSCar), São Carlos, SP, Brazil; Laboratory of Research on Electrophysical Agents (LAREF), Physical Therapy Department, UFSCar, São Carlos, SP, Brazil. Electronic address: m.avila@ufscar.br.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': ""Physical Therapy Post-Graduate Program, Universidade Federal de São Carlos (UFSCar), São Carlos, SP, Brazil; Laboratory of Research on Women's Health (LAMU), UFSCar, São Carlos, SP, Brazil. Electronic address: pdriusso@ufscar.br.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2021.10.025']
3207,34773870,"Corrigendum to ""Perioperative supplemental oxygen and NT-proBNP concentrations after major abdominal surgery - A prospective randomized clinical trial"" [Journal of Clinical Anaesthesia volume 73 (2021) article 110379].",,2021,,[],[],[],[],[],[],,0.183884,,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reiterer', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kabon', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria. Electronic address: barbara.kabon@meduniwien.ac.at.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Taschner', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Markus Falkner', 'Initials': 'MF', 'LastName': 'von Sonnenburg', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Graf', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Adamowitsch', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Starlinger', 'Affiliation': 'Department of Surgery, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Goschin', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Fraunschiel', 'Affiliation': 'IT Systems and Communications, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110579']
3208,34773794,Tipifarnib as maintenance therapy did not improve disease-free survival in patients with acute myelogenous leukemia at high risk of relapse: Results of the phase III randomized E2902 trial.,"PURPOSE


Despite the achievement of complete remission with chemotherapy in patients with acute myeloid leukemia (AML), relapse is common and the majority of patients will die of their disease. Patients who achieve a remission after refractory or relapsed disease as well as elderly patients have a very high rate of relapse even if they achieve a complete remission. A phase 3 randomized ECOG-ACRIN-led intergroup study was conducted to determine whether post-remission therapy with the farnesyl transferase inhibitor, tipifarnib (R115777), improved the disease-free survival (DFS) of adult patients with AML in complete remission (CR), at high risk for relapse.
PATIENTS AND METHODS


Adult patients with AML in remission after salvage therapy and/or over age 60 in first remission were enrolled in this study. They were randomly assigned to treatment with tipifarnib or observation (control). The primary objective was to compare the disease-free survival (DFS) between the two arms based on intention to treat, which includes all randomized patients.
RESULTS


One hundred and forty-four patients were enrolled on the study. Median DFS was 8.9 vs 5.3 months, for tipifarnib vs observation (one-sided p = 0.026) and did not cross the pre-specified boundary to call the study positive. For the 134 eligible patients, median DFS was 10.8 vs 5.3 months for those randomized to tipifarnib vs observation (one-sided p = 0.008). Moreover in an ad hoc evaluation of all women (n = 71) median DFS was 12.1 vs 3.9 months for tipifarnib vs observation (one-sided p = 0.0004) while median OS was 26.5 vs 8.4 months respectively (one-sided p = 0.001).
CONCLUSION


This study was not able to demonstrate a benefit to tipifarnib as maintenance therapy in patients with AML in remission. While subsets of patients may indeed benefit, additional studies would be needed to elucidate that benefit which is unlikely given that other seemingly better options have since become available.",2021,"Median DFS was 8.9 vs 5.3 months, for tipifarnib vs observation","['One hundred and forty-four patients were enrolled on the study', 'patients with AML in remission', 'Adult patients with AML in remission after salvage therapy and/or over age 60 in first remission were enrolled in this study', 'patients with acute myelogenous leukemia at high risk of relapse', 'patients with acute myeloid leukemia (AML', 'adult patients with AML in complete remission (CR), at high risk for relapse']","['tipifarnib', 'tipifarnib vs observation', 'farnesyl transferase inhibitor, tipifarnib (R115777', 'Tipifarnib', 'chemotherapy', 'tipifarnib or observation (control']","['disease-free survival', 'median OS', 'disease-free survival (DFS', 'median DFS', 'Median DFS']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0153886', 'cui_str': 'Acute myeloid leukemia in remission'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]","[{'cui': 'C1176289', 'cui_str': 'tipifarnib'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0138837', 'cui_str': 'protein farnesyltransferase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0393031', 'cui_str': 'R115777'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",144.0,0.178003,"Median DFS was 8.9 vs 5.3 months, for tipifarnib vs observation","[{'ForeName': 'Selina M', 'Initials': 'SM', 'LastName': 'Luger', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Perelman Center for Advanced Medicine, South Tower, 12th Floor, Philadelphia, PA, PA 19104, United States. Electronic address: Selina.luger@pennmedicine.upenn.edu.'}, {'ForeName': 'Victoria X', 'Initials': 'VX', 'LastName': 'Wang', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, AMA, United States.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Rowe', 'Affiliation': 'Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Litzow', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Paietta', 'Affiliation': 'Montefiore Medical Center, Bronx, NY, United States.'}, {'ForeName': 'Rhett P', 'Initials': 'RP', 'LastName': 'Ketterling', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Hillard', 'Initials': 'H', 'LastName': 'Lazarus', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Witold B', 'Initials': 'WB', 'LastName': 'Rybka', 'Affiliation': 'Penn State Hershey Cancer Institute, Hershey, PA, United States.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Craig', 'Affiliation': 'West Virginia University Healthcare, Morgantown, WB, United States.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Karp', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Brenda W', 'Initials': 'BW', 'LastName': 'Cooper', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Adel Z', 'Initials': 'AZ', 'LastName': 'Makary', 'Affiliation': 'Geisinger Medical Center, Danville, PA, United States.'}, {'ForeName': 'Lynne S', 'Initials': 'LS', 'LastName': 'Kaminer', 'Affiliation': 'North Shore Health System-Evanston Hospital, Evanston, IL, United States.'}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Northwestern University, Chicago, IL, United States(1); Memorial Sloan Kettering Cancer Center, NY, NY, United States(2).'}]",Leukemia research,['10.1016/j.leukres.2021.106736']
3209,34773725,"A single-blinded, randomized, controlled trial comparing efficacy between low-fluence alexandrite 755-nm picosecond laser and low-fluence neodymium-doped yttrium aluminum garnet (Nd:YAG) 1064-nm picosecond laser for the treatment of ultraviolet B-induced hyperpigmentation.","BACKGROUND


Hyperpigmentation is a common concern of patients in dermatology clinics. Although there are many treatment options, lasers are considered a promising therapy for various hyperpigmentary conditions.
OBJECTIVES


This study aims to evaluate the efficacy of alexandrite 755-nm picosecond and neodymium-doped yttrium aluminum garnet (Nd:YAG) 1064-nm picosecond lasers for the treatment of ultraviolet B (UVB)-induced hyperpigmentation in Asians.
MATERIALS AND METHODS


A randomized, single-blinded study was conducted. UVB-induced hyperpigmentation was performed in three spots by narrowband UVB. After 2 weeks, these three spots were allocated into 755-treated, 1064-treated, and control sites. Patients received weekly laser treatments for five sessions. Follow-ups were scheduled at 1 and 2 months after the last session.
RESULTS


Twenty patients attended the study. Overall, 755-nm and 1064-nm picosecond lasers showed a significant improvement in the mean lightness index (L*) compared to the control site, which started at Day 49 and Day 77, respectively. The mean L* of the 755-nm-treated site was also higher than that of the 1064-nm-treated site at Day 105 (p ≤ 0.001). Initially, the mean L*, physician's visual analog scale (VAS), and patient satisfaction with the 1064-nm picosecond laser were better than those with the 755-nm picosecond laser. Nevertheless, an inversion of the mean L* and VAS was noted at Day 49, whereas the mean patient satisfaction was noted at Day 77. In the subgroup analysis, a 755-nm picosecond laser effectively treated Fitzpatrick skin types (FPTs) III and IV. However, the mean L* of the 1064-nm picosecond laser was not significantly different from that of the control for FPT4.
CONCLUSION


The alexandrite 755-nm picosecond and Nd:YAG 1064-nm picosecond lasers appear to be effective and safe modalities for treating UVB-induced hyperpigmentation. With the setting employed in this study, the outcome after the 755-nm picosecond laser treatment seemed superior to that of the 1064-nm picosecond laser treatment, especially for FPT4.",2021,:YAG 1064-nm picosecond lasers appear to be effective and safe modalities for treating UVB-induced hyperpigmentation.,"['ultraviolet B (UVB)-induced hyperpigmentation in Asians', 'ultraviolet B-induced hyperpigmentation', 'Twenty patients attended the study', 'patients in dermatology clinics']","['alexandrite 755-nm picosecond and neodymium-doped yttrium aluminum garnet (Nd:YAG) 1064-nm picosecond lasers', 'low-fluence alexandrite 755-nm picosecond laser and low-fluence neodymium-doped yttrium aluminum garnet']","['mean lightness index (L', 'UVB-induced hyperpigmentation', ""mean L*, physician's visual analog scale (VAS), and patient satisfaction with the 1064-nm picosecond laser"", 'mean patient satisfaction', 'inversion of the mean L* and VAS']","[{'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3812390', 'cui_str': 'Dermatology clinic'}]","[{'cui': 'C0675767', 'cui_str': 'alexandrite'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C1532556', 'cui_str': 'Picosecond pulsed laser device'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1532556', 'cui_str': 'Picosecond pulsed laser device'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}]",,0.104584,:YAG 1064-nm picosecond lasers appear to be effective and safe modalities for treating UVB-induced hyperpigmentation.,"[{'ForeName': 'Vasanop', 'Initials': 'V', 'LastName': 'Vachiramon', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Amornrut', 'Initials': 'A', 'LastName': 'Namasondhi', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tanaporn', 'Initials': 'T', 'LastName': 'Anuntrangsee', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Natthachat', 'Initials': 'N', 'LastName': 'Jurairattanaporn', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14591']
3210,34731640,A randomized control trial comparing vaginal and laparoscopically-assisted vaginal hysterectomy in the absence of uterine prolapse in a South African tertiary institution.,"OBJECTIVES


The primary objectives of this study were to estimate blood loss, operation time and cost differences in patients undergoing vaginal hysterectomy (VH) versus laparoscopically-assisted vaginal hysterectomy (LAVH). The secondary objectives were to determine differences in hospital stay, need for postoperative analgesia, intra- and immediate post-operative complications, and the rate of conversion to laparotomy. VH was hypothesized to be the preferred route for hysterectomy for benign uterine conditions.
STUDY DESIGN


A randomized control study was undertaken at the Department of Obstetrics and Gynaecology of the Charlotte Maxeke Johannesburg Academic Hospital and included the women admitted between January 2017 and December 2019 for hysterectomy due to benign conditions, meeting the inclusion criteria (vaginally accessible uterus, estimated uterine size ≤ 12 weeks of gestation or ≤ 280 g on ultrasound examination and pathology confined to the uterus). Surgical procedures were performed by the residents in training under the supervision of specialists with large experience. The patient demographic characteristics, uterine weight, operative time, estimated blood loss(expressed as the difference between preoperative and postoperative day one serum haemoglobin),direct surgery-associated costs, intra- and immediate post-operative complications and the length of hospital stay were recorded and comparatively analysed among patients randomly placed in VH and LAVH group.
RESULTS


A total of 227 women were included (151 patients underwent VH and 76 LAVH, upon 2:1 randomization, performed on this way to reflect the previous pattern of operating of the unit). The patients were matched with respect to age, parity and body mass index. No significant differences between two groups were found in mean uterine weight and also in mean serum haemoglobin shift, intra- and immediate post-operative complications, and convalescence period duration. There were statistically significant differences in operating time and in cost between the two procedures. On average, LAVH took longer than VH to be performed (62.8 ± 9.3 vs 29.9 ± 6.6 min, p < 0.0001) and it was more costly, mainly due to the longer operating time and required disposables. An amount of 15698.20 South African Rand (ZAR) or 1145.85 United States Dollar (USD) more were needed to perform LAVH in comparison to VH. All VHs and LAVHs were successfully accomplished without major complications or conversation to laparotomy.
CONCLUSION


Our data indicate that VH is a feasible and safe alternative for a large group of women with benign pathology and non-prolapsed uteri, being a faster and less costly procedure than LAVH.",2021,"No significant differences between two groups were found in mean uterine weight and also in mean serum haemoglobin shift, intra- and immediate post-operative complications, and convalescence period duration.","['Department of Obstetrics and Gynaecology of the Charlotte Maxeke Johannesburg Academic Hospital and included the women admitted between January 2017 and December 2019 for hysterectomy due to benign conditions, meeting the inclusion criteria (vaginally accessible uterus, estimated uterine size\xa0≤\xa012\xa0weeks of gestation or\xa0≤', '15698.20 South African Rand (ZAR) or 1145.85 United States Dollar (USD', 'patients undergoing', 'uterine prolapse in a South African tertiary institution', '227 women were included (151 patients underwent VH and 76 LAVH']","['VH', 'vaginal hysterectomy (VH) versus laparoscopically-assisted vaginal hysterectomy (LAVH', 'vaginal and laparoscopically-assisted vaginal hysterectomy']","['hospital stay, need for postoperative analgesia, intra- and immediate post-operative complications, and the rate of conversion to laparotomy', 'mean uterine weight', 'operating time and in cost', 'patient demographic characteristics, uterine weight, operative time, estimated blood loss(expressed as the difference between preoperative and postoperative day one serum haemoglobin),direct surgery-associated costs, intra- and immediate post-operative complications and the length of hospital stay', 'blood loss, operation time and cost differences', 'mean serum haemoglobin shift, intra- and immediate post-operative complications, and convalescence period duration']","[{'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0562019', 'cui_str': 'dollar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042140', 'cui_str': 'Uterine prolapse'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0009940', 'cui_str': 'Convalescence'}, {'cui': 'C0425943', 'cui_str': 'Duration of menstrual flow'}]",227.0,0.0357624,"No significant differences between two groups were found in mean uterine weight and also in mean serum haemoglobin shift, intra- and immediate post-operative complications, and convalescence period duration.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Chrysostomou', 'Affiliation': 'Department of Obstetrics, Gynaecology, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Djokovic', 'Affiliation': 'Maternidade Dr. Alfredo da Costa, Centro Hospitalar Universitário Lisboa Central (CHULC), Lisbon, Portugal; Department of Obstetrics and Gynecology, NOVA Medical School, Faculdade de CiênciasMédicas, NOVA University of Lisbon, Lisbon, Portugal; Department of Obstetrics and Gynecology, Hospital CUF Descobertas, Lisbon, Portugal. Electronic address: dusan.djokovic@nms.unl.pt.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Libhaber', 'Affiliation': 'School of Clinical Medicine and Health Sciences Research Office, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Edridge', 'Affiliation': 'Department of Obstetrics and Gynaecology, CHBH, Johannesburg, South Africa.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Kawonga', 'Affiliation': 'Department of Community Health, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Bruno J', 'Initials': 'BJ', 'LastName': 'van Herendael', 'Affiliation': ""Stuivenberg General Hospital, ZiekenhuisNetwerkAntwerpen (ZNA), Antwerp, Belgium; UniversitàdegliStudidell'Insubria, Varese, Italy.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2021.10.018']
3211,34758251,A Randomized Trial of Intravenous Alteplase before Endovascular Treatment for Stroke.,"BACKGROUND


The value of administering intravenous alteplase before endovascular treatment (EVT) for acute ischemic stroke has not been studied extensively, particularly in non-Asian populations.
METHODS


We performed an open-label, multicenter, randomized trial in Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT and who were eligible for intravenous alteplase and EVT. Patients were randomly assigned in a 1:1 ratio to receive EVT alone or intravenous alteplase followed by EVT (the standard of care). The primary end point was functional outcome on the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 90 days. We assessed the superiority of EVT alone over alteplase plus EVT, as well as noninferiority by a margin of 0.8 for the lower boundary of the 95% confidence interval for the odds ratio of the two trial groups. Death from any cause and symptomatic intracerebral hemorrhage were the main safety end points.
RESULTS


The analysis included 539 patients. The median score on the modified Rankin scale at 90 days was 3 (interquartile range, 2 to 5) with EVT alone and 2 (interquartile range, 2 to 5) with alteplase plus EVT. The adjusted common odds ratio was 0.84 (95% confidence interval [CI], 0.62 to 1.15; P = 0.28), which showed neither superiority nor noninferiority of EVT alone. Mortality was 20.5% with EVT alone and 15.8% with alteplase plus EVT (adjusted odds ratio, 1.39; 95% CI, 0.84 to 2.30). Symptomatic intracerebral hemorrhage occurred in 5.9% and 5.3% of the patients in the respective groups (adjusted odds ratio, 1.30; 95% CI, 0.60 to 2.81).
CONCLUSIONS


In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke. The incidence of symptomatic intracerebral hemorrhage was similar in the two groups. (Funded by the Collaboration for New Treatments of Acute Stroke consortium and others; MR CLEAN-NO IV ISRCTN number, ISRCTN80619088.).",2021,"In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke.","['Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT and who were eligible for intravenous alteplase and EVT', 'Stroke', '539 patients']","['EVT alone over alteplase plus EVT', 'endovascular treatment (EVT', 'Intravenous Alteplase', 'EVT alone or intravenous alteplase followed by EVT']","['symptomatic intracerebral hemorrhage', 'Symptomatic intracerebral hemorrhage', 'median score on the modified Rankin scale', 'Mortality', 'modified Rankin scale (range, 0 [no disability] to 6 [death']","[{'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",539.0,0.3651,"In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke.","[{'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'LeCouffe', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Kappelhof', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Leon A', 'Initials': 'LA', 'LastName': 'Rinkel', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Agnetha E', 'Initials': 'AE', 'LastName': 'Bruggeman', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Olvert A', 'Initials': 'OA', 'LastName': 'Berkhemer', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Lennard', 'Initials': 'L', 'LastName': 'Wolff', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van Voorst', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Manon L', 'Initials': 'ML', 'LastName': 'Tolhuisen', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Adriaan C G M', 'Initials': 'ACGM', 'LastName': 'van Es', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Jelis', 'Initials': 'J', 'LastName': 'Boiten', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Geert J', 'Initials': 'GJ', 'LastName': 'Lycklama À Nijeholt', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Koos', 'Initials': 'K', 'LastName': 'Keizer', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Rob A R', 'Initials': 'RAR', 'LastName': 'Gons', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Lonneke S F', 'Initials': 'LSF', 'LastName': 'Yo', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'H Bart', 'Initials': 'HB', 'LastName': 'van der Worp', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Rob T H', 'Initials': 'RTH', 'LastName': 'Lo', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Ido R', 'Initials': 'IR', 'LastName': 'van den Wijngaard', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Inger R', 'Initials': 'IR', 'LastName': 'de Ridder', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Costalat', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Arquizan', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lemmens', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Demeestere', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Hofmeijer', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Jasper M', 'Initials': 'JM', 'LastName': 'Martens', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Schonewille', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Jan-Albert', 'Initials': 'JA', 'LastName': 'Vos', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Uyttenboogaart', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Reinoud P H', 'Initials': 'RPH', 'LastName': 'Bokkers', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'van Tuijl', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kortman', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Floris H B M', 'Initials': 'FHBM', 'LastName': 'Schreuder', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Hieronymus D', 'Initials': 'HD', 'LastName': 'Boogaarts', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Karlijn F', 'Initials': 'KF', 'LastName': 'de Laat', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Lukas C', 'Initials': 'LC', 'LastName': 'van Dijk', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Heleen M', 'Initials': 'HM', 'LastName': 'den Hertog', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Boudewijn A A M', 'Initials': 'BAAM', 'LastName': 'van Hasselt', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Paul J A M', 'Initials': 'PJAM', 'LastName': 'Brouwers', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Bulut', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Michel J M', 'Initials': 'MJM', 'LastName': 'Remmers', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'van Norden', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Imani', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Anouk D', 'Initials': 'AD', 'LastName': 'Rozeman', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Otto E H', 'Initials': 'OEH', 'LastName': 'Elgersma', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Desfontaines', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Brisbois', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Samson', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Clarençon', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'G Menno', 'Initials': 'GM', 'LastName': 'Krietemeijer', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Alida A', 'Initials': 'AA', 'LastName': 'Postma', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Pieter-Jan', 'Initials': 'PJ', 'LastName': 'van Doormaal', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'van den Berg', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'van der Hoorn', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Ludo F M', 'Initials': 'LFM', 'LastName': 'Beenen', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Nieboer', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'From the Departments of Neurology (N.E.L., L.A.R., J.M.C., Y.B.W.E.M.R.), Radiology and Nuclear Medicine (M.K., K.M.T., A.E.B., O.A.B., H.V., M.L.T., R.B., L.F.M.B., B.J.E., C.B.L.M.M.), and Biomedical Engineering and Physics (O.A.B., H.V., M.L.T.), Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Departments of Radiology (K.M.T., G.J.L.N., I.R.W.) and Neurology (J.B., I.R.W.), The Hague Medical Center, and the Departments of Neurology (K.F.L.) and Radiology (L.C.D.), Haga Hospital, The Hague, the Departments of Radiology and Nuclear Medicine (O.A.B., L.W., A.L., P.-J.D.), Neurology (D.W.J.D., B.R.), and Public Health (D.N., H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Department of Radiology, Leiden University Medical Center, Leiden (A.C.G.M.E.), the Departments of Neurology (K.K., R.A.R.G.) and Radiology (L.S.F.Y., G.M.K.), Catharina Hospital, Eindhoven, the Department of Neurology, Cardiovascular Research Institute Maastricht (R.J.O., I.R.R.), and the Department of Radiology and Nuclear Medicine (W.H.Z., A.A.P.), Maastricht University Medical Center, and the School for Mental Health and Sciences, Maastricht University (A.A.P.), Maastricht, the Department of Neurology and Neurosurgery, Brain Center (H.B.W.), and the Department of Radiology (R.T.H.L.), University Medical Center Utrecht, Utrecht, the Departments of Neurology (J.H.) and Radiology (J.M.M.), Rijnstate Hospital, Arnhem, the Departments of Neurology (W.J.S.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, the Departments of Neurology (M.U.) and Radiology, Medical Imaging Center (R.P.H.B., A.H.), University Medical Center Groningen, Groningen, the Departments of Neurology (J.H.T.) and Radiology (H.K.), Elisabeth-TweeSteden Hospital, Tilburg, Radboud University Medical Center, Donders Institute for Brain, Cognition, and Behavior, Department of Neurology (F.H.B.M.S.), and the Department of Neurosurgery, Radboud University Medical Center (H.D.B.), Nijmegen, the Departments of Neurology (H.M.H.) and Radiology and Nuclear Medicine (B.A.A.M.H.), Isala Hospital, Zwolle, the Departments of Neurology (P.J.A.M.B.) and Radiology (T.B.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (M.J.M.R., A.N.) and Radiology (F.I.), Amphia Hospital, Breda, and the Departments of Neurology (A.D.R.) and Radiology (O.E.H.E.), Albert Schweitzer Hospital, Dordrecht - all in the Netherlands; the Departments of Neuroradiology (V.C.) and Neurology (C.A.), Centre Hospitalier Universitaire de Montpellier, Montpellier, and the Departments of Neurology (Y.S.) and Neuroradiology (F.C.), Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris - both in France; and the Department of Neurosciences, KU Leuven-University of Leuven, Experimental Neurology (R.L., J.D.), Vlaams Instituut voor Biotechnologie Center for Brain and Disease Research (R.L., J.D.), and University Hospitals Leuven, Department of Neurology (R.L., J.D.), Leuven, and the Departments of Neurology (P.D.) and Radiology (D.B.), Centre Hospitalier Chrétien, Liege - all in Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2107727']
3212,34758210,Peer-Delivered Cognitive-Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial.,"
Objective:  To determine if a 9-week group cognitive-behavioral therapy (CBT) intervention delivered by women who have recovered from postpartum depression (peers) can effectively reduce symptoms of postpartum depression (PPD) and anxiety and improve social support and the mother-infant relationship.
Methods:  A sample of 73 mothers living in Ontario, Canada, were randomized into experimental and waitlist control groups between March 2018 and February 2020. Participants were ≥ 18 years of age, had an infant < 12 months old, were fluent in English, and scored ≥ 10 on the Edinburgh Postnatal Depression Scale. The experimental group completed the 9-week group CBT intervention immediately after study enrollment, while the control group did so after a 9-week waiting period. All outcomes were assessed at enrollment (n = 54) and 9 weeks later (n = 38). Outcomes were assessed in the experimental group at 6 months to assess treatment stability.
Results:  Peer-delivered group CBT for PPD led to clinically and statistically significant improvements in symptoms of depression ( F 1,47  = 22.52,  P  < .01) and anxiety ( F 1,45  = 20.56,  P  < .05) in the experimental group, and these improvements were stable at the 6-month follow-up. Perceptions of impaired mother-infant bonding ( t 15  = 3.72,  P  < .01) and rejection and pathological anger ( t 15  = 3.01,  P  < .01) also decreased at the 6-month follow-up in the experimental group.
Conclusions:  Peer-delivered group CBT for PPD effectively treats symptoms of PPD and anxiety and may lead to improvements in the mother-infant relationship. This intervention is an effective and potentially scalable means by which access to a treatment that meets the needs and wants of mothers with PPD can be increased.
Trial Registration:  ClinicalTrials.gov Identifier: NCT03285139.",2021,"Peer-delivered group CBT for PPD led to clinically and statistically significant improvements in symptoms of depression ( F 1,47  = 22.52,  P  < .01) and anxiety ( F 1,45  = 20.56,  P  < .05) in the experimental group, and these improvements were stable at the 6-month follow-up.","['Postpartum Depression', 'women who have recovered from postpartum depression (peers', '73 mothers living in Ontario, Canada', 'Participants were ≥\u200918 years of age, had an infant\u2009<\u200912 months old, were fluent in English, and scored\u2009≥\u200910 on the Edinburgh Postnatal Depression Scale']","['Peer-Delivered Cognitive-Behavioral Therapy', 'CBT intervention', '9-week group cognitive-behavioral therapy (CBT) intervention']","['anxiety', 'postpartum depression (PPD) and anxiety and improve social support', 'symptoms of depression', 'rejection and pathological anger', 'Perceptions of impaired mother-infant bonding']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",73.0,0.0274937,"Peer-delivered group CBT for PPD led to clinically and statistically significant improvements in symptoms of depression ( F 1,47  = 22.52,  P  < .01) and anxiety ( F 1,45  = 20.56,  P  < .05) in the experimental group, and these improvements were stable at the 6-month follow-up.","[{'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Amani', 'Affiliation': 'Neuroscience Graduate Program, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Donya', 'Initials': 'D', 'LastName': 'Merza', 'Affiliation': 'Neuroscience Graduate Program, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Calan', 'Initials': 'C', 'LastName': 'Savoy', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Streiner', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bieling', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario Canada.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ferro', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Van Lieshout', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario Canada.'}]",The Journal of clinical psychiatry,['10.4088/JCP.21m13928']
3213,34758186,A randomised trial of single or extended dosing ciprofloxacin versus no intervention for Prevention of Ventilation Tube Otorrhoea and Obstruction (PreVenTO2).,"OBJECTIVES


To determine the effectiveness of ciprofloxacin 0.3% antibiotic eardrops in preventing clinically significant postoperative otorrhoea and tube obstruction following grommet insertion in children.
DESIGN


3-arm parallel assessor-blinded randomised controlled trial. Randomisation in 1:1:1 ratio to single intraoperative application of ciprofloxacin drops, extended 5-day postoperative application and no drops. Patients were assessed by blinded assessors at 6 weeks postoperatively.
SETTING


The study was conducted in a large tertiary health network in Melbourne, Australia.
PARTICIPANTS


All children, 17 years and under, undergoing bilateral MEVT surgery with or without concurrent upper airway surgery for recurrent acute otitis media and chronic otitis media with effusion were approached.
MAIN OUTCOME MEASURES


Presence of postoperative otorrhoea and ventilation tube obstruction at 6 weeks postoperatively.
RESULTS


256 paediatric patients completed the study with a median age of 4.02 years. 153 participants were male. By ear-analysis (n=512) showed intraoperative antibiotics were more effective than no drops in preventing otorrhoea (RR=0.341, 95%CI 0.158-0.738, NNT= 11.25, p=.006). Postoperative antibiotics were more effective than no drops in preventing ventilation tube obstruction (RR=0.424, 95%CI 0.193 to 0.930, NNT=14.7 p=.032).
CONCLUSION


Intraoperative topical ciprofloxacin was effective at preventing early postoperative otorrhoea and a prolonged course was effective at preventing ventilation tube obstruction. Future studies on this topic should seek to clarify whether particular subgroups of patients benefit more from prophylactic topical antibiotics and model for cost-effectiveness.",2021,"Postoperative antibiotics were more effective than no drops in preventing ventilation tube obstruction (RR=0.424, 95%CI 0.193 to 0.930, NNT=14.7 p=.032).
","['All children, 17 years and under, undergoing', 'The study was conducted in a large tertiary health network in Melbourne, Australia', 'for recurrent acute otitis media and chronic otitis media with effusion were approached', '153 participants were male', '256 paediatric patients completed the study with a median age of 4.02 years', 'children']","['ciprofloxacin 0.3% antibiotic eardrops', 'bilateral MEVT surgery with or without concurrent upper airway surgery', 'Intraoperative topical ciprofloxacin', 'ciprofloxacin']","['ventilation tube obstruction', 'postoperative otorrhoea and ventilation tube obstruction', 'intraoperative antibiotics', 'Ventilation Tube Otorrhoea and Obstruction (PreVenTO2']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0395866', 'cui_str': 'Recurrent acute otitis media'}, {'cui': 'C2242816', 'cui_str': 'Chronic secretory otitis media'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0155540', 'cui_str': 'Ear discharge'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",153.0,0.126452,"Postoperative antibiotics were more effective than no drops in preventing ventilation tube obstruction (RR=0.424, 95%CI 0.193 to 0.930, NNT=14.7 p=.032).
","[{'ForeName': 'Luke Chenkan', 'Initials': 'LC', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, School of Clinical Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Phyland', 'Affiliation': 'Department of Surgery, School of Clinical Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Charles Edward', 'Initials': 'CE', 'LastName': 'Giddings', 'Affiliation': 'Department of Surgery, School of Clinical Sciences, Monash University, Melbourne, Australia.'}]",Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery,['10.1111/coa.13887']
3214,34392382,Imageless robotic-assisted total knee arthroplasty accurately restores the radiological alignment with a short learning curve: a randomized controlled trial.,"PURPOSE


The study compared a novel imageless robotic-assisted total knee arthroplasty (RATKA) and conventional TKA by considering (1) radiological outcomes, (2) outliers of radiological outcomes, and (3) learning curve.
METHODS


This prospective randomized controlled study performed by a single surgeon evaluated 152 patients (152 knees): 75 patients undergoing RATKA and 77 patients undergoing conventional TKA. Mechanical alignment, radiological implant positioning, and outliers were analyzed for radiological outcomes. Cumulative summation (CUSUM) analysis was used to assess the learning curve for operative time in RATKA.
RESULTS


The RATKA had significantly better accuracy of knee alignment and component positioning than conventional TKA. The hip-knee-ankle axis and implant position outliers were significantly lower in the RATKA, with 94.7% of patients had achieved an overall mechanical alignment within 3° of a neutral mechanical axis. Changes in posterior condylar offset and joint line were significantly lower in the RATKA. A learning curve of seven cases for operative time was obtained for the RATKA.
CONCLUSION


The imageless RATKA has better alignment accuracy with a short learning curve; thus, it presents an attractive option for TKA.",2021,Changes in posterior condylar offset and joint line were significantly lower in the RATKA.,['152 patients (152 knees): 75 patients undergoing RATKA and 77 patients undergoing'],"['Imageless robotic-assisted total knee arthroplasty', 'conventional TKA', 'novel imageless robotic-assisted total knee arthroplasty (RATKA) and conventional TKA']","['hip-knee-ankle axis and implant position outliers', 'overall mechanical alignment', 'Cumulative summation (CUSUM) analysis', 'posterior condylar offset and joint line']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0234108', 'cui_str': 'Summation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",75.0,0.121858,Changes in posterior condylar offset and joint line were significantly lower in the RATKA.,"[{'ForeName': 'Satit', 'Initials': 'S', 'LastName': 'Thiengwittayaporn', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, 681 Samsen Rd, Dusit, Bangkok, 10300, Thailand. satitthh@hotmail.com.'}, {'ForeName': 'Pinyong', 'Initials': 'P', 'LastName': 'Uthaitas', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, 681 Samsen Rd, Dusit, Bangkok, 10300, Thailand.'}, {'ForeName': 'Chaipipathn', 'Initials': 'C', 'LastName': 'Senwiruch', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, 681 Samsen Rd, Dusit, Bangkok, 10300, Thailand.'}, {'ForeName': 'Natthapong', 'Initials': 'N', 'LastName': 'Hongku', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, 681 Samsen Rd, Dusit, Bangkok, 10300, Thailand.'}, {'ForeName': 'Revit', 'Initials': 'R', 'LastName': 'Tunyasuwanakul', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, 681 Samsen Rd, Dusit, Bangkok, 10300, Thailand.'}]",International orthopaedics,['10.1007/s00264-021-05179-y']
3215,34392115,Improving mental health in low-resource settings: A feasibility randomized controlled trial of a transdiagnostic psychological intervention among Burundian refugee adolescents and their caregivers.,"There is a paucity of evidence regarding interventions that can improve the mental health of adversity-affected young adolescents living in low-resource settings. We evaluated the feasibility, acceptability, relevance, and safety of the World Health Organization's Early Adolescent Skills for Emotions (EASE) intervention among Burundian refugee adolescents and their caregivers in Tanzania. This study consisted of a feasibility cluster randomized controlled trial (cRCT) and a process evaluation. The feasibility cRCT included 82 young adolescents and their 64 caregivers, with two clusters randomized to EASE and two to an enhanced control condition. EASE was delivered by adult refugees without prior training in mental health. The process evaluation consisted of 36 semi-structured qualitative interviews with key stakeholders, including adolescents, caregivers, and facilitators. EASE participants and facilitators gave positive feedback about its format, accessibility, and content. Trained non-specialist refugee facilitators were able to deliver EASE with high fidelity. The research protocol functioned well in terms of balanced randomization, limited loss to follow-up, and psychometrically promising measures, but discordance was observed between the short screener and psychological distress symptom checklist. This formative study suggests the potential of EASE in targeting psychological distress among displaced young adolescents and lays the groundwork for a future definitive trial.",2021,"The research protocol functioned well in terms of balanced randomization, limited loss to follow-up, and psychometrically promising measures, but discordance was observed between the short screener and psychological distress symptom checklist.","['Burundian refugee adolescents and their caregivers in Tanzania', '82 young adolescents and their 64 caregivers, with two clusters randomized to EASE and two to an enhanced control condition', 'displaced young adolescents', 'Burundian refugee adolescents and their caregivers']","['transdiagnostic psychological intervention', ""World Health Organization's Early Adolescent Skills for Emotions (EASE) intervention"", 'EASE']","['mental health', 'feasibility, acceptability, relevance, and safety']","[{'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",82.0,0.0684711,"The research protocol functioned well in terms of balanced randomization, limited loss to follow-up, and psychometrically promising measures, but discordance was observed between the short screener and psychological distress symptom checklist.","[{'ForeName': 'Shoshanna L', 'Initials': 'SL', 'LastName': 'Fine', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Baltimore, MD, 21205, USA. Electronic address: slfine@jhu.edu.'}, {'ForeName': 'Aiysha', 'Initials': 'A', 'LastName': 'Malik', 'Affiliation': 'World Health Organization, Avenue Appia 20, 1211, Geneva, Switzerland.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Guimond', 'Affiliation': 'International Rescue Committee, 122 East 42nd St., New York, NY, 10168, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Nemiro', 'Affiliation': 'International Rescue Committee, 122 East 42nd St., New York, NY, 10168, USA.'}, {'ForeName': 'Getruda', 'Initials': 'G', 'LastName': 'Temu', 'Affiliation': 'International Rescue Committee, 122 East 42nd St., New York, NY, 10168, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Likindikoki', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es Salaam, Tanzania.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Annan', 'Affiliation': 'International Rescue Committee, 122 East 42nd St., New York, NY, 10168, USA.'}, {'ForeName': 'Wietse A', 'Initials': 'WA', 'LastName': 'Tol', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Baltimore, MD, 21205, USA; Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1353, Copenhagen, Denmark; HealthRight International, 14 East 14th St., New York, NY, 10012, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103944']
3216,34391923,Risk of Pancreatitis Following Biliary Stenting With/Without Endoscopic Sphincterotomy: A Randomized Controlled Trial.,"BACKGROUND & AIMS


The efficacy of endoscopic sphincterotomy (ES) before endoscopic transpapillary biliary drainage in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been established. The aim of this study was to evaluate the effect of performing ES before biliary stent/tube placement on the occurrence of PEP.
METHODS


Three hundred seventy patients with biliary stricture requiring endoscopic biliary stenting were enrolled and randomly allocated to the ES group (n = 185) or non-ES group (n = 185). All participants were followed up for 30 days after the procedure. The data and occurrence of adverse events were prospectively collected. The primary outcome measure of this study was the incidence of PEP within 2 days of initial transpapillary biliary drainage. Secondary outcome measures were the incidence of other adverse events related to biliary stent/tube placement.
RESULTS


PEP occurred in 36 patients (20.6%) in the non-ES group and in 7 patients (3.9%) in the ES group (P < .001). The difference in the incidence of PEP between the 2 groups in the per-protocol population was 16.7% (95% confidence interval, 10.1%-23.3%), which was not within the noninferiority margin of 6%. Except for bleeding, the incidences of other adverse events were not significantly different between the groups.
CONCLUSION


ES before endoscopic biliary stenting could have the preventive effect on the occurrence of PEP in patients with biliary stricture. University Hospital Medical Information Network Number, UMIN000025727.University Hospital Medical Information Network Clinical Trial Registry URL: https://www.umin.ac.jp/ctr/index.htm.",2021,"Except for bleeding, the incidences of other adverse events were not significantly different between the groups.
","['patients with biliary stricture', 'Three-hundred seventy patients with biliary stricture requiring endoscopic biliary stenting']","['endoscopic sphincterotomy before biliary stent/tube placement', 'endoscopic sphincterotomy group (ES group, n = 185) or non-endoscopic sphincterotomy group (non-ES', 'biliary stenting with/without endoscopic sphincterotomy', 'endoscopic sphincterotomy before endoscopic transpapillary biliary drainage']","['incidence of other adverse events related to biliary stent/tube placement', 'PEP', 'incidence of PEP within 2 days of initial transpapillary biliary drainage', 'Risk of pancreatitis', 'incidence of PEP', 'bleeding, the incidences of other adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0597984', 'cui_str': 'Biliary stricture'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0183512', 'cui_str': 'Biliary stent'}]","[{'cui': 'C0085263', 'cui_str': 'Endoscopic Sphincterotomy'}, {'cui': 'C0183512', 'cui_str': 'Biliary stent'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0442370', 'cui_str': 'Transpapillary approach - duodenal'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0183512', 'cui_str': 'Biliary stent'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0442370', 'cui_str': 'Transpapillary approach - duodenal'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",370.0,0.103509,"Except for bleeding, the incidences of other adverse events were not significantly different between the groups.
","[{'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan; Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kuwatani', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Sapporo, Japan; Division of Endoscopy, Hokkaido University Hospital, Sapporo, Japan. Electronic address: mkuwatan@med.hokudai.ac.jp.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Onodera', 'Affiliation': 'Department of Gastroenterology, NTT Medical Center Sapporo Hospital, Sapporo, Japan.'}, {'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan.'}, {'ForeName': 'Itsuki', 'Initials': 'I', 'LastName': 'Sano', 'Affiliation': 'Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Katanuma', 'Affiliation': 'Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Uebayashi', 'Affiliation': 'Department of Gastroenterology, Kitami Red Cross Hospital, Kitami, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Eto', 'Affiliation': 'Department of Gastroenterology, Tomakomai Municipal Hospital, Tomakomai, Japan.'}, {'ForeName': 'Mitsuharu', 'Initials': 'M', 'LastName': 'Fukasawa', 'Affiliation': 'First Department of Internal Medicine, University of Yamanashi, Chuo, Japan.'}, {'ForeName': 'Shunpei', 'Initials': 'S', 'LastName': 'Hashigo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Iwashita', 'Affiliation': 'First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Medical Oncology, Sapporo Medical University Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Taya', 'Affiliation': 'Department of Gastroenterology, NHO Hokkaido Medical Center, Sapporo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'Department of Gastroenterology, University of Miyazaki Hospital, Miyazaki, Japan.'}, {'ForeName': 'Hironari', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Yousuke', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital, Tokyo, Japan; Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kasen', 'Initials': 'K', 'LastName': 'Kobashigawa', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Gastroenterology, Urasoe General Hospital, Urasoe, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Kawahata', 'Affiliation': 'Department of Gastroenterology, Obihiro-Kosei General Hospital, Obihiro, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Shinoura', 'Affiliation': 'Department of Gastroenterology, Okinawa Prefectural Chubu Hospital, Uruma, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterology, Sendai Open Hospital, Sendai, Japan.'}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Kubo', 'Affiliation': 'Department of Gastroenterology, NHO Hakodate Hospital, Hakodate, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Yamato', 'Affiliation': 'Department of Gastroenterology, Iwamizawa Municipal General Hospital, Iwamizawa, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Iruru', 'Initials': 'I', 'LastName': 'Maetani', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Mukai', 'Affiliation': 'Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Shibukawa', 'Affiliation': 'Department of Gastroenterology, Fukushima Medical University, Aizu Medical Center, Aizu, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Itoi', 'Affiliation': 'Department of Gastroenterology, Tokyo Medical University Hospital, Tokyo, Japan.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2021.08.016']
3217,34398400,Comparison of open and a novel closed vitrification system with slow freezing for human ovarian tissue cryopreservation.,"PURPOSE


To investigate the differences concerning post-thawing/warming follicle survival, DNA damage and apoptosis in human ovarian tissues cryopreserved by slow freezing, open, or closed vitrification methods.
METHODS


A total of 50 pieces of 5 × 5 × 1 mm ovarian cortical pieces were harvested (5 donor ovaries; mean age 31 ± 6.62 years). From each donor, one cortical piece was used as baseline; the remaining were randomly assigned to slow freezing (SF), vitrification using open device (VF-open), or closed device (VF-closed) groups. After 8-10 weeks of cryostorage, tissues were evaluated 4 h after thawing/warming. Histological analysis was evaluated for follicle survival (primordial and primary follicle densities) by H&E staining. The percentages of primordial and primary follicles with DNA double-strand breaks (γH2AX) and apoptotic cell death pathway activation (AC3) were immunohistochemically assessed. Data were analysed using one-way ANOVA and LSD post hoc comparison.
RESULTS


Compared to the baseline, primordial follicle (pdf) densities significantly declined in all cryopreserved groups (SF, VF-open, and VF-closed, P < 0.05). However, the total and non-apoptotic pdf densities were similar among SF, VF-open, and VF-closed. SF and VF with either open or closed devices did not increase the percentages of primordial or primary follicles with DNA double-strand breaks (DSBs) or apoptosis compared to the baseline or among the freezing methods in the present study.
CONCLUSION


Based on the intact primordial follicle survival, DNA damage, and apoptosis rates after thawing/warming, SF vs VF with either open or newly developed closed devices appear to be comparable.",2021,"SF and VF with either open or closed devices did not increase the percentages of primordial or primary follicles with DNA double-strand breaks (DSBs) or apoptosis compared to the baseline or among the freezing methods in the present study.
","['A total of 50 pieces of 5\u2009×\u20095\u2009×\u20091\xa0mm', 'human ovarian tissue cryopreservation']","['SF and VF with either open or closed devices', 'slow freezing (SF), vitrification using open device (VF-open), or closed device (VF-closed']","['percentages of primordial or primary follicles with DNA double-strand breaks (DSBs) or apoptosis', 'percentages of primordial and primary follicles with DNA double-strand breaks (γH2AX) and apoptotic cell death pathway activation (AC3', 'primordial follicle (pdf) densities', 'follicle survival', 'total and non-apoptotic pdf densities', 'intact primordial follicle survival, DNA damage, and apoptosis rates']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C2936610', 'cui_str': 'Glass Transition'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C1511667', 'cui_str': 'Double-Strand DNA Breaks'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0301647', 'cui_str': 'Strand breaks'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}]",,0.102835,"SF and VF with either open or closed devices did not increase the percentages of primordial or primary follicles with DNA double-strand breaks (DSBs) or apoptosis compared to the baseline or among the freezing methods in the present study.
","[{'ForeName': 'Yodo', 'Initials': 'Y', 'LastName': 'Sugishita', 'Affiliation': 'Laboratory of Molecular Reproduction and Fertility Preservation, Department of Obstetrics, Gynecology & Reproductive Sciences, Yale University School of Medicine, 333 Cedar Street, FMB 224, New Haven, CT, 06520, USA.'}, {'ForeName': 'Enes', 'Initials': 'E', 'LastName': 'Taylan', 'Affiliation': 'Laboratory of Molecular Reproduction and Fertility Preservation, Department of Obstetrics, Gynecology & Reproductive Sciences, Yale University School of Medicine, 333 Cedar Street, FMB 224, New Haven, CT, 06520, USA.'}, {'ForeName': 'Tai', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Laboratory of Molecular Reproduction and Fertility Preservation, Department of Obstetrics, Gynecology & Reproductive Sciences, Yale University School of Medicine, 333 Cedar Street, FMB 224, New Haven, CT, 06520, USA.'}, {'ForeName': 'Bunyad', 'Initials': 'B', 'LastName': 'Shahmurzada', 'Affiliation': 'Laboratory of Molecular Reproduction and Fertility Preservation, Department of Obstetrics, Gynecology & Reproductive Sciences, Yale University School of Medicine, 333 Cedar Street, FMB 224, New Haven, CT, 06520, USA.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Obstetrics and Gynecology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Kutluk', 'Initials': 'K', 'LastName': 'Oktay', 'Affiliation': 'Laboratory of Molecular Reproduction and Fertility Preservation, Department of Obstetrics, Gynecology & Reproductive Sciences, Yale University School of Medicine, 333 Cedar Street, FMB 224, New Haven, CT, 06520, USA. info@fertilitypreservation.org.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-021-02297-9']
3218,34397205,Serious Gastrointestinal-Related Adverse Events Among Psoriasis Patients Treated With Guselkumab in VOYAGE 1 and VOYAGE 2.,"BACKGROUND


Anti-interleukin (IL)-17 biologic agents used to treat psoriasis are associated with onset/exacerbation of inflammatory bowel disease (IBD).
OBJECTIVES


To determine the incidence of IBD or serious gastrointestinal-related adverse events (GI SAEs) in patients with moderate-to-severe psoriasis treated with guselkumab, an IL-23p19 inhibitor that indirectly inhibits IL-17, through 4 years in the phase 3 VOYAGE 1 and VOYAGE 2 trials.
METHODS


Patients were randomized to guselkumab 100 mg every-8-weeks or placebo&rarr;guselkumab (week 16), or adalimumab. In VOYAGE 1, all patients received open-label guselkumab starting at week 52. In VOYAGE 2, eligible patients were treated with guselkumab or placebo based on clinical response starting at week 28 and received open-label guselkumab starting at week 76. Cumulative incidence rates of IBD and other GI SAEs were calculated as events per 100 patient-years (PY) through week 204. IBD was defined as AEs of Crohn&rsquo;s disease or ulcerative colitis. Data were summarized for all guselkumab-treated patients for years 1-4.
RESULTS


Of 1721 guselkumab-treated patients, 1612 were exposed for &ge;1 year, 1545 for &ge;2 years, 1454 for &ge;3 years, and 661 for &ge;4 years. For all patients through week 204, the cumulative rate of GI SAEs was 0.45/100PY. Event rates remained stable with longer duration of exposure, ranging from 0.36 to 0.57/100PY. No new or exacerbated cases of IBD were reported.
CONCLUSIONS


No cases of IBD were observed and rates of GI SAEs were low through 4 years of treatment with guselkumab in two large trials of patients with psoriasis. J Drugs Dermatol. 2021;20(8):855-860. doi:10.36849/JDD.6216 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.",2021,No cases of IBD were observed and rates of GI SAEs were low through 4 years of treatment with guselkumab in two large trials of patients with psoriasis.,"['Patients', 'Of 1721 guselkumab-treated patients, 1612 were exposed for &ge;1 year, 1545 for &ge;2 years, 1454 for &ge;3 years, and 661 for &ge;4 years', 'patients with moderate-to-severe psoriasis treated with']","['guselkumab, an IL-23p19 inhibitor', 'adalimumab', 'guselkumab 100 mg every-8-weeks or placebo&rarr;guselkumab', 'guselkumab or placebo']","['rates of GI SAEs', 'cumulative rate of GI SAEs', 'Cumulative incidence rates of IBD and other GI SAEs', 'IBD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]",,0.0984753,No cases of IBD were observed and rates of GI SAEs were low through 4 years of treatment with guselkumab in two large trials of patients with psoriasis.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ''}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': ''}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': ''}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Langley', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Paraneedharan', 'Initials': 'P', 'LastName': 'Ramachandran', 'Affiliation': ''}, {'ForeName': 'Ya Wen', 'Initials': 'YW', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yaung-Kaung', 'Initials': 'YK', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': ''}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.6216']
3219,34397206,Fixed-Combination Halobetasol Propionate/Tazarotene Lotion for Psoriasis in Patients With 3%-5% Affected Body Surface Area.,"INTRODUCTION


Patients with psoriasis and low body surface area (BSA) involvement often experience substantially reduced quality of life and may be candidates for topical therapies. Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) vs vehicle lotion was evaluated in participants with 3% to 5% BSA involvement.
METHODS


In two phase 3, multicenter, double-blind, vehicle-controlled, 8-week studies (ClinicalTrial.gov identifiers: NCT02462070/NCT02462122), adults with moderate/severe investigator&rsquo;s global assessment (IGA) score were randomized 2:1 to once-daily HP/TAZ or vehicle. Pooled post hoc analyses included participants with baseline BSA involvement of 3% to 5%. Measures included treatment success (&ge;2-grade IGA reduction, clear/almost clear score), reduction in affected BSA, and clinically meaningful improvement (reduction) of &ge;4 points on dermatology life quality index (DLQI).
RESULTS


Of 418 participants, 232 had baseline BSA involvement of 3% to 5% (HP/TAZ, n=149; vehicle, n=83). At week 8, 42.7% of HP/TAZ-treated participants achieved treatment success, compared with 11.4% of vehicle-treated participants (P&lt; .001). Participants experienced significantly greater reductions in affected BSA at week 8 with HP/TAZ (-36.0%) vs vehicle (-1.6%; P&lt; .001). Larger proportions experienced clinically meaningful DLQI improvements at week 8 with HP/TAZ (64.2%) vs vehicle (47.4%; P&lt; .05). More participants achieved a &ge;2-grade improvement in plaque elevation and scaling with HP/TAZ vs vehicle (each comparison, P&lt; .001). Serious adverse events and discontinuations due to treatment-emergent adverse events were rare.
CONCLUSIONS


In participants with plaque psoriasis and BSA involvement of 3% to 5%, HP/TAZ provided significantly improved effectiveness after 8 treatment weeks vs vehicle lotion, with clinically meaningful improvements in quality of life. J Drugs Dermatol. 2021;20(8):829-836. doi:10.36849/JDD.6217.",2021,Participants experienced significantly greater reductions in affected BSA at week 8 with HP/TAZ (-36.0%) vs vehicle (-1.6%; P&lt; .001).,"['adults with moderate/severe investigator&rsquo;s global assessment (IGA) score', 'participants with 3% to 5% BSA involvement', 'Psoriasis in Patients With 3%-5% Affected Body Surface Area', 'Of 418 participants, 232 had baseline BSA involvement of 3% to 5% (HP/TAZ, n=149; vehicle, n=83']","['HP/TAZ', 'vehicle lotion', 'tazarotene (0.045%) lotion (HP/TAZ', 'Fixed-Combination Halobetasol Propionate/Tazarotene Lotion', 'Fixed-combination halobetasol propionate', 'HP/TAZ or vehicle']","['plaque elevation', 'treatment success (&ge;2-grade IGA reduction, clear/almost clear score), reduction in affected BSA, and clinically meaningful improvement (reduction) of &ge;4 points on dermatology life quality index (DLQI', 'quality of life', 'treatment success', 'meaningful DLQI improvements', 'BSA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0098735', 'cui_str': 'Halobetasol propionate'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0288792', 'cui_str': 'tazarotene'}, {'cui': 'C4517410', 'cui_str': '0.045'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0098735', 'cui_str': 'Halobetasol propionate'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0288792', 'cui_str': 'tazarotene'}, {'cui': 'C4517410', 'cui_str': '0.045'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.252626,Participants experienced significantly greater reductions in affected BSA at week 8 with HP/TAZ (-36.0%) vs vehicle (-1.6%; P&lt; .001).,"[{'ForeName': 'Emil A', 'Initials': 'EA', 'LastName': 'Tanghetti', 'Affiliation': ''}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Bhatia', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Drew', 'Affiliation': ''}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.6217']
3220,34397196,Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials.,"BACKGROUND


Psoriasis vulgaris is not easy to manage, even when mild. Knowledge of the efficacy of most topical therapies in this population is limited.
OBJECTIVE


To assess the efficacy of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam in patients with mild psoriasis.
METHODS


Post hoc analysis was performed on pooled data for subjects with mild psoriasis at baseline from 2 Phase 3 and 1 Phase 2 clinical trials. All subjects applied Cal/BD foam or vehicle foam once daily for at least 4 weeks. Efficacy assessments included treatment success (defined as IGA=0), mPASI, BSA, and the composite IGA&ensp;BSA score.
RESULTS


Of the 848 subjects, 164 had mild psoriasis at baseline. Within this subpopulation of mild subjects, Cal/BD foam demonstrated significant efficacy over vehicle at week 4 in terms of the proportion of subjects achieving complete clearance of visible lesions (IGA=0). Significant improvements were also observed for mPASI, BSA, and IGA&ensp;BSA score.
LIMITATIONS


These post hoc analyses need to be confirmed with prospective studies.
CONCLUSION


Once-daily Cal/BD foam for 4 weeks demonstrated effectiveness in treating subjects with mild psoriasis, a population in which demonstration of treatment success can be difficult, because of the requirement for complete clearance of visible disease. Clinicaltrials.gov: NCT02132936, NCT01866163, and NCT01536938 J Drugs Dermatol. 2021;20(8):822-828. doi:10.36849/JDD.5743.",2021,"Significant improvements were also observed for mPASI, BSA, and IGA&ensp;BSA score.
","['subjects with mild psoriasis at baseline from 2 Phase 3 and 1 Phase 2 clinical trials', '848 subjects, 164 had mild psoriasis at baseline', 'subjects with mild psoriasis', 'patients with mild psoriasis', 'Mild Psoriasis']","['Calcipotriene Plus Betamethasone Dipropionate Foam', 'betamethasone dipropionate', 'calcipotriene']","['treatment success (defined as IGA=0), mPASI, BSA, and the composite IGA&ensp;BSA score', 'mPASI, BSA, and IGA&ensp;BSA score']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439560', 'cui_str': 'Phase 2'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",848.0,0.107832,"Significant improvements were also observed for mPASI, BSA, and IGA&ensp;BSA score.
","[{'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Veverka', 'Affiliation': ''}, {'ForeName': 'Jes B', 'Initials': 'JB', 'LastName': 'Hansen', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Yaloumis', 'Affiliation': ''}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.5743']
3221,34397746,"Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study.","BACKGROUND


With the highest rates of HIV/AIDS in the United States, Black Americans are still underrepresented in HIV medical research.
SETTING


BRAAVE (NCT03631732) is a randomized, phase 3b, multicenter, open-label US study.
METHODS


Adults identifying as Black or African American and virologically suppressed on 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus third agent were randomized (2:1) to switch to open-label bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) once daily or stay on baseline regimen (SBR) for 24 weeks, after which SBR had delayed switch to B/F/TAF. Resistance to non-NRTIs, protease inhibitors, and/or NRTIs was permitted; integrase strand transfer inhibitor resistance was exclusionary. Primary endpoint was proportion of participants with HIV-1 RNA ≥50 copies/mL at week 24 (snapshot algorithm; noninferiority margin of 6%).
RESULTS


Of 558 screened, 495 were randomized/treated (B/F/TAF n = 330; SBR n = 165). Overall, 32% were ciswomen, 2% transwomen, and 10% had an M184V/I mutation. At week 24, 0.6% on B/F/TAF vs 1.8% on SBR had HIV-1 RNA ≥50 copies/mL (difference -1.2%; 95% confidence interval -4.8% to 0.9%), demonstrating noninferiority of B/F/TAF vs SBR. Proportions with HIV-1 RNA <50 copies/mL at week 24 were 96% B/F/TAF and 95% SBR and remained high at week 48. No participant had treatment-emergent resistance to study drug. Treatments were well tolerated. Study drug-related adverse events, mostly grade 1, occurred in 10% of participants on B/F/TAF through week 48 and led to discontinuation in 9 participants through week 48.
CONCLUSIONS


For Black Americans with HIV, switching to B/F/TAF was noninferior to continuing a variety of regimens, including those with pre-existing NRTI mutations.",2021,Proportions with HIV-1 RNA <50 copies/mL at week 24 were 96% B/F/TAF and 95% SBR and remained high at week 48.,"['Black Americans', 'Adults identifying as Black or African American and virologically suppressed on 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus third agent were randomized (2:1) to']","['switch to open-label bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) once daily or stay on baseline regimen (SBR', 'Bictegravir/Emtricitabine/Tenofovir Alafenamide', 'HIV-1']",['tolerated'],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4542162', 'cui_str': 'emtricitabine, tenofovir alafenamide and bictegravir'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]",[],495.0,0.152114,Proportions with HIV-1 RNA <50 copies/mL at week 24 were 96% B/F/TAF and 95% SBR and remained high at week 48.,"[{'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Hagins', 'Affiliation': 'Chatham CARE Center, Savannah, GA.'}, {'ForeName': 'Princy', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Medicine, Georgetown University, Washington, DC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Saag', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Anson K', 'Initials': 'AK', 'LastName': 'Wurapa', 'Affiliation': 'Infectious Disease Specialists of Atlanta, Atlanta, GA.'}, {'ForeName': 'Indira', 'Initials': 'I', 'LastName': 'Brar', 'Affiliation': 'Department of Medicine, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Berger', 'Affiliation': 'Northstar Medical Center, Chicago, IL.'}, {'ForeName': 'Olayemi', 'Initials': 'O', 'LastName': 'Osiyemi', 'Affiliation': 'Triple O Research Institute, West Palm Beach, FL.'}, {'ForeName': 'Corrilynn O', 'Initials': 'CO', 'LastName': 'Hileman', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Moti N', 'Initials': 'MN', 'LastName': 'Ramgopal', 'Affiliation': 'Midway Immunology and Research Center, Fort Pierce, FL.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': 'Tarrant County Infectious Disease Associates, Fort Worth, TX; and.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Andreatta', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002731']
3222,34396615,Cost-effectiveness analysis of home-based rehabilitation compared to usual care for people with inoperable lung cancer.,"OBJECTIVE


Few economic evaluations of lung cancer rehabilitation exist. The aim of this study was to assess the cost-effectiveness of providing home-based rehabilitation for inoperable lung cancer.
METHODS


A cost-utility analysis alongside a randomised controlled trial (RCT) of rehabilitation compared with usual care. The primary outcome was quality-adjusted life years (QALYs) gained. The incremental cost-effectiveness ratio [ICER (95% CI)] and the net monetary benefit are reported. Value of information (VOI) analysis assessed the need/value of more research.
RESULTS


Seventy participants (34 intervention and 36 usual care), average (SD) age 63.0 (12.0) years, 32 (45.7%) stage IV. The average intervention cost was AU$3421 (AU$5352 usual care), and effect (QALY) was 0.30 (0.31 usual care). The ICER was AU$228,197 (-1,173,194 to 1,101,450) per QALY gained. The net monetary benefit was AU$1508, favouring the intervention. The probability that the intervention was more cost-effective than usual care, at a willingness to pay threshold of AU$50,000, was 75%. VOI analysis showed that additional research to resolve decision uncertainty is potentially worthwhile.
CONCLUSION


A high degree of uncertainty exists regarding the cost-effectiveness of lung cancer rehabilitation. Further RCTs, powered for economic evaluations and utilising rehabilitation sensitive outcomes, are required to support translation of evidence into clinical practice.",2021,"The average intervention cost was AU$3421 (AU$5352 usual care), and effect (QALY) was 0.30 (0.31 usual care).","['Seventy participants (34 intervention and 36 usual care), average (SD) age 63.0 (12.0) years, 32 (45.7', 'people with inoperable lung cancer']",['home-based rehabilitation'],"['average intervention cost was AU$3421 (AU$5352 usual care), and effect (QALY', 'quality-adjusted life years (QALYs) gained', 'cost-effectiveness', 'incremental cost-effectiveness ratio [ICER', 'cost-effective']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.083598,"The average intervention cost was AU$3421 (AU$5352 usual care), and effect (QALY) was 0.30 (0.31 usual care).","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Edbrooke', 'Affiliation': 'Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Denehy', 'Affiliation': 'Allied Health Department, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Patrick', 'Affiliation': 'Statistical Consulting Centre, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Tuffaha', 'Affiliation': 'Centre for the Business and Economics of Health, University of Queensland, Brisbane, Queensland, Australia.'}]",European journal of cancer care,['10.1111/ecc.13501']
3223,34402024,"Neuroprotective Effect of Trans-Resveratrol in Mild to Moderate Alzheimer Disease: A Randomized, Double-Blind Trial.","INTRODUCTION


Amyloid-beta (Aβ) protein is a major component of the extracellular plaque found in the brains of individuals with Alzheimer's disease (AD). In this study, we investigated the effect of trans-resveratrol as an antagonist treatment for moderate to mild AD, as well as its safety and tolerability.
METHODS


This was a case-control study that enrolled 30 selected patients who had been clinically diagnosed with moderate to mild AD. These patients were randomly divided into two groups, namely, a placebo group (n = 15) and a trans-resveratrol group (n = 15) who received 500 mg trans-resveratrol orally once daily for 52 weeks. Brain magnetic resonance imaging (MRI) examinations were performed on and cerebrospinal fluid (CSF) samples were obtained from all participants before (baseline) and after the study (52 weeks). Enzyme-linked immunosorbent assays were used to determine the levels of plasma Aβ40 and Aβ42 and CSF Aβ40 and Aβ42.
RESULTS


The results showed that the changes over the study period in the levels of Aβ40 in the blood and CSF of the patients treated with trans-resveratrol were not statistically significant (P > 0.05). In contrast, patients who received placebo showed a significant decrease in Aβ40 levels compared with that at the beginning of the study (CSF Aβ40: P = 0.024, plasma Aβ40: P = 0.036). Analysis of the images on the brain MRI scans revealed that the brain volume of the patients treated with trans-resveratrol was significantly reduced at 52 weeks (P = 0.011) compared with that of patients in the placebo treatment group, Further analysis indicated that the level of matrix metallopeptidase 9 in the CSF of the patients treated with trans-resveratrol at 52 weeks decreased by 46% compared with that of patients in the placebo group (P = 0.033).
CONCLUSION


These results indicate that trans-resveratrol has potential neuroprotective roles in the treatment of moderate to mild AD and that its mechanism may involve a reduction in the accumulation and toxicity of Aβ in the brain of patients, thereby reducing neuroinflammation.
TRIAL REGISTRATION


Chinese clinical trial registry: CTR20151780X.",2021,Aβ) protein is a major component of the extracellular plaque found in the brains of individuals with Alzheimer's disease (AD).,"['Mild to Moderate Alzheimer Disease', ""individuals with Alzheimer's disease (AD"", 'enrolled 30 selected patients who had been clinically diagnosed with moderate to mild AD']","['Trans-Resveratrol', 'trans-resveratrol group (n\u2009=\u200915) who received 500\xa0mg trans-resveratrol orally once daily for 52\xa0weeks', 'trans-resveratrol', 'Brain magnetic resonance imaging (MRI) examinations', 'placebo']","['level of matrix metallopeptidase', 'Aβ40 levels', 'brain volume', 'levels of plasma Aβ40 and Aβ42 and CSF Aβ40 and Aβ42', 'levels of Aβ40 in the blood and CSF', 'safety and tolerability']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0025543', 'cui_str': 'Metalloproteinase'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.257796,Aβ) protein is a major component of the extracellular plaque found in the brains of individuals with Alzheimer's disease (AD).,"[{'ForeName': 'Jiachen', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Neurology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zongshan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yongang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yaxing', 'Initials': 'Y', 'LastName': 'Gui', 'Affiliation': 'Department of Neurology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. YaxingGui@shsmu.edu.cn.'}]",Neurology and therapy,['10.1007/s40120-021-00271-2']
3224,34403019,Effect of Hypnosis on Anxiety: Results from a Randomized Controlled Trial with Women in Postmenopause.,"Anxiety is common, yet often under-treated, among women in postmenopause. This study examined the effect of a hypnotic intervention designed to reduce hot flashes, on anxiety levels of postmenopausal women. Anxiety was assessed using the State-Trait Anxiety Inventory, the Hospital Anxiety and Depression Scale-Anxiety subscale, and a visual analog scale. Additionally, hypnotizability was tested as a moderator of anxiety reductions. Significant reductions in anxiety were found from baseline to endpoint and follow-up and hypnosis was superior to the control condition. Additionally, ratings of Current Anxiety decreased from pre-session to post-session at each weekly visit and the pre-session scores reduced continuously. Hypnotizability was found to moderate anxiety reductions, but regardless of hypnotizability level participants, on average, experienced significant symptom improvement from baseline scores. These data provide initial support for the use of hypnosis to reduce symptoms of anxiety among postmenopausal women.Trial registration: This study was registered at ClinicalTrials.gov on February 11, 2011 under Identifier number NCT01293695 ( https://clinicaltrials.gov/ct2/show/NCT01293695?term=Elkins&cond=hot+flashes&draw=2&rank=2 ).",2021,Significant reductions in anxiety were found from baseline to endpoint and follow-up and hypnosis was superior to the control condition.,"['Women in Postmenopause', 'postmenopausal women']","['hypnotic intervention', 'Hypnosis']","['hot flashes', 'State-Trait Anxiety Inventory, the Hospital Anxiety and Depression Scale-Anxiety subscale, and a visual analog scale', 'anxiety', 'Anxiety', 'ratings of Current Anxiety', 'moderate anxiety reductions', 'Hypnotizability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206159', 'cui_str': 'Postmenopause'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}]","[{'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0231402', 'cui_str': 'Moderate anxiety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.120813,Significant reductions in anxiety were found from baseline to endpoint and follow-up and hypnosis was superior to the control condition.,"[{'ForeName': 'R Lynae', 'Initials': 'RL', 'LastName': 'Roberts', 'Affiliation': 'Department of Psychology & Neuroscience, Baylor University, 801 Washington Avenue, Suite 260, Waco, TX, 76701, USA. Lynae_Roberts@baylor.edu.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Rhodes', 'Affiliation': 'Department of Psychology & Neuroscience, Baylor University, 801 Washington Avenue, Suite 260, Waco, TX, 76701, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Elkins', 'Affiliation': 'Department of Psychology & Neuroscience, Baylor University, 801 Washington Avenue, Suite 260, Waco, TX, 76701, USA.'}]",Journal of clinical psychology in medical settings,['10.1007/s10880-021-09810-3']
3225,34402665,Reducing False-Positive Screening MRI Rate in Women with Extremely Dense Breasts Using Prediction Models Based on Data from the DENSE Trial.,"Background High breast density increases breast cancer risk and lowers mammographic sensitivity. Supplemental MRI screening improves cancer detection but increases the number of false-positive screenings. Thus, methods to distinguish true-positive MRI screening results from false-positive ones are needed. Purpose To build prediction models based on clinical characteristics and MRI findings to reduce the rate of false-positive screening MRI findings in women with extremely dense breasts. Materials and Methods Clinical characteristics and MRI findings in Dutch breast cancer screening participants (age range, 50-75 years) with positive first-round MRI screening results (Breast Imaging Reporting and Data System 3, 4, or 5) after a normal screening mammography with extremely dense breasts (Volpara density category 4) were prospectively collected within the randomized controlled Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial from December 2011 through November 2015. In this secondary analysis, prediction models were built using multivariable logistic regression analysis to distinguish true-positive MRI screening findings from false-positive ones. Results Among 454 women (median age, 52 years; interquartile range, 50-57 years) with a positive MRI result in a first supplemental MRI screening round, 79 were diagnosed with breast cancer (true-positive findings), and 375 had false-positive MRI results. The full prediction model (area under the receiver operating characteristics curve [AUC], 0.88; 95% CI: 0.84, 0.92), based on all collected clinical characteristics and MRI findings, could have prevented 45.5% (95% CI: 39.6, 51.5) of false-positive recalls and 21.3% (95% CI: 15.7, 28.3) of benign biopsies without missing any cancers. The model solely based on readily available MRI findings and age had a comparable performance (AUC, 0.84; 95% CI: 0.79, 0.88;  P  = .15) and could have prevented 35.5% (95% CI: 30.4, 41.1) of false-positive MRI screening results and 13.0% (95% CI: 8.8, 18.6) of benign biopsies. Conclusion Prediction models based on clinical characteristics and MRI findings may be useful to reduce the false-positive first-round screening MRI rate and benign biopsy rate in women with extremely dense breasts. Clinical trial registration no. NCT01315015 © RSNA, 2021  Online supplemental material is available for this article.  See also the editorial by Imbriaco in this issue.",2021,"The full prediction model (area under the receiver operating characteristics curve [AUC], 0.88; 95% CI: 0.84, 0.92), based on all collected clinical characteristics and MRI findings, could have prevented 45.5% (95% CI: 39.6, 51.5) of false-positive recalls and 21.3% (95% CI: 15.7, 28.3) of benign biopsies without missing any cancers.","['454 women (median age, 52 years; interquartile range, 50-57 years) with a positive MRI result in a first supplemental MRI screening round, 79 were diagnosed with breast cancer (true-positive findings), and 375 had false-positive MRI results', 'women with extremely dense breasts', 'Dutch breast cancer screening participants (age range, 50-75 years) with positive first-round MRI screening results (Breast Imaging Reporting and Data System 3, 4, or 5) after a normal screening mammography with extremely dense breasts (Volpara density category 4) were prospectively collected within the randomized controlled Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial from December 2011 through November 2015']","['Supplemental MRI screening', 'NCT01315015']","['Reducing False-Positive Screening MRI Rate', 'cancer detection', 'false-positive first-round screening MRI rate and benign biopsy rate']","[{'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1622900', 'cui_str': 'Data Systems'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",454.0,0.480796,"The full prediction model (area under the receiver operating characteristics curve [AUC], 0.88; 95% CI: 0.84, 0.92), based on all collected clinical characteristics and MRI findings, could have prevented 45.5% (95% CI: 39.6, 51.5) of false-positive recalls and 21.3% (95% CI: 15.7, 28.3) of benign biopsies without missing any cancers.","[{'ForeName': 'Bianca M', 'Initials': 'BM', 'LastName': 'den Dekker', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Marije F', 'Initials': 'MF', 'LastName': 'Bakker', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Stéphanie V', 'Initials': 'SV', 'LastName': 'de Lange', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Wouter B', 'Initials': 'WB', 'LastName': 'Veldhuis', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'van Diest', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Katya M', 'Initials': 'KM', 'LastName': 'Duvivier', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Marc B I', 'Initials': 'MBI', 'LastName': 'Lobbes', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Claudette E', 'Initials': 'CE', 'LastName': 'Loo', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Ritse M', 'Initials': 'RM', 'LastName': 'Mann', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Evelyn M', 'Initials': 'EM', 'LastName': 'Monninkhof', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Veltman', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Ruud M', 'Initials': 'RM', 'LastName': 'Pijnappel', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': 'Carla H', 'Initials': 'CH', 'LastName': 'van Gils', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'From the Department of Radiology (B.M.d.D., S.V.d.L., W.B.V., R.M.P.), Julius Center for Health Sciences and Primary Care (M.F.B., S.V.d.L., E.M.M., C.H.v.G.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and GROW School for Oncology and Developmental Biology, Maastricht University, and Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M.); Department of Radiology, Ziekenhuisgroep Twente, Almelo, the Netherlands (J.V.); and Dutch Expert Center for Screening, Nijmegen, the Netherlands (R.M.P.).'}]",Radiology,['10.1148/radiol.2021210325']
3226,34403141,Evaluating the efficacy of extracted squalene from seed oil in the form of microemulsion for the treatment of COVID-19: A clinical study.,"This study investigates the effect of the nanostructure of squalene in the form of microemulsion on COVID-19 patients. In this blinded clinical trial, a comparison was made between the efficacy of squalene treatment and controls. A total of 30 COVID-19 patients admitted to the emergency department, and the infection ward was equally allocated to case (n = 15) and control (n = 15) groups according to their age and underlying diseases. The baseline characteristics of subjects, including age, gender, time of treatment onset, underlying condition, white blood cells count, and lymphocyte count were similar (p < 0.05). Baseline laboratory tests and computed tomography (CT) scans were performed for the study groups. The treatment group received 5 mg of intravenous squalene twice a day and standard treatment for 6 days, while controls received only standard treatment. After 6 days of treatment, clinical and CT scan changes were evaluated and compared in intervention and control groups. The need for oxygen therapy (p = 0.020), 2 days of no fever (p = 0.025), cough alleviation (p = 0.010), and lung high-resolution computed tomography improvement (p = 0.033) were significantly different between cases and controls within 7 days of admission. No adverse effects were observed in the treatment group. Our data suggest that squalene could be considered as a potential treatment for COVID-19, and further studies are required to confirm the results.",2022,"The need for oxygen therapy (p=0.020), two days of no fever (p=0.025), cough alleviation (p=0.010), and lung HRCT improvement (p=0.033) were significantly different between cases and controls within seven days of admission.","['30 COVID-19 patients admitted to the emergency department, and infectious ward was equally allocated to case (n=15) and control (n=15) groups according to their age and underlying diseases', 'COVID-19 patients']","['intravenous squalene', 'extracted squalene from seed oil']","['adverse effects', 'cough alleviation', 'clinical and CT scan changes', 'lung HRCT improvement']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0038071', 'cui_str': 'Squalene'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]",30.0,0.032107,"The need for oxygen therapy (p=0.020), two days of no fever (p=0.025), cough alleviation (p=0.010), and lung HRCT improvement (p=0.033) were significantly different between cases and controls within seven days of admission.","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Ebrahimi', 'Affiliation': 'Cardiovascular Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Farhadian', 'Affiliation': 'Chemical Engineering Department, Faculty of Engineering, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Amiri', 'Affiliation': 'Emergency Medicine Department, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hataminia', 'Affiliation': 'Department of Medical Nanotechnology, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara Saffar', 'Initials': 'SS', 'LastName': 'Soflaei', 'Affiliation': 'Department of Modern Sciences & Technologies, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Karimi', 'Affiliation': 'Emergency Medicine Department, Birjand University of Medical Sciences, Birjand, Iran.'}]",Journal of medical virology,['10.1002/jmv.27273']
3227,34403133,Correction to: Effects of oral contraceptives on serum concentrations of adipokines and adiposity indices of women with polycystic ovary syndrome: a randomized controlled trial.,,2021,,['women with polycystic ovary syndrome'],['oral contraceptives'],['serum concentrations of adipokines and adiposity indices'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.14436,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No 24, Parvane Street, Yaman Street, Velenjak, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No 24, Parvane Street, Yaman Street, Velenjak, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nahidi', 'Affiliation': 'Department of Midwifery and Reproductive Health, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F Ramezani', 'Initials': 'FR', 'LastName': 'Tehrani', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No 24, Parvane Street, Yaman Street, Velenjak, Tehran, Iran. ramezani@endocrine.ac.ir.'}]",Journal of endocrinological investigation,['10.1007/s40618-021-01653-x']
3228,34406395,Effect of Sitagliptin on Islet Function in Pancreatic Insufficient Cystic Fibrosis With Abnormal Glucose Tolerance.,"PURPOSE


Impaired incretin secretion may contribute to the defective insulin secretion and abnormal glucose tolerance (AGT) that associate with worse clinical outcomes in pancreatic insufficient cystic fibrosis (PI-CF). The study objective was to test the hypothesis that dipeptidyl peptidase-4 (DPP-4) inhibitor-induced increases in intact incretin hormone [glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)] concentrations augment insulin secretion and glucagon suppression and lower postprandial glycemia in PI-CF with AGT.
METHODS


26 adults from Children's Hospital of Philadelphia and University of Pennsylvania CF Center with PI-CF and AGT [defined by oral glucose tolerance test glucose (mg/dL): early glucose intolerance (1-h ≥ 155 and 2-h < 140), impaired glucose tolerance (2-h ≥ 140 and < 200 mg/dL), or diabetes (2-h ≥ 200)] were randomized to a 6-month double-blind trial of DPP-4 inhibitor sitagliptin 100 mg daily or matched placebo; 24 completed the trial (n = 12 sitagliptin; n = 12 placebo). Main outcome measures were mixed-meal tolerance test (MMTT) responses for intact GLP-1 and GIP, insulin secretory rates (ISRs), glucagon suppression, and glycemia and glucose-potentiated arginine (GPA) test-derived measures of β- and α-cell function.
RESULTS


Following 6-months of sitagliptin vs placebo, MMTT intact GLP-1 and GIP responses increased (P < 0.001), ISR dynamics improved (P < 0.05), and glucagon suppression was modestly enhanced (P < 0.05) while GPA test responses for glucagon were lower. No improvements in glucose tolerance or β-cell sensitivity to glucose, including for second-phase insulin response, were found.
CONCLUSIONS


In glucose intolerant PI-CF, sitagliptin intervention augmented meal-related incretin responses with improved early insulin secretion and glucagon suppression without affecting postprandial glycemia.",2021,"No improvements in glucose tolerance or β-cell sensitivity to glucose, including for second-phase insulin response, were found.
","['Pancreatic Insufficient Cystic Fibrosis With Abnormal Glucose Tolerance', ""26 adults from Children's Hospital of Philadelphia and University of Pennsylvania CF Center with PI-CF and AGT [defined by oral glucose tolerance test glucose (mg/dL): early glucose intolerance (1-h\u2005≥\u2005155 and 2-h\u2005<\u2005140), impaired glucose tolerance ""]","['dipeptidyl peptidase-4 (DPP-4) inhibitor', '2-h\u2005≥\u2005140 and <\u2005200 mg/dL', 'DPP-4 inhibitor sitagliptin 100 mg daily or matched placebo', 'Sitagliptin', 'sitagliptin vs placebo', 'placebo']","['intact incretin hormone [glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP', 'mixed-meal tolerance test (MMTT) responses for intact GLP-1 and GIP, insulin secretory rates (ISRs), glucagon suppression, and glycemia and glucose-potentiated arginine (GPA) test-derived measures of β- and α-cell function', 'GIP responses', 'glucagon suppression', 'concentrations augment insulin secretion and glucagon suppression and lower postprandial glycemia', 'ISR dynamics', 'glucose tolerance or β-cell sensitivity to glucose, including for second-phase insulin response']","[{'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0235401', 'cui_str': 'Abnormal glucose tolerance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}]","[{'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0036542', 'cui_str': 'Secretory rate'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",26.0,0.154473,"No improvements in glucose tolerance or β-cell sensitivity to glucose, including for second-phase insulin response, were found.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kelly', 'Affiliation': ""Division of Endocrinology and Diabetes, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphias, PA, USA.""}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Stefanovski', 'Affiliation': 'Department of Biostatistics, University of Pennsylvania School of Veterinary Medicine, Kennett Square, PA, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Peleckis', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Nyirjesy', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jack N', 'Initials': 'JN', 'LastName': 'Eiel', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Aniket', 'Initials': 'A', 'LastName': 'Sidhaye', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Localio', 'Affiliation': 'Department of Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': 'Department of Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Diva D', 'Initials': 'DD', 'LastName': 'De Leon', 'Affiliation': ""Division of Endocrinology and Diabetes, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Hadjiliadis', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Rubenstein', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphias, PA, USA.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Rickels', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab365']
3229,34402161,Reasons for hospitalizations in patients with type 2 diabetes in the CANVAS programme: A secondary analysis.,"AIM


To determine the reasons for hospitalizations in the CANagliflozin cardioVascular Assessment Study (CANVAS) programme and the effects of the sodium-glucose co-transporter-2 inhibitor canagliflozin on hospitalization.
MATERIALS AND METHODS


A secondary analysis was performed on the CANVAS programme that included 10 142 participants with type 2 diabetes randomized to canagliflozin or placebo. The primary outcome was the rate of total (first plus all recurrent) all-cause hospitalizations (ACH). Secondary outcomes were total hospitalizations categorized by the Medical Dictionary for Regulatory Activities hierarchy at the system organ class level, reported by investigators at each centre. Outcomes were assessed using negative binomial models.
RESULTS


Of the 7115 hospitalizations reported, the most common reasons were cardiac disorders (23.7%), infections and infestations (15.0%), and nervous system disorders (9.0%). The rate of total ACH was lower in the canagliflozin group (n = 5795) compared with the placebo group (n = 4347): 197.9 versus 215.8 participants per 1000 patient-years, respectively (rate ratio [RR] 0.92; 95% confidence interval [CI] 0.86, 0.98). Canagliflozin reduced the rate of total hospitalizations because of cardiac disorders (RR 0.81; 95% CI 0.75, 0.88). There was no significant difference between the canagliflozin and placebo groups in the rates of total hospitalizations because of infections and infestations (RR 0.96; 95% CI 0.86, 1.02) or nervous system disorders (RR 0.96; 95% CI 0.88, 1.05).
CONCLUSIONS


In the CANVAS programme, the most common reasons for hospitalization were cardiac disorders, infections and infestations, and nervous system disorders. Canagliflozin, compared with placebo, reduced the rate of total ACH.",2021,"There was no significant difference between the canagliflozin and placebo groups in the rates of total hospitalizations due to infections and infestations (RR 0.96; 95% CI 0.86, 1.02) or nervous system disorders (RR 0.96; 95% CI 0.88, 1.05).
","['patients with type 2 diabetes mellitus in the CANVAS Program', '10,142 participants with type 2 diabetes mellitus randomized to']","['canagliflozin or placebo', 'sodium glucose co-transporter 2 inhibitor canagliflozin', 'canagliflozin', 'placebo', 'Canagliflozin']","['total hospitalizations categorized by the Medical Dictionary for Regulatory Activities hierarchy at the system organ class level', 'total (first plus all recurrent) all-cause hospitalization (ACH', 'rate of total ACH', 'rates of total hospitalizations due to infections and infestations', 'rate of total hospitalizations due to cardiac disorders', 'infections and infestations', 'nervous system disorders', 'cardiac disorders']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0012113', 'cui_str': 'Dictionary, Medical'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0460002', 'cui_str': 'Body system structure'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}]",10142.0,0.504969,"There was no significant difference between the canagliflozin and placebo groups in the rates of total hospitalizations due to infections and infestations (RR 0.96; 95% CI 0.86, 1.02) or nervous system disorders (RR 0.96; 95% CI 0.88, 1.05).
","[{'ForeName': 'Kent Y', 'Initials': 'KY', 'LastName': 'Feng', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'JingWei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Ianus', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Greg R', 'Initials': 'GR', 'LastName': 'Fulcher', 'Affiliation': 'Medicine, Royal North Shore Hospital and University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pfeifer', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College, University of Oxford, Oxford, UK.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, California, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14525']
3230,34406870,Randomized Phase III Trial Evaluating Radiation Following Surgical Excision for Good-Risk Ductal Carcinoma In Situ: Long-Term Report From NRG Oncology/RTOG 9804.,"PURPOSE


To our knowledge, NRG/RTOG 9804 is the only randomized trial to assess the impact of whole breast irradiation (radiation therapy [RT]) versus observation (OBS) in women with good-risk ductal carcinoma in situ (DCIS), following lumpectomy. Long-term results focusing on ipsilateral breast recurrence (IBR), the primary outcome, are presented here.
PATIENTS AND METHODS


Eligible patients underwent lumpectomy for DCIS that was mammogram detected, size ≤ 2.5 cm, final margins ≥ 3 mm, and low or intermediate nuclear grade. Consented patients were randomly assigned to RT or OBS. Tamoxifen use was optional. Cumulative incidence was used to estimate IBR, log-rank test and Gray's test to compare treatments, and Fine-Gray regression for hazard ratios (HRs).
RESULTS


A total of six hundred thirty-six women were randomly assigned from 1999 to 2006. Median age was 58 years and mean pathologic DCIS size was 0.60 cm. Intention to use tamoxifen was balanced between arms (69%); however, actual receipt of tamoxifen varied, 58% RT versus 66% OBS ( P  = .05). At 13.9 years' median follow-up, the 15-year cumulative incidence of IBR was 7.1% (95% CI, 4.0 to 11.5) with RT versus 15.1% (95% CI, 10.8 to 20.2) OBS ( P  = .0007; HR = 0.36; 95% CI, 0.20 to 0.66); and for invasive LR was 5.4% (95% CI, 2.7 to 9.5) RT versus 9.5% (95% CI, 6.0 to 13.9) OBS ( P  = .027; HR = 0.44; 95% CI, 0.21 to 0.91). On multivariable analysis, only RT (HR = 0.34; 95% CI, 0.19 to 0.64;  P  = .0007) and tamoxifen use (HR = 0.45; 95% CI, 0.25 to 0.78;  P  = .0047) were associated with reduced IBR.
CONCLUSION


RT significantly reduced all and invasive IBR for good-risk DCIS with durable results at 15 years. These results are not an absolute indication for RT but rather should inform shared patient-physician treatment decisions about ipsilateral breast risk reduction in the long term following lumpectomy.",2021,"Intention to use tamoxifen was balanced between arms (69%); however, actual receipt of tamoxifen varied, 58% RT versus 66% OBS ( P  = .05).","['Good-Risk Ductal Carcinoma', 'women with good-risk ductal carcinoma in situ (DCIS', 'Eligible patients underwent lumpectomy for DCIS that was mammogram detected, size ≤ 2.5 cm, final margins ≥ 3 mm, and low or intermediate nuclear grade', 'A total of six hundred thirty-six women were randomly assigned from 1999 to 2006']","['NRG', 'whole breast irradiation (radiation therapy [RT]) versus observation (OBS', 'tamoxifen', 'Radiation Following Surgical Excision', 'Tamoxifen', 'RT or OBS']","['invasive LR', '15-year cumulative incidence of IBR', 'ipsilateral breast recurrence (IBR', 'mean pathologic DCIS size']","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0728940', 'cui_str': 'Excision'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",636.0,0.0937387,"Intention to use tamoxifen was balanced between arms (69%); however, actual receipt of tamoxifen varied, 58% RT versus 66% OBS ( P  = .05).","[{'ForeName': 'Beryl', 'Initials': 'B', 'LastName': 'McCormick', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Winter', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Woodward', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Henry M', 'Initials': 'HM', 'LastName': 'Kuerer', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Sneige', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Rakovitch', 'Affiliation': 'Odette Cancer Centre-Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Smith', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Germain', 'Affiliation': ""CHU de Quebec-L'Hotel-Dieu de Quebec, Quebec City, QC, Canada.""}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Hartford', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, NH.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': ""O'Rourke"", 'Affiliation': 'Greenville CCOP-Cancer Centers of The Carolinas-Eastside, Greenville, SC.'}, {'ForeName': 'Eleanor M', 'Initials': 'EM', 'LastName': 'Walker', 'Affiliation': 'Henry Ford Hospital Rogel Cancer Center, Detroit, MI.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Strom', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Judith O', 'Initials': 'JO', 'LastName': 'Hopkins', 'Affiliation': 'Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, NC.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Anthony T', 'Initials': 'AT', 'LastName': 'Pu', 'Affiliation': 'Radiological Associates of Sacramento, Sacramento, CA.'}, {'ForeName': 'Kenneth N M', 'Initials': 'KNM', 'LastName': 'Sumida', 'Affiliation': 'University of Hawaii Cancer Center MBCCOP, Honolulu, HI.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Moughan', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Julia R', 'Initials': 'JR', 'LastName': 'White', 'Affiliation': 'Ohio State University Comprehensive Cancer Center, Columbus, OH.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01083']
3231,34399982,Effects of inorganic nitrate on ischaemia-reperfusion injury after coronary artery bypass surgery: a randomised controlled trial.,"BACKGROUND


Nitric oxide (NO) is an important signalling molecule in the cardiovascular system with protective properties in ischaemia-reperfusion injury. Inorganic nitrate, an oxidation product of endogenous NO production and a constituent in our diet, can be recycled back to bioactive NO. We investigated if preoperative administration of inorganic nitrate could reduce troponin T release and other plasma markers of injury to the heart, liver, kidney, and brain in patients undergoing cardiac surgery.
METHODS


This single-centre, randomised, double-blind, placebo-controlled trial included 82 patients undergoing coronary artery bypass surgery with cardiopulmonary bypass. Oral sodium nitrate (700 mg×2) or placebo (NaCl) were administered before surgery. Biomarkers of ischaemia-reperfusion injury and plasma nitrate and nitrite were collected before and up to 72 h after surgery. Troponin T release was our predefined primary endpoint and biomarkers of renal, liver, and brain injury were secondary endpoints.
RESULTS


Plasma concentrations of nitrate and nitrite were elevated in nitrate-treated patients compared with placebo. The 72-h release of troponin T did not differ between groups. Other plasma biomarkers of organ injury were also similar between groups. Blood loss was not a predefined outcome parameter, but perioperative bleeding was 18% less in nitrate-treated patients compared with controls.
CONCLUSION


Preoperative administration of inorganic nitrate did not influence troponin T release or other plasma biomarkers of organ injury in cardiac surgery.
CLINICAL TRIAL REGISTRATION


NCT01348971.",2021,The 72-h release of troponin T did not differ between groups.,"['patients undergoing cardiac surgery', 'ischaemia-reperfusion injury after coronary artery bypass surgery', '82 patients undergoing coronary artery bypass surgery with cardiopulmonary bypass']","['placebo', 'Inorganic nitrate', 'Oral sodium nitrate (700 mg×2) or placebo (NaCl', 'inorganic nitrate']","['troponin T release', 'Blood loss', 'Troponin T release', 'Plasma concentrations of nitrate and nitrite', 'biomarkers of renal, liver, and brain injury', 'plasma biomarkers of organ injury', 'perioperative bleeding', '72-h release of troponin T']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",82.0,0.328902,The 72-h release of troponin T did not differ between groups.,"[{'ForeName': 'Karin E', 'Initials': 'KE', 'LastName': 'Eriksson', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden; Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden. Electronic address: karin.eriksson.1@ki.se.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Eidhagen', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden; Stockholm Center for Spine Surgery (RKC), Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Liska', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden; Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Franco-Cereceda', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden; Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jon O', 'Initials': 'JO', 'LastName': 'Lundberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden; Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden. Electronic address: eddie.weitzberg@ki.se.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.06.046']
3232,34399063,"Efficacy and Safety of a Standardized Soy and Hop Extract on Menopausal Symptoms: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","Objectives:  Soy and hop extracts have been investigated as alternatives for hormone replacement therapy. However, their combined efficacy is not known. We investigated the efficacy and safety of a combined soy and hop extract on postmenopausal symptoms.  Design:  Double-blinded, randomized controlled trial.  Settings/Location:  Gynecological outpatient clinic of tertiary hospital.  Subjects:  Seventy-eight women with moderate or severe menopausal symptoms assessed as modified Kupperman Menopoausal Index (KMI) scores >20.  Interventions:  They received either a combined soy and hop extract ( n  = 38) or placebo ( n  = 40).  Outcome measures:  Menopausal symptoms were evaluated through self-reporting of modified Kupperman Menopausal Index (KMI) scores at baseline and after 6 and 12 weeks. We assessed serum levels of bone metabolism biomarkers, ultrasonographic parameters, hormone profiles, compliance, and safety.  Results:  After 12 weeks of the treatment, treatment group scores decreased by 20.61 points compared with 14.80 points in the placebo group ( p  < 0.05). Fatigue, paresthesia, arthralgia, and myalgia, palpitation and vaginal dryness significantly improved more in the treatment group compared with the placebo group after 12 weeks ( p  < 0.05). Urine N-telopeptide in participants ≥50 years in the treatment group showed a reduced increase. Endometrial thickness and hormonal profiles did not show significant changes in either group. No serious adverse events were reported.  Conclusion:  The results suggest that 190 mg of combined soy and hop extract is safe and effective for improvement of menopausal symptoms. CRIS No.: KCT0006019.",2021,"Fatigue, paresthesia, arthralgia, and myalgia, palpitation and vaginal dryness significantly improved more in the treatment group compared with the placebo group after 12 weeks ( p  < 0.05).","['Subjects:  Seventy-eight women with moderate or severe menopausal symptoms assessed as modified Kupperman Menopoausal Index (KMI) scores >20', 'Menopausal Symptoms']","['combined soy and hop extract ( n \u2009=\u200938) or placebo', 'combined soy and hop extract', 'Standardized Soy and Hop Extract', 'Placebo', 'placebo', 'Soy and hop extracts']","['postmenopausal symptoms', 'efficacy and safety', 'Efficacy and Safety', 'Endometrial thickness and hormonal profiles', 'safe and effective for improvement of menopausal symptoms', 'Outcome measures:  Menopausal symptoms were evaluated through self-reporting of modified Kupperman Menopausal Index (KMI) scores', 'serum levels of bone metabolism biomarkers, ultrasonographic parameters, hormone profiles, compliance, and safety', 'serious adverse events', 'Fatigue, paresthesia, arthralgia, and myalgia, palpitation and vaginal dryness']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0747771', 'cui_str': 'Postmenopausal syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness'}]",78.0,0.477357,"Fatigue, paresthesia, arthralgia, and myalgia, palpitation and vaginal dryness significantly improved more in the treatment group compared with the placebo group after 12 weeks ( p  < 0.05).","[{'ForeName': 'Hye In', 'Initials': 'HI', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Min Kyoung', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': ""Institute of Women's Life Medical Science, CHA University School of Medicine, Seoul, Republic of Korea.""}, {'ForeName': 'Inha', 'Initials': 'I', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jisun', 'Initials': 'J', 'LastName': 'Yun', 'Affiliation': 'Department of Obstetrics and Gynecology, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Eui Hyeok', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Seok Kyo', 'Initials': 'SK', 'LastName': 'Seo', 'Affiliation': 'Department of Obstetrics and Gynecology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2021.0027']
3233,34399062,Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial.,"BACKGROUND


Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but high-quality evidence is scarce.
OBJECTIVE


To assess the long-term efficacy of acupuncture for CP/CPPS.
DESIGN


Multicenter, randomized, sham-controlled trial. (ClinicalTrials.gov: NCT03213938).
SETTING


Ten tertiary hospitals in China.
PARTICIPANTS


Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture.
INTERVENTION


Twenty sessions of acupuncture or sham acupuncture over 8 weeks, with 24-week follow-up after treatment.
MEASUREMENTS


The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points.
RESULTS


A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group and 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0];  P  < 0.001). At week 32, the proportions were 61.5% (CI, 54.5% to 68.1%) in the acupuncture group and 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9];  P  < 0.001). Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported.
LIMITATION


Sham acupuncture might have had certain physiologic effects.
CONCLUSION


Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment.
PRIMARY FUNDING SOURCE


China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine.",2021,"Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment.
","['Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture', 'A total of 440 men (220 in each group) were recruited', 'Ten tertiary hospitals in China', 'Chronic Prostatitis/Chronic Pelvic Pain Syndrome ', 'chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS']","['acupuncture', 'Acupuncture', 'acupuncture or sham acupuncture']","['proportion of responders', 'adverse events', 'symptoms of moderate to severe CP/CPPS', 'serious adverse events', 'National Institutes of Health Chronic Prostatitis Symptom Index']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",440.0,0.690748,"Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment.
","[{'ForeName': 'Yuanjie', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (Y.L.).'}, {'ForeName': 'Baoyan', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).""}, {'ForeName': 'Kehua', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'ThedaCare Regional Medical Center - Appleton, Appleton, Wisconsin (K.Z.).'}, {'ForeName': 'Zenghui', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'Hengyang Hospital Affiliated to Hunan University of Chinese Medicine, Hengyang, China (Z.Y.).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'The First Hospital of Hunan University of Chinese Medicine, Changsha, China (W.Z.).'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China (W.F.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China (J.Y.).'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, China (N.L.).'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'China Academy of Chinese Medical Sciences, Beijing, China (L.H.).'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zang', 'Affiliation': 'Yantai Hospital of Traditional Chinese Medicine, Yantai, China (Z.Z.).'}, {'ForeName': 'Tongsheng', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': ""Shaanxi Provincial Hospital of Traditional Chinese Medicine, Xi'an, China (T.S.).""}, {'ForeName': 'Jianqiao', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China (J.F.).'}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Beijing Fengtai Hospital of Integrated Traditional and Western Medicine, Beijing, China (Y.D.).'}, {'ForeName': 'Zongshi', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).""}, {'ForeName': 'Hujie', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ""Xi'an TCM Brain Disease Hospital, Xi'an, China (H.S.).""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Dongfang Hospital Beijing University of Chinese Medicine, Beijing, China (H.H.).'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Luohu District Hospital of Traditional Chinese Medicine, Shenzhen, China (H.Z.).'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Mo', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine, Guiyang, China (Q.M.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).""}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).""}, {'ForeName': 'Xiaoxu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).""}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).""}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Pang', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).""}, {'ForeName': 'Xinlu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).""}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).""}]",Annals of internal medicine,['10.7326/M21-1814']
3234,34403780,"'eatNplay' - a rurally-tailored, family-based, telehealth intervention for childhood obesity: Protocol for a mixed-methods randomized newsletter controlled pilot study.","BACKGROUND


Childhood obesity disproportionately affects rural communities where access to pediatric weight control services is limited. Telehealth may facilitate access to these services.
OBJECTIVE


This paper describes the rationale, curriculum, and methodology for conducting a randomized controlled pilot trial of a rural, family-based, telehealth intervention that aims to improve weight-related behaviors among children, compared to monthly newsletters.
METHODS


A mixed-methods randomized design will randomly assign 44 rural families with one or more children aged 5 to 11 years identified as overweight or obese to an intervention or newsletter control group. The intervention group will attend 'eatNplay' group videoconferencing telehealth sessions, conducted weekly by a registered nurse and a motivational interviewing expert, to discuss diet, exercise, sleep, and peer group influences. The control group will receive newsletters covering these topics. Outcome measures at baseline, 12, and 26 weeks will assess 1) participant engagement and satisfaction with 'eatNplay'; 2) child's BMI, dietary behavior, physical activity, and sleep behavior; and 3) parent/guardians' self-reported beliefs, behaviors, attitudes, perceived stress, and perceived quality of life. Analyses will employ 1) thematic analysis of semi-structured parent/guardian interviews after follow-up to help refine the intervention (e.g., curriculum), and 2) linear mixed models to compare outcomes between groups pre- and post-intervention and reduce bias from unobserved variables. Results of this pilot study could refine methodology for conducting telehealth studies, acceptability of healthcare provider-involved recruitment, interdisciplinary team approach, and addressing childhood obesity in rural communities through telehealth.",2021,"Outcome measures at baseline, 12, and 26 weeks will assess 1) participant engagement and satisfaction with 'eatNplay'; 2) child's BMI, dietary behavior, physical activity, and sleep behavior; and 3) parent/guardians' self-reported beliefs, behaviors, attitudes, perceived stress, and perceived quality of life.",['44 rural families with one or more children aged 5 to 11\u202fyears identified as overweight or obese to an intervention or newsletter control group'],"[""intervention group will attend 'eatNplay' group videoconferencing telehealth sessions, conducted weekly by a registered nurse and a motivational interviewing expert, to discuss diet, exercise, sleep, and peer group influences"", ""eatNplay' - a rurally-tailored, family-based, telehealth intervention""]","[""1) participant engagement and satisfaction with 'eatNplay'; 2) child's BMI, dietary behavior, physical activity, and sleep behavior; and 3) parent/guardians' self-reported beliefs, behaviors, attitudes, perceived stress, and perceived quality of life""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",44.0,0.0446408,"Outcome measures at baseline, 12, and 26 weeks will assess 1) participant engagement and satisfaction with 'eatNplay'; 2) child's BMI, dietary behavior, physical activity, and sleep behavior; and 3) parent/guardians' self-reported beliefs, behaviors, attitudes, perceived stress, and perceived quality of life.","[{'ForeName': 'Allisandra G', 'Initials': 'AG', 'LastName': 'Kummer', 'Affiliation': 'School of Public Health, Department of Epidemiology and Biostatistics, Indiana University Bloomington, 1025 E. 7th Street #111, Bloomington, IN 47405, USA. Electronic address: alkummer@iu.edu.'}, {'ForeName': 'Mary Lynn', 'Initials': 'ML', 'LastName': 'Davis-Ajami', 'Affiliation': 'Indiana University School of Nursing, Indiana University-Purdue University Indianapolis, 600 Barnhill Dr. Indianapolis, IN 46202, USA. Electronic address: mdavisaj@iu.edu.'}, {'ForeName': 'Britney', 'Initials': 'B', 'LastName': 'Arce', 'Affiliation': 'School of Nursing, Indiana University Bloomington, 2631 E. Discovery Parkway, Bloomington, IN 47405, USA. Electronic address: barce@iu.edu.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hartlieb', 'Affiliation': 'Humanities, Health and Society, Florida International University College of Medicine, 11200 SW 8th Street, Miami, FL 33136, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Dickinson', 'Affiliation': 'School of Public Health, Department of Epidemiology and Biostatistics, Indiana University Bloomington, 1025 E. 7th Street #111, Bloomington, IN 47405, USA. Electronic address: sd3@indiana.edu.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Golzarri-Arroyo', 'Affiliation': 'School of Public Health, Department of Epidemiology and Biostatistics, Indiana University Bloomington, 1025 E. 7th Street #111, Bloomington, IN 47405, USA. Electronic address: lgolzarr@indiana.edu.'}, {'ForeName': 'Courtney O', 'Initials': 'CO', 'LastName': 'Olcott', 'Affiliation': 'Institute for Research on Addictive Behavior, School of Public Health, Indiana University Bloomington, 1033 E. 3rd Street, Bloomington, IN 47405, USA. Electronic address: coolcott@indiana.edu.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Faith', 'Affiliation': 'Graduate School of Education, Department of Counseling, School & Educational Psychology, University at Buffalo-State University of New York, 409 Baldy Hall, Buffalo, NY 14260, USA. Electronic address: mfaith@buffalo.edu.'}, {'ForeName': 'Wasantha P', 'Initials': 'WP', 'LastName': 'Jayawardene', 'Affiliation': 'Institute for Research on Addictive Behavior, School of Public Health, Indiana University Bloomington, 1033 E. 3rd Street, Bloomington, IN 47405, USA. Electronic address: wajayawa@indiana.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106542']
3235,34398796,Effect of Physician-Pharmacist Participation in the Management of Ambulatory Cancer Pain Through a Digital Health Platform: Randomized Controlled Trial.,"BACKGROUND


Self-management of ambulatory cancer pain is full of challenges. Motivated by the need for better pain management, we developed a WeChat-supported platform, Medication Housekeeper (MediHK), to enhance communication, optimize outcomes, and promote self-management in the home setting.
OBJECTIVE


We conducted a randomized controlled trial to assess whether the joint physician-pharmacist team through MediHK would provide better self-management of ambulatory patients with cancer pain.
METHODS


Patients were randomly assigned to either an intervention group or control group. During the 4-week study period, the pharmacist would send 24-hour pain diaries daily, adverse drug reaction (ADR) forms every 3 days, and the Brief Pain Inventory form every 15 days to patients in the intervention group via MediHK. If a patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician, who was then responsible for prescribing or adjusting pain medications. If no adjustments were needed, the pharmacist provided appropriate targeted education based on knowledge deficits. Patients in the control group received conventional care and did not receive reminders to fill out the forms. However, if the control group patients filled out a form via MediHK, the pain management team would review and respond in the same way as for the intervention group. The primary outcomes included pain intensity and pain interference in daily life. Secondary outcomes included patient-reported outcome measures, medication adherence, ADRs, and rehospitalization rates.
RESULTS


A total of 100 patients were included, with 51 (51%) in the intervention group and 49 (49%) in the control group. The worst pain scores, least pain scores, and average pain scores in the intervention group and the control group were statistically different, with median values of 4 (IQR 3-7) vs 7 (IQR 6-8; P=.001), 1 (IQR 0-2) vs 2 (IQR 1-3; P=.02), and 2 (IQR 2-4) vs 4 (IQR 3-5; P=.001), respectively, at the end of the study. The pain interference on patients' general activity, mood, relationships with others, and interests was reduced, but the difference was not statistically significant compared with the control group (Ps=.10-.76). The medication adherence rate increased from 43% to 63% in the intervention group, compared with an increase of 33% to 51% in the control group (P<.001). The overall number of ADRs increased at 4 weeks, and more ADRs were monitored in the intervention group (P=.003). Rehospitalization rates were similar between the 2 groups.
CONCLUSIONS


The joint physician-pharmacist team operating through MediHK improved pain management. This study supports the feasibility of integrating the internet into the self-management of cancer pain.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1900023075; https://www.chictr.org.cn/showproj.aspx?proj=36901.",2021,"The medication adherence rate increased from 43% to 63% in the intervention group, compared with an increase of 33% to 51% in the control group (P<.001).","['Patients', 'A total of 100 patients were included, with 51 (51%) in the intervention group and 49 (49%) in the control group', 'ambulatory patients with cancer pain']","['intervention group or control group', 'conventional care and did not receive reminders to fill out the forms', 'MediHK', 'Physician-Pharmacist Participation']","['medication adherence rate', 'pain intensity and pain interference in daily life', 'pain interference', 'ADRs', 'pain management', 'Brief Pain Inventory', 'Rehospitalization rates', 'worst pain scores, least pain scores, and average pain scores', '24-hour pain diaries daily, adverse drug reaction (ADR', 'overall number of ADRs', 'patient-reported outcome measures, medication adherence, ADRs, and rehospitalization rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0451366', 'cui_str': 'Pain diary'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}]",100.0,0.12327,"The medication adherence rate increased from 43% to 63% in the intervention group, compared with an increase of 33% to 51% in the control group (P<.001).","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'McLeod', 'Affiliation': 'Geriatric Oncology Consortium, Tampa, FL, United States.'}, {'ForeName': 'Ke-Ke', 'Initials': 'KK', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Wen-Hui', 'Initials': 'WH', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Hang-Xing', 'Initials': 'HX', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ya-Min', 'Initials': 'YM', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Shu-Sen', 'Initials': 'SS', 'LastName': 'Sun', 'Affiliation': 'Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Chen', 'Affiliation': 'Institute for Rational and Safe Medication Practices, National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Fang-Zhou', 'Initials': 'FZ', 'LastName': 'Liu', 'Affiliation': 'College of Information Science and Engineering, Hunan Normal University, Changsha, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, China.'}]",JMIR mHealth and uHealth,['10.2196/24555']
3236,34406128,Effect of 6% Hydroxyethyl Starch 130/0.4 on Inflammatory Response and Pulmonary Function in Patients Having Cardiac Surgery: A Randomized Clinical Trial.,"BACKGROUND


Cardiac surgery with cardiopulmonary bypass induces a profound inflammatory response that, when severe, can lead to multiorgan system dysfunction. Preliminary data suggest that administration of hydroxyethyl starch (HES) solutions may mitigate an inflammatory response and improve pulmonary function. Our goal was to examine the effect of 6% HES 130/0.4 versus 5% human albumin given for intravascular plasma volume replacement on the perioperative inflammatory response and pulmonary function in patients undergoing cardiac surgery.
METHODS


This was a subinvestigation of a blinded, parallel-group, randomized clinical trial of patients undergoing elective aortic valve replacement surgery at the Cleveland Clinic main campus, titled ""Effect of 6% Hydroxyethyl Starch 130/0.4 on Kidney and Haemostatic Function in Cardiac Surgical Patients."" Of 141 patients who were randomized to receive either 6% HES 130/0.4 or 5% human albumin for intraoperative plasma volume replacement, 135 patients were included in the data analysis (HES n = 66, albumin n = 69). We assessed the cardiopulmonary bypass-induced inflammatory response end points by comparing the 2 groups' serum concentrations of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and macrophage migration inhibitory factor (MIF), measured at baseline and at 1 and 24 hours after surgery. We also compared the 2 groups' postoperative pulmonary function end points, including the ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (Pao2:Fio2 ratio), dynamic lung compliance, oxygenation index (OI), and ventilation index (VI) at baseline, within 1 hour of arrival to the intensive care unit, and before tracheal extubation. The differences in the postoperative levels of inflammatory response and pulmonary function between the HES and albumin groups were assessed individually in linear mixed models.
RESULTS


Serum concentrations of the inflammatory markers (TNF-α, IL-6, MIF) were not significantly different (P ≥ .05) between patients who received 6% HES 130/0.4 or 5% albumin, and there was no significant heterogeneity of the estimated treatment effect over time (P ≥ .15). The results of pulmonary function parameters (Pao2:Fio2 ratio, dynamic compliance, OI, VI) were not significantly different (P ≥ .05) between groups, and there was no significant heterogeneity of the estimated treatment effect over time (P ≥ .15).
CONCLUSIONS


Our investigation found no significant difference in the concentrations of inflammatory markers and measures of pulmonary function between cardiac surgical patients who received 6% HES 130/0.4 versus 5% albumin.",2021,"Serum concentrations of the inflammatory markers (TNF-α, IL-6, MIF) were not significantly different (P ≥ .05) between patients who received 6% HES 130/0.4 or 5% albumin, and there was no significant heterogeneity of the estimated treatment effect over time (P ≥ .15).","['Patients', ' 135 patients were included in the data analysis (HES n = 66, albumin n = 69', '141 patients', 'patients undergoing elective aortic valve replacement surgery at the Cleveland Clinic main campus, titled ""Effect of 6', 'patients undergoing cardiac surgery', 'Cardiac Surgical Patients']","['HES 130/0.4 versus 5% human albumin', '6% HES 130/0.4 or 5% human albumin for intraoperative plasma volume replacement', 'Hydroxyethyl Starch', '6% Hydroxyethyl Starch', 'hydroxyethyl starch (HES) solutions']","['concentrations of inflammatory markers and measures of pulmonary function', 'Serum concentrations of the inflammatory markers (TNF-α, IL-6, MIF', 'postoperative levels of inflammatory response and pulmonary function', 'ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (Pao2:Fio2 ratio), dynamic lung compliance, oxygenation index (OI), and ventilation index (VI) at baseline, within 1 hour of arrival to the intensive care unit, and before tracheal extubation', 'pulmonary function parameters (Pao2:Fio2 ratio, dynamic compliance, OI, VI', 'serum concentrations of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and macrophage migration inhibitory factor (MIF', 'Inflammatory Response and Pulmonary Function', 'inflammatory response and improve pulmonary function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C3495434', 'cui_str': 'hydroxyethyl starch 130-0.4'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0024429', 'cui_str': 'Macrophage inhibitory factor'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0024112', 'cui_str': 'Lung compliance'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",135.0,0.203844,"Serum concentrations of the inflammatory markers (TNF-α, IL-6, MIF) were not significantly different (P ≥ .05) between patients who received 6% HES 130/0.4 or 5% albumin, and there was no significant heterogeneity of the estimated treatment effect over time (P ≥ .15).","[{'ForeName': 'Mee Jee', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'From the Anesthesiology Institute.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Tannenbaum', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute.'}, {'ForeName': 'Guangmei', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Department of Outcomes Research.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Outcomes Research.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Leung', 'Affiliation': 'Department of Outcomes Research.'}, {'ForeName': 'Hüseyin Oğuz', 'Initials': 'HO', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Outcomes Research.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Ince', 'Affiliation': 'Department of Outcomes Research.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Soltesz', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery.'}, {'ForeName': 'Andra E', 'Initials': 'AE', 'LastName': 'Duncan', 'Affiliation': 'Department of Outcomes Research.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005664']
3237,34407168,Efficacy and Nontarget Effects of a Spinosad-Based Larvicide in Minnesota Vernal Pools and Cattail Marshes.,"Larvicides that contain spinosad, a bacterial metabolite, are used to control mosquitoes in diverse aquatic habitats. These same habitats are home to other invertebrates, including Crustacea-fairy shrimp, isopods, and amphipods-and mollusks-fingernail clams and freshwater snails. A double-blind study evaluated the effects of Natular® G, a granular treatment containing spinosad, on spring Aedes spp. and nontarget invertebrates in vernal wetlands. Within 14 days after application, Natular G controlled larvae of spring Aedes by 53-84%, depending on species, but had no significant effects on numbers of fairy shrimp, fingernail clams, or freshwater snails. A second double-blind study evaluated effects on Coquillettidia perturbans and nontarget isopods and amphipods in cattail marshes. Treatment reduced emergence of Cq. perturbans by 25% but did not change numbers of isopods or amphipods. The 2 experiments indicate Natular G could be effective against spring Aedes in vernal wetlands, less so against Cq. perturbans in cattail marshes, and yet pose minimal risk to crustaceans and mollusks in either vernal wetlands or cattail marshes.",2021,"Within 14 days after application, Natular G controlled larvae of spring Aedes by 53-84%, depending on species, but had no significant effects on numbers of fairy shrimp, fingernail clams, or freshwater snails.",['cattail marshes'],"['Natular® G', 'Spinosad-Based Larvicide']","['numbers of fairy shrimp, fingernail clams, or freshwater snails', 'emergence of Cq']","[{'cui': 'C0331484', 'cui_str': 'Typha'}, {'cui': 'C1721089', 'cui_str': 'Marsh'}]","[{'cui': 'C0961781', 'cui_str': 'spinosad'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0998204', 'cui_str': 'Shrimp, Fairy'}, {'cui': 'C0222001', 'cui_str': 'Fingernails'}, {'cui': 'C0008894', 'cui_str': 'Clam'}, {'cui': 'C0016710', 'cui_str': 'Fresh water'}, {'cui': 'C0018882', 'cui_str': 'Helix'}]",,0.0522728,"Within 14 days after application, Natular G controlled larvae of spring Aedes by 53-84%, depending on species, but had no significant effects on numbers of fairy shrimp, fingernail clams, or freshwater snails.","[{'ForeName': 'Diann M', 'Initials': 'DM', 'LastName': 'Crane', 'Affiliation': ''}, {'ForeName': 'Carey A', 'Initials': 'CA', 'LastName': 'Lamere', 'Affiliation': ''}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Manweiler', 'Affiliation': ''}]",Journal of the American Mosquito Control Association,['10.2987/21-7021.1']
3238,34413344,A randomized-controlled neurofeedback trial in adult attention-deficit/hyperactivity disorder.,"Attention-deficit/hyperactivity disorder (ADHD) is a childhood onset disorder persisting into adulthood for a large proportion of cases. Neurofeedback (NF) has shown promising results in children with ADHD, but randomized controlled trials in adults with ADHD are scarce. We aimed to compare slow cortical potential (SCP)- and functional near-infrared spectroscopy (fNIRS) NF to a semi-active electromyography biofeedback (EMG-BF) control condition regarding changes in symptoms and the impact of learning success, as well as changes in neurophysiological parameters in an adult ADHD population. Patients were randomly assigned to SCP-NF (n = 26), fNIRS-NF (n = 21) or EMG-BF (n = 20). Outcome parameters were assessed over 30 training sessions (pre, intermediate, post) and at 6-months follow-up (FU) including 3 booster sessions. EEG was recorded during two auditory Go/NoGo paradigms assessing the P300 and contingent negative variation (CNV). fNIRS measurements were conducted during an n-back- as well as a Go/NoGo task. All three groups showed equally significant symptom improvements suggesting placebo- or non-specific effects on the primary outcome measure. Only when differentiating between learners and non-learners, fNIRS learners displayed stronger reduction of ADHD global scores compared to SCP non-learners at FU, and fNIRS learners showed specifically low impulsivity ratings. 30.8% in the SCP-NF and 61.9% of participants in the fNIRS-NF learned to regulate the respective NF target parameter. We conclude that some adults with ADHD learn to regulate SCP amplitudes and especially prefrontal hemodynamic activity during NF. We did not find any significant differences in outcome between groups when looking at the whole sample. When evaluating learners only, they demonstrate superior effects as compared to non-learners, which suggests specific effects in addition to non-specific effects of NF when learning occurs.",2021,"Only when differentiating between learners and non-learners, fNIRS learners displayed stronger reduction of ADHD global scores compared to SCP non-learners at FU, and fNIRS learners showed specifically low impulsivity ratings.","['children with ADHD', 'adult attention-deficit/hyperactivity disorder']","['Neurofeedback (NF', 'slow cortical potential (SCP)- and functional near-infrared spectroscopy (fNIRS) NF to a semi-active electromyography biofeedback (EMG-BF', 'SCP-NF', 'placebo', 'fNIRS-NF (n\u2009=\u200921) or EMG-BF']","['low impulsivity ratings', 'EEG', 'ADHD global scores', 'SCP amplitudes and especially prefrontal hemodynamic activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0330765,"Only when differentiating between learners and non-learners, fNIRS learners displayed stronger reduction of ADHD global scores compared to SCP non-learners at FU, and fNIRS learners showed specifically low impulsivity ratings.","[{'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Barth', 'Affiliation': 'Psychophysiology and Optical Imaging, Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076, Tübingen, Germany. beatrix.barth@med.uni-tuebingen.de.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Mayer-Carius', 'Affiliation': 'Institute for Medical Psychology and Behavioural Neurobiology, University of Tübingen, Silcherstr. 5, 72076, Tübingen, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Strehl', 'Affiliation': 'Institute for Medical Psychology and Behavioural Neurobiology, University of Tübingen, Silcherstr. 5, 72076, Tübingen, Germany.'}, {'ForeName': 'Sarah N', 'Initials': 'SN', 'LastName': 'Wyckoff', 'Affiliation': 'Institute for Medical Psychology and Behavioural Neurobiology, University of Tübingen, Silcherstr. 5, 72076, Tübingen, Germany.'}, {'ForeName': 'Florian B', 'Initials': 'FB', 'LastName': 'Haeussinger', 'Affiliation': 'Psychophysiology and Optical Imaging, Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Fallgatter', 'Affiliation': 'Psychophysiology and Optical Imaging, Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Ann-Christine', 'Initials': 'AC', 'LastName': 'Ehlis', 'Affiliation': 'Psychophysiology and Optical Imaging, Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076, Tübingen, Germany.'}]",Scientific reports,['10.1038/s41598-021-95928-1']
3239,34400362,The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension.,"INTRODUCTION


Over 100 million adults in the United States have hypertension. The DASH (Dietary Approaches to Stop Hypertension) eating pattern is an evidence-based first-line treatment option for hypertension; however, adherence to the DASH eating pattern at a population level remains low. To address this gap, we will implement Nourish, a randomized controlled efficacy trial that will leverage a commercially-available smartphone application and evidence-based behavior change principles to improve adherence to the DASH eating pattern among adults with hypertension.
METHODS


The Nourish trial is a two-arm, 12-month randomized control trial that will enroll adults (N = 300) with hypertension, defined as a systolic blood pressure of 120-159 mmHg; a diastolic blood pressure of 80-99 mmHg; and/or adults on blood pressure-lowering medication. Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure. Intervention components will include skills training, self-monitoring, personalized feedback, and responsive coaching. The primary outcome of the trial is 6-month changes in adherence to the DASH eating pattern, as measured by 24-h dietary recalls.
DISCUSSION


Millions of Americans remain in need of effective behavioral interventions to manage and improve their hypertension and its adverse consequences. The ubiquity of smartphones offers a promising approach to disseminate the DASH eating pattern. By leveraging these widely used smartphone applications, combined with evidence-based behavior change principles and the DASH eating plan, Nourish will demonstrate the effectiveness of a digital health intervention to improve DASH adherence, and ultimately, to reduce blood pressure. Trial Number: NCT03875.",2021,"Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure.","['enroll adults (N\u202f=\u202f300) with hypertension, defined as a systolic blood pressure of 120-159\u202fmmHg; a diastolic blood pressure of 80-99\u202fmmHg; and/or adults on blood pressure-lowering medication', '100 million adults in the United States have hypertension', 'adults with hypertension']","['skills training, self-monitoring, personalized feedback, and responsive coaching', 'digital health intervention']","['DASH eating pattern adherence and blood pressure', 'blood pressure', '6-month changes in adherence to the DASH eating pattern, as measured by 24-h dietary recalls']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",300.0,0.0519072,"Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure.","[{'ForeName': 'Hailey N', 'Initials': 'HN', 'LastName': 'Miller', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, United States of America; Duke Global Digital Health Science Center, Duke University, Durham, NC, United States of America. Electronic address: hm189@duke.edu.'}, {'ForeName': 'Miriam B', 'Initials': 'MB', 'LastName': 'Berger', 'Affiliation': 'Duke Global Digital Health Science Center, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Askew', 'Affiliation': 'Duke Global Digital Health Science Center, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Kay', 'Affiliation': 'Duke Global Digital Health Science Center, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Hopkins', 'Affiliation': 'Duke Global Digital Health Science Center, Duke University, Durham, NC, United States of America; Department of Psychology and Neuroscience, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Meghana Sai', 'Initials': 'MS', 'LastName': 'Iragavarapu', 'Affiliation': 'Duke Global Digital Health Science Center, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'de Leon', 'Affiliation': 'Duke Global Digital Health Science Center, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Freed', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, United States of America; Duke Global Digital Health Science Center, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Cherie N', 'Initials': 'CN', 'LastName': 'Barnes', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, United States of America; Duke Global Digital Health Science Center, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Crystal C', 'Initials': 'CC', 'LastName': 'Tyson', 'Affiliation': 'School of Medicine, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Svetkey', 'Affiliation': 'School of Medicine, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Bennett', 'Affiliation': 'Duke Global Digital Health Science Center, Duke University, Durham, NC, United States of America; Department of Psychology and Neuroscience, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Dori M', 'Initials': 'DM', 'LastName': 'Steinberg', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, United States of America; Equip Health, LLC, San Diego, CA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106539']
3240,34404828,Continuous subcutaneous insulin infusion alters microRNA expression and glycaemic variability in children with type 1 diabetes.,"To determine whether continuous subcutaneous insulin infusion (CSII) vs. multiple daily injections (MDI) therapy from near-diagnosis of type 1 diabetes is associated with reduced glycaemic variability (GV) and altered microRNA (miRNAs) expression. Adolescents (74% male) within 3-months of diabetes diagnosis (n = 27) were randomized to CSII (n = 12) or MDI. HbA1c, 1-5-Anhydroglucitol (1,5-AG), high sensitivity C-peptide and a custom TaqMan qPCR panel of 52 miRNAs were measured at baseline and follow-up (median (LQ-UQ); 535 (519-563) days). There were no significant differences between groups in baseline or follow-up HbA1c or C-peptide, nor baseline miRNAs. Mean ± SD 1,5-AG improved with CSII vs. MDI (3.1 ± 4.1 vs. - 2.2 ± - 7.0 mg/ml respectively, P = 0.029). On follow-up 11 miRNAs associated with diabetes vascular complications had altered expression in CSII-users. Early CSII vs. MDI use is associated with lower GV and less adverse vascular-related miRNAs. Relationships with future complications are of interest.",2021,"There were no significant differences between groups in baseline or follow-up HbA1c or C-peptide, nor baseline miRNAs.","['Adolescents (74% male) within 3-months of diabetes diagnosis (n\u2009=\u200927', 'children with type 1 diabetes']","['Continuous subcutaneous insulin infusion', 'CSII', 'continuous subcutaneous insulin infusion (CSII) vs. multiple daily injections (MDI) therapy', 'MDI']","['microRNA expression and glycaemic variability', 'Mean\u2009±\u2009SD 1,5-AG', 'HbA1c, 1-5-Anhydroglucitol (1,5-AG), high sensitivity C-peptide and a custom TaqMan qPCR panel of 52 miRNAs', 'glycaemic variability (GV) and altered microRNA (miRNAs) expression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019728', 'cui_str': 'HLA-A antigen'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.13289,"There were no significant differences between groups in baseline or follow-up HbA1c or C-peptide, nor baseline miRNAs.","[{'ForeName': 'Emma S', 'Initials': 'ES', 'LastName': 'Scott', 'Affiliation': 'NHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Andrzej S', 'Initials': 'AS', 'LastName': 'Januszewski', 'Affiliation': 'NHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Luke M', 'Initials': 'LM', 'LastName': 'Carroll', 'Affiliation': 'NHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Fulcher', 'Affiliation': 'Department of Endocrinology and Diabetes, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Mugdha V', 'Initials': 'MV', 'LastName': 'Joglekar', 'Affiliation': 'NHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Anandwardhan A', 'Initials': 'AA', 'LastName': 'Hardikar', 'Affiliation': 'NHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': 'University of Western Australia, Perth, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Davis', 'Affiliation': 'University of Western Australia, Perth, Australia.'}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, Australia. alicia.jenkins@ctc.usyd.edu.au.'}]",Scientific reports,['10.1038/s41598-021-95824-8']
3241,34404743,Progression of Clinical Features in Lewy Body Dementia Can Be Detected Over 6 Months.,"OBJECTIVE


This study aimed to quantify the trajectory and magnitude of change of the key clinical features and corresponding symptom domains of dementia with Lewy bodies (DLB) and Parkinson disease dementia (PDD), including global cognition, parkinsonism, recurrent visual hallucinations, cognitive fluctuations, and sleep disturbance.
METHODS


One hundred sixteen patients with Lewy body dementia (DLB = 72, PDD = 44) underwent assessment at baseline and 3 and 6 months as part of a prospective multicenter randomized controlled trial. Linear mixed models were constructed for core outcome measures using the Mini-Mental State Examination (MMSE), motor section of the Unified Parkinson's Disease Rating Scale (UPDRS-III), Dementia Cognitive Fluctuations Scale (DCFS), and Neuropsychiatric Inventory (NPI).
RESULTS


Within the time frame of our study (6 months), we were able to identify a significant cognitive decline of 1.3 points on the MMSE ( p  = 0.002) and significant worsening of motor parkinsonism with an increase in UPDRS-III score of 3.2 points ( p  = 0.018). Fluctuation severity also increased using the DCFS with a 6-month change in score of 1.3 points ( p  = 0.001). Uniquely, a signal for increased severity of sleep symptoms of 1.2 points (NPI-sleep) was also detectable ( p  = 0.04). Significant changes in neuropsychiatric symptoms were not detected. There was no difference in rates of change of scores between DLB and PDD.
DISCUSSION


Clinically significant rates of change in core clinical features can be detected and quantified in Lewy body dementia over a relatively short period (6 months) using common clinical instruments and thus may be useful as clinical endpoints for therapeutic trials of disease-modifying and symptomatic agents.",2021,Fluctuation severity also increased using the DCFS with a 6 month change in score of 1.3 points (P=0.001).,"['116 patients with Lewy body dementia (DLB=72, PDD=44', ""Dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD""]",[],"['severity of sleep symptoms', 'neuropsychiatric symptoms', 'UPDRS-III score', ""Mini-Mental State Examination (MMSE), motor section of the Unified Parkinson's disease rating scale (UPDRS-III), Dementia Cognitive Fluctuations Scale (DCFS) and the Neuropsychiatric Inventory (NPI"", 'Fluctuation severity']","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",116.0,0.190055,Fluctuation severity also increased using the DCFS with a 6 month change in score of 1.3 points (P=0.001).,"[{'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Matar', 'Affiliation': ""From the Department of Psychiatry (E.M., S.R.W., A.S., J.T.O.) and MRC Biostatistics Unit (S.R.W.), University of Cambridge, UK; Forefront Parkinson's Disease Research Clinic (E.M., G.M.H., S.J.G.L.) and Brain and Mind Centre (E.M., G.M.H., S.J.G.L.), Faculty of Medicine and Health, University of Sydney, Australia; Newcastle Translational and Clinical Research Institute (J.-P.T., A.T., I.G.M.), Campus for Ageing and Vitality, Newcastle University, Newcastle Upon Tyne; and Centre for Public Health (J.P.M.K.), Queen's University Belfast, UK. elie.matar@sydney.edu.au.""}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'White', 'Affiliation': ""From the Department of Psychiatry (E.M., S.R.W., A.S., J.T.O.) and MRC Biostatistics Unit (S.R.W.), University of Cambridge, UK; Forefront Parkinson's Disease Research Clinic (E.M., G.M.H., S.J.G.L.) and Brain and Mind Centre (E.M., G.M.H., S.J.G.L.), Faculty of Medicine and Health, University of Sydney, Australia; Newcastle Translational and Clinical Research Institute (J.-P.T., A.T., I.G.M.), Campus for Ageing and Vitality, Newcastle University, Newcastle Upon Tyne; and Centre for Public Health (J.P.M.K.), Queen's University Belfast, UK.""}, {'ForeName': 'John-Paul', 'Initials': 'JP', 'LastName': 'Taylor', 'Affiliation': ""From the Department of Psychiatry (E.M., S.R.W., A.S., J.T.O.) and MRC Biostatistics Unit (S.R.W.), University of Cambridge, UK; Forefront Parkinson's Disease Research Clinic (E.M., G.M.H., S.J.G.L.) and Brain and Mind Centre (E.M., G.M.H., S.J.G.L.), Faculty of Medicine and Health, University of Sydney, Australia; Newcastle Translational and Clinical Research Institute (J.-P.T., A.T., I.G.M.), Campus for Ageing and Vitality, Newcastle University, Newcastle Upon Tyne; and Centre for Public Health (J.P.M.K.), Queen's University Belfast, UK.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': ""From the Department of Psychiatry (E.M., S.R.W., A.S., J.T.O.) and MRC Biostatistics Unit (S.R.W.), University of Cambridge, UK; Forefront Parkinson's Disease Research Clinic (E.M., G.M.H., S.J.G.L.) and Brain and Mind Centre (E.M., G.M.H., S.J.G.L.), Faculty of Medicine and Health, University of Sydney, Australia; Newcastle Translational and Clinical Research Institute (J.-P.T., A.T., I.G.M.), Campus for Ageing and Vitality, Newcastle University, Newcastle Upon Tyne; and Centre for Public Health (J.P.M.K.), Queen's University Belfast, UK.""}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'McKeith', 'Affiliation': ""From the Department of Psychiatry (E.M., S.R.W., A.S., J.T.O.) and MRC Biostatistics Unit (S.R.W.), University of Cambridge, UK; Forefront Parkinson's Disease Research Clinic (E.M., G.M.H., S.J.G.L.) and Brain and Mind Centre (E.M., G.M.H., S.J.G.L.), Faculty of Medicine and Health, University of Sydney, Australia; Newcastle Translational and Clinical Research Institute (J.-P.T., A.T., I.G.M.), Campus for Ageing and Vitality, Newcastle University, Newcastle Upon Tyne; and Centre for Public Health (J.P.M.K.), Queen's University Belfast, UK.""}, {'ForeName': 'Joseph P M', 'Initials': 'JPM', 'LastName': 'Kane', 'Affiliation': ""From the Department of Psychiatry (E.M., S.R.W., A.S., J.T.O.) and MRC Biostatistics Unit (S.R.W.), University of Cambridge, UK; Forefront Parkinson's Disease Research Clinic (E.M., G.M.H., S.J.G.L.) and Brain and Mind Centre (E.M., G.M.H., S.J.G.L.), Faculty of Medicine and Health, University of Sydney, Australia; Newcastle Translational and Clinical Research Institute (J.-P.T., A.T., I.G.M.), Campus for Ageing and Vitality, Newcastle University, Newcastle Upon Tyne; and Centre for Public Health (J.P.M.K.), Queen's University Belfast, UK.""}, {'ForeName': 'Ajenthan', 'Initials': 'A', 'LastName': 'Surendranathan', 'Affiliation': ""From the Department of Psychiatry (E.M., S.R.W., A.S., J.T.O.) and MRC Biostatistics Unit (S.R.W.), University of Cambridge, UK; Forefront Parkinson's Disease Research Clinic (E.M., G.M.H., S.J.G.L.) and Brain and Mind Centre (E.M., G.M.H., S.J.G.L.), Faculty of Medicine and Health, University of Sydney, Australia; Newcastle Translational and Clinical Research Institute (J.-P.T., A.T., I.G.M.), Campus for Ageing and Vitality, Newcastle University, Newcastle Upon Tyne; and Centre for Public Health (J.P.M.K.), Queen's University Belfast, UK.""}, {'ForeName': 'Glenda M', 'Initials': 'GM', 'LastName': 'Halliday', 'Affiliation': ""From the Department of Psychiatry (E.M., S.R.W., A.S., J.T.O.) and MRC Biostatistics Unit (S.R.W.), University of Cambridge, UK; Forefront Parkinson's Disease Research Clinic (E.M., G.M.H., S.J.G.L.) and Brain and Mind Centre (E.M., G.M.H., S.J.G.L.), Faculty of Medicine and Health, University of Sydney, Australia; Newcastle Translational and Clinical Research Institute (J.-P.T., A.T., I.G.M.), Campus for Ageing and Vitality, Newcastle University, Newcastle Upon Tyne; and Centre for Public Health (J.P.M.K.), Queen's University Belfast, UK.""}, {'ForeName': 'Simon J G', 'Initials': 'SJG', 'LastName': 'Lewis', 'Affiliation': ""From the Department of Psychiatry (E.M., S.R.W., A.S., J.T.O.) and MRC Biostatistics Unit (S.R.W.), University of Cambridge, UK; Forefront Parkinson's Disease Research Clinic (E.M., G.M.H., S.J.G.L.) and Brain and Mind Centre (E.M., G.M.H., S.J.G.L.), Faculty of Medicine and Health, University of Sydney, Australia; Newcastle Translational and Clinical Research Institute (J.-P.T., A.T., I.G.M.), Campus for Ageing and Vitality, Newcastle University, Newcastle Upon Tyne; and Centre for Public Health (J.P.M.K.), Queen's University Belfast, UK.""}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': ""O'Brien"", 'Affiliation': ""From the Department of Psychiatry (E.M., S.R.W., A.S., J.T.O.) and MRC Biostatistics Unit (S.R.W.), University of Cambridge, UK; Forefront Parkinson's Disease Research Clinic (E.M., G.M.H., S.J.G.L.) and Brain and Mind Centre (E.M., G.M.H., S.J.G.L.), Faculty of Medicine and Health, University of Sydney, Australia; Newcastle Translational and Clinical Research Institute (J.-P.T., A.T., I.G.M.), Campus for Ageing and Vitality, Newcastle University, Newcastle Upon Tyne; and Centre for Public Health (J.P.M.K.), Queen's University Belfast, UK.""}]",Neurology,['10.1212/WNL.0000000000012450']
3242,34409620,Ephedrine pretreatment for nasotracheal intubation-related epistaxis in maxillofacial surgery with sufficient lubrication: A randomized clinical trial.,"WHAT IS KNOWN AND OBJECTIVE


Prior to nasotracheal intubation (NTI), topical nasal vasoconstrictors are used to prevent NTI-related epistaxis (NTIRE). Since we learned that there is no significant increase in NTIRE among hypertensive patients undergoing NTI with adequate lubrication but without vasoconstrictors, we initiated this randomized controlled study to assess the necessity of vasoconstrictor use in reducing NTIRE.
METHODS


Patients with the American Society of Anesthesiologists Physical Status Classification 1 and normal coagulation function, planned to undergo maxillofacial surgery with NTI were enrolled. Patients were randomly (1:1) assigned to each of the treatment groups: nasal treatment using pure oxybuprocaine gel with adequate lubrication (group G) or 1% ephedrine in addition to oxybuprocaine gel with adequate lubrication (group EG). In addition, the incidence and severity of NTIRE and intubation adjustments were studied.
RESULTS


A total of 844 patients, 429 and 415 (groups G and EG, respectively), were included in the analysis. No significant differences were observed in the NTIRE incidence rates in groups G (28%) and EG (27%; p = 0.75, relative risk [RR] = 0.95, 95% confidence interval [CI] 0.70-1.29). No significant differences in the NTIRE incidence rates between the two nostrils were observed in both groups (group G: left, 27.9% vs. right, 28% [p = 0.98, RR = 1.01, 95% CI 0.67-1.51]; group EG: left, 25.8% vs. right, 27.9% [p = 0.63, RR = 1.12, 95% CI 0.72-1.73]. No significant difference was observed in the severity of NTIRE (p = 0.74). In case of difficult advancement of the endotracheal tube, NTIRE incidence was 71% vs. 12% with smooth intubation (p < 0.01, RR = 18.33, 95% CI 12.55-26.77).
WHAT IS NEW AND CONCLUSION


Well-lubricated nasotracheal intubation does not require pretreatment with ephedrine to reduce NTIRE.",2021,"No significant differences in the NTIRE incidence rates between the two nostrils were observed in both groups (group G: left, 27.9% vs. right, 28% [p = 0.98, RR = ","['Patients with the American Society of Anesthesiologists Physical Status Classification 1 and normal coagulation function, planned to undergo maxillofacial surgery with NTI were enrolled', 'A total of 844 patients, 429 and 415 (groups G and EG, respectively), were included in the analysis', 'hypertensive patients undergoing NTI with adequate lubrication but without vasoconstrictors', 'nasotracheal intubation-related epistaxis in maxillofacial surgery with sufficient lubrication']","['ephedrine', 'nasal treatment using pure oxybuprocaine gel with adequate lubrication (group G) or 1% ephedrine in addition to oxybuprocaine gel with adequate lubrication', 'Ephedrine']","['NTIRE incidence rates', 'NTIRE', 'severity of NTIRE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450990', 'cui_str': 'American Society of Anesthesiologists physical status classification'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0441841', 'cui_str': 'Group G'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0053114', 'cui_str': 'Benoxinate'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",844.0,0.181287,"No significant differences in the NTIRE incidence rates between the two nostrils were observed in both groups (group G: left, 27.9% vs. right, 28% [p = 0.98, RR = ","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Quanle', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Deng', 'Initials': 'D', 'LastName': 'Xiaoming', 'Affiliation': 'Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guihua', 'Initials': 'G', 'LastName': 'Xiang', 'Affiliation': 'Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lingxin', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13509']
3243,34409492,Tranexamic acid attenuates early post-operative systemic inflammatory response and nutritional loss and avoids reduction of fibrinogen in total hip arthroplasty within an enhanced recovery after surgery pathway.,"PURPOSE


Total hip arthroplasty (THA) is an intervention with significant inflammatory response. The impact of additional doses of tranexamic acid (TXA) on inflammatory response, trauma and nutrition parameters, and coagulation and fibrinolysis changes has rarely been reported.
METHODS


A prospective double-blind randomized trial was performed on elective primary THA. Ninety-nine adult patients were recruited consecutively from 2019 to 2020. They were randomized to receive single-dose of TXA before incision, another dose of TXA at three hours post-operatively, or another two doses of TXA at three and six hours  post-operatively. The primary outcomes included changes in white blood cell (WBC) counts, creatine kinase (CK), haemoglobin(Hb), and albumin(Alb); the secondary outcomes included coagulation and fibrinolysis parameters.
RESULTS


Compared with single-dose TXA, patients received three dose TXA had significantly reduced WBC counts and fibrinogen/fibrin degradation product (FDP) levels, increased albumin and fibrinogen levels, and prolonged PT on post-operative day (POD) three. Though patients received three dose TXA had a tendency that increased Hb, decreased CK, reduced D-D, and prolonged APTT on POD3, it is not statistically significant. And the other measured outcomes on POD1 and POD2W shared a similar statistical result, except PT. The PT is significantly prolonged on POD2W in three dose group compared with single dose.
CONCLUSION


Three-dose TXA contribute to attenuate early post-operative systemic inflammatory response and nutritional loss, increase fibrinogen, reduce FDP levels, and prolong PT in THA patients within an ERAS pathway, which may associate with reduced early post-operative haemorrhagic tendency, thrombosis risks, and hypercoagulability.",2021,"TXA had significantly reduced WBC counts and fibrinogen/fibrin degradation product (FDP) levels, increased albumin and fibrinogen levels, and prolonged PT on post-operative day (POD) three.",['Ninety-nine adult patients were recruited consecutively from 2019 to 2020'],"['Total hip arthroplasty (THA', 'Tranexamic acid', 'TXA', 'tranexamic acid (TXA']","['inflammatory response, trauma and nutrition parameters, and coagulation and fibrinolysis changes', 'CK, reduced D-D, and prolonged APTT on POD3', 'FDP levels', 'WBC counts and fibrinogen/fibrin degradation product (FDP) levels, increased albumin and fibrinogen levels', 'changes in white blood cell (WBC) counts, creatine kinase (CK), haemoglobin(Hb), and albumin(Alb); the secondary outcomes included coagulation and fibrinolysis parameters']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0112081', 'cui_str': 'D-D mixture'}, {'cui': 'C0240671', 'cui_str': 'Partial thromboplastin time increased'}, {'cui': 'C0200453', 'cui_str': 'Fibrin-fibrinogen split products assay'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0163275', 'cui_str': 'Fibrin degradation product'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0740469', 'cui_str': 'Increased albumin'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",99.0,0.179066,"TXA had significantly reduced WBC counts and fibrinogen/fibrin degradation product (FDP) levels, increased albumin and fibrinogen levels, and prolonged PT on post-operative day (POD) three.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Changjun', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Xin', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Luo', 'Initials': 'L', 'LastName': 'Yue', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Chengcheng', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Qiuru', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Qianhao', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Pengde', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China. kangpengde1969@163.com.""}]",International orthopaedics,['10.1007/s00264-021-05182-3']
3244,34413391,Effect of aerobic and resistance exercise on the mitochondrial peptide MOTS-c in Hispanic and Non-Hispanic White breast cancer survivors.,"MOTS-c is a mitochondrial derived peptide with exercise mimetic activity that elicits beneficial effects on metabolism and exercise capacity. Furthermore, MOTS-c effects in humans are affected by race, potentially via ethnic-specific mtDNA variations. Women treated for breast cancer are at an increased risk for cardiovascular disease, diabetes and obesity, due to side effects of cancer-treatments. We conducted a secondary analysis of the effects of a 16-week aerobic and resistance exercise intervention on MOTS-c in Hispanic and Non-Hispanic White breast cancer survivors (BCS). BCS (Stage I-III) were randomized to exercise or standard care. The intervention promoted aerobic and resistance exercise for 16 weeks. MOTS-c was analyzed in fasting plasma using an in-house ELISA. Within and between group differences were assessed by paired t-test and repeated measures ANOVA. Pearson's correlation was computed to assess the association between MOTS-c and metabolic biomarkers at baseline and post-exercise. Twenty-five Hispanic-BCS and 24 non-Hispanic White BCS were included. Hispanic BCS were younger, of greater adiposity, had higher stage cancers, and had worse metabolic profiles at baseline compared to non-Hispanic White BCS (p < 0.001). Post-exercise, MOTS-c levels significantly increased when compared to baseline and the usual care group among non-Hispanic White BCS (p < 0.01) but not among Hispanic breast cancer survivors (p > 0.01). Post-exercise levels of MOTS-c among non-Hispanic White BCS were significantly associated with reductions in fat mass, body weight, HOMA-IR, CRP, and an increase in lean mass (p < 0.01). A 16-week aerobic and resistance intervention increased MOTS-c levels among non-Hispanic White BCS. Trial registration: This trial is registered on ClinicalTrials.gov: NCT01140282 as of June 9, 2010. https://clinicaltrials.gov/ct2/show/NCT01140282 .",2021,"Post-exercise levels of MOTS-c among non-Hispanic White BCS were significantly associated with reductions in fat mass, body weight, HOMA-IR, CRP, and an increase in lean mass (p < 0.01).","['Twenty-five Hispanic-BCS and 24 non-Hispanic White BCS', 'Hispanic and Non-Hispanic White breast cancer survivors', 'non-Hispanic White BCS', 'Hispanic and Non-Hispanic White breast cancer survivors (BCS']","['aerobic and resistance exercise intervention', 'aerobic and resistance exercise', 'aerobic and resistance intervention']","['aerobic and resistance exercise', 'Post-exercise, MOTS-c levels', 'MOTS-c levels', 'fat mass, body weight, HOMA-IR, CRP', 'lean mass', 'metabolic profiles']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",,0.146256,"Post-exercise levels of MOTS-c among non-Hispanic White BCS were significantly associated with reductions in fat mass, body weight, HOMA-IR, CRP, and an increase in lean mass (p < 0.01).","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Dieli-Conwright', 'Affiliation': 'Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, 375 Longwood Avenue, Boston, MA, 02215, USA. ChristinaM_Dieli-Conwright@DFCI.Harvard.edu.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Sami', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California (USC), Los Angeles, CA, 90033, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Norris', 'Affiliation': 'Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, 375 Longwood Avenue, Boston, MA, 02215, USA.'}, {'ForeName': 'Junxiang', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Leonard Davis School of Gerontology, USC, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kumagai', 'Affiliation': 'Leonard Davis School of Gerontology, USC, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'Su-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Leonard Davis School of Gerontology, USC, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'Pinchas', 'Initials': 'P', 'LastName': 'Cohen', 'Affiliation': 'Leonard Davis School of Gerontology, USC, Los Angeles, CA, 90033, USA.'}]",Scientific reports,['10.1038/s41598-021-96419-z']
3245,34413362,One-year effects of bifocal and unifocal glasses on executive functions in children with Down syndrome in a randomized controlled trial.,"Appropriate glasses can improve visual functioning of children with Down syndrome (DS), but it is unknown if such interventions influence their cognitive impairments. In a randomized controlled trial with 1-year follow-up. Children with DS (2-16 years) were provided either bifocal glasses (add +2.5 Dioptres; n = 50) or unifocal glasses (n = 52). Executive functions were assessed pre- and post-intervention with the task-based Minnesota Executive Function Scale (MEFS) and with questionnaires, BRIEF-P and BRIEF, parents' and teachers' version. Intervention effects and associations between executive functions, (near) vision and ocular alignment were analysed. Intervention improved MEFS-Total-scores in the bifocal group (p = 0.002; Cohen's d = 0.60) but not in the unifocal group (p = 0.191; Cohen's d = 0.24). Post-intervention, there was no intergroup difference (p = 0.120; Cohen's d = 0.34). Post-intervention, higher MEFS-scores were associated with better visual acuities (crowded near p = 0.025; uncrowded near p = 0.019; distant p = 0.045). Pre-post changes in MEFS-scores correlated significantly with improved ocular alignment (p = 0.040). Exploratory analysis of the questionnaires showed improved teacher-rated BRIEF-scores in both groups (bifocals: p = 0.014, Cohen's d = 1.91; unifocals: p = 0.022, Cohen's d = 1.46), with no intergroup difference (p = 0.594; Cohen's d = 0.23). These results demonstrate positive effects of wearing better-correcting glasses on executive functioning in children with DS, suggesting a link between their visual and executive functioning. However, the relative contributions of distant and near vision need further study.",2021,Intervention improved MEFS-Total-scores in the bifocal group (p = 0.002; Cohen's d = 0.60) but not in the unifocal group (p = 0.191; Cohen's d = 0.24).,"['children with Down syndrome', 'children with Down syndrome (DS', 'Children with DS (2-16\xa0years', 'children with DS']","['bifocal glasses (add +2.5 Dioptres; n\u2009=\u200950) or unifocal glasses', 'bifocal and unifocal glasses']","['MEFS-scores', 'teacher-rated BRIEF-scores', 'Executive functions', ""task-based Minnesota Executive Function Scale (MEFS) and with questionnaires, BRIEF-P and BRIEF, parents' and teachers' version"", 'visual acuities', 'executive functions, (near) vision and ocular alignment', 'executive functioning', 'MEFS-Total-scores', 'visual functioning', 'executive functions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1275647', 'cui_str': 'Bifocal glasses'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0443337', 'cui_str': 'Unifocal'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0729280', 'cui_str': 'Ocular muscle balance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",,0.10999,Intervention improved MEFS-Total-scores in the bifocal group (p = 0.002; Cohen's d = 0.60) but not in the unifocal group (p = 0.191; Cohen's d = 0.24).,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'de Weger', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre Nijmegen, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands. c.deweger@donders.ru.nl.'}, {'ForeName': 'F Nienke', 'Initials': 'FN', 'LastName': 'Boonstra', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre Nijmegen, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Goossens', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre Nijmegen, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-021-96308-5']
3246,34423996,Differential effectiveness of an elementary school social and emotional learning program during middle school transition in Portugal.,"This study analyzed the effectiveness of an elementary school Social and Emotional Learning (SEL) program during middle school transition in Portugal, and the influence of gender, classroom size and student's perception of two school climate dimensions (student-student relationships and teacher-student relationships) upon its effectiveness. One-thousand-sixty-three students (M age = 9.14; SD = 0.64; 51.2% were boys) participated: 702 in the intervention group and 361 in the control group, assessed at pretest, post-test, and follow-up 10 months later (after middle school transition). Multilevel analyses identified that the program was effective in enhancing social awareness, self-control, and self-esteem, even after middle school transition. Results also showed that there no differential gains by gender, and that intervention group students who had more positive perceptions of student-student relationships and teacher-student relationships displayed more positive trajectories in self-esteem. Students from smaller fourth-grade classrooms displayed lower social awareness than students from larger fourth-grade classrooms, but a more positive trajectory in that competence than students from medium and larger fourth-grade classrooms. This study highlights the importance of analyzing the differential effectiveness of SEL programs. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Multilevel analyses identified that the program was effective in enhancing social awareness, self-control, and self-esteem, even after middle school transition.","['middle school transition in Portugal', 'One-thousand-sixty-three students (M age = 9.14; SD = 0.64; 51.2% were boys) participated: 702 in the intervention group and 361 in the control group, assessed at pretest, post-test, and follow-up 10 months later (after middle school transition']","['elementary school Social and Emotional Learning (SEL) program', 'elementary school social and emotional learning program']","['social awareness', 'enhancing social awareness, self-control, and self-esteem', 'positive trajectories in self-esteem']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517470', 'cui_str': '0.64'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0582589', 'cui_str': 'Emotional learning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0207676,"Multilevel analyses identified that the program was effective in enhancing social awareness, self-control, and self-esteem, even after middle school transition.","[{'ForeName': 'Vítor Alexandre', 'Initials': 'VA', 'LastName': 'Coelho', 'Affiliation': 'Académico de Torres Vedras.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Brás', 'Affiliation': 'Académico de Torres Vedras.'}, {'ForeName': 'Anastassios', 'Initials': 'A', 'LastName': 'Matsopoulos', 'Affiliation': 'Department of Preschool Education, University of Crete.'}]","School psychology (Washington, D.C.)",['10.1037/spq0000454']
3247,34423904,"A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance.","N-methyl-D-aspartate ionotropic glutamatergic receptor (NMDAR) modulators, including rapastinel and ketamine, elicit rapid and sustained antidepressant responses in patients with treatment-resistant major depressive disorder. This phase I, randomized, multicenter, placebo-controlled, five-period, crossover, single-dose study evaluated simulated driving performance of healthy participants (N = 107) after single doses of rapastinel slow intravenous (i.v.) bolus 900 and 1800 mg, alprazolam oral 0.75 mg (positive control), ketamine i.v. infusion 0.5 mg/kg (clinical comparator), and placebo ~ 45 min before driving. The primary end point was SD of lateral position (SDLP) during the 60-min 100-km simulated driving scenario. Additional measures of driving performance, sleepiness, and cognition were also evaluated. To assess effects over time, mean SDLP was calculated for each 10-min interval of driving. Sensitivity of the assays was confirmed with alprazolam (all placebo comparisons p < 0.02). Rapastinel 900 and 1800 mg did not significantly affect simulated driving performance compared to placebo (both p > 0.5). Both rapastinel doses resulted in significantly less impaired driving compared to alprazolam or ketamine (all p < 0.002); ketamine significantly impaired driving compared to placebo (p = 0.0001). Results for the additional measures were similar to the primary end point. No new safety signals were observed for any study interventions. This first study of rapastinel effects on simulated driving found that rapastinel 900 and 1800 mg did not impair driving performance, but ketamine 0.5 mg/kg resulted in significantly impaired driving performance. Ketamine's effects on driving were maintained for at least 105 min, indicating that clinicians should be vigilant to prevent or postpone driving in patients after ketamine treatment.",2021,Both rapastinel doses resulted in significantly less impaired driving compared to alprazolam or ketamine (all p<0.002); ketamine significantly impaired driving compared to placebo (p=0.0001).,"['healthy participants (N=107) after single doses of', 'patients with treatment-resistant major depressive disorder']","['Ketamine', 'alprazolam', 'Rapastinel', 'N-methyl-D-aspartate ionotropic glutamatergic receptor (NMDAR) modulators', 'Ketamine, Alprazolam, and Placebo', 'ketamine', 'placebo', 'rapastinel slow intravenous (IV) bolus 900 mg and 1800 mg, alprazolam oral 0.75 mg (positive control), ketamine IV infusion 0.5 mg/kg (clinical comparator), and placebo']","['mean SDLP', 'simulated driving performance', 'driving performance', 'Simulated Driving Performance', 'driving performance, sleepiness, and cognition', 'standard deviation of lateral position (SDLP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C1666271', 'cui_str': 'GLYX-13 peptide'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.131908,Both rapastinel doses resulted in significantly less impaired driving compared to alprazolam or ketamine (all p<0.002); ketamine significantly impaired driving compared to placebo (p=0.0001).,"[{'ForeName': 'Shengfang', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Allergan plc (now AbbVie, Inc.), Madison, New Jersey, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corporation, St. Petersburg, Florida, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hochadel', 'Affiliation': 'Cognitive Research Corporation, St. Petersburg, Florida, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rojo', 'Affiliation': 'Allergan plc (now AbbVie, Inc.), Madison, New Jersey, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Christopher Stein', 'Affiliation': 'Allergan plc (now AbbVie, Inc.), Madison, New Jersey, USA.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Boinpally', 'Affiliation': 'Clinical Pharmacology, AbbVie, Inc., Madison, New Jersey, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Periclou', 'Affiliation': 'Allergan plc (now AbbVie, Inc.), Madison, New Jersey, USA.'}]",Clinical and translational science,['10.1111/cts.13145']
3248,34419999,Sleep and Inhibitory Control Over Mood-Congruent Information in Emerging Adults With Depressive Disorder.,"OBJECTIVE


Accumulating evidence has suggested bidirectionality between sleep problems and depression, but the underlying mechanism is unclear. We assessed the role of sleep in inhibitory control ability with emotional stimuli, which has been shown to be suboptimal among individuals with depression and proposed to perpetuate depressive symptoms.
METHODS


Emerging adults (aged 18-25 years, 64.6% female) were screened for depressive and other mental disorders by structured clinical interview and questionnaire. Individuals with depressive disorders were assigned to have a polysomnography-monitored daytime sleep opportunity (Sleep-Dep, n = 20), whereas nondepressed individuals were randomized to either have daytime sleep (Sleep-Ctrl, n = 27) or stay awake (Wake-Ctrl, n = 18). Participants completed the Affective Go/No-Go Task two times, separated by experimental conditions.
RESULTS


A factorial model with a between-subject factor (Sleep-Dep/Sleep-Ctrl/Wake-Ctrl) and a within-subject factor (test 1/test 2) was used to assess if the groups differed in inhibitory control across test sessions, as inferred by changes in d-prime and false alarm rates (FA). Results from mixed factorial models showed a significant interaction effect between time and group on FA in the block with neutral faces as the target and happy faces as the nontarget (F(2,61) = 5.15, pfdr = .045). Although Sleep-Dep had decreased FA after sleep (t(19) = 2.94, pfdr = .050), Sleep-Ctrl and Wake-Ctrl had no significant between-session changes (p values > .05). Postsleep improvement in FA in Sleep-Dep correlated with longer stage 2 sleep (r(20) = 0.788, pfdr < .001) and stage 2 fast spindle number at O1 (r(18) = 0.692, pfdr = .015).
CONCLUSIONS


Sleep gain, particularly stage 2 sleep and related physiology, potentially enhances inhibitory control ability responding to emotional information among individuals with depressive disorders.",2021,"While Sleep-Dep had decreased FA post-sleep, t(19) = 2.94, pfdr = .050, Sleep-Ctrl and Wake-Ctrl had no significant between-session changes, ps > .05.","['individuals with depressive disorders', 'Adults with Depressive Disorder', 'Individuals with depressive disorders', 'Emerging adults (aged 18-25, 64.6% female) were screened for depressive and other mental disorders by structured clinical interview and questionnaire']","['polysomnography-monitored daytime sleep opportunity (Sleep-Dep, N = 20), while non-depressed individuals were randomized to either have daytime sleep (Sleep-Ctrl, N = 27) or stay awake']",['Sleep-Ctrl and Wake-Ctrl'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0234422', 'cui_str': 'Awake'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}]",,0.0536759,"While Sleep-Dep had decreased FA post-sleep, t(19) = 2.94, pfdr = .050, Sleep-Ctrl and Wake-Ctrl had no significant between-session changes, ps > .05.","[{'ForeName': 'Esther Yuet Ying', 'Initials': 'EYY', 'LastName': 'Lau', 'Affiliation': 'From the Department of Psychology (E. Lau, Lam), Centre for Psychosocial Health (E. Lau, Lam), and Centre for Religious and Spirituality Education (E. Lau), The Education University of Hong Kong, Hong Kong; Department of Psychology (Wong), University of Exeter, Devon, United Kingdom; Clinical Psychological Services (K. Lau), Hong Kong Children & Youth Services; Department of Psychiatry (Chung, E. Lau), Queen Mary Hospital, The University of Hong Kong, Hong Kong; Departments of Psychiatry (Rusak) and Psychology and Neuroscience (Rusak), Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Mark Lawrence', 'Initials': 'ML', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Yeuk Ching', 'Initials': 'YC', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'Kristy Nga Ting', 'Initials': 'KNT', 'LastName': 'Lau', 'Affiliation': ''}, {'ForeName': 'Ka Fai', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rusak', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000996']
3249,34419870,The effect of footbath on the quality of sleep in older adults: A pilot study.,"This pilot study was a randomized controlled trial that aimed to investigate the effect of the warm footbath on the sleep quality of Iranian older adults. Males and females aged over 60 were randomly divided into three groups (footbath group with water at 40°C, footbath group with water at 37°C, and one control group) using the permutation block method. Repeated measures design was used to compare the groups after week two and week four to study the effects of footbath on sleep quality. Footbath with water at 40°C and 37°C caused significant improvement in the participants' sleep quality. No significant difference was found between the participants' sleep quality treated with water at 40°C and 37°C. Future studies with larger samples are recommended for assessing the effectiveness of warm footbath in enhancing sleep quality in older adults.",2021,No significant difference was found between the participants' sleep quality treated with water at 40°C and 37°C.,"['Iranian older adults', 'Males and females aged over 60', 'older adults']","['footbath', 'warm footbath']","['sleep quality', ""participants' sleep quality"", 'quality of sleep']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",60.0,0.0247746,No significant difference was found between the participants' sleep quality treated with water at 40°C and 37°C.,"[{'ForeName': 'Mohamad Reza', 'Initials': 'MR', 'LastName': 'Armat', 'Affiliation': 'Geriatric Care Research Center, Department of Medical-Surgical Nursing, School of Nursing, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mortazavi', 'Affiliation': 'Geriatric Care Research Center, Department of Medical-Surgical Nursing, School of Nursing, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Akbari', 'Affiliation': 'Addiction and Behavioral Sciences Research Center, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Ebrahimzadeh', 'Affiliation': 'Research Committee for Students, School of Nursing, North Khorasan University of Medical Sciences, Bojnurd, Iran. Electronic address: corresponding1981@gmail.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.07.008']
3250,34425421,Effects of nurse-led square dancing on older patients with mild cognitive impairment combined with depressive symptoms: A pilot study.,"OBJECTIVE


The present study aimed to verify the feasibility and preliminary effects of nurse-led square dancing designed to improve older adults' cognitive function and depressive symptoms who with MCI.
METHODS


A quasi-experimental pilot study design was adopted for the present study. Screening for cognitive function was conducted among older adults (≥ 60 years old) living in two communities in Beijing who complained of memory loss. A total of 107 older patients with MCI and depressive symptoms were diagnosed after obtaining informed consent. Thirty-five patients selected from each community were included in the study as control and intervention groups, respectively. The two groups of patients received health education while the intervention group participated in a square dance intervention program led by nurses three times per week for 60 min per session over a period of three months. The Montreal Cognitive Assessment-Peking version (MoCA-P) and Geriatric Depression Scale (GDS-30) were used to assess the cognitive function and depressive symptoms of patients in the two groups at three time intervals; before intervention, at the end of the three-month intervention period, and over a three-month follow-up period after the end of intervention.
RESULTS


Feasibility of the intervention was established with a high completion rate of 90%. Data collection for 63 out of 70 patients enrolled for the study was completed after six months. MoCA-P and GDS-30 scores of the intervention group were significantly different after the intervention when compared with the control group. A significant improvement in cognition was observed in the intervention group, and depressive symptoms decreased after intervention and follow-up when compared with the control group. During the intervention and follow-up phases, the MoCA-P score of the intervention group increased gradually with time. Furthermore, the MoCA-P and GDS-30 scores of the control group remained unchanged.
CONCLUSION


This study has revealed that square dance intervention exerts a positive impact on cognitive function and depressive symptoms among older patients suffering from MCI and depressive symptoms. The results of this study support the feasibility and preliminary effects of square dancing on relieving cognitive decline and depressive symptoms. Square dancing is a recommended type of intervention that can be applied to the local Chinese population because of its simplicity, convenience, and suitability for the older adults.",2021,"During the intervention and follow-up phases, the MoCA-P score of the intervention group increased gradually with time.","['older adults (≥ 60 years old) living in two communities in Beijing who complained of memory loss', 'older patients with mild cognitive impairment combined with depressive symptoms', '107 older patients with MCI and depressive symptoms were diagnosed after obtaining informed consent', 'Thirty-five patients selected from each community were included in the study as control and intervention groups, respectively', '63 out of 70 patients enrolled for the study was completed after six months', ""older adults' cognitive function and depressive symptoms who with MCI"", 'older patients suffering from MCI and depressive symptoms', 'older adults']","['nurse-led square dancing', 'health education while the intervention group participated in a square dance intervention program', 'square dancing']","['relieving cognitive decline and depressive symptoms', 'cognitive function and depressive symptoms', 'depressive symptoms', 'Montreal Cognitive Assessment-Peking version (MoCA-P) and Geriatric Depression Scale (GDS-30', 'cognition', 'MoCA-P and GDS-30 scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4046023', 'cui_str': 'Square Dance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",107.0,0.00629665,"During the intervention and follow-up phases, the MoCA-P score of the intervention group increased gradually with time.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Nursing Department, Peking University First Hospital, Beijing, 100034, PR China. Electronic address: fz0825zy@126.com.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yin', 'Affiliation': 'School of Nursing, Lanzhou University, 28 Yan Xi Rd, Chengguan District. Lanzhou, Gansu province, 730030, PR China. Electronic address: minyin@lzu.edu.cn.'}, {'ForeName': 'Xiuyu', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'School of Nursing, Peking Union Medical College, No 0.33, Badachu Road, Shijingshan District, Beijing, 100144, PR China. Electronic address: yaoxiuyu85@126.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Peking Union Medical College, No 0.33, Badachu Road, Shijingshan District, Beijing, 100144, PR China. Electronic address: zhengli@pumc.edu.cn.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.06.028']
3251,34431744,When the placebo effect is not an effect.,,2021,,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.103375,,"[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Harris', 'Affiliation': 'Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Sydney, Australia.'}]",Acta orthopaedica,['10.1080/17453674.2021.1969155']
3252,34429197,"Effects of Fixed-dose Combination of Low-intensity Rosuvastatin and Ezetimibe Versus Moderate-intensity Rosuvastatin Monotherapy on Lipid Profiles in Patients With Hypercholesterolemia: A Randomized, Double-blind, Multicenter, Phase III Study.","PURPOSE


We investigated whether the combination therapy of low-intensity rosuvastatin and ezetimibe is an useful alternative to moderate-intensity rosuvastatin monotherapy in patients requiring cholesterol-lowering therapy.
METHODS


This was a multicenter randomized, double-blind study to investigate the safety and efficacy of a fixed-dose combination of rosuvastatin 2.5 mg and ezetimibe 10 mg (R2.5+E10) compared to those of ezetimibe 10 mg monotherapy (E10), rosuvastatin 2.5 mg (R2.5), and rosuvastatin 5 mg monotherapy (R5) in patients with hypercholesterolemia. A total of 348 patients at 15 centers in Korea were screened, and 279 patients were randomized to different groups in the study. Clinical and laboratory examinations were performed at baseline and 4 and 8 weeks after intervention. The primary endpoint was the percentage change of low-density lipoprotein (LDL) cholesterol levels at the 8-week follow-up.
FINDINGS


Baseline characteristics were similar among the four groups. There were significant changes in lipid profiles at the 8-week follow-up. A greater decrease in the LDL cholesterol levels (primary endpoint) were found in the R2.5+E10 group (-45.7±18.6%) than in the E10 group (-16.7±14.7%, p<0.0001), R2.5 group (-32.6±15.1%, p<0.0001), and R5 group (-38.9±13.9%, p=0.0003). Similar outcomes were observed regarding the decrease in total cholesterol, non-high-density lipoprotein (HDL) cholesterol, and apolipoprotein B protein. In addition, changes in the triglyceride and HDL levels in the R2.5+E10 group were significantly different compared with those in the E10 group; however, the changes were similar to those in the other treatment groups. In patients with low and moderate risk, all patients achieved the target LDL cholesterol levels in the R2.5+E10 group (100%) compared to 13.0% in the E10 group, 47.6% in the R2.5 group, and 65.2% in the R5 group. Adverse effects were rare and similar in the four groups.
IMPLICATIONS


Fixed-dose combination of low-intensity rosuvastatin and ezetimibe was more effective in lowering LDL cholesterol and achieving LDL cholesterol goals than moderate-intensity rosuvastatin monotherapy. These findings suggest that the combination therapy of low-intensity rosuvastatin and ezetimibe is an useful alternative to moderate-intensity rosuvastatin monotherapy for cholesterol management, particularly in patients with low and moderate risk. ClinicalTrials.gov identifier: NCT04652349.",2021,"A greater decrease in the LDL cholesterol levels (primary endpoint) were found in the R2.5+E10 group (-45.7±18.6%) than in the E10 group (-16.7±14.7%, p<0.0001), R2.5 group (-32.6±15.1%, p<0.0001), and R5 group (-38.9±13.9%, p=0.0003).","['Patients', '348 patients at 15 centers in Korea were screened, and 279 patients', 'patients with hypercholesterolemia', 'patients requiring cholesterol-lowering therapy', 'patients with low and moderate risk']","['Hypercholesterolemia', 'ezetimibe 10 mg monotherapy (E10), rosuvastatin 2.5 mg (R2.5), and rosuvastatin 5 mg monotherapy (R5', 'low-intensity rosuvastatin and ezetimibe', 'Fixed-Dose Combination of Low-Intensity Rosuvastatin and Ezetimibe', 'ezetimibe', 'rosuvastatin 2.5 mg and ezetimibe 10 mg (R2.5+E10']","['target LDL cholesterol levels', 'safety and efficacy', 'lipid profiles', 'percentage change of low-density lipoprotein (LDL) cholesterol levels', 'total cholesterol, non-high-density lipoprotein (HDL) cholesterol, and apolipoprotein B protein', 'Lipid Profiles', 'Adverse effects', 'lowering LDL cholesterol and achieving LDL cholesterol goals', 'triglyceride and HDL levels', 'LDL cholesterol levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C1166438', 'cui_str': 'ezetimibe 10 MG'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C5136929', 'cui_str': 'rosuvastatin 5 MG [Ezallor]'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C3700394', 'cui_str': 'rosuvastatin and ezetimibe'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C1535899', 'cui_str': 'Non-high-density lipoprotein cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",348.0,0.0327011,"A greater decrease in the LDL cholesterol levels (primary endpoint) were found in the R2.5+E10 group (-45.7±18.6%) than in the E10 group (-16.7±14.7%, p<0.0001), R2.5 group (-32.6±15.1%, p<0.0001), and R5 group (-38.9±13.9%, p=0.0003).","[{'ForeName': 'Seung-Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Weon', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiovascular Medicine, Kyung Hee University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Taek Jong', 'Initials': 'TJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Cardiovascular Center, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Moo Hyun', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Dong-A University Medical Center, Busan, Republic of Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Bong Sik', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hyundae General Hospital, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Seok Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiovascular Center, Seoul Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Chae', 'Affiliation': 'Cardiovascular Center, Seoul National University Bundang Hospital, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Byung Jin', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Moo-Yong', 'Initials': 'MY', 'LastName': 'Rhee', 'Affiliation': 'Cardiovascular Center, Dongguk University Ilsan Hospital, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Joon Han', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Division of Cardiology, Ajou University Medical Center, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Tae Soo', 'Initials': 'TS', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Dankook University Hospital, Dankook University School of Medicine, Chungcheongnam-do, Republic of Korea.'}, {'ForeName': 'Jin Man', 'Initials': 'JM', 'LastName': 'Cho', 'Affiliation': 'Cardiovascular Center, Kyunghee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Cheol Whan', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: cheolwlee@amc.seoul.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2021.07.016']
3253,34428440,Text messages for primary prevention of cardiovascular disease: The TextMe2 randomized clinical trial.,"BACKGROUND


Primary prevention guidelines emphasize the importance of lifestyle modification, but many at high-risk have suboptimal cardiovascular risk factor (CVRF) control. Text message support may improve control, but the evidence is sparse. Our objective was to determine the impact of text messages on multiple CVRFs in a moderate-high risk primary prevention cohort.
METHODS


This study was a single-blind randomized clinical trial comparing semi-personalized text message-based support to standard care. A random sample of adults with 10-year absolute cardiovascular risk score ≥10% and without coronary heart disease, referred from February 2019 to January 2020, were recruited from an outpatient cardiology clinic in a large tertiary hospital in Sydney, Australia. Patients were randomized 1:1 to intervention or control. Intervention participants received 4 texts per week over 6 months, and standard care, with content covering: diet, physical activity, smoking, general cardiovascular health, and medication adherence. Controls received standard care only. Content was semipersonalized (smoking status, vegetarian or not-vegetarian, physical ability, taking medications or not) and delivered randomly using automated software. The primary outcome was the difference in the proportion of patients who have ≥3 uncontrolled CVRFs (out of: low-density lipoprotein cholesterol >2.0 mmol/L, blood pressure >140/90 mm Hg, body mass index ≥25 kg/m 2 , physical inactivity, current smoker) at 6 months adjusted for baseline. Secondary outcomes included differences in biomedical and behavioral CVRFs.
RESULTS


Among 295 eligible participants, 246 (mean age, 58.6 ± 10.7 years; 39.4% female) were randomized to intervention (n = 124) or control (n = 122). At 6 months, there was no significant difference in the proportion of patients with ≥3 uncontrolled CVRFs (adjusted relative risk [RR] 0.98; 95% confidence interval [CI] 0.75-1.29; P = .88). Intervention participants were less likely to be physically inactive (adjusted RR 0.72; 95% CI 0.57-0.92; P = .01), but there were no significant changes in other single CVRFs. More intervention participants reduced the number of uncontrolled CVRFs at 6-months from baseline than controls (86% vs 75%; RR 1.15; 95% CI 1.00-1.32; P = .04).
CONCLUSIONS


In moderate-high cardiovascular risk primary prevention, text message-based support did not significantly reduce the proportion of patients with ≥3 uncontrolled CVRFs. However, the program did motivate behavior change and significantly improved cardiovascular risk factor control overall. Larger multicenter studies are needed.",2021,"Intervention participants were less likely to be physically inactive (adjusted RR 0.72; 95%CI 0.57-0.92; P=0.01), but there were no significant changes in other single CVRFs.","['primary prevention of cardiovascular disease', '295 eligible participants, 246 (mean age, 58.6±10.7 years; 39.4% female', 'adults with 10-year absolute cardiovascular risk score ≥10% and without coronary heart disease, referred from February 2019 to January 2020, were recruited from an outpatient cardiology clinic in a large tertiary hospital in Sydney, Australia']",['semi-personalised text message-based support to standard care'],"['number of uncontrolled CVRFs', 'proportion of patients who have ≥3 uncontrolled CVRFs (out of: low-density lipoprotein cholesterol >2.0 mmol/L, blood pressure', 'proportion of patients with ≥3 uncontrolled CVRFs', 'cardiovascular risk factor control overall', 'biomedical and behavioural CVRFs']","[{'cui': 'C2585889', 'cui_str': 'Primary prevention of cardiovascular disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3810847', 'cui_str': 'Cardiology clinic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",295.0,0.312957,"Intervention participants were less likely to be physically inactive (adjusted RR 0.72; 95%CI 0.57-0.92; P=0.01), but there were no significant changes in other single CVRFs.","[{'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Klimis', 'Affiliation': 'Westmead Applied Research Centre and Faculty of Medicine and Health, University of Sydney, Westmead, NSW, Australia; Department of Cardiology, Westmead Hospital, Sydney, NSW, Australia. Electronic address: harry.klimis@sydney.edu.au.'}, {'ForeName': 'Aravinda', 'Initials': 'A', 'LastName': 'Thiagalingam', 'Affiliation': 'Westmead Applied Research Centre and Faculty of Medicine and Health, University of Sydney, Westmead, NSW, Australia; Department of Cardiology, Westmead Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'McIntyre', 'Affiliation': 'Westmead Applied Research Centre and Faculty of Medicine and Health, University of Sydney, Westmead, NSW, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Marschner', 'Affiliation': 'Westmead Applied Research Centre and Faculty of Medicine and Health, University of Sydney, Westmead, NSW, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Von Huben', 'Affiliation': 'Westmead Applied Research Centre and Faculty of Medicine and Health, University of Sydney, Westmead, NSW, Australia.'}, {'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Westmead Applied Research Centre and Faculty of Medicine and Health, University of Sydney, Westmead, NSW, Australia; Department of Cardiology, Westmead Hospital, Sydney, NSW, Australia.'}]",American heart journal,['10.1016/j.ahj.2021.08.009']
3254,34406350,Association of Atrial Fibrillation Burden With Health-Related Quality of Life After Atrial Fibrillation Ablation: Substudy of the Cryoballoon vs Contact-Force Atrial Fibrillation Ablation (CIRCA-DOSE) Randomized Clinical Trial.,"Importance


Patients with atrial fibrillation (AF) have impaired health-related quality of life primarily owing to symptoms related to AF episodes; however, quality of life can be influenced by AF therapies, AF complications, the frequency of follow-up visits and hospitalizations, illness perceptions, and patient factors, such as anxiety or depression.
Objective


To determine the association between change in AF burden and quality of life in the year following ablation.
Design, Setting, and Participants


The current study is a secondary analysis of a prospective, parallel-group, multicenter, single-masked randomized clinical trial (Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration [CIRCA-DOSE] study), which took place at 8 Canadian centers. Between September 2014 and July 2017, 346 patients older than 18 years with symptomatic, primarily low-burden AF refractory to antiarrhythmic therapy referred for first catheter ablation were enrolled. All patients received an implantable cardiac monitor at least 30 days before ablation and were followed up with up to December 2018. Data were analyzed from April 2020 to June 2021.
Interventions


Patients were randomized 1:1:1 to contact force-guided radiofrequency ablation, 4-minute cryoballoon ablation, or 2-minute cryoballoon ablation. The exposure in the present analysis is the absolute difference in AF burden prior to ablation and 12 months following ablation, as evaluated by the Atrial Fibrillation Effect on Quality of Life (AFEQT) Score.
Main Outcomes and Measures


Absolute difference in quality of life from baseline to 12 months postablation.
Results


Of 346 included patients, 231 (66.7%) were male, and the median (interquartile range) age was 60 (52-66) years. A total of 328 patients (94.8%) had paroxysmal AF. The median (interquartile range) preablation AF burden was 2.0% (0.1-11.9), and the AF burden decreased to 0% at 12 months postablation. At 12 months, a 1-point improvement in AFEQT score was observed for every absolute reduction in daily AF burden of 15.8 minutes (95% CI, 7.2-24.4; P < .001), or every 0.63% (95% CI, 0.30-0.95; P < .001) reduction in relative AF burden from baseline.
Conclusions and Relevance


In patients with primarily low-burden paroxysmal AF, the reduction in AF burden following ablation may be associated with a clinically meaningful improvement in quality of life.
Trial Registration


ClinicalTrials.gov Identifier: NCT01913522.",2021,"At 12 months, a 1-point improvement in AFEQT score was observed for every absolute reduction in daily AF burden of 15.8 minutes (95% CI, 7.2-24.4; P < .001), or every 0.63% (95% CI, 0.30-0.95; P < .001) reduction in relative AF burden from baseline.
","['328 patients (94.8%) had paroxysmal AF', 'Between September 2014 and July 2017, 346 patients older than 18 years with symptomatic, primarily low-burden AF refractory to antiarrhythmic therapy referred for first catheter ablation were enrolled', 'Importance\n\n\nPatients with atrial fibrillation (AF', 'Results\n\n\nOf 346 included patients, 231 (66.7%) were male, and the median (interquartile range) age was 60 (52-66) years']","['contact force-guided radiofrequency ablation, 4-minute cryoballoon ablation, or 2-minute cryoballoon ablation', 'Cryoballoon vs Irrigated Radiofrequency Catheter Ablation', 'Cryoballoon vs Contact-Force Atrial Fibrillation Ablation (CIRCA-DOSE', 'implantable cardiac monitor', 'Double Short vs Standard Exposure Duration [CIRCA-DOSE']","['Quality of Life (AFEQT) Score', 'Atrial Fibrillation Burden', 'relative AF burden', 'AFEQT score', 'AF burden and quality of life', 'median (interquartile range) preablation AF burden', 'Quality of Life', 'AF burden', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3879681', 'cui_str': 'Implantable cardiac monitor'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",328.0,0.172467,"At 12 months, a 1-point improvement in AFEQT score was observed for every absolute reduction in daily AF burden of 15.8 minutes (95% CI, 7.2-24.4; P < .001), or every 0.63% (95% CI, 0.30-0.95; P < .001) reduction in relative AF burden from baseline.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Samuel', 'Affiliation': 'Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': 'Department of Medicine, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Leong-Sit', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Department of Medicine, Royal Jubilee Hospital, Victoria, British Columbia, Canada.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Badra-Verdu', 'Affiliation': 'Department of Medicine, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}]",JAMA cardiology,['10.1001/jamacardio.2021.3063']
3255,34406349,Efficacy and Safety of Adalimumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: The SHARPS Randomized Clinical Trial.,"Importance


Surgery is a mainstay in the management of hidradenitis suppurativa (HS). Adalimumab is the first drug approved for HS.
Objective


To investigate the efficacy and safety of adalimumab in combination with wide-excision surgery followed by secondary intention healing.
Design, Setting, and Participants


The Safety and Efficacy of Adalimumab for Hidradenitis Suppurativa Peri-Surgically (SHARPS) trial was a phase 4, randomized, double-blind, placebo-controlled study of adalimumab in conjunction with surgery. Patients were enrolled in 45 sites across 20 countries from July 18, 2016, to February 2, 2019, with the last patient visit on October 16, 2019. Eligible patients (aged 18-65 years) had moderate to severe HS that required radical surgery in an axillary or inguinal region and had 2 other anatomical regions affected, with 1 or more regions at Hurley stage II or III. Analysis was conducted in November 2019.
Interventions


Patients were randomized 1:1 to receive continuous adalimumab, 40 mg, or placebo during presurgery (12 weeks), perioperative (2 weeks), and postoperative (10 weeks) periods.
Main Outcomes and Measures


The primary end point was the proportion of patients achieving HS clinical response across all body regions at week 12.
Results


Overall, 103 patients were randomized to adalimumab and 103 to matching placebo. Among all patients, 51% (n = 106) were women, 94% (n = 193) were White, and the mean (SD) age was 37.6 (11.3) years. At week 12, significantly more patients receiving adalimumab (49 of 103 [48%]) vs placebo (35 of 103 [34%]; P = .049) achieved HS clinical response across all body regions (treatment difference, 14% [95% CI, 0%-27%]). Treatment-emergent adverse events were reported in 74 of 103 patients (72%) and 69 of 103 patients (67%) in the adalimumab and placebo groups, respectively. No increased risk of postoperative wound infection, complication, or hemorrhage was observed with adalimumab vs placebo. Two deaths occurred in the adalimumab group; neither was considered as having a reasonable possibility of relationship to study drug.
Conclusions and Relevance


Adalimumab was efficacious in conjunction with wide-excision surgery followed by secondary intention healing, with no need to interrupt treatment prior to surgery. These data support further investigation of adalimumab as an adjuvant therapy to surgery in patients with moderate to severe HS.
Trial Registration


ClinicalTrials.gov Identifier: NCT02808975.",2021,"No increased risk of postoperative wound infection, complication, or hemorrhage was observed with adalimumab vs placebo.","['Patients were enrolled in 45 sites across 20 countries from July 18, 2016, to February 2, 2019, with the last patient visit on October 16, 2019', 'Eligible patients (aged 18-65 years) had moderate to severe HS that required radical surgery in an axillary or inguinal region and had 2 other anatomical regions affected, with 1 or more regions at Hurley stage II or III', 'Moderate to Severe Hidradenitis Suppurativa', 'Among all patients, 51% (n\u2009=\u2009106) were women, 94% (n\u2009=\u2009193) were White, and the mean (SD) age was 37.6 (11.3) years', '103 patients', 'patients with moderate to severe HS']","['adalimumab vs placebo', 'adalimumab', 'HS', 'continuous adalimumab, 40 mg, or placebo', 'placebo', 'Adalimumab']","['HS clinical response', 'proportion of patients achieving HS clinical response', 'risk of postoperative wound infection, complication, or hemorrhage', 'efficacy and safety', 'Efficacy and Safety', 'Treatment-emergent adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",103.0,0.693452,"No increased risk of postoperative wound infection, complication, or hemorrhage was observed with adalimumab vs placebo.","[{'ForeName': 'Falk G', 'Initials': 'FG', 'LastName': 'Bechara', 'Affiliation': 'Department of Dermatology, Venereology, and Allergology, St Josef Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Podda', 'Affiliation': 'Department of Dermatology, Medical Center Klinikum Darmstadt, Teaching Hospital Goethe-University Frankfurt, Darmstadt, Germany.'}, {'ForeName': 'Errol P', 'Initials': 'EP', 'LastName': 'Prens', 'Affiliation': 'Department of Dermatology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Horváth', 'Affiliation': 'Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Evangelos J', 'Initials': 'EJ', 'LastName': 'Giamarellos-Bourboulis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens Medical School, Athens, Greece.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': ""Division of Dermatology, Women's College Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Jacek C', 'Initials': 'JC', 'LastName': 'Szepietowski', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Joslyn', 'Initials': 'J', 'LastName': 'Kirby', 'Affiliation': 'Department of Dermatology, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Ziqian', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Jean', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Gregor B E', 'Initials': 'GBE', 'LastName': 'Jemec', 'Affiliation': 'Department of Dermatology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Christos C', 'Initials': 'CC', 'LastName': 'Zouboulis', 'Affiliation': 'Department of Dermatology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany.'}]",JAMA surgery,['10.1001/jamasurg.2021.3655']
3256,34415257,"Protective Dressings, Injury, and Device Failure in Preterm Infants Receiving Nasal Continuous Positive Airway Pressure: A Randomized Controlled Trial.","OBJECTIVE


To investigate the protective effect of a hydrocolloid nasal dressing on the incidence and severity of nasal injury and continuous positive airway pressure (CPAP) failure in preterm infants receiving nasal CPAP (N-CPAP).
METHODS


A randomized controlled trial was conducted over 4 months in 2019 at level 3 neonatal ICUs in two hospitals affiliated with Isfahan University of Medical Sciences, Iran. Eighty eligible infants were born at 32 weeks of gestation or younger and/or with a birth weight of 1,500 g or less and had received between 4 and 72 hours of CPAP. Infants were randomly assigned to two groups; the intervention group used a protective dressing, and the control group received routine care. Data collection tools included a demographic questionnaire and nasal injury assessment score chart.
MAIN OUTCOME MEASURES


The incidence and severity of nasal injury in preterm infants undergoing N-CPAP.
RESULTS


Infants in the intervention group had a significantly lower incidence and severity of nasal injury compared with the control group: 15 of 40 (37.5%) versus 37 of 40 (92.5%; P < .001). Overall, the injuries identified in this study were mostly mild and moderate, with only three severe injuries in the intervention group and five in the control group. No significant differences were detected in CPAP failure (P > .05).
CONCLUSIONS


The studied nasal barrier dressing is a safe and convenient solution to reduce nasal injury in preterm infants receiving N-CPAP.",2021,The studied nasal barrier dressing is a safe and convenient solution to reduce nasal injury in preterm infants receiving N-CPAP.,"['preterm infants undergoing N-CPAP', '4 months in 2019 at level 3 neonatal ICUs in two hospitals affiliated with Isfahan University of Medical Sciences, Iran', 'preterm infants receiving nasal CPAP (N-CPAP', 'preterm infants receiving N-CPAP', 'Eighty eligible infants were born at 32 weeks of gestation or younger and/or with a birth weight of 1,500 g or less and had received between 4 and 72 hours of CPAP', 'Preterm Infants']","['Nasal Continuous Positive Airway Pressure', 'hydrocolloid nasal dressing', 'protective dressing, and the control group received routine care']","['demographic questionnaire and nasal injury assessment score chart', 'incidence and severity of nasal injury', 'incidence and severity of nasal injury and continuous positive airway pressure (CPAP) failure', 'CPAP failure']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C1292423', 'cui_str': '72 hours'}]","[{'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0020266', 'cui_str': 'Hydrocolloid'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0272427', 'cui_str': 'Injury of nose'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",80.0,0.0660967,The studied nasal barrier dressing is a safe and convenient solution to reduce nasal injury in preterm infants receiving N-CPAP.,"[{'ForeName': 'Parvane', 'Initials': 'P', 'LastName': 'Rezaei', 'Affiliation': ""At the Isfahan University of Medical Sciences, Iran, Parvane Rezaei, MS, is a nursing student, Faculty of Nursing and Midwifery; Soheila Jafari-Mianaeib, PhD, is Assistant Professor, Department of Pediatric and Neonatal Nursing; Alireza Sadeghnia, MD, is Associate Professor, Department of Pediatrics; and Zahra Heidari, PhD, is Assistant Professor, Department of Biostatistics and Epidemiology. Acknowledgments: The authors thank the Isfahan University of Medical Sciences, the staff of the neonatal ICU wards of Shahid Beheshti and Al-Zahra Hospitals of Isfahan, and the tiny infants who participated in this study. This study originated from a master's thesis supported financially with a grant from the Isfahan University of Medical Sciences. The authors have disclosed no other financial relationships related to this article. Submitted September 22, 2020; accepted in revised form November 5, 2020.""}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Jafari-Mianaeib', 'Affiliation': ''}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sadeghnia', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidari', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000767344.37591.b6']
3257,34416962,Salmonella Typhimurium DT 104 response to Lytic bacteriophage and Lactobionic acid on raw chicken breast.,"Bacterial food poisoning cases due to Salmonella have been linked with a variety of poultry products. This study evaluated the effects of a Salmonella-specific Lytic bacteriophage and Lactobionic acid (LBA) on Salmonella Typhimurium DT 104 growth on raw chicken breast meat. Each chicken breast was randomly assigned to a treatment group (Control, DI water, phage 1%, phage 5%, LBA 10 mg/mL, LBA 20 mg/mL, and phage 5% + LBA 20 mg/mL) with four chicken breasts per group. Samples were inoculated with 10 6  CFU/mL of Salmonella and stored at 4 °C for 30 min. The inoculated chicken breasts were randomly assigned to different storage time (0 h, 1 h, 24 h, or 48 h). Both time and treatment showed significance reduction (P < 0.0001) of microbial growth. The weight loss was significantly different (P < 0.0001) between treatments. The LBA treatments were not effective when compared to the control group, but Lytic bacteriophage significantly reduced the amount of microbial growth.",2021,"The LBA treatments were not effective when compared to the control group, but Lytic bacteriophage significantly reduced the amount of microbial growth.","['inoculated chicken breasts', 'Salmonella Typhimurium', 'raw chicken breast']","['LBA', 'LBA 10\xa0mg/mL, LBA 20\xa0mg/mL, and phage 5%\xa0', 'Lytic bacteriophage and Lactobionic acid', 'Salmonella-specific Lytic bacteriophage and Lactobionic acid (LBA']",['weight loss'],"[{'cui': 'C0158731', 'cui_str': 'Congenital pectus carinatum'}, {'cui': 'C0036126', 'cui_str': 'Salmonella Typhimurium'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}]","[{'cui': 'C0064598', 'cui_str': 'lactobionic acid'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0004651', 'cui_str': 'Bacterial virus'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0036111', 'cui_str': 'Salmonella'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0357983,"The LBA treatments were not effective when compared to the control group, but Lytic bacteriophage significantly reduced the amount of microbial growth.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Walker', 'Affiliation': 'Biological Sciences Department, California Polytechnic State University, San Luis Obispo, 93407, USA.'}, {'ForeName': 'Sherita', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Animal Science Department, California Polytechnic State University, San Luis Obispo, 93407, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Strauss', 'Affiliation': 'Food Science & Nutrition Department, California Polytechnic State University, San Luis Obispo, 93407, USA.'}, {'ForeName': 'Siroj', 'Initials': 'S', 'LastName': 'Pokharel', 'Affiliation': 'Animal Science Department, California Polytechnic State University, San Luis Obispo, 93407, USA. Electronic address: spokhare@calpoly.edu.'}]",Food microbiology,['10.1016/j.fm.2021.103862']
3258,34418549,"Treatment of androgenetic alopecia with 5-aminolevulinic acid photodynamic therapy: A randomized, placebo-controlled, split-scalp study of efficacy and safety.","BACKGROUND AND OBJECTIVES


Androgenetic alopecia (AGA) is one of the most common hair loss disorders. Treatment options for AGA are limited . New therapies for AGA are clinically needed. 5-aminolevulinic acid photodynamic therapy (ALA-PDT) is widely applied in diseases involving the pilosebaceous unit. However, limited research has explored the efficacy of ALA-PDT in treating alopecia. Some studies reported hair regrowth after PDT in alopecia areata patients, but the efficacy of ALA-PDT on AGA remains unclear. The objective of this study is to evaluate the efficacy and safety of ALA-PDT for the treatment of AGA.
METHODS


A randomized, placebo-controlled, split-scalp clinical study was conducted. Subjects with AGA received six sessions of 5% ALA-PDT on one half of their scalp and the red-light therapy on the other half. The treatments were applied every two weeks for six sessions on each subject.
RESULTS


There were 7 subjects enrolled in this study. No significant difference in hair density was observed between the red-light treatment and ALA-PDT treatment. The hair density in the ALA-PDT treated half of the scalp significantly decreased 1 week after the treatment, then it increased, and no statistical difference was found at 12 weeks after the last treatment compared to the baseline. There was no significant improvement in hair growth according to a 7-point scale and the subjects' self-assessments. The main adverse effects in ALA-PDT treatment were mild edema and tolerable pain, and no adverse effect was observed in red-light treatment.
CONCLUSIONS


6 sessions of 5% ALA-PDT did not increase the hair growth of AGA patients, but slightly suppressed the sebum secretion on the scalp. The adverse effects of ALA-PDT were mild, which indicated safety and tolerability of this treatment.",2021,"The hair density in the ALA-PDT treated half of the scalp significantly decreased 1 week after the treatment, then it increased, and no statistical difference was found at 12 weeks after the last treatment compared to the baseline.",['alopecia areata patients'],"['acid photodynamic therapy (ALA-PDT', '5-aminolevulinic', '5-aminolevulinic acid photodynamic therapy', 'ALA-PDT', 'placebo']","['hair growth', 'adverse effect', 'hair density', 'mild edema and tolerable pain', 'sebum secretion', 'safety and tolerability']","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0232407', 'cui_str': 'Hair growth'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0232436', 'cui_str': 'Sebaceous gland activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",7.0,0.0677204,"The hair density in the ALA-PDT treated half of the scalp significantly decreased 1 week after the treatment, then it increased, and no statistical difference was found at 12 weeks after the last treatment compared to the baseline.","[{'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, School of Medicine, Tongji University, Shanghai, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, School of Medicine, Tongji University, Shanghai, China.'}, {'ForeName': 'Linglin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, School of Medicine, Tongji University, Shanghai, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, School of Medicine, Tongji University, Shanghai, China. Electronic address: yunfeng0519116@aliyun.com.'}, {'ForeName': 'Zhongxia', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, School of Medicine, Tongji University, Shanghai, China.'}, {'ForeName': 'Guolong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, School of Medicine, Tongji University, Shanghai, China.'}, {'ForeName': 'Peiru', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, School of Medicine, Tongji University, Shanghai, China. Electronic address: wpeiru@qq.com.'}, {'ForeName': 'Weiyi', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Skin and Cosmetic Research Department, Shanghai Skin Disease Hospital, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, School of Medicine, Tongji University, Shanghai, China. Electronic address: wangxiuli_1400023@tongji.edu.cn.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102491']
3259,34418262,Aiming for the Bullseye: Targeted activities decrease misconceptions related to enzyme function for undergraduate biochemistry students.,"Biochemistry curricula present a particular challenge to undergraduate students with abstract concepts which can lead to misconceptions that impede learning. In particular, these students have difficulty understanding enzyme structure and function concepts. Targeted learning activities and three-dimensional (3D) physical models are proposed to help students challenge these misconceptions and increase conceptual understanding. Here we assessed such pedagogical tools using the Enzyme-Substrate Interactions Concept Inventory (ESICI) to measure (mis)conceptual changes from Pre- to Post- time points in a single semester undergraduate biochemistry course. A Control group of students engaged with the active learning activities without the 3D physical models and students in the Intervention group utilized these activities with the 3D physical models. At the Post- time point both groups had higher, yet similar ESICI scores of the same magnitude as the highest scoring group from the national sample. Concomitantly, many misconception markers decreased compared to the national sample, although some of these differed between the Control and Intervention groups. Based on this assessment, both pedagogical approaches successfully increased conceptual understanding and targeted many of the misconceptions measured by the ESICI, however, several misconceptions persisted. Surprisingly, the students who used the 3D physical models did not demonstrate a further decrease in the misconception markers. Additionally, psychometric evaluation of the ESICI with our sample recommends the revision of several questions to improve the validity of this assessment. We also offer suggestions to improve instruction and pedagogical tools with further avenues for research on learning.",2021,"Surprisingly, the students who used the 3D physical models did not demonstrate a further decrease in the misconception markers.",['undergraduate biochemistry students'],[],"['misconception markers', 'ESICI scores']","[{'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0173872,"Surprisingly, the students who used the 3D physical models did not demonstrate a further decrease in the misconception markers.","[{'ForeName': 'Cassidy R', 'Initials': 'CR', 'LastName': 'Terrell', 'Affiliation': 'Center for Learning Innovation, University of Minnesota, Rochester, Minnesota, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ekstrom', 'Affiliation': 'Center for Learning Innovation, University of Minnesota, Rochester, Minnesota, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Nguyen', 'Affiliation': 'Center for Learning Innovation, University of Minnesota, Rochester, Minnesota, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Nickodem', 'Affiliation': 'School of Education, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Biochemistry and molecular biology education : a bimonthly publication of the International Union of Biochemistry and Molecular Biology,['10.1002/bmb.21575']
3260,34424530,Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS).,"BACKGROUND


Acute myeloid leukemia (AML) is fatal in elderly patients who are unfit for standard induction chemotherapy. The objective of this study was to evaluate the survival benefit of administering sapacitabine, an oral nucleoside analogue, in alternating cycles with decitabine, a low-intensity therapy, to elderly patients with newly diagnosed AML.
METHODS


This randomized, open-label, phase 3 study (SEAMLESS) was conducted at 87 sites in 11 countries. Patients aged ≥70 years who were not candidates for or chose not to receive standard induction chemotherapy were randomized 1:1 to arm A (decitabine in alternating cycles with sapacitabine) received 1-hour intravenous infusions of decitabine 20 mg/m 2  once daily for 5 consecutive days every 8 weeks (first cycle and subsequent odd cycles) and sapacitabine 300 mg twice daily on 3 consecutive days per week for 2 weeks every 8 weeks (second cycle and subsequent even cycles) or to control arm C who received 1-hour infusions of decitabine 20 mg/m 2  once daily for 5 consecutive days every 4 weeks. Prior hypomethylating agent therapy for preexisting myelodysplastic syndromes or myeloproliferative neoplasms was an exclusion criterion. Randomization was stratified by antecedent myelodysplastic syndromes or myeloproliferative neoplasms, white blood cell count (<10 × 10 9  /L and ≥10 × 10 9  /L), and bone marrow blast percentage (≥50% vs <50%). The primary end point was overall survival (OS). Secondary end points were the rates of complete remission (CR), CR with incomplete platelet count recovery, partial remission, hematologic improvement, and stable disease along with the corresponding durations, transfusion requirements, number of hospitalized days, and 1-year survival. The trial is registered at ClinicalTrials.gov (NCT01303796).
RESULTS


Between October 2011 and December 2014, 482 patients were enrolled and randomized to receive decitabine administered in alternating cycles with sapacitabine (study arm, n = 241) or decitabine monotherapy (control arm, n = 241). The median OS was 5.9 months on the study arm versus 5.7 months on the control arm (P = .8902). The CR rate was 16.6% on the study arm and 10.8% on the control arm (P = .1468). In patients with white blood cell counts <10 × 10 9  /L (n = 321), the median OS was higher on the study arm versus the control arm (8.0 vs 5.8 months; P = .145), as was the CR rate (21.5% vs 8.6%; P = .0017).
CONCLUSIONS


The regimen of decitabine administered in alternating cycles with sapacitabine was active but did not significantly improve OS compared with decitabine monotherapy. Subgroup analyses suggest that patients with baseline white blood cell counts <10 × 10 9  /L might benefit from decitabine alternating with sapacitabine, with an improved CR rate and the convenience of an oral drug. These findings should be prospectively confirmed.",2021,The median OS was 5.9 months on the study arm versus 5.7 months on the control arm (P = .8902).,"['Between October 2011 and December 2014', '482 patients', '3 study (SEAMLESS) was conducted at 87 sites in 11 countries', 'elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS', 'elderly patients with newly diagnosed AML', 'elderly patients who are unfit for standard induction chemotherapy', 'Patients aged ≥70 years who were not candidates for or chose not to receive standard induction chemotherapy']","['decitabine, a low-intensity therapy', 'decitabine monotherapy', 'oral sapacitabine', 'sapacitabine', 'decitabine', 'decitabine in alternating cycles with sapacitabine']","['myelodysplastic syndromes or myeloproliferative neoplasms, white blood cell count', 'OS', 'CR rate', 'overall survival (OS', 'survival benefit', 'median OS', 'bone marrow blast percentage', 'rates of complete remission (CR), CR with incomplete platelet count recovery, partial remission, hematologic improvement, and stable disease along with the corresponding durations, transfusion requirements, number of hospitalized days, and 1-year survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0764827', 'cui_str': 'sapacitabine'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}]","[{'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}, {'cui': 'C0027022', 'cui_str': 'Myeloproliferative disorder'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}]",482.0,0.203778,The median OS was 5.9 months on the study arm versus 5.7 months on the control arm (P = .8902).,"[{'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kebede H', 'Initials': 'KH', 'LastName': 'Begna', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Altman', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Stuart L', 'Initials': 'SL', 'LastName': 'Goldberg', 'Affiliation': 'Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Mikkael A', 'Initials': 'MA', 'LastName': 'Sekeres', 'Affiliation': 'Hematologic Oncology and Blood Disorders, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Strickland', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.'}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Arellano', 'Affiliation': 'Hematology/Oncology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Claxton', 'Affiliation': 'Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Baer', 'Affiliation': 'University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Gautier', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Ellin', 'Initials': 'E', 'LastName': 'Berman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Seiter', 'Affiliation': 'Department of Medicine, New York Medical College, Valhalla, New York.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Solomon', 'Affiliation': 'Northside Hospital Cancer Institute, Leukemia Program, Atlanta, Georgia.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Schiller', 'Affiliation': 'Hematological Malignancy/Stem Cell Transplant Program, David Geffen School of Medicine at the University of California, Los Angeles, California.'}, {'ForeName': 'Selina M', 'Initials': 'SM', 'LastName': 'Luger', 'Affiliation': 'Department of Hematology/Oncology, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Butrym', 'Affiliation': 'Department of Hematology, Blood Neoplasms, and Bone Marrow Transplantation, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gaidano', 'Affiliation': 'Division of Hematology, Maggiore della Carita University Hospital, Novara, Italy.'}, {'ForeName': 'Xavier G', 'Initials': 'XG', 'LastName': 'Thomas', 'Affiliation': 'Hematology, South Hospital Center, Lyon, France.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'La Fe University and Polytechnic Hospital, Valencia, Spain.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Rizzieri', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Quick', 'Affiliation': 'Joe Arrington Cancer Center, Lubbock, Texas.'}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Venugopal', 'Affiliation': 'Department of Medicine, Hematology, and Oncology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Gaur', 'Affiliation': ""St Luke's Cancer Institute, Kansas City, Missouri.""}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Maness', 'Affiliation': 'Division of Hematology-Oncology Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Tapan M', 'Initials': 'TM', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Buyse', 'Affiliation': 'International Drug Development Institute, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Judy H', 'Initials': 'JH', 'LastName': 'Chiao', 'Affiliation': 'Cyclacel Limited, Dundee, United Kingdom.'}]",Cancer,['10.1002/cncr.33828']
3261,34420685,Intravenous lidocaine attenuates response to cervical dilation for hysteroscopy: a randomised controlled trial.,,2021,,['hysteroscopy'],['Intravenous lidocaine'],[],"[{'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]",[],,0.14566,,"[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Shaobing', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesia, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Warwick D', 'Initials': 'WD', 'LastName': 'Ngan Kee', 'Affiliation': 'Department of Anesthesia and Intensive Care, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China.'}, {'ForeName': 'Xinzhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China. Electronic address: chenxinz@zju.edu.cn.""}]",British journal of anaesthesia,['10.1016/j.bja.2021.07.020']
3262,34424907,Organized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial.,"BACKGROUND


Clinical trials in the research setting have demonstrated that primary human papillomavirus (HPV)-based screening results in greater protection against cervical cancer compared with cytology, but evidence from real-life implementation was missing. To evaluate the effectiveness of HPV-based cervical screening within a real-life screening program, the organized, population-based cervical screening program in the capital region of Sweden offered either HPV- or cytology-based screening in a randomized manner through a randomized healthcare policy (RHP).
METHODS AND FINDINGS


A total of 395,725 women aged 30 to 64 years that were invited for their routine cervical screening visit were randomized without blinding to either cytology-based screening with HPV triage (n = 183,309) or HPV-based screening, with cytology triage (n = 212,416 women) between September 1, 2014 and September 30, 2016 and follow-up through June 30, 2017. The main outcome was non-inferior detection rate of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary outcomes included superiority in CIN2+ detection, screening attendance, and referral to histology. In total, 120,240 had a cervical screening sample on record in the study period in the HPV arm and 99,340 in the cytology arm and were followed for the outcomes of interest. In per-protocol (PP) analyses, the detection rate of CIN2+ was 1.03% (95% confidence interval (CI) 0.98 to 1.10) in the HPV arm and 0.93% (0.87 to 0.99) in the cytology arm (p for non-inferiority <0.0001; odds ratio (OR) 1.11 (95% CI 1.02 to 1.22)). There were 46 cervical cancers detected in the HPV arm (0.04% (0.03 to 0.06)) and 48 cancers detected in the cytology arm (0.05% (0.04 to 0.07)) (p for non-inferiority <0.0001; OR 0.79 (0.53 to 1.18)). Intention-to-screen (ITS) analyses found few differences. In the HPV arm, there was a modestly increased attendance after new invitations (68.56% (68.31 to 68.80) vs. 67.71% (67.43 to 67.98); OR 1.02 (1.00 to 1.03)) and increased rate of referral with completed biopsy (3.89% (3.79 to 4.00) vs. 3.53% (3.42 to 3.65); OR 1.10 (1.05 to 1.15)). The main limitations of this analysis are that only the baseline results are presented, and there was an imbalance in invitations between the study arms.
CONCLUSIONS


In this study, we observed that a real-life RHP of primary HPV-based screening was acceptable and effective when evaluated against cytology-based screening, as indicated by comparable participation, referral, and detection rates.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01511328.",2021,"In the HPV arm, there was a modestly increased attendance after new invitations (68.56% (68.31 to 68.80) vs. 67.71% (67.43 to 67.98); OR 1.02 (1.00 to 1.03)) and increased rate of referral with completed biopsy (3.89% (3.79 to 4.00) vs. 3.53% (3.42 to 3.65); OR 1.10 (1.05 to 1.15)).","['395,725 women aged 30 to 64 years that were invited for their routine cervical screening visit', 'n = 212,416 women) between September 1, 2014 and September 30, 2016 and follow-up through June 30, 2017', 'In total, 120,240 had a cervical screening sample on record in the study period in the HPV arm and 99,340 in the cytology arm and were followed for the outcomes of interest']","['Organized primary human papillomavirus-based cervical screening', 'HPV- or cytology-based screening', 'cytology-based screening with HPV triage (n = 183,309) or HPV-based screening, with cytology triage', 'HPV-based cervical screening within a real-life screening program, the organized, population-based cervical screening program']","['46 cervical cancers', 'superiority in CIN2+ detection, screening attendance, and referral to histology', 'non-inferior detection rate of cervical intraepithelial neoplasia grade 2 or worse (CIN2', 'attendance after new invitations', 'rate of referral with completed biopsy', 'detection rate of CIN2']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]","[{'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",395725.0,0.303123,"In the HPV arm, there was a modestly increased attendance after new invitations (68.56% (68.31 to 68.80) vs. 67.71% (67.43 to 67.98); OR 1.02 (1.00 to 1.03)) and increased rate of referral with completed biopsy (3.89% (3.79 to 4.00) vs. 3.53% (3.42 to 3.65); OR 1.10 (1.05 to 1.15)).","[{'ForeName': 'K Miriam', 'Initials': 'KM', 'LastName': 'Elfström', 'Affiliation': 'Center for Cervical Cancer Prevention, Karolinska University Laboratory, Karolinska University Hospital and Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Eklund', 'Affiliation': 'Center for Cervical Cancer Prevention, Karolinska University Laboratory, Karolinska University Hospital and Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lamin', 'Affiliation': 'Center for Cervical Cancer Prevention, Karolinska University Laboratory, Karolinska University Hospital and Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Öhman', 'Affiliation': 'Regional Cancer Center of Stockholm-Gotland, Cancer Screening Unit, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hortlund', 'Affiliation': 'Center for Cervical Cancer Prevention, Karolinska University Laboratory, Karolinska University Hospital and Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Elfgren', 'Affiliation': 'Department of Obstetrics and Gynecology, Karolinska University Hospital and Division of Obstetrics and Gynecology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Sundström', 'Affiliation': 'Center for Cervical Cancer Prevention, Karolinska University Laboratory, Karolinska University Hospital and Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Dillner', 'Affiliation': 'Center for Cervical Cancer Prevention, Karolinska University Laboratory, Karolinska University Hospital and Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}]",PLoS medicine,['10.1371/journal.pmed.1003748']
3263,34428642,Outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in a community setting: Unpacking comorbidity.,"OBJECTIVE


Comorbidity and subdiagnostic symptoms are understudied for sleep and circadian problems. We evaluated 1) impairment associated with (a) number of sleep and circadian problems and (b) diagnostic threshold (full diagnosis vs. subdiagnostic symptoms), and 2) Transdiagnostic Sleep and Circadian Intervention (TranS-C) outcomes for participants with specific sleep and circadian problems.
METHOD


Community participants (N = 121) with serious mental illness and sleep and circadian problem(s) were randomized to receive TranS-C plus usual care (TranS-C + UC) or usual care plus delayed TranS-C (UC-DT). Overall impairment, psychiatric symptoms, and sleep and circadian dysfunction were assessed at pre-treatment, post-treatment, and 6-month follow-up.
RESULTS


Higher numbers of sleep and circadian problems, versus one problem, were associated with worse overall impairment, psychiatric symptoms, and sleep and circadian dysfunction (ps < 0.05, ω 2  = 0.06-0.15). Diagnostic threshold was not associated with baseline functioning (ps > 0.05). TranS-C + UC versus UC-DT was associated with psychosocial and sleep and circadian improvements for specific sleep and circadian problems (insomnia, hypersomnia, parasomnias, periodic limb movement/restless leg syndrome, circadian rhythm disorders), though improvements varied by problem. TranS-C + UC outcomes were not moderated by number of sleep and circadian problems (ps > 0.05).
CONCLUSION


Higher numbers of sleep and circadian problems, not diagnostic threshold, were associated with greater impairment. Transdiagnostic utility of TranS-C + UC was supported.",2021,"TranS-C + UC versus UC-DT was associated with psychosocial and sleep and circadian improvements for specific sleep and circadian problems (insomnia, hypersomnia, parasomnias, periodic limb movement/restless leg syndrome, circadian rhythm disorders), though improvements varied by problem.","['Community participants (N\xa0=\xa0121) with serious mental illness and sleep and circadian problem(s', 'participants with specific sleep and circadian problems']","['Transdiagnostic Intervention', 'TranS-C\xa0+\xa0UC', 'TranS-C\xa0+\xa0UC versus UC-DT', 'TranS-C plus usual care (TranS-C\xa0+\xa0UC) or usual care plus delayed TranS-C (UC-DT']","['Sleep and Circadian Dysfunction (TranS-C', 'Overall impairment, psychiatric symptoms, and sleep and circadian dysfunction', 'overall impairment, psychiatric symptoms, and sleep and circadian dysfunction', 'specific sleep and circadian problems (insomnia, hypersomnia, parasomnias, periodic limb movement/restless leg syndrome, circadian rhythm disorders', '1) impairment associated with (a) number of sleep and circadian problems and (b) diagnostic threshold (full diagnosis vs. subdiagnostic symptoms), and 2) Transdiagnostic Sleep and Circadian Intervention (TranS-C) outcomes', 'sleep and circadian problems', 'number of sleep and circadian problems']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C0030508', 'cui_str': 'Parasomnia'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0813142', 'cui_str': 'Circadian Dysregulation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",121.0,0.0433567,"TranS-C + UC versus UC-DT was associated with psychosocial and sleep and circadian improvements for specific sleep and circadian problems (insomnia, hypersomnia, parasomnias, periodic limb movement/restless leg syndrome, circadian rhythm disorders), though improvements varied by problem.","[{'ForeName': 'Laurel D', 'Initials': 'LD', 'LastName': 'Sarfan', 'Affiliation': 'University of California, Berkeley, 2121 Berkeley Way, Berkeley, CA, 94720, USA. Electronic address: sarfanld@berkeley.edu.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Hilmoe', 'Affiliation': 'University of California, Berkeley, 2121 Berkeley Way, Berkeley, CA, 94720, USA. Electronic address: heatherhilmoe@berkeley.edu.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Gumport', 'Affiliation': 'University of California, Berkeley, 2121 Berkeley Way, Berkeley, CA, 94720, USA. Electronic address: ngumport@berkeley.edu.'}, {'ForeName': 'Caitlin E', 'Initials': 'CE', 'LastName': 'Gasperetti', 'Affiliation': 'University of California, Berkeley, 2121 Berkeley Way, Berkeley, CA, 94720, USA. Electronic address: cegg@berkeley.edu.'}, {'ForeName': 'Garret G', 'Initials': 'GG', 'LastName': 'Zieve', 'Affiliation': 'University of California, Berkeley, 2121 Berkeley Way, Berkeley, CA, 94720, USA. Electronic address: ggzieve@berkeley.edu.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, 2121 Berkeley Way, Berkeley, CA, 94720, USA. Electronic address: aharvey@berkeley.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103948']
3264,34351035,Effectiveness of a ketogenic diet and virtual coaching intervention for patients with diabetes: A difference-in-differences analysis.,"AIM


To test the effectiveness of a ketogenic diet and virtual coaching intervention in controlling markers of diabetes care and healthcare utilization.
MATERIALS AND METHODS


Using a difference-in-differences analysis with a waiting list control group-a quasi-experimental methodology-we estimated the 5-month change in HbA1c, body mass index, blood pressure, prescription medication use and costs, as well as healthcare utilization. The analysis included 590 patients with diabetes who were also overweight or obese, and who regularly utilize the Veterans Health Administration (VA) for healthcare. We used data from VA electronic health records from 2018 to 2020.
RESULTS


The ketogenic diet and virtual coaching intervention was associated with significant reductions in HbA1c (-0.69 [95% CI -1.02, -0.36]), diabetes medication fills (-0.38, [-0.49, -0.26]), body mass index (-1.07, [-1.95, -0.19]), diastolic blood pressure levels (-1.43, [-2.72, -0.14]), outpatient visits (-0.36, [-0.70, -0.02]) and prescription drug costs (-34.54 [-48.56, -20.53]). We found no significant change in emergency department visits (-0.02 [-0.05, 0.01]) or inpatient admissions (-0.01 [-0.02, 0.01]).
CONCLUSIONS


This real-world assessment of a virtual coaching and diet programme shows that such an intervention offers short-term benefits on markers of diabetes care and healthcare utilization in patients with diabetes.",2021,"The ketogenic diet and virtual coaching intervention was associated with significant reductions in HbA1c (-0.69 [95% CI -1.02, -0.36]), diabetes medication fills (-0.38, [-0.49, -0.26]), body mass index (-1.07, [-1.95, -0.19]), diastolic blood pressure levels (-1.43, [-2.72, -0.14]), outpatient visits (-0.36, [-0.70, -0.02]) and prescription drug costs (-34.54","['590 patients with diabetes who were also overweight or obese, and who regularly utilize the Veterans Health Administration (VA) for healthcare', 'patients with diabetes']",['ketogenic diet and virtual coaching intervention'],"['emergency department visits', 'body mass index', 'prescription drug costs', 'diastolic blood pressure levels', 'inpatient admissions', 'diabetes medication fills', 'outpatient visits', '5-month change in HbA1c, body mass index, blood pressure, prescription medication use and costs, as well as healthcare utilization']","[{'cui': 'C5191356', 'cui_str': '590'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",590.0,0.0574369,"The ketogenic diet and virtual coaching intervention was associated with significant reductions in HbA1c (-0.69 [95% CI -1.02, -0.36]), diabetes medication fills (-0.38, [-0.49, -0.26]), body mass index (-1.07, [-1.95, -0.19]), diastolic blood pressure levels (-1.43, [-2.72, -0.14]), outpatient visits (-0.36, [-0.70, -0.02]) and prescription drug costs (-34.54","[{'ForeName': 'Kiersten L', 'Initials': 'KL', 'LastName': 'Strombotne', 'Affiliation': 'Department of Health Law, Policy and Management, Boston University of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lum', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, USA.'}, {'ForeName': 'Nambi J', 'Initials': 'NJ', 'LastName': 'Ndugga', 'Affiliation': 'Department of Health Law, Policy and Management, Boston University of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Utech', 'Affiliation': 'Veterans Health Administration, Department of Veterans Affairs, Washington, District of Columbia, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Pizer', 'Affiliation': 'Department of Health Law, Policy and Management, Boston University of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Austin B', 'Initials': 'AB', 'LastName': 'Frakt', 'Affiliation': 'Department of Health Law, Policy and Management, Boston University of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Conlin', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14515']
3265,34411756,A Prospective Randomized Controlled Trial to Compare the Use of Conventional Dark-Ink Tattoo and Ultraviolet-Ink Tattoo for Patients Undergoing Breast Radiation Therapy.,"PURPOSE


Permanent tattoo marks used in radiation therapy remain for the duration of treatment and essentially for the rest of the patient's life. This study compared the initial positioning setup errors and body image perception between patients with ultraviolet (UV) and conventional dark ink tattoos.
METHODS AND MATERIALS


Thirty-four patients from February 2018 to March 2019, who underwent radiation therapy (RT) to the breast or chest wall for ductal carcinoma in situ or breast cancer were prospectively recruited and randomized (1:1) to receive either conventional dark ink or UV ink tattoos. Each patient received the assigned tattoos during computed tomography (CT) simulation and initial treatment setup shifts were compared. A 9-item body-image survey was administered to all patients at 3 time points: CT simulation, last week of RT, and 6 weeks post-RT. Feedback from CT and treatment staff in terms of setup time and challenges were collated.
RESULTS


The median age of the patient cohort was 46 years old. No statistically significant difference was observed between the mean setup errors for the conventional dark ink group (0.11 cm inferior, 0.01 cm left, 0.11 cm posterior) and UV ink group (0.01 cm superior, 0.01 cm right, 0.06 cm posterior; P = NS). Similar responses were observed in the body-image survey between the 2 groups across all time points (P = NS). The majority of the patients (dark ink 82.3% vs UV ink 88.2%) did not feel less sexually attractive as a result of the tattoo at 6 weeks post-RT. At 6 weeks post-RT, patients in both groups were satisfied with the appearance of the tattoo and did not feel cautious about their choice of clothes (82.4% vs 88.2%; P = NS). In addition, 88.6% of staff (n = 35) felt minimum effect of UV ink on the overall setup time, and 94.3% found no difficulty localizing the UV ink tattoos during patient positioning.
CONCLUSIONS


No difference in setup accuracy was found using UV ink tattoos, and it could be implemented clinically with minimal effect on the existing workflow. Patients expressed high satisfaction and self-confidence with the use of UV ink tattoos.",2021,No difference in setup accuracy was found using UV ink tattoos and it could be implemented clinically with minimal impact on the existing workflow.,"['Thirty-four patients from February 2018 to March 2019, who underwent radiotherapy (RT) to the breast or chest wall for ductal carcinoma in-situ (DCIS) or breast cancer', 'patients undergoing breast radiotherapy', 'patients with ultraviolet (UV) and conventional dark ink tattoos']","['conventional dark ink or UV ink tattoos', 'conventional dark ink tattoo and ultra-violet ink tattoo']","['mean setup errors', 'setup accuracy']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0852216', 'cui_str': 'Breast radiotherapies'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0181353', 'cui_str': 'Tissue marking ink'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0021510', 'cui_str': 'Ink'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0181353', 'cui_str': 'Tissue marking ink'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",34.0,0.0166071,No difference in setup accuracy was found using UV ink tattoos and it could be implemented clinically with minimal impact on the existing workflow.,"[{'ForeName': 'Li Hoon', 'Initials': 'LH', 'LastName': 'Lim', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, Hospital Crescent, Singapore. Electronic address: lim.l.h@nccs.com.sg.'}, {'ForeName': 'Eric Pei Ping', 'Initials': 'EPP', 'LastName': 'Pang', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, Hospital Crescent, Singapore.'}, {'ForeName': 'Rehena', 'Initials': 'R', 'LastName': 'Sultana', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kusumawidjaja', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, Hospital Crescent, Singapore; Duke-NUS Graduate Medical School, Singapore.'}, {'ForeName': 'Ru Xin', 'Initials': 'RX', 'LastName': 'Wong', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, Hospital Crescent, Singapore; Duke-NUS Graduate Medical School, Singapore.'}, {'ForeName': 'Richard Ming Chert', 'Initials': 'RMC', 'LastName': 'Yeo', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, Hospital Crescent, Singapore; Duke-NUS Graduate Medical School, Singapore.'}, {'ForeName': 'Bryan Shihan', 'Initials': 'BS', 'LastName': 'Ho', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, Hospital Crescent, Singapore; Duke-NUS Graduate Medical School, Singapore.'}, {'ForeName': 'Wee Loon', 'Initials': 'WL', 'LastName': 'Ng', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, Hospital Crescent, Singapore; Duke-NUS Graduate Medical School, Singapore.'}, {'ForeName': 'Faye Lynette Wei Tching', 'Initials': 'FLWT', 'LastName': 'Lim', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, Hospital Crescent, Singapore; Duke-NUS Graduate Medical School, Singapore.'}, {'ForeName': 'Eu Tiong', 'Initials': 'ET', 'LastName': 'Chua', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, Hospital Crescent, Singapore; Duke-NUS Graduate Medical School, Singapore.'}, {'ForeName': 'Avelyn Yun Fang', 'Initials': 'AYF', 'LastName': 'Sim', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, Hospital Crescent, Singapore.'}, {'ForeName': 'Fuh Yong', 'Initials': 'FY', 'LastName': 'Wong', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, Hospital Crescent, Singapore; Duke-NUS Graduate Medical School, Singapore.'}]",Practical radiation oncology,['10.1016/j.prro.2021.08.001']
3266,34431708,SKOPE-Study of Ketorolac vs Opioid for Pain after Endoscopy: A Double-Blinded Randomized Control Trial in Patients Undergoing Ureteroscopy. Reply.,,2021,,['Patients Undergoing Ureteroscopy'],['Ketorolac vs Opioid'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",[],,0.767149,,"[{'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Sivalingam', 'Affiliation': 'Glickman Urological & Kidney Institute,Cleveland Clinic, Cleveland, Ohio.'}]",The Journal of urology,['10.1097/JU.0000000000002194']
3267,34431707,SKOPE-Study of Ketorolac vs Opioid for Pain after Endoscopy: A Double-Blinded Randomized Control Trial in Patients Undergoing Ureteroscopy. Letter.,,2021,,['Patients Undergoing Ureteroscopy'],['Ketorolac vs Opioid'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",[],,0.786653,,"[{'ForeName': 'Geoffrey H', 'Initials': 'GH', 'LastName': 'Rosen', 'Affiliation': 'Division of Urology, Department of Surgery, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Hargis', 'Affiliation': 'School of Medicine, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Katie S', 'Initials': 'KS', 'LastName': 'Murray', 'Affiliation': 'Division of Urology, Department of Surgery, University of Missouri, Columbia, Missouri.'}]",The Journal of urology,['10.1097/JU.0000000000002193']
3268,34431612,Scalp acupuncture enhances local brain regions functional activities and functional connections between cerebral hemispheres in acute ischemic stroke patients.,"This study aimed to explore the changes in functional connections between cerebral hemispheres and local brain regions functional activities in patients with acute ischemic stroke (AIS) treated with International Standard Scalp Acupuncture (ISSA). Thirty patients with middle cerebral artery AIS in the dominant hemisphere were selected and randomly divided into two groups such as the control group and the scalp acupuncture group, with 15 patients in each group. Patients in the control group were treated with conventional Western medicine, while patients in the scalp acupuncture group received ISSA (acupuncture at the parietal midline [MS5], acupuncture at the left anterior parietotemporal oblique line [MS6] and acupuncture at the left posterior parietotemporal oblique line [MS7]) for one course of treatment. All patients were evaluated for treatment efficacy and received whole brain resting state functional magnetic resonance imaging (Rs-fMRI) scan before and after treatment. The observational indicators included: (a) the National Institutes of Health Stroke Scale (NIHSS) scores and the simplified Fugl-Meyer Assessment (SFMA) scores; (b) analyses of the amplitude of low-frequency fluctuation (ALFF), regional homogeneity (ReHo) and voxel-mirrored homotopic connectivity (VMHC). The results showed a significant difference in the NIHSS scores before and after treatment in the scalp acupuncture group compared with the control group (p < .05), indicating that patients improved better after scalp acupuncture treatment. Compared with the control group, the VMHC, ALFF and ReHo values in the scalp acupuncture group increased after treatment. The VMHC values increased in the brain regions dominated by bilateral BA6 and BA8; the ALFF values increased in the left BA39 and the adjacent superior temporal gyrus and middle temporal gyrus; and the ReHo values increased in the brain regions extending from left middle temporal gyrus (including BA21) to BA37, and the brain regions extending from the left BA40 and angular gyrus to BA7. The present study indicated that scalp acupuncture can specifically strengthen the functional activities of the brain regions related to sensory integration, language processing and motor coordination in the middle aged and elderly patients with AIS of the dominant cerebral hemisphere, and can strengthen bilateral frontal lobe motor control. This study may provide a scientific basis for the clinical application of ISSA treatment in patients with AIS, and may also provide a preliminary research basis for further animal experiments.",2021,"Compared with the control group, the VMHC, ALFF and ReHo values in the scalp acupuncture group increased after treatment.","['middle aged and elderly patients with AIS of the dominant cerebral hemisphere', 'patients with acute ischemic stroke (AIS) treated with', 'patients with AIS', 'Thirty patients with middle cerebral artery AIS in the dominant hemisphere', 'acute ischemic stroke patients']","['ISSA', 'International Standard Scalp Acupuncture (ISSA', 'cerebral hemispheres and local brain regions functional activities', 'scalp acupuncture', 'Scalp acupuncture', 'whole brain resting state functional magnetic resonance imaging (Rs-fMRI) scan', 'conventional Western medicine', 'scalp acupuncture group received ISSA (acupuncture at the parietal midline [MS5], acupuncture at the left anterior parietotemporal oblique line [MS6] and acupuncture at the left posterior parietotemporal oblique line [MS7']","['VMHC values', 'NIHSS scores', 'National Institutes of Health Stroke Scale (NIHSS) scores and the simplified Fugl-Meyer Assessment (SFMA) scores; (b) analyses of the amplitude of low-frequency fluctuation (ALFF), regional homogeneity (ReHo) and voxel-mirrored homotopic connectivity (VMHC', 'ALFF values', 'VMHC, ALFF and ReHo values', 'ReHo values']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0228174', 'cui_str': 'Cerebral hemisphere structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0228174', 'cui_str': 'Cerebral hemisphere structure'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",30.0,0.056556,"Compared with the control group, the VMHC, ALFF and ReHo values in the scalp acupuncture group increased after treatment.","[{'ForeName': 'Huacong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yijing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Rehabilitation Medicine, Rehabilitation Hospital, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'The Community Health Service Center of Houjie Town, Dongguan, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Lanpin', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jingchun', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Rehabilitation Medicine, Third Affiliated Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jiping', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Songyan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Third Affiliated Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Third Affiliated Hospital of Southern Medical University, Guangzhou, China.'}]","Anatomical record (Hoboken, N.J. : 2007)",['10.1002/ar.24746']
3269,34428929,Effect of ACEI and ARB treatment on nitric oxide-dependent endothelial function.,"Background:  Angiotensin-converting-enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARB) are widely used as a first-line therapy for the treatment of cardiovascular disease. Here, ACEI modulate the bradykinin receptor (BDKRB1 and BDKRB2) system and NO-dependent endothelial function, thus determining cardiovascular health and regenerative arteriogenesis. The current study aims at evaluating nitric oxide-dependent endothelial function, and gene expression of bradykinin receptors in peripheral blood mononuclear cells (PBMC) from patients with ACEI or ARB treatment.  Patients and methods:  The WalkByLab has been established to screen cardiovascular patients for peripheral artery disease and coronary artery disease. In total 177 patients from WalkByLab with heterogenous disease and risk status were randomly selected, divided according to their medication history into the following groups: 1. ACEI group, 2. ARB group or 3. non-ACE/ARB group. Total plasma nitrite/nitrate (NO) levels were measured, endothelial function was evaluated by assessing flow meditated dilation (FMD). PBMC were isolated from peripheral whole blood, and gene expression (qRT-PCR) of bradykinin receptors and angiotensin converting enzyme were assessed.  Results:  Plasma total NO concentration in the ACEI group (24.66±16.28, µmol/l) was increased as compared to the ARB group (18.57±11.58, µmol/l,  P =0.0046) and non-ACE/ARB group (16.83±8.64, µmol/l,  P =0.0127) in patients between 40 to 90 years of age. However, FMD values (%) in the ACEI group (7.07±2.40, %) were similar as compared to the ARB (6.35±2.13, %) and non-ACE/ARB group (6.51±2.15, %), but significantly negatively correlated with age. Interestingly, BDKRB1 mRNA level was significantly higher and BDKRB2 mRNA level lower in the ACEI group (BDKRB1 3.88-fold±1.05, BDKRB2 0.22-fold±0.04) as compared to the non-ACE/ARB group (BDKRB1 1.00-fold±0.39,  P <0.0001, BDKRB2 1.00-fold±0.45,  P =0.0136).  Conclusions:  ACEI treatment enhances total nitrite/nitrate concentration, furthermore, upregulates BDKRB1 in PBMC, but downregulates BDKRB2 mRNA expression. FMD is a strong determinant of vascular aging and is sensitive to underlying heterogenous cardiovascular diseases.",2021,"NO concentration in the ACEI group (24.66±16.28, µmol/l) was increased as compared to the ARB group (18.57±11.58, µmol/l,  P =0.0046) and non-ACE/ARB group (16.83±8.64, µmol/l,  P =0.0127) in patients between 40 to 90 years of age.","['patients with ACEI or ARB treatment', 'In total 177 patients from WalkByLab with heterogenous disease and risk status']","['ACEI and ARB', 'Angiotensin-converting-enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARB', 'ACEI', 'WalkByLab', 'ARB']","['BDKRB1 mRNA level', 'FMD values', 'Total plasma nitrite/nitrate (NO) levels', 'nitric oxide-dependent endothelial function', 'endothelial function', 'total nitrite/nitrate concentration, furthermore, upregulates BDKRB1 in PBMC', 'Plasma total', 'NO concentration', 'BDKRB2 mRNA level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]",177.0,0.0183451,"NO concentration in the ACEI group (24.66±16.28, µmol/l) was increased as compared to the ARB group (18.57±11.58, µmol/l,  P =0.0046) and non-ACE/ARB group (16.83±8.64, µmol/l,  P =0.0127) in patients between 40 to 90 years of age.","[{'ForeName': 'Kangbo', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department for Angiology, Center for Internal Medicine I, Brandenburg Medical School Theodor Fontane, Campus University Clinic Brandenburg, Deutsches Angiologie Zentrum Brandenburg-Berlin (DAZB), Brandenburg an der Havel, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Zemmrich', 'Affiliation': 'Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bramlage', 'Affiliation': 'Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.'}, {'ForeName': 'Anja Bondke', 'Initials': 'AB', 'LastName': 'Persson', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Mesud', 'Initials': 'M', 'LastName': 'Sacirovic', 'Affiliation': 'Department for Angiology, Center for Internal Medicine I, Brandenburg Medical School Theodor Fontane, Campus University Clinic Brandenburg, Deutsches Angiologie Zentrum Brandenburg-Berlin (DAZB), Brandenburg an der Havel, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Ritter', 'Affiliation': 'Department for Cardiology, Center for Internal Medicine I, Brandenburg Medical School Theodor Fontane, Campus University Clinic Brandenburg, Brandenburg an der Havel, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Buschmann', 'Affiliation': 'Department of Cardiology, University Clinic Graz, Austria.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Buschmann', 'Affiliation': 'Department for Angiology, Center for Internal Medicine I, Brandenburg Medical School Theodor Fontane, Campus University Clinic Brandenburg, Deutsches Angiologie Zentrum Brandenburg-Berlin (DAZB), Brandenburg an der Havel, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hillmeister', 'Affiliation': 'Department for Angiology, Center for Internal Medicine I, Brandenburg Medical School Theodor Fontane, Campus University Clinic Brandenburg, Deutsches Angiologie Zentrum Brandenburg-Berlin (DAZB), Brandenburg an der Havel, Germany.'}]",VASA. Zeitschrift fur Gefasskrankheiten,['10.1024/0301-1526/a000971']
3270,34402157,"Glucose control using fast-acting insulin aspart in a real-world setting: A 1-year, two-centre study in people with type 1 diabetes using continuous glucose monitoring.","AIM


To evaluate the efficacy and safety of switching from traditional mealtime insulins to fast-acting insulin aspart (Fiasp) in a ""real-world"" clinical practice setting in adult people with type 1 diabetes (PWD1) who were using intermittently scanned or real-time continuous glucose monitoring (isCGM or rtCGM, respectively).
MATERIALS AND METHODS


Data from 438 adult PWD1 (60% men, age 44.6 ± 16.2 years, diabetes duration 21.5 ± 14.0 years, isCGM/rtCGM: 391/47, multiple daily injections/continuous subcutaneous insulin infusion: 409/29), who initiated Fiasp from January 2018 to May 2020, were analysed. The primary objective was the evolution of time in range (TIR; 70-180 mg/dL) at 6 and 12 months. Secondary objectives included change in HbA1c, body mass index (BMI), insulin doses, time below range (<70 and <54 mg/dL), and time above range (>180 and >250 mg/dL).
RESULTS


TIR improved from 50.3% ± 15.6% to 54.3% ± 15.1% at 6 months (n = 425) and to 55.5% ± 15.2% at 12 months (n = 385) (P < .001), corresponding to 57 min/d at 6 months and 75 min/d at 12 months. Time spent below 54 mg/dL evolved from 3.1% ± 3.3% to 3.1% ± 3.7% and 2.5% ± 3.0% at 6 and 12 months, respectively (P = .011). Also, time spent above 180 mg/dL decreased from 42.3% ± 16.7% at start by 4.2% at 6 months and by 4.6% at 12 months (P < .001). The proportion of people reaching TIR more than 70% increased from 11.0% to 14.8% (P = .002), and those spending less than 4% at time less than 70 mg/dL increased from 36.1% to 42.1% (P = .002). After 12 months, HbA1c, insulin doses, and BMI did not change significantly.
CONCLUSIONS


In a Belgian real-world setting of adult PWD1, switching to Fiasp was associated with a 5% increased TIR after 12 months, corresponding to 75 min/d, in combination with less time spent below and above range.",2021,"RESULTS


TIR improved from 50.3% ± 15.6% to 54.3% ± 15.1% at 6 months (n = 425) and to 55.5% ± 15.2% at 12 months (n = 385) (P < .001), corresponding to 57 min/d at 6 months and 75 min/d at 12 months.","['adult people with type 1 diabetes (PWD1) who were using intermittently scanned or real-time continuous glucose monitoring (isCGM or rtCGM, respectively', 'people with type 1 diabetes using continuous glucose monitoring', 'Data from 438 adult PWD1 (60% men, age 44.6\xa0±\u200916.2\u2009years, diabetes duration 21.5\xa0±\u200914.0\u2009years, isCGM/rtCGM: 391/47, multiple daily injections/continuous subcutaneous insulin infusion: 409/29), who initiated Fiasp from January 2018 to May 2020, were analysed']","['switching from traditional mealtime insulins to fast-acting insulin aspart (Fiasp', 'Glucose control using fast-acting insulin aspart']","['TIR', 'efficacy and safety', 'HbA1c, insulin doses, and BMI', 'change in HbA1c, body mass index (BMI), insulin doses, time below range', 'evolution of time in range (TIR', 'Time spent']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}]",,0.0561203,"RESULTS


TIR improved from 50.3% ± 15.6% to 54.3% ± 15.1% at 6 months (n = 425) and to 55.5% ± 15.2% at 12 months (n = 385) (P < .001), corresponding to 57 min/d at 6 months and 75 min/d at 12 months.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Billion', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Charleer', 'Affiliation': 'Department of Endocrinology, University Hospitals Leuven-KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Verbraeken', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Sterckx', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Kato', 'Initials': 'K', 'LastName': 'Vangelabbeek', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'De Block', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Charlien', 'Initials': 'C', 'LastName': 'Janssen', 'Affiliation': 'Department of Endocrinology, University Hospitals Leuven-KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Kristof', 'Initials': 'K', 'LastName': 'Van Dessel', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Dirinck', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Peiffer', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bolsens', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Department of Endocrinology, University Hospitals Leuven-KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Gillard', 'Affiliation': 'Department of Endocrinology, University Hospitals Leuven-KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'De Block', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14527']
3271,34418116,"Efficacy and safety of arimoclomol in Niemann-Pick disease type C: Results from a double-blind, randomised, placebo-controlled, multinational phase 2/3 trial of a novel treatment.","Niemann-Pick disease type C (NPC) is a rare, genetic, progressive neurodegenerative disorder with high unmet medical need. We investigated the safety and efficacy of arimoclomol, which amplifies the heat shock response to target NPC protein misfolding and improve lysosomal function, in patients with NPC. In a 12-month, prospective, randomised, double-blind, placebo-controlled, phase 2/3 trial (ClinicalTrials.gov identifier: NCT02612129), patients (2-18 years) were randomised 2:1 to arimoclomol:placebo, stratified by miglustat use. Routine clinical care was maintained. Arimoclomol was administered orally three times daily. The primary endpoint was change in 5-domain NPC Clinical Severity Scale (NPCCSS) score from baseline to 12 months. Fifty patients enrolled; 42 completed. At month 12, the mean progression from baseline in the 5-domain NPCCSS was 0.76 with arimoclomol vs 2.15 with placebo. A statistically significant treatment difference in favour of arimoclomol of -1.40 (95% confidence interval: -2.76, -0.03; P = .046) was observed, corresponding to a 65% reduction in annual disease progression. In the prespecified subgroup of patients receiving miglustat as routine care, arimoclomol resulted in stabilisation of disease severity over 12 months with a treatment difference of -2.06 in favour of arimoclomol (P = .006). Adverse events occurred in 30/34 patients (88.2%) receiving arimoclomol and 12/16 (75.0%) receiving placebo. Fewer patients had serious adverse events with arimoclomol (5/34, 14.7%) vs placebo (5/16, 31.3%). Treatment-related serious adverse events (n = 2) included urticaria and angioedema. Arimoclomol provided a significant and clinically meaningful treatment effect in NPC and was well tolerated.",2021,A statistically significant treatment difference in favour of arimoclomol of -1.40,"['patients with NPC', 'Niemann-Pick disease type C', 'patients (2-18\u2009years', 'Fifty patients enrolled; 42 completed']","['arimoclomol:placebo', 'placebo', 'Arimoclomol', 'arimoclomol']","['mean progression', 'stabilization of disease severity', 'annual disease progression', 'Efficacy and safety', 'Adverse events', 'tolerated', 'urticaria and angioedema', 'serious adverse events', '5-domain NPC Clinical Severity Scale (NPCCSS) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220756', 'cui_str': 'Niemann-Pick disease, type C'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1451975', 'cui_str': 'arimoclomol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0002994', 'cui_str': 'Angioedema'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0220756', 'cui_str': 'Niemann-Pick disease, type C'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.514549,A statistically significant treatment difference in favour of arimoclomol of -1.40,"[{'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Mengel', 'Affiliation': 'SphinCS GmbH, Institute of Clinical Science for LSD, Hochheim, Germany.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Patterson', 'Affiliation': 'Departments of Neurology, Pediatrics and Medical Genetics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Rosalia M', 'Initials': 'RM', 'LastName': 'Da Riol', 'Affiliation': ""Regional Coordination Center for Rare Diseases, Academic Hospital 'Santa Maria della Misericordia', Udine, Italy.""}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Del Toro', 'Affiliation': ""Pediatric Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Deodato', 'Affiliation': 'Division of Metabolism, Ospedale Pediatrico Bambino Gesù, IRCCS, Rome, Italy.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gautschi', 'Affiliation': 'Department of Paediatrics, Division of Endocrinology, Diabetology and Metabolism, and Institute of Clinical Chemistry, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Grunewald', 'Affiliation': 'Department of Metabolic Medicine, Great Ormond Street Hospital, Institute of Child Health, UCL, NIHR Biomedical Research Center, London, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Grønborg', 'Affiliation': 'Centre for Inherited Metabolic Diseases, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harmatz', 'Affiliation': ""Gastroenterology and Hepatology, UCSF Benioff Children's Hospital Oakland, Oakland, California, USA.""}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Héron', 'Affiliation': 'Department of Pediatric Neurology, Reference Centre for Lysosomal Diseases, University Hospital Armand Trousseau, Paris, France.'}, {'ForeName': 'Esther M', 'Initials': 'EM', 'LastName': 'Maier', 'Affiliation': ""Department of Inborn Errors of Metabolism, University of Munich Children's Hospital, Munich, Germany.""}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Roubertie', 'Affiliation': 'Department of Neuropediatrics, Centre Hospitalier Universitaire de Montpellier, Montpellier, France.'}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Santra', 'Affiliation': ""Department of Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tylki-Szymanska', 'Affiliation': ""Department of Paediatrics, Nutrition and Metabolic Diseases, The Children's Memorial Institute, Warsaw, Poland.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Day', 'Affiliation': 'Biostatistics, Clinical Trials Consulting & Training Limited, Buckingham, UK.'}, {'ForeName': 'Anne Katrine', 'Initials': 'AK', 'LastName': 'Andreasen', 'Affiliation': 'Orphazyme A/S, Copenhagen, Denmark.'}, {'ForeName': 'Marie Aavang', 'Initials': 'MA', 'LastName': 'Geist', 'Affiliation': 'Orphazyme A/S, Copenhagen, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Havnsøe Torp Petersen', 'Affiliation': 'Orphazyme A/S, Copenhagen, Denmark.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ingemann', 'Affiliation': 'Orphazyme A/S, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Orphazyme A/S, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Blaettler', 'Affiliation': 'Orphazyme A/S, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kirkegaard', 'Affiliation': 'Orphazyme A/S, Copenhagen, Denmark.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Í Dali', 'Affiliation': 'Orphazyme A/S, Copenhagen, Denmark.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12428']
3272,33337729,Safety and Efficacy of Pharmaco-invasive Approach Using Streptokinase Compared With Primary Percutaneous Coronary Angiography.,"BACKGROUND


Fibrin-specific fibrinolytics are preferred when they used in STEMI patients (pharmaco-invasive approach). However, streptokinase is still the most common used thrombolytic agent in Egypt because of its cheaper cost.
METHODS


266 STEMI patients were randomly assigned to undergo PPCI or pharmacoinvasive (using streptokinase). Primary end point (death, shock, congestive heart failure, or reinfarction up to 30 d) and secondary end point (ischemic stroke, intracranial hemorrhage, or nonintracranial bleeding) were followed for 30 days after reperfusion. In pharmaco-invasive arm, urgent coronary angiography was performed in case of failed reperfusion. Based on the reperfusion time from symptoms onset, patients in both arms were divided into; early (≤3 hrs) and late reperfusion (>3 hrs).
RESULTS


No statistical significant difference regarding left ventricular ejection fraction, end diastolic and end systolic diameter in both arms. Early PPCI (≤3 hrs) had highest ejection fraction values (56.9 ± 7.5). Myocardial wall preservation was best achieved in early pharmaco-invasive (≤3 hrs).There was no statistical significant difference in TIMI flow results between all subgroups (early and late of both arms) (P = 0.750). Suction devices and IV Eptifibatide were less frequently used in the pharmaco-invasive comparing to PPCI arm; (P = 0.000 and P = 0.006) subsequently. No statistical significant difference regarding complication incidence in both arms (P = 0.518). Radial access was more commonly used in the pharmaco-invasive arm (P = 0.015).
CONCLUSION


Utilizing streptokinase in early re-perfused patients by PI approach (≤3 hrs) seems safe and efficient when PPCI delay (>120 min from symptom onset) is the other option.",2021,Suction devices and IV Eptifibatide were less frequently used in the pharmaco-invasive comparing to PPCI arm;,"['266 STEMI patients', 'STEMI patients (pharmaco-invasive approach']","['Suction devices and IV Eptifibatide', 'streptokinase', 'PPCI or pharmacoinvasive (using streptokinase', 'Pharmaco-invasive Approach Using Streptokinase', 'Utilizing streptokinase', 'Primary Percutaneous Coronary Angiography']","['death, shock, congestive heart failure, or reinfarction up to 30 d) and secondary end point (ischemic stroke, intracranial hemorrhage, or nonintracranial bleeding', 'complication incidence', 'Radial access', 'Safety and Efficacy', 'Myocardial wall preservation', 'TIMI flow results', 'highest ejection fraction values', 'left ventricular ejection fraction, end diastolic and end systolic diameter']","[{'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0253563', 'cui_str': 'eptifibatide'}, {'cui': 'C0038418', 'cui_str': 'Streptokinase'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",266.0,0.0339435,Suction devices and IV Eptifibatide were less frequently used in the pharmaco-invasive comparing to PPCI arm;,"[{'ForeName': 'El-Zahraa M', 'Initials': 'EM', 'LastName': 'Sultan', 'Affiliation': 'From the Cardiology Department, Beni-Suef University Hospital, Beni-Suef, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Elberry', 'Affiliation': 'Pharmacology Department, Faculty of Medicine, Beni-Suef University Hospital, Beni-Suef, Egypt.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Rabea', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Hesham B', 'Initials': 'HB', 'LastName': 'Mahmoud', 'Affiliation': 'Beni-Suef University Hospital, Beni-Suef, Egypt.'}]",Critical pathways in cardiology,['10.1097/HPC.0000000000000250']
3273,34427732,Metabolic effects of high-intensity interval training and essential amino acids.,"High-intensity interval training (HIIT) promotes positive cardiometabolic and body composition changes. Essential amino acids (EAA) may support changes associated with HIIT, but evaluation of potential synergistic effects is lacking. The purpose of this study was to compare independent and combined effects of HIIT and EAA on total body composition and metabolism in men and women considered overweight/obese; an exploratory aim was to evaluate the modulatory effects of sex. Sixty-six healthy adults (50% female; Age: 36.7 ± 6.0 years; BMI: 32.0 ± 4.2 kg/m 2 ) completed 8 weeks of: (1) HIIT, 2 days/weeks; (2) EAA supplementation, 3.6 g twice daily; (3) HIIT + EAA; or (4) control. Body composition, resting metabolic rate (RMR), substrate metabolism (respiratory exchange ratio; RER), and cardiorespiratory fitness were measured at baseline, 4 weeks, and 8 weeks; cardiometabolic blood markers were measured at baseline and 8 weeks. Differences between groups were assessed by linear mixed models covaried for baseline values, followed by 95% confidence intervals (CI) on adjusted mean change scores. There were no significant changes in body composition (p > 0.05) for any group. Changes in RER, but not RMR, occurred with HIIT (mean change; [95% CI]: - 0.04; [- 0.07, - 0.02]) and EAA (- 0.03; [- 0.06, - 0.01]) after 8 weeks. Cardiorespiratory fitness increased following 8 weeks of HIIT (+ 5.1 ml/kg/min [3.3,6.8]) and HIIT + EAA (+ 4.1 ml/kg/min [1.0,6.4]). Changes with HIIT + EAA were not significantly different from HIIT. There were no changes in cardiometabolic markers (p > 0.05) and no sex interaction (p > 0.05). HIIT is efficacious for promoting positive changes in cardiorespiratory fitness and resting substrate metabolism in adults considered overweight/obese. Addition of EAA did not significantly enhance HIIT-induced adaptations. ClinicalTrials.gov ID#NCT04080102.",2021,HIIT is efficacious for promoting positive changes in cardiorespiratory fitness and resting substrate metabolism in adults considered overweight/obese.,"['adults considered overweight/obese', 'Sixty-six healthy adults (50% female; Age: 36.7\u2009±\u20096.0 years; BMI: 32.0\u2009±\u20094.2\xa0kg/m 2 ', 'men and women considered overweight/obese']","['Essential amino acids (EAA', 'EAA supplementation, 3.6\xa0g twice daily; (3) HIIT\u2009+\u2009EAA', 'HIIT and EAA', 'EAA', 'High-intensity interval training (HIIT', 'high-intensity interval training and essential amino acids']","['body composition', 'total body composition and metabolism', 'Cardiorespiratory fitness', 'cardiometabolic blood markers', 'cardiometabolic markers', 'Body composition, resting metabolic rate (RMR), substrate metabolism (respiratory exchange ratio; RER), and cardiorespiratory fitness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}]",66.0,0.127432,HIIT is efficacious for promoting positive changes in cardiorespiratory fitness and resting substrate metabolism in adults considered overweight/obese.,"[{'ForeName': 'Katie R', 'Initials': 'KR', 'LastName': 'Hirsch', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging and Longevity, University of Arkansas for Medical Sciences, Little Rock, AR, USA. krhirsch@uams.edu.'}, {'ForeName': 'Casey E', 'Initials': 'CE', 'LastName': 'Greenwalt', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Cabre', 'Affiliation': 'Applied Physiology Laboratory, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lacey M', 'Initials': 'LM', 'LastName': 'Gould', 'Affiliation': 'Applied Physiology Laboratory, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Gabrielle J', 'Initials': 'GJ', 'LastName': 'Brewer', 'Affiliation': 'Department of Kinesiology, Korey Stringer Institute, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Malia N M', 'Initials': 'MNM', 'LastName': 'Blue', 'Affiliation': 'Applied Physiology Laboratory, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Arny A', 'Initials': 'AA', 'LastName': 'Ferrando', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging and Longevity, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Huffman', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Mayer-Davis', 'Affiliation': 'Department of Nutrition, Gillings School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Ryan', 'Affiliation': 'Department of Allied Health Science, Human Movement Science Curriculum, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Abbie E', 'Initials': 'AE', 'LastName': 'Smith-Ryan', 'Affiliation': 'Applied Physiology Laboratory, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",European journal of applied physiology,['10.1007/s00421-021-04792-4']
3274,34426097,Clinical Trial Protocol for a Randomized Trial of Community Health Worker-led Decision Coaching to Promote Shared Decision-making on Prostate Cancer Screening Among Black Male Patients and Their Providers.,We propose a randomized controlled trial to evaluate the effectiveness of a community health worker-led decision-coaching program to facilitate shared decision-making for prostate cancer screening decisions by Black men at a primary care federally qualified health center.,2021,We propose a randomized controlled trial to evaluate the effectiveness of a community health worker-led decision-coaching program to facilitate shared decision-making for prostate cancer screening decisions by Black men at a primary care federally qualified health center.,"['Black men at a primary care federally qualified health center', 'Black Male Patients and Their Providers']","['Community Health Worker-led Decision Coaching to Promote Shared Decision-making on Prostate Cancer Screening', 'community health worker-led decision-coaching program']",[],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.138878,We propose a randomized controlled trial to evaluate the effectiveness of a community health worker-led decision-coaching program to facilitate shared decision-making for prostate cancer screening decisions by Black men at a primary care federally qualified health center.,"[{'ForeName': 'Danil V', 'Initials': 'DV', 'LastName': 'Makarov', 'Affiliation': 'VA New York Harbor Healthcare System, New York, NY, USA; Department of Urology, NYU Langone Health, New York, NY, USA; Department of Population Health, NYU Langone Health, New York, NY, USA. Electronic address: danil.makarov@nyulangone.org.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Ciprut', 'Affiliation': 'VA New York Harbor Healthcare System, New York, NY, USA; Department of Urology, NYU Langone Health, New York, NY, USA; Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Martinez-Lopez', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Shedlin', 'Affiliation': 'NYU College of Nursing, New York, NY, USA.'}, {'ForeName': 'Heather T', 'Initials': 'HT', 'LastName': 'Gold', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Huilin', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bhat', 'Affiliation': 'Sunset Park Health Council, Brooklyn, New York, NY, USA.'}, {'ForeName': 'Rueben', 'Initials': 'R', 'LastName': 'Warren', 'Affiliation': 'National Center for Bioethics in Research and Health Care, Tuskegee University, Tuskegee, AL, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ubel', 'Affiliation': 'The Fuqua School of Business, Duke University, Durham, NC, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Ravenell', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}]",European urology focus,['10.1016/j.euf.2021.08.001']
3275,34431170,Baseline characteristics and effects of fingolimod on cognitive performance in patients with relapsing-remitting multiple sclerosis.,"BACKGROUND AND PURPOSE


Studies reporting the baseline determinants of cognitive performance and treatment effect on cognition in patients with multiple sclerosis (MS) are limited. We investigated the baseline correlates of cognition and the long-term treatment effects of fingolimod 0.5 mg once daily on cognitive processing speed and attention in patients with relapsing-remitting MS.
METHODS


This post hoc analysis pooled data from the phase 3 FREEDOMS and FREEDOMS II trials (N = 1556). We assessed the correlation between baseline patient demographic and disease characteristics and baseline 3-second Paced Auditory Serial Addition Test (PASAT-3) scores (Spearman's rank test) and the changes from baseline in PASAT-3 (mixed model repeated measures model) in the fingolimod and placebo (up to 24 months) or placebo-fingolimod switched (from Month 24 up to 120 months) groups. Additionally, the predictive value of PASAT-3 score for future disease outcomes was assessed (Cox or logistic regression models).
RESULTS


Among the variables assessed, lower PASAT-3 score at baseline correlated with higher disease burden (total brain volume, T2 lesion volume, and Expanded Disability Status Scale score), longer disease duration and older age (p < 0.0001 for all). Fingolimod significantly improved PASAT-3 scores from baseline versus placebo at 6 (1.3; p = 0.0007), 12 (1.1; p = 0.0044) and 24 months (1.1; p = 0.0028), with a sustained effect (overall treatment effect p = 0.0012) up to 120 months. Improvements were seen regardless of baseline cognitive status (PASAT quartile). Baseline PASAT-3 score was predictive of both clinical and magnetic resonance imaging measures of disease activity at Month 24 (p < 0.001 for all).
CONCLUSION


Early fingolimod treatment may offer long-term cognitive benefit in patients with relapsing-remitting MS.",2021,Fingolimod significantly improved PASAT-3 scores from baseline versus placebo at 6 (1.3;,"['patients with RRMS', 'patients with relapsing-remitting MS (RRMS', 'patients with relapsing-remitting multiple sclerosis', 'patients with MS']","['placebo', 'placebo-fingolimod', 'fingolimod', 'fingolimod and placebo']","['cognitive processing speed (CPS) and attention', 'cognitive performance', 'disease burden (total brain volume, T2 lesion volume, and Expanded Disability Status Scale score), longer disease duration and older age', 'clinical and MRI measures of disease activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.303692,Fingolimod significantly improved PASAT-3 scores from baseline versus placebo at 6 (1.3;,"[{'ForeName': 'Dawn W', 'Initials': 'DW', 'LastName': 'Langdon', 'Affiliation': 'Department of Psychology, Royal Holloway, University of London, Egham, UK.'}, {'ForeName': 'Davorka', 'Initials': 'D', 'LastName': 'Tomic', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Iris-Katharina', 'Initials': 'IK', 'LastName': 'Penner', 'Affiliation': 'Medical Faculty, Department of Neurology, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Calabrese', 'Affiliation': 'Neuropsychology and Behavioral Neurology Unit, Division of Cognitive and Molecular Neuroscience, University of Basel, Switzerland.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Dieter A', 'Initials': 'DA', 'LastName': 'Häring', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Dahlke', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) and MS Center, Neurology, Departments of Head, Spine and Neuromedicine and Clinical Research, University Hospital and University of Basel, Spitalstrasse 2, Basel, Schweiz, 4031, Switzerland.'}]",European journal of neurology,['10.1111/ene.15081']
3276,34428179,Randomized controlled trial of fractionated laser resurfacing on aged skin as prophylaxis against actinic neoplasia.,"BACKGROUNDThe loss of insulin-like growth factor 1 (IGF-1) expression in senescent dermal fibroblasts during aging is associated with an increased risk of nonmelanoma skin cancer (NMSC). We tested how IGF-1 signaling can influence photocarcinogenesis during chronic UVB exposure to determine if fractionated laser resurfacing (FLR) of aged skin, which upregulates dermal IGF-1 levels, can prevent the occurrence of actinic keratosis (AK) and NMSC.METHODSA human skin/immunodeficient mouse xenografting model was used to test the effects of a small molecule inhibitor of the IGF-1 receptor on chronic UVB radiation. Subsequently, the durability of FLR treatment was tested on a cohort of human participants aged 65 years and older. Finally, 48 individuals aged 60 years and older with considerable actinic damage were enrolled in a prospective randomized clinical trial in which they underwent a single unilateral FLR treatment of one lower arm. Numbers of AKs/NMSCs were recorded on both extremities for up to 36 months in blinded fashion.RESULTSXenografting studies revealed that chronic UVB treatment with a topical IGF-1R inhibitor resulted in a procarcinogenic response. A single FLR treatment was durable in restoring appropriate UVB response in geriatric skin for at least 2 years. FLR resulted in sustained reduction in numbers of AKs and decreased numbers of NMSCs in the treated arm (2 NMSCs) versus the untreated arm (24 NMSCs).CONCLUSIONThe elimination of senescent fibroblasts via FLR reduced the procarcinogenic UVB response of aged skin. Thus, wounding therapies are a potentially effective prophylaxis for managing high-risk populations.TRIAL REGISTRATIONClinicalTrials.gov (NCT03906253).FUNDINGNational Institutes of Health, Veterans Administration.",2021,"FLR resulted in sustained reduction in numbers of AKs and decreased numbers of NMSC in the treated (24) versus untreated (2) arms.
","['human subjects aged ≥65', '48 subjects aged 60 and older with considerable actinic damage', 'aged skin as prophylaxis against actinic neoplasia', 'A human skin/immunodeficient mouse xenografting model']","['FLR', 'fractionated laser resurfacing (FLR', 'fractionated laser resurfacing']","['Numbers of AKs/NMSCs', 'restoring appropriate UVB response', 'numbers of NMSC']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0037271', 'cui_str': 'Skin aging'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C3859811', 'cui_str': 'human skin preparation'}, {'cui': 'C0021051', 'cui_str': 'Immunodeficiency disorder'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0699893', 'cui_str': 'Skin carcinoma'}]",48.0,0.105995,"FLR resulted in sustained reduction in numbers of AKs and decreased numbers of NMSC in the treated (24) versus untreated (2) arms.
","[{'ForeName': 'Dan F', 'Initials': 'DF', 'LastName': 'Spandau', 'Affiliation': 'Department of Biochemistry and Molecular Biology and.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacology & Toxicology and.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Wargo', 'Affiliation': 'Department of Dermatology, Boonshoft School of Medicine at Wright State University, Dayton, Ohio, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Rohan', 'Affiliation': 'Department of Pharmacology & Toxicology and.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Southern', 'Affiliation': 'Department of Dermatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Loesch', 'Affiliation': 'Department of Dermatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weyerbacher', 'Affiliation': 'Department of Dermatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Tholpady', 'Affiliation': 'Richard L. Roudebush Veterans Administration Medical Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Davina A', 'Initials': 'DA', 'LastName': 'Lewis', 'Affiliation': 'Department of Dermatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kuhar', 'Affiliation': 'Department of Dermatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Kenneth Y', 'Initials': 'KY', 'LastName': 'Tsai', 'Affiliation': 'Departments of Anatomic Pathology and Tumor Biology, Moffit Cancer Center, Tampa, Florida, USA.'}, {'ForeName': 'Amber J', 'Initials': 'AJ', 'LastName': 'Castellanos', 'Affiliation': 'Department of Pharmacology & Toxicology and.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Kemp', 'Affiliation': 'Department of Pharmacology & Toxicology and.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Markey', 'Affiliation': 'Department of Dermatology, Boonshoft School of Medicine at Wright State University, Dayton, Ohio, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cates', 'Affiliation': 'Department of Pharmacology & Toxicology and.'}, {'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Williams', 'Affiliation': 'Department of Pharmacology & Toxicology and.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Knisely', 'Affiliation': 'Department of Pharmacology & Toxicology and.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Bashir', 'Affiliation': 'Department of Pharmacology & Toxicology and.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Gabbard', 'Affiliation': 'Department of Pharmacology & Toxicology and.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hoopes', 'Affiliation': 'Department of Pharmacology & Toxicology and.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Travers', 'Affiliation': 'Department of Pharmacology & Toxicology and.'}]",The Journal of clinical investigation,['10.1172/JCI150972']
3277,34419134,Physiological stress in safer cycling in older age (SiFAr-stress): effect of a multicomponent exercise intervention-a study protocol for a randomized controlled trial.,"BACKGROUND


SiFAr-Stress investigates the impact of cycling on stress levels in older adults. Uncertainty due to change to motorized bicycle or fear of falling can be perceived as stressors for cyclists. Stress activates different physiological signal cascades and stimulates the hypothalamic-pituitary-adrenal (HPA) axis, which leads to the release of the stress hormone cortisol and further effects such as the development of low-grade inflammation. Both can-in the long term-be associated with negative health outcomes. The aim of the study SiFAr-Stress is to analyze inflammatory processes as well as the activity of stress systems before and after a cycling intervention for older adults.
METHODS


In this study, community-dwelling older adults aged 65 years and older will be randomly assigned to either a cycling or a control intervention in a parallel-group design. Objective HPA axis-related measures (saliva cortisol and hair cortisol) will be assessed before, after, and 6-9 months after the cycling and control intervention (T0, T1, and T2). Furthermore, changes in cortisol reactivity in response to the cycling intervention will be investigated at the second and seventh training lessons. Furthermore, secondary outcomes (fear of falling, perceived stress, salivary alpha amylase, and C-reactive protein) will be assessed at T0, T1, and T2.
DISCUSSION


The study will be the first, in which stress- and health-related bio-physiological outcomes will be assessed in the context of a multicomponent exercise intervention, addressing cycling in older adults. It will enable us to better understand the underlying patho-physiological and psychological mechanisms and will help to improve interventions for this target group.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04362514 . Prospectively registered on 27 April 2020.",2021,"Furthermore, secondary outcomes (fear of falling, perceived stress, salivary alpha amylase, and C-reactive protein) will be assessed at T0, T1, and T2.
","['Prospectively registered on 27 April 2020', 'community-dwelling older adults aged 65\u2009years and older', 'older adults', 'older age (SiFAr-stress']","['multicomponent exercise intervention', 'control intervention']","['secondary outcomes (fear of falling, perceived stress, salivary alpha amylase, and C-reactive protein', 'cortisol reactivity', 'Objective HPA axis-related measures (saliva cortisol and hair cortisol']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}]",,0.0858775,"Furthermore, secondary outcomes (fear of falling, perceived stress, salivary alpha amylase, and C-reactive protein) will be assessed at T0, T1, and T2.
","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Britting', 'Affiliation': 'Institute for Biomedicine of Aging, Friedrich-Alexander-Universität Erlangen-Nürnberg, Kobergerstraße 60, 90408, Nuremberg, Bavaria, Germany. sabine.britting@fau.de.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kob', 'Affiliation': 'Institute for Biomedicine of Aging, Friedrich-Alexander-Universität Erlangen-Nürnberg, Kobergerstraße 60, 90408, Nuremberg, Bavaria, Germany.'}, {'ForeName': 'Cornel Christian', 'Initials': 'CC', 'LastName': 'Sieber', 'Affiliation': 'Institute for Biomedicine of Aging, Friedrich-Alexander-Universität Erlangen-Nürnberg, Kobergerstraße 60, 90408, Nuremberg, Bavaria, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rohleder', 'Affiliation': 'Department of Psychology, Chair of Health Psychology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Bavaria, Germany.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Freiberger', 'Affiliation': 'Institute for Biomedicine of Aging, Friedrich-Alexander-Universität Erlangen-Nürnberg, Kobergerstraße 60, 90408, Nuremberg, Bavaria, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Becker', 'Affiliation': 'Department of Psychology, Chair of Health Psychology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Bavaria, Germany.'}]",Trials,['10.1186/s13063-021-05481-5']
3278,34424730,Annual Tuberculosis Preventive Therapy for Persons With HIV Infection : A Randomized Trial.,"BACKGROUND


Tuberculosis preventive therapy for persons with HIV infection is effective, but its durability is uncertain.
OBJECTIVE


To compare treatment completion rates of weekly isoniazid-rifapentine for 3 months versus daily isoniazid for 6 months as well as the effectiveness of the 3-month rifapentine-isoniazid regimen given annually for 2 years versus once.
DESIGN


Randomized trial. (ClinicalTrials.gov: NCT02980016).
SETTING


South Africa, Ethiopia, and Mozambique.
PARTICIPANTS


Persons with HIV infection who were receiving antiretroviral therapy, were aged 2 years or older, and did not have active tuberculosis.
INTERVENTION


Participants were randomly assigned to receive weekly rifapentine-isoniazid for 3 months, given either annually for 2 years or once, or daily isoniazid for 6 months. Participants were screened for tuberculosis symptoms at months 0 to 3 and 12 of each study year and at months 12 and 24 using chest radiography and sputum culture.
MEASUREMENTS


Treatment completion was assessed using pill counts. Tuberculosis incidence was measured over 24 months.
RESULTS


Between November 2016 and November 2017, 4027 participants were enrolled; 4014 were included in the analyses (median age, 41 years; 69.5% women; all using antiretroviral therapy). Treatment completion in the first year for the combined rifapentine-isoniazid groups ( n  = 3610) was 90.4% versus 50.5% for the isoniazid group ( n  = 404) (risk ratio, 1.78 [95% CI, 1.61 to 1.95]). Tuberculosis incidence among participants receiving the rifapentine-isoniazid regimen twice ( n  = 1808) or once ( n  = 1802) was similar (hazard ratio, 0.96 [CI, 0.61 to 1.50]).
LIMITATION


If rifapentine-isoniazid is effective in curing subclinical tuberculosis, then the intensive tuberculosis screening at month 12 may have reduced its effectiveness.
CONCLUSION


Treatment completion was higher with rifapentine-isoniazid for 3 months compared with isoniazid for 6 months. In settings with high tuberculosis transmission, a second round of preventive therapy did not provide additional benefit to persons receiving antiretroviral therapy.
PRIMARY FUNDING SOURCE


The U.S. Agency for International Development through the CHALLENGE TB grant to the KNCV Tuberculosis Foundation.",2021,"In settings with high tuberculosis transmission, a second round of preventive therapy did not provide additional benefit to persons receiving antiretroviral therapy.
","['Persons with HIV infection who were receiving antiretroviral therapy, were aged 2 years or older, and did not have active tuberculosis', 'persons with HIV infection', 'Persons With HIV Infection ', 'Participants were screened for tuberculosis symptoms at months 0 to 3 and 12 of each study year and at months 12 and 24 using chest radiography and sputum culture', '4027 participants were enrolled; 4014 were included in the analyses (median age, 41 years; 69.5% women; all using antiretroviral therapy', 'South Africa, Ethiopia, and Mozambique', 'Between November 2016 and November 2017']","['Annual Tuberculosis Preventive Therapy', 'isoniazid', 'isoniazid-rifapentine', 'rifapentine-isoniazid regimen', 'rifapentine-isoniazid']",['Tuberculosis incidence'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0740413', 'cui_str': 'Tuberculosis prophylaxis'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",4027.0,0.358187,"In settings with high tuberculosis transmission, a second round of preventive therapy did not provide additional benefit to persons receiving antiretroviral therapy.
","[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Churchyard', 'Affiliation': 'The Aurum Institute, Parktown, South Africa, Vanderbilt University, Nashville, Tennessee, and University of the Witwatersrand, Johannesburg, South Africa (G.C.).'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Cárdenas', 'Affiliation': 'The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).'}, {'ForeName': 'Violet', 'Initials': 'V', 'LastName': 'Chihota', 'Affiliation': 'The Aurum Institute, Parktown, South Africa, and University of the Witwatersrand, Johannesburg, South Africa (V.C., S.C.).'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Mngadi', 'Affiliation': 'The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).'}, {'ForeName': 'Modulakgotla', 'Initials': 'M', 'LastName': 'Sebe', 'Affiliation': 'The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brumskine', 'Affiliation': 'The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martinson', 'Affiliation': 'University of the Witwatersrand, Johannesburg, South Africa, and Amsterdam University Medical Centres, Amsterdam, the Netherlands (N.M.).'}, {'ForeName': 'Getnet', 'Initials': 'G', 'LastName': 'Yimer', 'Affiliation': 'The Ohio State University, Addis Ababa, Ethiopia (G.Y., S.W.).'}, {'ForeName': 'Shu-Hua', 'Initials': 'SH', 'LastName': 'Wang', 'Affiliation': 'The Ohio State University, Addis Ababa, Ethiopia (G.Y., S.W.).'}, {'ForeName': 'Alberto L', 'Initials': 'AL', 'LastName': 'Garcia-Basteiro', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique (A.L.G., D.N.).'}, {'ForeName': 'Dinis', 'Initials': 'D', 'LastName': 'Nguenha', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique (A.L.G., D.N.).'}, {'ForeName': 'LeeAnne', 'Initials': 'L', 'LastName': 'Masilela', 'Affiliation': 'The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Waggie', 'Affiliation': 'The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'van den Hof', 'Affiliation': 'KNCV Tuberculosis Foundation, Den Haag, the Netherlands, and National Institute for Public Health and the Environment, Bilthoven, the Netherlands (S.V.).'}, {'ForeName': 'Salome', 'Initials': 'S', 'LastName': 'Charalambous', 'Affiliation': 'The Aurum Institute, Parktown, South Africa, and University of the Witwatersrand, Johannesburg, South Africa (V.C., S.C.).'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cobelens', 'Affiliation': 'Amsterdam University Medical Centres, Amsterdam, the Netherlands (F.C.).'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Chaisson', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland (R.E.C.).'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Grant', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, United Kingdom, University of the Witwatersrand, Johannesburg, South Africa, and University of KwaZulu-Natal, Durban, South Africa (A.D.G.).'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Fielding', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, United Kingdom, and University of the Witwatersrand, Johannesburg, South Africa (K.L.F.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M20-7577']
3279,34425533,The impact of induction chemotherapy on long-term quality of life in patients with locoregionally advanced nasopharyngeal carcinoma: Outcomes from a randomised phase 3 trial.,"BACKGROUND


Our previous trial confirmed that induction chemotherapy (IC) improved long-term survival outcomes in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). In this study, we investigated the impact of IC on long-term quality of life (QoL) in this cohort.
METHODS


Our trial was a randomised, open-label phase 3 trial comparing IC followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in patients with stage III-IVB (except T3N0-1) NPC. All participants completed two self-administered questionnaires, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) and the EORTC QLQ Head and Neck Cancer-Specific Module (H&N35). As per protocol, the questionnaires had to be completed before knowledge of treatment allocation by the patient (baseline). Patients were then approached to enroll at the time of the present study period.
RESULTS


Ultimately, QoL data from 228 patients were included in the analysis. Most scales were both statistically and clinically decreased in both groups between baseline and the latest follow-up. The IC followed by CCRT group had significantly better outcome in role functioning, cognitive functioning, social functioning, fatigue, pain, and constipation in QLQ-C30 scales at the last follow-up. Similarly, in H&N35 scales, a significantly better result was observed in pain, sexuality, sticky saliva, pain killers use, nutritional supplements, and weight loss, but a poorer result in senses problems, for those treated by IC followed by CCRT.
CONCLUSION


IC followed by CCRT seemed to have better long-term QoL outcomes compared with CCRT alone in patients with locoregionally advanced NPC.",2021,"The IC followed by CCRT group had significantly better outcome in role functioning, cognitive functioning, social functioning, fatigue, pain, and constipation in QLQ-C30 scales at the last follow-up.","['228 patients were included in the analysis', 'patients with locoregionally advanced NPC', 'patients with locoregionally advanced nasopharyngeal carcinoma', 'patients with locoregionally advanced nasopharyngeal carcinoma (NPC', 'patients with stage III-IVB (except T3N0-1) NPC']","['CCRT', 'concurrent chemoradiotherapy (CCRT) versus CCRT', 'induction chemotherapy', 'induction chemotherapy (IC']","['European Organization for Research and Treatment of Cancer (EORTC', 'role functioning, cognitive functioning, social functioning, fatigue, pain, and constipation in QLQ-C30 scales', 'long-term quality of life (QoL', 'pain, sexuality, sticky saliva, pain killers use, nutritional supplements, and weight loss', 'Quality of Life Questionnaire C30 (QLQ-C30) and the EORTC QLQ Head and Neck Cancer-Specific Module']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}]","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3542953', 'cui_str': 'Module'}]",228.0,0.110239,"The IC followed by CCRT group had significantly better outcome in role functioning, cognitive functioning, social functioning, fatigue, pain, and constipation in QLQ-C30 scales at the last follow-up.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Meng-Xia', 'Initials': 'MX', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chong-Yang', 'Initials': 'CY', 'LastName': 'Duan', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'You-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yu-Long', 'Initials': 'YL', 'LastName': 'Xie', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'You', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yi-Jun', 'Initials': 'YJ', 'LastName': 'Hua', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Pei-Yu', 'Initials': 'PY', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ming-Huang', 'Initials': 'MH', 'LastName': 'Hong', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Clinical Trial Center, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: chenmy@sysucc.org.cn.'}, {'ForeName': 'Ming-Yuan', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Oral oncology,['10.1016/j.oraloncology.2021.105494']
3280,34425422,Impacts on patient-centered outcomes of a chronic pain self-management program in a rural community: A feasibility study.,"This study explored if a self-management training program was feasible for a predominantly older rural Latino adults with chronic pain who had limited access to non-pharmacologically based pain treatment. Physical therapy doctoral students delivered the six-week low-literacy low-cost patient-centered program. The intervention was feasible to the participants (n=38) who showed improvement in a majority of the eight outcome measures at 6-week posttest and three measures at 18-week followup. The changes in pain severity, pain interference and pain-related physical functions reached minimally clinically important difference at follow-up. A randomized controlled trial with long-term follow-up is needed to test the program effectiveness in partnership with community health centers to increase access to pain management in rural communities.",2021,"The changes in pain severity, pain interference and pain-related physical functions reached minimally clinically important difference at follow-up.","['partnership with community health centers', 'rural communities', 'a rural community', 'predominantly older rural Latino adults with chronic pain who had limited access to non-pharmacologically based pain treatment']","['Physical therapy doctoral students delivered the six-week low-literacy low-cost patient-centered program', 'self-management training program', 'chronic pain self-management program']","['pain severity, pain interference and pain-related physical functions']","[{'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",38.0,0.0192998,"The changes in pain severity, pain interference and pain-related physical functions reached minimally clinically important difference at follow-up.","[{'ForeName': 'Zenong', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Loretta J. Lowak Clarke Distinguished Professor in Health and Kinesiology, Department of Public Health, College of Health, Community and Policy (HCaP), The University of Texas at San Antonio, United States. Electronic address: Zenong.Yin@utsa.edu.'}, {'ForeName': 'Shiyu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'School of Nursing, UT Health San Antonio, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ortega', 'Affiliation': 'Loretta J. Lowak Clarke Distinguished Professor in Health and Kinesiology, Department of Public Health, College of Health, Community and Policy (HCaP), The University of Texas at San Antonio, United States.'}, {'ForeName': 'Raudel', 'Initials': 'R', 'LastName': 'Bobadilla', 'Affiliation': 'ReACH Center, UT Health San Antonio, United States.'}, {'ForeName': 'Paula L', 'Initials': 'PL', 'LastName': 'Winkler', 'Affiliation': 'South Central Area Health Education Center, UT Health San Antonio, United States.'}, {'ForeName': 'Arthur E', 'Initials': 'AE', 'LastName': 'Hernández', 'Affiliation': 'Dreeben School of Education, University of the Incarnate Word, United States.'}, {'ForeName': 'Maureen J', 'Initials': 'MJ', 'LastName': 'Simmonds', 'Affiliation': 'Loretta J. Lowak Clarke Distinguished Professor in Health and Kinesiology, Department of Public Health, College of Health, Community and Policy (HCaP), The University of Texas at San Antonio, United States.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.06.026']
3281,34431518,Early weight loss is an independent risk factor for shorter survival and increased side effects in patients with metastatic colorectal cancer undergoing first-line treatment within the randomized Phase III trial FIRE-3 (AIO KRK-0306).,"Body weight loss is frequently regarded as negatively related to outcomes in patients with malignancies. This retrospective analysis of the FIRE-3 study evaluated the evolution of body weight in patients with metastatic colorectal cancer (mCRC). FIRE-3 evaluated first-line FOLFIRI (folinic acid, fluorouracil and irinotecan) plus cetuximab or bevacizumab in mCRC patients with RAS-WT tumors (ie, wild-type in KRAS and NRAS exons 2-4). The prognostic and predictive relevance of early weight loss (EWL) regarding patient outcomes and treatment side effects were evaluated. Retrospective data on body weight during first 6 months of treatment were evaluated (N = 326). To correlate with efficacy endpoints and treatment side effects, patients were grouped according to clinically significant EWL ≥5% and <5% at Month 3. Age constituted the only significant predictor of EWL following a linear relationship with the corresponding log odds ratio (P = .016). EWL was significantly associated with the incident frequencies of diarrhea, edema, fatigue, nausea and vomiting. Further, a multivariate analysis revealed EWL to be an independent negative prognostic factor for overall survival (32.4 vs 21.1 months; hazard ratio [HR]: 1.64; 95% confidence interval [CI] = 1.13-2.38; P = .0098) and progression-free survival (11.8 vs 9.0 months; HR: 1.72; 95% CI = 1.18-2.5; P = .0048). In conclusion, EWL during systemic treatment against mCRC is significantly associated with patient age. Patients exhibiting EWL had worse survival and higher frequencies of adverse events. Early preventative measures targeted at weight maintenance should be evaluated, especially in elderly patients being at highest risk of EWL.",2022,Patients exhibiting EWL had worse survival and higher frequencies of adverse events.,"['elderly patients being at highest risk of EWL', 'patients with malignancies', 'mCRC patients with RAS-WT tumors', 'patients with metastatic colorectal cancer undergoing first-line treatment', 'patients with metastatic colorectal cancer (mCRC']","['FIRE-3 evaluated first line FOLFIRI (folinic acid, fluorouracil and irinotecan) plus cetuximab or bevacizumab']","['overall survival', 'Body weight loss', 'body weight', 'incident frequencies of diarrhoea, oedema, fatigue, nausea and vomiting', 'progression free survival', 'worse survival and higher frequencies of adverse events']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}]","[{'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0352893,Patients exhibiting EWL had worse survival and higher frequencies of adverse events.,"[{'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Nicole Tonya', 'Initials': 'NT', 'LastName': 'Erickson', 'Affiliation': 'Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ricard', 'Affiliation': 'Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Ludwig Fischer', 'Initials': 'LF', 'LastName': 'von Weikersthal', 'Affiliation': 'Gesundheitszentrum St Marien, Amberg, Germany.'}, {'ForeName': 'Markus M', 'Initials': 'MM', 'LastName': 'Lerch', 'Affiliation': 'Klinik und Poliklinik für Innere Medizin A, Universitätsmedizin Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Studienzentrum Onkologie Ravensburg, Ravensburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kiani', 'Affiliation': 'Klinikum Bayreuth GmbH, Bayreuth, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Praxis Hämatologie/Onkologie/Palliativmedizin-Tagesklinik, Landshut, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Heintges', 'Affiliation': 'Lukaskrankenhaus Neuss, Neuss, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kahl', 'Affiliation': 'Städtisches Klinikum Magdeburg, Hämatologie/ Onkologie, Magdeburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kullmann', 'Affiliation': 'Klinikum Weiden, Medizinische Klinik I, Weiden, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Internal Medicine I and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': 'Department of Medicine I, Westpfalz-Klinikum GmbH, Kaiserslautern, Germany.'}, {'ForeName': 'Heinz-Gert', 'Initials': 'HG', 'LastName': 'Höffkes', 'Affiliation': 'Klinikum Fulda, Tumorklinik, Fulda, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Medical Department 1, Johannes-Gutenberg Universität Mainz, Mainz, Germany.'}, {'ForeName': 'Alena Britta', 'Initials': 'AB', 'LastName': 'Gesenhues', 'Affiliation': 'Department of Radiology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Theurich', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Michl', 'Affiliation': 'Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Algül', 'Affiliation': 'Comprehensive Cancer Center Munich TUM, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'German Cancer Consortium (DKTK), Partner Site Munich and German Cancer Research Centre (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Julian W', 'Initials': 'JW', 'LastName': 'Holch', 'Affiliation': 'Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.'}]",International journal of cancer,['10.1002/ijc.33775']
3282,34428506,Three-year hand hygiene monitoring and impact of real-time reminders on compliance.,"BACKGROUND


Hand hygiene remains both the major strategy and an ongoing challenge for infection control. The main issues in the sustainability of hand hygiene automatic monitoring are healthcare worker (HCW) turnover rates and declining participation.
AIM


To assess hand hygiene compliance and the impact of real-time reminders over three years.
METHODS


HCW compliance was observed for the use of alcohol-based hand rubs (AHR) on room entry and exit. Linear multi-level mixed models with time autocorrelations were performed to analyse the repeated measurements of daily room compliance and the effect of reminders over eight quarters (24 months).
FINDINGS


In all, 111 HCWs were observed and 525,576 activities were identified in the database. There was an improvement in compliance both on room entry and exit over two years, and the rooms which had activated reminders had better performance than the rooms which did not have activated reminders.
CONCLUSIONS


This study showed the benefit of using real-time reminders; even 20% of rooms with an activated reminder improved overall hand hygiene compliance. A randomized real-time reminder setting may be a potential solution in reducing user fatigue and enhancing HCW self-awareness.",2021,We observed HCWs and room compliance with using alcohol-based hand rubs (AHR) on room entry and exit.,[],['alcohol-based hand rubs (AHR'],"['overall hand hygiene compliance', '525,576 activities']",[],"[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",111.0,0.020569,We observed HCWs and room compliance with using alcohol-based hand rubs (AHR) on room entry and exit.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Aix Marseille Université, IRD, MEPHI, IHU-Méditerranée Infection, Marseille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boudjema', 'Affiliation': 'Aix Marseille Université, IRD, MEPHI, IHU-Méditerranée Infection, Marseille, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Brouqui', 'Affiliation': 'Aix Marseille Université, IRD, MEPHI, IHU-Méditerranée Infection, Marseille, France; AP-HM, IHU-Méditerranée Infection, Marseille, France. Electronic address: philippe.brouqui@univ-amu.fr.'}]",The Journal of hospital infection,['10.1016/j.jhin.2021.08.015']
3283,34433695,"Paclitaxel Drug-Coated Balloon for the Treatment of De Novo Small-Vessel and Restenotic Coronary Artery Lesions: 12-Month Results of the Prospective, Multicenter, Single-Arm PREVAIL Study.","OBJECTIVES


The PREVAIL study evaluated the safety and effectiveness of a paclitaxel-coated percutaneous transluminal coronary angioplasty balloon catheter for the treatment of coronary de novo and in-stent restenosis (ISR) lesions in patients with symptomatic ischemic heart disease.
METHODS


PREVAIL was a prospective, multicenter, single-arm study that enrolled patients with clinical evidence of ischemia who had coronary lesions (de novo or first ISR) amenable to treatment with a drug-coated balloon (DCB). The study included 50 subjects (53 target lesions) who were treated with a Prevail DCB (Medtronic) during the index procedure and followed for 12 months. Mean lesion length was 14.5 ± 7.6 mm. The primary endpoint was in-stent (in-balloon) late lumen loss (LLL) by quantitative coronary angiography at 6 months post procedure. If the mean in-stent (in-balloon) LLL was less than the maximum acceptance rate of 0.50 mm at 6 months, then the study was considered successful.
RESULTS


Mean in-stent (in-balloon) LLL was 0.05 ± 0.44 mm at 6 months post procedure. There were no deaths, myocardial infarctions, or stent (lesion) thrombosis events within 12 months. The incidence of clinically driven target-lesion revascularization was 6.0% at 12 months and clinically driven target-vessel revascularization was 10.0%.
CONCLUSIONS


Paclitaxel DCB treatment of coronary de novo and first ISR lesions led to low LLL at 6 months and low rates of revascularization and safety events through 12 months.",2021,"There were no deaths, myocardial infarctions, or stent (lesion) thrombosis events within 12 months.","['50 subjects (53 target lesions) who were treated with a Prevail DCB (Medtronic) during the index procedure and followed for 12 months', 'De Novo Small-Vessel and Restenotic Coronary Artery Lesions', 'enrolled patients with clinical evidence of ischemia who had coronary lesions (de novo or first ISR) amenable to treatment with a drug-coated balloon (DCB', 'patients with symptomatic ischemic heart disease']","['paclitaxel-coated percutaneous transluminal coronary angioplasty balloon catheter', 'Paclitaxel Drug-Coated Balloon', 'Paclitaxel DCB']","['safety and effectiveness', 'incidence of clinically driven target-lesion revascularization', 'deaths, myocardial infarctions, or stent (lesion) thrombosis events', 'stent (in-balloon) late lumen loss (LLL', 'Mean lesion length']","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3152857', 'cui_str': 'Prevail'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C3873932', 'cui_str': 'Coronary angioplasty balloon catheter'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",50.0,0.0215741,"There were no deaths, myocardial infarctions, or stent (lesion) thrombosis events within 12 months.","[{'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Latib', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, 111 East 210th Street, Bronx, NY 10467 USA. alatib@gmail.com.'}, {'ForeName': 'Pierfrancesco', 'Initials': 'P', 'LastName': 'Agostoni', 'Affiliation': ''}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Dens', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Patterson', 'Affiliation': ''}, {'ForeName': 'Patrizio', 'Initials': 'P', 'LastName': 'Lancellotti', 'Affiliation': ''}, {'ForeName': 'Frankie C C', 'Initials': 'FCC', 'LastName': 'Tam', 'Affiliation': ''}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Schotborgh', 'Affiliation': ''}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': ''}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Stella', 'Affiliation': ''}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Gwenn', 'Initials': 'G', 'LastName': 'Wetzels', 'Affiliation': ''}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Testa', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of invasive cardiology,[]
3284,34407342,Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma.,"BACKGROUND


Patients with renal-cell carcinoma who undergo nephrectomy have no options for adjuvant therapy to reduce the risk of recurrence that have high levels of supporting evidence.
METHODS


In a double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with clear-cell renal-cell carcinoma who were at high risk for recurrence after nephrectomy, with or without metastasectomy, to receive either adjuvant pembrolizumab (at a dose of 200 mg) or placebo intravenously once every 3 weeks for up to 17 cycles (approximately 1 year). The primary end point was disease-free survival according to the investigator's assessment. Overall survival was a key secondary end point. Safety was a secondary end point.
RESULTS


A total of 496 patients were randomly assigned to receive pembrolizumab, and 498 to receive placebo. At the prespecified interim analysis, the median time from randomization to the data-cutoff date was 24.1 months. Pembrolizumab therapy was associated with significantly longer disease-free survival than placebo (disease-free survival at 24 months, 77.3% vs. 68.1%; hazard ratio for recurrence or death, 0.68; 95% confidence interval [CI], 0.53 to 0.87; P = 0.002 [two-sided]). The estimated percentage of patients who remained alive at 24 months was 96.6% in the pembrolizumab group and 93.5% in the placebo group (hazard ratio for death, 0.54; 95% CI, 0.30 to 0.96). Grade 3 or higher adverse events of any cause occurred in 32.4% of the patients who received pembrolizumab and in 17.7% of those who received placebo. No deaths related to pembrolizumab therapy occurred.
CONCLUSIONS


Pembrolizumab treatment led to a significant improvement in disease-free survival as compared with placebo after surgery among patients with kidney cancer who were at high risk for recurrence. (Funded by Merck Sharp and Dohme, a subsidiary of Merck; KEYNOTE-564 ClinicalTrials.gov number, NCT03142334.).",2021,"Pembrolizumab therapy was associated with significantly longer disease-free survival than placebo (disease-free survival at 24 months, 77.3% vs. 68.1%; hazard ratio for recurrence or death, 0.68; 95% confidence interval [CI], 0.53 to 0.87; P = 0.002 [two-sided]).","['A total of 496 patients', 'patients with kidney cancer', 'patients with clear-cell renal-cell carcinoma who were at high risk for recurrence after nephrectomy, with or without metastasectomy, to receive either', 'Patients with renal-cell carcinoma who undergo', 'Renal-Cell Carcinoma']","['nephrectomy', 'pembrolizumab', 'Pembrolizumab therapy', 'Adjuvant Pembrolizumab', 'Pembrolizumab', 'placebo', 'adjuvant pembrolizumab']","['longer disease-free survival', 'Grade 3 or higher adverse events', 'Overall survival', 'disease-free survival']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",496.0,0.849775,"Pembrolizumab therapy was associated with significantly longer disease-free survival than placebo (disease-free survival at 24 months, 77.3% vs. 68.1%; hazard ratio for recurrence or death, 0.68; 95% confidence interval [CI], 0.53 to 0.87; P = 0.002 [two-sided]).","[{'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Tomczak', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Balaji', 'Initials': 'B', 'LastName': 'Venugopal', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ferguson', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Yen-Hwa', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Hajek', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Stefan N', 'Initials': 'SN', 'LastName': 'Symeonides', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sarwar', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Gross-Goupil', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Mahave', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Naomi B', 'Initials': 'NB', 'LastName': 'Haas', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Sawrycki', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chevreau', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Evgeniy', 'Initials': 'E', 'LastName': 'Kopyltsov', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Ajjai', 'Initials': 'A', 'LastName': 'Alva', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Burke', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Gurjyot', 'Initials': 'G', 'LastName': 'Doshi', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Topart', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Hammers', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kitamura', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bedke', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Rodolfo F', 'Initials': 'RF', 'LastName': 'Perini', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Pingye', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Imai', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Jaqueline', 'Initials': 'J', 'LastName': 'Willemann-Rogerio', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'From Dana-Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) - both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.) and the Royal Free Hospital NHS Trust, University College London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Macquarie University, Sydney (H.G.) - both in Australia; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Fakultni Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - both in the Czech Republic; University Hospital Jean Minjoz, Besançon (A.T.-V.), University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse (C.C.), Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.), and Hôpital Européen Georges Pompidou, University of Paris, Paris (S.O.) - all in France; Fundación Arturo López Pérez, Santiago, Chile (M.M.); Abramson Cancer Center, Philadelphia (N.H.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); Rocky Mountain Cancer Centers and U.S. Oncology Research, Denver (J.M.B.); Texas Oncology, U.S. Oncology Research, Woodlands (G.D.), and the University of Texas Southwestern, Dallas (H.H.); the University of Toyama, Toyama, Japan (H.K.); Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); Merck, Kenilworth, NJ (R.F.P., P.Z., K.I., J.W.-R.); and USC Norris Comprehensive Cancer Center, Los Angeles (D.I.Q.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2106391']
3285,28332137,Correction of dilutional anemia induces renal dysfunction in diabetic patients undergoing coronary artery bypass grafting: a consequence of microcirculatory alterations?,"BACKGROUND


In this study we aimed to evaluate the effects of dilutional anemia resulting from cardiopulmonary bypass (CPB) and its correction with red blood cell (RBC) transfusion on tissue oxygenation and renal function in diabetic patients undergoing coronary artery bypass grafting (CABG).
METHOD


70 diabetic patients who underwent elective CABG and whose hematocrit values had been between 24-28% at any time during CBP were prospectively randomized and equally allocated to two groups: patients who received RBC during CPB (group I, n = 35) vs. did not receive RBC during CPB (group II, n = 35). Besides routine hemodynamic and biochemical parameters, biomarkers of ischemia and renal injury such as ischemia modified albumin (IMA), protein oxidation parameters [advanced oxidative protein products (AOPP), total thiol (T-SH)], neutrophil gelatinase-associated lipocalin (NGAL) and estimated glomerular filtration rate (eGFR) were measured in both groups.
RESULTS


In group I, T-SH, NGAL and urea levels were found to be significantly increased postoperatively compared to preoperative measurements (p < 0.05). Also, postoperatively, NGAL, creatinine, aspartate aminotransferase and AOPP levels were higher in group I than group II (p < 0.05).
CONCLUSION


The correction of anemia with RBC transfusion in diabetic patients undergoing CABG could increase the risk of renal injury. Further studies verifying the effects of blood transfusions at the microcirculatory level are needed to optimize the efficacy of transfusions.",2018,"In group I, T-SH, NGAL and urea levels were found to be significantly increased postoperatively compared to preoperative measurements (p < 0.05).","['diabetic patients undergoing', 'diabetic patients undergoing coronary artery bypass grafting (CABG', '70 diabetic patients who underwent elective CABG and whose hematocrit values had been between 24-28% at any time during CBP']","['cardiopulmonary bypass (CPB) and its correction with red blood cell (RBC) transfusion', 'coronary artery bypass grafting', 'CABG', 'RBC during CPB']","['T-SH, NGAL and urea levels', 'postoperatively, NGAL, creatinine, aspartate aminotransferase and AOPP levels', 'risk of renal injury', 'ischemia and renal injury such as ischemia modified albumin (IMA), protein oxidation parameters [advanced oxidative protein products (AOPP), total thiol (T-SH)], neutrophil gelatinase-associated lipocalin (NGAL) and estimated glomerular filtration rate (eGFR']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0301039', 'cui_str': '1-Chloro-3-bromopropene-1 (substance)'}]","[{'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}]","[{'cui': 'C0428275', 'cui_str': 'Urea level - finding'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C1976991', 'cui_str': 'AOPPs'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney (disorder)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C3266190', 'cui_str': 'ischemia-modified serum albumin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038734', 'cui_str': 'Mercaptans'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C3811844'}]",70.0,0.0131345,"In group I, T-SH, NGAL and urea levels were found to be significantly increased postoperatively compared to preoperative measurements (p < 0.05).","[{'ForeName': 'Güçlü', 'Initials': 'G', 'LastName': 'Aykut', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Kilercik', 'Affiliation': 'Department of Biochemistry, School of Medicine, Acıbadem University, Istanbul, Turkey.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Arıtürk', 'Affiliation': 'Department of Cardiovascular Surgery, School of Medicine, Acıbadem University, Istanbul, Turkey.'}, {'ForeName': 'Halim', 'Initials': 'H', 'LastName': 'Ulugöl', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Acibadem Kadiköy Hospital, Acıbadem University, Tekin sok. No: 8, 34713 Kadiköy, Istanbul, Turkey.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Aksu', 'Affiliation': 'Department of Biology, Faculty of Science, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Türkan', 'Initials': 'T', 'LastName': 'Kudsioğlu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Dr Siyami Ersek Thoracic and Cardiovascular Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Atalan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Dr Siyami Ersek Thoracic and Cardiovascular Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nihan', 'Initials': 'N', 'LastName': 'Yapıcı', 'Affiliation': 'Department of Anesthesiology and Reanimation, Dr Siyami Ersek Thoracic and Cardiovascular Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Karabulut', 'Affiliation': 'Department of Cardiovascular Surgery, School of Medicine, Acıbadem University, Istanbul, Turkey.'}, {'ForeName': 'Fevzi', 'Initials': 'F', 'LastName': 'Toraman', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Acibadem Kadiköy Hospital, Acıbadem University, Tekin sok. No: 8, 34713 Kadiköy, Istanbul, Turkey. ftoraman@gmail.com.'}]",Journal of nephrology,['10.1007/s40620-017-0388-8']
3286,31930360,Effectiveness of Combined Behavioral and Drug Therapy for Overactive Bladder Symptoms in Men: A Randomized Clinical Trial.,"Importance


First-line behavioral and drug therapies for overactive bladder (OAB) symptoms in men are effective but not usually curative.
Objective


To determine whether combining behavioral and drug therapies improves outcomes compared with each therapy alone for OAB in men and to compare 3 sequences for implementing combined therapy.
Design, Setting, and Participants


In this 3-site, 2-stage, 3-arm randomized clinical trial, participants were randomized to 6 weeks of behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy for all groups. Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours. Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019.
Interventions


Behavioral therapy consisted of pelvic floor muscle training with urge suppression strategies and delayed voiding. Drug therapy included an antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg).
Main Outcomes and Measures


Seven-day bladder diaries completed before and after each 6-week treatment stage were used to calculate reduction in frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia). Other secondary outcomes included validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score.
Results


Of the 204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years. A total of 21 men discontinued treatment and 183 completed treatment. Mean (SD) voids per 24 hours decreased significantly in all 3 groups from baseline to 6-week follow-up (behavioral therapy: 11.7 [2.4] vs 8.8 [2.1]; change, 2.9 [2.4]; percentage change, 24.7%; P < .001; drug therapy: 11.8 [2.5] vs 10.3 [2.7]; change, 1.5 [2.3]; percentage change, 12.7%; P < .001; combined therapy: 11.8 [2.4] vs 8.2 [2.3]; change, 3.6 [2.1]; percentage change, 30.5%; P < .001). Intention-to-treat analyses indicated that posttreatment mean (SD) voiding frequencies were significantly lower in those receiving combined therapy compared with drug therapy alone (8.2 [2.3] vs 10.3 [2.7]; P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001). At 12-week follow-up, after all groups had received combined therapy, improvements in mean (SD) voids per 24 hours were also greatest for those receiving initial combined therapy compared with baseline (behavioral therapy: 11.7 [2.4] vs 8.0 [2.2]; change, 3.7 [2.3]; percentage change, 31.6%; P < .001; drug therapy: 11.8 [2.5] vs 8.6 [2.3]; change, 3.2 [2.5]; percentage change, 27.1%; P < .001; combined therapy: 11.8 [2.4] vs 8.0 [2.2]; change, 3.8 [2.1]; percentage change, 32.2%; P < .001), but there were no statistically significant group differences on primary or secondary measures.
Conclusions and Relevance


Combining behavioral and drug therapy yields greater improvements in OAB symptoms than drug therapy alone but not behavioral therapy alone. When using a stepped approach, it is reasonable to begin with behavioral therapy alone.
Trial Registration


ClinicalTrials.gov identifier: NCT01175382.",2020,P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001).,"['204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years', 'Overactive Bladder Symptoms in Men', 'Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019', 'Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours', '21 men discontinued treatment and 183 completed treatment']","['antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg', 'behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy', 'Combined Behavioral and Drug Therapy', 'pelvic floor muscle training with urge suppression strategies and delayed voiding']","['Mean (SD) voids per 24 hours', 'mean (SD) voids', 'frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia', 'OAB symptoms', 'validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score', 'posttreatment mean (SD) voiding frequencies', 'Main Outcomes and Measures\n\n\nSeven-day bladder diaries', 'overactive bladder (OAB) symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0456696', 'cui_str': '/24h'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456696', 'cui_str': '/24h'}, {'cui': 'C2584336', 'cui_str': 'Frequency of urination (observable entity)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}]",,0.0524237,P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Kraus', 'Affiliation': 'Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio.'}, {'ForeName': 'Theodore M', 'Initials': 'TM', 'LastName': 'Johnson', 'Affiliation': 'Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, Georgia.'}, {'ForeName': 'Alayne D', 'Initials': 'AD', 'LastName': 'Markland', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Camille P', 'Initials': 'CP', 'LastName': 'Vaughan', 'Affiliation': 'Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, Georgia.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Redden', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Goode', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.6398']
3287,32078379,Parent-Child Interaction Therapy with Toddlers: A Community-based Randomized Controlled Trial with Children Aged 14-24 Months.,"Objective : Children with early-onset behavioral issues are at high risk for ongoing behavioral, psychological, and social issues. Method : This study examined the efficacy of the first phase of Parent-Child Interaction Therapy with Toddlers, Child-Directed Interaction - Toddler, using a randomized control design. Sixty-six mother-toddler dyads (Child  M age = 19.13 months; 63% male; 34% from a non-English speaking background) referred to a community-based child behavior clinic in Australia received CDI-T immediately or were assigned to a waitlist control condition. At baseline (Time 1) and post-treatment/post-waitlist (Time 2), mothers completed questionnaires (Child Behavior Checklist, Edinburgh Postnatal Depression Scale, Parenting Stress Index - Short Form) and participated in a structured parent-child dyadic play-based interaction later coded using the Dyadic Parent-Child Interaction Coding System and the Emotional Availability Scales. Results : Compared to those who did not receive treatment, mother-child dyads who received the intervention showed significantly better parenting skills (increases in positive parenting skills and decreases in negative parenting skills), emotional availability (increases in parental sensitivity and parental non-intrusiveness), child behavior (decreases in externalizing and internalizing behaviors) and parental perceptions of child difficulty. Conclusions : Results suggest that the CDI-T phase of PCIT-T is a promising intervention for toddlers presenting with behavioral issues. Future studies should be conducted to assess efficacy in other settings and to assess longer-term outcomes.",2021,"Compared to those who did not receive treatment, mother-child dyads who received the intervention showed significantly better parenting skills (increases in positive parenting skills and decreases in negative parenting skills), emotional availability (increases in parental sensitivity and parental non-intrusiveness), child behavior (decreases in externalizing and internalizing behaviors) and parental perceptions of child difficulty.","['toddlers presenting with behavioral issues', 'Children', 'Aged 14-24 Months', 'Sixty-six mother-toddler dyads ', 'Parent-Child Interaction Therapy with Toddlers', 'Child  M age = 19.13 months; 63% male']",[],"['positive parenting skills and decreases in negative parenting skills), emotional availability (increases in parental sensitivity and parental non-intrusiveness), child behavior (decreases in externalizing and internalizing behaviors) and parental perceptions of child difficulty', 'questionnaires (Child Behavior Checklist, Edinburgh Postnatal Depression Scale, Parenting Stress Index - Short Form) and participated in a structured parent-child dyadic play-based interaction later coded using the Dyadic Parent-Child Interaction Coding System and the Emotional Availability Scales', 'parenting skills']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0222045'}]",66.0,0.0585493,"Compared to those who did not receive treatment, mother-child dyads who received the intervention showed significantly better parenting skills (increases in positive parenting skills and decreases in negative parenting skills), emotional availability (increases in parental sensitivity and parental non-intrusiveness), child behavior (decreases in externalizing and internalizing behaviors) and parental perceptions of child difficulty.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kohlhoff', 'Affiliation': 'School of Psychiatry, University of New South Wales.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morgan', 'Affiliation': 'Research Department, Karitane.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Briggs', 'Affiliation': 'Mark Wainwright Analytical Centre, University of New South Wales.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Egan', 'Affiliation': 'University of Oklahoma Health Sciences Center, University of Oklahoma.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Niec', 'Affiliation': 'Center for Children, Families, and Communities, Department of Psychology, Central Michigan University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1723599']
3288,32036610,Mixed hemodiafiltration reduces erythropoiesis stimulating agents requirement in dialysis patients: a prospective randomized study.,"BACKGROUND


Improved responsiveness to erythropoiesis stimulating agents (ESAs) in patients on on-line post-dilution hemodiafiltration (Post-HDF) compared with conventional hemodialysis (HD) was reported by some authors but challenged by others. This prospective, cross-over randomized study tested the hypothesis that an alternative infusion modality of HDF, mixed-dilution HDF (Mixed HDF), could further reduce ESAs requirement in dialysis patients compared to the traditional Post-HDF.
METHODS


One-hundred-twenty prevalent patients from 6 Dialysis Centers were randomly assigned to two six-months treatment sequences: A-B and B-A (A, Mixed HDF; B, Post-HDF). Primary outcome was comparative evaluation of ESA (darbepoetin alfa) requirement and ESA resistance. Treatments efficiency, iron and vitamins status, inflammation and nutrition parameters were monitored.
RESULTS


In sequence A, darbepoetin requirement decreased during Mixed HDF from 29.5 to 23.7 µg/month and increased significantly during Post-HDF (32.3 µg/month at 6th month) while, in sequence B, it increased during Post-HDF from 38.2 to 43.7 µg/month and decreased during Mixed HDF (23.9 µg/month at 6th month). Overall, EPO doses at 6 months on Mixed and Post-HDF were 23.8 and 38.4 µg/month, respectively, P < 0.01. A multiple linear model confirmed that Mixed HDF vs Post-HDF reduced significantly ESA requirement and ESA resistance (P < 0.0001), by a mean of 29% (CI 23-35%) in the last three months of the observation periods.
CONCLUSIONS


Mixed HDF decreased darbepoetin-alfa requirement in dialysis patients. This might help preventing the untoward side effects of high ESA doses, besides having a remarkable economic impact. Additional evidence is needed to confirm this potential benefit of Mixed-HDF.",2020,"A multiple linear model confirmed that Mixed HDF vs Post-HDF reduced significantly ESA requirement and ESA resistance (P < 0.0001), by a mean of 29% (CI 23-35%) in the last three months of the observation periods.
","['dialysis patients', 'One-hundred-twenty prevalent patients from 6 Dialysis Centers']","['erythropoiesis stimulating agents (ESAs', 'conventional hemodialysis (HD', 'HDF, mixed-dilution HDF (Mixed HDF', 'Mixed hemodiafiltration']","['Treatments efficiency, iron and vitamins status, inflammation and nutrition parameters', 'darbepoetin-alfa requirement', 'darbepoetin requirement decreased during Mixed HDF', 'comparative evaluation of ESA (darbepoetin alfa) requirement and ESA resistance', 'ESA requirement and ESA resistance']","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0079240', 'cui_str': 'Dilution Technics'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3472649', 'cui_str': 'ESAS'}]",120.0,0.0169487,"A multiple linear model confirmed that Mixed HDF vs Post-HDF reduced significantly ESA requirement and ESA resistance (P < 0.0001), by a mean of 29% (CI 23-35%) in the last three months of the observation periods.
","[{'ForeName': 'Luciano A', 'Initials': 'LA', 'LastName': 'Pedrini', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy. Luciano.pedrini@fmc-ag.com.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Comelli', 'Affiliation': 'Department of Brain and Behavioural Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Pio', 'Initials': 'P', 'LastName': 'Ruggiero', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Feliciani', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Manfrini', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Cozzi', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Castellano', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Pezzotta', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gatti', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Arazzi', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Auriemma', 'Affiliation': 'Biochemistry Unit, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'di Benedetto', 'Affiliation': 'Medical Coordination NephroCare, Naples, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Stuard', 'Affiliation': 'Fresenius Medical Care, Clinical and Therapeutical Governance, Bad Homburg, Germany.'}]",Journal of nephrology,['10.1007/s40620-020-00709-0']
3289,32063238,Effects of a simple reminiscence intervention program on the reminiscence functions in older adults.,"OBJECTIVES


Reminiscence promotes the acceptance of oneself and others, a sense of meaning, and the integration of the present and the past. The currently accepted classification contains eight reminiscence functions grouped in three broader functions: self-positive functions (identity, problem-solving, and death preparation); self-negative functions (bitterness revival, boredom reduction, and intimacy maintenance); and prosocial functions (conversation and teach-inform). The main objective of this study was to investigate how the eight dimensions change over time in a sample of healthy older adults after an intervention based on simple reminiscence and subsequent follow-up.
DESIGN


Participants were randomly assigned to the treatment or control group.
SETTING


Participants were evaluated individually before, immediately after, and 3 months after the intervention.
PARTICIPANTS


Participants included 139 healthy older adults (71 intervention group and 68 control group).
INTERVENTION


Ten weekly sessions lasting 2 hours each were administered, based on a simple reminiscence program.
MEASUREMENTS


Participants were assessed with the Reminiscence Functions Scale.
RESULTS


After the intervention, in the treatment group, there was a significant increase in the self-positive functions of problem-solving and death preparation, and these effects were maintained even at the follow-up; there was a significant reduction in the self-negative functions of bitterness revival and intimacy maintenance; and there was a significant increase in the prosocial function of conversation.
CONCLUSIONS


When applying an intervention based on reminiscence, it is important to evaluate how it influences these functions because this information can help us to modify the objectives of the intervention and increase its effectiveness.",2021,"After the intervention, in the treatment group, there was a significant increase in the self-positive functions of problem-solving and death preparation, and these effects were maintained even at the follow-up; there was a significant reduction in the self-negative functions of bitterness revival and intimacy maintenance; and there was a significant increase in the prosocial function of conversation.
","['Participants included 139 healthy older adults (71 intervention group and 68 control group', 'older adults', 'healthy older adults after an intervention based on simple reminiscence and subsequent follow-up']",['simple reminiscence intervention program'],"['prosocial function of conversation', 'Reminiscence Functions Scale', 'self-negative functions of bitterness revival and intimacy maintenance', 'self-positive functions of problem-solving and death preparation']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0222045'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0542301', 'cui_str': 'Feeling bitter (finding)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",139.0,0.0188862,"After the intervention, in the treatment group, there was a significant increase in the self-positive functions of problem-solving and death preparation, and these effects were maintained even at the follow-up; there was a significant reduction in the self-negative functions of bitterness revival and intimacy maintenance; and there was a significant increase in the prosocial function of conversation.
","[{'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Satorres', 'Affiliation': 'Department of Developmental Psychology, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Iraida', 'Initials': 'I', 'LastName': 'Delhom', 'Affiliation': 'Universidad Internacional de Valencia, Valencia, Spain.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Meléndez', 'Affiliation': 'Department of Developmental Psychology, University of Valencia, Valencia, Spain.'}]",International psychogeriatrics,['10.1017/S1041610220000174']
3290,30290276,Mobile health intervention for self-management of adolescent chronic pain (WebMAP mobile): Protocol for a hybrid effectiveness-implementation cluster randomized controlled trial.,"INTRODUCTION


Approximately 5-8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, most youth do not have access to psychological intervention. Our prior studies demonstrate that an existing internet-delivered pain self-management program (WebMAP) can reduce barriers to care, is feasible, acceptable, and is effective in reducing pain-related disability in youth with chronic pain. The current trial seeks to: 1) determine the effectiveness of a mobile app version of WebMAP for improving patient pain-related outcomes, and 2) evaluate a novel implementation strategy to maximize the public health impact of the intervention including the determination of adoption, reach, and sustainability of WebMAP in specialty clinics serving children with chronic pain in the United States.
METHODS


This hybrid effectiveness-implementation cluster randomized controlled trial employs a stepped wedge design in which the WebMAP mobile intervention is sequentially implemented in 8 specialty pain clinics following a usual care period. This trial aims to enroll a minimum of 120 youth (ages 10-17) who have chronic pain. Outcome analyses will determine effectiveness of treatment on adolescent pain-related outcomes as well as public health impact via reach, adoption, implementation, and maintenance.
CONCLUSIONS


This trial examines an innovative approach to evaluate a technology-delivered pain self-management program for youth with chronic pain. Findings are expected to yield a strategic approach for delivering a digital pain management program for youth with chronic pain that can be sustained in clinical settings. Clinical Trial Registration #: NCT03332563.",2018,"Our prior studies demonstrate that an existing internet-delivered pain self-management program (WebMAP) can reduce barriers to care, is feasible, acceptable, and is effective in reducing pain-related disability in youth with chronic pain.","['8 specialty pain clinics following a usual care period', 'youth with chronic pain', 'specialty clinics serving children with chronic pain in the United States', '120 youth (ages 10-17) who have chronic pain', 'adolescent chronic pain (WebMAP mobile']","['mobile app version of WebMAP', 'existing internet-delivered pain self-management program (WebMAP', 'technology-delivered pain self-management program', 'Mobile health intervention']","['severe chronic pain and disability', 'adolescent pain-related outcomes as well as public health impact via reach, adoption, implementation, and maintenance']","[{'cui': 'C0242936', 'cui_str': 'Pain Centers'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",,0.250349,"Our prior studies demonstrate that an existing internet-delivered pain self-management program (WebMAP) can reduce barriers to care, is feasible, acceptable, and is effective in reducing pain-related disability in youth with chronic pain.","[{'ForeName': 'Tonya M', 'Initials': 'TM', 'LastName': 'Palermo', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, University of Washington School of Medicine, United States; Center for Child Health, Behavior & Development, Seattle Children's Research Institute, United States. Electronic address: tonya.palermo@seattlechildrens.org.""}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'de la Vega', 'Affiliation': ""Center for Child Health, Behavior & Development, Seattle Children's Research Institute, United States.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Dudeney', 'Affiliation': ""Center for Child Health, Behavior & Development, Seattle Children's Research Institute, United States.""}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Murray', 'Affiliation': ""Center for Child Health, Behavior & Development, Seattle Children's Research Institute, United States.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Law', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, University of Washington School of Medicine, United States; Center for Child Health, Behavior & Development, Seattle Children's Research Institute, United States.""}]",Contemporary clinical trials,['10.1016/j.cct.2018.10.003']
3291,28698009,"A randomised, open-label, phase 2 study of the IDO1 inhibitor epacadostat (INCB024360) versus tamoxifen as therapy for biochemically recurrent (CA-125 relapse)-only epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer.","OBJECTIVE


Indoleamine 2,3-dioxygenase-1 (IDO1) is a key regulator of immune tolerance in ovarian cancer. This study investigated efficacy and safety of the IDO1 enzyme inhibitor epacadostat versus tamoxifen in patients with biochemical-only recurrence (CA-125 elevation) following complete remission after first-line chemotherapy for advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer.
METHODS


In this open-label, phase 2 study (NCT01685255), patients were randomised 1:1 to epacadostat 600mg or tamoxifen 20mg twice daily for successive 28-day cycles and stratified by time since completion of first-line chemotherapy to first CA-125 elevation (3 to <12 or ≥12months). The primary endpoint was investigator-assessed progression-free survival (PFS; RECIST v1.1). Secondary endpoints included CA-125 response (Gynecologic Cancer InterGroup criteria), overall survival, safety, and tolerability.
RESULTS


The study was terminated primarily due to slow accrual and lack of evidence of superiority. Median PFS was 3.75months for epacadostat (n=22) versus 5.56months for tamoxifen (n=20; HR, 1.34 [95% CI, 0.58-3.14]; P=0.54). Of evaluable patients, 1 (5.0%) epacadostat and 3 (15.8%) tamoxifen patients had confirmed CA-125 responses. The most common treatment-emergent adverse event was fatigue (epacadostat, 36.4%; tamoxifen, 40.0%). Immune-related adverse events, observed with epacadostat only, were primarily rash (18.2%) and pruritus (9.1%). Epacadostat pharmacokinetics/pharmacodynamics were consistent with its known mechanism of action. IDO1 expression was observed in 94% of archival tumour samples.
CONCLUSIONS


This first report of immunotherapy evaluation in biochemical-only relapse ovarian cancer and of IDO1 inhibitor monotherapy in ovarian cancer found no significant difference in efficacy between epacadostat and tamoxifen. Epacadostat was generally well tolerated.",2017,"The most common treatment-emergent adverse event was fatigue (epacadostat, 36.4%; tamoxifen, 40.0%).","['ovarian cancer', 'biochemically recurrent (CA-125 relapse)-only epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer', 'patients with biochemical-only recurrence (CA-125 elevation) following complete remission after first-line chemotherapy for advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer']","['IDO1 inhibitor epacadostat (INCB024360) versus tamoxifen', 'Indoleamine 2,3-dioxygenase-1 (IDO1', 'epacadostat 600mg or tamoxifen', 'IDO1 enzyme inhibitor epacadostat versus tamoxifen', 'tamoxifen']","['tolerated', 'CA-125 responses', 'CA-125 response (Gynecologic Cancer InterGroup criteria), overall survival, safety, and tolerability', 'investigator-assessed progression-free survival', 'IDO1 expression', 'Median PFS']","[{'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0201549', 'cui_str': 'CA 125 measurement (procedure)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0948303', 'cui_str': 'Peritoneal carcinoma'}, {'cui': 'C0238122', 'cui_str': 'Fallopian Tube Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C1564138', 'cui_str': 'Indoleamine-Pyrrole 2,3,-Dioxygenase'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0014432', 'cui_str': 'Enzyme Inhibitors'}]","[{'cui': 'C0201549', 'cui_str': 'CA 125 measurement (procedure)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.175163,"The most common treatment-emergent adverse event was fatigue (epacadostat, 36.4%; tamoxifen, 40.0%).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kristeleit', 'Affiliation': 'University College London (UCL) Cancer Institute, UCL, London, UK. Electronic address: r.kristeleit@ucl.ac.uk.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Davidenko', 'Affiliation': 'Clinical Oncological Dispensary #1, Healthcare Department of Krasnodar Region, Krasnodar, Russia.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Shirinkin', 'Affiliation': 'Orenburg Regional Clinical Oncology Dispensary, Orenburg, Russia.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'El-Khouly', 'Affiliation': 'University College London (UCL) Cancer Institute, UCL, London, UK.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'MI Dnipropetrovsk City Multidiscipline Clinical Hospital No. 4, SI Dnipropetrovsk Medical Academy under the MOH of Ukraine, Dnipropetrovsk, Ukraine.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Goodheart', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Gorbunova', 'Affiliation': 'N. N. Blokhin Russian Cancer Research, Center of RAMS, Moscow, Russia.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Penning', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Jack G', 'Initials': 'JG', 'LastName': 'Shi', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Newton', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Yufan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Maleski', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Leopold', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Schilder', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2017.07.005']
3292,31978403,Forgetting in Alzheimer's disease: Is it fast? Is it affected by repeated retrieval?,"OBJECTIVES


Whether people with Alzheimer's Disease present with accelerated long term forgetting compared to healthy controls is still debated. Typically, accelerated long term forgetting implies testing the same participants repeatedly over several delays. This testing method raises the issue of confounding repetition effects with forgetting rates. We used a novel procedure to disentangle the two effects.
METHODS


Four short stories were presented during an initial in-person assessment of 40 patients with Alzheimer's Disease and 42 age-matched healthy controls. Our aim was for participants to reach a score of 70% correct (9 out of 13 questions) at encoding. If this criterion was not achieved after the first trial, the four stories were presented again (in a different order); participants took the 1 min filler task again and were then retested. We repeated this process until participants reached the 70% criterion or to a maximum of four trials. Cued recall memory tests were completed during follow-up telephone call(s) at different delay intervals. Study material was presented only at encoding, then probed with different question sets on all other delays. Each question set tested different sub-parts of the material. The experiment employed a mixed design. Participants were randomly allocated to either a condition without retrieval practice or a condition with retrieval practice. Participants in the condition without retrieval practice were only tested at two delays: post encoding filled delay and at one month. Participants in the condition with retrieval practice were tested at four delays: post encoding filled delay, one day, one week and one month. Our methodological design allowed us to separate the effects of retesting from the effects of delay.
RESULTS


Alzheimer's Disease patients showed a significant encoding deficit reflected in the higher number of trials required to reach criterion. Using Linear Mixed Models, we found no group by delay interactions between the post encoding filled delay retrieval and one month delays, with Alzheimer's Disease groups having a similar decline in performance to healthy controls, irrespective of testing condition. Significant condition by delay interactions were found for both groups (Alzheimer's Disease and healthy controls), with better performance at one month in the condition with retrieval practice.
CONCLUSIONS


Our data showed that Alzheimer's Disease is not characterised by accelerated long term forgetting, patients in our sample forgot at the same rate as healthy controls. Given the additional trials required by Alzheimer's patients to reach the 70% correct criterion, their memory impairment appears to be one of encoding. Moreover, Alzheimer's Disease patients benefited from repeated testing to the same extent as healthy controls. Due to our methodological design, we were also able to show that performance improved under repeated testing conditions, even with partial testing (sampling different features from each narrative on every test session/delay) in both healthy controls and Alzheimer's Disease.",2020,"Significant condition by delay interactions were found for both groups (Alzheimer's Disease and healthy controls), with better performance at one month in the condition with retrieval practice.
","[""people with Alzheimer's Disease"", ""Alzheimer's Disease patients"", ""Four short stories were presented during an initial in-person assessment of 40 patients with Alzheimer's Disease and 42 age-matched healthy controls"", ""Alzheimer's disease""]",['condition without retrieval practice or a condition with retrieval practice'],['Cued recall memory tests'],"[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0522965,"Significant condition by delay interactions were found for both groups (Alzheimer's Disease and healthy controls), with better performance at one month in the condition with retrieval practice.
","[{'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Stamate', 'Affiliation': 'Human Cognitive Neuroscience, Psychology Department, University of Edinburgh, UK; University Suor Orsola Benincasa, Naples, Italy. Electronic address: s1363074@ed.ac.uk.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Logie', 'Affiliation': 'Human Cognitive Neuroscience, Psychology Department, University of Edinburgh, UK; Centre for Cognitive Ageing and Cognitive Epidemiology, University of Edinburgh, UK.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Baddeley', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, UK.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Della Sala', 'Affiliation': 'Human Cognitive Neuroscience, Psychology Department, University of Edinburgh, UK; Centre for Cognitive Ageing and Cognitive Epidemiology, University of Edinburgh, UK.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107351']
3293,26337626,Progressive multi-component home-based physical therapy for deconditioned older adults following acute hospitalization: a pilot randomized controlled trial.,"OBJECTIVE


To determine whether a progressive multicomponent physical therapy intervention in the home setting can improve functional mobility for deconditioned older adults following acute hospitalization.
DESIGN


Randomized controlled trial.
SETTING


Patient homes in the Denver, CO, metropolitan area.
PARTICIPANTS


A total of 22 homebound older adults age 65 and older (mean ± SD; 85.4 ±7.83); 12 were randomized to intervention group and 10 to the control group.
INTERVENTION


The progressive multicomponent intervention consisted of home-based progressive strength, mobility and activities of daily living training. The control group consisted of usual care rehabilitation.
MEASUREMENTS


A 4-meter walking speed, modified Physical Performance Test, Short Physical Performance Battery, 6-minute walk test.
RESULTS


At the 60-day time point, the progressive multicomponent intervention group had significantly greater improvements in walking speed (mean change: 0.36 m/s vs. 0.14 m/s, p = 0.04), modified physical performance test (mean change: 6.18 vs. 0.98, p = 0.02) and Short Physical Performance Battery scores (mean change: 2.94 vs. 0.38, p = 0.02) compared with the usual care group. The progressive multicomponent intervention group also had a trend towards significant improvement in the 6-minute walk test at 60 days (mean change: 119.65 m vs. 19.28 m; p = 0.07). No adverse events associated with intervention were recorded.
CONCLUSIONS


The progressive multicomponent intervention improved patient functional mobility following acute hospitalization more than usual care. Results from this study support the safety and feasibility of conducting a larger randomized controlled trial of progressive multicomponent intervention in this population. A more definitive study would require 150 patients to verify these conclusions given the effect sizes observed.",2016,"At the 60-day time point, the progressive multicomponent intervention group had significantly greater improvements in walking speed (mean change: 0.36 m/s vs. 0.14 m/s, p = 0.04), modified physical performance test (mean change: 6.18 vs. 0.98, p = 0.02) and Short Physical Performance Battery scores (mean change: 2.94 vs. 0.38, p = 0.02) compared with the usual care group.","['Patient homes in the Denver, CO, metropolitan area', 'deconditioned older adults following acute hospitalization', 'A total of 22 homebound older adults age 65 and older (mean ± SD; 85.4 ±7.83); 12']","['usual care rehabilitation', 'progressive multicomponent physical therapy intervention', 'progressive multicomponent intervention', 'progressive multicomponent intervention consisted of home-based progressive strength, mobility and activities of daily living training', 'Progressive multi-component home-based physical therapy']","['modified physical performance test', '6-minute walk test', 'patient functional mobility', 'functional mobility', 'walking speed', 'Short Physical Performance Battery scores', '4-meter walking speed, modified Physical Performance Test, Short Physical Performance Battery, 6-minute walk test']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242798', 'cui_str': 'Home-Bound Persons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score (observable entity)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}]",150.0,0.0965383,"At the 60-day time point, the progressive multicomponent intervention group had significantly greater improvements in walking speed (mean change: 0.36 m/s vs. 0.14 m/s, p = 0.04), modified physical performance test (mean change: 6.18 vs. 0.98, p = 0.02) and Short Physical Performance Battery scores (mean change: 2.94 vs. 0.38, p = 0.02) compared with the usual care group.","[{'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Stevens-Lapsley', 'Affiliation': 'Physical Therapy Program, University of Colorado, Aurora, CO, USA Jennifer.stevens-lapsley@ucdenver.edu.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Loyd', 'Affiliation': 'Physical Therapy Program, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Falvey', 'Affiliation': 'Physical Therapy Program, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Figiel', 'Affiliation': 'Physical Therapy Program, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Kittelson', 'Affiliation': 'Physical Therapy Program, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Ethan U', 'Initials': 'EU', 'LastName': 'Cumbler', 'Affiliation': 'Department of Geriatrics, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Kathleen K', 'Initials': 'KK', 'LastName': 'Mangione', 'Affiliation': 'Department of Physical Therapy, Arcadia University, Glenside, PA, USA.'}]",Clinical rehabilitation,['10.1177/0269215515603219']
3294,32006087,"Efficacy of anticonvulsant ethosuximide for major depressive disorder: a randomized, placebo-control clinical trial.","Results of a preclinical study suggested that the anticonvulsant drug ethosuximide may elicit ketamine-like rapid-acting antidepressant actions. We evaluated the antidepressant efficacy of ethosuximide versus placebo in non-medicated adult patients with major depressive disorder (MDD). This randomized, double-blind, placebo-controlled trial included patients at three mental health centers in China. Eighty eligible adults (aged 18-65 years) met the DSM-5 criteria for MDD. Patients in the acute single study received three doses (500, 1000, or 1500 mg) of ethosuximide or placebo. Patients in the repeated study received ethosuximide (1500 mg/day) or placebo for 2 weeks. The Hamilton Depression Rating Scale (HAM-D), the Montgomery-Åsberg Depression Rating Scale (MADRS), and the Hamilton Anxiety Rating Scale were used to assess antidepressant and antianxiety responses to ethosuximide. No significant reductions in depression and anxiety rating scale scores were observed after a single oral administration of ethosuximide, in comparison with placebo. Furthermore, patients receiving ethosuximide for 2 weeks did not show reductions in depression and anxiety rating scale scores. There were no serious adverse events. Responses to the study's primary and secondary outcome measures, the clinician-rated HAM-D and MADRS, showed no change from baseline to the end of treatment, with either ethosuximide or placebo. These results suggest that ethosuximide does not produce ketamine-like robust antidepressant actions in adult patients with MDD.",2021,"No significant reductions in depression and anxiety rating scale scores were observed after a single oral administration of ethosuximide, in comparison with placebo.","['adult patients with MDD', 'Eighty eligible adults (aged 18-65\xa0years) met the DSM-5 criteria for MDD', 'major depressive disorder', 'patients at three mental health centers in China', 'non-medicated adult patients with major depressive disorder (MDD']","['ethosuximide', 'ethosuximide versus placebo', 'placebo', 'ethosuximide or placebo', 'anticonvulsant ethosuximide']","['clinician-rated HAM-D and MADRS', 'antidepressant efficacy', 'serious adverse events', 'Hamilton Depression Rating Scale (HAM-D), the Montgomery-Åsberg Depression Rating Scale (MADRS), and the Hamilton Anxiety Rating Scale', 'depression and anxiety rating scale scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0015043', 'cui_str': 'Ethosuximide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003286', 'cui_str': 'Anticonvulsive Agents'}]","[{'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",80.0,0.353079,"No significant reductions in depression and anxiety rating scale scores were observed after a single oral administration of ethosuximide, in comparison with placebo.","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Chaohu Hospital of Anhui Medical University, Hefei, 238000, Anhui, China. 543918@163.com.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': 'Anhui Mental Health Center, Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Department of Psychiatry, Chaohu Hospital of Anhui Medical University, Hefei, 238000, Anhui, China.'}, {'ForeName': 'Jianbin', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Department of Clinical Psychology, Wuxi Mental Health Center, Nanjing Medical University, Wuxi, Jiangsu, China.'}, {'ForeName': 'Guanchen', 'Initials': 'G', 'LastName': 'Gai', 'Affiliation': 'Department of Clinical Psychology, Wuxi Mental Health Center, Nanjing Medical University, Wuxi, Jiangsu, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Psychology, Wuxi Mental Health Center, Nanjing Medical University, Wuxi, Jiangsu, China.'}, {'ForeName': 'Leiming', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Department of Clinical Psychology, Wuxi Mental Health Center, Nanjing Medical University, Wuxi, Jiangsu, China.'}, {'ForeName': 'Fuquan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Psychology, Wuxi Mental Health Center, Nanjing Medical University, Wuxi, Jiangsu, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Tao', 'Affiliation': 'Anhui Mental Health Center, Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Huanzhong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Chaohu Hospital of Anhui Medical University, Hefei, 238000, Anhui, China.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Division of Clinical Neuroscience, Chiba University Center for Forensic Mental Health, Chiba, Japan.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Psychology, Wuxi Mental Health Center, Nanjing Medical University, Wuxi, Jiangsu, China.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-020-01103-4']
3295,31997237,Effectiveness and Safety Evaluation of Qixiong Zhongzi Decoction () in Idiopathic Asthenozoospermia Treatment: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the clinical effectiveness and safety of the Chinese medicine (CM) Qixiong Zhongzi Decoction (, QZD) in the treatment of patients with idiopathic asthenozoospermia.
METHODS


A total number of 66 patients with idiopathic asthenozoospermia were included and randomly divided into treatment and control groups by SAS-generated code from January 2015 to August 2016, 33 patients in each group. Patients in the treatment group were administered with 150 mL of QZD twice a day, whereas those in the control group were given 1 g of levocarnitine oral liquid twice a day. The two groups received the indicated medication for 12 weeks and were then followed up for 4 weeks. The primary outcome was sperm motility, and the secondary therapeutic indices were sperm volume, density, pregnancy probability, and CM syndrome score. The comparison between groups was carried out at 4, 8 and 12 weeks, respectively. The safety was determined before and after treatment.
RESULTS


(1) Drop-off: 5 cases (7.58%) were lost after treatment (2 from the treatment group and 3 from the control group). (2) Primary outcomes: after 8- and 12-week treatment, the progressive sperms in the two groups were significantly higher than the baseline (all P<0.05); however, the treatment group showed greater improvement compared with the control group at 12-week treatment (22.7% ± 9.0% vs. 14.1% ±8.8%, P<0.05). The increasement of non-progressive grade sperms at both groups was observed at 8- and 12-week treatment with statistical difference (all P<0.05), however, the treatment group showed remarkable improvement compared with the control group at 12-week treatment (38.7% ±14.1% vs. 26.2% ±15.4%, P<0.05). (3) Secondary outcomes: no significant statistical differences were found in semen volume and density (4, 8, and 12-week treatment) and pregnancy probability of patients' wives (12-week treatment) between two groups (all P>0.05), however, the CM syndrome score of the treatment group significantly declined compared with baseline level at each time points (all P<0.05). (4) Safety: no obvious side reactions were found during the treatment in both groups.
CONCLUSION


QZD could improve the progressive and non-progressive grade sperm in the treatment of idiopathic asthenozoospermia. It is safe with no obvious side effects.",2020,"The increasement of non-progressive grade sperms at both groups was observed at 8- and 12-week treatment with statistical difference (all P<0.05), however, the treatment group showed remarkable improvement compared with the control group at 12-week treatment (38.7% ±14.1% vs. 26.2% ±15.4%, P<0.05).","['patients with idiopathic asthenozoospermia', 'Idiopathic Asthenozoospermia Treatment', '66 patients with idiopathic asthenozoospermia']","['QZD', 'Qixiong Zhongzi Decoction (, QZD', 'Chinese medicine (CM', 'levocarnitine oral liquid twice a day', 'Qixiong Zhongzi Decoction ']","['no obvious side reactions', 'increasement of non-progressive grade sperms', 'sperm motility, and the secondary therapeutic indices were sperm volume, density, pregnancy probability, and CM syndrome score', 'CM syndrome score', 'progressive sperms', ""semen volume and density (4, 8, and 12-week treatment) and pregnancy probability of patients' wives""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C4082176', 'cui_str': 'Asthenozoospermia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C1273619', 'cui_str': 'Oral Liquid Product'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C3839460', 'cui_str': 'Non-progressive'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0037848', 'cui_str': 'Sperm Motility'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0678793', 'cui_str': 'Therapeutic Index'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242665', 'cui_str': 'Wife (person)'}]",,0.0162862,"The increasement of non-progressive grade sperms at both groups was observed at 8- and 12-week treatment with statistical difference (all P<0.05), however, the treatment group showed remarkable improvement compared with the control group at 12-week treatment (38.7% ±14.1% vs. 26.2% ±15.4%, P<0.05).","[{'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Qing-He', 'Initials': 'QH', 'LastName': 'Gao', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Geng', 'Affiliation': 'Department of Andrology, The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Han', 'Affiliation': 'Department of Andrology, Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Jia-You', 'Initials': 'JY', 'LastName': 'Zhao', 'Affiliation': 'Graduate School, China Academy of Chinese Medical Sciences, Beijing, 100700, China.'}, {'ForeName': 'Guo-Jin', 'Initials': 'GJ', 'LastName': 'Yu', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Ji-Wei', 'Initials': 'JW', 'LastName': 'Zhang', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Chun-Sheng', 'Initials': 'CS', 'LastName': 'Song', 'Affiliation': 'Graduate School, China Academy of Chinese Medical Sciences, Beijing, 100700, China. sonchun@vip.163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3211-7']
3296,32339032,SAFETY AND EFFICACY OF DDP4-INHIBITORS FOR MANAGEMENT OF HOSPITALIZED GENERAL MEDICINE AND SURGERY PATIENTS WITH TYPE 2 DIABETES.,"Background:  DPP4-inhibitors (DPP4-i) have been shown to be effective for the management of inpatient diabetes. We report pooled data from three prospective studies using DPP4-i in general medicine and surgery patients with type 2 diabetes (T2D).  Research Design and Methods:  We combined data from three randomized studies comparing DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen. Medicine (n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with diet, oral agents or low-dose insulin therapy were included. Patients received DPP4-i alone (n=144), DPP4-i plus basal insulin (n=158) or basal bolus regimen (n=283). All groups received correctional doses with rapid-acting insulin for BG >140mg/dl. The primary endpoint was differences in mean daily BG between groups. Secondary endpoints included differences in hypoglycemia and hospital complications.  Results:  There were no differences in mean hospital daily BG among patients treated with DPP4-i alone (170±37 mg/dl), DPP4-i plus basal (172±42 mg/dl) or basal bolus (172±43 mg/dl), p=0.94; or in the percentage of BG readings within target of 70-180 mg/dl (63±32%, 60±31% and 64±28% respectively, p=0.42). There were no differences in length of stay or complications, but hypoglycemia was less common with DPP4-i alone (2%) compared to DPP4-i plus basal (9%) and basal bolus (10%), p=0.004.  Conclusion:  Treatment with DPP4-i alone or in combination with basal insulin is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin re gimen in general medicine and surgery patients with T2D.",2020,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"['general medicine and surgery patients with T2D', 'general medicine and surgery patients with type 2 diabetes (T2D', 'n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with']","['DPP4-i alone', 'correctional doses with rapid-acting insulin for BG >140mg/dl', 'DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen', ':  DPP4-inhibitors (DPP4-i', 'diet, oral agents or low-dose insulin therapy', 'DPP4-i plus basal insulin (n=158) or basal bolus regimen', 'DPP4-i', 'DPP4-i alone or in combination with basal insulin', 'Medicine']","['hypoglycemia and hospital complications', 'mean daily BG', 'mean hospital daily BG', 'length of stay or complications, but hypoglycemia', 'hypoglycemia']","[{'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0952002,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lorenzo-González', 'Affiliation': 'From: Department of Endocrinology and Nutrition, Hospital Universitario Nuestra Señora de La Candelaria, Tenerife, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Atienza-Sánchez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Príncipe de Asturias, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reyes-Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Schoolf of Public Health, Emory University.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2019-0481']
3297,31512101,A Prospective Randomized Trial Comparing Jejunostomy and Nasogastric Feeding in Minimally Invasive McKeown Esophagectomy.,"BACKGROUND


Early postoperative enteral nutrition is recommended for patients undergoing esophagectomy; however, the optimum method of tube feeding remains controversial. Thus, the aim of this study is to assess two common enteral nutrition methods after minimally invasive McKeown esophagectomy.
METHODS


A randomized controlled trial was performed with 120 patients who underwent minimally invasive McKeown esophagectomy from January 2017 to December 2018. The patients were randomly divided so that 58 patients were in the jejunostomy feeding (JF) group and 62 patients were in the nasogastric feeding (NF) group. The postoperative outcomes, including complications, nutritional status, quality of life, and survival rate, were studied and used as the main parameters to compare the abovementioned tube feeding methods.
RESULTS


The incidence of overall complications was equivalent between the two groups (P = 0.625), except for bowel obstruction (which occurred 4 times in the JF group but did not occur in the NF group). In the first month after surgery (postoperative month 1, POM1), a significantly higher body mass index (BMI) was observed in the JF group (23.6 ± 3.2) than in the NF group (20.9 ± 3.5, P = 0.032). The global quality-of-life scores were better in the JF group than in the NF group (P < 0.001). In addition, there were no significant differences between the two groups in terms of disease-free survival (DFS) (P = 0.816) and overall survival (OS) (P = 0.564).
CONCLUSIONS


Compared with NF, JF provides more safety, efficacy, and utility as nutritional support for minimally invasive McKeown esophagectomy patients who have a high incidence of anastomotic leakage. However, the higher risk of intestinal obstruction after JF requires attention.",2020,"The incidence of overall complications was equivalent between the two groups (P = 0.625), except for bowel obstruction (which occurred 4 times in the JF group but did not occur in the NF group).","['120 patients who underwent', 'minimally invasive McKeown esophagectomy patients who have a high incidence of anastomotic leakage', 'from January 2017 to December 2018', 'Minimally Invasive McKeown Esophagectomy', 'patients undergoing esophagectomy']","['nasogastric feeding (NF', 'jejunostomy feeding (JF', 'NF, JF', 'Jejunostomy and Nasogastric Feeding', 'minimally invasive McKeown esophagectomy']","['disease-free survival (DFS', 'incidence of overall complications', 'postoperative outcomes, including complications, nutritional status, quality of life, and survival rate', 'overall survival (OS', 'body mass index (BMI', 'global quality-of-life scores', 'bowel obstruction']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0472888', 'cui_str': 'McKeown esophagectomy (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0192715', 'cui_str': 'Jejunostomy feeding (regime/therapy)'}, {'cui': 'C0022377', 'cui_str': 'Jejunostomy'}, {'cui': 'C0192456', 'cui_str': 'Nasogastric tube feeding'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0472888', 'cui_str': 'McKeown esophagectomy (procedure)'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0034380'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}]",,0.0333319,"The incidence of overall complications was equivalent between the two groups (P = 0.625), except for bowel obstruction (which occurred 4 times in the JF group but did not occur in the NF group).","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Tao', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Shaojin', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Zhengzheng', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'You', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China. dongxusuda@126.com.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04390-y']
3298,31100155,MUST Beg to Differ.,"The authors provide a significant interpretation of the National Eye Institute-sponsored Multicenter Uveitis Steroid Treatment study, in which patients with severe, non-infectious intermediate, posterior, or panuveitis were randomly assigned to receive local treatment using the sutured intravitreal fluocinolone acetonide implant or systemic treatment consisting of oral steroids and conventional steroid-sparing immunosuppression, with a primary outcome of visual acuity at 2 years of follow-up. The authors also present evidence-based guidance for the treatment of noninfectious posterior segment involving uveitis. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:266-268.].",2019,The authors also present evidence-based guidance for the treatment of noninfectious posterior segment involving uveitis.,"['patients with severe, non-infectious intermediate, posterior, or panuveitis']",['fluocinolone acetonide implant or systemic treatment consisting of oral steroids and conventional steroid-sparing immunosuppression'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0030343', 'cui_str': 'Panuveitis'}]","[{'cui': 'C0016298', 'cui_str': 'Fluocinolone Acetonide'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}]",[],,0.0636471,The authors also present evidence-based guidance for the treatment of noninfectious posterior segment involving uveitis.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Albini', 'Affiliation': ''}, {'ForeName': 'Natalia F', 'Initials': 'NF', 'LastName': 'Callaway', 'Affiliation': ''}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Feuer', 'Affiliation': ''}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Careen', 'Initials': 'C', 'LastName': 'Lowder', 'Affiliation': ''}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Callanan', 'Affiliation': ''}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Galor', 'Affiliation': ''}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Goldhardt', 'Affiliation': ''}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Flynn', 'Affiliation': ''}]","Ophthalmic surgery, lasers & imaging retina",['10.3928/23258160-20190503-01']
3299,30832739,"The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment Protocol (GAP): study protocol for a randomised controlled trial.","BACKGROUND


Stillbirth rates in the United Kingdom (UK) are amongst the highest of all developed nations. The association between small-for-gestational-age (SGA) foetuses and stillbirth is well established, and observational studies suggest that improved antenatal detection of SGA babies may halve the stillbirth rate. The Growth Assessment Protocol (GAP) describes a complex intervention that includes risk assessment for SGA and screening using customised fundal-height growth charts. Increased detection of SGA from the use of GAP has been implicated in the reduction of stillbirth rates by 22%, in observational studies of UK regions where GAP uptake was high. This study will be the first randomised controlled trial examining the clinical efficacy, health economics and implementation of the GAP programme in the antenatal detection of SGA.
METHODS/DESIGN


In this randomised controlled trial, clusters comprising a maternity unit (or National Health Service Trust) were randomised to either implementation of the GAP programme, or standard care. The primary outcome is the rate of antenatal ultrasound detection of SGA in infants found to be SGA at birth by both population and customised standards, as this is recognised as being the group with highest risk for perinatal morbidity and mortality. Secondary outcomes include antenatal detection of SGA by population centiles, antenatal detection of SGA by customised centiles, short-term maternal and neonatal outcomes, resource use and economic consequences, and a process evaluation of GAP implementation. Qualitative interviews will be performed to assess facilitators and barriers to implementation of GAP.
DISCUSSION


This study will be the first to provide data and outcomes from a randomised controlled trial investigating the potential difference between the GAP programme compared to standard care for antenatal ultrasound detection of SGA infants. Accurate information on the performance and service provision requirements of the GAP protocol has the potential to inform national policy decisions on methods to reduce the rate of stillbirth.
TRIAL REGISTRATION


Primary registry and trial identifying number: ISRCTN 67698474 . Registered on 2 November 2016.",2019,"The association between small-for-gestational-age (SGA) foetuses and stillbirth is well established, and observational studies suggest that improved antenatal detection of SGA babies may halve the stillbirth rate.","['clusters comprising a maternity unit (or National Health Service Trust', 'SGA infants']","['GAP programme', 'GAP programme, or standard care']","['perinatal morbidity and mortality', 'rate of antenatal ultrasound detection of SGA', 'antenatal detection of SGA by population centiles, antenatal detection of SGA by customised centiles, short-term maternal and neonatal outcomes, resource use and economic consequences, and a process evaluation of GAP implementation', 'stillbirth rates']","[{'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}]",,0.135727,"The association between small-for-gestational-age (SGA) foetuses and stillbirth is well established, and observational studies suggest that improved antenatal detection of SGA babies may halve the stillbirth rate.","[{'ForeName': 'Matias C', 'Initials': 'MC', 'LastName': 'Vieira', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Relph', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Copas', 'Affiliation': 'Centre for Pragmatic Global Health Trials, Institute for Global Health, University College London, Gower Street, London, WC1E 6BT, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Healey', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Kirstie', 'Initials': 'K', 'LastName': 'Coxon', 'Affiliation': ""Faculty of Health, Social Care and Education, Kingston and St. George's University, 6th Floor, Hunter Wing, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Alagna', 'Affiliation': ""The Guy's and St Thomas' Charity, 9 King's Head Yard, London, SE1 1NA, UK.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Briley', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, Kensington, London, SW7 2AZ, UK.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Lawlor', 'Affiliation': 'Population Health Science, Bristol Medical School, University of Bristol, Bristol, BS8 2BL, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Lees', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, Kensington, London, SW7 2AZ, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Marlow', 'Affiliation': ""UCL Institute for Women's Health, University College London, Gower Street, London, WC1E 6BT, UK.""}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'McCowan', 'Affiliation': 'Faculty of Medical and Health Sciences, University of Auckland, Victoria Street West, Auckland, 1142, New Zealand.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Page', 'Affiliation': 'West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, Twickenham Road, Isleworth, TW7 6AF, UK.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Peebles', 'Affiliation': ""UCL Institute for Women's Health, University College London, Gower Street, London, WC1E 6BT, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Baskaran', 'Initials': 'B', 'LastName': 'Thilaganathan', 'Affiliation': ""Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, Blackshaw Road, London, SW17 0QT, UK.""}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Khalil', 'Affiliation': ""Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, Blackshaw Road, London, SW17 0QT, UK.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Dharmintra', 'Initials': 'D', 'LastName': 'Pasupathy', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK. dharmintra.pasupathy@kcl.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3242-6']
3300,31598912,Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study.,"BACKGROUND


Metabolic acidosis is associated with accelerated progression of chronic kidney disease (CKD). Whether treatment of metabolic acidosis with sodium bicarbonate improves kidney and patient survival in CKD is unclear.
METHODS


We conducted a randomized (ratio 1:1). open-label, controlled trial (NCT number: NCT01640119. www.clinicaltrials.gov ) to determine the effect in patients with CKD stage 3-5 of treatment of metabolic acidosis with sodium bicarbonate (SB) on creatinine doubling (primary endpoint), all-cause mortality and time to renal replacement therapy compared to standard care (SC) over 36-months. Parametric, non-parametric tests and survival analyses were used to assess the effect of SB on these outcomes.
RESULTS


A total of 376 and 364 individuals with mean (SD) age 67.8 (14.9) years, creatinine clearance 30 (12) ml/min, and serum bicarbonate 21.5 (2.4) mmol/l were enrolled in SB and SC, respectively. Mean (SD) follow-up was 29.6 (9.8) vs 30.3 (10.7) months in SC and SB. respectively. The mean (SD) daily doses of SB was 1.13 (0.10). 1.12 (0.11). and 1.09 (0.12) mmol/kg*bw/day in the first, second and third year of follow-up, respectively. A total of 87 participants reached the primary endpoint [62 (17.0%) in SC vs 25 (6.6%) in SB, p < 0.001). Similarly, 71 participants [45 (12.3%) in SC and 26 (6.9%) in SB, p = 0.016] started dialysis while 37 participants [25 (6.8%) in SC and 12 (3.1%) in SB, p = 0.004] died. There were no significant effect of SB on blood pressure, total body weight or hospitalizations.
CONCLUSION


In persons with CKD 3-5 without advanced stages of chronic heart failure, treatment of metabolic acidosis with sodium bicarbonate is safe and improves kidney and patient survival.",2019,"A total of 87 participants reached the primary endpoint [62 (17.0%) in SC vs 25 (6.6%) in SB, p < 0.001).","['chronic kidney disease', 'A total of 376 and 364 individuals with mean (SD) age 67.8 (14.9) years, creatinine clearance 30 (12) ml/min, and serum bicarbonate 21.5 (2.4) mmol', 'patients with CKD stage 3-5 of treatment of metabolic acidosis with']","['SB', 'sodium bicarbonate (SB', 'sodium bicarbonate', 'renal replacement therapy compared to standard care (SC']","['blood pressure, total body weight or hospitalizations', 'mean (SD) daily doses of SB', 'kidney and patient survival']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2316787', 'cui_str': 'CKD stage 3'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis (disorder)'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",71.0,0.0598872,"A total of 87 participants reached the primary endpoint [62 (17.0%) in SC vs 25 (6.6%) in SB, p < 0.001).","[{'ForeName': 'Biagio R', 'Initials': 'BR', 'LastName': 'Di Iorio', 'Affiliation': 'Nephrology and Dialysis Unit, PO ""A. Landolfi"", Solofra, Avellino, Italy. br.diiorio@gmail.com.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bellasi', 'Affiliation': 'Department of Research, Innovation, Brand Reputation, Bergamo Hospital, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Santoro', 'Affiliation': 'Dialysis and Nephrology Unit, University of Messina, Messina, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Aucella', 'Affiliation': 'Department of Nephrology and Dialysis, IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Garofano', 'Affiliation': 'Biogem, Section of Genetic and Translational Medicine, Ariano Irpino, Avellino, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ceccarelli', 'Affiliation': 'Biogem, Section of Genetic and Translational Medicine, Ariano Irpino, Avellino, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Di Lullo', 'Affiliation': 'Department of Nephrology and Dialysis, ""L. Parodi-Delfino"" Hospital, Colleferro, Roma, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Capolongo', 'Affiliation': 'Department of Translational Medical Sciences, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Di Iorio', 'Affiliation': 'Data Scientist, Landolfi Nephrology Dialysis Consultant, Solofra, Avellino, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Guastaferro', 'Affiliation': 'Department of Nephrology, ""G. Criscuoli"" Hospital, Sant\'Angelo dei Lombardi, Avellino, Italia.'}, {'ForeName': 'Giovambattista', 'Initials': 'G', 'LastName': 'Capasso', 'Affiliation': 'Department of Nephrology and Dialysis, IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of nephrology,['10.1007/s40620-019-00656-5']
3301,31804779,Impact of pretreatment interhemispheric hippocampal asymmetry on improvement in verbal learning following erythropoietin treatment in mood disorders: a randomized controlled trial,"Background


Treatment development that targets cognitive impairment is hampered by a lack of biomarkers that can predict treatment efficacy. Erythropoietin (EPO) improves verbal learning and memory in mood disorders, and this scales with an increase in left hippocampal volume. This study investigated whether pretreatment left hippocampal volume, interhemisphere hippocampal asymmetry or both influenced EPO treatment response with respect to verbal learning.
Methods


Data were available for 76 of 83 patients with mood disorders from our previous EPO trials (EPO = 37 patients; placebo = 39 patients). We performed cortical reconstruction and volumetric segmentation using FreeSurfer. We conducted multiple linear regression and logistic regression to assess the influence of left hippocampal volume and hippocampal asymmetry on EPO-related memory improvement, as reflected by change in Rey Auditory Verbal Learning Test total recall from baseline to post-treatment. We set up a corresponding exploratory general linear model in FreeSurfer to assess the influence of prefrontal cortex volume on verbal learning improvement, controlling for age, sex and total intracranial volume.
Results


At baseline, more rightward (left < right) hippocampal asymmetry — but not left hippocampal volume per se — was associated with greater effects of EPO versus placebo on verbal learning (p ≤ 0.05). Exploratory analysis indicated that a larger left precentral gyrus surface area was also associated with improvement of verbal learning in the EPO group compared to the placebo group (p = 0.002).
Limitations


This was a secondary analysis of our original EPO trials.
Conclusion


Rightward hippocampal asymmetry may convey a positive effect of EPO treatment efficacy on verbal learning.
Clinical trial registration


Clinicaltrials.gov NCT00916552",2020,"Exploratory analysis indicated that a larger left precentral gyrus surface area was also associated with improvement of verbal learning in the EPO group compared to the placebo group (p = 0.002).
","['83 patients with mood disorders from our previous EPO trials (EPO = 37 patients; placebo = 39 patients', 'mood disorders']","['Erythropoietin (EPO', 'pretreatment interhemispheric hippocampal asymmetry', 'erythropoietin treatment', 'EPO', 'placebo']","['verbal learning', 'verbal learning and memory in mood disorders', 'left hippocampal volume', 'Rey Auditory Verbal Learning Test total recall']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",83.0,0.151868,"Exploratory analysis indicated that a larger left precentral gyrus surface area was also associated with improvement of verbal learning in the EPO group compared to the placebo group (p = 0.002).
","[{'ForeName': 'Kamilla W.', 'Initials': 'KW', 'LastName': 'Miskowiak', 'Affiliation': 'From the Neurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Miskowiak, Macoveanu); the Department of Psychology, University of Copenhagen (Miskowiak); the Section of Biostatistics, Department of Public Health, University of Copenhagen (Forman); the Danish Research Centre for Magnetic Resonance (DRCMR), Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, University of Copenhagen (Siebner); the Department of Neurology, Copenhagen University Hospital Bispebjerg (Siebner); the Institute for Clinical Medicine, Faculty of Medical and Health Sciences, University of Copenhagen (Vinberg, Siebner); and the Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Kessing), Copenhagen, Denmark.'}, {'ForeName': 'Julie L.', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'From the Neurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Miskowiak, Macoveanu); the Department of Psychology, University of Copenhagen (Miskowiak); the Section of Biostatistics, Department of Public Health, University of Copenhagen (Forman); the Danish Research Centre for Magnetic Resonance (DRCMR), Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, University of Copenhagen (Siebner); the Department of Neurology, Copenhagen University Hospital Bispebjerg (Siebner); the Institute for Clinical Medicine, Faculty of Medical and Health Sciences, University of Copenhagen (Vinberg, Siebner); and the Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Kessing), Copenhagen, Denmark.'}, {'ForeName': 'Maj', 'Initials': 'M', 'LastName': 'Vinberg', 'Affiliation': 'From the Neurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Miskowiak, Macoveanu); the Department of Psychology, University of Copenhagen (Miskowiak); the Section of Biostatistics, Department of Public Health, University of Copenhagen (Forman); the Danish Research Centre for Magnetic Resonance (DRCMR), Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, University of Copenhagen (Siebner); the Department of Neurology, Copenhagen University Hospital Bispebjerg (Siebner); the Institute for Clinical Medicine, Faculty of Medical and Health Sciences, University of Copenhagen (Vinberg, Siebner); and the Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Kessing), Copenhagen, Denmark.'}, {'ForeName': 'Hartwig R.', 'Initials': 'HR', 'LastName': 'Siebner', 'Affiliation': 'From the Neurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Miskowiak, Macoveanu); the Department of Psychology, University of Copenhagen (Miskowiak); the Section of Biostatistics, Department of Public Health, University of Copenhagen (Forman); the Danish Research Centre for Magnetic Resonance (DRCMR), Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, University of Copenhagen (Siebner); the Department of Neurology, Copenhagen University Hospital Bispebjerg (Siebner); the Institute for Clinical Medicine, Faculty of Medical and Health Sciences, University of Copenhagen (Vinberg, Siebner); and the Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Kessing), Copenhagen, Denmark.'}, {'ForeName': 'Lars V.', 'Initials': 'LV', 'LastName': 'Kessing', 'Affiliation': 'From the Neurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Miskowiak, Macoveanu); the Department of Psychology, University of Copenhagen (Miskowiak); the Section of Biostatistics, Department of Public Health, University of Copenhagen (Forman); the Danish Research Centre for Magnetic Resonance (DRCMR), Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, University of Copenhagen (Siebner); the Department of Neurology, Copenhagen University Hospital Bispebjerg (Siebner); the Institute for Clinical Medicine, Faculty of Medical and Health Sciences, University of Copenhagen (Vinberg, Siebner); and the Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Kessing), Copenhagen, Denmark.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Macoveanu', 'Affiliation': 'From the Neurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Miskowiak, Macoveanu); the Department of Psychology, University of Copenhagen (Miskowiak); the Section of Biostatistics, Department of Public Health, University of Copenhagen (Forman); the Danish Research Centre for Magnetic Resonance (DRCMR), Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, University of Copenhagen (Siebner); the Department of Neurology, Copenhagen University Hospital Bispebjerg (Siebner); the Institute for Clinical Medicine, Faculty of Medical and Health Sciences, University of Copenhagen (Vinberg, Siebner); and the Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital (Kessing), Copenhagen, Denmark.'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.180205']
3302,32339048,"Endoscopic Septoplasty Versus Traditional Septoplasty for Treating Deviated Nasal Septum: A Prospective, Randomized Controlled Trial.","IMPORTANCE


This is the first randomized study to compare the quality of life of patients undergoing endoscopic septoplasty compared to traditional trans-nasal trans-speculum (TNTS) septoplasty.
OBJECTIVE


To assess the clinical outcomes and quality of life results of endoscopic versus TNTS septoplasty in patients with septal deviation and nasal obstruction.
DESIGN


A prospective, randomized controlled trial comparing 2 approaches of septoplasty: endoscopic and TNTS septoplasty performed in a single institution during the years 2016 to2017. The follow-up time was 3 months.
SETTING


A single institution study in a tertiary health-care referral center.
PARTICIPANTS


Patients who underwent primary surgery for repairing deviated nasal septum due to nasal obstruction, were older than 18 years old, and were eligible for study inclusion. Sixty-five patients were enrolled in this study, 34 in the endoscopic arm and 31 in the TNTS septoplasty arm. The overall follow-up rate was 94% at the first visit (2 weeks) and 92% at the last visit (12 weeks). Thus, the final cohort consisted of 60 patients, 30 in each study arm. The patients ranged in age from 18 to 71 years (mean 27 years) old.
MAIN OUTCOMES AND MEASURES


The primary outcome was the Sino-Nasal Outcome Test-22 (SNOT-22) score. Secondary outcomes were the Short Form 36 (SF36) QOL score and complication rates. Both questionnaires were administered at 2 weeks and 3 months following surgery.
RESULTS


Sixty patients completed this study, 30 in each study arm. Sino-Nasal Outcome Test-22 scores were improved after 3 months, with no difference between the study arms. There were no cases of septal perforation or profound bleeding requiring repeated surgery.
CONCLUSIONS AND RELEVANCE


Endoscopic septoplasty and TNTS show similar results for treatment of nasal septum deviation.  Trial Registration:  Traditional Septoplasty versus Endoscopic Septoplasty for Treating Deviated Nasal Septum, NCT02653950. https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0005ZOR&selectaction=Edit&uid=U00021YC&ts=2&cx=-2w7hot.",2021,"There were no cases of septal perforation or profound bleeding requiring repeated surgery.
","['Sixty-five patients were enrolled in this study, 34 in the endoscopic arm and 31 in the TNTS septoplasty arm', 'patients with septal deviation and nasal obstruction', 'Patients who underwent primary surgery for repairing deviated nasal septum due to nasal obstruction, were older than 18 years old, and were eligible for study inclusion', 'Sixty patients completed this study, 30 in each study arm', 'Treating Deviated Nasal Septum', 'A single institution study in a tertiary health-care referral center', 'patients undergoing', 'patients ranged in age from 18 to 71 years (mean 27 years) old']","['traditional trans-nasal trans-speculum (TNTS) septoplasty', 'Endoscopic Septoplasty Versus Traditional Septoplasty', 'https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0005ZOR&selectaction=Edit&uid=U00021YC&ts=2&cx=-2w7hot ', 'endoscopic septoplasty', 'septoplasty: endoscopic and TNTS septoplasty', 'endoscopic versus TNTS septoplasty', 'Traditional Septoplasty versus Endoscopic Septoplasty']","['quality of life', 'Sino-Nasal Outcome Test-22 scores', 'Short Form 36 (SF36) QOL score and complication rates', 'Sino-Nasal Outcome Test-22 (SNOT-22) score', 'septal perforation or profound bleeding requiring repeated surgery']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0264262', 'cui_str': 'Acquired deviated nasal septum'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1839730', 'cui_str': 'Prieto X-linked mental retardation syndrome'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",65.0,0.0846724,"There were no cases of septal perforation or profound bleeding requiring repeated surgery.
","[{'ForeName': 'Shorook', 'Initials': 'S', 'LastName': ""Na'ara"", 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Kaptzan', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, the Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gil', 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Dimitry', 'Initials': 'D', 'LastName': 'Ostrovsky', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, the Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}]","Ear, nose, & throat journal",['10.1177/0145561320918982']